IT IS MY DISTINCT PLEASURE TO
WELCOME YOU TO TODAY'S MEETING
OF THE "HEAL," HELPING TO END
ADDICTION LONG TERM
MULTI-DISCIPLINARY WORKING GROUP
MEETING.
SO, TODAY IS THE FIRST OF A
TWO-DAY MEETING, THIS FIRST
PORTION OF THE MEETING WILL BE
MADE LIVE THROUGH NIH VIDEOCAST,
SO PLEASE BE AWARE THAT YOUR
COMMENTS WILL BE SEEN BY FOLKS
TUNING IN, THE MEETING WILL ALSO
BE RECORDED.
SO WE HAVE A REALLY WONDERFUL
SET OF PROGRAMS MOVING FORWARD
THROUGH THE INITIATIVE THAT YOU
WILL HEAR ABOUT TODAY.
AND WE WILL START WITH SOME
WORDS OF WELCOME FROM MYSELF AND
THEN INTRODUCTIONS AND ROLL CALL
OF THE M OF MULTI-DISCIPLINARY
WORKING GROUP MEMBERS AND "HEAL"
EXECUTIVE COMMITTEE JOINING
TODAY AND WE'LL HEAR FROM
DOCTORS NORA VOLKOW AND WALTER
KOROSHETZ ABOUT CURRENT TOPICS
IN HEAL INITIATIVE TO SHARE WITH
THE BROADER GROUP.
SO, WITH THOSE WORDS OF WELCOME,
THANK YOU, EVERYONE, FOR MAKING
TIME IN YOUR BUSY AUGUST FOR
JOINING US, AND CONTRIBUTING TO
THIS COLLABORATIVE EFFORT.
I'LL TURN IT OVER TO ERIN
SPANIOL TO GO THROUGH ROLL.
>> RECORDING IN PROGRESS.
>> HELLO, GOOD MORNING,
EVERYONE.
I'M GOING DOWN THE LIST TO START
WITH MDWG MEMBERS I SEE.
SO I DO SEE DR. JONES, CAN YOU
PLEASE TURN ON YOUR CAMERA AND
SAY HI?
>> GOOD MORNING, OR GOOD
AFTERNOON.
>> GOOD MORNING.
OKAY.
DR. NUNES, YOU'RE NEXT.
>> GOOD MORNING.
>> GREAT, WE CAN HEAR YOU, GOOD
MORNING.
DR. GARLAND, GLAD YOU MADE IT
IN.
DO YOU WANT TO TURN ON YOUR
CAMERA?
>> GOOD TO SEE EVERYONE.
HOPEFULLY YOU CAN SEE ME.
>> YES, WE CAN.
WE CAN HEAR YOU GREAT.
DR. JERNIGAN?
>> GOOD MORNING, EVERYBODY.
>> GOOD MORNING.
ALL RIGHT.
I SEE DR. KUNTZ.
>> GOOD MORNING.
>> HELLO, GOOD TO SEE YOU.
DR. PAICE, YOU'RE NEXT.
>> GOOD MORNING.
>> ALL RIGHT.
AND THEN DR. HENRY?
>> YES, GOOD MORNING.
>> WE CAN HEAR AND SEE YOU.
AND I THINK A FEW OTHER PEOPLE
POPPED ON WHILE --
>> THIS IS LYNN DEBAR, THANK YOU
FOR FIXING MY LINK, I'M ON.
>> GOOD, GLAD TO SEE YOU ON.
SORRY TO THOSE WHO HAD SOME
TROUBLE JOINING THIS MORNING BUT
GLAD TO SEE YOU.
ANY OTHER MDWG MEMBERS THAT
POPPED ON THAT I MISSED?
ALL RIGHT.
SOME OTHERS WILL BE JOINING A
LITTLE BIT LATER IN THE MEETING.
IN ADDITION TO THE MDWG MEMBERS
WE HAVE MEMBERS OF OUR EXECUTIVE
COMMITTEE ON.
DR. KOROSHETZ, SAY HELLO.
>> HI, FOLKS.
GOOD TO BE HERE TODAY.
>> THANKS, WALTER.
DR. VOLKOW.
>> GOOD MORNING, WELCOME.
>> GOOD MORNING.
GOING THROUGH THE LIST, THERE
ARE A FEW EXECUTIVE COMMITTEE
MEMBERS THAT WILL BE JOINING
LATER ESPECIALLY WHEN SOME
FUNDING PLANS WILL BE DISCUSSED,
BUT IN ADDITION TO THOSE
ATTENDING LATER THERE ARE SOME
DELEGATES THEY HAVE ASKED TO
JOIN FOR THEM.
SO CHRISTINE COLVIS, DO YOU WANT
TO SAY HELLO?
SHE MIGHT HAVE JUST POPPED OFF.
DR. ATKINSON IS ON.
>> HELLO, EVERYBODY.
THANK YOU FOR ATTENDING.
>> DR. ELJEE JUST JOINED, HE ON
BEHALF OF DR. KOO, THAT'S
EVERYONE I SEE, IF THERE ARE
OTHER DELEGATES THAT BO LIKE --
WOULD LIKE TO SAY HELLO, IF I
MISSED YOU, PLEASE DO SO NOW.
>> ALLAN BASEBAUAM AS JOINED.
>> HI, EVERYONE.
GOOD TO SEE YOU.
>> HI THERE.
>> HEY, ALLAN.
>> ALL RIGHT.
WELL, IN ADDITION TO THE
EXECUTIVE COMMITTEE MEMBERS,
THEIR DELEGATES, THERE'S ALSO
MEMBERS OF OUR CO-CHAIR
COMMITTEE, LEADERS OF THE
SCIENTIFIC TEAMS.
SO IF YOU ALL WANT TO SAY A
QUICK HELLO, AND THEN THAT'S
PRETTY MUCH OUR LIST FOR THIS
MORNING.
>> GOOD MORNING, EVERYONE.
THANKS FOR JOINING TODAY.
>> GOOD MORNING, EVERYBODY.
>> EXCELLENT.
THANK YOU.
I'M VERY EXCITED, AS YOU WILL
SEE OVER THE COURSE OF THE
TWO-DAY MEETING IN FRONT OF US
WE HAVE A LOT OF NEW RESEARCH TO
TELL YOU ABOUT, AND PROPOSALS TO
SHARE, BUT BEFORE WE GET STARTED
I'D LIKE TO SITUATE US IN OUR
MISSION, AND OUR AREA OF
COLLECTIVE ACTION, SCIENTIFIC
SOLUTIONS TO THE NATIONAL CRISIS
OF OPIOID MISUSE AND PAIN WITH
TWO PRESENTATIONS.
FIRST FROM DR. NORA VOLKOW,
DIRECTOR OF THE NATIONAL
INSTITUTE ON -- ACTUALLY, NORA,
GO AHEAD.
EVERYONE KNOWS NORA.
NIDA DIRECTOR, DR. NORA VOLKOW.
>> HELLO.
I THOUGHT YOU WERE GOING TO
CHALLENGE ME, ARE YOU NOT
CHANGING THE NAME OF THE
INSTITUTE?
YES.
>> NO, YOU HAVE, RIGHT?
>> NOT YET.
WE HAVE TO GET APPROVAL
OFFICIALLY.
I'M NOT ALLOWED TO OFFICIALLY
STATE IN THE FUTURE WE MAY
BECOME THE NATIONAL INSTITUTE ON
DRUGS AND ADDICTION, UNTIL THEN
I HAVE TO SAY WE'RE THE NATIONAL
INSTITUTE ON DRUG ABUSE.
WE'RE TRYING TO GET RID OF THAT
"ABUSE" WORD.
>> FEARLESS LEADER, PLEASE TAKE
US AWAY.
>> OKAY, THANKS A LOT FOR
INTRODUCING ALL OF US AND IT'S A
PLEASURE TO BE HERE.
I'M GOING TO BE DOING TODAY,
JUST GIVE YOU IN TEN MINUTES AN
UPDATE OF SOME OF THE ISSUES
THAT PERTAIN TO THE OPIOID
CRISIS AND WHICH WE NOW REFER TO
AS THE OVERDOSE CRISIS, BECAUSE
OBVIOUSLY THEY ARE DRIVING SOME
OF WHAT WE NEED TO TARGET OUR
RESEARCH.
IF IT'S OKAY, REBECCA, CAN I
SHARE MY SCREENS OR DO YOU WANT
TO DO IT OVER THERE?
>> I THINK WE HAVE YOUR SLIDES
BUT IF YOU WOULD LIKE TO SHARE
AND ARE PREPARED TO DO SO,
PLEASE GO AHEAD.
>> I'D LOVE TO SHARE, SO WHY
DON'T I SHARE.
LET ME SEE.
OKAY.
I'M GOING TO NEED TO JUST --
JUST TELL ME, DO YOU SEE IT?
>> YES.
>> OKAY, GOOD.
SO, FIRST I WANT TO GO OVER
WHERE WE ARE IN TERMS OF THE
NUMBERS.
AS YOU KNOW, THE COVID PANDEMIC
HAS ACTUALLY SIGNIFICANTLY
INCREASED THE NUMBER OF PEOPLE
THAT HAVE DIED FROM OVERDOSES
ACROSS THE UNITED STATES.
THE LARGEST INCREASES WERE
OBSERVED ON 2020 BUT THEY HAVE
CONTINUED AND ARE BASICALLY
INCREASING OVER BASELINE VERY,
VERY HIGH RATES.
SO, THIS IS THE LATEST DATA FROM
CDC, AS OF FEBRUARY 2022, FOR
THE 12 MONTHS THAT PRECEDED THAT
PERIOD IN WHICH THERE WERE
RECORDED 108,642 OVERDOSE
DEATHS.
AND THAT CLOSE TO 12% INCREASE
FROM THE VERY, VERY HIGH NUMBERS
WE ALREADY HAD FROM 2021.
AS I'VE DONE IN THE PAST, I WANT
YOU TO PAY ATTENTION TO DATA IN
FRONT OF YOU BECAUSE, AGAIN, IT
GIVES US PERSPECTIVE ABOUT HOW
RAPIDLY THIS OVERDOSE CRISIS IS
CHANGING, WHICH WE ACTUALLY NEED
TO TARGET.
FIRST OF ALL, WE'RE SEEING A
CONTINUOUS DECREASE IN THE
OVERDOSE DEATHS FROM HEROIN.
WE'RE ALSO SEEING DECREASES IN
OVERDOSE DEATHS ASSOCIATED WITH
PRESCRIPTION OPIOIDS.
IMPORTANTLY, I WANT YOU TO PAY
ATTENTION, WE'RE SEEING
DECREASES IN OVERDOSE DEATHS
ASSOCIATED WITH METHADONE.
I'LL COME BACK TO WHY THIS IS
RELEVANT.
ON THE OTHER HAND, WE'RE SEEING
SIGNIFICANT INCREASES IN
OVERDOSE MORTALITY, BOTH FROM
SYNTHETIC OPIOIDS AS WELL AS
STIMULANT DRUGS, THOSE ARE THE
ONES DRIVING THE VERY HIGH RATES
OF MORTALITY DURING THE COVID
PANDEMIC, PREDOMINANTLY
FENTANYL.
