THANK YOU SO MUCH.
WELCOME EVERYBODY TO THE HEAL
MULTI-DISCIPLINARY GROUP
MEETING.
I WANT TO APPRECIATE THE MEMBERS
FOR MAKING THE EFFORTS AND
MOVING THINGS ON YOUR CALENDAR
TO MAKE THE MEETING AND THE
MEETING WAS ORIGINALLY SCHEDULED
FEBRUARY 10.
I WOULD LIKE TO REMIND EVERYONE
THIS MEETING IS AN OPEN MEETING
AND BEING BROADCAST TO THE
PUBLIC.
PREPARE YOUR SELVES ACCORDINGLY.
AS A REMINDER WE WERE ABLE TO
COMPLETE THE CLOSED PORTION AS
SCHEDULED FEBRUARY 10, SO
THERE'S NO CLOSED SESSION JUST
THE OPEN SESSION.
I HAVE TO ACKNOWLEDGE IT'S BEEN
A TUMULTUOUS COUPLE OF MONTHS
HERE AND WE'RE GRATEFUL TO BE
ABLE TO TALK WITH YOU TODAY
ABOUT THE SCIENCE UNDERLYING THE
HEAL INITIATIVE AND YOU'RE A
TERRIFIC GROUP OF EXPERTS AND
APPRECIATE YOUR GUIDE IN THE
HEAL INITIATIVE AS IT MOVES
FORWARD.
AS A BRIEF REMINDER FOR THOSE
COMING IN TO THE MEETING WE
ASSIST THE NIH INSTITUTE AND
CENTER ADVISORIES COUNCILS TO
MAKE SURE IT MEETS THE GOALS TO
ADDRESS THE ONGOING PUBLIC
HEALTH EMERGENCY OF OPIOID
RELATE THE OVERDOSE DEATHS AND
INFORM STRATEGIES TO ADDRESS
THIS AND IMPROVE THE
UNDERSTANDING MANAGEMENT AND
TREATMENT OF PAIN AND IMPROVING
THE PREVENTION AND TREATMENT OF
OPIOID USE ADDICTION AND
OVERDOSE.
THIS GROUP PROVIDES A FORUM TO
ENGAGE PARTNERS IN THE PRIVATE
SECTOR AND COMMUNITY TO PROVIDE
A TRANSPARENT VENUE FOR IT
STAKEHOLDERS AND EXCHANGE
INFORMATION IN AND ACROSS THE
HEAL INITIATIVE PROJECTS.
WILL THAT I'LL HAND IT TO
DIRECTOR VOLKOW THE DIRECTOR OF
THE HEAL INITIATIVE AND
INSTITUTE.
>> GOOD AFTERNOON EVERYONE AND
IT'S A PLEASURE TO BE HERE AND
I'M GLAD WE'RE ABLE TO
RESUSCITATE THE OPEN SESSION
BECAUSE IT'S A WAY TO
COMMUNICATE WITH ALL OF YOU SOME
OF THE ADVANCES THAT HAVE BEEN
POSSIBLE BECAUSE OF THE HEAL
INITIATIVE.
AND SINCE WE RELY ON YOUR INPUT
AND IT DOES REFLECT YOUR
LEADERSHIP AND VISION IN TERMS
OF WHAT ARE THINGS THAT ARE
CONSEQUENTIAL.
THAT'S WHAT I'M GOING TO BE
DOING TODAY.
I AM SELECTING CERTAIN THINGS
THAT I WANT TO HIGHLIGHT.
OBVIOUSLY I DON'T HAVE TIME TO
PRESENT EVERYTHING THAT'S
HAPPENED SINCE WE LAST MET AND
THAT'S WHAT I'M GOING TO DO.
I'M NOW GOING TO SHARE MY
SCREEN.
I'VE NEVER SHARED IN THIS
PLATFORM SO I ASSUME IT'S
STRAIGHTFORWARD.
LET ME SEE.
IF IT'S NOT STRAIGHTFORWARD --
NO, THIS IS NOT THE ONE.
>> IT LOOKS GREAT TO US, NORA.
IT LOOKS GREAT ON OUR END.
>> EXCEPT DHTHIS IS NOT THE LATT
VERSION.
HOLD ON.
THIS IS WHAT HAPPENS WHEN YOU
HAVE SOMEONE SO OBSESSIVE I LOOK
AT THINGS UNTIL THE LAST MINUTE.
I MAY HAVE TO LIVE WITH IT GUYS.
>> THIS IS RACHEL KELLY I HAVE
YOUR MOST RECENT SLIDE DECK UP
IF YOU WANT ME TO SHARE.
>> Director Volkow: I HAVE IT
HERE AND ONE THING THAT'S
EXCITING AND I'M PRESENTING TO
ALL OF YOU IS WE ARE SEEING SOME
VERY GOOD NEWS AS IT RELATES TO
THE OVERDOSE CRISIS.
YOU CAN SEE THE NEXT SLIDE
YOU'LL UNDERSTAND WHY I SAY
THAT.
WHAT YOU SEE IS DECREASES IN
OVERDOSE DEATHS THAT IN THE PAST
22 MONTHS AND IN THE GREEN ARE
PERCENTAGE OF CHANGES AND IT'S
BEEN DRAMATIC BECAUSE WE'VE BEEN
SEEING FOR YEAR AFTER YEAR
SEEING THE NUMBERS IN RED WITH
SIGNIFICANT INCREASES THE
HIGHEST WERE 30% DURING THE
FIRST YEAR OF THE COVID
PANDEMIC.
BUT SO TO SEE A DECREASE IS
QUITE REMARKABLE BUT TO SEE THIS
LEVEL OF DECREASE IS SO MUCH
MORE.
SO WHAT WE'RE SEEING IN THE
COUNTRY IS A 25% REDUCTION IN
OVERDOSE MORTALITY OVER ALL.
IF YOU LOOK AT THE DIFFERENT
COLUMNS IT TELLS YOU WHAT ARE
THE DRUGS THAT HAVE BEEN
ASSOCIATED WITH THAT REDUCTION
IN OVERDOSE DEATHS.
AND I NEED TO YOU LOOK AT THE
ONE TO THE LEFT THE THIRD COLUMN
TO THE RIGHT -- TO THE LEFT AT
THE END OF THE TABLE YOU SEE
SYNTHETIC OPIOIDS AND FENTANYL
AND 30% DECLINE.
WHAT'S SO REMARKABLE ABOUT IT IS
THE NUMBERS DO NOT APPEAR TO BE
JUST RANDOM NOISE AND WITH
VARIATIONS THEY HAVE BEEN QUITE
STABLE.
AND IT'S NOTABLE FENTANYL HAS
BEEN THE MAIN DRIVER OF OVERDOSE
DEATHS AND IT'S GOING DOWN
DRAMATICALLY.
THERE CONTINUE TO BE SIGNIFICANT
REDUCTIONS IN THE OTHER DRUGS
FROM OPIOID ANALGESICS AND
HEROIN AND IMPORTANTLY SEEING
REDUCTIONS IN OVERDOSE DEATHS
FROM COCAINE AND METHAMPHETAMINE
WHICH HAVE RECENTLY STARTED TO
CONTRIBUTE TO THE RISES IN
OVERDOSES.
MOST WITH COCAINE ARE ASSOCIATED
WITH FENTANYL AND 75% THAT DIE
FROM COCAINE HAVE FENTANYL AND
MORE THAN 60% HAD FENTANYL ON
BOARD.
THE NEXT SHOWS DATA.
THIS IS IMPORTANT BECAUSE WE SEE
THE REAL EFFECT IT'S NOT A
VARIATION.
STARTING IN 2023, JULY, AUGUST
WE'RE STARTING TO SEE ALL THE
DRUGS IN GREEN AND DIVIDED INTO
OPIOI
OPIOIDS AND YOU'RE COMBINING
COCAINE AND METHAMPHETAMINE.
AND ONE OF THE THINGS I HAVE
BEEN VERY CURIOUS ABOUT AND I
HOPE YOU NOTICE THE COVID
PANDEMIC IS WHERE WE SEE THE
STEEP RISE AND CONTINUED TO RISE
AND YOU SEE THAT BETWEEN 2019
AND 2020 AND THE HIGH INCREASE
IN OVERDOSE DEATHS.
SO ONE OF THE QUESTIONS WE WANT
TO ANSWER IS THESE REDUCTION
JUST THE FACT WE NO LONGER HAVE
THE COVID PANDEMIC AND STRESSORS
RESPONSIBLE FOR THE REDUCTION.
THAT ONE IS GOING TO 2019
LEVELS.
WHAT I CAN TELL YOU AND IF YOU
SEE THIS IS 2019 AND SO IF WE
MOVE THIS IN A HORIZONTAL LINE
ALL OVER AND PUSH IT HERE YOU
CAN SEE -- I CANNOT HAVE THE
CURSER ON MY COMPUTER BUT SEEING
THE VALUES OF OVERDOSE DEATHS
ARE LOWER THAN WE HAD IN 2019 CH
IS THE YEAR BEFORE THE COVID
PANDEMIC INDICATING THESE
REDUCTIONS ARE NOT JUST A RESULT
OF THE RESOLUTION OF ALL THE
ADVERSE CIRCUMSTANCES LINKED
WITH THE PANDEMIC.
BUT UNDERLINE OTHER FACTORS.
OBVIOUSLY IT'S VERY IMPORTANT
FROM THE FACET OF SCIENCE TO
UNDERSTAND THE FACTORS DRIVING
THE DECLINE IN OVERDOSE DEATHS.
I WOULD SAY THERE'S NOT ONE
SIN
SINGLE FACTOR.
THERE'S MULTIPLE FACTORS
INCLUDING THE FACT THE MOST
VULNERABLE PEOPLE MAY HAVE DIED.
IMPORTANTLY THERE MAY BE A SHIFT
IN FENTANYL THAT GETS INTO OUR
COUNTRY ALSO OTHER INTERVENTION
S ACCELERATED WITH RESOURCES AND
THE RESEARCH PROJECT PROGRAMS WE
GOT FROM HEAL THAT HAVE MADE
THIS POSSIBLE.
WHAT ARE THERE?
THE FIRST ONE IS THE RESEARCH
PROGRAMS WE'VE BEEN ABLE BECAUSE
BECAUSE OF HEAL RESOURCES.
IT WAS CLEAR THAT WE HAVE
MEDICATION ARE VERY EFFECTIVE
FOR TREATMENT OF OPIOID USE
DISORDER AND IF PEOPLE ARE ON
THE MEDICATIONS THE RISK OF
OVERDOSE IS DRAMATICALLY
REDUCED.
AND WE HAVE NALOXONE ANTAGONIST
VERY EFFECTIVE IN REVERSING AN
OVERDOSE.
FOR THESE MEDICATIONS FOR OPIOID
USE DISORDER TO PREVENT
OVERDOSES IT HAS TO BE MADE
AVAILABLE AND ACCESSIBLE.
IT WAS VERY CLEAR IN 2018 WHEN
WE GOT THE DOLLARS FOR THE HEAL
INITIATIVE THE MEDICATION WAS
VASTLY UNDER UTILIZED WHETHER
OVERDOSE PREVENTION OR
MEDICATION.
TAKING ADVANTAGE OF KNOWLEDGE
GAINED THROUGH THE YEARS OF
RESEARCH IN EPIDEMIOLOGY IT
BECOMES CLEAR THERE'S NOT
SUFFICIENT PROGRAMS IN THE
UNITED STATES TO PROVIDE AND
EXPAND THE USE OF THE
TREATMENTS.
AND THERE'S A HEALTH CARE
INFRASTRUCTURE THAT COULD BE
UTILIZED IF APPLIED TOWARDS THE
SCREENING AND TREATMENT FOR
PEOPLE WITH OPIOID USE DISORDER.
WE RESTRUCTURED THE CHEMICAL
TRIAL NETWORKS TO TRY TO
MAXIMIZE THE DEVELOPMENT OF
MODELS THAT WILL ENABLE US TO
BRING THE TREATMENT THE
RECOGNITION AND TREATMENT AND
THE FOLLOW-UP OF PEOPLE WITH AN
OPIOID USE DISORDER IN HEALTH
CARE SYSTEMS.
AND MULTIPLE MODELS AND I'LL
HIGHLIGHT ONE OF THEM.
WE RECOGNIZED BASED ON DATA THAT
PUBLISHED AT LEAST 25% OF THE
PEOPLE THAT HAVE DIED FROM AN
OVERDOSE HAD IN THE PAST 12
MONTHS HAD A CONTACT WITH
JUSTICE SETTINGS.
25% OF THEM.
IMPLICATING JUST WITH THE HEALTH
CARE SYSTEM BETWEEN EMERGENCY
DEPARTMENTS PREDOMINANTLY OR
EMERGENCY SERVICES CLOSE TO 60%
TO 65% OF PEOPLE HAD CONTACT 12
MONTHS BEFORE THEY DIED.
HIGHLIGHTING THE MISSED
OPPORTUNITY WE HAD BY NOT HAVING
CREATED A SYSTEM THAT ALLOWS TO
DO THE SCREENING AND
INTERVENTION IN THOSE PEOPLE.
IMPLEMENTATION MODELS TO BRING
THESE INTO THE HEALTH CARE
SETTING AND THE JUSTICE SETTING
AND THAT'S WHAT THE J COM
PROGRAM IS ALL ABOUT.
FINALLY, IT WAS CLEAR THE LOCAL
SOLUTION BROUGHT UP BY COMMUNITY
S ALSO WERE AN IMPORTANT WAY TO
PROVIDE TREATMENT ON INDIVIDUALS
THAT OTHERWISE WOULD NOT GET
TOUCHED THROUGH THE HEALTH CARE
SYSTEM OR SETTING AND EVEN IF
THEY WERE ACCESSING THE OTHER
SYSTEMS THEY WOULD BE
DISCONNECTED ONCE THEY GOT IN
THE COMMUNITY.
WE PRIORITIZED INTERVENTIONS
HEALTH CARE, JUSTICE AND
COMMUNITY.
SO TODAY I'M GOING TO HIGHLIGHT
WHERE WE ARE WITH RESPECT TO
INVESTMENTS WE HAVE DONE IN
BRINGING SCREENING INTO A HEALTH
CARE SYSTEM.
WHEN THEY HAVE BUPRENORPHINE
DIRECTLY THEY HAVE BETTER
TREATMENT AND OVER ALL OUTCOMES.
THIS IS DIFFERENT FROM WHAT WAS
TYPICALLY FELT WAS NOT SOMETHING
THAT COULD BE DONE IN THE
EMERGENCY DEPARTMENT.
THEY'VE TRIED TO DOCUMENT THE
SAFETY OF THE INTERVENTIONS AND
RESOURCES NECESSARY TO BE ABLE
TO DO SO AND FOLLOW-UP OF COURSE
WITH PATIENTS.
AND HAVE A NETWORK TO BRING
ACROSS THE STATES THIS MODEL FOR
THE BUPRENORPHINE IN THE
EMERGENCY ROOM DEPARTMENT AND
EVALUATE THE AFFECTS OF HIGHER
DOSES EXTEND ED AND RECENTLY A
PAPER CAME UP WITH THE RESULTS
OF A MODEL IMPLEMENTED IN
PARTNERSHIP WITH THE CTN AND THE
STATE THAT ACTUALLY SHOWS HOW
MANY NEW CASES DEAL WITH OPIOID
USE DISORDER WEREN'T PRESCRIBED
AND HOW MANY AND HOW MANY
INCREASED DURING THAT TIME
PERIOD.
HOW HAVE BEEN ABLE TO IMPLEMENT
THIS IN EMERGENCY ROOM
DEPARTMENTS AND BUPRENORPHINE AT
THE EMERGENCY ROOM DEPARTMENT
AND TENFOLD INCREASE IN
PROVIDERS GIVING BUPRENORPHINE.
I HIGHLIGHT THIS EXAMPLE BECAUSE
WE'RE ABLE TO CHANGE A CULTURE
AND THE WAY THINGS ARE DONE AND
THREES A SEPARATE TREATMENT
SYSTEM IN OUR COUNTRY TO ADDRESS
THE NEEDS AND IT'S A MISSED
OPPORTUNITY.
IT SHOWS HOW CRUCIAL THIS IS IN
MODIFYING PRACTICES.
AND FOUR PROJECTS AT THE
CLINICAL TRIAL NETWORK IN
PARTNERSHIP WITH THE HEALTH CARE
SYSTEM.
ONE IS AN EMERGENCY DEPARTMENT
AND THE OTHERS ARE DONE IN
PRIMARY CARE AND IN TREATMENT
CENTERS THAT RELATE TO MOTHER
WELL BEING.
THESE ARE PROJECTS THAT HAVE
BEEN COMPLETED AND I HOPE I'VE
BEEN ABLE TO PRESENT IN THE NEXT
MULTI-DISCIPLINARY GROUP AN
UPDATE ON THE RESULTS.
THE ONE IS THE TREATMENT OF
WOMEN WITH AN OPIOID USE
DISORDER WITH EXTENDED RELEASE
BUPRENORPHINE PROVIDING MANY S
AND IN GENERAL S BETTER OUTCOMES
AND WHAT HAS NOT BEEN TESTED EN
MOTHERS AND PREGNANT WOMEN.
THE SECOND IS A MODEL THAT HAS
FINISHED EVALUATING AND
INITIATING BUPRENORPHINE WITH
HIGH DOSES IN THE EMERGENCY ROOM
DEPARTMENT.
AN AREA THAT'S GENERATED CONCERN
WITH THE CONCERN OF FENTANYL IF
YOU GIVE A HIGH DOSE YOU CAN
TRIGGER A WITHDRAWAL.
THE TRIAL EVALUATES HOW TO DO IT
AND DOCUMENTS SAFETY.
AGAIN THE RESULTS WILL BE COMING
UP HOPEFULLY SOON.
ANOTHER IMPORTANT TRIAL THE
THRESHOLD OPIOID USE DISORDER
TRIAL IS CRUCIAL.
WHILE WE'VE DONE A LOT OF
RESEARCH HOW TO TREAT MODERATE
TO SEVERE OPIOID USE DISORDER
WHERE WE GIVE MEDICATIONS LIKE
BUPRENORPHINE IS NOT NECESSARILY
THE CASE WHERE YOU HAVE SOMEONE
SCREENING FOR A MILD OPIOID USE
DISORDER WHERE THE MEDICATIONS
MAY NOT NECESSARILY BE
INDICATED.
THE QUESTION ARE WHAT ARE THE
ISSUES THAT NEED TO BE ADDRESSED
AND HOW DO YOU SUPPORT THE
INDIVIDUAL SO THEY DON'T
ESCALATE TO THE MODERATE TO
SEVERE OPIOID USE DISORDER.
AND FINALLY A PROJECT DONE IN
THE EMERGENCY ROOM DEPARTMENT
BUT TAKES ADVANTAGE OF A PEER
RECOVERY INTERVENTION TO ENSURE
PATIENTS THAT END UP IN THE
EMERGENCY ROOM DEPARTMENT ARE
LIKELY TO STAY IN TREATMENT.
AGAIN, THE INVESTIGATORS ARE
DOING ANALYSIS AND HOPE YOU CAN
UPDATE YOU SOON.
IN THE NEXT SLIDE I WANT TO MAKE
YOU AWARE OF THE FOUR PROJECTS
WE'RE PLANNING TO LAUNCH THROUGH
THE CLINICAL TRIAL NETWORKS THAT
RELATE TO ADDRESSING THE URGENT
NEEDS THAT ARE STILL THERE.
ONE OF THEM IS POPULATIONS AT
HIGHER RISK WHERE IT'S HARDER
FOR PEOPLE TO ACCESS TREATMENT.
THAT IS THE INTERVENTION.
ONE OF THE PROJECTS AIMS AT
EXPANSION OF MEDICATIONS FOR
OPIOID USE DISORDER AND HERE
AGAIN THERE'S TREMENDOUS
ADVANTAGE OF HAVING ACCESS TO
EXTENDED RELEASE BUPRENORPHINE
BUT IT HAS NOT BEEN EVALUATED.
THE SECOND IS AN INTERVENTION IN
THE PRIMARY CARE SETTING DECH
DEF -- CARE SETTING AND IN MANY
DAYS ACCESSIBLE AND OPPORTUNITY
TO DETECT AND SCREEN AND DO
PREVENTION INTERVENTION THAT HAS
BEEN SHOWN CAN ACTUALLY BE VERY
INFLUENTIAL.
IN THIS CASE, THE TRIAL IS GOING
TO BE TARGETING PARTICULARLY
INDIVIDUALS AT VERY HIGH RISK OF
OVERDOSES.
THOSE ARE PEOPLE WHILE THEY MAY
NOT HAVE AN OPIOID USE DISORDER
AND MISUSING OPIOIDS BUT ALSO
MISUSING OTHER SUBSTANCES.
PEOPLE WHO TEND TO COMBINE
ALCOHOL AND DIAZEPINES AND OTHER
WITH ALCOHOL VERSUS SOMEONE ONLY
USING OPIOIDS.
THE THIRD IS THE ONE THAT IS
GOING TO TAKE THE BUPRENOROHINE
AND THE RATE OF WITHDRAWAL
SYSTEMS IN THE PATIENTS WITH
HIGH DOSES IS NOT VERY DIFFERENT
FROM THOSE INITIATED WITH LOW
DOSES OF BUPRENORPHINE.
AND THE OTHER IS LOOKING AT AN
ADOLESCENT TO BE AT RISK TO
OPIOID USE DISORDER AND WE DON'T
KNOW HOW A CLINICIAN TO TREAT
SOMEONE WITH ACUTE SEVERE PAIN
IN ADOLESCENCE WHO ARE AT HIGHER
RISK OF ADDICTION THAN ADULTS
ARE.
THESE ARE THE FOUR NEW PROJECT
AND WE HAVE PROGRAMS AND
EXPANDING THEIR SUCCESS AND ONE
OF THE MOST CONSEQUENTIAL FACTOR
TO REDUCTION IN OVERDOSE DEATHS
BUT IT'S CLEAR WE STILL HAVE
MAJOR CHALLENGES.
NUMBER ONE, MANY OF THE
OVERDOSES HAPPENING AND MANY OF
THE FATAL OVERDOSES HAVE
MULTIPLE SUBSTANCES AND THAT MAY
BE ONE OF THE REASONS THE PERSON
COULD NOT BE RESUSCITATED.
WHILE NALOXONE IS EFFECTIVE FOR
A PURELY OPIOID OVERDOSE IT'S
NOT THE CASE WHEN YOU HAVE THE
COMBINATION OF ALCOHOL OR BENZOS
OR STIMULANTS AND NEED
ALTERNATIVE INTERVENTIONS FOR
OVERDOSES DUE TO POLY
SUBSTANCES.
THAT IS A MAJOR NEED.
WE'RE SEEING A SIGNIFICANT RISE
IN SUBSTANCES WITH COCAINE AND
FENTANYL AND THOSE WITH A
COCAINE OR METHAMPHETAMINE USE
DISORDER THEY MAY HAVE CONSUMED
UNBEKNOWNSTED TO THEM CONSUMED
FENTANYL AND PUTS THEM AT HIGHER
RISK OF OVERDOSING BECAUSE THEY
DON'T HAVE TOLERANCE.
AND WE DON'T HAVE ANY MEDICATION
APPROVED FOR THE OVERDOSE OF
STIMULANT USE DISORDER.
THIS IS A TREMENDOUS GAP NEED
AREA.
WE'RE PRIORITIZING IT IN TERMS
OF WHETHER IT'S MEDICATIONS OR
BIOLOG
BIOLOGICALS OR BEHAVIORAL
INTERVENTIONS.
AND IN TERMS OF WHERE THE
SCIENCE IS LEADING US,
INTERVENTIONS NOT SPECIFIC FOR
ONE ADDITION LIKE OPIOIDS AND
METHADONE SPECIFIC OR OPIOID USE
DISORDER BUT THE TARGET COMMON
MOLECULAR PROCESSES THAT I
ENGAGE WITH MULTIPLE ADDICTIONS.
SUCH THAT YOU CAN THEN USE THEM
TO TREAT POLYSUBSTANCE USE
DISORDER THAN SUBSTANCES
ISOLATED.
THOSE ARE THE LARGE CLUSTER
AREAS WE'RE PUSHING IN
DEVELOPMENT.
LET ME GIVE AN EXAMPLE FOR AN
OVERDOSE WHERE ARE WE?
NEXT SLIDE SHOWS TWO STRATEGIES
WE'RE USING FOR ADDRESSING
REVERSAL OF OVERDOSES WITH
FENTANYL OR AMPHETAMINE AND ONE
IS A MONOCLONAL ANTIBODY WITH
STRONG AFFINITY.
