>>WELCOME, EVERYONE.
I WOULD LIKE TO WELCOME YOU TO
THE 162nd MEETING OF THE
NATIONAL ADVISORY COUNCIL ON
ALCOHOL AND ALCOHOLISM.
TO THE FIRST THING WE'LL DO IS
HAVE EACH OF YOU INTRODUCE
YOURSELVES.
WE'LL GO IN ALPHABETICAL ORDER
ANNOUNCE YOUR NAME AND
INSTITUTION AND ONE LINE ABOUT
YOUR EXPERTISE.
YOU DON'T HAVE TO BE SHY.
DR. NANCY BARNETT.
>>WE CAN GET BACK TO HER --
>>I'M HERE.
>>OKAY.
>>I KNEW I'D BE FIRST.
HI, NANCY BARNETT.
I'M AT BROWN UNIVERSITY AT THE
DEPARTMENT OF BEHAVIORAL AND
SOCIAL SCIENCES IN THE SCHOOL OF
PUBLIC HEALTH AND MY PRIMARY
AREAS OF RESEARCH ARE EMERGING
ADULTS AND COLLEGE STUDENTS AND
THEIR PROBLEMS THEY HAVE AND THE
INTERVENTIONS THAT SEEM TO WORK
INCLUDING I LIKE TO USE REMOTE
MONITORING INCLUDING SENSORS AND
I STUDY SOCIAL NETWORKS AND
BYSTANDER INTERVENTION TO ARE
REDUCE THE HARMS ASSOCIATED WITH
ALCOHOL USE.
>>AND
>>NANCY IS GOING TO TALK ABOUT
SOME OF HER WORK THIS AFTERNOON.
DR. JILL BECKER.
>>I'M JILL BECKER FROM THE
UNIVERSITY OF MICHIGAN.
I'M IN THE DEPARTMENT OF
PSYCHOLOGY AND THE MICHIGAN
NEUROSCIENCE INSTITUTE.
I STUDY SEX DIFFERENCES IN
ADDICTION AND MOTIVATION USING
ANIMAL MODELS.
>>DR. ANDREW CAMERON.
>>I'M AT JOHNS HOPKINS IN
BALTIMORE A MEMBER OF THE
DEPARTMENT OF SURGERY AND LIVER
TRANSPLANT SURGEON THERE AND
WE'RE INTERESTED IN LOOKING AT
THE USE OF LIVER TRANSPLANT AS A
THERAPEUTIC INTERVENTION FOR
SEVERE ALCOHOL HEPATITIS.
>>THANKS.
>>I'M CHRIS CARPENTER AN
ECONOMIST AT VANDERBILT
UNIVERSITY AND STUDY PUBLIC
POLICY AND WE'RE FOLKS.
-- QUEER FOLKS.
>>DR. CHAMBERS.
>>SHE'S NOT ONLINE.
>>WE'LL CATCH HER LATER.
DR. CLARK.
>>ALSO I'LL REACH OUT AND SEE
IF WE CAN GET HIM.
>>OKAY.
DR. NANCY GONZALEZ.
>>NANCY IS ALSO NOT ONLINE.
I'LL REACH OUT TO HER.
>>DR. CONSTANCE HORGAN.
>>HI THERE.
CONNIE HORGAN THE DIRECTOR OF
THE INSTITUTE FOR BEHAVIORAL
INSTITUTE AT THE HELLER SCHOOL
AT BRANDEIS UNIVERSITY.
I'M A HEALTH SERVICES RESEARCHER
AND MY RESEARCH FOCUSES ON
ALCOHOL SERVICES AND HOW TO
BETTER INCORPORATE THE DELIVERY
OF THOSE SERVICES.
>>DR. RHONDA JONES-WEBB.
>>I'LL REACH OUT TO HER ALSO.
>>MS. BETH KANE-DAVIDSON.
>>HOO HAPPY NEW YEAR.
I'M THE DIRECTOR OF SUBURBAN
HOSPITALS JOHNS HOPKINS
TREATMENT CENTER AND DIRECT
CAREER GIVER IN DEVELOPMENT OF
PROGRAMS.
>>DR. DAVID KERICKAN.
>>PROFESSOR AND VICE CHAIR FOR
RESEARCH AND NEUROLOGY AT THE
INDIANA UNIVERSITY SCHOOL OF
MEDICINE AND DIRECTOR OF THE
ALCOHOL RESEARCH CENTER,
CLINICAL NEUROPSYCHOLOGIST BY
TRAINING AND MY RESEARCH USES
FUNCTIONAL BRAIN IMAGING TO
EXAMINE RISK IN YOUNG ADULTS.
>>THANKS.
DR. CHARLES LANG.
>>I'M A PROFESSOR OF PSYCHIATRY
AND PSYCHOLOGY AT THE UNIVERSITY
OF WASHINGTON.
MOST MY WORK IS ETIOLOGY AND
PREVENTION FOR ALCOHOL USE
DISORDERS AND RELATED COMORBID
MENTAL HEALTH CONDITIONS
PRIMARILY IN YOUNG ADULT
POPULATIONS.
>>THANKS, MARY.
DR. MICHAEL LEWIS.
>>I'M PROFESSOR OF PSYCHOLOGY
IN THE DEPARTMENT PSYCHOLOGY AT
THE GRADUATE CENTER.
I'M A BEHAVIORAL NEURAL
SCIENTIST AND INTERESTED IN
REINFORCEMENT AND MECHANISMS
INVOLVED WITH CONTROLLING
INTAKE.
I'M PARTICULARLY INTERESTED IN
THE INTERACTION OF FOOD INTAKE
AND NUTRITION AND ALCOHOL.
>>THANKS.
DR. LAURA NAGY.
>>I'M INTERESTED IN
[INDISCERNIBLE] CONTRIBUTIONS TO
ALCOHOL ASSOCIATED LIVER
DISEASE.
>>THANKS, LAW ARE.
-- THANKS, LAURA.
>>DR. LAURA O'DELL.
>>I'M THE SECOND LAURA.
NICE TO SEE EVERYONE.
I'M A PROFESSOR AT THE
UNIVERSITY OF TEXAS AT EL PASO
AND ASSOCIATE V.P. OF RESEARCH.
MY RESEARCH FOCUSES ON RODENT
MODELS TO STUDY NICOTINE USE IN
VULNERABLE POPULATIONS.
>>THANKS, LAURA.
AND DR. SCOTT RUSSO.
>>GEORGE, THANK YOU.
I'M A PROFESSOR OF NEUROSCIENCE
AT MOUNT SINAI AND DIRECTOR OF
THE BRAIN AND BODY RESEARCH
CENTER.
THE MAJOR FOCUS OF MY WORK IS TO
EXAMINE THE IMPACTS OF STRESSORS
PARTICULARLY TRAUMATIC STRESS ON
IMMUNE BRAIN INTERACTIONS AT
PHYSICAL BORDERS WITHIN THE BODY
AND IT'S RELATION TO DISEASE.
>>DR. KATIE WITKIEWITZ.
>>MY WORK IS FOCUSSED ON
BEHAVIORAL TREATMENT FOR ALCOHOL
USE DISORDER AND RECOVERY AND
PRECISION MEDICINE APPROACHES
AND UNDERSTANDING BETTER WHICH
MEDICATION OR TREATMENTS WORK
FOR INDIVIDUALS WITH ALCOHOL USE
DISORDER.
GREAT TO BE HERE.
>>AND DR. CHARLES ARE YOU ON?
>>HE'S NOT ON BUT DR. LANG HAS
JOINED.
HE HAS MUTED.
>>CHARLES, CAN YOU UNMUTE.
>>WE'LL CONTINUE.
I'D LIKE YOU TO SHARE THOUGHTS
AND EXPERIENCES AS TENURE AS
COUNCIL MEMBERS AND MAYBE GIVE
US THOUGHTS WHERE NIAAA SHOULD
BE GOING --
>>WE NEED TO KEEP GOING FOR THE
AGENDA.
>>I'M THE DIRECTOR OF THE
NATIONAL ADVISORY COUNCIL ON
ALCOHOL AND ALCOHOLISM AND I'D
LIKE TRISH AND VICKY AND BRIDGET
TO INTRODUCE THEMSELVES AND I'LL
TAKE IT FROM THERE TO ALERT THE
OTHERS AND TRISH, VICKY AND
BRIDGET.
>>I'M THE DEPUTY DIRECTOR AT
NIAAA.
>>I'M VICKY BUCKLEY DEPUTY
ETHICS COUNSELOR FOR NIAAA.
>>HI, I'M BRIDGET WILLIAMS
SIMMONS IN THE OFFICE SCIENCE
POLICY AT NIAAA AND THE
ASSOCIATE DIRECTOR FOR BASIC
RESEARCH.
THANK YOU.
>>AND THEN DAVID GOLDMAN AND
DAVID LOVINGER.
>>I'M DAVID GOLDMAN THE
CLINICAL DIRECTOR AND
GENETICIST.
I HAVE THE OF ORGANIZING THIS
2022 BFC WITH AREAS TO WIC.
>>I'M THE ACTING SCIENTIFIC
DIRECTOR OF THE DIVISION OF
INTRAMURAL AND BIOLOGICAL AND
CLINICAL RESEARCH.
HELLO.
>>YOU'LL HEAR A LOT ABOUT
DAVID.
>>PHILIPPE WOULD YOU LIKE TO
INTRODUCE YOURSELF AND YOUR
POSITION.
>>I'M THE ACTING DIRECTOR OF
EXTRAMURAL ACTIVITIES AT NIAAA.
>>I'M THE ACTING EXECUTIVE
SECRETARY FOR NC NATION COUNCIL
OF ALCOHOLISM AND ABUSE AND
CHIEF OF THE PLANT AT THE NIAAA.
>>HELLO, I'M CATHY YOUNG.
I'M THE DIRECTOR OF THE DIVISION
OF METABOLISM AND HEALTH EFFECTS
AT NIAAA THE DIVISION THAT
OVERSEES ALCOHOL ORGAN DAMAGE.
>>I'M AND THE -- I'M THE
DIRECTOR OF NEUROSCIENCE AND
BEHAVIOR.
WE DO A LOT OF STUFF ALSO IN
TERMS OF GENETICS, GENOMICS AND
THE LIKE.
WELCOME TO EVERYONE.
>>HELLO.
I'M RAY LITTON, DIRECTOR OF THE
DIVISION OF TREATMENT AND
RECOVERY.
>>I'M THE DIRECTOR EPIDEMIOLOGY
AND RESEARCH AT NIAAA.
>>PONG
>>
>>NOBODY HAS SIGNED ON AND WE
CAN PROBABLY INTRODUCE THEM
DURING THE LATER SPOT OF THE DAY
WHEN WE HAVE RETIRING MEMBERS
TALK.
>>SO WHAT ARE WHERE HE MOVING
TO NEXT THEN?
>>NOW WE'RE GOING START WITH
YOUR REPORT.
>>OKAY.
WE'LL DO THE RETIREMENT -- SO
HAVE YOU PLENTY OF TIME TO THINK
ABOUT WHAT I ASKED EARLIER THE
THREE OF YOU THAT ARE RETIRING
AND WE'LL CATCH YOU AFTER MY
DIRECTOR'S REPORT.
WE'LL MOVE TO THE DIRECTOR'S
REPORT.
EVERYTHING WITH SOUND AND
HEARING AND SLIDES?
>>YES, SLIDES ARE FINE.
SOUND IS GREAT.
>>SO THIS IS MY REPORT ON
INSTITUTE ACTIVITIES FOR THE
162nd MEETING OF THE NATIONAL
ADVISORY COUNCIL ON ALCOHOL AND
ALCOHO
ALCOHOLISM.
SO EVERYBODY WANTS TO KNOW ABOUT
THE BUDGET.
ON DECEMBER 29, 2022 THE
PRESIDENT SIGNED THE
CONSOLIDATED APPROPRIATIONS ACT
OF 2023.
NIH RECEIVED A TOTAL OF $47.7
BILLION.
$2.5 BILLION OR 5.5% INCREASE
ABOVE FISCAL YEAR 2022 ENACTED
LIVELY.
NIAAA RECEIVED $95.3 MILLION.
THIS REPRESENTS AN APPROXIMATELY
$22 MILLION OR 3.8% INCREASE
OVER FISCAL YEAR 2022.
WE ESTIMATE WE'RE GOING TO BE
SUPPORTING ABOUT 728 RESEARCH
PROJECT GRANTS THIS FISCAL YEAR.
THE APPROPRIATION OF THE FISCAL
YEAR 2024 PRESIDENT'S BUDGET IS
UNDERWAY.
THAT'S BASICALLY ALL WE HAVE TO
REPORT ON THE BUDGET.
AS YOU KNOW THERE'S THE
PRESIDENT'S BUDGET, HOUSE'S
BUDGET AND SENATE'S BUDGET AND
THEY'LL ULTIMATELY COME TOGETHER
TO BE OUR FINAL BUDGET FOR 2024.
AND HAD SPECIAL EMPHASIS PANELS
AND ALL GRANT MANAGEMENT
ACTIVITIES.
ABE ACTED AS THE EXECUTIVE
SECRETARY OF NIAAA AND
RESPONSIBLE FOR OVERSEEING
COMMITTEE MANAGEMENT ACTIVITIES
INCLUDING FEDERAL ADVISORY
COMMITTEES.
IN HIS RETIREMENT ABE SAID HE
LOOKED FORWARD TO EXPANDING HIS
TRAVELS AND FINDING OTHER
EXCITING WAYS TO FILL HIS DAYS.
HE'LL BE VERY MISSED VERY MUCH
SO.
AS YOU KNOW, PHILIPPE HAS STEP
YOU TO BE ACTING OEA DIRECTOR
AND WE'LL BEGIN A SEARCH FOR A
PERMANENT APPOINTEE TO THE
POSITION IN THE NEAR FUTURE.
THERE'S A RUMOR THAT HE MAY
APPEAR AT A MEETING FROM TIME TO
TIME.
IF YOU MISS HIM LIKE I DO
ESPECIALLY IF THE MEETING IS
HELD IN LOUISIANA.
THAT MAY BE A DRAWING POINT FOR
ABE AND HE'S DONE A GREAT JOB
FOR NIAAA AND HONOR AND
APPRECIATE HIM.
AS I SAID WE'RE IN THE EARLY
STAGES OF THE RECRUITMENT
PROCESS AND ANTICIPATE
COMPLETING THE PROCESS IN THE
NEXT FEW MONTHS FOR DIRECTOR OF
THE OFFICE OF EXTRAMURAL
ACTIVITIES.
AS I ALREADY EXPLAINED TO YOU
ALL IN THE CLOSED SESSION, WE
ARE IN THE PROCESS OF RECRUITING
A SCIENTIFIC DIRECTOR FOR OUR
INTRAMURAL RESEARCH PROGRAM AND
EACH CANDIDATE HAS GIVEN A TALK
ABOUT THEIR RESEARCH AS WELL AS
THE VISION FOR THE INTRAMURAL
PROGRAM WE SOLICITED FEEDBACK
FROM ALL OF STAFF AND AFTER A
FINAL INTERVIEW STAGE WE HOPE TO
MAKE A SELECTION IN THE NEXT FEW
WEEKS.
AND THEN WE WERE ALSO RECRUITING
A SCIENTIFIC DIVERSITY OFFICER
AND RECRUITING FOR THIS POSITION
AND ANTICIPATE THE OFFICIAL
ANNOUNCEMENT WILL OPEN IN THE
NEXT FEW WEEKS.
WE WELCOME YOUR HELP IN ALL OF
THESE RECRUITMENTS.
IF YOU FEEL LIKE THERE'S A
CANDIDATE THAT WOULD MATCH THE
JOB ANNOUNCEMENT, PLEASE SEND
THE INFORMATION TO THEM.
YOU ARE, AGAIN AS COUNCIL
MEMBERS ARE AMBASSADORS TO THE
REAL WORLD, HELP US OUT WITH
THIS IF YOU CAN.
THERE'S A NUMBER OF FUNDING
OPPORTUNITIES YOU CAN LOOK IN
THE DIRECTOR'S REPORT FOR A
COMPLETE LISTING.
I'LL HIGHLIGHT A FEW RESEARCH
OPPORTUNITIES FOR NEW AND
AT-RISK INVESTIGATORS TO PROMOTE
WORKFORCE DIVERSITY, WE'RE
PARTICIPATING A FUNDING
OPPORTUNITY ANNOUNCEMENT TO
SUPPORT RO1 GRANT APPLICATIONS
FROM NEW INVESTIGATORS AND
AT-RISK INVESTIGATORS FROM
DIVERSE BACKGROUNDS INCLUDE
THOSE IN THE HEALTH-RELATED
SCIENCES.
HERE'S THE CONTACT.
I WANTED TO MENTION NIH DATA
MANAGEMENT AND SHARING POLICY IS
IN EFFECT.
ALL OF YOU WHO HAVE GRANTS FROM
NIAAA ABOUT THIS AND THE FINAL
NIH POLICY AND SHARING WENT INTO
EFFECT.
THE POLICY PROMOTES TRANSPARENCY
AND ACCOUNTABILITY BY SETTING A
MINIMUM SET OF EXPECTATIONS FOR
DATA MANAGEMENT AND SHARING.
THE DATA SHOULD BE SHARED NO
LATER THAN THE TIME OF AN
ASSOCIATED PUBLICATION OR END OF
THE AWARD PERIOD.
IT'S A GREAT IDEA TO AFFECT AND
SPAWNING INTO OUR CONSORTIA A
GREAT DEAL OF INTEREST AND DATA
MINING AND HARMONIZING AND
UTILIZE AND CAPITALIZE ON
COORDINATED EFFORTS.
AND THE DIRECTOR OF THE NATIONAL
INSTITUTE ON DRUG ABUSE,
DR. NORA VOLKOW AND THE DIRECTOR
OF THE NATIONAL INSTITUTE ON
MENTAL HEALTH DR. JOSH GORDON.
IN ADDITION TO HIGHLIGHTS THE
IMPORTANCE OF REDUCING STIGMA
AND OTHER HEALTH BARRIERS, A
CONFERENCE FEATURED PANEL
SESSIONS COVERING A WIDE RANGE
OF TOPICS INCLUDING OVERVIEW OF
HARMFUL ALCOHOL AND OTHER
SUBSTANCE USE IN WOMEN AND
ADOLESCENT GIRLS, MODEL PROGRAMS
FOR MOTHERS WITH ALCOHOL USE
DISORDER AND OTHER SUBSTANCE USE
DISORDER AND CHILDREN WITH
PRENATE SUBSTANCE DISORDER.
WE ALSO HAD A FORUM ON COVID-19
RESEARCH.
LAST MONTH WE HAD A FORUM WITH
NIAAA SUPPORTED GRANTEES
CONDUCTING COVID-RELATED
RESEARCH.
AND IMPACTS OF COVID-19 STRESS
ON ALCOHOL CONSUMPTION AND NEURO
VULNERABLES AND AFFECTS OF
COVID-19 AND ALCOHOL RELATED
OUTCOMES AND HIV/AIDS AND OTHER
FACTORS AND HEALTH SERVICES.
ONE OF THE -- THERE WERE MANY
THINGS THAT CAME OUT OF THIS,
SOME NEW AND SOME POTENTIALLY
INTERESTING.
AND MANY WORKS IN PROGRESS.
WE LOOK FORWARD TO AN UPDATE IN
A YEAR OR TWO ON FURTHER
PROGRESS IN THIS DOMAIN.
YOU'LL REMEMBER WE PUBLISHED A
PAPER SHOWING THERE WAS A 25%
INCREASE IN ALCOHOL-RELATED
DEATHS IN THE FIRST YEAR OF THE
PANDEMIC.
THAT HAS BEEN SUSTAINED IN THE
SECOND YEAR AND INCREASED A BIT
FURTHER.
AND THE FACTOR JUMPED FROM 2019
AND ANOTHER PERCENT IN 2021.
WE'LL BE FOLLOWING THIS AS
ALWAYS IT POINTS TO THE FACT
THAT WE BELIEVE AND WE CAN SHINE
A LIGHT ON SUBSET OF DRINKING
WHICH IS DRINK TO COPE WITH
STRESS AND TRAUMA TO SOCIETY
THERE'LL BE A TAIL ASSOCIATED
WITH THE PANDEMIC THAT MAY GO ON
FOR SOME TIME.
ONE OF OUR EFFORTS AT NIAAA IS
TO BE PREPARED FOR HELPING
PEOPLE AS BEST WE CAN IN THE
POST-PANDEMIC PERIOD.
THIS HAS BEEN FUN, I HAVE TO
SAY.
THERE'S PROBABLY A COUPLE PEOPLE
AT NIAAA THAT CAN'T IMAGINE THIS
WAS FUN BUT WE PARTICIPATED IN
MORE THAN 60 -- NOT KIDDING,
MEETING, INTERVIEWS IN JANUARY
AND SATELLITE MEDIA TOUR WHICH
DISCUSSED BEHAVIORS DURING THE
HOLIDAYS THAT MAY SHOW SIGNS OF
PROBLEMS WITH ALCOHOL AND DRY
JANUARY.
THE SATELLITE MEDIA TOUR WHICH I
DID INCLUDED 17 OUTLETS AND A
REACH OF 1.8 MILLION PEOPLE.
IT FAILED TO REFLECT A CULTURE
CHANGE.
A GREAT DEAL MORE INTEREST IN
HEALTHY LIFE STYLES AND PERHAPS
THE ROLE OF ALCOHOL IN NOT SO
HEALTHY LIFESTYLE.
THIS IS SOMETHING WE'RE
UTILIZING IN SOME WAYS TO GET
THE WORD OUT ABOUT SOME OF THE
PROBLEMS ASSOCIATED WITH
UNHEALTHY DRINKING.
MOST OF YOU ARE AWARE OF THE
PROFESSIONAL CORPS RESEARCH ON
ALCOHOL AND WE HAD A COUNCIL ON
THIS.
WE CONTINUE TO PROMOTE THE HPCR.
THERE'S RECOMMENDED EDUCATIONAL
ACTIVITY.
AND DESIGNATED BY THE AMERICAN
BOARD OF ADDICTION MEDICINE WE
HOSTED A WEBINAR IN DECEMBER
2022 THAT INCLUDED A DISCUSSION
ABOUT HOW THE HPCR AND SUPPORT
PEOPLE IN RECOVERY AND OTHER
COLLABORATORS HAVE REALLY DONE A
GREAT JOB IN THIS WEBINAR.
I'LL URGE YOU AS I URGED YOU
BEFORE TO PASS THE WORD.
I DON'T CARE WHETHER YOU DO
APPLIED OR CLINICAL RESEARCH OR
BASIC RESEARCH THERE'S
INFORMATION FOR EVERYONE AND
GREAT FOR TEACHING IN ACADEMIC
ENVIRONMENTS.
THERE'S A LOT OF RESOURCES AND
REFERSES YOU CAN USE FOR
TEACHING AND GENERATING SLIDES
FOR ANY TALKS YOU WANT TO GIVE.
WE AIM FOR PRIMARY CARE DOCTORS
BUT I FEEL THE HPCR CAN BE
USEFUL FOR ALL THE PUBLIC THAT
ARE INTERESTED AN HAVE QUESTIONS
ABOUT ALCOHOL.
