I'M HAPPY TO CALL INTO ORDER THE
OPEN SESSION OF OUR 79th
MEETING OF THE NATIONAL ADVISORY
COUNCIL FOR COMPLEMENTARY AND
INTEGRATIVE HEALTH.
I WANT TO NOTE FOR THE RECORD
THIS MEETING IS BEING HELD
VIRTUALLY FOR ALL PARTICIPANTS,
INCLUDING NIH STAFF, COUNCIL
MEMBERS, AND THE PUBLIC.
THENLS R. HENCE THERE IS NO
IN-PERSON ATTENDANCE FOR THIS
MEETING.
I'M PARTAP KHALSA, EXECUTIVE
SECRETARY FOR THIS COUNCIL, I'M
DESIGNATED FEDERAL OFFICIAL FOR
THIS MEETING OF THE COUNCIL.
THIS MEETING IS BEING VIDEOCAST
LIVE BY THE NIH VIDEOCAST
SERVICE TO ANYONE WHO WISHES TO
ATTEND OUR -- TO LISTEN TO THIS
MEETING AND SEE IT.
SO, EVERYONE WHO IS -- ALL
COUNCIL MEMBERS WERE ON BY ZOOM
CALL, EVERYONE ELSE IN THE WORLD
CAN SEE YOUR ZOOM FEED RIGHT
NOW.
SO KEEP A SMILE ON YOUR FACE
PLEASE.
THIS IS REQUIRED BY TITLE 42 OF
THE U.S. CODE OF LAWS GOVERNING
NIH AND NCCIH, SECTION 287 OF
TITLE 42, CONVENED IN ACCORDANCE
WITH THE FEDERAL ADVISORY
COMMITTEE ACT, PUBLIC LAW 92.463
CODIFIED IN TITLE 5 OF THE U.S.
CODE OF LAWS.
I NOTE THE CLOSED SESSION WAS
HELD EARLIER THIS MORNING,
CLOSED TO THE PUBLIC, IN
ACCORDANCE WITH THE GOVERNMENT
IN THE SUNSHINE ACT ACT, PUBLIC
LAW 94-409, CODIFIED IN TITLE 5
FOR FEDERAL AGENCIES, SECTION
552.
WE WILL ENDEAVOR TO FINISH THIS
AFTERNOON BY AROUND 4:30 P.M.
EASTERN TIME.
THE OPEN SESSION OF COUNCIL IS
OPEN TO THE GENERAL PUBLIC TO
ATTEND VIA THE -- AS PREVIOUSLY
MENTIONED, LIVE NIH VIDEOCAST,
AND THUS CAN AND MAY BE VIEWED
BY INDIVIDUALS ACROSS THE
COUNTRY AND THE WORLD.
I WANT TO NOTE FOR THE PUBLIC
WE'VE ALREADY DONE INTRODUCTIONS
OF ALL THE COUNCIL MEMBERS TO
THEMSELVES, AND THEIR ATTENDANCE
IS ALSO AVAILABLE BY FEDERAL
REGISTRY NOTICE.
THIS OPEN SESSION WILL INCLUDE
THE REMARKS BY MYSELF NOW AND A
REVIEW OF AND VOTE FOR THE
REQUIRED ANNUAL COUNCIL
OPERATING PROCEDURES.
ONCE WE CONCLUDE THAT
ADMINISTRATIVE DETAIL, WE'LL
HAVE A -- IT WILL BE FOLLOWED BY
NCCIH DIRECTOR'S REPORT TO
COUNCIL, PRESENTATION BY DR.
EDWARDS ON FUND OPPORTUNITY
ANNOUNCEMENTS FOR PAIN RESEARCH
THAT NCCIH IS LEADING OR
PARTICIPATING IN.
FOLLOWING THAT, WE WILL BREAK
FOR LUNCH, AND FOLLOWING LUNCH
WILL RECONVENE WITH A
PRESENTATION BY DR. CRISWELL ON
THE MISSION OF THE NATIONAL
INSTITUTE OF ARTHRITIS AND
MUSCULOSKELETAL AND SKIN
DISEASES, AND ITS PAIN RESEARCH
PORTFOLIO AND SHARED INTERESTS
WITH NCCIH.
THAT PRESENTATION WILL THEN BE
FOLLOWED BY ANOTHER PRESENTATION
BY DR. LANGEVIN RESTORING WHOLE
JOINT HEALTH, FOLLOWING THAT
REQUIRED TRIENNIAL REPORT ON
CLINICAL STUDIES AND
REPRESENTATION OF GENDER, RACE,
AND MINORITIES, PRESENTED BY DR.
ROBIN BOINEAU, AND A CONCEPT
CLEARANCE ON HIGH PRIORITY PAIN
RESEARCH.
COUNCIL MEMBERS RECEIVED A COPY
OF THE SEPTEMBER 2021 MEETING
MINUTES, VIA ELECTRONIC COUNCIL
BOOK.
I LIKE TO FINAL MIZE MINUTES, TO
SEE WHETHER THERE ARE
CORRECTIONS TO THE FINAL COUNCIL
MEETING MINUTES.
IF ANYONE HAS A CORRECTION,
PLEASE LET ME KNOW NOW BY
RAISING YOUR HAND AND WE'LL
ENTER THAT.
I WANT TO ASK FOR APPROVAL OF
THE MINUTES.
>> SO MOVED.
>> AND A SECOND.
>> SECOND.
>> ANY FINAL QUESTIONS OR
COMMENTS OR DISCUSSION ABOUT THE
APPROVAL OF THE MEETING MINUTES?
SEEING NO HANDS RAISED OR
HEARING QUESTIONS, WE'LL GO
AHEAD FOR A VOTE BY COUNCIL.
YOU'LL SEE ON YOUR SCREENS A
POLL, ENABLING YOU TO VOTE, YES
MEANS YOU'RE APPROVING THE
SEPTEMBER 2021 COUNCIL MEETING
MINUTES, NO MEANS YOU'RE NOT, OR
YOU CAN ABSTAIN.
LET'S GIVE A FEW MORE SECONDS.
I SEE WE NOW HAVE UNANIMOUS
APPROVAL, ONE ABSTENTION.
SO MINUTES ARE APPROVED.
THANK YOU VERY MUCH.
I WANT TO NOTE THAT FUTURE
COUNCIL MEETING DATES ARE NOTED
ON THE AGENDA.
THE NEXT MEETING OF THIS
ADVISORY COUNCIL WILL BE ON
FRIDAY, MAY 13, 2022.
IT IS CURRENTLY SCHEDULED TO BE
HELD VIRTUALLY USING THE SAME
FORMAT THAT WE'RE DOING TODAY'S
MEETING ON.
IF THERE IS ANY CHANGE FROM THIS
VIRTUAL FORMAT WE'LL INFORM
COUNCIL MEMBERS AND THE PUBLIC,
ANNOUNCED AS POSSIBLE.
WE ALSO REQUEST COUNCIL MEMBERS
LET US KNOW IN ADVANCE, IF FOR
SOME REASON YOU'RE UNABLE TO
ATTEND ALL OR A PORTION OF THE
COUNCIL MEETING.
I'M NOW GOING TO GO AHEAD AND
SHARE MY SCREEN SO THAT WE CAN
DO THE REQUIRED REVIEW AND VOTE
ON APPROVAL OF THE COUNCIL
OPERATING PROCEDURES.
SO FOR THE PUBLIC, THESE ARE
LITERALLY THE OPERATING
PROCEDURES THAT THIS COUNCIL
OPERATES UNDER.
IT IS GOVERNED BY FEDERAL LAW,
REGULATION, AND POLICY.
WE'RE REQUIRED ANNUALLY TO DO
THIS TO HAVE A REVIEW AND THEN A
FORMAL VOTE BY COUNCIL ON THE
OPERATING PROCEDURES THEMSELVES.
SO, AS I JUST SAID, WE'RE
REQUIRED TO DO THIS.
IT'S PART OF THE CHARTER FOR
THIS ADVISORY COUNCIL, WHICH IS
POSTED ON THE NCCIH WEBSITE.
SO THE OPERATING PROCEDURES
COVER REALLY FOUR GENERAL AREAS.
THERE'S A SECTION ON REPORTS TO
COUNCIL.
AND THAT WILL LITERALLY BE THE
NEXT THING ONCE WE COMPLETE THIS
APPROVAL PROCESS FOR OUR
OPERATING PROCEDURES, WILL BE A
REPORT BY DR. LANGEVIN TALKING
TO COUNCIL ABOUT VARIOUS THINGS
OF IMPORTANCE.
THERE WAS A SECONDARY REVIEW OF
GRANT APPLICATIONS WHICH WE
ALREADY CONCLUDED IN THE CLOSED
SESSION EARLIER THIS MORNING.
IT COVERS CONCEPT CLEARANCES FOR
RESEARCH INITIATIVES.