IT BINDS TO FENTANYL IN THE
BLOOD SEQUESTERING IT SO IT
CANNOT GET IN THE BRAIN OR INTO
OTHER ORGANS.
IT RESTRICTED THE PHARMACOLOGIC
AFFECT OF THE AGENT.
THE OTHER BEAUTY ABOUT THESE
MONOCLONAL ANTIBODY IS THE
PROTECTION LASTS AT LEAST FROM
DATA ON NON HUMAN PRIMATES
APPROXIMATELY FOUR WEEKS.
THEY'RE ON PHASE TWO OF THE
PHASE II CLINICAL STUDY AND ONE
TRAPS THE DRUG IN THE
BLOODSTREAM AND A SEQUESTRATION
DRUG THAT BIND AT HIGH AFFINITY
AND BY BINDING IT INTERFERES
WITH IT BEING DELIVERED INTO THE
BRAIN.
THEY STARTED THEIR PHASE II
CLINICAL TRIALS LAST WEEK.
SO HOPEFULLY BOTH ARE VERY
DIFFERENT IN TERMS OF MET
METHODOMET
METHODOLOGIES BUT GIVE TREATMENT
TO REVERSE WITH FENTANYL OR
OVERDOSES WITH DRUG
COMBINATIONS.
THE PLATFORM HAS THE FLEXIBILITY
AND OPPORTUNITY TO THEN ADAPT TO
OTHER DRUGS THAT MAY BE EMERGING
AS WE HAVE SEEN IN THE PAST FEW
YEARS.
THE SECOND EXAMPLE IS THE ONE OF
TARGETING INTERVENTIONS THAT ARE
NOT ONE SPECIFIC ADDICTION BUT
COULD BE VALUABLE AND TAKING
ADVANTAGE OF AVAILABILITY OF
MEDICA
MEDICATIONS THAT ARE A RECEPTOR
1 AGONIST USED FOR OBESITY OR
DIABETES NOW BEING WIDELY USED
VERY EFFECTIVE AND WHERE THE
REPORTS FIRST STARTED TO NOTICE
THERE WERE PEOPLE WITH A
SIGNIFICANT REDUCTION IN THEIR
DESIRE FOR ALCOHOL OR SMOKE OR
TAKE OTHER DRUGS.
AND THAT OF COURSE IN CLINICAL
DATA HAD SHOWED INDEED THESE GLP
1 DRUGS PREVENTED RELAPSE IN
ANIMAL MODELS OF ADDICTION.
THEY ACTUALLY -- THEY'VE BEEN
SHOWN WIDELY INVESTIGATED FOR
ALCOHOL USE DISORDER AND TOBACCO
AND ALCOHOL USE DISORDER AND
THERE'S BEEN TWO CLINICAL
TRIALS.
ONE DONE AT DENMARK AND ONE IN
THE UNITED STATES.
ONE WAS WITH A FIRST GENERATION
GLP DRUG AND THE ONE IN THE
UNITED STATES WITH SEMAGLUTE IDE
AND SHOWED REDUCTION IN SMOKING.
AND IT INDICATES REDUCTION IN
OVERDOSES IN PATIENTS WITH
OPIOID USE DISORDER AND
COMBINATION OF SEMAGLUTIDE AND
YOU CAN CLEARLY SEE SIGNIFICANT
REDUCTIONS IN THE RISK.
THIS IS FROM ELECTRONIC HEALTH
RECORDS.
AND OTHER STUDIES HAVE BEEN
PUBLISHED WITH EQUIVALENT
RESULTS FOR OTHER DRUGS.
TO YOUR RIGHT YOU HAVE
PRELIMINARY DATA ON A PILOT
STUDY SHOWING REDUCTION IN
PATIENTS WITH OPIOID USE
DISOR
DISORDER.
SO, A PRIORITY IN DEVELOPMENT OF
MEDICATIONS IS BRINGING THESE TO
A RANDOMIZED CLINICAL TRIAL FOR
STIMULANT DISORDER AND WE'RE
USING IT FOR THE CLINICAL TRIAL
AND CONTACTS THROUGH THE V.A.
HOSPITAL TO ACCELERATE THE
DEVELOPMENT OF THESE TRIALS AS
WELL AS FUNDING RESEARCHERS TO
ACTUALLY DO THE STUDIES TO
DETERMINE WHETHER IN FACT IT'S
EFFICACIOUS OR NOT.
AND THEN I WANT TO GIVE A FAST
UPDATE OF OUR SMALL BUSINESS
PROGRAM FUNDED WITH HEAL DOLLARS
ALSO EXTREMELY SUCCESSFUL.
WE HAVE THE HUB, 14 FOR PHARMA
COTHERAPEUTICS AND FDA REGULATED
THERAPEUTIC DIAGNOSTIC DEVICES
AND NON-REGULATED PRODUCT AND
RESEARCH TOOLS.
I'M SHOWING PRODUCTS THAT HAVE
BASICALLY BEEN APPROVED BY THE
FDA THAT ACTUALLY ARE OUT IN THE
MARKETS.
ONE IS A STIMULATION DEVICE THAT
TAKES ADVANTAGE OF THE FACT THAT
THE VAGUS NERVE ONE IN THE LOBE
OF THE EAR AND HAS BEEN SHOWN IT
DECREASES WITHDRAWAL IN ACUTE
WITHDRAWAL SYNDROME BEING TESTED
ON NEONATES.
ALSO TESTED FOR THE POSSIBILITY
IT CAN IMPROVE OUTCOMES IN
PEOPLE WITH OPIOID USE DISORDER.
THE OTHER ONE PRAPELA IS A
COMPANY THAT DEVELOPED THE
TACTILE STIMULATION DEVICE TO
TREAT NEONATAL ABSTINENCE
SYNDROME.
IT'S SIMPLE.
YOU PUT IT IN THE CRIB AND IT
VIBRATES AND DECREASES THE
IRRITABILITY OF THE NEONATES AND
ONE IS ISTANOSIS DETECTING
FENTANYL WITH A TEST STRIP.
AND THEY WERE NOT AVAILABLE FOR
PHYSICIANS TO DETERMINE IF
SOMEONE HAD AN OVERDOSE FROM
FENTANYL OR NOT.
THIS HAS BEEN CLEARED BY CLIA
AND NOW WIDELY AVAILABLE AND
IMPROVING IN THE HEALTH CARE
SYSTEM TO THE EXTENT EMERGENCY
ROOM OR OTHER SETTINGS HAVE
AFFECTED BY FENTANYL.
THE LAST IS WHERE DO WE GO FROM
HERE AND THE FUTURE.
THERE'S STILL A MAJOR NEED AND
THERE'S AREAS WE HAVE NOT BEEN
ABLE TO ADVANCE THE SCIENCE AS
MUCH AS WE'D LIKE OR NEGLECTED.
I'LL HIGHLIGHT SOME OF THEM.
IMPORTANTLY WE NEED TO ENHANCE
PREVENTION IN WAYS THAT IS GOING
TO BE SUSTAINABLE AND ACCESSIBLE
AND ADVANCE TREATMENT.
WE ALSO NEED TO ADVANCE
RECOVERY.
THIS IS A SPACE WHERE THERE'S
BEEN LIMITED RESOURCES AND AS A
RESULT OF THAT THERE'S A NEED TO
HAVE THE SUPPORT SYSTEMS
NECESSARY FOR RECOVERY.
WE NEED TO CONTINUE TO SUPPORT
THERAPEUTIC STUDIES ON POLY
SUBSTANCE USE AND OVERDOSES SO
WE CAN KNOW WHAT DRUGS ARE
AVAILABLE AND WHAT IS THE
GEOGRAPHIC DISTRIBUTION OF THE
DRUGS AND VARIABILITY.
WE ALSO CLEARLY HAVE RECOGNIZED
FROM THE BEGINNING AND YOU CAN
HAVE ADVANCED THE AREA OF
SCIENCE OF COMORBIDITIES AND
IT'S CLEAR PEOPLE WITH COMORBID
CONDITIONS ARE AT HIGHER RISK OF
DRUGS AS A WAY OF MEDICATIMEDIC.
THERE'S A REDUCTION IN AND IT'S
NOT HOMOGENOUS AND SOME PLACES
THE OVERDOSE MORTALITY ARE
EXTREMELY HIGH TO THE LEVELS OF
THE COVID PANDEMIC.
I MENTIONED RURAL AREAS AND
NATIVE AMERICANS HAVE EXTREMELY
HIGH RATES OF OVERDOSE DEATHS.
THE FINAL ONE IS SOMETHING WE
ALL ARE INVOLVED WITH AND NEED
TO BUILD TOGETHER WHICH IS
FACILITATING THE GENERATION AND
USE OF DATA INCLUDING EXISTING
CLINICAL DATA FOR SECONDARY
ANALYSIS.
IT'S THIS STRUCTURE THAT IS DONE
FOR WHICH THE HEAL FUNDS HAVE
ENABLED US TO HAVE THE RESOURCES
CAPABILITY TO MAKE THIS
POSSIBLE.
I WANT TO END MY PRESENTATION
HERE.
AND WHAT WE DO IS CRUCIAL FOR
WHAT WE DO WITH PAIN AND WHAT WE
DO WITH PAIN IS CRUCIAL FOR WHAT
WE DO WITH OPIOID USE DISORDER
AND OVERDOSES.
YOU HEARD ME SAY AND I'M GOING
TO REPEAT IT, IF WE DO NOT
PROVIDE ALTERNATIVE TREATMENTS
FOR PEOPLE WITH SEVERE PAIN
THEY'LL GO OUT IN THE ELICIT
MARKET TO GET RELIEF AND PUT
THEM AT EXTREMELY HIGH RISK OF
OVERDOSES.
AS INCREASINGLY MORE POTENT
SYNTHETIC DRUGS ARE BECOMING
MORE AVAILABLE AND WIDESPREAD.
I WANT TO THANK YOU FOR YOUR
ATTENTION AND TURN THE
MICROPHONE TO MY ESTEEMED
COLLEAGUE, DR. KOROSHETZ WHO
CO-LEADS THE HEAL INITIATIVE.
WALTER.
>> Dr. Koroshetz: IT'S
REFRESHING TO SEE THE REDUCTION
IN OVERDOSE DEATHS.
YOU CAN'T BEAT THAT.
THAT'S FANTASTIC.
I'LL SPEAK ON BEHALF OF THE PAIN
I.C. DIRECTORS.
I THINK WE HAVE 14 I.C.
DIRECTORS IN THE HEAL PAIN GROUP
AND THE CO-CHAIR HELEN LANGEVIN
AND DR. CRISWELL.
I WISH I HAD BETTER NEWS THAT
NORA TALKED ABOUT AND IN TERMS
OF THE PAIN DATA IT PLAY BE
DIFFICULT IN HOW THINGS WERE
ASCERTAINED THROUGH THE YEARS
AND ADULTS EXPERIENCE PAIN MOST
DAYS WHICH IS AN INDICATOR OF A
PROBLEM.
[NO AUDIO]
IT'S MORE EFFECTIVE IN TERMS OF
PREVALENCE OF EXPERIENCING PAIN
EVERY DAY.
AND PAIN RESTRICTS LIFE/WORK
ACTIVITIES FROM 7.4% TO 8.5% OF
ADULTS AND THE PROJECT WE HAVE
FOCUSSING ON AMERICAN INDIAN AND
NATIVE AMERICANS AND THOSE
GROUPS ARE MORE LIKELY TO HAVE
THE AFFECT OF PAIN THAN ANY
OTHER GROUP.
RURAL AREAS ARE MOST IMPACTED
AND DEALING WITH HIGH IMPACT
CHRONIC PAIN.
OLDER ADULTS THAT CAN'T GET AWAY
WITH THINGS THEY USED TO GET
AWAY WITH AND PAIN IS MUCH MORE
OF A PROBLEM AS OUR POPULATION
AGES.
IN THE AGES POPULATIONS
COMORBIDITIES ONE STARTS TO
ACQUIRE THOSE AND THAT
COMPLICATES THINGS.
AGAIN YOU RUN INTO A LITTLE BIT
OF A CHICKEN AND EGG PROBLEM
WHERE PAIN ITSELF LEADS TO
CHRONIC ILLNESSES WHETHER IT'S
OPIOID ABUSE OR ANALGESIC OR
DRUG ABUSE OR SEDENTARY
LIFESTYLE AGGREGATE THESE
CHRONIC MEDICAL PROBLEMS AND
THEY ALSO AGGREGATE PAIN
CONDITIONS.
THERE'S DEFINITELY FEEDBACK
CYCLE THERE I SAID THIS BEFORE,
AT SOME POINT WE'LL HAVE TO DEAL
WITH THIS ISSUE.
CLEARLY MOST INVESTIGATORS WOULD
LIKE TO STAY AWAY FROM THIS
BECAUSE IT MAKES THINGS REALLY
COMPLICATED WHEN YOU BRING UP
COMORBIDITIES.
IT'S KIND OF A GLARING PROBLEM
OUT THERE THAT WOULD BE GREAT IF
WE TRY TO MAKE HEADWAY.
A COUPLE THINGS ABOUT GOING OVER
HOW HEAL'S ADDRESSING PAIN AND
WE'VE SEEN THIS SLIDE BEFORE.
THE KEY THING TO POINT OUT HERE
IS WE'RE TRYING TO TAKE
ADVANTAGE OF ALL THE PAIN
RESEARCH ACROSS ALL THE
INSTITUTES AT NIH ON DISCOVERING
PAIN MECHANISMS OR
CHARACTERISTICS OF PAIN IN
CERTAIN POPULATIONS BUT THEN
TAKING THAT INFORMATION AND
FUNDING WORK THAT WILL GET TO
TREATMENTS, BETTER TREATMENTS
FOR PAIN.
BETTER NON ADDICTIVE TREATMENTS
FOR PAIN.
SO WE START ON THE LEFT.
WE DON'T DO A LOT OF THE BASIC
DISCOVERY RESEARCH BUT WE DO DO
WHAT'S CALLED TARGET VALIDATION
AND TARGET DISCOVERY WHICH IS
ONCE YOU MAKE A DISCOVERY IN THE
LAB THE QUESTION IS IS IT REALLY
SOMETHING THAT'S DRUGGABLE OR
GOING TO WORK AND THAT TAKES
REALLY SOME KIND OF BRUTE FORCE
WORKS.
OFTEN TIME NOT REALLY ATTRACTIVE
IN AN RO1 APPLICATION AND ANIMAL
MODEL DEVELOPMENT APPLICATION
CRITICAL IN TRYING TO MOVE PAIN
THERAPIES TOWARDS PEOPLE AND GET
AWAY FROM THE MISTRUST THAT
COMPANIES HAVE WITH REGARD TO
ANIMAL MODELS BECAUSE THEY ARE
HAVE POORLY PREDICTED WHAT
HAPPENS IN THE HUMAN AND HOW TO
IMPROVE ON THAT.
THAT'S NOTHING THAT DIDN'T WORK
IN THE HUMAN THAT DIDN'T WORK IN
THE ANIMAL.
WE'RE STUCK IN THAT SPACE AND
TRYING TO MOVE THINGS FORWARD.
THERE MIGHT BE SOME CHANCES OF
JUMPING OVER INTO HUMAN PAIN.
AND FOCUSSED ON LOOKING AT
SIGNATURES OF PAIN IN HUMAN
TISSUES.
BYPASS AND LOOKING AT ABOUT WHAT
THEY USED TO DO AND LOOK AT
HUMAN SPINAL CORD RELATED TO
PAIN AND AND WE HAVE A
PRESCREENING PLATFORM PEOPLE CAN
TEST THEIR ASSETS ON MULTIPLE
ANIMAL PAIN ASSAYS.
THESE ARE VERY RIGOROUS AND
REGULARIZED.
WHETHER IT'S ACADEMIC OR BIO
TECH CAN BE SURE HOW THE DRUG
STANDS IN RELATIONSHIP TO THESE
MANY DIFFERENT MODELS.
AND THEN NCATS HAS BEEN VERY
ACTIVE IN USING THEIR RESOURCES
TO DEVELOP NEW TARGETS WITH
TISSUE CHIP TECHNOLOGIES AND THE
REJOIN PROGRAM IS ONE THAT IS A
PROGRAM LOOKING AT THE
INNOVATION OF THE ENTIRE JOINT
SO NOT JUST I THINK THE
LIGAMENTS AND MUSCLES --
SOMETHING THAT COMPRISES THE
WHOLE JOINT AND A MULTI I.C.
PROJECT WOULD BE HELPFUL.
MORE BASIC PROJECTS NOT AN
INITIAL I.C. CAN DO IT SELF.
WE HAVE A NUMBER OF THERAPEUTIC
DEVELOPMENT PROJECTS FOR BOTH
BIOLOGICS, SMALL MOLECULES,
DEVICES.
THE HOPE WOULD BE WE GET
BIOMARKERS FOR PAIN THAT WOULD
HELP IN TESTING PHASE II TESTING
OF ASSETS AND THEN ONE THING TO
NOTE IS THE BASIC SCIENCE OF
PAIN IS REALLY EXPLODED.
IT'S NOT THAT WE DON'T HAVE
TARGETS BUT THE ISSUE IS HOW YOU
EFFICIENTLY IDENTIFY TARGETS
THAT ARE GOING TO BE ACTIONABLE
AND DRUGGABLE IN A PHASE II
TRIAL.
FOR THAT WE NEED THE BIOMARKERS
BECAUSE OF THE GREAT VARIATION
IN SUBJECTIVE RESPONSES ABOUT
PAIN.
THEN WE HAVE ANOTHER PROJECT
LOOKING AT BACK PAIN TRYING TO
GET AGAIN THE BIOMARKERS FOR THE
DIFFERENT TYPES OF CONDITIONS
THAT CAUSE BACK PAIN AND
UNDERSTANDING WHICH ARE THE BEST
TREATMENTS FOR THESE DIFFERENT
TYPES OF BACK PAIN.
OF COURSE BACK AND NECK PAIN
BEING THE MAJOR COURSE OF
DISABILITY IN THE UNITED STATES.
SO A REALLY IMPORTANT PROJECT TO
MOVE FORWARD.
WE HAVE MAJOR EFFORTS TO TRY AND
BUILD THE WORKFORCE IN PAIN
SIMPLY ON THE CLINICAL SIDE.
THE BAD NEWS THIS WEEK THE
PURPOSE NETWORK WAS CANCELED AND
WE'RE STILL TRYING TO WORK THAT
THROUGH.
WE'RE TRYING TO DO EVERYTHING WE
CAN TO DEVELOP A BETTER
WORKFORCE IN THE CLINICAL PAIN
SPACE AND THE DATA ECO SYSTEM IS
A VERY INNOVATIVE ONE AND DATA
FROM ALL THE HEAL PROGRAMS CAN
BE INTEGRATED INTO A SINGLE
PORTAL AND SO WANTED TO COMPARE
ACROSS STUDIES BUT THE DATA HAS
WORKED SO IT'S COMPARABLE, WHICH
IS A MAJOR LIFT.
WE HAVE A NUMBER OF CLINICAL
TRIALS PROGRAMS GOING ON IN
RURAL PAIN IN HEALTH CARE
SYSTEMS AND PEOPLE ON DIALYSIS.
PRAGMATIC TRIALS IN HEALTH CARE
SYSTEMS AND RESEARCH LOOKING AT
AS WE MENTIONED THE DIFFERENT
DEMOGRAPHIC GROUPS THAT SUFFER
MOST GREATLY FROM PAIN AND MAY
REQUIRE SPECIAL TENSION AND HAVE
PROGRAMS TO REDUCE THE PAIN.
AS NORA MENTIONED THIS
INTEGRATION BETWEEN
UNDERSTANDING HOW FAST TO TREAT
PAIN WHILE REDUCING RISK OF
ADDICTION AND A SO VERY
CHALLENGING PROBLEMS.
PEOPLE WHO HAVE AN OPIOID USE
DISORDER BUT ALSO HAVE PAIN,
WHICH IS THE MAJORITY.
HOW ARE THOSE PEOPLE MANAGING.
OF COURSE YOU CAN EASILY
UNDERSTAND IF THAT'S NOT MANAGED
WELL, TRYING TO TREAT THE OVER
USE DISORDER YOU MAKE THE PAIN
WORSE AND TRYING TO TREAT THE
PAIN YOU MAKE THE DISORDER
WORSE.
THEY'RE TIED TOGETHER AND THE
HEAL INITIATIVE IS IMPORTANT
THIS PARTICULAR GROUP PAY
ATTENTION.
OKAY, THAT'S WHAT WE'VE DONE SO
FAR.
WHAT WE'RE GOING TO DO IN THE
FUTURE YOU'RE GOING TO HEAR FROM
THE RECOMMENDATIONS THAT THE
WORKING GROUP OF COUNCIL PUT
TOGETHER AND ROB AND KATHLEEN
WILL TALK ABOUT THE PAIN
RESEARCH PRIORITIES THAT CAME
OUT OF THE WORK THEY'VE DONE IN
THE LAST YEAR AND THANKS TO
JACKIE WARD FOR ORGANIZING THESE
FOLKS.
IT'S A PRETTY NICE GROUP.
I DON'T THINK JACKIE WAS SUCH A
HEAVY LIFT.
THESE ARE EASY FOLKS TO WORK
WITH.
NOT LIKE SOME OF OUR OTHER
GROUPS.
CERTAINLY SOME MORE TALK AND
MENTION ABOUT THE PROGRESS WITH
REGARD TO THE EARN NETWORK.
YOU CAN SEE HERE THE PROJECTS
ENROLLMENT IS COMPLETED.
A COUPLE WHERE THERE'S ACTUALLY
A PUBLICATION BUT MOST OF THE
PUBLICATIONS HAVE BEEN COMING
OUT NEXT YEAR OR SO SO REALLY
INTERESTED IN LOOKING AT THOSE.
AND THIS SHOWS MOST THE PAPER IS
ABOUT THE TRIAL RATIONALE AND
DESIGN.
I WOULD SAY THE ONE IN THE
MIDDLE WHICH WAS DONE THROUGH
ONE OF THE NICHD NETWORKS LOOKED
AT AN INDIVIDUALIZED PROGRAM FOR
MANAGING PAIN IN WOMEN AFTER
HAVING A C SECTION.
WHAT THEY SHOWED COMPARED TO THE
USUAL FIXED DOSE OF OPIOIDS.
THIS INDIVIDUALIZED PROGRAM LED
TO A LOWER USE OF OPIOIDS
ACTUALLY OVER 90 DAYS THAN THE
FIXED DOSE AND THE PAIN CONTROL
WAS NOT INFERIOR SO EQUAL MAY BE
CONTROL WITH LESS USE OF DRUGS.
WE'RE LEVERAGING THE CTSAs TO
HELP WITH DEVELOPMENT AND
MANAGEMENT THE OF THE TRIALS AND
IT WILL BE BASED ON DISCUSSIONS
THAT OCCUR AFTER WE HEAR FROM
THE WORKING GROUP OF COUNCIL AND
RESEARCH RECOMMENDATIONS.
EQUALYOU PROBABLY SAW IN THE
FIRST PAPERS FOR THE FIRST TIME
IN 20 YEARS THERE'S A NEW CLASS
FOR PAIN A SODIUM CHANNEL
INHIBITOR.
NIH FOLKS HAVE BEEN DOING ALL
THE BASIC SCIENCE ON THESE
CHANNELS.
WE'VE INVESTED IN THE 1.7, WHICH
I THINK WAS DEVELOPED AND
LICENS
LICENSED WITH VERTEX AND THEY
CAME OUT WITH THE INHIBITER
SHOWN IN THE ACUTE PAIN MODELS
TO BE EQUIVALENT TO OPIOID
MEDICATIONS COMMONLY USED AFTER
THE SURGERIES.
WE'RE SEEING A BREAKTHROUGH AND
HOPEFULLY THE DOOR IS OPEN AND
THERE'LL BE MORE OF THE
NON-ADDICTIVE DRUGS COME
THROUGH.
AND ANOTHER INTERESTING PAPER
CAME OUT LOOKING AT THE
CANNABINOID 1 RECEPTOR.
THE RECEPTOR IS PRESENT
PERIPHERALLY AS WELL AS
CENTRALLY.
WHAT THIS GROUP DID WAS TO USE
A.I. INSILICO TECHNIQUES TO
DERIVE MOLECULES THAT DON'T GET
INTO THE CENTRAL NERVOUS SYSTEM
SO THEY'RE PRIMARILY PERIPHERAL
AND THEY DO NOT ACT THROUGH THE
ARRESTIN PATHWAY WHICH LEADS TO
TOLERANCE OVER TIME.