YOU MAY SAY NUMBERS ARE HIGHER
FOR COCAINE AND AMPHETAMINE
OVERALL, WE HAVE TO CONSIDER IN
ABSOLUTE TERMS THE NUMBERS ARE
MUCH HIGHER FOR FENTANYL AND
OVERDOSE DEATHS, 60 TO 75% OF
THEM, ARE ASSOCIATED WITH
COMBINATION WITH FENTANYL.
HOW BAD IS THE EFFECT OF THE
COVID PANDEMIC?
I THINK IT IS IMPORTANT BECAUSE
IT'S GUIDING US TOWARD SOME
ISSUES AND CHALLENGES THAT WE'RE
FACING.
THIS IS DATA THAT IDENTIFIES IN
DIFFERENT COLORS THE NUMBER OF
OVERDOES DEATHS BEFORE THE
PANDEMIC IN BLUES, DURING THE
PANDEMIC IN PURPLES AND REDS.
FOR DIFFERENT RATES AND
ETHNICITY GROUPS, DIVIDED BY MEN
IN THE LEFT, AND WOMEN ON THE
RIGHT, DIVIDED BY GROUPS.
AND THIS IS THE GROUP, 19 TO 64
YEARS OF AGE, HIGHEST RATES OF
MORTALITY.
IN FACT THE OVERDOSE MORTALITY
ACCOUNTS FOR GREATER NUMBER OF
DEATHS FROM COVID.
IF YOU LOOK AT IT, IT'S CLEAR
THAT MALES OVERALL HAVE HIGHER
RATES THAN FEMALES.
WE ALSO SEE HIGHER RATES OF
DEATH AMONG 35 TO 64 THAN 15 TO
34 BUT THERE ARE NOTABLE CHANGES
HAPPENING VERY, VERY RAPIDLY
DURING THE COVID PANDEMIC, AND
THAT IS THE VERY HIGH RATE OF
OVERDOSES THAT WE'RE OBSERVING
IN GROUPS OF VULNERABLE RACE AND
ETHNIC GROUPS, ONE OF THEM IS
BLACK AMERICA, AND YOU CAN SEE
THAT SIGNIFICANT RISE IN BLACK
AMERICANS, AND SIGNIFICANT RISE
IN AMERICAN AND ALASKA NATIVES,
THE TWO GROUPS, IN RATE OF
OVERDOSE DEATHS HAVE THE HIGHEST
MORTALITY OVERALL BY FAR.
IF YOU LOOK AT WOMEN, I THINK IT
IS IMPORTANT THAT WE LOOK AT THE
GROUPS, BECAUSE OTHERWISE THEY
GET LOST, THE WHOLE AVERAGING,
LOOK AT WOMEN THAT ARE AMERICAN
INDIAN AND ALASKA NATIVES, HAVE
BY FAR THE HIGHEST RATES OF ANY
OTHER GROUP.
SO THIS DATA IS TELLING US AMONG
THE MOST VULNERABLE FOR OVERDOSE
ARE BLACK AND AMERICAN INDIAN
GROUPS, PARTICULARLY MEN, AND
FOR WOMEN, AMERICAN INDIAN AND
ALASKA NATIVES.
AND THIS WAS NOT THE CASE,
SEARCH NOT FOR BLACK AMERICANS,
AT THE BEGINNING OF THE OVERDOSE
CRISIS.
IT'S ALSO IMPORTANT LOOKING AT
THIS NEW DATA THAT WE UNDERSTAND
AND ASK THE QUESTION WHAT IS
DRIVING THESE OVERDOSES IN THESE
UNDERREPRESENTED GROUPS?
THIS DATA FROM THE CDC INDICATES
THAT ONE OF THE FACTORS THAT IS
ACCOUNTING FOR INCREASING
MORTALITY, THAT WE OBSERVED
DURING THE COVID, IS VERY MUCH
DRIVEN IN PART BY INCOME
INEQUALITY, AND THIS IS EVIDENT
IN BLACK, HIGH INCOME
INEQUALITY, MUCH HIGHER RATES
AMONG COMMUNITIES WITH LOW
INCOME, LOW INCOME THAN THOSE
WITH HIGHER INCOMES, IN BLACK,
WHITE, HISPANIC.
IT IS NOTABLE THIS IS NOT
OBSERVED IN AMERICAN INDIAN AND
ALASKA NATIVES, BEGS THE
QUESTION WHAT IS GOING ON THAT
ACTUALLY WHAT OTHER FACTORS ARE
DRIVING THESE VERY HIGH RATES OF
OVERDOES DEATH IT'S IN THESE
GROUPS.
NUMBERS ARE QUITE CHILLING.
OVERDOSE DEATHS INCREASED BY 44%
IN ONE YEAR AMONG BLACKS, 39%
AMONG AMERICAN INDIANS AND
ALASKA NATIVES, DATA IN 2020.
DATA GOES INTO ACTUALLY
IMPORTANT INFORMATION RELEVANT
FOR SOME OF THE DISCUSSIONS THAT
WE'RE GOING TO HAVE TODAY.
WE KNOW THAT THE MAIN STRATEGIES
THAT WE HAVE FOR ADDRESSING THE
OVERDOSE CRISIS ARE EXPANDING
ACCESS TO TREATMENT, MEDICATIONS
FOR OPIOID USE DISORDER,
EXPANDING ACCESS TO NALOXONE.
THESE INVESTIGATORS LOOKED AT
PERCENTAGE OF THOSE PEOPLE THAT
HAVE AN OVERDOSE FATALITY THAT
HAD DIED AND LOOKED AT THE
PERCENTAGE THAT HAD EVIDENCE OF
TREATMENT FOR SUBSTANCE USE
DISORDER OF ANY TYPE, AND
WHETHER THEY HAD BEEN
ADMINISTERED NALOXONE.
WHAT YOU CAN SEE IS THAT LESS
THAN 16 OVERALL OF THESE
INDIVIDUALS HAD RECEIVED
TREATMENT.
EVEN THOUGH WE KNOW AND WE
RECOGNIZE THAT THIS IS CRUCIAL,
PROBABLY THE MOST POWERFUL TOOL
WE HAVE, TO OVERCOME THE
OVERDOSE CRISIS, ONLY A SMALL
PERCENTAGE IS GETTING IT.
SIMILARLY, I WAS SURPRISED TO
SEE SO LOW NUMBERS OF NALOXONE
ADMINISTRATION BECAUSE WE HAVE
BASICALLY IDENTIFIED THESE AS
ONE OF THE MOST IMPORTANT
INTERVENTIONS, EXPANDING ACCESS
TO NALOXONE, ONLY 20% OR LESS OF
INDIVIDUALS HAD ACCESS TO
NALOXONE.
AND I ALSO PUT THESE DATA HERE
BECAUSE I THINK THEY ARE
RELEVANT FOR OUR DISCUSSIONS,
AND THIS WAS RELATED TO THE
NUMBER OF INDIVIDUALS THAT
RECEIVED PAIN TREATMENT.
OVERALL, IT'S LESS THAN 10%,
WHICH INDICATES THAT THE
MAJORITY OF THESE INDIVIDUALS
THAT ARE DYING FROM OVERDOSES
ARE NOT BEING DRIVEN, PROBABLY
ACTUALLY IMPORTANTLY, BY
PRESCRIPTION OPIOID MEDICATIONS
BY THEIR PROVIDERS.
BUT THOSE IDENTIFIED ACTUALLY
10% IS NOT A NEGLIGIBLE AMOUNT
IN TERMS OF INDIVIDUALS THAT ARE
SUFFERING FROM PAIN CONDITIONS
THAT REQUIRE TREATMENT.
AN IMPORTANT QUESTION THAT
ACTUALLY AS ONE IS ADDRESSING
THE ISSUE OF IF WE ARE NOT
PROVIDING MEDICATIONS FOR OPIOID
USE DISORDER, HOW BIG OF A GAP
DO WE HAVE, HOW MANY PEOPLE ARE
NOT RECEIVING TREATMENT.
IN ORDER TO GET THAT NUMBER AT
THAT NUMBER WE HAVE BASICALLY
MANY OF US BEEN STRUGGLING TO
TRY TO IDENTIFY THE VERY
IMPORTANT INDICATOR, HOW MANY
AMERICANS SUFFERING FROM AN
OPIOID USE DISORDER, BECAUSE THE
DATA JUST DOES NOT MAKE SENSE.
OVERALL, FOR EXAMPLE, THE DATA
FROM SAMHSA, ONE OF THE MAIN
SURVEYS, HAS BEEN INDICATED THAT
APPROXIMATELY 2.2 MILLION
INDIVIDUALS SUFFER FROM AN
OPIOID USE DISORDER.
IF YOU FOLLOW THAT, AND WE KNOW
MORE THAN A MILLION INDIVIDUALS
ARE BEING GIVEN MEDICATIONS FOR
OPIOID USE DISORDER, THIS WILL
IMPLY CLOSE TO 50% OF PEOPLE ARE
RECEIVING TREATMENT.
BUT THAT'S NOT WHAT WE ARE
OBSERVING.
SO RESEARCHERS HAVE NOW
BASICALLY DONE ANALYSIS TO TRY
TO GET A BETTER ESTIMATE OF WHAT
IS THE REAL NUMBER OF
INDIVIDUALS WITH OPIOID USE
DISORDER.
AND THE ESTIMATES ARE GOING
BETWEEN 7.6 MILLION TO 10
MILLION INDIVIDUALS WITH OPIOID
USE DISORDER DISPENDING ON
METHODOLOGY YOU USE, WHICH
BASICALLY BRINGS DOWN THE NUMBER
OF PEOPLE THAT WOULD BENEFIT
FROM A MEDICATION OF OPIOID USE
DISORDER THAT ARE RECEIVING IT
TO 13.4% BASEDDED ON THIS
ESTIMATE HIGHLIGHTING ONE OF THE
MAIN CHALLENGES WE HAVE IS TO
EXPAND ACCESS TO MEDICATION FOR
OPIOID USE DISORDER FOR THOSE
WHO NEED IT.
AND THIS IS WHERE I COME BACK
WITH THE SLIDE I SAID I WAS
GOING TO BE TOUCHING BEFORE.
WE HAVE SEEN A REDUCTION IN
METHADONE OVERDOSE DEATHS, AND
THIS HAPPENED AT THE TIME
METHADONE RESTRICTION WENT DOWN,
SO OPIOID TREATMENT PROGRAMS
WERE ABLE TO PROVIDE WITH
TAKEHOME METHADONE FOR
INDIVIDUALS THAT IN THE PAST
WOULD HAVE NOT DONE SO.
THEY CAN BRING UP TO FOUR WEEKS
OF MEDICATION, THIS LED TO A LOT
OF CONCERN THAT WOULD RESULT IN
AN INCREASE IN METHADONE
OVERDOSE DEATHS.
THIS DID NOT HAPPEN.
AND THIS IS DATA FROM JANUARY 20
SHOWING PERCENTAGE OF OVERDOSES
FROM METHADONE AND THIS IS AT
THE TIME THAT WE HAVE THE COVID
PANDEMIC RESTRICTIONS, YOU SEE
INCREASE OVERALL, BUT YOU CAN
SEE OVERALL THE NUMBER OF
METHADONE OVERDOSE DEATHS HAS
DECREASED.
