>>WELCOME TO HEAL AND
INTERDISCIPLINARY WORKING GROUP
MEMBERS TO THIS. SECOND MEETING
THIS WEEK AND THIRD IN THE MONTH
OF FEBRUARY, 2023, DISCUSSION OF
HEAL RESEARCH AND PROPOSED NEW
RESEARCH CONCEPTS THAT YOU WILL
HEAR FROM HEAL SCIENTIFIC TEAMS.
WE WILL START WITH A FEW TOPICS
FOCUSED ON TRANSLATION OF
RESEARCH TO PRACTICE FOR ABUSE
DISORDER AND OVERDOSE AND NEW
STRATEGIES TO PREVENT AND TREAT
VARIED MISUSE AND ADDICTION
OVERDOSE AND HAVE A DISCUSSION
LATER IN THE AFTERNOON AROUND
THERAPEUTIC DEVELOPMENT FOR
TREATMENT OF ABUSE DISORDER AND
REVERSAL AND CLOSE AND WE
RESERVED A GOOD AMOUNT OF TIME
AT THE END OF THE AFTERNOON TO
JUST KIND OF LOOK ACROSS ALL OF
THE DIFFERENT HEAL ACTIVITIES
THAT WE HAVE TOLD YOU ABOUT THIS
MONTH.
THEY ARE INCLUDING THE RESEARCH
UNDERWAY THAT WE DISCUSSED ON
FEBRUARY 6TH AS WELL AS SOME OF
THE OVERALL PORTFOLIO
CONSIDERATIONS AND PROPOSALS FOR
NEW RESEARCH TO BE ADDED IN THE
FUTURE.
WE WILL HAVE THAT 90 MINUTES AT
THE END FOR DISCUSSION AND WILL
TRY TO MAKE GOOD USE FOR THAT
AND MIGHT BE ABLE TO END A
LITTLE EARLY.
PLEASE DO STICK WITH US TO GET
TO THAT FINAL SYNTHESIS. WE
WILL HAVE BOTH DOCTORS JOIN US
FOR THAT PORTION.
ERIN, WOULD YOU PLEASE GO
THROUGH THE ROLL FOR
MULTI-DISCIPLINARY WORKING GROUP
MEMBERS AND EXECUTIVE COMMITTEE
MEMBERS?
>>HI. GOOD MORNING, EVERYONE.
I KNOW MULTI-DISCIPLINARY
WORKING GROUP MEMBERS JOINING
THROUGHOUT THE MEETING AND WILL
CALL OUT WHO I SEE NOW. LET'S
START WITH THE REAL DR. GEREAU.
>>HI, EVERYONE. GOOD TO SEE
YOU.
>>DR. BOSS BAUM?
>>GOOD MORNING.
>>DR. JONES?
>>GOOD MORNING.
>>HI, THERE. DR. PACE?
>>GOOD MORNING.
>>GOOD MORNING. LET'S SEE
HERE. I SEE DR. HENRY.
>>THANK YOU, ERIN, GOOD
MORNING, EVERYONE.
>>GOOD MORNING. DR. JERNI
BEGAN?
>>HELLO, EVERYBODY.
>>HELLO. DID I MISS ANYONE
FROM MDWG?
>>HI, EVERYONE. CHRISTIAN.
>>GOOD TO SEE YOU.
>>WELCOME.
>>ALL RIGHT. OF COURSE WE SEE
DR. VOLKOW. HOW ARE YOU?
>>HELLO. GOOD MORNING,
EVERYONE.
>>GOOD MORNING.
>>I SAW DR. KOR SHOTS POP ON
MAYBE NOT. I SEE DR. KRISL
WELL. HELLO.
>>HELLO, EVERYBODY. GOOD
MORNING.
>>GOOD MORNING DR. LANGEVIN.
HELLO. HOW ARE YOU DOING TODAY?
WE CAN'T HEAR YOU YET. YOU
MIGHT BE GETTING READY.
DR. LANGEVIN, CAN YOU HEAR US
OKAY?
>>I CAN.
>>PERFECT. WANTED TO MAKE SURE
YOUR AUDIO IS WORKING GREAT.
>>YES. THANK YOU.
>>ALL RIGHT. DID I MISS ANYONE
FROM THE EXECUTIVE COMMITTEE?
>>JENNIFER WEBSTER IS ON ON
BEHALF OF NIDER.
>>GOOD MORNING. WELCOME.
>>ALL RIGHT. YOU NOTICE WE
HAVE MANY PROGRAM DIRECTORS IN
HEAL AND CO-CHAIR COMMITTEE
MEMBERS THAT WILL PRESENT TODAY.
REBEKAH, I WILL TURN IT BACK
OVER TO YOU.
>>THANK YOU. I ALREADY SAID
WORDS OF WELCOME AND THANKING
THE GROUP FOR GIVING US SO MUCH
TIME AND GOOD INPUT AND ADVICE
OVER THE -- YESTERDAY'S MEETING
AND LOOKING FORWARD TO ANOTHER
GOOD MEETING TODAY.
ON THAT NOTE, I WILL ASK NORA IF
SHE HAS ANY WORDS OF WELCOME OR
AREAS SHE WOULD LIKE THE
PARTICULAR THOUGHTS AND INPUT
FROM MULTIDISCIPLINARY WORKING
GROUP TODAY.
>>I WANTED TO COMMENT JUST
THANKS FOR LETTING ME JUST
HIGHLIGHT WHAT WAS IMPRESSIVE
FOR ME YESTERDAY. IT WAS THE
LEVEL OF DISCUSSION THAT WE HAD.
THIS IS EXACTLY WHAT WE ARE
AIMING TO ACHIEVE WITH THE
PRESENTATION TO GET YOUR INPUT
AND TODAY IS DENSELY PACKED WITH
INFORMATION AND DIFFICULT
DECISIONS.
WE WILL HAVE TIME AT THE END
THAT IS A VERY GOOD OPPORTUNITY
TO GO INTO SPECIFICS.
THANK YOU ALSO FOR YOUR
WILLINGNESS TO BE HERE WITH US.
EXCELLENT. WE CAN MOVE ON. I
HAVE A FEW INTRO SLIDES. THANKS
FOR THAT, NORA. HERE WE ARE AT
DAY 2. NEXT SLIDE, PLEASE.
YOU CAN SEE HOW P MUCH HOU MUCHE
S YOU CAN DIENLEST IT. WE
SHARED WITH YOU THE DETAILED
RESEARCH CONCEPT TREATMENTS THAT
HAVE LOTS OF INFORMATION AND
DIFFERENT PDF DOCUMENTS WE
SHARED. WE WILL GO THROUGH THEM
BRIEFLY. EACH SCIENTIFIC TEAM
WILL END AND THREE ARE
REPRESENTED HERE TODAY AND THEY
WILL SHARE WITH YOU A FEW SLIDES
ABOUT WHAT THEY HAVE PROPOSED
AREAS FOR ALIGNMENT AND GAPS AND
NIH PORTFOLIOS AND SOME
QUESTIONS FOR DISCUSSION.
WE WILL TRY TO MOVE THROUGH AT A
HIGH LEVEL AND LEAVE TIME FOR
QUESTIONS AND DISCUSSION.
NEXT SLIDE, PLEASE.
FIRST TEAM WILL DISCUSS
TRANSLATION OF RESEARCH FOR
PRACTICE AND DISORDER AND
ADDICTION AND PREVENTING
OVERDOSE AND CO-CHAIRS ARE THE
TEAM ARE [INDISCERNIBLE] WIDA
AND MEMBERS OF NIEH.
>>TURNING IT OVER TO YOU AND
HERE IS WHAT WE SAW BEFORE FOR
SOME OF THE OTHER TEAMS VISUAL
DEPICTION OF THE RESEARCH
PROGRAMS LAUNCHED IN THIS AREA
FOR SCIENTIFIC HEAL AND THREE AT
TOP ARE PRESENTED TO YOU
FEBRUARY 6TH THAT THEY LAUNCHED
AND ACCOMPLISHED A LOT AND ARE
NOW IN THE POSITION TO BE
CONTINUED AND IN ALMOST A
DIFFERENT FORMAT OR DEPENDING ON
THE STUDY IN DIFFERENT WAYS
BASED ON CONTINUED SCIENTIFIC
NEED AND PUBLIC HEALTH IMPACT.
OTHER PROGRAMS LAUNCHED LATER
ARE GOING ON.
THOSE THAT ARE A LIGHTER COLOR
IN THE BOTTOM CORNER THERE ARE
THOSE -- THAT THE SCIENTIFIC
TEAM HAS PUT FORWARD FOR
CONSIDERATION FOR ADDING TO THE
PORTFOLIO IN 2024 THAT IS A
TOPIC OF DISCUSSION FOR THIS
MORNING.
NEXT SLIDE, PLEASE.
I THINK THIS IS WHERE I WILL
TURN IT OVER TO YOU, TISHA, AND
WENDY.
THANK YOU VERY MUCH FOR THE
PRESENTATION.
>>THANK YOU, REBEKAH.
SO, THIS IS A SCHEMATIC THAT I
THINK YOU HAVE SEEN THESE
BEFORE. JUST TO THINK ABOUT HOW
THE PORTFOLIO THAT WE FUNDED TO
DATE ALL FITS TOGETHER AND
LARGELY THESE BIG INITIATIVES
FIT INTO SETTINGS AND A NUMBER
OF CROSS-CUTTING THEMES AND
MOSTLY THAT CAME ON BOARD IN
20202 AS WELL AS DATA
INFRASTRUCTURE PIECES AND
HEALING COMMUNITIES THAT IS THE
LARGEST INITIATIVE REALLY CUTS
ACROSS ALL THESE DIFFERENT
SETTINGS AND HOPEFULLY GIVES A
SENSE OF NEXT ONES TO FIT INTO
THE BROADER PORTFOLIO. NEXT
SLIDE, PLEASE.
AGAIN, THESE ARE THE FOUR
CONCEPTS THAT WE WILL DISCUSS
TODAY. WE WILL JUST LAUNCH
RIGHT IN. I THINK THE FIRST ONE
UP, WENDY, IS GOING TO TAKE --
NEXT SLIDE, PLEASE.
>>YES. THAT IS RIGHT. THANK
YOU, TISHA. GOOD MORNING,
EVERYONE. THANK YOU FOR JOINING
US. FIRST WE WILL TALK ABOUT IS
DEVELOPING AN EVIDENCE BASED FOR
CO-OCCURRING CONDITIONS OF
ALCOHOL ABUSE DISORDER AND
SPECIFICALLY TO INTERVENTION AND
SPEAKING TO THIS GROUP WRU AWARE
OF SIGNIFICANT OVERLAP OF
INDIVIDUALS WISHUS WITH OPIOID
USE AND CO-OCCURRING ALCOHOL USE
THAT IS ESTIMATED TO ME AS MUCH
AS 30% OF THE POPULATION THAT
ARE INDIVIDUALS WITH OPIOID
DISORDER THAT HAVE ALCOHOL USE
IN HIGH AMOUNT THAT CREATES
CHALLENGES FOR TREATMENT. IN
PARTICULAR, THERE MAY BE
INTERACTIONS BETWEEN MEDICATIONS
USED FOR DIFFERENT CONDITIONS.
AND IT MAKES IT QUITE
CHALLENGING TO WORK WITH THIS
POPULATION THEN AND THINK ABOUT
HOW WE NEED TO TAILOR AND
DEVELOP INTERVENTIONS FOR THIS
GROUP.
SO, WE ALSO KNOW THAT ALCOHOL IS
OFTEN A CONTRIBUTING FACTOR TO
OVERDOSES AND IN FACT THOSE WHO
GO INTO GOOD TREATMENT FOR ABUSE
DISORDER COME OUT AND USE
SUBSTANCE ABUSE ALCOHOL PUTTING
THEM AT HIGH RISK IF THEY REDUCE
ELAPSE AND HIGH RISK OF OPIOIDS
AND ALCOHOL AND CONCEPT HERE IS,
YOU KNOW, DESPITE THE FACT THAT
WE KNOW THIS CO-OCCURRENCE
EXISTS, WE NEED MORE RESEARCH TO
REALLY IDENTIFY AN EFFECTIVE
ARSENAL OF TREATMENTS WITH
MEDICATIONS AND PSYCHOSOCIAL
APPROACHES AND COMPLEMENTARY
TYPES OF INTERVENTION TO TARGET
THIS PARTICULAR GROUP THAT HAS
BEEN QUITE MUCH MORE DIFFICULT
TO MANAGE.
THAT IS PROPOSED HERE IS TO
THINK ABOUT HOW TO LEVERAGE THE
ONGOING WORK AND HEAL SO WE CAN
LEARN MORE ABOUT THIS PARTICULAR
SUBGROUP OF INDIVIDUALS BY
EXPANDING SUBJECT RECRUITMENT
ENROLLING INDIVIDUALS WITH A
CO-OCCURRING CONDITION WITH
ADDITIONAL ALCOHOL USE INTO
EXISTING PROJECTS EITHER TO, YOU
KNOW, MAKE SURE WE ARE
COLLECTING COMPREHENSIVE DATA
ABOUT ALCOHOL USE OR INITIATING
ADDITIONAL ANCILLARY STUDIES OR
OTHER THINGS TO ENROLL THAT
PARTICULAR SUBGROUP INTO ONGOING
STUDIES TO LEARN MORE ABOUT HOW
INTERVENTIONS WORK IN THAT
PARTICULAR POPULATION AND WE
KNOW ACROSS HEAL THERE IS
ALREADY IN CASES GREAT
CHARACTERIZATION OF ALCOHOL USE
AND WHAT WE CAN DO TO INCREASE
SECONDARY ANALYSIS DATA TO
BETTER INFORM US HOW TO MANAGE
IN THIS PARTICULAR POPULATION
AND IDEA HERE IS HOW TO LEVERAGE
WHAT WE ARE DOING AND EXPAND
WHAT WE ARE DOING TO LEARN MORE
ABOUT THIS CO-OCCURRING SORT OF
CONDITIONS.
NEXT SLIDE, PLEASE.
SO, HOW DID IT SIT OVERALL WITH
WHAT WE ARE DOING IN HEAL?
AS I MENTIONED, SOME PROGRAMS
ARE COLLECTING DATA IN THIS
SPACE AND HEAL DATA ECOSYSTEM
GIVES US A PLATFORM TO BE ABLE
TO DO ANALYSIS ACROSS DIFFERENT
STUDIES AND BEING ABLE TO HAVE
CONSISTENT DATA COLLECTED AROUND
ALCOHOL USE DISORDER AND THE
AMOUNT OF USE OF ALCOHOL IN
INDIVIDUALS WOULD ALLOW US TO
USE THAT PLATFORM TO CONDUCT
CROSS-STUDY ANALYSIS.
WE HAVE A NUMBER OF PROGRAMS
THAT ARE RIGHT FOR EXPANSION AND
RIGHT FOR DELVING IN AND DOING
MORE SPECIFIC ANCILLARY STUDIES
OR LIKE I SAID ENHANCING THEIR
DATA CLUCKS THAT ENHANCES
POLYUSE SUBSTANCE PROGRAM AS
WELL AS EMPOWER PROGRAM AND
OPTIMIZING SERVICE DELIVERY FOR
THOSE WITH OD CURRENT CONDITIONS
AS WELL AS DATA METHODS PROGRAMS
AND WE THINK THESE WOULD BE SOME
OF NOT LIMITED TO THIS GROUP OF
PROGRAMS.
BUT, CERTAINLY THEY ARE PROGRAMS
THAT WOULD GIVE US THE
OPPORTUNITY TO LEARN MORE IN
THIS SPACE.
SO, NEXT SLIDE.
WE HAVE A SET OF DISCUSSION
QUESTIONS HERE.
CAN I JUST CHECK WITH ERIN OR
REBEKAH AS TO WHETHER YOU WANT
US TO DELVE INTO THESE NOW OR
WHETHER WE SHOULD GO AHEAD AND
NOTE THAT THESE ARE QUESTIONS WE
WILL BRING BACK FOR DISCUSSION
WHEN WE GET TO THE END AND WHAT
WOULD BE THE PREVENS TODAY?
>>WELL, IT IS A LOT TO GET
THROUGH TIMEWISE.
YOU HAVE DONE A GOOD JOB GETTING
STARTED.
I THINK WE CAN TRY TO HAVE A
BRIEF DISCUSSION WITH
RECOGNITION THAT IF WE GO TOO
LONG WE WILL HAVE TO KIND OF
SWITCH GEARS.
>>OKAY. SOUNDS GREAT,
PROFESSOR. I KNOW WE HAD A FEW
DISCUSSIONS ASSIGNED FOR THIS
ONE. WE WILL TAKE QUESTIONS.
YOUR HAND WENT UP VERY QUICKLY.
IT ALSO APPEARED. DID YOU WANT
TO --
>>I WAS ABOUT TO SAY THAT
DISCUSSANT THING IS TRICKY AND
IF PEOPLE RACED THEIR HAND LET'S
GO AHEAD.
>>LET'S START. I DO HAVE
COMMENTS.
>>OKAY.
>>LET DISCUSSANTS GO.
>>OKAY. GAIL, YOU WERE ONE.
>>I AGREE. I DON'T THINK I'M A
DISCUSSANT.
>>I THINK WE SHOULD GO BY
HANDS.
>>YEAH. I THINK GAIL YOU ARE.
>>OKAY. GOOD. GOOD. THAT IS
GREAT. THIS IS A REALLY
IMPORTANT TOPIC AND WE ARE
SEEING MORE AND MORE OF THIS
EVERY DAY IN AN IS A VERY
DIFFICULT LIFT AND NOT EXACTLY
SURE HOW TO TREAT THESE
INDIVIDUALS.
OF COURSE, FIRST, IT IS
COMPLICATED BECAUSE OF EVEN
FINDING DEGREE OF WITHDRAWAL OF
OUD IF THEY ARE USING LOTS OF
ALCOHOL AS WELL. THAT IS TOUGH.
THEN, OF COURSE, TREATING THEM
WITH SAME NOREP NEF REN IS
DIFFICULT AND WHEN ADDING ON A
BENZO FOR WITHDRAWAL OF ALCOHOL
OR EVEN GABBA PENTON. I'M
EXCITED ABOUT THIS FOR
IN-PATIENT SETTINGS AND WHAT IS
MEDICATION FOR ACUTE WITHDRAWAL
AND THERE IS LOT OF OBVIOUSLY
DATA COLLECTED TO FIGURE OUT
WHAT TO DO LONG TERM AND GETTING
PEOPLE WITHDRAWING FROM ALCOHOL
HOW TO TRAEL THAT ALONG WITH
TREATMENT OF OUD THAT CAN BE
VERY TRICKY. I'M EXCITED ABOUT
FIGURING IT OUT AND THINK MANY
PIS FROM HILL STUDIES WOULD BE
HAPPY TO CONTRIBUTE. WE ARE
SEEING IT A LOT. THEY ARE NOT
PEOPLE WE PUT IN TRADITIONAL
STUDIES OR MY HEAL STUDY. THEY
ARE TOO COMPLICATED AND HAVE TO
BE MORE ADDRESSED IN AN
IN-PATIENT SETTING AND NOT SURE
IT IS TRUE. WE WILL LEARN FROM
YOU. THANK YOU.
>>WELL, I CAN SAY I AGREE WITH
EVERYTHING GAIL JUST SAID AND IT
IS EXTREMELY IMPORTANT AND
ACKNOWLEDGING THE FACT THAT MANY
TIMES PEOPLE -- YOU KNOW, HEALTH
IS DRAGGED DOWN MORE BY WEB OF
COMORBIDITIES THAN ANY
PARTICULAR DISORDER THEY ARE
STRUGGLING WITH. WE TEND TO
STUDY DISORDERS IN A KIND OF
SILOED WAY AND TRYING TO ISOLATE
MECHANISMS AND SO ON. IN THE
REAL WORLD, PEOPLE ARE REALLY
OVERCOME BY THESE COMORBIDITIES
THAT COMPLICATE TREATMENT AND
ILLNESS AND HEALTH AND SO ON AND
IS A REALLY IMPORTANT
INITIATIVE.
>>ANY OTHER DISCUSSANTS? I
COMPLETELY CONCUR WITH
EVERYTHING THAT HAS ALREADY BEEN
SAID AND WOULD LIKE TO ALSO AM
MRIF PI COMPLICATIONS WITH
BENZODIAZEPINES AND -- WHILE
PATIENTS HAVE THESE COMPLICATED
BENZO OR -- AND/OR ALCOHOL-USE
DISORDERS AND NOT NARROWING
OURSELVES TO ONLY THE ANTAGONIST
BUT TO ALSO THINK ABOUT ARE
MEDICATIONS LIKE [INDISCERNIBLE]
OR OTHER THINGS THAT COULD ALSO
BE INCLUDED IN STUDY AND
ADDITIONALLY TO ALSO THINK ABOUT
MINORITY POPULATIONS OR
MARGINALIZED POPULATIONS THAT
MIGHT NOT HAVE BEEN ALWAYS
INCLUDED IN STUDIES AND PREGNANT
INDIVIDUALS ARE DESERVING OF
BEING INCLUDED IN COMPLICATED
PROTOCOLS TO UNDERSTAND HOW BEST
TO TREAT THEM AS WELL AS
INDIVIDUALS THAT ARE LGBTQYA.
THANK YOU.
>>OKAY. THANK YOU.
>>YEAH. GO AHEAD.
>>NED HAS HIS HAND RAISED.
WOULD YOU LIKE TO --
>>YEAH. I AGREE. SUPER
IMPORTANT TOPIC. I CAN SAY
CLINICALLY TRYING TO TREAT
PATIENTS LONG TERM IS AN
IMPORTANT PROBLEM AND COUPLE
QUICK COMMENTS.
ONE, WRITE-UP SAYS SUBSTANCE USE
DISORDERS AND PEOPLE DRINKING
ALCOHOL AND IF TRUE AND
GUIDELINES OR PRESCRIBING
MEDICINE SAYS THAT WE SHOULD
ABSOLUTELY DO RESEARCH TO
CHALLENGE THAT. I THINK IT IS
WRONG. SOMEONE WITH OPIOID USE
DISORDER HAS TO BE TREATED AND
YOU SHOULD DO SOMETHING ABOUT
THE ALCOHOL BUT YOU HAVE
EFFECTIVE TREATMENT FOR OPIOID
USE DISORDER THAT SHOULD BE
TREATED. AGAIN, THAT IS -- I
CAN IMAGINE IF NOT IN THE
GUIDELINES IT IS A BELIEF THAT
LOTS OF PEOPLE HAVE. THAT
SHOULD BE CHALLENGED WITH DATA
AND PUT IN THE CHAT A EXAMPLE OF
SECONDARY ANALYSIS OF LARGE CTM
STUDY IF PEOPLE ARE INTERESTED.
SUGGESTING DRINKING IS BETTER TO
[INDISCERNIBLE] TREATMENT.
HIDDEN WITHIN THAT, OF COURSE,
PATIENTS THAT KEEP DRINKING AND
RELAPSE AND 50% OF PATIENTS IN
THE STUDY ARE -- HAVE A GOOD
OUTCOME OVER 6 MONTHS.
THOSE REALLY ARE MY COMMENTS.
IS THIS RESTRICTED TO SECONDARY
ANALYSIS AND THINGS LIKE THAT?
IT IS NOT --
>>WE WILL TAKE A MULTIPRONG
APPROACH HERE AND WE THOUGHT
THERE WOULD BE OPPORTUNITY FOR
SECONDARY ANALYSIS AND EXPANDING
ONGOING WORK AND POTENTIALLY
FUNDING NOVEL WORK AS WELL THAT
WE FELT LIKE TAKING A MULTIPRONG
APPROACH TO LEVERAGE WHAT IS
ONGOING AND WHAT DATA HAS BEEN
COLLECTED DOESN'T MAKE SENSE AND
GETTING A BETTER HANDLE WHAT IS
HAPPENING IN THE SPACE.
>>RIGHT. TWO QUICK COMMENTSES.
ONE IS CONSIDER PTSD WHICH.
>>YEAH.
>>IT IS A COMMON COMORBIDITY.
LET NOT FORGET ABOUT DISUL FOR
AM THAT MOST WRITE OFF AND IS
EXTREMELY HIGHLY EFFECTIVE TO
GET A SIGNIFICANT OTHER TO GIVE
IT TO THE PATIENT EVERY DAY THAT
IS A POWERFUL TREATMENT FOR
STOPPING DRINKING AND WRITE-UP
MENTIONED PSYCHOSOCIAL
INTERVENTIONS THAT ARE ALSO
GOOD.
YOU NEED A PSYCHOSOCIAL
INTERVENTION THAT WILL ENGAGE A
SIGNIFICANT OTHER TO GIVE DISUL
FOR AM THAT WORKS GREAT IF YOU
GET SOMEBODY TO GIVE IT TO THE
PATIENT.
>>GREAT.
>>THOSE ARE MY THOUGHTS.
>>GREAT.
DR. VOLKOW?
>>YES. MY QUESTION IS
OBVIOUSLY GREAT RECEPTION HAVING
A MORE COMPREHENSIVE STUDY OF
PATIENTS WITH COMORBIDITY THAT
IS REALITY THAT WE ARE LOOKING
FOR AND COMBINATION THAT IS AN
OBVIOUS WILL I THIRD ELEMENT
THAT IS VERY RELEVANT THAT IS
THAT OF PAIN. I BRING IT UP AND
THINK THAT THE OPPORTUNITY THAT
WE HAVE, WE NEED OR SHOULD BE
ACTIVELY SEEKING OUT HOW TO
INTEGRATE CONDITIONS.
AND ALCOHOL USE DISORDER
PATIENTS HAVE HIGHER RATES OF
PAIN AS WE KNOW. ALCOHOL ITSELF
MIGHT PROMOTE IT. THIS INTERNAL
USE OF OPIOIDS AND THAT
INTERACTION IS WHAT IS VERY
IMPORTANT THAT I BEHOOF FOR US
TO THINK AS WE ARE LOOKING IN
TERMS HOW WE DO WE ANALYZE DATA
AVAILABLE OR GENERATE NEW
PROJECTS THAT WE THINK ALSO
ABOUT THE COMBINATION WE SEE.
>>PANE CAME UP AS CO-OCCURRENCE
FOR PTSD AND NEGATIVE EMOTIONAL
STATES AND UNDERLYING SEVERAL
ELEMENTS WITH ANOTHER THING THAT
CAME UP THAT WE HAVE BEEN
DISCUSSING THIS AND WILL
DEFINITELY MAKE SURE THAT THE
PAIN ELEMENT IS PART OF THAT.
ALL RIGHT. ONE MORE, GAIL.
YEAH?
>>I WANTED TO ADD I WAS
HEARING, NED. THESE INDIVIDUALS
I SEE IN THE EDR ARE OFTEN
HOMELESS BECAUSE THEY ARE USING
EVERYTHING THEY CAN GET. ALL
RIGHT?
THAT MAKES IT SO DIFFICULT. I
CAN'T GIVE THAT. IF I HAVE A
PATIENT WITH SOMEONE AT HOME OR
WHATEVER I CAN GIVE AND GIVE
THEM TO GIVE CERTAIN AMOUNT OF
BENZOS OR GABBA PENTON OR
WHATEVER THEY DON'T OR DON'T
HAVE OTHER SIGNIFICANT OTHERS
AND WHY THIS IS SO IMPORTANT.
IF I COULD JUST FIGURE OUT EVEN
FOR A COUPLE DAYS TO GET PEOPLE
STARTED ON THE RIGHT MEDS THEN
HOW TO PROGRESS MAYBE AFTER THAT
WOULD BE WONDERFUL. THEY ARE --
YOU CAN'T OVERESTIMATE HOW MANY
PEOPLE HAVE UNSTABLE HOUSING AND
ALL STUDIES WE ARE FINDING LIKE
OVER 50% THAT IS UNHEARD OF IN
THE PAST. IT IS -- IT IS REALLY
AN EPIDEMIC.
>>A ROLE FOR PETERS IN THAT
POSSIBLY?
>>I DON'T KNOW.
>>YEAH.
>>I DON'T KNOW.
>>MAYBE TRUST --
>>NAVIGATORS. I LIKE
NAVIGATORS.
>>NAVIGATORS.
>>YOU KNOW, AGAIN, PEERS ARE A
PEER OF 1 WHO HAS ONE
EXPERIENCE.
>>YEAH, YEAH.
>>THESE ARE COMPLICATED
INDIVIDUALS THAT I THINK THAT
PEOPLE WHO ARE USING SUBSTANCE
USE NAVIGATORS WHETHER DR.
HERRING OR WE HAVE RESEARCH AND
COULD BE IN PROJECT RECOVERY BUT
ARE NAVIGATORS UNDER THE
DIRECTION OF US WOULD BE REALLY
HELPFUL. IT IS SO COMPLICATED.
DON'T OVERESTIMATE THINKING
ABOUT THESE TRIALS HOW MANY
PEOPLE ARE HOMELESS. SO --
>>THANK YOU. WONDERFUL
FEEDBACK AND COMMENTS FROM THE
GROUP AND REALLY HELPFUL AND
50%, GAIL, IS AMAZING THAT YOU
ARE SAYING THAT HIGH RATE.
REBEKAH, SHOULD WE GO TO THE
NEXT ONE?
>>YES, PLEASE.
>>OKAY. NEXT ONE WE WANT TO
TALK WITH ALL OF YOU ABOUT, ONE
MORE SLIDE.
PERFECT.
LEVERAGING IN-PATIENT MEDICAL OR
SURGICAL HOSPITALIZATION TO
IMPROVE OUTCOME FOR PEOPLE WHO
USE DRUGS AND CHALLENGE HERE IS,
YOU KNOW, HOW DO WE MORE
FREQUENTLY OR HOW DO WE TAKE
ADVANTAGE OF OPPORTUNITIES TO
SCREEN FOR AND CONNECT PEOPLE TO
SERVICES?
WHEN WE THINK ABOUT INDIVIDUALS
IN AN IN-PATIENT SETTING, IS IT
AN OPPORTUNITY TO POTENTIALLY
SCREEN FOR INDIVIDUALS
ESPECIALLY GIVEN THE FACT THAT
INDIVIDUALS WHO WHO THEY ARE
HOSPITALIZED FOR MEDICAL OR
SURGICAL CONDITIONS MIGHT HAVE
MORE COMPLICATED TREATMENT
OUTCOMES AND MIGHT BE MORE
CHALLENGING TO FOR EXAMPLE TO
GET VENUS ACCESS OR OTHER THINGS
AND THERE CAN BE STIG
MATIZIZATION FOR INDIVIDUALS
THAT THEY RECEIVE AND MEDICAL
CARE LEADING TO POOR OUTCOMES
AND IDEA IS HOW TO DO WE EXPAND
LINKAGE TO CARE FOR HOSPITALIZED
INDIVIDUALS TO USE DRUGS AND
TESTING MODELS MAYBE THAT HAVE
BEEN STUDIED IN A SINGLE
PARTICULAR SETTING OR IN
SHORT-TERM SETTINGS ACTUALLY
MAKING THIS SUSTAINABLE
TREATMENT SERVICE INFRASTRUCTURE
IN PROGRAMS AND STUDY HOW TO
MAKE IT SUSTAINABLE, I SHOULD
SAY.
THE IDEA HERE WOULD ALSO BE
LOOKING AT HOW TO IDENTIFY
BARRIERS TO TREATMENTS AND
ENGAGEMENT AND RETENTION AND
ADDRESSING ISSUES SUCH AS STIGMA
AND ACCESS AND SOCIAL
DETERMINANTS OF HEALTH TO GET
PEOPLE TO MOVE FROM IN-PATIENT
CARE MOVING INTO COMMUNITY
TRANSITION FOR TREATMENT.
IDEALLY HERE BUILDING UPON AND
CREATING SUSTAINABLE MODELS THAT
WOULD WORK AND LOOKING AT
DIFFERENT SETTINGS WOULD BE
POSSIBILITIES TO LOOK AT HERE
THAT RURAL URBAN AND LARGE
VERSUS SMALL AND BOTH SAFETY NET
SETTINGS AND STRATEGIES TO
SUPPORT REALLY SUCCESSFUL
IMPLEMENTATION AND
SUSTAINABILITY AND CARE AFTER
HOSPITAL DISCHARGE AND HOW WE
MOVE THAT TO THE CASE. SO,
CERTAINLY THIS WOULD ALSO
PROVIDE OPPORTUNITY TO LOOK AT
HOSPITAL REEMISSIONS AND
LONG-TERM OUTCOMES AROUND
MORBIDITY AND MORTALITY OF
SUBSTANCE USE DISORDER
IDENTIFYING AND FINDING PEOPLE
SORT OF IN THIS WAY.
NEXT SLIDE.
