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>> Craig Hales: GOOD
MORNING.

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I'M DR. CRAIG HALES.

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DIRECTOR OF NIDDK.

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ALONG WITH STRAVROULA OS 

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GAINIAN AND DR. SUSAN YANOVSKI, 

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WHO IS NOW RETIRED, I WOULD 

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LIKE TO WELCOME YOU TO THE 

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WORKSHOP ON "CAN DATA SCIENCE 

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AND A.I. DELIVER ON ITS PROMISE 

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FOR  SECTION CHIEF, 

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BIOSTATISTICS DIRECTOR, TITE  

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-- 

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I WOULD LIKE TO RECOGNIZE ALL 

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THE MEMBERS OF THE FEDERAL 

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PLANNING COMMITTEE WITH 

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REPRESENTATIVES FROM INSTITUTES 

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AND OFFICES, AS WELL AS CDC AND 

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FDA.

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THANK YOU FOR PROVIDING YOUR 

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VALUABLE INPUT WHICH HELPS 

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SHAPE THE AGENDA, SPEAKER 

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SELECTION AND WORKSHOP TOPICS.

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THE BROAD RANGE OF 

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REPRESENTATIVES ON THE PLANNING 

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COMMITTEE AFFECTS WIDE-RANGING 

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EFFECTS OF GLP-1 BASED 

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THERAPIES TO DEEPEN OUR 

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UNDERSTANDING OF THE REAL WORLD 

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BENEFITS AND RISKS.

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AS WE BEGIN THE WORKSHOP I HAVE 

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THE PLEASURE OF INTRODUCING DR. 

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GRIFFIN RODGERS, DIRECTOR OF 

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THE NATIONAL INSTITUTE OF 

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DIABETES AND DIGESTIVE AND 

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KIDNEY DISEASES OR NIDDK.

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WILL PROVIDE SOME WELCOMING 

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REMARKS.

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DR. RODGERS?

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>> Griffin Rodgers: THANK
YOU.

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AS THE DIRECTOR OF NATIONAL 

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INSTITUTE OF DIABETES AND 

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DIGESTIVE AND KIDNEY DISEASES I 

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WOULD LIKE TO WELCOME TO THIS 

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IMPORTANT WORKSHOP ON 

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LEVERAGING REAL-WORLD EVIDENCE 

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TO ASSESS GLP-1 THERAPIES.

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THEY ARE CURRENTLY APPROVED FOR 

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OBESITY AND TYPE 2 DIABETES, 

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MAJOR CARDIOVASCULAR EVENTS, 

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DIABETIC  NEPHROPATHY AND 

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OBSTRUCTIVE SLEEP APNEA.

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GROWING EVIDENCE SUGGESTS THE 

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POTENTIAL FOR THE PREVENTION OR 

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TREATMENT OF MULTIPLE CHRONIC 

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DISEASES, RANGING FROM 

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METABOLIC DYSFUNCTION STEATO 

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DPHHS HEPATITIS, OSTEOARTHRITIS 

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OF THE KNEE, ALZHEIMER'S 

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DISEASE, PARKINSON'S DISEASE, 

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SUBSTANCE OR ALCOHOL ABUSE.

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THE INFORMATION IS INCREASE 

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WITH POSSIBLE OF EXPANDED 

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INDICATIONS IN THE FUTURE.

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THE POTENTIAL PATIENT POOL FOR 

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GLP-1 DRUGS IS VERY LARGE.

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THERE'S A CRITICAL NEED TO 

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MONITOR FOR SERIOUS ADVERSE 

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EVENTS THAT ARE RARE OR TAKE 

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YEARS TO DEVELOP.

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SUCH AS ACUTE PANCREATITIS, 

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BOWEL OBSTRUCTION, MEDULLARY RY 

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THYROID CANCER, SUICIDAL 

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IDEATION OR ACUTE KIDNEY INJURY.

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MANY QUESTIONS REMAIN ABOUT THE 

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USE OF GLP-1 BASED THERAPIES IN 

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THE REAL WORLD SETTINGS.

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SUCH AS TREATMENT PATHWAYS FOR 

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SUSTAINABLE CARE, SAFETY AND 

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EFFECTIVENESS IN SUP 

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POPULATIONS, HETEROGENEITY OF 

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TREATMENT RESPONSE, ADHERENCE 

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CHALLENGES AND USE OF BROADER 

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RANGE OF CLINICAL SETTINGS AND 

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PRESENTATIONS THAN IN CLINICAL 

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TRIALS.

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AND IMPACT THAT HELP FORM 

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POLICY DEVELOPMENT SUCH AS 

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COVERAGE DECISIONS.

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REAL-WORLD DATA SOURCES 

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INCLUDING ELECTRONIC HEALTH 

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RECORDS AND CLAIMS OFF THE 

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POTENTIAL TO ANSWER MANY OF 

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THESE QUESTIONS.

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CHALLENGES UNIQUE TO GLP-1 

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BASED DRUGS, SUCH AS INADEQUATE 

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INSURANCE COVERAGE, MEDICATION 

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SHORTAGES, COMPOUNDED 

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MEDICATIONS OBTAINED OUTSIDE OF 

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THE HEALTH CARE SYSTEM AND 

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OFF-LABEL USES REQUIRE SPECIAL 

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CONSIDERATION.

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GIVEN THESE CHALLENGES AND 

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OPPORTUNITIES, WE ARE BRINGING 

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TOGETHER SCIENTISTS FROM 

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VARIOUS DISCIPLINES TO IDENTIFY 

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GAPS IN OUR KNOWLEDGE OF THE 

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BENEFITS AND RISK OF GLP-1 

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BASED THERAPIES AND HOW THEY 

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CAN BE ADDRESSED USING REAL 

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WORLD EVIDENCE TO INFORM POLICY 

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IN CLINICAL PRACTICE DECISIONS.

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I WOULD LIKE TO THANK THE 

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DISTINGUISHED SPEAKERS FOR 

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TAKING THE TIME TO COME HERE AS 

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YOUR COLLECTIVE EXPERTISE AND 

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EFFORTS WILL HELP ADVANCE 

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PROGRESS ON PREVENTION AND 

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TREATMENT ON A RANGE OF CHRONIC 

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DISEASES THAT REPRESENT 

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PRIORITIES NOT ONLY FOR NIDDK 

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BUT MANY INSTITUTES AND OFFICES 

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ACROSS NIH.

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WE LOOK FORWARD TO AN 

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ENLIGHTENING AND PRODUCTIVE 

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WORKSHOP ON THIS VERY IMPORTANT 

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TOPIC.

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AND WITH THAT, LET ME TURN IT 

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BACK OVER TO DR. HALES.

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THANK YOU.

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>> Craig Hales: THANK YOU,
DR. 

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RODGERS FOR YOUR INTRODUCTION 

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OF THE WORKSHOP.

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TO MEET THE GOALS DR. RODGERS 

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JUST OUTLINED WE HAVE ARRANGED 

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AN EXCITING AGENDA OF SPEAKERS 

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WITH AMPLE TIME FOR Q&A AND 

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MODERATED DISCUSSION.

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SO BY THE END OF THE WORKSHOP 

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PARTICIPANTS WILL HAVE 

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IDENTIFIED GAPS AND 

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OPPORTUNITIES FOR FUTURE 

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RESEARCH ON USING REAL-WORLD 

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EVIDENCE AND CLINICAL DECISION 

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MAKING AND CLINICAL GUIDELINE 

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DEVELOPMENT.

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USING REAL-WORLD EVIDENCE FOR 

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REGULATORY AND HEALTH CARE 

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POLICY DECISION MAKING.

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BEST PRACTICES FOR STUDY 

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DESIGNS ON GLP-1 BASED 

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THERAPIES USING REAL-WORLD DATA 

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AND ANALYTIC METHODS TO ADDRESS 

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ISSUES SPECIFIC TO GLP-1.

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THE AGENDA BEGINS WITH TWO 

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KEYNOTE PRESENTATIONS TO HELP 

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SET THE STAGE.

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AFTER THE KEYNOTES THERE WILL 

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BE A 15-MINUTE BREAK AND WE 

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WILL CONTINUE WITH SESSION ONE 

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ON REAL-WORLD EVIDENCE TO 

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INFORM REGULATORY DECISIONS AND 

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CLINICAL PRACTICE.

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WE WILL BREAK FOR LUNCH AT 

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12:20 UNTIL 1:10 P.M. EASTERN 

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TIME.

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THEN SESSION 2, WE WILL HEAR 

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ABOUT USING REAL WORLD IFRDS 

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FOR PUBLIC PRIVATE PAYER 

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PERSPECTIVES.

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AND AFTER THE BREAK WE WILL 

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CONTINUE WITH SESSION 3 ON 

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METHODOLOGIC APPROACHES TO 

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REAL-WORLD EVIDENCE GENERATION 

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FOR GLP-1 BASED THERAPIES.

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WE PLAN TO ADJOURN AT 4:45.

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TOMORROW WE WILL BEGIN AT 10:00 

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A.M. EASTERN TIME.

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SESSION 4, BEST PRACTICES FOR 

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STUDYING GLP-1 BASED THERAPIES 

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DEFINING EXPOSURE AND OUTCOMES.

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WE WILL BREAK FOR LUNCH 

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12:35-1:15 EASTERN TIME.

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AFTER LUNCH SESSION LED BY 

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CO-CHAIRS WHO WILL SUMMARIZE 

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RESEARCH GAPS AND OPPORTUNITIES 

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AND MODERATE A DISCUSSION WITH 

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ATTENDEES.

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THE MEETING TOMORROW WILL 

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ADJOURN AT 2:00 P.M. EASTERN 

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TIME.

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NOW FOR SOME HOUSEKEEPING 

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ANNOUNCEMENTS.

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THE MEETING IS BEING RECORDED 

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AND WILL BE POSTED TO THE NIH 

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WEBSITE.

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DANIELLE JOHNIKIN IS THE 

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MEETING HOST SO PLEASE EMAIL 

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WITH ANY TECHNICAL ISSUES.

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USE THE Q&A FUNCTION TO
ENTER 

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QUESTIONS FOR THE SPEAKERS AT 

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ANY TIME DURING THE 

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PRESENTATIONS OR MODERATED 

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DISCUSSION.

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ATTENDEES CAN UPVOTE QUESTIONS 

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IN THE Q&A.

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QUESTIONS WILL BE ANSWERED 

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DURING THE MODERATED DISCUSSION 

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FOR EACH SESSION.

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IF YOUR QUESTION IS SELECTED BY 

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THE MODERATOR, THE MEETING HOST 

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WILL ENABLE YOUR UNMUTE BUTTON 

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SO YOU CAN UNMUTE YOURSELF AND 

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ENGAGE WITH THE SPEAKERS, IF 

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YOU WISH.

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THE CHAT IS DISABLED FOR THIS 

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WORKSHOP AND THE RAISE HAND 

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FEATURE WILL NOT BE USED.

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PLEASE USE THE Q&A FUNCTION 

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INSTEAD.

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NOW I WOULD LIKE TO INTRODUCE 

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AND THANK THE CO-CHAIRS OF THE 

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WORKSHOP.

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DR. DAVID ARTERBURN, LESLIE 

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CURTIS AND DARREN TOH BRING A 

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WEALTH OF EXPERIENCE, OF 

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EPIDEMIOLOGY, PRAGMATIC 

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RESEARCH, DESIGN AND 

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COMPARATIVE RESEARCH USING 

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REAL-WORLD DATA AND WERE 

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INSTRUMENTAL DEVELOPING THE 

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GOALS AND AGENDA TOPICS.

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DR. DAVID ARTERBURN IS SENIOR 

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INVESTIGATOR, MANAGER 

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INVESTIGATIVE SCIENCES DIVISION 

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AT KAISER PERMANENTE IN 

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WASHINGTON HEALTH RESEARCH 

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INSTITUTE.

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OUTCOMES OF OBESITY TREATMENT, 

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AND IMPLEMENTATION OF SHARED 

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DECISION MAKING TOOLS.

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DR. LESLIE CURTIS IS CHAIR AND 

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PROFESSOR IN THE DEPARTMENT OF 

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POPULATION HEALTH SCIENCES AND 

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MEDICINE AT THE DUKE SCHOOL OF 

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MEDICINE.

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RHODE ISLAND SEARCHER DR. 

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CURTIS USES MEDICARE AND 

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MEDICAID OUTCOMES FOR RESOIP.

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SHE PLAYS A LEADING ROLE IN 

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NATIONAL EFFORTS TO IMPROVE 

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DATA QUALITY.

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DR. DARREN TOH IS A PROFESSOR 

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AT HARVARD MEDICAL SCHOOL AND 

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HARVARD PILGRIM HEALTH CARE 

255
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INSTITUTE.

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HE IS AN EPIDEMIOLOGIST, 

257
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DEVELOPING AND APPLYING 

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PRIVACY, TO CONDUCT 

259
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MULTI-CENTER STUDIES AND 

260
00:10:12,630 --> 00:10:13,598
DISTRIBUTE DATA NETWORKS.

261
00:10:13,598 --> 00:10:15,466
IT'S BEEN A PLEASURE TO WORK 

262
00:10:15,466 --> 00:10:17,135
WITH THESE THREE SCIENTISTS 

263
00:10:17,135 --> 00:10:18,136
PLANNING THIS WORKSHOP.

264
00:10:18,136 --> 00:10:20,805
NEXT WE WILL HEAR OPENING 

265
00:10:20,805 --> 00:10:23,141
REMARKS BY DR. ARTERBURN.

266
00:10:23,141 --> 00:10:25,810
>> David Arterburn: THANK
YOU, 

267
00:10:25,810 --> 00:10:31,349
DR. HALES, I'M AT KAISER 

268
00:10:31,349 --> 00:10:32,617
PERMANENTE SEATTLE.

269
00:10:32,617 --> 00:10:34,085
IT'S A GREAT OPPORTUNITY TO 

270
00:10:34,085 --> 00:10:34,886
ADDRESS YOU, I WANT TO THANK 

271
00:10:34,886 --> 00:10:37,422
YOU FOR THE WARM WELCOME, DR. 

272
00:10:37,422 --> 00:10:39,090
HALES AND ALSO, THANK YOU ON 

273
00:10:39,090 --> 00:10:42,593
BEHALF OF OUR CO-CHAIRS, DARREN 

274
00:10:42,593 --> 00:10:45,363
TOH FROM HARVARD PILGRIM, 

275
00:10:45,363 --> 00:10:47,465
HARVARD MEDICAL SCHOOL AND 

276
00:10:47,465 --> 00:10:49,767
LESLIE CURTIS FROM DUKE 

277
00:10:49,767 --> 00:10:50,068
UNIVERSITY.

278
00:10:50,068 --> 00:10:52,503
I ALSO WANT TO THANK DR. OS 

279
00:10:52,503 --> 00:10:55,406
GAINIAN AND YANOVSKI AND THE 

280
00:10:55,406 --> 00:10:56,441
WHOLE CO-CHAIR TEAM FOR THE 

281
00:10:56,441 --> 00:10:58,343
HARD WORK OVER THE PAST YEAR, 

282
00:10:58,343 --> 00:11:00,945
HELPING US DESIGN THIS VERY 

283
00:11:00,945 --> 00:11:02,714
ENGAGING PROGRAM, WHICH I THINK 

284
00:11:02,714 --> 00:11:04,749
WILL ENLIGHTEN ALL OF US AND 

285
00:11:04,749 --> 00:11:07,418
INSPIRE US TO TAKE THE NEXT 

286
00:11:07,418 --> 00:11:09,287
STEP IN EVALUATING THE 

287
00:11:09,287 --> 00:11:11,155
LONG-TERM AND REAL-WORLD 

288
00:11:11,155 --> 00:11:11,956
EFFECTIVENESS OF GLP-1 

289
00:11:11,956 --> 00:11:13,224
MEDICATIONS.

290
00:11:13,224 --> 00:11:15,693
I THINK THE GLP-1 MEDICATIONS 

291
00:11:15,693 --> 00:11:17,795
ARE CLEARLY USHERING IN A 

292
00:11:17,795 --> 00:11:19,197
PARADIGM SHIFT IN TREATMENT OF 

293
00:11:19,197 --> 00:11:22,100
MANY CHRONIC DISEASES.

294
00:11:22,100 --> 00:11:23,768
MOST NOTABLY OBESITY, WHICH HAS 

295
00:11:23,768 --> 00:11:26,871
A VERY DIFFICULT TIME 

296
00:11:26,871 --> 00:11:28,573
IDENTIFYING MEDICATIONS THAT 

297
00:11:28,573 --> 00:11:30,641
COULD INFLUENCE THE LONG-TERM 

298
00:11:30,641 --> 00:11:32,877
HEALTH AND PRA JECT RY OF 

299
00:11:32,877 --> 00:11:34,178
PATIENTS WITH THAT CHRONIC 

300
00:11:34,178 --> 00:11:34,946
DISEASE.

301
00:11:34,946 --> 00:11:38,449
BEFORE I DIVE INTO THE HISTORY 

302
00:11:38,449 --> 00:11:40,418
OF GLP-1'S AND IMPACT, AND 

303
00:11:40,418 --> 00:11:42,620
BEFORE WE GET INTO THE TOPICS 

304
00:11:42,620 --> 00:11:43,454
AND CONVERSATION TODAY, I 

305
00:11:43,454 --> 00:11:47,024
WANTED TO TAKE A LOOK BACK AT A 

306
00:11:47,024 --> 00:11:48,659
PRIOR NIH WORKSHOP AND IMPACT A 

307
00:11:48,659 --> 00:11:49,861
DAY LIKE TODAY AND TOMORROW 

308
00:11:49,861 --> 00:11:52,797
WILL HAVE ON THE FIELD AND IN 

309
00:11:52,797 --> 00:11:54,031
HELPING US MOVE THE NEEDLE 

310
00:11:54,031 --> 00:11:54,866
FORWARD.

311
00:11:54,866 --> 00:11:56,934
I HAD THE PLEASURE OF 

312
00:11:56,934 --> 00:11:59,437
CO-CHAIRING A WORKSHOP IN 2013 

313
00:11:59,437 --> 00:12:01,706
WITH ANITA KIRK LASS FROM 

314
00:12:01,706 --> 00:12:03,374
UNIVERSITY OF PITTSBURGH ON THE 

315
00:12:03,374 --> 00:12:11,182
LONG TERM OUTCOMES OF BARIATRIC 

316
00:12:11,182 --> 00:12:12,884
SURGERY.

317
00:12:12,884 --> 00:12:16,220
THIS LED TO AN ARTICLE IN JAMA 

318
00:12:16,220 --> 00:12:19,123
BUT HAD MANY OTHER IMPACTS 

319
00:12:19,123 --> 00:12:20,825
BEYOND THAT CONFERENCE.

320
00:12:20,825 --> 00:12:23,694
NEXT SLIDE, PLEASE, DR. HALES.

321
00:12:23,694 --> 00:12:25,530
ONE OF THE OUTCOMES OF THAT 

322
00:12:25,530 --> 00:12:28,199
MEETING WAS A SPECIFIC NIH 

323
00:12:28,199 --> 00:12:29,133
FUNDING ANNOUNCEMENT THAT 

324
00:12:29,133 --> 00:12:30,301
EMERGED.

325
00:12:30,301 --> 00:12:32,136
WE GATHERED TOGETHER TO TALK 

326
00:12:32,136 --> 00:12:35,072
ABOUT LONG-TERM OUTCOMES OF 

327
00:12:35,072 --> 00:12:37,875
BARIATRIC SURGERY AND THE GAPS 

328
00:12:37,875 --> 00:12:39,744
IN REAL-WORLD EVIDENCE, AS WELL 

329
00:12:39,744 --> 00:12:42,246
AS OTHER TYPES OF STUDIES THAT 

330
00:12:42,246 --> 00:12:43,481
COULD INFLUENCE OUR 

331
00:12:43,481 --> 00:12:45,550
UNDERSTANDING OF LONG-TERM 

332
00:12:45,550 --> 00:12:49,520
OUTCOMES AND NIDDK AND NIDA 

333
00:12:49,520 --> 00:12:51,622
ALSO RELEASED THIS FUNDING 

334
00:12:51,622 --> 00:12:55,326
ANNOUNCEMENT, WHICH LED TO 

335
00:12:55,326 --> 00:12:58,029
SEVERAL RO1 GRANTS EVALUATING 

336
00:12:58,029 --> 00:13:01,332
THE LONG-TERM EFFECTIVENESS OF 

337
00:13:01,332 --> 00:13:02,800
BARIATRIC SURGERY LOOKING AT 

338
00:13:02,800 --> 00:13:04,235
VARIOUS HEALTH OUTCOMES FROM 

339
00:13:04,235 --> 00:13:07,738
SUBSTANCE AND ALCOHOL ABUSE, 

340
00:13:07,738 --> 00:13:10,608
DEPRESSION, LONG-TERM IMPACTS 

341
00:13:10,608 --> 00:13:13,511
ON CARDIOVASCULAR DISEASES.

342
00:13:13,511 --> 00:13:14,946
SO NUMEROUS STUDIES CAME OUT 

343
00:13:14,946 --> 00:13:17,014
AND PAPERS THAT HAD A HIGH 

344
00:13:17,014 --> 00:13:18,783
IMPACT EVALUATING THE LONGER 

345
00:13:18,783 --> 00:13:21,586
TERM OUTCOMES OF BARIATRIC 

346
00:13:21,586 --> 00:13:22,687
SURGERY AS A RESULT OF THAT 

347
00:13:22,687 --> 00:13:23,788
WORKSHOP.

348
00:13:23,788 --> 00:13:25,823
AS WE ARE THINKING OF THE 

349
00:13:25,823 --> 00:13:27,525
POTENTIAL IMPACT OF TODAY, I 

350
00:13:27,525 --> 00:13:29,861
WANT TO ENCOURAGE OUR NIH 

351
00:13:29,861 --> 00:13:32,396
COLLEAGUES TO THINK ABOUT 

352
00:13:32,396 --> 00:13:34,265
WHETHER AN OUTCOME LIKE A 

353
00:13:34,265 --> 00:13:35,700
WORKSHOP LIKE THIS THAT COULD 

354
00:13:35,700 --> 00:13:38,836
HELP MOVE THE WORLD FORWARD OF 

355
00:13:38,836 --> 00:13:40,705
EVALUATING THE REAL-WORLD 

356
00:13:40,705 --> 00:13:41,506
EFFECTIVENESS OF GLP-1 

357
00:13:41,506 --> 00:13:43,207
MEDICATIONS.

358
00:13:43,207 --> 00:13:45,476
NEXT SLIDE, PLEASE.

359
00:13:45,476 --> 00:13:47,812
ANOTHER KEY OUTCOME OF THIS 

360
00:13:47,812 --> 00:13:51,115
WORKSHOP WAS THE FORMATION OF A 

361
00:13:51,115 --> 00:13:53,384
UNIQUE COLLABORATION CALLED THE 

362
00:13:53,384 --> 00:13:55,253
ALLIANCE OF RANDOMIZED TRIALS 

363
00:13:55,253 --> 00:13:58,389
OF MEDICINE VERSUS METABOLIC 

364
00:13:58,389 --> 00:14:05,029
SURGERY IN TYPE 2 DIABETES, THE 

365
00:14:05,029 --> 00:14:08,566
ARMMS-T2D CONSORTIUM.

366
00:14:08,566 --> 00:14:10,668
ENROLLING 262 PARTICIPANTS FROM 

367
00:14:10,668 --> 00:14:12,570
FOUR SEPARATE RANDOMIZED 

368
00:14:12,570 --> 00:14:16,240
CONTROL TRIALS *F BARIATRIC 

369
00:14:16,240 --> 00:14:18,142
SURGERY AGAINST OTHER 

370
00:14:18,142 --> 00:14:19,577
INTERVENTIONS FOR OBESITY AND 

371
00:14:19,577 --> 00:14:21,879
TYPE 2 DIABETES AND FOLLOWED UP 

372
00:14:21,879 --> 00:14:23,948
UP TO 12 YEARS AFTER 

373
00:14:23,948 --> 00:14:25,650
RANDOMIZATION.

374
00:14:25,650 --> 00:14:29,954
THEY EXTENDED THE LONG-TERM 

375
00:14:29,954 --> 00:14:33,658
FOLLOW-UP OF RANDOMIZED 

376
00:14:33,658 --> 00:14:35,359
LONG-TERM CLINICAL TRIALS, 

377
00:14:35,359 --> 00:14:36,394
INITIALLY SHORTER TERM 

378
00:14:36,394 --> 00:14:38,629
EVALUATIONS.

379
00:14:38,629 --> 00:14:40,898
INCLUDED CLEVELAND CLINIC, 

380
00:14:40,898 --> 00:14:42,567
JOSLYN DIABETES CENTER IN 

381
00:14:42,567 --> 00:14:44,101
BOSTON, UNIVERSITY OF 

382
00:14:44,101 --> 00:14:46,103
PITTSBURGH, UNIVERSITY OF 

383
00:14:46,103 --> 00:14:47,738
WASHINGTON, KAISER PERMANENTE 

384
00:14:47,738 --> 00:14:50,274
AND PENNINGTON BIOMEDICAL.

385
00:14:50,274 --> 00:14:53,611
THIS GRAPH SHOWS A 12-YEAR 

386
00:14:53,611 --> 00:14:55,880
FOLLOW-UP DATA ON LONG TERM 

387
00:14:55,880 --> 00:14:58,182
IMPACTS ON BODY WEIGHT IN THOSE 

388
00:14:58,182 --> 00:15:00,518
WHO RECEIVED METABOLIC SURGERY 

389
00:15:00,518 --> 00:15:02,787
AND THOSE WHO RECEIVED 

390
00:15:02,787 --> 00:15:03,487
INTENSIVE LIFESTYLE MEDICAL 

391
00:15:03,487 --> 00:15:05,690
THERAPY.

392
00:15:05,690 --> 00:15:07,558
IT EVALUATED LONG-TERM OUTCOMES 

393
00:15:07,558 --> 00:15:10,261
ON WEIGHT LOSS, GLYCEMIC 

394
00:15:10,261 --> 00:15:13,397
CONTROL, DIABETES REMISSION AND 

395
00:15:13,397 --> 00:15:17,368
RELAPSE, BLOOD PRESSURE, HDL 

396
00:15:17,368 --> 00:15:19,904
AND LDL CHOLESTEROL, TRY 

397
00:15:19,904 --> 00:15:21,205
GLYCERIDES, ADVERSE EVENTS 

398
00:15:21,205 --> 00:15:23,908
QUALITY OF LIFE AND SOCIAL 

399
00:15:23,908 --> 00:15:25,343
DETERMINANTS OF HEALTH.

400
00:15:25,343 --> 00:15:27,244
I THINK THIS REPRESENTS THE 

401
00:15:27,244 --> 00:15:30,948
KIND OF INNOVATIVE 

402
00:15:30,948 --> 00:15:31,682
OUT-OF-THE-BOX THINKING THAT 

403
00:15:31,682 --> 00:15:33,651
COULD EMERGE FROM A MEETING 

404
00:15:33,651 --> 00:15:34,919
LIKE TODAY, WHERE WE THINK WHAT 

405
00:15:34,919 --> 00:15:37,622
ARE THE POTENTIAL OPPORTUNITIES 

406
00:15:37,622 --> 00:15:41,525
TO HELP MOVE THIS FORWARD AND 

407
00:15:41,525 --> 00:15:42,994
TO UNDERSTAND LONG-TERM 

408
00:15:42,994 --> 00:15:46,564
OUTCOMES OF GLP-1 MEDICATIONS.

409
00:15:46,564 --> 00:15:48,866
NEXT SLIDE, PLEASE, CRAIG.

410
00:15:48,866 --> 00:15:50,434
ANOTHER WAY OF MEASURING IMPACT 

411
00:15:50,434 --> 00:15:52,770
IS TO TAKE A LOOK AT THE 

412
00:15:52,770 --> 00:15:54,605
PUBLICATIONS THAT EMERGED 

413
00:15:54,605 --> 00:15:55,906
FOLLOWING THAT CONFERENCE.

414
00:15:55,906 --> 00:15:58,342
AND SO I TOOK A LOOK AT PUBMED 

415
00:15:58,342 --> 00:16:05,850
AND DID A SEARCH ON BARIATRIC 

416
00:16:05,850 --> 00:16:06,717
AND OBSERVATIONAL STUDIES WHICH 

417
00:16:06,717 --> 00:16:09,987
WAS A KEY COMPONENT OF THE 

418
00:16:09,987 --> 00:16:12,256
STUDIES MANDATE WAS TO LOOK AT 

419
00:16:12,256 --> 00:16:14,125
REAL-WORLD AND OBSERVATIONAL 

420
00:16:14,125 --> 00:16:15,660
DATA AND ABILITY TO LOOK AT 

421
00:16:15,660 --> 00:16:19,463
THOSE STUDIES FOR IMPACTING 

422
00:16:19,463 --> 00:16:22,066
BARIATRIC SURGERY OUTCOMES.

423
00:16:22,066 --> 00:16:25,703
BARE

424
00:16:25,703 --> 00:16:27,405
SINCE THE INCEPTION OF PUBMED 

425
00:16:27,405 --> 00:16:31,008
THERE HAVE BEEN OVER 1800 

426
00:16:31,008 --> 00:16:34,111
PUBLICATIONS BUT 1600 OF THOSE, 

427
00:16:34,111 --> 00:16:38,049
OR 89% OCCURRED AFTER THIS 2013 

428
00:16:38,049 --> 00:16:38,416
WORKSHOP.

429
00:16:38,416 --> 00:16:40,718
AND SO THIS WAS BEGINNING, THIS 

430
00:16:40,718 --> 00:16:42,787
SORT OF WORKSHOP BEGAN AT THIS 

431
00:16:42,787 --> 00:16:45,089
SORT OF IMPORTANT JUNCTION, 

432
00:16:45,089 --> 00:16:46,957
JUST BEFORE THERE WAS THIS 

433
00:16:46,957 --> 00:16:48,225
REALLY LARGE AMOUNT OF WORK 

434
00:16:48,225 --> 00:16:51,128
BEING DONE TO HELP CLARIFY THE 

435
00:16:51,128 --> 00:16:53,931
LONG-TERM OUTCOMES OF BARIATRIC 

436
00:16:53,931 --> 00:16:57,301
SURGERY USING OBSERVATIONAL 

437
00:16:57,301 --> 00:17:04,375
STUDY DESIGNS.

438
00:17:04,375 --> 00:17:08,112
AGAIN, WE ARE ON THIS 

439
00:17:08,112 --> 00:17:10,081
PRECIPICE, NEXT SLIDE, PLEASE, 

440
00:17:10,081 --> 00:17:10,648
CRAIG.

441
00:17:10,648 --> 00:17:13,584
IF WE DO THE SAME SEARCH ON 

442
00:17:13,584 --> 00:17:15,653
GLP-1'S IN OBSERVATIONAL 

443
00:17:15,653 --> 00:17:17,288
STUDIES, WHAT YOU WILL SEE IS 

444
00:17:17,288 --> 00:17:19,557
THERE'S ALREADY, IN 2024 A HUGE 

445
00:17:19,557 --> 00:17:21,726
SPIKE IN THE NUMBER OF 

446
00:17:21,726 --> 00:17:24,729
OBSERVATIONAL STUDIES THAT HAVE 

447
00:17:24,729 --> 00:17:27,264
BEEN CONDUCTED, INVOLVING GLP-1 

448
00:17:27,264 --> 00:17:29,533
MIDCATIONS.

449
00:17:29,533 --> 00:17:30,668
MUCH LARGER THAN THERE WERE IN 

450
00:17:30,668 --> 00:17:31,602
2023.

451
00:17:31,602 --> 00:17:34,939
AND ALREADY, AS OF THIS MONTH, 

452
00:17:34,939 --> 00:17:36,707
IN 2025, WE HAVE ALREADY 

453
00:17:36,707 --> 00:17:39,210
PUBLISHED AS MANY ARTICLES, 

454
00:17:39,210 --> 00:17:42,113
OBSERVATIONAL STUDIES IN THIS 

455
00:17:42,113 --> 00:17:45,449
SPACE AS THERE WERE ALMOST IN 

456
00:17:45,449 --> 00:17:45,649
2023.

457
00:17:45,649 --> 00:17:48,119
ANOTHER KEY THING TO NOTE IS 

458
00:17:48,119 --> 00:17:50,387
THAT THERE'S ALREADY 751 

459
00:17:50,387 --> 00:17:52,823
RESULTS FOR OBSERVATIONAL 

460
00:17:52,823 --> 00:17:54,692
STUDIES, COMPARED TO 1800 OVER 

461
00:17:54,692 --> 00:18:02,133
THE WHOLE INCEPTION, THIS 

462
00:18:02,133 --> 00:18:09,974
LONGER TIMEFRAME FOR BARIATRIC 

463
00:18:09,974 --> 00:18:10,207
SURGERY.

464
00:18:10,207 --> 00:18:11,242
IT'S BEEN A BUSY YEAR.

465
00:18:11,242 --> 00:18:12,276
IT'S HARD TO KEEP UP.

466
00:18:12,276 --> 00:18:14,145
THERE ARE SO MANY STUDIES 

467
00:18:14,145 --> 00:18:16,046
COMING OUT IN THIS SPACE.

468
00:18:16,046 --> 00:18:18,182
IT'S REALLY INSPIRING, THIS 

469
00:18:18,182 --> 00:18:20,050
GROUP OF SCIENTISTS AT NIH TO 

470
00:18:20,050 --> 00:18:21,519
COME TOGETHER AND FORM THIS 

471
00:18:21,519 --> 00:18:22,987
WORKSHOP TO HELP ADVANCE THE 

472
00:18:22,987 --> 00:18:24,889
FIELD AND SET STANDARDS IN THE 

473
00:18:24,889 --> 00:18:26,724
FIELD AROUND WHAT ARE THE BEST 

474
00:18:26,724 --> 00:18:28,659
PRACTICES THAT WE CAN USE AS 

475
00:18:28,659 --> 00:18:29,960
SCIENTISTS TO MOVE THIS FIELD 

476
00:18:29,960 --> 00:18:31,328
FORWARD.

477
00:18:31,328 --> 00:18:34,231
BECAUSE AS WE WORK WITH 

478
00:18:34,231 --> 00:18:35,099
REAL-WORLD OBSERVATIONAL DATA, 

479
00:18:35,099 --> 00:18:38,402
AS WE HAVE CONDUCT PRAGMATIC 

480
00:18:38,402 --> 00:18:39,737
TRIALS,THERE ARE BEST PRACTICES 

481
00:18:39,737 --> 00:18:42,339
THAT WE CAN ALL ADOPT TO HELP 

482
00:18:42,339 --> 00:18:43,707
ENSURE THE HIGHEST RIGOR AND 

483
00:18:43,707 --> 00:18:45,543
QUALITY OF THE STUDIES THAT ARE 

484
00:18:45,543 --> 00:18:46,277
BEING GENERATED.

485
00:18:46,277 --> 00:18:48,512
SO IT'S NOT JUST ABOUT VOLUME, 

486
00:18:48,512 --> 00:18:50,815
IT'S REALLY ABOUT QUALITY OF 

487
00:18:50,815 --> 00:18:52,616
THE SCIENCE WE ARE GENERATING.

488
00:18:52,616 --> 00:18:54,151
THERE ARE SO MANY DATABASES 

489
00:18:54,151 --> 00:18:54,885
AVAILABLE.

490
00:18:54,885 --> 00:18:55,953
SO MANY OPPORTUNITIES FOR 

491
00:18:55,953 --> 00:18:57,388
PEOPLE TO ENGAGE IN SCIENCE 

492
00:18:57,388 --> 00:18:59,456
LIKE THIS, BUT WE REALLY NEED 

493
00:18:59,456 --> 00:19:01,091
RIGOR TO HELP MOVE THE FIELD 

494
00:19:01,091 --> 00:19:01,959
FORWARD.

495
00:19:01,959 --> 00:19:03,494
AND WE NEED TO ASK THE 

496
00:19:03,494 --> 00:19:06,297
QUESTION, WHAT ARE THE BEST 

497
00:19:06,297 --> 00:19:07,965
QUESTIONS THAT REAL-WORLD DATA 

498
00:19:07,965 --> 00:19:10,034
CAN ANSWER, OR WHAT ARE THE 

499
00:19:10,034 --> 00:19:12,136
CHALLENGES AND LIMITATIONS TO 

500
00:19:12,136 --> 00:19:13,470
ANSWERING THOSE QUESTIONS WITH 

501
00:19:13,470 --> 00:19:14,638
REAL-WORLD DATA.

502
00:19:14,638 --> 00:19:16,373
THAT'S WHAT THIS WORKSHOP IS 

503
00:19:16,373 --> 00:19:17,174
FOCUSED ON.

504
00:19:17,174 --> 00:19:18,342
I THINK AT THE END YOU WILL 

505
00:19:18,342 --> 00:19:20,845
HAVE A CLEAR PICTURE WHAT THE 

506
00:19:20,845 --> 00:19:22,112
MAJOR GAPS ARE, OPPORTUNITIES 

507
00:19:22,112 --> 00:19:23,581
FOR RESEARCH IN THIS SPACE.

508
00:19:23,581 --> 00:19:26,283
AND WE WILL HAVE A CLEARER 

509
00:19:26,283 --> 00:19:27,685
PICTURE OF NEXT STEPS WE CAN 

510
00:19:27,685 --> 00:19:29,253
ALL BEGIN TO TAKE.

511
00:19:29,253 --> 00:19:30,788
I WILL SAY THERE'S ALSO A LOT 

512
00:19:30,788 --> 00:19:33,657
OF RESEARCH ONGOING.

513
00:19:33,657 --> 00:19:38,262
NIH THERE ARE AT LEAST 15 

514
00:19:38,262 --> 00:19:40,364
DIFFERENT REAL-WORLD, OR 

515
00:19:40,364 --> 00:19:41,799
OBSERVATIONAL ORIENTED STUDIES 

516
00:19:41,799 --> 00:19:44,034
THAT ARE INVESTIGATING GLP-1'S 

517
00:19:44,034 --> 00:19:45,669
ACROSS A VARIETY OF HEALTH 

518
00:19:45,669 --> 00:19:46,337
CONDITIONS.

519
00:19:46,337 --> 00:19:48,606
THE WORK IS ALREADY GOING, IT 

520
00:19:48,606 --> 00:19:49,640
WILL BE CONTINUING.

521
00:19:49,640 --> 00:19:52,076
AND IT WILL BE QUITE A RIDE 

522
00:19:52,076 --> 00:19:53,711
OVER THE COMING DECADE.

523
00:19:53,711 --> 00:19:56,847
AND LOOKING BACK TOWARDS 

524
00:19:56,847 --> 00:19:59,083
BARIATRIC SURGERY TO SEE WHAT 

525
00:19:59,083 --> 00:20:00,050
HAPPENS WITH GLP-1'S AS WE MOVE 

526
00:20:00,050 --> 00:20:01,819
FORWARD.

527
00:20:01,819 --> 00:20:04,722
NEXT SLIDE, PLEASE, CRAIG.

528
00:20:04,722 --> 00:20:06,757
ONE THING I WANTED TO SAY, IN 

529
00:20:06,757 --> 00:20:08,192
CASE YOU'RE NOT AWARE OF THIS, 

530
00:20:08,192 --> 00:20:09,793
IF YOU ARE TRYING TO KEEP UP 

531
00:20:09,793 --> 00:20:11,028
WITH THIS SPACE, ONE THING I 

532
00:20:11,028 --> 00:20:13,130
FOUND TO BE VERY HELPFUL IS YOU 

533
00:20:13,130 --> 00:20:16,600
CAN GET DAILY UPDATES ON GLP-1 

534
00:20:16,600 --> 00:20:17,635
PUBLICATIONS THROUGH NCBI.

535
00:20:17,635 --> 00:20:21,138
IF YOU GO TO PUBMED AND ENTER 

536
00:20:21,138 --> 00:20:31,582
IN YOUR SEARCH TERMS, SAY 

537
00:20:34,285 --> 00:20:42,293
SEMIGLUTIDE OR TIRZAPIDE.

538
00:20:42,293 --> 00:20:44,094
THAT WILL TAKE YOU TO A SEARCH, 

539
00:20:44,094 --> 00:20:45,963
IF YOU DON'T ALREADY HAVE A 

540
00:20:45,963 --> 00:20:56,106
PROFILE.

541
00:21:16,026 --> 00:21:19,897
THERE'S FIVE-TEN RELATED 

542
00:21:19,897 --> 00:21:20,597
SEMAGLUTIDE OR 

543
00:21:20,597 --> 00:21:21,398
TIRZEPATIDE-RELATED STUDIES.

544
00:21:21,398 --> 00:21:23,033
OVER THE PAST YEAR THERE'S BEEN 

545
00:21:23,033 --> 00:21:25,970
AT LEAST ONE, IF NOT TWO 

546
00:21:25,970 --> 00:21:26,603
REAL-WORLD EVIDENCE STUDIES 

547
00:21:26,603 --> 00:21:29,673
THAT HAD BEEN GENERATED ALMOST 

548
00:21:29,673 --> 00:21:31,175
EVERY WEEK.

549
00:21:31,175 --> 00:21:32,476
THAT HAVE HAD A SIGNIFICANT 

550
00:21:32,476 --> 00:21:33,911
IMPACT.

551
00:21:33,911 --> 00:21:36,213
AND SO KEEPING ABREAST OF THE 

552
00:21:36,213 --> 00:21:37,781
FIELD WILL BE REALLY IMPORTANT 

553
00:21:37,781 --> 00:21:39,750
AS WE ALL MOVE FORWARD.

554
00:21:39,750 --> 00:21:42,019
NEXT SLIDE, PLEASE, CRAIG.

555
00:21:42,019 --> 00:21:44,088
SO ONE, TWO QUICK SLIDES I 

556
00:21:44,088 --> 00:21:46,123
WANTED TO ILLUSTRATE OF THIS, 

557
00:21:46,123 --> 00:21:49,059
THAT WERE RECENT EXAMPLES WAS 

558
00:21:49,059 --> 00:21:51,929
THIS PAPER BY KIM ET AL. 

559
00:21:51,929 --> 00:21:53,597
COLLEAGUES PUBLISHED JUST LAST 

560
00:21:53,597 --> 00:22:04,141
WEEK USING EPIC COSMOS DATASET, 

561
00:22:05,976 --> 00:22:10,881
AMONG 39,000 ILLABLE ADULTS, 

562
00:22:10,881 --> 00:22:14,618
887,000 RECEIVED PRESCRIPTIONS 

563
00:22:14,618 --> 00:22:17,121
FOR SEMAGLUTIDE OR TIRZEPATIDE 

564
00:22:17,121 --> 00:22:19,223
FOR OBESITY.

565
00:22:19,223 --> 00:22:20,924
REALLY FROM 2023-2024.

566
00:22:20,924 --> 00:22:22,292
BUT THERE'S MAJOR LIMITATIONS 

567
00:22:22,292 --> 00:22:23,961
TO DATA LIKE THIS, WHICH ARE 

568
00:22:23,961 --> 00:22:25,629
THE IMPORTANCE OF THIS 

569
00:22:25,629 --> 00:22:27,531
CONFERENCE TODAY TO THINK ABOUT 

570
00:22:27,531 --> 00:22:30,167
WHAT ARE LIMITATIONS TO VARIOUS 

571
00:22:30,167 --> 00:22:33,137
REAL-WORLD DATASETS.

572
00:22:33,137 --> 00:22:35,739
EPIC COSMOS ONLY HAS THEIR 

573
00:22:35,739 --> 00:22:36,673
PARTICIPATING ORGANIZATIONS.

574
00:22:36,673 --> 00:22:39,343
THEY HAVE NO ONLINE PHARMACIES 

575
00:22:39,343 --> 00:22:41,145
FOR PRESCRIPTIONS THEY WERE 

576
00:22:41,145 --> 00:22:42,679
TRACKING THERE.

577
00:22:42,679 --> 00:22:47,184
THEY WERE LOOKING AT ONLY 

578
00:22:47,184 --> 00:22:53,223
PRESCRIPTIONS AND  NOT 

579
00:22:53,223 --> 00:22:56,927
MEDICATION FILLS.

580
00:22:56,927 --> 00:22:58,796
AND BRANDED MEDICATIONS ONLY 

581
00:22:58,796 --> 00:23:01,098
NOT OFF-LABEL USE.

582
00:23:01,098 --> 00:23:04,201
NEXT SLIDE, PLEASE, CRAIG.

583
00:23:04,201 --> 00:23:06,703
ANOTHER INTERESTING STUDY OR 

584
00:23:06,703 --> 00:23:09,573
PAPER SUMMARY PUBLISHED BY 

585
00:23:09,573 --> 00:23:11,642
DANIEL DRUCKER LAST WEEK, WHICH 

586
00:23:11,642 --> 00:23:14,545
IS AN OVERVIEW OF GLP-1-BASED 

587
00:23:14,545 --> 00:23:15,712
THERAPIES FOR DIABETES, OBESITY 

588
00:23:15,712 --> 00:23:17,014
AND BEYOND.

589
00:23:17,014 --> 00:23:17,915
IT INCLUDED THIS FIGURE, WHICH 

590
00:23:17,915 --> 00:23:20,117
I THINK IS A GOOD TOUCH STONE 

591
00:23:20,117 --> 00:23:21,952
FOR THE BEGINNING OF THE 

592
00:23:21,952 --> 00:23:22,252
CONFERENCE.

593
00:23:22,252 --> 00:23:25,556
ON THE TOP BOX IT DESCRIBES ALL 

594
00:23:25,556 --> 00:23:27,391
THE GLP-1 ACTIONS THROUGHOUT 

595
00:23:27,391 --> 00:23:28,859
THE BODY.

596
00:23:28,859 --> 00:23:30,360
AND THEY ARE NUMEROUS.

597
00:23:30,360 --> 00:23:33,897
AND THE OTHER PIECE THEY 

598
00:23:33,897 --> 00:23:35,566
ESTABLISH INDICATIONS LIST 

599
00:23:35,566 --> 00:23:37,468
WHICH KEEPS GROWING.

600
00:23:37,468 --> 00:23:38,102
ON THE LEFT-HAND SIDE OF THIS 

601
00:23:38,102 --> 00:23:39,736
FIGURE.

602
00:23:39,736 --> 00:23:40,971
ON THE RIGHT-HAND SIDE OF THE 

603
00:23:40,971 --> 00:23:45,142
FIGURE IS THE LARGE LIST OF 

604
00:23:45,142 --> 00:23:47,244
INVESTIGATIONAL INDICATIONS OF 

605
00:23:47,244 --> 00:23:47,845
GLP-1'S.

606
00:23:47,845 --> 00:23:49,279
DR. RODGERS SPOKE OF THIS 

607
00:23:49,279 --> 00:23:50,347
EARLIER, BUT THERE'S SOME 

608
00:23:50,347 --> 00:23:52,015
CONDITIONS IN HERE I DIDN'T 

609
00:23:52,015 --> 00:23:54,685
KNOW WERE CURRENTLY BEING 

610
00:23:54,685 --> 00:23:59,056
STUDIED RELATED TO GLP-1, LIKE 

611
00:23:59,056 --> 00:24:00,324
PSORIATIC ARTHRITIS.

612
00:24:00,324 --> 00:24:02,693
THERE'S AN OPPORTUNITY FOR 

613
00:24:02,693 --> 00:24:03,427
MULTI-DISCIPLINARY RESEARCH IN 

614
00:24:03,427 --> 00:24:05,229
THIS FIELD TO HELP MOVE THE 

615
00:24:05,229 --> 00:24:06,163
NEEDLE FORWARD.

616
00:24:06,163 --> 00:24:07,698
NEXT SLIDE, PLEASE.

617
00:24:07,698 --> 00:24:11,101
AS WE MOVE AHEAD TOGETHER AS A 

618
00:24:11,101 --> 00:24:12,736
GROUP, WE ARE WANTING TO GET 

619
00:24:12,736 --> 00:24:14,605
FEEDBACK FROM YOU TO HELP US 

620
00:24:14,605 --> 00:24:17,341
COMPILE THE LIST OF THE MOST 

621
00:24:17,341 --> 00:24:18,542
IMPORTANT MAJOR GAPS AND 

622
00:24:18,542 --> 00:24:20,410
OPPORTUNITIES FOR MAJOR 

623
00:24:20,410 --> 00:24:23,013
RESEARCH IN GLP-1'S USING 

624
00:24:23,013 --> 00:24:23,547
REAL-WORLD DATA.

625
00:24:23,547 --> 00:24:26,617
I WOULD LIKE YOU TO BEGIN USING 

626
00:24:26,617 --> 00:24:27,618
OUR Q&A FEATURE.

627
00:24:27,618 --> 00:24:30,320
IF YOU FIND THE Q&A BUTTON
ON 

628
00:24:30,320 --> 00:24:33,957
THE TOP BAR, DEPENDING THE WAY 

629
00:24:33,957 --> 00:24:36,827
YOUR TEAMS IS LAID OUT, FIND 

630
00:24:36,827 --> 00:24:38,695
THE Q&A FEATURE AND BEGIN 

631
00:24:38,695 --> 00:24:39,930
PUTTING YOUR SUGGESTIONS IN THE 

632
00:24:39,930 --> 00:24:41,598
Q&A ABOUT WHAT YOU THINK ARE

633
00:24:41,598 --> 00:24:42,799
THE MAJOR GAPS AND 

634
00:24:42,799 --> 00:24:44,735
OPPORTUNITIES FOR FUTURE 

635
00:24:44,735 --> 00:24:46,170
RESEARCH ON GLP-1'S.

636
00:24:46,170 --> 00:24:47,838
AND THEN AS THOSE START 

637
00:24:47,838 --> 00:24:50,507
EMERGING FROM THIS 

638
00:24:50,507 --> 00:24:51,308
CONVERSATION, WE WOULD 

639
00:24:51,308 --> 00:24:53,310
ENCOURAGE YOU TO DO THAT OVER 

640
00:24:53,310 --> 00:24:54,745
THE COMING MINUTES, AS WE ARE 

641
00:24:54,745 --> 00:24:57,247
BEGINNING TO LAUNCH THE 

642
00:24:57,247 --> 00:24:58,715
CONFERENCE THIS MORNING.

643
00:24:58,715 --> 00:25:02,019
AS YOU SEE THOSE COME UP, YOU 

644
00:25:02,019 --> 00:25:03,487
CAN UPVOTE THOSE SUGGESTIONS 

645
00:25:03,487 --> 00:25:05,989
MADE BY OTHERS BY CLICKING ON 

646
00:25:05,989 --> 00:25:08,859
THE LIKE BUTTON OR ACTUALLY 

647
00:25:08,859 --> 00:25:10,294
THERE'S AN UPVOTE BUTTON WHICH 

648
00:25:10,294 --> 00:25:11,562
IS AN UP ARROW.

649
00:25:11,562 --> 00:25:16,567
IF CLICK ON THE UP-ARROW THAT 

650
00:25:16,567 --> 00:25:17,801
WILL PROVIDE FEEDBACK TO US 

651
00:25:17,801 --> 00:25:19,469
ABOUT WHAT ARE THE HIGHEST 

652
00:25:19,469 --> 00:25:20,971
PRIORITY GAPS AND OPPORTUNITIES 

653
00:25:20,971 --> 00:25:22,606
IN THE FIELD.

654
00:25:22,606 --> 00:25:24,875
AND SO, PLEASE BEGIN PUTTING IN 

655
00:25:24,875 --> 00:25:26,577
YOUR SUGGESTIONS FOR MAJOR GAPS 

656
00:25:26,577 --> 00:25:27,978
AN OPPORTUNITIES FOR RESEARCH.

657
00:25:27,978 --> 00:25:29,713
WE LOOK FORWARD TO PULLING 

658
00:25:29,713 --> 00:25:31,148
THOSE TOGETHER AND SHARING THEM 

659
00:25:31,148 --> 00:25:32,816
BACK WITH YOU AS THE CONFERENCE 

660
00:25:32,816 --> 00:25:34,284
GOES ON.

661
00:25:34,284 --> 00:25:36,553
AT THIS POINT IT'S MY GREAT 

662
00:25:36,553 --> 00:25:39,089
PLEASURE TO INTRODUCE OUR FIRST 

663
00:25:39,089 --> 00:25:40,958
MODERATOR FOR TODAY'S KEYNOTE 

664
00:25:40,958 --> 00:25:44,861
SESSIONS, THAT'S DR. KIMBERLY 

665
00:25:44,861 --> 00:25:46,730
NARAIN FROM UCLA.

666
00:25:46,730 --> 00:25:47,965
KIMBERLY, THANK YOU FOR YOUR 

667
00:25:47,965 --> 00:25:49,299
MODERATION TODAY AND I TURN IT 

668
00:25:49,299 --> 00:25:56,106
OVER TO YOU.

669
00:25:56,106 --> 00:26:00,077
>> KIMBERLY NARAIN: HELLO,
GOOD 

670
00:26:00,077 --> 00:26:01,945
MORNING, IT'S MY PLEASURE TO BE 

671
00:26:01,945 --> 00:26:03,714
HERE TO HAVE THE OPPORTUNITY TO 

672
00:26:03,714 --> 00:26:05,616
INTRODUCE OUR FIRST SPEAKER.

673
00:26:05,616 --> 00:26:14,157
DR. DAVID

674
00:26:14,157 --> 00:26:16,026
D'ALESSIO.

675
00:26:16,026 --> 00:26:19,396
HE IS A RESEARCHER AT DUKE 

676
00:26:19,396 --> 00:26:20,464
SCHOOL OF MEDICINE.

677
00:26:20,464 --> 00:26:24,167
HE HAS BEEN AT THE BEGINNING 

678
00:26:24,167 --> 00:26:25,435
CONDUCTING RESEARCH THAT HAS 

679
00:26:25,435 --> 00:26:26,703
ALLOWED US TO UNDERSTAND THE 

680
00:26:26,703 --> 00:26:28,572
WAY THAT THESE THERAPIES WORK 

681
00:26:28,572 --> 00:26:32,542
IN THE BRAIN.

682
00:26:32,542 --> 00:26:37,547
HE ALSO REALLY HAD A FRONT-ROW 

683
00:26:37,547 --> 00:26:39,416
SEAT AS THIS KNOWLEDGE HAS 

684
00:26:39,416 --> 00:26:40,017
REALLY TRANSLATED FROM THE 

685
00:26:40,017 --> 00:26:41,918
BENCH TO THE BEDSIDE.

686
00:26:41,918 --> 00:26:43,553
SO FROM THAT VANTAGE POINT HE 

687
00:26:43,553 --> 00:26:46,056
IS REALLY THE PERFECT PERSON TO 

688
00:26:46,056 --> 00:26:48,392
TALK TO US ABOUT THE WAY THESE 

689
00:26:48,392 --> 00:26:50,427
THERAPIES WORK AND TO GIVE US 

690
00:26:50,427 --> 00:26:52,362
SOME INSIGHT INTO WHAT WE CAN 

691
00:26:52,362 --> 00:26:53,664
EXPECT WITH THESE THERAPIES IN
THE FUTURE.

692
00:26:53,664 --> 00:26:54,379
TAKE IT AWAY DR. D'ALESSIO.

693
00:26:55,098 --> 00:27:05,575


694
00:26:56,122 --> 00:26:57,724
>> David D'Alessio: THERE,
CAN 

695
00:26:57,724 --> 00:26:58,358
PEOPLE HEAR ME NOW?

696
00:26:58,358 --> 00:26:59,158
>> YES.

697
00:26:59,158 --> 00:27:00,360
>> David D'Alessio: MY
SLIDES 

698
00:27:00,360 --> 00:27:00,860
ARE UP?

699
00:27:00,860 --> 00:27:02,528
>> YES.

700
00:27:02,528 --> 00:27:04,030
>> David D'Alessio: KIM,
THANK 

701
00:27:04,030 --> 00:27:06,065
YOU VERY MUCH, THAT WAS A KIND 

702
00:27:06,065 --> 00:27:07,533
INTRODUCTION.

703
00:27:07,533 --> 00:27:09,636
I WAS ASSUMING I WAS INVITED 

704
00:27:09,636 --> 00:27:11,938
HERE BECAUSE I'M OLD AND WAS A 

705
00:27:11,938 --> 00:27:13,072
FELLOW WHEN GLP-1 FIRST CAME 

706
00:27:13,072 --> 00:27:13,606
OUT.

707
00:27:13,606 --> 00:27:15,208
I HAVE BEEN AROUND FOR A LONG 

708
00:27:15,208 --> 00:27:18,778
TIME BUT IT'S ACTUALLY BEEN A 

709
00:27:18,778 --> 00:27:21,080
VERY INTERESTING TO BE PART OF 

710
00:27:21,080 --> 00:27:22,982
WHAT'S BEEN I THINK A REAL 

711
00:27:22,982 --> 00:27:24,784
REVOLUTION AND TREATMENT *F 

712
00:27:24,784 --> 00:27:25,918
METABOLIC DISEASE.

713
00:27:25,918 --> 00:27:27,754
SO WHAT I'M GOING TO DO IS GIVE 

714
00:27:27,754 --> 00:27:30,890
YOU A SORT OF BACKGROUND.

715
00:27:30,890 --> 00:27:32,525
THIS WILL BE REALLY A SIDELINE 

716
00:27:32,525 --> 00:27:34,160
TO THE MAJOR TOPICS OF THIS 

717
00:27:34,160 --> 00:27:34,827
WORKSHOP.

718
00:27:34,827 --> 00:27:36,663
BUT I WILL TALK ABOUT THE 

719
00:27:36,663 --> 00:27:43,036
HISTORY OF THE INCRETIN EFFECT, 

720
00:27:43,036 --> 00:27:44,871
WHERE THEY CAME FROM.

721
00:27:44,871 --> 00:27:46,739
AND THEN TALK ROUGHLY THROUGH 

722
00:27:46,739 --> 00:27:49,442
THE EVOLUTION OF THE DRUGS, 

723
00:27:49,442 --> 00:27:51,110
INTRODUCE THE CONCEPT OF 

724
00:27:51,110 --> 00:27:55,148
MULTI-RHODE ISLAND   --  

725
00:27:55,148 --> 00:27:56,716
RECEPTOR AGONISTS WHICH I THINK 

726
00:27:56,716 --> 00:27:57,917
WILL BE TIMELY GOING FORWARD 

727
00:27:57,917 --> 00:27:59,419
AND GIVE YOU A COUPLE OPINIONS 

728
00:27:59,419 --> 00:28:00,953
ON THE FUTURE.

729
00:28:00,953 --> 00:28:02,322
PEOPLE KNEW FOR A LONG TIME 

730
00:28:02,322 --> 00:28:05,191
THAT IF YOU INTRODUCED GLUCOSE 

731
00:28:05,191 --> 00:28:11,264
IN THE GUT, THE  BLOOD SUGAR 

732
00:28:11,264 --> 00:28:14,934
RESPONSE WAS DIFFERENT THAN IV.

733
00:28:14,934 --> 00:28:18,271
THE TERM INCRETIN WAS JOINED IN 

734
00:28:18,271 --> 00:28:22,141
19 29 BY A GENTLEMAN NAMED 

735
00:28:22,141 --> 00:28:23,476
LABAR.

736
00:28:23,476 --> 00:28:26,145
THEY COULD GIVE GUT EXTRACTS TO 

737
00:28:26,145 --> 00:28:29,082
DOGS IN LOWER BLOOD SUGAR, IT 

738
00:28:29,082 --> 00:28:31,551
WORKED BY STIMULATING INTERNAL 

739
00:28:31,551 --> 00:28:39,959
SECRETIONS OF THE PANCREAS, 

740
00:28:39,959 --> 00:28:48,901
WHICH WAS INCRETIN.

741
00:28:48,901 --> 00:28:52,805
IN THE 60'S WHEN THE ASSAY FOR 

742
00:28:52,805 --> 00:28:55,274
INSULIN BECAME AVAILABLE.

743
00:28:55,274 --> 00:28:59,178
IF YOU GAVE GLUCOSE, THE 

744
00:28:59,178 --> 00:29:00,780
INSULIN RESPONSE WAS HIGHER 

745
00:29:00,780 --> 00:29:04,150
WHEN THE GLUCOSE CAME FROM THE 

746
00:29:04,150 --> 00:29:04,684
GUT.

747
00:29:04,684 --> 00:29:08,554
THE ASSUMPTION WAS THE GUT WAS 

748
00:29:08,554 --> 00:29:11,057
MAKING PEPTIDES AND THE HUNT 

749
00:29:11,057 --> 00:29:13,159
WENT IMMEDIATELY TO TRY TO FIND 

750
00:29:13,159 --> 00:29:14,427
THESE PEPTIDES.

751
00:29:14,427 --> 00:29:16,429
BECAUSE THAT SEEMED LIKE AN 

752
00:29:16,429 --> 00:29:17,997
INTERESTING PHYSIOLOGY.

753
00:29:17,997 --> 00:29:20,767
IN 1970 BROWN AND PETERSSON AT 

754
00:29:20,767 --> 00:29:25,037
UNIVERSITY OF BRITISH COLUMBIA 

755
00:29:25,037 --> 00:29:26,706
EXTRACTED KILOGRAMS AND PASSED 

756
00:29:26,706 --> 00:29:28,141
IT THROUGH COLUMNS AND CAME UP 

757
00:29:28,141 --> 00:29:33,346
WITH A MOLECULE THAT WAS 

758
00:29:33,346 --> 00:29:34,180
INSULIN ATROPIC.

759
00:29:34,180 --> 00:29:43,456
GIP.

760
00:29:43,456 --> 00:29:46,993
A DECADE LATE HE WHEN IT WENT 

761
00:29:46,993 --> 00:29:53,633
TO CLONING, THE PROGLUCAGON 

762
00:29:53,633 --> 00:29:55,835
GENE WAS FOUND.

763
00:29:55,835 --> 00:29:58,738
DOWNSTREAM IT LOOKED LIKE TWO 

764
00:29:58,738 --> 00:30:01,107
NEW MOLECULES ALSO ENCODED IN 

765
00:30:01,107 --> 00:30:07,480
THAT PRO-HORMONE, THE FIRST WAS 

766
00:30:07,480 --> 00:30:09,515
LABELED GLUCAGON 1.

767
00:30:09,515 --> 00:30:11,751
THAT HAD INSULIN A TROPIC 

768
00:30:11,751 --> 00:30:13,786
PROPERTIES AND THAT WAS THE 

769
00:30:13,786 --> 00:30:15,588
SECOND INCRETIN.

770
00:30:15,588 --> 00:30:17,190
SINCE 1984 LOTS OF PEOPLE 

771
00:30:17,190 --> 00:30:20,126
LOOKED FOR OTHER INCRETINS BUT 

772
00:30:20,126 --> 00:30:22,161
IT'S STILL GL P&G IP.

773
00:30:22,161 --> 00:30:24,864
THEY ARE SECRETED WHEN 

774
00:30:24,864 --> 00:30:27,166
NUTRIENTS GO THROUGH THE GUT.

775
00:30:27,166 --> 00:30:29,469
GLUCOSE AND FAT BEING MORE 

776
00:30:29,469 --> 00:30:31,103
POTENT THAN PROTEIN.

777
00:30:31,103 --> 00:30:35,274
IF YOU INFUSE THESE TO HUMANS 

778
00:30:35,274 --> 00:30:37,143
DUR A GLUCOSE TOLERANCE TEST 

779
00:30:37,143 --> 00:30:38,945
YOU SEE GLUCOSE ALONE 

780
00:30:38,945 --> 00:30:39,812
STIMULATES INSULIN.

781
00:30:39,812 --> 00:30:41,514
IF YOU ADD G.

782
00:30:41,514 --> 00:30:44,784
I. P. YOU DOUBLE IT, IF YOU ADD 

783
00:30:44,784 --> 00:30:47,954
GLP-1 YOU QUADRUPLE IT.

784
00:30:47,954 --> 00:30:49,121
THIS WAS THE PAPER THAT 

785
00:30:49,121 --> 00:30:50,790
LAUNCHED A LOT OF RESEARCH INTO 

786
00:30:50,790 --> 00:30:52,024
GLP-1.

787
00:30:52,024 --> 00:30:53,860
THIS DEMONSTRATION THESE 

788
00:30:53,860 --> 00:30:55,495
INCRETINS COULD BE PURIFIED, 

789
00:30:55,495 --> 00:30:57,697
GIVEN TO HUMANS AND HAVE THESE 

790
00:30:57,697 --> 00:30:58,831
STRIKING RESPONSES.

791
00:30:58,831 --> 00:31:01,934
NOT ONLY ON INSULIN SECRETION 

792
00:31:01,934 --> 00:31:04,470
BUT TO LOWER GLUCOSE.

793
00:31:04,470 --> 00:31:08,641
SO BASED ON THIS, THIS IS THE 

794
00:31:08,641 --> 00:31:10,610
INCRETIN AXIS AS WE TEACH 

795
00:31:10,610 --> 00:31:11,744
MEDICAL STUDENTS.

796
00:31:11,744 --> 00:31:14,413
THAT WHEN A HUMAN BEING OR MOST 

797
00:31:14,413 --> 00:31:20,586
MAMMALS EAT, NUTRIENTS ARE 

798
00:31:20,586 --> 00:31:22,255
ABSORBED THROUGH ANEROCITES AND 

799
00:31:22,255 --> 00:31:24,891
INTRODUCED IN THE BLOOD.

800
00:31:24,891 --> 00:31:27,226
L-CELLS AND K-CELLS ARE 

801
00:31:27,226 --> 00:31:31,631
STIMULATED TO RELEASE GI P&G
LP.

802
00:31:31,631 --> 00:31:39,105
THEY INTERACT WITH RECEPTORS, 

803
00:31:39,105 --> 00:31:40,373
GIP AND GLP.

804
00:31:40,373 --> 00:31:49,282
WITH A HIGH DEGREE OF HEMOLOGY.

805
00:31:49,282 --> 00:31:52,218
BETA CELLS END UP STIMULATING 

806
00:31:52,218 --> 00:31:52,618
INSULIN SECRETION.

807
00:31:52,618 --> 00:31:54,921
A KEY COMPONENT OF THIS AND 

808
00:31:54,921 --> 00:31:58,858
WHAT DIFFERS FROM A LOT OF 

809
00:31:58,858 --> 00:32:00,993
SYNTHETIC DIABETES DRUGS IS 

810
00:32:00,993 --> 00:32:03,496
THEY ONLY STIMULATE INSULIN 

811
00:32:03,496 --> 00:32:06,432
SECRETION WHEN BLOOD SUGAR IS 

812
00:32:06,432 --> 00:32:06,699
ELEVATED.

813
00:32:06,699 --> 00:32:08,267
THAT WAS ONE OF THE APPEALING 

814
00:32:08,267 --> 00:32:16,142
FEET YOUS  FEATURES, THE RISK 

815
00:32:16,142 --> 00:32:19,478
OF HYPOGLYCEMIA VERY LOW.

816
00:32:19,478 --> 00:32:25,551
IN 1993 A COUPLE STUDIES CAME 

817
00:32:25,551 --> 00:32:27,787
OUT, DR. NAUCK, HE BROUGHT IN 

818
00:32:27,787 --> 00:32:30,723
PEOPLE WITH BLOOD SUGARS OF 220.

819
00:32:30,723 --> 00:32:34,794
ONE DAY HE GAVE THEM SALINE AND 

820
00:32:34,794 --> 00:32:37,897
ANOTHER DAY TURNED ON AN 

821
00:32:37,897 --> 00:32:41,233
INFUSION OF GLP-1.

822
00:32:41,233 --> 00:32:45,204
THE BLOOD SUGAR DODDLES IN 

823
00:32:45,204 --> 00:32:47,740
SALINE BUT NORMALIZED IN THE 

824
00:32:47,740 --> 00:32:48,975
DIABETIC PATIENTS.

825
00:32:48,975 --> 00:32:50,509
IT BROUGHT THEIR BLOOD SUGARS 

826
00:32:50,509 --> 00:32:52,612
DOWN TO AN AVERAGE OF ABOUT 95.

827
00:32:52,612 --> 00:32:56,215
PART OF THIS WAS STIMULATION OF 

828
00:32:56,215 --> 00:32:58,084
INSULIN SECRETION BUT PART MAY 

829
00:32:58,084 --> 00:33:00,019
HAVE BEEN SUPPRESSION OF 

830
00:33:00,019 --> 00:33:02,455
GLUCAGON.

831
00:33:02,455 --> 00:33:04,323
BUT NEVERTHELESS, THESE WERE 

832
00:33:04,323 --> 00:33:05,891
EYE-OPENING SORTS OF STUDIES.

833
00:33:05,891 --> 00:33:10,363
I THINK THIS IS WHERE THE 

834
00:33:10,363 --> 00:33:13,032
PHARMACOLOGIC IN INCRETIN 

835
00:33:13,032 --> 00:33:14,700
LAUNCHS.

836
00:33:14,700 --> 00:33:18,437
JOHN TURNER'S GROUP IN 1997 

837
00:33:18,437 --> 00:33:22,808
OBSERVED TYPE 2 DIABETICS WHO 

838
00:33:22,808 --> 00:33:25,745
WERE HYPER GLYCEMIC OVERNIGHT 

839
00:33:25,745 --> 00:33:26,946
AND INTOLERANCE WITH BREAKFAST 

840
00:33:26,946 --> 00:33:28,214
AND LUNCH.

841
00:33:28,214 --> 00:33:33,152
HOOKED THEM UP TO GLP-1, 

842
00:33:33,152 --> 00:33:34,220
NORMALIZED BLOOD SUGAR 

843
00:33:34,220 --> 00:33:34,820
OVERNIGHT.

844
00:33:34,820 --> 00:33:36,255
IT LOOKED LIKE IT SORT OF CURED 

845
00:33:36,255 --> 00:33:37,123
DIABETES.

846
00:33:37,123 --> 00:33:38,991
WHAT WAS INTERESTING IN THIS 

847
00:33:38,991 --> 00:33:42,762
STUDY, THEY REPEATED THE GLP 

848
00:33:42,762 --> 00:33:44,630
ARM AND NORMALIZED BLOOD SUGAR 

849
00:33:44,630 --> 00:33:44,897
OVERNIGHT.

850
00:33:44,897 --> 00:33:46,899
BUT THEN WHEN THEY TURNED OFF 

851
00:33:46,899 --> 00:33:48,567
THE INFUSION, EVERYTHING FELL 

852
00:33:48,567 --> 00:33:49,568
APART IN MINUTES.

853
00:33:49,568 --> 00:33:54,840
IT TURNS OUT NATIVE GLP-1 IS 

854
00:33:54,840 --> 00:33:56,475
RAPIDLY METABOLIZED IN THE 

855
00:33:56,475 --> 00:33:58,377
CIRCULATION, IT HAS A HALF-LIFE 

856
00:33:58,377 --> 00:34:00,479
OF A MINUTE OR MINUTE AND A 

857
00:34:00,479 --> 00:34:02,314
HALF, SO IT WASN'T GOING TO BE 

858
00:34:02,314 --> 00:34:04,850
THE DRUG IN ITS NATIVE FORM.

859
00:34:04,850 --> 00:34:09,221
BUT THE TARGET WAS THERE, THE 

860
00:34:09,221 --> 00:34:10,823
GLP RECEPTOR LOOKED LIKE A 

861
00:34:10,823 --> 00:34:13,359
GREAT TARGET AND A LOT OF 

862
00:34:13,359 --> 00:34:13,993
PEOPLE STARTED CHASING THAT 

863
00:34:13,993 --> 00:34:14,994
RIGHT AWAY.

864
00:34:14,994 --> 00:34:18,297
HERE IS THE TIMELINE, INCRETINS 

865
00:34:18,297 --> 00:34:26,439
DISCOVERED IN 1985.

866
00:34:26,439 --> 00:34:27,339
EXENATIZE, REPTILIAN, CHEMISTS 

867
00:34:27,339 --> 00:34:30,009
LIKE TO LOOK AT SNAKE AND 

868
00:34:30,009 --> 00:34:34,180
REPTILE VENOM BECAUSE THEY ARE 

869
00:34:34,180 --> 00:34:37,516
FULL OF PEPTIDES.

870
00:34:37,516 --> 00:34:42,254
ONE AGONIST, ONLY PARTIALLY 

871
00:34:42,254 --> 00:34:44,123
HOMOLOGOUS.

872
00:34:44,123 --> 00:34:47,259
YOU COULD MODIFY THIS PEPTIDE 

873
00:34:47,259 --> 00:34:50,429
INTO AN ANTAGONIST AND THAT 

874
00:34:50,429 --> 00:34:51,597
HELPED RESEARCH.

875
00:34:51,597 --> 00:34:56,635
YOU START HAVING FDA-APPROVED 

876
00:34:56,635 --> 00:34:58,938
DRUGS, A THE FIRST DRUG ON THE 

877
00:34:58,938 --> 00:34:59,839
MARKET.

878
00:34:59,839 --> 00:35:01,674
COULD SEE A STUDY STREAM OF 

879
00:35:01,674 --> 00:35:05,077
DRUG DEVELOPMENT IN THIS SPACE 

880
00:35:05,077 --> 00:35:06,812
STARTING IN 2005.

881
00:35:06,812 --> 00:35:10,049
BECAUSE GLP IS A PEPTIDE AND 

882
00:35:10,049 --> 00:35:11,917
ITS RECEPTOR IS ACCESSIBLE TO 

883
00:35:11,917 --> 00:35:15,187
THAT STRUCTURE OF MOLECULE, ALL 

884
00:35:15,187 --> 00:35:17,790
THE EARLY DRUGS WERE 

885
00:35:17,790 --> 00:35:19,358
PEPTIDE-BASED.

886
00:35:19,358 --> 00:35:21,827
THAT IS MAKING PEOPLE WANTED TO 

887
00:35:21,827 --> 00:35:23,028
MAKE SMALL MOLECULES COULDN'T 

888
00:35:23,028 --> 00:35:25,998
FIGURE OUT HOW TO DO IT.

889
00:35:25,998 --> 00:35:27,500
SO PEPTIDE-BASED DRUGS NEED TO 

890
00:35:27,500 --> 00:35:28,267
BE INJECTED.

891
00:35:28,267 --> 00:35:31,036
THAT'S BEEN THE MODE OF GLP 

892
00:35:31,036 --> 00:35:32,438
THERAPY EVER SINCE.

893
00:35:32,438 --> 00:35:35,975
THEY ARE INSULIN A TROPIC, 

894
00:35:35,975 --> 00:35:38,077
GLUCOSE DEPENDENT, THEY DON'T 

895
00:35:38,077 --> 00:35:38,911
STIMULATE INSULIN WHEN THE 

896
00:35:38,911 --> 00:35:40,813
BLOOD SUGAR IS NORMAL OR LOW 

897
00:35:40,813 --> 00:35:43,616
AND HAVE A WELL KNOWN SIDE 

898
00:35:43,616 --> 00:35:45,417
EFFECT PROFILE.

899
00:35:45,417 --> 00:35:47,319
WHEN WE INFUSE GLP-1 IN 

900
00:35:47,319 --> 00:35:48,854
RESEARCH STUDIES WE CAN FIND A 

901
00:35:48,854 --> 00:35:50,156
CEILING TO THE EFFECT THE 

902
00:35:50,156 --> 00:35:51,924
PATIENT STARTS TO SAY ALL 

903
00:35:51,924 --> 00:35:55,227
RIGHT, I'M GETTING QUEASY, YOU 

904
00:35:55,227 --> 00:35:55,528
BETTER STOP.

905
00:35:55,528 --> 00:35:56,896
THAT TRANSLATED TO THE DRUGS.

906
00:35:56,896 --> 00:36:00,032
WHAT WE SAW WITH NATIVE GLP-1 

907
00:36:00,032 --> 00:36:02,968
TRANSLATED TO THE SYNTHETIC 

908
00:36:02,968 --> 00:36:08,808
GLP, FARM CO THERAPEUTICS AND 

909
00:36:08,808 --> 00:36:11,544
SIDE EFFECTS, NAUSEA, VOMITING, 

910
00:36:11,544 --> 00:36:13,612
DIARRHEA WERE THE KNOWN AND 

911
00:36:13,612 --> 00:36:15,080
ACCEPTED SIDE EFFECTS.

912
00:36:15,080 --> 00:36:17,416
A TOLERANCE TENDS TO OCCUR OVER 

913
00:36:17,416 --> 00:36:20,953
TIME AND THEY ARE BETTER 

914
00:36:20,953 --> 00:36:21,220
TOLERATED.

915
00:36:21,220 --> 00:36:23,022
CAN TITRATE AND BETTER MITIGATE 

916
00:36:23,022 --> 00:36:26,525
THE SIDE EFFECTS.

917
00:36:26,525 --> 00:36:30,129
THERE'S TWO GENERATIONS.

918
00:36:30,129 --> 00:36:40,673
THE FIRST WERE DAILY INJECTIONS,

919
00:36:41,440 --> 00:36:45,578
 BYETTA THEN VICTOZA.

920
00:36:45,578 --> 00:36:53,552
THEN WE GET TO TERZ TIED.

921
00:36:53,552 --> 00:36:57,323
THE FIRST STIMULATION OF 

922
00:36:57,323 --> 00:36:59,525
GLUCOSE STIMULATED INSULIN 

923
00:36:59,525 --> 00:37:01,060
SECRETION.

924
00:37:01,060 --> 00:37:02,761
ONCE PEOPLE STARTED DOING 

925
00:37:02,761 --> 00:37:04,730
CLINICAL TRIALS THEY NOTICED 

926
00:37:04,730 --> 00:37:06,365
OBSERVATIONS IN HUMANS 

927
00:37:06,365 --> 00:37:08,634
PARALLELED WHAT WE SAW IN RATS 

928
00:37:08,634 --> 00:37:08,901
AND MICE.

929
00:37:08,901 --> 00:37:10,502
THESE DRUGS MADE YOU EAT LESS 

930
00:37:10,502 --> 00:37:12,371
AND THERE WAS SOME WEIGHT LOSS.

931
00:37:12,371 --> 00:37:15,307
WITH THE FIRST DRUGS WE HAD A 

932
00:37:15,307 --> 00:37:17,409
REDUCTION OF A1C OF ABOUT 1% 

933
00:37:17,409 --> 00:37:21,780
WHICH WAS GOOD, STANDARD FAIR 

934
00:37:21,780 --> 00:37:23,582
FOR THE EARLY DECADE, THAT'S 

935
00:37:23,582 --> 00:37:26,085
WHAT YOU EXPECTED FROM A 

936
00:37:26,085 --> 00:37:28,587
DIABETES DRUG AND PEOPLE WOULD 

937
00:37:28,587 --> 00:37:30,556
LOSE 2-4 KILOGRAMS OF BODY 

938
00:37:30,556 --> 00:37:30,789
WEIGHT.

939
00:37:30,789 --> 00:37:32,391
THAT DOESN'T SOUND LIKE A LOT, 

940
00:37:32,391 --> 00:37:36,095
BUT THOSE DAYS WHEN WE HAD 

941
00:37:36,095 --> 00:37:38,397
THOSE TREATMENTS AND ALL THOSE 

942
00:37:38,397 --> 00:37:40,466
DRUGS LOWERED BLOOD SUGAR AND 

943
00:37:40,466 --> 00:37:42,935
CAUSED WEIGHT GAIN, TO TELL 

944
00:37:42,935 --> 00:37:44,803
SOMEBODY YOU WEREN'T GOING TO 

945
00:37:44,803 --> 00:37:46,639
GAIN WEIGHT AND MAYBE LOSE A 

946
00:37:46,639 --> 00:37:47,907
LITTLE WEIGHT WAS QUITE 

947
00:37:47,907 --> 00:37:49,942
APPEALING IN THE CLINIC.

948
00:37:49,942 --> 00:37:54,246
SO AGAIN, THIS NOTION THAT 

949
00:37:54,246 --> 00:37:56,315
GLP-1 SUPPRESSES FOOD INTAKE 

950
00:37:56,315 --> 00:37:58,584
CAUSED US TO RETHINK THE WHOLE 

951
00:37:58,584 --> 00:37:59,852
PHYSIOLOGY.

952
00:37:59,852 --> 00:38:01,954
THE RECEPTOR HAD BEEN CLONED 

953
00:38:01,954 --> 00:38:05,257
FROM BETA CELLS AND WE GOT INTO 

954
00:38:05,257 --> 00:38:06,725
GLP-1 PHYSIOLOGY IN 

955
00:38:06,725 --> 00:38:08,694
THERAPEUTICS AS A WAY TO 

956
00:38:08,694 --> 00:38:10,296
STIMULATE INSULIN SECRETION.

957
00:38:10,296 --> 00:38:13,032
BUT ONCE IT WAS APPARENT RATS 

958
00:38:13,032 --> 00:38:15,100
AND HERE HUMANS GIVEN GREATER 

959
00:38:15,100 --> 00:38:17,169
DOSES OF GLP-1 WILL DECREASE 

960
00:38:17,169 --> 00:38:19,505
CONSUMPTION OF A STANDARDIZED 

961
00:38:19,505 --> 00:38:20,940
MEAL, THEN PEOPLE STARTED TO 

962
00:38:20,940 --> 00:38:22,808
LOOK FOR BIOLOGY IN THE BRAIN.

963
00:38:22,808 --> 00:38:24,710
THAT'S WHERE FOOD INTAKE AND 

964
00:38:24,710 --> 00:38:27,012
ENERGY BALANCE IS CONTROLLED.

965
00:38:27,012 --> 00:38:31,951
TURNS OUT THE GLP-1 RECEPTOR IS 

966
00:38:31,951 --> 00:38:37,156
EXPRESSED IN THE HIND BRAIN AND 

967
00:38:37,156 --> 00:38:38,724
HYPOTHALAMUS.

968
00:38:38,724 --> 00:38:44,330
BEING IMPORTANT, THE AREA THERE 

969
00:38:44,330 --> 00:38:45,698
POSTDREMA OUTSIDE THE 

970
00:38:45,698 --> 00:38:46,665
BLOOD-BRAIN BARRIER.

971
00:38:46,665 --> 00:38:49,768
ONE OF THE PLACES IN THE BRAIN, 

972
00:38:49,768 --> 00:38:51,603
HYPOTHALAMUS BEING THE OTHER, 

973
00:38:51,603 --> 00:38:52,905
WHERE CIRCULATING MOLECULES, 

974
00:38:52,905 --> 00:38:56,008
WHETHER THEY BE ENDOGENOUS LIKE 

975
00:38:56,008 --> 00:39:03,716
GLP-1 OR EX OJ JUS HAVE ACCESS 

976
00:39:03,716 --> 00:39:04,016
TO NEURONS.

977
00:39:04,016 --> 00:39:05,985
THINGS THAT ENTER CIRCULATION 

978
00:39:05,985 --> 00:39:07,486
CAN ACTUALLY INFLUENCE CNS 

979
00:39:07,486 --> 00:39:08,087
FUNCTION.

980
00:39:08,087 --> 00:39:15,761
AND THAT'S WHERE THE SATIETY 

981
00:39:15,761 --> 00:39:19,465
WEIGHT LOSS AND NAUSEA WEIGHT 

982
00:39:19,465 --> 00:39:21,967
LOSS EFFECTS PLAY OUT.

983
00:39:21,967 --> 00:39:26,939
MANY DIFFERENT FLAVORS OF  

984
00:39:26,939 --> 00:39:29,375
GLP-1 LIKE I SAID, EITHER FROM 

985
00:39:29,375 --> 00:39:39,818
THE REPTILE DESCENDANT OR.

986
00:39:40,753 --> 00:39:45,724
LIXISENATIDE, EXENATIDE.

987
00:39:45,724 --> 00:39:51,764
THEN CAME LIRAGLUTIDE AND 

988
00:39:51,764 --> 00:39:53,365
SEMAGLUTIDE.

989
00:39:53,365 --> 00:39:55,367
THESE ARE SIMILAR TO NATIVE 

990
00:39:55,367 --> 00:39:59,038
GLP-1 BUT THEY AREN'T 

991
00:39:59,038 --> 00:40:00,239
METABOLIZED AND ACTIVATED IN 

992
00:40:00,239 --> 00:40:05,644
THE CIRCULATION AS MUCH.

993
00:40:05,644 --> 00:40:11,417
THESE DRUGS LIXI AND EXENATIDE 

994
00:40:11,417 --> 00:40:16,889
ARE PRETTY MUCH OB SOLETE THOSE 

995
00:40:16,889 --> 00:40:21,226
THAT HAVE LOUSY INSURANCE, AND 

996
00:40:21,226 --> 00:40:24,830
FORMULARY INSIST YOU USE THESE 

997
00:40:24,830 --> 00:40:28,000
FIRST.

998
00:40:28,000 --> 00:40:29,468
THESE TWO ARE THE PLAYERS RIGHT 

999
00:40:29,468 --> 00:40:33,639
NOW.

1000
00:40:33,639 --> 00:40:42,681
LIRAGLUTIDE AND DULAGLUTIDE 

1001
00:40:42,681 --> 00:40:44,983
DON'T LOWER ENOUGH.

1002
00:40:44,983 --> 00:40:46,385
IF PATIENTS HAVE ACCESS TO 

1003
00:40:46,385 --> 00:40:48,887
THIS, THIS IS WHAT YOU GO TO 

1004
00:40:48,887 --> 00:40:50,289
NOW.

1005
00:40:50,289 --> 00:40:51,557
SEMAGLUTIDE HAD COMPARATIVE 

1006
00:40:51,557 --> 00:40:55,527
EFFICACY WAY BEYOND WHAT YOU 

1007
00:40:55,527 --> 00:41:01,934
SAW WITH DULA OR LIRAGLUTIDE.

1008
00:41:01,934 --> 00:41:03,602
AND THE A1C'S DROPPED 2%.

1009
00:41:03,602 --> 00:41:05,637
IF YOU WOULD HAVE TOLD ME IN 

1010
00:41:05,637 --> 00:41:16,148
2010 THERE'S A SINGLE DRUG THAT 

1011
00:41:16,148 --> 00:41:20,119
WOULD DROP A1C 2% I WOULD HAVE 

1012
00:41:20,119 --> 00:41:23,021
SAID PIGS COULD FLY.

1013
00:41:23,021 --> 00:41:25,124
USING SEMAGLUTIDE AT THE 

1014
00:41:25,124 --> 00:41:27,226
HIGHEST DOSES CAUSED 

1015
00:41:27,226 --> 00:41:28,927
UNPRECEDENTED AMOUNTS OF WEIGHT 

1016
00:41:28,927 --> 00:41:31,797
LOSS, WHEREAS THE FIRST 

1017
00:41:31,797 --> 00:41:34,600
GENERATION GLP-1'S GAVE YOU 2-4 

1018
00:41:34,600 --> 00:41:35,567
KILOGRAMS THESE DRUGS STARTED 

1019
00:41:35,567 --> 00:41:38,036
TO GIVE YOU 10, 15, EVEN MORE 

1020
00:41:38,036 --> 00:41:40,772
BODY WEIGHT THAN THAT, WITH 

1021
00:41:40,772 --> 00:41:42,441
AVERAGE PERCENTAGES IN SOME OF 

1022
00:41:42,441 --> 00:41:44,209
THESE CLINICAL TRIALS OF OVER 

1023
00:41:44,209 --> 00:41:46,578
15%.

1024
00:41:46,578 --> 00:41:49,948
NOW 15% ISN'T WHAT YOU GET WITH 

1025
00:41:49,948 --> 00:41:51,517
A GASTRIC BYPASS, I USUALLY 

1026
00:41:51,517 --> 00:41:52,651
THINK THAT'S 30%.

1027
00:41:52,651 --> 00:41:55,487
BUT IT WAS COMPARABLE TO WHAT 

1028
00:41:55,487 --> 00:41:57,122
YOU SAW WITH GASTRIC BANDING.

1029
00:41:57,122 --> 00:42:01,894
AGAIN IN THE EARLY PART OF THE 

1030
00:42:01,894 --> 00:42:03,262
CENTURY STILL IN VOGUE.

1031
00:42:03,262 --> 00:42:04,663
THIS WAS WAY MORE THAN WHAT WE 

1032
00:42:04,663 --> 00:42:06,298
HAD ON THE MARKET FOR WEIGHT 

1033
00:42:06,298 --> 00:42:06,965
LOSS.

1034
00:42:06,965 --> 00:42:10,836
I THINK THAT'S WHERE IN THE 

1035
00:42:10,836 --> 00:42:14,173
CLINIC THINGS CHANGED AND 

1036
00:42:14,173 --> 00:42:15,774
PATIENTS STARTED COMING IN WITH 

1037
00:42:15,774 --> 00:42:17,009
INTERNET FOLDERS OF DATA ON 

1038
00:42:17,009 --> 00:42:19,511
THIS NEW DRUG.

1039
00:42:19,511 --> 00:42:23,649
AND ASKED FOR OZEMPIC BY NAME 

1040
00:42:23,649 --> 00:42:26,418
AND STARTED BEING BESIEGED BY 

1041
00:42:26,418 --> 00:42:28,487
ALL THE COMMERCIALS AND LOUSY 

1042
00:42:28,487 --> 00:42:30,155
JINGLES AND ALL THAT STUFF.

1043
00:42:30,155 --> 00:42:32,991
THAT'S WHERE IT MOVES FROM A 

1044
00:42:32,991 --> 00:42:36,495
DRUG FOR ENDO CINOLOGISTS TO A 

1045
00:42:36,495 --> 00:42:38,363
DRUG THAT ALL THE POPULATION IS 

1046
00:42:38,363 --> 00:42:40,799
ENTRANCED WITH.

1047
00:42:40,799 --> 00:42:42,901
SEMAGLUTIDE, I WOULD SAY IS THE 

1048
00:42:42,901 --> 00:42:47,873
A POJ YOE SIS OF GLP RECEPTOR 

1049
00:42:47,873 --> 00:42:49,074
AGONIST.

1050
00:42:49,074 --> 00:42:50,943
THE MOST POTENT, THE ONE IN 

1051
00:42:50,943 --> 00:42:53,011
MOST USE, THE ONE WHERE WE HAVE 

1052
00:42:53,011 --> 00:42:54,046
THE MOST DATA.

1053
00:42:54,046 --> 00:42:55,747
BUT OF COURSE, PEOPLE ALWAYS 

1054
00:42:55,747 --> 00:42:57,416
SAY, ONCE THE BAR IS SET, YOU 

1055
00:42:57,416 --> 00:42:59,685
WANT TO GO OVER THE BAR.

1056
00:42:59,685 --> 00:43:00,886
SO PEOPLE STARTED TALKING 

1057
00:43:00,886 --> 00:43:03,956
ABOUT, CAN WE MAKE BETTER 

1058
00:43:03,956 --> 00:43:04,656
INCRETIN-BASED DRUGS?

1059
00:43:04,656 --> 00:43:07,793
CAN WE MAKE THINGS MORE POTENT 

1060
00:43:07,793 --> 00:43:09,228
THAN SEMAGLUTIDE?

1061
00:43:09,228 --> 00:43:11,563
AND THE CONCEPT OF 

1062
00:43:11,563 --> 00:43:13,031
MULTI-RECEPTOR AGONIST WAS SORT 

1063
00:43:13,031 --> 00:43:16,368
OF STUMBLED UPON BY 

1064
00:43:16,368 --> 00:43:18,804
SERENDIPITY, A CHEMIST NAMED 

1065
00:43:18,804 --> 00:43:22,374
RICHARD DEMARKY WAS TRYING TO 

1066
00:43:22,374 --> 00:43:25,677
MAKE A SOLID GLUE CON, HE WAS 

1067
00:43:25,677 --> 00:43:28,146
FLIPPING TO TRY TO GET IT TO BE 

1068
00:43:28,146 --> 00:43:31,717
A BETTER DRUG FOR HYPOGLYCEMIA 

1069
00:43:31,717 --> 00:43:34,786
AND LO AND BEHOLD HE FOUND IT 

1070
00:43:34,786 --> 00:43:38,257
NOT ONLY ACTIVATED THE GLUCAGON 

1071
00:43:38,257 --> 00:43:40,158
BUT GLP-1 RECEPTOR.

1072
00:43:40,158 --> 00:43:42,594
WHAT WE TEACH EVERYBODY IS A 

1073
00:43:42,594 --> 00:43:45,264
PEPTIDE IS VERY SPECIFIC TO A 

1074
00:43:45,264 --> 00:43:51,470
TYPE OF RECEPTOR, GLP WITH THE 

1075
00:43:51,470 --> 00:43:54,206
GLP AND GIP WITH ONLY THE GIP.

1076
00:43:54,206 --> 00:43:59,544
BUT TURNS OUT YOU CAN BIND A 

1077
00:43:59,544 --> 00:44:01,947
MOLECULE WITH MULTI-RECEPTOR 

1078
00:44:01,947 --> 00:44:02,481
AGONISTS.

1079
00:44:02,481 --> 00:44:04,783
THOUGH WE DON'T KNOW EXACTLY 

1080
00:44:04,783 --> 00:44:06,785
THE PHARMACOLOGY HOW THEY WORK, 

1081
00:44:06,785 --> 00:44:09,054
YOU CAN SHOW THEY WILL HIT MORE 

1082
00:44:09,054 --> 00:44:10,455
THAN ONE RECEPTOR SIGNALING 

1083
00:44:10,455 --> 00:44:11,390
SYSTEM.

1084
00:44:11,390 --> 00:44:14,126
AND YOU MAKE A MULTI-RECEPTOR 

1085
00:44:14,126 --> 00:44:17,896
AGONIST BY WHAT'S CALLED 

1086
00:44:17,896 --> 00:44:19,164
ITERATIVE CHEMICAL REFINEMENT, 

1087
00:44:19,164 --> 00:44:22,134
OR BLACK BOX, TRIAL-AND-ERROR.

1088
00:44:22,134 --> 00:44:27,906
IN THE CASE OF TIRZEPATIDE, FOR 

1089
00:44:27,906 --> 00:44:29,808
GIP, YOU KNOW YOU WANT TO GET 

1090
00:44:29,808 --> 00:44:36,982
SOME ACTIVITY AT THE  GLP.

1091
00:44:36,982 --> 00:44:40,085
YOU GET A SINGLE PEPTIDE YOU 

1092
00:44:40,085 --> 00:44:43,021
CAN SHOW HAS A DOSE-DEPENDENT 

1093
00:44:43,021 --> 00:44:44,823
EFFECT IN MICE TO LOWER GLAOD 

1094
00:44:44,823 --> 00:44:47,159
SUGAR.

1095
00:44:47,159 --> 00:44:47,726
BLOOD SUGAR.

1096
00:44:47,726 --> 00:44:52,331
IT WILL WORK IN MICE THAT HAVE 

1097
00:44:52,331 --> 00:44:54,232
THE RECEPTOR KNOCKED OUT AND 

1098
00:44:54,232 --> 00:44:58,737
RESPOND TO DUAL AGONIST AND GIP.

1099
00:44:58,737 --> 00:45:02,741
THOSE THAT DOESN'T HAVE A GLP.

1100
00:45:02,741 --> 00:45:04,976
IT LOOKS LIKE THIS COMPOUND 

1101
00:45:04,976 --> 00:45:07,045
ACTUALLY WORKS THROUGH BOTH 

1102
00:45:07,045 --> 00:45:07,312
RECEPTORS.

1103
00:45:07,312 --> 00:45:09,348
THIS IS A STUDY MY COLLEAGUES 

1104
00:45:09,348 --> 00:45:19,891
AT DUKE DID WITH HUMAN EYELETS.

1105
00:45:20,592 --> 00:45:31,036
THEY WOULD GIVE AND LAYER ON 

1106
00:45:37,309 --> 00:45:38,710
TERZ TIED.

1107
00:45:38,710 --> 00:45:44,116
THEY CAN BE ACTIVATED BY ONE 

1108
00:45:44,116 --> 00:45:53,425
PEPTIDE MOLECULE.

1109
00:45:53,425 --> 00:45:55,961
THEY SHOWED IT TO A GROUP OF 

1110
00:45:55,961 --> 00:45:58,330
PATIENTS, SOME OF WHOM GOT 

1111
00:45:58,330 --> 00:46:00,966
SEMAGLUTIDE AND SOME OF WHOM 

1112
00:46:00,966 --> 00:46:02,334
GOT PLACEBO.

1113
00:46:02,334 --> 00:46:04,469
YOU SEE THE WEIGHT LOSS PRETTY 

1114
00:46:04,469 --> 00:46:08,707
REMARKABLE OVER THE 28 WEEKS OF 

1115
00:46:08,707 --> 00:46:08,907
STUDY.

1116
00:46:08,907 --> 00:46:19,418
I SAID DAYS BUT I MEANT WEEKS.

1117
00:46:26,158 --> 00:46:29,027
THE LOSS OF WEIGHT WAS IN THE 

1118
00:46:29,027 --> 00:46:30,028
FAT FRACTION.

1119
00:46:30,028 --> 00:46:32,164
THERE WAS LITTLE CHANGE IN THE 

1120
00:46:32,164 --> 00:46:34,366
GROUPS WHAT THE LEAN TISSUE 

1121
00:46:34,366 --> 00:46:37,602
ENDED UP BEING AT THE END OF 

1122
00:46:37,602 --> 00:46:39,538
THE EXPERIMENT.

1123
00:46:39,538 --> 00:46:42,674
USUALLY WHEN WE LOSE WEIGHT WE 

1124
00:46:42,674 --> 00:46:44,776
LOSE 30% LEAN, 70% FAT.

1125
00:46:44,776 --> 00:46:46,945
THAT SEEMS TO BE WHAT HAPPENED 

1126
00:46:46,945 --> 00:46:49,214
IN THE INCRETIN-BASED DRUG 

1127
00:46:49,214 --> 00:46:50,449
DOLLARS WITH THE LIMITED 

1128
00:46:50,449 --> 00:46:53,018
INFORMATION WE HAVE SO FAR.

1129
00:46:53,018 --> 00:46:56,988
WHEN THEY LOOK AT ONE THAT GOT 

1130
00:46:56,988 --> 00:47:01,493
SEMAGLUTIDE AND ONE THAT GOT 

1131
00:47:01,493 --> 00:47:05,230
TIRZEPATIDE, COMPARED TO 

1132
00:47:05,230 --> 00:47:11,570
PLACEBO, THE DIABETIC SUBJECTS 

1133
00:47:11,570 --> 00:47:12,537
SECRETED MORE.

1134
00:47:12,537 --> 00:47:13,672
THE DOSING IS IMPORTANT WHEN 

1135
00:47:13,672 --> 00:47:16,842
YOU TALK ABOUT RELATIVE 

1136
00:47:16,842 --> 00:47:17,309
POTENCIES.

1137
00:47:17,309 --> 00:47:20,612
I THINK MOST PEOPLE AND MOST 

1138
00:47:20,612 --> 00:47:22,080
PUBLISHED LITERATURE SUPPORTS 

1139
00:47:22,080 --> 00:47:23,748
THE DUAL AGONIST BEING MORE 

1140
00:47:23,748 --> 00:47:25,450
POTENT THAN THE SINGLE.

1141
00:47:25,450 --> 00:47:28,286
IF YOU GAVE A HIGHER DOSE OF 

1142
00:47:28,286 --> 00:47:30,188
THE SINGLE AGONIST YOU MIGHT 

1143
00:47:30,188 --> 00:47:31,623
CATCH UP SOMEWHAT.

1144
00:47:31,623 --> 00:47:35,961
SO WHAT ABOUT CLINICAL TRIALS?

1145
00:47:35,961 --> 00:47:37,829
TZP IN PATIENTS WITH DIABETES.

1146
00:47:37,829 --> 00:47:39,831
WHAT YOU SEE RELATIVELY SHORT 

1147
00:47:39,831 --> 00:47:42,234
STUDY OF 40 WEEKS.

1148
00:47:42,234 --> 00:47:45,770
BUT THE A1C GOING DOWN MORE 

1149
00:47:45,770 --> 00:47:49,941
THAN 2% FROM ABOUT 8.5% TO 6 

1150
00:47:49,941 --> 00:47:52,511
AND FREQUENTLY AT THE HIGH DOSE 

1151
00:47:52,511 --> 00:47:53,345
UNDER 6%.

1152
00:47:53,345 --> 00:48:03,855
AND THE CHANGE IN BODY WEIGHT.

1153
00:48:05,423 --> 00:48:09,661
IN LONGER CLINICAL TRIALS, 

1154
00:48:09,661 --> 00:48:10,762
THESE DRUGS, MULTI-RECEPTOR 

1155
00:48:10,762 --> 00:48:13,231
AGONISTS START TO APPROACH 20% 

1156
00:48:13,231 --> 00:48:15,033
WEIGHT LOSS ON AVERAGE.

1157
00:48:15,033 --> 00:48:20,872
SO AGAIN, VERY POTENT EFFECTS 

1158
00:48:20,872 --> 00:48:22,807
TO CAUSE WEIGHT LOSS AND 

1159
00:48:22,807 --> 00:48:23,942
GLUCOSE LOWERING.

1160
00:48:23,942 --> 00:48:26,478
SO REALLY GOOD DIABETES DRUGS.

1161
00:48:26,478 --> 00:48:28,713
I'M NOT GOING TO GO THROUGH ALL 

1162
00:48:28,713 --> 00:48:30,815
THE CLINICAL TRIALS, BUT JUST 

1163
00:48:30,815 --> 00:48:33,385
TO SUMMARIZE, THE FDA REQUIRES 

1164
00:48:33,385 --> 00:48:35,186
IF INTRODUCE A NEW DIABETES 

1165
00:48:35,186 --> 00:48:38,056
DRUG TO THE MARKET YOU DO A 

1166
00:48:38,056 --> 00:48:39,524
CARDIOVASCULAR SAFETY TRIAL TO 

1167
00:48:39,524 --> 00:48:41,693
PROVE IT DOESN'T CAUSE 

1168
00:48:41,693 --> 00:48:43,061
CARDIOVASCULAR EVENTS.

1169
00:48:43,061 --> 00:48:44,930
AND WITH SEMAGLUTIDE AND NOW 

1170
00:48:44,930 --> 00:48:50,135
WITH  TIRZEPATIDE THERE'S DATA 

1171
00:48:50,135 --> 00:48:51,770
THAT SUGGESTS IF YOU TREAT 

1172
00:48:51,770 --> 00:48:53,238
PEOPLE AT RISK FOR HEART 

1173
00:48:53,238 --> 00:48:55,774
DISEASE WITH THESE DRUGS AND 

1174
00:48:55,774 --> 00:48:58,677
COMPARE WITH PLACEBO, THE 

1175
00:48:58,677 --> 00:48:59,511
EVENTS GO DOWN.

1176
00:48:59,511 --> 00:49:02,047
THERE SEEMS TO BE SOME 

1177
00:49:02,047 --> 00:49:04,382
PROTECTIVE EVENT FOR FURTHER 

1178
00:49:04,382 --> 00:49:04,916
CARDIAC DISEASE.

1179
00:49:04,916 --> 00:49:08,820
THERE'S ALSO DATA NOW ON RENAL 

1180
00:49:08,820 --> 00:49:09,888
FAILURE.

1181
00:49:09,888 --> 00:49:15,126
IF TAKE PATIENTS WITH RENAL 

1182
00:49:15,126 --> 00:49:17,829
FAILURE AND TREAT WITH 

1183
00:49:17,829 --> 00:49:21,232
SEMAGLUTIDE THEY HAVE SLOWER 

1184
00:49:21,232 --> 00:49:22,701
PROGRESSION IN RENAL DISEASE, 

1185
00:49:22,701 --> 00:49:25,403
THIS HAPPENS WITH PATIENTS WHO 

1186
00:49:25,403 --> 00:49:27,872
DON'T HAVE DIABETES.

1187
00:49:27,872 --> 00:49:36,781
IT'S EXPANDED FROM INSULIN 

1188
00:49:36,781 --> 00:49:37,649
SECRETAGOGS, TREATING WEIGHT 

1189
00:49:37,649 --> 00:49:41,353
LOSS AND NOW CARDIO-RENAL 

1190
00:49:41,353 --> 00:49:44,089
ADVERSE EVENTS THAT ARE REALLY 

1191
00:49:44,089 --> 00:49:45,724
THE MORBIDITY OF DIABETES.

1192
00:49:45,724 --> 00:49:48,026
SO IT'S JUST STRIKING.

1193
00:49:48,026 --> 00:49:50,729
THE DATA KEEPS ACCUMULATING.

1194
00:49:50,729 --> 00:49:54,833
TIRZEPATIDE IS REALLY EFFECTIVE 

1195
00:49:54,833 --> 00:49:56,635
IN RESOLVING OBSTRUCTIVE SLEEP 

1196
00:49:56,635 --> 00:49:58,603
APNEA.

1197
00:49:58,603 --> 00:50:01,306
AND BOTH TIRZEPATIDE AND 

1198
00:50:01,306 --> 00:50:03,608
SEMAGLUTIDE HAVE IMPACTS ON 

1199
00:50:03,608 --> 00:50:07,979
METABOLIC LIVER DISEASE, 

1200
00:50:07,979 --> 00:50:12,117
NON-ALCOHOLIC, AT LEAST BY 

1201
00:50:12,117 --> 00:50:13,985
DECREASING STEATOSIS AND 

1202
00:50:13,985 --> 00:50:15,687
HEPATIC FIBROSIS.

1203
00:50:15,687 --> 00:50:18,757
THE POINT DR. ARTERBURN MADE AT 

1204
00:50:18,757 --> 00:50:20,659
THE BEGINNING OF THESE HAVING A 

1205
00:50:20,659 --> 00:50:23,194
BROAD EFFECT ON THE HEALTH 

1206
00:50:23,194 --> 00:50:27,832
RELATED TO DYSMETABOLISM IS 

1207
00:50:27,832 --> 00:50:31,202
BORNE OUT BY REASONABLY SOLID 

1208
00:50:31,202 --> 00:50:32,737
AND REPEATED STUDIES.

1209
00:50:32,737 --> 00:50:34,572
SO WHAT'S THE FUTURE HOLD?

1210
00:50:34,572 --> 00:50:36,841
WELL, I CAN TELL YOU THAT THIS 

1211
00:50:36,841 --> 00:50:39,678
IS AN AREA THAT DOESN'T SEEM 

1212
00:50:39,678 --> 00:50:41,179
CAPPED OUT RIGHT NOW.

1213
00:50:41,179 --> 00:50:43,682
THERE'S JUST A LOT OF ACTIVITY 

1214
00:50:43,682 --> 00:50:47,018
IN THE FIELD FROM SMALL PHARMA 

1215
00:50:47,018 --> 00:50:48,219
TO BIG PHARMA.

1216
00:50:48,219 --> 00:50:52,490
EVERYBODY IS LOOKING FOR NEW, 

1217
00:50:52,490 --> 00:50:54,793
MORE POTENT GLP-1'S.

1218
00:50:54,793 --> 00:50:56,995
AND THE mRNA CONCEPT HAS 

1219
00:50:56,995 --> 00:50:58,129
BLOSSOMED AND PEOPLE ARE 

1220
00:50:58,129 --> 00:51:00,432
PLAYING AROUND WITH MULTIPLE 

1221
00:51:00,432 --> 00:51:07,906
APPROACHES TO MULTI-RECEPTOR 

1222
00:51:07,906 --> 00:51:08,139
AGONISM.

1223
00:51:08,139 --> 00:51:10,575
SMALL MOLECULE AGENTS BEING 

1224
00:51:10,575 --> 00:51:11,676
DEVELOPED.

1225
00:51:11,676 --> 00:51:13,645
SO ORAL AGENTS CAN BE TAKEN 

1226
00:51:13,645 --> 00:51:15,814
ALSO ACT THROUGH THE SYSTEM.

1227
00:51:15,814 --> 00:51:18,116
OF COURSE SMALL MOLECULES ARE 

1228
00:51:18,116 --> 00:51:20,218
WAY CHEAPER TO MAKE THAN 

1229
00:51:20,218 --> 00:51:22,921
PEPTIDES AND DON'T REQUIRE PEN 

1230
00:51:22,921 --> 00:51:23,822
INJECTORS AND NEEDLES AND ALL 

1231
00:51:23,822 --> 00:51:25,657
THAT STUFF.

1232
00:51:25,657 --> 00:51:27,992
WE CONTINUE TO GENERATE A 

1233
00:51:27,992 --> 00:51:29,861
DEEPER UNDERSTANDING OF THE 

1234
00:51:29,861 --> 00:51:30,695
RELEVANT BIOLOGY.

1235
00:51:30,695 --> 00:51:33,398
A LOT OF THIS IS BACK FILLING.

1236
00:51:33,398 --> 00:51:35,166
WE HAVE DRUGS THAT ARE VERY 

1237
00:51:35,166 --> 00:51:36,735
EFFECTIVE AND NOW WE ARE TRYING 

1238
00:51:36,735 --> 00:51:38,069
TO FIGURE OUT WHY THEY ARE 

1239
00:51:38,069 --> 00:51:38,937
EFFECTIVE.

1240
00:51:38,937 --> 00:51:44,576
IF A DUAL AGONIST, IF A GLP GIP 

1241
00:51:44,576 --> 00:51:47,912
IS GOOD, WOULD IT BE BETTER TO 

1242
00:51:47,912 --> 00:51:53,785
ADD A GLUCAGON?

1243
00:51:53,785 --> 00:51:55,220
RETATRUTIDE CAUSES ON AVERAGE 

1244
00:51:55,220 --> 00:51:59,591
CLOSE TO 25% BODY WEIGHT LOSS.

1245
00:51:59,591 --> 00:52:01,926
A QUARTER PATIENTS LOSE 30% OF 

1246
00:52:01,926 --> 00:52:12,403
BODY WEIGHT, WHICH IS NOW  

1247
00:52:13,171 --> 00:52:14,272
BARIATRIC-LEVEL WEIGHT LOSS.

1248
00:52:14,272 --> 00:52:20,311
IF YOU LOOK AT TRY AGONIST IT 

1249
00:52:20,311 --> 00:52:24,549
DROPS A1C, DECREASES TRY 

1250
00:52:24,549 --> 00:52:25,483
GLYCERIDE, CHOLESTEROL.

1251
00:52:25,483 --> 00:52:27,919
WE SEE WITH THE INCRETIN-BASED 

1252
00:52:27,919 --> 00:52:28,787
DRUGS.

1253
00:52:28,787 --> 00:52:30,255
THEY ARE EXPECTED GIVEN THE 

1254
00:52:30,255 --> 00:52:32,157
AMOUNT OF WEIGHT LOSS THESE 

1255
00:52:32,157 --> 00:52:34,192
DRUGS CONFER.

1256
00:52:34,192 --> 00:52:38,897
THE SMALL MOLECULE AGENTS, YOU 

1257
00:52:38,897 --> 00:52:41,032
KNOW, CAN SHOW YOU CAN MAKE A 

1258
00:52:41,032 --> 00:52:44,102
SMALL MOLECULE THAT SITS IN THE 

1259
00:52:44,102 --> 00:52:45,503
GLP-1 RECEPTOR BINDING POCKET, 

1260
00:52:45,503 --> 00:52:48,239
GIVES YOU A DOSE RESPONSE.

1261
00:52:48,239 --> 00:52:51,776
AGAIN, SINGLE PILL, DROPS THE 

1262
00:52:51,776 --> 00:52:53,845
A1C ALMOST 2%.

1263
00:52:53,845 --> 00:52:55,880
JUST MIND BLOWING IF YOU HAVE 

1264
00:52:55,880 --> 00:52:57,081
BEEN TREATING DIABETES AS LONG 

1265
00:52:57,081 --> 00:52:58,950
AS I HAVE.

1266
00:52:58,950 --> 00:53:01,486
THE WEIGHT LOSS EFFECT, 10 

1267
00:53:01,486 --> 00:53:03,521
KILOGRAMS WITH A SINGLE PILL.

1268
00:53:03,521 --> 00:53:04,956
THERE'S LOTS MORE WHERE THIS 

1269
00:53:04,956 --> 00:53:07,058
COMES FROM, THIS IS A VERY HOT 

1270
00:53:07,058 --> 00:53:07,258
AREA.

1271
00:53:07,258 --> 00:53:12,397
EVERYBODY WOULD LIKE TO CONQUER 

1272
00:53:12,397 --> 00:53:14,265
THE SMALL MOLECULE SPACE.

1273
00:53:14,265 --> 00:53:16,334
SO WHAT ARE THE DOWN SIDES OF 

1274
00:53:16,334 --> 00:53:17,168
THE REVOLUTION HERE.

1275
00:53:17,168 --> 00:53:18,636
YOU CAN READ ABOUT SOME OF 

1276
00:53:18,636 --> 00:53:20,271
THESE IN THE HUMAN INTEREST 

1277
00:53:20,271 --> 00:53:21,873
SECTION OF THE "NEW YORK TIMES".

1278
00:53:21,873 --> 00:53:23,608
I WILL GIVE YOU MY TAKE.

1279
00:53:23,608 --> 00:53:27,412
THEY DO HAVE GI TOXICITY, IT'S 

1280
00:53:27,412 --> 00:53:27,712
PREDICTABLE.

1281
00:53:27,712 --> 00:53:29,247
ABOUT HALF OF PEOPLE ARE GOING 

1282
00:53:29,247 --> 00:53:31,583
TO GET NAUSEA, SOME WILL GET 

1283
00:53:31,583 --> 00:53:33,885
VOMITING, SOMETIMES DIARRHEA, 

1284
00:53:33,885 --> 00:53:39,691
SOMETIMES CONSPACING.

1285
00:53:39,691 --> 00:53:42,794
CONSSTI PACING.

1286
00:53:42,794 --> 00:53:46,297
STI CONSTIPATION.

1287
00:53:46,297 --> 00:53:47,999
QUESTIONS ABOUT PANCREATITIS, I 

1288
00:53:47,999 --> 00:53:50,235
DON'T THINK BORNE OUT.

1289
00:53:50,235 --> 00:53:52,303
SOMETIMES DEHYDRATION FROM GI 

1290
00:53:52,303 --> 00:53:54,906
TOXICITY AND DECREASE IN RENAL 

1291
00:53:54,906 --> 00:53:55,173
FUNCTION.

1292
00:53:55,173 --> 00:53:56,975
LOW RATES OF DRUG PERSISTENCE, 

1293
00:53:56,975 --> 00:53:59,143
WE ARE TALK ABOUT THIS.

1294
00:53:59,143 --> 00:53:59,978
VARIABLE ACCESS.

1295
00:53:59,978 --> 00:54:02,680
I HAVE A LOT OF PEOPLE WHO CALL 

1296
00:54:02,680 --> 00:54:04,315
THESE RICH PEOPLE DRUGS, IF YOU 

1297
00:54:04,315 --> 00:54:05,984
DON'T HAVE GOLD PLATED 

1298
00:54:05,984 --> 00:54:07,619
INSURANCE OR MONEY IN THE BANK 

1299
00:54:07,619 --> 00:54:09,921
OFTEN TIMES YOU HAVE TROUBLE 

1300
00:54:09,921 --> 00:54:10,922
GETTING THESE DRUGS.

1301
00:54:10,922 --> 00:54:12,824
WE DISAPPOINT HAVE LONG-TERM 

1302
00:54:12,824 --> 00:54:15,426
OUTCOME STUDIES.

1303
00:54:15,426 --> 00:54:16,327
LIMITED UNDERSTANDING OF 

1304
00:54:16,327 --> 00:54:17,495
MECHANISMS.

1305
00:54:17,495 --> 00:54:20,198
THEY ARE EXPENSIVE TO PRODUCE, 

1306
00:54:20,198 --> 00:54:21,432
SHIP AND STORE.

1307
00:54:21,432 --> 00:54:24,135
AND AS MORE AND MORE DRUG COSTS 

1308
00:54:24,135 --> 00:54:26,004
ARE PASSED ONTO PATIENTS THEY 

1309
00:54:26,004 --> 00:54:27,839
ARE VERY EXPENSIVE FOR THEM.

1310
00:54:27,839 --> 00:54:30,541
>> Darren 

1311
00:54:30,541 --> 00:54:31,175
-- 

1312
00:54:31,175 --> 00:54:33,311
>> Kimberly Narain: DR.,
TWO 

1313
00:54:33,311 --> 00:54:34,045
MINUTES LEFT.

1314
00:54:34,045 --> 00:54:36,648
>> David D'Alessio: OKAY,
THANK 

1315
00:54:36,648 --> 00:54:36,814
YOU.

1316
00:54:36,814 --> 00:54:39,217
THESE ARE PATIENTS GIVEN 

1317
00:54:39,217 --> 00:54:40,718
SEMAGLUTIDE FOR 20 WEEKS AND 

1318
00:54:40,718 --> 00:54:43,121
HALF THE GROUP WAS SWITCHED TO 

1319
00:54:43,121 --> 00:54:44,822
PLACEBO AND HALF THE GROUP 

1320
00:54:44,822 --> 00:54:45,189
CONTINUED.

1321
00:54:45,189 --> 00:54:47,225
YOU COULD SEE THE WEIGHT LOSS 

1322
00:54:47,225 --> 00:54:49,127
CONTINUES BUT AS SOON AS YOU 

1323
00:54:49,127 --> 00:54:51,562
STOP THE DRUGS THE WEIGHT COMES 

1324
00:54:51,562 --> 00:54:51,763
BACK.

1325
00:54:51,763 --> 00:54:54,899
THAT RAISES THE QUESTION, ARE 

1326
00:54:54,899 --> 00:54:56,167
THESE FOREVER TREATMENTS OR IS 

1327
00:54:56,167 --> 00:54:57,835
IT POSSIBLE THEY WOULD CHANGE 

1328
00:54:57,835 --> 00:55:00,138
SORT OF BODY WEIGHT REGULATION 

1329
00:55:00,138 --> 00:55:00,972
INTERNALLY AT SOME POINT.

1330
00:55:00,972 --> 00:55:02,540
THE JURY IS OUT.

1331
00:55:02,540 --> 00:55:04,876
BUT THESE KIND OF DATA ARE 

1332
00:55:04,876 --> 00:55:05,576
DISCOURAGING.

1333
00:55:05,576 --> 00:55:07,745
THIS TALKS ABOUT ADHERENCE.

1334
00:55:07,745 --> 00:55:09,847
THIS IS JUST A BUNCH OF WEIGHT 

1335
00:55:09,847 --> 00:55:11,182
LOSS DRUGS.

1336
00:55:11,182 --> 00:55:14,085
SOME LIKE SEMAGLUTIDE THAT ARE 

1337
00:55:14,085 --> 00:55:18,890
EFFECTIVE, SOME LIKE ORLISTAT, 

1338
00:55:18,890 --> 00:55:20,525
NOT EFFECTIVE.

1339
00:55:20,525 --> 00:55:24,963
THE NUMBER OF PATIENTS RENEWING 

1340
00:55:24,963 --> 00:55:26,297
PRESCRIPTIONS OVER TIME GOES 

1341
00:55:26,297 --> 00:55:27,432
DOWN STEADILY.

1342
00:55:27,432 --> 00:55:32,670
THIS HAS BEEN BORNE OUT, SEEMS 

1343
00:55:32,670 --> 00:55:33,972
PERSISTENCE WITH PRESCRIPTION 

1344
00:55:33,972 --> 00:55:37,241
REFILLS AT A YEAR IS ABOUT 50%.

1345
00:55:37,241 --> 00:55:39,944
IT'S BETTER THAN PATIENTS WITH 

1346
00:55:39,944 --> 00:55:42,046
TYPE 2 DIABETES THAN WITHOUT.

