>>I WANT TO WELCOME EVERYONE
TO THE 141st MEETING OF THE
NATIONAL ADVISORY COUNCIL ON
DRUG ABUSE.
THE GOVERNMENT IN THE SUNSHINE
ACT AND FEDERAL ADVISORY
COMMITTEE ACT REQUIRE AS MANY
ADVISORY COMMITTEE MEETINGS AS
POSSIBLE BE OPEN TO THE PUBLIC.
THIS INCLUDES MEETINGS OF THE
NATIONAL ADVISORY COUNCIL ON
DRUG ABUSE.
TODAY'S MEETING IS OPEN TO THE
PUBLIC AND IS BEING VIDEOCAST
AND RECORDED.
MINUTES OF THE MEETING WILL BE
AVAILABLE ON THE NIDA HOME PAGE
AND RECORDINGS OF THE OPEN
COUNCIL MEETING ARE POSTED ON
THE NIH VIDEOCAST SITE.
MEMBERS OF THE PUBLIC WHO WISH
TO SUPPRESS VIEWS MAY WE DR.
SUSAN WEISS, EXECUTIVE
SECRETARY, WITHIN 10 DAYS OF THE
MEETING.
ANY WRITTEN STATEMENTS BY
MEMBERS OF THE PUBLIC WILL
RECEIVE CAREFUL CONSIDERATION.
SO, NORA I KNOW WOULD WANT TO
ACKNOWLEDGE DEPARTING COUNCIL
MEMBERS WHO HAVE DONE A
TREMENDOUS JOB IN CONTRIBUTIONS
TO THINKING, TO OUR POLICIES,
AND TO OUR PRIORITIES.
GAIL D'ONOFRIO, WE SAW SOME OF
THE FRUITS OF YOUR COMMENTS LAST
TIME.
CARLOS DEL RIO, WE REALLY
APPRECIATE YOUR INVOLVEMENT,
INCLUDING ON THE NIH ADDICTION
RESEARCH COUNCIL, NIH AIDS
OFFICE OF AIDS RESEARCH COUNCIL,
WHICH WAS EXTREMELY HELPFUL.
LAKSHMI DEVI, WE APPRECIATE YOUR
INPUT AND CHRISTIAN HIDERIGHTER,
HE WAS REPRESENTING PHARMA, AND
THAT'S SOMETHING IMPORTANT AS WE
HAVE A LARGE MEDICATIONS
DEVELOPMENT PORTFOLIO AS YOU
HEARD ABOUT EARLIER.
I WILL ALSO WELCOME OUR NEW
COUNCIL MEMBER, AMIT ETKIN,
FOUNDER AND CEO OF ALTO
NEUROSCIENCE, A CLINICAL STAGE
PHARMACEUTICAL COMPANY, TO
IMPROVE THE LIVES OF PEOPLE WITH
MENTAL HEALTH CONDITIONS.
AMIT TRAINING AS A PSYCHIATRIST
AND NEUROSCIENTIST, AS A
PROFESSOR AT STANFORD STUDIED
NEUROBASIS OF EMOTIONAL
DISORDERS AND THEIR TREATMENTS.
THROUGHOUT HIS CAREER HE'S BEEN
RECOGNIZED WITH NUMEROUS AWARDS
INCLUDING THE NIH DIRECTOR'S
PIONEER AWARD, AND RECEIVED HIS
MD/PHD FROM COLUMBIA UNIVERSITY,
COMPLETED A PSYCHIATRIC
RESIDENCY AND POSTDOC AT
STANFORD UNIVERSITY.
WELCOME, WE'RE VERY HAPPY TO
HAVE YOU ON BOARD.
I'M LOOKING TO SEE IF HE'S
VISIBLE.
AH, THERE YOU ARE.
I KEEP MISSING YOU.
SORRY ABOUT THAT.
WELCOME.
WE'RE VERY GLAD TO HAVING YOU ON
BOARD.
>> LOOKING FORWARD TO
CONTRIBUTING.
>> GREAT.
I'M GOING TO ASK FOR ANY
COMMENTS OR CORRECTIONS TO THE
MINUTES FROM THE FEBRUARY 22
MEETING, A COPY OF THE MINUTES
WAS IN THE ELECTRONIC COUNCIL
BOOKS.
SO ARE THERE ANY COMMENTS?
AND IF NOT, I'M GOING TO ASK FOR
A MOTION FOR APPROVAL OF THE
MINUTES.
AND SECOND.
ALL APPROVE?
ANY DISAPPROVE?
MOTION IS CARRIED.
OKAY.
THE FUTURE COUNCIL DATES ARE
SEPTEMBER 13, 2022, FOR THE NEXT
NIDA ADVISORY COUNCIL.
WE ARE STILL THINKING ABOUT
WHETHER OR NOT THAT WILL BE DONE
ALL VIRTUAL OR HYBRID, AND THIS
IS SOMETHING WE'LL FOLLOW UP
WITH YOU ON AFTER THIS MEETING.
FEBRUARY 8, 2023.
AND THEN THE NEXT NIDA AND CRAN
COUNCIL WILL BE MAY 9 AND 10,
2023.
I WANT TO REMIND EVERYBODY
TOMORROW IS THE CRAN COUNCIL
WITH THE NATIONAL INSTITUTE ON
DRUG ABUSE AND ALCOHOLISM AS
WELL AS PART OF THE NCI,
NATIONAL CANCER INSTITUTE
COUNCIL, WITH TOBACCO AND
POPULATION CONTROL, WE'LL GET AN
UPDATE ON OUR ABCD STUDY
TOMORROW.
WHAT I WANTED TO TALK ABOUT WAS
THE FUTURE OF NIDA METHOD TO
EXTEND WE SEARCH IN TIME, OR
MERIT AWARDS.
AND THIS IS SOMETHING THAT WE'VE
BEEN DISCUSSING INTERNALLY, WE
WANTED TO BRING IT TO COUNCIL TO
GET SOME INPUT AS TO HOW WE
SHOULD THINK ABOUT IT GOING
FORWARD.
SO, THE PURPOSE OF THE MERIT
AWARD IS TO GIVE IT TO
INVESTIGATORS WHO DEMONSTRATED
SUPERIOR COMPETENCY, OUTSTANDING
PRODUCTIVITY DURING THEIR PRIOR
RESEARCH, AND WITH OUR
EXPECTATION THAT LEVEL OF
PRODUCTIVITY AND EXCELLENCE IS
GOING TO CONTINUE.
IT ALLOWS THEM TO HAVE AN
EXTENSION IN TIME OF THEIR GRANT
AND THEREFORE IT WOULD MOVE SOME
ADMINISTRATIVE BURDENS
ASSOCIATED WITH PREPARATION AND
SUBMISSION OF THE CONTINUATION
RESEARCH APPLICATION.
IT'S NOT AN AWARD THAT PEOPLE
CAN APPLY FOR.
IT'S SOMETHING THAT INSTITUTE
STAFF NOMINATE CANDIDATES FOR.
THESE NOMINATIONS ARE PRESENTED
TO COUNCIL FOR CONSIDERATION,
AND APPROVAL, APPROVAL VOTE, AND
FINAL SELECTIONS ARE MADE BY
INSTITUTE DIRECTOR.
SO THE REQUIREMENTS FOR NIDA ARE
THAT THE APPLICANT PREVIOUSLY
SERVED AS P.I., RECORD OF
SCIENTIFIC ACHIEVEMENTS AND
PUBLICATIONS, EXISTING R01
THAT'S SCORED IN THE 5th
PERCENTILE OR BETTER IN ONE OF
THE PAST TWO REVIEW CYCLES.
A TIME COMMITMENT OF AT LEAST
15% IS REQUIRED BY THE P.I. OF
THE BRANCH.
SO, OTHER INSTITUTES ARE
THINKING ABOUT THE FUTURE OF
MERIT AWARDS, SOME HAVE
DISCONTINUED AWARDING ANY OF
THESE SO THAT INCLUDES NHLBI,
NIGMS, NEI, NIAMS.
SOME OTHER INSTITUTES HAVE
SIMILAR BUT SLIGHTLY DIFFERENT
CRITERIA FOR WHO IS AWARDED, WHO
RECEIVES A MERIT AWARD, BUT MOST
OF THE INSTITUTES ARE GIVING
THESE TO FAIRLY ESTABLISHED
P.I.s, YOU CAN SEE FOR NIAA
NIAAA IT HAS TO BE AT THE
PROFESSOR LEVEL.
NIMH ALSO REQUIRES SOMEBODY THAT
HAS EVIDENCE OF A LONG RECORD OF
INDEPENDENT RESEARCH SUPPORT,
AND HIGH END PUBLICATION, HIGH
PRIORITY JOURNAL, AT LEAST ONE
PREVIOUS R01 PROJECT PERIOD OF
SUPPORT FROM NIH.
NINDS HAS THE JAVITS AWARD,
SEVEN YEARS.
OUR MERIT AWARDS ALLOW FOR
SUPPORT UP TO TEN YEARS,
DEPENDING WHEN IT'S GIVEN.
THIS IS A SEVEN-YEAR AWARD AND
CONSIDER MID-CAREER P.I.s BUT
FOR THE MOST PART SENIOR LEVEL
P.I.s.
AND NIBIB, IMAGING AND
BIOENGINEERING USES THE MERIT
AWARD BUT RARELY, FOR ESTABLISH
INVESTIGATORS.
NIAID CONTINUES TO USE IT, NIA
IS ALSO BRINGING THIS QUESTION
TO THEIR COUNCIL SO THEY ARE
ALSO SEEKING INPUT ON HOW TO GO
FORWARD.
NCI, WHAT I WANT TO HIGHLIGHT
HERE, THEY HAVE A MERIT AWARD
THAT PROVIDES LONGER-TERM GRANT
SUPPORT, SEVEN YEARS, GEARED TO
EARLY STAGE INVESTIGATORS,
ORIGINAL AWARD FOR FIVE YEARS,
ADMINISTRATIVE REVIEW, AND THEY
CAN GET TWO MORE YEARS OF
SUPPORT.
SO THIS JUST SHOWS YOU THE
NUMBER AND THE GENDER OF THE
AWARDEES FROM NIDA, FROM 2002 TO
2021.
WE DON'T GIVE A HUGE NUMBER OF
THESE AWARDS EACH YEAR, AS YOU
CAN SEE.
AND FOR THE MOST PART THEY HAVE
BEEN TO MALES.
AND THIS IS A BREAKDOWN BY THE
DIVISIONS, NIDA DIVISIONS.
SO THE DIVISION OF NEUROSCIENCE
AND BEHAVIOR HAS GOTTEN MOST OF
THESE AWARDS, ESPECIALLY IN
RECENT YEARS.
THE DIVISION OF EPIDEMIOLOGY
SERVICES AND PREVENTION RESEARCH
HAS GOTTEN A PORTION OF THESE
AND OUR DIVISION OF THERAPEUTICS
AND MEDICAL CONSEQUENCES HAVE
GOTTEN FEWER OF THEM.
THEY HAVE TENDED TO GO TO BASIC
NEUROSCIENTISTS PREFERENTIALLY.
THIS SLIDE IS SHOWING A METRIC
THAT NIH DEVELOPED TO TRY AND
LOOK AT THE INFLUENCE OF
PUBLICATIONS, IT'S CALLED THE
RCR, RELATIVE CITATION RATIO,
BENCHMARKING COMPARED TO OTHERS
IN THE SAME FIELD AND
CORRESPONDING YEAR OF
PUBLICATION.
SO, ONE IS FOR TYPICAL NIH
PAPER, AND SPECIFIC YEAR OF
PUBLICATION, AND WHAT I'M
SHOWING HERE IS A FAIRLY GROSS
INDICATION, IT'S THE MEAN RCR
FOR EACH OF THE PEOPLE WHO
RECEIVED A MERIT AWARD FROM NIDA
BY YEAR.
YOU CAN SEE IN GENERAL, THE RCR
IS -- ONE IS, AS I SAID, THE
BENCHMARK, A TYPICAL PAPER.
YOU CAN SEE FOR THE MOST PART
THAT THE AWARDEES HAVE MUCH
HIGHER RCRs OVERALL THAN THE
ONE WHICH IS THE AVERAGE.
SO, I THINK THAT -- I MEAN, IF
YOU -- WE DIDN'T SHOW YOU THE
LIST OF MERIT AWARDEES.
THEY ARE ALL VERY ESTEEMED
INVESTIGATORS, SEVERAL ON OUR
COUNCIL NOW, SEVERAL ON OUR
COUNCIL BEFORE.
I DON'T THINK THERE'S ANY
QUESTION THE PEOPLE WHO RECEIVED
MERIT AWARDS DESERVED THEIR
AWARDS.
THEY REALLY HAVE BEEN VERY HIGH
IMPACT SCIENTISTS.
THE QUESTION THAT WE'RE COMING
TO RIGHT NOW IS DO WE CONTINUE
TO RECOGNIZE SENIOR HIGHLY
PRODUCTIVE INVESTIGATORS WHO WE
KNOW ARE UNLIKELY TO HAVE TO GO
THROUGH PERIODS WHEN THEY ARE
NOT GOING TO BE SUPPORTED
THROUGH THEIR GRANTS AND WHO WE
ALSO KNOW OFTEN RECEIVE MANY
OTHER AWARDS BESIDES THIS MERIT
AWARD, SO WHILE IT'S CERTAINLY
CONSIDERED TO BE A RECOGNITION
OF THEIR MAJOR CONTRIBUTIONS, IT
MAY NOT BE PARTICULARLY
NECESSARY IN TERMS OF THEIR
OVERALL CAREER PATH AND
INFLUENCE.
WE CAN STOP DOING MERIT AWARDS
ALTOGETHER.
WE COULD REVISE THE CRITERIA FOR
MERIT AWARDS TO FOCUS MORE ON
EARLY-STAGE INVESTIGATORS.
AND THE OTHER THING I WOULD
MENTION IS THAT OUR DIVERSITY
FOR THESE AWARDS IS VIRTUALLY
NON-EXISTENT.
THERE ARE FOUR PEOPLE WHO WERE
ASIAN, WHICH NIH DOES NOT REALLY
CONSIDER TO BE AN
UNDERREPRESENTED MINORITY IN
SCIENCE.
THE REST ARE ALL WHITE
NON-HISPANIC.
SO GIVEN THIS INFORMATION, AS I
SAID, AGAIN, WE RECOGNIZE THE
PEOPLE WE'VE GIVEN THE MERIT
AWARDS TO ARE VERY MUCH
DESERVING OF IT BUT WE'RE TRYING
TO FIGURE OUT WHAT TO DO GOING
FORWARD AND DECIDED WE WANTED TO
BRING IT TO COUNCIL AND GET YOUR
FEEDBACK ON THIS.
I DON'T KNOW IF NORA HAS ARRIVED
YET.
>> I'M HERE, I'M HERE.
>> OKAY.
WE CAN COME BACK TO THE
DISCUSSION OF THIS AFTER YOU DO
YOUR PRESENTATION, NORA.
>> IT MAY BE PERHAPS BEST TO DO
IT NOW BECAUSE YOU HAVE JUST
PRESENTED.
>> THAT'S FINE WITH ME.
I'M JUST WORRIED ABOUT THE
TIMING BECAUSE I KNOW MIKE LAUER
IS COMING AT 2:45 AND WE DON'T
HAVE A LOT OF FLEXIBILITY BUT
I'M HAPPY TO LEAD THE DISCUSSION
NOW IF YOU WANT TO DO THAT.
>> YEAH, LET'S DO THAT.
YEAH, AND I HAVE THE HEARING
ALSO, I HAVE TO STEP OUT.
YEAH, LET'S DO THE DISCUSSION
NOW.
>> OKAY.
SO, CHARLES?
>> I CAN TELL YOU AS A
RECIPIENT, OTHERS IN THE ROOM
ARE ALSO RECIPIENTS, IT WAS
VERY, VERY IMPACTFUL.
NOT IN THE SENSE IT INCREASED
TOTAL AMOUNT OF GRANT DOLLARS
BECAUSE IT DIDN'T DO THAT.
WHAT IT DID DO IS ELEVATE MY
APPRECIATION WITHIN MY
INSTITUTION AT THE UNIVERSITY OF
WASHINGTON, THERE ARE A LOT OF
WELL-FUNDED INVESTIGATORS, A LOT
EVER US GET A LOT OF AWARDS, BUT
BY RECOGNITION BY NIDA OF MY
EFFORTS, MY STANDING WITHIN THE
PECKING ORDER FOR ALLOCATION OF
RESOURCE US WAS SUBSTANTIALLY
INCREASED AND GAVE ME THE
POSITION TO GO TO DCM TO LOBBY
FOR UPGRADED ANIMAL FACILITIES.
I HAD STANDING TO DO THAT, TO
GET NEW RESOURCES ALLOCATED TO
MY YOUNGER INVESTIGATORS AND PUT
ME IN A GOOD POSITION TO
ORGANIZE OTHER PROGRAM PROJECT
GRANTS IN WAYS THAT HAD IMPACT
NOT ONLY ON MY OWN RESEARCH BUT
BECAUSE I HAD A LEADERSHIP ROLE
RECOGNIZED MY NIDA MY COLLEAGUES
FLOCKED TO ME AND WE CREATED A
CENTER.
I CAN SEE, IT'S PROBABLY SIMILAR
FOR OTHERS, DIDN'T GIVE ME MORE
MONEY BUT GAVE ME MORE PEDESTAL
TO LEVERAGE A HIGHER VISIBILITY
LEADERSHIP ROLE AT MY
INSTITUTION.
>> I THINK THERE ARE TWO MORE
RAISED HANDS.
>> MELISSA?
>> SUSAN, MY COMMENT IS I FIND
THE LACK OF -- OR PERPETUATION
OF INEQUITY ABYSMAL, THE FACT
THERE'S MOSTLY WHITE MALES
GETTING THE AWARDS, WHAT'S WRONG
WITH ACADEMIA AND OUR SYSTEM IN
GENERAL AND WOULD URGE US TO
CONSIDER A COMBINATION OF THINGS
THAT COULD BE NOT JUST ABOUT
DIVERSITY BUT ALSO ABOUT
PROMOTING INVESTIGATORS WHO ARE
ADVANCING THE SCIENCE OF HEALTH
EQUALITY, HEALTH EQUITY
ACTUALLY, SORRY.
AND THAT COULD BE PREPPING
TOPICS.
I THINK THE MOST SIGNIFICANT
PUBLIC HEALTH ISSUE ACROSS THE
BOARD, WHETHER DRUG USE OR ANY
OF INSTITUTES AT NIH, IS THE
FACT THAT WE HAVE THESE
HEALTH -- UNEQUAL HEALTH
OUTCOMES ROOTED IN RACISM SO
THAT POINT ON THE SLIDE ABOUT
REALLY EMPHASIZING REWARDING
THOSE PEOPLE WHO ARE TRYING TO
DO IT DIFFERENTLY, I WANT TO PUT
MY PUBLIC SUPPORT OUT THERE FOR
IT.
>> THANK YOU.
TRAVIS?
>> YEAH, HI.
I APOLOGIZE THAT I'M SICK, A
LITTLE BIT OUT OF VOICE.
BUT I WANT TO SECOND WHAT
MELISSA WAS SECOND.
MY DAY JOB IS I'M AN ETHICIST,
TEACH A LOT OF JUSTICE AND
EQUITY SORTS OF CONSIDERATIONS,
AND THE BASIC STRUCTURE OF THE
AWARD, WHICH IS NOT TO SOUND
DEMEANING BUT IT'S A RICH GET
RICHER SORT OF THING.
LIKE IF YOU'VE DONE REALLY WELL,
YOU DO A LITTLE BIT BETTER.
AND WHEN YOU HAVE THAT SORT OF
STRUCTURE, IT DOES INCENTIVIZE
PERPETUATING STATUS QUO,
INCENTIVIZING PERPETUATING.
SO I DON'T KNOW, THIS IS NOT TO
SAY I HAVE A STRONG VIEW YOU
BRING TO COUNCIL, HERE IS A
QUESTION, WE COULD DO IT
DIFFERENT.
I ACTUALLY DON'T KNOW WHAT MY
VIEW IS BECAUSE IT'S THE FIRST
I'VE HEARD OF IT, BUT MY JUSTICE
SPIDEY-SENSE GOES OFF BECAUSE OF
THE STRUCTURE OF THE AWARD AND
THE OUTCOMES THAT WERE NOTED
WHEN IT COMES TO DIVERSITY.
SO, I'M SECONDING SOME OF WHAT
MELISSA SAID AND I'M GLAD YOU'RE
RAISING THE ISSUE AND IT SEEMS
WORTH TALKING ABOUT.
THANKS.
>> RAJITA?
>> THANK YOU FOR RAISING THE
ISSUE.
I HAD A COUPLE QUESTIONS.
ONE WAS OF COURSE IN ADDITION TO
THE DIVERSITY, WHICH IS REALLY
QUITE APPALLING BUT NOT QUITE
TYPICAL, THE WOMEN'S ISSUE, LESS
WOMEN, AND THEN ALSO THE
STARKNESS OF VERY LOW NUMBERS OF
CLINICAL AND CLINICAL SCIENTISTS
BEING -- RECEIVING THIS IS THE
OTHER ASPECT OF IT, GIVEN THAT
AT THE END OF THE DAY WE WANT TO
REALLY HIGHLIGHT THOSE WHO ARE
CHARTING THE PATH TOWARDS
PREVENTION AND TREATMENT AND
UNDERSTANDING THE CAUSES OF
ADDICTION IN HUMANS.
AND SO I JUST WANTED -- I KNOW
HISTORICALLY THERE WAS A VERY
BIG BIAS TOWARDS BASIC SCIENCE,
SCIENTIFIC KNOWLEDGE, BUT
MAYBE --ED MADE ME THINK ABOUT
HOW DOES SOMEBODY GET NOMINATED,
IS IT AUTOMATIC BASED ON THE
SCORE OF THE GRANT, THE
PARTICULAR GRANT?
OR THEN AFTER THAT, THERE'S A
PROCESS OF NOMINATION THAT ALSO
HAS TO HAPPEN?
AND HOW DOES THAT -- YOU KNOW,
EVERY POINT AT WHICH ONE HAS
JUDGMENT COMING IN THERE'S GOING
TO IMPLICIT BIASES AND THINGS
THAT COME IN SO IT WOULD BE GOOD
TO BREAK THAT DOWN AS WELL.
>> SO THERE ARE SOME REASONS
BESIDES THE BIAS TOWARDS BASIC
SCIENCE, ACTUALLY BONNIE, I
DON'T KNOW IF SHE'S ON THIS, SHE
DID AN ANALYSIS LOOKING AT THE
NUMBERS OF APPLICATIONS THAT
WOULD QUALIFY, OR THE
DISTRIBUTION OF SCORES FOR
APPLICATIONS FROM THE DIFFERENT
DIVISIONS.
AND BOTH DNB AND DESPER HAVE A
SIMILAR DISTRIBUTION BUT DNB HAS
MORE.
IT HAS TO BE AN R01, IT CAN'T BE
AN A-1, HAS TO BE AN ORIGINAL
R01, IN THIS CASE BECAUSE PEOPLE
CAN SUBMIT MULTIPLE TIMES NEW
GRANTS.
THERE'S SOME BIAS JUST BUILT IN
BECAUSE OF THE WAY IN WHICH WE
FUND CLINICAL RESEARCH OR FUND
SERVICES RESEARCH, SO THAT
PEOPLE ARE NOT GOING TO BE
ELIGIBLE.
SO-- BUT THAT DOESN'T MEAN THERE
ALSO ISN'T A NEED FOR THAT OR A
NEED FOR SOME WAY TO RECOGNIZE
CLINICAL OR TRANSLATIONAL
RESEARCH IN PARTICULAR, BUT SOME
OF THAT IS JUST THE WAY IN WHICH
THE MERIT HAS BEEN STRUCTURED,
WHICH IS THIS REQUIREMENT THAT
IT BE AN R01 AND IT BE IN THE 5
PERCENTILE.
>> I THINK THIS IS USEFUL IF WE
STICK WITH FOLKS WHO ARE SENIOR,
IMAGINE THAT OUR BASIC SCIENCE
FOLKS WILL GET THE ADVANTAGE OF
PROLIFERATING AT THE
INSTITUTIONS AND GROWING IT, BUT
REALLY WE ALSO WANT OUR CLINICAL
SCIENTISTS TO BE DOING THAT AND
GETTING RESOURCES.
OFTENTIMES OUR INSTITUTIONS TEND
TO BE BIASED TOWARDS BASIC
SCIENCE.
I HAVE NO PROBLEM, I'M JUST
SAYING WE NEED TO MAKE IT MORE
EQUITABLE TO REALLY HIGHLIGHT,
THE DESPERATE NEED THAT
ADDICTION NEEDS IN TERMS OF
ATTENTION AT THE INSTITUTIONAL
LEVEL, COMMUNITY LEVEL, AT THE
LEVEL OF TRANSLATING FINDINGS
INTO HUMANS, AND THIS COULD
BE -- THIS IS PROBABLY ONE OF
THE VERY FEW WAYS IN WHICH IN
ADDITION TO NIH GRANTS THAT NIH
OR FEDERAL GOVERNMENT'S
RECOGNITION OF THE WORK OF
SCIENTISTS.
AND SO I THINK SOME
CONSIDERATION, MAYBE THINKING
HOW WE'RE GOING TO DO THAT PAST
R01s, AGAIN CONTRIBUTIONS,
MAYBE LOOKING AT IMPACT FACTOR
OR IMPACT OF THE SCIENCE PAST
RCRs, SOME OTHER WAYS OF
COMING UP WITH METRICS MIGHT
REALLY BROADEN THE CAUSE OF
ADDICTION, ALSO THE GOALS THAT
NIDA HAS AND THE NIH.
>> YEAH, JUST ONE OTHER
CLARIFICATION FROM BONNIE, THE
DNB DOES SUPPORT SOME CLINICAL
RESEARCH AND THEY HAVEN'T LOOKED
AT THE DISTRIBUTION IN TERMS OF
AWARDS BETWEEN CLINICAL RESEARCH
THEY SUPPORT AND BASIC.
YOUR POINT IS WELL TAKEN..
>> I WAS ONE OF THE FOUR ASIAN
WOMEN.
LIKE CHARLIE, IT DID ENHANCE MY
STANDING WITHIN THE INSTITUTION
AS WELL AS COLLEAGUES.
HAVING SAID THAT, I DOP WANT TO
GIVE A SHOUT OUT TO YOU GUYS FOR
CONSIDERING EARLY-STAGE
INVESTIGATORS AS POTENTIAL
RECIPIENTS.
MY CONCERN IS HOW ARE THE
CRITERIA THAT ARE GOING TO BE
USED FOR SELECTING THEM?
WE HAVE TO BE MINDFUL OF THAT.
WITH THAT, TO GIVE CONSIDERATION
OF INCLUDING MID-CAREER AND
EARLY-STAGE INVESTIGATORS IN THE
MERIT AWARD RECIPIENT PROCESS.
>> DID YOU WANT TO SAY
SOMETHING, NORA.
>> NO.
>> AM I UP NOW?
>> YES, PLEASE.
>> YES.
>> HELLO.
I APOLOGIZE FOR NOT BEING ON
CAMERA.
UNFORTUNATELY, I TESTED POSITIVE
SO YOU DON'T WANT TO SEE ME.
BUT I DIDN'T WANT TO MISS THIS
MEETING.
I LOVED THE CONVERSATION THAT IS
GOING ON.
I LOVED IT.
WHAT A COUPLE COLLEAGUES SAID,
TO HAVE GOTTEN THIS AWARD, HOW
IT'S HELPED TO TAKE THEM A
LITTLE BIT HIGHER IN THEIR
RESPECTIVE AREA, GETTING
ADDITIONAL FUNDS.
MY QUESTION IS, AS I THINK THE
QUESTION WAS PUT OUT THERE BY
SEVERAL, IS IS THIS MORE A
PROCEDURAL PROCESS AND CRITERIA,
BECAUSE OBVIOUSLY THERE SHOULD
BE MORE UNDERREPRESENTED
COMMUNITY, GETTING THIS AWARD,
OR INDIVIDUALS FROM THERE, AND
I'M WONDERING HOW ARE WE
APPROACHING THAT BECAUSE WE
AREN'T DOING ANYTHING ON THE
FRONT END, OF COURSE THERE'S NOT
GOING TO BE ANY CHANGE ON THE
BACK END.
