>>WELCOME TO THIS MEETING OF
HEAL, HELPING TO END ADDICTION
LONG-TERM INITIATIVES, MULTIDOSE
PLINARY WORKING GROUP MEETING.
I THINK SOME OF THE WORKING
GROUP MEMBERS AND MEMBERS OF THE
KEY NOTE COMMITTEE ARE
CONTINUING TO JOIN US.
SINCE IT'S NOW 11:00, I WILL
TURN IT OVER TO THE DIRECTOR
LARRY TABAK.
>> THANK YOU EVERYBODY, IT'S--
SINCE MARCH OF 2019, VERY
SHORTLY AFTER THE HEAL
INITIATIVE WAS LAUNCHED AND THE
GROUP HAS REALLILY BEEN
INSTRUMENTAL IN GUIDING THE
RESEARCH OR THIS AMBITIOUS AND
FRANKLY UNPRECEDENTED EFFORT TO
HELP STEM THE NATION'S OPIOID
CRISIS.
SINCE THE GROUP LAST MET IN
SEPTEMBER, WE HAVE REACHED AN
UNIMAGINABLE MILESTONE, IN THE
12 MONTH PERIOD, BEGINNING IN
MAY 2020, OVER 100,000 OVERDOSE
DEATHS.
HAS OCCURRED AGAINST THE BACK
DROP OF THE COVID-19 PANDEMIC
AND THE CONCOMITANT RISE OF
PREVALENCE IN FENTANYL IN THE
ILLICIT DRUG SUPPLY AND THESE 2
FACTORS IN THE RISE AND
POLYSUBSTANCE USE, THAT HAVE
MADE EFFORTS TO STEM THE OPIOID
CRISIS EVEN MORE CHALLENGE AND
AND EVEN MORE DEVASTATING TO
COMMITTEES IN EVERY CORNER OF
THE NATION.
AS YOU KNOW NIH IS PUTTING
FUNDING BEHINDS TO FIND NEW
APPROACHES TO BETTER PREVENT AND
TREAT OPIOID USE DISORDER AND
OVERDOSE, AND ENHANCE PAIN
MANAGEMENT.
FOLLOWING THE GUIDANCE AT THE
SEPTEMBER 21 MEETING, THE HEAL
INITIATIVE, HAS RELEASED THE
STRIKING NUMBER OF NEW FUNDING
ANNOUNCEMENTS IN NEW AREAS OF
THE RESEARCH THAT ADDRESS THIS
CHANGING LANDSCAPE OF THE OPIOID
CRISIS IN THE COMPLEXITY OF
CONCEPTS AND PROGRAMS AS WELL AS
LIMITATIONS OF CURRENT DATA
COLLECTION THAT HINDER OUR
ABILITY TO REALLY SEE WHAT'S
GOING ON IN COMMUNITIES IN THE
U.S.
WE ARE CERTAINLY LOOKING FORWARD
TO YOUR GUIDANCE OVER THE NEXT 2
DAYS.
TO INSURE NIH IS USING ALL
RESOURCES TO MOST EFFECTIVELY
SUPPORT THE BEST SCIENCE THAT
WILL HELP TURN THE TIDE IN THE
OPIOID CRISIS WHILE ALSO
PREPARING FOR WHAT WE HOPE ARE
SIGNIFICANT INCREASES TO THE
HEAL BUDGET BY CONGRESS FOR THIS
FISCAL YEAR.
OBVIOUSLY TO THAT, WE HAVE TO
STAY TUNED.
WE NEED YOUR THOUGHTFUL ADVICE
AND GUIDANCE TO MAKE SURE THAT
THE RESEARCH WE CONTINUE TO
INVEST IN, IS POSING THE RIGHT
QUESTIONS AND ADDRESSING THE
MOST PRESSING NEEDS AND
CONCERNS, SO WE WANT TO THANK
YOU FOR JOINING US FOR THESE 2
DAYS AND WE CERTAINLY LOOK
FORWARD TO A PRODUCTIVE
DISCUSSIONS ABOUT HOW WE CAN
BUILD UPON THE PROGRESS MADE
THUS FAR, BUT HOW WE MIGHT
INTENSIFY OUR EFFORTS GOING
FORWARD TO MEET THESE FORMIDABLE
CHALLENGES.
LET ME THANK THE EXECUTIVE
MEMBERS OF THE HEAL COMMITTEE
WHO PUT FORWARD FOR APPROVAL
WHAT THEY BELIEVE TO BE THE MOST
MERITORIOUS SCIENCE.
I WOULD LIKE TO GIVE A SHOUT OUT
IN PARTICULAR TO STAFF LED BY
REBECCA BAKER AND THE 6 WORKING
GROUPS WHO REALLY PUT IN AN
EXTRAORDINARY EFFORT TO GETITOUS
THIS POINT.
I THINK MOST OF YOU UNDERSTAND
THAT THESE ARE EFFORTS OVER AND
ABOVE YOU KNOW THEIR NORMAL
DUTIES IN THEIR HOME INSTITUTES
AND CENTERS.
I WOULD ALSO BE REMISS FIELD
FUNCTIONS DIDN'T ACKNOWLEDGE THE
WORK OF THE SCIENTIFIC TEAMS AND
THE PROGRAM OFFICERS WHO
COLLECTIVELY WORK TO GET 40 AND
COUNTING, FUNDING OPPORTUNITY
ANNOUNCEMENTS PUBLISHED SINCE
THE LAST MEETING, THE MBWG AND
THIS IS REALLY ASTONISHING AND
THEIR DEDICATION TO HEAL IS TO
BE COMMENDED.
I THINK WE NEED TO DO A QUICK
ROLL CALL TO CAPTURE WHO'S WITH
US TODAY.
SO IF I MAY, ERIN IF I CAN TURN
IT TO YOU TO DO THE ROLE CALL,
PLEASE?
>> CERTAINLY.
I'M HAPPY TO.
I WILL GO DOWN THE LIST OF THE
MULTIDISCIPLINARY GROUP MEMBERS
THAT I SEE.
SO CAN YOU JUST DO A QUICK CHECK
TO MAKE SURE YOUR VIDEO WORKS
AND SAY HELLO TO THE GROUP.
SO START ON TOP HERE, SO I SEE
DR. ANDRIEA JONES, DO YOU WANT
TO SAY HELLO.
>> HI, GOOD MORNINGS, THANKS FOR
HAVING ME.
>> GREAT.
>> HELLO.
>> DR. WISNER.
>> I'M VERY SORRY, I'M HERE I
JUST DIDN'T UNMUTE.
>> PERFECT.
HELLO.
UPON.
>> DR. [INDISCERNIBLE]
>> YES, GOOD MORNING.
>> HELLO.
DR. SMITH.
>> HEY, WALLY SMITH HERE.
>> GOOD TO SEE YOU, DR. JARREAU?
>> GOOD MORNING ALL, GOOD TO SEE
YOU ALL.
>> DR. BOSSBAUM.
>> GOOD MORNING EVERYONE.
>> HELLO, THANKS FOR JOINING,
DR. HARRIS.
>> GOOD MORNING EVERYONE.
>> I ALSO SEE DR. DEBARN.
>> GOOD MORNING NICE TO SEE
EVERYBODY.
AND I THINK I CAUGHT EVERYONE ON
THIS LIST BUT IF I MISSED YOU,
PLEASE FEEL FREE TO OPEN UP YOUR
CAMERA AND SAY HELLO.
>> HI, CHRIS HERE, GOOD MORNING.
>> HELLO, GOOD MORNING.
>> CONNIE WISENER SAYING HI.
>> WE SEE YOU THANKS, CONNIE.
DID EMPLOY.
>> LET ME JUST REAL QUICKLY THEN
GO THROUGH THE LIST OF THE HEAL
EXECUTIVE COMMITTEE MEMBERS I
SEE AS WELL.
YOU CAN SAY HELLO BUT LET ME
JUST RUN THROUGH WHO I SEE.
SO I SEE DR. KOROSHETKRYSTEN
ANDERSON.
>> DR. RUNNER, DR. CRISWELL, AND
I BELIEVE THAT IS THE LIST
JOINING US RIGHT NOW ALTHOUGH
MULTIPLE OTHER MEMBERS WILL BE
COMING IN OUT OF THE MEETING.
>> AND I THINK DR. LANGEVIN,
TOO.
>> THANK YOU SO MUCH, AGAIN, AND
WELCOME EVERYBODY.
LET'S GO QUICKLY THROUGH THE RUN
OF SHOW, IN A BIT YOU WILL HEAR
FROM DR. BAKER ABOUT THE HEAL
PORTFOLIO AND PROGRAMS AND I
HOPE YOU WILL FIND THAT TO BE
VERY INTERESTING.
AND THIS WILL BE FOLLOWED BY A
DISCUSSION PERIOD WHERE WE HOPE
YOU WILL REFLECT ON WHAT YOU'VE
HEARD ABOUT THE PORTFOLIO.
THEN YOU WILL HEAR FROM
DR. NORA VOLKOW, DIRECTOR OF
NIDA, AND DR. WALTER KOROSHETZ,
FROM NINDS, EMERGING ISSUES IN
OPIOID CRISIS, FOLLOWED BY
DISCUSSION, AGAIN, THE EMSIS IS
WE WANT TO HEAR FEEDBACK FROM
YOU.
THERE WILL BE A BREAK AT 12:30
AND THEN AT 12:45, THERE WILL BE
A RETURN FOR THE CLOSED SESSION
TO DISCUSS NEW RESEARCH CONCEPTS
FOR THE UPCOMING FISCAL YEAR
THAT STARTS ON OCTOBER 1st.
SO THAT'S THE 2023 BUDGET AND OF
COURSE, WE ARE AWARE THAT WE ARE
STILL ADJUDICATING WHAT WE HOPE
WILL BE A BUDGET FOR 2022.
BUT THIS IS--THIS IS THE WAY
THINGS WORK.
AND YOU WILL ALSO HEAR
ADDITIONAL UPDATES FROM REBECCA
ABOUT HEAL EFFORTS TO BUILD AND
ENHANCE THE RESEARCH WORKFORCE
AND PROGRESS TO DATE IN THE
DEVELOPMENT OF THE HEAL DATA
PLATFORM AND SHE WILL ALSO LET
YOU KNOW ABOUT THE UPCOMING HEAL
INVESTIGATOR MEETING WHICH WILL
BE TAKING PLACE VIRTUALLY ON
OCTOBER 11th AND 12th.
SO JUST TO CONCLUDE, TO GET US
OFF TO THE ESSENCE OF THE
PROGRAM, I WANT TO AGAIN THANK
YOU ALL FOR YOUR WILLINGNESS TO
BE HERE TODAY, TO GIVE US THE
TYPE OF ADVICE THAT WE REALLY
NEED TO DEPEND UPON AS WE SEEK
TO BUILD AREAS THAT ARE REALLY
READY FOR PROGRESS AND OF
COURSE, THE SAME TIME
AGGRESSIVELY RESPOND TO AN EVER
EVOLVING CRISIS WITH THE GOAL OF
COURSE, THE SHARED GOAL OF
REVERSING THE DISTURBING AND
QUITE TRAGIC TRENDS THAT WE ARE
SEEING.
SO THANK YOU AND I WILL TURN IT
OVER TO DR. REBECCA BAKER WHO IS
THE DIRECTOR OF THE NIH HEAL
INITIATIVE.
REBECCA?
>> THANK YOU DR. TABAK, AND
THANK YOU EVERYONE FOR COMING
AND JOINING US TODAY, BOTH THOSE
WHO WE JUST WENT THROUGH YOUR
NAMES ON THE EXECUTIVE COMMITTEE
AND MULTIDISCIPLINARY WORKING
GROUP AND ALSO THOSE OF YOU WHO
ARE WATCHING THE VIDEOCAST, VERY
PLEASED TO SHARE WITH YOU SOME
OF THE PROGRESS, THE HEAL
INITIATIVE HAS MADE OVER THE
PAST YEAR.
THIS SPRING MEETING IS OFTEN
WHEN WE LOOK BACK AND REFLECT ON
WHAT WE'VE DONE.
I WILL SAY, THIS NOW MARKS 2
YEARS SINCE WE'VE BEEN DOING
THIS INITIALLY AND EVEN THOUGH
WE HAVE NOT BEEN TOGETHER, THE
COLLECTIVE TEAMS IN THE HILL
COMMUNITY HAVE DONE A TREMENDOUS
AMOUNT OF WORK VERY PROUD OF THE
ACTIVITIES AND ACCOMPLISHMENTS
AND I WILL TRY TO RUN THROUGH
THEM QUICKLY BUT YOU WILL HEAR
ABOUT THEM IN MORE DETAIL AS THE
MEETING GOES ON FROM THE CO
CHAIRS OF THE HEAL SCIENTIFIC
TEAMS.
SO NEXT SLIDE, PLEASE.
--OVERDOSE CONTINUES TO
DEVASTATE COMMUNITIES ACROSS THE
COUNTRY.
IT HAS NOT GONE AWAY DURING
COVID, IT HAS ACTUALLY GOTTEN
WORSE DESPITE OUR RESEARCH AND
POLICY EFFORTS.
THERE WAS A 20% IN CREASE IN
FATAL DRUG OVERDOSES, THAT'S ALL
DRUG OVERDOSES IN THE LAST 12
MONTH PERIOD FOR WHICH WE HAVE
GOOD DATA AND THOSE THAT ARE
LIVES THAT ARE IMPORTANT TO US
AND THOSE ARE DEATH THAT ARE
PREVENTIBLE AND YET WE ARE
STRUGGLING TO USE OUR RESEARCH
AND OUR COMMUNITIES TO PULL
TOGETHER AND PREVENT THESE
DEATHS.
AS YOU HEARD FROM DR. TABAK,
THERE ARE POWERFUL TRENDS THAT
ARE DRIVING OVERDOSE AND USE
PATTERNS IN THE UNITED STATES
INCLUDING THE RISE OF SYNTHETIC
OPIOIDS LIKE FENTANYL AND THE
USE OF MORE THAN 1 SUBSTANCE.
INCLUDING BUT NOT LIMITED TO
OPIOIDS.
THE MAJORITY OF THESE OVERDOSE
DEATHS ARE ASSOCIATED WITH
OPIOIDS BUT NOT ALL OF THEM AND
RISE IN THE USE OF STIMULANTS IS
PUTTING A LOT MORE PEOPLE AT
RISK.
AND THEN, IT'S ALSO IMPORTANT TO
ACKNOWLEDGE THAT THE DEATHS ARE
JUST THE TIP OF THE ICEBERG.
WE HAVE A LOT OF AMERICANS WHO
MISUSE OPIOIDS OR HAVE AN OPIOID
USE DISORDER WHO DO NOT HAVE
ACCESS TO HIGH QUALITY CARE AND
DON'T HAVE TREATMENTS AVAILABLE
THAT WORK FOR THEM.
AND COLLECTIVELY, THIS IS
DRIVING US TO LOOK AT WHAT WE
CAN DO AS RESEARCH COMMUNITY AND
PULL TOGETHER A REALLY ROBUST
AND DIVERSE PORTFOLIO OF EFFORTS
TO ADDRESS THIS CRISIS.
AND WE WOULD NOT BE ABLE TO
PROVIDE LASTING AND DURABLE
SOLUTIONS TO THE NATIONAL OPIOID
CRISIS IF WE WERE NOT ABLE
TO--IF WE ARE NOT ABLE TO
ADDRESS THE NEEDS OF THE
MILLIONS OF AMERICANS WHO
EXPERIENCE PAIN.
