I'M GEORGE KOOB, I'M THE
DIRECTOR OF THE NATIONAL
INSTITUTE ON ALCOHOL ABUSE AND
ALCOHOLISM.
THIS IS THE 11th JOINT MEETING
OF THE NATIONAL ADVISORY
COUNCILS.
IT'S THE 10th MEETING OF THE
COLLABORATIVE RESEARCH ON
ADDICTION NIH FONDLY KNOWN AS
CRAN.
OKAY.
SO WELCOME TO THIS 11th MEETING
OF OUR COUNCILS AND CRAN.
WHAT I'D LIKE TO DO FIRST IS
HAVE THE INDIVIDUALS WHO ARE
HERE IN PERSON FROM OUR
RESPECTIVE COUNCILS TO INTRODUCE
THEMSELVES.
I THINK WE'LL START ON THE LEFT
WITH MICHAEL LEWIS AND THEN JUST
MOVE AROUND THE TABLE AND THEN
THOSE OF YOU ONLINE, WE'RE NOT
GOING TO GO THROUGH AN ONLINE
INTRODUCTION, BUT WE CAN SEE
YOUR FACE AND WE CAN SEE YOUR
NAME AND YOU HAVE A LISTING OF
THE COUNCIL MEMBERS WHO ARE
PARTICIPATING.
SO WE'LL START WITH MICHAEL
LEWIS AND MICHAEL?
>>GOOD MORNING.
I'M MICHAEL LEWIS, I'M PROFESSOR
OF PSYCHOLOGY AT HUNTER COLLEGE
CITY UNIVERSITY OF NEW YORK.
NIAAA COUNCIL AND I'M INTERESTED
IN ALCOHOL FEEDING AND NUTRITION
AS THEY RELATE TO PROBLEMS OF
THE DEPENDENCE WITH ALCOHOL.
>>GOOD MORNING.
I'M DIRECTOR OF THE INDIANA
ALCOHOL RESEARCH CENTER AND MY
OWN INTERESTS ARE IN THE AREA OF
BRAIN IMAGING OF RISKS FOR
ALCOHOL USE DISORDER.
>>I'M TINA CHAMBER,
EPICHEMOOLOGIST AT THE
UNIVERSITY OF CALIFORNIA SAND
DIEGO AND MY WORK IS IN FETAL
AND CHILD DEVELOPMENT.
>>PROFESSOR IN BEHAVIORAL AND
SOCIAL SCIENCES.
I STUDY ALCOHOL MISUSE AMONG
ADOLESCENTS AND YOUNG ADULTS
WITH A FOCUS ON PEER INFLUENCE
BY STANDARD BEHAVIOR AND SOCIAL
NETWORKS.
I ALSO STUDY ALCOHOL BIO
SENSORS.
>>I'M THE AAA COUNCIL AND I'M
ALSO CHIEF OF THE AAA.
>>I'M THE SGOOD MORNING. I'M
VOLKOW.
I'M DIRECTOR OF THE NATIONAL
INSTITUTE ON DRUG ABUSE.
IT'S A PLEASURE TO BE HERE WITH
MY COLLEAGUE DR. GEORGE KOOB AND
WE ARE BRINGING TOGETHER BOTH
OUR COUNCIL AND IT'S THE FIRST
TIME WE WORK TOGETHER.
WITH THAT I'M GOING TO TURN IT
DOWN TO MY RIGHT.
>>WILSON COMP STON NATIONAL
DIRECTOR ON DRUG ABUSE.
>>SUSAN WEISS, NATIONAL
INSTITUTE ON DRUG ABUSE AND
EXECUTIVE SECRETARY FOR COUNCIL.
>>GOOD MORNING.
I'M FROM WASHINGTON UNIVERSITY
IN ST. LOUIS AND MY INTERESTS
ARE IN GENETICS AND NEUROSCIENCE
OF ALCOHOL OPIOIDS AND CANNABIS.
>>GOOD MORNING.
I'M AT THE UNIVERSITY OF
PENNSYLVANIA IN THE DEPARTMENT
OF PSYCHIATRY.
I DO BRAIN IMAGING AND ADDICTION
LOOKING FOR SUBSTRATES OF
RELAPSE VULNERABILITY AND SOME
MEDICATION DEVELOPMENT WHEN IT
WORKS.
>>GOOD MORNING.
I'M SHELLY GREENFIELD.
I'M AN ADDICTION PSYCHIATRIST
AND PROFESSOR OF PSYCHIATRY AT
HARVARD MEDICAL SCHOOL.
I'M INTERESTED IN GENDER
DIFFERENCES IN SUBSTANCE USE
DISORDERS AND ALSO TREATMENT FOR
SUBSTANCE USE DISORDERS ALONG
WITH DISSEMINATION.
>>GOOD MORNING.
I'M AT THE UNIVERSITY OF SCHOOL
OF MEDICINE, PROFESSOR OF
PSYCHIATRY, NEUROSCIENCE AND
CHILD STUDY AND MY WORK IS ON
STRESS AND ALCOHOL AND SUBSTANCE
DISORDERS FOCUSING ON ADDICTION
RISK AND RELAPSE AND TREATMENT
OUTCOMES DURING IMAGING, OTHER
PHYSIOLOGICAL MEASURES AND
CLINICAL TRIALS TO ADDRESS
STRESS REDUCTION WITH ADDICTION.
THANKS.
>>OKAY.
SO WELCOME, EVERYONE.
WELCOME EVERYONE, ONLINE.
MY DEPUTY IS GETTING OVER A COLD
SO DO YOU WANT TO JUST SAY HI?
>>HI, GOOD MORNING, EVERYBODY.
I DECIDED TO STAY HOME AND SHARE
MY GERMS ONLY WITH MY FAMILY
INSTEAD OF ALL OAF YOU, BUT I'M
GLAD TO BE HERE.
SORRY NOT TO BE IN PERSON TODAY.
>>THANKS, TRISH.
>>OKAY.
SO I THINK WE'RE ON SCHEDULE AS
THE BRITS SAY, SO I THINK WE'LL
JUST MOVE TO MY PRESENTATION
UNLESS THERE'S ANY OTHER
BUSINESS.
OKAY.
SO IF YOU PUT THE SLIDES UP,
JOHN, WHICH YOU DID, AND SO THE
FIRST THING I WANT TO SAY IS
WHAT A PLEASURE IT'S BEEN
WORKING WITH NORA AND NIDA OVER
THE LAST NINE YEARS.
IT
IT'S NINE YEARS SINCE I DID MY
FIRST CRAN MEETING AND I DON'T
KNOW WHY BUT I'M FEELING EXI--
TODAY MOSTLY BECAUSE OF THE LOSS
OF MY FRIENDS.
ABE WAS RESPONSIBLE FOR
EXTRAMURAL GRANT AND CONTRACTRY
VIEW, THE MANAGEMENT OF CHARTER
REVIEW GROUPS AND SPECIAL
EMPHASIS PANELS AND ALL GRANTS,
MANAGEMENT ACTIVITIES.
HE SERVED AS EXECUTIVE SECRETARY
OF NIAAA'S ADVISORY COUNCIL AND
WAS RESPONSE L FOR OVERSEEING
AND COORDINATING COMMENDING
MANAGEMENT ACTIVITIES INCLUDING
FEDERAL ADVISORY COMMITTEES.
HE CLAIMS IN HIS RETIREMENT THAT
HE'S LOOKING FORWARD TO
EXPANDING HIS TRAVELS AND
FINDING OTHER EXCITING WAYS TO
FILL HIS DAYS BUT HE WILL BE
MISSED AND I THINK YOU ALREADY
KNOW THE ACTING OFFICE OF
EXTRAMURAL ACTIVITIES DIRECTOR
AND RV SRINIVAS IS SERVING AS
EXECUTIVE SECRETARY FOR THE
NIAAA DOWCOUNCIL.
LOTS OF THANKS FOR STEPPING UP.
ONE OF THE MAJOR LOSSES THAT
OCCURRED IN THE ALCOHOL FIELD
VERY RECENTLY WAS GORDAS, HE
SERVED AS NIAAA DIRECTOR FROM
1986 TO 2001.
HE EMPHASIZED SCIENCE AS A WAY
OF UNDERSTANDING ALCOHOL USE
DISORDER.
HE TRAINED IN INTERNAL MEDICINE.
HE CONDUCTED RESEARCH.
DR. ROSALYN DURING HIS RESIDENCY
IN MOUNT SINAI HOSPITAL IN NEW
YORK.
HE DID SOME RESEARCH IN THE
ROCKEFELLER UNIVERSITY WHERE HE
BEGAN HIS CAREER IN THE STUDY OF
ADDICT
ADDICTION.
AND LATER, HE WORKED WITH
PSYCHIATRIC RESEARCHER DR. RUTH
FOX WHO HELPED INTRODUCE A
MEDICATION.
YOU PROBABLY DONE KNOW HOW MUCH
A HAND HE HAD IN MEDICATION
DEVELOPMENT BUT HE WAS A
VISIONARY IN THAT REGARD.
HE FOUNDED A NEW ALCOHOL
TREATMENT PROGRAM IN QUEENS NEW
YORK.
HE REMAINED THERE UNTIL HIS
APPOINTMENT TO AIAAA.
HE IS REMEMBERED AS A VISIONARY
LEADER DURING HIS TENURE.
AS DIRECTOR HE OVERSAW THE
LAUNCH OF SEVERAL RESEARCH
INITIATIVES INCLUDING THE
COLLABORATIVE STUDY ON THE
GENETICS OF ALCOHOLISM.
THE NATIONAL LONGITUDINAL
EPIDEEM LOGIC STUDY AND THE
COMBINING THERAPIES AND CLINICAL
STUDY.
HIS LEADERSHIP IS EMBODIED BY
HIS LOVE OF SCIENCE, HIS
COMPASSION AS A CLINICIAN AND
HIS DEMEANOR AS A GENTLEMAN.
HE INSPIRED MANY AND LEFT A
LASTING IMPACT ON NIAAA, NIH AND
THE ALCOHOL RESEARCH FIELD.
I REALLY CONSIDERED E-NOCH A
MENTOR, A ROLE MODEL, SCHOLAR
AND PARTICULARLY A GENTLEMAN AND
THOSE OF YOU KNOW HE SPONSORS
THE GORDIS AWARDS AT RSA WHICH
HAVE TAKEN ON A REALLY SALIENT
ROLE IN -- FOR YOUNG PEOPLE.
THE AWARD EE AND THE RUNNER UP
AND HAVE THEIR POSTERS YOU KNOW,
EVALUATED AND ENOCH USED TO GO
TO ALL OF THESE FOR YEARS AND
YEARS AFTER HE RETIRED.
AND HE ALSO PARTICIPATED IN MANY
OF OUR ACTIVITIES LIKE THE
MENDELSON LECTURE AT NIH.
SO HE'LL BE SORELY MISSED AND IT
JUST MARKS A MAJOR CHANGE IN ONE
GENERATION IS MOVING ON TO
ANOTHER GENERATION SO TO SPEAK.
NEXT SLIDE.
SO I'M NOT GOING TO BORE YOU
WITH THIS BUT I JUST WANT TO
REMIND YOU THAT THE DSMV WHICH
INCORPORATES THE 11 CRITERIA AND
BASICALLY A MERGE OF THE
CRITERIA OF THE OLD ABUSE
CRITERIA AND DEPENDENCE CRITERIA
ESTIMATES THAT USING THAT METRIC
THERE ARE 29 MILLION INDIVIDUALS
WITH ALCOHOL USE DISORDER IN THE
UNITED STATES.
AND THERE ARE A NUMBER OF
EMERGENCY DEPARTMENT VISITS AND
DEATHS THAT ARE ASSOCIATED WITH
ALCOHOL.
I MEAN, YOU'VE ALL HEARD ME SAY
THIS BEFORE BUT IF YOU GO INTO
ANY MAJOR EMERGENCY ROOM AT ANY
MAJOR MEDICAL CENTER IN THE
UNITED STATES, AND I UNDERSTAND
IT'S ALSO TRUE IN CANADA, ON A
FRIDAY OR SATURDAY NIGHT, HALF
THE PEOPLE THERE ARE BECAUSE OF
ALCOHOL ONE WAY OR ANOTHER.
THE NEXT SLIDE.
AND AARON WHITE JUST PUT THIS
TOGETHER, BUT YOU CAN SEE WHAT
WE WILL CALL PROBABLY WILL CALL
IN ULTIMATELY THE PANDEMIC SURGE
IN ALCOHOL RELATED DEATHS.
THESE ARE ACTUAL DEATHS THAT ARE
LISTED ON THE CERTIFICATE AND
ALCOHOL RELATED.
AND YOU CAN SEE THERE WAS A HUGE
INCREASE BETWEEN 2019 AND 2020
AND SUSTAINED IN 2021 AND LOOKS
LIKE FINGERS CROSSED, THAT
THINGS ARE STARTING TO GO BACK
DOWN AND THIS IS NOT UNUSUAL I
MIGHT POINT OUT, THAT THESE KIND
OF SURGES IN ALCOHOL DEATHS HAVE
BEEN ASSOCIATED WITH OTHER MAJOR
EVENTS LIKE 9/11 AND HURRICANE
KATRINA AND OTHER THINGS IN OUR
SOCIETY, SO IT SPEAKS TO THE
SOCIAL DETERMINANTS AND SOME OF
THE OTHER THINGS WHICH I'LL
TOUCH ON IN A FEW MINUTES.
NEXT SLIDE.
AND YOU KNOW, ONE IN SIX
ALCOHOL -- OPIOID OVERDOSES
INVOLVE ALCOHOL.
IT'S ABOUT 15% AND YOU CAN
PARALLEL THE LINE OF INCREASES
IN DEATHS ASSOCIATED WITH
OPIOIDS WITH THE DEATHS
ASSOCIATED WITH ALCOHOL AND
OPIOIDS. THEY GO IN PARALLEL
AND THIS INDEED MAY BE AN
UNDERESTIMATION.
NEXT SLIDE.
AND SPEAKING OF WHICH, I WAS
INVITED TO PARTICIPATE WITH NORA
AND LARRY AT THE RX AND ILLICIT
DRUG SUMMIT LAST MONTH AND I
JUST WANT TO HIT FOUR QUICK
BULLETS.
THE OPIOID CRISIS OVERLAPS WITH
OTHER PUBLIC HEALTH CHALLENGES
SUCH AS UNDERTREATED CHRONIC
PAIN.
AND PAIN CONTRIBUTES TO ALCOHOL
MISUSE THROUGH DRINKING TO COPE.
AS MANY OF YOU KNOW THERE ARE
OVERLAPPING BRAIN MECHANISMS IN
CHRONIC PAIN, OPIOID USE
DISORDER.
A DETAILED UNDERSTANDING
PROVIDES AN OPPORTUNITY FOR
PREVENTING AND TREATING THESE
PROBLEMS.
ADDRESSING ALCOHOL MISUSE WITH
CHRONIC PAIN MAY HELP IMPROVE
PATIENT OUTCOMES.
ALL MY ANECDOTAL DATA FROM MY
PHYSICIAN FRIENDS TELL ME THAT
PEOPLE ARE DRINKING EVEN THOUGH
THEY SIGN AN AGREEMENTS NOT TO
DRINK WHEN THEY'RE UNDER PAIN
TREATMENTS, THEY'RE DRINKING AND
THEY'RE DRINKING MORE FOR THE
FACT THAT OPIOIDS ARE LESS
AVAILABLE.
SO THIS IS A PHENOMENON THAT HAS
BEEN GROWING FOR SOME TIME.
NEXT SLIDE.
SO I'M NOT GOING TO GO THROUGH
ALL OF THESE THIS GREAT DETAIL.
DON'T PANIC.
I ONLY HAVE A FEW MORE SLIDES,
BUT THIS IS MY MESSAGE FOR THE
YEAR.
I'LL REPEAT THIS TALK A LITTLE
MORE EXPANDED AT COLLEGE ON THE
DRUG DEPENDENCE AND CERTAINLY ON
THE MEETING, BUT WE'VE NOTICED A
MAJOR CHANGE IN THE CONVERSATION
AROUND ALCOHOL.
THERE'S INCREASING KNOWLEDGE
ABOUT THE HARMFUL EFFECTS OF
ALCOHOL. THERE'S RETHINKING
DRINKING IN U.S. CULTURE.
THERE' PROMOTING DEFERAL TO
TREATMENT AS PART OF ROUTINE
HEALTH CARE.
THERE'S SUPPORTING RESEARCH FOR
ALCOHOL USE DISORDER.
HEPATOLOGISTS ARE LEADING THE
WAY.
I'LL SHOW A QUICK SLIDE ON THAT.
I'LL SPEND A LITTLE TIME ON THE
ADDICTION NEUROCLINICAL
ASSESSMENT FRAMEWORK WHICH
BASICALLY EVOLVED FROM THE
INTRAMURAL PROGRAMS AT NIH ON
THE INDIVIDUALIZED ETIOLOGY
PREVENTION AND TREATMENT.
I'M GOING TO TALK ABOUT
SUPPORTING RECOVERY RESEARCH.
I PROBABLY WON'T SPEND TIME ON
COMBATTING STIGMA BUT WE'VE
TALKED AND WRITTEN ABOUT THAT
BEFORE, NORA AND I, AND I'LL
MENTION AT THE END,
DISSEMINATING NIAAA RESOURCES
INCLUDING THE HLT CARE
PROFESSIONAL'S CORE RESOURCE ON
ALCOHOL.
NEXT SLIDE.
I DON'T HAVE TO DWELL ON THIS.
ALCOHOL IS ASSOCIATED -- ALCOHOL
MISUSE IS ASSOCIATED WITH MORE
THAN 200 DISEASES AND INJURY
RELATED CONDITIONS.
I WOULD ARGUE THAT PROBABLY
LIVER, MENTAL HEALTH AND CANCER
ARE SOME OF THE MORE PROMINENT
ONES AND THE NATIONAL CANCER
INSTITUTE HAS BEEN WORKING WITH
US ON REALLY EMPHASIZING THE
FACT THAT 5% OF CANCER NOW IS
ATTRIBUTABLE TO ALCOHOL MISUSE.
SO IT'S A PATHOGEN WHEN YOU
ENGAGE IN IT TOO MUCH AND IT IS
A GOOD POINT -- PLACE TO SAY IT
REALLY IS NO HEALTHY AMOUNT OF
ALCOHOL.
THE J OF THE J SHAPED CURVE HAS
FLATTENED IF YOU START USING THE
APPROPRIATE CONTROL GROUPS LIKE
LOW LEVEL DRINKERS AS OPPOSED TO
NONDRINKERS AND OTHER ISSUES.
NEXT SLIDE.
AND THEN WE'VE BEEN DOING A LOT
WITH THE PRESS ON A WHOLE NUMBER
OF THINGS, BUT ONE IS I DON'T
REMEMBER HOW MANY WE DID, BUT
IT'S SOMETHING LIKE 18 PRESS
INTERVIEWS BETWEEN MYSELF AND
AARON WHITE IN JANUARY JUST ON
THIS CONSTRUCT OF DRY JANUARY.
AND WHAT WE CALL IN GENERAL THE
SOBER CURIOUS MOVEMENT.
THERE ARE DRY JANUARIES AND DRY
OCTOBERS AND DRY JANUARIES IS
QUOTE SAYS HELP US EVALUATE OUR
RELATIONSHIP WITH ALCOHOL.
IF YOU STOP DRINKING IN THE
MONTH OF JANUARY AND YOU
SUDDENLY FEEL BETTER THEN YOUR
BODY IS TRYING TO TELL YOU
SOMETHING SOLISEN TO YOUR BODY.
AND SO WE'VE BEEN VERY
SUPPORTIVE OF THESE MOVEMENTS
AND USING IT AS -- AND
LEVERAGING IT TO BASICALLY TALK
ABOUT RETHINKING DRINKING, WHICH
IS A WEBSITE THAT -- WHICH YOU
CAN ACCESS AT OUR WEBSITE WHICH
BASICALLY SAYS WHAT THIS QUOTE
SAYS.
NEXT SLIDE.
AND IT EXTENDS TO OTHER THINGS.
YOU KNOW, THERE'S A LOT OF
CONVERSATION ABOUT MOCK TAILS.
IF YOU DON'T KNOW WHAT THAT IS,
IT MEANS A COCKTAIL WITHOUT THE
ALCOHOL.
THERE ARE DRY BARS THAT ARE
CROPPING UP ALL OVER THE PLACE
IN MAJOR CITIES AND I THINK THE
GREAT ADVANTAGES THAT IT ALLOWS
PEOPLE A CHOICE.
IF THEY WANT TO DRINK THEY CAN
DRINK BUT THEY CAN HAVE FUN,
INTERACT WITH OTHERS, HAVE A DRY
SOCIAL LUBRICANT EVENING, YOU
KNOW, PATRICK KENNEDY WAS ALL
OVER ME A COUPLE OF WEEKS AGO
BECAUSE HE WAS INVITED TO BE THE
MASTER OF CEREMONIES FOR THE
SOBER ST. PATRICK'S DAY PARADE
AND HE WAS SO PROUD OF THAT AND
MANY OF YOU KNOW THAT IT'S HIS
13th YEAR.
HE'S VERY PROUD OF THAT TOO.
NEXT SLIDE.
AND THEN YOU KNOW, WE NEED TO
MOVE -- THIS IS AN EFFORT THAT
WILL BE PART -- A MAJOR PART OF
OUR STRATEGIC PLAN AND IT IS
COMING, AS THE GENTLEMAN NEXT TO
ME HAS PROMISED ME.
THE NEXT YEAR STRATEGIC PLAN FOR
NIAAA, BUT WE DO SEE A LOT OF
SCREENING IN PRIMARY CARE
OFFICES AND CLINICS, BUT WHAT WE
DON'T SEE IS THE INTERVENTION
AND WE DON'T SEE THE REFERRAL TO
TREATMENT AND THAT'S WHAT THIS
SLIDE SHOWS FROM A PAPER SHOWING
THAT SCREENING WITH LITTLE
ADVICE AND REFERRAL TO TREATMENT
FOR PEOPLE WITH ALCOHOL USE
DISORDER AND I SUSPECT THAT THIS
IS SIMILAR FOR SUBSTANCE USE
DISORDERS IN GENERAL.
SO IN ADDITION TO ITS IMPORTANT
IN PREVENTING AND INTERVENING
ALCOHOL USE DISORDER, CAREENING
AND ALCOHOL MISUSE CAN ALSO HELP
CLINICIANS SPOT OTHER HEALTH
RELATED ISSUES.
THE ALCOHOL AND SUBSTANCE MISUSE
IF I MAY SPEAK TO YOU ALL AS
WELL, IT COULD BE WINDOWS ON
OTHER PATHOLOGIES THAT ARE
SHOWING UP AT THE DOCTOR'S
OFFICE.
AND SO I THINK IT'S IMPORTANT
THAT OTHER HEALTH ISSUES IN
REVERSE CAN HELP CLINICIANS ALSO
SPOT PROBLEMS WITH ALCOHOL
MISUSE.
SO THIS IS AN AREA WE'RE PUTTING
A GOOD BIT OF ENERGY INTO.
AND THEN THE HEPATOLOGISTS ARE
HELPING US CHANGE THE
CONVERSATION AROUND ALCOHOL AND
LIVER DISEASE.
ALCOHOL MISUSE ACCOUNTS FOR
NEARLY HALF OF LIVER DISEASE
DEATHS EACH YEAR.
IT'S THE MOST COMMON ALCOHOL
RELATED CAUSE OF DEATH AND THE
LEADING CAUSE OF LIVER
TRANSPLANTATION.
ALCOHOL ASSOCIATED LIVER DISEASE
RELATED DEATHS INCREASED 47% IN
THE LAST 20 YEARS.
RATES ARE INCREASING FASTER FOR
WOMEN AND YOUNG ADULTS.
AGE 25 TO 34.
AND SO THE PARADIGM SHIFT IS
INTEGRATED TREATMENT OF ALCOHOL
ASSOCIATED LIVER DISEASE AND
ALCOHOL USE DISORDER WE FEEL CAN
IMPROVE PATIENT OUTCOMES,
TREATING ALCOHOL USE DISORDER
WITH MEDICATIONS REDUCES THE
LIKELIHOOD OF DEVELOPING ALD AND
THE PROGRESSION OF ALCOHOL
ASSOCIATION LIVER DISEASE AND
BEHAVIORAL PHARMACOLOGY -- FOR
AUD, IT REDUCES REMISSION AND
DEATH.
SO YOU CAN SEE HERE THAT ALCOHOL
ASSOCIATED LIVER DISEASE HAS NOW
SURPASSED NONALCOHOL LIVER
DISEASE IN THE GRAPH AND IT'S
BEEN STEADILY INCREASING.
YOUNG PEOPLE ARE THE SOURCE OF A
MAJOR EFFORT IN TRANSPLANTATION
NOW OF LIVER FOR PEOPLE WITH
ALCOHOL ASSOCIATED LIVER DISEASE
AND -- AND A RE-EVALUATION ALSO
OF THE CRITERIA FOR ALLOWING
LIVER TRANSPLANTATION IN
INDIVIDUALS WITH ALCOHOL
ASSOCIATED LIVER DISEASE.
NEXT SLIDE.
SO THAT'S THIS SLIDE.
SO CURRENTLY MANY U.S.
TRANSPLANT CENTERS TYPICALLY
REQUIRE A SIX MONTH PERIOD OF
ALCOHOL ABSTINENCE BEFORE THE
TRANSPLANT.
IT IS NOT REALISTIC IN HEPATITIS
WHERE THE MAJORITY OF PATIENT
DEATHS OCCUR WITHIN TWO MONTHS
OF DIAGNOSIS.
SO IF YOU HAVE TO WAIT SIX
MONTHS TO GET A TRANSPLANT
YOU'RE LIKELY TO BE DEAD, TO BE
HONEST.
SO DATA SUGGESTS THAT PATIENTS
WHO RECEIVE A LIVER TRANSPLANT
WITHOUT THE SIX MONTH WAITING
PERIOD WHICH WE CALL EARLY LIVER
TRANSPLANT HAVE SIMILAR SURVIVAL
OUTCOMES AND ALCOHOL RELAPSE
RATES AS PEOPLE WHO RECEIVE THE
TRANSPLANT.
SO TO BUILD ON THIS, NIAAA
ISSUED STUDIES TO ENCOURAGE
STUDIES ON FACTORS THAT
INFLUENCE THE SELECTION,
MANAGEMENT AND OUTCOMES OF
PATIENTS WHO RECEIVE EARLY LIVER
TRANSPLANTATION.
IN A GALAXY FAR, FAR AWAY A LONG
TIME AGO, LAURA KWAKO WHO IS NOW
DEPUTY DIRECTOR OF THE HEALTH
SERVICES BRANCH OF OUR DIVISION
OF TREATMENT AND RECOVERY
RESEARCH WAS AN INTREPID
RESEARCHER IN OUR INTERMURAL
PROGRAM AND SHE CAME UP WITH THE
HYPOTHESIS THAT MAYBE THERE
WOULD BE A WAY THAT WE COULD DO
DIAGNOSIS OF ALCOHOL USE
DISORDERS BY INCORPORATING THE
THREE STAGE ADDICTION CYCLE
FRAMEWORK AND THE DOMAINS OF
DYSFUNCTION WITHIN THE THREE
CYCLE ADDICTION FRAMEWORK.
AND SO YOU CAN THINK OF THIS AS
USING SCALES THAT MEASURE
INCENTIVE SALIENTS OR REACTIVITY
TASKS TO MEASURE INSCENTIVE
SALIENTS OR THE INVENTORY FOR
THE NEGATIVE EMOTIONALITY BUT
USING THE PSYCHOLOGICAL TESTS
AND THE SAME FOR EXECUTIVE
FUNCTION PERHAPS USING DELAYED
DISCOUNTING BUT IN ADDITION
MEASURES OF CRAVING.
AND SO SHE CAME UP WITH THE
HYPOTHESIS AND PLAN THAT THE
GOALS OF THE ADDICTIONS AND
CLINICAL ASSESSMENT ARE TO
IDENTIFY HOW THREE DOMAINS WHICH
CAN THEN GUIDE TREATMENT CENTERS
TO BETTER UNDERSTAND THE
INDIVIDUALS WITH AND WITHOUT
ALCOHOL USE DISORDER.
THIS WAS IN 2016.
IT WAS IN COLLABORATION WITH
NORA VOLKOW AND I JUST WANT TO
UPDATE YOU ON PROGRESS IN THIS
DOMAIN.
SO THE NEXT SLIDE.
AND TO BE TOTALLY TRUTHFUL THIS
WAS NORA'S IDEA.
LAURA WAS WRITING A PROTOCOL TO
DO WHAT I JUST OUTLINED FOR THE
ADDICTION CLINICAL ASSESSMENT
AND NORA SAID YOU ALREADY HAVE
PATIENTS THAT HAVE PASSED
THROUGH THE CLINICAL CENTER.
WHY DON'T YOU JUST EXAMINE ALL
THESE DOMAINS AND PREDICTORS AND
INDICATORS IN THAT GROUP OF
PATIENTS?
SO IN A LARGE DIVERSE CLINICAL
SAMPLE REPRESENTING THE SPECTRUM
OF ALCOHOL USE DISORDER THE
THREE NEUROBIOLOGICAL DOMAINS
HYPOTHESIZED TO BE CRITICAL TO
THE CYCLE WERE IDENTIFIED
THROUGH FACTOR ANALYSIS.
WE USED MEASURES OF ADISHGS,
PERSONALITY, COGNITION, BEHAVIOR
AND EXPOSURE TO EARLY LIFE
STRESS AND THEY WERE COLLECTED
IN 454 PATIENTS WHO HAD PASSED
THROUGH THE CLINICAL CENTER.
THE STUDY CONFIRMED THE
RELEVANCE OF THE THREE
NEUROFUNCTIONAL DOMAINS TO AUD
AND USING MULTIPLE CAUSES
APPROACH EARLY LIFE STRESS AND
SOCIO DEMOGRAPHIC PREDICTORS
WERE IDENTIFIED.
AND WHAT I'M GOING TO SHOW YOU
VERY QUICKLY IS THAT THIS HAS
BEEN TAKEN UP BY A NUMBER OF
RESEARCHERS IN THE FIELD AND
BASICALLY VALIDATED AND
REVALIDATED AS AN EFFECTIVE
FRAMEWORK OF WHICH TO ORGANIZE
INDIVIDUAL DIFFERENCES IN
PRECISION MEDICINE IN THE
CONTEXT OF ADDICTION.
NEXT SLIDE.
I KEEP TRYING TO CHANGE THE
SLIDE.
ANYWAY, SO HERE'S SOME
ADDITIONAL VALIDATION OF THE
THREE NEUROFUNCTIONAL DOMAINS IN
ADDICTION.
I'M NOT GOING TO SPEND A LOT OF
TIME ON THESE BUT AMONG HEAVY
DRINKERS, EXECUTIVE FUNCTION,
INCENTIVE SALIENCE,
EMOTIONALITY, POSITIVE FAMILY
HISTORY, EARLIER AGE OF FIRST
DRINK AND HISTORY OF CHILDHOOD
EMOTIONAL ABUSE AND PHYSICAL
DRINKERS, NEGLECT AS PREDICTORS
AND THIS WAS A DE-MARTNI IN
2021.
FOUR CORE CONSTRUCTS WERE
IDENTIFIED.
INVENTIVE SALIENCE, NEGATIVE
EMOTIONALITY AND EXECUTIVE
FUNCTION AND NEGATIVE ALCOHOL
RELATED CONSEQUENCES.
COMBINED WITH ANALYTIC TECHN
TECHNIQUES DOMAINS WITH
METHAMPHETAMINE USE SO THIS AN
EXTENSION TO ANOTHER DRUG OF
ADDICTION.
THIS NONTREATMENT SEEKERS, WHO
WERE UNDERGOING FUNCTIONAL MRI
AFTER ALCOHOL CUES AND NEGATIVE
CUES, FUNCTIONAL CHANGES IN THE
AMYGDALA WERE ASSOCIATED WITH
INCENTIVE SALIENCE AND NEGATIVE
EMOTIONALITY DOMAINS. AND AMONG
TREATMENT SEEKERS WITH AUD, THE
INCENTIVE SALIENCE DOMAIN SHOWED
CONSTRUCT VALIDITY AND GREATER
PREDICTIVE VALIDITY FOR DRINKING
OUTCOMES COMPARED TO PREEXISTING
SCALES AND THIS IS THE WORK FROM
STIN AND FROM HER GROUP THE
NEGATIVE EMOTIONALITY DOMAIN
SHOWED CONSTRUCT VALIDITY AND
SHOWED MORE FREQUENT AND HEAVIER
DRINKING AND DRINKING TO
REGULATE NEGATIVE AFFECT.
NEXT SLIDE.
AND SO YOU KNOW, WE WROTE A
PAPER ARGUING THAT YOU CAN ADD
TO THESE DOMAINS, PARTICULARLY
THE WITHDRAW NEGATIVE AFFECT
STAGE AND THE NEGATIVE EMOTIONAL
DOMAIN BY ENVIRONMENTAL AND
GENETIC AND EPIGENETIC INSULTS
AND THAT THIS WAS POSSIBLY
EXACERBATED BY THE ISOLATION OF
STRESS RELATED TO THE COVID-19
PANDEMIC.
SOME OF YOU HAVE HEARD ME TALK
ABOUT THIS BEFORE, BUT THAT --
THE INCREASE IN DEATHS
ASSOCIATED WITH THE PANDEMIC, I
JUST SHOWED YOU ON THE SLIDE,
BUT WE ALSO KNOW FROM A NUMBER
OF STUDIES THAT THERE IS A
SUBGROUP OF PATIENTS WHO ARE
DRINKING TO COPE WITH STRESS
DURING THE PANDEMIC.
AND HOPEFULLY THAT WILL DECLINE
SOMEWHAT AS WE EXIT FROM THE
PANDEMIC.
BUT OUR ARGUMENT IS THAT
PSYCHIATRIC COMORBIDITY,
CHILDHOOD TRAUMA, GENETICS,
EPIGENETICS ALL CONTRIBUTE TO
THE NEGATIVE EMOTIONAL STATE
THAT'S ASSOCIATED WITH THE
WITHDRAWAL NEGATIVE AFFECT
STAGE. NEXT SLIDE.
AND THIS ALL FITS WITH ONE OF
THE FOCUSES FOR NIAAA THAT WE'RE
LOOKING AT RIGHT NOW AND AGAIN
WILL BE A MAJOR PART OF OUR
STRATEGIC PLAN AND CHANGING THE
CONVERSATION AROUND RECOVERY.
MOST PEOPLE WHO NEED TREATMENT
RECEIVE NO TREATMENT OF ANY KIND
AND LITTLE IS KNOWN ABOUT WHAT
SUSTAINS LONGER TERM RECOVERY.
NIAAA IS EXPANDING FOCUS ON
LONGER TERM RECOVERY.
NIAAA HAS DEFINED RECOVERY FROM
ALCOHOL USE DISORDER BASED ON
QUALITATIVE FEEDBACK FROM KEY
RECOVERY STAKEHOLDERS.
SO WE VIEW RECOVERY AS BOTH A
PROCESS OF BEHAVIORAL CHANGE AND
AN OUTCOME TO INCORPORATE TIME
PERIODS FOR TWO KEY COMPONENTS.
REMISSION FROM DSM5AUD AND
CESSATION FROM HEAVY DRINKING.
OUR DEFINITION OF RECOVERY ALSO
EMPHASIZES THE IMPORTANCE OF BIO
PSYCH SOCIAL FUNCTIONING AND
QUALITY OF LIFE AND ENHANCE L
RECOVERY OUTCOMES.
AND SO NEXT SLIDE.
YOU KNOW, I JUST WANTED TO
QUICKLY TOUCH -- I'LL MAKE THIS
VERY QUICK, THAT A RECENT PAPER,
SHE TALKED ABOUT THIS IN HER
TALK YESTERDAY HAS SHOWN THAT
GREATER RELIEF NEGATIVE
EMOTIONALITY AT BASELINE
PREDICTED GREATER DRINKING
INTENSITY AND MORE FREQUENT
DRINKING AT ONE YEAR OUT IN
OUTCOMES FOLLOWING TREATMENT
USING -- THEY USED A LINEAR
REGRESSION ANALYSIS AND YOU CAN
SEE BETA HERE WHICH BASICALLY IS
SHOWING A VERY STRONG
RELATIONSHIP BETWEEN THIS
NEGATIVE EMOTIONALITY AND HEAVY
DRINKING DAYS.
THE NEXT SLIDE.
AND THE OPPOSITE WAS ALSO TRUE.
WHEN YOU PARSE THE GROUPS BY
DIFFERENT PROFILE AND YOU USED A
LOWER RELIEF NEGATIVE
EMOTIONALITY GROUP, THAT
PREDICTED HIGH FUNCTIONING
INFREQUENT DRINKING PROFILE.
AND SO THOSE INDIVIDUALS SHOWING
LESS PROBLEMS WITH NEGATIVE
EMOTIONALITY WERE MORE
REPRESENTED IN THE GROUP THAT
YOU WERE HOPING WOULD BE HIGH
FUNCTIONING AND NOT DRINKING OR
DRINKING MUCH LESS.
AND SO I THINK THIS VALIDATES
THE THREE DOMAIN FRAMEWORK BUT
NOW ALSO IN THE CONTEXT OF
RECOVERY AND ALLOWS US TO START
LOOKING AND BREAKING DOWN
INDIVIDUALS AS TO WHO IS GOING
TO RECOVER AND WHAT STEPS MIGHT
BE TAKEN, YOU MIGHT VERY QUICKLY
YOU MIGHT CONSIDER A DIFFERENT
MEDICATION FOR PEOPLE WHO ARE IN
THE RELIEF NEGATIVE EMOTIONALITY
PROFILE, YOU MIGHT CONSIDER A
DIFFERENT BEHAVIORAL TREATMENT.
NEXT SLIDE.
AND YOU KNOW, THIS IS AN OLDER
STUDY FROM DANIEL'S GROUP BY DR.
CHO AND BASICALLY, THIS SHOWS
THAT -- THAT IN INDIVIDUALS WITH
ALCOHOL DEPENDENCE, THEY SWITCH
FROM NEG -- POSITIVE
REENFORCEMENT BEING THE DRIVING
FORCE IN THEIR DRINKING TO
ACTUALLY NEGATIVE REENFORCEMENT
AND WE USED A DIFFERENT SCALES
OF PHYSICAL AND SOCIAL PLEASURE
SCALE FOR THE POSITIVE
REENFORCEMENT AND A RELAXATION
AND ATTENTION FOR NEGATIVE
REENFORCEMENT AND THEY USED THE
SEMISTRUCTURED ASSESSMENT FOR
THE GENETICS OF ALCOHOLISM AS A
MEASURE OF ALCOHOL DEPENDENCE,
BUT YOU CAN SEE A DRAMATIC
INCREASE IN NEGATIVE
REENFORCEMENT.
NEXT SLIDE.
AND SO I JUST WANT TO END BY
MENTIONING THAT A LOT OF THE
THINGS I'VE DISCUSSED ARE
AVAILABLE FOR HEALTHCARE
PROFESSIONALS IN TIN HEALTHCARE
CORE RESOURCES THAT WE LAUNCHED
LAST MAY A YEAR AGO.
THERE ARE 14 PRECISE ARTICLES.
AND INCLUDES INFORMATION ABOUT
CLINICAL IMPACTS OF ALCOHOL
INCLUDING CANCER, PAIN,
MEDICATION INTERACTIONS, AND
COOCCURRENCE WITH OTHER
SUBSTANCE USE DISORDERS AND
MENTAL HEALTH DISORDERS.
AND YOU CAN ACTUALLY GET CME
CREDIT FOR THIS.
IF YOU HAVEN'T CHECKED OUT THE
HPCR AS WE CALL IT FONDLY, YOU
KNOW WHAT A PCR IS, BUT IN THIS
CASE IT'S A PROFESSIONAL CORE
RESOURCE AND I THINK WE LIKE
THAT ACRONYM ON PURPOSE.
NEXT SLIDE.
SO THANKS A LOT.
SORRY I WENT OVER A LITTLE BIT,
NORA, BUT FEEL FREE TO DO THE
SAME.
>>THANKS VERY MUCH AND I
ACTUALLY -- I APPRECIATE IT.
AGAIN, IT'S A GREAT OPPORTUNITY
AND I'M GOING TO DO -- I'M NOT
GOING TO SPEAK FROM OVER THERE
BECAUSE GEORGE INSPIRED ME TO DO
IT HERE SO I APOLOGIZE, GUYS.
WHAT I'M GOING TO DO IS SHARE MY
SCREEN SO I'M GOING TO -- AND I
HOPE THERE ARE NO PROBLEMS WITH
THAT.
I JUST WILL NEED TO LET YOU --
LET ME KNOW IF YOU CAN SEE IT.
HOLD ON ONE SECOND SINCE I'M
HERE I CAN SEE IF I CAN SEE.
OKAY.
YES.
PERFECT.
AND I MEAN, WE HAVE COUNCIL
YESTERDAY SO I GAVE A
PRESENTATION IN TERMS OF SOME OF
OUR TOP PRIORITIES AND OUR
THINKING IN TERMS SO WHAT I
WOULD WANT TO PRESENT TO CRAN
THAT ARE VERY, VERY RELEVANT AND
I DO WANT TO HIGHLIGHT WHAT
GEORGE SAID.
I MEAN, THE REALITY THAT WE'RE
LIVING IS THAT MORE AND MORE
PEOPLE ARE MIXING DRUGS AND ONE
OF THE DRUGS THAT THEY'RE MORE
FREQUENTLY MIXING IS ALCOHOL AND
ALSO AS WE LOOK AT THE
TRAJECTORIES OF DRUG USE AS
PEOPLE GO FROM ADOLESCENCE INTO
ADULTHOOD, ALCOHOL IS ONE OF THE
MAIN DRUGS THAT INITIATE THAT
CONSUMPTION.
SO UNDERSTANDING HOW DRUGS
INTERACT WITH ONE ANOTHER AND
HOW THOSE DYNAMIC INFLUENCE
BASICALLY DEVELOPMENT THE USE OF
OTHER ABUSE DISORDERS AND
RESPONSES TO TREATMENT ARE
CRUCIAL IN TERMS OF OUR
PREVENTION AND TREATMENT
INTERVENTIONS.
BEFORE I JUMP INTO THE SPECIFICS
I DO WANT TO BASICALLY JUST GIVE
YOU AN UPDATE RAPIDLY OF CHANGES
IN THE OFFICE BECAUSE THESE ARE
VERY RELEVANT FOR ALL SUBSTANCE
DISORDERS INCLUDING ALCOHOL USE
DISORDER OF COURSE AND THAT IS
WELCOMING DR. CRUMP WHO IS
BASICALLY REPLACING DR. AVILA
AND SHE IS THE DIRECTOR OF
OFFICE OF DIVERSITY AND
DISPARITIES AND SHE'S ALSO THE
DEPUTY DIRECTOR FOR THE OFFICE
OF TRANSLATIONAL -- OFFICE OF
RESEARCH AND TRAINING DIVERSITY
AND DISPARITIES.
THE OTHER ONE THAT I WANT TO
OFFICIAL ANNOUNCE IS THAT DR.