HOW DOES IT FIT AND COMPLEMENT
WHAT WE ARE CURRENTLY DOING
WITHIN HEAL?
AS WE EXPAND SOME WORK WE ARE
DOING TO A BROADER SORT OF
SCREENING AREA OF, YOU KNOW,
MORE BROADLY IN-PATIENT AND NOT
INDIVIDUALS WITH SPECIFIC SORT
OF VERY HIGH RISK THAT MIGHT
IDENTIFY THEM AS INDIVIDUALS
WITH SUBSTANCE USE DISORDER AND
WE ARE CERTAINLY AWARE THAT CPN
IS CURRENTLY DOING A STUDY OF A
MULTICOMPONENT PROGRAM ACROSS
MULTIPLE SITES THAT ARE REALLY
TARGETING HOSPITALIZED PATIENTS
WITH INFECTIOUS DISEASES AND
COMPLICATIONS LIKE BACTERIA
CARDITIS AND SCREENING
IMPLEMENTING ACROSS HOSPITAL
IN-PATIENT SETTING AND
IMPLEMENTING BEST PRACTICES AND
THERE IS SOME STUDIES THAT HAVE
BEEN DONE SHOWING YOU CAN DO
THIS. IT LEADS TO FEWER
READMISSIONS THAT HOW DO WE
SCALE IT UP AND GET IT
IMPLEMENTED TO ACTUALLY UTILIZE
IN MORE SETTINGS THAN JUST A
COUPLE PLACES WHERE IT HAS BEEN
STUDIED?
IDENTIFYING AND ADDRESSING
BARRIERS TO TREATMENT, AGAIN, TO
ENGAGEMENT AND RETENTION AND WE
KNOW IT HAS BEEN DONE AND WE
HAVE PROGRAMS ACROSS FIELDS
DOING THIS AND MOSTLY IN OUD
TREATMENT SETTINGS AND MRNL
DEPARTMENTS NO THE ADDRESSING
STIGMA MORE BROADLY ACROSS THE
IN-PATIENT HOSPITAL SETTING THAT
PROVIDES CERTAINLY AN
OPPORTUNITY TO APPLY WHAT WE
HAVE LEARNED IN THE EMERGENCY
DEPARTMENT WOULD IT WORK IN
OTHER PATIENT SETTINGS ACROSS
THE HOSPITAL. INITIATIVE REALLY
SEEKS TO ENCOURAGE RESEARCHERS
TO BUILD ON STUDIES THAT HAVE
BEEN DONE AND BROADEN THEIR
REACH TO UNDERSTAND
IMPLEMENTATION.
NOT DUPLICATING PRIOR WORK AND
HOW DO WE REALLY ENCOURAGE
PROJECTS FROM ACROSS A MORE
VARIETY OF REGIONS ACROSS THE
COUNTRY AND AS WELL AS DIFFERENT
HOSPITAL SYSTEM TYPES THAT WOULD
BE SOMETHING THAT WE WOULD HOPE
TO DO WITH THAT.
SO, I THINK THAT WE ARE ON TO
THE NEXT SLIDE THAT IS THE
DISCUSSION NOTES.
WE HAVE A SET OF QUESTIONS AND
HOW ARE WE DOING FOR TIME,
REBEKAH?
SHOULD WE MOVE ON AND COVER
OTHER ONES OR TAKE A FEW
COMMENTS HERE.
>>I WAS GOING TO SAY I THINK WE
ARE OKAY FOR RIGHT NOW. WE ARE
OKAY. GO RIGHT AHEAD AND WE CAN
HAVE DISCUSSION AND HEAR FROM
THE GROUP.
>>OKAY. YEAH. CURIOUS WHAT
PEOPLE THINK.
YEAH. GO AHEAD. YES?
>>OKAY. I DON'T WANT TO JUMP
THE LINE.
>>IT IS OKAY. IT IS OKAY.
>>SUPER IMPORTANT POPULATION
AL
ALSO.
I'M INVOLVED WITH COLLEAGUES IN
NCATS-FUNDED STUDY LOOKING AT
PATIENTS ADMITTED WITH OPIOID
USE DISORDER AND INFECTIOUS
DISEASE AND STUDIES ARE FINISHED
IN NEXT YEAR AND HAVE RESULTS
AND PUT METHODS PAPER IN THE
CHAT. THESE PATIENTS ARE SUPER
AND SEVERELY ILL WITH ALL KINDS
OF MEDICAL PROBLEMS AND LOTS OF
TIMES HAVE SOCIAL DETERMINANTS
IN HOMELESSNESS AND GAIL THE
MRNL DEPARTMENT POPULATION AND
RESEARCH ASSISTANCE IN THE STUDY
FUNCTION LIKE NAVIGATORS AND
PATIENTS NEED THAT AND WHEN YOU
DON'T WANT RESEARCH STUDY TO DO
THAT BUT YOU WANT THE ACTUAL
TREATMENT DELIVERY SYSTEM TO DO
THAT.
THEY NEED THAT. THIRD THING A
LOT OF TIMES THEY KNOW WHAT THEY
WANT, MENLO DON'T AND NOREP NEF
REN AND INJECTION NOREPINEPHRINE
AND A PROGRAM THAT GIVES
PATIENTS A MENU AND ALLOWS THEM
TO CHOOSE WHAT THEY ARE
INTERESTED IN. OF COURSE, YOU
GET INTO BARRIERS LIKE IS
INJECTION EPINEPHRINE ON FORM
YOU'LLARY AND MENLO DON'T CLINIC
TO BE REFERRED TO. LOTS OF
ISSUES.
RECRUITMENT HAS BEEN AN SIV KIND
OF. SO MANY REASONS THAT
PATIENTS DON'T WANT TO
PARTICIPATE INCLUDING THEY DON'T
WANT TO BE RANDOMIZED AND THEY
KNOW WHAT THEY WANT.
>>THAT IS GREAT FEEDBACK AND
GOOD TO HEAR WHAT YOU ARE
HEARING IN YOUR ONGOING STUDY.
>>YEAH.
>>ONE OF THE DISCUSSANTS ARE
HERE AND THIS IS AN IMPORTANT
PATIENT POPULATION AND THERE IS
A TREMENDOUS NUMBER OF BARRIERS
AND HOSPITAL SETTING I WORK IN,
IN-PATIENT WE LOOKED IN LESS
THAN 1% OF PATIENTS WERE BEING
SCREENED FOR 1%.
I THINK THAT, YOU KNOW SHGS JUST
A VERY BASIC THING AND MEDICAL
RECORD SYSTEM WHAT SCREENING
TOOL IS BEING USED AND FOCUSING
ON VERBAL SCREENING TOOLS NOT
URINE DRUG TESTING AND
LIMITATIONS FOR SCREENINGS TOO.
MAKING SURE YOU HAVE HOSPITAL
ADMINISTRATORS ON BOARD WHEN
ASKING WHO YOU THINK
STAKEHOLDERS SHOULD BE IF YOU
DON'T HAVE HOSPITAL
ADMINISTRATORS ON BOARD THIS
WILL NEVER WORK. YOU NEED TO
HAVE MEDICAL RECORDS FOLKS AND
YOUR BILLING AND HAVE, YOU KNOW,
INFORMATION AND SUPPORT FOR
DOCUMENTATION. IF YOU WANT ANY
OF THESE THINGS IN --
INTERVENTIONS TO BE SUSTAINED
THEY HAVE TO BE IMBEDDED IN THE
HOSPITAL SYSTEM AND MAKE MONEY
FOR HOSPITALS THINKING
SEQUENTIAL INTERCEPT MAPPING
COULD BE GOOD FOR PATIENT
SETTING AND THROUGHOUT TO
UNDERSTAND REALLY WHERE ALL OF
THE BARRIERS ARE. THEN, TWO,
YOU KNOW, SOMEHOW IT IS
ACCEPTABLE TO SYSTEMATICALLY
DISCRIMINATE AGAINST PATIENTS
THAT HAVE A SUBSTANCE USE
DISORDER.
THERE ARE OTHER DISEASES THAT I
THINK THAT YOU KNOW PLEASE DON'T
UNDERESTIMATE NOT JUST STIGMA
BUT ALSO DISCRIMINATION FOR
PATIENTS.
>>YES.
GREAT. WONDERFUL. WONDERFUL
POINTS P.
DEFINITE WILL IN THE BROADER
CONCEPT I HOPE YOU SAW ELEMENTS
INCLUDED AROUND DISCRIMINATION
AND THOSE BARRIERS.
>>WE ARE HOPING TO ADDRESS THAT
MANY SYSTEMS DON'T SCREEN AT ALL
ROUTINELY. YEAH. WONDERFUL.
>>YEAH.
>>I AGREE WITH ALL THAT. I WAS
GOING TO ADD THAT ONE THING
THROUGH ONE OF OUR STUDIES, CTN
STUDIES WE DID FOCUS GROUPS ON
PATIENTS THAT WE HAD SEEN NEXT
D. SEVERAL OF THEM HAD
MENTIONED HOW THEY EVENTUALLY
GOT INTO TREATMENT WAS BEING IN
THE HOSPITAL WHETHER AORTIC
VALVE REPLACEMENT OR SOMETHING
LESS SERIOUS THAT THE HOSPITAL
-- THEY HAD A LONG TIME IN THE
HOSPITAL TO ACTUALLY ENGAGE AND
START ON TREATMENT THAT THEY
FELT COMFORTABLE WITH.
IT REALLY TURNED THEM AROUND.
THIS IS A GREAT OPPORTUNITY.
THEY ARE THERE. WE HAVE ALL
DIFFERENT MATERIAL OF THINGS WE
CAN USE ON PEOPLE THAT ARE IN
HOSPITALS AND ARE VERY DIFFERENT
THAN WE CAN USE IN AMBULATORY
SETTINGS AND GET PEOPLE FEELING
COMFORTABLE PRETTY SOON.
WE CAN MAKE SURE WE ADDRESS
THEIR ISSUES AND THIS IS
WONDERFUL AND GREAT WE HAVE TO
GET MORE HOSPITALS TO DO THAT
AND SHOW THEM THAT PATIENTS ARE
ALREADY THERE AND REPEATEDLY ARE
COMING BACK. IT IS COSTING THEM
MORE MONEY AND MORE HOSPITAL
BEDS THAN IF THEY WERE TO TAKE
CARE OF THEM INITIALLY AND MORE
HOSPITAL BEDS TO BE USED FOR
OTHERS AND FINANCIAL PIECE IS
WHAT I ALWAYS FIND FLIPS
HOSPITAL ADMINISTRATORS.
THIS IS GREAT. THANK YOU.
>>I HAVE LITTLE TO ADD TO WHAT
DISCUSSANTS SAID AND IT IS
OBVIOUSLY A HUGE MISSED
OPPORTUNITY TO ALLOW IN-PATIENT
VISITS TO GO BY WITHOUT FOCUS ON
SUBSTANCE UDISORDERS THAT SEEMS
OBVIOUS TO ME TO OVERCOME
BARRIERS THAT EXIST THERE.
>>I JUST WANT TO I FORGOT TO
MENTION THERE IS PAIN IN THIS
POPULATION AND PRETTY SEVERE
PAIN AND OSTEOMILITIS AND
PAINFUL SURGERIES AND SO FORTH
AND TO NORA'S POINT ABOUT
CROSS-CUTTING ISSUES AND LOTS OF
PAIN MANAGEMENT ISSUES TO
CONSIDER ALONG WITH ADDICTIONS.
>>RIGHT. WE WILL INCORPORATE
THAT AS WELL.
ALL RIGHT. THANKS FOR WONDERFUL
FEEDBACK AND TURNING THE NEXT
OVER TO YOU, TISHA. TAKE IT
AWAY.
>>GREAT. NEXT SLIDE. THIS
NEXT ONE IS ANOTHER SPECIAL
POPULATION THAT NEEDS ATTENTION
THAT WE TALKED ABOUT THIS AT
DIFFERENT POINTS I THINK WITH
THE GROUP BEFORE. THIS IS ABOUT
CHILD-WELFARE SYSTEM AND HOW IT
RESPONDS SPECIFICALLY TO
POSTPARTUM WOMEN AND WHAT
HAPPENS TO FAMILIES EITHER AFTER
THE CHILD IS BORN IN TERMS HOW
OUD IS DEALT WITH AND THIS IS
ABOUT PROVIDING COMPREHENSIVE
SERVICE MODELS DESIGNED
HOPEFULLY WITH GOAL OF FAMILY
REUNIFICATION OR STABILITY
WHEREVER IT IS POSSIBLE AND
REALLY MAKING SURE THAT THESE
FAMILIES THAT THE PARENT HAS
ACCESS TO APPROPRIATE CARE
INCLUDING MEDICATIONS FOR OPIOID
USE DISORDER AND HEARD SEVERAL
ANECDOTES CHECKING IN WITH
COLLEAGUES AT SAMHSA. IT IS
TRUE IN THE FIELD THERE IS
STIGMA FOR OPIOID USE DISORDER
AT TIMES PARENTS ARE GIVEN
CHOICE FOR -- TO BE REUNIFIED
FOR FAMILIES THAT PUTS THEM AT
RISK FOR FURTHER
DESTABILIZATION. THE GOAL HERE
IS REALLY BRINGING IN
INTERVENTIONS AND EVIDENCE-BASED
SERVICE DELIVERY MODELS TO
SUPPORT APPROPRIATE CARE AND
HOPEFULLY LEAD TO BETTER
OUTCOMES FOR THE FAMILIES
OVERALL.
AND YOU KNOW, THERE IS A LOT OF
PARTNERSHIPS THAT ARE PART OF
HOW THIS GOES AGAINST PUTTING IT
TOGETHER INCLUDING RECOVERY
APPROACHES AND OTHER ELEMENTS
AND WE HAVE HAD CONVERSATIONS
WITH SAMHSA AND ACSF AND VIEW
THEM AS KEY PARTNERS GIVEN THEIR
RELEVANT WORK IN THIS AREA.
NEXT SLIDE, PLEASE.
I THINK THAT I KNOW THAT IS VERY
BRIEF.
I THINK ISSUES ARE SO COMPELLING
FOR THIS POPULATION AND WE KNOW
THAT IS NOT HOW CARE IS GETTING
DELIVERED TO FAMILIES AND YOU
KNOW THIS EFFECTS CHILDREN'S
DEVELOPMENT AND IT EFFECTS THE
PARENT AND HAS SUCH IMPORTANT
IMPLICATIONS.
I THINK IT IS A REALLY IMPORTANT
TOPIC TO FOCUS ON. I WILL OPEN
IT UP FOR DISCUSSION.
>>WELL, I WILL SAY THAT I -- I
THINK THAT, YOU KNOW, ONE OF THE
MOST EXCITING THINGS ABOUT THIS
TO ME IS THIS ATTEMPT TO BREAK
DOWN THIS -- THESE SILOS.
THEY ARE KIND OF WORKING AGAINST
US WITH REGARDS TO HAVING EVER
VERY INTEGRATED OR REALLY
INTEGRATED HEALTH CARE SERVICES
AND TRANSLATIONAL, YOU KNOW,
PROGRESS OF TRANSLATIONAL
MEDICINE AND THINK THIS IDEA
THAT WE CAN WORK TOGETHER ACROSS
DIFFERENT AGENCIES AND KIND OF
HARMONIZE AND, YOU KNOW, KIND OF
SORT OF SIN ERNLIZE IN DIRECTION
IS EXCITING BREAKING DOWN SILOS
THAT ARE IMPEDING PROGRESS AND
KUDOS TO YOU FOR DOING THAT.
>>THANK YOU. I THINK WE CAN
BUILD A LOT ON LESSONS WE HAVE
LEARNED IN WORKING IN THE
JUSTICE SPACE AND CHALLENGES ARE
SIMILAR TO WHAT WE HAVE SEEN
HISTORICALLY AROUND OFFERING
MEDICATIONS IN THE JUSTICE
SPACE. YOU ARE SEEING A SIMILAR
KIND OF DYNAMIC IN THE CHILD
WELFARE SPACE.
>>RECORDING STOPPED.
RECORDING IN PROGRESS.
>>I SEE NORA'S HAND.
>>I WANT IT TO BE FIRST SURE
THERE WAS NOT A PLANNED
DISCUSSANT BEFOREHAND.
BEFORE I ACTUALLY BRING FORWARD
IF THERE IS NOT.
WHAT I WANTED TO COMMENT IS THIS
IS AN AREA WITH HORRIFIC NEGLECT
AND TRYING TO GET INFORMATION
WHAT RESEARCH HAS BEEN DONE ON
CHILD WELFARE SYSTEMS AND
OUTCOMES OF CHILDREN ACTUALLY
SENT TO FOSTER CARE BECAUSE OF
USE OF DRUGS.
TO MY DISMAY, IT IS BASICALLY
NOTHING.
SO, WE HAVE GUIDELINES.
I MEAN THAT ARE BASICALLY NOT
BASED ON ANY SOLID EVIDENCE
ABOUT WHAT ARE THE OUTCOMES OF
THESE CHILDREN THAT ARE SENT OUT
TO FOSTER CARE. MIND YOU, NO. 1
REASON WHY CHILDREN ARE SENT TO
FOSTER CARE IS BECAUSE OF USE OF
DRUGS BY THE PARENTS.
SO, THIS IS AN AREA THAT
DESERVES RESEARCH URNLIENTLY AND
NOT JUST TO SAY IN TERMS OF
ACTUALLY WHICH IS VERY IMPORTANT
WHAT MODELS CAN MINIMIZE
LIKELIHOOD WHEN A MOTHER HAS AN
INFANT AND IS TAKING DRUGS THAT
THEY WILL BASICALLY GET INTO
TREATMENT AND STAY IN TREATMENT
AND MINIMIZE LIKELIHOOD THAT
THEY WILL LOSE THAT CHILD.
ALSO, IMPORTANTLY, WHAT ARE
OUTCOMES OF THE DIFFERENT
OUTCOMES THAT DECISIONS ARE
BEING MADE BY THE STATES?
BECAUSE THAT SHOULD BE A
GUIDELINE IN TERMS OF WHAT MAY
BE A RECOMMENDATION.
OTHERWISE, WE ARE IN COMPLETE
DARKNESS.
ONES THAT SUFFER, OBVIOUSLY,
THEY ARE CHILDREN AND MOTHERS.
THIS BECOMES AN EVEN GREATER
STRESSOR.
SO, I WOULD BE VERY INTERESTED
ON HERE HOW WE TAKE THIS AHEAD.
HOW DO WE CONSOLIDATE A RESEARCH
PLAN THAT WILL GIVE YOU OR START
TO PROVIDE THIS KNOWLEDGE.
>>I ABSOLUTELY AGREE WITH YOU,
NORA.
I SEE ANDREA ALSO HAS HER HAND
UP.
>>NO. I APPLAUD NORA. THANK
YOU SO MUCH FOR SAYING THOSE
COMMENTS AND ALSO FOR YOUR BLOG
THAT YOU WROTE ABOUT THIS VERY
INCREDIBLY TOPIC THAT HAS
GENERATIONAL IMPACT. I WOULD
ALSO LIKE TO ADD I KNOW WE FOCUS
ON THE MOTHER AND ALSO TO CAST A
WIDE NET.
THERE IS MANY FATHERS OUT THERE
THAT WOULD ALSO LIKE TO BRING
THEIR CHILDREN TO TREATMENT.
AND THEY WOULD LOSE THEIR
PARENTAL RIGHTS.
SO, YOU KNOW, WHERE ARE
EVIDENCE-BASED MODELS AND DIAD
THAT IS A PATERNAL CHILD DIAD IN
ADDITION TO MATERNAL CHILD
[INDISCERNIBLE]. THAT IS
INCREDIBLY IMPORTANT THAT I
CAN'T UNDERSCORE INCREDIBLE
VARIATION IN THE WAY THAT CHILD
WELFARE RESPONDS ABOUT I COUNTY.
IN THE UNITED STATES.
SO, I KNOW THAT EVERY STATE IS
DIFFERENT. SOME STATES HAVE
MORE STATE CONTROL.
AT LEAST IN MANY STATES
INCLUDING THE STATE I'M IN IS
COUNTY DRIVEN AND WE HAVE 100
COUNTIES AND THINGS ARE DONE
LITERALLY 100 DIFFERENT WAYS AND
WE DESPERATELY NEED
EVIDENCE-BASED GUIDELINES FOR
SCREENING HOW TO DETERMINE RISKS
OR SAFETY RISKS FOR CHILDREN AND
FOR PARENTS AND TO HAVE
SYSTEMATIC TRAINING WHAT IS A
SUBSTANCE USE DISORDER WHERE
TREATMENT IS AVAILABLE FOR OUR
CHILD WELFARE WORKERS.
THEY HAVE A TREMENDOUSLY
DIFFICULT JOB THAT THEY HAVE TO
DO. THEY OFTEN GET LITTLE
TRAINING IN, YOU KNOW, ADDICTION
OR IN SUBSTANCE USE DISORDERS.
YOU KNOW, JUST USING THIS
OPPORTUNITY TO STANDARDIZE AND
LEARN AS MUCH AS WE CAN TO
STANDARDIZE BASED ON EVIDENCE
AND ALSO TO NOT FORGET THERE ARE
MANL STRAIGHTS OUT THERE.
THERE ARE DIFFERENT COURT
PROGRAMS SO INTERTWINING OF YOUR
JUDICIAL SYSTEM AND CHILD
WELFARE IS INEXTRICABLY LINKED
AND YOU CAN'T LOOK AT ONE
WITHOUT THE OTHER AND MAKING
SURE WE LEARN FROM ALL DIFFERENT
STAKEHOLDERS ALLOWING
INTERVENTIONS TO HAPPEN IN ALL
OF THE DIFFERENT PLACES WHERE,
YOU KNOW, FAMILIES INTERSECT
WITH THE CHILD WELFARE SYSTEM.
THANK YOU FOR GIVING THIS. I'M
EXCITED ABOUT IT.
>>THANK YOU, ANDREA. MICHELLE
REMINDED ME HER GROUP HAS BEEN
ORGANIZING IN RELATIONSHIP TO
HBCD AND WORKSHOP ON ENGAGING
CHILD WELFARE SYSTEMS HAPPENING
IN MAY AND DEVELOPER OF THIS
CONCEPT HAS BEEN WORKING WITH
MICHELLE AND HER TEAM IN DOING
THAT. THAT IS HEAL SUPPORTED.
YOU KNOW, ALL OF THE COMPLEXITY
OF ISSUES YOU ARE HIGHLIGHTING
ABOUT DIFFERENT STAKEHOLDERS
THAT NEED TO ENGAGED AND WAY
THAW THINK ABOUT IT AND
COMPLEXITY OF, YOU KNOW, FAMILY
DYNAMICS EXTENDING BEYOND FOCUS
ON MATERNAL COMPONENTS AND ALSO
PARENTS AND SORT OF THE WHOLE
FAMILY. OFTEN THESE ARE
MULTIGENERATION. YOU KNOW,
CHILDREN ENTER FOSTER CARE
SYSTEM TOO AND YOU ARE TALKING
ABOUT MULTIGENERATIONAL HOMES
AND LOTS OF COMPLEXITIES THERE
AS WELL.
BECAUSE -- ANYWAYS, THANKS FOR
HIGHLIGHTING ALL THOSE ISSUES
NEEDING TO BE ATTENDED TO.
>>ONE MORE THING GLAD MICHELLE
IS HAVING A MEETING IN MAY. WE
ARE DOING BIOETHICS AND MAKING
SURE WE ARE NOT INADVERTENTLY
CREATING HARM AND MORE PEOPLE
ARE LOOKING AT FAMILIES AND
CHILDREN AND MAKING SURE WE ARE
BALANCING RISK AND BENEFIT FOR
EVERYBODY. THANK YOU.
>>THANK YOU.
>>GAIL?
>>I WAS JUST GOING TO BRING UP
THIS IS WONDERFUL.
IT IS WONDERFUL NEEDED WORK.
WE ALSO HAVE TO BE CAREFUL ABOUT
MEDICATIONS WE ARE PRESCRIBING.
AGAIN, I HAVE SPOKEN WITH WOMEN
WHO IN DIFFERENT STATES IT IS
RUN BY THE STATE CAN ONLY USE
MENLO DON'T AND HAVE TO GET TO
THE MENLO DON'T CENTER AND THEY
CAN'T. THERE ARE MANY DESERTS
WHERE METHO DON'T PLACES ARE.
THERE WERE SO MANY BARRIERS THAT
THERE WAS NO WAY THAT MOTHER
COULD TAKE CARE OF A CHILD AND
HAD ANOTHER CHILD PARTICULARLY
AT HOME COULD GET ON A BUS AN
HOUR A DAY OR BACK AND WEREN'T
OFFERED NOREPINEPHRINE AND WERE
OFFERED MENLO DON'T DURING
PREGNANCY AND WE CAN'T
TRANSITION THEM WELL DURING
PREGNANCY. IT IS A MATTER OF
THAT AND EXPANDING TELEHEALTH
AND OPTIONS THAT HAPPENED DURING
COVID THAT EVERYONE THAT IS
FRIGHTENED WILL GO AWAY. WE
HAVE TO DO THIS FOR NO. 1 IS
THEY DON'T HAVE ACCESS TO
MEDICATIONS VERY EASILY BEING A
MOM. I WANTED TO JUST MAKE SURE
THAT WE DIDN'T FORGET THAT. I
WANTED TO SAY THESE ARE
MEDICATIONS THAT ARE NOT ONLY
EFFICACIOUS BUT WILL BE MORE
LIKELY TO ENGAGE A MOM THAN
SOMETHING THAT WILL REQUIRE SO
MUCH REGULATORY PROBLEMS IN
TRANSPORTATION, ET CETERA.
>>I THINK THAT IS A SUPER
IMPORTANT POINT. I THINK TOO
UNDERSTANDING FROM THE
PERSPECTIVE OF SYSTEM AND
AVAILABILITY OF SERVICES IN THE
COMMUNITY I'M SURE THERE ARE
MANY CASES AND KNOW FROM WORK I
DID EARLIER IN MY CAREER THAT
PEOPLE WERE EFFECTED BY
NONEFFECTIVE TREATMENTS
AVAILABLE IN THE COMMUNITY AND
KEEPING IN MIND PEOPLE ARE BEING
OFFERED THINGS BOTH EFFECTIVE
AND ACCESSIBLE.
SUCH A GREAT POINT.
>>ALL RIGHT, TISHA.
WE HAVE ONE MORE.
>>OKAY. 6TH ONE IS A LITTLE
BIT IF WE CAN GO TO THE NEXT
SLIDE. IT IS A LITTLE DIFFERENT
FROM THE OTHERS AND INSTEAD OF
FOCUSING ON A POPULATION GAP.
THIS IS MORE ABOUT SORT OF HOW
DO WE TRANSLATE OUR FINDINGS
BACK OUT INTO PRACTICE.
SO, HERE ARE THE IDEAS THAT ARE
REALLY ABOUT ENGAGING WITH KEY
DECISION MAKERS OUT IN THE FIELD
AND BUILD INFRASTRUCTURE TO
SUPPORT COLLABORATIONS BETWEEN
RESEARCHERS AND DECISION MAKERS
AND SO IN PUBLIC HEALTH LEADERS
AND WHEN I SAY DECISION MAKERS
AND PUBLIC HEALTH LEADERS I MEAN
PUBLIC HEALTH COMMISSIONERS AND
SINGLE STATE -- OPIOID RESPONSE
AND HEARING ABOUT ABATEMENT
COUNCILS. CAN YOU THINK OF
CLINICAL TREATMENT DIRECTORS AND
AGENCIES AND PEOPLE THAT END UP
AND EARLIER YOU MENTIONED
HOSPITAL ADMINISTRATORS THAT ARE
PEOPLE THAT ULTIMATELY END UP
MAKING DECISIONS ABOUT HOW
VARIOUS RESOURCES GET ALLOCATED
AND IDEA IS HOW DO WE BRIDGE
WHAT THEIR NEEDS ARE AROUND
UNDERSTANDING AND USING RESEARCH
AND APPLYING RESEARCH IN CONTEXT
OF THEIR RESPONSIBILITIES AND
HOW CAN WE BUILD RESEARCH
INFRASTRUCTURE TO SUPPORT THAT.
SO, THIS WOULD BE A LITTLE MORE
OF AN UNUSUAL MECHANISM AND
REALLY PROOF OF CONCEPT HOW YOU
DO THIS. WE KNOW IN PORTFOLIOS
THAT SOMETIMES WE SEE
APPLICATIONS THAT WILL COME IN,
IN A FEW PLACES THAT HAVE STRONG
INFRASTRUCTURE. WE MIGHT SEE
THIS IS ALSO ABOUT BUILDING
CONNECTIONS ACROSS JURISDICTIONS
.
WE SOMEHOW SEE THINGS COMING IN
WITH A SINGLE STATE WITH REALLY
ROBUST INFRASTRUCTURE THAT IS
HARD TO REPLICATE THAT AND IDEA
HERE IS TO START TO REALLY
FIGURE OUT HOW WE SCALE THAT
INFRASTRUCTURE AND CREATE A
SYSTEM WHERE WE CAN HAVE LESSONS
LEARNED FROM ONE SYSTEMS TRANCE
LAETDED TO ANOTHER. NEXT SLIDE,
PLEASE
I THINK THIS IS THE LAST MILD
GAP IN THE TRANSLATION
CONTINUUM.
SO, YOU KNOW, I THINK THIS
COMPLEMENTS WORK THAT WE HAVE
DONE WITH HEALING COMMUNITIES
AND DATA TO ACTION THAT IS
REALLY ABOUT BUILDING THIS
INFRASTRUCTURE MORE BROADLY AND
FIGURING OUT WHAT BARRIERS TO
DOING THAT WOULD BE.
AND, YOU KNOW, IT WOULD BE A
MECHANISM THAT WOULD GIVE US
SPACE TO FIGURE IT OUT A LITTLE
MORE. NEXT SLIDE, PLEASE.
SO, I THINK THAT I COULD OPEN IT
UP TO QUESTIONS FROM THERE.
>> JUST A COMMENT. I THINK
THAT THE IDEA THAT WE WILL BE
ABLE TO -- TO DO TRANSLATIONAL
WORK LIKE THIS WITHOUT RESEARCH
PARTNERSHIPS IS RIDICULOUS.
THIS IS A REALLY IMPORTANT KIND
OF RESEARCH PRACTITIONER
PARTNERSHIP HAVING TO BE PUT IN
PLACE FOR DECISIONS TO BE MADE
BASED ON EVIDENCE.
I THINK, YOU KNOW, IT IS A
NO-BRAINER. IF WE DON'T HAVE
INFRASTRUCTURE WE WILL BUILD IT
SOMEHOW THAT IS A BEGINNING TO
START TO BUILD THOSE DECISION
MAKERS THAT ARE PRACTITIONERS
HERE. YOU HAVE TO REALLY HAVE
THAT LINK BETWEEN RESEARCHER AND
PRACTITIONER AND WE DON'T HAVE
IT NOW A VERY GOOD LINK THERE.
IT SEEMS OBVIOUS THAT IS A PLACE
THAT HAS TO BE ADDRESSED.
SO --
>>WE AGREE.
THE HOW IS THE HARD PART. I
THINK THAT WE HAVE TO START TO
TRY THINGS THAT WE HAVEN'T TRIED
BEFORE.
>>RIGHT.
>>NORA?
>>TO ME SAYING WITH HOW AND I
SAY THAT THERE ARE MANY HOWS AND
KEY HOW AND CRUCIAL HIGH AND HOW
WE CAN BUILD UPON IS DATA AND
ACCESS TO DATA.
SO, WE WERE JUST DISCUSSING
ISSUES OF CHILD WELFARE TO
EXTENT THAT WE START TO COLLECT
LARGE DATA BASES INFORMING US
HOW A PARTICULAR INTERVENTION
UNDER CERTAIN CONDITIONS
RESULTED TO AN OUTCOME AND WHAT
ARE COSTS ASSOCIATED WITH IT.
WE START TO BUILD THAT
INFRASTRUCTURE.
SO, THAT INFRASTRUCTURE IS
FUNDAMENTAL AND I THINK THAT WE
SHOULD PULL OUR HEADS TOGETHER.
WE CAN FIGURE OUT THAT OBVIOUSLY
ONE OF THE KEY ELEMENTS IS TO
GENERATE DATA BASES THAT BECOME
INTEROPERABLE WITH ONE ANOTHER
AND INTEGRATED SUCH THAT I CAN
PULL THEM AND GAIN MORE
INFORMATION THAN WHEN THEY ARE
IN ISOLATION.
SO, IF WE SAY WITHIN -- WHAT
WOULD WE NEED TO DO?
