>> WELCOME TO THIRD ANNUAL NIH
LEAL INVESTIGATOR MEETING
AFTERNOON SESSIONMENT MY NAME IS
JENNIFER, GIL LIRKSSON WITH THE
PLANNING TEAM AND WE WILL
PROVIDE LOGISTICS SUPPORT FOR
THE SESSION SESSION. TO ASK QUESTIONS
OPEN THE CHAT BOX ANT BOTTOM OF
THE INTERFACE. CLICK ON THE
ICON AND THIS WILL PULL UP THE
CHAT BOX TO RIGHT SIDE OF THE
ZOOM INTERFACE. USE THE RAISE
HAND FUNCTION UNDER REACTIONS
AND WHICH WILL UNMUTE YOU TO
VERBALLY ASK QUESTIONS DURING
THE Q&A PORTION OF THE SESSION.
ADDITIONALLY WE ASK YOU SELECT
SPEAKER VIEW OPTION ON THE RIGHT
SIDE OF THE ZOOM INTERFACE TO
ALLOW YOU TO SEA SPEAKERS AS HAY
PRESENT OR SHARE INFORMATION.
ANY TECHNICAL ASSISTANCE DURING
THE SESSION PLEASE TYPE INTO THE
CHAT BOX AND ONE OF OUR TECH
ALSO RESPOND TO YOU. PLEASE BE
AWARE TODAY'S SESSION IS BEING
RECORDED, CLOSE CAPTIONING IS
AVAILABLE BY CLICKING THE CC
ICON AT THE BOTTOM OF THE
SCREEN. ALL PHONE AND COMPUTER
LINES HAVE BEEN MUTED AND I WILL
NOW TURN IT TO DR. BAKER.
>> THANK YOU, WELCOME BACK
EVERYONE. IT'S BEEN AN EXCITING
AND PRODUCTIVE DAY AND A HALF SO
FAR. I HAD A CHANCE TO VISIT A
FEW OF YOU IN THE DISCUSSION
SECTIONS AND POSTERS AND IT IS
TERRIFIC TO SEE THE PROGRESS
THAT'S BEING MADE ON SO MANY
FRONTS. AND THE CREATIVITY AND
DEDICATION WHICH OUR RESEARCH
COMMUNITIED IS TACKLING THE PAIN
AND OVERDOSE CRISES. SO NOW
REALLY LOOKING FORWARD TO THIS
NEXT SECTION, WHICH DR. TABAK
ACTING DIRECTOR OF THE NATIONAL
INSTITUTES OF HEALTH WILL LEAD.
WE WILL HAVE THE DISTINCT HONOR
OF HEARING FROM LEADERSHIP OF IF
NUMBER OF OUR FEDERAL PARTNERS
ABOUT HOW THEIR AGENCIES ARE
TAKING ON THE OVERDOSE EPIDEMIC
AND HOW WE ARE WORKING TOGETHER
TO PROVIDE SOLUTIONS FOR
(INAUDIBLE). DR. TABAK.
>> THANKS VERY MUCH, DR. BAKER.
WELCOME BACK TO WHAT IS A FINAL
PLENARY SESSION OF THE THIRD
ANNUAL NIH HEAL INITIATIVE
INVESTIGATOR MEETING. CERTAINLY
I HOPE YOU HAVE HAD A
STIMULATING AND INFORMATIVE SET
OF EXCHANGES WITH YOUR
COLLEAGUES DURING THE DISCUSSION
GROUPS SO THROUGHOUT THE
MEETING. OVER THE PAST COUPLE OF
DAYS, YOU HAVE SEEN AND HEARD A
LOT OF DATA THAT'S INFORMING
WHAT WE KNOW ABOUT THE CAUSES,
PREVENTION AND TREATMENT OF
SUBSTANCE USE DISORDERS AND
CHRONIC PAIN. AND YOU HAVE ALSO
HEARD ABOUT THE MANY CHALLENGES
FACED BY PEOPLE LIVING WITH
THESE CONDITIONS AND THEIR
CAREGIVERS WHO FACE MANY
OBSTACLES. OF COURSE THE
RESEARCH COMMUNITY CAN ONLY DO
SO MUCH TO OVERCOME THESE
CHALLENGES. BUT WHAT WE CAN DO
IS TEAM WITH FEDERAL PARTNERS
FOR DRUG APPROVALS AS WELL AS
POLICIES AND GUIDELINES FOR
TREATMENT AND REIMBURSEMENT AND
HEAL REMAINS COMMITTED TO TRY TO
MAKE CONNECTIONS BETWEEN
RESEARCH AND PRACTICE THAT
INVOLVES COORDINATION OF -- WITH
THESE AGENCIES. SO TO NOT JUST
TODAY AT THIS MEETING BUT JUST
ABOUT EVERY WEEK IN THE MANY
MEETINGS THAT HEAL AND NIH STAFF
PARTICIPATE IN. AS THIS
INVESTIGATOR MEETING COMES THE A
CLOSE, WE ARE GOING TO NOW SPEAK
WITH FEDERAL COLLEAGUES ABOUT
THE RELATIONSHIP BETWEEN
RESEARCH AND PREVENTION AND
TREATMENT COMMUNITIES FOCUSED ON
FINDING SCIENTIFIC SOLUTIONS TO
THE CURRENT CRISES. JOINING ME
THIS AFTERNOON ARE THREE
INDIVIDUALS WHO HAVE HIGH STAKES
IN ADDRESSING THE OPIOID AND
PAIN CRISIS. DR. CALIFF TOOK
OVER POSITION OF COMMISSIONER OF
FOOD AND DRUGS AT THE U.S. FOOD
AND DRUG ADMINISTRATION IN
FEBRUARY OF THIS YEAR. MANY OF
YOU KNOW THIS IS ACTUALLY DR.
CALIFF'S SECOND TOUR IN THIS
POSITION HAVING ALREADY SERVED
AS FDA COMMISSIONER FROM
FEBRUARY 2016 THROUGH JANUARY
2017. DR. CALIFF HAD A LONG
DISTINGUISHED CAREER, A CLINICAL
RESEARCH IS RECOGNIZED EXPERT IN
HOW -- HEALTH OUTCOMES RESEARCH
AND HEALTHCARE QUALITY, HE
SERVED AS PROFESSOR OF MEDICINE
AND VICE CHANCELLOR FOR CLINICAL
TRANSLATIONAL RESEARCH AT DUKE.
AND WAS HEAD OF MEDICAL STRATEGY
AND SENIOR ADVISOR AT ALPHABET
INC.. ALSO ON OUR PANEL IS DR.
DEB HOURY, ACTING PRINCIPLE
DEPUTY DIRECTOR AND DIRECTOR OF
THE NATIONAL CENTER FOR INJURY
PREVENTION AND CONTROL AT THE
CENTERS FOR DISEASE CONTROL AND
PREVENTION. HER OFFICE AMONG
NUMEROUS OTHER FUNCTIONS
PROVIDES SUPPORT FOR KEY
PROGRAMS THAT AIDS STATES
PREVENTING PRESCRIPTION DRUG
OVERDOSES, OFFERING RESOURCES
AND DIRECT SUPPORT OF THE CDC TO
ADVANCE PROMISING PREVENTION
STRATEGIES PRIOR TO JOINING THE
CDC DR. HOURY GATHERED EXTENSIVE
EXPERIENCE AT THE FRONT LINES OF
THE HEALTHCARE SYSTEM AS AN
EMERGENCY DEPARTMENT PHYSICIAN
AND RESEARCHER. FINALLY I
WELCOME ALSO DR. MIRIAM RITTMON,
SENT SECRETARY FOR MENTAL HEALTH
AND SUBSTANCE USE IN THE U.S.
DEPARTMENT OF HEALTH AND HUMAN
SERVICES AND ADMINISTRATOR OF
THE SUBSTANCE ABUSE AND MENTAL
HEALTH SERVICES ADMINISTRATION
BEFORE JOINING SAMSA SHE HELD
SEVERAL POSITIONS AT THE
CONNECTICUT DEPARTMENT OF MENTAL
HEALTH AND ADDICTION SERVICES
AND WAS ON THE FACULTY FOR MANY
YEARS AT YALE UNIVERSITY.
DURING HER CAREER IN THE
BEHAVIORAL HEALTH FIELD DR.
DELPHIN RITTMON GAINED EXTENSIVE
EXPERIENCE IN DESIGN EVALUATION
AND ADMINISTRATION OF MENTAL
HEALTH, SUBSTANCE USE AND
PREVENTION SERVICES AND SYSTEMS.
SO WHAT BETTER WAY TO SHAPE OUR
DISCUSSION TODAY THAN TO TAKE
CORRECTIONS DIRECTLY FROM THE
HEAL RESEARCH COMMUNITY, SO
DURING THIS SESSION WE WILL
ADDRESS SOME OF THOSE QUESTIONS,
COMMENTS AND CONCERNS BUT BEFORE
THAT WE WOULD LIKE TO HEAR FROM
YOU ABOUT HOW YOUR AGENCY IS
TAKING ON THIS EPIDEMIC UNDER
THE NEW HHS OVERDOSE PREVENTION
STRATEGY. IF WE MAY I WOULD LIKE
TO BEGIN WITH DR. HOURY. DEB, IF
YOU WOULD LIKE TO BEGIN, PLEASE.
>> THANKS SO MUCH, GREAT TO BE
WITH YOU VIRTUALLY TODAY BEFORE
THIS SESSION, REBECCA AND I WERE
TALKING AND I REMEMBER
PRESENTING TO THIS GROUP IN
PERSON BEFORE AND HOPEFULLY WE
WILL GET TO THAT AGAIN SOON. BUT
NIH HEAL INITIATIVE JUST PLAYS
SUCH AN INSTRUMENTAL ROLE
COMBATING THE DRUG OVERDOSE
EPIEPIDEMIC AND ENDING ADDICTION
LONG TERM. YOUR WORK IN THIS
PROGRAM IS SO IMPORTANT AND I
HAVE BEEN VALUABLE. --
INVALUABLE. AS I KNOW YOU KNOW,
DRUG OVERDOSE DEATHS WERE GOING
UP PRE-PANDEMIC AND CERTAINLY
ACCELERATED DURING THE PANDEMIC
RISING NEARLY 30%. WE CONTINUE
TO SEE RECORD NUMBERS OF
OVERDOSE DEATHS. CDC WORKED HARD
WITH PARTNERS SUCH AS YOU AS
WELL AS FEDERAL PARTNERS TO
PREVENT SUBSTANCE USE DISORDER
OVERDOSE. SUPPORT RAPID RESPONSE
AND REACH PEOPLE WHO ARE
STRUGGLING WITH SUBSTANCE USE AN
LINK TO LIFE SAVING SERVICES
AMID THE PANDEMIC. WE HAVE ALSO
SEEN CHANGES TO POLICIES TO HELP
INDIVIDUALS OBTAIN TREATMENT AND
RESOURCES. AN EXAMPLE IS
TOGETHER WITH SAMSA WE ANNOUNCE
FEDERAL FUNDING MAYBE USED TO
PURCHASE RAPID TEST STRIPS IN AN
EFFORT TO CURB THE DRAMATIC
SPIKE IN DRUG OVERDOSE DEATHS.