ALSO COVERS ANY ADJUDICATION OF
APPEALS BY APPLICANT
ORGANIZATIONS OF THEIR
SCIENTIFIC REVIEW.
OF THEIR GRANT APPLICATION.
AND TOPICS ON POLICIES AND
RESEARCH PRIORITIES AND I'LL
SPEAK ON THESE FIVE AREAS.
NCCIH WILL INFORM COUNCIL OF
CURRENT SCIENTIFIC, BUDGETARY OR
LEGISLATIVE ISSUES AND
SIGNIFICANT CHANGES TO NCCI
HICKS AND/OR NIH, THIS INCLUDES
PERSONNEL CHANGES, DR. LANGEVIN
WILL W ILL GO OVER THAT.
THERE ARE SIX AREAS THAT FALL IN
THE SECOND REVIEW APPLICATIONS,
GRANT APPLICATIONS HAVE NO
SPECIAL CONCERNS, THERE ARE
GRANTS THAT NEED SOME SORT OF
SPECIAL CONSIDERATION, THERE ARE
VARIOUS OPTIONS THAT ARE
AVAILABLE TO COUNCIL, THERE ARE
ALSO ADMINISTRATIVE DECISIONS
AND ACTIONS THAT STAFF CAN TAKE
SUBSEQUENT TO A GIVEN COUNCIL
MEETING, THIS INCLUDES AS WELL
THE EXPEDITED EN BLOC
CONCURRENCE PROCESS AND
EXCEPTIONAL SITUATIONS.
I'LL TALK ABOUT THESE SIX AREAS.
GRANT APPLICATIONS SUBMITTED TO
NCCIH WITH NO SPECIAL CONCERNS,
THEY MAY BE IMPROVED BY WHAT WE
CALL EN BLOC PROCESS, LITERALLY
THAT MEANS ALL TOGETHER.
THESE APPLICATIONS MUST BE
RELEVANT TO MISSION OF THE
NCCIH, CANNOT HAVE CONCERNS
RELEVANT TO HUMAN PARTICIPANTS,
ANIMAL SUBJECTS, BIOHAZARDS OR
INCLUSION ISSUES, MUST BE
DOMESTIC ISSUES, MEANING
APPLICANT ORGANIZATION MUST BE
BASED IN THE UNITED STATES.
ANOTHER WAY OF SAYING THAT,
CAN'T BE FROM A FOREIGN
APPLICANT.
NO APPEALS PENDING.
IF THOSE ARE MET IT CAN GO
FORWARD FOR EN BLOC
CONSIDERATION.
SOME GRANTS NEED SPECIAL
CONSIDERATION BY COUNCIL.
THESE INCLUDE WHEN A GIVEN
APPLICATION THAT BE NOMINATED BY
STAFF OR COUNCIL FOR HIGH OR LOW
PROGRAM PRIORITY, OR GIVEN
APPLICATION DOES HAVE CONCERNS
RELATED TO HUMAN SUBJECTS,
ANIMALS, BIOHAZARDS, OR THERE
ARE ISSUES REGARDING INCLUSION
OF WOMEN, CHILDREN, AND/OR
MINORITIES.
IF THE APPLICATION IS FOREIGN OR
IF THERE'S AN APPEALS SUBMITTED
BY THE APPLICANT ORGANIZATION.
ALL OF THESE ARE THINGS THAT
TRIGGER SPECIAL CONSIDERATION BY
COUNCIL.
FINALLY, THERE'S AN AREA CALLED
SPECIAL COUNCIL REVIEW FOR
APPLICATIONS FROM PRINCIPAL
INVESTIGATORS OR PROJECT
DIRECTORS WITH GREATER THAN $2
MILLION TOTAL COST OF SUPPORT.
I WANT TO NOTE FOR COUNCIL
BECAUSE THIS IS A CHANGE FROM
THE PRIOR COUNCIL YEARS
OPERATING PROCEDURES, AND THIS
IS A CHANGE THAT BEING
IMPLEMENTED ACTUALLY FEDERALLY
WIDE ACROSS ALL FEDERAL
AGENCIES, INCLUDING NIH.
PRIOR DESIGNATION USED TO BE
BASED ON DIRECT COST OF SUPPORT.
IT'S NOW BEEN CHANGED FOR A
VARIETY OF GOOD ADMINISTRATIVE
REASONS TO INTERNAL COSTS AND
WHICH NOW INCLUDES THE DIRECT
AND INDIRECT COSTS.
WHEN COUNCIL IS VOTING ON
APPLICATIONS THEY BASICALLY HAVE
SIX DIFFERENT OPTIONS THAT THEY
CAN TAKE.
THEY CAN CONCUR WITH THE
RECOMMENDATIONS AND ASSESSMENTS
OF SCIENTIFIC REVIEW GROUP, THIS
IS THE METHOD MOST APPLICATIONS
GO THROUGH.
AN APPLICATION MAY BE DOMINATED
AND VOTED ON FOR EITHER HIGH
PROGRAM PRIORITY, LOW PROGRAM
PRIORITY, OR CATCH-ALL CATEGORY
WHICH WE CALL OTHER.
HIGH PROGRAM PRIORITY MEANS
COUNCIL IS REPRESENT INDICATION
AN APPLICATION BE RAISED IN
CONSIDERATION OF FUNDING.
LOW PROGRAM PRIORITY IS THE
INVERSE.
IT'S LITERALLY BEING LOWERED IN
CONSIDERATION FOR FUNDING.
COUNCIL MAY DEFER A GIVEN
APPLICATION TO THE NEXT COUNCIL
REALM BECAUSE THEY NEED TO GET
ADDITIONAL INFORMATION BEFORE
THEY CAN FAIRLY CONSIDER IT.
THEY MAY DEFER THE APPLICATION
TO GO BACK FOR ESSENTIALLY A
RE-REVIEW BY SCIENTIFIC BOARD,
DELAYED.
COUNCIL CAN RECOMMEND CHANGES, A
REDUCTION, THEY CAN'T RECOMMEND
TO INCREASE SCOPE BUT CAN
RECOMMEND TO DECREASE THE SCOPE
AND/OR BUDGET OR THE DURATION OF
THE SUPPORT.
FINALLY COUNCIL HAS THE OPTION
TO MAKE A FORMAL DESIGNATION A
GIVEN APPLICATION IS NOT
RECOMMENDED.
THAT OPTION IS ESSENTIALLY --
FORBIDS INSTITUTE FROM MAKING
AWARD REGARDLESS OF ENTHUSIASM
THAT THE INSTITUTE MIGHT HAVE
FOR A GIVEN APPLICATION.
THERE ARE CERTAIN ADMINISTRATIVE
DECISIONS THAT STAFF MAY TAKE
SUBSEQUENT TO A COUNCIL ROUND
THAT DO NOT REQUIRE ANY COUNCIL
RECOMMENDATIONS.
THESE INCLUDE THE FOLLOWING FOUR
THINGS.
IF THERE'S A CHANGE OF PRINCIPAL
INVESTIGATOR, SO THE APPLICANT
ORGANIZATION FOR WHATEVER REASON
WANTS TO CHANGE THE PRINCIPAL
INVESTIGATOR, THEN STAFF HAVE
THE AUTHORITY TO REVIEW THAT
CHANGE, AS LONG AS THEY MAKE
SURE THE NEW PRINCIPAL
INVESTIGATOR HAS THE WHEREWITHAL
TO BE THE P.I. ON THIS STUDY,
STAFF CAN MAKE THAT
ADMINISTRATIVE CHANGE.
THE INVERSE OF THAT IS IF THE
PRINCIPAL INVESTIGATOR'S GOING
TO STAY BUT INSTITUTION IS GOING
TO BE CHANGES, TYPICALLY A CASE
WHEN THE PRINCIPAL INVESTIGATOR
MOVES FROM ONE INSTITUTION TO
THE NEXT, AND WANTS TO TAKE THE
GRANT WITH THEM.
IF AN APPLICATION IS BEING
DEFERRED FOR RE-REVIEW AND
EVERYONE INVOLVED, THE
APPLICANT, PROGRAM STAFF, REVIEW
STAFF, ALL AGREE IT NEEDS TO BE
REREVIEWED FOR WHATEVER REASON
STAFF CAN MAKE THAT
RECOMMENDATION .
IN THAT CASE WE TAKE THE
APPLICATION OFF THE LIST OF
APPLICATIONS FOR COUNCIL AND PUT
IT ON NEXT SUBSEQUENT TO
RE-REVIEW.
STAFF HAVE AUTHORITY TO APPROVE
ADMINISTRATIVE SUPPLEMENTS MADE
TO AWARDED GRANTS.