SO THE NEXT SLIDE SHOWS, JUST
HOW MANY AMERICANS THIS IS,
50 MILLION AMERICAN ADULTS
EXPERIENCE CHRONIC PAIN, ABOUT
HALF OF THEM EXPERIENCE SEVERE
PAIN EVERY DAY.
20 MILLION HAVE SUCH CHRONIC
PAIN THAT THEY'RE NOT ABLE TO
CARRY OUT FUNCTIONS THAT GIVE
THEIR LIFE MEANING AND AND WE
HAVE ALL OF THESE--WE HAVE
LIMITED THERAPEUTIC OPTIONS FOR
PEOPLE WITH PAIN AND SO, THESE
PATIENTS ARE EXPOSED TO RISKS
ASSOCIATED WITH OPIOIDS AND FACE
CHALLENGES TO OBTAINING HIGH
QUALITY EFFECTIVE
MULTIDISCIPLINARY PAIN
MANAGEMENT THAT THEY NEED.
SO IN THE NEXT SLIDE ... WE
STARTED THE HEAL INITIATIVE,
HELPING TO END ADDICTION
LONG-TERM, LIKE THE CRISIS IS
LARGE IN SCOPE AND SCALE.
WE'VE NOW SPENT OVER 2 BILLION
DOLLARS IN RESEARCH ACROSS 600
DIFFERENT PROJECTINGS, LARGE
NUMBER OF NEWLY LAUNCHED
PROGRAMS ACROSS ALL 50 STATES
AND A LARGE NUMBER OF FUNDING
OPPORTUNITY ANNOUNCEMENT VS COME
THROUGH TARGETING SPECIFIC AREAS
OF NEED FOR RESEARCH TO ADDRESS
THE CRISIS, 30 OF THESE ARE NOW
OPEN, SO IF YOU ARE TUNING IN
AND YOU'RE INTERESTED IN BEING
PART OF HEAL, PLEASE GO TO OUR
WEBSITE AND SEE THE OPEN FUNDING
OPPORTUNITIES AND LOOK FOR
SOMETHING THAT MIGHT BE A MATCH
FOR YOU BECAUSE THE NUMBER OF
DIFFERENT TYPES OF RESEARCH THAT
WE ARE FUNDING IS EXTREMELY
LARGE AND IT'S BROAD.
SO WE REFLECTING THE COMPLEXITY
OF THE CRISIS, WE HAVE
PREVENTION RESEARCH, WE HAVE
BASIC AND TRANSLATIONAL SCIENCE
TRYING TO COME UP WITH NEW
THERAPEUTIC OPTIONS.
A LARGE NUMBER OF CLINICAL
TRIALS, TESTING SPECIFIC
INTERVENTIONS FOR PAIN AND
ADDICTION AND SPECIFIC
POPULATIONS AND IN SPECIFIC
SETTINGS, TRYING TO INFORM THE
BEST TREATMENT FOR THE
POPULATIONS WE SERVE.
AND THEN LASTLY, A FOCUS ON
IMPLEMENTATION SCIENCE.
HOW DO WE TAKE THE
EVIDENCE-BASED INTERVENTIONS AND
KNOWLEDGE THAT WE HAVE AND
CONVERT THAT INTO TREATMENTS AND
APPROACHES THAT WORK FOR PEOPLE.
SO HERE ON YOUR RIGHT IS THE
DIAGRAM OF THE DIFFERENT
RESEARCH FOCUS AREAS WITHIN
HEAL.
THIS WILL BE OUR MAP FOR TODAY.
YOU WILL HEAR FROM THE
LEADERSHIP OF EACH OF THE
SCIENTIFIC TEAMS REFLECTING
THESE RESEARCH FOCUS AREAS BUT
BEFORE THAT, I WILL GO THROUGH
EACH 1 AND BRIEFLY DESCRIBE NOT
ONLY WHAT RESEARCH IS TAKING ON,
BUT ALSO SOME OF THE NEW
DIRECTIONS THAT WE'VE LAUNCHED
IN THE PAST YEAR OR 2 AS WE'VE
BEEN SO INCREDIBLY ACTIVE.
SO NEXT SLIDE, PLEASE.
THE FIRST AREA OF RESEARCH FOCUS
IS PRECLINICAL AND TRANSLATIONAL
RESEARCH IN PAIN MANAGEMENT.
THIS IS OUR EFFORT TO COME UP
WITH NEW TARGETS, NEW
THERAPEUTIC OPTIONS, NEW DEVICES
AND APPROACHES FOR MANAGING PAIN
THAT ARE NOT ADDICTIVE.
SO THIS INCORPORATES A NUMBER OF
DIFFERENT REALLY INNOVATIVE
STUDIES THAT ARE BEGINNING TO
BEAR FRUIT INCLUDING PATENTS AND
INDs FOR NOVEL CANDIDATES TO
TREAT CHRONIC PAIN BUT ALSO A
LOT OF RESEARCH PROGRESS IN THE
MODELS AND SYSTEMS WE CAN USE TO
AS A COLLECTIVE ADVANCE
THERAPEUTIC OPTIONS THROUGH THE
PIPELINE.
I'M REALLY WORKING TO INCREASE
TEAM BASED RESEARCH, SO THAT
INNOVATIVE AND PROMISING
CANDIDATES DON'T GET LOST FROM 1
SET TO THE NEXT.
AND THE NEXT SLIDE.
YOU CAN SEE SOME OF THE ADVANCES
IN THIS WORKING SPACE, THE
WORKING GROUP GAVE A LOT OF
FEEDBACK THAT LED TO A NEW AND
EXPANDED ANALGESIC THERAPEUTIC
DEVELOPMENT PROGRAM, BOTH
PLANNING STUDIES AND MORE LARGE
SCALE PHASED ASHES WARDS TO
ADVANCE THERAPEUTIC OPTIONS FOR
TREATING PAIN AND THEN PLANNED
FOR THIS COMING YEAR, FY22 AND
I'M ALSO THINKING OF A FISCAL
YEAR HERE, WHEN IT SAYS 22,
INCREASED RESEARCH IN DEVICES TO
TREAT PATIENT, WAYS TO STUDY AND
UNDERSTAND PAIN, NOT IN ANIMAL
MODELS BUT IN HUMAN GENES
THEMSELVES.
A FOCUS ON JOINTS THROUGH THE
REJOIN PROGRAM AND A NUMBER OF
AWARDS FOR EARLY STAGE
INVESTIGATORS AND INNOVATIVE
APPROACHES INCLUDING THE HEAL
INNOVATOR AWARDS.
I WILL NOW MOVE TO CLINICAL
RESEARCH AND PAIN MANAGEMENT.
NEXT SLIDE.
WHERE OUR SCIENTIFIC EXPERTS
SEEK TO PROVIDE INFORMATION TO
CLINICIANS AND PATIENTS AND
CAREGIVERS ABOUT WHAT THERAPIES
AND TREATMENT APPROACHES WORK
BEST FOR SPECIFIC PAIN
CONDITIONS AND IN SPECIFIC
SETTINGS.
THERE'S A LARGE NUMBER OF
CLINICAL TRIALS UNDERWAY IN THIS
AREA OF RESEARCH FOCUS.
SOME FOCUSED ON SPECIFIC PAIN
CONDITIONS FOR WHICH WE KNOW WE
MIGHT PUT A LOT OF PEOPLE AT
RISK FOR OPIOIDS SUCH AS
MUSCULOSKELETAL PAIN CONDITIONS,
CHRONIC LOW BACK PAIN BUT ALSO
PROGRAMS THAT ARE PRETTY
AGNOSTIC TO THE PAIN CONDITION
BUT ARE LOOKING TO COMPARE 1
TREATMENT VERSUS ANOTHER OR
INTEGRATE INTO HEALTHCARE
SYSTEMS, EVIDENCE-BASED
TREATMENTS FOR A SPECIFIC PAIN
CONDITIONS.
ALL OF THESE ARE USING A CORE
SET OF COMMON DATA ELEMENTS SO
THAT RESEARCH CAN BE COMPARED
ACROSS THE DIFFERENT PROGRAMS
AND IN THE NEXT SLIDE CAN SEE
WE'RE ALSO REALLY TRYING TO
FECUS ON AREAS WHERE ADDITIONAL
WORK IS NEEDED SO THE EMPOWER
PROGRAM OF WHICH I'M REALLY
PROUD AND WHICH WAS LAUNCHED
WITH A LOT OF INPUT FROM THIS
MULTIDISCIPLINARY WORKING GROUP
SEEKS TO ADDRESS CHRONIC PAIN
AMONG PEOPLE WITH OPIOID USE
DISORDER OR A HISTORY OF OPIOID
USE DISORDER FOR WHOM OPIOIDS
ARE REALLY NOT GOOD CANDIDATES
FOR PAIN MANAGEMENT AND THEN
ALSO A REALLY SIGNIFICANT EFFORT
TO FOCUS ON HEALTH EQUITY AND
HEALTH DISPARITIES WHICH REALLY
KEEP A LOT OF PEOPLE FROM
ACCESSING HIGH QUALITY PAIN CARE
THAT THEY NEED.
AND THAT INCLUDES EFFORTS TO
ADDRESS BIAS, STIGMA AND OTHER
BARRIERS TO HIGH QUALITY PAIN
CARE.
>> LOOKING FORWARD, WE HAVE
ADDITIONAL BIOMARKERS EFFORTS IN
THE PLANNING STAGES AS WELL AS
EFFORTS TO ENHANCE THE PAIN
RESEARCH WORKFORCE AND A LOT OF
DIFFERENT DIMENSIONS AND ALSO
START USING SOME OF THE DATA
TOOLS THAT WE HAVE TO LOOK OVER
EXISTING DATA SETS AND COME UP
WITH NEW INSIGHTS AND NEW
SCIENTIFIC SOLUTIONS FOR
UNDERSTANDING AND TREATING PAIN.
SO THOSE ARE THE 2 AREAS OF
RESEARCH FOCUS ON THE ENHANCING
PAIN MANAGEMENT SIDE, I WILL NOW
MOVE TO RESEARCH TO IMPROVE
TREATMENTS AND PREVENTION
STRATEGIES FOR OPIOID USE AND
ADDICTION.
IN THE PREVENTION SPACE, THIS IS
SO IMPORTANT TO NOT WAIT UNTIL A
PERSON HAS A CLINICAL OPIOID USE
DISORDER BUT TO INTERVENE AND
PREVENT THE DEVELOPMENT OF
OPIOID USE AND ADDICTION, WE DO
THAT BY FOCUSING ON CERTAIN AT
RISK GROUPS LIKE YOUNG ADULGTS
AND PEOPLE IN POPULATIONS LIKE
AMERICAN INDIAN AND ALASKA INN
NATIVES ALSO USING TOOLS AND ALL
OF THEA SPECTS THAT CONTRIBUTE
TO A PERSON'S SLEEP DISORDER
INCLUDING SLEEP, CIRCADIAN
RHYTHM AND MENTAL HEALTH
CONDITIONS.
>> OT NEXT SLIDE, CAN YOU SEE
MANY AREAS OF NEW RESEARCH LED
BY THIS SCIENTIFIC TEAM.
SO SERVICE DELIVERY
INTERVENTIONS FOR OPIOID USE
DISORDER AND MENTAL HEALTH
CONDITIONS, ESPECIALLY THOSE
THAT FOCUS ON PRIMARY CARE.
AND THEN A NUMBER OF UPON
STUDIES ARE INCLUDED FOR 2022
INCLUDING WAYS FOR POLYSUBSTANCE
USE, WAYS TO BETTER SCREEN
INDIVIDUALS FOR OPIOID USE
DISORDER AND WAYS TO INTERVENE
ON SOCIAL DETERMINANTS OF HEALTH
TO PREVENT OPILOT PROJECTIE USE
PROGRESSION AND PREVENT MISUSE
FOR OPIOID DISORDER.
SO AS YOU CAN SEE A REALLY NEW
SET OF ROBUST PLANS ARE UNDERWAY
IN THIS SPACE.
IN THE NEXT SLIDE, WE ADDRESS
THE NEED OF THE MANY, MANY
PEOPLE WITH OPOID USE DISORDER
WHO NEVER RECEIVE APPROPRIATE
TREATMENT FOR THEIR CONDITION.
IT'S REALLY A MINORITY OF
PATIENT WHO IS RECEIVE
APPROPRIATE TREATMENT AND SO, WE
SEEK TO TAKE THE EVIDENCE-BASED
INTERVENTIONS AND PREVENTION
STRATEGIES THAT WE HAVE AND PUT
THEM INTO THE HANDS OF PEOPLE
AND SETTINGS WHERE PEOPLE WITH
ADDICTION COME SEEKING HELP, SO
THAT CAN BE A COMMUNITY SETTING,
PRIMARY CARE SETTING AND A LOT
OF TERRIFIC PROGRESS HAS BEEN
UNDERWAY IN THESE GROUPS
ESPECIALLY IN SPECIFIC DOMAINS
LIKE EDUCATING PEOPLE FOR THE
USE OF NOLOXONE FOR OVERDOSE AND
LOOKING AT THESE COMMUNITIES AND
SPECIFIC STAKEHOLDERS, SPECIFIC
PLACES WHERE THEY CAN WILL IT
US, HERE'S WHAT WE NEED, HERE'S
INFORMATION THAT'S GOING TO MAKE
A CHANGE FOR US AND FOR THE
PEOPLE WE SERVE AND WORKING IN
PARTNERSHIP TO DO SO.
AND IN THE NEXT SLIDE, YOU SEE
SOME OF THE DIRECTIONS WE'RE
MOVING INCLUDING AN ADDITIONAL
INVESTMENT AND INVESTMENT
RECOVERY RESEARCH, WAYS TO
UNDERSTAND HARM REDUCTION
STRATEGIES BOTH HOW THEY MIGHT
AFFECT BEHAVIOR CHANGE AND ALSO
OPPORTUNITIES FOR INNOVATION AND
THEN A NUMBER OF DATA FOCUSED
EFFORTS SEEKING TO GIVE OUR
STAKEHOLDERS THE DATA THEY NEED
AND PROVIDING THEM WITH
INFRASTRUCTURE AND TOOLS TO
ADOPT THE RESEARCH FINDINGS THAT
COME OUT OF THE HEAL INITIATIVE
AND THAT MIGHT EVEN BE AVAILABLE
TO THEM IN THEIR LOCAL
COMMUNITIES.
>> SO THAT'S THE AREA OF
IMPLEMENTATION SCIENCE WHERE WE
SEEK TO TRANSLATE THE RESEARCH
INTO PRACTICE, AND IN THE NEXT
SLIDE, THE NOVEL THERAPEUTIC
OPTIONS AREA OF RESEARCH FOCUS
SEEKS TO ADDRESS THE NEEDS OF
PEOPLE WHO DO RECEIVE SOME KIND
OF TREATMENT FOR OPIOID USE
DISORDER BUT WHO ARE NOT ABLE TO
STAY ON IT LONG ENOUGH TO
ACHIEVE LONG-TERM RECOVERY OR
OTHER MINORITY.
SO FOR THIS GROUP WE'RE POSTING
THE QUESTION WELL WHAT
ADDITIONAL THERAPEUTIC OPTIONS
MIGHT MAKE IT EASIER FOR A
PERSON TO STAY ON TREATMENT AND
MAKE IT MORE LIKELY FOR A PERSON
TO ENTER LONG-TERM RECOVERY AND
SO THAT IS ENCOMPASSES A LARGE
NUMBER OF THERAPEUTIC PROGRAMS,
BOTH APPROACHES TO MAKE LONGER
LASTING OR MORE USER FRIENDLY
VERSION OF THE MEDICATIONS AND
THERAPEUTIC TREATMENTS WE
ALREADY HAVE AND THAT EFFORT HAS
LED TO OVER 20 I& Ds SINCE
HEAL IPT GREATER LAUNCHED BUT
ALSO NEW INVOCABULARYIVATIVE
APPROACHES.
