>> WELCOME, EVERYBODY TO THE
HELPING TO END ADDICTION
LONG-TERM OR HEAL INITIATIVE
MULTIDISCIPLINARY WORKING GROUP
MEETING.
THIS MEETING AND GROUP SERVES TO
PROVIDE INPUT TO THE VARIOUS
ADVISORY COUNCILS THAT WORK WITH
EACH OF THE INSTITUTES AND
CENTERS THAT ARE PART OF THE NIH
HELPING TO END ADDICTION
LONG-TERM OR HEAL INITIATIVE.
WE ARE VERY EXCITED TO HAVE
EVERYBODY JOIN US TODAY AND WE
ARE THRILLED TO BE ABLE TO HAVE
THIS MEETING IN ITS REGULAR
FORMAT AT ITS REGULARLY
SCHEDULED TIME.
YOU LEARN HOW TO APPRECIATE ALL
THINGS NEW WHEN YOU REALIZE YOU
CAN'T TAKE ANYTHING FOR GRANTED.
SO WELCOME EVERYBODY TO TODAY'S
MEETING.
WE ARE USING A DIFFERENT FORMAT
TODAY, WE ARE USING THE TEAMS
PREMIUM ACCOUNT, SO WE'RE GOING
TO MANAGE THINGS A LITTLE BIT
DIFFERENTLY.
I WANT TO TAKE A MOMENT TO TALK
A LITTLE BIT ABOUT THAT FROM A
HOUSEKEEPING PERSPECTIVE, WHEN
PEOPLE WOULD LIKE TO ASK
QUESTIONS YOU CAN RAISE YOUR
HAND AND THE ORGANIZERS WILL
MAKE SURE YOU ARE ABLE TO BE
UNMUTED AND TO SPEAK.
AND WE LOOK FORWARD TO A LIVELY
DISCUSSION AT EVERY POINT.
MY NAME IS AMY ADAMS, I SERVE AS
DEPUTY DIRECTOR FOR SCIENTIFIC
AND OPERATIONS FOR THE NATIONAL
INSTITUTE OF NEUROLOGICAL
DISORDERS AND STROKE AND IN THAT
CAPACITY I HELP TO SUPPORT THE
HEAL INITIATIVE IN A VARIETY OF
WAYS.
WE ARE LOOKING FORWARD TO INPUT
FROM THIS GROUP ARE TO HELP
ADVISE, HEAL AS WE MOVE FORWARD,
THERE WILL BE BOTH AN OPEN
SESSION OF THIS MEET BEING WHERE
WE TALK ABOUT OVERARCHING
PROGRAM AND POLICY ISSUES AROUND
THIS INITIATIVE AND THERE WILL
BE A BRIEF CLOSED SESSION,
PORTION OF THIS MEETING WHERE WE
TALK THROUGH AND GET INDIVIDUAL
INPUT ON SOME OF OUR
APPLICATIONS AND PORTFOLIOS.
>> HI, AMY CAN WE ASK ATTENDEES
ARE THERE OTHERS WHO CANNOT HEAR
THE MEETING?
IF YOU CAN PUT IN THE CHAT,
LET'S SEE IF WE CAN BRING --
LINDE DID YOU HAVE A COMMENT?
>> I WAS JUST GOING TO CLARIFY
THAT STRANGELY WHEN I FIRST CAME
IN, NO ACCESS TO THE AUDIO, IT
SAID YOU CAN NO LONGER ACCESS
AUDIO, SO WHEN I CAME BACK IN, I
WAS ABLE TO HEAR, SO, JUST I
WONDER WHETHER THAT'S SOMETHING
YOU'RE CONTROLLING ON YOUR END,
SO HOPE IT GETS WORKED OUT FOR
OTHERS.
>> THANK YOU.
THANK YOU ERCH FOR YOUR
PATIENCE.
>> ONE QUESTION IS: IS ANYBODY
USING A TEAMS APP THAT THEY GOT,
THEY JUST USED A LINK TO COME IN
AS OPPOSE TO A TEAMS APP ON YOUR
COMPUTER?
I'M WONDER FIGURE THAT'S THE
DIFFERENCE?
OKAY.
>> IT SEEMS LIKE A LOT HAS BEEN
RESOLVED.
SO SORRY ABOUT THAT EVERYONE.
>> OKAY.
>> THANK YOU SO MUCH AND THIS
REMINDS ME TO TAKE A MOMENT AND
THANK THE TEAM THAT HELPS TO
ORGANIZE AND SUPPORT THIS
MEETING, BOTH THE SCIENTIFIC AND
PROGRAM STAFF ACROSS THE MANY
INTUITYS AND CENTERS THAT ARE
PART OF THE HEAL INITIATIVE AND
ALSO THE STAFF THAT HELPED TO
MAKE SURE THAT THIS MEETING
ITSELF MOVES FORWARD AND TODAY I
WANT TO REEL KEEPSAKESLY
APPRECIATE RACHEL KELLY WHO I
THINK HAS STEPPED FORWARD AND
DONE SOME REAL HEROICS AS WE'RE
DEALING WITH THE SITUATION WHERE
WE HAVE MANY FEWER STAFF THAN WE
TYPICALLY DO SO THANK YOU RAICH
AND HE WILL THANK YOU EVERYBODY
ACROSS HEAL.
SO WITH THAT I DO WANT TO
ACKNOWLEDGE THAT WE HAD A
SCHEDULES CONFLICT WITH THIS
MEETING AND THE UNITED STATES OF
ASSOCIATION FOR THE STUDY OF
PAIN OR THE USA SP ANNUAL
MEETING SO I JUST WANT TO
APPRECIATE EVERYBODY WHO WAS
STILL ABLE TO ORGANIZE THEIR
TRAVEL SCHEDULE AND SQUEEZE IN
PARTICIPATING IN THIS MEETING.
WE REALLY APPRECIATE YOU AND WE
APPRECIATE THE INPUT THAT YOU
PROVIDE US AS YOU GUIDE THIS
INITIATIVE AS IT MOVES FORWARD.
SO WITH THAT, -- PLEASE?
I'M SORRY?
DID I MISS SOMEBODY?
>> I THINK IT MIGHT HAVE BEEN
BACKGROUND NOISE.
>> OKAY, VERY GOOD BUT WITH THAT
I'M HAPPY NOW TO HAND OFF TO
FEARLESS LEADERS TO WALTER
KOROSHETZ, AND DR. WILSON
COMPTON, DEPUTY DIRECTOR OF THE
NATIONAL INSTITUTE OF DRUG ABUSE
WHO ARE STEPPING IN ON BEHALF OF
DR. NORA VOLKOW, WHO THEY SERVE
TO LEAD THE INITIATIVE, THANK
YOU BOTH.
>> THANK YOU AIM EXPE THANKS
FOREM TUNING IN AND HOPE THE
MEETING IN CHICAGO GOES WELL,
SORRY WE CAN'T BE THERE.
I WANTED TO JUST EMPHASIZE HOW
IMPORTANT THIS GROUP IS AND THE
HEAL INITIATIVE IS.
YOU WILL HEAR FROM SOME I THINK
REALLY HIGH IMPACT PROGRAMS, THE
BACPAC PROGRAM WHICH IS RUN
PRIMARILY OUT OF NIAMS AND
DR. LINDSEY, AND WE ALSO HAVE
DR. LANG EVINE AND DR. VOLKOW,
AND THE HEAL INITIATIVE PUT US
IN A SPECIAL PLACE WHERE WE CAN
ADDRESS WHAT IS A TREMENDOUS
TRAGIC PROBLEM OF OVERDOSE
DEATHS IN THE U.S. AND THE KIND
OF BOOK-IN PROBLEM OF POOR PAIN
MANAGEMENT IN THE U.S. AND THESE
2 THINGS FEED TO EACH OTHER AND
BY WORKING TOGETHER, I THINK
WE'VE BEEN ABLE TO DO SOME
REALLY INNOVATIVE RESEARCH THAT
WOULD NEVER HAVE BEEN POSSIBLE
WITHOUT THE HEAL INITIATIVE.
NOW LOOKING TO THE FUTURE,
THINGS ARE CERTAINLY UNSETTLED
IN MANY INSTANCES HERE AT NIH, I
WILL REPORT OUT ON CHANGES THAT
OCCURRED AND POTENTIAL IMPACT ON
HEAL INITIATIVE, BUT I THINK
THAT YOU KNOW WE'VE --
CONGRESSIONAL STAFFERS HAVE
ASKED US QUESTIONS, SO HEAL IS
STILL ON THEIR RADAR SCREEN, AND
AND WE ARE HOPEFUL EVEN THOUGH
WE HAVE A C. R. CURRENTLY WHICH
MEANS WE ARE OPERATING UNDER THE
SAME FUNDING WE HAD LAST YEAR,
WE'RE LOOKING FORWARD TO
CONTINUING HEAL SHOULD THE
CONGRESS DEEM THAT FUNDING HIGH
PRIORITY TO THEM GOING FORWARD
INTO 2026.
AS YOU PROBABLY HEARD IN THE
PAPER HAS BEEN A LOT OF CHANGES
AND UPS AND DOWNS AT NIH WITH
REGARD TO A LOT OF THE
COMMUNICATIONS ON HOLD, STUDY
SECTIONS ON HOLD, BOARD OF
SCIENTIFIC COUNSELORS MEETINGS
AND ADVISORY COUNCIL MEETING
WERE ON HOLD, THOSE HAVE ALL
BEEN OPENED UP AND COUNCIL
MEETINGS ARE OCCURRING, STUDY
SECTIONS ARE WORKING REALLY HARD
TO WRAP UP ALL THE REVIEWS OF
ALL THE APPLICATIONS THAT ARE
COMING TO THE MAY COUNCILS BUT
THERE ARE SOME CHANGES THAT NIH
IS CONSIDERING AND 1 OF THEM,
THAT'S GOING TO AFFECT HEAL IS A
MOVEMENT OF ALL REVIEW TO THE
CENTER FOR SCIENTIFIC REVIEW AND
OUT OF THE INSTITUTES WHO
REVIEWED A NUMBER OF DIFFERENT
HEAL PROJECTS.
THE BIG CHANGES WERE AS AMY
HINTED IN THE PERSONNEL, SO
NINDS HAS LOST ABOUT 187 STAFF
MEMBERS IN THE LAST COUPLE OF
MONTHS AND SO IT'S JUST A LOT OF
THINGS THAT WE HAVE HIGH
EXPECTATIONS FOR OURSELVES BUT
UNFORTUNATELY WE'RE JUST NOT
GOING TO BE ABLE TO OPERATE AT
THE SAME LEVEL THAT WE DID
BEFORE AT LEAST IN THE
SHORT-TERM.
AND IN TERMS OF THE HEAL
INITIATIVE --
>> IS WALTER MUTED?
>> I THINK HE MUTED.
WALTER, I THINK YOU'RE MUTED.
>> WALTER CAN YOU UNMUTE.
>> OKAY, CAN YOU HEAR ME NOW?
>> YES.
>> OKAY, WHERE DID YOU LOSE ME?
>> IT'S WHEN YOU WERE
TRANSITIONING TO THE SLIDES.
I DON'T THINK WE MISSED MUCH.
>> OKAY, SO THE SLIDE HERE SHOWS
THE PEOPLE WHO WERE IN THE
OFFICE OF PAIN POLICY AND
PLANNING AND ALL WERE LET GO,
THESE FOLKS WERE REALLY
ESSENTIAL IN BUILDING HEAL AS
YOU REMEMBER MOST OF THE STAFF
WERE IN THE OFFICE OF THE NIH
DIRECTOR TO BEGIN WITH AND THEN
WERE MOVED TO NINDS, BUT WE LOST
ALL THEM AND SO THAT REALLY PUTS
US AT SOME SIGNIFICANT
DISADVANTAGE, IT'S 10 REALLY
SURVEYS PUSH PEOPLE MOVING HEAL
FORWARDOT PAIN SIDE.
OF COURSE, WE HAVE YOU KNOW
PROGRAM DIRECTORS AND PEOPLE IN
ALL SORTS OF DIFFERENT AREAS
THAT ARE TRYING TO PITCH IN,
HOWEVER, BESIDES THE HEAL
PROGRAM, WE ALL LOST ALL OUR
COMMUNICATIONS PEOPLE, WE LOST
ALL OUR PEOPLE WHO WORKED IN
SCIENCE POLICY AND PLANNING AND
1 OF THE BIGGER PROBLEMS IS
THAT, A LOT OF THE STAFF THAT
ARE INVOLVED IN OUR CONTRACTS
AND NIDA AS WELL HAVE ALSO BEEN
LOST, SO WE HAD TO REDUCE OUR
CONTRACTS BY 35% AND OF NOTE, A
LOT OF THE COMMUNICATIONS WE
WERE DOING WERE DONE WITH THESE
CONTRACTS AND IT'S NOT CLEAR HOW
WE WILL BE ABLE TO DO THOSE,
ALTHOUGH THE PLAN I THINK AT NIH
IS TO CONSOLIDATE A NUMBER OF
DIFFERENT FUNCTIONS SUCH AS
POLICY AND COMMUNICATIONS AND
ONCE THAT'S DONE, THEN I THINK
WE WILL BE UP AND RUNNING AT YOU
KNOW FULL SPEED AGAIN, BUT IN
THE MEAN TIME, I THINK THE
EFFECT ON HEAL IS THAT WE --
THERE ARE CERTAIN THINGS THAT
ARE REALLY GOING TO BE DIFFICULT
FOR US TO DO BECAUSE OF BAND
WIDTH ISSUES, LOSS OF CONTRACTS
SO WHAT WE'RE PROPOSING IS
ACTUALLY TO DECREASE THE MDWG
MEETINGS AT LEAST IN THE
SHORT-TERM, YOU KNOW WE HOPE TO
HAVE, YOU KNOW 1 OTHER MEETING
THIS YEAR, BUT I THINK WE HAVE
TO CUT BACK ON THE ABILITY TO DO
MEETINGS AND THEN, ALSO, YOU
KNOW WE WERE GOING TO TRY TO GET
NEW MEMBERS ON THE MDWG AND WILL
STILL BE WORKING ON THAT BUT
THINGS HAVE REALLY SLOWED DOWP
IN THAT SPACE, TOO THE OTHER
PROBLEM FOR HEAL ON THE PAIN
SIDE IS THAT THE -- WE HAD A
CONTRACT WITH AN EDUCATIONAL
COMPANY TO SET UP WHAT'S CALLED
THE PURPOSE NETWORK, IT WAS
HUGELY SUCCESSFUL AT DEVELOPING
A PAIN COMMUNITY ACROSS THE
COUNTRY DEVELOPING SOCIAL
COMMUNICATIONS AMONG EARLY STAGE
INVESTIGATORS AND DEVELOPING
MENTORS PROGRAMS, SENDING OUT
INFORMATION ABOUT PAIN AND
HOLDING WHAT I THOUGHT WERE
REALLY EXCELLENT MEETINGS OF THE
EARLY STAGE INVESTIGATORS AND
THEIR MENTORS, AND THAT CONTRACT
WAS TERMINATED AND SO WE DON'T
HAVE THE ABILITY TO KIND OF DO
THOSE -- CARRY OUT THOSE
FUNCTIONS ANYMORE.