LEGGIO WHO ALSO HAS JOINED
APPOINTMENTS WITH THE PROGRAM AT
NIAAA AND IS NOW OFFICIALLY OUR
CLINICAL DIRECTOR AT THE NIDA
INTRAMURAL PROGRAM AND I WANT TO
WELCOME THEM.
SO LET ME NOW JUMP SPECIFICALLY
INTO THE DATA AND WITH GETTING
BASE CHI ALL TOGETHER AS PART OF
THE CRAN.
WITH THE COVID PANDEMIC THERE
WAS SOMETHING VERY INTERESTING
HAPPENING AMONG THE USE OF DRUGS
IN TEENAGERS AND THIS WAS VERY
DIFFERENT FROM THE VERY
SIGNIFICANT RISE THAT WE SAW AND
THAT GEORGE WAS JUST SPEAKING OF
JUST NOW FOR ALCOHOL, THE SAME
HAPPENED FOR OTHER DRUGS IN OUR
COUNTRY FOR ADULTS INCLUDING
MARIJUANA, VERY IMPORTANTLY
MARIJUANA.
BUT THAT DID NOT HAPPEN IN
TEENAGERS.
IN FACT WE SAW A VERY
SIGNIFICANT REDUCTION IN DRUG
CONSUMPTION FOR LEGAL AND
ILLEGAL DRUGS FOR TEENAGERS AS
ASSESSED BY MONITORING THE
FUTURE AND ALSO CORROBORATED BY
OTHER SURVEYS.
AS SCHOOLS CLOSED DOWN THERE
WERE MANY LESS OPPORTUNITIES FOR
TEENAGERS TO INTERACT WITH
OTHERS, TO HAVE THE PEER
PRESSURE TO CONSUME DRUGS, BUT
BASICALLY EVENTS LIKE SPORTS
EVENTS WHERE THEY ACTUALLY DRINK
ALCOHOL OR MAY SMOKE MARIJUANA
WERE NO LONGER POSSIBLE.
SO THIS ACTUALLY PROTECTED KIDS,
THE CLOSING OF THE SCHOOLS AND
OVERSIGHT OF THE PARENTS THAT
WERE THERE.
AND SO WE WERE VERY CONCERNED
THAT WHEN THE COVID PANDEMIC
ENDED AND IMPORTANTLY WHEN THE
SCHOOL STARTS TO OPEN UP WE WILL
SEE AN UP TICK IN THE PREVALENCE
RATES OF DRUG USE IN TEENAGERS.
SO LAST YEAR IN 2022, WHEN MOST
OF THE SCHOOLS BASICALLY ALL OF
THE SCHOOLS HAD OPENED WE WERE
VERY SURPRISED, VERY HAPPILY
SURPRISED TO SEE THAT WE DID NOT
SEE THE UPTICK WHERE VALUES DID
NOT GO FURTHER DOWN, BUT THEY
DID NOT WENT UP EXCEPT THERE
WERE A FEW EXCEPTIONS AND VERY
NOTABLY AND THAT'S WHY I'M
PUTTING IT HERE.
IT WAS ALCOHOL USE AMONG 12th
GRADERS WHICH ACTUALLY JUMPED TO
THE PREPANDEMIC LEVELS AND I
THINK IT HELPS US TO UNDERSTAND
OVERALL WHAT IS CHANGING IN THE
PATTERN OF DRUG CONSUMPTION OF
TEENAGERS, BECAUSE CERTAINLY THE
COVID ACCENTUATED A DECLINE BUT
THAT DECLINE WE HAVE BEEN
OBSERVING SINCE I WOULD SAY
2003, 2005.
THE DECLINING CONSUMPTION BY
TEENAGERS, IT'S STILL VERY HIGH
AND WE HAVE A LOT OF WORK TO DO
IN PREVENTION AMONG TEENAGERS
BUT WE HAVE TO RECOGNIZE THAT
THERE ARE CHANGES IN THE
CONSUMPTION OF DRUGS IN
ADOLESCENTS IN OUR COUNTRY.
THIS ACTUALLY JUST ILLUSTRATES
WHAT I'M SPEAKING ABOUT.
THIS IS PERCENT OF REPORTING ANY
ILLICIT DRUG USING BY YEAR, BY
GRADE.
MOST OF ILLICIT DRUG REFLECTS
MARIJUANA AND YOU CAN SEE
BASICALLY HOW BETWEEN 19 AND 202
WHEN THE CLOSED AND YOU CAN SEE
THAT 2020 DECREASE, VERY
DRAMATIC DECREASE IN CONSUMPTION
OF DRUGS AND THEN YOU CAN SEE
THE STABILIZATION AND WE NEED TO
MONITOR WHAT EXTENT THAT REMAINS
OR WHETHER IT'S MODIFIED AND
WHAT CHARACTERISTICS IS AT
STAKES.
I MENTIONED IT'S GOING DOWN BUT
WE STILL HAVE PRETTY HIGH
PREVALENCE RATES AMONG TEENAGERS
IN OUR COUNTRIES FOR CONSUMPTION
OF SUBSTANCES INCLUDING ALCOHOL
WHICH YOU SEE OVER THERE IS THE
NUMBER ONE DRUG CONSUMED.
THESE METRICS REPRESENT THE
PREVALENCE OF PAST YEAR DRUG USE
AMONGST 12th GRADERS, AS
TEENAGERS AGE OUT THEY ACTUALLY
CONSUME MORE AND MORE DRUGS AND
THEN IN THAT TRANSITION THAT
ACTUALLY FURTHER INCREASES.
SO WHAT I AM PRESENTING THEN TO
GET A SENSE ABOUT PREVALENCE
RATES WHAT WE'RE SPEAKING, 50%
ALCOHOL, MOSTLY THAT IS
NICOTINE, ONE THIRD OF THEM.
MARIJUANA, MOST SPEAKING IS THE
MAIN DRUG OTHER THAN ALCOHOL AND
THEN WE HAVE VAPING OF MARIJUANA
WHERE 20% OF 12th GRADERS REPORT
THE VAPING.
IN RED THOUGH I HIGHLIGHT THE
PRESCRIPTION -- ILLICIT
PRESCRIPTION -- USE OF
PRESCRIPTION DRUGS BY TEENAGERS
BECAUSE THIS IS SOMETHING THAT
TEENAGERS FAVOR.
WE'RE SEEING THE LOWEST RATES OF
COCAINE USE, OF HEROIN USE,
BASICALLY WE HAVEN'T ACTUALLY --
WE ARE WORRY ABOUT THE USE OF
FENTANYL PER SE BECAUSE THESE
ARE PATTERNS THAT THEY FAVOR.
THEY FAVOR DRUGS THAT ARE
ILLEGAL AND THEY FAVOR ACTUALLY
PRESCRIPTION DRUGS AND THESE ARE
THE PRESCRIPTION DRUGS OF WHICH
MEDICATIONS BUT ADDERALL HAS THE
HIGHEST RATES.
THEY ALSO FAVOR OPIOID
MEDICATIONS AND THESE
MEDICATIONS, THESE PRESCRIPTION
MEDICATIONS OVERALL CAN HAVE --
MAYBE USED OCCASIONALLY BUT THE
PROBLEM IS NOW DURING THE COVID
PANDEMIC SOMETHING PRETTY
DRAMATIC CHANGED WHICH WAS FIRST
OF ALL FENTANYL COVERED THE
WHOLE COUNTRY BUT ONE, DURING
THE COVID PANDEMIC IN PARTICULAR
ONE OF THE WAYS THAT FENTANYL IS
BEING BROUGHT INTO OUR COUNTRY
IS THESE GUYS IN ILLICITLY
MANUFACTURED MILLS THAT ARE
ALMOST IDENTICALLY LOOKING PILLS
FOR EXAMPLE AS ADERALL OR
OTHERSnd IF YOU WANT TO BUY THEM
ON THE WEB THEY'RE MUCH LESS
EXPENSIVE THAN THE REAL ONES SO
YOU CAN SEE WHY PEOPLE ARE NOW
GETTING EXPOSED TO OVERDOSES BY
BUYING PRESCRIPTION PILLS
WITHOUT KNOWING IF IT'S
CONTAMINATED AND REPRESENT A WAY
OF FENTANYL ENTERING THE
COUNTRY.
TEENAGERS THEREFORE ARE 90%
OF -- DEATHS FROM FENTANYL IN
TEENAGERS FROM RISED AND THIS IS
LIKELY TO REPRESENT THIS AND YOU
SEE THAT WITH THE COVID PANDEMIC
HOW ALL OF THESE NUMBERS ARE
GOING WAY, WAY UP AND THAT'S THE
BLUE LINE.
BUT I DID WANT TO BRING FORWARD
THAT THE ORANGE LINE, BECAUSE
EVEN THOUGH THE OVERDOSE DEATHS
ON TEENAGERS FOR NONFENTANYL
RELATED CASES ARE LOW, AND THE
BASICALLY MORE OR LESS PLATEAU,
I MEAN, IN TRYING TO UNDERSTAND
WHAT IS DRIVING THIS AND I THINK
PERHAPS ONE OF THE MAIN CULPRITS
MAY BE ALCOHOL OVERDOSES AND
GEORGE AND I HAVE SPOKEN ABOUT
IT BECAUSE THIS IS SOMETHING
THAT PEOPLE DON'T NECESSARILY
RECOGNIZE THAT YOU CAN DIE FROM
AN OVERDOSE FOR ALCOHOL AND THIS
IN TEENAGERS MAY RESULT
PRACTICES THAT THEY FEEL ARE
SAFE AND THEY DON'T WANT THEIR
PARENTS TO KNOW, SO SOMEONE THAT
IS UNCONSCIOUS THEY DON'T BRING
THEM TO THE EMERGENCY DEPARTMENT
SO UNDERSTANDING THAT ALCOHOL IS
A RISK FACTOR FOR OVERDOSE IS
IMPORTANT AND WHEN YOU ADD THE
NOTION THAT TEENAGERS COMBINE
LIKE ADULTS COMBINE DRUGS YOU
CAN SEE WHY THESE CAN BE
EXACERBATED.
SO AS WE LOOK AT DATA LIKE THIS,
TO ME, IT HIGHLIGHTS HOW SOME OF
THAT KEY RESEARCH FOR ALL OF US
IS IMPLEMENTATION AND GEORGE WAS
SPEAKING ABOUT IT.
THAT'S ACTUALLY INCLUDES OF
COURSE ALCOHOL BUT IT'S THE
NOTION THAT EARLY IDENTIFICATION
AND THE IMPORTANCE OF ACTUALLY
ADVANTAGE OF SYSTEMS TO DO THAT
SCREENING IS CRUCIAL AND GEORGE
AND I IN PARTNERSHIP WROTE A
COMMENTARY WHERE WE WERE
PROPOSING THE NOTION OF
DEVELOPING A TERM THAT WE
TEMPORARY DESCRIBE AS
PREADDICTION, BUT THE MANNER,
WHAT IS IMPORTANT IS RECOGNIZING
A MEANS TO HELP FOR PHYSICIANS
OR OTHER CLINICIANS HELP
IDENTIFY SOMEONE FOR THESE
DISORDERS AND THEY CAN HAVE
CODES THAT CAN APPLY FOR
REIMBURSEMENT AND THAT IS THE
GOAL.
I THINK THE OTHER ASPECT IS NOT
JUST ABOUT SCREENING BUT WHAT
ARE THE INTERVENTIONS THAT ARE
ACTUALLY GOING TO LEAD TO
IMPROVED OUTCOMES AND
HIGHLIGHTING THE SUBSTANCE USE
DISORDER THE IMPORTANCE OF
DEVELOPMENT AND RESEARCH FOR THE
TREATMENT OF ADOLESCENTS, WITH
MILD, MODERATE OR SEVERE
SUBSTANCE USE DISORDER BECAUSE
THE DATA THAT WE HAVE IS VERY
LIMITED AND JUST LOOK AT A MED
SEARCH IN TERMS OF CLINICAL
TRIALS TO DOCUMENT THE USE OF
MEDICATIONS FOR ADOLESCENTS AND
YOU WILL SEE HOW VERY FEW THEY
ARE.
I ALSO WANT BRING THE SLIDE
WHICH I PRESENTED IN OUR
FEBRUARY COUNCIL TO MAKE
EVERYONE AWARE OF IT.
I MEAN, WE ALL KNOW THAT
MARIJUANA IS BEING LEGALIZED ALL
OVER THE COUNTRY.
WE SEE 21 STATES AND I MENTIONED
YESTERDAY IN COUNCIL, I -- I WAS
WORKING IN AUSTIN.
I GO INTO A STORE THAT SELLS
DRUG PARAPHERNALIA AND LO AND
BEHOLD, THEY ARE SELLING 9 AND
10 -- NOT 10.
8 AND 10THC PRODUCTS WITH VERY
HIGH CONTENT AND DOSES THAT
ACTUALLY ARE LIKELY TO PRODUCE
VERY SEVERE INTOXICATION.
AND THE CONSEQUENCES IS WHAT I
PRESENTED IN FEBRUARY.
THIS IS DATA SHOWING THAT YES,
WE KNOW THAT LEGALIZATION HAS
INCREASED THE MARIJUANA USE
AMONG ADULTS ALL OVER THE
COUNTRY AND THE NUMBERS ARE
GOING UP AND IT'S ACTUALLY -- IT
HAS TRIPLED BASED ON THIS ONE.
BUT IF YOU LOOK AT BASICALLY
NORMAL USERS IT HAS QUADRUPLED.
SO REGULAR USE IS GOING UP.
AND LOOK THEN AT THE RED LINES.
DAILY USERS INCREASED 14 FOLD
FROM 1992 TO 2020.
AND ALSO IN THE YELLOW LINE IS
THE AMOUNT OF THC THAT PEOPLE
ARE CONSUMING ON A REGULAR BASIS
IS GOING UP.
SO YOU THINK INCREASES, MASSIVE
INCREASES IN REGULAR USE OF
MARIJUANA ASSOCIATED WITH VERY
HIGH DOSES OF THC AND THAT LEADS
TO NEGATIVE OUTCOMES AT MULTIPLE
LEVELS SO WE NEED TO INVESTIGATE
THESE AND I ACTUALLY -- I
ALSO -- THIS ONE I SHOWED
YESTERDAY BECAUSE I WANT PEOPLE
TO BE AWARE OF THE DYNAMICS OF
POLY SUBSTANCE USE. THIS IS THE
MORTALITY ASSOCIATED IN PEOPLE
THAT BASICALLY WHAT THEY SEE
THAT THERE WAS DETECTION OF THE
MARIJUANA.
THAT DOESN'T MEAN THAT THE
MARIJUANA CREATED THE OVERDOSE
THERE BUT IT MEANS THAT THE
PERSON THAT WAS DECEASED HAD
MARIJUANA IN THEIR SYSTEM.
THE LIGHT GREEN ACTUALLY IS
MARIJUANA, BASICALLY IN
COMBINATION WITH OPIOIDS OR
STIMULANTS WHICH HIGHLIGHTS THE
LIKELIHOOD THAT THESE PEOPLE ARE
USING MULTIPLE DRUGS AND THIS IS
THE DYNAMIC THAT WE NEED TO
INVESTIGATE.
JUST LIKE WE NEED TO INVESTIGATE
THE DYNAMIC WITH ALCOHOL.
BUT IF YOU LOOK AT THE DARK
GREEN, THOSE ARE INDIVIDUALS
THAT BASICALLY ARE PREDOMINANTLY
PLANT BASED AND MORE AND MORE
WE'RE SEEING PEOPLE CONSUMING
VERY HIGH DOSES OF THC IN
AMERICA.
THAT IS TOTALLY UNREGULATED FOR
THE MOST PART AND PUTTING PEOPLE
AT RISK.
AND WE NEED TO KEEP AN EYE ON
IT.
THAT NOTION THAT MARIJUANA IS
SAFE IS NOT REALLY SUPPORTED BY
THE EVIDENCE AND I THINK THAT
THIS IS SOME OF THE DATA THAT
SHOWS THIS.
SO WHAT ARE OUR PRIORITIES?
WE NEED TO PRIORITIZE OBVIOUSLY
UNDERSTANDING ABOUT HOW
BASICALLY THE PHARMACOLOGY OF
THESE COMPOUNDS AND AGAIN, IT'S
NOW WE'RE SEEING MORE 8 AND
10THC AND WHEN THEY COMBINE WITH
OTHER DRUGS LIKE ALCOHOL FOR
EXAMPLE THAT AFFECTS THEIR
OUTCOMES.
WE NEED TO UNDERSTAND FACTORS
THAT LEAD TO RISK.
THERE'S BEEN A LOT OF WORK IN
TERMS OF GENETIC VULNERABILITY
AND THE VULNERABILITY MAY
REFLECT VERY POWERFUL A GENETIC
VULNERABILITY FOR ADDICTION IN
GENERAL AND FEW GENES THEN
REFLECT VULNERABILITY FOR
SPECIFIC TYPES OF DRUGS.
THIS IS AGAIN, IMPORTANT BECAUSE
THESE GENES ALSO INFLUENCE OTHER
OUTCOMES.
THEY ARE NOT JUST CAUSING FOR
INCREASED RUSK FOR MARIJUANA
RISK BUT INCREASED RISK FOR
SCHIZOPHRENIA BUT ALSO THEY MAY
BE FACTORS THAT NONETHELESS
DESPITE THESE GENETIC INCREASES
IN RISKS THAT ARE COMMON,
THEY'RE FACTORS THAT MAINLY FROM
A PHARMACOLOGICAL RESULT FROM
MARIJUANA ITSELF.
WE HAVE A NEED TO UNDERSTAND
ALSO NEGATIVE CONSEQUENCES IF
THERE ARE OF CHRONIC CONSUMPTION
OF MARIJUANA WHICH WE KNOW THERE
ARE.
BUT WE NEED TO UNDERSTAND THEM
BETTER IN WAYS THAT CAN BE
TRANSLATED INTO INTERVENTIONS
AND IMPORTANTLY, WE DO NOT HAVE
ANY TREATMENT MITIGATIONS
APPROVED FOR CANNABIS USE
DISORDER SO THIS IS ANOTHER AREA
OF PRIORITY.
SO NOW I JUMP INTO THE OPIOID
CRISIS BECAUSE THIS IS WHAT HAS
BEEN TAKING AN ENORMOUS AMOUNT
OF OUR EFFORT AT THE INSTITUTE
WHERE WE HAVE AN OPPORTUNITY TO
BRING KNOWLEDGE THAT CAN HELP US
ADDRESS THE ISSUES.
THIS IS DATA SHOWING THE
DIFFERENT DRUGS THAT ARE
COUNTING FOR THE OVERALL
OVERDOSE MORTALITY IN OUR
COUNTRY AND I'M BASICALLY
PUTTING AND ACTUALLY IN THE
BROWN OR GOLDEN BROWN THOSE THAT
ARE RELATED TO FENTANYL AND YOU
CAN SEE THE SYNTHETIC OPIOIDS,
73,000 OUT OF THE 81,000 OPIOID
DEPTHS ARE RELATED TO FENTANYL.
SO WHAT IS THIS TELLING US?
IT'S TELLING US CERTAINLY THAT
FENTANYL IS A MAIN, MAIN
CULPRIT.
BUT IT'S ALSO TELLING US THAT
MORE AND MORE AND MORE OF THE
OVERDOSE DEATHS RELATED TO -- IN
GENERAL ARE ALSO DRIVEN BY
SYNTHETICS SO THE OTHER CULPRITS
IS THE METHAMPHETAMINE.
THIS IS A SYNTHETIC DRUG AND
THIS IS SOMETHING WE'LL BE
SEEING INTO THE FUTURE.
INNOVATION FOR DEVELOPMENT OF
INCREASINGLY MORE POWERFUL DRUGS
AND THIS IS A CHALLENGE THAT WE
FACE.
AND SO THE CONCEPT WE ALL KNOW
WHY -- WHY FENTANYL IS SUCH AN
IMPORTANT CONTRIBUTOR, BUT
NUMBER ONE, EXTREMELY POTENT SO
IT HAS A 50% HIGHER POTENCY THAN
HEROIN ITSELF WHICH MEANS IT'S A
MUCH MORE DRUG REQUIRED,
BASICALLY A HIGHER RISK FOR
ADDICTION BUT ALSO HIGHER RISK
FOR RESPIRATORY DEPRESSION.
OTHER ELEMENT ABOUT IT, IT
ENTERS INTO THE BRAIN VERY
RAPIDLY, MUCH FASTER THAN THE
HEROIN.
WHICH MEANS YOU NEED TO DO THE
OVERDOSE REVERSAL ADMINISTRATION
OF DRUGS IN A MUCH SHORT ERWIN
DOE AND THAT HAS LED TO MAJOR
CHALLENGES IN BEING ABLE TO SAVE
LIVES.
AND THE OTHER THING IS FENTANYL,
DEPRESS IFR EFFECTS ARE LONGER
EFFECTS. WHICH MEANS THAT MORE
AND MORE REPORTS ARE DOCUMENTING
THE NEED OF MULTIPLE DOSES OF
NALOXONE.
THE ASPECT TOO THAT REQUIRES
ATTENTION ON ALL OF THIS IS THAT
FENTANYL IS VERY, VERY POTENT BY
ITSELF BUT THAT WE ARE FACING
WITH TERMS OF OVERDOSE REVERSALS
ARE EXACERBATED BY THE FACT THAT
FENTANYL IS BEING CONTAMINATED
AND CONSUMED WITH OTHER DRUGS,
WHETHER IT IS COCAINE, WHETHER
IT'S ALCOHOL, WHETHER IT'S OTHER
DRUGS, NOW WE'RE SEEING IT AND
THIS IS NOT THE DRUG THAT
THEY'RE SEEKING SPECIFICALLY BUT
IT'S BY THE DEALERS AND I
APPRECIATE THE UPDATE ON THAT
YESTERDAY SO I'M NOT GOING TO
BELABOR ON THAT, BUT WHAT IT
DOES TELL US IS THAT WE NEED TO
UNDERSTAND BETTER HOW TO
PROPERLY PREVENT, TREAT
INDIVIDUALS WITH FENTANYL USE
DISORDER AND HOW TO TREAT THOSE
OVERDOSES.
THE FENTANYL EPIDEMIC HAS
DRAMATICALLY CHANGED THE
DYNAMICS OF WHO GETS INFLUENCED,
FENTANYL HAS MADE MANY
DEMOGRAPHICS NOW VULNERABLE FOR
OVERDOSES THAT WERE NOT IN THE
PAST.
SO I'M PRESENTING YOU THE
DIFFERENCES BASICALLY IN PINK OF
OVERDOES DEATHS DURING THE
PANDEMIC TO SHOW YOU THEY WENT
UP OVER THE THREE YEARS OF THE
COVID PANDEMIC BUT IT WAS
ACTUALLY THE INCREASES WERE MUCH
MORE DRAMATIC AMONG MEN THAT
WERE AFRICAN AMERICAN OR OF
AMERICAN INDIAN OR ALASKA
NATIVES.
2.4 TO 2.8 HIGHER MORTALITY IN
MEN THAN WOMEN.
MORTALITY IS HIGHEST IN THOSE
THAT ARE 24 TO 34.
THAT'S NOT THE DISTINCTION YOU
HAVE THERE BUT OVERALL YOU SEE
THESE MEN IN THE MIDDLE AGE,
YOUNG MIDDLE AGE THAT ARE AT
HIGHEST RISK, BUT I DO ALSO WANT
TO POINT SOMETHING I FIND VERY
SHOCKING WHICH IS LOOK AT WOMEN
AGE 35 TO 54 IN TERMS OF THE
OVERDOSE MORTALITY.
THEY HAVE RATESES OF OVERDOSE
MORTALITY THAT ARE HIGHER THAN
THOSE OF MEN THAT -- FROM OTHER
RACIAL AND ETHNIC GROUPS
HIGHLIGHTING THE IMPORTANCE THAT
WE NEED TO DO IN FENTANYL, IT'S
BASICALLY CONTAMINATED ALL THE
ILLICIT DRUGS THAT WE KNOW OF,
NOT NECESSARILY MARIJUANA,
MAKING INDIVIDUALS THAT DO NOT
USE HEROIN IN THE PAST ARE NOW
VERY VULNERABLE FOR OVERDOSES.
TARGET INTERVENTIONS TO BLACK
AMERICANS, TARGET INTERVENTIONS
TO AMERICAN INDIANS AND ALASKA
NATIVES THAT ARE CULTURAL
SENSITIVE.
I WANT TO END MY PRESENTATION IN
SAYING ALL OF THIS HAS BEEN A
MAJOR PRIORITY FOR US AND IT IS
CLEAR TO CONTINUE BE ONE OF THE
USES FOR THE ALCOHOL USE
DISORDER AND IN GENERAL FOR ANY
SUBSTANCE USE DISORDER.
AS WE THINK ABOUT THE ALCOHOL
ABUSE DISORDER IT IS FENTANYL
THAT HAS MORE SEVERE TOLERANCE.
AND HOW CAN WE OPTIMALLY UTILIZE
THEM TO LEAD TO BETTER OUTCOMES.
GEORGE WAS NOTING AND I THINK
THIS IS, AGAIN, AN EXTREMELY
IMPORTANT MESSAGE THAT HAS
CLINICAL IMPLICATIONS WHICH IS
THE NEGATIVE EMOTIONAL COMPONENT
IS ONE OF THE MOST CONSEQUENTIAL
IN DRIVING BASICALLY STOPPING --
NOT PARTICIPATING IN TREATMENT
BUT ALSO ONCE THEY ARE
PARTICIPATING IN TREATMENT TO
ACTUALLY NOT STAYING IN
TREATMENT, TO ADDRESSING THE
OPPORTUNITY OF -- THAT NEGATIVE
EMOTIONAL STATE IS KEY IN
ASSOCIATION WITH MANY OF THESE
TREATMENTS SO THIS IS SOMETHING
THAT WE ARE BASICALLY
ENCOURAGING RESEARCHERS.
LET'S PASS MULTIPLE THERAPIES.
WE ARE NOT BOUND TO GIVE ONE
MEDICATION OR ONE INTERVENTION.
AND THE SAME THING WITH RESPECT
TO TECHNOLOGIES WHICH ACTUALLY
ARE QUITE EXTRAORDINARY
POTENTIAL BECAUSE AS WE
UNDERSTAND BETTER, GEORGE WAS
SPEAKING ABOUT THE CYCLE AND THE
NETWORKS IN THE BRAIN THAT ARE
ENGAGED IN THESE DIFFERENT
PROCESSES, AS WE UNDERSTAND
THOSE NETWORKS BETTER, WE CAN
TARGET THEM WITH NEURAL
MODULATION AND IMPORTANTLY HE
WAS HINTING YOU CAN CHARACTERIZE
THE PATTERN OF CLINICAL
PRESENTATION OF AN INDIVIDUAL
WITH A SUBSTANCE USE DISORDER
THEN DETERMINE WHICH ARE THE
NETWORKS WHICH THEY HAVE
STRAINED AND WHICH ARE THE
WEAKER ONES, WHERE YOU CAN
TARGET PERSONALIZED
INTERVENTIONS AND I THINK THIS
SEASON AREA OF EXTRAORDINARY
IMPORTANCE AND AT THE SAME TIME
WE NEED TO FURTHER DEVELOP MORE
INTERVENTIONS IN THE CASE OF
OVERDOSES THAT WE'LL BE ABLE TO
REVERSE, NOT JUST OVERDOSES OF
PURE OPIOIDS BECAUSE THEY ARE
INCREASINGLY LESS FREQUENT FOR
OVERDOSES THAT ARE DRUG
COMBINATIONS INCLUDING THOSE
WITH ALCOHOL.
AND WITH THAT I WANT TO THANK
YOU FOR YOUR ATTENTION.
>>THANK YOU, NORA.
SO I THINK WE'LL JUST NOT PAUSE
FOR QUESTIONS FOR EITHER ONE OF
US AND JUST MOVE ON TO WILLIAM
KLEIN WHO'S GOING TO TALK ABOUT
CRAN RELATED NCI ACTIVITIES AND
PRIORITIES.
WE DO HAVE A DISCUSSION LATER
TODAY AND IF WE -- AND SO SAVE
UP YOUR QUESTIONS AND THINK
ABOUT THEM FOR BOTH OF US AND
WE'LL TRY AND CARVE OUT THAT
TIME IN THE SCHEDULE LATER.
ALL RIGHT.
SO HOW ARE WE PROCEEDING, JOHN?
IS DR. KLEIN'S TALK READY TO
ROLL?
>>I CAN SHARE THEM OR DR. KLEIN
CAN.
WHATEVER THE PREFERENCE IS.
>>OH, PLEASE GO AHEAD.
YEAH.
>>ALL RIGHT.
LET ME FIND THEM.
>>I'VE GOT THEM TOO IF THAT'S
EASIER.
>>SO DR. KLEIN IS THE ASSOCIATE
DIRECTOR OF NCI'S BEHAVE I DON'T
RECALL RESEARCH PROGRAM.
I THINK WE'VE ALL MET HIM BEFORE
AND I'M LOOKING FORWARD TO HIS
TALK.
>>YOU GOT IT.
>>SAY NEXT PLEASE AND I'LL
CLICK IT FOR YOU.
>>IS THERE ANY WAY YOU CAN MAKE
THE MAIN SCREEN HERE DISAPPEAR?
THE PICTURES ON THE RIGHT-HAND
SIDE?
>>I'M SURE IT CAN BE DONE BUT
NOT BY ME.
>>PHILLIP IS GOING TO LOOK AT
IT HERE.
>>THANKS.
>>NORA'S SLIDES BLESSEDLY WERE
ALL ON THE LEFT SIDE OF THE
SCREEN SO WE WERE ABLE TO SEE
MOST OF THEM VERY CLEARLY, BUT I
THINK IT LOOKS LIKE -- THE YOU
GO BY BILL, DR. KLEIN?
>>YES, BILL IS FINE.
>>SO LOOKS LIKE YOURS ARE ON
THE RIGHT SIDE OF THE SCREEN SO
WE JUST CLEARED THEM SO WE CAN
SEE THEM NOW.
IT'S ALL YOURS.
>>GREAT.
THANK YOU, GEORGE.
AND THANKS, FOR TWO TERRIFIC
PRESENTATIONS.
I APOLOGIZE I'M NOT THERE IN
PERSON.
I'M IN PITTSBURGH JUST HAVING
GIVEN A TALK AT THE CANCER
CENTER AT THE UNIVERSITY OF
PITTSBURGH AND SO I'M HOPING
NEXT TIME I'LL BE THERE IN
PERSON BUT FOR NOW WE'RE GOING
TO DO VIRTUAL.
IF YOU CAN GO TO THE NEXT SLIDE.
I WOULD LIKE TO TALK ABOUT WHAT
WE'VE BEEN DOING AT NCI RELATED
TO CRAN PRIORITIES BUT I WANTED
TO SAY A FEW THINGS UPFRONT.
FIRST THE LAST TIME YOU HEARD
FROM ME A YEAR AGO WE DIDN'T
HAVE A NEW NCI DIRECTOR. WE HAD
AN APPOINTEE WHO HADN'T BEEN IN
PLACE YET SO MONICA BERTAGNOLLI
IS OUR NEW DIRECTOR. AND SHE'S
BEEN TERRIFIC SO FAR AND IS WELL
AWARE OF THE INTEREST WE HAVE IN
TOBACCO CESSATION AND TOBACCO
CONTROL MORE GENERALLY AND HAS
BEEN ENGAGED WITH THIS TOPIC SO
REALLY IMPORTANT.
YOU CAN HIT THE NEXT SLIDE.
IT'S ACTUALLY AN ANIMATION.
YOU PROBABLY HAVE SEEN THESE
NEWS ARTICLES THAT PRESIDENT
BIDEN IS GOING TO NOMINATE
MONICA TO BE THE NEW DIRECTOR OF
THE NATIONAL INSTITUTES OF
HEA
HEALTH.
WE HAVE BEEN ASKED TO REASSURE
THE EXTRAMURAL COMMUNITY THAT
SHE WILL CONTINUE TO SERVE THE
ROLE OF NCI DIRECTOR AND I CAN
TELL YOU SHE'S VERY ACTIVE.
FOR ANY OF YOU THAT ATTEND
MEETINGS LIKE THE AMERICAN
ASSOCIATION OF CANCER RESEARCH
OR ASCO, VARIOUS OTHERS, SHE
RUNS AROUND AND ENGAGES WITH THE
COMMUNITY IN MANY WAYS, GIVERS
LOTS OF TALKS ON HER PRIORITIES.
SHE'S BEEN VERY ACTIVE AND
REALLY A TERRIFIC DIRECTOR SO
FAR AND WE'LL SEE WHAT HAPPENS
WITH THE NIH DIRECTOR
APPOINTMENT.
NEXT SLIDE, PLEASE.
WE OF COURSE ARE CONSTANTLY
ENGAGED IN CANCER MOON SHOT
ACTIVITIES.
HOPEFULLY YOU'RE FAMILIAR WITH
THE MOON SHOT INITIATIVES THAT
WAS INITIATED IN THE OBAMA
ADMINISTRATION AND IS CURRENTLY
CONTINUING IN HIS TERM AS
PRESIDENT.
AND IT INCLUDES TOBACCO CONTROL
AND ALSO ALCOHOL, AND SO WE ARE
VERY MUCH ENGAGED IN CANCER MOON
SHOT ACTIVITIES WITHIN OUR
DIVISION AND ALSO WITHIN THE
BEH
BEHAVIORAL RESEARCH DIVISION
THAT I LEAD.
SHE ASKED US TO ENGAGE IN A
STRATEGIC PLANNING ACTIVITY OVER
THE LAST YEAR AND A HALF TO KEY
IN ON SOME AREAS THAT EITHER
NEED RENEWED ATTENTION OR NEW
ATTENTION AND YOU CAN SEE WHAT
THOSE ARE HERE AND I DO WANT TO
ADD A CAVEAT BEFORE SAYING
ANYTHING MORE, WHICH IS THAT
MOST OF OUR PORTFOLIO INCLUDES
INVESTIGATOR INITIATED GRANTS
AND WE'RE OPEN TO A LOT OF
DIFFERENT TOPICS SO THAT'S NOT
TO SAY THESE ARE THE ONLY THINGS
WE WANT TO FUND BUT THESE ARE
SOME TOPICS THAT ARE CAPTURING
OUR IMAGINATION MORE RECENTLY
AND I'M SURE NONE OF THESE ARE
SURPRISING.
HEALTH EQUITY A MAJOR PRIORITY
FOR US AND A PRIORITY THROUGHOUT
NIH.
DATA SHARING AND ALL THE ISSUES
THAT GO WITH THAT ARE A BIG
TOPIC OF CONVERSATION WITHIN OUR
DIVISION.
MOD FINAL RISK FACTORS INCLUDE
AGO LOT THAT WE TALK ABOUT HERE
WITHIN CRAN AND ALSO TRYING TO
UNDERSTAND COUSE AND HOW
BEHAVIORS INTERACT.
AND THAT'S SOMETHING THAT'S
GOTTEN LESS ATTENTION IN THE
LITERATURE.
DIGITAL HEALTH, WE CAN DO MUCH
WITH THE TECHNOLOGY AVAILABLE TO
US.
OBVIOUSLY AI IS A BIG PIECE OF
THIS BUT WE ALSO WANT TO KNOW
HOW SENSORS AND VARIOUS KINDS OF
DIGITAL TECHNOLOGY CAN BE USED
TO UNDERSTAND AND CAPTURE
PEOPLE'S BEHAVIORS IN REAL TIME.
EVIDENCE BASED POLICY, OBVIOUSLY
SOME STRONG CONNECTIONS TO CRAN
PRIORITIES.
WE NEED TO SUPPORT EVIDENCE
BASED POLICY IN THE BEST WAY
POSSIBLE AND I'LL BE SAYING A
BIT ABOUT THE WORK THAT WE DO TO
SUPPORT FDA REGULATION OF
TOBACCO.
CLIMATE CHANGE AND CANCER, WHAT
DO THEY HAVE TO DO WITH EACH
OTHER?
BUT IT DOESN'T TAKE MUCH TO
THINK ABOUT HOW THESE MIGHT BE
CONNECTED.
CLIMATE EVENTS INFLUENCE CANCER
CARE IN SIGNIFICANT WAYS.
YOU CAN IMAGINE A HURRICANE, A
TORNADO CAN HAVE AN EFFECT ON
WHETHER A PATIENT CAN GET
ADEQUATE CARE BUT CLIMATE CHANGE
CAN INFLUENCE BEHAVIORAL RISK
FACTORS.
CLIMATE CHANGE AFFECTS THE FOOD
SUPPLY, WHICH CAN INFLUENCE
CANCER MORBIDITY AND MORTALITY.
NEXT SLIDE PLEASE.
SO THIS IS THE PROGRAM THAT I
LEAD AND MUCH OF THE WORK THAT
WE DO ON ADDICTION AND
PARTICULARLY TOBACCO CONTROL IS
HOUSED WITHIN THIS PROGRAM AT
THE NATIONAL CANCER INSTITUTE
AND THIS IS OUR LEADERSHIP TEAM
AND I ENCOURAGE YOU TO REACH OUT
TO ANY OF THEM IF YOU HAVE
QUESTIONS ABOUT TOPICS OF
INTEREST BUT I DO WANT TO
HIGHLIGHT THE LOWER RIGHT, WE
NOW HAVE A NEW BRANCH CHIEF.
MICHELLE BLOCK HAS SERVED IN
THIS ROLE OVER THE LAST TEN OR
SO YEARS AND MICHELLE IS ON THE
CALL SO I WANT TO THANK HER FOR
HER TREMENDOUS DEDICATION AND
CONTRIBUTIONS TO NCI AND NIH.
MICHELLE IS NOW FACING
RETIREMENT AND WE NOW HAVE NEAL
FRIEDMANN TAKING ON THE ROLE OF
THE BRANCH CHIEF OF TOBACCO
CONTROL.
NEAL COMES TO US FROM ANOTHER
PART OF NCI. HE WAS IN THE
METABOLIC EPIDEMIOLOGY BRANCH
AND HE'S MAKING THE SWITCH FROM
INTRAYURL TO EXTRAMURAL AND
WE'RE EXCITED TO HAVE HIM ON
BOARD IN THIS NEW ROLE.
HE ALREADY HAS A GREAT DEAL OF
KNOWLEDGE ABOUT TOBACCO AND
TOBACCO CONTROL AND ALSO OTHER
BEHAVIORS INCLUDING ALCOHOL AND
I THINK HE'S GOING TO DO A
REALLY TERRIFIC JOB HELPING US
THINK ABOUT WHERE ALCOHOL SITS
WITHIN THE WIDER LINKS TO CANCER
OUTCOMES.
NEXT SLIDE, PLEASE. NOW OUR
TOBACCO CONTROL RESEARCH BRANCH
HAS ENGAGED IN MANY ACTIVITIES
OVER THE YEARS.
WE HAVE A BIG GRANTS PORTFOLIO
AND I WILL BE MENTIONING SOME OF
OUR FUNDING OPPORTUNITIES BUT WE
DO A LOT OF OTHER WORK INCLUDING
AN IMPORTANT MONOGRAPH SERIES
THAT CONTINUES TO REALLY HAVE A
TREMENDOUS IMPACT ON POLICY AND
ON RESEARCH AND IN MANY
DIFFERENT VENUES.
AND SO THE MOST RECENT ONE WAS
TOBACCO MONOGRAPH 23 WHICH
FOCUSED ON SMOKING AND CANCER
PATIENTS.
THIS IS A VERY IMPORTANT
POPULATION. WE NOW KNOW THAT
CANCER SURVIVORSHIP IS NOT A
DEATH SENTENCE.
CANCER SURVIVORSHIP IS A
LONG-TERM EXPERIENCE AND THAT IS
BECAUSE OF ALL THE NEW CANCER
THERAPIES THAT HAVE DEVELOPED
OVER THE LAST 30, 40, 50 YEARS.
THERE ARE MANY PEOPLE WHO ARE
LIVING AFTER A CANCER DIAGNOSIS
EVEN MORE THAN BEFORE THE CANCER
DIAGNOSIS, SO WE NEED TO MAKE
SURE THAT WE ARE ATTENDING TO
THEIR NEEDS AND ONE OF THOSE IS
TO ADDRESS BEHAVIORS THAT -- AND
MANY CANCER SURVIVORS ARE
SMOKERS AND SO THIS MONOGRAPH
REALLY FOCUSES ON HOW TO ADDRESS
TOBACCO CESSATION IN THIS
PARTICULAR SUBPOPULATION THAT
REALLY NEEDS ATTENTION. AND IT
TURNS OUT THERE AREN'T A LOT OF
STUDIES THAT ADDRESS TOBACCO
CESSATION IN THE CANCER PATIENT
POPULATION.
BUT THERE'S A VERY RIFRP
LITERATURE ON APPROACHES THAT DO
WORK IN ADULTS MORE GENERALLY
AND THOSE HAVE NOW BEEN ADAPTED
TO CANCER PATIENTS AND ARE
INCREASINGLY BEING ADAPTED TO
CANCER PATIENTS.
I ENCOURAGE YOU TO TAKE A LOOK
AT THIS.
WE ARE NOW WORKING ON OUR NEXT
MONOGRAPH, THIS ONE WILL FOCUS
ON UNDERSTANDING THE EFFECTS OF
ALCOHOL USE ACROSS THE TOBACCO
CONTROL CONTINUUM.
WE'RE INCREASINGLY FINDING HOW
IMPORTANTLY THESE GO HAND IN
HAND AND SO THIS WILL ADDRESS A
NUMBER OF QUESTIONS INCLUDING
EPIDEMIOLOGICAL QUESTIONS AND UP
TO POLICY QUESTIONS AND WE'RE IN
THE PROCESS OF GETTING THAT
GOING.
NEXT SLIDE, PLEASE.
GREAT.
THANK YOU.
SO THE DEPARTMENT OF HEALTH AND
HUMAN SERVICES SPONSORS WHAT I
CONSIDER TO BE A REALLY CRUCIAL
TOOL TO FACILITATE SMOKING
CESSATION AND THAT IS SMOKE
FREE.GOV. IT IS A COLLABORATION
ACROSS SEVERAL FEDERAL AGENCIES
PARTICULARLY FDA AND CDC.
IT BUILDS ON THE PSYCHOLOGY OF
CESSATION WHICH REALLY
EMPHASIZES THE IMPORTANCE OF
FOCUSING ON THE POSITIVE AND NOT
SCARING PEOPLE AND SHAMING THEM
BUT GIVING THEM MOTIVATION TO
CONTINUE TO QUIT AND TO TRY TO
QUIT.
THIS IS A MOBILE BASED RESOURCES
THAT CAN BE ACCESSED BY SMOKERS
AT ANY TIME AND WE ALSO HAVE A
NUMBER OF DIFFERENT SMALLER
PIECES OF A SMOKE FREE SUITE
THAT FOCUS ON SPECIFIC
POPULATIONS SUCH AS ADOLESCENCE
AND MILITARY AND WOMEN AND SO
ON.
AND YOU CAN SEE HERE THAT WE'VE
REACHED 7 TO 8 MILLION PEOPLE IN
THE LAST YEAR, 2022.
SO IT'S A WIDELY USED RESOURCE
AND AN IMPORTANT ONE AND WE DO
WHAT WE CAN DO TRY TO REACH MANY
SUBPOPULATIONS AND ALSO WE TRY
TO KEEP UP THE CON TENTS TO MAKE
SURE IT'S AS UP TO DATE AS
POSSIBLE.
NEXT SLIDE, PLEASE.