1347
00:55:42,046 --> 00:55:43,881
BUT AGAIN, IT'S REALLY 

1348
00:55:43,881 --> 00:55:44,983
SURPRISING BECAUSE PEOPLE COME 

1349
00:55:44,983 --> 00:55:46,584
IN ASKING FOR THESE DRUGS BUT 

1350
00:55:46,584 --> 00:55:49,921
AFTER A WHILE THEY STOP THEM.

1351
00:55:49,921 --> 00:55:51,556
THIS STUDY PUBLISHED THIS YEAR, 

1352
00:55:51,556 --> 00:55:54,659
THEY LOOKED FOR FEATURES, OLDER 

1353
00:55:54,659 --> 00:55:56,594
PEOPLE STOPPED, MORE PEOPLE WHO 

1354
00:55:56,594 --> 00:55:57,795
HAD PERSISTENT G.

1355
00:55:57,795 --> 00:55:58,863
I. SIDE EFFECTS STOPPED THEM 

1356
00:55:58,863 --> 00:55:59,697
MORE.

1357
00:55:59,697 --> 00:56:01,799
THERE WAS AN EFFECT OF YOUR 

1358
00:56:01,799 --> 00:56:04,635
INCOME AT HOME BUT IT DIDN'T 

1359
00:56:04,635 --> 00:56:06,137
FAVOR DISCONTINUATION.

1360
00:56:06,137 --> 00:56:09,307
MY BET IF THIS WAS STRATIFIED 

1361
00:56:09,307 --> 00:56:10,708
BY CO-PAY RATHER THAN INCOME IT 

1362
00:56:10,708 --> 00:56:12,176
WOULD BE OVER HERE.

1363
00:56:12,176 --> 00:56:15,880
BECAUSE THESE DRUGS ARE 

1364
00:56:15,880 --> 00:56:16,147
EXPENSIVE.

1365
00:56:16,147 --> 00:56:19,417
SEMAGLUTIDE, $1500 A MONTH.

1366
00:56:19,417 --> 00:56:20,885
TIRZEPATIDE $1200.

1367
00:56:20,885 --> 00:56:22,987
TIRZEPATIDE CAME OUT WITH 

1368
00:56:22,987 --> 00:56:24,422
PATIENT-FRIENDLY PRICING IF 

1369
00:56:24,422 --> 00:56:25,790
YOUR INSURANCE DOESN'T COVER IT.

1370
00:56:25,790 --> 00:56:28,192
BUT LOOK AT THESE MONTHLY 

1371
00:56:28,192 --> 00:56:28,426
CHARGES.

1372
00:56:28,426 --> 00:56:29,594
THESE ARE LUXURY GOODS FOR A 

1373
00:56:29,594 --> 00:56:32,096
LOT OF THE POPULATION.

1374
00:56:32,096 --> 00:56:39,704
SO IN TERMS OF THE PLEA TROPIC 

1375
00:56:39,704 --> 00:56:41,539
EFFECTS.

1376
00:56:41,539 --> 00:56:43,041
YOU COULD SEE ARTICLES THAT 

1377
00:56:43,041 --> 00:56:44,609
TALK ABOUT THE BENEFITS.

1378
00:56:44,609 --> 00:56:46,210
WE KNOW HEART AND KIDNEY, THESE 

1379
00:56:46,210 --> 00:56:47,378
ARE BENEFICIAL.

1380
00:56:47,378 --> 00:56:50,081
ON THE OTHER HAND, WE REALLY 

1381
00:56:50,081 --> 00:56:52,550
KNOW THAT THE RECEPTORS ARE IN 

1382
00:56:52,550 --> 00:56:53,584
THESE TWO PLACES.

1383
00:56:53,584 --> 00:56:55,453
IT'S HARD TO FIND CONVINCING 

1384
00:56:55,453 --> 00:56:57,522
EVIDENCE THAT THESE OTHER 

1385
00:56:57,522 --> 00:56:58,956
TISSUES ARE DIRECTLY AFFECTED.

1386
00:56:58,956 --> 00:57:02,727
THE QUESTION IS HOW MUCH 

1387
00:57:02,727 --> 00:57:04,128
PLEIOTROPY IS THERE, WHAT ARE 

1388
00:57:04,128 --> 00:57:05,663
THE MECHANISMS AND IS IT 

1389
00:57:05,663 --> 00:57:07,698
POSSIBLE THESE ARE BRAIN DRUGS 

1390
00:57:07,698 --> 00:57:09,967
AND ALL THE BENEFICIAL EFFECTS, 

1391
00:57:09,967 --> 00:57:11,903
EVEN ON INSULIN SECRETION ARE 

1392
00:57:11,903 --> 00:57:13,371
MEDIATED BY THE BRAIN.

1393
00:57:13,371 --> 00:57:15,006
THE CLINICAL QUESTIONS ARE WE 

1394
00:57:15,006 --> 00:57:16,674
NEED MORE LONG-TERM DATA.

1395
00:57:16,674 --> 00:57:19,143
IS IT HARMFUL TO STOP AND START?

1396
00:57:19,143 --> 00:57:21,245
BECAUSE THAT'S WHAT HAPPENS.

1397
00:57:21,245 --> 00:57:22,680
YOUR INSURANCE COVERS A WHILE, 

1398
00:57:22,680 --> 00:57:24,549
THEN STOPS THEN YOU RESTART.

1399
00:57:24,549 --> 00:57:26,084
UP AND DOWN BODY WEIGHT, IS 

1400
00:57:26,084 --> 00:57:27,251
THAT GOOD?

1401
00:57:27,251 --> 00:57:28,920
THEN WHAT'S THE PROPER 

1402
00:57:28,920 --> 00:57:31,456
ALLOCATION OF THESE DRUGS.

1403
00:57:31,456 --> 00:57:32,957
THE INCRETIN EFFECT IS NOW 

1404
00:57:32,957 --> 00:57:34,592
ABOUT 100 YEARS OLD AND 

1405
00:57:34,592 --> 00:57:36,294
UNDERSTANDING IT OPENED THE 

1406
00:57:36,294 --> 00:57:38,429
DOOR TO AN IMPORTANT NEW CLASS 

1407
00:57:38,429 --> 00:57:42,467
OF THERAPEUTICS.

1408
00:57:42,467 --> 00:57:45,470
THE GLP-1 R SYSTEM IS A GREAT 

1409
00:57:45,470 --> 00:57:46,170
DRUG TARGET.

1410
00:57:46,170 --> 00:57:48,272
I DON'T THINK WE ARE CLOSE TO 

1411
00:57:48,272 --> 00:57:49,507
MAXIMIZING THE IMPACT OF THESE 

1412
00:57:49,507 --> 00:57:52,009
DRUGS BECAUSE THE TOXICITY DOES 

1413
00:57:52,009 --> 00:57:54,078
LOOM ONCE YOU GET TO A CERTAIN 

1414
00:57:54,078 --> 00:57:54,278
DOSE.

1415
00:57:54,278 --> 00:57:56,581
I THINK THIS IS STILL A DYNAMIC 

1416
00:57:56,581 --> 00:57:57,849
AREA OF DRUG DEVELOPMENT AND 

1417
00:57:57,849 --> 00:57:59,450
THERE WILL BE A LOT OF ACTIVITY 

1418
00:57:59,450 --> 00:58:02,353
IN THE NEXT DECADE AS NEW DRUGS 

1419
00:58:02,353 --> 00:58:02,687
ARE DEVELOPED.

1420
00:58:02,687 --> 00:58:04,822
BUT I THINK TO BEND THE CURVES, 

1421
00:58:04,822 --> 00:58:07,058
TO ACTUALLY CHANGE THE 

1422
00:58:07,058 --> 00:58:09,127
INCREASING RATES OF DIABETES 

1423
00:58:09,127 --> 00:58:10,761
AND OBESITY IN THE U.S. AND THE 

1424
00:58:10,761 --> 00:58:12,396
WORLD WE HAVE TO HAVE DRUGS 

1425
00:58:12,396 --> 00:58:15,366
THAT HAVE GREATER AVAILABLITY 

1426
00:58:15,366 --> 00:58:16,801
AND EXPANDED ACCESS TO THE MANY 

1427
00:58:16,801 --> 00:58:18,136
WHO NEED THEM.

1428
00:58:18,136 --> 00:58:19,704
WE DON'T HAVE THAT IN THE 

1429
00:58:19,704 --> 00:58:21,539
CURRENT GENERATION OF DRUGS.

1430
00:58:21,539 --> 00:58:31,849
THANKS VERY MUCH.

1431
00:58:32,850 --> 00:58:36,120
HAPPY TO TAKE ANY QUESTIONS.

1432
00:58:36,120 --> 00:58:37,588
>> Kimberly Narain: THANK
YOU 

1433
00:58:37,588 --> 00:58:44,028
FOR THAT, REALLY JUST AMAZING 

1434
00:58:44,028 --> 00:58:44,962
TALK, DR. D'ALESSIO.

1435
00:58:44,962 --> 00:58:46,531
BEFORE WE JUMP IN THE Q&A 

1436
00:58:46,531 --> 00:58:48,366
PORTION, A QUICK REMINDER, 

1437
00:58:48,366 --> 00:58:50,201
PLEASE PUT YOUR QUESTIONS IN 

1438
00:58:50,201 --> 00:58:59,277
THE Q&A SECTION.

1439
00:58:59,277 --> 00:59:01,145
I WILL TAKE THE LIBERTY OF 

1440
00:59:01,145 --> 00:59:02,613
ASKING THE FIRST QUESTION, 

1441
00:59:02,613 --> 00:59:04,182
BECAUSE I CAN.

1442
00:59:04,182 --> 00:59:05,583
WHEN I WAS GOING BACK THROUGH 

1443
00:59:05,583 --> 00:59:07,885
SOME OF YOUR PAPERS, IN THE 

1444
00:59:07,885 --> 00:59:10,054
EARLY 2000'S YOU AND YOUR TEAM 

1445
00:59:10,054 --> 00:59:12,056
PUBLISHED A PAPER WHERE YOU 

1446
00:59:12,056 --> 00:59:15,159
GUYS IDENTIFIED THERE WERE SOME 

1447
00:59:15,159 --> 00:59:17,862
GLP-1 RECEPTORS THAT COULD BE 

1448
00:59:17,862 --> 00:59:20,398
STIMULATED TO PRODUCE ANOREXIA, 

1449
00:59:20,398 --> 00:59:24,368
BUT NOT PRODUCE A SIGNIFICANT 

1450
00:59:24,368 --> 00:59:27,505
AMOUNT OF GASTROINTESTINAL 

1451
00:59:27,505 --> 00:59:27,705
UPSET.

1452
00:59:27,705 --> 00:59:29,807
TALK TO ME ABOUT WHEN AND HOW 

1453
00:59:29,807 --> 00:59:31,475
YOU FIGURED OUT THAT DISCOVERY 

1454
00:59:31,475 --> 00:59:34,512
HAD THE POTENTIAL TO HELP 

1455
00:59:34,512 --> 00:59:36,080
REVOLUTIONARY THE WAY THAT WE 

1456
00:59:36,080 --> 00:59:37,882
MANAGE OBESITY?

1457
00:59:37,882 --> 00:59:41,018
>> David D'Alessio: YEAH.

1458
00:59:41,018 --> 00:59:42,887
THAT WAS PROMPTED, I MEAN WHEN 

1459
00:59:42,887 --> 00:59:48,159
I GOT AN IND TO GIVE NATIVE GLP 

1460
00:59:48,159 --> 00:59:50,728
TO HUMANS WHEN I WAS JUST 

1461
00:59:50,728 --> 00:59:51,062
STARTING OUT.

1462
00:59:51,062 --> 00:59:52,363
WE WITH PLAYING AROUND WITH THE 

1463
00:59:52,363 --> 00:59:52,563
DOSES.

1464
00:59:52,563 --> 00:59:55,499
WE COULDN'T GET TO A MAXIMUM OF 

1465
00:59:55,499 --> 00:59:57,401
INSULIN SECRETION BECAUSE 

1466
00:59:57,401 --> 00:59:58,402
PEOPLE GOT NAUSEATED BEFORE WE 

1467
00:59:58,402 --> 00:59:59,503
HIT THAT.

1468
00:59:59,503 --> 01:00:01,672
THEN IT BECAME APPARENT IF YOU 

1469
01:00:01,672 --> 01:00:04,108
PUSH THE THERAPEUTIC WINDOW AND 

1470
01:00:04,108 --> 01:00:06,410
GIVE HIGH DOSES YOU NEED TO TRY 

1471
01:00:06,410 --> 01:00:09,280
TO UNDERSTAND THE NAUSEA ISSUE.

1472
01:00:09,280 --> 01:00:11,749
AND YOU KNOW, IN EARLY 2000'S 

1473
01:00:11,749 --> 01:00:12,817
THERE WERE TWO SCHOOLS OF 

1474
01:00:12,817 --> 01:00:13,618
THOUGHT.

1475
01:00:13,618 --> 01:00:15,486
ONE WAS THAT NAUSEA WAS 

1476
01:00:15,486 --> 01:00:18,823
MEDIATED BY A DISTINCT GROUP OF 

1477
01:00:18,823 --> 01:00:24,595
NEURONS IN THE HINDBRAIN AND 

1478
01:00:24,595 --> 01:00:26,030
SATIETY IN ANOTHER GROUP.

1479
01:00:26,030 --> 01:00:27,732
ANOTHER GROUP OF SCIENTISTS 

1480
01:00:27,732 --> 01:00:29,867
SAID NO IT'S THE SAME GROUP OF 

1481
01:00:29,867 --> 01:00:32,670
NEURONS, YOU WON'T BE ABLE TO 

1482
01:00:32,670 --> 01:00:33,004
SEPARATE THAT.

1483
01:00:33,004 --> 01:00:35,106
OUR DATA WAS OKAY IN DOING 

1484
01:00:35,106 --> 01:00:36,974
THAT, WE WERE CONVINCED, I 

1485
01:00:36,974 --> 01:00:40,344
THINK A LOT OF PEOPLE WERE.

1486
01:00:40,344 --> 01:00:43,281
THERE HAVE BEEN NICE PAPERS BY 

1487
01:00:43,281 --> 01:00:45,983
HIGH END NEUROSCIENTISTS IN THE 

1488
01:00:45,983 --> 01:00:47,018
TECHNOLOGY AVAILABLE TO THEM 

1489
01:00:47,018 --> 01:00:49,987
THAT MAKES A CLEAR CASE THAT 

1490
01:00:49,987 --> 01:00:52,857
THE SATIETY IS MEETED AT A 

1491
01:00:52,857 --> 01:00:55,159
DIFFERENT SITE IN THE BRAIN 

1492
01:00:55,159 --> 01:00:57,395
THAN NAUSEA AND YOU CAN 

1493
01:00:57,395 --> 01:01:01,299
SEPARATE THEM, IN TERMS OF 

1494
01:01:01,299 --> 01:01:02,300
NEURO CIRCUITRY, NOW WHETHER 

1495
01:01:02,300 --> 01:01:04,802
THAT COULD BE TAKEN ADVANTAGE 

1496
01:01:04,802 --> 01:01:06,637
OF WITH THESE DRUGS TO TARGET 

1497
01:01:06,637 --> 01:01:08,339
ONE OVER THE OTHER IS THE 

1498
01:01:08,339 --> 01:01:09,240
QUESTION, THAT WOULD TAKE A LOT 

1499
01:01:09,240 --> 01:01:10,574
MORE WORK.

1500
01:01:10,574 --> 01:01:12,243
THE ONE THING I WOULD SAY, 

1501
01:01:12,243 --> 01:01:14,545
THERE'S SOME NOTION THAT GIP, 

1502
01:01:14,545 --> 01:01:15,946
WHICH ALSO WORKS IN THE BRAIN 

1503
01:01:15,946 --> 01:01:19,917
AND IN THE SAME AREAS AS GLP, 

1504
01:01:19,917 --> 01:01:21,986
THERE'S SOME PRE-CLINICAL DATA 

1505
01:01:21,986 --> 01:01:24,889
THAT SUGGESTS GIP ACTUALLY 

1506
01:01:24,889 --> 01:01:27,391
MITIGATES NAUSEA OF GLP-1 AND 

1507
01:01:27,391 --> 01:01:29,060
ONE ARGUMENT WITH TIRZEPATIDE 

1508
01:01:29,060 --> 01:01:31,329
IS MORE POTENT IS YOU CAN PUSH 

1509
01:01:31,329 --> 01:01:32,396
THE DOSE HARDER BECAUSE YOU 

1510
01:01:32,396 --> 01:01:35,666
DON'T GET AS MUCH NAUSEA.

1511
01:01:35,666 --> 01:01:37,268
THERE'S NO HEAD-TO-HEAD THAT'S 

1512
01:01:37,268 --> 01:01:38,169
REALLY DEMONSTRATED THAT.

1513
01:01:38,169 --> 01:01:40,638
BUT WHEN I TALK TO MY 

1514
01:01:40,638 --> 01:01:42,940
COLLEAGUES IN THE CLINIC, THE 

1515
01:01:42,940 --> 01:01:44,408
YOUNGER DOCS USE MORE OF THIS 

1516
01:01:44,408 --> 01:01:45,609
STUFF THAN I DO, THEY FAVOR 

1517
01:01:45,609 --> 01:01:46,477
THAT.

1518
01:01:46,477 --> 01:01:50,147
THEY THINK TIRZ  TIRZEPATIDE 

1519
01:01:50,147 --> 01:01:51,816
MIGHT BE BETTER TOLERATED.

1520
01:01:51,816 --> 01:01:54,318
I THINK THERE'S SOME PRECEDENT 

1521
01:01:54,318 --> 01:01:56,187
THAT BY MANIPULATING THESE 

1522
01:01:56,187 --> 01:01:59,724
DRUGS YOU MAY BE ABLE TO FAVOR 

1523
01:01:59,724 --> 01:02:01,625
EFFICACY OVER TOXICITY AND 

1524
01:02:01,625 --> 01:02:05,763
WIDEN THE THEY'RE  THERAPEUTIC 

1525
01:02:05,763 --> 01:02:08,566
WINDOW AND THAT WOULD BE 

1526
01:02:08,566 --> 01:02:08,799
HELPFUL.

1527
01:02:08,799 --> 01:02:11,602
ANOTHER THING, A PREAMBLE TO 

1528
01:02:11,602 --> 01:02:12,570
THIS WORKSHOP, THIS IS VERY 

1529
01:02:12,570 --> 01:02:14,105
TIMELY.

1530
01:02:14,105 --> 01:02:15,940
REAL-WORLD EVIDENCE AND THIS 

1531
01:02:15,940 --> 01:02:19,310
LINE OF ANALYSIS IS WHAT IS 

1532
01:02:19,310 --> 01:02:19,543
LACKING.

1533
01:02:19,543 --> 01:02:20,978
WHEN I LIST THE DOWN SIDES 

1534
01:02:20,978 --> 01:02:22,813
THESE ARE THE KINDS OF THINGS I 

1535
01:02:22,813 --> 01:02:24,482
THINK COULD BE REALLY 

1536
01:02:24,482 --> 01:02:25,716
IMPORTANTLY ADDRESSED BY THE 

1537
01:02:25,716 --> 01:02:26,951
SORTS OF QUESTIONS THAT ARE 

1538
01:02:26,951 --> 01:02:29,487
GOING TO COME OF THIS MEETING.

1539
01:02:29,487 --> 01:02:32,757
SO I WAS REALLY DELIGHTED TO BE 

1540
01:02:32,757 --> 01:02:32,990
INVITED.

1541
01:02:32,990 --> 01:02:34,658
I HOPE TO LEARN A LOT.

1542
01:02:34,658 --> 01:02:36,394
>> David 

1543
01:02:36,394 --> 01:02:37,561
>> Kimberly Narain: I
THINK 

1544
01:02:37,561 --> 01:02:39,563
MAYBE WE HAVE TIME FOR ONE MORE 

1545
01:02:39,563 --> 01:02:39,830
QUESTION.

1546
01:02:39,830 --> 01:02:43,300
I'M LOOKING IN THE CHAT.

1547
01:02:43,300 --> 01:02:49,774
I'M SEEING MOSTLY COMMENTEDS 

1548
01:02:49,774 --> 01:02:50,808
ABOUT EVIDENCE GAPS.

1549
01:02:50,808 --> 01:02:52,743
I WILL ASK AN ADDITIONAL 

1550
01:02:52,743 --> 01:02:53,110
QUESTION.

1551
01:02:53,110 --> 01:02:56,814
I WILL BE A LITTLE BIT SELFISH 

1552
01:02:56,814 --> 01:02:58,449
HERE.

1553
01:02:58,449 --> 01:03:00,518
US JUNIOR RESEARCHERS TEND TO 

1554
01:03:00,518 --> 01:03:02,820
BE VERY IN THE WEEDS WHEN WE 

1555
01:03:02,820 --> 01:03:06,123
ARE THINKING ABOUT OUR RESEARCH 

1556
01:03:06,123 --> 01:03:08,459
AND VERY FOCUSED ON WHAT'S 

1557
01:03:08,459 --> 01:03:10,694
RIGHT IN FRONT OF US AND NOT 

1558
01:03:10,694 --> 01:03:13,431
NECESSARILY THE PRACTICAL STEPS 

1559
01:03:13,431 --> 01:03:14,865
THAT IT WOULD TAKE TO SEE THE 

1560
01:03:14,865 --> 01:03:18,335
KNOWLEDGE WE ARE TRYING TO 

1561
01:03:18,335 --> 01:03:19,937
PRODUCE TRANSLATED INTO THE 

1562
01:03:19,937 --> 01:03:30,214
REAL IMPACT THAT WE SEEK.

1563
01:03:30,214 --> 01:03:31,415
THAT DIDN'T HAPPEN WITH YOU, 

1564
01:03:31,415 --> 01:03:33,317
YOU WERE THERE TO TAKE THAT 

1565
01:03:33,317 --> 01:03:35,886
JOURNEY TO SEE IT TRANSLATED 

1566
01:03:35,886 --> 01:03:38,088
INTO THE BEDSIDE THERAPIES.

1567
01:03:38,088 --> 01:03:39,390
HOW DID YOU POSITION YOURSELF 

1568
01:03:39,390 --> 01:03:40,124
TO DO THAT?

1569
01:03:40,124 --> 01:03:43,994
>> David D'Alessio: I
WOULD SAY 

1570
01:03:43,994 --> 01:03:44,295
BLIND LUCK.

1571
01:03:44,295 --> 01:03:46,464
BUT THE REALITY IS A COUPLE OF 

1572
01:03:46,464 --> 01:03:48,566
THE EARLY STUDIES WE DID, WE 

1573
01:03:48,566 --> 01:03:50,634
GOT RESULTS THAT WE DIDN'T 

1574
01:03:50,634 --> 01:03:50,868
EXPECT.

1575
01:03:50,868 --> 01:03:53,337
SO WE WERE GIVEN GLP-1 

1576
01:03:53,337 --> 01:03:56,407
EXPECTING TOO SEE EFFECTS ON 

1577
01:03:56,407 --> 01:03:58,342
INSULIN SECRETION AND 

1578
01:03:58,342 --> 01:03:58,943
SENSITIVITY.

1579
01:03:58,943 --> 01:04:01,645
WE DIDN'T SEE EFFECTS ON 

1580
01:04:01,645 --> 01:04:06,817
SENSITIVITY EVEN THOUGH THE 

1581
01:04:06,817 --> 01:04:08,786
GLUCOSE DISPOSAL WAS QUICK.

1582
01:04:08,786 --> 01:04:12,790
THERE WAS AN INSULIN EFFECT AND 

1583
01:04:12,790 --> 01:04:13,324
INSULIN-DEPENDENT EFFECT.

1584
01:04:13,324 --> 01:04:15,392
THAT IS IN THE WEEDS.

1585
01:04:15,392 --> 01:04:17,695
BUT THAT SPOKE TO OTHER, MUST 

1586
01:04:17,695 --> 01:04:18,496
BE OTHER MECHANISMS.

1587
01:04:18,496 --> 01:04:20,164
AND A LOT OF PEOPLE WERE 

1588
01:04:20,164 --> 01:04:21,866
TELLING US OUR METHODS WERE 

1589
01:04:21,866 --> 01:04:26,036
FLAWED AND THIS WAS AN ARTIFACT.

1590
01:04:26,036 --> 01:04:28,906
WE JUST KEPT AT IT, WHAT THAT 

1591
01:04:28,906 --> 01:04:31,008
TOOK US TO WAS FROM THE EYELET 

1592
01:04:31,008 --> 01:04:32,009
TO THE BRAIN.

1593
01:04:32,009 --> 01:04:36,547
WHAT WE WERE CALLING EXTRA 

1594
01:04:36,547 --> 01:04:38,415
PANCREATIC EFFECT WAS BRAIN.

1595
01:04:38,415 --> 01:04:41,685
AT THE SAME TIME LOTS OF OTHER 

1596
01:04:41,685 --> 01:04:42,786
PEOPLE, PROPER NEUROSCIENCE 

1597
01:04:42,786 --> 01:04:44,121
WERE DOING THIS WORK AND IT 

1598
01:04:44,121 --> 01:04:45,055
JUST MERGED.

1599
01:04:45,055 --> 01:04:46,957
WHAT I ALWAYS TELL OUR YOUNG 

1600
01:04:46,957 --> 01:04:49,260
PEOPLE, IF YOU BELIEVE YOUR 

1601
01:04:49,260 --> 01:04:55,299
DATA IS NOT TOO NOISY OR 

1602
01:04:55,299 --> 01:04:59,870
ARTIFACTUAL YOU HAVE TO TELL.

1603
01:04:59,870 --> 01:05:03,207
I'M MORE EXCITED WHEN IT'S 180° 

1604
01:05:03,207 --> 01:05:04,675
FROM WHAT I EXPECT.

1605
01:05:04,675 --> 01:05:07,177
I WAS WITH A GOOD GROUP AND WE 

1606
01:05:07,177 --> 01:05:08,979
SUPPORTED EACH OTHER AND DIDN'T 

1607
01:05:08,979 --> 01:05:11,115
BACK DOWN.

1608
01:05:11,115 --> 01:05:12,216
WE KEPT PUSHING FORWARD.

1609
01:05:12,216 --> 01:05:13,817
MOST OF THE TIME WHEN YOU LOOK 

1610
01:05:13,817 --> 01:05:15,619
BACK, LIKE I SEE A BUNCH OF 

1611
01:05:15,619 --> 01:05:16,487
OPPORTUNITIES I HAD THAT I 

1612
01:05:16,487 --> 01:05:17,688
DIDN'T TAKE.

1613
01:05:17,688 --> 01:05:19,557
LIKE A GUY WAS ASKING ME BRING 

1614
01:05:19,557 --> 01:05:21,492
SOME OF THAT GLP-1 DOWN AND 

1615
01:05:21,492 --> 01:05:23,761
I'LL USE IT IN MY FOOD INTAKE 

1616
01:05:23,761 --> 01:05:26,864
MODELS AND I NEVER GOT AROUND 

1617
01:05:26,864 --> 01:05:27,064
TO IT.

1618
01:05:27,064 --> 01:05:28,332
SOMEBODY ELSE DID THAT.

1619
01:05:28,332 --> 01:05:30,968
IT'S JUST THE WAY IT GOES.

1620
01:05:30,968 --> 01:05:31,869
>> Kimberly Narain: THANK
YOU 

1621
01:05:31,869 --> 01:05:32,336
SO MUCH FOR THAT.

1622
01:05:32,336 --> 01:05:33,904
>> David D'Alessio: YEAH, 

1623
01:05:33,904 --> 01:05:34,738
THANKS FOR ASKING.

1624
01:05:34,738 --> 01:05:36,173
>> Kimberly Narain: OKAY,
I 

1625
01:05:36,173 --> 01:05:39,376
THINK WE ARE GOING TO HEAD TO 

1626
01:05:39,376 --> 01:05:44,815
OUR NEXT PRESENTATION AT THIS 

1627
01:05:44,815 --> 01:05:54,925
POINT.

1628
01:05:56,393 --> 01:05:58,362
MR. MACIEJEWSKI, HE IS A 

1629
01:05:58,362 --> 01:05:59,930
RESEARCHER AT DUKE AS WELL.

1630
01:05:59,930 --> 01:06:01,665
HE IS REALLY A PIONEER WHEN IT 

1631
01:06:01,665 --> 01:06:04,835
COMES TO USING REAL-WORLD DATA 

1632
01:06:04,835 --> 01:06:05,069
SOURCES.

1633
01:06:05,069 --> 01:06:07,538
HE HAS E SINTLY LEVERAGED THE 

1634
01:06:07,538 --> 01:06:11,475
ENTIRE SPECTRUM OF REAL-WORLD 

1635
01:06:11,475 --> 01:06:13,277
DATA SOURCES AND ACTUALLY 

1636
01:06:13,277 --> 01:06:14,311
GENERATED SOME NEW ONES IN 

1637
01:06:14,311 --> 01:06:17,815
ORDER TO HELP US UNDERSTAND, 

1638
01:06:17,815 --> 01:06:19,249
ESSENTIALLY, THE ACCESS, THE 

1639
01:06:19,249 --> 01:06:22,186
COST, AND THE HEALTH 

1640
01:06:22,186 --> 01:06:24,054
IMPLICATIONS OF INTERVENTIONS 

1641
01:06:24,054 --> 01:06:27,291
FOR CARDIO METABOLIC DISEASE.

1642
01:06:27,291 --> 01:06:29,660
HE HAS STUDIED AN ARRAY OF 

1643
01:06:29,660 --> 01:06:31,729
INTERVENTIONS INCLUDING BUT NOT 

1644
01:06:31,729 --> 01:06:42,206
LIMITED TO BARE  BARIATRIC 

1645
01:06:42,973 --> 01:06:43,741
SURGERY.

1646
01:06:43,741 --> 01:06:45,609
HE IS THE ONE TO TALK TO US 

1647
01:06:45,609 --> 01:06:48,545
ABOUT THE LANDSCAPE OF 

1648
01:06:48,545 --> 01:06:50,214
REAL-WORLD AND BENEFITS AND 

1649
01:06:50,214 --> 01:06:51,882
TRADE-OFFS OF USING THESE 

1650
01:06:51,882 --> 01:06:53,517
DIFFERENT DATA SOURCES.

1651
01:06:53,517 --> 01:07:03,961
AND ABOUT METHODOLOGICAL.

1652
01:07:07,231 --> 01:07:08,666
TAKE IT AWAY, MR. MACIEJEWSKI.

1653
01:07:08,666 --> 01:07:09,400
>> Matthew Maciejewski:
THANK 

1654
01:07:09,400 --> 01:07:10,668
YOU VERY MUCH.

1655
01:07:10,668 --> 01:07:11,535
I APPRECIATE THE OPPORTUNITY TO 

1656
01:07:11,535 --> 01:07:12,970
PRESENT TO YOU ALL TODAY.

1657
01:07:12,970 --> 01:07:16,373
I WILL PROVIDE AN OVERVIEW OF 

1658
01:07:16,373 --> 01:07:18,342
TOPICS THAT WILL BE DISCUSSED 

1659
01:07:18,342 --> 01:07:20,811
IN GREATER DEPTH LATER TODAY 

1660
01:07:20,811 --> 01:07:31,055
AND TOMORROW.

1661
01:07:32,756 --> 01:07:35,192
I CAN SHARE MY OWN SLIDES IF 

1662
01:07:35,192 --> 01:07:36,360
NOBODY IS GOING TO BE PUTTING 

1663
01:07:36,360 --> 01:07:37,628
THEM UP.

1664
01:07:37,628 --> 01:07:39,296
HOPEFULLY YOU CAN SEE MY SLIDES.

1665
01:07:39,296 --> 01:07:43,567
SO I WANT TO DISCLOSE, MY 

1666
01:07:43,567 --> 01:07:43,867
DISCLOSURES.

1667
01:07:43,867 --> 01:07:45,069
HERE IS WHERE WE ARE GOING.

1668
01:07:45,069 --> 01:07:47,371
WE WILL SORT OF DESCRIBE REAL 

1669
01:07:47,371 --> 01:07:49,273
WORLD EVIDENCE AND REAL WORLD 

1670
01:07:49,273 --> 01:07:52,509
DATA AND TALK ABOUT THE DATA 

1671
01:07:52,509 --> 01:07:53,811
PUZZLES AND DATA TYPES TO 

1672
01:07:53,811 --> 01:07:55,412
GENERATE THAT EVIDENCE.

1673
01:07:55,412 --> 01:07:57,247
AND CONCLUDE WITH ISSUES ON THE 

1674
01:07:57,247 --> 01:07:59,483
VARIOUS STUDY DESIGNS WE MIGHT 

1675
01:07:59,483 --> 01:08:01,351
BRING TO BEAR TO ADDRESS 

1676
01:08:01,351 --> 01:08:02,052
IMPORTANT QUESTIONS IN THIS 

1677
01:08:02,052 --> 01:08:04,455
SPACE.

1678
01:08:04,455 --> 01:08:07,091
REAL-WORLD DATA, IF YOU ARE NOT 

1679
01:08:07,091 --> 01:08:09,793
AWARE, IS DATA AROUND PATIENT 

1680
01:08:09,793 --> 01:08:11,662
HEALTH STATUS IN THE DELIVERY 

1681
01:08:11,662 --> 01:08:14,732
OF CARE THAT IS ROUTINELY 

1682
01:08:14,732 --> 01:08:14,998
COLLECTED.

1683
01:08:14,998 --> 01:08:17,501
LEVERAGING DATA FROM EHR'S 

1684
01:08:17,501 --> 01:08:19,536
REGISTRIES AND CLAIMS, 

1685
01:08:19,536 --> 01:08:19,803
BASICALLY.

1686
01:08:19,803 --> 01:08:20,971
REAL WORLD EVIDENCE IS EVIDENCE 

1687
01:08:20,971 --> 01:08:23,040
ABOUT THE USAGE AND POTENTIAL 

1688
01:08:23,040 --> 01:08:25,743
BENEFITS OR RISKS OF MEDICAL 

1689
01:08:25,743 --> 01:08:28,378
PRODUCTS AND SERVICES DERIVED 

1690
01:08:28,378 --> 01:08:33,784
FROM THIS REAL-WORLD DATA.

1691
01:08:33,784 --> 01:08:35,853
AND TO FILL GAPS WE WILL HAVE 

1692
01:08:35,853 --> 01:08:39,356
TO LEVERAGE A FULL SPECTRUM OF 

1693
01:08:39,356 --> 01:08:40,991
DESIGNS I WILL TALK ABOUT.

1694
01:08:40,991 --> 01:08:43,293
IN THE IDEAL WORLD THE DATA 

1695
01:08:43,293 --> 01:08:45,996
AVAILABLE TO US FOR GLP-1 

1696
01:08:45,996 --> 01:08:48,265
EVALUATION WOULD BE DATA THAT 

1697
01:08:48,265 --> 01:08:50,334
IS ROUTINELY AVAILABLE, THE 

1698
01:08:50,334 --> 01:08:52,636
REAL-WORLD DATA IN BLACK HERE.

1699
01:08:52,636 --> 01:08:54,772
AND IDEAL DATA THAT IS RARELY 

1700
01:08:54,772 --> 01:08:56,740
AVAILABLE IN THE RED.

1701
01:08:56,740 --> 01:09:01,044
SO NOT ONLY WOULD WE HAVE THE 

1702
01:09:01,044 --> 01:09:02,679
ANTI-OBESITY MEDICATION OR AOM 

1703
01:09:02,679 --> 01:09:04,348
ORDERS AND FILLS BUT WE WOULD 

1704
01:09:04,348 --> 01:09:07,684
ALSO HAVE INFORMATION ON THE 

1705
01:09:07,684 --> 01:09:09,586
COMPOUNDED INFORMATION THAT WE 

1706
01:09:09,586 --> 01:09:11,488
KNOW PATIENTS ARE GETTING THEM, 

1707
01:09:11,488 --> 01:09:14,424
WE JUST DON'T KNOW TO WHAT 

1708
01:09:14,424 --> 01:09:14,658
EXTENT.

1709
01:09:14,658 --> 01:09:17,528
WE WOULD IDEALLY HAVE NOTES 

1710
01:09:17,528 --> 01:09:20,130
FROM EVERY CLINIC VISIT THAT IS 

1711
01:09:20,130 --> 01:09:21,765
INCREASINGLY AVAILABLE.

1712
01:09:21,765 --> 01:09:23,433
INFORMATION ON HEALTH SYSTEM 

1713
01:09:23,433 --> 01:09:24,001
AND PATIENT BEHAVIOR 

1714
01:09:24,001 --> 01:09:26,303
INFORMATION IN THE BOTTOM PART 

1715
01:09:26,303 --> 01:09:27,938
OF THE RED TEXT.

1716
01:09:27,938 --> 01:09:30,040
HAVING THIS ADDITIONAL DATA IN 

1717
01:09:30,040 --> 01:09:32,976
RED WOULD HELP US ENRICH OUR 

1718
01:09:32,976 --> 01:09:34,645
ABILITY TO CHARACTERIZE 

1719
01:09:34,645 --> 01:09:36,814
INCLUSION AND EXCLUSION 

1720
01:09:36,814 --> 01:09:38,582
CRITERIA.

1721
01:09:38,582 --> 01:09:40,450
CO-VARIANTS FOR PREDESCRIPTIVE 

1722
01:09:40,450 --> 01:09:40,918
PURPOSES, REGRESSION 

1723
01:09:40,918 --> 01:09:42,986
ADJUSTMENTS AND TO BE ABLE TO 

1724
01:09:42,986 --> 01:09:44,454
ADDRESS COMPETING HYPOTHESES 

1725
01:09:44,454 --> 01:09:46,356
FOR WHY WE ARE SEEING OUTCOMES 

1726
01:09:46,356 --> 01:09:48,458
IF WE KNEW OF PEOPLE'S USE OF 

1727
01:09:48,458 --> 01:09:52,563
GYMS AND POOLS AND SUCH AND 

1728
01:09:52,563 --> 01:09:54,832
RIDING BIKES AND WOULD HELP US 

1729
01:09:54,832 --> 01:09:57,000
ENRICH OUR OUTCOME MEASUREMENT.

1730
01:09:57,000 --> 01:10:00,103
THERE IS A BROAD ARRAY OF 

1731
01:10:00,103 --> 01:10:01,171
STRUCTURED AND UNSTRUCTURED 

1732
01:10:01,171 --> 01:10:04,474
DATA THAT MIGHT BE USEFUL IN A 

1733
01:10:04,474 --> 01:10:06,343
BIG DATA WORLD.

1734
01:10:06,343 --> 01:10:08,846
THIS IS CHARACTERIZED NICELY IN 

1735
01:10:08,846 --> 01:10:11,982
THIS NICE 2014 PAPER IN JAMA 

1736
01:10:11,982 --> 01:10:14,051
THAT WOULD CAPTURE AN ARRAY OF 

1737
01:10:14,051 --> 01:10:15,919
DOMAINS OR TYPES OF DATA IN THE 

1738
01:10:15,919 --> 01:10:17,821
ROWS HERE ON THE LEFT.

1739
01:10:17,821 --> 01:10:20,791
SOME OF WHICH I WILL DESCRIBE 

1740
01:10:20,791 --> 01:10:21,592
NOW.

1741
01:10:21,592 --> 01:10:23,594
EHR DATA IS ROUTINELY AVAILABLE 

1742
01:10:23,594 --> 01:10:25,896
IN A NUMBER OF DOMAINS.

1743
01:10:25,896 --> 01:10:28,198
THOSE THAT ARE AVAILABLE ACROSS 

1744
01:10:28,198 --> 01:10:30,234
ALL THE HR'S MORE OR LESS, IS 

1745
01:10:30,234 --> 01:10:32,336
REPRESENTED BY THE GREEN X'S, 

1746
01:10:32,336 --> 01:10:35,072
AND THOSE THAT ARE SOMETIMES 

1747
01:10:35,072 --> 01:10:38,141
AVAILABLE IN SOME EHR'S AND NOT 

1748
01:10:38,141 --> 01:10:40,844
OTHERS ARE YELLOW, LIKE 

1749
01:10:40,844 --> 01:10:42,279
SOCIOECONOMIC STATUS, MORTALITY 

1750
01:10:42,279 --> 01:10:44,314
OR HEALTH BENEFITS.

1751
01:10:44,314 --> 01:10:46,183
EHR'S HAVE A NUMBER OF 

1752
01:10:46,183 --> 01:10:48,252
LIMITATIONS, HOWEVER, DUE TO 

1753
01:10:48,252 --> 01:10:51,021
THEIR LACK OF INTEROPERABILITY.

1754
01:10:51,021 --> 01:10:53,090
SUPPOSE I'M HERE IN NORTH 

1755
01:10:53,090 --> 01:10:55,092
CAROLINA IN THE TRIANGLE.

1756
01:10:55,092 --> 01:10:57,661
SAY THERE'S TWO PAYERS, 

1757
01:10:57,661 --> 01:10:59,730
MEDICARE IS PAYER ONE, BLUE 

1758
01:10:59,730 --> 01:11:02,266
CROSS, BLUE SHIELD OF NORTH 

1759
01:11:02,266 --> 01:11:04,935
CAROLINA IS PAYER TWO.

1760
01:11:04,935 --> 01:11:06,603
OVER TIME, PATIENTS WILL BE 

1761
01:11:06,603 --> 01:11:08,071
COVERED BY DIFFERENT PAYERS.

1762
01:11:08,071 --> 01:11:10,741
AND DUE TO THE PROVIDER 

1763
01:11:10,741 --> 01:11:13,644
NETWORKS ALLOWED IN THOSE 

1764
01:11:13,644 --> 01:11:15,512
DIFFERENT PAYERS PATIENTS MAY 

1765
01:11:15,512 --> 01:11:17,114
APPEAR, DISAPPEAR AND REAPPEAR 

1766
01:11:17,114 --> 01:11:20,517
IN DIFFERENT OUTPATIENT AND 

1767
01:11:20,517 --> 01:11:22,319
INPATIENT EHR'S.

1768
01:11:22,319 --> 01:11:26,690
THE DUKE EHR OUTPATIENT EHR A 

1769
01:11:26,690 --> 01:11:32,796
AND B, AND UNC OUTPATIENT AND 

1770
01:11:32,796 --> 01:11:35,032
EHR C AND D OVER TIME.

1771
01:11:35,032 --> 01:11:37,234
THERE ARE SOME HEALTH SYSTEMS 

1772
01:11:37,234 --> 01:11:39,136
THAT ARE FAIRLY UNIQUE BECAUSE 

1773
01:11:39,136 --> 01:11:40,804
THEY ARE RELATIVELY CLOSED 

1774
01:11:40,804 --> 01:11:41,405
SYSTEMS.

1775
01:11:41,405 --> 01:11:43,974
AND NOT ONLY A PAYER BUT ALSO 

1776
01:11:43,974 --> 01:11:46,877
THE PROVIDER OF CARE, LIKE V.A. 

1777
01:11:46,877 --> 01:11:48,512
AND KAISER PERMANENTE WHERE YOU 

1778
01:11:48,512 --> 01:11:50,480
MAY HAVE PERFECT OVERLAP OF THE 

1779
01:11:50,480 --> 01:11:52,916
PAYER CLAIMS IN THE YELLOW 

1780
01:11:52,916 --> 01:11:54,751
CIRCLES AND EHR'S IN THE GREEN 

1781
01:11:54,751 --> 01:11:56,586
AND BLUE CIRCLES THAT 

1782
01:11:56,586 --> 01:11:58,455
COMPLETELY OVERLAP BECAUSE THEY 

1783
01:11:58,455 --> 01:12:01,959
ARE ENTIRELY CLOSED SYSTEMS AND 

1784
01:12:01,959 --> 01:12:04,161
PAYERS AND PROVIDERS OF CARE.

1785
01:12:04,161 --> 01:12:05,696
OTHERWISE IN MOST COMMERCIAL 

1786
01:12:05,696 --> 01:12:07,531
INSURANCE, THERE'S LOTS OF 

1787
01:12:07,531 --> 01:12:10,000
TURNOVER, SO PEOPLE ARE 

1788
01:12:10,000 --> 01:12:11,601
APPEARING AND DISAPPEARING AND 

1789
01:12:11,601 --> 01:12:13,270
REAPPEARING IN THESE DIFFERENT 

1790
01:12:13,270 --> 01:12:14,905
SOURCES OF DATA BECAUSE THEY 

1791
01:12:14,905 --> 01:12:16,773
ARE CHANGING INSURANCE COVERAGE 

1792
01:12:16,773 --> 01:12:18,008
AND CHANGING THEIR USUAL 

1793
01:12:18,008 --> 01:12:20,077
PROVIDER OF CARE THAT MAY BE 

1794
01:12:20,077 --> 01:12:22,579
DRIVING WHICH SYSTEMS AND EHR'S 

1795
01:12:22,579 --> 01:12:23,380
THEY APPEAR IN.

1796
01:12:23,380 --> 01:12:25,882
SO THEY MAY BE BOUNCING BETWEEN 

1797
01:12:25,882 --> 01:12:29,219
SAY DUKE AND UNC.

1798
01:12:29,219 --> 01:12:31,521
AND THIS APPEARING REAPPEARING 

1799
01:12:31,521 --> 01:12:32,956
PHENOMENON PROBABLY OCCURS IN 

1800
01:12:32,956 --> 01:12:36,093
OTHER HEALTH CARE SYSTEMS 

1801
01:12:36,093 --> 01:12:39,997
DEPENDING ON THE SYSTEMS 

1802
01:12:39,997 --> 01:12:40,263
OPERATING.

1803
01:12:40,263 --> 01:12:41,732
EHR'S HAVE OTHER LIMITATIONS, 

1804
01:12:41,732 --> 01:12:42,933
INCLUDING CLINICAL NOTES MAY 

1805
01:12:42,933 --> 01:12:45,435
NOT BE AVAILABLE.

1806
01:12:45,435 --> 01:12:48,138
WITH NLP CHANGING, BUT THEY ARE 

1807
01:12:48,138 --> 01:12:50,040
NOT UNIFORMLY AVAILABLE.

1808
01:12:50,040 --> 01:12:52,209
UNSTRUCTURED DATA IS JUST 

1809
01:12:52,209 --> 01:12:53,944
INHERENTLY CHALLENGING.

1810
01:12:53,944 --> 01:12:56,413
EHR'S ARE OFTEN HIGHLY 

1811
01:12:56,413 --> 01:12:58,315
CUSTOMIZED WHILE UNC AND DUKE 

1812
01:12:58,315 --> 01:13:00,183
MAY HAVE COMMON DOMAINS THERE 

1813
01:13:00,183 --> 01:13:04,287
MAY BE DOMAINS AVAILABLE IN THE 

1814
01:13:04,287 --> 01:13:06,790
DUKE EHR NOT AVAILABLE IN THE 

1815
01:13:06,790 --> 01:13:10,560
UNC, AND REVERSE, THERE MAY BE 

1816
01:13:10,560 --> 01:13:12,929
DOMAINS AVAILABLE IN UNC NOT IN 

1817
01:13:12,929 --> 01:13:15,932
THE DUKE.

1818
01:13:15,932 --> 01:13:18,035
IF A PATIENT WENT TO UNC 

1819
01:13:18,035 --> 01:13:20,103
YESTERDAY AND DUKE TODAY, THERE 

1820
01:13:20,103 --> 01:13:22,406
MAY BE DIFFERENT VALUES OF 

1821
01:13:22,406 --> 01:13:24,875
BLOOD PRESSURE FOR PERFECTLY 

1822
01:13:24,875 --> 01:13:26,576
REASONABLE REASONS, BLOOD PRESS 

1823
01:13:26,576 --> 01:13:29,246
YOUS CAN CHANGE HOUR TO HOUR, 

1824
01:13:29,246 --> 01:13:32,649
BUT THERE MAY BE TYPOS THAT MAY 

1825
01:13:32,649 --> 01:13:34,284
CAUSE DATA THAT SHOULD BE 

1826
01:13:34,284 --> 01:13:36,119
SIMILAR TO APPEAR DIFFERENTLY.

1827
01:13:36,119 --> 01:13:37,154
PRAF PRAFT

1828
01:13:37,154 --> 01:13:40,891
THE LACK OF INTEROPERABILITY 

1829
01:13:40,891 --> 01:13:44,895
MAY RESULT IN COUNTING OF 

1830
01:13:44,895 --> 01:13:49,266
COVARIATES.

1831
01:13:49,266 --> 01:13:59,743
COLLEAGUE AT DUKE, BHAVSAR.

1832
01:14:03,480 --> 01:14:06,383
WHETHER YOU RELY ON DATA FROM A 

1833
01:14:06,383 --> 01:14:08,652
SINGLE EHR OR POOL ACROSS 

1834
01:14:08,652 --> 01:14:10,087
DIFFERENT EHR'S YOU COULD SEE 

1835
01:14:10,087 --> 01:14:12,189
THE PREVALENCE OF HYPERTENSION 

1836
01:14:12,189 --> 01:14:13,857
IS SIGNIFICANTLY UNDER COUNTED 

1837
01:14:13,857 --> 01:14:16,293
IF JUST RELYING ON A SINGLE 

1838
01:14:16,293 --> 01:14:18,995
EHR, COMPARED TO CHARACTERIZING 

1839
01:14:18,995 --> 01:14:26,236
HYPERTENSION DIAGNOSE  

1840
01:14:26,236 --> 01:14:29,372
DIAGNOSES ON ALL THREE.

1841
01:14:29,372 --> 01:14:32,509
THE INCIDENTS OF THESE 

1842
01:14:32,509 --> 01:14:33,143
IMPORTANT CARDIOVASCULAR 

1843
01:14:33,143 --> 01:14:35,212
OUTCOMES IS SIGNIFICANTLY UNDER 

1844
01:14:35,212 --> 01:14:39,483
COUNTED IN A SINGLE EHR.

1845
01:14:39,483 --> 01:14:42,352
SO FOR EXAMPLE, USING AT 

1846
01:14:42,352 --> 01:14:46,323
COMPOSITE STROKE AND HEART A 

1847
01:14:46,323 --> 01:14:48,592
FAILURE, THERE'S ALMOST 

1848
01:14:48,592 --> 01:14:50,494
UNDERCOUNT OF 6.4% COMPARED TO 

1849
01:14:50,494 --> 01:14:53,430
WHEN YOU TRACK THAT ACROSS ALL 

1850
01:14:53,430 --> 01:14:55,932
EHR'S UP TO 9%.

1851
01:14:55,932 --> 01:14:58,001
THERE ARE NETWORKS NOW OF 

1852
01:14:58,001 --> 01:15:01,138
REAL-WORLD DATA THAT HAVE BEEN 

1853
01:15:01,138 --> 01:15:04,708
COMPILED IN FEDERATED FORMS AN 

1854
01:15:04,708 --> 01:15:05,108
CENTRALIZED FORMS.

1855
01:15:05,108 --> 01:15:06,610
IN A CENTRALIZED NETWORK ALL 

1856
01:15:06,610 --> 01:15:08,945
THE DATA IS SORT OF BROUGHT TO 

1857
01:15:08,945 --> 01:15:11,181
A CENTRALIZED HUB AND DATA 

1858
01:15:11,181 --> 01:15:12,916
COULD BE LEVERAGED IN LARGE 

1859
01:15:12,916 --> 01:15:14,618
SAMPLES THAT WAY.

1860
01:15:14,618 --> 01:15:15,952
OR A FEDERATED VERSION WHERE 

1861
01:15:15,952 --> 01:15:18,355
THE DATA SITS IN EACH OF THE 

1862
01:15:18,355 --> 01:15:20,657
SYSTEM AND THERE'S DISTRIBUTED 

1863
01:15:20,657 --> 01:15:21,925
DATA ANALYSIS THAT'S DONE.

1864
01:15:21,925 --> 01:15:25,028
THIS SLIDE SHOWS ATTRIBUTES OF 

1865
01:15:25,028 --> 01:15:26,530
THESE DIFFERENT NETWORKS AND 

1866
01:15:26,530 --> 01:15:36,973
CONCRETE EXAMPLES OF THEM.

1867
01:15:50,587 --> 01:15:57,060
RINDISTRIES.

1868
01:15:57,060 --> 01:15:59,162
--  REGISTRIS.

1869
01:15:59,162 --> 01:16:02,866
IF THEY HAVE DIFFERENT EHR'S, 

1870
01:16:02,866 --> 01:16:13,343
UNDERLYING DATA STRUCTURES  

1871
01:16:15,645 --> 01:16:18,248
REGISTRIES ARE FOR PEOPLE WITH 

1872
01:16:18,248 --> 01:16:18,982
RARE CONDITION OR COMMON 

1873
01:16:18,982 --> 01:16:21,318
DISEASE.

1874
01:16:21,318 --> 01:16:22,619
OR CERTAIN PROCEDURES.

1875
01:16:22,619 --> 01:16:26,423
DUKE HAS BEEN INVOLVED IN 

1876
01:16:26,423 --> 01:16:28,925
COMPILATION OF NUMEROUS 

1877
01:16:28,925 --> 01:16:29,459
CARDIOVASCULAR PROCEDURE 

1878
01:16:29,459 --> 01:16:30,327
REGISTRIS.

1879
01:16:30,327 --> 01:16:32,829
SO REGISTRIES COULD POTENTIALLY 

1880
01:16:32,829 --> 01:16:35,332
BE USEFUL SOURCE FOR EVALUATION.

1881
01:16:35,332 --> 01:16:38,301
THEY SHARE COMMON DOMAINS OF 

1882
01:16:38,301 --> 01:16:40,103
EHR'S BUT THEY HAVE UNIQUE 

1883
01:16:40,103 --> 01:16:43,473
DOMAINS THAT MAY NOT BE IN THE 

1884
01:16:43,473 --> 01:16:45,575
EHR'S LIKE FOLLOW-UP TIMES 

1885
01:16:45,575 --> 01:16:47,711
SINCE CARDIOVASCULAR REGISTRIS 

1886
01:16:47,711 --> 01:16:49,946
ARE VERY INTERESTED IN 

1887
01:16:49,946 --> 01:16:50,580
UNDERSTANDING PATIENT OUTCOMES 

1888
01:16:50,580 --> 01:16:54,784
IN THE MEDIUM AND LONG TERMS.

1889
01:16:54,784 --> 01:16:56,853
SO CHARACTERIZING AT TIME 

1890
01:16:56,853 --> 01:16:59,022
POINTS IS IMPORTANT IN 

1891
01:16:59,022 --> 01:16:59,289
REGISTRIS.

1892
01:16:59,289 --> 01:17:03,727
AND THEN THERE'S CLAIMS DATA, 

1893
01:17:03,727 --> 01:17:05,862
MEDICARE OR OTHER, THAT HAVE 

1894
01:17:05,862 --> 01:17:08,365
DOMAINS SIMILAR FROM EHR'S AND 

1895
01:17:08,365 --> 01:17:10,166
REGISTRIES BUT ALSO HAVE UNIQUE 

1896
01:17:10,166 --> 01:17:11,268
DATA ELEMENTS.

1897
01:17:11,268 --> 01:17:14,337
LIKE PAYMENTS AND REIMBURSEMENT.

1898
01:17:14,337 --> 01:17:17,040
SO IN MEDICARE CLAIMS YOU KNOW 

1899
01:17:17,040 --> 01:17:20,343
WHAT MEDICARE HAS PAID FOR EACH 

1900
01:17:20,343 --> 01:17:22,012
VISIT, EACH MEDICATION, EACH 

1901
01:17:22,012 --> 01:17:23,680
HOSPITALIZATION AND YOU ALSO 

1902
01:17:23,680 --> 01:17:25,548
KNOW ENROLLMENT BECAUSE THE 

1903
01:17:25,548 --> 01:17:28,018
DATA CONTAINED IS ONLY ON THOSE 

1904
01:17:28,018 --> 01:17:29,119
COULD HAVED BY THE PARTICULAR 

1905
01:17:29,119 --> 01:17:30,920
PAYER.

1906
01:17:30,920 --> 01:17:34,658
SO CLAIMS DATA HAD PARTICULAR 

1907
01:17:34,658 --> 01:17:35,525
BENEFITS IT'S CHARACTERIZING 

1908
01:17:35,525 --> 01:17:38,395
THE CARE THAT'S BEEN REIMBURSED 

1909
01:17:38,395 --> 01:17:41,097
WITHIN A PARTICULAR REGION, 

1910
01:17:41,097 --> 01:17:46,236
SUCH AS KAISER PERMANENTE, 

1911
01:17:46,236 --> 01:17:49,973
WASHINGTON WHERE DAVID 

1912
01:17:49,973 --> 01:17:50,940
ARTERBURN IS, OR DUKE OR 

1913
01:17:50,940 --> 01:17:52,876
MEDICARE.

1914
01:17:52,876 --> 01:17:54,711
BUT IT'S AGAIN LIMITED.

1915
01:17:54,711 --> 01:18:03,453
IT ONLY INCLUDES PEOPLE WHO ARE 

1916
01:18:03,453 --> 01:18:06,089
COVERED BY THAT PAYER.

1917
01:18:06,089 --> 01:18:10,293
IF YOU ARE INTERESTED IN 

1918
01:18:10,293 --> 01:18:11,528
UNDERSTANDING GLP-1 USE IN 

1919
01:18:11,528 --> 01:18:12,996
MEDICAID THERE'S ONLY A CERTAIN 

1920
01:18:12,996 --> 01:18:14,531
NUMBER OF STATES, MAYBE TEN 

1921
01:18:14,531 --> 01:18:17,567
RIGHT NOW THAT COVER GLP-1'S.

1922
01:18:17,567 --> 01:18:21,538
IF ARE IN A STATE LIKE NORTH 

1923
01:18:21,538 --> 01:18:22,772
CAROLINA WHERE MEDICAID DOESN'T 

1924
01:18:22,772 --> 01:18:23,807
COVER, WON'T HAVE THAT 

1925
01:18:23,807 --> 01:18:24,708
INFORMATION.

1926
01:18:24,708 --> 01:18:27,844
NONE OF THE CLAIMS DATA HAVE 

1927
01:18:27,844 --> 01:18:28,912
INFORMATION ON COMPOUNDED 

1928
01:18:28,912 --> 01:18:30,513
GLP-1'S.

1929
01:18:30,513 --> 01:18:31,815
SO THAT CHARACTERIZES A RANGE 

1930
01:18:31,815 --> 01:18:33,883
AT A HIGH LEVEL OF DATA SOURCES 

1931
01:18:33,883 --> 01:18:36,686
THAT MIGHT BE AVAILABLE FOR 

1932
01:18:36,686 --> 01:18:37,587
GLP-1 EVALUATION.

1933
01:18:37,587 --> 01:18:40,323
NOW WE WILL PIVOT TO STUDY 

1934
01:18:40,323 --> 01:18:41,991
DESIGNS THAT MIGHT LEVERAGE 

1935
01:18:41,991 --> 01:18:44,327
THESE DATA TO BE ABLE TO 

1936
01:18:44,327 --> 01:18:46,930
PROVIDE OR GENERATE REAL-WORLD 

1937
01:18:46,930 --> 01:18:47,197
EVIDENCE.

1938
01:18:47,197 --> 01:18:48,264
THERE'S THREE BASIC DESIGNS I 

1939
01:18:48,264 --> 01:18:52,135
WILL TALK ABOUT.

1940
01:18:52,135 --> 01:18:52,736
HIGHLY-CONTROLLED RANDOMIZED 

1941
01:18:52,736 --> 01:18:55,705
TRIAL.

1942
01:18:55,705 --> 01:18:56,940
PRAGMATIC, AND QUASI 

1943
01:18:56,940 --> 01:18:59,676
EXPERIMENTAL STUDY THAT COULD 

1944
01:18:59,676 --> 01:19:01,311
EMULATE TRIALS USING TARGET 

1945
01:19:01,311 --> 01:19:02,212
TRIAL PRINCIPLES.

1946
01:19:02,212 --> 01:19:04,514
IF YOU ARE INTERESTED IN 

1947
01:19:04,514 --> 01:19:06,383
PRAGMATIC TRIAL METHODS AND 

1948
01:19:06,383 --> 01:19:10,286
ISSUES I RECOMMEND YOU STICK 

1949
01:19:10,286 --> 01:19:12,722
AROUND FOR ANJA'S AND LESLIE'S 

1950
01:19:12,722 --> 01:19:13,423
TALK LATER.

1951
01:19:13,423 --> 01:19:18,995
IF YOU ARE INTERESTED IN THE 

1952
01:19:18,995 --> 01:19:23,633
OTHER WORK, MIGUEL HERNAN, I 

1953
01:19:23,633 --> 01:19:25,535
RECOMMEND YOU STICK AROUND FOR 

1954
01:19:25,535 --> 01:19:28,872
HIS TALK LATER TODAY.

1955
01:19:28,872 --> 01:19:30,140
FUNDAMENTAL ISSUE REGARDLESS OF 

1956
01:19:30,140 --> 01:19:36,980
THE STUDY DESIGN IS WHAT 

1957
01:19:36,980 --> 01:19:40,917
COMPARITOR ARE YOU GOING TO BE 

1958
01:19:40,917 --> 01:19:41,151
USING.

1959
01:19:41,151 --> 01:19:47,991
ANOTHER MEDICATION, OR ACTIVE 

1960
01:19:47,991 --> 01:19:55,064
NON ANTI-OBESITY MEDICATION, 

1961
01:19:55,064 --> 01:19:58,635
SGLT-2 OR DPP-4I.

1962
01:19:58,635 --> 01:20:00,770
OR BARIATRIC SURGERY OR CPAP OR 

1963
01:20:00,770 --> 01:20:02,772
USUAL CARE.

1964
01:20:02,772 --> 01:20:05,275
IT AFFECTS THE CONFOUNDING THAT 

1965
01:20:05,275 --> 01:20:08,812
MIGHT BE RELEVANT IN YOUR 

1966
01:20:08,812 --> 01:20:09,279
NON-RANDOMIZED STUDY.

1967
01:20:09,279 --> 01:20:10,480
AND WHAT PARTICULAR SOURCE OF 

1968
01:20:10,480 --> 01:20:11,681
CONFOUNDING THAT MIGHT BE 

1969
01:20:11,681 --> 01:20:13,583
IMPORTANT.

1970
01:20:13,583 --> 01:20:16,519
FOR EXAMPLE, IF WE WANT TO DO A 

1971
01:20:16,519 --> 01:20:20,890
STUDY COMPARING SEMAGLUTIDE TO 

1972
01:20:20,890 --> 01:20:22,759
TIRZEPATIDE, YOU KNOW, THE 

1973
01:20:22,759 --> 01:20:25,328
DEGREE OF CONFOUNDING IS 

1974
01:20:25,328 --> 01:20:26,129
PROBABLY RELATIVELY UNIFORM 

1975
01:20:26,129 --> 01:20:29,232
BECAUSE THESE ARE TWO COHORTS 

1976
01:20:29,232 --> 01:20:31,901
OF PATIENTS WHO ARE ACTIVELY 

1977
01:20:31,901 --> 01:20:33,736
SEEKING TREATMENT FOR WEIGHT 

1978
01:20:33,736 --> 01:20:36,306
LOSS, PRESUMABLY.

1979
01:20:36,306 --> 01:20:41,544
AND THEY ARE EQUALLY OPEN TO 

1980
01:20:41,544 --> 01:20:43,279
SIMILAR MODES OF RECEIVING THAT 

1981
01:20:43,279 --> 01:20:44,681
TREATMENT.

1982
01:20:44,681 --> 01:20:46,549
WHEREAS, IF YOU ARE DOING 

1983
01:20:46,549 --> 01:20:49,619
COMPARISON OF PATIENTS WHO ARE 

1984
01:20:49,619 --> 01:20:50,487
HAVING SEMAGLUTIDE VERSUS 

1985
01:20:50,487 --> 01:20:52,055
PEOPLE GETTING BARIATRIC 

1986
01:20:52,055 --> 01:20:53,923
SURGERY, YOU ARE GOING TO BE 

1987
01:20:53,923 --> 01:20:55,959
COMPARING PEOPLE WHO ARE ALSO 

1988
01:20:55,959 --> 01:20:57,660
SEEKING WEIGHT LOSS TREATMENT 

1989
01:20:57,660 --> 01:20:59,329
BUT MAYBE THERE'S DIFFERENCE IN 

1990
01:20:59,329 --> 01:21:00,830
WILLINGNESS TO INJECT 

1991
01:21:00,830 --> 01:21:07,470
MEDICATION.

1992
01:21:07,470 --> 01:21:09,372
AND DIFFERENT OPENNESS.

1993
01:21:09,372 --> 01:21:14,110
VERSUS SAY A COMPARISON OF 

1994
01:21:14,110 --> 01:21:15,712
SEMAGLUTIDE TO SGLT-2'S, MAY BE 

1995
01:21:15,712 --> 01:21:20,049
THE PATIENTS RECEIVING SGLT-2'S 

1996
01:21:20,049 --> 01:21:21,484
AREN'T ACTIVELY SEEKING WEIGHT 

1997
01:21:21,484 --> 01:21:22,752
LOSS TREATMENT, THEY ARE 

1998
01:21:22,752 --> 01:21:25,255
SEEKING TREATMENT FOR MANAGING 

1999
01:21:25,255 --> 01:21:27,590
OF THEIR DIABETES, WHEREAS 

2000
01:21:27,590 --> 01:21:29,092
PEOPLE RECEIVING SEMAGLUTIDE 

2001
01:21:29,092 --> 01:21:30,393
ARE INTERESTED IN THE WEIGHT 

2002
01:21:30,393 --> 01:21:31,728
LOSS BENEFITS.

2003
01:21:31,728 --> 01:21:32,729
THE SECOND IMPLICATION WHICH 

2004
01:21:32,729 --> 01:21:34,664
MAY BE SUPER OBVIOUS, THE 

2005
01:21:34,664 --> 01:21:36,032
RESEARCH QUESTION AND CLINICAL 

2006
01:21:36,032 --> 01:21:37,934
DECISION MAKING YOU ARE TRYING 

2007
01:21:37,934 --> 01:21:41,538
TO INFORM CHANGES AS THE 

2008
01:21:41,538 --> 01:21:42,505
COMPARATOR CHANGES.

2009
01:21:42,505 --> 01:21:46,276
IF YOU ARE COMPARING THE 

2010
01:21:46,276 --> 01:21:47,510
SEMAGLUTIDE AND TIRZEPATIDE YOU 

2011
01:21:47,510 --> 01:21:49,779
ARE TRYING TO INFORM THE 

2012
01:21:49,779 --> 01:21:52,048
CLINICAL DECISION, WHICH GLP-1 

2013
01:21:52,048 --> 01:21:54,584
SHOULD A GIVEN PROVIDER PROVIDE 

2014
01:21:54,584 --> 01:21:56,252
CONSIDER PROVIDING AND WHAT ARE 

2015
01:21:56,252 --> 01:21:58,855
THE TRADE-OFFS OF THAT.

2016
01:21:58,855 --> 01:22:00,390
COMPARED TO DECISION MAKING 

2017
01:22:00,390 --> 01:22:05,895
AROUND PHARMACOTHERAPY VERSUS 

2018
01:22:05,895 --> 01:22:06,162
SURGERY.

2019
01:22:06,162 --> 01:22:08,164
IF YOU WANT TO HEAR A LOT MORE 

2020
01:22:08,164 --> 01:22:11,701
ABOUT THIS, I SUGGEST YOU STICK 

2021
01:22:11,701 --> 01:22:13,336
AROUND FOR KRISTINA LEWIS'S 

2022
01:22:13,336 --> 01:22:14,671
TALK TOMORROW.

2023
01:22:14,671 --> 01:22:17,006
AND THEN LET ME NOW TURN TO AN 

2024
01:22:17,006 --> 01:22:18,875
ILLUSTRATION OF THE POTENTIAL 

2025
01:22:18,875 --> 01:22:21,344
VALUE IN SAMPLE RESTRICTION 

2026
01:22:21,344 --> 01:22:24,280
WHEN THINKING ABOUT MEDICATION 

2027
01:22:24,280 --> 01:22:26,649
EVALUATION AND IT'S EFFECTS ON 

2028
01:22:26,649 --> 01:22:27,383
CLINICAL OUTCOMES.

2029
01:22:27,383 --> 01:22:29,886
IN THIS CASE MORTAL.

2030
01:22:29,886 --> 01:22:31,955
ITY.

2031
01:22:31,955 --> 01:22:36,960
BASED ON 2007 PAPER BY 

2032
01:22:36,960 --> 01:22:39,662
SEBASTIAN KNEE WISE, USE OF 

2033
01:22:39,662 --> 01:22:41,764
STATIN IN ONE-YEAR MORTALITY, 

2034
01:22:41,764 --> 01:22:44,467
OLDER ADULTS IN PENNSYLVANIA.

2035
01:22:44,467 --> 01:22:47,203
THEY RECOGNIZED THAT THE CHOICE 

2036
01:22:47,203 --> 01:22:49,706
OF COMPARATOR CAN FUNDAMENTALLY 

2037
01:22:49,706 --> 01:22:51,841
CHANGE YOUR ESTIMATED RATE 

2038
01:22:51,841 --> 01:22:53,343
RATIO SHOWN IN THE RED AND 

2039
01:22:53,343 --> 01:22:56,779
BLACK TEXT TO THE RIGHT.

2040
01:22:56,779 --> 01:22:59,315
AND THAT THERE MAY BE VALUE IN 

2041
01:22:59,315 --> 01:23:02,385
TRYING TO, THROUGH STUDY DESIGN 

2042
01:23:02,385 --> 01:23:04,220
AND SAMPLE RESTRICTION, IMPROVE 

2043
01:23:04,220 --> 01:23:09,058
THE INTERNAL VALIDITY BY 

2044
01:23:09,058 --> 01:23:10,226
REDUCING CONFOUNDING IN YOUR 

2045
01:23:10,226 --> 01:23:13,029
CHOICE OF COMPARATOR.

2046
01:23:13,029 --> 01:23:14,297
INITIALLY IN THE FIRST LINE 

2047
01:23:14,297 --> 01:23:18,301
THEY WERE COMPARING STATIN 

2048
01:23:18,301 --> 01:23:21,971
USERS AND NON-USERS.

2049
01:23:21,971 --> 01:23:23,139
IN LARGE COHORTS.

2050
01:23:23,139 --> 01:23:25,975
BUT THEY WERE WORRIED THAT THE 

2051
01:23:25,975 --> 01:23:30,580
NON-USERS HAD A HETEROGENEOUS 

2052
01:23:30,580 --> 01:23:33,116
GROUP OF NON-USERS ALL ELIGIBLE 

2053
01:23:33,116 --> 01:23:36,819
FOR STATINS BUT QUITE VARIED IN 

2054
01:23:36,819 --> 01:23:38,588
THEIR SOURCE OF CONFOUNDING.

2055
01:23:38,588 --> 01:23:41,391
SO THEY WANTED TO REDUCE THE 

2056
01:23:41,391 --> 01:23:42,325
SOURCE OF CONFOUNDING WHICH 

2057
01:23:42,325 --> 01:23:44,827
WERE QUITE DIFFUSE THROUGH 

2058
01:23:44,827 --> 01:23:45,261
SAMPLE RESTRICTION.

2059
01:23:45,261 --> 01:23:47,296
YOU COULD SEE HOW THE SAMPLE 

2060
01:23:47,296 --> 01:23:51,300
SIZES DROPPED AS THEY IMPOSE 

2061
01:23:51,300 --> 01:23:51,801
ADDITIONAL RESTRICTIONS.

2062
01:23:51,801 --> 01:23:54,504
TO MAKE THEM MORE HOMOGENOUS 

2063
01:23:54,504 --> 01:23:56,105
AND REDUCE CONFOUNDING THE 

2064
01:23:56,105 --> 01:23:57,440
AUTHORS FIRST RESTRICTED TO 

2065
01:23:57,440 --> 01:23:59,008
INCIDENT USERS.

2066
01:23:59,008 --> 01:24:00,777
THEY BASICALLY KICKED OUT THE 

2067
01:24:00,777 --> 01:24:02,779
PREVALENT USERS FROM THE FIRST 

2068
01:24:02,779 --> 01:24:04,881
ROWS OF THE TABLE TO THOSE WHO 

2069
01:24:04,881 --> 01:24:06,115
ARE INCIDENT USERS.

2070
01:24:06,115 --> 01:24:07,583
AND THEY FURTHER RESTRICTED TO 

2071
01:24:07,583 --> 01:24:09,886
THOSE WHO HAD SIMILAR INDEX 

2072
01:24:09,886 --> 01:24:11,954
DATES, THAT IS ENTRY INTO THE 

2073
01:24:11,954 --> 01:24:15,725
COHORTS TO BEGIN FOLLOW-UP TO 

2074
01:24:15,725 --> 01:24:17,160
ADDRESS 1B SECTION OF THIS.

2075
01:24:17,160 --> 01:24:19,629
SO THEY MATCHED PATIENTS WHO 

2076
01:24:19,629 --> 01:24:22,098
SORT OF ENTERED THE COHORT AT 

2077
01:24:22,098 --> 01:24:23,366
SIMILAR DATES BASED ON 

2078
01:24:23,366 --> 01:24:25,201
MEDICATION OR VISIT DATES.

2079
01:24:25,201 --> 01:24:28,371
THAT WAS REALLY TO ADDRESS 

2080
01:24:28,371 --> 01:24:29,839
IMMORTAL TIME BIAS.

2081
01:24:29,839 --> 01:24:32,075
THEY FURTHER RESTRICTED TO NOT 

2082
01:24:32,075 --> 01:24:34,777
ALL OF NON-USERS BUT THOSE WHO 

2083
01:24:34,777 --> 01:24:36,679
WERE INITIATING GLAUCOMA 

2084
01:24:36,679 --> 01:24:39,215
MEDICATIONS WHICH WAS AN 

2085
01:24:39,215 --> 01:24:41,250
ATTEMPT, SINCE GLAUCOMA 

2086
01:24:41,250 --> 01:24:43,986
MEDICATIONS HAVE NO KNOWN 

2087
01:24:43,986 --> 01:24:45,888
PATHWAY TO MORTALITY, IT WAS IN 

2088
01:24:45,888 --> 01:24:49,025
EFFECT A PLACEBO BUT ACTIVELY 

2089
01:24:49,025 --> 01:24:51,494
TAKING SOME TYPE OF MEDICATION.

2090
01:24:51,494 --> 01:24:52,762
YOU COULD SEE AS THE 

2091
01:24:52,762 --> 01:24:55,465
RESTRICTION TO THIS COHORT WENT 

2092
01:24:55,465 --> 01:24:57,800
ON AND ON, RESTRICTING THE 

2093
01:24:57,800 --> 01:24:59,669
SAMPLE SIZES, THE EFFECT 

2094
01:24:59,669 --> 01:25:03,206
ESTIMATE BASED ON RATE RATIOS 

2095
01:25:03,206 --> 01:25:05,908
DROPPED WERE THE BIAS AWAY FROM 

2096
01:25:05,908 --> 01:25:07,577
THE NULL GRADUALLY WAS 

2097
01:25:07,577 --> 01:25:11,614
RESTRICTED FROM RATE RATIO 0.62 

2098
01:25:11,614 --> 01:25:13,850
DOWN TO THE FINAL ANALYSIS IN 

2099
01:25:13,850 --> 01:25:17,587
LINE 5 AT THE BOTTOM TO A RATE 

2100
01:25:17,587 --> 01:25:20,523
RATIO OF 0.79 WHICH MIMICKED 

2101
01:25:20,523 --> 01:25:22,158
THE PROSPER TRIAL THEY WERE 

2102
01:25:22,158 --> 01:25:24,293
USING AS AN ANCHOR FOR THE 

2103
01:25:24,293 --> 01:25:25,895
VALIDITY OF THIS OBSERVATIONAL 

2104
01:25:25,895 --> 01:25:26,629
STUDY.

2105
01:25:26,629 --> 01:25:29,098
SO THE POINT OF ALL THIS IS TO 

2106
01:25:29,098 --> 01:25:31,167
SAY WITH THROUGH THOUGHTFUL 

2107
01:25:31,167 --> 01:25:34,737
COHORT RESTRICTION, YOU CAN 

2108
01:25:34,737 --> 01:25:39,242
IMPROVE THE INTERNAL VALIDITY 

2109
01:25:39,242 --> 01:25:41,310
OF YOUR REAL-WORLD IFRDS BY 

2110
01:25:41,310 --> 01:25:42,712
TRYING TO ADDRESS CONFOUNDING 

2111
01:25:42,712 --> 01:25:44,814
IN THE COMPARATOR YOU ARE 

2112
01:25:44,814 --> 01:25:45,214
CHOOSING.

2113
01:25:45,214 --> 01:25:46,682
I REALIZE THAT'S A LOT.

2114
01:25:46,682 --> 01:25:48,451
BUT I WANTED TO HIGHLIGHT THIS 

2115
01:25:48,451 --> 01:25:51,220
AS A NICE ILLUSTRATION OF 

2116
01:25:51,220 --> 01:25:53,055
SAMPLE AND HOW IT CAN ADDRESS 

2117
01:25:53,055 --> 01:25:54,090
CONFOUNDING.

2118
01:25:54,090 --> 01:25:56,159
WITH THAT, LET ME TURN TO THE 

2119
01:25:56,159 --> 01:25:57,093
TRADE-OFFS IN THE DIFFERENT 

2120
01:25:57,093 --> 01:25:59,595
STUDY DESIGNS.

2121
01:25:59,595 --> 01:26:02,298
STARTING WITH HIGHLY CONTROLLED 

2122
01:26:02,298 --> 01:26:02,698
RANDOMIZED TRIALS.

2123
01:26:02,698 --> 01:26:05,201
WE KNOW DOES A GOOD JOB OF 

2124
01:26:05,201 --> 01:26:09,372
ADDRESSING CONFOUNDING THROUGH 

2125
01:26:09,372 --> 01:26:10,840
RANDOMIZATION, IT BALANCES IN 

2126
01:26:10,840 --> 01:26:16,679
OUR TABLE ONE, ALL OBSERVED 

2127
01:26:16,679 --> 01:26:17,313
CHARACTERISTICS AND CONFOUNDING 

2128
01:26:17,313 --> 01:26:20,216
SO WHAT WE END UP WITH IS 

2129
01:26:20,216 --> 01:26:21,417
EFFICACY ESTIMATE WITH STRONG 

2130
01:26:21,417 --> 01:26:22,752
INTERNAL VALIDITY.

2131
01:26:22,752 --> 01:26:26,455
BECAUSE IT'S A PROSPECTIVE 

2132
01:26:26,455 --> 01:26:30,426
DESIGN, THE MEASUREMENTS CAN BE 

2133
01:26:30,426 --> 01:26:31,227
TAILORED OR RESEARCH QUESTION 

2134
01:26:31,227 --> 01:26:32,929
IN A COUPLE WAYS.

2135
01:26:32,929 --> 01:26:34,597
WE CAN CHOOSE THE OUTCOMES THAT 

2136
01:26:34,597 --> 01:26:37,333
WE WANT TO ADDRESS, THE 

2137
01:26:37,333 --> 01:26:38,334
BASELINE MEASUREMENTS WE WANT 

2138
01:26:38,334 --> 01:26:40,603
TO ASSESS IN OUR SURVEYS AND 

2139
01:26:40,603 --> 01:26:42,038
DIRECTLY HAVE THOSE AVAILABLE 

2140
01:26:42,038 --> 01:26:44,974
IF THEY ARE NOT ROUTINELY 

2141
01:26:44,974 --> 01:26:47,076
AVAILABLE IN WHATEVER EHR DATA 

2142
01:26:47,076 --> 01:26:49,745
OR CLAIMS WE ARE USING TO HELP 

2143
01:26:49,745 --> 01:26:51,814
IDENTIFY ELIGIBLE PATIENTS.

2144
01:26:51,814 --> 01:26:53,850
AND WE CAN TIME THE 

2145
01:26:53,850 --> 01:26:55,084
MEASUREMENTS OF OUTCOMES AT THE 

2146
01:26:55,084 --> 01:26:57,787
TIMING WE THINK ARE IMPORTANT 

2147
01:26:57,787 --> 01:26:59,222
TO OBSERVE EFFECTS.

2148
01:26:59,222 --> 01:27:01,290
BUT THERE ARE A NUMBER OF 

2149
01:27:01,290 --> 01:27:02,225
LIMITATIONS TO HIGHLY 

2150
01:27:02,225 --> 01:27:03,259
CONTROLLED TRIALS.

2151
01:27:03,259 --> 01:27:05,895
THEY MAY NOT GENERALIZED THE 

2152
01:27:05,895 --> 01:27:08,831
REAL WORLD IF THEY ARE IN 

2153
01:27:08,831 --> 01:27:09,999
ACADEMIC MEDICAL CENTERS.

2154
01:27:09,999 --> 01:27:11,734
THEY MAY NOT SPEAK TO THE 

2155
01:27:11,734 --> 01:27:13,603
CLINICAL DECISIONS THAT ARE 

2156
01:27:13,603 --> 01:27:14,837
PARTICULARLY RELEVANT TO 

2157
01:27:14,837 --> 01:27:16,339
CLINICIANS IN THE FIELD IF 

2158
01:27:16,339 --> 01:27:19,642
PLACEBO IS THE COMPARATOR.

2159
01:27:19,642 --> 01:27:20,409
ACTIVE COMPARATORS COULD BE 

2160
01:27:20,409 --> 01:27:21,911
USED HERE.

2161
01:27:21,911 --> 01:27:24,013
THE EVIDENCE GENERATED MAY NOT 

2162
01:27:24,013 --> 01:27:27,083
BE RELEVANT TO THE FULL ARRAY 

2163
01:27:27,083 --> 01:27:28,517
OF PATIENTS RECEIVING THESE 

2164
01:27:28,517 --> 01:27:31,053
TREATMENTS AS IS TYPICALLY DONE 

2165
01:27:31,053 --> 01:27:35,424
IN THESE TRIALS, PREGNANT 

2166
01:27:35,424 --> 01:27:38,094
WOMEN, OLDER ADULTS, CHILDREN, 

2167
01:27:38,094 --> 01:27:40,997
ADOLESCENTS ARE EXCLUDED.

2168
01:27:40,997 --> 01:27:42,398
IF IT'S SMALL THEY MAY NOT HAVE 

2169
01:27:42,398 --> 01:27:45,735
THE POWER TO SPEAK TO EVENTS OR 

2170
01:27:45,735 --> 01:27:46,969
IDENTIFY SUBGROUPS WHO HAVE 

2171
01:27:46,969 --> 01:27:49,906
PARTICULAR BENEFITS OR HARMS.

2172
01:27:49,906 --> 01:27:51,741
TO HELP ADDRESS THIS PRAGMATIC 

2173
01:27:51,741 --> 01:27:53,843
TRIALS HAVE BEEN DONE MORE 

2174
01:27:53,843 --> 01:27:55,511
INCREASINGLY TO ADDRESS SOME OF 

2175
01:27:55,511 --> 01:27:58,547
THE LIMITATIONS OF THESE 

2176
01:27:58,547 --> 01:27:59,081
HIGHLY-CONTROLLED TRIALS.

2177
01:27:59,081 --> 01:28:00,650
THEY HAVE THE BENEFITS OF 

2178
01:28:00,650 --> 01:28:02,051
ADDRESSING CONFOUNDING THROUGH 

2179
01:28:02,051 --> 01:28:03,019
RANDOMIZATION AS WELL.

2180
01:28:03,019 --> 01:28:07,056
THEY ALSO HAVE THE ABILITY TO 

2181
01:28:07,056 --> 01:28:09,926
IMPROVE GENERALIZED ABILITY BY 

2182
01:28:09,926 --> 01:28:13,663
BEING IMPLEMENTED IN EMPLOYER 

2183
01:28:13,663 --> 01:28:15,331
SETTINGS, CHURCHES, GYMS, 

2184
01:28:15,331 --> 01:28:18,634
YMCA'S AND OTHER CONTEXT 

2185
01:28:18,634 --> 01:28:20,703
OUTPATIENT CLINICS NOT JUST 

2186
01:28:20,703 --> 01:28:23,639
MEDICAL SENT CENTERS.

2187
01:28:23,639 --> 01:28:29,145
THEY MAY BE MORE GENERALIZABLE.

2188
01:28:29,145 --> 01:28:30,046
THIS IS ILLUSTRATED IN THE 

2189
01:28:30,046 --> 01:28:32,381
FIGURE TO THE RIGHT WHICH IS AN 

2190
01:28:32,381 --> 01:28:34,283
ATTEMPT TO SUMMARIZE 

2191
01:28:34,283 --> 01:28:35,351
HYPOTHETICAL RESPONSE TO 

2192
01:28:35,351 --> 01:28:36,419
TREATMENT BY THE ELIGIBLE 

2193
01:28:36,419 --> 01:28:37,253
POPULATION.

2194
01:28:37,253 --> 01:28:40,189
THAT'S THE TOP CURVE.

2195
01:28:40,189 --> 01:28:41,691
THE BELL-SHAPED CURVE AT THE 

2196
01:28:41,691 --> 01:28:44,627
TOP, REPRESENTING THE 

2197
01:28:44,627 --> 01:28:46,529
POPULATION, WHICH CAN, SOME OF 

2198
01:28:46,529 --> 01:28:48,397
THEM IN THIS HYPOTHETICAL 

2199
01:28:48,397 --> 01:28:49,732
EXAMPLE ARE HARMED BECAUSE THE 

2200
01:28:49,732 --> 01:28:52,234
NET BENEFIT IS NEGATIVE, BELOW 

2201
01:28:52,234 --> 01:28:54,203
ZERO AND THERE ARE SOME 

2202
01:28:54,203 --> 01:28:55,504
PATIENTS WHO DERIVE GREAT 

2203
01:28:55,504 --> 01:28:58,441
BENEFIT FROM THE TREATMENT, NET 

2204
01:28:58,441 --> 01:29:01,310
BENEFIT OF 1.25 OR 2, BUT THE 

2205
01:29:01,310 --> 01:29:04,347
NET BENEFIT IS 0.5.

2206
01:29:04,347 --> 01:29:05,047
HIGHLY CONTROLLED TRIAL 

2207
01:29:05,047 --> 01:29:07,717
REPRESENTED BY THE TIGHTLY 

2208
01:29:07,717 --> 01:29:09,618
BOUND BELL-SHAPED CURVE 

2209
01:29:09,618 --> 01:29:13,889
CENTERED AT 0.5, BECAUSE OF THE 

2210
01:29:13,889 --> 01:29:14,890
RESTRICTIVE INCLUSION, 

2211
01:29:14,890 --> 01:29:16,792
EXCLUSION AREA IT DOESN'T CLUE 

2212
01:29:16,792 --> 01:29:17,626
THE FULL DISTRIBUTION OF 

2213
01:29:17,626 --> 01:29:20,730
RESPONSES IN THE POPULATION.

2214
01:29:20,730 --> 01:29:23,632
WHEREAS PRAGMATIC TRIAL BEING 

2215
01:29:23,632 --> 01:29:25,501
LESS RESTRICTIVE CAPTURES MORE 

2216
01:29:25,501 --> 01:29:26,936
DISTRIBUTION OF RESPONSES IN 

2217
01:29:26,936 --> 01:29:29,038
NET BENEFIT BUT NOT FULLY TO 

2218
01:29:29,038 --> 01:29:31,140
THE TAIL BEYOND NEGATIVE 0.1 OR 

2219
01:29:31,140 --> 01:29:33,442
ALL THE WAY TO TWO.

2220
01:29:33,442 --> 01:29:35,778
BUT IT DOES REPRESENT A MORE 

2221
01:29:35,778 --> 01:29:37,279
COMPLETE DISTRIBUTION OF 

2222
01:29:37,279 --> 01:29:38,881
PATIENT RESPONSES.

2223
01:29:38,881 --> 01:29:40,883
BY BEING A PROSPECTIVE DESIGN 

2224
01:29:40,883 --> 01:29:43,019
YOU CAN HAVE THE SAME 

2225
01:29:43,019 --> 01:29:45,287
MEASUREMENT BENEFITS AS THE 

2226
01:29:45,287 --> 01:29:47,156
HIGHLY CONTROLLED TRIAL.

2227
01:29:47,156 --> 01:29:50,760
THE POWER TO EVALUATE RARE 

2228
01:29:50,760 --> 01:29:52,361
EVENTS AND SUBGROUPS MAY BE 

2229
01:29:52,361 --> 01:29:54,463
LIMITED IF THE SAMPLE SIZE IS 

2230
01:29:54,463 --> 01:29:54,663
SMALL.

2231
01:29:54,663 --> 01:29:57,166
BUT BECAUSE IT'S REPRESENTING 

2232
01:29:57,166 --> 01:29:58,200
MORE POPULATION DISTRIBUTION 

2233
01:29:58,200 --> 01:30:00,503
AND RESPONSES IF YOU ARE ABLE 

2234
01:30:00,503 --> 01:30:03,506
TO DO, YOU MAY BE ABLE TO PICK 

2235
01:30:03,506 --> 01:30:12,748
UP HARMS IF THEY EXIST AND 

2236
01:30:12,748 --> 01:30:16,585
HETEROGENEITY IF THEY EXIST.

2237
01:30:16,585 --> 01:30:22,725
AND THEN TRIAL EMULATION, IN 

2238
01:30:22,725 --> 01:30:26,128
OUR QUASI EXPERIMENT OR 

2239
01:30:26,128 --> 01:30:28,097
NON-RANDOMIZED STUDY.

2240
01:30:28,097 --> 01:30:31,434
AND MIGUEL WILL TALK ABOUT THIS 

2241
01:30:31,434 --> 01:30:33,869
IN GREAT DEPTH.

2242
01:30:33,869 --> 01:30:37,506
THE GOAL IS TO OUTLINE, 

2243
01:30:37,506 --> 01:30:40,509
FORMALIZE WHAT WOULD BE THE 

2244
01:30:40,509 --> 01:30:45,581
IDEAL DOMAIN.

2245
01:30:45,581 --> 01:30:47,450
TREATMENT STRATEGIES, START-END 

2246
01:30:47,450 --> 01:30:49,518
OR FOLLOW-UP, CAUSAL CONTRASTS.

2247
01:30:49,518 --> 01:30:52,221
AND EMULATE IN THE ABSENCE OF 

2248
01:30:52,221 --> 01:30:53,089
RANDOMIZATION.

2249
01:30:53,089 --> 01:30:54,256
IN PARTICULAR, THIS LAST ONE, 

2250
01:30:54,256 --> 01:30:58,727
HOW ARE WE GOING TO DEAL WITH 

2251
01:30:58,727 --> 01:30:59,195
BASELINE/TIME-VARYING 

2252
01:30:59,195 --> 01:31:01,030
CONFOUNDING TO TRY TO ADDRESS 

2253
01:31:01,030 --> 01:31:02,565
SOURCES OF CONFOUNDING AND 

2254
01:31:02,565 --> 01:31:04,500
SELECTION BIAS?

2255
01:31:04,500 --> 01:31:06,602
THERE ARE TRADE-OFFS IN TRIAL 

2256
01:31:06,602 --> 01:31:07,536
EMULATION DESIGNS.

2257
01:31:07,536 --> 01:31:11,173
THERE ARE REAL BENEFITS OF 

2258
01:31:11,173 --> 01:31:13,576
GENERALIZABILITY BECAUSE WE 

2259
01:31:13,576 --> 01:31:15,644
WILL OBSERVE GENERALLY IN THE 

2260
01:31:15,644 --> 01:31:16,846
GLP-1 WORLD PATIENTS GETTING 

2261
01:31:16,846 --> 01:31:18,447
THEM ON AND OFF LABEL.

2262
01:31:18,447 --> 01:31:19,982
BECAUSE SO MANY PEOPLE ARE 

2263
01:31:19,982 --> 01:31:22,084
GETTING THESE MEDICATIONS WE 

2264
01:31:22,084 --> 01:31:23,919
PRESUMABLY WILL HAVE LARGE 

2265
01:31:23,919 --> 01:31:26,422
SAMPLES SO WE MAY HAVE 

2266
01:31:26,422 --> 01:31:29,425
STATISTICAL POWER TO MITIGATE 

2267
01:31:29,425 --> 01:31:31,694
RARE OUTCOMES AND SUBGROUP 

2268
01:31:31,694 --> 01:31:34,396
EFFECTS AND WE MAY BE ABLE TO 

2269
01:31:34,396 --> 01:31:39,768
EVALUATE A BROAD ARRAY OF 

2270
01:31:39,768 --> 01:31:41,904
COMPARATORS.

2271
01:31:41,904 --> 01:31:42,705
THERE'S UNOBSERVED CONFOUNDING 

2272
01:31:42,705 --> 01:31:45,374
THAT MAY BE PROBLEMATIC MAYBE 

2273
01:31:45,374 --> 01:31:47,676
WE CAN DETECT WITH NEGATIVE 

2274
01:31:47,676 --> 01:31:48,878
CONTROL OUTCOMES I WILL MENTION 

2275
01:31:48,878 --> 01:31:49,845
IN A MINUTE.

2276
01:31:49,845 --> 01:31:52,181
IF THEY AREN'T CAPTURED IN 

2277
01:31:52,181 --> 01:31:53,449
ROUTINE WE WON'T HAVE THEM.

2278
01:31:53,449 --> 01:31:55,918
AND THERE MAY BE MISSING DATA 

2279
01:31:55,918 --> 01:31:58,020
BECAUSE THE MEASUREMENTS ARE 

2280
01:31:58,020 --> 01:32:02,725
CONTINGENT ON PATIENTS GETTING 

2281
01:32:02,725 --> 01:32:02,925
CARE.

2282
01:32:02,925 --> 01:32:06,128
THIS COULD BE A WAY OF 

2283
01:32:06,128 --> 01:32:06,929
DETECTING POTENTIAL CONFOUNDING 

2284
01:32:06,929 --> 01:32:08,831
OR OTHER VALIDITY THREATS.

2285
01:32:08,831 --> 01:32:11,367
WHAT WE ARE TYPICALLY DOING, WE 

2286
01:32:11,367 --> 01:32:12,968
WANT TO LOOK AT OUTCOMES WE 

2287
01:32:12,968 --> 01:32:14,603
THINK WILL BE IMPROVED OR 

2288
01:32:14,603 --> 01:32:16,138
CHANGED BY OUR TREATMENT OF 

2289
01:32:16,138 --> 01:32:16,405
INTEREST.

2290
01:32:16,405 --> 01:32:20,376
SO WE ARE TESTING WITH A TEST.

2291
01:32:20,376 --> 01:32:21,710
BRINGING OTHER OUTCOMES AND 

2292
01:32:21,710 --> 01:32:23,412
LAMP POSTS WE MAY NOT BE 

2293
01:32:23,412 --> 01:32:26,949
LOOKING UNDER, IT SETS A HIGHER 

2294
01:32:26,949 --> 01:32:29,251
THRESHOLD FOR THE HYPOTHESIS 

2295
01:32:29,251 --> 01:32:30,853
THAN IF STUDIES DON'T HAVE.

2296
01:32:30,853 --> 01:32:33,889
BECAUSE THE NULL HYPOTHESIS 

2297
01:32:33,889 --> 01:32:36,792
THAT GLP-1'S DON'T AFFECT 

2298
01:32:36,792 --> 01:32:40,095
OUTCOME CAN ONLY BE IMPACTED IF 

2299
01:32:40,095 --> 01:32:42,998
IT CHANGES OUTCOMES AS EXPECTED 

2300
01:32:42,998 --> 01:32:44,667
AND IT DOESN'T CHANGE OUTCOMES 

2301
01:32:44,667 --> 01:32:46,702
WE DON'T EXPECT TO BE AFFECTED.

2302
01:32:46,702 --> 01:32:50,906
I DID A STUDY IN EARLY 2010'S 

2303
01:32:50,906 --> 01:32:56,946
LOOKING AT EFFECT OF ADHERENCE 

2304
01:32:56,946 --> 01:33:01,450
FOR INSURANCE.

2305
01:33:01,450 --> 01:33:09,558
GENERICS IN THIS CONTEXT FOR 

2306
01:33:09,558 --> 01:33:12,828
TREATING DIABETES, HYPER 

2307
01:33:12,828 --> 01:33:17,233
LIPIDEMIA.

2308
01:33:17,233 --> 01:33:19,301
ARB'S AND CAI.

2309
01:33:19,301 --> 01:33:20,769
WE EXPECTED IMPROVEMENT IN THE 

2310
01:33:20,769 --> 01:33:23,038
SIX CLASSES WHERE THERE WERE NO 

2311
01:33:23,038 --> 01:33:24,707
GENERICS BUT NO CHANGES IN THE 

2312
01:33:24,707 --> 01:33:27,076
TWO CLASSES WHERE THERE WERE 

2313
01:33:27,076 --> 01:33:28,210
NOT GENERICKS.

2314
01:33:28,210 --> 01:33:33,215
WE BELIEVE THE VBID PROGRAM OF 

2315
01:33:33,215 --> 01:33:36,085
COST-SHARING REDUCTIONS DID 

2316
01:33:36,085 --> 01:33:36,919
IMPROVE ADHERENCE, BECAUSE WE 

2317
01:33:36,919 --> 01:33:39,188
SAW CHANGES IN THE SIX CLASSES 

2318
01:33:39,188 --> 01:33:41,090
WHERE WE EXPECTED THEM AND WE 

2319
01:33:41,090 --> 01:33:42,524
DIDN'T SEE CHANGES IN THE TWO 

2320
01:33:42,524 --> 01:33:44,026
CLASSES WHERE WE DIDN'T EXPECT 

2321
01:33:44,026 --> 01:33:46,061
CHANGES.

2322
01:33:46,061 --> 01:33:47,963
SO THE COMBINATION GAVE US 

2323
01:33:47,963 --> 01:33:50,466
GREATER CONFIDENCE THE VBID 

2324
01:33:50,466 --> 01:33:51,800
EFFECTS WERE REAL.

2325
01:33:51,800 --> 01:33:54,203
IF WE SAW JUMPS IN THE ARB'S 

2326
01:33:54,203 --> 01:33:57,373
AND CAI THAT WOULD BE A SIGNAL 

2327
01:33:57,373 --> 01:33:58,173
THERE'S SOME CONFOUNDING 

2328
01:33:58,173 --> 01:33:59,675
RUNNING THROUGH THE DRUG 

2329
01:33:59,675 --> 01:34:01,310
CLASSES WE HADN'T ACCOUNTED FOR.

2330
01:34:01,310 --> 01:34:03,579
SO THEY COULD BE A USEFUL 

2331
01:34:03,579 --> 01:34:05,648
DESIGN FEATURE TO ADD.

2332
01:34:05,648 --> 01:34:08,150
ANOTHER THING IS IN RANDOMIZED 

2333
01:34:08,150 --> 01:34:11,120
TRIALS CAN ONLY CONDITION 

2334
01:34:11,120 --> 01:34:11,954
ENROLLMENTS ON MEASUREMENTS YOU 

2335
01:34:11,954 --> 01:34:14,857
HAVE UP TO AND ON THE DAY OF 

2336
01:34:14,857 --> 01:34:15,190
RANDOMIZATION.

2337
01:34:15,190 --> 01:34:16,825
YOU CAN'T CONDITION THE SAMPLE 

2338
01:34:16,825 --> 01:34:20,162
ON FUTURE INFORMATION.

2339
01:34:20,162 --> 01:34:23,032
IN RETROSPECTIVE CO-HORTON 

2340
01:34:23,032 --> 01:34:25,367
THERE IS TREATMENT INFORMATION 

2341
01:34:25,367 --> 01:34:28,070
THAT SHOULD NOT BE CONDITIONED 

2342
01:34:28,070 --> 01:34:31,607
ON IN THIS RECENT STUDY, THE 

2343
01:34:31,607 --> 01:34:35,110
AUTHORS DID CONDITION ON 

2344
01:34:35,110 --> 01:34:35,911
POST-INITIATION EXCLUSIONS 

2345
01:34:35,911 --> 01:34:38,447
RELATED TO CANCER PREGNANCY AND 

2346
01:34:38,447 --> 01:34:39,548
BARIATRIC SURGERY BUT YOU CAN'T 

2347
01:34:39,548 --> 01:34:41,717
DO THAT IN THE TRIAL SO 

2348
01:34:41,717 --> 01:34:43,619
SHOULDN'T DO IT SO DON'T DO 

2349
01:34:43,619 --> 01:34:48,991
THIS IN YOUR RETROACTIVE  -- 

2350
01:34:48,991 --> 01:34:50,459
>> Kimberly Narain:
THERE'S 

2351
01:34:50,459 --> 01:34:51,393
ABOUT THREE MINUTES LEFT.

2352
01:34:51,393 --> 01:34:54,163
>> David >> Matthew 

2353
01:34:54,163 --> 01:34:55,864
Maciejewski: LET ME COMMENT, 

2354
01:34:55,864 --> 01:34:58,334
HOW MUCH NON ADHERENCE WE ARE 

2355
01:34:58,334 --> 01:35:00,202
SEEING IN THE REAL WORLD ON 

2356
01:35:00,202 --> 01:35:01,904
GLP-1'S.

2357
01:35:01,904 --> 01:35:04,139
TO COMPLEMENT OUR ITT ANALYSES 

2358
01:35:04,139 --> 01:35:07,076
COULD BE USEFUL TO UNDERSTAND 

2359
01:35:07,076 --> 01:35:08,777
DIFFERENTIAL NON ADHERENCE OF 

2360
01:35:08,777 --> 01:35:10,646
TREATMENT GROUPS, MAYBE THE 

2361
01:35:10,646 --> 01:35:11,647
TYPE OF GLP-1'S.

2362
01:35:11,647 --> 01:35:13,982
HELP US UNDERSTAND 

2363
01:35:13,982 --> 01:35:15,451
DOSE-DEPENDENT EFFECTS AND HELP 

2364
01:35:15,451 --> 01:35:17,886
US UNDERSTAND THE LONG TERM 

2365
01:35:17,886 --> 01:35:19,555
EFFECTS, WHAT ARE THE BENEFITS 

2366
01:35:19,555 --> 01:35:23,525
AND HARMS OF 20-YEAR CONTINUOUS 

2367
01:35:23,525 --> 01:35:28,263
ADHERENCE TO [BEEP]'S.

2368
01:35:28,263 --> 01:35:30,933
--  GLP-1'S.

2369
01:35:30,933 --> 01:35:34,303
SINCE THE TIME OF HIPPOCRATES 

2370
01:35:34,303 --> 01:35:40,709
AS A REAL ISSUE.

2371
01:35:40,709 --> 01:35:43,812
C. EVERETT KOOP REINFORCED THAT.

2372
01:35:43,812 --> 01:35:47,149
THE STUDY FOUND MEDICAL AND 

2373
01:35:47,149 --> 01:35:49,218
NON-MEDICAL REASONS FOR 

2374
01:35:49,218 --> 01:35:50,686
DISCONTINUATION.

2375
01:35:50,686 --> 01:35:53,355
OUT OF POCKET COSTS OF THEM, 

2376
01:35:53,355 --> 01:35:54,189
PEOPLE SWITCHING MEDICATION 

2377
01:35:54,189 --> 01:35:56,258
COVERAGE THAT DOES AND DOESN'T 

2378
01:35:56,258 --> 01:35:59,161
COVER IT AND OTHER REASONS 

2379
01:35:59,161 --> 01:35:59,828
NON-MEDICAL WE NEED TO 

2380
01:35:59,828 --> 01:36:00,863
UNDERSTAND BETTER THAN WE DO 

2381
01:36:00,863 --> 01:36:02,698
NOW.

2382
01:36:02,698 --> 01:36:04,933
REAL WORLD EVIDENCE SUGGEST 

2383
01:36:04,933 --> 01:36:06,402
DISCONTINUATION RATES IN THE 

2384
01:36:06,402 --> 01:36:08,737
TRIALS ARE NOT TRANSPORTED INTO 

2385
01:36:08,737 --> 01:36:10,639
THE REAL WORLD.

2386
01:36:10,639 --> 01:36:13,175
IN REAL WORLD, NON-ADHERENCE 

2387
01:36:13,175 --> 01:36:15,644
RATES ARE VERY HIGH, 

2388
01:36:15,644 --> 01:36:17,946
DISCONTINUATION ARE HIGH BOTH 

2389
01:36:17,946 --> 01:36:19,381
FOR SEMAGLUTIDE AND TIRZEPATIDE.

2390
01:36:19,381 --> 01:36:22,651
THIS IS AN AREA WE NEED MORE 

2391
01:36:22,651 --> 01:36:22,851
WORK.

2392
01:36:22,851 --> 01:36:24,019
IN CONCLUSION, THERE'S AN 

2393
01:36:24,019 --> 01:36:30,058
URGENT NEED FOR REAL-WORLD 

2394
01:36:30,058 --> 01:36:31,760
EVIDENCE OF GLP-1 WITH STRONG 

2395
01:36:31,760 --> 01:36:37,366
INTERNAL VALIDITY, BROAD 

2396
01:36:37,366 --> 01:36:39,001
GENERALIZABILITY AND PRINCIPLED 

2397
01:36:39,001 --> 01:36:40,569
SUBGROUP EFFECT ESTIMATION.

2398
01:36:40,569 --> 01:36:44,006
WE WILL NEED THE FULL SPECTRUM 

2399
01:36:44,006 --> 01:36:45,274
OF STUDY DESIGNS TO DOUGH THIS.

2400
01:36:45,274 --> 01:36:47,309
THEY ALL HAVE TRADE OFFS BUT 

2401
01:36:47,309 --> 01:36:49,044
TARGET TRIALS MAY BE 

2402
01:36:49,044 --> 01:36:50,245
PARTICULARLY IMPORTANT, THE 

2403
01:36:50,245 --> 01:36:53,348
LARGE SAMPLES LET US LOOK AT 

2404
01:36:53,348 --> 01:36:55,017
RARE EVENTS, SUBGROUP, OFF 

2405
01:36:55,017 --> 01:36:57,986
LABEL AND CHARACTERISTICS AND 

2406
01:36:57,986 --> 01:36:59,188
OUTCOMES FOLLOWING 

2407
01:36:59,188 --> 01:36:59,555
DISCONTINUATION.

2408
01:36:59,555 --> 01:37:00,522
THERE'S A NUMBER OF DATA 

2409
01:37:00,522 --> 01:37:01,690
SOURCES TO DO THIS WORK.

2410
01:37:01,690 --> 01:37:04,026
BECAUSE THIS IS SO COMPLICATED 

2411
01:37:04,026 --> 01:37:05,461
I THINK TEAM SCIENCE IS THE 

2412
01:37:05,461 --> 01:37:07,763
ONLY WAY FORWARD.

2413
01:37:07,763 --> 01:37:09,398
THERE ARE IMPORTANT GAPS AND 

2414
01:37:09,398 --> 01:37:10,699
OPPORTUNITIES WE ALL KNOW IN 

2415
01:37:10,699 --> 01:37:13,001
THIS SPACE AND WE WILL HELP 

2416
01:37:13,001 --> 01:37:14,136
SURFACE IN THE NEXT DAY AND A 

2417
01:37:14,136 --> 01:37:15,270
HALF.

2418
01:37:15,270 --> 01:37:17,105
SOME OF WHICH I TALKED ABOUT.

2419
01:37:17,105 --> 01:37:18,574
AND WITH THAT, I WILL STOP AND 

2420
01:37:18,574 --> 01:37:22,911
TAKE QUESTIONS.

2421
01:37:22,911 --> 01:37:23,879
>> Kimberly Narain: THANK
YOU 

2422
01:37:23,879 --> 01:37:24,646
FOR THAT.

2423
01:37:24,646 --> 01:37:27,316
I AM JUST GOING TO SAY A QUICK 

2424
01:37:27,316 --> 01:37:28,917
REMINDER TO PUT YOUR QUESTIONS 

2425
01:37:28,917 --> 01:37:30,018
IN THE Q&A.

2426
01:37:30,018 --> 01:37:32,488
IF THE QUESTION IS FOR THE 

2427
01:37:32,488 --> 01:37:34,356
SPEAKER AND NOT IN REFERENCE TO 

2428
01:37:34,356 --> 01:37:36,658
A GAP, PLEASE PUT THE SPEAKER'S 

2429
01:37:36,658 --> 01:37:39,194
NAME THERE, JUST TO HELP US 

2430
01:37:39,194 --> 01:37:39,461
IDENTIFY.

2431
01:37:39,461 --> 01:37:42,898
AND SO THIS QUESTION COMES FROM 

2432
01:37:42,898 --> 01:37:43,932
JAIME MOORE, I BELIEVE.

2433
01:37:43,932 --> 01:37:45,767
AND THE QUESTION IS, WHAT ARE 

2434
01:37:45,767 --> 01:37:47,269
THE KEY CONSIDERATIONS TO 

2435
01:37:47,269 --> 01:37:49,338
CREATE A SYSTEM THAT 

2436
01:37:49,338 --> 01:37:50,806
SPECIFICALLY TAKES A LIFE 

2437
01:37:50,806 --> 01:37:53,275
COURSE LENS TO TRACK OUTCOMES 

2438
01:37:53,275 --> 01:37:56,578
FOR INDIVIDUALS WITH GLP-1 R.A. 

2439
01:37:56,578 --> 01:37:59,314
EXPOSURE FROM CHILDHOOD THROUGH 

2440
01:37:59,314 --> 01:37:59,715
ADULTHOOD?

2441
01:37:59,715 --> 01:38:02,985
>> Matthew Maciejewski:
WELL, 

2442
01:38:02,985 --> 01:38:04,887
THAT'S A GREAT QUESTION.

2443
01:38:04,887 --> 01:38:09,091
WE NEED TO DO DATA LINKAGES, 

2444
01:38:09,091 --> 01:38:13,028
SINCE PATIENTS CHANGE HEALTH 

2445
01:38:13,028 --> 01:38:14,263
SYSTEMS AND INSURANCES OVER THE 

2446
01:38:14,263 --> 01:38:16,131
COURSE OF THEIR LIFESTYLES SO 

2447
01:38:16,131 --> 01:38:19,868
WE NEED, WE CAN STITCH TOGETHER 

2448
01:38:19,868 --> 01:38:23,405
POTENTIALLY WHAT MIGHT BE A 

2449
01:38:23,405 --> 01:38:25,240
SINGLE-PAYER SYSTEM IF WE HAVE 

2450
01:38:25,240 --> 01:38:26,842
LOTS OF RESOURCES AT OUR 

2451
01:38:26,842 --> 01:38:27,709
DISPOSAL.

2452
01:38:27,709 --> 01:38:30,646
I THINK IT'S VERY IMPORTANT TO 

2453
01:38:30,646 --> 01:38:32,414
POSTULATE WHAT WOULD BE THE 

2454
01:38:32,414 --> 01:38:33,415
IDEAL DATA STRUCTURE.

2455
01:38:33,415 --> 01:38:35,417
WE TRY TO FIGURE OUT WAYS IN 

2456
01:38:35,417 --> 01:38:38,787
WHICH TO BUILD THE DREAM.

2457
01:38:38,787 --> 01:38:40,622
I DON'T THINK SUCH A THING 

2458
01:38:40,622 --> 01:38:45,193
EXISTS AT SCALE RIGHT NOW.

2459
01:38:45,193 --> 01:38:46,862
>> Kimberly Narain: I HAVE

2460
01:38:46,862 --> 01:38:49,965
ANOTHER QUESTION HERE.

2461
01:38:49,965 --> 01:38:55,103
THIS COMES FROM PAULINA KAREVA, 

2462
01:38:55,103 --> 01:38:55,370
I BELIEVE.

2463
01:38:55,370 --> 01:38:58,840
IT SAYS HAVE YOU USED TRINET 

2464
01:38:58,840 --> 01:39:00,509
REAL WORLD DATA NETWORK, HOW 

2465
01:39:00,509 --> 01:39:01,777
DOES IT COMPARE TO THE OTHERS?

2466
01:39:01,777 --> 01:39:02,844
>> Matthew Maciejewski:
I'M 

2467
01:39:02,844 --> 01:39:04,713
SORRY TO SAY I HAVE NOT.

2468
01:39:04,713 --> 01:39:10,118
SO I CAN'T SPEAK TO THAT.

2469
01:39:10,118 --> 01:39:11,787
>> Kimberly Narain: WHAT
ELSE 

2470
01:39:11,787 --> 01:39:13,855
DO WE HAVE COMING HERE?

2471
01:39:13,855 --> 01:39:15,724
OKAY.

2472
01:39:15,724 --> 01:39:21,063
SO THIS IS FROM PATRICK 

2473
01:39:21,063 --> 01:39:22,397
SWAOEGERT.

2474
01:39:22,397 --> 01:39:25,100
IS TRIAL EMULATION FEASIBLE FOR 

2475
01:39:25,100 --> 01:39:27,803
GLP-1 VERSUS BARIATRIC SURGERY 

2476
01:39:27,803 --> 01:39:29,905
QUESTIONS USING REAL-WORLD DATA?

2477
01:39:29,905 --> 01:39:31,974
OR IS THE UNMEASURED 

2478
01:39:31,974 --> 01:39:32,708
CONFOUNDING TOO GREAT?

2479
01:39:32,708 --> 01:39:33,609
>> Matthew Maciejewski:
YEAH, 

2480
01:39:33,609 --> 01:39:35,711
THAT'S A GREAT QUESTION.

2481
01:39:35,711 --> 01:39:40,449
I KNOW THERE ARE EVALUATIONS 

2482
01:39:40,449 --> 01:39:41,883
ONGOING, DO TARGET TRIAL 

2483
01:39:41,883 --> 01:39:44,920
EMULATION IN THAT EXACT SPACE.

2484
01:39:44,920 --> 01:39:50,892
I THINK IT IS POSSIBLE TO DO SO 

2485
01:39:50,892 --> 01:39:51,960
WITH SOME QUALIFICATIONS.

2486
01:39:51,960 --> 01:39:54,863
THE FIRST IS THAT BARIATRIC 

2487
01:39:54,863 --> 01:39:56,131
SURGERY AT LEAST, WHICH I HAVE 

2488
01:39:56,131 --> 01:39:59,501
DONE A LOT OF WORK IN, WITH 

2489
01:39:59,501 --> 01:40:01,336
DAVID ARTERBURN AND OTHERS, 

2490
01:40:01,336 --> 01:40:04,406
OFTEN IN TRIALS AND IN ROUTINE 

2491
01:40:04,406 --> 01:40:07,576
CLINICAL PRACTICE, THERE ARE 

2492
01:40:07,576 --> 01:40:08,410
PSYCHIATRIC REFERRALS TO 

2493
01:40:08,410 --> 01:40:10,345
DETERMINE IF A PATIENT IS A 

2494
01:40:10,345 --> 01:40:11,813
GOOD CANDIDATE.

2495
01:40:11,813 --> 01:40:14,116
AND THE INFORMATION ON THE 

2496
01:40:14,116 --> 01:40:15,717
SEVERITY OF PEOPLE'S MENTAL 

2497
01:40:15,717 --> 01:40:20,789
HEALTH CONDITIONS IF THEY ARE 

2498
01:40:20,789 --> 01:40:22,057
PREVALENT ARE TYPICALLY NOT 

2499
01:40:22,057 --> 01:40:23,659
OBSERVED.

2500
01:40:23,659 --> 01:40:28,697
SO WE CAN'T APPLY EXCLUSIONS TO 

2501
01:40:28,697 --> 01:40:32,801
OUR COMPARATOR, NON-SURGICAL 

2502
01:40:32,801 --> 01:40:35,504
COMPARATOR, IN ORDER TO 

2503
01:40:35,504 --> 01:40:36,338
IDENTIFY, BECAUSE WHAT YOU 

2504
01:40:36,338 --> 01:40:39,241
WOULD WANT TO DO IS COMPARE 

2505
01:40:39,241 --> 01:40:41,576
PEOPLE WHO ARE ELIGIBLE FOR 

2506
01:40:41,576 --> 01:40:43,612
BOTH INTERVENTIONS.

2507
01:40:43,612 --> 01:40:47,182
AND NOT ALL INCLUSION/EXCLUSION 

2508
01:40:47,182 --> 01:40:49,551
CRITERIA ARE OBSERVABLE IN 

2509
01:40:49,551 --> 01:40:51,887
ROUTINELY-COLLECTED DATA.

2510
01:40:51,887 --> 01:40:53,188
IN MENTAL HEALTH CONDITIONS, 

2511
01:40:53,188 --> 01:40:55,757
SEVERITY IS ONE OF THEM.

2512
01:40:55,757 --> 01:40:59,528
WE DON'T OBSERVE THE LIFESTYLE 

2513
01:40:59,528 --> 01:41:02,230
MODIFICATIONS OF BOTH DIET AND 

2514
01:41:02,230 --> 01:41:03,899
EXERCISE THAT PEOPLE MAY OR MAY 

2515
01:41:03,899 --> 01:41:05,767
NOT BE DOING AFTER INITIATION 

2516
01:41:05,767 --> 01:41:07,235
OF THESE TREATMENTS AND THAT'S 

2517
01:41:07,235 --> 01:41:09,271
A SOURCE OF CONFOUNDING.

2518
01:41:09,271 --> 01:41:13,542
AND SO I THINK THAT IS A 

2519
01:41:13,542 --> 01:41:17,179
LIMITATION.

2520
01:41:17,179 --> 01:41:21,717
BUT IT IS, I THINK, GIVEN THAT 

2521
01:41:21,717 --> 01:41:24,453
THE WEIGHT LOSS AND OTHER 

2522
01:41:24,453 --> 01:41:26,121
HEALTH EFFECTS OF THESE 

2523
01:41:26,121 --> 01:41:29,424
INTERVENTIONS ARE SO GREAT, I 

2524
01:41:29,424 --> 01:41:31,727
DON'T BELIEVE THAT THE 

2525
01:41:31,727 --> 01:41:32,961
BEHAVIORAL CHANGES THAT WE'RE 

2526
01:41:32,961 --> 01:41:35,263
MISSING THAT WE CAN OBSERVE ARE 

2527
01:41:35,263 --> 01:41:37,132
GOING TO COMPLETELY SWAMP THE 

2528
01:41:37,132 --> 01:41:40,869
EFFECTS OF THOSE TREATMENTS ON 

2529
01:41:40,869 --> 01:41:42,504
OUTCOMES.

2530
01:41:42,504 --> 01:41:44,539
SO I'M CAUTIOUSLY OPTIMISTIC 

2531
01:41:44,539 --> 01:41:49,344
THAT CAN BE DONE.

2532
01:41:49,344 --> 01:41:55,217
>> Kimberly Narain: OKAY.

2533
01:41:55,217 --> 01:42:00,956
THIS IS FROM ARAVA CUACA.

2534
01:42:00,956 --> 01:42:06,328
ON THE NOTE OF YOUR HEALTHY 

2535
01:42:06,328 --> 01:42:08,029
ADHERERS AND STOPPERS OF THE 

2536
01:42:08,029 --> 01:42:10,298
MEDS IS THERE ANALYSIS IN 

2537
01:42:10,298 --> 01:42:13,201
VARIOUS GROUPS OF POPULATIONS?

2538
01:42:13,201 --> 01:42:14,636
>> Matthew Maciejewski: I
THINK 

2539
01:42:14,636 --> 01:42:17,172
IT'S A VERY ACTIVE AND OPEN 

2540
01:42:17,172 --> 01:42:19,207
AREA OF INVESTIGATION.

2541
01:42:19,207 --> 01:42:24,479
TO BE ABLE TO UNDERSTAND THE 

2542
01:42:24,479 --> 01:42:27,182
REASONS FOR NON-ADHERENCE OR 

2543
01:42:27,182 --> 01:42:28,216
DISCONTINUATION, YOU PROBABLY 

2544
01:42:28,216 --> 01:42:30,152
NEED TO DO PRIMARY DATA 

2545
01:42:30,152 --> 01:42:33,622
COLLECTION OF SOME KIND TO 

2546
01:42:33,622 --> 01:42:37,959
SURVEY PATIENTS, BASICALLY.