AS MENTIONED HHS RECENTLY
RELEASED ITS OVERDOSE PREVENTION
STRATEGY WHICH FULLY ADDRESSES
THE SPECTRUM OF DRUG USE AN
ADDICTION THAT CAN RESULT IN
OVER DOSE AND DEATH. CDC WAS
PROUD TO BE CALIBRATOR DURING
THE DEVELOPMENT OF THE STRATEGY
AND OUR WORK WITHIN CDN
COMPLIMENTS HHS STRATEGY
SUPPORTING OUR NEED TO EVOLVE
WITH THE DRUG CRISIS AS WE
ENSURE ACTIVITIES ARE BEING
IMPLEMENT WITH THE HEALTH EQUITY
LENS. PROGRAMS ACROSS THE CDC
HAVE FOCUSED ON THINGS SUCH AS
OPIOID USE DISORDER, HEPATITIS,
AND HIV INFECTIONS ASSOCIATED
DRUG USE AND NEONATAL ABSTINENCE
SYNDROME. OVERDOSE PREVENTION
EFFORTS ARE CURRENTLY
PRIORITIZED IN FIVE STRATEGIC
AREAS, WHICH INCLUDE BUILDING
STATE TRIBAL LOCAL AND
TERRITORIAL CAPACITY. SUPPORTING
PROVIDERS, HEALTH SYSTEMS PAYERS
AND EMPLOYERS, PARTNERING WITH
PUBLIC SAFETY AND COMMUNITY
ORGANIZATIONS. RAISING PUBLIC
AWARENESS AND REDUCING STIGMA STIGMA.
AND MONITORING ANALYZING AND
COMMUNICATING TRENDS TO DRIVE
ACTION. WE ARE CURRENTLY
SUPPORTING 47 STATES, DC,
TERRITORIES AND HIGH BURDEN
COUNTIES THROUGH THE ACTION DATA
PROGRAM. WHAT I FIND INNOVATIVE
ABOUT THIS IS RECIPIENTS COLLECT
TIMELY DATA ON OVERDOSES AND
THEN USE THESE DATA TO INFORM
PREVENTION EFFORTS. AN EXAMPLE
OF THIS IS JEFFERSON COUNTY
RECEIVED REAL TIME OVERDOSE DATA
AND USE THESE TO DEPLOY RAPID
RESPONSE TEAMS TO LOCAL YARRS
EXPERIENCING OUTBREAKS. WE ALSO
REALIZING THE IMPACT THE
PANDEMIC HAD ON OUR HEALTH
DEPARTMENT ANNOUNCE ADDITIONAL
FOURTH YEAR OF LEVEL FUNDING FOR
OUR RECIPIENTS AND WITH THIS
ADDITION WE EXPANDED THE SCOPE
OF THE PROGRAM TO DISCUSS
POLYSUBSTANCE USE AS WELL AS
ELICIT STIMULUS. STIMULANTS. WE
ALSO DEVELOPED HARM REDUCTION
RESOURCE GUIDE TO PROVIDE
GUIDANCE ON RECIPIENTS ON WHAT
WERE ALLOWING ACTIVITIES SUCH AS
OVERDISEDUCATION, PURCHASING
DISTRIBUTING FENTANYL TEST
STRIPS AN EDUCATION ON SAFER
DRUG USE PRACTICES AMONG OTHER
STRATEGIES. AT CDC TIMELY DATA
IS REALLY IMPORTANT. WE
COORDINATE THROUGH PARTNERS SUCH
AS LAW ENFORCEMENT AND PUBLIC
HEALTH AND HEALTHCARE PROVIDERS.
OUR DRUG OVERDOSE SURVEILLANCE
AND EPI SYSTEM OR DOSE PULLS
TOGETHER ELECTRONIC HEALTH
RECORD DATA TO IDENTIFY
OUTBREAKS AND PROVIDE
SITUATIONAL AWARENESS. LAST
WEEK WE RELEASED OUR NEW
DASHBOARD WHICH INCLUDES DATA
FROM 42 STATES INCLUDING D.C. ON
ALL DRUG OPIOID HEROIN AND
STIMULANT OVERDOSES AND WILL
CONTINUE TO BE UPDATE WITH
NEWEST DATA EACH MONTH. WE ARE
ALSO EXPLORING DATA SCIENCE
METHODS TO FACILITATE REAL TIME
DATA, AS WELL AS PREDICTIVE
ANALYTICS AND THINGS SUCH AS
CLOUD BASED TECHNOLOGIES TO
IMPROVE ACCESS TIMELINESS OF
INJURY HEALTH DATA SETS AND
EXTERNAL DATA SETS SUCH AS
TWITTER AND REDDIT. WE KNOW
STIGMA RELATED TO USING DRUGS
CAN BE A SIGNIFICANT BARRIER TO
GETTING HELP AND COMBATING
STIGMA IS A KEY COMPONENT OF THE
HHS OVERDOSE PREVENTION
STRATEGY. WE RECENT WILL I
LAUNCHED SEVERAL EDUCATION
CAMPAIGNS INTENDED TO REACH
YOUNG ADULTS 18-34 AND PROVIDE
INFORMATION ABOUT THE PREVALENCE
AN DANGERS OF FENTANYL, RISKS
AND CONSEQUENCES OF MIXING
DRUGS, AS WELL AS THE LIFE
SAVING POWER OF NALOXONE AND
REDUCING STIGMA AROUND DRUG USE
TO SUPPORT TREATMENT AND
RECOVERY. WE WORK DIRECTLY WITH
YOUNG ADULTS WHO REPORTED DRUG
USE, AS WELL AS PEER RECOVERY
PROFESSIONALS TO DEVELOP THESE
CAMPAIGNS. MANY OF YOU ARE
HOPEFULLY AWARE THAT WE ARE
UPDATING OUR 2016 GUIDELINES,
THE DRAFT GUIDELINE WAS POSTED
IN THE FEDERAL REGISTER WHICH
CLOSED EVENTUALLY AFTER A 60 DAY
PUBLIC COMMENT PERIOD. MORE THAN
4,000 COMMENTS WE LOOK FORWARD
TO INCORPORATING IN THIS. HI DID
WANT TO THANK NIH ANIDA SAMSHA
FDA AND IHS FOR SERVING ON
FEDERAL ADVISORY COMMITTEE FOR
THIS IMPORTANT EFFORT. OUR GOAL
IS TO RELEASE THIS GUIDELINE IN
LATE 2022. FINALLY I WANT TO
MENTION THAT MUCH OF OUR WORK IN
RECENT YEARS IS FOCUSED ON
THINGS SUCH AS EXPANDING
TREATMENT AND HARM REDUCTION BUT
WE CANNOT LOSE SITE OF THE
IMPORTANCE OF REVENGES AND ONE
OF THE WAYS WE HAVE DOING THIS
IS THROUGH OUR MANAGEMENT DRUG
FREE COMMUNITIES PROGRAM,
DIRECTED BY ONDCP THIS PROGRAM
FROM SLIDES GRANTS TO COMMUNITY
COALITIONS TO ESTABLISH AND
STRENGTHEN LOCAL PARTNERS TO
IMPLEMENT LOCAL USE PREVENTION
AND MORE THAN 700 COMMUNITY
COALITIONS ARE PARTICIPATING IN
THIS PROGRAM AND CREATING THAT
INFRASTRUCTURE TO REDUCE NEW
SUBSTANCE USE. DURING THE
COVID-19 PANDEMIC, WE HAVE SEEN
REALLY INNOVATIVE NEW PROGRAMS
SUCH AS PARTNERSHIP FOR DRUG
FREE ST. JOSEPH COUNTY WORK WITH
YOUTH ON A VIDEO CONTEST AND RED
CARPET EVENT, BUILT A
PARTNERSHIP WITH LOCAL TV KNEW
STATIONS REALLY PREVENTING
STRESS AND UNDERAGE DRINKING. SO
IN CLOSING I WANT TO UNDERSCORE
NEED FOR HOLISTIC APPROACH TO
ADDRESSING THE EVOLVING
ESCALATING OVERDOSE CRISIS, WE
HAVE TO FOCUS ON TREATMENT
RECOVERY AND HARM REDUCTION
WHILE ALSO MAKING CRITICAL
INVESTMENTS IN UPSTREAM
PREVENTION THAT PROTECT AGAINST
SUBSTANCE USE INITIATION IN THE
FIRST PLACE. I WOULD LIKE TO
THANK NIH NIDA AND MY
CO-PANELISTS FOR THEIR CONTINUED
PARTNERSHIP AS WE WORK TO
PREVENT DRUG OVERDOSE AND
IMPACTS OF SUBSTANCE USE. LOOK
FORWARD TO TODAY'S DISCUSSION.
>> THANK YOU SO MUCH FOR THAT
COMPREHENSIVE OVERVIEW. AND IN
THE CHAT BOX ARE KUDOS ABILITY
YOUR FOCUS ON PREVENTION SO
PROBABLY STARTING POINT TO
CONVERSATION TO FOLLOW. NEXT WE
WILL HEAR FROM DR. CALIFF.