NEW WAYS OF THINKING ABOUT
ADDICTION AND HOW IT'S TREATED
SO INCORPORATING SLEEP OUTCOMES
AND OTHER MECHANISMS OF TREATING
OPIOID USE DISORDER AND ALSO
MODALITIES INCLUDING THE FIRST
HUMAN STUDY OF A VACCINE FOR
OPIOIDS.
AND SOME DEVICES AS WELL.
SO IN THE NEXT SLIDE, YOU CAN
SEE HOW THIS RESEARCH IS MOVING
INTO UNDERSTANDING MEDICATIONS
AND THERAPEUTIC TREATMENTS FOR
POLYSUBSTANCE USE AND INCLUDING
THE USE OF STIMULANTS AND THAT
INCLUDES NOT JUST PHARMA CO
THERAPIES FOR OPIOID USE
DISORDER BUT ALSO TO REVERSE
OVERDOSE AND ALSO SOME DIGITAL
THERAPEUTICS RECOGNIZING THAT
ESPECIALLY IN THESE VIRTUAL
DAYS, FOLKS ARE ON THEIR PHONES
AND THERE MAY BE MODALITIES THAT
WE HAVE NOT TESTED THAT COULD BE
EFFECTIVE FOR TREATING OPIOID
USE DISORDER IN THE CONTEXT OF
THE USE OF OTHER SUBSTANCES AS
WELL.
>> NOW IN THE LAST AREA OF
RESEARCH FOCUS, WE KNOW THAT
OPIOID USE DOESN'T JUST AFFECT
THE PERSON WHO USES IT, IT
AFFECTS THEIR FAMILIES AND
COMMUNITIES.
AND FOR INSTANTS THERE CAN BE
EXTREME CONSEQUENCES OF BEING
EXPOSED TO OPIOIDS DURING A
MOTHER'S PREGNANCY SO 2 PROGRAMS
WITHIN THE HEAL INITIATIVE, THE
ACT NOW ADVANCING CLINICAL
TRIALS IN NEONATAL O, PILOT
PROJECTOID WITHDRAWAL PROGRAM
SEEKS TO UNDERSTAND HOW TO BEST
TREAT THESE INFANTS, AND THEN
THE HEALTHY BRAIN AND CHILD
DEVELOPMENT STUDY OR HBCD, SEEKS
TO UNDERSTAND WHAT THE
CONSEQUENCES ARE FOR THESE
EXPOSURES OVER THE LONG-TERM,
TAKING INTO CONSIDERATION ALL
THE OTHER ENVIRONMENTAL AND
OTHER CONTRIBUTORS TO A CHILD'S
BRAIN AND OVERALL DEVELOPMENT.
SO IN THE NEXT SLIDE, CAN YOU
SEE HOW WE--I'M VERY PROUD TO
SAYEE LAUNCHED THE HEALTHY BRAIN
AND CHILD DEVELOPMENT STUDY IN
2021 AND ARE NOW IN THE PLANNING
STAGES FOR COMPARATIVE
EFFECTIVENESS TRIAL,
UNDERSTANDING THE BEST WAY TO
TREAT INFANTS WITH ANALYSIS, AND
HAVE SOME WAYS OF ENHANCING AND
STRENGTHENING THOSE PROGRAMS
THROUGH SOME NAVIGATOR SUPPORT
UNDERWAY AS WELL.
SO THAT IS IT FOR THE AREAS OF
THE 6 RESEARCH FOCUS AREAS BUT
THERE ARE SOME CROSS CUTTING
ELEMENTS THAT REALLY EFFECT ALL
OF OUR RESEARCH.
THE FIRST IS THE NEED TO
INTEGRATE THE STRENGTHENS AND
CAPABILITIES OF UNDERSTANDINGS
OF PAIN AND OPIOID USE DISORDER
RESEARCH THAT HAS BEEN A THEME
THAT WE'VE HEARD FROM YOU SINCE
WE FIRST STARTED AND HAS REALLY
COME OUT OF OUR RESEARCH
COMMUNITIES AND STAKEHOLDERS AS
WELL.
ACROSS ALL OF THIS RESEARCH, WE
CONTINUE TO PRESS TO ENHANCE
HEALTH EQUITY TO INCREASE THE
DIVERSITY OF THE RESEARCH
PARTICIPANTS INVOLVED IN OUR
STUDIES AND TO UNDERSTAND WHAT
RESEARCH CAN DO TO ADDRESS THESE
INIQUITIES.
PART OF THAT INVOLVES THE
PARTNERSHIP WITH PEOPLE'S LIVED
EXPERIENCE.
WE'VE NOW BEEN ABLE TO STAND UP
A GROUP OF INDIVIDUALS WITH
LIVED EXPERIENCE AND PAIN AND
ADDICTION WHO ADVISE THE HEAL
INITIATIVE AND ALSO WORK WITH
THE SCIENTISTS ON THE INDIVIDUAL
HEAL PROGRAMS AND I WILL TELL
YOU MORE ABOUT THAT LATER IN
THE--LATER IN TODAY'S MEETING.
A REAL NEED FOR DISSEMINATION
AND SHARING OF RESEARCH FINDINGS
WITH THE SCIENTIFIC COMMUNITY
BUT ALSO BEYOND TO OUR DIFFERENT
STAKEHOLDER POLICY MAKER, AND
PATIENT AND CAREGIVER PARTNERS
AND I'M ALSO GOING TO NEED TO
ADAPT TO THE HISTORIC COVID
PANDEMIC.
OUR SCIENTIST VS REALLY MADE
SIGNIFICANT CHANGES TO THEIR
STUDIES IN ORDER TO CONTINUE TO
CARRY THEM OUT AND NOT SPEND
ACROSS THE BOARD, ALTHOUGH
DIFFERENT IN EACH AREA OF
RESEARCH FOCUS.
YOU CAN LEARN MORE ABOUT SOME OF
THE AREAS OF PROGRESS IN THE
HEAL INITIATIVE THROUGH OUR
ANNUAL REPORT.
WE HAVE 1 THAT CAME OUT LAST
YEAR AND A NEW 1 IS EXPECTED TO
COME OUT SOON.
SO, NEXT, SLIDE, PLEASE.
I'LL NOW MOVE ON TO A SUMMARY OF
OUR CURRENT ACTIVITY AND FUTURE
DIRECTION, SETTING US UP FOR THE
REST OF TODAY'S MEETING.
NEXT SLIDE.
AS DR. TABAK, ALLUDED, WE DO NOT
HAVE AN APPROPRIATION FOR THE
FISCAL YEAR 2022, THAT'S WHEREY
WOO ARE RIGHT NOW.
SO WE'RE FORTUNATE IN THAT THE
PRESIDENT REQUESTED A
SUBSTANTIAL INCREASE IN THE
BUDGET FOR THE HEAL INITIATIVE,
A 50% INCREASE THAT IS ACTUALLY
PART OF A LARGER AND ACROSS THE
NIH PROPOSED INCREASE BUT WE DO
NOT YET HAVE A BILL PASSED BY
CONGRESS SO WHAT WE'VE BEEN
DOING IS PLANNING, THE MANY
DIFFERENT WAYS THAT WE COULD USE
THOSE RESOURCES TO STRENGTHEN
THE RESEARCH EFFORTS WE HAVE
UNDERWAY IN THE INITIATIVE AND
BUILD INTO AREAS OF URGENT NEED,
AND WE ARE NOW BEGINNING TO
CONDUCT A SIMILAR UPON ANALYSIS
AND PLANNING PROCESS FOR FY2023
AND THAT WILL BE A LOT OF WHAT
WE ASKED THE GROUP TO GIVE US
ADVICE ON IN THE NEXT 2 DAYS.
WHAT ARE THE GREATEST AREAS OF
OPPORTUNITY FOR THE COMING YEAR,
TAKING INTO CONSIDERATION ALL
THAT WE'VE FUNDED, ALREADY AND
ALL THAT WE'VE PLANNED FOR THIS
YEAR.
SO, NEXT SLIDE, PLEASE.
THIS IS A COLLECTION OF THE MANY
RESEARCH EFFORTS, I SAID THAT
THERE WERE OVER 40 I THINK THAT
WERE LAUNCHED IN 2022.
MANY OF THESE ALIGN WITH THE HHS
OVERDOSE PREVENTION STRATEGY
THAT FOCUSES ON PREVENTION,
TREATMENT, HOME REDUCTION AND
RECOVERY SUPPORT SERVICES.
SO HEAL HAS MADE AND OUR
SCIENTIFIC TEAMS HAVE WORKED
HARD TO MAKE SURE THAT THE
RESEARCH WE SUPPORT ALIGNS WITH
AND ADVANCES THE DEPARTMENT'S
GOALS IN PREVENTING OVERDOSE AND
OVERDOSE STAFF, AND YOU WILL SEE
THE TEAMS REFLECT ON EACH OF
THESE NEW PRIORITIES, AND
RESEARCH PROGRAMS OVER THE
COURSE OF THE 2 DAY MEETING.
NEXT SLIDE.
AND HEARING SOME OF THE AREAS
YOU WILL HEAR MORE ABOUT FOR
FY2023, SOME SIMILAR BUT A LOT
OF NEW DOMAIN AREAS THAT WERE
WORKING TO ADDRESS AND THEN, IN
THE NEXT SLIDE, I SAY THANK YOU
TO THE MANY PARTNERS THAT WE
HAVE ACROSS THE HEAL INITIATIVE
AT NIH, FIRST, THE SCIENTIFIC
TEAMS, WE HAVE 6 SCIENTIFIC
TEAMS EACH WITH 2 CO-CHAIRS,
TOGETHER THESE TEAMS REPRESENT
ALL OF OUR 200 NIH PROGRAM
STAFF.
TWENTY OF THE INSTITUTES CENTERS
AND OFFICES AT NIH ARE REALLY
BROAD COLLECTION OF EXPERTISE
AND KNOWLEDGE TO RAPIDLY CONVERT
THE GOOD IDEAS, COMING FROM YOU
ALL AND OUR BROADER COMMUNITY
INTO DISCREET RESEARCH
OPPORTUNITIES AND PROGRAMS FOR
THE HEAL INITIATIVE.
AND THEN OF COURSE, IN THE NEXT
SLIDE, THE HEAL EXECUTIVE
COMMITTEE, THANK YOU VERY MUCH
FOR YOUR LEADERSHIP AND FOR YOUR
COLLECTIVE GUIDANCE AND GOOD
IDEAS FOR RESEARCH TO BE CARRIED
OUT THROUGH THE INITIATIVE.
SO WITH THAT, I WILL PAUSE AND
ASK IF THERE ARE ANY QUESTIONS
OR WE CAN START A DISCUSSION.
YOU CAN GO TO THE NEXT SLIDE.
THANK YOU.
>> I DID HAVE 1 QUICK QUESTION,
THIS IS LYNN.
I AM JUST CURIOUS, WHEN YOU
WERE--WHEN YOU WERE GOING
THROUGH SOME OF THE LARGER SCALE
SUBINITIATIVES AMONG THE
CLINICAL TRIALS, I KNOW THAT
PRISM AND THE PAIN ERN, HAVE
CONTINUED TO PUT OUT
ANNOUNCEMENTS AND YOU KNOW
THEY'RE AN ONGOING ENTERPRISE,
RIGHT?
IT'S AN INFRASTRUCTURE THAT'S
BEEN WONDERFUL AND HELPED AND
SUPPORTED THOSE PROJECTS IS THE
SAME THING EXPECT WIDE EMPOWER?
I WAS JUST CURIOUS, THE WAY IT
WAS PUT UP THERE, I WAS THINKING
IT'S MORE OF A 1 TIME INITIATIVE
BUT IS THAT EXPECTED TO CONTINUE
ON IN A SIMILAR SORT OF FASHION.
>> GREAT, QUESTION.
THANKS LYNN.
IT'S NICE TO SEE YOU.
SO, 1 OF THE SPECIAL THINGS
ABOUT BOTH THE PRISM PROGRAM
WHICH LEVERAGES THE
INFRASTRUCTURE OF THE NIH
HEALTHCARE RESEARCH SYSTEMS
COLLAB RATORSKPE BAKUGAN
EFFECTIVENESS RESEARCH NETWORK
WHICH LEVERAGES THE STRENGTHS OF
THE CTSA, AND THE TRIALS
INNOVATION NETWORKS AT NCATS IS
THAT THEY HAVE THIS BASE AND SO
WE CAN CONTINUE TO LAYER ON NEW
TRIAL, NEW TRIAL, WE CAN SAY,
OKAY, WELL WE HAVE A LOT AND
THERE'S SOME THAT WOULD STILL
LIKE TO UNDERSTAND
PHARMAICOLOGICAL TREATMENT OR
PEDIATRIC PAIN MANAGEMENT AND
THEN WE CAN ADD TRIALS THROUGH
THAT NETWORK, OR 1 OF THOSE
NETWORKS AS APPROPRIATE.
FOR THE OTHER PROGRAMS, IT'S
KIND OF A DIFFERENT STRUCTURE.
SO NOTHING REALLY PRECLUDES US
FROM ADAPTING OR ADDING NEW
PROGRAMS TO THOSE EXISTING
NETWORKS BUT I THINK IT WOULDN'T
BE QUITE AS EASY AS JUST KIND OF
LAUNCHING 1 ADDITIONAL TRIAL.
AND SO, WHAT I THINK A LOT OF
THE GROUPS LEADING THOSE
PROGRAMS, ARE THINKING AS WELL,
THEY WERE LAUNCHED IN 2019, THEY
HAVE A COUPLE YEARS UNTIL A LOT
OF THE TRIALS THAT LAUNCHED AT
THAT TIME BEGIN TO SUN SET AND
PERHAPS WHEN THAT TIME COMES,
THERE WILL BE A MOMENT TO THINK,
WELL, WHAT HAVE WE LEARNED?
WHAT DO WE STILL NEED TO LEARN
AND TO WHAT DEGREE DOES A
CONTINUATION OF THIS PROGRAM OR,
YOU KNOW PERHAPS A MORE
STREAMLINED EXTENSION OF A
PROGRAM WOULD MAKE SENSE.
AND FOR EMPOWER, I WOULD BE
INTERESTED TO HEAR--FOR EMPOWER
SPECIFICALLY I WOULD BE
INTERESTED TO HEAR WHAT NORA AND
WALTER WOULD SAY ABOUT HOW
THEY'RE THINKING ABOUT THE
FUTURE OF THAT PROGRAM BUT THEN
ALL THE MEMBERS OF THE EXECUTIVE
COMMITTEE FEEL FREE TO JUMP IN
BECAUSE YOU HAVE PROGRAMS IN
YOUR ICs THAT ARE RELEVANT AS
WELL.
>> YEAH, THIS IS WALTER, I THINK
IT'S JUST KIND OF KICKING OFF
NOW AND LAUNCHING.
CERTAINLY, IF WE FIND THAT YOU
KNOW IT'S A SUCCESSFUL PROGRAM,
THEN I THINK WOO CAN CERTAINLY
ADD ON TO IT, OVERTIME.
I SUSPECT, YOU KNOW IT'S A BIG
PROBLEM.
IT'S NOT GOING TO BE SOLVED
ACROSS THE COUNTRY IN A SHORT
TIME FRAME.