2547
01:42:37,959 --> 01:42:43,799
I THINK THERE ARE A FEW, THE 

2548
01:42:43,799 --> 01:42:47,302
GASSOIAN THAT DAVID SHOWED AND 

2549
01:42:47,302 --> 01:42:48,670
I REFERENCED, BUT I THINK THIS 

2550
01:42:48,670 --> 01:42:51,139
IS A VERY OPEN AREA FOR WORK.

2551
01:42:51,139 --> 01:42:52,741
>> Kimberly Narain:
ANOTHER 

2552
01:42:52,741 --> 01:42:58,547
QUESTION IS COMING FROM, LET'S 

2553
01:42:58,547 --> 01:42:59,948
GIVE SOMEONE ANOTHER 

2554
01:42:59,948 --> 01:43:05,153
OPPORTUNITY HERE.

2555
01:43:05,153 --> 01:43:06,688
KHADIR, DO WE STILL THINK IN 

2556
01:43:06,688 --> 01:43:09,691
THE UPCOMING FEW YEARS OLDER 

2557
01:43:09,691 --> 01:43:11,993
ANTI-OBESITY DRUGS WILL STILL 

2558
01:43:11,993 --> 01:43:13,829
BE SUITABLE ALTERNATIVES IN 

2559
01:43:13,829 --> 01:43:15,864
TARGET STUDIES OF GLP-1'S?

2560
01:43:15,864 --> 01:43:17,032
>> Matthew Maciejewski:
YEAH, 

2561
01:43:17,032 --> 01:43:19,968
THAT'S A GREAT QUESTION.

2562
01:43:19,968 --> 01:43:23,705
THIS AREA IS SO DYNAMIC AND NEW 

2563
01:43:23,705 --> 01:43:26,174
TECHNOLOGIES ARE COMING ON SO 

2564
01:43:26,174 --> 01:43:28,210
FAST THAT IT IS HARD TO PREDICT 

2565
01:43:28,210 --> 01:43:31,847
THE FUTURE.

2566
01:43:31,847 --> 01:43:37,285
BUT PHENTERMINE IS A FAIRLY 

2567
01:43:37,285 --> 01:43:38,720
EFFECTIVE MEDICATION THAT, THIS 

2568
01:43:38,720 --> 01:43:42,524
IS PERSONAL OPINION, MIGHT BE A 

2569
01:43:42,524 --> 01:43:43,758
POTENTIAL FIRST-LINE OPTION, 

2570
01:43:43,758 --> 01:43:47,495
SINCE IT'S REALLY INEXENSIVE.

2571
01:43:47,495 --> 01:43:51,867
SINCE ITS, I BELIEVE, GENERIC.

2572
01:43:51,867 --> 01:43:54,035
IT COULD BE, IF THERE'S 

2573
01:43:54,035 --> 01:43:55,370
EVENTUALLY TRIALS OF STEP 

2574
01:43:55,370 --> 01:43:58,306
THERAPY WHERE YOU GET PEOPLE TO 

2575
01:43:58,306 --> 01:43:59,341
TRY BEHAVIORAL INTERVENTION AND 

2576
01:43:59,341 --> 01:44:03,745
TRY THEM ON SOMETHING 

2577
01:44:03,745 --> 01:44:04,579
INEXPENSIVE LIKE PHENTERMINE 

2578
01:44:04,579 --> 01:44:06,481
AND IF THEY DON'T SUCCEED, YOU 

2579
01:44:06,481 --> 01:44:08,950
SWITCH THEM TO ONE OF THESE 

2580
01:44:08,950 --> 01:44:10,418
MORE EXPENSIVE GLP-1'S, I CAN 

2581
01:44:10,418 --> 01:44:12,053
SEE THAT BEING USEFUL IN THIS 

2582
01:44:12,053 --> 01:44:13,188
CONTEXT.

2583
01:44:13,188 --> 01:44:15,891
IF WE REALLY WANT TO TAKE A 

2584
01:44:15,891 --> 01:44:17,125
POPULATION-BASED APPROACH TO 

2585
01:44:17,125 --> 01:44:18,426
WEIGHT MANAGEMENT, WE ARE GOING 

2586
01:44:18,426 --> 01:44:21,396
TO NEED THE FULL ARRAY OF 

2587
01:44:21,396 --> 01:44:24,966
BEHAVIORAL, PHARMACOLOGIC AND 

2588
01:44:24,966 --> 01:44:27,068
SURGICAL INTERVENTIONS AND THE 

2589
01:44:27,068 --> 01:44:29,537
OPTIMAL MIX IN A PORTFOLIO OF 

2590
01:44:29,537 --> 01:44:32,173
INTERVENTIONS IS TOTALLY 

2591
01:44:32,173 --> 01:44:32,407
UNKNOWN.

2592
01:44:32,407 --> 01:44:33,074
>> Kimberly Narain: I
THINK 

2593
01:44:33,074 --> 01:44:35,377
THIS WILL BE OUR LAST QUESTION 

2594
01:44:35,377 --> 01:44:38,947
HERE.

2595
01:44:38,947 --> 01:44:45,854
THIS IS PAULINA KHUKEVA.

2596
01:44:45,854 --> 01:44:48,123
WHAT DO YOU THINK OF USING A.

2597
01:44:48,123 --> 01:44:53,561
I. METHODS IN ADDITION?

2598
01:44:53,561 --> 01:44:55,931
>> Matthew Maciejewski: A.

2599
01:44:55,931 --> 01:44:59,167
I. METHODS CAN BE USEFUL FOR, 

2600
01:44:59,167 --> 01:45:02,137
IF ARE DOING WEIGHTING OR 

2601
01:45:02,137 --> 01:45:04,673
MATCHING METHODS, BOOSTED 

2602
01:45:04,673 --> 01:45:06,775
GRADIENT FORESTS AND SUCH 

2603
01:45:06,775 --> 01:45:10,512
METHODS HAVE BEEN USEFUL FOR 

2604
01:45:10,512 --> 01:45:11,346
GENERATING PROPENSITY-BASED 

2605
01:45:11,346 --> 01:45:15,116
KIND OF MODELS THAT PREDICT WHO 

2606
01:45:15,116 --> 01:45:16,551
GETS TREATMENT, VERSUS NOT 

2607
01:45:16,551 --> 01:45:18,653
TREATMENT, OR TREATMENT A, 

2608
01:45:18,653 --> 01:45:19,721
VERSUS TREATMENT B.

2609
01:45:19,721 --> 01:45:24,059
THEY ARE BEING USED IN SUBGROUP 

2610
01:45:24,059 --> 01:45:27,262
IDENTIFICATION METHODS, CAUSAL 

2611
01:45:27,262 --> 01:45:30,332
FOREST BY SUSAN ATHY AND OTHERS.

2612
01:45:30,332 --> 01:45:32,200
SO I THINK A.

2613
01:45:32,200 --> 01:45:35,337
I. IS GOING TO BE USEFUL IN 

2614
01:45:35,337 --> 01:45:36,805
THOSE PARTICULAR CONTEXTS AND 

2615
01:45:36,805 --> 01:45:37,405
MAYBE OTHERS.

2616
01:45:37,405 --> 01:45:40,275
BUT A.

2617
01:45:40,275 --> 01:45:45,246
I., FUNDAMENTALLY, WE NEED A 

2618
01:45:45,246 --> 01:45:48,383
GOOD , RICH DATASETS.

2619
01:45:48,383 --> 01:45:54,222
IT CAN'T MAGICALLY SOLVE CAUSAL 

2620
01:45:54,222 --> 01:45:54,723
INFERENCE, CONFOUNDING 

2621
01:45:54,723 --> 01:45:57,225
PROBLEMS, IF YOU ARE IN A 

2622
01:45:57,225 --> 01:45:59,527
REALLY SPARSE DATASET.

2623
01:45:59,527 --> 01:46:01,196
AND THAT REMINDS ME OF A QUOTE, 

2624
01:46:01,196 --> 01:46:03,331
WHICH IS SOMETHING LIKE, YOU 

2625
01:46:03,331 --> 01:46:05,433
CAN'T MAKE RIGHT BY STATISTICS 

2626
01:46:05,433 --> 01:46:07,068
WHAT YOU HAVE DONE WRONG BY 

2627
01:46:07,068 --> 01:46:09,004
DESIGN.

2628
01:46:09,004 --> 01:46:10,672
>> Kimberly Narain: THANK
YOU.

2629
01:46:10,672 --> 01:46:12,540
I THINK THAT'S A GREAT PLACE TO 

2630
01:46:12,540 --> 01:46:14,809
END OUR DISCUSSION.

2631
01:46:14,809 --> 01:46:16,177
>> Matthew Maciejewski:
THANKS 

2632
01:46:16,177 --> 01:46:23,985
VERY MUCH.

2633
01:46:23,985 --> 01:46:25,153
>> Craig Hales: GREAT,
THANK 

2634
01:46:25,153 --> 01:46:28,757
YOU SO MUCH FOR THAT KEYNOTE 

2635
01:46:28,757 --> 01:46:29,958
PRESENTATIONS TO GET US KICKED 

2636
01:46:29,958 --> 01:46:30,592
OFF.

2637
01:46:30,592 --> 01:46:32,293
WE WILL GO AHEAD AND TAKE A 

2638
01:46:32,293 --> 01:46:34,329
BREAK NOW.

2639
01:46:34,329 --> 01:46:36,991
AND WE WILL RECONVENE AT 11:00.

2640
01:47:52,822 --> 01:47:55,825
HAS BEEN AT THE FDA FOR THE 

2641
01:47:55,825 --> 01:47:59,162
LAST 11 YEARS, SHE LEADS FDA'S 

2642
01:47:59,162 --> 01:48:00,230
ADVANCING REAL WORLD EVIDENCE 

2643
01:48:00,230 --> 01:48:03,767
PROGRAM AND LEADS A PORTFOLIO 

2644
01:48:03,767 --> 01:48:05,802
OF EXTERNALLY CONDUCTED 

2645
01:48:05,802 --> 01:48:06,469
REAL-WORLD EVIDENCE PROJECTS 

2646
01:48:06,469 --> 01:48:09,172
AND SHE IS ALSO CONTRIBUTES TO 

2647
01:48:09,172 --> 01:48:10,740
GUIDANCE DEVELOPMENT.

2648
01:48:10,740 --> 01:48:12,008
DR. BRADLEY WILL BE SPEAKING ON 

2649
01:48:12,008 --> 01:48:14,744
THE USE OF REAL-WORLD EVIDENCE 

2650
01:48:14,744 --> 01:48:18,915
FOR REGULATORY DECISION MAKING.

2651
01:48:18,915 --> 01:48:21,351
DR. BRADLEY?

2652
01:48:21,351 --> 01:48:22,819
>> THANKS, CHRISTINA, I
WILL 

2653
01:48:22,819 --> 01:48:23,954
SHARE MY SLIDES, CAN YOU HEAR 

2654
01:48:23,954 --> 01:48:25,388
ME OKAY?

2655
01:48:25,388 --> 01:48:35,498
YEAH?

2656
01:48:37,167 --> 01:48:37,934
OKAY, GREAT.

2657
01:48:37,934 --> 01:48:39,469
CAN EVERYBODY HEAR ME AND SEE 

2658
01:48:39,469 --> 01:48:42,305
MY SLIDES?

2659
01:48:42,305 --> 01:48:44,040
PERFECT.

2660
01:48:44,040 --> 01:48:45,875
SO AS CHRISTINA SAID, I'M HERE 

2661
01:48:45,875 --> 01:48:50,246
TODAY MOSTLY TO TALK ABOUT THE 

2662
01:48:50,246 --> 01:48:51,314
FDA, REAL-WORLD EVIDENCE 

2663
01:48:51,314 --> 01:48:52,949
PROGRAM AND SOME WORK WE ARE 

2664
01:48:52,949 --> 01:48:58,622
DOING ON THE SAFETY OF GLP-1'S.

2665
01:48:58,622 --> 01:49:00,490
THIS SPEECH REFLECTS MY VIEWS 

2666
01:49:00,490 --> 01:49:04,828
AND NOT THE VIEWS OF FDA AND 

2667
01:49:04,828 --> 01:49:10,600
SHOULDN'T BE CONSTRUED TO 

2668
01:49:10,600 --> 01:49:11,868
REPRESENT FDA'S VIEWS OR 

2669
01:49:11,868 --> 01:49:13,870
POLICIES, I HAVE NO CONFLICTS 

2670
01:49:13,870 --> 01:49:16,439
OF INTEREST.

2671
01:49:16,439 --> 01:49:19,142
PRODUCTS SHOULDN'T BE CONSTRUED 

2672
01:49:19,142 --> 01:49:20,810
AS ENDORSEMENT *.

2673
01:49:20,810 --> 01:49:29,152
WE WILL GO THROUGH FDA REAL 

2674
01:49:29,152 --> 01:49:31,888
WORLD EVIDENCE.

2675
01:49:31,888 --> 01:49:38,762
THE CURES ACT OF 2016 FDA SHALL 

2676
01:49:38,762 --> 01:49:40,630
ESTABLISH A PROGRAM TO EVALUATE 

2677
01:49:40,630 --> 01:49:43,366
THE POTENTIAL USE OF REAL-WORLD 

2678
01:49:43,366 --> 01:49:45,068
EVIDENCE TO SUPPORT NEW 

2679
01:49:45,068 --> 01:49:48,571
INDICATION FOR A DRUG APPROVED 

2680
01:49:48,571 --> 01:49:52,575
UNDER SECTION 505C AND SATISFY 

2681
01:49:52,575 --> 01:49:54,778
POST-APPROVAL STUDY 

2682
01:49:54,778 --> 01:49:55,111
REQUIREMENTS.

2683
01:49:55,111 --> 01:49:57,380
AND SHALL ESTABLISH A DRAFT 

2684
01:49:57,380 --> 01:49:58,648
FRAMEWORK, DESCRIBE SOURCES OF 

2685
01:49:58,648 --> 01:50:00,717
EVIDENCE, GAPS IN DATA 

2686
01:50:00,717 --> 01:50:01,818
COLLECTION ACTIVITIES PD ET 

2687
01:50:01,818 --> 01:50:03,019
CETERA.

2688
01:50:03,019 --> 01:50:04,487
FDA SHALL ISSUE DRAFT GUIDANCE 

2689
01:50:04,487 --> 01:50:08,425
FOR INDUSTRY AND OTHER 

2690
01:50:08,425 --> 01:50:11,327
STAKEHOLDERS WHICH WOULD FIND 

2691
01:50:11,327 --> 01:50:12,562
APPROPRIATE STANDARDS, DATA 

2692
01:50:12,562 --> 01:50:15,665
SOURCES, THINGS LIKE THAT.

2693
01:50:15,665 --> 01:50:23,773
AND SO, IN 2018, FDA PUT OUT 

2694
01:50:23,773 --> 01:50:25,542
THEIR DECEMBER 2018 PUT OUT 

2695
01:50:25,542 --> 01:50:27,977
FRAMEWORK FOR DRUGS AND 

2696
01:50:27,977 --> 01:50:29,612
BIOLOGICS.

2697
01:50:29,612 --> 01:50:31,848
THIS APPLIES TO CENTER FOR 

2698
01:50:31,848 --> 01:50:34,551
DRUGS AND BIOLOGICS ON THE 

2699
01:50:34,551 --> 01:50:37,253
ONCOLOGY CENTER FOR EXCELLENCE.

2700
01:50:37,253 --> 01:50:39,355
REAL WORLD EVIDENCE, IT'S A 

2701
01:50:39,355 --> 01:50:40,390
MULTIFACETED PROGRAM WHICH 

2702
01:50:40,390 --> 01:50:42,225
INCLUDES THINGS LIKE INTERNAL 

2703
01:50:42,225 --> 01:50:43,326
AGENCY PROCESSES.

2704
01:50:43,326 --> 01:50:46,262
WE HAVE A REAL-WORLD EVIDENCE 

2705
01:50:46,262 --> 01:50:48,331
SUBCOMMITTEE THAT GETS TOGETHER 

2706
01:50:48,331 --> 01:50:50,266
WITH SENIOR LEADERSHIP TO 

2707
01:50:50,266 --> 01:50:53,169
DISCUSS ISSUES PERTINENT TO 

2708
01:50:53,169 --> 01:50:54,771
REAL-WORLD EVIDENCE AT THE 

2709
01:50:54,771 --> 01:50:55,705
AGENCY.

2710
01:50:55,705 --> 01:50:58,007
AND WE INVITE EXTERNAL PARTIES 

2711
01:50:58,007 --> 01:51:04,647
TO PRESENT ON THE REAL-WORLD 

2712
01:51:04,647 --> 01:51:08,685
EVIDENCE SUBCOMMITTEE AND WHERE 

2713
01:51:08,685 --> 01:51:14,524
THEY CONSULT ON ADMISSIONS FOR 

2714
01:51:14,524 --> 01:51:15,925
REAL-WORLD DATA.

2715
01:51:15,925 --> 01:51:18,762
WE DO EXTENSIVE EXTERNAL 

2716
01:51:18,762 --> 01:51:20,363
ENGAGEMENT.

2717
01:51:20,363 --> 01:51:21,798
WE DO THINGS LIKE WHAT I'M 

2718
01:51:21,798 --> 01:51:23,933
DOING TODAY AND WE TALK WITH 

2719
01:51:23,933 --> 01:51:26,002
PANELS, WE GO TO CONFERENCES 

2720
01:51:26,002 --> 01:51:26,870
AND MEETINGS.

2721
01:51:26,870 --> 01:51:31,107
AND AS I MENTIONED WE BRING 

2722
01:51:31,107 --> 01:51:35,211
EXTERNAL PARTIES TO HEAR SOME 

2723
01:51:35,211 --> 01:51:37,747
OF THEIR IDEAS.

2724
01:51:37,747 --> 01:51:41,084
AND LARGE DEMONSTRATION 

2725
01:51:41,084 --> 01:51:46,022
RESEARCH PROJECTS REHATED  --  

2726
01:51:46,022 --> 01:51:54,164
RELATED TO THE METHODOLOGIC.

2727
01:51:54,164 --> 01:51:57,267
AND CONSIDERATIONS WHEN USING 

2728
01:51:57,267 --> 01:51:58,935
REAL-WORLD DATA AND EVIDENCE IN 

2729
01:51:58,935 --> 01:52:05,208
REGULATORY DECISION MAKING.

2730
01:52:05,208 --> 01:52:07,043
I THINK THE LAST PRESENTATION 

2731
01:52:07,043 --> 01:52:08,912
COULD HAVED THESE DEFINITIONS, 

2732
01:52:08,912 --> 01:52:10,814
JUST TO ARTICULATE THESE ARE 

2733
01:52:10,814 --> 01:52:14,317
THE OFFICIAL FDA DEFINITIONS OF 

2734
01:52:14,317 --> 01:52:16,486
BOTH REAL-WORLD DATA AND 

2735
01:52:16,486 --> 01:52:18,922
REAL-WORLD EVIDENCE.

2736
01:52:18,922 --> 01:52:20,390
REAL-WORLD DATA ARE CONSTRUED 

2737
01:52:20,390 --> 01:52:22,492
AS DATA THAT ARE ROUTINELY 

2738
01:52:22,492 --> 01:52:23,893
COLLECTED.

2739
01:52:23,893 --> 01:52:25,962
SOMETIMES IF YOU HAVE 

2740
01:52:25,962 --> 01:52:27,430
POTENTIALLY A REGISTRY SET UP 

2741
01:52:27,430 --> 01:52:29,299
BY A SPONSOR FOR THE PURPOSES 

2742
01:52:29,299 --> 01:52:33,336
OF CONDUCTING A POST-MARKETING 

2743
01:52:33,336 --> 01:52:38,675
REQUIREMENT THAT WAS PUT 

2744
01:52:38,675 --> 01:52:43,046
TOGETHER A PROTOCOL, THAT 

2745
01:52:43,046 --> 01:52:48,785
WOULDN'T REALLY FALL  --  

2746
01:52:48,785 --> 01:52:49,886
SOURCES OF REAL-WORLD DATA AS 

2747
01:52:49,886 --> 01:52:52,355
WE HEAR FROM THE LAST 

2748
01:52:52,355 --> 01:52:54,190
PRESENTATION, ELECTRONIC HEALTH 

2749
01:52:54,190 --> 01:52:55,658
RECORDS, MEDICAL CLAIMS DATA 

2750
01:52:55,658 --> 01:52:58,161
AND PRODUCT AND DISEASE 

2751
01:52:58,161 --> 01:53:01,464
REGISTRIS.

2752
01:53:01,464 --> 01:53:03,533
THE EVIDENCE DERIVED FROM 

2753
01:53:03,533 --> 01:53:05,802
VARIOUS STUDY DESIGNS COVERED 

2754
01:53:05,802 --> 01:53:09,372
BY THE LAST PRESENTATION ON 

2755
01:53:09,372 --> 01:53:11,207
TRIALS, PRAGMATIC, EXTERNALLY 

2756
01:53:11,207 --> 01:53:14,210
CONTROLLED AND OBSERVATIONAL 

2757
01:53:14,210 --> 01:53:15,178
STUDIES.

2758
01:53:15,178 --> 01:53:17,413
SO MY COLLEAGUES PUBLISHED THIS 

2759
01:53:17,413 --> 01:53:23,219
PAPER IN 2024 IN 

2760
01:53:23,219 --> 01:53:25,822
PHARMACOEPIDEMIOLOGY AND DRUG 

2761
01:53:25,822 --> 01:53:26,055
SAFETY.

2762
01:53:26,055 --> 01:53:28,157
WHEN CAN REAL-WORLD DATA, IT 

2763
01:53:28,157 --> 01:53:33,596
HAS MANY USES AND CERTAINLY THE 

2764
01:53:33,596 --> 01:53:35,298
SCIENCE AND HEALTH CARE SPACE.

2765
01:53:35,298 --> 01:53:40,870
JUST TO GIVE AN IDEA WHEN FDA 

2766
01:53:40,870 --> 01:53:41,437
CAN GENERATE REAL-WORLD 

2767
01:53:41,437 --> 01:53:42,772
EVIDENCE.

2768
01:53:42,772 --> 01:53:49,846
I INCLUDED A DATA TABLE.

2769
01:53:49,846 --> 01:53:51,514
FOR EXAMPLE, COULD HAVE AN 

2770
01:53:51,514 --> 01:53:54,450
INTERTEN VUN SHL STUDY YOU 

2771
01:53:54,450 --> 01:53:57,587
MIGHT USE REAL-WORLD DATA TO 

2772
01:53:57,587 --> 01:54:00,556
SELECT TRIALS TO IDENTIFY 

2773
01:54:00,556 --> 01:54:01,057
POTENTIAL PARTICIPANTS.

2774
01:54:01,057 --> 01:54:05,528
THAT WOULD NOT BE WHAT WE 

2775
01:54:05,528 --> 01:54:06,329
CONSIDER REAL-WORLD EVIDENCE 

2776
01:54:06,329 --> 01:54:08,031
FOR THE PURPOSES OF REGULATORY 

2777
01:54:08,031 --> 01:54:09,465
DECISION MAKING.

2778
01:54:09,465 --> 01:54:11,901
CONVERSELY, IF THEY USED 

2779
01:54:11,901 --> 01:54:13,369
REAL-WORLD DATA FOR ITS 

2780
01:54:13,369 --> 01:54:16,506
ENDPOINT IT WOULD BE DEEMED TO 

2781
01:54:16,506 --> 01:54:17,140
HAVE GENERATED REAL-WORLD 

2782
01:54:17,140 --> 01:54:18,608
EVIDENCE THAT COULD BE 

2783
01:54:18,608 --> 01:54:20,043
CONSIDERED IN REGULATORY 

2784
01:54:20,043 --> 01:54:21,077
DECISION MAKING.

2785
01:54:21,077 --> 01:54:24,580
SIMILARLY, IN EXTERNALLY 

2786
01:54:24,580 --> 01:54:26,282
CONTROLLED TRIALS, MIGHT HAVE 

2787
01:54:26,282 --> 01:54:29,152
AN EXTERNAL CONTROL ARM THAT 

2788
01:54:29,152 --> 01:54:31,187
USES REAL-WORLD DATA FROM A 

2789
01:54:31,187 --> 01:54:33,056
DATA SOURCE THAT WOULD BE 

2790
01:54:33,056 --> 01:54:35,391
DEEMED TO HAVE REAL-WORLD 

2791
01:54:35,391 --> 01:54:37,927
EVIDENCE AND OBVIOUSLY ON THESE 

2792
01:54:37,927 --> 01:54:39,729
INTERVENTIONS, DESIGNS LIKE AN 

2793
01:54:39,729 --> 01:54:42,632
OBSERVATION ALICO HORTON, 

2794
01:54:42,632 --> 01:54:43,866
REAL-WORLD EVIDENCE IS THE 

2795
01:54:43,866 --> 01:54:46,736
TOPIC OF THE STUDY, TYPICALLY.

2796
01:54:46,736 --> 01:54:48,905
NEXT I WANTED TO TOUCH ON SOME 

2797
01:54:48,905 --> 01:54:50,606
OF OUR GUIDANCES, AS I 

2798
01:54:50,606 --> 01:54:53,943
MENTIONED WE PUBLISH A SUITE OF 

2799
01:54:53,943 --> 01:54:54,978
EIGHT DIFFERENT GUIDANCES.

2800
01:54:54,978 --> 01:54:57,347
FIVE ARE FINAL VERSIONS AND 

2801
01:54:57,347 --> 01:55:04,320
THREE ARE IN DRAFT.

2802
01:55:04,320 --> 01:55:06,990
ACCORDING TO STAKEHOLDER 

2803
01:55:06,990 --> 01:55:08,491
COMMENTS.

2804
01:55:08,491 --> 01:55:13,162
THEY ARE CATEGORIZED A CCORDING 

2805
01:55:13,162 --> 01:55:15,465
TO THEIR CONTENT.

2806
01:55:15,465 --> 01:55:17,433
WE PUT GUIDANCE ON THE USE OF 

2807
01:55:17,433 --> 01:55:18,134
REGISTRIS.

2808
01:55:18,134 --> 01:55:20,169
IN TERMS OF IF YOU ARE 

2809
01:55:20,169 --> 01:55:21,604
CONSIDERING USING THESE DATA 

2810
01:55:21,604 --> 01:55:23,039
SOURCES, THESE ARE THE THINGS 

2811
01:55:23,039 --> 01:55:25,808
THAT FDA NEED YOU TO CONSIDER 

2812
01:55:25,808 --> 01:55:27,276
AND VARIOUS RECOMMENDATIONS 

2813
01:55:27,276 --> 01:55:31,180
AROUND DATA, SO THESE DATA 

2814
01:55:31,180 --> 01:55:33,449
SOURCES AND MOVING ONTO THE 

2815
01:55:33,449 --> 01:55:34,984
DESIGN PHASE WE PUT OUT 

2816
01:55:34,984 --> 01:55:37,186
RECOMMENDATIONS FOR THE USE OF 

2817
01:55:37,186 --> 01:55:39,022
EXTERNALLY CONTROLLED TRIALS 

2818
01:55:39,022 --> 01:55:42,358
WHICH ACTUALLY DIDN'T INCLUDE 

2819
01:55:42,358 --> 01:55:44,861
HIGH  -- 

2820
01:55:44,861 --> 01:55:47,163
WE PUT OUT GUIDANCE CONCERNING 

2821
01:55:47,163 --> 01:55:50,266
DESIGN CONSIDERATIONS FOR RCT'S 

2822
01:55:50,266 --> 01:55:51,934
AND CLINICAL PRACTICE SETTINGS, 

2823
01:55:51,934 --> 01:55:53,603
WHICH AGAIN WAS MENTIONED IN 

2824
01:55:53,603 --> 01:55:55,071
THE LAST PRESENTATION.

2825
01:55:55,071 --> 01:55:56,939
WHERE YOU KNOW, WE ARE USING 

2826
01:55:56,939 --> 01:55:59,008
SORT OF MORE PRAGMATIC ELEMENTS 

2827
01:55:59,008 --> 01:56:00,476
WITHIN THE HEALTH CARE SYSTEM 

2828
01:56:00,476 --> 01:56:03,579
TO CONDUCT THE RCT'S.

2829
01:56:03,579 --> 01:56:07,350
WE ALSO PUT OUT VARIOUS 

2830
01:56:07,350 --> 01:56:11,921
PROCEDURAL GUIDANCE ON WHERE TO 

2831
01:56:11,921 --> 01:56:13,790
SUBMIT DATA AND REGULATORY 

2832
01:56:13,790 --> 01:56:16,893
CONSIDERATION WHEN USING THESE 

2833
01:56:16,893 --> 01:56:19,429
DATA FOR SUBMISSION TO SUPPORT 

2834
01:56:19,429 --> 01:56:20,229
REGULATORY DECISION MAKING.

2835
01:56:20,229 --> 01:56:21,697
THE LINK ON THIS SLIDE WILL 

2836
01:56:21,697 --> 01:56:25,668
GIVE AN OVER VIEW MORE IN 

2837
01:56:25,668 --> 01:56:27,570
DEPTH, YOU DON'T HAVE TO GO 

2838
01:56:27,570 --> 01:56:29,205
THROUGH ALL EIGHT, IF ANYONE 

2839
01:56:29,205 --> 01:56:31,908
HAS ANY FURTHER INTEREST IN 

2840
01:56:31,908 --> 01:56:37,280
THAT.

2841
01:56:37,280 --> 01:56:40,216
RECENTLY CDER CENTER FOR REAL 

2842
01:56:40,216 --> 01:56:42,752
WORLD EVIDENCE INNOVATION 

2843
01:56:42,752 --> 01:56:43,019
LAUNCHED.

2844
01:56:43,019 --> 01:56:46,756
IT WAS A NICE PUBLIC MEETING IN 

2845
01:56:46,756 --> 01:56:51,327
DECEMBER 2024.

2846
01:56:51,327 --> 01:56:55,064
CCRI, THE AIM IS TO PROMOTE 

2847
01:56:55,064 --> 01:56:56,732
CONSISTENT SIGHIVEIC REVIEW AND 

2848
01:56:56,732 --> 01:56:59,469
KNOWLEDGE MANAGEMENT ACROSS THE 

2849
01:56:59,469 --> 01:57:01,537
GRIPS THAT ARE CONSIDERING THIS 

2850
01:57:01,537 --> 01:57:03,005
TYPE OF DATA FOR REGULATORY 

2851
01:57:03,005 --> 01:57:04,173
DECISION MAKING.

2852
01:57:04,173 --> 01:57:06,476
IN TERMS OF ENSURING CONSISTENT 

2853
01:57:06,476 --> 01:57:10,313
ASSESSMENT OF THE ADEQUACY OF 

2854
01:57:10,313 --> 01:57:12,315
REAL-WORLD DATA AND RELATED 

2855
01:57:12,315 --> 01:57:13,950
STUDY DESIGNS FOR REGULATORY 

2856
01:57:13,950 --> 01:57:15,585
DECISION MAKING, THE CENTER 

2857
01:57:15,585 --> 01:57:18,054
WILL ALSO BE CONCERNED WITH 

2858
01:57:18,054 --> 01:57:19,755
PROMOTING CONSISTENT SCIENTIFIC 

2859
01:57:19,755 --> 01:57:22,859
REVIEW ACROSS OTHER CENTERS AND 

2860
01:57:22,859 --> 01:57:25,161
FDA AND RELATE DEVELOP 

2861
01:57:25,161 --> 01:57:26,496
KNOWLEDGE MANAGEMENT AND 

2862
01:57:26,496 --> 01:57:27,864
RESOURCES FOR STAFF.

2863
01:57:27,864 --> 01:57:29,765
ANOTHER AIM IS TO DRIVE-IN 

2864
01:57:29,765 --> 01:57:31,367
NOVATION IN THE SPACE BY 

2865
01:57:31,367 --> 01:57:33,836
CONTINUING TO ADDRESS GAPS IN 

2866
01:57:33,836 --> 01:57:35,304
REGULATORY SCIENCE AND POLICY.

2867
01:57:35,304 --> 01:57:38,407
SO THE FOCUS AREAS FOR CCRI ARE 

2868
01:57:38,407 --> 01:57:43,112
SCIENTIFIC REVIEW AND POLICY, 

2869
01:57:43,112 --> 01:57:44,580
AGAIN, MAINTAINING AND 

2870
01:57:44,580 --> 01:57:47,116
EXTENDING OUR COORDINATED 

2871
01:57:47,116 --> 01:57:48,117
OUTREACH ENGAGEMENT WITH 

2872
01:57:48,117 --> 01:57:50,853
PARTIES OF THE AGENCY.

2873
01:57:50,853 --> 01:57:53,356
ADVANCING RESEARCH INITIATIVES 

2874
01:57:53,356 --> 01:57:56,025
AND DEVELOPING KNOWLEDGE 

2875
01:57:56,025 --> 01:57:57,527
MANAGEMENT REPOSITORIES.

2876
01:57:57,527 --> 01:58:03,766
INTERNALLY.

2877
01:58:03,766 --> 01:58:07,403
NOW I WANT TO TALK ABOUT FDA 

2878
01:58:07,403 --> 01:58:09,438
APPROACH TO EVALUATING 

2879
01:58:09,438 --> 01:58:13,576
SUBMISSIONS RELATED TO 

2880
01:58:13,576 --> 01:58:14,010
REAL-WORLD EVIDENCE.

2881
01:58:14,010 --> 01:58:16,879
THE STANDARD FOR ASSESSING 

2882
01:58:16,879 --> 01:58:18,748
THESE SUBMISSIONS DOESN'T 

2883
01:58:18,748 --> 01:58:20,650
CHANGE.

2884
01:58:20,650 --> 01:58:23,352
THE FOUNDATIONAL CONCERN ARE 

2885
01:58:23,352 --> 01:58:25,488
DATA FIT FOR USE.

2886
01:58:25,488 --> 01:58:29,492
FIT FOR USE COMPRISES TWO 

2887
01:58:29,492 --> 01:58:29,859
CONSIDERATIONS.

2888
01:58:29,859 --> 01:58:30,826
RELEVANCE.

2889
01:58:30,826 --> 01:58:33,362
DOES THE POTENTIAL DATA SOURCE 

2890
01:58:33,362 --> 01:58:34,830
BEING CONSIDERED CONTAIN THE 

2891
01:58:34,830 --> 01:58:36,465
RELEVANT INFORMATION ON THE 

2892
01:58:36,465 --> 01:58:37,733
STUDY ELEMENTS YOU NEED TO 

2893
01:58:37,733 --> 01:58:40,236
ANSWER YOUR STUDY QUESTION.

2894
01:58:40,236 --> 01:58:43,139
DOES IT CAPTURE YOUR EXPOSURES 

2895
01:58:43,139 --> 01:58:46,008
AND COVARIATES IN AN ADEQUATE 

2896
01:58:46,008 --> 01:58:46,842
MANNER.

2897
01:58:46,842 --> 01:58:49,345
DO YOU ALLOW THE STUDY TO 

2898
01:58:49,345 --> 01:58:49,579
HAPPEN.

2899
01:58:49,579 --> 01:58:52,215
THE RELIABILITY ON THE OTHER 

2900
01:58:52,215 --> 01:58:54,717
HAND MAY OR MAY NOT BE QUESTION 

2901
01:58:54,717 --> 01:58:56,552
AGNOSTIC.

2902
01:58:56,552 --> 01:58:58,654
HOWEVER RELIABLE ARE THE DATA, 

2903
01:58:58,654 --> 01:59:00,623
HOW ACCURATE, CAN THE DATA 

2904
01:59:00,623 --> 01:59:01,857
THAT'S MEASURED BE COMPARED 

2905
01:59:01,857 --> 01:59:06,028
WITH A SOURCE OF TRUTH AND WHO 

2906
01:59:06,028 --> 01:59:07,096
COMPLETED YOUR DATA?

2907
01:59:07,096 --> 01:59:10,633
IF YOU ONLY HAVE CLAIMS DATA, 

2908
01:59:10,633 --> 01:59:12,902
ARE YOU MISSING IMPORTANT 

2909
01:59:12,902 --> 01:59:15,738
CONFOUNDERS THAT MIGHT BE 

2910
01:59:15,738 --> 01:59:17,240
SUPPORTED.

2911
01:59:17,240 --> 01:59:18,507
WITHIN DATA SOURCES WHAT ARE 

2912
01:59:18,507 --> 01:59:22,345
THE EX TINT AMPLE TEND OF 

2913
01:59:22,345 --> 01:59:24,814
MISSING THE CONFOUNDER 

2914
01:59:24,814 --> 01:59:25,114
PRINCIPLES.

2915
01:59:25,114 --> 01:59:27,550
AND TRACEABILITY, SOMETIMES 

2916
01:59:27,550 --> 01:59:38,060
THESE PRIVACY AND DATA CAN GO 

2917
01:59:38,327 --> 01:59:39,729
THROUGH VARIOUS ITERATIONS, IS 

2918
01:59:39,729 --> 01:59:41,163
YOUR DATA TRACEABLE TO THE 

2919
01:59:41,163 --> 01:59:43,266
SOURCE DATA AND THE RELIABILITY 

2920
01:59:43,266 --> 01:59:44,533
AROUND THAT.

2921
01:59:44,533 --> 01:59:47,270
THE SECOND CONSIDERATION OF 

2922
01:59:47,270 --> 01:59:49,338
COURSE IS THE STUDY DESIGN YOU 

2923
01:59:49,338 --> 01:59:50,172
HAVE CHOSEN TO ANSWER YOUR 

2924
01:59:50,172 --> 01:59:51,407
QUESTION.

2925
01:59:51,407 --> 01:59:54,744
CAN IT GENERATE ADEQUATE 

2926
01:59:54,744 --> 01:59:56,646
SCIENTIFIC EVIDENCE.

2927
01:59:56,646 --> 01:59:58,748
TO HELP ANSWER REGULATORY 

2928
01:59:58,748 --> 01:59:59,348
QUESTION.

2929
01:59:59,348 --> 02:00:02,818
OBVIOUSLY THERE'S A VERY HIGH 

2930
02:00:02,818 --> 02:00:04,854
BAR FOR ASSESSING SUBMISSIONS 

2931
02:00:04,854 --> 02:00:06,989
THAT SUPPORT A REGULATORY 

2932
02:00:06,989 --> 02:00:07,923
DECISION.

2933
02:00:07,923 --> 02:00:11,260
AND WHETHER STUDY CONDUCT MEETS 

2934
02:00:11,260 --> 02:00:12,528
FDA REGULATORY REQUIREMENTS.

2935
02:00:12,528 --> 02:00:15,865
THERE ARE SEVERAL REQUIREMENTS 

2936
02:00:15,865 --> 02:00:19,769
AROUND DATA SUBMISSION THAT 

2937
02:00:19,769 --> 02:00:21,470
NEED IN ORDER THAT THE DATA CAN 

2938
02:00:21,470 --> 02:00:23,072
BE CONSIDERED.

2939
02:00:23,072 --> 02:00:24,974
I WILL BRIEFLY TOUCH ON A 

2940
02:00:24,974 --> 02:00:27,677
COUPLE EXAMPLES OF WHERE 

2941
02:00:27,677 --> 02:00:29,779
REAL-WORLD EVIDENCE HAS 

2942
02:00:29,779 --> 02:00:30,746
CONTRIBUTED SUBSTANTIALLY TO 

2943
02:00:30,746 --> 02:00:32,014
REGULATORY DECISIONS.

2944
02:00:32,014 --> 02:00:34,984
THE FIRST AND PROBABLY ONE OF 

2945
02:00:34,984 --> 02:00:45,161
THE MORE WELL-KNOWN IS 

2946
02:00:45,161 --> 02:00:46,362
TACROLIMUS, PROGRAF FOR LIVER 

2947
02:00:46,362 --> 02:00:47,630
TRANSPLANT.

2948
02:00:47,630 --> 02:00:49,832
BASED ON EVIDENCE FROM RCT'S.

2949
02:00:49,832 --> 02:00:56,439
THERE WERE NO RCT'S FOR LONE 

2950
02:00:56,439 --> 02:01:00,376
TRANSPLANT SO SPONSOR PROPOSE 

2951
02:01:00,376 --> 02:01:03,512
APPLICATION FOR THAT.

2952
02:01:03,512 --> 02:01:06,415
AND THE STUDY DATA AND DESIGN 

2953
02:01:06,415 --> 02:01:08,684
WERE EVALUATED A CODING TO FDA 

2954
02:01:08,684 --> 02:01:11,554
STANDARDS AND IT WAS GRANTED 

2955
02:01:11,554 --> 02:01:14,623
APPROVAL IN JULY 2021 FOR 

2956
02:01:14,623 --> 02:01:18,327
PREVENTING INFECTION IN 

2957
02:01:18,327 --> 02:01:18,627
TRANSPLANTS.

2958
02:01:18,627 --> 02:01:22,932
IT WAS A VERY WELL KNOWN AND 

2959
02:01:22,932 --> 02:01:27,403
RIGOROUS MAINTAINED DATABASE OF 

2960
02:01:27,403 --> 02:01:30,306
REGISTRY OF LUNG TRANSPLANT.

2961
02:01:30,306 --> 02:01:32,341
THE PATIENT LEVEL DATA FROM THE 

2962
02:01:32,341 --> 02:01:34,110
REGISTRY WAS PROVIDED TO FDA AS 

2963
02:01:34,110 --> 02:01:35,878
PART OF THE REVIEW PROCESS.

2964
02:01:35,878 --> 02:01:43,719
AND IT  WAS A 

2965
02:01:43,719 --> 02:01:44,153
NON-INTERVENTIONAL 

2966
02:01:44,153 --> 02:01:45,821
OBSERVATIONAL TREATMENT GROUP.

2967
02:01:45,821 --> 02:01:50,860
COMPARED TO HISTORICAL CONTROLS.

2968
02:01:50,860 --> 02:01:54,830
OF NOTE IN THIS SITUATION, THE 

2969
02:01:54,830 --> 02:02:00,236
OUTCOMES ARE VIRTUALLY CERTAIN 

2970
02:02:00,236 --> 02:02:02,338
WITHOUT THERAPY, DRAMATIC 

2971
02:02:02,338 --> 02:02:03,606
EFFECT CONCERNS ABOUT BIAS IN 

2972
02:02:03,606 --> 02:02:05,007
THIS CASE.

2973
02:02:05,007 --> 02:02:08,110
THE SECOND EXAMPLE FOR A DRUG 

2974
02:02:08,110 --> 02:02:16,552
USE IN THE TREATMENT OF 

2975
02:02:16,552 --> 02:02:18,387
COVID-19 TOCILIZUMAB, TREATMENT 

2976
02:02:18,387 --> 02:02:23,392
IN ADDITION TO CORTICOSTEROIDS 

2977
02:02:23,392 --> 02:02:26,295
AND REQUIRING SUPPLEMENTAL 

2978
02:02:26,295 --> 02:02:28,998
OXYGEN, NON-INVASIVE OR 

2979
02:02:28,998 --> 02:02:31,467
INVASIVE MECHANICAL VENTILATION 

2980
02:02:31,467 --> 02:02:40,776
OR EXTRA  CORPOREAL MEMBRANE 

2981
02:02:40,776 --> 02:02:41,477
OXYGENATION.

2982
02:02:41,477 --> 02:02:44,980
THE SORT OF REAL-WORLD DATA 

2983
02:02:44,980 --> 02:02:47,516
COMPONENT OF THE RCT, THE 

2984
02:02:47,516 --> 02:02:49,585
PRIMARY ENDPOINT WAS OBTAINED 

2985
02:02:49,585 --> 02:02:52,087
FROM NATIONAL DEATH RECORDS.

2986
02:02:52,087 --> 02:02:55,257
THEN THE LAST ONE WAS A SAFETY 

2987
02:02:55,257 --> 02:02:58,828
RELATED ISSUE FOR LACOSAMIDE, 

2988
02:02:58,828 --> 02:03:04,066
WHICH IS USED FOR SEIZURES.

2989
02:03:04,066 --> 02:03:08,204
THE POINT HERE WAS TO PROPOSE 

2990
02:03:08,204 --> 02:03:12,341
ALTERNATE LOADING DOSE FOR 

2991
02:03:12,341 --> 02:03:13,409
INITIATION OF LACOSAMIDE 

2992
02:03:13,409 --> 02:03:18,180
TREATMENT IN PARTIAL ON SET 

2993
02:03:18,180 --> 02:03:20,883
SEIZURE FOR PATIENTS IN DHIRN.

2994
02:03:20,883 --> 02:03:27,490
THE ALTERNATE DOSES PRESENTED NO

2995
02:03:27,490 --> 02:03:31,060
 ADVERSE EVENTS SO THAT LED TO 

2996
02:03:31,060 --> 02:03:32,928
THE CHANGE IN THE LOAD AND DOSE 

2997
02:03:32,928 --> 02:03:35,464
IN THAT PRODUCT.

2998
02:03:35,464 --> 02:03:38,200
AND USE FOR ELECTRONIC HEALTH 

2999
02:03:38,200 --> 02:03:39,668
RECORDS.

3000
02:03:39,668 --> 02:03:43,005
THERE ARE SEVERAL CHALLENGES 

3001
02:03:43,005 --> 02:03:43,839
WITH REAL-WORLD EVIDENCE.

3002
02:03:43,839 --> 02:03:45,708
YOU DON'T HAVE TIME TO GO INTO 

3003
02:03:45,708 --> 02:03:48,244
ALL OF THEM, I THINK THE LAST 

3004
02:03:48,244 --> 02:03:49,144
PRESENTER COULD HAVED SOME OF 

3005
02:03:49,144 --> 02:03:50,746
THESE WELL.

3006
02:03:50,746 --> 02:03:53,682
DATA RELIABILITY AND CLINICAL 

3007
02:03:53,682 --> 02:03:55,084
RELEVANCE AND IT'S REALLY ON 

3008
02:03:55,084 --> 02:03:56,385
THE SPONSOR TO DEMONSTRATE THIS 

3009
02:03:56,385 --> 02:03:58,821
TO THE AGENCY.

3010
02:03:58,821 --> 02:04:01,590
SOMETIMES, YOU KNOW, IT MAY BE 

3011
02:04:01,590 --> 02:04:03,225
NOT EASY TO DEMONSTRATE 

3012
02:04:03,225 --> 02:04:05,494
RELIABILITY IN THE ABSENCE OF 

3013
02:04:05,494 --> 02:04:06,695
THRESHOLD OR MEASURES OF WHAT 

3014
02:04:06,695 --> 02:04:08,163
IS GOOD ENOUGH, AND THAT IS 

3015
02:04:08,163 --> 02:04:10,633
SOMETHING WE ARE EXPLORING.

3016
02:04:10,633 --> 02:04:12,334
THE POSSIBILITY TO ACTUALLY 

3017
02:04:12,334 --> 02:04:15,471
CAPTURE THE OUTCOME AND DATA 

3018
02:04:15,471 --> 02:04:17,506
SOURCE, IF NOT, CHALLENGES WITH 

3019
02:04:17,506 --> 02:04:19,208
LINKAGE FOR OTHER DATA SOURCES 

3020
02:04:19,208 --> 02:04:21,844
CAN BE PROBLEMATIC IN TERMS OF 

3021
02:04:21,844 --> 02:04:23,345
GETTING PATIENT CONSENT IF 

3022
02:04:23,345 --> 02:04:24,146
THAT'S NOT ACHIEVED BEFORE.

3023
02:04:24,146 --> 02:04:26,815
AND THE COST OF THESE THINGS.

3024
02:04:26,815 --> 02:04:31,520
IN TERMS OF DESIGN AND 

3025
02:04:31,520 --> 02:04:33,389
INTERPRETATION, CONFOUNDING IS 

3026
02:04:33,389 --> 02:04:35,558
FREQUENTLY INITIATED IN 

3027
02:04:35,558 --> 02:04:37,493
NON-RANDOMIZED STUDIES.

3028
02:04:37,493 --> 02:04:39,461
PROBLEMS WITH INAPPROPRIATE 

3029
02:04:39,461 --> 02:04:49,338
SPECIFICATION OF THE ENDPOINT.

3030
02:04:49,338 --> 02:04:52,608
USING NON-COMPARATOR.

3031
02:04:52,608 --> 02:04:54,209
FOR US, CONDUCT IS VERY 

3032
02:04:54,209 --> 02:04:55,544
IMPORTANT.

3033
02:04:55,544 --> 02:04:57,813
MAKING SURE EVERYTHING IS 

3034
02:04:57,813 --> 02:04:59,248
PRE-SPECIFIED AND FULLY 

3035
02:04:59,248 --> 02:05:01,116
REVIEWED BY REVIEW TEAM AT FDA 

3036
02:05:01,116 --> 02:05:02,751
IS REALLY A MAJOR CONCERN FOR 

3037
02:05:02,751 --> 02:05:04,286
US.

3038
02:05:04,286 --> 02:05:10,292
ALSO THAT, NO ONE ELSE UNTIL 

3039
02:05:10,292 --> 02:05:12,761
APPROVAL HAS BEEN APPROVED AND 

3040
02:05:12,761 --> 02:05:14,196
ACCESS TO PATIENT-LEVEL DATA 

3041
02:05:14,196 --> 02:05:17,566
AND ABILITY TO INSPECT 

3042
02:05:17,566 --> 02:05:19,201
REAL-WORLD DATA SOURCES IS A 

3043
02:05:19,201 --> 02:05:20,502
MAJOR CONCERN AND COULD BE 

3044
02:05:20,502 --> 02:05:22,705
CHALLENGING FOR A SPONSOR WHO 

3045
02:05:22,705 --> 02:05:25,007
POTENTIALLY DOESN'T OWN THAT 

3046
02:05:25,007 --> 02:05:25,207
DATA.

3047
02:05:25,207 --> 02:05:27,876
I WANTED TO MOVE ONTO SOME 

3048
02:05:27,876 --> 02:05:33,415
SPECIFIC CHALLENGES RELATED TO 

3049
02:05:33,415 --> 02:05:36,185
THE DIABETES AND OBESITY SPACE.

3050
02:05:36,185 --> 02:05:38,787
IF YOU ARE USING HEALTH CARE 

3051
02:05:38,787 --> 02:05:41,090
CLAIMS DATA, BUT THERE ARE 

3052
02:05:41,090 --> 02:05:43,525
SPECIFIC CHALLENGES IN THIS 

3053
02:05:43,525 --> 02:05:49,198
AREA, MEASURE CONFOUNDING 

3054
02:05:49,198 --> 02:05:52,534
PARTICULARLY BMI, DIABETES 

3055
02:05:52,534 --> 02:05:53,602
SEVERITY, HBA1C OFTEN CLAIMS 

3056
02:05:53,602 --> 02:05:55,337
THEY DIDN'T HAVE ACCESS TO 

3057
02:05:55,337 --> 02:05:56,939
LABORATORY DATA.

3058
02:05:56,939 --> 02:05:59,408
THERE IS LIKE A PROXY FOR 

3059
02:05:59,408 --> 02:06:02,945
DIABETES SEVERITY AND ADAPTED 

3060
02:06:02,945 --> 02:06:04,647
DIABETES SEVERITY INDEX YOU CAN 

3061
02:06:04,647 --> 02:06:08,984
GUILT   --  GET FROM CLAIMS 

3062
02:06:08,984 --> 02:06:12,588
DATA BUT ONLY A PROXY.

3063
02:06:12,588 --> 02:06:14,890
THIS GLP-1 AREA CAN BE VERY 

3064
02:06:14,890 --> 02:06:16,558
DIFFICULT TO IDENTIFY THE 

3065
02:06:16,558 --> 02:06:18,594
INDICATION FOR GLP-1 USE, 

3066
02:06:18,594 --> 02:06:20,696
ESPECIALLY IF IT'S WEIGHT LOSS.

3067
02:06:20,696 --> 02:06:23,399
IT'S VERY DIFFICULT TO IDENTIFY 

3068
02:06:23,399 --> 02:06:26,268
INDICATION IN CLAIMS DATA, BUT 

3069
02:06:26,268 --> 02:06:27,569
SOMETHING LIKE DIABETES IS A 

3070
02:06:27,569 --> 02:06:30,906
LITTLE BIT EASIER TO ASSUME AND 

3071
02:06:30,906 --> 02:06:35,477
TRY TO IDENTIFY OBESITY THE AND 

3072
02:06:35,477 --> 02:06:36,278
DIAGNOSIS CODES LACKS 

3073
02:06:36,278 --> 02:06:39,581
SENSITIVITY.

3074
02:06:39,581 --> 02:06:41,283
THERE ISN'T ANOTHER CHRONIC 

3075
02:06:41,283 --> 02:06:42,918
WEIGHT MANAGEMENT PRODUCT THAT 

3076
02:06:42,918 --> 02:06:46,889
IS A SUITABLE COMPARATOR FOR A 

3077
02:06:46,889 --> 02:06:48,891
STUDY IN GLP-1'S AND NOT POSE 

3078
02:06:48,891 --> 02:06:50,826
AS CHALLENGES IF YOU WANT TO DO 

3079
02:06:50,826 --> 02:06:54,096
STUDIES IN THE WEIGHT LOSS 

3080
02:06:54,096 --> 02:06:54,396
POPULATION.

3081
02:06:54,396 --> 02:06:55,631
BECAUSE OBVIOUSLY, IF YOU ARE 

3082
02:06:55,631 --> 02:06:57,132
USING A NON-USER GROUP THEY 

3083
02:06:57,132 --> 02:06:58,333
COULD BE VERY DIFFERENT AND 

3084
02:06:58,333 --> 02:07:00,235
COULD LEAD TO IMBALANCE AND 

3085
02:07:00,235 --> 02:07:01,904
SORT OF BASELINE 

3086
02:07:01,904 --> 02:07:02,905
CHARACTERISTICS BETWEEN THE TWO 

3087
02:07:02,905 --> 02:07:04,206
GROUPS.

3088
02:07:04,206 --> 02:07:06,508
NEXT I JUST WANT TO TALK 

3089
02:07:06,508 --> 02:07:08,377
BRIEFLY ABOUT SOME STUDIES THAT 

3090
02:07:08,377 --> 02:07:12,514
FDA HAVE DONE IN THE SENTINEL 

3091
02:07:12,514 --> 02:07:14,183
SYSTEM, A LONG DISTRIBUTOR 

3092
02:07:14,183 --> 02:07:16,485
NETWORK THAT IS FOCUSED ON SORT 

3093
02:07:16,485 --> 02:07:18,187
OF ACTIVE SURVEILLANCE OF 

3094
02:07:18,187 --> 02:07:19,254
APPROVED PRODUCTS IN MONITORING 

3095
02:07:19,254 --> 02:07:20,089
SAFETY.

3096
02:07:20,089 --> 02:07:23,192
THIS WAS ACTUALLY A TREE SCAN 

3097
02:07:23,192 --> 02:07:24,293
BASE SIGNAL IDENTIFICATION 

3098
02:07:24,293 --> 02:07:34,970
STUDY DONE FOR  OZEMPIC BETWEEN 

3099
02:07:34,970 --> 02:07:38,640
JANUARY 2018 AND FEBRUARY 2022.

3100
02:07:38,640 --> 02:07:42,945
COMPARED TO ANOTHER DIABETES 

3101
02:07:42,945 --> 02:07:53,055
AGENT.

3102
02:07:53,956 --> 02:07:58,727
THEY HAD 134 MATCHED PAIRS WITH 

3103
02:07:58,727 --> 02:08:02,231
CONVENTIONAL AND SLIGHTLY LESS 

3104
02:08:02,231 --> 02:08:09,571
ON THE SCORE METHODS.

3105
02:08:09,571 --> 02:08:11,907
SEMAGLUTIDE USERS YOUNGER HAD A 

3106
02:08:11,907 --> 02:08:14,409
LOT MORE HEALTH CARE 

3107
02:08:14,409 --> 02:08:16,712
UTILIZATION AND HISTORY OF 

3108
02:08:16,712 --> 02:08:19,615
OBESITY AND INSULIN USE.

3109
02:08:19,615 --> 02:08:21,517
THEY WERE EITHER LABELED 

3110
02:08:21,517 --> 02:08:24,653
ADVERSE EVENTS LIKE NAUSEA, 

3111
02:08:24,653 --> 02:08:25,154
VOMITING, CONSTIPATION, 

3112
02:08:25,154 --> 02:08:26,355
DIARRHEA.

3113
02:08:26,355 --> 02:08:29,458
THERE WERE NO NEW SAFETY 

3114
02:08:29,458 --> 02:08:32,961
SIGNALS FOR OZEMPIC AND MORE 

3115
02:08:32,961 --> 02:08:34,797
LIKELY CO MORBID AND NONE OF 

3116
02:08:34,797 --> 02:08:35,497
THE ALERTS REQUIRED FURTHER 

3117
02:08:35,497 --> 02:08:37,499
FOLLOW-UP.

3118
02:08:37,499 --> 02:08:39,301
I KNOW I'M GOING A BIT OVER 

3119
02:08:39,301 --> 02:08:40,936
TIME HERE.

3120
02:08:40,936 --> 02:08:43,939
FDA ARE CURRENTLY INTERESTED IN 

3121
02:08:43,939 --> 02:08:47,309
THE RISK OF INTENTIONAL 

3122
02:08:47,309 --> 02:08:48,544
SELF-HARM WITH GLP-1 DRUGS.

3123
02:08:48,544 --> 02:08:51,680
THERE ARE TWO STUDIES ONGOING, 

3124
02:08:51,680 --> 02:08:54,516
DESCRIPTIVE ANALYSIS THAT 

3125
02:08:54,516 --> 02:08:59,354
LOOKED AT UNADJUSTED RATES OF 

3126
02:08:59,354 --> 02:09:01,857
INTENTIONAL SELF-HARM AMONG 

3127
02:09:01,857 --> 02:09:06,261
ADULT USERS BETWEEN 2015-2023 

3128
02:09:06,261 --> 02:09:09,731
TO GET IDEA OF PSYCH HISTORY, 

3129
02:09:09,731 --> 02:09:10,332
PSYCHOLOGICAL DISORDERS, 

3130
02:09:10,332 --> 02:09:12,701
MEDICAL HISTORY AND HEALTH CARE 

3131
02:09:12,701 --> 02:09:15,571
UTILIZATION AMONG THOSE WITH 

3132
02:09:15,571 --> 02:09:17,573
OBESITY, RECEIVING ANY WEIGHT 

3133
02:09:17,573 --> 02:09:21,543
LOSS PRODUCT.

3134
02:09:21,543 --> 02:09:24,046
THE INFERENTIAL STUDY UNDER WAY 

3135
02:09:24,046 --> 02:09:25,280
WAS EVALUATING THE ASSOCIATION 

3136
02:09:25,280 --> 02:09:30,719
BETWEEN THE USE OF GLP-1'S AND 

3137
02:09:30,719 --> 02:09:33,589
POTENTIAL SELF-HARM AND USERS 

3138
02:09:33,589 --> 02:09:39,161
OF OTHER DIABETES DRUGS.

3139
02:09:39,161 --> 02:09:44,600
INCIDENT USERS WITH TYPE II 

3140
02:09:44,600 --> 02:09:46,268
DIABETES BETWEEN 2015-2023.

3141
02:09:46,268 --> 02:09:48,704
AND SECONDARY POPULATION CO 

3142
02:09:48,704 --> 02:09:50,305
MORBID TYPE II DIABETES AND 

3143
02:09:50,305 --> 02:09:52,808
OBESITY.

3144
02:09:52,808 --> 02:09:57,212
INTENTIONAL SELF-HARM 

3145
02:09:57,212 --> 02:09:59,948
IDENTIFIED USING SENTINEL.

3146
02:09:59,948 --> 02:10:07,990
INVERSE PROBABILITY USING 

3147
02:10:07,990 --> 02:10:09,725
ICD-10 DIAGNOSIS CODES.

3148
02:10:09,725 --> 02:10:11,994
AND INVERSE PROBABILITY OF 

3149
02:10:11,994 --> 02:10:14,263
TREATMENT WEIGHTING TO ADJUST 

3150
02:10:14,263 --> 02:10:14,763
FOR CONFOUNDING.

3151
02:10:14,763 --> 02:10:16,398
THESE STUDIES AREN'T AVAILABLE 

3152
02:10:16,398 --> 02:10:18,267
YET SO UNFORTUNATELY I DON'T 

3153
02:10:18,267 --> 02:10:19,701
HAVE THAT INFORMATION TO SHARE, 

3154
02:10:19,701 --> 02:10:21,203
BUT SURELY THEY WILL BE OUT 

3155
02:10:21,203 --> 02:10:23,705
SOON ENOUGH, SO PLEASE KEEP AN 

3156
02:10:23,705 --> 02:10:25,040
EYE OUT FOR THEM.

3157
02:10:25,040 --> 02:10:28,443
IN SUMMARY OUR PROGRAM IS 

3158
02:10:28,443 --> 02:10:31,713
ADVANCING AS OUTLINED IN OUR 

3159
02:10:31,713 --> 02:10:33,782
FRAMEWORK, GUIDANCE AND OTHER 

3160
02:10:33,782 --> 02:10:35,250
INTERESTED PARTIES ARE 

3161
02:10:35,250 --> 02:10:37,352
INTERESTED IN CURRENT 

3162
02:10:37,352 --> 02:10:40,022
CHALLENGES AND CHALLENGE WITH 

3163
02:10:40,022 --> 02:10:44,993
GENERATING REAL-WORLD EVIDENCE, 

3164
02:10:44,993 --> 02:10:48,497
CDER AND CCRI IS CONTINUING TO 

3165
02:10:48,497 --> 02:10:50,966
ADVANCE THE USE OF RWE AND 

3166
02:10:50,966 --> 02:10:53,735
DRIVE-IN NOVATION IN THE SPACE.

3167
02:10:53,735 --> 02:10:54,970
HOPEFULLY THE RESULTS WILL BE 

3168
02:10:54,970 --> 02:10:56,271
AVAILABLE SOON.

3169
02:10:56,271 --> 02:11:01,043
I WANT TO ACKNOWLEDGE MY TEAM 

3170
02:11:01,043 --> 02:11:02,811
AND ANALYTIC TEAM AND 

3171
02:11:02,811 --> 02:11:04,479
COLLEAGUES IN DIVISION OF 

3172
02:11:04,479 --> 02:11:08,850
EPIDEMIOLOGY AND DIVISION OF 

3173
02:11:08,850 --> 02:11:10,652
PHARMACOVIGILANCE AND OFFICE OF 

3174
02:11:10,652 --> 02:11:12,821
SURVEILLANCE WITH HELP WITH THE 

3175
02:11:12,821 --> 02:11:13,055
SLIDES.

3176
02:11:13,055 --> 02:11:16,658
SO THANK YOU SO MUCH.

3177
02:11:16,658 --> 02:11:18,560
WE HAVE REAL-WORLD EVIDENCE 

3178
02:11:18,560 --> 02:11:20,329
MAILBOX IN MY CENTER.

3179
02:11:20,329 --> 02:11:21,897
SO IF ANYONE HAS ANY QUESTIONS 

3180
02:11:21,897 --> 02:11:25,067
YOU CAN OF COURSE ASK ME OR 

3181
02:11:25,067 --> 02:11:27,936
REACH OUT VIA OUR EMAIL HERE.

3182
02:11:27,936 --> 02:11:32,140
THANK YOU FOR YOUR TIME.

3183
02:11:32,140 --> 02:11:34,209
>> CHRISTINE WEE: THANK
YOU 

3184
02:11:34,209 --> 02:11:34,476
VERY MUCH.

3185
02:11:34,476 --> 02:11:36,311
OUR NEXT TWO PRESENTERS WILL 

3186
02:11:36,311 --> 02:11:39,014
SPEAK ON ASSESSING STRENGTH OF 

3187
02:11:39,014 --> 02:11:40,349
REAL-WORLD EVIDENCE FOR 

3188
02:11:40,349 --> 02:11:40,983
PRACTICE AND GUIDELINES 

3189
02:11:40,983 --> 02:11:42,351
DEVELOPMENT.

3190
02:11:42,351 --> 02:11:44,286
DR. JOHN WONG IS CHAIR FOR 

3191
02:11:44,286 --> 02:11:46,054
ACADEMIC AFFAIRS CHIEF OF DLIN 

3192
02:11:46,054 --> 02:11:51,126
CAL DECISION MAKING AND PRIMARY 

3193
02:11:51,126 --> 02:11:53,362
CARE INTERNIST AT TUFTS MEDICAL 

3194
02:11:53,362 --> 02:11:55,897
CENTER AND VICE CHAIR TASK 

3195
02:11:55,897 --> 02:11:59,601
FORCE, AND EDITOR FOR RESEARCH 

3196
02:11:59,601 --> 02:12:06,108
ANNALS OF INTERNAL MEDICINE.

3197
02:12:06,108 --> 02:12:12,114
USING DECISION  ANALYSIS.

3198
02:12:12,114 --> 02:12:15,617
JOINED BY DR. ASHLEY SKINNER, 

3199
02:12:15,617 --> 02:12:17,953
HEALTH ANALYSIS RESEARCHER AND 

3200
02:12:17,953 --> 02:12:19,254
POPULATION HEALTH SCIENCES AT 

3201
02:12:19,254 --> 02:12:20,622
DUKE UNIVERSITY.

3202
02:12:20,622 --> 02:12:24,860
SHE A RECOGNIZED EXPERT IN 

3203
02:12:24,860 --> 02:12:27,562
OBESITY AND CONTRIBUTED TO THE 

3204
02:12:27,562 --> 02:12:31,299
AMERICAN ACADEMY PEDIATRIC 

3205
02:12:31,299 --> 02:12:34,202
WHICH HAS HELPED SHAPE STANDARD 

3206
02:12:34,202 --> 02:12:36,571
FOR CARE IN PEDIATRIC OBESITY.

3207
02:12:36,571 --> 02:12:39,441
WE WILL START WITH DR. JOHN 

3208
02:12:39,441 --> 02:12:42,978
WONG FOLLOWED BY DR. SKINNER.

3209
02:12:42,978 --> 02:12:49,584
>> JOHN WONG: THANKS, DR.
WEE.

3210
02:12:49,584 --> 02:12:53,789
BUILDING ON THE EXCELLENT TALKS 

3211
02:12:53,789 --> 02:12:55,891
ABOUT THE STRENGTHS AND 

3212
02:12:55,891 --> 02:12:57,959
LIMITATIONS OF RANDOMIZED 

3213
02:12:57,959 --> 02:12:59,194
VERSUS NON-RANDOMIZED EVIDENCE 

3214
02:12:59,194 --> 02:13:01,430
AND HOW IT INFORMS REGULATORY 

3215
02:13:01,430 --> 02:13:02,164
DECISIONS.

3216
02:13:02,164 --> 02:13:03,799
I'M HOPING TO SPEAK BRIEFLY 

3217
02:13:03,799 --> 02:13:05,867
WITH YOU ALL ABOUT HOW THE 

3218
02:13:05,867 --> 02:13:09,438
TRANSLATION OF THAT EVIDENCE 

3219
02:13:09,438 --> 02:13:11,540
INTO RECOMMENDATIONS FOR 

3220
02:13:11,540 --> 02:13:13,442
CLINICAL CARE PRACTICE VARIES, 

3221
02:13:13,442 --> 02:13:16,578
SO THAT YOU CAN COMPARE AND 

3222
02:13:16,578 --> 02:13:18,013
CONTRAST THE IMPLICATIONS AND 

3223
02:13:18,013 --> 02:13:18,780
STRENGTHS AND LIMITATIONS OF 

3224
02:13:18,780 --> 02:13:19,681
THAT.

3225
02:13:19,681 --> 02:13:22,150
I HAVE NO FINANCIAL 

3226
02:13:22,150 --> 02:13:23,185
DISCLOSURES, AS MENTIONED I'M A 

3227
02:13:23,185 --> 02:13:25,087
VICE CHAIR OF PREVENTIVE 

3228
02:13:25,087 --> 02:13:26,254
SERVICES TASK FORCE, THIS 

3229
02:13:26,254 --> 02:13:27,122
PRESENTATION DOES NOT 

3230
02:13:27,122 --> 02:13:29,191
NECESSARILY REPRESENT THE 

3231
02:13:29,191 --> 02:13:29,825
VIEWS, PROCESSES, 

3232
02:13:29,825 --> 02:13:31,960
RECOMMENDATIONS AND POLICIES OF 

3233
02:13:31,960 --> 02:13:36,031
THE USPSTF.

3234
02:13:36,031 --> 02:13:39,568
NOR DO THE VIEWS EXPRESS IN 

3235
02:13:39,568 --> 02:13:41,036
THIS PRESENTATION, THEY SHOULD 

3236
02:13:41,036 --> 02:13:45,807
NOT BE CONSTRUED AS OFFICIAL 

3237
02:13:45,807 --> 02:13:48,710
POSITION OF AHRQ OR DEPARTMENT 

3238
02:13:48,710 --> 02:13:51,580
OF HEALTH AND HUMAN SERVICES.

3239
02:13:51,580 --> 02:13:55,317
WE ARE SCIENTIFICALLY 

3240
02:13:55,317 --> 02:13:58,086
INDEPENDENT GROUP OF VOLUNTEERS.

3241
02:13:58,086 --> 02:13:59,921
WE HAVE EXPERIENCE AND 

3242
02:13:59,921 --> 02:14:01,756
EXPERTISE IN PRIMARY CARE, 

3243
02:14:01,756 --> 02:14:04,459
DISEASE PREVENTION AND 

3244
02:14:04,459 --> 02:14:04,960
EVIDENCE-BASED MEDICINE.

3245
02:14:04,960 --> 02:14:06,761
WE MAKE RECOMMENDATIONS ABOUT 

3246
02:14:06,761 --> 02:14:08,797
PREVENTIVE SERVICES, SCREENING, 

3247
02:14:08,797 --> 02:14:10,065
COUNSELING AND PREVENTIVE 

3248
02:14:10,065 --> 02:14:11,533
MEDICATIONS FOR PEOPLE WITHOUT 

3249
02:14:11,533 --> 02:14:13,235
SYMPTOMS OR SIGNS OF DISEASE.

3250
02:14:13,235 --> 02:14:14,469
OUR MISSION AND WORK IS TO 

3251
02:14:14,469 --> 02:14:16,771
IMPROVE THE HEALTH OF PEOPLE 

3252
02:14:16,771 --> 02:14:19,241
NATIONWIDE OF

3253
02:14:19,241 --> 02:14:21,309
BRIEFLY OUR DEVELOPMENT PROCESS 

3254
02:14:21,309 --> 02:14:23,178
CONSISTS OF REVIEWING TOPIC 

3255
02:14:23,178 --> 02:14:24,613
NOMINATION WHICH COULD BE 

3256
02:14:24,613 --> 02:14:25,814
SUBMITTED BY ANYONE, ANY 

3257
02:14:25,814 --> 02:14:27,249
PERSON, OR ORGANIZATION.

3258
02:14:27,249 --> 02:14:28,884
WE PRIORITIZE THOSE NOMINATIONS 

3259
02:14:28,884 --> 02:14:32,621
AND WORKING WITH OUR AHRQ 

3260
02:14:32,621 --> 02:14:34,689
EVIDENCE BASED REVIEW TEAMS WE 

3261
02:14:34,689 --> 02:14:36,191
DRAFT A RESEARCH PLAN THAT THEN 

3262
02:14:36,191 --> 02:14:39,294
GOES OUT FOR PUBLIC COMMENT.

3263
02:14:39,294 --> 02:14:41,229
ANYONE, ANY ORGANIZATION CAN 

3264
02:14:41,229 --> 02:14:43,031
MAKE COMMENTS.

3265
02:14:43,031 --> 02:14:45,500
WE REVIEW EACH AND EVERY ONE OF 

3266
02:14:45,500 --> 02:14:47,202
THOSE COMMENTS AND FINALIZE OUR 

3267
02:14:47,202 --> 02:14:48,803
RESEARCH PLAN.

3268
02:14:48,803 --> 02:14:50,038
THE EVIDENCE-BASED PRACTICE 

3269
02:14:50,038 --> 02:14:51,940
CENTER THEN GOES OUT AND DOES 

3270
02:14:51,940 --> 02:14:53,308
THE EVIDENCE SEARCH AND RETURNS 

3271
02:14:53,308 --> 02:14:55,677
IT BACK TO THE TASK FORCE.

3272
02:14:55,677 --> 02:14:58,213
THE TASK FORCE THEN REVIEWS THE 

3273
02:14:58,213 --> 02:15:00,916
EVIDENCE AND DEVELOPS DRAFT 

3274
02:15:00,916 --> 02:15:01,783
RECOMMENDATIONS STATEMENT, THAT 

3275
02:15:01,783 --> 02:15:03,652
AGAIN, GOES OUT FOR PUBLIC 

3276
02:15:03,652 --> 02:15:04,953
COMMENT.

3277
02:15:04,953 --> 02:15:07,189
AND AGAIN, WE READ EACH AND 

3278
02:15:07,189 --> 02:15:11,026
EVERY SINGLE PUBLIC COMMENT AND 

3279
02:15:11,026 --> 02:15:11,993
REVISE RECOMMENDATION STATEMENT 

3280
02:15:11,993 --> 02:15:14,930
AND IN FACT HAVE A SEPARATE 

3281
02:15:14,930 --> 02:15:17,232
SECTION ABOUT IT IN OUR FINAL 

3282
02:15:17,232 --> 02:15:19,301
SUBMISSION THAT IS SUBMITTED 

3283
02:15:19,301 --> 02:15:25,373
BOTH PUBLICLY FROM THE AHRQ WIB 

3284
02:15:25,373 --> 02:15:28,677
 WEBSITE OR JAMA.

3285
02:15:28,677 --> 02:15:31,780
THE USPSTF IS AN EXEMPLAR 

3286
02:15:31,780 --> 02:15:35,684
EXAMPLE NATIONAL ACADEMIES 

3287
02:15:35,684 --> 02:15:38,420
MEDICINE 2011 RECOMMENDATION 

3288
02:15:38,420 --> 02:15:42,224
FOR GUIDELINE PROCESSES, CALLED 

3289
02:15:42,224 --> 02:15:43,091
CLINICAL GUIDELINES WE CAN 

3290
02:15:43,091 --> 02:15:44,426
TRUST.

3291
02:15:44,426 --> 02:15:45,894
WHAT DO OUR RECOMMENDATION 

3292
02:15:45,894 --> 02:15:47,062
GRADES LOOK LIKE?

3293
02:15:47,062 --> 02:15:50,832
THEY DEPEND ON TWO ELEMENTS.

3294
02:15:50,832 --> 02:15:52,968
THE FIRST IS CERTAINTY FROM LOW 

3295
02:15:52,968 --> 02:15:53,702
TO HIGH.

3296
02:15:53,702 --> 02:15:55,337
I WANT TO HIGHLIGHT YOU CAN 

3297
02:15:55,337 --> 02:15:56,805
ONLY HAVE MODERATE OR HIGH 

3298
02:15:56,805 --> 02:15:59,908
CERTAINTY IF YOU HAVE RCT 

3299
02:15:59,908 --> 02:16:01,109
EVIDENCE THAT AFFECTS A HEALTH 

3300
02:16:01,109 --> 02:16:01,776
OUTCOME.

3301
02:16:01,776 --> 02:16:03,712
I WILL SAY A WORD ABOUT THAT IN 

3302
02:16:03,712 --> 02:16:05,347
THE NEXT SLIDE.

3303
02:16:05,347 --> 02:16:07,048
THE OTHER DIMENSION IS THE 

3304
02:16:07,048 --> 02:16:08,516
MAGNITUDE OF NET BENEFIT.

3305
02:16:08,516 --> 02:16:10,085
WE ARE CONSIDERING THE 

3306
02:16:10,085 --> 02:16:11,186
POPULATION BENEFIT VERSUS THE 

3307
02:16:11,186 --> 02:16:13,788
POPULATION HARM.

3308
02:16:13,788 --> 02:16:16,091
AND IF THAT NET BENEFIT IS 

3309
02:16:16,091 --> 02:16:17,559
EITHER SUBSTANTIAL OR MODERATE, 

3310
02:16:17,559 --> 02:16:20,328
WE GIVE IT AN A OR B 

3311
02:16:20,328 --> 02:16:21,129
RECOMMENDATION GRADE.

3312
02:16:21,129 --> 02:16:23,398
AND YOU CAN THINK OF THAT AS 

3313
02:16:23,398 --> 02:16:24,266
BASICALLY SOMETHING THAT SHOULD 

3314
02:16:24,266 --> 02:16:28,036
BE DONE  AT THE POPULATION 

3315
02:16:28,036 --> 02:16:28,236
LEVEL.

3316
02:16:28,236 --> 02:16:29,671
WE HAVE AT LEAST MODERATE 

3317
02:16:29,671 --> 02:16:32,841
CERTAINTY, OF AT LEAST MODERATE 

3318
02:16:32,841 --> 02:16:34,576
MAGNITUDE OF NET BENEFIT.

3319
02:16:34,576 --> 02:16:37,545
GENERALLY THAT SHOULD BE 

3320
02:16:37,545 --> 02:16:38,613
INCORPORATED INTO CLINICAL 

3321
02:16:38,613 --> 02:16:39,180
DECISIONS.

3322
02:16:39,180 --> 02:16:41,516
IF THE NET BENEFIT IS SMALL, WE 

3323
02:16:41,516 --> 02:16:43,051
GIVE IT A GRADE OF C.

3324
02:16:43,051 --> 02:16:45,520
YOU COULD THINK OF THE C AS A 

3325
02:16:45,520 --> 02:16:48,823
CHOICE IN WHICH A CLINICIAN 

3326
02:16:48,823 --> 02:16:50,692
EXPLAINS THE OPTIONS AND THE 

3327
02:16:50,692 --> 02:16:53,595
PATIENT SHARES THEIR 

3328
02:16:53,595 --> 02:16:54,863
PREFERENCES AND VALUES, AND 

3329
02:16:54,863 --> 02:16:56,531
TOGETHER MAKE A DECISION 

3330
02:16:56,531 --> 02:16:57,732
THROUGH SHARED DECISION MAKING 

3331
02:16:57,732 --> 02:17:00,101
AS TO WHETHER OR NOT THAT 

3332
02:17:00,101 --> 02:17:00,969
PREVENTIVE INTERVENTION IS 

3333
02:17:00,969 --> 02:17:02,170
APPROPRIATE FOR THEM.

3334
02:17:02,170 --> 02:17:04,306
IF THE NET BENEFIT IS EITHER 

3335
02:17:04,306 --> 02:17:07,442
ZERO OR NEGATIVE WE GIVE IT A D 

3336
02:17:07,442 --> 02:17:08,643
GRADE.

3337
02:17:08,643 --> 02:17:14,649
CAN THINK OF "D" AS "DON'T".

3338
02:17:14,649 --> 02:17:18,420
WITH LOW DEGREE, THAT'S AN I 

3339
02:17:18,420 --> 02:17:18,687
STATEMENT.

3340
02:17:18,687 --> 02:17:20,088
BASICALLY INDICATES THERE'S 

3341
02:17:20,088 --> 02:17:21,556
INSUFFICIENT EVIDENCE, IT'S 

3342
02:17:21,556 --> 02:17:24,059
STILL AN IMPORTANT INTERVENTION 

3343
02:17:24,059 --> 02:17:26,695
AND NOT FOR OR AGAINST, WE JUST 

3344
02:17:26,695 --> 02:17:28,396
DON'T HAVE ENOUGH EVIDENCE TO 

3345
02:17:28,396 --> 02:17:30,131
MAKE A RECOMMENDATION.

3346
02:17:30,131 --> 02:17:32,033
AND BASICALLY IT'S A CALL FOR 

3347
02:17:32,033 --> 02:17:33,935
FURTHER RESEARCH.

3348
02:17:33,935 --> 02:17:36,571
A WORD ABOUT HEALTH VERSUS 

3349
02:17:36,571 --> 02:17:38,073
INTERMEDIATE OUTCOMES.

3350
02:17:38,073 --> 02:17:40,208
A HEALTH OUTCOME FOR THE TASK 

3351
02:17:40,208 --> 02:17:41,609
FORCE INVOLVES SYMPTOMS, 

3352
02:17:41,609 --> 02:17:42,644
FUNCTIONAL LEVELS AND 

3353
02:17:42,644 --> 02:17:44,746
CONDITIONS THAT PATIENTS CAN 

3354
02:17:44,746 --> 02:17:47,615
FEEL OR EXPERIENCE AND ARE 

3355
02:17:47,615 --> 02:17:50,719
DEFINED BY MEASURES OF PHYSICAL 

3356
02:17:50,719 --> 02:17:54,022
OR PSYCHOLOGICAL WELL-BEING.

3357
02:17:54,022 --> 02:17:55,690
INTERMEDIATE OUTCOMES ARE 

3358
02:17:55,690 --> 02:17:58,827
PATHOLOGIC, OR PHYSIOLOGICAL, 

3359
02:17:58,827 --> 02:18:00,462
PSYCHOLOGICAL, SOCIAL OR 

3360
02:18:00,462 --> 02:18:02,330
BEHAVIOR MEASURES AND OTHER 

3361
02:18:02,330 --> 02:18:05,567
STUDY ENDPOINTS RELATED TO 

3362
02:18:05,567 --> 02:18:09,371
PREVENTIVE INTERVENTION.

3363
02:18:09,371 --> 02:18:12,273
EXAMPLES BLOOD PRESSURE, SERUM 

3364
02:18:12,273 --> 02:18:13,274
CHOLESTEROL OR WEIGHT.

3365
02:18:13,274 --> 02:18:15,143
I WANT TO HIGHLIGHT THE FACT 

3366
02:18:15,143 --> 02:18:17,178
THAT A PREVENTIVE SERVICE HAS A 

3367
02:18:17,178 --> 02:18:19,047
PROVEN EFFECT ON AN 

3368
02:18:19,047 --> 02:18:20,949
INTERMEDIATE OUTCOME DOES NOT 

3369
02:18:20,949 --> 02:18:22,817
NECESSARILY ESTABLISH THAT IT 

3370
02:18:22,817 --> 02:18:25,120
CAN IMPROVE OUTCOMES THAT ARE 

3371
02:18:25,120 --> 02:18:26,654
PERCEPTIBLE TO PATIENTS.

3372
02:18:26,654 --> 02:18:28,456
BECAUSE WE ARE FOCUSED ON 

3373
02:18:28,456 --> 02:18:30,325
PATIENTS WHO DON'T HAVE 

3374
02:18:30,325 --> 02:18:32,427
SYMPTOMS OR SIGNS, WE DON'T 

3375
02:18:32,427 --> 02:18:33,862
MAKE RECOMMENDATIONS FOR 

3376
02:18:33,862 --> 02:18:35,563
PATIENTS, SAY, WHO HAVE A 

3377
02:18:35,563 --> 02:18:36,498
PARTICULAR DISEASE, SUCH AS 

3378
02:18:36,498 --> 02:18:37,866
DIABETES.

3379
02:18:37,866 --> 02:18:40,702
WE VIEW THAT AS THE PURVIEW OF 

3380
02:18:40,702 --> 02:18:41,536
DISEASE MANAGEMENT 

3381
02:18:41,536 --> 02:18:43,438
ORGANIZATIONS SUCH AS THE 

3382
02:18:43,438 --> 02:18:44,305
AMERICAN DIABETES ASSOCIATION, 

3383
02:18:44,305 --> 02:18:48,009
FOR THOSE WHO HAVE TYPE I OR 

3384
02:18:48,009 --> 02:18:49,644
TYPE II DIABETES.

3385
02:18:49,644 --> 02:18:51,346
I WANT TO SHARE WITH YOU WHAT 

3386
02:18:51,346 --> 02:18:55,350
WE DID IN 2018, WHICH IS OUR 

3387
02:18:55,350 --> 02:18:56,384
LATEST RECOMMENDATION STATEMENT.

3388
02:18:56,384 --> 02:18:58,319
JUST AS AN EXAMPLE OF OUR 

3389
02:18:58,319 --> 02:19:01,222
PROCESSES AND PROCEED YOUS.

3390
02:19:01,222 --> 02:19:06,194
PROCEDURES.

3391
02:19:06,194 --> 02:19:07,796
BEHAVIORAL AND PHARMACOTHERAPY 

3392
02:19:07,796 --> 02:19:10,899
WEIGHT LOSS INTERVENTIONS TO 

3393
02:19:10,899 --> 02:19:11,566
PREVENT OBESITY-RELATED 

3394
02:19:11,566 --> 02:19:13,701
MORBIDITY AND MORTALITY IN 

3395
02:19:13,701 --> 02:19:13,935
ADULTS.

3396
02:19:13,935 --> 02:19:16,604
WE DO NOT ADDRESS THESE 

3397
02:19:16,604 --> 02:19:17,372
PHARMACOTHERAPY INTERVENTIONS 

3398
02:19:17,372 --> 02:19:18,540
FOR INDIVIDUALS WITH TYPE II 

3399
02:19:18,540 --> 02:19:20,475
DIABETES.

3400
02:19:20,475 --> 02:19:21,943
THIS PARTICULAR EVIDENCE 

3401
02:19:21,943 --> 02:19:23,378
REPORTS STARTS WITH ADULTS ON 

3402
02:19:23,378 --> 02:19:26,481
THE LEFT WHO ARE OVERWEIGHT OR 

3403
02:19:26,481 --> 02:19:26,815
HAVE OBESITY.

3404
02:19:26,815 --> 02:19:29,784
IF THAT INVOLVES A PRIMARY CARE 

3405
02:19:29,784 --> 02:19:30,852
ASSESSMENT FOR CANDIDATES FOR 

3406
02:19:30,852 --> 02:19:33,188
WEIGHT LOSS OR WEIGHT LOSS 

3407
02:19:33,188 --> 02:19:34,989
MAINTENANCE INTERVENTIONS.

3408
02:19:34,989 --> 02:19:36,658
AND THAT'S BASICALLY THOSE WHO 

3409
02:19:36,658 --> 02:19:38,126
ARE OBESE OR OVERWEIGHT.

3410
02:19:38,126 --> 02:19:39,694
WHAT YOU SEE THEN IS AN 

3411
02:19:39,694 --> 02:19:42,697
INTERVENTION.

3412
02:19:42,697 --> 02:19:44,732
BEHAVIORAL OR PHARMACOTHERAPY 

3413
02:19:44,732 --> 02:19:45,066
INTERVENTIONS.

3414
02:19:45,066 --> 02:19:47,702
AND YOU CAN SEE THE NUMBER ONE 

3415
02:19:47,702 --> 02:19:50,505
GOES DIRECTLY TO THE RIGHT TO 

3416
02:19:50,505 --> 02:19:52,073
HEALTH OUTCOMES.

3417
02:19:52,073 --> 02:19:54,776
IN AN RCT DO THOSE 

3418
02:19:54,776 --> 02:19:55,577
INTERVENTIONS AFFECT AND 

3419
02:19:55,577 --> 02:19:58,947
MEASURE MORBIDITY, MORTALITY OR 

3420
02:19:58,947 --> 02:20:03,718
QUALITY OF LIFE FOR FUNCTIONING.

3421
02:20:03,718 --> 02:20:06,554
THAT'S OUR DIRECT EVIDENCE LINK.

3422
02:20:06,554 --> 02:20:09,190
INDIRECT GOES THROUGH #2, 

3423
02:20:09,190 --> 02:20:10,158
RANDOMIZED TRIALS MIGHT 

3424
02:20:10,158 --> 02:20:11,626
DEMONSTRATE WEIGHT LOSS OR 

3425
02:20:11,626 --> 02:20:15,597
WEIGHT LOSS MAINTENANCE OR 

3426
02:20:15,597 --> 02:20:18,500
EFFECT ON INCIDENCE OR 

3427
02:20:18,500 --> 02:20:19,200
PREVALENCE OF OBESITY-RELATED 

3428
02:20:19,200 --> 02:20:19,701
CONDITIONS.

3429
02:20:19,701 --> 02:20:22,103
YOU SEE A DASHED LINE.

3430
02:20:22,103 --> 02:20:25,707
THE QUESTION, DOES THAT LEAD 

3431
02:20:25,707 --> 02:20:27,842
THAT INDIRECT EVIDENCE CHAIN 

3432
02:20:27,842 --> 02:20:29,444
LEAD TO IMPROVEMENT IN HEALTH 

3433
02:20:29,444 --> 02:20:30,111
OUTCOMES.

3434
02:20:30,111 --> 02:20:31,746
AND FOR ALL OUR RECOMMENDATION 

3435
02:20:31,746 --> 02:20:33,414
STATEMENTS YOU COULD LOOK AT 

3436
02:20:33,414 --> 02:20:35,917
#3, WE ARE ALWAYS LOOKING AT 

3437
02:20:35,917 --> 02:20:37,318
THE ADVERSE EFFECTS OF THE 

3438
02:20:37,318 --> 02:20:39,854
INTERVENTIONS.

3439
02:20:39,854 --> 02:20:41,489
SO IN 2018, LOOKING AT THE 

3440
02:20:41,489 --> 02:20:43,591
EVIDENCE AS WE DO, WHAT DID 

3441
02:20:43,591 --> 02:20:47,795
THAT FIND FOR FARM CO THERAPY?

3442
02:20:47,795 --> 02:20:50,431
WE FOUND 32 RANDOMIZED CONTROL 

3443
02:20:50,431 --> 02:20:52,734
TRIALS FOR WEIGHT LOSS OR 

3444
02:20:52,734 --> 02:20:54,802
WEIGHT LOSS MANAGEMENT.

3445
02:20:54,802 --> 02:21:05,246
WE FOUND FOR LIRAGLUTIDE, 

3446
02:21:08,416 --> 02:21:13,154
LORCASERIN, NALTREXONE, 

3447
02:21:13,154 --> 02:21:17,692
BUPROPION, ORLISTAT AND 

3448
02:21:17,692 --> 02:21:19,193
PHENTERMINE-TOPIRAMATE ALL WITH 

3449
02:21:19,193 --> 02:21:21,863
BEHAVE YOAL COUNSELING.

3450
02:21:21,863 --> 02:21:24,599
WE FOUND IN 14 STUDIES 

3451
02:21:24,599 --> 02:21:26,067
INVOLVING OVER 22,000 PATIENTS.

3452
02:21:26,067 --> 02:21:27,302
BUT HERE IS THE RIB.

3453
02:21:27,302 --> 02:21:31,673
WHEN WE LOOKED AT INCLUSION 

3454
02:21:31,673 --> 02:21:37,679
CRITERIA REQUIRED DEMONSTRATION 

3455
02:21:37,679 --> 02:21:38,913
OF MEDICATION ADHERENCE, 

3456
02:21:38,913 --> 02:21:42,050
REQUIRED MEETING WEIGHT LOSS 

3457
02:21:42,050 --> 02:21:46,421
GOALS OR BOTH BEFORE 

3458
02:21:46,421 --> 02:21:49,123
ENROLLMENT, NARROW ELIGIBILITY 

3459
02:21:49,123 --> 02:21:50,925
OF THOSE, THERE BY LIMITING 

3460
02:21:50,925 --> 02:21:52,026
APPLICABILITY.

3461
02:21:52,026 --> 02:21:56,464
MORE OVER TRIAL COMPLETION 

3462
02:21:56,464 --> 02:22:00,802
RANGED FROM 10-93%, MOST 50-70%.

3463
02:22:00,802 --> 02:22:05,273
THERE WERE FEW RCT'S PER DRUG 

3464
02:22:05,273 --> 02:22:06,674
AND VARIABILITY IN THE OUTCOME 

3465
02:22:06,674 --> 02:22:07,942
REPORTING.

3466
02:22:07,942 --> 02:22:10,244
WE ALSO LOOKED AT QUALITY OF 

3467
02:22:10,244 --> 02:22:10,445
LIFE.

3468
02:22:10,445 --> 02:22:13,348
AGAIN, WE FOUND EVIDENCE THESE 

3469
02:22:13,348 --> 02:22:14,849
MEDICATIONS WITH BEHAVIORAL 

3470
02:22:14,849 --> 02:22:15,516
COUNSELING IMPROVED QUALITY OF 

3471
02:22:15,516 --> 02:22:19,654
LIFE.

3472
02:22:19,654 --> 02:22:21,522
THE EFFECTS WERE SMALL AND 

3473
02:22:21,522 --> 02:22:23,391
CLINICAL SIGNIFICANCE OF THOSE 

3474
02:22:23,391 --> 02:22:24,926
EFFECTS WERE UNCERTAIN.

3475
02:22:24,926 --> 02:22:27,128
MORE OVER THERE WAS A DROP OUT 

3476
02:22:27,128 --> 02:22:29,597
RATE THAT WAS 35% OR HIGHER IN 

3477
02:22:29,597 --> 02:22:32,100
5 OF THE 10 STUDIES.

3478
02:22:32,100 --> 02:22:34,002
WE ALSO LOOKED AT WHETHER OR 

3479
02:22:34,002 --> 02:22:35,169
NOT IT DECREASED INCIDENT 

3480
02:22:35,169 --> 02:22:36,070
DIABETES.

3481
02:22:36,070 --> 02:22:38,506
THAT WAS FOR TRIALS WITH NEARLY 

3482
02:22:38,506 --> 02:22:39,440
10,000 PATIENTS.

3483
02:22:39,440 --> 02:22:41,009
BUT AGAIN, WE SAW THAT HIGH 

3484
02:22:41,009 --> 02:22:42,243
DROP OUT RATE.

3485
02:22:42,243 --> 02:22:44,445
WITH REGARD TO WEIGHT LOSS 

3486
02:22:44,445 --> 02:22:45,713
MAINTENANCE THERE WERE THREE 

3487
02:22:45,713 --> 02:22:47,982
STUDIES WITH A LITTLE OVER 

3488
02:22:47,982 --> 02:22:50,151
1,000 PATIENTS, NONE OF THEM 

3489
02:22:50,151 --> 02:22:51,786
REPORTED HEALTH OUTCOMES.

3490
02:22:51,786 --> 02:22:53,655
SO IN CONTRAST TO THAT TITLE 

3491
02:22:53,655 --> 02:22:55,790
FROM OUR EVIDENCE REVIEW TEAM, 

3492
02:22:55,790 --> 02:22:58,226
YOU SEE OUR FINAL 

3493
02:22:58,226 --> 02:22:59,894
RECOMMENDATION STATEMENT 

3494
02:22:59,894 --> 02:23:01,529
DOESN'T EVEN MENTION 

3495
02:23:01,529 --> 02:23:03,831
PHARMACOTHERAPY, AND WHY NOT?

3496
02:23:03,831 --> 02:23:05,933
WE WERE UNCLEAR ABOUT HOW WELL 

3497
02:23:05,933 --> 02:23:07,101
PATIENTS TOLERATE THESE 

3498
02:23:07,101 --> 02:23:08,302
MEDICATIONS AND WHETHER THE 

3499
02:23:08,302 --> 02:23:11,339
FINDINGS ARE APPLICABLE TO THE 

3500
02:23:11,339 --> 02:23:13,808
GENERAL U.S. PRIMARY CARE 

3501
02:23:13,808 --> 02:23:14,108
POPULATION.

3502
02:23:14,108 --> 02:23:16,077
MORE OVER WE FOUND DATA WERE 

3503
02:23:16,077 --> 02:23:18,780
LACKING ABOUT THE MAINTS NANS 

3504
02:23:18,780 --> 02:23:20,682
OF IMPROVEMENT AFTER 

3505
02:23:20,682 --> 02:23:21,115
DISCONTINUATION OF 

3506
02:23:21,115 --> 02:23:21,949
PHARMACOTHERAPY.

3507
02:23:21,949 --> 02:23:26,287
AS A RESULT, THE USPSTF 

3508
02:23:26,287 --> 02:23:28,556
ENCOURAGES CLINICIANS TO 

3509
02:23:28,556 --> 02:23:28,990
PROMOTE BEHAVIORAL 

3510
02:23:28,990 --> 02:23:30,625
INTERVENTIONS AS THE PRIMARY 

3511
02:23:30,625 --> 02:23:31,893
FOCUS OF EFFECTIVE 

3512
02:23:31,893 --> 02:23:32,860
INTERVENTIONS FOR WEIGHT LOSS 

3513
02:23:32,860 --> 02:23:33,594
IN ADULTS.

3514
02:23:33,594 --> 02:23:36,297
THAT WAS OUR B RECOMMENDATION 

3515
02:23:36,297 --> 02:23:36,864
IN 2018.

3516
02:23:36,864 --> 02:23:38,733
HOW WE THINK OF THE EVIDENCE 

3517
02:23:38,733 --> 02:23:40,635
AND OUTCOMES AND THE PATIENT 

3518
02:23:40,635 --> 02:23:42,036
POPULATION FOR WHICH WE MAKE 

3519
02:23:42,036 --> 02:23:43,805
OUR RECOMMENDATIONS.

3520
02:23:43,805 --> 02:23:46,674
WHILE COMPARE AND CONTRAST OUR 

3521
02:23:46,674 --> 02:23:50,378
2018 TO THE MOST RECENT 

3522
02:23:50,378 --> 02:23:52,080
AMERICAN DIABETES ASSOCIATION 

3523
02:23:52,080 --> 02:23:53,748
ANNUAL STANDARDS OF CARE IN 

3524
02:23:53,748 --> 02:23:54,015
DIABETES.

3525
02:23:54,015 --> 02:23:56,050
SO THIS IS WHAT THEY DO 

3526
02:23:56,050 --> 02:23:57,552
ANNUALLY IN JANUARY, BASED ON 

3527
02:23:57,552 --> 02:24:03,024
THE EVIDENCE THEY GARNER.

3528
02:24:03,024 --> 02:24:04,459
THE ADA'S EVIDENCE-GRADING 

3529
02:24:04,459 --> 02:24:06,294
SYSTEM, AS ARTICULATED IN THEIR 

3530
02:24:06,294 --> 02:24:08,329
METHODS RANGES FROM LEVEL A, B, 

3531
02:24:08,329 --> 02:24:13,000
C AND E, WHERE A IS CLEAR OR 

3532
02:24:13,000 --> 02:24:13,568
SUPPORTIVE WELL-CONDUCTED 

3533
02:24:13,568 --> 02:24:16,971
ADEQUATELY POW HE HAD RCTS.

3534
02:24:16,971 --> 02:24:19,440
LEVEL B IS SUPPORTIVE WELL 

3535
02:24:19,440 --> 02:24:21,008
CONDUCTED COHORT OR CASE 

3536
02:24:21,008 --> 02:24:21,976
CONTROL STUDIES.

3537
02:24:21,976 --> 02:24:24,245
C IS POORLY CONTROLLED OR 

3538
02:24:24,245 --> 02:24:26,147
UNCONTROLLED AND E IS EXPERT 

3539
02:24:26,147 --> 02:24:26,380
OPINION.

3540
02:24:26,380 --> 02:24:28,416
I WANT TO HIGHLIGHT THAT ALL 

3541
02:24:28,416 --> 02:24:30,084
RECOMMENDATIONS FOR THEM 

3542
02:24:30,084 --> 02:24:31,285
RECEIVE A RATING FOR THE 

3543
02:24:31,285 --> 02:24:32,754
STRENGTH OF THE EVIDENCE AND 

3544
02:24:32,754 --> 02:24:34,789
NOT THE STRENGTH OF THE 

3545
02:24:34,789 --> 02:24:35,256
RECOMMENDATION.

3546
02:24:35,256 --> 02:24:37,158
YOU CAN THINK OF THE STRENGTH 

3547
02:24:37,158 --> 02:24:38,226
OF RECOMMENDATION PERHAPS AS 

3548
02:24:38,226 --> 02:24:40,628
THE MAGNITUDE OF NET BENEFIT.

3549
02:24:40,628 --> 02:24:42,330
SO WHAT DID THEY FIND WHEN THEY 

3550
02:24:42,330 --> 02:24:44,432
DID THE EVIDENCE REVIEW?

3551
02:24:44,432 --> 02:24:47,735
PRETTY MUCH SIMILAR TO WHAT WE 

3552
02:24:47,735 --> 02:24:51,539
FOUND FOR MEDICATIONS.

3553
02:24:51,539 --> 02:24:54,675
A WEIGHT LOSS PERCENTAGE THAT 

3554
02:24:54,675 --> 02:25:03,151
RANGES FROM ROUGHLY 5% TO 10% 

3555
02:25:03,151 --> 02:25:08,923
FOR PRE-GLP-1 RECEPTOR AGONIST.

3556
02:25:08,923 --> 02:25:14,729
GLP-1

3557
02:25:14,729 --> 02:25:19,734
DUAL THEY FOUND OVER 10%, 

3558
02:25:19,734 --> 02:25:20,735
ROUGHLY 13% REDUCTION IN WEIGHT 

3559
02:25:20,735 --> 02:25:21,602
LOSS.

3560
02:25:21,602 --> 02:25:23,504
SO HOW DID THIS TRANSLATE WHEN 

3561
02:25:23,504 --> 02:25:25,039
THEY MADE THEIR OBESITY 

3562
02:25:25,039 --> 02:25:26,240
RECOMMENDATIONS?

3563
02:25:26,240 --> 02:25:27,809
AGAIN, I'M FOCUSING ON OBESITY 

3564
02:25:27,809 --> 02:25:30,011
BECAUSE IT WOULD BE MOST 

3565
02:25:30,011 --> 02:25:32,580
COMPARABLE TO OUR 2018 

3566
02:25:32,580 --> 02:25:34,949
RECOMMENDATION.

3567
02:25:34,949 --> 02:25:39,053
SO IN 8.5, CHAPTER ON OBESITY 

3568
02:25:39,053 --> 02:25:48,296
SAID WEIGHT LOSS  OF 3-7% OF 

3569
02:25:48,296 --> 02:25:50,431
BASELINE WEIGHT IMPROVES GUY 

3570
02:25:50,431 --> 02:25:52,967
SEMIA AND OTHER IMMEDIATE 

3571
02:25:52,967 --> 02:25:53,801
CARDIOVASCULAR RISK FACTORS, 

3572
02:25:53,801 --> 02:25:56,571
THEY GAVE THAT AN A.

3573
02:25:56,571 --> 02:25:58,906
SUSTAINED LOSS OF MORE THAN 10% 

3574
02:25:58,906 --> 02:26:01,843
OF BODY WEIGHT USUALLY CONFERS 

3575
02:26:01,843 --> 02:26:03,711
GREATER BENEFITS, INCLUDING 

3576
02:26:03,711 --> 02:26:05,012
DISEASE MODIFYING EFFECTS AND 

3577
02:26:05,012 --> 02:26:06,447
POSSIBLE REMEIGS OF TYPE II 

3578
02:26:06,447 --> 02:26:09,450
DIABETES AND MAY IMPROVE LONG 

3579
02:26:09,450 --> 02:26:10,084
TERM CARDIOVASCULAR OUTCOMES 

3580
02:26:10,084 --> 02:26:11,085
AND MORTALITY.

3581
02:26:11,085 --> 02:26:13,221
THEY WENT ONTO CONCLUDE 

3582
02:26:13,221 --> 02:26:18,826
PREFERRED FARM CO THERAPY 

3583
02:26:18,826 --> 02:26:20,294
SHOULD BE GLP-1 IN PARTICULAR 

3584
02:26:20,294 --> 02:26:22,597
BECAUSE OF WEIGHT INDEPENDENT 

3585
02:26:22,597 --> 02:26:28,035
BENEFITS SUCH AS GLYCEMIC AND 

3586
02:26:28,035 --> 02:26:29,737
CARDIO METABOLIC BENEFITS.

3587
02:26:29,737 --> 02:26:31,539
SO TO COMPARE AND CONTRAST WHAT 

3588
02:26:31,539 --> 02:26:35,109
I HOPE YOU TAKE AWAY FROM THAT, 

3589
02:26:35,109 --> 02:26:38,212
THE USPSTF THINKS ABOUT HIGH OR 

3590
02:26:38,212 --> 02:26:39,046
MODERATE CERTAINTY, RCT 

3591
02:26:39,046 --> 02:26:41,282
EVIDENCE THAT IS EITHER 

3592
02:26:41,282 --> 02:26:43,150
SUBSTANTIAL OR MODERATE IN NET 

3593
02:26:43,150 --> 02:26:45,286
BENEFIT ON HEALTH OUTCOMES FOR 

3594
02:26:45,286 --> 02:26:48,122
THEIR A OR B RECOMMENDATIONS.

3595
02:26:48,122 --> 02:26:51,492
THOSE HEALTH OUTCOMES INVOLVE 

3596
02:26:51,492 --> 02:26:52,493
SYMPTOMS, FUNCTIONAL LEVELS 

3597
02:26:52,493 --> 02:26:54,462
THAT PATIENTS CAN FEEL OR 

3598
02:26:54,462 --> 02:26:54,762
EXPERIENCE.

3599
02:26:54,762 --> 02:26:57,131
AND WHEN WE THINK ABOUT 

3600
02:26:57,131 --> 02:27:01,135
REAL-WORLD EVIDENCE FOR HARMS, 

3601
02:27:01,135 --> 02:27:01,636
BENEFITS, EPIDEMIOLOGY 

3602
02:27:01,636 --> 02:27:03,237
MODELING, WE DO INCORPORATE OR 

3603
02:27:03,237 --> 02:27:08,442
THINK ABOUT THEM IN OUR 

3604
02:27:08,442 --> 02:27:08,809
CONSIDERATIONS.

3605
02:27:08,809 --> 02:27:11,612
IN PARTICULAR, WE VALUE 

3606
02:27:11,612 --> 02:27:13,447
PRAGMATIC STUDIES, WHICH HELP 

3607
02:27:13,447 --> 02:27:16,250
US THINK ABOUT FEASIBILITY AND 

3608
02:27:16,250 --> 02:27:18,052
APPLICABILITY.

3609
02:27:18,052 --> 02:27:20,988
AND THUS IMPROVING ON EXTERNAL 

3610
02:27:20,988 --> 02:27:22,223
VALIDITY AS COMPARED TO 

3611
02:27:22,223 --> 02:27:25,960
INTERNAL VALIDITY OF RCT'S.

3612
02:27:25,960 --> 02:27:28,296
TO THEN LOOK AT THE ADA AND 

3613
02:27:28,296 --> 02:27:30,831
THEIR STANDARDS OF CARE THAT'S 

3614
02:27:30,831 --> 02:27:32,700
UPDATED ANNUALLY, THEY 

3615
02:27:32,700 --> 02:27:43,244
INCORPORATE RCT DATE   --  WELL 

3616
02:27:45,513 --> 02:27:47,148
CONDUCTED COHORT OR CASE 

3617
02:27:47,148 --> 02:27:50,685
CONTROL STUDIES FOR A OR B 

3618
02:27:50,685 --> 02:27:52,620
LEVELS.

3619
02:27:52,620 --> 02:27:56,123
OUTCOMES, 3-7% WEIGHT LOSS ON 

3620
02:27:56,123 --> 02:27:57,425
GLYCEMIA AND CARDIOVASCULAR 

3621
02:27:57,425 --> 02:27:59,493
RISK AND POSSIBLE WEIGHT 

3622
02:27:59,493 --> 02:28:03,230
INDEPENDENT BENEFITS OF 

3623
02:28:03,230 --> 02:28:04,231
GLP-1-1R OR GLP-1.

3624
02:28:04,231 --> 02:28:08,169
I WANT TO CONCLUDE WITH 

3625
02:28:08,169 --> 02:28:10,604
RESEARCH GAPS AND NEEDS.

3626
02:28:10,604 --> 02:28:11,872
THE TASK FORCE RECOMMENDS 

3627
02:28:11,872 --> 02:28:14,842
FURTHER RESEARCH TO EXAMINE 

3628
02:28:14,842 --> 02:28:16,744
EFFECTS OF INTERVENTIONS FOR 

3629
02:28:16,744 --> 02:28:18,813
OBESITY ON LONGER TERM WEIGHT 

3630
02:28:18,813 --> 02:28:21,082
AND HEALTH OUTCOMES, SUCH AS 

3631
02:28:21,082 --> 02:28:22,116
CARDIOVASCULAR OUTCOMES, 

3632
02:28:22,116 --> 02:28:24,418
PSYCHOSOCIAL, QUALITY OF LIFE 

3633
02:28:24,418 --> 02:28:25,453
AND PATIENT-CENTERED OUTCOMES.

3634
02:28:25,453 --> 02:28:27,321
FOR THE 2025 ADA, SUSTAINED 

3635
02:28:27,321 --> 02:28:30,858
LOSS OF MORE THAN 10% PROVIDES 

3636
02:28:30,858 --> 02:28:32,526
POSSIBLE REMISSION OF TYPE II 

3637
02:28:32,526 --> 02:28:35,429
DIABETES AND MAY IMPROVE 

3638
02:28:35,429 --> 02:28:36,297
LONG-TERM CARDIOVASCULAR 

3639
02:28:36,297 --> 02:28:37,498
OUTCOMES AND MORTALITY.

3640
02:28:37,498 --> 02:28:39,200
THEY HIGHLIGHT THE GROWING GAPS 

3641
02:28:39,200 --> 02:28:41,502
IN DIABETES CARE, QUALITY AND 

3642
02:28:41,502 --> 02:28:44,405
OUTCOMES AND CALL FOR URGENT, 

3643
02:28:44,405 --> 02:28:47,074
SUBSTANTIAL AND MULTI-SECTORIAL 

3644
02:28:47,074 --> 02:28:49,777
SYSTEM LEVEL IMPROVEMENT TO 

3645
02:28:49,777 --> 02:28:50,077
HEALTH CARE.

3646
02:28:50,077 --> 02:28:52,713
AND WITH THAT, I'M GOING TO 

3647
02:28:52,713 --> 02:28:54,348
STOP SHARING AND TURN THE 

3648
02:28:54,348 --> 02:29:02,523
SCREEN OVER TO MY COLLEAGUE.

3649
02:29:02,523 --> 02:29:04,558
>> CHRISTINE WEE: THANK
YOU, 

3650
02:29:04,558 --> 02:29:05,693
DR. WONG.

3651
02:29:05,693 --> 02:29:07,795
NEXT WE WILL HAVE DR. SKINNER 

3652
02:29:07,795 --> 02:29:10,131
WHO WILL SHARE HER PERSPECTIVE 

3653
02:29:10,131 --> 02:29:20,608
IN GUIDELINES FOR PEDIATRIC 

3654
02:29:22,843 --> 02:29:25,679
OBESITY.

3655
02:29:25,679 --> 02:29:27,148
>> DR. SKINNER: THANK YOU,

3656
02:29:27,148 --> 02:29:27,948
EVERYBODY FOR THE OPPORTUNITY 

3657
02:29:27,948 --> 02:29:29,050
TO PRESENT HERE.

3658
02:29:29,050 --> 02:29:31,485
I WILL FOLLOW JOHN WITH LOOKING 

3659
02:29:31,485 --> 02:29:33,988
AT SOME OF THE REAL-WORLD 

3660
02:29:33,988 --> 02:29:35,689
EVIDENCE AND THE PRACTICE 

3661
02:29:35,689 --> 02:29:38,859
GUIDELINES WE HAVE FOR CHILDREN 

3662
02:29:38,859 --> 02:29:40,828
RELATED TO PHARMACOTHERAPIES, 

3663
02:29:40,828 --> 02:29:48,969
SPECIFICALLY GLP-1'S.

3664
02:29:48,969 --> 02:29:51,038
I WILL START WITH I HAVE NO 

3665
02:29:51,038 --> 02:29:53,441
CONFLICTS OF INTEREST OR 

3666
02:29:53,441 --> 02:29:54,175
FINANCIAL RELATIONSHIPS.

3667
02:29:54,175 --> 02:30:04,552
I DID SERVE AS LEAD  

3668
02:30:07,822 --> 02:30:11,092
METHODOLOGIST.

3669
02:30:11,092 --> 02:30:16,030
IN JANUARY 2023, AMERICAN 

3670
02:30:16,030 --> 02:30:17,865
ACADEMY OF PEDIATRICS PUBLISHED 

3671
02:30:17,865 --> 02:30:19,767
FIRST EVER CLINICAL PRACTICE 

3672
02:30:19,767 --> 02:30:20,601
GUIDELINE FOR EVALUATION AND 

3673
02:30:20,601 --> 02:30:22,703
TREATMENT OF CHILDREN AND 

3674
02:30:22,703 --> 02:30:24,605
ADOLESCENTS WITH OBESITY.

3675
02:30:24,605 --> 02:30:28,876
PRIOR TO THIS THERE WAS ONLY 

3676
02:30:28,876 --> 02:30:31,145
EXPERT OPINIONS, NO GUIDELINES.

3677
02:30:31,145 --> 02:30:35,149
JOHN DESCRIBED HOW THE USPSTF 

3678
02:30:35,149 --> 02:30:38,452
GRADES THEM AND ADA.

3679
02:30:38,452 --> 02:30:40,154
AAP USES SIMILAR GRADING SYSTEM 

3680
02:30:40,154 --> 02:30:43,357
AS FAR AS GRADING, WITH A, B, 

3681
02:30:43,357 --> 02:30:44,058
C, ET CETERA.

3682
02:30:44,058 --> 02:30:46,460
I WILL PRESENT THE FINAL 

3683
02:30:46,460 --> 02:30:48,195
TREATMENT ALGORITHM THAT WAS 

3684
02:30:48,195 --> 02:30:51,132
ULTIMATELY DEVELOPED.

3685
02:30:51,132 --> 02:30:55,569
AND IT RECOMMENDS MOTIVATIONAL 

3686
02:30:55,569 --> 02:30:57,204
INTERVIEWING AND INTENSIVE 

3687
02:30:57,204 --> 02:31:00,107
HEALTH BEHAVIOR AND LIFESTYLE 

3688
02:31:00,107 --> 02:31:02,810
TREATMENT FOR CHILDREN WITH 

3689
02:31:02,810 --> 02:31:03,277
OBESITY.

3690
02:31:03,277 --> 02:31:06,614
DEFINITELY FOR AGES 6 AND OLDER.

3691
02:31:06,614 --> 02:31:09,683
THIS IS NOT UNEXPECTED AT ALL.

3692
02:31:09,683 --> 02:31:10,918
HOWEVER, WE ALSO RECOMMENDED 

3693
02:31:10,918 --> 02:31:14,054
FOR CHILDREN WITH OBESITY AT 

3694
02:31:14,054 --> 02:31:16,323
THE AGE OF 12 OR OVER TO 

3695
02:31:16,323 --> 02:31:17,825
CONSIDER WEIGHT LOSS 

3696
02:31:17,825 --> 02:31:18,859
PHARMACOTHERAPY AND THAT SHOULD 

3697
02:31:18,859 --> 02:31:20,327
BE OFFERED TO THOSE CHILDREN.

3698
02:31:20,327 --> 02:31:26,133
AS WELL AS BARIATRIC SURGERY.

3699
02:31:26,133 --> 02:31:29,670
SO GLP-1'S HAVE A PARTICULARLY 

3700
02:31:29,670 --> 02:31:32,773
UNIQUE PLACE IN PEDIATRICS, AND 

3701
02:31:32,773 --> 02:31:34,608
THAT'S BECAUSE CHILDREN REALLY 

3702
02:31:34,608 --> 02:31:39,146
DON'T LIKE NEEDLES AT ALL.

3703
02:31:39,146 --> 02:31:44,285
WE HAVE EVIDENCE OF 

3704
02:31:44,285 --> 02:31:46,153
PHENTERMINE, SOMEWHAT EFFECTIVE.

3705
02:31:46,153 --> 02:31:50,591
AND WE ALSO KNOW SEMAGLUTIDE IS 

3706
02:31:50,591 --> 02:31:53,460
MORE EFFECT ITCH.

3707
02:31:53,460 --> 02:31:54,261
EFFECTIVE.

3708
02:31:54,261 --> 02:31:55,963
WHEN FAMILIES ARE MAKING THE 

3709
02:31:55,963 --> 02:31:57,965
DECISION, IT'S WHETHER OR NOT A 

3710
02:31:57,965 --> 02:32:00,067
CHILD IS INTERESTED IN 

3711
02:32:00,067 --> 02:32:01,936
INTERESTING AN INJECTION.

3712
02:32:01,936 --> 02:32:07,541
IT'S LESS PROBLEMATIC WITH 

3713
02:32:07,541 --> 02:32:12,947
SEMAGLUTIDE BECAUSE ITS WEEKLY.

3714
02:32:12,947 --> 02:32:14,315
ONE THING THAT'S REALLY 

3715
02:32:14,315 --> 02:32:15,883
IMPORTANT IS WE ARE STILL 

3716
02:32:15,883 --> 02:32:17,151
BUILDING THE PLANE WHILE WE ARE 

3717
02:32:17,151 --> 02:32:18,419
FLYING IT.

3718
02:32:18,419 --> 02:32:21,088
WE HAVE RELATIVELY LITTLE 

3719
02:32:21,088 --> 02:32:23,023
EVIDENCE BEYOND THE TRIALS THAT 

3720
02:32:23,023 --> 02:32:24,158
WERE USED.

3721
02:32:24,158 --> 02:32:28,362
WE HAVE ONE STRONG SEMAGLUTIDE 

3722
02:32:28,362 --> 02:32:30,030
TRIAL, THE TIRZEPATIDE TRIAL IS 

3723
02:32:30,030 --> 02:32:31,065
STILL UNDER WAY.

3724
02:32:31,065 --> 02:32:33,200
WE DON'T EVEN HAVE FDA APPROVAL 

3725
02:32:33,200 --> 02:32:35,936
FOR THAT IN ADOLESCENCE.

3726
02:32:35,936 --> 02:32:37,371
PHYSICIANS ARE REALLY JUST 

3727
02:32:37,371 --> 02:32:39,039
TRYING TO MAKE A LOT OF 

3728
02:32:39,039 --> 02:32:41,542
DECISIONS AS THEY GO, BASED ON 

3729
02:32:41,542 --> 02:32:45,112
THEIR CURRENT CLINICAL JUDGMENT.

3730
02:32:45,112 --> 02:32:48,349
THERE'S A COUPLE UNIQUE FACTORS.

3731
02:32:48,349 --> 02:32:50,484
IT'S TRUE FOR ADULTS.

3732
02:32:50,484 --> 02:32:51,986
BUT PARTICULARLY WITH CHILDREN 

3733
02:32:51,986 --> 02:32:54,121
BECAUSE THE LEVEL OF MEDICAID 

3734
02:32:54,121 --> 02:32:57,258
COVERAGE IS SO HIGH.

3735
02:32:57,258 --> 02:32:59,526
THE MAP HERE IS DEMONSTRATING 

3736
02:32:59,526 --> 02:33:03,264
THE LEVEL OF MID EDICAID 

3737
02:33:03,264 --> 02:33:11,572
COVERAGE FOR GLP-1'S.

3738
02:33:11,572 --> 02:33:14,508
EITHER LIRAGLATIDE OR 

3739
02:33:14,508 --> 02:33:14,808
SEMAGLUTIDE.

3740
02:33:14,808 --> 02:33:17,378
MOST HAVE NO COVERAGE OR ARE 

3741
02:33:17,378 --> 02:33:19,013
COVERED WITH RESTRICTIONS.

3742
02:33:19,013 --> 02:33:20,748
SOME HAVE OTHER LIMITATIONS.

3743
02:33:20,748 --> 02:33:23,017
I DON'T THINK THERE'S A SINGLE 

3744
02:33:23,017 --> 02:33:25,586
STATE WHERE IT'S ACTUALLY JUST 

3745
02:33:25,586 --> 02:33:26,820
OPENLY COVERED.