WHAT ARE THE IMPLICATIONS?
IMPLICATIONS ARE THAT RELAXATION
OF THESE POLICIES TO BRING HOME
METHADONE MADE IT FEASIBLE FOR
MANY PATIENTS TO ACCESS THE
TREATMENT AND MUCH EASIER TO
STAY IN TREATMENT AND WAS NOT
ASSOCIATED WITH OVERDOSE DEATHS.
THIS HAS LED TO A LOT OF
DISCUSSION AS IT RELATES TO
CONCEPT SHOULD THESE CHANGES BE
MADE PERMANENT?
SIMILAR FINDINGS ARE REPORTING
NO EVIDENCE OF INCREASES IN
BUPRENORPHINE OVERDOSE DEATHS,
DESPITE RELAXATION OF SUCH
MEASURES.
IN FACT FOR METHADONE THE NUMBER
OF OVERDOES DEATHS FROM
BUPRENORPHINE IS GOING DOWN.
SO WHAT'S GOING ON?
WHAT IS DRIVING MANY OF THESE
INCREASES DESPITE ACTUALLY
NUMBER ONE WE'RE NOT PROVIDING
SUFFICIENT MEDICATION TREATMENT
FOR THOSE THAT NEED IT.
NUMBER TWO, WE'RE NOT PROVIDING
SUFFICIENT NALOXONE DOSES
NECESSARY.
AND WE'RE FIGHTING AN ILLICIT
MARKET MAKING IT MORE
CHALLENGING.
I HIGHLIGHT THE SLIDE THAT SHOWS
ELICITLY MANUFACTURED PILLS THAT
CONTAIN FENTANYL WILL YOU ARE
DISGUISED AS OTHER PRESCRIPTION
DRUGS.
SUCH AS ADDERALL, BENZENE
PRODUCTS SUCH AS ATIVAN,
INCREASED INCREASED, AT PRICES
MUCH LOWER THAN THOSE OF
BASICALLY PRESCRIPTION DRUGS
THAT MAKE IT INTO THE ILLICIT
MARKET.
THIS HAS PUT PEOPLE AT RISK OF
BUYING THEM SUCH AS TEENAGERS,
FOR EXAMPLE, WE'RE OBSERVING
SIGNIFICANT INCREASES FOR THE
FIRST TIME IN OVERDOSES FROM
FENNEL AMONG ADOLESCENTS, THE
RISING OVERDOSE DEATHS FROM
FENTANYL, LIKELY TO BE DRIVEN BY
INCREASES IN ILLICIT MARKET OF
PRESCRIPTION DRUGS THAT CONTAIN
FENTANYL.
SO THEY ARE GETTING OVERDOSE
WITHOUT REALIZING THEY ARE
CONSUMING FENTANYL.
SO WHEN WE TAKE THIS
INFORMATION, AND WE PUT IT IN
FRONT OF US IN TERMS OF
CHALLENGES AND OPPORTUNITIES WE
HAVE FROM RESEARCH, WHAT ARE
SOME OF THE ISSUES?
CLEARLY WE CANNOT STOP IN ANY
WAY TO ACTUALLY ADVANCING
RESEARCH ON BETTER TREATMENT FOR
PEOPLE THAT SUFFER FROM PAIN.
IT'S CRUCIAL.
IF NOT, THEY WILL GO INTO THE
ILLICIT DRUG MARKETS AND BECOME
AGAIN A MAJOR TARGET FOR
OVERDOSE DEATHS.
WE NEED TO CONTINUE TO PROVIDE
TREATMENT FOR OPIOID USE
DISORDER.
IT IS CRUCIAL.
WE NEED TO DEVELOP MODELS THAT
WILL ENABLE US TO DO THAT IN A
SUSTAINABLE FASHION.
BUT WE ALSO NEED TO BASICALLY
RECOGNIZE THAT WE'RE GOING TO
NEED TO TAILOR THOSE
INTERVENTIONS FOR GROUPS THAT
OTHERWISE ARE NOT GOING TO BE
SEEKING THEM SUCH AS WE'VE SEEN
FOR AMERICAN INDIANS AND ALASKA
NATIVES.
OR FOR BLACK AMERICANS.
WE ALSO NEED TO EMPHASIZE THE
IMPORTANCE OF TREATING OTHER
SUBSTANCE USE DISORDERS APART
FROM OPIOIDS BECAUSE THESE ARE
CURRENTLY STIMULANT DRUGS ARE
BASICALLY VERY FREQUENTLY
CONTAMINATED WITH FENTANYL,
PUTTING THESE INDIVIDUALS AT
RISK FOR OVERDOSES.
AND WE NOW DO NEED TO CONSIDER
THAT INDIVIDUALS THAT MAY BE
OCCASIONAL DRUG USERS, THE
TEENAGER, THE OLDER PERSON
SEEKING DRUGS, MEDICATIONS WHEN
THEY ARE PHYSICIANS ARE NOT
PRESCRIBING THEM IN THE ILLICIT
MARKET IS NOW A TARGET SO WE
NEED TO VAMP OUT PREVENTION
EFFORTS FOR TARGETING
INDIVIDUALS THAT MAY BE MISUSING
DRUGS.
AND WE ALSO NEED TO ACTUALLY
KEEP ON FIGURING OUT BETTER WAYS
TO OBTAIN MORE TIMELY DATA
RELATED TO OVERDOSES, ALL OF THE
DATA THAT I SHOWED YOU ARE AT
LEAST SIX MONTHS OLD, AND THINGS
ARE HAPPENING RIGHT NOW.
THINGS ARE ACTUALLY CHANGING
QUITE ABRUPTLY, INCLUDING THE
EMERGENCE OF NEW DRUGS AND
RECOGNITION THAT MORE AND MORE
PEOPLE WITH OVERDOSES HAVE
MULTIPLE DRUGS.
WHAT ARE SOME OF THE DRUGS THAT
HAVE CAUGHT THE ATTENTION OF THE
MEDIA?
GABAPENTIN HAS REALLY NOT BEEN
IN OUR RADAR, AND USED FOR
TREATMENT OF PAIN.
SO WE'RE SEEING 10% IN OVERDOSE
DEATHS WITH OPIOIDS CONTAIN
GABAPENTIN.
THE QUESTION IS IS THIS
ILLICITLY PROCURED OR PART OF
MEDICATIONS THAT HAVE BEEN
PRESCRIBED TO INDIVIDUALS?
WE NEED TO DEVELOP ANTIDOTES
THAT ADDRESS THE CHALLENGES OF
OVERDOSES THAT ARE ASSOCIATED
THAT MIGHT NOT BE AS RESPONSIVE
TO NALOXONE.
AND WITH THAT I WANT TO THANK
YOU FOR YOUR ATTENTION, AND I
THINK AS WE TURN BACK THE SCREEN
TO REBECCA SO THAT SHE CAN HELP
US INTRODUCE DR. WALTER
KOROSHETZ.
>> WE HAVE A TIME DEDICATED FOR
DISCUSSION AFTER THIS NEXT TALK,
SO I'LL TURN IT DIRECTLY OVER TO
DR. WALTER KOROSHETZ, DIRECTOR
OF THE NATIONAL INSTITUTE ON
NEUROLOGICAL DISORDERS AND
STROKE.
WELCOME, WALTER.
THANK YOU.
>> THANK YOU VERY MUCH.
AND YES, WE WANTED TO TALK TODAY
ABOUT A PROJECT REBECCA AND I
HAVE BEEN ENGAGED IN.
REVISITING THE PUBLIC/PRIVATE
PARTNERSHIP WITH BIG PHARMA.
DR. COLLINS' IDEA WAS A
COLLABORATIVE BETWEEN BIG PHARMA
AND NIH DEVELOPING NON-ADDICTIVE
PAIN MEDICATIONS, AND FOR
VARIOUS REASONS BIG PHARMA HAS
NOT BEEN HEAVILY INVOLVED, MOST
OF OUR GRANTEES ARE IN THE
BIOTECH SPACE, MOST OF BIG
PHARMA HAS ACTUALLY LEFT THE
PAIN RESEARCH SPACE, PAIN
DEVELOPMENT SPACE, ELY LILLY
BEING ONE OF THE EXCEPTIONS.
AND SO BUT FOR US WE HAVE
NUMEROUS PROGRAMS WHICH WE'LL
TALK ABOUT THAT ARE ALL AIMED AT
DE-RISKING THE DEVELOPMENT OF
NON-ADDICTIVE PAIN THERAPIES AND
AT SOME POINT FOR THIS TO BE
SUCCESSFUL WE THINK THAT BIG
PHARMA HAS TO BE ABLE TO SEE THE
ADVANTAGES OF TAKING SOMETHING
ON AND MOVING IT TO PATIENTS,
BECAUSE THAT'S REALLY THE ONLY
WAY WITH THESE MEDICINES ARE
REALLY GOING TO GET OUT TO
PEOPLE.
SO THINKING OF THE BIG PICTURE
WE THOUGHT IT WAS WORTH
REVISITING THIS ISSUE, GIVING
WHAT IS GOING TO BE THE ROLE OF
BIG PHARMA, HOW CAN WE IMPROVE
OUR COMMUNICATIONS THERE TO
ENABLE THERAPIES TO EVENTUALLY
MOVE OUT INTO THE COMMERCIAL
SPACE.
NEXT SLIDE.
SO, WHAT WE DID IS TALKED TO ONE
OF THE MULTI-DISCIPLINARY
WORKING GROUP PEOPLE, KEN
VERBER, HE RAN THE PROGRAM FOR
PFIZER LILLY WHICH HAD A LOT
GOING FOR IT IN TERMS OF PAIN,
BUT BECAUSE OF SAFETY ISSUES IT
WAS NOT APPROVED BY THE FDA, AND
PFIZER AND LILLY HAVE ABANDONED
THAT PROGRAM.
KEN HAD LOTS OF IDEAS, ALL GOOD
IDEAS.
NOT ALL WE CAN DO, BUT ALL GOOD
IDEAS.
AND ONE OF THEM WAS, HE SAID,
WELL, MOST OF THE BIG PHARMA IS
REALLY OUT OF PAIN SO YOU'RE NOT
GOING TO BE ABLE TO FIND PEOPLE
THERE TO TALK SPECIFICALLY, YOU
KNOW, ABOUT PAIN, EXCEPT IF YOU
GO TOWARDS KIND OF THE NEUROLOGY
PROGRAMS WHERE, YOU KNOW, IF
PAIN IS GOING TO COME BACK IT
MIGHT BE THROUGH THE NEUROLOGY
PROGRAM.
SO HAVING A NUMBER OF CONTACTS
OF NEUROLOGISTS AND BIG PHARMA,
WE SET UP A SERIES OF ONE-ON-ONE
CONVERSATIONS, WE'RE GOING TO
TALK TO YOU A LITTLE BIT ABOUT
WHAT THEY SAID, NOT GOING TO
REALLY -- TRY HARD NOT TO
QUALITY WHAT WE AGREE WITH OR
NOT BUT THIS IS KIND OF A
REPORT-OUT.