NOW, OF COURSE AS I SAID BEFORE,
MUCH OF THE WORK THAT WE DO AND
ALSO NIDA AND THE SCIENCE
PROGRAM WITHIN THE OFFICE OF
DISEASE PREVENTION AT NIH, SO
FDA HAS PROPOSED PRODUCT
STANDARDS TO PROHIBIT MENTHOL AS
A CHARACTERIZING FLAVOR IN
CIGARETTES.
THAT'S A REALLY BIG DEAL.
WE'RE GOING TO SEE WHERE THAT
GOES.
THE PUBLIC COMMENT PERIOD HAS
NOW CLOSED AND THEY ARE
REVIEWING THOSE COMMENTS AND
DECIDING HOW TO MOVE FORWARD.
IT'S VERY CLEAR THAT WE'RE GOING
TO NEED SOME RESEARCH ON HOW
BEST TO FACILITATE CESSATION IN
COMMUNITIES, PARTICULARLY BLACK
COMMUNITIES WHERE MENTHOL IS
USED QUITE FREQUENTLY AND FOR
WHICH RESOURCES ARE NOT AS
AVAILABLE AS THEY SHOULD BE.
I HAVE ANIMATION ON THE SLIDE SO
IF YOU CAN GO TO THE NEXT
ANIMATION.
YOU MIGHT HAVE HEARD THE TERM
SYNTHETIC NICOTINE AND WE'VE NOW
MOVED TO THE TERM NONTOBACCO
NICOTINE.
SO IT'S NOT DERIVED FROM TOBACCO
AND THAT'S REALLY LED FDA TO
THINK ABOUT WHAT FALLS UNDER
THEIR DEFINITIONS.
WE NEED MUCH MORE RESEARCH ON
HOW PEOPLE USE NONTOBACCO
NICOTINE PRODUCTS AND WHAT THE
IMPACT WILL BE OVER TIME AND
THEN NEXT ANIMATION, THE FDA IS
ALSO WORKING TO DEVELOP A
PROPOSED PRODUCT STANDARD THAT
WOULD ESTABLISH A MAXIMUM
NICOTINE LEVEL.
THIS IS CONSIDERED TO BE AN END
GAME STRATEGY.
IF YOU REDUCE NICOTINE LEVELS
SUBSTANTIALLY IN CIGARETTES AND
OTHER TOBACCO PRODUCTS YOU CAN
IMAGINE THAT WILL REDUCE
ADDICTION AND THEN THEREFORE
REDUCE USE.
AND PROBABLY GET US TO A POINT
WHERE WE ARE DOING MUCH BETTER
IN TERMS OF USE AND THEN
ULTIMATE HEALTH IMPACT.
SO THESE ARE THREE FDA
INITIATIVES, THAT ARE VERY
IMPORTANT TO TRACK AND FOR WHICH
THEY NEED THE KINDS OF DATA THAT
WE SUPPORT AND WE SUPPORT
INVESTIGATORS TO DEVELOP.
NEXT SLIDE, PLEASE.
I WANT TO SAY A LITTLE BIT ABOUT
ALCOHOL.
YOU HEARD ME TALK ABOUT THIS
LAST YEAR AND THE YEAR BEFORE.
THIS IS SOMETHING THAT HAS BEEN
C
CAPTURING OUR IMAGINATION. THE
DATA HAS COME OUT SAYING ALCOHOL
IS A SIGNIFICANT RISK FACTOR FOR
CANCER.
BREAST CANCER AND COLORECTAL
CANCER WHICH ARE UP IN THE TOP
OF THE LIST SO REALLY IMPORTANT
TO ATTEND TO THESE.
YOU CAN SEE ON THE GRAPH ON THE
RIGHT THAT ALCOHOL IS NOW
CONSIDERED TO BE THE THIRD
LEADING MOD FINAL RISK FACTOR
FOR CANCER MORBIDITY AND
MORTALITY.
CIGARETTE SMOKING IS ALWAYS
NUMBER ONE AND FOLLOWED BY
EXCESSIVE BODY WEIGHT AND
ALCOHOL IS NUMBER THREE.
AND IT SEEMS TO BE THE CASE THAT
THE CARDIOVASCULAR STORY THAT
WE'VE BEEN HEARING FOR THE LAST
MANY DECADES IS STARTING TO
BREAK DOWN. THE FAMOUS J CURVE
THAT SUGGESTS THAT MODERATE
CONSUMPTION MIGHT BE HEALTHIER
THAN NO CONSUMPTION, THAT
DOESN'T SEEM TO BE WORKING OUT
WHEN YOU DO A DEEP DIVE INTO THE
DATA.
MANY PEOPLE WHO DON'T DRINK OR
FORMER DRINKERS OR PEOPLE WITH
HEALTH PROBLEMS WHO DON'T DRINK
BECAUSE OF THOSE HEALTH PROBLEMS
AND WHEN YOU PARSE ALL OF THAT
OUT THE CARDIOVASCULAR STORY
REALLY STARTS BREAKING DOWN.
THE RED WINE PIECE OF THE
MEDITERRANEAN DIET DOESN'T ADD
TO THE BENEFITS.
SO NEXT, SLIDE.
WE'VE BEEN ENGAGED IN THIS TOPIC
IN MANY DIFFERENT WAYS.
A NUMBER OF COMMENTARIES,
COLLECTIVE DATA, WE HAVE HAD A
BIG MAJOR MEETING BRINGING
INVESTIGATORS TO THE TABLE
INCLUDING PEOPLE IN THE CANCER
COMMUNITY BUT ALSO THE ALCOHOL
CANCER AND REALLY WANT TO THANK
NIAAA FOR THEIR ENGAGEMENT AND
MANY OTHER ACTIVITIES WE'VE BEEN
INVOLVEMENT IN THIS SPACE.
WE HAVE A COUPLE OF RELEVANT
FUNDING OPPORTUNITIES BUT I'LL
TELL YOU THE BOOTTOM LINE IS WE
HAVE A VERY SMOUL PORTFOLIO ON
ALCOHOL AND CANCER AND WE HOPE
TO DO BETTER AT THAT AND WE'RE
HOPING TO ENGAGE THE COMMUNITY
IN DOING MORE WORK IN THIS
SPACE.
NEXT SLIDE.
ONE THING I DO REALLY WANT TO
HIGHLIGHT IS THAT DESPITE
ALCOHOL BEING A SIGNIFICANT RISK
FACTOR FOR CANCER, AWARENESS OF
ALCOHOL AS A RISK FACTOR IS
REALLY QUITE LOW.
SO WHEN I SHOW YOU ON THE RIGHT
HERE IS A GRAPH TAKEN FROM A
PAPER WE PUBLISHED USING DATA
FROM THE HEALTH INFORMATIONAL
HEALTH SURVEY WHICH IS A SURVEY
WE CONDUCT ON AN EVERY OTHER
YEAR BASIS.
ONE OF THE QUESTIONS ON A RECENT
SURVEY WAS WHETHER ALCOHOL WAS A
RISK FACTOR FOR CANCER AND WE
INCLUDED A DON'T KNOW OPTION
WHICH BY THE WAY IS MANY HAVE
SUGGESTED WE DO IN OUR SURVEYS
BECAUSE IF YOU DON'T HAVE A
DON'T KNOW OPTION PEOPLE DON'T
KNOW WHAT TO DO AND THEY JUST
MAKE UP AN ANSWER OR CHOOSE
SOMETHING IN THE MIDDLE WHICH
REALLY CAN GUM UP YOUR RESULTS
AND MAKE THEM UNINTERPRETABLE.
YOU CAN SEE THAT WAS THE MOST
FREQUENT OPTION SELECTED.
SO 55% ARE SAYING THEY DON'T
KNOW WHETHER ALCOHOL IS A RISK
FACTOR FOR CANCER AND A
NONTRIVIAL PEOPLE ARE SAYING
THAT ALCOHOL DECREASES THE RISK
OF CANCER SO YOU CAN SEE IN THE
THIRD SET OF BARS, THE BLUE ONE,
THAT'S WHY.
AND ABOUT 10% OF THE POPULATION
THINKS WINE DECREASES CANCER
RISK.
IT'S A NONTRIVIAL PERCENTAGE OF
AMERICANS AND SO WE HAVE
AWARENESS PROBLEMS HERE AND
THOSE NEED TO BE ADDRESSED.
NEXT SLIDE, PLEASE.
NOW, OF COURSE CANNABIS IS NOW
PART OF THE LANDSCAPE AND NORA
DID A GREAT JOB OF SUMMARIZING
WHERE THAT STANDS.
SHE TALKED ABOUT AND SHE SHOWED
A PIC OF THE UNITED STATES AND
AS YOU CAN SEE 38 DIFFERENT
STATES ALLOW USE OF CANNABIS
PRODUCTS AND 23 STATES HAVE
ENACTED CANNABIS FOR ADULT
NONMEDICAL USE.
WE NEED TO PAY ATTENTION TO IT.
WE NEED TO THINK ABOUT COUSE, WE
NEED TO THINK ABOUT CANNABIS AS
A GATEWAY TO TOBACCO USE AND
ALSO LOOK AT THAT ACROSS THE
ENTIRE LIFE SPAN.
SO THE NATIONAL ACADEMIES HAS
PAID ATTENTION TO THIS AND HAD A
REPORT ON CANNABIS AND IS NOW
WORKING ON A NEW ONE THAT WE'RE
CONTRIBUTING TO WHICH IS
TENTATIVELY SCHEDULED FOR 2024
RELEASE.
AND YOU CAN SEE HERE THERE'S A
BIT OF ATTENTION IN THAT
CANNABIS IS STUDIED AND
CONSIDERED AND THOUGHT ABOUT IN
THE CONTEXT OF CANCER CARE,
RIGHT, THERE'S A PALLIATIVE
MEDICINE AND PART OF PALLIATIVE
CARE BUT ALSO IT'S A SUBSTANCE
THAT CAN BE USED ALONG WITH
TOBACCO WHICH INCREASES CANCER
RISK SO WHICH OF THOSE TWO
SHOULD WE FOCUS ON THE MOST?
PROBABLY BOTH OF THEM BUT
THEY'RE GOING TO REQUIRE
DIFFERENT KINDS OF APPROACHES
AND DIFFERENT RESEARCH
QUESTIONS.
NEXT SLIDE, PLEASE.
I WANT TO WIND UP BY JUST
MENTIONING A COUPLE OF KEY
FUNDING INITIATIVES THAT WE HAVE
PUT OUT THAT WE THINK ADDRESS
CSIGNIFICANT GAPS IN THE
LITERATURE.
BY THE WAY, YOU PROBABLY ARE
AWARE OF THE FACT THAT
CIGARETTES ARE NOT THE BIG
PROBLEM HERE WITH ADOLESCENTS.
IT'S NO SURPRISE, I THINK WE ALL
KNOW THAT MOST OF WHAT'S
HAPPENING IN THE ADDLESS SENT
POPULATION THANKS TO WORK THAT
HAS BEEN SUPPORTED BY NIDA AND
NCI AND OTHER INSTITUTES WE KNOW
NOW THAT ADOLESCENTS ARE USING
VAPING PRODUCTS AND GETTING
ADDICTED TO VAPING PRODUCTS AND
HAVING TROUBLE WITH CESSATION
FROM THOSE VAPING PRODUCTS.
WHAT WE'RE FINDING IS THAT MANY
OF THE TRADITIONAL CONVENTIONAL
SUCCESSFUL APPROACHES TO
CESSATION IN ADULTS, SO
PHARMACOLOGICAL APPROACHES ARE
JUST NOT WORKING WITH ADDLEOLEST
POPULATIONS.
THE FACT OF THE MATTER IS THAT
ADOLESCENT BRAIN DEVELOPMENT
JUST LOOKS DIFFERENT.
THEY'RE FROM A DIFFERENT PLANET
AND THEIR BRAINS JUST LOOK
DIFFERENT THAN ADULTS' DO AND WE
KNOW THAT FROM A LOT OF WORK
SUPPORTED BY NIDA AND OTHER
AGENCIES AND SO WE NEED
DIFFERENT APPROACHES TO
CESSATION AND SO WE'VE PUT OUT
THIS RFA ON TOBACCO CESSATION
INTERVENTION RESEARCH AND THE
EXPIRATION DATE IS COMING UP IN
OCTOBER AND NIDA IS WORKING WITH
US ON THIS.
WE REALLY HOPE WE'LL GET SOME
STRONG APPLICATIONS THAT WILL
CONSIDER SOME INNOVATIVE
APPROACHES TO CESSATION WITH
THIS VERY IMPORTANT POPULATION
THAT'S GETTING MORE AND MORE
INTERESTED IN VAPING AND MANY OF
THEM ARE GOING FROM VAPING
DIRECTLY TO CIGARETTE USE.
WE KNOW THAT FROM HALF DATA AND
FROM OTHER DATA SETS AND SO THIS
IS OF COURSE AN ALARMING
PROBLEM.
YOU CAN SEE THAT THERE ARE A
NUMBER OF DIFFERENT KINDS OF
STUDIES.
SO THOSE THAT PROMOTE CESSATION
OF NONCIGARETTE TOBACCO
PRODUCTS.
AND YOU CAN SEE SOME EXAMPLES OF
GROUPS THERE AT THE BOTTOM.
WE ALSO HAVE BEEN INTERESTED IN
TOBACCO AND CANNABIS AND LAST
YEAR WE POSTED A SUPPLEMENTAL
OPPORTUNITY AND GOT REALLY
STRONG APPLICATIONS AND YOU CAN
SEE THE TITLES OF THE PROJECTS
THAT WE WERE ABLE TO SUPPORT.
WE ARE VERY INTERESTED IN WHAT
THE OUTCOMES ARE OF COUSE AND
WE'RE GOING TO CONTINUE TO BE
PLAYING IN THE SPACE AND SO WE
HOPE THOSE OF YOU WHO ARE
ENGAGED IN THIS WORK AND YOUR
COLLEAGUES WILL PAY ATTENTION TO
THESE OPPORTUNITIES.
NEXT SLIDE, PLEASE.
I'M NOT GOING TO GO THROUGH THE
NEXT TWO SLIDES VERY CLOSELY,
BUT JUST WANT TO HIGHLIGHT THAT
WE HAVE A NUMBER OF FUNDING
OPPORTUNITIES VERY RELEVANT TO
THE PRIORITIES OF CRAN FOCUSING
ON POLICY, FOCUSING ON
CESSATION, FOCUSING ON QUESTIONS
AND ALL OF THESE ARE ADDRESSING
TOBACCO CONTROL BUT ALSO GET
INTO THE ALCOHOL SPACE AND THE
CANNABIS SPACE.
NEXT SLIDE, PLEASE.
THIS IS AN ADDITIONAL LIST OF
DIFFERENT OPPORTUNITIES AND I
HOPE YOU'LL TAKE ADVANTAGE OF
THEM AND I BELIEVE THE SLIDES
WILL BE MADE AVAILABLE SO YOU
CAN TAKE A CLOSER LOOK AT THESE
AND IF YOU DON'T GET ACCESS TO
THE SLIDES, WE DO HAVE A PRETTY
NIFTY WEBSITE THAT LISTS ALL OUR
FUNDING OPPORTUNITIES.
I ENCOURAGE YOU TO TAKE A LOOK
AT THAT.
IF YOU GOOGLE THAT YOU'LL GET
RIGHT TO OUR FUNDING
OPPORTUNITIES AND YOU'LL SEE ALL
OF THEM.
AND WE TRY VERY HARD TO USE AS
MANY DIFFERENT KINDS OF
MECHANISMS AS POSSIBLE.
RFAS, PARS WHICH ARE PROGRAM
ANNOUNCEMENTS WITH SPECIAL
REVIEW TYPICALLY, NOTICES OF
SPECIAL INTEREST, WE REALLY DO
TRY TO USE MULTIPLE DIFFERENT
MECHANISMS AND WE HOPE THERE ARE
EXTRAMURAL COMMUNITY PAYS
ATTENTION TO THEM.
NEXT SLIDE, PLEASE. I ALSO WANT
TO MENTION THAT WE HAVE A NUMBER
OF RESOURCES AVAILABLE TO THE
EXTRAMURAL COMMUNITY.
ONE OF THEM IS A BIG NATIONAL
SURVEY THAT I'VE MENTIONED
ALREADY.
THE HEALTH INFORMATION NATIONAL
TREND SURVEY.
AND WE MAKE OUR DATA PUBLICLY
AVAILABLE AS SOON AS WE CLEAN
THEM UP AND MAKE SURE THEY'RE
READY TO BE USED AND WE HAVE A
NUMBER F ITERATIONS OF OUR
SURVEY ONLINE FOR PEOPLE TO
DOWNLOAD.
WE DID A SPECIAL HINTS SURVEY
WITH OVER 1,000 CANCER
SURVIVORS.
ONE OF THE MOST COMMON COMMENTS
FROM THE COMMUNITY WAS THAT WE
WEREN'T COLLECTING ENOUGH DATA
FROM CANCER SURVIVORS AND SO WE
DO THAT NOW AND THERE ARE MANY
QUESTIONS ABOUT TOBACCO USE AND
ALSO OTHER SUBSTANCES ON THAT
SURVEY INCLUDING ALCOHOL.
AND SO I ENCOURAGE YOU TO TAKE A
LOOK AT THAT WEBSITE. I FIND
ACTUALLY THAT GRADUATE STUDENTS
AND POST DOCS LOVE TO USE OUR
HINTS DATA BECAUSE IT'S EASY TO
DOWNLOAD AND PUBLISH PRETTY
QUICKLY AND THERE'S SOME VERY
IMPORTANT SQUESTIONS ON THESE
SURVEYS. ALSO WANT TO HIGHLIGHT
THAT WE SUPPORT THE TOBACCO USE
SUPPLEMENT TO THE POPULATION
SURVEY WHICH IS LINKED TO THE
U.S. CENSUS AND THESE DATA ARE
ALSO PUBLICLY AVAILABLE AND WE
STRONGLY ENCOURAGE THE COMMUNITY
TO ACCESS THESE DATA.
WE HAVE A TEAM, A REALLY STRONG
TEAM WITHIN NCI THAT HELPS
PRODUCE THE ITEMS THAT GO ON TO
SUPPLEMENT AND ALSO HELP CUE
RATE THE DATA SO THAT OUR
COMMUNITY CAN USE THEM.
I WANT TO STRONGLY ENCOURAGE YOU
TO CONNECT WITH OUR WEBSITE, OUR
TWITTER FEED, OUR NEWSLETTER
JUST TO KEEP UP WITH WHAT WE'RE
DOING IN TERMS OF FUNDING
INITIATIVES AND PRIORITY SETTING
AND STRATEGIC PLANNING.
WE'RE CONSTANTLY WORKING ON
ACTIVITIES RELATED TO CRAN
PRIORITIES.
I KNOW TIME IS LIMITED BUT WE'RE
ALWAYS HAPPY TO TALK TO
INVESTIGATORS ABOUT ANY OF OUR
IDEAS, ANYTHING THAT WE'RE
TALKING ABOUT INTERNALLY AND
CLEARLY, THE LANDSCAPE IS
CHANGING.
WE'RE SPENDING LOTS OF TIME
THINKING ABOUT COVID-19 AND THE
RISKS OF CANCER AND ON AND ON.
SO MUCH HAS HAPPENED OVER THE
LAST THREE TO FIVE YEARS THAT
HAS AN IMPACT ON CANCER CONTROL
AND THAT KEEPS US UP AT NIGHTS
AND KEEPS US BUSY DEVELOPING NEW
FUNDING INITIATIVES.
SO WITH THAT I WILL END AND TURN
THINGS BACK OVER TO GEORGE.
>>THANK YOU, BILL.
THAT WAS GRADE.
AND I WANT TO THANK BOTH NORA
AND BILL FOR REALLY WONDERFUL
TALKS THAT COMPREHENSIVELY
OUTLINE SOME OF THE CHALLENGES
WE FACE.
THE SLIDES WILL BE AVAILABLE ON
THE NIH WEBSITE, SO THOSE OF YOU
WHO WANTED TO GET SOME OF THIS
INFORMATION AND UTILIZE IT,
YOU'LL BE ABLE TO FIND IT THERE.
OKAY.
SO I'M GOING TO TURN IT OVER TO
NORA WHO'S GOING TO INTRODUCE
DR. GAL GAL AND THE ABCD TEAM.
>>IT'S A PLEASURE FOR ME TO DO
THIS BECAUSE I THINK THAT THIS
PROJECT IS PERHAPS THE MOST
NOTABLE AND SALIENT THAT HAS
COME OUT OF THE CRAN INITIATIVE
AND BASICALLY HAS RESULTED IN AN
OUTCOME THAT WE NEVER ACTUALLY
WERE PREDICTING WAS GOING TO BE
SO SPECTACULAR AND THIS IS
POSSIBLE BECAUSE OF THE
EXTRAORDINARY LEADERSHIP THAT
DR. GAYATHRI DOWLING HAS HAD
OVER THE YEARS SINCE IT STARTED
AND SHE WILL BE GIVING US AN
UPDATE AND IT ALSO WOULDN'T HAVE
BEEN POSSIBLE WITHOUT THE
SUPPORT ALL ALONG OF DR. GEORGE
KOOB, SO IT HAS BEEN POSSIBLE
BECAUSE OF ALL OF THESE PEOPLE
AND THEIR COMING TOGETHER AND
THEIR FOLLOWING UP THAT IS VERY
RELEVANT.
HOW DOES THE HUMAN BRAIN DEVELOP
AND HOW IT IS AFFECTED.
SO GAYATHRI, PLEASE JUMP IN.
>>THANK YOU FOR THE OPPORTUNITY
TO SPEAK ABOUT ABCD AGAIN THIS YEAR
I WANTED TO JUST START BY
REINTRODUCING AND INTRODUCING
SOME NEW MEMBERS OF OUR TEAM.
IN THE PAST YOU'VE HEARD MEMBERS
OF THE ABCD TEAM AT NIDA AND
YOU'LL BE HEARING A LITTLE BIT
MORE FROM THEM TODAY AND THEY'LL
BE HIGHLIGHTED THROUGHOUT THE
PRESENTATION FOR A NUMBER OF
THINGS THAT THEY CONTRIBUTE TO
THE STUDY.
BUT I ALSO WANTED TO INTRODUCE
TWO NEW MEMBERS TO THE TEAM
SINCE THE LAST TIME I WAS HERE.
DR. DIANA JOINED NIDA AS A
PROGRAM ANALYST FOR ABCD AND SHE
EVERYBODIED HER PH.D. IN
NEUROSCIENCE AND COGNITIVE
SCIENCE AND DID HER POST
DOCTORAL TRAINING WHERE SHE
CONDUCTED RESEARCH ON SOCIAL
COGNITION AND AUTISTIC AND
TYPICALLY DEVELOPING YOUTH.
SHE IS REALLY MOST NOTABLY BEEN
LEADING RETENTION DATA CORE
WHICH I'LL TALK A LITTLE BIT
ABOUT AND CONDUCTING SOME
PORTFOLIO ANALYSIS THAT YOU'LL
SEE MORE ABOUT TODAY.
AND THEN I'D ALSO LIKE TO
INTRODUCE TRACI MURRAY WHO HAS
JOINED NIDA AS A SCIENTIFIC
ADVISOR FOR DIVERSITY EQUITY AND
INCLUSION.
SHE EARNED HER PH.D. AT THE
UNIVERSITY OF TEXAS AT TYLER AND
HER MASTER'S IN PUBLIC HEALTH AT
THE UNIVERSITY OF NORTH TEXAS
HEALTH SCIENCES CENTER.
SHE SPENT NEARLY THREE YEARS
WITH THE INDIAN HEALTH SERVICE
SERVING THE TRIBE OF NEBRASKA
AND SHE SERVED AS REGIONAL
ADMINISTRATOR FOR THE HEALTH
SERVICES ADMINISTRATION IN
DALLAS.
SHE'LL BE SPEAKING A LITTLE BIT
LATER ABOUT SOME OF THE
INITIATIVES IN HER REALM.
SO AS ALWAYS IT'S HARD TO SELECT
WHAT TO BRING INTO CRAN COUNCIL
TO TALK ABOUT FOR ABCD, SO
HERE'S A QUICK OUTLINE OF WHAT I
WANT TO TALK ABOUT.
RETENTION PRIORITIES AND
STRATEGIES AS THAT'S ALWAYS VERY
IMPORTANT FOR A LONGITUDINAL
STUDY.
SOME UPDATES ON DATA AND BIO
SPECIMEN SHARING. I'D LIKE TO
TALK ABOUT SOME OF THE OUTCOMES
WE'RE SEEING FROM THE ABCD STORY
AND KIM WILL HIGHLIGHT A COUPLE
OF PAPERS IN THAT REGARD.
TRACI MURRAY WILL GIVE AN UPDATE
AND ELIZABETH HOFFMAN WILL
HIGHLIGHT A PAPER THAT SHOWS
SOME OF THAT WORK AND I'LL
CONCLUDE WITH RESEARCH
DISSEMINATION IN THE STUDY.
SO FOR RETENTION WE'RE ALWAYS
VERY EXCITED TO SHOW THAT THE
STUDY OVERALL IS DOING VERY WELL
AT RETAINING OUR CLOSE TO 12,000
YOUTH.
WE HAVE 97% THAT HAVE --
CONTINUE TO BE PART OF THE
STUDY.
THEY HAVEN'T OFFICIALLY WITH
DRAWN FROM THE STUDY.
THIS FIGURE SHOWS HOW MANY
PARTICIPANTS HAVE COMPLETED EACH
OF THE TIME POINTS SO JUST TO
REFRESH YOUR MEMORY WE SEE
EVERYBODY IN PERSON ANNUALLY AND
THEN IN THE MID YEAR WE HAVE A
PHONE TOUCH BASE SO THIS SHOWS
ALL OF THE DATA TIME POINTS.
YOU CAN SEE OUR COVID BLIP HERE
AND WE ARE STILL IN THE PROCESS
OF KIND OF TRYING TO RECOVER OUR
TRAJECTORIES FOR ALL OF OUR TIME
POINTS FROM COVID TO MAKE SURE
THAT WE'RE SEEING EVERYBODY IN
PERSON AND GETTING EVERYBODY
BACK ON SCHEDULE FROM WHEN SITES
WERE CLOSED DOWN.
BUT THERE ARE A COUPLE OF AREAS
THAT ARE OF PARTICULAR FOCUS FOR
US IN TERMS OF ENSURING THAT WE
RETAIN THE FULL DIVERSE COHORT.
ONE IS LOW INCOME FAMILIES.
YOU CAN SEE FROM THIS FIGURE,
THIS IS FROM OUR FOUR-YEAR
FOLLOWUP, THAT -- AND THE ORANGE
ARE PEOPLE WHO HAVE MISSED A
VISIT AND YOU CAN SEE THERE'S A
GREATER PROPORTION OF FAMILIES
WHOSE HOUSEHOLD INCOME IS LESS
THAN $50,000 IN THAT MISSED
CATEGORY. SO THIS IS A
SIGNIFICANT AREA OF FOCUS FOR
OUR RETENTION GROUPS AND I'LL
SPEAK TO THAT A LITTLE BIT MORE
IN A MOMENT.
ANOTHER AREA OF FOCUS IS REMOTE
VISITS.
WHEN THE PANDEMIC HIT, WE OF
COURSE WENT FULLY REMOTE FOR
EVERYTHING, BUT AS SITES OPENED
UP, WE CONTINUED TO SEE MANY
FAMILIES WANTING TO CONTINUE TO
DO THEIR VISITS REMOTELY.
AND SO THERE'S BEEN A REAL PUSH
LATELY TO RETURN EVERYBODY TO IN
PERSON VISITS BECAUSE THE REMOTE
VISITS ARE PARTICULARLY
PROBLEMATIC I THINK FOR THE --
EVEN YOUR VISITS WHERE WE HAVE
THE NEURO IMAGING BUT IT'S ALSO
IMPORTANT FOR THE ODD YEAR
VISITS BECAUSE WE DO COLLECT
SPECIMENS THAT WE AREN'T ABLE TO
DO REMOTELY.
WE'RE REALLY STRONGLY PUSHING TO
HAVE EVERYBODY COME IN PERSON OR
AT LEAST HYBRID.
THAT IS THEY'LL COME IN FOR THE
IMAGING AND THE BIO SPECIMENS
BUT CAN DO THE REST OF THE
ASSESSMENT REMOTELY.
AND THEN THE -- ANOTHER MAJOR
AREA OF FOCUS IS THIS CATEGORY
THAT WE'RE CALLING POTENTIAL
WITH DRAW.
SO LIKE I SAID, IN TERMS OF
RETENTION WE HAVE FAMILIES THAT
HAVE OFFICIALLY WITHDRAWN.
THESE ARE FAMILIES THAT HAVE NOT
OFFICIALLY WITHDRAWN BUT WE
HAVEN'T SEEN THEM SINCE THEIR
TWO-YEAR FOLLOWUP.
AND SO WE FEEL THAT THESE ARE
THE MOST AT RISK FAMILIES AND WE
HAVE THESE METRICS THAT IDENTIFY
PEOPLE THAT ARE AT GREATEST RISK
AND WE'RE TRYING TO UNDERSTAND
WHY THAT IS AND WHAT WE CAN DO
ABOUT THAT.
AND TO THAT END WE ARE REALLY
TRYING TO TAKE A DATA DRIVEN
APPROACH TO RETENTION.
ALL ALONG YOU'VE HEARD ME TALK
ABOUT THE METRICS THAT WE'RE
USING TO TRACK RECRUITMENT AND
RETENTION BUT WE'RE KIND OF
STEPPING THAT UP A LEVEL NOW AND
WITH DIANA'S INVOLVEMENT, SHE'S
NOW LEADING THIS RETENTION DATA
CORE THAT WORKS WITH ALL OF
THESE OTHER SUBGROUPS IN OUR
ATTENTION WORK GROUP TO ANALYZE
DATA, TO HELP US GIVE US MORE
INFORMATION ABOUT WHO'S MOST AT
RISK, WHY THEY'RE MOST AT RISK
AND HOPEFULLY INFORM STRATEGIES
TO BRING THEM BACK INTO THE
STUDY.
SO WE COLLECT FEEDBACK FROM
FAMILIES AT THE END OF EVERY
VISIT.
SHE'S BEEN LOOKING AT
RELATIONSHIPS BETWEEN THE
FEEDBACK WE'RE GETTING AND THE
REASONS THAT PEOPLE ARE
WITHDRAWING OR MISSING VISITS.
WE'RE ALSO COLLECTING
INFORMATION FROM OUR SITES ON
WHAT PRACTICES THEY EMPLOY TO
RETAIN PARTICIPANTS AND SHE AND
THE GROUP ARE GOING TO BE DOING
SOME CORRELATIONS BETWEEN THOSE
PRACTICES AND RETENTION METS
RICKS TO SEE WHICH ONES ARE
PRODUCING THE BEST RESULTS.
AND WE'VE DONE PREDICTIVE
MODELLING THROUGHOUT THE STUDY
BUT WE'RE REALLY RAMPING THAT UP
AS WELL NOW TO UNDERSTAND -- TO
REALLY BE ABLE TO IDENTIFY WHO
THE MOST AT RISK OF BEING LOST
TO THE STUDY.
AND WE HOPE THAT THESE ANALYSIS
THAT THE DATA CORE ARE PLANNING
WILL HELP TO INFORM THE OTHER
RETENTION SUBGROUPS TO DEVELOP
ACTION TO ADDRESS THESE.
SO FOR EXAMPLE, WE -- THROUGH
LOOKING AT THE BEST PRACTICES
WE'RE LOOKING AT DIFFERENT
COMPENSATION MODELS ACROSS THE
CONSORTIUM, LOOKING AT DIFFERENT
STAFFING MODELS TO SEE WHAT
IS -- WHAT IS WORKING BEST.
WE'RE ALSO RAMPING UP SOME OF
OUR ENGAGEMENT EFFORTS SO WE
HAVE A NEW SUBGROUP AND
RETENTION CALLED THE
RECONNECTING WITH PARTICIPANTS
AND THEY'RE REALLY FOCUSED ON
THAT RETENTION WITHDRAWAL GROUP
AND DISCUSSING TARGETED OUTREACH
TO GROUPS THAT ARE MOST AT RISK
OF WITHDRAWING.
WE'RE ALSO DOING MORE ENGAGEMENT
WITH OUR FAMILIES.
SO LED BY ELIZABETH HOFFMAN
WE'RE DEVELOPING SOME THANK YOU
VIDEOS THAT ARE MORE IN STYLE
FOR THE YOUTH PARTICIPANTS AS
THEY ARE GETTING A LITTLE BIT
OLDER.
WE'RE DEVELOPING EDUCATIONAL
MATERIALS AND I'LL TALK A LITTLE
BIT MORE ABOUT THAT AT THE END.
WE'RE ALSO DEVELOPING RESOURCES
FOR YOUTH SO HOW CAN THEY
LEVERAGE THEIR PARTICIPATION IN
ABCD IN APPLYING FOR JOBS OR
COLLEGE AND GIVING THEM THE
LANGUAGE THEY CAN USE TO
INCORPORATE THOSE IN THEIR
APPLICATIONS.
SO NOW I'D LIKE TO TRANSITION TO
BIO DATA AND BIO SPECIMEN
SHARING IN ABCD.
I'M SURE MANY OF YOU ARE AWARE
THAT OUR RELEASE OF THE 5.0 DATA
HAS BEEN DELAYED AND THIS WAS
DUE TO SOME UNFORESEEN ISSUES
WITH SECURITY REQUIREMENTS AND
NOT BEING ABLE TO RELEASE THE
DATA ANALYSIS PORTAL THE WAY WE
INTENDED.
SO WE'RE REVAMPING THE WAY WE
WILL RELEASE IT.
IT WILL STILL BE IN THE NIH DATA
ARCHIVE AND ALL OF IT WILL BE IN
THE ABCD COLLECTION PAGE IN THE
NDA.
THE TAB LATED DATA INSTEAD OF
BEING AVAILABLE THROUGH THE NDA
DATABASE WILL BE STORED IN ZIP
FILES THAT CAN BE DOWNLOADED.
SO BECAUSE OF THAT, I'M NOT --
YOU WON'T BE ABLE TO FILTER THE
DATA STRUCTURE BUT THE ABCD DATA
TEAM IS DEVELOPING DATA
DICTIONARY EXPLORER TO HELP
PEOPLE IDENTIFY WHAT MEASURES
THAT THEY'RE LOOKING FOR SO WE
WILL HAVE THAT FEATURE THAT WAS
PART -- USED TO BE PART OF THE
DATA EXPLORATION ANALYSIS PORTAL
WHICH WON'T BE AVAILABLE BUT
THAT WILL BE AVAILABLE IN THIS
NEW APPLICATION.
AND THEN MOVING FORWARD, IN
TERMS OF DATA RELEASES, IN
FEBRUARY OF THIS YEAR, NIDA
COUNCIL APPROVED CONCEPT FOR NEW
DATA SHARING PLATFORM THAT WE'RE
HOPING WILL BE AVAILABLE FOR THE
6.0 RELEASE NEXT YEAR. WE ALSO
WANT TO MAKE AVAILABLE THE BIO
SPECIMENS THAT ARE COLLECTED IN
THE ABCD STUDY AND THIS IS
SOMETHING WE'VE BEEN TALKING
ABOUT FOR A LONG TIME BUT IT'S
COMING TO FRUITION HOPEFULLY
VERY SOON.
SO AS YOU KNOW, WE COLLECT HAIR
SAMPLES, SALIVA, BABY TEETH, WE
HAVE DNA THAT'S BEEN EXTRACTED
FROM SALIVA.
WHOLE BLOOD SERUM.
WE COLLECT THESE, MANY OF WHICH
ARE ANALYZED TO DO CERTAIN
ANALYSIS AND THEN THE RESIDUALS
HAVE BEEN STORED IN A NUMBER OF
DIFFERENT LOCATION.
AND THE PLAN HAS ALWAYS BEEN TO
MAKE AVAILABLE TO THE SCIENTIFIC
COMMUNITY FOR ADDITIONAL
RESEARCH.
I THINK EARLIER THIS YEAR WE
PUBLISHED A NOTICE OF INTENT TO
PUBLISH OF A FUNDING OPPORTUNITY
ANNOUNCEMENT WHICH IS A MISNOMER
FOR THIS PROGRAM FOR A BIO
SPECIMEN ACCESS PROGRAM THAT
WILL UTILIZE THE XO1 MECHANISM
FOR PEOPLE TO APPLY FOR ACCESS
TO THESE SPECIMENS.
TO DO RESEARCH THAT'S CONSISTENT
WITH THE ABCD STUDY OBJECTS OR
ADDLESS SENT HEALTH MORE
BROADLY.
THIS IS ONLY TO GET ACCESS TO
THE SPECIMENS.
IT DOES NOT PROVIDE FUNDING.
SO WE EXPECT THAT PEOPLE WHO
APPLY FOR ACCESS TO THESE
SPECIMENS WILL HAVE FUNDING FROM
ANOTHER SOURCE AND WILL HAVE TO
DEMONSTRATE THAT IN THEIR
APPLICATIONS.
WE WILL SOON HAVE A BIO SPECIMEN
EXPLORER WHERE PEOPLE WILL GO IN
AND SEE WHAT SPECIMENS WE HAVE
BY DEMOGRAPHICS SO THEY CAN THEN
DETERMINE WHAT IS NEEDED FOR
THEIR RESEARCH.
ONE EXCEPTION TO WHAT WILL BE
AVAILABLE IN -- IMMEDIATELY ARE
SPECIMENS FROM PARTICIPANTS WHO
SELF-IDENTIFY AS AMERICAN I
UNDERSTAND -- INDIAN, ALASKA
NATIVE.
NOW I'D LIKE TO TRANSITION TO
SOME OF THE EXCITING OUTCOMES
FROM THE STUDY.
SO I'VE USED THIS SLIDE MANY
TIMES BEFORE TO TALK ABOUT WHAT
OUR VISION IS FOR HOW ABCD DATA
IS GOING TO BE USED.
OF COURSE WE HAVE RESEARCH
QUESTIONS THAT WE STARTED OFF
WITH BUT WE KNOW THERE ARE MANY
OTHER RESEARCH QUESTIONS THAT
PEOPLE ARE INTERESTED IN AND
WHAT WE FOUND IS THAT IT'S --
THE DATA SET HAS BECOME VERY
POPULAR SO DIANA HAS DONE AN
ANALYSIS OF THE PORTFOLIO OF
GRANTS THAT HAVE BEEN FUNDED
ACROSS NIH AND ACTUALLY BEYOND
NIH USING ABCD DATA OVER TIME
AND NIH HAS NOW FUNDED 154
GRANDS USING THE DATA COVERING A
NUMBER OF DIFFERENT AREAS AS YOU
CAN SEE IN THIS DIAGRAM.
WHAT'S REALLY EXCITING IS THAT
THERE HAVE BEEN 14 INSTITUTES
AND CENTERS AT NIH THAT HAVE
FUNDED THESE GRANTS SO THAT'S
BEYOND THE TEN ICS THAT ARE
SUPPORTING ABCD IT'S REALLY
ENGAGED THE INTERESTS OF ICS
ACROSS THE NIH AS WELL AS
NON-NIH FUNDERS WHO ARE ALSO
SUPPORTING RESEARCH USING ABCD
DATA.
IN TERMS OF THE MECHANISMS THAT
ARE BEING FUNDED, THE MAJORITY
OF THESE ARE RESEARCH GRANTS,
BUT ALSO QUITE A NUMBER OF
INDIVIDUAL TRAINING GRANTS AND
THIS HAS GONE UP OVER TIME
ALTHOUGH THERE WAS A SLIGHT DIP
IN TRAINING IN 2022.
I KNOW IT'S HARD TO SEE HERE.
READ ALL OF THE LABELS HERE BUT
I JUST WANTED TO SHOW KIND OF A
QUICK IMAGE TO DESCRIBE THE MANY
DIFFERENT AREAS THAT ARE BEING
COVERED BY THIS.
SO THIS IS THAT ADDITIONAL
RESEARCH QUESTIONS AND WE HAVE
ANNOUNCEMENTS FOR PEOPLE TO USE
ABCD DATA ANALYSIS BUT THESE
GRANTS ARE COMING IN LIKE I
SAID, FROM MANY ICS IN RESPONSE
RFAS THAT ARE NOT ASSOCIATED
WITH ABCD AT ALL SO IT'S REALLY
BROADENING THE USE OF ABCD DATA.
ANOTHER THING THAT WE WANTED TO
LOOK AT IS HOW PEOPLE ARE USING
OR WHAT ARE THEY USING ABCD FOR.
SO WE LOOKED AT WHETHER THEY'RE
USING THE DATA, WHETHER THEY'RE
USING THE METHODS WHICH I THINK
IS ALSO AN OUTCOME FROM ABCD
THAT WE'VE DEVELOPED METHODS
THAT OTHERS ARE NOW ADOPTING AND
THAT REALLY GOES TOWARDS BEING
ABLE TO HARMONIZE ACROSS
STUDIES.
AND LOOK AT WHAT IS REALLY --
THIS IS KIND OF A QUICK OVERVIEW
OF WHAT WE'RE SEEING, SO PEOPLE
ARE DEFINITELY USING ABCD DATA
TO DEVELOP METHODOLOGIES, AND
ANALYSIS TOOLS, PEOPLE ARE
POOLING DATA WITH OTHER DATA
SETS SO THEY'RE USING IT AS A
COMPARATIVE TO AUTISM, TURRETS,
POOLING ABCD DATA WITH OTHER
DATA SETS AND WE ARE SEEING
STUDIES THAT ARE TAKING ABCD
TASKS AND DEVELOPING ANIMAL
MODELS TO BE ABLE TO START
LOOKING AT MECHANISMS WHICH IS
ONE OF THE LONG-TERM GOALS THAT
WE WANTED TO SEE WITH ABCD AS
WELL.
AND AS A RESULT OF ALL OF THESE
GRANTS THAT HAVE BEEN FUNDED
WE'VE ALSO SEEN A DRAMATIC
INCREASE IN THE NUMBER OF
PUBLICATIONS THAT HAVE COME OUT
USING ABCD DATA SO OVER 550
PAPERS HAVE COME OUT WHICH IS
REALLY EXCITING TO SEE AND I
EXPECT THIS IS EARLY IN 2023.
I EXPECT THIS SLOPE TO GO MUCH
HIGHER AS WE GET CLOSER TO THE
END OF THE YEAR. SO I'D NOW
LIKE TO HAND IT OFF TO KIM
LEBLANC TO IDENTIFY A COUPLE OF
PAPERS THAT EXEMPLIFIES THE WORK
THAT WE'RE SEEING COME OUT OF
ABCD.
>>THANK YOU, EVERYONE, FOR
BEING HERE. I'M GOING TO
PRESENT TWO PAPERS THAT HAVE
RECENTLY COME OUT.
ACTUALLY THE SENIOR AUTHOR ON
ONE OF THESE PAPERS SO I'LL
MENTION WE'RE ONLY GOING TO BE
TOUCHING ON THE PORTION OF THE
PAPER SO I HOPE YOU'LL READ IT
WHEN YOU HAVE A CHANCE.
THIS IS WHAT THEY EXPECT ALCOHOL
MIGHT DO OR THE SORT OF EFFECTS
IT MIGHT HAVE, WHETHER OR NOT
THEY HAVE PERSONAL EXPERIENCE
CONSUMING IT BEFORE.