SO I THINK THE MAIN POINT I
WANTED TO MAKE IS THAT WE AT
NINDS AND THE OTHER PAIN
INSTITUTES IS -- I'M SURE WILSON
WILL ALSO TALK, IS USE THE STAFF
WE HAVE REMAINING TO FOCUS ON
THE REAL CRITICAL BUSINESS OF
WORKING WITH INVESTIGATORS TO
GET GRANTS IN, SYSTEMS ARE
CHANGING THERE, SO IT'S VERY
CONFUSING VERY IT ON THE OUTSIDE
SO TO HAVE OUR PROGRAMS
DIRECTORS WITH PEOPLE WHO WANT
TO SUBMIT GRANTS AND GET THOSE
GRANTS REVIEWED PROPERLY AND
PRESENTED TO COUNCILS AND THEN
WORK TO GET GRANTS FUNDED, I
THINK THAT WE REALLY HAVE TO
SHRINK OUR EFFORTS INTO THAT
CORE ACTIVITY AT LEAST IN THE
SHORT-TERM AND WITH HEAL WE WERE
ABLE TO DO SOME REALLY
INNOVATIVE PROJECTS THAT WE
HAVEN'T REALLY BEEN ABLE TO DO
FOR MANY OF OUR OTHER AREAS OF
RESEARCH BUT I THINK THAT WE
LOST THAT OPPORTUNITY NOW, AT
LEAST IN THE SHORT-TERM.
SO I HOPE YOU WILL BE PATIENT
WITH US AS YOU KNOW PAIN AND THE
POOR MANAGEMENT OF PAIN AND THE
NEED TO DEVELOP BETTER EFFECTIVE
THERAPIES ESPECIALLY FOR CHRONIC
PAIN IS SOMETHING THAT LIVES ON
AS A HIGH PRIORITY HERE FOR MANY
INSTITUTES, THERE'S 14 DIFFERENT
INSTITUTES IN THE HEAL PAIN
GROUP AND WE WILL CONTINUE TO
WORK, YOU KNOW WITH URIENCY AND
AS HARD AS WE POSSIBLY CAN TO
MOVE THAT RESEARCH FORWARD SO WE
CAN GET BETTER MANAGEMENT FOR
PEOPLE OUT THERE SUFFERING, BUT
THERE ARE CERTAINLY SOME THINGS
WE HAD DONE BEFORE IN HEAL THAT
ARE GOING TO BE VERY TOUGH TO DO
RIGHT NOW.
SO HOPEFULLY WE WILL GET
PATIENCE AND CONTINUE TO WORK
WITH US AND KEEP THE SCIENTISTS,
YOU KNOW, KEEP THEIR NOSE TO THE
GRIND STONE IN TERMS OF GETTING
THE WORK TONE BECAUSE THAT'S
REALLY THE IMPORTANT STUFF.
SO THOSE ARE THE KIND OF THINGS
I WANTED TO SET OUT FOR PEOPLE
AND I THINK I IF COULD MAKE
TURNOVER TO WILSON NOW AND HE
COULD A COUPLE UPDATES ON THE
OPIOID SIDE OF HEAL AND OF
COURSE THE CROSS CUTTING ASPECTS
THAT WE DO TOGETHER.
WILSON?
NTHANK YOU VERY MUCH, WALTER:
IT'S A PLEASURE TO BE
REPRESENTING THE NATIONAL
INNSITUTE ON DRUS DRUG ABUSE AND
FOR THE INSTITUTE AND IN
PARTICULAR NORA VOLKOW, WHO
SENDS HER APOLOGIES FOR NOT
BEING ABLE TO BE HERE THIS
MORNING AND I WILL SAY THAT I AM
GOING TO DO MY BEST ESPECIALLY
WITH A NEW VERSION OF TEAMS AND
HAS SOME THINGS THAT I'VE NEVER
USED BEFORE AND A LEARNING CURVE
FOR ALL OF US, SO THANK YOU VERY
MUCH FOR NEW TECHNOLOGY IN ALL
SECTORS OF THE PROGRAM.
CLERLY THERE'S TERRIFIC WORK ON
THE OPIOID OVERDOSE USE SECTION
THAT WE'RE PRIMARILY RESPONSIBLE
FOR, THE HEAL PAIN PROGRAM AND
THE VERY INNOVATIVE SHARED
PROGRAMS.
AMONG THE SHARED PROGRAMS I
CERTAINLY WANT TO HIGHLIGHT THE
AMERICAN INDIAN PROGRAM, THE
N CREW PROGRAM, AND HOW THE PAIN
AND OPIOID INTERSECT WITH EACH
OTHER.
LIKE ALL COLLEAGUES ACROSS NIH,
NIDA HAS HAD A NUMBER OF STAFF
WHO HAVE DEPARTED BOTH THROUGH
EARLY RETIREMENT AND THROUGH
REDUCTIONS IN FORCE SO THERE
HAVE BEEN A NUMBER OF LOSSES
THAT HAVE AN IMPACT ON ALL OF
OUR OPERATIONS.
AS WALTER MENTIONED THE
CONTRACTS OFFICE WHO MANAGE MANY
MANY OF THE RESEARCH ACTIVITIES
THAT ARE ESSENTIAL TO OUR
PROGRAMS HAVE BEEN NOTIFIED THAT
THEY'RE BASICALLY PART OF A
REDUCTION IN FORCE, SO THEY HAVE
A 2 MONTH ADMINISTRATIVE LEAVE
IN WHICH CASE, THEY'RE STILL
FOLLOWING THROUGH ON ESSENTIAL
ACTIVITIES BUT THEY'RE PREPARING
FOR THEIR DEPARTURE IN EARLY
JUNE AND SO FIGURING OUT HOW WE
WILL MANAGE OUR MYRIAD RESEARCH
CONTRACTS THAT ARE ESSENTIAL TO
OUR ACTIVITIES IS A MAJOR
IMPORTANCE TO US AND WE'RE
WORKING AS BEST WE CAN BEHIND
THE KEENS TO FIND ALTERNATIVES
TO KEEP THE ESSENTIAL ACTIVITIES
GOING.
WE'VE LOST A NUMBER OF STAFF IN
OUR JUSTICE PROGRAM, J COIN IN
PARTICULAR THAT I WOULD
HIGHLIGHT FOR YOU THAT WILL
REQUIRE US TO RETHINK HOW WE DO
OUR BUSINESS AND COME UP WITH
NEW WAYS THAT WILL RELY, I
EXPECT, A LITTLE MORE ON THE
EXTRAMURAL COMMUNITY BECAUSE WE
JUST WON'T HAVE ALL THE INTERNAL
STAFF TO MANAGE PROGRAM IT IS IN
THE SAME WAY AND TO MY MIND
THAT'S A BIT OF WHAT WALTER WAS
HIGHLIGHTING AT THE END THAT WE
WILL HAVE TO REALLY FOCUS ON OUR
CORE ACTIVITIES WHICH OF COURSE
INCLUDES GRANT MAKING AND BE
VERY CREATIVE AND FLEXIBLE, OUR
MAIN PRIORITIES CONTINUE TO BE
TO ADDRESS OPIOID USE DISORDER,
OVERDOSE AND PAIN WHICH I'M
REALLY PLEASED WE WILL BE ABLE
TO DO THAT AND CONTINUE TO DO
SO.
SOME HIGHLIGHTS THAT HAD ME
EXCITED IN THE LAST WEEK IN
PARTICULAR WAS THE LARGE SCALE
PRESCRIPTION DRUG SUMMIT, THIS
IS 1 THAT HAS TAKEN PLACE OVER
THE LAST NUMBER OF YEARS, THAT
WAS IMPLEMENTED BY HAL ROGERS A
CHAIR OF THE APPROPRIATIONS
COMMITTEE A NUMBER OF YEARS AGO
AND ULTIMATELY SOMEBODY WHO'S
BEEN 1 OF THOSE RESPONSIBLE FOR
APPROPRIATIONS AND ATTENTIONS TO
THE OPIOID CRISIS AND OPIOID USE
DISORDER BOTH IN HIS
CONSTITUENTS IN EASTERN KENTUCKY
AND NATIONALLY.
THIS MEETING HAS BEEN AN
OPPORTUNITY TO BRING TOGETHER
RESEARCHERS, POLICY MAKERS AND
PRACTITIONERS IN A MAJOR WAY,
AND THIS YEAR'S MEETING IN
TENNESSEE WAS NO EXCEPTION.
ARE I WAS VERY PLEASED TO SEE
THE NEW NIH DIRECTOR THERE AND
PRESENT, WE SAW PRESENTATIONS
FROM THE NEW AG PAM BONDI, AND
WE ALSO WERE ABLE TO SEE
SECRETARY KENNED EXPE THIS
INDICATES THAT THE CONTINUED
ATTENTION THAT THE OVERDOSE
CRISIS COMMANDS FOR THE
ADMINISTRATION AND WE HOPE THAT
IT AUGERS WELL FOR CONTINUED
SUPPORT FOR THESE PROGRAMS AND
WITH THAT I'M LOOKING FORWARD TO
THE REST OF THE MEETING AND I
WILL TURN IT BACK TO WALTER FOR
ANY WRAP UP AND PROBABLY AMY, I
THINK THAT'S NEXT.
>> YEAH, BEFORE WE SHIFTED, I
JUST WANT TO ALSO MENTION, I
JUST PUT IN THE CHAT THAT THE
GROUP HERE PRIOR TO THE
REDUCTION FORCE PUT TOGETHER A
REALLY GREAT ANNUAL REPORT ON
THE HEAL INITIATIVE WHICH IS
INTERESTING READING AND
RECOMMENDED TO ALL BUT IT HAS
REALLY SOUP TO NUTS EXPLANATION
OF WHAT'S BEEN DONE OVER THE
LAST YEAR AND GIVES YOU A SENSE
OF THE VALUE THAT HEAL BRINGS TO
THE TABLE.
GREAT.
SO I GUESS I WAS GOING TO PASS
IT TO AMY NOW TO INTRODUCE ANNA.
>> YEAH, DO YOU WANT TO TAKE A
MOMENT AND TAKE ANY QUESTIONS?
WALTER AND WILSON?
WE HAVE A JUST A COUPLE MINUTES.
>> ALWAYS FINE WITH ME.
>> OKAY.
>> DOES ANYONE -- ROB?
>> THANK YOU BOTH FOR THE
INTRODUCTION AND KIND OF UPDATE
ON EVERYTHING THAT'S ANYTHING
ON.
I KNOW IT'S VERY CHALLENGING AND
I THINK A LOT OF QUESTIONS ABOUT
WITH THE REDUCTIONS IN FORCE,
KIND OF THE PACE OF GETTING
GRANTS AWARDED AND THINGS LIKE
THAT, WHERE DO YOU PULL PEOPLE
AND HOW IS THAT GOING TO BE
IMPACTED BY WHAT'S GONE ON IN
TERMS OF THE STAFFING.
>> WELL 1 THING I'VE BEEN
RELIEVED THAT WE HAD A MAJOR
SLOW DOWN IN REVIEW BOTH IN
TERMS OF THE INSTITUTE'S REVIEW
AS WELL AS ALL THE MAJOR REVIEWS
TAKING PLACE IN CSR AND WE
WEREN'T SURE WE COULD HAVE
COUNCIL MEETINGS IN MAY WITH A
FULL RANGE OF APPLICATIONS.
ONCE THE ADMINISTRATIVE BARRIERS
TO THOSE MEETINGS WERE RELIEVED
AND THEY'VE BEEN SHUT DOWN FOR
MANY OF THE MEETINGS FOR ABOUT A
MONTH, MONTH IN A HALF, THERE
WAS A BACK LOG OF SOMETHING UP
ON THE ORDER OF 20 SOMETHING
APPLICATIONS AT NIH, THE GOOD
NEWS IS THAT THE REVIEW GROUPS
HAVE BEEN EXTRAORDINARILY
COOPERATIVE AND THEY'VE
RESCHEDULED VIRTUALLY ALL OF
THOSE MEET EXPTION WE FULLY
EXPECT ALL OF THOSE APPLICATIONS
TO BE VIEWED IN TIME FOR MAY
COUNCIL MEETINGS.
WE HAD SOME OF THE SAME SLOW
DOWN FOR AUGUST.
THE AUGUST DEAD LYNNS FOR THOSE
THAT ARE TYPICALLY END OF YEAR
RFA TYPE APPLICATIONS AND FOR
OCTOBER COUNCIL AND THOSE ARE
NOW BEING SCHEDULED TO CATCH UP
AND BE ABLE TO BE COMPLETED IN
TIME FOR US TO DO OUR FUNDING OF
THOSE EMPLOY THIS' AN EXAMPLE OF
HOW PEOPLE HAVE COME TOGETHER
AND BURN THE MIDNIGHT OIL WHERE
POSSIBLE AND WHERE FEASIBLE.
>> AND ROB DO YOU WANT TO SAY
ANYTHING ABOUT THE RESEARCH
RECOMMENDATIONS THAT I THINK WE
SHARED WITH THE MDWG BUT ARE
COMING TO THE COUNCIL IN MAY,
RIGHT?
>> YES, WE ARE -- WE ARE
PLANNING TO PRESENT THE RESEARCH
RECOMMENDATIONS AS PART OF THE
STRATEGIC PLANNING PROCESS TO
THE COUNCIL HERE IN A COUPLE OF
WEEKS, LOOKING FORWARD TO BEING
ABLE TO GET THAT PRODUCT PUSHED
FORWARD.
I KNOW TIMELINES ARE TIGHT FOR
THE FY27 SO THESE ARE SUPPOSED
TO INFORM THAT PROCESS, YEAH,
AND KATHLEEN AND I WILL BE
PRESENTING THAT AT THE NINDS
COUNCIL AND AT NIAMS AS WELL.
>> THANK YOU SO MUCH.
ALAN, I SAW YOUR HAND UP, TOO?
>> THANK YOU.
TWO QUESTIONS, 1 VERY PRACTICAL.
DESPITE ALL THE CUT BACKS AND
STAFFING, DO YOU EXPECT THAT THE
ACTUAL AMOUNT OF FUNDS GOING TO
RESEARCH WILL STAY THE SAME OR
WHAT YOU EXPECTED?
OR DO YOU ANTICIPATE THAT THAT
WILL BE CUT AS WELL?
THE OTHER QUESTION IS I KNOW OF
SEVERAL FOLKS WHO HAVE AN E-MAIL
THAT SAYS PENDING, PENDING AND
THEY'RE KIND OF CURIOUS AS TO
WHEN THERE WILL BE A RESOLUTION
OF THAT MESSAGE.
>> I CAN'T SPEAK TO THE LAST 1
BUT IN TERMS OF FUNDING AS
WALTER HIGHLIGHTED, THIS YEAR
WE'VE BEEN APPROPRIATED AS PART
OF A CONTINUING RESOLUTION WHICH
MEANS IT'S APPROXIMATELY THE
EXACT SAME AMOUNT AS LAST YEAR
SO THAT MEANS THAT WE HAVE, YOU
KNOW SIMILAR AMOUNTS OF FUNDS AS
WE HAD BEFORE, SO VERY GENEROUS
AMOUNTS.
WE'RE CERTAINLY -- WE'RE
CERTAINLY READING THE MEDIA AND
PAYING ATTENTION TO WHAT IS
POTENTIALLY IN STORE FOR NEXT
YEAR BUT UNTIL THE WHITE HOUSE
RELEASES THEIR BUDGET THE HOUSE
START HAVING HEARINGS AND MAKING
THEIR APPROPRIATIONS AND THE
SENATE, WE WILL JUST REMAIN
ALERT TO WHAT IS PROPOSED.