WE INCLUDED BILL SCHMIDT, HE
WORKS WITH A LOT OF THE BIOTECH
COMPANIES AND CLIFFORD WOOLF WHO
IS ALSO ON THE "HEAL"
PARTNERSHIP COMMITTEE ACADEMICS.
NEXT SLIDE.
SO, JUST TO REVIEW, I CAN'T GO
INTO ALL THE DETAILS, WE HAVE
REALLY SUBSTANTIAL INNOVATIVE
PROGRAMS TO MOVE, TO IDENTIFY
NEW TARGETS FOR PAIN
THERAPEUTICS AND THEN TO TRY AND
MOVE THESE ALONG, ALONG THE
PATHWAY TO GOING INTO PATIENTS
IN CLINICAL TRIALS.
SO, THIS IS THE NCATS HEAL
PORTFOLIO, AND THEY FOCUS NOT
JUST ON PAIN BUT OPIOID USE AS
WELL.
BUT YOU CAN SEE THEY HAVE A
WHOLE HOST OF DIFFERENT PROGRAMS
AND THEY FOCUS HEAVILY ON THESE
ASSAYS, TISSUE CHIP MODELS,
iPSC-DERIVED NEURONS, AND IN
IDENTIFYING TARGETS AND THEN
PURSUING THEM ALONG THE PATHWAY
TOWARDS PRE-CLINICAL -- TOWARDS
CLINICAL DEVELOPMENT.
NEXT SLIDE.
AND IF YOU PUT THEM ALL TOGETHER
WITH THE OTHER PAIN PROGRAMS,
YOU CAN SEE NCATS DOWN HERE, THE
SCREENING LIBRARY, TISSUE CHIPS,
CELLS, GETTING TO ACADEMICS, TO
VALIDATE THEIR TARGETS, EARLY
STAGE VALIDATION OF THINGS THAT
LOOK PROMISING FROM, YOU KNOW,
THE INSTITUTE-FUNDED SCIENCE,
WHICH OFTEN, YOU KNOW, DOESN'T
WANT TO FUND A LOT OF THE MORE
BORING VALIDATION STUFF, BUT
CRITICALLY IMPORTANT BECAUSE WE
DON'T HAVE A -- WE DON'T HAVE
ANY SHORTAGE OF TARGETS IN PAIN.
THE PRE-CLINICAL PAIN SPACE IS
JUST EXPLODED WITH TARGETS.
THE ISSUE IS WHICH ONES CAN BE
VALIDATED ROBUST ENOUGH TO MOVE
FORWARD.
SO THERE WE HAVE EARLY PLANNING
STUDIES FOR ANALGESIC
DEVELOPMENT.
INITIAL TRANSLATIONAL EFFORT
GRANTS, TO TRY AND GET PEOPLE
INTO A PAIN THERAPEUTIC PROGRAM
THAT WOULD MOVE A LEAD COMPOUND
TO AN IND WITHIN ABOUT FIVE
YEARS, SO THAT'S KIND OF OUR
SIGNATURE PROGRAM WE'RE TRYING
TO GET MOVING INTO.
AND THEN WE ALSO HAVE THINGS TO
AID THE INDUSTRY, PARTICULARLY
PRE-CLINICAL SCREENING PLATFORM
FOR PAIN, WHERE PSYCHOGENICS HAS
A HOST OF PAIN MODELS THAT ARE
SET UP, WELL VALIDATED, AND ANY
ACADEMIC OR SMALL BIOTECH FOLKS
COULD COME IN WITH ASSETS AND
TEST THEM IN THESE MODELS.
AND WE ALSO ARE FUNDING QUITE A
BIT OF SMALL BUSINESS GRANTS IN
THE PAIN SPACE.
I WOULD SAY THAT THE QUALITY OF
THOSE GRANTS HAS REALLY JUMPED
TO ANOTHER LEVEL SINCE HEAL HAS
STARTED, SO WE ARE LOOKING FOR
ACTIVITY IN THAT SPACE, IN TERMS
OF BRINGING THINGS UP THAT MIGHT
BE DE-RISKED ENOUGH TO BE TAKEN
UP BY PHARMA.
WE HAVE THIS NEW PROGRAM TO
REALLY FOCUS ON TISSUE RELATED
TO PAIN THAT'S COMING FROM
HUMANS, DRG, SPINAL CORD, AND
PERIPHERAL NERVE EVEN, TO KIND
OF GET AT ONE OF THE POINTS
YOU'LL HEAR LATER ABOUT MOVING
FOR TOWARDS THE HUMAN
EXPERIMENTAL PARADIGMS.
NEXT SLIDE.
SO, THE BIG QUESTION IS WHAT
WOULD IT TAKE FOR BIG PHARMA TO
ACQUIRE NOVEL PAIN THERAPEUTIC?
I MENTION BIG PHARMA IS PRETTY
MUCH OUT OF BUSINESS, TRUTH OF
THE MATTER IS ALL THE COMPANIES
WE TALK TO DO NOT HAVE ACTIVE
PAIN THERAPEUTIC PROGRAMS RIGHT
NOW.
AT LEAST AT ANY KIND OF MODERATE
STAGE.
SO, THE QUESTION IS WHAT WOULD
IT TAKE FOR THEIR COMPANY TO
COME BACK INTO PAIN, AND
BASICALLY THE TAKEHOME POINT IS
FOR CAN COMPANY TO COME BACK,
THEY NEED PHASE 2 DATA PEOPLE.
SO THERE'S A REAL SHADOW AROUND
PAIN AND DRUG DEVELOPMENT, AND
SO MOST THE COMPANIES SHY AWAY
FROM, YOU KNOW, JUST HEARING
ABOUT SOMETHING THAT'S RELATED
TO PAIN.
SO WHAT IT WOULD TAKE NOW IS
ACTUALLY DATA OF SOME EFFICACY
IN HUMANS WITH A PARTICULAR PAIN
CONDITION IS KIND OF THE
TAKEHOME POINT.
AND OF COURSE WE ARE -- WE DO
HAVE EPPIC NET, SET UP TO
BASICALLY DO JUST THAT, AND
BECAUSE THERE'S SO FEW OTHER
AVENUES TO DO THESE CLINICAL
TRIALS EPPIC NET BECOMES MORE
AND MORE IMPORTANT.
WE WERE TOLD THE ONLY THING THAT
REALLY LOOKS A LITTLE BIT BY
EPPIC-NET IS THE CRO IN BELGIUM,
OTHERWISE WE'RE ALMOST THE ONLY
SHOW IN TOWN IN DOING HIGH
QUALITY PAIN RESEARCH IN PHASE 2
PEOPLE.
THE OTHER THING IS THAT THE
INDUSTRY HAS A VERY NEGATIVE
ASSESSMENT OF HOW ANIMAL MODELS
PREDICT HOW AN ASSET IS GOING TO
BEHAVE IN HUMAN PAIN CONDITIONS,
AND AGAIN I'M NOT GOING TO SAY
THAT THAT'S TRUE OR FALSE, BUT
THAT IS THEIR STATEMENT.
OF COURSE, WHEN ANYTHING FAILS
YOU TRY AND LOOK AND SEE WHAT
THE PROBLEM IS.
I WOULD SAY THAT PROBABLY MORE
THAN ONE THING BUT LET'S GO ON.
SO THE OTHER THING THEY MENTION
THEY WANT TO SEE EVIDENCE OF
TARGET ENGAGEMENT AT AN EARLY
STAGE, SO DON'T WANT TO GO IN
WITH A DRUG AND INTO LIKE A
BLACK BOX SITUATION.
THEY WANT TO KNOW THEIR DRUG IS
HITTING A TARGET IN EARLY STAGE
OF DEVELOPMENT.
TOXICITY IS A REALLY BIG PROBLEM
FOR PAIN MEDICINES, AND THAT'S
PRETTY MUCH WHAT DROPPED NGF
OFF, VIOXX ISSUE, A COUPLE OTHER
THINGS WE HEARD ABOUT, THINGS
THAT MOVED FAR ALONG ONLY TO
FINE LIVER TOXICITY, AUTONOMIC
SIDE EFFECTS, AND RECALL RIGHT
FROM THE BEGINNING DISCUSSIONS
WITH THE FDA, WHEN THERE'S A
DRUG THAT'S FOR PAIN, WHICH IS,
YOU KNOW, EXPERIENCED BY PRETTY
MUCH ANYBODY IN THE COUNTRY,
THEY ARE GOING TO HAVE A HIGH
BAR FOR SAFETY.
OUR PARADIGM HAS BEEN TO MOVE
INTO MORE NICHE AREAS WHERE
THERE'S A DEFINED CONDITION, AND
WE DEVELOP TREATMENTS FOR THE
DEFINED CONDITION WHERE THERE'S
NO CURRENT TREATMENT SO RATIO OF
RISK TO BENEFIT COULD BE
SUBSTANTIALLY DIFFERENT, IN THAT
CASE IN OUR DISCUSSIONS WITH THE
FDA.
AND THEN THE USUAL THING THEY
WANT TO DIFFERENTIATE THEIR
ASSETS FROM TREATMENTS THAT ARE
ALREADY ON THE MARKET, SO THEY
ACTUALLY GET REIMBURSED.
NEXT SLIDE.
SO, MIKE AZARI PRESENTED IN
CLEAR FASHION WHAT HE CALLS
THREE Rs, RIGHT HYPOTHESIS
BASED ON PRE-CLINICAL DATA, WHAT
IS KNOWN ABOUT THE TARGET.
THE RIGHT POPULATION IS A
GROWING DEPENDENCY ON REALLY
WANTING TO GO INTO VERY
WELL-DEFINED PATIENT GROUPS THAT
SHOULD RESPOND TO AN
INTERVENTION THAT ENGAGES THE
BIOLOGICAL TARGET, SO MOVING
INTO KIND OF A NICHE AREA FIRST
IS SOMETHING THAT'S MORE
ATTRACTIVE, IF THAT NICHE AREA
CAN BE WELL DEFINED AS HAVING
PAIN, A PARTICULAR TYPE OF PAIN
THAT WOULD RESPOND TO THE TARGET
YOU'RE TALKING ABOUT.
THE RIGHT DOSE, REALLY
IMPORTANT.
AND THE RIGHT OUTCOME MEASURE.
SO, AGAIN, A LOT OF ANXIETY
ABOUT THE LIKERT SCALE FOR PAIN
THAT WE'RE PRETTY MUCH RELIANT
UPON, AND PEOPLE HAVE BROUGHT UP
POTENTIAL FOR DIGITAL OUTCOMES
THAT COULD BENEFIT PAIN STUDIES,
AT LEAST AT SOME EARLY STAGE,
ALTHOUGH CLEARLY THE PATIENT'S
EXPERIENCE OF PAIN IS WHAT'S
GOING TO DRIVE THINGS IN THE EN.
NEXT SLIDE.
OKAY.
SO, WHAT DO THEY NEED FROM NIH?
WELL, IT GOES BACK TO THE
MODELS.
THEY WANT MODELS THAT CAN BETTER
PREDICT EFFICACY IN HUMANS.
THAT'S WHAT DRUG COMPANIES DO.