AND THEN SHOWED THAT THEY
COMPARED HERE IN YELLOW IS THE
NEW COMPOUND GENERATED NOR GROUP
AND GREEN IS THE NON SPECIFIC
CANNABINOID RECEPTOR.
AND A GLYCERIN MODEL ON THE
RIGHT.
IT'S NOT A DRUG YET BUT KIND OF
OPENS UP A PATHWAY OF ACTING ON
THE CANNABINOID RECEPTOR
PERIPHERALLY ONLY.
YOU DON'T GET THE CNS EFFECTS
FOR PAIN.
IN TERMS OF THE BIOMARKER SPACE
IS TOUGH GOING.
TO HAVE A MARKER BETTER THAN
THAN A PAIN SCORE WOULD PREDICT
WHO WILL HIGH INTENSITY PAIN
VERSUS LOW INTENSE
I PAIN AFTER AN INSULT WOULD BE
FANTASTIC AND TRYING TO DESIGN
CLINICAL TRIALS.
I GUESS THERE'S BEEN LITERATURE
LOOKED AT BY THIS GROUP FROM
UNIVERSITY OF MARYLAND
PARTNERING WITH EXPERIMENTALISTS
IN AUSTRALIA.
AND THEY'RE TRYING TO IDENTIFY A
BIOMARKER WHO DEVELOPS SEVERE
VERSUS THOSE WHO DON'T.
GOOD RESULTS LOOKING AT THE PEAK
ALPHA FREQUENCY ON THE
SENSORIMOTOR EG LEADS.
BASICALLY WHAT YOU SEE IS THAT
THE BLUE WHICH IS THE -- I GET
THIS WRONG EVERY TIME.
THE PEOPLE PREDICTED HIGH PAIN
HA
HAVE A SLOWER FREQUENCY THAN THE
PEOPLE WITH HIGH PAIN HAVE A
LOWER FREQUENCY THAN THE PEOPLE
THAT GO ON TO DEVELOP HIGH PAIN.
AND THEY ALSO LOOK AT WHAT'S
CALLED CORTICAL MOTOR
ACCELERATION.
WHAT YOU SEE IS OVER TIME IN THE
LOWER RIGHT HAND GROUP THE
PEOPLE WHO HAVE HAVE LOW PAIN --
PEOPLE WITH HIGH PAIN HAVE A
SHRINKAGE OF THE CORTICAL MOTOR
EXCITABILITY OVER TIME.
CORTICO MOTOR EXCITABILITY.
AND WITH THE CORTICO MOTOR
EXCITABILITY IT PREDICTS WHO
GOES ON TO DEVELOP HIGH
INTENSITY VERSUS LOW INTENSITY
PAIN.
SO A BIOMARKER COMING RIGHT OUT
OF EEG WHICH LOOKS LIKE -- IT
LOOKS ROBUST IN THE MODEL WHICH
IS AGAIN A CLASS MODEL SO
PROBABLY A LITTLE MORE ROBUST
THAN YOU MIGHT SEE.
AND ANOTHER REPORT TO MENTION IS
WORK BEING DONE ON THE DEVICES.
THIS ONE COULD GET DEVELOPED TO
GET MORE PRECISE STIMULATION OF
THE ROOTS THAT ARE INVOLVED IN
PAIN WITH A DEVICE AND HAS
CONTROLLERS THAT ENABLE YOU TO
REALLY GET OUT IN THE LATERAL
SURFACE AND BE PRECISE ON WHICH
ROOT YOU GO AFTER.
AND THIS IS A STUDY THAT CAME
OUT OF THE HOPE STUDY WHICH IS A
STUDY OF PATIENTS WITH DYAT
DYATHATLON DIALYSIS AND DIDN'T
SHOW SIGNIFICANT IMPACT ON THE
EXTENT TO WHICH THE PAIN
INTERFERED WITH THE PATIENT'S
LIVES.
THE AFFECT WAS MODEST BUT HAD A
VERY HIGH ACCESSIBILITY AND
TOLERABILITY AND SAFETY.
HOPEFULLY IT'S SOMETHING THAT
CAN GO INTO.
AND ANY RELIEF I'M SURE WOULD BE
APPRECIATED BY THESE FOLKS.
SO SO THOSE ARE THE REMARKS FROM
NORA AND I THAT LET PEOPLE KNOW
WHAT'S GOING ON AND WILL BE
HAPPY TO ANSWER ANY QUESTIONS
NOW.
WE REALLY HAVE TO STICK TO THE
SCIENCE.
AS THE A LOT GOING ON AT NIH.
IT'S PROBABLY BEST IF WE DON'T
GO THERE.
BUT HAPPY TO TALK ABOUT WHAT
NORA MENTIONED AND WHAT I
THOUGHT ABOUT IN REGARD TO THE
HEAL INITIATIVE.
>> Director Volkow: ANYONE THAT
HAS QUESTIONS CAN RAISE THEIR
HAND.
YES, TERRY.
YOU'RE MUTED.
>> YES, WELL I'M ACTUALLY
PUTTING IT IN THE CHAT.
I THOUGHT THIS WAS SUCH
INCREDIBLY GOOD NEWS ABOUT THE
DECREASES IN OVERDOSE DEATHS.
IT'S TERRIFIC.
OBVIOUSLY ENORMOUS WORK GOING ON
AND TREATMENT WITH REGARDS TO
NALOXONE AND IT'S CLEAR TO ME A
LOT OF THE INTERVENTIONS ARE
CLEARLY DRIVING THIS.
ARE THERE DATA THAT I KNOW THEY
COULDN'T PRESENT TODAY BUT TO
SUGGEST THE USE IS COMING DOWN?
IS THIS IS AT LEAST SOME
CONTRIBUTOR TO THE CHANGE.
WITH THE INITIATION OF USE AND
IT'S PROBABLY HARD TO GET OTHER
DATA BUT JUST CURIOUS.
>> Director Volkow: THERE ARE
SURVEYS DONE ON A YEARLY BASIS
ALLOWING ONE TO LOOK AT THE
SURVEYS WHICH ARE PRETTY YARD
LIKE ONE FROM SAMHSA WHICH IS
PEOPLE 12 YEARS OR OLDER.
AND ONE TOWARDS PEOPLE NOT
HOMELESS AND TO ASSESS WHETHER
THERE'S ANY EVIDENCE OF
REDUCTION IN SUBSTANCE USE.
WHAT I CAN TELL YOU IS THE DATA
DOES NOT SEEM TO SHOW THERE'S A
DECREASE IN SUBSTANCE USE PER SE
AND SOMETIMES USING THE
INITIATION, OPIOID USE
INITIATION.
IN ADOLESCENCE THOUGH YES, AND
WE'VE BEEN SEEING FOR MANY
YEARS.
IT'S NOT CONSISTENT IN ANY WAY
WITH THE RISE WE WERE SEEING IN
OVERDOSES BUT WERE SEEING
DECLINE IN SUBSTANCE USE AMONG
TEENAGERS AND THAT CONTINUES TO
GO AHEAD.
IT'S NOT SO MUCH PEOPLE ARE
USING LESS SUBSTANCES.
IT'S MORE LIKELY THE SUBSTANCES
THE ELICIT DRUGS AVAILABLE ARE
LESS DANGEROUS BECAUSE THEY
HAVE -- THE FENTANYL THAT'S
COMING INTO THE COUNTRY HAS
LOWER PURITY AND HAS BECOME
HARDER TO BRING IT.
THE DEALERS DON'T SEE SO MUCH OF
AN INCENTIVE TO MIX COCAINE WITH
FENTANYL.
THAT'S ONE FACTOR THAT WILL MAKE
THE ILLICIT DRUGS AVAILABLE LESS
DANGEROUS.
ALSO THERE'S BEEN AN EDUCATION.
IN THE BEGINNING WE WERE SEEING
THE LATE '20s, BEFORE 2018
PEOPLE DIDN'T REALIZE HOW
DANGEROUS FENTANYL WAS.
I RECALL BECAUSE I WAS IN WEST
VIRGINIA AROUND IN A TOWN WITH
EXTREMELY HIGH RATES OF OVERDOSE
AND PEOPLE DIDN'T KNOW WHAT
FENTANYL WAS.
IT WAS THE CAPITAL OF OVERDOSE
DEATHS.
SO THROUGH EDUCATION AND PEOPLE
HAVE BECOME MORE MINDFUL ABOUT
THE DANGERS AND OF COURSE THAT
DID NOT STOP THE INCREASE IN THE
COVID PANDEMIC BUT WITH TIME THE
MORE YOU SEND A MESSAGE PEOPLE
ARE AWARE.
THEY'VE LEARNED THEY'VE HAD TO
TAKE THE DRUGS MORE CAREFULLY
AND THE USE OF NALOXONE HAS
INCREASED ENORMOUSLY.
IF I WERE TO PICK UP ONE I WOULD
SAY PERHAPS NALOXONE HAS BEEN
THE MOST CONSEQUENTIAL.
>> THANK YOU.
I SEE A HAND RAISED.
>> THANK YOU BOTH.
IT'S A GREAT REVIEW.
I THOUGHT IT'S WORTH
HIGHLIGHTING OR MENTION ED
CERTAINLY FOR THE PUBLIC THAT'S
LISTENING AND WHEN WALTER SPOKE
OF THE NEW PAIN RELIEVING DRUG
THAT WAS DEVELOPED AGAINST A
PARTICULAR TARGET THAT IT WAS
REALLY FUNDAMENTAL SCIENCE, PRE
CLINICAL SCIENCE EVEN IN RODENTS
THAT DEMONSTRATED WHAT'S SPECIAL
ABOUT THE TARGET THAT IT'S ONLY
FOUND IN WHAT WE CALL THE PAIN
FIBERS MAKES IT A GREAT TARGET
AND JUSTIFIED THE EXPENSE TO
COME UP WITH THE DRUG THAT
TARGETS AND I WOULD SAY I KNOW
THERE ARE OTHER COMPANIES THAT
ARE GOING AFTER THE SAME TARGET
OR RELATED TARGETS AND THE REAL
BEAUTY OF IT, IT TURNS OUT THE
TARGET IS NOT FOUND IN THE
BRAIN, WHICH INCREASES THE
LIKELIHOOD OF THAT HAVING WHAT
WE CALL A THERAPEUTIC WINDOW TO
BLOCK THE PAIN AND NOT PRODUCE
THE ADVERSE SIDE EFFECTS THAT
LIMIT SO MANY DRUGS.
THAT'S ALSO THE BEAUTY OF THE
CANNABINOID TARGET TO WHICH
WALTER MADE REFERENCE SINCE IT'S
ONLY FOUND OUTSIDE OF THE BRAIN
AND AGAIN THE HOPE IS THAT IT
WILL BE ABLE TO BLOCK PAIN AND
HAVE A BETTER THERAPEUTIC
WINDOW.
I THING THIS IS A BEAUTIFUL
EXAMPLE OF WHERE THE PRE
CLINICAL FUNDAMENT SCIENCE HAS
MADE A DIFFERENCE.
THAT'S IN DEVELOPING NOVEL
DRUGS.
>> Dr. Koroshetz: WE HAVE TO GET
THE DOSES WHERE YOU GET A BIG
AFFECT SIZE AND NOT THE SIDE
EFFECTS.
IN THE BLOOD BRAIN BARRIER COULD
BE OUR FRIEND.
USUALLY IT'S OUR ENEMY BUT HERE
IT COULD BE OUR FRIEND.
>> Director Volkow: IT'S USUALLY
OUR FRIEND, WALTER.
YOU DON'T WANT ALL THE THINGS
CIRCULATING GETTING IN OUR
BRAIN.
THE OTHER BEAUTIFUL EXAMPLE
WALTER PRESENTED ABOUT THE
CANNABINOID RECEPTOR IT'S
UNDERSTANDING THE THREE
DIMENSIONAL STRUCTURE OF THE
RECEPTOR AND THE DRUG.
IT'S THAT CHARACTERISTIC THAT
MAKES IT PERIPHERALLY
RESTRICTIVE.
THIS IS PURELY BASIC FUNDAMENTAL
SCIENCE.
SO THOSE ARE EXAMPLES OF WHY WE
CANNOT NEGLECT BASIC SCIENCE AND
WE DON'T KNOW WHERE IT'S GOING
TO GO.
CERTAINLY IT OPENS UP MANY DOORS
AND WINDOWS FOR MULTIPLE
DISEASES.
>> ROB, DID YOU HAVE YOUR HAND
UP?
>> I DID BUT NORA MADE THE POINT
OF AMPLIFYING THE BASIC POINT OF
SCIENCE YOU DON'T KNOW IF IT'S
ADVANCES IN CRYO MICROSCOPY OR
HOW PROTEINS ARE MOVING IN REAL
TAME AND WE JUST DON'T KNOW
WHERE IT'S COMING FROM.
SOMETHING WE HEARD ABOUT IN THE
STRATEGIC PLANNING PROCESSES
WHICH WE'LL TALK ABOUT.
>> Dr. Koroshetz: THAT WAS ALL
THE GOOD NEWS.
WE HAVE A MORE DIFFICULT TOPIC
TO TALK ABOUT NEXT.
>> ERIC HAS HIS HAND UP, WALTER.
>> I JUST RAISED IT.
I WAS SLOW TO THE PUNCH.
THANK YOU BOTH FOR YOUR
FANTASTIC PRESENTATIONS AND
THESE NEW DATA THAT ARE SO
ENCOURAGING ABOUT THE MASSIVE
DECLINE IN OVERDOSE DEATHS.
OBVIOUSLY WE'RE MAKING GREAT
PROGRESS AND I REALLY FEEL LIKE
THE FUNDING AND THE RIGOROUS
SCIENCE THAT'S BEEN PUSHED BY
THE NIH HEAL INITIATIVE HAS BEEN
PAYING OFF IN TERMS OF SAVING
LIVES SO I THINK WE CAN ALL FEEL
REALLY GOOD ABOUT THAT.
MY QUESTION TO YOU IS BASED ON
YOUR HIGH LEVEL VIEW, NORA, TO
WHAT EXTENT IS ACCESS TO
EVIDENCE-BASED TREATMENT FOR
ADDICTION STILL A PRESSING NEED
FOR SOCIETY?
>> YES, I THINK NORMALLY
DEPENDING ON WHAT AREA OF THE
COUNTRY YOU ARE AT AND AS I
MENTIONED CLEARLY IN RURAL AREAS
THIS IS A MAJOR DEFICIT BUT SOME
OF THE URBAN AREAS ACCESS TO
TREATMENT IS STILL VERY LIMITED.
SO AS A RESULT OF THAT AND WE
ARE TARGETING -- WE'RE THINKING
STRATEGICALLY HOW TO ACTUALLY
TARGET THOSE AREAS AND WE
HAVE -- WE'RE DOING AN
ANALYSIS -- THERE WAS A RECENT
ANALYSIS DONE THAT LOOKED AT THE
COMMUNITIES ACROSS THE UNITED
STATES TO GET A SENSE OF THE
LEVEL OF INVESTMENT ON HEALTH
CARE NEEDS AND HOW WHAT THEY
FOUND WAS TREMENDOUS DIVERSITY
ACROSS THE UNITED STATES WITH
SOME COUNTIES PUTTING MORE MONEY
THAN OTHERS AND SOME PUTTING
MORE FOR A PARTICULAR AREA OF
MEDICINE AND NOT THE OTHER.
WE'RE TRYING TO DO SOMETHING
SIMILAR FOR THE SUBSTANCE USE
DISORDER SPACE TO GET AN
UNDERSTANDING NOT JUST AS WE
KNOW THERE IS A DEFICIT BUT WHAT
ARE THE CHARACTERISTICS OF THOSE
DEFICITS AND AT THE SAME TIME,
WHAT ARE THE CHARACTERISTICS OF
THOSE COMMUNITIES?
ONE CAN GET FLEXIBLE TAILORED
INTERVENTIONS TO BE TARGETED
BASED ON THE CONTEXT AND
CONDITION.
WE ARE TRYING TO NOW EXPAND WITH
GREATER UNDERSTANDING THE DATA
THAT CAN HELP US IDENTIFY THE
SPECIFICS OF THE NEED BECAUSE
THE NEED IS OUT THERE,
ABSOLUTELY, BUT NOT EQUAL ACROSS
THE COUNTRY SO HOW DO YOU TARGET
THAT?
>> THANK YOU.
VERY IMPORTANT.
>> Director Volkow: I DON'T HEAR
YOU, WALTER.
>> Dr. Koroshetz: OKAY, SO OUR
NEXT TOPIC ACTUALLY IS WITH
REGARD TO THE MDWG.
SO DEF
SO, THIS GROUP HAS BEEN AMAZING
OVER THE YEARS.
A LOT HAS BEEN THROUGH YOUR
CONTRIBUTIONS.
WE THINK IT'S PROBABLY TIME TO
GO THROUGH AND RECONSTITUTE THE
MDWG OVER TIME WITH SIMILAR
EXPERTISE MAYBE NEW FOLKS AND
GIVE NEW FOLKS A CHANCE TO COME
IN AND ALSO GIVE YOU GUYS A
BREAK FOR A WHILE BEFORE WE CALL
ON YOU AGAIN.
WE KNOW WHERE YOU LIVE.
WE KNOW YOUR E-MAILS SO WE WILL
BE CALLING BUT WE THOUGHT IT'S
PROBABLY THE RIGHT TIME TO DO
IT.
WE'RE NOT HAPPY ABOUT IT BECAUSE
WE REALLY LIKE YOU GUYS BUT
THINK IT WAS THE RIGHT THING TO
DO.
>> Director Volkow: I WAS GOING
TO COMMENT, WALTER, WE DO THIS
FOR OUR COUNCILS AND OTHER
GROUPS THAT WE ROTATE THE
MEMBERS TO GET DIFFERENT
PERSPECTIVES.
FIRST OF ALL, WE'RE VERY
GRATEFUL FOR ALL THE WORK YOU'VE
DONE AND RECOGNIZE YOU HAVE A
UNIQUE PERSPECTIVE AND IT'S MADE
HEAL MUCH BETTER.
THE FACT WE'RE GOING TO GO INTO
A PROCESS OF ACTUALLY GETTING
NEW MEMBERS DOES NOT IN ANY WAY
INDICATE THAT WE'RE NOT GOING TO
BE RELYING ON YOU FOR OTHER
TASKS.
BUT FOR THE MULTI-DISCIPLINARY
GROUP LIKE WHAT WE DO WITH OTHER
GROUPS IS ROTATE THE MEMBERS AND
REFLECT THE FACT WE ARE NOT VERY
IMPRESSED AND PLEASED WITH YOUR
INVOLVEMENT.
IN FACT WE'RE BOTH VERY GRATE.
.
AND WE'LL MISS YOU AS PART OF
THE MULTI-DISCIPLINARY GROUP.
YES, WE KNOW YOUR E-MAILS AND
WE'LL BE SEEING YOU AND RELYING
ON YOU TO ACTUALLY KEEP US
ACCOUNTABLE.
THAT IS PART OF YOUR JOB WHETHER
YOU'RE PART OF THE
MULTI-DISCIPLINARY GROUP OR NOT
AND YOU REACH OUT TO US FOR
SUGGESTIONS.
WALTER, YOU HAD BASICALLY A
PROCESS BY WHICH WE'RE GOING TO
BE DOING THESE.
YOU WANT TO GO OVER IT?
>> Dr. Koroshetz: SO I JUST WANT
TO SAY, NORA SAID FOR COUNCIL
IT'S EVERY FOUR YEARS, SAME
THING I THINK YOU GUYS HAVE BEEN
SIX, SEVEN YEARS SOME OF YOU.
AND THAT'S BECAUSE YEAH IT'S
BEEN WORKING SO WELL.
WE WEREN'T FORCED BUT THINK IT'S
THE RIGHT THING TO DO AND TO
ROTATE SIX OR SEVEN MEMBERS.
WE HAVE 14 MEMBERS AND ROTATE
SIX OR SEVEN OFF FOR THE NEXT
MEETING AND THEN GET SIX OR
SEVEN AND IN AUGUST AND THEN
ROTATE NEW PEOPLE ON.
THAT'S WHAT WE'RE WORKING ON.
WE'LL BRING IN NEW MEMBERS AND
ONE COHORT WILL PROBABLY ON FOR
TWO AND A HALF YEARS AND THEN
ROTATE OFF BECAUSE WE WANT TO
GET AWAY FROM A SYSTEM WHERE
EVERYBODY ROTATES AT THE SAME
TIME WHICH IS WHAT WE GOT
OURSELVES INTO HERE.
THE FIRST WILL BE ON 2.5 YEARS
AND THE NEXT GROUP ON FOUR YEARS
AND THEN ROTATION OF NEW PEOPLE
EVERY FEW YEARS OR SO.
WE THINK WE HAD A GOOD SPREAD OF
EXPERTISE HERE.
WHAT WE'D LIKE YOU TO DO, IF
YOU'RE WILLING, IS TO TRY TO
THINK OF PEOPLE LIKE YOU OR
SIMILAR IN TERM OF EXPERTISE
THAT YOU WOULD SUGGEST WOULD BE
GOOD PEOPLE TO THINK ABOUT FOR
THE REPLACEMENT GROUPS COMING
IN.
WE'RE HOPING A PLAN WOULD BE TO
HAVE AT LEAST ONE NUMBER AN
NINDS COUNCIL MEMBER AND ONE
NIDA MEMBER LINKING MDWG TO
COUNCIL.
IT'S AN UNOFFICIAL WORKING GROUP
OF COUNCILS.
WE DEFINITELY NEED AT LEAST ONE
MEMBER POTENTIALLY MORE OF
PEOPLE WHO HAVE HAD LIVED
EXPERIENCE IN EITHER PAIN OR
OPIOID USE DISORDER OR A
COMBINATION.
I THINK FOR SOME COMMITTEES AND
AT NIH YOU CAN'T BE ON ANOTHER
STUDY SECTION.
FOR US I DON'T THINK IT THE
MATTER SO SERVICE ON AN NIH
FACULTY COMMITTEE IS NOT AN
EXCLUSION BUT NOT REQUIRED
EITHER.
SO WE HAVE A LITTLE BIT OF A
TIME PLANNED FOR DOING THIS
STUFF AND HAVE WIDE SOLICITATION
PROBABLY STARTING NEXT MONTH.
THEN TRYING TO DEVELOP A SLATE
SOME TIME IN APRIL, LATE APRIL
AND THEN SEE WHO WE CAN CAJOLE
TO COME IN.
AND WHAT'S OFTEN VERY HELPFUL
PEOPLE DON'T KNOW EXACTLY WHAT
IT'S LIKE BUT ANYBODY ON THIS
GROUP WOULD BE WILLING TO TALK
TO PEOPLE THINKING ABOUT COMING
ON, I THINK THAT WOULD BE
HELPFUL SO THEY KNOW WHAT
THEY'RE GETTING INTO AND ALSO
KNOW HOW GOOD A GROUP IT'S BEEN.
SO THAT'S KIND OF OUR PLAN FOR
NOW.
IF THERE ARE PEOPLE WILLING TO
COME OFF IN THE FIRST GROUP,
PLEASE LET US KNOW AND EVERYONE
IF YOU CAN THINK ABOUT THAT.
>> OUR NEXT MEETING IS APRIL 29
AND STILL KEEP THE CURRENT
MEMBERSHIP FOR THAT AND START
ROTATING IN AUGUST, WHICH IS TWO
MEETINGS FROM NOW.
>> Dr. Koroshetz: TWO MEETINGS.
OKAY.
ALL RIGHT --
>> CAN YOU HEAR ME?
JUST WANTED TO THANK YOU BOTH
FOR YOUR UPDATE.
ALL THE TREMENDOUS PROGRESS THAT
YOU'RE MAKING AND FOR YOUR KIND
WORDS ABOUT OUR SERVICE ON THE
GROUP.
I THINK THIS IS -- NO ONE WOULD
SAY THIS IS THE WRONG MOVE.
WE CLEARLY NEED TO HEAR FROM A
WIDER MORE DIVERSE GROUP OF
PEOPLE AND GIVE PEOPLE
OPPORTUNITIES TO ROTATE ON AND
OFF.
I JUST DID HAVE A QUESTION ABOUT
THE LIVED EXPERIENCE
PERSPECTIVE.
I KNOW THAT BOTH INSTITUTES
WITH THE GENERATION OF HEAL 2.0
WITH LIVED EXPERIENCE PANELS
INDIVIDUALLY.
JUST CURIOUS WHERE THAT STANDS.
ALSO, SIMILARLY TO HAVING OUR
REPRESENTATIVE FOR EACH OF THE
COUNCILS ON THIS MDWG IT WOULD
MAKE SENSE IF THE GROUPS ARE IN
PLACE YOU HAVE A LIVED
EXPERIENCE LIAISON FROM THOSE
TWO GROUPS ALSO REPRESENTED ON
THE MDWG.