SO I'M WONDERING WHAT CAN WE OR
ARE THERE IDEAS THAT WE CAN COME
UP AS TO HOW WE CAN ATTRACT MORE
INDIVIDUALS OF DIVERSITY, NUMBER
ONE, BE IN A CATEGORY TO GET
THIS AWARD.
AND THEN, NUMBER TWO, IF SO, HOW
DO WE ACTUALLY DO THAT?
I DON'T KNOW ALL THE PROCESSES
THAT YOU ENGAGE IN UP TO THIS
POINT, BUT I'M JUST WONDERING
BECAUSE THERE ARE LOTS OF PEOPLE
OUT THERE DOING SO MUCH GREAT
WORK, PARTICULARLY IN THE AREA
OF BEHAVIORAL HEALTH AND
ADDICTION.
AND THERE ARE LOTS OF PEOPLE
FROM DIVERSE COMMUNITIES DOING
THIS WORK AND STUDIES, SO I'M
WONDERING WHAT THAT PROCESS IS
AND HOW CAN WE IMPACT IT A
LITTLE BIT MORE.
>> AGAIN, WE COULD CERTAINLY
MODIFY THE CRITERIA BUT IN
GENERAL THEY HAVE REQUIRED
PEOPLE TO SCORE IN THE 5
PERCENTILE OR BETTER, BUT WE'VE
ALSO FOCUSED A LOT ON THE
OVERALL RECORD OF
ACCOMPLISHMENTS AND
CONTRIBUTION, AND I THINK THIS
IS CERTAINLY WHERE WE COULD BE
STARTING TO CHANGE WHAT OUR
CRITERIA ARE.
WE COULD ALSO ADD IN A FOCUS ON
PARTICULAR AREAS OF SCIENCE, AND
I THINK IF WE WANT TO INCREASE
DIVERSITY, THEN WE ALSO DO NEED
TO BE STARTING WITH YOUNGER
INVESTIGATORS BECAUSE WE KNOW
THAT A LOT OF SENIOR LEVEL
INVESTIGATORS, YOU KNOW, AS A
RESULT OF MANY, MANY, MANY YEARS
ARE NOT FROM DIVERSE
BACKGROUNDS.
I THINK ALL OF THESE ARE FAIR
QUESTIONS, AND REALLY THIS IS
WHY WE'RE BRINGING IT TO YOU SO
WE COULD GO BACK AND DISCUSS IT
MORE AND FIGURE OUT WHERE WE
WANT TO GO WITH THIS.
>> HAS THE IDEA OF MAYBE A FOCUS
GROUP IN THIS AREA COME UP?
>> NO, BUT YOU'RE BRINGING IT UP
AND THAT'S WHAT SUSAN IS SAYING,
THE EXACTLY THE THINGS THAT
COULD HELP US, COME UP WITH
RECOMMENDATIONS BECAUSE THERE'S
FINITE RESOURCES, SO IT MEANS
WHENEVER WE EXTENDS HAS TO BE
WEIGHED AGAINST WHAT WE'RE NOT
GOING TO BE FUNDING.
AND IT'S NOT THAT SIMPLE AND
STRAIGHTFORWARD.
ABSOLUTELY, YES, THAT'S AN
ACTION ITEM THAT WE'RE GETTING
FROM ALL OF YOU.
>> THANK YOU.
>> I WAS GOING TO SAY, WE HAVE
TWO MORE QUESTIONS, MAYBE IF
THEY COULD BE QUICK SO NORA CAN
HAVE TIME FOR HER PRESENTATION
AND A LITTLE BIT OF QUESTIONS.
DR. ETKIN?
>> YES, I WON'T REPEAT WHAT'S
BEEN SAID, EXCELLENT POINTS, BUT
I ADVOCATE FOR POTENTIALLY
INCREASING THE PROGRAM.
I THINK CERTAINLY ACADEMIC
RESEARCH IS SO UNDERFUNDED,
HAVING BANDWIDTH, YOU KNOW, AND
SOME DISCRETION HOW TO SPEND
RESOURCES CAN GO A LONG WAY, IF
DIRECTED IN EXACTLY THE WAY
WE'VE BEEN TALKING TO CERTAIN
UNDERSERVED AREAS, BETTER
REPRESENTATION AND SO FORTH
THROUGHOUT.
BUT WHAT I MOSTLY FIND LACKING
IS METRIC OF SUCCESS.
I KNOW HIGH-RISK, HIGH-REWARD
PROGRAMS HAVE DONE A LOT OF
EVALUATION OF, YOU KNOW, ARE
THESE IMPACTFUL, HOW DOES IT
COMPARE WITH HOWARD HUGHES, IT
WOULD BE GREAT TO SET METRICS
BECAUSE IT MAY SUPPORT MORE
FUNDING RATHER THAN LESS DOWN
THAT MECHANISM.
AND HAVE CLEAR DATA TO SUPPORT
IT.
>> I THINK THAT ANDREW HAS A
RAISED HAND.
>> IN ADDITION TO INCREASING THE
FUNDING OF DIVERSE CANDIDATES,
NOT FOCUSING ON FOLKS THAT HAVE
ALREADY SUCCEEDED IN THEIR
CAREERS IS EARLIER THE FOLKS
EARLIER IN THEIR CAREERS DO GET
THIS AWARD OR SOME EVOLUTION OF
IT, TRANSLATING SOME EXISTING
SUPPORT MECHANISMS THAT NIDA HAS
PROVIDED IN THE FORM OF MENTOR
SHIP, PEER COACHING, TO ENSURE
EARLIER AND MID-CAREER FOLKS CAN
ACCELERATE THEIR PATH TO SENIOR
POSITIONS AND POSITIONS OF
INFLUENCE, I THINK THAT WOULD BE
REALLY USEFUL.
I ASSUME IT WOULD BE A LOT MORE
ADMINISTRATIVE WORK TO GET RID
OF THIS PROGRAM AND START A NEW
PROGRAM.
AND IF THAT ASSUMPTION IS
CORRECT, KEEP THE PROGRAM,
MODIFY PARAMETERS AND MAINTAIN
BUDGETING.
ONCE THE DOLLARS AND PROCESSES
ARE ALLOCATED, IT MAY BE A LOT
MORE WORK TO SCRAP IT AND START
FROM SCRATCH.
THANK YOU.
>> IS THAT YOUR HAND RAISED FROM
THE PAST, OR IS THAT A NEW ONE?
>> I'D LIKE TO CHANCE TO
RESPOND TO MELISSA.
IF THE AWARDS GO TO OLD WHITE
GUYS LIKE ME WE DON'T GET
INSTITUTIONAL CHANGE.
IN RESPONSE, IT MAY NOT BE FAIR
TO US OLD WHITE GUYS TO SAY
WE'RE NOT ALSO AGENTS OF CHANGE.
FOR EXAMPLEN MY LEADERSHIP
POSITION WHICH I SPOKE OF A
MOMENT AGO I'M FAIRLY COMMITTED
TO MENTORING JUNIOR
INVESTIGATORS, STUDENTS.
A SUMMER PROGRAM BRINGS IN
UNDERGRADUATES, NOT NORMALLY
INVOLVED IN STEM, INVOLVED IN
MENTORING POSTDOCS AND GRADUATE
STUDENTS.
IF YOU WANT TO LOOK MORE
BROADLY, NOT JUST DEMOGRAPHICS
OF RECIPIENTS BUT IMPACT OF WHAT
RECIPIENTS ARE DOING, YOU MAY
WANT TO LOOK MORE CLOSELY AS HOW
WE CAN ENCOURAGE AND REWARD
PEOPLE LIKE ME WHO ARE REALLY
AGENTS OF CHANGE AS OPPOSED TO
AGENTS TO DEFEND THE STATUS QUO.
YOU CAN SAY THAT MERIT AWARD IN
MY CASE DIDN'T GIVE ME ANY
RESOURCES BECAUSE ALL IT DID WAS
GIVE ME ONE LAST RENEWAL, GAVE
ME TIME, NOT MONEY.
GAVE ME TIME, NOT TO HAVE TO
WRITE A GRANT THAT PROBABLY
WOULD HAVE GOTTEN RENEWED
ANYWAY, BUT DID ENCOURAGE ME AND
CONTINUED TO ENCOURAGE ME.
WHAT I SUGGEST TO NORA, WE
CONSIDER GOING BACK TO WHAT
MECHANISMS BY WHICH WE CAN
ENCOURAGE THIS KIND OF AGENTS OF
CHANGE, ONE WAY TO DO IT WOULD
BE TO EXPLICITLY PUT IN THE
BIOSKETCH NOT JUST ELEMENTS
ABOUT HOW YOUR PAPERS HAVE BEEN
IMPACTFUL BUT HOW YOU HAVE BEEN
LEADING, WHAT IS YOUR STATUS AS
A LEADER, MENTORING, TRAINING,
PROVIDING RESOURCES TO YOUNG
INVESTIGATORS, PROVIDING
PERSPECTIVE THAT ENCOURAGES
THEM, AND WE NOW HAVE D.E.I.
STATEMENTS THAT GO INTO OUR
FACULTY MERIT EVALUATION THAT
GOES INTO REWARDS WITHIN OUR
INSTITUTION.
BUT I DON'T NECESSARILY SEE
SOMETHING AS EXPLICIT WHERE WE
CALL OUT INDIVIDUALS AND HOLD
THEM ACCOUNTABLE FOR DOING MORE
THAN JUST GENERATING NEW
IMPACTFUL PAPERS, BUT ALSO BEING
THE OTHER ASPECTS OF OUR JOB,
WHICH ARE MENTORING OUR NEXT
GENERATION.
SO IF WE'RE TALKING ABOUT WHERE
WILL THE MERIT AWARD RECIPIENTS
COME FROM TEN YEARS FROM NOW,
THEY WILL COME FROM US AND OUR
TRAINING IN WHAT WE DO.
I JUST WANT TO PUT IN THAT ONE
SLIGHTLY DEFENSIVE STATEMENT BUT
HOPEFULLY HELPFUL.
>> YEAH, NO, IT'S VERY
IMPORTANT.
THAT'S WHY I SAY IT'S NOT A
SIMPLE ONE.
DEFINITELY WHAT YOU'RE SAYING IS
SOMETHING THAT SHOULD PERMEATE
ALL AWARDS, NOT JUST HOW MANY
PUBLICATIONS BUT WHAT IS YOUR
TRACK RECORD IN ADVANCING THE
SCIENCE, ACTUALLY PROMOTING
DIVERSITY.
THIS IS CLEARLY GOING TO BE ONE
OF THE PARAMETERS WE USED TO
EVALUATE.
AT THE END OF THE DAY IT'S GOING
TO COME OUT WITH THE NOTION HOW
DO WE DISTRIBUTE RESOURCES,ING
WHAT IS OPTIMAL.
AND WHAT -- ALSO IN ACHIEVING
AREAS WHERE WE'RE TRYING TO
BRIDGE.
SO THE MENTORSHIP CHARGE, YOU
HAVE BEEN STELLAR AS A MENTOR IN
THE SENSE OF MINORITIES AND
WE'RE VERY, VERY GRATEFUL.
IT NEEDS EVALUATION, TO WHAT
EXTENT HAVING MERIT FACILITATES
FOR YOU TO DO THAT MENTORSHIP.
IT'S NOT OBVIOUSLY BLACK AND
WHITE.
BUT THANKS FOR ALL OF THE WORK
THAT YOU'VE DONE IN THE SORT OF
MENTORSHIP COMPONENT.
AT THIS TIME DO YOU WANT ME TO
JUMP INTO MY PRESENTATION?
>> I DO.
NEXT PRESENTATION WILL BE MIKE
LAUER BUT YOU'VE GOT ALMOST AN
HOUR.
NOW WOULD BE GREAT.
>> I'M GOING TO TRY TO SHORTEN
SO THERE IS FOR CERTAIN
OPPORTUNITY TO GET QUESTIONS
BECAUSE I WANT THE QUESTIONS.
I WANT TO SHARE MY SCREEN.
SO YOU ALL NEED TO TELL ME IF
YOU SEE IT.
OTHERWISE I'M GOING TO BE
SPEAKING -- OKAY.
HOLD ONE SECOND.
CAN YOU SEE IT?
>> YES.
>> OKAY, GREAT.
I'M GOING TO JUMP RIGHT IN.
THIS IS JUST TO SHOW YOU WHERE
WE ARE.
THAT'S THE ORGANIZATION OF NIDA.
WE'RE STILL IN THE PROCESS OF
SEARCHING AND FINALIZING FOR
DIRECTOR OF THE DPMC.
DR. KURT RASMUSSEN LEFT AND WE
STARTED A SEARCH COMMITTEE AND I
HOPE BY THE NEXT MEETING WE'LL
BE ABLE TO ANNOUNCE THE DIRECTOR
OF DTMC, WE GRATEFUL FOR
EVERYTHING THAT'S BEEN DONE.
THE BUDGET, THESE ARE BUDGETS WE
CURRENTLY HAVE FOR 2022 ENACTED.
YOU CAN SEE BASICALLY NIDA HAS
RECEIVED SIGNIFICANT INCREASE IN
FUNDING.
IF YOU ALSO LOOK AT THE FUNDS WE
GET FROM PROPOSED BY THE
PRESIDENT, THE BUDGETS ACTUALLY
WILL BE -- ARE VERY
SIGNIFICANTLY INCREASED FROM
WHAT REGULAR BUDGETS ARE AND
REFLECTS COMPONENTS, WITH OUR
BASE FUNDING WHICH ALLOWS NIDA
DIRECTLY TO PUT RESOURCES, AND
THE OTHER ONE ALLOCATED THROUGH
"HEAL," WHICH IS MANAGE THE
THROUGH OFFICE OF THE DIRECTOR,
INITIALLY FRANCIS COLLINS, NOW
LARRY TABAK.
AND THAT'S WHOLE SERIES THAT
REQUIRES THERE'S A DIFFERENCE,
MULTI-DISCIPLINARY WORKING
GROUP, DIFFERENT EXECUTIVE
COMMITTEE, THAT REVIEWS ALL OF
THE GRANT PROPOSALS WE SUBMIT SO
THEY CAN DETERMINE WHETHER THEY
ALLOCATE FUNDS OR NOT.
IT'S A MORE COMPLEX AND LENGTHY
PROCESS BUT STILL AT THE SAME
TIME IT'S AN EXTRAORDINARY
OPPORTUNITY THAT WE HAVE TO
SIGNIFICANTLY INCREASE RESOURCES
IN ORDER TO ADDRESS THE OVERDOSE
CRISIS.
HOW ARE FUNDS ALLOCATED FOR
NON-HEAL RESEARCH?
THERE ARE DIFFERENT PROCESS FOR
GETTING IT APPROVED.
NON-HEAL RESEARCH HAS EQUIVALENT
WAY FOR NEUROSCIENCE, BEHAVIORAL
RESEARCH, AND EPIDEMIOLOGY AND
MEDICAL THERAPEUTICS AND CPN
OVERALL.
STRONG PREEMINENCE OF
NEUROSCIENCE AND BEHAVIOR BY
ITSELF.
ON THE OTHER HAND "HEAL" GOAL IS
TO ADDRESS THE OVERDOSE CRISIS
FOCUSING MORE RESOURCES IN TERMS
OF MEDICAL CONSEQUENCES, MANY
THERAPEUTICS FOR OPIOID USE
DISORDER AND OVERDOSES.
26%, ALSO ABLE TO INCREASE
MONEY TO CLINICAL TRIALS NETWORK
THROUGH HEAL FUNDS, FUND FIVE
MORE NODES.
MOST SIGNIFICANT INCREASE ON
RESEARCH THAT RELATES TO
EPIDEMIOLOGY AND SERVICES
RESEARCH.
45% OF OUR "HEAL" FUNDS GO TO
THIS ENDEAVOR.
IN TERMS OF THE OBJECTING I WANT
TO GIVE YOU VERY MUCH I'M GOING
TO BE CONCENTRATING ON PUSHING
THE LIGHT ABOUT WHAT COVID HAS
DONE, HOW WE'RE MOVING THEM
FORWARD AS RELATES TO SCIENCE
THAT IS FUNDED BY NIDA.
I WANT TO UPDATE YOU SHORTLY ON
ADOLESCENT BRAIN COGNITIVE
DEVELOPMENT.
AND WE'LL HAVE MORE DETAIL.
IT'S VERY RELEVANT BECAUSE THIS
HAS BEEN VERY REMARKABLE STUDY
IN TERMS OF HOW IT HAS HELPED US
OBTAIN DATA AND KNOWLEDGE HOW
THE HUMAN BRAIN DEVELOPS THROUGH
ADOLESCENCE AND IMPORTANTLY HOW
THE SOCIAL DETERMINANTS OF
HEALTH IN ADOLESCENCE ARE FROM
THE HISTORY OF THESE ADOLESCENTS
AND MOTHERS AND FAMILIES WHAT
PRECEDED THEM ULTIMATELY
INFLUENCING THEIR BRAIN
DEVELOPMENT, THEIR BEHAVIOR,
THEIR COGNITION.
IT'S BEEN VERY SUCCESSFUL IN
RELEASING THE DATA, BASICALLY AS
CLOSE AS POSSIBLE AS WHEN IT'S
COLLECTED.
IN A FORMAT THAT MAKES IT
AMENABLE FOR INVESTIGATORS NOT
JUST THAT ARE PARTICIPATING
DIRECTLY IN THE ABCD BUT FOR
ANYONE THAT IS NOT
PARTICIPATING, INCLUDING
SCIENTISTS THAT MAY NOT HAVE THE
COMPUTATIONAL RESOURCES THAT
OTHER UNIVERSITIES HAVE BECAUSE
OF ACCESS TO CAPABILITIES ENABLE
THEM TO ANALYZE THE DATA.
I'M GRATEFUL TO DR. DARLING AND
HER TEAM ON THEIR ABILITY TO
ENSURE THE PARTICIPANTS ARE
RETAINED, AND SECURED BY TWO
YEARS OF COVID PANDEMIC, ALL OF
THE DIFFICULTIES THIS CONTAIN,
RETENTION IS 98.1%, QUITE
EXTRAORDINARY.
IN TERMS OF PRODUCTIVITY, LOOK
AT THE METRICS, THE SINGLE
METRICS OF PUBLICATION, YOU CAN
ALSO SEE ABCD STUDY HAS BEEN
ABLE TO PROVIDE RELEVANT VERY
FASCINATING FINDINGS THAT HAVE
BEEN PUBLISHED, BOTH BY ABCD
INVESTIGATORS IN BLUE AND NOT
ABCD INVESTIGATORS.
YOU CAN SEE CLEARLY AS THE YEARS
PROGRESS, THERE ARE MORE
NON-ABCD INVESTIGATORS RELATIVE
TO ABCD INVESTIGATORS THAT ARE
TAKING ADVANTAGE OF THESE
DATASETS WHICH IS EXACTLY WHAT
WE WANTED TO ACHIEVE.
AND AS I SAY, ONE OF THE THINGS
THAT I HIGHLIGHT BECAUSE OF HOW
IMPORTANT AND TRANSFORMATIVE HAS
BEEN IT'S ABILITY TO ADDRESS
QUESTIONS HOW SOCIAL
DETERMINANTS OF HEALTH ARE
INFLUENCING BRAIN DEVELOPMENT
AND WHAT ARE THE FACTORS ONE CAN
INTERVENE IN ORDER TO IMPROVE
THOSE OUTCOMES.
AND SO AS A RESULT, AS WE'RE
DISCUSSING, THE OVERDOSE CRISIS,
WE NEED TO ACTUALLY HIGHLIGHT
ONE OF THE KEY COMPONENTS THAT
WE HAVE IS PREVENTION.
AND PREVENTION OBVIOUSLY HAS
DIFFERENT STAGES BUT PERHAPS
MOST IMPACTFUL ONE IS TO PREVENT
TEENAGERS FROM DRUG
EXPERIMENTATION, NOT JUST DRUG
EXPERIMENTATION BUT ALSO PROVIDE
THEM WITH RESILIENCE THAT WILL
GIVE THEM THE ABILITY TO
NAVIGATE THEIR LIFE AS THEY GO
INTO ADULTHOOD AND HOPEFULLY
ACHIEVE HEALTH EQUITY AND
SUCCESS.
WHAT HAS THE COVID PANDEMIC DONE
WITH DRUG TAKING?
DRUGS DRIVING THE OVERDOSE
CRISIS, BUT BEYOND THAT, BEFORE
I GET INTO IT, I DO WANT TO
HIGHLIGHT THAT THE COVID
PANDEMIC, I THINK WE'VE BEEN
COVERING THIS BECAUSE OF THE
STRESS AND UNCERTAINTY AND
EVERYTHING INCLUDING SOCIAL
ISOLATION HAS LED AMONG ADULTS
TO SIGNIFICANT INCREASE IN DRUG
TAKING.
THIS HAS NOT HAPPENED AMONG
ADOLESCENTS.
AMONG ADOLESCENTS WE'VE SEEN
SIGNIFICANT DECLINE, PRESUMABLY
TO DECREASED OPPORTUNITY TO
SOCIALLY INTERACT WITH OTHERS
WHICH IS NECESSARY DURING THIS
AGE, PARTICULARLY FOR DRUG
CONSUMPTION, IT'S A KEY
COMPONENT.
I'M HIGHLIGHTING TWO STUDIES.
ONE OF THEM THAT HAS LOOKED INTO
TRYING TO IDENTIFY WHO WERE
INDIVIDUALS AT GREATEST RISK AS
RELATES TO CANNABIS.
THE TAXES THE STATES ARE GETTING
FOR SELLING CANNABIS WERE HIGHER
WHEN THE COVID PANDEMIC STARTED,
HAVE CONTINUED TO BE HIGHER.
AN IMPORTANT QUESTION IS WHO ARE
THE INDIVIDUALS AT GREATER RISK,
AND THERE'S BEEN INCREASE IN
BOTH IN TERMS OF NON-MEDICAL AS
WELL AS MEDICAL CANNABIS, BUT
THE FACTORS ACCOUNTING FOR TO A
CERTAIN EXTENT ONE CAN THINK
ABOUT IT, THE REASON WHY THAT
INCREASES YOUR RISK IF YOU'RE A
CANNABIS USER FOR NON-MEDICAL
PURPOSES, THE HIGHEST INCREASES
OBSERVED IN INDIVIDUALS THAT HAD
LESS THAN -- WERE USING IT
MONTHLY OR LESS THAN MONTHLY AS
OPPOSED TO REGULAR WEEKLY USERS.
THE STUDY SHOWS FOR A
PARTICULARLY VULNERABLE GROUP IN
TERMS OF POTENTIAL NEGATIVE
EFFECTS, THAT IS PREGNANT WOMEN.
CLEARLY YOU CAN SEE SIGNIFICANT
INCREASE IN NATURALLY
CONSUMPTION OF MARIJUANA IN THE
COVID PANDEMIC BY PREGNANT
WOMEN, BASED ON KAISER
PERMANENTE AND NORTHERN
CALIFORNIA DATASETS.
THIS IS A SLIDE THAT ACTUALLY --
I'M GOING TO GUIDE OUR SELF
BECAUSE WE NEED YOUR INPUT AND
YOUR QUESTIONS AND YOUR
SUGGESTIONS.
I'M GOING TO BE THROWING AT YOU
DATA THAT I THINK IS VERY
SALIENT IN TERMS OF HOW WE MOVE
THROUGHOUT.
IN THIS GRAPH I HAVE TO THE LEFT
MALES, TO THE RIGHT FEMALES.
I DIVIDED OVERDOSE DEATHS AS A
FUNCTION OF AGE.
15-34, YOUNGER.
OLD IN THE SECOND YOUNGEST,
35-64 YEARS OLD.
AND IN GRAY IS THE PERIOD OF THE
COVID PANDEMIC.
JUST BY LOOKING AT IT, WHETHER
IT IS MALES OR FEMALES, YOUNGER
VERSUS OLDER COHORT CLEARLY IT
DID GO UP, HIGHER.
IT'S ALSO TELLING US SOMETHING.
THIS HAS APPEARED IN OTHER AGE
GROUPS THAT THE RISE STARTED
JUST BEFORE THE COVID PANDEMIC.
BUT IT CONTINUED THEREAFTER.
SO IT'S NOT JUST THE FUNCTION OF
THE COVID PANDEMIC THAT WE'RE
SEEING INCREASE IN OVERDOSE
DEATH, THAT IS CRUCIAL.
I'LL POINT THIS OUT LATER,
SIGNIFICANT IN TERMS OF OUR
ACTIONS, JUMPS AT YOU, LOOK AT
YOUR Y-AXIS.
THIS IS 65, RATE OF 65 PER
100,000 POPULATION FOR MALES.
HERE IS STANDARDIZED TO 35.
CLEARLY YOU SEE FEMALE OVERDOSES
ARE MUCH LOWER THAN MALES.
YOU ALSO SEE THERE ARE
SIGNIFICANT DIFFERENCES ACROSS
GROUPS, ETHNIC AND BASICALLY
RACE AND ETHNICITY.
OVERALL IN TERMS OF ABSOLUTE
NUMBERS, BY THE GROUP WITH THE
HIGHEST MORTALITY, ARE THE
AMERICAN INDIANS AND ALASKA
NATIVES.
THAT'S WHERE WE HAVE THE HIGHEST
RATES OF OVERDOSES.
LOOK AT THE HIGHEST NUMBER OF
OVERDOSES, MALES ON THE OLDER
COHORT OF THE TWO, THERE YOU CAN
SEE AMERICAN INDIANS IS 60,
BLACK AMERICANS ALSO EXTREMELY
HIGH, 61.
IF YOU LOOK AT YOUNGER COHORT
DIFFERENT PROPORTIONALITY,
AMERICAN INDIANS/ALASKA NATIVES
AT 42.
BLACK AMERICANS 25.
CLEARLY HIGHLIGHTING RISK
FACTORS WE ARE OBSERVING ARE
AFFECTED NOT JUST BY RACE AND
ETHNICITY BUT ALSO BY THE AGE OF
THE INDIVIDUALS.
WHEN YOU JUMP INTO THE FEMALES,
YOU CAN SEE HOW THE LINE
SEPARATES FROM THE OTHER AND
BASICALLY AS WELL BOTH FOR THE
15 TO 34 AS WELL AS 35 TO 64
TELLING YOU IN FEMALES THE
DISPARITIES ARE GREATER THAN THE
MALES.
IT'S AMERICAN INDIAN AND ALASKA
NATIVE WOMEN BY FAR WE SEE
GREATEST MORTALITY.
WHAT I ALSO WANT TO HIGHLIGHT
BECAUSE THIS IS SOMETHING WE'VE
NOT SEEN, VERY SIGNIFICANT
INCREASE IN RATE OF MORTALITY
AMONG BLACK AMERICANS 35 TO 64
YEARS OF AGE.
WHAT DOES IT MEAN AND WHY ARE WE
SEEING THIS IS AT THE ESSENCE
TRYING TO DETERMINE INITIATIVES
WE CAN DEPLOY TO HELP ADDRESS
THAT, TO UNDERSTAND IT BETTER,
OF COURSE, BUT ALSO WHAT ARE THE
STRATEGIES HELP REVERSE IT.
AND SO THESE ARE NUMBERS, THE
ONES I'M ALLOWED TO PRESENT TO
YOU, THE CDC IS GOING TO LISTING
THE LATEST NUMBERS WHICH ARE
GOING TO GROW FOR THE LAST 12
MONTHS, ON DECEMBER, THIS IS THE
LAST 12 MONTHS OF NOVEMBER 2021
COMPARED AGAINST THE LAST 12
MONTHS OF 2020.
REMEMBER, ON 2020 THE FIRST YEAR
OF THE PANDEMIC THERE WAS 30%
INCREASE IN OVERDOSE MORTALITY.
THE HIGHEST RATE WE'VE EVER
SEEN.