THE MORE ROBUST THE MODEL, THE
CLOSER THEY ARE TO HUMAN
CONDITION, THE BETTER.
SO MOVING MORE TOWARDS KIND OF
HUMAN CELLS, THE PRECISION --
HUMAN PRECISION MODELS WE'RE
WORKING ON, THE PSPP MODEL IS
EXTREMELY VALUABLE PARTICULARLY
FOR BIOPHARMA PEOPLE THAT DON'T
HAVE ACCESS TO THOSE MODELS.
BIG PHARMA PEOPLE CAN GET THOSE
MODELS GOING AND THEY USED TO
HAVE THEM IN THEIR COMPANIES.
THEY DID SAY THEY ARE NOT HOT ON
THOSE MODELS, THEY WANT NEW
MODELS, AND THEY REALLY WANT
MODELS, YOU KNOW, THAT WILL
PREDICT A DRUG EFFECT IN THE
HUMAN PAIN CONDITION.
AND SO WORKING ON DEVELOPING
BETTER MODELS THAT MORE REFLECT
THE HUMAN CONDITION MAY BE
SOMETHING THAT "HEAL" SHOULD
MAYBE PUT MORE EFFORT INTO.
BIOMARKERS THAT IDENTIFY
POPULATION LIKELY TO BENEFIT
FROM A DRUG, THAT GOES BACK TO
PICKING THE AREA IN PAIN, THE
PAIN CONDITION THAT YOUR DRUG IS
BEST ABLE TO SHOW BENEFIT IN AND
BE ABLE TO IDENTIFY THAT
POPULATION WITH SOME TYPE OF
BIOMARKER OF INTEREST.
ALSO BIOMARKERS TIED TO EFFICACY
WOULD BE INCREDIBLY IMPORTANT
AND WAYS IN WHICH THE PLACEBO
EFFECT CAN BE BETTER SUBTRACTED
OUT IN PAIN TRIALS TO
DISTINGUISH TARGET ENGAGEMENT
EFFECTS.
SOME PEOPLE TALKED ABOUT
PHENOTYPIC SCREENING FOR NOVEL
TREATMENT, NOT NECESSARILY GOING
AFTER A TARGET BUT GOING AFTER A
PARTICULAR ASSAY AND SCREENING
LARGE NUMBER OF COMPOUNDS TO SEE
IF THE PHENOTYPE YOU WANT, AND I
THINK MOSTLY THINKING OF iPS
CELLS, CAN BE REPLICATED BY ONE
OF THE COMPOUNDS IN A LARGE
SCREEN, ALMOST THINKING OF A
DARPA-LIKE PROGRAM ON A LARGE
SCALE THAT WOULD DO THAT AND
THEN BRING THINGS THROUGH THE
DIFFERENT STAGES IN ONE PIECE AS
POSED TO MULTIPLE GRANTS WE
HAVE.
SOME PEOPLE TALKED ABOUT BASKET
TRIALS, IF A COMPANY HAS AN
AGENT THEY THINK IS GOOD FOR
PAIN THEY MAY NOT WANT TO PUT
ALL THEIR EGGS IN ONE BASKET,
QUOTE/UNQUOTE, BUT HAVE ABILITY
TO TEST ACROSS DIFFERENT PAIN
CONDITIONS, BASKET TRIALS.
WE HAVEN'T REALLY GONE INTO THAT
SPACE.
WE HAVE INSTEAD PLATFORM TRIALS,
WE HAVE DIABETIC NEUROPATHY
PLATFORM THAT WE CAN TEST
MULTIPLE AGENTS ON DIABETIC
NEUROPATHY, THIS WOULD BE THE
KIND OF OPPOSITE OF THAT WHERE
YOU TEST A DRUG IN MULTIPLE PAIN
CONDITIONS, YEAH, MAY NOT BE
SOMETHING WE CAN DO RIGHT AWAY.
WE NEED MORE EXPERIENCE IN
MULTIPLE PAIN CONDITIONS AND
EPPIC NET TO DO THAT.
NEXT SLIDE PLEASE.
IN TERMS OF THEN BIG PHARMA
WORKING WITH NIH-FUNDED CLINICAL
TRIAL CONSORTIA, SO THAT
QUESTION WE ALSO POSED TO THEM,
AND SOME COMPANIES HAVE HAD A
EXPERIENCE PARTICULARLY IN
ALZHEIMER'S, WORKING WITH
ACADEMIC CONSORTIA THROUGH THE
NATIONAL INSTITUTE OF AGING.
AND THE ISSUES AS YOU MIGHT
IMAGINE, YOU KNOW, THE COMPANIES
FEEL THAT THERE MAY BE LESS
CONTROL THAN THEY HAVE WORKING
DIRECTLY WITH A CRO, WORRIED
POTENTIALLY REASONABLY SO THAT
ACADEMIC CONSORTIA MAY NOT MEET
THE SAME CRITICAL TIMELINES A
CRO WOULD, AND IT REQUIRES MORE
HARMONIZATION OF CONTRACTING,
NEED FOR CLEAR DELINEATION OF
ROLES, AND SO BIG PHARMA IS
LOOKING TO SEE WHAT EPPIC NET
DOES.
WE CERTAINLY HAVE SEEN THAT A
LOT OF THESE BARRIERS HAVE
SLOWED DOWN THE ACTUAL MOVEMENT
INTO THE CLINICAL TRIAL, EVEN IN
EPPIC NET.
STILL CONCERN ABOUT REACH
THROUGH, WHERE IN THE GOVERNMENT
MONEY IS INVOLVED IN DEVELOPMENT
THAT SOMEHOW WHICH I CAN'T
IMAGINE HAPPENING BUT THERE IS
CONCERN FROM I GUESS THE LAWYERS
THAT THE NIH COULD POTENTIALLY
TAKE SOME KIND OF ACTION IN
TERMS OF THE DEVELOPMENT.
AND I THINK THAT WAS IT.
NEXT SLIDE.
I THINK WE'RE AT THE END.
YEAH.
NO, NO, NEXT SLIDE IS SOMETHING
TO CONSIDER.
SO I GUESS THE ISSUE IS HOW TO
MOVE FORWARD, SO A COUPLE THINGS
CAME TO MIND.
ONE IS THAT TALKING TO FOLKS,
THE HEAL TRANSLATIONAL PROGRAMS,
ALTHOUGH THEY MAY KNOW SOMETHING
ABOUT THE BIG TOPIC, THEY DON'T
REALLY KNOW THE DETAILS OF WHAT
WE'RE DOING.
AND SO THERE MIGHT BE A NEED TO
SHOWCASE WHAT HEAL IS FUNDING IN
THE SMALL BIOTECH AND ACADEMIA,
SHOW THE INNOVATION THAT'S IN
THE HEAL PROGRAM, VARIOUS
PROGRAMS, GET INPUT FROM BIG
PHARMA ON, YOU KNOW, WHAT THEY
LIKE, WHAT THEY DON'T LIKE,
WHAT'S MISSING.
AND THEY MAY, YOU KNOW, ALTHOUGH
THEY WOULDN'T SPEND A LOT OF
TIME WITH A SINGLE COMPANY WHO
HAS A PAIN ASSET, THEY MIGHT BE
MORE INTERESTED IN COMING TO
SOMETHING NIH PUTS OUT WITH 15
OR 20 BIOTECHS WITH PAIN ASSETS
WE'VE BEEN FUNDING.
I DON'T KNOW WHAT HAPPENED THIS
WEEK EXACTLY, BUT BIOTECH
INVESTMENTS DROPPED OFF A CLIFF,
STARTING ABOUT SIX MONTHS AGO,
AND SO A NUMBER OF THE BIOTECHS
ARE HAVING TROUBLE RIGHT NOW
FINANCIALLY.
THERE ARE POTENTIAL OTHER THINGS
WE COULD DO WITH BIG PHARMA,
EXPLORE JOINT PROGRAMS FOR
TRAINING, WE'RE IN THE CLINICAL
TRIAL NETWORKS, CENTERS, THE
PAIN CENTERS THAT WE FUND HERE
AT "HEAL."
SO THOSE ARE A COUPLE IDEAS THAT
CAME OUT FOR GOING FORWARD FROM
THESE CONVERSATIONS.
I THINK THAT'S THE LAST SLIDE.
LET ME CHECK.
AND SO WITH THAT, YEAH, I WONDER
BEFORE WE GO INTO GENERAL
DISCUSSION, REBECCA, DO YOU WANT
TO SAY ANYTHING IN ADDITION TO
WHAT WAS JUST PRESENTED?
YOU WERE THERE FOR EACH OF THESE
TALKS.
>> OH, YES.
I WOULD ONLY ADD, WALTER, THAT
THIS IS IMPORTANT BECAUSE WE AT
NIH CANNOT COMMERCIALIZE THE
THERAPEUTICS COMING OUT OF OUR
PROGRAM.
SO WE KNOW THAT PEOPLE IN PAIN
NEED ADDITIONAL OPTIONS.
AND WE KNOW NIH RESEARCH ALONE
IS NOT GOING TO BE SUFFICIENT AS
NORA WOULD FRAME IT, TO BRING US
THOSE THERAPEUTIC CANDIDATES.
SO, HOW CAN WE BEST EQUIP OUR
RESEARCHERS TO ESTABLISH THOSE
COLLABORATIONS AND FUNCTIONAL
RELATIONSHIPS WITH THE COMPANIES
SUCH THAT ARE LIKE THE FRUIT OF
OUR COLLECTIVE BROUGHT TO
PATIENTS.
BUT YOU CAPTURED THE DISCUSSION
PERFECTLY.
I WOULDN'T REALLY ADD ANYTHING
ELSE.
I WOULD LOVE TO HEAR THOUGHTS
AND REACTIONS AND FEEDBACK FROM
THESE -- ON THESE TWO VERY BROAD
PRESENTATIONS FROM THE MDWG SO
I'LL OPEN IT UP.
THANK YOU, WALTER.
THANK YOU, NORA.
>> NED HERE.
CAN YOU HEAR ME?
>> YES.
>> GOOD MORNING.
>> YEAH, A COUPLE THOUGHTS.
I NOTICED IN TERMS OF THE BIG
PHARMA HESITATION, ONE OF THE
POINTS IS TIMELINES AND
CONTRACTING.
AND CONTRACTING MULTI-SITE
TRIALS PARTICULARLY BY NIH IS
VERY CUMBERSOME.
I DON'T KNOW HOW TO FIX THAT.
TWO ISSUES.
ONE, CONTRACTING AND
SUBCONTRACTING IS VERY
CUMBERSOME, ALSO IT'S HARD TO
PAY FOR PERFORMANCE WITH, YOU
KNOW, AN NIH STUDY, WHICH IS OF
COURSE EXACTLY HOW PHARMA
STUDIES WORK.
IN OTHER WORDS, A SITE GETS PAID
WHEN IT RECRUITS, AND WHEREAS
WITH NIH YOU HAVE TO GIVE A SITE
MONEY AND HOPE THEY RECRUIT.
WHICH IS NOT AS STRONG AN
INCENTIVE.
I HAVE NO IDEA HOW TO FIX THAT
BUT JUST PUT THAT OUT THERE,
SOMETHING TO TRY TO THINK ABOUT.