IT'S CERTAINLY BEEN MY PRIVILEGE
TO BE THE LIVED EXPERIENCE
PERSON ON THE GROUP BUT I DON'T
HAVE ANY EXPERIENCE WITH OUD OR
OVERDOSE.
SO I THINK THAT PERSPECTIVE HAS
BEEN MISSING ON THE MDWG BUT I
WAS JUST CURIOUS WHERE THE
DEVELOPMENT OF THAT STANDS WITH
BOTH INSTITUTES AND WHETHER
YOU'VE HAD ANY CONSIDERATION OF
HAVING THERE BE A LIAISON TO THE
MDWG.
>> Director Volkow: IS THAT
OKAY, WALTER IF I START GIVING A
DESCRIPTION OF WHAT WE'VE DONE?
BECAUSE THIS IS A SPACE WE HAVE
BEEN WORKING ON BEFORE THE HEAL
INITIATIVE.
SO THERE IS A GROUP AT IS THE
CLINICAL TRIAL NETWORK AND THE
JCOM JUSTICE COMMUNITY
INNOVATION NETWORK AS WELL AS
THOSE PEOPLE WHO HAVE BEEN
INCARCERATED.
IT'S BEEN PLANNED FOR THE
NETWORK OF RECOVERY.
WHAT WE'VE DONE IS CREATE A
GROUP FOR THE COUNCIL WITH
PEOPLE WITH EXPERIENCES
REPORTING TO OUR COUNCIL.
ONE OF THE COUNCIL MEMBERS WILL
BE A PERMANENT INDIVIDUAL WITH A
LIVED EXPERIENCE.
AND I THINK IT'S A GOOD
SUGGESTION AND ABSOLUTELY OPEN
TO IT.
>> Dr. Koroshetz: I THINK WE'RE
THINKING SOMETHING ON THE PAIN
SIDE.
IS IT SOMEWHAT DERAILED BY
WHAT'S HAPPENING IN THE LAST
COUPLE MONTHS.
THE PLAN WAS TO REACH OUT TO
PEOPLE INVOLVED IN THE RESEARCH
PROJEC
PROJECTS AND THE TRIALS AND BE A
GROUP IN AND OF THEMSELVES AND
HAVE REPRESENTATIVES TO THE MDWG
AND MDWG THEN TO THE COUNCIL.
NOW WE HAVE THOUSANDS.
I'D LIKE TO ORGANIZE IT SO THE
GROUP IS EFFECTIVE AT ADVISING
THE ONGOING TRIALS.
LINKING THEM TO THE ACTUAL
TRIALS IS THE BEST WAY.
AND WE ROSE TO HAVE THE SKILL
SET THAT WOULD BE VALUABLE.
BUT MAYBE MORE IMPORTANTLY I
THOUGHT GOING FORWARD WE WOULD
MANDATE THAT PEOPLE DOING THE
TRIALS WOULD HIRE FOLKS WHO THEY
HAD EXPERIENCE WITH IN PREVIOUS
TRIALS WHO COULD HELP THEM IN
THE ACTUAL DESIGN AS WELL AS THE
OPERATION OF THE TRIAL.
I WAS HOPING TO GET PEOPLE WITH
LIVED EXPERIENCE FROM THE GROUND
UP AND INTEGRATE THEM IN ALL
DIFFERENT LEVELS UP TO THE
LEADERSHIP LEVEL.
ONCE WE GET THINGS GOING AGAIN
WE CAN START WORKING ON THAT
AGAIN.
>> THE ONLY OTHER THING --
SORRY, GO AHEAD.
>> NOTHING ELSE FROM ME.
GO AHEAD.
>> SORRY.
I WAS GOING TO ADD I THINK
THAT'S GREAT.
I'D PUT A MAJOR PLUG IN FOR
DOING SOME SORT OF EDUCATION AND
TRAINING OF THE FOLKS WITH LIVED
EXPERIENCE BEFORE THEY COME ON
AND DIFFICULT FOR SOMEONE TO
HAVE A GRASP ON ALL OF HEAL.
I CAN BE HELPFUL IN THE TOPICS
AND I KNOW YOU HAVE A GREAT
INTERNAL TEAM BUT IF I CAN BE
HELPFUL, LET ME KNOW.
>> Dr. Koroshetz: THAT'D BE
GREAT.
YOU'RE ABSOLUTELY RIGHT.
IT'S A VERY DIFFERENT WORLD TO
COME INTO.
WE HAVE PEOPLE WHO I THINK WILL
BE ABLE TO DO IT.
IT HAS TO BE THE RIGHT PERSON.
>> Director Volkow: I THINK JUST
LIKE YOU'RE POINTING OUT WALTER,
TO BE DEMONSTRATIVE BECAUSE SO
MANY WOULD HAVE THE LIVED
EXPERIENCE AND WHAT HAVING A
SPECIFIC GOAL ALSO IN THE
SELECTION PROCESS WOULD BE VERY
VERY HELPFUL AND CERTAINLY
WALTER IS SPEAKING ABOUT SOMEONE
THAT HAS EXPERIENCE THEMSELVES
SOME PARTICIPATING AND CLINICAL
TRIALS.
WE HAVE BEEN APPROACHED BY
PEOPLE, HAVE BEEN APPROACHED BY
PEOPLE WHO HAD AN SUBSTANCE AND
OPIOID USE DISORDER AND HAVE
EXPERIENCE WITH RESEARCH AND
WANT TO BE ACTIVELY INVOLVED
WITH IT.
I THINK THERE ARE VERY DIFFERENT
WAYS IN WHICH TO LOOK AT WHAT
THEY CAN BRING THAT IS VERY
UNIQUE IN MANY SPACES.
SO THAT KNOWLEDGE OF HAVING BEEN
DOING IT NOW MANY YEARS AND ALL
YOUR INPUT IN TERMS OF HAVING
THE MULTI-DISCIPLINARY GROUP
HAVING AN OPPORTUNITY TO GET
EXPOSED TO OTHER AREAS, FOR
EXAMPLE IN THE FIELD OF OPIOID
USE DISORDER AND PAIN.
WE'LL BE ADVANCING AND EVOLVE
WE'RE TAKING ADVANTAGE OF THE
UNIQUENESS AND HAVE PEOPLE WHO
HAVE THE CONDITION THAT THOUGHT
ABOUT IT AND HAVE LIVED THE
CONSEQUENCES.
I DON'T SEE ANYMORE HANDS
RAISED.
>> I THINK WE CAN MOVE TO A
BREAK.
WE WERE ORIGINALLY SCHEDULED TO
BE ON BREAK UNTIL 3:00 -- WE'RE
ABOUT 15 MINUTES AHEAD OF
SCHEDULE.
>> SO, WHY DON'T WE PLAN TO
RECONVENE AT 2:45.
ABOUT 15 MINUTES TO REGROUP AND
WE LOOK FORWARD TO SEEING
EVERYBODY IN ABOUT 17 MINUTES.
THANK YOU SO MUCH.
WELCOME BACK
FOLKS.
WE TALKED ABOUT ROTATING OFF AND
I HAVE ANOTHER PERSON TO TALK
ABOUT, LINDA PORTER BUT WE'RE
NOT ROTATING HER OFF, SHE'S
ROTATING US OFF.
SHE'S BEEN PLANNING TO RETIRE
AND DECIDED SHE'S ACTUALLY GOING
TO DO IT.
THAT'S BEEN A TREMENDOUS LOSS.
SHE'S BEEN A LEAD HERE AT NIH
SINCE 2003 AND SO MANY THINGS
HAVE HAPPENED SINCE THEN.
GOOD THINGS FOR PAIN RESEARCH
AND LINDA PUT TOGETHER THE PAIN
CONSORTIUM AND WORKED WITH PAIN
STRATEGY AND GOT THE INSTITUTES
COORDINATED.
GOT US ALL TO SEE EXACTLY WHAT
WE'RE FUNDING IN PAIN RESEARCH
AND HAS BEEN A GREAT AMBASSADOR
TO ALL THE SCIENTISTS AND STO
THE PATIENTS WHO SUFFER WITH
PAIN AND THE HEAL INITIATIVE.
GIST TREMENDOUS OPPORTUNITY THAT
FELL RIGHT INTO HER HANDS
BECAUSE SHE WAS PREPARED AND WAS
ABLE TO SHEPHERD THE HEAL
INITIATIVE TO WHERE IT IS NOW.
WE'RE GOING TO MISS HER A LOT
WE'RE NOT GOING TO BE ABLE TO
REPLACE HERE.
WE'LL BE TAKING OVER BEING
CLINICAL PERSON HERE AT NINDS
FOR THE CLINICAL PAIN RESEARCH
WE THROUGH HEAL.
I JUST WANTED TO CONGRATULATE
LINDA FOR ALL THE WORK SHE'S
DONE.
AND LET PEOPLE KNOW IT'S A TIME
TO REFLECT ON WHERE WE'RE COME
IN 21 YEARS.
NOT TOO SHABBY.
THANKS, LINDA.
SPEF SPEF
>> Linda: IT'S BEEN A PLEASURE
AND HONOR.
>> WE'LL TAKE A MINUTE AND PIVOT
TOWARDS THE DISCUSSION OF WHAT
MIGHT SOME RESEARCH PRIORITIES
BE.
TO THAT END I WANT TO INTRODUCE
THE DISCUSSION OF THE HEAL PAIN
STRATEGIC RESEARCH PRIORITIES.
I'M GOING TO HAND IT OVER TO
JACKIE WARD, SENIOR ADVISER FOR
THE HEAL INITIATIVE AT NINDS WHO
HAS BEEN WORKING WITH LINDA THE
LAST COUPLE YEAR AND SERVED AS
THE FEDERAL OFFICIAL FOR THE
WORKING GROUP WHO DEVELOPED THE
STRATEGIES AND DESCRIBE WHAT'S
BEEN IN STORE FOR ALL OF US.
>> Jackie: THANK YOU YOU,
LINDA.
I'LL START WITH SOME SLIDES BUT
BEFORE I GET THERE, I HAVE THE
GREAT HONOR AS WALTER MENTIONED
THE CO-CHAIRS FOR THE EFFORT.
ONE OF WHOM THIS GROUP KNOWS BUT
I'M NOT GOING TO GIVE HIM SHORT
SHIRT FOR THE VIEWING AUDIENCE.
AND THEN WE HAVE A GUEST MEMBER
I'LL START WITH ROB THE DIRECTOR
OF THE WASHINGTON UNIVERSITY
PAIN CENTER AND THE ROSE T.
BROWN PROFESSOR IN THE
DEPARTMENT OFFENCE THESIOLOGY IN
ST. LOUIS OWNED WORKING ON THE
CIRCUITS AN MOLECULAR MECHANISMS
INVOLVED IN CHRONIC PAIN
CONDITIONS WITH THE EYE TO NEW
DEVELOPMENT FOR THE MANAGEMENT
OF CHRONIC PAIN AND ITS
COMORBIDITIES.
AS THIS GROUP KNOWS HE'S A
MEMBER OF THE MDWG AND HAVING
RECEIVED AN NINDS LANDISAWARD
FOR OUTSTANDING MEMBERSHIP IN TO
2020.
KATHLEEN SLUKA IS AT THE
UNIVERSITY OF IOWA COLLEGE OF
MEDICINE WORKING ON THE
PERIPHERAL AND CENTRAL
MECHANISMS OF CHRONIC
MUSCULOSKELETAL PAIN AND
TREATMENT FOR CHRONIC PAIN.
SHE'S A P.I. ON A NUMBER OF NIH
AND HEAL AWARDS INCLUDING OF THE
CLINICAL COORDINATING CENTER FOR
THE ACUTE TO CHRONIC SIGNATURE
PROGRAM AND ON THE IOWA T32
TRAINING PROGRAM IN PAIN
RESEARCH.
SHE WAS ALSO A RECIPIENT OF THE
2024 HEAL MENTORSHIP AWARD.
SO THEY'LL DRIVE THE BULK OF THE
CONVERSATION BUT I'LL GIVE A
LITTLE BIT OF CONTEXT HERE AS TO
WHAT -- HOW WE'VE COME TO THESE
RESEARCH PRIORITIES THE PROPOSED
PRIORITIES.
CONGRESS ADDED TO SUPPORT
SUPPORT A NEW INITIATIVE ON
RESEARCH FOR OPIOID ADDICTION
AND DEVELOPMENT OF ALTERNATIVE
PAIN MANAGEMENT AND ADDICTION
TREATMENT.
SO THE EARLY DAYS ALL HAPPENED
REALLY QUICKLY AND WE WERE
GUIDED BY A NUMBER OF MEETINGS
THAT HAPPENED IN 2017.
A SERIES OF CUTTING EDGE SCIENCE
MEETING TO END THE OPIOID
CRISIS.
FORTUNATELY THANKS TO LINDA WE
HAVE THE STRATEGY AND ON THE
PAIN STRATEGY IT WAS A GUIDING
LIGHT FOR INVESTMENT AND PAIN
MANAGEMENT.
AND ALL THOSE THINGS SORT OF
WENT INTO IN FORMING THE HEAL
RESEARCH STRATEGY PUBLISHED BY
NORA, WALTER AND DR. COLLINS AT
THE TIME.
SO SET THE PRIORITIES.
THE INITIATIVE IS NOW CO-LED IN
WITH NIDA IN COLLABORATION WITH
13 OTHER INSTITUTES AND OFFICES.
SINCE 2018 THERE'S BEEN OVER
2200 RESEARCH PROJECTS IN ALL 50
STATES TOTALLING OVER $3.9
BILLION.
IT'S BEEN A VERY COLLABORATIVE
EFFORT.
WE'RE JOINED TODAY BY A NUMBER
OF THE INSTITUTE, CENTER AND
OFFICE DIRECTORS INVOLVED IN
HEAL AND PROUD TO SAY THERE'S A
NUMBER OF ACCOMPLISHMENTS.
WALTER POINTED OUT RECENT ONES
AND I'LL HIGHLIGHT SOME IN A FEW
MINUTES BUT OVER 40 FDA
APPROVALS FOR INVESTIGATIONAL
NEW DRUGS OR CLEARANCES FOR
DEVICES.
THERE'S OVER 300 CLINICAL TRIALS
UNDERWAY AND MANY OF THE INITIAL
PROJECTS LAUNCHED IN THE FIRST
COUPLE OF YEARS ARE EITHER
WRAPPING UP, HAVE WRAPPED UP
RECENTLY OR AT A TRANSITION
POINT.
THAT BRINGS US TO A
RECOMMENDATION THIS GROUP HAD
PROVIDED TO DEVELOP A STRATEGIC
PLAN TO GUIDE FUTURE HEAL
INVESTMENTS.
WE TOOK A VERY DELIBERATIVE AND
MULTI-DISCIPLINARY APPROACH FOR
RESEARCH PRIORITIES.
THIS WAS CONVENED AS A WORKING
GROUP OF THE NINDS ADVISORY
COUNCIL WHICH ALLOWED
INDEPENDENCE AND THE ABILITY FOR
THE RECOMMENDATIONS TO BE
TRANSMITTED AS FORMAL ADVICE TO
NIH OR WHAT WE HOPE WILL BE WHEN
WE HAVE OUR NEXT COUNCIL
MEETING.
I'LL GO MORE IN THAT PROCESS IN
A MOMENT.
BEFORE WE GET THERE I WANT TO
POINT OUT PAIN RESEARCH AT NIH
IS NOT LIMITED TO HEAL SUPPORT
OR EVEN THE MAJORITY
CONTRIBUTOR.
IT'S LARGELY FUNDED BY THE
INDIVIDUAL INSTITUTES AND
CENTERS.
SO THIS GRAPH HERE, THE REDDISH
COLOR SHOWS THE INVESTMENT FROM
THE I.C.s IN PAIN RESEARCH OVER
THE YEARS BOTH PROCEEDING HEAL
IN 2018 AND TO DATE TO FY23
WHERE WE HAVE THE MOST RECENT
DATA.
YOU CAN SEE THAT, THAT SALMON
REDDISH COLOR LARGELY TRACKS
WITH THE BLUE BAR THAT
REPRESENTS THE OVER ALL NIH
BUDGET.
SO THE TEAL COLOR ON TOP OF THAT
IS WHAT HEAL HAS CONTRIBUTED TO
SINCE THE FIRST APPROPRIATION IN
2018 WHICH I'LL MENTION WAS
TWO-YEAR MONEY A LOT OF THAT WAS
CARRIED INTO 2019 WHICH IS WHY
YOU SEE THE BOLUS THERE.
HEAL FUNDING HAS BEEN AT TIF --
ADDITIVE AND WE TRIED TO
PRESERVE THE FOCUS BY FOCUSSING
HEAL FUNDING ON A SPECIFIC
MISSION.
SO YOU ALL HAVE HEARD THIS
BEFORE BUT THE MISSION FOR HEAL
PAIN SO TO REDUCE PAIN IN OPIOID
USE DISORDER AND IMPROVE QUALITY
OF LIFE FOR ALL PEOPLE.
I.C.s CONTINUE TO SUPPORT
RESEARCH WITHIN THEIR OWN
MISSIONS.
I'LL ALSO TAKE THE OPPORTUNITY
TO SAY IT'S LARGELY SUPPORTED BY
THE NIH PAIN CONSORTIUM LINDA
HAS BEEN LEADING SINCE THAT
STARTED.
WHAT HAS THAT INVESTMENT DONE
FOR US?
THIS IS JUST A VERY HIGH LEVEL
SMATTERING LOOK BACK AT THE
SELECTED HIGHLIGHTS FROM THE
BEGINNING.
THERE HAVE BEEN A NUMBER OF
VALIDATED AND DEVELOPED
NON-OPIOID TARGETS.
WALTER MENTIONED THE CANNABINOID
RECEPTOR EARLIER THAT JUST
HAPPENED.
THERE'S A SMATTERING OF OTHERS
INCLUDING THE ENZYME SOLUBLE
AP
APOXIDE MODULATOR AND DEVELOPED
ACETAMINOPHEN ANALOGS FOR TEXAS
AND OTHERS IN DEVELOPMENT AS
WELL.
THIS IS JUST HITTING THE
HIGHLIGHTS.
SOW YOU'RE WELCOME TO GO AND
CLICK ON THESE LINKS AND TAKE A
LOOK IN MORE DETAIL AND THERE'S
BEEN THE FIRST IN HUMAN
PREDICTION OF THE CHRONIC PAIN
STATE USING INTRACRANIAL NEURAL
BIOMARKERS AND THROUGH THE
BACKPACK PROGRAM THERE'S BEEN
IMAGING BIOMARKERS THAT CAN
DISTINGUISH BETWEEN NORMAL AGING
AND CHRONIC CHANGES ASSOCIATE
WITH LOW BACK PAIN.
WE HAD A SIGNIFICANT INVESTMENT
IN PAIN LEADING TO OPTIMIZING
STIMULATION FOR IBS PAIN AND THE
FDA CLEARANCE FOR A VIRTUAL
REALITY DEVICE TO TREAT CHRONIC
PAIN.
AND THERE'S BEEN A NUMBER OF
CLINICAL TRIALS MANY OF WHICH
ARE ONGOING AND WRAPPING UP IN
THE COMING YEARS.
I'LL POINT OUT IN JANUARY WE HAD
PUBLICATIONS FROM THE HOPE
TRIAL, WHICH FOUND PEOPLE ON
CHEMO DIALYSIS WITH ASSOCIATED
PAIN COULD BENEFIT FROM OTHER
DEVICES AND WE HAVE EARLY CAREER
RESEARCHERS AND THE PURPOSE
NETWORK HAS BEEN A GREAT
RESOURCE OF CONNECTING PAIN
RESEARCHERS ACROSS CAREERS.
I'LL RUN THROUGH WHERE WE'VE
COME THROUGH IN THE LAST YEAR.
SO ABOUT A YEAR AGO WE CONVENED
THE INITIAL WORKING GROUP OF THE
NINDS ADVISORY COUNCIL TO
PROVIDE SCIENTIFIC GUIDANCE HOW
TO BEST ADVANCE PAIN RESEARCH IN
HEAL BY PROPOSING AND
PRIORITIZING FUTURE LOOKING
STRATEGIC RESEARCH PRIORITIES.
AND THAT GROUP WAS INFORMED BY A
REQUEST FOR INFORMATION THAT WE
PUT OUT AS NIH THAT SOLICITED
INPUT FROM THE BROADER COMMUNITY
AS TO WHAT SHOULD BE PRIORITIZED
AS PART OF THE HEAL INITIATIVE
BROADLY.
STARTING IN THE SUMMER THE
WORKING GROUP AND THEY FLUSHED
OUT THEIR EXPERTISE WITH
ADDITIONAL MEMBERS, HOSTED
PUBLIC WORKSHOPS AND REVIEWED
THE INPUT THAT CAME OUT OF THE
REQUEST FOR INFORMATION.
AND THEN LATE IN 2024, WE
BROUGHT THE GROUP TOGETHER TO
NARROW DOWN AND WE'RE A FEW
MONTHS BEHIND BUT WE ARE HERE
PRESENTING IT NOW AT THE MDWG
BUT THESE ARE NOT OFFICIAL AND
THESE ARE GOING TO HAVE TO BE
REVIEWED AND VOTED UPON BY THE
PARENT ADVISORY COUNCIL THE
NINDS COUNCIL AND THAT SHOULD BE
HAPPENING IN MID MAY.
AFTER THAT IT WILL ALL BE UP TO
US TO THREAD THESE PRIORITIES
INTO CONCEPTS AND FUNDING
OPPORTUNITIES AND WE NEED TO
START THAT WITH FY27 IN THE
COMING YEAR.
SO I WILL LEAVE IT THERE AND
TURN IT OVER TO MY ESTEEMED
COLLEAGUES, ROB AND KATHLEEN SO
I'M IN CHARGE OF THE SLIDES,
GUYS, SO LET ME KNOW WHEN YOU
WANT ME TO ADVANCE IT.
>> Dr. Gereau: THANKS, JACKIE.
THAT'S A GREAT SUMMARY THERE.
SO, WITH THAT PROCESS IN MIND
WHAT YOU SEE ON THE SLIDE IS THE
SEVEN DIFFERENT SUBCOMMITTEES
FOCUS AREAS THAT WE FOCUSSED ON
FOR THE DELIBERATION.
AND I WANTED TO POINT OUT A
COUPLE OF THINGS.
THERE WAS SOME GUIDING
PRINCIPLES AT THE OUTSET AND
JACKIE SORT OF TOUCHED ON THESE.
ONE WAS THAT -- AND HIS CAME
FROM FEEDBACK MEMBERS THE MDWG
RECEIVED AND QUESTIONS FROM THE
OUTSIDE AND ONE WAS CONCERNS
THAT WANTING TO MAKE SURE THE
I.C.s WEREN'T TAKING THEIR FOOT
OFF THE GAS AND YOU SAW THE NICE
ANALYSIS THE NIH STAFF PUT
TOGETHER SHOWING THE FUNDING IS
ACTIVE.
THE SECOND IS BECAUSE OF THE
NATURE OF THE WAY HEAL STARTED
AND ESPECIALLY WITH PAIN, THERE
WASN'T A STRATEGIC PLANNING THAT
REALLY FOCUSSED ON THE HEAL
MISSION IN TERMS OF DEVELOPING
NEW TREATMENTS AND REDUCING THE
IMPACT OF PAIN.
SO EVERYTHING THAT HAD TO BE
DONE QUICKLY AT THE BEGINNING OF
HEAL RELIED ON THE PRIOR
PLANNING PROCESSES BUT YOU HAD
TO PULL THE THREADS OUT TO
INFORM THAT.
YOU'VE SEEN A LOT OF PROGRESS
HERE AND THE ADDITIONAL THING
PEOPLE WANTED IS TO MAKE SURE
THERE WAS BROAD STAKEHOLDER
INPUT AND YEAR NINITIATED THE R
AND -- RFI AND WHAT HAS HEAL
DONE WELL AND SHOULD BE
CONTINUED BUT ALSO REALLY TO
LOOK AT GAPS.
WE'VE ALL DONE BEST WE CAN BUT
HAVE SPOTS AND AS HEAL BEEN OUT
IN THE WILD NOW MANY YEARS,
PEOPLE HAVE THE OPPORTUNITY TO
SPEAK UP AND OFFER THEIR
OPINIONS ON WHERE THESE
OPPORTUNITIES ARE AND WHERE THE
AREAS OF FOCUS SHOULD BE GOING
FORWARD.
SO THAT INFORMED THE DEVELOPMENT
OF THESE SEVEN COMMITTEES.