>> THANKS, LARRY, GOOD TO BE
WITH YOU. I AM ON SECOND TOUR
BUT EARLY ON SECOND TOUR. WHAT
I'M GOING TO SAY TODAY PARTLY
REFLECTS MY OWN OPINION AND
PARTLY DEPTH OF UPDATING ABOUT
WHAT'S HAPPENED SINCE 2016 AT
THE FDA ON THIS TOPIC. FIRST A
BRIEF UPDATE ON MY HISTORY
RELATED TO THIS. THAT WILL
FLAVOR SOME OF OUR REMARKS. I
WAS INVOLVED 20 YEARS IN THE
NIDA NETWORK PRACTICAL CLINICAL
TRIALS AND LEARNED A LOT AND
ABOUT THE DIFFERENCE BETWEEN
WHAT Y'ALL FACE AND DOING
RESEARCH AND WHAT I WAS USED TO
IN THE TRADITIONAL SETTING OF
CARDIOVASCULAR DISEASE AND OTHER
I WOULD SAY MORE STRICTLY
MEDICAL PROBLEMS. I THEN WAS
VERY INVOLVED IN STARTUP OF THE
NIH COLLABORATORY AND PCORNET I
REGARD AS PRECURSORS TO THE HEAL
INITIATIVE IN MANY WAYS. I WAS
EXCITED WHEN I READ ON THE HEAL
INITIATIVE THE LAST COUPLE OF
DAYS GETTING READY FOR THIS
MEETING. THIS IDEA OF DOING
PRACTICAL STUDIES ANSWERING
CRITICAL QUESTIONS BRIDGING
RESEARCH AND CLINICAL PRACTICE
TO ME THAT IS THE GREATEST NEED
OUR COUNTRY HAS RIGHT NOW. WE
ARE DARN GOOD IN BASIC SCIENCE,
WE ARE GOOD EARLY PHASE RESEARCH
WE HAVE A LONG WAY TO GO IN THIS
AREA AND GLAD YOU ARE FEELING
THAT NICHE. DURING MY SOJOURN AT
ALPHABET WE START AD NOT FOR
PROFIT IN DAYTON OHIO WHICH DID
STEM TO STERN PEOPLE COMING OFF
ADDICTIVE TREATMENT TO --
SUBSTANCE ABUSE OR SUBSTANCE USE
DISORDER, ALL THE WAY OUT TO
GETTING JOBS AND SURVIVING IN
THE COMMUNITY. AND DEALING WITH
THE LEGAL SYSTEM. I HAD VERY
PRACTICAL IMMERSION END DATE
WITH HIGHEST RATE OF DEATH PER
POPULATION AT THE TIME THAT WE
STARTED. AS I CAME BACK TO THE
FDA AND AS SOME OF YOU MAY HAVE
NOTICED, OPIOID WAS A MAJOR OR
DEAL FOR ME DURING THE
CONFIRMATION PROCESS BECAUSE
THERE IS A HISTORY HERE THAT
EVERYONE IS AWARE OF THAT WE ARE
HAVING TO DEAL WITH. BUT I WAS
GLAD TO SEE STRATEGIES THAT ARE
IN PLAY AND I WAS EXCITED TO
HEAR ABOUT DETAILS OF THE NIH
FRAMEWORK WHICH WE ARE ALL
ADHERING TO IN THIS PRESENTATION
FOR GOOD REASON. GOING TO REF A
COUPLE OF THINGS HERE WHICH
MAYBE IMPORTANT AS YOU LOOK AT
THE HEAL NETWORK AND THINGS THAT
NEED TO BE THAT MAY NEED
PARTICULAR ATTENTION.
REMEMBERING THAT FDA THERE WAS
OLD SAYING IN GOD WE TRUST ALL
OTHERS MUST BRING DATA. NOW
BECAUSE DATA ARE UBIQUITOUS, YOU
CAN GET DATA FOR NOTHING NOW IT
IS IN GOD WE TRUST ALL OTHERS
MUST BRING RELIABLE EVIDENCE. SO
I THINK WE ARE AWASH WITH DATA.
WE ARE SHORT ON RELIABLE
EVIDENCE. THE SECOND THICK IS,
I THINK WE ARE ALL FAMILIAR WITH
THE CONSTRUCT THAT WE HAVE
IDEAS, WE DO CLINICAL TRIALS WE
SORT OUT WHAT WORKS AND WHAT
DOESN'T. WE DEVELOP CLINICAL
PRACTICE GUIDELINES AND GLAD THE
UPDATING IS GOING ON AND I HOPE
AS YOU SUCCEED IN THE HEAL
NETWORK WE'LL HAVE TO HAVE
UPDATES EVERY YEAR BECAUSE THE
EVIDENCE WILL GROW
SUBSTANTIALLY. THEN WE HAVE
QUALITY MEASURES AND THOSE LEAD
TO BETTER OUTCOMES AND IF WE
HAVE A GOOD MEASUREMENT SYSTEM
WE FIND HOLES IN THE PROCESS
THAT NEED TO BE PLUGGED BY MORE
RESEARCH. I WOULD ARGUE IN THIS
FIELD YOU ARE IN SOME WAYS
PIONEERS BECAUSE WHILE NIDA
NETWORK GOES BACK AWAYS IT WAS
TOUGH SLEDDING BECAUSE OF THE
RESOURCES THAT WERE IN SHORT
SUPPLY. AND NOW IS OUR TIME TO
GET THIS RIGHT. THE FINAL
CONCEPT IS TIME ORIENTATION
WHICH IS AN ISSUE I HAD TO TALK
ABOUT A LOT DURING THE
CONFIRMATION, DEALING WITH ACUTE
PAIN IS ONE THING, DEALING WITH
CHRONIC PAIN AND ALL THE ISSUES
THAT ARE INVOLVED, ALSO WITH
ADDICTION IS A WHOLE DIFFERENT
STORY AND WE NEED METHODS AND
APPROACHES AND GLAD TO SEE YOU
ARE WORKING ON THAT. SO QUICKLY,
PREVENTION. I THINK WE ALL AGREE
WE CAN PREVENT PROBLEM IN THE
FIRST PLACE AND IN THAT AREA I
WOULD SINGLE OUT NON-ADDICTIVE
PAIN TREATMENT AND I HAVE TO SAY
ALTHOUGH I KNOW A LOT OF WORK IS
BEING DONE, WE ARE JUST NOT
GETTING WHERE WE NEED TO GO. AND
PART OF IT REALLY HAS TO DO WITH
THE WAY THE PHARMACEUTICAL
INDUSTRY WORKS AND IT IS UPON US
AT THE FDA TO TRY TO FIGURE OUT
HOW TO INCENTIVIZE MORE
INVESTMENT IN THIS AREA BECAUSE
IT IS NOT AN AREA THAT IS THE
INVESTMENT OF CHOICE FOR VENTURE
CAPITALIST OR OTHERS FUNDING
MEDICAL TREATMENTS. I DON'T WANT
TO GIVE SHORT SLIVE TO
BEHAVIORAL TREATMENT, THE MORE
EFFECTIVE ON BEHAVIORAL
TREATMENT THE LESS MEDICINE
WE'LL NEED SO WE ARE FOR THAT
BUT THAT IS NOT PRIMARILY IN THE
FDA JURISDICTION. WE HAVE A
NUMBER OF ISSUES RELATED TO TO
PRESCRIBER EDUCATION, YOU CAN'T
GET MORE PRACTICAL THAN THE
QUESTION, WHAT WORKS, FOR
PRESCRIBER EDUCATION? I HAD
CLOSE RELATIVES IN THE LAST YEAR
WHO GOT 30 DAYS OPIOIDS FROM
MINOR SURGERY, THAT IS DESPITE
ALL THE EFFORTS THAT HAVE GONE
INTO IT. AND EVERY CONGRESS
PERSON I KNOW IS ON OUR CASE
ABOUT BETTER EDUCATION, WE NEED
HELP IN KNOWING WHAT KIND OF
EDUCATION IS GOING TO WORK. I
DON'T KNOW ABOUT THE OTHERS OF
YOU BUT I WILL SAY BEFORE MY
LAST YEAR AT FDA I WAS A BUSY
PRACTITIONER AND I GOT
PROFESSIONAL CLICKING THROUGH
EDUCATIONAL PROGRAMS WHILE
WATCHING BASKETBALL GAMES AND
OTHER THINGS THAT WERE GOING ON.
SO GOING TO BE EFFECTIVE, WE
ACTUALLY NEED EMPIRICAL RESEARCH
TO FIGURE OUT WHAT IS EFFECTIVE.
WE GOT TO FIGURE OUT NON-USE
OPIOIDS, WE'LL HEAR FROM THE FDA
SHORTLY, A SET OF A ALTERNATIVES.
WE NEED TO KNOW WHICH ARE BEST
BECAUSE OUR SOCIETY IS A WASH.
THEN ONE I WONDERED ABOUT A LOT
20 YEARS AGO WAS NETWORK IT IS
REALLY ESSENTIAL NOW, HOW DO WE
DO RESEARCH IN THE ELICIT WORLD?
WE HAVE TEENAGERS NOW WHO CAN
GET ON THE INTERNET AND ORDER A
MAIL ORDER FENTANYL OFTEN
THINKING THEY ARE ORDERING
SOMETHING ELSE. WE DON'T KNOW
MUCH ABOUT HOW THIS WORLD
OPERATES I GOT EXPOSED TO NEW
TERMS IN MY LAST ORIENTATION
WITH DEA LAST WEEK ABOUT THE
ECONOMICS OF DRUG DEALERS WHICH
LIKE A WHOLE FIELD THAT WILL
HAVE TO EVOLVE. THEN THERE IS
HARM REDUCTION, ACCESS TO
NALOXONE, EVERYONE WILL TALK
ABOUT OUT OF ALL OPTIONS WE HAVE
THERE ARE ROAD BLOCKS AN HURDLES
ALONG THE WAY, THE MORE WE KNOW
ABOUT WHAT IS MOST EFFECTIVE AND
WORKS THE BETTER IT WILL BE LIKE
FOR EXAMPLE IF WE MAKE
INJECTIONS AVAILABLE OVER THE
COUNTER WE BY LAW HAVE TO HAVE
EVIDENCE THE PERSON USING IT
ACTUALLY IS LIKELY TO BE ABLE TO
USE IT. CORRECTLY. THE RISK
BENEFIT FRAMEWORK ALLUDED TO IN
DISCUSSION PAPERS I READ ABOUT
HOW DO WE ASSESS RISK TO SOCIETY
FROM PRESCRIPTION GIVEN TO AN
INDIVIDUAL? NATIONAL ACADEMIES
HAS GIVEN US A GOOD FRAMEWORK
FOR THAT, WE ARE WORKING FROM A
DRAFT GUIDANCE NOW BUT WE NEED
EMPIRICAL EVIDENCE HOW TO MAKE
THAT ASSESSMENT FOR THE FUTURE.
THEN THE LAST TWO TREATMENT
RECOVERY SUPPORT. I WOULD SAY WE
NEED A HOST OF VERY PRACTICAL
CLINICAL TRIALS AND I WOULD
POINT TO CLUSTER RANDOMIZATION
IS A METHOD I WOULD HOPE WE USE
A LOT OF, I WAS EXCITED TO HEAR
ABOUT THE MANY, MANY COMMUNITY
NETWORKS THAT CDC IS PUTTING
TOGETHER BUT THEY ARE GOING TO
RIGHT NOW I WOULD SAY FROM MY
EXPERIENCE IN THE NOT FOR PROFIT
THE LAST FEW YEARS THERE ARE
THOUSANDS OF IDEAS AND BELIEFS
BUT NOT MUCH EVIDENCE ABOUT WHAT
COMBINATION OF FACTORS IS GOING
TO BE MOST EFFECTIVE IN THE
COMMUNITY AND THE JOB IN THE
COMMUNITY THAT'S NOT FDA PRIMARY
BUT THE BEAR JOB IS DONE EASIER
OUR JOB WOULD BE IN GIVEN WHAT I
HAVE LEARNED THE FIRST AGO WEEKS
HERE AT FDA WELCOME MAKING OUR
JOB EASIER. SO WITH THAT, I WILL
CLOSE AND LOOK FORWARD TO THE
DISCUSSION.
>> THANKS VERY MUCH FOR THOSE
OBSERVATIONS AND WE ALL AIM TO
MAKE YOUR JOB MUCH EASIER
INDEED. SO FINALLY WE WOULD LIKE
TO HEAR FROM DR. DELPHIN RITTMON
PLEASE.