AND THEN JUST IN TERMS OF, NORA,
THANK YOU FOR THE GREAT SUMMARY,
WHERE WE ARE.
I JUST WANTED TO EMPHASIZE
THERE'S THE TREATMENT GAP AND
THEN THERE'S THE PROBLEM OF
DROPOUT FROM TREATMENT ONCE
PEOPLE ENGAGE, WHICH IS ALSO A
BIG PROBLEM, PARTICULARLY WITH
BUPRENORPHINE AND NALOXONE.
SO I WOULD JUST ALSO KEEP THAT
UP ON THE RADAR SCREEN, AS WELL
AS WHAT -- WHY DON'T PEOPLE WITH
OPIOID USE DISORDER SEEK
TREATMENT, THAT'S AN IMPORTANT
QUESTION TO ANSWER.
ANYWAY, THANK YOU GUYS.
>> THANK YOU.
I THINK THOSE ARE GREAT POINTS.
WE CAN KEEP MOVING THROUGH THE
LIST.
WALLY SMITH.
>> COULD I JUST SAY ONE THING?
>> GO AHEAD, WALTER.
>> IN TERMS OF CONTRACTING,
YOU'RE ABSOLUTELY RIGHT.
WHAT WE TRY TO DO IS SET THE
NETWORK UP AND HAVE THEM DO ALL
THE CONTRACTS AND HAVE A SYSTEM
SO WHEN THE NEXT -- IT TAKES A
LONG TIME TO GET THE FIRST ONE,
BUT THE HOPE IS SYSTEMS PUT
TOGETHER MASTER AGREEMENT
BETWEEN SITES, THE NEXT ONE IS
MUCH EASIER.
WHAT WE LEARNED IN EPPIC-NET
DEALING WITH SMALL BIOTECHS THEY
SOMETIMES HAVE A DIFFERENT
AGENDA AND MAY DRAG THEIR FEET
FOR REASONS THAT ARE NOT
OBVIOUS, SO BUT ANYWAY, THAT'S
THE POINT WE GO ABOUT.
WE DO GIVE INFRASTRUCTURE, TO
BUILD THE INFRASTRUCTURE WITH
MONEY, BUT SITES GETS PAID FOR
ENROLLEE, SO PAYMENT GOES TO
SITES, THAT DOES DEPEND ON WHAT
THEY ENROLL.
>> THANK YOU, WALTER.
WALLY SMITH, WELCOME.
>> I YIELD TO SHARON WHO HAD HER
HAND UP.
>> I'M SORRY, GO AHEAD, SHARON.
>> THANK YOU, NORA, FOR YOUR
PRESENTATION.
IN THE DATA YOU PRESENTED,
INVESTIGATORS HAD A CHANCE TO
DIG DOWN DEEPER AND FIGURE OUT
SOME OF THE SYSTEMATIC REASONS
WHY THERE ISN'T ACCESS TO CARE,
OTHER THAN ACCESSIBILITY.
THE TREATMENT DRUG.
IF CLINICS AND ADMINISTRATORS
DON'T HAVE ACCESS TO THAT
INFORMATION, THEY CAN'T CHANGE
THE SYSTEM.
>> YEAH, NO, AND I THINK THAT
YOUR QUESTION, IT DIDN'T COME UP
CLEAR, BECAUSE THE SOUND WAS
MUFFLED.
IF I UNDERSTAND IT CORRECTLY,
YOU WERE ASKING ME WHAT ACCOUNTS
FOR THE GAP IN TREATMENT AND
ACCESS TO TREATMENT, IS THAT
CORRECT?
>> THAT IS CORRECT.
HAS ANY OF THOSE INVESTIGATORS
LOOKED AT IT SYSTEMATICALLY SO
THE INFORMATION CAN BE SENT BACK
TO CLINICIANS AND OTHER -- YOU
KNOW, THE PROVIDERS.
>> YEAH, NO, AND THAT SPECIFIC
QUESTION IS CRUCIAL.
IT HAS TO BE OBVIOUSLY FROM THE
DATA I PRESENTED REGIONALLY
SPECIFIC.
AND THAT INFORMATION CURRENTLY
IS NOT AVAILABLE WIDESPREAD
APART FROM IT.
I THINK THAT I DO WANT TO
ABSOLUTELY RECOGNIZE THE POINT
THAT ED WAS MAKING THAT ONE OF
THE BIG CHALLENGES THAT WE HAVE
IS NOT JUST GIVING TREATMENT TO
PEOPLE BUT RETAINING THEM IN
TREATMENT.
SO YOU INITIATE AND THE PERSON
STOPS, THEN THAT BASICALLY PUTS
THEM AGAIN AT VERY HIGH RISK OF
OVERDOSE.
ANOTHER COMPONENT THAT WE NEED
TO WORK ON TO TARGET AND HE
MENTIONED IT, ABSOLUTELY THAT IS
CORRECT, MANY PEOPLE THAT SUFFER
FROM AN OPIOID USE DISORDER DO
NOT REACH OUT TO TREATMENT.
AND THAT ELEMENT WHICH HAS BEEN
SPOKEN ABOUT BUT ALSO IN TERMS
OF WHY IS IT THAT PEOPLE DON'T
REACH OUT TO TREATMENT, ONE OF
THEM IS STIGMA.
A KEY COMPONENT IS STIGMA.
AND THE OTHER ONE THAT IS
RELEVANT IS THE ACCESSIBILITY OF
THAT TREATMENT AND IN THE PAST
WE HAVE BEEN VERY RESTRICTIVE
WITH THE OPIOID TREATMENT
PROGRAMS.
BUPRENORPHINE HAS MADE IT MORE
FLEXIBLE BUT WE'RE ALSO SEEING
THAT ACCESS TO BUPRENORPHINE IS
HINDERED TO CERTAIN GROUPS LIKE
BLACK AMERICANS, AND THIS IS IN
FACT RELATED TO ANOTHER
COMPONENT THAT NEEDS TO BE
ADDRESSED, WHICH IS
REIMBURSEMENT.
SO WE'VE GONE OUT INTO THE
COMMUNITIES TO TRY TO UNDERSTAND
WHY NOT MORE PHYSICIANS THAT ARE
WAITING TO PRESCRIBE
BUPRENORPHINE NOT DOING IT.
THEY SAID BECAUSE REIMBURSEMENT
IS INSUFFICIENT.
SO THERE ARE MULTIPLE FACTORS
THAT ARE CONTRIBUTING TO THAT
GAP THAT ACTUALLY NEED TO BE
ADDRESSED.
AND CRUCIAL IS THAT ISSUE OF
STIGMA BECAUSE IF PEOPLE DO NOT
FEEL THAT THEY ARE GOING TO BE
TREATED PROPERLY, THEY ARE NOT
GOING TO ACCESS TREATMENT.
SO THAT IS A KEY COMPONENT.
>> MAYBE WE CAN THINK ABOUT HOW
TO INCENTIVIZE INVESTIGATORS TO
FIND WAYS TO ADDRESS THOSE
ISSUES, YEAH, YEAH, GOING
FORWARD.
>> AND THAT INCLUDES HOW DO WE
BRING FORWARD INFORMATION TO
ACTUALLY SHIFT THE REIMBURSEMENT
MODEL BECAUSE THAT'S AN ISSUE.
REIMBURSEMENT FOR SUBSTANCE USE
DISORDER IS MUCH LOWER THAN
OTHER MEDICAL CONDITIONS.
>> YES.
THANK YOU.
>> I DID NOT SEE THE LINE, THE
QUEUE.
I'M GOING BACK TO YOU, DR. WALLY
SMITH, AND LET YOU WEIGH IN.
>> GOOD MORNING.
I AGREE WITH EVERYTHING THAT'S
BEEN SAID.
WANTED TO PICK UP ON WALTER AND
ED'S COMMENTS.
TO MY WAY OF THINKING, THE ROLE
THE NIH HAS TO PLAY IS TO FIND
POTENTIALLY COMMERCIALLY VIABLE
COMPOUNDS AND ONLY GET THEM TO A
POINT.
WE DON'T WANT TO BE DOING PHASE
3 TRIALS.
MAYBE NOT EVEN PHASE 2.
I WONDER.
BECAUSE I DON'T THINK WE, NIH,
CAN DO THAT EFFICIENTLY AND I
DON'T THINK WE HAVE A SUFFICIENT
PROFIT MOTIVE.
FROM INDUSTRY'S POINT OF VIEW IF
THEY DON'T SEE PROFIT POTENTIAL
OF A GIVEN COMPOUND, THEY WON'T
DO THE PHASE 2 OR PHASE 3 TRIAL
BECAUSE IT'S NOT IN THEIR
INVESTORS' BEST INTEREST.
SO, THE NEXUS IS TO FIND THE
SWEET SPOT, SOMETHING SALIENT TO
A PATIENT ENOUGH THEY WILL NOT
USE OPIOIDS AND USE THAT PRODUCT
INSTEAD, OR IT WILL RELIEVE
THEIR PAIN SUFFICIENTLY,
SPEAKING ON BOTH SIDES OF THE
TWIN HEAL MISSION, AND IF
THERE'S ENOUGH OF A PROFIT
MOTIVE IN IT FOR IT, FOR
INDUSTRY, I.E. SOMEBODY'S GOING
TO PAY FOR IT, THERE'S A LOT OF
FOLKS, YOU KNOW, ACCESSIBILITY,
ALL OF THOSE THINGS.
I KNOW THAT'S A TALL ORDER BUT
I'M SUGGESTING WE SHOOT WITH A
PRECISION RIFLE AFTER SHOOTING
WITH A SHOTGUN TO IDENTIFY THOSE
POTENTIAL TARGETS.
WE FIND JUST THOSE FEW, AND THEN
WE GO HARD AND FAST TO TRY TO
FIND COMPANIES, AND SAY, HEY,
THERE'S MONEY IN THIS FOR YOU,
LET'S BE HONEST, THERE'S MONEY
IN THIS FOR YOU AND TO PATIENTS,
HEY, THERE'S BENEFIT IN THIS FOR
YOU.
I FEEL THAT IF WE CAN SORT OF
SAY THAT TO OURSELVES AND NOT BE
IN THE BUSINESS OF WASTING
BUCKSHOT OR AIMING AT WRONG
TARGETS WITH PRECISION RIFLES
THAT WOULD BE GOOD.
>> YEAH, PERFECTLY SAID.
>> THANK YOU.
OKAY.
I NOW HAVE THE LIST IN ORDER.
NEXT IS GAIL.
GO AHEAD, GAIL.
>> THANK YOU.
I HAD A COUPLE COMMENTS.
ONE WAS ON THE DIFFERENT
CHALLENGES THAT WE HAVE FOR THE
GAP AND BESIDES ALL THAT WAS
MENTIONED THE STIGMA, LOGISTICS,
WE HAVE TO REMEMBER THAT NUMBER
ONE MANY OF THESE INDIVIDUALS
WE'RE SEEING AT LEAST IN THE
EMERGENCY DEPARTMENT, MORE THAN
50% OF THEM I WOULD SAY MUCH
HIGHER BUT IT'S AT LEAST THAT IN
OUR TRIALS ON HOMELESS, UNSTABLE
HOUSING.