I WON'T READ THE CO-CHAIRS FOR
THE SUBCOMMITTEES BUT EACH WAS
POPULATED WITH MEMBERS OF THE
EXECUTIVE COMMITTEE AND
LEADERSHIP COMMITTEE FOR THE
RESEARCH PRIORITIZATION PROCESS
AND ADDITIONAL MEMBERS THE
COMMUNITY.
THEY BUILT THE SUBCOMMITTEES
AROUND THESE FOCUS AREAS.
YOU SEE THEM HEALTH, EQUITY AND
PAIN ACROSS THE LIFE COURSE,
NON-ADDICTIVE THERAPEUTIC
DEVELOPMENT AND OPTIMIZATION OF
INTERVENTIONS TO IMPROVE PAIN,
POLITICIAN OF HEALTH AND SERVICE
AND INTERSECTION OF PAIN AND
SUBSTANCE USE DISORDER AND PAIN
RESEARCH WORKFORCE AND TRAINING.
SO, WE CAN MOVE ON TO THE NEXT
SLIDE EACH OF THESE GROUPED WAS
CONVENED AND MET A FEW TIMES AND
HAVE THOUGHTS AND IDEAS THEY
MIGHT PRIORITIZE AND AS A
MICROCOSM OF THE LARGER GROUP TO
GET ADDITIONAL PUBLIC INPUT.
THAT HAPPENED IN THE FORM OF
PUBLIC WORKSHOPS THE
SUBCOMMITTEES CONVENED.
WE HEARD AGAIN FROM PEOPLE ON
BOARD.
WE SAW PEOPLE FROM THE COMMUNITY
JOINING AND THE IS LOTS OF
DIFFERENT STAKEHOLDERS.
THEY'RE PATIENTS AND PHYSICIANS
AND SCIENTISTS AND THERE'S GOOD
CROSS COMMUNICATION BETWEEN THE
GROUPS.
THOSE WORKSHOPS.
EVERYBODY HAD ONE OF THE THREE
OR FOUR OUR LONG WORKSHOPS.
SO BETWEEN JACKIE AND KATHLEEN
WE WERE PRESENT IN COMBINATION
IN ALL SEVEN OF THOSE.
THOSE SUBCOMMITTEES CAME UP WITH
PRIORITIES WERE THE MARCHING
ORDERS THERE THEY THOUGHT WERE
THE MOST IMPORTANT THING WITHIN
THEIR GROUP.
AND THEN THERE'S STILL OTHER
TOPICS THAT ARE STILL CONTAINED
IN SOME OF THE APPENDIX
MATERIALS FOR THE DRAFT REPORT.
ALL THIS DELIBERATION AND
DISCUSSION IS AVAILABLE.
BASED ON THAT THE CO-CHAIRS
REFINED AND COMBINED THE
CO-CHAIRS BEING KATHLEEN AND I.
SO WE GOT ALL THESE DISCUSSIONS
FROM THE DIFFERENT SUBCOMMITTEES
AND SOME WERE OVERLAPPING.
SO SOME THAT WERE COMBINED INTO
SINGLE RESEARCH PRIORITIES AND
PUT BACK TO ALL THE MEMBERS OF
THE SUBCOMMITTEES AND THEY WERE
VOTED ON IN A MALFI, DELPHI
PROCESS TO RANK AND PRIORITIZE
THESE.
BASED ON THE STATED GOAL OF
ADVANCING THE MISSION AND STATED
ON THE SLIDE, DON'T HAVE TO SAY
IT AGAIN BUT KEEPING THAT IN
MIND.
THERE'S A HUGE UNIVERSE OF PAIN
RESEARCH AND NEEDS TO FOCUS ON
WHAT WILL ADVANCE THE HEAL/PAIN
MISSION.
THROUGH THAT PROCESS WE CAME UP
WITH A NUMBER OF DIFFERENT
THINGS.
WHAT CAN LEAN AND I WILL PRESENT
ARE THE RESEARCH PRIORITIES AND
THERE'S 10 OF THOSE WE'LL PUT
FORWARD HERE AND SET UP CORE
PRINCIPLES.
YOU CAN GO TO THE NEXT SLIDE,
JACKIE.
SHE'S ARE THINGS THAT CAME TO
THE TOP OF SUBCOMMITTEES.
AND WE ALL FELT SHOULD BE
CONSIDERED ACROSS VARIOUS
DIFFERENT SCIENTIFIC FOCUS AREAS
IN PAIN RESEARCH AND SO WE'RE
RECOMMENDING THAT HEAL
INCORPORATE THESE PRINCIPLES
ACROSS ALL PAIN PROGRAMS TO
ADVANCE THE HEAL/PAIN MISSION.
YOU CAN SEE THESE HERE.
THE FIRST IS THE INVOLVEMENT OF
PEOPLE WITH LIVED EXPERIENCE.
THAT'S BEEN ADDRESSED IN OUR
DISCUSSION BY WALTER AND NORA.
THAT INCLUDES INVOLVEMENT IN THE
TRAINING OF INVESTIGATORS IN
TRAINING AND BASIC RESEARCH AND
FROM DESIGN ALL THE WAY THROUGH
DATA ANALYSIS IN THAT PROCESS.
THAT WAS SOMETHING THAT CAME TO
THE TOP AGAIN AND AGAIN.
THERE WAS A SENSE THERE NEEDED
TO BE A BETTER EDUCATION PROGRAM
IN PUBLIC AND PROVIDERS.
WE NEED BETTER EDUCATION OF
PUBLIC AND PROVIDERS AND
IMPLEMENTATION AND PUBLIC
CAMPAIGN.
REPORTING OF SEX AND LONGER TERM
OUTCOMES ACROSS THE LIFE SPAN SO
USING AGE TO ANIMALS TO REFLECT
THE VARIANCE OF PAIN AND ITS
EFFECTIVE TREATMENTS ACROSS THE
LIFE SPAN.
AGAIN, WE HEARD THIS EARLIER THE
IMPORTANCE OF UNDERSTANDING
CO-OCCURRING OR CO-MORBID
CONDITIONS.
THE INFLUENCE OF SOCIAL FACTORS
AND YOU A BIG ONE IS THE
IMPLEMENTATION PRINCIPLES
ILLUSTRATE HOW LONG IMPORTANT IT
IS WITH THE ROLLING OUT OF
OPIOID USE AND OVERDOSE DISORDER
AND PREVENTION STRATEGIES.
THE IMPORTANCE OF THOSE
INTEGRATION -- IMPLEMENTATION
PRINCIPLES TO THE SCIENCE.
BUILDING AND SUPPORTING
INTRODUCED BY OUR TEAMS TO
CAPITALIZE ON DIVERSE SKILLS AND
METHODOLOGIES.
AGAIN A THEME WE HEARD EARLIER
SUPPORTING SECONDARY ANALYSIS
AND SUPPORTING DATA SETS AND
SAMPLES GENERATED THROUGH ALL OF
THIS.
AND AGAIN MUCH OF THIS IS
ALREADY BEING STORED IN THE HEAL
ECO SYSTEM THAT YIELDS INSIGHTS
INTO GENESIS AND EXISTENCE OF
CHRONIC PAIN.
THAT'S THE BACKGROUND FOR HOW WE
THINK ALL OF THESE.
AND THIS IS IN NO PARTICULAR
ORDER AND RESEARCH PRIORITY A.
I'LL START WITH RESEARCH
PRIORITY ALPHA INSTEAD WHICH IS
TO SAY IT'S A MISCARRIAGE OF
JUSTICE WE HAD TO HEAR ABOUT
LINDA'S RETIREMENT AT THIS NOT
IN PERSON MEETING.
AS SOMEONE THERE FROM YEAR ONE
IS THE WAS MY PROGRAM OFFICER
WHEN I STARTED FROM YEAR ONE.
THANK YOU, LINDA FOR EVERYTHING
YOU'VE DONE.
YOU NEED TO COPY ALL THESE
COMMENTS IN THE CHAT TO KEEP AND
REMEMBER HOW MUCH WE APPRECIATE
YOU.
OKAY.
SO, PROPOSED SCIENTIFIC RESEARCH
PRIORITIES.
SUPPORTING COMPREHENSIVE
FELLOWSHIP AND CAREER
DEVELOPMENT AND MENTORED
RESEARCH SCHOLAR AWARDS FOR
INDIVIDUALS ACROSS ALL CAREER
STAGES.
IT WAS A POINT MADE TO INCLUDE
NON-U.S. CITIZENS AS FOLKS TO
HAVE OPPORTUNITIES IN THE
TRAINING DOMAINS.
THERE'S A LOT OF SUPPORT AND
DISCUSSION IN THE GROUP FOR
EXISTING TRAINING PROGRAMS PAIN
HAS DEVELOPED AND IN ADDITION TO
WHAT'S THERE LIKE THE K
PROGRAMS.
PEOPLE LIKE THE K PROGRAMS, FOR
EXAMPLE.
THIS IS TO FOSTER CONTINUED
GROWTH FOR ESTABLISHED PAIN
RESEARCHERS AND PROVIDE TARGETED
OPPORTUNITIES FOR INDIVIDUALS
WITH NO PRIERP PAIN RESEARCH
EXPERIENCE BUT HAVE STRONG
POTENTIAL TO DEVELOP IMPACT.
CAREERS IN PAIN SCIENCE.
AN OPPORTUNITY FOR SOMEONE WITH
A UNIQUE SKILL SET TO WORK WIN A
MENTOR IN THE PAIN SPACE AND
REALLY PROVIDE SUBSTANTIAL
IMPACT TO THE PAIN FIELD IN
BRINGING NEW THOUGHTS AND NEW
APPROACHES TO THE PAIN FIELD.
THIS IS REALLY A CAREER
DEVELOPMENT PRIORITY AND ONE
THAT RANKED VERY HIGH.
PRIORITY B, OKAY, THIS IS STATED
AS SUPPORT FOR THE DEVELOPMENT
OF MECHANISTICALLY VARIED AND
PHARMACEUTICAL PAIN MODALITIES.
IT SOUNDS COMPLICATED BUT THIS
PRIORITY COMES OUT OF AN
APPRECIATION FOR THE SUCCESS OF
THE ROBUST ECO SYSTEM FOR TAKING
ONLY CANDIDATES THROUGH THE
WHOLE PROGRAM WALTER TALKED
ABOUT BEFORE.
EVERYONE WAS VERY HAPPY WITH THE
IMPACT THAT HAS HAD ON THE PAIN
FIELD FOR MOTIVATING THERAPEUTIC
DEVELOPMENT IN THE CONTEXT OF
ACADEMIC LABS.
THAT SHOULD CONTINUE TO BE
FOCUSSED.
TARGET PROTEIN DEGRADATION AND
NEW MODALITIES ARISING TO MAKE
SURE THERE'S CAPABILITY AND
SUPPORT FOR THOSE INNOVATIVE
APPROACHES IN THE HEAL PACKAGE
OF OPPORTUNITIES.
PRIORITY C WAS SEEING A LOT OF
IMPACT OF THE EARLIER
INVESTMENTS FROM HEAL ON HUMAN
TISSUES BASED RESEARCH.
AND TO SUPPORT THERAPEUTICS IN A
COUPLE WAYS.
ONE IS USING THE KNOWLEDGE TO
IDENTIFY TARGETS BY
UNDERSTANDING INTERACTIONS
BETWEEN CELLS AND NETWORKS IN
HUMAN TISSUES, IDENTIFYING
TARGETS THAT HAVE A MUCH HIGHER
PROBABILITY OF BEING ATTRACTABLE
FOR TREATMENT OF HUMAN PAIN BUT
ALSO USING INFORMATION FROM
HUMAN BIOLOGY WITH EYES TO VERY
SPECIFIC DISEASE CONDITIONS.
USING THAT INFORMATION TO
DEVELOP A NEW GENERATION OF
HIGHLY PREDICTIVE AND DISEASE
SPECIFIC ANIMAL AND CELLULAR
MODELS.
THAT IS TO SAY, IF YOU LEARN
SOMETHING UNIQUE ABOUT SOMETHING
CHANGING IN DEGENERATIVE DISK,
FOR EXAMPLE, YOU MIGHT BE ABLE
TO DEVELOP AN ANIMAL MODEL THAT
SPECIFICALLY INCORPORATES THAT
ASPECT AND A LOT OF OTHER
DISCUSSION ABOUT THE USE OF IPSC
DERIVED NEURONS TO RECAPITULATE
HUMAN BIOLOGY IN ANIMAL AND
CELLULAR MODELS.
AT THIS POINT I'LL PASS ON TO
KATHLEEN TO PICK UP THE
REMAINDER AT LEAST.
>> Dr. Sluka: WE'LL TALK ABOUT
THE CHANGING PATTERNS AND HOW TO
IMPROVEMENT TREATMENT.
THE NEXT PRIORITY IS REALLY TO
DEVELOP PAIN PREVENTION
STRATEGIES TO PREVENT
DEVELOPMENT OF CHRONIC PAIN.
AND IT FOCUSES ON KEY POSITIONS
BUT IT FOCUSES ON PAIN.
MOST OF WHAT WE'VE DONE TO THIS
DATE IS A FOCUS ON TREATING
EXISTING CHRONIC PAIN.
AND WE'VE DEVELOPED PSYCHOSOCIAL
MODELS TO PREDICT BUT DON'T
PREVENT CHRONIC PAIN.
THIS IS LOOKING AT WAYS TO
PREVENT TO DEVELOP A TEST AND
NUMBER OF SCREENING TOOLS TO
LOOK FOR BIOMARKERS THAT CAN
PREDICT THAT TRANSITION IN
RESILIENCE AND SIMULTANEOUSLY
LOOKING AT DEVELOPING STRATEGIES
THAT CAN PREVENT PRIMARY MEANING
CAN WE CREATE LIFE STYLE CHANGES
AND DO THINGS WITH DIET TO
PREVENT DIABETES.
YOU'RE STARTING TO LOOK FOR WAYS
TO PREVENT PAIN ALTOGETHER TO
REDUCE THE NUMBER FROM 25% WHERE
IT IS NOW TO SAY 15% AND 10%.
AND THEN TO DEVELOP AND TEST
STRATEGIES THAT KIND OF PREVENT
WHAT WE CALL SECONDARY PAIN.
AFTER SOMETHING GETS IN ACUTE
PAIN CONDITION CAN WE PREVENT IT
FROM TRANSITIONING TO CHRONIC.
SO IN ORDER TO DO THAT WE DENOTE
TOOLS IN THE BIOMARKERS AND
FIGURE OUT ABOUT WHAT ARE
PREDICTORS AND RISK FACTORS AND
IF WE PREVENT ACUTE PAIN BETTER
DO WE PREVENT IT ALTOGETHER AND
HAVE BIOMARKERS TO PRE-CLINICAL
STUDIES TO SEE IF THEY'RE
CONTRIBUTING TO THE DISEASE AND
TRANSITION ITSELF TO CHRONIC
PAIN.
SO THIS ONE IS REALLY GEARED
TOWARDS PREVENTION STRATEGIES TO
PREVENT CHRONIC PAIN AND
HOPEFULLY REDUCE OUR OVER ALL
PERCENTAGE.
ONE IS GEARED FOR HAVE
BIOMARKERS TO PREDICT THE
RESPONSE TO TREATMENT?
CAN WE PREDICT SAFETY OR
ENGAGEMENT IN THE TREATMENT?
THEY MIGHT SERVE AS END POINTS
IN CLINICAL TRIALS.
THIS ONE CAME OUT THROUGH PEOPLE
WITH LIVED EXPERIENCE THIS WAS
REALLY IMPORTANT TO THEM.
WHAT HAPPENS CURRENTLY WITH
PEOPLE IS WE HAVE A LOT OF
TREATMENTS AND THEY GO THROUGH
ONE TREATMENT AND THAT FAILS AND
SPEND YEARS GETTING ON THE BEST
TREATMENT.
IF WE KNOW WHO RESPONDED TO
WHAT, WE COULD MAYBE START THEM
UP AT THE BEGINNING WITH
SOMETHING ADD EFFICACIOUS YAESHL
AND WE THOUGHT WE COUPREDICT TH
IN CLINICAL TRIALS AND THERE WAS
ALREADY A BIOMARKER PROGRAM THAT
COULD BE UTILIZED FOR THIS.
AND WE COULD BE LOOKING
PRIMARILY AT PREDICTIVE,
PROGNOSTIC AND PHARMACO DYNAMIC
MARKERS TO USING THE TREATMENT
WE HAVE AND MOVE THEM MORE
EFFECTIVELY IN THE CLINIC.
THIS TURN THE OUT TO BE A RATHER
LARGE ONE BECAUSE IT WAS BROUGHT
UP BY SEVERAL GROUPS.
WE'RE TALKING ABOUT TESTING
WHETHER AN INDIVIDUALIZED
TAILORED TREATMENT BASED ON
KNOWN MECHANISMS CAN IMPROVE
OUTCOMES?
AND CLINICIANS DO THIS AND SAY
THIS ALL THE TIME.
MOST OF OUR DRUGS ARE AIMED AT A
MECHANISM.
WE THINK THE MECHANISM IS
INVOLVED AND IN ORDER TO DO THIS
WE HAVE TO TAKE SEVERAL STEPS.
FIRST WE HAVE TO DEVELOP
COMPOSITE BIOMARKER SIGNATURES
WHERE WE DEEPLY PHENOTYPE PEOPLE
AND SEE IF THEY'LL FIT INTO
DIFFERENT BIOLOGICAL GROUPS.
BASED ON MECHANISMS AND THEY
INCLUDE BIOLOGICAL MARKERS AND
BIOLOGICAL COMPONENTS AS WELL AS
PATIENT-REPORTED OUTCOMES LIKE
BIO-SOCIAL FACTORS COMBINED
TOGETHER TO FIGURE OUT
MECHANISMS IN INDIVIDUALS.
WE CAN THEN SIMULTANEOUSLY LOOK
AT WHAT WE'RE LOOKING AT AND
INVESTIGATE A PERSONALIZED
APPROACH BY MATCHING A PERSON'S
PHENOTYPE OR SIGNATURE WITH THE
UNDERLYING MECHANISMS AND
TREATMENTS THAT ADDRESS THOSE
MECHANISMS.
AND INVESTIGATE HOW OUR
NON-PHARMACOLOGIC TREATMENTS
WORK WHILE MANY -- MAY REDUCE
PAIN WE DON'T KNOW HOW THEY WORK
AND WE CAN MATCH THE
NON-PHARMACOLOGICAL
INTERVENTION.
THIS WOULD BE MULTI-STEP PROCESS
WILL LEADING TO A TAILORED
MECHANISTIC BASED APPROACH WE
LOPE TO IMPROVE OUTCOMES.
THE NEXT WAS TO TEST THE INITIAL
PAIN THERAPY AND ORDER OF TIMING
OF MULTI-MODAL APPROACHES AND I
USUALLY GIVE PEOPLE THIS AND
THAT DIDN'T WORK, LET'S PUT YOU
ON THIS.
IS IT BETTER TO START SOMEBODY
WITH THAT PHARMACEUTICAL
TREATMENT OR FOLLOW-UP WITH
ANOTHER INTERVENTION OR THE
OTHER WAY?
AGAIN, ALL OF OUR TREATMENTS
HAVE NON-SPECIFIC AFFECTS WHICH
COULD BE A PLACEBO AFFECT.
IT COULD BE AN AFFECT OF THE
CLINICIAN-PATIENT INTERACTION
AND THAT'S PART OF THE PROCESS.
THIS PRIORITY IS TO LOOK AT AND
GEARED TOWARDS INDIVIDUALIZATION
OF THE TREATMENT.
AGAIN, WE WOULD NEED TO IDENTIFY
PREDICTORS OF TREATMENT RESPONSE
WHICH MATCHED WITH ONE OF OUR
PRIORITIES ALREADY.
WE WOULD EVALUATE COMBINATIONS
AND TIMING OF APPROACHES.
THIS WOULD INCLUDE ALL THERAPIES
AND NON-DRUG APPROACHES AND
PHARMACEUTICALS AND THIS IS
STILL GEARED TOWARDS MORE
INDIVIDUALIZATION BUT ALSO ORDER
AND TIMING AND WHICH THERAPIES
GO WHEN THIS PRIORITY IS TO
PRIORITIZE CLINICAL AND
COMMUNITY EMBEDDED RESEARCH.
IMPLEMENTATION EFFECTS OF THE
STUDIES AND PRAGMATIC TRIALS
LOOKING FOR REAL WORLD IMPACT
SCALABILITY AND SUSTAINABILITY.
WHILE WE CAN DO ALL THE STUDIES
IN THE WORLD, AS NORA SAID, IF
WE DON'T ACTUALLY CHANGE
CLINICAL PRACTICE, WE'VE MADE NO
PROGRESS.
SO THESE ARE ABOUT GETTING IN
THE REAL WORLD AND PARTNERING
WITH STAKEHOLDERS INCLUDING
CLINICIANS AND PAYERS AND HEALTH
CARE SYSTEMS TO CHANGE PRACTICE
AND ASSESS IF WE CAN GET THIS IN
THE REAL WORLD.
WILL IT BE USED?
IS IT EFFECTIVE AND CAN WE KEEP
IT IN THAT PRACTICE FOR LONG
TERM WHICH IS THE SUSTAINABILITY
PART.
ASSESSING AND INTEGRATING SHARED
DECISION MAKING TOOLS OFTEN
TALKED ABOUT IN IN CLINICAL
RESEARCH AND PRACTICE BUT HAVE
NOT BEEN WELL TESTED.
WE NEED TO EVALUATE INTEGRATE
IVE CARE MODELS AND HAVE ACCESS
TO A LARGE PAIN SYSTEM IN WHICH
THE WORK AND COMMUNITY SETTINGS
MAY BE A GREAT WAY TO GET SOME
OF THESE TREATMENTS AND HAVE
HIGH-VALUED PAIN INTERVENTIONS
AND IT MAY BE A PHARMACEUTICAL
OR A COMBINATION OF A MULTIMODAL
APPROACH WITH DE-IMPLEMENTATION
OF LOW INTERVENTIONS WE KNOW ARE
HIGH COST OR HIGH RISK.
AND SO THIS IS REALLY ABOUT REAL
WORLD IMPACT AND TRANSLATING OUR
FINDINGS DIRECTLY INTO CLINICS.
NEXT IS TO IDENTIFY POPULATIONS
DISPROPORTIONATELY AND HIGHLY
IMPACTED BY PAIN AND SUBSTANCE
USE.
WE NEED TO UNDERSTAND THE
MECHANISMS THAT DIFFERENTLY
IMPACT THESE POPULATIONS AND WE
NEED TO DEVELOP INTERVENTIONS TO
ADDRESS THIS IMPACT.
AS WE KNOW, MANY PEOPLE GOT TO
PAIN OR CHRONIC PAIN BECAUSE OF
SUBSTANCE USE.
NOW, BECAUSE THEY WERE TRYING TO
REDUCE THEIR PAIN.
IF WE DON'T REDUCE THEIR PAIN,
WE CAN'T MOVE THAT FORWARD.
SIMULTANEOUSLY, SUBSTANCE USE
ITSELF AND REPETITIVE USE CAN
RESULT IN INCREASED PAIN.
THERE'S AN INTERACTION WE NEED
TO BE LOOKING AT.
AND WE NEED TO DEVELOP HIGH
IMPACT OR HIGH POTENTIAL FOR
IMPACT INTERVENTION.
THIS MAY BE DESCRIBING OPIOIDS
AND REPLACING THEM WITH
SOMETHING ELSE OR OTHER PAIN
MEDICATIONS.
THERE'S A WHOLE LIFT IN THE
PRIORITIES.
WE NEED TO -- LIST IN THE
PRIORITIES.
WE NEED TO TEST THEM FOR IMPACT.
PRECLINICAL STUDIES AND NEED TO
BE DONE THAT ADDRESS THE
MECHANISMS OF THE RELATIONSHIP
BETWEEN THIS SO THAT WE CAN THEN
DEVELOP NOVEL INTERVENTIONS
BASED ON THOSE MECHANISMS.
YOU CAN SEE COMMUNITY ENGAGEMENT
WHICH IS CRITICALLY IMPORTANT IN
THE POPULATION AS WELL.
LOOK TO IMPLEMENT THIS IN
POPULATIONS WITH SUBSTANCE USE
DISORDERS.
I THINK THIS IS THE LAST ONE.
AND THE LAST ONE IS INTERVENTION
OF CHRONIC PAIN.
MOST NON-DRUG APPROACHES ARE
SAFE AND HAVE EFFICACY.
YET, WE DON'T NECESSARILY KNOW
HOW THEY ALL WORK.