I WANT TO TALK ABOUT RESEARCH
HIGHLIGHTS AND THE FIRST IS
NARCISSISTIC SO WE'LL GO TO THE
NEXT SLIDE.
THE STAFF SCIENTIST IN THE
LONGEST NAMED LABORATORY IN THE
HISTORY OF THE INTRAMURAL
PROGRAM THE CLINICAL, PSYCHO
NEURAL NEUROCLINOLOGY SECTION
AND IT'S A JOINT SECTION BETWEEN
NIDA AND NIAAA.
MY LABORATORY AT NIDA ALSO
PARTICIPATED IN THIS STUDY FOR
FULL DISCLOSURE.
WE NOTICED IN THE PAST COUPLE OF
YEARS THAT CERTAINLY THERE'S A
ROLE IN ALCOHOL USE DISORDER.
OUR FOCUS HAS BEEN ON CORTICOID
RECEPTOR AND RECEPTOR AND
THERE'S A RESPONSE IN BLOOD
PRESSURE AND THE ALCOHOL USE
DISORDER DATA CAME FROM MONKEYS
AND RODENTS SHOWING THERE WAS AN
INTERESTING DECREASE -- INCREASE
IN ALDOSTERONE THAT CORRELATED
WITH CRAVING AND ANXIETY AND A
STAFF SCIENTIST NOTED THAT THERE
IS AN FDA MINERAL CORTICOID AND
WE EMBARKED ON PRECLINICAL
STUDIES.
AND A RECEPTOR CORTICOID COULD
HELP IN ALCOHOL USE DISORDER AND
IN RODENT INDEPENDENT AND
NON-DEPENDENT ANIMALS IT
ADDRESSED ALCOHOL AND ALCOHOL
INTAKE.
WE SAW THIS IN ANOTHER MOUSE
MODEL DRINKING IN THE DARK AND
SEEMS TO BE SELECTIVE FOR
ALCOHOL.
THIS IS MORE FASCINATING BECAUSE
I'M A BASIC RESEARCHER AND THIS
IS A CLINICAL STUDY.
AND WE DID WE'RE CALLING A
PHARMACOEPIDEMIOLOGY STUDY AND
THEY IDENTIFIED A POSITIVE
INTERACTION WITH THIS AND
U.S. U.S. DEPARTMENT OF VETERANS
AFFAIRS ELECTRONIC HEALTH RECORD
DATA THEY FOUND PEOPLE EXPOSED
AND 34,000 UNMATCHED CONTROL AND
NOTICE THE CHANGE IN SCORES AT
BASELINE AND FOLLOW-UP AND THERE
WAS A GREATER DECREASE IN
INDIVIDUALS IN AUDIT C SCORES
AND THOSE EXPOSED TO
SPIRONOLACTONE AND THE DOSE
WHICH STARTED AT 50 MILLIGRAMS
PER DAY BUT THE LARGER DOSE
PRODUCED A LOT BIGGER EFFECT.
THIS IS NOT A CLASSIC CLINICAL
TRIAL BUT CAN LEAD AND GENERATE
HYPOTHESES FOR ULTIMATE CLINICAL
TRIALS.
I THINK YOU'LL SEE MORE ACTIVITY
IN THE AREA CERTAINLY.
I MIGHT ADD THE REASON I SPENT
TWO SLIDES ON THIS AND I BELIEVE
THIS PHARMACOEPIDEMIOLOGY
APPROACH CAN BE A GOLD MINE FOR
GENERATING HYPOTHESES AND
SECONDARY ANALYSIS.
ANOTHER PAPER THAT CAUGHT MY
ATTENTION IS FROM DR. MARTINO.
SOME RECOGNIZE THIS FROM THE
LABORATORY AT SAN DIEGO AND
WANTED TO ASK THE ROLE OF
ACETATE IN GUT MICROBIOTA
ASSOCIATED WITH GUT ALCOHOL
CONSUMPTION AND THERE'S
OVERGROWTH THAT OCCURS WITH
UNHEALTHY USE OF ALCOHOL.
ALSO ASSOCIATED WITH LIVER
DISEASE AND TRYING TO IDENTIFY
THE THIS IN LIVER DISEASE AND
POSSIBLY IN ALCOHOL USE DISORDER
AND THE MECHANISM IS NOT WELL
KNOWN.
AND SO SOME OF THE DATA THAT
SUPPORT THIS IN ANIMALS FECAL
SAMPLES WITH ALCOHOLISM WERE
GIVEN TO MICE AND HEALTHY
SUBJECTS ACTUALLY INCREASED THE
SURVIVAL IN ALCOHOL ASSOCIATED
HEPATITIS IN PEOPLE.
THAT'S THE BACKGROUND IN THIS.
WHAT THIS GROUP WANTED TO DO WAS
FIGURE OUT THE ROLE OF ACETATE
AND ALCOHOL HAS IT BROKEN DOWN
TO ACETATE BIY ACETATE -- BY AL
DEHYDROGENATE AND IT'S GOING IN
THE INTESTINE WHERE IT PROVIDE
AS A SOURCE OF ENERGY FOR
BACTERIAL GROWTH.
THEY PUT THE MICE ON A DIET THAT
PRODUCES BASICALLY ALCOHOL
DEPENDENCE AND THEY FOUND THAT
ANAEROBIC GUT BACTERIA DID NOT
BREAK DOWN THE ETHANOL TO
ACETATE BUT RATHER USED THE
ACETATE FROM GLUCONEO-GENESIS
AND BASICALLY FOUND WHAT WAS
HAPPENING WAS THERE WAS ACETATE
DISSIMULATION FOLLOWING THE
ETHANOL FEEDING AND THIS WAS NOT
CAUSED BY METABOLISM.
THE ACETATE IS BROKEN DOWN IN
THE LIVER AND MOVES TO THE GUT
AND STIMULATES THIS BACTERIAL
SWITCH FROM BACTERIA THAT YOU
GET AN INCREASE AND THERE'S A
SHIFT IN THIS AND WHAT THEY ALSO
DID WAS THEY CONFIRMED THIS WAS
CAUSING THE SHIFT OF BACTERIAL
GROWTH IN THE GUT.
THEY TOOK HEALTHY ANIMALS AND
INTERGASTRICLY INCREASED ACETATE
LEVELS AND REPLICATED THE
ALTERATIONS IN THE GUT
MICROBIOTA FOUND WITH THE DIET.
BASICALLY THE CONCLUSION IS
THERE'S FURTHER WORK IN
UNDERSTANDING HOW THE SHIFT IN
THE GUT MICROBIOTA SHIFTS LIVER
FUNCTION.
IT'S CLEAR THE SOURCE OF ACETATE
IS ACTUALLY BY THE DYSSIMULATION
AND NOT METABOLIZING ALCOHOL.
IT'S A COOL STUDY TO FIGURE OUT
THE ROLE OF MECHANISM IN THE GUT
MICROBIOTA IN LIVER DISEASE AND
POSSIBLY IN ALCOHOL USE DISORDER
ITSELF.
MANY KNOW WE HAVE A BIG ACTIVITY
IN METABOLISM AND HEALTH TO
INTERACT WITH THE LIVER SOCIETY
IN FINDING WAYS TO TREAT
ALCOHOL-ASSOCIATED LIVER DISEASE
AND ALCOHOL USE DISORDER.
WE HOPE THE INTERACTION WILL
CONTINUE AT THE CLINICAL AND
BASIC RESEARCH LEVEL.
>>THIS IS A STUDY FROM THE MAYO
CLINIC.
MANY KNOW RICHARD FOR HIS
PIONEERING WORK.
THERE'S A BACK STORY TO THIS ONE
AS WELL.
AND THIS IS A GENOME WIDE
ASSOCIATION FOR SHOWING CHANGES
IN CIRCULATING FIBROBLAST FACTOR
21 IN PATIENTS WITH ALCOHOL USE
DISORDER.
AND CIRCULATING PLASMA LEVELS OF
FGF21 ASSOCIATED WITH ALCOHOL
AND CHRONIC CONSUMPTION IN THE
PAST AND THAT'S THIS BACKGROUND,
INJECTION OF FD21 REDUCED
ALCOHOL INTAKE IN MICE.
THERE'S ACTUALLY A STORY EARLIER
TO THIS I REMEMBER WHEN THE
PAPER CAME OUT IT WAS A GROUP IN
THE U.K. AND HE BASICALLY SHOWED
THERE WAS IN A GWAS STUDY THE
RECEPTOR SHOWED THERE WAS A SNIP
ASSOCIATED WITH THE RECEPTOR
THAT WAS CORRELATED WITH AND
THEY HYPOTHESIZED FGF21 WAS A
FEEDBACK FROM EXCESSIVE
DRINKING.
THE STUDY WE'RE LOOKING AT NOW
HAS ADDITIONAL GWAS NOT WORKING
ON THE RECEPTOR FOR FGF21 BUT
WORKING ON FGF21 ITSELF.
AND EVALUATE THE FUNCTIONAL ROLE
IN ALCOHOL USE DISORDER.
ONE VARIANT LOCATED ON THE SNH16
GENE WAS ASSOCIATED WITH PLASMA
FGF21 LEVELS AND WITH AUD RISK.
KNOCK DOWN OF THIS SNHG16-FG2
CELLS INCREASED THE CATACOMBING
MECHANISM AND BRAIN ORGANOIDS
WAS BLOCKED BY CLASSIC FDA
APPROVED MEDICATIONS FOR ALCOHOL
USE DISORDER.
THIS SUGGEST THE AXIS COULD BE A
POTENTIAL PHARMACEUTICAL
TREATMENT FOR THE TREATMENT OF
ALCOHOL USE DISORDER.
IN THE LEFT SIDE IN THE PATIENTS
WITH WITH ALCOHOL USE DISORDER
THE LEVELS WERE POSITIVELY
CORRELATED WITH THE NUMBER OF
HEAVY DRINKING DAYS AND THE
BLOOD LEVELS OF GAMMA GUTEMOL
TRANSFERASE.
YOU SEE DRUG TREATMENT INCLUDING
NATREXONE WAS ASSOCIATED WITH
THE CHANGES IN THE ORGANOIDS.
AND FINALLY ON THE RIGHT-HAND
SIDE YOU GET THE FEEDBACK SCHEMA
OUTLINED NOT ONLY THIS STUDY BUT
PREVIOUS STUDIES THAT WERE THE
BACKGROUND.
THE DATA SUGGESTS GENETIC
VARIANT OF SNHG16 CAN REGULATE
FGF21 CONCENTRATIONS DECREASE
EXPRESSION IN ENZYME ACTIVITY,
ALCOHOL WHEN YOU ARE DRINKING IT
STIMULATES FG21 LEVELS BUT THE
RESEARCHERS WHO WORKED IN THIS
AREA SUGGEST THE LEVELS FEEDBACK
IS SHUT OFF ALCOHOL USE.
DYSREGULATION OF THE SHUT OFF
CAN LEAD TO AND CONTRIBUTE TO
ALCOHOL USE DISORDER AND THE
HYPOTHESIS WOULD BE IF YOU CAN
STOP THIS SEQUENCE OF EVENTS YOU
MIGHT BE ABLE TO PROVIDE ANOTHER
TREATMENT FOR ALCOHOL USE
DISORDER.
IT'S REALLY INTRIGUING AND I
THINK THERE'LL BE MORE WORK
TRYING TO APPROVE EXACTLY HOW
THIS FDF WHICH IS A LARGE
MOLECULE IS AFFECTING THESE
CHANGES.
>>THE LAST TWO ARE IN THE
DOMAIN OF TREATMENT AND AFFECTS
OF TREATMENT CAUSED BY THE
PANDEMIC.
AND THIS PARTICULAR STUDY AND A
GROUP LED BY STACY STERLING AT
THE CENTER FOR ADDICTION AND
MENTAL HEALTH IN KAISER
PERMANENTE IN OAKLAND,
CALIFORNIA, THEY INVESTIGATED
THE IMPACT OF COVID-19 PANDEMIC
ON ALCOHOL TREATMENT UTILIZATION
AND POTENTIAL DISPARITIES.
THE INVESTIGATORS ANALYZED
ELECTRONIC HEALTH RECORDS AND
CLAIMS FROM KAISER PERMANENTE
NORTHERN CALIFORNIA FOR ADULTS
WITH ALCOHOL ABUSE PROBLEMS
PRE-COVID-19 AND DEFINED ALCOHOL
USE PROBLEMS AS EXCEEDING THE
DIETARY GUIDELINES OR IN ONE DAY
EXCEEDING REACHING BINGE LEVELS
OF DRINKING AND THEN THEY USE
THE ALLOTMENT FOR ALCOHOL USE
DISORDER AND THERE'S FOUR-FOLDS
OF GREATER ODDS OF TREATMENT OF
ONSET AND WHAT WAS ENCOURAGING
IN MY VIEW AND THEIR VIEW WAS
THIS WAS GREATER AMONG YOUNG
ADULTS.
IF LOOK AT THE TABLE YOU CAN SEE
THERE'S A JUMP FROM 5.9% TO 20%.
THAT WAS DURING PANDEMIC ONSET
AND THERE WERE NO DIFFERENCES
BETWEEN AGE, GROUP, RACE AND
ETHNICITY IN THE TREATMENT
ENGAGEMENT.
SO EVERYONE SEEMED TO BE TAKING
ADVANTAGE OF THIS.
AND THEY LOOKED AT COLLEGE
STUDENTS VIRTUAL AND IN-PERSON
DRINKING CONTEXT DURING THE
COVID-19 PANDEMIC.
ALTHOUGH COLLEGE DRINKING
DECREASED AT THE ONSET THIS
IDENTIFIED MORE NUANCES
INFORMATION AND THE RISK
INFERRED BY EACH CONTEXT.
SECONDARY ANALYSES WERE
PERFORMED ON SCREENING DATA FROM
A LARGE CLINICAL TRIAL ASSESSING
COLLEGE STUDENT DRINKING
INTERVENTIONS, PARTICIPATION,
PARTICIPANTS ACROSS SIX COHORTS
REPORTED ON THE FREQUENCY OF
DRINKING.
WHAT YOU CAN SEE HERE IN THE
GRAPH AND WE PUT ARROWS TO MAKE
THE LINES A LITTLE CLEARER.
THE PROPORTION AND FREQUENCY OF
DRINKING OUTSIDE THE HOME
INCREASED AND WAS MOST
CONSISTEN
CONSISTENTLY DRINKING AT HOME IS
NOT WITHOUT RISK AND IN FACT
DRINKING AT HOME ALONE WAS
ASSOCIATED WITH INCREASED ABUSE
AND DEPENDENCE AND PERSONAL
SOCIAL HANGOVER AND SOCIAL MEDIA
CONSEQUENCES.
EVEN DRINKING AT HOME WITH
OTHERS VIRTUAL LY AND SOCIAL
CONSEQUENCES.
I THINK IT'S FASCINATING BECAUSE
SOCIAL INTERACTION IS WHERE
PEOPLE DRINK A LOT.
THAT WAS ABROGATED INITIALLY IN
THE FIRST FEW MONTHS OF THE
PANDEMIC BUT CAME BACK.
THE PANDEMIC MOVED FORWARD AND
WE DO ALSO KNOW DRINKING ALONE
HAS BEEN HISTORICALLY ASSOCIATED
WITH INCREASED PATHOLOGY.
THAT'S SOMETHING MORE OR LESS
CONFIRMED BY THESE OBSERVATIONS
AS WELL.
SO FUTURE PREVENTION AND
INTERVENTION EFFORTS AND IT MAY
BENEFIT FROM CONSIDERING
APPROACHES SPECIFIC TO DIFFERENT
DRINKING CONTEXT.
I WOULD ARGUE SHOULD INCLUDE
APPROACHES SPECIFIC TO DIFFERENT
DRINKING CONTEXT AND MAYBE
DIFFERENT TREATMENTS AND
DIFFERENT INTERVENTIONS WILL BE
REQUIRED IN THESE DOMAINS.
THE DIVISION DIRECTORS RECOMMEND
SOME OF THE PAPERS I HIGHLIGHT
EVERY TIME.
AND SO THANKS EVERYBODY.
I'M HAPPY TO TAKE QUESTIONS IF
ANYBODY HAS QUESTIONS.
MARY, DID I GIVE YOU JUSTICE TO
YOUR STUDY?
>>YES, THANK YOU.
>>AND I FIND THE LOCKDOWN
FINDING EXCITING.
>>AND I THINK THERE'S A LOT OF
BASIC RESEARCH BECAUSE IT MAY BE
THAT THE TWO RECEPTORS ACTUALLY
INTERACT WITH EACH OTHER AND IN
WAYS WE DID NOT REALIZE BEFORE.
AND SO THAT'S INTRIGUING.
I BELIEVE LORENZO ARE YOU OUT
THERE OR DAVID GOLDMAN?
EITHER OF YOU?
I BELIEVE THEY'RE PLANNING A
CLINICAL TRIAL AND HAS A
PROTOCOL IN FOR THAT, IS THAT
CORRECT, DAVID?
>>YES, IT IS.
THE CLINICAL TRIAL HAS GONE
THROUGH THE SCIENTIFIC REVIEW
COMMITTEE, THE JOINT NIAAA-NIDA
EFFORTS AND SHOULD BE BEFORE THE
IRB RIGHT NOW AND HOPEFULLY
SOON.
THANK YOU, GEORGE.
>>LORENZO AS YOU ALL KNOW HAS A
JOINT APPOINTMENT WITH NIDA AND
NIAAA AND VERY ACTIVE WITH HUMAN
LABORATORY STUDIES.
WE ALSO HAVE THE CAPABILITY OF
RUNNING CLINICAL TRIALS.
WE ALSO HAVE IN OUR DIVISION OF
TREATMENT AND RECOVERY RESEARCH
I THINK MOST OF YOU KNOW WE HAVE
CONTRACT MECHANISM FOR THREE
THINGS AND IF YOU DON'T KNOW
ABOUT THIS, YOU SHOULD KNOW
ABOUT IT.
IT'S KIND OF FIRST COME, FIRST
SERVE AND PRIORITY IS SET UP IF
WE HAD MULTIPLE PEOPLE COMING
FOR REQUESTS.
YOU CAN DO AN ALCOHOL
INTERACTION STUDY IN HUMANS.
I'M TALKING ABOUT HUMAN STUDIES
HERE.
THESE ARE UNDER CONTRACT AND RUN
OUT OF A DIVISION.
YOU CAN REQUEST TO DO A HUMAN
DRUG AND ALCOHOL INTERACTION
STUDY WHICH IS CRITICAL FOR FDA
APPROVAL.
AND GETTING AN IND.
AND I'M SORRY, NOT GETTING AN
IND BECAUSE YOU HAVE TO HAVE
THAT TO DO THAT.
BUT FOR GOING ON TO PHASE II
CLINICAL TRIAL AND WE DO HUMAN
LABORATORY STUDIES.
I THINK WE CAN AVERAGE ONE OR
TWO A YEAR.
WE'VE HAD TWO SUCCESSFUL
CLINICAL TR
CLINICAL TRIALS BIG PHARMA
DENIED TO PICK THEM UP.
ONE WAS A VASE YO PRESSANT
ANTAGONIST THAT SHOWED A
POSITIVE RESULT AND ONE WAS
CHANTIX FOR THE TREATMENT ON
THE MARKET AS A SMOKING
CESSATION MARKET AND IT SEEMS TO
SHOW IT HELPS WITH ALCOHOL AND A
BETA ANTAGONIST AND MODULATING
THE DOPAMINE SYSTEM AS A PARTIAL
AGONIST.
MORE THAN YOU WANTED TO KNOW,
KATIE, I'M SURE.
>>THANK YOU.
ANY OTHER THOUGHTS OR QUESTIONS?
>>IS THERE A LIST OF THE
ARTICLES WE CAN READILY GET AND
PASS ON TO OTHERS?
WITH DIDN'T GET THE DIRECTOR'S
REPORT.
>>THERE ARE TWO REFERENCES AND
THERE'S SOBERG AND SOBERG WAS
2021.
YOU CAN TYPE IN FGF AND SOBERG
AND GUNTER SHULMAN.
>>THANKS.
THAT WAS GREAT.
>>LAURA O'DELL HAS A QUESTION.
>>DO YOU HAVE A QUESTION?
I WAS INTERESTED AND FASCINATING
BY THE RESULTS AND -- THE SPI
SPIRONOLACTONE AND IT SEEMS
THERE'S OTHER USE FOR THE DRUG.
>>IT'S USED WIDELY.
WHEN I PRESENTED THIS TO MY LAB
A FEW WERE ON SPIRONOLACTONE.
YOU MAY WANT TO SPEAK TO THIS
BUT WHAT WE'RE TRYING TO DO BUT
IT TOOK 15 YEARS FOR NALTREXONE
TO BECOME AN FDA MEDICATION FROM
THE DATE THE FIRST ANIMAL STUDY
WAS DONE AND THE FIRST STUDY WAS
DONE IN MONKEYS.
I'M OLD ENOUGH TO REMEMBER ALL
THIS STUFF SO YOU'RE STUCK WITH
ME.
AND THEN THE SECOND PIECE IS
THAT IT TOOK 17 YEARS FOR
ANOTHER TO GO FROM THE FIRST ROW
DON'T STUDY STO BEING APPROVED
AS A MEDICATION FOR ALCOHOL USE
DISORDER.
AND THAT WAS DONE BY STUDYING
MOSTLY FOOD INTAKE IN FRANCE.
MY POINT IS IN LIEU OF WAITING
17 YEARS FOR A NOVEL MEDICATION
TO GET INTO THE CLINIC WE'RE
TRYING TO UTILIZE EXISTING
MEDICATION S THAT MAY BE
HELPFUL.
>>I THINK YOU'RE RIGHTLY RIGHT.
IT COULD BE AN ADVANTAGE AND
DISADVANTAGE BECAUSE THE FDA
APPROVAL FOR THE IND COMES
EASILY.
WE HAVE ALL THE SAFETY DATA.
AND THEY HAD TO REVISE THE
PROTOCOL FOR THE SAFETY STUDIO
AND SOMETIMES AS WITH
NALTREXONE, THE GROWTH COMPANY
IS NOT NECESSARILY SO MOTIVATED
REALLY TO PROMOTE THE DRUG.
LET'S HOPE WITH THIS BEING A NEW
INDICATION FOR SPIRONOLACTONE
AND HOPE THE TRIAL IS POSITIVE.
THANK YOU, GEORGE.
>>THERE'S ALSO LICENSING ISSUES
AND WHETHER THE COMPANY WILL
MAKE MONEY IF IT'S GER ERIC AND
G
GABOPENTON IS NOW AN ADJUNCT FOR
ALCOHOL USE DISORDER AND WE NEED
TO SEE IF WE CAN TEST THE
HYPOTHESIS.
ANY OTHER THOUGHTS OR QUESTIONS?
ALL RIGHT.
I'LL LOOK IN THE CHAT TO SEE IF
ANYTHING CAME UP IN THE CHAT I
NEED TO ANSWER BUT I THINK
PEOPLE HAVE BEEN ANSWERING FOR
EVERYONE.
>>WE HAVE A BREAK SCHEDULED TO
THE NEXT STOP AT 2:45.
WE'LL BE TALKING ABOUT "ALL OF
US" RESEARCH.