WITH DATA BASES THAT ARE
RELEVANT THAT WE ARE COLLECTING
TO ENSURE THAT THIS INFORMATION
WILL BE -- WE WILL BE ABLE TO
PULL IT UP TO GUIDE EXACTLY WHAT
YOU ARE TRYING TO DO TO
FACILITATE TRANSLATION OF
EVIDENCE INTO THE PRACTICE.
SO, I THINK THAT THIS IS ONE OF
THE IMPORTANT HOWS THAT I WOULD
SUGGEST THAT WE TAKE ADVANTAGE
OF.
WE ARE ALREADY BUILDING INTO THE
DATA BASE SPACE.
>>YEAH. ONE POINT INSPIRATION
FOR THIS IS JULIE DONAHUE HAS A
NICE GRANT PULLING TOGETHER
MEDICAID DIRECTORS FROM MULTIPLE
STATES USING A DISTRIBUTED
ANALYSIS APPROACH THAT ALL OF
THE MEDICAID DATA IS HARD TO PUT
TOGETHER AND THEY WANT TO
MAINTAIN CONTROL OF LOCAL DATA
AND COME UP WITH SHARED
QUESTIONS AND RUN SIMILAR
ANALYSES AND COME BACK AND TALK
ABOUT THE RESULTS.
OUR HOPE IS TO USE MECHANISM TO
FIND OUT CREATIVE SOLUTIONS LIKE
THAT, THAT ARE OF INTEREST AND
ACCESSIBLE AND WHAT
INFRASTRUCTURE WE HAVE TO BUILD
TO RESPOND TO THE SORT OF
BARRIERS THAT THEY MIGHT
EXPERIENCE OR WHAT NEEDS ARE AND
JUST THIS IS REALLY MEANT TO BE
A FOUNDATIONAL INITIATIVE TO
JUST FIGURE OUT THE ROADMAP FOR
THE HOW BY DISCUSSING THOSE
KINDS OF QUESTIONS.
>>ANDRÉ?
>>I HAD A SMALLER COMMENT.
THAT IS AS I LOOKED THROUGH THE
DOCUMENTATION THAT YOU SENT ONE
KEY LEADER GROUP THAT WAS NOT
MENTIONED THERE IS ANY KIND OF
PATIENT ADVOCACY OR
PATIENT-LIVED EXPERIENCE GROUPS
AND THINKING ABOUT INCLUDING
THOSE GROUPS AT SOME POINT WHERE
IT MAKES SENSE. THEY ARE END
USERS AND FOR IT TO WORK THEY
HAVE TO REALLY HAVE BUY-IN TOO.
>>I THINK YOU ARE ABSOLUTELY
RIGHT WE HAVE THINGS DUE AND
THINKING ABOUT ALL THAT AND HOW
IT ENDS UP FITTING TOGETHER AT
THE END.
>>ANY OTHER THOUGHTS OR
COMMENTS ABOUT THIS SPECIFIC
CONCEPT?
I THINK IF NOT WE CAN KIND OF
OPEN IT UP TO ALL OF THE FLOOR
THAT WE HEARD ABOUT. AND WE CAN
DISCUSS JUST KIND OF THE GENERAL
LEVEL OF ENTHUSIASM AND THOUGHTS
AND FEEDBACK ABOUT THIS GROUP OF
PROPOSED RESEARCH.
THERE IS COMMONALITIES
ESPECIALLY AT THE BEGINNING
AROUND POPULATIONS AND SOME
FACTORS THAT WE WANT TO
CONSIDER. IF YOU HAVE HIGHER
LEVEL FEEDBACK OR THOUGHTS NOW
WOULD BE THE TIME TO SHARE.
I HAD ONE COMMENT THAT I WANT
BEFORE WE LEFT THAT LAST CONCEPT
THAT IS ONE CHALLENGE HERE IS TO
TRY TO QUICKLY FOCUS ON A WAY OF
GETTING BUY-IN FOR US TO HAVE
SUSTAINED -- A SUSTAINED LEVEL
OF INTERACTION BETWEEN DECISION
MAKERS AND RESEARCHERS AND
BIGGEST PROBLEM HAPPENING WITH
RESOURCES IS THERE IS A
SHORT-TERM THING THAT IS
INTERESTING TO PEOPLE AND PEOPLE
HAVE NOT FOUND THEIR STRIDE YET
THEN IT GOES AWAY. I THINK JUST
AN EARLY FOCUS ON HOW TO SUSTAIN
INTERACTIONS BETWEEN RESEARCH
COMMUNITY AND DECISION MAKERS
OVER TIME TO -- TO FIND THE
PARTNERS WHO ARE REALLILE TO
COMMIT TO A LONGER TERM AND HELP
TO CREATE, YOU KNOW, RESOURCES
FOR A LONGER TERM INTERACTION
WILL BE IMPORTANT IN TERMS OF
GETTING SUCCESS WOW LIKE TO SEE
FROM THIS INTERACTION.
IT WILL TAKE LONGER TERM
COMMITMENT TO IT. THERE WILL BE
PARTNERS WHO WILL BE VERY MUCH
INTERESTED IN CONTRIBUTING TO
LONGER TERM COMMITMENT. THEY
HAVE TO BE ENGAGED EARLY ON AND
LOT OF STRATEGIES FOR DOING
THAT. I THINK IT WILL BE A
CRITICAL PART OF MAKING THIS
SUCCESSFUL IS A LONGER TERM
COMMITMENT.
>>THANK YOU. WE WILL
DEFINITELY GIVE IT THOUGHT ABOUT
HOW TO MAKE IT HAPPEN.
>>I HAVE A QUICK COMMENT TO
JUST APPLAUD ALL OF YOU ON THIS
WORK AND HAVING COURAGE TO TAKE
THAT TRANSLATIONAL STEP
BEGINNING TO TACKLE SOME MAJOR
SYSTEMIC SYSTEMATIC ISSUES TO BE
ADDRESSED AND CAN'T WAIT FOR
PAIN SPACE TO GET HERE AS WELL A
LITTLE BIT. HOPEFULLY IF YOU
CAN TACKLE THIS AND KNOCK DOWN
SOME BARRIERS WE CAN LEARN FROM
YOU AND THANK YOU SO MUCH FOR
DOING THIS VERY HARD WORK THAT
HAS A HEAVY LIFT.
>>EXACTLY THE SAME THOUGHT AND
DEFINITELY IN THE PAIN SPACE.
>>THANK YOU FOR THAT COMMENT.
WE CAN CERTAINLY LOOK FOR, YOU
KNOW, THIS IS SOMETHING THAT WE
CAN LOOK FOR CONNECTION POINTS.
>>I GUESS I PUT THE QUESTION IN
THE CHAT. IT MAY SEEM ALMOST
RHETORICAL.
BUT, WHAT THE ISSUE OF PAIN
OBVIOUSLY IS WHAT CAUGHT MY
ATTENTION.
SO, I'M WONDERING TO WHAT EXTENT
THERE IS A CHICKEN AND EGG THING
HAPPENING HERE. YOU HAVE AN
INDIVIDUAL WITH A PAIN PROBLEM
WHO THEN IS EITHER TAKING OP
OPIATES OR USING ALCOHOL AND
THEY HAVE ALCOHOL AND BECOME OR
MISUSE ALCOHOL AND PAIN
CONDITION DEVELOPS.
THEN THE FACTOR OF ANL.
AN ADULT WITH A PAIN PROBLEM
BECAUSE THEY ARE AN ADULT
OPPOSED TO A KID. I'M TALKING
ABOUT A TEENANLER.
SO, IS -- IS PAIN SECONDARY TO
USE OF THE DRUG?
IS IT INDEPENDENT AND TWO
ENHANCE EACH OTHER OR IS THAT
KNOWN OR EXAMINED?
>> YEAH. THAT IS KNOWN. I
MEAN, I THINK THERE IS A LOT OF
WORK THAT HAS BEEN PUBLISHED NOW
FOR MANY YEARS THAT HAVE
INITIALLY INDICATED MUCH HIGHER
PREVALENCE OF PAIN AMONG
INDIVIDUALS WITH VARIOUS CLASSES
OF SUBSTANCE USE DISORDERS AND
RESEARCHERS HAVE ACTUALLY BEEN
LOOKING AT WHETHER IN FACT
ANIMAL MODELS OF PAIN ADDING FOR
EXAMPLE ALCOHOL THAT MAYBE HAS
BEEN ONE THAT IS INVESTIGATED OR
STIMULANT DRUGS THAT CAN
EXACERBATE IT. AS YOU KNOW AND
ARE MENTIONING CERTAINLY WITH
OPIOIDS THAT YOU HAVE THE
EMERGENCE OF I PARAGEEZ YA AND
FROM THE PERSPECTIVE OF NEUROBUY
OL, THERE IS RESEARCH IT THAT IS
TRYING TO UNDERSTAND AND HOW IS
IT THAT DRUGS MAY BE
ACCELERATING THE PROCESS OF PAIN
FROM THE PERSPECTIVE OF
NEUROPLASTICITY IS EXTREMELY
INTERESTING AS YOU LOOK FOR
EXAMPLE AT TRANSITION FROM ACUTE
TO CHRONIC PAIN AND WHERE YOU NO
LONGER HAVE TRAUMA OF PAIN THAT
IS ALREADY IN PRESENCE. WE ARE
FUNTDING RESEARCHERS TO LOOK AT
WHETHER ONE EFFECT OF DRUGS THAT
IS TO ACTUALLY ACTIVATE
NEUROAXIS COULD BE A MECHANISM
THAT ACCELERATE TRANSITION.
THAT IS A EXAMPLE OF THE SCIENCE
FROM THE NEUROSCIENCE
PERSPECTIVE. BUT, IT --
PEOPLE THAT HAVE TAKEN DRUGS END
UP WITH PAIN BECAUSE OF THE
EFFECT OF DRUGS OR THE LIFESTYLE
THAT PUTS YOU -- TO PAIN. SO,
BUT IT IS A FUNDAMENTAL ONE AND
INTERESTINGLY ONE THAT IS NOT
NECESSARILY AT ALL RECOGNIZED BY
CLINICIANS AND THAT VERY CLOSE
INTERACTIONS BETWEEN PAIN AND
SUBSTANCE USE DISORDERS AND BY
THE WAY ALSO MENTAL ILLNESS THAT
IS PARTICULARLY MOOD DISORDERS
AND HIGH, HIGH PREVALENCE OF
PAIN.
>>THANK YOU.
>>GAIL, WOULD YOU ADD TO THAT?
>>ACTUALLY, NORA JUST SAID TO
ME THAT PAIN IS THE MENTAL
HEALTH DISEASE THAT WE SEE MOST
OFTEN. WE OBVIOUSLY SEE PEOPLE
WHO HAVE PAIN AND USED
POPULATION OF HOMELESS
INDIVIDUALS THAT ARE OUTSIDE OF
THE -- ALL KINDS OF INJURES, ET
CETERA, THAT MAKES A MESS,
ACTUALLY, IN TRYING TO DEAL WITH
ALL THEIR ISSUES AND MENTAL
HEALTH ISSUES ARE BY FAR
OUTWEIGHING THE PHYSICAL PAIN
THAT WE SEE.
IT IS NOT JUST THE TYPICAL
MENTAL HEALTH THAT ONE WOULD
THINK BUT IS DESPAIR AND
COGNITIVE DELAYS THAT OFTEN
CHILDREN HAVE FOR A VARIETY OF
DIFFERENT REASONS OR ADHD OR
DELAYS AND THERE IN THE STREET
AND THEY GET TAKEN OVER BY THE
-- WHATEVER.
SO, TO TRULY NEVER SEEN SUCH A
MESS AND I DON'T MEAN TO BE
PESSIMISTIC. I HAVE NEVER SEEN
SO MUCH MENTAL DISEASE OR MANY
MENTAL HEALTH DISEASE OR DESPAIR
ACTUALLY IN 30-SOME YEARS IN
WORKING IN MRNL DEPARTMENTS THAT
ARE HAPPENING NOW.
FIXES, YEAH. I CAN GIVE YOU
MEDICATIONS TO DO IT. I CAN'T
FIX THE REST.
THAT IS WHERE WE REALLY -- WE
ARE REALLY FALLING DOWN ON.
BECAUSE EVEN WHERE I AM IN NEW
HAVEN AND YOU THINK I WOULD HAVE
RESOURCES FOR MENTAL HEALTH, I
DON'T. I HAVE A [INDISCERNIBLE]
FULL OF PATIENTS JUST SITTING
THERE DAY AFTER DAY. ALL WE DO
IS SAY OKAY. THEY ARE NO LONGER
SUICIDAL. THIS AIS IT,
ESSENTIALLY.
I WAS GOING TO SAY AS WELL
MENTAL HEALTH ISSUES ASSOCIATED
WITH THIS HAVE TO BE ADDRESSED
AND OTHER COMMENT ON THIS IS
RESOURCE NETWORKS IN ADVANCING
AND THERE IS LOTS OF MONEY THAT
SAMHSA GIVES AWAY TO STATES AND
LOTS OF STATE-FUNDED THINGS BUT
NONE OF THEM STAY.
WE REALLY HAVE TO MAKE SURE THAT
WHOEVER IS GETTING THIS MONEY
HAS A DIRECT REASON THAT THEY
WILL BE ABLE TO BE SUSTAINABLE
AND THEY HAVE TO GET THAT OKAY.
I DO FIND THOUGH THAT ONCE YOU
GET THE MONEY, I KEEP A SCRAP
BOOK OR TELL EVERYBODY TO KEEP
SCRAP BOOKS. IT IS NOT RESEARCH
BUT ACTUALLY GOING OUT TO
ADVOCACY GROUPS AND IT IS
TEACHING EVERYBODY IN THE
HOSPITAL AND I ASK CERTAIN MEDIA
REPRESENTATIVES FOR PEOPLE IN
NEW HAVEN WOULD YOU RUN AN
ARTICLE ON THIS SO WE CAN SHOW
WHAT WE ARE DOING. WE ARE
CONSTANTLY FROM THE VERY
BEGINNING REALIZING THAT WE HAVE
TO KEEP THIS GOING SO NO ONE
WILL TAKE THESE RESOURCES AWAY.
TOO OFTEN I HEAR ALL OVER THE
PLACE THAT THESE SERVICES WILL
BE SHUT DOWN BECAUSE FUNDING IS
OVER.
I THINK THAT WE HAVE TO DO A
BETTER JOB SAYING NO YOU WON'T
GET FUNDING TO BEGIN 1LESS YOU
GIVE ME A PLAN HOW THIS WILL
MOVE FORWARD.
>>THOSE ARE VERY GREAT POINTS,
GAIL. TAKING US TO EARLIER
POINTS AROUND SUSTAINABILITY AND
THINK THAT ONE OF THE REASONS
WHY, YOU KNOW, WE INCLUDED SSD
LEADERS AND PEOPLE THAT WE
THOUGHT ABOUT THAT REGARDLESS
WHAT THEIR RESOURCES ARE
ULTIMATELY ROLE IS HOW YOU
ALLOCATE WHAT RESOURCES ARE
AVAILABLE THAT I THINK WOULD
HELP THAT APPROACH WOULD HELP
ADDRESS SUSTAINABILITY EVEN AS
SOURCE OF THE RESOURCES CHANGES
OR AS IT GOES UP OR DOWN THESE
ARE PEOPLE THAT HAVE TO DECIDE
HOW IT WILL ALLOCATE WHAT IS
AVAILABLE AND THINK IT IS WHY WE
THOUGHT IT WAS IMPORTANT TO
TARGET THAT PARTICULAR KIND OF
RO
ROLE.
>>WELL, TERRIFIC DISCUSSION.
THANK YOU, TISHA AND WENDY AND
TO THE DISCUSSANTS AND TO
EVERYONE WHO JOINED. THIS IS A
REALLY EXCITING PART. IF YOU
CAN SEE THE REALLY INTERESTING
AND IMPORTANT WAYS THAT IT
CONTINUES TO EVOLVE RELEVANT TO
THE MENTAL HEALTH ISSUES THAT
GAIL AND OTHERS JUST RAISED.
WE CAN MOVE TO THE NEXT SECTION
OF THE AGENDA AND WE HELD OUR
DISCUSSION
ONE MORE SLIDE, PLEASE.
WE FOCUS ON RESEARCH TO DEVELOP
NEW STRATEGIES TO PREVENT AND
TREAT OPIOID ABUSE ADDICTION AND
DISORDER AND HAVE ON BEHALF OF
NATIONAL INSTITUTE OF MENTAL
HEALTH DR. ALEX WHO WILL WALK US
THROUGH CONCEPTS PROPOSED BY THE
TEAM AND JUST MAKE A QUICK
STATEMENT THAT SOME OF THESE ARE
TRIALS TO BE RUN THROUGH THE
NIDA CLINICAL TRIALS NETWORK. I
ASK THOSE ON THE
MULTI-DISCIPLINARY WORKING GROUP
ASSOCIATED WITH THAT NETWORK TO
BE AWARE OF THAT AS YOU
PARTICIPATE IN THE DISCUSSION
AND ANY POTENTIAL CONFLICTS
THERE. NEXT SLIDE, PLEASE.
HERE, WE HAVE, AGAIN, THIS
VISUAL DEPICTION OF RESEARCH
UNDERWAY THROUGH THIS ASPECT OF
HEAL. THE MANY, MANY, MANY
TRIALS BEING RUN THROUGH NIDA
CLINICAL TRIALS NETWORK AND
FOCUS ON MENTAL HEALTH STARTING
AT THE VERY BEGINNING IN TERMS
OF MODELS OF CARE.
ALSO, INVOLVEMENT OF OTHER
ASPECTS OF PERSON'S HEALTH
INCLUDING SLEEP AND SOCIAL
DETERMINANTS AND AT VERY BOTTOM
HERE, YOU CAN SEE WHAT HAS BEEN
PUT FORWARD OR PROPOSED BY THE
TEAM FOR FUTURE RESEARCH
STARTING IN FISCAL YEAR 2024.
THERE IS FOUR DIFFERENT STUDIES
THAT WILL BE DISCUSSED. WITH
THAT, TURNING IT TO YOU, ALEX.
THANKS FOR BEING OUR LEADER
TODAY.
>>THANK YOU, REBEKAH.
>>REBEKAH, I'M ACTUALLY AN
INVESTIGATOR ON TWO OF THESE.
PUTTING ME IN A WAITING ROOM OR
SOMETHING?
>>NO. THANKS FOR DISCLOSING
THAT. I THINK WITH HAVING
DISCLOSURE POTENTIAL CONFLICT I
THINK AS LONG AS THE GROUP IS
AWARE OF THAT YOU ARE ALLOWED TO
PARTICIPATE IN THE DISCUSSION.
IT IS ALL OPEN SO EVERYONE
HEARS.
>>OKAY. JUST FOR THE GROUP,
I'M AN INVESTIGATOR ON THE FIRST
TWO BEING OPPOSED JUST SO
EVERYBODY KNOWS.
>>GREAT. I DON'T KNOW IF I'M
ONE AND THIS IS ONE WE HAVE
WORKED WITH KRISTEN ON EMS AND
WE HAVEN'T OFFICIALLY SUBMITTED
IT YET AND IF IT IS I AM WORKING
WITH EMS PROPOSAL WITH NIDA AND
ALSO WITH PRIOR MAYBE ONES THAT
WILL BE DONE BY 2023 IF WE
DISCUSS THAT.
>>THANK YOU FOR YOUR
TRANSPARENCY.
>>I WOULDN'T HAVE SAID IT
BETTER MYSELF, REBEKAH. THANKS
FOR BEING HERE AND LISTENING AND
WALKING YOU THROUGH FOUR
CONCEPTS TODAY.
AUTHORS OF THE CONCEPTS ARE ALSO
IN ATTENDANCE HERE TODAY.
THEY ARE USUAL CT EXPERT AND
COLEADER IS NOT AVAILABLE TODAY.
I HAVE A PINCH HITTING AND I'M
GRATEFUL TO EXTRA EXPERTISE WE
HAVE HERE AVAILABLE FOR THIS
MEETING.
ON THIS SLIDE ARE CTM STUDIES WE
HAVE THROUGH HEAL AND TOO MANY
TO RUN DOWN AND TELLING YOU ONES
WITH GREEN DOTS ARE ACTIVELY
COLLECTING DATA NOW. ORANGE
DOTS REPRESENT PREIMPLEMENTATION
AND BLACK DOTS MEAN DATA
COLLECTION IS COMPLETE AND THAT
DATA ANALYSIS IS CURRENTLY
UNDERWAY. NEXT SLIDE, PLEASE.
I WILL WALK YOU THROUGH WAY THAT
TEAM RANKED THROUGH CONCEPT AND
SCORES REPRESENT CO-CHAIR
PRIORITY RANKINGS AND ONE BEING
HIGHEST TWO MEDIUM AND 3 LOW
WITH LOWEST SCORE REPRESENTING
HIGHER PRIORITY AND MANY A**
SPEBLTHS OF STUDIES WILL BE
DISCUSSED AND WORKED OUT DURING
PROTOCOL DEVELOPMENT PROCESS AND
ONCE DEVELOPED IT WILL HAVE
INDEPENDENT REVIEW BY PROTOCOL
REVIEW BOARD AND WILL INCLUDE
DISCUSSIONS FOR GROUP MEMBERS
AFTER EACH CONCEPT AND WE WILL
HAVE TIME TO TAKE A SIMILAR
APPROACH THAT TISHA AND WENDY
DID AND IF NOT I WILL BE HAPPY
TO WALK THROUGH THEM AND FULL
SLIDE DECK AND CONCEPTS ARE HERE
TO HELP ME FIELD QUESTIONS TOO.
NEXT SLIDE, PLEASE.
TO START WITH IMPLEMENTATION TO
FAS ILL ENGAGEMENT IN DETOX
SETTINGS. HEAL INITIATIVE IS
IMPROVING MOUD IN VARIETY OF
SETTINGS SUCH AS PRIMARY CARE
AND ED AND JUSTICE SYSTEM AND
MAIN STAYS ODEM CONTRIB TUM --
LINKAGE AND ASSOCIATION TO
TREATMENT AND BARELY OCCURS LESS
THAN 1 OUT OF 5OUD PATIENTS
RECEIVE -- THIS IS TO CLOSE GAP
INCREASING INFORMATION AND LINK
RAGE TO TREATMENT IN DETOX
SETTINGS AND PROPOSED CONCEPT
BUILDS ON EXPERIENCE OF
MATERIALS IN SCTNWDF TRIAL AND
ADAPTING SHARED DECISION MAKING
TOOLKIT AND EMPLOY STANDARD
IMPLEMENTATION STRATEGY SUCH AS
LOCAL SITE NEEDS ASSESSMENTS TO
INCREASE LINKAGE TO DETOX
SETTINGS AND STUDIES CONSISTING
OF TWO PHASES FIRST PLANNING AND
INTERVENTION REFINEMENT PHASE
FOLLOWED BY SECOND MULTI-SITE
TRIAL AND IF SHOWN TO BE
EFFECTIVE INTERVENTION WOULD
EXIST AS ATTC PRODUCT WITH
FUTURE DISSEMINATION AND
POTENTIAL ACROSS DETOX SETTINGS
BY NATIONAL ATTC NETWORK.
NEXT SLIDE, PLEASE.
I HAVE A FEW POTENTIAL
DISCUSSION QUESTIONS UP HERE KEY
THEMES INCLUDE FACTORS
FACILITATING OR SLOWING
IMPLEMENTATION AND FOLLOWING UP
RETENTION AND COMMON THEME I
WILL WEAVE THROUGHOUT DISCUSSION
QUESTIONS HERE TODAY IS
STAKEHOLDER ENGAGEMENT AND DATA
SHARING AND REBEKAH IF WE HAVE
TIME HERE WE CAN JUMP INTO
DISCUSSION NOW RATHER THAN
WAITING FOR THE END.
>>YOU KNOW, I WONDER, ALEX,
WHAT YOUR PREFERENCE IS. I
THINK THAT IN SOME WAYS THESE
ARE PRETTY SIMILAR IN THAT THERE
IS SOME -- THERE ARE MORE
SIMILARITIES AMONG CONCEPTS THAN
IN THOSE PRESENTED BY THE LAST
TEAM.
IF IT WOULD BE EASIER FOR YOU, I
THINK YOU CAN KIND OF GO THROUGH
AND DISCUSS AS A WHOLE. I WOULD
JUST POINT OUT THAT WE HAD SOME
KIND OF LAST-MINUTE ATTENDANCE
ISSUES.
OUR ASSIGNED DISCUSSANTS MIGHT
NOT BE ON THE CALL AND IS A FREE
FOR ALL GETTING TO DISCUSSION
AND SINCE THEY ARE PRETTY
SIMILAR AND ARE ALL TRIALS AND
EVERYTHING I THINK IT IS FINE TO
JUST CONTINUE. WE WILL ISSUE BY
ISSUE WHEN WE GET TO THE
DISCUSSION SECTION.
>>SURE. I WILL MENTION THEMES
OR CORE THEMES AND QUESTIONS AND
WHEN I PUT SLIDES UP. LIKE YOU
SAID, WE CAN WAIT UNTIL THE END
TO REALLY DIVE INTO THE
DISCUSSION. I WOULD BE HAPPY TO
REVISIT ANY SLIDES THAT PEOPLE
LIKE IF THEY WANT TO JUMP BACK
AND FORTH AND LET'S GO TO THE
NEXT SLIDE, PLEASE.
ONSITE -- THIS PROJECT SEEKS TO
OVERCOME STRUCTURAL BARRIERS OUD
TREATMENT AND FRAGMENTATION
STIGMA EXPERIENCING IN MEDICAL
-- USING DRUGS ET CETERA
INTEGRATING PROGRAMS OR SSPS AND
PEOPLE USE OPIOIDS REPORTING
SSPS IN LOW STIGMA ENVIRONMENTS
AND WILLING TO RECEIVE SERVICES
THERE THAN IN OTHER SETTINGS AND
MODEL CONCEPT BUILDS ON SSPS AND
HIV PREVENTION TREATMENT
STRATEGIES BECAUSE RESEARCH
SHOWS SERVICES PROVIEDING SSPS
CAN IMPROVE HEALTH OF PEOPLE
USING DRUGS AND THAT HAVE PUBLIC
HEALTH BENEFITS AND COALATE
LOCATED IN FORMS OF
COMPREHENSIVE SERVICES IMPORTANT
TO ASSESS SSP AND ADDRESS HIV
AND CONCEPT TO TRANSLATE THOSE
INTO OUD AND OBSERVATIONAL
STUDIES OFFER PRELIMINARY
INFORMATION FOR THAT AND STRONG
MEDIAN DAYS COVERED BY NORBU
PREN EF RIN -- DECREASES IN
POSITIVE URINE ANALYSIS FOR
OTHER OPIOIDS AND THIS
EFFECTIVENESS TRIAL ONSITE LOW
THRESHOLD TREATMENT FOR SSPS
CONDUCTED IN THE CTN.
PREPARATION PHASE ORE YEAR 1
INVESTIGATORS WILL IDENTIFY
PARTNER SSPS AND ACCESS
ACCEPTABILITY AND FEASIBILITY
AND READINESS FOR ONSIGN
TREATMENT. NTVENTION PHASE
YEARS 2 TO 4 USE SSP RANDOMIZED
STEP WENL DESIGN TO STAGGER
TREATMENT IMPLEMENTATION ACROSS
SSPS WITH READINESS MILESTONES.
NEXT SLIDE, PLEASE.
>>LIKE I SAID THERE ARE COMMON
THEMES ACROSS QUESTIONS AND
IMPORTANT TOPICS AND
CONVERSATIONS AROUND THIS
CONCEPT INCLUDE POPULATIONS AND
CONTEXT. UTILITY ACROSS THEM.
AGAIN, STAKEHOLDER ENGAGEMENT
AND FACILITATION OF ENGAGEMENT
AMONG UNHOUSED PEOPLE
ESPECIALLY. NEXT SLIDE, PLEASE.
THIS STUDY IS FOR MDD AND NORBUP
NEF RIN AND THIS CONCEPT WOULD
EVALUATE EFFICACY OF HIGH DOSE
BU PROEP REON 450 MILLIGRAMS PER
DAY AMONG PLACEBO AND PATIENTS
WITH MAJOR DEPRESSIVE DISORDER
FOR DIAGNOSTIC CRITERIA
MAINTAINED ON BU PREN OR FRIN
AND RETENTION AS PRIMARY OUTCOME
AND DEPRESSIVE DISORDERS ARE
COMMON DIAGNOSIS FOR ODN AND --
WORSE PROGNOSIS AND TREATMENT
AMONG TREATMENT OUTCOMES
POINTING TOWARDS NEED FOR
EFFECTIVE TREATMENT OPTIONS AND
RESEARCH THAT CAP -- BU PROEP
REON ANTIDEPRESSANT EFFECTS TO
HELP CURB STS FOR YA AND
WITHDRAWAL AND INDUCED CRAVING
AND PREVIOUS WORK OF
ACCOMMODATION OF ORAL APPROACH
REON IS SAFE AND EFFECTIVE FOR
MODERATE TO -- BETTER EFFECTS ON
MDD THAN PLACEBO AND THERE IS
SEQUENTIAL COMPARISON DESIGN
POTENTIAL ISSUES TO HIGH DESIGN
PLACEBO RESPONSE RATE AND
PARTICIPANTS IN TRIAL WOULD
RECEIVE BU PROEP REON AND
PARTICIPANTS RANDOMIZE TODAY
RECEIVE PLACEBO DURING 6 WEEK
STAGE 1 AND PLACEBO
NONRESPONDERS ARE RERANDOMIZED
IN PLACEBO DURING 6 WEEKS STAGE
2 AND ONE THING WE WONDER ABOUT
IS IF ELIGIBILITY CRITERIA THAT
ARE THREE CO-OCCURRING
CONDITIONS TOO STRINGENT TO
SUPPORT RECRUITMENT TARGETS AND
CO-OCCURRING MENTAL HEALTH
ISSUES ARE EXCLUDED SUCH AS
ANXIETY AND GOOD SEGUE TO IDEAS
OF DISCUSSION OF CONCEPTS SO
NEXT SLIDE, PLEASE.
A FEW THINGS WE THOUGHT WOULD BE
WORTHWHILE TO DISCUSS ARE IDEAS
FOR MEASUREMENT PLANS AND
CORRECT STAKEHOLDERS TO ENGAGE
IN THIS RESEARCH.
NEXT SLIDE, PLEASE.
EMS INITIATED -- COHORT STUDY OF
PATIENTS EXPERIENCING OVERDOSE
RECEIVE EMS CARE BU PREN OR
FREEN AMBULANCE OR -- EXPOSURE
TO THE AMBULANCE WAS ASSOCIATED
WITH DECREASE IN WITHDRAWAL
SYMPTOMS DPRAETER ODDS OF
ENGAGING IN OUD TREATMENT WITHIN
30 DAYS OF EMS ENCOUNTER AND NO
DIFFERENCE IN OUD -- 36 PATIENTS
IN CALIFORNIA RECEIVING BU PREN
OR FRIN IN ENCOUNT ER -- PATIENS
HAD 50% RATE OF RETENTION
TREATMENT IN 7 DAYS AND 36% WERE
IN TREATMENT AT 30 DAYS AND WE
SEE PROGRAMS AS CALIFORNIA STATE
MRNL MEDICAL SERVICE COMMISSION
ADAPTING REGULATION TO
PARAMEDICS SCOPE OF PRACTICE
ALLOWING THEM TO ASSESS AND
ADMINISTER IT WITH FIRST
RESPONDERS AND PATIENTS WITH OUD
AND CRITICAL RESEARCH ON
INNOVATIVE AND PROMISING
APPROACH AND CONKRECHTS ENTAIL
MULTI-SITE FOR 3 TO 4 SITE STUDY
EVALUATING EFFICACY AND
EFFECTIVENESS OF [INDISCERNIBLE]
FOR PATIENTS WITH OUD AND
WITHDRAWAL FOLLOWING OPIOID
REVERSAL THROUGH CTA AND PHASED
DURING STAGE OF SCIENCE AND
EFFICIENCY AND URNL OF RESEARCH
APPROACH TO STEM RATE OF
[STANDING OVATION] DOSES WE ARE
SEEING IN PUBLIC HEALTH CRISIS.
OUD PRESENTING WITH OVERDOSE
WOULD BE DEVELOPED INTO 5 AND
PHASE 2, THEY WOULD CONDUCT
EFFICACY OR EFFECTIVENESS TRIAL
COMPARING PATIENTS WITH OUD AND
WITHDRAWAL FOLLOWING OPIOID
OVERDOSE REVERSAL RECEIVING --
PATIENTS RECEIVING USUAL MEDICAL
CARE AND WITH PRIMARY OUTCOME OF
ENGAGEMENT IN MOUD TREATMENT IN
30 DAYS AND THIS MODEL WOULD
BUILD OUT SUCCESS OF HIPS AND
PREVENTION TREATMENT AND I'M
SORRY I PUT WRONG ONE UP FOR THE
SLIDES YOU CAN DISREGARD THAT.