>> THANK YOU SO MUCH. GOOD
AFTERNOON, EVERYONE. I JUST WANT
TO SAY SPECIAL THANK YOU TO THE
NIH TEAM FOR INVITATION TO BE
HERE AND FOR CONVENING US. FOR
THIS REALLY IMPORTANT
DISCUSSION. AND I DO HAVE TO
SAY I'M DELIGHTED TO BE JOINED
BY MY COLLEAGUES AT CDC AND FDA
AS WELL. AS PART OF THE HEAL
INITIATIVE SAMSA IS ENGAGED WITH
NIH AND NIDA FOR THE LAST THREE
YEARS. SO WE SO APPRECIATE THIS
COLLABORATION WITH NIH AND NIDA
AND REALLY THE FULL CONSORTIUM
OF GRANTEES FROM OHIO, KENTUCKY,
NEW YORK, MASSACHUSETTS, AS WELL
AS THE DATA COORDINATING CENTER
AND NIDA. SO I WANT TO THANK ALL
OF PARTNERS ON THIS PROJECT WHO
HAVE WORKED ON THIS STUDY DURING
A PARTICULARLY DIFFICULT TIME.
WE KNOW CONDUCTING RESEARCH MANY
THE MIDST OF A PANDEMIC HAS
CHALLENGES SO SPECIAL THANK YOU
ALSO TO ALL THE PARTNERS. WE
KNOW THE GOAL OF THE HEAL
COMMUNITY STUDIES IS ESSENTIALLY
TO TEST INTEGRATED SET OF
EVIDENCE BASED PRACTICES WITH
THE AIM OF REDUCING OPIOID
RELATED DEATH AND HOPEFULLY THAT
IS THE GOAL. THIS IS
PARTICULARLY IMPORTANT TO SAMSA
AS RESEARCH GENERATED FROM THIS
PROJECT, ULTIMATELY WILL HELP TO
INFORM EVIDENCE BASED PRACTICES
AND INTERVENTIONS THAT WE
ULTIMATELY IMPLEMENT AND EVEN
SCALE UP. SO AS A SERVICE
DELIVERY AGENCY, SAMSA
APPRECIATES AND USES THE
RESEARCH THAT IS DEVELOPED
THROUGH NIH AGAIN TO AMPLIFY
EVIDENCE BASED PRACTICES FOR
IMPLEMENTATION. IN ADDITION TO
THE HEAL COMMUNITY
COLLABORATIONS, WITH SAMSA I
ALSO WANT TO HIGHLIGHT SOME OF
OUR PRIORITIES AND NEW
INITIATIVES RELATED TO
ADDRESSING THE OPIOID EPIDEMIC.
AND OVERDOSE CONCERNS. THAT MAY
BE HELPFUL FOR FOLKS TO HEAR
ABOUT AS WELL. SO ESSENTIALLY TO
FRAME SOME OF SAMSA PRIORITIES
AS WE THINK ABOUT ADDRESSING
OPIOID AND OVERDOSE MORE
GENERALLY, I WILL BRIEFLY
REFERENCE THE HHS OVERDOSE
PREVENTION STRATEGY SECRETARY
BECERRA RELEASED LAST FALL. THIS
STRATEGY WAS DESIGNED TO
INCREASE ACCESS TO REALLY A FULL
RANGE OF SERVICES FOR
INDIVIDUALS THAT USE SUBSTANCES,
THAT ULTIMATELY CAUSE OVERDOSE.
I HAVE TO SAY IT WAS SUCH A
VALUABLE COLLABORATION ACROSS
HHS IN TERMS OF MULTIPLE
AGENCIES US WORKING TOGETHER AND
THINKING STRATEGIZING TOGETHER
AROUND HOW WE CAN ADDRESS THE
TRENDS WE ARE SEEING AS RELATES
TO OVERDOSE. THE OVERDOSE
PREVENTION STRATEGY PRIORITIZES
FOUR KEY TARGET AREAS. SO
PRIMARY PREVENTION, HARM
REDUCTION, EVIDENCE BASED
TREATMENT, AND RECOVERY SUPPORT.
ABSOLUTELY I WOULD SAY REFLECTS
THE BIDEN HARRIS ADMINISTRATION
OF MAXIMIZING HEALTH EQUITY.
ALSO FOR UNDERSERVED
POPULATIONS. ALSO USING THE BEST
AVAILABLE DATA AND EVIDENCE TO
INFORM POLICY AND ACTION,
INTEGRATION OF SUBSTANCE USE
DISORDER INTO OTHER TYPES OF
HEALTHCARE AND SOCIAL SERVICES,
AND AS WE HAVE HEARD REDUCING
STIGMA IS A KEY PART OF STRATEGY
AS WELL. SO I WANT TO TALK ABOUT
TWO IMPORTANT POLICY CHANGES
SAMSA PUT IN PLACE. RELATED TO
THIS. FROM A PREVENTION
PERSPECTIVE. IN APRIL LAST YEAR
WE ANNOUNCED AND DR. HOURY
MENTIONED THIS, THAT OUR GRANT
FUNDS COULD BE USED TO PURCHASE
FENTANYL TEST STRIPS. THERE'S
QUITE A BIT OF ADVOCACY AROUND
THIS SO GRANT FUNDS CAN BE USED
TO PURCHASE FENTANYL TEST
STRIPS. ULTIMATELY THE GOAL OF
THIS POLICY IS TO REDUCE
DRAMATIC SPIKE IN DEATHS THAT WE
HAVE LARGELY DRIVEN BY THE
SYNTHETIC OPIOID INCLUDING
ELICITLY MANUFACTURED FENTANYL.
SAMHSA, THIS POLICY CHANGE
APPLIES TO ALL FEDERAL GRANTS AS
LODGE AS PURCHASE OF THE
FENTANYL TEST STRIPS IS
CONSISTENT WITH PURCHASE OF THE
PROGRAM. -- PURPOSE OF THE
PROGRAM. LAST YEAR ALSO SAMHSA
WITH HHS ANNOUNCED THAT WE WOULD
EXEMPT ELIGIBLE PROVIDERS FOR
THE EIGHT HOUR WAIVERRED
TRAINING TO TREAT UP TO 30
PATIENTS WITH BUPRENORPHINE. WE
FOUND PROVIDERS INCLUDING
PHYSICIAN, PHYSICIAN SENTEDS
NURSE PRACTICERS, CLINICAL NURSE
PRACTITIONERS, CERTIFIED NURSE
ANESTHESIOLOGISTS AND MIDWIVES
HAVE TO NOTIFY GOVERNMENT OF
THEIR INTENT TO PRESCRIBE
BUPRENORPHINE BUT DON'T HAVE TO
COMPLETE THE TRAINING WE HAVE
BEEN HEARING AND ADVOCATING THAT
THAT IS A BARRIER. SO THIS
POLICY HELPS TO AND GOAL IS TO
REVIEWS BARRIERS FOR PRESCRIBING
BUPRENORPHINE TO INDIVIDUALS
WITH OPIOID USE DISORDER AND
EXPAND THE NUMBER OF PROVIDERS
THAT ARE PRESCRIBING. WE HAVE
SEEN THAT, WE HAVE SEEN OVER
10,000 ADDITIONAL PROVIDERS THAT
ARE NOW PRESCRIBING SINCE THIS
WAS PUT IN PLACE. KEY INITIATIVE
TO TALK ABOUT IS OUR WORK
RELATED TO HARM REDUCTION, HARM
REDUCTION PROGRAM AND DR. HOURY
MENTIONED THIS AS WELL. AS YOU
KNOW WE RECENTLY AND WE ARE
THRILLED TO RELEASE NEW FUNDING
OPPORTUNITY HARM REDUCTION GRANT
OPPORTUNITY, THAT'S $30 MILLION
OVER THREE YEARS, $10 MILLION A
YEAR. WE ANTICIPATE MAKING 25
AWARDS. SO THESE RESOURCES CAN
BE USED TO PURCHASE AND SUPPORT
HARM REDUCTION EFFORTS COMMUNE
-- AT THE COMMUNITY LEVEL TO
INCLUDE SERVICE PROGRAMS AND
OTHER HARM REDUCTION SERVICES.
IN TERMS OF SAMHSA FOCUS ON
EVIDENCE BASED PRACTICES I WANT
TO HIGH LIGHT OUR EVIDENCE BASED
PRACTICE RESOURCE CENTER. THE
21ST CENTURY CURES ACT.
ESSENTIALLY DIRECTED SAMHSA TO
PROMOTE ACCESSIBLE RELIABLE
VALID INFORMATION ON EVIDENCE
BASED PROGRAMS AND PRACTICES AND
THE SHARE INFORMATION ON
STRENGTH OF THE EVIDENCE AID
SOCIALIATED WITH THE PROGRAMS
AND PRACTICES. SO WE HAVE
DEVELOPED THE EVIDENCE BASED
PRACTICE RESOURCE CENTER, WHICH
ESSENTIALLY PROVIDES BEHAVIORAL
HEALTH INFORMATION ON EVIDENCE
BASED PROGRAMS AND PRACTICES, AT
THE STATE LOCAL AND FOR
COMMUNITIES NON-PROFIT ENTITIES
AND OTHER ENTITIES AS WELL SO
THAT IS A RESOURCE THAT
AVAILABLE. LASTLY I WANT TO
MENTION A KEY INITIATIVE AT
SAMHSA THAT IS INFORMED -- THAT
IS ALSO PART OF THE OVERDOSE
PREVENTION STRATEGY AS RELATES
TO RECOVERY. WE RECENT WILL I
ANNOUNCED OUR OFFICE RECOVERY,
AND GOAL OF THIS OFFICE AND WE
ARE THRILLED ABOUT THIS, THE
GOAL IS TO ENSURE THAT RECOVERY
IS PART OF THE GUIDING
PRINCIPLES OF SAMHSA'S POLICIES,
PROGRAMS, SERVICES, AND TO
ENSURE ALSO INDIVIDUALS IN
RECOVERY ARE AND LIVED
EXPERIENCE ARE PART OF OUR
STAKEHOLDER AND AGENCY
ACTIVITIES. SO IN CONCLUSION I
WANT TO END BY SAYING AGAIN
THANK YOU TO NIH FOR INVITING
SAMHSA TO BE PART OF TODAY'S
HEAL INVESTIGATOR MEETING. AND
SAY WE SO LOOK FORWARD TO
CONTINUED COLLABORATION WITH
BOTH FEDERAL AND NON-FEDERAL
PARTNERS AS WE WORK TO REDUCE
OVERDOSE DEATH. SO THANK YOU.