3746
02:33:26,820 --> 02:33:28,222
BUT WHAT'S ALSO REALLY 

3747
02:33:28,222 --> 02:33:31,392
IMPORTANT IS THIS CHANGES ALL 

3748
02:33:31,392 --> 02:33:33,027
THIS MONTH-TO-MONTH.

3749
02:33:33,027 --> 02:33:35,129
FOR EXAMPLE, NORTH CAROLINA NOW 

3750
02:33:35,129 --> 02:33:39,633
DOES COVER THEM WITH FEWER 

3751
02:33:39,633 --> 02:33:41,335
LIMITATIONS BUT MINNESOTA HAS 

3752
02:33:41,335 --> 02:33:42,403
NOW STOPPED COVERING.

3753
02:33:42,403 --> 02:33:43,804
AND IT'S POSSIBLE THAT'S 

3754
02:33:43,804 --> 02:33:44,838
CHANGED SINCE THE LAST TIME I 

3755
02:33:44,838 --> 02:33:45,839
READ THAT.

3756
02:33:45,839 --> 02:33:48,108
SO WHAT WE HAVE, AND WHAT THAT 

3757
02:33:48,108 --> 02:33:49,777
RESULTS IN, WE HAVE A 

3758
02:33:49,777 --> 02:33:51,111
POPULATION OF CHILDREN WHO ARE 

3759
02:33:51,111 --> 02:33:53,647
OFTEN GOING ON AND OFF THESE 

3760
02:33:53,647 --> 02:33:53,947
MEDICATIONS.

3761
02:33:53,947 --> 02:33:55,182
THIS IS A REAL OPPORTUNITY TO 

3762
02:33:55,182 --> 02:33:57,084
USE SOME OF THESE REAL-WORLD 

3763
02:33:57,084 --> 02:33:58,952
EVIDENCE TO SEE WHAT HAPPENS, 

3764
02:33:58,952 --> 02:34:01,255
IF A CHILD HAS HAD A LOT OF 

3765
02:34:01,255 --> 02:34:03,590
SUCCESS, WHAT HAPPENS WHEN THEY 

3766
02:34:03,590 --> 02:34:05,125
THEN DISCONTINUE.

3767
02:34:05,125 --> 02:34:06,627
THAT'S ACTUALLY ONE OF THE 

3768
02:34:06,627 --> 02:34:10,597
BIGGEST QUESTIONS THAT WE HAVE.

3769
02:34:10,597 --> 02:34:13,233
WHAT DO WE NEED TO KNOW?

3770
02:34:13,233 --> 02:34:15,035
WE HAVE VERY LITTLE EVIDENCE ON 

3771
02:34:15,035 --> 02:34:16,470
WHAT THE BEST CLINICAL 

3772
02:34:16,470 --> 02:34:18,505
MANAGEMENT IS IN CHILDREN.

3773
02:34:18,505 --> 02:34:21,241
SIMILAR TO WHAT JOHN MENTIONED 

3774
02:34:21,241 --> 02:34:23,077
THERE ARE A LOT OF LIMITATIONS 

3775
02:34:23,077 --> 02:34:24,211
ON THE POPULATIONS INCLUDED IN 

3776
02:34:24,211 --> 02:34:25,112
THE TRIALS.

3777
02:34:25,112 --> 02:34:27,781
AND WE HAVE EVEN FEWER TRIALS 

3778
02:34:27,781 --> 02:34:30,517
THAN EXIST FOR ADULTS.

3779
02:34:30,517 --> 02:34:32,586
MEANING THERE'S FEWER CO 

3780
02:34:32,586 --> 02:34:33,620
MORBIDITIES, ET CETERA.

3781
02:34:33,620 --> 02:34:35,089
IT'S NOT CLEAR HOW THIS 

3782
02:34:35,089 --> 02:34:36,123
TRANSLATES INTO THE GENERAL 

3783
02:34:36,123 --> 02:34:42,296
POPULATION.

3784
02:34:42,296 --> 02:34:44,798
ONE OF THE MORE DIFFICULT 

3785
02:34:44,798 --> 02:34:47,067
THINGS AND OFTEN IMPORTANT FOR 

3786
02:34:47,067 --> 02:34:48,969
KIDS BECAUSE IT'S DIFFICULT FOR 

3787
02:34:48,969 --> 02:34:50,003
FAMILIES TO CONSIDER TAKING 

3788
02:34:50,003 --> 02:34:51,939
THEIR CHILDREN AND PUTTING THEM 

3789
02:34:51,939 --> 02:34:53,741
ON A LIFE-LONG MEDICATION.

3790
02:34:53,741 --> 02:34:56,844
AND SO THE QUESTION IS, WHEN DO 

3791
02:34:56,844 --> 02:34:57,211
YOU DISCONTINUE?

3792
02:34:57,211 --> 02:34:59,947
HOW DO YOU DISCONTINUE?

3793
02:34:59,947 --> 02:35:06,120
WHAT IS THE RISK OF REGAIN?

3794
02:35:06,120 --> 02:35:07,855
HOW DO WE LIMIT THAT.

3795
02:35:07,855 --> 02:35:08,889
THERE ARE QUESTIONS WHO WE 

3796
02:35:08,889 --> 02:35:10,758
SHOULD BE ABLE TO TREAT.

3797
02:35:10,758 --> 02:35:12,659
IN PARTICULAR BECAUSE TRIALS 

3798
02:35:12,659 --> 02:35:14,795
EXCLUDE THOSE WITH DISORDERED 

3799
02:35:14,795 --> 02:35:22,936
EATING OR MENTAL HEALTH 

3800
02:35:22,936 --> 02:35:33,113
DIAGNOSES.

3801
02:35:34,248 --> 02:35:36,183
SAME WITH MENTAL HEALTH 

3802
02:35:36,183 --> 02:35:36,917
DIAGNOSES.

3803
02:35:36,917 --> 02:35:39,219
WE KNOW THAT MENTAL HEALTH 

3804
02:35:39,219 --> 02:35:40,921
DIFFICULTIES ARE STRONGLY 

3805
02:35:40,921 --> 02:35:42,756
ASSOCIATE WITH OBESITY AND IT'S 

3806
02:35:42,756 --> 02:35:43,757
VERY UNCLEAR WHICH DIRECTION 

3807
02:35:43,757 --> 02:35:48,195
THAT GOES.

3808
02:35:48,195 --> 02:35:50,264
THERE'S ALSO SOME REALLY 

3809
02:35:50,264 --> 02:35:51,932
CRITICAL OUTCOMES THAT ARE 

3810
02:35:51,932 --> 02:35:53,600
EITHER POORLY ASSESSED IN 

3811
02:35:53,600 --> 02:35:55,869
TRIALS OR THAT OCCURRING AT 

3812
02:35:55,869 --> 02:35:57,404
PRETTY LOW FREQUENCIES SO IT'S 

3813
02:35:57,404 --> 02:36:00,073
HARD TO PICK THEM UP IN 

3814
02:36:00,073 --> 02:36:01,442
RELATIVELY SMALL TRIALS HERE.

3815
02:36:01,442 --> 02:36:03,610
ONE IS MENTAL HEALTH RISKS.

3816
02:36:03,610 --> 02:36:05,245
SO THIS IS IN ADDITION TO WHAT 

3817
02:36:05,245 --> 02:36:07,347
I THINK ABOUT THE GENERAL 

3818
02:36:07,347 --> 02:36:09,183
MENTAL HEALTH RISK OF OBESITY, 

3819
02:36:09,183 --> 02:36:12,753
BUT THE MENTAL HEALTH RISK OF 

3820
02:36:12,753 --> 02:36:13,587
CHANGING BODY SIZE, 

3821
02:36:13,587 --> 02:36:15,889
PARTICULARLY FOR ADOLESCENT WHO 

3822
02:36:15,889 --> 02:36:19,226
ARE A UNIQUE TIME AND THEIR 

3823
02:36:19,226 --> 02:36:20,227
UNDERSTANDING OF THEMSELVES.

3824
02:36:20,227 --> 02:36:21,895
THERE'S A LOT OF CONCERN ABOUT 

3825
02:36:21,895 --> 02:36:23,964
THE DEVELOPMENT OF EATING 

3826
02:36:23,964 --> 02:36:28,368
DISORDERS.

3827
02:36:28,368 --> 02:36:31,071
AND INDEED, GLP-1'S CERTAINLY 

3828
02:36:31,071 --> 02:36:32,773
LIMIT INTAKE OF FOOD.

3829
02:36:32,773 --> 02:36:34,875
BUT WHETHER THAT IS RESTRICTIVE 

3830
02:36:34,875 --> 02:36:38,145
INTAKE IN TERMS OF WHAT IS 

3831
02:36:38,145 --> 02:36:40,247
DRIVING THAT REDUCED INTAKE MAY 

3832
02:36:40,247 --> 02:36:42,349
OR MAY NOT BE SOMETHING WE 

3833
02:36:42,349 --> 02:36:45,118
THINK OF AS AN EATING DISORDER.

3834
02:36:45,118 --> 02:36:46,487
THERE'S ALSO REALLY IMPORTANT 

3835
02:36:46,487 --> 02:36:49,556
CONCERNS ABOUT SOCIAL 

3836
02:36:49,556 --> 02:36:49,857
DEVELOPMENT.

3837
02:36:49,857 --> 02:36:52,693
MANY OF THESE CHILDREN WILL 

3838
02:36:52,693 --> 02:36:54,161
BENEFIT HEALTH-WISE FROM 

3839
02:36:54,161 --> 02:36:55,262
SIGNIFICANT WEIGHT LOSS, 

3840
02:36:55,262 --> 02:36:58,031
ESPECIALLY AS A TRAJECTORY INTO 

3841
02:36:58,031 --> 02:37:00,868
ADULTHOOD.

3842
02:37:00,868 --> 02:37:04,404
BUT THEY ARE A PART OF COMPLEX 

3843
02:37:04,404 --> 02:37:05,706
ADOLESCENT SOCIAL GROUPS AND 

3844
02:37:05,706 --> 02:37:06,974
WHAT HAPPENS TO THEIR SOCIAL 

3845
02:37:06,974 --> 02:37:07,574
DEVELOPMENT.

3846
02:37:07,574 --> 02:37:09,209
IS THAT GOOD OR BAD?

3847
02:37:09,209 --> 02:37:14,581
WE DON'T REALLY KNOW.

3848
02:37:14,581 --> 02:37:17,484
A FEW CAUTIONS, AS WE THINK 

3849
02:37:17,484 --> 02:37:19,853
ABOUT USING EVIDENCE OUTSIDE OF 

3850
02:37:19,853 --> 02:37:21,455
THESE TRIALS.

3851
02:37:21,455 --> 02:37:25,792
ONE IS A REALLY IMPORTANT 

3852
02:37:25,792 --> 02:37:26,593
UNOBSERVED EXPOSURE.

3853
02:37:26,593 --> 02:37:29,162
WE KNOW THAT COMPOUNDING IS 

3854
02:37:29,162 --> 02:37:31,465
RELATIVELY PREVALENT FOR ADULTS.

3855
02:37:31,465 --> 02:37:32,733
IT'S LESS COMMON IN CHILDREN, 

3856
02:37:32,733 --> 02:37:35,235
BUT WE KNOW IT'S HAPPENING.

3857
02:37:35,235 --> 02:37:37,304
HOW MUCH IT'S HAPPENING IS 

3858
02:37:37,304 --> 02:37:41,275
ALMOST ENTIRELY ANECDOTAL 

3859
02:37:41,275 --> 02:37:41,642
EVIDENCE THERE.

3860
02:37:41,642 --> 02:37:44,177
EVEN THOUGH THAT IS PROBABLY 

3861
02:37:44,177 --> 02:37:46,013
LESS LIKELY TO BE A PROBLEM 

3862
02:37:46,013 --> 02:37:48,215
MOVING FORWARD, WE HAVE 2-3 

3863
02:37:48,215 --> 02:37:50,784
YEARS, IF WE ARE LOOKING FOR 

3864
02:37:50,784 --> 02:37:52,452
EXAMPLE, EHR DATA WHERE 

3865
02:37:52,452 --> 02:37:53,720
COMPOUNDING MIGHT BE SOMETHING 

3866
02:37:53,720 --> 02:37:55,322
THESE KIDS ARE USING, SO WE 

3867
02:37:55,322 --> 02:37:58,759
WOULDN'T BE ABLE TO IDENTIFY 

3868
02:37:58,759 --> 02:37:59,526
THOSE EXPOSURES.

3869
02:37:59,526 --> 02:38:02,129
THERE'S ALSO JUST SO MUCH OTHER 

3870
02:38:02,129 --> 02:38:03,263
UNOBSERVED INFORMATION.

3871
02:38:03,263 --> 02:38:04,932
KIDS MOVE IN AND OUT OF 

3872
02:38:04,932 --> 02:38:07,668
TREATMENT A LOT.

3873
02:38:07,668 --> 02:38:10,571
THERE'S ALSO VERY FEW 

3874
02:38:10,571 --> 02:38:12,039
PRESCRIBERS OF GLP-1'S FOR 

3875
02:38:12,039 --> 02:38:13,507
ADOLESCENTS SO THEY ARE OFTEN 

3876
02:38:13,507 --> 02:38:15,776
NOT IN THE SAME SYSTEM AS THEIR 

3877
02:38:15,776 --> 02:38:16,977
PRIMARY CARE PHYSICIAN.

3878
02:38:16,977 --> 02:38:18,645
WHICH MEANS YOU LOSE A LOT OF 

3879
02:38:18,645 --> 02:38:20,514
DATA IF THOSE SYSTEMS ARE NOT 

3880
02:38:20,514 --> 02:38:22,382
TALKING TO EACH OTHER.

3881
02:38:22,382 --> 02:38:23,784
FOR EXAMPLE, WHERE WE ARE, WE 

3882
02:38:23,784 --> 02:38:25,886
HAVE TWO VERY LARGE MEDICAL 

3883
02:38:25,886 --> 02:38:27,120
CENTERS NEXT TO EACH OTHER.

3884
02:38:27,120 --> 02:38:31,058
ONLY ONE OF THOSE HAS AN 

3885
02:38:31,058 --> 02:38:32,626
OBESITY TREATMENT PROGRAM.

3886
02:38:32,626 --> 02:38:33,594
AND THAT PROGRAM IS THE ONLY 

3887
02:38:33,594 --> 02:38:38,398
ONE WE ARE AWARE OF THAT 

3888
02:38:38,398 --> 02:38:40,534
ACTUALLY PRESCRIBES GLP-1'S TO 

3889
02:38:40,534 --> 02:38:40,834
ADOLESCENTS.

3890
02:38:40,834 --> 02:38:42,536
SO HALF OF THE POPULATION MAY 

3891
02:38:42,536 --> 02:38:44,805
BE SEEN IN ONE SYSTEM BUT COME 

3892
02:38:44,805 --> 02:38:46,406
TO ANOTHER SYSTEM TO RECEIVE 

3893
02:38:46,406 --> 02:38:47,774
THESE MEDICATIONS.

3894
02:38:47,774 --> 02:38:50,010
AND AS IS TRUE FOR ADULTS, AS 

3895
02:38:50,010 --> 02:38:51,845
WELL AS CHILDREN, OBESITY IS 

3896
02:38:51,845 --> 02:38:53,880
JUST AFFECTED BY SO MANY THINGS 

3897
02:38:53,880 --> 02:38:55,115
OUTSIDE THE HEALTH CARE SYSTEM.

3898
02:38:55,115 --> 02:38:58,051
THERE ARE SO MANY EXPOSURES WE 

3899
02:38:58,051 --> 02:39:00,120
JUST ARE NOT EVER GOING TO BE 

3900
02:39:00,120 --> 02:39:02,856
ABLE TO MEASURE IN THE WAY WE 

3901
02:39:02,856 --> 02:39:06,727
TYPICALLY USE REAL-WORLD 

3902
02:39:06,727 --> 02:39:06,994
EVIDENCE.

3903
02:39:06,994 --> 02:39:08,695
SO WHAT ARE THE MAJOR GAPS AND 

3904
02:39:08,695 --> 02:39:10,097
OPPORTUNITIES HERE?

3905
02:39:10,097 --> 02:39:13,433
ONE IS TO UNDERSTAND LONG-TERM 

3906
02:39:13,433 --> 02:39:13,700
OUTCOMES.

3907
02:39:13,700 --> 02:39:17,004
WE HAVE OUTCOMES UP TO, I 

3908
02:39:17,004 --> 02:39:18,839
BELIEVE, 62 WEEKS AT THIS POINT.

3909
02:39:18,839 --> 02:39:21,942
WE DO KNOW THAT WEIGHT REGAIN 

3910
02:39:21,942 --> 02:39:23,443
HAPPENS QUICKLY UPON 

3911
02:39:23,443 --> 02:39:24,878
DISCONTINUATION.

3912
02:39:24,878 --> 02:39:26,780
BUT WE DON'T KNOW WHAT HAPPENS 

3913
02:39:26,780 --> 02:39:28,382
IF CHILDREN ARE ON THESE FOR A 

3914
02:39:28,382 --> 02:39:30,484
VERY LONG TIME.

3915
02:39:30,484 --> 02:39:32,786
AND YOU KNOW, THAT IS ONE OF 

3916
02:39:32,786 --> 02:39:34,421
THE BIGGEST CONCERNS THAT 

3917
02:39:34,421 --> 02:39:37,524
PARENTS OFTEN HAVE WITH THIS.

3918
02:39:37,524 --> 02:39:40,460
WE ALSO DON'T KNOW MUCH ABOUT 

3919
02:39:40,460 --> 02:39:42,529
MANAGEMENT OVER TIME.

3920
02:39:42,529 --> 02:39:44,131
LOOKING AT WHAT ACTUALLY 

3921
02:39:44,131 --> 02:39:45,832
HAPPENS IN CLINICAL PRACTICE, 

3922
02:39:45,832 --> 02:39:47,434
WHERE YOU KNOW, CHILDREN DO 

3923
02:39:47,434 --> 02:39:48,935
START AND THEN PERHAPS STOP.

3924
02:39:48,935 --> 02:39:50,037
OR MAYBE THERE'S A DIFFERENT 

3925
02:39:50,037 --> 02:39:53,140
DOSE ESCALATION CHOSEN BY THE 

3926
02:39:53,140 --> 02:39:54,174
CLINICIAN FOR WHATEVER REASON, 

3927
02:39:54,174 --> 02:39:56,476
WE MIGHT BE ABLE TO LEARN A LOT 

3928
02:39:56,476 --> 02:39:58,712
ABOUT DIFFERENT APPROACHES THAT 

3929
02:39:58,712 --> 02:40:00,080
CAN PROVIDE EFFECTIVENESS WHILE 

3930
02:40:00,080 --> 02:40:01,214
LIMITING HARMS.

3931
02:40:01,214 --> 02:40:03,517
AND BEING ABLE TO ASSESS THOSE 

3932
02:40:03,517 --> 02:40:06,253
HARMS IS ONE OF THOSE GAPS AND 

3933
02:40:06,253 --> 02:40:07,921
OPPORTUNITIES AS WELL.

3934
02:40:07,921 --> 02:40:09,356
THERE'S SOME THAT ARE 

3935
02:40:09,356 --> 02:40:10,390
PARTICULARLY UNIQUE TO 

3936
02:40:10,390 --> 02:40:14,394
CHILDREN, HAVING TO DO WITH THE 

3937
02:40:14,394 --> 02:40:18,331
SOCIAL DEVELOPMENT IN ADDITION 

3938
02:40:18,331 --> 02:40:20,100
TO SOME CONCERNS OF EATING 

3939
02:40:20,100 --> 02:40:21,601
DISORDERS AND WHAT THEY LOOK 

3940
02:40:21,601 --> 02:40:23,036
LIKE IN TEENAGERS.

3941
02:40:23,036 --> 02:40:25,539
SO JUST TO SUMMARIZE AND END 

3942
02:40:25,539 --> 02:40:27,207
HERE, THERE'S A LOT OF 

3943
02:40:27,207 --> 02:40:28,241
EVIDENCE, A LOT OF 

3944
02:40:28,241 --> 02:40:30,744
OPPORTUNITIES FOR THE USE OF 

3945
02:40:30,744 --> 02:40:34,781
REAL-WORLD EVIDENCE, EVEN 

3946
02:40:34,781 --> 02:40:38,318
THOUGH IN THE CPG MOST RECEPTLY 

3947
02:40:38,318 --> 02:40:41,088
PUBLISHED WE HAD TO FOCUS ON 

3948
02:40:41,088 --> 02:40:41,955
RANDOMIZED TRIALS BECAUSE 

3949
02:40:41,955 --> 02:40:44,791
THAT'S ALL THAT WAS AVAILABLE.

3950
02:40:44,791 --> 02:40:46,326
I EXPECT MUCH OF THIS DATA WILL 

3951
02:40:46,326 --> 02:40:47,761
BE MUCH MORE USEFUL AS WE MOVE 

3952
02:40:47,761 --> 02:40:57,938
FORWARD.

3953
02:40:57,938 --> 02:41:04,111
>> Christina Wee: THANK
YOU, SO 

3954
02:41:04,111 --> 02:41:05,912
NOW WE WILL GO TO THE QUESTION 

3955
02:41:05,912 --> 02:41:06,780
AND ANSWER SECTION OF OUR 

3956
02:41:06,780 --> 02:41:07,781
PRESENTATION.

3957
02:41:07,781 --> 02:41:10,016
I HAVE A COUPLE QUESTIONS IN 

3958
02:41:10,016 --> 02:41:13,120
THE CHAT DIRECTED AT DR. 

3959
02:41:13,120 --> 02:41:13,353
BRADLEY.

3960
02:41:13,353 --> 02:41:15,021
THE FIRST QUESTION HAS TO DO 

3961
02:41:15,021 --> 02:41:18,625
WITH HOW THE FDA SELECTS 

3962
02:41:18,625 --> 02:41:21,595
TOPICS, IN TERMS OF USING 

3963
02:41:21,595 --> 02:41:31,938
REAL-WORLD EVIDENCE?

3964
02:41:36,309 --> 02:41:38,245
>> Marie Bradley: THAT'S A
GOOD 

3965
02:41:38,245 --> 02:41:41,448
QUESTION.

3966
02:41:41,448 --> 02:41:42,315
FOR RESEARCH INITIATIVES, 

3967
02:41:42,315 --> 02:41:44,384
USUALLY COME UP WHEN WE ARE 

3968
02:41:44,384 --> 02:41:45,318
REVIEWING SUBMISSIONS.

3969
02:41:45,318 --> 02:41:47,220
WE ALSO RELY HEAVILY ON 

3970
02:41:47,220 --> 02:41:50,257
FEEDBACK FROM EXTERNAL PARTIES 

3971
02:41:50,257 --> 02:41:52,125
THAT COME TO US AND SAY THESE 

3972
02:41:52,125 --> 02:41:53,894
ARE THE ISSUES WE ARE FACING.

3973
02:41:53,894 --> 02:41:56,863
AND ALSO THE LITERATURE, RIGHT?

3974
02:41:56,863 --> 02:41:58,398
ANY KIND OF ISSUES THAT MIGHT 

3975
02:41:58,398 --> 02:41:59,766
BE RAISED IN THE LITERATURE 

3976
02:41:59,766 --> 02:42:02,269
THAT COULD BE RELEVANT TO THE 

3977
02:42:02,269 --> 02:42:05,605
USE OF REAL-WORLD DATA AND 

3978
02:42:05,605 --> 02:42:06,106
REGULATORY SUBMISSIONS.

3979
02:42:06,106 --> 02:42:09,476
IF WE ARE CONCERNED, HAVE 

3980
02:42:09,476 --> 02:42:11,111
SPECIFIC CONCERNS WE CAN PUT 

3981
02:42:11,111 --> 02:42:13,146
OUT REQUESTS FOR PROPOSALS.

3982
02:42:13,146 --> 02:42:16,750
WE WOULD DO THAT THROUGH 

3983
02:42:16,750 --> 02:42:18,752
POTENTIALLY SOLICITED FOR  --  

3984
02:42:18,752 --> 02:42:19,452
MECHANISMS.

3985
02:42:19,452 --> 02:42:23,223
WE CURRENTLY HAVE FOUR, OR 

3986
02:42:23,223 --> 02:42:25,091
THREE, WE FUNDED FOUR IN 2023 

3987
02:42:25,091 --> 02:42:29,930
AND ONE HAS WRAPPED UP.

3988
02:42:29,930 --> 02:42:36,636
AND INVESTIGATING VARIOUS 

3989
02:42:36,636 --> 02:42:37,270
METHODOLOGIC CHALLENGES WITH 

3990
02:42:37,270 --> 02:42:38,138
DECISION MAKING.

3991
02:42:38,138 --> 02:42:40,006
WE HAVE FIVE CENTERS FOR 

3992
02:42:40,006 --> 02:42:41,675
EXCELLENCE IN REGULATORY 

3993
02:42:41,675 --> 02:42:41,908
SCIENCE.

3994
02:42:41,908 --> 02:42:46,046
SO WE CAN PUT OUT REQUESTS FOR 

3995
02:42:46,046 --> 02:42:48,481
PROPOSALS IF WE HAVE SPECIFIC 

3996
02:42:48,481 --> 02:42:49,783
TARGETED INTERESTS.

3997
02:42:49,783 --> 02:42:51,251
WE ALSO, AT THE AGENCY, HAVE 

3998
02:42:51,251 --> 02:42:54,921
WHAT WE CALL A BROAD 

3999
02:42:54,921 --> 02:42:55,822
ANNOUNCEMENT.

4000
02:42:55,822 --> 02:42:58,792
THAT'S MUCH MORE BROAD WE WOULD 

4001
02:42:58,792 --> 02:43:01,127
INVITE INTERESTED PARTIES TO 

4002
02:43:01,127 --> 02:43:02,896
SUBMIT PROPOSALS AND PROJECT 

4003
02:43:02,896 --> 02:43:04,998
IDEAS FOR THINGS THEY THINK ARE 

4004
02:43:04,998 --> 02:43:06,399
VERY PERTINENT IN THE AREA.

4005
02:43:06,399 --> 02:43:09,069
SO USING THOSE KIND OF 

4006
02:43:09,069 --> 02:43:09,502
MECHANISMS.

4007
02:43:09,502 --> 02:43:11,171
ALSO IF THERE IS SOMETHING MORE 

4008
02:43:11,171 --> 02:43:13,473
PRESSING WE NEED TO INVESTIGATE 

4009
02:43:13,473 --> 02:43:17,210
IN A MORE SPEEDILY MANNER, 

4010
02:43:17,210 --> 02:43:18,678
ESPECIALLY THINGS LIKE DURING A 

4011
02:43:18,678 --> 02:43:20,914
PANDEMIC SITUATION, WE WOULD 

4012
02:43:20,914 --> 02:43:22,415
HAVE INTERNAL FUNDING WE CAN 

4013
02:43:22,415 --> 02:43:23,984
FUND SOME OF OUR OWN STAFF TO 

4014
02:43:23,984 --> 02:43:27,687
DO THAT RESEARCH AS WELL.

4015
02:43:27,687 --> 02:43:33,693
AND WE HAVE OUR SENTINEL SYSTEM 

4016
02:43:33,693 --> 02:43:34,761
FOR SAFETY-RELATED INQUIRIES.

4017
02:43:34,761 --> 02:43:38,899
THAT'S KIND OF HOW IT WORKS, 

4018
02:43:38,899 --> 02:43:39,266
MOSTLY.

4019
02:43:39,266 --> 02:43:42,002
>> Christine Wee: GREAT, I
HAVE 

4020
02:43:42,002 --> 02:43:43,270
A FOLLOW-UP QUESTION.

4021
02:43:43,270 --> 02:43:45,071
YOU MENTIONED IN YOUR TALK 

4022
02:43:45,071 --> 02:43:47,774
AREAS IN THE GLP-1'S YOU WERE 

4023
02:43:47,774 --> 02:43:48,808
COLLECTING DATA ON.

4024
02:43:48,808 --> 02:43:53,146
AND I WONDER WHETHER THERE IS 

4025
02:43:53,146 --> 02:43:54,014
AN ACTIVE MONITORING OF 

4026
02:43:54,014 --> 02:43:54,581
LITERATURE.

4027
02:43:54,581 --> 02:43:56,983
BECAUSE SOME OF THE TOPICS, I 

4028
02:43:56,983 --> 02:43:59,719
CAN IMAGINE THERE ARE OTHER 

4029
02:43:59,719 --> 02:44:01,187
INVESTIGATIVE, INDEPENDENT 

4030
02:44:01,187 --> 02:44:02,255
REGULATORY ASKING AND ANSWERING 

4031
02:44:02,255 --> 02:44:04,157
AND HOW MUCH OF THAT IS 

4032
02:44:04,157 --> 02:44:05,959
OVERLAPPING AND DO YOU EXTRACT.

4033
02:44:05,959 --> 02:44:08,728
OR DO YOU WAIT FOR RESEARCHERS 

4034
02:44:08,728 --> 02:44:10,463
TO SORT OF SUBMIT IT TO YOUR 

4035
02:44:10,463 --> 02:44:10,797
ATTENTION?

4036
02:44:10,797 --> 02:44:15,368
>>

4037
02:44:15,368 --> 02:44:17,270
Marie Bradley: THAT'S A GOOD 

4038
02:44:17,270 --> 02:44:17,537
QUESTION.

4039
02:44:17,537 --> 02:44:18,505
YEAH, THE RESEARCH I'M TALKING 

4040
02:44:18,505 --> 02:44:20,373
ABOUT THROUGH THE BROAD AGENCY 

4041
02:44:20,373 --> 02:44:22,008
ANNOUNCEMENTS WILL BE A LITTLE 

4042
02:44:22,008 --> 02:44:23,743
SEPARATE TO THE REVIEW SYSTEM.

4043
02:44:23,743 --> 02:44:25,779
SO THE WAY IT WOULD WORK IN 

4044
02:44:25,779 --> 02:44:28,381
FDA, IF THERE'S A CONCERN WITH 

4045
02:44:28,381 --> 02:44:29,649
A REGULATED PRODUCT, 

4046
02:44:29,649 --> 02:44:30,750
POTENTIALLY THERE'S A FEW 

4047
02:44:30,750 --> 02:44:33,119
STUDIES IN THE LITERATURE, WE 

4048
02:44:33,119 --> 02:44:35,422
WOULD HAVE TEAMS OF 

4049
02:44:35,422 --> 02:44:37,891
EPIDEMIOLOGISTS RUN THOROUGH 

4050
02:44:37,891 --> 02:44:39,359
SYSTEMATIC REVIEWS TO SUMMARIZE 

4051
02:44:39,359 --> 02:44:40,293
THAT EVIDENCE, TO LOOK AT THE 

4052
02:44:40,293 --> 02:44:42,862
QUALITY OF THE STUDIES, AND TO 

4053
02:44:42,862 --> 02:44:45,165
SEE IF THAT IS SOMETHING THAT 

4054
02:44:45,165 --> 02:44:47,901
WE SHOULD MOVE FORWARD WITH 

4055
02:44:47,901 --> 02:44:50,003
EITHER DOING OUR OWN STUDY, 

4056
02:44:50,003 --> 02:44:52,906
MAYBE ASKING A SPONSOR TO DO A 

4057
02:44:52,906 --> 02:44:58,545
STUDY OR PUT SOME SORT OF SEW  

4058
02:44:58,545 --> 02:45:00,013
SOLICITATION FOR PROPOSAL.

4059
02:45:00,013 --> 02:45:03,183
CERTAINLY WE KEEP ABREAST TO A 

4060
02:45:03,183 --> 02:45:06,786
PROPOSAL IF IT'S RELATED TO A 

4061
02:45:06,786 --> 02:45:07,287
PRODUCT.

4062
02:45:07,287 --> 02:45:09,055
>> Christine Wee: THANKS,
NEXT 

4063
02:45:09,055 --> 02:45:10,991
I HAVE A QUESTION FOR JOHN AND 

4064
02:45:10,991 --> 02:45:15,295
MAY ALSO BE RELEVANT TO ASHELEY.

4065
02:45:15,295 --> 02:45:19,499
YOU BRING UP THE ISSUE OF HIGH 

4066
02:45:19,499 --> 02:45:20,767
ATTRITION WITH PHARMACOLOGIC 

4067
02:45:20,767 --> 02:45:22,869
TREATMENTS FOR OBESITY AND THE 

4068
02:45:22,869 --> 02:45:23,837
RESTRICTED ELIGIBILITY 

4069
02:45:23,837 --> 02:45:27,140
CRITERIA, WHICH SORT OF SPEAKS 

4070
02:45:27,140 --> 02:45:28,341
TO GENERALIZABILITY.

4071
02:45:28,341 --> 02:45:32,445
BUT I WOULD POSIT, AN ANALOGOUS 

4072
02:45:32,445 --> 02:45:33,913
CONCERN AND ISSUE ARISES ALL 

4073
02:45:33,913 --> 02:45:37,684
THE TIME WITH THE EVALUATION OF 

4074
02:45:37,684 --> 02:45:39,252
EVIDENCE FOR BEHAVIORAL 

4075
02:45:39,252 --> 02:45:40,020
INTERVENTIONS.

4076
02:45:40,020 --> 02:45:41,187
BECAUSE WHILE SOME OF THOSE 

4077
02:45:41,187 --> 02:45:44,391
HAVE HIGH ATTRITION RATES, AND 

4078
02:45:44,391 --> 02:45:46,092
EVEN IF THEY DON'T, AS A 

4079
02:45:46,092 --> 02:45:47,327
CLINICIAN WE SORT OF KNOW UP 

4080
02:45:47,327 --> 02:45:49,996
FRONT YOU ARE REALLY STUDYING A 

4081
02:45:49,996 --> 02:45:54,567
TINY SLIVER OF THE MOST 

4082
02:45:54,567 --> 02:45:55,068
HIGHLY-MOTIVATED FOLKS.

4083
02:45:55,068 --> 02:45:56,669
THERE'S A SENSE RESULTS FROM 

4084
02:45:56,669 --> 02:45:59,406
THESE RCT'S ARE REALLY 

4085
02:45:59,406 --> 02:46:00,840
EXAGGERATED AND OVERLY 

4086
02:46:00,840 --> 02:46:02,342
OPTIMISTIC AND NOT REAL WORLD.

4087
02:46:02,342 --> 02:46:03,977
HOW DO YOU TAKE THAT INTO 

4088
02:46:03,977 --> 02:46:06,780
CONSIDERATION IN YOUR 

4089
02:46:06,780 --> 02:46:10,517
EVALUATION PROCESS?

4090
02:46:10,517 --> 02:46:12,485
>> John Wong: THE A REALLY

4091
02:46:12,485 --> 02:46:13,953
INTERESTING QUESTION.

4092
02:46:13,953 --> 02:46:18,758
WE LOOK FOR CONSISTENCY IN THE 

4093
02:46:18,758 --> 02:46:19,926
BENEFIT.

4094
02:46:19,926 --> 02:46:24,297
IN BEHAVIORAL INTERVENTIONS 

4095
02:46:24,297 --> 02:46:27,600
ALONE WITHOUT PHARMACO, 65 

4096
02:46:27,600 --> 02:46:29,069
DEMONSTRATED WEIGHT LOSS.

4097
02:46:29,069 --> 02:46:31,171
THE OTHER PIECE I WILL MENTION, 

4098
02:46:31,171 --> 02:46:33,673
THERE WAS CONSISTENCY IN TERMS 

4099
02:46:33,673 --> 02:46:35,542
OF COMPONENTS OF THOSE 

4100
02:46:35,542 --> 02:46:39,045
BEHAVIORAL INTERCONVENIENT  --  

4101
02:46:39,045 --> 02:46:40,080
INTERVENTIONS WITH REGARD TO 

4102
02:46:40,080 --> 02:46:45,652
ENERGY BALANCE, WITH REGARD TO  

4103
02:46:45,652 --> 02:46:47,287
HEALTHFUL DIETARY PATTERNS.

4104
02:46:47,287 --> 02:46:49,155
THEY EMPLOYED STANDARD 

4105
02:46:49,155 --> 02:46:50,790
BEHAVIORAL CHANGE TECHNIQUES.

4106
02:46:50,790 --> 02:46:52,759
NOW, HAVING SAID THAT, THERE 

4107
02:46:52,759 --> 02:46:55,361
WERE LIMITATIONS THAT ARE 

4108
02:46:55,361 --> 02:46:56,329
EVIDENCE REVIEW TEAM 

4109
02:46:56,329 --> 02:46:57,664
IDENTIFIED, WHICH IS THE NUMBER 

4110
02:46:57,664 --> 02:46:59,332
OF TIMES AN INTERVENTION 

4111
02:46:59,332 --> 02:47:01,768
OCCURRED, THE LENGTH OF TIME.

4112
02:47:01,768 --> 02:47:02,902
THOSE INTERVENTIONS OCCURRED.

4113
02:47:02,902 --> 02:47:07,841
AND THE DURATION OF TIME.

4114
02:47:07,841 --> 02:47:12,078
NONETHELESS, YOU KNOW, WE FOUND 

4115
02:47:12,078 --> 02:47:13,179
THIS CONSISTENT BENEFIT THERE.

4116
02:47:13,179 --> 02:47:15,381
WE FELT WE HAD STRONG INTERNAL 

4117
02:47:15,381 --> 02:47:20,353
HAVE  VALIDITY FROM RANDOMIZED 

4118
02:47:20,353 --> 02:47:21,154
CONTROL TRIALS.

4119
02:47:21,154 --> 02:47:23,456
THEY DID FIND, THE EVIDENCE 

4120
02:47:23,456 --> 02:47:25,358
REVIEW TEAM HIGH VARIABILITY IN 

4121
02:47:25,358 --> 02:47:28,261
TERMS OF REPORTING AND WE 

4122
02:47:28,261 --> 02:47:29,696
RECOMMENDED MORE CONSISTENT USE 

4123
02:47:29,696 --> 02:47:31,131
OF OUTCOME REPORTING USING 

4124
02:47:31,131 --> 02:47:33,133
EITHER A CHECKLIST OR A 

4125
02:47:33,133 --> 02:47:34,834
FRAMEWORK.

4126
02:47:34,834 --> 02:47:37,337
BUT WE APPRECIATE AND TOTALLY 

4127
02:47:37,337 --> 02:47:41,274
UNDERSTAND YOUR COMMENT.

4128
02:47:41,274 --> 02:47:43,610
>> Christine Wee: I GUESS
A 

4129
02:47:43,610 --> 02:47:46,312
FOLLOW-UP, NOT SO MUCH INTERNAL 

4130
02:47:46,312 --> 02:47:48,548
VALIDITY BUT EXTERNAL 

4131
02:47:48,548 --> 02:47:51,251
GENERALIZED, YOU COULD HAVE 65 

4132
02:47:51,251 --> 02:47:53,753
STUDIES BE CONSISTENT BUT THAT 

4133
02:47:53,753 --> 02:47:54,888
DOESN'T ADDRESS THE BIGGER 

4134
02:47:54,888 --> 02:47:55,622
ISSUE.

4135
02:47:55,622 --> 02:47:58,091
I WONDER IF, DR. SKINNER, IF 

4136
02:47:58,091 --> 02:48:01,461
YOU WOULD LIKE TO WEIGH IN, I 

4137
02:48:01,461 --> 02:48:04,531
IMAGINE THE SAME WITH KIDS.

4138
02:48:04,531 --> 02:48:06,799
>> DR. SKINNER: MOST
ASSUREDLY 

4139
02:48:06,799 --> 02:48:07,400
THE SAME ISSUE.

4140
02:48:07,400 --> 02:48:08,935
I AGREE WITH EVERYTHING JOHN 

4141
02:48:08,935 --> 02:48:09,135
SAID.

4142
02:48:09,135 --> 02:48:11,571
I THINK WE HAVE GOOD INTERNAL 

4143
02:48:11,571 --> 02:48:13,039
VALIDITY, BUT LIKE EVERY 

4144
02:48:13,039 --> 02:48:15,308
DISEASE, YOU ARE ONLY GOING TO 

4145
02:48:15,308 --> 02:48:16,543
FIND SUCCESSFUL TREATMENT 

4146
02:48:16,543 --> 02:48:17,577
AMONGST PEOPLE WHO WANT 

4147
02:48:17,577 --> 02:48:19,646
TREATMENT AND WANT TO ENGAGE IN 

4148
02:48:19,646 --> 02:48:19,913
TREATMENT.

4149
02:48:19,913 --> 02:48:23,216
AND I THINK OBESITY IS A UNIQUE 

4150
02:48:23,216 --> 02:48:25,051
ONE THAT THERE ARE OFTEN PEOPLE 

4151
02:48:25,051 --> 02:48:26,886
WHO JUST DON'T WANT TO ENGAGE 

4152
02:48:26,886 --> 02:48:27,787
IN TREATMENT.

4153
02:48:27,787 --> 02:48:30,456
SO TO TAKE A STUDY OF PEOPLE 

4154
02:48:30,456 --> 02:48:32,725
WHO ARE HIGHLY MOTIVATED AND 

4155
02:48:32,725 --> 02:48:34,160
WANT TO BE PART OF TREATMENT 

4156
02:48:34,160 --> 02:48:35,628
AND ASSUME THAT WILL WORK FOR 

4157
02:48:35,628 --> 02:48:37,497
PEOPLE WHO DON'T WANT TO ENGAGE 

4158
02:48:37,497 --> 02:48:40,033
IN TREATMENT, OF COURSE THAT'S 

4159
02:48:40,033 --> 02:48:42,769
NOT GOING TO TRANSLATE IN THE 

4160
02:48:42,769 --> 02:48:44,904
SAME WAY.

4161
02:48:44,904 --> 02:48:46,973
IN TERMS OF RIGHT POPULATIONS 

4162
02:48:46,973 --> 02:48:48,241
WHO CAN BENEFIT FROM THIS, I 

4163
02:48:48,241 --> 02:48:53,012
THINK THE CONSISTENCY WE SEE, 

4164
02:48:53,012 --> 02:48:53,846
ESPECIALLY IN LIFESTYLE 

4165
02:48:53,846 --> 02:48:55,915
TREATMENT, FOR PEOPLE WHO WANT 

4166
02:48:55,915 --> 02:48:59,285
IT, IT CAN BE EFFECTIVE.

4167
02:48:59,285 --> 02:49:00,787
>> CHRISTINE WEE: THANK
YOU.

4168
02:49:00,787 --> 02:49:02,822
I WOULD ALSO BE CAUTIOUS ABOUT 

4169
02:49:02,822 --> 02:49:05,091
MAKING SURE WE AREN'T INFERRING 

4170
02:49:05,091 --> 02:49:06,993
THAT JUST BECAUSE SOMEONE CAN'T 

4171
02:49:06,993 --> 02:49:09,128
COMPLY BECAUSE, YOU KNOW, THESE 

4172
02:49:09,128 --> 02:49:10,964
INTENSIVE TREATMENTS ARE VERY 

4173
02:49:10,964 --> 02:49:11,998
TIME CONSUMING DOESN'T MEAN 

4174
02:49:11,998 --> 02:49:13,733
THEY DON'T WANT IT, IT'S JUST 

4175
02:49:13,733 --> 02:49:15,268
MAYBE THEY DON'T HAVE THE 

4176
02:49:15,268 --> 02:49:17,737
RESOURCES OR THE TIME.

4177
02:49:17,737 --> 02:49:20,974
THERE'S A QUESTION IN THE CHAT 

4178
02:49:20,974 --> 02:49:23,509
FOR YOU, DR. WONG, BY ONE OF 

4179
02:49:23,509 --> 02:49:25,378
THE ORGANIZERS, SO I DON'T HAVE 

4180
02:49:25,378 --> 02:49:27,013
THE IDENTITY OF THE PERSON.

4181
02:49:27,013 --> 02:49:29,882
YOU MENTIONED THE USPSTF CITED 

4182
02:49:29,882 --> 02:49:32,819
LACK OF DATA OF IMPROVEMENT 

4183
02:49:32,819 --> 02:49:34,487
AFTER DISCONTINUATION OF 

4184
02:49:34,487 --> 02:49:35,888
PHARMACOTHERAPY AS A CONCERN.

4185
02:49:35,888 --> 02:49:40,927
I GUESS I WOULD ALSO CONCUR 

4186
02:49:40,927 --> 02:49:42,595
WITH THIS QUESTIONER ABOUT, ARE 

4187
02:49:42,595 --> 02:49:45,331
WE REALLY HOLDING OBESITY 

4188
02:49:45,331 --> 02:49:46,766
PHARMACOLOGIC THERAPY TO A 

4189
02:49:46,766 --> 02:49:48,201
HIGHER STANDARD THAN WE WOULD 

4190
02:49:48,201 --> 02:49:49,969
WITH ANY OTHER TREATMENT FOR 

4191
02:49:49,969 --> 02:49:50,903
CHRONIC DISEASE?

4192
02:49:50,903 --> 02:49:55,742
WE DON'T ASK THE QUESTION ARE 

4193
02:49:55,742 --> 02:49:58,278
WE CONCERNED IF WE STOP THIS 

4194
02:49:58,278 --> 02:49:59,312
BLOOD PRESSURE MEDICATION THERE 

4195
02:49:59,312 --> 02:50:01,214
WOULD BE RETURN OF HYPERTENSION 

4196
02:50:01,214 --> 02:50:02,181
OR DIABETES.

4197
02:50:02,181 --> 02:50:06,786
SO WHY ARE WE SETTING A 

4198
02:50:06,786 --> 02:50:13,593
DIFFERENT BAR?

4199
02:50:13,593 --> 02:50:15,261
>> JOHN WONG: I WOULDN'T
SAY 

4200
02:50:15,261 --> 02:50:17,697
THAT'S NOT THE REASON WE DIDN'T 

4201
02:50:17,697 --> 02:50:18,631
HAVE EVIDENCE.

4202
02:50:18,631 --> 02:50:20,466
WE DIDN'T HAVE HEALTH OUTCOME 

4203
02:50:20,466 --> 02:50:21,701
FOR THAT, THAT WAS THE 

4204
02:50:21,701 --> 02:50:22,735
RATIONALE FOR THAT.

4205
02:50:22,735 --> 02:50:24,971
I WILL ADD, JUST TO SUPPORT 

4206
02:50:24,971 --> 02:50:28,107
SOME OF THE SUBSEQUENT 

4207
02:50:28,107 --> 02:50:30,009
SPEAKERS, YOU KNOW, AS I 

4208
02:50:30,009 --> 02:50:32,111
MENTIONED WE HIGHLY VALUE 

4209
02:50:32,111 --> 02:50:33,546
PRAGMATIC TRIALS TO HELP WITH 

4210
02:50:33,546 --> 02:50:35,648
EXTERNAL VALIDITY.

4211
02:50:35,648 --> 02:50:37,517
THE OTHER POINT I WOULD MAKE 

4212
02:50:37,517 --> 02:50:40,053
IS, WE HAVE USED TRIAL 

4213
02:50:40,053 --> 02:50:41,587
EMULATION STUDIES AS PART OF 

4214
02:50:41,587 --> 02:50:43,623
EVIDENCE, WHEN WE DON'T HAVE 

4215
02:50:43,623 --> 02:50:45,692
ANY RANDOMIZED CONTROL TRIALS.

4216
02:50:45,692 --> 02:50:47,827
AND SO, OUR EVIDENCE REVIEW 

4217
02:50:47,827 --> 02:50:50,496
PRACTICE TEAMS HAVE RECENTLY 

4218
02:50:50,496 --> 02:50:51,531
PUBLISHED RECOMMENDATIONS FOR 

4219
02:50:51,531 --> 02:50:54,434
HOW TO INCORPORATE 

4220
02:50:54,434 --> 02:50:55,935
NON-RANDOMIZED STUDY 

4221
02:50:55,935 --> 02:50:57,370
INTERVENTIONS INTO EVIDENCE.

4222
02:50:57,370 --> 02:50:59,906
EVEN WHEN WE MAY HAVE SOME 

4223
02:50:59,906 --> 02:51:00,540
RANDOMIZED CONTROL TRIAL 

4224
02:51:00,540 --> 02:51:01,207
EVIDENCE.

4225
02:51:01,207 --> 02:51:03,810
I THINK THOSE ARE ALL HELPFUL, 

4226
02:51:03,810 --> 02:51:05,111
POTENTIALLY HELPFUL FOR HELPING 

4227
02:51:05,111 --> 02:51:07,580
US BRIDGE THAT INTERNAL TO 

4228
02:51:07,580 --> 02:51:10,683
EXTERNAL VALIDITY.

4229
02:51:10,683 --> 02:51:12,352
AS A PRACTICING CLINICIAN I'M 

4230
02:51:12,352 --> 02:51:17,557
WELL AWARE OF.

4231
02:51:17,557 --> 02:51:19,258
BUT NONETHELESS IF WE FIND 

4232
02:51:19,258 --> 02:51:21,694
INTERNAL VALIDITY, IT'S WORTH 

4233
02:51:21,694 --> 02:51:23,162
MENTIONING TO PATIENTS.

4234
02:51:23,162 --> 02:51:24,364
>> CHRISTINE WEE: WE HAVE
A 

4235
02:51:24,364 --> 02:51:27,300
QUESTION IN THE CHAT FOR DR. 

4236
02:51:27,300 --> 02:51:28,735
SKINNER FROM VIRGINIA RAY, WHAT 

4237
02:51:28,735 --> 02:51:31,571
DO YOU THINK ARE THE MAIN 

4238
02:51:31,571 --> 02:51:35,508
REASONS PCP'S ARE SO RELUCTANT 

4239
02:51:35,508 --> 02:51:38,644
TO PRESCRIBE IN ADOLESCENCE?

4240
02:51:38,644 --> 02:51:40,313
>> DR. SKINNER: YEAH, I
THINK 

4241
02:51:40,313 --> 02:51:43,616
FOR THE MOST PART, AND THIS IS 

4242
02:51:43,616 --> 02:51:45,084
ALL ANECDOTAL EXPERIENCE, AND 

4243
02:51:45,084 --> 02:51:47,987
I'M NOT A CLINICIAN, THIS IS ME 

4244
02:51:47,987 --> 02:51:50,256
WATCHING CLINICIANS.

4245
02:51:50,256 --> 02:51:52,125
THEY FEEL THE SITUATION SHOULD 

4246
02:51:52,125 --> 02:51:54,026
BE MANAGED BY A SPECIALIST.

4247
02:51:54,026 --> 02:51:56,562
THERE'S A LOT OF CONCERN ABOUT 

4248
02:51:56,562 --> 02:51:58,765
THEY DON'T LIKE PRESCRIBING AN 

4249
02:51:58,765 --> 02:51:59,098
INJECTION.

4250
02:51:59,098 --> 02:52:01,534
THEY WOULD RATHER HAVE A CHILD 

4251
02:52:01,534 --> 02:52:02,368
RECEIVING THESE MEDICATIONS 

4252
02:52:02,368 --> 02:52:04,871
ALSO BE PART OF INTENSIVE 

4253
02:52:04,871 --> 02:52:06,139
LIFESTYLE TREATMENT WHICH 

4254
02:52:06,139 --> 02:52:07,373
USUALLY DOESN'T HAPPEN WITHIN 

4255
02:52:07,373 --> 02:52:08,808
THE PRIMARY CARE OFFICE.

4256
02:52:08,808 --> 02:52:11,544
IT HAPPENS IN SOME OTHER AREA.

4257
02:52:11,544 --> 02:52:14,080
I THINK THEY ARE REALLY NEW.

4258
02:52:14,080 --> 02:52:18,418
OUR SEMAGLUTIDE TRIAL IS ONLY 

4259
02:52:18,418 --> 02:52:20,853
2-3 YEARS OLD AND WE DON'T HAVE 

4260
02:52:20,853 --> 02:52:22,522
ONE FOR TIRZEPATIDE YET.

4261
02:52:22,522 --> 02:52:23,656
FOR ADOLESCENCE, THAT'S A REAL 

4262
02:52:23,656 --> 02:52:24,323
ISSUE.

4263
02:52:24,323 --> 02:52:25,391
AND THE LACK OF INFORMATION 

4264
02:52:25,391 --> 02:52:27,260
ABOUT HOW TO MANAGE IT 

4265
02:52:27,260 --> 02:52:28,694
LONG-TERM AS A CHRONIC 

4266
02:52:28,694 --> 02:52:31,597
CONDITION, I THINK IS REALLY 

4267
02:52:31,597 --> 02:52:34,500
CONCERNING FOR PEDIATRICIANS.

4268
02:52:34,500 --> 02:52:35,968
IN GENERAL, PEDIATRICIANS ARE 

4269
02:52:35,968 --> 02:52:39,071
MUCH MORE CAUTIOUS WITH 

4270
02:52:39,071 --> 02:52:40,740
MEDICATIONS THAN OFTEN INTERNAL 

4271
02:52:40,740 --> 02:52:42,275
MEDICINE OR OTHER ADULT 

4272
02:52:42,275 --> 02:52:44,610
PHYSICIANS CAN BE.

4273
02:52:44,610 --> 02:52:46,679
BUT THAT'S MY EXPERIENCE.

4274
02:52:46,679 --> 02:52:48,080
>> CHRISTINE WEE: I THINK
THAT 

4275
02:52:48,080 --> 02:52:49,015
MAKES SENSE.

4276
02:52:49,015 --> 02:52:55,555
SO I HAVE A QUESTION YOU 

4277
02:52:55,555 --> 02:52:57,623
MENTIONED AND DR. BRADLEY DID 

4278
02:52:57,623 --> 02:52:59,692
TOO, YOU MENTIONED THE LACK OF 

4279
02:52:59,692 --> 02:53:00,726
HIGH QUALITY REAL-WORLD 

4280
02:53:00,726 --> 02:53:02,361
EVIDENCE IN KIDS BECAUSE OF 

4281
02:53:02,361 --> 02:53:04,864
JUST THE REALITIES OF COVERAGE 

4282
02:53:04,864 --> 02:53:06,766
AND PRACTICE TRANSITIONS AND SO 

4283
02:53:06,766 --> 02:53:07,166
FORTH.

4284
02:53:07,166 --> 02:53:09,302
WHAT DO YOU THINK ARE SOME, YOU 

4285
02:53:09,302 --> 02:53:11,671
KNOW, IF YOU COULD HAVE 

4286
02:53:11,671 --> 02:53:13,139
ANYTHING ON YOUR WISH LIST, 

4287
02:53:13,139 --> 02:53:15,475
WHAT DO YOU THINK WE WOULD 

4288
02:53:15,475 --> 02:53:17,443
REALLY NEED TO SORT OF BRIDGE 

4289
02:53:17,443 --> 02:53:18,144
THAT GAP?

4290
02:53:18,144 --> 02:53:22,315
DO YOU SEE A ROLE FOR 

4291
02:53:22,315 --> 02:53:24,016
STAKEHOLDERS, HEALTH PAYERS TO 

4292
02:53:24,016 --> 02:53:26,953
PRODUCE OR PROVIDE INCENTIVES 

4293
02:53:26,953 --> 02:53:28,488
FOR THE COLLECTION OF THIS 

4294
02:53:28,488 --> 02:53:34,193
DATA, WHETHER IT BE REG 

4295
02:53:34,193 --> 02:53:35,828
-REGISTRIES?

4296
02:53:35,828 --> 02:53:37,730
>> DR. SKINNER: REGISTRIES
ARE 

4297
02:53:37,730 --> 02:53:39,098
A PARTICULARLY STRONG IDEA HERE.

4298
02:53:39,098 --> 02:53:40,733
I THINK CERTAINLY AT LEAST 

4299
02:53:40,733 --> 02:53:44,871
RIGHT NOW, GIVEN THE COSTS OF 

4300
02:53:44,871 --> 02:53:48,341
THESE MEDICATIONS THERE SHOULD 

4301
02:53:48,341 --> 02:53:50,710
BE INCENTIVES FOR INSURERS TO 

4302
02:53:50,710 --> 02:53:52,378
IDENTIFY WHO WOULD BENEFIT FROM 

4303
02:53:52,378 --> 02:53:54,146
THESE MEDICATIONS.

4304
02:53:54,146 --> 02:53:55,581
ARE THERE POPULATIONS WE SHOULD 

4305
02:53:55,581 --> 02:53:57,049
BE MORE HESITANT ABOUT, OR 

4306
02:53:57,049 --> 02:53:59,519
SHOULD FACILITATE ACCESS TO 

4307
02:53:59,519 --> 02:54:01,187
MORE RATHER THAN USING THE LACK 

4308
02:54:01,187 --> 02:54:02,622
OF THEIR INCLUSION IN A TRIAL 

4309
02:54:02,622 --> 02:54:04,156
AS A REASON TO PREVENT THEM 

4310
02:54:04,156 --> 02:54:07,527
THERE.

4311
02:54:07,527 --> 02:54:10,229
I THINK, YOU KNOW, MORE 

4312
02:54:10,229 --> 02:54:12,698
FOLLOW-UP BY THE POST-MARKETING 

4313
02:54:12,698 --> 02:54:14,400
SURVEILLANCE BY THE 

4314
02:54:14,400 --> 02:54:15,668
PHARMACEUTICAL COMPANIES COULD 

4315
02:54:15,668 --> 02:54:16,903
BE PARTICULARLY USEFUL AND 

4316
02:54:16,903 --> 02:54:20,840
COULD BENEFIT THEM.

4317
02:54:20,840 --> 02:54:22,742
IT COULD HELP THEM DETERMINE 

4318
02:54:22,742 --> 02:54:25,278
WHICH POPULATIONS THAT'S USEFUL 

4319
02:54:25,278 --> 02:54:25,444
FOR.

4320
02:54:25,444 --> 02:54:27,179
I'M NOT ENTIRELY SURE, BUT I 

4321
02:54:27,179 --> 02:54:28,447
SUSPECT THE APPROACH TO THAT 

4322
02:54:28,447 --> 02:54:30,816
MIGHT BE DIFFERENT IN 

4323
02:54:30,816 --> 02:54:31,851
PEDIATRICIANS, VERSUS ADULT 

4324
02:54:31,851 --> 02:54:34,320
MEDICINE AND WHAT THAT MIGHT 

4325
02:54:34,320 --> 02:54:36,822
LOOK LIKE EXACTLY.

4326
02:54:36,822 --> 02:54:38,524
>> CHRISTINE WEE: JUST TO 

4327
02:54:38,524 --> 02:54:39,992
FOLLOW-UP WITH DR. BRADLEY.

4328
02:54:39,992 --> 02:54:42,094
I DIDN'T SEE THAT LISTED AS 

4329
02:54:42,094 --> 02:54:44,997
PART OF THE PORTFOLIO.

4330
02:54:44,997 --> 02:54:46,832
IS THAT SOMETHING THE FDA IS 

4331
02:54:46,832 --> 02:54:50,770
DOING, IF YOU CAN ANSWER THAT 

4332
02:54:50,770 --> 02:54:52,605
QUESTION.

4333
02:54:52,605 --> 02:54:54,307
>> MARIE BRADLEY: YOU MEAN

4334
02:54:54,307 --> 02:54:55,341
MONITORING IN KIDS?

4335
02:54:55,341 --> 02:54:59,779
YEAH, I'M NOT AWARE THERE'S 

4336
02:54:59,779 --> 02:55:02,081
ANY, THE TWO SAFETY STUDIES 

4337
02:55:02,081 --> 02:55:03,783
THAT ARE CURRENTLY ONGOING, I'M 

4338
02:55:03,783 --> 02:55:07,453
NOT AWARE OF MANY OTHER EFFORTS 

4339
02:55:07,453 --> 02:55:08,321
IN MONITORING SAFETY.

4340
02:55:08,321 --> 02:55:14,360
BUT I DON'T WORK IN THE OFFICE 

4341
02:55:14,360 --> 02:55:16,495
OF SCIENCE AND EPIDEMIOLOGY SO 

4342
02:55:16,495 --> 02:55:18,097
I'M NOT AWARE OF ANY PLANS FOR 

4343
02:55:18,097 --> 02:55:19,565
THAT RIGHT NOW.

4344
02:55:19,565 --> 02:55:21,434
>> CHRISTINE WEE: WE HAVE
A 

4345
02:55:21,434 --> 02:55:24,170
QUESTION DIRECTED TO DR. WONG 

4346
02:55:24,170 --> 02:55:25,404
FROM SUE YANOVSKI.

4347
02:55:25,404 --> 02:55:29,275
REGARDING THE TASK FORCE 

4348
02:55:29,275 --> 02:55:32,378
RECOMMENDATIONS WHICH I THINK 

4349
02:55:32,378 --> 02:55:37,717
WERE PUBLISHED IN 2018.

4350
02:55:37,717 --> 02:55:39,452
THERE'S MORE EVIDENCE ON 

4351
02:55:39,452 --> 02:55:40,453
CARDIOVASCULAR ENDPOINTS.

4352
02:55:40,453 --> 02:55:42,154
DO YOU HAVE ANY INDICATION WHEN 

4353
02:55:42,154 --> 02:55:44,290
THERE MIGHT BE AN UPDATE TO 

4354
02:55:44,290 --> 02:55:46,892
THOSE GUIDELINES?

4355
02:55:46,892 --> 02:55:50,029
>> JOHN WONG: WE ARE
DEFINITELY 

4356
02:55:50,029 --> 02:55:50,830
UPDATING OUR BEHAVIORAL 

4357
02:55:50,830 --> 02:55:52,098
RECOMMENDATION STATEMENT.

4358
02:55:52,098 --> 02:55:55,434
I WILL JUST EMPHASIZE, IT'S 

4359
02:55:55,434 --> 02:55:56,802
RECOMMENDATIONS AS OPPOSED TO A 

4360
02:55:56,802 --> 02:55:59,238
GUIDELINE.

4361
02:55:59,238 --> 02:56:04,710
AND WE DO INTEND, WE PULLED OUT 

4362
02:56:04,710 --> 02:56:05,511
PHARMACOLOGIC INTERVENTIONS, 

4363
02:56:05,511 --> 02:56:10,349
RECOGNIZING THE RAPID EVIDENCE 

4364
02:56:10,349 --> 02:56:11,851
GENERATION WITHIN TLP-R1A AND 

4365
02:56:11,851 --> 02:56:13,486
DUAL THERAPY AND WE WILL BE 

4366
02:56:13,486 --> 02:56:17,823
LOOKING AT THAT IN THE FUTURE.

4367
02:56:17,823 --> 02:56:23,295
I WAS AMAZED AT DAVID 

4368
02:56:23,295 --> 02:56:25,564
ARTERBURN'S DAILY UPDATE FOR 

4369
02:56:25,564 --> 02:56:28,534
NEW PUBLICATIONS AT 10 PER DAY.

4370
02:56:28,534 --> 02:56:30,269
I FEEL FAIRLY DAUNTED IN TERMS 

4371
02:56:30,269 --> 02:56:31,971
OF TRYING TO DO THE EVIDENCE 

4372
02:56:31,971 --> 02:56:33,272
REVIEW OF THAT, BUT I CAN 

4373
02:56:33,272 --> 02:56:34,707
PROMISE YOU WE WILL BE DOING 

4374
02:56:34,707 --> 02:56:36,008
THAT IN THE FUTURE.

4375
02:56:36,008 --> 02:56:38,577
I DON'T HAVE A DATE FOR IT.

4376
02:56:38,577 --> 02:56:40,680
>> CHRISTINE WEE: HOW DO
YOU 

4377
02:56:40,680 --> 02:56:41,681
SEE REAL-WORLD EVIDENCE PLAYING 

4378
02:56:41,681 --> 02:56:42,214
A ROLE?

4379
02:56:42,214 --> 02:56:45,217
I THINK YOU FOCUSED A LOT ON 

4380
02:56:45,217 --> 02:56:46,018
RCT'S.

4381
02:56:46,018 --> 02:56:49,088
>> JOHN WONG: YOU KNOW, 

4382
02:56:49,088 --> 02:56:50,790
HISTORICALLY,WE HAVE FOCUSED ON 

4383
02:56:50,790 --> 02:56:52,358
REAL-WORLD EVIDENCE IN THE 

4384
02:56:52,358 --> 02:56:53,926
ABSENCE OF RCT DATA.

4385
02:56:53,926 --> 02:57:01,033
AND I'LL SAY THAT OUR EVIDENCE 

4386
02:57:01,033 --> 02:57:01,667
REVIEW PROCEDURES 

4387
02:57:01,667 --> 02:57:04,737
RECOMMENDATIONS SHOULD COME OUT 

4388
02:57:04,737 --> 02:57:07,206
OF THE ARHQ EFFECTIVE HEALTH 

4389
02:57:07,206 --> 02:57:08,874
PROGRAM AND SCIENTIFIC RESOURCE 

4390
02:57:08,874 --> 02:57:11,777
CENTER CAME UP WITH, RECOGNIZED 

4391
02:57:11,777 --> 02:57:14,914
THAT NRS OI,'S NON RANDOMIZED 

4392
02:57:14,914 --> 02:57:17,817
STUDIES OF INTERVENTIONS CAN 

4393
02:57:17,817 --> 02:57:19,719
PROVIDE COMPLIMENTARY DATA.

4394
02:57:19,719 --> 02:57:21,120
WHERE WE HAVE FOUNDATIONAL 

4395
02:57:21,120 --> 02:57:23,823
EVIDENCE, SUCH AS THE BENEFITS 

4396
02:57:23,823 --> 02:57:25,658
OF MAMMOGRAPHY, THOSE RCT'S 

4397
02:57:25,658 --> 02:57:28,127
WERE ALL DONE FROM THE 1970s UP 

4398
02:57:28,127 --> 02:57:31,030
TO THE 1990s, YET THINGS HAVE 

4399
02:57:31,030 --> 02:57:32,064
CHANGED SINCE THEN.

4400
02:57:32,064 --> 02:57:34,800
AND NONE OF THEM INCLUDED 

4401
02:57:34,800 --> 02:57:37,770
PATIENTS WHO WERE 75 AND OLDER.

4402
02:57:37,770 --> 02:57:40,005
AND CONSEQUENTLY, WE HAVE USED 

4403
02:57:40,005 --> 02:57:40,906
TRIAL EMULATION STUDIES TO TAKE 

4404
02:57:40,906 --> 02:57:43,476
A LOOK AT THAT AS WELL AS 

4405
02:57:43,476 --> 02:57:45,177
MODELING, JUST AS ONE EXAMPLE, 

4406
02:57:45,177 --> 02:57:46,846
AT LEAST FROM THE TASK FORCE 

4407
02:57:46,846 --> 02:57:49,315
STANDPOINT, AS WELL AS OUR 

4408
02:57:49,315 --> 02:57:50,349
EVIDENCE-REVIEW TEAMS, THEY ARE 

4409
02:57:50,349 --> 02:57:52,785
LOOKING AT OUTSIDE OF 

4410
02:57:52,785 --> 02:57:54,754
TRADITIONAL RANDOMIZED CONTROL 

4411
02:57:54,754 --> 02:57:56,589
TRIALS.

4412
02:57:56,589 --> 02:57:57,623
>> CHRISTINE WEE: WE HAVE 

4413
02:57:57,623 --> 02:57:59,091
ANOTHER QUESTION IN THE CHAT 

4414
02:57:59,091 --> 02:58:02,428
FROM ONE OF THE ORGANIZERS 

4415
02:58:02,428 --> 02:58:03,062
REGARDING GUIDELINES.

4416
02:58:03,062 --> 02:58:04,997
THE QUESTION IS DO WE NEED 

4417
02:58:04,997 --> 02:58:07,833
STUDIES TO BE COMPARING 

4418
02:58:07,833 --> 02:58:09,435
GLP-1'S, VERSUS LIFESTYLE 

4419
02:58:09,435 --> 02:58:11,070
INTERVENTIONS TO INFLUENCE 

4420
02:58:11,070 --> 02:58:12,705
GUIDELINES OR ARE WE AT THE 

4421
02:58:12,705 --> 02:58:15,407
STAGE WHERE THE STUDIES ARE 

4422
02:58:15,407 --> 02:58:17,643
MOST INTERESTED ARE REALLY 

4423
02:58:17,643 --> 02:58:20,346
COMPARING DIFFERENT 

4424
02:58:20,346 --> 02:58:22,248
PHARMACOLOGIC THERAPIES?

4425
02:58:22,248 --> 02:58:24,950
>> JOHN WONG: THAT'S A
FABULOUS 

4426
02:58:24,950 --> 02:58:26,819
QUESTION, FROM OUR TASK FORCE 

4427
02:58:26,819 --> 02:58:28,721
STANDPOINT, ANYTHING THAT WOULD 

4428
02:58:28,721 --> 02:58:30,623
IMPROVE HEALTH OUTCOMES IS WHAT 

4429
02:58:30,623 --> 02:58:33,359
WE FOCUS ON, IN TERMS OF 

4430
02:58:33,359 --> 02:58:35,194
BENEFITS AND HARMS.

4431
02:58:35,194 --> 02:58:37,263
OBVIOUSLY, CURRENTLY THERE ARE 

4432
02:58:37,263 --> 02:58:38,664
DIFFERENCES IN COSTS.

4433
02:58:38,664 --> 02:58:40,399
BUT AT LEAST FROM THE TASK 

4434
02:58:40,399 --> 02:58:41,667
FORCE PERSPECTIVE, WE DON'T 

4435
02:58:41,667 --> 02:58:42,701
THINK ABOUT THAT.

4436
02:58:42,701 --> 02:58:44,837
WE ARE STRICTLY FOCUSED ON WHAT 

4437
02:58:44,837 --> 02:58:46,071
WILL HELP PEOPLE.

4438
02:58:46,071 --> 02:58:53,512
AND SO, IN THAT SENSE, A 

4439
02:58:53,512 --> 02:58:55,447
COMPARISON OF INTERVENTIONS 

4440
02:58:55,447 --> 02:58:56,482
OTHER THAN PHARMACOLOGIC, I 

4441
02:58:56,482 --> 02:58:58,551
THINK WOULD BE HELPFUL FOR US 

4442
02:58:58,551 --> 02:59:00,686
TO UNDERSTAND THAT CHOICE FOR 

4443
02:59:00,686 --> 02:59:03,189
PATIENTS, AND WHETHER OR NOT 

4444
02:59:03,189 --> 02:59:06,292
ARE THERE FACTORS THAT MIGHT 

4445
02:59:06,292 --> 02:59:09,328
PREDISPOSE TO ONE OVER THE 

4446
02:59:09,328 --> 02:59:09,829
OTHER.

4447
02:59:09,829 --> 02:59:12,298
ARE THE BENEFITS COMPARABLE?

4448
02:59:12,298 --> 02:59:15,000
AND THIS QUESTION OF DURABILITY 

4449
02:59:15,000 --> 02:59:16,468
OF THE BENEFIT AND WHETHER OR 

4450
02:59:16,468 --> 02:59:20,005
NOT YOU COULD TRANSITION ONCE 

4451
02:59:20,005 --> 02:59:22,074
YOU HAVE LOST WEIGHT LOSS, OR 

4452
02:59:22,074 --> 02:59:24,376
WHETHER OR NOT THE INITIAL 

4453
02:59:24,376 --> 02:59:26,078
THERAPY IS WHAT'S REQUIRED AND 

4454
02:59:26,078 --> 02:59:27,346
HOW DURABLE IS IT.

4455
02:59:27,346 --> 02:59:29,181
BECAUSE MOST OF THESE STUDIES 

4456
02:59:29,181 --> 02:59:31,550
HAVE ONLY GONE OUT 12-18 MONTHS.

4457
02:59:31,550 --> 02:59:33,652
AND YOU AND I KNOW WEIGHT LOSS 

4458
02:59:33,652 --> 02:59:34,887
IS A DAILY SORT OF 

4459
02:59:34,887 --> 02:59:37,389
CONSIDERATION FOR OUR LIFESTYLE 

4460
02:59:37,389 --> 02:59:37,623
HABITS.

4461
02:59:37,623 --> 02:59:40,059
I THINK THOSE WILL BE IMPORTANT 

4462
02:59:40,059 --> 02:59:42,761
CONSIDERATIONS AS WELL AS THE 

4463
02:59:42,761 --> 02:59:43,429
POTENTIAL LIFE-LONG 

4464
02:59:43,429 --> 02:59:45,731
CONSEQUENCES THAT WE JUST ARE 

4465
02:59:45,731 --> 02:59:47,800
PROLONGED DURATION OF THESE 

4466
02:59:47,800 --> 02:59:50,302
MEDICATIONS THAT WERE 

4467
02:59:50,302 --> 02:59:51,570
ARTICULATED WELL EARLIER TODAY.

4468
02:59:51,570 --> 02:59:53,973
WE JUST DON'T KNOW YET.

4469
02:59:53,973 --> 02:59:55,774
>> CHRISTINE WEE: SO FINAL

4470
02:59:55,774 --> 02:59:59,245
QUESTION THAT I'M GOING TO ASK, 

4471
02:59:59,245 --> 03:00:03,649
DIRECTLY PRIMARILY TO ASHELEY 

4472
03:00:03,649 --> 03:00:07,786
BUT ALSO JOHN.

4473
03:00:07,786 --> 03:00:10,923
AS AN EDITOR I HAVE SEEN POORLY 

4474
03:00:10,923 --> 03:00:12,791
DESIGNED AND EXECUTED STUDIES 

4475
03:00:12,791 --> 03:00:18,998
THAT USE REAL-WORLD DATA AND 

4476
03:00:18,998 --> 03:00:22,301
OFTEN MISINTERPRETED OR UNDER 

4477
03:00:22,301 --> 03:00:24,236
INTERPRETED AND THEY GET 

4478
03:00:24,236 --> 03:00:26,205
PUBLISHED AND THE ASSUMPTIONS 

4479
03:00:26,205 --> 03:00:27,473
ARE INCORRECT, BASED ON THE 

4480
03:00:27,473 --> 03:00:29,775
QUALITY OF THE STUDY DESIGN.

4481
03:00:29,775 --> 03:00:32,544
WE KNOW THAT SYSTEMATIC REVIEWS 

4482
03:00:32,544 --> 03:00:36,515
THAT COMPILE, THIS IS LARGELY 

4483
03:00:36,515 --> 03:00:38,317
REAL-WORLD EVIDENCE WILL PULL 

4484
03:00:38,317 --> 03:00:40,119
RESULTS FROM HIGH AND POOR 

4485
03:00:40,119 --> 03:00:41,220
QUALITY DATA.

4486
03:00:41,220 --> 03:00:42,688
BASED ON YOUR EXPERIENCE, I 

4487
03:00:42,688 --> 03:00:44,323
DIRECT IT TO DR. SKINNER, 

4488
03:00:44,323 --> 03:00:46,859
BECAUSE I ASSUME YOU RELY MORE 

4489
03:00:46,859 --> 03:00:47,660
ON REAL-WORLD EVIDENCE BECAUSE 

4490
03:00:47,660 --> 03:00:50,996
OF LACK OF RCT DATA, HOW DO 

4491
03:00:50,996 --> 03:00:54,066
GUIDELINE COMMITTEES SORT OF 

4492
03:00:54,066 --> 03:00:55,768
NAVIGATE WEIGHING, GOING 

4493
03:00:55,768 --> 03:00:57,636
THROUGH THE LITERATURE, THE 

4494
03:00:57,636 --> 03:00:58,804
QUITE VAST LITERATURE ON THE 

4495
03:00:58,804 --> 03:01:01,373
TOPIC?

4496
03:01:01,373 --> 03:01:03,842
>> DR. SKINNER: YES, QUITE
VAST 

4497
03:01:03,842 --> 03:01:07,179
IS AN UNDER STATEMENT.

4498
03:01:07,179 --> 03:01:10,316
SO IN OUR, IN THE CPG FOR 

4499
03:01:10,316 --> 03:01:12,785
CHILDREN AND ADOLESCENCE, WE 

4500
03:01:12,785 --> 03:01:15,054
ACTUALLY DID NOT INCLUDE 

4501
03:01:15,054 --> 03:01:16,088
SYSTEMATIC REVIEWS IN THAT.

4502
03:01:16,088 --> 03:01:17,990
THAT'S ONE OF THE WAYS WE 

4503
03:01:17,990 --> 03:01:19,858
APPROACH THAT, THAT WAY WE CAN 

4504
03:01:19,858 --> 03:01:22,127
ENSURE THAT THE EVIDENCE THAT 

4505
03:01:22,127 --> 03:01:24,663
WE ARE USING THAT WE GRADE EACH 

4506
03:01:24,663 --> 03:01:27,599
OF THOSE STUDIES BASED ON THEIR 

4507
03:01:27,599 --> 03:01:28,801
RISK OF BIAS.

4508
03:01:28,801 --> 03:01:30,336
AND THAT WAY WE KNOW WE ARE 

4509
03:01:30,336 --> 03:01:31,370
DOING THAT WITH THE ORIGINAL 

4510
03:01:31,370 --> 03:01:32,171
STUDY.

4511
03:01:32,171 --> 03:01:34,640
SO THAT'S ONE OF THE APPROACHES 

4512
03:01:34,640 --> 03:01:37,743
WE HAVE USED.

4513
03:01:37,743 --> 03:01:40,479
I THINK THAT IT'S PART OF A 

4514
03:01:40,479 --> 03:01:41,747
CONVERSATION THAT HAPPENS WITH 

4515
03:01:41,747 --> 03:01:43,816
WE ARE SITTING AROUND THE TABLE 

4516
03:01:43,816 --> 03:01:45,050
ABOUT WHAT RECOMMENDATIONS WE 

4517
03:01:45,050 --> 03:01:47,619
ARE GOING TO MAKE.

4518
03:01:47,619 --> 03:01:50,022
IT'S OFTEN NOT AN EXACT BLACK 

4519
03:01:50,022 --> 03:01:51,490
OR WHITE SCIENCE HERE OF WHAT 

4520
03:01:51,490 --> 03:01:52,758
YOU DO WITH THAT.

4521
03:01:52,758 --> 03:01:55,060
BUT YOU KNOW, I THINK 

4522
03:01:55,060 --> 03:01:56,128
DEFINITELY IDENTIFYING THOSE 

4523
03:01:56,128 --> 03:01:58,831
STUDIES THAT ARE NOT DOING A 

4524
03:01:58,831 --> 03:02:01,166
VERY GOOD JOB, OR PARTICULARLY 

4525
03:02:01,166 --> 03:02:03,068
IN MOST CONCERNING THOSE THAT 

4526
03:02:03,068 --> 03:02:07,406
ARE OVER INTERPRETING THE 

4527
03:02:07,406 --> 03:02:08,474
EFFECTIVENESS OR LACK OF HARM 

4528
03:02:08,474 --> 03:02:11,176
OR SOMETHING OF THAT NATURE.

4529
03:02:11,176 --> 03:02:12,811
>> CHRISTINE WEE: JOHN, DO
YOU 

4530
03:02:12,811 --> 03:02:15,047
WANT TO ADD ANYTHING TO THAT?

4531
03:02:15,047 --> 03:02:20,452
>> JOHN WONG: YOU KNOW, WE
HAVE 

4532
03:02:20,452 --> 03:02:22,321
EXPERTS IN THE CENTERS.

4533
03:02:22,321 --> 03:02:23,789
THEY LOOK AT THREE SOURCES FOR 

4534
03:02:23,789 --> 03:02:27,326
THE QUALITY OF EVIDENCE, IN 

4535
03:02:27,326 --> 03:02:32,097
TERMS OF THEIR CLINICAL 

4536
03:02:32,097 --> 03:02:32,865
APPROPRIATENESS FOR COMBINING 

4537
03:02:32,865 --> 03:02:33,766
ANALYSIS.

4538
03:02:33,766 --> 03:02:36,068
ALWAYS DO A SYSTEMATIC REVIEW.

4539
03:02:36,068 --> 03:02:39,872
THE QUESTION IS SHOULD YOU DO A 

4540
03:02:39,872 --> 03:02:41,173
QUANTITATIVE SYNTHESIS OR NOT.

4541
03:02:41,173 --> 03:02:46,111
THEY THINK OF CLINICAL HETERO 

4542
03:02:46,111 --> 03:02:47,613
GENESTITY, INCLUSION OR 

4543
03:02:47,613 --> 03:02:49,281
EXCLUSION, OUTCOMES, THE TYPES 

4544
03:02:49,281 --> 03:02:51,417
OF PARTICIPANTS, THE FOLLOW-UP 

4545
03:02:51,417 --> 03:02:54,753
TIME, THE OUTCOMES THEY ARE 

4546
03:02:54,753 --> 03:02:55,354
CONSIDERING.

4547
03:02:55,354 --> 03:02:58,390
THEY THINK OF METH DO LOGIC 

4548
03:02:58,390 --> 03:02:59,058
ISSUES.

4549
03:02:59,058 --> 03:03:00,492
THEY THINK A LITTLE BIT 

4550
03:03:00,492 --> 03:03:06,098
OBVIOUSLY ABOUT STATISTICAL 

4551
03:03:06,098 --> 03:03:07,366
HETEROGENEITY AND WHETHER IT'S 

4552
03:03:07,366 --> 03:03:09,034
APPROPRIATE TO INCLUDE AND THEY 

4553
03:03:09,034 --> 03:03:10,769
HAVE AN ALGORITHM THEY WORK 

4554
03:03:10,769 --> 03:03:11,537
THROUGH.

4555
03:03:11,537 --> 03:03:15,074
SO FROM A QUALITY STANDPOINT, 

4556
03:03:15,074 --> 03:03:16,742
AND THEN THE TASK FORCE ITSELF 

4557
03:03:16,742 --> 03:03:22,681
THINKS OF APPLICABILITY, 

4558
03:03:22,681 --> 03:03:24,750
FEASIBILITY IT THEY ARE DONE IN 

4559
03:03:24,750 --> 03:03:26,085
OTHER COUNTRIES IS IT 

4560
03:03:26,085 --> 03:03:27,286
TRANSPORTABLE TO UNITED STATES.

4561
03:03:27,286 --> 03:03:28,987
THOSE ARE ALL THINGS THAT GO 

4562
03:03:28,987 --> 03:03:30,756
INTO OUR RECOMMENDATION 

4563
03:03:30,756 --> 03:03:38,664
STATEMENTS.

4564
03:03:38,664 --> 03:03:43,402
I AGREE WITH YOU, THERE'S HIGH 

4565
03:03:43,402 --> 03:03:45,370
HETEROGENEITY AND WHETHER OR 

4566
03:03:45,370 --> 03:03:48,107
NOT TO POOL DEPENDS ON THE 

4567
03:03:48,107 --> 03:03:48,907
STRENGTHS AND LIMITATIONS WE 

4568
03:03:48,907 --> 03:03:50,609
HEARD ABOUT THIS MORNING.

4569
03:03:50,609 --> 03:03:52,444
>> CHRISTINE WEE: I THINK
THE 

4570
03:03:52,444 --> 03:03:54,079
REAL CHALLENGE WITH 

4571
03:03:54,079 --> 03:03:55,547
OBSERVATIONAL STUDIES AS 

4572
03:03:55,547 --> 03:03:57,216
OPPOSED TO RCT'S IS REALLY 

4573
03:03:57,216 --> 03:04:01,820
IDENTIFYING WHAT I WOULD SAY 

4574
03:04:01,820 --> 03:04:02,221
FATAL LIMITATIONS.

4575
03:04:02,221 --> 03:04:04,123
LIKE CONFOUNDING.

4576
03:04:04,123 --> 03:04:05,991
WHICH OFTEN, THE METHODOLOGIST 

4577
03:04:05,991 --> 03:04:08,927
WHO MAY NOT BE CONTENT EXPERTS 

4578
03:04:08,927 --> 03:04:10,762
MAY NOT EASILY BE ABLE TO 

4579
03:04:10,762 --> 03:04:12,831
IDENTIFY.

4580
03:04:12,831 --> 03:04:14,266
I'M REASSURED, DR. SKINNER, THE 

4581
03:04:14,266 --> 03:04:15,868
TASK FORCE, OR YOUR COMMIT HE 

4582
03:04:15,868 --> 03:04:18,103
IS DOING THAT REVIEW YOURSELF.

4583
03:04:18,103 --> 03:04:19,138
WE HAVE TWO MINUTES.

4584
03:04:19,138 --> 03:04:20,806
I THINK I WILL ASK THE LAST 

4585
03:04:20,806 --> 03:04:22,908
QUESTION IN THE CHAT, WHICH IS 

4586
03:04:22,908 --> 03:04:24,910
DIRECTED TO DR. SKINNER.

4587
03:04:24,910 --> 03:04:26,812
HOW DO YOU APPROACH 

4588
03:04:26,812 --> 03:04:29,081
CONVERSATIONS ABOUT GLP-1'S 

4589
03:04:29,081 --> 03:04:30,749
WITH PEDIATRIC PATIENTS AND 

4590
03:04:30,749 --> 03:04:32,217
THEIR PARENTS GIVEN CURRENT 

4591
03:04:32,217 --> 03:04:33,652
LIMITATIONS WITH THE EVIDENCE?

4592
03:04:33,652 --> 03:04:35,721
>> WELL I'M NOT A
CLINICIAN, SO 

4593
03:04:35,721 --> 03:04:38,757
I DON'T HAVE TO APPROACH THESE 

4594
03:04:38,757 --> 03:04:39,091
CONVERSATIONS.

4595
03:04:39,091 --> 03:04:40,092
BUT OBVIOUSLY WORK VERY CLOSELY 

4596
03:04:40,092 --> 03:04:44,463
WITH THOSE WHO DO.

4597
03:04:44,463 --> 03:04:47,599
IN GENERAL, I THINK THEY ARE 

4598
03:04:47,599 --> 03:04:48,867
VERY HONEST ABOUT THE EVIDENCE 

4599
03:04:48,867 --> 03:04:52,337
WE DO HAVE, WHAT WE DON'T KNOW.

4600
03:04:52,337 --> 03:04:56,074
MOST OF THE CHILDREN I HAVE 

4601
03:04:56,074 --> 03:04:58,177
EXPOSURE TO THROUGH THE 

4602
03:04:58,177 --> 03:05:00,879
CLINICIANS ARE IN AN OBESITY 

4603
03:05:00,879 --> 03:05:06,185
TREATMENT PROGRAM SO THEY ARE 

4604
03:05:06,185 --> 03:05:08,420
OFTEN SIGNIFICANT, SEVERE 

4605
03:05:08,420 --> 03:05:10,522
OBESITY WITH COMORBIDITIES SO 

4606
03:05:10,522 --> 03:05:11,757
THAT CHANGES WHAT THOSE 

4607
03:05:11,757 --> 03:05:12,491
DISCUSSIONS LOOK LIKE.

4608
03:05:12,491 --> 03:05:14,293
I THINK THAT'S THE BEST WE CAN 

4609
03:05:14,293 --> 03:05:15,961
DO WITH ANY PATIENT OR ANYBODY.

4610
03:05:15,961 --> 03:05:17,529
HERE IS WHAT WE KNOW AND WHAT 

4611
03:05:17,529 --> 03:05:19,531
WE DON'T KNOW.

4612
03:05:19,531 --> 03:05:21,333
SUPPORT THEM IN MAKING 

4613
03:05:21,333 --> 03:05:21,833
DECISIONS.

4614
03:05:21,833 --> 03:05:24,536
I THINK WE CERTAINLY COULD USE 

4615
03:05:24,536 --> 03:05:25,837
BETTER INFORMATION ABOUT HOW TO 

4616
03:05:25,837 --> 03:05:36,381
HELP THEM MAKE THOSE DECISIONS.

4617
03:05:37,749 --> 03:05:38,750
>> CHRISTINE WEE: THANK
YOU 

4618
03:05:38,750 --> 03:05:39,518
VERY MUCH.

4619
03:05:39,518 --> 03:05:41,787
THIS IS SUCH A GREAT DISCUSSION 

4620
03:05:41,787 --> 03:05:45,524
AND YOUR THREE DISCUSSIONS WERE 

4621
03:05:45,524 --> 03:05:46,358
VERY ENLIGHTENING.

4622
03:05:46,358 --> 03:05:48,327
I GUESS WE WILL BREAK NOW FOR 

4623
03:05:48,327 --> 03:05:48,527
LUNCH.

4624
03:05:48,527 --> 03:05:50,762
>> Craig Hales: THAT'S
RIGHT, 

4625
03:05:50,762 --> 03:05:52,664
THANKS.

4626
03:05:52,664 --> 03:05:54,566
>> CHRISTINE WEE: MAYBE
REMIND 

4627
03:05:54,566 --> 03:05:56,235
EVERYBODY WHEN WE ARE SUPPOSED 

4628
03:05:56,235 --> 03:05:56,969
TO TUNE BACK IN.

4629
03:05:56,969 --> 03:05:58,704
>> Craig Hales: SURE, WE
WILL 

4630
03:05:58,704 --> 03:06:01,840
BREAK FOR LUNCH AND START AGAIN
AT 1:10 P.M. EASTERN TIME.

4631
03:06:01,840 --> 03:06:04,120
THANK YOU.

4632
03:06:04,543 --> 03:06:06,011


4633
03:06:06,011 --> 03:06:06,278


4634
03:06:06,278 --> 03:06:05,311
>> Craig Hales: THANK YOU.

4635
03:06:05,311 --> 03:06:06,746
>> I WANT TO GO OVER

4636
03:06:06,746 --> 03:06:07,813
HOUSEKEEPING RULES BEFORE THE

4637
03:06:07,813 --> 03:06:10,082
NEXT SESSION, THE MEETING IS

4638
03:06:10,082 --> 03:06:13,486
BEING RECORDED, POSTED TO THE

4639
03:06:13,486 --> 03:06:15,688
NIH WEBSITE.

4640
03:06:15,688 --> 03:06:16,188
DANIELLE FROM SCIENTIFIC

4641
03:06:16,188 --> 03:06:20,760
CONSULTING GROUP IS THE MEETING

4642
03:06:20,760 --> 03:06:21,527
HOST.

4643
03:06:21,527 --> 03:06:24,263
E-MAIL HER WITH ANY TECHNICAL

4644
03:06:24,263 --> 03:06:24,497
ISSUES.

4645
03:06:24,497 --> 03:06:27,199
USE THE Q&A FUNCTION TO
ENTER

4646
03:06:27,199 --> 03:06:28,301
QUESTIONS FOR THE SPEAKERS AT

4647
03:06:28,301 --> 03:06:30,503
ANY TIME DURING THE

4648
03:06:30,503 --> 03:06:32,338
PRESENTATIONS OR MODERATED

4649
03:06:32,338 --> 03:06:32,638
DISCUSSION.

4650
03:06:32,638 --> 03:06:35,641
ATTENDEES CAN UPVOTE QUESTIONS

4651
03:06:35,641 --> 03:06:38,577
IN THE Q&A, ANSWERED
DISCUSSION

4652
03:06:38,577 --> 03:06:40,446
FOR EACH SESSION.

4653
03:06:40,446 --> 03:06:44,817
THE CHAT IS DISABLED AND THE

4654
03:06:44,817 --> 03:06:45,918
"RAISE HAND" FEATURE WILL NOT BE

4655
03:06:45,918 --> 03:06:46,352
USED.

4656
03:06:46,352 --> 03:06:50,323
USE THE Q&A FUNCTION
INSTEAD.

4657
03:06:50,323 --> 03:06:53,259
NOW I'D LIKE TO WELCOME DR.

4658
03:06:53,259 --> 03:06:54,393
DAVENE WRIGHT, MODERATOR FOR

4659
03:06:54,393 --> 03:06:55,961
SESSION 2-RBGS REAL WORLD

4660
03:06:55,961 --> 03:06:58,664
EVIDENCE FOR PUBLIC AND PRIVATE

4661
03:06:58,664 --> 03:07:01,767
PAYER COVERAGE DECISIONS.

4662
03:07:01,767 --> 03:07:02,702
DR. WRIGHT?

4663
03:07:02,702 --> 03:07:05,438
>> THING YOU FOR JOINING
US.

4664
03:07:05,438 --> 03:07:06,339
I'M DAVENE WRIGHT, ASSOCIATE

4665
03:07:06,339 --> 03:07:09,375
PROFESSOR AT  HARVARD MEDICAL

4666
03:07:09,375 --> 03:07:10,443
SCHOOL, PLEASED TO MODERATE THIS

4667
03:07:10,443 --> 03:07:12,278
SESSION ON THE REAL WORLD

4668
03:07:12,278 --> 03:07:14,413
EVIDENCE FOR PUBLIC AND PRIVATE

4669
03:07:14,413 --> 03:07:16,582
PAYER COVERAGE DECISIONS, EACH

4670
03:07:16,582 --> 03:07:18,651
OF OUR THREE SPEAKERS WILL SPEAK

4671
03:07:18,651 --> 03:07:20,019
FOR 20 MINUTES, FOLLOWED BY

4672
03:07:20,019 --> 03:07:21,620
30-MINUTE MODERATED DISCUSSION

4673
03:07:21,620 --> 03:07:24,123
WITH ALL SPEAKERS.

4674
03:07:24,123 --> 03:07:25,024
PLEASE POST AND UPVOTE QUESTIONS

4675
03:07:25,024 --> 03:07:28,094
IN THE Q&A BOX ON TEAMS,

4676
03:07:28,094 --> 03:07:30,096
INDICATE WHICH SPEAKER YOUR

4677
03:07:30,096 --> 03:07:32,665
QUESTION IS FOR.

4678
03:07:32,665 --> 03:07:36,502
FIRST UP DR. ANAND PAREKH, CHIEF

4679
03:07:36,502 --> 03:07:39,271
MEDICAL ADVISER OF THE

4680
03:07:39,271 --> 03:07:40,573
BIPARTISAN POLICY CENTER, A

4681
03:07:40,573 --> 03:07:42,775
BOARD CERTIFIED INTERNAL

4682
03:07:42,775 --> 03:07:44,076
MEDICINE PHYSICIAN, INCOMING

4683
03:07:44,076 --> 03:07:45,845
CHAIR OF ROUNDTABLE ON OBESITY

4684
03:07:45,845 --> 03:07:48,581
SOLUTIONS NATIONAL ACADEMIES OF

4685
03:07:48,581 --> 03:07:49,982
SCIENCES, ENGINEERING, AND

4686
03:07:49,982 --> 03:07:52,585
MEDICINE, FORMERLY AN HHS DEPUTY

4687
03:07:52,585 --> 03:07:54,220
ASSISTANT SECRETARY FOR HEALTH,

4688
03:07:54,220 --> 03:07:55,321
DEVELOPED AND IMPLEMENTED

4689
03:07:55,321 --> 03:07:56,522
NATIONAL INITIATIVES ON

4690
03:07:56,522 --> 03:07:58,491
PREVENTION AND CARE MANAGEMENT,

4691
03:07:58,491 --> 03:07:59,959
DR. PAREKH WILL PROVIDE A

4692
03:07:59,959 --> 03:08:02,228
NATIONAL AND PUBLIC PAYER

4693
03:08:02,228 --> 03:08:05,631
PERSPECTIVE ON COVERAGE OF GLP-1

4694
03:08:05,631 --> 03:08:07,633
THERAPIES.

4695
03:08:07,633 --> 03:08:09,935
TAKE IT AWAY.

4696
03:08:09,935 --> 03:08:11,771
>> THANK YOU FOR THE

4697
03:08:11,771 --> 03:08:13,839
INTRODUCTION, TO CRAIG, AND

4698
03:08:13,839 --> 03:08:17,109
NIDDK FOR THIS WORKSHOP.

4699
03:08:17,109 --> 03:08:26,752
I'LL SHARE MY SCREEN HERE AND

4700
03:08:26,752 --> 03:08:26,986
SLIDES.

4701
03:08:26,986 --> 03:08:28,854
LET'S SEE.

4702
03:08:28,854 --> 03:08:29,622
ALL RIGHT.

4703
03:08:29,622 --> 03:08:33,325
CAN FOLKS SEE THE SLIDES?

4704
03:08:33,325 --> 03:08:34,393
>>  YES, THEY LOOK GOOD

4705
03:08:34,393 --> 03:08:35,528
>> GREAT.

4706
03:08:35,528 --> 03:08:35,961
WONDERFUL.

4707
03:08:35,961 --> 03:08:38,264
JUST A LITTLE BIT OF DISCLOSURES

4708
03:08:38,264 --> 03:08:40,766
AT THE OUTSET, THE BIPARTISAN

4709
03:08:40,766 --> 03:08:41,867
POLICY CENTER, WE'RE A THINK

4710
03:08:41,867 --> 03:08:43,068
TANK IN WASHINGTON, D.C. THAT

4711
03:08:43,068 --> 03:08:44,603
TRIES TO TAKE THE BEST IDEAS

4712
03:08:44,603 --> 03:08:46,672
FROM BOTH SIDES TO PROMOTE

4713
03:08:46,672 --> 03:08:47,573
HEALTH SECURITY AND OPPORTUNITY,

4714
03:08:47,573 --> 03:08:49,542
WE WORK ON VARIETY OF HEALTH

4715
03:08:49,542 --> 03:08:53,045
POLICY ISSUES AS WE THINK OF

4716
03:08:53,045 --> 03:08:54,013
THREE-LEGGED STOOL, ISSUES THAT,

4717
03:08:54,013 --> 03:08:57,316
ONE, WE THINK ARE IMPORTANT

4718
03:08:57,316 --> 03:08:59,251
HEALTH POLICY ISSUES; TWO, BOTH

4719
03:08:59,251 --> 03:09:01,587
SIDES NEED TO BE EDUCATED;

4720
03:09:01,587 --> 03:09:03,956
THREE, THERE'S A POLICY WINDOW.

4721
03:09:03,956 --> 03:09:06,058
SO AT THE FEDERAL LEVEL CONGRESS

4722
03:09:06,058 --> 03:09:08,260
OR EXECUTIVE BRANCH CARES ABOUT

4723
03:09:08,260 --> 03:09:09,161
THIS.

4724
03:09:09,161 --> 03:09:12,064
WHEN WE TALK ABOUT OBESITY, 40%

4725
03:09:12,064 --> 03:09:14,700
OF ADULTS, 100 MILLION

4726
03:09:14,700 --> 03:09:17,870
AMERICANS, CHILDREN AS WELL, AND

4727
03:09:17,870 --> 03:09:19,171
GLP-1-BASED THERAPIES, A

4728
03:09:19,171 --> 03:09:21,774
CRITICAL POLICY ISSUE SO IT'S

4729
03:09:21,774 --> 03:09:24,410
BEEN A SPACE WE'VE ACTIVELY BEEN

4730
03:09:24,410 --> 03:09:24,643
ON.

4731
03:09:24,643 --> 03:09:28,581
IN 2022, WE DID PUBLISH A

4732
03:09:28,581 --> 03:09:29,682
REPORT, TITLED EXPANDING ACCESS

4733
03:09:29,682 --> 03:09:31,650
TO OBESITY TREATMENTS IN OLDER

4734
03:09:31,650 --> 03:09:38,524
ADULTS, AND WHAT WE DID IS

4735
03:09:38,524 --> 03:09:42,561
ESSENTIALLY CONDUCT A SYSTEMATIC

4736
03:09:42,561 --> 03:09:44,029
REVIEW OF 21 RANDOMIZED

4737
03:09:44,029 --> 03:09:44,864
CONTROLLED TRIALS EVALUATING

4738
03:09:44,864 --> 03:09:47,066
WEIGHT LOSS INTERVENTION OF ONE

4739
03:09:47,066 --> 03:09:49,368
YEAR IN DURATION NOT CURRENTLY

4740
03:09:49,368 --> 03:09:52,438
COVERED BY MEDICARE, SO A NUMBER

4741
03:09:52,438 --> 03:09:56,075
OF FDA-APPROVED PHARMACEUTICALS

4742
03:09:56,075 --> 03:10:06,585
INCLUDING TWO GLP-1s, GLUTIDE

4743
03:10:08,420 --> 03:10:10,155
AND SEMI GLUTIDE, AND THE

4744
03:10:10,155 --> 03:10:13,993
CONCLUSION, BACK IN 2022 GIVE

4745
03:10:13,993 --> 03:10:15,294
THAN OBESITY IS RECOGNIZED AS

4746
03:10:15,294 --> 03:10:17,196
CHRONIC DISEASE, THERE ARE

4747
03:10:17,196 --> 03:10:19,932
FDA-APPROVED MEDICATIONS FOR

4748
03:10:19,932 --> 03:10:21,667
OBESITY, THAT POLICYMAKERS

4749
03:10:21,667 --> 03:10:23,202
SHOULD REMOVE STATUTORY

4750
03:10:23,202 --> 03:10:26,071
PROHIBITION ON MEDICARE PARK D

4751
03:10:26,071 --> 03:10:27,106
COVERAGE FOR FDA-APPROVED

4752
03:10:27,106 --> 03:10:27,740
ANTI-OBESITY MEDICATIONS.

4753
03:10:27,740 --> 03:10:29,275
WE'LL DISCUSS THAT IN A MOMENT.

4754
03:10:29,275 --> 03:10:32,678
WE CONCLUDED FURTHER STUDIES IN

4755
03:10:32,678 --> 03:10:34,446
THE OLDER ADULT POPULATION

4756
03:10:34,446 --> 03:10:37,816
HELPED IN CONSIDERATION FOR

4757
03:10:37,816 --> 03:10:42,288
TREATMENTS AND SUBSEQUENTLY OUR

4758
03:10:42,288 --> 03:10:42,988
SISTER ORGANIZATION, BPC ACTION,

4759
03:10:42,988 --> 03:10:46,592
DID ENDORSE AND WE'LL TALK ABOUT

4760
03:10:46,592 --> 03:10:50,195
THIS THIS BILL IN CONGRESS TO

4761
03:10:50,195 --> 03:10:52,264
TREAT AND REDUCE OBESITY THAT

4762
03:10:52,264 --> 03:10:54,033
WOULD ALLOW FOR MEDICARE

4763
03:10:54,033 --> 03:10:55,367
COVERAGE OF THESE MEDICATIONS,

4764
03:10:55,367 --> 03:10:58,137
SO JUST A COUPLE DISCLOSURES AS

4765
03:10:58,137 --> 03:10:59,271
WE START ABOUT THE ORGANIZATION

4766
03:10:59,271 --> 03:11:09,114
AS WELL AS OUR WORK.

4767
03:11:09,114 --> 03:11:16,488
I WANT TO COVER MEDICARE IF HE

4768
03:11:16,488 --> 03:11:20,459
-- █AT THE FEDERAL LEVEL, WHAT

4769
03:11:20,459 --> 03:11:23,262
DOES DoD DO, AND COVER

4770
03:11:23,262 --> 03:11:25,464
MEDICAID, AND HONE IN ON WHERE I

4771
03:11:25,464 --> 03:11:28,534
THINK WE NEED SOME MORE REAL

4772
03:11:28,534 --> 03:11:29,201
WORLD EVIDENCE.

4773
03:11:29,201 --> 03:11:31,904
SO, LET'S START WITH MEDICARE.

4774
03:11:31,904 --> 03:11:34,707
MEDICARE CURRENTLY DOES COVER

4775
03:11:34,707 --> 03:11:39,211
GLP-1 DRUGS FOR TYPE 2 DIABETES.

4776
03:11:39,211 --> 03:11:41,380
IT ALSO COVERS GLP-1 DRUGS FOR

4777
03:11:41,380 --> 03:11:43,649
SLEEP APNEA WITH OBESITY, SO

4778
03:11:43,649 --> 03:11:49,455
MODERATE TO SEVERE SLEEP APNEA

4779
03:11:49,455 --> 03:11:52,391
WITH OBESITY AND COVERS GLP-1

4780
03:11:52,391 --> 03:11:55,894
FOR CARDIOVASCULAR DISEASE WITH

4781
03:11:55,894 --> 03:11:57,229
OBESITY, SPECIFICALLY REDUCE THE

4782
03:11:57,229 --> 03:12:00,966
RISK OF MAJOR CARDIAC EVENTS IN

4783
03:12:00,966 --> 03:12:01,433
NON-DIABETIC ADULT WAS

4784
03:12:01,433 --> 03:12:02,067
ESTABLISHED CARDIOVASCULAR

4785
03:12:02,067 --> 03:12:04,336
DISEASE AND YOU HAVE TO BE

4786
03:12:04,336 --> 03:12:06,005
OVERWEIGHT OR OBESE.

4787
03:12:06,005 --> 03:12:09,074
SO IN SELECT CASES, WITH

4788
03:12:09,074 --> 03:12:10,576
OBESITY, MEDICARE CURRENTLY

4789
03:12:10,576 --> 03:12:12,911
COVERS THESE DRUGS.

4790
03:12:12,911 --> 03:12:14,413
BUT OVERALL, MEDICARE CURRENTLY

4791
03:12:14,413 --> 03:12:19,218
DOES NOT COVER ANY ANTI-OBESITY

4792
03:12:19,218 --> 03:12:20,986
MEDICATION FOR OBESITY, OBESITY

4793
03:12:20,986 --> 03:12:24,056
ALONE, DUE TO STATUTORY

4794
03:12:24,056 --> 03:12:25,357
PROHIBITION OF COSMETIC WEIGHS

4795
03:12:25,357 --> 03:12:27,292
LOT DRUGS THAT PREDATES

4796
03:12:27,292 --> 03:12:29,395
ENACTMENT OF MEDICARE PART D IN

4797
03:12:29,395 --> 03:12:31,664
2003 AND SO ESSENTIALLY THE

4798
03:12:31,664 --> 03:12:33,465
SOCIAL SECURITY ACT ALLOWS

4799
03:12:33,465 --> 03:12:35,968
EXCLUSION OF, QUOTE, ANY AGENT

4800
03:12:35,968 --> 03:12:37,803
WHEN USED FOR ANOREXIA, WEIGHT

4801
03:12:37,803 --> 03:12:40,439
LOSS, OR WEIGHT GAIN, AND FOR

4802
03:12:40,439 --> 03:12:42,975
THE LAST TWO DECADES, UP TILL

4803
03:12:42,975 --> 03:12:44,276
LAST NOVEMBER, CMS INTERPRETED

4804
03:12:44,276 --> 03:12:47,346
THAT FOR MEDICARE AS ESSENTIALLY

4805
03:12:47,346 --> 03:12:50,983
PRECLUDING THE COVERAGE OF

4806
03:12:50,983 --> 03:12:51,517
ANTI-OBESITY MEDICATIONS,

4807
03:12:51,517 --> 03:12:52,217
INCLUDING GLP-1s.

4808
03:12:52,217 --> 03:12:53,919
THERE WAS LEGISLATION.

4809
03:12:53,919 --> 03:12:55,554
THERE HAS BEEN OVER THE LAST

4810
03:12:55,554 --> 03:12:57,089
SEVERAL YEARS IN CONGRESS,

4811
03:12:57,089 --> 03:12:58,390
BIPARTISAN LEGISLATION, WITH

4812
03:12:58,390 --> 03:13:01,360
HUNDREDS OF SPONSORS, DEMOCRAT

4813
03:13:01,360 --> 03:13:02,628
AND REPUBLICAN, CALLED TREAT AND

4814
03:13:02,628 --> 03:13:06,665
REDUCE OBESITY ACT I WOULD WHICH

4815
03:13:06,665 --> 03:13:07,933
WOULD ALLOW COVERAGE AGAIN FOR

4816
03:13:07,933 --> 03:13:11,570
THE TREATMENT OF OBESITY OR FOR

4817
03:13:11,570 --> 03:13:12,905
WEIGHT LOSS MANAGEMENT FOR

4818
03:13:12,905 --> 03:13:13,639
INDIVIDUALS OVERWEIGHT.

4819
03:13:13,639 --> 03:13:17,509
ESSENTIALLY COVERAGE OF ANY

4820
03:13:17,509 --> 03:13:20,045
FDA-APPROVED MEDICATION FOR

4821
03:13:20,045 --> 03:13:20,412
OBESITY.

4822
03:13:20,412 --> 03:13:22,347
THIS BILL HAS NOT MOVED

4823
03:13:22,347 --> 03:13:24,049
SIGNIFICANTLY IN ITS OWN RIGHT,

4824
03:13:24,049 --> 03:13:25,818
MODIFIED VERSION OF THIS BILL

4825
03:13:25,818 --> 03:13:27,686
ACTUALLY DID MOVE LAST YEAR IN

4826
03:13:27,686 --> 03:13:32,925
THE HOUSE WAYS AND MEANS

4827
03:13:32,925 --> 03:13:34,560
COMMITTEE, PASSED AN AMENDED

4828
03:13:34,560 --> 03:13:36,095
VERSION THAT WOULD SORT OF BREAK

4829
03:13:36,095 --> 03:13:39,832
THIS DOWN OR CUT THIS DOWN TO

4830
03:13:39,832 --> 03:13:43,635
THE EXTENT THAT ONLY INDIVIDUALS

4831
03:13:43,635 --> 03:13:45,537
STARTING ON MEDICARE PREVIOUSLY

4832
03:13:45,537 --> 03:13:46,638
ON GLP-1s OR ANTI-OBESITY

4833
03:13:46,638 --> 03:13:48,874
MEDICATION FOR A YEAR PRIOR TO

4834
03:13:48,874 --> 03:13:50,542
STARTING ON MEDICARE WOULD BE

4835
03:13:50,542 --> 03:13:50,909
COVERED.

4836
03:13:50,909 --> 03:13:56,648
SO OBVIOUSLY A MUCH SMALLER SIZE

4837
03:13:56,648 --> 03:13:57,783
OF THE MEDICARE POPULATION, YOU

4838
03:13:57,783 --> 03:14:02,988
KNOW, THAT RAISES EQUITY AND

4839
03:14:02,988 --> 03:14:04,556
OTHER CONCERNS BUT THIS IS A

4840
03:14:04,556 --> 03:14:05,657
BILL CURRENTLY STILL IN

4841
03:14:05,657 --> 03:14:09,561
CONGRESS, HAS NOT BEEN PASSED BY

4842
03:14:09,561 --> 03:14:10,095
CONGRESS.

4843
03:14:10,095 --> 03:14:12,231
AND ONE OF THE CHIEF REASONS WHY

4844
03:14:12,231 --> 03:14:16,068
EVEN THOUGH WE'RE STILL ACCRUING

4845
03:14:16,068 --> 03:14:18,270
EVIDENCE ON THE BENEFITS,

4846
03:14:18,270 --> 03:14:19,271
LONG-TERM BENEFITS OF GLP-1s,

4847
03:14:19,271 --> 03:14:22,207
ONE OF THE MAIN REASONS WHY IT

4848
03:14:22,207 --> 03:14:25,911
HASN'T MOVED IS BECAUSE OF THE

4849
03:14:25,911 --> 03:14:28,013
FISCAL IMPACT TO THE FEDERAL

4850
03:14:28,013 --> 03:14:28,881
BUDGET.

4851
03:14:28,881 --> 03:14:30,816
AND YOU'LL HEAR ABOUT THIS MORE

4852
03:14:30,816 --> 03:14:33,986
IN A FEW MINUTES FROM NOELIA BUT

4853
03:14:33,986 --> 03:14:35,320
LAST OCTOBER THE CONGRESSIONAL

4854
03:14:35,320 --> 03:14:38,257
BUDGET OFFICE RELEASED ON REPORT

4855
03:14:38,257 --> 03:14:40,392
ON HYPOTHETICALLY IF YOU DID

4856
03:14:40,392 --> 03:14:41,994
EXPAND COVERAGE OF ANTI-OBESITY

4857
03:14:41,994 --> 03:14:43,662
MEDICATIONS IN THE MEDICARE

4858
03:14:43,662 --> 03:14:45,697
PROGRAM WHAT WOULD BE THE

4859
03:14:45,697 --> 03:14:47,633
POTENTIAL FISCAL IMPACT AND

4860
03:14:47,633 --> 03:14:50,769
CONCLUSION AS YOU'LL HEAR FROM

4861
03:14:50,769 --> 03:14:53,138
THAT REPORT WAS LOOKING AT A

4862
03:14:53,138 --> 03:14:55,274
VARIETY OF -- MAKING A VARIETY

4863
03:14:55,274 --> 03:14:56,575
OF ASSUMPTIONS ON CRITICAL

4864
03:14:56,575 --> 03:14:59,611
FACTORS, NET INCREASE IN FEDERAL

4865
03:14:59,611 --> 03:15:02,881
SPENDING BY ABOUT $35 BILLION

4866
03:15:02,881 --> 03:15:04,783
OVER NINE YEARS WITH ASSUMPTIONS

4867
03:15:04,783 --> 03:15:07,286
SUCH AS UPTAKE RATES INCREASING

4868
03:15:07,286 --> 03:15:10,889
FROM 2% TO 14% OVER THAT TIME

4869
03:15:10,889 --> 03:15:11,356
PERIOD.

4870
03:15:11,356 --> 03:15:13,859
SO OBVIOUSLY WHATEVER YOU MAKE

4871
03:15:13,859 --> 03:15:18,764
OF THESE ASSUMPTION THAT CAN

4872
03:15:18,764 --> 03:15:21,033
THEN CHANGE THE ULTIMATE FEDERAL

4873
03:15:21,033 --> 03:15:21,934
ESTIMATED SPENDING AMOUNT, THAT

4874
03:15:21,934 --> 03:15:26,438
WAS THE REPORT IN OCTOBER.

4875
03:15:26,438 --> 03:15:27,940
VERY SHORTLY THEREAFTER IN

4876
03:15:27,940 --> 03:15:31,677
NOVEMBER, CMS FOR THE FIRST TIME

4877
03:15:31,677 --> 03:15:32,778
PROPOSED REINTERPRETING THAT

4878
03:15:32,778 --> 03:15:33,912
LONGTIME EXCLUSION THAT READING

4879
03:15:33,912 --> 03:15:35,981
OF THE SOCIAL SECURITY ACT THAT

4880
03:15:35,981 --> 03:15:38,016
I MENTIONED BUT GIVEN THAT

4881
03:15:38,016 --> 03:15:40,986
OBESITY IS NOW RECOGNIZED AS A

4882
03:15:40,986 --> 03:15:43,055
DISEASE, CMS PROPOSED PART D

4883
03:15:43,055 --> 03:15:44,690
COVERAGE OF ANTI-OBESITY

4884
03:15:44,690 --> 03:15:46,158
MEDICATIONS FOR INDIVIDUALS,

4885
03:15:46,158 --> 03:15:50,062
BENEFICIARIES WITH OBESITY, NOT

4886
03:15:50,062 --> 03:15:53,031
OVERWEIGHT BUT JUST OBESITY, AND

4887
03:15:53,031 --> 03:15:54,833
ALSO PROPOSED APPLYING THAT TO

4888
03:15:54,833 --> 03:15:56,802
THE MEDICAID PROGRAM.

4889
03:15:56,802 --> 03:15:57,870
AND WE'LL GET TO THE MEDICAID

4890
03:15:57,870 --> 03:16:01,607
PROGRAM IN A  SECOND BUT IT'S

4891
03:16:01,607 --> 03:16:04,576
ALWAYS BEEN OPTION FOR MEDICAID

4892
03:16:04,576 --> 03:16:05,577
PROGRAM, THAT REINTERPRETATION

4893
03:16:05,577 --> 03:16:10,782
WAS IN A PROPOSED RULE THAT

4894
03:16:10,782 --> 03:16:16,989
CMS'S ESTIMATES WERE IT WOULD

4895
03:16:16,989 --> 03:16:18,824
INCREASE COSTS BY $15 BILLION

4896
03:16:18,824 --> 03:16:22,060
DUE TO EXPANDED MEDICAID

4897
03:16:22,060 --> 03:16:23,262
COVERAGE, ESTIMATED UPTAKE

4898
03:16:23,262 --> 03:16:24,463
3.4 MILLION MEDICAL CARE AND 4

4899
03:16:24,463 --> 03:16:27,065
MILLION MEDICAID BENEFICIARIES.

4900
03:16:27,065 --> 03:16:28,767
THERE WERE ABOUT 25,000 COMMENTS

4901
03:16:28,767 --> 03:16:31,503
THAT CAME IN TO CMS OVER SEVERAL

4902
03:16:31,503 --> 03:16:33,839
MONTHS, ULTIMATELY DURING THE

4903
03:16:33,839 --> 03:16:35,107
NEW ADMINISTRATION, CURRENT

4904
03:16:35,107 --> 03:16:36,308
TRUMP ADMINISTRATION, IT WAS

4905
03:16:36,308 --> 03:16:38,143
DECIDED JUST EARLIER THIS MONTH

4906
03:16:38,143 --> 03:16:39,912
THAT PROPOSAL WAS NOT INCLUDED

4907
03:16:39,912 --> 03:16:42,381
IN THE FINAL RULE SO IT WILL NOT

4908
03:16:42,381 --> 03:16:51,423
BE MOVING FORWARD AT THIS TIME.

4909
03:16:51,423 --> 03:16:53,392
MOST PEOPLE KNOW MEDICARE NOW

4910
03:16:53,392 --> 03:16:55,260
HAS ABILITY TO NEGOTIATE

4911
03:16:55,260 --> 03:16:57,763
PRESCRIPTION DRUG PRICES, AND

4912
03:16:57,763 --> 03:17:01,066
THE FIRST LIST OF 10 DRUGS THAT

4913
03:17:01,066 --> 03:17:03,402
OCCURRED IN THE LAST YEAR, THE

4914
03:17:03,402 --> 03:17:12,477
NEXT SET OF DRUGS DOES INCLUDE

4915
03:17:12,477 --> 03:17:15,547
SEMAGLUTIDE, SO MEDICARE WILL

4916
03:17:15,547 --> 03:17:20,085
NEGOTIATE WITH THE INCLUSION

4917
03:17:20,085 --> 03:17:23,322
WITH A TWO-YEAR LAG PERIOD.

4918
03:17:23,322 --> 03:17:25,857
THAT'S ON THE MEDICARE SIDE.

4919
03:17:25,857 --> 03:17:30,429
THAT'S GREAT, THAT'S FOR THE 60

4920
03:17:30,429 --> 03:17:32,731
MILLION MEDICARE BENEFICIARIES

4921
03:17:32,731 --> 03:17:34,800
BUT WHAT ABOUT OTHER AMERICANS

4922
03:17:34,800 --> 03:17:36,134
ON FEDERAL GOVERNMENT INSURANCE

4923
03:17:36,134 --> 03:17:36,702
PROGRAMS?

4924
03:17:36,702 --> 03:17:40,105
THINK ABOUT THE MILITARY AND

4925
03:17:40,105 --> 03:17:46,511
DEPARTMENT OF DEFENSE AND

4926
03:17:46,511 --> 03:17:49,915
TRICARE, COVERAGE OF GLP-1s

4927
03:17:49,915 --> 03:17:51,216
FOR DIABETES

4928
03:17:51,216 --> 03:17:53,352
AND FOR WEIGHT MANAGEMENT PRIOR

4929
03:17:53,352 --> 03:17:54,853
AUTHORIZE AS, MEET BIM CRITERIA,

4930
03:17:54,853 --> 03:17:57,189
UNDERGO SIX MONTHS OF BEHAVIORAL

4931
03:17:57,189 --> 03:17:57,923
MODIFICATION AND DIETARY

4932
03:17:57,923 --> 03:18:01,660
RESTRICTION AS WELL AS THREE

4933
03:18:01,660 --> 03:18:03,328
MONTHS OF USING OTHER

4934
03:18:03,328 --> 03:18:05,731
ANTI-OBESITY MEDICATIONS SO

4935
03:18:05,731 --> 03:18:07,899
GENERIC ALTERNATIVE MEDICATIONS,

4936
03:18:07,899 --> 03:18:11,603
ANNUAL OWN THEN ARE YOU -- IS IT

4937
03:18:11,603 --> 03:18:13,572
COVERED, ARE GLP-1s COVERED

4938
03:18:13,572 --> 03:18:16,308
FOR WEIGHT MANAGEMENT, SIMILARLY

4939
03:18:16,308 --> 03:18:18,076
THE VETERANS DEPARTMENT COVERS

4940
03:18:18,076 --> 03:18:20,379
GLP-1s FOR TYPE 2 DIABETES FOR

4941
03:18:20,379 --> 03:18:21,279
FOR WEIGHT MANAGEMENT AND

4942
03:18:21,279 --> 03:18:24,016
OBESITY YOU NEED TO PASS THROUGH

4943
03:18:24,016 --> 03:18:25,650
SIGNIFICANT PRIOR AUTHORIZATION,

4944
03:18:25,650 --> 03:18:28,286
BMI, PARTICIPATION IN

4945
03:18:28,286 --> 03:18:29,054
COMPREHENSIVE LIFESTYLE

4946
03:18:29,054 --> 03:18:32,190
INTERVENTION PROGRAM AND EITHER

4947
03:18:32,190 --> 03:18:33,191
FAILURE OF GENERIC ALTERNATIVES,

4948
03:18:33,191 --> 03:18:36,595
AND THAT MEANS NOT MEETING AT

4949
03:18:36,595 --> 03:18:38,597
LEAST 5% REDUCTION IN BODY

4950
03:18:38,597 --> 03:18:39,998
WEIGHT, WHICH CLINICALLY IS

4951
03:18:39,998 --> 03:18:43,835
ASSOCIATED WITH ALL THOSE

4952
03:18:43,835 --> 03:18:44,703
PARAMETERS THAT WE CARE ABOUT

4953
03:18:44,703 --> 03:18:48,240
WEIGHT AND BLOOD PRESSURE AND

4954
03:18:48,240 --> 03:18:49,441
CHOLESTEROL, AS WELL AS OTHERS.