I DON'T KNOW, WALTER ANY OTHER
OBSERVATIONS?
>> NO, I THINK WE DON'T HAVE ANY
INSIDE TRADER INFORMATION ON
THIS 1 ALLAN.
AND IN TERMS OF THE GRANTS,
AGAIN THESE DECISIONS ARE NOT
COMING FROM NIH, BUT A NUMBER OF
GRANTS ARE ON HOLD, MAYBE THAT'S
WHAT YOU'RE TALKING ABOUT AND WE
DON'T HAVE CONTROL OF THAT
EITHER.
SO WE CAN'T REALLY HELP PEOPLE
VERY MUCH THERE.
THERE WAS 1 THING, 1 TECHNICAL
THING THAT MIGHT BE OF NOTE IS
THAT THE PAYMENT MANAGEMENT
SYSTEM WHICH ALLOWS GRANTEES TO
PULL MONEY DOWN WAS CLOSED FOR A
WHILE AS THEY WERE TRYING TO DO
UPDATES, I THINK NO 1 COULD
ACCESS MONEY FOR A LITTLE WHILE
BUT THERE ARE A NUMBER OF GRANTS
THAT ARE ON HOLD, CERTAIN
INSTITUTIONS, PRIMARILY, THERE
WERE A NUMBER OF GRANTS THAT
WERE TERMINATED BY THE PURPOSE
NETWORK --
>> I WAS REFERRING TO A COUPLE
OF K99S.
WHERE THEY GET A NOTE OF PENDING
AND OF COURSE, THEY'RE RATHER
CONCERNED.
>> THEY SHOULD REACH OUST TO
THEIR PROGRAM OFFICER WHO MAY
HAVE INFORMATION, THAT'S ALL I
CAN SAY.
IF THAT'S NOT SATISFACTORY THEN
YOU'RE WELCOME TO REACH OUT TO
LEADERSHIP OF THE INSTITUTE
WHERE THEY'RE ASSIGNED.
>> YEAH, THANK YOU.
THANK YOU.
AND I CERTAINLY AM ANSWERING
INTH OF THOSE QUESTIONS
PERSONALLY AND I'M SURE WALTER,
IS, TOO, BECAUSE EVERYBODY --
AND THE ANSWER MAY BE WE DON'T
KNOW BUT WE HAVE TO LOOK AT THE
SPECIFIC SITUATION TO BE ABLE TO
ANSWER THAT.
>> THANK YOU.
ERIC?
>> THERE I AM, GREAT.
I HAD A SIMILAR QUESTION TO
ALLANWITH RESPECT TO THE HEAL
FUNDING, I SEEM TO REMEMBER OVER
THE PAST SEVERAL YEARS IT WOULD
BE A DISCUSSION IN THESE
MEETINGS THAT TALKED ABOUT THE
FORWARD FUNDING COMMITMENTS OF
HEAL THAT THERE HAD BEEN A LOT
OF DOLLARS THAT HAD BEEN
APPROPRIATED FOR EXISTING
PROJECTS GOING FORWARD TO FUTURE
YEARS, HAS THAT CHANGED AT THIS
POINT?
>> ARE, ERIC, SO WE ALWAYS MAKE
PLANS, WE NEVER KNOW HOW MUCH
MONEY WE HAVE, SO THAT'S NOT
NEWS TO US AND I THINK IT'S JUST
A LITTLE BIT MORE UNCERTAINTY
THAN USUAL THIS YEAR GIVEN WHAT
WE'VE SEEN IN THE PAPERS BUT
AGAIN, WE DON'T HAVE ANY INSIDE
INFORMATION ON THAT.
IN GENERAL FROM JUST PAST
EXPERIENCE IF HEAL -- HEAL COMES
WITH A SPECIAL APPROPRIATION SO
EVERYTHING REALLY DEPENDS ON
WHAT CONGRESS WANTS TO DO IN
THAT SPACE GOING FORWARD.
YOU KNOW WE HAVE OPTIONS.
IF WE GET MORE MONEY WE ARE
USUALLY VERY GOOD AT DEVELOPING
REALLY GOOD PROGRAMS TO MAKE
VERY GOOD USE OF THOSE FUNDS.
IF WE HAVE DECREASED FUNDS THEN
WE HAVE TO LOOK TEARFULLY AT
WHAT THE TOP PRIORITIES ARE WITH
REGARD TO NOT JUST WHAT'S MOST
IMPORTANT BUT TIMES YOU KNOW
WHAT'S MOST TIME URGENT, WHAT
THINGS CAN WE PUT OFF, CAN WE
FUND INSTEAD OF 5 GRANTS IN A
GROUP, CAN WE FUND MAY ONLY BE
ABLE TO FUND 2, THOSE ARE THE
KIND OF THINGS WE DO.
WE DO ALSO, PARTICULARLY THIS
YEAR WITH THE UNCERTAINTIES
WE'RE INTERESTED IN MULTIYEAR
FUNDING GRANTS WITH FUNDS FROM
THIS YEAR, THAT ARE AVAILABLE
THAT WOULD MIGHT COVER US AND
NEXT YEAR IF IT'S -- IF THE
BUDGET'S DOWN.
SO WE HAVE A COUPLE OF OPGS WE
CAN WORK WITH HERE, BUT WE'RE
USED TO UNCERTAINTY, YEAH,
THAT'S NOT NEWS TO US.
>> ONE THING THAT PROVIDE A
LITTLE BIT OF FLEXIBILITY ERIC
IS THE DECLARATION OF A PUBLIC
HEGHT EMERGENCY START NOTHING
2017 ARE, THAT GIVES US A LITTLE
BIT OF ADMINISTRATIVE
FLEXIBILITY IN TERMS OF OUR
GRANT MAKING AND THAT WAS
CONTINUED IN MARCH, THE EVERY 90
DAYS THE SECRETARY HAS TO DECIDE
WHETHER EASE GOING TO CONTINUE
IT AND SECRETARY KENNEDY DID
RESIGN IT LAST MONTH.
>> GOOD.
THAT'S GOOD NEWS.
WELL SINCE THIS IS A PUBLIC
MEETING, JUST ON THE RECORD,
THIS HEAL INITIATIVE IS VITALLY
IMPORTANT TO ADADVANCE SCIENCE
AND THE HEALTH OF THIS NATION.
HAVING SEEN THE REALLY DRAMATIC
DECREASE IN OVERDOSE DEATHS, I
HAVE TO FEEL LIKE AT LEAST PART
OF THAT HAD TO DO WITH THESTS
HERE AND THE EXCELLENT WORK THAT
THE HEAL INITIATIVE HAS DONE.
SO I HOPE THE FEDERAL GOVERNMENT
CONTINUES TO SUPPORT CRITICALLY
IMPORTANT SCIENTIFIC INIAATIVE
THAT HELPS TO ALLEVIATE HUMAN
SUFFERING.
>> WE ALMOST ALWAYS REMIND OUR
EXTRAMURAL COLLEAGUES THAT YOU
HAVE THE ABILITY TO EXPRESS
THOSE THOUGHTS AND IDEAS TO YOUR
ELECTED REPRESENTATIVES IN A WAY
WE WILL PROVIDE ANSWERS TO
QUESTIONS AND INFORMATION BUT
YOU ALL ARE ABLE TO ADVOCATE IN
WAYS THAT YOU'RE CERTAINLY
WELCOME TO CONSIDER DOING SO.
>> LYNN?
>> I'M NOT SURE THIS IS AN
ANSWERABLE QUESTION BUT I WAS
JUST THINKING WALTER ABOUT WHAT
YOU WERE SAYING ABOUT THE ROLE
OF CSR AND GRANT REVIEW AND
MAYBE THESE LESS SPECIALIZED
REVIEWER GROUPS FOR THINGS LIKE
HEAL AND I KNOW ALSO IT SEEMS AN
EMPHASIS MORE ON GRANT
MECHANISMS AND YOU KNOW THIS HAS
BEEN VERY DRIVEN BY THE KINDS OF
STRATEGIC PLANNING THAT ROB WILL
BE TALKING ABOUT AND CONCEPTS
RELATED TO THAT AND IS THERE ANY
-- ARE THERE ANY UPDATES ABOUT
HOW FEASIBLE SOME OF THAT IS IN
THE CURRENT ENVIRONMENT?
>> YEAH, I THINK WILSON CAN
COMMENT, TOO, BUT WHAT WE
USUALLY DO IS WE PUT OUT A NOFO,
NOTICE OF FUNDING OPPORTUNITY
AND THAT TELLS THE COMMUNITY
WHAT WE'RE LOOK FOR IN TERMS OF
THE TYPE OF SCIENCE AND YOU KNOW
THE -- SOMETIMES THE MECHANISM
BY WHICH WE'RE LOOKING TO HAVE
THAT SCIENCE DONE, YOU KNOW,
CLINICAL TRIALS, THERAPY
DEVELOPMENT OFTEN PHASE TRIALS,
PHASED AND THAT'S GOING TO BE
HARDER TO DO.
PRETTY CLEAR THAT THAT THE
EMPHASIS NOW IS TO DECREASE THE
NUMBER OF NOFOs AND THEY'RE
ALSO GETTING APPROVAL AT
MULTIPLE LEVELS, SO THAT IS
GOING TO STYMIE US AND CERTAINLY
SLOW US DOWN IN TERMS OF MOVING
THESE THINGS FORWARD.
I THINK THAT'S -- THAT'S THE
MESSAGE WE'VE BEEN GETTING.
>> THANKS.
ULTIMATE GOAL MATERIALLY THE
HOPE THAT THIS WILL BE MORE
EFFICIENT IN THE LONG RUN BUT
THE PROOF WILL BE IN THE PUDDING
AS THEY SAY.
SO I ENCOURAGE YOU ALL TO KEEP
AN EYE ON THIS OVER THE NEXT
YEAR OR 2 BECAUSE IF IT'S THAT
LONG A LAG TIME TO SEE THESE
BEING IMPLEMENTED BUT NIDA IN
PARTICULAR HAS HAD A LARGE
NUMBER OF NOTICES OF FUNDING
OPPORTUNITY OR WHAT MANY OF US
CALL RFAs AND WE'RE NOW QUITE
LIMITED IN HOW MANY WE WILL BE
PUTTING OUT THIS YEAR AND IN
FUTURE YEARS SO WE WILL BE
ADJUSTING AND USING THE WEB TO
HIGHLIGHT PRIORITY AREAS AND
ENCOURAGING YOU DR. DEBAR AND
OTHERS TO KEEP AN EYE OUT FOR
WHAT WE'RE HIGHLIGHTING AS
PRIORITY AREAS AND THEN USING
THE STANDARD GRANT MECHANISMS TO
ADDRESS SOME OF THOSE PRIORITY
AREAS.
>> RIGHT.
EXACTLY RIGHT.
THANKS, WILSON, YEAH.
>> WILL THOSE COME OUT AS
PROGRAM ANNOUNCE WANTS?
>> NO, THEY WILL BE -- STAY
TUNED.
WE DON'T HAVE THE FULL PROCESS
FULLY IMPLEMENTED BUT THE ROUGH
IDEA IS THAT THE WEBSITES WILL
HAVE A PLACE TO INCLUDE PRIORITY
AREAS, SO THE ONLINE VERSION OF
SORT OF THE HIGHLIGHTS AND
PROGRAM ANNOUNCEMENTS BUT IN
OTHER WORDS WE WILL FIND WAYS TO
COMMUNICATE TO YOU WHAT THE
PRIORITIES ARE BUT IT MAY MEAN
THERE'S A NEW PLACE YOU LOOK FOR
THEM.
>> GOT IT.
THANKS.
>> AND THESE ADVISORY GROUPS ARE
A WONDERFUL PLACE TO DISCUSS
THIS BECAUSE FRANKLY ONCE WE
START THIS IF YOU ALL AREN'T
AWARE OF, THAT MEANS WE HAVE A
LOT MORE COMMUNICATION TO DO.
>> JUST A QUICK QUESTION, IRENE,
ARE THE PROGRAM DIRECTORS STILL
AROUND, HAVE ANY BEEN ALSO ASKED
TO LEAVE?
>> I WAS GOING TO SAY A NUMBER
OF PROGRAM DIRECTORS TOOK THE
PACKAGES FOR EARLY RETIREMENT.
>> IS IT POSSIBLE TO FIND OUT
WHO THAT IS BECAUSE IF WE HAVE
TO REACH OUT AND YOU DON'T GET
AN ANSWER, YOU DON'T KNOW WHY.
>> WELL IF YOU DON'T GET AN
ANSWER, YEAH, JUST E-MAIL ME.
>> OKAY, THANK YOU.
THANK YOU.
>> NOW GAIL, CAN YOU TALK, CAN
YOU UNMUTE?
GAIL IS --
>> CAN YOU HEAR ME NOW?
I DON'T KNOW IF I CAN GET ON
CAMERA, OH, GOOD, THANK YOU.
HI.
I JUST WANTED A COUPLE COMMENTS
SO SOME THINGS ARE WORKING IN
THE CTN, I WANT YOU TO KNOW WE
GO GET OUR NOTICE OF ARK WARDS
FOR OUR CONTINUING APPLICATION
SO I'M VERY EXCITED ABOUT, I
JUST WANTED TO KNOW THERE ARE
THINGS COMING OUT AND THE ANSWER
THOSE QUESTIONS THAT I HAVE
GOTTEN FROM A VETERINARY
COMMUNITY OF DIFFERENT
INVESTIGATORS WHERE THINGS ARE
KIND OF IN LIMBO BUT I HAVE
REACHED OUT TO THE DIRECTORS OF
THOSE PARTICULAR AREAS.
LUCKILY I KNOW WHERE THEY ARE
BECAUSE I'VE BEEN ASSOCIATE WIDE
YOU ALL AND THEY HAVE BEEN VERY
RESPONSIVE SO CAN YOU ALWAYS GO
OFF AND SAY HELP ME OUT TO HELP
THIS INVESTIGATOR.
THE OTHER COMMENT I WANTED TO
MAKE IT THAT WE ARE SEEING A
NICE DECELERATION ON OVERDOSE
DUE TO A LOT OF WORK THAT
EVERYONE'S DOING.
WE WANT TO MAKE SURE THAT THE
NARCAIN IS GETTING OUT THERE BUT
I ALSO WANT TO MAKE SURE WE
COMMENT THAT THESE ARE NOT
ACROSS THE BOARD, THAT WE HAVE
FOUND GEOGRAPHICAL ISSUES, BEING
THAT LESS IMPROVEMENTS IN THE
WEST, LESS IMPROVEMENTS FOR
CERTAIN ETHNIC AND RACIAL GROUPS
SUCH AS BLACKS, LESS IMPROVEMENT
FOR AGE CERTAINLY OF PEOPLE WHO
ARE OLDER, SO, I JUST WANT TO
SAY WE HAVE A LOT OF WORK TO DO
AND WE NEED TO KEEP UP OUR
EFFORTS TO MAKE SURE THAT WE DO
CONTINUE THIS DECELERATION AND
IT'S NOT GOING TO PLATEAU OFF
AND WE ALSO KNOW IT'S DUE TO A
LOT OF OTHER THINGS WITH IT SO
THERE'S A LOT OF ATTENTION BEING
PAID TO POLYSUBSTANCE USE ALONG
WITH OPIOID.