SO THE GOAL IS GOING TO BE A
LONG-TERM GOAL, WE WILL CONTINUE
TO WORK ON AND HOPEFULLY THE
EMPOWER GROUP AS THEY START
WORKING WILL BE A FORCE THAT WE
CAN CONTINUOUSLY INVEST IN TO
GET THE WORK DONE, NOW NORIA DO
HAVE YOU ANYTHING TO ADD?
>> NO, I THINK THAT YOU
BASICALLY, THE PLAN THAT IS A
STEP PLAN AND WE WILL LEARN
BASED ON THE RESULTS FOR US HAS
BEEN IN THE CLINICAL TRIAL
NETWORK, IT HAS BEEN WORKED FOR
MANY, MANY YEARS AND ENABLED US
TO WORK FAIRLY RAPIDLY BUT OF
COURSE WE'RE CONSTRAINED BY NOW,
THE RECRUITMENT OF PATIENTS, BUT
WE ALSO WANT THE CLINICAL TRIAL
NETWORK THAT HAS THE DIVERSITY
AND FLEXIBILITY TO CHANGE AND
ACCOMMODATE AND IN THAT CONTEXT
WE'RE VERY, VERY EXCITED AND
SEEING OPPORTUNITIES WHERE WE
CAN BRING APPROXIMATE SOME OF
THE CLINICAL TRIALS THAT ARE
BEING DONE ON PAIN TO PATIENTS
WITH SUBSTANCE USE DISORDERS
BECAUSE THE CO MORBIDITY IS SO
HIGH.
SO INDEED, I THINK THAT THE
BUILDING UP OF THE EMPOWER WILL
ALLOW US TO DO THINGS THAT
OTHERWISE WOULD NOT BE POSSIBLE.
UPON --SO, THANKS.
DR. VOLKOW, I BELIEVE YOU ARE
FIRST UP.
>> YES, IT'S SURPRISED ME
BECAUSE I THINK IT WAS STILL
2:00 BUT I MAY HAVE LOOKED
AGAIN.
AS ALWAYS IT'S A PRIVILEGE TO BE
HERE WHERE WE ARE AND GIVE YOU
AN UPDATE AND THE ISSUES OF THE
OVERDOSE CRISES THAT WE'RE
LIVING THAT WAS ALSO TALKED
ABOUT IN THE INTRODUCTION, AS
DR. TABAK, AND THESE HAVE GOTTEN
WORSE AND WE SEE THIS IN THE
NUMBERS.
SO I WILL SHARE THE SCREEN TO
IDENTIFY TOUGH ISSUES I WANT YOU
TO BE AWARE BECAUSE OF COURSE,
THEY COULD BENEFIT FROM FURTHER
RESEARCH.
LET ME GET WHICH 1 OF THESE IS
IT AND I NEED TO KNOW SOMEONE TO
TELL ME, IF YOU CAN SEE MY
PRESENTATION FOR 1 SECOND----SO
THIS IS THE DAT ATHE LATEST DATA
THAT WE HAVE WHICH IS FROM 2021,
THE 12 MONTHS THAT END ON
SEPTEMBER 30, 2021 AND YOU CAN
SEE IN THAT AREA THERE WAS 68%
OF INCREASES.
IN LOOKING AT THE DATA, I MEAN
THERE ARE--THERE IS INFORMATION
THAT IS VERY VALUABLE FOR US TO
QUANDER UPON BECAUSE IT'S
TELLING US SORT OF A CERTAIN
PERSPECTIVE OF WHAT'S HAPPENING
OR WHAT IS HAPPENING IN THE PAST
FIRST OF ALL HEROIN IS GOING
DOWN WHICH IS AGAIN, SOMETHING
WE HAVE STARTED TO SEE IN THE
PAST 5 YEARS, WITH HEROIN AND
FENTANYL, THIS IS GOING DOWN.
VERY IMPORTANTLY THIS COLUMN
HERE OF NATURAL AND
SEMISYNTHETIC WHICH REFLECTS
PRESCRIPTION ON OPIOIDS,
BASICALLY VERY STABLE AND THAT
REFLECTS WHAT ALSO WE HAVE BEEN
SEEING THAT THE RELATIVE
CONTRIBUTION OF OVERDOSES FROM
PRESCRIPTION OPIOIDS HAS COME
DOWN FROM BEING 1 OF THE MAIN
CONTRIBUTIONS FOR OVERDOSE
DEATHS, EARLY IN THE EPIDEMIC TO
NOW BEING BASICALLY 1 OF THE
COMPONENTS AND NOT THE MOST
IMPORTANT 1.
I ALSO WANT YOU TO LOOK AT
METHADONE BECAUSE WITH THE
CHANGES IN METHADONE PRACTICES,
1 OF THE CONCERNS WAS THAT AS
PEOPLE ARE ALLOWED TO TAKE HOME
METHADONE, MUCH MORE FREELY FROM
THE METHADONE CLINICS THERE WAS
CONCERN THAT THIS WOULD BE
OPIOID DIVERSION AND THEN
OVERDOSES.
WE NOW HAVE DATA TO SHOW AS THE
EVIDENCE FROM HERE, THAT THIS IS
NOT THE CASE.
WE HAVE NOT SEEN AN INCREASE IN
OVERDOSE DEATHS WITH METHADONE
WHICH WOULD HAVE BASICALLY
INDICATED THAT THE PRACTICES
HAVE EXACERBATED THE PROBLEM, IT
DOES NOT APPEAR TO BE THE CASE.
ON THE 1 HAND WE ARE SEEING THAT
MANY PATIENTS HAVE BENEFITED
FROM THIS FLEXIBILITIES.
ON THE OTHER HAND, YOU WILL SEE
WHAT WE HAVE BEEN COMMENTING
UPON THAT IS DRIVING THE
OVERDOSE DEATHS, FENTANYL, 26%
OF THAT INCREASE IN FENTANYL
OVERDOSE DEATHS AT LEVELS THAT
WERE ALREADY VERY, VERY HIGH.
AND THE OTHER EXTREMELY
IMPORTANT CULPRIT THAT WE HAD
BASICALLY JUST GONE UP AS
STEEPLY AS FENTANYL IS
METHAMPHETAMINE.
AND THAT IS INCREASINGLY
ACCOUNTING FOR OVERDOSE
MORTALITY AND WHAT IS RELEVANT
THAT THE PARTICULARS OF THE DRUG
AFFECT GROUPS DIFFERENTLY AND WE
NEED TO GET THAT DATA, MUCH MORE
ACCURATELY.
SO, LAST TIME WE LOOKED, I SAID
WE NEED DATA THAT IS MORE
TIMELY, THIS IS 6 MOCKS OLD, BUT
WE ALSO NEED TO UNDERSTAND THE
SPECIFICS OF THIS DATA SETS.
SO, WHAT DO I MEAN BY THIS?
FIRST OF ALL WE KNOW THAT THE
EPIDEMIC HAS BEEN CHANGING QUITE
DRAMATIC LOAMACYY IN TERMS OF
GEOGRAPHIC PRESENTATION, IN
TERMS OF ETHNICITY, RACIAL
GROUPS URBANNIVERSEUS RURAL AND
WHAT YOU SEE HERE IS YES,
PREDOMINANCE INITIALLY OF SORT
OF IN THE WHITES, THE WHITES
WERE THE 1S BASICALLY MOSTLY
AFFECTED OTHER THAN AMERICAN
INDIANS THAT HAVE HAD AN
OVERREPRESENTATION OF OVERDOSE
DEATHS.
THIS DOES NOT NECESSARILY
CAPTURE BUT THE NUMBERS HERE ARE
SISMGLE, CLEAR AND POINT TO
ACTUALLY SOME OF THESE ISSUES.
THIS REPRESENTS THE RATES OF
POPULATION DEATHS.
LOOK AT THE AMERICAN IBDIAN
NUMBERS AND CAN YOU SEE HOW THE
BLACK, FROM OVERDOSES ACTUALLY
HAVE BEEN GOING UP
SIGNIFICANTLY.
SO NOW WE HAVE UNACCEPTABLE
NUMBERS AS IT RELATES TO DEATHS
FROM AMERICAN INDIAN, ALASKA
NATIVE, IT'S 41.9 PER HUNDRED
THOUSAND.
I MEAN THIS IS A HUGE NUMBER.
SIMILARLY FOR BLACK IS 35.4 EVEN
THOUGH THOSE NUMBERS WERE
RELATIVELY LOW AT THE EMERGENCE
OF THE EPIDEMIC, WHICH IS REALLY
INDICATING THERE IS A CHANGE IN
THE WAY THAT THE OVERDOSE THAT'S
HAPPENING.
I ALSO WANT YOU TO--I WILL ALSO
FOCUS ON ANOTHER POPULATION
BECAUSE IT'S SOMETHING THAT WE
HAVE NOT PAID ATTENTION
INITIALLY SINCE IT WAS NOT A
POPULATION THAT WAS AFFECTED.
THIS WAS ASIANS AND HISPANICS.
SO STILL, THE HIGHEST MORTALITY
OF OTHERS IN INDIVIDUALS THAT
ARE 24-54 YEARS OF AGE,
INTERESTINGLY THE MORTALITY FROM
OVERDOSES IN OUR LESSONS WAS
CERTAINLY INITIALLY WAS VERY,
VERY LOW AND AS A RESULT OF THAT
WE HAVE NOT BEEN TRACKING IT,
AND PARTICULARLY BECAUSE IN OUR
LESSONS WE HAVE SEEN SOME OF THE
LOWEST LEVELS EVER OF
COMSUMPTION OF HEROIN AND WE
HAVE SEEN A VERY DRAMATIC
REDUCTION IN THE ORGANIZATION
AND THAT MEANS USE OF
PRESCRIPTION OPIOIDS.
BUT LOOK AT THIS DATA THAT SHOWS
OVERALL DRUG OVERDOSES AND THEN
IDENTIFIED WITHIN THOSE DRUG OR
OTHER DRUG OVERDOSES, THE 1S
THAT ARE AREYALATED TO FENTANYL
FROM 2015-2020.
AND YOU CAN SEE WHY THIS IS A
MAJOR AREA OF CONCERN.
ALL OF US ARE IN IT, WE'VE SEEN
CLOSE TO A 5-FOLD INCREASE IN
DEATHS IN TEENAGERS, THIS IS
12-20 YEARS OF AGE, IN 5 YEARS
AND IT IS DRIVEN BY FENTANYL.
AND THIS IS NOT EXPLAINED BY THE
RATE OF DRUG USE WHICH WE
MONITOR THROUGH MONITORING IN
THE FUTURE WHICH HAS BEEN
ACTUALLY QUITE STABLE ACROSS ALL
OF THESE YEARS AND ACTUALLY IF
ANYTHING, HAS SIGNIFICANTLY
REDUCED AMONG TEENAGERS DURING
THE COVID PANDEMIC SO THE
QUESTION IS WHAT'S DRIVING THESE
OVERDOSES.
SO IF THEY ARE NOT TAKING HEROIN
AND THEY ARE NOT TAKING
FENTANYL, BY THE EXAMPLE, THE
RATE OF--HEROIN USE IN 12 GRADE
WHICH HAS THE HIGHEST RATE, IS
MORE THAN 5 PERCENT, IT'S VERY
LOW AND I AM SHOWING YOU THE
NUMBERS FOR 12 GRADER WHICH IS
HAVE THE HIGHEST RATE OF USE,
FOR 2021 THAT INDICATES IN
GRANTS WHAT ARE THE DRUGS THAT
ARE FAVORED BY TEENAGERS AND WE
NEED TO UNDERSTAND THESE BECAUSE
IF WE WANT TO PREVENT THE
OVERDOSES, WE HAVE TO UNDERSTAND
WHAT'S DRIVING IT.
IT'S INTERESTING AND I'M MARKING
IT IN DIFFERENT COLORS AND WE'VE
KNOWN ALL ALONG THAT TEENAGERS
DO FAVOR PRESCRIPTION PILLS,
THESE CAN BE TRAINK QUILLIZERS
LIKE BENZOs, AMPHETAMINES AND
THEY ALSO FAVOR OPIOIDS, COUGH
MEDICINE, OTHER THAN HEROIN, OR
VICODIN ISSUE BUT THESE AS I
MENTIONED THESE HAVE BEEN GOING
DOWN.
RIGHT NOW IT'S .9%, BUT IT'S
STILL GOING DOWN, THERE ARE
STILL 1 OF THE FAVORITE DRUGS OF
ABUSE.
NOW IN IS RELEVANT BECAUSE IN
THE MEAN TIME WHAT WE HAVE SEEN
IS A SIGNIFICANT INCREASE IN THE
NUMBER OF COUNTERFEIT PILLS THAT
ARE ACTUALLY BEING FOUND TO
CONTAIN FENTANYL.
AND I WAS TESTIFYING IN CONGRESS
WITH DEA AND THIS WAS SOMETHING
THAT ACTUALLY CAPTURE THE
MOMENT, DEA AND LAW ENFORCEMENT
PARTNERS HAVE SEIZED MORE THAN
50 MILLION FAKE PILLS, THIS IS
DECEMBER 2021, AND AMOUNT THAT
HAS CONTINUED TO RISE
DRAMATICALLY.
30 MILLION OF THESE FAKE PILLS,
AT LEAST 2/3RDS OF THEM WERE
LACED WITH FENTANYL, 4 IN 10
CONTAIN A LEATHAL FENTANYL DOSE.
SO 1 THING THAT MAY BE COUNTING
FOR THE OVERDOSE, MORTALITY
COULD BE COUNTERFEIT PILLS THAT
ARE 1 OF THE THINGS THAT ARE
BASICALLY RAISED THAT DRAWS
FAVOR BY TEENAGERS.
THEY ARE NOT PERCEPTIVE TO THEM,
THEY ARE MISUSING THEM AND 1
SINGLE EXPOSURE CAN RESULT IN IT
DEATH.
BUT OTHER ISSUES THAT WE NEED TO
PAY ATTENTION TO IS THAT WE ARE
FOCUSING ON FENTANYL BUT THERE
HAS BEEN AN INCREASE IN REPORTS
OF OTHER SYNTHETIC OPIOIDS THAT
ARE ALSO EXTREMELY POTENT AS
POTENT OR MORE THAN FENTANYL.
PARTICULARLY NOTABLE IS
[INDISCERNIBLE] THAT WAS
REPORTED FOR THE FIRST TIME IN
CANADA IN 1919 AND ACCOUNTED FOR
MORE THAN 200 OVERDOSE DEATHS
AND AUGUST 2020 BECAUSE OF THE
NUMBERS IT WAS STILL A SCHEDULE
1.
IT IS LISTED AS AN ANNUAL
EMERGING
EMERGING THREAT REPORTS AND
THERE ARE OTHER NITAZINES THAT
ARE USED IN THE MARKET, IT'S
PROBLEMATIC BECAUSE IT IS NOT
DETECTED BY MOST TESTS.
AND ACTUALLY IS NOT NECESSARILY
EVALUATED IN POSTMORTEM DEATHS.
SO THIS IS BRINGING IT FORWARD
BECAUSE IT IDENTIFIES THE NEED
TO HAVE WAYS OF MEASURING THE
EMERGENCE OF A THERAPY ENTHETIC
OPIOIDS THAT ARE GOING TO BE
PROLIFERATING AND WITHOUT THE
PROPER KNOWLEDGE, MAY RESULT IN
THE TREATMENT.
SO AS A RESULT OF THESE, AND
BASED ON THE DATA I AM SHOWING,
SORT OF LOOKING AT WHERE WE ARE,
I WANT TO IDENTIFY 4 KEY GAP
AREAAS THAT WE NEED TO ADDRESS
TO KEEP OVERICOSES,--TO PREVENT
OVERDOSES.