4955
03:18:49,441 --> 03:18:52,377
AND THEN THE OFFICE OF PERSONNEL

4956
03:18:52,377 --> 03:18:54,346
MANAGEMENT REQUIRES, IF YOU'RE A

4957
03:18:54,346 --> 03:18:55,213
FEDERAL GOVERNMENT EMPLOYEE,

4958
03:18:55,213 --> 03:18:57,849
EVERY CARRIER TO COVER AT LEAST

4959
03:18:57,849 --> 03:19:03,021
ONE GLP-1 DRUG FOR WEIGHT LOSS

4960
03:19:03,021 --> 03:19:03,555
SINCE EARLY 2023.

4961
03:19:03,555 --> 03:19:06,825
AND SO I THINK FROM A BIGGER

4962
03:19:06,825 --> 03:19:07,692
PICTURE PERSPECTIVE WHAT I HOPE

4963
03:19:07,692 --> 03:19:09,561
YOU START TO APPRECIATE IS EVEN

4964
03:19:09,561 --> 03:19:12,564
THOUGH WE HAVE SORT OF ONE

4965
03:19:12,564 --> 03:19:13,532
FEDERAL GOVERNMENT, AND

4966
03:19:13,532 --> 03:19:14,733
DEPENDING ON THE INSURANCE

4967
03:19:14,733 --> 03:19:17,069
PROGRAM THAT YOU'RE ON, WHETHER

4968
03:19:17,069 --> 03:19:21,339
IT'S MEDICARE, WHETHER IT'S A

4969
03:19:21,339 --> 03:19:22,340
FEDERAL EMPLOYEE HEALTH BENEFIT

4970
03:19:22,340 --> 03:19:24,743
PROGRAM OR DoD, HOW THE

4971
03:19:24,743 --> 03:19:27,279
GOVERNMENT APPROACHES COVERAGE

4972
03:19:27,279 --> 03:19:31,683
OF GLP-1s FOR OBESITY AND

4973
03:19:31,683 --> 03:19:32,217
WEIGHT MANAGEMENT DIFFERS

4974
03:19:32,217 --> 03:19:35,153
DEPENDING ON THE PROGRAM.

4975
03:19:35,153 --> 03:19:37,055
MEDICAID IS A FEDERAL/STATE

4976
03:19:37,055 --> 03:19:41,293
PROGRAM AND PARTNERSHIP,

4977
03:19:41,293 --> 03:19:43,261
STATUTORY DEFINITION IS FOR

4978
03:19:43,261 --> 03:19:43,829
OBESITY MEDICATIONS, QUOTE,

4979
03:19:43,829 --> 03:19:45,697
AGENTS WHEN USED FOR ANOREXIA,

4980
03:19:45,697 --> 03:19:47,332
WEIGHT LOSS, OR WEIGHT GAIN MAY

4981
03:19:47,332 --> 03:19:49,401
BE EXCLUDED.

4982
03:19:49,401 --> 03:19:51,603
SO HERE MEDICAID AND STATES GET

4983
03:19:51,603 --> 03:19:54,439
THE CHOICE OF PARTICULARLY FOR

4984
03:19:54,439 --> 03:19:57,008
ADULTS, 40% OF MEDICAID

4985
03:19:57,008 --> 03:19:58,176
BENEFICIARIES HAVE OBESITY,

4986
03:19:58,176 --> 03:19:59,778
STATES HAVE THE PREROGATIVE TO

4987
03:19:59,778 --> 03:20:03,215
DECIDE WHETHER THEY WANT TO

4988
03:20:03,215 --> 03:20:04,883
COVER ANTI-OBESITY MEDICATIONS

4989
03:20:04,883 --> 03:20:07,686
AND GLP-1s, TECHNICALLY FOR

4990
03:20:07,686 --> 03:20:08,687
KIDS, ALL ANTI-OBESITY

4991
03:20:08,687 --> 03:20:11,189
MEDICATIONS SHOULD BE COVERED

4992
03:20:11,189 --> 03:20:15,460
UNDER WHAT'S CALLED EPSDT

4993
03:20:15,460 --> 03:20:16,428
BENEFITS, EARLY PERIODIC

4994
03:20:16,428 --> 03:20:17,796
SCREENING DIAGNOSTIC AND

4995
03:20:17,796 --> 03:20:20,298
TREATMENT PROGRAM, BUT WHEN YOU

4996
03:20:20,298 --> 03:20:23,034
DIG UNDERNEATH AND TRY TO FIND

4997
03:20:23,034 --> 03:20:25,437
THE DETAILS, VERY FEW ACTUALLY

4998
03:20:25,437 --> 03:20:27,539
DO COVER THE SECOND WAY THEY ARE

4999
03:20:27,539 --> 03:20:30,142
SUPPOSED TO DO IT BUT FOR ADULTS

5000
03:20:30,142 --> 03:20:34,079
WE'RE AT 13 OR 14 STATES

5001
03:20:34,079 --> 03:20:35,180
NATIONALLY THAT ARE COVERING

5002
03:20:35,180 --> 03:20:36,081
THESE DRUGS.

5003
03:20:36,081 --> 03:20:38,383
WHEN I SAY COVERING, THEY COME

5004
03:20:38,383 --> 03:20:41,119
IN ALL SORT OF SIZES AND SHAPES,

5005
03:20:41,119 --> 03:20:43,155
JUST LIKE WE TALKED ABOUT, V.A.

5006
03:20:43,155 --> 03:20:46,324
AND DoD, MANY OF THESE STATES

5007
03:20:46,324 --> 03:20:47,259
HAVE SIGNIFICANT PRIOR

5008
03:20:47,259 --> 03:20:52,397
AUTHORIZATIONS, WE'LL GIVE A

5009
03:20:52,397 --> 03:20:53,899
COUPLE EXAMPLES LIKE

5010
03:20:53,899 --> 03:20:56,001
MISSISSIPPI, INITIAL IS BASED ON

5011
03:20:56,001 --> 03:20:57,102
BMI AND COMORBID CONDITIONS BUT

5012
03:20:57,102 --> 03:20:58,970
EVERY SIX MONTHS HAS TO BE

5013
03:20:58,970 --> 03:21:00,071
REAUTHORIZATION BASED ON

5014
03:21:00,071 --> 03:21:03,808
PROGRESS TOWARDS OVERCOMING

5015
03:21:03,808 --> 03:21:04,276
OBESITY.

5016
03:21:04,276 --> 03:21:05,377
IN VIRGINIA, AUTHORIZATION

5017
03:21:05,377 --> 03:21:08,146
INCLUDES YOU HAVE TO BE IN A

5018
03:21:08,146 --> 03:21:10,215
COMPREHENSIVE LIFESTYLE

5019
03:21:10,215 --> 03:21:11,449
INTERVENTION, PROVIDERS HAVE TO

5020
03:21:11,449 --> 03:21:12,951
ATTEST THAT THE PATIENCE'S

5021
03:21:12,951 --> 03:21:14,386
OBESITY IS DISABLING AND

5022
03:21:14,386 --> 03:21:15,253
LIFE-THREATENING.

5023
03:21:15,253 --> 03:21:17,422
PATIENTS HAVE TO TRY A NON-GLP-1

5024
03:21:17,422 --> 03:21:19,191
AGONIST FOR WEIGHT LOSS IN THE

5025
03:21:19,191 --> 03:21:25,797
PREVIOUS SIX MONTHS, AND NOT BE

5026
03:21:25,797 --> 03:21:31,269
PROGRESSING, SO SIGNIFICANT

5027
03:21:31,269 --> 03:21:32,037
PRIOR AUTHORIZATION, MICHIGAN,

5028
03:21:32,037 --> 03:21:36,508
YOU HAVE TO FAIL LOSING 5% OF

5029
03:21:36,508 --> 03:21:37,676
BASELINE WEIGHT, GO THROUGH A

5030
03:21:37,676 --> 03:21:40,445
NUMBER OF HOOPS BUT AT LEAST 13

5031
03:21:40,445 --> 03:21:44,583
TO 14 MEDICAID PROGRAMS IN SOME

5032
03:21:44,583 --> 03:21:47,285
CAPACITY ARE COVERING GLP-1s.

5033
03:21:47,285 --> 03:21:50,855
AND STATE EMPLOYEE HEALTH PLANS,

5034
03:21:50,855 --> 03:21:52,591
I'M FOCUSING ON FEDERAL BUT

5035
03:21:52,591 --> 03:21:54,459
PUBLIC SIDE FOR STATES THERE ARE

5036
03:21:54,459 --> 03:21:57,829
WILL 16 STATE EMPLOYEE HEALTH

5037
03:21:57,829 --> 03:22:00,332
PLANS THAT ARE COVERING

5038
03:22:00,332 --> 03:22:01,333
GLP-1s, A COUPLE NOTABLE ONES

5039
03:22:01,333 --> 03:22:06,638
RECENTLY IN THE NEWS WHO

5040
03:22:06,638 --> 03:22:07,706
REVERSED, THEY SAW ASTRONOMICAL

5041
03:22:07,706 --> 03:22:11,343
INCREASES IN COST AND REVERSED.

5042
03:22:11,343 --> 03:22:12,210
COLORADO, WEST VIRGINIA COME TO

5043
03:22:12,210 --> 03:22:15,280
MIND, NORTH CAROLINA COMES TO

5044
03:22:15,280 --> 03:22:17,115
MIND AS WELL.

5045
03:22:17,115 --> 03:22:19,618
SO WEIGHING BENEFITS VERSUS COST

5046
03:22:19,618 --> 03:22:21,152
IS VERY DIFFICULT DECISION FOR

5047
03:22:21,152 --> 03:22:23,388
REALLY ALL 50 STATES, BOTH FOR

5048
03:22:23,388 --> 03:22:29,060
MEDICAID PROGRAMS AS WELL AS

5049
03:22:29,060 --> 03:22:30,929
STATE EMPLOYEE HEALTH PLANS.

5050
03:22:30,929 --> 03:22:34,866
BACK TO MEDICAID, KAISER DID AN

5051
03:22:34,866 --> 03:22:36,401
IMPORTANT RECENT SURVEY ASKING

5052
03:22:36,401 --> 03:22:37,402
FOR THOSE WHO ARE COVERING IT

5053
03:22:37,402 --> 03:22:38,970
WHY ARE YOU COVERING IT?

5054
03:22:38,970 --> 03:22:40,438
YOU SEE SOME OF THE MAIN REASONS

5055
03:22:40,438 --> 03:22:42,173
ON THE RIGHT THERE.

5056
03:22:42,173 --> 03:22:44,576
FOR THOSE NOT COVERING IT, WHAT

5057
03:22:44,576 --> 03:22:46,144
ARE THE REASONS YOU'RE NOT

5058
03:22:46,144 --> 03:22:48,980
COVERING IT?

5059
03:22:48,980 --> 03:22:51,016
NO SURPRISE THAT COST REALLY

5060
03:22:51,016 --> 03:22:52,250
TWO-THIRDS OF STATES NOTED COST

5061
03:22:52,250 --> 03:22:56,521
AS THE NUMBER ONE BARRIER FOR

5062
03:22:56,521 --> 03:22:59,791
NOT COVERING OBESITY MEDICATION.

5063
03:22:59,791 --> 03:23:02,961
OTHER REASONS WERE POTENTIAL

5064
03:23:02,961 --> 03:23:03,795
SIDE EFFECTS, ADHERENCE

5065
03:23:03,795 --> 03:23:04,896
CONCERNS, NEED FOR LEGISLATIVE

5066
03:23:04,896 --> 03:23:06,798
ACTION, A NUMBER OF REASONS BUT

5067
03:23:06,798 --> 03:23:09,768
COST IS I WOULD SAY THE BIG

5068
03:23:09,768 --> 03:23:10,101
ISSUE.

5069
03:23:10,101 --> 03:23:13,071
I WANT TO SPEND A COUPLE MINUTES

5070
03:23:13,071 --> 03:23:15,674
ON A REALLY THINK NICE WHITE

5071
03:23:15,674 --> 03:23:17,108
PAPER THAT CAME OUT FROM THE

5072
03:23:17,108 --> 03:23:19,744
INSTITUTE FOR CLINICAL AND

5073
03:23:19,744 --> 03:23:21,179
ECONOMIC REVIEW IN THE LAST FEW

5074
03:23:21,179 --> 03:23:21,579
WEEKS.

5075
03:23:21,579 --> 03:23:25,383
AGAIN, WITH THE WHOLE GOAL BEING

5076
03:23:25,383 --> 03:23:27,619
WE KNOW ABOUT THE PROMISE AND

5077
03:23:27,619 --> 03:23:29,054
BENEFITS THAT WE'RE STILL

5078
03:23:29,054 --> 03:23:30,055
LEARNING ABOUT LONG-TERM

5079
03:23:30,055 --> 03:23:33,725
BENEFITS OF GLP-1s, BUT HOW DO

5080
03:23:33,725 --> 03:23:34,726
WE ENSURE AFFORDABLE AND

5081
03:23:34,726 --> 03:23:38,129
EQUITABLE ACCESS FOR NEW OBESITY

5082
03:23:38,129 --> 03:23:39,064
MEDICATIONS, AND WHAT KAISER DID

5083
03:23:39,064 --> 03:23:41,399
WAS LIFT OUR WHAT ARE SOME OF

5084
03:23:41,399 --> 03:23:43,134
THE MARKET STRATEGIES BEING

5085
03:23:43,134 --> 03:23:45,270
UTILIZED RIGHT NOW OR COULD BE

5086
03:23:45,270 --> 03:23:48,440
UTILIZED, WHAT ARE SOME FEDERAL

5087
03:23:48,440 --> 03:23:50,508
ACTIONS BEING CONTEMPLATED RIGHT

5088
03:23:50,508 --> 03:23:52,344
NOW, OR COULD BE IMPLEMENTED IN

5089
03:23:52,344 --> 03:23:55,113
THE FUTURE, AGAIN, TO ENSURE

5090
03:23:55,113 --> 03:23:56,448
AFFORDABLE AND EQUITABLE ACCESS,

5091
03:23:56,448 --> 03:23:58,316
YOU KNOW, A COUPLE ONES HERE

5092
03:23:58,316 --> 03:24:04,522
JUST TO LIST OFF, ON THE MARKET

5093
03:24:04,522 --> 03:24:05,857
STRATEGY SIDE WHAT CAN

5094
03:24:05,857 --> 03:24:07,459
PURCHASERS DO, THEY CAN

5095
03:24:07,459 --> 03:24:09,027
TEMPORARILY DENY COVERAGE AND

5096
03:24:09,027 --> 03:24:11,796
SAY WE NEED MORE REAL WORLD

5097
03:24:11,796 --> 03:24:12,430
EVIDENCE OF THAT PERSISTENCE.

5098
03:24:12,430 --> 03:24:14,299
WE NEED TO WAIT FOR COSTS TO

5099
03:24:14,299 --> 03:24:16,768
COME DOWN THROUGH MARKET

5100
03:24:16,768 --> 03:24:18,436
COMPETITION OR NEGOTIATION.

5101
03:24:18,436 --> 03:24:20,939
LET'S HOLD OFF.

5102
03:24:20,939 --> 03:24:23,141
ANOTHER STRATEGY IS TO IDENTIFY

5103
03:24:23,141 --> 03:24:25,076
ARE THERE SOME SUBPOPULATIONS OR

5104
03:24:25,076 --> 03:24:27,846
ARE THERE SOME WAYS WHERE WE CAN

5105
03:24:27,846 --> 03:24:29,381
ALLOW THE POPULATION HEALTH

5106
03:24:29,381 --> 03:24:31,049
BENEFIT FROM GLP-1s TO START

5107
03:24:31,049 --> 03:24:34,619
TO BE REALIZED THROUGH ENHANCED

5108
03:24:34,619 --> 03:24:35,453
PRIOR AUTHORIZATION, SO THERE

5109
03:24:35,453 --> 03:24:38,556
ARE A LOT OF INTERESTING IDEAS

5110
03:24:38,556 --> 03:24:40,425
HERE FROM NARROWING COVERAGE

5111
03:24:40,425 --> 03:24:42,293
THROUGH BMI AND CLINICAL

5112
03:24:42,293 --> 03:24:43,695
COMORBIDITY RESTRICTION, WE NEED

5113
03:24:43,695 --> 03:24:46,798
SOME REAL WORLD EVIDENCE FOR

5114
03:24:46,798 --> 03:24:47,098
THAT.

5115
03:24:47,098 --> 03:24:49,167
DO YOU REQUIRE LIFESTYLE

5116
03:24:49,167 --> 03:24:49,734
MANAGEMENT AS PRE-RECOLLECT

5117
03:24:49,734 --> 03:24:56,441
WHICH  PREREQUISITE OR

5118
03:24:56,441 --> 03:24:59,077
CONCOMITANT, SHOULD WE LIMIT

5119
03:24:59,077 --> 03:25:00,712
DURATION OF TREATMENT, THROUGH

5120
03:25:00,712 --> 03:25:02,347
ANECDOTAL EXPERIENCE IN ENGLAND

5121
03:25:02,347 --> 03:25:04,315
AND CLAIMS BY COMPANIES THAT

5122
03:25:04,315 --> 03:25:06,184
SUGGEST SOME PATIENTS CAN

5123
03:25:06,184 --> 03:25:10,121
MAINTAIN WEIGHT LOSS AFTER

5124
03:25:10,121 --> 03:25:11,790
DISCONTINUATION OF GLP-1s, DO

5125
03:25:11,790 --> 03:25:13,958
WE NEED REAL WORLD EVIDENCE

5126
03:25:13,958 --> 03:25:14,392
THERE?

5127
03:25:14,392 --> 03:25:17,996
SHOULD THERE THERE BE STEP

5128
03:25:17,996 --> 03:25:19,230
THERAPY, THERE'S SOME EVIDENCE

5129
03:25:19,230 --> 03:25:20,331
THIS SUGGESTS SOME PATIENTS

5130
03:25:20,331 --> 03:25:22,834
DON'T NEED GLP-1s YOU ABOUT

5131
03:25:22,834 --> 03:25:24,602
COULD MEET WEIGHT TARGETS WITH

5132
03:25:24,602 --> 03:25:26,237
LESS EXPENSIVE MEDICATIONS AND

5133
03:25:26,237 --> 03:25:27,772
COULD YOU STRUCTURE A BENEFIT

5134
03:25:27,772 --> 03:25:30,642
SUBSET, YOU ONLY GET TO GLP-1s

5135
03:25:30,642 --> 03:25:34,145
AS WE'VE SEEN A LOT OF STATES, I

5136
03:25:34,145 --> 03:25:36,548
JUST MENTIONED V.A. AND DoD

5137
03:25:36,548 --> 03:25:38,950
DOING, ONLY IF YOU'RE NOT ABLE

5138
03:25:38,950 --> 03:25:41,686
TO LOSE OR MEET WEIGHT TARGETS

5139
03:25:41,686 --> 03:25:42,921
WITH LESS EXPENSIVE MEDICATION.

5140
03:25:42,921 --> 03:25:46,691
SO A NUMBER OF WAYS YOU COULD

5141
03:25:46,691 --> 03:25:48,827
USE PRIOR AUTHORIZATION AND

5142
03:25:48,827 --> 03:25:50,562
FORMULARY MANAGEMENT, PROVIDER

5143
03:25:50,562 --> 03:25:52,630
NETWORK MANAGEMENT, YOU ALLOW A

5144
03:25:52,630 --> 03:25:56,601
BROADER ARRAY OF PROVIDERS,

5145
03:25:56,601 --> 03:25:59,137
PRIMARY CARE PROVIDERS, TO

5146
03:25:59,137 --> 03:26:00,972
PRESCRIBE GLP-1s BUT WITH

5147
03:26:00,972 --> 03:26:03,274
TIGHT UTILIZATION VERSUS DO YOU

5148
03:26:03,274 --> 03:26:05,777
JUST ALLOW OBESITY SPECIALISTS

5149
03:26:05,777 --> 03:26:08,746
AND NARROW PANEL TO PRESCRIBE

5150
03:26:08,746 --> 03:26:14,519
THESE MEDICATIONS WITHOUT

5151
03:26:14,519 --> 03:26:15,153
UTILIZATION MANAGEMENT,

5152
03:26:15,153 --> 03:26:16,221
DIFFERENT MARKET STRATEGIES OUT

5153
03:26:16,221 --> 03:26:17,755
THERE CURRENTLY BEING THOUGHT

5154
03:26:17,755 --> 03:26:18,890
OF.

5155
03:26:18,890 --> 03:26:20,358
ON THE FEDERAL ACTION SIDE,

5156
03:26:20,358 --> 03:26:22,427
CERTAINLY A NUMBER OF THINGS

5157
03:26:22,427 --> 03:26:24,529
BEING DISCUSSED FROM EXPANDING

5158
03:26:24,529 --> 03:26:27,465
MEDICARE COVERAGE, WE SAW CMS

5159
03:26:27,465 --> 03:26:29,000
DECIDED NOT TO CURRENTLY MOVE

5160
03:26:29,000 --> 03:26:30,735
FORWARD WITH THE PROPOSED RULE

5161
03:26:30,735 --> 03:26:33,505
TO EXPAND COVERAGE, COULD THEY

5162
03:26:33,505 --> 03:26:34,239
REVISIT THAT RULE?

5163
03:26:34,239 --> 03:26:38,076
COULD THERE BE A NEW CENTER FOR

5164
03:26:38,076 --> 03:26:39,844
MEDICARE AND MEDICAID INNOVATION

5165
03:26:39,844 --> 03:26:43,114
MODEL THAT TESTS EXPANSION OF

5166
03:26:43,114 --> 03:26:43,648
GLP-1s?

5167
03:26:43,648 --> 03:26:45,416
COULD ACCESS BE MANDATED THROUGH

5168
03:26:45,416 --> 03:26:46,317
U.S. PREVENTIVE SERVICE TASK

5169
03:26:46,317 --> 03:26:48,887
FORCE, WHICH AS YOU KNOW IS AN

5170
03:26:48,887 --> 03:26:50,455
INDEPENDENT BODY THAT RATES

5171
03:26:50,455 --> 03:26:51,923
CLINICAL PREVENTIVE SERVICES,

5172
03:26:51,923 --> 03:26:54,492
THOSE RATED A AND B THROUGH THE

5173
03:26:54,492 --> 03:26:56,127
AFFORDABLE CARE ACT MUST BE

5174
03:26:56,127 --> 03:26:58,029
COVERED, IN MOST CASES, BY

5175
03:26:58,029 --> 03:27:00,198
PRIVATE INSURERS WITHOUT COST

5176
03:27:00,198 --> 03:27:01,733
SHARING.

5177
03:27:01,733 --> 03:27:02,834
COULD GLP-1s AND ANTI-OBESITY

5178
03:27:02,834 --> 03:27:04,202
MEDICATIONS BE CONSIDERED

5179
03:27:04,202 --> 03:27:05,603
THROUGH THAT, PROBABLY NOT

5180
03:27:05,603 --> 03:27:07,605
LIKELY EVEN THOUGH THERE ARE --

5181
03:27:07,605 --> 03:27:09,807
THERE WAS PRECEDENT FOR THAT AS

5182
03:27:09,807 --> 03:27:11,776
WELL, HIV MEDICATION, BUT MORE

5183
03:27:11,776 --> 03:27:13,478
FOR PRIMARY PREVENTION AS

5184
03:27:13,478 --> 03:27:14,312
OPPOSED TO TREATMENT.

5185
03:27:14,312 --> 03:27:16,981
SHOULD THERE BE MORE AGGRESSIVE

5186
03:27:16,981 --> 03:27:21,853
NEGOTIATION OF PRICES, WE TALKED

5187
03:27:21,853 --> 03:27:23,488
ABOUT SEMAGLUTIDE FOR 2027, AND

5188
03:27:23,488 --> 03:27:25,256
SOME OTHER OPTIONS THAT I THINK

5189
03:27:25,256 --> 03:27:27,992
ARE PROBABLY LESS REALISTIC BUT

5190
03:27:27,992 --> 03:27:31,396
PROVIDING FEDERAL SUBSIDIES TO

5191
03:27:31,396 --> 03:27:33,264
COMMERCIAL INSURERS, LICENSING

5192
03:27:33,264 --> 03:27:36,568
TO GENERIC MANUFACTURERS, SO

5193
03:27:36,568 --> 03:27:42,273
THERE'S MORE -- IT'S MORE

5194
03:27:42,273 --> 03:27:43,575
AFFORDABLE FOR PUBLIC PLAYERS,

5195
03:27:43,575 --> 03:27:45,443
ALL HAVE PROS AND CONS BUT A

5196
03:27:45,443 --> 03:27:48,079
HELPFUL FRAMEWORK TO START

5197
03:27:48,079 --> 03:27:54,852
THINKING ABOUT COVERAGE OF

5198
03:27:54,852 --> 03:27:55,753
GLP-1s.

5199
03:27:55,753 --> 03:27:57,722
I WANTS TO END ON GAPS AND

5200
03:27:57,722 --> 03:27:58,323
OPPORTUNITIES.

5201
03:27:58,323 --> 03:27:59,557
THE BIGGEST TWO OPPORTUNITIES,

5202
03:27:59,557 --> 03:28:02,193
THE FIRST IS FOR MICROSIMULATION

5203
03:28:02,193 --> 03:28:03,661
RESEARCH, THE SECOND IS REAL

5204
03:28:03,661 --> 03:28:04,829
WORLD EVIDENCE RESEARCH.

5205
03:28:04,829 --> 03:28:07,565
THE FIRST BULLET HERE ON

5206
03:28:07,565 --> 03:28:09,200
MICROSIMULATION, WE HOSTED A

5207
03:28:09,200 --> 03:28:13,071
MEETING OF THE BIPARTISAN POLICY

5208
03:28:13,071 --> 03:28:14,505
CENTER SIX MONTHS AGO TRIED TO

5209
03:28:14,505 --> 03:28:17,175
BRING TOGETHER ACROSS THE

5210
03:28:17,175 --> 03:28:18,109
COUNTRY LEADING MICROSIMULATION

5211
03:28:18,109 --> 03:28:20,211
RESEARCH EXPERTS WHO ARE FOCUSED

5212
03:28:20,211 --> 03:28:23,815
ON TRYING TO EXAMINE WHAT ARE

5213
03:28:23,815 --> 03:28:25,383
THE FISCAL IMPACTS TO PUBLIC

5214
03:28:25,383 --> 03:28:28,219
PROGRAMS IN PARTICULAR FOR

5215
03:28:28,219 --> 03:28:30,054
COVERAGE OF ANTI-OBESITY

5216
03:28:30,054 --> 03:28:32,256
MEDICATION, CBO WAS THERE, MANY

5217
03:28:32,256 --> 03:28:34,359
FOLKS PROBABLY PARTICIPATING IN

5218
03:28:34,359 --> 03:28:35,793
TODAY'S WORKSHOP IN THAT

5219
03:28:35,793 --> 03:28:36,194
MEETING.

5220
03:28:36,194 --> 03:28:38,429
AND WE WENT THROUGH MANY OF THE

5221
03:28:38,429 --> 03:28:40,031
ASSUMPTIONS IT TAKES TO ESTIMATE

5222
03:28:40,031 --> 03:28:40,832
THE FISCAL IMPACT.

5223
03:28:40,832 --> 03:28:49,807
YOU GOT TO FIGURE OUT, WELL,

5224
03:28:49,807 --> 03:28:51,175
WHAT'S THE N, HOW MANY MILLIONS,

5225
03:28:51,175 --> 03:28:54,078
HOW MANY WANT TO TAKE IT, WHAT'S

5226
03:28:54,078 --> 03:28:58,116
THE ADHERENCE, WHAT ARE THE

5227
03:28:58,116 --> 03:28:59,984
PRICE OF MEDICATIONS, WITH

5228
03:28:59,984 --> 03:29:01,719
REBATES, NET PRICE, HOW MIGHT

5229
03:29:01,719 --> 03:29:03,154
NEGOTIATION IMPACT THIS, HOW

5230
03:29:03,154 --> 03:29:04,155
COULD MARKET COMPETITION IMPACT

5231
03:29:04,155 --> 03:29:06,791
THIS, WHAT ARE THE HEALTH

5232
03:29:06,791 --> 03:29:08,426
BENEFIT OFFSETS?

5233
03:29:08,426 --> 03:29:10,561
HOPEFULLY THIS WILL REDUCE

5234
03:29:10,561 --> 03:29:11,429
PREVENTIBLE HEALTH CARE

5235
03:29:11,429 --> 03:29:12,397
UTILIZATION, IMPROVE HEALTH,

5236
03:29:12,397 --> 03:29:15,266
WHAT ARE THE HEALTH BENEFITS,

5237
03:29:15,266 --> 03:29:16,200
WHAT ARE SOME OTHER ASSUMPTIONS,

5238
03:29:16,200 --> 03:29:19,170
SO A LOT OF THAT RESEARCH, A LOT

5239
03:29:19,170 --> 03:29:20,905
OF PLACES AROUND THE COUNTRY ARE

5240
03:29:20,905 --> 03:29:22,874
LOOKING AT THAT.

5241
03:29:22,874 --> 03:29:24,575
THERE'S A CITATION HERE FROM A

5242
03:29:24,575 --> 03:29:26,077
NICE STUDY THAT JUST CAME OUT

5243
03:29:26,077 --> 03:29:28,579
TWO WEEKS AGO IN JAMA HEALTH

5244
03:29:28,579 --> 03:29:31,649
FORUM, RESEARCHERS FROM CHICAGO

5245
03:29:31,649 --> 03:29:32,850
AND TUFTS AND MICHIGAN WHO

5246
03:29:32,850 --> 03:29:35,153
LOOKED AT THIS, AGAIN, LOOKING

5247
03:29:35,153 --> 03:29:36,154
AT DIFFERENT ASSUMPTIONS, THAT

5248
03:29:36,154 --> 03:29:39,524
WORK NEEDS TO CONTINUE.

5249
03:29:39,524 --> 03:29:42,160
AND THEN FINALLY IDENTIFYING

5250
03:29:42,160 --> 03:29:44,228
SUBPOPULATIONS WITH OBESITY FOR

5251
03:29:44,228 --> 03:29:46,864
WHOM INCREASED ACCESS TO

5252
03:29:46,864 --> 03:29:48,032
GLP-1s ARE MOST BENEFICIAL,

5253
03:29:48,032 --> 03:29:50,368
AND WE NEED A LOT OF REAL WORLD

5254
03:29:50,368 --> 03:29:51,269
EVIDENCE.

5255
03:29:51,269 --> 03:29:53,471
NOT JUST THE SUBPOPULATIONS, NOT

5256
03:29:53,471 --> 03:29:56,641
JUST FOR WHOM, IT'S HOW DO YOU

5257
03:29:56,641 --> 03:29:56,874
USE IT.

5258
03:29:56,874 --> 03:30:02,180
SO FOR WHOM, WITH WHAT, BACK TO

5259
03:30:02,180 --> 03:30:03,014
LIFESTYLE MODIFICATION PROGRAMS,

5260
03:30:03,014 --> 03:30:04,415
FOR HOW LONG, SO BACK TO

5261
03:30:04,415 --> 03:30:04,716
LIFESTYLE.

5262
03:30:04,716 --> 03:30:06,484
WHAT ARE THOSE LIFESTYLE AND

5263
03:30:06,484 --> 03:30:08,753
WEIGHT MANAGEMENT PROGRAMS MOST

5264
03:30:08,753 --> 03:30:09,654
EFFECTIVE AND COMPLEMENTING

5265
03:30:09,654 --> 03:30:10,788
GLP-1 DRUGS?

5266
03:30:10,788 --> 03:30:12,390
AND THEN FOR HOW LONG.

5267
03:30:12,390 --> 03:30:13,958
AND THIS IS REALLY NO PUN

5268
03:30:13,958 --> 03:30:15,760
INTENDED SORT OF THE MONEY

5269
03:30:15,760 --> 03:30:16,694
QUESTION.

5270
03:30:16,694 --> 03:30:19,597
IS THERE A CLINICALLY EFFECTIVE

5271
03:30:19,597 --> 03:30:22,133
SUSTAINABLE OFF-RAMP PATHWAY FOR

5272
03:30:22,133 --> 03:30:23,868
GLP-1s, ONCE SOMEBODY GETS TO

5273
03:30:23,868 --> 03:30:26,838
TARGET WEIGHT LOSS, ONCE

5274
03:30:26,838 --> 03:30:27,538
SOMEBODY ACHIEVES CLINICAL

5275
03:30:27,538 --> 03:30:28,506
IMPACT, WHERE WHETHER IT'S SIX

5276
03:30:28,506 --> 03:30:30,641
MONTHS OR A YEAR OR TWO YEARS

5277
03:30:30,641 --> 03:30:33,377
WHERE YOU CAN SAFELY COME OFF

5278
03:30:33,377 --> 03:30:35,313
THESE MEDICATIONS AND THEN YOU

5279
03:30:35,313 --> 03:30:45,056
MAY NEED -- MAYBE YOU NEED OTHER

5280
03:30:45,056 --> 03:30:46,557
NON-GLP-1 MEDICATIONS, LIFESTYLE

5281
03:30:46,557 --> 03:30:50,061
AND DIET MANAGEMENT, THE

5282
03:30:50,061 --> 03:30:52,830
OFF-RAMP PATHWAY THAT'S

5283
03:30:52,830 --> 03:30:54,432
SUSTAINABLE, THESE AREAS WOULD

5284
03:30:54,432 --> 03:30:56,300
BENEFIT FROM URGENT NEED FOR

5285
03:30:56,300 --> 03:30:58,069
REAL WORLD EVIDENCE THERE.

5286
03:30:58,069 --> 03:31:01,472
SO I WILL STOP THERE AND REALLY

5287
03:31:01,472 --> 03:31:03,875
LOOKING FORWARD TO THE

5288
03:31:03,875 --> 03:31:05,610
DISCUSSION AFTER THE NEXT FEW

5289
03:31:05,610 --> 03:31:05,977
PANELISTS.

5290
03:31:05,977 --> 03:31:07,245
THANK YOU FOR ALLOWING ME THE

5291
03:31:07,245 --> 03:31:12,950
OPPORTUNITY TO PRESENT TO YOU.

5292
03:31:12,950 --> 03:31:13,284
>> GREAT.

5293
03:31:13,284 --> 03:31:14,719
THANK YOU SO MUCH.

5294
03:31:14,719 --> 03:31:14,986
FANTASTIC.

5295
03:31:14,986 --> 03:31:17,321
I ALREADY HAVE A NUMBER OF

5296
03:31:17,321 --> 03:31:18,055
QUESTIONS.

5297
03:31:18,055 --> 03:31:21,826
WE'LL DO OUR Q&A AT THE END.

5298
03:31:21,826 --> 03:31:27,431
NEXT SPEAKER, I'D LIKE TO

5299
03:31:27,431 --> 03:31:29,100
INTRODUCE DR. NOELIA DUCHOVNY,

5300
03:31:29,100 --> 03:31:30,835
CONGRESSIONAL BUDGET OFFICE, 20

5301
03:31:30,835 --> 03:31:32,236
YEARS OF EXPERIENCE CONDUCTING

5302
03:31:32,236 --> 03:31:34,205
HEALTH POLICY RESEARCH ON

5303
03:31:34,205 --> 03:31:35,306
POLICIES RELATED TO POPULATION

5304
03:31:35,306 --> 03:31:37,608
HEALTH CONCERNS LIKE OBESITY AND

5305
03:31:37,608 --> 03:31:39,877
SUBSTANCE USE, ON THE FEDERAL

5306
03:31:39,877 --> 03:31:40,111
BUDGET.

5307
03:31:40,111 --> 03:31:44,282
DR.  DUCHOVNY WILL SHARE FROM TE

5308
03:31:44,282 --> 03:31:45,483
CONGRESSIONAL BUDGET OFFICE

5309
03:31:45,483 --> 03:31:47,451
REGARDING COVERAGE OF

5310
03:31:47,451 --> 03:31:53,024
MEDICATIONS TO TREAT OBESITY.

5311
03:31:53,024 --> 03:32:00,598
>> LET ME SHARE MY SLICES
-- SL 

5312
03:32:00,598 --> 03:32:01,065
PERFECT.

5313
03:32:01,065 --> 03:32:02,733
THANK YOU.

5314
03:32:02,733 --> 03:32:08,039
GOOD AFTERNOON.

5315
03:32:08,039 --> 03:32:09,707
I'M GOING TO BE SPEAKING ABOUT

5316
03:32:09,707 --> 03:32:12,310
MY WORK AT THE CONGRESSIONAL

5317
03:32:12,310 --> 03:32:14,612
BUDGET OFFICE, AND I WILL BE

5318
03:32:14,612 --> 03:32:18,816
MAKING -- I WANT TO TOUCH ON

5319
03:32:18,816 --> 03:32:20,852
THREE ASPECTS OF THE WORK.

5320
03:32:20,852 --> 03:32:24,021
FIRST, I WOULD LIKE TO TELL YOU

5321
03:32:24,021 --> 03:32:27,525
ABOUT THE WORK THAT WE DO AT THE

5322
03:32:27,525 --> 03:32:28,526
CONGRESSIONAL BUDGET OFFICE, IN

5323
03:32:28,526 --> 03:32:30,461
CASE YOU'RE NOT VERY FAMILIAR

5324
03:32:30,461 --> 03:32:31,128
WITH OUR OFFICE.

5325
03:32:31,128 --> 03:32:34,098
I WANT TO TALK ABOUT THE REPORTS

5326
03:32:34,098 --> 03:32:38,736
THAT WE PUT OUT IN LAST OCTOBER,

5327
03:32:38,736 --> 03:32:39,737
THAT ANAND MENTIONED.

5328
03:32:39,737 --> 03:32:43,941
THEN I'M GOING TO TALK ABOUT THE

5329
03:32:43,941 --> 03:32:45,243
MAJOR AREAS OF UNCERTAINTY.

5330
03:32:45,243 --> 03:32:49,213
ALL THESE TOPICS WILL SOUND VERY

5331
03:32:49,213 --> 03:32:52,350
FAMILIAR BECAUSE THEY HAVE

5332
03:32:52,350 --> 03:32:55,086
ALREADY BEEN DISCUSSED BY PRIOR

5333
03:32:55,086 --> 03:32:55,519
SPEAKERS.

5334
03:32:55,519 --> 03:32:58,923
SO I HAVE NO CONFLICTS OF

5335
03:32:58,923 --> 03:32:59,190
INTEREST.

5336
03:32:59,190 --> 03:33:06,964
SO LET ME START BY TALKING ABOUT

5337
03:33:06,964 --> 03:33:08,566
THE POLICY MAKING PROCESS.

5338
03:33:08,566 --> 03:33:10,468
TIMES OF INFORMATION CBO

5339
03:33:10,468 --> 03:33:13,938
GENERALLY PROVIDES TO CONGRESS

5340
03:33:13,938 --> 03:33:16,107
INCLUDES BASELINE PROJECTIONS,

5341
03:33:16,107 --> 03:33:18,309
THOSE ARE PROJECTION OF FEDERAL

5342
03:33:18,309 --> 03:33:19,944
SPENDING AND REVENUE UNDER

5343
03:33:19,944 --> 03:33:23,481
CURRENT LAW TO HELP FORMULATE

5344
03:33:23,481 --> 03:33:25,349
BUDGET.

5345
03:33:25,349 --> 03:33:28,052
AS AN EXAMPLE, MY COLLEAGUE WHO

5346
03:33:28,052 --> 03:33:30,988
DOES PROJECTIONS FOR MEDICARE

5347
03:33:30,988 --> 03:33:33,524
ENROLLMENT AND SPENDING FOR THE

5348
03:33:33,524 --> 03:33:35,293
NEXT TEN YEARS.

5349
03:33:35,293 --> 03:33:38,429
AND THEN CONGRESSIONAL BUDGET

5350
03:33:38,429 --> 03:33:39,997
OFFICE IS ALSO CHARGED WITH

5351
03:33:39,997 --> 03:33:43,401
DOING COST ESTIMATES OF

5352
03:33:43,401 --> 03:33:45,803
LEGISLATIVE PROPOSALS, AND THOSE

5353
03:33:45,803 --> 03:33:48,339
LEGISLATIVE PROPOSALS ARE

5354
03:33:48,339 --> 03:33:51,409
MEASURED AGAINST BASELINE

5355
03:33:51,409 --> 03:33:53,044
PROJECTIONS.

5356
03:33:53,044 --> 03:33:55,346
WE -- THE AGENCY ALSO LOOKS AT

5357
03:33:55,346 --> 03:33:57,548
ESTIMATES OF ECONOMIC AND

5358
03:33:57,548 --> 03:33:59,984
BUDGETARY EFFECTS OF DIFFERENT

5359
03:33:59,984 --> 03:34:02,153
POLICY OPTIONS.

5360
03:34:02,153 --> 03:34:04,221
AND IMPORTANTLY, CBO IS STRICTLY

5361
03:34:04,221 --> 03:34:10,361
NONPARTISAN AND DOES NOT MAKE

5362
03:34:10,361 --> 03:34:11,262
POLICY RECOMMENDATIONS.

5363
03:34:11,262 --> 03:34:14,065
GOING BACK TO THE COST

5364
03:34:14,065 --> 03:34:16,801
ESTIMATES, THOSE ESTIMATES HAVE

5365
03:34:16,801 --> 03:34:17,301
CERTAIN CHARACTERISTICS.

5366
03:34:17,301 --> 03:34:21,806
FOR THE MOST PART THEY FOCUS ON

5367
03:34:21,806 --> 03:34:25,209
THE NEXT TEN YEARS, BUT

5368
03:34:25,209 --> 03:34:26,744
SOMETIMES LOOK 20 YEARS OR MORE

5369
03:34:26,744 --> 03:34:28,279
INTO THE FUTURE.

5370
03:34:28,279 --> 03:34:29,947
THIS IS ESPECIALLY IMPORTANT IN

5371
03:34:29,947 --> 03:34:34,452
CERTAIN POLICIES, FOR EXAMPLE,

5372
03:34:34,452 --> 03:34:38,055
RELATED TO PREVENTION AND YOU

5373
03:34:38,055 --> 03:34:39,690
MIGHT EXPECT THAT THE COST OF

5374
03:34:39,690 --> 03:34:42,126
COVERING A NEW PREVENTIVE

5375
03:34:42,126 --> 03:34:43,995
SERVICE MIGHT COME EARLY IN THE

5376
03:34:43,995 --> 03:34:45,997
BUDGET WINDOW, THIS TEN YEARS,

5377
03:34:45,997 --> 03:34:47,164
BUT THE BENEFITS WON'T COME

5378
03:34:47,164 --> 03:34:48,032
UNTIL MUCH LATER.

5379
03:34:48,032 --> 03:34:51,535
SO IT'S IMPORTANT FOR US TO --

5380
03:34:51,535 --> 03:34:54,405
WHEN WE CAN, WE ESTIMATE EFFECTS

5381
03:34:54,405 --> 03:34:58,576
IN NOT ONLY TEN YEARS BUT TWENTY

5382
03:34:58,576 --> 03:35:01,645
YEARS, AND AT THE VERY LEAST TRY

5383
03:35:01,645 --> 03:35:05,082
TO GIVE THE CONGRESS

5384
03:35:05,082 --> 03:35:05,616
INFORMATION, SUPPLEMENTAL

5385
03:35:05,616 --> 03:35:09,286
INFORMATION, ON WHAT HAPPENS

5386
03:35:09,286 --> 03:35:10,821
AFTER THE FIRST DECADE.

5387
03:35:10,821 --> 03:35:12,356
ESTIMATES REFLECT MIDDLE OF

5388
03:35:12,356 --> 03:35:14,725
DISTRIBUTION OF LIKELY OUTCOMES.

5389
03:35:14,725 --> 03:35:15,559
THEY INCORPORATE BEHAVIORAL

5390
03:35:15,559 --> 03:35:19,764
RESPONSES TO THE EXTENT

5391
03:35:19,764 --> 03:35:22,733
POSSIBLE, THAT MEANS WE RELY ON

5392
03:35:22,733 --> 03:35:23,634
AVAILABLE EVIDENCE.

5393
03:35:23,634 --> 03:35:26,904
ESTIMATES MAY BE UPDATED IF NEW

5394
03:35:26,904 --> 03:35:27,838
INFORMATION BECOMES AVAILABLE,

5395
03:35:27,838 --> 03:35:30,174
AND CAN CHANGE AS A RESULT.

5396
03:35:30,174 --> 03:35:33,677
AND WHEN WE PUT OUT ESTIMATES,

5397
03:35:33,677 --> 03:35:37,715
WE INCLUDE EXPLANATIONS OF THE

5398
03:35:37,715 --> 03:35:40,484
ANALYSIS TO THE EXTENT POSSIBLE.

5399
03:35:40,484 --> 03:35:43,854
SO ASSESSMENTS ARE BASED ON

5400
03:35:43,854 --> 03:35:45,156
DETAIL ANALYSIS, INCLUDING DEEP

5401
03:35:45,156 --> 03:35:47,458
UNDERSTANDING OF FEDERAL

5402
03:35:47,458 --> 03:35:52,396
PROGRAMS AND REVENUE RESOURCES,

5403
03:35:52,396 --> 03:35:53,497
EXAMINATION OF RELEVANT RESEARCH

5404
03:35:53,497 --> 03:35:55,266
LITERATURE AND ANALYSIS OF DATA

5405
03:35:55,266 --> 03:35:59,937
REPORTED BY FEDERAL AGENCIES.

5406
03:35:59,937 --> 03:36:01,806
WE RELY HEAVILY ON OUTSIDE

5407
03:36:01,806 --> 03:36:04,308
EXPERTS IN ACADEMIA, THINK

5408
03:36:04,308 --> 03:36:05,976
TANKS, INDUSTRY GROUPS, PRIVATE

5409
03:36:05,976 --> 03:36:07,144
SECTOR, FEDERAL, STATE, AND

5410
03:36:07,144 --> 03:36:07,978
LOCAL AGENCIES.

5411
03:36:07,978 --> 03:36:12,450
AND YOU'LL SEE ALL OF THESE

5412
03:36:12,450 --> 03:36:16,053
REFLECTED WHEN I TALK ABOUT OUR

5413
03:36:16,053 --> 03:36:17,755
ESTIMATE OF COVERAGE OF

5414
03:36:17,755 --> 03:36:25,329
ANTI-OBESITY MEDICATIONS.

5415
03:36:25,329 --> 03:36:29,066
WE ALSO HAVE TWO PANELS, ONE IS

5416
03:36:29,066 --> 03:36:30,367
MORE TARGETED TO MACROECONOMIC

5417
03:36:30,367 --> 03:36:33,237
ISSUES, AND THERE'S A SECOND

5418
03:36:33,237 --> 03:36:36,540
PANEL OF HEALTH ADVISORS.

5419
03:36:36,540 --> 03:36:40,478
NOW TURNING TO THE ESTIMATE OF

5420
03:36:40,478 --> 03:36:43,547
MEDICARE COVERAGE OF

5421
03:36:43,547 --> 03:36:45,116
ANTI-OBESITY MEDICATIONS, ANAND

5422
03:36:45,116 --> 03:36:47,184
DISCUSSED THIS BUT JUST BRIEFLY

5423
03:36:47,184 --> 03:36:51,355
MEDICARE DOES COVER SOME

5424
03:36:51,355 --> 03:36:53,524
TREATMENTS FOR OBESITY THAT

5425
03:36:53,524 --> 03:36:55,493
INCLUDES BARIATRIC SURGERY,

5426
03:36:55,493 --> 03:36:56,694
COUNSELING AND OBESITY

5427
03:36:56,694 --> 03:36:59,430
SCREENINGS, BEHAVIORAL THERAPY.

5428
03:36:59,430 --> 03:37:03,033
PART D PROHIBITED FROM COVERING

5429
03:37:03,033 --> 03:37:06,670
PRESCRIPTION DRUGS OR AOMs FOR

5430
03:37:06,670 --> 03:37:10,708
WEIGHT LOSS BUT CAN COVER THOSE

5431
03:37:10,708 --> 03:37:11,876
MEDICATIONS FOR THINGS LIKE TYPE

5432
03:37:11,876 --> 03:37:16,280
2 DIABETES AND CARDIOVASCULAR

5433
03:37:16,280 --> 03:37:16,814
DISEASE.

5434
03:37:16,814 --> 03:37:22,419
SO AS I MENTIONED IN LAST

5435
03:37:22,419 --> 03:37:25,789
OCTOBER WE PUBLISHED A REPORT

5436
03:37:25,789 --> 03:37:28,292
LOOKING AT POLICY THAT WOULD

5437
03:37:28,292 --> 03:37:32,363
AUTHORIZE MEDICARE PART D TO

5438
03:37:32,363 --> 03:37:33,998
COVER ANTI-OBESITY MEDICATIONS,

5439
03:37:33,998 --> 03:37:36,066
AND THAT REPORT CONCLUDED THAT

5440
03:37:36,066 --> 03:37:37,501
THAT COVERAGE WOULD COST THE

5441
03:37:37,501 --> 03:37:40,371
FEDERAL GOVERNMENT MORE THAN IT

5442
03:37:40,371 --> 03:37:42,540
WOULD SAVE FROM REDUCING OTHER

5443
03:37:42,540 --> 03:37:44,742
HEALTHCARE SPENDING LEADING TO

5444
03:37:44,742 --> 03:37:48,145
OVERALL INCREASE IN THE DEFICIT.

5445
03:37:48,145 --> 03:37:51,215
SO THIS TABLE SHOWS THE EFFECT

5446
03:37:51,215 --> 03:37:54,018
ON THE DEFICIT WHICH OVER TEN

5447
03:37:54,018 --> 03:37:56,520
YEARS THAT'S THE TOTAL, THE VERY

5448
03:37:56,520 --> 03:38:00,391
LAST COLUMN, WOULD INCREASE

5449
03:38:00,391 --> 03:38:03,994
DEFICIT BY $35.5 BILLION, AND

5450
03:38:03,994 --> 03:38:04,862
THAT'S COMBINATION OF DIRECT

5451
03:38:04,862 --> 03:38:08,699
COST OF POLICY WHICH WOULD

5452
03:38:08,699 --> 03:38:09,767
INCREASE DEFICIT BY ALMOST $39

5453
03:38:09,767 --> 03:38:12,636
BILLION, OVER THOSE TEN YEARS,

5454
03:38:12,636 --> 03:38:17,575
AND SAVINGS FROM IMPROVED HEALTH

5455
03:38:17,575 --> 03:38:19,577
THAT WOULD REDUCE BY

5456
03:38:19,577 --> 03:38:20,144
$3.4 BILLION.

5457
03:38:20,144 --> 03:38:25,849
SO LESS THAN 10% OFFSET IN

5458
03:38:25,849 --> 03:38:26,116
INCREASE.

5459
03:38:26,116 --> 03:38:29,186
SHOULD BE NOTED FUTURE ESTIMATES

5460
03:38:29,186 --> 03:38:35,359
OF THE SAME POLICY COULD DIFFER

5461
03:38:35,359 --> 03:38:36,894
BECAUSE OF DIFFERENT POLICY

5462
03:38:36,894 --> 03:38:38,095
SPECIFICATIONS, CHANGES IN

5463
03:38:38,095 --> 03:38:40,264
BASELINE PROJECTIONS, ABILITY OF

5464
03:38:40,264 --> 03:38:44,468
NEW EVIDENCE AND IMPROVEMENT IN

5465
03:38:44,468 --> 03:38:46,837
CBO'S ESTIMATING POLICY.

5466
03:38:46,837 --> 03:38:50,774
ESTIMATED METHODOLOGY, SORRY.

5467
03:38:50,774 --> 03:38:54,712
SO, LET ME BREAK DOWN AND TALK

5468
03:38:54,712 --> 03:38:57,314
ABOUT THE DIFFERENT COMPONENTS

5469
03:38:57,314 --> 03:38:59,316
THAT WENT INTO COMING UP WITH

5470
03:38:59,316 --> 03:39:00,384
THOSE ESTIMATES.

5471
03:39:00,384 --> 03:39:04,255
AND THE SOURCES OF DATA THAT WE

5472
03:39:04,255 --> 03:39:09,827
USED TO GET AT SPECIFIC

5473
03:39:09,827 --> 03:39:10,227
PARAMETERS.

5474
03:39:10,227 --> 03:39:14,064
SO, DIRECT COSTS THAT OUTLINE IN

5475
03:39:14,064 --> 03:39:15,266
THE PREVIOUS TABLE ARE

5476
03:39:15,266 --> 03:39:17,234
DETERMINED BY TWO FACTORS.

5477
03:39:17,234 --> 03:39:18,769
THE USE OF THE MEDICATIONS AND

5478
03:39:18,769 --> 03:39:24,675
THE PRICE OF THE MEDICATIONS.

5479
03:39:24,675 --> 03:39:28,779
USE IS IN TURN A FUNCTION OF THE

5480
03:39:28,779 --> 03:39:33,484
NUMBER OF ENROLLEES ELIGIBLE FOR

5481
03:39:33,484 --> 03:39:35,419
COVERAGE OF AOMs, TAKEUP OF

5482
03:39:35,419 --> 03:39:36,487
THOSE MEDICATIONS AND DURATION

5483
03:39:36,487 --> 03:39:37,821
OF THE TREATMENT.

5484
03:39:37,821 --> 03:39:40,224
LET ME TAKE EACH ONE OF THESE

5485
03:39:40,224 --> 03:39:41,558
FACTORS AND GIVE YOU A LITTLE

5486
03:39:41,558 --> 03:39:42,092
MORE DETAIL.

5487
03:39:42,092 --> 03:39:45,896
TO ESTIMATE THE NUMBER OF

5488
03:39:45,896 --> 03:39:47,998
ENROLLEES ELIGIBLE FOR COVERAGE

5489
03:39:47,998 --> 03:39:53,270
WE STARTED WITH THE TOTAL NUMBER

5490
03:39:53,270 --> 03:39:54,471
OF ENROLLEES WITH OBESITY OR

5491
03:39:54,471 --> 03:39:59,143
THAT FELL IN THE OVERWEIGHT

5492
03:39:59,143 --> 03:40:04,214
CATEGORY AND HAD CO-MORBIDITIES,

5493
03:40:04,214 --> 03:40:09,653
AND WE PUT THAT I THINK ALMOST

5494
03:40:09,653 --> 03:40:13,324
ABOUT 30 MILLION ENROLLEES, USED

5495
03:40:13,324 --> 03:40:17,394
SURVEY DATA WHICH WE WERE ABLE

5496
03:40:17,394 --> 03:40:20,664
TO IDENTIFY PEOPLE IN MEDICARE,

5497
03:40:20,664 --> 03:40:25,302
PEOPLE ENROLLED IN MEDICARE,

5498
03:40:25,302 --> 03:40:28,372
WITH SELF-REPORTED BMI AND

5499
03:40:28,372 --> 03:40:30,107
MEDICAL CONDITIONS.

5500
03:40:30,107 --> 03:40:32,643
FROM THAT, WE SUBTRACTED THE

5501
03:40:32,643 --> 03:40:34,411
NUMBER OF PEOPLE WITH DIABETES,

5502
03:40:34,411 --> 03:40:36,680
BECAUSE THOSE PEOPLE WOULDN'T BE

5503
03:40:36,680 --> 03:40:39,550
NEWLY ELIGIBLE UNDER THE POLICY,

5504
03:40:39,550 --> 03:40:44,121
THEY ARE ALREADY ELIGIBLE.

5505
03:40:44,121 --> 03:40:46,857
AND WE HAVE TO THINK, DEDUCTED

5506
03:40:46,857 --> 03:40:50,027
NUMBER OF PEOPLE WITH

5507
03:40:50,027 --> 03:40:52,463
CARDIOVASCULAR INDICATIONS, AND

5508
03:40:52,463 --> 03:40:55,866
HAD TO THINK ABOUT NOT ONLY

5509
03:40:55,866 --> 03:41:04,174
WHAT'S HAPPENING RIGHT NOW BUT

5510
03:41:04,174 --> 03:41:11,048
ALSO WE HAD TO HAVE INDICATIONS

5511
03:41:11,048 --> 03:41:13,584
TO BE COVERED IN THE NEXT TEN

5512
03:41:13,584 --> 03:41:14,785
YEARS, LOOKED AT ONGOING

5513
03:41:14,785 --> 03:41:15,986
CLINICAL TRIALS AND, YOU KNOW,

5514
03:41:15,986 --> 03:41:22,226
WE SAID IN THE NEXT TEN YEARS

5515
03:41:22,226 --> 03:41:24,528
THERE'S PROBABILITY NEW

5516
03:41:24,528 --> 03:41:25,729
INDICATION MIGHT BE COVERED, SO

5517
03:41:25,729 --> 03:41:30,868
THAT REDUCES THE NUMBER OF

5518
03:41:30,868 --> 03:41:34,471
PEOPLE NEWLY ELIGIBLE TO RECEIVE

5519
03:41:34,471 --> 03:41:35,272
MEDICARE COVERAGE, THESE

5520
03:41:35,272 --> 03:41:38,976
MEDICATIONS FOR WEIGHT LOSS

5521
03:41:38,976 --> 03:41:39,309
ONLY.

5522
03:41:39,309 --> 03:41:48,952
SO I THINK JUST TO GIVE A SENSE

5523
03:41:48,952 --> 03:41:53,223
IN 2025, ABOUT 30% OF PEOPLE

5524
03:41:53,223 --> 03:41:58,796
EITHER WITH OBESITY OR

5525
03:41:58,796 --> 03:41:59,897
OVERWEIGHT AND CO-MORBIDITIES

5526
03:41:59,897 --> 03:42:03,834
CAN GET ACCESS TO MEDICATIONS

5527
03:42:03,834 --> 03:42:06,069
BECAUSE THEY ALSO HAVE DIABETES

5528
03:42:06,069 --> 03:42:07,337
OR CARDIOVASCULAR INDICATIONS.

5529
03:42:07,337 --> 03:42:10,407
BY THE END OF THE BUDGET WINDOW,

5530
03:42:10,407 --> 03:42:15,045
SO IN YEAR 10 OF THE POLICY, WE

5531
03:42:15,045 --> 03:42:19,149
SAID THAT 50% OF PEOPLE AMONG

5532
03:42:19,149 --> 03:42:22,319
THIS GROUP OF MEDICARE ENROLLEES

5533
03:42:22,319 --> 03:42:24,154
EITHER WITH OBESITY OR

5534
03:42:24,154 --> 03:42:25,956
OVERWEIGHT AND COMORBIDITIES

5535
03:42:25,956 --> 03:42:31,628
WOULD BE ELIGIBLE UNDER CURRENT

5536
03:42:31,628 --> 03:42:32,830
LAW.

5537
03:42:32,830 --> 03:42:38,836
WE ALSO HAD TO IS SPECIFY

5538
03:42:38,836 --> 03:42:41,705
TAKEUPS OF MEDICATIONS AMONG

5539
03:42:41,705 --> 03:42:45,409
PEOPLE NEWLY ELIGIBLE, AND WE

5540
03:42:45,409 --> 03:42:47,744
USED SOME RELATED DATA.

5541
03:42:47,744 --> 03:42:49,913
WE TALKED TO EXPERTS.

5542
03:42:49,913 --> 03:42:54,051
AND I THINK ANAND ALSO MENTIONED

5543
03:42:54,051 --> 03:42:57,688
THIS, WE CAME UP WITH AN

5544
03:42:57,688 --> 03:42:59,523
ESTIMATE THAT ABOUT 2% OF PEOPLE

5545
03:42:59,523 --> 03:43:01,825
NEWLY ELIGIBLE TO RECEIVE THESE

5546
03:43:01,825 --> 03:43:02,860
MEDICATIONS WOULD TAKE IT UP IN

5547
03:43:02,860 --> 03:43:06,864
THE FIRST YEAR OF THE POLICY, IN

5548
03:43:06,864 --> 03:43:08,732
2026, GROWING TO 14% BY THE END

5549
03:43:08,732 --> 03:43:10,934
OF THE BUDGET WINDOW.

5550
03:43:10,934 --> 03:43:14,137
AND THEN WITH DURATION OF

5551
03:43:14,137 --> 03:43:17,541
TREATMENT, AGAIN, WE USED SOME

5552
03:43:17,541 --> 03:43:23,180
AVAILABLE DATA, AND OVER TIME WE

5553
03:43:23,180 --> 03:43:25,716
SEE PEOPLE STAYING ON THE

5554
03:43:25,716 --> 03:43:27,317
MEDICATION FOR LONGER.

5555
03:43:27,317 --> 03:43:28,886
SO THAT'S USE.

5556
03:43:28,886 --> 03:43:34,124
IN TERMS OF PRICE, LIST

5557
03:43:34,124 --> 03:43:36,193
PRICES -- I THINK THIS IS STILL

5558
03:43:36,193 --> 03:43:39,263
TRUE, JUST OVER A THOUSAND

5559
03:43:39,263 --> 03:43:42,466
DOLLARS, FEDERAL GOVERNMENT PAID

5560
03:43:42,466 --> 03:43:45,536
LESS THAN THAT BECAUSE OF

5561
03:43:45,536 --> 03:43:48,472
REBATES; COST SHARING AND OTHER

5562
03:43:48,472 --> 03:43:52,175
FACTORS. 

5563
03:43:52,175 --> 03:43:57,414
IN TERMS OF FUTURE PRICES ANAND

5564
03:43:57,414 --> 03:44:00,284
MENTIONED THERE WILL BE PRICE

5565
03:44:00,284 --> 03:44:03,086
NEGOTIATION STARTING IN 2017, WE

5566
03:44:03,086 --> 03:44:06,790
EXPECT THAT THERE WILL BE

5567
03:44:06,790 --> 03:44:07,991
SPILLOVERS AND THE PRICE WILL

5568
03:44:07,991 --> 03:44:12,696
ALSO GO DOWN AND GOING FORWARD

5569
03:44:12,696 --> 03:44:13,997
WE EXPECT GENERIC COMPETITIONS

5570
03:44:13,997 --> 03:44:16,266
WHICH WOULD DRIVE DOWN PRICES,

5571
03:44:16,266 --> 03:44:20,771
AND NEW PRODUCTS THAT COULD BE

5572
03:44:20,771 --> 03:44:24,174
MORE EFFICIENT AND EXISTING

5573
03:44:24,174 --> 03:44:26,009
PRODUCTS MIGHT HAVE HIGHER

5574
03:44:26,009 --> 03:44:33,917
PRICES, SO THERE'S SOME PUSH AND

5575
03:44:33,917 --> 03:44:38,188
PULL HERE, AND -- OKAY.

5576
03:44:38,188 --> 03:44:43,894
SO, IN TERMS OF OFFSETTING

5577
03:44:43,894 --> 03:44:47,130
BUDGETARY SAVINGS, CBO IS NOT

5578
03:44:47,130 --> 03:44:49,766
AWARE OF EMPIRICAL EVIDENCE THAT

5579
03:44:49,766 --> 03:44:52,703
DIRECTLY LINKS AOM USE TO

5580
03:44:52,703 --> 03:44:53,937
REDUCTION IN HEALTH CARE

5581
03:44:53,937 --> 03:44:59,710
SPENDING FROM IMPROVED HEALTH.

5582
03:44:59,710 --> 03:45:03,213
SO, WE INSTEAD LOOKED AT TWO

5583
03:45:03,213 --> 03:45:05,449
COMPARABLE TYPES OF RESEARCH.

5584
03:45:05,449 --> 03:45:06,850
THE FIRST CAME FROM

5585
03:45:06,850 --> 03:45:08,385
OBSERVATIONAL STUDIES THAT

5586
03:45:08,385 --> 03:45:10,687
LOOKED AT EFFECTS OF BARIATRIC

5587
03:45:10,687 --> 03:45:13,056
SURGERY ON HEALTHCARE SPENDING

5588
03:45:13,056 --> 03:45:19,196
AND SECOND ONE THAT ALREADY BEEN

5589
03:45:19,196 --> 03:45:19,896
MENTIONED IS MICROSIMULATION

5590
03:45:19,896 --> 03:45:21,498
STUDIES, WE LOOKED AT TWO.

5591
03:45:21,498 --> 03:45:23,667
LET ME START BY TELLING YOU

5592
03:45:23,667 --> 03:45:27,004
ABOUT THE OBSERVATIONAL STUDIES

5593
03:45:27,004 --> 03:45:28,839
ON BARIATRIC SURGERY.

5594
03:45:28,839 --> 03:45:31,775
EVIDENCE IS MIXED.

5595
03:45:31,775 --> 03:45:33,744
STUDIES SHOW THAT BARIATRIC

5596
03:45:33,744 --> 03:45:35,412
SURGERY INCREASES SPENDING OVER

5597
03:45:35,412 --> 03:45:35,912
TIME.

5598
03:45:35,912 --> 03:45:38,882
THERE'S SOME THAT SHOW NO

5599
03:45:38,882 --> 03:45:42,519
CHANGE, SOME THAT SHOW LOWER

5600
03:45:42,519 --> 03:45:45,055
SPENDING. 

5601
03:45:45,055 --> 03:45:47,791
SO WE TOOK THOSE STUDIES.

5602
03:45:47,791 --> 03:45:49,960
WE MADE SOME ADJUSTMENTS BECAUSE

5603
03:45:49,960 --> 03:45:52,195
THOSE STUDIES AT LEAST SOME OF

5604
03:45:52,195 --> 03:45:56,233
THEM, MAYBE ALL OF THEM, WERE

5605
03:45:56,233 --> 03:45:57,768
BASED ON PRIVATE PAYERS, SO WE

5606
03:45:57,768 --> 03:46:01,805
HAD TO CONVERT PRICES TO

5607
03:46:01,805 --> 03:46:03,140
MEDICARE PRICES.

5608
03:46:03,140 --> 03:46:08,278
WE LOOKED AT THE STRENGTH OF THE

5609
03:46:08,278 --> 03:46:10,180
STUDY DESIGN, SO WE BASICALLY

5610
03:46:10,180 --> 03:46:17,487
GAVE EACH OF THE STUDIES THE

5611
03:46:17,487 --> 03:46:21,525
WEIGHT, AND STUDIES WITH BETTER

5612
03:46:21,525 --> 03:46:22,726
CONTROL, BETTER MATCHING BETWEEN

5613
03:46:22,726 --> 03:46:28,198
GROUPS THAT DID AND DID NOT

5614
03:46:28,198 --> 03:46:31,735
UNDERGO BARIATRIC SURGERY HAD

5615
03:46:31,735 --> 03:46:33,570
HIGHER WEIGHT, STUDIES THAT HAD

5616
03:46:33,570 --> 03:46:36,206
LOWER ATTRITION HAD HIGHER

5617
03:46:36,206 --> 03:46:39,943
WEIGHT, AND VICE VERSA.

5618
03:46:39,943 --> 03:46:42,546
AND FROM -- YOU KNOW, AFTER

5619
03:46:42,546 --> 03:46:45,148
MAKING THOSE ADJUSTMENTS WE CAME

5620
03:46:45,148 --> 03:46:52,055
UP WITH A STREAM OF NUMBERS

5621
03:46:52,055 --> 03:46:54,291
SHOWING IMPACT FROM IMPROVED

5622
03:46:54,291 --> 03:46:58,095
HEALTH, THE YEAR AFTER PEOPLE

5623
03:46:58,095 --> 03:46:59,930
HAD BARIATRIC SURGERY, YEAR ONE

5624
03:46:59,930 --> 03:47:01,665
THROUGH YOU'RE TEN AND TOOK INTO

5625
03:47:01,665 --> 03:47:05,836
ACCOUNT THE FACT THAT HAVING

5626
03:47:05,836 --> 03:47:08,572
BARIATRIC SURGERY IS DIFFERENT

5627
03:47:08,572 --> 03:47:10,874
FROM TAKING OR GETTING AN

5628
03:47:10,874 --> 03:47:11,341
INJECTION.

5629
03:47:11,341 --> 03:47:13,110
YOU DON'T HAVE ALL THE

5630
03:47:13,110 --> 03:47:15,278
COMPLICATIONS THAT YOU MIGHT

5631
03:47:15,278 --> 03:47:16,546
HAVE FROM BARIATRIC SURGERY, SO

5632
03:47:16,546 --> 03:47:20,484
WE KIND OF TRIED TO ZERO THAT

5633
03:47:20,484 --> 03:47:20,917
OUT.

5634
03:47:20,917 --> 03:47:25,756
SO THERE ISN'T AN INCREASE IN

5635
03:47:25,756 --> 03:47:29,226
SPENDING FOR EXAMPLE FROM

5636
03:47:29,226 --> 03:47:29,559
COMPLICATIONS.

5637
03:47:29,559 --> 03:47:31,228
SIMILARLY FOR MICROSIMULATION WE

5638
03:47:31,228 --> 03:47:33,430
LOOKED AT TWO MICROSIMULATION

5639
03:47:33,430 --> 03:47:33,663
STUDIES.

5640
03:47:33,663 --> 03:47:38,235
ONE FROM KAISER AND ONE FROM THE

5641
03:47:38,235 --> 03:47:41,404
UNIVERSITY OF SOUTHERN

5642
03:47:41,404 --> 03:47:41,872
CALIFORNIA.

5643
03:47:41,872 --> 03:47:45,175
AND THOSE STUDIES, WE AVERAGED

5644
03:47:45,175 --> 03:47:45,509
THEM.

5645
03:47:45,509 --> 03:47:48,445
WE AVERAGED THE RESULTS TOGETHER

5646
03:47:48,445 --> 03:47:51,715
AND AGAIN CAME UP WITH STREAM OF

5647
03:47:51,715 --> 03:47:53,450
SAVINGS FOR PEOPLE TAKING THE

5648
03:47:53,450 --> 03:47:55,385
MEDICATION FOR ONE YEAR, TWO

5649
03:47:55,385 --> 03:47:59,456
YEARS, THREE YEARS AND SO FORTH.

5650
03:47:59,456 --> 03:48:01,558
TEN YEARS.

5651
03:48:01,558 --> 03:48:06,730
AND WE COMBINED EVIDENCE FROM

5652
03:48:06,730 --> 03:48:10,667
MICROSIMULATION STUDIES AND

5653
03:48:10,667 --> 03:48:12,302
OBJECTSAL STUDIES AND EACH YEAR

5654
03:48:12,302 --> 03:48:14,237
FOR THE TEN-YEAR PERIOD I SHOWED

5655
03:48:14,237 --> 03:48:21,511
YOU IN THE TABLE EARLIER WE HAVE

5656
03:48:21,511 --> 03:48:23,246
BASICALLY IN YEAR ONE EVERYBODY

5657
03:48:23,246 --> 03:48:24,781
HAS TAKEN THE MEDICATION FROM

5658
03:48:24,781 --> 03:48:26,183
ONE YEAR OR LESS.

5659
03:48:26,183 --> 03:48:28,151
IN YEAR TWO, YOU HAVE PEOPLE

5660
03:48:28,151 --> 03:48:30,353
THAT HAVE EITHER JUST STARTED

5661
03:48:30,353 --> 03:48:31,454
TAKING THE MEDICATION OR HAVE

5662
03:48:31,454 --> 03:48:33,089
TAKEN IT FOR TWO YEARS.

5663
03:48:33,089 --> 03:48:40,530
AND SO FORTH.

5664
03:48:40,530 --> 03:48:43,533
SO, OBSERVED FOR ESTIMATED

5665
03:48:43,533 --> 03:48:49,005
SAVINGS TAKING INTO ACCOUNT THE

5666
03:48:49,005 --> 03:48:52,142
MIX OF PEOPLE SOME OF WHOM HAVE

5667
03:48:52,142 --> 03:48:53,543
TAKEN THE MEDICATION FOR A VERY

5668
03:48:53,543 --> 03:48:55,745
SHORT PERIOD OF TIME AND SOME

5669
03:48:55,745 --> 03:49:01,918
FOR A VERY LONG TIME. 

5670
03:49:01,918 --> 03:49:04,521
SO MOVING ON TO WHAT NEW

5671
03:49:04,521 --> 03:49:06,089
RESEARCH WOULD BE ESPECIALLY

5672
03:49:06,089 --> 03:49:10,160
USEFUL, I DON'T THINK YOU'LL BE

5673
03:49:10,160 --> 03:49:13,096
SURPRISED BY ANY OF THIS.

5674
03:49:13,096 --> 03:49:23,540
I THINK I WAS ABLE TO SHOW YOU

5675
03:49:23,540 --> 03:49:24,875
AND EXPRESS THERE'S UNCERTAINTY

5676
03:49:24,875 --> 03:49:30,046
IN OUR ESTIMATES AND THERE'S NEW

5677
03:49:30,046 --> 03:49:32,582
INFORMATION COMING OUT DAILY.

5678
03:49:32,582 --> 03:49:33,516
I DON'T HAVE PubMed

5679
03:49:33,516 --> 03:49:37,587
NOTIFICATION BUT I DO HAVE A

5680
03:49:37,587 --> 03:49:38,688
NOTIFICATION FROM GOOGLE

5681
03:49:38,688 --> 03:49:40,357
SCHOLAR, YOU KNOW, EVERY DAY

5682
03:49:40,357 --> 03:49:42,158
THERE ARE A LOT OF NEW STUDIES

5683
03:49:42,158 --> 03:49:44,561
AND NEW INFORMATION COMING UP.

5684
03:49:44,561 --> 03:49:49,065
SO, I THINK THAT WE WOULD BE

5685
03:49:49,065 --> 03:49:50,967
ESPECIALLY INTERESTED IN MORE

5686
03:49:50,967 --> 03:49:54,671
INFORMATION ABOUT USE OF THESE

5687
03:49:54,671 --> 03:49:57,607
MEDICATIONS, TAKEUP RATE AND

5688
03:49:57,607 --> 03:49:59,175
PATIENT ADHERENCE, AND SAVINGS

5689
03:49:59,175 --> 03:50:00,810
FROM IMPROVED HEALTH BASED ON

5690
03:50:00,810 --> 03:50:06,950
DIRECT EVIDENCE WOULD BE

5691
03:50:06,950 --> 03:50:08,785
ESPECIALLY VALUABLE.

5692
03:50:08,785 --> 03:50:12,822
EXPECTATION OF PRICES OF NEW

5693
03:50:12,822 --> 03:50:15,258
OBESITY MEDICATIONS,

5694
03:50:15,258 --> 03:50:16,459
EXPECTATIONS WITH OTHER

5695
03:50:16,459 --> 03:50:17,761
CONDITIONS THESE MEDICATIONS

5696
03:50:17,761 --> 03:50:20,397
WILL BE APPROVED TO TREAT.

5697
03:50:20,397 --> 03:50:23,266
AND ALSO EFFECTS OF WEIGHT LOSS

5698
03:50:23,266 --> 03:50:24,868
ON MORTALITY.

5699
03:50:24,868 --> 03:50:35,445
AND THAT -- THOSE AREAS OF

5700
03:50:35,445 --> 03:50:39,749
RESEARCH CAN BE -- SPECIFIC

5701
03:50:39,749 --> 03:50:44,554
AREAS OF RESEARCH INCLUDE

5702
03:50:44,554 --> 03:50:46,756
SPECIFICALLY FOR THE HEALTH

5703
03:50:46,756 --> 03:50:49,926
SAVINGS, ASSOCIATED WITH HEALTH

5704
03:50:49,926 --> 03:50:52,329
IMPROVEMENT, NOT ONLY SHORT TERM

5705
03:50:52,329 --> 03:50:53,863
BUT ALSO LONG-TERM EFFECTS, WE

5706
03:50:53,863 --> 03:50:57,567
WOULD BE INTERESTED IN EFFECTS

5707
03:50:57,567 --> 03:50:59,903
BY ADHERENCE TIMES, EFFECTS FOR

5708
03:50:59,903 --> 03:51:01,438
DIFFERENT SUBGROUPS, SO

5709
03:51:01,438 --> 03:51:05,375
SUBGROUPS CAN INCLUDE INSURANCE

5710
03:51:05,375 --> 03:51:10,747
COVERAGE, INITIAL BMI, AND AGAIN

5711
03:51:10,747 --> 03:51:11,481
EFFECTS OF MORTALITY AND

5712
03:51:11,481 --> 03:51:13,450
DISABILITY WOULD BE HELPFUL AS

5713
03:51:13,450 --> 03:51:17,087
WOULD ANY INFORMATION ON HOW USE

5714
03:51:17,087 --> 03:51:21,124
OF ANTI-OBESITY MEDICATIONS

5715
03:51:21,124 --> 03:51:23,059
AFFECT EMPLOYMENT.

5716
03:51:23,059 --> 03:51:23,760
THERE'S TYPES OF STUDIES, I

5717
03:51:23,760 --> 03:51:26,696
THINK THIS HAS BEEN DISCUSSED

5718
03:51:26,696 --> 03:51:28,231
BUT RANDOMIZED CONTROLLED TRIALS

5719
03:51:28,231 --> 03:51:30,433
ESPECIALLY ONES WITH LONGER

5720
03:51:30,433 --> 03:51:35,271
FOLLOW-UP PERIODS WOULD BE

5721
03:51:35,271 --> 03:51:37,273
HELPFUL. 

5722
03:51:37,273 --> 03:51:39,609
NATURAL EXPERIMENTS THAT USE

5723
03:51:39,609 --> 03:51:42,345
EXOGENOUS VARIATION IN AOM

5724
03:51:42,345 --> 03:51:43,179
COVERAGE, OUTCOMES WITH AND

5725
03:51:43,179 --> 03:51:45,548
WITHOUT THAT COVERAGE WOULD BE

5726
03:51:45,548 --> 03:51:46,983
HELPFUL, AND OBSERVATIONAL

5727
03:51:46,983 --> 03:51:49,352
STUDIES THAT COMPARE OUTCOMES

5728
03:51:49,352 --> 03:51:51,121
AMONG PEOPLE WHO DID AND DO NOT

5729
03:51:51,121 --> 03:51:52,989
TAKE THESE MEDICATIONS AND ARE

5730
03:51:52,989 --> 03:51:54,758
ABLE TO ADJUST FOR DIFFERENCES

5731
03:51:54,758 --> 03:51:56,192
BETWEEN GROUPS THAT COULD ALSO

5732
03:51:56,192 --> 03:52:00,196
HAVE EFFECTS ON HEALTH AND

5733
03:52:00,196 --> 03:52:01,798
HEALTH CARE SPENDING WOULD BE

5734
03:52:01,798 --> 03:52:03,533
USEFUL AS WELL.

5735
03:52:03,533 --> 03:52:06,136
SO THAT'S THE END OF MY

5736
03:52:06,136 --> 03:52:06,569
PRESENTATION.

5737
03:52:06,569 --> 03:52:06,936
THANK YOU.

5738
03:52:06,936 --> 03:52:10,974
I LOOK FOR WORD TO YOUR

5739
03:52:10,974 --> 03:52:11,241
QUESTIONS.

5740
03:52:11,241 --> 03:52:13,076
>> THANK YOU VERY MUCH.

5741
03:52:13,076 --> 03:52:14,944
APOLOGIES FOR GOING SLIGHTLY OUT

5742
03:52:14,944 --> 03:52:15,478
OF ORDER.

5743
03:52:15,478 --> 03:52:20,483
NEXT SPEANINGER  -- SPEAKER IS

5744
03:52:20,483 --> 03:52:23,119
DAVID HINES, YEARS OF EXPERIENCE

5745
03:52:23,119 --> 03:52:27,257
ADVISING THE STATE OF TENNESSEE,

5746
03:52:27,257 --> 03:52:28,925
NASHVILLE PUBLIC SCHOOLS IN

5747
03:52:28,925 --> 03:52:30,193
NASHVILLE, LED THE ESTABLISHMENT

5748
03:52:30,193 --> 03:52:32,429
OF INTEGRATED HEALTH AND

5749
03:52:32,429 --> 03:52:33,163
WELLNESS FACILITIES, CURRENTLY

5750
03:52:33,163 --> 03:52:35,565
WORKING ON EXPANSION OF

5751
03:52:35,565 --> 03:52:37,233
VALUE-BASED CARE INCLUDING

5752
03:52:37,233 --> 03:52:38,635
BUNDLED PAYMENT PROGRAM FOR

5753
03:52:38,635 --> 03:52:40,437
MEDICAL AND SURGICAL WEIGHT

5754
03:52:40,437 --> 03:52:42,605
LOSS, WILL BE SHARING STATE AND

5755
03:52:42,605 --> 03:52:50,046
PRIVATE PAYER PERSPECTIVE ON

5756
03:52:50,046 --> 03:52:59,889
COVERAGE OF GLP-1 THERAPIES.

5757
03:52:59,889 --> 03:53:02,759
>> IF MR. HINES CAN PUSH
THE

5758
03:53:02,759 --> 03:53:04,094
RIGHT BUTTONS HE WILL.

5759
03:53:04,094 --> 03:53:07,230
LET ME SHARE MY SCREEN.

5760
03:53:07,230 --> 03:53:09,099
YEAH, GET TO THE RIGHT PLACE.

5761
03:53:09,099 --> 03:53:11,201
>> YOU ARE NOT PRESENTING
YET

5762
03:53:11,201 --> 03:53:13,903
BUT WE CAN SEE A PRESENTATION.

5763
03:53:13,903 --> 03:53:18,608
>> OH,  IS IT IN SLIDE
SHOW?

5764
03:53:18,608 --> 03:53:21,678
>>  IT'S NOT IN THE SLIDE
SHOW.

5765
03:53:21,678 --> 03:53:21,978
>> OKAY.

5766
03:53:21,978 --> 03:53:24,013
LET ME SWAP THESE.

5767
03:53:24,013 --> 03:53:25,081
I'M SORRY.

5768
03:53:25,081 --> 03:53:26,716
SOMEBODY ELSE IS MUCH BETTER AT

5769
03:53:26,716 --> 03:53:27,817
THIS THAN I AM.

5770
03:53:27,817 --> 03:53:32,188
>> YOU'RE GOOD AT MANY
OTHER

5771
03:53:32,188 --> 03:53:32,889
THINGS THOUGH.

5772
03:53:32,889 --> 03:53:35,925
>> LET ME SEE.

5773
03:53:35,925 --> 03:53:40,763
>> NOW WE'RE SEEING THE
WRONG

5774
03:53:40,763 --> 03:53:41,331
SCREENS.

5775
03:53:41,331 --> 03:53:42,599
GO TO DISPLAY SETTINGS AND

5776
03:53:42,599 --> 03:53:42,832
SWITCH.

5777
03:53:42,832 --> 03:53:44,801
PERFECT, GOOD TO GO.

5778
03:53:44,801 --> 03:53:45,135
>> GREAT.

5779
03:53:45,135 --> 03:53:45,935
FOLKS, IT'S GREAT TO BE WITH

5780
03:53:45,935 --> 03:53:46,102
YOU.

5781
03:53:46,102 --> 03:53:48,404
I DON'T KNOW HOW I GOT DRUG INTO

5782
03:53:48,404 --> 03:53:50,306
THIS, Y'ALL ARE A HECK OF A LOT

5783
03:53:50,306 --> 03:53:51,174
SMARTER THAN I AM.

5784
03:53:51,174 --> 03:53:53,576
I'VE BEEN IN THE WEEDS FOR

5785
03:53:53,576 --> 03:53:56,813
YEARS, TRYING TO GET THINGS TO

5786
03:53:56,813 --> 03:53:59,082
WORK, WHERE I TAKE CARE OF

5787
03:53:59,082 --> 03:54:02,185
PEOPLE I'M SUPPOSED TO TAKE CARE

5788
03:54:02,185 --> 03:54:03,286
OF.

5789
03:54:03,286 --> 03:54:05,588
METRO NASHVILLE SCHOOLS, I'VE

5790
03:54:05,588 --> 03:54:10,527
GOT 6500 ACTIVE TEACHERS I TAKE

5791
03:54:10,527 --> 03:54:14,998
CARE OF, 3,000-PLUS RETIREES, I

5792
03:54:14,998 --> 03:54:16,799
TAKE CARE OF 18,000 COVERED

5793
03:54:16,799 --> 03:54:17,000
LIVES.

5794
03:54:17,000 --> 03:54:18,067
IT'S A GOOD GROUP.

5795
03:54:18,067 --> 03:54:19,702
IT'S AN INTERESTING GROUP THAT I

5796
03:54:19,702 --> 03:54:19,903
HAVE.

5797
03:54:19,903 --> 03:54:21,571
I TAKE CARE OF TEACHERS.

5798
03:54:21,571 --> 03:54:23,907
I LOOK AT MY EMPLOYEE

5799
03:54:23,907 --> 03:54:24,841
POPULATION, I KNOW THAT

5800
03:54:24,841 --> 03:54:27,143
BASICALLY THEY ARE ALL COLLEGE

5801
03:54:27,143 --> 03:54:28,077
EDUCATED, MOST MASTER'S AND

5802
03:54:28,077 --> 03:54:28,311
BEYOND.

5803
03:54:28,311 --> 03:54:34,484
I KNOW THEY ALL LIVE AND WORK IN

5804
03:54:34,484 --> 03:54:35,485
NASHVILLE, TENNESSEE.

5805
03:54:35,485 --> 03:54:37,253
AND BASICALLY I KNOW I HAVE TO

5806
03:54:37,253 --> 03:54:39,055
HAVE A LONG-TERM VIEW OF WHAT

5807
03:54:39,055 --> 03:54:41,591
GOES ON WITH THIS POPULATION

5808
03:54:41,591 --> 03:54:42,592
BECAUSE WHAT I'VE LEARNED IS

5809
03:54:42,592 --> 03:54:44,794
I'VE LOOKED IN THE DATA OF THIS

5810
03:54:44,794 --> 03:54:47,397
GROUP, IF I HAVE A TEACHER FOR

5811
03:54:47,397 --> 03:54:50,333
ABOUT YEAR 4 OR 5, I'LL PROBABLY

5812
03:54:50,333 --> 03:54:51,901
HAVE THEM INTO RETIREMENT, UNTIL

5813
03:54:51,901 --> 03:54:53,636
THEY ARE NO LONGER WALKING THE

5814
03:54:53,636 --> 03:54:55,271
EARTH WITH US AT THIS POINT.

5815
03:54:55,271 --> 03:54:56,573
TO DO THAT AND UNDERSTAND WHAT'S

5816
03:54:56,573 --> 03:54:58,208
GOING ON WITH THE POPULATION, I

5817
03:54:58,208 --> 03:55:01,177
DO A LOT WITH ON-SITE MEDICAL,

5818
03:55:01,177 --> 03:55:03,346
SINCE 2009.

5819
03:55:03,346 --> 03:55:05,548
I WORK CLOSELY WITH UNIVERSITY

5820
03:55:05,548 --> 03:55:07,717
MEDICAL CENTER HERE, STAFF AND

5821
03:55:07,717 --> 03:55:08,518
MANAGE.

5822
03:55:08,518 --> 03:55:11,221
ALSO GIVE MEDICAL MANAGEMENT AND

5823
03:55:11,221 --> 03:55:13,756
HELPS ME UNDERSTAND WHAT GOES

5824
03:55:13,756 --> 03:55:15,391
INTO THE WORLDS OF MEDICINE, I

5825
03:55:15,391 --> 03:55:16,926
HAVE A MEDICAL DIRECTOR I WORK

5826
03:55:16,926 --> 03:55:17,227
WITH.

5827
03:55:17,227 --> 03:55:19,862
I HAVE A PRETTY ROBUST DATASET

5828
03:55:19,862 --> 03:55:21,965
THAT I DEAL WITH.

5829
03:55:21,965 --> 03:55:23,633
I RECEIVE ALL MY MEDICAL CLAIMS,

5830
03:55:23,633 --> 03:55:25,868
PHARMACY CLAIMS, BUT ON TOP OF

5831
03:55:25,868 --> 03:55:27,203
THAT WILL TAKE A PAYROLL

5832
03:55:27,203 --> 03:55:28,671
EXTRACT, DROP IT OUT THERE SO I

5833
03:55:28,671 --> 03:55:30,707
CAN SEE WHO THESE PEOPLE ARE,

5834
03:55:30,707 --> 03:55:33,009
SEE THE IMPACTS, WHAT WE DO ON

5835
03:55:33,009 --> 03:55:34,410
TIME AND ATTENDANCE, RETENTION.

5836
03:55:34,410 --> 03:55:36,045
I ALSO TAKE RACE AND ETHNICITY,

5837
03:55:36,045 --> 03:55:37,580
DROP IT OUT THERE SO I CAN TRY

5838
03:55:37,580 --> 03:55:39,682
TO UNDERSTAND WHAT'S HAPPENING

5839
03:55:39,682 --> 03:55:39,916
THERE.

5840
03:55:39,916 --> 03:55:41,351
ALSO I UNDERSTAND -- I KNOW

5841
03:55:41,351 --> 03:55:43,286
WHERE THEY WORK AND WHERE THEY

5842
03:55:43,286 --> 03:55:45,288
LIVE AND I KNOW WHERE THEY ARE

5843
03:55:45,288 --> 03:55:47,423
NOT IN AREAS OF HIGH NEED, LOW

5844
03:55:47,423 --> 03:55:47,757
NEED.

5845
03:55:47,757 --> 03:55:51,361
AND ON TOP OF THAT I PULL EMR

5846
03:55:51,361 --> 03:55:58,334
FEEDS FROM OUR MEDICAL CENTERS.

5847
03:55:58,334 --> 03:55:59,202
ALSO LABCORP AND QUEST TO

5848
03:55:59,202 --> 03:56:00,536
UNDERSTAND WHAT'S GOING ON WITH

5849
03:56:00,536 --> 03:56:01,337
THE POPULATION.

5850
03:56:01,337 --> 03:56:03,806
YOU DO A LOT OF WORK TO

5851
03:56:03,806 --> 03:56:04,907
RESEARCH, I UNDERSTAND THE DRUGS

5852
03:56:04,907 --> 03:56:06,809
DRUGS AND IMPACT, I'M TRYING TO

5853
03:56:06,809 --> 03:56:09,379
UNDERSTAND HOW IT IMPACTS MY

5854
03:56:09,379 --> 03:56:10,713
PEOPLE LOCALLY.

5855
03:56:10,713 --> 03:56:13,716
TO MAKE MODIFICATIONS AS I NEED.

5856
03:56:13,716 --> 03:56:17,387
I'M SUPPOSED TO BE TALKING ABOUT

5857
03:56:17,387 --> 03:56:18,688
PRIVATE PAYER PERSPECTIVE, THIS

5858
03:56:18,688 --> 03:56:20,556
IS A PRIVATE PAYER, PEOPLE TELL

5859
03:56:20,556 --> 03:56:24,961
ME I'M  THE ODDTITY.

5860
03:56:24,961 --> 03:56:26,796
MOST PEOPLE DON'T HAVE THE DATA,

5861
03:56:26,796 --> 03:56:30,633
RESEARCH AND SUPPORT, I'VE TAKEN

5862
03:56:30,633 --> 03:56:32,268
A LOT OF APPROACHES

5863
03:56:32,268 --> 03:56:33,703
IN MY AREAS DEALING WITH PRETTY

5864
03:56:33,703 --> 03:56:35,238
NASTY STUFF WHEN IT COMES TO

5865
03:56:35,238 --> 03:56:37,874
HEALTHCARE COST IN THE LAST FEW

5866
03:56:37,874 --> 03:56:38,174
YEARS.

5867
03:56:38,174 --> 03:56:40,376
COMING OUT OF COVID HAS BEEN A

5868
03:56:40,376 --> 03:56:41,411
BIZARRE TIME.

5869
03:56:41,411 --> 03:56:45,415
IF YOU THINK ABOUT THE COST AND

5870
03:56:45,415 --> 03:56:47,383
IMPACTS OF HANDLING GLP-1s,

5871
03:56:47,383 --> 03:56:49,786
THE FRAMEWORK, WHAT ELSE WE'RE

5872
03:56:49,786 --> 03:56:52,188
DEALING WITH, YOU KNOW, WE HAD

5873
03:56:52,188 --> 03:56:53,723
DELAYED CARE, WE THINK SPIKED A

5874
03:56:53,723 --> 03:56:56,225
LOT OF COSTS FOR US.

5875
03:56:56,225 --> 03:56:58,961
ON TOP OF THAT, THERE'S

5876
03:56:58,961 --> 03:57:02,932
SOMETHING THAT'S HAPPENED, WITH

5877
03:57:02,932 --> 03:57:05,768
COVID, THAT MADE PRICES RISE.

5878
03:57:05,768 --> 03:57:09,272
AND BEYOND THAT AS WELL

5879
03:57:09,272 --> 03:57:12,875
PROVIDERS BASICALLY HAD TO

5880
03:57:12,875 --> 03:57:13,209
RE

5881
03:57:13,209 --> 03:57:14,210
RENEGOTIATE AND COME BACK MAKING

5882
03:57:14,210 --> 03:57:16,279
UP FOR LOSSES OUT OF COVID.

5883
03:57:16,279 --> 03:57:19,482
OUR MARKETPLACE HAS BEEN SEEING

5884
03:57:19,482 --> 03:57:21,551
EIGHT, NINE, TEN, ELEVEN PERCENT

5885
03:57:21,551 --> 03:57:23,953
INCREASES, PASSED ON TWO YEARS

5886
03:57:23,953 --> 03:57:25,722
OF PREMIUM INCREASES, HOPING I'M

5887
03:57:25,722 --> 03:57:27,357
FINALLY CLOSING THE GAPS.

5888
03:57:27,357 --> 03:57:30,293
THERE SEEMS TO BE A NEW FORM, A

5889
03:57:30,293 --> 03:57:32,095
LOT DRIVEN BY CATASTROPHIC

5890
03:57:32,095 --> 03:57:32,462
CLAIMS.

5891
03:57:32,462 --> 03:57:35,531
TYPICALLY WHAT WE'VE SEEN IN THE

5892
03:57:35,531 --> 03:57:38,167
MARKETPLACE IS THAT, YOU KNOW,

5893
03:57:38,167 --> 03:57:39,402
WE CONSIDER CATASTROPHIC CLAIM

5894
03:57:39,402 --> 03:57:42,872
THE COMBINED COST GOING OVER

5895
03:57:42,872 --> 03:57:43,406
$100,000.

5896
03:57:43,406 --> 03:57:45,108
REMOVING THAT MARK, IT'S GOING

5897
03:57:45,108 --> 03:57:50,246
TO BE TWO TO TWO-FIFTY, IDENTIFY

5898
03:57:50,246 --> 03:57:52,014
TRUE CATASTROPHIC CLAIM, JUST

5899
03:57:52,014 --> 03:57:54,751
THE VOLUME IS TOO HIGH WHEN WE

5900
03:57:54,751 --> 03:57:55,885
USE THE HUNDRED THOUSAND MARK TO

5901
03:57:55,885 --> 03:57:56,919
UNDERSTAND WHAT'S GOING ON.

5902
03:57:56,919 --> 03:58:00,089
SO IT'S BEEN A TOUGH FEW YEARS,

5903
03:58:00,089 --> 03:58:01,924
HOPEFULLY WE'LL HAVE SOME

5904
03:58:01,924 --> 03:58:03,159
SUNSHINE BUT BASICALLY THE

5905
03:58:03,159 --> 03:58:06,329
QUESTION THAT PEOPLE IN MY

5906
03:58:06,329 --> 03:58:08,398
POSITION, CAN WE AFFORD WHAT TO

5907
03:58:08,398 --> 03:58:11,134
ME LOOKS LIKE ANOTHER 3 TO 4%

5908
03:58:11,134 --> 03:58:13,369
INCREASE WHEN ALREADY DEALING

5909
03:58:13,369 --> 03:58:17,140
WITH AROUND A 10% INCREASE

5910
03:58:17,140 --> 03:58:17,940
WITHOUT GLP-1.

5911
03:58:17,940 --> 03:58:21,110
THE OTHER QUESTION COMES BACK

5912
03:58:21,110 --> 03:58:22,412
INTO THIS STING, TALKING ABOUT

5913
03:58:22,412 --> 03:58:26,048
OUR EXPERIENCE BECAUSE I DID

5914
03:58:26,048 --> 03:58:27,216
TRACK THIS GLP-1s, AND ONE

5915
03:58:27,216 --> 03:58:30,620
GROUPS THAT HAD TO PULL BACK

5916
03:58:30,620 --> 03:58:32,588
FROM IT, BECAUSE BASICALLY WE

5917
03:58:32,588 --> 03:58:33,956
INVESTED TODAY HOPING TO GET

5918
03:58:33,956 --> 03:58:36,559
THAT RETURN BUT THAT RETURN

5919
03:58:36,559 --> 03:58:38,995
COMES FARTHER DOWN FIELD THAT WE

5920
03:58:38,995 --> 03:58:49,472
CAN AFFORD TO HOLD OUT FOR. 

5921
03:58:50,206 --> 03:58:53,643
A LOT OF FOLKS, IF WE OPEN AND

5922
03:58:53,643 --> 03:58:55,645
HAVE GLP-1 COVERAGE, TAKE CARE

5923
03:58:55,645 --> 03:58:57,980
OF AOMs AND WEIGHT LOSS ARE WE

5924
03:58:57,980 --> 03:59:00,249
GOING TO KEEP THESE PEOPLE WE

5925
03:59:00,249 --> 03:59:02,952
SPEND THE MONEY OR ARE WE FIXING

5926
03:59:02,952 --> 03:59:05,288
THEM UP TO GO ELSE THERE AND

5927
03:59:05,288 --> 03:59:14,730
LOSE THE RESOURCE WE INVESTED

5928
03:59:14,730 --> 03:59:15,565
HIGHLY IN.

5929
03:59:15,565 --> 03:59:17,800
SOME THINGS THAT CONCERN US, IS

5930
03:59:17,800 --> 03:59:21,237
THERE EVER AN END TO BEING ON

5931
03:59:21,237 --> 03:59:22,438
GLP-1s IN STUDIES AREN'T

5932
03:59:22,438 --> 03:59:26,042
SHOWING THAT BUT I WONDER ALSO

5933
03:59:26,042 --> 03:59:28,144
THESE STUDIES ARE THEY SHOWING

5934
03:59:28,144 --> 03:59:30,546
GLP-1s IN COMBINATION WITH

5935
03:59:30,546 --> 03:59:32,748
LIFESTYLE PROGRAMS AND COE

5936
03:59:32,748 --> 03:59:34,550
APPROACH, ARE WE LOOKING AT DRUG

5937
03:59:34,550 --> 03:59:36,118
FOR DRUG'S SAKE, OPEN THE DOOR,

5938
03:59:36,118 --> 03:59:37,987
LET PEOPLE GET ON THE DRUGS,

5939
03:59:37,987 --> 03:59:43,025
COMPARE THAT TO SEE IF THEY

5940
03:59:43,025 --> 03:59:45,661
BASICALLY WITHOUT OTHER

5941
03:59:45,661 --> 03:59:46,696
MODIFICATIONS, IS THERE SUCCESS,

5942
03:59:46,696 --> 03:59:48,164
LOOK AT MORE OF A CONTROLLED

5943
03:59:48,164 --> 03:59:51,267
PROGRAM TO WHERE, YOU KNOW, DO

5944
03:59:51,267 --> 03:59:54,670
WE UNDERSTAND IF GLP-1s

5945
03:59:54,670 --> 03:59:56,072
COMBINED WITH VERY ROBUST

5946
03:59:56,072 --> 04:00:06,582
LIFESTYLE PROGRAM WILL GET US

5947
04:00:08,184 --> 04:00:11,287
RESULTS WE NEED. 

5948
04:00:11,287 --> 04:00:12,522
LONG-TERM SIDE EFFECTS NOT

5949
04:00:12,522 --> 04:00:17,994
KNOWN, WE REMEMBER WHEN PHEN-FEN

5950
04:00:17,994 --> 04:00:21,197
WAS ON THE MARKET, WE REMEMBER

5951
04:00:21,197 --> 04:00:21,531
THAT.

5952
04:00:21,531 --> 04:00:24,100
FOR THOSE THAT NEED IT, NOT

5953
04:00:24,100 --> 04:00:26,602
COSMETIC PURPOSES.

5954
04:00:26,602 --> 04:00:30,506
WE SAID WE'RE GOING TO PAY FOR

5955
04:00:30,506 --> 04:00:31,641
ANTI-OBESITY MEDICATION BACK IN

5956
04:00:31,641 --> 04:00:34,710
THE DAY, THE THOUGHT WAS THIS IS

5957
04:00:34,710 --> 04:00:36,579
COSMETIC, BEHAVIORAL ISSUE.

5958
04:00:36,579 --> 04:00:39,048
SCIENCE HAS CHANGED.

5959
04:00:39,048 --> 04:00:40,616
MORE INVOLVED AND MORE ENGAGED

5960
04:00:40,616 --> 04:00:42,685
AT THIS POINT BUT WE STILL WANT

5961
04:00:42,685 --> 04:00:44,787
TO MAKE SURE THAT THOSE THAT

5962
04:00:44,787 --> 04:00:46,188
TRULY NEED IT ARE GETTING IT,

5963
04:00:46,188 --> 04:00:48,157
AND WHEN I LOOK AT MY POPULATION

5964
04:00:48,157 --> 04:00:49,859
ANOTHER THING WE UNDERSTAND IS

5965
04:00:49,859 --> 04:00:52,895
WE GET INTO THE RACE AND

5966
04:00:52,895 --> 04:00:56,399
ETHNICITY, I LOOK AT MY

5967
04:00:56,399 --> 04:00:58,067
PROFILES, LARGE VARIATIONS BY

5968
04:00:58,067 --> 04:00:59,802
RACIAL LINES IN THE WORLD OF

5969
04:00:59,802 --> 04:01:00,636
OBESITY WHICH CONCERNS ME

5970
04:01:00,636 --> 04:01:02,772
BECAUSE WE NEED TO TAKE CARE OF

5971
04:01:02,772 --> 04:01:04,607
FOLKS, TAKE CARE OF FOLKS WELL.

5972
04:01:04,607 --> 04:01:07,910
I'LL LOOK AT MY POPULATION.

5973
04:01:07,910 --> 04:01:09,779
I KNOW THAT ABOUT HALF THAT

5974
04:01:09,779 --> 04:01:11,514
POPULATION LIVES IN AREAS OF

5975
04:01:11,514 --> 04:01:12,281
HIGH NEED.

5976
04:01:12,281 --> 04:01:16,419
I KNOW THAT ON TOP OF THAT, 30%

5977
04:01:16,419 --> 04:01:17,219
GREATER CHANCE YOU'RE A MINORITY

5978
04:01:17,219 --> 04:01:18,621
LIVING IN THAT AREA OF HIGH

5979
04:01:18,621 --> 04:01:18,955
NEED.

5980
04:01:18,955 --> 04:01:23,926
I WANT TO LOOK AT OBESITY IN MY

5981
04:01:23,926 --> 04:01:26,529
POPULATION, 37%, WHAT THAT HID

5982
04:01:26,529 --> 04:01:29,532
IS MY BLACK POPULATION, 55%,

5983
04:01:29,532 --> 04:01:32,201
WHITE AND OTHER POPULATION

5984
04:01:32,201 --> 04:01:33,202
RUNNING LOW 30s.

5985
04:01:33,202 --> 04:01:35,171
THERE'S A DISPARITY THERE THAT I

5986
04:01:35,171 --> 04:01:37,573
THINK WE NEED TO -- YOU TALK

5987
04:01:37,573 --> 04:01:38,774
ABOUT MEETING PEOPLE WHERE THEY

5988
04:01:38,774 --> 04:01:40,943
ARE, TRYING TO HELP OUT, IT'S A

5989
04:01:40,943 --> 04:01:47,750
REAL NEED, A REAL ISSUE.

5990
04:01:47,750 --> 04:01:50,586
ANOTHER FACT IN THE BLACK

5991
04:01:50,586 --> 04:01:51,387
POPULATION, CANCER, LIVING AND

5992
04:01:51,387 --> 04:01:54,991
WORK IN THE AREA OF HIGH NEED.

5993
04:01:54,991 --> 04:01:56,659
I HAVE TO UNDERSTAND SCHOOLS ARE

5994
04:01:56,659 --> 04:01:57,627
WHERE OUR STUDENTS ARE,

5995
04:01:57,627 --> 04:01:59,195
REGARDLESS OF WHAT'S GOING ON,

5996
04:01:59,195 --> 04:02:01,931
IN A VERY URBAN DISTRICT.

5997
04:02:01,931 --> 04:02:04,634
ALSO COMES THE ISSUE OF

5998
04:02:04,634 --> 04:02:05,601
ADHERENCE, WHAT CONCERNS US,

5999
04:02:05,601 --> 04:02:07,603
PAYING FOR A PRESCRIPTION OR TWO

6000
04:02:07,603 --> 04:02:09,138
OR THREE PRESCRIPTIONS, THEY

6001
04:02:09,138 --> 04:02:12,642
JUST FALL OFF OF IT.

6002
04:02:12,642 --> 04:02:14,710
AND DON'T GET ANYWHERE.

6003
04:02:14,710 --> 04:02:15,811
HOW CAN WE ENSURE THE RIGHT

6004
04:02:15,811 --> 04:02:17,980
FOLKS ARE ON IT AND STAY ON IT

6005
04:02:17,980 --> 04:02:19,849
AND NEED TO?

6006
04:02:19,849 --> 04:02:21,384
AND WHAT'S NEXT?

6007
04:02:21,384 --> 04:02:23,486
YOU KNOW, SOONER OR LATER WILL

6008
04:02:23,486 --> 04:02:26,756
BE THE GLP-1 PILL, THAT WILL

6009
04:02:26,756 --> 04:02:29,058
BASICALLY TAKE -- BRING A NEW

6010
04:02:29,058 --> 04:02:31,894
WAVE OF INTEREST FROM FOLKS THAT

6011
04:02:31,894 --> 04:02:34,063
DIDN'T WANT TO GIVE THEMSELVES A

6012
04:02:34,063 --> 04:02:34,263
SHOT.

6013
04:02:34,263 --> 04:02:36,298
ARE WE GOING TO SEE LOWER COST

6014
04:02:36,298 --> 04:02:38,000
WITH THE NEW ONES IN THE

6015
04:02:38,000 --> 04:02:39,435
PIPELINE, WILL WE SEE THINGS

6016
04:02:39,435 --> 04:02:41,203
BETTER THAN THAT?

6017
04:02:41,203 --> 04:02:43,372
ANOTHER THING WE DON'T

6018
04:02:43,372 --> 04:02:47,076
UNDERSTAND IS TRUE COST BECAUSE

6019
04:02:47,076 --> 04:02:49,412
REBATE DOLLARS FLOW BACK THROUGH

6020
04:02:49,412 --> 04:02:52,248
PBMs AND WE DON'T SEE WHAT

6021
04:02:52,248 --> 04:02:53,983
THAT REBATE IS PER DRUG.

6022
04:02:53,983 --> 04:02:56,218
WE JUST KNOW IN GENERAL OUR

6023
04:02:56,218 --> 04:02:58,688
REBATE AMOUNTS ON THE DIFFERENT

6024
04:02:58,688 --> 04:02:59,488
MEDICATIONS.

6025
04:02:59,488 --> 04:03:01,691
AND SO THE TRUE COSTS OF THESE

6026
04:03:01,691 --> 04:03:02,658
MEDICATIONS ARE HIDDEN FROM US

6027
04:03:02,658 --> 04:03:06,495
AND WE SHOULD BE ABLE TO SEE PER

6028
04:03:06,495 --> 04:03:11,100
DRUG, PER LINE, WHAT THE TRUE

6029
04:03:11,100 --> 04:03:11,767
COST IS.

6030
04:03:11,767 --> 04:03:13,769
BUT WITH ALL THOSE CONCERNS AND

6031
04:03:13,769 --> 04:03:15,137
EVERYTHING ELSE, THERE'S STILL

6032
04:03:15,137 --> 04:03:16,706
CHANGES GOING ON WITHIN THE

6033
04:03:16,706 --> 04:03:18,107
INDUSTRY.

6034
04:03:18,107 --> 04:03:22,611
AS YOU CAN SEE, THIS IS A STUDY

6035
04:03:22,611 --> 04:03:25,047
THAT CAME OUT RECENTLY TALKING

6036
04:03:25,047 --> 04:03:26,749
ABOUT EMPLOYER'S PARTICIPATION

6037
04:03:26,749 --> 04:03:30,586
IN GLP-1s, OPENING UP FOR

6038
04:03:30,586 --> 04:03:31,253
ANTI-OBESITY MEDICATION, SMALL

6039
04:03:31,253 --> 04:03:33,789
COMPANIES ARE NOT THERE.

6040
04:03:33,789 --> 04:03:34,790
ONLY 16%.

6041
04:03:34,790 --> 04:03:45,167
A THOUSAND TO FIVE THOUSAND

6042
04:03:45,167 --> 04:03:48,938
WORKERS, ALMOST 25%.

6043
04:03:48,938 --> 04:03:50,239
VERY LITTLE PENETRATION IN THE

6044
04:03:50,239 --> 04:03:51,540
MARKETPLACE BECAUSE A LOT OF

6045
04:03:51,540 --> 04:03:55,711
THINGS WE'RE HEARD, IT'S THE

6046
04:03:55,711 --> 04:03:57,146
COST, AND THE SCARES THE DICKENS

6047
04:03:57,146 --> 04:04:01,484
OUT OF SO MANY OF US.

6048
04:04:01,484 --> 04:04:03,018
SO MUCH HAS ALREADY BEEN

6049
04:04:03,018 --> 04:04:05,521
MENTIONED, EVEN THOSE OF US THAT

6050
04:04:05,521 --> 04:04:06,789
HAVE JUMPED ON THE BANDWAGON

6051
04:04:06,789 --> 04:04:09,125
HAVE HAD TO PULL BACK, MANY OF

6052
04:04:09,125 --> 04:04:09,625
US HAVE.

6053
04:04:09,625 --> 04:04:13,362
AS YOU CAN SEE ON THERE, FROM

6054
04:04:13,362 --> 04:04:16,532
KAISER PERMANENTE, MAKING SOME

6055
04:04:16,532 --> 04:04:20,369
CHANGES, BLUE CROSS, BLUE CROSS

6056
04:04:20,369 --> 04:04:21,670
OF MICHIGAN.

6057
04:04:21,670 --> 04:04:24,740
AND THEN SOME CHANGES EVEN WITH

6058
04:04:24,740 --> 04:04:29,445
REDUCTION IN COVERAGE ON THE FEP

6059
04:04:29,445 --> 04:04:29,678
PROGRAM.

6060
04:04:29,678 --> 04:04:30,212
PEOPLE HAVE PULLED BACK.

6061
04:04:30,212 --> 04:04:31,781
I DON'T THINK THE PUSH IS

6062
04:04:31,781 --> 04:04:37,119
ASTRONG AS -- AS STRONG TO OPEN

6063
04:04:37,119 --> 04:04:39,455
UP, AND COMPANIES INTO GLP-1s

6064
04:04:39,455 --> 04:04:40,956
ARE THE LARGER COMPANIES WHO

6065
04:04:40,956 --> 04:04:47,196
HAVE TO BASICALLY DO MORE TO TRY

6066
04:04:47,196 --> 04:04:49,832
TO BRING IN, YOU KNOW, BATTLE

6067
04:04:49,832 --> 04:04:50,699
FOR EMPLOYEES, THAT COMPETITION

6068
04:04:50,699 --> 04:04:52,034
THAT'S OUT THERE.

6069
04:04:52,034 --> 04:04:56,071
IT'S GOING TO BE MORE YOUR HIGH

6070
04:04:56,071 --> 04:04:59,675
TECH GROUPS, MORE OF THE RICHER

6071
04:04:59,675 --> 04:05:01,644
ORGANIZATIONS AND COMPANIES.

6072
04:05:01,644 --> 04:05:02,778
PUBLIC SECTORS WILL LAG BEHIND.

6073
04:05:02,778 --> 04:05:08,884
ON TOP OF WHAT WE HAVE GOING ON

6074
04:05:08,884 --> 04:05:10,319
WITHIN THE OVERALL COST, PUBLIC

6075
04:05:10,319 --> 04:05:13,889
SECTOR HAS TO WORRY ABOUT BEING

6076
04:05:13,889 --> 04:05:14,723
THE PUBLIC PERSPECTIVE --

6077
04:05:14,723 --> 04:05:16,725
PERCEPTION OF THINGS.

6078
04:05:16,725 --> 04:05:17,726
WHY ARE YOU PROVIDING THIS

6079
04:05:17,726 --> 04:05:18,727
MEDICATION WHEN I CAN'T AFFORD

6080
04:05:18,727 --> 04:05:21,130
TO HAVE IT AND I'M YOUR TAXPAYER

6081
04:05:21,130 --> 04:05:21,664
TYPE SITUATION.

6082
04:05:21,664 --> 04:05:25,067
SO A LITTLE BIT DIFFERENT

6083
04:05:25,067 --> 04:05:27,603
PERSPECTIVE THAT GOES ON.

6084
04:05:27,603 --> 04:05:32,508
IN MY OWN STATE, BEEN INDICATED

6085
04:05:32,508 --> 04:05:33,275
EARLIER, TENNESSEE BENEFIT OPEN

6086
04:05:33,275 --> 04:05:36,812
PLANS OPENED UP AND COVERED

6087
04:05:36,812 --> 04:05:38,848
AOMs IN 2017.

6088
04:05:38,848 --> 04:05:40,382
THEY APPLIED PRIOR AUTHORIZATION

6089
04:05:40,382 --> 04:05:42,251
REQUIREMENT TO IT, AS YOU CAN

6090
04:05:42,251 --> 04:05:42,651
SEE.

6091
04:05:42,651 --> 04:05:46,088
HAVE TO HAVE A CERTAIN BMI, ALSO

6092
04:05:46,088 --> 04:05:47,389
GET MEDICATION INITIALLY

6093
04:05:47,389 --> 04:05:48,924
PARTICIPATE IN A COMPREHENSIVE

6094
04:05:48,924 --> 04:05:52,528
WEIGHT MANAGEMENT PROGRAM FOR

6095
04:05:52,528 --> 04:05:54,930
SIX MONTHS, USE IT WITH REDUCED

6096
04:05:54,930 --> 04:05:55,898
CALORIE AND DIET AND EXERCISE.

6097
04:05:55,898 --> 04:05:58,000
THEN YOU HAVE TO LOSE A CERTAIN

6098
04:05:58,000 --> 04:06:02,271
PERCENTAGE OF BODY WEIGHT TO

6099
04:06:02,271 --> 04:06:03,372
CONTINUE THERAPY.

6100
04:06:03,372 --> 04:06:04,874
FOLKS THAT MANAGE THAT PLAN ARE

6101
04:06:04,874 --> 04:06:05,975
GOOD FRIENDS.

6102
04:06:05,975 --> 04:06:07,409
THEY STRUGGLE WITH THIS.

6103
04:06:07,409 --> 04:06:08,911
THEY TRY TO BASICALLY CONTROL

6104
04:06:08,911 --> 04:06:10,779
THE COST BUT ACTUALLY TAKE CARE

6105
04:06:10,779 --> 04:06:13,649
OF THE FOLKS THAT NEED IT.

6106
04:06:13,649 --> 04:06:16,352
AND I ADMIRE THEM FOR WHAT THEY

6107
04:06:16,352 --> 04:06:16,919
HAVE DONE.

6108
04:06:16,919 --> 04:06:19,288
BUT ONE OF THE CHANGES THAT HAS

6109
04:06:19,288 --> 04:06:22,858
COME ABOUT IS BASICALLY ON THEIR

6110
04:06:22,858 --> 04:06:26,362
CONSUMER-DRIVEN HEALTH PLAN,

6111
04:06:26,362 --> 04:06:29,398
REMOVED AOMs, NOW SUBJECT TO

6112
04:06:29,398 --> 04:06:29,765
DEDUCTIBLE.

6113
04:06:29,765 --> 04:06:31,100
COST-SAVING MOVE ON THEIR BEHALF

6114
04:06:31,100 --> 04:06:33,602
DUE TO COST OF THE DRUG.

6115
04:06:33,602 --> 04:06:36,205
BUT ONE OF THE THINGS THAT FOLKS

6116
04:06:36,205 --> 04:06:37,973
IN MY CHAIR THINK ABOUT IS

6117
04:06:37,973 --> 04:06:40,509
WHAT'S GOING TO HAPPEN ONE DAY

6118
04:06:40,509 --> 04:06:42,778
WHEN AOMs DO HIT THE

6119
04:06:42,778 --> 04:06:44,213
PREVENTIVE DRUG LIST THAT

6120
04:06:44,213 --> 04:06:47,683
APPLIES TO EVERYBODY.

6121
04:06:47,683 --> 04:06:49,051
AND WE'LL BE MANDATED TO CHANGE

6122
04:06:49,051 --> 04:06:50,886
AT THAT POINT, CAN WE BEAR THE

6123
04:06:50,886 --> 04:06:52,521
WEIGHT OF WHAT'S GOING ON,

6124
04:06:52,521 --> 04:06:55,491
SHOULD THAT HAPPEN, WHEN THAT

6125
04:06:55,491 --> 04:06:56,125
HAPPENS.

6126
04:06:56,125 --> 04:06:59,094
IT'S BEEN POINTED OUT THAT

6127
04:06:59,094 --> 04:07:02,031
TENNESSEE HAD LIMITED COVERAGE

6128
04:07:02,031 --> 04:07:04,033
FOR AOMs OR GLP-1s IN

6129
04:07:04,033 --> 04:07:07,636
MEDICAID POPULATION, KIND OF

6130
04:07:07,636 --> 04:07:08,737
INTERESTING.

6131
04:07:08,737 --> 04:07:10,039
THAT POPULATION, PROVIDE AOMs

6132
04:07:10,039 --> 04:07:12,241
FOR THOSE UNDERSTOOD 21, IF OVER

6133
04:07:12,241 --> 04:07:18,514
21 IT'S THE SAME BASIC ROUTINE.

6134
04:07:18,514 --> 04:07:20,683
DIABETICS AND THOSE WITH HEART

6135
04:07:20,683 --> 04:07:21,483
DISEASE.