WE'RE EXPECTING TO INITIATE
SOMEONE AND THEN THEY HAVE TO GO
SOMEWHERE ALL THE TIME, THEY
HAVE TO GET THERE.
IT'S NOT WORKING.
SO, WE NEED LONG-ACTING
MEDICATIONS, AND WE HAVE SOME
GREAT PROMISING THINGS THAT WE
COULD PROBABLY DO THOSE IN THE
E.D.
THOUGH I CANNOT FOR LOTS OF
REASONS GIVE A LONG-ACTING BUPE
FORMULATION TRYING TO GET TO MY
COMMITTEES NEXT MONTH TO SOMEHOW
GET IT IN THE HOSPITAL.
I DESPERATELY -- YOU CAN'T
BELIEVE THAT SHENANIGANS I'M
GOING THROUGH WITH A PATIENT, I
TRANSITIONED YESTERDAY, A
NIGHTMARE FOR 24 HOURS, I CAN'T
GET THE LONG ACTING.
I HAVE TO SOMEHOW GET HIM A CAP
AND GET HIM TO A COMMUNITY SITE
AND ORDER THROUGH THE MEDICAID.
IT'S UNBELIEVABLE.
I'M ABOUT TO CARRY HIM MYSELF
OVER THERE.
SO, THOSE ARE THE LOGISTICS BUT
THE LONG-ACTING PREPARATIONS ARE
REALLY EXCITING AS IN THE OTHER
DOSES WHICH I'VE DONE TO SORT
OF -- THE SCIENCE OF THE REALLY
HIGH DOSE OF BUPE BUT
HOMELESSNESS IS IMPORTANT SO
UNLESS WE CAN CAPTURE BETTER
WAYS OF ENGAGING THESE
INDIVIDUALS WE'RE NOT GOING TO
GET ANYWHERE.
THE OTHER THING I JUST WANTED TO
SAY ABOUT THE FUNDING THE SITES
THOUGH I HAVE DONE BOTH.
I HAVE WORKED WITH THYRIN WHO
GIVES A SMALL AMOUNT OF MONEY
AND A TRIAL I'M DOING WITH MANY
E.D.s FUNDED BY THE CTN, AND I
WOULD TELL YOU THAT JUST GIVING
LITTLE BITS AMOUNT OF MONEY YOU
DON'T GET THE RIGHT PEOPLE IN
THIS STUDY.
WE CHERRY-PICK PEOPLE, YOU HAVE
SO ALSO MONEY IT INTO.
SO LITTLE MONEY INTO IT.
I DON'T HAVE MONEY TO KEEP
PEOPLE THERE ALL THE TIME
WHEREAS IF I CAN PROVIDE MORE
RESOURCES, TO A CENTER.
AND THE OTHER HAND I'VE HAD TO
LET SEVERAL CENTERS GO BECAUSE
THEY DIDN'T SAY YOU HAVE TO HAVE
SOME SET IN THE BEGINNING WHAT
YOUR EXPECTATIONS ARE, AND IF
YOU CAN'T MEET THOSE
EXPECTATIONS THEN YOU'RE NOT
GOING TO BE ABLE TO CONTINUE ON.
WE'RE GOING TO HAVE TO PHASE YOU
OUT FAIRLY QUICKLY.
BUT IT'S PROBABLY A COMBINATION
OF THOSE THINGS THAT WORK THE
BEST.
AND THEN IN TERMS OF COMPANIES,
I DON'T KNOW HOW MUCH I CAN SAY
BUT SOME ONE OF YOU PUT ME IN
TOUCH WITH CLAIRE THERAPEUTICS,
I'M WORKING WITH A NEW DRUG
PREPARATION, AND I THINK IT
WOULD WORK VERY WELL TO HAVE THE
COMPANY WITH INVESTIGATORS
BECAUSE WHEN THE BASIC SCIENCE,
AND THEY ARE DOING SOME BASIC
SCIENCE, I GOT THEM IN AT YALE,
WHEN THIS DOES POTENTIALLY GO TO
HUMAN TRIALS I THINK IT WOULD BE
GREAT TO PARTNER WITH THEM
BECAUSE I HAD THE PEOPLE WHO
WOULD DO IT.
AND I'M NOT SURE EVERYONE WANTS
TO DO IT FOR A PHARMACEUTICAL
COMPANY BUT WOULD VERY MUCH LIKE
TO DO IT UNDER A MORE OF AN
ACADEMIC/GOVERNMENT SETTING AS
WELL LIKE NIH TO GET INDIVIDUALS
WHO REALLY ARE COMMITTED TO TAKE
THE TRIAL TO FRUITION.
SO ANYWAY, THAT'S IT.
THANK YOU ALL.
>> GAIL, I THANK YOU FOR
BRINGING UP THE ISSUE HOW
DIFFICULT IT IS TO GET EXTENDED
RELEASE BUPRENORPHINE AND WHY DO
I WANT TO HIGHLIGHT THIS IS THAT
THERE IS EVIDENCE, DEFINITIVELY
FROM DATA COMING FROM THE
JUSTICE SETTING THAT EXTENDED
RELEASE FORMULATION
SIGNIFICANTLY IMPROVES OUTCOMES,
IMMEDIATE RELEASE BUPRENORPHINE,
AND YET THESE TREATMENTS ARE NOT
BEING USED.
SO MY QUESTION FOR ALL OF YOU TO
THINK ABOUT, WHEN WE SPEAK ABOUT
TRANSLATION WE USUALLY THINK
ABOUT WE HAVE A PRE-CLINICAL
FINDINGS, HOW DO WE TRANSLATE
INTO A PRODUCT.
I ALSO THINK IN TERMS OF
TRANSLATION, AS RELATES TO
ULTIMATELY THE DATA THAT WE'RE
GARNERING HOW DO WE TRANSLATE
THAT INFORMATION JUST LIKE JUST
PRESENTED INTO A POLICY THAT WE
WILL PROVIDE SUPPORT FOR
REIMBURSEMENT BECAUSE OTHERWISE
IT'S EXTRAORDINARILY
FRUSTRATING.
WE DEVELOP TREATMENTS MORE
EFFECTIVE AND YET THE COST
BASICALLY PRECLUDES THEIR
IMPLEMENTATION.
THE COSTS ARE SET UP BY POLICIES
THAT ARE DETERMINING HOW MUCH
YOU GET REIMBURSED.
SO I THINK THAT THIS IS
SOMETHING THAT WE WILL PULL OUR
HEADS TOGETHER.
I DON'T KNOW, DR. CARLOS AT
NIDA, HAS BEEN ACTIVE IN THIS
TARGETED TYPE OF RESEARCH
GETTING KNOWLEDGE TO ADVANCE
THAT.
I AGREE WITH YOU, GAIL, AND IT'S
REALLY UNFORTUNATE.
>> THANK YOU, NORA.
I'M GOING TO TURN NOW TO LYNN
DEBAR.
>> I HAD A FEW PIGGYBACK
COMMENTS AND THEN A QUESTION FOR
NORA.
MY COMMENTS WERE GOING BACK TO
WALTER'S PRESENTATION, I WAS
STRUCK BY ONE OF THE COMMENTS
ABOUT THE DISSATISFACTION WITH
LIKERT SCALES AS REALLY OUR
PRIMARY OUTCOME THAT WE'VE BEEN
ABLE TO USE FOR PAIN.
AND JUST -- THIS MAY BE
PROVOCATIVE BUT IN THE CHRONIC
PAIN SPACE THAT REALLY
PRIORITIZING FUNCTIONING MIGHT
BE REALLY IMPORTANT, PHYSICAL,
EMOTIONAL, SOCIAL FUNCTIONING
BECAUSE THOSE ARE THE -- YOU
KNOW, I THINK WHAT'S MOST
IMPORTANT THERE.
AND SOMETIMES I THINK THE ACUTE
PAIN MODEL GETS MIXED IN IN A
WAY THAT'S A LITTLE BIT
UNFORTUNATE.
I WANTED TO COMMENT ON WHAT GAIL
WAS JUST TALKING ABOUT, AND THAT
SHARON BROUGHT UP, ABOUT WHY NOT
MORE MEDICATION FOR OUD, WHERE
ARE SOME GAPS THERE.
AND ALL OF THAT MADE SENSE.
I REALLY AGREE, COULDN'T AGREE
MORE.
I THINK THE OTHER THING WE WOULD
BE WELL SERVED TO REALLY PAY
SOME ATTENTION TO IS TO
RECOGNIZE BECAUSE OF THE STIGMA
AND BECAUSE OF A NUMBER OF OTHER
THINGS THAT PEOPLE ARE OFTEN NOT
AT AN ACTIONABLE POINT IN TIME
SO WHEN PEOPLE ARE APPROACHED
CAN WE BUILD INTO OUR DESIGN
SOMETHING WHERE THAT ENGAGEMENT
PROCESS IS REALLY PART OF WHAT
WE'RE STUDYING?
AND A LOT OF TIMES WITH CLINICAL
TRIALS WE'RE TRYING -- WE HAVE A
NARROW WINDOW GETTING PEOPLE IN.
WE SORT OF LOSE THAT
OPPORTUNITY, BUT THAT AS A
TARGET IN ITSELF, IT WRAPS
AROUND HOW WE CAN GET DATA ABOUT
WHO THOSE FOLKS ARE AND I KNOW
THERE'S LOTS OF INTERESTING AND
REALLY INNOVATIVE WAYS THAT
WE'RE GOING TO TALK ABOUT TODAY
ABOUT USING DATA, BUT HOW CAN WE
IDENTIFY THOSE POPULATIONS, AND
THEN MY COMMENT, MY QUESTION FOR
NORA, THAT I WAS STRUCK BY, IN
YOUR PRESENTATION, THE REALLY
QUICK EVOLUTION IN SOME OF THE
STREET DRUGS, AND ONE OF THE
IMPLICATIONS IN TERMS OF HOW WE
RESPOND AND WHAT VARIOUS ISSUES
ARE, AND I JUST WONDERED IF YOU
COULD COMMENT A LITTLE BIT ON
SOMETHING THAT I CERTAINLY HAVE
BEEN HEARING A LOT ABOUT LATELY
WHICH IS THE SHIFT IN
METHAMPHETAMINE WITH P2P AND
FOLKS SAY THIS IS SHOWING UP
DIFFERENTLY, MORE HARD-TO-MANAGE
BEHAVIOR, PLACES LIKE OREGON HAD
TO CLOSE THEIR -- YOU KNOW,
WHERE THEY WERE TRYING TO HELP
PEOPLE DETOX BECAUSE PEOPLE,
THERE WAS SO MUCH DANGER IN THAT
PROCESS.
IT HASN'T -- YOU KNOW, IT'S
FLOODED MENTAL HEALTH SYSTEMS.
I JUST WOULD BE CURIOUS, IS THAT
URBAN MYTH OR IS THERE REALLY A
DIFFERENCE IN THIS KIND OF RATE
OF ACUTE PSYCHOSIS AND OTHER
THINGS THAT MIGHT MERIT, YOU
KNOW, JUST SOMEWHAT DIFFERENT
KIND OF WAY OF RESPONDING TO IT
OVER TIME OR TRYING TO DEAL WITH
SORT OF ACUTE ISSUES AS WELL AS
WHAT THAT MEANS LONGITUDINALLY.