>> WELL, THANK YOU AND I MUST
SAY THE THREE OF YOU HAVE DONE A
SUPERB JOB OF OUTLINING MANY KEY
ISSUES. I DO HAVE A SERIES OF
QUESTIONS TO GENERATE BIT MORE
DISCUSSION WHICH ARE DERIVED
FROM COMMENTS MADE BY THE
INVESTIGATORS DURING THE THE
COURSE OF THE MEETING AND YOU
ALL MIGHT WANT TO TURN ON YOUR
CHAT FUNCTION BECAUSE THERE ARE
MORE QUESTIONS COMING AS WE ARE
SPEAKING AND SO YOU MAY WANT TO
SEE THOSE AS WELL AND HOPEFULLY
WE CAN GET SOME OF THOSE AS
WELL. SO MAYBE JUST TO TRY TO
PICK SOME THINGS CERTAINLY
ALLUDED TO BUT PERHAPS YOU CAN
ELABORATE A LITTLE BIT MORE
ABOUT, SO I GUESS THIS ONE
MOSTLY FOR DEB AND ROB BUT
MIRIAM FEEL FREE. WE ALL KNOW
ADOLESCENTS AND YOUNG ADULTHOOD
ARE KEY PERIODS FOR INTERVENTION
WHEN INDIVIDUALS HAVE SUBSTANCE
USE DISORDERS BUT TREATMENT
OPTIONS AND UPTAKE ARE LIMITED
FOR YOUTH. YOUTH. YOUTH. I APPRECIATE
UNDERSTANDING YOUR PERSPECTIVES
WHAT WE CAN DO TO CHANGE THAT.
FOR EXAMPLE, MORE STUDIES OF
DRUG SAFETY IN ADOLESCENCE? NEED
PUBLISHED GUIDELINES FOR
TREATING OPIOID USE DISORDER IN
ADOLESCENCE? WHAT ARE SOME OF
THE THINGS YOU THINK ARE
REQUIRED HERE?
>> COULDN'T BE MORE TIMELY,
THERE IS A REPORT I THINK IN
JAMA TODAY ABOUT A VERY
SUBSTANTIAL INCREASE IN OVERDOSE
DEATH AND TEENAGERS. AS I
MENTION IN MY INTERACTIONS WITH
THE DA I LEARN MORE ABOUT THE
WAY THIS IS HAPPENING WHICH I
THINK WE SHOULD BE VERY
CONCERNED ABOUT. BOTTOM LINE IS,
WE NEED EVIDENCE. THE NETWORK I
HOPE WILL LAUNCH STUDIES
SPECIFICALLY ORIENTED TO THE
QUESTIONS ABOUT AT LESS SENTS.
THE FDA IS LIMITED BY THE DATA
THAT IT HAS IN TERMS OF THINGS
LIKE DRUG LABELS, ET CETERA. BUT
I WOULD ALSO MENTION I THINK YOU
ARE GOING TO FIND A LOT OF PULL
THROUGH BY FDA NOW ENCOURAGING
PEOPLE TO DEVELOP EVIDENCE
AROUND USE OF PARTICULAR
PRODUCTS. IN ADDITION TO THAT I
THINK MY TWO COLLEAGUES HAVE
MAJOR ROLES TO PLAY BECAUSE A
LOT OF THIS IS NOT BIOLOGICAL
ISSUE IT IS AN ISSUE OF SOCIAL
CIRCUMSTANCES PEOPLE ARE IN.
>> INDEED. DEB, WOULD YOU LIKE
TO ADD ON, PLEASE?
>> YES, I WOULD SAY ROB TO THAT
PERFECTLY, THANK YOU. I THINK
FOR ME IT IS ABOUT PRIMARY
PREVENTION ASPECT, NO JUST
FOCUSING ON THE TREATMENT OF THE
YOUTH BUT HOW WE LOOK AT THINGS
LIKE ADVERSE CHILDHOOD
EXPERIENCES SO THEY CAN PREVENT
THIS FROM HAPPENING IN THE FIRST
PLACE AN THOSE WHO EXPERIENCED
HOW WE MITIGATE CONSEQUENCES
BECAUSE WE KNOW THERE'S THAT
LINK BETWEEN MULTIPLE ACES AND
SUBSTANCE USE PROBLEMS AND
MENTAL HEALTH PROBLEMS SO REALLY
LOOKING HOW WE CAN INTERVENE IS
HELPFUL. WE ALLOWED A LOT OF
OVERDOSE GRANT RECIPIENTS TO
REALLY FOCUS ON ACES AND MORE
THAN HALF CURRENTLY ARE. I THINK
THINGS LIKE EVEN DURING THE
PANDEMIC WE HAVE SEEN
STRENGTHENING FAMILIES BEING
IMPLEMENTED VIRTUALLY. WITH KIDS
WHO REALLY BUILD THAT RESILIENCE
BUILD THAT CONNECTEDNESS,
LOOKING AT MODELS LIKE
COMMUNITIES THAT CARE AS WELL
AND EMPOWERING YOUTH TO LOOK AT
WHAT INTERVENTIONS AND
STRATEGIES DO THEY WANT TO
IMPLEMENT IN THEIR COMMUNITY.
THEN MAKING SURE THAT EVEN
THINGS LIKE STRENGTHENING SAFE
STABLE NURTURING RELATIONSHIPS
BETWEEN A CARING ADULT AND YOUTH
OR CHILD REALLY BUILD THAT AND
WE HAVE A TECHNICAL PACKAGE OR
SERIES OF STRATEGIES ON OUR
WEBSITE, REALLY FOCUSED ON
PREVENTING ACES AND ALL FOCUS ON
THINGS LIKE SOCIAL EMOTIONAL
LEARNING BUT ALSO THINGS LIKE
SOCIAL DETERMINANTS OF HEALTH.
POLICIES AROUND EARNED INCOME
TAX, CHILD CARE STRATEGIES TO
LAY THOSE FOUNDATIONS, SO I
THINK TREATMENT IS IMPORTANT
LINKAGE TO CARE BUT CERTAINLY
PRIMARY PREVENTION IS IN MY MIND
ALWAYS IMPORTANT TO KEEP AT
TABLE. THANKS.
>> THANK YOU. MIRIAM, ANYTHING
TO ADD ON THIS TOPIC?
>> YEAH. I AGREE, THE PRIMARY
PREVENTION PIECE IS SO
IMPORTANT. I SO APPRECIATED WHEN
THROUGH FOR EXAMPLE OUR
STRATEGIC PREVENTION FRAMEWORK
COMMUNITIES TO INCLUDE SCHOOLS
AND STUDENTS WITHIN SCHOOLS
DEVELOP PREVENTION MESSAGING.
AROUND SUBSTANCE USE. THOSE ARE
OFTEN THE MOST POWERFUL
STRATEGIES AND TOOLS AROUND
PREVENTION. I REMEMBER ONE
CAMPAIGN THAT SO STUCK WITH ME
OVER THE YEARS AROUND --
REDUCING VAPING WITHIN SCHOOLS
SO THE KIDS WOULD STAND AT THE
DOOR AS STUDENTS BEING LED OUT
AND GIVE OUT BUBBLES AND THE
BUBBLES WOULD SAY BLOW BUBBLES
NOT SMOKE. SO THINGS LIKE THAT,
CATCHY BUT THEY MAKE A
DIFFERENCE. THE OTHER THING
IMPORTANT AS WELL IS TRAINING
AND EDUCATION OF TEACHERS AND
SCHOOL PERSONNEL TO IDENTIFY
RECOGNIZE WHEN A STUDENT IS
STRUGGLING WHETHER FROM MENTAL
HEALTH OR SUBSTANCE USE
CHALLENGES SO MENTAL HEALTH
AWARENESS TRAINING CAN TRAIN
PERSONNEL TO IDENTIFY WHEN A
STUDENT IS STRUGGLING PROJECT
AWARE GRANT SAME THING, TRAINS
TEACHERS OTHER SCHOOL PERSONNEL
AND WORKS TO LINK STUDENTS TO
SERVICES AND SUPPORTS. AND
ULTIMATELY IF A STUDENT IS
CONNECTED EARLY THAT CAN HELP IN
TERMS OF OVERALL TRAJECTORY OF
WHAT THEY ARE EXPERIENCING IN
TERMS OF GETTING HELP. SO JUST A
FEW AREAS THAT CAN MAKE AN
IMPACT AND THAT ARE IMPORTANT.
>> THANK YOU. WHILE YOU HAVE THE
THE MICROPHONE LET ME START WITH
YOU, MIRIAM, BECAUSE -- AND YOU
HAVE ALLUDED TO THIS ALREADY.
THE INTERSECTION BETWEEN YEPED
YOU INVOLVE OVERDOSE AMONG YOUTH
AND MENTAL HEALTH PROBLEMS. WE
KNOW COMBINATION OF AD VERSION
CHILDHOOD EXPERIENCES TRAUMA,
ANXIETY DEPRESSION, NOT BEING IN
SCHOOL, TRAINING PROGRAM, ALL
THESE THINGS FACTOR IN. HOW DOES
THIS INFORM THE PROGRAM AND
POLICIES THAT YOU ARE ENGAGED
WITH AT SAMHSA?
>> ALL OF THIS INFORMS WORK ONE
THING WE APPRECIATE HEARING FROM
STAKEHOLDERS AND WE HAVE A
NUMBER OF LIVELY ADVISORY
COMMITTEES BUT ALSO REGULARLY
WILL HOLD ROUND TABLE
DISCUSSIONS OR HOURS WITH
VARIOUS STAKEHOLDER GROUPS AND
SOME OF THE GOAL IS TO REALLY BE
ABLE TO GET THAT INPUT TO THEN
HAVE IN A ADDITION TO WHAT WE
SEE FROM RESEARCH AND SEEING
FROM OTHER GRANT PROGRAMS, HAVE
ALL OF THAT INFORM PROGRAMS AND
INITIATIVES WE PUT IN PLACE.
ULTIMATELY THAT HEALTHCARE
INTEGRATION PIECE, LOOKING AT
INCORPORATING THROUGH WHEN WE
CAN MENTAL HEALTH AND STONNS
USE, APPROACHES STRATEGIES.
TRAINING PEOPLE NOT ONLY TO
IDENTIFY MENTAL HEALTH
CHALLENGES BUT SIGNS AND
SYMPTOMS A STUDENT MIGHT BE
USING SUBSTANCES, CAN ALSO HELP
WITH CONNECTING A STUDENT TO
SERVICES AN SUPPORTS.
>> DIDN'T ANYTHING TO ADD IN
THIS TOPIC?
>> MIRIAM COVERED, I THINK THE
ONE THING I WOULD ADD IS
IMPORTANCE OF TRAUMA INFORMED
CARE BECAUSE THAT IS REALLY
IMPORTANT AS IF A CHILD IS
EXPERIENCING DRUG USE IN THE
HOME, THEY MIGHT NOT HAVE DONE
THEIR HOME WORK, MIGHT HAVE THE
SAME SET OF CLOTHES ON SO MAKING
SURE THERE IS A HANDLE WITH CARE
PROGRAM AND PANELISTS ARE
FAMILIAR WITH HAVING HOLISTIC
APPROACH TO CHILDREN AND YOUTH
AND THESE CIRCUMSTANCES.