NEXT SLIDE, PLEASE.
A FEW MORE DISCUSSION QUESTIONS
THAT PROBABLY LOOK FAMILIAR. IF
YOU HAVE A FEW THINGS TO TALK
ABOUT WITH THIS WOULD BE
APPROPRIATE FOLLOW UP HERE TO
MEASURE RETENTION AND FRACKING
ACROSS DIFFERENT DISTRICTS AND
DUE TO EMS POLICIES AND
IMPLEMENTATION BARRIERS.
TRAINING AND STAKEHOLDER
ENGAGEMENT AGAIN.
GOING TO NEXT SLIDE IS
CONCLUSION OF PREPARED COMMENTS
HAPPY TO WELCOME IN CONCEPT
AUNLORS AND WG COMMENTERS IT
INITIATE THE DISCUSSION.
>>THANK YOU SO MUCH. ALEX,
THAT WAS INCREDIBLE.
BEFORE WE GET STARTED IS NORA
ON? I INVITE YOU IF THERE IS
ANYTHING YOU WOULD LIKE TO ADD
FROM NIDA PERSPECTIVE IF YOU ARE
THERE.
>>YES. NO. I AM THERE.
>>YEAH.
>>I THINK THERE ARE SEVERAL
ASPECTS.
THREE PROJECTS IN A WAY ARE
BASICALLY USING DIFFERENT
STRATEGIES TO EXPAND NUMBER OF
PEOPLE THAT CAN BE INITIATED ON
BOOU NOR EPINEPHRINE W-
DETOXIFICATION PROGRAM OR
WHETHER MRNL MEDICAL SERVICES ON
EXCHANGED SERVICES ARE OVER --
THAT IS UNDERSTANDING IMPACT
THAT EACH ONE OF THEM HAS AS IT
RELATES NUMBER OF PEOPLE THAT
CAN HELP THAT IS IMPORTANT THAT
CAN DETERMINE WHETHER THREE
INITIATIVES SHOULD BE IN
PARALLEL OR SHOULD WE
PRIORITIZE?
IT IS AN IMPORTANT QUESTION AND
REALIZE OF COURSE AS WE MAKE
DECISIONS THAT PATIENT
POPULATION IS GOING TO BE VERY,
VERY DIFFERENT AND QUESTION I
WAS EMERGING IN MY BRAIN I
WANTED TO ASK GAIL. SHE IS ONE
THAT WORKS ON THIS POPULATION IS
IF YOU ACTIVATE MRNL MEDICAL
SERVICES AND ARE INITIATING
SOMEONE ON NOREPINEPHRINE YOU
ARE VERY LIKELY BRINGING
DESPERATION INTO MRNL
DEPARTMENT. WHAT IS THE
ADVANTAGE OVERALL TO INITIATE IN
MRNL OR SAY FOR EXAMPLE IN
AMBULANCE OPPOSED TO EMERGENCY
DEPARTMENT OR IS IT BECAUSE MRNL
MEDICAL SERVICES DON'T
NECESSARILY BRING A SIGNIFICANT
PORTION OF PATIENTS INTO THE
MRNL DEPARTMENTS?
THAT IS SOMETHING I WOULD LIKE
TO HEAR FROM THOSE OUT THERE IN
THE TRENCHES AND I'M PUTTING YOU
ON THE SPOT.
>>SURE. EMS IS RUN DIFFERENTLY
IN MY STATE BY COUNTY AND
CERTAINLY STATE BY STATE AND
CITY BY CITY.
MANY PLACES THERE IS NO
REQUIREMENT TO BRING TO MRNL
STATEMENT AND IN MY CASE THERE
IS A REQUIREMENT CALLING US AND
WHY THEY DON'T WANT TO COME AND
MANY STATES PATIENTS SAY I DON'T
WANT TO COME. I'M FINE. I'M
LEAVING. ADVANTAGE OF THIS IS
YOU CAN CAPTURE PEOPLE WHO MAYBE
WE COULD INITIATE AND IN STUDIES
THERE WERE TWO AND THEY WERE
DONE VERY DIFFERENTLY AND WHEN
THEY STARTED OUT IN CALIFORNIA
BRIDGE THERE WERE PEOPLE WITH
OVERDOSE WHO THOUGHT THEY COULD
GIVE RIGHT AWAY AND THEY WERE
CALLING WITHDRAWAL AND CALLING
CMS AND IN THOSE CASES INITIATED
IT THEN AND PEOPLE WERE LIKELY
TO FOLLOW UP AND SAY OKAY WE
WILL START YOU HERE AND WILL YOU
GO HERE TOMORROW.
THAT SEEMS TO HAVE SIGNAL THAT
WORKS AND IS LATTER YOU ARE
SAYING IF COMING TO ED WOULDN'T
BE A PROBLEM AND MANY PEOPLE ARE
REVOLVING DOORS WITH EMS.
WE TRIED TOO SENDING OUT
RECOVERY PEOPLE TO SEE AFTER
THEY HAD BEEN NEXT D LATER THAT
DOESN'T SEEM TO WORK. WE TRIED
THAT.
THIS IS AN OPPORTUNITY.
>>I GUESS WHAT YOU ARE SAYING
GAIL IF I READ YOU CORRECTLY
THERE MIGHT BE STATES YOU ARE
NOT OBLIGED BUT IN GENERAL
SEEING ACROSS THE STATE
REGARDLESS IT WOULD BE VALUABLE
FOR THOSE CALLING MRNL SYSTEM
FOR THOSE THAT ARE WITHDRAWAL
AND WANT SOMETHING TO HELP THEM
OVERCOME WITHDRAWAL.
>>WHY HE.
>>NOREPINEPHRINE AND THAT WILL
BE IMPORTANT BASICALLY THAT WE
PERHAPS TARGET THAT POPULATION
AND SECOND POINT I WANTED TO
MAKE ARE THESE ARE THREE STUDIES
THAT HAVE SIMILAR GOALS TO
EXPAND ACCESSIBLE NOREPINEPHRINE
AND SEKTD ONE IS DIFFERENT AND
THAT IS USE OF [INDISCERNIBLE]
AN ANTIDEPRESSANT THAT HAS
INTERESTINGLY STRONG
[INDISCERNIBLE] URNLIC EFFECTS
AND RILT OF TENDS TO LEAD TO
BETTER OUTCOMES WITH PATIENTS
WITH SUBSTANCE USE DISORDERS IN
GENERAL.
>>ABOUT THIS PARTICULAR
PROPOSAL COMING BACK TO NOTION
ABOUT ISSUES OF COMORBIDITIES IS
DEPRESSION IS EXTRAORDINARILY
PREVALENT WITH PEOPLE WITH
OPIOID DISORDER IF YOU LOOK AT
ELECTRONIC RECORDS AND USE THEM
TO MONITOR OUTCOMES OF LARGE
PATIENT GROUPS WHAT ONE STUDY
HAS SHOWN IS INDIVIDUALS WITH
OPIOID USE DISORDER THAT WERE
GIVEN [INDISCERNIBLE] ALL THOSE
SUBJECTED THAT WERE GIVEN
ANTIDEPRESSANTS WHEN INITIATED
ON NOREPINEPHRINE OR HAD
ANTIDEPRESSANTS AND SUSTAINED
THROUGHOUT HAVE MUCH LOWER RISK
OF OVERDOSED DA DAENLS. IT IS
THE EFFECT ANTIDEPRESSANTS
WHETHER YOU DO OR DON'T HAVE
DIAGNOSIS OF DEPRESSION AND MAY
BE BENEFICIAL. FOR ONCE, IT
MIGHT BE VALUABLE TO OVERCOME
SOME LONG-LASTING WITHDRAWAL
SYMPTOMS LEADING PASHENS TO
RELAPSE WHEN THEY ARE IN
TREATMENT AND I'M EXTREMELY
SUPPORTIVE OF THIS TRIAL.
IT BEGS A QUESTION THAT WE NEED
TO ADDRESS PATIENTS WITH
ANTIDEPRESSANTS ARE DOING BETTER
AND WE HAVE OPPORTUNITY TO
UNDERSTAND HOW TO ADMINISTER IT
AND WHAT EFFECT SIZES ARE AND
REPLICATING IN RANDOMIZED
CLINICAL TRIAL FINDINGS FROM
ELECTRONIC HEALTH RECORDS.
TURNING IT BACK TO YOU REBEKAH
AND DISCUSSANTS BECAUSE THESE
ARE POINTS I WANTED TO SAY.
>>I MAY GO BACK TO ALEX WHO HAD
DISCUSSIONS OR QUESTIONS AROUND
STAKEHOLDERS AND WHICH
STAKEHOLDER WHO IS KIND OF
EXPANDING BEYOND OUR TRADITIONAL
HEALTH CARE SYSTEMS IN CERTAIN
WAYS.
WE WANT TO APPROACH THAT WITH
LOTS OF THOUGHTFULNESS.
I'M INTERESTED IN ALEX'S
THOUGHTS ON THAT AS WELL AND SEE
NED'S HAND IS RAISED.
GO RIGHT AHEAD, NED.
>>THANK YOU. DISCLOSURE I'M IN
CTM AND DIDN'T HAVE ANYTHING TO
DO WITH THIS CONCEPT. I AGREE
WITH YOUR POINT, NORA. IF I
UNDERSTAND YOU CORRECTLY I THINK
WHAT YOU ARE SUGGESTING IS IT
MIGHT BE HELPFUL TO PATIENTS
WITH COMBINATION OF OPIOID USE
DISORDER AND METHAMPHETAMINE USE
DISORDER WHETHER OR NOT THERE IS
REALLY DEPRESSION THERE YOU CAN
DIAGNOSE AND AGREE WITH YOU AND
WHAT I RECOMMEND FOR THIS
CONCEPT IS TO NOT MAKE
DEPRESSION AN ELIGIBILITY
CRITERION. IT WILL MAKE IT
HARDER TO RECRUIT AND HAVE TO
FIGURE OUT WHERE TO MEASURE
DEPRESSION AND WHERE TO DRAW THE
LINE. LOTS OF DEPRESSION IS IN
THESE POPULATIONS AND MOST IS
SUBSTANCE ABUSE AND GETS BETTER
IF YOU CAN EFFECTIVELY TREAT
SUBSTANCE USE DISORDER.
I WOULD SIMPLIFY THIS DOING A
TRIAL OF IT VERSUS PLACEBO IN
PATIENTS WITH SUBSTANCE USE
DISORDERS AND BU PROPREON
ADDRESSING THIS QUESTION DOES IT
HELP PEOPLE WITH OPIOID USE
DISORDER WITH CO-OCCURRING
METHAMPHETAMINE USE DISORDER AND
DEPRESSION AND LOOKING AT
SECONDARY ANALYSIS WHETHER
DEPRESSION IS A MODERATOR. I
WOULDN'T SELECT PEOPLE FOR
DEPRESSION. IT WILL MAKE IT
HARDER TO RECRUIT AND REDUCE
GENERALIZABILITY.
I WILL BET IT HELPS AS MUCH IN
PEOPLE WHO DON'T HAVE DIAGNOSED
DEPRESSION AND THEY ARE
SUFFERING FROM NEGATIVE EFFECT
AND SO FORTH PART OF.
>>VICE CHAIR MIKE ETHERIDGE:
AMPHETAMINE WITHDRAWAL AND IS MY
MAIN. I THINK IT IS GREAT TO
SEE THIS AND HAPPY TO SEE FOCUS
ON DEPRESSION AND WOULD EVALUATE
IT AND LOOK AT IT AS A MODERATOR
BUT NOT SELECT FOR IT.
>>NED, I COMPLETELY AGREE WITH
YOU AND BRING IT UP THAT IT AND
ELECTRONIC HEALTH RECORDS NOT
JUST ANTIDEPRESSIENTS IN GENERAL
BUT DOING LONG LASTING ONES AS
WELL. THESE ARE FOR PATIENTS
MAINTAINING NORBU PREN OR FRIN
WE KNOW IT WORKS WELL AND CAN WE
IMPROVE RETENTION IN TREEM
GIVING THEM BRO PROEP REON AND
IMPROVE LIKELIHOOD THEY ACHIEVE
RECOVERY AND TO BETTER OUTCOMES?
IN THIS POINT AND MY PERSPECTIVE
LET'S LOOK AGAIN IN TERMS OF
FLEXIBILITY THAT ARE NOT
NECESSARILY LIMITED TO PATIENTS
WITH OUD PLUS METHAMPHETAMINE
USE DISORDER THAT IN AND OF
ITSELF INCLUDING PATIENTS WITH
AN OPIOID USE DISORDERS THAT MAY
BE CO-USING OTHER SUBSTANCES OR
NOT WHETHER USE OF -- ALONGSIDE
A PLACEBO WHETHER IMPROVE
OUTCOMES IS WAY I VIEW IT AND
WILL ALLOW US TO HAVE GREATER
CLARITY AND ABSOLUTELY YOU ARE
RIGHT ON TARGET AND DON'T THINK
WE SHOULD LIMIT IT TO PATIENTS
WITH DIAGNOSIS OF DEPRESSION.
>>YOU ARE RIGHT. THERE IS A
NUMBER OF CLINICAL TRIALS IN
LITERATURE OF ANTIDEPRESSANTS
TREATING DEPRESSED SUBSTANCE USE
DISORDERS OF TYPES AND
DEPRESSANTS TEND TO DO BETTER
AND IN OLD DAYS TRICYCLICS AND
[STANDING OVATION] ALL
ANTIDEPRESSANTS SEEM TO WORK
BETTER THAN SERO-10 URNLIC ONES
SHOWN IN NICOTINE DEPENDENCE FOR
EXAMPLE AND I LIKE THE IDEA OF
GIVING BU PROEP REON TO PATI
PATIENTS.
LET METHAMPHETAMINE BE SOMETHING
TO TEST AND MEASURE AS A
MODERATOR.
>>OR COCAINE.
>>YEAH.
>>HI. THANK YOU VERY MUCH FOR
COMMENTS ON THIS CONCEPT. I
AGREE THEY ARE VALID POINTS THAT
I WILL MODIFY CONCEPTS
ACCORDI
ACCORDINGLY.
>>ANYWAY, THOSE WERE POINTS I
WANTED TO SAY. I ACTUALLY GIVE
CUEDOS TO WHAT OTHERS WANT TO
BRING UP FOR THE DISCUSSION.
>>YES. THANK YOU, NORA.
AND IN TERMS OF BOTH THE
CO-OCCURRING MENTAL HEALTH AND
SUBSTANCE USE DISORDER CONCEPTS
AND IN TERMS OF CONCEPTS THAT
INTRODUCE MEDICATION FOR
TREATMENT OF OPIOID USE DISORDER
INTO DIFFERENT SETTINGS OR
INSTANCES THERE WERE SOME
THOUGHTFUL DISCUSSION QUESTIONS
PUT FORWARD.
I WOULD OPEN IT UP TO THE GROUP
AND ASK FOR YOUR INPUT OR
ADDITIONAL THOUGHTS.
CHRISTIAN I SEE YOUR HAND IS
RAISED. PLEASE GO RIGHT AHEAD.
>>COMMENT ON RAPID INDUCTION OF
NORBU PREN OR FREN WE HAVE TO
CONSIDER SIGNIFICANT EVIDENCE
HOW YOU DO THAT ESPECIALLY IN
FENTANYL EXPOSED PATIENTS THAT
[INDISCERNIBLE].
SO, THERE ARE DIFFERENT SCHOOLS
OF THOUGHTS THAT I THINK WE HAVE
TO CONTINUE TO GATHER DATA TO
REALLY COME UP WITH BEST
PRACTICES ON [INDISCERNIBLE] IN
A RAPIDLY EVOLVING LANDSCAPE NOW
WITH SYNTHETIC OPIOIDS AND THINK
WE HAVE TO REALLY TAKE IT INTO
CONSIDERATION.
>>THANK YOU.
NAT, YOUR HAND IS RAISED.
>>SO, I MEAN, GAIL, I WOULD BE
INTERESTED IN YOUR THOUGHTS ON
THIS AND SENSES NEXT MS SETTING
THAT EVERY MINUTE YOU DELAY
GETTING PATIENTS ON BOOU PREN OR
FREN IS ANOTHER MINUTE THEY WILL
DROP OUT OF TREATMENT AND WALK
OUT AND GET INTO WORSE
WITHDRAWAL FOR WHATEVER REASON.
SO, THIS SEEMS VERY ATTRACTIVE
TO ME THE IDEA OF GETTING -- IF
YOU CAN GET BU PREN EF RIN IN
ORDER RIGHT AWAY AND I WONDER
WHAT YOU THINK ABOUT IT.
I AGREE. FASTER WE CAN GET IT
IN AFTER REVERSAL THE BETTER.
AND THIS IS A LITTLE BIT OF A --
I'M TELLING YOU SOMETHING A
LITTLE EARLY AND HOPING WE HAVE
A PAPER THAT WILL BE PUBLISHED
VERY SHORTLY BACK AND FORTH A
ZILLION TIMES TO JAMA NETWORK
PLACES AND IN OUR CURRENT STUDY
OF BU PREN OR FRIN THERE IS
STANDARD DOSING VERSUS CAM28
THAT IS A 7-DAY INJECTABLE THAT
WE HAVE ENROLLED IN THIS MOMENT
MORE THAN 1350 PATIENTS
NATIONWIDE AND 28 SITES OVERALL
THAT HAVE ENROLLED PATIENTS. WE
ONLY HAVE 9 EPISODES OF
[INDISCERNIBLE].
THOSE ARE, YOU KNOW, CONSISTENT
SURVEILLANCE ADJUDICATED ABOUT I
DR. WAL SHALL AND LOCK WALL IN
KENTUCKY WITH ANY SITUATION
BROUGHT UP THAT WANTED TO REVIEW
AND WE DON'T HAVE CONFLICTS
BETWEEN TREATING TEAM AND
ADJUDICATORS AND WE ONLY HAVE 9.
WHILE IT CAN HAPPEN AND IF YOU
LOOK HISTORICALLY WITH PEOPLE
WITH PRECIPITATED WITHDRAWAL AND
IN LITERATURE IT IS MUCH HIGHER
THAN THAT. I DON'T KNOW. IT IS
PART OF A TRIAL. CAN YOU ALWAYS
HAVE THINGS PART OF A TRIAL THAT
ARE DIFFERENT FOR EVERYONE.
ALMOST 76% OF THE ENTIRE SAMPLE
USES FENTANYL THAT IS DRAWN FROM
MANY AREAS THAT USE FENTANYL AND
ALL NINE PATIENTS HAVE FENTANYL
WITH OTHER THINGS, ET CETERA.
THERE WAS NO PHENOTYPE THAT I
COULD TELL YOU OF ANY ONE. SOME
USED A LOT AND SOME DIDN'T.
SOME WERE A DAY OR SO MORE OUT
OF AND SOME WERE 6 HOURS AND
THERE WAS NO RHYME AND REASON IN
THE 9 PATIENTS AND WE TALK ABOUT
IT A LOT IN CASE SERIES AND THAT
IS ABOUT IT. I THINK WE ARE
USING A LOT MORE BU PREN OR FRIN
THAN WE DID IN THE PAST AND HAVE
A BIGGER CRISIS USING MORE
MEDICATIONS AND ARE SEEING
PRECIPITANT WHICH WE KNOW WE
WILL SEE AND WE WERE IN AN ED
AND WE TREAT IT VERY FAST.
IF SOMEBODY HAS A ROCKY ROAD
THEY START TO FEEL DIFFERENTLY
WE GIVE THEM MORE. WE HAVE NO
ISSUES WITH THAT REALLY. WE
KEEP GIVING THEM MORE AND MORE
BUPE AND THEY DO WELL AND LEAVE
AND MAYBE THERE IS WHAT THIS
MEDICATIONS THAT WE HAVE AND
FEEL COMFORTABLE GIVING EDS THAT
ARE NOT IN ANY AMBLATTORY
SETTINGS AND PRECIPITATED
WITHDRAWAL I'M NOT WORRIED ABOUT
IT HONEST WILL I GETTING IT IN
QUICKLY AND IF PERSON IS IN
WITHDRAWAL OF AT LEAST 8 WE CAN
GIVE THIS AGAIN AND IF THERE
WERE ANY ISSUES WE CAN STILL
CONTINUE TO TREAT THEM AND THEY
CAN BE TRANSPORTED TO ED AND WE
HAVE AN OPEN POLICY IN THOSE OF
US DOING THIS THAT THEY CAN COME
BACK AND PROBABLY IS NOT TRUE
EVERYWHERE IN THE WORLD BUT
ANYONE DOING STUDIES WOULD BE
ABLE TO COME TO ED AT ANY
MOMENT.
>>MY QUESTION TO YOU, GAIL. I
THINK OBVIOUSLY YOU HAVE BROUGHT
THIS IN OUR LAST MEETING THAT
THERE IS THE NOTION YOU ARE
BEING ABLE TO PUBLISH IN
EMERGENCY DEPARTMENT THAT YOU
CAN INITIATE HIGH DOSES OF
NOREPINEPHRINE WITH LITTLE
EVIDENCE OF PATIENTS GOING INTO
WITHDRAWAL AND ASK YOU QUESTION
BECAUSE IT IS FROM
PHARMACOLOGICAL PERSPECTIVE THAT
IS A VERY RELEVANT ONE AND I
REALIZE YOU HAVE 1,350 PATIENTS
YOU RECRUITED AND FROM THESE
PATIENTS WHAT PERCENTAGE OF THEM
HAD BEEN OR RECEIVED NAL OX YOEN
PRIOR TO ASSOCIATION OF NORBU
PREN EF FRIN AND INTERVENTION
FROM PHARMACOLOGY THAT REVERSES
PHYSICAL DEPENDENCE AND TO
EXTENT YOU CAN GIVE NAL OX YOEN
YOU HAVE REVERTED THE SYSTEM AND
ARE MUCH LESS LIKELY TO TRIGGER
WITHDRAWAL. DO YOU KNOW NUMBERS
BECAUSE --
>>I DON'T KNOW THAT NUMBER. IT
IS NOT A HUGE AMOUNT THOUGH.
>>MAJORITY OF PARTICIPANTS
ENDED UP IN MRNL DEPARTMENT.
THEY DID NOT REQUIRE REVERSAL
FOR THEIR OVERDOSES AND WERE
PATIENTS THERE FOR OTHER CAUSES.
>>YES.
>>WHAT ARE CHARACTERISTICS?
>>THEY ARE THERE FOR EITHER
SEEKING TREATMENT OR THEY ARE
THERE FOR SOME OTHER ASPECTS
THAT HAVE NOTHING TO DO WITH
OPIATE ADDICTION OR THEY COULD
HAVE OVERDOSED.
THERE IS A PROPORTION BUT IT IS
NOT A HUGE PROPORTION THAT CAME
IN AFTER AN OVERDOSE AND SOME
PRECIPITATED OWN WITHDRAWAL IN
THE COMMUNITY TAKING BU PREN OR
FRIN WITHOUT BEING IN WITHDRAWAL
AND ARE NOT HUGE AMOUNTS OF
THOSE THEY ARE ALL DIFFERENT
REALLY.
>>IT COULD BE VERY IMPORTANT TO
LOOK AT DETAILS.
>>YES.
>>ACTUALLY, ONE ISSUE I
BASICALLY IN SPEAKING WITH
PATIENTS THAT IS A MAJOR CONCERN
IS WHEN GIVEN BU PREN OR FRIN
THAT TRIGGERS WITHDRAWAL THEY
GET BASICALLY NEGATIVELY
CONDITIONED.
>>RIGHT.
>>TO PUT IT INTO THE FUTURE.
SO, WE DON'T IN ORDER TO BE ABLE
TO MAXIMIZE LIKELIHOOD WE DON'T
HAVE NEGATIVE OUTCOMES
UNDERSTANDING WHO CAN BE AT
RIFSHG AND BRING IT UP ALSO
FASCINATES ME FROM PHARMACOLOGY
PERSPECTIVE YOU KNOW SEVERAL
CLINICIANS PROPOSE BU PREN OR
FRIN TO OVERDOSE AND YOU ARE
PUSHING OUT FENTANYL AND THAT
ELEMENT AND WE KNOW THESE ARE
VERY -- I MEAN, IT MAY BE
ACTUALLY ACT LIKE ANTAGONIST AND
UNDERSTANDING WHAT GOES ON WILL
BE CRUCIAL. IF YOU CAN SHOW
EXACTLY THAT YOU CAN INITIATE
HIGH DOSES IT MAKES IT SO MUCH
MORE PRACTICAL AND SOMETHING WE
CAN GIVE A GUIDELINE CHANGING
PRACTICES THAT EXIST CURRENTLY.
>>WE STILL NEED MORE. WITH
HIGH DOSE INITIATION WE
PUBLISHED WITH ANDREW HERRING A
RETROSPECTIVE REVIEW AND
ALTHOUGH SOME ARE DOING IT,
THERE IS NOT ENOUGH DATA AND ONE
REASON WE NEED TO STUDY IT.
THERE ISN'T. WE HAVE TO GET
PEOPLE COMFORTABLE WITH IT AND
SEE IF IT WORKS AND DOES SUSTAIN
PEOPLE IN TREATMENT.
IN THIS RECENT STUDY I WILL SEE
IF I CAN GO BACK AND SOME DATA I
CAN'T GET NOT AS NIMBLE TO DO
WITH MS AND AS LONG AS IT IS
BASELINE DATA I WILL LOOK AT IT
SEEING HOW MANY FOR YOU AND HOW
MANY PEOPLE HAD A NAL OX YOEN
RESCUE PRIOR TO US INITIATING.
>>WHILE YOU DO THAT QUESTION IS
NEXT MS PROJECT SPECIFICALLY.
>>ALL RIGHT.
>>IS IT BEING ORGANIZED IN SUCH
A WAY THAT IS GIVING US THIS
INFORMATION THAT IS NECESSARY IN
TERMS OF THE DOSES TO INITIATE?
>>OH, YES. YES.
>>WELL, THAT ANSWERS MY
QUESTION. THANK YOU.
>>I THINK WE HAVE HAD A VERY
GREAT DISCUSSION AND I WILL TURN
IT BACK TO YOU, ALEX. WERE
THERE QUESTIONS YOU WANTED TO BE
SURE THAT WE GOT FEEDBACK FROM
MULTI-DISCIPLINARY WORKING GROUP
MEMBERS ON -- WE HAVE LOTS OF
FARM COLDISCUSSIONS.
>>WELL, ONE THING THAT WE HAD
WOVEN THROUGHOUT WAS WHICH
STAKEHOLDERS WE SHOULD BE
ADDRESSING AND LIKE YOU SAID
THEY ARE PROBABLY A BIT
DIFFERENT IN WAY THAT THEY WOULD
BE IMPLEMENTED AND MAYBE SOME
UNCOMMON SETTINGS FOR US.
I WOULD APPRECIATE HEARING
THOUGHTS ON WHO WE SHOULD ENGAGE
IN TO BEST DO THIS RESEARCH.
>>THOUGHTS ON STAKEHOLDERS AND
PLACES THEY WILL STRENGTHEN
SCIENCE AND OVERCOME BARRIERS TO
BE IN PLACE THOUGHTS FROM
MULTI-DISCIPLINARY WORKING
GROUP?
>>I WOULD START SAYING WE HAVE
TO OBVIOUSLY INVOLVE SAMHSA.
ALSO, HRSA. IN TERMS OF HAVING
THEM BE ON BOARD THEY ARE
PROVIDERS OF SUPPORT AND
RESOURCES AND TO EXTENT THEY ARE
ACTUALLY ON BOARD WE WOULD BE
MUCH BETTER TO DEPLOY IT. THOSE
ARE FOR STARTERS.
>>YEAH. THANK YOU. THAT WILL
HELP TOWARDS SUSTAINABILITY AS
WELL. NED?
>>YEAH. SO, I AGREE ABOUT
SAMHSA AND ACTUALLY THE STUDY OF
INITIATE OF BUR PEN EF RIN ON
UNITS IN COLLABORATION WITH
ATTCS FUNDED BY SAMHSA. I WAS
GOING TO SAY ABOUT STAKEHOLDERS
IS, YOU KNOW, PART OF WHAT ALL
IS THAT I THINK ABOUT THAT 80%
WITH OPIOID USE DISORDER ARE NOT
ON MEDICATION. I THINK THOSE
ARE IMPORTANT STAKEHOLDERS AND
THOSE PEOPLE AND PEOPLE IN, YOU
KNOW, THE -- THE STAFF IN HARM
REDUCTION PROGRAMS TAKING CARE
OF THEM. YOU KNOW, WE NEED TO
UNDERSTAND THEIR PERSPECTIVE.
I JUST THINK THAT IS VERY
IMPORTANT AND DON'T KNOW HOW
MANY PEOPLE SAW THE ARTICLE BY
TRACY IN THE NEW YORK TIMES
ABOUT THE BOSTON DOCTOR WHO IS
TAKING CARE OF HOMELESS PEOPLE.
IT --
>>IT WAS AMAZING AND IS A BOOK
EXCERPT.
>>NOW IT IS A BOOK.
>>YEAH.
>>AMAZING. IT GIVES YOU -- YOU
KNOW, THERE IS A REALLY HIGHLY
TRAINED INTERNIST ON WAY TO
FANCY ACADEMIC CAREER THAT
REALLY WENT THROUGH THE LOOKING
GLASS WHEN CAME TIME TO ACTUALLY
FOCUS ON THIS POPULATION OF IN
THAT CASE HOMELESS PEOPLE AND
MANY WITH SUBSTANCE USE DISORDER
AND FEEL WE HAVE TO GO THROUGH
THE LOOKING GLASS ALSO AND TRY
TO UNDERSTAND MORE ABOUT THE
PERSPECTIVE FROM THOSE FOLKS.
>>SO, I THINK THE OTHER
STAKEHOLDER IS HOUSING
AUTHORITIES.
AND HOW TO ENGAGE THEM IN A
MEANINGFUL WAY AND GAIL SAID
THERE IS 50% OF CLIENTS OR
SOMEONE SAID THIS MORNING THAT
ARE HOMELESS.
SO, YEAH. I MEAN, HOUSING IS
HEALTH CARE.
>>YEAH. YEAH. ABSOLUTELY.
>>SO, ADDING TO THAT, DE ACHLT
AND PHARMACIES AND FARMLY
ASSOCIATIONS.
IF YOU RELEASE PEOPLE AND GET
THEM PRESCRIPTIONS OF HIGH DOSE
BU PREN EF RIN WILL YOU HAVE A
HUGE ROAD BLOCK WITH PEOPLE NOT
WANTING TO GIVE THAT AMOUNT AND
PHARMACISTS NO THE WANTING TO DO
THAT AND PERHAPS I WOULD SAY THE
RECOVERY COMMUNITIES AT LARGE
STILL A MASSIVE STIGMA AND
DISCRIMINATION FOR PATIENTS WITH
THESE [INDISCERNIBLE] AND
DISCLOSE THAT TO RECOVERY
COMMUNITIES.
>>GREAT. THANK YOU, ANDREA AND
WALTER HAS ADDED INTO THE CHAT
THAT SOME ADDITIONAL LICHGS FOR
THOSE THAT ARE FOLLOWING.
THE ROUGH SLEEPERS BOOK.
AND COVERAGE WHAT IS HAPPENING
IN BOSTON.
SO, I THINK WE ARE AT A NATURAL
BREAKING POINT. I WOULD LIKE TO
THANK ALL DISCUSSANTS AND ALEX
AND WENDY AND TISHA FOR SHARING
PRESENTATIONS AND CONCEPT LEADS
WHO HELPED TO DEVELOP THEM AND
WERE LISTENING IN AND HEARING
YOUR IMPACT AND INPUT AND
INCORPORATING THOSE IN REAL TIME
AND WOULD LIKE TO GIVE US TIME
FOR A QUICK BREAK. WE ARE
AMAZINGLY A LITTLE AHEAD OF
SCHEDULE.
SO, I THINK THAT WE CAN GIVE
OURSELVES 10 MINUTES OR 11
MINUTES.
WE CAN BE BACK AT 1 P.M. MY
TIME.
THANK YOU, AGAIN. WITH WE COME
BACK WE WILL TALK ABOUT
THERAPEUTIC DEVELOPMENT AND WILL
SWITCH GEARS AND LOOK ACROSS
BOTH PAIN AND ADDICTION AND LOOK
AT HEAL INVESTMENT PORTFOLIO AND
ALL OF THE ONGOING AND PROPOSED
RESEARCH TOGETHER. NORA, YOU
HAVE YOUR HAND RAISED. MAKING
SURE YOU DON'T HAVE FINAL
COMMENTS BEFORE WE GO OFF TO
BREAK?