IF WE CAN TAKE A BREAK AND COME
BACK --
>>WHEN ARE WE DOING THE
FAREWELL TO OUR COUNCIL MEMBERS?
>>SO AT 2:45 WE HAVE THE TALK
AFTER THAT WE HAVE NANCY'S TALK
AND A CONCEPT CLEARANCE AND THEN
OPEN COUNCIL DISCUSSION AND
AFTER THAT THE LAST ITEM WILL BE
THE END BIDDING FAREWELL TO
RETIRING MEMBERS.
>>OKAY.
I JUST WANT TO MAKE SURE I'M ON
THE SAME PAGE.
ALL RIGHT.
SO I GUESS WE CAN ALL TAKE
ANOTHER BREAK WHICH IS FINE BY
ME.
MAYBE YOU CAN FIND OUT WHERE OUR
ERRANT COUNCIL MEMBERS WENT.
>>I THINK A COUPLE OF US JOINED
BACK.
DR. LANG AND DR. CHAMBERS IS
HERE.
>>ALL RIGHT.
WE HAVE TIME.
CHARLES, DO YOU ANTOF -- DO YOU
WANT TO INTRODUCE YOURSELF AND
THEN CHRISTINA?
>>HI, SORRY I MISSED THE
INTRODUCTION.
I'M CHUCK LANG AND INTERESTED IN
SKELETAL MUSCLE MYOPATHY.
>>AND CHRISTINA.
>>THE OTHER TWO HAVEN'T JOINED
YET.
>>OKAY.
WE HAVE TIME.
>>IF WE RECONVENE AT 2:40 WE
CAN START ON TIME.
>>LET'S ALL COME BACK AT 2:40
DR. GINSBURG SUPPORTS A WIDE
RANGE OF IMPACTFUL DISCOVERIES.
PRIOR TO JOINING ALL OF US HE
WAS FROM GENOMICS AND PRECISION
MEDICINE AT THE DUKE UNIVERSITY
SCHOOL OF MEDICINE WHERE HE
PIONEERED THE DEVELOPMENT OF
NOVEL DIAGNOSTICS IN GENOMICS
AND WAS PROFESSOR OF MEDICINE
AND BIOSTATISTICS AND
BIOINFORMATICS AND BIO
ENGINEERING AND PROFESSOR AT THE
SCHOOL OF NURSING WHERE HE
REMAINS AN ADJUNCT PROFESSOR AND
WAS A MEMBER OF THE HARVARD
MEDICAL SCHOOL FACTORY.
THROUGHOUT HIS CAREER HE'S
DEMONSTRATED A STRONG COMMITMENT
TO INNOVATION WITH WORK SPANNING
ONCOLOGY AND INFECTIOUS
DISEASES, CARDIOVASCULAR DISEASE
AND METABOLIC DISORDERS.
HE'S HELD LEADERSHIP ROLES IN
THE U.S. AND INTERNATIONALLY
SERVING AS CO-CHAIR OF THE
ROUNDTABLE ON GENOMIC AND
PRECISION HEALTH, A FOUNDING
CO-CHAIR OF THE 100K COHORTS
CONSORTIUM AND FOUNDER AND
PRESIDENT OF THE GLOBAL GENOMIC
MEDICINE COLLABORATIVE KNOWN AS
THE GTMC AIMED AT INTERNATIONAL
PARTNERSHIPS TO ADVANCE THE
IMPLEMENTATION OF PRECISION
MEDICINE.
AT NIH HE HAS SERVED ON THE
BOARD OF EXTERNAL EXPORTS AS AN
ADVISORY COUNCIL MEMBER TO THE
NATIONAL HUMAN GENOME RESEARCH
INSTITUTE AND THE NATIONAL
CENTERS FOR ADVANCING
TRANSLATIONAL SCIENCES AND
RECENTLY ON THE ADVISORY COUNCIL
TO THE DIRECTOR.
HE RECEIVED HIS M.D. AND Ph.D.
DEGREES IN BIO PHYSIC FROM
BOSTON UNIVERSITY AND COMPLETED
AN INTERNAL MEDICINE RESIDENCY
AT BETH ISRAEL HOSPITAL IN
BOSTON AND RECEIVED
POST-DOCTORAL TRAINING IN
CLINICAL CARDIOVASCULAR MEDICINE
AT BETH ISRAEL HOSPITAL AND
MOLECULAR BIOLOGY AT CHILDREN'S
HOSPITAL AS A FOUNDATION FELLOW
OF THE AMERICAN HEART
ASSOCIATION.
HE'S HAD A DISTINGUISHED CAREER.
HE'LL TELL US ABOUT POSSIBLE
PARTNERSHIP OPPORTUNITIES FOR
NIAAA WITH THE "ALL OF US"
RESEARCH PROGRAM I'VE BECOME A
FAN OF THE "ALL OF US" RESEARCH
PROGRAM AND IT'S ALL YOURS.
THANK YOU FOR THE KIND
INTRODUCTION.
I'LL TALK ABOUT THE RESEARCH
PROGRAM INDUCING IT TO YOU AND I
WANT TO TELL YOU ABOUT OUR
SCIENTIFIC DIRECTION AND
SPECIFICALLY WHERE THERE'S
EXISTING ACTIVITIES TAKING PLACE
IN OUR PROGRAM WITH THE EXTERNAL
RESEARCH COMMUNITY PRIMARILY
RELEVANT TO NIAAA AND THEN
FINISH UP WITH THE NOTION OF
PARTNERSHIP OPPORTUNITIES AND
SOME OF THE LANES OF WORK WE
MIGHT CONSIDER WORKING TOGETHER.
SO AGAIN, THANK YOU FOR ALLOWING
ME TO BE HERE TODAY.
LET ME START OFF WITH A SYNOPSIS
OF THE PROGRAM AND IT WAS
LAUNCHED REALLY IN 2015 AT THE
STATE OF THE UNION ADDRESS FOR
PRESIDENT OBAMA AND THE
PRECISION MEDICINE INITIATIVE
AND THE VISION AND MISSION
EMANATE FROM THE TIME WHEN THE
NOTION WAS CAN WE CREATE A
PLATFORM THAT WILL ACCELERATE
RESEARCH, ENABLE MEDICAL
BREAKTHROUGHS AND ENHANCE
PRECISION MEDICINE BY BRINGING
FORWARD THE TOOLS AND
DIAGNOSTICS FOR INDIVIDUALIZED
PREVENTION AND TREATMENT AND
CARE FOR ALL OF US AND ALL OF US
IS PURPOSEFUL IN THIS PARTICULAR
BUSINESS STATEMENT BECAUSE IT
REALLY IS MEANT TO REFLECT THE
FULL DIVERSITY OF PEOPLE IN THE
UNITED STATES.
AND WE'RE DOING THIS THROUGH A
VERY DIRECTIONAL PARTNERSHIP
ACTIVITY WITH OUR PARTICIPANTS
ACROSS THE UNITED STATES.
OUR GOAL IS TO DELIVER A
PLATFORM THAT ENABLES RESEARCH
THAT CONTAINS ONE OF THE RICHEST
BIO MEDICAL DATA SETS I'LL TELL
YOU ABOUT IN THE FUTURE AND THAT
SHOULD SERVE AS A MAGNET FOR
MULTIPLE STAKEHOLDERS AT NIH AND
THE INTRAMURAL RESEARCH
COMMUNITY AND EVENTUALLY
INTERNATIONALLY.
OUR GOAL IS TO ENROLL AT LEAST 1
MILLION PEOPLE AND RIGHT ABOUT
300,000 HAVE DATA AND WE'RE IN
TENSIONAL ABOUT DIFFERS --
INTENTIONAL DIVERSITY.
OUR CURRENT PARTICIPANTS ARE
ALMOST 50% IDENTIFIED AS
NON-WHITE WITH RACE AND
ETHNICITY AND 80% ARE FROM
COMMUNITIES THAT HAVE NEVER
PARTICIPATED IN THE PAST IN ANY
BIOMEDICAL RESEARCH PROGRAMS.
YOU CAN SEE OUR RECRUITMENT
SITES IN THE SOUTHWEST HAVE HAD
THE GREATEST SUCCESS IN
ENROLLING PARTICIPANTS BUT WE'RE
ENROLLING PEOPLE FROM EVERY
STATE IN THE UNION DOES YOU SEE
A LARGE SPAINISH SPEAKING
POPULATION.
WE HAVEN'T DONE AS WELL IN THE
ASIAN POPULATIONS BUT WE'RE
TRYING TO AUGMENT OUR ACTIVITIES
IN THAT REGARD.
AND 80% UNDER REPRESENTED IN
BIOMEDICAL RESEARCH, THOSE ARE
FEATURES LIKE INDIVIDUALS WITH
COGNITIVE IMPAIRMENT OR
DISABILITIES OR FROM RURAL
COMMUNITIES OR EVEN PEDIATRIC
AGE GROUPS WHICH WE'RE ABOUT TO
INITIATE ENROLLMENT OF LATER
THIS YEAR.
GEORGE MENTIONED DATA AS PART OF
MY ROLE IN THE PROGRAM.
WE HAD FIVE MAIN DATA STREAMS
RIGHT NOW AND THE LARGEST DATA
SETS IS ON OUR SURVEYS.
WE'VE RELEASED ABOUT SIX
DIFFERENT SURVEYS.
I'LL SHOW YOU DETAIL ON ONES
PARTICULARLY RELEVANT TO NIAAA
IN A FEW MOMENTS.
PHYSICAL MEASURES, BY WHICH I
MEAN BLOOD PRESSURE, HEIGHT,
WAIST CIRCUMFERENCE AND THINGS
WE MAY CAPTURE FROM A
PARTICIPANT AT THE TIME OF
ENR
ENROLLMENT AT A FACE TO FACE
VISIT.
WE HAVE ROUGHLY 260,000 DATA
SETS IN OUR DATABASE AND IN
MARCH WE HAD 165,000
MEASUREMENTS WERE RELEASED IN
MARCH AND COMING SOON WILL BE
THE NEXT RELEASE PROBABLY IN
LATE MARCH OR APRIL OF THIS YEAR
WHERE WE'LL BRING THE TOTAL UP
TO ABOUT 250,000 WHOLE GENOME
SEQUENCES AND 320,000 MAKING IT
THE LARGEST GENOMIC PUBLICLY
ACCESSIBLE GENOMIC DATA SET ON
THE PLANET.
AND WEARABLE DEVICES ARE ANOTHER
PART OF OUR DATA STREAM.
YOU CAN SEE WE HAVE ROUGHLY
13,000 OF OUR PARTICIPANTS HAVE
PROVIDED PHYSICAL ACTIVITY AND
HEART RATE DATA THROUGH FITBITS
AND OTHER WATCH DATA WE'RE
COLLECTING.
BIO SAMPLES.
WE HAVE EVERY PARTICIPANT WE
ASKED TO DONATE A SAMPLE, WE
HAVE ROUGHLY 420,000 BIO SAMPLES
AND SAMPLES FROM 4420,000
PARTICIPANTS IN OUR BIO BANK AND
MAN
MANY ELOQUAT VARIANTS WERE
DETECT HAD HAD NEVER BEEN SEEN
IN PUBLICLY AVAILABLE GENOMIC
DATA SETS.
ILLUSTRATING THERE'S A LOT OF
INFORMATION WE NEED TO GET FROM
THE UNDER REPRESENTS COMMUNITIES
IN GENERAL AND THIS IS ONLY
GOING TO GROW IN POWER TO
UNDERSTAND GENETICS FROM THOSE
POPULATIONS.
ON THE RIGHT SIDE OF THE SLIDE
IS SYNOPSIS OF THE UNIQUE
INTERSECTIONS OF DATA AND THIS
IS A GENOTYPIC DATA SET.
THIS SPEAKS TO THE DIVERSITY TO
THE NUMBERS WE HAVE CURRENT LY
AND WE HAVE DATA RESEARCH
AGREEMENTS IN WHICH OVER OVER
440 INSTITUTIONS AND HAD AN
EMPHASIS ON NON-FOR-PROFIT
INSTITUTIONS AND ACADEMIC AND
HEALTH CARE ORGANIZATIONS WITH
THE SPECIFIC OUTREACH TO
HISTORICALLY BLACK COLLEGES AND
UNIVERSITIES AND
HISPANIC-SERVING INSTITUTIONS.
WE HAVE OVER 3,000 PROJECTS
UNDERWAY AND THIS IS UP TO 120
PUBLICATIONS AS OF THIS WEEK
COMING FROM THE "ALL OF US" DATA
SET.
I MENTIONED DIVERSITY.
WE ARE EMPHASIZING THE DIVERSITY
OF OUR RESEARCH WORKFORCE USING
OUR DATA AND PROUD TO SAY ABOUT
50% OF OUR RESEARCHERS ARE
SELF-IDENTIFIED AS NON-WHITE.
THE RESEARCHER WORK BENCH.
THIS IS A SCREEN SHOT ON THE
LEFT OF WHAT YOU'D SEE GOING TO
THE URL ALL OF US DOT-ORG AND
YOU'LL SEE TILES PUBLICLY
AVAILABLE.
MAYBE HARD TO SEE BUT THEY'RE
E.H.R. DATA AND PHYSICAL MEASURE
DATA AND A VARIETY OF SURVEY
DATA WITH A NUMBER OF ELEMENTS
IN THEM LISTED IN THE NUMBERS
YOU CAN SEE HERE.
THIS IS SOMETHING THAT YOU CAN
USE TODAY.
IT'S PUBLICLY AVAILABLE AND I'LL
SHOW YOU LITTLE MORE ABOUT
PUBLICLY AVAILABLE DATA IN A
SECOND.
ONE OF THE THINGS WE'RE PROUD OF
IN THE WORK BENCH IS THE
FACILITY WITH WHICH INDIVIDUALS
CAN CARRY OUT COMPLEX STUDIES.
I WANTED TO SHOW A QUICK EXAMPLE
OF A STUDY DONE SOME TIME THIS
PAST MONTH BY A POSTDOC AT
NHGRI.
HE WENT TO THE WORK BENCH AIMING
TO DO A STUDY FOR DIABETES
MYELITIS DONE IN MANY TIMES IN
MANY REGIONS OF THE GLOBE OVER
AND OVER BUT THE POINT IF THIS
WERE A GRANT PROPOSAL IT WOULD
HAVE BEEN ONE TO TWO YEARS TO
PRODUCE A GWAS RESULT AND HE
WENT TO OUR WORK SPACE AND
CREATED A COHORT FOR TYPE II
DIABETES THROUGH FEATURES I
WON'T GO INTO THE DETAILS BUT
ILLUSTRATED IN THE FLOW CHART
BELOW AND WAS ABLE TO REFINE THE
COHORT WITH OTHER CLINICAL
FEATURES AND IMPORT THE SCRIPTS
TO RUN A GWAS AND WAS ABLE TO
REPLICATE THE GENETIC VARIATION
THAT'S BEEN SHOWN MANY TIMES AS
ASSOCIATED WITH TYPE II DIABETES
USING A COHORT OF 20,000
PARTICIPANTS AND COMPUTE TIME OF
20 MINUTES AND A COST OF $37.
THAT'S PRETTY REMARKABLE I WOULD
SAY.
I SHOULD MENTION ALL OF OUR WORK
BENCH USERS START OFF WITH A
$300 CLOUD CREDIT.
AN OPPORTUNITY TO DO FIVE TO TEN
GWAS STUDIES.
I THINK THIS IS AN AMAZING --
THIS PARTICULAR PERSON WAS A
GENETICISTS BUT HAD NEVER DONE A
GWAS BEFORE SO IT'S ALSO QUITE
IMPRESSIVE.
I WANT TO SHIFT GEARS OR MOVE TO
A SECTION WHERE I'LL BRIEFLY
DESCRIBE THE ALL OF US
SCIENTIFIC FRAMEWORK AND AREAS
OF RESEARCH ALREADY ONGOING
RELEVANT TO ALCOHOLISM AND
ALCOHOL ABUSE.
THE FIRST SLIDE IS GOING TO BE A
SNAPSHOT OF WHAT WE CALL THE
SCIENTIFIC ROAD MAP OF THE ALL
OF US RESEARCH PROGRAM.
ITS WAS MY CHARGE IN JOINING ALL
OF US A YEAR AGO TO DEVELOP
THIS.
I'M NOT GOING TO GO INTO THE A
LOT OF DETAIL BUT WANT TO GIVE A
FLAVOR OF THE WAY WE THINK OF
THE RESEARCH STRATEGY TO
EVENTUALLY LEAD TO FUNDING
OPPORTUNITIES IN THE NIH AND
INTRAMURAL AND EXTRAMURAL
OPPORTUNITIES AND LOOK AT WAYS
TO ASSESS RISK, DIAGNOSIS AND
EVENTUALLY TREATMENT PAIR DIMES.
-- PARADIGMS.
IT STARTS OFF AND THIS IS THE
FOUNDATIONAL START THE WORK
BENCH WHERE RESEARCHERS COME TO
DO THEIR SCIENCE AND THE DATA
SETS THAT EXIST THERE.
I MENTIONED ALREADY WE HAVE FIVE
MAIN DATA STREAMS, ELECTRONIC
HEALTH REPORTS AND PARTICIPANT
PROVIDED INFORMATION AND BIO
METRIC DATA AND GENOMES.
WE'RE IN THE PROCESS OF DOING A
LARGE SCALE EXPANSION OF OUR
PHENOTYPIC REPERTOIRE USING BIO
SAMPLES TO VARIOUS CLINICAL OR
IMMUNOLOGIC ASSAYS.
A VARIETY OF METABOLOMICS,
PROTEOMICS AND DIGITAL HEALTH.
ONE STRATEGY FOCUS AREA WE ARE
LAUNCHING IS AN EMPHASIS TO
CREATE THE NOVEL TOOLS OUR
RESEARCHERS WILL NEED TO HAVE
AVAILABLE TO THEM TO UTILIZE
THESE HIGH-DIMENSIONAL DATA SETS
THAT HAVE AN IMPORTANT TEMPORAL
ASPECT TO THEM.
ON TOP OF THIS FOUNDATION, WE'RE
CALLING THE DRIVERS AND
EXPOSURES THAT LEAD TO HEALTH
AND DISEASE TRANSITIONS.
A LOT OF THIS CAME FROM THE
REPORT TO THE ADVISORY COMMITTEE
OF THE DIRECTOR ON PRECISION
MEDICINE INITIATIVE WHEN FRANCIS
COLLINS HAD THAT ROLE.
SO LIFESTYLE, WHICH INCLUDES
SUBSTANCES RELEVANT TO THIS
INSTITUTE BUT ALSO THE IMPACT OF
ENVIRONMENT AND SOCIAL
DETERMINATES OF HEALTH.
THE IMPACT OF HEALTH INEQUITIES
AS WELL AS OR GAPS IN HEALTH
EQUITY AND GENETICS AND BIOLOGY
WE VIEW THEM AS FUNDAMENTAL
DRIVERS OF HEALTH AND HOW THEY
INTERACT LEAD TO OTHER FOCUS
AREAS OF THE PROGRAM WHICH ARE
PROMINENT AND RARE HEALTH
CONDITIONS AND MEANT TO ADDRESS
THE CDC'S TOP TEN CAUSES OF
MORBIDITY AND MORTALITY WITH AN
EMPHASIS ON UNDER REPRESENTED
GROUPS AS WELL.
HOW THESE EXPOSURES AND DRIVERS
INFLUENCE MATERNAL AND CHILD
HEALTH OR RESULT IN HEALTHY
AGING ACROSS THE LIFE SPAN AND
THE UPPER RIGHT HAND FOCUS AREA
REFLECTS OUR COMMITMENT TO
RESULTS BACK TO PARTICIPANTS AND
UNDERSTAND THE DOWN STREAM
IMPACT ON INDIVIDUAL AND
POPULATION HEALTH.
AND FINALLY TO FULLY REALIZE
THIS VISION TO WORK CLOSELY WITH
OTHER INSTITUTES AND CENTERS AT
THE NIH AND COMPANIES, PAIRS AND
POLICY MAKERS TO EFFECTIVELY
TRANSLATE THE WORK BENCH
FINDINGS TO TANGIBLE BENEFITS
FOR SOCIETY AND POPULATION
HEALTH.
I KNOW I WENT THROUGH A LOT AND
THERE'S A VERY EXTENSIVE PLAN
BEHIND HIT THIS BUT WANTED TO
GIVE A SENSE OF HOW THE PROGRAM
HAS SHAPED UP.
IF YOU GO TO THE URL SHOWED
EARLIER AND DO A SEARCH FROM THE
DATA ALREADY COLLECT ED E.H.R.
INFORMATION AND THERE'S EVERY
LAP IN THE DIAGNOSES OR TERMS
BUT WANT TO GIVE A FLAVOR OF
WHAT'S IN THE DATA SET.
THERE'S ONE OF OUR LIFESTYLE
SURVEYS WE AND PEOPLE ANSWERED
THE SURVEY AND YOU CAN SEE THE
FIRST QUESTIONS ARE AROUND
TOBACCO USE, ELECTRONIC MODES OF
TOBACCO USE AND IN YOUR LIFE
HAVE YOU HAD AT LEAST ONE DRINK
OF ALCOHOL NOT COUNTING SMALL
TAPES OR SIPS.
315 PEOPLE RESPONDED YET YES TO
THE QUESTION.
YOU CAN SEE THE VARIOUS DRINKING
FREQUENCIES ILLUSTRATED HERE
MONTHLY OR LESS, RANGING TO FOUR
OR MORE PER WEEK AND IF YOU
DRILL DOWN ON A TYPICAL WEEK,
YOU CAN SEE HOW IT BREAKS DOWN
TENS OF THOUSAND OF PEOPLE
HAVING MULTIPLE DRINKS AND SOME
PER DAY AND 1,000 HAVING SEVEN
TO NINE OR TEN OR MORE DRINKS
PER DAY.
SO THIS IS THE KIND OF DATA
WE'VE BEEN COLLECTING.
I CAN'T SAY I'M SURE THERE'S
OPPORTUNITIES TO ENHANCE WAYS
WE'RE COLLECTING DATA FROM
PARTL
PARTLIES.
ANYBODY CAN SEARCH WHAT PROJECTS
ARE HAPPENING AT THE RESEARCHER
WORK BENCH USING THIS URL.
AND WHEN WE USE THE TERM ALCOHOL
USE TO DO OUR SEARCH, WE COME UP
WITH 22 ACTIVE PROJECTS ALREADY
ON THE RESEARCH TO WORK BENCH.
I'M ILLUSTRATING SO YOU SEE THE
FLAVOR OF WHAT THE INFORMATION
LOOKS LIKE.
THERE'S A PROJECT ON MACHINE
LEARNING TO IDENTIFY INDIVIDUALS
WITH AUD AND E.H.R. ANALYSIS FOR
NON-ALCOHOLIC FATTY LIVER
DISEASE AND THERE'S GENETIC
STUDIES LOOKING AT GENETIC UN
UNDERPINNINGS OF ALCOHOL USE
DISORDER.
THESE ARE FEATURES YOU CAN
SEARCH READILY ON YOUR OWN.
I JUST WANED TO HIGHLIGHT WHAT
THINGS LOOK LIKE AS OF A FEW
DAYS AGO.
IN THE LAST FEW MINUTES BEFORE
WE OPEN IT UP FOR DISCUSSION I
WANT TO TALK ABOUT PARTNERSHIP
OPPORTUNITIES.