AN EXAMPLE OF A POSITIVE ALCOHOL
EXPECTANCY, IS ALCOHOL HELPS A
PERSON TO RELAX.
NEGATIVE, ALCOHOL CAN AFFECT HOW
A PERSON GETS ALONG WITH OTHERS.
WE ALSO MEASURE ALCOHOL SIPPING
AND OTHER CASES FOUND THAT
ALCOHOL SIPPING BY THE AGE OF
10.
SO ALCOHOL SIPPING MAY A
PREDICTOR IN FUTURE ALCOHOL USE
IN ADVERSE OUTCOMES.
TRAUMATIC EVENTS THAT OCCUR
BEFORE THE AGE OF 18 AND INCLUDE
ABUSE, NEGLECT AND HOUSEHOLD
DYSFUNCTION AND AFFECTS A
SIGNIFICANT PERCENT OF THE
POPULATION. ACE HAS BEEN LINKED
TO A NUMBER OF DOWNSTREAM
BEHAVIORAL, PHYSICAL AND MENTAL
HEALTH CONDITIONS INCLUDING
ALCOHOL YOU DISORDER AND WHILE
THIS LINK TO AUD HAS BEEN WELL
ESTABLISHED THE LINK IS MUCH
MORE EARLIER ONSET HAS NOT BEEN
NEARLY AS WELL STUDIED.
SO THEY'RE HELPING TO ADDRESS
THAT.
THEY USED BASELINE ABCD STUDY
DATA.
IN THE PAPER IT WAS ALCOHOL
NAIVE CHILDREN SO THEY HAD NEVER
TRIED IT BEFORE.
SOCIO DEMOGRAPHIC FACTORS ON
THEIR POSITIVE AND NEGATIVE
ALCOHOL EXPECTANCIES AND THE
PAPER LOOKED AT PARTICIPANTS WHO
HAD DONE SOME AMOUNT OF ALCOHOL
SIPPING AND EXAMINED THE
RELATIONSHIP BETWEEN THE AS AND
SIPPING BEHAVIOR AND THIS IS
SHOWING THE PREVALENCE OF
ALCOHOL SIPPING.
SO 23% HAD ALREADY DONE SOME
SIPPING.
THIS IS THE ADDITIONAL
PREVALENCE IN THE ABCD STUDIES
AND YOU CAN SEE THERE'S ACTUALLY
FAIRLY SIGNIFICANT PORTIONS THAT
HAVE EXPERIENCED SOME AMOUNT OF
HOUSEHOLD VIOLENCE, SUBSTANCE
ABUSE, MENTAL ILLNESS AND
OTHERS.
AND WHILE THE TWO STUDIES LOOKED
AT SLIGHTLY DIFFERENT BEHAVIORS
AND ATTITUDES, THEY BOTH FOUND
THAT HAVING MORE AS WAS
ASSOCIATED WITH AN INCREASED
RISK OF THOSE BEHAVIORS SO A
LARGER NUMBER OF AS WERE
ASSOCIATED WITH A GREATER
LIKELIHOOD OF ALCOHOLIC
EXPECTANCIES.
SO THAT'S REALLY YOU SEE ON THE
RIGHT.
ADVERSE CHILDHOOD EXPERIENCES
THE SUM OF THEM IS GOING ON THE
X AXIS AND THE PROBABILITY OF
THEIR SIPPING ALCOHOL ON THE Y.
YOU CAN SEE THE NEARLY LINEAR
RELATIONSHIP THERE.
THEY ALSO LOOKED AT SUBTYPES IN
THE HOUSEHOLD VIOLENCE AND
HOUSEHOLD ALCOHOL ABUSE WERE
SIGNIFICANT PREDICTORS.
SO AS PLAY A SIGNIFICANT ROLE IN
EARLY ALCOHOL BEHAVIORS.
THEY FOUND THAT AS WERE
ASSOCIATED WITH POSITIVE ALCOHOL
EXPECTANCIES AND THE
ACCUMULATING WERE GREATER WITH
THE ALCOHOL SIPPING IN THOSE WHO
HAD DONE AN AMOUNT OF SIPPING.
WE'LL BE ABLE TO INVESTIGATE
THEIR FUTURE ALCOHOL DRINKING IN
THESE PARTICIPANTS TO SEE IF IT
DOES DEVELOP INTO MORE SERIOUS
DRINKING HABITS AND ALSO
HIGHLIGHTS THAT AS ALONG WITH
OTHER SOCIO DEMOGRAPHIC
ENVIRONMENTAL VARIABLES FOR
EARLY PREVENTION AND
INTERVENTION STRATEGIES.
>>I'M NOW GOING TO TURN IT OVER
TO TRACI MURRAY TO GIVE AN
UPDATE ON JEDI.
ARE YOU THERE?
>>I AM.
CAN YOU HEAR ME.
>>YES.
>>AWESOME.
SO I'D LIKE TO TAKE THIS
OPPORTUNITY TO HIGHLIGHT A
NUMBER OF ACTIVITIES IN EQUITY,
DIVERSITY AND INCLUSION AND SO
FIRST THERE'S A LOT OF WORK TO
BE DONE AND MRORS OF OUR MEMBERS
WORK IN ABCD AS A PURSUIT OF
THEIR EFFORT.
AS A RESULT, DEDICATED FTES --
THIS ENSURES JEDI PRIORITIES
HAVE THE SAME LEVEL OF AUTHORITY
AND OVERSIGHT AS OTHER KEY STUDY
COMPONENTS WITH ASSOCIATE
DIRECTORS.
THE DIRECTORS ALSO GIVE
ADMINISTRATIVE SUPPORT TO MANAGE
A SIGNIFICANT NUMBER OF TASKS.
MY ROLE IS QUITE UNIQUE.
I DIRECTLY SUPPORT ABCD STUDIES
BY PARTICIPATING IN ALL JEDI
WORK.
I SHARE IDEAS AND LESSONS
LEARNED AND THIS ALLOWS US TO
BRING THOSE RESOURCES INTO THE
STUDY AND ALSO USE INFORMATION
FROM THE STUDIES TO PERFORM DEI
WORK ACROSS THE AGENCY.
LAST YEAR ABCD BROUGHT IN AN
EXTERNAL CONSULTANT TO ASSESS
THE JEDI CULTURE WITHIN OUR
STUDY.
IT INCLUDED A ROAD
AND RECOMMENDATIONS THAT ARE
GUIDING OUR EFFORTS TO
CONTINUOUSLY IMPROVE JEDI AND
SOME OF THOSE ARE LISTED HERE ON
THE SLIDE.
NEXT SLIDE? THE CONSULTANTS
REPORT HELPED US TAKE A MOMENT
TO REFLECT ON JEDI ACTIVITIES IN
THE STUDY.
IT HAS BEEN A PART OF ABCD SINCE
ITS INCEPTION, THE MURDER OF
GEORGE FLOYD FURTHER HIGHLIGHTED
THE NEED TO ADDRESS RACIAL
DISCRIMINATION IN ALL SYSTEMS
INCLUDING SCIENCE. WE WANT TO
BUILD ON THAT MOMENTUM AND
ADDRESS ALL TYPES OF
DISCRIMINATION. WITHIN ABCD,
JEDI IS LED BY THREE WORK
GROUPS.
THE EQUITABLE AND INCLUSIVE
METHODS REVIEWS ALL AREAS AND
PROTOCOLS FOR POTENTIAL BIAS AND
DEVELOPING MORE INCLUSIVE
MEASURES.
THE DIVERSITY AND INCLUSION LED
A DEMOGRAPHIC SURVEY TO
UNDERSTAND THE MAKEUP OF OUR
MEMBERS, AFFINITY GROUPS TO
SUPPORT UNDERREPRESENTED GROUPS
AND BUILD COMMUNITY AND
BELONGING WITHIN ABCD. OUR
RESPONSIBLE USE OF DATA WORK
GROUP LOOKED AT HOW THE USE OF
ABCD WORK, ELIZABETH'S
PRESENTATION ON DIFFERENCES IN
BRAIN STRUCTURE IS AN EXAMPLE OF
THE IMPORTANCE OF SUCH WORK.
WE ALSO RESTRUCK CTURED JEDI WO.
AND WE'RE INTEGRATING JEDI INTO
MORE SPACES BY CREATING A JEDI
ALL HANDS TO PROVIDE UPDATES AND
TRAINING TO THE ENTIRE
CONSORTIUM.
FOR OUR FIRST ALL HANDS OVER 80
MEMBERS ACROSS ALL LEVELS JOINED
US TO LEARN ABOUT CURRENT AND
PROPOSED CHANGES TO THE FEDERAL
RACE AND ETHNICITY CATEGORIES ON
THE CENSUS INCLUDING THE HISTORY
OF THOSE CATEGORIES.
NEXT SLIDE.
THANK YOU.
IN CLOSING I'D LIKE TO HIGHLIGHT
THE SCIENTIFIC TRAINING IN
ADDICTION RESEARCH TECHNIQUES OR
START PROGRAM.
START IS DEDICATED TO ENHANCING
DEI IN THE SUBSTANCE MISUSE
RESEARCH WORK FORCE THROUGH A
MENTORED APPROACH WHERE SCHOLARS
AT THE PREDOT, POST DOT AND
FACULTY LEVEL.
IF YOU'RE ATTENDING AN UPCOMING
CONFERENCE PLEASE JOIN THEIR
SESSION.
THANK YOU.
>>THANK YOU, TRACI.
ELIZABETH, ARE YOU THERE?
>>CAN YOU ALL HEAR ME?
>>A LITTLE BIT LOUDER.
>>OKAY.
IS THAT BETTER?
>>YEP.
THANK YOU.
>>SUPER.
GOOD AFTERNOON, EVERYONE.
I'M SORRY I CAN'T BE THERE IN
PERSON.
I'M GOING TO TELL YOU ABOUT A
VERY RECENT PAPER LOOKING AT
RACIAL DISPARITIES AND ADVERSITY
DURING CHILDHOOD AND ALSO RACE
RELATED DIFFERENCES IN BRAIN
STRUCTURE.
THIS PAPER, MANY OF YOU KNOW
HAVE GOTTEN A LOT OF PRESS JUST
IN THE LAST COUPLE OF MONTHS
SINCE FS PUBLISHED AND IT REALLY
DISSPELLS NOTIONS OF INHERENT
DIFFERENCES.
SO THIS IS A SUPER IMPORTANT
CONTRIBUTION TO THE FIELD
BECAUSE AS WE -- MANY OF US
KNOW, PAST RESEARCH HAS REALLY
FOCUSED ON RACE DIFFERENCES,
EVEN BDOING ANALYSIS TO WHAT'S
BEHIND RACE AND WE KNOW RACE IS
A SOCIAL CONSTRUCT WITH
ENVIRONMENT TALL FACTORS
EMBEDDED WITHIN.
AND SO IT'S ABSOLUTELY
IMPERATIVE THAT WE LOOK AT THOSE
FACTORS CRITICALLY.
AND SO THIS PAPER DOES JUST
THAT.
NEXT SLIDE, PLEASE.
SO WE KNOW THAT BLACK YOUTH IN
THE U.S. ARE DISPROPORTIONATELY
BURDENED WITH ADVERSITY,
INCLUDING MATERIAL HARDSHIP AND
TRAUMA AND THIS TABLE TO THE
RIGHT IS FROM A FEW YEARS AGO
HIGHLIGHTING THIS DISPORTIONAL
BURDEN.
WE ALSO KNOW THAT EARLY
ADVERSITY IS ASSOCIATED WITH
STRUCTURAL BRAIN REGIONS.
THE CORTEX AND THE HIPPOCAMPUS
AND PREVIOUS WORK HAS SHOWN
LARGER NEURAL RESPONSES WITHIN
THESE SAME REGIONS IN BLACK
COMPARED TO WHITE YOUNG ADULTS
AND THESE WERE PARTIALLY
ATTRIBUTABLE TO DISPARITIES AND
NEGATIVE LIFE EXPENRIENCE.
THIS PAPER GOES A STEP FURTHER
TO INVESTIGATE THE RELATIONSHIP
BETWEEN RACIAL DISPARITIES AND
ADVERSITY AND THE STRUCTURE OF
THE WHOLE DURING CHILDHOOD TO
UNDERSTAND HOW CONTEXTUAL
FACTORS MAY ALSO IMPACT THIS
NEUROCIRCUITRY.
NEXT SLIDE, PLEASE.
SO THE OVERALL AIM WAS TO LOOK
AT THIS RELATIONSHIP WITH
DISPARITIES AND ADVERSITY
EXPOSURE AND THIS WAS USING DATA
FROM THE BASELINE VISIT IN ABCD,
SO THE AGES WERE ABOUT 9 AND 10.
WE LOOKED IN EXPOSURE TO
ADVERSITY AS A FIRST LOOK AT THE
DATA.
IT THEN RAN MODELS TO ASSESS
RACE RELATED DIFFERENCES IN GRAY
MATTERED VOLUME.
SO THERE WERE 14 BRAIN REGIONS
THAT WERE DEFINED EACH OF WHICH
IS ITS OWN DEPENDENT VARIABLE IN
EACH OF THESE MODELS AND THEN
WHETHER ACCOUNTING FOR CHILDHOOD
ADVERSITY WOULD ATTENUATE THESE
RACE RELATED DIFFERENCES IN
REGIONAL BRAIN MATTER VOLUME SO
THIS IS THE CRUX OF THE PAPER
AND THEY DID THIS BY CONDUCTING
PARALLEL MEDIATION MODELS.
NEXT SLIDE, PLEASE.
SO THE FIRST THING TO NOTE IS
THAT THEY SHOWED
DISPROPORTIONATE ADVERSITY
EXPOSURE IN BLACK YOUTH.
THIS IS SHOWN IN THIS TABLE.
THIS IS CONSISTENT ACROSS ALL
THE ADVERSITY METRICS.
CARE GIVERS OF BLACK YOUTH ALSO
HAD LOWER EDUCATIONAL
ATTAINMENT, LOWER INCOME AND
EMPLOYMENT COMPARED WITH THOSE
OF WHITE YOUTH.
BLACK YOUTH ALSO HAD LOWER BRAIN
USE, BUT CRITICALLY THE BRAIN
VOLUME DIFFERENCES VARIED WITH
ADVERSITY METRICS WITH INCOME
BEING THE MOST FREQUENT
PREDICTOR AND DISPARITIES
PARTIALLY MEDIATED SOME OF THESE
DIFFERENCES. SO ACCOUNTING FOR
DIFFERENCES IN EXPOSURE TO
ADVERSITY PARTIALLY MEDIATED THE
RACE RELATED DIFFERENCE AND THIS
IS A GRAPHIC THAT SHOWS REGIONS
WITHIN THE FRONTAL LOBE THAT HAD
THIS PARTIAL MEDIATION EFFECT.
THERE ARE ALSO REGIONS HERE THAT
DID NOT HAVE A MEDIATION EFFECT
AND SO THIS KIND OF RAISES THE
QUESTION ABOUT FOR EXAMPLE, WHY
THE AMYGDALA AND THE HIPPOCAMPUS
WHICH ARE ALSO THESE EMOTIONAL
AREAS, WHY THIS DID NOT SURVIVE
THE PARTIAL MEDIATION ANALYSIS
AND I PUT DOWN HERE IN THIS BOX
ADDITIONAL SOCIO DEMOGRAPHIC
VARIABLES THAT ARE AVAILABLE IN
ABCD BUT NOT INCLUDED IN THESE
ANALYSIS.
PERCEIVED DISCRIMINATION, SCHOOL
CONTEXTUAL MATTERS AND CENSUS
BASED MEASURES OF SYSTEMIC
INEQUITIES. SO THE PAPER I JUST
WANTED TO HIGHLIGHT SOME OF THE
PRESS AND THE COMMENTARIES THAT
HAVE FOLLOWED THE PUBLICATION OF
THIS PAPER, MOST NOTELY A
COMMENTARY WHO NOTES THAT THE
FINDINGS BEGIN TO CORRECT THE
LONG HISTORY OF REPORTING OF
DIFFERENCES IN HEALTH,
BEHAVIORAL AND NEURAL OUTCOMES
AATTRIBUTED TO RACE AND/OR
ETHNICITY.
YOU CAN SEE HERE A FEW OF MANY,
MANY NEWS ACCOUNTS OF THESE
FINDINGS AND EACH OF THEM REALLY
HIGHLIGHTS THIS NUANCED FINDING.
SO YOU'LL NOTE THAT NONE OF THEM
FOCUS ON BLACK VERSUS WHITE.
AND THEN SOME QUESTIONS AND
CHALLENGES THAT HAVE EMERGED AND
ONE THING THAT IS WONDERFUL
ABOUT A PAPER LIKE THIS, IT'S A
REALLY NICE EXAMPLE OF HOW ABC
DATA SHOULD BE USED, SHOULD BE
INTERPRETED, EDITORIZED AND THEN
REPORTED ON BY THE PRESS. I
HOPE IT'S SOMETHING THAT
CONTINUES IN THE FUTURE.
I THINK IT'S A GREAT EXAMPLE OF
HOW WE CAN HAVE RICH AND ROBUST
DISCUSSION ABOUT REALLY
DIFFICULT QUESTIONS AND
CHALLENGES, SOME OF WHICH ARE
NOTED HERE.
FOR EXAMPLE, IMPORTANTLY WHAT
HAPPENS AT COST DEVELOPMENT.
THIS DATA FROM BASELINE.
HOW MIGHT THEY CHANGE ACROSS
DEVELOPMENT WITH ADDITIONAL
ENVIRONMENT TALL CONTRIBUTIONS,
RACIAL DISPARITY AS I POINTED
OUT AND ADVERSITY ONLY PARTIALLY
IN GRAY MATTER VOLUME BUT IT
EXCLUDED OTHER CONSTRUCTS.
THIS IS NOT ANY KIND OF
INTENTIONAL EXCLUSION.
IT'S JUST THE KIND OF DATA
ANALYSIS THAT THEY CONDUCTED BUT
IT DOES LEAVE THE READER WITH
THE POTENTIAL IMPRESSION THAT
RACE CONTINUES TO ACCOUNT FOR
BRAIN VOLUME EVEN AFTER
CONSIDERING SOCIAL FACTORS.
AND THE REALLY I THINK ROBUST
DISCUSSION TOPIC THAT WE CAN
MAYBE TURN TO DURING THE
DISCUSSION SECTION TODAY IS
SHOULD WE AVOID FRAMING THIS
KIND OF WORK IN THE CONTEXT OF
RACE DIFFERENCES IN BRAIN OR
BEHAVIOR ALTOGETHER AND INSTEAD
FOCUS DIRECTLY ON SOCIAL
DETERMINANTS OF HEALTH AND MANY
OTHERS FACE MORE SOCIAL
DETERMINANTS OF HEALTH.
I WILL STOP THERE AND LOOK FOR
WARD TO DISCUSSION LATER.
>>THANK YOU.
SOME VERY PROVOCATIVE QUESTIONS
THAT WE MIGHT BE ABLE TO ADDRESS
IN THE DISCUSSION SESSION. I'D
LIKE TO CONCLUDE BY TALKING A
LITTLE BIT ABOUT RESEARCH
DISSEMINATION.
THESE ARE WHAT WE HOPED IN TERMS
OF RESEARCH THAT PEOPLE WOULD DO
WITH THE DATA SET AND THAT IT
WOULD SPUR OTHER RESEARCH IN THE
OTHER AREAS.
AND I WANT TO HIGHLIGHT A PAPER
THAT RECENTLY CAME OUT JUST LAST
WEEK THAT REALLY, THAT NORA
MENTIONED YESTERDAY IN HER
COUNCIL PRESENTATION, BUT IT
REALLY SPEAKS TO BEING ABLE TO
INFORM POLICY AND PRACTICE WHICH
WAS ON THAT LAST SLIDE AND YOU
KNOW, I DON'T HAVE A LOT OF TIME
TO GO INTO THE STUDY, BUT WHAT
IT DID WAS LOOK AT BOTH
HIPPOCAMPAL VOLUME AND
INTERNALIZING SYMPTOMS AMONG
YOUTH THAT WERE GROWING UP IN
HIGH COST OF LIVING OR LOW COST
OF LIVING STATES AND THE
DISPARITY BETWEEN LOW INCOME AND
HIGH INCOME YOUTH AND
ESSENTIALLY WHAT THEY FOUND WAS
THAT IN HIGH COST OF LIVING
STATES THAT HAD HIGH CASH
BENEFITS, THE DISPARITY BETWEEN
LOW INCOME AND HIGH INCOME YOUTH
BOTH IN INTERNALIZING SYMPTOMS
AND THE HIPPOCAMPAL VOLUME WAS
REDUCED.
THIS HAS RECEIVED QUITE A BIT OF
ATTENTION AND THIS IS A NICE
PARTNERSHIP BETWEEN THE SCIENCE
AND OUR PRESS TEAM WHO PUT OUT A
PRESS RELEASE WHEN THIS CAME OUT
AND IN JUST LESS THAN A WEEK
THERE WERE OVER 330 NEWS STORIES
HIGHLIGHTING THIS IMPORTANT
FINDING OF SOMETHING THAT IS
CLEARLY ACTIONABLE THAT CAN BE
DONE TO REDUCE SOME OF THESE
DISPARITIES
>>IN ADDITION TO THAT I
MENTIONED AT THE BEGINNING THAT
ABCD HAS BEEN DOING A LOT TO
ENGAGE OUR FAMILIES BETTER AND
REALLY TO SHOW THEM WHAT THEIR
CONTRIBUTIONS HAVE MADE TO
SCIENCE.
AND IN THAT RESPECT, WE LED BY
ELIZABETH HOFFMAN WE DEVELOPED
AN INTO GRAPHIC REALLY TO
HIGHLIGHT SOME OF FINDINGS FROM
ABCD IN LANGUAGE THAT EVERYBODY
CAN UNDERSTAND AND WE STARTED
WITH SCREEN TIME BECAUSE THAT'S
PROBABLY THE QUESTION WE GET
ASKED MOST IS WHAT IS THE STUDY
SHOWING ABOUT SCREEN TIME.
OUR FAMILIES ARE VERY MUCH
INTERESTED IN THIS.
SO OUR COMMUNICATIONS ENGAGEMENT
AND DISSEMINATION TEAM PUT
TOGETHER -- AND OUR RETENTION
WORK GROUP ACTUALLY WENT THROUGH
THE FINDINGS THAT ARE RELATED TO
SCREEN TIME, DISTILLED THEM INTO
MESSAGES THAT COULD BE EASILY
COMMUNICATED IN AN INFO GRAPHIC.
IT WAS DISSEMINATED TO OUR
FAMILIES AND ADVISORY GROUPS AND
IT'S GOTTEN PICKUP WITH OTHER
ORGANIZATIONS. MORE RECENTLY,
WE TRANSLATED THIS INFO GRAPHIC
INTO A WEBINAR FOR FAMILIES
WHERE WE INVITED SOME OF THE
RESEARCHERS WHOSE WORK WAS
HIGHLIGHTED IN THE INFO GRAPHIC
AND THIS WEBINAR WAS DESIGNED
FOR OUR FAMILIES SO THEY COULD
COME AND HEAR THE SPEAKERS TALK
ABOUT THEIR FINDINGS, BUT MORE
IMPORTANTLY WE SET ASIDE 45
MINUTES FOR THEM TO ASK
QUESTIONS OF THE SPEAKERS AS A
REAL OPPORTUNITY NOT ONLY TO SEE
WHAT WAS COMING OUT OF THEIR
PARTICIPATION IN THE STUDY BUT
ALSO TO GET THEIR OWN QUESTIONS
ANSWERED ABOUT WHAT IS OF
INTEREST DO THEM.
AND THIS ALL HAPPENED LAST
THURSDAY.
SO IT'S KIND OF HOT OFF THE
PRESSES.
AND WE HAD ABOUT 250 NONFEDERAL
EMPLOYEES OR WEBINAR STAFF
PARTICIPATE IN THIS FIRST
WEBINAR AND NEARLY
(INDISCERNIBLE) OF THOSE WERE --
IDENTIFIED THEMSELVES AS PARENTS
OR CARE GIVERS OF ABCD USE.
I'M GUESSING PEOPLE IN THE OTHER
CATEGORY ARE ALSO PARTICIPANTS
BUT THIS IS WHAT WE WANTED TO
SEE.
WE WANT TO GIVE BACK TO OUR
FAMILIES THE INFORMATION THAT WE
ARE LEARNING FROM ALL OF THE --
ALL THAT THEY CONTRIBUTE TO THE
STUDY.
SO THIS WAS OUR FIRST FORAY INTO
THIS.
WE'VE GOT OTHER INFO GRAPHICS
PLANNED.
ONE ON SLEEP, ONE ON COVID AND
WE PLAN TO DO THESE WEBINARS AND
I'LL SPEAK FOR ELIZABETH WHERE
THIS IS ONE OF THE HIGHLIGHTS
CERTAINLY OF THE WORK THAT WE'VE
DONE IN THE LAST COUPLE OF WEEKS
SO WE'RE REALLY EXCITED ABOUT
THAT.
SO WITH THAT I'D JUST LIKE TO
THANK EVERYBODY.
THANK ALL OF THE PARTNERS.
THIS IS A HUGE COLLABORATION
ACROSS NIH AND OTHER FEDERAL
STAFF.
THANK THE RESEARCHERS AT THE
SITES, THE DATA CENTER, HUNDREDS
OF INVESTIGATORS AND TRAINEES
BUT MORE IMPORTANTLY ID I'D LIKE
TO THANK ALL OF THE RESEARCH
ASSISTANTS AND STAFF AND ALSO
GETTING EVERYBODY BACK ON TRACK
AS WE ARE EMERGING FROM THE
PANDEMIC AND THEN TO THE NEARLY
12,000 PARTICIPANTS AND FAMILIES
WHO HAVE GIVEN US SO MUCH OVER
THE YEARS AND CONTINUE TO BE
REALLY DEDICATED TO THE STUDY
MOVING FORWARD.
SO THANK YOU.
>>I BASICALLY REALIZED THAT WE
ARE RUNNING LATE BUT I DON'T
WANT TO CUT OFF THE OPPORTUNITY
TO HAVE SOME QUESTIONS.
IS THAT OKAY, MICHELLE?
>>[ AWAY FROM MICROPHONE ].
>>NO, BUT I THINK THAT THIS IS
SUCH A SPECTACULAR PROGRESS AND
IT COVERS SO MANY ISSUES THAT I
DON'T WANT TO -- SO PLEASE, IF
YOU HAVE QUESTIONS, ASK GAYATHRI
AND SHE CAN HELP ADDRESS.
>>THAT WAS JUST AMAZING FOR YOU
AND ALL THE TEAM.
IT REALLY I THINK HIGHLIGHTS
THE -- SOMETHING THAT WE'VE BEEN
IGNORING WHICH HAS BEEN THE
SOCIAL DETERMINANTS BUT IMBEDDED
IS THE TRAUMA PIECE AND ALL THE
THINGS THAT REALLY STRETCH OUR
FAMILIES.
YOU KNOW, AND SO THE -- I GUESS
THE ONE THING THAT IS REALLY
JARRING AND COMING AT IT, WE'VE
KNOWN SOME OF THESE THINGS AND
LOOKING AT IT IN TERMS OF THE
ABCD STUDY IS REALLY IMPORTANT
IN DRIVING HOME THE POINT THAT
WE'RE JUST NOT SET UP TO START
THINKING ABOUT PREVENTION OR
ADDRESSING THIS.
AND THERE FINDS TO BE A
FRAMEWORK BASED ON THESE DATA
AND THESE ARE NOT COMPLETELY
NEW.
THEY'RE NOT SURPRISING.
SO I THINK THAT IS ONE BIG, BIG
THING THAT IS JUST, YOU KNOW,
JUMPING OUT AT ME, BUT THE OTHER
PIECE I THINK THAT I WOULD LIKE
TO ASK A QUESTION ABOUT AND I
KNOW WE'VE TALKED ABOUT THIS
OVER THE YEARS ABOUT HOW TRAUMA
IS BEING ASSESSED AND HOW
TREATMENT IS BEING ASSESSED AND
THERE WERE SOME ISSUES EARLY ON
ABOUT HOW MUCH ASSESSMENT TO DO
AND SO I'VE COME BACK TO THAT
BECAUSE YOU'RE SEE THG AS A VERY
IMPORTANT KEY FINDING OR KEY
RISK FACTOR, AND SO COULD YOU
SPEAK A LITTLE BIT TO WHETHER
THOSE ASSESSMENTS HAVE
BROADENED, WHETHER YOU'RE SEEING
THE ABILITY TO LOOK AT
MALTREATMENT OR EVEN EMOTIONAL
DISREGULATION IN MULTIPLE WAYS
AS THE CHILDREN ARE GROWING
EARLIER AND, YOU KNOW, AROUND
THAT ISSUE.
>>CERTAINLY.
YEAH.
YOU KNOW, ONE OF THE THINGS I
THINK WE TALKED ABOUT A FEW
YEARS AGO WHEN WE WERE
DISCUSSING THAT WERE THAT THE
YOUTH WERE SO YOUNG THAT WE WERE
GETTING A LOT OF THE INFORMATION
FROM THE CARE GIVERS AND THAT
MIGHT NOT BE THE BEST TO GET AT
SOME OF THIS INFORMATION.
SO NOW THAT THE YOUTH HAVE
GOTTEN OLDER WE ARE ASKING THEM
MORE QUESTIONING DIRECTLY WHERE
WE ARE ASKING THEM -- YOU KNOW,
THE PTSD MODULE TO GET AT LEAST
SOME OF THE REPORTING DIRECTLY
FROM THE YOUTH.
BUT YOU'RE RIGHT.
IT'S A COMPLICATED AREA THAT --
FOR US TO BE ABLE TO COLLECT
THAT INFORMATION, BUT THAT'S
BEEN MORE HOW WE'VE EXPANDED IT.
I DON'T KNOW, KIM, IF YOU KNOW
THERE ARE OTHER AREAS IN THE
MENTAL HEALTH SPACE THAT WE'VE
ADDED IN THAT RESPECT?
>>I JUST WANT TO FOLLOW UP
BECAUSE WE ARE SO PROGRAMMED TO
THINK ABOUT ILLNESS, PTSD.
BUT TRAUMA IS NOT ONLY RISK
FACTOR FOR PTSD AND IN FACT
IT'S -- FOR CRAN IT'S A RISK
FACTOR FOR CANCER, PHYSICAL, ALL
OUR HEALTH BEHAVIORS,
ALCOHOLISM, AND SO I THINK THE
ABILITY TO REALLY SORT OF CALL
TRAUMA IN DIFFERENT WAYS AS WELL
AS --
>>SO THE MODEL DOES ASK ABOUT
SPECIFIC EVENTS.
WE ALSO HAVE A MEASURE THAT IS
CALLED LIFE EVENTS AND WE'RE NOW
ASKING THE YOUTHS ABOUT THESE
EVENTS IN THEIR LIVES RATHER
THAN GETTING THE INFORMATION
JUST FROM THE PARENTS.
>>I THINK IT COMES BACK TO YOUR
ISSUE OF RACE AND WHETHER RACE
SHOULD BE PULLED OUT BECAUSE
ACTUALLY THERE'S A LOT THAT RACE
IS JUST REALLY A PROXY FOR --
>>RIGHT.
AND ONE THING I DIDN'T MENTION
THAT WE HAVE BEEN DOING MORE OF
IN THE LAST COUPLE OF DATA
RELEASES IS BRINGING DATA IN
FROM EXTERNAL DATA SETS THAT
SPEAK TO THINGS THAT ARE THERE
THE ENVIRONMENT THAT MAY BE
CONTEXTUALIZING, SO EXPOSURE TO
POLLUTIONS, EXPOSURE TO CRIME,
EXPOSURE TO A LOT OF DIFFERENT
AREAS THAT ARE IN THE
ENVIRONMENT THAT REALLY -- THAT
CAN ENHANCE THE DATA SET WITHOUT
ADDING BURDEN TO THE
PARTICIPANTS BUT REALLY SPEAK TO
SOME OF THOSE MOD FINAL FACTORS
BECAUSE AGAIN, THAT'S REALLY
WHERE WE WANT TO BE IS IDENTIFY
THOSE FACTORS THAT WE CAN
CHANGE, YOU FLOW, IF WE'RE NOT
ABLE TO ELIMINATE POVERTY, WHAT
CAN WE DO TO RELIEVE SOME OF
THOSE BURDENS TO IMPROVE THE
LIVES OF (INDISCERNIBLE).
>>THAT WAS JUST A GREAT
PRESENTATION. THANK YOU SO
MUCH.
JUST QUICKLY, I'M SURE YOU'RE
DOING THIS, BUT I'M INTERESTED
TO KNOW ABOUT WHAT YOU ARE
LEARNING ABOUT GENDER
DIFFERENCES.
THIS IS AN INCREDIBLY IMPORTANT
OPPORTUNITY FOR US TO UNDERSTAND
A RANGE OF FACTORS BIOLOGICAL
AND SOCIO DEMOGRAPHICS, SDOH
FACTORS.
WE HAVE HAD SO MUCH CURIOSITY
ABOUT ALL OF THESE THINGS IN
TERMS OF NEURODEVELOPMENT AND
ALSO THE EXPRESSION OF MENTAL
HEALTH AND SUBSTANCE USE
DISORDERS IN GIRLS AND BOYS AND
THIS IS LIKE SUCH A UNBELIEVABLE
OPPORTUNITY, SO I'M CURIOUS IF
YOU'RE ALREADY SEEING OR
EXPLORING WHAT SOME OF THOSE
LOOK LIKE AND I'M HOPING YOU'RE
DOING A LOT OF THINGS AROUND
MENSTRUAL CYCLE AND OTHER THINGS
IN THIS STUDY JUST BECAUSE WE
DON'T KNOW A LOT ABOUT THAT AS
WELL.
>>YEAH.
SO WE OF COURSE AGGREGATE THE
DATA BY SEX SO WE HAVE A NUMBER
OF PAPERS AND I'M HAPPY TO GIVE
YOU KIND OF A SUMMARY OF THAT.
THERE ARE TOO MANY TO KIND OF GO
INTO NOW BUT THERE ARE A NUMBER
OF AREAS THAT PEOPLE ARE LOOKING
AT SEX DIFFERENCES.
WE DO COLLECT INFORMATION
ABOUT -- WE HAVE A WORK SGRUP
THAT'S FOCUSED ON GENDER DIETTY
AND SEXUAL HEALTH WHICH HAS BEEN
INCREASING THE NUMBER OF
QUESTIONS SO WE'RE ALSO GETTING
AT ISSUES SUCH AS CONTRACEPTIVE
USE AND OTHER THINGS THAT ARE
CONTRIBUTING TO OUTCOMES. SO
THAT IS DEFINITELY A FOCUS FOR
US AND I'M HAPPY TO FOLLOW UP
WITH YOU ABOUT SPECIFIC AREAS
THAT WE HAVE SOME PAPERS THAT
ARE DOING THAT.
>>SURE.
>>THANK YOU SO MUCH.
THIS IS GREAT.
AS A PEDIATRICIAN, THIS IS VERY
IMPACTFUL AND SOME DATA THAT WE
CAN ACTUALLY USE IN PRACTICE.
AS A FORMER POLICY PERSON, I
HAVE A RECOMMENDATION IF YOU
HAVEN'T ALREADY DONE THIS.
THE CENTER FOR MEDICAID AND CHIP
SERVICES, THE NATIONAL MEDICAID
PROGRAM, I BELIEVE DOES NOT HAVE
A -- I THINK THEY ONLY HAVE TWO
CLINICIANS WORKING WITHIN THE
ENTIRE PROGRAM.
THEY DON'T HAVE A LOT OF BAND
WIDTH COMPARE LITERATURE.
THERE'S A NETWORK OF STATE
MEDICAID MEDICAL DIRECTORS,
ACADEMY HEALTH ORGANIZES THAT,
I'M HAPPY TO CONNECT YOU WITH
THEM.
AND I THINK AT THE POLICY LEVEL
THE STATE MEDICAID DIRECTOR
LEVEL, THEIR ANNUAL CONFERENCE
IN THE FALL TO HAVE YOU KEYNOTE
WITH THESE DATA WOULD BE
TREMENDOUS.
THEY DO NOT KNOW THESE DATA.
THEY ARE NOT UP TO DATE.
KIDS ARE IGNORED UNFORTUNATELY
AND MEDICAID AND CHIP COVERS
HALF THE KIDS IN THE COUNTRY SO
THIS WOULD BE VERY POLICY
RELEVANT.
THE QUESTION I HAVE FOR YOU IS
AS AN INVESTOR, ARE THESE DATA
AVAILABLE TO NONRESEARCHERS SO
THAT IT CAN INFORM MARKET
ANALYSIS OR PRUK OR SERVICE
DEVELOPMENT NOT JUST FOR
APPLYING FOR RESEARCH FUNDING
BUT TO FORM INNOVATIVE CARE
MODEL DESIGN?
>>ELIZABETH, DO YOU WANT TO
ANSWER THAT QUESTION?
>>SO LET'S SEE.
YES, SO THE DATA ARE REALLY
AVAILABLE TO ANYONE WHO HAS
AUTHORIZED USE OF THE DATA, SO
THEY HAVE -- THEY'RE AFFILIATED
WITH AN INSTITUTION THAT IS
RECOGNIZED BY NIH AS AN
AUTHORIZED -- YOU KNOW, WITH
FEDERAL ASSURANCE THAT THEY CAN
ACCESS THE DATA.
THERE REALLY ARE NO OTHER
RESTRICTIONS OTHER THAN THAT.
>>IF OFFLINE YOU MIGHT WANT TO
BRAINSTORM HOW MIGHT WE GET
NONACADEMIC INNOVATORS TO GET TO
ACCESS THAT DATA AND DO A TYPE
OF CERTIFICATION PROCESS SO IT'S
CREDIBLE USE, NONABUSE OF THE
DATA BUT THAT CAN DRIVE THE
INNOVATION ECOSYSTEM SO THAT
MORE CREATIVE PRODUCTS AND
SERVICES CAN BE BUILT OFF OF THE
GREAT DATA YOU ALL HAVE
COLLECTED.
THANK YOU.
>>LET'S TALK OFFLINE.
>>APPRECIATE IT.
>>AND I LOVE THE IDEA ABOUT
POLICY.
I HOPE THAT JAN AND TOM ARE
LISTENING AND CAN HELP CONNECT
UST
US, BECAUSE I THINK THAT WOULD
BE WONDERFUL.
>>A GENERAL SUGGESTION WHICH IS
IF YOU -- THESE INFO GRAPHICS
THAT YOU'RE PROVIDING THE
FAMILIES IS AN INSPIRED IDEA AND
I CAN IMAGINE SOMETHING THAT
SIMPLE BEING AVAILABLE IN
PEDIATRICIANS' WAITING ROOMS AND
THAT SORT OF THING SO IT'S VERY
WIDELY AVAILABLE TO THE PUBLIC
IN A SIMPLIFIED WAY, I COULD SEE
THAT AS EXTREMELY USEFUL.
>>WE DO HAVE THEM ON THE
WEBSITE SO WE SHOULD WORK WITH
OUR POLICY AND COMMUNICATIONS
OFFICE TO MORE BROADLY
DISTRIBUTE THEM, BECAUSE YEAH,
THAT'S A GREAT DAY.
>>AND SORRY, I -- [ AWAY FROM
MICROPHONE ].
WESLEY, GO AHEAD.
>>GREAT.
THIS IS WONDERFUL.
IN ALIGN WITH ALL THE POLICY,
OTHER FEDERAL AGENCIES CAN
BENEFIT FROM THIS.
DEALING WITH STATE POLICIES, I
WOULD ALSO ENCOURAGE THE
BIPARTISAN POLICY CENTER SINCE
SEVERAL DECISIONS MADE AT STATE
LEVELS ARE MADE SHALL WE SAY
FROM A PARTISAN PERSPECTIVE,
UNDERSTANDING THE IMPACT OF
THESE ARE GOING TO BE VERY
IMPORTANT.
SO PLEASE CONTINUE TO TRANSLATE
THE DATA FROM THE ACADEMY TO THE
COMMUNITY.
THAT BECOMES VERY IMPORTANT AS
WAS POINTED OUT.
I JUST WANT TO STRESS THAT.
>>THANK YOU.
>>I WANT TO THANK YOU ON BEHALF
OF ALL OF US USERS FOR MAKING
THIS SUCH AN AMAZING RESOURCE.
I WONDERED TO WHAT EXTENT WE'RE
GOING TO FIND OUT HOW
PARTICIPATION IN A LONGITUDINAL
STUDY IMPACTS BEHAVIORS IN
CHILDREN.
THUS FAR IT SEEMS LIKE THEY'RE
KEEPING A PACE WITH MONITORING
THE FUTURE AND OTHER THINGS, BUT
ONE OF THE ASPECTS OF THE STUDY
IN WHICH WE'RE GIVING FEEDBACK
AND GIVING THE CHILDREN
OWNERSHIP OF THEIR PARTICIPATION
MAY RESULT IN A HEALTHIER
POPULATION OR NOT.
WHICH IS GOOD.
BUT WE'LL SEE.
>>RIGHT. THAT'S ALWAYS BEEN
THE INTENTION FROM THE BEGINNING
AND YOU KNOW, WE ARE MOVING IN A
DIRECTION OF GIVING MORE BACK.
BECAUSE THEY DESERVE IT.
THEY'RE PUTTING THE EFFORT IN
AND SO WE REALLY DON'T KNOW
WHETHER THERE IS GOING TO BE
THAT KIND OF IMPACT OR NOT.
BUT THAT HAS BEEN ATTENTION THAT
WE'VE BEEN WRESTLING WITH AND --
BUT HOPEFULLY WE'LL CONTINUE TO
BE ABLE TO CONTINUE TO FOLLOW
THEM AND SEE, YOU KNOW, WHAT
THEY GO INTO AS ADULTS.
>>THANKS VERY, VERY MUCH.
THIS IS REALLY A SPECTACULAR
PROJECT AND I WANT TO THANK YOU
AND YOUR TEAM AND TRACI, YOU'VE
GOT SO MANY LAYERS OF COMPLEXITY
AND IT'S OPENING UP THE WORLD IN
TERMS OF THINGS WE CAN DO AND IT
BASICALLY OPENS UP FOR OUR NEXT
PRESENTATION BECAUSE THE
INSPIRATION THAT WE GET FROM THE
ABCD WAS WHAT ACTUALLY LED US TO
PROPOSE THE OTHER SIDE, THAT
VERY EARLY PREGNANCY, AND NEO
NATAL OUTCOME AND THAT WE'RE
VERY FORTUNATE TO HAVE MICHELLE
TO TAKE INITIATIVE TO GO BY THE
ACRONYMS OR HBCD.
WE USED TO BE BBCD FOR BABY.
SO MICHELLE, WELCOME.
>>THANK YOU FOR THE OPPORTUNITY
TO PRESENT TODAY.
I HOPE TO COME BACK IN A COUPLE
OF YEARS WITH AS AN EXCITING
PRESENTATION AS YOURS.
WE HAVE A LONG WAY TO GO.
AND SOON AS WE GET THE SLIDES
UP -- GREAT.
THANK YOU VERY MUCH.
SO ALSO FIRST I WOULD LIKE TO
JUST THANK THE ABCD TEAM.
THEY'VE BEEN WONDERFUL
COLLEAGUES.
THEY'VE SHOWN US THE WAY.