SO WE NEED TO UNDERSTAND HOW
THEY ARE WORK TO IMPROVE THEM
CLINICALLY.
WE NEED TO IDENTIFY EXISTING
EVIDENCE-BASED APPROACHES FOR
ADDICTION NOBODY RESPOND TO ALL
TREATME
TREATMENTS LOOK AT PREDICTORS
AND BIOMARKERS TO IMPROVE AND
IDENTIFY THE PEOPLE WHO WILL
RESPOND AND THIS COMES BACK TO
OPTIMAL TIMING OF THE
INTERVENTION, SHARED DECISION
MAKING AND PERSON-CENTERED CARE.
THIS IS A CALL OUT TO NOT ONLY
DO THE THINGS WE TALKED ABOUT
AND THE OTHER PRIORITIES FROM
PHARMACEUTICAL TREATMENTS BUT
ALSO MAKE SURE THIS IS DONE FOR
NON-DRUG APPROACHES WHICH UP
UNTIL THE HEAL INITIATIVE HAVE
BEEN QUITE UNDER STUDIED.
HEAL HAS DONE A GREAT OF
SUPPORTING THESE NON-DRUG
APPROACHES.
THAT IS THE LAST OF OUR
PRIORITIES.
THIS IS JUST A REVIEW OF THEM.
THEY'RE VERY BROAD AND MANY ARE
ABOUT DRUG DISCOVERY RESEARCH
WITHIN HUMANS OR BASIC PRE
CLINICAL STUDIES TO IDENTIFY
MECHANISMS THAT THEN COULD BE
TAKEN BACK TO THE CLINIC OR FROM
THE CLINIC, VICE VERSA.
IT INCLUDES BOTH PREVENTION AS
WELL AS TREATMENT OF EXISTING
PAIN.
IMPLEMENTATION AND OF COURSE
DIFFERENT CO-OCCURRING PAIN IN
INDIVIDUALS WHICH IS VERY
IMPORTANT.
LASTLY, I WILL THANK OUR
COMMITTEE, I BELIEVE.
SO, YOU IS YOU THE COMMITTEES.
THESE HAVE THE SUBCOMMITTEE
MEMBERS.
AND THERE WERE A LOT OF THEM WHO
ALL VOLUNTEERED THEIR TIME AND
WERE AMAZING.
THEY CAME TO THE TABLE WITHOUT
ALL THEIR BIASES TO TRY TO BRING
WHERE WE REALLY THINK THE DEAL
NEEDS TO GO AND FROM THAT AND
THE EXECUTIVE COMMITTEE AS WELL
WAS JUST AMAZING TO WORK WITH
BECAUSE EVERYBODY THOUGHT WHERE
DO WE REALLY NEED TO BE GOING.
AND TRIED TO BRING TOGETHER
WHERE WE ARE NOW AND WHERE WE'D
LIKE TO BE IN THE NEXT FIVE
YEARS.
WE THINK THESE WILL HELP PROPEL
US THERE.
WE WANT TO THANK ALL OF THEM AND
OF COURSE ALL OF OUR STAFF THE
ADD NIH AND PAIN RESEARCH BACK
WHEN WE DIDN'T HAVE MUCH
SUPPORT.
WE WERE REALLY THANKFUL FOR THAT
AND REALLY THANKFUL FOR SUPPORT
THROUGH ALL OF THESE INITIATIVES
AS WE MOVE THE HEAL STRATEGIC
PLAN FORWARD.
WITH THAT, I THINK I GET TO TURN
IT BACK TO JACKIE.
>> Jackie: IS THERE ANYTHING YOU
WANT TO ADD ABOUT NEXT STEPS
BEFORE I GET THERE, ROB?
>> Dr. Gereau: IT'S GOOD.
THERE'S A LOT.
WE HAD A LOT OF HELP FROM
MICHAEL AS OUR LEADERSHIP
MEMBER, PERSON WITH LIVED
EXPERIENCE.
I WAS CHECKING TO SEE IF HE WAS
ON THE CALL BUT I DON'T THINK HE
IS.
IF YOU'RE HERE AND WANTED TO SAY
ANYTHING, THAT'D BE GREAT.
AND WE HAVE MEMBERS OF THE
EXECUTIVE COMMITTEE HERE IF THEY
HAVE ANYTHING THEY'D LIKE TO ADD
AT THIS POINT.
>> I WAS GOING TO PUT IT IN THE
CHAT BUT MY CHAT IS DISABLED FOR
SOME REASON.
I WANT TO UNDERSCORE THE
LEADERSHIP OF ROB AND KATHLEEN
AND JACKIE.
THIS WAS AN INCREDIBLY
ACCELERATED PROCESS AND I THINK
PEOPLE CAME TOGETHER REALLY
WELL.
IT MAY BE EVIDENT OR NOT BUT I
THINK THE WAY WHEN WE GOT
TOGETHER AS EXECUTIVE COMMITTEE
IN JANUARY TO REALLY MAKE
DECISIONS ABOUT PRIORITIES, I
THINK PEOPLE WERE SO THOUGHTFUL
ABOUT THE WAY THESE THINGS
INTERWOVE AND ROB STARTED WITH
THE CORE THEMES.
I THINK A LOT OF THOSE ARE
CARRIED THROUGHOUT THIS.
I LOVE THE CONFIDENCE IT WOULD
POTENTIATE RESEARCH ACROSS THE
BOARD AND I THINK REALLY
REFLECTED THE PRINCIPLES OF THIS
GROUP IN TERMS OF THE INTERFACES
IN THESE AREAS.
JUST REALLY APPRECIATED BEING
PART OF THE PROCESS AND WANT IT
UNDER SCORE MY CONFIDENCE AND
HOW IT WILL SUPPORT THE
STRATEGIC PLANNING MOVING
FORWARD.
>> THANK YOU.
SO, AS FAR AS NEXT STEPS WE'RE
HERE WITH YOU AT AN
INFORMATIONAL STAGE BUT THEY'RE
DRAFT AND THESE WILL BE
PRESENTED I BELIEVE MAY 14 --
FORGIVE MY TYPO.
MAY 14 AT THE OPEN SESSION OF
THE NINDS ADVISORY COUNCIL FOR
FINAL DISCUSSION AND THEN A VOTE
FOR APPROVAL AT WHICH POINT
THEY'LL BE OFFICIALLY
TRANSMITTED TO NIH.
SO WE WELCOME YOUR THOUGHTS HERE
NOW AND THEN IF ACCEPTED AT THAT
MEETING IN MAY, NIH WILL
IMPLEMENT THESE THROUGH CONCEPT
DEVELOPMENT AND BEYOND.
I'LL GO TO THE LAST SLIDE WHICH
WAS THE PICTURE.
WE HAD TO ADD ZOOM SQUARES HERE
OF OUR IN PERSON MEETING IN
JANUARY KINDLY HOSTED BY ROBIN
ST. LOUIS AND GLAD WE WERE ABLE
TO DO THAT WHEN WE COULD AND
THANKS TO MY NIH COLLEAGUES WHO
WERE CRITICAL IN THIS ENTIRE
PROCESS AND THERE WERE MANY OF
THEM AS YOU CAN SEE ON THE SLIDE
AS WELL AS THE GROUP HERE, THE
CO-CHAIRS.
IT WAS A FRUITFUL AND
COLLABORATIVE ENDEAVOR.
I REALLY APPRECIATE KATHLEEN AND
ROB, YOUR LEADERSHIP ON THIS.
I'LL LEAVE THIS SLIDE UP AND IF
WE HAVE TIME.
WE'VE STUNNED THEM INTO SILENCE.
>> TOO MUCH INFORMATION.
PERHAPS THE GROUP ALONG WITH
DR. SMITH AGREE WILDLY WITH THE
CONCLUSIONS, WHICH I APPRECIATE
THE PHRASING.
I WAND YOU ALL TO KNOW THAT WE
APPRECIATE AN ADDITIONAL INPUT,
THOUGHTS AND REFLECTIONS
ESPECIALLY BETWEEN NOW AND MAY
14 BUT ALSO BEYOND.
AGAIN, WE REALLY APPRECIATE
EVERYBODY'S HARD AND THOUGHTFUL
WORK ON THIS.
IT'S REALLY AN IMPORTANT EFFORT.
>> I WANT TO THANK THE GROUP.
IT REFLECTS, BROAD THOUGHTFUL
INPUT AND I REALLY LIKE HOW THIS
SPEAKS TO WHAT WE'VE DONE
ALREADY AND EXPANDING THAT AND
ALSO NEW POINTS OF VIEW.
NEW WAYS TO THINK ABOUT AND
SHOUT OUT TO THE EFFORTS OF
RAISING THE IMPORTANCE OF
PREVENTION.
THIS IS SOMETHING THAT IS NOT
EASY.
I APPRECIATE THE GROUP.
I KNOW IT WAS PROBABLY DIFFICULT
TO COME UP WITH RECOMMENDATIONS
BECAUSE WE'RE KIND OF ALMOST
STARTING FROM SCRATCH.
WE KNOW SOME OF IT ABOUT
PREVENTING CHRONIC PAIN BUT ALSO
ABOUT MAKING SURE THAT PEOPLE
WITH ACUTE PAIN DON'T
TRANSITION.
WE FOCUSSED ON UNDERSTANDING THE
TRANSITION BUT DON'T REALLY
UNDERSTAND HOW TO NOT TRANSITION
AND TO RESOLVE ACUTE PAIN.
I'M VERY HOPEFUL YOUR
RECOMMENDATIONS WILL REALLY
ENCOURAGE MORE WORK IN THIS AREA
ALSO IN THE AREAS OF
IMPLEMENTATION OF HOW TO MAKE
SURE -- AND THIS IS SOMETHING
THAT FALLS IN THE OTHER CATEGORY
OF WORK THE HEAL INITIATIVE
SPENT A GOOD AMOUNT OF TIME AND
EFFORT ON AND WITH SOME GOOD
RESULTS ALREADY BUT WE NEED MORE
SO I APPRECIATE YOU ARE
HIGHLIGHTING THIS.
I THINK BOTH ENDS OF THE
SPECTRUM IN THE AREAS WHERE
WE'VE ALREADY DONE A LOT BUT
WANT MORE AND IN NEW AREAS THAT
ARE CHALLENGING.
I'M REALLY GLAD YOU'VE COVERED
THAT WHOLE SPECTRUM.
THANK YOU VERY MUCH.
>> Dr. Gereau: THANK YOU,
DR. LANGEVIN.
SOME IS OVERLAPPING AS YOU
MENTIONED WITH THINGS WE'RE
ALREADY DOING AND RE-EMPHASIZING
THAT BUT THERE'S A TENDENCY TO
FOCUS ON GAPS AND IT WAS HARD TO
CAPTURE WHAT THINGS PEOPLE WERE
SAYING WERE GOING WELL.
THERE WAS SUPPORT IN THE
MEETINGS FOR THAT BUT DOESN'T
ALWAYS COME UP HERE.
YOU SEE BIOMARKERS AND THINGS
LIKE THIS THAT HAVE ALWAYS BEEN
THERE IN THE HUMAN TISSUE
RESEARCH.
>> THIS HAS BEEN A HERCULEAN
EFFORT AND WHEN I READ THE SLIDE
DECK I WAS EXCITED TO SEE THE
IMPLEMENTATION AND HOW SERVICES
PILLAR WHICH AS A CLINICIAN
WE'RE ALWAYS INTO IMPLEMENTATION
AND HOW TO GET CLINICIANS ON
BOARD AND CLINICIAN EDUCATION IS
HUGE AND THAT'S ONE OF YOUR
GOALS AND PRIORITIES.
ANOTHER PLACE THAT NEEDS
ATTENTION AND I DON'T THINK
WE'RE THERE YET IS LOOKING AT
THE SYSTEMATIC BARRIERS THAT GET
IN CLINICIANS WAY OF
IMPLEMENTING BEST PRACTICE.
I DIDN'T SEE IT IN YOUR SLIDE
DECK BUT I THINK IT'S THAT WHAT
GETS IN THE WAY OF IMPLEMENTING
BEST PRACTICE AND CLINICIANS'
HEARTS IN THE RIGHT PLACE AND
IT'S EASY TO TARGET EDUCATION
PROGRAMS, PROFESSIONAL EDUCATION
PROGRAMS AND P.T. AND ALL THAT
BUT THERE'S CLINICIANS ALREADY
DOING WHAT THEY'VE BEEN DOING
FOR 20, 30 YEARS.
HOW DO YOU CHANGE ATTITUDES AND
PERCEPTIONS OF EXISTING
CLINICIANS AND THE CLINICIAN
BECOMES THE SUBJECT IN THE
STUDY.
I DON'T THINK WE'VE DONE THAT
ENOUGH.
WE NEED ALL OF THAT BUT AT HUMAN
BEING -- AT 4:00 I HAVE
PATIENTS COMING IN THAT NEED
HELP.
I WOULD PUT IN A PLUG FOR THE
IMPLEMENTATION OF SYSTEMATIC
BARRIERS AND FINDING WAYS TO
PUSH THIS OUT THE DOOR FOR
EXISTING CLINICIAN.
THANK YOU FOR YOUR WORK.
>> LIN, YOU MAY WANT TO ADDRESS
SOME OF THIS BECAUSE I KNOW WE
TALKED ABOUT A LOT OF.
>> I APPRECIATE THE COMMENTS.
THEY WERE SPOT ON.
I ALLUDED TO BUT DIDN'T SAY MUCH
ELSE ABOUT THE CORE THEMES.
ONE OF THE THEMES THAT CAME UP
IN THE IMPLEMENTATION HEALTH
SERVICES GROUP IS THE IMPORTANCE
BAKING THAT IN FROM THE
CONCEPTION AROUND THEY KNOW THE
BARRIERS AND WE HAVE TO PLAN
THAT IN AND CAN'T BE AN
AFTERTHOUGHT.
WE TRIED AS BEST WE COULD TO
BUILD THAT IN.
I ALSO THINK, KATHLEEN, YOU
HIGHLIGHTED THE COUPLING OF OR
GETTING THINGS OUT AND
IMPLEMENTED BUT ALSO THE
IMPLEMENTATION WE HAVEN'T BEEN
SO GOOD AT.
IT ALSO CALLS FOR INVOLVEMENT OF
THE HEALTH CARE SYSTEMS AND
CLINICIANS TO HELP US THINK
THROUGH THE BARRIERS OF DOING
THAT.
THAT WERE PARTICULAR KINDS OF
APPROACHES THAT ALLOWED FOR
THAT.
I THINK THIS WAS METHED.
WE ALL DID HALF DAY VIRTUAL
WORKSHOPS AND SOME WERE
HIGHLIGHTED IN THE PROGRAMS AND
PLEASE MAKE RECOMMENDATIONS IF
IT'S POSSIBLE TO EDIT THEM AT
ALL.
>> GO BACK TO THE WORDING AND
MAKE SURE THAT'S INCLUDED IN
THAT PRIORITY AS WELL WHICH WE
WILL BE LOOKING AT.
THAT'S WHY WE'RE HERE TO GET
FEEDBACK.
>> Dr. Gereau: AND BAKED INTO
WHAT YOU WERE SAYING, SHARON,
BARRIERS TO ACTUALLY HAVING THE
CHANGES OCCURRING.
AND THERE'S SO MUCH DISCUSSION
ALONG THE WAY AND AREAS WHERE
NIH IS NOT ABLE TO OPERATE ARE
CHALLENGES TO THAT.
I THINK WHAT YOU'RE TALKING
ABOUT WAS SO PERVASIVE AMONG THE
HEALTH CARE DELIVERY AND ALL
THAT.
THAT DEFINITELY NEEDS TO BE TOP
OF MIND IF IT'S NOT ADEQUATELY
IN THERE.
>> YES, WE NEED TO EDUCATE THE
CLINICIANS AND PULL IN SOME
HOSPITAL ADMINISTRATORS BECAUSE
THEY HOLD THE PULSE STRINGS AND
IMPLEMENT WHAT THE CLINICIAN IS
DESPERATELY WANTING.
THAT'S A WHOLE OTHER LEVEL AND
COULD BE UNDER THE NIH PURVIEW
BUT IN THE LONG RUN THAT'S WHERE
A LOT OF THE BARRIERS ARE.
>> AND A LOT OF THAT COULD BE IN
THE DESIGN OF YOUR TRIAL.
>> Dr. Sluka: BAKED IN FROM THE
BEGINNING IN THE TRIAL.
>> I DON'T THINK RESEARCHERS
THINK IN THOSE TERMS WHEN
THEY'RE RIGHT WRITING THEIR RO1.
>> Dr. Sluka:
>>
>> Jackie: I WANT TO ECHO
EVERYBODY'S THANKS TO YOU.
YOU DESERVE A HUGE RAISE COMING
YOUR WAY.
IT WAS REALLY HARD FOR JUST OUR
GROUP SO I CAN IMAGINE HOW HARD
IT WAS LOOKING AT ALL THE
RECOMMENDATIONS THAT CAME IN
FROM EACH OF THE WORK GROUPS.
BUT YOU BOTH DID AN AMAZING JOB.
JACKIE AS WELL AND THANK YOU FOR
INCLUDING THE DIVERSE
PERSPECTIVES AND HATS OFF TO
VIVIAN AND OTHERS INVOLVED IN
SUPPORTING PEOPLE WITH LIVED
EXPERIENCE TO BETTER UNDERSTAND
THE PROCESS AND BE ABLE TO
CONTRIBUTE TO IT.
I GUESS MY ONE QUESTION IS WHEN
I THINK OF THE OVER ARCHING
THEMES MORE OF A LOGISTICAL AND
PRAGMATIC QUESTION AND MAYBE TOO
EARLY TO ANSWER BUT WHEN I THINK
ABOUT THE THEMES THAT CUT ACROSS
THE RESEARCH PRIORITIES AND
RECOMMENDATIONS SOME SEEM EASY
OR SIMPLE TO INCORPORATE INTO
FOAs ACROSS ALL KINDS OF
RESEARCH.
FOR EXAMPLE, INCLUSION OF
PATIENT AND OTHER COMMUNITY
STAKEHOLDERS BUT OTHER ONES LIKE
PUBLIC EDUCATION CAMPAIGN ON
PAIN OR PAIN RESEARCH DON'T.
I GUESS MY QUESTION IS HOW DO
YOU ENVISION DEALING WITH THOSE
CROSS-CUTTING THEMES?
ARE THEY MORE THEMES THAT HAVE
BEEN HIGHLIGHTED AND THAT YOU'LL
ENCOURAGE PEOPLE TO TRY TO
ADDRESS ACROSS THE RESEARCH
PRIORITIES AS THEY SUBMIT
PROPOSALS?
OR ARE THOSE GOING TO BE HANDLED
SEPARATELY IN SOME INSTANCES?
AGAIN, IF IT'S TOO SOON TO
ANSWER THIS QUESTION, SORRY.
>> SOUNDS LIKE A WALTER QUESTION
TO ME.
>> IT DEFINITELY SOUNDS LIKE
SOMEBODY ELSE'S QUESTION.
WE DON'T IMPLEMENT.
>> I REALIZE THAT.
IT'S MORE OF A BROAD QUESTION TO
THE NIH ABOUT HOW YOU'RE
THINKING HOW THESE THEMES ALIGN
WITH THE PRIORITIES AND HOW
THOSE MIGHT BE INCLUDED OR NOT
INCLUDED OR HANDLED SEPARATELY
WITH FOAs.
>> I'LL TAKE A STAB AND THEN
PASS IT TO WALTER IF HE WANTS TO
ADD ANYTHING ELSE.
ONE OF THE THINGS WE TALKED
ABOUT THINGS ON THE CUSP OR
OUTSIDE OF NIH'S PURVIEW, WE
STILL HAVE OTHER CHANNELS
POTENTIALLY NOT THROUGH HEAL
FUNDING OPPORTUNITIES BUT
THROUGH OUR INTERAGENCY
COMMITTEES WHERE WE WORK WITH
THE CDC OR WORK WITH OTHER
COLLEAGUES AT HHS TO PROMOTE
PAIN RESEARCH ACROSS THE FEDERAL
GOVERNMENT.
I THINK THOSE CAME THROUGH FOR
OTHER WAYS TO THREAD THEM
THROUGH NIH PROCESSES AND
INTEGRATED INTO FUNDING
OPPORTUNITY AND WOE MAY HAVE TO
FIND OTHER CHANNELS AND HOW TO
PROMOTE THOSE.
I KNOW WE HAD DISCUSSED WITH
LINDA'S LEADERSHIP DEVELOPED
INTERAGENCY PAIN RESEARCH
COORDINATING COMMITTEE.
THAT'S ONE IN PARTICULAR WHERE
THE DISCUSSION OF THE BROADER
PUBLIC MIGHT BE MORE APPROPRIATE
VENUE THAN HEAL FUNDING
OPPORTUNITIES.
I WELCOME YOUR ADDITIONAL TAKE,
WALTER?
>> Dr. Koroshetz: I THINK TO GET
TO THE GENERIC POINT ABOUT NIH'S
ROLE OF DEVELOP DATA AND
POLICIES MADE FOR HEALTH.
SO WE DON'T DO GUIDE RYANS.
-- GUIDELINES.
WE RELY ON PASSING THE DATA TO
OTHER GROUPS TO OPERATIONAL IIZ
IS AND WE ALL KNOW HOW IMPERFECT
THE SYSTEM IS.
WHAT WE DO IS LOOK FOR PARTNERS
THAT WOULD BE CONDUCIVE TO THAT
TYPE OF RESEARCH THAT WOULD THEN
LEAD TO ACTIONABLE CHANGES.
SO, I THINK WE BENEFIT A LOT BY
WORKING WITH PEOPLE LIKE GLEN AT
KAISER.
WE HAVE A CALL OUT NOW FOR
PROGRAMS TO DO PAIN RESEARCH IN
HEALTH CARE SYSTEMS.
I THINK IT'S BEEN VERY HARD TO
MOVE THAT NEEDLE BUT I WOULD SAY
HELEN COULD CHIME IN ONE OF THE
REAL SWATS IN WORKING WITH THE
V.A. WHERE WE CAN DO PRAGMATIC
RESEARCH AND IF IT WORKS THEY
CAN TAKE IT ON IN THEIR CLINICAL
PRACTICE AND THERE'S A GOOD
PROGRAM WITH THE V.A. SYSTEM.
AND V.A. DOES A GOOD JOB.
WE REALLY NEED PARTNERS WILLING
TO PLAY BALL AND I THINK THE
PERCENT STRING IS THE BIG
ELEPHANT IN THE ROOM.
IF YOU'RE MAKING A LOT OF MONEY
OFF BACK PAIN SURGERY YOU'RE NOT
GOING TO BE THAT INTERESTED IN
PREVENTING BACK PAIN SURGERY BY
USING ALTERNATIVE METHODS.
IT'S KIND OF CRUDE BUT I THINK
WE KNOW WHAT THE ISSUES ARE OUT
THERE AND OUR SYSTEM IS HEAVILY
RUN BY FINANCES AND NOT PATIENT
OUTCOMES EXCEPT IN THESE
ORGANIZATIONS WHERE THEY ARE
BASICALLY OUT OF CONTROL OF THE
FINANCES.
IT'S PROBABLY CHEAPER TO RUN AN
EFFECTIVE PAIN MANAGEMENT SYSTEM
WHERE THERE'S GOOD EVIDENCE ON
WHO NEEDS TO GET IMAGING AND WHO
NEEDS TO GET INJECTIONS OR WHO
DOESN'T NEED INJECTIONS BUT
NEEDS IMAGING.
SO THAT MIGHT BE THE PLACE TO GO
IF YOU CAN GET A REALLY
INTERESTED PARTNER.
WE'RE LOOKING AT THEM BUT
HELENE.
>> Dr. Langevin: I LOVE
EVERYTHING YOU JUST SAID WALTER
AND GO A STEP FURTHER IN THAT
THE V.A. IS AN INTERESTING
LABORATORY TO EXPLORE -- IF YOU
THINK ABOUT IT, IT'S A SINGLE
PAIR, GOVERNMENT-RUN SYSTEM
WHERE DECISIONS CAN BE MADE AND
IMPLEMENTED VERY EFFECTIVELY.
THE OTHER THING THE V.A. IS
DOING VERY INTERESTING RIGHT NOW
IS THE IDEA THAT PAIN IS NOT
JUST AN ISOLATED THING.
THERE'S A WHOLE PERSON AROUND IT
AND THEY'RE REALLY INCORPORATING
WHOLE PAIN CARE WITH PERSON CARE
AND THAT'S HOW THEY'RE LOOKING
AT IT.