WE HAVE OUR PROCESS, EXPEDITED
EN BLOC CONCURRENCE, THIS IS AS
PER NIH POLICY, INSTITUTES MAY
STREAMLINE THE EN BLOC
CONCURRENCE TO EXPEDITE FUNDING
ACTION BY THE CONCURRENCE
PROCESS.
ANY APPLICATIONS THAT ARE
ELIGIBLE FOR THE EXPEDITED EN
BLOC CONCURRENCE MUST MEET ALL
THE FOLLOWING CRITERIA.
FIRST, APPLICATIONS MUST HAVE
BEEN PEER REVIEWED THROUGH USUAL
SCIENTIFIC REVIEW PROCESS.
AND THE PEER REVIEW MUST ASSESS
THEM AS BEING SCIENTIFICALLY
MERITORIOUS WHICH TRANSLATES
INTO HAVING A CERTAIN SCORE FOR
CONSIDERATION.
THE APPLICATIONS FOR EXPEDITED
EN BLOC CANNOT BE COMING FROM AN
ORGANIZATION THAT'S BASED IN A
FOREIGN COUNTRY.
THEY CAN NOT HAVE CONCERNS
RAISED RELATED TO HUMAN, ANIMAL
SUBJECTS, AND SUCH APPLICATION
ALSO FOR EXPEDITED CONCURRENCE
ARE RELEVANT TO THE NCCIH
MISSION.
FOR APPLICATIONS ELIGIBLE, IT
OCCURS 6 OR 7 WEEKS PRIOR TO
REGULAR MEETING OF COUNCIL.
ALL REGULAR MEMBERS OF COUNCIL
MAY VOTE, APPLICATIONS MUST
RECEIVE AT LEAST TWO VOTES FOR
AND NO VOTES AGAINST THE
CONCURRENCE.
AND APPLICATIONS THAT THEN ARE
CONCURRED VIA THIS PROCESS WILL
BE ELIGIBLE FOR FUNDING
DECISIONS BY THE DIRECTOR, THIS
DOES NOT MEAN THEY WILL BE
AWARDED, IT JUST MEANS THEY ARE
NOW ELIGIBLE FOR FUNDING AND
SUBSEQUENT PROCESSING OF THOSE
APPLICATIONS.
WHEN ANY ACTIONS ARE TAKEN VIA
EXPEDITED EN BLOC CONCURRENCE
PROCESS, THEY WILL BE
COMMUNICATED TO COUNCIL DURING
REGULAR MEETING AS DONE EARLIER
TODAY IN CLOSED SESSION OF
COUNCIL.
THERE ARE EXCEPTIONAL SITUATIONS
THAT MAY OCCUR.
THE DIRECTOR HAS AUTHORITY TO
ACT UPON ANY EXTENUATING
CIRCUMSTANCES ASSOCIATED WITH
THOSE EXCEPTIONS, SITUATIONS.
AS SUCH, THE DIRECTOR MAY
CONSULT WITH THE SUBSET OF
COUNCIL MEMBERS TO DISCUSS THESE
EXCEPTIONAL SITUATIONS.
AND DECIDE TO TAKE ACTION.
ANY ACTIONS TAKEN OUTSIDE OF THE
REGULAR PROCESS OF COUNCIL
RELATED TO GRANT APPLICATIONS
WILL BE DOCUMENTED AND REPORTED
TO COUNCIL AT THE FULL MEETING
OF COUNCIL ON ITS NEXT REGULAR
MEETING.
COUNCIL HAS RESPONSIBILITY FOR
REVIEWING AND APPROVAL CONCEPTS
THAT COME ABOUT FOR RESEARCH
INITIATIVES.
CONCEPTS ORIGINATE FROM NIH
STAFF, SCIENTIFIC COMMUNITY,
CONSTITUENCY ORGANIZATIONS,
AND/OR CONGRESS ITSELF.
FOR THOSE CONCEPTS, STAFF WILL
PREPARE A SUMMARY OF THE CONCEPT
FOR REVIEW BY COUNCIL IN OPEN
SESSION, WE'LL HAVE SUCH A
CONCEPT THIS AFTERNOON FOR
COUNCIL'S ASSESSMENT AND
CONSIDERATION.
COUNCIL IN CONSIDERATION OF SUCH
CONCEPT, COUNCIL MAY RECOMMEND
APPROVAL, MODIFICATION, DEFERRAL
OR DISAPPROVAL OF THE CONCEPT.
AND IF COUNCIL DOES APPROVE IT
MAY LEAD TO ONE OR MORE FUNDING
OPPORTUNITY ANNOUNCEMENTS IN THE
FUTURE.
COUNCIL HAS A ROLE FOR BEING
ESSENTIALLY ADJUDICATING
APPEALS.
THERE ARE CERTAIN CRITERIA THAT
APPEAL MUST MEET.
APPEAL ESSENTIALLY IS A REQUEST
BY APPLICANT WHO DISAGREES WITH
THE ASSESSMENT OF THEIR GRANT
APPLICATION BY THE SCIENTIFIC
PEER REVIEW GROUP.
THAT IS, THEY GET A SUMMARY
STATEMENT THEY DON'T LIKE OR
DON'T AGREE WITH HOW THE -- WHAT
THE PEER REVIEW GROUP ASSESSED
IT AND WANT TO APPEAL THAT
ASSESSMENT.
THERE ARE CERTAIN CRITERIA THAT
STAFF USE TO ASCERTAIN WHETHER A
GIVEN APPEAL IS RELEVANT OR NOT
RELEVANT, OR CRITERIA OR
RELEVANT OR NOT.
RELEVANT CRITERIA WOULD BE
FACTUAL ERRORS IN THE SUMMARY
STATEMENT THAT MIGHT
SIGNIFICANTLY HAVE CHANGED THE
SCORE.
IF THERE'S EVIDENCE AGAIN IN THE
SUMMARY STATEMENT THAT THERE WAS
REVIEWER BIAS OR REVIEWERS HAD
CONFLICTS OF INTEREST OR THAT
THE PANEL LACKED THE NECESSARY
SCIENTIFIC EXPERTISE, ALL THESE
WOULD BE CONSIDER RELEVANT
CRITERIA FOR SUSTAINING APPEAL.
NOT RELEVANT WOULD BE ERRORS OF
OMISSION, AGAIN FROM THE SUMMARY
STATEMENT ITSELF, OR THAT THERE
ARE DIFFERENCES OF SCIENTIFIC
OPINION BETWEEN THE
INVESTIGATORS, PRINCIPAL
INVESTIGATOR OF A GIVEN
APPLICATION, AND SCIENTIFIC
REVIEW GROUP.
SO, IF A GIVEN APPEAL MEETS THE
ELIGIBILITY CRITERIAS, AND IF
THEN SUBSEQUENTLY PROGRAM AND
REVIEW STAFF THAT IS NIH PROGRAM
REVIEW STAFF AGREE THE APPEAL IS
JUSTIFIED, THAT IS IT DOES MEET
THE RELEVANT CRITERIA, THEN THE
GRANT IS DEFERRED FOR RE-REVIEW
BEFORE COUNCIL EVEN MEETS.
SO APPLICATION IS TAKEN OFF THE
COUNCIL LIST OF APPLICATIONS OR
THAT COUNCIL MEETING AND GETS
PUT ONTO THE NEXT MEETING OF
COUNCIL AS WELL AS UNDERGOING
RE-REVIEW BY SCIENTIFIC REVIEW.
IF STAFF DISAGREED ABOUT WHETHER
A GIVEN APPEAL IS MERITORIOUS,
WHETHER -- THE STAFF, THAT
APPLICATION OR APPEAL THEN GOES
TO THE CENTER'S APPEAL OFFICER
WHO ADJUDICATES.
IF THE APPEAL OFFICER SUPPORTS
THE APPEAL, THEN IT IS BROUGHT
TO COUNCIL DURING CLOSED SESSION
FOR COUNCIL'S CONSIDERATION AND
ADJUDICATION OF WHETHER A
RE-REVIEW WOULD BE APPROPRIATE.
IF THE APPEAL IS JUDGED BY STAFF
TO BE INELIGIBLE, THAT IS IT
DOES NOT MEET RELEVANT CRITERIA,
LETTER ONLY.
COUNCIL MAY SERVE AS RESOURCE TO
HELP DEVELOP, RECOMMEND, SET
POLICY AND RESEARCH PRIORITIES
FOR NCCIH.
WE DO THIS IN A MAJOR FASHION
WHEN WE HAVE THE PERIODIC
LOOKING ON SETTING UP A
STRATEGIC PLAN WHICH WE IN THIS
CASE COUNCIL APPROVED AND WE'VE
BEGUN IMPLEMENTING FROM LAST
YEAR.
AS SUCH, I'D LIKE TO GET A
MOTION FOR APPROVAL OF THE
COUNCIL OPERATING PROCEDURES.
>> SO MOVED.
>> I NEED TO GET A SECOND.
>> SECOND.
>> THANK YOU.