6136
04:07:21,483 --> 04:07:24,353
THAT'S EVEN IN LIGHT OF 2022,

6137
04:07:24,353 --> 04:07:25,988
TENNESSEE ASSEMBLY HAD A CHRONIC

6138
04:07:25,988 --> 04:07:28,590
WEIGHT MANAGEMENT TASK FORCE

6139
04:07:28,590 --> 04:07:30,125
THAT RECOMMENDED ELIMINATION OF

6140
04:07:30,125 --> 04:07:33,195
THAT RESTRICTION, OPEN UP THE

6141
04:07:33,195 --> 04:07:34,630
GLP-1s TO ALL.

6142
04:07:34,630 --> 04:07:37,366
IT WAS RECOMMENDATION BUT

6143
04:07:37,366 --> 04:07:38,834
DEFINITELY WASN'T ACTED ON.

6144
04:07:38,834 --> 04:07:46,108
AS NOTED RECENTLY IN THE NEWS

6145
04:07:46,108 --> 04:07:48,143
THAT OUR TENNCARE SUBMITTED

6146
04:07:48,143 --> 04:07:48,777
BUDGET REQUEST FOR $118 MILLION

6147
04:07:48,777 --> 04:07:56,518
TO COVER THE COST OF GLP-1s

6148
04:07:56,518 --> 04:07:56,885
ALONE.

6149
04:07:56,885 --> 04:07:58,454
OUR STORY, I'VE GOT DATA, I LOVE

6150
04:07:58,454 --> 04:08:00,990
MY DATA AND KEEP IT WITH UP.

6151
04:08:00,990 --> 04:08:03,959
WE'VE BEEN WORKING IN THIS AREA

6152
04:08:03,959 --> 04:08:04,259
OF DIABETES.

6153
04:08:04,259 --> 04:08:06,228
THERE'S A LOT OF MONEY, ALL YOU

6154
04:08:06,228 --> 04:08:09,198
FOLKS KNOW, SPENT ON DIABETICS,

6155
04:08:09,198 --> 04:08:11,066
NOT NECESSARILY THE COST OF

6156
04:08:11,066 --> 04:08:12,901
DIABETES ALONE BUT TOTAL

6157
04:08:12,901 --> 04:08:14,770
HEALTHCARE SPEND WITH

6158
04:08:14,770 --> 04:08:15,871
COMORBIDITIES WITHIN THAT

6159
04:08:15,871 --> 04:08:16,305
POPULATION.

6160
04:08:16,305 --> 04:08:18,607
WHAT WE'VE NOTICED IN OUR

6161
04:08:18,607 --> 04:08:20,576
POPULATION, AND WORK WE'VE DONE,

6162
04:08:20,576 --> 04:08:23,078
OVER THE YEARS, WE'VE BEEN

6163
04:08:23,078 --> 04:08:24,613
KEEPING OVERALL TOTAL HEALTH

6164
04:08:24,613 --> 04:08:28,217
CARE FOR DIABETIC POPULATION

6165
04:08:28,217 --> 04:08:29,785
RELATIVELY FLAT.

6166
04:08:29,785 --> 04:08:31,754
LOOKING INTO DIABETIC SPENDS

6167
04:08:31,754 --> 04:08:32,621
SPECIFICALLY WHAT'S OF INTEREST

6168
04:08:32,621 --> 04:08:37,993
IS THIS ISSUE THE TOP PART IS

6169
04:08:37,993 --> 04:08:40,529
GLP-1 UTILIZATION, OF THAT

6170
04:08:40,529 --> 04:08:43,032
POPULATION, ORANGE, ALL OVER

6171
04:08:43,032 --> 04:08:45,667
PHARMACY, BLUE BAND IS MEDICAL.

6172
04:08:45,667 --> 04:08:47,936
THE LINE IS INCREASE IN

6173
04:08:47,936 --> 04:08:49,605
CONTINUOUS GLUCOSE MONITORING

6174
04:08:49,605 --> 04:08:51,040
UTILIZATION IN THE POPULATION.

6175
04:08:51,040 --> 04:08:55,844
WHAT WE'VE NOTICED IS AS THE

6176
04:08:55,844 --> 04:08:56,945
GLP-1 UTILIZATION HAS INCREASED

6177
04:08:56,945 --> 04:08:59,715
TO OFFSET THE MAJORITY OF THAT

6178
04:08:59,715 --> 04:09:02,418
INCREASE, WITH DECREASES IN

6179
04:09:02,418 --> 04:09:03,619
OTHER PHARMACY SPEND AND MEDICAL

6180
04:09:03,619 --> 04:09:04,953
SPEND OF THAT POPULATION.

6181
04:09:04,953 --> 04:09:06,922
LIKE I SAY, OVERALL WE'RE

6182
04:09:06,922 --> 04:09:08,791
KEEPING IT STEADY.

6183
04:09:08,791 --> 04:09:10,526
WHAT'S OF INTEREST, LOOKING

6184
04:09:10,526 --> 04:09:12,161
INSIDE THE NUMBERS, DIABETIC

6185
04:09:12,161 --> 04:09:14,029
POPULATION, LOOKED AT INSULIN

6186
04:09:14,029 --> 04:09:14,329
USE.

6187
04:09:14,329 --> 04:09:16,765
WE'VE SEEN REDUCTION IN VOLUME

6188
04:09:16,765 --> 04:09:18,834
OF INSULIN USE THAT COMES ABOUT

6189
04:09:18,834 --> 04:09:20,602
BY BASICALLY NUMBER OF UNITS AND

6190
04:09:20,602 --> 04:09:22,671
NUMBER OF PATIENTS SO WE'RE

6191
04:09:22,671 --> 04:09:25,174
SEEING A DOWNWARD TREND IN

6192
04:09:25,174 --> 04:09:26,942
DIABETICS, IN OUR POPULATION.

6193
04:09:26,942 --> 04:09:28,444
HOWEVER, THE OTHER THING TRYING

6194
04:09:28,444 --> 04:09:30,312
TO PUSH BACK THE OTHER DIRECTION

6195
04:09:30,312 --> 04:09:33,282
IS WE'RE SEEING INCREASED NUMBER

6196
04:09:33,282 --> 04:09:35,684
OF PEOPLE BEING DIAGNOSED WITH

6197
04:09:35,684 --> 04:09:38,654
DIABETES AND THEY ARE GOING FROM

6198
04:09:38,654 --> 04:09:41,056
GOING ALMOST DIRECTLY TO

6199
04:09:41,056 --> 04:09:43,792
GLP-1s NOW, SO THE LAG BETWEEN

6200
04:09:43,792 --> 04:09:50,566
DIAGNOSIS AND APPLICATION OF

6201
04:09:50,566 --> 04:09:52,301
GLP-1s HAS BEEN REDUCED.

6202
04:09:52,301 --> 04:09:53,635
I MENTIONED WE WERE THE ONES

6203
04:09:53,635 --> 04:09:56,371
THAT TRIED THIS AND HAD TO STOP.

6204
04:09:56,371 --> 04:09:58,006
I'VE BEEN WORKING WITH THE

6205
04:09:58,006 --> 04:10:00,843
MEDICAL CENTER FOR YEARS DOING

6206
04:10:00,843 --> 04:10:02,711
DIFFERENT VALUE-BASED BUNDLES,

6207
04:10:02,711 --> 04:10:04,580
STARTING WITH MATERNITY.

6208
04:10:04,580 --> 04:10:06,648
WE'VE MOVED INTO ONCOLOGY

6209
04:10:06,648 --> 04:10:07,749
PATHWAYS AT THIS POINT.

6210
04:10:07,749 --> 04:10:10,486
A FEW YEARS AGO WE STARTED WITH

6211
04:10:10,486 --> 04:10:15,958
OUR FIRST WEIGHT LOSS BUNDLE, A

6212
04:10:15,958 --> 04:10:16,625
BARIATRIC SURGERY, AS LONG AS

6213
04:10:16,625 --> 04:10:20,562
YOU WENTZ TO A CENTER OF

6214
04:10:20,562 --> 04:10:22,431
EXCELLENCE, ALL SERVICES AT NO

6215
04:10:22,431 --> 04:10:25,767
CHARGE, SO GIVING AWAY BARIATRIC

6216
04:10:25,767 --> 04:10:26,001
SURGERY.

6217
04:10:26,001 --> 04:10:28,137
I TOLD THE FOLKS THAT RAN THAT

6218
04:10:28,137 --> 04:10:30,205
PROGRAM IF I'M GOING TO CUT

6219
04:10:30,205 --> 04:10:31,773
SOMEBODY TO LOSE WEIGHT I'LL PAY

6220
04:10:31,773 --> 04:10:34,143
THEM TO TAKE A PILL OR SHOT AS

6221
04:10:34,143 --> 04:10:34,676
WELL.

6222
04:10:34,676 --> 04:10:37,312
I WAS LOOKING AT GLP-1s AND

6223
04:10:37,312 --> 04:10:38,313
POTENTIAL OUTCOMES THAT WOULD

6224
04:10:38,313 --> 04:10:39,882
COME, WE DID WHAT YOU FOLKS

6225
04:10:39,882 --> 04:10:41,083
TALKED ABOUT, LOOKED AT RESULTS

6226
04:10:41,083 --> 04:10:43,819
THAT CAME AROUND ON THE

6227
04:10:43,819 --> 04:10:45,521
BARIATRIC SURGERY, AND RETURN ON

6228
04:10:45,521 --> 04:10:47,656
INVESTMENT THAT COULD COME FROM

6229
04:10:47,656 --> 04:10:49,191
THE WEIGHT LOSS AND PERCENTAGE

6230
04:10:49,191 --> 04:10:53,128
OF WEIGHT LOSS, USED THAT AS

6231
04:10:53,128 --> 04:10:54,163
VALIDATION OF THE POTENTIAL

6232
04:10:54,163 --> 04:11:00,068
COST, SAVINGS OF THAT PROGRAM.

6233
04:11:00,068 --> 04:11:01,937
WE LAUNCH THE MEDICAL WEIGHT

6234
04:11:01,937 --> 04:11:07,109
LOSS SURGERY. 

6235
04:11:07,109 --> 04:11:08,210
I KEPT ANTI-OBESITY SURGERY

6236
04:11:08,210 --> 04:11:08,944
COVERED, OPENED ON THE MEDICAL

6237
04:11:08,944 --> 04:11:12,247
SIDE AS PART OF THE PROGRAM, RAN

6238
04:11:12,247 --> 04:11:15,284
IT THROUGH OUR OWN CLIENT

6239
04:11:15,284 --> 04:11:16,485
SPECIFIC NETWORK.

6240
04:11:16,485 --> 04:11:18,187
RESULTS WERE GREAT.

6241
04:11:18,187 --> 04:11:20,255
PEOPLE WERE LOSING WEIGHT, BLOOD

6242
04:11:20,255 --> 04:11:22,791
PRESSURE DROPPED, GLUCOSE

6243
04:11:22,791 --> 04:11:25,861
DROPPED, A1c DROPPED, LDL

6244
04:11:25,861 --> 04:11:27,396
DROPPED, GOOD RESULTS.

6245
04:11:27,396 --> 04:11:31,333
AS WE LAUNCHED THE PROGRAM

6246
04:11:31,333 --> 04:11:37,272
INITIALLY, WE HAD BASICALLY

6247
04:11:37,272 --> 04:11:39,541
LIMITATIONS IN THE MARKETPLACE

6248
04:11:39,541 --> 04:11:40,976
ON GETTING THE GLP-1 -- THE

6249
04:11:40,976 --> 04:11:42,511
MARKET WAS TIGHT.

6250
04:11:42,511 --> 04:11:44,146
SUPPLY WAS NOT MEETING DEMAND.

6251
04:11:44,146 --> 04:11:48,951
IT PUT ITS OWN TYPE OF CAP ON

6252
04:11:48,951 --> 04:11:49,952
UTILIZATION, AS THE MARKET GOT

6253
04:11:49,952 --> 04:11:55,958
BETTER AND FLOW OF GLP-1s GOT

6254
04:11:55,958 --> 04:11:56,825
STRONGER VOLUME INCREASED.

6255
04:11:56,825 --> 04:11:59,595
AT THE ENDS OF THE DAY, HALF A

6256
04:11:59,595 --> 04:12:01,330
MILLION A MONTH, AT THE ENDS OF

6257
04:12:01,330 --> 04:12:03,232
THE DAY, ON THAT PROGRAM.

6258
04:12:03,232 --> 04:12:08,237
THE OTHER GROUP ON THAT PROGRAM

6259
04:12:08,237 --> 04:12:11,306
BUNDLE WAS THE MEDICAL CENTER

6260
04:12:11,306 --> 04:12:12,608
ITSELF FOR THEIR EMPLOYEES.

6261
04:12:12,608 --> 04:12:14,576
I HAD BASICALLY SET UP THIS

6262
04:12:14,576 --> 04:12:17,212
FIRST INITIAL CAP THAT CAME BY

6263
04:12:17,212 --> 04:12:20,182
UTILIZATIONI ACTUALLY CONTROLLED

6264
04:12:20,182 --> 04:12:21,149
THE SPIGOT, I COULD CONTROL THE

6265
04:12:21,149 --> 04:12:24,553
COST BUT THEY DID NOT.

6266
04:12:24,553 --> 04:12:25,754
THEY ENDED UP BASICALLY

6267
04:12:25,754 --> 04:12:28,056
INVESTING A LOT MORE IN THE

6268
04:12:28,056 --> 04:12:29,691
BUNDLE THAN I DID TYPE

6269
04:12:29,691 --> 04:12:31,326
SITUATION, AND CAME TO THE POINT

6270
04:12:31,326 --> 04:12:32,527
FINANCIALLY THEY BASICALLY COULD

6271
04:12:32,527 --> 04:12:34,763
NOT AFFORD TO DO IT ANYMORE.

6272
04:12:34,763 --> 04:12:37,332
SO THEY DECIDED TO SHUT DOWN THE

6273
04:12:37,332 --> 04:12:38,066
PROGRAM, BASICALLY IF THEY ARE

6274
04:12:38,066 --> 04:12:40,335
NOT GOING TO DO IT FOR

6275
04:12:40,335 --> 04:12:41,536
THEMSELVES ARE NOT GOING TO DO

6276
04:12:41,536 --> 04:12:43,505
IT FOR ANYONE ELSE.

6277
04:12:43,505 --> 04:12:45,907
AND I ARGUED WITH THEM, FUSSED A

6278
04:12:45,907 --> 04:12:48,010
LITTLE BIT, REALITY I KNEW I

6279
04:12:48,010 --> 04:12:51,280
COULDN'T AFFORD IT EITHER.

6280
04:12:51,280 --> 04:12:54,349
BUT IT'S WHAT I'VE DONE AT THIS

6281
04:12:54,349 --> 04:12:57,185
POINT, RAN THIS PROGRAM FOR TWO

6282
04:12:57,185 --> 04:12:59,187
YEARS, 18 MONTHS IN DURATION.

6283
04:12:59,187 --> 04:13:02,024
WE HAD 80% RETENTION AT THAT

6284
04:13:02,024 --> 04:13:03,258
18-MONTH PERIOD.

6285
04:13:03,258 --> 04:13:06,161
WE STILL HAVE PEOPLE IN THE

6286
04:13:06,161 --> 04:13:08,664
PROGRAM BECAUSE IT TWILIGHTED IN

6287
04:13:08,664 --> 04:13:10,532
DECEMBER, SO WE FRONT-LOADED

6288
04:13:10,532 --> 04:13:11,633
PAYMENT ON THE PROGRAM SO

6289
04:13:11,633 --> 04:13:13,168
ANYBODY THAT MADE IT IN DISEASE

6290
04:13:13,168 --> 04:13:18,974
HAD THE OF -- IN DECEMBER HAD

6291
04:13:18,974 --> 04:13:21,510
THE FULL 18 MONTHS OF COVERAGE,

6292
04:13:21,510 --> 04:13:22,711
FIRST WAS WORKING YOURSELF UP,

6293
04:13:22,711 --> 04:13:25,314
LATTER PART WAS HOW DO YOU

6294
04:13:25,314 --> 04:13:27,616
REDUCE YOUR DEPENDENCY ON IT.

6295
04:13:27,616 --> 04:13:36,258
AND WE HAD GOOD RESULTS,

6296
04:13:36,258 --> 04:13:40,962
OVERALL, IN THE APPLICATION.

6297
04:13:40,962 --> 04:13:44,032
22.5, WHAT'S GOING ON, NOT

6298
04:13:44,032 --> 04:13:47,769
GETTING ROI QUICK ENOUGH HAD TO

6299
04:13:47,769 --> 04:13:48,203
TERMINATE.

6300
04:13:48,203 --> 04:13:52,040
POST-PROGRAM THOSE THAT

6301
04:13:52,040 --> 04:13:57,145
GRADUATED OUT 60 OF PATIENTS

6302
04:13:57,145 --> 04:14:00,015
HELD WEIGHT STABLE, 24% AVERAGE

6303
04:14:00,015 --> 04:14:04,386
WEIGHT LOSS RAN 23 POUNDS

6304
04:14:04,386 --> 04:14:08,223
OVERALL WEIGHT FOR THE

6305
04:14:08,223 --> 04:14:10,292
POPULATION INCREASED BY 2.8 SO

6306
04:14:10,292 --> 04:14:12,894
WE'VE SEEN SUSTAINING EVEN

6307
04:14:12,894 --> 04:14:15,163
WITHOUT GLP-1s IN THE PROGRAM

6308
04:14:15,163 --> 04:14:19,401
AND WE'VE SEEN EVEN BETTER

6309
04:14:19,401 --> 04:14:21,703
IMPROVEMENTS FOR THE DIABETIC

6310
04:14:21,703 --> 04:14:21,903
GROUP.

6311
04:14:21,903 --> 04:14:22,404
GOOD PARTICIPATION.

6312
04:14:22,404 --> 04:14:25,173
ANOTHER THING OF NOTE THAT WE

6313
04:14:25,173 --> 04:14:28,510
FOUND WE RAN A GOOD HEALTH

6314
04:14:28,510 --> 04:14:29,478
PROGRAM, BASICALLY

6315
04:14:29,478 --> 04:14:31,012
GASTROINTESTINAL HEALTH PROGRAM,

6316
04:14:31,012 --> 04:14:33,415
HIGH OVERLAP OF THOSE WITHIN THE

6317
04:14:33,415 --> 04:14:34,316
MEDICAL WEIGHT LOSS PROGRAM AND

6318
04:14:34,316 --> 04:14:36,585
G.I. PROGRAM WHICH HELPED US A

6319
04:14:36,585 --> 04:14:40,122
LOT WITH OUR RETENTION NUMBERS

6320
04:14:40,122 --> 04:14:40,589
PROBABLY.

6321
04:14:40,589 --> 04:14:42,124
SO, WHAT ARE THE KEY KNOWLEDGE

6322
04:14:42,124 --> 04:14:48,864
GAPS THAT NEED TO BE ADDRESSED? 

6323
04:14:48,864 --> 04:14:49,965
COVERAGE ACCESS TO GLP-1

6324
04:14:49,965 --> 04:14:53,468
THERAPY, YOU KNOW, WE BELIEVE IN

6325
04:14:53,468 --> 04:14:56,004
THE VALUE OF GLP-1s, YOU CAN'T

6326
04:14:56,004 --> 04:14:57,839
DENY IT, YOU SEE THE RESULTS,

6327
04:14:57,839 --> 04:15:01,476
PEOPLE LOSING WEIGHT AND THINGS

6328
04:15:01,476 --> 04:15:01,977
IMPROVE.

6329
04:15:01,977 --> 04:15:04,079
WHEN IT COMES TO OBESITY,

6330
04:15:04,079 --> 04:15:06,281
THERE'S NOT MANY OF US BASICALLY

6331
04:15:06,281 --> 04:15:08,350
ARGUING OBESITY IS NOT A

6332
04:15:08,350 --> 04:15:08,583
DISEASE.

6333
04:15:08,583 --> 04:15:10,118
WE BELIEVE IT IS A DISEASE AND

6334
04:15:10,118 --> 04:15:11,753
SHOULD BE TREATED AS SUCH AND

6335
04:15:11,753 --> 04:15:14,389
JUST IRRITATES THE HELL OUT OF

6336
04:15:14,389 --> 04:15:16,258
ME, I'VE GOT A DISEASE AND A

6337
04:15:16,258 --> 04:15:20,128
RELATIVE CURE BUT I CAN'T AFFORD

6338
04:15:20,128 --> 04:15:21,630
TO APPLY IT.

6339
04:15:21,630 --> 04:15:23,298
WE'VE RUN INTO DILEMMAS

6340
04:15:23,298 --> 04:15:25,467
SOMETIMES, A LOT OF TIMES AN

6341
04:15:25,467 --> 04:15:28,637
AREA OF FERTILITY AND FERTILITY

6342
04:15:28,637 --> 04:15:29,104
BENEFITS.

6343
04:15:29,104 --> 04:15:30,872
PRECURSOR TO THIS TYPE OF

6344
04:15:30,872 --> 04:15:32,974
SITUATION. 

6345
04:15:32,974 --> 04:15:35,944
THE FACT IF YOU LOOK AT STANDARD

6346
04:15:35,944 --> 04:15:36,778
FERTILITY COVERAGE, PAY TO

6347
04:15:36,778 --> 04:15:38,613
DIAGNOSE, TO FIND OUT WHY THEY

6348
04:15:38,613 --> 04:15:40,749
CAN'T HAVE A BABY BUT DON'T PAY

6349
04:15:40,749 --> 04:15:41,483
TO CREATE IT.

6350
04:15:41,483 --> 04:15:44,553
A FEW OF US STEPPED OUT MORE AND

6351
04:15:44,553 --> 04:15:46,154
MORE TO ADD FERTILITY COVERAGE,

6352
04:15:46,154 --> 04:15:49,391
TO HELP PEOPLE HAVE A

6353
04:15:49,391 --> 04:15:50,258
FAMILY-TYPE SITUATION.

6354
04:15:50,258 --> 04:15:51,927
THOSE THAT HAVE NOT DONE THAT,

6355
04:15:51,927 --> 04:15:57,265
IT'S BEEN THE SAME THING, COST

6356
04:15:57,265 --> 04:15:57,666
ISSUES.

6357
04:15:57,666 --> 04:15:59,801
SOME DO STRUGGLE TO UNDERSTAND

6358
04:15:59,801 --> 04:16:01,203
SOME PEOPLE CAN'T SUCCEED

6359
04:16:01,203 --> 04:16:02,537
WITHOUT MEDICAL AND SURGICAL

6360
04:16:02,537 --> 04:16:03,071
INTERVENTIONS.

6361
04:16:03,071 --> 04:16:06,908
ONE OF THE THINGS WE NOTICE IS

6362
04:16:06,908 --> 04:16:10,111
WHAT HAPPENS ON THAT BMI CHART,

6363
04:16:10,111 --> 04:16:14,149
YOU CAN BASICALLY NEED TO

6364
04:16:14,149 --> 04:16:15,350
UPDATE, MORE AGGRESSIVE TYPE

6365
04:16:15,350 --> 04:16:15,784
SITUATION.

6366
04:16:15,784 --> 04:16:19,221
USED TO BE EVERYBODY THOUGHT IT

6367
04:16:19,221 --> 04:16:19,588
WAS BEHAVIORAL.

6368
04:16:19,588 --> 04:16:21,556
LIKE I SAID, WITH THE NEW

6369
04:16:21,556 --> 04:16:26,528
KNOWLEDGE, THERE'S MORE AND MORE

6370
04:16:26,528 --> 04:16:30,232
ACCEPTANCE IT GOES BEYOND.

6371
04:16:30,232 --> 04:16:32,534
BASICALLY WE NEED LOWER PRICES

6372
04:16:32,534 --> 04:16:33,535
AND INTEGRATED WEIGHT LOSS

6373
04:16:33,535 --> 04:16:34,002
PROGRAM.

6374
04:16:34,002 --> 04:16:36,571
I DON'T WANT TO OPEN UP THROUGH

6375
04:16:36,571 --> 04:16:38,006
MY PHARMACY BENEFIT WITHOUT IT

6376
04:16:38,006 --> 04:16:38,874
BEING ATTACHED TO SOMETHING.

6377
04:16:38,874 --> 04:16:40,942
WE WANT TO HELP PEOPLE SUCCEED,

6378
04:16:40,942 --> 04:16:42,611
NOT JUST TAKE A MEDICINE AND

6379
04:16:42,611 --> 04:16:45,413
WHEN IT DOESN'T WORK OR THEY

6380
04:16:45,413 --> 04:16:46,748
HAVE ISSUES, STOP TAKING

6381
04:16:46,748 --> 04:16:47,148
MEDICINE.

6382
04:16:47,148 --> 04:16:47,716
EVERYTHING SHOULD BE TIED

6383
04:16:47,716 --> 04:16:49,718
TOGETHER WITH HOW YOU CAN MODIFY

6384
04:16:49,718 --> 04:16:51,653
YOUR LIFESTYLE AND BASICALLY

6385
04:16:51,653 --> 04:16:57,259
HAVE THESE DRUGS TO HELP YOU.

6386
04:16:57,259 --> 04:17:00,228
AND BASICALLY NEED MEANS TO

6387
04:17:00,228 --> 04:17:01,429
ENHANCE ADHERENCE, BETTER

6388
04:17:01,429 --> 04:17:03,732
SCREENING, SHORTER TIMELINE FROM

6389
04:17:03,732 --> 04:17:04,799
INVESTMENT TO RETURN.

6390
04:17:04,799 --> 04:17:06,668
ANOTHER ONE OF THE HATS I WEAR

6391
04:17:06,668 --> 04:17:09,604
HEAD UP THE TENNESSEE COALITION,

6392
04:17:09,604 --> 04:17:10,539
BASE COALITION OF HEALTH, HEALTH

6393
04:17:10,539 --> 04:17:13,141
CARE TENNESSEE, PART OF THE

6394
04:17:13,141 --> 04:17:14,676
NATIONAL ALLIANCE OF PURCHASER

6395
04:17:14,676 --> 04:17:16,111
COALITIONS, ALL THESE COALITIONS

6396
04:17:16,111 --> 04:17:19,948
FROM THE MIDWEST TO HOUSTON, TO

6397
04:17:19,948 --> 04:17:20,715
ST. LOUIS, ET CETERA, BASICALLY

6398
04:17:20,715 --> 04:17:22,884
ARE PART OF THIS LARGER

6399
04:17:22,884 --> 04:17:25,387
COALITION ACTIVITY THAT WE HAVE.

6400
04:17:25,387 --> 04:17:27,188
COALITION CAME OUT WITH

6401
04:17:27,188 --> 04:17:29,024
BASICALLY A POSITION STATEMENT,

6402
04:17:29,024 --> 04:17:31,326
WHEN IT CAME TO OBESITY AND

6403
04:17:31,326 --> 04:17:33,962
WEIGHT LOSS, WHICH WAS WORTHY.

6404
04:17:33,962 --> 04:17:36,031
BASICALLY POINTS OUT OR

6405
04:17:36,031 --> 04:17:39,267
ACKNOWLEDGES THAT OBESITY IS

6406
04:17:39,267 --> 04:17:39,768
COMPLEX, MULTI-FACETED,

6407
04:17:39,768 --> 04:17:43,805
AFFECTING MORE THAN 40% OF THE

6408
04:17:43,805 --> 04:17:45,073
POPULATION.

6409
04:17:45,073 --> 04:17:46,541
ALL THESE DISEASES, RECOGNIZING

6410
04:17:46,541 --> 04:17:48,743
MOST EMPLOYERS AND MOST ARE

6411
04:17:48,743 --> 04:17:50,078
COMMITTED TO A WHOLE PERSON

6412
04:17:50,078 --> 04:17:51,813
HEALTH APPROACH FOR EMPLOYEES

6413
04:17:51,813 --> 04:17:53,882
AND THEIR FAMILIES, INCLUDES

6414
04:17:53,882 --> 04:17:59,154
OPTIMIZATION OF HEALTHCARE

6415
04:17:59,154 --> 04:18:00,889
RESOURCES, ACKNOWLEDGE URGENCY

6416
04:18:00,889 --> 04:18:02,757
AND LONG-HELD STIGMAS AND BIASES

6417
04:18:02,757 --> 04:18:03,959
ASSOCIATED WITH IT.

6418
04:18:03,959 --> 04:18:05,927
AND THAT WE SHOULD CONSIDER THE

6419
04:18:05,927 --> 04:18:06,695
FULL SPECTRUM.

6420
04:18:06,695 --> 04:18:10,298
WE'D LOVE TO CONSIDER THE FULL

6421
04:18:10,298 --> 04:18:12,968
SPECTRUM FROM LIFESTYLE TO OTHER

6422
04:18:12,968 --> 04:18:15,637
OBESITY MANAGEMENT STRATEGIES TO

6423
04:18:15,637 --> 04:18:17,505
GLP-1s TYPE SITUATION.

6424
04:18:17,505 --> 04:18:19,941
WE DO KNOW THAT TRADITIONAL

6425
04:18:19,941 --> 04:18:23,878
APPROACHES HAVE FALLEN SHORT.

6426
04:18:23,878 --> 04:18:26,281
AND THESE -- BASICALLY WHAT WE

6427
04:18:26,281 --> 04:18:27,916
BELIEVE IS THIS ENGAGING THROUGH

6428
04:18:27,916 --> 04:18:30,118
OBESITY SCIENCE, I'M GLAD YOU

6429
04:18:30,118 --> 04:18:31,419
FOLKS ARE PUSHING THAT FORWARD,

6430
04:18:31,419 --> 04:18:34,823
BUT WE ALSO HAVE TO DESIGN FOR

6431
04:18:34,823 --> 04:18:35,523
AFFORDABLE, EQUITABLE,

6432
04:18:35,523 --> 04:18:36,224
SUSTAINABLE IMPACT.

6433
04:18:36,224 --> 04:18:39,060
WE'VE GOT TO AFFORD THE ANSWER,

6434
04:18:39,060 --> 04:18:40,495
AFFORD THE CURE.

6435
04:18:40,495 --> 04:18:42,364
WE BELIEVE IN PERSONALIZED

6436
04:18:42,364 --> 04:18:43,798
SHARED DECISION-MAKING AND

6437
04:18:43,798 --> 04:18:44,265
RESPONSIBILITY.

6438
04:18:44,265 --> 04:18:47,602
YOU CAN'T JUST -- IT'S NOT ONE

6439
04:18:47,602 --> 04:18:49,270
SIZE FITS ALL.

6440
04:18:49,270 --> 04:18:50,772
WE WATCHED OBESITY PROGRAMS IN

6441
04:18:50,772 --> 04:18:53,074
OUR ORGANIZATION, THROUGH THE

6442
04:18:53,074 --> 04:18:54,409
NET-WIDE UNDERSTANDING ONE THING

6443
04:18:54,409 --> 04:18:57,679
A PERSON MIGHT REACT TO ONE

6444
04:18:57,679 --> 04:18:58,647
PROGRAM, ANOTHER PERSON WON'T,

6445
04:18:58,647 --> 04:19:00,515
BUT THEY WILL REACT TO SOMETHING

6446
04:19:00,515 --> 04:19:00,849
ELSE.

6447
04:19:00,849 --> 04:19:04,019
OVERALL WE HAVE TO BE BETTER

6448
04:19:04,019 --> 04:19:05,987
INTO INTEGRATING CARE INTO THIS

6449
04:19:05,987 --> 04:19:07,622
CULTURE OF HEALTH AND

6450
04:19:07,622 --> 04:19:09,591
WELL-BEING, BASICALLY IT WILL

6451
04:19:09,591 --> 04:19:12,460
HELP US ALL WITH BOTTOM LINE AND

6452
04:19:12,460 --> 04:19:13,695
PRODUCTIVITY.

6453
04:19:13,695 --> 04:19:15,397
THAT IS IT. 

6454
04:19:15,397 --> 04:19:16,831
THANK YOU FOLKS.

6455
04:19:16,831 --> 04:19:17,699
>> GREAT.

6456
04:19:17,699 --> 04:19:19,567
THANK YOU SO MUCH.

6457
04:19:19,567 --> 04:19:21,936
I ASK FOR ALL THE SPEAKERS TO

6458
04:19:21,936 --> 04:19:24,272
COME ON THE CAMERA.

6459
04:19:24,272 --> 04:19:26,474
WE HAVE SEVERAL QUESTIONS IN THE

6460
04:19:26,474 --> 04:19:26,875
CHAT.

6461
04:19:26,875 --> 04:19:28,777
I'VE DIVIDED THEM INTO THREE

6462
04:19:28,777 --> 04:19:29,411
CATEGORIES.

6463
04:19:29,411 --> 04:19:32,047
ONE AROUND LONG-TERM COST

6464
04:19:32,047 --> 04:19:34,683
EFFECTIVENESS, NEXT AROUND COST

6465
04:19:34,683 --> 04:19:36,217
AND PRICE NEGOTIATION, THIRD AND

6466
04:19:36,217 --> 04:19:36,651
DEMANDS.

6467
04:19:36,651 --> 04:19:38,386
I'LL START WITH COST

6468
04:19:38,386 --> 04:19:38,720
EFFECTIVENESS.

6469
04:19:38,720 --> 04:19:42,557
THERE'S A QUESTION IN THE CHAT

6470
04:19:42,557 --> 04:19:44,626
FROM BYRON REGARDING HOW COST OF

6471
04:19:44,626 --> 04:19:46,594
THESE MEDICATIONS MAY BE OFFSET

6472
04:19:46,594 --> 04:19:48,563
WITH REDUCTIONS TO COMORBIDITIES

6473
04:19:48,563 --> 04:19:50,632
IN THE LONG RUN, MANY QUESTIONS

6474
04:19:50,632 --> 04:19:52,400
ALONG THESE LINES.

6475
04:19:52,400 --> 04:19:54,169
ANAND, YOU MENTIONED WORKING

6476
04:19:54,169 --> 04:19:55,270
WITH MICROSIMULATION MODELS, AND

6477
04:19:55,270 --> 04:19:56,571
RESEARCHERS, WHAT IS THE SCOPE

6478
04:19:56,571 --> 04:19:57,605
THAT SHOULD BE CONSIDERED IN

6479
04:19:57,605 --> 04:20:01,409
TERMS OF THE TIME HORIZON MODEL

6480
04:20:01,409 --> 04:20:03,712
AND COMORBIDITIES CONSIDERED IN

6481
04:20:03,712 --> 04:20:07,115
TERMS OF OBESITY-RELATED HEALTH

6482
04:20:07,115 --> 04:20:07,982
IMPROVEMENTS, BEST PRACTICE

6483
04:20:07,982 --> 04:20:09,617
RECOMMENDATIONS, CONSIDERING A

6484
04:20:09,617 --> 04:20:13,588
LIFETIME HORIZON, WHAT'S

6485
04:20:13,588 --> 04:20:14,055
REALISTIC FOR PAYERS?

6486
04:20:14,055 --> 04:20:16,424
>>  THANKS FOR THAT
QUESTION.

6487
04:20:16,424 --> 04:20:19,060
I'M NOT SURE IF THERE'S A

6488
04:20:19,060 --> 04:20:21,229
ONE-SIZE-FITS-ALL RESPONSE FOR

6489
04:20:21,229 --> 04:20:21,429
THAT.

6490
04:20:21,429 --> 04:20:23,531
AND SOME -- DAVID SHOULD COMMENT

6491
04:20:23,531 --> 04:20:25,066
ON THE PRIVATE SECTOR SIDE WHERE

6492
04:20:25,066 --> 04:20:27,569
THERE'S PROBABLY MORE PRESSURE

6493
04:20:27,569 --> 04:20:29,904
TO REALIZE SAVINGS IN A SHORTER

6494
04:20:29,904 --> 04:20:31,272
TIME FRAME, MEDICAID IS

6495
04:20:31,272 --> 04:20:34,109
CHALLENGING BECAUSE OF THE

6496
04:20:34,109 --> 04:20:35,877
CHURN.

6497
04:20:35,877 --> 04:20:37,545
I THINK FOR MEDICARE, SINCE A

6498
04:20:37,545 --> 04:20:40,515
LOT OF PAYERS FOLLOW MEDICARE,

6499
04:20:40,515 --> 04:20:45,120
GIVEN THE SITUATION THAT WE'RE

6500
04:20:45,120 --> 04:20:48,189
IN RIGHT NOW NOELIA SHOULD WEIGH

6501
04:20:48,189 --> 04:20:52,360
IN, GIVEN CMS DOESN'T TAKE

6502
04:20:52,360 --> 04:20:54,329
ACTION, CONGRESS IS GOING TO

6503
04:20:54,329 --> 04:20:57,398
LOOK AT CBO, CBO LOOKS AT

6504
04:20:57,398 --> 04:20:58,833
TEN-YEAR SCORING WINDOW,

6505
04:20:58,833 --> 04:21:00,802
SOMETIMES BEYOND THAT BUT

6506
04:21:00,802 --> 04:21:03,505
USUALLY TEN-YEAR SCORING WINDOW.

6507
04:21:03,505 --> 04:21:05,874
CERTAINLY FOR MICROSIMULATION

6508
04:21:05,874 --> 04:21:08,243
PROVIDING MORE DATA TO CBO, OF

6509
04:21:08,243 --> 04:21:10,979
WHAT ARE POTENTIAL HEALTHCARE

6510
04:21:10,979 --> 04:21:11,780
COSTS, OFFSETS OR BENEFITS

6511
04:21:11,780 --> 04:21:17,652
WITHIN TEN YEARS WOULD BE VERY

6512
04:21:17,652 --> 04:21:19,287
HELPFUL TO CBO STAFF AND SO

6513
04:21:19,287 --> 04:21:22,490
MINIMUM THAT IS IMPORTANT.

6514
04:21:22,490 --> 04:21:24,692
BUT, BOY, I THINK OTHERWISE ON

6515
04:21:24,692 --> 04:21:26,427
THE PRIVATE SECTOR SIDE, YOU

6516
04:21:26,427 --> 04:21:27,729
KNOW, I DON'T THINK PEOPLE HAVE

6517
04:21:27,729 --> 04:21:30,031
TEN YEARS TO WAIT, RIGHT?

6518
04:21:30,031 --> 04:21:32,934
AND YOU HAVE MAYBE A YEAR OR

6519
04:21:32,934 --> 04:21:34,836
TWO, THREE, OTHERWISE, YOU KNOW,

6520
04:21:34,836 --> 04:21:38,339
IF COSTS ARE REALLY HIGH,

6521
04:21:38,339 --> 04:21:41,442
THERE'S NOT A LOT OF -- YOU

6522
04:21:41,442 --> 04:21:42,844
KNOW, THERE'S NOT A LOT OF

6523
04:21:42,844 --> 04:21:44,379
CUSHION THERE, AND THAT'S WHY I

6524
04:21:44,379 --> 04:21:46,815
THINK, AGAIN, STARTING WITH

6525
04:21:46,815 --> 04:21:50,952
THOSE HIGH RISK POPULATIONS,

6526
04:21:50,952 --> 04:21:52,487
SUBPOPULATIONS WITHIN OBESITY,

6527
04:21:52,487 --> 04:21:54,989
YOU CAN DEMONSTRATE WITHIN A FEW

6528
04:21:54,989 --> 04:21:58,193
MONTHS AND WITHIN A YEAR SO THAT

6529
04:21:58,193 --> 04:21:59,294
YOU'RE PREVENTING EXPENSIVE

6530
04:21:59,294 --> 04:22:00,695
HEALTHCARE UTILIZATION AND

6531
04:22:00,695 --> 04:22:02,430
EMERGENCY ROOM VISITS AND

6532
04:22:02,430 --> 04:22:04,532
INPATIENT HOSPITALIZATIONS AND

6533
04:22:04,532 --> 04:22:07,936
YOU CAN DEMONSTRATE THAT ROI.

6534
04:22:07,936 --> 04:22:09,370
YOU WON'T DEMONSTRATE ON AVERAGE

6535
04:22:09,370 --> 04:22:10,271
INDIVIDUAL WITH OBESITY BUT

6536
04:22:10,271 --> 04:22:12,307
THOSE -- YOU KNOW, WITH

6537
04:22:12,307 --> 04:22:13,408
COMORBIDITIES AND HIGHER RISK,

6538
04:22:13,408 --> 04:22:18,513
SO AGAIN REAL WORLD EVIDENCE TO

6539
04:22:18,513 --> 04:22:19,414
IDENTIFY THAT SUBPOPULATION

6540
04:22:19,414 --> 04:22:21,382
WOULD BE MOST HELPFUL FOR THOSE

6541
04:22:21,382 --> 04:22:23,484
WHO DON'TS HAVE TEN YEARS TO

6542
04:22:23,484 --> 04:22:26,521
WAIT FOR THE RETURN ON

6543
04:22:26,521 --> 04:22:27,655
INVESTMENT.

6544
04:22:27,655 --> 04:22:31,259
SO I THINK DAVID AND NOELIA WILL

6545
04:22:31,259 --> 04:22:32,694
HAVE SOME THOUGHTS.

6546
04:22:32,694 --> 04:22:33,795
>> TOTALLY AGREE.

6547
04:22:33,795 --> 04:22:35,630
IN MY WORLD, WE'RE LOOKING FOR

6548
04:22:35,630 --> 04:22:42,070
RETURN IN THE FIRST YEAR.

6549
04:22:42,070 --> 04:22:44,372
I HEAR FEEDBACK, AM I COMING

6550
04:22:44,372 --> 04:22:45,173
THROUGH?

6551
04:22:45,173 --> 04:22:46,875
>> I'M ALSO HEARING
FEEDBACK BUT

6552
04:22:46,875 --> 04:22:47,809
YOU'RE COMING THROUGH.

6553
04:22:47,809 --> 04:22:51,045
>> MY WORLD, WE LOOK AT
PUTTING

6554
04:22:51,045 --> 04:22:52,680
IN PROGRAMS, EVERYBODY IS

6555
04:22:52,680 --> 04:23:00,021
SELLING US SOLUTIONS NOWADAYS. 

6556
04:23:00,021 --> 04:23:02,423
WITH THIS PUSH, WHAT WE WANT TO

6557
04:23:02,423 --> 04:23:04,392
SEE AT LEAST INITIALLY, SOME

6558
04:23:04,392 --> 04:23:05,493
REDUCTION IN THE PHARMACY SPEND

6559
04:23:05,493 --> 04:23:06,895
IS AN EARLY INDICATOR OF WHAT'S

6560
04:23:06,895 --> 04:23:10,198
GOING ON, ARE WE MAKING GAINS.

6561
04:23:10,198 --> 04:23:12,901
THEN MORE ON THE MEDICAL SIDE OF

6562
04:23:12,901 --> 04:23:13,601
THE EQUATION.

6563
04:23:13,601 --> 04:23:15,870
WE WANT TO SEE SOME SUCCESSES

6564
04:23:15,870 --> 04:23:17,939
WITHIN YEAR ONE.

6565
04:23:17,939 --> 04:23:20,275
YEAR TWO, BETTER START SEEING

6566
04:23:20,275 --> 04:23:22,777
THAT KIND OF SOLIDIFY.

6567
04:23:22,777 --> 04:23:30,351
YEAR THREE WE SHOULD BE GOLDEN

6568
04:23:30,351 --> 04:23:40,561
AT THAT POINT.

6569
04:23:40,561 --> 04:23:40,862
>> NOELIA?

6570
04:23:40,862 --> 04:23:47,168
>>  SEEMS LIKE WE CANNOT
HEAR

6571
04:23:47,168 --> 04:23:54,309
YOU. 

6572
04:23:54,309 --> 04:23:55,276
>> I'M HEARING FEEDBACK,
THE

6573
04:23:55,276 --> 04:23:56,844
SAME STATEMENT OVER AND OVER

6574
04:23:56,844 --> 04:23:57,178
AGAIN.

6575
04:23:57,178 --> 04:24:00,448
CAN YOU TRY SPEAKING AGAIN?

6576
04:24:00,448 --> 04:24:02,317
I'M NOT ABLE TO HEAR YOU.

6577
04:24:02,317 --> 04:24:04,619
WHY DON'T WE TAKE A MINUTE AND

6578
04:24:04,619 --> 04:24:06,688
MAYBE YOU CAN CALL INTO THE

6579
04:24:06,688 --> 04:24:10,091
PHONE NUMBER, OR OTHERWISE

6580
04:24:10,091 --> 04:24:10,692
TROUBLESHOOT.

6581
04:24:10,692 --> 04:24:14,796
I'M GOING TO CONTINUE WITH

6582
04:24:14,796 --> 04:24:15,663
QUESTIONING, WHICH IS COMING

6583
04:24:15,663 --> 04:24:17,298
FROM PATRICK IN THE CHAT WHO

6584
04:24:17,298 --> 04:24:19,834
ASKED HOW CAN WE RECONCILE THE

6585
04:24:19,834 --> 04:24:22,570
UP-FRONT COST OF GLP-1 USE WITH

6586
04:24:22,570 --> 04:24:23,871
LONG-TERM COST SAVINGS?

6587
04:24:23,871 --> 04:24:25,506
FOR EXAMPLE WILL COMMERCIAL

6588
04:24:25,506 --> 04:24:28,910
PAYERS BEAR THE BRUNT WHILE CMS

6589
04:24:28,910 --> 04:24:31,412
REALIZES COST/BENEFITS AS

6590
04:24:31,412 --> 04:24:33,181
PATIENTS AGE CAN OBESITY-RELATED

6591
04:24:33,181 --> 04:24:33,648
EXPENSES?

6592
04:24:33,648 --> 04:24:37,585
MAYBE, DAVID, YOU CAN START WITH

6593
04:24:37,585 --> 04:24:38,686
THAT ONE.

6594
04:24:38,686 --> 04:24:39,854
>> COULD YOU REPEAT THE

6595
04:24:39,854 --> 04:24:40,121
QUESTION?

6596
04:24:40,121 --> 04:24:40,655
I'M SORRY.

6597
04:24:40,655 --> 04:24:43,825
>> THE QUESTION IS HOW CAN
WE

6598
04:24:43,825 --> 04:24:45,994
RECONCILE THE UPFRONT COST OF

6599
04:24:45,994 --> 04:24:48,529
GLP-1 USE WITH LONG-TERM COST

6600
04:24:48,529 --> 04:24:50,698
SAVINGS, WILL COMMERCIAL PAYERS

6601
04:24:50,698 --> 04:24:55,303
BEAR THE BRUNT OF THE COST WHILE

6602
04:24:55,303 --> 04:24:58,172
CMS REALIZES COST-BENEFIT AS

6603
04:24:58,172 --> 04:24:59,774
PATIENTS AGE WITH

6604
04:24:59,774 --> 04:25:00,308
OBESITY-RELATED EXPENSES?

6605
04:25:00,308 --> 04:25:01,109
>>  YEAH, WE'RE ALWAYS
WORRIED

6606
04:25:01,109 --> 04:25:04,679
ABOUT COST SHIFTING THAT GOES ON

6607
04:25:04,679 --> 04:25:06,247
IN THE POPULATION, WHETHER

6608
04:25:06,247 --> 04:25:08,316
THROUGH MEDICARE OR MEDICATION

6609
04:25:08,316 --> 04:25:08,649
POPULATION.

6610
04:25:08,649 --> 04:25:10,418
BASICALLY THEY HAVE MORE POWER

6611
04:25:10,418 --> 04:25:14,222
TO NEGOTIATE SAVINGS FOR ONE

6612
04:25:14,222 --> 04:25:14,989
THING, BASICALLY FOR EVERYBODY

6613
04:25:14,989 --> 04:25:16,758
LOOKS TO PROFIT IT COMES OFF THE

6614
04:25:16,758 --> 04:25:18,159
COMMERCIAL SIDE OF THE EQUATION,

6615
04:25:18,159 --> 04:25:19,494
WHAT I END UP GETTING CHARGED AT

6616
04:25:19,494 --> 04:25:21,996
THE END OF THE DAY.

6617
04:25:21,996 --> 04:25:23,431
BUT, YEAH I THINK THERE'S A VERY

6618
04:25:23,431 --> 04:25:27,468
GOOD POINT EVEN IN THAT TIME LAG

6619
04:25:27,468 --> 04:25:29,003
SITUATION, A LOT OF THINGS

6620
04:25:29,003 --> 04:25:31,305
ESPECIALLY IN THE CARDIOVASCULAR

6621
04:25:31,305 --> 04:25:32,173
DISEASE AREAS, COMORBIDITIES

6622
04:25:32,173 --> 04:25:35,376
COME ON, IT'S GOING TO HAPPEN IN

6623
04:25:35,376 --> 04:25:38,112
LATER AGES.

6624
04:25:38,112 --> 04:25:39,981
I'VE BEEN PAYING ALONG TO HELP

6625
04:25:39,981 --> 04:25:41,449
THEM BUT LOSE CONTROL, BASICALLY

6626
04:25:41,449 --> 04:25:47,622
LOSE THE BENEFIT AT THE END.

6627
04:25:47,622 --> 04:25:48,389
GOOD POINT.

6628
04:25:48,389 --> 04:25:49,490
>> PLEASE WEIGH IN.

6629
04:25:49,490 --> 04:25:52,660
>> I'LL ADD I THINK IT IS
AN

6630
04:25:52,660 --> 04:25:56,964
INTERESTING POINT, THIS WAS ALSO

6631
04:25:56,964 --> 04:25:59,233
IN THAT REPORT THAT THE HIGHER

6632
04:25:59,233 --> 04:26:02,103
THE COMMERCIAL UPTAKE OF THIS,

6633
04:26:02,103 --> 04:26:03,471
YOU KNOW, THEORETICALLY THE

6634
04:26:03,471 --> 04:26:04,605
HEALTHIER THE POPULATION SHOULD

6635
04:26:04,605 --> 04:26:06,908
BE AS THEY AGE INTO MEDICARE AND

6636
04:26:06,908 --> 04:26:11,846
IT SHOULD BENEFIT THE MEDICARE

6637
04:26:11,846 --> 04:26:12,280
PROGRAM AS WELL.

6638
04:26:12,280 --> 04:26:22,690
AND SO SHOULD THERE BE

6639
04:26:22,690 --> 04:26:24,725
INCENTIVES, IT SHOULD HELP WITH

6640
04:26:24,725 --> 04:26:26,994
THE MEDICARE POPULATION, OR THE

6641
04:26:26,994 --> 04:26:32,200
PROGRAM, IN TERMS OF SOLVENCY.

6642
04:26:32,200 --> 04:26:33,634
>> CAN YOU HEAR ME NOW?

6643
04:26:33,634 --> 04:26:36,938
>>  YES, WE CAN HEAR YOU!

6644
04:26:36,938 --> 04:26:37,638
>> OKAY.

6645
04:26:37,638 --> 04:26:39,273
>> WEIGH IN ON EITHER OF
THE

6646
04:26:39,273 --> 04:26:41,008
EARLIER QUESTIONS, JUST THINKING

6647
04:26:41,008 --> 04:26:42,543
ABOUT THE COST EFFECTIVENESS IN

6648
04:26:42,543 --> 04:26:48,015
THE LONGER RUN.

6649
04:26:48,015 --> 04:26:48,282
>> SURE.

6650
04:26:48,282 --> 04:26:49,050
I THE CONGRESSIONAL BUDGET

6651
04:26:49,050 --> 04:26:53,287
OFFICE IS A HEAVY USER OF

6652
04:26:53,287 --> 04:26:55,256
MICROSIMULATION MODELS, LUCKY

6653
04:26:55,256 --> 04:26:56,657
RESEARCHERS RUNNING MODELS ARE

6654
04:26:56,657 --> 04:27:00,495
ENGAGED WITH US AND ANSWER MANY,

6655
04:27:00,495 --> 04:27:03,131
MANY QUESTIONS FROM US.

6656
04:27:03,131 --> 04:27:06,701
SO, YOU KNOW, AGAIN, THE BENEFIT

6657
04:27:06,701 --> 04:27:09,837
OF THOSE MODELS IS THAT THEY CAN

6658
04:27:09,837 --> 04:27:11,639
LOOK BEYOND LIKE ONE OR TWO

6659
04:27:11,639 --> 04:27:13,941
YEARS, THEY CAN LOOK, YOU KNOW,

6660
04:27:13,941 --> 04:27:15,610
WELL INTO THE FUTURE.

6661
04:27:15,610 --> 04:27:20,314
AS OPPOSED TO SOME OF THE

6662
04:27:20,314 --> 04:27:21,749
RANDOMIZED CONTROLLED TRIALS,

6663
04:27:21,749 --> 04:27:27,088
THEY INCLUDE EFFECT OF WEIGHT

6664
04:27:27,088 --> 04:27:28,789
LOSS NOT JUST ON CARDIOVASCULAR

6665
04:27:28,789 --> 04:27:31,659
CONDITIONS BUT, YOU KNOW, A

6666
04:27:31,659 --> 04:27:35,196
WHOLE SET OF MEDICAL CONDITIONS,

6667
04:27:35,196 --> 04:27:40,668
SO BECAUSE OF THAT THE EFFECT

6668
04:27:40,668 --> 04:27:42,603
FROM IMPROVED HEALTH ARE

6669
04:27:42,603 --> 04:27:43,371
BROADER.

6670
04:27:43,371 --> 04:27:46,107
THEY ARE ABLE TO SAY, YOU KNOW,

6671
04:27:46,107 --> 04:27:49,710
ON AVERAGE THESE ARE THE HEALTH

6672
04:27:49,710 --> 04:27:51,579
CARE SPENDINGS, THE CHANGE IN

6673
04:27:51,579 --> 04:27:55,283
HEALTH CARE SPENDING FOR THE

6674
04:27:55,283 --> 04:27:57,385
AVERAGE USER BUT THEY ALSO HAVE

6675
04:27:57,385 --> 04:28:02,290
ABILITY OF SAYING, WELL, WHAT IF

6676
04:28:02,290 --> 04:28:04,292
ALL THESE PEOPLE MORBIDLY OBESE

6677
04:28:04,292 --> 04:28:05,793
TAKE THESE MEDICATIONS WHAT IS

6678
04:28:05,793 --> 04:28:08,429
THE OFFSET THERE?

6679
04:28:08,429 --> 04:28:10,831
YOU KNOW, THEY CAN ALSO LOOK,

6680
04:28:10,831 --> 04:28:12,567
YOU KNOW, WHAT IF LIKE EVERYBODY

6681
04:28:12,567 --> 04:28:15,870
WHO IS LIKE JUST ABOVE 30, BMI

6682
04:28:15,870 --> 04:28:18,606
OF 30, TAKE THE MEDICATIONS, YOU

6683
04:28:18,606 --> 04:28:22,743
MIGHT SEE DIFFERENT EFFECTS SO

6684
04:28:22,743 --> 04:28:24,378
WE'RE ENGAGING IN THAT, WITH

6685
04:28:24,378 --> 04:28:27,782
THAT RESEARCH ALL THE TIME.

6686
04:28:27,782 --> 04:28:32,720
>> I WANT TO ASK A
SPECIFIC

6687
04:28:32,720 --> 04:28:32,987
QUESTION.

6688
04:28:32,987 --> 04:28:34,088
YOU MENTIONED YOU CONSIDERED

6689
04:28:34,088 --> 04:28:35,256
PRODUCTIVITY IMPROVEMENTS AS

6690
04:28:35,256 --> 04:28:37,692
PART OF YOUR COST ESTIMATES, IS

6691
04:28:37,692 --> 04:28:38,025
THAT RIGHT?

6692
04:28:38,025 --> 04:28:39,760
>>  NOT QUITE.

6693
04:28:39,760 --> 04:28:41,729
>> OKAY.

6694
04:28:41,729 --> 04:28:44,165
>> SO THE COST ESTIMATES
HAVE

6695
04:28:44,165 --> 04:28:47,235
LIKE VERY SPECIFIC GUIDELINES,

6696
04:28:47,235 --> 04:28:53,441
AND THEY NORMALLY DON'T INCLUDE

6697
04:28:53,441 --> 04:28:54,075
PRODUCTIVITY IMPROVEMENTS.

6698
04:28:54,075 --> 04:28:57,745
HOWEVER, YOU KNOW, WE DO PROVIDE

6699
04:28:57,745 --> 04:28:59,046
THE CONGRESS WITH SUPPLEMENTAL

6700
04:28:59,046 --> 04:28:59,347
INFORMATION.

6701
04:28:59,347 --> 04:29:04,085
SO, YOU KNOW, IF THERE WAS

6702
04:29:04,085 --> 04:29:05,720
EVIDENCE THAT, YOU KNOW,

6703
04:29:05,720 --> 04:29:06,687
PRODUCTIVITY WOULD IMPROVE, LIKE

6704
04:29:06,687 --> 04:29:08,556
THAT'S SOMETHING WE WOULD WANT

6705
04:29:08,556 --> 04:29:09,223
THE CONGRESS TO KNOW SO THAT

6706
04:29:09,223 --> 04:29:14,462
THEY HAVE A FULLER SET OF

6707
04:29:14,462 --> 04:29:16,130
OUTCOMES AND INFORMATION AS THEY

6708
04:29:16,130 --> 04:29:17,431
CONSIDER LEGISLATION.

6709
04:29:17,431 --> 04:29:22,169
IT'S NOT JUST, YOU KNOW, THESE

6710
04:29:22,169 --> 04:29:24,338
MEDICATIONS ARE SUPER EXPENSIVE

6711
04:29:24,338 --> 04:29:26,107
AND, YOU KNOW, SO THEY CAN LOOK

6712
04:29:26,107 --> 04:29:28,309
AT THE BROADER EFFECT OF THE

6713
04:29:28,309 --> 04:29:29,210
ECONOMY.

6714
04:29:29,210 --> 04:29:29,543
>> GREAT.

6715
04:29:29,543 --> 04:29:29,810
THANK YOU.

6716
04:29:29,810 --> 04:29:31,045
IN THE INTEREST OF TIME I WANT

6717
04:29:31,045 --> 04:29:34,215
TO MOVE TO TALKING ABOUT COST

6718
04:29:34,215 --> 04:29:35,082
AND PRICE NEGOTIATION.

6719
04:29:35,082 --> 04:29:38,019
SO IN THE CHAT JAMIE MOORE ASKS

6720
04:29:38,019 --> 04:29:43,758
CAN YOU DESCRIBE IN MORE DETAIL

6721
04:29:43,758 --> 04:29:45,826
WHAT MEDICARE PRICE NEGOTIATIONS

6722
04:29:45,826 --> 04:29:47,895
FOR SEMAGLUTIDE MIGHT LOOK LIKE

6723
04:29:47,895 --> 04:29:49,497
AND DO THESE NEGOTIATED PRICES

6724
04:29:49,497 --> 04:29:55,136
TICKLE DOWN TO THE OTHER FEDERAL

6725
04:29:55,136 --> 04:29:56,103
PROGRAMS YOU SPOKE ABOUT?

6726
04:29:56,103 --> 04:29:58,306
>>  I CAN START.

6727
04:29:58,306 --> 04:30:02,209
I THINK THE SHORT ANSWER IS WE

6728
04:30:02,209 --> 04:30:03,444
DON'T KNOW, JUST BECAUSE THIS

6729
04:30:03,444 --> 04:30:04,779
PROGRAM IS SO NEW.

6730
04:30:04,779 --> 04:30:08,816
LAST YEAR WAS THE FIRST YEAR

6731
04:30:08,816 --> 04:30:10,918
WHERE TEN DRUGS WERE NEGOTIATED

6732
04:30:10,918 --> 04:30:13,120
BY MEDICARE, AND THAT ACTUALLY

6733
04:30:13,120 --> 04:30:16,524
WON'T GO INTO EFFECT UNTIL 2026.

6734
04:30:16,524 --> 04:30:19,493
SO WE DON'T QUITE KNOW WHAT THE

6735
04:30:19,493 --> 04:30:23,097
ULTIMATE EFFECT WILL BE, WILL IT

6736
04:30:23,097 --> 04:30:29,770
BE 10%, 20%, 30% REDUCTION? 

6737
04:30:29,770 --> 04:30:31,639
THESE ARE ALSO REDUCTIONS IN

6738
04:30:31,639 --> 04:30:33,607
LIST PRICES, AS WELL, WHICH ARE

6739
04:30:33,607 --> 04:30:36,544
OFTEN DIFFERENT FROM SOME SORT

6740
04:30:36,544 --> 04:30:38,646
OF NET PRICES.

6741
04:30:38,646 --> 04:30:42,917
SO, TO WHAT EXTENT, AND HOW

6742
04:30:42,917 --> 04:30:45,219
MUCH, AND HOW QUICKLY, CERTAINLY

6743
04:30:45,219 --> 04:30:46,654
WON'T HAPPEN UNTIL 2027 SO WE

6744
04:30:46,654 --> 04:30:48,723
STILL HAVE A COUPLE OF YEARS.

6745
04:30:48,723 --> 04:30:49,724
IT'S HARD TO SAY.

6746
04:30:49,724 --> 04:30:52,226
NOW, AT THE SAME TIME ALL THIS

6747
04:30:52,226 --> 04:30:53,994
IS GOING ON, THERE'S MARKET

6748
04:30:53,994 --> 04:30:56,731
COMPETITION ONGOING. 

6749
04:30:56,731 --> 04:31:00,434
SO THERE'S A PIPELINE OF DRUGS

6750
04:31:00,434 --> 04:31:02,737
THAT COULD COME OUT NEXT COUPLE

6751
04:31:02,737 --> 04:31:06,440
YEARS AND BECOME FDA APPROVED.

6752
04:31:06,440 --> 04:31:07,875
HOW MIGHT THAT THEN REDUCE

6753
04:31:07,875 --> 04:31:08,843
PRICES AS WELL?

6754
04:31:08,843 --> 04:31:10,177
THERE WE DON'T KNOW BECAUSE A

6755
04:31:10,177 --> 04:31:13,381
LOT OF THESE DRUGS EVEN THEY ARE

6756
04:31:13,381 --> 04:31:15,249
SIMILAR MAY DIFFER IN TERMS OF

6757
04:31:15,249 --> 04:31:18,252
THE CLINICAL BENEFIT AND HOW

6758
04:31:18,252 --> 04:31:19,053
E

6759
04:31:19,053 --> 04:31:20,354
EFFECTIVE THEY ARE, SIDE

6760
04:31:20,354 --> 04:31:22,523
EFFECTS, WHETHER YOU CAN TAKE

6761
04:31:22,523 --> 04:31:25,292
ORALLY, NOT THROUGH SUBCU.

6762
04:31:25,292 --> 04:31:27,895
SO THERE ARE A NUMBER OF FACTORS

6763
04:31:27,895 --> 04:31:30,631
THAT WILL TERM WHETHER THAT

6764
04:31:30,631 --> 04:31:31,832
MARKET COMPETITION, HOW MUCH IT

6765
04:31:31,832 --> 04:31:35,102
WILL REDUCE THE PRICE AND HOW

6766
04:31:35,102 --> 04:31:37,071
QUICKLY, AND THERE'S THE

6767
04:31:37,071 --> 04:31:38,506
NEGOTIATION SIDE AS WAS ASKED IN

6768
04:31:38,506 --> 04:31:40,040
THE QUESTION.

6769
04:31:40,040 --> 04:31:42,209
SO, I'M NOT SURE EXACTLY WHAT WE

6770
04:31:42,209 --> 04:31:42,977
KNOW.

6771
04:31:42,977 --> 04:31:46,180
WE DO KNOW THAT CURRENTLY NET

6772
04:31:46,180 --> 04:31:48,282
PRICES FOR GLP-1s ARE IN THE

6773
04:31:48,282 --> 04:31:50,918
EIGHT TO NINE THOUSAND DOLLAR

6774
04:31:50,918 --> 04:31:51,285
RANGE.

6775
04:31:51,285 --> 04:31:53,087
OTHER COUNTRIES ARE ALWAYS CITED

6776
04:31:53,087 --> 04:31:56,824
AS A BENCHMARK, OTHER COUNTRIES

6777
04:31:56,824 --> 04:31:58,125
PARTICULARLY IN EUROPE, THESE

6778
04:31:58,125 --> 04:31:59,293
SAME DRUGS ARE A THOUSAND

6779
04:31:59,293 --> 04:32:01,095
DOLLARS OR TWO THOUSAND DOLLARS,

6780
04:32:01,095 --> 04:32:05,132
SO THE DELTA IS PRETTY BIG

6781
04:32:05,132 --> 04:32:05,366
THERE.

6782
04:32:05,366 --> 04:32:13,040
HOW MUCH  WE'LL BE ABLE TO GET

6783
04:32:13,040 --> 04:32:14,675
THERE, HOW QUICKLY WE GET THERE

6784
04:32:14,675 --> 04:32:18,212
I JUST DON'T THINK WE KNOW THE

6785
04:32:18,212 --> 04:32:20,614
ANSWER TO THAT.

6786
04:32:20,614 --> 04:32:24,752
BUT, DAVID AND NOELIA MAY HAVE

6787
04:32:24,752 --> 04:32:25,853
THOUGHTS.

6788
04:32:25,853 --> 04:32:29,123
>> I'LL JUST SAY IN OUR
2024

6789
04:32:29,123 --> 04:32:33,260
REPORT, WE DO SHOW SIGNIFICANT

6790
04:32:33,260 --> 04:32:38,732
REDUCTION IN ANNUAL NET FEDERAL

6791
04:32:38,732 --> 04:32:39,967
COSTS IN MEDICARE.

6792
04:32:39,967 --> 04:32:44,905
BUT EVEN, YOU KNOW, WITH THOSE

6793
04:32:44,905 --> 04:32:47,408
PRICES RELATIVE, YOU KNOW, THE

6794
04:32:47,408 --> 04:32:48,943
PRICES ARE STILL PRETTY HIGH,

6795
04:32:48,943 --> 04:32:51,011
AND YOU HAVE A LOT OF PEOPLE

6796
04:32:51,011 --> 04:32:54,515
TAKING THE MEDICATIONS SO

6797
04:32:54,515 --> 04:32:56,517
RELATIVE TO MULTIPLYING TWO

6798
04:32:56,517 --> 04:32:58,352
NUMBERS, STILL A REALLY BIG

6799
04:32:58,352 --> 04:32:58,586
NUMBER.

6800
04:32:58,586 --> 04:33:00,187
SO I THINK THERE WAS A QUESTION

6801
04:33:00,187 --> 04:33:08,629
IN THE Q&A ABOUT HOW LOW
THESE

6802
04:33:08,629 --> 04:33:09,497
MEDICATIONS -- HOW LOW WOULD

6803
04:33:09,497 --> 04:33:15,870
NOTE PRICE -- NET PRICE HAVE TO

6804
04:33:15,870 --> 04:33:18,906
BE TO COMPLETELY OFFSET EACH

6805
04:33:18,906 --> 04:33:21,208
OTHER OR HAVE, YOU KNOW, EVEN

6806
04:33:21,208 --> 04:33:21,442
SAVINGS.

6807
04:33:21,442 --> 04:33:24,612
I THINK WE HAVEN'T DONE THAT

6808
04:33:24,612 --> 04:33:24,979
CALCULATION.

6809
04:33:24,979 --> 04:33:27,248
WE COULD, BUT THEY WOULD HAVE TO

6810
04:33:27,248 --> 04:33:28,782
BE MUCH, MUCH LOWER.

6811
04:33:28,782 --> 04:33:29,650
>> YEAH, I WILL SAY THERE
ARE

6812
04:33:29,650 --> 04:33:31,652
THREE QUESTIONS IN THE CHAT

6813
04:33:31,652 --> 04:33:33,821
RELATED ABOUT HOW LOW THE PRICE

6814
04:33:33,821 --> 04:33:35,256
HAS TO BE, ONE THOUSAND DOLLARS

6815
04:33:35,256 --> 04:33:37,324
A MONTH DOES NOT SEEM

6816
04:33:37,324 --> 04:33:41,695
SUSTAINABLE, ALSO ARE THERE NOT

6817
04:33:41,695 --> 04:33:42,696
POLICIES TO ADDRESS WHAT

6818
04:33:42,696 --> 04:33:46,066
COMPANIES ARE ALLOWED TO CHARGE,

6819
04:33:46,066 --> 04:33:47,067
WE COULD FIND ANSWERS IN THE

6820
04:33:47,067 --> 04:33:51,005
WHITE PAPER THAT CAME OUT IN

6821
04:33:51,005 --> 04:33:53,173
APRIL, ICER STANDS FOR THE

6822
04:33:53,173 --> 04:33:59,213
INSTITUTE FOR CLINICAL AND

6823
04:33:59,213 --> 04:34:01,181
ECONOMIC REVIEW, HOW DO YOU

6824
04:34:01,181 --> 04:34:06,654
DETERMINE THE ICER PAPER AFTER

6825
04:34:06,654 --> 04:34:13,561
YOU LOOKED AT IT? 

6826
04:34:13,561 --> 04:34:14,929
>> I CAN START, ONE OF THE

6827
04:34:14,929 --> 04:34:16,530
SLIDES SUMMARIZED SOME OF THE

6828
04:34:16,530 --> 04:34:17,731
KEY OPTIONS THERE.

6829
04:34:17,731 --> 04:34:19,800
AGAIN, I DON'T THINK THERE'S ANY

6830
04:34:19,800 --> 04:34:22,202
MAGIC BULLET BUT I DO THINK SORT

6831
04:34:22,202 --> 04:34:24,305
OF PICTURING THAT SLIDE NOW BUT

6832
04:34:24,305 --> 04:34:29,009
I THINK IT'S THE COMBINATION,

6833
04:34:29,009 --> 04:34:29,777
AGAIN, OF IDENTIFYING

6834
04:34:29,777 --> 04:34:31,078
SUBPOPULATIONS THROUGH REAL

6835
04:34:31,078 --> 04:34:33,180
WORLD EVIDENCE AND WHILE WE'RE

6836
04:34:33,180 --> 04:34:36,684
IN THIS SORT OF MURKY TIME,

6837
04:34:36,684 --> 04:34:39,086
ALONG WITH AGGRESSIVE PRICE

6838
04:34:39,086 --> 04:34:43,223
NEGOTIATION, I THINK IT'S THAT

6839
04:34:43,223 --> 04:34:45,526
COMBINATION, THAT'S WHAT'S

6840
04:34:45,526 --> 04:34:47,962
REALLY NEEDED AT THIS POINT.

6841
04:34:47,962 --> 04:34:48,729
YOU KNOW, UNFORTUNATELY

6842
04:34:48,729 --> 04:34:49,964
EVERYBODY WHO COULD BENEFIT IS

6843
04:34:49,964 --> 04:34:52,433
NOT GOING TO IMMEDIATELY GET

6844
04:34:52,433 --> 04:34:54,101
ACCESS, BUT WHO ARE THOSE THAT

6845
04:34:54,101 --> 04:34:57,504
WE CAN IDENTIFY THROUGH REAL

6846
04:34:57,504 --> 04:34:59,373
WORLD EVIDENCE WITH ASSOCIATED

6847
04:34:59,373 --> 04:35:01,976
AS DAVID HAS EMPHASIZED

6848
04:35:01,976 --> 04:35:03,944
LIFESTYLE MANAGEMENT, AND THEN

6849
04:35:03,944 --> 04:35:05,279
FOR HOW LONG, AGAIN, REAL WORLD

6850
04:35:05,279 --> 04:35:06,914
EVIDENCE, HOW DO THEY NEED TO BE

6851
04:35:06,914 --> 04:35:08,882
ON THE DRUGS, IF WE COULD GET

6852
04:35:08,882 --> 04:35:11,952
THOSE DRUGS IN WHILE MARKET

6853
04:35:11,952 --> 04:35:13,921
COMPETITION AND DRUGS

6854
04:35:13,921 --> 04:35:14,588
NEGOTIATION SIGNIFICANTLY REDUCE

6855
04:35:14,588 --> 04:35:15,856
PRICES AT LEAST BY HALF IN THE

6856
04:35:15,856 --> 04:35:17,758
NEXT COUPLE YEARS I THINK THAT'S

6857
04:35:17,758 --> 04:35:23,564
SORT OF A PATH FORWARD.

6858
04:35:23,564 --> 04:35:26,734
>> I'LL JUST ADD THAT
QUICKLY,

6859
04:35:26,734 --> 04:35:30,204
YOU KNOW, PART OF OUR ESTIMATE

6860
04:35:30,204 --> 04:35:35,609
INCLUDES PEOPLE WHO ARE TAKING

6861
04:35:35,609 --> 04:35:39,647
THE DRUGS FOR SHORT PERIODS OF

6862
04:35:39,647 --> 04:35:40,881
TIME, WHICH ACCRUES COST, BUT

6863
04:35:40,881 --> 04:35:42,783
YOU DON'T SEE THE BENEFITS.

6864
04:35:42,783 --> 04:35:47,321
SO I THINK, YOU KNOW, OVER TIME

6865
04:35:47,321 --> 04:35:50,691
LIKE ADHERENCE CAN GO UP, YOU

6866
04:35:50,691 --> 04:35:51,892
KNOW, THAT INCREASES COST, BUT,

6867
04:35:51,892 --> 04:35:53,327
YOU KNOW, IF THE PRICES ARE

6868
04:35:53,327 --> 04:35:57,197
LOWER IT DOESN'T INCREASE COST

6869
04:35:57,197 --> 04:35:58,399
SO MUCH.

6870
04:35:58,399 --> 04:36:00,234
THERE'S DEFINITELY A DANCE HERE.

6871
04:36:00,234 --> 04:36:03,103
YOU KNOW, I'LL ALSO SAY THAT,

6872
04:36:03,103 --> 04:36:06,140
YOU KNOW, WE -- CONGRESSIONAL

6873
04:36:06,140 --> 04:36:07,775
BUDGET OFFICE LIKE BY, YOU KNOW,

6874
04:36:07,775 --> 04:36:10,911
IT'S OUR MANDATE TO LOOK AT

6875
04:36:10,911 --> 04:36:14,014
COSTS, BUT THERE ARE MANY

6876
04:36:14,014 --> 04:36:18,619
BENEFITS PROVEN BY MANY PEOPLE

6877
04:36:18,619 --> 04:36:20,621
IN THE VIRTUAL ROOM IN REGARDS

6878
04:36:20,621 --> 04:36:21,588
TO HEALTH.

6879
04:36:21,588 --> 04:36:25,526
WE'RE LOOKING AT A VERY LIKE

6880
04:36:25,526 --> 04:36:29,263
NARROW, YOU KNOW, VERY NARROW

6881
04:36:29,263 --> 04:36:30,030
FOCUS.

6882
04:36:30,030 --> 04:36:31,365
>> ON THE SUBJECT OF
ADHERENCE,

6883
04:36:31,365 --> 04:36:33,667
I WANT TO TALK ABOUT DEMAND AND

6884
04:36:33,667 --> 04:36:36,603
PUT DAVID IN THE HOT SEAT.

6885
04:36:36,603 --> 04:36:39,139
SO, YOU MENTIONED THE CHALLENGE

6886
04:36:39,139 --> 04:36:41,442
OF INCREASE HEALTHCARE COSTS,

6887
04:36:41,442 --> 04:36:42,209
BEING PASSED TO EMPLOYEES.

6888
04:36:42,209 --> 04:36:46,914
THIS IS A QUESTION FROM THE

6889
04:36:46,914 --> 04:36:47,448
CHAT.

6890
04:36:47,448 --> 04:36:48,782
HAVE YOU ASKED TEACHERS WHETHER

6891
04:36:48,782 --> 04:36:54,021
THEY WOULD BE WILLING TO ACCEPT

6892
04:36:54,021 --> 04:36:56,356
A 3 TO 4 INCREASE TO COVER FOR

6893
04:36:56,356 --> 04:36:56,724
WEIGHT LOSS?

6894
04:36:56,724 --> 04:36:57,524
>>  I HAVE NOT.

6895
04:36:57,524 --> 04:37:00,027
I HAD TO GO THE OPPOSITE LATELY.

6896
04:37:00,027 --> 04:37:02,763
I REPORT TO A BOARD OF TRUSTS,

6897
04:37:02,763 --> 04:37:04,631
HALF UNION, HALF MANAGEMENT TYPE

6898
04:37:04,631 --> 04:37:05,032
THING.

6899
04:37:05,032 --> 04:37:06,700
I HAVE THE UNION PRESIDENT AND

6900
04:37:06,700 --> 04:37:09,103
VICE PRESIDENT SIT THERE ON MY

6901
04:37:09,103 --> 04:37:09,870
BOARD OF TRUST.

6902
04:37:09,870 --> 04:37:13,173
WHEN WE HAD TO STEP AWAY FROM

6903
04:37:13,173 --> 04:37:17,177
GLP-1s, THEY WERE LOOKING AT

6904
04:37:17,177 --> 04:37:19,079
PREMIUM INCREASES 11 TO 12% TYPE

6905
04:37:19,079 --> 04:37:19,346
SITUATION.

6906
04:37:19,346 --> 04:37:20,814
IT WAS LIKE WE WERE DOING

6907
04:37:20,814 --> 04:37:26,286
EVERYTHING WE COULD TO BASICALLY

6908
04:37:26,286 --> 04:37:28,055
REDUCE, WHAT'S GOING ON IN THE

6909
04:37:28,055 --> 04:37:29,323
CATASTROPHIC WORLD WE'VE STEPPED

6910
04:37:29,323 --> 04:37:31,558
INTO AND THEY REALIZE THE NEED.

6911
04:37:31,558 --> 04:37:33,627
BASICALLY TO TAKE CARE OF THE

6912
04:37:33,627 --> 04:37:35,696
POPULATION AS A WHOLE.

6913
04:37:35,696 --> 04:37:38,132
AND DO WHAT WE COULD DO TO KEEP

6914
04:37:38,132 --> 04:37:41,502
PRICES IN LINE TO TAKE CARE OF

6915
04:37:41,502 --> 04:37:42,736
TEACHERS BUDGET THE BEST WE

6916
04:37:42,736 --> 04:37:42,936
COULD.

6917
04:37:42,936 --> 04:37:45,272
WHEN IT COMES TO COST INCREASE,

6918
04:37:45,272 --> 04:37:50,077
25% OUT OF THEIR POCKET, 75% OUT

6919
04:37:50,077 --> 04:37:54,681
OF THE SCHOOL BOARD POCKET

6920
04:37:54,681 --> 04:37:54,948
SITUATION.

6921
04:37:54,948 --> 04:37:56,116
I RECEIVED SUPPORT, OF THE FOLKS

6922
04:37:56,116 --> 04:37:57,384
KNOWING WHAT THE IMPACT WAS AND

6923
04:37:57,384 --> 04:38:02,222
WHAT WE NEEDED TO GAIN TO STAY

6924
04:38:02,222 --> 04:38:03,257
SUSTAINABLE.

6925
04:38:03,257 --> 04:38:06,393
>> MY LAST QUESTION FOR

6926
04:38:06,393 --> 04:38:08,495
EVERYONE, WHAT DATA ON LIKELY

6927
04:38:08,495 --> 04:38:10,197
OBESITY TREATMENT UPTAKE AND

6928
04:38:10,197 --> 04:38:13,300
DEMAND WOULD BE THE MOST -- BEST

6929
04:38:13,300 --> 04:38:14,601
TO INFORM CARE AND DECISION

6930
04:38:14,601 --> 04:38:15,169
MAKING?

6931
04:38:15,169 --> 04:38:16,270
IN ORDER TO ASSESS HOW MUCH OF A

6932
04:38:16,270 --> 04:38:17,805
HIT PEOPLE WILL TAKE WE NEED TO

6933
04:38:17,805 --> 04:38:19,206
KNOW HOW MUCH PEOPLE ARE GOING

6934
04:38:19,206 --> 04:38:26,747
TO BE INTERESTED IN THESE DRUGS

6935
04:38:26,747 --> 04:38:27,414
REALISTICALLY.

6936
04:38:27,414 --> 04:38:28,549
>> I THINK IN MEDICARE,
YOU

6937
04:38:28,549 --> 04:38:33,654
KNOW, WE'RE IN A LITTLE BIT OF A

6938
04:38:33,654 --> 04:38:35,622
PICKLE BECAUSE MEDICARE DOESN'T

6939
04:38:35,622 --> 04:38:38,125
COVER THE DRUGS.

6940
04:38:38,125 --> 04:38:41,228
SO, YOU KNOW, BY VIRTUE OF THAT,

6941
04:38:41,228 --> 04:38:43,597
WE CAN'T GO TO MEDICARE, YOU

6942
04:38:43,597 --> 04:38:45,165
KNOW, CLAIMS AND SEE HOW MANY

6943
04:38:45,165 --> 04:38:50,504
PEOPLE ARE TAKING IT UP.

6944
04:38:50,504 --> 04:38:54,041
SO, BUT WE COULD, YOU KNOW, DRAW

6945
04:38:54,041 --> 04:39:00,480
ON MAYBE LIKE MEDICARE ADVANTAGE

6946
04:39:00,480 --> 04:39:03,217
CLAIMS, OR INFORMATION THERE,

6947
04:39:03,217 --> 04:39:12,526
OR, YOU KNOW, LIKE -- SO I THINK

6948
04:39:12,526 --> 04:39:13,493
THAT'S DEFINITELY A CHALLENGE.

6949
04:39:13,493 --> 04:39:18,899
YOU KNOW, I THINK SO TAKING

6950
04:39:18,899 --> 04:39:20,400
INFORMATION FROM OTHER CLAIMS

6951
04:39:20,400 --> 04:39:24,104
WHERE YOU LOOK, YOU KNOW, YOU'RE

6952
04:39:24,104 --> 04:39:25,439
LOOKING AT DIFFERENT POPULATION,

6953
04:39:25,439 --> 04:39:27,207
MUCH YOUNGER POPULATION,

6954
04:39:27,207 --> 04:39:30,143
POSSIBLY POPULATION THAT HAS

6955
04:39:30,143 --> 04:39:31,078
MUCH FEWER COMORBIDITIES OR, YOU

6956
04:39:31,078 --> 04:39:37,351
KNOW, MAYBE THEY ARE TAKING MUCH

6957
04:39:37,351 --> 04:39:39,887
FEWER MEDICATIONS, SO DOCTORS

6958
04:39:39,887 --> 04:39:42,956
MIGHT BE MORE WILLING TO

6959
04:39:42,956 --> 04:39:43,423
PRESCRIBE ANTI-OBESITY

6960
04:39:43,423 --> 04:39:44,925
MEDICATION, I THINK WE HAVE TO

6961
04:39:44,925 --> 04:39:47,327
BE CAREFUL ABOUT HOW WE

6962
04:39:47,327 --> 04:39:49,630
TRANSLATE THAT EVIDENCE INTO

6963
04:39:49,630 --> 04:39:52,599
EVIDENCE FOR THE MEDICARE

6964
04:39:52,599 --> 04:39:53,433
POPULATION.

6965
04:39:53,433 --> 04:39:53,734
>> GREAT.

6966
04:39:53,734 --> 04:39:55,335
ANAND AND DAVID IN 30 SECONDS

6967
04:39:55,335 --> 04:39:59,373
YOUR THOUGHTS HOW WE GET GOOD

6968
04:39:59,373 --> 04:39:59,840
DEMAND DATA?

6969
04:39:59,840 --> 04:40:02,142
>>  I THINK WE CAN TAKE A
LOOK

6970
04:40:02,142 --> 04:40:03,443
AT THE REQUIREMENTS AND

6971
04:40:03,443 --> 04:40:06,179
UNDERSTAND WHAT YOUR BMIs ARE,

6972
04:40:06,179 --> 04:40:07,147
DIFFERENT COMORBIDITIES ARE

6973
04:40:07,147 --> 04:40:08,282
WITHIN YOUR POPULATION.

6974
04:40:08,282 --> 04:40:09,883
AND TRY TO FACTOR IN, YOU KNOW,

6975
04:40:09,883 --> 04:40:12,085
WHAT KIND OF PERCENTAGE OF THAT

6976
04:40:12,085 --> 04:40:13,954
POPULATION WOULD ACTUALLY GET

6977
04:40:13,954 --> 04:40:16,456
ENGAGED WITH THIS.

6978
04:40:16,456 --> 04:40:18,625
BUT IT'S -- YOU THINK YOU KNOW,

6979
04:40:18,625 --> 04:40:20,661
BUT THERE'S A LOT OF UNKNOWNS IN

6980
04:40:20,661 --> 04:40:22,162
THE POPULATION WHEN IT COMES TO

6981
04:40:22,162 --> 04:40:23,263
WHAT'S TRULY GOING ON.

6982
04:40:23,263 --> 04:40:25,999
YOU'RE NOT GOING TO HAVE ALL THE

6983
04:40:25,999 --> 04:40:27,768
STATISTICS ON EVERYBODY TYPE

6984
04:40:27,768 --> 04:40:28,402
SITUATION.

6985
04:40:28,402 --> 04:40:29,169
BUT I DON'T KNOW.

6986
04:40:29,169 --> 04:40:30,804
TAKE A LOOK AT THE OBESITY

6987
04:40:30,804 --> 04:40:33,006
PERCENTAGE OF THE POPULATION,

6988
04:40:33,006 --> 04:40:36,209
WORK YOUR WAY BACKWARDS TYPE

6989
04:40:36,209 --> 04:40:36,443
THING.

6990
04:40:36,443 --> 04:40:39,379
COME UP WITH A PERCENTAGE.

6991
04:40:39,379 --> 04:40:40,914
DIFFERENT TODAY VERSUS WHAT WILL

6992
04:40:40,914 --> 04:40:44,418
HAPPEN TOMORROW AS WE GO TO PILL

6993
04:40:44,418 --> 04:40:45,118
FORM.

6994
04:40:45,118 --> 04:40:46,286
I'M SORRY.

6995
04:40:46,286 --> 04:40:49,356
>> YEAH, I'LL ADD YOU'RE
NEVER

6996
04:40:49,356 --> 04:40:52,292
GOING TO HAVE 100% UPTAKE.

6997
04:40:52,292 --> 04:40:54,261
THERE WILL BE REASONS, SIDE

6998
04:40:54,261 --> 04:40:56,263
EFFECTS, COST, NOT WANTING TO

6999
04:40:56,263 --> 04:40:58,565
TAKE A MEDICINE, AND THAT'S WHY

7000
04:40:58,565 --> 04:41:00,067
A LOT OF MICROSIMULATION

7001
04:41:00,067 --> 04:41:01,201
STUDIES, THEY ARE ASSUMING NOT

7002
04:41:01,201 --> 04:41:06,440
EVEN 50 OR 7  5 BUT LOWER, TWO,

7003
04:41:06,440 --> 04:41:09,176
FIVE, TEN, FIFTEEN, 20% UPTAKE

7004
04:41:09,176 --> 04:41:10,811
RATES BASED ON, AGAIN, PAST DATA

7005
04:41:10,811 --> 04:41:14,548
AND LOOKING AT OTHER MEDICATIONS

7006
04:41:14,548 --> 04:41:17,718
AND SO I'LL JUST GO BACK TO

7007
04:41:17,718 --> 04:41:19,152
CONCLUDING THOUGHT, AGAIN, SO

7008
04:41:19,152 --> 04:41:21,221
MANY PLACES JUST IN THIS

7009
04:41:21,221 --> 04:41:23,323
DISCUSSION WHERE REAL WORLD

7010
04:41:23,323 --> 04:41:25,892
EVIDENCE WOULD BE SO IMPORTANT,

7011
04:41:25,892 --> 04:41:26,693
WHAT ARE SUBPOPULATIONS, HOW DO

7012
04:41:26,693 --> 04:41:28,862
YOU FIT IN LIFESTYLE MANAGEMENT,

7013
04:41:28,862 --> 04:41:30,731
WHAT'S THE OFF-RAMP FOR

7014
04:41:30,731 --> 04:41:31,298
MEDICATION?

7015
04:41:31,298 --> 04:41:33,900
ALL OF THAT, YOU KNOW, IF WE CAN

7016
04:41:33,900 --> 04:41:36,203
START TO STUDY THAT USING EHR

7017
04:41:36,203 --> 04:41:38,638
AND REAL WORLD DATA THAT WOULD

7018
04:41:38,638 --> 04:41:40,173
BE REALLY HELPFUL.

7019
04:41:40,173 --> 04:41:40,741
>> FANTASTIC.

7020
04:41:40,741 --> 04:41:43,243
THANK YOU, EVERYONE, FOR YOUR

7021
04:41:43,243 --> 04:41:44,111
PRESENTATIONS, YOUR COMMENTARY,

7022
04:41:44,111 --> 04:41:45,545
AND EVERYONE IN THE AUDIENCE FOR

7023
04:41:45,545 --> 04:41:47,047
QUESTIONS.

7024
04:41:47,047 --> 04:41:54,187
I WILL PASS IT BACK TO DR.

7025
04:41:54,187 --> 04:41:54,755
HAILS.

7026
04:41:54,755 --> 04:41:57,157
>> THANK YOU FOR THE
ENGAGING

7027
04:41:57,157 --> 04:41:57,557
DISCUSSION.

7028
04:41:57,557 --> 04:42:02,195
WE'RE GOING TO TAKE JUST ABOUT A

7029
04:42:02,195 --> 04:42:04,464
10-MINUTE BREAK, BACK AT 2:55:00

7030
04:42:04,464 --> 04:42:05,642
P.M. EASTERN TIME. 

7031
04:42:10,134 --> 04:42:12,102
>> OUR LAST SESSION FOR
DAY 1 OF

7032
04:42:12,102 --> 04:42:14,838
THE WORKSHOP, I'D LIKE TO

7033
04:42:14,838 --> 04:42:17,474
WELCOME DR. DARREN TOH,

7034
04:42:17,474 --> 04:42:18,676
MODERATOR, PHO METHODOLOGIC

7035
04:42:18,676 --> 04:42:21,311
PRIECHS TO REAL WORLD EVIDENCE

7036
04:42:21,311 --> 04:42:26,450
GENERATION FOR GLP-1 THERAPIES. 

7037
04:42:26,450 --> 04:42:26,784
DR. TOH?

7038
04:42:26,784 --> 04:42:28,852
>>  THANK YOU.

7039
04:42:28,852 --> 04:42:29,953
I'M DARREN TOH, PROFESSOR HERE

7040
04:42:29,953 --> 04:42:33,657
IN THE DEPARTMENT OF POPULATION

7041
04:42:33,657 --> 04:42:35,426
MEDICINE AT HARVARD MEDICAL

7042
04:42:35,426 --> 04:42:37,494
SCHOOL AND PILGRIM HEALTH CARE

7043
04:42:37,494 --> 04:42:37,761
INSTITUTE.

7044
04:42:37,761 --> 04:42:40,998
WE HAVE THREE EXCELLENT SPEAKERS

7045
04:42:40,998 --> 04:42:41,198
TODAY.

7046
04:42:41,198 --> 04:42:44,702
WE'LL HEAR FROM THEM FIRST AND

7047
04:42:44,702 --> 04:42:46,670
THEN WE'LL FOLLOW THEIR

7048
04:42:46,670 --> 04:42:47,237
PRESENTATION BY MODERATED

7049
04:42:47,237 --> 04:42:54,378
DISCUSSION AND Q&A SESSION.

7050
04:42:54,378 --> 04:42:56,213
I'LL BRIEFLY INTRODUCE THE

7051
04:42:56,213 --> 04:42:57,514
SPEAKERS BECAUSE IT WOULD TAKE

7052
04:42:57,514 --> 04:42:59,616
TOO MUCH TIME IF I LISTED

7053
04:42:59,616 --> 04:43:00,117
ACCOMPLISHMENTS.

7054
04:43:00,117 --> 04:43:06,490
PLEASE GO TO THE WORKSHOP

7055
04:43:06,490 --> 04:43:10,994
WEBSITE FOR BIOSKETCHES. 

7056
04:43:10,994 --> 04:43:18,402
FIRST IS DR. ANNA JESTREBOFF,

7057
04:43:18,402 --> 04:43:22,806
FOUNDING DIRECTOR OF YALE

7058
04:43:22,806 --> 04:43:26,076
OBESITY RESEARCH CENTER, HAS LED

7059
04:43:26,076 --> 04:43:28,712
AND PUBLISHED SEVERAL SEMINAR

7060
04:43:28,712 --> 04:43:31,982
TRIALS ON GLP-1 AND

7061
04:43:31,982 --> 04:43:32,983
MULTI-RECEPTOR AGONISTS, SOME

7062
04:43:32,983 --> 04:43:38,889
WERE HIGHLIGHTED IN EARLIER

7063
04:43:38,889 --> 04:43:40,290
SESSIONS TODAY.

7064
04:43:40,290 --> 04:43:44,495
WE WILL SHARE SOME OF THE REAL

7065
04:43:44,495 --> 04:43:46,463
WORLD PATIENT CASES TO HIGHLIGHT

7066
04:43:46,463 --> 04:43:51,068
THE NEED FOR MORE AND BETTER

7067
04:43:51,068 --> 04:43:53,570
TRIALS AND REAL WORLD DATA

7068
04:43:53,570 --> 04:43:53,804
STUDIES.

7069
04:43:53,804 --> 04:43:55,305
>> THANK YOU FOR THE
PRODUCTION.

7070
04:43:55,305 --> 04:43:57,608
IT'S MY PLEASURE TO BE HERE

7071
04:43:57,608 --> 04:43:58,008
TODAY.

7072
04:43:58,008 --> 04:44:00,577
I'VE LEARNED SO MUCH.

7073
04:44:00,577 --> 04:44:02,913
I'LL BE GIVING A DIFFERENT

7074
04:44:02,913 --> 04:44:05,015
PERSPECTIVE AND PRESENT A COUPLE

7075
04:44:05,015 --> 04:44:05,716
PATIENTS.

7076
04:44:05,716 --> 04:44:07,751
THESE ARE MY DISCLOSURES.

7077
04:44:07,751 --> 04:44:09,553
I SERVE ON SCIENTIFIC ADVISORY

7078
04:44:09,553 --> 04:44:10,821
BOARDS AND LEAD CLINICAL TRIALS

7079
04:44:10,821 --> 04:44:14,324
WITH OUR INDUSTRY PARTNERS WHO

7080
04:44:14,324 --> 04:44:16,760
ARE DEVELOPING THESE

7081
04:44:16,760 --> 04:44:17,528
THERAPEUTICS.

7082
04:44:17,528 --> 04:44:18,929
I WILL BE MENTIONING OFF LABEL

7083
04:44:18,929 --> 04:44:22,533
USE OF OLDER MEDICATIONS THAT

7084
04:44:22,533 --> 04:44:24,067
HAVE BEEN MENTIONED TODAY.

7085
04:44:24,067 --> 04:44:27,137
SO, MY TALK IS SLIGHTLY

7086
04:44:27,137 --> 04:44:27,538
DIFFERENT.

7087
04:44:27,538 --> 04:44:31,208
IT FOCUSES ON WHY WE'RE ALL HERE

7088
04:44:31,208 --> 04:44:31,542
TODAY.

7089
04:44:31,542 --> 04:44:33,510
WE'RE ALL HERE TODAY BECAUSE WE

7090
04:44:33,510 --> 04:44:35,179
WANT TO HELP OUR PATIENTS.

7091
04:44:35,179 --> 04:44:37,681
BECAUSE WE WANT TO HELP PEOPLE

7092
04:44:37,681 --> 04:44:38,649
LIVING WITH OBESITY.

7093
04:44:38,649 --> 04:44:40,417
AND IN ORDER TO DO THAT WE NEED

7094
04:44:40,417 --> 04:44:42,786
TO KNOW WHAT GAPS ARE AND WHAT

7095
04:44:42,786 --> 04:44:44,555
THE QUESTIONS ARE.

7096
04:44:44,555 --> 04:44:48,258
WHO BETTER TO INFORM US THAN OUR

7097
04:44:48,258 --> 04:44:50,327
PATIENTS AND PARTICIPANTS, THEY

7098
04:44:50,327 --> 04:44:51,662
TEACH US EVERYTHING.

7099
04:44:51,662 --> 04:44:54,598
SO, I'LL START WITH TWO CASES.

7100
04:44:54,598 --> 04:44:56,700
ONE IS A PATIENT WHO ACTUALLY

7101
04:44:56,700 --> 04:44:58,335
WAS IN ONE OF OUR CLINICAL

7102
04:44:58,335 --> 04:44:59,970
TRIALS AND THEN TRANSITIONED TO

7103
04:44:59,970 --> 04:45:02,506
BE IN MY CLINIC, AND THE SECOND

7104
04:45:02,506 --> 04:45:04,474
A CLINIC PATIENT I'VE SEEN FOR

7105
04:45:04,474 --> 04:45:05,142
MANY YEARS.

7106
04:45:05,142 --> 04:45:07,744
SO THIS FIRST PATIENT IS A

7107
04:45:07,744 --> 04:45:08,612
49-YEAR-OLD FEMALE, AND THE

7108
04:45:08,612 --> 04:45:10,047
FIRST THING THAT I DID WHEN SHE

7109
04:45:10,047 --> 04:45:12,549
CAME TO SEE ME IN CLINIC WAS

7110
04:45:12,549 --> 04:45:13,450
LOOK AT HER EMR.

7111
04:45:13,450 --> 04:45:15,953
AND I LOOKED AT HER BMI

7112
04:45:15,953 --> 04:45:16,553
TRAJECTORY.

7113
04:45:16,553 --> 04:45:21,225
AS YOU CAN SEE OVER THE HOURS OF

7114
04:45:21,225 --> 04:45:22,326
SEVERAL YEARS SHE LOST WEIGHT

7115
04:45:22,326 --> 04:45:22,659
SUCCESSFULLY.

7116
04:45:22,659 --> 04:45:23,727
THAT WAS NOT THE PROBLEM.

7117
04:45:23,727 --> 04:45:25,495
THE PROBLEM WAS SHE GAINED IT

7118
04:45:25,495 --> 04:45:25,929
BACK.

7119
04:45:25,929 --> 04:45:28,665
HER BIOLOGY WAS EXTREMELY

7120
04:45:28,665 --> 04:45:29,099
STRONG.

7121
04:45:29,099 --> 04:45:39,643
SO SHE WAS  EXTREMEL ADHERENT TO

7122
04:45:44,548 --> 04:45:46,516
DIET AND CAME TO US FOR HELP.

7123
04:45:46,516 --> 04:45:47,718
SHE ENCONTROLLED IN TRIALS.

7124
04:45:47,718 --> 04:45:52,022
THIS IS WHAT HAPPENED OVER THE

7125
04:45:52,022 --> 04:45:53,423
COURSE OF ONE YEAR.

7126
04:45:53,423 --> 04:45:56,126
WITHIN A YEAR SHE LOST OVER 90

7127
04:45:56,126 --> 04:45:58,462
POUNDS, CAME TO ME AND WAS SO

7128
04:45:58,462 --> 04:45:59,329
SURPRISED BECAUSE SHE SAID, YOU

7129
04:45:59,329 --> 04:46:00,430
KNOW, I'M DOING EVERYTHING THAT

7130
04:46:00,430 --> 04:46:03,066
I WAS DOING BEFORE I STARTED THE

7131
04:46:03,066 --> 04:46:04,401
TRIAL, TRACKING MY FOOD,

7132
04:46:04,401 --> 04:46:05,836
EXERCISING EVERY DAY, THE ONLY

7133
04:46:05,836 --> 04:46:08,972
THING THAT CHANGED IS MY WEIGHT.

7134
04:46:08,972 --> 04:46:11,275
SO TRULY THIS MEDICINE WAS

7135
04:46:11,275 --> 04:46:11,842
IMPACTING HER BIOLOGY, THE

7136
04:46:11,842 --> 04:46:14,745
BIOLOGY AND THE BRAIN YOU HEARD

7137
04:46:14,745 --> 04:46:15,679
ABOUT THIS MORNING.

7138
04:46:15,679 --> 04:46:18,482
WHAT HAPPENED WHEN SHE FINISHED

7139
04:46:18,482 --> 04:46:18,815
THE TRIAL?

7140
04:46:18,815 --> 04:46:20,250
WELL, UNFORTUNATELY SHE BEGAN TO

7141
04:46:20,250 --> 04:46:20,918
REGAIN WEIGHT.

7142
04:46:20,918 --> 04:46:22,853
WE DO SEE THIS.

7143
04:46:22,853 --> 04:46:25,022
THERE'S VARIABILITY BUT HER WAS

7144
04:46:25,022 --> 04:46:25,822
QUITE RAPID.

7145
04:46:25,822 --> 04:46:31,728
AND SO SHE CAME TO SEE ME IN

7146
04:46:31,728 --> 04:46:32,829
CLINIC, WE STARTED SEMAGLUTIDE

7147
04:46:32,829 --> 04:46:35,032
TO SLOW DOWN THE WEIGHT GAIN.

7148
04:46:35,032 --> 04:46:37,200
SHE WAS WAKING UP HUNGRY,

7149
04:46:37,200 --> 04:46:39,403
CRAVING, COULD NOT STOP HERSELF

7150
04:46:39,403 --> 04:46:41,838
FROM EATING SECONDS, THE PULL

7151
04:46:41,838 --> 04:46:44,474
WAS SO STRONG, SHE WAS

7152
04:46:44,474 --> 04:46:46,543
EXPERIENCING FOOD NOISE.

7153
04:46:46,543 --> 04:46:49,713
IT DID SLOW DOWN WAIT REGAIN,

7154
04:46:49,713 --> 04:46:50,814
MAINTAINED HALF OF WHAT SHE LOST

7155
04:46:50,814 --> 04:46:54,217
IN THE TRIAL AND HER BMI WAS

7156
04:46:54,217 --> 04:46:57,254
STILL CREEPING UP, ABOUT 28 TO

7157
04:46:57,254 --> 04:46:59,456
29, WE STARTED ONE OF THE OLDER

7158
04:46:59,456 --> 04:47:00,657
MEDICATIONS WHICH LEVELED HER

7159
04:47:00,657 --> 04:47:02,826
OUT, SHE STARTED TO LOSE WEIGHT

7160
04:47:02,826 --> 04:47:04,962
AGAIN. 

7161
04:47:04,962 --> 04:47:09,633
SO WHAT HAPPENED THEN IS IT WAS

7162
04:47:09,633 --> 04:47:10,634
COMMERCIALLY AVAILABLE, WHICH IT

7163
04:47:10,634 --> 04:47:11,935
WASN'T AT THE END OF THE TRIAL

7164
04:47:11,935 --> 04:47:18,608
BECAUSE THE FDA NEEDED TO REVIEW

7165
04:47:18,608 --> 04:47:19,710
DATA, WE TRANSITIONED AND

7166
04:47:19,710 --> 04:47:20,777
STOPPED SEMAGLUTIDE.

7167
04:47:20,777 --> 04:47:22,980
SHE CONTINUES, DOES NOT REQUIRE

7168
04:47:22,980 --> 04:47:25,282
HIGHEST DOSE, AND SHE'S DOING

7169
04:47:25,282 --> 04:47:29,753
QUITE WELL WITH BMI AROUND 25.

7170
04:47:29,753 --> 04:47:31,488
WHAT DOES SHE TEACH US?

7171
04:47:31,488 --> 04:47:33,690
SHE HAD TO MEET SPECIFIC

7172
04:47:33,690 --> 04:47:35,125
INCONTRIBUTION CRITERIA WHICH

7173
04:47:35,125 --> 04:47:36,994
SHE DID, AND SHE KNEW SHE HAD A

7174
04:47:36,994 --> 04:47:41,231
1 IN  4 CHANCE OF BEING ON

7175
04:47:41,231 --> 04:47:43,133
PLACEBO BUT WANTED TO ENROLL.

7176
04:47:43,133 --> 04:47:44,167
PROTOCOLIZED TREATMENT THIS IS

7177
04:47:44,167 --> 04:47:45,869
REALLY IMPORTANT, IF YOU NOTICED

7178
04:47:45,869 --> 04:47:47,304
HER WEIGHT TRAJECTORY IN TERMS

7179
04:47:47,304 --> 04:47:49,039
OF WEIGHT LOSS WAS VERY FAST,

7180
04:47:49,039 --> 04:47:50,941
SHE CAME DOWN TO BMI OF 20.

7181
04:47:50,941 --> 04:47:52,976
SHE DID NOT FEEL COMFORTABLE AT

7182
04:47:52,976 --> 04:47:54,578
A BMI OF 20 NOR DID SHE WANT TO

7183
04:47:54,578 --> 04:47:56,546
BE THERE BUT WAS SO COMMITTED TO

7184
04:47:56,546 --> 04:47:57,948
FINISHING THE TRIAL THAT SHE

7185
04:47:57,948 --> 04:47:59,549
DID.

7186
04:47:59,549 --> 04:48:01,785
SHE'S MUCH MORE COMFORTABLE, AND

7187
04:48:01,785 --> 04:48:04,087
FEELS HEALTHIER AT THIS BMI

7188
04:48:04,087 --> 04:48:07,591
WHERE SHE'S CURRENTLY.

7189
04:48:07,591 --> 04:48:08,892
AFTER THE TRIAL SHE SOUGHT

7190
04:48:08,892 --> 04:48:12,863
CLINICAL CARE WITH ME, WE

7191
04:48:12,863 --> 04:48:14,131
PRESENTED WEIGHT GAIN AND KEPT

7192
04:48:14,131 --> 04:48:16,333
HER TO A HEALTHY WEIGHT.

7193
04:48:16,333 --> 04:48:18,201
SHE ALSO HAD ACCESS AND

7194
04:48:18,201 --> 04:48:18,835
AVAILABILITY TO THESE THERAPIES

7195
04:48:18,835 --> 04:48:20,404
AND TOOK SOME TIME TO GET HER TO

7196
04:48:20,404 --> 04:48:22,472
WHAT HAD WORKED FOR HER IN THE

7197
04:48:22,472 --> 04:48:24,441
FIRST PLACE.

7198
04:48:24,441 --> 04:48:25,909
NOW, THE SECOND PATIENT,

7199
04:48:25,909 --> 04:48:27,277
39-YEAR-OLD, THAT I'VE SEEN FOR

7200
04:48:27,277 --> 04:48:28,578
ALMOST A DECADE NOW.

7201
04:48:28,578 --> 04:48:31,548
BEFORE SHE CAME TO SEE ME SHE

7202
04:48:31,548 --> 04:48:36,920
ACTUALLY HAD BARIATRIC SURGERY,

7203
04:48:36,920 --> 04:48:39,990
LOST 50 POUNDS, 20% OF HER BODY

7204
04:48:39,990 --> 04:48:40,223
WEIGHT.

7205
04:48:40,223 --> 04:48:41,224
UNFORTUNATELY SHE BEGAN TO

7206
04:48:41,224 --> 04:48:44,361
REGAIN WEIGHT AND MAY HAVE BEEN

7207
04:48:44,361 --> 04:48:46,963
DISEASE PROGRESSION OR OTHER

7208
04:48:46,963 --> 04:48:49,132
FACTORS AND REGAINED ABOUT 5%

7209
04:48:49,132 --> 04:48:50,500
QUICKLY BY 12 MONTHS OUT.

7210
04:48:50,500 --> 04:48:53,737
SHE ASKED HER CARE PROVIDER IF

7211
04:48:53,737 --> 04:48:55,305
SHE COULD START A MEDICATION, AT

7212
04:48:55,305 --> 04:48:58,375
THAT TIME NO MEDICATION WAS

7213
04:48:58,375 --> 04:49:06,249
STARTED, SEVERAL MONTH LATER

7214
04:49:06,249 --> 04:49:07,250
ASKED AGAIN, NALTREXONE

7215
04:49:07,250 --> 04:49:15,692
BIPRUPRPABE WAS STARTED.

7216
04:49:15,692 --> 04:49:18,995
WE CONTINUED, PLATEAUED, ADDED

7217
04:49:18,995 --> 04:49:23,166
PHENTERMINE, ADDED RECEPTOR

7218
04:49:23,166 --> 04:49:24,668
AGONIST, LOST WEIGHT, PLATEAUED,

7219
04:49:24,668 --> 04:49:26,236
AN SEMAGLUTIDE BECAME AVAILABLE

7220
04:49:26,236 --> 04:49:27,737
AND WE SWITCHED OUT FOR

7221
04:49:27,737 --> 04:49:29,940
SEMAGLUTIDE AND SHE CONTINUED TO

7222
04:49:29,940 --> 04:49:32,008
LOSE WEIGHT, DID EXPERIENCE SIDE

7223
04:49:32,008 --> 04:49:36,746
EFFECTS, WE DIDN'T TITRATE,

7224
04:49:36,746 --> 04:49:40,083
ADDED METFORMIN, LOST MORE

7225
04:49:40,083 --> 04:49:41,985
WEIGHT, PLATEAUED AGAIN, G.I.

7226
04:49:41,985 --> 04:49:51,394
SIDE EFFECTS  RESOLVED, CONTINUD

7227
04:49:51,394 --> 04:49:53,130
TO TITRATE SEMAGLUTIDE.

7228
04:49:53,130 --> 04:49:54,898
SHE LOST 75 ADDITIONAL POUNDS,

7229
04:49:54,898 --> 04:49:57,834
WITH SURGERY AND MEDICATION LOST

7230
04:49:57,834 --> 04:49:58,835
OVER 100 POUNDS.

7231
04:49:58,835 --> 04:50:00,804
ONCE WE WERE ABLE TO TITRATE UP

7232
04:50:00,804 --> 04:50:05,408
THE SEMAGLUTIDE WE WERE ABLE TO

7233
04:50:05,408 --> 04:50:07,477
STOP THE PHENTERMINE, AND THE

7234
04:50:07,477 --> 04:50:09,646
OTHERS, SHE REMAINS ON

7235
04:50:09,646 --> 04:50:10,046
SEMAGLUTIDE TODAY.

7236
04:50:10,046 --> 04:50:11,748
I SHARED THIS PATIENT WITH YOU

7237
04:50:11,748 --> 04:50:14,251
TO DEMONSTRATE THAT THINGS CAN

7238
04:50:14,251 --> 04:50:15,785
BE VERY COMPLICATED, AND THE

7239
04:50:15,785 --> 04:50:17,654
PATIENTS THAT WE CARE FOR AND

7240
04:50:17,654 --> 04:50:20,357
TREAT AND BECOME PARTICIPANTS IN

7241
04:50:20,357 --> 04:50:21,057
OUR RANDOMIZED CONTROLLED TRIALS

7242
04:50:21,057 --> 04:50:22,359
ARE NOT LIKE THIS.

7243
04:50:22,359 --> 04:50:24,294
WE REALLY, REALLY NEED TO

7244
04:50:24,294 --> 04:50:25,662
UNDERSTAND HOW TO CARE FOR

7245
04:50:25,662 --> 04:50:27,531
PATIENTS THAT RECEIVE THIS TYPE

7246
04:50:27,531 --> 04:50:28,798
OF REAL WORLD CARE.

7247
04:50:28,798 --> 04:50:31,334
SO, WHAT HAPPENS IN THE REAL

7248
04:50:31,334 --> 04:50:31,868
WORLD?

7249
04:50:31,868 --> 04:50:33,970
WE USE COMBINATION THERAPY,

7250
04:50:33,970 --> 04:50:35,272
WHETHER MEDICATION COMBINATION

7251
04:50:35,272 --> 04:50:38,008
THERAPY OR WITH SURGERY.

7252
04:50:38,008 --> 04:50:38,808
PATIENTS EXPERIENCE INSURANCE

7253
04:50:38,808 --> 04:50:40,777
BARRIERS, SHE WAS FORTUNATE TO

7254
04:50:40,777 --> 04:50:42,946
HAVE THE INSURANCE COVERAGE.

7255
04:50:42,946 --> 04:50:44,347
WE USE OLDER MEDICATIONS, THOSE

7256
04:50:44,347 --> 04:50:47,417
CAN OFTEN BE COST EFFECTIVE.

7257
04:50:47,417 --> 04:50:49,152
THERE IS MEDICATION INITIATION

7258
04:50:49,152 --> 04:50:49,819
AND DISCONTINUATION, I'LL TOUCH

7259
04:50:49,819 --> 04:50:52,556
ON THAT IN JUST A SECOND.

7260
04:50:52,556 --> 04:50:53,423
THERE'S DISEASE PROGRESSION, SO

7261
04:50:53,423 --> 04:50:55,692
JUST AS IN DIABETES WE ADD

7262
04:50:55,692 --> 04:50:56,560
MEDICATIONS, WE SHOULDN'T BE

7263
04:50:56,560 --> 04:50:58,828
SURPRISED THAT WE NEED TO ADD

7264
04:50:58,828 --> 04:50:59,462
MEDICATIONS OVER LONG-TERM

7265
04:50:59,462 --> 04:51:01,765
FOLLOW-UP AND CARE OF THESE

7266
04:51:01,765 --> 04:51:02,032
PATIENTS.

7267
04:51:02,032 --> 04:51:04,834
SO WHAT CAN WE LEARN FROM OUR

7268
04:51:04,834 --> 04:51:06,503
PATIENTS AND WHAT CAN REAL WORLD

7269
04:51:06,503 --> 04:51:09,639
STUDIES REALLY HELP US TO DO?

7270
04:51:09,639 --> 04:51:10,874
OF COURSE LONG-TERM

7271
04:51:10,874 --> 04:51:11,942
TOLERABILITY, SAFETY, EFFICACY

7272
04:51:11,942 --> 04:51:14,344
IS KEY, REALLY WHAT WE WANT TO

7273
04:51:14,344 --> 04:51:14,578
ADDRESS.

7274
04:51:14,578 --> 04:51:16,313
THERE'S MANY THINGS WITHIN THAT,

7275
04:51:16,313 --> 04:51:18,748
SO LOOKING AT EXTERNAL BARRIERS,

7276
04:51:18,748 --> 04:51:19,950
HOW THEY IMPACT BOTH TREATMENT

7277
04:51:19,950 --> 04:51:22,385
AS WELL AS LET OUTCOMES IN OUR

7278
04:51:22,385 --> 04:51:23,687
PATIENTS WHICH HAS COME UP

7279
04:51:23,687 --> 04:51:24,120
TODAY.

7280
04:51:24,120 --> 04:51:25,889
IN TERMS OF SIDE EFFECTS I WANT

7281
04:51:25,889 --> 04:51:28,058
TO SPEND A MOMENT ON THIS.

7282
04:51:28,058 --> 04:51:31,127
THIS IS BECAUSE IN THE TRIALS,

7283
04:51:31,127 --> 04:51:33,863
THE MEDICATIONS ARE TITRATED UP

7284
04:51:33,863 --> 04:51:36,066
ON A VERY CONCRETE SCHEDULE,

7285
04:51:36,066 --> 04:51:38,001
THERE'S SOME FLEXIBILITY IN

7286
04:51:38,001 --> 04:51:40,870
TRIALS, NOW, BUT IT IS MUCH MORE

7287
04:51:40,870 --> 04:51:42,639
FLEXIBLE IN REAL WORLD.

7288
04:51:42,639 --> 04:51:53,116
MOST COMMON SIDE EFFECTS ARE

7289
04:51:54,951 --> 04:51:55,285
GASTROINTESTINAL.

7290
04:51:55,285 --> 04:51:56,953
IF SOMEBODY IS HAVING NAUSEA WE

7291
04:51:56,953 --> 04:52:00,357
DON'T GO UP, IF THEY HAVE VOMIT

7292
04:52:00,357 --> 04:52:01,791
WE GO GO DOWN.

7293
04:52:01,791 --> 04:52:03,159
THERE'S NO REQUIREMENT TO GO UP

7294
04:52:03,159 --> 04:52:06,162
ONCE A MONTH ON THE DOSE,

7295
04:52:06,162 --> 04:52:08,765
STARTING LOW AND GOING SLOW CAN

7296
04:52:08,765 --> 04:52:09,032
MITIGATE.

7297
04:52:09,032 --> 04:52:11,301
DEPENDING ON PROVIDER OR

7298
04:52:11,301 --> 04:52:13,603
SETTING, DEPENDING HOW QUICKLY

7299
04:52:13,603 --> 04:52:15,705
THE MEDICATION IS TITRATED THIS

7300
04:52:15,705 --> 04:52:16,539
WILL IMPACT YOUR SIDE EFFECTS,

7301
04:52:16,539 --> 04:52:18,074
WE HAVE NO IDEA HOW THAT OCCURS

7302
04:52:18,074 --> 04:52:20,377
IN THE REAL WORLD.

7303
04:52:20,377 --> 04:52:22,379
THERE'S ALSO STRATEGIES FOR

7304
04:52:22,379 --> 04:52:23,113
PATIENTS, DIETARY STRATEGIES

7305
04:52:23,113 --> 04:52:25,282
THEY CAN EMPLOY THAT I LISTED

7306
04:52:25,282 --> 04:52:25,682
OUT.

7307
04:52:25,682 --> 04:52:27,917
THERE'S VERY FEW STUDIES LOOKING

7308
04:52:27,917 --> 04:52:29,886
AT HOW NUTRITION AND PHYSICAL

7309
04:52:29,886 --> 04:52:32,389
ACTIVITY CAN BE PAIRED WITH

7310
04:52:32,389 --> 04:52:34,591
THESE MEDICATIONS TO OPTIMIZE

7311
04:52:34,591 --> 04:52:37,294
THOSE TOLERABILITIES AS WELL AS

7312
04:52:37,294 --> 04:52:38,194
HEALTH OUTCOMES.

7313
04:52:38,194 --> 04:52:43,099
NOW, WHAT ARE OTHER THINGS?

7314
04:52:43,099 --> 04:52:44,634
WHAT IMPACTS WEIGHT EFFICACY

7315
04:52:44,634 --> 04:52:46,169
RESPONSE AND MAINTENANCE, WHAT

7316
04:52:46,169 --> 04:52:48,171
ARE IMPACTS?

7317
04:52:48,171 --> 04:52:49,039
WHAT IMPACTS LONG-TERM

7318
04:52:49,039 --> 04:52:50,040
ADHERENCE?

7319
04:52:50,040 --> 04:52:52,208
IN TERMS OF ADHERENCE THIS HAS

7320
04:52:52,208 --> 04:52:53,610
COME UP TODAY, ALSO VERY

7321
04:52:53,610 --> 04:52:54,044
IMPORTANT.

7322
04:52:54,044 --> 04:52:57,247
WE SEE THAT COST OF COURSE IS A

7323
04:52:57,247 --> 04:52:57,814
VERY SIGNIFICANT BARRIER,

7324
04:52:57,814 --> 04:53:01,384
ACCESS, DO YOU HAVE ACCESS TO

7325
04:53:01,384 --> 04:53:02,152
PROVIDERS, TOLERABILITY I JUST

7326
04:53:02,152 --> 04:53:03,453
MENTIONED, THAT WILL IMPROVE

7327
04:53:03,453 --> 04:53:04,354
OVER TIME.

7328
04:53:04,354 --> 04:53:05,989
THE LACK OF UNDERSTANDING OF THE

7329
04:53:05,989 --> 04:53:06,956
BIOLOGY OF OBESITY.

7330
04:53:06,956 --> 04:53:09,059
SO THE MOST COMMON QUESTION WE

7331
04:53:09,059 --> 04:53:10,560
GET FROM PATIENTS, I LOST

7332
04:53:10,560 --> 04:53:12,662
WEIGHT, I CAN STOP THE MEDICINE?

7333
04:53:12,662 --> 04:53:13,963
AND IT'S INTERESTING BECAUSE FOR

7334
04:53:13,963 --> 04:53:15,131
BLOOD PRESSURE OUR PATIENTS MAY

7335
04:53:15,131 --> 04:53:17,033
STOP THE MEDICINE BUT THEY DON'T

7336
04:53:17,033 --> 04:53:20,203
GENERALLY ASK US THIS QUESTION.

7337
04:53:20,203 --> 04:53:22,739
SO IF A MEDICATION IS STOPPED

7338
04:53:22,739 --> 04:53:23,907
FOR HIGHER TENSION, BLOOD

7339
04:53:23,907 --> 04:53:25,008
PRESSURE GOES UP, WE'RE NOT

7340
04:53:25,008 --> 04:53:25,408
SURPRISED.