APART FROM THE 1S THAT ARE
ALREADY BEING LOOKED AFTER, WE
NEED MORE TIMELY DATA.
THERE'S NO 2 WAYS AROUND IT.
RESPONDING 6 MONTHS LATER
BASICALLY MEANS THAT A LOT OF
PEOPLE HAVE DIED IN THE MEAN
TIME.
WE NEED EXPANDED DRUG TESTING
CAPABILITIES.
AND THIS SHOULD INCLUDE
MONITORING FOR THE USE OF DRUGS,
OTHERWISE, THEY WILL NOT BE IN
THE RADAR OF DRUGS THAT ARE IT
ACTUALLY ACCOUNTABLE FOR THOSE
OF INDIVIDUALS AND A TARGET THAT
INTERVENTIONS MAY NOT BE AS
EFFECTIVE.
IN THE AREA OF PREVENTION, WE
DEFINITELY NEED TO EXPAND
PREVENTION EFFORTS TO ADDRESS
RISKS FROM EXPOSURE FROM
FENTANYL CONTAMINATED DRUGS AND
THAT COULD INCLUDE
BENZODIAZPINES AND STIMULATION
MEDICATIONS THAT ARE BASICALLY
ILLICITLY MANUFACTURED.
AND THIS INCLUDES ADOLESCENTS
AND INDIVIDUALS IN THE
PRE-ADDICTION STAGE.
AS WE ADDRESS ADDICTION, WE NEED
TO ACTUALLY UNDERSTAND THAT WE
HAVE TO, APPLY MODELS THAT ARE
SIMILAR TO THOSE THAT ARE
PREDIABETES IN ORDER TO TREAT
ESCALATION.
AND FOR TREATMENT, WE NEED TO
IMPROVE ACCESS, QUALITY AND
RETENTION.
AND WITH THAT I WANT TO THANK
YOU FOR ALL OF YOUR EFFORTS AND
I TURN TURNOVER MICROPHONE TO WALTER.
>> THANK YOU VERY MUCH, NORA.
>> I WILL STOP SHARING.
>> WALTER, WE HAVE YOUR SLIDES,
SO YOU DON'T NEED TO SHARE IF
YOU DON'T WANT TO.
>> YOU HAVE MY SLIDES?
>> SO I WILL TALK ABOUT THE PAIN
PICTURE FROM THE BIG VIEW AND
JUST TO START OUT BY SAYING THAT
OPPOSE TO THE SUBSTANCE ABUSE
PROBLEM, WE DON'T HAVE AN
INSTITUTE THAT'S DEVOTED TO PAIN
BUT WE BASICALLY HAVE LIKE A
NATO EQUIVALENT WHICH IS A WHOLE
BUNCH OF INSTITUTES THAT HAVE
GOTTEN TOGETHER AND THE HEAL
INITIATIVE HAS REALLY MADE SUCH
A DIFFERENCE IN BRINGING US
TOGETHER TO DO SOME REALLY
AMBITIOUS PROJECTS THAT WE COULD
NEVER HAVE DONE ON OUR OWN AND
SO HATS OFF TO NCATS AND JOHNNY
[INDISCERNIBLE], AND NIAMS, AND
LINDSAY CRISWELL, AND LYNN
LANGEVIN, AND NIDCR, RENA
DESOUZA, AND WORKING WITH NINDS
CONSISTENTLY ON THE PAIN SIDE OF
HEAL.
AND SO, YOU KNOW WHAT--WHY
INSTITUTES HAVE ALL FUNDING AND
HELPED WITH OUR OANS INSTITUTES
BUT HEAL ALLOWED US TO DO THINGS
THAT CUT ACROSS ALL INSTITUTES
AND NOT THINGS WE COULD HAVE
DONE PREVIOUSLY ON OUR OWN.
I SAY, I THINK OF THE GOAL OF
HEAL AS 3 FOLD.
AND AS YOU CAN SEE HERE ON THE
RIGHT, WHEN WE STARTED OFF WITH
HEAL, PRESCRIPTION OPIOIDS WERE
THE LEADING CAUSE OF OPIOID
DEATHS THAT WAS SURPASSED VERY
UNFORTUNATELY BY THE SYNTHETIC
OPIOIDS BUT PRIMARILY FENTANYL
AS NORA WAS TELLING AND THERE
HAS BEEN SOMEWHAT OF A DROP IN
THE DEATHS DUE TO PRESCRIPTION
OPIOIDS BI IT'S STILL BASICALLY
THE WILL SAME AS HEROIN AND THE
OTHER CONTRIBUTORS HERE.
SO IT'S STILL A SUBSTANTIAL
PROBLEM IN THE U.S. AND IT IS
WHAT FUELED THE PROGRAM TO BEGIN
WITH AND SO HOW DO WE--HOW DO WE
SOLVE THIS KIND OF DUAL PROBLEM,
OPIOID TESTS AND THEN THE REALLY
POOR TREATMENT OF PAIN, AND THE
NATIONAL HEALTH STATISTICS ARE
THAT 1 IN 20 PEOPLE IN THE
ADULTS IN THE U.S. REPORT THAT
THEY HAVE PAIN ALMOST EITHER
EVERYDAY OR ALMOST EVERY DAY AND
A GOOD PROPORTION OF THEM, THE
PAIN ABOUT 40-50% OF THOSE
PEOPLE, THE PAIN IS IMPAIRING
THEIR FUNCTION.
SO PAIN IS WITH US.
IT'S BEEN WITH US THROUGHOUT OUR
HISTORY AND OPIOIDS
UNFORTUNATELY HAVE BEEN WITH US
THROUGHOUT OUR HISTORY AND
ALTHOUGH THEY CAN BE QUITE
EFFECTIVE AND ACUTE PAIN,
THEY'RE NOT VERY EFFECTIVE IN
CHRONIC PAIN AND THEY RUN THIS
BIG RISK OF HOOKING PEOPLE TO
THE POINT WHERE THEY BECOME
ADDICTED AND POTENTIALLY DIE
FROM THEIR ADDICTION.
SO, THE L IN HEAL IS
REALLY--STANDS FOR LONG-TERM AND
I THINK IF WE'RE GOING TO SOLVE
THIS PROBLEM, LONG-TERM, WE
REALLY NEED BETTER NONADDICTIVE
DRUGS TO MANAGE PAIN.
AND THAT'S A MAJOR FOCUS OF THE
HEAL INITIATIVE AND IT'S TO
STIMULATE THE COMMERCIALIZATION
OF PRODUCTS THAT COME OUT OF THE
SCIENCE THAT WE ARE ALL DOING
HERE AT NIH, IN THE PAIN SPACE.
SO ALTHOUGH LARGE PHARMA IS
MOSTLY ABANDONED THE DEVELOPMENT
OF NEW THERAPIES, THERE ARE
BIOTECH COMPANIES WE CAN WORK
WITH AND HOPEFULLY THOSE WILL BE
MOVED INTO BIG PHARMA AT SOME
POINT.
PAIN SCIENCES HAVE DEFINITELY
MADE STUDY ADVANCES PRODUCING A
PLETHORA OF TARGETS FOR NEW
NONADDICTIVE THERAPIES.
SO A BIG PORTION OF THE HEAL
INITIATIVE IS IT DEVELOPED NEW
THERAPIES THAT COULD HELP THE
TREATMENT OF CONDITIONS THAT CUT
ACROSS MANY OF OUR INSTITUTES.
AND IN THE SHORT-TERM, I THINK
WE CAN ALSO HELP BY COLLECTING
THE KIND OF EVIDENCE THAT WILL
PROVIDE PATIENTS AND PHYSICIANS
ON WHAT IS THE BEST WAY TO
MANAGE THEIR DIFFERENT PAIN
CONDITIONS AND THE BEST WAY
BEING DEFINED AS THOSE THAT GET
THEM TO THE HIGHEST FUNCTIONAL
LEVEL AND CERTAINLY OPIOID
OVERUSE WILL BE A NEGATIVE DRAW
ON THAT, SO AGAIN, THE
APPROPRIATE USE OF OPIOIDS IS
IMPORTANT TO UNDERSTAND BUT ALSO
WHAT ARE THE OPTIONS AND WHAT
ARE THE RISKS AND THEN,
PARTICULARLY IN THE CHRONIC PAIN
SPACE, WHERE, YOU HAVE VERY
LITTLE IN THE WAY OF EFFECTIVE
TREATMENTS.
WE REALLY NEED TO PUSH ON THAT
FROM THE SCIENCE STANDPOINT.
NEXT SLIDE.
ON THE NEXT SLIDE, YOU SEE KIND
OF ACROSS THE BOARD HOW HEAL
STANDS UP IN THESE DIFFERENT
AREAS SO THE BOTTOM OF THE SLIDE
IS NOT SHOWING.
>> THERE IT IS.
SO MOST OF THE DISCOVERY WORK IS
ACTUALLY DONE IN THE INSTITUTES
BUT WE HAVE A PROGRAM IN
CHRONIC, THE COMMON FUND
PROGRAM, TO LOOK AT THE RICK
FACTORS THERE AND DISCUSS THE
PROGRAMS GOING ON THERE.
WE HAVE 2 PROJECTS GOING ON IN
THE POST SURGICAL CHRONIC PAIN.
WE HAVE SOME REALLY NOVEL
PROGRAM TO DISCOVER
FUNCTION--DISCOVER NEW TARGETS
FROM THE FUNCTION WILL
EVALUATION OF THE HUMAN PAIN
GENES IN CELLS AND THIS IS
TISSUES THAT HAVE TAKEN AND
TISSUES THAT CAN ACTUALLY BE
INVESTIGATED AND YOU CAN
ACTUALLY RECORD FROM THE ROOT
GANGLION CELLS AND ISSUES TAKEN
FROM HUMAN AT THE TIME OF
SURGERY AND I WILL MENTION SOME
OF THESE KIND OF INTERESTING
DISCOVERIES AS WE GO ALONG.
THE ISSUE IN TERMS OF MOVING
THINGS FROM DISCOVERY TO THERAPY
IS IN THIS VALIDATION SPACE.
SO, THERE ARE A PLETHORA OF
TARGETS ISSUES THE QUESTION IS
HOW MANY WERE REALLY GOOD
TARGETS AND THAT'S THE ISSUE OF
VALIDATION UNDERSTANDING THE
ROBUSTNESS OF THE EFFECT OF
TARGETING A PARTICULAR RECEPTOR,
SAY FOR INSTANCE, SO THAT'S THE
KIND OF WORK THAT IS NOT THE
SAME AND DISCOVERY STUFF THAT
NIH HAS BEEN REALLY STRONG IN
BUT IT'S THAT NEXT STEP TO
VALIDATE THESE TARGETS, IT'S A
LITTLE MORE WROTE BUT WITHOUT
THAT, THE PROGRESS TO GET
THERAPIES IS STYMIED.
WE HAVE ALSO A COUPLE OF
RESOURCES.
WE HAVE A PRECLINICAL SCREENING
PLATFORM, RUN BY PSYCHOGENICS
WITH MANY DIFFERENT AIM MODELS
THAT PEOPLE CAN BRING THEIR
ASSETS IN TO HAVE THEM TESTED
AND THIS IS EEP TO ACADEMICS OR
INDUSTRY FOLKS.
NCATS HAS A REALLY STRONG
PROGRAM IN PURSUING TARGETS AND
CELL-BASED ASSAYS WITH KIND OF
THE TECHNOLOGIES THAT ARE
AVAILABLE IN A LOT OF FORM
SUITICAL COMPANIES NOW THESE ARE
AVAILABLE TO OUR ACADEMIC
INVESTIGATORS AS WELL.
AND WE HAVE A NUMBER OF PROGRAMS
TO BRING NOVEL THERAPIES TO THE
POINT WHERE THEY CAN GET AN IND
FROM THE FDA AND POTENTIALLY GO
INTO PATIENTS AND HOPEFULLY IN
THAT PROCESS, THOSE THERAPIES
DERISK TO HELP THEM MOVE THEM
INTO THOSE NEW PHASE 3 TRIALS,
LOOKING AT DEVICE PAIN RELIEF
WORKS BUT IT'S NOT CLEAR HOW.
BUT THIS COULD BE SOMETHING THAT
COULD REALLY IMPROVE THE
DEVELOPMENT OF BETTER DEVICE,
STIMULATION OF AFFECTING
NEUROCIRCUITS TO REDUCE PAIN.
THE LACK OF BIOMARKERS HAS BEEN
A CRITICAL DEFICIT IN MOVING
THERAPIES FROM THE CLINICAL TO
THE PRECLINICAL SPACE.
COMPANIES HAVE FOUND THAT THE IN
THE ANIMAL MODELS ARE NOW
PREDICTING WHAT HAPPENS WHEN YOU
GO INTO THE CLINIC AND IT'S THIS
LACK OF BIOMARKERS OF TARGET
ENGAGEMENT AND PROOF OF
PRINCIPLE THAT WE'RE HOPING TO
BUILD IN THE HEAL PROGRAM AND
THESE COULD POTENTIALLY, YOU
KNOW IF THEY'RE--IF THEY'RE THEY
WORK THEY COULD CUT ACROSS A
WHOLE BUNCH OF PAIN CONDITIONS,
SO IF IT'S A BIOMARKER OF SAY
INFLAMMATORY PAIN, SO WE COULD
HAVE BREAK THROUGHS IN THE
BIOMARKERS SPACE THAT COULD
REALLY MOVE THE THERAPEUTIC
DEVELOPMENT FORWARD.
WE'RE MAKING BIG EFFORTS IN
MUSCULOSKELETAL PAIN TO DEVELOP
BI ON O MARKERS IN THE
BACK--BIOMARKERS IN THE BACK
PAIN CONSORTIUM, FOR THE
PHENOTYPE, UNDERSTAND THE
MECHANISMS BEHIND DIFFERENT
TYPES OF BACK PAIN, BACK PAIN
BEING THE LARNLEST CAUSE OF
DISABILITY IN THE UNITED STATES.
YOU ALSO HAVE NETWORK, PHASE 2
NETWORK TO TEST NEW THERAPIES
AND ACTUALLY HAVE 3 BIOTECH
COMPANIES, PRODUCTS NOW BEING
TESTED IN THE [INDISCERNIBLE] WE
HAVE THE EFFECTIVENESS NETWORK
FOR COMPARATIVE EFFECTIVENESS
RESEARCH TO GIVE INFORMATION
BACK TO PHYSICIANS AND PATIENTS
ON BEST TREATMENTS, HEMODIALYSIS
PAIN PROGRAM AND THE PRISON
PROGRAM KLF-TWO WAS MENTIONED
WHICH IS PRAGMATIC TRIALS,
PARTICULARLY IN THE HEALTHCARE
SYSTEM AND HEAVILY NOW ON THE
NONPHARMAICOLOGICAL TREATMENTS
OF PAIN.
SO THAT'S HOW IT LOOKS IN THE
BIG PICTURE.
NEXT SLIDE.
I JUST WANT TO SAY LOOKING
FORWARD, A COUPLE OF THINGS THAT
WE ARE LOOKING FORWARD TO WORK
ON, HEALTH EQUITY AND THAT'S
REALLY ESSENTIAL TO THE NEW
INITTIAIVE ITS WE'RE PUTTING
FORWARD.
HOW DO WE DO RESEARCH TO
IDENTIFY INIQUITIES AND HOW
PEOPLE ARE TREATED FOR THEIR
PAIN AND THEN WHAT CAN WE DO TO
ATTENUATE THOSE OR OBLIT RATE
THEM.