IS THERE ANY DISCUSSION BY ANY
COUNCIL MEMBERS ABOUT THE
OPERATING PROCEDURES?
HEARING NO QUESTIONS AND NOT
SEEING ANY RAISED HANDS, WE'LL
GO AHEAD AND GO FOR A VOTE.
ON OUR SCREENS, COUNCIL MEMBERS
WILL SEE A POLL THAT YOU CAN
VOTE ON.
A VOTE FOR YES MEANS YOU'RE
VOTING TO APPROVE OPERATING
PROCEDURES, NO MEANS YOU'RE NOT,
OR ABSTAINING.
AND I SEE A UNANIMOUS VOTE BY
COUNCIL MEMBERS FOR APPROVAL SO
THAT WILL BE ENTERED INTO THE
RECORD.
THANK YOU VERY MUCH.
I'LL STOP SHARING MY SCREEN.
THANK YOU VERY MUCH FOR THAT
APPROVAL.
I WANT TO ALSO NOTE TWO
CHANGES -- OR A CHANGE FROM THE
PRIOR COUNCIL ROUND FOR COUNCIL
MEETING DATES.
SPECIFICALLY, THERE IS A DATE ON
THE AGENDA FOR COUNCIL MEMBERS
FOR A MEETING VIRTUALLY IN
CLOSED SESSION ONLY IN AUGUST OF
2022, THIS YEAR.
YOU SHOULD HAVE RECEIVED THIS IN
THE COUNCIL AGENDA, YOU'LL SEE
THERE'S AN ADDED DATE FOR
COUNCIL MEMBERS TO MEET.
THIS IS IN ADDITION TO REGULAR
MEETING IN SEPTEMBER.
THIS IS FOR COUNCIL TO ASSESS
APPLICATIONS THAT ARE COMING IN
THAT NEED TO BE CONSIDERED FOR
FUNDING IN FY 22, WE HAVE A
NUMBER OF APPLICATIONS FOR
SPECIFIC INITIATIVES FROM NIH
THAT NEED TO GO FOR FUNDING
CONSIDERATION.
WE'LL PROVIDE YOU WITH MORE
INFORMATION BUT I WANT TO PUT
THIS ON YOUR CALENDARS.
AGAIN, CLOSED SESSION ONLY
MEETING OF COUNCIL, SO THE
MEETING WOULD TYPICALLY BE ON
THE ORDER OF AROUND AN HOUR TO
HOUR-AND-A-HALF.
WE'LL GIVE YOU THE SPECIFIC TIME
BUT PLEASE BE AWARE OF THAT.
THE LAST AGENDA ITEM FOR TODAY
IS THE OPEN -- FOR THE OPEN
SESSION OF COUNCIL IS THE PUBLIC
COMMENT SESSION.
BECAUSE THIS COUNCIL MEETING IS
BEING HELD VIRTUALLY, RATHER
THAN IN PERSON, IT'S NOT
POSSIBLE FOR MEMBERS OF THE
PUBLIC TO MAKE IN-PERSON
COMMENTS WHICH WE USED TO HAVE
AT ALL COUNCIL MEETINGS WHEN
MEETINGS WERE HELD IN PERSON.
AS SUCH, ANY MEMBER OF THE
PUBLIC WHO WISHES TO MAKE A
PUBLIC COMMENT TO OUR COUNCIL
MAY SEND ME YOUR WRITTEN
COMMENTS WITHIN 15 DAYS OF THE
CONCLUSION OF THIS MEETING.
THIS CAN BE DONE EITHER BY
E-MAIL OR HARD COPY LETTER.
IF YOU MAKE SUCH A COMMENT, YOUR
WRITTEN COMMENT SHOULD BE LESS
THAN 700 WORDS IN LENGTH, WHICH
IS CONSISTENT WITH ABOUT A
FIVE-MINUTE ORAL PRESENTATION,
WHAT HAS BEEN THE LONGSTANDING
POLICY FOR PUBLIC COMMENTS.
UPON RECEIPT, WRITTEN COMMENTS
WOULD BE ADDED TO THE ELECTRONIC
COUNCIL BOOK VIA THE COUNCIL
REVIEW SO COUNCIL MEMBERS WILL
BE ABLE TO VIEW COMMENTS
DIRECTLY.
AND THAT CONCLUDES MY OPENING
REMARKS.
DR. LANGEVIN, PLEASE, IT'S YOUR
FLOOR.
>> THANK YOU VERY MUCH.
IT'S MY GREAT PLEASURE NOW TO
BEGIN MY DIRECTOR'S REPORT.
LET ME SHARE MY SCREEN.
VOILA, CAN YOU SEE IT?
GREAT.
SO, IT'S MY GREAT PLEASURE TO
START BY WELCOMING THREE NEW
COUNCIL MEMBERS.
FIRST ONE IS DR. NADIA CECH,
UNIVERSITY OF NORTH CAROLINA
GREENS ROW, PROVIDES DYNAMIC
RESEARCH GROUP ENGAGED IN
DEVELOPING MASS SPECTROMETRY
METABOLOMICS TO SOLVE
CHALLENGING PROBLEMS IN NATURAL
PRODUCTS RESEARCH.
A MAJOR FOCUS OF THIS WORK IS
DEVELOPING NOVEL METHODOLOGIES
TO IDENTIFY COMBINATIONS OF
MOLECULES THAT INTERACT TO
ACHIEVE BIOLOGICAL EFFECTS,
SYNERGY OR ANTAGONISM.
A PRINCIPAL INVESTIGATOR FOR THE
NCCIH AND ODS-FUNDED CENTER FOR
HIGH CONTENT FUNCTIONAL
ANNOTATION OF NATURAL PRODUCTS
AND CO-DIRECTOR OF THE
ANALYTICAL CORE FOR ENTER OF
EXCELLENCE FOR NATURAL PRODUCTS
AND DRUG INTERACTION.
WELCOME.
NEXT NEW COUNCIL MEMBER IS LORI
KNUTSON, WHOLE HEALTH INSTITUTE.
PRIOR TO THIS, SHE WAS ASSOCIATE
VICE PRESIDENT FOR HEALTH AND
WELL-BEING AT DUKE UNIVERSITY
HEALTH SYSTEMS, EXECUTIVE
DIRECTOR OF DUKE INTEGRATIVE
MEDICINE.
SHE ALSO SERVED AS DIRECTOR OF
DUKE LEADERSHIP PROGRAMMING
HEALTH AND WELL-BEING.
SHE WAS FOUNDING EXECUTIVE
DIRECTOR OF THE GEORGE INSTITUTE
IN MINNEAPOLIS, AND AT THE TIME
THIS WAS NAMED AS LARGEST AND
MOST COMPREHENSIVE INTEGRATIVE
HEALTH PROGRAM IN THE UNITED
STATES.
SHE WAS INSTRUMENTAL IN
INFRASTRUCTURE AND DATABASE
DEVELOPMENT THAT LED TO
MULTI-MILLION NIH GRANT TO STUDY
INTEGRATIVE PAIN MANAGEMENT IN
CARE SETTINGS.
NEXT COUNCIL MEMBER IS DR. HELEN
LAVRETSKY, DEPARTMENT OF
INDUSTRY, UCLA, GERIATRIC
INTEGRATIVE PSYCHIATRIST,
RESEARCH PROGRAM IN GERIATRIC
DEPRESSION AND INTEGRATIVE
MENTAL HEALTH FUNDED BY NIMH,
PCORI, DEPARTMENT OF DEFENSE,
NCCIH.
USING MIND/BODY INTERVENTION
SUCH AS YOGA, MEDICATION, TAI
CHI, SHE'S DIRECTOR OF RESEARCH
FOR UCLA COLLABORATIVE AND
INTEGRATIVE MEDICINE, HER
CURRENT RESEARCH STUDIES INCLUDE
INVESTIGATIONS OF BIOMARKERS,
BIOMARKERS OF RESPONSES TO
MIND-BODY INTERVENTION FOR
GERIATRIC DEPRESSION, MILD
COGNITIVE IMPAIRMENT, USE OF TAI
CHI AND YOGA FOR TREATMENT AND
PREVENTION OF LATE LIFE MOOD AND
COGNITIVE DISORDERS.
SO WELCOME TO OUR NEW COUNCIL
MEMBERS.
I'LL NOW SHARE SOME NEWS.
THE FIRST BIG NEWS AT NIH IS
THAT DR. FRANCIS COLLINS HAS
STEPPED DOWN AS NIH DIRECTOR ON
SEPTEMBER 19, 2021, AFTER MORE
THAN 12 YEARS AT THE HELM.
HE WAS THE 16th DIRECTOR OF
THE NIH, THE ONLY DIRECTOR TO
SERVE MORE THAN ONE
ADMINISTRATION.