>>NO. JUST THAT I NEED TO
LOWER IT. BREAK IS PERFECT.
THANKS.
>>THANKS, EVERYONE.
SEE YOU IN 10 MINUTES.
HUGE FOCUS SINCE BEGINNING IS
DEVELOPMENT OF NOL ELAND USER
FRIENDLY TREATMENT OPTIONS AND
REVERSAL OF OVERDOSE AND WE ARE
FORTUNATE TO HAVE TWO DEDICATED
AND AMAZING RESEARCHERS CO-C
CO-CHAIRING THE SCIENTIFIC TEAM
DRIVING FORWARD RESEARCH FOR
AREA OF HEAL AND NIDA I CALL IT
NIAID.
KENT NER IS HERE WALKING US
THROUGH WHAT THE TEAM HAS PUT
FORWARD FOR CONSIDERATION FOR
UPCOMING FISCAL YEAR. NEXT
SLIDE, PLEASE.
I WILL DO WHAT I DID BEFORE THAT
IS TO PUT IN CONTEXT PROPOSED
RESEARCH AT THE BOTTOM HERE
CLINICAL ASSESSMENTS FOR DRUG
DEVELOPMENT TO BE SOMETHING
INCORPORATED INTO WHAT YOU SEE
AS A VERY BROAD AND DEEP SET OF
RESEARCH INVESTMENTS FOCUSED ON
IMMUNOTHERAPIES AND DEVELOPMENT
FOR OPIOID USE DISORDER AND
LARGE NUMBER OF MEDICATION AND
THERAPE
THERAPEUTIC-FOCUSED PROGRAMS AND
RESEARCH FOCUSED IN THE MIDDLE
FOCUSING ON STIMULANT DISORDERS
AND FOCUSING ON SPECIFIC
THERAPEUTICS AND NEW CATEGORIES
OF THERAPEUTICS FOR TREATMENT OF
SUBSTANCE USE DISORDER AND THOSE
ARE NOW IN THE MRANLING PHASE
INCLUDING MENTAL HEALTH
CONDITIONS TOGETHER WITH OPIOID
USE DISORDER AND EMERGING
THREATS AND ORAL COMPLICATES AND
OTHER MEDICATIONS FOR THE
TREATMENT OF OPIOID USE
DISORDER. SO, I WILL STOP THERE
AND TURN IT OVER TO YOU, KENT
NER. NEXT SLIDE, PLEASE.
>>THANK YOU, DR. BAKER.
SO, AS A REMINDER AND AS REBEKAH
SAID, CHARGE FOR OUR TEAM IS TO
REALLY EXPAND THERAPEUTIC
OPTIONS FOR TREATMENT OF OPIOID
AND STIMULANT USE DISORDERS THAT
OUR GOAL IS TO ACCELERATE
DEVELOPMENT FOR TREATMENTS FOR
ALL ASPECTS OF ADDICTION CYCLE
INCLUDING PROGRESSION OF CHRONIC
USE AND WITHDRAWAL SYMPTOMS
CRAVINGS AND OVERDOSE AND THRU
INITIATIVES LISTED ON PREVIOUS
SLIDE THAT REBEKAH MENTIONED AND
KEY POINT IS THAT WHEN WE
STARTED INITIAL GOAL IS TO HAVE
15IMDS FILED WITHIN FIRST 5
YEARS OF HEAL AND CURRENTLY
SUPPORTED FILING OF 34INDS AND
23 OF THOSE ARE CURRENTLY ACTIVE
AND NUMBERS ARE ACTIVELY GROWING
AND FY24 CONCEPT IS A LITTLE
DIFFERENT IN THAT IT REALLY IS
TO SUPPORT ACTIVITIES GETTING
IND EXPANDING UPON REGULATORY
RESOURCES AND DRUG DEVELOPMENT
TOOLS TO BE AVAILABLE FOR
INVESTIGATORS TO USE.
SO, CONCEPT OF PROPOSED IS
TITLED HERE AND SUPPORT OF
DEVELOPMENT OF CLINICAL OUTCOME
ASSESSMENTS AS FDA QUALIFIED
DRUG DEVELOPMENT TOOLS TO
ACCELERATE DEVELOPMENT OF
THERAPEUTICS TO TREAT OPIOID
SIMILAR TO USE DISORDER AND
CONCEPT INITIATED AND DEVELOPED
BY DR. RAMI WHO PUT TREMENDOUS
THOUGHT AND WORK INTO THIS
CONCEPT AND WE APPRECIATE IT.
THANK YOU. SHE IS ON THE CALL
AND WILL ANSWER ANY QUESTIONS
YOU HAVE ABOUT THE INITIATIVE.
WITH THAT, GOING TO THE NEXT
SLIDE.
>>A CONCERN WE HEARD THROUGH
COMMUNITY IN WORK WE SUPPORT IS
A QUALIFIED CLINICAL OUTCOMES
ASSESSMENTS RECOGNIZED AND
ACCEPTED BY FDA.
THAT IS REALLY CRITICAL FOR
TOOLS TO BE BY USE FOR
INVESTIGATORS AND FOR EXAMPLE
HELPFUL FOR INVESTIGATORS TO
HAVE A TOOLSET AND FDA
RECOGNIZED OUD SEVERITY CLINICAL
ASSESSMENT SCALE BASED ON DSM-5
CRITERIA AND EXAMPLE TO HAVE FDA
RECOGNIZED EVALUATIVE TOOL FOR
ASSESSMENT OF OPIOID CRAVINGS
FOR PATIENT REPORTED OUTCOMES
AND FDA RECOGNIZING QUALIFIED
DRUG DEVELOPMENT TOOLS
INVESTIGATORS CAN RELIABLY USE
AS TRIAL DESIGN ELEMENTS WOULD
REMOVE UNCERTAINTY THAT CAN BE
INVOLVED WITH IND SUBMISSION
THAT WOULD END UP SPEEDING UP
THE REGULATORY PROCESS.
MEETING THE NEED THIS CONCEPT IS
BUILT AROUND ADVANCING CLINICAL
ASSESSMENTS OR CLINICAL OUTCOME
ASSESSMENTS THROUGH FDA DRUG
DEVELOPMENT TOOL QUALIFICATION
PATHWAY AND PROPOSING TO USE
UG3UH3 PHASE MECHANISM WHERE
THAT TRANSITION MILESTONE IS
SUBMISSION AND ACCEPTANCE OF
LETTER OF INTENT TO THE FDA AND
AT THAT POINT PROPOSED CLINICAL
ASSESSMENTS QUALIFY THAT PROGRAM
AND UH3 SECOND PHASE OF THE
PROJECT IS FOCUSED ON RESPONDING
TO FDA'S ADVICE LETTER ADVANCING
CLINICAL ASSESSMENT TOWARDS
QUALIFICATION OF AN ACCEPTED
DRUG DEVELOPMENT TOOL. NEXT
SLIDE.
LET'S SEE HOW CONCEPT FITS WITH
HEAL AND ADVANCING PROGRAM AND
HAVING A SET OF FDA RECOGNIZED
DRUG DEVELOPMENT TOOLS IS
SIGNIFICANTLY HELPFUL AND
INDIVIDUAL INVESTIGATORS ACROSS
THE PROGRAM THAT WOULD SUPPORT
ONGOING SOLICITED PROGRAMS
THROUGH HEAL AND THERE IS A
SIGNIFICANT NEED HERE AND
PRODUCTS FROM CONCEPT WILL
SHORTEN EFFORT NEEDED AT KEY
STAGES OF CLINICAL DEVELOPMENT
REDUCING UNCERTAINTY OF THAT
SUBMISSION AND REGULATORY
PROCESS AND PROGRAM IS BUILT
WITH INTERACTIONS AROUND FDA AND
WE ANTICIPATE THIS CONCEPT HAS A
SIGNIFICANT IMPACT EXTENDING
WELL BEYOND THE HEAL PROGRAM.
NEXT SLIDE, PLEASE.
FOUR QUESTIONS HERE FOR
DISCUSSION.
BASICALLY, WHAT IT COMES DOWN TO
IS WE ARE LOOKING FOR FEEDBACK
FROM YOU ON HOW TO BEST FOCUS
ADVANCES CONCEPT SO WE CAN HAVE
LARGEST AND GREATEST IMPACT IN
THE COMMUNITY AND WITH THAT IN
MIND, THANK YOU. WE WILL OPEN
IT UP FOR DISCUSSION.
THANK YOU KENTNER. CHRISTIAN
HAS HIS HAMMED RAISED. GO RIGHT
AHEAD.
>>THANK YOU FORTHAT. THIS IS A
VERY, VERY IMPORTANT PROJECT AND
REASON FOR THAT IS IN MY OPINION
IT IS THAT YOU CANNOT REALLY
FIND RECOVERY IN TERMS OF
ABSTINENCE ONLY.
I THINK THAT IT IS TIME TO MOVE
FAR BEYOND JUST ABSTINNANCE. I
WOULD LIKE TO MAKE THREE
COMMENTS HERE AND FIRST IS ABOUT
HARM REDUCTION AND THINK THERE
IS A LOT OF THINGS WE CAN LEARN
FROM ALCOHOL USE DISORDER.
AS YOU KNOW THE FDA HAS EVOLVED
THE FIELD A LITTLE BIT BY ADDING
NO HEAVY DRINKING DAYS IN
ALCOHOL USE DISORDER AND WOULD
ARGUE THIS IS RELATIVELY NARROW
AND INSENSITIVE SINCE IT IS
BASICALLY CLASSIFYING PATIENTS
AS TREATMENT FAILURES AFTER ANY
HEAVY DRINKING DAYS.
SO, WHILE WE -- WHILE SOME OF
THE PATIENTS HAVE SUBSTANTIALLY
REDUCED THEIR DRINKING AND
IMPROVE HOW THEY FEEL AND HOW
THEY FUNCTION IN LIFE IN
GENERAL.
SO, AS YOU KNOW, THE EUROPEAN
MEDICINES AGENCY HAS NOW
ACCEPTED AS OUTCOME TWO-LEVEL
REDUCTION IN WHO FOR LEVEL
CLASSIFICATION OF RISK DRINKING
LEVELS AND THINK THAT A GROUP
LIKE ACTIVE GROUP HAS BEEN
WORKING ON VALIDATION OF THIS
FOR THE LAST 10 YEARS AND IS A
GOOD EXAMPLE AND THIS IS FOR
ALCOHOL USE DISORDER. I SEE IT
AS VERY VALUED APPROACH AND FOR
EXAMPLE FOR CANNABIS USE
DISORDER AND FORMS OF SUBSTANCE
USE DISORDER AND SECOND POINT TO
MAKE IS ABOUT CRAVING THAT IS A
VERY INTERESTING SITUATION WHERE
THERE HAS BEEN AN INCENTIVE FOR
US TO DEVELOP CREATING
MEDICATIONS WHILE CREATING IS
NOT RECOGNIZED VALUE TO
RECOGNIZE THE ENDPOINT IN OUR
REGULATORY TRIALS.
SO, I THINK THAT ANYTHING WE CAN
DO, IN ORDER TO VALIDATE NEW
CRAVING TOOLS THAT WOULD BE
ACTUALLY ACCEPTED BY FDA NOT
ONLY AS NICE TO HAVE ENDPOINT
BUT PRIMARY ENDPOINT MAKING SURE
WE ACTUALLY LINK ANTI-CRAVING
EFFECTS TO DRUG USE PATTERNS IS
GOING TO BE REALLY CRITICAL.
THIRD POINT THAT I WANTED TO
MAKE IS REALLY RELATED TO
QUALITY OF LIFE THAT TODAY STILL
SEEMS AS NICE TO HAVE AS PART OF
THE CLINICAL TRIALS THAT IN MY
OPINION REALLY NEEDS TO CHANGE.
WE NEED TO MAKE SURE THAT
QUALITY OF IS PRIMARY ENDPOINTS
AND REASON FOR THAT IS RECOVERY
AS I SAID IS NOT ONLY ABOUT
ABSTINENCE BUT MENTAL HEALTH,
PHYSICAL HEALTH, EMPLOYMENT
RATES AND SIGNIFICANTLY
DECREASING HEALTH RESOURCE
UTILIZATION AND IN OTHER WORDS
CONSTELLATION OF FACTORS
CURRENTLY NOT BEING CONSIDERED
IN CLINICAL TRIALS OR NOT AS
PRIMARY ENDPOINTS THREE MAIN
POINTS FROM ME HARM REDUCTION
CRAVING AND QUALITY OF LIFE IS A
MUCH BROADER DEFINITION WHAT
RECOVERY IS ALL ABOUT.
>>THANK YOU CHRISTIAN AND THANK
YOU KENT NER.
NORA WOULD YOU LIKE TO GO FOR OR
GO THROUGH DISSENTS AND WEIGH
IN.
>>LET ME GO FIRST. IT IS
SPECIFIC POINT AND FEEDBACK TO
CHRISTIAN WE HAD TWO MEETINGS
WITH FDA TO SPECIFICALLY DISCUSS
EXPLICIT WILL I CRAVING. YOU
SAW METAANALYSIS CRAVING PAPER
ON [INDISCERNIBLE] SHOWING HOW
REGARDLESS HOW CRAVING IS
ACTUALLY MEASURED OR RELEASED IT
IS A RELIABLE AND SIGNIFICANT
PREDICTOR OF RELAPSE AND DRUG
TAKING AND SENT PAPER TO FDA
SAYING TO ME THAT METAANALYSIS
SHOWS EVIDENCE IT IS A VALID
BIOMARKER. WE MET TWICE TO TRY
TO FIGURE OUT IF THIS WAS GOING
TO BE ACCEPTABLE FOR THEM.
STATUS RIGHT NOW IS THEY ASK US
TO ORGANIZE A MEETING WITH --
THEY WILL BE PARTICIPATING TO BE
ABLE TO VERY EXPLICITLY IDENTIFY
WHAT IT IS THAT THEY WILL
CONSIDER SUFFICIENT EVIDENCE.
SO, THIS IS THE FIRST
ALTERNATIVE OUTCOME THAT WE ARE
TRYING TO PUSH FORWARD BECAUSE
OF TREMENDOUS RELEVANCE AND WE
WILL INFORM YOU WHEN WE KNOW
THAT MEETING WILL HAPPEN. ALSO,
AS YOU KNOW THEY COME UP WITH
GUIDELINES FOR PEOPLE THAT --
FOR THOSE TRYING TO DEVELOP
MEDICATIONS FOR OPIOID USE
DISORDER.
BASICALLY ALTERNATIVE OUTCOMES
ARE LISTED. IT IS VERY UNCLEAR
TO ME THAT THEY ARE SEEING IT AS
SECONDARY OUTCOMES NOT AS MAIN
OUTCOMES AND WE -- WHAT WE NEED
TO TRY TO GAIN IS AN
ALTERNATIVELY MAIN OUTD COME
THAT FDA WANTS TO MOVE THAT WILL
FACILITATE ENORMOUSLY
DEVELOPMENT OF MEDICATIONS.
SO, IN THAT RESPECT I'M OF
COURSE VERY SUPPORTIVE OF THESE
PROPOSAL FROM TANYA AND WE HAVE
BEEN SUPPORTING IT BEFORE HAND
AND FOR SEVERAL YEARS NOW
ACTUALLY.
SO, YES. INDEED, THIS HAS BEEN
A MAJOR CHALLENGE AND ROAD
BLOCK.
IT IS AN AREA THAT IF WE CAN
SOLVE, WE ARE FACILITATING NOT
JUST DEVELOPMENT IN GENERAL BUT
FOR US TO SUCCEED GETTING
MEDICATIONS THAT ARE VALUABLE IF
THEY DON'T PRODUCE COMPLETE
ABSTINNANCE.
>>THANK YOU, NORA. NED, YOUR
HAND IS RAISED.
>>SURE. CHRISTIAN LIKE YOUR
WAY OF LOOKING AT IT HARM
REDUCTION AND CRAVE IING AND
QUALITY OF LIFE AND MEASURES OF
FUNCTIONING AND MAKE A COUPLE
POINTS ABOUT IT.
ONE, THE -- I DON'T SEE IT
TALKED ABOUT MUCH. THE OUTCOME
AND RIGHT OUTCOME DEPENDS TO AN
EXTENT WHAT THE TREATMENT DOES.
SO, THOSE THAT GAVE NAL TRAVEL
YOENS TO PATIENTS WITHOUT
ALCOHOL USE DISORDER REDUCING
HEAVY DRINKING IS WHAT NAL
TRECHL YOEN DOES AND DOESN'T
PROMOTE ABSTINNANCE. IF YOU USE
ABSTINNANCE OUTCOME ON NAL
TRECHL YOEN TRIAL YOU ARE LESS
LIKELY TO SEE THE EFFECT. THAT
IS NO THE WHAT IT REALLY DOES.
IT MAKES IT SO ALCOHOL IS NOT
REWARDING ANYMORE AND PATIENTS
STILL DRINK BUT NOT HEAVILY AND
[INDISCERNIBLE] AND IN OPIOID
USE DISORDER FIELD PATIENTS
DON'T USE OPIOIDS MUCH RECEPTORS
ARE BLOCKED AND DON'T USE
OPIOIDS AND SAME MIGHT BE TRUE
OF BU PREN OR FRIN IF YOU GET
DOSE HIGH ENOUGH AND SHOULD
THINK ABOUT WHAT IS NOT JUST THE
BEST OUTCOME FOR EVERY TREATMENT
BUT BEST OUTCOME GIVEN WHAT WE
KNOW ABOUT MECHANISM OF
TREATMENT AND WHAT WE THINK IT
DOES CLINICALLY. I GUESS MY
SECOND POINT WOULD BE THAT IN
OTHER FIELDS THINKING OF
PROXIMAL AND DISTAL OUTCOMES AND
REDUCING CHOLESTEROL PROXIMAL
OUTCOME AND DISTAL OUTCOME IS
HEART ATTACKS AND STROKE AND
WONDER IF THERE IS ANALOGY HERE
WHERE YOU PROBABLY HAVE TO
REDUCE DRUG USE TO GET
IMPROVEMENTS IN QUALITY OF LIFE,
I THINK.
SO, I WONDER ABOUT THINKING
ABOUT IT IN THOSE TERMS AND WHAT
IS A PROXIMAL OUTCOME AND MORE
DISTAL OUTCOME?
MY THIRD POINT WOULD BE THAT
QUALITY OF LIFE IS HARDER TO
MEASURE AND TYPICAL MEASURE
THAT, YOU KNOW, WE USE IS EDQ.
YOU KNOW, THE -- THE EDQ5 WHICH
IS A TERRIBLE MEASURE FOR
ADDICTION OR MENTAL HEALTH AND
DOESN'T REALLY CAPTURE AND
CAPTURES WHETHER YOU CAN WALK
AND FEED YOURSELF AND DOESN'T
CAPTURE THE FUNCTIONING THAT WE
CARE ABOUT.
WALTER LING DEVELOPED SIMPLE
TREATMENT EFFECTIVENESS
EVALUATION ASSESSMENT THAT I
LIKE THAT IS VERY SIMPLE AND
GETS MORE AT FUNCTIONING THAT WE
ARE TALKING ABOUT WITH PEOPLE
WITH MENTAL HEALTH AND SUBSTANCE
USE. ARE YOU FUNCTIONING AS A
FAMILY MEMBER AND DOING THINGS
IN YOUR COMMUNITY AND ENGAGED IN
POSITIVE ACTIVITIES AND SO
FORTH?
SO, THOSE ARE MY COMMENTS.
>>THANK YOU, NED. GAIL?
>>JUST GOING TO SAY I PUT MY
HEAD UP AS NED SAID THAT.
I LIKE WALTER LINK'S TEA AND
QUESTION SUBSTANCE THAT IS
RELATING TO YOUR FAMILY AND
COMMUNITY AND ARE YOU BACK AT
WORK?
TRYING TO INCORPORATE IT INTO
SOME STUDIES AND AGREE WITH YOU
THAT IS WHAT WE NEED TO KNOW;
RIGHT?
YOU DRINK LESS, OKAY. RIGHT.
ARE YOU THEN ABLE TO OR STAYING
WITH YOUR FAMILY AND DO YOU HAVE
A SIGNIFICANT OTHER OR FRIENDS
OR DO YOU GO TO WORK?
THESE ARE IMPORTANT ISSUES THAT
FAIRLY IS SIMPLISTIC THE TEA IT
IS NOT. IT LOOKS LIKE IT. IT
IS FOUR QUESTIONS AND AGREE WITH
YOU THAT EQ OR WHATEVER WE USE
THAT IS WORTHLESS.
I THINK THAT TEA, YOU SHOULD
LOOK TOWARDS THAT. IT IS GREAT.
NOW, ROB, ARE YOU IDENTIFIED AS
A DISCUSSANT AND I DON'T AND
THOUGHT HAND WAS RAISED BUT
MAYBE.
>>[INDISCERNIBLE].
>>NORA ADDRESSED QUESTIONS I
HAVE HAD. I THINK THAT THIS
SEEMS LIKE AN OBVIOUSLY
IMPORTANT THING TO DO OUTSIDE OF
MY AREA OF EXPERTISE AND MEETING
RIGHT [INDISCERNIBLE] FOR TRIALS
AND POINT ABOUT WHAT IS GOAL OF
THE MEDICATION THAT IS SUPER
IMPORTANT.
>>THANK YOU. NED?
>>I WAS GOING TO ASK. WHAT
KINDS OF STUDIES ARE YOU
ENVISIONING AND WHAT KINDS OF
DATA ARE YOU ENVISIONING
COLLECTING OR LOOKING AT OR
MAINLY SECONDARY ANALYSIS OR
INFLUENCING MEASUREMENT PLANS
FOR TRIALS THAT WILL GET
INITIATED SOON OR WHAT -- WHAT
ARE YOU THINKING THERE?
>>WELL, FIRST ONE, NED, TO ME,
IT WAS TO DO OR LOOK AT TATE AH
WE HAVE IN REPOSITORY FOR
CLINICAL TRIALS FROM CTN AND
FROM MEDICATION DEVELOPMENT.
TO ACTUALLY UNDERSTAND IF A
PARTICULAR MEDICATION THAT WAS
BEING TESTED. EFFECTED CRAVING
AND NOW WE ARE FOCUSING ON
CRAVING AND WHETHER IT IN TURN
IS ASSOCIATED IN LONG-TERM TO
POSITIVE OUTCOME. I HEARD FROM
FDA THAT YES. THIS PAPER DOES
SHOW IT. IT IS PRETTY STRONG
EVIDENCE THAT CRAVING IS
PREDICTOR.
IT IS NOT PRESENTING IT IN
CONTEXT OF A CLINICAL TRIAL.
UH-HUH.
>>I THINK WE CAN CONSOLIDATE
IT. THEN WHAT I WOULD LIKE
ABOUT IT AND I -- AS YOU WERE
SPEAKING ABOUT PROXIMAL VERSUS
DISTANT INDICATOR AND ELEMENT
THAT IS VALUABLE IS HAVING AN
EARLY INDICATOR THAT A
PARTICULAR THERAPEUTIC PROMISED
LOOKING AT IT IN MOLECULES AND
COMING FROM CLINICAL WORLD AND
HAVING A PROXIMAL INDICATOR WITH
A STRONG PREDICTION ON LONG TERM
THAT WOULD BE VERY VALUABLE FOR
ALL OF US.
>>UH-HUH.
>>I THINK THAT IS -- THAT IS
ONE ELEMENT AND OTHER IS IN
TERMS OF DISCUSSION IS WELL SORT
OF WE CAN COME UP WITH VERY
DESIRABLE OUTCOMES AND JUST
IMPROVEMENT ON QUALITY OF LIFE
OR WELLBEING OF INDIVIDUAL OR
ONE THAT TANYA IS PUTTING
FORWARD IN TERMS OF IMPROVEMENT
ACROSS VARIOUS DOMAINS THAT
WOULD BE VALUABLE.
FDA AS YOU IS CHAL EFRNGSING AND
THEY ARE REGULATIONS AND WE ARE
FOLLOWING ELECTRONIC RECORDS AND
LOOKING AT ALSO WHETHER WE CAN
INFORM FROM THEM AND FROM
DATABASES IN MEANTIME WE ARE
FUNDING RESEARCHERS NOW FOR MANY
YEARS TO ACTUALLY DOCUMENT TO US
THAT IF YOU HAVE AN INTERVENTION
THAT REDUCES AMOUNT OF DRUG
CONSUMED THIS IS A HEALTH
BENEFIT FOR THE INDIVIDUAL THAT
IS, FOR EXAMPLE, THE CASE FOR
COCAINE USE DISORDER WHERE YOU
ARE ABLE TO SHOW THAT AMOUNT OF
COCAINE THEY TAKE GOES DOWN
CARDIOVASCULAR PHYSIOLOGY
SIGNIFICANTLY IMPROVES AND WE
ARE FUNDING RESEARCHERS WITH
DIFFERENT STRATEGIES TRYING TO
GET FDA TO BE OPEN ANDLE TO BE
AN ALTERNATIVE OUTCOME AND WE
HAVE CURRENTLY NOTHING THAT FDA
HAS APPROVED YET AND DOING
STUDIES TO SEE IMPROVING SLEEP
IN PATIENTS WITH OPIOID USE
DISORDER THAT INCREASES
LIKELIHOOD THEY ARE ACTUALLY
ABLE TO FUNCTION PROPERLY THAT
WON'T BE A MAIN OUTCOME FOR FDA.
SO, I AM TRYING TO SEE IF WE CAN
CHANGE THAT SO IT CAN BE A MAIN
O
ONE.
>>OKAY. I THINK WE ARE WITH
MANY, MANY THINGS WITH ALL OF
THE DISCUSSION SUGGESTIONS AND
KENTNER.
>>ONE OTHER THOUGHT. CTM WE
HAVE LARGE CLINICAL TRIALS WITH
LONG-TERM FOLLOW UP IN MEASURE
CRAVING AND SUBSTANCE USE AND
STUFF. IT WOULD BE POSSIBLE TO
LOOK AT SOME OF THESE THINGS IN
DATA THAT ALREADY EXIST.
>>EXACTLY. THAT IS WHAT THEY
ARE DOING AND WE ARE GET
CONTRACT TO BE ABLE TO DO THAT.
>>YEAH.
>>GREAT RESOURCE.
>>PERFECT. OKAY. WE CAN THEN
WITH MANY THINGS TO KENT NER AND
DISCUSSANTS MOVE TO FINAL
PORTION OF AGENDA.
I WILL QUICKLY I WILL TRY TO DO
THIS REALLY QUICKLY AND WE HAVE
USED UP A LOT OF YOUR TIME. WE
ARE VERY FWRATFUL FOR IT.
REVIEW WHAT WE HAVE SHOWN YOU
OVER THE PAST COUPLE WEEKS
STARTING WITH LAST WEEK'S AND
GOING THROUGH YESTERDAY AND
TODAY AND ENDING WITH A PRETTY
HIGH-LEVEL DISCUSSION TOGETHER
WITH NORA AND WALTER ABOUT
OVERALL HEALED RESEARCH
DIRECTIONS AND WHERE YOU THINK
OUR SUSTAINED FOCUS THAT IS MOST
IMPORTANT. NEXT SLIDE, PLEASE.
SO, THIS IS WHERE I STARTED WHEN
I INTRODUCED THE MEETING
YESTERDAY.
WE HAVE -- YOU KNOW, THIS IS A
TERRIFIC GROUP. I HAVE TO SAY
THAT THE DISCUSSION WE HAVE HAD
OVER THE PAST FEW DAYS HAS BEEN
SO WITCH. YOU HAVE REALLY ALL
HAD A TREMENDOUS UNDERSTANDING
OF CHALLENGING WE ARE FACING
TOGETHER AND RESEARCH WE ARE
CONDUCTING TO DO SO. NOW IS THE
TIME THAT WE LOOK TO YOU FOR
HONEST FEEDBACK AROUND HOW ARE
WE DOING?
ARE WE RESPONDING NIMBLY TO
REVOLVING DRIVERS TO OPIOID
CRISIS AND IN 2018 SINCE WE
FIRST LAUNCHED AND DOING THIS
RIGHT NEW EMPHASIS AND
POLYSUBSTANCE USE AND DITCH WAYS
TO CONNECT WITH PEOPLE USING
DRUGS HITTING THE MARK AND WHAT
CHANGES MIGHT BE NEEDED WE ARE
SEEING REGULATORY CHANGES AND
OPIOID PRESCRIBING SGIED
GUIDANCES THAT HAVE EVOLVED AND
THEY HAVE OUR PROGRAMS MET THE
EVOLVING NATURE OF THESE GOALS
A
AND.
WE ALSO DISCUSSED LAST WEEK SOME
RESEARCH LAUNCHED IN 2018 AND 19
AND AT THAT TIME WE HAD A CRISP
VIEW WHAT WAS NEEDED BASED ON
STAKEHOLDER ENGAGEMENT AND HAD A
FEW CORE AIR YAZ OF FOCUS THAT
SINCE EXPANDED GOING BACK TO
TIPS OF THE SPHERE AND HOW THEY
HAVE DONE AND IN WHAT WAY DO
THEY CONTINUE TO REPRESENT
IMPORTANT ONGOING NEEDS FOR HEAL
AND WHAT WAYS THEY HAVE TO
THEMSELVES BE INVOLVED AND
LASTLY MANY DIFFERENT RESEARCH
IDEAS UNDER CONSIDERATION THAT
WE DISCUSSED OVER PAST TWO DAYS
HOW THEY FIT IN AND HOW YOU
WOULD PUT THEM IN PERSPECTIVE OF
LARGER BODY OF ONGOING RESEARCH
THAT HEAL SUPPORTS FROM A
PRIORITIZATION PERSPECTIVE AND
FROM A KIND OF SCIENTIFIC AND
ARE THEY MEETING OR CONTINUING
TO MEET NEEDS PERSPECTIVE AND
NEXT SLIDE, PLEASE STUDY IT ALL
OF THE DIFFERENT COLORS AND 2019
YEAR WAS TWO YEARS THAT IS OFF
BALANCE AND OVERTIME WE HAVE
SEEN EVOLUTION IN WAYS WE MADE
RESEARCH INVESTMENTS FOR
INSTANCE PRECLINICAL AND
TRANSLATIONAL SPACE HAS GROWN ON
PAIN MANAGEMENT SIDE AS WE ADDED
MORE INVESTIGATIONAL AND
TARGETED RESEARCH PROGRAMS TO
CORE SET WE LAUNCHED AND
SIMILARLY IN CROSS-CUTTING AND
CAREER DEVELOPMENT SIDE ON OTHER
SIDE OF THE SPECTRUM WE ADDED
MORE TRAINING AND FIRST WE WERE
PUTTING TOGETHER LARGE AND
AMBITIOUS RESEARCH PROGRAMS AND
WHEN WE DID THAT WE REALIZED WE
DEPLETED A LOT OF THE WORKFORCE
AND THERE WASN'T NECESSARILY A
NEXT GENERATION TO COME REPLACE
THEMENTD INVESTMENTS THERE AND
ON DATA SIDE TAKING FINDINGS
COMING FROM STUDIES DRIVING
FORWARD FOR SUBSTRATE FOR NEW
LINES OF INVESTIGATION AND NEXT
SLIDE, PLEASE.
REVIEW OF SPECIFIC PROGRAMS
DISCUSSED LAST WEEK. NEXT SLIDE
YOU SEE THEM FOCUSED HERE.
SIGNIFICANT INVESTMENTS PREV
PREVENTING USE DISORDER TARRING
ESSING GROUPS AND PARTNERING
WITH FEDERAL AGENCIES
UNDERSTANDING HOW TO MAKE
PREVENTION EFFORTS SUPSTAINABLE
AND TREMENDOUS NUMBER OF
CLINICAL TRIALS AND TOO MUCH TO
GO INTO INTO TAIL THROUGH NIDA
CLINICAL TRIALS AND AS YOU
PROBABLY RECOGNIZE FROM
DISCUSSION WE HAD TODAY WE
CONTINUE TO ADD THEM THAT IS ON
A CASE BY CASE BASIS AND
INFRASTRUCTURE WAS EXPANDED IN
2019 TO SUPPORT NEW STUDIES AND
HAVE TO BE EXPANDED AS WELL AND
TRANSLATION TO RESEARCH PRACTICE
SIDE WE HAVE INNOVATIVE JUSTICE
COMMUNITY OPIOID NETWORK WITH
COMPONENT PARTS SEEKING TO BUILD
PARTNERSHIPS WITH JUSTICE
COMMUNITY AND PROVIDE HEAD
QUALITY CARE TO PEOPLE WHO HAVE
SUBSTANCE USE DISORDER MOVING IN
AND OUT OF JUSTICE COMMUNITY AND
67 COMMUNITIES ACROSS THE
COUNTRY LOOKING TO OVERDOSE AND
WORK ON COMMUNITIES IDENTIFYING
NEEDS PUTTING INTO PLACE FROM
MENU OF EVIDENCE-BASED OPTIONS
AND TARGETED STRATEGIES MEETING
LOCAL NEEDS TO REDUCE OVERDOSE
DAENL AND LASTLY IN BOTTOM OF
SLIDE PRECLINICAL TRANSLATIONAL
SIDE CONTRACTS TO TEST CANDIDATE
THERAPEUTICS AND SUITE OF
PROGRAMS TO ADVANCE INDIVIDUAL
THERAPEUTIC CANDIDATES IN
PIPELINE AND USING RESOURCES AND
NKATS INTRAMURAL PROGRAM AND
THROUGH EXTRAMURAL COMMUNITY WE
BROUGHT TO YOU BEFORE NEXT
SLIDE, PLEASE.