>> THANK YOU. LET'S SWITCH GEARS
ROB TO ASK YOU THE FOLLOWING.
AND ALL OF YOU MENTIONED
STIGMATIZATION THAT OCCURS.
GIVEN LONG STAND ACCESS ISSUES
AND STIGMATIZATION, IS FDA
CONSIDERING ALTERNATIVE MODELS
FOR PRESCRIBING MEDICATIONS FOR
YEPED YOU USE DISORDER FOR
EXAMPLE INCREASE FLEXIBILITY
WITH TICK HOME METHADONE OFFICE
OR PHARMACY BASED DISPENSAL
MOBILE UNITS OR ADDING
BUPRENORPHINE TO LIST OF
ESSENTIAL MEDICATIONS AMONG
OTHER THINGS. SHORT ANSWER YES,
LONG ANSWER IS MAN THIS IS
COMPLICATED BECAUSE IT IS AT THE
INTERFACE OF FDA AUTHORITY AND
PRACTICE OF HEALTHCARE SO
EVERYBODY IN THIS PANEL HAS
SOMETHING TO SAY. BUT I WANT TO
COME BACK TO WHAT I SAID AT THE
BEGINNING. IF EVIDENCE IS
GENERATED AHEAD OF TIME IT IS
HARD FOR PEOPLE THAT BELIEVE OR
DON'T BELIEVE TO ARGUE ABOUT.
GENERAL THING THAT I HAVE
RELEARNED IN 2022 THAT I LEARNED
IN 2016, THE AMOUNT OF HEAT
EMITTED AROUND AN FDA DECISION
IS PROPORTIONAL TO QUALITY OF
EVIDENCE IF YOU GUYS BRING THE
EVIDENCE IN ON HEAL, THEN WE
WILL KNOW WHICH OF THESE
DIFFERENT ALTERNATIVE APPROACH
ARE LIKELY TO WORK IN THE FACE
OF FOR EXAMPLE, ALTERNATIVE
PRESCRIBERS WHERE THE MEDICAL
SOCIETIES WILL GO TO EXTREME
LENGTHS TO BLOCK THAT. HOME
METHADONE THERE'S A SET OF
PEOPLE OPPOSED TO THAT FOR A
VARIETY OF REASONS BUT SHOWS IT
WORKS AND BENEFITS OUTWEIGH THE
RISKS, IT GETS EASIER SO THIS IS
A TREMENDOUS PLACE FOR THE HEAL
INITIATIVE TO PLAY A ROLE. WE
WILL ENCOURAGE RESEARCH WITH
EVERYTHING WE CAN POSSIBLY DO AT
FDA.
>> DEB, YOU INDICATED CDC IS IN
THE PROCESS OF UPDATING OPIOID
PRESCRIBING GUIDELINES. CAN WE
GET A SNEAK PREVIEW, WHAT ARE
THE CHANGES UNDER CONSIDERATION?
>> I CAN GIVE YOU SNEAK PREVIEW
WHAT IT WAS GOING INTO PUBLIC
COMMENT BECAUSE CERTAINLY WE
WILL SEE WHAT THEMES AND
SUGGESTIONS THAT COME OUT OF
COMMENTS WE RECEIVE. WE LOOK AT
BROADENING FOCUS PAST CHRONIC
PAIN TO ALSO INCLUDE ACUTE AND
SUB ACUTE PAIN. AND BROADEN TO
MORE PROVIDERS AND OUTPATIENT
SETTINGS. ONE THING I THOUGHT
WAS HELPFUL AS CLINICIAN IS MUCH
MORE SPECIFIC INFORMATION ON
TYPES AND MOVES OF NON-OPIOID
MEDICATIONS AND NON-MEDICATIONS
FOR DIFFERENT TYPES OF ACUTE
CHRONIC PAIN AND MORE
INFORMATION ON TAPERING AND US
CONTINUATION BECAUSE THAT WASN'T
AS MUCH PRESENT IN THE FINAL --
OR IN THE FIRST GUIDELINES. THEN
BECAUSE OUR GUIDELINES TEND TO
BE LONG, WE WANT TO CHANGE SOME
OF THE FORMATTING INCLUDING
OPENING BOX CLEARLY SET OUT UP
FRONT WHAT THIS IS AND IS NOT.
TO REALLY ALLOW US TO PROVIDE
THAT MORE SPECIFIC GUIDANCE
AROUND WHAT THIS IS AND IS NOT
AND WE PROVIDE RECOMMENDATIONS
TO AVOID MISAPPLICATION.
>> GIVE MY COLLEAGUES A HEADS UP
WE ARE GETTING CLOSE TO TIME, IF
YOU WOULD REVIEW THE CHAT BOX
AND FIND YOUR FAVORITE QUESTION
TO ANSWER BUT I WILL IMPOSE UPON
YOU MIRIAM TO ASK IF YOU CAN
SPEAK TO ISSUES RELATED TO
STIGMATIZATION. WE ALL ALLUDED
TO IT, WE KNOW IT IS IMPORTANT
PROBLEM. WHAT RESEARCH IS NEEDED
TO BETTER INFORM THE APPROACHES
GOING FORWARD?
>> I SO APPRECIATE THAT
QUESTION. IT IS SUCH AN
IMPORTANT AREA WHERE WE ARE MORE
RESEARCH IS NEEDED HERE. WE
OFTEN SAY WE KNOW STIGMA IS SUCH
A BARRIER TO CARE AND STIGMA CAN
BE A BARRIER TO HELP SEEKING BUT
ALSO IN TERMS PRESCRIBING
PRACTICES. TO THE EXTENT WE ARE
ABLE TO ENHANCE PROVIDER
EDUCATION AND INCREASE OF VALUE
OF MEDICATION ASSISTED TREATMENT
THAT CAN REDUCE MISINFORMATION
OR MISUNDERSTANDING AROUND WHAT
MAT IS OR ISN'T AND WILL
POTENTIALLY REDUCE POTENTIAL
STIGMA. THERE IS A GOOD BIT OF
STIGMA IN THE FIELD THAT MET IS
REPLACING ONE MEDICATION OR ONE
DRIVE WITH ANOTHER SO I THINK
BREAKING DOWN STIGMA AND
CHANGING PEOPLE'S PERCEPTIONS
AND HOW THE CHANGE PERCEPTIONS
ULTIMATELY FLOW INTO PRACTICE
AND BEHAVIOR. AGAIN WHETHER IT
BE HELP SEEKING OR A PROVIDER
BEHAVIORS OR EVEN COMMUNITY OR
FAMILY BEHAVIORS ABOUT SUBSTANCE
USE AND TREATMENT. THIS IS AN
AREA JUST THAT SO MUCH MORE
RESEARCH IS NEEDED TO BETTER
UNDERSTAND HOW WE STIGMA BLAST
AND HOW WE ULTIMATELY CHANGE
PRACTICE ALONG WITH BELIEFS.
>> THANK YOU SO MUCH. I DON'T
THINK IF DEB OR ROB YOU HAD A
CHANCE TO FIND A FAVORITE
QUESTION YOU WOULD LIKE TO
ADDRESS, THERE ARE MANY, AND WE
WON'T GET TO ALL BUT DEB HAVE
YOU FOUND ONE YOU WOULD LIKE TO
SPEAK TO?
>> LOOKS LIKE ALMOST ALL OF OUR
DIRECTED TO ROB SO I WILL LET
HIM PICK ONE.
>> THERE ARE SOME GREAT
QUESTIONS, SO MAYBE WHAT I WILL
DO IS QUICKLY SAY OBJECT
QUESTION OF HOW DO YOU GET
ACCELERATED PATHWAY THERE IS A
NEW GUIDANCE OUT, A DRAFT
GUIDANCE ON ACUTE PAIN,
DIRECTIONS IN THERE ABOUT WHO TO
CONTACT, I WOULD URGE YOU TO DO
IT, THERE'S GOING TO BE
ENCOURAGEMENT AT FDA TO FIND BUT
YOU STILL HAVE TO MAKE THE U
CASE TO MAKE THE CRITERIA BUT
ENCOURAGEMENT TO MEET CRITERIA.
METHAMPHETAMINES IS NOT JUST
OPIOIDS. WE ARE SEEING ABILITY
TO MASS PRODUCE VERY HIGH
POTENCY METHAMPHETAMINES NOW IN
THESE CHEMICAL FACTORIES IS A
HUGE ISSUE. THE SECOND ONE JOBS
TO MENTION, I DON'T KNOW THE
ANSWER. BUT WE HAVE TO SUMMON
THE ISSUE WITH TOBACCO. THE WAY
THE LAW WORKS STATUTE SAYS
ASSESS RISKS AND BENEFITS OF THE
PERSON THE INTENDED USE FOR
PERSON FOR WHOM THE DRUG IS
PRESCRIBED. WITH OPIOIDS WE HAVE
GOT THAT EQUATION PLUS WHAT DOES
IT MEAN WITH DIVERSION AND OTHER
THINGS THAT HAPPEN TO THE REST
OF SOCIETY. WHEN A NEW PRODUCT
COMES ALONG WE ARE GOING TO HAVE
TO MAKE THAT ASSESSMENT IF THE
DRAFT GUIDANCE GOES THROUGH
WHICH I'M VERY MUCH IN FAVOR OF
BUT IT IS A RESEARCH QUESTION AS
TO HOW YOU GET THE BEST
ESTIMATE. AND LET ME TELL YOU WE
HAVE EXACTLY THE SAME ISSUE BE
TOBACCO PRODUCTS WHERE WE HAVE
TO MAKE THAT SAME JUDGMENT. FOR
THE PROXIMAL PART WE HAVE AN
EMPIRICAL EXERCISE WHERE WE CAN
GET THE ANSWER. FOR SOCIETAL
EFFECTS OVER TIME WE NEED A WAY
TO ESTIMATE AND GET BETTER AT
IT.
>> THANK YOU FOR THAT. SO I WILL
JUST COMMENT, DR. HAGERTY POINTS
OUT BUBBLES MAYBE GOOD BUT
ANOTHER STRATEGY THAT CONNECTS
KIDS WITH THEIR FUTURES IS
POSITIVE GREETING AT THE DOOR --
WITH TEACHERS IS POSITIVE
GREETING AT THE DOOR. SO
CORRECT.
>> YES.
>> NO QUESTION ABOUT THAT. I
DON'T SPEAK FROM PERSONAL
EXPERIENCE, I LIVE VICARIOUSLY,
MY WIFE OF NUMBER OF YEARS IS A
ELEMENTARY SCHOOLTEACHER SO I
CAN TELL YOU I HAVE OBSERVED
THIS FIRSTHAND. ANY LAST WORDS
THAT ANY OF YOU WOULD LIKE TO
MAKE BECAUSE I KNOW WE ARE JUST
ABOUT AT TIME AND I'M SENSITIVE
TO YOUR SCHEDULES. BUT IF THERE
ARE ANY FINAL WORDS CERTAINLY
ARE WELCOME AT THIS POINT.