FIRST I WANT TO HIGHLIGHT THE
FACT CURRENTLY IN COLLABORATION
WITH MULTIPLE INSTITUTES AND
CENTERS ACROSS THE NIH ALL OF US
HAS AN RO3RFA OUT AND AN R21.
THE RO3 IS MEANT TO SUPPORT
ANALYTIC WORK AT THE RESEARCHER
WORK BENCH AND THE R21 IS ON
METHODOLOGIC PROPOSALS AND ALL
OF US IS CALLING FOR
ADMINISTRATIVE SUPPLEMENTS TO
PROMOTE WORKFORCE DIVERSITY
USING OUR DATA SET AND PROBABLY
LESS RELEVANT TO THIS GROUP A
CALL FOR A NEW PARTICIPANT AND
PARTNER SERVICES CENTER A
PLATFORM OUR PARTICIPANTS
INTERACT WITH USING APPS ON
THEIR PHONE OR WEBSITE AND WE'RE
ALSO ABOUT TO RELEASE A NEW CALL
FOR CENTER FOR LINKAGES OF
ACQUISITION OF DATA.
MAINLY DATA LINKAGES ON
ENVIRONMENTAL DATA AND OTHER
UBIQUITOUS DATA.
LAST YEAR WE AWARDED
ADMINISTRATIVE SUPPLEMENTS USING
OUR DATA.
WE HAD 33 APPLICANTS, 25 WERE
AWARDED AND YOU CAN SEE SOME
SELECTED FOR FUNDING AND SOME
SELECTED IN SUPPORT WITH OUR
FUNDS AND OTHER RICs OR OTHER
OFFICES.
CALLING YOUR ATTENTION TO ONE OF
THE NOSIS CO-SPONSORED WITH
NIAAA AROUND VALIDATION STUDY OF
GENETIC VARIANTS AND PD10
DETERMINED AT THE U.K. BIO BANK
DATA SET AND LOOKING AT HOW
THESE VALIDATE OR DON'T VALIDATE
IN THE DIVERSITY OF THE
POPULATION ON THE ALL OF US
RESEARCH DATA PLATFORM.
THE GOAL IS TO ENROLL 100
PARTICIPANTS AND EXPAND THE DATA
AVAILABLE AND LAUNCH ANCILLARY
STUDIES AND HAVE 10,000
RESEARCHERS AT OUR RESEARCHER
WORK BENCH AND THEN IMPORTANTLY
TO RETURN VALUE TO OUR
PARTICIPANTS.
THE AREA WHERE PARTNERSHIPS
RESIDE ARE ANCILLARY STUDIES.
THIS WILL EXPAND OUR DATA SET BY
ADDING NEW DATA TYPES EITHER
HAVE BIO SPECIMENS OR
INFORMATION DIRECTLY GATHERED
FROM PARTICIPANTS IN THE FORM OF
SURVEYS OR EVEN IN RECRUITING
PARTICIPANTS OR ASKING THEM TO
COME BACK FOR MORE DETAILED
ANALYSIS OR FIT INTO THE STUDIES
OR OTHER TYPES OF TRIALS WE
MIGHT WANT TO HAVE THEM
PARTICIPATE IN.
THERE'S A FAIRLY DIVERSE SET OF
OPPORTUNITIES FOR ANCILLARY
STUDIES TO AUGMENT THE GROWING
DATA PLATFORM.
THIS IS ANOTHER VIEW OF
ANCILLARY STUDIES.
THE TRIANGLE OR PYRAMID SHOWS
FIRST AT THE BOTTOM THE DATA
WE'RE COLLECTING AT PART OF THE
CORE PROTOCOL FOR ALL OF US.
WE'VE HAD THREEAN ANANCE -- TH
ANCILLARY STUDIES ONE LOOKING AT
SARS COV2 ANTIBODIES ACROSS OUR
POPULATION.
THIS IS A BIO SPECIMEN STUDY
THAT JUST GENERATES NEW DATA.
WE LAUNCHED IN DECEMBER WITH ONE
OF THE OTHER NIH INSTITUTES A
PROJECT CALLED EXPLORING THE
MIND BRINGING INDIVIDUALS FOR
COGNITIVE TESTING USING
WEARABLES AND SURVEYS AND IN A
MONTH OR SO WE'LL ENROLL OUR
FIRST PARTICIPANTS IN A LARGE
STUDY CALLED NUTRITION FOR
PRECISION HEALTH WHERE 10,000
INDIVIDUALS WILL BE RECONTACTED
AND GIVEN DETAILED DIETARY
INFORMATION AND HAVE A FEEDING
STUDY AND A NUMBER OF OTHER
CHALLENGES TO GIVE OPPORTUNITY
TO DO INDIVIDUALIZED DIETARY
ASSESSMENT.
THE POINT ALSO ON THE RIGHT-HAND
SIDE IS WE HAVE A RANGE OF
COMPLEXITY OF THESE STUDIES, BIO
SPECIMEN OR THE LOWER COMPLEXITY
STUDIES BUT THE TOP WE'RE OPEN
TO DOING RANDOMIZED CONTROL
CLINICAL TRIALS USING THE
PLATFORM AND OUR PARTICIPANTS AS
A BASIS FOR ENROLLMENT AND
RECRUITMENT.
WE EXPECT OUR ANCILLARY STUDIES
TO BE SOME WE WANT TO GO AFTER
BECAUSE THEY ALIGN WITH OUR
SCIENTIFIC ROAD MAP BUT WE'RE
ALSO EXPECTING A NUMBER OF ICOs
AND INSTITUTE AND CENTERS WITH
REQUEST TO PARTNERSHIP AND THE
FOCUS AROUND NIH IS HOW THE
FIRST TWO AREAS FOR ANCILLARY
STUDIES BUT WANT TO MAKE SURE
THEY'RE FEASIBLE.
WE'LL PROBABLY PILOT MOST IN
SMALL SCALE AND THEN SCALE UP.
WE ALSO INSIST THEY CONTINUE TO
ACCRUE VALUE TO OUR PARTICIPANTS
AND ALSO AS I MENTIONED ALREADY
ENHANCE OUR OVER ALL DATA
RESOURCE.
SO ON THE LAST SLIDE I GUESS IS
THE MONEY SLIDE FOR THIS
PARTICULAR DISCUSSION IS HOW CAN
WE WORK MORE CLOSELY -- HOW CAN
ALL OF US AT NIAAA WORK MORE
CLOSELY.
AS I MENTIONED, WE ALREADY HAVE
SUBSTANCE USE AND ALCOHOL
SPECIFIC QUESTIONS IN OUR
SURVEYS.
THIS IS ON OUR SCIENTIFIC ROAD
MAP AND BELIEVE THE AREAS OF
SUBSTANCE USE AND ALCOHOLISM
WILL ACTUALLY HAVE AN IMPACT
ACROSS MANY FOCUS AREAS I'VE
SHOWED IN THE BRIEF ILLUSTRATION
OF OUR SCIENTIFIC AGENDA.
WE THINK THE DIVERSITY OF OUR
PARTICIPANTS IS A UNIQUE
OPPORTUNITY MOST LONGITUDINAL
POPULATIONS STUDIES CANNOT
AFFORD WITH THE TYPES OF DATA
WE'RE COLLECTING AND I WANT TO
EMPHASIZE I INFERRED THE SOCIAL
DETERMINATES OF HEALTH AND
ENVIRONMENTAL DATA MIGHT BE VERY
SYNERGISTIC WITH THE OTHER
FEATURES AND IMPORTANCE OF
SUBSTANCE USE OR ABUSE.
I MENTIONED THE FACT WE HAVE
MULTI-DIMENSIONAL DATA.
HOPEFULLY THERE ARE ALREADY
EXISTING RESEARCH PROGRAMS AND
STRATEGIES AT NIAAA WE CAN
FACILITATE THE RAPID DEPLOYMENT
WITH OUR DATA AND TEST
HYPOTHESES IN WAYS THAT ARE
MAYBE NOT ABLE TO TODAY.
AT THE BOTTOM I KNOW YOU ASKED
THE QUESTION AND I ATTENDED
ABOUT THE PHARMACO EPIDEMIOLOGIC
ACTIVITIES AND YOUR TEAM WAS
INTERESTED IN MODULATING
BEHAVIORS AND WE HAVE E.H.R.
DATA AND WHEN I LOOKED WE HAD
ABOUT 10,000 USERS OF
SPIRONOLACTONE AND I SHOWED YOU
INDIVIDUALS WHO ARE USING
ALCOHOL.
WE ALSO HAVE THE TEMPORALITY OF
THE DATA AND WHEN THEY STARTED
USING THE MEDICATION.
THE BASIS IS THERE FOR EXPANSION
OF THE WORK YOU'VE BEEN DOING IN
THE AREA OF PHARMACO
EPIDEMIOLOGY OR LOOKING AT POINT
OF CARELY OTHER AGENTS AS
YOYOUR
TEAM SEES FIT AND I'LL SAY THANK
YOU AND OPEN THE FLOOR FOR
QUESTION OR COMMENTS.
>>WE WERE LOOKING INTO GETTING
THE AUDIT C PART OF THE TOOLBOX
FOR THE RECORD.
AND WIDELY USED AT NIH THAT'S
WHERE YOU SEE THE BREAKDOWN OF
SOME THINGS GEOFF ARE ARE MAKE
GEO
GEOFFREY IS MAKING.
YOU MIGHT EVEN CONSIDER
TELLING -- OR SUGGESTING TO THE
POWERS -- I DON'T TELL THEM
ANYTHING, THAT PERHAPS YOU CAN
RECORD THE SAME TALK FOR THEM.
ANYWAY, COUNCIL MEMBERS, ANY
QUESTIONS OR THOUGHTS OR
COMMENTS?
I THINK YOU CAN SEE THE
OPPORTUNITIES HERE ARE
PRONOUNCED IN MY VIEW.
THIS IS NOT A COHORT THAT'S
SCREENED FOR ANYTHING IN
PARTICULAR.
THESE ARE FREE-RANGING HUMANS.
I PERSONALLY THINK THERE'S VALUE
TO THAT.
>>THIS IS AN IMPRESSIVE PROJECT
AND YOU CAN SEE THE GOAL THAT
CAN COME FROM IT.
I QUICKLY COVERED A COUPLE
THINGS AND WONDER IF YOU CAN
ELABORATE ON WHAT IMAGING AND
COGNITIVE DATA THE SAMPLE HAS.
>>I SAID ON IMAGING WE'RE JUST
GOING AFTER IMAGING.
E.H.R.s ARE KNNOTORIOUS FOR NOT
HAVING PRIMARY IMAGING DATA.
WE'RE TALKING TO SEVERAL OTHER
NIH INSTITUTES THAT HAVE
INTEREST IN THINGS LIKE RETINAL
SCANS AND OTHER TYPES OF MRI
DATA WE HOPE TO BE ABLE TO
IMPORT THOSE AND LOOKING AT
NATURAL LANGUAGE TO CAPTURE THE
REPORT AND WE'RE LOOKING AT THE
DATA AND THE OTHER QUESTION?
>>COGNITIVE TESTING.
>>THE EXPLORING THE MIND
PROGRAM I MENTIONED HAS FIVE
COGNITIVE TESTS THE NAMES OF
WHICH I'M BLANKING ON BUT CAN
CERTAINLY SHARE THEM WITH YOU
AND ALSO IF YOU GO TO THE "ALL
OF US" WEBSITE I THINK IT WILL
HAVE THE EXPLORING THE MIND
PROTOCOL OR AT LEAST SUMMARY OF
THE PROTOCOL AVAILABLE.
THE FIRSTANCE ANCE -- FIRST
ANCILLARY STUDY WILL HAVE AN
ANALYSIS AND ASSUMING IT'S
POSITIVE WE HOPE TO SCALE ALL
FIVE OF THOSE COGNITIVE TESTS TO
THE ENTIRE COHORT.
THOSE PARTICIPANTS THAT WOULD
LIKE TO PARTICIPANT IN THAT.
WE CAN DO MORE.
THAT WAS JUST REALLY BROUGHT TO
US BY NIMH AND WE'RE OPEN TO
EXPANDING THAT REPERTOIRE OF
TESTING AS YOU MIGHT SEE FIT.
>>THANK YOU.
>>KATIE.
>>THANK YOU SO MUCH.
THIS WAS REALLY GREAT.
I'M SO EXCITED TO SEE THE RFAs
FOR ANALYSIS OF THIS BECAUSE
IT'S REALLY A WONDERFUL
RESOURCE.
I ALSO WANTED TO SHARE THAT I
SAW THE ALL OF US VAN ON MY
CAMPUS.
SO WE'RE RECRUITING FROM THE
UNIVERSITY WHICH IS GREAT.
WE HAVE A WONDERFUL AND DIVERSE
STUDENT BODY AND FACULTY AND
STAFF.
I WAS EXCITED TO SEE THE ALL OF
US VAN.
I WANTED TO SHARE THIS AROUND
LANGUAGE AND NIAAA IS MOVING
TOWARDS ALCOHOL USE DISORDER AND
OTHER TERMS THAT ARE
STIGMATIZING AND IF THEY SHOW UP
IN YOUR DASHBOARD AND I DON'T
KNOW HOW TO GET THEM CHANGED.
JUST WANTED TO SHARE THAT TO GET
ON BOARD WITH THE LANGUAGE
EXCHANGES AS WELL.
>>THANK YOU, AND I'LL SHARE
THIS WITH MY COLLEAGUES.
THE DATA I SHOWED YOU WAS
EXTRACTED FROM ICD10 CODING.
I DON'T KNOW HOW MUCH YOU HAVE
AN INFLUENCE ON THAT PART OF OUR
MEDICAL COMPLEX THAT WAS NOT OUR
CHOICE BUT WHAT IS IN THE DATA
SET.
IT'S A LONGER DISCUSSION WE
DON'T HAVE TIME FOR BUT I DON'T
KNOW HOW YOU CHANGE THAT PART.
>>AND ICD11 IS RELATED TO
ALCOHOL DEPENDENCE AND THANK YOU
FOR THAT AND THANK YOU.
IT WAS GREAT.
>>THERE ARE MORE WOMEN THAN MEN
CURRENTLY IN OUR COHORT.
WE'RE NOT GOING TO BE
NECESSARILY REPRESENTATIVE OF
THE U.S. AND I CAN'T FIND THE
DATA RIGHT NOW.
>>IT'S NOT WHAT IT'S
REPRESENTATIVE BUT ARE THE DATA
IDENTIFIED BY SEX AND PERHAPS
GENDER?
DO THE PEOPLE INDICATE WHETHER
THEY ARE WHICH GENDER THEY
PREFER TO BE RECOGNIZED BY?
>>SO THERE'S A COUPLE OF PIECES
OF THAT.
IF YOU GO TO -- WHEN YOU GO TO
THE RESEARCH OR BROWSER, WHEN --
LET ME SEE IF I CAN SHARE MY
SCREEN AGAIN.
THERE'S CODES USED AND THERE'S
SEX AND GENDER NOT ON THE
PUBLICLY FACING TIERS BUT
ANYBODY CAN GET TO HIGHER ISSUES
AROUND PRIVACY AND
CONFIDENTIALITY WHEN IT COMES TO
THE DATA SET BUT YOU NEED TO
PASS MODULES LIKE A CITY MODULES
TO GET TO GREATER ACCESS.
I JUST WANTED TO SHOW YOU CAN
SEE RIGHT NOW THE SEX BREAK DOWN
ON THE FEE IN OUR DATA SET.
>>PERFECT, THANK YOU.
>>SO IN THE INTEREST OF TIME WE
PROBABLY SHOULD MOVE ON.
>>NOT SURE YOU SAW THE HAND UP.
>>MY VIDEO SAYS IT'S TURNED OFF
BY HOST BUT I'M HERE.
THANK YOU, DR. GINSBURG FOR A
PHENOMENAL PRESENTATION.
I'D LIKE TO GO BACK TO A VERY
EARLY SLIDE WITH YOUR TRIANGLE
AND ONE OF THE LAST GROUPS YOU
ADDED IN TOWARDS THE TOP WERE
THE IMPACT OF HEALTH SYSTEMS AND
PAYERS.
AND I'M WONDERING IF YOU CAN
EXPAND ON THAT A LITTLE BIT MORE
AND WHAT THAT MEANS IN TERMS OF
FITTING INTO THE ROAD MAP.
I ALSO WOULD LIKE TO KNOW IF
THERE ARE ANY PLANS TO HAVE
OUTSIDE DATABASES THAT CAN WITH
INFORMATION THAT DOES AFFECT
ACCESS TO CARE AND THINGS LIKE
THAT RELATED TO FINANCING AND
ORGANIZATIONAL ISSUES.
>>SO I THINK YOU'RE REFERRING
TO THE SLIDE OF THE ROAD MAP
SLIDE.
>>YES.
WE ARE PUTTING TOGETHER A
TRANSLATIONAL WORK STREAM AND
WORKING GROUP THAT WILL HELP US
DO THE OUTREACH TO THE KINDS OF
ORGANIZATIONS THAT ARE GOING TO
BE NECESSARY TO PARTNER WITH TO
TRANSLATE OUR RESEARCH BROADLY
SPEAKING.
ALL OF US IS A RESEARCH PROGRAM.
WE ARE NOT A HEALTH SYSTEM.
WE'RE NOT A HEALTH CARE
PROVIDER.
IF WE'RE GOING TO SEE ANY OF THE
FINDINGS THAT COME OUT FROM OUR
PERSPECTIVE, WE'RE SEE
INDIVIDUAL AND POPULATION HEALTH
IMPACT WE HAVE TO DEVELOP A
SERIES OF PARTNERSHIPS TO ENABLE
THAT TO HAPPEN OR FACILITATE
THEM AND THE NIH HAS MECHANISMS
LIKE SBIRs BUT WE'LL HAVE TO BE
MORE STRATEGIC AND I WOULD SAY
AGGRESSIVE TO MAKE THAT HAPPEN
BECAUSE OUR GOAL ARE TO
FACILITATE AND ENABLE THE
TRANSLATION OF OUR FINDINGS.
AM I ADDRESSING YOUR QUESTION?
>>YOU ARE BUT I'M ALSO
REFERRING TO THE KINDS OF DATA
THAT MAY BE IN ELECTRONIC HEALTH
RECORDS THAT ARE MORE ALONG THE
LINES OF SERVICES RESEARCH AND
HOW IT'S STRUCTURED.
YES, I DID HAVE A QUESTION THE
TRANSLATION PART BUT THE OTHER
TYPES OF VARIABLES LIKE THAT.
>>I DIDN'T GO THROUGH THE
SURVEYS WE ADMINISTERED THAT I
THINK MIGHT BE RELEVANT TO YOUR
QUESTION.
I DID MENTION WE HAVE AN
EXTENSIVE SOCIAL DETERMINATES OF
HEALTH DATA THAT WAS RELEASED
LAST YEAR.
WE ALSO HAVE HEALTH CARE ACCESS
AND WE HAVE A LARGE AMOUNT OF
DATA ON ACCESSIBILITY TO HEALTH
CARE.
IF I'M UNDERSTANDING YOUR
QUESTION, OUR DATA IN THE ONLY
IS AN OPPORTUNITY FOR RESEARCH
BUT LAYS THE GROUND WORK FOR US
TO UNDERSTAND WHERE AND IF WE'RE
GOING TO TRANSLATE TO DIFFERENT
HEALTH CARE ENVIRONMENTS WHAT
MIGHT BE SOME OF THE CHALLENGES
WE NEED TO ADDRESS UP FRONT IN
ORDER TO MAKE THAT HAPPEN.
TWO THINGS.
ONE I'D LOVE TO HEAR MAYBE
OFFLINE OR OTHER WAYS YOU THINK
WE SHOULD BE THINKING ABOUT THIS
OR I'M HAPPY TO COME BACK AND
GIVE THE GROUP MORE INFORMATION
WHEN WE HAVE MORE TRANSLATIONAL
STRATEGIES IN PLACE.
>>GREAT.
THANK YOU.
>>THANK YOU SO MUCH.
I THINK WE PROBABLY NEED TO MOVE
ON BUT I WANT TO EMPHASIZE AGAIN
IF YOU HAVE FURTHER QUESTIONS
AND YOU WANT -- I'M SURE YOU CAN
CONTACT GEOFFREY DIRECTLY BUT IF
YOU WANT TO FEED THEM THROUGH
OUR INTERACTION YOU CAN GO
THROUGH ME OR THROUGH LAURA.
DAVID, DID YOU HAVE ONE QUICK
COMMENT.
>>EXACTLY THAT.
I WENT TO DR. GINSBURG'S WEBSITE
TO GET HIS E-MAIL AND IT'S NOT
THERE.
IF YOU'RE COMFORTABLE SHARING
YOUR E-MAIL I'D LOVE TO ASK YOU
A COMPLICATED QUESTION.
>>IT'S IN THE CHAT.
>>THANK YOU.
>>A PLEASURE.
>>THANK YOU SO MUCH.
IT WAS GREAT.
>>LET ME KNOW ABOUT OTHER
MEETINGS OUTSIDE THE NIH.
>>WILL DO.
OKAY.
NEXT ON OUR AGENDA ONE OF OUR
COUNCIL MEMBERS WILL PRESENT.
I'D LIKE TO INTRODUCE DR. NANCY
BARNETT A PROFESSOR OF
BEHAVIORAL AND SOCIAL SCIENCES
AND PROFESSOR OF PSYCHIATRY AND
HUMAN BEHAVIOR AT BROWN
UNIVERSITY.
SHE'S ALSO ASSOCIATE DEAN FOR
FACULTY AFFAIRS AT THE SCHOOL OF
PUBLIC HEALTH RESPONSIBLE FOR
OVERSEEING FACULTY SEARCHES,
HIRES AND APPOINTMENTS AND
SUPPORT CAREER DEVELOPMENT OF
THE FACULTY IN THE DEPARTMENT OF
SCHOOL PUBLIC HEALTH.
HER RESEARCH IS CONDUCTED AT THE
CENTER FOR ALCOHOL AND ADDICTION
STUDIES.
SHE COMPLETED HER GRADUATE
TRAINING AT THE UNIVERSITY OF
WASHINGTON AND POST-DOCTORAL
TRAINING AT BROWN UNIVERSITY.
HER PRIMARY AREAS OF INTEREST
ARE DEVELOPING AND TESTING BRIEF
INVENTIONS FOR YOUNG ADOLESCENTS
AND YOUNG ADULTS.
THE INFLUENCE OF ASSOCIATE
NETWORKS ON ALCOHOL USE AND
WEARABLE TECHNOLOGY FOR
ASSESSMENT AND TREATMENT OF
ALCOHOL USE AND RELATED
PROBLEMS.
HER RESEARCH HAS BEEN FUNDED BY
NIAAA FOR SOME TIME.
HER RECENT PUBLICATIONS HAVE
FOCUSSED ON PEER-INFLUENCES
WITHIN SOCIAL NETWORKS, BEHAVIOR
CHANGE FOLLOWING ALCOHOL-RELATED
EXPERIENCES, THE EFFICACY OF
CONTINGENCY MANAGEMENT FOR
REDUCING ALCOHOL USE AND THE
UTILITY OF ALCOHOL BIO SENSORS
FOR RESEARCH AND CLINICAL
APPLICATION.