THAT'S ALL I WANTED TO SAY.
KEEP UP THE GOOD WORK.
>> THANK YOU GAIL,IME VERY
PLEASED THAT YOUR GRANTS WENT
OUT AS EXPECTED THAT WAS A
RELIEF BOTH FOR YOU ALL BUT ALSO
FOR YOUR PROGRAM STAFF AND
LEADERSHIP.
I WOULD POINT OUT THAT SOME OF
THE ADVANCES, IN YOUR AREA,
WE'VE SEEN 9 IMPROVEMENTS IN
EMERGENCY DEPARTMENT STEPPING UP
TO ADDRESS OPIOID USE DISORDER
WITH STARTING MEDICATIONS ONSITE
AND AT THE TIME OF TREATMENT
WITHOUT JUST REFERRING PEOPLE TO
TREATMENT BUT STARTING IT.
BASED ON IMROWR SEMINOLE WORK 10
YEARS AGO THAT'S NOW REALLY
TAKEN HOLD IN SO MANY SIGHTS
AROUND THE COUNTRY AND
WITNESSING THAT ENGAGEMENT HAS
BEEN AWESOME.
>> GREAT.
AND A PLUG, TOO, IN THAT WE'RE
DOING IT PREHOSPITAL NOW.
WE HAVE BEEN WORKING DILIGENTLY
WITH SEVERAL SYSTEMS THROUGHOUT
THE COUNTRY AND PRESENTING, OUR
PRELIMINARY DATA THAT WE HAVE ON
PARAMEDICS, PREHOSPITAL
PERSONNEL WHO ARE WORKING WITH
PEOPLE WHO HAVE JUST OVERDOSED
AND BEEN REVERSED.
WE FOUND THAT WE COULD GIVE
BUPRENORPH THEN AND AS WELL AS
PEOPLE WHO ARE STOPPING THEM
BECAUSE THEY'RE IN WITHDRAWAL.
WE KNOW NOT EVERYONE WANTS TO
SEEK TREATMENT AND SO WE'RE
OPENING A WHOLE OTHER AVENUE.
SO WE'RE EXCITED ABOUT IT.
>> OKAY, WELL, THANKS A LOT
FOLKS AND LET'S NOW MOVE OVER TO
ANNA MAZZUCCO, WE WILL TALK TO
US ABOUT THE BACPAC PROGRAM,
SHE'S THE DEPUTY DIRECTOR AT
NIAMS WHERE SHE MANAGES THE
DAILY OPERATIONS FOR THE
EN--STRATEGIESITUTE, OVERSEES
NIAMS PARTICIPATION AND
PROJECTS.
SHE SERVED AS DEPUTY DIRECTOR OF
THE HEAL INITIATIVE BUILDING 1
AND SHE ALSO KRIEWBED TO THE NIH
INVESTIGATOR CO-OCCURRING
CONDITIONS OF COURSE THE LIFE
SPAN IN DOWN SYNDROME AND IN THE
RAD X PROGRAM AROWNT COVID-19
TESTING.
ANNA, YOU WANT TO TALK TO US
ABOUT THIS GREAT PROJECT BACPAC.
>> THANK YOU WALTER FOR THE KIND
INTRODUCTION, CAN YOU HEAR ME?
>> YEAH.
>> OKAY, THANK YOU SO MUCH AND I
DO MY BEST TO KEEP US ON TIME
ALTHOUGH LINDE TOLD ME WOO HAVE
ALET BIT OF ROOM TOWARD THE END
OF THE MEETING SO WE WILL TRY TO
HIT THE RIGHT BALANCE BUT THAT
WAS A VERY IMPORTANT DISCUSSION
WE WERE ALL HAVING SO THANK FUR
THAT.
SO I WILL JUMP RIGHT IN HERE AND
I WANTED TO SAY BRIEFLY THAT TO
BE HONEST WE WEREN'T ORIGINALLY
PLANNING TO PRESENT ON BACPAC
TODAY BUT SOME OF OUR COLLEAGUES
WHO ARE NO LONGER HERE, WERE
PLANNING TO PRESENT ON THE HEAL
DATA ECOSYSTEM AND SO WE'VE DONE
HERE WHAT I THINK IS HOPEFULLY
KIND OF A HELPFUL HYBRID
PRESENTATION, HIGHLIGHTING THE
ACCOMPLISHMENTS OF BACPAC BUT
ALSO IN HIGHLIGHTING SOME OF THE
INTERPLAY WITH THE HEAL DATA
ECOSYSTEM BECAUSE WE WANTED TO
EMPHASIZE THAT IMPORTANT WORK OF
OUR COLLEAGUES AND HOW OWL THE
HEAL PROGRAMS INCLUDING
BACPAC'RE LEVERAGING AND
BUILDING INTO THAT RESOURCE.
SO WITH THEY WILL TRY TO INCLUDE
HIGHLIGHTS ON THE HEAL DATA
ECOSYSTEM TOWARD THE END.
SO YOU CAN MOVE RIGHT ON AHEAD
LYNDIE INTO THE NEXT SLIDE.
BEFORE MENTIONING THE VISION FOR
BACPAC, I WANT TO MENTION ALSO
MA BACPAC IS REALLY ALSO
INSPIRED BY OUR STAKEHOLDER
BOARD, WHICH WE FEEL VERY
IMPORTANT TO MENTION THAT'S
COMPRISED OF PATIENTS,
PROVIDERS, PROFESSIONAL
SOCIETIES, GOVERNMENT SPONSORED
ORGANIZATION AND OTHERS WHO HAVE
GIVEN US IMPORTANT FEEDBACK ON
THIS PROGRAM OVER THE YEARS AND
I ALSO JUST WANTED TO MENTION MY
2 COLLEAGUES AT NIAMS,
DR. ARE--ADMINISTRATIVEIN
MARQUES WHO IS AT AN ALL DAY
MEETING AND DR. REBECCA LINDSAY
WHO HAS BEEN INVOLVED IN BACPAC
OVER THE YEARS AND YOU WILL HEAR
FROM REBECCA LATE THERAPY AND
AFTERNOON BUT I WILL PRESENT ON
BACPAC ON THEIR BEHALF.
SO THE BACPAC VISION TO PROVIDE
TARGETED AND MORE EFFECTIVE
TREATMENT FOR INDIVIDUALS WITH
CHRONIC LOW BACK PAIN AND REALLY
THE GOAL HERE IS TO DEVELOP A
STATE-OF-THE-ART MODEL FOR
CHRONIC LOWER BACK PAIN, AND TO
IDENTIFY FACTORS THAT PREDICTIVE
OF TREATMENT EFFECTIVENESS FOR
WELL DEFINED PATIENT
SUBPOPULATIONS AND LASTLY TO
DEVELOP AN AG GOR ITG
IMPEDIMENTS FOR MULTIMODAL
INTERVENTIONS FOR INDIVIDUALS
WITH DIFFERENT PHENOTYPES OF
CHRONIC LO BACK PAIN AND REALLY
THE IDEA THAT THOSE ALGORITHMS
COULD BE EXTENDED AND FUTURE
WORK FOR FURTHER TESTING AND
FURTHER IMPROVING OUR ABILITY TO
TREAT DIFFERENT PATIENT SUBTYPES
WITH CHRONIC LOWER BACK PAIN.
SO WITH THAT, ON THE NEXT SLIDE,
I WILL JUST TRY TO GO QUICKLY
BUT JUST HIGHLIGHT THE BACPAC
CONSORT JUMP WHOOPS AND --
CONSORTIUM AND THIS RESEARCH
TEAM THAT CONTRIBUTED TO THIS
EFFORT OVER THE LAST SEVERAL
YEARS AND I KNOW THAT ERIIN AND
REBECCA WOULD WANT ME TO
HIGHLIGHT JUST THE VERY
INTERDISCIPLINARY NATURE OF THIS
CONSORTIUM AND JUST THE CRUCIATE
UNIQUE
COLLABORATIONS WE'VE BEEN ABLE
TO BE A PART OF FOR THE LAST
SEVERAL YEARS WITH THIS GROUP.
AND I HOPE YOU WILL SEE THAT
REFLECTED IN OUR KIND OF MODEL
OF CHRONIC LOWER BACK PAIN AND
HOW THIS INTERDISCIPLINARY
APPROACH WE FELT WAS REALLY
IMPORTANT FOR THIS PROJECT.
SO ON THE NEXT SLIDE, I THINK I
WILL BRIEFLY SHOW OUR
DISTRIBUTION OF BACKPACK
RESEARCH SIGHTS ACROSS THE
UNITED STATES AND DIFFERENT
ASPECTS OF THE MECHANISTIC
RESEARCH CENTERS OR MRCs AS WE
REFER TO THEM LATER IN THE
PRESENTATION AND SITES OF OUR
CLINICAL TRIALS AS WELL, IN THE
NATIONAL INSTITUTES OF HEALTH,
OUR TECHNOLOGY RESEARCH SITES
AND ALSO OUR DATA INTEGRATION,
AND OPERATIONS MANAGEMENT CENTER
OR OUR DAC.
AND THEN ON THE NEXT SLIDE, I
WILL JUST TO HIGHLIGHT FOR YOU
TODAY AND HOPEFULLY WILL COME
THROUGH IN SOME OF THE DETAILS
OF THE PRESENTATION, THE SCALE
OF DATA GENERATED THROUGH BACK
PACK AND TO HOPEFULLY TIE-IN
LATER ON THE AVAILABILITY OF
THIS DATA IN OUR HEAL DATA
ECOSYSTEM AND HOW WE REALLY LOOK
FORWARD TO CONTINUED ANALYSIS OF
THIS DATA IN FUTURE WORK AND HOW
WE THINK THIS DATA WILL ALSO ADD
AND CAN BE UTILIZED BY OTHER
ACTIVITIES WITHIN HEAL INCLUDING
OTHER PAIN TYPES AND SO I'LL
JUST MENTION THAT WE FEEL THE
MAJOR SUCCESS IS THE HIGH
QUALITY OF THIS DATA AND THE
COMPREHENSIVE DATA THAT WE'RE
REALLY JUST BEGINNING TO SCRATCH
THE SURFACE OF.
ON THE NEXT SLIDE, I THINK WHAT
I WILL BRIEFLY MENTIONED BUT
JUST TO MAKE CLEAR THAT ONLY 1
OF 10 TREATMENTS FOR CHRONIC LOW
BACK PAIN ARE CURRENTLY
EFFECTIVE AND THAT WAS HIGHLIGHT
INDEED A LITERATURE REVIEW THAT
WAS PUBLISHED IN 301 TRIALS
INCLUDING PHARMACOLOGICAL AND
NONINTERVENTIONAL TREATMENTS AND
THESE HAVE INCONCLUSIVE EVIDENCE
AND THAT FUTURE WO, IS NEEDED
AND SO ON THE NEXT SLIDE, JUST
TO MAKE MORE EXPLICIT THAT
REALLY 1 OF THE ISSUES HERE IS
THAT ONLY A SMALL SUBSET OF
PATIENTS WITH CHRONIC LOWER BACK
PAIN RESPOND TO ANY GIVEN
TREATMENT.
SOME MAY FAIL TREATMENT AND SOME
TREATMENTS CAN MAKE PAIN
SIGNIFICANTLY WORSE AND SO THE
MAJOR CHALLENGE HERE IS TO
REALLY HAVE ENOUGH DATA OF THESE
DIFFERENT TREATMENT OPTIONS AND
BE ABLE TO HAVE BIOMARKERS OF
THOSE PATIENT POPULATIONS TO BE
ABLE TO DEEVOLVE THOSE
TREATMENTS AND UNDERSTAND WHICH
TREATMENTS WILL WORK AND WHICH
SUBTYPES AND PREDICT THAT IN
FUTURE STUDIES SO THAT WAS
REALLY THE GOAL OF BACPAC.
OT NEXT SLIDE, I WILL JUST
BRIEFLY MENTION 1 OF THOSE
TRIALS WHICH WAS LAUNCHED
THROUGH THE BACPAC CONSORTIUM,
THE PURPOSE OF WHICH WAS TO DO
EXACTLY THAT, TO IDENTIFY LINKS
BETWEEN BIOMARKERS AND THE
EFFECTIVENESS OF IN THIS CASE,
FOR ALREADY PROVEN KNOWN TO BE
EFFICACIOUS TREEPTS FOR LOWER
BACK PAIN AND THIS WAS DONE
THROUGH THE BEST TRIAL.
ON THE NEXT SLIDE, I WILL JUST
HIGHLIGHT, THERE WE GO, THANK
YOU LYNDIE, AS I SAID THESE 4
TREATMENTS, SO HERE YOU CAN SEE
THE SMART TRIAL DESIGN SCHEMATIC
AND THIS IS JUST TO MENTION
HERE, NOT AN EFFICACY TRIAL AS I
SAID BUT 4 INTERVENTIONS THAT
ARE KNOWN TO HAVE EFERACY AND I
WILL HIGHLIGHT THAT OVER A
THOUSAND PEOPLE WERE ENROLLED IN
THE BEST TRIAL AND OVER 800 WERE
RANDOMIZED TO 1 OF THESE 4
TREATMENT ARMS.
AND ON THE NEXT SLIDE SHOW A BIT
MORE DETAIL ABOUT THIS 2 STAGE
OF RANDOMIZATION DESIGN AND
WHAT'S, I THINK PRETTY REMARKAC
OF THIS TRIAL DESIGN IS THAT
THERE ARE ACTUALLY OVER 200
INTERVENTIONS IN TERMS OF
DIFFERENT OPTIONS FOR TREATMENT
BASED ON THIS 2 STAGE
RANDOMIZATION DESIGN AND JUST TO
MENTION THAT THE GOAL OF THAT
RANDOMIZATION SCHEME WAS REALLY
TO MIMIC REAL WORLD PRACTICES,
TO CONTINUE EITHER TO AN
EFFECTIVE TREATMENT OR TO
AUGMENT WITH A DIFFERENT
TREATMENT OR SWITCH TO A NEW
TREATMENT BASED ON THE FIRST
RESULTS OF THE FIRST STAGE, ALL
THE PARTICIPANTS ARE NOW OFF
PROTOCOL AND 617 PATIENTS HAVE
COMPLETED THE TRIAL AND SO WE
CAN THINK OF THIS AS TESTING 200
INTERVENTIONS BASED ON THIS
DESIGN.
AND SO ON THE NEXT SLIDE I WILL
BRIEFLY SHOW THE VISIT
ACTIVITIES.
THERE WAS BOTH THE OPTION FOR
LIGHT PHENOTYPING OR DEEP
PHENOTYPING, THE LIGHT BEING
REQUIRED AND THE DEEP
PHENOTYPING BEING OPTIONAL BUT
JUST TO NOTE HERE THAT EVEN WITH
LIGHT PHENOTYPING, A LARGE AND
VARIED AMOUNT OF INFORMATION WAS
COLLECTED ABOUT EACH PARTICIPANT
AND ON THE -- I SEE YOUR
QUESTION ALAN, I WILL PROBABLY
TRY TO ARE REABOUTECCA LINDSEY
MAY BE ABLE TO ADDRESS THAT IN
THE CHAT.