TO ADDRESS SOMEBODY'S PAIN IT'S
NOT DISCONNECTED FROM HELPING
THEM WITH ALL THE OTHER ISSUES
THEY HAVE IB THEIR HEALTH AND
LIFE SO I THINK THE V.A. IS
REALLY THE PLACE TO LOOK FOR
INNOVATION IN MANY AREAS
INCLUDING PAIN MANAGEMENT AND
ALSO MAKING SURE IT'S CONNECTED.
THANKS FOR MENTIONING THAT,
WALTER.
THE FACT THAT WE HAVE LEARNED
HOW TO WORK IN COLLABORATION
WITH THE V.A., TO DO -- BECAUSE
IT'S NOT A SIMPLE THING.
WE'RE NOW HAVING TO HAVE SERIOUS
COLLABORATION WITH THE V.A. ON
PROJECTS WITH THE PAIN RESEARCH
COLLABORATORY THAT IS WORKING
REALLY WELL.
I THINK THE HEAL INITIATIVE IS
NOW PART OF THIS.
SO I THINK IT'S VERY
ENCOURAGING.
>> I THINK WE STILL HAVE NORA
AND WALLY'S HANDS UP.
DO WE HAVE TIME.
>> WE HAVE TIME.
>> DR. VOLKOW.
>> Director Volkow: I ALSO C
CONGRATULATE YOU AND THE ONLY I
THINK TO HIGHLIGHT OVER ALL
BECAUSE IT'S SPECIFICALLY A
GREAT PRIORITY TO THE CURRENT
ADMINISTRATION IS THE NOTION
THAT CHRONIC PAIN IS A CHRONIC
CONDITION THAT IS EXTREMELY
WIDESPREAD.
AND WE NEGLECTED CHRONIC PAIN
CONDITIONS WHICH IS NEGATIVELY
IMPACTING OUTCOMES IN HEALTH IN
GENERAL IS AN OPPORTUNITY TO
BRING IT FORWARD AS ONE OF THE
CONDITIONS THAT WE NEED TO
ACTUALLY ADDRESS AS A CHRONIC
CONDITION AND AN UNFORTUNATE
CHRONIC CONDITION YOU CAN START
IN EARLY CHILDHOOD AND
THROUGHOUT AND YOU LOOK AT
HYPERTENSION AND DIABETES AND
PAIN IS A CHRONIC CONDITION AND
MAKING IT CLEARLY IN THE
NARRATIVE NOT THAT UNDERLYING
THE IMPORTANCE OF ACUTE PAIN,
BUT I ALWAYS VIEW IT TO A
CERTAIN EXTENT WITH DIFFERENT
SORT OF UMBRELLAS OF WHAT YOU
NEED TO ADDRESS.
ONE IS MORE COMPLEX THAN THE
OTHER.
YOU WANT TO BE AWARE THAT
CURRENTLY AS THIS CHRONIC
DISEASES ARE OUR PRIORITY FOR
THE ADMINISTRATION, TO MAKE
EVERYONE AWARE THAT THIS IS ONE
OF THE MOST PREVALENT CHRONIC
CONDITIONS.
>> IT'S A GOOD POINT.
VERY GOOD POINT.
I THINK WE CAN CERTAINLY WORK
ADDITIONAL WORDING INTO THE
INTRO.
>> WALLY.
>> I WAS THINKING ABOUT OUR
FEDERAL PARTNERS PCORI, CDC, FDA
AND OTHERS WHO ALSO HAVE THIS ON
THEIR AGENDA AND HOW WE
COOPERATE WITH THEM AND WONDERED
FROM WALTER AND NORA ARE YOU ALL
STILL MEETING?
IS THERE STILL THE POSSIBILITY
OF MEETING WITH THEM AROUND THIS
AREA OF PAIN SO THAT THINGS LIKE
POLICY AND WHO IS GOING TO PAY
AND HOW DO YOU DO IT CHEAPER AND
IMPLEMENTATION SCIENCE AND ALL
THE THINGS WE TALKED ABOUT
TODAY, GETTING THIS IN THE HANDS
OF CLINICIANS AND INTO THE
POLICY ARENA IS COORDINATED IN A
BETTER WAY.
>> Director Volkow: I THINK IT'S
AN EXCELLENT POINT AND RIGHT NOW
SOME OF OUR REGULAR MEETINGS ARE
ON HOLD FINALIZING WHO WILL BE
THE LEAD PERSON.
I THINK IT'S CLEAR ON EVERYONE'S
BRAIN THAT WE NEED TO CONTINUE
THE INTERACTIONS BECAUSE WE CAN
SHOW SOMETHING WORKS IF IT'S NOT
REIMBURSED BY CMS THEN IT'S NOT
GOING TO TRANSFORM INTO A CHANGE
POPULATION OUTCOME.
WE'VE COME TO REALIZE HOW
INCREDIBLY IMPORTANT IT IS TO
HAVE THIS CLOSE DIALOGUE WITH
CMS, WITH THE FDA AND WITH CDC
BECAUSE THEY'RE THE ONES THAT
ULTIMATELY TAKE THE KNOWLEDGE
AND TRANSLATE IT TO A PRODUCT
THAT WILL BE REIMBURSED OR
REIMBURSE THEM THEMSELVES.
RIGHT NOW I KNOW THE MEETINGS WE
WERE HAVING WITH THE VARIOUS
AGENCIES FROM HHS ARE PUT ON
HOLD.
WE HAVE SOME INFORMAL ONES IN
THE ARENA OF OPIOID OVERDOSES
BUT THOSE DON'T REALLY TYPICALLY
ADDRESS PAIN.
THEY ADDRESS THE OTHER ASPECTS
OF ADDICTION AND OVERDOSES.
I DON'T KNOW.
WALTER AND LINDA MAY HAVE MORE
SPECIFICS REGARDING PAIN.
OR JACKIE.
>> I'VE ALREADY MENTIONED THE
INTERAGENCY SEARCH COORDINATING
COMMITTEE BUT WILL LET LINDA SAY
A FEW THINGS ABOUT IT AS WELL.
>> Linda: WE'VE SPOKE WITH MANY
AGENCIES MENTIONS BY WAY OF THE
COORDINATING COMMITTEE.
THE MEMBER INCLUDES CDC, NOT,
CMS BUT WE'RE INVITING THEM AS
AN AD HOC MEMBER.
HELENE HAS BEEN PROMOTING
INCLUDING THEIR MEMBERSHIP.
THE FDA'S ON, THE DOD'S ON AND
V.A. IS ON.
SO, THOSE GROUPS ONLY MEET TWICE
A WEEK BUT WE HAVE TWICE A
YEAR -- WE'RE BUSY HERE.
WE DO HAVE REGULAR WORKING GROUP
MEETINGS AND ACTIVITIES THAT GO
ON IN BETWEEN THE ACTUAL MEETING
OF THAT.
THERE'S BEEN A LOT OF
COMMUNICATION WITH CMS IN THE
PAST YEAR AND SHERRY LING IS
INTERESTED IN IMPROVING THE
COMMUNICATION.
WE'VE WORKED WITH ALAN BLACKWELL
WITH -- THE BILL WAS DRAFT AND
TALKING HOW TO ENHANCE
REIMBURSEMENT AND THERE WERE
CO-CHANGES THAT HAPPENED THERE
TO INCREASE TIME AND
REIMBURSEMENT FOR ASSESSMENT OF
CHRONIC PAIN.
WE WORKED WITH THEM AND PUT
TOGETHER RESOURCES FOR HOW
PHYSICIANS IN DIFFERENT SETTINGS
COULD USE OR DIFFERENT CDE
TOOLS.
THAT'S ON OUR WEBSITE.
THERE'S A GROUP THAT MEETS WITH
CMS MONTHLY I THINK TO TALK
ABOUT RESEARCH THAT'S GOING
FORWARD.
SO THERE'S A LOT OF INTERACTION
AND I THINK IT WOULD BE ENHANCED
ESPECIALLY WITH CMS.
THAT'S A REALLY IMPORTANT
RESOURCE.
>> PCORI IS A GOOD IDEA.
>> Dr. Koroshetz: WE PUT OUT
RFAs AND THEY APPLY FOR THEM AND
THEY WIN.
>> THEY'VE STARTED INFORMALLY
JOINING THE IPRCC AS AN AD HOC
MEMBER TO BE ABLE TO
PARTICIPATE.
AND WE ARE IN THE -- IN APRIL
WE'RE STARTING WITH OUR FEDERAL
PARTNERS ON A MORE REGULAR BASIS
THROUGH THE IPRCC TO TALK ABOUT
COMMUNICATION AND DISSEMINATION
OF PAIN RESEARCH POLICY,
ETCETERA AT EACH OF THE AGENCIES
TO BE ABLE TO BECOME MORE
DIRECTLY AWARE AROUND BEING ABLE
TO CENTRALIZE THE RESOURCES.
>> I HAD A CONVERSATION WITH A
PROGRAM DIRECTOR AT ARPA-H A
COUPLE WEEKS AGO.
THEY HAVE A COUPLE PROGRAMS THEY
STARTED IN THE AREA OF PAIN
ESPECIALLY IN WOMEN'S HEALTH.
I DON'T THINK I'M SUPPOSED TO
ANNOUNCE THIS PUBLICALLY BUT
THIS ISN'T PUBLIC --
>> IT IS.
>> OKAY.
THANK YOU BOTH VERY MUCH.
THANKS EVERYONE FOR A HELPFUL
AND CONSTRUCTIVE DISCUSSION.
WE'LL TAKE THE OPINION AND ANY
ADDITIONAL INPUT WE RECEIVED AND
FURTHER THE DISCUSSION.
WE'LL DISCUSS ON OUR COUNCIL
MEETING MAY 15.
NOW I'LL PIVOT TO OUR FINAL
DISCUSSION TOPIC OF THE
AFTERNOON AND MY PLEASURE TO
INTRODUCE DR. AMY GOLDSTEIN THE
CHIEF OF THE PREVENTION RESEARCH
BRANCH IN THE DIVISION OF
EPIDEMIOLOGY SERVICES AT
PREVENTION RESEARCH AT NIDA.
SHE HAS SPENT A DECADE PRIOR TO
COMING TO NIDA SHE SPENT A
DECADE AT NIMHD WHERE SHE HELD
ROLES INCLUDING THE NIH RECOVERY
AFTER AN INITIAL SCHIZOPHRENIA
EPISODE AND NATIONAL SUICIDE
PREVENTION PROJECTS.
SHE GOT HER BACHELOR'S DEGREE IN
PSYCHOLOGY FROM WASHINGTON
UNIVERSITY AT ST. LOUIS AND
Ph.D. IN CLINICAL CHILD
PSYCHOLOGY FROM CASE WESTERN AND
COMPLETED AT JOHNS HOPKINS
SCHOOL OF PUBLIC HEALTH AND
LEADS THE RESEARCH PROGRAM.
WE APPRECIATE HER COMING TODAY
TO PROVIDE A PROGRAM OVERVIEW
AND UPDATE.
>> Dr. Goldstein: PREVENTION IS
IMPORTANT AND THERE'S SYSTEMATIC
BARRIERS TO IMPLEMENTATION AND
WE NEED TO ENGAGE KEY
STAKEHOLDERS AND THOSE ARE KEY
TAKEAWAYS.
I WANTED TO PROVIDE AN OVERVIEW
OF ALL INITIATIVES UNDER THE
UMBRELLA OF HEAL PREVENTION AND
TALK ABOUT WHERE SOME RESEARCH
IS NOW.
LOOKING BACK I THINK IT'S BEEN A
HOT LIKE TWO YEARS SINCE I
PRESENTED TO THIS GROUP.
SO A LOT'S BEEN HAPPENING SINCE
THEN.
STARTING WITH OUR GUIDING VISION
OUD VISION IS HEALTH CARE
ORGANIZATIONS AND PUBLIC SYSTEMS
ARE ABLE TO MAKE EVIDENCE-BASED
SERVICES ACCESSIBLE TO ALL WHO
RISK OPIOID OR SUBSTANCE USE
DISORDER.
IT'S MY GUIDING STAR.
WE ARE LEARNING HOW TO DO
PREVENTION OF OPIOID MISUSE BUT
THERE'S AN IMPLEMENTATION GAP.
IS EVERYONE OKAY?
>> YOU'RE GOOD.
>> Dr. Goldstein: THIS IS MY
NORTH STAR WHEN I THINK ABOUT
THE WORK WE'RE DOING WHICH IS
THE IDEA WE'RE DEVELOPING AND
TESTING INTERVENTIONS TO PREVENT
SUBSTANCE MISUSE BUT THERE'S A
BIG GAP IN IMPLEMENTING THE
PROGRAM AND HOW DO WE DESIGN
RESEARCH TO ENSURE EVERYTHING
WE'RE TESTING CAN BE IMPLEMENTED
IN THE REAL WORLD.
BY WAY OF BACKGROUND.
THE TRENDS ARE THE SAME BUT THIS
IS DATA FROM NATIONAL SERVICE ON
DRUG USE AND HEALTH FROM 2020
WHERE WE SEE ABOUT 9.5 MILLION
PEOPLE 12 AND OLDER MISUSED
OPIOIDS AND ONLY 278,000
RECEIVED TREATMENT FOR OUD.
THERE'S A LOT OF WORK AROUND
TREATMENT ENGAGEMENT AND
EFFECTIVE PREVENTION CAN WORK IN
DECREASING THE NEED FOR THE
TREATMENT PROGRAM.
SO WHEN WE LAUNCHED PREVENTION
WE TALKED ABOUT FOUR STRATEGIC
AREAS WE THOUGHT WERE IMPORTANT
IN ORDER TO DO THE WORK AND
RESEARCH AND RISK IDENTIFICATION
AND SOCIAL AND ENVIRONMENTAL
FACTORS THAT MAY PLAY A ROLE AND
IMPLEMENTATION SCALE UP AND
SUSTAINABILITY.
WE HAVE PROJECTS GOING IN ALL
THOSE SPACES RIGHT NOW.
I'M GOING TO START WHERE WE
BEGAN IN FY19.
WHEN HEAL PREVENTION LAUNCHED,
WE DID SO WITH A NOTICE FOR
ADMINISTRATIVE SUPPLEMENTS AND
ANNOUNCEMENT FOR APPLICATIONS
AND HEAL PREVENTION COORDINATING
CENTER.
OUR STARTING POINT WAS WE NEEDED
TO ESTABLISH EVIDENCE-BASED
INTERVENTIONS SPECIFIC TO OPIOID
MISUSE AND THE DEVELOPMENT OF
OPIOID USE DISORDER IN
ADOLESCENTSES AND YOUNG ADULTS
AND THE GOAL HERE WAS TO SOLICIT
RESEARCH TO DEVELOP ADAPT AND
TEST INTERVENTIONS AND STRATEGY
TO PREVENT THE INITIATION OF
OPIOID MISUSE IN ADOLESCENTS AND
YOUNG ADULTS AND HAD A
COMMUNITY-ENGAGED APPROACH AND
HAD A COMMUNITY PARTNER AND HAD
TO HAVE IMPLEMENTATION AIMS AND
AN ECONOMIC ANALYSIS.
OUR GOAL IS PRETTY BROAD IN
TERMS OF THE RANGE OF SYSTEMS
AND STUDIES AND I'LL COME BACK
BUT THIS IS WHERE WITH STARTED.
AND ONCE WE HAD THOSE PROJECTS
IN THE FIELD WE DECIDED WE
NEEDED TO PAY ATTENTION TO
CONTEXT.
ALL OUR PROGRAMS ARE INDIVIDUAL
OR FAMILY-BASED INTERVENTIONS.
BUT WHAT WE WERE FINDING WAS
CONTEXT MATTERS.
WE WEREN'T GOING TO FULLY
ADDRESS THE PROBLEM BY FOCUSSING
ON THE INDIVIDUAL ROLE BUT
NEEDED TO THINK BROADLY ABOUT
THE SYSTEMS IN WHICH PEOPLE WERE
LIVING.
SO WE LAUNCHED TWO INITIATIVES
IN FY22 AND FY23 WHICH WERE
FOCUSSED ON PREVENTING OPIOID
MISUSE AND CO-OCCURRING
CONDITIONS BY INTERVENING ON
SOCIAL DETERMINATES AND THERE'S
A REAL BROAD AWAY OF WHAT WE'RE
FINDING AND WHAT THE RESEARCH IS
DOING AND THIS IS WORK FROM
SILVIA MARTIN AND HER COLLEAGUES
FROM A SOCIAL DETERMINATES AND
ADDRESSING THE RISK FACTORS WE
KNOW GO TO OVERDOSE.
THEY WERE LOOKING AT THE
ASSOCIATION BETWEEN UNEMPLOYMENT
INSURANCE AND OVERDOSE DEATHS.
THAT COVERS THE PERIOD OF COVID
AND START OF THE COVID PANDEMIC
AND USED UNEMPLOYMENT INSURANCE
AS A WEEKLY BENEFIT ALLOWANCE
REPLACING WHICH IS THE
PROPORTION OF SOMEONE'S WEEKLY
EARNINGS FOR UNEMPLOYMENT
INSURANCE.
WHAT YOU CAN SEE HERE IS THE
DISTRIBUTION OF THE BENEFIT IN
20 14 AND 2020.
A SMALLER PERCENTAGE OF
SOMEBODY'S INCOME REPLACED BY
INSURANCE AND THIS REPRESENTS A
GREATER PERCENTAGE IN ORANGE AND
IT INCREASED OVER TIME AND WHERE
THEY PROVIDED A GREATER
PERCENTAGE OF SOMEBODY'S
COVERAGE OVERDOSES DECREASED IN
THE AMOUNT OF UNEMPLOYMENT.
AS WE THINK ABOUT RESEARCH WE
NEED TO THINK ABOUT THE
MECHANISM OF ACTION BY WHICH THE
INTERVENTIONS OR SOCIAL
INTERVENTIONS ARE EXERTING THEIR
AFFECT.
I THOUGHT IT WAS AN INTERESTING
EARLY FINDING TO COME FROM THE
RESEARCH.
WE FOCUSSED ON THE INDIVIDUAL
AND THIRD LOOKING AT SERVICES
RESEARCH.
AS CAME UP IN THE LAST SET OF
PRESENTATIONS AND DISCUSSIONS,
THERE'S AN A REAL CHALLENGE AND
THERE'S INTERVENTIONS THAT CAN
HAVE BROAD PUBLIC IMPACT BUT
DON'T HAVE EFFECTIVE PATHWAYS
FOR DELIVERING INTERVENTIONS.
THE GOAL RFAs ARE TO SUPPORT
RESEARCH AND THAT COULD BE ON
STRATEGY TO IMPLEMENT AND
SUSTAIN EVIDENCE-BASED SERVICES
IN SYSTEMS AND SETTINGS.
WE DON'T HAVE A PREVENTION
SYSTEM BUT IT'S OCCURRING IN
SCHOOLS AND JUVENILE JUSTICE AND
CHILD WELFARE AND WHAT RESEARCH
CAN WE DO TO ENHANCE THE
DELIVERY OF THE PROGRAMS IN
THOSE SETTINGS OR DEVELOP A
WORKFORCE OR INFRASTRUCTURE TO
HAVE THE SYSTEM AND SETTING BY
WHICH TO DELIVER EFFECTIVE
PROGRAMS.
THIS IS AN ACTIVE ANNOUNCEMENT.
WE HAD TWO RECEIPT DATES SO FAR
WITH A REVIEW PENDING NEXT
MONTH.
I'M EXCITING TO SEE THE RESEARCH
HAPPENING IN THIS SPACE AND
HOPEFULLY I CAN COME BACK IN A
YEAR OR SO AND GIVE AN UPDATE OF
WHAT'S HAPPENING THERE.
THAT'S WHERE WE ARE IN OUR
FUNDING INITIATIVE.
I WANT TO GO BACK TO WHERE WE
STARTED WHICH IS THE HEAL
PREVENTION COOPERATE.
THESE WERE CLINICAL TRIALS
OCCURRING IN AN ARRAY OF
SERVICES AND SYSTEM SETTINGS YOU
SEE HERE.
WE HAVE PROJECTS THAT ARE IN
HEALTH CARE SO EMERGENCY
DEPARTMENTS AND CHILD WELFARE
SYSTEM AND COMMUNITY-BASED
PREVENTION, TWO PROGRAMS
TARGETING JUVENILE JUSTICE
SETTINGS AND A COUPLE HOME-BASED
PROJECTS.
THESE ARE PRETTY DISPARATE
SETTINGS.
THERE'S OVERLAP IN TERMS OF
POPULATIONS AT RISK BUT WHAT'S
BEEN GREAT IS THEY COME TOGETHER
AS A LEARNING COOPERATE AND
TRIED TO STANDARDIZE SOME ASPECT
OF THEIR WORK.
THERE'S COMMON DATA MEASURES AND
ONCE THEY HAVE THEIR OUTCOMES
RELEASED THEY'LL HAVE A
HARMONIZED APPROACH TO
INTERVENTION COSTS.
THEY'LL BE DOING BUDGET IMPACT
IN HOUSE AS PART OF THE WORK AND
THEY'VE BROUGHT TOGETHER COMMON
DATA MEASURES.
RIGHT NOW WE DON'T HAVE THE DATA
TO REPORT.
LOOKING AT THE TIMING THE
PROJECTS LAUNCHED AROUND THE
SAME TIME AS COVID-19 PANDEMIC.
THEY HAD TO TAKE A LITTLE BIT OF
A PAUSE AND REGROUP.
HOPEFULLY IN THE NEXT COMING
MONTHS TO YEAR WE'LL HAVE
OUTCOME PAPERS.
SOME ARE INDICATED IF YOU DO
QUICK MATH YOU CAN SEE WE HAVE
SO PROJECTS.
THAT'S BECAUSE SOME OF WORK IS
TIERED INTERVENTION THERE'S AN
OVERLAY OF THE APPROACH.
REALLY MOST EFFECTIVE IN
PREVENTING OPIOID DISORDER AND
COMMUNITIES NEED TO OFFER AN
ARRAY OF SERVICES TO MEET PEOPLE
WHERE THEY ARE IN TERMS OF THEIR
NEED.
AND THERE'S RISK BEHAVIORS OR NO
KNOWN FACTORS.
I DON'T HAVE DATA BUT HAVE
BASELINE DATA TO PRESENT BECAUSE
I THINK IT TELLS AN INTERESTING
STORY ABOUT THE POPULATION AND
AS WE THINK ABOUT WHERE TO GO
FROM HERE.
THIS IS UNPUBLISHED DATA AND ALL
ARE PROCESS AND PROTOCOL.
BUT I DID ASK THE P.I.'S AT
LEAST TO SHARE THIS THE NEXT
COUPLE SLIDES WITH YOU.
I WANT RESEARCHERS TO TALK ABOUT
THIS THEMSELVES BUT IT'S
BASELINE DATA FROM THE TEN
RESEARCH PROJECTS.
WHAT I HAVE UP HERE IS A LIFE
TIME REPORTING OF PERCENT HAVING
EVER USED CANNABIS OR MISUSED
OPIOIDS.
WHAT WAS STRIKING WHEN THE DATA
WAS FIRST PRESENTED A YEAR AGO
WAS THE PREVALENCE OF CANNABIS
USE YOU CAN SEE THERE'S A COUPLE
IN THE LOW END WITH THE
REPORTING BUT THE RANGE IS MORE
IN THE 70 TO 90%.
THESE ARE INDIVIDUALS WITHOUT
SUBSTANCE USE DISORDER AGES 16
TO 30 AND SO I THINK AS A GROUP
WE WERE BLOWN AWAY HOW THE
CANNABIS WAS BEING USED AND
ADDRESS THIS IN THE RESEARCH
MOVING FORWARD.
THE OTHER THING THAT CAME OUT
WAS THE MEAN AGE OF INITIATION
FOR THOSE.
AMONG THOSE REPORTING CANNABIS
AND OPIOID MISUSE THE CANNABIS
PRECEDES THE OPIOID MISUSE AND
THERE'S A RELATIVELY SHORT
WINDOW OF TIME BEFORE SOMEONE
WHO INITIATED CANNABIS
TRANSITION TO USING OPIOIDS.
FOR SOME STUDIES IT'S A YEAR,
MAYOR TWO YEARS.
FOR ME AS I THINK ABOUT NEXT
STEPS IS THE IDEA WE HAVE A
WINDOW OF OPPORTUNITY TO
INTERVENE BEFORE SUBSTANCE USE
BECOMES POLY SUBSTANCE USE.
THE QUESTION OF PREVENTING OTHER
USE IS PREVENTING CANNABIS EARLY
ON.
TO ME IT SPEAKS TO THE NEED FOR
EARLY INTERVENTION AND THINK OF
PREVENTION OF USE TO MISUSE.