DR. B BARNETT SERVED ON
COMMITTEES OR THE CENTER FOR
REVIEW AND NIAAA AND ON THE
RESEARCH SOCIETY ON ALCOHOLISM.
NANCY IS A PERSON I TURN TO WHEN
I HAVE QUESTIONS IN THESE
DOMAINS.
SHE'S DONE PRE PRODIGIOUS
AMOUNTS OF WORK AND WILL TALK
ABOUT BIO SENSORS AND STATE OF
THE SCIENCE AND OPPORTUNITIES
AND FUTURE DIRECTION.
IT'S ALL YOURS.
>>CAN YOU HEAR ME OKAY?
>>YOU'RE GOOD.
>>I WANT TO START BY THANKING
DIRECTOR KOOB FOR INVITING ME.
I'LL TALK ABOUT ALCOHOL BIO
SENSORS THAT TRACK ALCOHOL USE
A
AND INTERESTING IN LOOKING AT
THE STATE OF THE SCIENCE AND
TALKING FIRST ABOUT THE GOALS
FOR PASSIVE SENSING.
WHAT WE DO -- WHAT DO WE AS
RESEARCHERS AND CLINICIANS WANT
THESE DEVICES TO DO FOR US.
AND THE PEOPLE WE WORK WITH AND
RELATEDLY, WHAT FEATURES OF
THESE DEVICES THAT ARE CURRENTLY
AVAILABLE FOR USE WHAT ARE THEIR
LIMITATIONS AND WHAT WE'LL DID
AND I'LL TALK HOW RESEARCHERS
ARE ATTEMPTING TO ADDRESS THE
LIMITATIONS AND THE DEVICES I'M
AWARE OF COMING DOWN THE
PIPELINE THAT WE CAN BE LOOKING
FORWARD TO WORKING WITH.
SO SHE'S THE GOALS I'VE LAID OUT
FOR TODAY AND THEY'RE CONSISTENT
WITH WHAT NIAAA HAS STATED THAT
NIAAA WOULD EXPECT BIO SENSORS
WOULD DO IN THEIR CALLS FOR MORE
WORK IN THIS AREA.
IT HAS TO BE EXACTABLE TO THE
WEARER OR YOU GET POOR
COMPLIANCE.
THE FORM FACTOR HAS TO BE
MINIMALLY INVASIVE AND
ACCEPTABLE AND AFFORDABLE AND
VALID.
AND COMPARED TO A GOLD STANDARD
AND WE'RE INTERESTED TO KNOW
WHETHER IT CAN DETECT HEAVY
DRINKING.
WE NEED TO KNOW WHAT THE BAC IS
OR PEAK REACH AND TOTAL ALCOHOL
AKIN TO A NUMBER OF DRINKS
CONSUMED.
AND GETTING INFORMATION AND THIS
IS SOMETHING I'M KIND OF EXCITED
ABOUT SEEING DEVELOPED, GETTING
INFORMATION ABOUT THE ALCOHOL
EPISODE ITSELF.
THIS IS A STRENGTH OF SENSORS OR
OTHER MONITORS THAT GET
CONTINUOUS DATA, THIS TIME
SERIOUS GIVES US RICH
INFORMATION AND THE EPISODE
CHARACTERISTICS SHOULD TELL US
SOMETHING ABOUT RISK ABOVE PEAK
LEVEL OF ALCOHOL CONCENTRATION
RELIABILITY IS KEY AND THEY HAVE
TO COMPARE WELL, BE STABLE WITH
FEW FAILURES LEADING TO LOST
DATA AND FINALLY AND THIS IS A
KEY POINT AND THE MOST EXCITING
PART, WE HAVE TO BE ABLE TO
QUICKLY GET ACCESS TO THE DATA
FOR WIRELESS TRANSMISSION TO
SERVERS AND BEING ABLE TO ACCESS
THE DATA AND ESPECIALLY
IMPORTANT FOR WIDESPREAD
ADOPTION WE NEED TOOLS TO HELP
PEOPLE INTERPRET AND USE THE
DATA.
SO THIS IS A TABLE FROM A RECENT
PAPER THAT REVIEWS AVAILABLE
DEVICES AND IT HELPS SHOW WHY
I'M GOING TO PRIMARILY TALK
ABOUT TWO DEVICES TODAY, THE
SCRAM AND THE SKIN.
RIGHT OFF BOTH DEVICES MEASURE
THE SMALL AMOUNT OF ALCOHOL
SECRETED THROUGH THE SKIN.
IT THEN PROVIDES TRANS DERMAL
ALCOHOL CONCENTRATION.
THEY'RE BOTH COMMERCIALLY
AVAILABLE WHEREAS TWO OTHER
TRANS JOURNAL SENSES ARE NOT
CURRENTLY AVAILABLE AND THERE
ARE A FEW AND THERE'S SOME
COMMERCI
TESTED BUT NOT COMMERCIALLY
AVAILABLE YET AND I'M GOING TO
TALK ABOUT WHAT SOMEONE CAN PICK
UP IN THEIR LAB AND USE FOR
RESEARCH AND UNDERSTAND THERE'S
MORE COMING DOWN THE ROAD.
FOR THOSE WHO HAVEN'T SEEN THE
DEVICES THIS IS WHAT THEY LOOK
LIKE, THE SCRAM IS CONTINUOUS
MONITORING AND THE SCRAM IS ONE
ON THE ANKLE.
IT CAN'T BE REMOVED WITHOUT
CUTTING THE STRAP OR REMOVING
THE PLASTIC STRIP.
THESE ARE FOR PEOPLE COURT
ORDERED TO WEAR THEM AND A FORM
OF PROBATION.
THEY'RE LOCKED ON.
THEY'RE ALSO USED FOR RESEARCH
PURPOSES.
WE'VE HAD GOOD SUCCESS BUT THEY
ARE LIMITED.
LIMITED BY ITS APPEARANCE.
THE SKYN IS REMOVABLE.
THE SCRAM CAN'T BE SUBMERGED BUT
YOU CAN SHOWER WITH IT BUT THEY
SYNC USING DIFFERENT METHODS AND
THE DATA IS TRANSMITTED AND THE
SKNY REQUIRES THE PARTICIPANT TO
OPEN THE APP ON THEIR PHONE AND
NEITHER ARE GREAT BECAUSE EVERY
30 MINUTES OF INFORMATION IS NOT
GRANULAR ENOUGH AND 20 SECONDS
IS KIND OF TOO OFTEN.
I'LL SHOW YOU WHAT I MEAN BY
THAT.
FOR THOSE WHO HAVE GRADE
SCHOOLERS WE GIVE THEM A CHECK
MINUS OR CHECK PLUS FOR
ACCEPTABILITY.
THAT'S PRIMARILY FOR THE FORM
FACTOR.
HERE'S OUR NEXT SET OF GOALS OF
VALIDITY.
I WANTED TO SHOW BY SHOWING WHAT
THE RAW DATA LOOKS LIKE FROM THE
DEVICES.
THEY BOTH GIVE YOU TAC LEVEL.
THE SCRAM HAS A METRIC WE'RE
FAMILIAR WITH THE BAC METRIC.
THE SKYN HAS TIME STAMPS TO
ALLOW TO MEASURE THE TIME AND WE
HAVE OTHER INFORMATION WE'RE NOT
QUITE TO THE POINT WHERE WE'RE
EFFECTIVELY USING THE OTHER
SENSORS BUT THERE'S POTENTIAL
THERE.
HERE'S WHAT THE SCRAM DATA LOOK
LIKE.
NOT ALL CURVES LOOK LIKE THIS
BUT YOU GET FAIRLY CLEAN DATA
AND THE TEMPERATURE'S IN RED AND
THE ORANGE BARS TELL YOU WHEN
THE PERSON WAS CONSIDERED BY THE
SCRAM COMPANY TO MEET THEIR
CRITERIA FOR DRINKING.
THESE CRITERIA AND I'LL TALK
ABOUT THESE, THEY'RE A SET OF
CRITERIA AND THEY GENERALLY HAVE
TO DO WITH THE MINIMUM LEVEL THE
TAC HAS HIT BEFORE YOU CONSIDER
A POSSIBLE EPISODE AND THE SLOPE
AND THE PEAK AND THE AREA UNDER
THE CURVE YOU CAN MEASURE THE
ENTIRE AREA UNDER THE CURVE AND
LENGTH OF THE EPISODE.
THERE'S LOTS OF METRICS WE CAN
PULL FROM THE INFORMATION.
SOME OF MY WORK HAS SHOWN THE
CRITERIA FROM THE SCRAM COMPANY
TO BE TOO STRINGENT FOR OUR
PURPOSES FOR RESEARCH PURPOSES
OR CLINICAL PURPOSES.
THAT'S UNDERSTANDABLE BECAUSE
THE COMPANY'S BREAD AND BUTTER
IS PEOPLE WHO ARE MANDATED TO
WEAR THIS DEVICE AND IF THEY'RE
CAUGHT DRINKING THEY GO TO JAIL.
SO FALSE POSITIVES HAVE TO NOT
HAPPEN.
FOR US THERE'S MORE COMFORT AND
MORE TOLERANCE FOR THE LOWER --
I CAN ACCEPT SOME FALSE
POSITIVES TO GET BETTER
SPECIFICITY AND WE ADJUST THE
CRITERIA AND THEY FAIR WELL AND
HAVE BEEN BY MYSELF AND THE SKYN
DATA NOT SO PRETTY.
THE VISUAL REFLECTS WHAT WE
COMMONLY SEE INCLUDING THE SHARP
PEAKS.
IT'S UP TO 500.
YOU SEE A LOT OF JITTER AND
VALUES BELOW ZERO.
SO WE HAVE TO DEVELOP WAYS TO
DEAL WITH THESE ISSUES INCLUDING
SMOOTHING, RECODING DATA POINTS.
I'M NOT SO SURE RECODING VALUES
BELOW ZERO IS THE RIGHT WAY TO
GO.
RECODING LOW VALUES TO ZERO IS
THE WAY TO GO BUT TIME WILL
TELL.
THIS IS A GOOD INDICATION OF WHY
YOU CAN'T JUST PULL THE DATA,
MAKE DECISIONS ABOUT IT AND USE
IT IMMEDIATELY TO TELL YOU
WHETHER THERE'S ALCOHOL CONSUMED
OR NOT.
WHEN WE TALK ABOUT VAL TI WE
HAVE INCREASING EVIDENCE THE
ABILITY OF SENSORS TO DETECT
ALCOHOL USE IS QUITE GOOD AND WE
CHARACTERIZED EVERY SELF-REPORT
DRINKING EPISODE ADJUSTING THE
CRITERIA I REFERRED TO AND IT
INCLUDED RISE, PEAK AND FALL AND
WE GRAPH THESE A LOT WITH DRINKS
ALONG THE X AXIS AND THE PERCENT
OF SELF-REPORTED DRINKING
EPISODES DETECTED BY TC ON THE Y
AXIS.
YOU'LL NOTICE AN INFLECTION
POINT HERE.
AT TWO TO THREE DRINKS DETECTION
AIS QUITE GOOD AND THE TO FOUR
IS GOOD FOR WOMEN AND BEYOND
FIVE IT'S VERY GOOD FOR MEN AND
WOMEN.
HERE'S THE AREA WE'RE KIND OF
CONCERNED ABOUT.
WE CAN'T CONFIDENTLY SAY WE CAN
DETECT THIS BETWEEN THE DISTANCE
FROM 0 AND .02 IS SMALL IN
ENVIRONMENTAL EXPOSURE.
IT'S MUCH HARDER TO DO THAN YOU
MIGHT THINK.
THERE HAS BEEN SOME EFFORT TO DO
BETTER THAN THIS USING
ADJUSTMENTS AND RULES.
I THINK IT'S GOING TO CONTINUE
TO BE CHALLENGING SIMILAR TO A
BREATHALYZER TO DETECT ONE DRINK
MAYBE TWO.
WITH FIELD DATA WHEN YOU DON'T
KNOW WHERE TO LOOK FOR THE DATA
IT'S HARD TO IDENTIFY ONE DRINK.
THERE'S A LABORATORY-BASED STUDY
THAT THIS INCLUDES BRAC IN THE
BLACK AND SCRAM AND SKYN AND HAD
ALL PARADIGMS.
THESE ARE FIVE INDIVIDUAL DATA.
IF YOU LOOK AT THE BRAC IN BLACK
QUITE STABLE.
IT LOOKS GOOD AND THERE'S A LOT
OF VARIABILITY IN THE SCRAM WHEN
IT SHOULD LOOK LIKE BRAC AND
WITH SKYN FROM PERSON FIVE TO 25
THE RED LINES START GETTING
WONKY NEAR THE END.
BECAUSE THERE'S VARIABILITY
BETWEEN PEOPLE, THERE'S GOING TO
BE VARIABILITY WHEN YOU COMPARE
DEVICES WITHIN PERSON AND THAT'S
THE SORT OF THING WE HAVE TO
GRAPPLE WITH.
NOW, BOTH OF THESE DEVICES YOU
CAN SEE HERE, BOTH OF THESE
DEVICES SHOW A DELAY RELATIVE TO
TAC.
THIS IS THE CHARACTERISTIC OF
TRANS DERMAL USE AND IT CAN BE
30 MINUTES OR THREE OR FOUR
HOURS.
SO THAT'S A FEATURE YOU CAN'T
JUST APPLY TRANSFORMATION TO OR
USE A CONSTANT OR ALGORITHM.
IT'S VARIED SO IT'S NOT EASY TO
ADJUST TO SAY CONFIDENTLY WHEN
THE DRINKING BEGAN.
THIS IS GOOD VISUAL HOW
CHALLENGING IT IS TO TRANSLATE
THE TAC AND THE BRAC.
THE HOLY GRAIL.
WHAT WE'LL TRY TO KEEP GOING.
-- KEEP DOING.
THERE'S BEEN A NUMBER OF LAB
STUDIES THAT SHOW THE
CORRELATION BETWEEN PEAK TAC AND
BRAC AND THE CORRELATION OF
TOTAL AREA OF THE CURVE AND
TENDS TO BE GOOD TO VERY GOOD
AND IN FIELD STUDIES THE AREA
UNDER THE CURVE CORRELATES WITH
SELF-REPORTED DRINK.
YOU GET THE SENSE OF THE
QUANTITATIVE VALUE THAT IS
ASSOCIATED WITH HOW MUCH
SOMEBODY HAS CONSUMED FROM THE
CURVES.
NOW, THIS IS A RECENTLY
PUBLISHED PAPER.
I'M EXCITED ABOUT THIS BECAUSE
IT SHOWED THAT WE CAN USE THESE
CHARACTERISTICS OF THE TIME
SERIES TO GIVE US INFORMATION
ABOUT THE RISK A PERSON SHOWED.
BEYOND ALCOHOL USE INTOXICATION
AND VOLUME, THE CHARACTERISTICS
OF THE CURVE AND PRIMARILY I'M
LOOKING HERE THE FASTER TAC RISE
AND FALL ARE ASSOCIATED WITH DAY
LEVEL.
THESE ARE SINGLE EPISODE DAY
LEVEL CONSEQUENCES TOTAL NUMBER
AND INDIVIDUAL SPECIFIC
CONSEQUENCES LIKE BLACKOUT.
THIS IS THE VALUE RIGHT.
THERE'S A LEVEL OF UTILITY WE
GET WE DON'T GET FROM OCCASIONAL
BREATH OR SELF-REPORT
OBSERVATIONS.
AND WE NEED MORE WORK IN THE
DATA TO HELP PREDICT WHAT THE
MORE PROBLEMATIC PATTERNS ARE
FROM THE SENSOR.
WE HAVE GOOD ABILITY TO PREDICT
HEAVY DRINKING AND THERE'S SO
MUCH VARIABILITY WE CAN'T VERIFY
THE TIME CONSUMED AND PEAK
THOUGH SPOILER ALERT THERE'S
GREAT WORK IN THIS AREA.
FOR TOTAL EXPOSURE WE'RE USING C
TO CORRELATE WITH NUMBER OF
DRINKS.
THERE'S NO CONVERSION YOU CAN'T
SAY IT TRANSLATES TO THIS NUMBER
OF DRINKS BUT THERE'S A
QUANTITATE VALUE TO COMPARE IN A
PERSON, CHANGE OVER TIME AND
BETWEEN PEOPLE ROUGHLY OR IN
COMPARISON.
THEN I TALKED ABOUT THE ALCOHOL
EPISODES.
I SHOW RELIABILITY ISSUES.
REMEMBER THE SLIDE FOR FIVE
CASES IT'S DIFFICULT TO KNOW
WHETHER THE VARIABILITY YOU SEE
IS BETWEEN DEVICES.
YOU PUT A DIFFERENT DEVICE ON
PERSON A TO PERSON B OR WHETHER
IT'S INDIVIDUALS.
I THINK IT'S LIKELY BOTH.
WE SEE GOOD IMPROVEMENT IN THE
STABILITY OF DEVICES OVER TIME.
LESS FAILURE WITH RECENT VERGES.
WHAT YOU SEE WITH TAC AS IT GETS
BETTER STABILITY AND RELIABILITY
GETS BETTER.
WE SAW IT WITH THE SCRAM AND I
EXPECT WE'LL SEE IT WITH OTHER
DEVICES.
WE EXPECT THAT TO CONTINUE TO
IMPROVE AND THERE'S EVIDENCE IT
HAS WITH THE FEW YEARS WE'VE HAD
THE SKIN FOR RESEARCH PURPOSES.
ASK NOW GOALS FOR DATA
INTERPRETATION AND WE HAVE TO BE
ABLE TO HAVE ACCESS THE DATA
QUICKLY AND PROCESS THE DATA
QUICKLY.
THAT'S NO SMALL FEAT AND WE NEED
MEANINGFUL OUTPUT WE CAN
INTERPRET.
THERE ARE ELEMENTS THAT MAKE THE
WORK CHALLENGING AND
ENVIRONMENTAL ARE THINGS LIKE
HAND SANITIZER, OTHER PRODUCTS
WITH ALCOHOL IN THEM AND SPILLED
DRINKS.
THIS IS ON YOUR ARM AND SO WITH
THE SCRAM WE STILL SEE
INTERFERENCE.
THE TOP FIGURE SHOWS THIS OVER
MULTIPLE DAYS.
THE VERTICAL LINE IS DAY BREAK,
THE BLUE LINES THE TAC.
YOU CAN SEE THEY GET UP QUITE
HIGH, 500 AND 600.
THIS FIGURE SHOWS SPIKES DURING
CONSUMPTION EPISODE.
KNOWING THIS WAS AN ISSUE AND
WOULD BE WE GATHERED DATA TO
CHARACTERIZE THE CURVES AND YOU
SEE WHAT HAS TO DO WITH THE
ALCOHOL DISSIPATING THROUGH THE
AIR.
WE ASKED PARTICIPANTS TO TELL US
WHETHER THEY USED HAND SANITIZER
AND THIS IS THEM THROUGH COVID.
AND ALSO WHILE THEY DRANK.
AND SO WE SELECTED THOSE
EPISODES OF KNOWN INTERFERENCE
THAT DIDN'T OCCUR WITHIN
CONSUMPTION EPISODES AND
COMPARED THE CHARACTERISTIC OF
THE OBSERVED CHARACTERISTICS AND
THEY WERE OBSERVED AND KNEW WHEN
THEY DRANK.
WE WERE ABLE TO DEVELOP A SET OF
CRITERIA THAT EXCLUDED A
PERCENTAGE OF THE INTERFERENCE
AND CATEGORIZE THEM AS
NOT-CONSUMED ALCOHOL.
THAT WIS FIRST SHOT AND WE
SHOULD BE ABLE TO MAP THAT AND
COME UP WITH THE BEST
CHARACTERISTIC FOR EXCLUDING
THOSE SO WE GET BETTER
IDENTIFICATION OF ALCOHOL
CONSUMPTION.
LET'S START WITH THE OBVIOUS
ISSUE.
THIS SHOWS MISSING DATA ROUGHLY
18 HOURS.
THESE ARE DAY BREAKS.
THIS IS MIDNIGHT.
WE HAVE CROSSOVER DURING
OVERNIGHT THAT HAPPENS WHEN THE
BRACELET'S TURNED OFF OR LOST
THE CHARGE OR THE DATA
COLLECTION MALFUNCTIONS.
I'M CONCERNED THIS BECAUSE
HERE'S AN ALCOHOL EPISODE THE
DAY BEFORE.
THAT'S IN EVIDENT ALCOHOL
EPISODE SAME TIME OF DAY AND WE
HAVE NO DATA.
THAT COULD BE A MISSED ALCOHOL
EPISODE.
IT'S MISSING DATA.
NOTHING YOU CAN DO.
THIS IS REALLY A PARTICIPANT
COMPLIANCE ISSUE.
ASSUMING IT'S NOT BRACELET
MALFUNCTION.
TEACHING PARTICIPANTS HOW TO
CHARGE AND SYNC AND WHAT THEY
NEED TO DO.
SO GOOD PRACTICES WITH TRAINING
PARTICIPANTS AND FOR RESEARCH
PURPOSES OR FOR ANY PURPOSES,
RIGHT.
THE SECOND TYPE OF MISSING DATA
OR PROBLEMATIC DATA IS MORE
DIFFICULT.
THIS IS HIDDEN INVALID DATA.
YOU HAVE TO IDENTIFY TIMES WHEN
THE PERSON ISN'T WEARING THE
BRACELET BUT IT'S NOT TURNED ON
AND IT'S NOT ON A PERSON SO YOU
CAN'T TRUST THE TAC.
THIS IS PART OF THE EPISODE OR
THIS PERSON'S DATA WHERE
TEMPERATURE'S VERY LOW.
IN THIS CASE AT 15 CELSIUS
THAT'S ROUGHLY 60 FAHRENHEIT.
WE HAVE LOW TEMP.
WE CAN PROBABLY IGNORE TAC AND
IT'S VERY FLAT SO I THINK IT'S
NOT A PERSON.
IT'S SITTING STILL.
THAT'S EIGHT HOURS.
WE NEED TO CREATE CRITERIA THAT
ESTABLISHES THIS AS INVALID.
WE'RE NOT CONFIDENT YET USING
ANY CRITERION FOR TEMPERATURE.
THE BAC TRACK COMPANY IS
CONTACTED AND YOU HAVE DIFFERENT
TEMPERATURE AND THEY VARY BY
TIME OF DAY AND SEASON AND
GEOGRAPHY.
TEMPERATURE'S GOING TO BE
TRICKY.
ULTIMATELY WE SHOULD GET TO A
POINT WHERE WE HAVE CRITERIA FOR
DETERMINING THIS IS -- AND THIS
IS IMPORTANT.
PEOPLE SAY SO WHAT, THERE'S NO
DRINKING THERE, RIGHT?
BUT IT'S ALSO NOT EVIDENCE OF
NOT DRINKING.
IF YOU HAVE A PROTOCOL WITH
OTHER REPORTS AND TRYING TO
STUDY ALCOHOL CRAVING AND AFFECT
AND OTHER THINGS YOU'RE TRYING
TO LEAD WITH AND WANT TO BE ABLE
TO SAY HERE'S DRINKING AND NOT
DRINKING, YOU CAN'T BE SURE
THAT'S NOT DRINKING.