I AM COGNIZANT OF TIME SO I WILL
TRY TO MAKE SURE I MOVE QUICKLY.
BUT HERE AGAIN ARE THE TRIAL
SITES ACROSS THE U.S., AND THEN
ON THE NEXT SLIDE JUST TO
HIGHLIGHT ALSO AS WAS SHOWN
BRIEFLY IN THE DESIGN THAT THIS
TRIAL ALSO USES BIOMECHANIC
TECHNOLOGIES IN DIFFERENT
ASPECTS OF THE DESIGN AND THAT
INCLUDED 5 DEFINITE
BIOMECHANICAL TECHNOLOGY WHICH
WERE COMPARED IN THE BEST TRIAL.
THESE ENCLUEDED 2 TECHNOLOGIES
THAT TRACK WHOLE BODY MOVEMENT
AND 3 WEARABLE SENSORS AND THIS
PROVIDED AN ADDITIONAL
OPPORTUNITY TO EVALUATE WHAT
TYPES OF ASSESSMENTS MIGHT BE
MOST USEFUL IN EVALUATING
PATIENTS WITH CHRONIC LOWER BACK
PAIN.
SO WE WERE REALLY POLICED TO BE
ABLE TO INCORPORATE THIS AS PART
OF THE BEST DESEEN AND ON THE
NEXT SLIDE, JUST A BIT MORE
INFORMATION ABOUT THE PRIMARY
ANALYSIS WHICH IS CURRENTLY
ONGOING.
THE BEST TRIAL WAS FULLY
ENROLLED, THE DATA IS NOW LOCKED
AND BEING ANALYZED AND OUR PLAN
AT THIS POINT IS TO COMPLETE
WITH A PROJECT TEAM THE PRIMARY
OUTCOME ANALYSIS BI THIS SUMMER
AND SUBMIT PRIMARY OUTCOME
MANUSCRIPTS THIS FALL.
AND THE HOPE HERE IS REALLY TO
BE ABLE TO ADDRESS THESE 2
FUNDAMENTAL QUESTIONS: WHICH
PHENOTYPIC MARKERS BEST PREDICT
TREATMENT RESPONSE TO EACH
TREATMENTS IN THE TRIAL IN AND
BASED ON A GIVEN SET OF
PHENOTYPIC MARKERS CAN WE ASSIGN
A RECOMMENDED FIRST TREATMENT
AND A RECOMMENDED FOLLOW ON
TREATMENT IF NECESSARY?
AND WITH THAT WITH THE NEXT
SLIDE I WOULD LIKE TO SHOW 1
EXAMPLE OF SOME OF THE WAYS THAT
THIS DATA IS NOW BEING ANALYZED
AND WHAT WE LOOK FORWARD TO
CONTINUING TO ASSESS IN THE
FUTURE.
THIS IS AN EXAMPLE OF 1 OF THE
TYPES OF DATA THAT WAS COLLECTED
DURING THE STUDY ON IMMUNE SELL
QUANTIFICATION, THIS WAS DONE
VIA CYTOF, WHICH IS A FEW
TECHNOLOGY THAT USES MASS SPEC
FOR CELLS AND WHAT'S SHOWN HERE
IS THAT A HIGHER NUTRIFILL
PROPORTION WAS ASSOCIATE WIDE
GREATER PAIN AND REDUCED
PHYSICAL FUNCTION.
SO I'LL NOTE THAT BLOCKING
NUTRIFILL ACTIVITY HAS BEEN
LINKED TO THE TRANSITION FROM
ACUTE TO CHRONIC PAIN IN A
RECENT PUBLICATION, AND SO THIS
IS JUST 1 EXAMPLE OF SOME OF THE
ASSESSMENTS THAT WE LOOK FORWARD
TO DIGGING INTO FURTHER IN THIS
DATA SET, ON THE NEXT SLIDE, I
WOULD LIKE TO JUST PREVLY TALK
ABOUT 1 OF THE OTHER MRC STUDIES
THAT WAS ALSO DONE THROUGH
BACPAC.
THIS WAS ALSO ANOTHER CLINICAL
TRIAL LAUNCHED BY THE CONSORTIUM
TO TEST FOR INTERVENTIONS SHOWN
HERE KNOWN TO HAVE POSITIVE FOR
LOWER BACK PAIN AND THE 4 ISHT
VENTIONS ARE MEANT TO ARE VERIED
AND A CLASS OF INTERVENTIONS
WHICH ARE COMMONLY USED AND ON
THE NEXT SLIDE JUST A BIT OF THE
EARLY DATA ANALYSIS FROM THIS
STUDY SHOWING THAT THE
PERCENTAGE OF PARTICIPANTS WHO
SHOWED A STRONG BENEFIT, EACH OF
THE 4 TREATMENTS IN THE TRIAL
ALL 4 TREATMENTS HAD SOME
PARTICIPANTS WHO IMPROVED TO THE
PROPORTIONS WERE NOT THE SAME
AND EXCITINGLY A LOT OF EARLY
ANALYSIS, FOR EACH OF THE 4
TREATMENTS THE INVESTIGATORS CAN
FIND SIMPLE DEMOGRAPHICS OR
PEASHT REPORTED OUTCOMES THAT
WERE PREDICTIVE OF DIFFERENTIAL
RESPONSE SUGGESTING THIS WILL BE
POSSIBLE USING THIS DATA SET AND
ON THE NEXT 2 SLIDES I WOULD
BRIEFLY LIKE TO SHOW ADDITIONAL
WORK FROM THE CONSORTIUM.
THIS ANALYSIS SHOWN HERE IS NOT
ACTUALLY A CLINICAL TRIAL BUT A
PHENOTYPIC CLUSTERING THAT WAS
CONDUCTED ON SOME OF THE LARGE
DATA THAT WAS COLLECTED VIA THE
PARTICIPANT ANDS THIS WAS
ACTUALLY DONE BY THE UNIVERSITY
OF PITTSBURGH AND THE UCSF
TEAMS.
SO I WOULD LIKE TO HIGHLIGHT THE
CLUSTERING AND THIS ANALYSIS
SHOWED THAT DISTINCT CHRONIC
LOWER BACK PHENOTYPES CAN HELP
UNDERSTAND MECHANISMS AND ALSO
IMPROVE TAYLORING OF NEW OR
EXISTING TREATMENTS AND ON THE
NEXT SLIDE I WOULD LIKE TO SHOW
1 REALLY INTERESTING EXTENSION
OF THIS WORK WHICH ACTUALLY
SHOWS CROSS VALIDATION OF THIS
PATTERN THAT WAS DONE BY THE PIT
AND UCSF TEAMS AND THEY ARE
WORKING COLLABORATIVELY TO TEST
MODELS BY SWAPPING THE DATA
COHORTS AND THIS WAS MADE
POSSIBLE REALLY BY THE EXTENSIVE
HARMONIZATION OF THE DATA
COLLECTED THROUGHOUT THIS
CONSORTIUM WHICH WAS AN EARLY
FEATURE OF THE PROGRAM, SO ON
THE NEXT SLIDE, I WOULD LIKE TO
BRIEFLY SHOW, REALLY A SUMMARY
OF BACPAC'S WORK SO FAR BUILDING
TOWARDS THIS THEY--THE RETINAL
LOCATIONERAL MODEL WHICH EVOLVED
OVER THE TIME OF THE CONSORTIUM
AND BROUGHT TOGETHER DESPERATE
DISCIPLINES TO THINK ABOUT BACK
PAIN FROM DIFFERENT ASSPEBTS AND
JUST TO HIGHLIGHT AGAIN THAT THE
BACPAC CONSORTIUM HAD EXPERTISE
IN EVERIES PECT OF THIS MODEL
WHICH -- EVERY ASPECT OF THIS
MODEL WHICH LED TO COLLECTIVE
SHARING OF INFORMATION AND
UNDERSTANDING ASK WHAT WE'RE
REALLY EXCITED ABOUT IS THAT
SOME ASPECTS OF THIS MODEL CAN
INFORM OTHER TYPES OF PAIN AND
WE HOPE TO TEST THAT IN FUTURE
EXTENSIONS OF THIS WORK.
SO ON THE LAST FEW SLIDES I
WOULD LIKE TO HIGHLIGHT A FEW
OTHER EXTENSIONS ON THIS
THEY--THE RETINAL LOCATIONERAL
MODEL AND WHAT'S SHOWN HERE IS
OTHER EXCITING POSSIBILITIES FOR
THE APPLICATION OF AI AND LARGE
LANGUAGE MODELS TO REALLY EXTEND
THIS BACPAC THEY--THE RETINAL
LOCATIONERAL MODEL WHERE THIS
CAN BE ANALYZED BY VARIOUS AI
APPROACHES WHICH WILL FURTHER
HELP USE THE DATA TO REFINE THE
THEY--THE RETINAL LOCATIONERAL
MODEL SPECIFICALLY LARGE
LANGUAGE MODEL TOOLS FOR
SCOEVERRING CAUSAL ASSOCIATIONS
WITHIN THE DATA WHICH WILL HELP
REALLY BRING THE THEORETICAL
MODEL TO BEING MORE ACTIONABLE
AND TESTED IN FUTURE WORK AND
IMPORTANTLY, THE LARGE LANGUAGE
MODELS CAN ALSO BE USED TO
INCORPORATE PATIENT NARRATIVES
AND LIVED EXPERIENCE INTO THE
OVERALL PHENOTYPE.
SO ON THIS NEXT SLIDE JUST TO
HIGHLIGHT A LITTLE BIT MORE
ABOUT THE OTHER THEME WE WANT TO
EMPHASIZE IN TERMS OF
COLLABORATION, ACROSS HEAL, AND
THE IMPORTANCE OF THE HEAL DATA
ECOSYSTEM, IS REALLY JUST THIS
GRAPHIC SHOWN HERE OF ALL THE
DATA COLLECTED BY THE BACPAC
STUDIES AND THE EXAMPLES WE'VE
SHOWN IN THE PRESENTATION SO FAR
WE THINK DON'T EVEN BEGIN TO
TOUCH ON ALL THE DATA SETS THAT
ARE COLLECTED THROUGH BACPAC AND
IMPORTANTLY THAT THE DATA HAS
BEEN HARMONIZED TO THE MAXIMUM
EXTENT POSSIBLE SINCE THE
BEGINNING OF THE PROGRAM AND ALL
OF THIS DATA WILL BE AVAILABLE
ON THE HEAL DATA ECOSYSTEM WHICH
WE HOPE WILL YOU KNOW PROVIDE
ADDITIONAL OPPORTUNITIES FOR
SECONDARY DATA ANALYSIS FOR PAIN
RESEARCHERS AND SO ON THE NEXT
SLIDE, JUST AS 1 KIND OF FINAL
EXAMPLE OF THE DIVERSITY OF THIS
DATA AND I THINK THE STRENGTH OF
BEING ABLE TO DO CROSS
COMPARISONS, EXAMPLE SHOWN HERE
OF THE BIOSPECIMEN ANALYSIS
URNTD WAY FROM THE BACPAC AND
THE BEST TRIAL IN EACH OF THESE
DOMAINS ACROSS THE SITES.
YOU CAN SEE THE TYPE OF DATA
THAT'S BEEN COLLECTED INCLUDING
VARIOUS MULTIOMICS ANALYSIS THAT
HAVE BEEN PERFORMED TO DATE ON
THESE SAMPLES AND IMPORTANTLY WE
THINK THE WORK REALLY
DEMONSTRATES THE ABILITY TO
COMPARE ACROSS DATA SETS THROUGH
THE USE OF THE HARMONIZED DATA
WHICH WAS AN IMPORTANT PART OF
THE BACPAC APPROACH AND SO
LASTLY I WILL JUST SAY WITH A
NOD TO OUR ECOSYSTEMS COLLEAGUES
WHO LAID THE GROUND WORK FOR
THIS ECOSYSTEM STRUCTURE WHICH
WAS METABOLICALLY TO SPEED THE
INTEGRATION AND DATA COLLECTION
OF ACROSS HEAL AND ACCELERATE
THE SHARING OF DATA AND RESULTS
GENERATED BY HEAL TO RESEARCHERS
AND OTHERS BY THE COMMUNITY AND
ENABLE THIS DATA TO BE ANALYZED
AND CONFIGURED AND COMBINED AND
SO WE'RE EXCITED TO HAVE BACK
PACK, TO BE ABLE TO CONTINUE TO
CONTRIBUTE TO THAT RESEARCH
INFRASTRUCTURE AND SO WHAT I
WOULD LIKE TO LEAVE YOU WITH AND
JUST KIND OF OUR BROADER
THINKING ABOUT WHERE MANY OF
THESE ACTIVITIES MIGHT CONTINUE
TO WORK TOGETHER IN THE FUTURE
THAT WE FEEL BACPAC HAS REALLY
BEGUN TO LAY THE FOUNDATION FOR
THINKING AT A SYSTEMS LEVEL
ABOUT CHRONIC LOWER BACK PAIN
AND THAT WE ARE LOOKING FORWARD
TO IN THE FUTURE IN VARIOUS WAYS
CONTINUING TO SUPPORT
COMPREHENSIVE COMPARISON OF
PHENOTYPES ACROSS VARIOUS PAIN
CONDITIONS SO YOU WILL SEE OTHER
HEAL PROGRAMS OF NOTE HERE WHERE
THERE'S BEEN CONNECTIONS WITHIN
BACPAC AND WE HOPE TO CONTINUE
TO SUPPORT THAT INTERPLAY IN THE
FUTURE WITH A FOCUS ON REALLY
DEVELOPING MORE WHOLISTIC
MODELS, UNDERSTANDING INTERPLAY
AND CONNECTIONS BETWEEN LOWER
BACK PAIN, KNEE PAIN, TMJ,
INTEGRATING DATA AND RESEARCH
METHODOLOGY IT IS FROM THE
BACPAC COMMUNITY, THE REGIONAL
COMMUNITY, MY O FACIAL PAIN
COMMUNITY, ANOTHER HEAL PROGRAM
AND OTHERS AND I WILL LEAVE YOU
WITH 1 LAST LOOK INTO THE FUTURE
AND WHAT WE'RE HOPING TO MOVE
FORWARD, THE NEXT PHASE OF
BACPAC IS ENVISIONED AS
INTERACT, INTEGRATIVE PACK PAIN
LONGITUDINAL COHORT TEAMS WHICH
WE LOOK FORWARD TO EXPANDING OR
ENHANCING LONGITUDINAL DATA
COLLECTION AND ANALYSIS OF
EXISTING LARGE SCALE CHRONIC
PAIN COHORTS AND BUILDING ON THE
SUCCESS OF BACPAC, FORMING AN
INTERACTIVE COLLABORATIVE
NETWORK WHERE WE HOPE TO
CONTINUE TO INTEGRATE ACROSS
HEAL PROGRAM WHERE IS THERE MAY
BE BIOLOGICAL SHARED MECHANISMS
AND CONTINUE TO HAVE AN
INTEGRATED DATA APPROACH AS WELL
TO UNDERSCORE ALL OF THESE
EFFORTS.
SO WITH THAT I WILL TAKE ANY
QUESTIONS AND ALSO THANK MY
COLLEAGUE REBECCA LINDSAY WHO IS
HERE AND CAN ANSWER QUESTIONS AS
WELL.
AND I KNOW REBECCA ALREADY
ANSWERED SOME QUESTIONS IN THE
CHAT.