WE'VE COPIED THEM IN ALMOST
EVERY SINGLE ASPECT OF THE STUDY
BUT ALSO THEY CONTINUE TO SERVE
ON WORK GROUPS FOR HBCD WHILE
DOING THEIR JOB AT ABCD AND I'M
INTERNALLY GRATEFUL FOR THAT.
WE ALSO HAVE A SMALL STAFF
THAT'S DEDICATED TO HBCD THAT
AREN'T HERE TODAY BUT I WANT TO
THANK THEM UPFRONT TOO.
MOUSE?
NOPE.
I SEE.
NOPE.
SORRY, GUYS.
GREAT.
SO SIMILAR TO ABCD, THE HBCD IS
A LONGITUDINAL STUDY THAT WE
WILL PLAN TO RECRUIT
PARTICIPANTS IN THE SECOND
TRIMESTER OF PREGNANCY AND
FOLLOW THEM UP TO TEN YEARS AND
WE WILL BE COLLECTING A VAST
ARRAY OF INFORMATION FROM THESE
INDIVIDUALS. WE'LL BE DOING MRI
IMAGING, COLLECTING A NUMBER OF
BEHAVIORAL AND COGNITIVE
ASSESSMENTS AND ASKING OUR
PARTICIPANTS TO ANSWER A NUMBER
OF QUESTIONNAIRES THROUGHOUT THE
STUDY.
AS DR. VOLKOW MENTIONED WE HAVE
FUNDING FROM THE HEAL
INITIATIVE.
SORRY, I DON'T HAVE THE MOUSE
DOWN.
IT'S NOT WORKING.
NOPE.
I'M A FORMER MAC USER, SO I'M
CLICKING THE WRONG SIDE.
SO THE PROJECT OBVIOUSLY CAME
ABOUT BECAUSE OF THE GREAT
PROMISE THAT ABCD HAS BEEN
DEMONSTRATING BUT ALSO CAME
AROUND THE TIME THAT THE HEAL
NI
INITIATIVE, AND WE WERE ABLE TO
SECURE SOME FUND FROM THE HEAL
INITIATIVE BUT REALLY
CONTRIBUTIONS FROM A NUMBER OF
INSTITUTES AND CENTERS ACROSS
NIH.
THE MAJORITY OF THE WORK IS
MANAGED OUT OF NIDA BUT WE HAVE
CONTRIBUTIONS FROM THE OFFICES
AND CENTERS THAT ARE LISTED
HERE.
AND THE HELPING AND ADDICTION
LONG-TERM IS FOCUSED ON BOTH
ENHANCING PAIN MANAGEMENT AND
IMPROVING TREATMENT FOR OPIOID
USE.
MY LITTLE GROUP THAT'S PART OF
THAT IS THE ENHANCED OUTCOMES
FOR AFFECTED NEWBORNS BUT THIS
IS LOOKING AT DEVELOPMENT ACROSS
A NUMBER OF ENVIRONMENTS, NOT
JUST SUBSTANCE USE.
RIGHT CLICK. IT WORKED.
SO FOLLOWING A PLANNING PERIOD
WHERE WE WERE ALLOWED TO SORT OF
EXAMINE WHAT OBSTACLES WOULD BE
IN THE WAY OF A STUDY OF THIS
NATURE, WE MADE AWARDS TO A
NUMBER OF SITES THAT DID THIS
KIND OF LANDSCAPE ANALYSIS AND
WHAT WOULD BE -- WHAT WOULD IT
TAKE TO DO THIS AND THEN WE
ISSUED AN ANNOUNCEMENT FOR
APPLICATIONS FOR THE FULL STUDY.
IN OCTOBER OF 2020 WE MADE
AWARDS TO 25 RESEARCH SITES
ACROSS THE U.S. AS WELL AS THE
DATA COORDINATING CENTER AND AN
ADMINISTRATIVE CORE.
THE DAY TO COORDINATING CENTER
IS LED BY DR. CHRIS MISER,
DAMEIAN FAIR AT THE UNIVERSITY
OF MINNESOTA AND ANDERS IS ALSO
INVOLVED IN THE ABCD PROGRAM.
THE SITES THAT WERE SELECTED
WERE SELECTED FOR A NUMBER OF
DIFFERENT REASONS BUT ONE IN
PARTICULAR WAS WE WANTED TO
BRING IN SITES THAT WOULD BE
ABLE TO RECRUIT FROM VULNERABLE
POPULATIONS THAT AREN'T NORMALLY
NECESSARILY INVOLVED IN LARGE
RESEARCH PROGRAMS AT LARGE
ACADEMIC INSTITUTIONS AND YOU'LL
NOTICE SOME OF THOSE IN THE
SOUTH, ALABAMA, TENNESSEE,
GEORGIA.
OKAY.
SO THE HBCD STUDY HAS A NUMBER
OF AIMS.
I WON'T READ ALL OF THEM HERE
BUT WE'RE INTERESTED IN
UNDERSTANDING THE NEURAL
TRAJECTORIES, WHAT'S THE NORMAL
RANGE OF VARIABILITY THROUGHOUT
CHILD AND HOW DO OTHER
INFLUENCES CHANGE THOSE
TRAJECTORIES.
ADVERSE ENVIRONMENTS, ETC. AND
ARE THERE KEY AREAS WHERE
INTERVENTIONS MAY BE HELPFUL IN
CHANGING THOSE TRAJECTORIES.
AN WITH A STUDY WITH THIS NUMBER
OF PARTICIPANTS WE AIM TO
RECRUIT 7,500. WE HOPE TO BE
ABLE TO TEASE OUT SOME OF THOSE
CONTRIBUTING FACTORS.
AND IN THE SAMPLES DESIGN, THIS
HAS A LOT OF CLICKS.
WE WANTED TO MAKE SURE THAT
WE'RE ADDRESSING BOTH EXTERNAL
VALIDITY AND INTERNAL VALIDITY
SO WE WANT THE RESULTS TO BE
GENERALIZABLE ACROSS THE
POPULATION IN THE U.S. BUT WE
ALSO WANT TO BE ABLE TO TEASE
OUT CAUSAL INFERENCE, SO MAKING
SURE THAT WE HAVE THE
APPROPRIATE CONTROLS TO MAKE OUR
COMPARISONS.
SO WE'RE LOOKING AT QUESTIONS
SPECIFICALLY ABOUT SUBSTANCE USE
AFFECTS BUT ALSO QUESTIONS ABOUT
OTHER EXPOSURES AND HOW THOSE
MAY INTERACT.
SO AS I MENTIONED, WE'RE GOING
TO BE RECRUITING 7,500 PREGNANT
WOMEN IN THEIR SECOND TRIMESTER
IS THE TARGET ALTHOUGH WE DO
ALLOW FOR SOME RECRUITMENT TO
HAPPEN IN THIRD TRIMESTER AND A
SMALL PERCENTAGE THAT COULD
HAPPEN RIGHT AFTER BIRTH.
WE ARE OVERSAMPLING FOR
SUBSTANCE EXPOSURE BECAUSE THE
INCIDENTS OF SUBSTANCE USE IN
PREGNANCY IN THE POPULATION IS
ABOUT 8%.
WE'RE TARGETING A 25% GROUP FOR
SUBSTANCE USE DURING PREGNANCY
AND THEN MATCHING THAT WITH 25%
POPULATION THAT HAS SIMILAR
ENVIRONMENTS AND RISK FACTORS,
BUT NOT USING SUBSTANCES AND
THEN THAT COMPARED WITH THE
GENERAL POPULATION.
AND THE SAMPLE THAT WE'RE
RECRUITING FROM OUR WOMEN THAT
ARE OF CHILDBEARING AGE IN THE
U.S. AND MATCHES THE U.S.
DEMOGRAPHICS.
SO MANY THINGS NEED TO BE
CONSIDERED IN DESIGNING THE
VISIT STRUCTURE.
ONE, THE ABILITY TO RETAIN
PARTICIPANTS IN A STUDY OF THIS
LENGTH.
WE WANT TO BE VERY CAUTIOUS AND
CAREFUL ABOUT THE BURDEN WE
PLACE ON PARTICIPANT FAMILIES
BUT YET WE WANT TO HAVE A WIDE
RANGE OF DATA THAT WE CAN
COLLECT FROM THEM AND SO
BALANCING WHAT ASSESSMENTS WE
ASK THEM TO DO, HOW OFTEN WE ASK
THEM TO COME IN, AND THE BURDEN
ON THE FAMILIES.
MY SLIDES ARE OUT OF ORDER.
OKAY.
I'M GOING TO SKIP AHEAD.
JUST WANTED TO SHOW YOU HERE THE
TIMELINE FOR THE GENERAL VISIT
STRUCTURE.
WE HAVE FIVE VISITS THAT WILL BE
IN PERSON AND THEN THREE VISITS
THAT ARE CONDUCTED REMOTELY.
THIS IS TO LIMIT HOW MUCH TIME
THEY HAVE TO COME IN.
IN THE FIRST VISIT WE'LL BE
DOING ASSESSMENTS OF THE
BIRTHING PARENT, TAKING BIO
SPECIMENS.
WE'LL BE TAKING BLOOD AND URINE
SAMPLES AT THE FIRST VISIT. AND
THEN WE HOPE TO HAVE THE FAMILY
COME BACK AFTER THE BABY IS BORN
AND THAT WOULD BE THE FIRST TIME
FOR AN MRI AND THAT IS EXPECTED
TO OCCUR IN THE FIRST MONTH
AFTER BIRTH.
WE'LL BE COLLECTING -- CONTINUE
COLLECTING BIO SPECIMENS, DOING
ASSESSMENTS OF THE PARENT AND
THEN WE'RE ALSO SENDING HOME THE
BABY WITH MOTION SENSORS AND
THERE'S A BAND THAT THE BABY
WILL WEAR TO MONITOR HEART RATE
IN SLEEP.
THEY'LL COME BACK AT 3 TO 9
MONTHS, 9 TO 15 MONTHS AND 15 TO
48 MONTHS AND INTERSPERSED IN
THERE ARE THESE REMOTE
ASSESSMENTS THEY CAN DO AT HOME.
IN ORDER TO GET ALL OF THOSE
VISITS IN WITH 7,500
INDIVIDUALS, THE FIRST TWO
VISITS ARE ALL AT THE SAME TIME
POINTS.
SO IN THE THREE MONTH RANGE,
OVER THAT VISIT THREE, SIMILAR
FOR VISIT FOUR AND SO ON.
AND THEY WILL BE -- THE
PARTICIPANTS WILL BE RANDOMIZED
WHEN THEY ARE ENROLLED IN THE
STUDY.
AND THEN THE REMOTE VISITS ARE
YOKED TO THE PREVIOUS VISITS.
IT'S HAD A LOT OF INPUT FROM A
NUMBER OF INDIVIDUALS IN THE
CONSORTIUM.
ONE THING IMPORTANT TO NOTE
ABOUT THE VISIT STRUCTURE IS --
WELL, I FORGET WHAT I WAS GOING
TO SAY HERE.
SORRY.
LET ME JUST MOVE ON.
SO I'VE OUTLINED HERE THE VISIT
ASSESSMENTS, WHAT WILL -- I KNOW
WHAT I WANTED TO SAY.
SO A VISIT ONE OR VISIT TWO,
THREE, SO ON, CAN HAPPEN OVER A
COUPLE OF WEEKS.
SO THE TOTAL VISITS CAN TAKE UP
TO EIGHT HOURS DEPENDING ON WHAT
ALL IS INCLUDED SO WE ARE
ALLOWING THE SITES TO BRING THE
PARTICIPANTS BACK AS LONG AS
IT'S IN A SHORT AMOUNT OF TIME.
AS YOU'LL SEE HERE VISIT ONE,
THERE'S A NUMBER OF ASSESSMENTS.
THIS ONE IS PROBABLY SHORTER
JUST BECAUSE THE BABY ISN'T IN
THE PICTURE YET.
TAKING BLOOD, URINE AND SALIVA
SAMPLE FROM THE MOM AND ASKING
ABOUT THEIR HISTORY.
THE SUBSTANCE USE EXPOSURE WILL
BE TRIGGERED IF THE INDIVIDUAL
FILLS OUT THE ASSIST ASSESSMENT
AND INDICATES SUBSTANCE USE.
THAT WILL THEN SET UP A TIMELINE
TO FOLLOW BACK ASSESSMENT SO WE
GET A BETTER INDICATION OF HOW
MUCH SUBSTANCES WERE USED.
AND THEN THAT WILL BE VALIDATED
OR VERIFIED WITH THE URINE AND
BLOOD SAMPLES.
SO WE ARE COLLECTING A NUMBER OF
BIO
BIO SPECIMENS ACROSS THE STUDY.
WE'RE ONLY DOING URINALYSIS OF
THE MOM'S FIRST AND SECOND
VISIT.
WE'RE ALSO COLLECTING NAIL
SPECIMENS.
THE DATA WILL BE ABLE TO BE USED
BY THE RESEARCH COMMUNITY.
VISIT 2, THESE ARE INCLUDING
MEASURES OF THE CHILDREN, SO
INFANT HEIGHT, WEIGHT, HEAD
CIRCUMFERENCE.
WE'LL BE SENDING THEM HOME WITH
THE BIO SENSORS, WE'LL DO AN MRI
AND THEN AT THE THIRD VISIT IS
WHEN WE BRING IN THE EEG
MEASUREMENT AS WELL AND SOME OF
THE SAME ASSESSMENTS ARE GIVEN
AGAIN AND THERE WILL BE SOME NEW
ONES BROUGHT IN FOR CHILD PARENT
INTERACTION AND SOME LANGUAGE IN
COGNITIVE DEVELOPMENT
ASSESSMENTS.
SO I'D LIKE TO JUST NOW TELL YOU
WHERE WE ARE TODAY.
THIS HAS BEEN ABOUT A YEAR AND A
HALF OF PLANNING.
WE'VE DONE A LOT OF DEVELOPMENT
OF THE PROTOCOL AND BEGAN AT THE
BEGINNING OF THE YEAR TO DO
PILOT WORK TO MAKE SURE THAT THE
PROTOCOL WE DEVELOPED IS
ACTUALLY DOABLE AND HOW MUCH
BURDEN IT IS ON THE FAMILIES,
HOW MUCH BURDEN IT IS ON THE
RESEARCH SITES ETC. SO THIS
GRAPH ILLUSTRATES THE
RECRUITMENT OF PILOT
PARTICIPANTS ACROSS THE FIRST
THREE VISITS, SO WE HAVE
CURRENTLY ENROLLED 345 PARENTS
AND 244 CHILDREN.
THE 20 -- IT'S ACTUALLY 27 SITES
LISTED ON THE BOTTOM.
TWO OF THE AWARDS HAVE
RECRUITMENT SITES AT DIFFERENT
LOCATIONS AND EACH SITE WAS
EXPECTED TO COLLECT THREE
PARTICIPANTS AT EACH TIME POINT.
AND I WANTED TO HIGHLIGHT THIS
IN THE -- IN THE PILOT -- IN THE
PILOT DATA THAT WE HAVE GATHERED
SO FAR, WE'VE BEEN VERY
SUCCESSFUL AT APPROACHING THE
TARGETS THAT WERE SET OUT AT THE
INITIAL START OF THE STUDY.
SO THOSE DEMOGRAPHICS ON THE
LEFT REFER TO THOSE 344 INITIAL
PILOT PARTICIPANTS AND THEN THE
CHART IS ON THE RIGHT.
AND YOU MAY NOTICE THE LEGEND IS
A LITTLE BIT DIFFERENT BETWEEN
THE TWO GRAPHS.
THIS IS THE HBCD TARGETS WAS
BASED ON THE NIH REPORTABLE
CATEGORIES THAT WE COLLECT.
BUT THE DATA THAT ARE SHOWN ON
THE LEFT COME FROM ONE OF THE
DEMOGRAPHIC ASSESSMENTS THAT WE
USED IN THE STUDY AND IT HAS
DIFFERENT OPTIONS.
SO WE -- WE'LL BE GATHERING MORE
DETAILED INFORMATION THROUGH
THOSE ASSESSMENTS.
WE'VE BEEN ABLE TO COLLECT MRI
FROM A NUMBER OF THE
PARTICIPANTS SO FAR, SO THE 0 TO
1 MONTH IS A HARD GROUP TO GET
MOMS TO COME IN, ESPECIALLY FOR
A PILOT STUDY BUT WE'RE PLEASED
TO SHOW THAT WE'VE BEEN ABLE TO
DO THAT AND WE'VE ALSO HAD THE
BABIES COME IN AT THE SECOND --
THE THIRD TIME POINT AS WELL.
THIS IS NOT COMPLETE ACROSS ALL
OF THE SITES YET.
IT GOT A LATER START THAN SOME
OF THE OTHER ASPECTS OF PROTOCOL
BUT WE'RE ENCOURAGED TO SEE THAT
THEY ARE HAVING SUCCESS.
THERE WILL BE IN THE PROTOCOL A
NUMBER OF DIFFERENT MEASURES AND
THEY WILL BE -- I THINK THEY
WILL BE RANDOMIZED IN THE ORDER
OF DIRECTION BECAUSE SOME OF THE
DIFFERENT SEQUENCES TEND TO WAKE
THE BABY UP AND SO WE MAY BE NOT
ABLE TO COLLECT THAT FOR ALL OF
THEM.
AND THEN WE ALSO HAVE RESULTS
FROM THE EEG DATA COLLECTION,
ABOUT HALF OF THE SITES ALREADY
HAD PRETTY DECENT EXPERIENCE
COLLECTING EEG FROM PRIOR
STUDIES AND THEN THE OTHER HALF
HAD TO -- WELL, THEY ALL HAD TO
BUY THE EQUIPMENT AND THEY HAD
TO LEARN HOW TO DO THIS AND SO
THIS GRAPH IS SHOWING THE
SUCCESS RATE ACROSS THOSE
DIFFERENT SITES AS WELL.
SO THE THE BLUE BARS ARE SUCCESS
AND THE ORANGE BARS ARE ONES
THAT HAD FAILED.
AND THEY CONTINUE TO DO THIS IN
THE PILOT PHASE UNTIL WE ARE
READY FOR LAUNCH.
THEY'RE GOING TO KEEP
PRACTICING.
THE WEARABLE TECHNOLOGY AS I
MENTIONED, THE BABIES ARE SENT
HOME WITH SENSORS THAT GO ON
THEIR ANKLES. THEY'RE PUT IN
THESE LITTLE SLEEVES THAT GO
OVER THE LEG AND THEY'RE TO WEAR
THESE FOR 72 HOURS AND THEY WILL
TAKE THE SENSORS OFF THEN AND
MAIL THEM BACK TO THE RESEARCH
SITE WHEN THEY'RE DONE.
THEY WILL ALSO BE WEARING THIS
BAND. IT'S CALLED THE GABBY
BAND AND THAT MEASURES HEART
RATE AND THEY'RE ABLE TO GET
SOME INDEX OF SLEEP AS WELL.
THE GABBY IS A NEW PRODUCT THAT
HAS JUST BEEN DEVELOPED AND SO
WE'RE A LITTLE BIT BEHIND IN THE
COLLECTION OF THOSE DATA, BUT
HOPEFULLY THAT WILL CATCH UP
WITH US VERY QUICK.
THE MOMS WILL ALSO BE FILLING
OUT QUESTIONNAIRE DURING THAT 72
HOURS WHETHER THE DAY WAS A
TYPICAL DAY OR IF, YOU KNOW,
THEY WERE TRAVELING, THERE MAY
BE A REASON WHY THE MOVEMENT IS
LESS, ETC. ON THIS SLIDE I HAVE
PUT SOME OF THE PILOT DATA FROM
THE BIO SPECIMEN COLLECTION.
WE ARE COLLECTING A VIAL OF
BLOOD FROM THE PREGNANT PERSON
AND THEN THEY ALLOCATE THAT OUT
AND SEND THOSE ON TO THE
REPOSITORY AS WELL AS
EXPECTATION TO COLLECT URINE AND
SCHOOL FROM THE BABIES.
THOSE WILL ALSO BE SENT TO THE
BIO REPOSITORY AND SALIVA IS
SELECTED AND DNA IS BEING
EXTRACTED.
SO THE BOTTOM GRAPH SHOWS ACROSS
THE SITES AND THE TYPES OF
SAMPLES THEY'VE SENT IN SO FAR.
THESE DATA ARE LAGGING BEHIND
WHAT HAVE BEEN COLLECTED.
I WOULD IMAGINE THE SPECIMENS
RECEIVED WILL INCREASE GREATLY.
BUT WHAT'S MOST INTERESTING TO
ME ON THIS SLIDE IS THE
SUBSTANCE USE FROM THE ANALYSIS
OF THE URINE SAMPLES THAT WERE
SENT TO USDTL AND THE ABILITY TO
COMBINE THAT WITH DATA WE
COLLECTED FROM THE TIMELINE
FOLLOW BACK.
SO ON THE TOP IS POSITIVE FOR
USE ON THE TIMELINE FOLLOW BACK.
SO AN INDIVIDUAL FILLS OUT WHEN
AND WHERE OR HOW OFTEN THEY'VE
USED AND THEN THE PINK BAR SHOWS
A POSITIVE BIO SPECIMEN, AND
THEN ON THE BOTTOM GRAPH, THE
YELLOW BAR INDICATES WHERE THOSE
TWO HAD THAT IN COMMON.
SO IN SOME CASES WE DON'T HAVE
THE PERFECT MATCH OF DATA FROM
BOTH ASSESSMENTES, BUT
ULTIMATELY WE WILL AND THAT'S
HOW WE'LL BE CONFIRMING
SUBSTANCE USE.
AND THEN I THINK THIS IS MY LAST
SLIDE.
BUT THIS SHOWS THE ANALYSIS OF
THE URINE SAMPLE FROM USDTL.
ON THE LEFT IS FROM A SUBSET OF
63 PILOT PARTICIPANTS AND
SHOWING POSITIVITY IN SIX
CATEGORIES AND THAT'S COMPARED
TO THE NATIONAL POSITIVITY RATE
FROM THIS LAB.
AGAIN, IT'S A VERY SMALL NUMBER
BUT WE ARE REALLY PLEASED TO SEE
THAT WE ARE TARGETING EVEN
THROUGH OUR PILOT PARTICIPANTS
THE POPULATION WE HOPE TO
RECRUIT IN THE STUDY.
SO AN UPDATE ON WHEN WE WILL
ACTUALLY LAUNCH, NORA HAD AN OLD
SLIDE YESTERDAY AND IT SAID WE
WOULD LAUNCH IN MAY.
WE ARE ACTUALLY EXPECTING TO DO
A FULL LAUNCH STARTING JULY 1ST
OF THIS YEAR.
AND I'M HAPPY TO ANSWER ANY
QUESTIONS.
>>MICHELLE, THANKS VERY MUCH.
ANY QUESTIONS?
THANK YOU SO MUCH.
THE ONE QUESTION I WANTED TO
HIGHLIGHT ESPECIALLY AS THE
BABIES ARE GROWING AND BECOMING
TODDLERS IS NUTRITION DATA.
ARE YOU COLLECTING THAT.
>>SO WE'RE COLLECTING A SMALL
AMOUNT OF NUTRITION DATA THROUGH
QUESTIONNAIRE.
>>THERE WAS A PROPOSAL TO DO A
MORE IN DEPTH ONE BUT WE WOULD
LIKE TO GET MORE INFORMATION IF
POSSIBLE.
YEAH.
>>GOOD.
>>ARE YOU GUYS COLLECTING
INSURANCE TYPE AS A VARIABLE?
>>INSURANCE TYPE, I'M SURE
WE'LL HAVE THAT INFORMATION IN
THE MEDICAL RECORDS FOR SURE.
NO?
>>I DOUBT IT ACTUALLY IN THE
MEDICAL RECORD.
YEAH, IT MIGHT BE IN
ADMINISTRATIVE DATA BUT THE
STUFF YOU TYPICALLY CRAWL OR
SCRAPE IN THE DHR, WE ARE NOT
VERY GOOD AS CLINICIANS
>>THERE'S A LOT OF DEMOGRAPHIC
QUESTIONS THAT WOULD GET AT
THAT.
>>IF THERE'S ANY WAY TO GO
BACK.
>>YOURS DOES?
OKAY. THEN I GUESS IT DOES.
>>AMAZING.
THAT WILL BE RELEVANT TO TEASE
OUT ESPECIALLY LOOKING AT
ASSOCIATIONS BETWEEN INSURANCE
CHURN ESPECIALLY NOW AS KIDS
POPPING OFF OF MEDICAID, IF THEY
GET COVERAGE AGAIN, DO THEY GO
AND EXCHANGE OR EMPLOYER
INSURED, THAT'S GOING TO BE VERY
RELEVANT FOR A LOT OF THIS
STUFF.
THANK YOU.
>>OTHER QUESTIONS?
HOW LONG WILL YOU STAY IN
CONTACT WITH YOUR SUBJECTS HERE?
IS THIS ONGOING PROCESS OF
COLLECTING DATA AND WHAT'S THE
FINAL PERIOD AND WHAT WILL
HAPPEN WITH THEM?
>>WE'RE HOPING TO HAVE THEM FOR
TEN YEARS.
WE HAVE A NUMBER OF TOUCH POINTS
THROUGHOUT THE STUDY WHERE WE
WILL KEEP IN CONTACT WITH THEM
WITHOUT NECESSARILY BRINGING
THEM IN TO INCREASE RETENTION,
SO LIKE ABCD DOES.
>>WHILE WE ARE WAITING I
JUST --
>>I JUST WANT TO CONGRATULATE
YOU ON AN INCREDIBLE EFFORT.
WE DO THIS ON A SMALL SCALE AND
THIS IS PHENOMENAL.
IT'S GOING TO BE SO MUCH WORK.
>>HOPEFULLY IT GETS BETTER
BECAUSE IT HAS BEEN TRICKY.
>>YOU KNOW, MOMS IN A PERIOD OF
TIME WHEN THEY NEED A LOT OF
RESOURCES, YOU'RE GETTING THEM
TO SCANNING, BABIES NEED TO GO
TO SLEEP TO GO THROUGH SEQUENCES
AND ALL THE BIO SPECIMENS, I
THINK THIS PROJECT IS GOING TO
BE A TREASURE FOR US.
>>HER HUSBAND PARTICIPATES IN
THIS STUDY AS ONE OF THE
INVESTIGATORS AND SHE'S RIGHT.
THERE'S A LOT THAT I DIDN'T
COVER AT ALL HERE THAT GOES INTO
HOW WE'RE GOING TO KEEP THEM IN
THE STUDY.
THERE'S A LOT OF EFFORTS AT
PROVIDING RESOURCES, PROVIDING
OUTREACH AND THOSE SORTS OF
THINGS THAT WILL HOPEFULLY HELP
THE PEOPLE WANT TO STAY IN THE
STUDY.
>>AND THAT -- SORRY.
YES, PLEASE.
>>THANK YOU.
I THINK WITH ANY STUDY THAT'S
THIS INTENSE AND THAT COVERS
ISSUES, YOU KNOW, OBVIOUS THAT
COVERS ISSUES THAT ARE
POTENTIALLY STIGMATIZED OR
LIKELY STIGMATIZED.
I WAS VERY HAPPY TO SEE A COUPLE
OF THINGS.
ONE IS THAT YOU'RE GETTING RATES
OF SUBSTANCE USE IN YOUR PILOT
THAT ARE SIMILAR TO WHAT YOU
WOULD EXPECT.
BECAUSE -- AND THAT AMONG THOSE
WHO YOU INCLUDED, THE
SELF-REPORT IS FAIRLY ALIGNED
WITH THE BIOLOGICAL SPECIMENS
BECAUSE I WOULD IMAGINE THAT
THERE'S GOING TO BE A LOT OF
UNDERREPORTING SUBSTANCE USE AND
THAT I WORRY MORE ABOUT THE
PEOPLE YOU DON'T GET IN THE
STUDY THAN THE PEOPLE WHO ARE IN
THE STUDY BECAUSE THEY'RE --
>>MOTIVATED --
>>RIGHT.
THE CONVERTS.
THEY'VE CONSENTED.
THEY'RE AGREEING TO PARTICIPATE,
THEY'RE AGREEING TO ANSWER
HONESTLY.
SO I WONDER IF YOU COULD TALK A
LITTLE BIT ABOUT HOW YOU MANAGE
THAT BECAUSE WITH ANY VULNERABLE
POP
POPULATIONS, YOU KNOW, IT CAN
AFFECT REPORTING, IT'S REALLY
CRITICAL THAT YOU ENGAGE THE
PARTICIPANTS REALLY WELL AND I
WONDER HOW YOU'VE DONE THAT.
>>I THINK WE WERE LUCKY IN THE
PIE LOT.
I'M NOT SURE THAT ALL OF OUR
RESOURCES THAT WE HAVE PLANNED
WERE ACTUALLY INVOKED FOR THE
PILOT PART BUT ONE OF THE THINGS
THAT I THINK WE'RE VERY PROUD OF
IN THE STUDY IS WE'VE INCLUDED
STUDY NAVIGATORS AT EACH OF THE
SITES. SOME OF THOSE STUDY
NAVIGATORS HAVE CERTIFICATION
PEER RECOVERY SPECIALISTS SO
HAVE LIVED EXPERIENCE THAT THEY
CAN RELATE TO, BUT REALLY EVEN
THE STUDY NAVIGATORS WITHOUT
THAT CERTIFICATION, THAT IS THE
GOAL OF THEIR JOB IS TO REALLY
WORK WITH THESE COMMUNITIES AND
TRY TO MAKE IT FEEL LIKE A SAFE
PLACE WHERE THEY BELONG AND
WHERE THEIR CONTRIBUTION IS
REALLY IMPORTANT.
SO I THINK THAT'S A UNIQUE
ASPECT OF THE STUDY.
AND RECRUITING FROM TREATMENT
CENTERS A WIDE RANGE OF
DIFFERENT PLACES WHERE WE'RE
HOPING TO REACH THESE
PARTICIPANTS.
>>I WANTED TO COMMENT ON THAT
BECAUSE THE CHALLENGE OF THE
HBCD BRINGS IT EVEN MUCH HARDER
THAN THE ABCD BECAUSE YOU'RE
HAVING PREGNANT WOMEN WHO ARE
TAKING DRUGS AND THAT ALSO SETS
IMPLICATIONS FOR STATES THAT
ACTUALLY CRIMINALIZE THOSE WOMEN
WHO ARE TAKING DRUGS.
SO ONE OF THE MAIN CHALLENGES IS
NOT TO DO ANY HARM TO THOSE
PAR
PARTICIPANTS.
I REALIZE THE ENORMOUS
COMPLEXITY OF RETAINING THESE
WOMEN AND THEIR CHILDREN BECAUSE
WE'RE AIMING TOWARDS ADDRESSING
WOMEN THAT ARE GOING TO BE
EXTRAORDINARILY VULNERABLE. BUT
WE NEED TO BITE THE BULLET AND
TRY TO FIGURE OUT HOW WE CAN GET
IT DONE AND I KNOW MICHELLE AND
HER TEAM HAVE BEEN WORKING
REALLY INCREDIBLY HARD TO MAKE
THIS POSSIBLE AND WE LOOK
FORWARD TO GET THE UPDATE NEXT
YEAR AND ALL ALONG, BUT YOU'RE
ALL VERY WELCOME TO KEEP IN
TOUCH AND PARTICIPATE WITH YOUR
SUGGESTIONS, SO MICHELLE AND
YOUR TEAM, THANKS VERY, VERY
MUCH.
>>THANK YOU.
>>FOR TAKING THE LEAD ON THIS.
THANKS A LOT AND I THINK THAT
NOW WE CAN ADJOURN FOR LUNCH.
GEORGE?
>>YEAH.
I JUST WANT TO ALSO OFFER MY
CONGRATULATIONS TO BOTH ABCD AND
HBCD BECAUSE I'M ASSUMING
EVERYBODY HERE REALIZES HOW MUCH
WORK GOES INTO COORDINATING AND
WORKING THROUGH THESE EFFORTS,
BUT THE RICHNESS OF THE DATABASE
IS EXTRAORDINARY AND SO I MAY
NOT BE AS PROUD AS NORA BECAUSE
NORA HAS BEEN PUSHING BOTH OF
THESE STUDIES WITH ALL OF HER
ENERGY, BUT I'M VERY, VERY PROUD
THAT WE'RE PART OF IT.
SO THANKS, BOTH OF YOU.
>>WE CAN ADJOURN FOR LUNCH.
>>WHEN DO YOU WANT US TO COME
BACK?
>>WE WILL BE STARTING AT 1:30.
SO GET HERE TEN MINUTES BEFORE
1:30 WE CAN GET STARTED ON TIME
AT 1:30.
OKAY.
>>EVERYONE, WE WILL START AT
1:30.
>>BE HERE AT 1:20 SO WE CAN
START AT 1:30.
IT'S A GREAT PLEASURE TO
INTRODUCE DR. JEFF BOISSONEAULT,
WHO IS GOING TO TALK TODAY ABOUT
ALCOHOL AND PAIN, SPECIFIC TITLE
IS DECODING BIDIRECTIONAL
INTERACTION BETWEEN ALCOHOL AND
PAIN.
DR. BOISSONEAULT SERVES AS
ASSOCIATE PROFESSOR IN
DEPARTMENT OF ANESTHESIOLOGY AT
UNIVERSITY OF MINNESOTA WHERE HE
DIRECTS THE MINNESOTA ALCOHOL
AND PAIN LAB.
HE WAS ASSOCIATE PROFESSOR UNTIL
RECENTLY, CO-DIRECTOR OF THE
PAIN RESEARCH AT UNIVERSITY OF
FLORIDA, RESEARCH INTERESTS
FOCUS ON NEUROPHYSIOLOGIC AND
PSYCHOSOCIAL MECHANISMS
UNDERLYING THE BIDIRECTIONAL
ASSOCIATION BETWEEN PAIN AND
SUBSTANCE USE, ALSO INVOLVED IN
STUDIES REGARDING CORTICAL
BRAINSTEM REACTION UNDERLYING
PLACEBO ANALGESIA AND
NON-PHARMACOLOGIC APPROACHES TO
IMPROVE PAIN MODULATORY CAPACITG
QUESTIONS OR SPEAKING.
>>NOW THAT WE HAVE THE PATENT
AND WE HAVE THIS IN ENGLISH AND
WE HAVE A PARAGRAPH FOR THE
PROTOCOL, --
>>THANK YOU FOR THAT
INTRODUCTION.
I'M DELIGHTED TO BE ABLE TO
PRESENT TODAY.
I'M SORRY I COULDN'T BE THERE IN
PERSON BUT WE JUST MOVED TO
MINNESOTA, IT WAS NOT A GOOD
TIME TO GET BACK ON PLANE AND
TRAVEL.
SO, THANK YOU FOR THE
INVITATION.
I'LL BE TALKING ABOUT A RECENT
WORK REGARDING BIDIRECTIONAL
ASSOCIATIONS BETWEEN ALCOHOL AND
PAIN.
AND FIRST I WANT TO START BY
ACKNOWLEDGING ALL OF THE FOLKS I
WORK WITH TO ACTUALLY GET THIS
DONE, THE NUMBER OF
COLLABORATORS AT THE UNIVERSITY
OF FLORIDA ACROSS THE COUNTRY,
POSTDOCS, GRADUATE STUDENTS,
STAFF AND FUNDING SUPPORT FROM
NIAAA, U.S. CENTER FOR ADDICTION
RESEARCH HAVE ALL BEEN REALLY
IMPORTANT PLAYERS IN THIS WORK.
THANKS TO EVERYONE.
I'M GOING TO GIVE A BRIEF
DIRECTION AND STUDIES LOOKING AT
PAIN AS A APPROXIMATELY
ANTECEDENT FOR ALCOHOL USE,
EXPERIMENTAL STUDIES, FOLLOWED
BY EXPERIMENTAL STUDIES
REGARDING ACUTE ANALGESIC
EFFECTS OF ALCOHOL, AND THEN
FINALLY CONCLUDE WITH DISCUSSION
AND FUTURE DIRECTIONS.
I THINK EVERYBODY IS PRETTY
AWARE OF THE BURDEN THAT CHRONIC
PAIN AND PAIN IN GENERAL PLACES
ON SOCIETY.
SO ABOUT 1 IN 5 U.S. ADULTS HAVE
CHRONIC PAIN.
8% HAVE HIGH IMPACT CHRONIC PAIN
THAT LIMITS ACTIVITIES ON MOST
DAYS, ELEVATED AMONG CERTAIN
GROUPS INCLUDING OLDER ADULTS,
WOMEN, VETERANS, AND THOSE
LIVING IN POVERTY.
OVERALL COST TO THE U.S. ECONOMY
ARE STAGGERING OVER $600 BILLION
PER YEAR, JUST IN THE U.S.
AND UNFORTUNATELY, OUR FRONTLINE
TREATMENTS FOR CHRONIC PAIN HAVE
RELATIVELY POOR EFFICACY AND
SIGNIFICANT SIDE EFFECTS
INCLUDING OPIOIDS.
IN THAT CONTEXT IT'S NOT
SURPRISING THAT APPROXIMATELY 25
TO 40% OF INDIVIDUALS ENGAGE IN
USE OF ALCOHOL TO SELF-MANAGE
PAIN.
THIS DATA COMES FROM A 2009
SURVEY FROM RILEY AND KING OF
INDIVIDUALS WITH ORAL FACIAL OR
ARTHRITIS PAIN, FOUND SEVERAL
RISK FACTORS TENDING TO
PREDISPOSE FOLKS.
THAT INCLUDED BEING MALE,
YOUNGER, HAVING MORE SEVERE
PAIN, HIGHER SES, WHITE RACIAL
IDENTITY, GREATER DEPRESSION,
LONGER PAIN DURATION, AND
CONCERNINGLY GIVEN THE DATA THAT
DR. KOOB PRESENTED EARLIER ABOUT
THE ROLE OF ALCOHOL IN OPIOID
OVERDOSES, OPIOID CONSEQUENCES,
USE OF PRESCRIPTION ANALGESICS
WAS ASSOCIATED WITH GREATER
LIKELIHOOD OF USING ALCOHOL FOR
PAIN SELF-MANAGEMENT.
SO THERE ARE A NUMBER OF RISKS
AND CONCERNS THAT ARE ASSOCIATED
WITH THIS BEHAVIOR.
ONE IS THAT ABOUT 3/4 OF THE
MOST PRESCRIBED DRUGS IN THE
U.S. HAVE POTENTIALLY HARMFUL
INTERACTIONS WITH ALCOHOL THAT
INCLUDES ALL OPIOID ANALGESICS,
ANTIDEPRESSANTS, NSAIDs,
ACETAMINOPHEN, GABAPENTIN.
POLYPHARMACY IS COMMON.
BENZODIAZEPINES AND MUSCLE
RELAXANTS, EXCEEDING MODERATE
DRINKING GUIDELINES.
CHRONIC HEAVY USE OF ALCOHOL CAN
INCREASE RISK OF DEVELOPING A
PAINFUL ALCOHOL-RELATED
NEUROPATHY WHICH AFFECTS 25 TO
60% OF PEOPLE WITH ALCOHOL USE
DISORDER AND RELIEF FROM
DRINKING ALCOHOL WITH PROVIDE
AADDITIONAL NEGATIVE
REINFORCEMENT.
ALCOHOL WITHDRAWAL INCREASES
PAIN SEVERITY AND SENSITIVITY,
REPEATED BINGE-WITHDRAWAL CYCLES
INCREASE PAIN AND EXACERBATION
AND ALCOHOL USE IN ITSELF
RESULTS IN SIGNIFICANT COST
EVERY YEAR.
THIS IS A REALLY NICE SCHEMATIC
FIGURE FROM 2009.
THERE ARE ACUTE AFFECTS.
ANALGESIC ESPECIALLY IN SHORT
TERM, ABSTINENCE INDUCED
HYPERALGESIA, INCREASED RISK OF
DEVELOPING CHRONIC PAIN.
AT THE SAME TIME, PAIN CAN HAVE
SIGNIFICANT EFFECTS ON SUBSTANCE
USE, CAN MOTIVATE SUBSTANCE USE,
INCLUDING AS A MEANS OF COPING
WITH PAIN, CAN ACT AS BARRIER TO
CESSATION, INCREASE RISK OF
DEVELOPING SUBSTANCE USE
DISORDERS, A VICIOUS CYCLE WHERE
PAIN AND SUBSTANCE USE CAN
INCREASE -- CAN BE INVOLVED IN
MAINTENANCE AND PROGRESSION OF
BOTH CONDITIONS, SO IT'S
IMPORTANT WE DISENTANGLE AND TRY
TO BETTER UNDERSTAND WHAT'S
GOING ON HERE MECHANISTICALLY.
MY COLLEAGUES AND I PUT TOGETHER
A MODEL, THEORETICAL MODEL,
LOOKING AT THE PAIN SUBSTANCE
USE DIRECTION OF THE FIGURE I
SHOWED BEFORE.
SO REALLY TRYING TO DRILL DOWN
AND DEFINE A TESTABLE MODEL
FOCUSED ON MODIFIABLE
PSYCHOSOCIAL FACTORS, LOOKING AT
WHAT MIGHT BE DRIVING THAT
PROXIMAL RELATIONSHIP BETWEEN
PAIN AND THEN USE OF SUBSTANCES
INCLUDING ALCOHOL.
SO WE CALL THIS THE CANUE MODEL,
I MENTION IT BECAUSE WE'RE
EXCITED ABOUT TESTING THIS MODEL
FURTHER AND WE HAVE SOME DATA
THAT I'M GOING TO SHOW IN A
COUPLE MINUTES SHOWING THAT
EXPECTANCY AND PAIN-RELATED
NEGATIVE AFFECT ARE ALREADY
PLAYING A HYPOTHESIZED ROLE.
WE DO POINT OUT NON-MODIFIABLE
BIOLOGICAL AND PSYCHOSOCIAL
FACTORS THAT ARE IMPORTANT HERE,
SO THIS COULD INCLUDE RACE AND
ETHNICITY, SEX, GENDER IDENTITY,
SOCIOECONOMIC STATUS, HISTORY OF
SUBSTANCE USE, HISTORY OF MOOD
DISTURBANCE FOR MENTAL HEALTH
DISORDERS AND PEOPLE'S PAIN
CHARACTERISTICS SO DURATION OF
THEIR PAIN, SEVERITY AND
UNPLEASANTNESS, FREQUENCY,
MUSCULOSKELETAL OR CANCER
RELATED TO PLAY A ROLE.
THERE'S GROWING EVIDENCE IT'S A
PREDISPOSING FACTOR ACROSS THE
ADULT LIFESPAN.
WE'VE DONE SOME WORK IN COLLEGE
STUDENTS AND THERE'S PUBLISHED
DATA FROM MOOD IN THE MID-2000S
SHOWING THAT APPLIES TO OLDER
ADULTS.
KATIE HAS SHOWN USING DATA FROM
THE U.K. STUDY AND PROJECT
COMBINE THAT GREATER SEVERITY IS
ASSOCIATED WITH GREATER ODDS TO
RETURN TO DRINKING, FLIPPING
THIS IN A POSITIVE DIRECTION
WE'VE SHOWN IN RECENT DATA FROM
TREATMENT, RESIDENTIAL TREATMENT
SEEKERS IN NORTH CENTRAL FLORIDA
THAT REDUCTION IN PAIN SEVERITY
OVER THE COURSE OF RESIDENTIAL
TREATMENT OR EARLY ABSTINENCE
PREDICTS REDUCED CRAVINGS,
GETTING TO EFFECTIVE PAIN
MANAGEMENT AND TREATMENT MAY BE
AN IMPORTANT WAY TO HELP IMPROVE
OUTCOMES FOR FOLKS.