NOW THAT WE ARE ON THE NOVEMBER
2021, WE'VE SEEN THERE IS A
SIGNIFICANT DECREASE BUT RATES
OF INCREASE IS BASICALLY IN THIS
CASE, 16%.
IT HAS CONTINUED TO INCREASE.
JUNE 2021, WE REACH THE HORRIBLE
MARK MORE THAN 100,000 OVERDOSE
DEATHS, AND THIS IS DATA.
I TOLD YOU MY VIEW, LET'S LOOK
BECAUSE WHAT IT IS TELLING US IN
TERMS OF OVERDOSE CRISIS, THE
NUMBER OF OVERDOSES FROM HEROIN
HAS GONE DOWN.
THE NUMBER OF OVERDOSE DEATHS
FROM PRESCRIPTION OPIOIDS IS
STABLE.
IT HAS NOT CHANGED.
IT'S STILL SIGNIFICANT, I DON'T
WANT TO UNDERESTIMATE IT.
14,000 PEOPLE DYING FROM
OVERDOSE FROM PRESCRIPTION
OPIOIDS BUT NOT AT THE RATE OF
GROWTH WE'RE OBSERVING FOR OTHER
CATEGORIES.
LOOK AT SYNTHETIC OPIOIDS,
FENTANYL.
WE START TO SEE EMERGING
SIGNIFICANT RISES.
I POINTED THIS OUT, PSYCHOSTIM
S TIMULANTS AND METHAMPHETAMINE.
MANY OVERDOSE DEATHS HAVE
COMBINATION WITH BENZODIAZEPINES
OR ALCOHOL OR ALSO
ANTI-CONVULSANT DRUGS.
MORE AND MORE WHAT WE'RE
OBSERVING IN OVERDOSE CRISIS IS
PEOPLE ARE DYING WITH MULTIPLE
SUBSTANCES ON BOARD.
AN IMPORTANT NOTE, I REITERATE,
THERE'S NOT BEEN INCREASE IN
OVERDOSE DEATHS FOR METHADONE,
VERY IMPORTANT BECAUSE IT WAS
NOT CLEAR HOW FACILITATED EFFECT
OF TAKEHOME METHADONE COULD
AFFECT OVERDOSE RATES.
IT HASN'T, AND THE DATA SHOWN IN
THE PAST HAS SHOWN THAT IT'S
ACTUALLY IMPROVED RETENTION IN
TREATMENT.
POSITIVE EFFECT, NO EVIDENCE
IT'S HAD A NEGATIVE IMPACT IN
PROMOTING, CORRECTING TO
OVERDOSE, THE SAME DAY,
SIMILARLY FOR BUPRENORPHINE, THE
MEASURE, ACTUALLY THE ABILITY TO
PRESCRIBE BUPRENORPHINE BECAME
MUCH EASIER WITH THE COVID
PANDEMIC, AND THAT HAS NOT
RESULTED IN INCREASING OVERDOSE
FROM BUPRENORPHINE, JUST AS FOR
METH TONE, THAT'S LOW THRESHOLD
INTO BUPRENORPHINE, FACILITATE
RETENTION IN TREATMENT.
RETENTION IN TREATMENT,
BUPRENORPHINE, METHAMPHETAMINE,
NALTREXONE, OVERDOSE REVERSAL,
THEY ARE VERY EFFECTIVE AND YOU
HAVE READ MEDICATION FOR OPIOID
USE DISORDER SAVES LIVES,
CONSENSUS RETRO BY NATIONAL
ACADEMY OF MEDICINE SIGN, A
PAPER SHOWS INDEPENDENT STORY
HOW DEFECTIVE THESE ARE FOR
PREVENTING OVERDOSE.
THESE DATA PLOT REDUCEED RISK OF
OVERDOSE IN PREGNANT WOMEN GIVEN
MEDICATION FOR OPIOID USE
DISORDER AND SHOWS ACTUALLY --
CERTAINLY THE LONGER YOU ARE ON
MEDICATION FOR OPIOID USE
DISORDER, THE GREATER THE
PROTECTION.
SO IF YOU ARE 40 WEEKS TO YOUR
PREGNANCY WITH MEDICATION FOR
OPIOID USE DISORDER THAT ENTAILS
90% REDUCTION IN NON-FATAL
OVERDOSES.
THESE HIGHLIGHT HOW CRUCIAL IT
IS THAT WE ADDRESS AND PROVIDE
WITH MEDICATION FOR OPIOID USE
DISORDER.
SO THE EVIDENCE IS OUT THERE.
BUT UNFORTUNATELY NOT EVERYONE
THAT REQUIRES THOSE TREATMENTS
ARE GIVEN THEM.
THIS IS DATA FROM THE SAMHSA,
DETERMINING THOSE INDIVIDUALS
THAT HAVE AN OPIOID USE DISORDER
IN THE UNITED STATES THAT
RECEIVE MEDICATION FOR OPIOID
USE DISORDER IN THE PAST YEAR OF
PUBLIC SURVEY AND IT SHOWS THAT
JUST A LOW PERCENTAGE OF THEM
ACTUALLY WERE GIVEN ACCESS TO
MEDICATION FOR OPIOID USE
DISORDER.
THIS IS DESPITE ALL OF THE
EVIDENCE THAT SHOWS THIS IS
PROBABLY THE MOST EFFECTIVE
INTERVENTION ALONG WITH
DISTRIBUTION AND ACCESS TO
NALOXONE THAN FOR PREVENTING
OVERDOSE.
EVEN DATA IS SHOWING IT'S VERY
EFFECTIVE, WE'RE AWARE NOT
PROVIDING THIS TREATMENT, THAT'S
A KEY COMPONENT.
WITH PREGNANT WOMEN THE LONGER
YOU RETAIN PEOPLE IN TREATMENT
THE BETTER YOU ARE AT PREVENTING
DISORDERS.
I WANT TO FOR THAT PURPOSE
HIGHLIGHT STUDY THAT WAS JUST
RECENTLY PUBLISHED.
IT'S A METH ANALYSIS
INVESTIGATION TO DETERMINE A BIG
CHALLENGE, WE TENSION OF PEOPLE
IN KNOWED KNOWED.
THERE'S ONE POINT, NOT GIVING
MEDICATION FOR OPIOID USE
DISORDER, EVERYONE THAT WOULD
BENEFIT, BUT THE OTHER SIDE OF
THE COIN WE'RE STILL NOT ABLE TO
RETAIN PEOPLE ON MEDICATIONS FOR
OPIOID USE DISORDER.
SO ONE QUESTION SCIENTIFICALLY
FOR WHICH CLINICAL TRIALS
NETWORK, SOME RESEARCH FUNDED IS
AIMING WHAT IS OPTIMAL
INTERVENTION THAT CAN ENSURE
TREATMENT RETENTION.
METHADONE IS SUPERIOR FROM
BUPRENORPHINE, WE KNOW THAT FROM
OTHER STUDIES, BUPRENORPHINE IS
SUPERIOR TO NALOXONE, AND EITHER
MEDICATION IS SUPERIOR TO
CONTROL.
BUT REGARDLESS, I THINK THAT THE
NUMBERS THEY ARE TELLING US,
THIS SUMMARIZES LEVEL OF
RETENTION ON RANDOMIZED CLINICAL
TRIALS WHICH ONE WOULD EXPECT,
UNDER OPTIMAL CONDITIONS, YOU
STILL HAVE -- THERE ARE
DIFFERENCES IN THE RANGE OF TIME
THEY ARE FOLLOWING THE RCT.
BASICALLY BETWEEN 50 AND 60%, 6
ARE 64% FOR METHADONE TREATMENT.
EXPAND AND RETAIN TREATMENT FOR
LONGER.
THEREFORE WE HAVE PUT PROJECTS
BASICALLY PRIORITIZING
IMPLEMENTATION RESEARCH, TAKING
ADVANTAGE OF UNIQUE RESOURCES
THAT WE HAVE, SO INVESTIGATORS
ACROSS THE COUNTRY.
ONE OF THEM THAT HAS BEEN
EXTRAORDINARILY VALUABLE HAS
BEEN OUR CLINICAL TRIALS NETWORK
THAT ENABLED US TO DEPLOY
INTERVENTION TO MAXIMIZE HEALTH
CARE SCREENING IN SCREENING AND
TREATMENT WITH OPIOID USE
DISORDER AND SUBSTANCE USE
DISORDERS.
THE OTHER OPIOID INNOVATION
NETWORK WAS LAUNCHED WITH "HEAL"
FUNDS, ENABLED US TO CREATE A
NETWORK OF PRACTITIONERS AND
AND -- PRACTITIONERS IN JUSTICE,
TO BRING THEM TOGETHER WITH
HEALTH CARE PROVIDERS, IN
JUSTICE SETTINGS, TO INFORM THE
MOST EFFECTIVE INTERVENTIONS.
AND THE THIRD BIG PROJECT I WANT
TO HIGHLIGHT IS THE HEALING
COMMUNITY STUDY WAS TARGETED 67
COMMUNITIES IN FOUR STATES WITH
VERY HIGH RATES OF OVERDOSE
DEATHS TO BRING TOGETHER
EVIDENCE-BASED INTERVENTIONS IN
A BATTERY OF INTEGRATION ACROSS
HEALTH CARE, JUSTICE AND
COMMUNITY, ACROSS THE STATES AND
ACADEMIC CENTERS TO BRING
TOGETHER ACTUALLY A
DEMONSTRATION THAT ONE CAN
BASICALLY SIGNIFICANTLY REDUCE
OVERDOSE DEATHS BY PROVIDING
INTERVENTION OF EVIDENCE-BASED
PRACTICES AND DEPLOYING THEM.
THIS IS AS MUCH 9/20/21 TO NOW,
STUDIES ARE ONGOING, 18 STUDIES.
THERE'S 25 WE'RE COLLECTING
DATAY, 21 ON DATA ANALYSIS, AND
111 ALREADY AT COMPLETION.
THESE STUDIES ARE ADDRESSING
TREATMENT RESEARCH, MINORITY
POPULATIONS.
WE HAVE SEVEN ACTIVE STUDIES,
SEVERAL BEING DEVELOPED.
SCREENING AND PREVENTION, TWO
ACTIVE STUDIES, TWO PENDING
AWARDS.
EXPANSION OF METHADONE FOR
OPIOID USE DISORDER IN PRIMARY
CARE, AGAIN, WE HAVE
BUPRENORPHINE IN PRIMARY CARE
AND THAT HAS SHOWN THAT IT CAN
LEAD TO VERY OPTIMAL OUTCOMES
BUT WE DON'T HAVE METHADONE,
DEMONSTRATING THAT IT IS
EFFECTIVE AND HELP US DEVELOP A
MODEL THAT WOULD BE EXPORTED TO
OTHER SIDES COULD BE VALUABLE.
THERE ARE TWO ACTIVE STUDIES
ONGOING.
STUDIES THAT RELATE TO HOW DO WE
OPTIMIZE EFFECTIVE TREATMENT IN
EMERGENCY DEPARTMENTS AND BEING
VERY ABLY SPEARHEADED THROUGH
GAIL D'ONOFRIO AND HER TEAM,
THREE TRIALS, THREE ANCILLARY
STUDIES, IN TERMS OF EXPANDING
THE USE OF MEDICATION FOR OPIOID
USE DISORDER, TAKING ADVANTAGE
OF COMMUNITY PHARMACISTS WHICH
AGAIN WOULD ENABLE US TO PROVIDE
TREATMENT AND SUPPORT TO
INDIVIDUALS THAT I GREW UP IN
PLACES WHERE HEALTH CARE IS NOT
AVAILABLE, EASILY AVAILABLE TO
GET THEM.
ONE PILOT COMPLETED WITH
POSITIVE RULES, ONE STARTING
THIS COMING SUMMER.
AND PROJECTS FOR STIMULANT USE
DISORDER WHICH AGAIN HAS NOW
WE'RE SEEING SIGNIFICANT
CONTRIBUTION TO OVERDOSE DEATHS,
THERE ARE TWO ACTIVE STUDIES,
AND TWO PENDING INITIATIONS
BECAUSE THEY ARE WAITING FOR
STUDY MEDICATIONS WHICH HAVE
BEEN DELAYED BECAUSE OF COVID,
WHICH HAS BEEN MADE WORSE
THROUGH COVID.
I ALSO WANT TO HIGHLIGHT
SOMETHING I HAD NOT SEEN
TABULATED UNTIL RECENTLY BUT
MADE ME HAPPY WE HAVE SUCH
NUMBERS.
I WANTED TO BE SURE IN THE
RECRUITMENT ACROSS PARTICIPANTS
FOR CTN WE WERE RECRUITING
MINORITY GROUPS, 27% OF ALL OF
THE PARTICIPANTS THAT HAVE BEEN
INCLUDED IN CTN STUDIES ARE
AFRICAN AMERICAN.
15% HISPANIC, 6% MULTI-RACE, 3%
ASIAN AMERICAN, 1% ALASKA
NATIVE, 39% WOMEN.
WE'RE ABLE TO RECRUIT DIVERSITY.
THERE ARE AREAS WE CAN EXPAND
LIKE ASIAN AMERICAN AND THE
AMERICAN INDIAN AND ALASKA
NATIVE.
WE HAVE A NEED TO TRUST IN THIS
COMMUNITY.
ONE SHOULD AIM TO EXPAND TO
EXPAND INCLUSION OF WOMEN.
THIS IS A NUMBER OF PUBLICATIONS
THAT HAVE RESULTED FROM CTN, IN
THE LAST 12 MONTHS IS 66
PUBLICATIONS.
69 ARE PENDING REVIEW.
CTN HAS HELPED US DEPLOY SORT OF
HIGHER LEVEL TO EVALUATE
EFFECTIVENESS OF INTERVENTIONS
FOR WHICH THERE WAS A
PRELIMINARY EVIDENCE OF POSITIVE
EFFECT.
IMPORTANTLY HAS BROUGHT IN THE
HEALTH CARE SYSTEMS TO BASICALLY
BE ACTIVELY INVOLVED IN THE
SCREENING AND TREATMENT OF
INDIVIDUALS WITH SUBSTANCE USE
DISORDER.
FOR THE JUSTICE COMMUNITY OPIOID
INNOVATION NETWORK I WANT TO
HIGHLIGHT THREE MAJOR
ACHIEVEMENTS.
ONE OF THEM, COMPLETION OF THE
SURVEY THAT ACTUALLY WAS
EVALUATING EXTENT TO WHICH JAILS
AND PRISONS WERE OFFERING ACCESS
TO MEDICATION FOR OPIOID USE
DISORDER AND OUT OF THAT SURVEY
ACTUALLY COMES ACROSS THAT 43%
OF JAILS IN COMMUNITIES OFFER
ALL THREE, 7% STATE PRISONS.
THE NOTION TO THE EXTENT WE CAN
PROVIDE ALL THREE MEDICATIONS
FOR OPIOID USE DISORDER, NOT
JUST ONE, CURRENTLY THE CASE FOR
MOST JAILS AND PRISONS, WE CAN
SIGNIFICANTLY IMPROVE OUTCOME.
THERE WAS ALSO PILOT STUDY THAT
WAS PUBLISHED, THAT COMPARED
OUOMES ON EXTENDED RELEASE
BUPRENORPHINE, AND PRIOR TO FROM
JAILS THOSE THAT WERE GIVEN
EXTENDED RELEASE BUPRENORPHINE
VERSUS THOSE THAT WERE GIVEN
JUST THE REGULAR BUPRENORPHINE
AND SHOW SIGNIFICANT IMPROVED
OUTCOMES WHEN EXTENDED RELEASE
BUPRENORPHINE VERSUS IMMEDIATE
RELEASE BUPRENORPHINE, IT'S A
PILOT STUDY PRESENTED AT LAST
COUNCIL, REPLICATING FINDINGS IN
A LARGER GROUP OF JAILS.
AND THEN THE LAST ONE IS ONE
THAT RELATES TO MEDICAID AND
INCARCERATION, REPORTING
MEDICAID PRE-ENROLLMENT PRIOR TO
RELEASE SIGNIFICANTLY INCREASES
ACCESS TO MEDICATION, IN THIS
CASE SEVEN-FOLD, THAT WAS AN
INTERVENTION THAT SIGNIFICANTLY
DECREASES RACIAL DISPARITIES.
IF YOU DO THE OTHER IMPORTANT
STUDY, IF YOU DO RECEIVE
MEDICATION FOR OPIOID USE
DISORDER, WHILE YOU'RE
INCARCERATED, THAT DOES NOT
CHANGE MEDICATION COST BUT DOES
DECREASE FROM EMERGENCY CARE,
INDICATIVE OF PREVENTING ADVERSE
CONSEQUENCES THAT SIGNIFICANTLY
CONTRIBUTE TO EMERGENCY VISIT IN
THIS POPULATION.
THE HEALING COMMUNITY STUDY, THE
GRADE 1 INTERVENTION WAS OF THE
67 COMMUNITIES, HALF WERE
RANDOMIZED TO TREATMENT
INTERVENTIONS AS USUAL.
ONES THAT RECEIVED INTERVENTION
FOR HEALING COMMUNITY STUDY
INCLUDING EXPANDED ACCESS TO
MEDICATION FOR OPIOID USE
DISORDER, EDUCATION AND EXPANDED
ACCESS TO NALOXONE, AND
PREVENTION INTERVENTION SUCH AS
IMPROVING PRESCRIPTION FOR
OPIOID FOR MANAGEMENT OF PAIN,
ALONGSIDE BUILDING AN
INFRASTRUCTURE FOR DATA
COLLECTION AND COMMUNICATION.
THAT STUDY IS ABOUT TO BE
COMPLETED IN JUNE 2022.
AT THAT POINT THEY WILL INITIATE
INTERVENTION FOR THE COMMUNITIES
WHICH WILL START IMPLEMENTATION
OF THE MODEL, ON JULY 2022.
THIS WILL ENABLE US TO COMPARE
THE TIMELINES FOR WHEN THE WAVE
ONE, BETWEEN WAVE ONE AND WAVE
TWO, THEY HAVE NOT RECEIVED
THEM, BUT WE ALSO GIVE THE
OPPORTUNITY FOR WAVE TWO
COMMUNITY TO TAKE ADVANTAGE OF
IMPLEMENTATION OF THE MODEL.
AND THIS BRINGS ME TO THE POINT
THAT I HAD JUST SHOWED YOU IN
TERMS OF DATA AND I JUST
PRESENTED THIS.
THE OVERDOSE DEATHS CONTINUE TO
INCREASE.
I WANT YOU TO ACTUALLY PAY
ATTENTION, FROM THE PERSPECTIVE
OF WHERE WE ARE, WHAT IS IT
TELLING US ON AREAS OF RESEARCH
THAT ARE NECESSARY.
AGAIN, I'M GOING TO HIGHLIGHT IT
IS TELLING US THAT JUST
ADDRESSING THE ISSUE OF
PRESCRIPTION OPIOIDS IS
IMPORTANT, BUT IT'S BASICALLY
NOT SUFFICIENT ANYMORE.
WE NEED TO CONTINUE DOING THE
WORK ON IMPROVING PRACTICES AND
PREVENTING PEOPLE THAT ARE
GETTING OPIOID MEDICATIONS TO
ACTUALLY DIVERT MEDICATIONS, WE
ALSO NEED TO CLEARLY UNDERSTAND
IN THE VIEWS THAT ARE ACTUALLY
EXPOSED TO DRUGS, ILLICIT DRUGS,
THAT'S WHAT IS DRIVING
OVERDOSES.
THE NOTABLE EXPANSION OF
METHAMPHETAMINE WHICH AT ONE
POINT WAS JUST PREDOMINANTLY IN
THE WEST COAST, NOW WE'RE SEEING
IT ALL OVER THE UNITED STATES.
WHICH BRINGS ME TO THE LAST DATA
POINT I WANTED TO SHOW YOU
BECAUSE THIS, AGAIN, CERTAINLY
TOOK ME BY SURPRISE, WHICH IS
DATA TELLING US OVERDOSE
FATALITIES AMONG ADOLESCENTS TO
22, AND OVERDOSE DEATHS OVERALL
AMONG TEENAGERS, THIS IS 19
YEARS OF AGE OR LOWER, ALWAYS
HAVE BEEN LOWEST, .5, BASICALLY
TRENDING DOWN, IF ANYTHING.
BUT LOOK AT THE BLUE LINE, THE
LINE OF FENTANYL OVERDOSES,
SOMETHING THAT WE HAVE NOT SEEN
IN THE PAST, STARTED ACTUALLY
VERY LOW NUMBERS IN 2015.
AND NOW WE BASICALLY ARE OVER
1.5 PER 100,000 POPULATIONS, YOU
CAN SEE THE VERY STEEP RISE.
I TOLD YOU WHEN I WAS SHOWING
YOU THE DATA FOR MEN AND WOMEN
ACROSS RACE/ETHNICITY AND AGES,
YOU START TO SEE RISE IN
OVERDOES DEATH JUST BEFORE THE
PANDEMIC.
AND I HIGHLIGHTED THAT BECAUSE
IT TELLS US, YES, THE PANDEMIC
HAS NOT HELPED BUT THE PROBLEM
STARTED BEFORE THE PANDEMIC.
THE QUESTION IS WHAT HAPPENED
THAT SO DRAMATICALLY OCCURRED
DURING THIS YEAR THAT CONTINUES
TO HAPPEN BECAUSE WE ARE
OBVIOUSLY SEEING SIGNIFICANT
RISE IN OVERDOSE DEATHS.
YOU SAY THE ISSUE IS THAT
TEENAGERS DO NOT CONSUME HEROIN.
WE HAVE LOWEST RATES OF
CONSUMPTION EVER, MONITORING
SINCE 1979, THE LOWEST WE'VE
EVER RECORDED.
WE HAVEN'T BEEN RECORDING
FENTANYL BECAUSE IT'S NOT
SOMETHING THEY ENDORSE USING.
WHAT TEENAGERS DO USE IS ALCOHOL
AND MARIJUANA BUT ENDORSE
PRESCRIPTION DRUGS, LIKE TO
PREPARE FOR AN EXAM OR GET HIGH
AND PARTY OR BENZODIAZEPINES
BECAUSE THEY ARE ANXIOUS OR TO
GET HIGH AT PARTIES MIXED WITH
ALCOHOL.
OPIOID THEY MAY CONSUME BECAUSE
THEY HAVE PAIN OR ALSO TO GET
HIGH AT PARTIES WITH TAKING
PRESCRIPTION DRUGS SO WE KNOW
THEY DO FAVOR THEM.
THIS IS DRAMATIC IMPACT,
CONTINUES TO RISE, ILLICITLY
MANUFACTURED PRESCRIPTION DRUGS
THAT CONTAIN FENTANYL.
AND FROM 2018 TO 2021 YOU CAN
SEE, A REFLECTION OF WHAT'S IN
THE MARKET, BECAUSE IT ALSO
DEPENDS HOW EFFECTIVE THEY ARE
AT GETTING THESE DRUG SEIZURES.
WHAT WE SEE OVER THREE YEARS 50
FOLD INCREASE IN NUMBER OF
SEIZURES FROM DRUGS THAT CONTAIN
FENTANYL, AND 30% AT LEAST OF
THOSE ILLICITLY MANUFACTURED
PRESCRIPTION PILLS ACTUALLY
CONTAIN A DOSE OF FENTANYL
THAT'S SUFFICIENT TO PRODUCE A
LETHAL OVERDOSE.
SO WE ARE HYPOTHESIZING.
AGAIN, THERE'S NO DATA.
JUST, AGAIN, THE DATA I'M
SHOWING YOU IS VERY RECENT.
THAT'S ONE OF THE REASONS WE'RE
OBSERVING SIGNIFICANT RISE IN
OVERDOSES FROM FENTANYL MAY
REFLECT THE EXPOSURE OF
TEENAGERS TO THESE ILLICITLY
MANUFACTURED PRESCRIPTION DRUGS
THAT CONTAIN FENTANYL, YOU CAN
SEE WE'RE RISING BEFORE THE
COVID PANDEMIC.
AND THEY CONTINUE TO RISE, WHICH
ACTUALLY HIGHLIGHTS WHAT IS IT
WE NEED TO ADDRESS BECAUSE IT'S
NOT JUST TEENAGERS THAT ARE
USING ILLICITLY MANUFACTURED
PRESCRIPTION DRUGS.
PEOPLE, ADULTS GET PRESCRIPTION
DRUGS FROM ILLICIT MARKETS
BECAUSE THEY CAN NOT SLEEP, HAVE
PAIN, ARE ANXIOUS.
EASY TO GET HANDS ON PILLS THAT
CONTAIN FENTANYL, THEY ARE
HIGHLY OVERDOSING.
PAIN TREATMENTS ARE NOT
SUFFICIENT TO ADDRESS OVERDOSE
CRISIS.
WE NEED TO CONTINUE TO ADVANCE
THE SCIENCE TO PROVIDE WITH
SAFER AND EFFECTIVE PAIN
TREATMENTS, AS WELL AS MODEL OF
CARE SO PEOPLE THAT HAVE THE
NEED FOR OPIOIDS ARE GETTING THE
MAXIMUM BENEFITS AND MINIMAL
HARMS FROM THEIR USE.
WE NEED TO DO THAT.
OTHERWISE THEY GO INTO THE
ILLICIT MARKET.
NOW INCLUDING ILLICIT
PRESCRIPTIONS IS A HIGH RISK
MARKET WITH HIGH RISK FOR
OVERDOSE.
WE'VE KNOWN ALL ALONG USE OF
MEDICATION FOR OPIOID USE
DISORDER ALONG WITH NALOXONE IS
THE MOST EFFECTIVE INTERVENTION
TO PREVENTING OVERDOSES BUT
REALIZE IT'S NOT SUFFICIENT.
WE NEED TO IMPROVE ON RETENTION
AND IMPROVE ON RECOVERY.
BUT WE NEED TO EXPAND TREATMENT
FOR INDIVIDUALS WITH OPIOID USE
DISORDER BECAUSE WE'RE SEEING
INCREASINGLY PEOPLE THAT ARE
BASICALLY DYING WITH USE OF
COCAINE AND METHAMPHETAMINE,
THEY DO NOT KNOW THEY WERE
ACTUALLY CONSUMING COCAINE OR
METHAMPHETAMINE THAT ACTUALLY
HAD FENTANYL.
75% OF THOSE DEATHS FROM COCAINE
HAVE FENTANYL.
WE KNOW MORE THAN 60% OF THOSE
DEATHS FROM METHAMPHETAMINE
CONTAIN FENTANYL.
SO WE NEED TO ACTUALLY HIGHLIGHT
HOW CRUCIAL IT IS THAT WE
DEVELOP TREATMENTS FOR OTHER
SUBSTANCE USE DISORDERS.
NALOXONE HAS BEEN VERY USEFUL
REVERSING OVERDOSES, AND
ACTUALLY EFFECTIVE, EVEN FROM
FENTANYL, PROVIDED YOU GIVE IT
RAPIDLY AT SUFFICIENTLY HIGH
DOSE AND THAT IT MAY REQUIRE
REDOSING TO AVOID
RENARCOTIZATION BUT IT IS VERY
EFFECTIVE.
THE COMBINATION, THAT PICTURE,
NALOXONE IS LIKELY TO BE MUCH
LESS EFFECTIVE IN REVERSING
OVERDOLES OF COMBINATION OF
METHAMPHETAMINE WITH FENTANYL.
ACTUALLY WHEN WE SPEAK ABOUT
METHAMPHETAMINE OVERDOSE, I ASK
THE QUESTION, WHAT DO WE REALLY
EVEN MEAN BY A METHAMPHETAMINE
OVERDOSE?
AND IT IS MUCH SIMPLER TO DEFINE
OVERDOSE WITH OPIOIDS, BUT THESE
ARE RESEARCH QUESTIONS,
CLARIFICATIONS THAT ARE
NECESSARY IN ORDER TO DEVELOP
TOOLS, GUIDELINES OF HOW TO
OPTIMALLY REVERSE STIMULANT
OVERDOSE BY ITSELF OR WHEN
COMBINED WITH OTHER DRUGS.