ALAN ARE YOU TRYING TO UNMUTE?
>> I'M ALWAYS TRYING TO UNMUTE.
>> THERE I HEAR YOU NOW.
>> BUT OKAY, SO THERE WAS SOME
EFFORT TO ANSWER THE QUESTION.
THAT'S GREAT.
THE REAL ISSUE AND IT'S SO KEY
AND OF COURSE JANE VALENTINE AND
I HAVE DISCUSSIONTHIS ALL THE
TIME IS WHETHER THERE'S A SENSE
FROM THE BACPAC FOLKS THAT IN
THE CASE OF BACK PAIN THAT THERE
IS A FOCUS OF INJURY IN THE BACK
SOMEWHERE THAT IF 1 COULD
IDENTIFY IT AND TREAT IT THAT 1
WOULD NOT NEED TO GO INTO THE
BRAIN AND THAT'S THE QUESTION
THAT I ALWAYS ASK BECAUSE I'M A
BIG BELIEVER I THINK AS YOU MAY
KNOW THAT I THINK IN MOST
CHRONIC PAIN CONDITIONS THERE IS
A PERIPHERAL DRIVER.
SO I'M CURIOUS TO KNOW WHETHER
THE BACK PACK FOLKS BELIEVE
THERE IS A SOURCE, THEY JUST
CAN'T IDENTIFY IT.
>> YEAH, I THINK I CERTAINLY
THINK THAT'S LIKELY TRUE, BUT
I'M GOING TO ASK REBECCA WHO'S
BEEN MORE DEEPLY INVOLVED WITH
THAT TEEM IF SHE WOULD LIKE TO
COMMENT ON THAT.
OBVIOUSLY VERY INTERESTING
QUESTION.
>> CAN YOU HEAR ME?
I THINK I PUT IN THE CHAT, I
BELIEVE THIS IS AN ISHT
DISCIPLINARY TEAM THAT
RECOGNIZES THERE IS A LOT OF
INPUT AND IS NOT NECESSARILY
ASCRIBING A SINGLE CAUSE
MECHANISM AND TRYING TO
UNDERSTAND THE INTERPLAY FROM
EVERYTHING SO I WOULD SAY IT'S
PART OF THE PROCESS.
>> THEY COULD BE A TARGET.
BUT IT IS INTERESTING THAT THERE
IS INCLUSION OF DULOXETINE BUT
IS GABBA PENTINE REGIMENIN NOT
PART OF THE EFFORT?
WHICH MADE ME THINK THAT THE
ADDER NERNLGIC COMPONENT HAD A
SPECIFIC REASON FOR GOING AFTER
IT?
>> SURE, GABBA PENTINE REGIMENIN
WAS NOT INVOLVED IN ANY OF THE
STUDIES I SHOWED BUT REBECCA I
DON'T KNOW IF THAT WAS ENCLUED
INDEED ANY OF THE OTHERS?
>> I DON'T KNOW IF THAT WAS A
SPECIFIC INCLUSION OR EXCLUSION
CRITERIA IN THE COHORT STUDIES
BUT I CAN FOLLOW UP.
>> THANK YOU.
>> SO I HAVE A QUESTION WHICH IS
WHAT PAIN MANAGEMENT SPESHTISTS
ARE OFTEN DOING TARGETED
PROCEDURES WHICH MAY RELATE TO
ALLAN'S QUESTION ABOUT IS THERE
A SPECIFIC LESION SOMEWHERE,
INJECTING STEROIDS, INJECTING
LOCAL ANESTHETIC, IMPLANTING
STIMULATORS, THIS SORT OF THING,
WHERE DOES THAT FIT IN?
>> SO AGAIN, I MEAN THERE'S
THESE LARGE COHORTS AND SOME OF
THAT DATA IS BEING CAPTURED SO
FOR EXAMPLE, PAST SURGERIES,
PAST INJECTIONS, SO, THAT'S SORT
OF SOME OF THE DATA THAT'S GOING
TO BE IMPORTANT TO ASSESS THE
ROLE IN THE PAIN MANAGEMENT.
>> YEAH, YEAH.
>> BUT THERE'S NOT SPECIFIC DATA
ON THAT RIGHT NOW WITHIN THE
CONSORTIUM IS WHAT I'M TRYING TO
SAY.
>> RIGHT, RIGHT.
>> IT'S A REALLY IMPORTANT
QUESTION IS OBVIOUSLY STEROIDS
ARE USED LOCAL ANESTHETICS ARE
USED AND THE LOCAL AREA OF
ASSUMPTION THAT THERE IS A
TARGET CAN YOU GO AFTER AND IN
MANY INSTANCES WILL BE EFFECTIVE
BUT OF COURSE TELL BE EFFECTIVE
FOR A SHORT PERIOD OF TIME AND
MAYBE NOT ABLE TO REPEAT IT, SO
THE REAL QUESTION IS, WHAT IS
THE -- WHAT DO YOU CONCLUDE FROM
THAT RESULT THAT THERE WAS A
RESPONSE BUT THAT YOU COULDN'T
REPEAT IT.
DID THE CNS BECOME THE DOMINANT
AND MAYBE EVEN INDEPENDENT
ELEMENT WHICH THE NOSI PLASTIC
VIEW WOULD ACCEPT OR ARE WE
MISSING SOMETHING?
>> MAYBE TO JUST ADD TO THE
DISCUSSION, COULD YOU GO BACK TO
THE LAST SLIDE YOU JUST HAD
BECAUSE THE EFFORTS TO BRING IN
THE EFFORTS OF MY O FACIAL AND
THE HOME JOINT EFFORT TO THE
POINT, WE'RE TRYING TO FIND OUT
PERIPHERAL MECHANISMS THAT
CONTRIBUTE TO PAIN AT LEAST
INITIALLY THAT MAY LEAD TO
NEUROPLASTICKITY IN THE BRAIN
BUT THIS SLIDE I THINK CAPTURES
THE INTEGRATIVE APPROACH THAT
THE PROGRAM IS PROPOSING MOVING
FORWARD, THAT INVOLVES BOTHER
55ERAL MECHANISMS AND THE
MYOFACIAL PAIN REJOIN BACPAC IN
GENERAL AS AN INTEGRATIVE
APPROACH TO LOOK FOR THOSE
TARGETS PERIPHERALLY, MUSK LO
SKELETAL MARKERS, ALL THIS WILL
THEN BE PART OF A WHOLISTIC
APPROACH, RIGHT?
INVOLVING PERIPHERY AND BRAIN
AND AND PHARMAICOLOGGIC AND
NONPHARMAICOLOGGIC TREATMENTS
MOVING FORWARD, SO THIS SLIDE
MAYBE HELPS CAPTURE WHERE THIS
PROGRAM IS GOING WITH ALL THE
VARIOUS ELEMENTS.
>> EXACTLY.
THANK YOU, DAVID.
>> THIS IS NOT A RHETORICAL
QUESTION BUT IS DRG STIMULATION
USED TO ANY GREAT EXTENT FOR
BACK PAIN.
>> NOT THAT I KNOW OF BUT IT'S
ACTUALLY STIMULATION OF THE
NERVE ROOTS THAT INFILL STRAIGHT
THE BONY PLATE THAT PEOPLE ARE
CLAIMING IS EFFECTIVE NOW.
>> OKAY, WELL I THINK WE SHOULD
KEEP MOVING.
>> WELL I WILL HAND IT BACK TO
AMY I THINK AND SHE WILL
INTRODUCE THE NEXT SPEAKER AND
HOPEFULLY I HAVEN'T STOLEN TOO
MUCH OF THEIR TIME.
THANK YOU VERY MUCH.
>> NO, NO, THANK YOU AMY THAT
WAS A HELPFUL OVERVIEW.
SO I'M REALLY DELIGHTED TO
INTRODUCE PRESENTERS FOR THE
HEAL RESEARCH ADDRESSINGNYONATAL
OPIOID WITHDRAWAL SYNDROME SO
THIS INCLUDING TONSE RAJU, AND
STEPHANIE ARCHER, TONSE IS
ANYONATOLOGYIST AND A PROGRAM
OFFICER FOR THE IDEA STATES
PEDIATRIC CLINICAL TRIALS, AND
HE ALSO WORKS ON THE ECHO
PROGRAM, SHE PREVIOUSLY SERVED
AS CHIEF OF PREGNANCY AND
PERINATOLOGY BRANCH AT NICHD AND
HE HAS BOOK 2 BOOKSOT SUBJECT.
STEPHANIE ARCHER IS THE PROGRAM
ANALYST AND PROGEC MANAGER ARE
THE EEUNICE KENNEDY SHRIVER
NATIONAL INTUITY FOR CHILD
HEALTH AND HUMAN DEVELOPMENT AND
ALSO THE PEDIATRIC CLINICAL
TRIALS PROGRAM.
SO WE LOOK FORWARD TO HEARING
FROM YOU BOTH AND THANK YOU SO
MUCH FOR COMING TOGETHER.
>> YEAH, THANK YOU VERY MUCH.
CAN YOU HEAR ME WELL, I SUPPOSE.
>> YEAH, IT'S LOW SO YOU COULD
TALK A LITTLE LOUDER.
>> LET ME INCREASE THE VOLUME
HERE.
MAYBE BETTER NOW?
>> BETTER.
>> OKAY, SO AS YOU SAY, NOW FOR
SOMETHING COMPLETELY DIFFERENT
THAN WHAT WE HAVE SO FAR.
SO HERE WE ARE ADDRESSING
NEONATAL OPIOID WITHDRAWAL
SYNDROME.
NEXT SLIDE.
WHAT I AM PLANNING TO DO IN THIS
TALK WILL BE TO PROVIDE A BRIEF
OUTLINE OF WHAT ISNYONATAL
OPIOID DRUG SYNDROME WITH DUE
APOLOGIES TO ALL THE EXPERTS
HERE AND THEN WHAT SORTS OF
STUDY SAYS WE HAVE, YOU KNOW
BEEN ABLE TO DO THUS FAR, THE
VERY FIRST 1 WAS CURRENT
EXPERIENCE, THAT IS TO LOOK AT
HOW PEOPLE ARE TREATING
CHILDREN, NEW BORN BABIES WHO
ARE WITHDRAWING FROM OPIOID USE
DURING PREGNANCY AND THEN 2
STUDIES FUNDED BY HEAL, THE
CURRENT EXPERIENCE STUDY WAS
FUNDED BY THE ECHO,
ENVIRONMENTAL CONSEQUENCES OF
HEALTH EEIVETS ON CHILDREN.
NEXT SLIDE.
SO THE ACT NOW TRIALS STANDS
FORNYONATAL OPIOID WITHDRAWAL
SYNDROME, AND IN THE BLUE THIS
IS THE COLLABORATOR STUDIES I
WANT TO EMPHASIZE, MULTIPLE
SITES COLLABORATED TO DEVELOP AT
LEAST TBO MAJOR STUDIES FOR
CHILDREN AND THE 1S ON THE
RIGHT, YOUR RIGHT SIDE AS
NEONATAL RESEARCH AND NICHD, WE
START INDEED 1986, CURRENTLY 15
SITES AND MOST ARE AND MANY ARE
REGISTERING LOW NEONATAL OPILOT
PROJECTIE SYNDROME.
THERE'S RED, ON THE OTHER SIDE,
THERE IS NO REASON FOR THE COLOR
OF THE STATES.
THE ISPC TN AND IT START INDEED
2016 AND THAT IS IN THE OFFICE
OF THE DIRECTOR, IN THE PROGRAM,
PROGRAM, IDSTPROGRAM, AND IN
THAT WE HAD 18 CLINICAL SCIENCE
THAT PARTICIPATED IN THE ACT NOW
TRIALS, AND MANY OF THESE SITES
HAVE RELATIVELY SPEAKS MUCH
HIGHER PREVALENCE OFNYONATAL
OPIOID WITHDRAWAL SYNDROME, NEXT
SLIDE.
YOU CAN SEE OVER THE TIME PERIOD
THERE'S TREMENDOUS INCREASE IN
THE USER OPIOID USER DURING
PREGNANCY.
IT USED TO BE 1 AND HALF TO 2 OR
1000 DELIVERY HOSPITAL
ADMINISTRATION, RELATIVELY LOW,
AND WENT ALL THE WAY UP TO THE
2014 DATA UP TO 6.5 WOMEN HAVE
AT LEAST REPORTED AND IN THE
NEXT SLIDE, I WILL SHOW YOU,
NEXT SLIDE, GONE EVEN FROM 2014,
TO 2017, IT WAS 14.6 PER 1000
DELIVERIES.
SO THE OPIOID USE AMONG WOMEN,
SO YOU MIGHT THINK IT IS NOT A
LARGE NUMBER BUT CONSIDERING
THERE ARE 3.8 MILLION WOMEN WHO
DELIVER EACH YEAR, BETWEEN
3.8 MILLION DELIVERIES ANNUALLY,
IT BECOMES OPIOID USE DISORDER
HERE, AND YOU CAN SEE IT'S
56,000.
LIKEWISE THE NUMBER OF CHILDREN
ADMITTED TO THE HOSPITAL BECAUSE
OF MATERNAL USE OF OPIOID DURING
PREGNANCIES AND THE CHILDREN
HAVE WITHDRAWAL SYNDROMES AND
THEY HAVE 7 PER 1000 INFANT
HOSPITALIZATIONS.
NEXT SLIDE.
AND FOR THOSE WHO MIGHT NOT
REMEMBER, ALL THE ASPECTS OF
THENYONATAL OPIOID USE DISDROAM,
IT IS A MULTIORGAN AFFECTING
SYNDROME, THE CHILDREN HAVE HIGH
PITCHED CRY, THEY ARE HYPER
IRRITABLE, THEY HAVE SEIZURES,
SLEEP DEPRIVED, SLEEP
FRAGMENTATION, YOU CAN TAKE
CARDIAC ISSUES, THEY HAVE
TACHYPNOEA, HYPERTENSION,
TACHYCARDIA, DIARRHEA, EXCESSIVE
WEIGHT LOSS, VOMITING, THEY
DON'T FEEL WELL, THERE'S
SWEATING, HYPOTHERMIA, HYPER
TONIA, SO SO MANY SYMPTOMS ARE
THERE AND THEY ARE REALLY
EXTREMELY DIFFICULT TO TAKE CARE
OF.
YOU CAN HEAR 1 CHILD IN 1 ROOM,
AND THE ENTIRE NURSELY YOU CAN
HEAR THEM CRYING AND VERY, VERY
DIFFICULT TO CONSOLE.
NEXT SLIDE.
SO INITIALLY BEFORE WE LAUNCH
ANY OF THE CLINICAL TRIALS WE
WANT TO SEE WHAT KIND OF
MANAGEMENT STRATEGIES ARE BEING
USED ACROSS THE COUNTRY, SO 1
STUDY WAS DONE, CURRENT
EXPERIENCE STUDY, OBJECTIVE WAS
TO SEE IT, BOTH MATERNAL AND
INFANT CHARACTERISTICS AND WHAT
SORT OF VARIATION IN THEIR
MANAGEMENT, AND THE STUDY HAS
BEEN PUBLISHED NOW, I WILL
PRESENT BRIEF RESULTS OF THOSE
STUDY.
NEXT SLIDE.