I DON'T THINK I WILL GO THROUGH
ALL OF THEM. GROUP WAS HERE AND
THEY PRETTY MUCH REMEMBER AREA
OF DISCUSSION AND IF YOU WANT TO
GO BACK REVISITING NOTES WE HAVE
FROM THE DISCUSSION LAST WEEK WE
CAN DO SO. FOR 2024 RESEARCH
CONCEPTS THAT IS A TOPIC OF
DISCUSSION YESTERDAY AND TODAY
LOOK AT THIS BEAUTIFUL COLOR
BREAKDOWN AND THANKS FOR HAVING
ME AND TALKED ABOUT ON
PRECLINICAL AND PAIN MANLAGEMENT
SIDE THAT IS IN BLUE AND THIS IS
YESTERDAY'S AGENDA LOOKING AT
INDIVIDUAL DIFFERENCES IN HUMAN
PAIN CONDITIONS AS WELL AS
EFFECTS OF EXPOSOME ON ACUTE
PAIN AND LONGITUDINAL OR
MECHANISTIC STUDIES AND
WORKFORCE AND DEVICE-BASED SLEEP
AND MIOFACIAL PROJECTS FOCUSING
ON ASPECTS OF PAIN AND WHAT WE
CAN LEARN CONSIDERING ADDITIONAL
ELEMENTS OF PAIN EXPERIENCE.
WE THEN SWITCH GEARS THIS
MORNING TALKING ABOUT IMPORTANCE
OF OPIOID USE DISORDER AND
ALCOHOL USE DISORDER
CO-OCCURRENCE AND POPULATIONS WE
SERVE AND WE LOOKED AT A COUPLE
OF DIFFERENT APPROACHES TO
TRANSLATE RESEARCH TREATING
OPIOID REQUEST USE DISORDER INTO
PRACTICE LOOKING AT HOSPITAL
SETTING AND LOOKING AT SPECIFIC
POPULATIONS LIKE WOMEN POST
PARTIUM AND IMMEDIATE FAMILY AND
WE SWITCHED TO THE CLINICAL
TRIALS WITHIN NIDA CLINICAL
TRIALS WE DISCUSSED AND ENDED
WITH A FOCUS ON HOW
UNDERSTANDING REGULATORY
FRAMEWORK AND OUTCOMES THERE
COULD ADVANCE BODY OF MEDICATION
ANDTHERAPIEUTIC DEVELOPMENT
PROGRAMS IN HEAL AND NEXT SLIDE,
PLE
PLEASE.
ENHANCING PAIN MANAGEMENT IS
FIRST ANDALITY THIS POINT I WILL
ASK WALTER TO JOIN ME IN
FACILITATING A DISCUSSION AROUND
ALL DIFFERENT PAIN INVESTMENTS
WE MADE SO FAR.
WHAT IS NEXT SLIDE?
YOU HAVE SEEN THIS ALREADY. IT
HAS MANY DIFFERENT PAIN
THERAPEUTIC AND PRECLINICAL
TRANSLATIONAL RESEARCH PROGRAMS
AS WELL AS SMALL NUMBER PROPOSED
AT VERY BOTTOM AND RANGES FROM
TARGET DISCOVERY INVALIDATION TO
MORE TEAM BASED ANALGESIC
DEVELOPMENT PROGRAMS TO DEVICE
BASED APPROACHES ADDITIONAL
ANIMAL MODELS FOR PAIN AND
INTEGRATION OF CLINICAL TEAMS
AND NEXT SLIDE, PLEASE.
ON CLINICAL SIDE, FIRST TRAUFRNL
OF CLINICAL TRIAL NETWORKS AND
COLLABORATIVES THAT WE CREATED
AT BEGINNING OF HEAL AND
ADDITION OF EMPOWER TO ADDRESS
NEEDS OF PEOPLE WHO HAVE A
SUBSTANCE USE DISORDER AND ALSO
PAIN AND BIOMARKERS HEALTH
EQUITY RELATED RESEARCH AND THEN
JUST MOST RECENTLY A NEW FOCUS
ON PAIN ASSOCIATED WITH SICKLE
CELL AND IN NEURAL POPULATIONS
AND AT BOTTOM RESEARCH PROPOSED
TO ADD INTO THIS PORTFOLIO.
NEXT SLIDE, PLEASE.
WALTER, I WILL TURN IT OVER TO
YOU AND ASK FOR POINTED
QUESTIONS AND AREAS FOR
DISCUSSION FOR
MULTI-DISCIPLINARY GROUPS.
>>THANK YOU, BECCA. THESE ARE
PROGRAMS WE TALKED ABOUT IN
THESE TWO SESSIONS AND
PRECLINICAL SCREENING PLATFORM
THAT IS OPENED FOR ANYBODY TO
COME IN TESTING ASSETS HIGHLY
REPRODUCIBLE ANIMAL MODELS AND
FEEDBACK IN CONCERT WITH
DEVELOPMENT ANIMAL MODELS AND
RFAO FOR THAT PURPOSE AND WENT
THROUGH NCATS PROGRAM THAT IS OR
HAS REAL ADVANTAGES IN TERMS OF
THINGS TO DO WITH INTRAMURAL
RESOUR
RESOURCES.
I WILL GO INTO THAT MORE IN A
SECOND IN TERMS WHAT THOSE
DIFFERENT COMPONENTS ARE.
NEW WITH ONES ARE THINGS THAT
SEEM TO US TO BE KIND OF
NO-BRAINERS AND ARE THINGS TO DO
AND MAYBE WE DIDN'T DO THEM YET.
SOME ARE HARD AND PARTICULARLY
HUMAN PAIN CONDITIONS IN C
COMORBIDITIES AND SO MANY THINGS
INTO PLAY WITH PERCEPTION OF
PAIN NOT NECESSARILY SENSATION
AND MAYBE THERE BUT NEW IT WAS
IMPORTANT BECAUSE IF YOU LOOK AT
THIS I MENTIONED BEFORE LOOKING
AT DATA PEOPLE WITH SEVERE
CHRONIC PAIN HAVE A LARGE NUMBER
OF MEDICAL CO-MORBIDITIES AND
PSYCHIATRIC COMORBIDITIES AND
TRYING TO TREAT JOINT AND NOT
PAYING ATTENTION TO OTHER ISSUES
WE WON'T HAVE IMPACT WE WANT FOR
PEOPLE WE ARE TRYING TO HELP
EXPOSOME, WE THERE ARE OPENING
UP A BOX AND GENOME IN BOX AND
SELECTIVE WHAT WE STUDY SO WE
DON'T DO ENTIRE OCEAN AND TRYING
TO PICK OUT SOME THINGS THAT
PEOPLE ARE EXPOSED TO
PREDISPOSING THEM TO REAL
DISABILITY FUNCTIONAL LOSS DOO
YOU TO CHRONIC PAIN IN FUTURE
AND YOU KNOW IMPORTANCE OF THOSE
ARE THOSE ARE WHAT YOU CAN
POTENTIALLY INTERVENE ON
PREVENTING SOMEBODY FROM GOING
INTO THAT STATE.
WHAT THEY ARE WHETHER EXPOSURE
TO CERTAIN PAIN CONDITIONS AS A
KID AND CERTAIN DRUGS AS A KID
OR CERTAIN OCCUPATIONAL
EXPOSURES AND THESE HAVE NOT
REALLY BEEN LOOKED AT CAREFULLY
WITH A BIG IMPACT TO FIND
SOMETHING THAT IS ACTIONABLE.
WE TALKED YESTERDAY ABOUT FACT
THERE IS A DIRTH OF KNOWLEDGE OF
TREATING CHILDREN WITH DIFFERENT
PAIN CONDITIONS AND HEARD PEOPLE
OR KIDS WITH CERTAIN CONDITIONS
HAVE HORRIBLE PAIN EVERY DAY.
IT DRIVES US TO UNDERSTAND HOW
TO DO BETTER THERE.
ISSUES OF WORKFORCE WE TALKED
ABOUT THAT BEFORE AND WE HAVE TO
DO THINGS TO CREATE PAIN
WORKFORCE AND THERE IS NO
INSTITUTE FOR PAIN LIKE THERE IS
FOR DRUG ABUSE.
ACTUALLY, HEAL IS REALLY THE ONE
SHOP IN TOWN THAT CAN BUILD A
SIZABLE WORKFORCE TO ATTACK
PROBLEMS WE KNOW ARE SO
IMPORTANT AND DEVICES TALKED
ABOUT FROM THE BEGINNING IN
TERMS OF BIOMARKERS THAT HAVE
PAIN THAT CHANGES PEOPLE'S
BEHAVIORS AND CHANGES IN
BEHAVIORS ARE LIKE WILL I TO BE
ABLE TO BE CAPTURED.
THEY CAN BE WITH CURRENT DEVICES
OR MAYBE SOME, YOU KNOW, MORE
NOVEMBEREL DEVICES AND THAT
COULD SERVE AS A -- YOU KNOW, AS
SOMETHING THAT COMPLIMENTS THE
PERSON'S REPORT OF THEIR
PERCEPTION OF PAIN AND MAYBE
POTENTIALLY SOMETHING THAT MAY
BE MORE AMENABLE TO LOOK AT
CHAIVENGS RELATED TO
INTERVENTIONS SUCH AS DRUGS OR
NON-PHARMACOLOGICAL
INTERVENTIONS AND SLEEP AS AN
INTERVENTION TARGET IS RISING TO
THE TOP. ACTUALLY IT ROSE TO
THE TOP EVENTUALLY WITH OPIOID
ON THE OPIOID SIDE AND CLEARLY
SLEEP AND PAIN AND USE OF
MEDICATIONS FOR SLEEP AND PEOPLE
HAVE PAIN IS INCREDIBLY COMMON.
THEN DR. LANGEVIN HAS BEEN A
CHAMPION FOR OPENING OUR EYES TO
THIS AREA OF PAIN RESEARCH THAT
HAS BEEN NEGLECTED THAT IS THE
MIOFACIAL STRUCTURES AND HOW
INJURY THERE CREATES PAIN AND
INTERVENTIONS IN THE SPACE MAY
LEAD THINGS AND THEY ARE THINGS
WE TALKED ABOUT. I THINK MY
BUCKET SLIDE IS NEXT; RIGHT?
WHAT I TRIED TO DO IS TO
CERTAINLY WE ARE INTERESTED IN
COMMENTS WE TALKED ABOUT WITH
REGARDS TO ACTIONAL ITEMS COMING
INTO MWGP THIS TIME AND THINKING
ABOUT SPECTRUM WHAT WE ARE DOING
IN HEAL.
WHAT I TRIED TO DO HERE IS
CREATE THREE BUCKETS
CHARACTERIZED HERE AND
DEVELOPMENT OF NONADDICTIVE
THERAPIES AND NOVEMBEREL
THERAPIES.
SECT ONE IS USING WHAT WE KNOW
AND HAVE AVAILABLE USING
OPTIMALLY MAXIMIZED FUNCTION
WITH PEOPLE WITH PAIN OR EXPOSED
TO PAIN AND THIRD BUCKET IS KIND
OF THINGS THAT WE ARE DOING TO
KIND OF GROW ECOSYSTEM OF PAIN
RESEARCH I MENTIONED.
HEAL HAS AN OPPORTUNITY TO DO
THIS AND TAKES PLACE OF
INSTITUTE FOR PAIN.
I WOULD BE INTERESTED IN
PEOPLE'S IDEAS ON THREE BUCKETS
THAT ARE THINGS WE SHOULD BE
DOING IN ANY THREE AREAS WE ARE
NOT DOING. THEN FROM WHAT YOU
KNOW ARE THINGS WE ARE DOING.
YOU DON'T THINK THEY ARE HIGH
PRIORITY AND WE BUILT IT OVER
TIME AND KIND OF A LONG-TERM
PLAN WITH PIECES COMING IN AND
OUT AND THINK THESE THREE
BUCKETS WILL REMAIN OVER THE
LONG RUN HAPPY TO CALL ON PEOPLE
IF NO ONE RAISES THEIR HAND.
ROB? OH, WELL LINDSAY IS HERE
AND LINDSEY AND DO YOU HAVE
ANYTHING TO COMMENT ON? HELEN
IS HERE AND.
>>YEAH. THANK YOU FOR GREAT
SUMMARY AND NICE WAY TO THINK
ABOUT THESE IN TERMS OF BUCKETS
THAT WE HEARD A LOT OF EXCITING
PROPOSALS AND ALL OF WHICH HAVE
A LOT OF MERIT OF COURSE. I
HOPE THERE WILL BE ENOUGH
RESOURCES SO ALL CAN BE LAUNCHED
WHEN WE WOULD LIKE THEM TO I
WANT TO HIGHLIGHT AGAIN WHAT WE
HEARD FROM OTHERS THAT IS A HUGE
GAP AND OPPORTUNITY TO ADDRESS
WHAT IS REPRESENTED IN THE SET
THAT IS CHILDREN IN ADOLESCENCE
WITH PAIN THAT CRIES OUT TO ME
SOMETHING WHERE WE HAVE A VERY
BIG GAP AND ALL HAVE MERIT.
YOU NO SNE.
THAT IS ONE POINT I WOULD LIKE
TO HIGHLIGHT RECOGNIZING THAT
ALL OF THESE ARE EXCITING AND
WILL CONTRIBUTE TO THIS FIELD
MOVING FORWARD.
>>COMMENTS?
>>SURE. I LIKE THE DISCUSSION
TODAY AND YESTERDAY AND SEEMS
THERE IS A REOCCURRING THEME
THAT WE ARE MOVING TOWARDS MORE
INTEGRATION AND IN TERMS OF
CONNECTING THINGS.
>>HERE HELEN.
>>CAN YOU HEAR ME?
>> WE CAN.
>> IT IS WORKING NOW.
>>YEAH. WE ARE LOOKING OR
CONNECTING THINGS FOR EXAMPLE WE
ARE STARTING TO ADDRESS A
DIFFICULT TASK LOOKING AT THINGS
THAT HAPPEN AT SAME TIME THAT
SOMEBODY HAS PAIN AND FOR
EXAMPLE CO-OCCURRING CONDITIONS
THAT WE TALK ABOUT OR PROBLEMS
WITH SLEEP OR PROBLEMS
ADDRESSING MORE THAN ONE DOMAIN
THAT ARE OUR TENDENCY IS WANTING
TO CONTROL AND SEPARATE AND
STUDY THINGS ONE AT A TIME THEY
ARE SKIENTIVE KALILY RIG RHO US
AND WE MISS THINGS DOING THAT
AND CHALLENGES DOING INTEGRATIVE
RESEARCH WITHOUT SACRIFICING
RIGOR AND WE ARE GETTING THERE
METHOD LOGICALLY BUT WE HAVE TO
NOT BE AFRAID TO DO THAT.
I'M GLAD TO HEAR ENTHUSIASM
LOOKING AT CO-OCCURRING
CONDITIONS BOTH IN PHYSICAL AND
MENTAL HEALTH DOMAIN THAT IS
VERY ENCOURAGING?
>>YOU HAVE YOUR HAND UP?
>>YEAH. BRINGING UP AGREEING
WITH YOU HAVING HEAL PAIN
ENABLED US TO HAVE MORE
INTEGRATIVE SET OF RESEARCH THAT
CAN HOPEFULLY ADVANCE
DEVELOPMENT OF NEW MEDICATIONS
AND ANALGEEZICS PROVIDING WITH
EVIDENCE-BASED GUIDANCE TREATING
PATIENTS WITH COMPLEX
PRESENTATIONS AND WHAT WAS ONE
THING I WANTED US ALL TO KEEP IN
OUR BRAINS IS BIO RELEASED
RECENTLY LATEST REPORT VIS-À-VIS
LEVEL OF INVESTMENT BY COMPANIES
OF DIFFERENT CONDITIONS AND
CANCER IS ONE WITH HIGH
INVESTMENT. AS YOU KNOW, THEY
DO THIS BASICALLY CONTRAST
BETWEEN WHAT IS MAGNITUDE OF
PROBLEM AND WHAT IS INVESTMENT
AND WHAT IS TRAGIC IS BOTH FOR
ONES WITH LOW INVESTMENT IS IN
TERMS OF VENTURE CAPITALS AND
LOWEST LOWEST ARE PAIN AND
SUBSTANCE USE DISORDER. THIS IS
BY GIGANTIC IMPACT THEY HAVE I
WAS THINKING ON IT AND FROM
BEGINN
BEGINNING.
PROCESS AND GET A SENSE HEAL
PERSPECTIVE CAN MAXIMIZE IMPACT
THAT IS A POINT I WANTED TO SAY.
WE ARE ACTUALLY NOT ANY BETTER.
NEITHER FOR PAIN IN TERMS OF
INVESTM
INVESTMENTS.
IVEN VESTMENTLE CAPITAL COULD BE
GOOD ONE TO HELP US FIGURE OUT
IF WE CAN COVER THESE REALLY
DESERT OF INVESTMENT IN THE
FIELD.
>>I WILL THROW OUT A COUPLE OF
THINGS THAT AMIR TOLD ME ABOUT
ATTRACTING SBIRS IN PAIN THAT WE
FUNDED. I THINK THAT WE PUT IN
50 MILLION. THEY ACTUALLY RAISE
130 MILLION ON TOP OF OUR 50.
IT IS COMPARED TO CANCER, YOU
KNOW, IT IS A DROP IN THE
BUCKET, I'M SURE.
THE OTHER THING IS THE SAME LINE
AND MY MEMORY IS FUZZY AND I
THINK THAT WE HAVE PLANS TO DO A
SHOWCASE WITH THE INDUSTRY AND
BIOTECHS WE ARE FUNDING AND
INVESTIGATORS WE ARE FUNDING AND
BRINGING BIG PHARMAPEOPLE IN TO
BASICALLY KEEP THAT FLOW OF
INFORMATION GOING.
WE TALKED OR WE TALKED A BUNCH
OF BIG PHARMA PEOPLE AND THEY
SAID THEY ARE NOT GOING NEAR
PAIN AND ARE INTERESTED TO HEAR
WHAT WAS OUT THERE.
WE HAVE TO MAKE IT TANTALIZING
TO PICK IT UP AND MONEY TO BE
MADE NO QUESTION ABOUT THAT AND
DERISKING PROCESS OF APPROVAL
THAT WE ARE UP TO.
ANYTHING ELSE ABOUT THE SHOWCASE
THAT I CAN'T REMEMBER THE
DETAILS OFF THE BAH THE.
>>I WANT TO SAY IT IS BEING
PLANNED FOR FALL OF THIS YEAR.
>>OKAY.
>>IDEAS IF I HAD ONE TAKEAWAY
FROM THE DISCUSSIONS WE HAD WITH
PRIVATE SECTOR FOLKS THERE IS
CONSOLIDATION WITH NEUROSCIENCE
BASED GENERALLY AND NOT
NECESSARILY PAIN IS UNIQUELY
TARGETED BUT ARE LIMITING
INVESTMENTS ACROSS THE BOARD.
THAT IS ALSO AT SAME TIME NOT
SPECIFIC TO NEURO SCIESCIENCE
INVESTMENT FOR BIOTECH IS
GETTING HARDER AND PICKING UP
PRODUCTS COMMERCIALIZING THEM
RIGHT AWAY AND OTHER HAND WHAT
WE INVESTED IN HEAL BECOMES ALL
THE MORE IMPORTANT.
WE DON'T HAVE AS MANY
ALTERNATIVE OPTIONS FOR SMALL
COMPANIES AND BEING ABLE TO
DISPLAY WORK GOING ON AND
PROGRESS WE ARE MAKING MAKING
KNOWN TO COMPANIES NOT READY TO
INVEST AND ARE IN WATCHFUL
WAITING CATEGORY FITS WITH
CURRENT CLIMATE AND IS PLAN FOR
FALL MEETING.
>>I THINK IT IS VERY GOOD AND
CERTAINLY PROBABLY YOU HAVE
THOUGHT OF THIS AND WE HAVE TO
BRING ALSO DEVICES THAT IS A
COMPLETELY OTHER SPACE THAT
OFFERS FOR OPPORTUNITIES FOR
TREATMENT AND DEVELOPMENT MIGHT
BE FASTER TO BRINGING IN
MEDICA
MEDICATION.
WE HAVE DEVICE PROGRAM AS WELL.
>>IN TERMS OF BRINGING.
>>COMPANY, YES, YES, WHY HE.
>>COMPANIES AND INVESTORS AND
TRYING TO GET AND LISTEN TO THEM
AND THEY WOULD MAKE A DIFFERENCE
AND DON'T THINK BIG PHARMAFOR.
THIS IS SPACE TO MAXIMIZE
INTERACTIONS WITH.
>>RIGHT.
>>NORA AND WALTER THIS IS THE
POINT OF THE CONFERENCE WE ARE
ORGANIZING BETWEEN SBIR GRANTS
OR GRANTEES AND OTHER MEMBERS OF
HEAL ACROSS NIH DOING
THERAPEUTIC DEVELOPMENT PAIN
GETTING NOT JUST BIG PHARMABUT
INVESTORS IN -- WHAT HAPPENS IN
DEVELOPMENT ANGEL INVESTMENT AND
VC AND RIGHT NOW I WAS AT
BIOCONFERENCE WHERE PAPER WAS
PRESENTED AND AUTHOR MADE IT
VERY, VERY CLEAR AND EMILY AND
MYSELF MET WITHES DO JENS OF
COMPANIES SAYING THEY WANT PHASE
2 DATA WHERE GC2 WANTS TO JUMP
IN AND SEE EFFICACY IN PATIENT
POPULATION NOT JUST
THEORETICALLY DOES IT WORK AND
IN ANIMAL MODEL, ET CETERA.
THIS WE HAVE TO FOCUS ON IN HEAL
AND NOT JUST HELP ACADEMICS BUT
ALSO COMPANIES THEMSELVES GET TO
THAT STATE WHERE THEY CAN GET
EARLY PHASE 2. THAT IS THE
FIRST EFFICACY STUDIES.
>>I KNOW. I'M GLAD TO HEAR
THIS. I WOULD BE REMISED IF I
DON'T BRING ANOTHER POINT TO THE
TABLE.
WE DON'T GET THE LUXURY OF
HAVING ALL OF YOU AND GETTING
INPUT IS OPPORTUNITY THAT WE
HAVE WITH ACTUALLY PARTNERING
WITH ARPAH. THAT WILL BE
BRINGING NOT JUST NEW FONTS BUT
A COMPLETELY DIFFERENT STRUCTURE
THAT CAN FACILITATE ADVANCING
DEVELOPMENT OF ACTUALLY
MEDICATIONS AND PRODUCTS.
I THINK THAT IT MAY BE
WORTHWHILE AND THINKING IN THE
MORNING THAT WE HAVE RENÉ WHO
DIRECTS THE ARPA H PROGRAM TO
GIVE A PRESENTATION AT ONE OF
OUR HEAL MEETINGS.
>>GREAT SUGGESTION, NORA. SHE
GAVE A GREAT PRESENTATION THIS
MORNING.
WOULD BE GREAT TO BRING HER TO
THIS GROUP.
>>ALLAN?
>>>>YEAH. TWO THINGS
IMPRESSIVE PRESENTATION AND ONE
SUGGESTION AND COMMENT THIS
DOESN'T INCLUDE ALL OF THE
PROGRESS MADE THROUGH MORE
TRADITIONAL FUNDING MECHANISMS
AND ANY WAY TO INTEGRATE DATA
AND BEEN A SHAME PROGRESS MADE
THROUGH MECHANISMS AND NICE TO
SEE HOW THEY RELATE OR OVERLAP
OR MAYBE DISAGREE AND WE
CERTAINLY DON'T WANT TO BE
REDUNDANT AND KNOW THERE HAS
BEEN DATA GENERATED IN NORMAL
MECHANISMS AND THROUGH MANY
INSTITUTES IS NO. 1 ANOTHER IS
COMMENT ABOUT DEVICES ISSUE AND
TURNS OUT ISP IS 50 YENL
ANNIVERSARY AND I HAVE BEEN
INVOLVED IN THIS AND I'M WRITING
REVIEWS. SHORT REVIEWS ON
PROGRESS AND HIGHLIGHTS, BLAH,
BLAH, BLAH.
ONE OF WHICH IS WORKING WITH FOR
EXAMPLE TROLLS YEN SEN IN
DENMARK WRITING ON CLINICAL
PROCESS AND DRAFTED PIECE AND
INTERESTING AND YOU DIDN'T
INCLUDE ANYTHING ON DEVICES.
HE SAID BECAUSE DATA IS NOT
CONVINCING AND ONE REASON HE
SAYS IS THERE IS RARELY BLIND
TRIALS AND THEY ARE VERY
DIFFICULT TO DO AND NOT PLACEBO
CONTROLLED TRIALS AND HE HAS
WRITTEN WITH OTHERS SYSTEMATIC
TYPES OF REVIEWS ON THINGS AND
IS NOT CONVINCED AND WE HAVE TO
TAKE THAT CONCERN SERIOUSLY WHEN
WE ARE TALKING ABOUT THE DEVICES
THERE WILL BE ACTUALLY A PROPER
RANDOMIZED CONTROL TRIAL TO THE
EXTENT IT IS POSSIBLE BECAUSE
SOMEONE SAYS IT WORKS DOESN'T
MEAN IT WILL WORK. WE KNOW
THAT.
>>GOOD POINT. I THINK THAT
ANYTHING CONFUSED AND IN BRAIN
WE HAVE BUCKLED DOWN ON TRYING
TO UNDERSTAND WHAT IS GOING ON
IN THE CIRCUITS WITH ELECTRICAL
STIMULATION PRIMARILY.
AND THERE IS A -- THERE IS A --
WELL, THERE IS A COUPLE OF
REALLY AMAZING THINGS THAT CAME
OUT IN THE LAST MONTH OR 2 AND
SOMETHING NEXT WEEK AND
SOMETHING ABOUT A MONTH AGO AND
SPINAL CORD INJURY AND NO THE IN
THE PAINT SPACE BUT MOTOR SYSTEM
THAT YOU CAN REALLY MANIPULATE
SPINAL CIRCUITS AND REALLY IN A
UNIQUE WAY. SO, I AGREE THAT --
THAT THE MOVEMENT INTO THE
CIRCUIT MANIPULATION IS GOING TO
BE BIG BUSINESS DOWN THE ROAD
AND MORE PRECISE THAN DRUGS, I
THINK. BRAIN ISSUE IS WHERE ALL
THAT IS SEATING UP.
>>THANK YOU.
>>YEAH. ROB?
>>I HAVE A FEW THINGS, I GUESS.
LOTS OF THIS DISCUSSION GETTING
TO THE POINT OF IT.
JUST MENTIONING WHAT IS GOING ON
IN PAIN RESEARCH SPACE.
WE HAVE A LITTLE OF A PR ISSUE I
THI
THINK.
I HEAR FRUSTRATION FROM PAIN
RESEARCHERS THAT THERE ARE TYPES
OF THINGS THAT THERE IS HEAL
FUNDING DOESN'T FIT WITH KIND OF
YOU KNOW.
>>RIGHT.
>>TYPICAL DISCOVERY TYPE OF
RESEARCH AND SENSE IS THEY ARE
MISSING OUT ONL THIS OPPORTUNITY
AND CONVEYING THERE IS OTHER
MECHANISMS AVAILABLE.
IS THERE -- WE HAVE A SENSE
ABOUT ONGOING INVESTMENT FROM
INSTITUTES IN PAIN RESEARCH HAS
IT CHANGED WITH HEAL? HAS IT
GONE DOWN IN CONTEXT OF NORMAL
R01 TYPE OF MECHANISMS?
>>FOR US IT HAS GONE UP.
>>I THINK THERE IS A MISSING --
>>ANALYSIS SHARED WITH THIS
GROUP A WHILE AGO HOW IT WAS
GOING UP WITH DIFFERENT VIEWS
MACHINE LEARNING APPROACH TO DO
ANALYSIS AND WE COULD SHARE
SLIDES.
>>WE HAVE FANTASTIC PAIN
RESEARCH IN OUR INSTITUTE I
KNOW.
>>YEAH. THIS IS A -- ALMOST A
MARKETING THING I THINK HEAL
COULD BE DOING IN CONTEXT OF BIG
CONFERENCES TO HIGHLIGHT AND
THERE IS LOTS OF THIS GOING ON
MAKING PROGRESS AND IS ONGOING
INVESTMENT THAT HASN'T CHANGE
THE AND THERE IS A SENSE PEOPLE
ARE MISSING OUT ON OPPORTUNITY
AND WE ARE KIND OF MESSAGE IT IS
RAISING BOATS AND ADVANCING MAIN
GOALS TOWARDS CLINIC WE COULD DO
BETTER WITH THAT.
>>WHAT ABOUT IDEA THAT CROSSED
MY MIND BEFORE ABOUT IS IT TOO
CRAZY TO THINK WE CAN BRING ALL
PAIN DATE FRAU NIH INTO A DATA
BASE THAT WOULD KIND OF SIVENGS
WITH WHAT HEAL DATA ECOSYSTEM
DOES?
IS THAT -- WELL, FIRST QUESTION
IS WOULD IT BE VALID AND WOULD
ANYBODY CARE?
>>I THIS I THAT WOULD BE A LOT
OF WORK THAT WOULD BE HARD FOR
PEOPLE TO -- IT WOULD MAYBE NOT
GET AS MUCH UPTAKE. YOU KNOW?
IT IS VALUABLE TO UNDERSTAND
THAT THE QUESTION IS HOW WE
COMMUNICATE IT.
>>YOU HAVE TO SHARE DATA
ANALYSIS THAT WILL BE POSTED
SOMEWHERE.
>>YEAH.
>>AS YOU KNOW, YOU WOULDN'T BE
ABLE TO FIND IT. YOU CAN BUILD
SOMETHING WITH STUFF THAT IS
[INDISCERNIBLE].
>>YEAH.
>>>>JUST AN IDEA THAT IS
INTERESTING THAT CAME UP WITH
DATA.
>>WALTER I DON'T THINK JESS IS
ON TODAY. PART OF DEVELOPING
HEAL DATA ECOSYSTEM WE HAVE
IDENTIFIED REPOSITORIES THAT ARE
COMPATIBLE WITH DATA PLATFORM TO
MAKE HEAL DATA FAIR, FINE
ACCESSIBLE INTEROPERABLE AND
REUSABLE AND RESOURCES WILL BE
MADE AVAILABLE TO EVERY
INVESTIGATOR; RIGHT?
DOESN'T HAVE TO BE HEAL DATA TO
ENTER THEM INTO REPOSITORIES
TAKING ADVANTAGE OF SAME
METADATA INDEXING AND THINGS TO
BE ACING CRESSIBLE. IT THAT MAY
BE A SOURCE OF CONNECTION FOR
BASIC AND OTHER NONHEAL
RESEARCHERS IN HEAL AND IS
FORWARD-LOOKING AT THIS POINT.
MY GUESS IS MOST TYPES OF
INVESTIGATORS ROB IS REFERENCING
HAVE NOT BEEN MAKING FINDINGS
PUBLICLY AVAILABLE IN SAME WAY
GOING FORWARD.
>>YEAH. ANOTHER THING I WOULD
LIKE TO ONE THING I WAS
INTERESTED TO HEAR TODAY WAS
PROPOSALS IN SUBSTITUTE SPACE
ABOUT UPTAKE AND IMPLEMENTATION
WHERE BARRIERS AND I FEEL IT
GETS TO PART OF THE PROBLEM WE
HAVE WITH BIG PHARMA AND PAIN
MANAGEMENT IN VERY BEGINNING
EARLY MEETING WE HAD WALTER YOU
AND NORA WERE BOTH THERE IN THE
MEETING TRYING TO PARTNER WITH
BIG PHARMA.
ONE THING I RAISED ALET THAT
MEETING HAD TO DO WITH SAFETY
BAR.
FEEDBACK FROM REGULATORS IS A
HUGE POPULATION SHARING COMPLETE
SAFETY.
FDA IS IN CHARGE OF SAFETY.