7341
04:53:25,408 --> 04:53:27,544
BUT THEN WHEN WE SHOW THE SAME

7342
04:53:27,544 --> 04:53:29,512
EXACT FIGURE FOR OBESITY, WE

7343
04:53:29,512 --> 04:53:31,481
STOP THE MEDICINE, WE'RE

7344
04:53:31,481 --> 04:53:32,582
SURPRISED WHEN OUR PATIENTS MAY

7345
04:53:32,582 --> 04:53:35,218
GAIN BACK THE WEIGHT.

7346
04:53:35,218 --> 04:53:36,753
IF MEDICATIONS ARE IMPACTING

7347
04:53:36,753 --> 04:53:37,821
NEUROBIOLOGY OF THE DISEASE,

7348
04:53:37,821 --> 04:53:40,123
THEN WE STOP TREATING THAT

7349
04:53:40,123 --> 04:53:41,424
DISEASE, WHY WOULD WE BE

7350
04:53:41,424 --> 04:53:44,527
SURPRISED THE WEIGHT IS

7351
04:53:44,527 --> 04:53:44,794
REGAINED?

7352
04:53:44,794 --> 04:53:47,030
AS THERE'S VARIABILITY IN WEIGHT

7353
04:53:47,030 --> 04:53:48,098
REDUCTION, THERE'S ALSO

7354
04:53:48,098 --> 04:53:49,466
VARIABILITY IN WEIGHT REGAINED.

7355
04:53:49,466 --> 04:53:51,067
THAT'S BECAUSE THERE'S DIFFERENT

7356
04:53:51,067 --> 04:53:53,336
TYPES OF OBESITIES, WE NEED TO

7357
04:53:53,336 --> 04:53:54,471
UNDERSTAND THAT BUT ON AVERAGE

7358
04:53:54,471 --> 04:53:55,905
OVER TIME PATIENTS TEND TO GAIN

7359
04:53:55,905 --> 04:53:56,740
BACK THE WEIGHT.

7360
04:53:56,740 --> 04:54:00,910
WHAT ABOUT IF WE CONTINUE THE

7361
04:54:00,910 --> 04:54:01,378
MEDICATION?

7362
04:54:01,378 --> 04:54:04,881
HERE'S A THREE-YEAR RCT WE DID,

7363
04:54:04,881 --> 04:54:07,083
OVER THREE YEARS THE WEIGHT IS

7364
04:54:07,083 --> 04:54:08,618
ACHIEVED AND MAINTAINED, YOU CAN

7365
04:54:08,618 --> 04:54:10,820
ALSO SEE THIS WITH OTHER HEALTH

7366
04:54:10,820 --> 04:54:13,323
BENEFITS, HERE I'M SHOWING

7367
04:54:13,323 --> 04:54:21,765
SYSTOLIC BLOOD PRESSURE, SAME

7368
04:54:21,765 --> 04:54:22,532
SAID FOR A1c.

7369
04:54:22,532 --> 04:54:25,034
WHAT IN THE MEDICATION IS

7370
04:54:25,034 --> 04:54:26,035
DISCONTINUED?

7371
04:54:26,035 --> 04:54:27,771
WEIGHT REGAIN ON AVERAGE THERE'S

7372
04:54:27,771 --> 04:54:29,539
WEIGHT REGAINED WHEN MEDICATION

7373
04:54:29,539 --> 04:54:30,707
IS STOPPED, AGAIN THERE'S

7374
04:54:30,707 --> 04:54:31,708
VARIABILITY IN THAT.

7375
04:54:31,708 --> 04:54:33,543
WHAT WE REALLY NEED DO IS LOOK

7376
04:54:33,543 --> 04:54:36,179
AT THIS LONG TERM BECAUSE SOME

7377
04:54:36,179 --> 04:54:37,947
PATIENTS CAN SUSTAIN SHORT TERM,

7378
04:54:37,947 --> 04:54:39,349
BUT LONG TERM GAIN BACK.

7379
04:54:39,349 --> 04:54:41,851
SAME THING WITH BLOOD PRESSURE.

7380
04:54:41,851 --> 04:54:43,386
VERY QUICKLY THAT STARTS TO GO

7381
04:54:43,386 --> 04:54:44,187
BACK UP.

7382
04:54:44,187 --> 04:54:46,356
NOT ONLY ARE WE LOSING THE

7383
04:54:46,356 --> 04:54:48,858
WEIGHT BENEFIT, WE'RE ALSO

7384
04:54:48,858 --> 04:54:52,061
LOSING THE BLOOD PRESSURE A1C

7385
04:54:52,061 --> 04:54:52,362
BENEFIT.

7386
04:54:52,362 --> 04:54:53,696
WITH OBESITY, ADHERENCE COULD BE

7387
04:54:53,696 --> 04:54:54,464
A SECRET WEAPON.

7388
04:54:54,464 --> 04:54:56,466
THE REASON I SAY THIS IS BECAUSE

7389
04:54:56,466 --> 04:54:57,967
IF YOUR PATIENT STOPS TAKING

7390
04:54:57,967 --> 04:54:59,169
BLOOD PRESSURE MEDICINE THEY

7391
04:54:59,169 --> 04:55:00,203
DON'T HAVE ANY IMMEDIATE

7392
04:55:00,203 --> 04:55:01,337
FEEDBACK THAT THEIR BLOOD

7393
04:55:01,337 --> 04:55:03,306
PRESSURE IS GOING UP.

7394
04:55:03,306 --> 04:55:05,408
SAME THING WITH HEMOGLOBIN A1C.

7395
04:55:05,408 --> 04:55:07,277
IF A PATIENT SYMPTOMS TAKING

7396
04:55:07,277 --> 04:55:07,911
ANTI-OBESITY MEDICATION AND IS

7397
04:55:07,911 --> 04:55:09,746
THAT RIGHT GAINING BACK WEIGHT,

7398
04:55:09,746 --> 04:55:11,080
THEY CAN IMMEDIATELY FEEL THAT

7399
04:55:11,080 --> 04:55:13,149
AND SEE THAT.

7400
04:55:13,149 --> 04:55:15,351
SO, I THINK ADHERENCE LONG TERM

7401
04:55:15,351 --> 04:55:17,754
ONCE WE ADDRESS COST AND ACCESS

7402
04:55:17,754 --> 04:55:19,189
WILL ACTUALLY BE A SECRET WEAPON

7403
04:55:19,189 --> 04:55:20,323
AND HOPEFULLY PATIENTS WILL COME

7404
04:55:20,323 --> 04:55:22,125
BACK TO YOUS, MOST OF MY

7405
04:55:22,125 --> 04:55:24,327
PATIENTS IF THEY STOP, THEY STOP

7406
04:55:24,327 --> 04:55:26,162
ONCE AND NEVER AGAIN.

7407
04:55:26,162 --> 04:55:27,697
SO, WHAT ARE A FEW OTHER THINGS?

7408
04:55:27,697 --> 04:55:29,799
WHAT ARE THE LONG-TERM SAFETY

7409
04:55:29,799 --> 04:55:30,767
OUTCOMES?

7410
04:55:30,767 --> 04:55:33,937
THIS IS REALLY KEY IN TERMS OF

7411
04:55:33,937 --> 04:55:35,271
DECADES OF DATA, NOT YEARS OF

7412
04:55:35,271 --> 04:55:37,173
DATA, AND WE DO HAVE THAT IN

7413
04:55:37,173 --> 04:55:38,741
PATIENTS WITH DIABETES IN TERMS

7414
04:55:38,741 --> 04:55:41,444
OF USE OF THESE MEDICATIONS BUT

7415
04:55:41,444 --> 04:55:42,579
NOT WITH OBESITY.

7416
04:55:42,579 --> 04:55:44,714
WHAT ARE THE POTENTIAL

7417
04:55:44,714 --> 04:55:45,648
ADDITIONAL EFFECTS?

7418
04:55:45,648 --> 04:55:47,050
WHAT ARE PATIENTS EXPERIENCING?

7419
04:55:47,050 --> 04:55:48,051
HOW IS THIS IMPACTING THEIR

7420
04:55:48,051 --> 04:55:49,486
QUALITY OF LIFE?

7421
04:55:49,486 --> 04:55:51,221
THIS IS ALL IMPORTANT, ONLY WAY

7422
04:55:51,221 --> 04:55:53,623
WE'LL KNOW THAT IF WE'RE GOING

7423
04:55:53,623 --> 04:55:55,525
TO ACTIVELY INCLUDE PATIENTS IN

7424
04:55:55,525 --> 04:56:01,197
THESE TRIALS IN TERMS, IN THESE

7425
04:56:01,197 --> 04:56:02,699
STUDIES WHAT WE'RE ADDRESSING

7426
04:56:02,699 --> 04:56:03,366
AND ACTING.

7427
04:56:03,366 --> 04:56:05,034
WHAT IS THE IMPACT OF PATIENT

7428
04:56:05,034 --> 04:56:06,436
CARE SETTING, PLACE THEY ARE

7429
04:56:06,436 --> 04:56:10,607
RECEIVING CARE AND WHAT IS BEING

7430
04:56:10,607 --> 04:56:10,974
DELIVERED THERE?

7431
04:56:10,974 --> 04:56:14,444
AND WHAT ROLE DOES SHARED

7432
04:56:14,444 --> 04:56:14,911
DECISION MAKING PLAY?

7433
04:56:14,911 --> 04:56:15,545
THIS IS IMPORTANT BECAUSE SO

7434
04:56:15,545 --> 04:56:17,280
MUCH OF THE TIME OUR PATIENTS

7435
04:56:17,280 --> 04:56:19,582
COME TO US ASKING FOR SPECIFIC

7436
04:56:19,582 --> 04:56:20,450
MEDICATION BECAUSE OF EVERYTHING

7437
04:56:20,450 --> 04:56:22,318
THEY HAVE SEEN ON SOCIAL MEDIA.

7438
04:56:22,318 --> 04:56:23,853
AND ALL OF THIS IS IMPORTANT

7439
04:56:23,853 --> 04:56:26,589
BECAUSE HOW DO WE BEST INFORM

7440
04:56:26,589 --> 04:56:27,991
STANDARDS OF CARE AND OPTIMIZED

7441
04:56:27,991 --> 04:56:28,558
HEALTH OUTCOMES?

7442
04:56:28,558 --> 04:56:31,961
I COME BACK TO OUR PATIENT, WITH

7443
04:56:31,961 --> 04:56:33,496
OBESITY, THAT PERSON THAT CAN

7444
04:56:33,496 --> 04:56:34,797
TEACH US EVERYTHING THAT WE NEED

7445
04:56:34,797 --> 04:56:36,566
TO KNOW, IDENTIFY THOSE GAPS,

7446
04:56:36,566 --> 04:56:37,867
GIVE US THE QUESTIONS, ALL WE

7447
04:56:37,867 --> 04:56:40,603
NEED TO DO IS FIGURE OUT HOW TO

7448
04:56:40,603 --> 04:56:41,571
ANSWER THOSE QUESTIONS.

7449
04:56:41,571 --> 04:56:43,973
SO WITH THAT I THINK THANK YOU

7450
04:56:43,973 --> 04:56:45,408
FOR YOUR ATTENTION AND I'LL HAND

7451
04:56:45,408 --> 04:56:48,378
IT OVER TO DR. CURTIS.

7452
04:56:48,378 --> 04:56:50,346
THANK YOU.

7453
04:56:50,346 --> 04:56:51,314
>> THANK YOU.

7454
04:56:51,314 --> 04:56:54,484
IT SET US UP WELL FOR THE NEXT

7455
04:56:54,484 --> 04:56:57,787
PRESENTATION BY DR. LESLEY

7456
04:56:57,787 --> 04:56:58,421
CURTIS.

7457
04:56:58,421 --> 04:57:00,957
SO, I WILL BRIEFLY THROUGH DR.

7458
04:57:00,957 --> 04:57:03,359
CURTIS, WHAT WEARS MANY HATS.

7459
04:57:03,359 --> 04:57:05,562
DR. CURTIS IS CURRENTLY CHAIR

7460
04:57:05,562 --> 04:57:07,263
AND PROFESSOR IN THE DEPARTMENT

7461
04:57:07,263 --> 04:57:11,234
OF  DEPARTMENT

7462
04:57:11,234 --> 04:57:14,370
OF POPULATION HEALTH SCIENCE AND

7463
04:57:14,370 --> 04:57:16,039
MEDICINE AT DUKE.

7464
04:57:16,039 --> 04:57:17,340
CO-CHAIR OF THE WORKSHOP TODAY

7465
04:57:17,340 --> 04:57:18,675
AND WILL TALK ABOUT

7466
04:57:18,675 --> 04:57:21,277
OPPORTUNITIES AND CHALLENGES OF

7467
04:57:21,277 --> 04:57:25,014
USING PRAGMATIC TRIALS TO STUDY

7468
04:57:25,014 --> 04:57:25,882
GLP-1-BASED THERAPIES.

7469
04:57:25,882 --> 04:57:26,215
LESLEY?

7470
04:57:26,215 --> 04:57:31,487
>>  THANKS SO MUCH,
DARREN.

7471
04:57:31,487 --> 04:57:32,889
THANK YOU, ANIA, FOR SETTING

7472
04:57:32,889 --> 04:57:34,891
THIS TALK UP SO WELL.

7473
04:57:34,891 --> 04:57:37,293
FIRST OF ALL, MY DISCLOSURES, I

7474
04:57:37,293 --> 04:57:38,695
WANT TO SHARE THOSE.

7475
04:57:38,695 --> 04:57:42,165
WHAT I'LL BE TALKING ABOUT TODAY

7476
04:57:42,165 --> 04:57:43,933
THAT IS PRAGMATIC CLINICAL

7477
04:57:43,933 --> 04:57:45,602
TRIALS REALLY COMES FROM THE TEN

7478
04:57:45,602 --> 04:57:49,505
YEARS OR SO THAT I HAVE SPENT

7479
04:57:49,505 --> 04:57:51,274
WORKING IN THE NIH PRAGMATIC

7480
04:57:51,274 --> 04:57:52,075
TRIALS COLLABORATORY.

7481
04:57:52,075 --> 04:57:55,979
SO, FOR THOSE WHO MAY NOT BE

7482
04:57:55,979 --> 04:57:58,715
FAMILIAR WITH THE COLLABORATORY,

7483
04:57:58,715 --> 04:58:01,250
IT'S A GROUP OF ABOUT -- WE NOW

7484
04:58:01,250 --> 04:58:05,254
HAVE MAYBE 35 TRIALS THAT HAVE

7485
04:58:05,254 --> 04:58:06,589
EITHER BEEN PART OF THE

7486
04:58:06,589 --> 04:58:08,691
COLLABORATORY OR PART OF THE

7487
04:58:08,691 --> 04:58:09,859
COLLABORATORY PRAGMATIC TRIALS

7488
04:58:09,859 --> 04:58:12,695
THAT COME TOGETHER TO LEARN HOW

7489
04:58:12,695 --> 04:58:15,098
BEST TO DO PRAGMATIC TRIALS

7490
04:58:15,098 --> 04:58:16,799
EMBEDDED IN HEALTH CARE

7491
04:58:16,799 --> 04:58:17,333
DELIVERY.

7492
04:58:17,333 --> 04:58:20,036
THESE 35 TRIALS HAVE BEEN FUNDED

7493
04:58:20,036 --> 04:58:24,340
BY 14 I.C.s ACROSS THE NIH,

7494
04:58:24,340 --> 04:58:26,843
AND HAVE GENERATED JUST RICH,

7495
04:58:26,843 --> 04:58:28,177
RICH LESSONS ABOUT HOW BEST TO

7496
04:58:28,177 --> 04:58:29,245
DO PRAGMATIC TRIALS.

7497
04:58:29,245 --> 04:58:31,581
SO WHAT I'LL TALK ABOUT AT LEAST

7498
04:58:31,581 --> 04:58:33,216
IN THE FIRST PART REALLY

7499
04:58:33,216 --> 04:58:36,419
REFLECTS WHAT WE'VE LEARNED

7500
04:58:36,419 --> 04:58:37,053
TOGETHER.

7501
04:58:37,053 --> 04:58:38,721
IT'S HELPFUL TO THINK ABOUT

7502
04:58:38,721 --> 04:58:41,457
PRAGMATIC TRIALS IN TERMS OF

7503
04:58:41,457 --> 04:58:43,192
THREE KEY ATTRIBUTES.

7504
04:58:43,192 --> 04:58:47,063
THE FIRST IS THAT THE INTENT IS

7505
04:58:47,063 --> 04:58:48,931
ALMOST ALWAYS TO INFORM DECISION

7506
04:58:48,931 --> 04:58:52,402
MAKERS, AND THAT INCLUDES

7507
04:58:52,402 --> 04:58:52,935
PATIENTS, CLINICIANS,

7508
04:58:52,935 --> 04:58:54,170
POLICYMAKERS, PAYERS, MANY OF

7509
04:58:54,170 --> 04:58:57,674
WHOM WE'VE HEARD FROM TODAY.

7510
04:58:57,674 --> 04:59:01,577
IT'S NOT TO ELUCIDATE BIOLOGICAL

7511
04:59:01,577 --> 04:59:03,246
OR SOCIAL MECHANISMS.

7512
04:59:03,246 --> 04:59:05,648
THESE TRIALS ALSO AIM TO ENROLL

7513
04:59:05,648 --> 04:59:08,051
A POPULATION THAT'S REALLY

7514
04:59:08,051 --> 04:59:11,320
RELEVANT TO THE DECISION, AND

7515
04:59:11,320 --> 04:59:12,955
THAT DECISION IN CLINICAL

7516
04:59:12,955 --> 04:59:13,356
PRACTICE.

7517
04:59:13,356 --> 04:59:16,359
WE ALSO LOOK FOR THEM TO BE

7518
04:59:16,359 --> 04:59:17,894
REPRESENTATIVE OF BOTH THE

7519
04:59:17,894 --> 04:59:19,662
PATIENTS AND SETTINGS IN WHOM

7520
04:59:19,662 --> 04:59:22,398
THAT DECISION IS RELEVANT.

7521
04:59:22,398 --> 04:59:24,033
AND THEN FINALLY, A KEY

7522
04:59:24,033 --> 04:59:27,437
ATTRIBUTE IS JUST THE INTENT TO

7523
04:59:27,437 --> 04:59:28,404
REALLY SIMPLIFY PROCEDURES AND

7524
04:59:28,404 --> 04:59:31,240
DATA COLLECTION, SO THAT THE

7525
04:59:31,240 --> 04:59:33,876
TRIAL CAN FOCUS ON THE POWER

7526
04:59:33,876 --> 04:59:35,311
NEEDED TO ANSWER THE QUESTION,

7527
04:59:35,311 --> 04:59:39,115
ACROSS A BROAD RANGE OF

7528
04:59:39,115 --> 04:59:39,382
OUTCOMES.

7529
04:59:39,382 --> 04:59:42,618
NOW, YOU KNOW, WHEN WE THINK

7530
04:59:42,618 --> 04:59:43,920
ABOUT PRAGMATIC TRIALS, IT'S

7531
04:59:43,920 --> 04:59:46,222
REALLY IMPORTANT TO REMEMBER

7532
04:59:46,222 --> 04:59:47,657
THAT PRAGMATISM IS SOMETHING

7533
04:59:47,657 --> 04:59:50,059
THAT OPERATES ALONG A SPECTRUM.

7534
04:59:50,059 --> 04:59:54,831
THESE I SHOW HERE ON THIS

7535
04:59:54,831 --> 04:59:57,500
FIGURE, ELEMENTS OF THE PRESSIE

7536
04:59:57,500 --> 05:00:00,703
2 FRAMEWORK FOR EVALUATION OR

7537
05:00:00,703 --> 05:00:02,438
ASSESSING PRAGMATISM OF A TRIAL.

7538
05:00:02,438 --> 05:00:05,374
FOR THOSE FAMILIAR WITH IT

7539
05:00:05,374 --> 05:00:07,009
YOU'LL RECOGNIZE WE OFTEN THINK

7540
05:00:07,009 --> 05:00:10,880
ABOUT THAT IN TERMS OF

7541
05:00:10,880 --> 05:00:13,082
ELIGIBILITY, HOW WIDELY

7542
05:00:13,082 --> 05:00:14,283
AVAILABLE OR HOW ELIGIBLE, WHAT

7543
05:00:14,283 --> 05:00:16,586
DOES THE POPULATION LOOK LIKE IN

7544
05:00:16,586 --> 05:00:17,987
TERMS OF ELIGIBILITY, HOW

7545
05:00:17,987 --> 05:00:20,656
RESTRICTIVE ARE WE WITH

7546
05:00:20,656 --> 05:00:22,792
ELIGIBILITY CRITERIA, ARE WE

7547
05:00:22,792 --> 05:00:24,026
RECRUITING IN PRAGMATIC TRIALS,

7548
05:00:24,026 --> 05:00:25,762
WE COULD RECRUIT IN THE CARE

7549
05:00:25,762 --> 05:00:28,664
SETTING IN WHICH THE PATIENTS

7550
05:00:28,664 --> 05:00:30,900
ARE ACTUALLY SEEN.

7551
05:00:30,900 --> 05:00:33,336
YOU KNOW, THE SETTING MIGHT ALSO

7552
05:00:33,336 --> 05:00:35,938
BE A PRIMARY CARE PHYSICIANS

7553
05:00:35,938 --> 05:00:38,241
PRACTICE, RATHER THAN, SAY,

7554
05:00:38,241 --> 05:00:38,875
SPECIALTY CLINIC.

7555
05:00:38,875 --> 05:00:43,045
WE OFTEN HAVE TO THINK ABOUT THE

7556
05:00:43,045 --> 05:00:45,047
RESOURCES REQUIRED AT THE

7557
05:00:45,047 --> 05:00:45,982
ORGANIZATIONAL LEVEL TO SUPPORT

7558
05:00:45,982 --> 05:00:48,284
AND EXECUTE THE TRIAL.

7559
05:00:48,284 --> 05:00:52,321
SO WE'RE TALKING ABOUT CHANGING

7560
05:00:52,321 --> 05:00:53,556
CLINICAL WORKFLOWS MUCH LESS

7561
05:00:53,556 --> 05:00:55,424
PRAGMATIC THAN SOMETHING THAT

7562
05:00:55,424 --> 05:01:02,331
HAS A VERY LIGHT TOUCH.

7563
05:01:02,331 --> 05:01:03,299
OTHER CONSIDERATIONS WITH

7564
05:01:03,299 --> 05:01:04,400
RESPECT TO FLEXIBILITY OF

7565
05:01:04,400 --> 05:01:06,002
INTERVENTION AND HOW FLEXIBLE WE

7566
05:01:06,002 --> 05:01:10,740
ARE WITH ADHERENCE TO THE

7567
05:01:10,740 --> 05:01:11,073
INTERVENTION.

7568
05:01:11,073 --> 05:01:13,676
HOW WE'RE FOLLOWING UP THE

7569
05:01:13,676 --> 05:01:15,211
PARTICIPANTS, WHETHER THE

7570
05:01:15,211 --> 05:01:16,979
OUTCOMES ARE SURROGATE OUTCOMES,

7571
05:01:16,979 --> 05:01:20,283
WHICH ARE USED IN EXPLANATORY

7572
05:01:20,283 --> 05:01:23,319
TRIALS, OR PATIENT FOCUSED.

7573
05:01:23,319 --> 05:01:25,955
THE KEY THING TO REMEMBER HERE

7574
05:01:25,955 --> 05:01:28,658
IS THAT PRAGMATIC IS AN

7575
05:01:28,658 --> 05:01:33,396
ADJECTIVE BUT NOT A BINARY

7576
05:01:33,396 --> 05:01:35,398
INDICATOR OF THE TRIAL.

7577
05:01:35,398 --> 05:01:36,899
YOU KNOW, AGAIN, WE CONDUCT

7578
05:01:36,899 --> 05:01:39,869
THESE BECAUSE THEY HAVE SUCH

7579
05:01:39,869 --> 05:01:41,871
POTENTIAL TO INFORM POLICY AND

7580
05:01:41,871 --> 05:01:43,806
PRACTICE WITH TRULY HIGH QUALITY

7581
05:01:43,806 --> 05:01:44,140
EVIDENCE.

7582
05:01:44,140 --> 05:01:48,311
AND OFTEN WE CAN DO IT AT A

7583
05:01:48,311 --> 05:01:49,378
REDUCED COST WITH HIGHER

7584
05:01:49,378 --> 05:01:52,682
EFFICIENCY COMPARED TO A

7585
05:01:52,682 --> 05:01:54,183
TRADITIONAL TRIAL.

7586
05:01:54,183 --> 05:01:55,718
IN THE COLLABORATORY WE'VE COME

7587
05:01:55,718 --> 05:01:58,454
UP WITH THE FIVE Rs THAT

7588
05:01:58,454 --> 05:02:00,623
EXPLAIN WHY WE WOULD DO A PCT.

7589
05:02:00,623 --> 05:02:03,159
I'VE TOUCHED ON SOME OF THESE ON

7590
05:02:03,159 --> 05:02:05,127
THE EARLIER SLIDES, BUT I THINK

7591
05:02:05,127 --> 05:02:06,295
IT REALLY STARTS WITH THE

7592
05:02:06,295 --> 05:02:07,330
QUESTION, RIGHT?

7593
05:02:07,330 --> 05:02:09,398
THE QUESTION DICTATES WHETHER

7594
05:02:09,398 --> 05:02:11,467
WE'RE DOING A PRAGMATIC TRIAL OR

7595
05:02:11,467 --> 05:02:15,304
NOT, AND IT HAS TO BE A PRESSING

7596
05:02:15,304 --> 05:02:18,040
ONE THAT THE HEALTHCARE SYSTEM,

7597
05:02:18,040 --> 05:02:18,941
LEADERS, PATIENTS, FRONTLINE

7598
05:02:18,941 --> 05:02:20,109
CLINICIANS, WHERE THEY CARE

7599
05:02:20,109 --> 05:02:22,745
ABOUT THE ANSWER.

7600
05:02:22,745 --> 05:02:23,512
THAT'S IMPORTANT BECAUSE

7601
05:02:23,512 --> 05:02:26,449
PRAGMATIC TRIALS EVEN THE MOST

7602
05:02:26,449 --> 05:02:28,751
PRAGMATIC ONES OFTEN TOUCH THOSE

7603
05:02:28,751 --> 05:02:31,153
DIFFERENT STAKEHOLDERS AND THEIR

7604
05:02:31,153 --> 05:02:32,054
BUY-IN IS ESSENTIAL.

7605
05:02:32,054 --> 05:02:35,625
WE DO THEM BECAUSE WE WANT TO

7606
05:02:35,625 --> 05:02:38,060
TEST AN INTERVENTION IN A REAL

7607
05:02:38,060 --> 05:02:39,362
WORLD SETTING WHICH OF COURSE

7608
05:02:39,362 --> 05:02:41,898
WE'VE BEEN TALKING ABOUT ALL DAY

7609
05:02:41,898 --> 05:02:42,498
TODAY.

7610
05:02:42,498 --> 05:02:45,835
WE WANT TO MAKE SURE WE'RE

7611
05:02:45,835 --> 05:02:47,803
FOCUSED ON A REPRESENTATIVE

7612
05:02:47,803 --> 05:02:50,239
POPULATION, SO THAT THE RESULTS

7613
05:02:50,239 --> 05:02:54,810
OF THE TRIAL REALLY INFORM THE

7614
05:02:54,810 --> 05:02:56,279
IMPLEMENTATION MORE BROADLY THAN

7615
05:02:56,279 --> 05:02:57,446
IN THE TRIAL.

7616
05:02:57,446 --> 05:03:00,750
AND ACCELERATE UPTAKE OF

7617
05:03:00,750 --> 05:03:01,951
SUCCESSFUL INTERVENTIONS.

7618
05:03:01,951 --> 05:03:05,087
WE'RE OFTEN LOOKING TO RELY ON

7619
05:03:05,087 --> 05:03:05,855
ROUTINELY COLLECTED DATA

7620
05:03:05,855 --> 05:03:08,157
WHEREVER POSSIBLE.

7621
05:03:08,157 --> 05:03:10,693
AGAIN, TO MAXIMIZE EFFICIENCY,

7622
05:03:10,693 --> 05:03:12,528
AND MINIMIZE ADDITIONAL COST.

7623
05:03:12,528 --> 05:03:15,364
AND, YOU KNOW, PERHAPS THE MOST

7624
05:03:15,364 --> 05:03:19,101
IMPORTANT REASON TO DO A

7625
05:03:19,101 --> 05:03:21,604
PRAGMATIC TRIAL VERSUS OTHER

7626
05:03:21,604 --> 05:03:23,940
REAL WORLD APPROACHES IS BECAUSE

7627
05:03:23,940 --> 05:03:25,141
SOME QUESTIONS REALLY NEED

7628
05:03:25,141 --> 05:03:26,909
RANDOMIZATION IN ORDER FOR THEM

7629
05:03:26,909 --> 05:03:30,079
TO BE ANSWERED IN A WAY THAT

7630
05:03:30,079 --> 05:03:32,915
TRULY INFORMS THE DECISION

7631
05:03:32,915 --> 05:03:33,416
MAKER.

7632
05:03:33,416 --> 05:03:36,552
SO, WITH THAT KIND OF OVERVIEW

7633
05:03:36,552 --> 05:03:38,521
OF PRAGMATIC TRIALS, LET ME JUST

7634
05:03:38,521 --> 05:03:41,891
TOUCH ON A FEW CONSIDERATIONS

7635
05:03:41,891 --> 05:03:45,828
FOR PRAGMATIC TRIALS THAT WOULD

7636
05:03:45,828 --> 05:03:50,533
BE USING GLP-1 BASED THERAPIES.

7637
05:03:50,533 --> 05:03:53,269
FIRST, WITH RESPECT TO EQUIPOISE

7638
05:03:53,269 --> 05:03:55,037
AND RECRUITMENT, AND WE'VE HEARD

7639
05:03:55,037 --> 05:03:57,974
SOME ABOUT THIS TODAY ALREADY,

7640
05:03:57,974 --> 05:04:03,446
YOU KNOW, CONSIDER A TRIAL THAT

7641
05:04:03,446 --> 05:04:05,414
RANDOMIZES PATIENTS OR

7642
05:04:05,414 --> 05:04:08,351
PARTICIPANTS TO A GLP-1-BASED

7643
05:04:08,351 --> 05:04:10,987
THERAPY AND A NON-GLP-1 ARM,

7644
05:04:10,987 --> 05:04:14,924
GIVEN WHAT WE KNOW ABOUT THE

7645
05:04:14,924 --> 05:04:16,459
EFFICACY OF GLP-1-BASED

7646
05:04:16,459 --> 05:04:18,094
THERAPIES, YOU COULD IMAGINE

7647
05:04:18,094 --> 05:04:20,830
THAT CLINICIANS MIGHT REALLY BE

7648
05:04:20,830 --> 05:04:21,931
UNWILLING OR UNINTERESTED IN

7649
05:04:21,931 --> 05:04:25,534
REFERRING PATIENTS TO A TRIAL

7650
05:04:25,534 --> 05:04:29,005
WHERE THE RANDOMIZATION INCLUDES

7651
05:04:29,005 --> 05:04:30,473
THAT NON-GLP-1 ONE ARM.

7652
05:04:30,473 --> 05:04:33,309
HERE MAKES SENSE TO THINK ABOUT

7653
05:04:33,309 --> 05:04:35,277
WHERE COMPARATIVE EFFECTIVENESS

7654
05:04:35,277 --> 05:04:36,379
TRIALS OR HEAD-TO-HEAD TRIALS

7655
05:04:36,379 --> 05:04:38,447
COULD BE MORE LIKELY TO SUCCEED.

7656
05:04:38,447 --> 05:04:40,649
AND THAT MAY BE SOMETHING THAT

7657
05:04:40,649 --> 05:04:44,587
WE WILL TALK ABOUT TODAY.

7658
05:04:44,587 --> 05:04:47,957
ALSO IMPORTANT TO THINK ABOUT

7659
05:04:47,957 --> 05:04:48,824
THE PARTICIPANT PERSPECTIVE

7660
05:04:48,824 --> 05:04:50,693
HERE, AND THEY MIGHT BE

7661
05:04:50,693 --> 05:04:52,895
UNWILLING TO RISK BEING ASSIGNED

7662
05:04:52,895 --> 05:04:56,298
TO A COMPARATOR ARM, RIGHT?

7663
05:04:56,298 --> 05:04:57,500
SO, SOMETIMES THERE'S AN

7664
05:04:57,500 --> 05:04:59,135
ASSUMPTION OR OFTENTIMES THERE

7665
05:04:59,135 --> 05:05:01,337
MAY BE ASSUMPTION THAT TRIAL

7666
05:05:01,337 --> 05:05:02,538
PARTICIPATION GIVES THEM ACCESS

7667
05:05:02,538 --> 05:05:05,274
TO THE DRUG, WHEN IN FACT OF

7668
05:05:05,274 --> 05:05:08,978
COURSE THEY COULD BE RANDOMIZED

7669
05:05:08,978 --> 05:05:11,847
TO A DIFFERENT ARM.

7670
05:05:11,847 --> 05:05:13,716
I THINK A TAKEAWAY HERE,

7671
05:05:13,716 --> 05:05:15,384
SOMETHING WE'VE SEEN TIME AND

7672
05:05:15,384 --> 05:05:19,855
AGAIN IN THE COLLABORATORY, IS

7673
05:05:19,855 --> 05:05:20,756
THAT CLINICIAN AND PATIENT

7674
05:05:20,756 --> 05:05:22,058
ENGAGEMENT IN THE DESIGN IS

7675
05:05:22,058 --> 05:05:25,895
TRULY ESSENTIAL TO MAKE SURE

7676
05:05:25,895 --> 05:05:30,666
THAT THE TRIAL CAN BE

7677
05:05:30,666 --> 05:05:32,168
EFFECTIVELY UNDERTAKEN, PATIENTS

7678
05:05:32,168 --> 05:05:40,276
AND CLINICIANS WILL WANT TO

7679
05:05:40,276 --> 05:05:40,576
PARTICIPATE.

7680
05:05:40,576 --> 05:05:43,879
WE'VE HEARD TODAY ABOUT THE

7681
05:05:43,879 --> 05:05:45,548
RAPIDLY SHIFTING LANDSCAPE, DAVE

7682
05:05:45,548 --> 05:05:49,485
IN HIS FIRST TALK REALLY LAID

7683
05:05:49,485 --> 05:05:52,488
OUT NICELY HOW QUICKLY THE

7684
05:05:52,488 --> 05:05:54,090
LANDSCAPE HAS ACCELERATED OVER

7685
05:05:54,090 --> 05:05:57,493
THE LAST FEW YEARS EVEN.

7686
05:05:57,493 --> 05:06:00,463
THINK ABOUT A TRIAL THAT MIGHT

7687
05:06:00,463 --> 05:06:02,298
COMPARE A GLP-1-BASED THERAPY TO

7688
05:06:02,298 --> 05:06:07,336
SOME KIND OF USUAL CARE ARM.

7689
05:06:07,336 --> 05:06:09,071
WELL, THAT MAY NOT REPRESENT THE

7690
05:06:09,071 --> 05:06:15,010
STANDARD OF CARE AS THE TRIAL

7691
05:06:15,010 --> 05:06:15,311
PROGRESSES.

7692
05:06:15,311 --> 05:06:18,414
DOES LEAD US TO THINK ABOUT

7693
05:06:18,414 --> 05:06:20,382
ADAPTIVE OR PLATFORM DESIGNS

7694
05:06:20,382 --> 05:06:22,084
WITH FLEXIBILITY, ALSO GENERALLY

7695
05:06:22,084 --> 05:06:24,954
LESS PRAGMATIC AND A LITTLE BIT

7696
05:06:24,954 --> 05:06:28,290
MORE COMPLICATED, THESE ARE

7697
05:06:28,290 --> 05:06:28,924
CONSIDERATIONS, RIGHT?

7698
05:06:28,924 --> 05:06:30,126
THERE ARE CHALLENGES AND THERE

7699
05:06:30,126 --> 05:06:38,701
ARE SOLUTIONS BUT THEY DO ADD

7700
05:06:38,701 --> 05:06:39,368
SOME COMPLEXITY.

7701
05:06:39,368 --> 05:06:40,469
ECHOING PRIOR SLIDE IT'S

7702
05:06:40,469 --> 05:06:42,204
IMPORTANT TO INVOLVE PAYERS AND

7703
05:06:42,204 --> 05:06:46,041
REGULATORS EARLY TO MAKE SURE

7704
05:06:46,041 --> 05:06:48,644
THAT AGAIN WE'RE DEFINING

7705
05:06:48,644 --> 05:06:50,946
MEANINGFUL COMPARATORS, GIVEN

7706
05:06:50,946 --> 05:06:51,814
THIS EVOLVING LANDSCAPE SO THAT,

7707
05:06:51,814 --> 05:06:55,784
AGAIN, AT THE END OF THE STUDY

7708
05:06:55,784 --> 05:07:01,023
WE'RE STILL INFORMING AN

7709
05:07:01,023 --> 05:07:01,790
IMPORTANT DECISION.

7710
05:07:01,790 --> 05:07:04,226
IN ADDITION TO THE EVOLVING

7711
05:07:04,226 --> 05:07:06,295
STANDARD OF CARE IT'S ALSO THE

7712
05:07:06,295 --> 05:07:11,233
CASE THAT OVER TIME WE'RE JUST

7713
05:07:11,233 --> 05:07:12,635
SEEING NEW INDICATIONS FOR THESE

7714
05:07:12,635 --> 05:07:13,135
THERAPIES.

7715
05:07:13,135 --> 05:07:15,704
YOU COULD IMAGINE, YOU KNOW, A

7716
05:07:15,704 --> 05:07:16,438
PATIENT MIGHT -- A PARTICIPANT

7717
05:07:16,438 --> 05:07:19,542
OVER THE COURSE OF THE TRIAL

7718
05:07:19,542 --> 05:07:21,911
MIGHT ACTUALLY BECOME ELIGIBLE

7719
05:07:21,911 --> 05:07:24,580
FOR THE THERAPY BY VIRTUE OF A

7720
05:07:24,580 --> 05:07:26,982
NEW APPROVED INDICATION FOR THE

7721
05:07:26,982 --> 05:07:27,583
THERAPY.

7722
05:07:27,583 --> 05:07:30,286
SO IT IS A COMPLICATED

7723
05:07:30,286 --> 05:07:32,354
LANDSCAPE, BOTH IN TERMS OF THE

7724
05:07:32,354 --> 05:07:34,456
STANDARD OF CARE AND HOW THAT'S

7725
05:07:34,456 --> 05:07:36,592
EVOLVING BUT ALSO IN TERMS OF

7726
05:07:36,592 --> 05:07:38,127
THE GROWING NUMBER OF

7727
05:07:38,127 --> 05:07:43,832
INDICATIONS FOR WHICH THESE

7728
05:07:43,832 --> 05:07:45,467
THERAPIES HAVE BEEN APPROVED.

7729
05:07:45,467 --> 05:07:48,437
WE'VE TALKED A LOT ABOUT

7730
05:07:48,437 --> 05:07:49,939
ADHERENCE AND DISCONTINUATION.

7731
05:07:49,939 --> 05:07:54,143
WHAT WE HAVEN'T TOUCHED ON YET

7732
05:07:54,143 --> 05:07:55,311
IS CONTAMINATION.

7733
05:07:55,311 --> 05:07:58,447
MAYBE JUST WITH RESPECT TO

7734
05:07:58,447 --> 05:08:02,017
ADHERENCE AND DISCONTINUATION, I

7735
05:08:02,017 --> 05:08:03,953
THINK IN ANY TRIAL, PRAGMATIC

7736
05:08:03,953 --> 05:08:05,821
TRIAL EVEN, WE WANT TO BE ABLE

7737
05:08:05,821 --> 05:08:08,891
TO USE EXISTING DATA TO MONITOR

7738
05:08:08,891 --> 05:08:11,527
EARLY SIGNS OF DISCONTINUATION.

7739
05:08:11,527 --> 05:08:14,029
AND EVEN CONSIDER STRUCTURED OR

7740
05:08:14,029 --> 05:08:15,130
REALTIME CAPTURE OF

7741
05:08:15,130 --> 05:08:16,131
DISCONTINUATION REASONS.

7742
05:08:16,131 --> 05:08:19,735
I THINK SEVERAL SPEAKERS HAVE

7743
05:08:19,735 --> 05:08:21,704
NOTED THE IMPORTANCE OF REALLY

7744
05:08:21,704 --> 05:08:25,074
GATHERING ADDITIONAL INFORMATION

7745
05:08:25,074 --> 05:08:26,742
ABOUT WHAT'S DRIVING

7746
05:08:26,742 --> 05:08:27,476
DISCONTINUATION.

7747
05:08:27,476 --> 05:08:30,212
YOU KNOW, CONTAMINATION IS A

7748
05:08:30,212 --> 05:08:33,182
REAL ISSUE AS WELL BECAUSE

7749
05:08:33,182 --> 05:08:35,251
PARTICIPANTS WERE RANDOMIZED TO

7750
05:08:35,251 --> 05:08:38,454
NON-GLP-1 ARM MAY SEEK OUT THE

7751
05:08:38,454 --> 05:08:39,255
DRUG INDEPENDENTLY.

7752
05:08:39,255 --> 05:08:43,125
AND THAT THAT CAN CERTAINLY

7753
05:08:43,125 --> 05:08:44,927
HAPPEN AND WE'RE SEEING THAT.

7754
05:08:44,927 --> 05:08:47,763
YOU KNOW, SEVERAL HAVE MENTIONED

7755
05:08:47,763 --> 05:08:50,599
THE CHALLENGE OF COST AND

7756
05:08:50,599 --> 05:08:52,234
COVERAGE BECAUSE IN THE REAL

7757
05:08:52,234 --> 05:08:55,404
WORLD AS WE'VE HEARD, IT'S JUST

7758
05:08:55,404 --> 05:08:58,674
ACCESS IS HIGHLY VARIABLE.

7759
05:08:58,674 --> 05:09:00,309
SO, IN FACT ANIA SHARED WHAT IN

7760
05:09:00,309 --> 05:09:02,077
A LOOKS LIKE TO THE PATIENT WHEN

7761
05:09:02,077 --> 05:09:04,046
THEY RECEIVE THEM IN THE TRIAL

7762
05:09:04,046 --> 05:09:08,117
BUT MIGHT NOT RECEIVE THEM

7763
05:09:08,117 --> 05:09:08,550
AFTERWARDS.

7764
05:09:08,550 --> 05:09:11,320
THERE'S OPTIONS FOR TEMPORARY

7765
05:09:11,320 --> 05:09:13,055
COVERAGE FOR PARTICIPANTS, BUT

7766
05:09:13,055 --> 05:09:15,257
IT'S -- THIS IS A REAL CHALLENGE

7767
05:09:15,257 --> 05:09:17,026
I THINK THAT WE FACE AS WE THINK

7768
05:09:17,026 --> 05:09:21,630
ABOUT HOW TO DESIGN THESE

7769
05:09:21,630 --> 05:09:22,064
STUDIES.

7770
05:09:22,064 --> 05:09:24,667
AND THEN, YOU KNOW, IT'S

7771
05:09:24,667 --> 05:09:26,235
IMPORTANT TO REMEMBER THAT WE'VE

7772
05:09:26,235 --> 05:09:30,939
GOT SOME REAL -- I WOULD CALL IT

7773
05:09:30,939 --> 05:09:32,441
STAKEHOLDER MISALIGNMENT HERE.

7774
05:09:32,441 --> 05:09:34,243
MANUFACTURERS MAY BE VERY

7775
05:09:34,243 --> 05:09:36,178
RELUCTANT OR UNWILLING TO FUND

7776
05:09:36,178 --> 05:09:39,014
OR SUPPORT TRIALS THAT HAVE THE

7777
05:09:39,014 --> 05:09:41,317
POTENTIAL TO REVEAL LIMITED REAL

7778
05:09:41,317 --> 05:09:42,318
WORLD EFFECTIVENESS.

7779
05:09:42,318 --> 05:09:44,486
THINK ABOUT THE HEAD-TO-HEAD

7780
05:09:44,486 --> 05:09:49,325
TRIAL THAT WE MIGHT LONG FOR,

7781
05:09:49,325 --> 05:09:51,493
AND THERE'S A REAL RISK TO THE

7782
05:09:51,493 --> 05:09:54,997
MANUFACTURERS OF BOTH THERAPIES 

7783
05:09:54,997 --> 05:10:01,570
AND SO THINKING ABOUT HOW WE

7784
05:10:01,570 --> 05:10:02,971
ALIGN THE VALUES, PERSPECTIVES

7785
05:10:02,971 --> 05:10:06,175
AN NEEDS OF STAKEHOLDERS IS

7786
05:10:06,175 --> 05:10:06,642
IMPORTANT.

7787
05:10:06,642 --> 05:10:08,143
HEALTH SYSTEMS OFTEN DON'T HAVE

7788
05:10:08,143 --> 05:10:10,879
OR DON'T REALLY HAVE INCENTIVES

7789
05:10:10,879 --> 05:10:15,384
TO PARTICIPATE IN PRAGMATIC

7790
05:10:15,384 --> 05:10:17,986
TRIALS, AND SO, AS PEOPLE WHO DO

7791
05:10:17,986 --> 05:10:19,822
PRAGMATIC TRIALS WE TALK ABOUT

7792
05:10:19,822 --> 05:10:20,823
IMPORTANCE OF ENGAGING HEALTH

7793
05:10:20,823 --> 05:10:22,691
SYSTEM TO UNDERSTAND LIKE WHERE

7794
05:10:22,691 --> 05:10:24,960
THE VALUE IS FOR THEM IN THE

7795
05:10:24,960 --> 05:10:27,296
ANSWER AND MAKING SURE THEN THAT

7796
05:10:27,296 --> 05:10:31,867
THE TRIAL ANSWERS THAT QUESTION.

7797
05:10:31,867 --> 05:10:34,303
AND PAYERS, WE'VE TALKED ABOUT

7798
05:10:34,303 --> 05:10:35,637
THIS BEFORE TODAY, HAVE A SHORT

7799
05:10:35,637 --> 05:10:38,140
TIME HORIZON SO THEY MAY NOT

7800
05:10:38,140 --> 05:10:39,675
REALIZE THE LONG-TERM BENEFITS

7801
05:10:39,675 --> 05:10:43,379
AND WOULD ALSO BE RELUCTANT TO

7802
05:10:43,379 --> 05:10:44,380
SUPPORT THESE TRIALS.

7803
05:10:44,380 --> 05:10:46,815
IN THE END, JUST TO WRAP THIS

7804
05:10:46,815 --> 05:10:48,350
UP, YOU KNOW, THINK AS WE'VE

7805
05:10:48,350 --> 05:10:51,854
HEARD TODAY THERE ARE MANY, MANY

7806
05:10:51,854 --> 05:10:53,155
QUESTIONS RELATED TO GLP-1

7807
05:10:53,155 --> 05:10:55,224
THERAPIES FOR WHICH WE NEED

7808
05:10:55,224 --> 05:10:57,526
ANSWERS, AND WE NEED THEM IN THE

7809
05:10:57,526 --> 05:10:59,161
REAL WORLD.

7810
05:10:59,161 --> 05:11:02,765
I WOULD ARGUE THAT SOME OF THOSE

7811
05:11:02,765 --> 05:11:07,035
QUESTIONS MAY BE ALMOST

7812
05:11:07,035 --> 05:11:08,337
IMPOSSIBLE TO ANSWER WITHOUT

7813
05:11:08,337 --> 05:11:10,005
RANDOMIZATION, OTHERS MAY HAVE

7814
05:11:10,005 --> 05:11:10,539
DIFFERENT PERSPECTIVES BUT

7815
05:11:10,539 --> 05:11:13,142
ACTUALLY THE QUESTION ABOUT, YOU

7816
05:11:13,142 --> 05:11:15,577
KNOW, HOW TO REDUCE USE, HOW TO

7817
05:11:15,577 --> 05:11:19,181
TITRATE IT DOWN OVER TIME, MAYBE

7818
05:11:19,181 --> 05:11:21,150
IN COMBINATION WITH LIFESTYLE

7819
05:11:21,150 --> 05:11:23,018
INTERVENTIONS, THOSE KINDS OF

7820
05:11:23,018 --> 05:11:24,753
QUESTIONS TAPERING QUESTIONS CAN

7821
05:11:24,753 --> 05:11:29,124
BE VERY CHALLENGING TO ANSWER IN

7822
05:11:29,124 --> 05:11:30,292
EVEN AN EXQUISITELY

7823
05:11:30,292 --> 05:11:30,993
WELL-DESIGNED OBSERVATIONAL

7824
05:11:30,993 --> 05:11:31,193
STUDY.

7825
05:11:31,193 --> 05:11:33,729
AS WE THINK ABOUT THE KINDS OF

7826
05:11:33,729 --> 05:11:35,030
QUESTIONS THAT NEED ANSWERS,

7827
05:11:35,030 --> 05:11:39,101
IT'S IMPORTANT TO REMEMBER THAT

7828
05:11:39,101 --> 05:11:40,035
PRAGMATIC TRIALS ARE REALLY

7829
05:11:40,035 --> 05:11:44,139
IMPORTANT TOOL, IF YOU WILL, IN

7830
05:11:44,139 --> 05:11:45,073
OUR METHODOLOGICAL TOOLBOX.

7831
05:11:45,073 --> 05:11:48,277
AND WITH THAT I WILL STOP

7832
05:11:48,277 --> 05:11:49,445
SHARING.

7833
05:11:49,445 --> 05:11:51,313
>> THANK YOU, LESLEY.

7834
05:11:51,313 --> 05:11:53,849
THAT WAS GREAT.

7835
05:11:53,849 --> 05:12:04,293
NEXT SPEAKER IS DR. MIGUEL

7836
05:12:04,526 --> 05:12:06,094
HERNAN, HARVARD CHAN SCHOOL OF

7837
05:12:06,094 --> 05:12:06,962
PUBLIC HEALTH.

7838
05:12:06,962 --> 05:12:09,264
I CANNOT THINK OF A BETTER

7839
05:12:09,264 --> 05:12:15,404
PERSON TO SPEAK ABOUT THE TOPIC

7840
05:12:15,404 --> 05:12:19,641
OF EMULATION THAN MIGUEL, HE'S

7841
05:12:19,641 --> 05:12:22,311
THE PERSON THAT DEVELOPED,

7842
05:12:22,311 --> 05:12:24,480
REFINED, AND APPLIED A FRAMEWORK

7843
05:12:24,480 --> 05:12:26,348
AND CONVENED EVERYONE THAT THIS

7844
05:12:26,348 --> 05:12:31,587
IS REALLY SOMETHING WE SHOULD

7845
05:12:31,587 --> 05:12:34,122
CONSIDER TO IMPROVE RIGOR OF

7846
05:12:34,122 --> 05:12:37,493
REAL WORLD DATA STUDIES, TALKING

7847
05:12:37,493 --> 05:12:40,362
ABOUT USING TRIAL EMULATION

7848
05:12:40,362 --> 05:12:41,630
FRAMEWORK TO STUDY GLP-1-BASED

7849
05:12:41,630 --> 05:12:43,499
THERAPY USING REAL WORLD DATA.

7850
05:12:43,499 --> 05:12:43,732
MIGUEL?

7851
05:12:43,732 --> 05:12:45,400
>>  THANK YOU VERY MUCH.

7852
05:12:45,400 --> 05:12:47,169
ARE MY SLIDES UP?

7853
05:12:47,169 --> 05:12:50,639
CAN YOU HEAR ME?

7854
05:12:50,639 --> 05:12:52,441
>>  YES.

7855
05:12:52,441 --> 05:12:53,408
>> FANTASTIC.

7856
05:12:53,408 --> 05:12:55,477
SO, YEAH, LET'S TALK ABOUT OUR

7857
05:12:55,477 --> 05:13:00,382
REAL WORLD DATA AND LESLEY HAS

7858
05:13:00,382 --> 05:13:03,218
PRESENTED IN SUCH A WAY THIS

7859
05:13:03,218 --> 05:13:06,522
FLOWS VERY NICELY FROM HER

7860
05:13:06,522 --> 05:13:06,855
PRESENTATION.

7861
05:13:06,855 --> 05:13:12,661
SO, THIS IS MY OTHER RELEVANT

7862
05:13:12,661 --> 05:13:15,664
ENGAGEMENTS, AND I'M GOING TO

7863
05:13:15,664 --> 05:13:18,500
START BY SAYING SOMETHING THAT

7864
05:13:18,500 --> 05:13:22,571
WE KNOW HERE, WHICH IS NONE OF

7865
05:13:22,571 --> 05:13:26,508
THE TRIALS CAN ANSWER ALL

7866
05:13:26,508 --> 05:13:27,843
QUESTIONS, WE'RE TALKING ABOUT

7867
05:13:27,843 --> 05:13:29,011
OBSERVATIONAL AND REAL WORLD,

7868
05:13:29,011 --> 05:13:31,113
SOME TOO EXPENSIVE, NOT ETHICAL,

7869
05:13:31,113 --> 05:13:33,382
SOME NOT PRACTICAL, SOME WILL BE

7870
05:13:33,382 --> 05:13:35,717
DONE AT SOME POINT, BUT NOT YET.

7871
05:13:35,717 --> 05:13:39,655
AND WE NEED TO MAKE DECISIONS

7872
05:13:39,655 --> 05:13:40,389
NOW.

7873
05:13:40,389 --> 05:13:43,592
ALSO, AS LESLEY MENTIONED,

7874
05:13:43,592 --> 05:13:45,027
SOMETIMES THERE'S MISALIGNMENT

7875
05:13:45,027 --> 05:13:47,863
OF INCENTIVES AND SOME TRIALS,

7876
05:13:47,863 --> 05:13:48,530
ESPECIALLY HEAD-TO-HEAD TRIALS

7877
05:13:48,530 --> 05:13:52,568
WHICH WOULD BE VERY IMPORTANT

7878
05:13:52,568 --> 05:13:56,305
FOR GLP-1-BASED THERAPIES ARE

7879
05:13:56,305 --> 05:13:58,707
NOT DONE BECAUSE MANUFACTURERS

7880
05:13:58,707 --> 05:14:00,876
DON'T HAVE INCENTIVE TO PAY FOR

7881
05:14:00,876 --> 05:14:03,512
THEM AND THE PAYERS AND HEALTH

7882
05:14:03,512 --> 05:14:09,551
SYSTEMS MAY NOT BE SET UP

7883
05:14:09,551 --> 05:14:11,420
APPROPRIATELY FOR RESEARCH.

7884
05:14:11,420 --> 05:14:12,955
THE CASE WITH THAT, THE NUMBER

7885
05:14:12,955 --> 05:14:14,723
OF QUESTIONS THAT WE HAVE IS

7886
05:14:14,723 --> 05:14:17,759
ALWAYS GOING TO BE GREATER THAN

7887
05:14:17,759 --> 05:14:20,095
THE NUMBER OF TRIALS THAT AS A

7888
05:14:20,095 --> 05:14:21,563
SOCIETY WE CAN CONDUCT.

7889
05:14:21,563 --> 05:14:24,132
SO YOU THINK ABOUT ALL THE

7890
05:14:24,132 --> 05:14:26,535
QUESTIONS WE HAVE FOR EVERY

7891
05:14:26,535 --> 05:14:28,203
POSSIBLE COMBINATION OF

7892
05:14:28,203 --> 05:14:29,171
TREATMENTS, FOR DIFFERENT

7893
05:14:29,171 --> 05:14:33,108
OUTCOMES, OVER DIFFERENT TIME

7894
05:14:33,108 --> 05:14:36,712
PERIODS, FOR DIFFERENT SUBGROUPS

7895
05:14:36,712 --> 05:14:37,579
BASED ON CLINICAL

7896
05:14:37,579 --> 05:14:38,180
CHARACTERISTICS SO WE'RE NOT

7897
05:14:38,180 --> 05:14:40,983
GOING TO BE ABLE TO CONDUCT

7898
05:14:40,983 --> 05:14:44,219
TRIALS TO ANSWER ALL QUESTIONS

7899
05:14:44,219 --> 05:14:46,355
THAT WE MAY HAVE IN A PRECISE

7900
05:14:46,355 --> 05:14:47,255
WAY.

7901
05:14:47,255 --> 05:14:49,925
THAT'S REALLY WHY WE NEED TO

7902
05:14:49,925 --> 05:14:55,564
TALK ABOUT -- THIS IS NOT

7903
05:14:55,564 --> 05:14:57,532
SOMETHING THAT IS AN OPTION THAT

7904
05:14:57,532 --> 05:14:58,734
WE HAVE.

7905
05:14:58,734 --> 05:15:01,370
IT'S WHAT WE WILL HAVE TO BE

7906
05:15:01,370 --> 05:15:02,904
USING EVEN ONCE YOU USE HUMAN

7907
05:15:02,904 --> 05:15:07,376
DATA TO INFORM SOME OF THE

7908
05:15:07,376 --> 05:15:13,215
DECISIONS THAT WE MAKE.

7909
05:15:13,215 --> 05:15:14,316
PHARMACOTHERAPY, GLP-1-BASED

7910
05:15:14,316 --> 05:15:16,485
THERAPIES IN PARTICULAR.

7911
05:15:16,485 --> 05:15:18,020
THE QUESTION, THE QUESTION IS

7912
05:15:18,020 --> 05:15:19,655
NOT WHETHER TO USE OBSERVATIONAL

7913
05:15:19,655 --> 05:15:25,327
DATA BUT HOW TO USE IT

7914
05:15:25,327 --> 05:15:25,594
CORRECTLY.

7915
05:15:25,594 --> 05:15:28,630
AND WE'VE HEARD ABOUT DIFFERENT

7916
05:15:28,630 --> 05:15:29,731
TYPES OF OBSERVATIONAL DATA,

7917
05:15:29,731 --> 05:15:33,035
SOME OF THESE DATASETS ARE

7918
05:15:33,035 --> 05:15:36,605
ASSEMBLED SPECIFICALLY FOR

7919
05:15:36,605 --> 05:15:40,542
RESEARCH PURPOSES, COHORTS, SOME

7920
05:15:40,542 --> 05:15:42,978
CASES CONTROL STUDIES, SO

7921
05:15:42,978 --> 05:15:45,814
BECAUSE THESE DATASETS HAVE BEEN

7922
05:15:45,814 --> 05:15:47,783
DESIGNED FOR RESEARCH, MEANING

7923
05:15:47,783 --> 05:15:48,450
THAT INVESTIGATORS HAVE CONTROL

7924
05:15:48,450 --> 05:15:53,055
OVER THE DATA THAT ARE BEING

7925
05:15:53,055 --> 05:15:54,589
GENERATED.

7926
05:15:54,589 --> 05:15:56,892
THEY TEND TO HAVE SOME

7927
05:15:56,892 --> 05:15:59,828
ADVANTAGES THAT OTHER TYPES OF

7928
05:15:59,828 --> 05:16:02,464
DATA NOT GENERATED FOR RESEARCH,

7929
05:16:02,464 --> 05:16:04,132
AND OF COURSE THOSE STUDIES

7930
05:16:04,132 --> 05:16:10,005
WE'VE BEEN TALKING ABOUT HERE A

7931
05:16:10,005 --> 05:16:13,175
LOT DURING TALKS, DATA THAT ARE

7932
05:16:13,175 --> 05:16:15,043
GENERATED FOR CLINICAL PURPOSES

7933
05:16:15,043 --> 05:16:17,345
LIKE ELECTRONIC HEALTH RECORDS

7934
05:16:17,345 --> 05:16:18,780
OR FOR INSURANCE PURPOSES LIKE

7935
05:16:18,780 --> 05:16:20,382
CLAIMS, ET CETERA.

7936
05:16:20,382 --> 05:16:21,917
ALL THESE DATABASES THAT WOULD

7937
05:16:21,917 --> 05:16:27,522
HAPPEN TO FIND IN THE REAL WORLD

7938
05:16:27,522 --> 05:16:30,325
BUT WE AS INVESTIGATORS HAVE NO

7939
05:16:30,325 --> 05:16:33,195
POSSIBILITY OF DESIGNING IN A

7940
05:16:33,195 --> 05:16:35,063
WAY FOR OUR RESEARCH, THIS IS

7941
05:16:35,063 --> 05:16:39,334
WHAT IS KNOWN AS REAL WORLD DATA

7942
05:16:39,334 --> 05:16:41,203
FROM OBSERVATIONAL POINT OF

7943
05:16:41,203 --> 05:16:41,403
VIEW.

7944
05:16:41,403 --> 05:16:43,238
WE SOMETIMES CALL IT SOUND DATA.

7945
05:16:43,238 --> 05:16:44,806
DATA WE FIND IN THE REAL WORLD

7946
05:16:44,806 --> 05:16:49,311
AND WE TRY TO REPURPOSE FOR

7947
05:16:49,311 --> 05:16:49,578
RESEARCH.

7948
05:16:49,578 --> 05:16:51,379
NOW, WE HAVE A LOT OF THIS TYPE

7949
05:16:51,379 --> 05:16:52,914
OF REAL WORLD DATA.

7950
05:16:52,914 --> 05:16:54,449
AND WE HAVE THESE DATA FOR A

7951
05:16:54,449 --> 05:16:56,184
VERY LONG TIME.

7952
05:16:56,184 --> 05:16:59,921
THIS IS NOT NEW.

7953
05:16:59,921 --> 05:17:00,989
PHARMACO EPIDEMIOLOGISTS WERE

7954
05:17:00,989 --> 05:17:03,391
USING DATABASES OF ELECTRONIC

7955
05:17:03,391 --> 05:17:05,393
HEALTH RECORDS IN THE 1970s,

7956
05:17:05,393 --> 05:17:06,261
AND '80s.

7957
05:17:06,261 --> 05:17:08,463
AND WHAT IS DIFFERENT IS THAT

7958
05:17:08,463 --> 05:17:11,600
MORE OF THEM NOW, WE HAVE MORE

7959
05:17:11,600 --> 05:17:12,601
DATA NOW.

7960
05:17:12,601 --> 05:17:14,803
IT'S VERY COMMON NOW TO HAVE

7961
05:17:14,803 --> 05:17:16,304
DATABASES WITH MILLIONS OF

7962
05:17:16,304 --> 05:17:18,073
PEOPLE, THAT WASN'T THAT COMMON

7963
05:17:18,073 --> 05:17:21,910
IN THE '70s OR '80s, AND

7964
05:17:21,910 --> 05:17:23,211
THERE IS DETAILED INFORMATION ON

7965
05:17:23,211 --> 05:17:24,546
A LOT OF THINGS THAT WE'RE GOING

7966
05:17:24,546 --> 05:17:29,451
TO BE USING FOR OUR RESEARCH

7967
05:17:29,451 --> 05:17:33,054
LIKE THERAPIES, ET CETERA. 

7968
05:17:33,054 --> 05:17:37,025
THIS IS VERY PROMISING, AND YET

7969
05:17:37,025 --> 05:17:38,527
IF YOU READ THE MEDICAL

7970
05:17:38,527 --> 05:17:41,263
LITERATURE FOR THE LAST FEW

7971
05:17:41,263 --> 05:17:45,100
DECADES, IT'S FULL OF

7972
05:17:45,100 --> 05:17:48,069
SPECTACULAR FAILURES OF CAUSAL

7973
05:17:48,069 --> 05:17:48,837
INFERENCE FROM OBSERVATIONAL

7974
05:17:48,837 --> 05:17:49,271
DATA.

7975
05:17:49,271 --> 05:17:51,239
I'M GOING TO BRIEFLY MENTION

7976
05:17:51,239 --> 05:17:54,109
TWO, BUT I COULD TALK ABOUT MANY

7977
05:17:54,109 --> 05:17:56,178
MORE AND I'M SURE MOST OF YOU

7978
05:17:56,178 --> 05:17:59,080
KNOW OF MANY MORE TOO.

7979
05:17:59,080 --> 05:18:01,082
SO, I WANT YOU TO TALK ABOUT ONE

7980
05:18:01,082 --> 05:18:04,452
BASED ON RESEARCH DATA AND ONE

7981
05:18:04,452 --> 05:18:08,523
ON FOUND DATA, REAL WORLD DATA. 

7982
05:18:08,523 --> 05:18:12,527
THE STUDY WAS PUBLISHED IN 1996,

7983
05:18:12,527 --> 05:18:14,029
AND CLAIM HORMONE THERAPY

7984
05:18:14,029 --> 05:18:19,167
PREVENTS CORONARY HEART DISEASE

7985
05:18:19,167 --> 05:18:22,170
IN POSTMENOPAUSAL WOMEN.

7986
05:18:22,170 --> 05:18:23,872
RESULTS AND CONCLUSIONS OF THIS

7987
05:18:23,872 --> 05:18:26,508
STUDY WAS THAT THERE WAS A

7988
05:18:26,508 --> 05:18:28,443
MARKED DECREASE IN RISK OF MAJOR

7989
05:18:28,443 --> 05:18:30,645
CORONARY HEART DISEASE AMONG

7990
05:18:30,645 --> 05:18:35,016
WOMEN WHO TOOK IT AS OPPOSED.

7991
05:18:35,016 --> 05:18:36,117
NOW, SEVEN YEARS LATER,

7992
05:18:36,117 --> 05:18:39,621
RANDOMIZED TRIAL WAS PUBLISHED,

7993
05:18:39,621 --> 05:18:43,458
IN THE SAME JOURNAL, THAT IT WAS

7994
05:18:43,458 --> 05:18:45,427
WRONG, HORMONE THERAPY DOES NOT

7995
05:18:45,427 --> 05:18:46,628
PREVENT CORONARY HEART DISEASE

7996
05:18:46,628 --> 05:18:47,596
IN POSTMENOPAUSAL WOMEN.

7997
05:18:47,596 --> 05:18:54,736
AND THESE ARE  CONCLUSIONS, DO

7998
05:18:54,736 --> 05:18:57,239
NOT CONFER CARDIAC PROTECTION.

7999
05:18:57,239 --> 05:18:59,574
AND MAY INCREASE RISK OF

8000
05:18:59,574 --> 05:19:01,276
CORONARY HEART DISEASE.

8001
05:19:01,276 --> 05:19:07,415
THIS IS ONE EXAMPLE.

8002
05:19:07,415 --> 05:19:11,386
ANOTHER EXAMPLE WAS THE EXAMPLE

8003
05:19:11,386 --> 05:19:14,222
OF THERAPY WE'VE STUDIED AND

8004
05:19:14,222 --> 05:19:15,991
RISK OF COLORECTAL CANCERS, A

8005
05:19:15,991 --> 05:19:19,728
STUDY PUBLISHED AGAIN IN THE

8006
05:19:19,728 --> 05:19:21,997
SAME JOURNAL IN 2005, AND

8007
05:19:21,997 --> 05:19:27,602
CONCLUSION WAS USE OF STUDIES

8008
05:19:27,602 --> 05:19:29,337
WAS ASSOCIATED WITH 50%

8009
05:19:29,337 --> 05:19:33,074
REDUCTION IN RISK OF COLORECTAL

8010
05:19:33,074 --> 05:19:34,376
CANCER.

8011
05:19:34,376 --> 05:19:38,113
A FEW MONTHS LATER, AGAIN, THERE

8012
05:19:38,113 --> 05:19:39,514
WAS EVIDENCE FROM RANDOMIZED

8013
05:19:39,514 --> 05:19:43,018
TRIALS SHOWING THAT WAS WRONG.

8014
05:19:43,018 --> 05:19:48,690
IN FACT, THERE WAS NO EFFECT ON

8015
05:19:48,690 --> 05:19:52,527
CANCER OR CANCER DEATH

8016
05:19:52,527 --> 05:19:53,061
ESTABLISHED.

8017
05:19:53,061 --> 05:19:57,132
THIS IS TWO EXAMPLES FROM A VERY

8018
05:19:57,132 --> 05:19:59,200
LONG LIST OF WHY HISTORY SHOWS

8019
05:19:59,200 --> 05:20:01,736
US WE CANNOT TRUST CAUSAL

8020
05:20:01,736 --> 05:20:03,905
INFERENCE BASED ON OBSERVATIONAL

8021
05:20:03,905 --> 05:20:05,573
DATA.

8022
05:20:05,573 --> 05:20:09,277
AND IT IS ALSO JUST A SIDE

8023
05:20:09,277 --> 05:20:12,914
COMMENT, NONE OF THESE

8024
05:20:12,914 --> 05:20:14,549
CATASTROPHIC FAILURES HAVE BEEN

8025
05:20:14,549 --> 05:20:15,517
RETRACTED IN JOURNALS, WE KNOW

8026
05:20:15,517 --> 05:20:18,820
THEY ARE WRONG AND KNOW THEY ARE

8027
05:20:18,820 --> 05:20:19,421
WRONG.

8028
05:20:19,421 --> 05:20:22,090
THE QUESTION IS PRECISELY THAT,

8029
05:20:22,090 --> 05:20:22,757
WHY?

8030
05:20:22,757 --> 05:20:27,028
WHY SO MANY OBSERVATIONAL

8031
05:20:27,028 --> 05:20:28,363
ANALYSES ARE BIASED?

8032
05:20:28,363 --> 05:20:30,432
THERE ARE TWO POSSIBLE

8033
05:20:30,432 --> 05:20:33,802
EXPLANATIONS TO THAT QUESTION.

8034
05:20:33,802 --> 05:20:36,905
ONE POSSIBLE EXPLANATION IS THAT

8035
05:20:36,905 --> 05:20:38,440
OBSERVATIONAL DATASETS ARE NOT

8036
05:20:38,440 --> 05:20:42,510
BAD, AND THE OTHER POSSIBLE

8037
05:20:42,510 --> 05:20:43,478
EXPLANATION IS THAT

8038
05:20:43,478 --> 05:20:44,913
OBSERVATIONAL DATASETS ARE NOT

8039
05:20:44,913 --> 05:20:46,348
USED WELL.

8040
05:20:46,348 --> 05:20:50,819
THOSE ARE VERY DIFFERENT

8041
05:20:50,819 --> 05:20:51,920
EXPLANATIONS WITH DIFFERENT

8042
05:20:51,920 --> 05:20:54,656
IMPLICATIONS FOR USES THAT WE'RE

8043
05:20:54,656 --> 05:20:57,192
DISCUSSING HERE TODAY BECAUSE

8044
05:20:57,192 --> 05:21:00,261
IT'S POSSIBLE THAT OBSERVATIONAL

8045
05:21:00,261 --> 05:21:01,363
DATASETS DON'T HAVE ENOUGH DATA

8046
05:21:01,363 --> 05:21:05,367
TO ANSWER THE QUESTIONS THAT WE

8047
05:21:05,367 --> 05:21:07,135
WANT TO ANSWER.

8048
05:21:07,135 --> 05:21:09,838
MAYBE TOO MUCH CONFOUNDING, NOT

8049
05:21:09,838 --> 05:21:12,607
ENOUGH INFORMATION IN THE

8050
05:21:12,607 --> 05:21:19,848
DATASET TO ADJUST FOR

8051
05:21:19,848 --> 05:21:21,016
CONFOUNDERS OR MEASUREMENT

8052
05:21:21,016 --> 05:21:22,851
ERROR, BIASES WE'LL HAVE IN

8053
05:21:22,851 --> 05:21:25,353
CAUSAL INFERENCE THAT WOULD BE

8054
05:21:25,353 --> 05:21:29,791
DUE TO LIMITATIONS OF THE DATA,

8055
05:21:29,791 --> 05:21:31,860
COMMON DATA BIASES.

8056
05:21:31,860 --> 05:21:33,628
THE OTHER POSSIBILITY IS THAT

8057
05:21:33,628 --> 05:21:35,063
THESE OBSERVATIONAL DATASETS ARE

8058
05:21:35,063 --> 05:21:36,998
NOT BEING USED WELL.

8059
05:21:36,998 --> 05:21:39,467
NOT THAT THE DATA ARE

8060
05:21:39,467 --> 05:21:40,635
INEFFICIENT, THAT WE'RE NOT

8061
05:21:40,635 --> 05:21:42,170
DOING WITH THE DATA WHAT WE'RE

8062
05:21:42,170 --> 05:21:44,773
SUPPOSED TO DO WITH THE DATA.

8063
05:21:44,773 --> 05:21:47,409
AND WE DESIGN OUR OBSERVATIONAL

8064
05:21:47,409 --> 05:21:50,912
ANALYSIS IN SUCH A WAY THAT IT

8065
05:21:50,912 --> 05:21:54,182
CREATES BIAS, THAT IS CALLED

8066
05:21:54,182 --> 05:21:55,850
DESIGN BIAS.

8067
05:21:55,850 --> 05:21:56,051
OKAY.

8068
05:21:56,051 --> 05:21:57,252
LET'S TALK ABOUT THE DESIGN

8069
05:21:57,252 --> 05:22:00,088
BIASES FIRST.

8070
05:22:00,088 --> 05:22:02,524
HOW DO WE MAKE SURE THAT THESE

8071
05:22:02,524 --> 05:22:04,492
BIASES DON'T HAPPEN?

8072
05:22:04,492 --> 05:22:06,327
WELL, WE CAN THINK ABOUT

8073
05:22:06,327 --> 05:22:07,228
RANDOMIZED TRIALS.

8074
05:22:07,228 --> 05:22:09,931
WE KNOW HOW TO DESIGN AND

8075
05:22:09,931 --> 05:22:11,566
ANALYZE RANDOMIZED TRIALS AND WE

8076
05:22:11,566 --> 05:22:14,636
HAVE HEARD A LITTLE BIT ABOUT

8077
05:22:14,636 --> 05:22:15,637
THAT HERE ALREADY.

8078
05:22:15,637 --> 05:22:19,707
THERE ARE SOME THINGS THAT WE

8079
05:22:19,707 --> 05:22:22,343
KNOW, SOME BASIC PRINCIPLES FROM

8080
05:22:22,343 --> 05:22:24,646
TRIALS THAT WE KNOW LIKE, FOR

8081
05:22:24,646 --> 05:22:27,916
EXAMPLE, WE DON'T START THE

8082
05:22:27,916 --> 05:22:28,550
FOLLOW-UP OF INDIVIDUALS IN THE

8083
05:22:28,550 --> 05:22:30,118
TRIAL UNTIL THEY HAVE BEEN

8084
05:22:30,118 --> 05:22:31,753
ASSIGNED TO A TREATMENT THERAPY.

8085
05:22:31,753 --> 05:22:33,188
IN FACT, WE START THE FOLLOW-UP

8086
05:22:33,188 --> 05:22:35,490
AT THE TIME THEY ARE ASSIGNED TO

8087
05:22:35,490 --> 05:22:36,825
A TREATMENT THERAPY.

8088
05:22:36,825 --> 05:22:39,227
SEEMS SO OBVIOUS WE NEVER TALK

8089
05:22:39,227 --> 05:22:40,562
ABOUT THAT WHEN WE'RE CONDUCTING

8090
05:22:40,562 --> 05:22:41,763
A TRIAL.

8091
05:22:41,763 --> 05:22:44,699
WE NEVER SAY, OH, MAKE SURE THAT

8092
05:22:44,699 --> 05:22:47,335
YOU START THE FOLLOW-UP AT THE

8093
05:22:47,335 --> 05:22:48,236
TIME OF RANDOMIZATION.

8094
05:22:48,236 --> 05:22:51,239
THAT IS WHAT WE DO.

8095
05:22:51,239 --> 05:23:00,348
TURNS OUT MANY OBSERVATIONAL

8096
05:23:00,348 --> 05:23:01,749
ANALYSIS DON'T DO THAT.

8097
05:23:01,749 --> 05:23:04,052
PROBLEMS OF PREVIOUS EXAMPLES OF

8098
05:23:04,052 --> 05:23:08,323
HORMONE THERAPY, THE STUDY I

8099
05:23:08,323 --> 05:23:10,692
GAVE YOU, BECAUSE OF FAILURE TO

8100
05:23:10,692 --> 05:23:12,827
FOLLOW BASIC PRINCIPLES OF THE

8101
05:23:12,827 --> 05:23:15,997
STUDY DESIGN THAT WE FOLLOW BY

8102
05:23:15,997 --> 05:23:18,166
DEFAULT IN ALL TRIALS.

8103
05:23:18,166 --> 05:23:23,738
SO, THAT'S REALLY WHAT WE CAN --

8104
05:23:23,738 --> 05:23:26,374
HOW WE CAN THINK ABOUT CAUSAL

8105
05:23:26,374 --> 05:23:27,342
INFERENCE FROM OBSERVATIONAL

8106
05:23:27,342 --> 05:23:27,842
DATA.

8107
05:23:27,842 --> 05:23:30,411
WE WANT TO ESTIMATE CAUSAL

8108
05:23:30,411 --> 05:23:31,179
EFFECT USING OBSERVATIONAL DATA

8109
05:23:31,179 --> 05:23:33,681
THEN WE CAN THINK OF WHAT THE

8110
05:23:33,681 --> 05:23:34,682
HYPOTHETICAL RANDOMIZED TRIAL IS

8111
05:23:34,682 --> 05:23:38,720
THAT WE WOULD LIKE TO CONDUCT.

8112
05:23:38,720 --> 05:23:43,091
AND THEN WE STRUCTURE AND

8113
05:23:43,091 --> 05:23:44,092
ANALYZE OBSERVATIONAL DATA AS IF

8114
05:23:44,092 --> 05:23:48,296
IT WAS COMING FROM THAT TRIAL

8115
05:23:48,296 --> 05:23:50,031
BECAUSE THAT HYPOTHETICAL TRIAL

8116
05:23:50,031 --> 05:23:56,271
IS THE TARGET OF CAUSAL

8117
05:23:56,271 --> 05:23:57,705
INFERENCE, WHAT WE WOULD LIKE TO

8118
05:23:57,705 --> 05:23:59,641
DO RATHER THAN USING REAL WORLD

8119
05:23:59,641 --> 05:23:59,874
DATA.

8120
05:23:59,874 --> 05:24:02,377
TARGET TRIAL IS REALLY ONE WAY

8121
05:24:02,377 --> 05:24:03,912
OF THINKING ABOUT WHAT WE'RE

8122
05:24:03,912 --> 05:24:05,547
DOING WITH OBSERVATIONAL DATA.

8123
05:24:05,547 --> 05:24:07,215
WE SAY, OKAY, THIS IS THE TRIAL

8124
05:24:07,215 --> 05:24:08,950
THAT WE WOULD LIKE TO CONDUCT,

8125
05:24:08,950 --> 05:24:11,352
THIS IS HOW I'M GOING TO

8126
05:24:11,352 --> 05:24:13,655
ORGANIZE MY DATA TO TRY TO

8127
05:24:13,655 --> 05:24:14,289
EMULATE THAT TRIAL.

8128
05:24:14,289 --> 05:24:16,691
BY DOING THAT I'M GOING TO

8129
05:24:16,691 --> 05:24:19,794
FOLLOW THE BASIC PRINCIPLES OF

8130
05:24:19,794 --> 05:24:24,065
STUDY DESIGN AND ANALYSIS THAT

8131
05:24:24,065 --> 05:24:26,367
WE KNOW HOW TO USE FOR TRIALS.

8132
05:24:26,367 --> 05:24:28,236
THIS ACTUALLY MEANS THAT EVERY

8133
05:24:28,236 --> 05:24:30,405
TIME WE'RE USING OBSERVATIONAL

8134
05:24:30,405 --> 05:24:32,373
DATA FOR CAUSAL INFERENCES WE'RE

8135
05:24:32,373 --> 05:24:34,142
ATTEMPTING TO EMULATE TARGET

8136
05:24:34,142 --> 05:24:34,676
TRIAL.

8137
05:24:34,676 --> 05:24:36,110
SOMETIMES THAT IS NOT EXPLICIT,

8138
05:24:36,110 --> 05:24:39,380
BUT THE FACT THAT SOME PEOPLE

8139
05:24:39,380 --> 05:24:40,048
DON'T MAKE IT EXPLICIT DOESN'T

8140
05:24:40,048 --> 05:24:42,450
MEAN THEY ARE NOT TRYING TO

8141
05:24:42,450 --> 05:24:43,117
EMULATE TARGET TRIAL.

8142
05:24:43,117 --> 05:24:46,287
THEY SHALL JUST -- THEY ARE JUST

8143
05:24:46,287 --> 05:24:47,288
NOT TELLING US.

8144
05:24:47,288 --> 05:24:49,490
IT'S BETTER TO MAKE IT EXPLICIT,

8145
05:24:49,490 --> 05:24:56,397
WE CAN HAVE A MORE EFFICIENT

8146
05:24:56,397 --> 05:25:00,668
CONVERSATION ABOUT PROS AND CONS

8147
05:25:00,668 --> 05:25:02,971
OF THAT PARTICULAR ANALYSIS.

8148
05:25:02,971 --> 05:25:05,039
IT GOES BOTH WAYS BECAUSE IF

8149
05:25:05,039 --> 05:25:05,940
SOMEONE IS ANALYZING

8150
05:25:05,940 --> 05:25:07,108
OBSERVATIONAL DATA AND WE ASK,

8151
05:25:07,108 --> 05:25:11,946
HEY, CAN YOU TELL US WHAT YOUR

8152
05:25:11,946 --> 05:25:14,716
TARGET TRIAL IS AND THEY CAN NOT

8153
05:25:14,716 --> 05:25:18,519
SPECIFY, PROBABLY THAT'S

8154
05:25:18,519 --> 05:25:20,388
OBSERVATIONAL DATA, IS NOT VERY

8155
05:25:20,388 --> 05:25:21,823
GOOD, DOESN'T KNOW THE ACTUAL

8156
05:25:21,823 --> 05:25:25,760
QUESTION THAT IS TRYING TO

8157
05:25:25,760 --> 05:25:25,994
ANSWER.

8158
05:25:25,994 --> 05:25:29,497
THIS CONCEPT OF TARGET TRIAL IS

8159
05:25:29,497 --> 05:25:33,334
IT'S A VERY OLD, NOT THE LABEL,

8160
05:25:33,334 --> 05:25:35,503
THE LABEL TARGET TRIAL IS

8161
05:25:35,503 --> 05:25:40,341
SOMETHING THAT WE CAME UP WITH,

8162
05:25:40,341 --> 05:25:41,776
BUT THE CONCEPT ITSELF HAS BEEN

8163
05:25:41,776 --> 05:25:47,348
USED AT LEAST FROM THE 1950s,

8164
05:25:47,348 --> 05:25:51,619
DORN, FROM NIH, WAS WRITING

8165
05:25:51,619 --> 05:26:00,628
ABOUT THIS IN 1953, WOLD WAS AN

8166
05:26:00,628 --> 05:26:05,867
ECONOMICICIAN IN SWEDEN, AND

8167
05:26:05,867 --> 05:26:08,269
COCHRANE AND GRADUATE STUDENTS,

8168
05:26:08,269 --> 05:26:13,708
RUBIN  AND OTHERS IN THE '70s

8169
05:26:13,708 --> 05:26:19,314
AND '80s,  AS IF YOU WERE

8170
05:26:19,314 --> 05:26:21,282
COMING FROM A TRIAL.

8171
05:26:21,282 --> 05:26:24,686
WE HAD TO WAIT UNTIL 1996 THAT

8172
05:26:24,686 --> 05:26:29,490
JAMIE ROBBINS HAD A GENERAL

8173
05:26:29,490 --> 05:26:32,360
THEORY THAT HAD THE TARGET TRIAL

8174
05:26:32,360 --> 05:26:33,895
AT THE CENTER AND THAT WAS

8175
05:26:33,895 --> 05:26:37,165
GENERAL BECAUSE COULD BE USED

8176
05:26:37,165 --> 05:26:39,801
FOR TIMELINE TREATMENTS AS

8177
05:26:39,801 --> 05:26:42,337
OPPOSED TO TREATED, NOT TREATED,

8178
05:26:42,337 --> 05:26:45,340
BECAUSE WHEN WE SAY WE WANT TO

8179
05:26:45,340 --> 05:26:47,375
ESTIMATE THE EFFECT OF A

8180
05:26:47,375 --> 05:26:53,548
GLP-1-BASED THERAPY WE DON'T

8181
05:26:53,548 --> 05:26:55,550
MEAN TAKING ONE PILL, WE TALK

8182
05:26:55,550 --> 05:26:58,820
ABOUT THE EFFECT OF TAKING THE

8183
05:26:58,820 --> 05:27:01,122
PILL OVER TIME AND AS WE'VE

8184
05:27:01,122 --> 05:27:03,958
HEARD MAYBE WITH DIFFERENT DOSES

8185
05:27:03,958 --> 05:27:06,494
OVER TIME DEPENDING ON THE

8186
05:27:06,494 --> 05:27:06,894
CLINICAL RESPONSE.

8187
05:27:06,894 --> 05:27:11,132
SO GENERAL THEORY OF CAUSAL

8188
05:27:11,132 --> 05:27:17,138
INFERENCE FOR TIME IS WHAT

8189
05:27:17,138 --> 05:27:20,274
ROBINS DEVELOPED IN 1986.

8190
05:27:20,274 --> 05:27:22,710
SO, THIS CONCEPT OF TARGET TRIAL

8191
05:27:22,710 --> 05:27:27,181
LEADS TO A WAY OF THINKING ABOUT

8192
05:27:27,181 --> 05:27:28,416
CAUSAL INFERENCES FROM

8193
05:27:28,416 --> 05:27:29,517
OPERATIONAL DATA INTO STEPS.

8194
05:27:29,517 --> 05:27:32,120
FIRST ONE IS WE HAVE TO ASK THE

8195
05:27:32,120 --> 05:27:32,987
CAUSAL QUESTION.

8196
05:27:32,987 --> 05:27:35,156
SECOND IS THAT WE HAVE TO ANSWER

8197
05:27:35,156 --> 05:27:36,157
THE CAUSAL QUESTION.

8198
05:27:36,157 --> 05:27:40,995
AND HOW DO WE ASK A CAUSAL

8199
05:27:40,995 --> 05:27:42,096
QUESTION?

8200
05:27:42,096 --> 05:27:44,065
WELL, ONE NATURAL WAY IS TO

8201
05:27:44,065 --> 05:27:46,000
DESCRIBE THE PROTOCOL OF TARGET

8202
05:27:46,000 --> 05:27:46,234
TRIAL.

8203
05:27:46,234 --> 05:27:48,903
WE CAN SPECIFY THE PROTOCOL OF

8204
05:27:48,903 --> 05:27:52,306
TARGET TRIAL, THEN WE CAN --

8205
05:27:52,306 --> 05:27:55,343
THAT IS ONE NATURAL WAY OF

8206
05:27:55,343 --> 05:27:56,110
ARTICULATING CAUSAL QUESTION

8207
05:27:56,110 --> 05:27:58,513
THAT WE'RE ASKING.

8208
05:27:58,513 --> 05:28:00,281
AFTER THAT WE EITHER CONDUCT

8209
05:28:00,281 --> 05:28:03,017
TARGET TRIAL, IF WE CAN, OR WE

8210
05:28:03,017 --> 05:28:05,253
USE OBSERVATIONAL DATA TO

8211
05:28:05,253 --> 05:28:06,821
EXPLICITLY EMULATE EACH OF THE

8212
05:28:06,821 --> 05:28:08,122
COMPONENTS OF THE PROTOCOL OF

8213
05:28:08,122 --> 05:28:10,091
THE TARGET TRIAL AND EXPLICITLY

8214
05:28:10,091 --> 05:28:12,627
IS REALLY THE KEY WORD.

8215
05:28:12,627 --> 05:28:14,929
SO, WHAT I'M SAYING IS THE FIRST

8216
05:28:14,929 --> 05:28:17,432
THING WE DO WHEN WE'RE USING

8217
05:28:17,432 --> 05:28:18,633
REAL WORLD DATA, USING

8218
05:28:18,633 --> 05:28:20,835
OBSERVATIONAL DATA, TO DESIGN A

8219
05:28:20,835 --> 05:28:21,636
RANDOMIZED TRIAL.

8220
05:28:21,636 --> 05:28:24,739
AND THEN ONCE WE KNOW WHAT IS

8221
05:28:24,739 --> 05:28:27,942
THE TARGET TRIAL WE'RE TRYING TO

8222
05:28:27,942 --> 05:28:31,646
EMULATE THEN WE CAN MOVE TO WORK

8223
05:28:31,646 --> 05:28:34,715
WITH OBSERVATIONAL DATA. 

8224
05:28:34,715 --> 05:28:37,552
WHEN I SAY WE SPECIFY PROTOCOL

8225
05:28:37,552 --> 05:28:39,720
OF TARGET TRIAL WE SPECIFY EACH

8226
05:28:39,720 --> 05:28:42,056
OF THE BASIC COMPONENTS OF THE

8227
05:28:42,056 --> 05:28:44,559
PROTOCOL OF ANY RANDOMIZED TRIAL

8228
05:28:44,559 --> 05:28:54,535
WE HAVE TO DESCRIBE ELIGIBILITY

8229
05:28:54,535 --> 05:28:57,505
CRITERIA, TREATMENT STRATEGIES,

8230
05:28:57,505 --> 05:28:58,105
ASSIGNMENT, OUTCOMES, CAUSAL

8231
05:28:58,105 --> 05:28:58,906
CONTRASTS, ET CETERA.

8232
05:28:58,906 --> 05:29:02,443
AND THEN ONCE WE HAVE OUR

8233
05:29:02,443 --> 05:29:04,312
PROTOCOLS, THEN WE GO TO THE

8234
05:29:04,312 --> 05:29:06,047
OBSERVATIONAL DATA AND DESCRIBE

8235
05:29:06,047 --> 05:29:11,486
HOW WE MAP EACH OF THESE

8236
05:29:11,486 --> 05:29:14,021
COMPONENTS INTO THE

8237
05:29:14,021 --> 05:29:14,455
OBSERVATIONAL DATA.

8238
05:29:14,455 --> 05:29:17,758
NOW, BY DOING THIS, WE WILL

8239
05:29:17,758 --> 05:29:18,960
ELIMINATE THE DESIGN BIASES.

8240
05:29:18,960 --> 05:29:24,999
BY DOING THIS WE MAKE SURE THERE

8241
05:29:24,999 --> 05:29:28,035
ARE NOT BIASES DUE TO SELECTION

8242
05:29:28,035 --> 05:29:30,605
OF PREVALENT USERS OR IMMORTAL

8243
05:29:30,605 --> 05:29:33,307
TIME, THEY DISAPPEAR IF WE DO

8244
05:29:33,307 --> 05:29:35,276
THIS PROCESS WELL.

8245
05:29:35,276 --> 05:29:38,112
WE'RE LEFT WITH DATA BIASES.

8246
05:29:38,112 --> 05:29:43,150
IF THERE ARE NOT ENOUGH

8247
05:29:43,150 --> 05:29:44,619
CONFOUNDERS, THOSE THINGS CANNOT

8248
05:29:44,619 --> 05:29:46,721
BE USING THE TARGET TRIAL

8249
05:29:46,721 --> 05:29:47,421
FRAMEWORK.

8250
05:29:47,421 --> 05:29:49,957
WHAT IS THE IMPORTANCE OF

8251
05:29:49,957 --> 05:29:51,726
ELIMINATING THE DESIGN BIASES?

8252
05:29:51,726 --> 05:29:54,462
WELL, LET ME JUST GIVE YOU AN

8253
05:29:54,462 --> 05:29:57,398
EXAMPLE OF WHAT HAPPENS TO THE

8254
05:29:57,398 --> 05:29:59,967
PREVIOUS TWO CASES, HORMONE

8255
05:29:59,967 --> 05:30:02,670
THERAPY AND STATIN THERAPY

8256
05:30:02,670 --> 05:30:05,406
CASES, WHEN WE APPLY THE TARGET

8257
05:30:05,406 --> 05:30:06,641
TRIAL FRAMEWORK TO THE

8258
05:30:06,641 --> 05:30:09,577
OBSERVATIONAL DATA.

8259
05:30:09,577 --> 05:30:12,980
IN BOTH CASES, NOW WE FIND

8260
05:30:12,980 --> 05:30:15,483
RESULTS FULLY COMPATIBLE WITH

8261
05:30:15,483 --> 05:30:17,785
THOSE OF THE RANDOMIZED TRIALS

8262
05:30:17,785 --> 05:30:20,421
BOTH FROM HORMONE THERAPY AND

8263
05:30:20,421 --> 05:30:24,258
STATINS AND CANCER WHERE BARBARA

8264
05:30:24,258 --> 05:30:26,661
DICKERMAN LATER STUDIED USING

8265
05:30:26,661 --> 05:30:30,698
RECORDS THAT SHOWED USING THE

8266
05:30:30,698 --> 05:30:32,266
OBSERVATIONAL DATA WE ALSO FIND

8267
05:30:32,266 --> 05:30:33,968
THE EFFECTS OF STATINS ON

8268
05:30:33,968 --> 05:30:37,905
CANCER, BECAUSE THE TWO EXAMPLES

8269
05:30:37,905 --> 05:30:40,908
HAVE MOSTLY BIASES DUE TO

8270
05:30:40,908 --> 05:30:43,945
INCORRECT DESIGN, NOT DUE TO

8271
05:30:43,945 --> 05:30:46,147
INSUFFICIENT INFORMATION IN THE

8272
05:30:46,147 --> 05:30:47,148
OBSERVATIONAL DATA.

8273
05:30:47,148 --> 05:30:49,450
SO, THE PROBLEM IN THESE TWO

8274
05:30:49,450 --> 05:30:52,286
EXAMPLES THAT I GAVE YOU WASN'T

8275
05:30:52,286 --> 05:30:53,654
LACK OF RANDOMIZATION.

8276
05:30:53,654 --> 05:30:58,025
THE PROBLEM WAS INCORRECT DESIGN

8277
05:30:58,025 --> 05:30:59,860
OF THE OBSERVATIONAL ANALYSIS,

8278
05:30:59,860 --> 05:31:02,496
ESSENTIALLY THE FOLLOW-UP WAS

8279
05:31:02,496 --> 05:31:06,667
NOT STARTED, TIME ZERO WAS NOT

8280
05:31:06,667 --> 05:31:08,769
TIME OF ASSIGNMENT OR THERE WAS

8281
05:31:08,769 --> 05:31:10,404
INFORMATION THAT WAS NOT KNOWN

8282
05:31:10,404 --> 05:31:12,707
AT TIME ZERO, AND THAT WAS USED

8283
05:31:12,707 --> 05:31:14,342
TO CLASSIFY PEOPLE INTO ONE

8284
05:31:14,342 --> 05:31:16,210
GROUP OR THE OTHER GROUP, THINGS

8285
05:31:16,210 --> 05:31:19,280
LIKE WE WOULD NEVER DO IN A

8286
05:31:19,280 --> 05:31:20,114
RANDOMIZED TRIAL.

8287
05:31:20,114 --> 05:31:21,449
SO NOTHING WRONG WITH THE

8288
05:31:21,449 --> 05:31:24,051
OBSERVATIONAL DATA IN THIS CASE,

8289
05:31:24,051 --> 05:31:25,820
AND IN MANY OTHERS, THE PROBLEM

8290
05:31:25,820 --> 05:31:30,524
WAS HOW THE DATA WERE USED.

8291
05:31:30,524 --> 05:31:30,992
OKAY.

8292
05:31:30,992 --> 05:31:33,060
SO, DESIGN BIASES ARE BAD.

8293
05:31:33,060 --> 05:31:37,064
BUT WE KNOW HOW TO ELIMINATE

8294
05:31:37,064 --> 05:31:37,765
THEM.

8295
05:31:37,765 --> 05:31:41,369
WE CAN EXPLICITLY EMULATE TARGET

8296
05:31:41,369 --> 05:31:42,470
TRIAL.

8297
05:31:42,470 --> 05:31:45,539
WE'RE LEFT WITH DATA BIASES,

8298
05:31:45,539 --> 05:31:47,174
SPECIFICALLY CONFOUNDING DUE TOE

8299
05:31:47,174 --> 05:31:48,809
LACK OF RANDOMIZATION.

8300
05:31:48,809 --> 05:31:51,545
HOW BAD IS THAT?

8301
05:31:51,545 --> 05:31:53,948
AND THE FIRST POINT IS TO ANSWER

8302
05:31:53,948 --> 05:31:55,783
THAT QUESTION, WE NEED TO SOLVE

8303
05:31:55,783 --> 05:31:57,852
THE DESIGN BIASES.

8304
05:31:57,852 --> 05:31:59,820
WE CANNOT ASK ABOUT CONFOUNDING

8305
05:31:59,820 --> 05:32:02,556
IN AN OBSERVATIONAL STUDY THAT

8306
05:32:02,556 --> 05:32:06,494
IS NOT DESIGNED WELL BECAUSE TO

8307
05:32:06,494 --> 05:32:08,529
GET BIAS THAT CANNOT BE

8308
05:32:08,529 --> 05:32:12,867
ADJUSTED, STUDIES HAPPEN WITH

8309
05:32:12,867 --> 05:32:15,269
THE DESIGN BIAS, SO THEY ARE SO

8310
05:32:15,269 --> 05:32:20,608
STRONG AND DUE TO STRUCTURE, NO

8311
05:32:20,608 --> 05:32:21,509
POSSIBILITY OF ADJUSTING FOR

8312
05:32:21,509 --> 05:32:23,577
THEM IN MOST CASES.

8313
05:32:23,577 --> 05:32:27,415
SO WE FIRST EMULATE TARGET

8314
05:32:27,415 --> 05:32:28,182
TRIAL, EXPLICITLY, AND

8315
05:32:28,182 --> 05:32:31,018
CONFOUNDING, THAT IS ONE OF THE

8316
05:32:31,018 --> 05:32:31,719
ADVANTAGES OF THE EXPLICIT

8317
05:32:31,719 --> 05:32:33,421
EMULATION OF A TARGET TRIAL THAT

8318
05:32:33,421 --> 05:32:36,290
WE CAN FOCUS ON CONFOUNDING, ON

8319
05:32:36,290 --> 05:32:38,926
THE DATA, WITHOUT HAVING TO BE

8320
05:32:38,926 --> 05:32:42,096
DISTRACTED BY ALL THE OTHER

8321
05:32:42,096 --> 05:32:44,065
BIASES THAT ARE REALLY

8322
05:32:44,065 --> 05:32:45,066
SELF-INFLICTED BIASES.

8323
05:32:45,066 --> 05:32:46,467
THEY HAVE NOTHING TO DO WITH THE

8324
05:32:46,467 --> 05:32:48,102
QUALITY OF THE DATA.

8325
05:32:48,102 --> 05:32:52,807
AND THEN THERE ARE MANY EXAMPLES

8326
05:32:52,807 --> 05:32:55,643
OF TARGET TRIAL -- OF USE OF

8327
05:32:55,643 --> 05:32:59,914
OBSERVATIONAL DATA TO EMULATE A

8328
05:32:59,914 --> 05:33:02,249
TARGET TRIAL IN WHICH RESULTS

8329
05:33:02,249 --> 05:33:05,886
ARE SIMILAR TO THOSE FROM THE

8330
05:33:05,886 --> 05:33:06,253
TRIALS.

8331
05:33:06,253 --> 05:33:07,922
THERE ARE ALSO MANY EXAMPLES, I

8332
05:33:07,922 --> 05:33:11,726
DON'T HAVE TIME TO GO OVER SOME

8333
05:33:11,726 --> 05:33:16,263
OF THEM HERE, IN WHICH

8334
05:33:16,263 --> 05:33:18,299
OBSERVATIONAL EMULATIONS HAPPEN

8335
05:33:18,299 --> 05:33:20,034
BEFORE THE TRIALS WERE CONDUCTED

8336
05:33:20,034 --> 05:33:23,904
AND THEN THE TRIAL ESSENTIALLY

8337
05:33:23,904 --> 05:33:24,572
IS CONFIRMED, OBSERVATIONAL

8338
05:33:24,572 --> 05:33:25,539
STUDIES ARE DONE.

8339
05:33:25,539 --> 05:33:28,843
SO THERE ARE MANY CASES IN WHICH

8340
05:33:28,843 --> 05:33:32,880
WE HAVE -- WE CAN NOW DOCUMENT

8341
05:33:32,880 --> 05:33:34,849
IN WHICH THE REAL WORLD DATA

8342
05:33:34,849 --> 05:33:39,019
WHEN USED WELL IN CASES IN WHICH

8343
05:33:39,019 --> 05:33:40,221
CONFOUNDING IS NOT MASSIVE, OR

8344
05:33:40,221 --> 05:33:45,893
THERE'S VERY GOOD DATA ON

8345
05:33:45,893 --> 05:33:47,528
CONFOUNDERS OR BOTH, THEN OF

8346
05:33:47,528 --> 05:33:49,964
COURSE THIS IS THE IDEAL

8347
05:33:49,964 --> 05:33:51,832
SCENARIO FOR THE USE OF REAL

8348
05:33:51,832 --> 05:33:52,266
WORLD DATA.

8349
05:33:52,266 --> 05:33:58,472
SO LET ME GIVE JUST ONE QUICK

8350
05:33:58,472 --> 05:34:01,442
EXAMPLE, FOR GLP-1-BASED

8351
05:34:01,442 --> 05:34:01,742
THERAPIES.

8352
05:34:01,742 --> 05:34:06,447
AND A FEW YEARS AGO WE SENT WITH

8353
05:34:06,447 --> 05:34:09,316
THE HELP OF COLLEAGUES FROM

8354
05:34:09,316 --> 05:34:13,587
PCORI I WROTE A WHITE PAPER ON

8355
05:34:13,587 --> 05:34:17,758
HOW TO USE OBSERVATIONAL DATA TO

8356
05:34:17,758 --> 05:34:20,728
EMULATE TARGET TRIALS OF

8357
05:34:20,728 --> 05:34:22,730
DIABETES THERAPIES.

8358
05:34:22,730 --> 05:34:24,198
AND THEN SEVERAL GROUPS AROUND

8359
05:34:24,198 --> 05:34:29,336
THE COUNTRY WERE FUNDED BY PCORI

8360
05:34:29,336 --> 05:34:36,243
TO CONDUCT STUDIES THAT OF

8361
05:34:36,243 --> 05:34:38,212
COURSE INVOLVED GLP-1-BASED

8362
05:34:38,212 --> 05:34:39,046
THERAPY.

8363
05:34:39,046 --> 05:34:43,551
SO LET ME DESCRIBE ONE OF THOSE

8364
05:34:43,551 --> 05:34:44,251
STUDIES.

8365
05:34:44,251 --> 05:34:45,986
FIRST LET ME TELL YOU WHAT THE

8366
05:34:45,986 --> 05:34:47,621
TARGET TRIAL IS BECAUSE THE

8367
05:34:47,621 --> 05:34:49,690
FIRST THING IS TO DESIGN TARGET

8368
05:34:49,690 --> 05:34:55,162
TRIAL, THEN WE TALK ABOUT THE

8369
05:34:55,162 --> 05:34:55,696
OBSERVATIONAL DATA.

8370
05:34:55,696 --> 05:34:57,464
THIS IS THE SUMMARY OF THE

8371
05:34:57,464 --> 05:34:59,333
PROTOCOL OF TARGET TRIAL IN

8372
05:34:59,333 --> 05:35:01,535
WHICH WE TAKE PEOPLE WITH

8373
05:35:01,535 --> 05:35:04,038
DIABETES, WHO ARE ON METFORMIN

8374
05:35:04,038 --> 05:35:07,141
AND NEED SECOND THERAPY AND

8375
05:35:07,141 --> 05:35:08,776
THOSE PEOPLE WOULD BE RANDOMIZED

8376
05:35:08,776 --> 05:35:13,113
TO ONE OF THOSE FOUR THERAPIES,

8377
05:35:13,113 --> 05:35:22,990
EITHER GLP-1 R.A. OR OTHERS,

8378
05:35:22,990 --> 05:35:25,926
FOLLOWED TO ESTIMATE RISK OF

8379
05:35:25,926 --> 05:35:36,303
MAJOR CARDIAC EVENTS.

8380
05:35:40,241 --> 05:35:43,477
THIS PCORI STUDY, WHICH COMBINED

8381
05:35:43,477 --> 05:35:46,313
DATA FROM PATIENT HEALTH SYSTEMS

8382
05:35:46,313 --> 05:35:48,649
AND INSURANCE PROVIDERS AROUND

8383
05:35:48,649 --> 05:35:55,422
THE U.S., THAT'S ABOUT 5 MILLION

8384
05:35:55,422 --> 05:35:58,158
PEOPLE WITH DIABETES THAT

8385
05:35:58,158 --> 05:35:59,760
DE-DUPLICATED BECAUSE OF COURSE

8386
05:35:59,760 --> 05:36:02,863
AS WE HAVE HEARD BEFORE SOME

8387
05:36:02,863 --> 05:36:04,832
PEOPLE MAY APPEAR IN MORE THAN

8388
05:36:04,832 --> 05:36:06,901
ONE SYSTEM OVER TIME.

8389
05:36:06,901 --> 05:36:11,972
THEY WERE LINKED TO NATIONAL

8390
05:36:11,972 --> 05:36:13,407
INDEX, MOSTLY ELECTRONIC HEALTH

8391
05:36:13,407 --> 05:36:16,110
RECORDS, THIS IS VERY RICH

8392
05:36:16,110 --> 05:36:19,079
CLINICAL DATA.

8393
05:36:19,079 --> 05:36:21,282
THERE ARE MEASUREMENTS OF HBA1C

8394
05:36:21,282 --> 05:36:27,922
AND MANY OTHER LAB INDICATORS.

8395
05:36:27,922 --> 05:36:28,923
AFTER APPLYING ELIGIBILITY

8396
05:36:28,923 --> 05:36:32,459
CRITERIA OF THE TARGET TRIAL,

8397
05:36:32,459 --> 05:36:39,667
75,000 INDIVIDUALS IN THIS

8398
05:36:39,667 --> 05:36:42,169
DATASET THAT MET CRITERIA,

8399
05:36:42,169 --> 05:36:44,338
15,000 ON GLP-1 THERAPIES.

8400
05:36:44,338 --> 05:36:52,680
AND THIS IS A SUMMARY OF THE

8401
05:36:52,680 --> 05:36:59,353
RESULTS, AS YOU CAN SEE THE RISK

8402
05:36:59,353 --> 05:37:07,394
OF IS LOWEST FOR GLP-1s, AND

8403
05:37:07,394 --> 05:37:13,567
SGLT2s, COMPARED WITH SHUL

8404
05:37:13,567 --> 05:37:20,474
PHON UREAS, THERE ARE MANY OTHER

8405
05:37:20,474 --> 05:37:22,409
EXAMPLES WITH THE DATABASE FOR

8406
05:37:22,409 --> 05:37:23,677
RENAL OUTCOME, ET CETERA.

8407
05:37:23,677 --> 05:37:27,047
ANOTHER EXAMPLE OF THE USE OF

8408
05:37:27,047 --> 05:37:30,117
OBSERVATIONAL DATA IN WHICH

8409
05:37:30,117 --> 05:37:34,021
RESULTS ARE NOT AS CONCLUSIVE,

8410
05:37:34,021 --> 05:37:37,691
NOT AS INFORMATIVE LET ME

8411
05:37:37,691 --> 05:37:38,859
MENTION USE OF RECORDS IN THIS

8412
05:37:38,859 --> 05:37:42,529
CASE FROM THE V.A. TO ESTIMATE

8413
05:37:42,529 --> 05:37:45,799
EFFECTS BARIATRIC SURGERY ON

8414
05:37:45,799 --> 05:37:47,134
CARDIOVASCULAR EVENTS, USING

8415
05:37:47,134 --> 05:37:49,103
EXPLICIT TARGET TRIAL EMULATION.

8416
05:37:49,103 --> 05:37:50,738
AND YOU MAY NOTICE AT THE END OF

8417
05:37:50,738 --> 05:37:54,441
THE TITLE OF THIS PAPER IS A

8418
05:37:54,441 --> 05:37:56,276
QUESTION MARK BECAUSE THAT'S

8419
05:37:56,276 --> 05:37:58,278
REALLY WHAT WE'RE TRYING TO

8420
05:37:58,278 --> 05:38:01,348
DETERMINE HERE, IS IT POSSIBLE

8421
05:38:01,348 --> 05:38:03,217
TO USE OBSERVATIONAL DATA FROM

8422
05:38:03,217 --> 05:38:05,953
ELECTRONIC HEALTH RECORDS TO

8423
05:38:05,953 --> 05:38:06,920
ESTIMATE EFFECT OF BARIATRIC

8424
05:38:06,920 --> 05:38:07,855
SURGERY?

8425
05:38:07,855 --> 05:38:08,789
THERE ARE MANY OBSERVATIONAL

8426
05:38:08,789 --> 05:38:10,124
STUDIES THAT HAVE BEEN PUBLISHED

8427
05:38:10,124 --> 05:38:12,826
IN THE PAST, AND THEY TEND TO

8428
05:38:12,826 --> 05:38:14,495
FIND SOMETIMES A SURPRISINGLY

8429
05:38:14,495 --> 05:38:16,363
BIG EFFECT OF BARIATRIC SURGERY

8430
05:38:16,363 --> 05:38:19,733
ON CORONARY HEART DISEASE.

8431
05:38:19,733 --> 05:38:22,036
IN THIS ANALYSIS WE WENT OVER

8432
05:38:22,036 --> 05:38:23,670
THE PREVIOUS STUDIES.

8433
05:38:23,670 --> 05:38:26,407
WE FOUND PLACES IN WHICH THEY

8434
05:38:26,407 --> 05:38:28,375
DEVIATED FROM WHAT THE TARGET

8435
05:38:28,375 --> 05:38:29,777
TRIAL WOULD HAVE DONE.

8436
05:38:29,777 --> 05:38:31,645
WE DID WHAT THE TARGET TRIAL

8437
05:38:31,645 --> 05:38:33,914
WOULD HAVE DONE AND WE CONCLUDED

8438
05:38:33,914 --> 05:38:38,652
THERE WAS NOT MUCH EVIDENCE OF

8439
05:38:38,652 --> 05:38:41,288
STRONG EFFECT ON CARDIOVASCULAR

8440
05:38:41,288 --> 05:38:42,389
DISEASE OF BARIATRIC SURGERY, SO

8441
05:38:42,389 --> 05:38:45,459
HERE THIS IS AN EXAMPLE THAT I

8442
05:38:45,459 --> 05:38:48,295
WANTED TO SHOW BECAUSE THE

8443
05:38:48,295 --> 05:38:50,164
ANSWER IS WE DON'T REALLY TRUST

8444
05:38:50,164 --> 05:38:52,232
THE OBSERVATIONAL DATA HERE

8445
05:38:52,232 --> 05:38:54,401
BECAUSE THERE'S NOT ENOUGH

8446
05:38:54,401 --> 05:38:55,169
INFORMATION TO REALLY EMULATE

8447
05:38:55,169 --> 05:38:56,170
TARGET TRIAL.

8448
05:38:56,170 --> 05:39:00,674
WE HAD TO MAKE A LOT OF

8449
05:39:00,674 --> 05:39:02,643
DECISIONS BECAUSE FOR EXAMPLE WE

8450
05:39:02,643 --> 05:39:04,845
DON'T KNOW WHEN A PERSON GOES TO

8451
05:39:04,845 --> 05:39:07,247
THE DOCTOR AND WHEN THAT PERSON

8452
05:39:07,247 --> 05:39:09,349
IS ASSIGNED TO THE PROCESS THAT

8453
05:39:09,349 --> 05:39:11,618
MAYBE A YEAR LATER WILL END UP

8454
05:39:11,618 --> 05:39:12,653
WITH SURGERY.

8455
05:39:12,653 --> 05:39:14,588
WHAT HAPPENS IN MANY STUDIES IS

8456
05:39:14,588 --> 05:39:16,023
THEY COMPARE THOSE WHO HAVE

8457
05:39:16,023 --> 05:39:20,494
SURGERY AND THOSE WHO DON'T HAVE

8458
05:39:20,494 --> 05:39:21,595
SURGERY BUT THOSE ARE THE

8459
05:39:21,595 --> 05:39:22,996
PREVIOUS SIX MONTHS OF THOSE

8460
05:39:22,996 --> 05:39:27,634
PEOPLE ARE VERY DIFFERENT AND

8461
05:39:27,634 --> 05:39:31,672
THAT IS NOT TAKEN ACCOUNT IN THE

8462
05:39:31,672 --> 05:39:35,175
OBSERVATIONAL ANALYSIS, MOST

8463
05:39:35,175 --> 05:39:35,809
OBSERVATIONAL ANALYSIS.

8464
05:39:35,809 --> 05:39:39,446
THIS IS AN EXAMPLE TO SAY, LOOK,

8465
05:39:39,446 --> 05:39:40,514
DOESN'T SEEM LIKE THERE'S MUCH

8466
05:39:40,514 --> 05:39:44,685
EFFECT, WHAT WE'LL DO IN A

8467
05:39:44,685 --> 05:39:46,353
TRIAL, BUT WE REALLY NEED

8468
05:39:46,353 --> 05:39:47,321
RANDOMIZED TRIAL.

8469
05:39:47,321 --> 05:39:49,223
IF WE WANT TO ANSWER THIS

8470
05:39:49,223 --> 05:39:52,159
QUESTION, WE'LL HAVE REACHED THE

8471
05:39:52,159 --> 05:39:53,594
LIMITS OF OBSERVATIONAL DATA.

8472
05:39:53,594 --> 05:39:55,429
THERE ARE TOO MANY ASSUMPTIONS

8473
05:39:55,429 --> 05:39:56,663
HERE.

8474
05:39:56,663 --> 05:39:59,500
THE GOOD THING IS THAT IT

8475
05:39:59,500 --> 05:40:02,903
PROVIDES EQUIPOISE FOR A TRIAL,

8476
05:40:02,903 --> 05:40:06,740
IF A TRIAL IS NOT ETHICAL

8477
05:40:06,740 --> 05:40:07,908
BECAUSE BARIATRIC SURGERY LOWERS

8478
05:40:07,908 --> 05:40:10,644
RISK OF HEART DISEASE, WELL,

8479
05:40:10,644 --> 05:40:13,614
ACTUALLY IT'S NOT CLEAR.

8480
05:40:13,614 --> 05:40:15,949
WE NEED THAT TRIAL.

8481
05:40:15,949 --> 05:40:19,753
MY POINT IS THAT OBSERVATIONAL

8482
05:40:19,753 --> 05:40:21,722
DATA ANALYSIS ARE NOT

8483
05:40:21,722 --> 05:40:24,224
NECESSARILY HOPELESS, MANY TIMES

8484
05:40:24,224 --> 05:40:26,360
CAN PROVIDE ACTIONABLE

8485
05:40:26,360 --> 05:40:26,994
INFORMATION.

8486
05:40:26,994 --> 05:40:28,428
AND SOMETIMES THEY CAN'T.

8487
05:40:28,428 --> 05:40:31,165
BUT AT LEAST THEY CAN HELP US

8488
05:40:31,165 --> 05:40:34,201
DECIDE WHEN A TRIAL IS THE ONLY

8489
05:40:34,201 --> 05:40:35,536
WAY TO GO.

8490
05:40:35,536 --> 05:40:37,271
NOW, THERE'S ALWAYS A KEY

8491
05:40:37,271 --> 05:40:40,340
QUESTION HERE, WHICH IS FINE.

8492
05:40:40,340 --> 05:40:43,544
WE USE THE TARGET TRIAL

8493
05:40:43,544 --> 05:40:44,611
FRAMEWORK.

8494
05:40:44,611 --> 05:40:47,114
WE DON'T HAVE DESIGN, BUT WE

8495
05:40:47,114 --> 05:40:49,416
STILL MAY HAVE CONFOUNDING, HOW

8496
05:40:49,416 --> 05:40:53,787
DO WE KNOW WE HAVE SUCCEEDED IN

8497
05:40:53,787 --> 05:40:54,488
ADJUSTING FOR CONFOUNDING?

8498
05:40:54,488 --> 05:40:56,256
WE CAN NEVER KNOW FOR SURE AND

8499
05:40:56,256 --> 05:40:57,357
THAT'S THE PROBLEM.

8500
05:40:57,357 --> 05:41:00,294
THAT'S WHY ALL THE THINGS BEING

8501
05:41:00,294 --> 05:41:04,665
EQUAL WE PREFER RANDOMIZED TRIAL

8502
05:41:04,665 --> 05:41:06,533
OVER OBSERVATIONAL EVOLUTION OF

8503
05:41:06,533 --> 05:41:07,434
THE RANDOMIZED TRIAL.

8504
05:41:07,434 --> 05:41:10,637
AND BUT THERE ARE SOME WAYS IN

8505
05:41:10,637 --> 05:41:14,675
WHICH WE CAN PROVIDE EMPIRICAL

8506
05:41:14,675 --> 05:41:18,278
EVIDENCE THAT THE OBSERVATIONAL

8507
05:41:18,278 --> 05:41:21,114
ANALYSIS IS NOT -- ONE WAY IS BY

8508
05:41:21,114 --> 05:41:23,283
USING NEGATIVE CONTROLS AND WE

8509
05:41:23,283 --> 05:41:26,987
HAVE HEARD ABOUT THAT THIS

8510
05:41:26,987 --> 05:41:27,221
MORNING.

8511
05:41:27,221 --> 05:41:32,025
FOR EXAMPLE, FOR DIABETES

8512
05:41:32,025 --> 05:41:34,228
THERAPIES, ONE POSSIBLE NEGATIVE

8513
05:41:34,228 --> 05:41:36,396
CONTROL OUTCOME IS THE RISK OF

8514
05:41:36,396 --> 05:41:37,431
CORONARY HEART DISEASE IN THE

8515
05:41:37,431 --> 05:41:39,032
FIRST THREE MONTHS OF TREATMENT.

8516
05:41:39,032 --> 05:41:42,002
WE DON'T EXPECT THAT THE

8517
05:41:42,002 --> 05:41:45,005
TREATMENTS WILL HAVE AN EFFECT,

8518
05:41:45,005 --> 05:41:46,974
A VERY SHORTENED EFFECT, IF WE

8519
05:41:46,974 --> 05:41:50,344
FIND SOMETHING THAT LOOKS LIKE A

8520
05:41:50,344 --> 05:41:52,679
VERY SHORT THERAPY EFFECT,

8521
05:41:52,679 --> 05:41:58,218
PEOPLE GETTING GLP-1 BASED

8522
05:41:58,218 --> 05:42:03,657
THERAPIES, AND THAT'S WHERE

8523
05:42:03,657 --> 05:42:06,226
WE'RE FINDING THIS.

8524
05:42:06,226 --> 05:42:11,565
THE OTHER IS BENCHMARKING, A

8525
05:42:11,565 --> 05:42:13,200
TWO-STAGE THINGS.

8526
05:42:13,200 --> 05:42:15,869
FIRST WE USE EFFECT ESTIMATE

8527
05:42:15,869 --> 05:42:17,271
FROM EXISTING TRIALS TO

8528
05:42:17,271 --> 05:42:20,340
BENCHMARK THE EFFECT ESTIMATED

8529
05:42:20,340 --> 05:42:21,875
FROM THE OBSERVATIONAL AND TRY

8530
05:42:21,875 --> 05:42:24,311
TO EMULATE.

8531
05:42:24,311 --> 05:42:28,949
IF WE CAN BENCHMARK THE EFFECT

8532
05:42:28,949 --> 05:42:31,051
FROM OBSERVATIONAL STUDIES TO

8533
05:42:31,051 --> 05:42:32,719
THOSE FROM TRIALS WE CAN GO TO

8534
05:42:32,719 --> 05:42:35,522
THE SECOND STAGE, USE THE

8535
05:42:35,522 --> 05:42:39,926
OBSERVATIONAL DATA TO EXTEND THE

8536
05:42:39,926 --> 05:42:41,461
INFERENCES, TWO THINGS THE TRIAL

8537
05:42:41,461 --> 05:42:43,430
COULD NOT ANSWER.