SO THERE ARE ISPTN FUNDED
STUDIES, THEY WERE BETWEEN
2016-2017, AND WE HAD 1377
INFANT-MOTHER DIADS AND WE HAD
THE STUDY HELP US LAUNCH 2
CLINICAL TRIALS THAT I WILL
DESCRIBE IN DETAIL.
NEXT SLIDE.
SO WHAT DID WE FIND?
THE LARGE SITE TO SITE
VARIATION, WHEN THE MOTHERS HAVE
A PRENATAL COUNSELING WAS DONE
AS FEW AS ONLY 2% OF THEM TO AS
MANY AS 76% OF THEM.
PRENATAL CARE, FOLLOW THEM AND
NEARLY A HUNDRED% OF THOSE IN
SOME OTHER SITES, SIMILARLY
MEDICATION ASSISTED TREATMENT
FOR THE MOTHER WAS VERY, VERY
LIKELY AND THOSE RECEIVING
PHARMAICOLOGGIC THERAPY OR
RECEIVING ANY OTHER MEDICATIONS,
AND ALL THE VARIABLES THAT WE'RE
LOOKING AT.
NEXT SLIDE.
SO THE CONCLUSION WAS THERE WERE
STRATEGIES THAT VARIED A LOT.
AND THEREFORE, RESULTS INDICATE
THAD MANY OTHERS WITH OPIOID USE
DISORDERS, NOW, MAYBE HERE IN
OPTIMAL CARE AND MYSTERY
THEREFORE HELPED US TO DESIGN 2
ACT NOW ISHT VENTION TRIALS.
THE FIRST 1 WAS CALLED EAT,
SLEEP, CONSOLE FORNYONATAL
WITHDRAWAL SYNDROME, IT WAS
RANDOMIZED CONTROL TRIALS WHERE
26 HOSPITALS WERE INVOLVED AND
18 STATES.
NEXT SLIDE.
AND BEHIND IT IS TYPICAL
MANAGEMENT OF A NEW BORN BABY
WHO HAS NOW SYNDROME, IS USING
THE SYSTEM TO SEE HOW SERIOUS
ARE THE SYMPTOMS AND THEN
DEPENDING ON SOME SITE, USE A
LARGE NUMBER OF SYMPTOMS AND
THEN THEY WILL TREAT THEM WITH
EITHER OPIOID OR SOMETIMES
PHENOBARBIT OLDER PEOPLE, OR
SOMETIMES THEY USE MORPHINE AND
SOMETIMES PHENOBARBIT OLDER
PEOPLE.
BUT 15 YEARS AGO THERE WAS A NEW
APPROACH THAT CAME IN INSTEAD OF
IMMEDIATELY GOING INTO
PHARMAICOLOGICAL THERAPY WHY
DON'T THEY USE A SIMPLER, A
HUMAN KIND OF TREATMENT, HELP
THEM TO EAT PROPERLY, HELP THE
BABIES TO SLEEP PROPERLY AND
CONSOLE THEM, SWADDLE THEM, ROCK
THEM, SO CARE TAKER ESPECIALLY
MOM AND NURSES CAN BE MORE IN
THIS SO IT'S CALLED EAT, SLEEP,
CONSOLE APPROACH AND THERE WAS
NOT ENOUGH EVIDENCE TO SUPPORT
WHETHER THAT IS BETTER THAN
PHARMAICOLOGICAL THERAPY, REALLY
DO MAKE ANY DIFFERENCE, SO THAT
IS WHY THE STUDY WAS LAUNCHED.
NEXT SLIDE.
AND HERE, THE STUDY DESIGN WAS A
RABD ORDER OF MICRONSIZE --
RANDOMIZED TRIAL, FROM USUAL
CARE TO EAT SLEEP AND CONSOLE
CARE, AND THE WHOLE PRACTICE OF
CHANGE TRAINED 5000 NURSES AND
LED BY 3 EARLY STAGE
INVESTIGATORS AND THE RESULTS
WERE PUBLISHED 2 YEARS AGO IN
THE NEW ENGLAND JOURNAL OF
MEDICINE AND IT WAS AN BRAGZAL
HIT WHETHER THE PAPER CAME OUT.
NEXT SLIDE.
THIS IS THE MAIN MEET OF THE
STUDY, AND WILL SEE THAT MEAN
TIME UNTIL THE INFANT WAS
RELEASED OR DISCHARGED IN THE
USUAL CAR, ABOUT 15 DAYS,
WHEREAS IN THE BABIES HAD EAT
AND SLEEP AND CONSOLE APPROACH,
FIRST AND ONLY 8 DAYS OF THIS,
SO THERE WAS ACTUALLY 6 TO 7
DAYS ABSOLUTE DIFFERENCE WHEN
THE CHILDREN WAS READY TO BE
DISCHARGED AND THE PERCENT WHO
RECEIVED PHARMAICOLOGGIC
THERAPY, YOU CAN SEE 52% IN THE
USUAL CAR AND 20% IN THE EAT,
SLEEP, CONSOLE.
SO IT'S SIGNIFICANT.
YOU WOULD EXPOSE THE BABIES TO
FAR FEWER PHARMAICOLOGICAL
INTERVENTION EMPLOY NEXT SLIDE.
AND THIS STUDY HAD A LOT OF
IMPACT AND IT IT'S SUMMARIZING
THE DATA I JUST MENTIONED HERE,
YOU CAN TALK ABOUT NEXT SLIDE,
THERE IT IS, WASHINGTON STATE,
FORMALLY RECOGNIZED THAT ESC,
EAT, SLEEP AND CONSOLE SHOULD BE
THE PRIMARY APPROACH FOR ALL
CHILDREN WHO ARE IN HOSPITALS
TAKING CARE OF CHILDREN WHO HAVE
THIS SYNDROME.
SO BEFORE THE PAPER WAS
PUBLISHED, BETWEEN 6 MONTHS,
STATE OF WASHINGTON ACCEPTED
THIS AS STANDARD OF CARE, SO
IT'S VERY, VERY INTERESTING FOR
US.
NEXT SLIDE.
AND THE BABIES ARE BEING
FOLLOWED, JUST ABOUT COMPLETE
NOW, AND THE FOLLOW UP VISITS
ARE BEING ANALYZED AND SHOULD BE
PUBLISHED WITHIN THE NEXT 6
MONTHS.
NEXT SLIDE.
THE NEXT TRIAL WE DID WAS ACT
NOW TRIAL AND THE BACKGROUND FOR
THAT IS IN SPITE OF LOTS OF
PEOPLE USING OUR FARM
KACCTICOLOGICAL THERAPY THERE IS
NO STANDARD AS TO HOW YOU SHOULD
WEAN THOSE CHILDREN FROM THOSE
THERAPIES.
MORPHIN OR METHON DONE BEING
USED BUT MOW FAST TO WEAN THEM,
WEAN THEM 1 HALFA AT A TIME, 10%
AT A TIME.
HOW QUICK IN WHAT ARE THE
MONITORS?
HOW DO WE HANDLE THAT.
NEXT SLIDE.
SO THIS WAS DEVELOPED THEREFORE
SO THAT WE WOULD HAVE 2
STRATEGIES, IN 1 GROUP WE HAD
THEM FAST, THE OTHER 1 WE WEAN
THEM SLOWLY AND DEPENDING UPON
MEANING RAPIDLY, DID NOT MAKE A
WHOLE LOT OF DRVES COMPARED TO
READING STORY, RAPID WEANING IS
BETTER BECAUSE IN EXPOSING THESE
BABIES TO SMALLER AMOUNT OF
PHARMAICOLOGICAL THERAPIES.
NEXT SLIDE.
SO THIS STUDY THEN, THIS JUST
COMPLETED SO I'M SUMMARIZING THE
RESULTS FROM THE STUDY THAT
SHOWED THE PRIMARY NUMBER OF
DAYS OF OPIOID TREATMENT,
MORPHINE OR METHADONE, INCLUDING
ESCALATION, FROM THE FIRST TO
THE CESSATION, THERE WAS A
PRIMARY OUTQUM AND THE IN THE
SECONDARY OUTCOME WE LOOK AT
DAYS OF OPIOID DEALING WITH
MORPHINE, THIS YEARS DAYS OF
OPIOID WITH METHADONE EXCEPT ALL
SECONDARY OUTCOMES.
NEXT SLIDE, THE IN THE MIDDLE OF
THE STUDY WE HAD TO RECALCULATE
THE SAMPLE SIZE BECAUSE IT
TURNED OUT AT ANY CASE, I WAS
JUST MAKING IT SIMPLE, THE IDEA
WAS TO SEE RAPID WEANING, AT
LEAST WE HAVE 2 FEWER DAYS OF
OPIOID THERAPY, NOW YOU MAY
STILL THINK 2 DAYS WAS THE BIG
DEAL BUT IF YOU TRANSLATE THAT
INTO THE ENTIRE NATION, IT WILL
BE A SIGNIFICANT COST SAVINGS IN
THE DAYS OF THERAPY.
IN ANY CASE BECAUSE OF THE
DIFFICULTY OF ENROLLING NUMBERS
THERE WAS A SAMPLE SIZE ON THE
BOTTOM LINE HERE, SLOW
RECRUITMENT AND RISK OPPORTUNITY
THIS WAS RECALIBRATED AND THEN
RECOMMENDED THAT ARE WE SHOULD
ENROLL 151 INFANTS PER EACH ARM,
FOR 80% POWER IN THE STUDY
.
NEXT SLIDE.
SO THIS IS THE INTERVENTION
DONE, ON THAT SIDE, YOU START
OFF AT HUNDRED PERCENT AND THEN
YOU DROP OFF 15% EVERY SECOND
LEVEL DEPENDING ON THE SYMPTOM
OF THE BABY, AND THEN IN THE
SLOW, YOU DROP BY 10% EACH DAY,
SO THAT'S THE DEVELOPED APPROACH
FOR INTERVENTION.
NEXT SLIDE.
ANYWAY, THIS IS A SLIDE I DO NOT
WANT TO SPEND MUCH TIME ON.
IF YOU LOOK AT ALL IT, WE HAD 19
-- I'M SORRY IN ALL THE MEANING
THERE WERE 91 BABIES, RAPID
WEANING IN 98 BABIES, WE HAD
FOLLOW UP ABOUT COMPARABLE
NUMBER ON THE GROUPS.
NEXT SLIDE.
SO THESE INFANTS ARE BEING
FOLLOWED UP AT 24 MONTHS WE WILL
FOLLOW AND WE WILL FINISH BY
NEXT YEAR.
NEXT SLIDE.
SO THE OUTCOME, ALLIANCE HAD
BEEN COMPLETED SINCE THEY HAD
NOT BEEN PUBLISHED, I'M NOT ABLE
TO SHARE WITH YOU THE RESULTS OF
THE WEANING TRIAL BUT WE EXPECT
THAT TO COME OUT IN 3-4 MONTHS.
SO RIGHT NOW THEY'RE BEING
REVIEWED BY 1 OF THE SUBJECTS.
THE NEXT SET OF SLIDES MY
COLLEAGUE FROM NICHD, STEPHANIE
ARCHER WILL BE PRESENTING.
>> THANK YOU TONSE, AND THANK
YOU EVERYBODY FOR LETTING US
PRESENT TODAY.
SO THE OUTCOME OF BABIES WITH
THE OPIOID EXPOSURE, IT'S CALLED
THE COHORT STUDY, NEXT SLIDE.
SO IT'S TRYING TO ANSWER THE
QUESTION, TO WHAT EXTEND IS IT
ASSOCIATE WIDE ATYPICAL
NEURODEVELOPMENTAL OUTCOMES AND
TO DO THAT, IT'S LOOKING AT A
SERIES OF TIME POINTS AFTER
BIRTH IN BOTH EXPOSED INFANTS
AND UNEXPOSED INFANTS THAT WERE
EXPOSED TO OPIOIDS WELL, A
FETUS, THEY'RE COLLECTING MRIs
AT 1 MONTH, 6 MONTH AND 24
MONTHS OF AGE AND DO BEING A
VARIETY OF ASSESSMENTS AT 1, 6,
12, AND 18, AND 24 MONTHS.
IT COMPLETED ENROLLMENT IN
DECEMBER OF 2023, WITH 237
INFANTS.
155 OF THEM WERE OPIOID EXPOSED
AND 82 OF THEM WERE UNEXPOSED
AND THE FOLLOW UP VISITINGILATES
ARE ONGOING PARTICULARLY FOR THE
18 AND 24 MONTH AGE VISITS.
NEXT SLIDE.
AND BECAUSE OF THAT WE DON'T
HAVE SET PAPERS OUT YET ON THE
RESULTS.
WE DO HAVE PRELIMINARY PAPERS
OUT ON SOME OF THE METHODS
INCLUDING A PERCEIVED STIGMA
OUTCOME MEASURE, IT IS DOING 2
DIFFERENT STUDIES, OPTIMIZE NOW
AND INFORM NOWS.
NEXT SLIDE.
AND LOOKING AT BASE LINE DATA
THIS WAS STARTED AFTER THE ESC
TRIAL RESULTS WERE OUT, SO WE
WANTED TO SEE WHAT CHANGED SIN
THEN SO WE KNOW WHAT THE TRIALS
WOULD HOPE TO DO WOULD CHANGE
FURTHER, CHANGE PRACTICE.
SO IT SHOWS LITTLE EVIDENCE
EXISTS ON THE BEST APPROACHES TO
IESHES DENTIFYING MONITORING AND
TREATING NOWS LIKE NONSE SAID,
IT WAS COLLECTING PATIENT LEVEL.
>> THE DATA COLLECTION IS
COMPLETED AND THE ANALYSIS ARE
ONGOING AND THE FIRST MANUSCRIPT
SHOULD BE PUBLISHED IN THE NEXT
3 MONTHS OR SO.
NEXT SLIDE.
SO THIS 1 IS LOOKING AT HOW TO
OPTIMIZE THE PHARMACOTHERAPYS
THAT THE BABIES RECEIVE IF THEY
NEED THEM AND WHAT IS THE BEST
METHOD OF PROVOIDING THAT
MEDICINE.
SO THE IDEA IS FOR NEW BORNING
THAT NEED MORE BUPRENORPH OR
METHADONE FOR NOWS CAN SYMPTOM
BASED DOSING WEANING REGIMEN
REDUCE THE NUMBER OF HOSPITAL
DAYS COMPARED TO A MORE
TRADITIONAL SCHEDULED TAPERING
APPROACH.
SO AT THE SCHEDULING APPROACH
THE INFANTS GET SCHEDULED
APPROACH AND IT DECREASES OVER
TIME UNTIL THEY NO LONGER NEED
THE MEDICATIONS.
THE -- WE WERE TESTING THE
SYMPTOM BASED APPROACH WHERE THE
INFANTS WOULD ONLY GET THE
MEDICINE IF THEY SHOWED SIGNS OF
NOWS THAT NEEDED TO BE TREATED.
THEY WERE DOING THIS IN A 2-STEP
PROCESS, 1 HAS A 5 MONTH
APPROACH BASED ON THE SCHEDULED
BASED APPROACH, HAD A 2 MONTH
WASH OUT PERIOD BETWEEN THE 2
AND THEN WE STARTED THE SYMPTOM
BASED APPROACH IN ALL OF THE
CENTERS, THE SECOND PERIOD OF
THE TRIAL WAS JUST COMPLETED
APRIL 11th, SO WE'RE HOPING TO
GET ALL OF THE HOSPITAL
DISCHARGE DATA SHORTLY AND DO
DATA CLEANING AND ANALYSIS FOR
THAT.