>> YEAH, NO, LYNN, THANKS FOR
BRINGING THIS ISSUE UP.
I WISH I COULD TELL YOU THERE'S
EVIDENCE IN INDICATES THE
SYNTHESIS PROCESS JUST FOR
METHAMPHETAMINE IS RESPONSIBLE
FOR INCREASED REPORTS OF MORE
PSYCHOSIS, BUT THERE'S NO DATA.
THAT DOESN'T MEAN IT DOESN'T
EXIST.
ARE THERE METABOLITES NOT
PRESENT WHEN METHAMPHETAMINE IS
NOT SYNTHESIZED WITH THE P2P
PROCESS, SOMETHING RESEARCHERS
SHOULD BE LOOKING AT.
YOU'RE PUTTING IT INTO MY RADAR
BECAUSE I DO THINK IT'S
IMPORTANT THAT WE UNDERSTAND THE
CHARACTERISTICS OF THE
METHAMPHETAMINE PROBLEMS.
IT'S LINKED WITH HIGHER TOXICITY
OVERALL, ANOTHER REASON TO TRY
TO UNDERSTAND IT BETTER BECAUSE
THIS CAN BE UTILIZED IN OUR
EDUCATION MATERIALS.
THANKS FOR BRINGING THAT UP.
I WISH I HAD DATA TO TELL YOU
THIS IS THE EVIDENCE.
NO, BUT WE CAN LOOK INTO IT.
>> THANKS.
>> GREAT.
WE'RE GOING TO TALK ABOUT A LOT.
THANK YOU FOR ALLUDING TO SOME
FUTURE TOPICS OF DISCUSSION,
LYNN, BECAUSE WE'RE GOING TO GET
TO A LOT OF THESE LATER IN
TODAY'S MEETING.
TWO MORE COMMENTS IN OPEN
SESSION, HENDREÉ JONES, YOU'RE
NEXT.
>> I JUST WANTED TO HIGHLIGHT
THAT WHEN WE TALK ABOUT STIGMA,
THAT IS OFTEN LIKE THE
STEREOTYPE ATTITUDE, THE BELIEF,
IF WE COULD INCLUED TALKING
ABOUT DISCRIMINATION, ACTIONS
AND BEHAVIORS THAT RESULT FROM
STIGMA, PAIR THOSE TOGETHER,
THAT'S IMPORTANT.
MY QUESTION FOR NORA IS I WAS
STRUCK BY THE AMERICAN INDIAN
AND ALASKA NATIVE DATA YOU
PRESENTED PARTICULARLY FOR
WOMEN.
I WAS WONDERING IF WE KNOW
ANYBODY IS THIS HAPPENING ACROSS
EVERY COMMUNITY OR ARE THERE
COMMUNITIES THAT ARE PROTECTED,
WHERE WE'VE NOT SEEN THE
INCREASES IN OVERDOSES, AND DO
WE KNOW ANYTHING ABOUT THOSE
COMMUNITIES AND CAN WE LEARN
SOMETHING FROM THOSE PROTECTIVE
FACTORS THAT WE COULD APPLY TO
THE OTHER COMMUNITIES?
>> NO, HENDREE, WE NEED TO
ADDRESS DISCRIMINATION TO HELP
US TARGET INTERVENTIONS, AS TO
THE QUESTION OF THE DATA, IS IT
HOMOGENOUS OR HETEROGENEOUS
AMONG AMERICAN INDIAN AND ALASKA
NATIVE POPULATIONS LIKING TO BE
HETEROGENEOUS BUT SPECIFICS
ABOUT WHAT GROUPS MAY BE
RESILIENT WE DO NOT HAVE, AND
I'VE SPOKEN WITH SOME OF THE
TRIBES, FOR EXAMPLE, AND THIS IS
ONE OF THE REASONS.
THEY THEMSELVES DO NOT KNOW
EXACTLY THE MAGNITUDE OF THE
PROBLEM, OTHER THAN THEY
RECOGNIZE THAT IT IS INCREASING
AND THAT IT'S CONSIDERED BY SOME
THE NUMBER ONE CHALLENGE THAT
THEY HAVE, OVERDOSE, AND THIS IS
ACTUALLY GOES OVER SUICIDES
WHICH ARE ALSO HIGHER IN SOME OF
THESE COMMUNITIES.
SO ONE OF THE TARGETED AREAS
THAT WE IDENTIFY IS TO TRY TO
GET SURVEYS INTO AMERICAN
INDIANS AND ALASKA NATIVES
INCLUSIVE OF TRIBES, TO GET A
PERSPECTIVE OF THE MAGNITUDE OF
THE PROBLEM, DEMOGRAPHICS OF
THOSE GROUPS, AND THE CONDITIONS
THEY LEAD ON.
THAT'S WHY I COMMENTED, I WAS
SURPRISED THE CDC DATA DOES NOT
SHOW A DEPRIVATION IN THE
SUCCESS ARE AMERICAN INDIANS AND
ALASKA NATIVES, IT'S HIGH ACROSS
ALL.
ADDRESSING THE QUESTION OF
HETEROGENEITY COULD PROVIDE A
GLIMPSE PERHAPS ON WHAT ARE
FACTORS WE COULD USE TO PROVIDE
RESILIENCE AND WHAT WE NEED TO
TACKLE TO MINIMIZE VERY HIGH
RISK, AND I'M GLAD YOU'RE
BRINGING UP FOR WOMEN BECAUSE
THAT'S ANOTHER AREA WE NEED TO
FOCUS VERY MUCH, WHAT ARE THE
UNIQUE NEEDS TO PROTECT WOMEN
FROM OVERDOSES.
>> YEAH, THANK YOU.
WE DID CONSULT WITH TRIBAL
COMMUNITIES.
WE HAVE A FORMAL PROCESS FOR
DOING THIS, AND "HEAL" LED A
CONSULTATION PROCESS IN THE
SPRING AND RECENTLY RELEASED OUR
REPORT ON WHICH OPPORTUNITIES TO
PURSUE BASED ON THAT.
THERE ARE A LOT OF GAPS IN THE
DATA, A LOT OF AREAS OF NEED.
THERE'S A LOT TO DO THERE.
AND THEN DR. ERIC GARLAND,
YOU'RE LAST IN LINED AMONG THOSE
WITH RAISED HANDS.
GO AHEAD.
>> THANK YOU SO MUCH.
I WANTED TO PICK UP ON THIS
POINT ABOUT TRANSLATION.
TRANSLATION GAP.
ALSO BRING FOCUS TO THE AREA OF
BEHAVIORAL THERAPIES.
SO DISPARITIES NORA IDENTIFIED
IN THE COMPELLING TALK SPEAK TO
LACK OF QUALITY EVIDENCE-BASED
TREATMENT IN UNDERSERVED
COMMUNITIES AND THAT I THINK
REALLY POINTS TO THE SEVERE
TRANSLATION GAP FROM RESEARCH TO
PRACTICE, IN MANY UNDERSERVED
COMMUNITIES TREATMENT AS USUAL
INVOLVES UNTESTED AND SUBOPTIMAL
TYPES OF COUNSELING THAT DON'T
WORK, DON'T ADD MUCH.
BUT WE'VE SPENT A LOT OF MONEY
THROUGH "HEAL" AND NIH TO
DEVELOP EVIDENCE-BASED
PSYCHOSOCIAL INTERVENTIONS LIKE
VARIOUS NOVEL FORMS OF COGNITIVE
BEHAVIORAL THERAPY, MINDFULNESS
BASED INTERVENTION, ET CETERA.
WE NEED TO ATTEMPT MOVING THESE
INTO THE REAL WORLD.
WHAT MECHANISMS EXIST TO HELP
INVESTIGATORS WHO DEVELOPED
NOVEL EVIDENCE-BASED
INTERVENTIONS MOVE THOSE
INTERVENTIONS INTO THESE
COMMUNITIES THAT REALLY NEED
THEM.
HOW DO WE INCREASE THE UPTAKE OF
THESE INTERVENTIONS?
DO WE NEED TO THINK ABOUT
TRAINING GRANTS TO COMMUNITY
AGENCIES TO MOTIVATE THEM TO
BECOME TRAINED AND TO BE ABLE TO
IMPLEMENT THESE PRACTICES WITH
HIGH DEGREE OF FIDELITY?
I DON'T KNOW THE ANSWER HERE BUT
I DO KNOW THAT TO MAKE THIS HEAL
FUNDING IMPACTFUL WE NEED A
MECHANISM THAT CAN HELP
TRANSLATE THESE RESEARCH-PROVEN
TREATMENTS INTO REAL WORLD
CLINICAL PRACTICE.
>> YEAH, NO, I AGREE A ONE
PERCENT, ERIC, AND WOULD ADDED
OTHER NOTION IT'S IMPORTANT WE
ALSO ENSURE THEY ARE SUSTAINABLE
BECAUSE THE ISSUE BEING MANY
TREATMENTS MIGHT BE PROVIDED FOR
A SHORT PERIOD OF TIME, WE
RECOGNIZE TREATMENT, LONG-TERM
TREATMENT IS ASSOCIATED WITH
BEST OUTCOMES.
SO THERE'S THE NEED TO ACTUALLY
TAILOR IT TO THE COMMUNITY,
NUMBER ONE, ABSOLUTELY BECAUSE
OTHERWISE IT MAY NOT BE
ACCEPTABLE.
I THINK THAT THE OTHER ISSUE
THAT IT IS AN OPPORTUNITY THAT
WE CURRENTLY HAVE IS WITH USE OF
APPLICATIONS WE CAN GET ACCESS
TO SOME OF THE BEHAVIORAL
TREATMENTS LIKE CONTINGENCY
MANAGEMENTS WAYS MUCH WIDESPREAD
THAN WE COULD IN THE PAST.
IN THAT RESPECT, THE GOOD NEWS
IS THAT NOW CONTINGENCY
MANAGEMENT IS GOING TO BE ABLE
TO INCREASE THE AMOUNT OF MONEY
THAT IS AUTHORIZED TO BE GIVEN
FROM $75 A YEAR TO $750, WILL
ALSO ENHANCE ITS EFFECTIVENESS.
BUT, YEAH, WE NEED TO LOOK INTO
IT AND LOOK INTO IT IN TERMS OF
PERSONALIZING THAT BEHAVIORAL
INTERVENTION.
>> THIS IS A TERRIFIC WAY TO
END.
WE HAVE OVER THE COURSE OF THE
NEXT TWO DAYS A LOT OF
ADDITIONAL RESEARCH THAT WE'RE
PLANNING FOR THE COMING YEAR AND
WE'LL ASK FOR YOUR INPUT ON THAT
WILL BE DISCUSSED IN CLOSED
SESSION, AND MANY PROJECTS WILL
SEEK TO TACKLE SOME OF THE
CHALLENGES WE JUST DISCUSSED BUT
THANK YOU TO EVERYONE FOR YOUR
THOUGHTS AND COMMENTS.
THIS ENDS THE OPEN SESSION OF
TODAY'S MEETING.