AND SOME OF THE DATA WITH THE
FACT THERE'S LARGE DATA
DEVIATION BUT IT WAS INTERESTING
TO THINK AS WE THINK ABOUT NEXT
STEPS FOR PREVENTION.
THE LAST IS INDIVIDUALS AT RISK
FOR OPIOID MISUSE AND THE
PERCENT WERE REPORTING MODERATE
OR GREATER SEVERITY AT BASELINE.
THE GREEN PAR IS PHQ DATA AND
THE BLUE IS THE GAD SETTING.
YOU SEE SUBSTANTIAL
COMORBIDITIES WITH RESPECT TO
THE POPULATION.
AS WE THINK OF INTERVENTION
DEVELOPMENT MOVING FORWARD.
I WANTED TO SHOW SOMETHING THAT
CAME UP FOR A PROJECT WE'RE
FUNDING.
THIS IS AN INTERVENTION AT
CHESTNUT HEALTH SYSTEM WORKING
WITH WELFARE INVOLVED FAMILIES
AND WHAT SHE FOUND IS THERE'S
CHALLENGING IN UPSTREAM
PREVENTION.
OFTEN THE NEED FOR TREATMENT
OUTWEIGHS THAT OF PREVENTION.
YOU NEED A BETWEEN ACCESS TO
TREATMENT AND REFERRALS.
SHE DEVELOPED A CONTINUUM OF
CARE MODEL ADAPTING A TERTIARY
PREVENTION PROGRAM TO CREATE A
MODEL THAT SPANS PREVENTION AND
TREATMENT IN ORDER TO REACH MORE
FAMILIES.
HER PROGRAM CALLED JUST CARE FOR
FAMILIES IS AN INTERVENTION FOR
FAMILIES AT RISK OR ALREADY
INVOLVED IN CHILD WELFARE AND
INVOLVES A CONTINUUM OF
SERVICES, SYSTEM NAVIGATION AND
COMMUNITY BUILDING AND PARENTING
AND ADDRESSING SOCIAL NEEDS OF
THE FAMILIES INVOLVED IN THE
SYSTEM.
THE REASON WHY I WANTED TO BRING
THIS UP IS BECAUSE IT WAS EASIER
TO IMPLEMENT AND SUSTAIN.
THE STATE HAS A FUNDING MODEL
FOR HER TO SUPPORT THE
NON-REIMBURSABLE COMPONENT
ALLOWING THE RESEARCH TO HAVE A
CHANCE OF SUSTAINING AFTER THE
RESEARCH BECAUSE SHE FOUND
SUPPORT FROM THE STATE IN WHICH
TO DO IT.
THIS IS REALLY THE WAY I'M
TRYING TO GET RESEARCHERS TO
THINK ABOUT THEIR WORK AND WHAT
HAPPENS NEXT AND HOW DO WE GET
IMPLEMENTATIONS SUSTAINED AND
IMPLEMENTED AND TAKEN TO SCALE.
THE LAST IS TO GIVE A SHOUT OUT
AND ACKNOWLEDGE THE
DISSEMINATION ACHIEVEMENTS AND
ACTIVITIES OF THE GROUP UNDER
THE DIRECTION OF RTI.
BECAUSE THE STUDIES HAVE BEEN A
BIT DELAYS BECAUSE OF COVID AND
DON'T HAVE A LOT OF OUTCOME
PAPERS THE GROUP DID A NICE JOB
OF MAKING SURE THEY WERE
COMMUNICATING GENERALLY WHAT'S
BEEN HAPPENING WITH THE HEAL
INITIATIVE AND COMING AT IT FROM
DIFFERENT ANGLES.
THEY HAD A GREAT POD SERIES
WHERE THAT ARE WE INTERVIEWING
WOMEN INVESTIGATORS AROUND THEIR
WORK IN PREVENTION SCIENCE AND
HAD MANUSCRIPTS, BLOGS, REGULAR
NEWSLETTERS TO SYSTEMATIC
REVIEWS FOCUSSED ON SOCIAL
CONNECTIONS AND ROLE ON OPIOID
MISUSE AND LOOKING AT OPIOID AND
SUICIDE AND HAVE DONE WEBINARS.
MANY CONFERENCE PRESENTATIONS.
THERE'S GREAT RESOURCES AND
INFORMATION THAT'S COME OUT
ABOUT THE INITIATIVE AS WE WAIT
FOR THE ABILITY TO PRESENT SOME
OUTCOME DATA.
IN TERMS OF NEXT STEPS, WE'RE
STARTING TO THINK ABOUT WHERE WE
WANT TO GO WITH INTERVENTION
DEVELOPMENT.
THE IDEA OF TARGETING IDENTIFIED
RISK POPULATIONS.
FOCUSSING ON SYSTEMS BASED
PREVENTION AND MEETING
INDIVIDUALS WHERE THEY ARE AND
THE STUDIES ARE TOUCHING
MULTIPLE SYSTEMS.
HOW DO WE DO A BETTER JOB OF
ENGAGING INDIVIDUALS IN MULTIPLE
SYSTEMS AND THINKING ABOUT
IMPLEMENTING ACROSS TWO SYSTEMS
INSTEAD OF ONE AND DOING
IMPLEMENTATION AND SERVICES
RESEARCH SO THE RFA HAS A REVIEW
MEETING SCHEDULED FOR APRIL.
I'M EXCITED TO SEE WHAT COMES
FROM THERE AND THERE WAS A
COMMENT ABOUT PARTNERSHIP OF
OTHER FEDERAL AGENCIES.
WE'VE HAD A LOT OF DIALOGUE WITH
SAMHSA AND TAKE WHAT WE'RE
LEARNING FROM OUR INTERVENTIONS
AND PUSHING THEM OUT TO OTHER
PROGRAMS.
HOPEFULLY THAT'S SOMETHING WE
CAN CONTINUE TO THINK ABOUT
MOVING FORWARD IN THE COMING
MONTHS.
AND THERE'S THE CHALLENGE OF
PREVENTION AND WE KNOW
PREVENTION MAKES GOOD FINANCIAL
SENSE BUT THERE'S A LOT OF
IMPLEMENTATION BARRIERS TO
PREVENTION.
WHAT I HAVE IS THE TABLE FROM
THE WASHINGTON STATE INSTITUTE
FOR PUBLIC POLICY.
FOR THOSE NOT FAMILIAR IT'S A
SEPARATE INDEPENDENT RESEARCH
AGENCY THAT THE WASHINGTONS
STATE LEGISLATURE USES TO HELP
USES AROUND IMPLEMENTATION FOR
POLICY MAKE AND DETERMINING
BENEFIT PER DOLLAR IN VARIOUS
PROGRAMS.
THIS IS AN EXAMPLE OF ANALYSIS
THEY DID IT MAKE THE POINT THEY
REVIEWED DIFFERENT PROGRAMS AND
AS AN EXAMPLE OF A PROGRAM IN
NIDA THEY FIND EVERY DOLLAR
SPENT IN THE PROGRAM THEY ARE
IDENTIFIED THREE DOLLARS IN
HEALTH AND SOCIAL SAVINGS.
THERE'S AN IDEA OVER TIME THE
INVESTMENT AND PREVENTION MAKES
SENSE FOR COMMUNITIES.
WE KNOW THIS AND HAVE PROGRAMS
BUT THERE'S A STAFF IN TERMS OF
NOT BEING IMPLEMENTED.
I SPENT A LOT OF TIME THE LAST
COUPLE YEARS GOING OUT TO
COMMUNITIES AND TALKING TO RS
FROM THE NATIONAL PREVENTION
NETWORK, ON THE GROUND PROVIDERS
AND PREVENTION SERVICES TO LEARN
WHAT BARRIERS ARE.
I'VE LISTED THEM HERE.
THERE'S LIMITED FUNDING FOR
PREVENTION AND MANY ARE
IMPLEMENTED THROUGH GRANTS.
SO ONCE THE GRANT ENDS, THE
PROGRAM ENDS.
THERE'S A LACK OF WORKFORCE AND
PROGRAMS ARE NOT UNIVERSALLY
ACCESSIBLE AND DON'T HAVE A GOOD
TRACKING SYSTEM TO UNDERSTAND
WHAT'S GOING ON WITH PREVENTION.
TAKING THIS TOGETHER NIDA
CHAMPIONED BY NORA VOLKOW AND
SAMHSA AND CDC SUPPORTED A
NATIONAL ACADEMIES STUDY FOR
BEHAVIORAL HEALTH DISORDERS.
THIS WAS LAUNCHED IN DECEMBER OF
'23 AND IT WAS AN AD HOC
COMMITTEE TO DEVELOP A BLUEPRINT
FOR DELIVERING PREVENTION
INTERVENTIONS FOR BEHAVIORAL
HEALTH DISORDER.
WE TASKED THE COMMITTEE FOR BEST
PRACTICES WHAT THAT WOULD LOOK
LIKE AND WHAT THE FUNDING NEEDS
AND STRATEGIES ARE AND
ACTIONABLE RECOMMENDATIONS IN
ORDER TO IMPLEMENT
INFRASTRUCTURE SO WE CAN ADDRESS
THIS RESEARCH TO PRACTICE GAP.
AND I'M EXCITED TO SAY THE
REPORT IS DUE TO US IMMINENTLY
AND THAT WILL BE A REAL HELP IN
ADDING TO LIKE HOW WE THINK OF
DOING PREVENTION RESEARCH MOVING
FORWARD.
THIS IS JUST WHAT WE ASKED FOR
IN THE BLUEPRINT AND HAVE ASKED
FOR AN OUTLINE TO MAKE
PREVENTION AFFORDABLE,
ACCESSIBLE AND AVAILABLE TO ALL
WHO MAY BENEFIT.
WE'LL READ THE REPORT SOON AND
USE IT TO THINK THROUGH OUR NEXT
STEPS BOTH FOR HEAL PREVENTION
AND PREVENTION WRIT LARGE.
THESE ARE THE PEOPLE ON THE
GROUND HELPING US PREVENT OPIOID
USE DISORDER.
I KNOW I COVER A LOT OF GROUND
IN NOT A LOT OF TIME BUT HAPPY
TO TAKE QUESTIONS OR ADDRESS THE
PROGRAMS I MENTIONED SO FAR.
>> Dr. Koroshetz: TO MAKE A
LARGER IMPACT THIS IS THE WAY TO
GO.
>> Dr. Goldstein: THANKS.
THERE'S A QUESTION FROM ERIC.
>> THANK YOU FOR THE EXCELLENT
PRESENTATION.
I WAS CURIOUS ABOUT THE PASSING
COMMENT ABOUT WORKING WITH
SAMHSA WITH THE DISCOVERIES VIA
THE BLOCK GRANTS TO THE STATES.
I WAS HOPING YOU CAN SPEAK MORE
TO THAT.
THAT'S EXCITING.
>> IT'S BEEN REALLY EXCITING FOR
THE LAST THREE YEARS I'VE HAD A
BIWEEKLY PHONE CALL TO THINK
ABOUT HOW WE DO A BETTER JOB OF
GETTING EVIDENCE-BASED
INTERVENTIONS IN THE HANDS OF
COMMUNITIES.
WE HAVEN'T FULLY FIGURED IT OUT
YET BUT HAVE IDEAS WHAT WE CAN
DO.
SAMHSA HAS BEEN A PARTNER AROUND
THE INFRASTRUCTURE STUDY AND
TALKING ABOUT DIFFERENT GRANT
MECHANISMS.
WE HAVE A HEAL PREVENTION
MEETING OF INVESTIGATORS AND HAD
SAMHSA LEADERSHIP AT OUR MEETING
LAST APRIL TO HEAR ABOUT THE
PROJECTS AND THINK WHAT MIGHT
MAKE SENSE FOR THE SAMHSA FUNDED
COMMUNITY.
THEY HAVE A LOT OF IDEAS AND
GETTING CLOSER TO EXECUTION BUT
HOPEFULLY WE CAN DO A BETTER JOB
OF MAKING SURE THE PROGRAM IS
RECEIVING DOLLARS THAT IS
EVIDENCE-BASED.
>> SUPER IMPORTANT.
>> IT'S A NECESSARY NEXT STEP TO
TURN HEAL INTO A REDUCTION OF
MORALITY AND MORBIDITY RELATED
TO ADDICTION SO THANKS A LOT.
>> Dr. Goldstein: THANK YOU.
WALLY.
>> I WAS STRUCK BY THE
INVESTIGATORS WHO THEN WENT ON
TO GET SPLN TO PAY TO GET THE
INTERVENTION AND PRACTICE AND
STRUCK BY THE MODEL AND THAT IT
STILL ALLOWED THOUGH I REMEMBER
WAY BACK WHEN THE WHEEL CHAIR
BOUND PERSON WHO NEED ED BREAST
CANCER CHEMOTHERAPY AND IT
WASN'T COST EFFECTIVE AND THEY
WHEELED THE PERSON IN TO SAY
YOUR METRICS ARE NOT GOOD BUT IT
SEEMS THEY SURVIVED THE FIASCO
AND STILL OUT THERE SHOWING
THESE COST EFFECTIVENESS
MEASURES OR COST BENEFIT RATIOS.
I WANTED TO HEAR A LITTLE BIT
ABOUT BOTH OF THOSE AND WHERE
OTHER STATES ADOPTED IT.
>> THAT'S A GREAT QUESTION.
>> THEY PRESENTED TO THE
NATIONAL ACADEMIES.
WASHINGTON STATE I HAD A LOT OF
CONVERSATIONS WITH FOLKS IN
WASHINGTON STATE BECAUSE THEY
HAVE A GREAT EXAMPLE OF ACADEMIC
PRACTITIONER PARTNERSHIPS AND
REPRESENT WASHINGTON HAS BEEN
GREAT IN TERMS OF WHAT
ADAPTATIONS HAVE TO HAPPEN AND
HOW TO GET IT PAID FOR.
AND HOW TO USE MONEY
THOUGHTFULLY AND FOCUSSED ON
INTERVENTIONS AND ALSO DONE IN
PARTNERSHIP WITH THE DEVELOPERS
TO STAY IN TOUCH WITH WHAT IS
EVIDENCE-BASED.
IT'S AN EXAMPLE TO SEE.
PENNSYLVANIA IS ANOTHER GOOD
EXAMPLE OF ACADEMIC PAR NERSHIPS
AND HAVING CENTERS THAT WANT TO
IMPLEMENT THE RESEARCH AND
STUDYING AND MAKING SURE
EVIDENCE-BASED INTERVENTION IS
HAPPENING AND HAPPY TO FOLLOW-UP
AND POINT YOU IN THOSE
DIRECTIONS AND LISA SALDANA IS
IN OREGOREGON.
I DON'T KNOW HOW IT UNFOLDED.
I'M HAPPY TO HAVE THAT
CONVERSATION TOO BUT SHOWING THE
IMPACT OF HER CONTINUING CARE
MODEL GOT STATE FUNDING TO
PERSIST WITH HER WORK.
THERE'S A COUPLE EXAMPLES OF
THAT THAT HAPPENED OVER TIME
TOO.
IT'S HAPPENING.
IT'S JUST NOT AS WIDESPREAD.
>> Dr. Koroshetz: WE TALK ABOUT
PEOPLE WITH LIVED EXPERIENCE AND
ADOLESCENTS IS A DIFFERENT
GROUP.
DO YOU BRING IN KIDS INTO THE
PROGRAMS AND HAS THAT BEEN TRIED
AND HELPFUL?
>> Dr. Goldstein: WE'RE TRYING
TO FOCUS MORE AND HAVE A COUPLE
GRANTS ON YOUTH ENGAGEMENT AND
RESEARCH.
WE'RE TRYING TO DO MORE OF THAT.
I HAVE A HIGH SCHOOL STUDENT IN
MY HOUSE I TALK TO ABOUT SOME OF
THIS STUFF BUT AT A BROADER
LEVEL WE'RE TRYING TO GET THE
YOUTH PERSPECTIVE IN THE WORK
BECAUSE OFTEN THERE'S A
DISCONNECT ON WHAT INVESTIGATORS
THINK WILL RESONATE WITH YOUTH
AND WHAT RESONATES WITH YOUTH SO
WE'RE TRYING TO DO MORE OF THAT.
>> Dr. Koroshetz: THANKS.
>> Director Volkow: WE HAVE NOT
FOCUS THE THAT MUCH ON
ADOLESCENCE TO ADULTHOOD AND
WE'RE TRYING TO REMEDY IS AND
WHAT ARE THE PRIORITIES AND HOW
WILL THEY RESPOND AND WHAT IS
THE MOST VALUABLE FOR RESEARCH
AND NEVER HAD THE CONVERSATION
WITH YOUNG PEOPLE.
IT'S ABOUT TIME WE DO AND TRYING
TO ALEIF IATE THAT NEGLECT.
-- ALLEVIATE THAT NEGLECT.
I SEE A MESSAGE FROM GAIL.
ARE YOU WORRIED ABOUT THE GRANTS
FROM SAMHSA?
DO YOU WANT TO ANSWER?
>> Dr. Koroshetz: DON'T ANSWER.
>> YOU'LL HAVE OTHER
OPPORTUNITIES TO OFFER
PREVENTION WORK IN THE COMMUNITY
THROUGH YOUR AGENCY AND THE
MONEY ALLOTTED.
WE'RE HOPING TO -- YOU'RE DOING
GREAT WORK AND KNOW THIS IS
REALLY WHERE IT BEGINS AND THANK
YOU AND HOPE YOU CONTINUE TO
HAVE THREES OPPORTUNITIES AND
CONTINUE IN THE FUTURE.
ARE YOU PRETTY POSITIVE ABOUT
THAT IN TERMS OF THOSE TYPES OF
RO1s OR THOSE YOUR CONTINUING.
ARE THOSE AN OUTSTANDING
ANNOUNCEMENT?
>> THE PREVENTION SERVICES IS A
STANDING ANNOUNCEMENT.
THE UG3, IH3 IS A ONE-TIME
RECEIVE DATE IN 2019 BUT THE
RESEARCH ANNOUNCEMENTS THE RO1
HAS I WANT TO SAY MAYBE TWO MORE
RECEIVE DATES.
>> THANK YOU, VERY MUCH.
>> Director Volkow: EVERYBODY
COMPLAINS I'M TOO MUCH OF AN
OPTIMIST BUT IN TERMS OF THE
PRIORITY OF THE ADMINISTRATION
TO IMPROVE HEALTH AND HOW
DESPITE ALL THE BIG ADVANCES AND
THE LIFE EXPECTANCY OF AMERICANS
IS MUCH LOWER AND YOU HEARD THE
HHS SECRETARY PRESENT.
I THINK WITHIN THAT CONTEXT IT'S
CLEAR WE CRUCIAL WE DO
PREVENTION AND THE WHOLE CONCEPT
OF CHRONIC DISEASES.
YOU HAVE TO HAVE PREVENTION.
I'M OPTIMISTIC THERE'S
REPRESENTATION RESEARCH NOT JUST
PREVENTION SCIENCE BUT ALSO FOR
TRANSLATING THAT PREVENTION INTO
SUSTAINABLE INTERVENTION THAT
WE'RE NAVIGATING.
IT'S THEY'RE NOT BEING TAKEN UP.
HOW DO WE DO THAT IN A MORE
EFFECTIVE AND SUSTAINABLE WAY
I'M OPTIMISTIC THAT IS SOMETHING
FOR WHICH RECEPTIVENESS.
>> OKAY.
I THINK THAT BRINGS US TO THE
CONCLUSION OF OUR MEETING.
I DON'T TO THE, WALTER OR NORA
IF YOU HAVE CONCLUDING TALKS
ABOUT I TALK ABOUT OUR NEXT
MEETING?
>> Director Volkow: WHAT I'D
LIKE TO SAY IS THANK EVERYONE
FOR THEIR PARTICIPATION AND
INTERESTING QUESTIONS AND THE
PRESENTATIONS AND ALL THE WORK
YOU'VE DONE BEHIND THE SCENES.
IT'S PART OF THE MDWG AND THE
NIDA STAFF AND RECOGNIZING HOW
IMPORTANT THAT WORK IS AND I'M
VERY APPRECIATE IIVE WE SEE THE
EFFORTS PAYS AND SEEING BIG
ADVANCES AND FINALLY THERE'S A
CRYSTALLIZATION OF THE WORKFORCE
BEHIND PAIN RESEARCH AND SCIENCE
AND THE RECOGNITION THAT THIS IS
AN AREA THAT DESERVES ATTENTION
AND CRUCIAL FOR WELL BEING.
I'M GRATEFUL FOR WHAT YOU DO AND
GRATEFUL FOR THE PARTNERSHIP
IT'S ENABLED US TO HAVE WITH
NINDS AND THE OTHER INSTITUTES.
HAVING SAID THAT I WILL LET
WALTER AND BEFORE I LET YOU GO
SPEAK, WALTER, I LOVE THE
NEURONS BEHIND YOU IN YOUR
GLASS.
YOU HAVE NEURONS EVERYWHERE
INSIDE AND OUTSIDE YOUR BRAIN.
>> Dr. Koroshetz: SOMETIMES THEY
ESCAPE.
I FEEL EXHAUSTED LOOKING BACK AT
WHAT WE DID AND GREAT
RECOMMENDATIONS AND YOU PAT
YOURSELF ON THE BACK AND IT
LASTS 30 SECONDS AND THEN YOU
HAVE TO REALIZE, OKAY, WE HAVE
TO GET TO WORK.
WE HAVE A LOT OF PROBLEMS.
THESE PROBLEMS ARE NOT THINGS WE
MADE UP AND NOT GOING AWAY
UNLESS WE FIX THEM.
I APPRECIATE EVERYBODY'S EFFORTS
TO KEEP PUSHING THE ENVELOPE AND
SEE WHAT WE CAN DO TO SOLVE THE
PROBLEM WE GOT ASSIGNED TO FIX.
THANKS EVERYBODY FOR YOUR HELP.
>> I'M NOT SURE IF I'M GOING TO
BE IN THE FIRST GROUP REPLACED
BY NEW PEOPLE BUT JUST IN CASE
THAT HAPPENS --
>> Dr. Koroshetz: WE REPLACED
HIM ALREADY.
>> THANK YOU SO EVERYONE IN MY
WORK THE LAST FEW YEARS.
I CONSIDER THIS ONE OF THE MOST
IMPORTANT COMMITTEES I'VE WORKED
ON.
PROGRESS HAS BEEN REMARKABLE AND
I LOOK FORWARD TO CONTINUED
SUCCESS AND I'M NOT GOING
ANYWHERE AND YOU HAVE MY E-MAIL
ADDRESS.
I'M NOT SHY, I THINK YOU KNOW
THAT SO REACH OUT.
I LOOK FORWARD TO BUMPING
EVERYBODY IN THE FUTURE.
TAKE CARE.
>> Dr. Koroshetz: WE'RE ALL
TOGETHER FOR THE NEXT MEETING.
>> IT'S APRIL 29.
I WANT TO TAKE A MOMENT AND MAKE
SURE EVERYBODY CAN PUT THAT ON
YOUR CALENDAR.
WE'LL FOLLOW UP WITH THE
CALENDAR.
ON THAT NOTE, IN ADDITION TO
LINDA'S IMPENDING REQUIREMENT --
I WANT TO ACKNOWLEDGE THE
RETIREMENT OF DOUG KRAMER AND
FOR ALL THE WORK YOU HAVE DONE.
I WANT TO APPRECIATE THE WORK OF
LINDY WOODS TO MY LEFT FOR ALL
OF HER AMAZING WORK MAKING SURE
THIS MEETING KEPT ON KEEPING ON
EVEN IN THE FACE OF SOME
UNPRECEDENTED CHALLENGES OVER
THE PAST FEW MONTHS AND ALL THE
STAFF AT NIDA AND NINDS AND MAKE
IT POSSIBLE FOR US TO HEAR
HELPFUL GUIDANCE AND INDIVIDUAL
INPUT FROM MEMBERS.
THANK YOU ALL SO MUCH.
>> Dr. Koroshetz: CAN I ADD ONE
THING --
>> I LOOKED AT THAT THE 29th IS
THE BEGINNING OF THE AMERICAN
U.S. A.P.S. PAIN MEETING.
>> YES, WE ARE AWARE AND IT IS
UNFORTUNATE BUT WE'RE HOPING
PEOPLE CAN FIT IT IN AS PEOPLE
TRAVEL TO THEIR MEETING.
>> I'LL DO MY BEST.
>> WE BELIEVE IN YOU, ALLAN.
>> THANKS.
>> THANK YOU ALL VERY MUCH.
I LOOK FORWARD TO SEEING ALL OF
YOU AT THE END OF APRIL.