THAT'S WHAT YOU HAVE TO WORK
THROUGH.
WE HAVE DECENT ACCEPTABILITY AND
GOOD RELIABILITY AND VALIDITY
BUT WE HAVE ISSUES.
WE HAVE SOME BIG BUTs AND WE
HAVE TO DO SOMETHING ABOUT OUR
BIG BUTs.
DID YOU LAUGH?
DID I CRACK YOU UP.
WE DON'T HAVE ESTABLISHED
CRITERIA FOR DETECTING ALCOHOL
USE WITH THE SKYN USING FIELD
DATA SO WE NEED TO EVALUATE
DIFFERENT CRITERIA AND USING
EMPIRICAL METHODS FOR EXCLUDING
BAD DATA IN THESE TIME SERIES
AND THE HOLEY GRAIL IS
TRANSLATING TAC TO BRAC.
ONE TOOL WE DEVELOPED YEARS AGO
WITH A TEAM AND PROGRAMMER WAS A
MACRO THAT WORKS IN EXCEL USING
VISUAL BASIC AND ALLOWS A USER
WITH SCRAM TO RUN THE DATA
THROUGH AND IDENTIFY THE CURVES
AND CALCULATE SOME
CHARACTERISTICS FROM THE CURVES.
WHAT WE NEEDED TO DO IN 2.0 WAS
TO MAKE IT WORK WITH THE SKYN.
THE SKYN'S MORE COMPLICATED.
WE ADDED FEATURES THAT ALLOW US
TO NOT JUST PRODUCE AREAS
CRITERIA BUT FIGURE OUTS THE
CRITERIA WE HAVE TO USE.
ALSO INCORPORATE EVENT-LEVEL
DATA IS GREAT WHEN YOU HAVE
MOMENTARY ASSESSMENT DATA OR
OTHER OBSERVATIONS YOU WANT TO
INTERWEAVE THEM BASED ON TIME
STAMP AND THAT COULD BE
DIFFICULT FOR EARLIER CAREER
FOLKS AND YOU WANT TO GET THINGS
DONE QUICKLY.
INCORPORATING THOSE EVENT-LEVEL
DATA ALLOWS US TO MORE QUICKLY
MAKE CONCLUSIONS ABOUT IT BUT
EVEN BEFORE THAT IS GOING TO
ALLOW US TO COMPARE DIFFERENT
CRITERIA SETS AND COME UP WITH A
SET THAT WORKS BEST FOR THIS
TOOL AND THE TOOLS THAT FOLLOW.
QUICKLY, THIS IS THE CURRENT
INTERFACE.
YOU CAN UPLOAD RAW DATA FILES IN
INDIVIDUALLY OR IN BATCHES, YOU
CAN ADD EVENT INFORMATION AND
ADJUST THE EPISODE DETECTION
CRITERIA.
THIS IS A TOOL TO HELP US TWEAK
AND TOGGLE AND TUNE SO THEN GET
DATA SETS WE CAN COMPARE ANDFIDE
WHICH ARE THE BEST.
WE HAVE FILTERS HERE TO FILTER
OUT THE HIGH PEAKS BECAUSE WE
THINK THERE'S INTERFERENCE.
YOU CAN SMITH OR GET NEGATIVE
VALUES OR ARE ALERTS VERSUS
FILTERS.
IT'S EXCITING TO BE ABLE TO HAVE
THIS TOOL TO SHARE WITH PEOPLE
WHO ARE USING THE SKYN
ESPECIALLY BECAUSE TOOLS LIKE
THIS WILL LOWER THE BAR A LITTLE
BIT FOR THOSE WHO WANT TO ENTER
THE SPACE.
IT'S CHALLENGING.
YOU LOOK AT THE DATA AND GO WHAT
DO I DO?
THE OUTPUT GIVES INTERACTIVE
GRAPHING AND ENUMERATES THE
EPISODES OF ALCOHOL AND PUTS
FLAGS ON THINGS YOU ASK IT TO
AND VISUALIZE BY EPISODE AND
DOWNLOAD DATA IN DIFFERENT
FORMATS AND WIDE OR LONG FOR
DIFFERENT SOFTWARE PACKAGES.
IT'S EVERYTHING WE THINK A USER
WOULD WANT BOTH TO WORK WITH
THEIR DATA AND FIGURE IT OUT AND
UNDERSTAND IT, VISUALIZE IT AND
WANT IT TO BE A FEEDBACK
MECHANISM AND CREATE A PLATFORM
FOR PEOPLE USING IT FOR
SELF-CHANGE OR TREATMENT OR FOR
PEOPLE TO BE ABLE TO SEE AS
CLOSE TO REAL TIME AS POSSIBLE
WHAT THE CONSUMPTION LOOKS LIKE.
SO ON TO HOW FOLKS ARE
ADDRESSING THE TAC TO BRAC
TRANSLATION.
THIS IS A PAPER FROM 2022 AND
MOST THE PAPERS ARE REALLY
RECENT.
THE PAST FEW YEARS HAS BEEN A
HOUSE OF FIRE.
THERE'S GREAT STUFF OUT THERE
INCLUDING FIVE REVIEWS DONE IN
2022 ALONE AND TWO IN 2021.
LOTS OF GREAT STUFF.
THIS IS A PAPER FROM 2022
SHOWING MACHINE LEARNING CAN BE
USED TO CONVERT TAC TO BRAC.
I HIGHLIGHTED SOME IMPORTANT
WORK IN THE ABSTRACT.
BIGGEST STUDY WE'VE HAD OF TRANS
DERMAL IN THE LAB WITH ALCOHOL
CONCENTRATION ADMINISTRATION AND
THE SKYN DEVICE IS DOING BETTER
AS WE MOVE THROUGH PROTOTYPES
WE'LL GET BETTER RELIABILITY AND
THE ESTIMATES FROM BRAC TO TAC
WERE CLOSE .01 TO .02 OF TRUE
BRAC READINGS IN THE LAB AND
FIELD RESPECTIVELY.
THIS IS GREAT NEWS.
MACHINE LEARNING WILL BE A GOOD
TOOL FOR THIS CONVERSION WE HAVE
TO DO.
NEXT WE USED PHYSICS AND
PHYSIOLOGICAL BASED MODELS TO
CALIBRATE FROM TAC TO AND FIRST
DOSE AN INDIVIDUAL LOOKING AT
THE RELATIONSHIP BETWEEN TAC AND
BRAC AND WHEN YOU SEE JUST TAC
YOU CAN PREDICT BRAC BUT IT
REQUIRED A CALIBRATION SYSTEM
AND NOW THEY'RE REPORTING ON A
MAGI
MATHEMATICAL APPROACH AND MAKE
IT MORE APPLICABLE AND HOPEFULLY
EASIER TO APPLY.
LIKE I SAID, CREATE TOOLS THAT
STANDARDIZE THE PROCESS.
WHAT WE NEED IS WE NEED TO BE
BEYOND ALL THIS.
WE NEED TO BE IN THE PLACE WHERE
WE HAVE THE DATA AND THE WHAT
THE DATA'S SAYING AND ALL AGREE
WE KNOW WHAT THE DATA'S SAYING
AND CAN TRANSLATE IT AND USE IT
IN DIFFERENT POPULATIONS WE'RE
INTERESTED IN.
SO THERE'S GREAT THINGS IN THE
PIPELINE.
ANOTHER TRANS DERMAL SENSOR
BEING TESTED AND LOOKING FORWARD
TO HAVING A CHANCE TO WORK WITH
THAT.
NOT YET WIDE LIE AVAILABLE AND
THERE'S TWO OTHERS.
THERE'S PATCHES.
YOU CAN LOOK IN THE LITERATURE
AND PATCHES AND TATTOOS AND A
SALIVA RING AND SMART GLASSES
AND MOST ARE IN THE DEVELOPMENT
PHASE.
WE HAVE A LOT TO LOOK FORWARD
TO.
SOME WORK WAS PRESENTED AT RSA.
THIS IS A MICRONEEDLE PATCH THAT
MEASURES ALCOHOL IN THE
INTERSTITIAL FLUID AND THERE'S
AN APP THAT CAN COLLECT THE DATA
AND THAT WAS PROOF OF CONCEPT AN
SOME FIELD WORK.
I'M LOOKING FORWARD TO THIS AND
TO HAVE ANOTHER OPPORTUNITY THAT
ISN'T EXACTLY THAT BUT CLOSE AND
UBE BE ABLE TO SEE HOW IT WORKS
AND THE ACCEPTABILITY.
THIS IS EXCITING.
AND THE NEXT THING, THIS IS A
LITTLE BIT FROM LEFT FIELD BUT
THERE'S WORK FROM THIS GROUP AND
THERE'S GREAT VIDEOS ONLINE.
THEY'RE DEVELOPING A PASSIVE
BREATH SYSTEM AND TOUCH SYSTEM.
THE TOUCH SYSTEM IS USING
OPTICAL SPECTOSCOPY AND WHEN YOU
PUSH THE BUTTON ON YOUR CAR TO
START IT WILL READ THE ALCOHOL
ON YOUR FINGER THROUGH THE
BUTTON AND IT WON'T LET THE CAR
START IF YOU HAVE ALCOHOL ON
BOARD BUT MORE SOPHISTICATED
BECAUSE ULTIMATELY -- AND WE CAN
ONLY DREAM IT WILL BE BUILT INTO
ALL OF OUR CARS LIKE A SEAT
BELT.
THE CAR WON'T WORK IF YOU HAVE
ALCOHOL ON BOARD.
THEY'RE TESTING THIS AND VIDEO
HOW THEY USED TO BE GOOD
MACHINES AND MINIATURIZED AND
THEY'RE MAKING PROGRESS AND
IMPLEMENTED THIS IN OM FLEETS OF
TRANSPORTATION VEHICLES.
THE TIME WAS TOO SHORT TO TALK
ABOUT ALL AND THIS HAS BEEN
SUCCESSFUL IN THE CRIMINAL
JUSTICE SYSTEM AND THE POTENTIAL
FOR REDUCING DRIVING FATALITIES
IS VERY HIGH BUT THERE'S OTHER
AREAS.
WE TESTED IT USING CONTINGENCY
MANAGEMENT AND MYSELF AND THE
DOHERTY GROUP AND THERE'S WE
TRACKED USED AND FOR PEOPLE WHO
HAVE AN ALCOHOL USE PATTERN
THAT'S NOT GOOD FOR THEM
GENERALLY AND A TALKED TO
COUNSELORS AND TREATMENT
PROVIDERS THEY SAID THEY THINK
THEY WOULD WELCOME THE TRACKING.
AND PEOPLE MAY BE STRUGGLING
WITH ACCOUNTABILITY,
INFORMATION, HELP IN RELAPSE
PREVENTION.
WE'RE NOT READY FOR JUST IN TIME
INTERVENTIONS BUT WE'RE HOPING
SOME WAY THERE WILL BE A WAY TO
ANTICIPATE SOMEONE'S AT RISK
BECAUSE OF WHERE THEY ARE OR
WHAT'S HAPPENING IN THEIR WORLD
OR PHONE AND COULD THEN WARN AND
DO IN THE MOMENT INTERVENTIONS.
THEN OF COURSE THERE'S MEDICAL
OR OTHER CLINICAL SETTINGS WHERE
ALCOHOL INTERFERES WITH A
CONDITION OR TREATMENT.
ALCOHOL INTERFERES WITH
MEDICATION ADHERENCE AND
HEALING.
THE LIST GOES ON AND ON AND THE
POTENTIAL EVEN FOR SHORT TIME OF
MONITORING LIKE PRE OR POST ARE
VERY GOOD.
SO I'M OUT OF TIME BUT I WANT TO
THANK NIAAA FOR INVITING ME AND
MY SCHOOL BROWN, AND MY CENTER
FOR ALCOHOL AND ADDICTION
STUDIES.
I HAVE INCREDIBLE SCIENTIST
COLLABORATORS WHO CONTRIBUTED TO
MY WORK AND SHARED THEIR DATA
AND INCLUDED ME IN THEIR WORK.
I WOULD POINT OUT THAT OVER HALF
THE PEOPLE ON THIS LIST ARE
EARLY CAREER SCIENTISTS WHO HAVE
BEEN SUPPORTED THROUGH NIAAA
THROUGH TRAINING OR CAREER
AWARDS.
SO THAT'S FANTASTIC.
THERE'S AN EARLY ADOPTER THING I
LOVE TO SEE.
I'M PLEASED I GET TO WORK WITH
SMART PEOPLE AND THANK YOU ALL
FOR LISTENING.
I'M HAPPY TO TAKE QUESTIONS.
>>THAT WAS WONDERFUL AND
FANTASTIC UPDATE ESPECIALLY FOR
ME.
AND WE WANTED TO MONITOR ALCOHOL
AND TOM GENTRY WHO ACTUAL LY
SHOWED US THE SHOE BOX THEY SHOW
IN PARTS OF THE GOVERNMENT AND
YOU PUT YOUR FINGER ON IT AND
GET YOUR INFRARED SENSOR THAT
MEASURED BLOOD ALCOHOL.
I'M NOT AWARE THE CAR SYSTEMS
WERE PART OF OUR DREAM WHICH
WOULD BE AN INFRARED SENSOR
WOULD BE SUBJECT TO LESS
VARIABLE THAN BLOOD ONES.
>>I'M WAITING FOR MY APPLE
WATCH BAND AND THEY'RE DOING --
THEY WANTING TESTERS.
THEY WANT PEOPLE TO HELP TEST.
I ORDERED ONE.
I'M GOING TO GIVE IT A SHOT.
>>GOOD FOR YOU.
I WANT TO RECOUNT SINCE I LIKE
TO TELL STORIES THAT WE INVITED
SCRAM PEOPLE TO MEET WITH US AND
THEY TOLD US THERE WAS
ABSOLUTELY NO WAY ON EARTH YOU
COULD EVER MINIATURIZE THE
SCRAN.
>>I TOLD THE CEO AT THE TIME --
I WAS THERE, IT WAS AN NIAAA
MEETING AND I SAID YOU'LL NEVER
GET RESEARCHERS TO TAKE IT ON
UNLESS YOU MINIATURIZE IT AND
THAT'S WHAT THEY WERE SAYING,
CAN'T YOU MAKE IT BE LIKE A FIT
BIT OR PUT IT ON MY ARM SORT OF
THING.
THAT WAS EVEN BEFORE THE DAYS OF
FULL-ON iPHONE SMARTPHONES.
I TOLD THEM THE SAME AND THE CEO
SAID THAT WOULD COST A MILLION
DOLLARS.
>>I HAVE ONE QUESTION AND WANT
TO SEE IF THERE'S COUNCIL MEMBER
QUESTIONS AND IT'S OKAY IF WE'RE
A LITTLE BIT LATE.
WE'LL BE FINE AND CATCH UP.
SO MY QUESTION IS HAS ANYONE
STARTED LOOKING AT A HEAD ON
HEAD COMPARISON BETWEEN TIME
LINE FALLBACK AND SAY THE BAK
TRACK DEVICE?
>>IT'S COMMON FOR PEOPLE
STUDYING USING THE SENSOR IN THE
FIELD.
YOU HAVE TO USE THE DAILY DIARY
AND I DID THAT IN MY STUDY AND
DAILY DIARIES -- I THINK THEY
ARE FINE MORNING YOU ASK
SOMEBODY WHEN DID YOU DRINK
YESTERDAY AND START AND FINISH
AND YOU CAN ASK IN THE MOMENT
AND PEOPLE WILL REPORT ON
ALCOHOL USE IN THE MOMENT BUT
GET NOT GOOD NEAR THE END AS
THEY HAD MORE TO DRINK AND
MISSED A COUPLE DRINKS AND MAY
NOT BE ABLE TO TELL YOU WHEN
THEY TOOK THE LAST DRINK.
YOU CAN ASK WHEN YOU DID YOU
HAVE THE FIRST SIP OF THE FIRST
DRINK AND LAST SIP OF THE LAST
DRINK AND YOU CAN COMPARE WHAT
THEY SAID TO WHAT YOU SEE.
TIME LINE I FALLBACK I DON'T
LIKE BECAUSE WEONCE YOU GET BEHD
AFTER A WEEK PEOPLE AREN'T VERY
GOOD AT SAYING WHETHER THEY
DRANK ON TUESDAY OR WEDNESDAY.
>>I CAN'T REMEMBER WHAT I ATE A
WEEK AGO.
>>YOU END UP WITH A REPORT THAT
SAYS TUESDAY AND A REPORT ON
WEDNESDAY.
DO YOU COMBINE THEM?
DO YOU BELIEVE ONE AND NOT THE
OTHER?
IT'S HARD TO KNOW WHAT IS TRUE.
I LIKE THE DAILY DIARIES.
PEOPLE ALSO SEND FOLKS OUT WITH
THE CHEAP BREATHALYZERS TO GET
BREATH IN THE FIELD AND YOU HAVE
THE SKIN.
YOU GET A LITTLE BIT MORE
ECOLOGICAL VALIDITY WITH THE
SKIN VERSUS THE LAB BECAUSE YOU
CAN'T DOSE PEOPLE UP TO HIGH
LEVELS AND AREN'T GETTING THE
PAVING OF THEIR DRINKING.
YOU'RE GETTING THE CONTINUOUS
WITH THE SKIN AND OCCASIONAL
VALUE FROM THE BRAC.
THERE'S GOOD MORE IN THE MOMENT
AND PREFER THAT TO TIME LINE
FALLBACK.
>>GOOD POINT.
ANYONE FROM COUNCIL HAVE
QUESTIONS OR COMMENTS?
I CAN'T SEE ALL THE HANDS SO --
WE NEED TO LOOK AT THE PATTERNS
OF DRINKING.
AND IT'S OBVIOUS HOW IT CAN
ADVANCE OUR RESEARCH.
>>FIVE YEARS FROM NOW WE'LL
HAVE ANOTHER BATCH OF OPTIONS
AND AS THINGS GET MINIATURIZED
WE'LL BE BETTER AT INTERPRETING
THE DATA WE DO HAVE.
I'M AN OPTIMIST AND GET EXCITED
AND GEEKY ABOUT IT BUT I FEEL
THE SAME AS YOU DO.
THE OPPORTUNITIES ARE ENDLESS
WHEN WE COME TO THE APPLICATIONS
OF THIS SORT OF TECHNOLOGY.
>>YOU'RE GETTING A LOT OF
COMMENTS IN THE CHAT.
WE HAVE TO RETURN TO REALITY,
EVERYBODY.
AND WE HAVE MORE DIRE
PATHOLOGIES ASSOCIATED WITH
ALCOHOL MISUSE.
PETER WILL GIVE A CONCEPT
CLEARANCE.
IT'S ALL YOURS.
>>THANK YOU.
>>MY NAME IS PETER GAO FROM
METABOLISM AND HEALTHY FAT AT
NIAAA.
THIS PRESENTATION IS TO SEEK THE
COUNCIL'S SUPPORT WITH THE
PROGRAM.
TO SET THE STAGE I'LL BEGIN WITH
BACKGROUND INFORMATION ON
ALCOHOL ASSOCIATED HEPATITIS AND
THIS PRESENTATION I MAY ALSO USE
ALCOHOL HEPATITIS OR AH FOR
WHICH WILL ASSOCIATED HEPATITIS.
AS YOU KNOW CHRONIC ALCOHOL USE
IS ASSOCIATED WITH A RANGE OF
LIVER DAMAGE FROM FATTY LIVER
DISEASE TO LIVER FIBROSIS AND
EVENTUALLY CIRRHOSIS.
A PERCENTAGE MAY DEVELOP
CARCINOMA.
IT'S IMPORTANT TO KNOW THERE'S
ALCOHOL ASSOCIATED LIVER
DISEASE.
IT'S DEFINED AS A CLINICAL
SYNDROME INCLUDING ACUTE AND
SEVERE LIVER INJURY.
SEVERE ALCOHOL HEPATITIS IS ONE
OF THE MOST SEVERE MANIFEST
MANIFESTATIONS WITH A 90-DAY
MORTALITY RATE AROUND 30%.
CURRENTLY THERE'S NO FDA
APPROVED DRUG FOR ALCOHOL
HEPATITIS.
OPTIONS ONLY INCLUDE SUPPORTIVE
CARE AND STEROIDS.
AND UNFORTUNATELY STEROIDS HAVE
NOT BEEN SHOWN TO IMPROVE
LONG-TERM SURVIVAL.
THE ONLY TREATMENT FOR ALCOHOL
HEPATITIS IS LIVER
TRANSPLANTATION.
BUT LIVER TRANSPLANTATION
REMAINS A SIGNIFICANT CHALLENGE
DUE TO THE SHORTAGE OF ORGAN
DONORS.
THE NUMBER OF ALCOHOL HEPATITIS
RELATED HOSPITALIZATIONS HAS
SIGNIFICANTLY INCREASED IN
RECENT YEARS.
AND THERE'S MANY REASONS FOR
THIS INCLUDING THE OVER ALL
INCREASE IN ALCOHOL CONSUMPTION
IN RECENT YEARS AND STRESSORS
SUCH AS COVID-19 EPIDEMIC.
THEREFORE THERE'S DIRE NEED TO
DEVELOP SAFE AND EFFECTIVE
THERAPIES FOR ALCOHOL HEPATITIS
PATIENTS.
OTHER THAN THAT WHAT IS HAPPEN
SINCE 2012 AND THROUGH 2018 THE
GROWTH INCLUDED A STUDY IN
DISEASE MECHANISMS AND THERAPIES
FOR ALCOHOL HEPATITIS.
AND NIAAA HAS A CLINICAL PROJECT
TO STUDY ALCOHOL HEPATITIS.
THE FOCUS HAS SHIFTED TO
CLINICAL RESEARCH.
THERE ARE SITES FOR CONDUCTING
CLINICAL RESEARCH.
I WOULD LIKE TO TALK ABOUT THE
ANTAGONIST DRUG APPROVED BY FDA
FOR TREATING DISEASES AND
THERE'S AS A PHASE II TRIAL WITH
PATIENTS WITH SEVERE ALCOHOL
HEPATITIS.
PATIENTS WERE RANDOMIZED 1:1.
AND THE PRIMARY END POINT WAS 90
DAY SURVIVAL.
DESPITE THE CHALLENGES DURING
THE COVID-19 PANDEMIC, THERE WAS
A STUDY BUT THE TRIAL WAS
STOPPED AFTER AN INTERIM
ANALYSIS LAST YEAR.
THIS INTERIM ANALYSIS SHOWS
HIGHER OVER ALL SURVIVAL IN THE
CONTROL ARM AND HIGH INCIDENTS
IN THE EXPERIMENT ARM.
NOW I'D LIKE TO LOOK AT THE
ACHIEVEMENT OF THE TRIAL.
FIRST, IT DEMONSTRATE THE
CLINICAL TRILS IN SEVERE
HEPATITIS AND SUCCESSFUL
ENROLLMENT.
SECOND, PUBLISHED DIAGNOSTIC
CRITERIA AND COMMON DATA
ELEMENTS TO HARMONIZE CLINICAL
TRIAL OF WHICH WILL HEPATITIS IN
2016.
SINCE THEN THE NUMBER OF ACTIVE
CLINICAL TRIALS FOR ALCOHOL
HEPATITIS INCREASED.