IN THE PAIN SPACE, THERE HASN'T
BEEN A TREMENDOUS EFFORT IN
DEVELOPING A WORKFORCE THAT'S
CLINICAL AND WORKFORCE WORKING
ON DEVELOPING NEW PAIN THERAPIES
OR TESTING NEW PAIN THERAPIES,
SO I'M TRYING TO GET
PARTICULARLY A CLINICAL
INVESTIGATORS INTO THIS AREA IS
CRITICALLY IMPORTANT FOR US AND
WE WILL BE SUCCESSFUL DOWN THE
LINE.
DATA INTEGRATION, YOU WILL HEAR
ABOUT LATER ON, AND THEN, ALSO
MENTIONED WITH EMPOWER WE'RE
GETTING INTO A VERY TOUGH
PROBLEM IS HOW DO YOU MANAGE
PAIN IN PEOPLE WHO ARE USING
OPIOIDS, SOMETHING THAT MANY
PHYSICIANS JUST WON'T EVEN TRY
TO DO AND YOU KNOW THAT REALLY
LEAVES PEOPLE WITHOUT OPTIONS,
EXCEPT FOR THEIR OPIOIDS WHEN
THEY HAVE PAIN AND THAT CAN
CERTAINLY HAVE A BAD OUTCOME.
AND WE VERY MUCH, AGAIN, WOULD
LIKE TO REDOUBLE OUR EFFORTS TO
DO RESEARCH THAT WILL INFORM THE
PRIMARY CARE PHYSICIANS AND
HEALTHCARE SYSTEMS WHERE
PATIENTS ARE GOING TO PRESENT
WITH THEIR PAIN AND TO DEVELOP
INTEGRATED SYSTEMS TO SUPPORT
THE PRIMARY CARE PHYSICIANS AND
THEIR CARE OF PATIENTS WITH
PAIN, THE SAME PEOPLE EVERY 15
MINUTES, THEY WILL REALLY NEED
SUPPORT FOR A COMPLICATED
PATIENT WITH CHRONIC PAIN AND
HOW TO BUILD THOSE SUPPORTS IN
IT, IS SOMETHING THAT WE'RE REAL
INTERESTED IN DOING.
NEXT SLIDE.
AND JUST WANTED TO MENTION A
COUPLE THINGS, IN TERMS OF THE
SCIENCE, THE SCIENCE OF PAIN,
IT'S ALWAYS BEEN, YOU KNOW
REALLY INTERESTING TO ME, AND
IT'S EXPANDED OVER THE YEARS,
AND JUST TO SAY THAT, YOU KNOW
THAT THE--NOBEL PRIZE WAS GIVEN
TO 2 PAIN SCIENTISTS FOR THE
DISCOVERY AND THE 3D STRUCTURE
OF PAIN, TEMPERATURE RECEPTORS
AND THIS IS JUST THE BEGINNING
SO THERE IS NOW 3D STRUCTURES
FOR MANY OF THE RECEPTORS THAT 1
COULD INSILIC O DEVELOP DRUGS
THAT ARE GOING TO BE MORE
SPECIFIC AND POTENT THAN THE 1S
WE HAVE NOW WORKING RIGHT ON THE
PAIN SYSTEM WHICH IS NOT
EXPECTED TO BE ADDICTIVE.
THEN ALSO THE WINNERS OF THE BIG
BRAIN PRIZE IN 2021 WERE A GROUP
THAT WORKED ON CGRP AS THE
DRIVER OF SOME PEOPLE'S MIGRAINE
WHICH HAS NOW LED TO A
COMMERCIALIZATION OF MULTIPLE
ANTIGPR PRODUCTS FOR MIGRATION,
SO IT'S AN EXAMPLE OF, I
REMEMBER BACK DR. MIKE AT
MOSKOWITZ, IT WAS A 30 YEAR
EFFORT BUT PERSISTENCE HELPS.
NEXT SLIDE.
AND THEN JUST TO SAY THAT IN
THIS SPACE OF TRYING TO, YOU
KNOW--TO MONITOR AND MODULATE
CIRCUITS AND PAIN IT CLEARLY A
PROTOTYPICAL CIRCUIT DISORDER IS
NOT A PATHOLOGY IN GENERAL, IT'S
AN ABNORMAL CIRCUIT THAT'S BEEN
SET UP BY A AN EXPERIENCE OR
STIMULUS AND THE BRAIN
INITIATIVE IS DEVELOPING NEW
TOOLS TO ALLOW US TO INVESTIGATE
CIRCUITS AND THEY'RE GENERIC AND
CAN BE I THINK POWERFULLY
EMPLOYED TO THE PAIN SIDE OF
THINGS.
SO NEXT SLIDE, THIS IS JUST AN
EXAMPLE IN NATURE, A LARGE
AMOUNT OF WORK WAS PUBLISHED IN
OCTOBER, LOOKING AT WHAT WE CALL
THE CELL CENSUS OF THE DIFFERENT
TYPES OF CELLS IN THE BRAIN.
THIS WAS ENABLED BY BY NEW
GENOMIC HIGH THROUGH PUT STUDIES
THAT YOU CAN LOOK AT THE
TRANSCRIPT OHM IN THE CELL
CYTOPLASM OR YOU CAN LOOK AT A
DNA METHYLATION IN THE NUCLEUS
AND YOU CAN THEN CLASSIFY CELLS,
YOU CAN IDENTIFY CELL SPECIFIC
ENHANCERS, THAT CAN THEN BE USED
TO DELIVER ARTIFICIAL GENES THAT
CAN THEN ACTIVATE OR DEACTIVATE
SPECIFICALLY THOSE CELL TYPES.
YOU COULD EVEN PATCH CLAMP THE
CELLS AND LOOK AT THEIR
ELECTROPHYSIOLOGICAL PROPERTIES
AND YOU COULD ALSO INJECT THE
TRACERS EITHER GENETICALLY OR
PHYSICALLY INTO THESE CELLS TO
LOOK AT THEIR CONNECTIONS.
NEXT SLIDE.
FOR THE FIRST EFFORT THAT WAS
DONE IN THE MOTOR CORTEX, AND
THEY LOOKED AT HUMAN, NONHUMAN
PRIMATE AND MOUSE AND THE--YOU
KNOW LOOKING ACROSS SPECIES,
WHAT YOU FIND--NEXT SLIDE--IS
THAT THE CELL TYPES ARE ACTUALLY
PRETTY WELL CONSERVED BUT THE
ACTUAL TRANSCRIPT OHM IN THOSE
DIFFERENT CELL TYPES DIFFER.
SO YOU HAVE THE SAME CELL TYPES
BUT THEY'RE USING DIFFERENT
LEVERS AND MACHINERY THAT MAKES
THE DIFFERENCE BETWEEN THE BIG
DIFFERENCE BETWEEN THE MOUSE,
THE NONHUMAN PRIMATE AND THEN
LESS OF A CHANGE BETWEEN THE
NONHUMAN PRIMATE AND HUMANS.
NEXT SLIDE.
AND THIS IS REALLY IMPORTANT IN
UNDERSTANDING, YOU KNOW HOW WE
MOVE IN PAIN BECAUSE THERE ARE
CERTAIN--CERTAIN CHARACTERISTICS
OF THE MOUSE CELLS THAT ARE NOT
IN THE HUMAN IS VICE VERSA, SO
AVENUES OF WHERE YOU--THERAPIES
LOOK GREAT IN THE MOUSE AND NOT
IN THE HUMAN POTENTIALLY COULD
HAVE EXPLANATIONS IN THESE
DIFFERENCES.
NEXT SLIDE.
THESE TECHNIQUES ARE ALREADY
BEING APPLIED TO PAIN.
AND SO THIS IS A RECENT PAPER
OUT OF TED PRICE'S LAB LOOKING
AT GANGLION CELLS AND LOOKING AT
TRANSCRIPT OMES AND IDENTIFYING
WHOLE CELL TYPES OF IN THE
DORSAL ROOT GANGLION AND LOOKING
AT DIFFERENCES BETWEEN THE HUMAN
AND MOUSE AND THEN DIFFERENCES
BETWEEN MALES MALES AND FEMALES,
ANOTHER FACT WE HAVE TO DEAL
WITH AND MALES AND FEMALES
RESPOND TO PAIN AND HAVE
DIFFERENT RESPONSE TO PAIN
THERAPIES.
AND THEY ALSO WITH THIS
TECHNIQUE WERE ABLE TO IDENTIFY
WHOLE SERIES, HUNDREDS ACTUALLY
OF WHAT'S CALLED THE
UNDERSTUDIED DRUGGABLE GENOME SO
POTENTIAL CELL SPECIFIC PROTEINS
THAT MIGHT BE TARGETS FOR PAIN
THERAPIES.
NEXT SLIDE.
SO THE QUESTION IS, WHAT COULD
THIS LOOK LIKE DOWN THE ROAD?
I THINK THE ABILITY TO LOOK AT
THESE SIGNALING PATHWAYS ISSUES
SUCH AS THE ANTIPD1 TREATMENT,
YOU KNOW LOOKING AT OPENING UP
THE INFLAMMATORY RESPONSE TO
TUMORS, TURNS OUT THAT THAT'S
ALSO ACTIVE IN RECEPTION OF
DORSAL GANGLION CELLS.
PEOPLE HAVE BEEN ABLE TO
IDENTIFY IN THE AMYGDALA REGIONS
OF THE BRAIN THAT ARE
RESPONSIBLE FOR THE
UNPLEASANTNESS OF PAIN, BRINGING
TO THE IDEA--BRINGS UP THE IDEA
THAT YOU MIGHT BE ABLE TO TURN
OFF THE CENTER AND YOU WOULD
STILL BE ABLE TO DETECT A
PAINFUL STIMULUS, SO HOT COVERY,
YOU WOULD NOT SIP THE HOT COFFEE
BECAUSE YOU KNOW IT'S HOT BUT
YOU WOULDN'T HAVE THAT
UNPLEASANTNESS THAT IS
RESPONSIBLE FOR THE SUFFERING
DUE TO PAIN.
REALLY POWERFUL IDEA THERE.
BUT THERE IS CLEARLY CIRCUITS
THAT CONNECT THE NOSE-SUSCEPT
EPTOR WITH THE NEGATIVE VALENCE
OF PAIN THAT WE MIGHT BE ABLE TO
MANIPULATE WITH CHEMICALS,
DREADS, THE DREAD TECHNOLOGIES
ALLOW YOU TO POTENTIALLY TURN ON
OR TURN OFF PARTICULAR CELL
TYPES BASED ON THEIR
CELL-SPECIFIC ENHANCERS.
AND THERE'S OORLGT EXAMPLE
LOOKING AT THE DORSAL ROOT
GANGLION I MENTIONED EARLIER
TAKEN FROM HUMANS AND THEY ARE
ELECTRICALLY ACTIVE AND YOU CAN
STUDY THEM AND YOU WHAT WE FOUND
WAS IF YOU LOOK AT THE DORSAL
ROOT GANGLION CELLS FROM A
NORMAL SIDE DERMA TELOMERE WITH
NO PAIN, THE CELLS ARE
COMPLETELY I SILENT BUT LOOKING
AT THE SIDE WHERE THERE IS PAIN
DUE TO THAT ON THE CELLS ARE
FIRING ALL THE TIME.
SO THEY HAVE ACTUAL, THIS IS
PROJECTION
SPONTANEOUS ACTIVITY, YOU HAVE
PAIN ON THAT SIDE, YOUR
SPONTANEOUS ACTIVITY IS WAY UP,
AND SIMILARLY IF YOU HAD
COMPRESSION OF THAT NERVE ROOT,
THAT'S THE USUAL COURSE OF MAIN,
YOUR PROJECTION NEURONS OR PIONS
TIANYLIOUS ACTIVITY IS WAY UP.
SO, IT MAY BE SIMPLISTIC TO
THINK THAT SOMETHING THAT
DEPRESSES THE SPONTANEOUS
ACTIVITY IN THE DRG CELLS MIGHT
RELIEVE PAIN IN PEOPLE WITH ROOT
COMPRESSION.
SO AS I MENTIONED LOTS OF
TARGETS TO PURSUE AND THE HEAL
INITIATIVE ALLOWS US TO KIND OF
MOVE ALL THESE THINGS FORWARD TO
THE POINT WHERE PHARMACEUTICAL
COMPANIES, BIOTECHS CAN SEE THE
LOW RISK IN MOVING THEM FORWARD
IN THE POTENTIAL HIGH GAIN OF
MOVING THESE ADVANCES FORWARD
AND THAT'S WHAT I HOPE THE HEAL
INITIATIVE CAN BE SUCCESSFUL AT
WITHIN THE NEXT COUPLE OF YEARS.
SO I THINK THAT WAS MY LAST
SLIDE, I WANT TO THANK YOU FOR
ATTENTION AND I'M HAPPY TO
ANSWER ANY QUESTIONS OR TAKE ANY
ADVICE.
>> YEAH, WE CAN NOW OPEN IT UP
TO QUESTIONS FROM ANY ASPECTS OF
THE PRESENTATIONS YOU HEARD SO
FAR.
THANK YOU WALTER, THANK YOU
NORA.
>> HEY WALTER THIS IS WALLY
SMITH.
FASCINATING COUPLE OF SLIDES
THERE.
AND AS CLINICIANS WE
ANECDOTEALLY SEE SOME OF THESE
EXPRESSIONS AND DON'T KNOW WHAT
TO DO WITH THEM AND I WONDERED
IF YOU SAW ROOM FOR TEAMS OF
BASIC SCIENTISTS AND CLINICIANS
TO TEAM UP AND HOW THEY MIGHT
TEAM UP TO TRY TO BRING THE
CLINICAL COROLATES OF SOME OF
THOSE ELECTRICAL RESPONSES THAT
YOU JUST NOTED BETWEEN FOR
EXAMPLE, THE AMYGDALA AND THE
NOSE RECEPTORS?
>> REALLY GOOD QUESTION, BECAUSE
I THINK--IS THAT A CONCEPT WE'RE
PRESENTING TOMORROW?
I THINK IT IS.
BUT YOU'RE RIGHT, WE HAVE A LOT
OF THINGS GOING ON, BUT YOU'RE
RIGHT, WE'RE THINKING THAT WE
NEED TO BUILD THIS CLINICAL
WORKFORCE AND IT'S GOT TO BE
INTEGRATED WITH THE BASIC
SCIENCE AND THE BASIC SCIENCE IS
ACTUALLY QUITE STRONG.
IT'S--I MEAN, I'VE BEEN
IMPRESSED, I'M SURE A L HAS SEEN
JUST TREMENDOUS CHANGES OVER HIS
CAREER.
SO OUR PROPOSAL IS TO BUILD
THESE CENTERS THAT ARE GOING TO
FUSE THE CLINICAL AND THE BASIC
RESEARCHERS TOGETHER AND THEN
BUILD THAT WORKFORCE WHICH I
THINK IS--THAT'S THE SECRET FOR
SUCCESS IS TO BUILD THAT
INTEGRATIVE WORKFORCE BETWEEN
THE CLINICAL AND THE BASIC
SCIENTIST.
THAT'S 1 OF THE INITIATIVES WE
HAVE PLANNED.
I'M TRYING TO GET NORA TO THINK
ABOUT STIMULATION, TOO, BRAIN
STIMULATION AS A TREATMENT FOR
ADDICTION.
>> YEAH, THERE ARE SEVERAL
TRIALS GOING ON AND
METHODOLOGIES FROM ACTUALLY
NONINVASIVE WITH EMS OR DIRECT
CURRENT STIMULATION OR EVEN
PERIPHERAL NERVE STIMULATION TO
INVASIVE 1S WHERE YOU PUT THE
ELECTRODES, AND MOST OF THE WORK
ACTUALLY HAS BEEN WITH THE
ELECTRODES THAT ARE PLACED IN
THE NUCLEUS CIRCUMFERENCE AND
THE TRIALS IN THE UNITED STATES
HAVE BEEN RELATIVELY SMALL BUT
LOOK ACTUALLY QUITE INTERESTING.