THE DATA THAT I JUST SHOWED YOU
INCLUDING SIGNIFICANT RISE WE'RE
SEEING IN OUR LESSONS,
HIGHLIGHTS AGAIN HOW CRUCIAL
PREVENTION IS.
AND THAT PREVENTION DRUG USE,
INTERVENTION, SHOULD GO WAY
BEYOND PREVENTION FOR USE OF
OPIOIDS WHICH WE'VE KNOWN ALL
ALONG HAS TO BE PREVENTING
INDIVIDUALS FOR THE USE OF
SUBSTANCES AND UNDERSTANDING
INTERVENTIONS HAVE TO BE
DEPLOYED, HOW TO DEPLOY, AS A
FUNCTION OF AGE AND THE
CONDITIONS OF INDIVIDUALS.
BUT THIS IS AN AREA WHERE
ACTUALLY WE HAVE AN OPPORTUNITY
TO SIGNIFICANTLY FEEL THE
INFRASTRUCTURE THAT WILL MAKE IT
EASIER FOR HEALTH CARE TO
IMPLEMENT.
IT'S ALSO CLEAR THAT WE NEED
MORE TIMELY DATA, INCLUDING
TIMELY REPORTING OF FATAL
OVERDOSES, WHAT TYPE OF DRUGS
WERE INVOLVED AND WE NEED MORE
TIMELY DATA OF EMERGING NEW
DRUGS AND DRUG COMBINATIONS.
FOR EXAMPLE, WE HAVE JUST FROM
THE NEWSPAPER INCREASED REPORTS
OF THE USE OF XYLAZINE, ON
OVERDOSES, WHAT ARE THE DRUGS
WE'RE NOT NECESSARILY MONITORING
THAT MAY BE CONTRIBUTING TO
OVERDOSES?
XYLAZINE IT IS USED AS
ANESTHETIC FOR VETERINARY
MEDICINE BUT IS USED WITH
FENTANYL COMBINED IN ORDER TO
PROLONG ITS DURATION.
THE OTHER SYNTHETIC OPIOIDS,
SOME MORE POTENT THAN FENTANYL,
OTHERS LESS POTENT, INCREASINGLY
APPEARING IN REPORTS FROM SOCIAL
MEDIA AND OTHER COUNTRIES TOO.
AND THEN THE LAST ELEMENT IS
SOCIAL DETERMINANTS OF HEALTH.
ONE OF THE ISSUES THAT WE HAVE
ALWAYS HAD TROUBLE WITH FOR
THOSE THAT OPPOSE THEM, THIS
MODEL OF, WELL, SOCIAL UNJUSTICE
PERPETUATING, THAT MEANS IT'S
NOT A DISEASE.
THESE ARE NOT CONTRADICTORY.
WE KNOW SOCIAL DETERMINANTS OF
HEALTH CONTRIBUTE TO A WIDE
VARIETY OF DISEASES, AND THEY
ARE CRUCIAL, TO THE EXTEND YOU
CAN IMPROVE THOSE DISPARITIES
YOU CAN IMPROVE HEALTH,
OBVIOUSLY TRUE FOR THE CASE OF
SUBSTANCE USE DISORDER.
I HAVE A PROPOSAL FOR
PREVENTION, TAKING ADVANTAGE OF
YOU AS A COUNCIL TO ACTUALLY
REACT AND GIVE SUGGESTIONS.
WE DON'T IN TERMS OF
PREVENTION -- WE HAVE BEEN
TRYING TO PUSH FORWARD THE IDEA
OF SCREENING AND INTERVENTION
FOR SUBSTANCE USE DISORDER, FOR
MILD SUBSTANCE USE DISORDER,
THIS HAS NOT GOTTEN TRACTION.
ONE OF THE THINGS WE'RE
PROPOSING IS RENAMING THE
INTERVENTION AS PRE-ADDICTION
WITH CONCEPT OF TRYING TO
EMULATE WHAT PREDIABETES FIELD
DID IN 2000 TO TRY TO GET
ATTENTION AND RESOURCES AND
REVERSEMENT FOR INTERVENTIONS
THAT WOULD HELP INDIVIDUALS THAT
DID NOT HAVE DIABETES BUT
INDICATORS THAT WERE INDICATED
HIGH LEVEL OF RISK.
WE WOULD LIKE TO MOVE THIS
FORWARD TO GENERATE THE SAME
TYPE OF EVIDENCE THAT WOULD
FACILITATE THE REVERSEMENT WHICH
WOULD THEN INCENTIVIZE SCREENING
AND INCENTIVIZE DEVELOPMENT OF
TREATMENT OR INTERVENTIONS FOR
PRE-ADDICTION.
THERE ARE TWO BIG GAPS IN HERE
THAT PUT IS AT A TREMENDOUS
DISADVANTAGE FROM THE DIABETES
FIELD.
ONE IN MANY WAYS DEFINING
PREDIABETES, IT'S EASIER THAN
DEFINING PRE-ADDICTION.
THERE'S NEED TO COME UP WITH
WAYS OF IDENTIFYING SUCH A
STAGE.
WE CAN TAKE ADVANTAGE OF THE
DSM-V DIAGNOSIS IDENTIFYING
SEVERITY FROM MILD TO MODERATE
VERSUS SEVERE SUBSTANCE USE
DISORDER AND COULD START BY
IDENTIFYING CERTAINLY A
PRE-ADDICTION PHENOTYPE, PERHAPS
ONE THAT'S MILD OR MODERATE.
AND WE KNOW THAT IN MILD CASE OF
OPIOID USE DISORDER USE OF
MEDICATIONS MAY NOT BE
INDICATED.
MORE IMPORTANTLY IF YOU DO
IDENTIFY, WHAT ARE GOING TO BE
THE EFFECTIVE INTERVENTIONS FOR
SUCH A CONDITION?
WE HAVE ONGOING PROJECTS,
CURRENTLY THROUGH HEAL-FUNDED
GRANTS THAT ARE LOOKING AT
THRESHOLD INTERVENTION, TO HELP
ADDRESS MILD OPIOID USE DISORDER
AND WHAT MAY BE THE BEST
OUTCOMES.
SO THIS IS AN AREA THAT WE'RE
LOOKING AT THESE NUMBERS,
IDENTIFYING, SHOWING DIFFERENT
PANORAMA FROM THE PAST, WHERE
THE EXPERIMENTATION WITH DRUGS
CAN ACTUALLY RESULT IN AN
OVERDOSE, RESULTING IN
OVERDOSES, CERTAINLY WE'RE
SEEING WITH TEENAGERS.
THE LAST SLIDE TO HIGHLIGHT THE
OTHER ELEMENTS WE'RE WORKING
WITH VERY ACTIVELY, VERY, VERY
SUCCESSFULLY, TO OFFICE OF
TRANSLATION AND INNOVATION
RESEARCH IS DEPLOYMENT AND
CREATION OF COMPANIES THAT CAN
BRING INNOVATION INTO THE
SUBSTANCE ABUSE FIELD.
HERE ARE SOME EXAMPLES OF
COMPANIES FUNDED BY OUR SBIR AND
STTR PROGRAMS ADDRESSING
PRIORITIES FOR HHS TO ADDRESS
THE OVERDOSE CRISIS.
PRIMARY PREVENTION, HIGH
REDUCTION, EVIDENCE-BASED
TREATMENT AND RECOVERY SUPPORT.
AND THESE ARE JUST A COUPLE OF
THEM BUT I'M GOING TO HIGHLIGHT
TWO OF THEM.
ONE OF THEM IS THE SUBJECT OF
ONE OF THE MAIN ARTICLES OF THE
"NEW YORK TIMES MAGAZINE" ON
LAST -- NOT LAST WEEKEND BUT THE
WEEKEND BEFORE THAT, A COMPANY
THAT WAS FUNDED THROUGH NIDA,
HAS ACTUALLY BEEN QUITE
SUCCESSFUL IN DEPLOYING VIRTUAL
REALITY INTERVENTION RESULTING
IN PATIENTS THEY TESTED THROUGH
DRAMATIC REDUCTION IN PAIN THAT
WAS ACHIEVED AACHIEVED.
THIS IS ANOTHER ONE, AGAIN A
COMPANY LAUNCHED THROUGH THE
SBIR PROGRAM, YOU SEE HERE WHEN
THE COMPANY BECAME PUBLIC, VERY,
VERY HIGH SUCCESS, THE FIRST
COMPANY THAT GOT FDA APPROVAL
FOR TREATMENT OF SUBSTANCE USE
DISORDER.
THESE INVESTMENTS ON INNOVATION
AND ACCELERATION OF KNOWLEDGE
HAVE BROUGHT UP PROBLEMS THAT
ARE EXTREMELY VALUABLE FOR
PEOPLE WITH SUBSTANCE USE
DISORDERS, I MEAN, MOTHERS
HAVING BABIES, COVERS A VERY
WIDE RANGE INCLUDING HOW DO WE
ADDRESS SOME OF THE MAJOR
CHALLENGES WE HAVE TO ADDRESSING
SOCIAL DISPARITIES, THAT MADE
PEOPLE SUBSTANCE USE DISORDER AT
GREATER RISK.
THERE ARE TWO MEETINGS I WANT TO
HIGHLIGHT, NIDA VIRTUAL RESEARCH
TEAM MEETING THAT TOOK PLACE,
STILL TAKING PLACE VIRTUALLY.
I WANT TO HIGHLIGHT IT.
IT'S THE FIRST IN ITS KIND, VERY
MUCH IN THE LINE OF WHAT IS IT
WE CAN DO PROACTIVELY TO BRING
IN MINORITY SERVING INSTITUTIONS
AND MINORITY RESEARCHERS INTO
ALL OF THE SPACE THAT RESEARCH
SPACE THAT WE'RE DOING AND
FUNDING AT NIDA.
SO THIS WAS IN PARTNERSHIP WITH
HOWARD UNIVERSITY AND NIDA, AND
I WANT TO THANK VERY MUCH BOTH
LEADERSHIP.
AND, AGAIN, WE ARE PLANNING TO
PUSH, I THINK THERE ARE MANY
WAYS WE CAN BRING FORWARD
CREATIVITY AND UNIQUE
PERSPECTIVE OF MINORITY
RESEARCHERS AND ALSO SUPPORT
THEM.
WE'VE HAD MANY LISTENING
SESSIONS LIKE MANY OTHER AT THE
NIH HAVE, BUT WHAT IS CLEAR
THERE ARE MANY THINGS, MANY
ACTIONABLE ITEMS WHERE WE CAN
ACTUALLY IMPLEMENT AND PROVIDE
RESOURCES AND FACILITATE AND
DIVERSIFY OR WORKPLACE.
AND THEN I DO WANT TO ADVERTISE
TO ALL OF YOU, I MEAN, WE'VE
BEEN TRYING TO OF COURSE
ADDRESSING STIGMA FOR
INDIVIDUALS WITH SUBSTANCE USE
DISORDER, WORSE DURING THE
PANDEMIC, MANY OF YOU BROUGHT IT
UP FROM COUNCIL.
IF YOU'RE SO SENSITIVE TO THE
ISSUE OF LANGUAGE, WE SHOULD USE
LANGUAGE THAT IS NOT
DISCRIMINATING, HOW COME, IF YOU
ARE SPEAKING THAT AND YOU'RE
BASICALLY AIMING TO CHANGE THE
CULTURE, HOW COME THE NATIONAL
INSTITUTE ON DRUG ABUSE STILL
USES "ABUSE" IF IT'S TITLE?
YES, NIDA REQUEST THE INSTITUTE
BE RENAMED NATIONAL INSTITUTE ON
DRUG AND ADDICTION, AND I'M
OPTIMISTIC IT WILL PASS AND
WE'LL HAVE A NEW NAME.
THANK YOU FOR YOUR ATTENTION.
I'M GOING TO STOP SHARING IN
CASE THERE ARE QUESTIONS THAT
ANY ONE OF YOU MAY HAVE.
>> NORA, YOU CAN GO TO 2:55.
WE'VE ASKED MIKE TO START THEN
SO YOU HAVE A FEW MORE MINUTES
FOR QUESTIONS.
>> I SEE A HAND RAISED.
>> GREAT DATA.
THANKS FOR SHARING.
I THINK THE NOTION OF LIKE
PRE-ADDICTION OR MAYBE BETTER
TITLING IT, PRE-USE DISORDER, I
THINK IT'S A GOOD CONCEPT IN
GENERAL.
THE ANALOGY TO PREDIABETES AND
INTERVENTION AROUND PREDIABETES,
THAT ALL MAKES SENSE.
HOWEVER, WHAT I'M SEEING OUT IN
THE MARKET RIGHT NOW IS THAT
PRIMARY CARE IS NOT REFERRING
PATIENTS TO TREATMENT.
IF PRIMARY CARE IS EVEN
SCREENING IN THE FIRST PLACE.
THERE'S A LOT OF DRIVERS BEHIND
THAT.
A LOT OF FRANKLY HAS TO DO WITH
STIGMA, THE OTHER PART PROBABLY
IS A PROCESS ISSUE.
I DON'T THINK THAT MODIFYING
DIAGNOSTIC CRITERIA IS GOING TO
MOVE THE NEEDLE A LOT.
THERE NEED TO BE MORE CARROT OR
MORE STICK, IF PAYERS, WHETHER
PUBLIC PAYERS OR COMMERCIAL
CARRIERS, TO CREATE THE
FINANCIAL PRESSURES OR
INCENTIVES ON PRIMARY CARE TO
SCREEN BUT ALSO TO REFER.
THE PLACES TO REFER ARE
INCREASINGLY BECOMING AVAILABLE.
ESPECIALLY FOR MILD AND MODERATE
USE DISORDERS.
YOU REFERENCE EVEN SOME OF THE
SBIR-FUNDED COMPANIES THAT CAN
BECOME AVAILABLE AS THE
RECIPIENTS OF THOSE REFERRALS.
BUT I'VE GOTTEN INVESTMENTS
ACROSS THREE DIFFERENT
COMPANIES, USE DISORDER SPACE,
ALSO I SENSE COMPANIES ALL THE
TIME RAISING CAPITAL, EVEN
COMPANIES WHOSE PRIMARY JOB IS
TO FACILITATE REFERRALS TO
SPECIALISTS, THEY ARE
STRUGGLING, REALLY STRUGGLING.
THE BETTER RESEARCH PRIORITY IS
PROBABLY CLARIFYING LIKE THE
ECONO-METRIC CONSIDERATIONS OR
STIGMAK OR PROVIDER CAPABILITY
CONSIDERATION AROUND SCREENING
AND REFERRALS, MAYBE BACKLOGGING
AROUND PRE-ADDICTION.
EVEN IF WE DO HAVE
PRE-ADDICTION, CHARACTERIZED AS
AN ICD-10 CODE, I DON'T SEE IT
MOVING THE NEEDLE MUCH.
>> I MEAN, I THINK THESE ARE --
THANKS FOR THE PERSPECTIVE.
MY VIEW OBVIOUSLY WE REALIZE
IT'S NOT GOING TO BE EASY AND
CHANGE IT, WHAT WE CAN DO IS
PROVIDE EVIDENCE.
WE DO HAVE DATA SHOWING HOW COST
EFFECTIVE IT IS TO PROVIDE FOR
TREATMENT BUT THAT'S NOT BEEN
ENOUGH.
THE QUESTION IS WHAT EXTRA DATA
DO WE NEED AND WHAT ARE POLICIES
THAT COULD HELP, JUST LIKE WE'RE
DISCUSSING BEFORE, OVERALL HOW
DO WE CHANGE A CULTURE OF
STIGMA, AND ONE OF THE IMPACTFUL
INTERVENTIONS, IF YOU GET
REIMBURSED, SUFFICIENTLY, THAT
INCENTIVIZES BECAUSE THAT'S WHAT
WE'VE DISCUSSED IN PAST
COUNCILS.
ONE OF THE REASONS WHY PEOPLE
ARE NOT TREATING INDIVIDUALS
WITH SUBSTANCE USE DISORDER,
REIMBURSEMENT IS TOO LOW.
WE NEED TO BRING IT UP.
IT WAS YOU WHO BROUGHT IT UP.
WE NEED TO BRING UP MORE
EQUITABLE TYPE OF REIMBURSEMENT
FOR SUBSTANCE USE DISORDER THAN
FOR OTHER MEDICAL CONDITIONS.
WE NEED TO MOVE ALL OF THE
ISSUES.
HOW DO WE MOVE THEM?
RIGHT NOW WHAT IS DIFFERENT, IF
WE CAN BRING FORWARD, THAT RIGHT
NOW WE'RE LIVING IN A PERIOD
WHERE USE OF ILLICIT DRUGS IS
VERY HIGH RISK, WE NEED TO FOCUS
ON PROTECTING THESE PEOPLE.
YOU NEED TO INCENTIVIZE THOSE
THAT ARE PROVIDING IT, YOU
INCENTIVIZE THEM BY PAYING THEM,
BY REIMBURSING THEM.
WHICH IS AGAIN WHAT HAPPENED IN
THE DIABETES.
HAS IT SOLVED THE PROBLEM?
NO, IT HAS NOT.
OF COURSE THERE ARE OTHER
ISSUES.
WHAT IT HAS DEFINITELY HELPED
SOME INDIVIDUALS ACTUALLY
PREVENT DIABETES.
I THINK I'M TRYING TO OBSERVE
WHAT SERIES OF COMBINATIONS OF
ACTIONS WILL MAKE A DIFFERENCE
AND ENGAGING THE HEALTH CARE
SYSTEM IN SOMETHING LIKE THIS
WILL ALSO HAVE ANOTHER ADVANTAGE
WHICH IS EDUCATE THEM.
EDUCATE THEM THAT THEY NEED TO
SCREEN.
EDUCATE THEM ABOUT SUBSTANCE USE
DISORDER.
SO THAT'S WHY -- BUT I THINK
YOU'RE ABSOLUTELY RIGHT, BY
ITSELF IT'S NOT GOING TO BE THE
DIFFERENCE.
BUT I SEE MANY OTHER HANDS
RAISED.
WHO WAS THE SECOND?
>> THANK YOU FOR THE BEAUTIFUL
PRESENTATION AND HIGHLIGHTING
SOME OF THE CRITICAL ASPECTS
THAT WE HAVE TO PAY ATTENTION
TO, IT WAS REALLY BEAUTIFUL.
I ALSO WANT TO GO BACK TO YOUR
PRE-ADDICTION CONCEPT.
I THINK IT'S ACTUALLY QUITE
USEFUL, AND I LOVE THE ANALOGY
TO PREDIABETES.
TWO THINGS MAYBE TO FOCUS ON,
ONE IS SCREENING.
THE FIRST ONE WHICH YOU
MENTIONED.
AND ANDREW MENTIONED AS WELL.
THEY DID START WITH ELECTRONIC
MEDICAL RECORDS, DID START
SCREENING FOR DEPRESSION.
A LOT OF PRIMARY CARE AND OTHER
SPECIALTIES ARE DOING THAT.
WE ASK ABOUT SMOKING, EMR, BUT
THAT'S WHERE IT STOPS.
WITH CANNABIS RATES AS HIGH,
ALCOHOL AND PAIN, THIS IS VERY
NOT ASKED, IT'S NOT SCREENED
FOR, AND WE HAVE VERY NICE
SCREENING TOOLS.
I THINK IT MIGHT BE REALLY TIME
TO IMPLEMENT SOME SORT OF MORE
WIDESPREAD SCREENING.
IT'S AN OPPORTUNITY TO EDUCATE,
HIGHLIGHTS AMONG PROVIDERS, THEN
THEY HAVE TO DO SOMETHING ABOUT
IT.
THEY HAVE TO BRING IT TO
ATTENTION.
SO, FOR EXAMPLE, NICOTINE AND
SMOKING SCREENING LED TO MORE
COLLABORATIVE CARE MODELS IN
CANCER, FOR EXAMPLE.
AND SO THIS WAITING FOR A
REFERRAL, WAITING FOR A PROVIDER
TO PAY ATTENTION, WHEREAS
COLLABORATIVE CARE IS INTEGRATED
MODELS, INTEGRATED BEHAVIORAL
HEALTH MODELS, AND THAT'S
SOMETHING FOLKS ARE TALKING
ABOUT AND I THINK IT MIGHT BE
REALLY USEFUL TO GAIN EVIDENCE
TO PROVIDE THE EVIDENCE TO
SUPPORT THOSE KIND OF MODELS.
>> AGAIN, I APOLOGIZE BECAUSE I
MAY HAVE MISSED THE ORDER.
SHELLY I THINK IS NEXT.
>> I THINK SO.
THANK YOU.
THANK YOU FOR THAT PRESENTATION
WHICH IS SO DATA RICH AND
ACTUALLY THERE'S SO MUCH TO
COMMENT ON.
SO I'M GOING TO TRY TO DO MY
BEST TO RESTRICT MY COMMENTS.
YOU CAN TIE A LOT OF WHATTIOU'RE
SCIENCE RESEARCH.
WE HAD OTHER CONVERSATIONS HERE
ABOUT THE NEED FOR MORE
IMPLEMENTATION SCIENCE RESEARCH.
WHAT I MEAN BY THAT IS WHETHER
WE'RE TALKING ABOUT SCREENING,
USE OF THE EMRs, WHAT YOU WERE
CALLING PRE-ADDICTION, ALSO
TALKING ABOUT INITIATION AND
RETENTION, FOR EXAMPLE,
MEDICATIONS FOR OPIOID USE
DISORDER.
MANY OF THOSE THINGS FALL IN
IMPLEMENTATION SCIENCE RESEARCH.
THE SECOND THING I WANT TO SAY,
AMONGST MY COLLEAGUES BOTH IN
ADDICTION AND PSYCHIATRY AND
ADDICTION MEDICINE, ALSO MY
COLLEAGUES IN THE CTN, WE TALK A
LOT ABOUT THE OBSTACLES ON THE
PROVIDER SIDE, ON THE PATIENT
SIDE.
ON THE PROVIDER SIDE ONE OF THE
PROBLEMS IS THAT IT IS COMPLEX
TO TAKE CARE OF PATIENTS WITH
SUBSTANCE USE DISORDERS AND
OPIOID USE DISORDER IN
PARTICULAR.
AND IT IS REALLY TOUGH FOR
PROVIDERS WITHOUT A CARE TEAM
AROUND THEM TO DO THAT.
TREAT ABOUT ONCOLOGIST TREATING
CANCER, ONCOLOGISTS WOULD BE
LOATHE TO PRESCRIBE CHEMOTHERAPY
WITHOUT HAVING AN ENTIRE CARE
TEAM AROUND THEM.
THAT'S A VERY BROAD CARE TEAM
USUALLY.
AND FOR PHYSICIANS IN
PARTICULAR, I WOULD SAY WHO ARE
PRESCRIBING MEDICATIONS AND
OTHER PRESCRIBERS HAVING A CARE
TEAM MAKES A DIFFERENCE TAKING
THE STEP FORWARD AND IT'S HARD
TO CHANGE OR INCENTIVIZE HEALTH
SYSTEMS TO PROVIDE THOSE TYPES
OF CARE TEAMS.
THAT'S THE FIRST PART OF IT.
I THINK SOME THINGS THAT RAJITA
WAS TALKING ABOUT, EMR PROMPTS,
ALSO THE ECONO-METRICS ANDRE WAS
TALKING ABOUT CAN BE LIKE
INTEGRATED INTO RESEARCH
PROPOSAL.
THEN YOU GO TO THE PATIENT SIDE.
WE KNOW PRESCRIBING OF THE
MEDICATIONS IS NOT ENOUGH FOR
THE PATIENTS.
PATIENTS ARE GENERALLY COMPLEX
AND REQUIRE OTHER TREATMENTS.
SOME OF THOSE, THERE ARE, YOU
KNOW, DEPEND ON WHERE ARE YOU IN
THE COUNTRY.
THEY DEPEND ON A HOST OF
FACTORS, A LOT OF SOCIAL
DETERMINANTS OF HEALTH.
BUT ALSO GENDER DIFFERENCES.
A LOT OF THESE PATIENTS WE SEE
HAVE OTHER CO-OCCURRING
SUBSTANCE USE DISORDERS AND
OTHER CO-OCCURRING MENTAL HEALTH
CONDITIONS.
A LOT MAKE IT HARDER ONCE THEY
ARE ON MEDICATIONS TO STAY ON
MEDICATIONS.
WE HAVE PATIENT FACTORS THAT
MAKES IT HARD OFTEN TO BE
RETAINED ON THE MEDICATIONS.
RESEARCH ON BOTH SIDES, PROVIDER
AND PATIENT, ARE REALLY
IMPORTANT.
AND PRE-ADDICTION, I THINK
THAT'S A REALLY IMPORTANT
CONCEPT.
ONE OF THE IMPORTANT CHANGES TO
DSM-V WAS FOR US TO BEGIN TO
TALK ABOUT MILD, MODERATE,
SEVERE SUBSTANCE USE DISORDERS
ACROSS THE SUBSTANCES.
AND THE REASON IT'S IMPORTANT IS
SO WE ACTUALLY CAN GET IN AND
INTERVENE SOONER LIKE WE DO WITH
EVERY OTHER MEDICAL CONDITION
UNDER THE SUN EXCEPT FOR
ADDICTION.
IT'S BEEN VERY HARD TO GET IN
AND START TO INTERVENE AS
DOCTORS AND OTHER PROVIDERS.
SO I THINK THAT'S A VERY
ON-TARGET SET OF IDEAS.
I'M NOT SURE I WOULD CALL THEM
PRE-ADDICTION, MAYBE EARLY
INTERVENTION.
WE COULD QUIBBLE OVER THE ACTUAL
WAYS IN WHICH WE MIGHT DISCUSS
IT BUT I THINK GETTING RIGHT IN
ON MILD TO MODERATE AND
BEGINNING TO TARGET
INTERVENTIONS IS REALLY
IMPORTANT.
THE OTHER THING I WANT TO SAY,
HIGH-RISK POPULATIONS, WHICH I
THINK YOU SHOWED US COMPELLING
DATA ACROSS GENDER AND RACIAL
AND ETHNIC MINORITY STATUS.
I WANT TO SAY IN ORDER FOR US TO
DRILL DOWN AS TO WHAT TYPES OF
INTERVENTIONS WE HAVE TO
REMEMBER THAT THERE'S A LOT OF
HETEROGENEITY WITHIN EACH OF
THOSE HIGH RISK POPULATIONS.
WE NEED TO KNOW WHERE ARE THEY
IN THE COUNTRY.
YOU KNOW, ARE THERE REGIONAL
DIFFERENCES?
URBAN, RURAL, THERE'S A WHOLE
BUNCH OF THINGS IN ORDER TO
BEGIN TO DRILL DOWN AS TO WHAT
THE APPROPRIATE INTERVENTIONS
WOULD BE AND WHAT THE MOST
EFFECTIVE INTERVENTIONS COULD
BE.
THOSE WERE JUST SOME OF MY
THOUGHTS ABOUT WHAT YOU'VE
HIGHLIGHTED ALL OF WHICH ARE
JUST INCREDIBLY IMPORTANT
CLINICALLY AND FROM A PUBLIC
HEALTH STANDPOINT, ALL OF WHICH
I REALLY BELIEVE WITH
IMPLEMENTATION SCIENCE THERE'S A
LOT WE COULD DISCOVER AND
UNDERSTAND ABOUT WHAT WOULD BE
MOST EFFECTIVE.
>> THANKS VERY MUCH.
WE HAVE GAIL AND MELISSA AND
JESS.
>> THERE WAS SO MUCH.
THANKS FOR THAT.
I REALLY CAN'T EMPHASIZE ENOUGH
THE OTHER INDIVIDUALS BEFORE ME,
BUT THERE ARE SO MANY CHALLENGES
USING THE WORD "PRE-ADDICTION,"
ET CETERA, LABELING THAT MIGHT
NEGATE ANYTHING WITH IDENTIFYING
THOSE PEOPLE.
WE NEED TO LEARN FROM THE
ALCOHOL LITERATURE, WE WERE
ABYSMAL ABOUT GETTING ANYONE
THAT WAS IN THE EARLIER STAGES
OF USE INTO TREATMENT BECAUSE NO
ONE WENT.
WE HAD SAMHSA MONEY, ALL KINDS
OF MONEY FROM EVERYWHERE.