BEING APPROVED DIRECTOR, HE
SERVED -- EXCUSE ME, BEFORE
BEING APPROVED HE SERVED AS
DIRECTOR OF THE NATIONAL GENOME
RESEARCH INSTITUTE, AT NIH, FROM
1993 TO 2008.
AMONG DR. COLLINS' NUMEROUS
RECOGNITION OF ENORMOUS
CONTRIBUTION TO SCIENCE WERE
PRESIDENTIAL MEDAL OF FREEDOM,
NATIONAL MEDAL OF SCIENCE, ALSO
NOTABLY TEMPLETON PRIZE FOR
SCIENTIFIC AND SPIRITUAL
CURIOSITY.
WE'LL GREATLY MISS DR. COLLINS,
WHO REGULARLY ENTERTAINED US AT
NIH WITH HIS WONDERFUL MUSICAL
TALENT AND SENSE OF HUMOR AND IN
ADDITION TO HIS OUTSTANDING
SCIENTIFIC LEADERSHIP.
WE'RE VERY HAPPY, HOWEVER, VERY
FORTUNATE THAT DR. LARRY TABAK
IS TAKING THE HELM AS ACTING
DIRECTOR, PREVIOUSLY THE
PRINCIPAL DEPUTY DIRECTOR AT
NIH, SO WE KNOW THAT NIH IS IN
EXCELLENT HANDS DURING THIS
TRANSITION.
OTHER DEPARTURES, DR. MICHAEL
GOTTESMAN, AMAZINGLY HAS BEEN AT
NIH SINCE 1976.
HE'S BEEN PART OF THE NIH FAMILY
FOR OVER 45 YEARS.
MOST RECENTLY DR. GOTTESMAN
SERVED AS NIH DEPUTY DIRECTOR
FOR INTRAMURAL RESEARCH, AS WELL
AS CHIEF OF LABORATORY OF CELL
BIOLOGY.
ALSO RETIRING IS DR. BILL RILEY
WHO JOINED NIH IN 2005, AND HAS
HAD MANY IMPORTANT ROLES HERE.
HE SERVED AS DEPUTY DIRECTOR IN
DIVISION OF AIDS AND HEALTH
BEHAVIOR RESEARCH AT NATIONAL
INSTITUTE OF MENTAL HEALTH,
PROGRAM DIRECTOR OF NATIONAL
HEART, LUNG AND BLOOD INSTITUTE,
CHIEF OF SCIENCE AND RESEARCH
AND TECHNOLOGY BRANCH OF THE
NATIONAL CANCER INSTITUTE, AND
MOST RECENTLY HAS BEEN ASSOCIATE
DIRECTOR FOR BEHAVIORAL AND
SOCIAL SCIENCE RESEARCH AND
DIRECTOR OF OFFICE OF BEHAVIORAL
AND SOCIAL SCIENCE RESEARCH FOR
THE LAST SEVEN YEARS.
SO WE'VE HAD AT NCCIH MANY
OPPORTUNITIES TO COLLABORATE
WITH DR. RILEY.
I'M GOING TO MISS HIM.
NEXT IS DR. MARIA FREIRE,
PRESIDENT AND EXECUTIVE DIRECTOR
FOUNDATION FOR NATIONAL
INSTITUTE OF HEALTH, FNIH.
JUST RETIRED FROM TEN YEARS AT
THE HELM OF FNIH, 2012 TO 2021.
PRIOR TO FNIH SHE WAS PRESIDENT
OF THE LASKER FOUNDATION, AND
SHE ALSO IS A MEMBER OF THE
ACADEMY OF MEDICINE AND COUNCIL
OF FOREIGN RELATIONS.
FNIH IS REALLY INSTRUMENTAL IN
REALLY SORT OF HELPING CREATE
AND SUSTAIN PUBLIC/PRIVATE
PARTNERSHIPS, INCLUDING THE
VERY, VERY IMPORTANT
PARTNERSHIPS IN THE COVID
PANDEMIC IN CREATION OF ACTIV
INITIATIVE THAT SPEARHEADED THE
DEVELOPMENT OF MANY VACCINES,
THERAPEUTICS, ET CETERA.
ANOTHER BIT OF NEWS, AS MANY OF
YOU HAVE HEARD, THE NOBEL PRIZE
FOR MEDICINE THIS YEAR WENT TO
TWO INVESTIGATORS, DR.
PATAPOUTIAN AND DR. JULIUS, WHO
RECEIVED OF THE PRIZE FOR THEIR
WORK IDENTIFYING RECEPTORS THAT
ALLOWED THE BODY CELLS TO SENSE
TEMPERATURE AND TOUCH.
OF COURSE, SENSORY BIOLOGY IS
VERY IMPORTANT TO NCCIH RELATING
TO PAIN AND INTERSECTION OF MIND
AND BODY THERAPIES.
NOW FOR SOME STAFF UPDATES.
WE ARE ALL VERY SAD SHELLY
HEADLEY RETIRED THIS PAST
DECEMBER AFTER 35 YEARS OF
SERVICE IN GRANTS MANAGEMENT,
SEVERAL NIH INSTITUTES AND
CENTERS.
SHELLY JOINED 12 YEARS AGO, AND
OVER THE PAST SEVEN YEARS HAS
BEEN OUR CHIEF GRANTS MANAGEMENT
OFFICER, SO SHE'S THE ONE WHO
DISPATCHES THE GRANTS, LEADING A
DEDICATE AND HIGH PERFORMING
TEAM, OVERSEEING THE COMPLEX
PROCESS OF GRANTS MANAGEMENT.
SHELLEY REPRESENTED NCCIH IN THE
ADVISORY COMMITTEE, INTERACTING
WITH NCCIH GRANTEE INSTITUTIONS,
WE REALLY THANK HER FROM THE
BOTTOM OF OUR HEARTS FOR MANY
YEARS OF SERVICE AND WISH HER
ALL THE BEST.
AND TAKING OVER FOR SHELLEY IS
MISS DEBBIE CHEN WHO HAS A
WEALTH OF EXPERIENCE, RECENTLY
STARTED AT NCCIH, A WEALTH OF
EXPERIENCE IN GRANTS
MANAGESMENT, FOR SIX YEARS
DEPUTY GRANTS MANAGEMENT OFFICER
AT NHLBI, HEART, LUNG AND BLOOD
INSTITUTE.
PRIOR TO THAT DEBBIE WORKED IN
GRANTS MANAGEMENT AT A NUMBER OF
FEDERAL AGENCIES INCLUDING
NATIONAL OCEANIC AND ATMOSPHERE
ADMINISTRATION, NATIONAL
INSTITUTES OF STANDARDS AND
TECHNOLOGY, AND DEPARTMENT OF
HEALTH AND HUMAN SERVICES, AS
WELL AS GETTING HER START IN
GRANTS MANAGEMENT AT NHGRI.
SO PLEASE JOIN US IN WELCOMING
DEBBIE.
ALSO, PLEASE JOIN ME IN
WELCOMING TWO NEW PROGRAM
DIRECTORS.
DR. LIZ GINEXI, DIVISION OF
EXTRAMURAL RESEARCH, LIZ JOINS
THE CLINICAL RESEARCH BRANCH AND
WILL OVERSEE COMPONENTS OF NCCIH
PORTFOLIO ON COMPLEX STUDY
DESIGN AND METHODS INCLUDING
COMPUTATIONAL MODELING,
INTERVENTION OPTIMIZATION,
ARTIFICIAL INTELLIGENCE.
SHE WILL SERVE AS PROJECT
SCIENTIST FOR NIH DVA MANAGEMENT
COORDINATING CENTER AND SUBJECT
MATTER EXPERT FOR COMMON FUND
BRIDGE TO ARTIFICIAL
INTELLIGENCE PROGRAM.
ALSO, PLEASE WELCOME DR.
HORGUSLUOGLU, I HAVE TO KEEP
PRACTICING HOW TO SAY HER
WONDERFUL NAME, AS A PROGRAM
DIRECTOR IN BASIC AND
MECHANISTIC RESEARCH BRANCH OF
DIVISION OF EXTRAMURAL RESEARCH,
SHE IS COORDINATOR FOR NCCIH
SMALL BUSINESS RESEARCH
PROGRAMS, HER PORTFOLIO SUPPORTS
DEVELOPMENT OF FULL-PERSON
RESEARCH INVOLVING MULTI-SYSTEM
INTERACTIONS AND MULTI-COMPONENT
INTERVENTIONS WITH EMPHASIS ON
TECHNOLOGY, DATABASE, AND
COMPUTATIONAL METHODS
DEVELOPMENT AS WELL AS
DEVELOPMENT OF TECHNOLOGIES AND
METHODS TO MONITOR OR ENHANCE
MIND AND BODY INTERVENTIONS TO
SMALL BUSINESS FUNDING
MECHANISMS.