WRASSE'REWHEREAS THERE'S ALSO
BEEN WORK IN OTHER COUNTRIES SO
THIS IS AN AREA OF VERY, VERY
ACTIVE RESEARCH.
>> BECAUSE ADDICTION IS ANOTHER
CIRCUIT DISORDER.
>> OF COURSE AND I THINK THAT
BASICALLY YOU'RE GOING TO FIND
THAT THEY ARE STRIPPED BECAUSE
THE BRAIN IS SUCH A COMPLEX
CIRCUIT OF CIRCUITS THAT THE
ISSUE IS IDENTIFYING HUBS THAT
BY MANIPULATING CAN HAVE A DOWN
STREAM EFFECT AND OBVIOUSLY IN
THE PAIN FIELD AS YOU HAVE BEEN
SHOWING, THE AMYGDALA IS
FUNDAMENTAL ACTUALLY IN
DETERMINING THE SEVERITY AND
PHYSICAL ABILITY TO ADAPT TO IT.
INTERESTINGLY ARE, THE AMYGDALA
ALSO NEGATIVELY INFLUENCES
OUTCOMES IN ADDICTION AND ENSTED
IN SUCH OTHER WAYS THERE IS A CO
MORBIDITY BETWEEN ADDICTION AND
PAIN AND A NEUROCIRCUITRY THAT
CAN BE ENGAGE INDEED BOTH OF
THESE CONDITIONS BECAUSE MOST
PEOPLE THAT ARE ADDICTED AND
TAKE DRUGS ARE NOT TAKING THEM
BECAUSE THEY HAVE THE CHOICE
THEY FEEL PRESSURE.
THEY TAKE IT BECAUSE THEY'RE
TRYING TO ESCAPE A --ACHIEVE A
VERY EUPHORIC STATE.
>> THIS IS ERIC GARLAND AND THIS
LAST SERIES OF COMMENTS MADE ME
WANT TO CHANGE MY COMMENT ABOUT
THE POINT YOU RAISED WALTER
ABOUT THE FACT THAT WE KNOW THAT
OPIOIDS DO NOT SEEM TO BE
PARTICULARLY EFFECTIVE FOR
CHRONIC PAIN AND YET THIS IS A
HIGHLY POLITICIZED AND DIVISIVE
ISSUE AND THERE ARE MANY
PATIENTS WHO THINK THEY NEED
THESE MEDICINES TO ALLEVIATE
THEIR PAIN AND WE KNOW THAT IN
THEIR CONSTRICTION OF THE OPIOID
PRESCRIBING IN THE WAKE OF THE
CRISIS THERE WAS AN INCREASE IN
SUICIDE AMONG THESE PATIENTS.
BUT I WONDER ABOUT YOUR THOUGHTS
HERE, WHAT DO WE DO ABOUT THIS
DISCONNECT BETWEEN THE EFFICACY
DATA AND THEN THE POLITICAL AND
SOCIAL CONCERN OF PATIENT WHO IS
HAVE THIS UNRELIEVED SUFFERING
WHICH MAY WELL RELATE TO THE
AMYGDALA RESPONSE THAT WE'VE
BEEN TALKING ABOUT BECAUSE WE
KNOW THAT OPIOIDS ACTUALLY
MODULATE FUNCTION IN THE
EMOTIONAL CIRCUITRY OF THE
BRAIN.
SO WHETHER OR NOT THEY'RE
ALLEVIATING THE PHYSICAL PAIN,
THE NOSE-SUSCEPTIVE CHRONIC
PROCESSING OF PAIN, THEY BE
ALLEVIATING SUFFERING IN THESE
PATIENTS SO WHAT DO WE DO ABOUT
THE DISCONNECT AT A SOCIAL LEVEL
AND ALSO, I THINK THE HEAL
INITIATIVE CAN BRING TO BEAR
FORCES TO ADDRESS THIS EMOTIONAL
SUFFERING THAT COMES ALONG WITH
PAIN?
>> I THINK IT WOULD BE GREAT TO
HEAR WHAT OTHERS SAY.
I WOULD--I THINK YOUR COMMENTS
ARE RIGHT ON BUT THE WAY I THINK
IS THAT THERE'S A PREVENTATIVE
TYPE OF APPROACH.
SO HOW DO YOU MANAGE CHRONIC
PAIN KNOWING THAT CHRONIC
OPIOIDS ARE NOT GOING TO BE
EFFECTIVE.
THAT'S 1 SET.
I THINK THE OTHER SET IS PEOPLE
WHO HAVE GONE TO THE DOCTORS AND
THEY SAID, I JUST CAN'T STAND IT
ANYMORE, IT'S WORSE THAN EVER
AND I NEED SOMETHING AND THEY
GET OPIOIDS AND THEY COME BACK
AND THEY SAY, MY PAIN IS
TERRIBLE, CAN I GET MORE OPIOIDS
AND THEY COME BACK, MY PAIN IS
TERRIBLE AND BUT NOW, I CAN'T
GET OFF THE OPIOIDS, FIELD
FUNCTIONS COME DOWN OFF THE
OPIOIDS, NOW THE PAIN GETS WORSE
SO I THINK THAT THAT--THIS
PROGRAM WE HAVE NOW START LOOK
BEING AT HOW YOU MANAGE PAIN IN
PEOPLE WHO ARE ON OPIOIDS, THIS
HAS TO BE CUSTOMIZED TO THE
POINTS THAT YOU MADE AND IN
TERMS OF POLITICS WE JUST HAVE
TO OBJECTIFY THE ISSUE, THE
ISSUE IS HOW DO YOU GET THE
PATIENT TO THE HIGHEST
FUNCTIONAL LEVEL PERIOD AND
IF--YOU KNOW IF IN SOME PEOPLE,
IT MAY MEAN THAT THEY NEED TO
CONTINUE ON OPIOIDS.
AND THERE ARE SOME PEOPLE WHERE
THE OPIOIDS, YOU KNOW MAY HELP
THEM IN TERMS OF THE PAIN AS
WELL.
SO I THINK THAT'S SPACE WHERE
IT'S THE MOST CHALLENGING TO GO
INTO, BUT I THINK THAT'S WHERE
WE'RE GOING NOW WITH THESE NEW
PROGRAMS.
>> YEAH, AND I KNOW YEAR JUST
GOING TO COMMENT ON THAT THAT
CERTAINLY THERE IS A NEW
INITIATIVE, THE EMPOWER
INITIATIVE THAT WILL BASICALLY
DWELL ON THIS VERY CHALLENGING
PROBLEM OF PEOPLE THAT ACTUALLY
HAVE CHRONIC PAIN AND AT THE
SAME TIME ARE ADDICTED TO THE
OPIOIDS, HOW DO YOU PROPERLY
MANAGE THEM BECAUSE THE OPIOIDS
MAY BE IN SOME INSTANCES, THE
ONLY INTERVENTION THAT RELIEVES
THEIR PAIN AND AT THE SAME TIME
IT IS ACTUALLY CAN LEAD TO LOSS
OF CONTROL.
SO THEY THERE ARE WAYS THAT 1
CAN ACTUALLY, THAT CLINICIANS
HAVE BEEN DEALING WITH THIS
ISSUE, BUT IT'S A SPACE THAT
OVERALL IN TERMS OF RESEARCH HAS
BEEN VERY POORLY INVESTIGATED.
BUT I THINK YOU WILL HEAR LATER
ON ABOUT EMPOWER INITIATIVE.
>> ALLAN?
>> NORA THANK YOU FOR EVEN
HINTING THAT THERE ARE SOME
PEASHTS WHO DO RESPOND
POSITIVELY AND I WE WANT TO BE
CAREFUL TO MAKE THE GENERAL
ASSUMPTIONS THAT OPIATES DON'T
WORK, AND FOR CANCER PATIENTS,
PARTICULARLY WITH CANCER PAIN,
YOU DO NOT WANT TO TAKE AWAY
THEIR OPIOIDS, AND TO ASSUME
THAT EVERYBODY'S THE SAME IS A
BIG MISTAKE.
WE NEED TO UNDERSTAND THE
GENETICS OF THE INDIVIDUALS,
QUESTIONS OF TOLERANCE, SOME
PATIENTS BECOME TOLERANT, OTHER
PATIENTS STAY ON THE SAME DOSE
AND WE DON'T KNOW ENOUGH ABOUT
SOME OF THESE MECHANISMS, BUT I
THINK TO JUST MAKE THE GENERAL
ASSUMPTION, THROW AWAY THE
OPIOIDS AND COME UP WITH
SOMETHING ELSE, THAT'S PROBABLY
LITERALLY THROWING THE
PROVERBIAL BABY OUT WITH THE
BATH WATER.
>> ALLAN, THANKS FOR MAKING THAT
POINT BECAUSE THE REALITY IS
THERE ARE SOME PEOPLE THAT HAVE
TRIED EVERYTHING AND THE OPIOID
MEDICATIONS IS THE ONLY THING
THAT IMPROVES THEIR PAIN AND
WITHOUT IT THEY ARE VERY HIGH
RISK OF SUICIDE, SO I THINK THAT
THE NOTION IS WE LIKE TO
POLARIZE THINGS AND SAY EITHER
THEY ACTUALLY BECAME VERY OPEN
IN HOW WE OVERPRESCRIBED BUT ON
THE OTHER 1 WE CAN INSERT
INSTANCES WHERE THEY CAN BE USED
IN A SAFE WAY THAT CAN HELP THE
PATIENTS AND SO, I GUESS THE
PART OF THAT RESEARCH THAT WE'RE
AIMING TO DO IS UNDERSTANDING
UNDER WHAT CONDITIONS AND FOR
WHOM OPIOID MEDICATIONS MAY HAVE
A VALUE MANAGEMENT OF CHRONIC
PAIN FOR A WHILE AS PART OF A
MULTIPRONGED APPROACH THAT IS
NOT JUST RELYING ON THE OPIOID
BY ITSELF.
AND THE EXPECTATIONS, ACTUALLY
TRAINING PEOPLE OF WHAT
EXPECTATIONS THEY SHOULD HAVE
REGUARDING WHAT THE OPIOID
MEDICATION SHOULD DO FOR THEM,
SO I AGREE WITH YOU AND I AM
CONCERNED THAT JUST THE PENDULUM
GOING BACK AND FORTH IS NOT THE
RIGHT WAY TO ADDRESSING THE
BASICALLY WHAT THE DATA IS
SHOWING US TO OPTIMALLY HELP
PATIENTS.
>> I WOULD ONLY ADD NORA AND
WALTER THAT WHEN WE STARTED, I
THINK THERE WAS A SENSE THAT WE
REALLY DIDN'T WANT TO BE
STUDYING OPIOIDS, WE WANTED TO
BE SUPPORTING RESEARCH TO
PROVIDE ALTERNATIVES,
PHARMAICOLOGICAL ALTERNATIVES
AND COMING FROM THE PINE LINE
AND NONPHARMAICOLOGICAL
ALTERNATIVES AND I THINK AS WE
HAVE MATURED AS AN INITIATIVE,
WE'VE NOW BEEN ABLE TO TAKE ON
SOME OF THESE MORE COMPLEX
QUESTIONS.
WHAT HAPPENS WHEN SOMEONE IS ON
HIGHER DOSE OPIOIDS, WHAT FORMS
OF TREATMENT FOR A GIVEN PATIENT
OR A PATIENT WITH A GIVEN
HISTORY.
SO I THINK YOU WILL SEE SOME OF
THE RECENT INVESTMENTS IN HEAL
AND THEN SOME OF THE DISCUSSIONS
WE'RE HAVING CONSIDERING FUTURE
INVESTMENTS TO REALLY START TO
MOVE INTO THIS SPACE AND EMPOWER
IS 1 EXCELLENT EXAMPLE THAT
THERE ARE OTHER IDEAS OUT THERE
TO GET INTO THIS MIDDLE SPACE
THAT WE WEREN'T ABLE TO TACKLE
RIGHT AWAY.
>> YEAH, NO, I HAPPY YOU BRING
THIS UP BECAUSE ALSO THE OTHER
ISSUE IS THAT NOT ALL OPIOID
AGANIST DRUGS THAT ARE THE SAME
AND THERE ARE SOME OPIOID
AGANIST THAT HAVE ADVANTAGES
THAT MAY HAVE MECHANISM OF
ACTION MAY OFFER PROTECTION
AGAINST ADDICTION AND MAY ENABLE
TO PROPERLY MANAGE PAIN AND
THERE IS ONGOING RESEARCH IN
MULTIPLE INSTITUTES AND IN THE
FIELD TOO AS PART OF THE HEAL OF
ALTERNATIVE OPIOIDS THAT MAY
HAVE ANALGESIC EFFECTS AND HAVE
MUCH LESS LIABILITY FOR
ADDICTION.
SO THAT IS--SORT OF AN YIR THAT
WE SHOULD NOT NEGLECT BECAUSE
OBVIOUSLY THESE ARE THINGS THAT
MAY PROVIDE US WITH SOLUTIONS IN
A SHORTER TIME PERIOD THAN
COMPLETELY DIFFERENT MOLECULES
TO HELP [INDISCERNIBLE].
WHICH IS OF COURSE WHERE WE WANT
TO GO BUT IN THE MEAN TIME WITH
EXPERIMENTING WITH WAYS FOR
OAPPROXIMATE PILOT PROJECTOID
DRUGS OR DIFFERENT
PHARMAICOLOGICAL STUDIES IN A
SAFE BENEFICIAL WAY THAT'S GOOD
FOR PATIENTS.
>> HI, THIS IS WALLY I WOULD
LIKE TO GET ON THE RECORD FROM
WALTER, A STATEMENT REPEATED AND
THEN AN EXPLANATION FOR THE
STATEMENT WHICH I AGREE WITH:
LARGE PHARMA HAS IN GENERAL
ABANDONED THERAPIES FOR PAIN IN
THE LAST 20-30 YEARS.
I HEARD YOU SAY THAT.
I WOULD LIKE YOU TO REPEAT THAT
AND TELL ME WHAT YOU THINK IS
DRIVING IT?
>> OTHERS ON THE CALL MIGHT KNOW
BETTER BUT THEY THINK WHEN WE
INITIALLY STARTED THE HEAL
INITIATIVE, WE BROUGHT BIG
PHARMA TO THE TABLE AND THEY
TOLD US DIRECTLY THAT THEY
WERE--HAD CLOSED DOWN WITH THE
EXCEPTION OF LILLY, I THINK
LILLY IS THE 1 EXCEPTION THAT I
KNOW IT THAT THEY CLOSED DOWN
PAIN PROGRAMS AND WERE NOT
REALLY CONSIDERING OPENING THEM
UP AGAIN.
AND THE REASONS ARE PROBABLY
COMPLEX, BUT THE MAIN REASONS
WERE FAILURE OF GOING FROM THE
ANIMAL MODELS INTO THE HUMAN
CONDITION, HIGH EXPECTATION ON
BEHALF OF THE FDA, THAT THESE
THINGS WOULD HAVE TO BE VERY
SAFE BECAUSE AS WE MENTIONED IF
1 IN 20 PEOPLE IN THE U.S. HAVE
PAIN, 1 IN 20 PEOPLE ARE TAKING
MEDICINE, THAT'S TREMENDOUS
SAFETY ISSUE AND IT HAS TO BE
SAFE AND THEY WERE CERTAINLY
BURNT BY SOME OF THE
NONSTEROIDALS THAT WERE FOUND TO
HAVE CARDIAC EFFECTS AND HAD TO
COME OFF THE MARKET.