THERE'S ALSO SOME LESSONS OR
EXPERIMENTS WE CAN LEARN FROM
THIS.
THERE'S A HIGHER THAN 90-DAY
SURVIVAL RATE IN THE PREDNISONE
CONTROL RATE AND COVID-19
PANDEMIC MAY HAVE IMPACT ON
PATIENT ENROLLMENT AND THE
DIRECTION.
I'D LIKE TO TALK ABOUT THE
FUTURE DIRECTION.
WHEN THINKING ABOUT ALCOHOL
HEPATITIS IT'S IMPORTANT TO
APPROACH THIS AS TWO DISEASES.
ALCOHOL USE DISORDER AND ALCOHOL
LIVER DISEASE.
ALCOHOL USE DISORDER OR AUD IS
CHARACTERIZED BY COMPULSION TO
CONSUME ALCOHOL.
THE CONTINUED USE OF ALCOHOL IS
OFTEN VIEWED AS AUD.
TREATMENT CAN REDUCE HOSPITAL
ADMISSION AND ALCOHOL RELAPSE IN
ALCOHOL HEPATITIS PATIENTS.
AND IN THE STUDY, IT'S FOUND
LESS THAN 8% OF AH PATIENTS
RECEIVED MEDICATION TO PREVENT
RELAPSE OF USE.
WHILE EMERGING EVIDENCE IS
SUGGESTING TREATMENT FOR AUD
ASSOCIATED WITH ALCOHOL LIVER
DISEASE STUDIES ARE NEEDED TO
ADDRESS THE AUD TREATMENT ON AH
OUTCOMES.
WE NEED TO BUILD COLLABORATIONS
BETWEEN PHARMACOLOGISTS AND
ADDICTION MEDICINE SPECIALISTS.
STUDIES ARE NEEDED TO LOOK AT
TOXICITY FOR MEDICATION FOR AUD
WITH AH PATIENTS.
IN THE NEXT FIVE YEARS, WE'LL
HAVE CLINICAL TRIALS ON THE
INTERVENTIONS AND TREATMENTS FOR
AUD AND AH.
IT WILL ALSO USE A MORE
ADAPTIVE -- IT WILL USE MORE
ADAPTIVE TRIAL DESIGN AND
DECENTRALIZE THE TRIAL MEASURES.
WE KNOW AS THE CREATED HIGH
QUALITY DATA AND THAT'S WHAT WE
WANT TO MAKE THE DATA MORE
ACCESSIBLE TO RESEARCHERS
INCLUDING TO RESEARCHERS FROM
OUTSIDE ALCHEPNET AND PLAN TO
HAVE A CENTER TO MONITOR THE
CLINICAL TRIAL PROGRESS AND
PROVIDE PATIENT SUPPORT.
THIS CONCLUDES OUR PRESENTATION
ON ALCHEPNET AND NOW WELCOME
QUESTIONS AND COMMENTS FROM THE
COUNCIL.
>>THANK YOU, PETER.
THAT WAS AN EXCELLENT
EXPLANATION OF WHERE YOU'VE BEEN
AND WHERE YOU WANT TO BE.
WE ALREADY HAVE QUESTIONS
RAISED.
LAURA NAGY.
>>I'M PLEASED YOU'RE ALL
WORKING TO EXTENT THE ALCHEPNET.
THE WORK DONE IN THE LAST TWO
ROUNDS HAS BEEN OUTSTANDING.
I HAVE A FEW QUESTIONS ABOUT
MOVING FORWARD.
PETER, I THINK YOU MENTIONED
THAT THERE'S DATA -- THE
QUESTION GOES TO WHETHER IT'S
JUST MEDICATION TREATMENT OR
WHETHER COGNITIVE BEHAVIORAL
THERAPIES WOULD BE ALSO PART OF
THE ONGOING TRIALS BECAUSE YOU
MENTIONED MORE MEDICATIONS THAN
BEHAVIORAL THERAPIES.
>>THANK YOU FOR YOUR QUESTION.
FOR FUTURE DIRECTION I THINK THE
INTERVENTION ARE TREATMENT FOR
AUD WILL INCLUDE BOTH
PHARMACEUTICAL AND
NON-PHARMACEUTICAL APPROACHES
INCLUDING THERAPIES.
>>AND MY SECOND QUESTION HAS TO
DO WITHIN THE PAST THE NIAAA
FUNDED TRANSLATIONAL STUDIES IN
PARALLEL WITH THE CLINICAL
TRIALS AND I THINK THAT IS REEL
HAS MOVED THE FIELD FORWARD IN
TERMS OF BIO MARKERS AND
MECHANISMS.
I'M WONDERING IF TRANSLATIONAL
STUDIES ARE PART OF THIS CONCEPT
CLEARANCE.
>>FIRST OF ALL, NOTHING HAS
BEEN DECIDED YET FOR THE NEXT
FIVE YEARS BUT AS MENTIONED IN
THE PREPARATION THE RESEARCH
DIRECTION HAS SHIFTED TOWARDS
CLINICAL RESEARCH.
THE PREVIOUS UL 1s MAY SUNSET IN
THE FUTURE THE RESEARCHERS HAVE
ALTERNATIVE FUNDING MECHANISM TO
COLLABORATE TO USE THE DATA AND
USE THE BIO SAMPLES.
>>THANK YOU.
>>I'LL MENTION, LAURA THAT I
THINK THIS IS ALSO AN
OPPORTUNITY AND IT WILL BE
DISCUSSED IN THE FUTURE BUT FOR
BAC TRANSLATION.
SHOULD EVIDENCE COME FROM THE
CLINICAL STUDY IT COULD BE MOVED
BACK TO THE ANIMAL MODELS TO
VALIDATE SOME OF THE ANIMAL
MODELS.
IT'S SOMETHING IN THE BACK OF MY
MIND AT LEAST.
SO THE NEXT PERSON UP I THINK IS
CONNIE.
>>YOUR MUTED.
>>THANK YOU VERY MUCH.
WHAT A GREAT PRESENTATION AND
OVERVIEW OF THINGS.
THIS IS MY LAST COUNCIL MEETING
I'LL BE AT SO MY WORDS ARE WHAT
A PERFECT OPPORTUNITY THIS WHOLE
AREA PROVIDES FOR HEALTH
SERVICES RESEARCH AND FROM THE
PERSPECTIVE OF HOW CAN THE
SYSTEM BE DESIGN TO ACCOMMODATE
WHAT OTHER INSURANCE PLANS ARE
TWO SEPARATE BENEFITS.
MEDICAL AND BEHAVIORAL HEALTH
BENEFIT.
I JUST WANT TO MAKE A COMMENT
THAT THERE ARE SYNERGIES WITH
THIS KIND OF RESEARCH AND ALSO
THE SERVICES ANGLE OF HOW WE CAN
GET THIS INTO THE REAL WORLD OF
THE DELIVERY SYSTEM.
THOSE ARE A FINAL COMMENT AS
IT'S AN OPPORTUNITY.
>>AS THEY SAY IN FRIEND, BIEN
ETENDU.
WELL UNDERSTOOD.
>>WE NEED AN OFFICIAL ACTION
AND I WOULD APPRECIATE IF ONE OF
THE COUNCIL MEMBERS MAKES A
MOTION TO APPROVE THE CONCEPT
AND CONCUR OR NOT IN THE CHAT
THAT WILL BE HELPFUL TO CAPTURE
THE SENTIMENTS.
>>SO MOVED.
>>KATIE MOVED IT FOR YOU.
>>THANK YOU.
THE NEXT ITEM ON THE AGENDA IS
THE CONSIDERATION OF THE
PREVIOUS COUNCIL MEETINGS, 161st
COUNCIL MEETING HELD IN
SEPTEMBER.
THE MINUTES WERE POSTED IN THE
ELECTRONIC COUNCIL BOOK.
DO ANY OF THE COUNCIL MEMBERS
HAVE ANY COMMENTS, CORRECTIONS
OR REVISIONS?
IF NOT I'LL APPRECIATE A MOTION
TO ACCEPT IT AS APPROVED.
>>SO MOVED.
NOW IT'S TIME FOR COUNCIL
DISCUSSION.
>>THANK YOU FOR PARTICIPATING
TODAY.
YOU HEARD SOME REALLY EXCELLENT
PRESENTATIONS.
IT'S REWARDING TO ME BECAUSE I
REMEMBER WHERE WE WERE AND SEE
WHERE WE ARE AND IT'S NICE TO
SEE THE PROGRESS AND QUESTIONS
FROM YOU ALL FROM DATA
MANAGEMENT TO ANYTHING YOU CAN
ASK ABOUT THE BUDGET AND I CAN
TELL YOU WHAT I DON'T KNOW.
IS THERE ANYTHING FROM ANYBODY
OR ANYTHING WE'RE NEGLECTING OR
AREAS THAT CAN USE MORE
EMPHASIS?
ANY COMMENTS ABOUT HARM
REDUCTION?
I HAD A MEETING WITH BOB DUPONT
WHERE HE WAS TRYING TO TELL ME
WE WERE NEGLECT IN NOT PURSUING
HARM REDUCTION AND REMINDED HIM
IT WAS ADDRESSED 40 YEARS AGO
AND PULLED THE PAPERS UP TO SHOW
HIM.
BUT I ALWAYS LIKE DISCUSSIONS
WITH BOB.
HE STIMULATES ME TO THINK ABOUT
THINGS.
KATIE.
>>THAT WAS ONE THING I WAS
GOING TO RAISE I ALWAYS THOUGHT
NIAAA WAS A PLACE FOR HARM
REDUCTION AND NIDA NOT AS A
PLACE FOR HARM REDUCTION AND
THAT'S SHIFTED RECENTLY WHERE I
THINK NIDA IS MOVING IN THAT
DIRECTION OR MORE RECOGNITION OF
NEED FOR HARM REDUCTION AND
COMMUNITY-ENGAGED WORK AND
TRYING TO MAKE SURE OUR WORK IS
CENTERED IN PEOPLE'S EXPERIENCE
WITH SUBSTANCES.
I'M CURIOUS IF NIAAA HAS COME
TOGETHER WITH NIDA ON ANY OF
THOSE IDEAS OR INTERESTED IN
PURSUING BEING MORE EXPLICIT
ABOUT THE NED FOR HARM REDUCTION
RESEARCH.
>>IS RAY ON?
>>YES.
>>DO YOU WANT TO ADDRESS WHAT
WE'RE DOING IN TREATMENT AND
RECOVERY.
I CAN START TRYING TO GO THROUGH
THE LIST OF THINGS WE'RE DOING
IN HARM REDUCTION BUT ONE YOU
MIGHT MENTION IS YOUR
INTERACTIONS WITH THE FDA ON
OUTCOMES.
I THINK SOCIAL DETERMINATES IS
ONE AND THE MODELS OF CONTINUUM
OF CARE.
>>GENERALLY WHAT WE ARE
RECOMMENDING AND AGAIN IT'S A
CORE RESOURCE IS WE WOULD LIKE
TO SEE IT FOLLOW THE ONE OR TWO
DRINKS A DAY BUT IN MANY CASES
PEOPLE CAN'T DO THAT SO WE FOUND
IF WE CAN JUST GET THEM REDUCE
THEIR DRINKING IT THE IMPROVE
HOW THEY FEEL AND FUNCTION AND
SOMETHING WE'RE TRYING TO GET
THROUGH THE FDA FOR MEDICATION
DEVELOPMENT TRIALS AS A PRIMARY
END POINT FOR THE FDA.
ACTUAL KATIE'S BEEN INVOLVED IN
ANALYSIS AND WE'VE DONE SEVERAL
DATA SETS WITH THAT AND HAVE
COMBINED AND TWO TRIALS ON
GABAPENTIN AND THERE'S STUDIES
THAT SHOW IF YOU DO REDUCE YOUR
DRINKING YOU CAN IMPROVE THE WAY
YOU FEEL AND FUNCTION.
SOMETIMES YOU CAN'T ALWAYS GET
PEOPLE TO STOP THEIR DRINKING
BUT JUST CUTTING BACK WOULD
IMPROVE THE SITUATION.
>>THANK YOU.
I APPRECIATE IT.
>>NOT TO BE SNARKY KATIE BUT
DOING 60 INTERVIEWS ON DRY
JANUARY FROM MY PERSPECTIVE IS
HARM REDUCTION.
I WOULD LIKE TO SAY WE'RE WAY
AHEAD OF NIDA IF YOU WANT TO
KNOW.
>>I APPRECIATE THAT.
YOU DON'T HAVE TO RAISE THAT AT
THE NEXT MEETING.
THANK YOU.
>>I APPRECIATE YOU DOING THE
INTERVIEWS AND HOW NIAAA WAS
REPRESENTED IN THE MEDIA SO
STRONGLY AND SOCIETY'S STARTING
TO OPEN UP TO POSSIBILITIES OF
DRINKING REDUCTION AND MORE
HEALTH SERVICES AND EVEN TAKING
TIME OFF.
>>ON A SERIOUS NOTE I WANT YOU
TO KNOW THE WAY -- WHEN THEY
ASKED ME, I INTERPRET THE
USEFULNESS OF DRY JANUARY IN A
HARM REDUCTION VEIN.
FANCY, YOU HAD A QUESTION.
>>THANK YOU.
THIS IS KIND OF SCIENTIST ON THE
STREET QUESTIONS.
SORT OF BRINGING THE QUESTIONS
HERE THAT I'VE BEEN HEARING FROM
FOLKS AND I'M HOPING YOU CAN
COMMENT ON TWO.
ONE IS THE INFORMATION/CONCERN
I'M HEARING FROM PEOPLE TRYING
TO GET SECOND NO-COST EXTENSIONS
THEY'VE BEEN DIALED BACK OR
GOTTEN TURNED DOWN FOR THEM.
THE OTHER IS THE CHALLENGES
PEOPLE ARE HAVING WITH THE DATA
SHARING REQUIREMENT.
I SPEND A LOT OF TIME WITH
ASSIST AND THE PROFESSORS.
IT'S BEEN QUITE DIFFICULT TO
WORK WITH THE AVAILABLE TOOLS
AND UNDERSTAND THE LIMITATIONS,
ETCETERA.
I DON'T KNOW IF YOU HAVE
ADDITIONAL INSIGHT ABOUT EITHER
OF THOSE ISSUES THAT I COULD
BRING BACK TO FOLKS I KNOW.
>>PHILIPPE, DO YOU WANT TO
ADDRESS THE NO-COST ISSUE AND
PHILIPPE HAS STOOD IN FOR ABE
AND IF HE CAN'T ANSWER WE'LL GET
BACK TO YOU ON THAT.
PHILIPPE?
>>I'LL FOLLOW YOUR
RECOMMENDATION I'LL PROBABLY
NEED TO GET MORE INFORMATION
ABOUT THE NO-COST EXTENSION TO
GIVE AN EDUCATED ANSWER.
IF YOU HAVE ANY SPECIFIC
QUESTION ABOUT IT, I'LL GET BACK
TO YOU AND GIVE AN APPROPRIATE
ANSWER.
>>AND TO ADD DETAIL, RUMORS ARE
THAT SECOND NO-COST EXTENSIONS
ARE VERY RESTRICTIVE BACK TO
SHORT PERIOD OF TIME AND SAYING
YOU'RE WORK WAS DELAYS BECAUSE
OF COVID IS NOT A GOOD REASON.
I'VE HEARD THAT.
I COULDN'T KNOW IF THAT'S
ACCURATE OR NOT.
THAT'S WHAT I HEARD AND I THINK
THAT'S PROBLEMATIC.
WE ALL KNOW COVID STILL
HAPPENING AND HAS A LONG TAIL
AND EVERYTHING'S DELAYED TWO
YEARS AGO IS NOW TRYING TO
HAPPEN NOW AND I THINK THERE'S A
RULE ABOUT COVID IS AN EXCUSE
FOR NOT HAVING RUN YOUR TRIAL OR
COLLECTED ALL THE DATA.
THAT'S GOING TO BE CHALLENGING
FOR PEOPLE.
>>AND CAN I ADD THE DERIVATIVE
DOWN STREAM EFFECT BECAUSE IF
YOU TALK TO ANY LARGE
INSTITUTION IN HEALTH CARE OR
RESEARCH, PEOPLE AREN'T APPLYING
FOR JOBS STILL.
THERE'S AN ENORMOUS MANPOWER
SHORTAGE.
>>IT'S HUGE AND HAS TRICKLE
DOWN EFFECT AND YOU CAN'T HIRE
PEOPLE TO HELP YOU COLLECT YOUR
DATA.
IT CAUSES REAL DELAYS THAT ARE
NOT DUE TO THE INVESTIGATOR
FAILING TO MEET THE AIMS OF THE
PROJECT.
>>WE HEAR YOU.
LET US LOOK INTO.
IT WAS NOT AWARE OF IT SO THAT'S
WHY WE HAVE A COUNCIL.
WE'LL SEE WHAT WE CAN COME UP
WITH AND IF WE GET AN ANSWER,
FELIPE WILL SEND AN E-MAIL AND
WE'LL LET RSA KNOW IF IT'S
SOMETHING WE CAN SHARE THAT WAY.
AND THEY'VE BEEN VERY GOOD,
LATELY, RSA, IN DISSEMINATING
INFORMATION FOR EVERYBODY.
ON DATA MANAGEMENT, TRISH, I
DON'T KNOW WHO COULD ANSWER THE
QUESTION ON THAT.
RIGHT NOW AS I UNDERSTAND IT,
YOU NEED TO HAVE A PLAN.
>>I JUST MET WITH BOTH OF OUR
INTEGRATIVE NEUROSCIENCE
INITIATIVE ON ALCOHOLISM
CONSORTIA IN THE LAST TWO WEEKS
AND THEY'RE WORKING ON CURATING
AND LEARNING HOW TO CURATE DATA
THEY USE IN COMMON HARMONIZING
DATA, SETTING UP REPOSITORIES.
IT'S KIND OF A WORK IN PROGRESS.
>>WE'RE CERTAINLY ON THE
LEARNING CURVE BUT SOME FOLKS
WILL TAKE THE BRUNT OF IT.
>>IF IT'S CLINICAL DATA,
CONTACT DAN FOGG.
NOT ONLY CAN HE BE HELPFUL BUT
PEOPLE CAN GET SUPPLEMENTS IF
THEY NEED ADDITIONAL HELP EARLY
ON IN GETTING THAT DATA FLOAT
UPLOADED IN THE SYSTEM AND THE
DATA ARCHIVE.
AS GEORGE MENTIONED FOR OTHER
STUDIES RIGHT NOW IT'S HAVING
THE PLAN AND GETTING PEOPLE TO
PUT A PLAN IN PLACE SO WE CAN
MOVE IN THAT DIRECTION.
>>THANK YOU.
>>STAY TUNED ON THE LATTER ONE
AS TRISH SAID.
I HAVE A LAB AND PUT TOGETHER A
PLAN FOR THE INTRAMURAL
RESEARCH.
I'M WORKING BOTH ENDS.
>>AS DID I FOR A FEBRUARY
SUBMISSION AND TALKING TO PEOPLE
WITH BEHAVIORAL DATA THAT'S KIND
OF COMPLEX OR MAYBE NOT
APPROPRIATE FOR SHARING.
I'M WORRIED ABOUT
RE-IDENTIFICATION AND A WENT TO
A WHOLE WEEKEND ON PRIVACY AND
RE-IDENTIFICATION OF DATA.
IT'S REALLY GRIM HOW QUICKLY
DATA CAN BE RE-IDENTIFIED AND
I'M NOT AN EXPERT ON THIS, I
JUST WENT, OH, NO.
>>WHY DON'T YOU CONTACT DAN.
>>I'D LIKE TO MAKE AN ELABORATE
COMMENT ABOUT THIS.
I SPOKE WITH THEM ABOUT 45
MINUTES AND APPRECIATED IT.
GREAT GUY AND VERY PATIENT AND
LISTENED TO A LOT OF GRIPINGS
FROM ME AS WE ARE TRYING TO
SQUASH OUR DATA INTO THIS.
I WAS GOING SIT ON MY HANDS AND
NOT COMMENT NOW BECAUSE I DON'T
LIKE DISCUSSIONS ON ZOOM.
WHAT I WOULD APPRECIATE PERHAPS
IF THERE'S ROOM FOR IT AN
IN-PERSON COUNCIL TO HAVE A MORE
IN-DEPTH CONVERSATION ABOUT THIS
BECAUSE WHILE I THINK IT'S A
GREAT IDEA ABSTRACT.
THERE'S ENORMOUS AMOUNT OF
COMPLICATIONS AND ALREADY ERRORS
IN THE DATABASE AND I DON'T
THINK THE DATA WILL PROVE TO BE
AS USEFUL AS MANY MANY PEOPLE
IMAGINE THEM TO BE BECAUSE OF
THE DIFFERENT WAYS THEY'RE
ENTERED IT'S REALLY COMPLEX AND
NOT EASY TO COMPLY WITH.
I'LL ASK IF WE CAN HAVE A GOOD
IN-PERSON CONVERSATION PERHAPS
IN MAY IF IT SUITS THE AGENDA OF
NIAAA.
>>I DON'T SEE WHY NOT.
WE HAVE TWO DAYS IN MAY AND WILL
HAVE OUR OWN COUNCIL LIKE WE'RE
DOING AND THE CRAN MEETING.
DULY NO
CALL
DU
DUALLY NOTED.
WE CAN HAVE A WORKSHOP AND ALL
KINDS OF THINGS.
I THINK IT'S GOING TO BE A
CHALLENGE.
KNOW THAT EVERYBODY'S IN THE
SAME BOAT AND THERE'S A GOOD BIT
OF ANGST OUT THERE ABOUT IT I
DON'T THINK ANYBODY'S IN ANY
WORSE SHAPE IN THIS REGARD.
IN MY OWN LAB I'M TRYING TO
BASICALLY NOT WORRY IS WHAT I'M
TRYING TO SAVE TO YOU.
I THINK THERE'LL BE BENEFITS AND
DOWN SIDES WHEN THERE'S A BIG
SHIFT.
SPEAKING OF, THERE'LL BE SOME
SHIF
SHIFTS COMING DOWN WITH HOW WE
REVIEW GRANTS AND SIGNIFICANCE
AS A CRITERIA AND I'VE BEEN FOR
THAT FOR YEARS AND NONI BARNES
BEEN WORKING ON THAT AND MAYBE
THAT'S SOMETHING FOR A FUTURE
COUNCIL TO HAVE HER TALK OR HER
DEPUTY TO GET OUT TUNED UP AS TO
NOW THE NEW CRITERIA WILL WORK
AND WHAT THE ARE EMPHASIS ARE
GOING TO BE.
>>I THINK GETTING FEEDBACK
MEANS WE HAVE TO LOOK AT WHAT IT
REQUIRES AND MAYBE A DIVERSITY
WORK GROUP OR MAYBE IN-PERSONAL
MEETINGS BUT THOUGHT I'D ASK
ABOUT THE STATUS OF THAT AND
HIGHLIGHT THAT AS AN EXAMPLE OF
THE CHALLENGES.
>>IT'S A VERY GOOD QUESTION AND
WE SHOULD BRING THAT GROUP BACK
EVEN THE PEOPLE WHO GRADUATED
FROM COUNCIL.
TWO THINGS HAPPENED.
COVID AND UNIT.