WE'VE BEEN RETHE VIEWING TO
ADVANCE NEW -- RECRUITING TO
ADVANCE NEW PROGRAMS.
AND WE CAN CONTINUE TO WORK
TOGETHER WITH DR. SABRI WHO
TRANSFERRED TO NIDCD PROGRAM
DIRECTOR -- AS PROGRAM DIRECTOR,
OVERSEEING THE CHEMOSENSORY
PORTFOLIO DIVISION, NATIONAL
INSTITUTE OF DEAFNESS AND
COMMUNICATION DISORDERS.
DR. DAVE CLARK TRANSFERRED TO
NATIONAL HEALTH INSTITUTE OF
HEART, LUNG AND BLOOD INSTITUTE,
HE'S GOING TO BE THERE, CHIEF
IMPLEMENTATION -- CHIEF OF
IMPLEMENTATION SCIENCE BRANCH.
AND DR. DELLA WHITE TO NIGMS,
CLINICAL RESEARCH STRATEGY
COORDINATOR IN OFFICE OF THE
DIRECTOR.
WE WISH THEM ALL WELL.
ALSO, IMPORTANT NEWS, DR. ROBIN
BOINEAU TRANSITIONED TO THE OCRA
DIRECTOR, CONGRATULATIONS TO
ROBIN.
WE HAVE A FEW NCCIH STAFF
ARRIVALS AND TRANSITIONS.
KELLY McGILL IS NEW, A
SCIENTIFIC PROGRAM ANALYST IN
THE DIVISION OF EXTRAMURAL
RESEARCH.
HAJER TO GRANTS MANAGEMENT
SPECIALIST.
JAMES THOMPSON WAS WITH
INTRAMURAL RESEARCH, NOW
ADMINISTRATIVE OFFICER IN
ADMINISTRATIVE OPERATIONS.
WE ALSO HAVE SOME NEW STAFF
ARRIVALS AND DEPARTURES IN
DIVISION OF INTRAMURAL RESEARCH.
ARRIVALS AND DEPARTURES.
AND NOW I WANT TO SAY A WORD
ABOUT THE NIH PRAGMATIC TRIALS
COLLABORATORY, THERE'S A FEW
THINGS HAPPENING IN THIS AREA.
THIS IS THE TENTH ANNIVERSARY OF
THE COLLABORATORY, AS WE CALL
IT.
AND ALSO THIS YEAR MARKS A VERY
IMPORTANT MILESTONE IN THE
COLLABORATORY, WHICH THAT IT'S
TRANSITIONING FROM THE COMMON
FUND TO FUNDING BY THE NIH
INSTITUTES AND CENTERS.
AND SO IT SEEMED LIKE THIS IS
GOING TO BE A GOOD OPPORTUNITY
FOR REBRANDING.
THE REASON FOR THAT IS BECAUSE
THE -- WE USED TO -- THERE ARE
SO MANY COLLABORATORIES NOW,
THERE IS -- IT WAS STARTING TO
BECOME CONFUSING THAT THERE'S A
PAIN MANAGEMENT COLLABORATORY,
THERE'S THE IMPACT COLLABORATORY
AT NIH.
AND SO WE WANTED TO HAVE A NAME
THAT WAS A LITTLE BIT MORE EASY,
BECAUSE HEALTH CARE SYSTEMS
RESEARCH COLLABORATORY WAS
DIFFICULT TO REMEMBER, WANTED
SOMETHING MORE EASY TO USE AS A
NAME BUT ALMOST THAT REFLECTED
THE OVERALL MISSION OF THE
COLLABORATORY, WHICH IS TO -- IN
THE MAIN PRAGMATIC
COLLABORATORY, THE NAME SEEMS TO
FIT.
WE DEFINE PRAGMATIC TRIALS AS
LARGE EFFICIENT STUDIES
ENCOMPASSING EFFECTIVENESS,
IMPLEMENTATION, DISSEMINATION.
WE FEEL THE NAME PRAGMATIC TRIAL
COLLABORATORY EMBRACES ALL OF
THAT.
SO, AS YOU SEE HERE, THE TOPICS
THAT THE PRAGMATIC TRIAL
COLLABORATORY HAS REALLY BECOME
EXPERTS AT EMBRACE A LOT OF
ISSUES FIRST AND FOREMOST IN
PEOPLE'S MINDS IN TERMS OF
PERFORMING IMPACTFUL CLINICAL
RESEARCH SUCH AS STUDIES
DESIGNED WITH INPUT FROM HEALTH
SYSTEMS STAKEHOLDERS, VERY
IMPORTANT.
INTERVENTIONS THAT CAN BE
INCORPORATED INTO THE ROUTINE
CLINICAL CARE, NOT RESEARCH
THAT'S PERFORMED IN A SETTING
THAT IS SEPARATE FROM CLINICAL
CARE.
DATA COLLECTED THROUGH
ELECTRONIC HEALTH RECORD, FOR
EXAMPLE, REPRESENTING THE
DIVERSE AND REPRESENTATIVE SITE
POPULATIONS, AND OUTCOMES
IMPORTANT.
THIS IS REALLY A --
COLLABORATORY HAS BECOME
IMPORTANT HELPING CONDUCT
RESEARCH IN THE BEST AND MOST
RIGOROUS WAY.
JUST TO SHOW HOW THIS EVOLVED,
FROM 2012 TO 2017 THE
COLLABORATORY WAS ENTIRELY
FUNDED BY THE NIH COMMON FUND.
THIS IS FUNDED BY OFFICE OF
DIRECTOR AT I. NO INCLUDING
FUNDING FOR COORDINATING CENTER
AS WELL AS CORE WORKING GROUPS
AND DEMONSTRATION PROJECTS.
IT WAS A TRANSITION PERIOD WHERE
THE NIH INSTITUTES AND CENTERS
STARTED TO ASSUME SOME PARTIAL
FUNDING OF COORDINATING CENTER
AS WELL AS DEMONSTRATION
PROJECTS.
IN 2019 THERE WAS ADDITIONAL
FUNDING FROM THE HEAL INITIATIVE
TO FUND A NUMBER OF PROJECTS IN
THE AREA OF PAIN, OPIOID USE
DISORDERS.
AND FINALLY NOW AS YOU CAN SEE
IF THE COMMON FUND IS GOING
AWAY.
UNDER LEADERSHIP OF NCCIH AND
NIA, CO-LEADS IN THIS, WE'VE
BEEN ABLE TO ASSEMBLE A GROUP OF
NIH INSTITUTES THAT AGREED TO
CONTINUE FUNDING THE ENTIRETY OF
THE COLLABORATORY, INCLUDING
COORDINATING CENTER, AS WELL AS
DEMONSTRATION PROJECTS.
SO HERE ARE ALL THE INSTITUTES
THAT AGREED TO CONTINUE,
NATIONAL CANCER INSTITUTE, HEART
LUNG HEART, LUNG AND BLOOD,
MINORITY HEALTH AND HEALTH
DISPARITIES, NURSING, OFFICE OF
BEHAVIORAL AND SOCIAL SCIENCES
RESEARCH AND OFFICE OF DISEASE
PREVENTION, SO YOU CAN SEE
THERE'S BEEN AN IMPRESSIVE GROUP
OF INSTITUTES AND CENTERS THAT
HAVE AGREED TO CONTINUE ON.
THIS IS VERY IMPORTANT BECAUSE
THE WHOLE GOAL OF THESE COMMON
FUND FUND PROJECTS, THEY ARE
GUARANTEE.
IT'S TEN YEARS TYPICALLY, AFTER
THAT EXPECTED PROJECTS WILL
CONTINUE BUT NOT ALWAYS THE CASE
SO THIS IS A REALLY SUCCESS
STORY.
AS FAR AS THE NEW PHASE OF THE
COLLABORATORY, THERE'S GOING TO
BE THIS AREA OF FOCUS THAT'S
GOING TO SHIFT TO INCLUDE
IMPLEMENTATION SCIENCE TRIALS,
THAT STUDY STRATEGIES FOR
IMPLEMENTING EVIDENCE-BASED
INTERVENTIONS INTO HEALTH CARE
DELIVERY SO REALLY EXTENDING THE
EMPHASIS FROM EFFICACY TO
IMPLEMENTATION, PUTTING ALL OF
THIS INTO THE SCOPE OF THE
STRUCTURE.
FINALLY, WE'VE ALSO ELECTED TO
FOCUS ON HEALTH DISPARITIES AND
HEALTH CARE DELIVERY AS A NEW
FOCUS WHICH HAS ALLOWS US TO
ATTRACT A LOT OF OTHER
INSTITUTES TO THIS EFFORT.
WE'RE PLEASED AT HOW THIS IS
EVOLVING.
THE NEXT THING IS GOING TO BE
BUDGET UPDATES.
THIS IS THE SAME AS WHAT I
SHOWED YOU BACK AT THE LAST
COUNCIL IN SEPTEMBER.