AND I THINK THOSE--I MEAN YOU
COULD MAKE A LOT OF MONEY,
THEREYA NO QUESTION IF YOU HAVE
A MORE EFFECTIVE PAIN MEDICINE,
SO IT'S NOT--THE MARKET IS THERE
BUT THE SUCCESS RATES OF GOING
OUT AND GETTING SOMETHING
APPROVED AND THEN KEEPING IT
APPROVED SO BIAX WAS APPROVED
AND THEN IT WAS TAKEN OFF, SO
THOSE ARE THE MAIN THINGS AND
YOU KNOW WHAT I'VE SEEN IN
INDUSTRY IS THAT WHEN YOU HAVE A
BUNCH OF FAILURES, THEN THE
WHOLE FIELD HAS A BLACK MARK ON
IT AND IT'S REALLY HARD TO GET
THAT BLACK MARK OFF YOUR BACK.
CERTAINLY IN STROKE, I COULD
TELL YOU THE SAME THING HAPPENS
TO STROKE IN THE LATE 1990S,
2000S.
THERE ARE NO PHARMA SUITICAL
COMPANIES INTERESTED IN STROKE
EVEN THOUGH IT'S THE THIRD
LEADING CAUSE OF DEATH.
ANYWAY, ALLAN, PROBABLY CAN--
>> YEAH, SO I THINK THE NOTION
THAT PHARMA LOST INTEREST IS
SOMETHING THAT WAS RELATIVELY
QUITE A FEW YEARS AGO NOW AND
THEY'RE SLOWLY COMING BACK.
NOVARTIS CERTAINLY IS INVESTING
AND FOLLOWING UP EITHER IN THEIR
OWN LABS OR INVESTING QUITE
HEAVILY IN SMALL COMPANIES.
REMEMBER THAT LILLY AND PFIZER
HAD--THEY REALLY HAD WONDERFUL
RESULTS WITH ANTIBODIES TO NERVE
GROWTH FACTOR, UNFORTUNATELY,
THERE WERE SOME SIDE EFFECTS
THAT THE FDA SAID THEY WOULD NOT
APPROVE THE DRUG.
PFIZER AND LILLY ARE NEEDLESS TO
SAY UNHAPPY AND MAY BE APPEALING
BUT THE POINT IS THAT THEY--THIS
WAS A MAJOR INVESTMENT BY
PHARMA.
IT IS TRUE THEY BACKED OFF
BECAUSE OF FAILURES, ISSUES OF
TRANSLATION FROM THE PRECLINICAL
STUDIES.
PAIN IS A TOUGH 1 IN THAT
PATIENTS DO RESPOND TO PLACEBOS
AND IT'S GOT TO BE BETTER THAN A
PLACEBO SO THAT I CANS THE
CHALLENGE--SO THEY SAID LET'S
PUT OUR MONEY SOMEWHERE ELSE BUT
I THINK THAT'S CHANGING AND
THEY'RE COMING BACK I REMAIN
OPTIMISTIC THAT THEY'RE--THAT
THEY WILL STAY IN THE FIELD.
>> OKAY.
>> IT'S NOT A LARGE PHARMA BUT
WE HAVE WITNESSED THROUGH HEAL,
A REALLY INCREDIBLE BLOSSOMING
OF SMALL BUSINESSES WITH IDEAS.
MAYBE EARLIER IN THE PIPELINE,
BUT IDEAS FOR TREATING PAIN AND
ADDICTION AND I'VE BEEN REALLY
IMPRESSED JUST OVER THE PAST
YEAR OR 2, HOW MANY DIFFERENT
TYPES OF HIGH QUALITY
APPLICATIONS WE RECEIVE FROM THE
SMALL BUSINESSES.
SO I ECHO ALAN'S HOPEFULNESS
ALTHOUGH IT'S NOT--IT'S STILL
NOT LILLY AND PFIZER.
BOB, HAVE YOU A QUESTION?
>> YEAH, I WAS GOING TO SAY SOME
OF WHAT ALAN JUST SAID BUT I
WOULD LIKE TO ADD TO THAT, BACK
TO WALTER'S COMMENT ABOUT THE
CONCERNS OF ANY POTENTIAL RISKS
LIKE THE HIGH BAR FOR SAFETY
BECAUSE OF A VERY LARGE NUMBER
OF PATIENTS AND I THINK 1 THING
THAT WE AS A SOCIETY NEED TO
REALLY BE MINDFUL OF IS THE RISK
OF PROVIDING NOTHING BECAUSE WE
SEE WHAT HAPPENS WITH THE SAFETY
BAR THAT WE HAVE.
I MEAN WE HAVE MANY DRUGS ON THE
MARKET THAT ARE SHOWN TO BE VERY
DANGEROUS.
THEY'RE STILL ON THE MARKET
BECAUSE THEY DO PROVIDE PAIN
RELIEF.
SO THE SAFETY BAR SHOULD BE
SAFER THAT OPIOIDS AND THAT WILL
DECREASE RISKS THAT WILL PROVIDE
HARM REDUCTION, OBVIOUSLY
THERE'S POTENTIAL ADICKAL RISKS
WITH ANY NEW MEDICATION THAT BUT
CONVERSATION NEEDS TO BE
RETHOUGHT IN TERMS OF HOW THE
FDA IS ACCOMPLISHING THIS SAFETY
BAR BECAUSE IF WE CAN MOVE
PEOPLE AWAY FROM NEEDING OPIOIDS
AT ALL, THAT HORSE IS OUT OF THE
BARN, WE KNOW THAT BUT I THINK
THAT'S A VERY IMPORTANT CONCEPT
FOR THIS GROUP AND FOR ALL OF US
TO KEEP IN MIND.
>> AND THE STRATEGY WE HAVE
TAKEN WITH AFTER DISCUSSION WITH
THE FDA, IS TO GO AFTER PAIN
CONDITIONS THAT, YOU KNOW ARE
MORE CONFINED AND WHICH HAVE
POOR TREATMENTS AVAILABLE AND
THERE, YOU KNOW IF IT'S
CONDITION X AND THERE'S
NOTHING--THEN THEY CAN--THEN THE
BAR CAN COME DOWN BECAUSE IT HAS
TO BE A BALANCE BETWEEN THE
SUFFERING AND THE RISK.
I THINK THE FDA IS MOST
CONCERNED IF IT'S GOING TO BE
SPLG THAT EVERYBODY IN THE
COUNTRY WILL TAKE.
SO OUR STRATEGY IS TO GO AFTER,
YOU KNOW SPECIFIC DISORDERS AND
NOT OVERGENERALIZE IT FOR US ON
EVERYTHING AT THIS POINT IN
TIME.
>> KRISTIN?
>> YEAH, I TOTALLY UNDERSTAND
THAT PERSPECTIVE WALTER BUT I
ALSO WORRY AND I KNOW YOU AND I
AND OTHERS TALKED ABOUT THIS A
LOT IS THAT WE HAVE DOZENS, YOU
KNOW, MANY MORE THAN DOZENS PAIN
CONDITIONS AND IS IT REALLY
FEASIBLE TO GO AFTER THEM 1 BY 1
BY 1 AND HOW LONG IS THAT GOING
TO TAKE BEFORE WE'RE ACTUALLY
ABLE TO DEVELOP THERAPIES THAT
CAN HELP PEOPLE WITH ALL OF
THESE DESPERATE PAIN CONDITIONS
OR DO YOU TAKE THE APPROACH FROM
A MORE MECHANISTIC PERSPECTIVES
WHERE WE DEVELOP THERAPIES
BECAUSE WE KNOW THERE'S
DIFFERENT PHENOTYPES WITHIN EACH
PAIN CONDITION, THAT RANGE IN
SYMPTOMS AND SIGNS AS WELL AS
SEVERITY.
AND I KNOW WE'RE THINKING ABOUT
THIS AND FUNDING STUDIES IN THE
BASIC SCIENCE APPROACH TO LOOK
AT MECHANISMS, RIGHT?
THAT'S KIND OF THE HOLY GRAIL OF
PAIN RESEARCH BUT I JUST WONDER
WHAT YOU THINK ABOUT THAT TYPE
OF APPROACH.
IS IT REALLY FEASIBLE THAT WE'RE
GOING TO BE ABLE TO DEVELOP
THERAPIES, THAT ARE REALLY GOING
TO TARGET THIS HUGE PERCENTAGE
OF PEOPLE IN AMERICA ACROSS THE
WORLD BUT HAVE CHRONIC PAIN IF
WE ONLY GO CONDITION BY
CONDITION.
>> DEFINITELY WOULD TAKE A LOT
LONGER.
IT'S THE GENERALIZATION.
SO YOU COULD ENVISION, YOU KNOW
IF WE HAVE THE PROGRAM NOW IN
ARTHRITIS WHERE WE'RE BLOCKING
PARTICULARLY LYMPHOCYTE ENTERING
THE JOINT SPACE AND THE DRUG
WOULD PREVENT THAT.
SO THAT'S A SPECIFIC CONDITION
BUT IF IT WORKED THERE, WE WOULD
SUSPECT IT MIGHT WORK IN OTHER
JOINTS.
SO WOO GO FROM KNEE TO OTHER
JOINTS BUT IT WOULD BE A
RATIONAL JUMP FROM 1 CONDITION
TO ANOTHER.
IF YOU GO VERY CENTRAL, THE
CENTRAL NERVOUS SYSTEM, THEN,
YOU KNOW YOU SHUT OFF THE
SUFFERING DUE TO PAIN NO MATTER
WHAT IT IS, AND THAT YOU KNOW IF
IT'S AN INVASIVE PROCEDURE, TELL
BE A SMALL POPULATION BECAUSE
TELL ONLY BE THOSE WITH THE
WORST TYPE OF PAIN, BUT IT WOULD
BE A MAJOR ADVANCE IF WE COULD
DO THAT FOR PEOPLE WHO ARE
REALLY DESPERATE.
SO I THINK, YEAH, THE MAGIC
BULLET IDEA, I'M NOT TOO
ENTHUSIASTIC THAT THAT'S GOING
TO BE HELPFUL.
I THINK THAT'S WHAT OPIOIDS ARE.
BUT THAT'S JUST MY OPINION.
>> NO, I AGREE, I AGREE.
I THINK THE IDEA IS THAT WE
CONTINUE TO DEVELOP MECHANISM
BASED TARGETED THERAPIES FOR
INDIVIDUAL CONDITIONS LIKE THE
EXAMPLE YOU JUST GAVE AND AS THE
BASIC SCIENCE CONTINUES TO
PROGRESS AND WE SEE THERE ARE
GROUPS OF PATIENTS WITHIN
CONDITIONS THAT HAVE SIMILAR
MECHANISMS ACROSS CONDITIONS
THAT THOSE THERAPIES ACTUALLY
CAN BE APPLIED, YOU KNOW TO
OTHER POPULATIONS, I DON'T THINK
THERE'S MUCH INCENTIVE FOR
PHARMA TO THEN REPEAT ALL THOSE
STUDIES IN ANOTHER POPULATION,
THEY JUST RELY THAT IT WILL BE
USE TD OFF-LABEL BUT I JUST, YOU
KNOW I UNDERSTAND THE ISSUES AND
PERSPECTIVES, I APPRECIATE YOUR
PERSPECTIVE ON THAT IT JUST
MAKES ME THINK IS THIS A
REALISTIC AND PRAGMATIC APPROACH
THAT WILL GO 1 CONDITION, 1
CONDITION, SO HOPEFULLY AS A
THERAPEUTICS ADVANCE AND WE
UNDERSTAND MECHANISMS BETTER
LIKE WE SAID WE CAN USE MULTIPLE
TARGETED THERAPY ACROSS
DIFFERENT CONDITIONS OR
SUBPOPULATIONS WITHIN
CONDITIONS.
>> WE'RE A LITTLE BIT OVERTIME
IN THAT WE'RE SUPPOSED TO TAKE A
15 MINUTE BREAK BEFORE WE
COMMENCE DISCUSSION OF CONCEPTS
IN THE CLOSED SESSION AT 12:45.
SO--SO THAT WE CAN RETAIN A
SHORT BREAK FOR FOLKS TO GET UP
AND WALK AROUND BEFORE WE START
THAT SECTION, ALLAN AND NORA DO
HAVE YOU KIND OF CLOSING WORDS
IF ARE THIS DISCUSSION.
>> YEAH, MY QUESTION HAD TO DO
WITH THE NOTION OF SINCE WE HAVE
THE EXPERTS HERE, I AM HEARING
WHAT YOU ARE SAYING AND I
BASICALLY WRESTLE WITH IT WITH
THE URGENCY OF GETTING TREATMENT
AND THE RECOGNITION THAT MORE
AND MORE IS BIOTECH, AND NOT BIG
PHARMA WHICH IS SOMETHING WE'VE
SEEN WITH MEDICATIONS GOING INTO
THE CLINIC AND WHAT MORE COULD
WE PLAY WITHIN THE HEAL TO
ACTUALLY ACCELERATE THE
DEVELOPMENT OF THOSE BIOTECHS?
AND WE HAVE BEEN APPLYING THESE
IN THE DRUG ABUSE FIELD IN
GENERATING AND TRAINING
RESEARCHERS AND PARTNER BE WITH
VENTURE CAPITAL SO THAT NOW WE
HAVE FIELD OF BIOTECH THAT CAN
APPROACH THE PROBLEM OF
SUBSIDIARY STANCE DISORDERS AND
IT STRIKES ME THAT THIS APPROACH
COULD BE EXTRAORDINARILY
VALUABLE FOR PAIN, SO IF WE
EXPAND THE CAPABILITIES FROM
BIOTECH, WE COULD PROBABLY
ACCELERATE THE DEVELOPMENT OF
NEW THERAPEUTICS FOR PAIN AND
I'M PUTTING IT IN THE STABLE AS
A SUGGESTION OF POTENTIALLY
SOMETHING THAT WE COULD USE
SCALE MONEY FOR.
>> THANK YOU NORA, I THINK WE
HAVE GOOD IDEAS COMING YOUR WAY
TOWARD THAT GOAL.
ALLAN, CLOSING THOUGHTS?
>> NOW, OBVIOUSLY WE NEED TO
PUSH WITH THE PHARMAICOLOGICAL
APPROACHES BUT LET'S NOT FORGET
THE NONPHARMAICOLOGICAL, RIGHT?
THAT CAN NOT ONLY SORT OF HAVE
AN EFFECT ON NOSE-SUSCEPTION BUT
ALSO ON THE COMPLEXIVE FORM OF
PAIN AND SUFFERING IN ALL OF
THIS.
SO I THINK THIS IS A GREAT
DISCUSSION, I REALLY WANT TO
MAKE SURE THAT WE KEEP IN MIND
THAT THIS ALL HAS TO BE DONE IN
THE CONTEXT OF PUSHING AS HARD
AS WE CAN ON THE
NONPHARMAICOLOGICAL ASPECTS AS
WELL.
>> THANK YOU, HELENE, SO WITH
THEY WILL CLOSE THE OPEN PORTION
OF THE HEAL MULTIDISCIPLINARY
WORKING GROUP FOR MARCH, 2022
MEETING, THANK YOU VERY MUCH FOR
THOSE WHO TUNED IN WE WILL TAKE
A SHORT BREAK, SHORT BREAK,
RECONVENE AT 12:45 P.M. EASTERN
TIME AND BEGIN DISCUSSING SOME
OF THE FUTURE LOOKING IDEAS FOR
HEAL RESEARCH.
THANK YOU VERY