ONE WAS BAD AND ONE WAS GOOD.
WE'VE DONE QUITE A LOT ABOUT
UNITE.
WE WANTED TO GET UNITE AND REAP
AND MAYBE YOU CAN EXPLAIN WHAT
REAP IS STRAIGHTENED OUT AT
NIAAA BEFORE WE RETURN TO OUR
PAROCHIAL INTERESTS.
I THINK YOU RAISE A GOOD POINT.
WE HAVE PAROCHIAL INTERESTS, LAW
RARKS THAT COULD BE ADDRESSED
AND WHERE WE COULD MOVE THINGS
FORWARD NOW THAT WE KNOW WHAT WE
KNOW.
BRIDGETTE.
>>I THINK NOW THAT THINGS ARE
GETTING MORE SETTLED WE'RE ABLE
TO FOCUS ON SOME OF THE THINGS
WE WERE DOING BEFORE.
IT'S IMPORTANT TO HAVE A
COORDINATED EFFORT AND NOT
DUPLICATE THINGS.
AS GEORGE MENTIONED THE RACIAL
ETHNIC AND EQUITY PLAN WHICH IS
A RECOMMENDATION FROM THE UNITE
COMMITTEE AND EACH NIH INSTITUTE
HAS ONE TO IMPROVE DIVERSITY,
EQUITY AND INCLUSION AT THE
CENTERS.
THAT'S SOMETHING WE'VE BEEN WORK
ON A LOT INTERNALLY.
THERE'S DIFFERENT STRATEGIES AND
METRICS INVOLVED AND OVER ALL
THERE'S BEEN SO MANY THINGS
GOING AND WE'RE TO THE POINT
WHERE WE CAN BE MORE STRATEGIC
IN WHAT WE'RE DOING.
THANKS FOR BRINGING THAT UP.
>>AND WE'VE BEEN SIGNING ON TO
EVERYTHING JOHN LORSCH AND THE
BRAIN INITIATIVE IS BRAVE ENOUGH
TO PUT OUT THERE.
>>CAN I REMIND PEOPLE TOO WE'LL
BE HIRING A CHIEF DIVERSITY
OFFICER.
PLEASE SPREAD THE WORD BROADLY
TO ANYONE YOU KNOW OR YOURSELVES
WHO MAY BE EXCELLENT IN THAT
POSITION.
THAT PERSON WHILE THEY WON'T BE
TASKED WITH DOING EVERYTHING WE
DO AROUND DIFFEVERSITY, EQUITY,
INCLUSION AND ACCESSIBILITY,
WILL BE HELPING US COORDINATE
THOSE EFFORTS AND THAT INCLUDES
BRINGING BACK OUR EXTERNAL
EXPERTS TO CONTINUE TO ADVISE
US.
WE GET TREMENDOUS ADVISE ABOUT
THE IMPORTANCE OF MENTORING FROM
THE FIRST MEETING.
WE KNOW WE LEARN A LOT.
IT'S JUST NA AS BRIDGET SAID
WE'VE BEEN BUSY WITH THE UNITE
ACTIVITIES AN WANT TO HIRE THE
COORDINATOR AND LET THAT PERSON
BE INVOLVED IN THE PHASES OF
THIS.
>>TO PIGGY BACK ON WHAT TRISH
IS SAYING, THE IDEA OF WHAT
MENTORSHIP IS CONTINUED TO
EVOLVE.
WE WELCOME THAT INPUT.
WHEN WE RECONVENE SOME WILL WANT
TO BE PART OF THE GROUP AND
WE'LL WELCOME YOUR
CONTRIBUTIONS.
WE'LL ACT ON THAT ONE AS SOON AS
WE CAN LAURA.
VICKY SAYS -- VICKY BUCKLEY PUT
IN HE CHAT THE DIVERSITY,
EQUITY, INCLUSION AND
ACCESSIBILITY LINK AND OTHER
QUESTIONS OR COMMENTS?
YOU GUYS ARE COMING UP WITH GOOD
ONES SO KEEP IT UP.
HAPPY TO ENTERTAIN ANY THOUGHTS.
WE'RE NOT OFF OUR TIME LINE FOR
THE END DEPENDING ON WHO HAS TO
GO AND WHERE THEY HAVE TO GO.
ANY OTHER ISSUES WE'VE
NEGLECTED?
>>ALL RIGHT.
NOW WE'LL INTRODUCE THE RETIRING
MEMBERS AND LET THEM SPEAK IF
THEY WANT TO SAY ANYTHING.
>>I HAVE A SPEECH FOR YOU AND
THEN I'D LIKE TO HEAR FROM JILL
AND CONNIE AND SCOTT.
I'D LIKE ANY THOUGHTS YOU HAVE.
AND THANK YOU FOR SERVING AS
MEMBERS OF THE NATIONAL ADVISORY
COUNCIL ON ALCOHOL AND
ALCOHOLISM.
THE SUCCESS OF THE INSTITUTE HAS
BEEN IN LARGE PART DUE TO THE
WILLINGNESS OF PEOPLE LIKE YOU
TO PARTICIPATE IN ADVISORY
COMMITTEES.
WE APPRECIATE HOW MANY HOURS YOU
SPENT IN PREPARATION FOR
MEETINGS AND OTHER ACTIVITIES.
SACRIFICING YOUR OWN INTERESTS
TO FACILITATE OPERATION.
I ENCOURAGE YOU TO GIVE THOUGHTS
AND GIVE TOMATOES OR HIGH
PRAISE.
WE LOVE HIGH PRAISE.
YOU CAN POINT TO US DIRECTIONS
MAYBE WE NEGLECTED.
JILL, YOU'VE BEEN WONDERFUL AND
EVEN DID DID IT TODAY, I WAS
PLEASED.
YOU MADE SURE WE'RE CONTINUING
WITH THE ANIMAL AND HUMAN AND
EVERYTHING IN BETWEEN WORK
WITHBOTH GENDERS AND SEXES.
I MAY ADD I'VE BEEN HARPING ON
THIS FOR THE REPORT WITH OUR
CONSORTIA BECAUSE I SEE THE
TENDENCY IN THE FIELD THEY GET A
DIFFERENCE BETWEEN MALES AND
FEMALES -- I DON'T KNOW IF YOU
PICKED UP ON THIS.
THEY GO BACK TO THEIR DEFAULT
RESEARCH AND I'LL WORK ON THE
MECHANISM IN THE MALES AND
MAKING IT CLEAR WHAT WE WANT
THEM TO DO IS WORK ON THE
MECHANISM OF THE MALES.
JILL.
>>THANK YOU.
IT'S BEEN AN HONOR AND PRIVILEGE
TO SERVE ON THIS COUNCIL.
I'VE APPRECIATED BEING PART OF
THE NIAAA ADVISORY COUNCIL THE
LAST FOUR AND APPRECIATE THE
THOUGHT YOU GIVE TO THE PROJECTS
BEING FUNDED BY THE NCAAA.
AND MAKING SURE THE INSTITUTE IS
PAYING ATTENTION TO THE GRANTS
BEING CONDUCTED CONSIDERING BOTH
SELVES HAS BEEN SOMETHING YOU
TASKED ME WITH WHEN YOU ASKED ME
TO BE PART OF THE COUNCIL AND I
TOOK THAT ON.
I APPRECIATED YOUR ROLE AS
INSTITUTE DIRECTOR AND SOMETHING
YOU HAVE AS A PRIORITY.
I THINK YOU CAN SEE IT IN THE
GRANTS AND SOME OF THE CONCEPT
CLEARANCES THAT WE'VE APPROVED
OVER THE YEARS.
THERE HAS BEEN AN INCREASED
AWARENESS OF SEX AND GENDER
DIFFERENCES BOTH IN THE INTEREST
OF THE COUNCIL AND IN THE GRANTS
FUNDED.
THIS IS IN NO SMALL PART DUE TO
YOUR ROLE AND I CAN'T GO THROUGH
ALL THE GRANTS THAT ARE GOING TO
BE FUNDED.
I SERIOUSLY READ ALL OF THEM AND
LOOK FOR INDICATIONS THAT SEX
DIFFERENCE HAS NOT BEEN
CONSIDERED APPROPRIATELY BY THE
EVALUATION OF THE STUDY
SECTIONS.
I HOPE SOMEONE ELSE WILL TAKE
THAT ROLE, MAYBE LAURA O'DELL.
I PASS THE TORCH TO YOU BECAUSE
I THINK IT'S INCREDIBLY
IMPORTANT NOW THAT WE HAVE BEEN
PAYING ATTENTION TO SEX AND
GENDER DIFFERENCES IT CONTINUES.
S -- ONCE YOU DISABROGATE THE
DATA THERE'S DIFFERENCES AND AS
YOU START DIGGING INTO HOW THE
DIFFERENT DRUGS OR BRAIN OR
LIVER ARE WORKING IT'S IMPORTANT
BOTH SEXES ARE ADEQUATELY
STUDIED SO BOTH CAN BE HELPED.
AND AS A NOTE TO MAKE SURE SEX
IS PART OF THE REPOSITORY SO
PEOPLE CAN LOOK AT IT EVEN IF
THE PRIMARY INVESTIGATORS
HAVEN'T DONE SO.
THANK YOU.
I'VE ENJOYED IT AND I GUESS I'LL
MISS COUNCIL MEETINGS.
I MISSING IN PERSON.
I WAS HOPING THIS WOULD BE AN IN
PERSON MEETING.
>>GIVEN THE WEATHER WE PROBABLY
COULD HAVE GOTTEN AWAY WITH IN
PERSON MEETING AND THIS IS THE
MILDEST WEATHER SINCE I STARTED
NIAAA.
ONE YEAR WE HAD SNOWMAGEDDON.
WE'LL MISS YOU, JILL AND WILL
TRY TO PASS THAT TORCH TO LAURA
AND SEE IF SHE CAN PASS IT TO
SOMEONE ELSE WHEN SHE LEAVES.
I THINK YOU STIMULATED STAFF TO
KEEP AN EYE ON THIS SO
ACCOMPLISH ACCOMPLISHED.
CONNIE.
>>IT'S BEEN A TRUE HONOR FOR ME
AS WELL.
AN HONOR AND PRIVILEGE.
IT'S BEEN A WONDERFUL
PROFESSIONAL EXPERIENCE FOR ME
THAT I HAD NOT ANTICIPATED QUITE
AS MUCH.
I GUESS WE'RE ALL SILOED AND
SAYING WE NEED TO HAVE MORE OF A
PERMEABLE ROLE SO PEOPLE WITH
DIFFERENT DISCIPLINES ARE
TALKING TO EACH OTHER AND
LEARNING FROM EACH OTHER AND
SEEING WHERE SYNERGIES CAN
HAPPEN AND OVER THE FOUR YEARS
THAT'S HAPP PED -- HAPPENED AND
KNOW LIVER DOCTORS NOW MORE THAN
BEFORE AND I'M GRATEFUL FOR THAT
EXPERIENCE.
AND BEYOND EXPANDING MY
KNOWLEDGE OF ALCOHOL BEYOND WHAT
THE ECONOMISTS TYPE PERSON
DOESN'T KNOW AND I HAD A LOT TO
LEARN, I DO APPRECIATE THE
OPPORTUNITY TO HAVE FOUND AREAS
OF SYNERGY AND TALK MORE ABOUT
ISSUES RELATED TO ACCESS, COST
AND QUALITY OF SERVICES AND HOW
THAT IMPACTS ACTUALLY GETTING
SERVICES PAID FOR, MANAGE D
ORGANIZED INTO THE SYSTEM.
IT'S AT THE END OF TAKING THE
WONDERFUL BASIC SCIENCE OF
DISCOVERIES MADE AND THE
CLINICAL STUDIES AND MAKING SURE
IT GETS IMPLEMENTED AND MOVED IN
THE REAL WORLD TO MAKE A
DIFFERENCE.
I WANT TO SAY THANK YOU TO
GEORGE FOR LEADING THE CHARGE IN
THIS THE WHOLE TIME I'VE BEEN
HERE AND ALSO OTHER PEOPLE WHO
HAVE BEEN INVOLVED AND STAFF
WITH HEALTH SERVICES RESEARCH,
TRISH POWELL, YOU CERTAINLY HAVE
BEEN A SUPPORTER AND DR. RAY
LINTON AND NOW LAURA.
AND I'D LIKE TO RECOGNIZE
RETIRED PEOPLE, ABE, HOW CAN
SOMEBODY NOT ASK ABE ABOUT
HEALTH SERVICES RESEARCH AND
SOMEONE WHO HAS BEEN LONG
RETIRED BUT HERE WHEN I FIRST
STARTED WAS BOB HUBENER.
THERE'S A LEGACY OF PEOPLE THAT
HAVE MADE A DIFFERENCE.
I WANT TO THANK ALL FOR ALL
YOU'RE DOING AND HOPING IT WILL
CONTINUE.
I CAN SAY TODAY'S MEETING WAS --
ALL THE MEETING ARE FABULOUS.
I LOVE COMING TO COUNCIL.
IT'S BEEN ONE OF THE HIGH POINTS
KNOWING THREE TIMES A YEAR
YOU'LL BE COMING HERE AND IT'S
AN EXAMPLE OF STELLAR
CONVERSATIONS THAT HAVE TAKEN
PLACE AND HAVE BEEN INFORMED.
IT'S BEEN A WONDERFUL
EXPERIENCE.
THANK YOU ALL AND THANK YOU,
GEORGE, FOR LEADING THE CHARGE
AND MAKING IT A HEALTHY
ENVIRONMENT FOR THAT TO HAPPEN.
>>THANK YOU, CONNIE.
WE'LL MISS YOU TOO.
I REALLY THINK -- I CALL IT
TRYING TO SCALE UP SOME THINGS
WE'VE BEEN DOING TO HELP PEOPLE.
I'VE EVEN RAISED THE IRISH WITH
THE HEAL INITIATIVE.
I KNOW MOST OF YOU PROBABLY
DON'T KNOW BUT I'VE BEEN SOMEHOW
ELECTED TO BE ON THE BOARD OF
THE HEAL INITIATIVE.
THAT'S HEALTHY END TO THE
ADDICTION CRISIS.
IF YOU KNOW ALL THE ACRONYMS
IT'S TIME TO RETIRE SO IT'S NOT
TIME FOR ME TO RETIRE THERE.
I THINK WE HAVE A CHALLENGE
THERE.
THE KEY WILL BE WORKING WITH
OTHER FEDERAL AGENCIES TO AFFECT
CHANGES AN THAT'S WHERE THE
MONEY IS WITH SAMHSA AND HRSA.
WE MAY BE TAPPING YOUR BRAIN
AGAIN, CONNIE ON SOME OF THESE
ISSUES.
THANKS AGAIN.
>>WOULD LOVE TO.
THANK YOU.
>>SCOTT.
WHAT WORDS OF WISDOM DO YOU HAVE
FOR US?
>>BEYOND WHAT CONSTANCE AND
JILL ALREADY MENTIONED, MY GOSH,
THAT WAS PERFECT.
AS THEY MENTIONED, I JUST WANT
TO ECHO MY GRATITUDE FOR BEING
CHOSEN TO BE PART OF THIS.
IT'S BEEN AN APLACING
EXPERIENCE.
-- AN AMAZING EXPERIENCE.
MEETING PEOPLE AND MAKING NEW
FRIENDS AND SEEING OLD FRIENDS,
I LIKE JILL, JOYAND ENJOYED THE
PERSON COUNCILS, IT WAS AN
AMAZING EXPERIENCE EARLY ON TO
REALLY NETWORK.
I STILL KEEP IN TOUCH WITH SOME
OF THOSE LIVER DOCS, CONNIE.
IT'S GREAT TO MAKE FRIENDS WITH
THEM.
I THINK ONE OF THE THINGS I
DIDN'T REALIZE BEFORE COMING ON
TO NIAAA COUNCIL IS THE BREADTH
OF YOUR PORTFOLIO.
MORE THAN OTHER CNS INSTITUTES
AND I'LL LEAVE IT THAT THE.
NIAAA'S STRENGTH IS IN
CONSIDERING ADDICTION AS A WHOLE
BODY DISEASE PARTLY BECAUSE OF
THE DISEASE ITSELF AND THE
OPENNESS TO THINK ABOUT
ALTERNATIVE STRATEGIES WAS
CERTAINLY APPARENT TO ME AS A
MEMBER OF THE COUNCIL HERE.
THE LASTING EFFECT NIAAA HAS HAD
ON ME IS I MOVED OVER TO THE
FIELD OF ALCOHOL ADDICTION
ACTIVELY AND I'LL BE ATTEND IN
SOME OF THE UPCOMING MEETINGS
NEXT SUMMER AND IT WILL BE GREAT
TO CONNECT AND SEE SOME OF YOU
ONCE AGAIN.
I'VE LEARNED SO MUCH FROM
EVERYBODY AND IT'S BEEN AN HONOR
AND PLEASURE TO EVERYBODY.
I'LL MISSING ON THE CALL EVERY
THREE MONTHS OR SO OR FOUR
MONTHS OR SO.
WITH THE POTENTIAL AGENDA I
HEARD FOR THE NEXT MAY MEETING
MAYBE I'LL ASK GEORGE IF I CAN
COME BACK AND COP A SQUAT DO
HEAR SOME OF THE DISCUSSIONS.
IN THE INTEREST OF TIME, IT'S
4:48, I'LL STOP BELABORING THIS
BUT AGAIN I'LL MISS YOU ALL.
IT'S BEEN A HOOT.
HOPEFULLY WE'LL CONNECT AGAIN IN
THE FUTURE AND THANKS AGAIN FOR
THE OPPORTUNITY.
>>WE'LL TAP ON YOU BECAUSE YOU
HAVE A UNIQUE CAPACITY TO TAP
ACROSS DISCIPLINES AND IT'S
SOMETHING WE VALUED IN YOUR
DISCUSSIONS WITH US OVER THE
YEARS.
ALL OF YOU REALLY HAVE UNIQUE
CONTRIBUTIONS AND HELPED US A
LOT.
I JUST WANT YOU TO REALIZE IT
WASN'T A ONE-WAY STREET BY ANY
MEANS.
WE HIRED YOU AS I SAID FOR A
REASON AND YOU LOOKED UP TO THE
REASONS AND GRATEFUL YOU WERE
WILLING TO DO THIS AND STUCK
WITH US AND SO FORTH.
ANY WAY, CONTINUE TO BE
AMBASSADORS EVERYBODY FOR NIAAA.
WE ARE THE LITTLE ENGINE THAT
COULD AND ALCOHOL UNHEALTHY
ALCOHOL USE I NOW ADOPTED THAT
WORD THIS WEEK, IS PERMEATING
OUR SOCIETY.
I DON'T KNOW WHETHER I CAN
RECAPITULATE IT BUT JOHN KELLY
WROTE AND WE FINALLY FOUND OUT
JOHN AND I COULD FIND WHERE HE
WROTE IT AND HE WROTE IT AND
COULDN'T FIND IT AND HOW ALCOHOL
IS BECOMING THE -- THE PATHOLOGY
WITH ALCOHOL IS BECOMING ENURED
IN OUR SOCIETY AND THE PATHOLOGY
DOCS WONDERED WHERE I KNEW THAT
WORD AND I SAID MY MOTHER WAS A
LINGUISTICS TEACHER.
I THINK WE HAVE A SPECIAL ROLE
IN SOCIETY AND HAVE THE LARGEST
FUNDER OF ALCOHOL RESEARCH IN
THE WORLD.
I THINK A LARGE PART OF THE
POPULATION HAS NEVER HEARD OF
NIH LET ALONE NIAAA.
CONTINUE TO BE AMBASSADORS.
IN YOUR WORLDS OF ACADEMIA A LOT
OF PEOPLE DON'T KNOW WE EXIST
AND THERE'S GOOD INFORMATION ON
OUR WEBSITE THANKS TO BRIDGET
AND HER TEAM AND IT IT'S BEEN
UPDATED AND IS TOP NOTCH FROM MY
PERSPECTIVE.
I URGE YOU ALL TO LOOK AT OUR
WEBSITE AND IF YOU FIND ERRORS
OR IN THE HPCR IF YOU FIND
ERRORS DOWN THE LINE, SOME
THINGS MAY GO OUT OF DATE,
PLEASE LET US KNOW.
THEY'RE ALL LIVING DOCUMENTS.
THEY CAN BE EDITED AND FIXED.
SO DOES ANYBODY ELSE HAVE
COMMENTS OR THOUGHTS OR
QUESTIONS?
RV?
>>I NEED TO MAKE AN
ANNOUNCEMENT OF THE NEXT MEETING
DATES.
IT WILL BE MAY 9.
THAT WILL BE FOLLOWED BY THE
MEETING ON MAY 10.
AND AS GEORGE MENTIONED WE'RE
PLANNING TO DO IT AS A HYBRID
MEETING AND HOPEFULLY MANY WILL
HAVE A CHANCE TO COME AND VISIT
US IN PERSON.
>>I INTEND TO BE THERE IN
PERSON AND I HOPE YOU ALL CAN
COME AND IT'S A BEAUTIFUL TIME
IN WASHINGTON.
USUALLY THE WEATHER IS GOOD SO
COME ON DOWN OR COME ON OUT OR
COME ON UP WHEREVER YOU ARE.
ALL RIGHT.
I'M GOING TO SIGN OFF.
TRISH, DO YOU WANT TO SAY FINAL
WORDS?
>>I WANT TO THANK EVERYBODY.
THE PRESENTATIONS WERE FANTASTIC
AND THE DISCUSSIONS WERE GREAT.
WE ALWAYS APPRECIATE THE INSIGHT
EVEN THOSE LEAVING US, PLEASE
CONTINUE TO GIVE US INSIGHT.
JUST BECAUSE YOU'RE NOT ON
COUNCIL, YOU CAN HELP US IN A
LOT OF DIFFERENT WAYS.
ONCE ON COUNCILS WE ALWAYS HAVE
YOUR E-MAILS.
>>AND VICKY AS EXECUTIVE
OFFICER, ANYTHING YOU WANT TO
SAY ABOUT THE STATE OF THE
INSTITUTE AND THE HIRING WE'RE
DOING OR TRYING?
>>NO, I THINK YOU COVERED
EVERYTHING, GEORGE.
IT WAS GREAT TO SEE EVERYONE
TODAY AND I AGREE WITH TREASISH
GREAT PRESENTATIONS AND
DISCUSSIONS.
>>WE'RE ALSO LOOKING FOR A
PROGRAM OFFICER.
YOU'RE NOT THE ONLY PEOPLE
LOOKING FOR PEOPLE TO DO THE
WORK.
WE ARE TOO.
AND THEN BRIDGET, DO YOU HAVE
ANYTHING YOU WANT TO SAY,
SCIENCE POLICY, PRESS OFFICE?
ANYTHING YOU WANT TO CONVEY TO
EVERYBODY BEFORE WE SIGN OFF?
>>NO, WE THANK YOU ALL.
GOOD TO SEE YOU AND AS GEORGE
MENTIONED IF YOU FIND ANYTHING
ON OUR WEBSITE, FEEL FREE TO LET
US KNOW.
WE'RE OPEN TO ALL YOUR INPUT.
THANKS.
>>AS THEY USED TO SAY IN THE
BRITISH NEWS IT'S TIME TO SAY
GOOD NIGHT SO GOOD NIGHT.