EXPERIMENTALLY, IT'S BEEN SHOWN
THAT PAIN INCREASES URGE AND
INTENTION TO DRINK IN HEALTHY
YOUNG ADULTS.
WE HAVE -- WANTED TO BUILD OFF
FINDINGS SHOWING PAIN WAS
INCREASING URGENT INTENTION TO
DRINK BY GETTING INTO OTHER
ASPECTS OF THAT CONSTRUCT.
SO OUR FIRST ATTEMPT WAS THE
STRENGTH TRAINING AND ALCOHOL
CONSUMPTION STUDY, TAKING A
BEHAVIORAL ECONOMIC APPROACH TO
THIS.
THIS STUDY WE HAD 53
PARTICIPANTS, 30 WERE WOMEN,
COMPLETE E-CENTRIC EXERCISE OF
THE BICEP, OR LOW INTENSITY
CONCENTRIC, SHAM DOMES, DOES NOT
PRODUCE MUSCLE SORENESS.
e-CENTRIC PEAKS 24-48 HOURS
AFTER EXERCISE.
WE ASSESSED DEMAND FOR ALCOHOL
BEFORE EXERCISE AND 48 HOURS
AFTER EXERCISE WHEN WE EXPECTED
PAIN TO PEAK.
AND WE LOOKED AT SEVERAL
MEASURES DERIVED FROM ALCOHOL
PURCHASE TASK INCLUDING
INTENSITY, NUMBER OF DRINKS THAT
AN INDIVIDUAL WOULD DRINK IF
THEY WERE FREE IN A HYPOTHETICAL
SCENARIO, BREAK POINT WHICH IS
PRICE OF A DRINK WHERE AN
INDIVIDUAL REPORTS NO
CONSUMPTION, O-MAX, THE MAXIMUM
AMOUNT AN INDIVIDUAL WOULD SPEND
ON ALCOHOL, PMAX, PRICE FOR
DEMAND BECOMES ELASTIC IN
ESSENTIAL VALUE WHICH REFLECTS
THE INDIVIDUAL'S OVERALL
SENSITIVITY TO PRICE OF ALCOHOL.
SO IT REFLECTS ITS MORE GENERAL
INDEX OF DEMAND.
SO STARTING WITH THE SANITY
CHECK WE DID FIND THAT THE
E-CENTRIC INTERVENTION OR DOMES
PRODUCED PAIN.
WE SEE A VERY LARGE DIFFERENCE
BETWEEN OUR DOMES GROUP AND SHAM
DOMS GROUP.
AND WE FOUND A PATTERN OF
INTERESTING GENDER DIFFERENCES
IN THE RESPONSE OF ALCOHOL
DEMAND TO MUSCULOSKELETAL PAIN
AND FOUND FOR MEN INTENSITY FOR
MEN IN THE DOMS GROUP TENDED TO
INCREASE FROM PRE-TO POST
EXERCISE.
BUT THAT WAS NOT THE CASE FOR
WOMEN.
FOR BREAK POINT WE FOUND
DIVERGENT PATTERN.
MEN, AGAIN, INCREASED IN BREAK
POINT AFTER THAT INDUCTION
MUSCULOSKELETAL PAIN BUT WOMEN
DECREASED IN BREAK POINT WHICH
WAS VERY INTERESTING.
SO, WE WANTED TO FOLLOW UP BY
LOOKING NOT JUST AT WHAT IS THE
EFFECT ON ALCOHOL OF PAIN ON
MOTIVATION TO USE ALCOHOL OR
REINFORCING EFFECT OF ALCOHOL
BUT ALSO THE EFFECT OF PAIN ON
THE WAY THAT PEOPLE CONSUME
ALCOHOL OR DRINKING TOPOGRAPHY.
DRINKING TOPOGRAPHY REFLECTS THE
MICROSTRUCTURE LIKE SIP
INTERVAL, SIP VOLUME, TOTAL
AMOUNT CONSUMED, WHICH CAN
AFFECT THE PHARMACOKINETICS OF
ALCOHOL DURING THE
SELF-ADMINISTRATION SESSION WITH
THE IDEA PEOPLE DRINKING MORE
RAPIDLY WILL HAVE GREATER AND
FASTER RISES IN BAC, WHICH CAN
INCREASE ALCOHOL-RELATED RISK.
WE HAD FOLKS COME INTO THE LAB,
20 PARTICIPANTS, HALF WOMEN, AND
COMPLETED TWO
SELF-ADMINISTRATION SESSIONS, UP
TO ONE DRINK IN VIRTUAL REALITY
WHICH I'LL SAY MORE ABOUT IN A
MINUTE, WHILE DRINKING THEY
EITHER EXPERIENCED HEAT PAIN, ,
YOU CAN SEE ON THE THERMODE, AND
OR NON-NOXIOUS, COMPARED BETWEEN
HEAT PAIN AND WARMTH.
TO SAY MORE ABOUT THIS PLATFORM,
VIRTUAL REALITY PLATFORM,
RESEMBLING A TYPICAL BAR.
WE'VE STRAPPED A TRACKER TO THE
DRINK SO IT'S REPRESENTED IN THE
VIRTUAL SPACE, THEY ARE ABLE TO
PICK IT UP, DRINK IT AND PUT IT
DOWN ON THE COASTER, ALSO A
SCALE, TRANSMITTING WEIGHT DATA
REMOTELY TO A COMPUTER WHICH YOU
CAN'T SEE IN THE SHOT.
WE KNOW THE VOLUME OF EACH
INDIVIDUAL SIP AND TIME THAT
BETWEEN SIPS, SIP INTERVALS.
WE HAVE A TRACKER ON THE WRIST
SO THEY KNOW WHERE THEIR HAND IS
IN SPACE AND THAT FACILITATES
THE DRINKING.
THIS IS A SCREEN CAPTURE OF WHAT
THE BAR LOOKS LIKE.
IT'S A PRETTY TYPICAL BAR
ENVIRONMENT.
THE ONLY THING I'LL POINT OUT
THERE'S A VIRTUAL DRINKER
PRESENT IN THE SCREEN SHOT IT
WAS NOT HERE FOR THE STUDY.
HEAT PAIN CONDITION DID PRODUCE
GREATER PAIN INTENSITY THAN
NON-NOXIOUS CONDITION, AND THIS
IS JUST ANOTHER ILLUSTRATION OF
HOW WE DEFINE SIP INTERVAL AND
SIP VOLUME USING TIME SERIES
DATA THAT WE DERIVED FROM OUR
SCALE IN THE VIRTUAL REALITY
ENVIRONMENT.
A REPRESENTS SIP INTERVAL, AND
-- I'M SORRY FROM WHEN THEY PUT
THE DRINK DOWN TO PICK IT UP
AGAIN, AND B IS DIFFERENCE IN
WEIGHT BETWEEN SIPS.
WE CAN TAKE THAT DIFFERENCE AND
KNOW THAT THAT WAS THE VOLUME OF
AN INDIVIDUAL SIP.
WE FOUND PAIN AFFECTED DRINKING
TOPOGRAPHY OF MEN BUT NOT WOMEN.
THE RED LINE IS SIP INTERVAL IN
WOMEN, YOU CAN SEE BETWEEN THE
PAINFUL HEAT CONDITION AND WARM
CONDITION THERE WAS NO
DIFFERENCE.
MEN DRINK FASTER IN THE HEAT
CONDITION.
WE WANTED OFFED TO LOOK AT
PUTATIVE RISK FACTORS IN THE
CANUE MODEL.
NEGATIVE URGENCY IS HIGHLIGHTED,
WHAT WE FOUND THROUGH LINEAR
REGRESSION ANALYSIS IS THAT
INDIVIDUALS REGARDLESS OF GENDER
WHO HAD HIGHER NEGATIVE URGENCY
EXPERIENCED GREATER DECLINE IN
SIP INTERVAL FROM PAINFUL --
WARM CONDITIONS TO HEAT
CONDITION, IN OTHER WORDS HEAT
WAS SHORTENING SIP INTERVALS
MORE IN PEOPLE WITH GREATER
NEGATIVE URGENCY.
THAT WAS CONSISTENT WITH
PREDICTIONS.
SHIFTING GEARS, ANALGESIC
EFFECTS OF ALCOHOL, THERE'S A
LOT OF ANECDOTAL AND CLINICAL
REPORTS THAT DATE BACK TO 1513,
PUBLISHED DISSERTATION, PRETTY
INTERESTING, THERE'S CONSISTENT
LABORATORY EVIDENCE THAT WAS
COMPILED BY THOMPSON IN 2017
ALCOHOL INCREASES PAIN
THRESHOLDS, THE OVERALL EFFECT
SIZE, DECREASES PAIN INTENSITY
IN HEALTHY INDIVIDUALS SO THIS
IS IN PEOPLE WITHOUT PAIN AND
EXPERIMENTAL SETTINGS USING A
VARIETY OF PAIN INDUCTION
METHODS, COULD BE PRESSURE,
HEAT, ELECTRIC SHOCK, COLD, ALL
SORTS OF THINGS.
LIMITATIONS, THEY WERE OFTEN
LIMITED TO MEN ONLY, PEOPLE
WITHOUT CHRONIC PAIN.
THAT BRINGS ME TO ANALGESIC
EFFECTS, NIAAA FUNDED R21, THOSE
REPORTS ARE NOW STARTING TO COME
OUT, THIS WAS 48 INDIVIDUALS, 36
WERE WOMEN, 19 CHRONIC JAW PAIN,
TWO DOUBLE BLIND TESTING
SESSIONS, ONE RECEIVED
ALCOHOL-CONTAINING BEVERAGE, .08
PER DECILITER AFTER THEY
CONSUMED BEVERAGE WE WAITED 30
MINUTES, APPROXIMATE PEAK OF
BRAC, PERFORMED PRESSURE AL
GOMETRY, ASSESSED PAIN THRESH
HOLD, INTENSITY TO THREE
LEVELS, AS WELL AS RATINGS OF
PERCEIVED PAIN RELIEF.
THERE ARE A COUPLE TAKEAWAYS.
ONE, AS WE WOULD EXPECT PEOPLE
WITH CHRONIC JAW PAIN DID REPORT
GREATER PAIN INTENSITY AT ALL
PRESSURE LEVELS
THERE WAS NO INTERACTION OF
CHRONIC PAIN STATUS AND
CONDITION SO THAT'S TO SAY
ANALGESIC EFFECTS WEREN'T
SIGNIFICANTLY DIFFERENT
REGARDLESS OF CHRONIC PAIN OR
NOT.
THAT WAS CONTRARY TO
EXPECTATION.
WE EXPECTED SOME MODULATION OF
ANALGESIC EFFECTS IN PEOPLE WITH
CHRONIC JAW PAIN.
ANOTHER THING TO HIGHLIGHT IS
THAT THE CHANGES IN THRESHOLD
AND INTENSITY THAT WE NOTICED AS
A RESULT OF ALCOHOL INTAKE WERE
30% CHANGE.
THE EFFECT OF ALCOHOL ON
PERCEIVED PAIN RELIEF COMPARED
TO PLACEBO WAS 500% CHANGE.
SO A VERY SIGNIFICANT
DIFFERENCE, PEOPLE REPORTED
SIGNIFICANT PAIN RELIEF COMPARED
TO PLACEBO CONDITION AND ALCOHOL
CONDITION.
AND INTERESTING FACET, THAT THE
CHANGE IN PAIN THRESHOLD AND
PAIN INTENSITY WAS NOT
CORRELATED WITH CHANGE IN PAIN
RELIEF SO THEY SEEMED TO BE --
THERE SEEMS TO BE SOMETHING
GOING ON IN THE WAY PEOPLE ARE
MAKING A JUDGMENT ABOUT WHETHER
ALCOHOL RELIEF PAIN AT LEAST IN
THE CONTEXT WHERE THE
QUANTITATIVE CHANGES IN PEOPLE'S
PAIN SENSITIVITY ARE NOT
NECESSARILY RELATED TO THEIR
IMPRESSION OF WHETHER IT WORKED.
THAT'S SOMETHING I'M VERY
INTERESTED IN FOLLOWING UP ON.
WE ALSO FOUND EXPECTANCY PLAYED
AN IMPORTANT ROLE HERE.
THIS IS A PAPER ACCEPTED IN
CLINICAL PHARMACOLOGY, IN THE
ALCOHOL CONDITION PEOPLE WITH
GREATER EXPECTANCY OF PAIN
RELIEF FROM ALCOHOL ON THE
X-AXIS HERE REPORTED -- TENDED
TO REPORT GREATER PAIN RELIEF.
AND THIS WAS SUCH THAT A ROUGHLY
10-POINT INCREASE IN EXPECTANCY
FROM PAIN RELIEF CORRESPOND TO
5% INCREASE IN PERCEIVED RELIEF.
NOW I WANT TO TALK ABOUT THE
FUNCTIONAL NEUROCORRELATES OF
ALCOHOL ANALGESIA, MORE OF A
TEASER BECAUSE WE JUST FINISHED
COLLECTING ALL OF THE DATA FOR
NIAAA-FUNDED R01 THAT'S FOCUSED
ON THIS QUESTION, ENDED UP WITH
110 PARTICIPANTS WITH GOOD
fMRI DATA, WHICH WAS EXCITING.
63 WOMEN, ABOUT 50, 40 WHO WERE
FAMILY HISTORY POSITIVE WITHOUT
CHRONIC PAIN AND COMPLETED TWO
DOUBLE BLIND SESSIONS LIKE THE
R21.
WE USED HEAT-BASED TESTING TO
CHARACTERIZE EFFECTS OF ALCOHOL
ON THRESHOLD, INTENSITY, PAIN
RELIEF, AND RESTING STATE AND
TASKED BASEED fMRI DATA.
TODAY I'M GOING TO TALK ABOUT
RESTING STATE FINDINGS.
SO ONE OF THE AREAS WE'RE
INTERESTED IN IS LOOKING AT
FUNCTIONAL CONNECTIVITY OF THE
MEDIAL CORTICAL SYSTEM, FOCUSING
ON THE NUCLEUS ACCUMBENS,
LOOKING AT CONNECT BETWEEN THE
STRUCTURES THEY HAVE BEEN SHOWN
TO BE RELATED TO INDIVIDUALS'
ABILITY TO MODULATE PAIN AS WELL
AS VULNERABILITY TO CHRONIC PAIN
AND DEVELOPMENT OF CHRONIC PAIN
AFTER INITIAL PRESENTATION WITH
ACUTE OR SUBACUTE LOW BACK PAIN.
AND WHAT THOSE STUDIES HAVE
FOUND IS PEOPLE WITH CHRONIC LOW
BACK PAIN TEND TO HAVE HIGHER
CONNECTIVITY BETWEEN STRUCTURES
AND PEOPLE WHO ARE BETTER ABLE
TO MODULATE PAIN TEND TO HAVE
LOWER CONNECTIVITY.
WHAT WE FOUND IN OUR DATA IS
THAT THIS IS AN INITIAL SAMPLE
AND WE'RE WORKING ON ACTUALLY
REPLICATING THIS ANALYSIS NOW
WITH ALMOST OUR FULL SAMPLE THAT
ALCOHOL TENDED TO DECREASE
CONNECTIVITY BETWEEN THE
STRUCTURES ACUTELY.
IT WAS A MEDIUM TO STRONG EFFECT
BUT CONSISTENT WITH THE
POSSIBILITY THAT CHANGING
CONNECTIVITY BETWEEN
MESOCORTICAL LIMBIC CIRCUITRY IS
ONE WAY IT IS AFFECTING FOR
PEOPLE SELF-MANAGING.
WE'VE BEEN INTERESTED IN
EXPLORING NOVEL METRICS OF
RELATED TO FUNCTIONAL OR BRAIN
FUNCTION, AND ONE OF THOSE IS
REGIONAL SIGNAL VARIABILITY, YOU
MAY SEE THIS AS ALF.
OVERSIMPLIFYING IN THE INTEREST
OF TIME, GREATER SIGNAL
VARIABILITY TENDS TO BE
ASSOCIATED WITH BETTER COGNITIVE
PERFORMANCE AND BETTER PAIN
MODULATION AND REFLECTING
GREATER CAPACITY, NOT UNLIKE
HEART RATE VARIABILITY
REFLECTING GREATER ATHLETIC
CAPACITY.
WHAT WE FOUND IS ALCOHOLEL IS
ACUTELY REDUCING SIGNAL
VARIABILITY IN A VARIETY OF
CORTICAL AREAS, SO I HIGHLIGHTED
SOME HERE THAT ARE RELATED, TEND
TO BE RELATED TO DORSAL AND
VENTRAL ATTENTION NETWORKS AND
PAIN MODULATION, SO THIS COMES
FROM A PAPER PUBLISHED IN 2020
WITH INITIAL SAMPLE OF 26
INDIVIDUALS.
WE JUST RECENTLY -- THIS DATA IS
UNPUBLISHED BUT RERUN WITH THE
FULL SAMPLE, REPLICATED,
CLUSTERS BEFORE HAVE GOTTEN
LARGER, NICE TO SEE.
BUT ONE OF THE INTERESTING
FINDINGS FROM THAT INITIAL
REPORT IS THAT WE FOUND NOTHING
IN THE SUBCORTICAL AREA SO ALL
OF THE AREAS WHERE WE FOUND
ALCOHOL AFFECTING SIGNAL
VARIABILITY WAS IN THE CORTEX.
THERE WAS ALWAYS DECREASING
SIGNAL VARIABILITY.
IN THE NEW LARGER SAMPLE WE'RE
SEEING AREAS ESPECIALLY IN
SUBCORTICAL AREAS LIKE BRAINSTEM
AND THALAMUS, THAT WE'RE
INCREASING SIGNAL VARIABILITY IN
THOSE AREAS WHICH IS VERY
INTERESTING AND WE'RE LOOKING
FORWARD TO FOLLOWING UP ON THAT.
OKAY.
SO SUMMARY AND FUTURE
DIRECTIONS, OUR RESULTS ARE
PROVIDING FURTHER EVIDENCE THAT
PAIN IS PROXIMAL ANTECEDENT,
INCREASING REINFORCING EFFICACY
OF ALCOHOL AT LEAST FOR SOME
INDIVIDUALS, ESPECIALLY MEN AND
INDIVIDUALS WITH HIGHER NEGATIVE
URGENCY AND CAN ALTER THE WAY
PEOPLE ARE DRINKING IN THE FIRST
PLACE.
WE'RE ALSO FINDING THAT ALCOHOL
DOES INCREASE PAIN THRESHOLD AND
PERCEIVED PAIN RELIEF AND
DECREASED PAIN INTENSITY BUT
THERE'S SOME NUANCE WHICH IS
THAT THE EFFECTS ON PAIN RELIEF
ON GREATER THAN THRESHOLD OR
INTENSITY AND CHANGES IN RATINGS
DON'T SEEM TO BE CORRELATED WITH
PAIN INTENSITY OR PAIN
THRESHOLD.
WHICH IS SORT OF COUNTER TO THE
ASSUMPTION THE FIELD HAS MADE
FOR A LONG TIME.
SO A COUPLE THINGS WE NEED TO
FULLY CHARACTERIZE, I JUST A FEW
HIGHLIGHTS, WE NEED TO FURTHER
CHARACTERIZE PAIN AS ANTECEDENT,
IN THE CANUE MODEL AND OTHERS
AND BE CAREFUL AND INTENTIONAL
ABOUT INCLUDING INDIVIDUALS WHO
MAY BE AT HIGHER RISK FOR
ALCOHOL-RELATED CONSEQUENCES
THAT WOULD INCLUDE OLDER ADULTS,
MARGINALIZED AND PEOPLE IN
RECOVERY, SPARSELY INCLUDED IN
THESE STUDIES HISTORICALLY.
WE ALSO NEED TO RECRUITED
ADEQUATELY POWERED SAMPLES TO
TEST PREDICTIONS OF CANUE MODEL,
LOOK AT EFFECT OF SEX AND FAMILY
HISTORY ON ANALGESIC EFFECTS ON
ALCOHOL AND NEUROCORRELATES.
THAT'S ON THE WAY.
WE WANT TO STUDY MECHANISMS
UNDERLYING NEGATIVE NEGATIVE
EFFECTS, IN THE CONTEXT OF PAIN
ESPECIALLY CONSIDERING JUST HOW
ENORMOUS THE EFFECTS OF ALCOHOL
INTAKE, HOW ARE PEOPLE
DETERMINING ALCOHOL POWS PAIN
RELIEF, TO DEVELOP INTERVENTIONS
TO REDUCE.
WITH THAT I WILL TAKE ANY
QUESTIONS.
>>JEFF, BECAUSE OF THE TIME, WE
HAVE ANOTHER SPEAKER, WHAT WE'RE
GOING TO DO IF YOU CAN HANG IN
FOR 30 MINUTES, WE'LL TAKE
QUESTIONS ON BOTH TALKS AT THE
END BECAUSE WE HAVE A DISCUSSION
PERIOD.
I ALREADY HAVE A QUESTION PRIMED
UP, SO YOU WILL NOT BE
NEGLECTED.
>>SOUND GREAT.
>>I'LL GIVE A HINT LIKE I DID
YESTERDAY TO OUR SPEAKERS.
IT'S GOING TO BE ABOUT EMOTIONAL
PAIN VERSUS PHYSICAL PAIN.
>>ABSOLUTELY, YEAH.
>>CLASSIC KOOB BRAIN WANDERING.
OKAY.
NEXT SPEAKER, ARE YOU THERE, DR.
SUSAN?
>>YES.
>>SUSAN, ARE YOU THERE?
>>YES.
CAN YOU HEAR ME?
>>YES.
>>FANTASTIC.
>>FIRST OF ALL, THANKS VERY
MUCH FOR AGREEING TO SPEAK WITH
US.
HOPE WE CAN MEET IN PERSON SOON.
WE TOOK ADVANTAGE OF THE FACT WE
HAVE MEMBERS ON COUNCIL FOR BOTH
NIDA AND ALCOHOL INSTITUTE, WHAT
A GREAT OPPORTUNITY TO HEAR
ABOUT WHAT ARPA-H WITH DO AND
HOW WE CAN CREATE PARTNERSHIPS
SO WE CAN ADVANCE TRANSLATIONAL
PRODUCTS THAT ARE USEFUL FOR OUR
FIELD.
THAT'S WHY WE'RE VERY GRATEFUL
THAT YOU'RE HERE.
LET ME JUST GIVE A SHORT SUMMARY
OF DR. NONAREZ, DEPUTY DIRECTOR
FOR ARPA-H, ASSISTS IN
DEVELOPMENT OF HIGH IMPACT
HEALTH AND MEDICAL SCIENCE AND
TECHNOLOGY.
PREVIOUSLY SHE DID STRATEGY
ANALYSIS FOR ARPA-H, ACTING
DEPUTY DIRECTOR.
PRIOR TO ARPA-H, SHE WORKED IN
VARIOUS POSITIONS THROUGH
GOVERNMENT AS A FOUNDING
DIRECTOR OF THE CENTER OF
INNOVATION, IN HHS, AND EFFORTS
RELATED TO ENHANCING BIOMEDICAL
CAPABILITY IN WHITE HOUSE OFFICE
OF SCIENCE AND TECHNOLOGY POLICY
AND NATIONAL SECURITY COUNCIL.
IN ADDITION TO LEADERSHIP ROLES
IN GOVERNMENT, SHE HAS SERVED ON
ADVISORY PANELS FOR NATIONAL
ACADEMY OF SCIENCES, NATIONAL
SCIENCE ADVISORY BOARD OF
BIOSECURITY, AND FEDERAL SCIENCE
ADVISORY PANEL, AMONG OTHERS.
SHE RECEIVED A DOCTORATE IN
MICROBIOLOGY AND IMMUNOLOGY FROM
UNIVERSITY OF WISCONSIN-MADISON,
AND COMPLETED HER FELLOWSHIP
WITH AAS AND STANFORD UNIVERSITY
SCHOOL OF MEDICINE.
SUSAN, WELCOME.
>>THANK YOU SO MUCH FOR HAVING
ME.
DO YOU HAVE MY SLIDES OR DO YOU
NEED ME TO PULL THEM.
>>I HAVE THEM HERE.
IF YOU PREFER TO RUN THEM THAT'S
FINE.
>>NO, IF YOU CAN RUN THEM ALL
THE BETTER.
>>SURE.
>>I HAVE THE WRONG SCREEN AND
-- OH, PERFECT.
FANTASTIC.
THANK YOU SO MUCH.
I APPRECIATE THE TIME.
I WANT TO MAKE SURE THAT IF
THERE'S ONE THING THAT YOU LEAVE
THIS TALK WITH, IT IS THAT WE
ABSOLUTELY WANT TO MAKE SURE
WE'RE PRIORITIZING THIS
PORTFOLIO WITHIN THE WORK OF
ARPA-H.
SO I'M GOING TO GIVE YOU AN
OVERVIEW OF WHO WE ARE, WHAT
WE'RE DOING, AND SUM INTO HOW WE
SHAPE OUR PROGRAMS, AND THE
PROCESS BY WHICH WE WILL BRING
UP MANAGERS TO RUN THOSE.
IT'S IMPORTANT FOR ME TO
COMMUNICATE OUR MODEL
EFFECTIVELY SO YOU UNDERSTAND
HOW WE WOULD INCORPORATE VARIOUS
PORTFOLIO ASPECTS THAT YOU WERE
HIGHLIGHTING IN TERMS OF
ADDICTION, ADDICTION MEDICINE,
THOSE THINGS.
LET'S MAKE SURE THAT I COVER ALL
OF THAT AND HAPPY TO TAKE SOME
QUESTIONS AT THE END.
WHY DON'T WE JUMP RIGHT IN.
NEXT SLIDE.
SO, FIRST THING, WE'RE COMMITTED
TO WORKING WITH OUR PARTNERS AT
NIH.
WE'RE PART OF NIH.
WE ARE A SEPARATE INDEPENDENT
AGENCY BUT FULLY RECOGNIZE THAT
WE HAVE SUCH GREAT COLLEAGUES
AND TECHNICAL EXPERTISE DERIVED
FROM OUR SISTER AGENCY
INSTITUTES.
I'LL TALK ABOUT THAT, I'LL GIVE
OVERVIEW OF THE MISSION, HOW WE
THINK ABOUT OURSELVES, TALK
EXTENSIVELY ABOUT OUR BUSINESS
MODELS AND THEN MORE ABOUT SOME
SORT OF ADMINISTRATIVE
ACTIVITIES IN TERMS OF HUB AND
SPOKE MODEL TO CREATE A DATA
COMMONS, TALK ABOUT PROGRAM
MANAGERS AND CLOSE BY GIVING YOU
SOME SENSE OF OUR INITIAL KEY
INITIATIVES THAT WE'RE WORKING
ON.
NEXT SLIDE PLEASE.
WE THINK OF OURSELVES AS NIH'S
NEWEST PARTNER.
WE'RE REALLY COMMITTED TO
WORKING TOGETHER WITH OUR
COLLEAGUES AT NIH.
NEXT SLIDE.
SO WE THINK ABOUT THIS AS A
COLLABORATION ACROSS THE
ENTIRETY OF THE PROGRAM LIFE
CYCLE.
WHEN WE THINK ABOUT OUR PROGRAMS
AND ARE DESIGNING OUR PROGRAMS
WE WANT TO WORK WITH OUR NIH
COLLEAGUES, SUBJECT MATTER
EXPERTED TO ENSURE WE'RE
VALIDATING THESE WELL-DEFINED
PROBLEMS IN HEALTH.
WE WANT TO MAKE SURE WE'RE
SHARING OUR CONCEPTS
APPROPRIATELY WITH OUR
COLLEAGUES AT NIH TO ENSURE
WE'RE VALIDATING THE EFFORTS ARE
NOT REDUNDANT.
THEY SHOULD BE COMPLEMENTARY, IF
POSSIBLE.
AND WE THINK ABOUT THESE AS
ARPA-H HARD, WE'RE WILLING TO
TAKE ON HIGH RISK, HIGH REWARD
ASPECTS OF A PROBLEM SET THAT
MAY EXTEND THE WAY NIH WOULD BE
TRADITIONALLY THINKING ABOUT HOW
WE WOULD ADDRESS A PARTICULAR
HEALTH CARE CHALLENGE.
WE WORK IN A BOTTOM UP APPROACH.
WE HAVE A SINGLE PROGRAM MANAGER
WHO OVERSEES THE PROGRAM BUT WE
BUILD A ROBUST PERFORMER TEAM TO
HELP SUPPORT THE DEVELOPMENT OF
WHATEVER THAT PARTICULAR PRODUCT
OR PROCESS OR POLICY, WHATEVER
IT IS THAT WE'RE SEEKING TO
ACHIEVE THROUGH OUR INITIATIVE.
BUT WE WANT TO -- NIH SME, TO
HAVE, YOU KNOW, FOLKS IN THEIR
COMMUNITIES THAT WOULD BE GREAT
TO BE ON OUR PERFORMER TEAMS.
WE ENCOURAGE NIH COLLEAGUES TO
ACTUALLY SHARE WITH THE R&D
NETWORKS TO HELP MAKE SURE WE
HAVE THE BEST PERFORMER TEAMS
OUT THERE.
AND WE ALSO WILL HAVE OUR NIH
SUBJECT MATTER COLLEAGUES
SUPPORT PROPOSAL EVALUATION TO
HOLD OURSELVES TO A HIGH
STANDARD AS WE LAUNCH THESE
REALLY BIG AND FORWARD-LEANING
PROGRAMS.
AND THEN HELPING -- BRINGING
COLLEAGUES ON TO HELP US --
ENSURING WE'RE EXECUTING AND
MEASURING PROGRESS ASSOCIATED
WITH OUR PROGRAMS, ESSENTIALLY
FROM DAY 1, SO WE'RE DESIGNING
THE RIGHT MILESTONES AND METRICS
SO WE CAN MITIGATE RISK OF
HIGH-RISK, HIGH-REWARD PROGRAMS
BUT HOLDING PERFORMERS
ACCOUNTABLE TO CRITICAL
STANDARDS THERE ARE DERIVED FROM
SUBJECT MATTER EXPERTS.
AND LEARNING AND GROWING MAKING
SURE OUR NIH COLLEAGUES ARE
INVOLVED IN OUR PROGRAMS, THEY
MAY BE TRANSITION PARTNERS, MAY
BE IN TERMS OF DATA WE'RE
DERIVING, MAY COMBINE DATA
FUNDED OUT OF NIH WITH DATA THAT
IS DERIVED FROM OUR PROGRAMS TO
CREATE SOMETHING THAT HELPS
SUPPORT AN ENTIRELY DIFFERENT
WAY.
WE THINK OF NIH AS STAKEHOLDERS
THROUGHOUT THE DURATION OF OUR
PROGRAMS AND FINALLY
COMMERCIALIZATION AND
TRANSITION, WANT TO MAKE SURE
THAT NIH STAKEHOLDERS
APPROPRIATE FOR TECH TRANSITION
ARE ALSO USERS AND FUNDERS SO WE
THINK ABOUT THEM AS PART OF THE
HOLISTIC LIFE CYCLE.
THEN HELPING TO CONSIDER IF
WE'RE STARTING SOMETHING THAT IS
HIGH RISK, BUT APPROPRIATE FOR
SUCCESSFUL TRANSITION INTO NIH
THINKING OF NIH AS POTENTIAL
TRANSITION PARTNER.
SO THAT'S HOW WE'RE WORKING
DIRECTLY WITH OUR COLLEAGUES AT
NIH.
IF YOU COULD GO TO THE NEXT
SLIDE.
SO WE'VE BEEN OPERATIONALIZING
OUR COMMITMENT TO WORKING WITH
VARIOUS PARTNERS ACROSS NIH SO
YOU'LL SEE MY BOSS WORKING WITH
LEADERSHIP AND WE CONTINUE TO
LOOK FORWARD TO ADDITIONAL
OPPORTUNITIES TO COLLABORATE AT
THE SENIOR LEADERSHIP AS WELL AS
PROGRAM MANAGER AND OTHER STAFF
LEVEL.
NEXT SLIDE.
REINFORCING WE SEE OURSELVES
HAVING MANY FUTURE
COLLABORATIONS WITH OUR
COLLEAGUES WITHIN NIH AND
HOPEFULLY NIDA AND OTHERS WILL
BE JOINING US AS PART OF THE
COLLABORATIVE ORGANIZATION,
COLLABORATIVE GROUP, LOOK
FORWARD TO CONTINUING OUR
DISCUSSIONS AFTER THIS MEETING
AND MANY OTHERS.
GO TO THE NEXT SLIDE.
WHEN IT COMES TO OUR
ORGANIZATION, WHEN YOU ARE GIVEN
TO SOLVING THE CHALLENGES, IT'S
DAUNTING.
ONE THING WE DID EARLY ON WAS TO
TRY TO PARSE THAT ACROSS FOUR
MAJOR FOCUS AREAS, AND SO WHERE
WE ENDED UP LANDING IS THE FOUR
YOU SEE IN FRONT OF YOU.
HEALTH SCIENCE FUTURES, SCALABLE
SOLUTIONS, PRO-ACTIVE HEALTH AND
RESILIENT SYSTEMS.
HEALTH SCIENCE FUTURE IS THE
FAR-OFF VISION FOR WHAT THE
FUTURE OF HEALTH SCIENCE COULD
LOOK LIKE.
IT'S REALLY DESIGNING, YOU KNOW,
OVER THE HORIZON PLATFORMS,
NOVEL APPROACHES TO VARIOUS
HEALTH CARE CHALLENGES OR HEALTH
SCIENCE CHALLENGES THAT ARE,
AGAIN, POSITIONING VERY HIGH
RISK BECAUSE THERE'S SO MUCH
UNCERTAINTY THAT WE TAKE ON AS
WE'RE DEVELOPING THOSE VARIOUS
MECHANISMS OF PLATFORM
TECHNOLOGY DEVELOPMENT AND WHAT
NOT.
SO THAT'S WHERE WE ARE.
WHEN YOU'RE THINKING ABOUT THE
PORTFOLIO HOLISTICALLY THIS IS
WHERE YOU WOULD POSITION THE
EARLIEST TYPE DEVELOPMENT OF
PLATFORM AND TECHNOLOGIES AND
HELD SCIENCE FUTURES.
THE OTHER THREE SCALABLE
SOLUTIONS ARE CLOSER TOWARDS
TRADITIONAL PRODUCT DEVELOPMENT
AND TECH TRANSFER.
SCALABLE SOLUTIONS IS THINKING
ABOUT IF WE HAVE A SOLUTION THAT
WORKS FOR A LIMITED POPULATION,
YOU KNOW, SMALL NUMBER OF
INDIVIDUALS, AND IS HELD BACK
FOR TECHNICAL REASONS, COST
REASONS, LOGISTICAL REASONS,
ANYTHING THAT PREVENTS IT FROM
SCALING TO THE BROADEST SET OF
POPULATION THAT WOULD BENEFIT,
THAT'S WHERE SCALABLE SOLUTIONS
COME IN, MAKING SURE THAT HEALTH
BENEFITS ARE REACHING EVERYONE.
COLLECTIVE HEALTH IS ENSURING WE
CREATE TECHNOLOGIES THAT KEEP
INDIVIDUALS FROM BECOMING
PATIENTS.
OR IF THEY ARE PATIENTS, WE
ALLOW THEM TO NOT PROGRESS DOWN
THE DISEASE PATHWAY OR HAVE
OPPORTUNITY TO HAVE THE BEST
OUTCOMES AND WELLNESS ASSOCIATED
WITH WHATEVER CONDITION OR
HEALTH CHALLENGE THAT THEY FACE.
IT'S ABOUT HELPING US ALL THEY
INDIVIDUAL LEVEL OR COMMUNITY
LEVEL HAVE INCREASED HEALTH AND
WELLNESS.
RESILIENT SYSTEMS, WE UNDERSTAND
THERE ARE PERTURBATIONS IN THE
HEALTH ECOSYSTEM, WHETHER FROM
EXTERNAL SOURCES LIKE CLIMATE
CHANGE OR CYBERSECURITY, HEALTH
DATA SECURITY ISSUES OR ANY
ASPECT OF HEALTH ECOSYSTEM
THAT'S BEEN CHALLENGED WHETHER
IN COVID OR OTHER AREAS, THIS
OFFICE IS THINKING HOW DO WE
ENSURE THAT WE CREATE A MORE
RESILIENT HEALTH ECOSYSTEM.
WE HAVE ADDITIONAL TOPICS OF
INTERESTS, QUANTITATIVE MEASURES
OF HEALTH OUTCOMES, AS WE AS
ARPA-H AGENCY MAKE INVESTMENT IN
HEALTH ECOSYSTEM WHAT DOES
SUCCESS LOOK LIKE?
HOW DO WE ENSURE THAT THE
LIMITED RESOURCES WE HAVE
AVAILABLE TO US AND HIGH-RISK,
HIGH-REWARD PROGRAMS WE WANT TO
POSITION AND LAUNCH WHAT IS
DERIVED BENEFIT WE WOULD BE ABLE
TO SAY WE HAVE NOW HELPED
SUPPORT THIS TANGIBLE
QUANTITATIVE OUTCOME WITHIN THE
HEALTH ECOSYSTEM?
THAT'S IN THE LONG RUN.
WE'RE ALSO THINKING ABOUT HOW TO
WE HAVE SOME INTERIM
QUANTITATIVE MEASURES THAT WOULD
HELP US SUPPORT PROGRAM DESIGN.
WHAT DO WE CURRENTLY UNDERSTAND
ABOUT THE NUMBER OF INDIVIDUALS
WHO HAVE THIS PARTICULAR
DISEASE?
OR WHETHER THIS TECHNOLOGY NEEDS
TO BE DESIGNED IN A CERTAIN
ASPECTS OR ANOTHER BECAUSE OF
QUANTITATIVE MEASURES OF HEALTH
OUTCOMES, TAKING A DATA FORWARD
QUANTITATIVE APPROACH TO
ORGANIZATIONAL DESIGN AND
PROGRAM DESIGN.
WE ALSO ARE TAKING A HUMAN
CENTERED DESIGN FOR HEALTH
INNOVATIONS, MAKING SURE THAT AS
WE BUILD OUT TECHNOLOGIES, THEY
ARE THE ONES THAT PEOPLE WILL
USE THAT CLINICIANS CAN
INCORPORATE INTO WORKFLOWS, THAT
THE BROADER POPULATION WILL WANT
TO TAKE INTO THEIR HOMES, THAT
WILL LEAD TO BETTER HEALTH
OUTCOMES.
SO IT'S VERY MUCH A
HUMAN-CENTERED DESIGN APPROACH.
PARTICIPATORY RESEARCH, WE WANT
TO MAKE SURE THE VOICES AND TO
THE EXTENT IT'S APPROPRIATE
PATIENTS ARE BEING REFLECTED IN
OUR RESEARCH.
AND SO HOW DO WE ENSURE THAT WE
HAVE A REALLY STRONG APPROACH TO
INCENTIVIZING A RESPECTFUL
PARTICIPATION OF OUR PATIENT
POPULATIONS, PROVIDER
COMMUNITIES IN OUR RESEARCH
APPROACHES.
THE LAST THING WE FULLY
RECOGNIZE THAT WORKING AT THE
FAR END OF THE INNOVATION
SPECTRUM WE'RE PUSHING WHAT IS
UNDERSTOOD ABOUT THE
IMPLICATIONS ABOUT TECHNOLOGY SO
WE'RE BUILDING INTO EVERYTHING
WE DO WHAT WE CALL ELSI, SIMILAR
TO WHAT THE HUMAN GENOME PROJECT
ENDED UP HAVING TO CONSIDER, AS
IT WAS BEING BUILT OUT, WE
UNDERSTAND THERE ARE
IMPLICATIONS ASSOCIATED WITH
THAT.
WE'RE BUILDING THAT IN FROM DAY
1 AND WE'LL BE WORKING VERY
QUICKLY TO LAUNCH OUR PUBLIC
APPROACH TO ELSI AND THEN EVERY
PROGRAM THAT WE BUILD OUT WILL
HAVE ELSI REVIEW AND ELSI
ACTIVITIES ASSOCIATED WITH IT.
I CAN TALK MORE ABOUT ANY OF
THOSE.
NEXT SLIDE.
SO HOPEFULLY -- I WON'T GO INTO
DETAIL, HOPEFULLY THEY ARE MADE
AVAILABLE BECAUSE IT GOES INTO
ADDITIONAL DEPTH, EACH ONE OF
THE FOCUS AREAS I TALKED ABOUT,
SO THIS ONE IS HEALTH SCIENCE
FUTURES, AGAIN ABOUT WHAT'S
TECHNICALLY POSSIBLE, INNOVATIVE
TOOLS, TECHNOLOGIES, PLATFORMS
THAT ALLOW US TO THINK ABOUT
MODULATION OF HOST SYSTEMS,
DELIVERY OF TARGETS, TEMPORAL,
SPATIAL PRECISION AS WELL AS
MITIGATION OF OFF-TARGET EFFECTS
TO ACCELERATE INTERVENTIONS,
THINKING ABOUT WHAT THE OVER THE
HORIZON HEALTH SCIENCES THAT THE
FUTURE THAT WE CAN CREATE
THROUGH OUR PROGRAMS.
NEXT SLIDE PLEASE.
AND SCALABLE SOLUTIONS, WHERE WE
ARE CONSIDERING HEALTH CARE
ACCESS AND AFFORDABILITY, MAKING
SURE SOMETHING THAT IS AVAILABLE
TO A SMALL NUMBER OF INDIVIDUALS
THAT WE CAN ACTUALLY REACH THE
FULL BREADTH OF THOSE WHO WOULD
BENEFIT ACROSS DEMOGRAPHICS,
GEOGRAPHY, RESOURCES, EARLY ONCE
ARE HISTOPATHOLOGY, RARE DISEASE
DIAGNOSIS AND TREATMENT, AND
SURGICAL INTERVENTIONS AND SO
THOSE ARE SOME AREAS WE'RE
STARTING TO THINK ABOUT BUT WANT
TO MAKE SURE THAT WE CAN HELP
SUPPORT A BROAD SCALABLE IMPACT
OF ALL HEALTH INNOVATION.
NEXT SLIDE PLEASE.
PRO-ACTIVE HEALTH, KEEPING
PEOPLE FROM BECOMING PATIENTS,
SO IMPROVING HEALTH AND
WELLNESS, REALLY TRYING TO MAKE
SURE WE TAKE A VERY PRO-ACTIVE
INNOVATIVE APPROACH TO
SUPPORTING TECHNOLOGIES THAT CAN
KEEP INDIVIDUALS OR COMMUNITIES
OR POPULATION HEALTHIER, WHETHER
ROBOTICS, WEARABLES, OTHER
DEVICES, HELPING TO THINK
THROUGH WHO WOULD BENEFIT, AGING
POPULATION, COGNITIVE OR
MOVEMENT DISORDERS, HELPING
PEOPLE AGE IN PLACE, ALL THE
THINGS THAT WE'RE TRYING TO
INCORPORATE.