NEXT SLIDE.
AND THE CONCLUSIONS.
SO AS TONSE SAID THE ACT NOW
CURRENT EXPERIENCE SHOWED LARGE
PRACTICE VARIATIONS AND HELPED
PLAN ALL OF OUR OTHER TRIALS.
THE ESC SHOWED THAT BY USING
THIS EAT, SLEEP, AND CONSOLE,
CARRYING METHOD, THEY WERE ABLE
TO REDUCE THE NUMBER OF HOSPITAL
DAYS UNTIL THE INFANTS WERE
READY FOR DISCHARGE AND REDUCE
THE NEED FOR APILOT PROJECTOID
MEDICATIONS.
NEXT.
SO THE ACT NOW WEANING TRIAL,
THE ELBOW STUDY, INFORM NOW, AND
THE OPTIMIZED STUDY, HAVE
RESULTS.
AND OBOE, AND INFORM NOWS AND
OPTIMIZE NOWS, IS HELPING TO
ASSESS NEURODEVELOPMENT AMILLIO
OUTCOME AND HEALTH STATUS.
NEXT SLIDE.
AND WE CAN TAKE QUESTIONS.
>> DR. NUNES.
I'M CURIOUS, I'M SURE THERE'S A
REASON BUT BUPRENORPHINE IS NOT
BEING USED IN NEW BORN INFANTS
IS THAT OUT OF CONCERN FOR
PRECIPITATING WITHDRAWAL EVEN
WHEN THERE'S WITHDRAWAL SYMPTOMS
PRESENT.
IT'S SO EFFECTIVE IN ADULTS
BECAUSE IT SELF-TAPERS.
>> MAB I CAN ANSWER, SO
BUPRENORPHINE HAS NOT BEEN
SYSTEMATICALLY STUDY INDEED NEW
BORN BABIES.
I DON'T KNOW WHETHER THEY THE
FOLLOW UP HAS BEEN STUDIED FIRST
OF ALL IN NEW BORN BABIES, ALSO
VERY IMPORTANT, SOME OF THESE
BABIES ARE PREMOO TOUR WHICH
ADDS MORE COMPLEXITY FOR THAT,
SO, THEREFORE, WHAT HAS BEEN
ONLY USED MOST OF THE TIME, I
THINK NICH IS PLANNING A
BUPRENORPH TODAY AND STEPHANIE
CAN ANSWER THAT.
>> THE HELP FOR NOWS CONSORTIUM
WAS ORIGINALLY SET UP TO LOOK AT
THAT ALSO AND IF THEY END UP
WITH ANOTHER TIME LEFT, THEY
WILL BE TURNING TO THAT ONCE
THEY KNOW HOW TO DO THE
SCHEDULE, THE SCHEDULED VERSUS
SYMPTOM BASED TAPERING.
ONE OF THE ISSUES WITH THE
BUPRENORPHINE IS THAT IT TENDS
TO BE MIXED WITH ALCOHOL IN THE
FORMULATION AND THE FDA HAS BEEN
RETICENT IN ALLOWING THAT TO BE
USED IN TRIALS FOR BABIES.
SO WE ARE IN THE PROCESS OF THE
HELP FOR NOWS TEAM IS IF THE
PROCESS OF DEVELOPING A AN
ALCOHOL-FREE FORMULATION THAT
THEN WE COULD TEST.
IT IS USED IN SOME HOSPITALS BUT
IT HAS NOT BEEN ABLE TO BE USED
IN TRIALS YET.
>> RIGHT.
THANK YOU.
>> DR. JONES?
>> YOU'RE MUTED.
>> SHE CAN'T UNMUTE HERSELF.
>> I CAN'T, IT WON'T LET ME
NTHERE WE GO.
OKAY.
>> NOW THEY FIGURED OUT THE
TECHNOLOGY FIRST, I JUST WANT TO
ACKNOWLEDGE HOW INCREDIBLE
LOAMACYY IMPORTANT THESE SETS OF
STUDIES ARE AND HOW THE UNITED
STATES HAS BEEN SUCH A WORLD
LEADER IN BRINGING THIS TYPE OF
DESPERATELY NEEDED RESEARCH THAT
HAS REAL WORLD CLINICAL
APPLICATIONS AND IMPLICATIONS
FOR A LIFETIME, RIGHT?
BECAUSE WE'RE TALKING ABOUT
PREGNANT PATIENT ANDS THEIR
BABIES THAT ARE BEING TREATED
FOR THIS MEDICAL CONDITION THAT
IS TREATABLE AS YOU ALL ARE
SHOWING, SO FIRST I JUST WANT TO
UNDERSCORE HOW IMPORTANT THIS IS
AND TO THANK YOU FOR ALL OF THE
WORK THAT YOU HAVE BEEN DOING.
SECOND, I WANTED TO ASK A
QUESTION AND THAT IS ABOUT THE
FIRST STUDY THAT WAS SHOWN AND
IN THAT YOU NOTE THAD 5000
NURSES WERE TRAINED ON THE ESC
PROCEDURE, AND I WONDERED IF YOU
ALL LOOKED AT FOLLOW UP, HOW
MANY HOSPITALS CONTINUED WITH
ESC, AFTER THE STUDY WAS
COMPLETED AND THEN THE FOLLOW UP
TO THAT -- TO WHAT EXTENT DID
YOU SEE PUSH BACK FROM
THENYONATAL INFANT CARE UNITS
BECAUSE WHAT I'VE HEARD IN THE
RESEARCH IECH DONE AND TRAINING
I'VE DONE IS THAT SOMETIMES OUR
HOSPITALS DON'T WANT TO EMPLOY
OR UTILIZE ESC BECAUSE IT GETS
BABIES OUT OF THE HOSPITAL
FASTER, WHICH IS A COST SAVINGS
TO OUR SOCIETY, BUT YET THAT IS
HOW THE HOSPITALS ARE GENERATING
MONEY.
SO I WANTED TO HEAR YOUR
THOUGHTS AND PERSPECTIVES ON
THAT.
>> WELL, YOU HAVE VERY
INTERESTING QUESTION, ANSWER TO
THAT I CAN ONLY SPECULATE.
I'M ANYONATOLOGYIST BY TRAINING,
ALL MY CAREER, I TREATED NEW
BORN BABIES UNTIL I JOIN WITH
NIH, BEFORE THEY WAS PROFESSOR
OF PEDIATRICS ANDNYONATOLOGY,
YOU'RE RIGHT.
THE ESC REQUIRES TRAINING, THERE
IS NO DOUBT ABOUT THAT.
AND RIGHT NOW, THERE ARE SOME
DATA BEING DEVELOPED AND IT
LOOKS LIKE PROBABLY AT LEAST
50-60% OF THE HOSPITALS ARE
TRYING ESC, ALTHOUGH WE DON'T
HAVE ANY DIFFERENT DATA BECAUSE
SOMETIMES IT IS MUCH EASIER TO
PRESCRIBE MEDICATION THAN TO
SAY, WELL, YOU KNOW SPEND
SOMETIME AND BE PATIENT AND HOLD
THE BABY, ET CETERA.
WE ARE ALL QUICK ON WRITING THE
PRESCRIPTION RATHER THAN USING A
HUMAN APPROACH THAT TAKES MORE
TIME, MORE PATIENCE AND THAT
NEEDS LEADERSHIP IN THE UNIT.
THAT'S WHAT IS STRONGLY BEING
RECOMMENDED.
NOW THE HOSPITAL IS KIND OF A
MIXTURE IN THAT QUESTION.
IT IS TRUE THAT HOSPITALSED LIKE
TO KEEP THE BABIES LONGER BUT ON
THE OTHER HAND REMEMBER MOST OF
THESE CHILDREN WHO ARE WITH
WITHDRAWAL SYNDROME,
UNFORTUNATELY THEY DON'T HAVE
INSURANCE, THEY HAVE MEDICAID OR
BUT THEY DON'T HAVE COMMERCIAL
INSURANCE, THEY MAY NOT
NECESSARILY BE HIGH INCOME
COMMERCIAL INSURANCE PEOPLE, SO
THERE MAY NOT BE PAYING
PATIENTS, SO HOSPITALS REALLY
DON'T WANT TO KEEP SUCH PATIENTS
FOR LONGER PERIOD.
SO IT GOES BOTH WAYS WHETHER OR
NOT THEY ARE INTERESTED.
I THINK THE MOST DIFFICULT PART
IS THE TRAINING PART.
THAT IS WHERE THEY HAD TO --
THEY HAD TO BE SOMEONE ADON
VOCATING THIS TO MAKE SURE A FEW
PEOPLE ARE TRAINED AND IT
DOESN'T TAKE MUCH TIME, MUCH TO
TRAIN THE MOMS AND WE HAVE HAD
SOME FOLLOW UP INFORMATION,
THOSE BABIES WHO ARE ESC ARM,
THEY ARE HPV HEALTHIER IN THE
FIRST 2 YEARS.
RECENTLY WE JUST LOOKEDDA THE
DATA, THEY ARE NOT PUBLISHED YET
AND THE MOTHERS ARE HAPPIER AND
LOOKS LIKE THE BABIES AT 2 YEARS
EVEN THOUGH LESS OF THEM GOT THE
PHARMAICOLOGICAL THERAPY THEY
DID MUCH BETTER OVERALL.
I THINK WE HAD PUBLISHED THAT,
SO THAT'S WHY I CAN'T FORMALLY
ANNOUNCE THE RESULTS BUT THOSE
ARE ALL VERY, VERY HELPFUL IN
FURTHER ENHANCING ESC AT FIRST
APPROACH.
THANK YOU.
>> YEAH, I WOULD ALSO ADD THAT
WE DID HAVE SOME ISSUES
CONTINUING TO FIND METHODS THAT
WERE STILL USING THE FIN GANNA
METHODS BECAUSE THEY'RE TRYING
TO CHANGE OVER TO ESC, AND CAN
YOU BEGIN OUR STUDY AND CAN WE
TELL YOU TO WAIT UNTIL WE SWITCH
IT.
>> YEAH.
>> ANY OTHER QUESTIONS?
IF NOT I THINK WE CAN TURN IT
BACK TO AMY AND RACHEL.
>> I HAVE 1 QUICK QUESTION WHICH
IS A SORT OF DESIGN WONKY
QUESTION, BUT STEP WEDGE
DESIGNS, I LOVE THE DESIGN, I
THINK IT'S REALLY TERRIFIC FOR
MANY REASONS BUT IT'S BEEN
CRITICIZED THAT IF THERE IS SOME
SECULAR TREND THAT CREATES A
DISRUPTION IN THE OUTCOME THAT
THAT CAN BIAS THE TRIAL, DID YOU
GET ANY KIND OF CRITICISM FOR
THAT?
>> I HAD TO SHOW HOW -- THE WAY
WE DID, IT WAS RANDOMIZED, THE
SITES, SO THE WAY WE PICKED UP
ON THE SITES BEGIN WITH A
SPECIFIC DURATION OF THE USUAL
CARE FIRST.
ALL OF THE TRIALS, ALL OF THE
SITES BEGAN USUAL CARE, BECAUSE
WE DID NOT WANT CONTAMINATION,
WE DID NOT WANT SOME SITES TO
START WITH ESC AND THEN SWITCH
TO USUAL CARE BECAUSE THEY SAY I
LIKE ESC AND I DON'T WANT TO
SWITCH BACK TO THE USUAL CARE,
SO ALL SITES HAVE USUAL CARE AND
THEN VARYING DURATIONS, AND THEN
THERE ARE WAS A PERIOD FOR 8
WEEKS OR SOMETHING IN BETWEEN
WHERE WE ARE NOT ENROLLING THOSE
PATIENTS SO IT'S A WASH OUT
PERIOD.
AND THEN THERE WAS THE -- WE
INTRODUCE THE ESC CARE, SO IN
THAT SENSE, I THINK WE TRY TO
MAKE IT AS CLEAN AS POSSIBLE,
BUT YOUR POINTS ARE WELL TAKEN.
>> YEAH.
>> I THINK TOO IN A TRIAL LIKE
THAT WHERE IT'S MORE OF A
BEHAVIOR CHANGE, BUT IT'S --
THERE'S REALLY NO WAY TO
INDIVIDUALLY RANDOMIZE THE KIDS.
>> NO, NO.
I UNDERSTAND.
IT'S A GREAT, I WAS JUST CURIOUS
IF YOU HAD ENCOUNTERED THAT
CRITICISM?
I THINK IT'S GREAT.
THE CONCERN IS IF ANY EXTERNAL
THING HAPPENS WHERE SUDDENLY THE
OUTCOME OF INFANT SYSTEM VERY
DIFFERENT FOR SOME REASON THAT
WAS UNANTICIPATED THAT CAN BIAS
THE TRIALY DEPENDING ON WHERE IT
OCCURS.
BUT I THINK TO HAVE SOMETHING
LIKE THAT HAPPEN IS PRETTY
UNLIKELY AND IT'S SUCH A GREAT
DESIGN FOR MANY REASONS, EVERY
SITE GETS TRAIN INDEED THE NEW
INTERVENTION, SO, YOU DON'T HAVE
SITES THAT GET IT, DON'T GET
IT,.
>> RIGHT.
>> YEAH.
>> AND FROM THE CURRENT
EXPERIENCE WE COULD TELL THERE
WAS A LOT OF SITE VARIATIONS,
SO, HAVING TO MANAGE THAT AS
WELL AS OKAY, YOU CAN'T LOOK AT
1 SITE VERSUS ANOTHER WHEN THERE
WAS SO MUCH DIFFERENCE TO BEGIN
WITH.
>> AND IT SEEMED INTERESTING
THAT IN THE ESC TRIAL, SITE
EFFECTS WERE NOT BAD, VERY GOOD
FOR US, THAT AFTER CONTROL
SITES, IT WAS FOLLOWED IN ALL
SITES IT WAS VERY TELLING THAT
ESC WAS A PREFERRED WAY FOR
TREATING THESE BABIES.
>> AND WE ARE USING THAT STEP
WEDGE APPROACH FOR THE OPTIMIZE
NOW STUDY WITH THE 2 DIFFERENT
PERIODS AS WELL.
AGAIN, IT'S MORE OF A BEHAVIOR
THING YOU KNOW FOR THE
HEALTHCARE TEAM TO BE DOING.
>> OKAY, WELL, THANK YOU BOTH
VERY, VERY MUCH AND WE
APPRECIATE THAT AND WE
APPRECIATE ALL THE QUESTIONS AND
THE VERY PRODUCTIVE DISCUSSIONS
WE HAVE HAD TODAY.
THIS BRINGS US TO THE END OF THE
OPEN SESSION OF THE DISCIPLINARY
WORKING GROUP.
SO THANKS TO EVERYBODY WHO HAS
JOINED US, THROUGH THE
VIDEOCAST.
WE WILL NOW TAKE A BREAK, I
THINK WE WILL TAKE A 15 MINUTE
BREAK WHICH WILL TAKE US TO
4:00.
AND THEN, WE WILL BEGIN THE
CLOSED SESSION PORTION OF █THE
MEETING, SO THANK YOU ALL.
AND WE WILL NOW MOVE TO A BREAK.
>> VIDEOCAST CAN YOU CONFIRM
WE'RE DISCONNECTED INCONNECTED?