AND BECAUSE PEOPLE DIDN'T FEEL
THAT IT WAS AN ISSUE FOR THEM
RIGHT NOW, IT WAS MILD, THEY
WEREN'T TAKING OFF WORK, THEY
WEREN'T GOING TO THESE SESSIONS,
ALMOST NOTHING HAPPENED.
SO I THINK WE HAVE TO BE CAREFUL
AROUND WHAT WE WOULD PROPOSE,
AND I ALSO AM A LITTLE NEGATIVE
IN THE WORD SCREENING.
I JUST WANT TO SAY THAT EACH
INSTITUTION, WHETHER IT'S E.D.
OR PRIMARY CARE, WE'RE SUPPOSED
TO SCREEN FOR 35 THINGS WHICH I
CAN'T SO I TRY TO USE THE WORD
IDENTIFY THROUGH A LOT OF WAYS
BECAUSE ONCE YOU GET TO
SCREENING YOU CAN NEVER GET PAST
IT.
EVERYBODY IS FIGHTING.
WHO IS SCREENING?
IS IT THE NURSE, P.A., THE
DOCTOR?
I'M DONE WITH THIS.
AND SO THE BEST AND EASIEST WAYS
IS SOMEHOW AS WE'RE DOING
EMBEDDING IT INTO EHR, SO ANYONE
COULD ACTUALLY SCREEN IN A
HEALTH CARE SYSTEM BUT I WOULD
TELL YOU THAT WE'RE NOT GOING TO
PICK UP THESE ADOLESCENTS IN
PRIMARY CARE.
THEY DON'T GO TO PRIMARY CARE,
ALL RIGHT?
SO, THEY ARE GOING TO BE IN THE
SCHOOLS ORS OR E.D.s.
IN THOSE AREAS, IT WOULD BE
GREAT TO HAVE SOME KIND OF
PREVENTION STRATEGIES THAT CAN
BE DONE THAT PEOPLE WOULD PICK
UP IN THE SCHOOL, A TEACHER
COULD HAVE, A PSYCHOLOGY
PSYCHOLOGIST OR SOME WAY TO
MEASURE FROM THAT POINT OF VIEW
OR IN AN ADOLESCENT EMERGENCY
DEPARTMENT OR SOMEWHERE THESE
INDIVIDUALS WOULD BE SEEN, AND
THEN COULD BE ADDRESSED BECAUSE
I DON'T THINK YOU'RE GOING TO
PICK THEM UP.
IT WOULD BE GREAT TO HAVE
BEHAVIORAL HEALTH INTEGRATED IN
THE SYSTEM.
IT'S ESSENTIAL CMS, I KNOW
THAT'S NOT OUR RESPONSIBILITY IN
RESEARCH BUT IT IS OUR
RESPONSIBILITY TO THINK ABOUT
THE MEASUREMENT TOOLS.
BUT CMS HAS GOT TO COME DOWN ON
THE FACT THAT IF YOU IDENTIFY
PEOPLE, IF YOU SEE PEOPLE, THAT
YOU HAVE TO DO THINGS.
WE HAVE ALL THESE NETWORKS OF
QUALITY IMPROVEMENT, AMERICAN
COLLEGE OF EMERGENCY PHYSICIAN
AND OTHERS, BUT WE'RE NOT
IDENTIFYING AND STRICT ONE,
ANYTHING RELATED TO USE IN
ADDICTION.
AN EXAMPLE IS IF YOU HAVE AN
ACUTE ELEVATION AND MISS TIME
POINTS WE'LL DISCUSSION FOR
HOURS ABOUT WHY EVERYBODY MISSED
IT AND WHAT'S THE OUTCOME.
WHEREAS IN AN OVERDOSE, FOR
EXAMPLE, WE DON'T HAVE THOSE
KINDS OF RESTRICTIONS AND THAT'S
BECAUSE CMS HAS TO ACTUALLY MAKE
IT A QUALITY MEASURE, NOT
SOMETHING YOU CAN PICK FROM BUR
A QUALITY MEASURE.
THE BEST WAY ARE PREDICTORS IN
THE I.T. SYSTEM.
IF YOU CAN GET PHENOTYPES
SOMEHOW IDENTIFIED IN SOME FORM
OF AN I.T. MECHANISM THAT IT
COMES OUT TO THE CLINICIAN,
WHETHER IN A PRIMARY CARE OR
E.D. SETTING, WHATEVER TOUCH
POINT, THAT WOULD BE GREAT.
SO RESEARCH INTO THAT AREA OF
IDENTIFYING PHENOTYPES, THEN
TRYING TO FIGURE OUT WHERE AND
WHAT WE WOULD DO NEXT WITH THEM
FOR PREVENTION WOULD BE GREAT
BUT I REALLY THINK IT NEEDS TO
BE IN THE SCHOOL OR E.D.
SETTINGS FIRST AND THE OTHER
LAST THING ABOUT ADOLESCENTS IS
I KNOW WE'VE BEEN HAVING TROUBLE
GETTING FUNDING FOR THINGS LIKE
BUPRENORPHINE IN YOUNG ADULTS.
IT'S CRAZY TO GET THAT ADOPTION
AND I'VE ACTUALLY SAID LET'S
FORGET IT.
I'VE BEEN WORKING WITH P-CARD TO
GET THAT IN AS EARLY PILOT, NOW
MAYBE WE HAVE TO DO
IMPLEMENTATION BECAUSE PEOPLE
ARE AFRAID TO INITIATE
MEDICATION WITH YOUNGER ADULTS.
THE OPTION IS IF THEY USE, THEY
DIE.
IT ISN'T LIKE ALCOHOL WHERE YOU
HAVE A LOT OF OPPORTUNITIES TO
INTERVENE.
AND WE NEED THEM TO BE PLACED ON
MEDICATION SO IF THEY ARE PLACED
ON MEDICATIONS THEY WILL BE
PROTECTED PARTICULARLY LIKE
BUPRENORPHINE.
SO, WE DEFINITELY NEED MORE -- I
GUESS NOW IMPLEMENTATION.
I WOULD HAVE SAID EFFICACY BUT
NO ONE WANTS TO FUND IT.
MAYBE THE IMPLICATION REALM OF
YOUNGER ADULTS GETTING INITIATED
ON BUPRENORPHINE, ALSO OBVIOUSLY
OTHER TREATMENTS THAT WOULD HAVE
TO BE SURROUNDING THAT.
ANYWAY, I'LL BE QUIET NOW.
THANKS.
>> THANKS VERY MUCH, GAIL.
I AGREE, BASICALLY INVOLVEMENT
OF ENGAGEMENT TO PRIMARY CARE
WAS PREDOMINANTLY IN ADULTS, THE
EASIEST TO TRY TO TACKLE.
ADOLESCENTS IS MORE COMPLEX AND
WE DON'T HAVE NECESSARILY THE
KNOWLEDGE BASE.
IT DOESN'T MEAN WE DON'T BUT I
AGREE THERE ARE OTHER
INTERVENTIONS THAT MAY BE PLACES
TO DO IT THAT ARE MORE RELEVANT
THAN PRIMARY CARE.
I SEE MELISSA HAS HAD HER HAND
RAISED.
>> NORA, WE HAVE THREE MORE
QUESTIONS AND MIKE IS HERE.
WE'VE ALREADY POSTPONED HIM FOR
TEN MINUTES SO WE SHOULD TRY TO
GO QUICKLY IF WE'RE GOING TO
HAVE PEOPLE SPEAK.
>> THANKS FOR REMINDING ME OF
THE TIME THAT'S PASSING.
MELISSA?
I.
>> BE SUPER BRIEF.
ONE, PRE-ADDICTION TO PREVENTION
COMMUNITY, INTERVENTION, AND
HARM REDUCTION I HEAR MOVING THE
NEEDLE ON WHAT CONSTITUTES RISKY
SUBSTANCE USE, AS A PARENT
SOMETHING I'M TERRIFIED ABOUT.
WE KNOW THEY ARE GOING TO DABBLE
AND TRY THINGS.
THAT DOESN'T -- TODAY'S
GENERATION, IT ISN'T THE SAME
THINGS WE HAD IN OUR PRIOR
GENERATIONS.
THIS IDEA, I AGREE WITH THE
OTHERS, MAYBE NOT CALLING IT
PRE-ADDICTION BUT MOVING THE
NEEDLE FOR COMMUNITY OUTREACH
PREVENTION AND INTERVENTION AND
NORMALIZING HARM REDUCTION MAKES
ME EXCITED.
SECOND QUICK THING, THE DATA,
INCREASES IS HEARTBREAKING.
TERRIFYING.
FOR SO MANY REASONS.
THE FACT THAT NIDA IS GETTING
MORE RESOURCES IS GREAT, I'M
WONDERING NIH-WIDE HOW THIS
TRANSLATES INTO HOW MONEY
TRICKLES DOWN TO INDIVIDUAL
INVESTIGATORS, AS WE KNOW
INFLATION IS KILLING A LOT OF
STUDIES IN TERMS OF STAFFING,
EQUIPMENT, COST TO RUN A STUDY,
BUT OUR BUDGETS ARE THE SAME.
MAYBE FOR LATER CONVERSATION.
>> THANKS.
IT'S IMPORTANT AND WE'LL LOOK
INTO IT.
I'M RESTRICTED IN TIME.
JESS, YOUR HAND IS RAISED.
>> I'LL BE QUICK TOO.
TIME IS SHORT.
ON THE PRE-ADDICTION PIECE,
WHATEVER YOU CALL IT, I WANT TO
ECHO WHAT SHELLY SAID AND HOW
IMPORTANT IT IS TO HAVE THIS
CONVERSATION.
I THINK TO THE ADD ANOTHER
ELEMENT TO IT, IT'S NOT JUST
ABOUT THE SCREENING PIECE, WHAT
HAPPENS IN HEALTH CARE.
IT'S ABOUT EMPOWERING PATIENTS
WITH INFORMATION AND HOW THEY
PROTECT THEIR OWN HEALTH.
AND AT ADDICTION POLICY FORUM,
MAYBE YOU WOULDN'T BE SURPRISED,
BUT THERE'S SO LITTLE LITERACY
OUT IN COMMUNITIES ABOUT WHAT
CONSTITUTES A MILD SUBSTANCE USE
DISORDER, WHAT ARE THE SYMPTOMS
TO BE ON THE LOOKOUT FOR FOR
YOURSELF OR SOMEONE YOU CARE
ABOUT.
I THINK INVESTING AND INCREASING
LITERACY AND HOW WE CAN ENGAGE
SOMEONE SOONER GOING BACK TO
SHELLY'S COMMENT, THE ONLY
ILLNESS WE WAIT FOR IT TO GET
WORSE BEFORE WE INTERVENE SO
DOUBLING ON CHANGING THAT IS AN
IMPORTANT TOPIC.
THE OTHER THING, IT'S ABOUT ALSO
USING MOMENTS FOR HARM
REDUCTION.
SO RISKY SUBSTANCE USE, WE CAN
ENGAGE IN EDUCATING THAT
PATIENT, TALKING ABOUT HARM
REDUCTION STRATEGIES, THAT'S A
REALLY IMPORTANT SORT OF POINT
ESPECIALLY SINCE WE HAVE SOME
HARM REDUCTIONS THAT ARE
CULTURAL WHEN IT COMES TO
ALCOHOL USE BUT HAVE NOT BUILT
THOSE STRATEGIES WHEN IT COMES
TO MARIJUANA USE OR
BENZODIAZEPINE.
I THINK THE THE TIME IS NOW AND
THIS IS CRITICAL.
ANOTHER THING TO MENTION ON YOUR
UPDATES AROUND MOUD, ONE OF OUR
MOST -- BIGGEST CONCERNS,
AMAZING INTERVENTIONS ARE NOT
UTILIZED, TRANSLATING THIS AND
MAKING SURE MORE HEALTH CARE
PROVIDERS ARE AWARE OF THAT, WE
JUST LOST A VOLUNTEER AND TEAM
MEMBER, SOMEONE WE WORK WITH,
STABLE ON BUPRENORPHINE FOR OVER
A DECADE AND IT WAS THIS PRIMARY
CARE PHYSICIAN WHO FORCED HIM
OFF THE MEDICATION.
I THINK THAT YOUR TALK, NORA, IN
THE HANDS AND IN FRONT OF AS
MANY HEALTH CARE PROVIDERS AND
THOSE THAT ARE SEEING PATIENTS
DAILY IS CRITICAL.
>> ANNA ROSE?
>> VERY FAST, TO SAY WE'RE AT
THIS EXTRAORDINARY POINT IN THE
NEXT FEW YEARS FROM ABCD AND
SIMILAR STUDIES MORE KNOWLEDGE
THAN WE'VE EVER HAD WHAT
PREDICTORS ARE AND WANT POLICY
AND IMPLEMENTATION ISSUES VERY
REAL BUT WE WANT THAT KNOWLEDGE
TO MEAN SOMETHING.
SO THAT BASICALLY WE CAN GO
EARLIER AND EARLIER AND WE
ACTUALLY HOPEFULLY DON'T HAVE TO
WAIT EVEN POTENTIALLY FOR
HARMFUL USE TO IDENTIFY PEOPLE
AT RISK BECAUSE WE'LL HAVE
PHENOTYPES TO MAKE USE OF BEFORE
THE BRAIN IS ADDITIONALLY
CHANGED BY THE SUBSTANCE
EXPOSURE.
SO EVEN THOUGH ALL OF THESE
THINGS ARE DIFFICULT, WE WANT TO
MAKE THAT INFORMATION IMPORTANT
AND USEFUL.
>> VERY GOOD POINTS.
I APOLOGIZE FOR NOT HAVING MORE
TIME FOR DISCUSSION.
ALL THESE POINTS YOU BROUGHT UP
ARE CRUCIAL.
BUT TIME HAS PASSED BY.
MOVE, NORA, MOVE.
I GIVE IT BACK TO YOU.
I'M SORRY FOR TAKING LONGER.
>> THAT'S OKAY.
I WANT TO INTRODUCE MIKE LAUER
QUICKLY.
HE WILL TALK ABOUT
IMPLEMENTATION OF THE NIH DATA
MANAGEMENT AND SHARING POLICY.
HE'S DEPUTY DIRECTOR FOR
EXTRAMURAL RESEARCH WHERE HE
SERVES AS PRINCIPAL SCIENTIFIC
LEADER AND ADVISER TO THE NIH
DIRECTOR ON THE NIH EXTRAMURAL
RESEARCH PROGRAM.
MIKE?
>> GREAT, SUSAN.
THANK YOU VERY MUCH.
GOOD AFTERNOON, EVERYBODY.
I WILL ATTEMPT TO SHARE MY
SCREEN.
>> THAT'S WORKING.
>> OKAY, GOOD.
ALL RIGHT.
SO, I WANT TO GIVE PARTICULAR
THANKS TO A NUMBER OF MIGHT HAVE
COLLEAGUES INCLUDING LYRIC
JORGENSON, ACTING DIRECTOR OF
OFFICE OF SCIENCE POLICY, AND
COLLEAGUES INCLUDING CINDY
DANIELSON, JULIA.
WHEN JOE BIDEN WAS VICE
PRESIDENT THERE WAS A HIGH
PRIORITY AREA.
IN 2016 THE 21ST CENTURY CURES
CURES WAS PASSED, INCLUDING
PROVISION THAT GAVE NIH DIRECTOR
AUTHORITY TO REQUIRE RECIPIENTS
OF NIH AWARDS TO SHARE
SCIENTIFIC DATA TO THE EXTENT
FEASIBLE GENERATED FROM NIH
AWARDS.
DATA SHARING POLICIES ARE NOT
KNEW.
IN 2003 WE ISSUED THE MAIN
POLICY, STILL EFFECTIVE TODAY,
APPLIES TO ALL AWARDS OVER
$500,000 A YEAR IN DIRECT COSTS.
IN 2014 WE ISSUED THE MORE
RECENT VERSION OF THE GENOMIC
DATA SHARING POLICY.
IN 2016 WE ISSUED A POLICY
REQUIRING REGISTRATION AND
REPORTING OF CLINICAL TRIALS
FUNDED BY NIH.
AND THERE HAVE BEEN A NUMBER OF
OTHER DATA SHARING POLICIES THAT
HAVE BEEN IMPLEMENTED BY
I.C.s, OR FOR SPECIFIC
PROGRAMS, PERHAPS MOST NOTABLY
THE CANCER MOONSHOT.
THE CURRENT POLICY HAS BEEN A
LONG TIME IN COMING, OSP GETS
THE PRIMARY CREDIT FOR
SHEPHERDING THIS THROUGH.
THERE WERE VARIOUS ITERATIONS
THAT WERE PUT OUT FOR PUBLIC
COMMENT, AT VARIOUS POINTS,
ALONG THE WAY BUT IN A WAY YOU
CAN SEE THIS START IN 2016 WITH
THE 21ST CENTURY CURES ACT.
IN OCTOBER OF 2020, THE POLICY
AND GUIDANCE WAS RELEASED, WITH
THE IDEA IT WOULD BECOME
EFFECTIVE FOR APPLICATIONS
COMING IN, IN JANUARY OF 2023.
THIS ALLOWED A FAIRLY LONG
PERIOD OF TIME TO GO BY TO
ENABLE THE AGENCY TO GET READY
FOR THE IMPLEMENTATION AND ALSO
FOR EXTRAMURAL COMMUNITY TO GET
PREPARED.
THERE HAVE BEEN MULTIPLE
CONSULTATIONS IN THE GOVERNMENT
AND OUTSIDE THE GOVERNMENT AS
THIS HAS MOVED ALONG.
VERY BRIEFLY THIS IS WHAT THE
POLICY IS.
THERE ARE TWO REQUIREMENTS.
ONE REQUIREMENT IS THAT WHEN AN
APPLICATION IS SUBMITTED, THERE
HAS TO BE A DATA MANAGEMENT AND
SHARING PLAN.
THIS IS FOR ALL NIH-FUNDED
RESEARCH THAT WILL GENERATE
DATA, PRESUMABLY THAT'S THE VAST
MAJORITY OF NIH-FUNDED DATA,
NIH-FUNDED RESEARCH WORLD
GENERATES DATA.
NOW, AN IMPORTANT PART OF THIS
IS THAT THE POLICY DOES NOT SAY
THAT DATA SHARING HAS TO OCCUR
IN A VERY SPECIFIC WAY.
THIS IS BECAUSE OF THE BREADTH
OF SCIENCE
HOW ONE WOULD SHARE DATA FOR
PHASE 3 OR PHASE 4 CLINICAL
TRIAL MAY BE VERY DIFFERENT FROM
ONE OF HOW ONE MIGHT SHARE DATA
FOR A BASIC SCIENCE STUDY.
AND SO THE IDEA IS THAT
RESEARCHERS AND GRANT
APPLICATION ORGANIZATIONS WILL
PROPOSE A DATA MANAGEMENT AND
SHARING PLAN, AND THEN WE WILL
WORK WITH THEM TO APPROVE IT OR
REVISE IT AS NEED BE.
SO THE FIRST REQUIREMENT THERE
HAS TO BE A SUBMISSION OF DATA
MANAGEMENT SHARING PLAN.
THE SECOND REQUIREMENT IS THAT
ONCE IN A PLAN IS AGREED TO,
THAT THE GRANT RECIPIENT NEEDS
TO COMPLY WITH THAT PLAN.
THAT DOES NOT IN ANY WAY PREVENT
REVISIONS OF A PLAN AS ONE MOVES
ALONG.
THIS IS' EFFECTIVE FOR
APPLICATIONS JANUARY 25, 2023
AND LATER.
THAT'S THE POLICY.
THE EXPECTATIONS ARE THAT DATA
SHARING SHOULD BE THE DEFAULT
AND DATA SHARING SHOULD BE
MAXIMIZED WITH JUSTIFIABLE
LIMITS FOR TECHNICAL, ETHICAL,
LEGAL FACTORS, SHOULD BE
RESPONSIVELY IMPLEMENTED WITH
APPROPRIATE PROTECTION OF
PRIVACY RIGHTS AND
CONFIDENTIALITY, ALSO ABIDING BY
EXISTING LAWS, REGULATIONS,
POLICIES, AND SHOULD BE
PROSPECTIVELY PLANNED.
THIS IS HOW WE THINK THIS IS
GOING TO LOOK.
THIS IS NOT ABSOLUTELY FINAL BUT
I THINK WHAT IS GOING TO BE
ABSOLUTELY FINAL WILL BE VERY
CLOSE TO THIS.
THE IDEA IS THAT THE PLAN IS
SUBMITTED WITH THE APPLICATION,
TWO PARTS.
A BRIEF DESCRIPTION OF THE PLAN.
WE UNDERSTAND SHARING DATA,
MAPPING DATA AND SHARING DATA
ENTAILS COST AND DIRECT COSTS TO
THE GRANT.
THAT WOULD BE INCLUDED WITHIN
THE BUDGET JUSTIFICATION OF THE
APPLICATION.
THAT'S SOMETHING THAT PEER
REVIEWERS WILL SEE.
THE FULL PLAN WILL BE SEPARATE
ATTACHMENT, THAT'S SOMETHING
THAT WE'RE NOT ASKING PEER
REVIEW TO DO BECAUSE THIS IS AN
ADMINISTRATIVE MATTER, SOMETHING
THAT PROGRAM STAFF WILL ASSESS,
WE ARE PROVIDING OUR PROGRAM
STAFF AND WE'RE GOING TO BE
DOING THIS QUITE INTENSIVELY
OVER THE NEXT FEW MONTHS OR SO
WITH VARIOUS TOOLS TO HELP THEM
WITH THESE ASSESSMENTS.
IF THE PLAN IS APPROVED THEN
THAT WOULD THEN BECOME PART OF
THE TERMS AND CONDITIONS OF AN
AWARD.
THE PLANS CAN BE REVISED, AS
NEED BE, AS TIME GOES ON.
WE UNDERSTAND THAT MAY ALL
HAPPEN.
ONE OF THE BIG QUESTIONS, WHAT
IS DATA?
WE DEFINE DATA, AND THESE CAN BE
PUBLISHED OR UNPUBLISHED, DATA
SHOULD BE MADE AVAILABLE AT THE
TIME OF PUBLICATION OR WHEN THE
AWARD COMES TO AN END.
NOW, WE'RE NOT ASKING FOR LAB
NOTEBOOKS, PRELIMINARY ANALYSES,
ORIGINAL CASE REPORT FORMS, OR
PHYSICAL OBJECTS.
I WILL MENTION THAT, THIS HAS
BEEN TRUE FOR A LONG TIME, THE
AGENCY HAS THE RIGHT TO ASK FOR
ORIGINAL DATA UNDER CERTAIN
SPECIFIC CIRCUMSTANCES.
BUT THAT'S NOT WHAT WE'RE
TALKING ABOUT HERE.
AND SO THIS IS NOT -- THESE
ITEMS LIKE THE LAB NOTEBOOKS ARE
NOT IN PLAY.
WHAT'S HAPPENING?
WHAT IS HAPPENING IS WE'RE
ADDRESSING COUNCILS, AND SO
DOING THAT NOW.
WE'RE GOING TO BE DOING MORE OF
THAT OVER THE NEXT FEW WEEKS.
WE'LL ALSO BE ADDRESSING
COUNCILS IN THE FALL.
WE HAVE PUT OUT -- WE'LL HAVE
WEBINARS, WEBINARS ARE BEING
SCHEDULED, PUTTING OUT FAQs,
IN JANUARY WE PUT OUT DRAFT
GUIDANCE FOR RESEARCHERS WHO ARE
WORKING WITH NATIVE AMERICANS,
AND THAT WAS AN RFI THAT WE'RE
CURRENTLY WORK ON WITH DREW.
THERE'S ALREADY BEEN
COMMUNICATION OF WHAT'S GOING ON
BUT IT'S GOING TO BUILD UP OVER
THE NEXT FEW MONTHS.
ONE THING WE'RE WORKING ON ARE
SAMPLE PLANS.
WRITING UP SAMPLE PLANS.
BY THE WAY, WE DO KNOW THERE ARE
EXTERNAL ORGANIZATIONS THAT HAVE
PUT OUT SAMPLE PLANS.
AND SOME OF THEM ARE REALLY
QUITE GOOD.
WE WILL DO THAT.
SOME PEOPLE MAY BE WONDERING
ABOUT THE GENOME DATA SHARING
POLICY.
SO IF ONE IS SHARING GENOMIC
DATA, WE'RE NOT ASKING FOR TWO
PLANS.
ONE REGULAR PLAN AND ONE GENOMIC
PLAN.
SO THERE WILL ONLY BE ONE PLAN.
SO THAT'S ANOTHER THING WE'RE
WORKING ON.
AND THEN OBVIOUSLY AS TIME GOES
ON WE WILL EVALUATE THIS TO SEE
WHETHER OR NOT IT'S WORKING.
ONE THEME WE OFTEN HEAR IS ABOUT
MAKING IT A POSITIVE THING TO
SHARE DATA.
INCENTIVIZING RESEARCHERS TO
SHARE DATA AS THEY HAVE BEEN
INCENTIVIZED TO PUBLISH RESULTS
OF THEIR WORK.
I'D LIKE TO POINT YOU TO OUR NEW
WEBSITE.
THIS IS BRAND NEW.
WE JUST RELEASED IT A FEW WEEKS
AGO.
IT'S GOT A CATCHY URL,
SHARING.NIH.GOV.
WHAT WE'RE ATTEMPTING TO DO HERE
IS PUT INTO ONE PLACE IN A
RELATIVELY USER FRIENDLY WAY
INFORMATION ABOUT OUR DATA
MANAGEMENT AND SHARING POLICY,
ABOUT THE GENOMIC DATA SHARING
POLICY WHICH OF COURSE HAS BEEN
AROUND FOR A WHILE, OTHER
SHARING POLICIES, WE ALSO HAVE
INFORMATION FOR PEOPLE WHO ARE
INTERESTED IN ACCESSING DATA,
USING IT, AND WE ALSO HAVE A
VARIETY OF INFORMATION ABOUT
OTHER THINGS.
RESOURCES AND EVENTS THAT ARE
GOING TO BE COMING UP.
ONE CAN EXPLORE A VARIETY OF
AREAS, SCIENTIFIC DATA, WHICH IS
OBVIOUSLY WHAT WE'RE TALKING
ABOUT RIGHT NOW.
GENOMIC DATA, POLICIES WILL
RESEARCH TOOLS, POLICIES ABOUT
MODEL ORGANISMS, AND CLINICAL
TRIALS.
AND ALSO THE PUBLIC ACCESS
POLICY.
THERE'S ALSO A DECISION TOOL,
WHERE YOU CAN CLICK THIS BUTTON
ON THE BOTTOM, FIND WHICH
POLICIES APPLY TO YOU, AND WE'LL
ASK A SERIES OF QUESTIONS WHERE
YOU CAN FIGURE OUT WHAT YOU NEED
TO PAY ATTENTION TO.
WE HAVE SECTIONS IN HERE ABOUT
WRITING A DATA MANAGEMENT AND
SHARING PLAN.
AND I'LL POINT OUT WHEN THE
POLICY CAME OUT BACK IN 2020
THERE WERE A NUMBER OF
SUPPLEMENTAL DOCUMENTS THAT WERE
ALSO PUBLISHED IN THE NIH GUIDE,
ABOUT WHAT ARE THE EXPECTED
ELEMENTS IN A DATA MANAGEMENT
SHARING PLAN, WHAT TYPE OF
THINGS CAN ONE BUDGET FOR, AND
THERE'S BEEN A LOT OF WORK
THAT'S HAPPENING ON THIS SINCE
THEN.
SELECTING A DATA REPOSITORY.
WHAT ARE THE CHARACTERISTICS OF
A REPOSITORY, THAT ONE SHOULD
LOOK FOR.
WE KNOW IN SOME CASES I.C.s
HAVE THEIR OWN POLICIES ABOUT
REPOSITORIES.
SOME SAY IF YOU'RE FUNDED BY US
YOU HAVE TO USE OUR REPOSITORY.
WE ALSO KNOW THAT A NUMBER OF
INSTITUTIONS AND PARTICULAR
INSTITUTIONAL LIBRARIES HAVE
REPOSITORIES OR ARE SETTING UP
REPOSITORIES.