8538
05:42:43,430 --> 05:42:45,198
MULTIPLE EXAMPLES AT OUR GROUP

8539
05:42:45,198 --> 05:42:46,800
AND OTHER GROUPS HAVE BEEN

8540
05:42:46,800 --> 05:42:47,467
WORKING ON.

8541
05:42:47,467 --> 05:42:51,104
THIS IS NOT AN EASY PROCESS TO

8542
05:42:51,104 --> 05:42:53,507
BENCHMARK BECAUSE MANY TRIALS

8543
05:42:53,507 --> 05:42:58,779
ONLY PUBLISH INTENTION TO TREAT

8544
05:42:58,779 --> 05:43:03,350
EFFECT ESTIMATES BUT CANNOT BE

8545
05:43:03,350 --> 05:43:04,985
BENCHMARKED BECAUSE ESTIMATES

8546
05:43:04,985 --> 05:43:08,288
ARE AFFECTED BY ADHERENCE, AND

8547
05:43:08,288 --> 05:43:10,257
ADHERENCE PATTERNS MAY BE

8548
05:43:10,257 --> 05:43:11,591
DIFFERENT.

8549
05:43:11,591 --> 05:43:13,660
MANY TIMES THE BENCHMARKING WILL

8550
05:43:13,660 --> 05:43:15,996
REQUIRE A REANALYSIS OF TRIAL

8551
05:43:15,996 --> 05:43:19,599
FROM THE DATA TO BE ABLE TO

8552
05:43:19,599 --> 05:43:25,172
COMPARE THAT TO AN OBSERVATIONAL

8553
05:43:25,172 --> 05:43:25,372
DATA.

8554
05:43:25,372 --> 05:43:27,341
AND TO FINISH HERE WITH THIS

8555
05:43:27,341 --> 05:43:31,411
MESSAGE TRIALS AND OBSERVATIONAL

8556
05:43:31,411 --> 05:43:33,046
EMULATIONS ARE COMPLEMENTARY

8557
05:43:33,046 --> 05:43:34,915
APPROACHES.

8558
05:43:34,915 --> 05:43:37,651
WE CAN USE OBSERVATIONAL DATA

8559
05:43:37,651 --> 05:43:39,519
FOR MAKING UNTIL WE HAVE TRIALS,

8560
05:43:39,519 --> 05:43:45,759
CAN USE THE TRIAL TO DESIGN

8561
05:43:45,759 --> 05:43:47,294
BETTER OBSERVATIONAL STUDIES,

8562
05:43:47,294 --> 05:43:49,062
FOR EXAMPLE WITH BENCHMARKING,

8563
05:43:49,062 --> 05:43:52,099
AND CAN USE OBSERVATIONAL

8564
05:43:52,099 --> 05:43:53,433
EMULATION TO ANSWER QUESTIONS

8565
05:43:53,433 --> 05:43:54,868
THE TRIAL COULDN'T.

8566
05:43:54,868 --> 05:43:56,169
THIS IS NOT A COMPETITION.

8567
05:43:56,169 --> 05:43:59,005
THIS IS NOT A COMPETITION

8568
05:43:59,005 --> 05:44:00,107
BETWEEN RANDOMIZED TRIALS AND

8569
05:44:00,107 --> 05:44:01,208
REAL WORLD DATA.

8570
05:44:01,208 --> 05:44:04,244
THERE IS A ROLE FOR BOTH TO PLAY

8571
05:44:04,244 --> 05:44:09,182
IF WE KEEP THE RIGHT BALANCE

8572
05:44:09,182 --> 05:44:09,950
HERE.

8573
05:44:09,950 --> 05:44:12,352
PLEASE KEEP IN MIND THE

8574
05:44:12,352 --> 05:44:13,553
TWO-STAGE PROCESS, FIRST ASK THE

8575
05:44:13,553 --> 05:44:15,122
QUESTION, THEN ANSWER IT.

8576
05:44:15,122 --> 05:44:19,259
DON'T JUMP INTO THE

8577
05:44:19,259 --> 05:44:21,061
OBSERVATIONAL DATA LANGUAGE.

8578
05:44:21,061 --> 05:44:23,830
NO, FIRST WE NEED TO KNOW WHAT

8579
05:44:23,830 --> 05:44:25,065
IS THE EFFECT THAT WE'RE TRYING

8580
05:44:25,065 --> 05:44:26,366
TO ESTIMATE.

8581
05:44:26,366 --> 05:44:28,568
THEN WE DESIGN OUR OBSERVATIONAL

8582
05:44:28,568 --> 05:44:31,738
ANALYSIS AROUND THAT.

8583
05:44:31,738 --> 05:44:34,474
AND IF ANYTIME SOMEONE PROVIDES

8584
05:44:34,474 --> 05:44:38,311
YOU WITH EXACT ESTIMATES FROM

8585
05:44:38,311 --> 05:44:39,413
OBSERVATIONAL DATA ASK THEM WHAT

8586
05:44:39,413 --> 05:44:40,614
IS YOUR TARGET TRIAL.

8587
05:44:40,614 --> 05:44:42,449
IF THEY KNOW THE TARGET TRIAL

8588
05:44:42,449 --> 05:44:44,785
YOU'RE GOING TO HAVE A FRUITFUL

8589
05:44:44,785 --> 05:44:45,118
CONVERSATION.

8590
05:44:45,118 --> 05:44:47,487
IF THEY DON'T, YOU ARE GOING TO

8591
05:44:47,487 --> 05:44:48,455
HELP THEM A LOT.

8592
05:44:48,455 --> 05:44:51,324
SO THANK YOU VERY MUCH.

8593
05:44:51,324 --> 05:44:56,963
AND THESE ARE WHAT I THINK ARE

8594
05:44:56,963 --> 05:44:58,365
OUR FUNDERS.

8595
05:44:58,365 --> 05:44:59,933
>> THANK YOU, MIGUEL.

8596
05:44:59,933 --> 05:45:02,068
NOW I WOULD LIKE TO WELCOME BACK

8597
05:45:02,068 --> 05:45:03,370
ALL THE SPEAKERS.

8598
05:45:03,370 --> 05:45:04,704
WE HAVE A LOT OF QUESTIONS.

8599
05:45:04,704 --> 05:45:09,409
I HOPE I CAN GO THROUGH ALL OF

8600
05:45:09,409 --> 05:45:09,776
THEM.

8601
05:45:09,776 --> 05:45:11,278
IF YOU CAN STOP SHARING YOUR

8602
05:45:11,278 --> 05:45:15,415
SLIDES AND WE CAN HIGHLIGHT ALL

8603
05:45:15,415 --> 05:45:16,316
THE SPEAKERS.

8604
05:45:16,316 --> 05:45:21,455
SO I'LL START WITH AN EASY ONE.

8605
05:45:21,455 --> 05:45:23,557
THIS QUESTION IS FOR ANIA, MAYBE

8606
05:45:23,557 --> 05:45:27,494
FOR LESLEY AS WELL.

8607
05:45:27,494 --> 05:45:30,464
THERE'S A QUESTION ABOUT SORT OF

8608
05:45:30,464 --> 05:45:31,865
REASONABLE COMPARATORS IN THE

8609
05:45:31,865 --> 05:45:36,269
PRAGMATIC TRIALS, THE QUESTION

8610
05:45:36,269 --> 05:45:37,904
IS WHETHER ALL ARE REASON ENABLE

8611
05:45:37,904 --> 05:45:38,672
A PRAGMATIC TRIAL.

8612
05:45:38,672 --> 05:45:42,843
DO WE NEED A TRIAL TO COMPARE

8613
05:45:42,843 --> 05:45:48,315
THE MOST POTENT DRUG VERSUS

8614
05:45:48,315 --> 05:45:50,283
LEAST POTENT, OR SHOULD WE FOCUS

8615
05:45:50,283 --> 05:45:52,919
ON DRUGS THAT ARE SIMILAR

8616
05:45:52,919 --> 05:45:53,286
EFFICACY?

8617
05:45:53,286 --> 05:45:56,189
SO WHAT ARE YOUR THOUGHTS ABOUT

8618
05:45:56,189 --> 05:46:01,761
HOW TO BEST USE PRAGMATIC TRIAL

8619
05:46:01,761 --> 05:46:04,164
SORT OF APPROACH TO STUDY

8620
05:46:04,164 --> 05:46:04,464
MEDICATIONS?

8621
05:46:04,464 --> 05:46:07,801
LESLEY, 

8622
05:46:07,801 --> 05:46:10,070
>> LESLEY, DO YOU WANT TO
GO

8623
05:46:10,070 --> 05:46:10,270
FIRST?

8624
05:46:10,270 --> 05:46:12,472
>>  QUICK ANSWER, WHAT IS
THE

8625
05:46:12,472 --> 05:46:13,707
QUESTION, THE DECISION WE'RE

8626
05:46:13,707 --> 05:46:15,876
TRYING TO INFORM, RIGHT?

8627
05:46:15,876 --> 05:46:18,411
AND THAT WOULD GUIDE THE CHOICE

8628
05:46:18,411 --> 05:46:18,879
OF COMPARATORS.

8629
05:46:18,879 --> 05:46:23,783
I'LL TURN IT OVER TO ANIA TO

8630
05:46:23,783 --> 05:46:27,721
GIVE A CLINICAL ANSWER.

8631
05:46:27,721 --> 05:46:29,456
>> I MEAN, I AGREE, IF YOU
DON'T

8632
05:46:29,456 --> 05:46:30,457
KNOW THE QUESTION IT'S HARD TO

8633
05:46:30,457 --> 05:46:32,092
SAY HOW THE TRIAL SHOULD BE

8634
05:46:32,092 --> 05:46:34,060
DESIGNED OR STUDY SHOULD BE

8635
05:46:34,060 --> 05:46:34,861
DESIGNED.

8636
05:46:34,861 --> 05:46:36,296
YOU KNOW, RIGHT NOW I THINK THE

8637
05:46:36,296 --> 05:46:39,199
INTEREST IS IN TERMS OF THE NEW

8638
05:46:39,199 --> 05:46:39,866
HIGHLY EFFECTIVE MEDICATIONS,

8639
05:46:39,866 --> 05:46:42,602
AND I THINK WHAT I TRIED TO SHOW

8640
05:46:42,602 --> 05:46:44,838
IS WE'RE USING OLDER MEDICATIONS

8641
05:46:44,838 --> 05:46:46,406
AND NEED TO SEE HOW THEY WORK

8642
05:46:46,406 --> 05:46:51,111
BUT  MAY NEED TO USE MORE THAN

8643
05:46:51,111 --> 05:46:51,711
ONE.

8644
05:46:51,711 --> 05:46:55,282
IF AVERAGE EFFICACY IS 5% OR

8645
05:46:55,282 --> 05:46:58,451
MAYBE 7 OR 8% AND NEWER

8646
05:46:58,451 --> 05:47:00,954
MEDICATIONS IS 15 OR 20%, THEN

8647
05:47:00,954 --> 05:47:02,389
IT'S VERY DIFFERENT.

8648
05:47:02,389 --> 05:47:03,957
MECHANISMS ARE ALSO VERY

8649
05:47:03,957 --> 05:47:04,724
DIFFERENT.

8650
05:47:04,724 --> 05:47:06,793
NOT EVERYBODY WILL RESPOND TO

8651
05:47:06,793 --> 05:47:08,895
SOMETHING THAT HAS A GLP-1

8652
05:47:08,895 --> 05:47:10,430
COMPONENT, THERE ARE RARE

8653
05:47:10,430 --> 05:47:11,498
INDIVIDUALS WHO HAVE TROUBLE

8654
05:47:11,498 --> 05:47:14,267
TOLERATING EVEN WHEN WE GO UP

8655
05:47:14,267 --> 05:47:16,336
SLOWLY, VERY RARE, BUT IT DOES

8656
05:47:16,336 --> 05:47:16,736
HAPPEN.

8657
05:47:16,736 --> 05:47:18,738
AND I THINK WE HAVE TO KEEP IN

8658
05:47:18,738 --> 05:47:21,241
MIND THERE'S NOT ONE TYPE OF

8659
05:47:21,241 --> 05:47:22,142
OBESITY.

8660
05:47:22,142 --> 05:47:23,243
SO, THERE ARE MANY DIFFERENT

8661
05:47:23,243 --> 05:47:24,444
OPTIONS IN TERMS OF HOW DO WE

8662
05:47:24,444 --> 05:47:27,414
FIGURE OUT WHAT WORKS BEST FOR

8663
05:47:27,414 --> 05:47:30,917
WHICH PATIENT, AND WHO MAY

8664
05:47:30,917 --> 05:47:34,854
GARNER THE MOST BENEFIT. 

8665
05:47:34,854 --> 05:47:35,622
>> THANK YOU.

8666
05:47:35,622 --> 05:47:39,125
SO, THIS QUESTION COULD BE VERY

8667
05:47:39,125 --> 05:47:41,628
LONG BUT IT'S IMPORTANT.

8668
05:47:41,628 --> 05:47:44,130
MIGUEL AND LESLEY MAKE THE POINT

8669
05:47:44,130 --> 05:47:46,433
ABOUT THE NEED FOR RANDOMIZATION

8670
05:47:46,433 --> 05:47:47,667
FOR CERTAIN QUESTIONS.

8671
05:47:47,667 --> 05:47:52,238
BUT WHAT STRUCK ME IS THAT WHEN

8672
05:47:52,238 --> 05:47:54,641
I THINK ABOUT COMPARISONS THAT

8673
05:47:54,641 --> 05:47:56,610
REQUIRE RANDOMIZATION IT'S USUAL

8674
05:47:56,610 --> 05:47:58,278
THROW COMPARE DIFFERENT

8675
05:47:58,278 --> 05:47:59,279
MODALITIES, RIGHT?  COMPARING

8676
05:47:59,279 --> 05:48:00,513
ONE AOM VERSUS ANOTHER EVEN

8677
05:48:00,513 --> 05:48:04,284
THOUGH IT'S DIFFICULT AS WE JUST

8678
05:48:04,284 --> 05:48:08,955
DISCUSSED IT'S EASIER TO

8679
05:48:08,955 --> 05:48:10,423
COMPARED TO PAIRING WITH

8680
05:48:10,423 --> 05:48:13,960
BARIATRIC SURGERY OR WITH

8681
05:48:13,960 --> 05:48:14,728
LIFESTYLE BEHAVIORAL TREATMENTS.

8682
05:48:14,728 --> 05:48:23,803
BUT AT THE SAME TIME, IT'S HARD

8683
05:48:23,803 --> 05:48:26,006
TO RECRUIT PATIENTS.

8684
05:48:26,006 --> 05:48:27,874
IN THIS CASE, REAL WORLD DATA

8685
05:48:27,874 --> 05:48:32,479
STUDY MIGHT NOT BE FEASIBLE,

8686
05:48:32,479 --> 05:48:34,080
PRAGMATIC TRIAL IS ALSO

8687
05:48:34,080 --> 05:48:36,182
CHALLENGED, TRYING TO FIGURE OUT

8688
05:48:36,182 --> 05:48:38,685
IF THERE'S AN INTEREST TO

8689
05:48:38,685 --> 05:48:39,886
COMPARE TREATMENT MODALITIES,

8690
05:48:39,886 --> 05:48:41,688
LET'S SAY DRUG VERSUS NON-DRUG

8691
05:48:41,688 --> 05:48:43,189
TREATMENT HOW DO WE DO THIS?

8692
05:48:43,189 --> 05:48:51,031
THE QUESTION IS FOR EVERYONE.

8693
05:48:51,031 --> 05:48:53,400
>> I'LL START AND SAY,
MIGUEL, I

8694
05:48:53,400 --> 05:48:55,535
APPRECIATED THE WAY YOU ENDED BY

8695
05:48:55,535 --> 05:48:57,237
TALKING ABOUT LIKE THERE ARE A

8696
05:48:57,237 --> 05:48:59,072
COUPLE STEPS HERE, RIGHT?

8697
05:48:59,072 --> 05:49:02,809
I THINK WHAT YOU HIGHLIGHTED IN

8698
05:49:02,809 --> 05:49:05,745
THE PAPER THAT YOU SHOWED

8699
05:49:05,745 --> 05:49:07,414
COMPARING BARIATRIC SURGERY TO

8700
05:49:07,414 --> 05:49:09,916
MEDICATION THERAPY WAS LIKE

8701
05:49:09,916 --> 05:49:12,752
THAT'S WHERE A TARGET TRIAL

8702
05:49:12,752 --> 05:49:14,888
EMULATION STUDY CAN REALLY LAY

8703
05:49:14,888 --> 05:49:18,224
THE GROUND WORK FOR A RANDOMIZED

8704
05:49:18,224 --> 05:49:20,326
TRIAL AND DEMONSTRATE LIKE TURNS

8705
05:49:20,326 --> 05:49:22,529
OUT WE ACTUALLY HAVE EQUIPOISE,

8706
05:49:22,529 --> 05:49:22,862
RIGHT?

8707
05:49:22,862 --> 05:49:25,999
I THINK THAT WAS AN ELEGANT WAY

8708
05:49:25,999 --> 05:49:28,501
OF SHOWING HOW ONE CAN INFORM

8709
05:49:28,501 --> 05:49:31,404
THE OTHER.

8710
05:49:31,404 --> 05:49:32,005
>> RIGHT.

8711
05:49:32,005 --> 05:49:35,208
AND THE CHOICE BETWEEN GROUPS

8712
05:49:35,208 --> 05:49:38,311
HERE IS REALLY DICTATED BY WHAT

8713
05:49:38,311 --> 05:49:38,778
THE QUESTION IS.

8714
05:49:38,778 --> 05:49:42,982
IF THE QUESTION HAS BEEN ASKED

8715
05:49:42,982 --> 05:49:45,085
FOR CLINICAL REASONS, BASED ON

8716
05:49:45,085 --> 05:49:47,153
DOCTORS, THEY HAVE NO INTEREST

8717
05:49:47,153 --> 05:49:49,889
IN COMPARING TWO THINGS THAT

8718
05:49:49,889 --> 05:49:53,626
THEY ARE NEVER GOING TO CONSIDER

8719
05:49:53,626 --> 05:49:55,462
AS ALTERNATIVE THERAPY, IF THE

8720
05:49:55,462 --> 05:49:59,833
QUESTION IS ASKED BY REGULATOR

8721
05:49:59,833 --> 05:50:02,368
SIMILAR CONSIDERATIONS APPLY.

8722
05:50:02,368 --> 05:50:05,672
YOU DON'T WANT TO COMPARE ONE

8723
05:50:05,672 --> 05:50:06,673
TREATMENT VERSUS PLACEBO WHEN

8724
05:50:06,673 --> 05:50:09,709
REALLY THERE IS AN EXISTING

8725
05:50:09,709 --> 05:50:12,979
TREATMENT THAT WORKS WELL, THEN

8726
05:50:12,979 --> 05:50:15,048
IT HAS TO BE TO HAVE COMPARISON,

8727
05:50:15,048 --> 05:50:16,716
THAT'S THE ONLY THING THAT MAKES

8728
05:50:16,716 --> 05:50:17,917
SENSE FROM CLINICAL POINT OF

8729
05:50:17,917 --> 05:50:19,319
VIEW, EVEN THOUGH IT'S NOT

8730
05:50:19,319 --> 05:50:22,155
ALWAYS LIKE THAT EVEN FROM A

8731
05:50:22,155 --> 05:50:24,057
REGULATORY POINT OF VIEW, WE

8732
05:50:24,057 --> 05:50:25,692
SHOULD CONSIDER SOME CHANGES

8733
05:50:25,692 --> 05:50:26,593
THERE.

8734
05:50:26,593 --> 05:50:29,629
BUT THIS IS SOMETHING THAT

8735
05:50:29,629 --> 05:50:31,598
APPLIES TO ANY TYPE OF STUDY

8736
05:50:31,598 --> 05:50:35,535
DESIGN BECAUSE THAT IS OF COURSE

8737
05:50:35,535 --> 05:50:37,704
A QUESTION OF INTEREST, WE CAN

8738
05:50:37,704 --> 05:50:39,038
DISCUSS WHETHER IN THE REAL

8739
05:50:39,038 --> 05:50:41,341
WORLD THOSE THINGS ARE REALLY

8740
05:50:41,341 --> 05:50:41,674
ALTERNATIVES.

8741
05:50:41,674 --> 05:50:44,511
IF THEY ARE NOT CONSIDERED

8742
05:50:44,511 --> 05:50:48,448
ALTERNATIVES BY DOCTORS AND

8743
05:50:48,448 --> 05:50:51,384
YOU'RE GIVING TREATMENT A AND B

8744
05:50:51,384 --> 05:50:52,819
TO DIFFERENT PATIENTS DIFFICULT

8745
05:50:52,819 --> 05:50:54,220
TO ANSWER WITH OBSERVATIONAL

8746
05:50:54,220 --> 05:50:54,454
DATA.

8747
05:50:54,454 --> 05:51:04,497
THIS MORNING WE HEARD ABOUT

8748
05:51:04,497 --> 05:51:07,901
EXAMPLE FOR COVID, TRIALS SHOWED

8749
05:51:07,901 --> 05:51:10,870
IT WORKED VERY WELL, BUT

8750
05:51:10,870 --> 05:51:12,405
OBSERVATIONAL STUDY PUBLISHED

8751
05:51:12,405 --> 05:51:14,808
SIX MONTHS BEFORE THE TRIAL WAS

8752
05:51:14,808 --> 05:51:15,175
FINISHED.

8753
05:51:15,175 --> 05:51:18,845
SAME THING, THAT WAS A PERFECT

8754
05:51:18,845 --> 05:51:20,580
EXAMPLE BECAUSE THERE WAS

8755
05:51:20,580 --> 05:51:20,880
CONFOUNDING.

8756
05:51:20,880 --> 05:51:22,549
DOCTORS HAD NO IDEA WHETHER IT

8757
05:51:22,549 --> 05:51:26,085
WORKED OR NOT, USING MORE OR

8758
05:51:26,085 --> 05:51:27,921
LESS RANDOM, SOME HOSPITALS

8759
05:51:27,921 --> 05:51:30,990
USING IT ONLY WHEN THEY HAD IT.

8760
05:51:30,990 --> 05:51:33,726
THAT'S PERFECT SETTING FOR

8761
05:51:33,726 --> 05:51:34,994
OBSERVATIONAL STUDY.

8762
05:51:34,994 --> 05:51:37,130
WHAT THE TRIAL DID WAS CONFIRM

8763
05:51:37,130 --> 05:51:41,835
WHAT OBSERVATIONAL STUDIES

8764
05:51:41,835 --> 05:51:42,468
FOUND.

8765
05:51:42,468 --> 05:51:43,603
IT WAS IMPOSSIBLE, VERY

8766
05:51:43,603 --> 05:51:45,338
CONFOUNDING IN THAT CASE.

8767
05:51:45,338 --> 05:51:47,540
THAT'S ONE EXTREME.

8768
05:51:47,540 --> 05:51:49,809
THE OTHER EXTREME IS COMPARING

8769
05:51:49,809 --> 05:51:51,477
TWO THERAPIES WITH DIFFERENT

8770
05:51:51,477 --> 05:51:52,278
INDICATIONS REALLY, THERE'S NO

8771
05:51:52,278 --> 05:51:55,081
WAY WE CAN DO IT WITH

8772
05:51:55,081 --> 05:51:56,616
OBSERVATIONAL DATA.

8773
05:51:56,616 --> 05:51:59,886
>> AND I'LL JUST ADD IN
TERMS OF

8774
05:51:59,886 --> 05:52:02,922
PATIENTS AND THEIR PREFERENCE

8775
05:52:02,922 --> 05:52:04,290
FOR TREATMENT, OBVIOUSLY A LOT

8776
05:52:04,290 --> 05:52:06,726
OF TIME PATIENTS WILL KNOW, AND

8777
05:52:06,726 --> 05:52:07,994
OBVIOUSLY THOSE TREATMENTS WILL

8778
05:52:07,994 --> 05:52:09,963
BE DIFFERENT WHETHER A

8779
05:52:09,963 --> 05:52:11,831
MEDICATION OR SURGERY.

8780
05:52:11,831 --> 05:52:13,566
WITHIN CLINICAL CARE WE OF

8781
05:52:13,566 --> 05:52:15,635
COURSE DEMONSTRATE AND DISCUSS

8782
05:52:15,635 --> 05:52:17,403
WITH PATIENTS THAT CONTINUUM OF

8783
05:52:17,403 --> 05:52:18,504
CARE, THEY MAY REQUIRE ONE

8784
05:52:18,504 --> 05:52:21,975
TREATMENT AT ONE POINT IN THEIR

8785
05:52:21,975 --> 05:52:24,410
LIFE, ANOTHER TREATMENT AND ITS

8786
05:52:24,410 --> 05:52:24,911
ADDITIVE.

8787
05:52:24,911 --> 05:52:29,782
IF YOU ARE COMPARING OR LOOKING

8788
05:52:29,782 --> 05:52:32,318
AT TWO TREATMENTS THAT ARE, YOU

8789
05:52:32,318 --> 05:52:33,720
KNOW, QUITE DIFFERENT, IT'S

8790
05:52:33,720 --> 05:52:35,121
REALLY IMPORTANT TO KNOW WHAT

8791
05:52:35,121 --> 05:52:36,122
YOU'RE MEASURING REGARDLESS OF

8792
05:52:36,122 --> 05:52:39,292
WHAT TYPE OF TRIAL YOU'RE

8793
05:52:39,292 --> 05:52:40,026
LOOKING AT BECAUSE, FOR EXAMPLE,

8794
05:52:40,026 --> 05:52:43,496
IF YOU WANT TO LOOK AT IMMEDIATE

8795
05:52:43,496 --> 05:52:44,697
ANTI-INFLAMMATORY EFFECTS COMING

8796
05:52:44,697 --> 05:52:46,232
ABOUT AND WE'RE SEEING

8797
05:52:46,232 --> 05:52:48,868
POTENTIALLY WITH THESE NEW

8798
05:52:48,868 --> 05:52:49,969
MEDICATIONS, IF WE'RE NOT

8799
05:52:49,969 --> 05:52:51,604
MEASURING THAT WE CAN'T COMPARE

8800
05:52:51,604 --> 05:52:51,971
THAT.

8801
05:52:51,971 --> 05:52:53,539
WHAT IS HAPPENING IN BARIATRIC

8802
05:52:53,539 --> 05:52:54,607
SURGERY, RIGHT?

8803
05:52:54,607 --> 05:52:56,609
AND WHAT DEGREE OF THE EFFECT IS

8804
05:52:56,609 --> 05:52:57,944
FROM THE WEIGHT REDUCTION

8805
05:52:57,944 --> 05:52:58,811
ITSELF, RIGHT?

8806
05:52:58,811 --> 05:53:03,016
BECAUSE WE SEE WEIGHT REDUCTION,

8807
05:53:03,016 --> 05:53:04,617
SIGNIFICANT DEGREES WITH SURGERY

8808
05:53:04,617 --> 05:53:06,252
AND MEDICATION.

8809
05:53:06,252 --> 05:53:08,288
BUT WHERE THE ADDITIONAL EFFECT

8810
05:53:08,288 --> 05:53:10,523
OF THE AGENTS THEMSELVES THAT

8811
05:53:10,523 --> 05:53:13,726
MAY NOT BE HAD WITH BARIATRIC

8812
05:53:13,726 --> 05:53:14,827
SURGERY ALONE, FOR EXAMPLE,

8813
05:53:14,827 --> 05:53:16,896
DIRECT EFFECTS ON THE BETA CELL

8814
05:53:16,896 --> 05:53:18,631
OR ISLET WHICH IMMEDIATELY OCCUR

8815
05:53:18,631 --> 05:53:21,367
WITH THE NEW CLASS OF MEDICATION

8816
05:53:21,367 --> 05:53:23,670
SO I THINK IT'S INCREDIBLY

8817
05:53:23,670 --> 05:53:24,771
IMPORTANT A PRIORI TO REALLY

8818
05:53:24,771 --> 05:53:27,040
KNOW WHAT YOU'RE GOING TO

8819
05:53:27,040 --> 05:53:28,474
MEASURE AND, AGAIN, THAT COMES

8820
05:53:28,474 --> 05:53:31,844
BACK TO WHAT IS YOUR QUESTION,

8821
05:53:31,844 --> 05:53:32,045
YEAH.

8822
05:53:32,045 --> 05:53:34,814
>> YES, YES, YES.

8823
05:53:34,814 --> 05:53:36,115
AS YOU REMEMBER, MIGUEL TELLING

8824
05:53:36,115 --> 05:53:37,784
ME ASKING THE RIGHT QUESTION IS

8825
05:53:37,784 --> 05:53:41,621
50% OF THE BATTLE IF NOT MORE

8826
05:53:41,621 --> 05:53:41,754
.

8827
05:53:41,754 --> 05:53:47,193
ALL THREE OF YOU MENTIONED

8828
05:53:47,193 --> 05:53:55,969
STAKEHOLDER ENGAGEMENT.

8829
05:53:55,969 --> 05:53:58,338
ANIA, YOUR EXAMPLE HELPED US

8830
05:53:58,338 --> 05:53:59,672
CRYSTALLIZE THIS NOTION WE'RE

8831
05:53:59,672 --> 05:54:02,408
NOT DEALING WITH DATA, SO FOR

8832
05:54:02,408 --> 05:54:06,245
MANY OF US, IT'S EASY TO FORGET

8833
05:54:06,245 --> 05:54:11,617
THIS IS AN IMPERFECT REFLECTION

8834
05:54:11,617 --> 05:54:13,686
OF PATIENTS' LIVED EXPERIENCES.

8835
05:54:13,686 --> 05:54:16,622
DO YOU HAVE ANY EXAMPLES WHICH

8836
05:54:16,622 --> 05:54:18,391
STAKEHOLDER ENGAGEMENT HAS

8837
05:54:18,391 --> 05:54:20,493
WORKED WELL, MEANING NOT ONLY

8838
05:54:20,493 --> 05:54:21,561
INFORMED THE QUESTION WE SHOULD

8839
05:54:21,561 --> 05:54:24,364
BE ASKING BUT ALSO HELP US

8840
05:54:24,364 --> 05:54:28,301
DESIGN THE STUDY SO THAT THE

8841
05:54:28,301 --> 05:54:29,335
STUDY CAN REALLY ANSWER THE

8842
05:54:29,335 --> 05:54:29,902
QUESTION.

8843
05:54:29,902 --> 05:54:35,675
THIS AGAIN IS FOR ALL THREE

8844
05:54:35,675 --> 05:54:36,242
SPEAKERS.

8845
05:54:36,242 --> 05:54:37,310
>> I WILL BRING FORWARD
THE

8846
05:54:37,310 --> 05:54:39,412
EXPERIENCE WE HAD WITH THE

8847
05:54:39,412 --> 05:54:40,613
ADAPTABLE TRIAL, WHICH WAS

8848
05:54:40,613 --> 05:54:42,682
COMPARING HIGH DOSE VERSUS LOW

8849
05:54:42,682 --> 05:54:45,418
DOSE ASPIRIN FOR SECONDARY

8850
05:54:45,418 --> 05:54:46,886
PREVENTION OF CARDIOVASCULAR

8851
05:54:46,886 --> 05:54:47,854
EVENTS.

8852
05:54:47,854 --> 05:54:52,992
THAT WAS A PCORI-FUNDED STUDY

8853
05:54:52,992 --> 05:54:56,162
WHERE WE ENGAGED PATIENTS AS

8854
05:54:56,162 --> 05:54:58,031
REAL PARTICIPANTS, AND THAT

8855
05:54:58,031 --> 05:55:00,433
GROUP OF PATIENTS WAS ENGAGED

8856
05:55:00,433 --> 05:55:02,402
FROM THE BEGINNING.

8857
05:55:02,402 --> 05:55:04,037
THEY HELPED US WITH DESIGN.

8858
05:55:04,037 --> 05:55:05,805
THEY HELPED US WITH THINKING

8859
05:55:05,805 --> 05:55:07,874
ABOUT HOW TO RECRUIT.

8860
05:55:07,874 --> 05:55:09,375
I MEAN, TRULY EVERY ASPECT OF

8861
05:55:09,375 --> 05:55:11,277
THE STUDY THEY WEIGHED IN ON,

8862
05:55:11,277 --> 05:55:12,812
INCLUDING LIKE HOW TO EXPLAIN

8863
05:55:12,812 --> 05:55:14,247
THE RESULTS, RIGHT?

8864
05:55:14,247 --> 05:55:17,850
HOW TO REPORT THE RESULTS.

8865
05:55:17,850 --> 05:55:20,820
SO THAT'S OFTEN THE EXAMPLE THAT

8866
05:55:20,820 --> 05:55:24,390
WE USE IN THE PRAGMATIC TRIAL

8867
05:55:24,390 --> 05:55:24,624
SPACES.

8868
05:55:24,624 --> 05:55:25,958
THAT WAS AN EARLY EXAMPLE.

8869
05:55:25,958 --> 05:55:27,927
THERE ARE MANY, MANY THAT HAVE

8870
05:55:27,927 --> 05:55:30,663
ACCUMULATED OVER TIME AS WE'VE

8871
05:55:30,663 --> 05:55:33,066
REALLY EXPERIENCED THE VALUE OF

8872
05:55:33,066 --> 05:55:34,801
BRINGING THOSE PERSPECTIVES IN.

8873
05:55:34,801 --> 05:55:37,637
I'M SURE, YOU KNOW, ANIA, YOU

8874
05:55:37,637 --> 05:55:39,305
AND MIGUEL HAVE PLENTY OF

8875
05:55:39,305 --> 05:55:40,306
EXAMPLES TOO.

8876
05:55:40,306 --> 05:55:45,678
>> YEAH, I MEAN, I AGREE 
AGREE.

8877
05:55:45,678 --> 05:55:49,682
IF THAT'S THE ONLY TAKEHOME FROM

8878
05:55:49,682 --> 05:55:51,884
THE TALK, TO ENGAGE PATIENTS AS

8879
05:55:51,884 --> 05:55:53,619
PARTICIPANTS REGARDSLESS OF THE

8880
05:55:53,619 --> 05:55:55,488
TRIAL WE'RE DOING BECAUSE

8881
05:55:55,488 --> 05:55:56,789
ULTIMATELY WE CAN ONLY INFER

8882
05:55:56,789 --> 05:55:58,124
FROM THEIR LIVED EXPERIENCES AND

8883
05:55:58,124 --> 05:55:58,891
WHAT THEY ARE ACTUALLY

8884
05:55:58,891 --> 05:55:59,859
INTERESTED IN.

8885
05:55:59,859 --> 05:56:02,495
I REALLY DON'T THINK THAT WE DO

8886
05:56:02,495 --> 05:56:03,830
THAT ENOUGH.

8887
05:56:03,830 --> 05:56:07,600
AND WHAT  BRINGS OUR PATIENTS

8888
05:56:07,600 --> 05:56:08,868
BACK IS WHAT THEY ARE

8889
05:56:08,868 --> 05:56:10,870
EXPERIENCING, QUALITY OF LIFE IS

8890
05:56:10,870 --> 05:56:12,038
WHAT THEY REALLY -- OF COURSE

8891
05:56:12,038 --> 05:56:13,239
IT'S HEALTH AND EVERYTHING BUT

8892
05:56:13,239 --> 05:56:15,741
HOW ARE THEY ABLE TO LIVE THEIR

8893
05:56:15,741 --> 05:56:17,610
LIFE TO THE FULLEST WITH THE

8894
05:56:17,610 --> 05:56:23,082
CARE THAT WE PROVIDE SO I

8895
05:56:23,082 --> 05:56:28,221
COULDN'T AGREE MORE.

8896
05:56:28,221 --> 05:56:33,259
>> ALONG THESE LINES WE
HAVE A

8897
05:56:33,259 --> 05:56:36,295
PCORI-FUNDED PROJECT, WE ENGAGE

8898
05:56:36,295 --> 05:56:39,398
PATIENTS, HOW SHOULD WE ANALYZE

8899
05:56:39,398 --> 05:56:40,299
DATA?

8900
05:56:40,299 --> 05:56:43,870
AND SO WE HAVE FOCUS GROUPS WITH

8901
05:56:43,870 --> 05:56:48,708
PATIENTS, AND WE -- FROM THE

8902
05:56:48,708 --> 05:56:52,445
HOSPITALS AROUND HERE, WE TAUGHT

8903
05:56:52,445 --> 05:56:54,614
THEM THE PROTOCOL EFFECT, WE

8904
05:56:54,614 --> 05:56:56,382
EXPLAIN WHY PEOPLE WANT TO USE

8905
05:56:56,382 --> 05:56:59,652
INTENTION TO TREAT EFFECTS FOR

8906
05:56:59,652 --> 05:57:02,054
TRIALS AND THEY UNDERSTOOD.

8907
05:57:02,054 --> 05:57:07,426
WE USED A NON-TECHNICAL LANGUAGE

8908
05:57:07,426 --> 05:57:08,995
BUT WE UNDERSTAND, BUT THAT'S

8909
05:57:08,995 --> 05:57:11,297
NOT WHAT WE WANT BECAUSE YOU

8910
05:57:11,297 --> 05:57:13,699
WEREN'T GIVING US THE EFFECT IN

8911
05:57:13,699 --> 05:57:17,103
THE STUDY WHICH 20%, 30% OF

8912
05:57:17,103 --> 05:57:19,539
PEOPLE, 40% ARE NOT TAKING A

8913
05:57:19,539 --> 05:57:21,607
DRUG, CONTAMINATED EFFECT, YEAH,

8914
05:57:21,607 --> 05:57:22,575
BUT PEOPLE SAY THAT'S A

8915
05:57:22,575 --> 05:57:24,343
REFLECTION OF WHAT HAPPENS IN

8916
05:57:24,343 --> 05:57:25,344
REAL LIFE.

8917
05:57:25,344 --> 05:57:30,483
YES, BUT AS A PATIENT, THAT'S --

8918
05:57:30,483 --> 05:57:32,018
I DON'T CARE, I WANT TO KNOW IF

8919
05:57:32,018 --> 05:57:33,419
I TAKE THE TREATMENT.

8920
05:57:33,419 --> 05:57:35,721
DON'T GIVE ME THE EFFECT OF

8921
05:57:35,721 --> 05:57:37,023
STUDYING 40% OF PEOPLE THAT

8922
05:57:37,023 --> 05:57:38,558
DIDN'T TAKE THE TREATMENT.

8923
05:57:38,558 --> 05:57:40,626
WHAT IF I TAKE IT?

8924
05:57:40,626 --> 05:57:43,362
SO THIS IS ONE OF THE REASONS

8925
05:57:43,362 --> 05:57:45,464
ACTUALLY THAT WE USE TO PROPOSE

8926
05:57:45,464 --> 05:57:55,308
THAT IN ALL TRIALS WE EXAMINE

8927
05:57:55,308 --> 05:57:58,477
PROTOCOL EFFECT, A LITTLE BIT

8928
05:57:58,477 --> 05:58:02,215
MORE SOPHISTICATED.

8929
05:58:02,215 --> 05:58:04,483
SO, YES, HAVING THIS INPUT IS

8930
05:58:04,483 --> 05:58:07,353
VERY HELPFUL FOR ALL OF US.

8931
05:58:07,353 --> 05:58:09,088
>> THANK YOU.

8932
05:58:09,088 --> 05:58:12,959
NEXT QUESTION AGAIN IS FOR ALL

8933
05:58:12,959 --> 05:58:13,893
SPEAKERS.

8934
05:58:13,893 --> 05:58:15,428
AGAIN, JUST TRYING TO RECONCILE

8935
05:58:15,428 --> 05:58:17,863
DIFFERENT THINGS THAT WE HEARD

8936
05:58:17,863 --> 05:58:18,231
TODAY.

8937
05:58:18,231 --> 05:58:21,701
SO, ON ONE HAND WE ALL RECOGNIZE

8938
05:58:21,701 --> 05:58:24,971
THAT WE NEED STUDIES THAT LOOK

8939
05:58:24,971 --> 05:58:25,571
AT LONG-TERM OUTCOMES.

8940
05:58:25,571 --> 05:58:29,041
ON THE OTHER HAND, WE ALSO

8941
05:58:29,041 --> 05:58:32,311
RECOGNIZE THAT THE LANDSCAPE IS

8942
05:58:32,311 --> 05:58:33,613
SHIFTING VERY QUICKLY IN THIS

8943
05:58:33,613 --> 05:58:34,080
AREA.

8944
05:58:34,080 --> 05:58:39,752
SO HOW DO WE MAKE SURE THAT

8945
05:58:39,752 --> 05:58:40,720
STUDY OR PRAGMATIC TRIALS AT THE

8946
05:58:40,720 --> 05:58:42,488
END OF THE STUDY THE RESULT WILL

8947
05:58:42,488 --> 05:58:44,890
BE RELEVANT OR HOW DO WE MAKE

8948
05:58:44,890 --> 05:58:47,526
SURE THAT WE INCORPORATE THE

8949
05:58:47,526 --> 05:58:49,161
CHANGING LANDSCAPE IN OUR

8950
05:58:49,161 --> 05:58:49,395
DESIGN?

8951
05:58:49,395 --> 05:58:51,264
AND, YOU KNOW, THERE'S ALWAYS

8952
05:58:51,264 --> 05:58:53,332
THIS THING ABOUT HAVING TO

8953
05:58:53,332 --> 05:58:54,767
REGISTER YOUR TRIAL OR PROTOCOL

8954
05:58:54,767 --> 05:58:57,937
BEFORE YOU DO THE STUDY,

8955
05:58:57,937 --> 05:58:59,038
AMENDMENTS DOWN THE ROAD, SO

8956
05:58:59,038 --> 05:59:05,811
HELP US FIGURE OUT HOW TO DO A

8957
05:59:05,811 --> 05:59:09,615
STUDY THAT'S ROBUST FOR

8958
05:59:09,615 --> 05:59:14,353
LONG-TERM OUTCOMES BUT

8959
05:59:14,353 --> 05:59:15,221
ACCOMMODATING RAPIDLY CHANGING

8960
05:59:15,221 --> 05:59:15,488
LANDSCAPE?

8961
05:59:15,488 --> 05:59:18,457
>>  I DON'T THINK IT'S
POSSIBLE.

8962
05:59:18,457 --> 05:59:20,993
I THINK IN THE BACKGROUND

8963
05:59:20,993 --> 05:59:21,994
THERAPIES KEEP CHANGING, YOU

8964
05:59:21,994 --> 05:59:25,631
HAVE TO KEEP DOING STUDIES.

8965
05:59:25,631 --> 05:59:28,234
THAT'S HOW I'D SAY IT.

8966
05:59:28,234 --> 05:59:31,370
OF COURSE, THAT IS -- THAT MAY

8967
05:59:31,370 --> 05:59:34,006
BE -- YOU COULD HAVE FASTER

8968
05:59:34,006 --> 05:59:36,409
REACTION, WHERE YOU'RE USING

8969
05:59:36,409 --> 05:59:37,209
OBSERVATIONAL STUDIES, WHEN

8970
05:59:37,209 --> 05:59:38,944
YOU'RE DOING TRIALS.

8971
05:59:38,944 --> 05:59:42,882
BUT THERE'S ALSO THIS

8972
05:59:42,882 --> 05:59:44,750
POSSIBILITY THAT WE DISCUSSED

8973
05:59:44,750 --> 05:59:50,323
WHEN WE TALK ABOUT BENCHMARKING,

8974
05:59:50,323 --> 05:59:53,059
WHEN SOMETHING THAT WE COULD

8975
05:59:53,059 --> 05:59:56,228
CONSIDER IS HAVING AN ORGANIZED

8976
05:59:56,228 --> 06:00:00,032
SYSTEM IN WHICH THE TRIAL, TYPE

8977
06:00:00,032 --> 06:00:02,001
OF TRIAL, LESLEY WAS STUDYING,

8978
06:00:02,001 --> 06:00:06,105
MAYBE HAS ONE YEAR OF FOLLOW-UP.

8979
06:00:06,105 --> 06:00:08,474
SO, WE CAN DO MORE OF THOSE.

8980
06:00:08,474 --> 06:00:10,676
AND FASTER.

8981
06:00:10,676 --> 06:00:12,978
AND THEN WE USE THE REAL WORLD

8982
06:00:12,978 --> 06:00:14,380
DATA TO BENCHMARK TO ONE YEAR.

8983
06:00:14,380 --> 06:00:16,382
IF WE GET THE SAME RESULT FOR

8984
06:00:16,382 --> 06:00:18,584
ONE YEAR WE CAN USE THE

8985
06:00:18,584 --> 06:00:20,086
OBSERVATIONAL DATA TO EXTEND TO

8986
06:00:20,086 --> 06:00:21,854
THREE OR FIVE YEARS.

8987
06:00:21,854 --> 06:00:24,423
SO THAT WE DON'T HAVE TO DO

8988
06:00:24,423 --> 06:00:26,792
FIVE-YEAR TRIALS ALL THE TIME.

8989
06:00:26,792 --> 06:00:29,095
WE CAN DO SHORTER TRIALS, USE

8990
06:00:29,095 --> 06:00:31,397
THEM AS BENCHMARK FOR THE REAL

8991
06:00:31,397 --> 06:00:32,732
WORLD DATA AND USE THE REAL

8992
06:00:32,732 --> 06:00:34,033
WORLD DATA FOR LONGER FOLLOW-UP.

8993
06:00:34,033 --> 06:00:37,203
AND IF WE CAN DO THAT IN SOME

8994
06:00:37,203 --> 06:00:40,139
WAY THAT IS NOT JUST HAPHAZARD,

8995
06:00:40,139 --> 06:00:41,974
THAT SOMEONE DOES A TRIAL, A

8996
06:00:41,974 --> 06:00:43,075
DIFFERENT PERSON DOES REAL WORLD

8997
06:00:43,075 --> 06:00:46,045
STUDY, IF WE CAN HAVE GROUPS OF

8998
06:00:46,045 --> 06:00:47,580
PEOPLE, TEAMS OF INVESTIGATORS

8999
06:00:47,580 --> 06:00:49,749
WITH EXPERTISE IN ALL OF THESE

9000
06:00:49,749 --> 06:00:51,951
AREAS THAT CAN WORK TOGETHER AND

9001
06:00:51,951 --> 06:00:59,392
DESIGN THE PROCESS IN THIS WAY,

9002
06:00:59,392 --> 06:01:02,027
WE PROBABLY WILL BE MORE

9003
06:01:02,027 --> 06:01:02,294
EFFICIENT.

9004
06:01:02,294 --> 06:01:04,864
>> I'LL ADD THAT THIS IS
THIS

9005
06:01:04,864 --> 06:01:07,533
MAY BE SIMPLISTIC BUT IN TERMS

9006
06:01:07,533 --> 06:01:09,135
OF REGISTRIES, OF COURSE EUROPE

9007
06:01:09,135 --> 06:01:10,870
DOES A MUCH BETTER -- I'M NOT

9008
06:01:10,870 --> 06:01:13,072
GOING TO SAY BETTER BUT THEY DO

9009
06:01:13,072 --> 06:01:14,039
IT DIFFERENTLY, RIGHT?

9010
06:01:14,039 --> 06:01:16,475
SO THAT WOULD BE I THINK

9011
06:01:16,475 --> 06:01:20,846
INCREDIBLE TO HAVE A ROBUST

9012
06:01:20,846 --> 06:01:22,848
SYSTEM BECAUSE IT'S GOING TO

9013
06:01:22,848 --> 06:01:24,150
CONTINUE TO CHANGE INCREDIBLY

9014
06:01:24,150 --> 06:01:24,450
RAPIDLY.

9015
06:01:24,450 --> 06:01:27,219
JUST THE OTHER DAY I WAS, YOU

9016
06:01:27,219 --> 06:01:29,288
KNOW, SPEAKING WITH A COLLEAGUE,

9017
06:01:29,288 --> 06:01:32,358
AND WE WERE LIKE, CAN YOU

9018
06:01:32,358 --> 06:01:34,427
BELIEVE FIVE YEARS AGO, YOU

9019
06:01:34,427 --> 06:01:36,262
KNOW, AND I'VE BEEN DOING THIS

9020
06:01:36,262 --> 06:01:37,797
FOR ALMOST 20 YEARS, IT'S

9021
06:01:37,797 --> 06:01:42,501
AMAZING HOW IT'S GONE FROM

9022
06:01:42,501 --> 06:01:43,803
OBESITY NOT A DISEASE, CLEARLY A

9023
06:01:43,803 --> 06:01:46,672
DISEASE, TO WE HAVE THINGS THAT

9024
06:01:46,672 --> 06:01:50,176
CAN HAPPEN TO WOW WE HAVE THINGS

9025
06:01:50,176 --> 06:01:53,579
THAT IMPACT BIOLOGY.

9026
06:01:53,579 --> 06:01:55,314
WE'VE HAD BARIATRIC SURGERY BUT

9027
06:01:55,314 --> 06:01:56,315
NOT MEDICATIONS, IT'S CHANGING

9028
06:01:56,315 --> 06:01:57,616
SO RAPIDLY.

9029
06:01:57,616 --> 06:01:59,585
WE'RE IN OUR INFANCY.

9030
06:01:59,585 --> 06:02:03,389
SO IF IT'S CHANGING THIS RAPIDLY

9031
06:02:03,389 --> 06:02:05,257
NOW, I MEAN, MULTIPLY.

9032
06:02:05,257 --> 06:02:06,592
THERE'S HUNDREDS OF MEDICATIONS

9033
06:02:06,592 --> 06:02:07,993
IN DEVELOPMENT.

9034
06:02:07,993 --> 06:02:09,495
WE'RE ONLY TALKING ABOUT ONE

9035
06:02:09,495 --> 06:02:10,296
CLASS TODAY.

9036
06:02:10,296 --> 06:02:12,465
THERE ARE MULTIPLE OTHER CLASSES

9037
06:02:12,465 --> 06:02:16,101
THAT ARE BEING DEVELOPED.

9038
06:02:16,101 --> 06:02:18,404
SO, ANYWAY, IF THERE'S A WAY NOT

9039
06:02:18,404 --> 06:02:20,673
JUST TO CAPTURE MOMENTS IN TIME

9040
06:02:20,673 --> 06:02:23,075
WHICH IS WHAT WE DO WITH RCTs,

9041
06:02:23,075 --> 06:02:25,711
IF THERE'S A WAY TO CAPTURE

9042
06:02:25,711 --> 06:02:29,215
MOMENTS IN TIME AND CONTINUOUS

9043
06:02:29,215 --> 06:02:31,484
MOVING PICTURE, EVOLVING

9044
06:02:31,484 --> 06:02:35,588
PICTURE, THAT WOULD BE IDEAL.

9045
06:02:35,588 --> 06:02:37,356
>> I WOULD JUST UNDERSCORE

9046
06:02:37,356 --> 06:02:40,092
ACTUALLY BOTH OF THESE POINTS,

9047
06:02:40,092 --> 06:02:42,528
MIGUEL, THE POINT ABOUT

9048
06:02:42,528 --> 06:02:43,629
COORDINATED EFFORTS, RIGHT?

9049
06:02:43,629 --> 06:02:45,297
I'VE BEEN STRUCK OVER THE COURSE

9050
06:02:45,297 --> 06:02:47,700
OF THE ENTIRE DAY ABOUT THE

9051
06:02:47,700 --> 06:02:48,734
SHEER VOLUME OF QUESTIONS OF

9052
06:02:48,734 --> 06:02:54,807
GAPS THAT NEED TO BE FILLED.

9053
06:02:54,807 --> 06:02:57,977
AND THE WORST CASE SCENARIO,

9054
06:02:57,977 --> 06:03:01,814
EVERYONE TRIES TO DO THAT

9055
06:03:01,814 --> 06:03:02,147
INDIVIDUALLY.

9056
06:03:02,147 --> 06:03:04,049
MIGUEL MAKES AN IMPORTANT POINT,

9057
06:03:04,049 --> 06:03:05,117
LET'S BE COORDINATED THINKING

9058
06:03:05,117 --> 06:03:08,821
HOW TO DO REALLY IMPORTANT

9059
06:03:08,821 --> 06:03:10,689
LONG-TERM STUDIES.

9060
06:03:10,689 --> 06:03:12,658
ANIA, TO YOUR POINT, I AGREE

9061
06:03:12,658 --> 06:03:15,194
LIKE REGISTRIES HAVE TO BE A

9062
06:03:15,194 --> 06:03:16,295
COMPONENT OF THIS.

9063
06:03:16,295 --> 06:03:19,665
THERE'S, YOU KNOW, NO OTHER WAY,

9064
06:03:19,665 --> 06:03:20,733
I THINK.

9065
06:03:20,733 --> 06:03:25,571
>> SO THE NEXT FEW
QUESTIONS ARE

9066
06:03:25,571 --> 06:03:26,305
FOR SPECIFIC SPEAKERS.

9067
06:03:26,305 --> 06:03:27,973
IF YOU DON'T GET A QUESTION TAKE

9068
06:03:27,973 --> 06:03:31,043
A MENTAL BREAK FOR 30 SECONDS.

9069
06:03:31,043 --> 06:03:33,345
ANIA, YOU MENTIONED THAT

9070
06:03:33,345 --> 06:03:35,681
ADHERENCE IS THE SECRET WEAPON,

9071
06:03:35,681 --> 06:03:37,516
PATIENTS POP IN AND REGAIN

9072
06:03:37,516 --> 06:03:39,985
WEIGHT, MAYBE THEY WILL TAKE THE

9073
06:03:39,985 --> 06:03:43,856
DRUG AGAIN, SO YOU ARE IN THIS

9074
06:03:43,856 --> 06:03:44,857
CLINICAL SPACE.

9075
06:03:44,857 --> 06:03:49,361
AND DO YOU KNOW IF THERE'S ANY

9076
06:03:49,361 --> 06:03:53,065
MOVEMENT ON JUST DEVELOPING SORT

9077
06:03:53,065 --> 06:03:56,835
OF EVEN MORE EXTENDED RELEASE

9078
06:03:56,835 --> 06:03:59,138
REGIMENS, ASSUMING THAT PATIENT

9079
06:03:59,138 --> 06:04:00,873
TOLERATED WELL, MAYBE YOU'LL

9080
06:04:00,873 --> 06:04:04,043
HAVE INJECTION THAT EVERY SIX

9081
06:04:04,043 --> 06:04:05,811
MONTHS, I NOTICED THE FIELD

9082
06:04:05,811 --> 06:04:07,313
MOVING TO ORAL MEDICATION FOR

9083
06:04:07,313 --> 06:04:10,416
GOOD REASON BUT ON THE FLIP SIDE

9084
06:04:10,416 --> 06:04:13,586
IS THERE ANY DEVELOPMENT ON THE

9085
06:04:13,586 --> 06:04:15,554
FRONT JUST TO FURTHER IMPROVE

9086
06:04:15,554 --> 06:04:16,522
ADHERENCE, IF WILL YOU?

9087
06:04:16,522 --> 06:04:17,656
>> YES.

9088
06:04:17,656 --> 06:04:20,492
SO GREAT QUESTION.

9089
06:04:20,492 --> 06:04:22,227
AND THERE'S MULTIPLE APPROACHES

9090
06:04:22,227 --> 06:04:23,329
TO MAINTENANCE.

9091
06:04:23,329 --> 06:04:25,164
AND I DO FULLY BELIEVE THAT

9092
06:04:25,164 --> 06:04:27,333
ADHERENCE IS GOING TO BE THE

9093
06:04:27,333 --> 06:04:29,568
SECRET WEAPON.

9094
06:04:29,568 --> 06:04:31,737
WHAT I DO CLINICALLY, I GIVE

9095
06:04:31,737 --> 06:04:33,639
PATIENTS, IF THEY WANT TO STOP,

9096
06:04:33,639 --> 06:04:34,974
I SAY LET'S DECREASE THE DOSE

9097
06:04:34,974 --> 06:04:36,709
AND SEE WHAT HAPPENS.

9098
06:04:36,709 --> 06:04:38,110
IF WE DECREASE THE DOSE AND

9099
06:04:38,110 --> 06:04:40,312
THEIR WEIGHT IS STABLE WE CAN

9100
06:04:40,312 --> 06:04:41,213
DECREASE AGAIN.

9101
06:04:41,213 --> 06:04:43,515
MOST OFTEN WHAT HAPPENS IS THAT

9102
06:04:43,515 --> 06:04:45,050
WE END UP INCREASING DOSE BACK

9103
06:04:45,050 --> 06:04:48,320
UP BECAUSE THEY ARE REGAINING

9104
06:04:48,320 --> 06:04:49,521
WEIGHT OR STRUGGLING.

9105
06:04:49,521 --> 06:04:50,823
SOMETIMES WE CAN DECREASE THE

9106
06:04:50,823 --> 06:04:53,125
DOSE FOR SOME TIME OR SPACE OUT

9107
06:04:53,125 --> 06:04:54,893
THE DOSE, SO PATIENTS DON'T TAKE

9108
06:04:54,893 --> 06:04:57,630
IT ONCE WEEKLY BUT MAYBE EVERY

9109
06:04:57,630 --> 06:04:58,764
OTHER WEEK AND THEN AFTER A YEAR

9110
06:04:58,764 --> 06:05:00,633
AND A HALF OR SO THEY INCREASE

9111
06:05:00,633 --> 06:05:01,700
BACK UP.

9112
06:05:01,700 --> 06:05:02,835
SO IT JUST DEPENDS ON THE

9113
06:05:02,835 --> 06:05:03,302
PATIENT.

9114
06:05:03,302 --> 06:05:04,470
WE DON'T HAVE ENOUGH

9115
06:05:04,470 --> 06:05:04,770
INFORMATION.

9116
06:05:04,770 --> 06:05:06,438
TO YOUR POINT IN TERMS OF

9117
06:05:06,438 --> 06:05:08,307
SPACING OUT THE DOSE FOR

9118
06:05:08,307 --> 06:05:09,408
MAINTENANCE, NOT JUST EVEN

9119
06:05:09,408 --> 06:05:10,542
SPACING OUT THE DOSE BUT

9120
06:05:10,542 --> 06:05:12,311
OPPORTUNITIES FOR THINGS THAT

9121
06:05:12,311 --> 06:05:14,213
ARE LESS FREQUENT THERE ARE A

9122
06:05:14,213 --> 06:05:16,849
FEW AGENTS IN DEVELOPMENT THAT

9123
06:05:16,849 --> 06:05:23,188
ARE MONTHLY, AND THERE'S ONE

9124
06:05:23,188 --> 06:05:29,428
CALLED MARITIDE, MONTHLY OR LESS

9125
06:05:29,428 --> 06:05:31,997
FREQUENT, WE'LL HAVE TO SAY

9126
06:05:31,997 --> 06:05:32,665
WHETHER THOSE MEDICATIONS, THAT

9127
06:05:32,665 --> 06:05:35,934
ONE AND ANY OF THE OTHERS IN

9128
06:05:35,934 --> 06:05:37,136
DEVELOPMENT, CAN ACTUALLY BE

9129
06:05:37,136 --> 06:05:38,537
TAKEN EVEN LESS FREQUENTLY THAN

9130
06:05:38,537 --> 06:05:40,539
WHEN ONCE A MONTH BUT IMAGINE

9131
06:05:40,539 --> 06:05:42,908
TAKING SOMETHING ONCE A MONTH,

9132
06:05:42,908 --> 06:05:46,979
SO 12 TIMES OR LESS A YEAR AND

9133
06:05:46,979 --> 06:05:47,946
TREATING OBESITY.

9134
06:05:47,946 --> 06:05:50,582
SO I THINK LOTS TO LOOK TOWARDS

9135
06:05:50,582 --> 06:05:53,752
AND THEN AS YOU MENTIONED, DAILY

9136
06:05:53,752 --> 06:05:59,491
ORAL MEDICATIONS COMING AS WELL.

9137
06:05:59,491 --> 06:06:02,327
AND ORAL SEMAGLUTIDE HIGHER DOSE

9138
06:06:02,327 --> 06:06:04,530
HAS BEEN INVESTIGATED, AND

9139
06:06:04,530 --> 06:06:05,698
LOOKED AT, AS POTENTIAL

9140
06:06:05,698 --> 06:06:10,069
TREATMENT FOR OBESITY SO WE'LL

9141
06:06:10,069 --> 06:06:12,404
AWAIT FDA EVALUATION AND THEN

9142
06:06:12,404 --> 06:06:16,208
THE NEXT ONE, A SMALL MOLECULE

9143
06:06:16,208 --> 06:06:16,542
ORAL DAILY.

9144
06:06:16,542 --> 06:06:20,579
AGAIN, THERE'S SO MUCH TO

9145
06:06:20,579 --> 06:06:21,013
ANTICIPATE.

9146
06:06:21,013 --> 06:06:23,015
THERE'S MANY ORAL -- DAILY ORALS

9147
06:06:23,015 --> 06:06:24,616
IN DEVELOPMENT AS WELL.

9148
06:06:24,616 --> 06:06:27,352
>> YES, ABSOLUTELY.

9149
06:06:27,352 --> 06:06:33,492
SO INSTEAD OF TEN PAPERS A DAY,

9150
06:06:33,492 --> 06:06:33,625
--

9151
06:06:33,625 --> 06:06:34,893
>> YES, EXACTLY.

9152
06:06:34,893 --> 06:06:38,630
NEXT QUESTION FOR MIGUEL.

9153
06:06:38,630 --> 06:06:46,238
TALKING ABOUT THE FEASIBILITY OF

9154
06:06:46,238 --> 06:06:48,407
STUDYING OFF-LABEL USE, SO

9155
06:06:48,407 --> 06:06:50,242
THERE'S A QUESTION ABOUT HOW DO

9156
06:06:50,242 --> 06:06:53,545
YOU ACTUALLY ASSEMBLE THE STUDY

9157
06:06:53,545 --> 06:06:54,413
POPULATION?

9158
06:06:54,413 --> 06:06:57,683
SO HAVE YOU USED TARGET TRIAL

9159
06:06:57,683 --> 06:07:01,754
EMULATION FRAMEWORK FOR

9160
06:07:01,754 --> 06:07:02,988
OFF-LABEL MEDICATION, NOT

9161
06:07:02,988 --> 06:07:04,857
NECESSARILY GLP-1 THERAPIES.

9162
06:07:04,857 --> 06:07:06,925
>> THAT IS ONE OF THE MAIN

9163
06:07:06,925 --> 06:07:07,893
ADVANTAGES, HAVING OBSERVATIONAL

9164
06:07:07,893 --> 06:07:12,164
DATA THAT YOU CAN DO THAT TYPE

9165
06:07:12,164 --> 06:07:12,798
OF THINGS.

9166
06:07:12,798 --> 06:07:14,867
MANY TIMES WHEN THE OUTCOME IS

9167
06:07:14,867 --> 06:07:20,139
NOT THE OUTCOME FOR WHICH THE

9168
06:07:20,139 --> 06:07:21,673
TREATMENT IS INDICATED,

9169
06:07:21,673 --> 06:07:22,975
CONFOUNDING, MAGNITUDE OF CON

9170
06:07:22,975 --> 06:07:24,076
FOUNDER IS SMALLER.

9171
06:07:24,076 --> 06:07:26,044
YES, WE DO THIS ALL THE TIME.

9172
06:07:26,044 --> 06:07:36,588
FOR EXAMPLE, WE'RE KNOW LOOKING

9173
06:07:37,689 --> 06:07:39,925
AT STARTING THERAPIES, NOT WHAT

9174
06:07:39,925 --> 06:07:42,661
IT IS INDICATED FOR.

9175
06:07:42,661 --> 06:07:44,897
WE'RE WORKING WITH THE

9176
06:07:44,897 --> 06:07:48,133
INVESTIGATORS TO TRY TO DO THE

9177
06:07:48,133 --> 06:07:52,504
COORDINATED EFFORT THAT LESLEY

9178
06:07:52,504 --> 06:07:54,239
WAS MENTIONING, AND FOR GLP-1

9179
06:07:54,239 --> 06:07:56,642
THERAPIES OF COURSE WE CAN LOOK

9180
06:07:56,642 --> 06:07:59,044
AT OUTCOMES THAT WERE NOT THE

9181
06:07:59,044 --> 06:08:01,046
OUTCOMES FOR WHICH THIS WAS

9182
06:08:01,046 --> 06:08:03,015
INDICATED, MANY PEOPLE ARE DOING

9183
06:08:03,015 --> 06:08:04,416
NOW.

9184
06:08:04,416 --> 06:08:06,185
YES, THIS IS ONE OF THE MAIN

9185
06:08:06,185 --> 06:08:08,253
USES OF THE REAL WORLD DATA.

9186
06:08:08,253 --> 06:08:14,059
THIS CAN BE THE FOUNDATION FOR

9187
06:08:14,059 --> 06:08:16,728
RANDOMIZED TRIALS LATER.

9188
06:08:16,728 --> 06:08:20,465
>> SO, THIS QUESTION FOR
LESLEY.

9189
06:08:20,465 --> 06:08:25,237
WE SPOKE EARLIER ABOUT MEDICARE

9190
06:08:25,237 --> 06:08:26,572
NOT CURRENTLY COVERING THESE

9191
06:08:26,572 --> 06:08:28,440
DRUGS FOR OBESITY OR CHRONIC

9192
06:08:28,440 --> 06:08:29,374
WEIGHT MANAGEMENT.

9193
06:08:29,374 --> 06:08:32,044
IN THAT CASE IF WE STILL WANT TO

9194
06:08:32,044 --> 06:08:36,014
STUDY EFFECT OF THIS DRUG IN THE

9195
06:08:36,014 --> 06:08:38,383
ELDERLY POPULATION, HOW DO WE

9196
06:08:38,383 --> 06:08:42,921
USE REAL WORLD DATA TO

9197
06:08:42,921 --> 06:08:43,989
ACCOMPLISH THAT?

9198
06:08:43,989 --> 06:08:48,193
>>  SO, IF I HAD LIKE A
MAGIC

9199
06:08:48,193 --> 06:08:49,962
WISH WAND, MY MAGIC WAND WOULD

9200
06:08:49,962 --> 06:08:52,998
SAY LET'S USE COVERAGE WITH

9201
06:08:52,998 --> 06:08:54,666
EVIDENCE DEVELOPMENT, RIGHT?

9202
06:08:54,666 --> 06:08:56,835
WHERE AS WE MAKE THE DRUG

9203
06:08:56,835 --> 06:09:00,105
AVAILABLE FOR THE PURPOSES OF

9204
06:09:00,105 --> 06:09:01,874
STUDYING, THESE DRUGS AVAILABLE

9205
06:09:01,874 --> 06:09:06,245
FOR PURPOSES OF STUDYING,

9206
06:09:06,245 --> 06:09:08,547
QUANTIFYING THE EFFECT, AND

9207
06:09:08,547 --> 06:09:10,048
ANSWER THE IMPORTANT QUESTIONS

9208
06:09:10,048 --> 06:09:15,087
SO WE CAN BEGIN TO ACTUALLY

9209
06:09:15,087 --> 06:09:18,924
DEMONSTRATE OR EVALUATE NOT JUST

9210
06:09:18,924 --> 06:09:22,094
EFFECTIVENESS IN THAT

9211
06:09:22,094 --> 06:09:26,365
POPULATION, TO BEGIN TO LOOK AT

9212
06:09:26,365 --> 06:09:27,566
COST EFFECTIVENESS, A REAL

9213
06:09:27,566 --> 06:09:28,333
DRIVER.

9214
06:09:28,333 --> 06:09:29,334
CLEARLY THAT'S NOT A

9215
06:09:29,334 --> 06:09:30,335
CONSIDERATION FOR MEDICATION BUT

9216
06:09:30,335 --> 06:09:33,372
IT'S A CONSIDERATION FOR OTHER

9217
06:09:33,372 --> 06:09:35,240
PAYERS WHO WOULD LOOK TO

9218
06:09:35,240 --> 06:09:36,541
MEDICARE RESULTS, OR WOULD LOOK

9219
06:09:36,541 --> 06:09:41,380
TO THAT STUDY TO INFORM THEIR

9220
06:09:41,380 --> 06:09:42,247
DECISIONS.

9221
06:09:42,247 --> 06:09:43,215
>> A FEW MINUTES LEFT.

9222
06:09:43,215 --> 06:09:46,318
THIS IS OUR LAST QUESTION.

9223
06:09:46,318 --> 06:09:51,890
FOR ALL THE SPEAKERS. 

9224
06:09:51,890 --> 06:09:54,293
WE SPOKE ABOUT -- MIGUEL SAID

9225
06:09:54,293 --> 06:09:57,362
OBSERVATIONAL STUDIES AND TRIALS

9226
06:09:57,362 --> 06:10:00,132
ARE COMPLEMENTARY.

9227
06:10:00,132 --> 06:10:01,533
ANIA MENTIONED REGISTRY DATA

9228
06:10:01,533 --> 06:10:03,835
FROM OTHER COUNTRIES.

9229
06:10:03,835 --> 06:10:05,671
LESLEY NICELY SAID, WELL, MAYBE

9230
06:10:05,671 --> 06:10:07,339
THERE'S SOMETHING THERE.

9231
06:10:07,339 --> 06:10:08,974
SO JUST INTERESTED IN YOUR

9232
06:10:08,974 --> 06:10:10,709
THOUGHT ABOUT HOW TO MAKE THAT

9233
06:10:10,709 --> 06:10:11,176
HAPPEN.

9234
06:10:11,176 --> 06:10:17,916
HOW DO WE HAVE A MORE ROBUST

9235
06:10:17,916 --> 06:10:20,686
EVIDENCE GENERATION PLATFORM TO

9236
06:10:20,686 --> 06:10:21,853
STUDY GLP-1 THERAPIES?

9237
06:10:21,853 --> 06:10:25,624
>>  I'M GLAD YOU ENDED
WITH AN

9238
06:10:25,624 --> 06:10:26,925
EASY QUESTION.

9239
06:10:26,925 --> 06:10:31,630
YOU KNOW, LET ME THROW OUT

9240
06:10:31,630 --> 06:10:34,366
OPTIMISM, AT THE END OF A DAY OF

9241
06:10:34,366 --> 06:10:36,134
A MEETING.

9242
06:10:36,134 --> 06:10:39,838
I DO THINK THAT AS WE LOOK AT

9243
06:10:39,838 --> 06:10:42,908
WHAT HAS HAPPENED, WHAT IS

9244
06:10:42,908 --> 06:10:44,343
HAPPENING IN TERMS OF ELECTRONIC

9245
06:10:44,343 --> 06:10:47,312
HEALTH RECORD DATA AND SOME

9246
06:10:47,312 --> 06:10:48,613
STANDARDIZATION EFFORTS, RIGHT?

9247
06:10:48,613 --> 06:10:55,721
THERE ARE TOOLS, WHETHER FHIR,

9248
06:10:55,721 --> 06:10:57,022
USCDI, STANDARDIZED PUMPS TO

9249
06:10:57,022 --> 06:10:59,825
MOVE DATA AROUND, I FEEL LIKE

9250
06:10:59,825 --> 06:11:00,692
WE'RE POTENTIALLY APPROACHING A

9251
06:11:00,692 --> 06:11:03,195
POINT WHERE THE KINDS OF DATA

9252
06:11:03,195 --> 06:11:07,032
THAT WE NEED TO ANSWER THESE

9253
06:11:07,032 --> 06:11:09,901
QUESTIONS ARE EXISTING AND COULD

9254
06:11:09,901 --> 06:11:11,970
BE PUT TOGETHER FOR THIS.

9255
06:11:11,970 --> 06:11:15,040
I WOULD LOVE TO THINK ABOUT

9256
06:11:15,040 --> 06:11:16,575
POTENTIALLY, YOU KNOW, THESE

9257
06:11:16,575 --> 06:11:19,211
QUESTIONS AS A DRIVING USE CASE

9258
06:11:19,211 --> 06:11:21,747
FOR HOW WE MIGHT DEVELOP SUCH A

9259
06:11:21,747 --> 06:11:22,614
PLATFORM, RIGHT?

9260
06:11:22,614 --> 06:11:24,249
SO WE COULD DO THE WORK THAT

9261
06:11:24,249 --> 06:11:26,451
WE'VE BEEN TALKING ABOUT ALL

9262
06:11:26,451 --> 06:11:28,420
DAY.

9263
06:11:28,420 --> 06:11:33,125
SO THERE'S MY OPTIMISTIC

9264
06:11:33,125 --> 06:11:34,026
RESPONSE.

9265
06:11:34,026 --> 06:11:36,928
>> LET ME ADD TO THAT
OPTIMISM

9266
06:11:36,928 --> 06:11:37,462
TOO.

9267
06:11:37,462 --> 06:11:41,199
I THINK THAT WE ARE SEEING AN

9268
06:11:41,199 --> 06:11:43,835
INCREASING NUMBER OF EXAMPLES

9269
06:11:43,835 --> 06:11:47,639
AROUND THE WORLD HOW TO DO THIS,

9270
06:11:47,639 --> 06:11:49,641
IN PRINCIPLE THERE'S A REASON

9271
06:11:49,641 --> 06:11:50,609
WHY IT'S GOING TO HAPPEN IN THE

9272
06:11:50,609 --> 06:11:52,310
U.S. TOO.

9273
06:11:52,310 --> 06:11:56,882
IF YOU THINK FOR EXAMPLE DURING

9274
06:11:56,882 --> 06:11:58,517
THE PANDEMIC THE U.K. GAVE US A

9275
06:11:58,517 --> 06:12:03,422
LESSON HOW YOU CAN DO TRIALS

9276
06:12:03,422 --> 06:12:05,757
WITH LOTS OF PEOPLE, PRECISE

9277
06:12:05,757 --> 06:12:06,825
ESTIMATES LINKED TO ELECTRONIC

9278
06:12:06,825 --> 06:12:07,893
HEALTH RECORDS.

9279
06:12:07,893 --> 06:12:12,097
SO THAT'S ONE WAY IN WHICH YOU

9280
06:12:12,097 --> 06:12:13,398
CAN COMBINE BOTH SOURCES OF

9281
06:12:13,398 --> 06:12:13,832
INFORMATION.

9282
06:12:13,832 --> 06:12:16,568
WE HAVE PROJECTS IN SWEDEN IN

9283
06:12:16,568 --> 06:12:23,675
WHICH THEY ARE NATIONAL REG 

9284
06:12:23,675 --> 06:12:25,310
REGISTRIES USED AS SOURCE FOR

9285
06:12:25,310 --> 06:12:26,311
TRIALS, WHICH MEANS YOU HAVE THE

9286
06:12:26,311 --> 06:12:27,813
REAL WORLD DATA AND TRIAL DATA

9287
06:12:27,813 --> 06:12:30,882
COMING FROM THE SAME PEOPLE.

9288
06:12:30,882 --> 06:12:34,052
AND YOU CAN DO BENCHMARKING,

9289
06:12:34,052 --> 06:12:35,353
SOMETIMES WE'VE DONE IT, DONE

9290
06:12:35,353 --> 06:12:36,688
THE BENCHMARKING OF TRIALS THAT

9291
06:12:36,688 --> 06:12:42,160
HAVEN'T BEEN FINISHED YET SO WE

9292
06:12:42,160 --> 06:12:43,595
CAN EXTEND THE RESULTS AFTER

9293
06:12:43,595 --> 06:12:44,496
THEY ARE FINISHED.

9294
06:12:44,496 --> 06:12:48,300
HERE IN THE U.S. THERE ARE A FEW

9295
06:12:48,300 --> 06:12:50,035
EXAMPLES, MOST PROMINENT MAY BE

9296
06:12:50,035 --> 06:12:54,106
THE V.A., THE LARGEST HEALTH

9297
06:12:54,106 --> 06:13:00,011
CARE SYSTEM IN THE COUNTRY.

9298
06:13:00,011 --> 06:13:02,881
VERY RICH DATA, INFRASTRUCTURE

9299
06:13:02,881 --> 06:13:04,282
ON THOUSANDS EVER INVESTIGATORS

9300
06:13:04,282 --> 06:13:09,321
THAT CAN ACCESS THE DATA BUT ARE

9301
06:13:09,321 --> 06:13:10,889
A SOURCE OF RANDOMIZED TRIALS,

9302
06:13:10,889 --> 06:13:14,726
DONE WITHIN THE HEALTH SYSTEM.

9303
06:13:14,726 --> 06:13:16,528
ONCE YOU HAVE THE SETTING,

9304
06:13:16,528 --> 06:13:18,630
TRIALS ARE DONE AS PART OF --

9305
06:13:18,630 --> 06:13:20,065
WITHIN THE HEALTH SYSTEM AND YOU

9306
06:13:20,065 --> 06:13:21,733
HAVE THE REAL WORLD DATA, COMING

9307
06:13:21,733 --> 06:13:26,338
FROM THE SAME PEOPLE WITH THE

9308
06:13:26,338 --> 06:13:27,873
SAME QUALITY, A LOT OF

9309
06:13:27,873 --> 06:13:30,775
OPPORTUNITIES OPEN, STARTING TO

9310
06:13:30,775 --> 06:13:36,982
HAPPEN, I HOPE TO SEE MUCH MORE

9311
06:13:36,982 --> 06:13:40,152
OF IT.

9312
06:13:40,152 --> 06:13:42,888
>> I'M ALSO AN OPTIMIST.

9313
06:13:42,888 --> 06:13:48,393
I'LL ADD OBESITY AFFECTS A

9314
06:13:48,393 --> 06:13:50,262
BILLION PEOPLE.

9315
06:13:50,262 --> 06:13:52,564
IN THOSE BILLION PEOPLE, OBESITY

9316
06:13:52,564 --> 06:13:54,833
IS RELATED OR CONTRIBUTES TO OR

9317
06:13:54,833 --> 06:13:57,402
PRIMARY CAUSE OF HUNDREDS OF

9318
06:13:57,402 --> 06:13:59,671
OTHER DISEASES, OVER 200.

9319
06:13:59,671 --> 06:14:02,641
AND SO NOT ONLY IS THIS AN

9320
06:14:02,641 --> 06:14:03,742
AMAZING OPPORTUNITY BUT IT'S

9321
06:14:03,742 --> 06:14:05,343
SOMETHING THAT I THINK HAS TO BE

9322
06:14:05,343 --> 06:14:09,648
DONE, SO MAYBE THIS IS THE

9323
06:14:09,648 --> 06:14:10,615
IMPETUS TO DO IT.

9324
06:14:10,615 --> 06:14:12,584
GIVEN SO MANY PEOPLE ARE

9325
06:14:12,584 --> 06:14:13,451
AFFECTED, WE CAN TRANSFORM

9326
06:14:13,451 --> 06:14:15,587
HEALTH IF WE CAN UNDERSTAND HOW

9327
06:14:15,587 --> 06:14:22,027
BEST TO TREAT THIS ONE DISEASE.

9328
06:14:22,027 --> 06:14:22,327
>> GREAT.

9329
06:14:22,327 --> 06:14:25,530
THERE'S A GOOD END TO OUR

9330
06:14:25,530 --> 06:14:26,097
FANTASTIC DISCUSSION.

9331
06:14:26,097 --> 06:14:29,701
THANK YOU ALL FOR THE VERY

9332
06:14:29,701 --> 06:14:30,302
EXCELLENT PRESENTATIONS.

9333
06:14:30,302 --> 06:14:33,205
I LEARNED A LOT FROM YOUR

9334
06:14:33,205 --> 06:14:34,172
PRESENTATIONS TODAY.

9335
06:14:34,172 --> 06:14:36,474
WITH THAT WE'RE READY TO MOVE TO

9336
06:14:36,474 --> 06:14:38,009
THE NEXT SESSION.

9337
06:14:38,009 --> 06:14:47,185
THAT'S FOR THE CO-CHAIRS.

9338
06:14:47,185 --> 06:14:49,721
THANK YOU.

9339
06:14:49,721 --> 06:14:50,589
>> FANTASTIC SESSION.

9340
06:14:50,589 --> 06:14:52,357
JUST REALLY IN AWE OF ALL THE

9341
06:14:52,357 --> 06:14:53,892
PRESENTERS TODAY.

9342
06:14:53,892 --> 06:14:55,961
IT'S BEEN A SPECTACULAR DAY.

9343
06:14:55,961 --> 06:14:57,495
I'VE LEARNED SO MUCH, REALLY

9344
06:14:57,495 --> 06:14:59,264
FEEL INSPIRED BY THE QUESTIONS

9345
06:14:59,264 --> 06:15:01,666
BEING ASKED AND ENGAGEMENT FROM

9346
06:15:01,666 --> 06:15:02,601
EVERYONE ATTENDING.

9347
06:15:02,601 --> 06:15:05,370
WE WANTED TO TRY TO SPEND A

9348
06:15:05,370 --> 06:15:06,905
LITTLE TIME SUMMING UP WHAT

9349
06:15:06,905 --> 06:15:09,107
WE'VE HEARD ABOUT MAJOR GAPS AND

9350
06:15:09,107 --> 06:15:09,674
OPPORTUNITIES.

9351
06:15:09,674 --> 06:15:11,276
I DID PULL TOGETHER SLIDES TO

9352
06:15:11,276 --> 06:15:12,611
TRY TO HELP KICK US OFF.

9353
06:15:12,611 --> 06:15:22,454
I WANT TO PUT A CHALLENGE OUT TO

9354
06:15:22,454 --> 06:15:25,190
THE ATTENDEES TO ENGAGE IN A

9355
06:15:25,190 --> 06:15:27,125
CONVERSATION ABOUT YOUR MAJOR

9356
06:15:27,125 --> 06:15:29,794
TAKEHOMES FROM TODAY SO FAR.

9357
06:15:29,794 --> 06:15:35,233
AND SORT OF I LIKE WHERE WE WERE

9358
06:15:35,233 --> 06:15:36,568
ENDING AROUND OUT-OF-THE-BOX

9359
06:15:36,568 --> 06:15:38,637
THINKING ABOUT WHAT'S IT GOING

9360
06:15:38,637 --> 06:15:40,839
TO TAKE TO MOVE THE FIELD

9361
06:15:40,839 --> 06:15:43,008
FORWARD RAPIDLY, CHANGES IN HOW

9362
06:15:43,008 --> 06:15:44,743
WE'RE AGGREGATING DATA OR

9363
06:15:44,743 --> 06:15:47,245
THINKING BOLDLY ABOUT HOW WE

9364
06:15:47,245 --> 06:15:55,153
USES GLP-1s IN USE CASE AROUND

9365
06:15:55,153 --> 06:15:56,354
DATA ACCESS, LONGITUDINAL, ET

9366
06:15:56,354 --> 06:16:00,392
CETERA, KICKING THAT OFF. 

9367
06:16:00,392 --> 06:16:03,828
I WILL SHARE MY SCREEN AND BRING

9368
06:16:03,828 --> 06:16:11,903
UP SLIDES TO LOOK AT. 

9369
06:16:11,903 --> 06:16:13,538
SO, WE KICKED OFF THE DAY BY

9370
06:16:13,538 --> 06:16:16,408
TALKING ABOUT THE GAPS IN OUR

9371
06:16:16,408 --> 06:16:17,709
KNOWLEDGE THAT WE NEEDED TO

9372
06:16:17,709 --> 06:16:17,942
ADDRESS.

9373
06:16:17,942 --> 06:16:22,947
AND THAT WAS THE MAIN FOCUS OF

9374
06:16:22,947 --> 06:16:25,784
THE CONFERENCE TODAY.

9375
06:16:25,784 --> 06:16:28,219
OUR GOAL IS TO IDENTIFY GAPS AND

9376
06:16:28,219 --> 06:16:30,055
OPPORTUNITIES ON REAL WORLD

9377
06:16:30,055 --> 06:16:32,290
EVIDENCE FOR CLINICAL DECISION

9378
06:16:32,290 --> 06:16:34,225
MAKING AND GUIDELINE

9379
06:16:34,225 --> 06:16:36,628
DEVELOPMENT, WE HEARD AROUND

9380
06:16:36,628 --> 06:16:38,396
REGULATORY HEALTH CARE DECISION

9381
06:16:38,396 --> 06:16:42,000
MAKING, BEST PRACTICES FOR STUDY

9382
06:16:42,000 --> 06:16:44,269
DESIGNS, LAST SESSION WAS GREAT

9383
06:16:44,269 --> 06:16:45,937
FOR THAT, AND THE SESSION

9384
06:16:45,937 --> 06:16:48,139
EARLIER THIS MORNING AS WELL AS

9385
06:16:48,139 --> 06:16:49,341
ANALYTIC METHODS TO ADDRESS

9386
06:16:49,341 --> 06:16:50,842
SPECIFIC ISSUES, WE HEARD SOME

9387
06:16:50,842 --> 06:16:51,409
ABOUT THAT TODAY.

9388
06:16:51,409 --> 06:16:55,347
WE'LL HEAR MORE ABOUT THAT

9389
06:16:55,347 --> 06:16:56,514
TOMORROW.

9390
06:16:56,514 --> 06:16:58,316
I WANTED TO SUM UP KEY IDEAS

9391
06:16:58,316 --> 06:17:04,656
THAT I HEARD FROM EACH OF THE

9392
06:17:04,656 --> 06:17:05,123
SESSIONS

9393
06:17:05,123 --> 06:17:08,226
WHAT I WAS STRUCK BY IS THE

9394
06:17:08,226 --> 06:17:10,562
SMALL MOLECULES AND THEY ARE

9395
06:17:10,562 --> 06:17:12,831
EMERGING, MANY MORE OF THEM,

9396
06:17:12,831 --> 06:17:14,999
INTERESTING TO SEE CAN WE

9397
06:17:14,999 --> 06:17:17,302
OBSERVE REAL WORLD EFFICACY IS

9398
06:17:17,302 --> 06:17:19,270
COMPARABLE WITH SMALL MOLECULES

9399
06:17:19,270 --> 06:17:21,473
COMPARED TO INJECTABLES.

9400
06:17:21,473 --> 06:17:22,874
I WAS INTERESTED IN THE

9401
06:17:22,874 --> 06:17:25,310
STATEMENT ABOUT HEALTH BENEFITS

9402
06:17:25,310 --> 06:17:27,379
OF GLP-1s, SEEM TO REQUIRE

9403
06:17:27,379 --> 06:17:29,147
CONTINUOUS LONG-TERM TREATMENT.

9404
06:17:29,147 --> 06:17:30,448
SO ARE THERE ALTERNATIVE

9405
06:17:30,448 --> 06:17:33,284
TREATMENT PROTOCOLS THAT CAN

9406
06:17:33,284 --> 06:17:34,152
HELP SOME LONG-TERM MAINTENANCE?

9407
06:17:34,152 --> 06:17:37,789
IS IT OPEN TO ONGOING QUESTIONS?

9408
06:17:37,789 --> 06:17:40,291
AND MANY PEOPLE SPOKE ABOUT

9409
06:17:40,291 --> 06:17:41,960
ADHERENCE ISSUES.

9410
06:17:41,960 --> 06:17:44,796
ADHERENCE AS DAVE DESCRIBED IN

9411
06:17:44,796 --> 06:17:46,865
REAL WORLD DATA, DESPITE

9412
06:17:46,865 --> 06:17:48,133
TREATMENT EFFECTS, WE DO NEED TO

9413
06:17:48,133 --> 06:17:50,802
UNDERSTAND WHY AND IS IT DRIVEN

9414
06:17:50,802 --> 06:17:53,204
MOSTLY BY ACCESS AND

9415
06:17:53,204 --> 06:17:54,739
AFFORDABILITY OR OTHER ISSUES AT

9416
06:17:54,739 --> 06:17:55,073
PLAY?

9417
06:17:55,073 --> 06:17:58,343
I WAS STRUCK BY DAVE'S LAST

9418
06:17:58,343 --> 06:17:59,344
SLIDE WHICH PROPOSED CLINICAL

9419
06:17:59,344 --> 06:18:04,616
PRIORITIES FOR HOW WE THINK

9420
06:18:04,616 --> 06:18:07,585
ABOUT USING GLP-1s WITH TYPE 2

9421
06:18:07,585 --> 06:18:08,686
DIABETES FIRST, TARGETING

9422
06:18:08,686 --> 06:18:11,222
POPULATIONS FOR WEIGHT LOSS, WHO

9423
06:18:11,222 --> 06:18:12,957
HAVE CHRONIC DISEASE SUCH AS

9424
06:18:12,957 --> 06:18:18,229
CARDIOVASCULAR DISEASE, SLEEP

9425
06:18:18,229 --> 06:18:20,498
APNEA, BROAD PATIENT POPULATION

9426
06:18:20,498 --> 06:18:23,001
SUCH AS OBESITY WITHOUT CHRONIC

9427
06:18:23,001 --> 06:18:24,669
CONDITIONS, AND POPULATION

9428
06:18:24,669 --> 06:18:25,303
PREVENTIVE HEALTH.

9429
06:18:25,303 --> 06:18:29,140
WONDERING IF THIS IS THE RIGHT

9430
06:18:29,140 --> 06:18:30,575
SELECTION, DOES SEEMS TO BE HOW

9431
06:18:30,575 --> 06:18:31,443
MEDICARE IS OPERATING BUT IS

9432
06:18:31,443 --> 06:18:32,911
THAT THE RIGHT WAY TO MOVE

9433
06:18:32,911 --> 06:18:38,149
FORWARD AND SHOULD WE HAVE MORE

9434
06:18:38,149 --> 06:18:39,150
DEBATE WHAT CLINICAL PRIORITIES

9435
06:18:39,150 --> 06:18:45,924
SHOULD BE AND IS THERE RESEARCH.

9436
06:18:45,924 --> 06:18:50,762
AND COMMENTS WHETHER OR NOT

9437
06:18:50,762 --> 06:18:53,832
BENEFITS FROM CLINICAL TRIALS

9438
06:18:53,832 --> 06:18:54,232
TRANSLATE.

9439
06:18:54,232 --> 06:18:56,134
WE'LL WORLD EVIDENCE CAN INFORM

9440
06:18:56,134 --> 06:18:57,101
THAT GAP.

9441
06:18:57,101 --> 06:19:00,972
AND I WAS STRUCK BY THE

9442
06:19:00,972 --> 06:19:02,907
STATEMENT WE NEED TO FULL

9443
06:19:02,907 --> 06:19:04,676
SPECTRUM OF STUDY DESIGN TALKING

9444
06:19:04,676 --> 06:19:07,512
ABOUT TRADEOFFS OF REAL WORLD

9445
06:19:07,512 --> 06:19:09,347
STUDY DESIGN AND THERE'S

9446
06:19:09,347 --> 06:19:12,217
TRADEOFFS FOR EACH, IT'S HAVING

9447
06:19:12,217 --> 06:19:16,821
THIS COLLECTION OF THEM AND

9448
06:19:16,821 --> 06:19:17,522
MULTI-DISCIPLINARY EVIDENCE

9449
06:19:17,522 --> 06:19:18,456
GENERATION PROCESS THAT LEADS US

9450
06:19:18,456 --> 06:19:23,928
IN THE DIRECTION OF HAVING

9451
06:19:23,928 --> 06:19:25,230
BETTER KNOWLEDGE OVER TIME, SO

9452
06:19:25,230 --> 06:19:26,764
THERE WON'T BE SOME SUPERIORITY

9453
06:19:26,764 --> 06:19:27,966
OF OTHER STUDIES OVER SOME

9454
06:19:27,966 --> 06:19:32,103
OTHERS BUT I THINK WE NEED MANY

9455
06:19:32,103 --> 06:19:34,305
STUDIES AND DATABASES TO

9456
06:19:34,305 --> 06:19:35,840
TRIANGULATE THE TRUTH.

9457
06:19:35,840 --> 06:19:39,110
AND MATT POINTED TO ALSO THE

9458
06:19:39,110 --> 06:19:43,848
OUTCOMES OF PATIENT EXPERIENCE

9459
06:19:43,848 --> 06:19:45,049
AFTER DISCONTINUATION WITHOUT

9460
06:19:45,049 --> 06:19:45,917
RESTART, UNDERSTANDING WHEN

9461
06:19:45,917 --> 06:19:56,361
PATIENT STOPS WHAT ARE LONG-TERM

9462
06:19:56,361 --> 06:19:56,628
OUTCOMES?

9463
06:19:56,628 --> 06:20:02,367
NEXT SESSIONS, SESSION 1, DR.

9464
06:20:02,367 --> 06:20:05,904
BRADLEY, I WAS STRUCK BY THE

9465
06:20:05,904 --> 06:20:09,507
ONGOING WORK AND GUIDANCE THEY

9466
06:20:09,507 --> 06:20:10,174
PUBLISHED.

9467
06:20:10,174 --> 06:20:16,614
I WANTED TO REEMPHASIZING

9468
06:20:16,614 --> 06:20:18,049
INFLUENCING FDA POLICY.

9469
06:20:18,049 --> 06:20:19,684
SO FOR THOSE WHO WANT TO THINK

9470
06:20:19,684 --> 06:20:21,319
ABOUT HOW CAN I INFLUENCE FDA

9471
06:20:21,319 --> 06:20:25,356
POLICY, THEY HAVE A ROADMAP FOR

9472
06:20:25,356 --> 06:20:26,257
THAT.

9473
06:20:26,257 --> 06:20:27,992
AND THEY EMPHASIZED ONGOING FDA

9474
06:20:27,992 --> 06:20:29,093
EVALUATIONS ARE HAPPENING

9475
06:20:29,093 --> 06:20:30,228
PARTICULARLY AROUND SUICIDAL

9476
06:20:30,228 --> 06:20:32,130
THOUGHTS AND ACTIONS, ARE THEY

9477
06:20:32,130 --> 06:20:33,364
MORE COMMON WITH PATIENTS

9478
06:20:33,364 --> 06:20:34,666
TREATED WITH GLP-1s, LOOKING

9479
06:20:34,666 --> 06:20:40,271
FOR WARD TO THOSE RESULTS.

9480
06:20:40,271 --> 06:20:43,541
AND WE HEARD FROM DR. WONG AND

9481
06:20:43,541 --> 06:20:44,976
DR. SKINNER, SO LITTLE EVIDENCE

9482
06:20:44,976 --> 06:20:46,678
IS IS THERE FOR CHILDREN AND WE

9483
06:20:46,678 --> 06:20:50,114
NEED A LOT OF DATA THERE AND

9484
06:20:50,114 --> 06:20:51,983
REAL WORLD DATA CAN BE ONE WAY

9485
06:20:51,983 --> 06:20:55,153
TO BEGIN TO FILL THOSE GAPS AND

9486
06:20:55,153 --> 06:20:56,487
ADDRESS THOSE NEEDS.

9487
06:20:56,487 --> 06:20:57,622
THERE'S OPPORTUNITY TO

9488
06:20:57,622 --> 06:20:59,891
INVESTIGATE HARMS, MENTAL HEALTH

9489
06:20:59,891 --> 06:21:01,726
RISKS, EATING DISORDERS, SOCIAL

9490
06:21:01,726 --> 06:21:03,394
DEVELOPMENT, LONGER-TERM WEIGHT

9491
06:21:03,394 --> 06:21:10,568
AND HEALTH OUTCOMES, QUALITY OF

9492
06:21:10,568 --> 06:21:11,769
LIFE, PATIENT-REPORTED OUTCOMES;

9493
06:21:11,769 --> 06:21:14,505
REDUCING GAPS AND CARE QUALITY

9494
06:21:14,505 --> 06:21:15,907
AND OUTCOMES.

9495
06:21:15,907 --> 06:21:19,010
NOT JUST EVALUATING INDIVIDUAL

9496
06:21:19,010 --> 06:21:20,545
THERAPIES BUT EVALUATING SYSTEM

9497
06:21:20,545 --> 06:21:22,280
LEVEL DECISIONS THAT THEY ARE

9498
06:21:22,280 --> 06:21:26,751
MAKING HOW TO ROLL MEDICATION

9499
06:21:26,751 --> 06:21:29,487
OUT AND LOOKING AT THE NATURAL

9500
06:21:29,487 --> 06:21:32,557
EXPERIMENT IN REAL WORLD HEALTH

9501
06:21:32,557 --> 06:21:34,092
SYSTEMS.

9502
06:21:34,092 --> 06:21:35,860
NEXT THINKING ABOUT ANAND AND

9503
06:21:35,860 --> 06:21:37,161
DAVID'S PRESENTATIONS ABOUT

9504
06:21:37,161 --> 06:21:40,365
PUBLIC AND PRIVATE PAYER

9505
06:21:40,365 --> 06:21:45,937
PERSPECTIVES, MICROSIMULATION

9506
06:21:45,937 --> 06:21:47,305
RESEARCH THAT WAS MENTIONED,

9507
06:21:47,305 --> 06:21:49,774
FOLLOW-UP WINDOW TO HELP INFORM

9508
06:21:49,774 --> 06:21:50,642
MEDICARE POLICY SEEMED REALLY

9509
06:21:50,642 --> 06:21:53,478
IMPORTANT FOR US TO THINK ABOUT

9510
06:21:53,478 --> 06:21:56,447
AS WE DESIGNED FUTURE

9511
06:21:56,447 --> 06:21:58,650
MICROSIMULATION RESEARCH.

9512
06:21:58,650 --> 06:22:01,085
AND THEN TWO COMMENTS ABOUT OR

9513
06:22:01,085 --> 06:22:03,187
IDEAS ABOUT SUBPOPULATIONS WITH

9514
06:22:03,187 --> 06:22:05,123
OBESITY, IDENTIFY THOSE WHO ARE

9515
06:22:05,123 --> 06:22:08,192
MOST LIKELY TO BENEFIT BUT ALSO

9516
06:22:08,192 --> 06:22:09,560
THE POINT WAS EMPHASIZED BY

9517
06:22:09,560 --> 06:22:11,996
DAVID HINES WE NEED TO ENSURE

9518
06:22:11,996 --> 06:22:13,865
THAT POPULATIONS WITH HIGHEST

9519
06:22:13,865 --> 06:22:15,166
NEED GET ACCESS.

9520
06:22:15,166 --> 06:22:18,236
SO THOSE MIGHT NOT BE THE SAME

9521
06:22:18,236 --> 06:22:19,337
POPULATIONS, THOSE MOST LIKELY

9522
06:22:19,337 --> 06:22:21,939
TO BENEFIT AND WITH HIGHEST

9523
06:22:21,939 --> 06:22:22,640
NEEDS, COULD BE DEFINED

9524
06:22:22,640 --> 06:22:27,111
DIFFERENTLY SO LOOKING AT BOTH

9525
06:22:27,111 --> 06:22:32,283
THOSE QUESTIONS SEPARATELY.

9526
06:22:32,283 --> 06:22:33,151
COMBINING DOESN'T LEAD TO

9527
06:22:33,151 --> 06:22:34,152
GREATER BENEFIT.

9528
06:22:34,152 --> 06:22:37,188
DO WE NEED TO PAY FOR BOTH?

9529
06:22:37,188 --> 06:22:39,257
OR WHAT'S THE MINIMUM NECESSARY

9530
06:22:39,257 --> 06:22:41,893
IN TERMS OF LIFESTYLE SUPPORT TO

9531
06:22:41,893 --> 06:22:44,529
COMBINE AOMs SO WE CAN REDUCE

9532
06:22:44,529 --> 06:22:45,930
COST FOR PAYERS AS THEY ARE

9533
06:22:45,930 --> 06:22:49,100
TRYING TO EXPAND COVERAGE AND

9534
06:22:49,100 --> 06:22:54,906
ACCESS FOR THESE.

9535
06:22:54,906 --> 06:22:57,341
NOELIA MENTIONED REAL WORLD

9536
06:22:57,341 --> 06:23:00,611
OBJECTIVES TO SUPPORT ECONOMIC

9537
06:23:00,611 --> 06:23:02,480
EVALUATION FOR CONGRESSIONAL

9538
06:23:02,480 --> 06:23:04,782
BUDGET OFFICE, LONG-TERM

9539
06:23:04,782 --> 06:23:08,186
EFFECTS, ADHERENCE, SUBGROUPS,

9540
06:23:08,186 --> 06:23:09,954
MORTALITY, DISABILITY,

9541
06:23:09,954 --> 06:23:10,254
EMPLOYMENT.

9542
06:23:10,254 --> 06:23:11,189
MENTIONED NATURAL EXPERIMENTS

9543
06:23:11,189 --> 06:23:13,157
THAT EXAMINE THE VARIATIONS IN

9544
06:23:13,157 --> 06:23:14,225
COVERAGE AND COMPARED OUTCOMES

9545
06:23:14,225 --> 06:23:16,194
FOR PEOPLE WITH AND WITHOUT

9546
06:23:16,194 --> 06:23:16,527
COVERAGE.

9547
06:23:16,527 --> 06:23:19,931
THAT'S REALLY INTERESTING TO

9548
06:23:19,931 --> 06:23:21,566
THINK ABOUT USING THOSE ACROSS

9549
06:23:21,566 --> 06:23:23,334
HEALTH SYSTEMS OR DIFFERENT

9550
06:23:23,334 --> 06:23:25,937
TYPES OF DATA TO TRY TO

9551
06:23:25,937 --> 06:23:27,271
TRIANGULATE SOME COVERAGE AND

9552
06:23:27,271 --> 06:23:31,309
POLICY DECISIONS THAT ARE

9553
06:23:31,309 --> 06:23:31,709
HAPPENING.

9554
06:23:31,709 --> 06:23:32,343
OBSERVATIONAL STUDIES COMPARING

9555
06:23:32,343 --> 06:23:34,612
OUTCOMES OF PEOPLE WHO DO AND DO

9556
06:23:34,612 --> 06:23:36,147
NOT TAKE AOMs ADJUSTING FOR

9557
06:23:36,147 --> 06:23:37,014
DIFFERENCES BETWEEN THE GROUPS,

9558
06:23:37,014 --> 06:23:38,683
WE TALKED ABOUT HOW CHALLENGING

9559
06:23:38,683 --> 06:23:40,752
THAT CAN BE TO COMPARE THOSE

9560
06:23:40,752 --> 06:23:43,354
KINDS OF GROUPS WITH UNMEASURED

9561
06:23:43,354 --> 06:23:45,323
CONFOUNDING AND TARGET TRIAL

9562
06:23:45,323 --> 06:23:46,758
EMULATION PROCESS COULD HELP US

9563
06:23:46,758 --> 06:23:48,893
SPECIFY WHEN THAT MIGHT BE A

9564
06:23:48,893 --> 06:23:52,463
GOOD SET TIME TO DO THAT OR NOT

9565
06:23:52,463 --> 06:23:53,765
BUT IT'S IMPORTANT TO NOTE

9566
06:23:53,765 --> 06:23:56,834
PAYERS WANT TO KNOW THE ANSWER

9567
06:23:56,834 --> 06:23:59,337
TO THESE QUESTIONS.

9568
06:23:59,337 --> 06:24:01,939
AND THEN IN SESSION 3,

9569
06:24:01,939 --> 06:24:04,275
INTERESTING IDEAS COMING OUT OF

9570
06:24:04,275 --> 06:24:07,445
ANIA AND LESLEY'S CONVERSATION

9571
06:24:07,445 --> 06:24:10,381
AND PRESENTATION ABOUT OTHER

9572
06:24:10,381 --> 06:24:11,015
ALTERNATIVE TITRATION PROTOCOLS

9573
06:24:11,015 --> 06:24:12,917
THAT COULD BE USED TO REDUCE

9574
06:24:12,917 --> 06:24:16,287
SIDE EFFECTS AND IMPROVE

9575
06:24:16,287 --> 06:24:19,257
LONG-TERM ADHERENCE, AND HOW DO

9576
06:24:19,257 --> 06:24:21,759
WE PAIR NUTRITION AND PHYSICAL

9577
06:24:21,759 --> 06:24:24,395
ACTIVITY TO IMPROVE

9578
06:24:24,395 --> 06:24:27,465
TOLERABILITY, ADHERENCE,

9579
06:24:27,465 --> 06:24:28,666
OUTCOMES.

9580
06:24:28,666 --> 06:24:32,503
AND MOST PATIENTS THAT STOP

9581
06:24:32,503 --> 06:24:34,238
AOMs STOP ONCE AND THEN

9582
06:24:34,238 --> 06:24:35,573
RESTART AND NEVER STOP AGAIN.

9583
06:24:35,573 --> 06:24:37,308
I'M INTERESTED TO SEE CAN WE SEE

9584
06:24:37,308 --> 06:24:39,510
THAT IN REAL WORLD DATA?

9585
06:24:39,510 --> 06:24:41,612
AND CAN WE STUDY THAT?

9586
06:24:41,612 --> 06:24:43,481
WHAT'S THE DURATION OF STOPPING,

9587
06:24:43,481 --> 06:24:45,583
WHAT'S THE HEALTH IMPACT OF

9588
06:24:45,583 --> 06:24:46,884
STOPPING, AND THEN SORT OF

9589
06:24:46,884 --> 06:24:50,488
WHAT'S THE PATTERN OF ADHERENCE

9590
06:24:50,488 --> 06:24:55,593
WHEN THEY RESTART?

9591
06:24:55,593 --> 06:25:01,432
PRAGMATIC TRIALS, THEY ARE

9592
06:25:01,432 --> 06:25:05,369
RELEVANT, WE TALKED ABOUT IT,

9593
06:25:05,369 --> 06:25:07,538
COMPARING ALTERNATIVES HEAD TO

9594
06:25:07,538 --> 06:25:12,476
HEAD, TESTING STRATEGIES FOR

9595
06:25:12,476 --> 06:25:15,546
TAPERING AOMs, USING-TERM

9596
06:25:15,546 --> 06:25:17,615
AOMs, ANTI-OBESITY MEDICATION,

9597
06:25:17,615 --> 06:25:19,317
WITH LIFESTYLE INTERVENTIONS.

9598
06:25:19,317 --> 06:25:24,322
TESTING STRATEGIES HEAD TO HEAD

9599
06:25:24,322 --> 06:25:25,723
IN PRAGMATIC SETTINGS MIGHT BE

9600
06:25:25,723 --> 06:25:28,259
BETTER THAN TARGET TRIALS.

9601
06:25:28,259 --> 06:25:30,194
THERE WAS NOTES THAT WERE

9602
06:25:30,194 --> 06:25:31,863
IMPORTANT ABOUT REAL CHALLENGES

9603
06:25:31,863 --> 06:25:34,732
IN COMPARING AGAINST USUAL CARE

9604
06:25:34,732 --> 06:25:36,701
AND NON-AOM TREATMENTS, MIGHT

9605
06:25:36,701 --> 06:25:39,570
NOT BE WELL RECEIVED AND USUAL

9606
06:25:39,570 --> 06:25:41,839
CARE KEEPS CHANGING RAPIDLY,

9607
06:25:41,839 --> 06:25:44,041
DEFINING USUAL CARE NOW BUT A

9608
06:25:44,041 --> 06:25:46,110
YEAR FROM NOW USUAL CARE GROUP

9609
06:25:46,110 --> 06:25:49,413
LOOKS DIFFERENT.

9610
06:25:49,413 --> 06:25:53,150
LOTS OF CHALLENGES. 

9611
06:25:53,150 --> 06:25:57,221
CLOSING UP WITH MIGUEL'S

9612
06:25:57,221 --> 06:25:58,956
CONVERSATION, HE WAS POINTING

9613
06:25:58,956 --> 06:26:01,158
TOWARD TARGET TRIAL EMULATION

9614
06:26:01,158 --> 06:26:04,262
APPROACH, HIGHLY VALUABLE AND

9615
06:26:04,262 --> 06:26:06,664
SPECIFYING AND THIS KIND OF

9616
06:26:06,664 --> 06:26:09,033
CLARITY AROUND ASSUMPTION THAT

9617
06:26:09,033 --> 06:26:13,204
GO INTO A TARGET TRIAL, AND IT'S

9618
06:26:13,204 --> 06:26:15,606
IMPORTANT TO THINK THAT IN THIS

9619
06:26:15,606 --> 06:26:18,109
RAPIDLY CHANGING LANDSCAPE WE

9620
06:26:18,109 --> 06:26:20,978
COULD HAVE FASTER REACTION TIME,

9621
06:26:20,978 --> 06:26:22,179
FASTER EVIDENCE GENERATION, WITH

9622
06:26:22,179 --> 06:26:24,382
REAL WORLD DATA STUDIES, PERHAPS

9623
06:26:24,382 --> 06:26:25,683
IN PRAGMATIC TRIALS.

9624
06:26:25,683 --> 06:26:27,652
SO, I THOUGHT THAT WAS AN

9625
06:26:27,652 --> 06:26:29,520
INTERESTING COMMENT THAT HE

9626
06:26:29,520 --> 06:26:29,754
MADE.

9627
06:26:29,754 --> 06:26:32,023
HE COMMENTED THAT WE DON'T HAVE

9628
06:26:32,023 --> 06:26:34,425
TO DO FIVE-YEAR PRAGMATIC

9629
06:26:34,425 --> 06:26:34,659
TRIALS.

9630
06:26:34,659 --> 06:26:36,961
LET'S THING ABOUT SHORTER

9631
06:26:36,961 --> 06:26:38,362
PRAGMATIC TRIALS THAT SORT OF

9632
06:26:38,362 --> 06:26:40,031
GIVE US CLEAR INITIAL EVIDENCE

9633
06:26:40,031 --> 06:26:42,967
AND THAT HELPS US INFORM WHAT

9634
06:26:42,967 --> 06:26:45,036
THE FUTURE LONGER-TERM PRAGMATIC

9635
06:26:45,036 --> 06:26:46,470
TRIALS MIGHT BE.

9636
06:26:46,470 --> 06:26:49,307
BUT THE TARGET TRIALS WERE ALSO

9637
06:26:49,307 --> 06:26:51,409
REALLY GOOD FOR EXAMINING OFF

9638
06:26:51,409 --> 06:26:52,610
LABEL USE OF MEDICATIONS, AND SO

9639
06:26:52,610 --> 06:26:53,811
I THOUGHT THAT WAS ANOTHER

9640
06:26:53,811 --> 06:26:55,980
IMPORTANT POINT FOR US TO BE

9641
06:26:55,980 --> 06:26:57,515
THINKING ABOUT WHERE THIS SWEET

9642
06:26:57,515 --> 06:26:59,517
SPOT IS FOR TARGET TRIALS.

9643
06:26:59,517 --> 06:27:01,452
THAT'S MY QUICK SUMMARY.

9644
06:27:01,452 --> 06:27:04,188
I WANTED TO TURN TO OVERALL

9645
06:27:04,188 --> 06:27:05,323
DISCUSSION BETWEEN THE CO-CHAIRS

9646
06:27:05,323 --> 06:27:07,458
AND THEN WE CAN WRAP UP FOR THE

9647
06:27:07,458 --> 06:27:13,497
DAY AND TALK ABOUT THE AGENDA

9648
06:27:13,497 --> 06:27:14,465
FOR TOMORROW.

9649
06:27:14,465 --> 06:27:15,733
WHAT ELSE WOULD YOU ADD FROM

9650
06:27:15,733 --> 06:27:17,535
YOUR REFLECTIONS ON THE DAY,

9651
06:27:17,535 --> 06:27:17,969
DARREN AND LESLEY?

9652
06:27:17,969 --> 06:27:21,806
>>  I THOUGHT THAT WAS AN

9653
06:27:21,806 --> 06:27:22,573
AMAZING SUMMARY, DAVID.

9654
06:27:22,573 --> 06:27:27,511
I DON'T HAVE MUCH TO ADD.

9655
06:27:27,511 --> 06:27:29,714
I ENCAPSULATED THE KEY -- MANY

9656
06:27:29,714 --> 06:27:32,650
KEY POINTS PEOPLE MADE.

9657
06:27:32,650 --> 06:27:33,884
THANK YOU.

9658
06:27:33,884 --> 06:27:34,285
DARREN?

9659
06:27:34,285 --> 06:27:44,562
>>  NO, I AGREE.

9660
06:27:45,529 --> 06:27:47,198
IT'S REMARKABLE SO MANY

9661
06:27:47,198 --> 06:27:49,400
UNANSWERED QUESTIONS BUT AT THE

9662
06:27:49,400 --> 06:27:52,303
SAME TIME THERE ARE SEVERAL

9663
06:27:52,303 --> 06:27:53,337
THINGS THAT CONSISTENTLY

9664
06:27:53,337 --> 06:27:56,407
MENTIONED THROUGHOUT THE DAY,

9665
06:27:56,407 --> 06:27:56,741
RIGHT?

9666
06:27:56,741 --> 06:28:01,312
SO I JOTTED DOWN SOMETHING NOT

9667
06:28:01,312 --> 06:28:01,979
COMPREHENSIVE, LONG-TERM

9668
06:28:01,979 --> 06:28:04,281
OUTCOMES, ADHERENCE, HOW TO PAY

9669
06:28:04,281 --> 06:28:07,251
FOR THIS, AND WHETHER OR HOW TO

9670
06:28:07,251 --> 06:28:11,822
EITHER TAPER OFF OR STOP THE

9671
06:28:11,822 --> 06:28:12,223
TREATMENT.

9672
06:28:12,223 --> 06:28:16,093
SO MANY OF THESE ARE MENTIONED

9673
06:28:16,093 --> 06:28:18,629
BY MULTIPLE SPEAKERS AS KEY GAP

9674
06:28:18,629 --> 06:28:20,264
AREAS TO THE FIELD, POTENTIALLY

9675
06:28:20,264 --> 06:28:23,434
FILLED BY REAL WORLD DATA

9676
06:28:23,434 --> 06:28:23,901
ANALYSIS.

9677
06:28:23,901 --> 06:28:25,636
I'M STRUCK BY THE FACT WE

9678
06:28:25,636 --> 06:28:28,472
COVERED SO MANY BASES AND THEN

9679
06:28:28,472 --> 06:28:30,541
THERE'S ALSO A SET OF THEMES

9680
06:28:30,541 --> 06:28:32,743
THAT KEEP OCCURRING BY DIFFERENT

9681
06:28:32,743 --> 06:28:37,348
SPEAKERS AND BY THE ATTENDEES OF

9682
06:28:37,348 --> 06:28:38,315
THE WORKSHOP.

9683
06:28:38,315 --> 06:28:38,616
>> GREAT.

9684
06:28:38,616 --> 06:28:40,084
THANK YOU, DARREN.

9685
06:28:40,084 --> 06:28:42,053
THANK YOU, LESLEY, AS WELL.

9686
06:28:42,053 --> 06:28:43,587
AND THANK YOU, EVERYONE WHO

9687
06:28:43,587 --> 06:28:45,756
STUCK WITH US THROUGHOUT THE DAY

9688
06:28:45,756 --> 06:28:45,956
TODAY.

9689
06:28:45,956 --> 06:28:49,360
I'M SURE YOU WON'T MIND IF  WE

9690
06:28:49,360 --> 06:28:50,294
GIVE YOU FOUR MINUTES BACK IN

9691
06:28:50,294 --> 06:28:51,162
THE SCHEDULE.

9692
06:28:51,162 --> 06:28:53,798
WE HAVE ANOTHER FUN DAY TOMORROW

9693
06:28:53,798 --> 06:28:54,131
PLANNED.

9694
06:28:54,131 --> 06:28:55,766
LET ME SHARE MY SCREEN AND GIVE

9695
06:28:55,766 --> 06:29:02,239
YOU A QUICK OVERVIEW OF WHERE

9696
06:29:02,239 --> 06:29:03,974
WE'RE GOING WITH THAT.

9697
06:29:03,974 --> 06:29:05,976
TOMORROW WE'RE BE TALKING ABOUT

9698
06:29:05,976 --> 06:29:08,045
BEST PRACTICES FOR STUDYING

9699
06:29:08,045 --> 06:29:09,380
GLP-1 THERAPIES.

9700
06:29:09,380 --> 06:29:10,581
DEFINING EXPOSURES AND OUTCOMES,

9701
06:29:10,581 --> 06:29:12,550
GETTING INTO THE WEEDS OF SOME

9702
06:29:12,550 --> 06:29:13,984
OF THE NITTY-GRITTY CHALLENGES

9703
06:29:13,984 --> 06:29:19,523
OF HOW YOU DO REAL WORLD

9704
06:29:19,523 --> 06:29:21,859
STUDIES, USING GLP-1-BASED

9705
06:29:21,859 --> 06:29:22,693
THERAPY.

9706
06:29:22,693 --> 06:29:23,894
DEFINE EXPOSURE, DEFINING

9707
06:29:23,894 --> 06:29:26,297
OUTCOMES, FOCUS IN ON VERY

9708
06:29:26,297 --> 06:29:27,465
SPECIFIC HEALTH CONDITIONS AND

9709
06:29:27,465 --> 06:29:29,066
CHALLENGES OF DOING REAL WORLD

9710
06:29:29,066 --> 06:29:30,167
DATA STUDIES THERE.

9711
06:29:30,167 --> 06:29:32,036
WE'LL END WITH A MODERATED

9712
06:29:32,036 --> 06:29:33,737
DISCUSSION ABOUT THE KEY

9713
06:29:33,737 --> 06:29:35,739
RESEARCH GAPS AND OPPORTUNITIES,

9714
06:29:35,739 --> 06:29:36,574
BRINGING TOGETHER EVERYTHING

9715
06:29:36,574 --> 06:29:38,676
ACROSS BOTH DAYS AND TRYING TO

9716
06:29:38,676 --> 06:29:40,778
PUT TOGETHER KEY THEME AREAS FOR

9717
06:29:40,778 --> 06:29:42,646
US TO TAKE AWAY AND HOPEFULLY

9718
06:29:42,646 --> 06:29:44,715
BUILD ON THE EVIDENCE BASE AS WE

9719
06:29:44,715 --> 06:29:45,583
MOVE FORWARD.

9720
06:29:45,583 --> 06:29:54,125
I WANT TO THANK MY CO-CHAIRS,

9721
06:29:54,125 --> 06:29:56,093
FOR THE HELP IN PREPARING THE

9722
06:29:56,093 --> 06:29:57,728
SESSION, AND EVERYONE INVOLVED

9723
06:29:57,728 --> 06:29:58,362
AS SPEAKERS.

9724
06:29:58,362 --> 06:29:59,130
GREAT DAY.

9725
06:29:59,130 --> 06:30:07,905
WE'LL SEE YOU AGAIN TOMORROW

9726
06:30:07,905 --> 06:30:08,139
MORNING.

9727
06:30:08,139 --> 06:30:11,709
>> THANK YOU FOR THE
EXCELLENT

9728
06:30:11,709 --> 06:30:11,942
SUMMARY.

9729
06:30:11,942 --> 06:30:14,145
THANK YOU FOR LEADING US THROUGH

9730
06:30:14,145 --> 06:30:14,845
THAT.

9731
06:30:14,845 --> 06:30:15,980
WE'LL ADJOURN FOR DAY 1.

9732
06:30:15,980 --> 06:30:17,314
PLEASE COME BACK TOMORROW

9733
06:30:17,314 --> 06:30:17,648
MORNING.

9734
06:30:17,648 --> 06:30:20,584
THANKS FOR GIVING US A PREVIEW

9735
06:30:20,584 --> 06:30:23,554
OF WHAT WE'RE GOING TO SEE

9736
06:30:23,554 --> 06:30:24,421
TOMORROW.

9737
06:30:24,421 --> 06:30:25,956
TOMORROW'S SESSION STARTS AT 10

9738
06:30:25,956 --> 06:30:26,624
A.M., EASTERN TIME.

9739
06:30:26,624 --> 06:30:27,391
SEE YOU THEN.

9740
06:30:27,391 --> 06:30:37,391
HAVE A GOOD EVENING.