THIS ILLUSTRATES THAT IF YOU
LOOK HERE AT -- EXCUSE ME HERE.
THIS IS CUT OFF ON MY SCREEN.
SORRY ABOUT THAT.
BUT BASICALLY BOTTOM LINE IS
THAT WE HAVE HAD A SORT OF
MODEST INCREASE IN BUDGET FROM
2020 TO 2021.
WE OF COURSE DO NOT KNOW YET
WHAT THE BUDGET WILL BE FOR
2022.
THE PRESIDENT'S BUDGET SUBMITTED
INCLUDING A RATHER LARGE
INCREASE, I DON'T KNOW IF YOU
CAN SEE AT THE BOTTOM, TO $184
MILLION.
BECAUSE WE'RE STILL IN A
CONTINUING RESOLUTION WE HAVE NO
IDEA EXACTLY WHAT THIS BUDGET
WILL BE.
BUT AN INTERESTING AND IMPORTANT
PART OF THIS WAS THAT THIS BILL
HERE THAT PROPOSED THIS INCREASE
FOR FY 22 INCLUDED A RATHER
SUBSTANTIAL INCREASE ARE $26
MILLION SPECIFICALLY FOR NCCIH
TO SUPPORT RESEARCH RELATED TO
MAIN -- PAIN AND PAIN
MANAGEMENT.
WE DON'T KNOW WHETHER THIS
BUDGET IS GOING TO PASS.
WE DON'T KNOW WHETHER THIS $26
MILLION IS OR ISN'T GOING TO BE
ALLOCATED TO US.
WE'RE NOT ABLE TO SAY THAT RIGHT
NOW THIS BILL HAS PASSED IN THE
HOUSE, BUT NOT PASSED IN THE
SENATE, SO WE DON'T KNOW WHAT'S
GOING TO HAPPEN WITH IT.
HOWEVER, WE WANT TO BE
PREPARED,JUST IN CASE THIS DOES
COME OUR WAY.
AND BECAUSE WE'RE ALREADY
GETTING PRETTY ADVANCED IN
FISCAL YEAR, WE WANTED TO HAVE A
VARIETY OF DIFFERENT OPTIONS FOR
SPECIFIC INITIATIVES THAT DR.
EMMELINE EDWARDS WILL TELL YOU
ABOUT AFTER MY REPORT, TELLING
YOU ABOUT SPECIFIC INITIATIVES
WE'RE PUTTING TOGETHER BOTH AT
NCCIH, ALSO VERY IMPORTANTLY IN
COLLABORATION WITH MANY OTHER OF
OUR COLLEAGUES AND OTHER
INSTITUTES AND CENTERS AT NIH AS
WELL AS THE HEAL INITIATIVE.
EMMELINE WILL TELL US ABOUT
THAT.
ANOTHER IMPORTANT EVENT THAT
OCCURRED, THERE WAS A
CONGRESSIONAL BRIEFING WITH
REPRESENTATIVE JACKIE WALORSKI,
CO-CHAIR OF THE INTEGRATIVE
HEALTH CAUCUS, INTERESTED IN OUR
WHOLE PERSON HEALTH NEW
STRATEGIC PLAN.
AND WE'RE PLANNING TO FOLLOW UP
ON THIS WITH THE ENTIRE CAUCUS.
THERE WAS A BRIEFING OF NIH
LEADERSHIP AND INSTITUTES AND
CENTERS WITH THE DEMOCRATIC
WOMEN'S CAUCUS, WHICH WAS ALSO
GENERATING A LOT OF INTEREST.
I NOW WANT TO TAKE A COUPLE
MINUTES TO REALLY THANK OUR
GRANTEE COMMUNITY.
ABOUT HOW THE RESPONSE TO THE
COVID-19 PANDEMIC HAS BEEN JUST
SO IMPRESSIVE AMONG RESEARCHERS.
OUR INVESTIGATORS, A HUGE HURDLE
WITH THE COVID-19 PANDEMIC, DID
NOT TREAT IT AS AN IMPOSSIBLE
FEAT THEY WERE UNABLE TO ADDRESS
BUT INSTEAD WERE THOUGHTFUL AND
CAREFUL IN WHAT COULD BE DONE
WITHIN THE FRAMEWORK OF PUTTING
SAFETY FIRST AND ALSO ADAPTING
WITHIN LIMITATIONS OF AVAILABLE
RESOURCES INCLUDING TIME, STAFF,
ACCESS TO HUMAN SUBJECTS, AND SO
ON.
SO, OUR INVESTIGATORS ASSESS
LANDSCAPE, CHOSE A PATH FORWARD,
REVISING STUDY DESIGNS WHEN
APPROPRIATE THAT WOULD LIKELY
WORK GIVEN THE PANDEMIC'S
CONSTRAINTS.
AND WE WERE VERY IMPRESSED WITH
PILOT TESTING AS NEEDED, PEOPLE
BROUGHT IN EXPERTISE AS THEY
REVISED APPROACHES WITH GREAT
DEAL OF COLLABORATION ACROSS
STAKEHOLDERS AND COMMUNICATIONS
ABOUT WHAT WAS GOING, AS THINGS
EVOLVED.
WE WERE VERY IMPRESSED WITH THE
RESPONSE TO THE SCIENTIFIC
COMMUNITY AND THANK YOU FOR YOUR
HARD WORK THROUGH THESE
DIFFICULT TIMES.
REGARDING WHAT'S GOING ON AT
NIH, IN RESPONSE TO THE COVID
PANDEMIC, NIH LAUNCHED A VERY
IMPORTANT RECOVER INITIATIVE,
WHICH MEANS RESEARCHING COVID TO
ENHANCE RECOVERY TO LEARN WHY
SOME PEOPLE HAVE PROLONGED
SYMPTOMS REFERRED TO AS LONG
COVID OR DEVELOP NEW OR
RECURRING SYMPTOMS AFTER THE
ACUTE PHASE OF INFECTION OF
SARS-COV-2.
THESE SYMPTOMS ARE TROUBLESOME
INCLUDING PAIN, HEADACHE,
FATIGUE, BRAIN FOG THAT A LOT OF
PEOPLE COMPLAIN ABOUT, SHORTNESS
OF BREATH.
AND SO NIH HAS PUT IN A VERY
LARGE EFFORT, $470 MILLION, TO
BUILD A NATIONAL STUDY
POPULATION OF DIVERSE
INDIVIDUALS AND SUPPORT LARGE
SCALE STUDIES ON LONG-TERM
EFFECTS OF COVID-19.
THE RECOVER INITIATIVE MADE
PARENT AWARD TO NEW YORK
UNIVERSITY, MAKING MULTIPLE
SUBAWARDS TO 100 RESEARCHERS AT
30 INSTITUTIONS AND SERVE AS
RECOVER CLINICAL SCIENCE CORE.
THIS MAJOR NEW AWARD TO NYI
LANGONE LEVERAGES LONG-RUNNING
COHORT STUDIES AND SO WE'RE VERY
INTERESTED AT NCCIH,
PARTICULARLY IN THE AREA OF
STRESS AND RECOVERY FROM
SARS-COV-2 INFECTION, AND ITS
POTENTIAL ROLE IN POST-ACUTE
SYNDROME.
NCCIH WAS CLOSELY INVOLVED IN
DESIGN OF THE RECOVER INITIATIVE
AND THERE WILL BE MANY
OPPORTUNITIES TO TEST PHYSICAL,
PSYCHOLOGICAL INTERVENTIONS AS A
FOLLOW-UP TO THE COHORTS.
I WANT TO TAKE A LOOK AT SOME
RECENT NCCIH RESEARCH
HIGHLIGHTS.
FIRST OF ALL, THIS IS AN
INTERESTING STUDY, A COMPONENT
OF THE TULSI, HOLY BASIL,
TREATING COVID-19.
THIS COMPOUND INHIBITED
INTERACTION BETWEEN SPIKE
PROTEIN AND ACE-2 RECEPTORS, AND
ALSO INHIBITED BINDING OF SPIKE
PROTEIN TO THE COVID VIRUS,
SARS-COV-2 VIRUS, ENHANCING
BEHAVIOR IN MICE.
STILL TOO EARLY TO KNOW, THIS
HAS NOT BEEN TESTED IN HUMANS,
BUT VERY INTERESTING INDEED.
AND USING GREEN LIGHT IN A MOUSE
MODEL OF PAIN.
THIS IS ALSO VERY INTERESTING
BECAUSE THIS GREEN LIGHT OF NOT
ONLY REDUCED PAIN BUT ALSO BETA
ENDORPHINS, AND HERE YOU CAN SEE
THERE'S THIS MARKED REVERSAL OF
PAIN SENSITIVITY, HIV-RELATED
MODEL OF NEUROPATHIC PAIN.