WHICH ARE REALLY GOOD.
THAT MIGHT BE ANOTHER POSSIBLE
AVENUE.
OKAY.
WHAT ARE WE HEARING?
SO, WE'RE HEARING ON THE ONE
HAND THAT IT'S TOO AMBIGUOUS.
WE'RE HEARING ON THE OTHER HAND
THAT IT'S TOO PRESCRIBED.
I GUESS THERE'S NO WAY ONE CAN
AVOID THIS KIND OF THING.
SO SOME OF THE QUESTIONS ARE
WHAT EXACTLY IS SCIENTIFIC DATA?
WE TALKED ABOUT OUR DEFINITION
OF IT BUT STILL ONE CAN
UNDERSTAND THAT ONE IS DEALING
WITH SPECIFIC CASES THERE MAY BE
SOME GRAY ZONES.
WHERE SHOULD THE DATA BE SHARED?
SO THIS IS PART OF THE REASON
WE'RE GIVING AS MUCH INFORMATION
AS WE CAN ABOUT REPOSITORIES.
WE GIVE INFORMATION ABOUT
REPOSITORIES IN EXISTENCE, NOT
ONLY NIH BUT SOME GENERAL
REPOSITORIES THAT ARE OUT THERE
THAT ARE COMMONLY USED.
WHAT ABOUT I.C.s SPECIFIC DATA
SHARING POLICIES AND HOW DOES
THAT WORK?
NEXT QUESTION IS WHERE IS THE
MONEY COMING FROM?
WE RECOGNIZE THIS IS NOT FREE.
MANAGING AND SHARING DATA DOES
ENTAIL COSTS, PART OF THE REASON
WE DECIDED WE WOULD HIGHLIGHT
THIS, AND THE BUDGET
JUSTIFICATION, BECAUSE WE WANT
RESEARCHERS AND INSTITUTIONS TO
THINK HARD ABOUT THE KIND OF
MONEY THAT MAY BE NECESSARY TO
SUPPORT THIS KIND OF WORK.
WE ALSO -- NATIONAL LIBRARY OF
MEDICINE COMMISSION THE NATIONAL
ACADEMIES TO DO A STUDY ON THE
COST OF DATA SHARING.
AND THERE'S TOOLS PUT TOGETHER.
THIS IS SOMETHING WHICH IS
AVAILABLE THROUGH OUR WEBSITE.
WILL THE PLANS BE PUBLIC IS
ANOTHER QUESTION THAT WE'RE
HEARING.
THE ANSWER IS YES.
WE WILL BE POSTING THE DATA
SHARING PLANS, PROBABLY ON THE
QUARTER, EXACTLY HOW THAT'S
GOING TO LOOK IS SOMETHING WE'RE
STILL WORKING ON.
HOW WILL NIH ENFORCE COMPLIANCE?
JUST LIKE WE ENFORCE ANY OTHER
TERM AND CONDITION OF AWARD.
WE SUSPECT THERE'S GOING TO BE A
FAIR AMOUNT OF SELF-REGULATION
WITHIN THE COMMUNITY BECAUSE I
WILL TELL YOU THAT -- I'VE BEEN
AT NIH FOR 15 YEARS.
AT LEAST ONCE A MONTH OR ONCE
EVERY TWO MONTHS I GET AN E-MAIL
FROM SOMEBODY WHO SAYS YOU'RE
AGENCY PUBLISHED A STUDY ABOUT
X, Y,Z, NOBODY IS WILLING TO
SHARE THE DATA WITH ME.
AND UP UNTIL NOW THERE'S NOT
MUCH WE COULD DO ABOUT THAT.
BUT WE SUSPECT THAT THAT KIND OF
THING HAPPENS, WE MAY HEAR ABOUT
IT.
SO, LET ME CLOSE BY SAYING THAT
DATA SHARING HAS LONG BEEN
EXPECTED.
THERE'S NOTHING NEW HERE.
BUT WHAT IS NEW HERE IS THAT
WE'RE RAISING THE LEVEL, EXTENT,
AND DEPTH OF DATA SHARING,
MAKING THIS PART OF EVERY NIH
AWARD, ASKING RESEARCHERS AND
THEIR INSTITUTIONS TO
PROSPECTIVELY PLAN DATA
MANAGEMENT AND SHARING FROM THE
GET-GO.
THE IMPLEMENTATION WILL BEGIN IN
JANUARY OF 2023.
WE ANTICIPATE LIKE WITH ANYTHING
THAT'S NEW THAT WE WILL LEARN A
LOT AS THIS IS MOVING ALONG AND
SO WE'RE ALMOST CERTAIN THERE
WILL BE IMPROVEMENT AND
REFINEMENTS THAT WILL BE MADE
OVER TIME.
THE PRIMARY REQUIREMENT IS THAT
WE NEED TO SEE A DATA MANAGEMENT
AND SHARING PLAN, AND THAT ONCE
THAT PLAN IS AGREED UPON THAT
THERE'S COMPLIANCE WITH THE PLAN
AND THE KEY ELEMENTS THAT ARE IN
THERE, ALTHOUGH THERE'S A LOT,
IF YOU GO INTO THE WEBSITE OR GO
INTO THE ORIGINAL DOCUMENTS THAT
WERE PUBLISHED IN 2020 ARE HOW
WILL THE DATA BE MANAGED, WHAT
WILL THE DATA BE SHARED, AND HOW
MUCH WILL IT COST.
AND WHAT WILL THE BUDGETING BE.
PLEASE PAY ATTENTION TO THE
WEBSITE.
PLEASE ADVERTISE OUR WEBSITE.
AND IN THE WEBSITE WE DO HAVE A
NEWS ITEMS, THINGS COMING UP
SUCH AS WEBINARS, NEW FAQs
BEING POSTED.
AS WE GET FAQs WE'RE THINKING
ABOUT THEM AND THEN POSTING
THEM.
WE HOPE YOU FIND THE WEBSITE
HELPFUL.
AND IF THERE'S INFORMATION THERE
THAT YOU THINK IS CONFUSING OR
MISSING, OR COULD BE BETTER
PRESENTED, PLEASE LET US KNOW.
AND WE WILL CONTINUE TO WORK ON
THAT.
SO, I HOPE YOU FOUND THIS
INTERESTING AND THERE SHOULD BE
TIME FOR COMMENTS OR QUESTIONS.
>> THANKS VERY MUCH.
NOW WE'RE OPENING TO COUNCIL
MEMBERS, IF THERE ARE QUESTIONS
OR COMMENTS.
PLEASE RAISE YOUR HAND.
>> MELISSA HAS SOMETHING IN THE
CHAT, WHICH IS PROBABLY WORTH
RAISING BECAUSE THE PEOPLE ON
VIDEOCAST CAN'T READ THE CHAT.
>> OH, SURE.
THANKS FOR CALLING IT OUT.
I WAS CURIOUS, TWO THINGS.
ONE, IN THE PUBLIC COMMENT
PEOPLE ARE ASKING YOU ABOUT
QUALITY, DATA QUALITY, DATA
MANAGEMENT QUALITY, BECAUSE AS
WE ALL KNOW WHEN YOU START
WORKING WITH A NEW TEAM AND SEE
HOW THEY CODE DATA OR DON'T HAVE
A CODE BOOK IT'S DIFFICULT TO
WORK WITH THAT DATA AND IMPACTS
CONCLUSIONS DRAW.
THAT'S ONE.
AND I CAN'T HELP BUT NOTE YOU
MENTIONED AMERICAN INDIAN
CONTEXT, WHERE MY EXPERTISE IS.
LOTS OF WORK AROUND DATA
SOVEREIGNTY.
RESEARCHERS WHO WANT TO ACCESS
WILL HAVE TO PROBABLY GO ONE BY
ONE IN FRONT OF TRIBAL COUNCIL
TO REQUEST IT, ANOTHER LABORIOUS
PROCESS.
>> BOTH EXCELLENT COMMENTS.
YES, WE'VE HEARD A LOT ABOUT
DATA MANAGEMENT, DATA QUALITY
AND DATA MANAGEMENT QUALITY.
SOME DATA MAY NOT BE WHAT WE'VE
HEARD, SOME DATA IS NOT WORTH
SHARING.
I THINK ONE THING THAT IS
INTERESTING THAT WE THOUGHT
ABOUT, I SHOULDN'T SAY THERE'S
NOTHING ORIGINAL HERE, THESE ARE
IDEAS WE'VE HEARD FROM
ELSEWHERE, WHEN SCIENTISTS ARE
ASKED TO SHARE THEIR DATA AND
SHARE THEIR METHODS MORE
EXPLICITLY, SHARE THEIR CODE,
THAT THAT MAY INCENTIVIZE THEM
TO BE A BIT MORE CAREFUL.
I KNOW THIS MYSELF BECAUSE I'VE
DONE -- MY BACKGROUND IS
CARDIOVASCULAR EPIDEMIOLOGY, AND
I'VE ALWAYS WORKED IN A PLACE
WHERE I KNEW OTHER PEOPLE WERE
LOOKING AT MY STUFF BECAUSE
THAT'S HOW IT WAS BUILT IN.
PEOPLE WOULD BE LOOKING AT MY
CODE OR LOOKING AT THE TABLES.
AND I THINK THAT DOES CREATE
INCENTIVE TO SAY, OKAY, LET'S
MAKE SURE THAT THERE ARE NO
STUPID MISTAKES HERE.
LET'S ALSO MAKE SURE THAT THINGS
ARE WELL ANNOTATED SO THAT
PEOPLE UNDERSTAND WHAT WE'RE
DOING.
IT'S A REALLY GOOD POINT.
THAT'S SOMETHING WE'RE GOING TO
BE FOLLOWING CLOSELY.
>> ANY OTHER QUESTIONS?
YES, INDEED, BUT I DON'T KNOW
WHO WAS FIRST, SHARON OR
LAKSHMI.
>> VERY IMPORTANT.
MY QUESTION IS TO DO WITH
WHETHER YOU'RE CONSIDERING
HANDS-ON TRAINING SESSIONS ON
DATA MANAGEMENT.
YOU'RE DOING WEBINARS, AS YOU
ACCUMULATE MORE QUESTIONS THAT
ARE COMING FROM THE LARGER BODY
OF SCIENTIST.
IT MIGHT BE WORTHWHILE SETTING
UP SOME TRAINING SESSIONS ON HOW
TO MANAGE DATA, ANALYZE, AND
THEN HOW TO SHARE DATA.
MIGHT BE SOMETHING THAT MIGHT BE
WORTHWHILE ESPECIALLY IN THIS
AGE OF PROBLEMS WITH
REPRODUCIBILITY.
>> THAT'S VERY INTERESTING.
THERE ARE VARIOUS LEVELS.
ONE IS WHAT EXACTLY IS IT THAT
NIH IS ASKING FOR?
WHAT DO YOU NEED TO DO TO MEET
THE NIH EXPECTATIONS?
BUT I THINK YOU'RE TAKING THIS
TO AN EVEN HIGHER OR DEEPER
LEVEL, TO SAY, OKAY, WHAT DO YOU
DO -- MELISSA'S QUESTION, WHAT
DO DO YOU TO DO THIS WELL?
AND WHAT WHAT'S THE RIGHT WAY OF
DOING THIS?
WHEN WE PUT OUT THE RIGOR POLICY
IN 2015-2016, WE DID PUT OUT
SOME FUNDING OPPORTUNITIES FOR
TRAINING MODULES AND THERE ARE
TRAINING MODULES THAT ARE OUT
THERE, ON SCIENTIFIC RIGOR.
BUT THAT'S A REALLY INTERESTING
IDEA.
THAT'S SOMETHING WE'LL TAKE
BACK.
THANK YOU.
>> SHARON?
>> THANK YOU, NORA.
THANK YOU FOR THAT PRESENTATION.
I THINK THIS IS SUCH AN
IMPORTANT TOPIC.
AND I HAVE I GUESS TWO
QUESTIONS/COMMENTS RELATED TO
RECENT EXPERIENCES THAT I HAVE
HAD.
SO, ONE OF THE THINGS IS THAT IN
THE HEALING COMMUNITY STUDY,
WHICH IS A LARGE STUDY WITH
COMPLEX ADMINISTRATIVE DATA
MEASURES, WE'RE WORKING TOWARDS
PUTTING THESE INTO A REPOSITORY
BUT ONE OF THE THINGS THAT'S
BECOME CLEAR WORKING ON THE
PROJECT IS THAT EVEN PEOPLE THAT
ARE CLOSE TO THE PROJECT
SOMETIMES DON'T UNDERSTAND THE
LIMITS OR VAGARIES OF SPECIFIC
DATA SOURCES.
AND SO WE CONTINUE TO TALK
INTERNALLY ABOUT THE RISK OF --
THERE'S NOT A RISK NECESSARILY
OF SHARING THE DATA BUT THE RISK
OF ONCE THE DATA ARE SHARED THEM
BEING MISINTERPRETED AND SCIENCE
BEING PUBLISHED THAT ISN'T
EXACTLY ACCURATE BECAUSE OF THE
COMPLEXITY OF DATA SOURCES.
THAT'S ONE THING.
AND THEN THE OTHER IS THAT I
RECENTLY WAS A SUBJECT IN A
STUDY WHICH I DON'T KNOW WHETHER
OTHERS ON COUNCIL RECEIVED THIS,
BUT I RECEIVED A QUERY FROM
SOMEONE WHO IS CONDUCTING A
STUDY AND I THINK THE PURPOSE OF
THE STUDY WAS ABOUT WILLINGNESS
TO SHARE DATA.
AND THOSE RESULTS ARE GOING TO
GET FED BACK TO NIDA, BUT IT WAS
A COLD CALL FROM E-MAIL ABOUT A
SPECIFIC STUDY, LOOKED LIKE A
FORM, CAME TO SHE ASKING IF I
WOULD SHARE DATA, GIVE IT TO
THEM.
THERE WERE PEOPLE I DIDN'T KNOW.
SCIENCE OF WILLINGNESS TO SHARE,
QUALITY, ALL THOSE THINGS WILL
BE IMPORTANT.
IN THAT CASE, I WROTE BACK AND I
MEAN I'M ALWAYS WILLING TO SHARE
BUT I WROTE BACK AND SET, YOU
KNOW, WHAT'S THE NATURE OF THE
PROJECT AND CAN YOU TELL ME
MORE?
I NEVER HEARD BACK.
WITH THE RATE AT WHICH WE
RECEIVE STAND-BY E-MAIL FROM
PEOPLE WHOSE NAMES WE DON'T
RECOGNIZE IT MADE ME WORRY THAT
WE'RE TRYING TO COLLECT
INFORMATIVE DATA FROM PEOPLE WHO
HAVE DATA TO SHARE.
AND THAT ALSO COULD BE
MISINTERPRETED.
>> YEAH, THESE ARE BOTH
EXCELLENT POINTS.
I'M IMPRESSED YOU ACTUALLY READ
THAT E-MAIL.
USUALLY I'LL GET TO THE THIRD OR
FOURTH WORD AND HIT THE DELETE
BUTTON.
THE QUESTION ABOUT ONE OF THE --
THINK ABOUT DATA SHARING AS A
TWO-EDGED SWORD, PART OF THE
CONCERN IS DATA MAY GET MISUSED,
MISUNDERSTOOD, GROSSLY
MISUNDERSTOOD, AND THERE'S NO
MAGIC ANSWER TO THAT.
THERE CERTAINLY HAVE BEEN
EXPERIENCES, I THINK DBGaP HAD
AN EXPERIENCE WITH GENOMIC DATA.
NHLBI PUBLISHED A PAPER IN THE
NEW ENGLAND JOURNAL OF MEDICINE
A FEW YEARS AGO ABOUT THEIR DATA
SHARING EXPERIENCE.
THIS IS PRIMARILY DATA ON
CLINICAL TRIALS.
AND EVERYONE WAS QUITE POSITIVE.
AND A NUMBER OF THE PAPERS WORK
THAT WAS DONE BY INVESTIGATORS,
NOT PART OF THE ORIGINAL STUDY,
THEY DID SOME INTERESTING
THINGS.
THEY PUBLISHED INTERESTING
PAPERS THAT LED TO SOME INSIGHT.
YOU ARE RIGHT.
THERE IS A RISK THAT THEY COULD
BE EITHER DEPARTMENT --
DELIBERATELY MISUSED OR PERHAPS
MORE LIKELY MISUSED BECAUSE OF
LACK OF UNDERSTANDING.
THAT'S-- I DON'T HAVE ANY MAGIC
ANSWER.
I THINK THAT'S ALL THE MORE
REASON WHY IT'S IMPORTANT THAT
DATA BE VERY WELL ANNOTATED.
WHEN I WAS A JUNIOR
INVESTIGATOR, BEFORE I CAME TO
NIH, I DID GET DATA FROM NIH.
SHARED DATA THAT WAS OUT THERE.
I REMEMBER HOW IMPRESSED I WAS
HOW INCREDIBLY WELL ANNOTATED IT
WAS.
THIS WAS -- LATER ON I FOUND
OUT, IT WAS A PROFESSIONAL JOB,
THEY HAD CONTRACTED SOMEONE
PROFESSIONAL DOING THIS AND SO
FORTH.
ONE THING WE DID WHICH I DON'T
KNOW WHETHER THIS IS A PRACTICE
THAT SHOULD BE ENCOURAGE BUD WE
WANTED TO MAKE SURE WE WOULD
REPRODUCE THE SAME PAPER, GET
THE SAME NUMBERS, THAT WAS OUR
CHECK TO MAKE SURE WE ACTUALLY
UNDERSTOOD WHAT WE WERE LOOKING
AT AND THE FIELDS MATCHED UP
WITH WHAT WE THOUGHT THEY WERE
BEFORE THEY WENT ON TO DO
SOMETHING ELSE.
THIS IS AN IMPORTANT POINT.
AN IMPORTANT PART OF OUR
MESSAGING.
>> AMIT, YOU HAVE YOUR HAND
RAISED.
>> YES, SO THIS IS A BIT MORE OF
A COMMENT OR SUGGESTION THAT BE
A QUESTION.
TWO PERSPECTIVES, SO THERE'S
MANY INVESTIGATORS WHO FEEL LIKE
SOMEBODY'S GOING TO SCOOP THEM
ON THEIR OWN WORK SO THEY EITHER
SHARE VERY LATE OR SHARE
SOMETHING THAT IS PARTIALLY
PROCESSED WHERE YOU CAN'T
ACTUALLY MAKE ANY SENSE OF IT
AND COULDN'T EVER PUBLISH A
PAPER FROM IT BECAUSE YOU DON'T
REALLY KNOW HOW IT CAME TO BE,
NOT MUCH DOCUMENTATION.
IN A WORLD NOW ESPECIALLY WITH
NEUROIMAGING WHICH IS MORE AND
MORE ATTENTIVE TO THE ISSUE OF
SAMPLES, AND I THINK IN CERTAIN
INSTITUTES YOU SEE A MUCH MORE
DELIBERATE ATTEMPT TO FUND
SECONDARY ANALYSES, YOU KNOW,
HIGHLIGHTING NIDA HAVING HAD A
CALL, YOU KNOW, DEDICATED FOR
THIS WHICH A LOT OF INSTITUTES
HAVE NOT HAVE, IT'S REALLY AN
OPPORTUNITY TO HIGHLIGHT GOOD
BEHAVIOR AND GOOD COMMUNITY
SUPPORT.
AND TIE THE WILLINGNESS TO SHARE
TO THE ABILITY TO GET NEW
FUNDING ON PUBLIC DATA.
WHICH IS OFTEN NOT PART OF THAT
DISCUSSION, I THINK NIDA HAS
DONE A FANTASTIC JOB ON THAT
FRONT.
>> THANK YOU.
>> ANY MORE QUESTIONS?
I DON'T SEE ANYONE RAISING THEIR
HAND.
AS YOU SEE, MIKE DID EXTREMELY
WELL.
THANKS FOR TAKING THE TIME TO
SPEAK WITH US AND FOR YOUR
LEADERSHIP AS DATA BECOMES MORE
WIDELY AVAILABLE AND QUALITY
DATA BECOMES WIDELY AVAILABLE.
>> THANK YOU VERY MUCH.
ENJOY THE REST OF YOUR MEETING.
>> THANKS.
BYE-BYE.
>> BYE-BYE.
>> SO BACK TO YOU, SUSAN.
>> YES, WE ACTUALLY HAVE A
10-MINUTE BREAK SCHEDULED FOR
NOW.
AND WHEN WE COME BACK WE'RE
GOING TO HEAR CONCEPT CLEARANCES
FROM A NUMBER OF OUR STAFF.
SO 3:27, IF YOU COULD BE BACK AT
3:40, WE'LL GIVE YOU 14 MINUTES
AND START DOING CONCEPTS THEN.
NORA HAS A CONFLICT, WE'LL HAVE
TO LEAVE US FOR -- AND WILL HAVE
TO LEAVE US FOR A WHILE AT 3:42.
>> AND I'LL BE BACK AS SOON AS
THAT MEETING ENDS.
>> RIGHT.
>> THANKS, SUSAN.
WE'RE ADJOURNED UNTIL --
>> UNTIL 3:40.
WE HAVE A LOT OF CONCEPTS TO
GO THROUGH, ONE PERSON FROM EACH
DIVISION DO THE CONCEPTS
QUICKLY.
IF YOU HAVE QUESTIONS STOP US
ALONG THE WAY AND IF WE DON'T
GET THROUGH THEM ALL BEFORE WE
HEAR FROM JOSH DENNY FROM "ALL
OF US" WE CAN FINISH AFTERWARDS.
WE'LL SEE HOW IT GOES.
IVAN, YOUR DIVISION?
>> SURE.
I HAVE THREE CONCEPTS TO
PRESENT, FIRST ONE IS A REISSUE
OF THE BEHAVIORAL AND
INTEGRATIVE TREATMENT
DEVELOPMENT PROGRAM, A PROGRAM
THAT WILL AKLIN HAS BEEN
LEADING, WILL IS DIRECTOR OF THE
BEHAVIORAL PROGRAM.
THE PURPOSE OF THE CONCEPT IS TO
DEVELOP -- REISSUE THE FUNDING
OPPORTUNITY ANNOUNCEMENT TO
SUPPORT RESEARCH FOR DEVELOPMENT
OF BEHAVIORAL AND INTEGRATIVE
THERAPIES, TO ADVANCE BEHAVIORAL
THERAPIES IN THE NIDA DEFINED
STAGES AND GET NEW THERAPIES
ADOPTED AND IMPLEMENTED IN THE
REAL WORLD SETTINGS TO MAKE AN
IMPACT IN THE COMMUNITY.
THE SECOND CONCEPT WAS APPROVED
BY THE HEAL INITIATIVE, HEAL
THERAPEUTICS DEVELOPMENT FOR
OPIOID USE DISORDER IN PATIENTS
WITH COMORBID COMMONLY OCCURRING
MENTAL DISORDERS BY TANYA RAMEY
AND MATT SEGER, THE PURPOSE IS
TO DEVELOP A FUNDING OPPORTUNITY
ANNOUNCEMENT TO SUPPORT RESEARCH
ON THERAPEUTIC INCLUDING
PHARMACOLOGICAL INTERVENTIONS,
THERAPEUTIC DEVICES, DIGITAL
THERAPEUTICS FOR COMORBID OPIOID
USE DISORDERS AND WHAT NIMH
DEFINES AS COMMONLY OCCURRING
MENTAL DISORDERS.
THAT INCLUDES THE BIPOLAR,
DEPRESSION, PTSD, ET CETERA.
SO AS YOU KNOW, THERE IS A BIG
GAP IN THE RESEARCH, MOST OF THE
TIME, THOSE OF YOU WHO RUN
SUBSTANCE ABUSE CLINICAL TRIALS,
IT'S PATIENTS WITH MENTAL
DISORDERS, VICE VERSA.
CLINICAL TRIALS FOR MENTAL
DISORDERS, TO DEVELOP TREATMENT
OF MENTAL DISORDERS TO PEOPLE
WITH SUBSTANCE USE DISORDERS SO
THE GOAL OF THE FUNDING
OPPORTUNITY ANNOUNCEMENT IS TO
CLOSE THAT GAP AND SUPPORT
RESEARCH ON BOTH CO-MORBIDITIES
AND AS I SAID THIS HAS BEEN
SUPPORTED BY THE HEAL
INITIATIVE.
THIRD IS IN TUNE WITH WHAT NORA
MENTIONED DURING HER
PRESENTATION ABOUT THE NEED TO
HAVE TIMELY AND RAPID RESPONSE
TO EMERGING PUBLIC HEALTH
THREATS OF OPIOID DRUG USE,
SUPPORTED BY "HEAL," RAPIDLY
ASSESSING THE PUBLIC HEALTH
IMPACT OF EMERGING OPIOID
THREATS IS THE TITLE.
LEAD IS AIDAN HAMPSON ALSO FROM
MY DIVISION, AND THE PURPOSE OF
THE CONCEPT IS TO DEVELOP
FUNDING OPPORTUNITY ANNOUNCEMENT
WITH SUPPORT RESEARCH THAT CAN
RAPIDLY ASSESS THE HEALTH IMPACT
OF NEW ILLICIT OPIOIDS AND GOAL
TO RAPIDLY DEVELOP ANALYTICAL
TOOLS TO CHARACTERIZE NEW DRUG
THREATS TO HELP POLICYMAKERS
DEVELOP ADEQUATE PREVENTION AND
TREATMENT STRATEGIES AND ALSO
FOR CLINICIANS TO BE ABLE TO
DIAGNOSE AND TREAT PATIENTS
QUICKLY BEFORE USE OF NEW
OPIOIDS ARE SPREAD IN THE
COMMUNITY.
THOSE ARE THE THREE CONCEPTS FOR
MY DIVISION.
ANY QUESTIONS OR ANY COMMENTS?
>> QUICK QUESTION.
THE LIST OF COMMONLY OCCURRING
DISORDERS IS WHAT NIDA HAS?
IS THERE A LIST, CAN YOU TELL US
WHERE THOSE?
>> BY NIMH, BIPOLE AL,
POSTTRAUMATIC STRESS, I THINK
ALSO INCLUDES OBSESSIVE
COMPULSIVE DISORDER.
>> OKAY.
THANK YOU.
>> OKAY.
>> ANY OTHER QUESTIONS?
THEN MOVING ALONG WE WILL GO TO
THE DIVISION OF NEUROSCIENCE AND
BEHAVIOR, THREE PRESENTATIONS,
THREE CONCEPTS PRESENTED.
>> HI, EVERYONE.
THE FIRST TWO ARE FROM NIDA'S
HIV RESEARCH PROCESS, HOW THESE
MECHANISMS ARE AFFECTED BY
SUBSTANCE USE, METHODS FOR
SPRICIAL DISTRIBUTION AT HIGH
RESOLUTION IN BRAIN STRUCTURE.
THE GOAL, EX VIVO TOOL SETS AND
TISSUE PROCURING TO ENABLE HIGH
RESOLUTION ENABLE ANALYSIS OF
HIV INFECTION AND NEUROPATHOLOGY
IN CONTEXT OF DIVERSITY.
SECOND IS FROM SAM ANNANTHAN,
CHANGES IN THE FUNCTION OF
PROTEINS IN THE BRAIN THROUGH
CHANGES IN EXPRESSION,
POST-TRANSLATIONAL
MODIFICATIONS, SIGNIFICANT GAPS
IS NARROW KNOWLEDGE REGARDING
MECHANISMS THAT CONTRIBUTE TO
DEVELOPMENT OF NEUROPATHOGENESIS
AND COGNITIVE IMPAIRMENTS.
GOAL TO SUPPORT RESEARCH FOCUS
ON ELUCIDATING MECHANISMS BY
WHICH ADDICTIVE DRUGS AND HIV
INFECTION CONVERGE TO INDUCE
CHANGES IN BRAIN FUNCTION AND
IDENTIFYING TOOLS TO PREVENT OR
MITIGATE.
THIRD IS SUPPORTED BY HEAL
INITIATIVE, LED BY MYSELF, BRAIN
DEVELOPMENT IS SUSCEPTIBLE TO
INFLUENCE.