SO WE'RE LOOKING AT WHAT ARE THE
TECHNOLOGIES THAT COULD BE
HELPFUL, HOW DO WE ACCELERATE
RECOVERY, ENHANCE IMMUNE
FUNCTIONS, IMPROVING MENTAL
HEALTH, TREATING SLEEP
DISORDERS, THINKING ABOUT WHAT
IS NEW IN THIS AREA THAT WE CAN
BE INVESTING IN THAT'S
TRANSFORMATIONAL.
NEXT SLIDE PLEASE.
AND RESILIENCE SYSTEMS.
AS I SAID, UNDERSTANDING WHAT
ARE THE BLOCKERS FOR HAVING A
STABLE AND RELIABLE HEALTH
ECOSYSTEM THAT ALLOWS US TO
WEATHER THE CRISIS, ARPA-H
HAVING THE OPPORTUNITY TO
INNOVATE FROM THE MOLECULAR TO
SOCIETAL LEVELS, AND SO WE'RE
THINKING ABOUT ENTIRE SPECTRUM
WHERE WE COULD PUT ACTIVITIES IN
PLACE TO ADDRESS FUTURE
PANDEMICS, SOCIAL DISRUPTION,
CLIMATE CHANGE, MOLECULAR
DISTURBANCES, ECONOMIC
DISABILITY, AND MANY OTHERS.
AND SO REALLY THINKING, YOU
KNOW, WHAT DO WE DO TO MAKE SURE
WE'RE ADDRESSING THESE
CHALLENGES, USING NOVEL METHODS,
USING INNOVATIVE APPROACHES,
THINGS THAT REALLY CAN BE
TERRIFICALLY TRANSFORMATIONAL,
AND SOMEONE COULD SAY, OKAY, NOW
WE CAN DO BETTER NEXT TIME THIS
HAPPENS WHICH INVARIABLY IT WILL
BECAUSE WE NOW HAVE THIS
CAPABILITY IN PLACE.
NEXT SLIDE.
ONE EXAMPLE OF WHAT WE'RE
THINKING ABOUT BEFORE WE LAUNCH
ANY PROGRAMS, WE GET LOTS OF
QUESTIONS, SHOW US WHAT A
PROGRAM WOULD LOOK LIKE.
HERE IS A NOTIONAL EXAMPLE OF
DIGITAL HISTOPATHOLOGY
CAPABILITY WE WOULD POTENTIALLY
SUPPORT OUT OF ARPA-H.
WE'RE ALIGNED WITH THE
ADMINISTRATION CANCER MOONSHOT,
CANCER PRIORITIES WILL BE
CROSS-CUTTING.
THE PROGRAM PROBLEM WHEN WE TALK
ABOUT THE BIG CHALLENGES THAT
WE'RE SEEKING TO ADDRESS, WE
KNOW CURRENT HISTOPATHOLOGY
PRACTICES ARE MANUAL, REQUIRE
EXPERT IN THE LOOP, QUITE OFTEN
COSTLY, AND THE DATA IS NOT
ACCESSIBLE TO SHARE BROAD
INSIGHTS TO IMPROVE PATIENT
CARE.
SO WHEN WE THINK ABOUT LET'S
BREAK THAT DOWN INTO ALL THE
DIFFERENT SUBPROBLEMS ASSOCIATED
WITH THAT PROBLEM STATEMENT AND
COMING UP WITH APPROACH THAT
WOULD ALLOW US TO ADDRESS THAT
IN A REALLY SORT OF -- THE
BOLDEST MOST AMBITIOUS MOST
PRACTICAL WAY POSSIBLE, DESIGN
AND DEVELOP NOVEL MULTIOMIC
HISTOPATH ASSAYS THAT ARE
SUPPORTED THROUGH AI/ML FOR
DIAGNOSTICS AND
CHARACTERIZATION, AND DATA
INTEGRATION INTO CARE PATHWAYS
SO WE REMOVE THE BARRIERS TO
HAVING A SEAMLESS END TO END
SOLUTION TO WHAT'S CURRENTLY
BLOCKING IMPROVED CANCER
DIAGNOSIS AND DATA INSIGHTS AND
DATA INFORMATION SHARING.
THEN LOOKING AT WHAT WOULD WE
DO?
WE LOOK FOR APPLICATIONS AND
INDICATIONS THAT WOULD INCLUDE
PROOFS OF CONCEPT FOR METASTATIC
CANCERS, NEURODEGENERATIVE
DISEASES, WOUND HEALING.
SO EVEN BEYOND JUST A SINGLE
SORT OF DISEASE STATE THAT WE
WOULD BE THINKING, OKAY, THIS
WOULD SOLVE FOR CANCER, IF THE
APPROACH THAT WE WOULD DESIGN
OUT OF OUR PROGRAMS WOULD ALSO
EXTEND TO OTHER INDICATIONS LIKE
NEURODEGENERATIVE DISEASES, OR
WOUND HEALING, THEN IT WOULD
ALLOW US TO CREATE THESE STRONG
PLATFORMS THAT ARE ACTUALLY SORT
OF MORE APPROPRIATELY POSITIONED
TO HAVE TRANSFORMATIVE IMPACT ON
THE HEALTH ECOSYSTEM THAN
SOMETHING MORE LIMITED TO ONE
INDICATION OR SOLVING ONE SINGLE
PROBLEM WITHIN THE HEALTH
ECOSYSTEM.
NEXT SLIDE PLEASE.
LET ME TALK A LITTLE ABOUT OUR
MISSION AND BUSINESS MODEL.
NEXT SLIDE PLEASE.
WE'RE THINKING ABOUT
ACCELERATING BETTER HEALTH
OUTCOMES FOR EVERYONE.
WHEN WE ANCHOR OUR APPROACH TO
EVERYTHING THAT WE DO, WE
CHALLENGE OURSELVES TO NOT JUST
DEVELOP CAPABILITIES THAT
PROMISE TO DELIVER BETTER HEALTH
OUTCOMES FOR A SUBSET OF THE
POPULATION.
WE WANT TO MAKE SURE THAT WE ARE
IN ALIGNMENT WITH THIS
ADMINISTRATION'S PRIORITIES TO
HAVE HEALTH EQUITY AND INCLUSION
ACROSS ALL POPULATIONS AND SO AS
WE'RE SEEING PROGRAMS OR
PROJECTS THAT ARE COMING IN, OUR
FIRST QUESTION IS WHO BENEFITS.
AND HOW DO WE MAKE SURE THAT
ANYTHING THAT WE SUPPORT THROUGH
ARPA-H CAN TOUCH EVERYONE WHO
HAS THAT PARTICULAR CHALLENGE
WITHIN THE HEALTH ECOSYSTEM AND
COULD BENEFIT FROM A PROGRAM
FROM ARPA-H SO IT'S REALLY WHAT
WE'RE PUSHING FOR.
THAT IS THE PROMISE OF OUR
AGENCY.
NEXT SLIDE PLEASE.
WE'VE BEEN INCREDIBLY FORTUNATE
THIS ADMINISTRATION HAS BEEN SO
SUPPORTIVE ABOUT HEALTH
INNOVATION.
PRESIDENT BIDEN WHEN HE LAUNCHED
ARPA-H HE WAS SO CLEAR ABOUT
ARPA-H, YOU KNOW, WE'LL BREAK
THE MOLD HOW WE SUPPORT
FUNDAMENTAL RESEARCH AND
COMMERCIAL PROJECTS IN THIS
COUNTRY SETTING THE BAR THAT THE
IDEAS WOULD BE SO AUDACIOUS THAT
THEY MAY WORK, THEY MIGHT WORK,
BUT THEY ARE WIN THE HIGH RISK,
HIGH REWARD PARADIGM, AT THAT
TIMES -- AND THAT'S WHAT ARPA-H
IS POSITIONED TO TAKE ON.
INCREMENTAL IMPROVEMENTS IS NOT
HOW WE'RE GOING TO BE CONDUCTING
BUSINESS.
WE'RE REALLY GOING TO TAKE OUR
AGENCY AND PUSH OURSELVES TO THE
VERY FAR END OF THE HEALTH
INNOVATION CONTINUUM AND THAT'S
WHERE WE'RE GOING TO LAUNCH OUR
PROGRAMS.
SO WE'RE VERY FORTUNATE TO HAVE
SUCH STRONG SUPPORT FROM THIS
ADMINISTRATION, FROM THE WHITE
HOUSE, AND THEY ARE CONTINUING
TO DO SO, SO WE'RE VERY
APPRECIATIVE OF THAT.
NEXT SLIDE PLEASE.
WE HOLD OURSELVES ACCOUNTABLE.
ONE OF THE THINGS WE HAVE DONE
WITHIN THE SPACE THAT WE ARE
WORKING OUT OF, AND ALL OF OUR
SORT OF PERSONAL DEVICES, WE
HOLD OURSELVES ACCOUNTABLE TO
IMAGINE IF CHALLENGES.
WE HAVE GREAT POSTERS THAT ARE
ALL AROUND US.
YOU CAN GO TO OUR WEBSITE AND
HAVE THEM YOURSELF.
WHAT IF WE COULD DESIGN
AFFORDABLE CUSTOM CAN CER
VACCINES FOR EVERYONE?
WE CAN DO IT FOR A SMALL NUMBER
OF INDIVIDUALS, INCREDIBLY
COSTLY.
WHAT IF EVERYBODY COULD HAVE A
CUSTOM CANCER VACCINE WHO NEEDS
IT?
AND IT'S AFFORDABLE TO EVERYONE.
WHAT IF WE COULD DO 3D
BIOPRINTED REPLACEMENTS FOR
DAMAGE THE ORGANS?
RIGHT NOW WE HAVE ORGAN DONATION
SYSTEM IN THE UNITED STATES,
WHAT IF WE COULD BE SO
DISRUPTIVE BY CREATING ORGANS
THAT ARE COMPATIBLE WITH THE
INDIVIDUAL WHO NEEDS THEM AND
DON'T HAVE TO RELY ON THE SYSTEM
WE CURRENTLY HAVE IN PLACE?
WHAT IF WE COULD DO NANOROBOTIC
SURGERY DELIVERED BY A PILL?
RIGHT NOW THERE ARE SO MANY
IMPEDIMENTS AND CHALLENGES TO
THE CURRENT WAY WE TREAT
DISEASES, ESPECIALLY THOSE WHO
NEED SURGERY, WHAT IF WE COULD
DO SOMETHING ENTIRELY DIFFERENT
THAT REDUCED MORBIDITY AND
MORTALITY AND EVERYTHING ELSE
ASSOCIATED WITH SURGERY,
REQUIRED SURGERY?
AND THESE ARE NOT SCIENCE
FICTION.
WE'RE GETTING READY TO WORK
ACROSS ALL OF THESE AND MANY
MORE.
AND THAT IS THE BAR THAT WE'RE
SETTING FOR OURSELVES.
NEXT SLIDE.
WE HAVEN'T BEEN AROUND VERY
LONG.
IT WAS JUST OVER A YEAR AGO,
MARCH 15 OF 2022, WHEN WE CAME
INTO EXISTENCE.
DR. WEGRSZYN WAS SWORN IN
OCTOBER 11.
SWEEL BRAT - WE CELEBRATED OUR
FIRST BIRTHDAY.
EVERYONE IS ENERGIZED TO START
TO MAKE THE TYPE OF IMPACT WE
KNOW WE WANT TO MAKE.
DR.ER WITHING REPORTS TO THE
SECRETARY.
WE PARTNER SO CLOSELY WITH
SUBJECT MATTER EXPERTS AND
INCREDIBLE TALENT AT NIH SO WE
CHERISH THAT RELATIONSHIP AND WE
WANT TO MAKE SURE THAT WE WORK
CLOSELY WITH OUR COLLEAGUES AT
NIH, AND WE HAVE OUR PROGRAM
MANAGERS AND BUSINESS TEAM
MEMBERS.
WE'VE BEEN FORTUNATE, CONGRESS
PROVIDED $2.5 BILLION TO GET US
OFF THE GROUND.
WE TAKE THAT SERIOUSLY, THE
OBLIGATION TO USE EVERY PENNY IN
THE MOST EFFECTIVE WAY TO CREATE
THOSE CAPABILITIES THAT WE'VE
BEEN TALKING ABOUT.
WE DON'T HAVE INTERNAL RESEARCH
LABS, THAT'S NOT HOW WE WORK,
AND WE'RE DISEASE AGNOSTIC,
LOOKING FOR BIG IDEAS THAT CUT
ACROSS MULTIPLE CONDITIONS TO BE
ABLE TO CREATE THESE PLATFORMS,
THESE PARADIGM CHANGES IN THE
HEALTH ECOSYSTEM.
WE HAVE A LEAN AND NIMBLE
MANAGEMENT STRUCTURE.
WE WANT THE MAJORITY OF OUR
FUNDINGS TO GO OUT TO
PERFORMERS, INTO THE ECOSYSTEM,
NOT TO STAY WITHIN THE AGENCY.
WE'RE A BOTTOM-UP AGENCY.
WE HAVE PRIZE AUTHORITY.
WE'VE LAUNCHED OUR FIRST PRIZE
COMPETITION, NEARING COMPLETION,
I'LL TALK MORE ABOUT THAT.
WE'RE NOT GRANTS BASED.
WE DO NOT ISSUE GRANTS.
WE FOCUS ON COOPERATIVE
AGREEMENTS, OTHER TRANSACTIONS
AND CONTRACTS.
FINALLY WE DO THIS HIGH
RISK/HIGH IMPACT RESEARCH,
THINGS THAT, AGAIN, IN PRESIDENT
BIDEN'S VISION IT'S SO AUDACIOUS
THAT IT MIGHT WORK, JUST MIGHT
WORK.
WE'RE REALLY WILLING TO TAKE ON
THAT HIGH RISK PORTFOLIO.
NEXT SLIDE PLEASE.
AND WE ARE NOT ALONE IN THE
HEALTH ECOSYSTEM.
WE HAVE PARTNERS FROM ACROSS THE
STAKEHOLDER GROUPS, INSIDE AND
OUTSIDE OF GOVERNMENT.
AND WE'RE RUNNING SHORT ON TIME
SO I DON'T WANT TO GET INTO
DETAIL HERE BUT WE HAVE
RESPECTFUL APPRECIATION FOR
EVERY PART OF THE ECOSYSTEM, AND
EVERY PART WILL HAVE AN INPUT OR
OUTPUT OR OUTCOMES FROM ARPA-H
AND WE INTEND TO ENSURE WE WORK
TIRELESSLY ACROSS THE ECOSYSTEM.
NEXT SLIDE PLEASE.
WE'RE OPEN FOR BUSINESS.
SO WE LAUNCHED OUR FIRST BROAD
AGENCY ANNOUNCEMENT A LITTLE
WHILE AGO, A FEW MONTHS, ABOUT A
MONTH AND A HALF AGO.
AND WE'RE ACTIVELY SEEKING
REALLY AMBITIOUS PROJECTS,
THINGS THAT, YOU KNOW, THAT ARE
SO BOLD THAT REALLY NO OTHER
AGENCY WOULD FUND THEM BECAUSE
THEY ARE SO SORT OF AMBITIOUS
AND SO FORWARD LEANING, SO JUST
THINKING ABOUT PROBLEMS IN AN
ENTIRELY DIFFERENT WAY, ACTIVELY
LOOKING AT THOSE PROPOSALS TO
COME IN, AND SO IF YOU OR ANYONE
YOU KNOW HAS A BIG BOLD IDEA,
PLEASE FEEL FREE TO PUT IN AN
APPLICATION.
WE'VE LOWERED THE THRESHOLD, A
3-PAGE ABSTRACT, REQUIREMENTS
ARE ON OUR WEBSITE.
YOU CAN SEE ALL THE OTHER
REQUIREMENTS.
BE BOLD.
BE AMBITIOUS, SUBMIT YOUR IDEAS.
SITE SELECTION, MULTIPLE
LOCATIONS, CONGRESS REQUIRED US
TO HAVE THREE SITES SO WE'RE
CREATE BE A HUB AND SPOKE MODEL,
WE'LL EXTEND OUR REACH AND
PARTNERSHIPS AND YOU CAN FIND
MORE INFORMATION ABOUT THAT AND
THE ARPA-H DASH, OUR FIRST
CHALLENGE.
IT WAS THE DASH TO IMPROVE
HEALTH OUTCOMES, JUST A REALLY
FUN WAY TO REACH OUT TO THE
BROADEST STAKEHOLDER COMMUNITY
POSSIBLE TO ANNOUNCE WE WERE
HERE.
WE'VE HAD TENS OF THOUSANDS OF
INDIVIDUALS PARTICIPATE OR HAVE
A BETTER UNDERSTANDING WHAT
ARPA-H IS, DUE TO THIS
COMPETITION, A BRACKET CHALLENGE
SIMILAR TO ANOTHER FAMOUS
CHALLENGE THAT HAPPENS IN MARCH
THAT STARTS WITH 64, ENDS WITH
1, OVER SIX SETS OF WEEKS.
WE'RE HEAD TO HEAD COMPETITION
ALLOWS US TO SEE MOST INNOVATIVE
IDEAS BASED ON VOTING.
WE LOOK INTERNALLY AS WELL FOR
FINAL CONFIRMATION.
THAT CONTEST WILL END NEXT
MONDAY.
WE WILL ANNOUNCE THE WINNER NEXT
WEEK, LATER NEXT WEEK.
BUT IF YOU'RE INTERESTED IN WHO
IS CURRENTLY IN THE FINAL FOUR,
WE'RE AT THE FINAL FOUR, YOU CAN
VOTE TODAY, AND WE'LL ANNOUNCE
THE FINAL TWO I BELIEVE TOMORROW
OR ON FRIDAY.
WE WILL DO MORE COMPETITIONS AS
WE CONTINUE TO GO.
ALL RIGHT.
I THINK THAT'S ALL I HAVE TIME
FOR.
WHY DON'T I STOP THERE.
I COVERED ALMOST EVERYTHING ELSE
IN THE SLIDES, HAPPY TO ANSWER
ANY QUESTIONS THAT ANYONE MAY
HAVE ABOUT ARPA-H, OUR BUSINESS
MODEL, WHAT WE'RE THINKING, HOW
YOU CAN WORK WITH US OR ANYTHING
ELSE THAT WOULD BE HELPFUL.
I REALLY APPRECIATE THE
OPPORTUNITY TO MEET WITH ALL OF
YOU TODAY.
>>THANKS VERY MUCH.
A WONDERFUL PRESENTATION.
NOW WE'RE OPENING UP FOR
QUESTIONS.
WE'RE OPENING UP FOR YOUR
PRESENTATION AND DR.
BOISSONEAULT.
JUST FOR CLARIFICATION, I DIDN'T
REALLY GET IT IN MY BRAIN,
YOU'RE GOING TO BE SELECTING
PROJECTS THAT ARE MERITORIOUS
BUT IF IT'S GOING TO BE BASED ON
A VOTING SYSTEM OR HOW IS THAT
SELECTION MADE?
WHO ARE THE PEOPLE THAT ARE
GOING TO BE MAKING THAT
DECISION?
>>SUCH A GOOD QUESTION.
I RAN OUT OF TIME.
I WAS JUST ABOUT TO TELL YOU
ASPECTS OF OUR BUSINESS PROCESS.
WE'RE A PROGRAM MANAGER DRIVEN
ORGANIZATION, UNIQUELY
POSITIONED IN GOVERNMENT,
SIMILAR TO THE WAY DARPA RUNS
ITS PORTFOLIO.
WE DON'T HAVE REQUIREMENTS FROM
THE OUTSIDE.
WE RECRUIT HIGHLY TALENTED VERY
PASSIONATE PROGRAM MANAGERS,
INDIVIDUALS, WHO COME IN WITH AN
IDEA, AND THEY ESSENTIALLY USE
THE HEIDELMEYER QUESTIONS,
CHALLENGING QUESTIONS THAT
REQUIRE TECHNICAL UNDERSTANDING
ABOUT THE PROGRAM.
SETS A HIGH BAR.
WHAT A PROGRAM MANAGER HAS TO DO
TO GET A PROGRAM FUNDED.
WE HAVE AN INTERNAL SUBJECT
MATTER EXPERT SORT OF VALIDATION
APPROACH WHERE THE PROGRAM
MANAGER SAYS I WANT TO DO THIS
PROGRAM, AND THEY MEET OUR
STANDARDS FOR CREATING WHAT THAT
PROGRAM WILL BE AND INTERNALLY
VET, VALIDATE, ULTIMATELY DR. WG
ER WITHING -- DR. WERGRYZN HAS
FINAL AUTHORITY.
>>THAT CLARIFIES.
THANKS, SUSAN.
I'M PASSING BACK TO GEORGE WHO
IS GOING TO MODERATE THE
DISCUSSION.
>>THANKS, NORA.
I THINK I'LL LEAD WITH A
QUESTION FOR JEFF BOISSONEAULT.
IT MIGHT HAVE ARPA-H
IMPLICATIONS.
JEFF, MY QUESTION FOR YOU IS, IS
EMOTIONAL PAIN, CAN YOU MEASURE
IT IN USUAL HUMAN SUBJECTS AND
SOME OF THESE STUDIES?
ASSUMING YOU COULD, IS IT A
COVARIATE?
EXPLAIN SOME OF THE VARIANTS.
>>YEAH.
EMOTIONAL PAIN IS INTERESTING IN
THIS CONTEXT BECAUSE, YOU KNOW,
WE'RE APPLYING WHAT FOLKS CALL
PHYSICALLY PAINFUL STIMULI, HEAT
PAIN, PRESSURE PAIN, PEOPLE ARE
COMING IN WITH JAW PAIN, FOR
INSTANCE WHICH WE TEND TO THINK
OF AS VERY PHYSICAL.
BUT ALL OF THOSE PHYSICAL
STIMULI HAVE AN EMOTIONAL
COMPONENT TO IT.
AND ONE OF THE ASPECTS OF THE
CANUE MODEL AND WHAT OTHER FOLKS
ARE WORKING ON, NEGATIVE AFFECT
IS PLAYING A REALLY IMPORTANT
ROLE, MEDIATING ASSOCIATION
BETWEEN PAIN AND SUBSTANCE USE.
AND THE WAY I THINK OF IT IS
THAT PAIN OR PHYSICAL PAIN IS
ONE SOURCE OF THAT EMOTIONAL
DISTRESS OR PAIN, WHATEVER YOU
CALL IT, BUT IT COULD BE
SOMETHING ELSE.
IT COULD BE, YOU KNOW,
SOCIOECONOMIC STRESSOR, SOME
OTHER TRAUMA, SOCIOLEGAL ISSUE.
COULD BE A BREAKUP, RIGHT,
THAT'S CAUSING THAT DISTRESS FOR
SOMEBODY.
IT MIGHT HAVE A SIMILAR
RELATIONSHIP FOR THEM WITH THEIR
DRINKING OR THEIR SUBSTANCE USE.
SO TO ANSWER YOUR QUESTION, YES,
I THINK THAT IS SOMETHING WE CAN
MEASURE WELL IN AN EXPERIMENTAL
CONTEXT OR EVEN IN AN ECOLOGICAL
MOMENTARY ASSESSMENT CONTEXT IN
TERMS OF LOOKING AT VARIOUS
NEGATIVE AFFECTIVE COMPONENTS
THAT ARE TYPICALLY RELATED TO
PAIN OR DISTRESS SO THAT COULD
BE ANXIETY, FRUSTRATION,
DEPRESSION, FEAR, ANGER, ALL OF
WHICH ARE ASSOCIATED WITH NOT
JUST, YOU KNOW, CHRONIC PAIN
CONDITIONS BUT ALSO WITH, YOU
KNOW, WHAT WE THINK MORE OF
EMOTIONAL PAIN.
>>THANKS.
AND BEFORE I GET TO YOUR
QUESTION LIVE HERE, FOR SUSAN,
FOR YOU, A QUESTION.
OH, THAT'S YOU.
ASK YOUR QUESTION LIVE.
>>GOOD TO HEAR YOUR VOICE AND
SEE YOUR FACE.
>>LIKEWISE.
>>I'M GOING TO STATE THE
QUESTION AND BUILD ON IT.
THE QUESTION IN THE CHAT WAS
AROUND HOW TO AVOID UNNECESSARY
DUPLICATION AND THE DIGITAL
HISTOPATHOLOGY EXAMPLE IS ONE
WHERE THERE'S A LOT OF STARTUPS
AND NOT SO START-UP COMPANIES
THAT ARE DOING THAT AND SEEM TO
HAVE GOOD COMMERCIAL TRACTION.
AND SO I'M CURIOUS HOW ARPA-H IS
GOING TO HAVE A SUFFICIENT
SENSING MECHANISM TO AVOID
DUPLICATION OF WHAT'S IN THE
MARKET AND RELATED TO THAT WHAT
IS, OTHER THAN YOU DOING A LOT
OF THESE GREAT TALKS, WHAT IS
THE PLAN FOR ENGAGING SOME OF
THE TOP TIER INVESTORS OUT THERE
SO THAT THEY CAN BE PARTNERS IN
CO-INVESTING OR SCALING UP
THINGS THAT YOU ALL END UP BEING
EARLY INVESTORS IN SO THAT
YOU'RE CONTRIBUTING TO THAT
FINANCING STAC AND ACCELERATING
AS OPPOSED TO CREATING
UNNECESSARY REDUNDANCY THERE.
>>GREAT QUESTION.
ON DUPLICATION, THE GOOD NEWS
THERE'S A LOT GOING ON IN THE
HEALTH ECOSYSTEM.
WE FULLY UNDERSTAND THAT WE
FULLY APPRECIATE THAT.
WE'RE ACTUALLY BUILDING OUT WHAT
WE HOPE TO BE, OBVIOUSLY THIS
WILL GROW AS WE GROW, A
LANDSCAPE ANALYSIS CAPABILITY BY
WHICH WE TAKE BOTH AN AUTOMATED
DATA TECHNICAL APPROACH TO
INGEST LARGE SETS OF INFORMATION
RELATED TO VARIOUS PROGRAM
ACTIVITIES, SO THINKING ABOUT
EVERYTHING THAT'S IN THE PUBLIC
DOMAIN COUPLED WITH EVERYTHING
THAT WE CAN ACCESS WITHIN THE
GOVERNMENT DOMAIN AND INTEGRATE
INTO A DISCOVERABLE DATASET SO
WE CAN BE THOUGHTFUL.
WE UNDERSTAND THAT THERE IS
NECESSARY DUPLICATION ON
OCCASION, RIGHT?
BECAUSE SOMETHING IS, YOU KNOW,
TAKEN TO A CERTAIN LEVEL AND
WARRANTS COMPLEMENTARY
ACTIVITIES OR THE WAY THAT SOME
PARTICULAR ENTITY IS WORKING ON
A PROBLEM IS NOT NECESSARILY
GOING TO GET IT TO WHERE WE NEED
TO BE TO TRANSLATE TO PRODUCT
DEVELOPMENT CYCLE SO WE'LL TAKE
THAT APPROACH.
PLUS WE'RE BRINGING IN TECHNICAL
EXPERTS FROM, AGAIN, NIH AND
OTHER PLACES TO MAKE SURE WE
HAVE A BROAD SET OF INPUTS PRIOR
TO LAUNCHING A PROGRAM AND
PERFORMER DAYS, WE BRING IN
ANYONE INTERESTING IN RECEIVING
ARPA-H FUNDS FOR A PARTICULAR
ACTIVITY, AND WE OPEN THOSE UP
AS BROAD AS THERE'S NO
LIMITATIONS ON WHO CAN
PARTICIPATE, SO WE HOPE WE ALSO
CAN HEAR FROM THOSE THAT MAY BE
WORKING ON A PARTICULAR
TECHNOLOGY OR DOMAIN TO BE ABLE
TO UNDERSTAND WHAT THE STATE OF
THE TECHNOLOGY IS.
SO WE THINK BETWEEN THOSE THREE
SORT OF LAYERS WE'LL HAVE A
PRETTY SOLID UNDERSTANDING OF
WHO MIGHT ALREADY BE WORKING IN
THE SPACE.
IN TERMS OF THE COMMUNITY, AS
PART OF THE HUB AND SPOKE MODEL
WE'RE LAUNCHING AN INVESTOR HUB
SORT OF HUB, WE HAVE THREE, ONE
IS FOCUSED ON OUR CUSTOMERS,
PATIENTS, AS CLOSE TO THE
CUSTOMER AND PATIENT EXPERIENCE
AS POSSIBLE THROUGH GEOGRAPHY
AND ENTITIES.
AND INVESTOR HUB TO BRING IN
VENTURE CAPITALISTS, INDIVIDUALS
PULLING TECHNOLOGY THROUGH THE
DEVELOPMENT PIPELINE AND
ALLOWING FOR SUCCESSFUL
TRANSITION TO THE COMMERCIAL
MARKET.
SO YOU'RE GOING TO HEAR MORE
ABOUT OUR PLANS IN THAT SPACE.
WE FULLY UNDERSTAND THAT WE'RE
NOT A LONG-TERM FUNDER.
PRODUCTS THAT WE WILL DEVELOP WE
DON'T WANT THEM TO GO TO A
VALLEY OF DEATH WHICH HAPPENS IN
GOVERNMENT PIPELINES, SO WE'LL
START EARLY AND MEET OFTEN WITH
POTENTIAL TRANSITION PARTNERS OR
FOLKS THAT CAN HELP US WITH THE
VENTURE APPROACH.
>>GREAT.
THANK YOU.
ONE IDEA TO BUILD ON THAT
LANDSCAPE, BARDA HAS DONE A GOOD
JOB BUILDING OUT THAT ECOSYSTEM
OF INCUBATORS AND I BELIEVE THEY
STARTED THAT LANDSCAPE
ASSESSMENT, AND ALSO I'M HAPPY
TO CONNECT YOU WITH FOLKS AT
ORGANIZATIONS LIKE ROCK HEALTH
AND OTHER INCUBATORS THAT HAVE
QUITE ROBUST DATABASES OF
DIGITAL HEALTH EXCLUSIONS OUT
THERE.
I'VE DONE RESEARCH WITH ROCK
HEALTH AND START-UP DATABASE,
I'M SURE THEY WOULD OFFER THOSE,
HAPPY TO INTRODUCE YOU TO THOSE
FOLKS.
THANK YOU.
>>FANTASTIC.
THANK YOU.
>>NORA HAS A QUESTION.
IF YOU ALL COULD USE THE
REACTION AND MOVE YOUR PANEL
RIGHT UP FRONT AND I CAN SEE YOU
TO CALL ON YOU.
ANYONE ELSE WITH QUESTIONS,
PLEASE JOIN THE QUEUE.
NORA, YOU'RE NEXT.
>>I REALIZE HOW COMPLEX OF AN
ISSUE WHAT YOU'RE AIMING TO DO.
I WAS ASKING THE QUESTION ABOUT
THE ISSUE OF HOW DOES ONE REVIEW
AND EVALUATE MORE LIKELY TO HAVE
A LARGE IMPACT BECAUSE YOU DON'T
WANT TO DO PROGRESSIVE, YOU WANT
TO DO SOMETHING THAT BE
TRANSFORMATIVE.
THIS PERTAINS TO THE QUESTION OF
ANDREW, MANY THINGS THAT ARE THE
LOWER HANGING FRUITS ARE ALREADY
GOING TO BE TACKLED BY MANY
COMPANIES.
HOW TO IDENTIFY AREAS WHERE
THOSE COMPANIES ARE NOT KEEPING
THEIR EYES, OTHERWISE THEY ARE
GOING TO BE DEVELOPED.
WHAT ARE AREAS THAT HAVE
POTENTIAL TO ACTUALLY ADVANCE
THIS IN WAYS.
THE COMPLETE QUESTION, IN THE
PROCESS OF SELECTION, HOW DO YOU
ENTER THESE INTO YOUR VALUE OF
THE PROGRAM, NUMBER ONE.
NUMBER TWO, IN THIS ONE, IN
TERMS OF I GUESS THERE WOULD BE
FLEXIBILITY IN TERMS OF AMOUNT
OF FUNDS THAT YOU COULD PUT FOR
A GIVEN PROJECT BUT WHAT ABOUT
THE TIMELINE?
I MEAN, BECAUSE THE BOLDER THE
ATTEMPT TO DO SOMETHING, THE
TIME THAT'S NEEDED.
THE THIRD ONE RESONATING IN
TERMS OF TAKING ADVANTAGE OF
DATABASES THAT EXIST, I HAVE
BROUGHT THIS UP BEFORE, HOW DO
WE APPLY PREDICTION MODELING
EARLY ON AS YOU'RE BUILDING YOUR
PORTFOLIO SO THAT YOU CAN LEARN
ABOUT WHAT ARE SUCCESSES AND
WHAT ARE FAILURES, WHAT PREDICTS
ISSUES WHERE WE CAN MAKE
ADVANCE.
THESE ARE COMPLEX AND NOT
SIMPLE.
IF THEY WERE SIMPLE ARPA-H
WOULDN'T EXIST BUT WHAT ARE YOUR
THOUGHTS?
>>WELL, I'LL START THE FIRST
QUESTION HOW DO WE PRIORITIZE.
I LAID OUT THE FOUR LARGE BINS,
THE FOUR FOCUS AREAS.
RIGHT NOW THAT'S THE EXTENT OF
OUR PRIORITIZATION.
WE'RE REALLY LOOKING AT THINGS,
IT'S A BOTTOM-UP APPROACH.
SO WHEN WE GET APPLICATIONS TO
OPEN VAA OR HAVE A PROGRAM
MANAGER MAKE A PITCH, WE SAY
WHAT WOULD BE THE IMPACT OF
THIS?
WHAT IS THE TRANSFORMATION INTO
THE HEALTH ECOSYSTEM THAT
THROUGH THIS APPROACH YOU'RE
ACTUALLY ACHIEVING?
AND WHEN A PROGRAM MANAGER COMES
IN THEY HAVE ALREADY GOT A
STRONG SENSE FOR THE CHALLENGE
AND HEALTH ECOSYSTEM, HOW THEY
THINK IT'S GOING TO HAVE AN
IMPACT.
WE HAVE A LOT OF TECHNICAL
TALENT ON OUR TEAM, PLUS
REACHBACK FROM A NUMBER OF
DIFFERENT PARTNERSHIPS, PRIVATE
SECTOR-TYPE PARTNERSHIPS.
EVEN IF THEY ARE THINKING THIS
IS GOING TO HAVE AN IMPACT, I'M
MAKING THIS UP, IT'S GOING TO BE
IMPACTED AND BENEFIT 200,000 OR
400,000 INDIVIDUALS, WHAT NOT.
IF WE THEN ASK WHAT IF YOU DO
SOMETHING SLIGHTLY DIFFERENT,
THOUGHT ABOUT IT IN THIS WAY,
TOOK THAT PARTICULAR APPROACH,
YOU COULD SCALE SOMETHING THAT
WOULD HAVE AN IMPACT LESS THAN A
MILLION PEOPLE AND POTENTIALLY
IMPACT 30 TO 40 TO 50 MILLION
PEOPLE.
IF THIS ITERATIVE APPROACH,
WHERE IT'S A GREAT IDEA AND WE
MAKE IT EVEN BETTER, AND THEN
YOU TALK ABOUT THE TIME
HORIZONS.
IT'S COMPRESSED, RIGHT?
I DIDN'T GET INTO THIS BUT WE --
OUR PROGRAM MANAGERS ARE ON A
LIMITED TIME FRAME.
THEY COME FOR THREE YEARS, THEY
CAN POTENTIALLY EXTEND FOR
ANOTHER THREE YEARS.
THEY ARE NOT LONG-TERM
GOVERNMENT EMPLOYEES.
IT'S A SPRINT FROM DAY ONE.
AND OUR PROGRAMS REALLY ONLY
LAST TWO TO FOUR YEARS.
SO EVERY PROGRAM MANAGER HAS TO
DESIGN THEIR PROGRAMS WITH 12,
18, 24-MONTH MILESTONES,
GO/NO-GO AT 24 MONTHS,
POTENTIALLY ANOTHER TWO YEARS
AFTER THAT.
THESE, WE'RE TAKING ON REALLY
BOLD CHALLENGING PROBLEMS TO AN
AGGRESSIVE TIME LINE.
WE HAVE ALL OF THOSE PARTNERS
THAT I TALKED ABOUT BETWEEN
TECHNICAL EXPERTISE AND VENTURE
AND COMMERCIAL PARTNERS AND WE
PACKAGE IT ALL TOGETHER AROUND A
PROGRAM, AND WE PUT REALLY HIGH
HARD DEMANDS ON PROGRAM MANAGERS
AND THEN THEY CASCADE TO THE
PERFORMERS.
THIS HAS BEEN A SUCCESSFUL MODEL
DARPA USED.
WE UNDERSTAND THE HEALTH
ECOSYSTEM AND DEFENSE ECOSYSTEM
ARE VERY DIFFERENT BUT WE'RE
GOING TO EMPLOY THAT MODEL.
WE FEEL IN THE FIRST SIX MONTHS
OF OPERATIONS, FIRST COUPLE
MONTHS NOW THAT WE'VE HAD
PROGRAMS BEING DESIGNED WE'RE
FEELING PRETTY GOOD ABOUT HOW
THAT'S POSITIONING US FOR
SUCCESS.
AND WHAT WE'RE SEEING, WHO WE'RE
HIRING, PROGRAMS WE'RE ABOUT TO
LAUNCH.
SO WE'RE PRETTY CONFIDENT THIS
IS GOING TO WORK.
>>CHUCK, DO YOU WANT TO ASK
YOUR QUESTION?
IS SOMEONE SHARING THEIR SCREEN?
WE LOST THE VISUAL.
>>SURE.
I DON'T KNOW WHETHER YOU CAN
HEAR ME, GEORGE.
>>GO AHEAD.
>>JUST SOME DoD, DR. VOLKOW
CITED HER STUDY, NEED FOR DRUG
SCREENING IN ADOLESCENTS, WE HAD
A LARGE ANONYMOUS SURVEY IN
DoD, IN THE ARMY SPECIFICALLY,
THAT LOOKED AT FOLKS THAT HAD
USED OPIATES AND WHAT WE FOUND,
AGAIN THESE ARE FOLKS SINCE IT'S
IN ILLEGAL AND WE SCREEN IN OUR
SYSTEM WITH DRUG DETERRENCE
TESTING, MY HYPOTHESIS IS OPIATE
USE IN OUR RANKS IS PRIMARILY
NOT OPIATE DEPENDENCE, REAL
REGULAR USERS BUT MORE
RECREATIONAL USERS, MORE LIKE
TEENAGE USERS.
WHAT WE FOUND IS OF THOSE WHO
ENDORSED OPIATE USE, OPIOID USE,
45% SCREENED POSITIVE ON AN
AUDIT FOR ALCOHOL USE PROBLEMS.
OVER.
AND I GUESS ONE OF THE QUESTIONS
THAT RAISES FOR ME IN A CLINICAL
SETTING, EVEN WITH TEENAGERS
BEHIND CLOSED DOORS, IT MAY BE
MUCH MORE ACCEPTABLE TO ASK
ABOUT ALCOHOL USE AND YOU
ACTUALLY MAY HAVE SOME USEFUL
DATA IN YOUR HANDS IF HE LOOK AT
TWELFTH GRADERS THAT TRIED
ALCOHOL TO LOOK AT HOW MANY OF
THEM ALSO ARE THE ONES WHO WERE
SMOKING MARIJUANA.
OVER.
>>CORRECT ME IF YOU GET THIS
WRONG, CHUCK, BECAUSE YOU FADED.
WHEN YOU SCREENED THE TROOPS FOR
OPIOIDS, 45% WERE ACTUALLY ALSO
COMING UP POSITIVE FOR ALCOHOL?
IS THAT CORRECT?
OF THE OPIOID USERS?
>>YEAH, AND NOT JUST ALCOHOL
USE BUT ALCOHOL AT A PROBLEMATIC
DRINKING LEVEL ON THE AUDIT C.
>>AUDIT LEVEL, OKAY.
GOT IT.
I DON'T KNOW WHETHER YOU WANT TO
RESPOND, SUSAN.
AND WHILE I HAVE THE FLOOR,
ANOTHER QUESTION CAME IN THROUGH
THE CHAT FROM MY DEPUTY THAT I
WAS ALLUDING TO EARLIER AND THEN
MAYBE, SUSAN, YOU COULD COMMENT
AND THEN JEFF BOISSONEAULT.
WHAT ABOUT PAIN MANAGEMENT?
YOU HAD SLEEP UP THERE BUT PAIN
IS SO PREVALENT IN OUR SOCIETY,
20% OF PEOPLE WITH CHRONIC PAIN
ACCORDING TO WHAT JEFF SHOWED.
SO IS THAT A TOPIC THAT COULD BE
UTILIZED IN AN ARPA-H PROGRAM?
>>ABSOLUTELY.
WE TALK ABOUT THAT INCESSANTLY,
WAITING FOR A PROGRAM MANAGER
WHO WANTS TO CHAMPION THAT.
ARE THERE ALTERNATIVES TO
CURRENT PHARMACEUTICAL PAIN
MANAGEMENT CAPABILITIES, WHAT
WOULD BE A SCALABLE ALTERNATIVE
THAT'S AS EFFECTIVE FOR THE
BROADEST SET OF POPULATION, SO
WHETHER THAT'S PEDIATRIC TO
GERIATRIC OR SOME SIGNIFICANT
SUBSET, SO WE'RE SUPER OPEN AND
WE FULLY RECOGNIZE WHAT A HUGE
CHALLENGE THIS IS IN THE HEALTH
ECOSYSTEM.
IF ANYBODY HAS IDEAS OR WANTS TO
BE A PROGRAM MANAGER, PLEASE
FOLLOW UP.
>>JEFF, DO YOU WANT TO QUICKLY
COMMENT?
I DON'T THINK YOU WANT TO BECOME
A PROGRAM MANAGER BUT WHO KNOWS.
>>I'LL SAY WHAT I THINK THE
CHALLENGES ARE IN PAIN
MANAGEMENT, DEVELOPING NEW
MANAGEMENT STRATEGIES,
ESPECIALLY PHARMACEUTICALS.
I THINK THERE'S A LACK OF
CROSS-TALK BETWEEN OUR CLINICAL
INVESTIGATORS AND OUR
PRE-CLINICAL AND MORE BASIC
SCIENTISTS, THAT'S ONE OF THE
REASONS I'M EXCITED TO HAVE
MOVED TO WHERE I JUST MOVED TO
START WORKING IN THAT AREA A
LITTLE BIT MORE ABOUT
BACK-TRANSLATING WHAT WE'RE
SEEING IN HUMANS TO RODENTS,
BEING MORE INTENTIONAL ABOUT
THAT.
THE PAIN MANAGEMENT DRUG
DEVELOPMENT PIPELINE IS TRULY
THE VALLEY OF DEATH,
UNFORTUNATELY.
>>I'M GOING TO INTERRUPT THE
QUEUE.
I BELIEVE I MISUNDERSTOOD
CHUCK'S QUESTION.
NORA IS GOING TO ANSWER AND
WE'LL MOVE THROUGH THE QUEUE OF
OTHER QUESTIONS.
>>I THINK THAT FOR THE QUESTION
OF PAIN TOO, THERE'S A MAJOR
INITIATIVE RIGHT NOW AT NIH
PUTTING ENORMOUS AMOUNT OF
RESOURCES TO BRIDGE THAT VALLEY
OF DEATH.
WE'RE COMING BACK TO THE
QUESTION IN TERMS OF HOW DO WE
SCREEN FOR TEENAGERS, EVEN IF
THE DOOR IS CLOSED.
I THINK YOU'RE ABSOLUTELY RIGHT.