WHAT WE ARE PRESCRIBING NOW
LARGELY CAN DO IMMENSE HARM AND
WOULDN'T BE APPROVED AND POINT
OF WORKING WITH REGULATORS ON
SAFER THAN OPIOIDS AND ANYTHING
SAFER THAN OPIOIDS WOULD BE A
WIN FOR PAIN MANAGEMENT.
>>YEAH.
>>WHAT CAN WE DO AS FAR AS FDA
PROCESS AND TALKING ABOUT
ENDPOINTS FOR CLINICAL TRIALS
TODAY IS ANOTHER POINT. WHAT DO
WE HAVE IN PAIN AND ASKING
PEOPLE ON SCALE OF 0-10 AND
THERE IS WORK BEING DONE THERE
AND WE HAVE DONE AN AMAZING JOB
OF PIPELINE OF OPPORTUNITY TO
HELP GO FROM IDEA TO MOLECULE TO
[INDISCERNIBLE] AND RUN INTO A
BRICK WALL GETTING THROUGH
APPROVAL PROCESS AND THINK YOU
ARE -- I'M REALLY INSPIRED BY
STUFF WE TALKED ABOUT TODAY
RELATED TO SUBSTANCE USE
DISORDER AND HEAL COULD BRING
SIMILAR FOCUS TO PAIN SPACE
HELPING GET THING AS CROSS THE
FINISH LINE WILL BE VERY
IMPORTANT. THAT IS A
COMPLICATED TASK. SAFETY ISSUE
IS VERY COMPLICATED.
THAT PERCEPTION THERE IS FAILED
TRIALS AND THAT STUFF. WE ARE
DEALING WITH THOSE THINGS AND
HAVE DONE A GOOD JOB DEVELOPING
SCIENCE FOR THAT.
WHAT CAN WE DO ON OTHER END TO
FACILITATE THAT WOULD BE USEFUL
AND ENCOURAGING TO KEEP THIS
WHOLE DEVELOPMENT PIPELINE
OPERATING. YOU HAVE DONE THAT.
I THINK IT IS CHANGE RING AND I
HAVE DONE IT IN THE COMMUNITY
AND CHANGED HOW PEOPLE THINK
ABOUT WHAT THEY WILL DO WITH
PAIN RESEARCH AND THERE IS A
PROGRAM AVAILABLE THAT IS THERE.
AND JUST IT LOWERS THE BAR
SIGNIFICANTLY AND HEAL HAS DONE
A FANTASTIC JOB IN TERMS OF
GENERAL FEEDBACK.
A LOT OF NEW THINGS WE ARE
TALKING TODAY ARE REALLY
IMPACTFUL AND PRACTICAL THINGS
THAT NEED TO BE DONE AND ARE IN
THE RIGHT SPOT NOW.
WE HAVE TO BE SMART WITH HOW WE
DEPLOY NEW PROGRAMS SO WE ARE
NOT ROBBING FROM THINGS THAT ARE
-- THAT WE DEVELOPED SO FAR.
I TALKED TOO LONG.
>>IT IS ALL GOOD. HELEN WAS
NEXT.
>>QUICK QUESTION FOLLOWING
DISCUSSION ABOUT GETTING A
BIGGER VIEW WHAT IS GOING ON IN
PAIN RESEARCH INSIDE AND OUTSIDE
OF HEAL. THIS IS A TOPIC COMING
UP AT LAST IPRCC MEETING INTD
AGENCY PAIN COMMUNITY AND
PRESENTATION ABOUT WHAT HEAL IS
DOING AND COMMITTEE MEMBERS WERE
TALKING ABOUT WHILE THERE IS
PAIN RESEARCH GOING ON IN PLACES
LIKE VA FOR EXAMPLE AND COREY
AND PLACES TO BE NICE TO HAVE
OVERVIEW OF THAT TO SEE HOW IS
ALL THAT HELPING EACH OTHER AND
MAKING SURE WE ARE NOT
DUPLICATING THINGS AND HOW WE
SIN ERNLIZE.
THERE WILL BE A SUBGROUP OF IPCC
AND LOOKING AT THAT AND DIDN'T
TALK ABOUT WHAT IS IS GOING ON
WITH NIH OUTSIDE OF HA ELTHAT IS
INTERESTING AND NOT TALKING
ABOUT GOING DRILLING DOWN TO
LEVEL OF DATA THAT IS ANOTHER
THING WE CAN DO. LOOKING AT
LEVEL OF PROJECTS AND GROUPS OF
PROJECTS MIGHT BE REALLY
INTERESTING TO DO IN CONJUNCTION
WITH EFFORT TO GO ACROSS
AGENC
AGENCIES.
YEAH. GOOD POINT.
WE HAVE RCDC TO WORK OFF OF.
>>PORTFOLIO ANALYSIS HELPED US
IF YOU RECALL WALTER WHEN
WANTING TO COMPARE HISTORICALLY
NIH INVESTMENT PAIN RESEARCH AND
HOW HEAL HAD EXPANDED ABOUT YOU
IN A NONDIAL LUTED WAY
INCREASING OVERINVESTMENT THAT
THEY WERE VERY HELPFUL AND ALSO
WITH VISUALIZATIONS.
>>YEAH. GREAT.
>>YOU CAN DO THAT AGAIN.
>>NORA?
>>YEAH. MAKING SAME POINT TO
SELENA IT WILL BE VERY, VERY
VALUABLE AND VALUABLE TOO
BECAUSE DIALOGUES WE ASK
OURSELVES IS HOW WE DISTINGUISH
WHEN IT SHOULD BE HEAL PAIN
PROJECT VERSUS A PAIN PROJECT BY
INSTITUTES AND HAVING
UNDERSTANDING OF THAT LANDSCAPE
WILL GIVE PERSPECTIVE OF CERTAIN
THINGS THAT ARE MORE TARGETED TO
AREAS THAT ARE UNIQUE TO WHAT
THEY ARE DOG OR MAYBE NOT OR
INCORPORATED INTO MORE
COORDINATED RESEARCH AGENDA AND
I THINK IT IS NO-BRAINER LOOKING
AT HOW LANDSCAPE WORKS IN TYPES
OF PROJECTS AND HUGE RESEARCH ON
NEUROSCIENCE OF PAIN OF COURSE.
>>RIGHT.
>>AND FARM COL.
>>YEAH.
>>INTERESTING TO KNOW, NORA.
DOING THAT LARGE LOOK ACROSS
AGENCIES IS THERE ANYONE
TACKLING DISSEMINATION
CHALLENGES BROUGHT INTO HEAL AND
WE HEARD EXCITING THINGS THIS
MORNING ABOUT OPIOID SPACE ABOUT
THINGS TO DO DOING TRANSLATIONAL
WORK IN ATTACKING AND WORKING
WITH AND TRYING TO BREAK DOWN
HOSPITAL SYSTEMS ISSUES.
ANY OTHER POCKETS WHERE PAIN
RESEARCH IS GOING ON ACROSS
AGENCIES IS THERE IS GREAT DNI
WORK GOING ON COULD BE BROUGHT
INTO HEAL COULD BE GREAT AND
WONDERFUL TO KNOW.
>>I AGREE 100%.
>>THIS IS GREAT INPUT.
>>WE ARE HAVING A HIGH-LEVEL
DISCUSSION AND WOULD INVITE THE
MULTI-DISCIPLINARY WORKING GROUP
MEMBERS TO REACT TO THE
INFORMATION THAT IS ON THE SLIDE
OR WE CAN MOVE FORWARD TO THE
DISCUSSION QUESTIONS AND JUST
FROM YOUR PERSPECTIVE WHAT AT
THIS INFLECTION POINT FOR HEAL
IS IMPORTANT TO BE SURE WE
CONTINUE TO FUND OR ADD TO THE
PORTFOLIO?
YOU ARE IN THE BEST POSITION TO
ADVISE US ON THIS. SO, VERY
OPEN TO INPUT.
>>I THINK I COVERED THAT
QUESTION WITH WHAT I WOULD SAY.
>>YEAH.
>>[INDISCERNIBLE].
>> IN TERMS OF IDEA ABOUT WHAT
HEAL IS DOING THAT IS SORT OF
DIFFERENT THAN WHAT IS HAPPENING
WITH ICS AND WAY TO LOOK AT WHAT
WE HAVE DONE WITH AT LEAST ON
PAIN ASPECTS OF HEAL IS TO BUILD
THIS ENABLING ECOSYSTEM THAT
ALLOWS PEOPLE TO REALLY PROGRESS
THEIR IDEAS FROM DISCOVERY TO
THERAPEUTIC.
AND THAT IS WHERE WE CAN HIGH
LIGHT WHAT FOR THAT COMMUNITY IN
TERMS OF MARKETING ASPECT IS
WHAT WE ARE TRYING TO DO HERE IS
GET THINGS FROM ACROSS THAT
LINE.
NOT EVERYTHING FITS IN THE
BUC
BUCKET.
>>ENABLE INFRASTRUCTURE AND
ECOSYSTEM IS ONE AS I SAID IS
CHANGING THINGS ENCOURAGE YOU TO
CONTINUE.
>> PSPP IS AN EXPERIMENT.
WE ARE DOING ANIMAL MODELS THAT
WILL BRING A LEVEL OF RIGOR TO A
FEW ASSETS THAT COME THROUGH.
MAKING SURE WE GET TO SEE
OUTCOMES OF THOSE AND WHAT
HAPPENS WITH CLINICAL TRIALS IS
A LOT TO BE LEARNED THERE THAT
CAN ABSOLUTELY CHANGE THEIR WAY
TO VALIDATE HOW WE ARE DOING
THINGS AND IS VERY IMPORTANT AND
TRAINING ASPECTS WHAT WE ARE
DOING HERE.
WALTER YOU HIT IT ON THE HEAD
LACK OF PAIN INSTITUTE MEANS
TRAINING OPPORTUNITIES ARE RARE
RELATIVE TO RESEARCH AREAS AND
HEAL GETTING INTO THAT SPACE IS
REALLY IMPORTANT.
NEW AREAS OF RESEARCH THAT I
THINK I -- THERE IS A LOT COMING
IN TERMS OF DISCOVERY SCIENCE
WITH NEW TECHNOLOGY THAT IS IN
OMICS SPACE THAT WILL CHANGE ON
THE DISCOVERY SIDE FOR SURE AND
WE SHOULD BE ABLE TO TAKE
ADVANTAGE OF THAT.
THINGS IT THAT WE OR I MENTIONED
ON WORKING ON BACKEND ON
TRANSLATION TO PRACTICE AND
APPROVAL ON THE PAYER SIDE
GETTING THINGS POORLY COVERED
ARE OPPORTUNITIES FOR REAL RAPID
IMPACT WITH PAYERS IF YOU CAN DO
THINGS THAT CAN INFLUENCE WAY
THINGS GET OR INFLUENCE UPTAKE
IN TERMS OF GETTING BILLING
CODES FOR TREATMENTS THAT APPLY
PAIN WOULD BE HELPFUL AND ARE
PRAGMATIC THINGS WE COULD DO
THAT MIGHT HELP TO GET THINGS
MORE QUICKLY TO PATIENTS THAN IT
TAKES WITH DEVELOP MEMENT.
IT WILL HELP ON BACKEND.
>>RIGHT.
>>THANK YOU.
>>WE DON'T HAVE TIME RIGHT NOW
BUT ONE OF THE FUTURE MEETINGS
ALONG WITH SUGGESTIONS MADE THAT
WE SHOULD HAVE LINDA PORTER
SPOKE TO US YESTERDAY WITH --
MAIN MANAGEMENT BILLING CODE
WITH DATA MEASURES FOR PAIN THAT
WERE DEVELOPED BY HEAL TEAM.
THERE IS A LOT TO SHARE IN THAT
REGARD AND LO ITS TO DO.
SHARON?
>>FOLLOW UP WITH WHAT ROB SAID
AND REAL OPPORTUNITY TO
INCENTIVIZE MODELS OF CARE AND
HAVING WE HEARD THIS MORNING EMS
TEAM IS DWIFING BU PREN OR FRIN
NOW AND FOUR YEARS AGO WOULDN'T
HAVE THOUGHT OF THAT AND
CHANGING PRACTICE ACT AND ALL
THINGS GAIL SPOKE ABOUT AND
THINKING OF WAYS TO DEPLOY
WORKFORCE WE DO HAVE TO BETTER
SERVE PATIENTS IS A REAL
OPPORTUNITY TO LEVERAGE
RESOURCES AND IMPROVE CARE AND
DECREASED COSTS FOR PATIENTS AND
WOULD LOVE TO SEE AGAIN IF THERE
IS OTHER SPACES IN THE LARGER
PORTFOLIO WHERE THAT IS GOING
ON, BRINGING THAT INFORMATION TO
THE HEAL SPACE WOULD BE VERY
HELPFUL.
ANYTHING THAT WE CAN DO TO
ACCELERATE ADVANCES IN GETTING
CARE TO PATIENTS WOULD BE
FABULOUS.
>>>>RUNNING PRISON NETWORK
THAT IS HEALTH SYSTEMS AND WE
HAVE THIS IDEA OF TRYING TO
RESEARCH INTEGRATED PAIN CARE
MODELS AND HEALTH CARE SYSTEMS
THAT I THINK OUR ISSUE HAS BEEN
ATTRACTING HEALTH CARE SYSTEMS
INTO THE SPACE OPPOSED TO
ACADEMIC PEOPLE WHO CAN PUBLISH
AND SEE WHAT HAPPENS.
>>IF YOU CAN SHOW DECREASED
COST IN EMERGENCY DEPARTMENT
VISITS WILL GET ATTENTION RIGHT
AWAY.
BAR IS LOW IN SENSE WHAT GETS
ATTENTION. IT IS ALL ABOUT
COST.
>>YEAH.
>>DECREASING NUMBER OF STAYS
AND NUMBER OF VISITS AND LENGTH
OF STAY AND NUMBER OF VISITS.
>>RIGHT. PROBABLY LOTS OF WAYS
TO DO THAT IN PAIN SPACE .
WE WILL TALK TO HEALTH CARE
SYSTEMS TRYING TO GET THAT OFF.
>>PUTTING PHYSICAL THERAPISTS
IN EMERGENCY DEPARTMENTS AND
PATIENTS COMING IN WITH FLAIR UP
AND ACUTE LOW BACK PAIN AND
CHANGING TRAJECTORY OF PATIENT
ACROSS EPISODE OF CARE AND EARLY
DATA VERY PRELIMINARY DATA SHOWS
INCREASED FUNCTION AND DECREASED
PAIN AND COST SAVINGS AND LARGE
DATA SETS AGGREGATING COULD
REVEAL OPPORTUNITIES TO CHANGE.
>>LISTENING TO THIS GETTING
SPECIALTIES INVOLVED AND STRUCK
BY COMMENT YESTERDAY ORNLO
PEEDIST STUDY BONE PSYCHIATRISTS
UPHILL BY AND LARGE AND PAIN
DON'T DEAL WITH IT AND WORKFORCE
DEVELOPMENT GETTING SPECIALTIES
TO SEE IS PART OF MISSION.
>>THIS IS COMMON AND
OVENGOLOGISTS DON'T TREAT PAIN
AND THEY HAVE A LARGE TEAM
AROUND THEM TAPPING INTO AND
GETTING ORNLO PEEDISTS AND
PRACTITIONERS TO ADOPT THAT
MODEL THAT IS AN
INTERDISCIPLINARY TEAM NOT JUST
INTERDISCIPLINARY TEAM SITTING
DOWN TALKING TO PATIENTS AND
PROFESSIONS BRING EXPERTISE TO
THE TABLE.
>>YEAH?
>>I'M INTERESTED IN THE
DISCUSSION. GOING FURTHER AND
FURTHER AND DEEPER AND DEEPER
INTO IMPLEMENTATION SCIENCE
WORLD WE ARE STARTING TO THINK
ABOUT QUESTIONS WE WOULDN'T HAVE
WANTED TO THINK ABOUT MAYBE 4 OR
5 YEARS AGO; RIGHT?
EARLY STUDY WAS -- DIDN'T GET
FUNDED BY PRISM WHERE IT WAS
PROPOSING TO LOOK AT DIFFERENT
CARE MODELS AND ONE TYPE OF
PRACTITIONER WAS GOING TO SEE
THE PATIENT FIRST OPPOSED TO
SECOND AND WE FUNDED IT AT
NCCIH.
THIS IS SOMETHING LIKE JUST FOUR
YEARS AGO WE DIDN'T WANT TO GO
THERE.
NOW, I THINK WE ARE LOOKING
ATHAT THE FRONT AND CENTER
LOOKING AT CARE MODELS.
IT IS INTERESTING TO SEE HOW
CONVERSATION HAS EVOLVED ABOUT
-- BECAUSE AS SHARON MENTIONED
PHYSICAL THERAPIST INSIDE
DEPARTMENT -- THERE IS HOSPITAL
AND IS IT OUR BUSINESS TO TELL
THEM THAT?
NO. OF COURSE. WE CAN DESIGN A
PRAGMATIC IMPLEMENTATION TRIAL
IN A HOSPITAL SETTING LOOKING
LIKE DIFFERENCE BETWEEN
EMERGENCY DEPARTMENT WITH
PHYSICAL THERAPIST AND ONE
WITHOUT AND QUESTIONS TO GRAPPLE
WITH AND I THINK IS GREAT AND
LIKE THAT SUGGESTION, SHARON.
>>THANK YOU TO YOUR INPUT AND
STUGSS AND WE CAN BEGIN TO MOVE
TO THE NEXT SECTION OF THE
SUMMARY THAT WILL BE BRIEF.
NEXT SLIDE, PLEASE. YOU HAVE
SEEN BEFORE ALL OF THE DIFFERENT
HEAL PROGRAMS LAUNCHED ON
TRANSLATING OPENOID USE DISORDER
STARTING WITH LARGE AND
AMBITIOUS IMPLEMENTATION SCIENCE
AND COLLABORATIVE STRUCTURES
THAN ADDING SPECIFIC AREAS OF
FOCUS THAT ARE INCLUDING
RESEARCH RECOVERY SUPPORT
SERVICES AND HARM REDUCTION AND
POLY SUBSTANCE USE AND TOPICS
DISCUSSED AT BOTTOM HERE AND
GOING TO NEXT SLIDE, PLEASE.
>>ON THE PREVENTION AND
TREATMENT OF OPIOID USE
DISORDERS WE HAVE A DIFFERENT
SIDE INVESTMENTS WITH SIMILAR
TRAJECTORY STARTING WITH
RESEARCH AT RISK GROUPS AND
TRIALS IN NIDA CLINICAL TRIALS
NETWORK ADDING ON SPECIFIC
STUDIES FOCUSING ON SPECIFIC
POPULATIONS AND ALSO EXPANDING
INTO SOCIAL DETERMINANTS OF
HEALTH RECOGNIZING HOW IMPORTANT
IT WILL BE ULTIMATELY FOR
PREVENTION AND ADDING TRIALS WE
TALKED ABOUT TODAY AS POTENTIAL
ADDITIONS TO OVERALL PORT FOLIO.
NEXT SLIDE, PLEASE.
>>YOU HEARD FROM KENT NER ABOUT
PROGRESS BEING MADE AND
INDIVIDUAL STUDIES AND
INDIVIDUAL INDS THROUGH THESE
PROGRAM AND ALSO SOME ADDITIONS
RELATED TO SPECIFIC TYPES OF
SUBSTANCE USE DISORDER INCLUDING
STIMULANTS AND SPECIFIC
APPROACHES FOR TREATING THESE
AND ENDING WITH CLINICAL OUTCOME
ASSESSMENTS WE JUST DISCUSSED.
NEXT SLIDE, PLEASE.
WE DIDN'T TALK AT ALL ABOUT
BABIES TODAY.
WE HAVE RESEARCH UNDERWAY
ALREADY FOCUSED ON INTERVENTIONS
AND EXPOSURE DURING MOTHER'S
PREGNANCY SCREENING APPROACHES
AND LONG-TERM ASSESSMENTS
FOLLOWING BIRTH OF FAMILY AND
UNDERSTANDING THOSE EXPOSURES IN
CONTEXT OF ALL OTHER EXPOSURES
THAT A CHILD HAS AND WE HAVE
ADDED TO THAT WITH KIND OF WAYS
TO MAKE SURE RESEARCH IS STRONG
UNDERSTANDING PLACENTA AND
UNDERSTANDING ADDITIONAL ASPECTS
OF BIOL THROUGH BIOSPECIMEN
COLLECTION AND BEING ABLE TO
CONTINUE TO SUPPORT FAMILIES
THROUGH PEER NAVIGATORS AND
PROMOTE ASSESSMENTS AND NOTHING
PROPOSED TO BE ADDED THIS TIME
AROUND AND DON'T HAVE LOTS TO
DISCUSS THERE IN TERMS OF NEW
ADDITIONS.
GOING TO NEXT SLIDE I WILL TURN
IT OVER TO NORA.
WE HAVE A QUICK SUMMARY WHAT WAS
DISCUSSED TODAY.
AND WHAT WAS DISCUSSED LAST WEEK
IN TERMS OF PROGRAMS THAT ARE IN
A SPOT FOR CONTINUATION OR
DISCONTINUATION AND NEW RESEARCH
COMES UP PROPOSED TO EYE TO THE
PORTFOLIO AND THINK NEXT SLIDE
SHOULD BE DISCUSSION QUESTIONS;
RIGHT?
>>YEAH.
>>THANK YOU.
>>THANK YOU, NORA. TAKING IT
AWAY, PLEASE.
>>THANK YOU TO ALL MEMBERS OF
MULTI-DISCIPLINARY WORKING
GROUP. THERE HAVE BEEN SEVERAL
A** SPEB-- ASPECTS DISCUSSED
THROUGHOUT THE DAY AND LINGERING
PROJECTS IS MY PERSPECTIVE GIVES
A BACKBONE WHERE IT IS AND WHAT
IT IS THAT WE ARE TRYING TO
ACHIEVE.
FOR OVERDOSE CRISIS WE KNOW WE
HAVE TO EXPAND TREATMENT THAT IS
FUNDAMENTAL AND CRUCIAL AND
EXPANDING TREATMENT IS NOT JUST
EXPANDING MEDICATIONS FOR OPIOID
USE DISORDER ABOUT YOU EXPANDING
ACCESS TO NAL OX YOEN THAT IS
EASIER SAID THAN DONE AND MANY
PROJECTS YOU HAVE SEEN PRESENTED
THAT ARE ONGOING ALREADY IN
DOING CTN AND CLINICAL TRIAL
NETWORK AND ALSO PART OF OTHER
PROJECTS THAT WERE INITIATED
THROUGH J COIN OR HEALTH
PERSISTENCE AND AIM ACTUALLY
MAXIMIZING DIFFERENT MODELS THAT
WE CAN DEVELOP TAKING ADVANTAGE
OF THE FACT THAT AT LEAST FOR
TREATMENTS THAT WE HAVE AN
INFRASTRUCTURE IN OUR COUNTRY
THAT ALLOWS US TO DEPLOY THEM
AND WE CAN EXPAND THEM AND YES
WE HAVE COME FROM VERY MUCH
FOCUSING EFFORTS OF CLINICAL
TRIAL NETWORK AND GOING FROM
SPECIALIZED TREATMENTS GOING
INTO HEALTH CARE.
YOU HAVE SEEN HOW SUCCESSFUL
THAT HAS BEEN WITH RESPECT TO
ENGAGING IN PRIMARY CARE
PHYSICIANS AND PROPOSALS BEING
PRESENTED REGARDING INDIVIDUALS
THAT GO INTO THE HOSPITAL FOR
MEDICAL OR SURGICAL PROCEDURES
THAT IS ANOTHER LOW-HANGING
FRUIT AND ANOTHER AREA THAT WE
HAVE BEEN VERY MUCH DEVELOPING
IS THAT OF INFECTIOUS DISEASE
AND WE ARE VERY INTERESTED
ACTUALLY IN BRINGING FORWARD THE
HEALTH CARE SYSTEM INTO
PEDIATRICS AND IN PEDIATRICS YOU
DO A BETTER JOB DOING SCREENING
AND EARLY IDENTIFICATIONS.
AND SO FOR TREATMENT WE HAVE
HEALTH CARE ON ONE HAND AND
OTHER SYSTEM WE PROBE IS THAT OF
JUSTICE SETTING THAT ENABLES US.
THAT HAS CHANGED DRAMATICALLY I
WOULD SAY OVER THE PAST FIVE
YEARS AND ON THE WILLINGNESS OF
JUSTICE SIFT NEM JAILS AND IN
TRANSITION IN PAIREL.
THERE IS A LOT OF WORK TO DO AND
THINK ONE PROPOSAL YOU SAW IS
THAT TISHA WAS PRESENTING IS HOW
DO WE EXPAND THOSE ADVANCES WE
DON'T IN JUSTICE SETTINGS
BRINGING FORWARD INTERVENTIONS
IF IN JUSTICE SETTING AND FOR
EXAMPLE ARE INITIATIVES COULD
TAKE ADVANTAGE OF POLICE AND
LOCAL EFFORTS GENERATED IN
COMMUNITIES FOR POLICE TO BRING
INTO TREATMENTS AND EXPLORING
FOR THOSE INNOVATIONS THAT
RESULTED US DUE TO URGENCY OF
CRISIS COMMUNITIES ARE DOG TO
BRING IT FORWARD AS A MORE
INTEGRATED PLATFORM THAT ALLOWS
TO WORK NO THE JUST WITH JUSTICE
BUT WITH OTHER ORGANIZATIONS IN
THE COMMUNITY AND THAT IS
HELPING AND WE HAVE FOR
TREATMENT THAT IS MANY MUCH MORE
THAN WE HAVE FOR PREVENTION THAT
IS IN THE SECOND ELEMENT.
SO, A LOT OF WORK IS GOING INTO
PREVENTION AND INTO
IMPLEMENTATION RESEARCH TO
ENSURE THAT HEALTH CARE SYSTEM
CAN PARTICIPATE IN SCREENING AND
IN THERAPEUTICS OF INDIVIDUALS
WITH OPIOID DISORDER AND THROUGH
ADDICTIONS AND AREA THAT
BASICALLY WE ARE DOING
TREMENDOUSLY THAT IS NO THE NEW
AND SOMETHING THAT HAS BEEN WITH
MANY INVESTIGATORS AND MANY
PEOPLE IN PUBLIC HEALTH IS THAT
PREVENTION WE SPEAK A LOT ABOUT
PREVENTION AND WE DON'T HAVE
INFRASTRUCTURE IN THE UNITED
STATES OR IN MANY OTHER
COUNTRIES AND CERTAINLY NOT IN
THE UNITED STATES TO DEPLOY
PREVENTION INTERVENTIONS AND
VERY DIFFERENT FROM HEALTH CARE
WHERE TREATMENT CAN BE
IMPLEMENTED TO HEALTH CARE.
WITH RESPECT TO WAY WE ARE
DEALING WITH OVERDOSE CRISIS
WITH PREVENT IS LOOKING AT WHAT
INFRASTRUCTURE COULD BE BUILT.
VERY IMPORTANTLY HOW WE CAN TAKE
ADVANTAGE OF INFRASTRUCTURE OUT
THERE TO DEPLOY PREVENTION AND
RESPECT FOR EXAMPLE CLINICAL
TRIAL NETWORK THAT LAUNCHED
RANDOMIZED CLINICAL TRIAL FOR
SUBTHRESHOLD INDIVIDUALS WITH
OPIOID USE DISORDER AND
INDIVIDUALS THAT DON'T HAVE
SUBSTANCE USE DISORDER DIAGNOSIS
BUT ARE STARTING WITH RISKY
PATTERNS OF DRUGS HOW TO
INTERVENE AND COULD BE REFERRED
TO US SECONDARY PREVENTION THAT
IS ONE THAT IS EXTREMELY
IMPORTANT AND WOULD SAY IN MANY
WAYS IS AKIN TO WHAT DIABETES
FIELD IN 2000 WHEN CAME UP WITH
CONCEPT SCREENING AND INTERVENE
FOG PREADDICTION AND DIABETICS
AND CAN WE DO SOMETHING SIMILAR
FOR PREADDICTION AND SUBSTANCE
USE DISORDER AND THIS IS ONE
ELEMENT THAT RELATES TO
DISCUSSES GOING ON AND PROJECTS
YOU HAVE SEEN DEPLOYED AND
THROUGH NIDA AND DECADES
INVESTING ENORMOUS AMOUNT OF
MONEY ON PREVENTION RESEARCH AND
PREVENTION THAT WORKS AND IT IS
NOT IMPLEMENTED.
THIS IS AGAIN AN ASPECT THAT WAS
BROUGHT UP BACK AND FORTH. YOU
CAN HAVE SCIENCE IF THERE IS NOT
A BUY IN OR SUSTAINABLE WAY OF
PROVIDING THAT SERVICE IS NOT
GOING TO HAPPEN. SO, IN GENERAL
PREVENTION HAS NOT BEEN A
PRIORITY FOR INVESTMENTS.
TO ME AT LEAST CERTAINLY FROM
PERSPECTIVE OF SCIENCE WHAT CAN
WE DO THAT WILL CHANGE THAT
DIALOGUE?
PREVENTION RESEARCH THAT YOU
HEARD IS ACTUALLY TRYING TO
PROVIDE DATA FOR HEALTH CHANGE
POLICIES THAT BASICALLY LINKING
TO MORE SPECIFIC PROPOSAL OF HOW
DO YOU USE SCIENCE TO GUIDE
POLICIES AND APPLY IT AND
TRANSLATE IT AND AREA OF
PREVENTION IS CRUCIAL. NOT THAT
WE DON'T HAVE EVIDENCE-BASED
PREVENTIONS THAT WORKING BUT
THAT NO ONE IS PAYING FOR THEM
OR SUSTAINING THEM.
WE NEED TO CROSS THAT BRIDGE.
ALSO IN FIELD OF PREVENTION FOR
OPIOID DISEASE THAT WE NOTED
VERY EARLY ON THAT MOST
PREVENTION PORTFOLIO FOCUSES ON
CHILDREN AND ADOLESCENCE AND
[INDISCERNIBLE] IS PERIOD OF
TREMENDOUS STRESS AND TURMOIL
THAT IS CHALLENGING SEEING
OVERDOSE CRISIS PREVENTION
EFFORTS BEING PUT FORWARD ARE
TACKLING THIS ANL GROUP AND
DEMOGRAPHIC THAT ACTUALLY FOR
WHICH EVIDENCE BASED PREVENTION
IS MUCH MORE LIMITED AND
ELEMENTS OF TREATMENT AND
PREVENTION ONE GREAT TERRITORY
TEAM COMES AROUND FOR PAIN SIDE
AND FOR US IS CONCEPT HOW DO WE
COORDINATE EFFORTS? STARLTING
TO SEE HOW MANY RESEARCH
PROPOSALS IN FACT HAVING
ASSOCIATIONS WITH THE OTHER
COORDINATING EFFORTS RESEARCH
DEALING WITH HEALING INSTITUTES
AND ORGANIZATIONS AND BROUGHT UP
MANY TIMES AND SEEM TO REPEAT
MYSELF AND IS CRUCIAL WE LISTEN
AND DON'T FORGET AND BRINGING UP
AGENCIES DEPLOYING THIS THAT IS
HRSA AND CMS FOR MEDICAID AND
SAMHSA. WE HAVE TO WORK WITH
THEM THAT PARTNERSHIP HAS
SUSTAINABILITY AND DEPARTMENT OF
JUSTICE HAVING THEM BUY IN TO
THE VALUE OF SCIENCE AND WHAT IT
MEANS IN TERMS OF PRACTICES I
THINK HAS BEEN DONE SUCCESSFULLY
AS OF NOW AND WITHOUT IT IS
BASICALLY LOT OF WORK WE ARE
DOING WILL END UP AS AN
INTERESTING ARTICLE IN A
JOURNAL. WHEREAS WHAT WE SEE IS
BEING TRANSLATED INTO PRACTICE
IN AREA OF IMPLEMENTATION FOR
TREATMENT AND PREVENTION AND
CLEARLY BECAUSE THAT IS WHY WE
ALWAYS PRIORITIZE IT AND ONE
THING FROM THE BEGINNING WHEN
FRANCIS SAYS WHEN YOU HAVE MORE
MONEY WHAT WOULD YOU DO? NEED
MORE MEDICATIONS AND
THERAPEUTICS FOR SUBSTANCE
DISORDER AND WE ARE LUCKY WHAT
THIS IS AND DO WE STOP WITH CORE
DIFFERENT TYPES OF FARM LOGICAL
ENTITIES?
WE NEED TO PUSH IT FURTHER AND
PUSH IT FURTHER BECAUSE NOT
EVERYBODY SHOULD RESPONSE TO IT.