THIS CONCEPT SEEKS TO ESTABLISH
BIOBEHAVIORAL AND ENVIRONMENTAL
FACTORS, AND TRAJECTORIES OF
SUBSTANCE USE DISORDERS, GOAL TO
ESTABLISH TOOLS, METHODS,
PIPELINES FOR DATA ACQUISITION
AND ANALYSIS OF VIRTUAL AND
ASSESSMENT FOR RAPID DEPLOYMENT.
>> ANY QUESTIONS, COMMENTS?
FEEDBACK?
>> IN YOUR SECOND CONCEPT YOU
MENTIONED ADDICTIVE DRUGS, CAN
YOU EXPAND THE LIST OF DRUGS, IS
IT OPIOIDS AND MORE?
>> I BELIEVE DR. ANNANTHAN IS ON
THE CALL.
>> ANY SUBSTANCE THAT CAUSES
ADDICTIVE BEHAVIORS.
>> OKAY, THANK YOU.
>> THANK YOU VERY MUCH.
AND WE WILL MOVE TO DESPR.
>> I HAVE NINE CONCEPTS, IF WE
COULD GO TO THE NEXT SLIDE.
FIRST IS HIV RESEARCH PROGRAM,
FOCUSED ON HIV PREVENTION AND
TREATMENT IMPLEMENTATION
RESEARCH IN JUSTICE POPULATIONS
WITH SUBSTANCE USE DISORDER,
FOCUS ON NATIONAL RESEARCH
CAPACITY TARGETING GEOGRAPHIC
REGIONS WITH SPIKES IN HIV
INTERSECTING WITH JUSTICE
SYSTEM.
NEXT, THE GOAL IS TO DESIGN AND
TEST INTERVENTIONS THAT ADDRESS
DYNAMICS THAT INFLUENCE
WORKFORCE RECRUITMENT, TRAINING
AND INFECTION TO IMPROVE QUALITY
OF CARE IN PATIENT OUTCOMES,
STUDIES COULD TARGET INDIVIDUAL
ORGANIZATIONAL OR SYSTEM LEVELS.
THE NEXT CONCEPT IS ALSO THROUGH
THE "HEAL" PROGRAM.
GOAL OF THE THIRD IS TO PROVIDE
SUPPORT FOR ARRAY OF APPROACHES,
ADDRESS OPIOID USE, WITH GOAL OF
ACCELERATING TRANSLATION OF
RESEARCH TO PRACTICE IN THESE
DOMAINS.
THIS PROGRAM WILL EMPHASIZE
IMPLEMENTATION SCIENCE, HYBRID
IMPLEMENTATION, EFFECTIVENESS
TRIALS, AND DISSEMINATION
RESEARCH.
FOURTH IS ALSO A HEAL
INITIATIVE, LED BY SHELLY SU,
SUPPORTING RESEARCH TO EVALUATE
MULTI-LEVEL INTERVENTION FOR
PATIENTS USING LONG-TERM OPIOID
THERAPY TO MANAGE CHRONIC PAIN
AND FOR WHOM RISKS OF CONTINUING
MAY OUTWEIGH BENEFITS OF
CONTINUED OPIOID USE.
THIS PROGRAM WILL INCLUDE
INTERVENTION RESEARCH, WORK ON
DEVELOPING SHARED CLINICAL
DEFINITIONS, AND BUILDING AND
VALIDATING SCREENING TOOLS FOR
INDIVIDUALS ON LONG-TERM OPIOID
THERAPIES.
THE NEXT CONCEPT IS ALSO A HEAL
INITIATIVE, THIS ONE IS LED BY
SARAH RECEIVERMAN, COMMUNITY
HEALTH CENTERS AND SEEKS TO
ADDRESS PREVENTION AMONG
PATIENTS SERVED BY THESE
ORGANIZATIONS, THE SCOPE OF
SCIENCE WILL INCLUDE DEVELOPING
AND TESTING NEW OR ADAPTED
PREVENTION INTERVENTION AND
DEVELOPING IMPLEMENTATION
STRATEGIES TO SUPPORT SCREENING
AND REFERRAL TO PREVENTIVE
INTERVENTIONS IN THESE SETTINGS.
>> WHY DON'T YOU STOP HERE IN
CASE THERE ARE ANY QUESTIONS SO
PEOPLE CAN STILL REMEMBER WHAT
THEY SAW.
>> SURE, YEAH.
>> ANY COMMENTS OR QUESTIONS?
I DON'T SEE ANY HANDS RAISED.
OKAY.
THEN I THINK IT'S FINE TO GO ON
TO THE NEXT ONE.
>> OKAY.
NEXT BATCH, FIRST IN THIS BATCH
IS FOCUSED ON CAREER AWARDS,
IMPLEMENTATION SCIENCE, SEEKING
TO ADDRESS ONGOING OVERDOSE
EPIDEMIC BY SUPPORTING
EARLY-STAGE INVESTIGATORS WHO
CAN MOVER EXISTING TREATMENT AND
PREVENTION PRACTICES INTO
ROUTINE USE.
IT WILL PROVIDE EARLY CAREER
INVESTIGATORS WITH RESEARCH
EXPERIENCE AND IMPLEMENTATION
SCIENCE AND SUPPORT RESEARCH
PROJECTS THEY LEAD.
NEXT IS LED BY SARAH DUFFY,
CRITICAL ISSUE OF ENSURING THAT
INDIVIDUALS, FAMILIES AND PAYERS
CAN ACCESS DATA THAT HELPS
SELECT AND UNDERSTAND WHICH
PROVIDERS ARE MOST EFFECTIVE.
THIS PROGRAM IS GOING TO SUPPORT
RIGOROUS RESEARCH THAT BUILDS ON
EXISTING QUALITY MEASUREMENT AND
MANAGEMENT EFFORTS, AND FULFILLS
GAPS REQUIRED FOR DEVELOPMENT OF
FEASIBLE QUALITY MEASUREMENT
SYSTEMS, SO THESE SYSTEMS CAN
HELP PATIENTS, FAMILIES, AND
PEERS IDENTIFY EFFECTIVE
PROVIDERS AND HELP PROVIDERS AND
CLINICIANS IMPROVE PATIENT
OUTCOMES.
NEXT IS LED BY CARRIE MULFORD,
FOCUSING ON EXPOSURES TO
VIOLENCE, TESTING INNOVATIVE
MODELS OF SERVICE DELIVERY TO
IMPROVE SUBSTANCE USE AND MENTAL
HEALTH OUTCOMES FOR INDIVIDUALS
WHO EXPERIENCED EXPOSURE TO
VIOLENCE, SPECIFICALLY TO
SUPPORT INTERVENTIONS TO TEST
CARE PATHWAYS THAT PROVIDE OUD
SCREENING, PREVENTION AND
TREATMENT REFERRAL OR SERVICES
TO VICTIMS OF VIOLENCE IN
VICTIMS SERVICE SETTINGS OR TO
PROVIDE PTSD SCREENING AND
TREATMENT FOR INDIVIDUALS AS
THEY ARE RECEIVING OUD
TREATMENT.
AND THE LAST CONCEPT IS LED BY
BARBARA OUDEKERK FOCUSING ON
LOOKING AT CHILD WELFARE SYSTEM,
IMPLEMENTING PREVENTION SERVICES
AMONG CHILD WELFARE INVOLVED
YOUTH AND FAMILIES HAS POTENTIAL
TO REDUCE IMMEDIATE AND
MULTI-GENERATIONAL RISK FOR
SUBSTANCE USE DISORDERS.
THIS WILL SUPPORT RESEARCH THAT
TESTS EFFECTIVENESS OF
INTERVENTION TO PREVENT AMONG
YOUTH, CAREGIVERS, FAMILIES
INVOLVED IN THE CHILD WELFARE
SYSTEM.
I BELIEVE THAT IS ALL OF THEM.
ANY QUESTIONS?
>> AGAIN, SEEING NONE, THANK YOU
VERY MUCH, TISHA.
AND THE LAST CONCEPT WE'RE GOING
TO HEAR IS FROM OTIPI, WE'RE
GOING TO ASK YOU TO VOTE ON IT
AFTER TAM PRESENTS IT.
>> GOOD AFTERNOON, EVERYONE.
PROUD TO PRESENT THE CONCEPT,
CODE IN DRUG OVERDOSE, RAPID AND
PORTABLE CAUSE OF DEATH
DETECTION TECHNOLOGIES.
NEXT SLIDE PLEASE.
THE PROBLEM IS 20% OF OVERDOES
DEBTS DO NOT INDICATE DRUGS
INVOLVED, HINDERING ACCURATE
MONITORING OF DEATH RATES AND
ALSO CURBS ABILITY TO IDENTIFY
THREATS IN TIMELY MANNER AND
RESPOND EFFECTIVELY.
THERE'S HIGH VARIABILITY IN
UNDERREPORTING BETWEEN COUNTIES
AND STATES, TO TRY TO SHOW
THERE'S HIGHER UNDERREPORTING IN
CORONERS VERSUS MEDICAL EXAMINER
SYSTEMS, HIGHER REPORTS OF RURAL
VERSUS METRO AREAS, HIGHER
UNDERREPORTING IN LOW INCOME
COUNTIES VERSUS HIGH INCOME
COUNTIES.
ONE OF THE SIGNIFICANT HURDLES
IS RESULTS FROM POSTMORTEM
TOXICOLOGY.
SOME KEY FEATURES ARE ACCURACY,
TIME TO RESULTS, PORTABILITY,
AND AFFORDABILITY AND
ACCESSIBILITY, DEVICES SHOULD BE
A PRACTICAL TOOL FOR CORONERS
AND MEDICAL EXAMINERS, PROPOSALS
MAY INCLUDE DEVICE AND PLATFORM
DEVELOPMENT, BENCHMARKING AND
SYSTEMS IMPROVEMENT.
THANK YOU.
>> THANK YOU.
AS I SAID, WE NEED TO GET A VOTE
ON THIS.
WOULD SOMEBODY VOTE TO APPROVE
THIS CONCEPT DO A MOTION TO
APPROVE THIS CONCEPT.
THANK YOU.
SECOND?
ALL IN FAVOR?
OKAY.
ANY AGAINST?
LET'S SEE.
OKAY.
I THINK WE'RE GOOD TO GO.
THANKS VERY MUCH, TAM.
>> YEAH.
>> OKAY.
JILLIAN, IS JOSH HERE YET?
>> YES.
>> I'M SORRY, THERE ARE TWO
HANDS RAISED, ANNA ROSE?
OR WERE YOU VOTING?
>> THAT WAS RESIDUAL VOTING.
I APOLOGIZE.
SORRY.
>> OKAY.
THAT'S FINE.
DAN, SAME THING, WERE YOU JUST
VOTING OR DO YOU WANT TO MAKE A
COMMENT?
OKAY.
AND JOSH DENNY IS HERE.
SO I WILL INTRODUCE HIM.
I THINK NORA IS UNFORTUNATELY
NOT ABLE TO BE HERE, SHE REALLY
WANTED TO BE.
DR. DENNY IS CHIEF EXECUTIVE
OFFICER AT THE NIH "ALL OF US"
RESEARCH PROGRAM, BEEN INVOLVED
IN THE PROGRAM SINCE INCEPTION,
SERVING ON INITIAL ADVISORY
COMMITTEE, LEADING THE
PROTOTYPING PROJECT AND SERVING
AS P.I. OF THE DATA AND RESEARCH
CENTER.
DR. DENNY SPENT HIS CAREER AS A
PHYSICIAN-SCIENTIST IMPROVING
PATIENT CARE THROUGH ADVANCEMENT
OF PRECISION MEDICINE.
TODAY HE WILL BE DISCUSSING WAYS
THE "ALL OF US" RESEARCH PROGRAM
CAN BE USED TO FIND DRUG ABUSE
SOLUTIONS.
WE LOOK FORWARD TO HEARING HOW
WE MAY COLLABORATE.
DR. DENNY?
IT'S A REAL PLEASURE TO TALK TO
ALL OF YOU.
I APPRECIATE THE OPPORTUNITY AND
INVITATION.
NORA CAN'T BE HERE BUT I
CERTAINLY HAVE THANKED HER FOR
THE INVITATION TO SPEAK AND THIS
IS A POINT THAT'S VERY
INTERESTING FOR US AS A PROGRAM,
SOMETHING WE WANT TO SEE MORE
RESEARCH ON, AND ONE OF THE MANY
USE CASES WE BELIEVE THE "ALL OF
US" RESEARCH PROGRAM.
THE PROGRAM WAS ANNOUNCED IN
2015, LAUNCHED NATIONALLY IN
2018 FOR RECRUITMENT.
OUR MISSION IS TO ACCELERATE
HEALTH RESEARCH AND MEDICAL
BREAKTHROUGHS ENABLING
PREVENTION TREATMENT AND CARE.
FIRST IS NURTURING PARTNERSHIPS,
WITH A MILLION PARTICIPANTS,
REFLECTING DIVERSITY OF THE
UNITED STATES.
WE WANT TO DELIVER ONE OF THE
RICHEST DATASETS BROADLY
AVAILABLE AND SECURE.
WE WANT TO CATALYZE AN ECOSYSTEM
OF COMMUNITIES, RESEARCHERS,
FUNDERS, MAKING "ALL OF US" A
PART OF HEALTH RESEARCH, WITH
THE TEAM BUILT AROUND CORE
VALUES, VERY IMPORTANT TO US.
THAT INCLUDES TRUST WITH OUR
PARTICIPANTS, TRANSPARENCY,
MAKING A DATASET BROADLY
AVAILABLE, BEING A CATALYST FOR
CHANGE IN THE RESEARCH
ECOSYSTEM.
I MENTIONED WE STARTED OUR
NATIONAL LAUNCH IN MAY OF 2018.
AND SINCE THEN MORE THAN 490,000
PARTICIPANTS HAVE CONSENTED TO
JOIN THE PROGRAM.
PARTICIPANTS CAN JOIN AND
PARTICIPATE IN DIFFERENT WAYS,
SHARING DIFFERENT INFORMATION.
WE HAVE COLLECTED NEARLY 300,000
ELECTRONIC HEALTH RECORD FROM
OUR PARTICIPANTS, MANY MORE OF
COURSE HAVE GIVEN US PERMISSION
TO GET THEM.
AND WE CONTINUE TO GROW IN THAT
SPACE, AS WE FIND NEW WAYS OF
GETTING THOSE ACROSS PROVIDERS
AND SYSTEMS.
WE'VE COLLECTED 360,000
BIOSAMPLES, DNA AS THE CORE BUT
WE COLLECT OTHERS.
BLOOD, SERUM, PLASMA, URINE,
CELL-FREE RNA AND DNA.
LIKE MANY PROGRAMS WE WERE
DRAMATICALLY AFFECTED BY
COVID-19.
WE MORE THAN 99% OF OUR
BIOSPECIMEN COLLECTIONS WERE IN
PERSON, WHEN COVID STRUCK.
AND SO WE HAD TO CREATE NEW WAYS
OF ADJUSTING TO THAT, SAFE WAYS
TO ENROLL AND WAYS TO REACH
PEOPLE VIRTUALLY.
SO WE DID VIRTUAL ENGAGEMENT HE
WAS, DELIVERED SALIVA PROTOCOLS
TO SENT KITS IN THE MAIL, HAD TO
TEST THOSE WOULD BE SAFE AS WE
LEARNED ABOUT COVID IN THAT
SITUATION AS WELL.
AND HAVE RESTARTED OUR IN-PERSON
EFFORTS IN SAFE WAYS OVER THE
LAST 18 MONTHS OR SO IN SLOW AND
PROGRESSIVE WAYS.
WE'VE RECRUITED FROM 50 STATES
AND U.S. TERRITORIES.
DARKER AREAS HERE REPRESENT
STATES THAT HAVE HIGHER
PARTICIPATION, LARGELY BECAUSE
WE TYPICALLY HAVE HEALTH CARE
PROVIDER ORGANIZATIONS AS PART
OF THAT BUT WE CAN ENROLL FROM
ANYWHERE VIRTUALLY.
LIKE I SAID, CAN SEND A SALIVA
KIT ANYWHERE SO PEOPLE CAN
ENROLL IN MANY PLACES AND
LAUNCHING TO REACH PEOPLE TO
DONATE BLOOD IN OTHER STATES AS
WELL, WHERE WE CONT -- DON'T
HAVE HEALTH CARE PROVIDER
ORGANIZATIONS.
MISSION, TO OVERREPRESENT
UNDERREPRESENTED POPULATIONS,
80% ARE UNDERREPRESENTED BY
RESEARCH INCLUDING RACE AND
ETHNICITY, OVER 50% IDENTIFIES
AS A RACE AND ETHNICITY OTHER
THAN WHITE NON-HISPANIC.
AND BUT IT'S MUCH BROADER, IF
YOU LOOK AT THE OTHER UBR
CATEGORIES.
MOST OF THE PEOPLE WHO IDENTIFY
AS WHITE NON-HISPANIC END UP
BEING UBR IN SOME OTHER
CATEGORY.
WE THINK ABOUT THAT IN AGE, SEX
AT BIRTH, GENDER IDENTITY,
SEXUAL ORIENTATION, EDUCATIONAL
ATTAINMENT, OTHER FACTORS.
WE'VE ADDED DISABILITY.
.1% IS NOT CORRECT AS WE'VE
IMPLEMENTED, WE HAVE A MUCH
HIGHER PERCENTAGE OF INDIVIDUALS
WHO IDENTIFY AS DISABLED.
WE COLLECT FIVE MAJOR DATA
STREAMS FROM PARTICIPANTS,
ELECTRONIC HEALTH RECORD IS A
CORE TO OUR INFORMATION AND
PHENOTYPICALLY LONGITUDINALLY,
WE ALSO IMPLEMENT SURVEYS
FOCUSING ON KINDS OF INFORMATION
THAT WE DON'T GET FROM
ELECTRONIC HEALTH RECORD.
SO WE LEVERAGE TIME TO DO
THINGS, SUCH AS SOCIAL
DETERMINANTS OF HEALTH, THE MOST
RECENT SURVEY WE LAUNCHED.
WE DID ONE ON COVID, THAT WAS
REPEATED SIX TIMES.
WE'VE ASKED OTHER QUESTIONS,
BASIC QUESTIONS AROUND
DEMOGRAPHICS AND INCOME AND
SOCIOECONOMIC STATUS, ACCESS TO
CARE, PAST MEDICAL AND FAMILY
HISTORY, THINGS LIKE THAT AS
WELL.
WE HAVE A BASIC SET OF PHYSICAL
MEASURES.
I MENTIONED BIOSAMPLES WE
COLLECT, AND THEN WE ALSO ALLOW
PEOPLE TO LINK IN, DIGITAL
HEALTH TECHNOLOGIES RIGHT NOW
THROUGH FITBIT, APPLE HEALTH KIT
DATA AND WE'VE STARTED A PILOT,
GIVING OUT A COUPLE THOUSAND
FITBITS AS WELL TO DIFFERENT
PARTICIPANTS.
ONE OF THE OTHER CORE TENETS OF
OUR PROGRAM IS WE SEEK TO GET
INFORMATION BACK TO
PARTICIPANTS.
AS WE DID ENGAGEMENT STUDIOS IN
17 CITIES, BEFORE WE RECRUITED
OUR FIRST PARTICIPANTS, WE FOUND
IT WAS IMPORTANT TO PEOPLE THAT
THEY VALUED ESPECIALLY GENETIC
INFORMATION BACK.
WE PRESENTED WITH A NUMBER OF
SCENARIOS.
MOST PEOPLE JOINED AND THINK
ABOUT AND HAVE AN ALTRUISTIC
DRIVE TO BENEFIT MEDICAL
SCIENCE, BENEFIT COMMUNITIES,
COMMUNITIES LIKE THEIRS, AND
THAT SORT OF THING.
BUT WHEN YOU THINK ABOUT WAYS WE
CAN INTERACT AND ENGAGE PEOPLE,
AND THINK ABOUT DIFFERENT
ELEMENTS WE CAN RETURN, GETTING
HEALTH INFORMATION BACK FROM
GENETICS WAS NUMBER ONE THING
PEOPLE IDENTIFIED.
THEY TALKED ABOUT GENETIC
ANCESTRY, SOMETHING THAT WE
COULD RETURN MORE SIMPLY BECAUSE
IT DOESN'T INVOLVE INTERACTION
WITH THE FDA, YOU DON'T HAVE TO
DO THE SAME DEGREE OF
VERIFICATION.
YOU'RE NOT NECESSARILY LOOKING
AT RARE GENETIC VARIANTS.
WE LAUNCHED THAT IN DECEMBER OF
2021 AND YOU CAN SEE -- SORRY,
DECEMBER OF 2020, WE'VE BEEN
DOING THIS FOR A YEAR AND A HALF
NOW.
THE KINDS OF INFORMATION THAT WE
RETURNED CURRENTLY WITH GENETIC
ANCESTRY AND NON-HEALTH RELATED
TRAITS AND RETURNED THAT TO --
OFFERED TO OVER 100,000 PEOPLE.
WITH HEALTH INFORMATION, TWO
MAJOR CATEGORIES, HEREDITARY
DISEASE RISK, SO-CALLED ACMG 59,
AND INCLUDING HEREDITARY CANCER
SYNDROMES, SOME HEREDITARY
CARDIOMYOPATHY, ALL INTERVENABLE
IF YOU HAVE A GENETIC VARIANT.
WE DO AS WITH STANDARD PRACTICE
DO THE TEST, CONFIRMATORY
TESTING, OFFER THE CLINICAL TEST
AS WELL.
PHARMACO GENETICS IS ANOTHER
KIND OF INFORMATION THAT WE
FOUND VALUABLE TO PARTICIPANTS,
AND SO WE'RE CURRENTLY GOING TO
BE PLANNING TO RELEASE SEVEN
GENES, RELATED TO CLINICAL
PHARMACOLOGIC PHARMACO GENETIC
LEVEL A GENE DRUG INTERACTION
PAIRS, AND THOSE ARE SOMETHING
WE ALSO PLAN TO RELEASE.
BOTH ARE THINGS THAT WE'RE
TARGETING TO RELEASE WITHIN A
YEAR TIME FRAME, HOPEFULLY THE
END OF 2022, EARLY 2023.
THESE ELEMENTS WE EXPECT ABOUT
3% OF PEOPLE, 2 TO 3% WILL HAVE
A POSITIVE ACMG 59 RETURN OF
RESULT, WON'T KNOW BEFORE WE
TELL THEM.
PHARMACOGENETICS, MOST PEOPLE
WILL HAVE A RESULT THAT'S
ACTIONABLE.
WE'VE LOOKED IN OUR DATA AND
EXPECT 96% OF PEOPLE WOULD HAVE
ACTIONABLE DRUG-GENE INTERACTION
IF THEY HAPPEN TO BE EXPOSED TO
THE DRUG OF INTEREST.
WE TALK ABOUT DOING RESEARCH ON
THE DATASET.
THIS IS A SNAPSHOT OF OUR
CURRENTLY RELEASED DATASET SO WE
FIRST RELEASED DATA TO
RESEARCHERS IN OUR CLOUD-BASED
ENVIRONMENT, IN MAY OF 2020.
AND THOSE DATASETS OF COURSE
LAG, WHERE PEOPLE ARE CURRENTLY
ENROLLING.
WE HAVE ABOUT 330,000 PEOPLE IN
CURRENTLY RELEASED DATASETS, YOU
CAN SEE MEASUREMENTS, EHRs ET
CETERA.
11,000 FIT BIT RECORDS, 20,000
SETS OF DATA DONATED SO FAR,
RELEASED 11,000.
DIFFERENT ORDER OF MAGNITUDE BUT
REPRESENTS A UNIQUE DATASET,
THAT AREN'T THAT MANY PUBLICLY
AVAILABLE DATASETS OUT THERE TO
GO ANALYZE AND TO ANALYZE ACROSS
ALL THESE OTHER DATASETS.
THE FIGURE ON THE RIGHT GIVES A
SENSIBLE LONGITUDINALLALITY OF
OUR DATA BECAUSE THEY GO BACK
AND WE WORK TO GET AS ROBUST
DATA FEET AS WE CAN, EVEN THOUGH
THEY STARTED JOINING IN PILOT
FORM IN 2017 SMALL NUMBERS, MORE
ROBUSTLY IN 2018, GOING BACK 40
YEARS ON SOME PARTICIPANTS,
INCLUDING PEDIATRIC DATA ON SOME
PEOPLE EVEN THOUGH WE ONLY
ENROLL ADULTS 18 OR OVER, WE
HAVE 20,000 PEOPLE THAT HAVE
SHARED DATA FROM CHILDHOOD AS
PART OF THEIR EHR.
SOME OF THOSE GO BACK TO BIRTH.
THE CURRENTLY MOST VOLUMINOUS BY
DATA POINT COUNT IS FITBIT DATA,
AND THAT GOES BACK TO 2010.
UNTIL YOU GET TO GENOTYPES, THAT
WAS THE MOST VOLUMINOUS PART OF
DATA WE HAVE.
WE RECENTLY RELEASED 100,000
WHOLE GENOMES, 165,000 ARRAYS.
A FEW MONTHS AGO.
THAT DATASET INAUGURATED OUR
CONTROL TIER, CONTROL TIER DATA
MOVES FROM DATASET THAT HAD
SHIFTED DATES TO REAL DATES AND
TIME, IT'S A DIFFERENT PROCESS,
SLIGHTLY IN TERMS OF APPLICATION
BUT STILL VERY EASY TO GO
THROUGH AND THERE'S SOME
ADDITIONAL TRAINING TO USE THE
DATASET.
I MENTIONED IT'S ABOUT 100,000
GENOME, 165,000 ARRAYS.
APPROXIMATELY 600 MILLION UNIQUE
VARIANTS, 400 MILLION OCCURRED
AT LEAST ONCE IN THE PLATFORM,
NOT IN NOMAD, A CONGREGATION
SITE WITH TENS OF THOUSANDS OF
GENOMES SHARED.
AND THAT IS OFTEN USED TO SEE
WHAT FREQUENCY OF VARIANTS IS IN
DIFFERENT POPULATIONS.
100 MILLION OF THOSE VARIANTS IN
OUR DATASETS OCCUR IN THREE OF
OUR PARTICIPANTS, SO CERTAINLY
NOT AT THIS POINT LIKELY A
GENOTYPING ERROR.
AND ARE NOT IN NOMAD.
IT SPEAKS TO THE DIVERSITY OF
THE DATASET WE HAVE, UNIQUENESS
OF IT.
AND IN FACT IF YOU LOOK IT'S NO
SURPRISE TO MOST OF YOU THAT THE
VAST MAJORITY OF GENETIC TESTING
SO FAR AND GENETIC GENOME WIDE
ASSOCIATION STUDIES HAVE BEEN
DONE IN EUROPEAN POPULATIONS.
CURRENT DATA AS OF FEBRUARY, 96%
OF ALL GENOME WIDE ASSOCIATION
STUDIES WERE DONE IN PEOPLE OF
EUROPEAN ANCESTRY.
YOU CAN LOOK AT LESS THAN 1% OUT
THERE, BLACK AFRICAN, AFRICAN
AMERICAN, LESS THAN 1% LATINO OR
RESPONSIBLE ISSUE, SO THESE ARE
WHOLE GENOME DATA, NOT JUST
GENOTYPING DATA THIS COLLECTS.
SO GETTING THAT DATA OUT THERE
AND MAKING ANALYSIS EASY HAS
BEEN SOMETHING WE'RE WORKING
TOWARDS, I'LL TELL YOU IT'S A
PROCESS, AND WE CONTINUE TO
EVOLVE.
ONE OF THE THINGS WE RELEASEED
FIRST WAS A DATA BROWSER.
THE IDEA WAS TO MAKE A WEBSITE
THAT YOU CAN GO QUERY, QUERY
RIGHT NOW ON YOUR PHONE OR OTHER
FOLLOWING A QR CODE AND LOOK AT
THE CURATED DATA, SURVEY
QUESTIONS, PHYSICAL MEASURES,
ALL THOSE THINGS AND SEE SIMPLE
CROSS-TABS OF DATA.