>> I WILL SAY THIS IS GOD'S
WORK. WE ARE INDEBTED TO THOSE
OF YOU ON THE NETWORK DOING THE
WORK AND WE'LL DO EVERYTHING WE
CAN TO SUPPORT AT THE FDA.
>> THANK YOU SO MUCH.
>> I WOULD LIKE TO ADD,
CERTAINLY DON'T HESITATE TO
REACH OUT IF FOLKS NEED ANY
RESOURCE, RELATED TO ANY OF OUR
PROGRAMS OR SERVICES OR SUPPORTS
OR CERTAINLY CHECK OUT OUR
WEBSITE OR EVEN REACH OUT TO US
DIRECTLY. DEFINITELY THINK OF US
AS RESOURCE AND PARTNER IN THE
WORK YES DOING TOGETHER. THANK
YOU.
>> THANK YOU.
>> I WOULD SAY DITTO. WE LEARN
FROM ALL OF YOU ON THE GROUND,
IN PARTICULAR WE SEE THIS
EVOLVING EPIDEMIC, PLEASE REACH
OUT AND LET US KNOW HOW WE CAN
SUPPORT YOU AND WORK TOGETHER.
>> THANK YOU TO MY COLLEAGUES,
DEB, ROB AND MIRIAM, I REALLY
THANK YOU SO MUCH FOR SPENDING
TIME WITH US TODAY AND WITH OUR
RESEARCH COMMUNITY AND PATIENT
GROUPS. THANK YOU AND WE ARE
GOING TO GIVE YOU BACK TWO
MINUTES OF YOUR LIVES. THANKS
ALL VERY, VERY MUCH. I WILL TURN
THIS BACK TO DR. BAKER.
>> THANK YOU VERY MUCH, DR.
TABAK, THANK YOU TO THE
PANELISTS AND ALL OF YOU WHO
SUBMITTED REALLY GOOD QUESTIONS
IN THE CHAT AND IN ADVANCE OF
THE MEETING. IT IS REALLY
IMPRESSIVE ALL THE DIFFERENT
ACTIVITIES UNDERWAY AND ALL
THESE AGENCIES. AND WE REALLY
ARE PLEASED TO BE IN A POSITION
TO GENERATE THAT EVIDENCE TO
INFORM THE CHANGES NEEDED
CHANGES TO PRACTICE AND SHARING
OF NEW WAYS OF APPROACHING THE
PAIN AND OPIOID ADDITION CRISIS.
SO THANK YOU VERY MUCH. DR.
TABAK, WOULD YOU LIKE TO SAY
SOME FINAL WORDS? BEFORE WE GET
TO THE END OF THE MEETING?
>> I THINK THAT IS PROBABLY
APPROPRIATE GIVEN THE TIME. I
KNOW THAT IT HAS BEEN A VERY
INTENSE COUPLE OF DAYS FOR ALL
OUR PARTICIPANTS. BUT I DO HOPE
EVERYBODY AGREES THAT THE
MEETING HAS BEEN AN OUTSTANDING
SHOWCASE OF HOW HARD EVERYBODY
IS WORKING ON THESE IMPORTANT
PROBLEMS AND TOWARDS ADVANCING
THE HEAL MISSION. WE ARE MAKING
REALLY GOOD PROGRESS BUT AS YOU
ALL UNDERSTAND, THERE'S SO MUCH
MORE TO BE DONE TO ADDRESS BOTH
PAIN AND OPIOID CRISIS. THE
PANDEMIC CONTINUES TO THROW US
CHALLENGES, BUT THIS IS JUST
SUCH A REMARKABLY RESOURCEFUL
COMMUNITY, YOU HAVE SHOWN TIME
AND AGAIN YOU CAN MEET THE
MOMENT AND ARE READY FOR
WHATEVER COMES NEXT. I HOPE YOU
APPRECIATE THE STRUCTURE AND THE
TOPICS OF THE MEETING THIS YEAR
REFLECT THE PRIORITIES
MEANINGFUL PARTICIPANTS OF
INDIVIDUALS WITH LIVED
EXPERIENCE. YOU HEARD AN EYE
OPENING CONVERSATION WITH THE
HEAL COMMUNITY PARTNER COMMITTEE
AND NIH LEADERS AND WE WERE VERY
FORTUNATE TO HAVE INSIGHTFUL
CANDID SESSION BETWEEN -- I
APOLOGIZE IF I MISPRONOUNCE THE
NAME, (INDISCERNIBLE) AND NOVA
VOLKOW ABOUT REALITIES OF LIVING
WITH PAIN AND ADDICTION IN THE
UNITED STATES. THE SECOND THING
OF COURSE IS TEAM WORK. THIS
YEAR'S MEETING WAS NOTABLE FOR
THE INTEGRATED APPROACH TO
TALKING ABOUT THE SCIENCE THAT
WE ARE DOING. PATIENTS AND
DISEASES DON'T FALL INTO MEAT
BUCKETS SO AS A RESEARCH
COMMUNITY, WE NEED TO CONTINUE
TO LOOK AT THE BIG PICTURE AND
NOT AN INDIVIDUAL INSTITUTES AND
CENTERS OR SPECIFIC RESEARCH
PROJECTS AND I HAVE TO SAY I'M
REALLY HARDENED AND IMPRESSED BY
HOW THIS COMMUNITY IS EVOLVING
TO A MUCH MORE COLLABORATIVE
APPROACH EACH TIME WE GATHER WE
SEE MORE AND MORE EVIDENCE OF
THAT. THIRD IS THE SYNERGY
ACROSS GOVERNMENT AND
COMMUNITIES. SEVERAL SESSIONS
HELP US COME UP WITH NEW IDEAS.
ABOUT HOW WE MIGHT WORK TOGETHER
AT MULTIPLE LEVELS. OUR FEDERAL
PARTNERS GATHERED TO SHARE THEIR
EXPERIENCES, THEY ANSWERED SOME
QUESTIONS, AND I HOPE YOU HAVE
HEARD UNIFORMLY THEIR PLEDGE TO
ALIGN TOWARD OUR COMMON GOAL OF
ENDING ADDICTION LONG TERM. THIS
IS GOING TO BE ESPECIALLY
IMPORTANT AS MORE AND MORE HEAL
DATA COMES ONLINE THE MEANINGFUL
PARTNERSHIPS WITH OTHER AGENCY
STATES AND COMMUNITY
ORGANIZATIONS WILL BE ESSENTIAL
TO BRING RESEARCH TO LIFE FOR
THE BENEFIT OF THE MILLIONS WHO
NEED IT. FOURTH OF COURSE IS THE
PATIENT ENGAGEMENT. WE KNOW THE
VOICE OF LIVED EXPERIENCE MUST
BE ACCOMPANIED BY ACTION AND
HEAL IS AN AGENCY LEADER IN THIS
AREA. KEEPING US HONEST ARE THE
HEAL COMMUNITY PARTNER COMMITTEE
MEMBERS. IN ADDITION TO THE MANY
COMMUNITY ADVISORY BOARDS THAT
ARE ACROSS THE HEAL RESEARCH
PROGRAMS. FINALLY, IN ADDITION
TO RECOGNIZING THE HARD WORK AND
ALL OF YOUR EACH DOING TO
ADDRESS A VERY SERIOUS PUBLIC
HEALTH CHALLENGE, I DO WANT TO
END MY BRIEF REMARKS BY THANKING
DR. REBECCA BAKER AND HER ENTIRE
TIME FOR ALL THAT YOU DO. SO
UNTIL MENTION WEEK, NEXT WE'RE
YEAR, WHICH HOPEFULLY WHICH WILL
BE TOGETHER IN PERSON KEEP UP
THE GREAT WORK AND WITH THAT
TURN IT OVER TO DR. BAKER.
REBECCA BACK TO YOU.
>> THANK YOU VERY MUCH, LARRY,
THANK YOU FOR AMAZING SUMMARY OF
RICH AND DEEP SET OF DISCUSSIONS
AND MEANING. I HAVE SLIDES TO
PROVIDE. NOT SURE I WANT TO GO
THROUGH IN TOO MUCH DAY TAIL
BECAUSE YOU PROVIDED EXCELLENT
SUMMARY OF WHAT WE DISCUSSED SO
PERHAPS WE CAN ADVANCE A LITTLE
BIT -- THESE ARE THEMES WE JUST
HEARD ABOUT. WE ALSO ASKED YOU
TO TELL US WHAT WAS MOST
IMPORTANT ABOUT WORK TOGETHER IN
HEAL AND WHAT YOU HEARD ABOUT IN
THE MEETING AND YOU CAN SEE
THOSE. AND I DON'T WANT TO SKIP
ON THE WORD CLOUD HERE,. NOTHING
IS SURPRISE BUT BIGGEST WORD IS
COLLABORATION. SO I WILL TAKE
THAT AS A CONTINUED ENDORSEMENT
FOR OUR EFFORTS TO PULL ALL OF
YOU TOGETHER TO SHARE DATA TO
INTEGRATE TREATMENT TO SUPPORT
PEOPLE IN RECOVERY BUT CONTINUE
TO BUILD CONNECTIONS BETWEEN
DISCIPLINES BETWEEN SECTORS
BETWEEN DIFFERENT RESEARCHERS
AND DIFFERENT RESEARCH EQUITIES
AND CAPABILITIES. NEXT SLIDE
PLEASE. WE HEARD FROM ALL
LEVELS OF FEDERAL LEADERSHIP
FROM ASSISTANT SECRETARY FOR
HEALTH AND DIRECTOR OF THE OITCP
AND THE WHITE HOUSE AND WE HEARD
ABOUT THE MANY COMPLIMENTARY
WAYS THE GOVERNMENT IS TAKING ON
THE NATIONAL CRISIS AND SOME OF
THE TRENDS THAT INFORM OUR WORK.
I THINK THIS QUOTE FROM ADMIRAL
LEVINE AT THE BOTTOM, ALL
AMERICANS DESERVE ACCESS TO
TIMELY EFFECTIVE TREATMENTS AND
SERVICE AND THAT GOES NOT JUST
FOR OPIOID MISUSE OPIOID
ADDICTION SUBSTANCE USE
DISORDERS, BUT ALSO FOR PAIN. SO
THIS IS RDD TO OUR PATIENTS TO
PROVIDE TREATMENTS AND SERVICE
IN AN EVIDENCE BASED WAY AND WE
ARE WORKING ON IT AS A
COLLABORATIVE. THE COMMUNITY
PARTNER COMMITTEE TOLD US ABOUT
THE IMPORTANCE OF BUILDING TRUST
HOW NAVIGATORS AND COMMUNITY
ENGAGEMENT DO THAT AN PLEASE DO
TAKE THE SURVEY. SO WE CAN LEARN
MORE WHAT WORKED FOR YOU IN YOUR
RESEARCH AND THEN WHAT YOU WISH
YOU COULD DO WITH ADDITIONAL
RESOURCES AND SUPPORT FROM NIH
TO CONTINUE TO BUILD OUT TRUST
TO BUILD THAT CONNECTION. WITH
PEOPLE. AT THE INTERSECTION OF
PAIN OPIOID USE GUESS DISORDER
THIS IS WHAT HEAL IS ABOUT WHERE
WE STARTED BRINGING RESEARCH
COMMUNITIES OF PAIN AND
SUBSTANCE USE DISORDER SCIENCE
TOGETHER THE ADDRESS THIS PUBLIC
HEALTH CRISIS. IT IS NOT EASY.