IN FACT THERE IS DATA AS YOU
PROBABLY KNOW ASKING FOR WHETHER
YOU HAVE TRIED LEGAL DRUGS
FIRST, IT'S A VERY HIGH
PREDICTOR THAT YOU CAN THEN
FOCUS QUESTIONS TO DETERMINE
THOSE MORE LIKELY TO HAVE TAKEN
ILLICIT DRUGS.
THIS HAS LED TO SURVEYS THAT CAN
BE ADMINISTERED RAPIDLY SUCH
THAT IF YOU SAY NO THE
LIKELIHOOD YOU TAKE AN ILLICIT
DRUG IS NOT THERE.
SO, YEAH, THESE TYPE OF SURVEYS
ARE SORELY NEEDED IN CLINICAL
PRACTICE BECAUSE PHYSICIANS ARE
NOT GOING TO DO LENGTHY
ASSESSMENTS TO DETERMINE IF
SOMEONE IS TAKING DRUGS.
SO THE CTN THAT NIDA HAS
PROBABLY HAS DEVELOPED ACTUALLY
A STRATEGY FOR SCREENING
TEENAGERS AND A DOCTOR THE THE
AT NIDA IS LEADING THAT EFFORT.
WE CAN GIVE YOU MORE SPECIFICS.
>>PATRICIA POWELL, TRISH POWELL
FROM NIAAA, DEPUTY DIRECTOR, HAS
A QUESTION.
>>I WANTED TO FOLLOW UP ON YOUR
QUESTION ON TINY BIT.
I WAS STRUCK IN JEFF'S TALK,
DIFFERENCE BETWEEN PERCEIVED
PAIN RELIEF AND PAIN INTENSITY
SENSITIVITY.
I JUST WONDER IF THAT PRESENTS
AN OPTION, FOR EXAMPLE, IN
ARPA-H TYPE OF ENDEAVOR THAT
WOULD FOCUS NOT SO MUCH
NECESSARILY ON RELIEVING THE
PAIN INTENSITY BUT ON THE
PERCEPTION OF PAIN.
>>ABSOLUTELY.
I THINK WE WOULD HAVE -- BIG
QUESTIONS WOULD BE WHAT WOULD IT
TAKE FROM THE ORIGINAL
CONCEPTUALIZATION OF THIS AS AN
AREA, PERCEPTION OF PAIN, TO
TRANSLATING INTO PATIENTS, AND
THEN ARE THERE ANY LIMITATIONS
IN WHAT PATIENTS WOULD
POTENTIALLY DERIVE BENEFIT FROM
THIS TYPE OF NEW THINKING OR NEW
CAPABILITY, WHATEVER THE NEW
PROCESS, WHATEVER IT WOULD BE
BECAUSE WE REALLY WANT TO MAKE
SURE THAT IT WAS SOMETHING THAT
I DIDN'T TALK ABOUT THIS BUT WE
HAVE THAT SORT OF PIPELINE OF
OUR PROGRAMS, WITH AN
EXPECTATION THAT WITHIN FOUR
YEARS THEY ARE GOING TO MOVE
THROUGH THAT PIPELINE TO GET AS
CLOSE AS POSSIBLE TO BENEFITING
PATIENTS SO THAT WOULD JUST BE
PART OF THE ITERATIVE PROCESS
THAT WE WOULD TAKE WHEN THINKING
ABOUT THIS CONCEPTUALLY.
ABSOLUTELY, IT COULD BE A GAME
CHANGER IF IT WAS SUCCESSFUL AND
SCALED IT COULD BE AN ABSOLUTE
GAME CHANGER.
>>I'M GOING TO JUMP IN RAPIDLY.
I WAS TELLING GEORGE.
THERE WAS A PAPER A YEAR AGO IN
A PRE-CLINICAL MODEL IN RODENTS
THAT SHOWED IN ANIMAL MODELS YOU
CAN ACTUALLY INHIBIT, BY
INHIBITING SIGNALING TO AMYGDALA
DO NOT MODIFY PERCEPTION OF PAIN
BUT THE ANIMALS WERE ABLE TO
KEEP ON DOING FUNCTIONING
PERFECTLY NORMALLY.
SO IF YOU TAKE THAT FINDING AND
BRING IT UP WITH NEW
TECHNOLOGIES LIKE, FOR EXAMPLE,
LOW INTENSITY FOCUS ULTRASOUND
ALLOWS TO PENETRATE DEEP INTO
THE BRAIN COULD INHIBIT
AMYGDALA, COULD BE A PROCESS
POTENTIALLY TO DO IN HUMANS,
THERAPEUTIC INTERVENTION.
I BRING IT UP BECAUSE IT IS
PERTINENT.
>>YOU CAN ALWAYS BRING UP MY
FAVORITE BRAIN REGION, THE
AMYGDALA.
SHELLY GREENFIELD HAS A
QUESTION.
>>YEAH, MAYBE A SERIES OF
COMMENTS AND PERHAPS A QUESTION.
IT'S SOME COMMENTS FROM THE
MORNING AND MAYBE A QUESTION.
BUT YOU PRESENTED BOTH GEORGE
AND NORA, PRESENTED A LOT OF
RICH DATA, A LOT OF
EPIDEMIOLOGIC DATA, QUESTIONS
FOR US AROUND RESEARCH
QUESTIONS, HOW WE CAN DO MORE
INTERVENTIONS, ESPECIALLY I'M
THINKING ABOUT CLINICAL
INTERVENTION, SCREENING, BRIEF
INTERVENTION, THERE'S SOME
SCREENING, NOT MUCH
INTERVENTION, AND WE WERE
TALKING ABOUT TAILORED
TREATMENTS FOR DIFFERENT
POPULATIONS.
ONE OF THE TENSIONS IN TERMS OF
ADDRESSING SOME OF THE SUBSTANCE
USE-RELATED ISSUES THAT WE HAVE
IN THE U.S. IS BOTH HOW DO WE DO
UNIVERSAL SCREENING AND
INTERVENTIONS WHICH ACTUALLY
REPRESENT QUESTIONS AROUND TOUCH
POINTS WITHIN THE ENTIRE MEDICAL
SYSTEM, WHICH WE'RE PRETTY BAD
AT AT THE MOMENT, AND THEN WHEN
WE'R ADMINISTRATION TREATMENT
HOUSE DO WE TAILOR TO
POPULATIONS TO BRING PEOPLE INTO
CARE AND RETAIN THEM.
THERE'S RESEARCH HOW TO
INSTITUTE SCREENING AND
INTERVENTIONS AT MANY DIFFERENT
TOUCH POINTS IN THE HEALTH CARE
SYSTEM, AND RESEARCH THAT LOOKS
AT TAILORED TREATMENTS, AND WE
NEED BOTH OF THOSE THINGS BUT
THEY ARE RELATED AND SEPARATE
QUESTIONS.
I JUST WANTED TO BRING THAT
TOGETHER.
A LOT OF DATA THAT YOU'RE
SHOWING ARGUES FOR MORE RESEARCH
IN BOTH OF THOSE AREAS.
WE'RE NOT VERY GOOD AT SCREENING
AND NOT VERY GOOD AT ALL THE
TOUCH POINTS IN THE CLINICAL
CARE SYSTEM IN TERMS OF
UNDERSTANDING WHEN PEOPLE ARE
JUST BEGINNING TO HAVE PROBLEMS
WITH SUBSTANCES, ALCOHOL, BUT
YOU'RE LOOKING AT ADOLESCENTS,
WOMEN, OTHER VULNERABLE
POPULATION, CANNABIS, ALCOHOL,
VAPING, TOBACCO, YOU KNOW,
NCI-RELATED DATA THAT'S BEEN
SHOWN, THERE'S A LOT OF RESEARCH
TO BE DONE, HOW DO YOU
INCENTIVIZE TOUCH POINTS BECAUSE
WE'RE BAD AT THIS IN THE
CLINICAL CARE SYSTEM, REALLY
BAD.
WE THINK WE'RE BETTER THAN WE
ARE BUT WE'RE NOT VERY GOOD AT
IT.
THAT'S ONE THING.
I WAS GOING BACK TO DATA AROUND
ESCALATING ALCOHOL USE IN WOMEN,
THE CLEAR RELATIONSHIP BETWEEN
ALCOHOL USE AND BREAST CANCER,
WOMEN STILL DON'T KNOW THAT,
DATA THAT SHOWS PEOPLE DON'T
KNOW THAT ALCOHOL PRESENTS
CANCER RISKS.
I WAS THINKING ABOUT TODAY'S
U.S. PUBLIC HEALTH SERVICE TASK
FORCE RECOMMENDATIONS AROUND
MOVING MAMMOGRAPHY TO AGE 40
RATHER THAN 50, IT'S AN
OPPORTUNITY I WOULD THINK FORE
NIAAA TO SAY, HEY, WOMEN, YOU
JUST SAW THIS DECREASE TO 40
WHEN MAMMOGRAPHY SHOULD START,
AND THERE ARE OTHER MODIFIABLE
VARIABLES, DID YOU KNOW ABOUT
ALCOHOL?
I WOULD URGE GETTING OUT THERE
RIGHT NOW.
IN OUR RESEARCH AND STUDIES WITH
CLINICAL POPULATIONS, WOMEN
COMING FOR TREATMENT FOR
SUBSTANCE USE DISORDERS WE
PRESENT A LOT OF HEALTH RELATED
DATA, ALMOST ALL WOMEN NEVER
HEARD OF IT BEFORE.
ASTOUNDING.
WE SEE THAT WOMEN INCLUDING
YOUNG WOMEN, WOMEN CONSIDER IT
QUITE INTERESTING AND
MOTIVATIONAL AROUND THEIR
OVERARCHING HEALTH WHICH GETS ME
BACK TO THE TOUCH POINTS BECAUSE
THERE'S SO MANY TOUCH POINTS WE
HAVE WHERE THERE ARE MULTIPLE
MISSED OPPORTUNITIES DISCUSSING
THINGS WITH PATIENTS WHO COME IN
TO EVERY SINGLE -- PEDIATRICS,
OB, YOU KNOW, GYN, EVERY PLACE
PEOPLE SHOW UP, MEN AND WOMEN,
BUT I'M THINKING ABOUT WOMEN
RIGHT NOW, WE DO NOT IN MENTAL
HEALTH CARE, JUST THE WHOLE
THING, WE DON'T REALLY TALK TO
PATIENTS ABOUT ANY OF THIS
STUFF.
AND AROUND SCREENING WITH
ADOLESCENT POPULATIONS THERE'S
DATA THAT SHOWS KIDS, YOUNG
PEOPLE, TRANSITIONAL AGE YOUTH,
THEY ARE A LITTLE MORE HONEST
WHEN THEY ARE DOING DIGITAL
SCREENING.
RATHER THAN BEHIND THE CLOSED
DOORS, IF YOU CAN ADMINISTER
THESE THINGS YOU KNOW HOW YOU
HAVE TO GET SURVEYS BEFORE YOU
GO TO CARE, IF YOU CAN
ADMINISTER WHERE IT'S AN
INTERACTIVE INTERFACE ASKING,
YOU'RE MORE LIKELY TO GET DATA
ABOUT WHAT'S ACTUALLY HAPPENING
FORE ALL THE COMPLICATED REASONS
USING DIGITAL PLATFORMS.
THE QUESTION AFTER THAT WHAT
DOES THE CLINICIAN DO WITH THE
INFORMATION?
SO, ONE OF THE THINGS WE'VE BEEN
TRYING TO WORK ON IS TAKING LIVE
THINGS AND STARTING TO PUT THEM
ON LIKE WEB INTERFACES THAT JUST
DON'T TAKE VERY MUCH TIME, WHERE
DOCTORS OR CLINICIANS CAN
BASICALLY HAVE SOMETHING THAT
THEY CAN DO.
IT'S VERY HARD TO ASK A BUSY
CLINICIAN TO SCREEN AND FEEL AT
A LOSS FOR THE NEXT STEP.
THERE'S A TON OF STUFF WE CAN
DEVELOP IN THAT REGARD WHERE YOU
CAN SCREEN PEOPLE AND THEN THERE
IS SOMETHING AS A FIRST
INTERFACE, NOT THE PERFECT THING
BUT IT IS SOMETHING.
SO THOSE ARE JUST SOME THINGS
THAT I WAS THINKING ABOUT DURING
THIS MORNING'S PRESENTATIONS.
THE ONLY OTHER THING ABOUT THE
CORE RESOURCES, NIAAA PUT A LOT
OF ENERGY AND EFFORT INTO I
WONDER WHETHER THOSE ARE NOW
LINKED TO ALL THE MEDICAL
SOCIETIES, BECAUSE THAT'S WHERE
YOU NEED TO DISSEMINATE THE CORE
RESOURCES.
I MEAN, THEY SHOULD BE LINKED
SOMEHOW TO EVERY MEDICAL
SOCIETY.
YOU KNOW, MEDICAL, PHYSICIANS DO
NOT DO A GOOD JOB WITH ALCOHOL
RELATED, THEY JUST DON'T.
SO THERE ARE GREAT CORE
RESOURCES THAT YOU'VE DEVELOPED,
EXCELLENT, BUT IF NOBODY GETS ON
THERE AND USES THEM, YOU KNOW,
IT'S NOT GETTING WHERE YOU WANT
TO GO SO I WAS THINKING ABOUT
HOW TO DISSEMINATE THAT
INFORMATION.
THE OTHER THING, HOW TO URGE
PEOPLE TO INCENTIVIZE THE USE OF
THOSE RESOURCES.
THAT'S ANOTHER THING.
HOW DO YOU INCENTIVIZE.
I'LL STOP THERE.
>>THANK YOU FOR THAT.
WE TOTALLY AGREE.
STAFF IN OUR DIVISION OF
TREATMENT AND RECOVERY WHO LEDED
DEVELOPMENT OF HBCR ARE WORKING
HARD TO DISSEMINATE THROUGH
VARIOUS MEDICAL SOCIETIES,
DIFFERENT ORGANIZATIONS,
PROFESSIONAL ORGANIZATIONS.
SO IT'S SOMETHING WE'RE
REALLY -- WE RECOGNIZE THE NEED
AND PROBLEM AND WE'RE WORKING
HARD TO TRY TO DISSEMINATE.
IT IS A TREMENDOUS CHALLENGE.
>>SO, SUSAN, I WANT TO -- YOU
CAN REMEMBER WHAT SHELLY JUST
SAID BECAUSE IF I MEET WITH YOU
AT SOME POINT I'LL RAISE SOME
SAME ISSUES.
ONE OF THE BIG CHALLENGES.
THERE ARE TWO OTHER QUESTIONS SO
I'LL MOVE WITH THE QUESTIONS.
SHELLY, THANK YOU VERY MUCH.
I MEAN, YOU TOUCH A NERVE IN OUR
INSTITUTE.
BUT WE'RE A SMALL INSTITUTE SO
WE CAN ONLY DO SO MUCH.
WE'LL BE IN TOUCH ON SOME OF
THESE ISSUES.
WOULD ARPA-H SUPPORT -- FROM
DOMINIQUE LORANG, IF YOU CAN
TURN ON YOUR SPEAKER QUICKLY AND
ASK THE QUESTION YOURSELF, THAT
WOULD BE FINE.
IT'S AN ARPA-H QUESTION.
>>GIVEN HOW IMPORTANT PAIN IS,
HOW CHRONIC PAIN IS IN THE BROAD
POPULATION, GIVEN THE COMPLEX
RELATIONSHIP BETWEEN CHRONIC
PAIN OR EMOTIONAL PAIN WHICH
SUBSTANCE USE DISORDERS
INCLUDING ALCOHOL USE DISORDERS,
WOULDN'T ARPA-H SUPPORT THE
DEVELOPMENT OF NON-INVASIVE
SENSING TECHNOLOGIES THAT COULD
BE USED TO ASSESS PAIN LEVELS,
PHYSICAL OR EMOTIONAL PAIN
LEVELS IN THE BROAD POPULATION,
WOULD THAT BE SOMETHING OF
INTEREST IN.
>>ABSOLUTELY.
WE WERE JUST TALKING THE OTHER
DAY ABOUT -- HOW WOULD WE THINK
ABOUT A TECHNOLOGY THAT WOULD
ACTUALLY GO THROUGH A REGULATORY
APPROVAL PROCESS TO ALLOW IT TO
THEN BE USED IN A SORT OF
CLINICAL OUTPATIENT SETTING
GIVEN, YOU KNOW, ALLOWING
INDIVIDUALS TO HAVE A MORE SORT
OF QUANTITATIVE UNDERSTANDING OF
OUR OWN PAIN BUT SOMETHING THAT
COULD BE USED FOR CLINICIANS TO
HELP UNDERSTAND, YOU KNOW, AN
INDIVIDUAL'S PERCEPTION.
WE WERE THINKING ABOUT WE HAVE
NO PROGRESS, SO THIS IS ALL
SPECULATIVE, BUT IS THERE SOME
SORT OF WEARABLE DEVICE OR
BIOMONITOR YOU CORRELATE TO
SPECIFIC BIOMARKERS THAT WOULD
BE INDICATIVE OF WHEN SOMEBODY'S
EXPERIENCING OR FEELING A
CERTAIN STRESS EMOTION OR A PAIN
OR SOMETHING LIKE THAT, SO THAT
YOU ACTUALLY CAN MOVE IT FROM
THE VERY MUCH PERCEPTION-BASED,
YOU KNOW, INDIVIDUALIZED SORT OF
APPROACH TO SOMETHING THAT
ACTUALLY COULD BE A DEPLOYABLE
TECHNOLOGY VALIDATED IN A WAY
THAT THERE'S A REPRODUCIBILITY
THAT COULD BE TRUSTED BY
CLINICIANS, BY A PATIENT, AND SO
WHAT DID THAT ALL LOOK LIKE
TOGETHER AND SO THE ANSWER IS
YES, WE WOULD ABSOLUTELY TAKE
SOMETHING ON LIKE THIS, KNOWING
HOW CHALLENGING IT IS AND HOW
PREVALENT IT IS IN THE PATIENT
POPULATION.
SO, IT'S JUST A FUNCTION OF HOW
WOULD WE DESIGN THAT PROGRAM TO
ACTUALLY BUILD SOMETHING THAT
WOULD IMPROVE PATIENT OR
INDIVIDUAL EXPERIENCE THAT WOULD
BE VALIDATABLE, GET THROUGH
REGULATORY PROCESS, AND BE
RECOGNIZED IN SORT OF A CLINICAL
WORKFLOW.
>>YEAH, I COULD SEE COMPANIES
DEVELOPING SPECIALIZED SENSORS
THAT MIGHT PICK UP SPECIFIC
BIOMARKERS, COMBINATION USING
DIGITAL HEALTH TECHNOLOGIES TO
IDENTIFY POTENTIAL BIOMARKERS.
OKAY, GREAT.
THANK YOU.
>>ABSOLUTELY.
>>SO, WE HAVE A QUESTION FROM
MELISSA WALLS.
MELISSA?
>>YES, THANKS.
HI, EVERYONE.
HANG IN THERE, WE'RE GETTING TO
THE END OF A LONG DAY ON ZOOM IN
THE ROOM.
I'M GOING TO FOLLOW UP WITH A
LITTLE BIT OF WHAT SHELLY WAS
HEADED TOWARDS.
WE TALK OUTSIDE OF NIDA AS WELL.
SO MY QUESTION, I'LL GIVE THE
QUESTION AND CONTEXT.
WHAT SYNERGIES MIGHT WE CREATE
TO ADDRESS INTHE QUESTIONS THAT
YOU ALL HAVE BEEN HIGHLIGHTING
OVER THE MORNING?
AND NORA, EVERY SINGLE NIDA
COUNCIL MEETING I BRING THIS UP
BECAUSE DATA FOR BLACK WOMEN,
DATA FOR AMERICAN INDIAN AND
ALASKA NATIVE WOMEN IS JUST
GETTING WORSE EVERY TIME.
AND HOW DO WE DO TO BALANCE
PRAGMATISM WITH REVOLUTION?
I SIT IN MINNESOTA THINKING
ABOUT THE BEST BANG FOR THE
BUCK, IN THIS ONE MEETING A YEAR
WE HAVE.
AND WHERE WE SEE THE MOST
EXTREME PAIN AND LOSS OF COURSE
IS THE COMMUNITIES I JUST
MENTIONED, WOMEN, AS SHELLY WAS
TALKING ABOUT, AND THE
CONSEQUENCES OF ALL OF THESE
ISSUES, WE ALL CARE SO MUCH
ABOUT.
WE KNOW THEY ARE NOT RANDOMLY
DISTRIBUTED.
AND WHAT I'M HEARING US THINK
ABOUT THOUGH ARE SOLUTIONS THAT
FIT INTO THE CURRENT SYSTEMS OF
CARE OR CURRENTS RESEARCH OR
SCIENTIFIC PARADIGMS THAT ARE
NOT MAKING A MARK AT ALL,
NOTHING IS CHANGING, IT'S
GETTING ACTUALLY WORSE.
ONE THING TO INCLUDE, FOR
EXAMPLE, MORE AMERICAN INDIANS
AND A LARGE SCALE STUDY, BUT HOW
DO WE APPROACH ENGAGEMENT, USE
MEASURES WE KNOW MAYBE WERE
NEVER DEVELOPED WITH NON-WHITE
NON-MALE NON-MIDDLE CLASS FOLKS,
WE HAVE SO MUCH TO IMPROVE.
IT'S SO COMPELLING WE HAVE THESE
HIGH IMPACT JOURNALS PUBLISHING
ON THE ROOT CAUSES OF WHAT USED
TO BE THOUGHT OF AS BIOLOGICAL
DIFFERENCES THAT ARE REALLY
ABOUT RACISM, RIGHT?
SO I GET THAT.
BUT WE KNOW THAT STRESSFUL
SITUATIONS YIELD STRESSING
OUTCOMES AND WE KNOW SO LITTLE
ABOUT STRENGTH-BASED APPROACHES
TO HEALING.
THE RESEARCH, SPECIALLY IN
AMERICAN INDIAN AND ALASKA
NATIVE COMMUNITIES COMPELS US TO
THINK ABOUT MORE STRENGTH
ORIENTED APPROACHES TO HEALING,
AND JUST AS A SMALL EXAMPLE,
VERY PRELIMINARY STUDIES, WE
FIND THAT THE ROLE OF BENEVOLENT
OR POSITIVE CHILDHOOD
EXPERIENCES ACTUALLY OUTSHINE
ADVERSE CHILDHOOD EXPERIENCES
BUT WE'RE NOT MEASURING THEM AND
NOT MEASURING THEM WE ARE
PERHAPS PERPETUATING STIGMA,
CALLING IT STRUCTURAL RACISM,
STILL THE STIGMA STICKS WHEN YOU
SEE KIDS OF COLOR, INDIGINOUS
KIDS, WOMEN NOT DOING AS WELL.
BACK TO MY QUESTION WITH THAT
CONTEXT WHAT SYNERGIES MIGHT
EXIST OR COULD WE CREATE TO
BALANCE PRAGMATISM ARE
REVOLUTIONARY APPROACH TO
ADDRESSING INEQUITIES?
>>HOW DO WE DO PRAGMATISM AND
GET REVOLUTION, WHAT SUSAN WAS
AIMING WITH ARPA-H,
TRANSFORMATIONAL JUMPS WE'VE NOT
BEEN ABLE TO DO.
IF THEY WERE EASY WE WOULDN'T BE
HAVING THIS DISCUSSION.
TO START WITH, ABSOLUTELY.
WE START BY ACTUALLY CREATING
SYNERGIES BETWEEN DIFFERENT
INSTITUTES AND IMPORTANTLY
CREATING SYNERGIES IN THE
STRUCTURES THAT WE HAVE THAT CAN
ACTUALLY SERVE THESE
POPULATIONS.
AND AN ASPECT ON THE BASIS OF
COMMITMENT TO ADVANCE SCIENCE
THAT WILL ADDRESS HEALTH
DISPARITIES IS THE NOTION TO
EMPOWER THOSE POPULATIONS TO
ACTUALLY BE THE ONES THAT COME
UP WITH SOLUTIONS AND THIS IS
PARTICULARLY RELEVANT WITH
AMERICAN INDIANIAN AND ALASKA
NATURE I WAS BECAUSE WE CAN COME
UP WITH THINGS THAT ARE
NONSTARTERS IN THOSE
COMMUNITIES, THIS IS GOING TO BE
ONE OF THE MAIN AREAS OF FOCUS,
HOW DO WE TRAIN OUR RESEARCHERS
FROM THOSE COMMUNITIES, FROM
THOSE GROUPS, THAT HAVE CULTURAL
SENSITIVITY AND UNDERSTANDINGS
TO DEVELOP STRATEGIES THAT
PROVIDE RESILIENCE BUT ALSO CAN
BUFFER VULNERABILITY.
SO WHAT YOU'RE SAYING IS
CORRECT, AND I DO -- LET'S NOT
CREATE REDUNDANCIES WHEN NOT
NECESSARY, LET'S MAXIMIZE
STRATEGIC AND ALSO LET'S EMPOWER
THOSE GROUPS SO THEY ARE ACTIVE
PARTICIPANTS IN THE RESEARCH.
AND LET'S TAKE ADVANTAGE OF THE
AGENCIES LIKE THE ARPA-H THAT'S
COMING IN AND SAYS LET'S DO
SOMETHING BOLD AND HOW CAN WE
PARTNER, BECAUSE THAT'S EXACTLY
WHY WE WANTED SUSAN TO SPEAK
WITH US SO WE'RE AWARE THIS IS
AN OPPORTUNITY.
>>THANK YOU, NORA.
MELISSA, I'M SURE YOU'RE AWARE
OF STACY'S WORK IN ALASKA, USING
A CULTURAL TOOLBOX SHOWING GREAT
SUCCESS, CERTAINLY IN ALCOHOL
USE DISORDERS AND SUBSTANCE USE
DISORDERS.
SO ANY OTHER QUESTIONS?
JEFF, I'M GOING TO ASK ONE MORE
QUESTION OF YOU IN LIGHT OF THIS
CONVERSATION.
IN YOUR STUDIES HAVE YOU STARTED
TO PICK UP ANY DIFFERENCES YOU
COULD ATTRIBUTE IN DIFFERENT
SUBGROUPS, RACES, CULTURES, HAVE
YOU GUYS THOUGHT OF THAT AND
LADIES IN THE PAIN FIELD?
>>SO, WE HAVE -- I WANT TO MAKE
SURE I GIVE THE MOST COMPLETE
ANSWER I CAN.
WE'VE FOCUSED TO DATE MORE A
GENDER DIFFERENCES IN SOME
CASES.
I WILL SAY ACTUALLY I DID HAVE A
STUDENT VERY INTERESTED IN RACE
AS A POTENTIAL MODERATOR OF
EFFECT OF PAIN ON DEMAND FOR
BOTH CANNABIS AND ALCOHOL.
AND THAT BASICALLY TURNED OUT TO
BE SORT OF A NULL THING, IT DID
NOT -- SHE RECRUITED EQUAL
NUMBERS OF BLACK AND WHITE
RESIDENTS OF NORTH CENTRAL
FLORIDA FOR THAT STUDY AND
BASICALLY FOUND VERY SIMILAR
RESULTS IN BOTH.
SYSTEMATICALLY I DON'T KNOW HOW
MUCH IT'S HANG IN THE SUBFIELD
OF SUBSTANCE USE PAIN
INTERACTIONS BUT I DO THINK IT'S
VERY IMPORTANT.
>>OKAY.
WE HAVE 13 MINUTES LEFT OF OUR
OFFICIAL TIME.
WIDE OPEN FOR ANY QUESTIONS.
DOESN'T HAVE TO BE TO OUR
SPEAKERS TODAY.
IS THERE ANYTHING YOU WANT TO
KNOW THAT WE HAVEN'T TOLD YOU SO
FAR OR -- OH, WE DO.
TINA?
>>THIS IS FOR JEFF, IN THE
WEEDS.
I'M INTRIGUED BY THE GENDER
DIFFERENCES IN PAIN AND
WONDERING IF PERCEPTION OF PAIN
OR RESPONSE TO INCREASED USE OF
ALCOHOL VARIES ACROSS THE
MENSTRUAL CYCLE FOR WOMEN?
>>GREAT QUESTION.
MY UNDERSTANDING OF THAT
LITERATURE IS THERE ARE SOME
SMALL EFFECTS OF THE MENSTRUAL
CYCLE ON PAIN RESPONSE AND
EXPERIMENTAL PAIN LITERATURE.
THEY ARE NOT HUGE.
I AM NOT AWARE OF DATA REGARDING
EFFECT OF MENSTRUAL CYCLE OR
ALCOHOL, ANALGESIA AS A
CONSEQUENCE OF MENSTRUAL CYCLE.
>>I WOULDN'T BE SURPRISED,
GIVEN THE DATA ON PRE-MENSTRUAL
SYNDROME AND EVEN POSTPARTUM.
THAT'S NOT THE MENSTRUAL CYCLE
OBVIOUSLY BUT POSTPARTUM I
SUSPECT THERE WOULD BE
DIFFERENCES AS WELL.
>>THAT IS A GREAT IDEA TO LOOK
AT.
WE DO HAVE THAT DATA IN OUR
LARGER STUDY OF 110 FOLKS, WE'LL
BE PARSING THAT OUT, DOING OUR
BEST.
>>WONDERING, JEFF, IF YOU HAD
EXPERIENCE WITH PEOPLE WHO HAVE
MIGRAINES AND CLUSTER HEADACHES
AND THE PAIN THAT THEY HAVE,
WHICH IS CONSIDERED INCREDIBLY
DIFFICULT.
I HAD A SPOUSE WHO WAS
COMPLETELY IMMOBILIZED BY
MIGRAINE HEADACHES.
>>I DO NOT.
WE HAVE NOT RECRUITED FOLKS WITH
MIGRAINE OR CLUSTER HEADACHES
FOR OUR STUDIES.
THERE HAVE BEEN INTERESTING
STUDIES LOOKING AT EFFECTS OF
CANNABIS ON HEADACHE, OVER THE
PAST FIVE TO TEN YEARS.
BUT, NO, NOT IN OUR WORK.
IT'S AN INTERESTING QUESTION.
BUT I CERTAINTY DON'T CONSIDER
MYSELF A HEADACHE EXPERT.
>>SHE WOULD RELATE THAT NONE OF
THE PAIN, CHILDBIRTH OR
ANYTHING, CAME NEAR THAT KIND OF
PAIN.
AND SHE DIDN'T FIND MEDICATIONS
THAT WERE HELPFUL EITHER.
>>THERE'S LOTS OF THINGS WE
DON'T KNOW DESPITE HAVING BEEN
AT NIH AS LONG AS I HAVE, I'M
ALWAYS AMAZED I'M STILL HERE
GIVEN ALL THE PATHOLOGY EACH OF
THE I.C. DIRECTORS BRINGS TO
THE REGULAR MEETINGS.
NORA WANTS TO MAKE A COMMENT AND
A QUESTION.
YOU HAVE A QUESTION.
>>A QUESTION.
IT HAS TO DO WITH SOME OF THE
POINTS BROUGHT UP.
I THINK WHEN JEFF, WHEN YOU WERE
PRESENTING THE DATA, THE
ENORMOUS VARIABILITY, YOU SEE
SIGNIFICANT DIFFERENCES, THERE'S
GIGANTIC DEVIATION.
MY QUESTION IS HAVE YOU DONE
STUDIES IN TERMS OF TEST
REPRODUCIBILITY, PARTICULARLY
TAKING INTO ACCOUNT, FOR
EXAMPLE, POTENTIAL DIFFERENCES
IN CIRCADIAN VARIABILITY, IN
OTHER WORDS ARE WE LESS
SENSITIVE TO PAIN ACTUALLY IN
THE MORNING THAN IN THE EVENING,
AND NUMBER TWO, THE OBVIOUS ONE
WE HAVEN'T DISCUSSED FOR WHICH
THERE'S SIGNIFICANT EVIDENCE OF
DATA, THAT SLEEP ACTUALLY LACK
OF SLEEP IS ASSOCIATED WITH
INCREASED ENHANCED SENSITIVITY
TO PAIN.
PUT THOSE WHO AND TWO TOGETHER,
YOU KNOW ALCOHOL INTERFERES WITH
SLEEP PATTERNS, THIS COULD BE
ONE OF THE FACTORS THAT ACCOUNTS
FOR ACTUALLY EXACERBATION OF
PAIN SENSITIVITY WITH CHRONIC
ALCOHOL AMONG THE MANY OTHERS.
BUT ALSO IT COULD RELATE TO THE
HIGHER DIFFERENCES IN RESPONSE
TO PAIN AMONG THE RACES BECAUSE
IT IS -- AND ETHNICITIES,
BECAUSE IF YOU LOOK AT SLEEP
TIME ACROSS RACES IT'S SHORTER
FOR PEOPLE THAT ARE BLACK, AND
EVEN IN TEENAGERS AND CHILDREN,
THIS IS ONE OF THE CONSEQUENCES
OF LOW INCOME.
HAVE YOU ENTERED INTO ACCOUNT
THE ISSUES OF CIRCADIAN
VARIABILITY, ISSUE OF SLEEP, AND
HOW THIS MAY BE INTERFERING
ULTIMATELY OR AFFECTING
SENSITIVITY TO PAIN?
>>IN OUR EXPERIMENTAL STUDIES
WE HAVEN'T DIRECTLY -- HAVEN'T
MANIPULATED CIRCADIAN PERIOD,
ALMOST EVERYBODY IS GETTING
THEIR ALCOHOL DOSE RIGHT AROUND
12:00, 1:00 IN THE AFTERNOON FOR
FEASIBILITY REASONS SO WE'RE
TRYING TO KEEP PEOPLE, YOU KNOW,
WITHIN A TYPICAL RANGE WHERE
THEY MIGHT BE DRINKING BUT NOT
SO LATE THEY HAVE TO STAY IN THE
LAB UNTIL TEN OR ELEVEN AT
NIGHT.
WE HAVEN'T MANIPULATED THAT BUT
THEY SHOULD BE AT ROUGHLY THE
SAME STAGE JUST BECAUSE OF WHEN
THEY ARE COMING IN.
I WILL SAY IN TERMS OF SLEEP, WE
DON'T TYPICALLY ASSESS SLEEP
QUALITY THE NIGHT BEFORE IN
THOSE STUDIES ALTHOUGH WE DO GET
TYPICAL SLEEP QUALITY THROUGH
THE PITTSBURGH SLEEP SCREENER
AND FIND THAT IS RELATED TO PAIN
IN AT LEAST SOME CASES.
IN OUR TREATMENT -- STUDIES IN
TREATMENT SEEKERS, WE DO FIND
VERY STRONG RELATIONSHIPS
BETWEEN THEIR CLINICAL REPORTS
OF PAIN AND THEIR SLEEP QUALITY
FOR SURE.
AND OVER THE COURSE OF EARLY
ABSTINENCE SLEEP QUALITY IS
IMPROVING, PAIN IS GOING DOWN,
CHANGES ARE STRONGLY CONNECTED.
>>AND YOU SHOULD SEE CIRCADIAN
VARIABILITY BECAUSE I BET THERE
IS.
>>THAT WOULD BE INTERESTING.
>>WE'VE GIVEN JEFF ENOUGH TO
FIGHT GRANTS FOR THE REST OF HIS
CAREER AND SUSAN SOME POWERFUL
AREAS WHERE WE SEE DEFICITS IN
THE SUBSTANCE USE DOMAINS.
ANY OTHER QUESTIONS OR COMMENTS?
SOMETHING IN THE CHAT.
ALL RIGHT.
ONE MORE FOR YOU, SUSAN.
HOWARD, CAN YOU TURN ON YOUR
MICROPHONE AND ASK YOUR
QUESTION?
>>SURE.
SO YOU BROUGHT UP THE PROJECT
MANAGERS THAT COME IN WITH THEIR
PASSION AND EXPERIENCE FROM PAST
YEARS, BUT HOW DOES ARPA-H
PROGRAM CONSIDER THE MAJOR
CHANGES THAT ARE GOING ON IN THE
RECENT THREE YEARS, IN THE R&D
COMMUNITY, SO I'M THINKING OF
TWO MAJOR THINGS, ONE IS THE
ONGOING LIMITATIONS OF R&D STAFF
TO CONDUCT TRIALS THAT'S
LIMITING ENROLLMENT AND SUCCESS
OF OTHER PROGRAMS, WHICH
PROBABLY RAISES THE CHALLENGE AS
WELL FOR THESE PHASE 1/2s TO
SUCCEED IN PATENT LIFE AND GET
FURTHER, LET'S SAY, SUPPORT BY
LARGER COMPANIES, AND THEN THE
OTHER IS WHAT'S GOING
REGULATORY COMMUNITY WHERE THE
ACCELERATED PROGRAMS ARE NOW
UNDER CHALLENGE BECAUSE THEY
HAVE NOT REALLY -- MANY HAVE NOT
SUCCEEDED IN GOING ON TO HAVE
SUCCESSFUL PHASE 3 WITHIN THE
TIME RANGE, YOU KNOW, THE
CONFIRMATORY TRIALS HAVE NOT
BEEN DONE.
AND SO THE AGENCY HAS BEEN LET'S
SAY MORE CONSERVATIVE ABOUT, YOU
KNOW, LET'S SAY SUPPORTING THE
ACCELERATED PROGRAMS IF THEY
CAN'T ALSO COINCIDENTALLY ASSURE
THAT THE CONFIRMATORY TRIALS
WILL BE DONE IN TIME.
>>THOSE ARE BOTH HUGE ISSUES.
WE FULLY UNDERSTAND THAT.
ONE OF THE THINGS WE'RE TRYING
TO DO IS THINK ABOUT INNOVATIVE
APPROACHES TO CLINICAL TRIAL
NETWORKS.
I TALKED ABOUT THAT INVESTOR HUB
AND SPOKE MODEL, CUSTOMER
EXPERIENCE HUB AND SPOKE MODEL
THAT WE'RE GOING TO EXECUTE WITH
THE OTHER HUB WE'RE CREATING.
ONE OF OUR GOALS FOR THAT IS TO
THINK ABOUT CREATING OR
REQUIRING THAT HUB AND SPOKE TO
HELP YOU WILLS DEVELOP THESE
CLINICAL TRIAL NETWORKS AND
ENSURE THAT THEY HAVE
APPROPRIATE EQUITY AND DIVERSITY
INCLUDED.
WE KNOW IT'S A HIGH BAR BUT
CERTAINLY THAT'S SOMETHING THAT
IS ON OUR MIND AND WE'RE
THINKING ABOUT.
IN TERMS OF REGULATORY PROCESS,
ALSO YES, BUT IT'S A CHALLENGE.
WE FULLY UNDERSTAND THAT.
ONE OF THE THINGS THAT WE'RE
HAPPY ABOUT IS WHEN CONGRESS,
YOU KNOW, CREATED ARPA-H, IT
ALSO GAVE US THE PERMISSION,
GAVE US AUTHORITY TO WORK
DIRECTLY WITH FDA TO ESTABLISH
CERTAIN PARTNERSHIP COOPERATION
WITH THEM, TO UNDERSTAND HOW DO
WE STRENGTHEN THAT REGULATORY
PROCESS FOR ARPA-H-LED PROGRAMS
AND ACTIVITIES.
AND WE HAVE AN RFI CURRENTLY OUT
ON THE STREETS THAT EVERYONE
HERE CAN ACCESS TO HELP US THINK
THROUGH INNOVATIVE APPROACH TO
OUR RELATIONSHIP WITH FDA AND
THE ACTIVITIES THAT WILL
INTEGRATE WITHIN ARPA-H PROGRAM
DEVELOPMENT AND
COMMERCIALIZATION.
SO THOSE ARE HARD PROBLEMS THAT
WE FULLY UNDERSTAND ARE IN THE
R&D.
WE'VE THINKING ABOUT APPROACHES
TO TRY TO ADDRESS THEM AND
MITIGATE THAT PART OF THE RISK
OF OUR PORTFOLIO.
IF ANYONE'S INTERESTED IN
CONTRIBUTING TO THAT RFI, YOU
CAN GET ACCESS ON OUR WEBSITE.
IT CLOSES ON MAY 30 SO YOU HAVE
A LITTLE BIT OF TIME TO
CONTRIBUTE IF YOU HAVE ANY
OPPORTUNITIES OR INSIGHT FOR
INNOVATION THAT WE SHOULD
CONSIDER AS WE GO ABOUT OUR
RELATIONSHIP WITH FDA.
>>IT HAS BEEN -- I'M NOT A POET
LIKE SHELLY IS.
IT'S BEEN A LONG DAY.
WONDERFUL DAY.
I SEE THAT ABOUT 60 PEOPLE HAVE
STUCK WITH US THROUGHOUT THE
WHOLE DAY TODAY ON ZOOM.
I WANT TO THANK OUR SPEAKERS,
JEFF BOISSONEAULT AND SUSAN
MINAREZ, FOR OUTSTANDING TALKS
AND WILLINGNESS TO STICK IT OUT
WITH OUR QUESTIONS.
AND SO WE'LL CALL -- NO, I DON'T
DO IT.
NORA CALLS OUT THE ADJOURNMENT.
I'LL STOP TALKING.
>>WE'VE BEEN GIVEN THIS SHEET
THAT TELLS WHICH PERFORMS WHAT
AT WHAT TIME.
THAT'S THE ISSUE.
GEORGE TENDS TO FORGET.
HEY, GEORGE!
>>STARTS RATTLING THE PAPERS.
>>I DON'T.
I JUST SAY LOOK AT THE REPORT.
IT'S A PLEASURE TO DOCUMENT THE
INTEREST AND HOW WE BOTH
RESONATE ON THE SAME ISSUES
WHICH HAPPENS ALL THE TIME.
I PARTICULARLY DO WANT TO THANK
YOU ALL THAT HAVE BEEN
PARTICIPATING, EITHER AS MEMBERS
OF COUNCILS OR AS PRESENTERS OR
PEOPLE THAT ARE NOT EVEN PART OF
COUNCIL THAT ARE IN OUR STAFF
AND SINCE THIS IS OPEN FOR
PEOPLE THAT MAY NOT BE PART OF
THE GOVERNMENT, BECAUSE WE
ACKNOWLEDGE THAT WE DO HAVE A
RESPONSIBILITY TO TRY TO ADDRESS
A VERY CHALLENGING PROBLEM THAT
ACTUALLY IS FACING US IN MANY
WAYS.
IN ORDER FOR US TO BE CREATIVE
WE NEED HAVE THE VARIOUS
PERSPECTIVES.
I VERY MUCH THANK YOU FOR THAT.
BUT I ALSO VERY MUCH WANT TO
ACKNOWLEDGE EFFORTS THAT MADE
THIS POSSIBLE AND IN PARTICULAR
DR. PAULETTE GRAY
EXECUTIVE SECRETARY FOR NATIONAL
CANCER ADVISORY BOARD, THE NCI
COMMITTEE OFFICE AND NATIONAL
INSTITUTES OF ALCOHOL ABUSE AND
NIDA COUNCIL MEMBERS.
AND EVERYBODY THAT HELPED MAKE
THIS POSSIBLE.
SO THANKS VERY MUCH.
AND EVEN THOUGH WE'RE GOING TO
BE ADJOURNING, WE ARE OPEN
INSTITUTES, SEND YOUR COMMENTS
OR SUGGESTIONS AND WE'LL ADDRESS
THEM.
THANKS VERY MUCH.
WE ARE ADJOURNED.