THIS IS WHAT'S PUBLIC, SO IT'S
BLURRED, AGGREGATED, WE LIMIT
INTERSECTIONS BUT THE IDEA IS TO
SAY IS A HYPOTHESIS TESTABLE?
HERE'S AN EXAMPLE, LOOKING AT
OPIOID.
ONE THING IS WE MAP ACROSS ERH
TERMINOLOGY, BILLING CODES,
SNOMED AND OTHERS, SO YOU CAN
SEE 6800 PEOPLE HAVE A DIAGNOSIS
OF OPIOID DEPENDENCE.
AND YOU CAN SEE THE OTHER
DIFFERENT CONDITIONS LISTED.
YOU CAN SEARCH THROUGH THOSE AND
SEE WHETHER THE MEDICATION
EXPOSURE OF INTEREST IS FREQUENT
ENOUGH, THINGS LIKE THAT.
TO DO AN ANALYSIS WE HAVE THE
RESEARCHER WORKBENCH.
THIS IS HOW YOU GET ACCESS TO
THAT ROW LEVEL INDIVIDUAL
PARTICIPANT DATASET.
ALL OF OUR DATASETS HAVE
OBVIOUSLY IDENTIFIERS REMOVED,
ALL OPERATE AS NON-HUMAN
SUBJECTS RESEARCH.
WE FORMALLY DO TEST
RE-IDENTIFICATION RISK OF THESE
MODELS.
IT'S A CLOUD BASED CENTRAL
RESOURCE.
YOU DO THE TRAINING AND THEN IT
INCLUDES AFFILIATION,
ESSENTIALLY USUALLY WITH MOST
INSTITUTIONS VERY RAPID APPROVAL
BY THAT INSTITUTION IN AN
AUTOMATED WAY TO BE ABLE TO
ACCESS THE RESOURCE.
ONCE IN THAT WE DO THE WORK IN
OUR CLOUD-BASED MODEL, GRANTED
PASSPORT ACCESS SO YOU CAN
CREATE A WORKSPACE FOR EACH
ANALYSIS, DESCRIBE WHAT YOU'RE
GOING TO DO, YOU HAVE ACCESS TO
DO THE ANALYSIS.
YOU DON'T HAVE TO DO A SEPARATE
IRB PROPOSAL OR YOU'RE GRANTED
ACCESS AS A PERSON AND YOU GET
TO DO THE ANALYSIS AND CREATE
NEW ANALYSES, WORK SETS ON THE
FLY, AND THOSE ARE MADE PUBLIC
AND CAN BE REVIEWED BY RESOURCE
ACCESS BOARD BUT WE DON'T
PREVENT YOU FROM STARTING TO
WORK ON IT THROUGH A FORMAL
PROCESS.
RIGHT NOW ACCESS IS LIMITED TO
U.S. NON-PROFITS AND ACADEMIC
AND HEALTH CARE FACILITIES, IF
YOU'RE A HEALTH CARE FACILITY OR
ACADEMIC FACILITY YOU CAN BE
FOR-PROFIT.
WE RECENTLY EXTENDED ACCESS TO
THAT GROUP WITHIN THE U.S.
AND AS WE GO THROUGH IT.
WE WALK THROUGH BRIEFLY WHAT
IT'S LIKE TO DO A GENOME WIDE
ASSOCIATION STUDY, WITH TEST
DATA.
WE COULD DO THE REAL THING WITH
MANY MORE PEOPLE ACTUALLY THAN
THE SMALL SAMPLE TEST DATA.
AS YOU COME INTO THE WORK BENCH,
USER APPROVED, CREATE A
WORKSPACE.
YOU CAN USE WEB BASED TOOLS TO
POINT AND CLICK THROUGH BUILDING
A COHORT AND SELECTING YOUR
DATASET AND WHAT VARIABLE US
WANT IN YOUR DATASET.
AND THEN IMPORTANTLY MULTIPLE
USERS FROM WORK WITHIN A
WORKSPACE, JUST LIKE SHARING
GOOGLE DOC BE ON -- OR
SOMETHING.
YOU CAN EXPORT INTO A JUPYTER
NOTEBOOK BOOK, CODING BECOMES
INVOLVED TO DO THE STATISTICAL
ANALYSIS TO RUN YOUR PLANK,
HAIL, GENOME ANALYSIS TOOL THAT
WOULD BE DONE THROUGH A NOTEBOOK
TYPICALLY, AND THAT WOULD BE
USING R PYTHON.
IN THIS TEST EXAMPLE HERE, WE
HAVE 10 MILLION VARIANTS, 5,000
PEOPLE.
ONE OF THE GREAT THINGS ABOUT
SUCH AN ENVIRONMENT IS ANYONE
CAN GO THROUGH THAT ANALYSIS, IN
THIS CASE THE COMPUTE
ENVIRONMENT UP TO 1,000 CPUs,
RAN FOR 30 MINUTES, COSTS $30 TO
DO THIS GWAS.
IT DOES REPLICATE THE SIGNAL
THAT TYPE 2 DIABETES WITH THE
SMALLER POPULATION SET.
THE REAL POWER COMES NOT JUST
HAVING GENOME SEQUENCES BUT
MULTIPLE TIMES OF PHENOTYPE
DATA, GENOMIC DATA, THIS GIVES A
SENSE OF HOW MANY DIFFERENT
PEOPLE HAVE DIFFERENT TYPES OF
DATA.
LIKE I SAID, PEOPLE HAVE
PARTICIPATED IN DIFFERENT WAYS
AND SHARE DATA, AND WE ACCRUE
ELECTRONIC HEALTH RECORDS, GET
GENETIC DATA GENERATED AT
DIFFERENT RATES, OVER TIME.
AND WE MENTIONED WHEN WE
LAUNCHED WE HAVE 2,000
RESEARCHERS USING IT NOW, 330
INSTITUTIONS.
MOST OF THE STATES IN THE U.S.
ARE REPRESENTED NOW, AND
IMPORTANTLY MOST OF THE
INSTITUTIONS HAVE SIGNED MASTER
AGREEMENTS WHICH MEANS THAT NEW
RESEARCHERS FROM THE
INSTITUTIONS CAN COME ON, GO
THROUGH THE TRAINING,
ESSENTIALLY VALIDATE THEIR
E-MAIL ADDRESS WITH THEIR
INSTITUTION IN THAT LOOP BACK
HOW MOST OF THESE MASTER
AGREEMENTS WORK.
IF YOU'RE IN THAT GROUP, YOU CAN
GO FROM APPLYING TO USING THE
RESOURCE AND DOING YOUR FIRST
SCIENCE IN LESS THAN TWO HOURS
FOR MOST PEOPLE.
ABOUT 23%, 25% OF OUR
INSTITUTIONS REPRESENT MINORITY
SERVING INSTITUTIONS, OTHER
TYPES OF NON-PROFITS SUCH AS
LIKE DO THESE ADVOCACY GROUPS,
OR COMMUNITY GROUPS.
ABOUT 6500 PROJECTS UNDERWAY.
MOST OF THOSE ARE DISEASE
FOCUSED.
WE HAVE LOTS OF SUPPORT, OFFICE
HOURS, TRAINING WORKSHOPS, WE
HAVE AMBASSADORS WITH DIFFERENT
ICs, TO HELP RESEARCHERS,
THERE'S VIDEOS ONLINE, OTHER
ELEMENTS TO HELP WALK THROUGH
AND OF COURSE HELP DESK
FEATURES.
THIS WALKING THROUGH JUST TWO
EXAMPLES OF RESEARCH DONE HERE,
THE FIRST I'LL HIGHLIGHT IS THIS
WAS THE FIRST PAPER PUBLISHED
OFF THE RESOURCE.
AND WHAT THEY DID, A MACHINE
LEARNING APPLICATION WHERE THEY
WANTED TO PREDICT WHO WITH
GLAUCOMA WOULD NEED SURGERY,
DEVELOPED A MODEL, SINGLE SITE
BUT WHEN THEY BROUGHT THE DATA
INTO "ALL OF US," THE ACTUAL
PERFORMANCE ALGORITHM WAS AUC OF
.5.
RANDOM CHANCE, DID NOT WORK
WELL.
AS THEY BUILT MODELS TRAINED ON
MULTI-SITE DATA ACROSS EHRs,
THAT SORT OF THING, MODELS
BECAME MORE ROBUST AND ACHIEVED
FAR BETTER PERFORMANCE.
YOU SEE BEST PERFORMING MODELS.
I LIKE THIS IDEA, MULTI-SITE
DATA, DIVERSE POPULATIONS TO
TRAIN MORE ROBUST MODELS AS WE
THINK ABOUT MACHINE LEARNING AND
ARTIFICIAL INTELLIGENCE BECOMING
A MORE IMPORTANT PART OF HOW WE
DELIVER HEALTH CARE.
THERE'S ANOTHER EXAMPLE OF ONE
PUBLISHED MORE RECENTLY, THAT
LOOKED AT ASSOCIATIONS BETWEEN
OPIOIDS AND MARIJUANA USE AND
OTHER CLINICAL FACTORS ON
RETINAL VEIN INCLUSION, THEY
FOUND ASSOCIATIONS WITH OPIOID
USE, IN MARIJUANA USE IT'S ON
THE OTHER DIRECTION OF THE LINE.
IT DID NOT ASSOCIATE WITH RISK
OF HAVING RETINAL VEIN
INCLUSION.
TYPE 2 DIABETES IS A RISK FACTOR
AS WELL.
THERE'S LOTS OF ANALYSES, LOTS
THAT LOOKED AT HOW OUR AGE
ADJUSTED RATES COMPARE TO
NHANES, BECAUSE WE'RE NOT A
REPRESENTATIVE POPULATION.
AND THOSE ANALYSES HAVE BEEN
LIKE EXPECTED AND OTHER
CAUSATIVE ANALYSIS.
AS WE WRAP UP, WHERE WE'RE
HEADED, THESE REPRESENT OUR
STRATEGIC GOALS FOR THE NEXT
FIVE YEARS.
WHERE WE WANT TO BE AT THE END
OF 2026.
OUR FIRST GOAL IS TO ENROLL A
MILLION DIVERSE PARTICIPANTS.
AND TO LAUNCH A PEDIATRIC
RIGHT NOW I MENTIONED THAT WE
ENROLL ONLY PEOPLE 18 OR OVER.
WE HAVE ALWAYS HAD THE MISSION
TO THINK ABOUT ENROLLING
CHILDREN AND PLAN TO EXTEND OVER
THE NEXT FIVE YEARS.
WE LIKELY WON'T BE DONE
ENROLLING CHILDREN IN FIVE YEARS
BUT WILL HAVE BEEN WELL ON OUR
WAY.
NEXT IS TO GENERATE MORE DATA.
OF COURSE, GENOME SEQUENCES,
WE'RE WELL ON OUR WAY THERE.
AND COLLECTION OF MORE HEALTH
DATA, LINKING IN MORE HEALTH
DATA TO FILL IN MORE GAPS, THAT
WE MIGHT HAVE IN TERMS OF
CURRENT COLLECTION OF ELECTRONIC
HEALTH DATA ESPECIALLY FOR
PEOPLE WHO ENROLL IN A PLACE
WHERE WE DON'T HAVE A HEALTH
CARE PROVIDER ORGANIZATION
THAT'S FUNDED TO PROVIDE DATA.
FIGURING OUT WAYS TO DO THAT.
WE'LL OF COURSE ASK MORE SURVEYS
AND WE'LL START COLLECTING AND
LINKING ENVIRONMENTAL DATA.
WE HAVE OUR FIRST PIECE OF
ENVIRONMENTAL DATA LINK IN
RECENTLY, AND WE INTEND TO GROW
THAT.
WITH ALL THESE SAMPLES WE'RE
GOING TO CREATE WAYS FOR OTHER
PARTNERSHIPS TO EXIST WITH OTHER
INSTITUTES AND CENTERS ACROSS
THE NIH AND ALLOW A PROCESS
WHERE OTHER INVESTIGATORS WOULD
BE ABLE TO GET ACCESS TO
SAMPLES, THAT WILL TAKE SOME
TIME.
THAT WILL PROBABLY NOT BE FOR
FIVE YEARS OR SO I SUSPECT
BECAUSE WE'LL START OTHER PLACES
WITH THAT, DEVELOPING THAT
CAPABILITY TO MAKE US MORE THAN
WE ARE AS A PLATFORM TO OTHER
PEOPLE TO USE US.
WE WANT TO GROW OUR RESEARCHER
POPULATION.
IMPORTANTLY WE'RE GOING TO GROW
IT INCLUDING GLOBAL AND
FOR-PROFIT RESEARCHERS AS WELL
AND WE UNDERSTAND AND RECOGNIZE
THE NUMBER OF USE CASES.
ALREADY PEOPLE ARE USING IT TO
TEACH DATA SCIENCE CLASSES IN
COMMUNITY COLLEGES, FOR
INSTANCE.
THINGS LIKE THAT, NOT MAYBE YOUR
TYPICAL OUTCOMES THAT YOU MIGHT
EXPECT TOWARDS PUBLICATION.
WE THINK THESE ARE IMPORTANT
OUTCOMES AS WE THINK ABOUT
GROWING A GLOBAL COMMUNITY OF
RESEARCHERS, ESPECIALLY HERE IN
THE U.S. AND ACROSS DIVERSE
POPULATIONS OF RESEARCHERS WHICH
IS A REAL FOCUS FOR US.
FINALLY IT'S IMPORTANT TO RETURN
VALUE TO PARTICIPANTS AND WE'RE
STARTING WITH GENOMICS, MOVING
TO ELECTRONIC HEALTH RECORDS,
GENOMICS RETURN WILL BE
SOMETHING WE CONTINUE TO LEARN
MORE ABOUT.
AND WE'LL RETURN MORE ELEMENTS
OF EXPANDED RARE VARIANTS, NEW
SETS OF DATA FROM THERE, AND
OTHER TYPES OF THINGS
POTENTIALLY POLYGENIC RISK
SCORES.
I'LL END AND PUT UP URLs.
"ALL OF US" IS OPEN TO ANYONE,
TO USE, TO JOIN.
I ENCOURAGE ALL OF YOU TO USE
THE RESOURCE BECAUSE WE NEED
MORE RESEARCHERS TO USE IT.
WE'RE CREATING A PLATFORM AND
COUNT ON RESEARCH COMMUNITY TO
COME IN AND DO THE SCIENCE ON
TOP OF IT, AND GENERATE NEW
FINDINGS.
SO THANK YOU VERY MUCH.
I'M HAPPY TO TAKE QUESTIONS AS
WE HAVE TIME.
>> JOSH, THANK YOU VERY MUCH.
A WONDERFUL PRESENTATION.
I SEE THAT WE HAVE AMIT WITH
HIS HAND UP.
>> RIGHT.
SO THANK YOU FOR THE
PRESENTATION, JOSH, IT'S QUITE
AN EFFORT.
TWO PARTLY RELATED QUESTIONS.
ONE, WHAT ARE THE PLANS AREN'T
GETTING BRAIN PHENOTYPIC DATA I
VIA EEG, BRAIN ASSESSMENT,
ANYTHING OF THAT SORT, THE
BRAIN-INTERESTING DISORDER CROWD
WOULD BE MOTIVATED BY ON ONE
HAND.
THE OTHER, WHY DELAY OR WHY KIND
OF PHASE IN LATER FOR-PROFIT
RESEARCHERS?
I SAY THIS REALLY AS SOMEBODY
WHO WOULD LOVE TO USE THE DATA
BUT RECENTLY LEFT MY POSITION AT
STANFORD TO FOUND A BIOTECH, SO
I'M ON THE FOR-PROFIT SIDE, WITH
LOTS OF QUESTIONS, MANY FOLKS
COULD BRING DATA TO ACTIONABLE
INSIGHT FOR PATIENTS SOONER, I'D
LIKE TO DIG INTO BOTH.
>> SURE.
I WILL TAKE THE FIRST, FIRST.
AND THE SECOND, SECOND.
I APPRECIATE THE QUESTION.
IN TERMS OF BRAIN PHENOTYPES,
THE FIRST THING TO SAY, WE
PURPOSELY DESIGNED OUR EHR
CAPTURE TO BE BROAD AND BE ABLE
TO HAVE ACCESS TO MORE THINGS
OVER TIME.
ONE OF THE THINGS THAT WE WANT
TO MOVE TOWARDS, FOR INSTANCE,
WOULD BE EVEN CAPTURES AT A
SIMPLE LEVEL OF EEG NARRATIVE
REPORTS YOU MIGHT GET AND THAT
ARE EXTANT IN MEDICAL RECORDS
AND MAYBE OTHER KINDS OF THINGS.
EVENTUALLY THINKING ABOUT THE
CLINICAL RADIOLOGY TESTING
THAT'S THERE, WE WANT TO BRING
IN.
AND THEN IN TERMS OF BEHAVIORAL
COGNITIVE ASSESSMENTS WE'RE
STARTING A PILOT OF ANCILLARY
STUDY WITH NIMH TOWARDS THE END
OF THIS YEAR, THAT WILL ASSESS
SOME MORE QUANTITATIVE MENTAL
HEALTH BEHAVIORS, AND THAT'S A
SET OF TASKS THAT HAVE BEEN
DEVELOPED AND VALIDATED BY THEM
THAT WE'LL BE PUTTING ON THERE.
BASED ON HOW THAT GOES WILL
SCALE INTO BROADER POPULATIONS.
I'M INTERESTED IN GETTING
PRIMARY IMAGING AND WE'LL HAVE
TO SEE HOW OTHER TYPES EVOLVE,
WHETHER IT BE PERSPECTIVE
IMAGING, EEGs OR WHATEVER
MIGHT COME OUR WAY IN TERMS OF
PROPOSALS AND INTERACTIONS
ACROSS THE NIH OR OTHER
INSTITUTES.
AND IN TERMS OF ACCESS, MY GOAL
IS THAT WITHIN ACTUALLY THIS
YEAR, TO START THOSE EXPANSIONS
TO FOR-PROFIT AND INTERNATIONAL
RESEARCHERS, AND IT COMES WITH A
VERY NOVEL ACCESS MODEL, THE
PASSPORT MODEL, CLOUD
ENVIRONMENT, DIVERSE POPULATION,
IT WAS FOUND TO BE IMPORTANT AS
WE TALKED TO OUR PARTICIPANTS
THAT WE DO THIS SLOW -- I
WOULDN'T SAY SLOW BUT THINK
ABOUT TESTING THE SYSTEM, MAKE
SURE WE'RE ASSESSING POTENTIAL
FOR RISK AS WE EXPAND WITH THOSE
ENTITIES THEY FEEL MAYBE ARE
MORE TRUSTED IN SOME OF THEIR
MINDS AS A CATEGORY OF USER AS
IT EXPANDS.
THINGS HAVE BEEN GOING WELL AND
WE LOOK FORWARD TO WORKING OUT
LEGAL PROCESSES TO EXPAND THE
OTHER AILMENTS.
CLEARLY IT'S EASIER TO DO U.S.
AND INTERNATIONAL PROBABLY AS
EASILY RECOGNIZED, THAT'S ONE OF
THE REASONS U.S. COMES FIRST,
EAGER TO GET FOR PROFIT.
>> I WAS INTRIGUED ABOUT THE
PAPER YOU PRESENTED WITH THE
RETINAL VENOUS OCCLUSION WITH
OPIOIDS.
MY QUESTION PERTAINING TO THAT
WHAT PERCENTAGE OF THE EHR
RECORDS BASICALLY HAVE
INFORMATION ON DRUG EXPOSURES,
AND I PRESUME SOME OF THESE
ASSOCIATIONS WERE DUE TO
EXPOSURE TO PRESCRIPTION
OPIOIDS.
SO WHAT IS -- HOW FREQUENTLY ARE
THESE MEASURES BEING TAKEN?
>> IN TERMS OF -- WE HAVE --
PEOPLE ARE PROVIDING
COMPREHENSIVENESS OF THEIR
RECORD THAT THEY CAN GIVE.
AND MOST -- WE HAVE A SET OF
STANDARDS THAT INCLUDE
MEDICATION DATA.
SO PROVIDING WITH HIGH AFFINITY,
PRETTY GOOD DATA QUALITY.
THAT CONTINUES TO EVOLVE.
WE HAVE I GUESS VERY ROUGHLY
MAYBE 70 -- 60, 70% OF
PARTICIPANTS DONATING
BIOSPECIMENS MAYBE WE'VE
COLLECTED AND CURATED EHR DATA
FOR.
THAT MAY BE A FAIR AMOUNT OFF.
I'M JUST TRYING TO REMEMBER AND
ROUGHLY IN MY HEAD.
WE'RE WORKING ON CAPTURE.
IT'S EASY TO TELL WHO HAS EHR
DATA AND WHO DOESN'T.
YOU USE THE DENOMINATOR FOR YOUR
POPULATION OF WHAT KIND OF
ANALYSIS YOU'RE DOING LIKE FIT
BIT, YOU WOULD USE THAT DATA.
IN THE CURRENT DATASET I KNOW
IT'S OVER 200,000 HAVE EHR DATA.
IF THEY HAVE IT THEY ARE GOING
TO HAVE MEDICATION DATA.
OPIATE INFORMATION, FOR
INSTANCE, WOULD COME FROM BOTH
SURVEY QUESTIONS, WHICH WOULD
GET TOWARDS MORE RECREATIONAL
USE OF OPIOIDS OR OTHER DRUGS,
AND PRESCRIPTION DATA,
MEDICATION DATA THAT'S COMING
FROM THE TABLE, EHR IS GOING TO
BE THE PRESCRIPTION BASED DATA
THAT YOU COULD DATE AND TIME AND
LOOK AT EXPOSURE DOSE AND THAT
KIND OF STUFF.
>> THANKS.
ANY OTHER QUESTIONS?
>> LET ME FOLLOW UP AMIT REAL
QUICK, I WOULD ENCOURAGE YOU TO
WRITE IN AND TO -- GO TO
RESEARCH.ALLOFUS.ORG, THERE'S A
BOX THAT SAYS I WOULD BE
INTERESTED IN USING THIS, WE
NEED PEOPLE TO HELP US WORK
THROUGH LEGAL AGREEMENTS AND
THAT KIND OF STUFF.
WE'RE ACTIVELY WORKING ON THAT.
WE WELCOME YOU TO BE ONE OF THE
PEOPLE THAT COME IN AND HELP US
ENGINEER THAT WITH US.
>> VERY HAPPY TO DO THAT.
FOR CONTRAST, U.K. BIOBANK HAS A
MUCH MORE OPEN SHARING POLICY,
NIH DATA ARCHIVE, A LOT OF
SHARING AND RECEIVING FROM, IT
OPEN.
THERE'S A LOT OF PRECEDENCE.
>> WE PURPOSELY DECIDED WE
WANTED TO GO OUT SOONER AND GET
THINGS OUT THERE FASTER BEFORE
WE WERE READY FOR EVERYTHING.
AND SOME PLACES ARE STILL
GETTING IN PLACE.
>> HAPPY TO HELP.
>> YEAH, GREAT.
I'M ALIGNED WITH YOU THOUGH
PHILOSOPHICALLY.
WE'LL GET THERE.
>> THANKS VERY MUCH FOR TAKING
THE TIME AND GIVING US A
PRESENTATION.
I SEE RAJITA HAS A HAND RAISED.
>> YOU TALKED ABOUT THE GENETICS
PHENOTYPING, COULD YOU SPEAK
MORE TO BEHAVIORAL PHENOTYPING
IN TERMS OF DRUG USE BEHAVIORS,
I KNOW THAT BLOOD SAMPLES HAVE
BEEN CONNECTED, URINE SAMPLES
COLLECTED FOR DRUG TOXICOLOGY
AND SEQUENCING OF THAT, JUST
BECAUSE THERE'S ALWAYS SOME
DISCREPANCY WITH LARGE SCALE
SURVEYS IN TIMES OF SELF-REPORT
VERSUS --
>> SURE, YEAH.
WE HAVE URINE SAMPLES ON THE
VAST MAJORITY OF PEOPLE WHO ARE
PROVIDING BIOSPECIMENS.
WE HAVE SERUM AND PLASMA ON THE
VAST MAJORITY OF PEOPLE
PROVIDING BIO BIOSPECIMENS.
WE UNDERTAKEN LARGE SCALE
SURVEY.
IT'S SOMETHING THAT WOULD BE A
POSSIBILITY, LIKE ANY
ANCILLARY.
>> AND HORMONE SAMPLES?
>> YOU'RE PUSHING MY KNOWLEDGE
OF WHAT WOULD BE -- WHETHER
BIOSAMPLES I DON'T THINK IT'S
THE QUALITY FOR CORD STEM BUT I
IMAGINE SOME HORMONES ARE.
>> COMING BACK TO THE QUESTION,
IF YOU HAVE URINE, YOU DID NOT
GET SPECIFIC CONCERN ABOUT
TESTING FOR DRUGS, I MEAN,
YOU'RE NOT GOING TO BE ABLE TO
DO IT BECAUSE YOU HAVE TO HAVE
THAT.
SO IS THIS SOMETHING THAT YOU'VE
ALL THOUGHT ABOUT?
INTERESTING.
YOU GET INTO A COUPLE AREAS.
FIRST WE HAVE BROAD CONSENT
ABOUT WHAT KIND OF ANALYTES WE
COULD TEST FOR AND IT IS VERY
IMPORTANT IF YOU THINK ABOUT
WHAT YOU RETURN OR NOT.
YOU KNOW, YEAH, THIS IS A DEEP
DIVE I HAVEN'T DONE.
AND WE ALWAYS HAVE THE ABILITY
TO RECONSENT BUT TESTING
COULD -- THERE ARE INTERESTING
LINES BECAUSE TESTING, SOME
COULD BE DONE IN DE-IDENTIFIED
WAYS.
I DON'T KNOW THE ANSWER TO YOUR
QUESTION.
ONE I'D BE HAPPY TO EXPLORE.
>> YEAH, EXPLORE IT AND LET US
KNOW.
IS IT ILLICIT TO TAKE DRUGS THAT
CAN PUT PEOPLE IN A PRECARIOUS
POSITION, SO I THINK IT'S
DEFINITELY WORTH LOOKING INTO
WHAT LEVEL OF ANONYMITY WOULD BE
POSSIBLE THEN TO DO THAT
TESTING.
I ACTUALLY DON'T KNOW.
WE CAN ALSO LOOK AND FIND
INFORMATION.
>> COULD BE INTERESTING POINT OF
DISCUSSION.
>> THANKS VERY MUCH.
WE'LL BE TALKING.
>> THANK YOU.
THANKS, EVERYONE FOR THAT
OPPORTUNITY.
>> BYE-BYE.
IT IS 4:33.
THIS IS A TIME WHERE WE HAVE AN
OPPORTUNITY FOR PUBLIC COMMENTS.
THE PUBLIC COMMENTS HAVE BEEN
SENT TO YOU BEFORE COUNCIL.
DO WE HAVE ANY PUBLIC COMMENTS
THAT YOU CAN READ FOR US?
>> NO, WE DO NOT.
WE ALSO WILL CONTINUE TO ACCEPT
PUBLIC COMMENTS FOR UP TO TEN
DAYS AFTER THIS MEETING, AND
WE'LL CONSIDER THAT WE'LL
RECEIVE -- WILL RECEIVE CAREFUL
CONSIDERATION OF PUBLIC COMMENTS
WE RECEIVE.
>> OKAY.
AND THAT IS EVERYTHING THAT I
HAVE ON THE AGENDA UNLESS IF
THERE'S ANYONE AT THIS TIME FROM
COUNCIL THAT WANTS TO BRING UP
ANYTHING BEFORE WE ADJOURN?
>> I JUST WANT TO REMIND PEOPLE
ABOUT CRAN COUNCIL TOMORROW
WHICH ALSO STARTS AT 11:00.
WE LOOK FORWARD TO SEEING YOU
THERE AS WELL.
>> ARE THERE ANY MISSING
COMMENTS?
I THINK ANNA ROSE IS SAYING
GOOD-BYE.
IF THERE ARE NO MORE QUESTIONS
OR ISSUES, THEN I GUESS, SUSAN,
WE CAN ADJOURN UNTIL TOMORROW.
>> THANKS VERY MUCH.