THE PATIENT POPULATIONS HAVE A
LOT IN COMMON. SOMETIMES THEY
ARE THE SAME INDIVIDUALS BUT WE
HAVE BIG CHALLENGES AND
ADDRESSING THOSE CHALLENGES AND
THOSE ARE NOT LIMITED TO ACCESS
AND PSYCHOLOGICAL MENTAL HEALTH
FACTORS CO-OCCURRING CONDITION,
REQUIRES INTEGRATED TREATMENT
AND FORTUNATELY WE HAVE SOME
RESEARCH UNDERWAY TO BEGIN TO
ADDRESS THAT. BUT I THINK IT IS
A CALL TO ALL OF YOU AND YOUR
PHASES OF RESEARCH TO THINK
ABOUT WHAT QUESTION AM I NOT
ASKING HOW CAN I INCORPORATE THE
WHOLE PERSON INTO MY RESEARCH
THAT I MIGHT NOT HAVE BEEN
PREPARED TO DO AND CAN I GET
SUPPORT FROM HEAL TO DO BETTER.
I THINK IN ADVANCING RESEARCH TO
PRACTICE THIS IS WHAT WE JUST
HEARD ABOUT FROM OUR FEDERAL
PARTNERS, HOW DO WE TAKE THESE
REALLY COMPLICATED QUESTIONS AT
THE INTERSECTION OF SCIENCE AND
HEALTHCARE AND HUMAN HEALTH AND
TURN THEM INTO SET OF EVIDENCE
BASED TOOLS. SO WE LEARNED ABOUT
A FEW ASPECTS OF THE HEAL
INITIATIVE DOING THIS -- MAKING
PROGRESS, UNDERSTANDING HOW
ACCESS TO MEDICATIONS FOR
TREATMENT USE DISORDER CAN
REDUCE RECIDIVISM IN PRISON AND
JAIL POPULATIONS, HOW I LOVED
THAT PRESENTATION FROM THE HEAL
COMMUNITY STUDY I'M FROM
MASSACHUSETTS ORIGINALLY SO MY
HEART SWELLED IN SEEING
COMMUNICATION CHAMPIONS TARGETED
TO LOCAL COMMUNITIES AND THAT IN
ACCORDANCE BUILDING MESSAGES
TOGETHER WITH THAT USER IS NOT
UNLIKE PATIENT ENGAGEMENT, IT
KEEPS US HONEST AND GIVES
REALITY CHECK WHAT IS MEANINGFUL
AND CUT THROUGH THE NOISE TO
REDUCE SOME OF THESE STIGMAS AND
CHANGE HOW PEOPLE GO ABOUT
SEEKING TREATMENT FOR OPIOID USE
DISORDER AND PREVENTING
OVERDOSES.S. AND WORKING WITH
HEALTHCARE SYSTEMS, HEALTHCARE
PROVIDERS, TO EMBRACE FULL SET
OF TOOLS WE HAVE FOR PAIN
MANAGEMENT, MAKING EASIER FOR
PATIENTS TO CHOOSE SAFE
EFFECTIVE TREATMENT THAT WILL
WORK FOR THEM. THE THEMES WE
HAVE TOUCHED ON SO I WON'T GO
INTO TOO MUCH DETAIL. IT IS
IMPORTANT TO REMEMBER AND AGAIN
PHIL RUTHERFORD REMINDED US NOT
EVERYTHING WORKS FOR EVERYONE.
OUR RESEARCH NEEDS TO INCLUDE
DIVERSE POPULATIONS BUT WE ALSO
NEED TO TARGET OUR INTERVENTIONS
FOR THOSE DISTINCT POPULATION
GROUPS AND REALLY UNDERSTAND
BUILD EVIDENCE AROUND WHAT IS
GOING TO WORK FOR THEM. WE
HEARD A REALLY INTERESTING FEAR
SIDE CHAT BETWEEN (INAUDIBLE)
AND MORE RA VOLKOW ABOUT
IMPORTANCE OF COMMUNICATION AND
EMPATHY, A THEME FOR HEALING WE
TALKED ABOUT LAST YEAR WITH
SURGEON GENERAL BUT IT WAS
ESPECIALLY POWERFUL COMING FROM
MY MAKE TREATMENT NORMAL AND
UNDERSTAND PEOPLE WITH SUBSTANCE
USE DISORDER ARE PEOPLE TOO, WE
KNOW THIS BUT IT CAN BE EASY TO
FORGET IN THE CONTEXT OF TRIAL,
OR -- ON ELECTRONIC HEALTH
RECORD AND AS POLICY ADVANCES
AND RESEARCH SUPPORTS IT, THIS
IS POWERFUL MESSAGE FOR ALL OF
US. WE HAVE AN AMAZING
PRESENTATION FROM THE FOLKS
WORKING ON THE HEAL DATA
ECOSYSTEM AND ALL OF ITS
COMPONENT PARTS. THE -- WE HAVE
AN INCREDIBLE USE CASE FOR HEAL,
LAUNCHING TOGETHER COMING ON
BOARD RIGHT WHEN A TIME WE FACE
URGENT PUBLIC HEALTH CRISIS AND
WE HAVE A LOT OF RESOURCES THE
ADDRESS IT SO TAKE PART TO PUT
YOUR DATA INTO THE PLATFORM
LEARN ABOUT HOW YOU CAN MAKE
YOUR DATA FAIR AND TURN TO US SO
WE CAN HELP YOU HOWEVER WE CAN.
NEXT SLIDE PLEASE. 'ALLY
IMPORTANT ASPECT OF HEAL THAT
SOMETIMES IS NEGLECTED BUT WE
WERE REMINDED FORCEFULLY BY DR.
CALIFF, WE NEED NEW OPTIONS AS
MUCH AS HARM REDUCTION AND
TRANSLATION OF RESEARCH TO
PRACTICE PRIA EVENTUAL OVERDOSE
NOW WE STILL NEED ADDITIONAL
OPTIONS FOR PEOPLE BOTH PEOPLE
WITH SUBSTANCE USE DISORDER AND
PEOPLE WITH PAIN. SO THAT
TRANSLATIONAL RESEARCH WE HAVE
IN THESE AREAS IS GOING TO BE
PART OF THESE COLLECTIVE
SCIENTIFIC SOLUTIONS. NEXT SLIDE
PLEASE. AND IN TODAY'S
DISCUSSION GROUPS WE GOT INTO
EVEN MORE KNOTTY AREAS WHERE
ADDITIONAL EVIDENCE IS
ESPECIALLY NEEDED IN THE AREA OF
POLYSUBSTANCE USE, HOW CAN
SCREENING BE A TOOL WE MAKE
BROADER USE OF SO THAT WE ARE
NOT JUST FOLLOWING ONE SUBSTANCE
USE DISORDER ANOTHER PATTERN OF
RISKY SUBSTANCE USE BUT PREVENT
BEFORE IT GETS TOO BAD AND
INTERVENE WHEN WE HAVE THE
OPPORTUNITY. INCREASE
SPECIFICITY OF TREATMENT, USE
THE POWER OF ALL BIOLOGICAL
UNDERSTANDING WE ARE BUILDING.
ENHANCE COMMUNITY FOCUSED
APPROACHES, SHARING DATA IN A
REALLY RICH AND
MULTI-DIRECTIONAL WAY, SO NOT
JUST ALONG SINGLE LINE BUT
EMBRACING INPUT AT THE
BEGINNING, MIDDLE AND EVEN AFTER
STUDY AND UNDERSTANDING HOW
TRANSLATION IS A BIG PART OF
WHAT WE SEEK TO ACCOMPLISH
THROUGH OUR COLLECTIVE WORK, ALL
OUR STUDIES ARE GOOD BUT
TRANSLATION OF HAIR FINDINGS
INTO PRACTICE IS GOING TO BE HOW
WE MAKE AN IMPACT FOR PATIENTS
FAMILIES CAREGIVERS IN NINES. SO
NEXT SLIDE PLEASE. THIS FEELS
LIKE JUST A MOMENT TO GO BEFORE
WE HEARD FROM FEDERAL PARTNERS
ABOUT IMPORTANCE OF
COLLABORATION, YOU HEARD THEM
SAY HOW IMPORTANT THE WORK ALL
OF YOU ARE DOING TO INFORM
PRACTICE TO INFORM NEEDED
REGULATORY POLICY AND GOVERNMENT
ACTIONS AND SO THE NEED FOR
RESEARCH IS CLEAR FORTUNATELY WE
HAVE A TERRIFIC TEAM AND ALL OF
YOU BUT THERE SEEM TO BE MANY
ACTIVITIES UNDERWAY THAT ARE
GOING TO AID OUR PATH FROM
INNOVATION TO IMPROVEMENTS FOR
PATIENTS AND WE WILL KEEP
CALLING ON FEDERAL PARTNERS TO
WORK WITH US TO BRING THOSE
FORWARD WITHOUT DELAY. AS YOU
HEARD FROM DR. TABAK WE FRAMED
THIS AGENDA AROUND THE
PRIORITIES FOR US BUT YOU CAN
FIND THEM IN OUR OPEN FUNDING
OPPORTUNITIES. SO HERE IS PAGE
WITH SOME OF THE OPPORTUNITIES
THAT ARE OUT NOW. I THINK WHAT
EARLIER YESTERDAY -- EARLIER IN
THE MEETING WE TALKED HOW THERE
ARE OVER 40 FUNDING
OPPORTUNITIES COMING OUT IN HEAL
INITIATIVE IT IS RICH TO TAP FOR
YOUR ONGOING RESEARCH IN
BUILDING THE COMMUNITIES THAT
YOU ALL LEAD. PLEASE LOOK AT
WHAT IS ON LINE NOW. THERE IS A
SCREEN SHOT HERE OF THE OPEN
FUNDING OPPORTUNITY THIS IS
SEARCHABLE SO GO IN AND LOOK FOR
THINGS THAT FIT BEST WITH WHAT
YOU WOULD LIKE THE STUDY MORE
ABOUT OR RESEARCH EXPERTISE
LIES. HERE IS HOW YOU CAN
SEARCH POST YOUR KEY WORD IN
RIGHT THERE, ONE MORE SLIDE. WE
HAVE ADDITIONAL RESEARCH
OPPORTUNITIES COMING SOON AND
MORE INFORMATION ABOUT THESE
CONDITION FOUND ON THE RESEARCH
CONCEPTS PAGE.