RELAPSE RATES WE ARE GETTING ARE
PRETTY HIGH AND LOTS OF WORK CAN
BE DONE TO IMPROVE WHOLE ASPECT
OF MEDICATION DEVELOPMENT AND I
ALSO THINK THERE IS, AGAIN, THAT
IS WHY YOU HAVE PROPOSALS FOR
CLINICAL TRIAL NETWORK AND THERE
IS A LOT OF RESEARCH THAT CAN BE
DONE AND HELP US ACTUALLY
IMPROVE THE WAY WE USE THIS
TREATMENT INTERVENTIONS AND THAT
IS WHY I BASICALLY SPOKE UP WHEN
DISCUSSING ISSUE COMBINING BU
PREN OR FRIN AND [INDISCERNIBLE]
THAT IS AN ANTIDEPRESSANT THAT
BASICALLY BASED ON WHAT WE
ALREADY KNOW IT WILL HELP RETAIN
PEOPLE IN TREATMENT FOR A LONGER
TIME PERIOD.
TO EXTENT WE CAN IDENTIFY WHICH
ARE AREAS THAT WE CAN DO
TRACTION RAPIDLY SHOWING THERE
IS A LARGE BENEFIT THERE IS --
THOSE -- THE TYPE OF FINDING CAN
IMPACT CLINICAL PRACTICE THAT IN
TURN CAN HELP US AND ENSURE
THERE IS PROPER REIMBURSEMENT.
AT END OF ALL THESE I MEAN
OBVIOUSLY THIS IS THE SPACE THAT
WE ARE INTERACTING ALL THE TIME
WITH DIFFERENT AGENCY WHAT WE DO
AND NIDA DOES IS NOTION OF
RECOGNIZING THAT KEY ASPECT FOR
ALL OF US TO BE SUCCESSFUL AND
RELEVANT TO PAIN IS TRAINING OF
THE SCIENTISTS THAT WILL
CONTINUE TO DO THIS WORK.
ALSO, TRAINING OF INDIVIDUALS
THAT WILL MAKE POSSIBLE
IMPLEMENTATION OF INITIATIVES.
AND SO THIS WAS NOT SPECIFICALLY
PROPOSED WITHIN THE SPACE BUT
TRAINING WAS ONE KEY PROPOSAL
FOR THE PAIN.
I DO THINK THAT ASPECT IS
CRUCIAL WHERE WE CAN ASK DO
REALLY ADVANCE QUALITY OF THE
EDUCATION MATERIAL THAT IS
PRESENTED TO PEOPLE ENGAGED WITH
PATIENTS WITH PAIN.
ALSO, FACILITATE TYPE OF QUALITY
EDUCATIONAL MATERIALS ENGAGED
WITH INDIVIDUALS [INDISCERNIBLE]
AND SOME OF WHOM HAVE SUBSTANCE
USE DISORDER.
MY LAST POINT I HAVE TO SAY I'M
OBVIOUSLY THINKING ABOUT IT
CONSTANTLY IS THESE ARE SPACES
WE ARE COVERING.
IS THERE ONE OR ANYTHING THERE
THAT BOTHERS ME I WOULD LIKE US
TO HAVE BASICALLY A BETTER HOLD?
YOU HEARD ME SAY IT AGAIN.
I WILL REPEAT IT AGAIN. IT IS
STILL A TREMENDOUS NEED THAT IS
A NEED OF MORE TIMELY DATA.
I THINK WE ARE ALWAYS IN
RESPONSIVE MODE AND DON'T
EXACTLY KNOW WHERE THE SITUATION
IS.
LAST WEEK HAD A MEETING WITH
ONDCP AND WANTED TO DISCUSS RISE
IN SILO KROOEN YOU SAW IN ALL OF
THE NEWSPAPERS AND SILO SEEN IS
STARTING TO EMERGE IN NEWSPAPERS
BECAUSE OF REALLY ADVERSE
CONSEQUENCES IT HAS TO PATIENTS
INJECTING DRUGS WITH SILO SEEN.
ATTENTION IS BROUGHT THIS IS A
PROBLEM AND WE SHOULDN'T BE HERE
WITH TOOLS AND PROCESSES
ENABLING US TO DOCUMENT IN A
MUCH MORE TIMELY MANNER WHAT ARE
DRUGS THAT ARE EMERGING ALLOWING
US TO RESPOND MORE RAPIDLY AND
INFRASTRUCTURE WILL HELP US
DETERMINE EXTENT TO WHICH
INTERVENTIONS HAVE A IMPN IMPAC
IT EQUITABLE AND CERTAIN GROUPS
THAT ARE NEGLECTED? ALL I
WANTED TO SAY AND LOTS OF
DISCUSSION AND WONDERFUL
PRESENTATION AND POINTS BROUGHT
UP TO ALL OF US.
WHILE HERE IN OPEN DIALOGUE I
WOULD WELCOME THAT DIALOGUE TO
CONTINUE WHEN THIS MEETING IS
ADJOURNED AND IF YOU HAVE IDEAS,
PLEASE REACH OUT TO US AND
THANKS FOR PARTICIPATING.
>>SAME HERE. GOOD POINT.
THERE IS A HAND UP.
>>YES.
>>THANK YOU SO MUCH. I
APPRECIATED THAT SUMMARY AND
FACT YOU POINTED OUT SILO SEEN
AND WOULD LIKE TO SHARE THAT IS
THE TIP OF THE ICEBERG; RIGHT?
THERE IS SO MANY DIFFERENT TYPES
OF TOXIC ADULTERANTS IN
SUBSTANCES AND DIFFERENT TYPES
OF FENTANYL IS OUT THERE AND A
PAPER WAS PUBLISHED WHERE
COLLEAGUES SHOWED THAT VERMONT
AND KENTUCKY SAMPLES FROM DEA
HAD UP TO 9 DIFFERENT TYPES OF
SYSTEMS INSIDE THEM NOT JUST
FENTANYL; RIGHT? PUTTING IN
BRAIN HOW HEAL INITIATIVE CAN BE
LEVERAGED TO FIND OUT MORE
QUICKLY WHAT TOXIC
[INDISCERNIBLE] ARE AND WHAT
THEY ARE DOING AND COMBINATIONS
MAKING THINGS MORE LETHAL FOR
PEOPLE USING SUBSTANCES.
>>I AGREE TOTALLY AND BROUGHT
UP ISSUE OF SILO SEEN IN THE
NEWSPAPER AND EVERYBODY REACTS
AND WE HAVE SEEN THIS HAS HAVE
BEEN APPEARING FOR 6 MONTHS IF
NOT LONGER AND IS A TREADMILL.
GAIL?
>>YES. I WAS GOING TO SAY
THANK YOU EVERYONE HERE BRINGING
UP ALL THESE ISSUES AND WE ARE
TRYING TO DO THAT.
WE HAVE BANKED URINE SAMPLES AND
AS FAST AS WE DO IT SOMETHING
ELSE APPEARS AND NEEDS TO BE
NIMBLE AND TRYING TO GET THAT OR
THOSE SUPPLEMENTS THAT ARE
WHATEVER WE CAN TO MOVE FORWARD.
ONE GREAT THING I THINK WE HAVE
BEEN ABLE TO DO IS SCIENCE.
WHAT HEAL CAN DO IS CONTINUE
WITH SCIENCE BECAUSE THERE ARE
MANY ISSUES IMPACTING CARE AND
WE CAN'T DEAL WITH THEM.
SCIENCE DOES ALLOW US TO GO TO
FDA OR OTHER AGENCIES AND DEA
AND EVERYWHERE ELSE TO SAY YOU
HAVE TO FIX THIS.
WE WERE ABLE TO DO THAT. MANY,
MANY PEOPLE DID IT WITH MATT ACT
THAT RESCINDED THE AMOUNTS OF
PEOPLE WHO COULD DWIF OUT AND
NEEDED X WAIVERS AND WE WERE
ABLE TO DO THAT.
EVEN SOMETHING LIKE LONG-ACTING
[INDISCERNIBLE] PREPARATIONS IN
ALL DISCLOSURE AND I'M STUDYING
THEM IN 7 DAYS AND SUPPLICATE
THAT HAS BEEN AROUND A WHILE I
HAVE TO LITERALLY GET RIGHT ARM
AWAY TO GET DOSE IN EMERGENCY
DEPARTMENT AND AMOUNT OF CRISIS
I HAVE TO GO THROUGH HAS ALMOST
-- I HAVE SAVED PEOPLES LIVES
AND THIS IS WHAT THEY REALLY
NEED AND I CAN'T GIVE IT TO THEM
AND WE ACTUALLY HAVE PUT PEOPLE
IN THE CAR TAKING THEM TO OPIATE
TREATMENT PROGRAM TO GET
MEDICATION ORDERED AND MEDICARE
AND MEDICAID WOULD PAY TO GET IT
THERE AND DROVE THE PATIENT
THERE THAT IS AN ESTATE THAT IS
PRETTY BLUE.
WE NEED THIS DATA AND WE HAVE TO
KEEP PRODUCING THIS.
WE CAN GO TO PEOPLE AND SAY AND
EVEN FDA AND IN TERMS OF WHAT
THE LIMITS ARE ON CERTAIN
MEDICINES GOING OUTSIDE OF THE
LIMIT OF GABAPENTIN FOR EXAMPLE,
EVEN. YOU KNOW, WHATEVER. EVEN
USING THE BU PEN EF RIN PATCH
USING IT FOR PAIN NOT OPIOIDS IS
CRAZY AND MORE STUDIES COMING
OUT THAT SHOW THESE ARE
EFFECTIVE MORE TOOLS WE HAVE TO
GO TO OTHER AGENCIES PUSHING FOR
HELP TO IMPROVE CARE OF OUR
PATIENTS.
THAT IS WHAT WE ARE DOING. GO
AHEAD.
>>I KNOW, GAIL. ABSOLUTELY.
COMMENTING YOUR POINT YOU MADE
EARLIER THAT BASICALLY GOT
IMPRINTED IN MY BRAIN. THIS IS
A VERY PRECISE RECOMMENDATION
AND GUIDELINE ON SOMETHING WE
CAN DO THAT CAN HELP TO CHANGE
PRACTICES DON'T MAKE ANY SENSE
AND NOT USING MEDICATIONS FOR
OPIOID USE DISORDER AND PATIENT
WITH ALCOHOL USE DISORDER.
>>RIGHT.
>>WHERE IS EVIDENCE THAT IS
HARMLEFUL TO START WITH?
THERE IS EVIDENCE THAT NAL
TRECHL YOEN IS EFFECTIVE IN
TREATMENT OF ALCOHOL USE
DISORDER AND EVIDENCE THAT
NOREPINEPHRINE IS REDUCING
CONSUMPTION AND THAT DATA IS OUT
THERE.
SO, I SORT OF -- BEING ABLE TO
VERY EXPLICITLY AND SO I -- I
TOOK AN ONLY ON THAT AND
REACHING OUT TO FDA TO SAY WHAT
DO WE HAVE TO GIVE YOU SUCH THAT
YOU CAN REMOVE CONSTRAINTS?
BECAUSE I THINK IT IS ACTUALLY
HARMING PEOPLE AND WORKING WITH
THEM BRINGING FORWARD CONCEPT
HOW CRUCIAL WE CAN COORDINATE
EFFORTS THEY ARE REGULATORY
AGENTS IS NOT SUFFICIENT FOR ME
TO SAY YOU HAVE TO CHANGE THIS.
WE HAVE TO GIVE THEM DATA THAT
MAKES THEM FEEL COMFORTABLE TO
DO IT.
THAT IS -- IN FACT, PROPOSAL
THAT TISHA PRESENTED EARLIER TO
GENERATE TRANSLATION AIMS TO DO
THAT AND ACCELERATING PROCESSES.
>>EXACTLY. THANK YOU.
>>CHRISTINE?
>>GOING BACK TO THIS THAT HAS
BEEN SIGNED BY BIDEN
ADMINISTRATION, WE ARE MAKING
ASSUMPTIONS THAT ELIMINATION OF
EX-WAIVER FOR PRESCRIBES OF BU
PREN EF RIN WILL HAVE A MASSIVE
IMPACT IN PRESCRIPTION PATTERNS.
I THINK THAT IT IS A UNIQUE
OPPORTUNITY FOR US TO REALLY
STUDY THIS MORE FORMALLY. AND
REALLY LOOKING AT IMPACT OF SUCH
A RADICAL CHANGE IN LOW ON TO
PRESCRIPTION PATTERNS AND THINK
THAT NOW WOULD BE TIME TO REALLY
SEE IMPACT.
I BELIEVE THAT THIS WILL TAKE
TIME.
LET'S BE VERY HONEST.
>>I AGREE 100%. IT BEHOOVES.
UNDERSTANDING WHAT CHANGING
POLICY WILL BE DOING TO ACCESS
OF TREATMENTS AND OTHER ASPECT
ABOUT IT NOT EVERYBODY
IMMEDIATELY INTEGRATED IS STATES
WILL BE IMPLEMENTING.
>> VERY LIKELY SOME STATES
WON'T ALLOW OPENING AND GIVES US
OPPORTUNITY TO INVESTIGATE ARE
DIFFERENCES BETWEEN STATES THAT
DO IT AND THOSE THAT DON'T AND
LIKE WHEN THEY WERE EXPANDING
MEDICAID AND WHEN WE ARE ABLE TO
DEMONSTRATE OUTCOMES ARE MUCH
BETTER FOR SUBSTANCE USE
DISORDER IN STATES EXPANDING
MEDIC
MEDICAID.
>>THIS IS A RECOMMENDATION AND
BEST PRACTICE IN ADDICTION
MEDICINE.
>>YES. YES. I BELIEVE IN DATA
AND BELIEVE IN THAT DATA WILL
WIN AT END OF THE DAY.
OVER HOPEFULLY PREJUDICES AND
POLITICS. WE WHETHER SEE.
>>I SAW HANDS NEXT.
>>YES. TO STAY WITH FOCUS ON
DATA AND SHIFTING A LITTLE BIT
EMPHASIS.
I'M WONDERING IF AT THIS POINT
WE ARE FAR ENOUGH ALONG IN HEAL
INITIATIVE WE ARE SEEING USE OF
DATA WHERE PEOPLE ARE ABLE TO
GET ACCESS TO AGGREGATE DATA ON
WHETHER THERE IS RELEVANT DATA
ACROSS DIFFERENT STUDIES AND
INITIATIVES AND WHEN THEY ARE
AGGREGATED AND IN LINE FOR MAYBE
ADDRESSING POINT -- ANOTHER
POINT THAT WASN'T NECESSARILY
FOCUS OF ORIGINAL DATA AND
WONDERING HOW IT IS GOING AND
DIDN'T HEAR MUCH ABOUT IT AT
THIS TIME AND MISSED IT IN FIRST
MEETING ABOUT YOU.
>>WE DIDN'T TALK ABOUT IT TOO
MUCH TODAY. NORA, WOULD YOU
LIKE ME TO ANSWER THAT ONE?
>>I THINK I WILL SPEAK FROM
PERSPECTIVE OF NOOIDA. NOT --
WE HAVE NOT YET. I MEAN, WE
HAVE OBVIOUSLY THROUGH CTN AND
MEDICATION DEVELOPMENT WE HAVE A
CLINICAL REPOSITORY THAT IS DATA
TO USE TO TRY TO VALIDATE
CRAVING. IT IS VERY SPECIFIC TO
PROJECTS THAT HAVE BEEN DONE
THROUGH NIDA.
ONE SPEAKING ABOUT INTEGRATION
ABOUT DIFFERENT TYPES OF STUDIES
FUNDED BY HEAL. RIGHT NOW FROM
NIDA, WE DON'T HAVE ANYTHING
THAT EMERGED BUT ARE WORKING
VERY HARD TO TRY TO TAKE
ADVANTAGE OF DATABASES THAT ARE
OBTAINED THROUGH HEALING
COMMUNITY STUDIES SO WE CAN
LEARN HOW DIFFERENT PRACTICES IN
FOUR STATES INFLUENCE OUTCOMES
AND IT IS ACTUALLY HAS BEEN MORE
CHALLENGING I WISH I WOULD SAY.
THIS DATA SHOULD BECOME
ACCESSIBLE AND CERTAIN DATABASES
STATES OWN AND SOME DON'T WANT
TO SHARE THEM. WE ARE WORKING
ON IT FOR NIDA PERSPECTIVE, NOT
YET.
>>YEAH. NIH-WIDE OR NIH HEAL
INITIATIVEWIDE WOULD SAY WE ARE
ON THE CUSP OF HAVING LOTS OF
HEAL FUNDED RESEARCH BE AT
RESULTS PHASE.
SO, SOME STUDIES BECAUSE OF
THEIR NATURE AND SOMETHING LIKE
A SURVEY OR SOMETHING MIGHT BE
READY NOW.
MOST OF OUR TRIALS ARE NOT.
THEY ARE STILL IN THE FIELD NOT
YET HAVING COMPLETED DATA
ACQUISITION.
SO, WE ARE -- WHAT WE HAVE BEEN
FOCUSED ON. I THINK THAT NORA
ELUDED TO THIS AS WELL PUTTING
INTO PLACE REALLY RESOURCES AND
INFRASTRUCTURE SO WHEN DATA ARE
KIND OF READY TO SHARE, WHICH IS
A FUZZY TARGET. IT IS IN A
POSITION WHERE IT WOULD BE
POSSIBLE TO SHARE IF THERE IS A
PLACE TO PUT THEM AND THERE IS A
WAY FOR METADATA TO BE
CATALOGED. THERE IS, YOU KNOW,
WE HAVE A STEWARDS TEAM THAT
HELPS THE INVESTIGATORS IDENTIFY
RIGHT REPOSITORIES AND RIGHT
INFORMATION TO SHARE.
NOW THAT THE NIH-WIDE PAIN
MANAGEMENT AND SHARING POLICY IS
IN PLACE THAT MEANS THAT GOING
FORWARD EVERYONE HAS TO DO THIS.
RESOURCES WILL BECOME EVEN MORE
USED AND VALUABLE.
I THINK REALLY -- I HAVE TWO
QUESTIONS TO YOU AND GROUP ABOUT
THAT.
FIRST BEING HOW DO WE GO OR
RECOGNIZING THAT WE ARE GOING
INTO THIS PHASE TO MAKE IT AS
KIND OF WIN/WIN AS POSSIBLE.
THE MOST HIGH-QUALITY DATA WITH
-- AND ALL THE MOST KIND OF
VALUE AND SENSE OF PURPOSE FROM
INVESTIGATORS NO THE JUST FROM
COMPLIANCE PERSPECTIVE BUT
RESEARCH AND SCIENCE PERSPECTIVE
HOW DO WE MAKE THIS VALUABLE TO
THEM?
ALSO, YOU KNOW, HOW WOULD YOU
LIKE TO HEAR ABOUT IT GOING
FORWARD?
WE ARE MOVING INTO A TIME WHERE
THERE WILL BE MORE DATA AND WILL
YOU BE IN A POSITION TO GIVE US
ADVICE ON IT.
>>WELL, I'M RESPONDING TO THE
FACT THAT WE HAVE A LARGE DATA
REPOSITORY YOU KNOW IN ABCD.
IT IS JUST I THINK SURPRISED
EVERYONE ASSOCIATED WITH THIS
HOW MUCH HAS COME OUT OF
SECONDARY DATA ANALYSIS THAT
PEOPLE WERE ABLE TO GO FIND
SOMETHING IN DATA BEING
COLLECTED THAT WERE VERY
VALUABLE AND DIFFERENT FROM WHAT
WE WERE THINKING ABOUT WHEN WE
DESIGNED THE STUDY THAT I THINK
IS THAT EXPERIENCE THAT IF DATA
LIKE MANY OF THE -- LIKE MANY
THINGS BEING COLLECTED IN THE
HEAL INITIATIVE ARE ACTUALLY
JUST MADE AVAILABLE FOR
SECONDARY ANALYSIS.
INVESTIGATORS OUT THERE WHO HAVE
A PARTICULAR BURNING QUESTION
WILL FIND WAYS TO REALLY EXPLOIT
THOSE DATA TO ANSWER INTERESTING
QUESTIONS AND I JUST -- IT HAS
JUST BEEN VERY MUCH FOR ME I
THINK I DON'T KNOW NORA HOW YOU
FEEL ABOUT THIS. THINGS COME
OUT OF ABC DATE THAW WE ARE
AMAZED THAT PEOPLE ARE ABLE TO
DO THESE THINGS THAT MAKES
SENSE.
BUT, YOU JUST HAVE TO -- I THINK
TO SOME EXTENT YOU HAVE TO
PROVIDE RESOURCES FOR OTHER
PEOPLE TO BRING OR FIGURE OUT
HOW TO USE IT.
NOT SO MUCH YOU HAVE TO USE
METADATA AND HAVE DATA
DICTIONARIES AND USE DATA USE
AGREEMENTS AND WAYS OF
MONITORING USE OF DATA AND ALL
THAT. I JUST THINK THAT WITH
SUCH AN ENORMOUS INVESTMENT
COLLECTING EXTREMELY VALUABLE
DATA THERE COULD BE LOTS MORE
MIND FROM IT IN THE FUTURE. IF,
YOU KNOW, A LITTLE MORE
ATTENTION WAS PAID TO MAKING IT
AVAILABLE FOR SECONDARY USES AND
PROCESS KNOWING SOMETHING IS
COLLECTED AND SEEING A QUESTION
COULD BE ANSWERED BY AGGREGATING
IT OR COMBINING IT OR SOMETHING
LIKE THAT.
>>THAT IS ABSOLUTELY THE
PURPOSE OF THE RENLTRY OF HEAL
TO MAKE THAT DATA AVAILABLE AND
IS MORE COMPLEX THAN ABC. ABC
IS ONE STUDY AND WE HAVE
MULTIPLE STUDIES CROSSING
THROUGH VERY, VERY DIFFERENT
TYPES OF COMMUNITIES AND
SCIENCE.
SO, THAT IS -- ALSO, THE OTHER
ASPECT THAT MAKES IT CHALLENGING
IS THAT ACCESS TO DATA AND
JUSTICE SETTINGS IS NOT THE SAME
THING AS SUCCESS THROUGH DATA TO
HEALTH CARE AND IS WHY WE ARE
WORKING VERY PROACTIVELY TO MAKE
THIS POSSIBLE.
YOU ARE ABSOLUTELY RIGHT. IT IS
NOT JUST COLLECTING DATA BUT
CREATING A FORMAT FOR DATA THAT
IS ALONGSIDE STRUCTURE AND
SUPPORT ALLOWING RESEARCHERS TO
ACCESS IT AND HAVE AN ANALYTICAL
METHOD TO DEPLOY IT IF THEY
DON'T HAVE THEM IN THEIR
INSTITUTION WHAT ABC HAS BEEN SO
SUCCESSFUL. AS COMPLEX AS CDC
IS THIS IS ANOTHER LEVEL.
>>I AGREE. I MUST SAY FROM OUR
EXPERIENCE WE HAVE TO THINK IN
TERMS OF DIFFERENT MODELS FOR
ACCESS AND SOME ARE MUCH MORE
RESTRICTED WHERE THERE IS HIGH
PRIORITY PULLING IT TOGETHER AND
MUCH MORE RESTRICTED ACCESS
POLICY AND VERY HIGH PRIORITY
THINGS DATA HAS TO REALLY BE
PULLED AND OTHERS THAT ARE MORE
FREE AND OPEN AND PEOPLE CAN
KIND OF HAVE MORE EASY ACCESS
AND MAYBE DATA SETS ARE BETTER
ANONYMIZED AND SOMETHING LIKE
THAT AND DON'T THINK ONE SHARING
MODEL WILL WORK AND FIRST TO SAY
I THINK IT DEPENDS WHAT KIND OF
DATA THEY ARE. AND WHAT THE
LEVEL OF PRIORITY OF THE
QUESTION IS.
THAT NEEDS TO BE ANSWERED AND WE
HAVE TO GO TO A MULTIMODAL
SECONDARY ANALYSIS KIND OF.
>>I AGREE. WE ARE ACTUALLY NOT
THE FIRST THAT WILL BE DEALING
WITH IT. ALL OF US HAVE BEEN
STRUGGLING WITH IT AND GENOME
INSTITUTE HAS BEEN STRUGGLING
WITH THIS.
SO, LET'S NOT INVENT THE WHEEL
BUT LEARN FROM THEM AND WHAT YOU
ARE SAYING AND I THINK THAT IT
WOULD BE A GOOD SUGGESTION.
REBEKAH, IT IS TO -- AT ONE
POINT WHEN IS TIMELY TO BRING
TOGETHER EXPERTS TO DETERMINE
EXACTLY THOSE DIFFERENT LEVELS
OF ENTRY AND ACCESS TO DIFFERENT
TYPES OF DATA THAT I THINK
HAVING A MODEL THAT CAN HELP US
WITH THIS WOULD FACILITATE HOW
TO GO ABOUT IT FURTHER.
>>YEAH. GREAT SUGGESTION.
THANK YOU FOR INVOKING ALL OF
THE RESEARCH PROGRAMS. ONE
THING THEY TAUGHT US IS YOU CAN
SUPPORT SMALL RESEARCH STUDIES
SPECIFICALLY ON THE QUESTION
TERRY ASKED. IS THIS USEFUL?
WHAT IF YOU TRY TO DO THIS
ANALYSIS BASED ON DATA?
IT COULD BE BOTH A PRESSURE TEST
OR BETA TEST THAT IS FOR YOUR
DATABASE WHILE ALSO KIND OF
GIVING SOME JUICE TO RESEARCH
COMMUNITIES.
I APPRECIATE THE SUGGESTIONS AND
ALL OF THIS REFERENCE.
I'M LOSING MY VOICE. WE HAVE
FIVE MINUTES LEFT FOR THE REST
OF THE MEETING.
GAIL,LY GIVE YOU THE LAST WORD.
>>OKAY.
>>I WILL GIVE A FEW SLIDES ON
NEXT STEPS BEFORE WE SAY
GOOD-BYE.
>>OKAY. LAST WORD AND IN TERMS
OF DATA TALKING ABOUT SOMETHING
ELSE AND TERMS OF DATE THAW IS
HELPFUL IS SOMEHOW IF THERE WAS
FUNDING THAT IS ALLOWED FOR
LARGE STUDIES WITH A
STATISTICIAN THAT WAS REALLY
RUNNING THAT INITIAL BIG TRIAL.
I AM ALWAYS WORRIED WHEN PEOPLE
TAKE SOMETHING THAT THE
VARIABLES ARE SO COMPLEX AND
THERE IS SO MUCH DATA THAT IN
FACT SOMEONE WILL MISS SOMETHING
OR MISINTERPRET SOMETHING. I
MEAN, I WORRY ABOUT THIS WHEN WE
PUBLISH MULTIPLE, MULTIPLE
STUDIES OUT OF PAPERS AND OUT OF
ONE STUDY AND WE WANT TO MAKE
SURE EVERYTHING IS CONSISTENT
AND WHY WAS IT THIS AND SOMEBODY
CHOSE SOMETHING AND IT DIDN'T
WORK OUT AND STATISTICIAN SAID
YOU HAVE WRONG VARIABLE THERE
AND PUTTING A PLEA AND SOMEHOW
WHEN PEOPLE DO LARGE SECONDARY
ANALYSIS THEY HAVE TO WORK WITH
A LITTLE BIT WITH A STATISTICIAN
WHO DID THE ORIGINAL WORK. AT
LEAST THEY CAN GO OVER WHERE
THEY ARE DRAWING FROM.
I THINK ABCD IS ONGOING AND YOU
HAVE ALL THAT WORK OR THOSE
PEOPLE THERE. ONCE STUDY STOPS
THAT STATISTICIAN IS NOT FUNDED
ANY LONGER AND I JUST -- THAT IS
MY MAJOR POINT.
>>POINT WELL-TAKEN.
GAIL, AS YOU KNOW THAT GENERATED
CONSTERNATION IN TERMS OF WAY
THAT NOREPINEPHRINE NAL TRECHL
YOEN DATE THAW IS EXACTLY A E
EXAMPLE OF --
>>EXACTLY.
>>OKAY. I'M GOING TO THEN JUST
SAY ONE MORE TIME THANK YOU TO
EVERYONE FOR ALL OF YOUR INPUT.
IT IS -- I GET A LITTLE
PHILOSOPHICAL BEING WITH THIS
GROUP THINKING BACK OVER THE
PAST FEW YEARS HOW MANY
WONDERFUL SUGGESTIONS YOU HAVE
MADE AND HOW MANY TIMES YOU HAVE
PUSHED US AND PUSHED RESEARCHERS
TO JUST DO A LITTLE BIT MORE AND
A YEAR OR TWO LATER WE COME TO
YOU AND I'M REALLY PROUD OF
PROGRESS WE MADE AND YET WE
STILL HAVE A BIG CHALLENGE IN
FRONT OF US AND BIG SET OF
INTERCONNECTED CHALLENGES AND
THANK YOU AGAIN FOR AMAZING
CONTRIBUTIONS AND THIS HAS BEEN
KIND OF TIME OF INCREASING NEW
RESEARCH INVESTMENTS AND ALSO
TURNING TO EXISTING INVESTMENTS
THINKING ABOUT THEM.
SO, WE IN HEAL WILL HAVE TO DO
WORK TO REALLY DETERMINE BEST
PATH FORWARD WITH YOUR COMMENTS
AND FEEDBACK OPEN AND THEY HAVE
BEEN INCREDIBLY VALUABLE TOWARDS
THAT GOAL. NEXT MEETING IS OVER
THE SUMMER. I WILL -- ERRIN OR
I WILL SEND YOU A POLL AROUND
WHEN WE WILL SCHEDULE THAT.
PLEASE LOOK OUT FOR E-MAILS FOR
NEXT SCHEDULES MEETING AND HEAL
INVESTIGATORS MEETING IS
ACTUALLY NEXT WEEK. I DON'T
KNOW THERE IS SLIDES FOR THAT.
PERHAPS NOT. HEAL -- 4TH ANNUAL
INVESTIGATOR MEETING IS JANUARY
21ST AND 22ND AND HYBRID MEETING
SOME WILL BE IN PERSON AND SOME
VIRTUAL AND WILL HEAR FROM MANY
FOLKS YOU HEARD FROM TODAY AND
IMPORTANTLY ARE INCREDIBLY
DETERMINED AND INNOVATIVE
RESEARCHER COMMUNITY AND SOME
EARLY FINDINGS AND AREAS FOR
COLLABORATION THEY HAVE. IF YOU
GO BACK ONE SLIDE, WE ARE ALSO
BRINGING YOUR ATTENTION AND THE
MEETING WILL BRING ATTENTION AS
WELL TO A NEW GROUP OF
INVESTIGATORS AND THEIR
COMMUNITY PARTNERS THAT WE
FUNDED THROUGH HEAL DATA
ECOSYSTEM THAT WERE IN LINE WITH
WHAT WE WERE DISCUSSING IN TERMS
OF REALLY BUILDING OUT A
MEANINGFUL AVENUE FOR ENGAGEMENT
WITH END USER OF FINDINGS WE ARE
SUPPORTING RESEARCH ON AND WHO
WILL TAKE THEM AND TRANSLATE
THEM INTO MEANINGFUL CHANGE FOR
PEOPLE WITH PAIN AND ADDICTION
AND THEIR COMMUNITIES AND SO
PLEASE LOOK OUT FOR ADDITIONAL
INFORMATION ABOUT THAT VERY RICH
CONSTALLATION OF NETWORK OF
COLLABORATORS TOO AND IS NOW 3
O'CLOCK ACCORDING TO MY COMPUTER
AND THANK YOU TO ERIN FOR
COORDINATING THIS AND FOR HEAL
TEAM THAT IS HELPING TO ALL OF
THE CO-CHAIRS OF OUR DIFFERENT
SCIENTIFIC TEAMS PRESENTING TO
YOU TODAY.
AND TO THE SCIENTISTS THAT
DEVELOPED THE CONCEPTS MANY
INTERDISCIPLINARY TEAMS WORKING
TOGETHER TO PUT FORWARD IDEAS
FOR YOU AND THANKING MEMBERS OF
THE HEAL EXECUTIVE COMMITTEE
THAT JOINED TODAY AND HELPED TO
FACILITATE A REALLY RICH
DISCUSSION AND TO ALL OF YOU
AGAIN AND IT AGAIN FOR ALL
CONTRIBUTIONS YOU MAKE TO HEAL
AND NORA WALTER, WOULD YOU LIKE
ANY FINAL, FINAL WORDS?
>>THANK YOU TO EVERYONE.
>>YEAH. SAME HERE. DON'T
FORGET WE WILL BE BACK ASKING
FOR MORE HELP. THANK YOU AGAIN.
>>THANK YOU, EVERYONE.
>>THANK YOU ALL.
>>BYE, BYE.
>>THANK YOU.