ANOTHER INTERESTING STUDY OF
BACK PAIN, ASSOCIATION OF BACK
PAIN WITH MORTALITY.
WE KNOW, IT WAS NOT CLEAR, WE
KNOW IT'S ASSOCIATED WITH GREAT
MORBIDITY BUT WASN'T CLEAR
WHETHER DISABILITY IS GENERALLY
ASSOCIATED WITH MORTALITY.
THIS PARTICULAR STUDY LOOKED AT
81,000 PARTICIPANTS FOLLOWED FOR
5 TO 23 YEARS, AND PRESENCE OF
ANY BACK PAIN COMPARED TO NONE,
WAS NOT ASSOCIATED WITH INCREASE
IN MORTALITY, WAS ASSOCIATED
WITH INCREASE IN MORTALITY IN
WOMEN AND ADULTS WITH MORE
SEVERE BACK PAIN.
AND FINALLY I WANT TO POINT OUT
THIS STUDY TALKING ABOUT THE
HEALTH CARE SYSTEMS RESEARCH
COLLABORATORY, PRAGMATIC TRIALS
COLLABORATORY, AND THIS IS A
STUDY THAT WAS RECENTLY
PUBLISHED, THAT REALLY
HIGHLIGHTS SOME OF THE
IMPORTANT -- WHAT WE'VE LEARNED
ABOUT USING ELECTRONIC HEALTH
RECORD IN PRAGMATIC TRIALS.
AND SO I ENCOURAGE YOU TO CHECK
THIS OUT.
IT'S A VERY NICE SUMMARY OF
LESSONS LEARNED IN THE PRAGMATIC
TRIALS COLLABORATORY.
I WANT TO RUN THROUGH SOME
FUNDING OPPORTUNITIES, POINTING
OUT TO YOU THAT WE HAVE
RECEIVED, FOR EXAMPLE, THIS
PARTICULAR ONE IS AN RFA OF THE
HEALTH CARE SYSTEMS RESEARCH
COLLABORATORY THAT WE ALREADY
HAD ONE RECEIPT DATE IN THE
FALL, AND I WANT TO POINT OUT
THERE'S ANOTHER RECEIPT DATE IN
JUNE 18.
AND THIS IS FOR PRAGMATIC AND
IMPLEMENT TRIALS OF EMBEDDED
INTERVENTIONS, SO WANT TO ALERT
YOU HERE OF THAT ADDITIONAL
RECEIPT DATE.
THERE'S ANOTHER OPPORTUNITY FOR
FUNDING FROM THE NIH, PAIN
MANAGEMENT COLLABORATORY FOR
PRAGMATIC AND IMPLEMENTATION
SCIENCE DEMONSTRATION PROJECTS,
ON MARCH 16.
THIS IS ALSO A NOTICE OF SPECIAL
INTEREST FOR SUPPLEMENTS ON HIGH
PRIORITY TOPIC AREAS FOR GRANTS
INCLUDING NATURAL PRODUCTS, MIND
AND BODY APPROACHES, AND
FUNDAMENTAL SCIENCE AND
TECHNOLOGY, AS WELL AS CLINICAL
RESEARCH.
AND SO THIS IS ALSO -- THE DUE
DATE IS JUNE 2.
THERE'S ALSO AN OPPORTUNITY HERE
FOR EXISTING NCCIH-FUNDED
PERSONS TO NATIONAL RESEARCH
SERVICE AWARDS, T32 PROGRAMS TO
APPLY FOR SUPPLEMENTS TO SUPPORT
CANDIDATES FROM DIVERSE
BACKGROUNDS INCLUDING
UNDERREPRESENTED IN THE
BIOMEDICAL, CLINICAL,
BEHAVIORAL, SOCIAL SCIENCES.
AND THIS IS ANOTHER OPPORTUNITY
FOR EXISTING NCCIH-FUNDED
RESEARCH SERVICE AWARDS,
INSTITUTIONAL RESEARCH TRAINING
GRANTS, T32 PROGRAMS, TO APPLY
FOR OTHER TIMES OF SUPPLEMENTS
TO SUPPORT ADDITIONAL TRAINING
SLOT TO SUPPORT PRE-DOCTORAL AND
POSTDOCTORAL CANDIDATES WITH
INTEGRATIVE HEALTH DEGREES.
ALSO, THIS NOTICE OF SPECIAL
INTEREST TO HIGHLIGHT INTEREST
IN RESEARCH TO STRENGTHEN
UNDERSTANDING AND RESPONSE TO
COVID-19 PANDEMIC.
AND HELP US PREPARE FOR FUTURE
PUBLIC HEALTH EMERGENCIES.
SO, THE PURPOSE OF THIS NOTICE
IS TO EMPHASIZE THE ROLE OF
INTERVENTION ON INDIVIDUAL
HEALTH AND COMMUNITY ENGAGED
INTERVENTION IN HEALTH CARE
SETTINGS TO ADDRESS ACCESS,
DELIVERY, ENGAGEMENT,
SCALABILITY, SERVICES UTILIZED
DURING AND FOLLOWING THE
PANDEMIC.
A FEW WORDS ABOUT HEAL
INITIATIVE-RELATED ITEMS.
WE HAD A FANTASTIC TURNOUT FOR
OUR MEETING IN JULY, APPROACHES
TO EFFECTIVE THERAPEUTIC
MANAGEMENT OF PAIN FOR PEOPLE
WITH SICKLE CELL DISEASE, AND
POSTED ON THE WEBSITE.
WE HAD A HEAL INITIATIVE RFA,
NOW CLOSED.
AND APPLICATIONS ARE CURRENTLY
UNDER REVIEW.
ALSO, COUNSEL SILL APPROVED THIS
CONCEPT FOR THE MYOFASCIAL PAIN
HEAL INITIATIVE, DEVELOPING
BIOMARKERS, IMPORTANTLY THIS RFA
IS STILL OPEN.
DEADLINE IS FEBRUARY 12.
WE HAD A SEMINAR ON DECEMBER 2
IF YOU'RE STILL INTERESTED IN
LOOKING AT THIS, VIDEOCAST IS
AVAILABLE ONLINE.
WE ALSO HAD A RESEARCHING
NETWORKING SESSION ON JANUARY 6
TO PAIR UP PEOPLE WHO ARE
INTERESTED IN DOING RESEARCH
FROM THE CLINICAL SIDE,
CLINICIANS WITH EXPERTISE IN
MYOFASCIAL PAIN SYNDROME, WITH
TOOL DEVELOPERS FOR ENGINEERING,
PEOPLE WHO HAVE EXPERTISE IN
DEVELOPING IMAGING OR OTHER
TYPES OF BIOMARKERS.
THERE'S STILL SOME TIME.
BUT IT'S COMING UP SOON.
FINALLY, I WANT TO MENTION THIS
NEW INITIATIVE WHICH WE'RE GOING
TO TALK ABOUT AGAIN THIS
AFTERNOON, DR. CRISWELL FROM
NATIONAL INSTITUTES OF ARTHRITIS
IS GOING TO TALK ABOUT THIS HEAL
INITIATIVE OF JOINT PAIN,
RESTORING JOINT HEALTH AND
FUNCTION TO REDUCE PAIN CALLED
RE-JOIN.
AGAIN, THE DEADLINE IS APRIL 12.
AND ALSO THERE'S GOING TO BE A
TECHNICAL ASSISTANCE WEBINAR FOR
THIS ON WEDNESDAY, FEBRUARY 9.
SO THIS IS POSTED ON THE NIAMS
WEBSITE.
AGAIN, WE'LL BE HEARING MORE
ABOUT THIS THIS AFTERNOON.
PAST ACTIVITIES AND EVENTS, WE
HAD A FANTASTIC WORKSHOP FOR
APPROACH TO WHOLE PERSON HEALTH.
AND THIS WORKSHOP ALSO THE VIDEO
IS ON THE WEBSITE, WE'LL HAVE A
SUMMARY FAIRLY SOON.
THIS LOOKED AT HOW TO STUDY
INTERCONNECTED SYSTEMS, IMPACT
OF SINGLE COMPONENT INTERVENTION
ON MULTIPLE SYSTEMS, IMPACT OF
MULTIPLE COMPONENT ON BOTH
SINGLE OUTCOMES AND MULTI-ORGAN
OUTCOMES.
FASCINATING ACTION ITEM, WE'RE
GOING TO FOLLOW UP WITH THIS
WITH MANY DIFFERENT TYPES OF
FUNDING INITIATIVES.
WE HAD A WONDERFUL INTEGRATIVE
MEDICINE RESEARCH LECTURE, DR.
YOUNG PRESENTED ON READING
BETWEEN THE TWEETS, VIDEOCAST IS
AVAILABLE.
THE STRESS LECTURE WAS WONDERFUL
THIS YEAR.
MINDFULNESS AS A SUPPORT FOR
HEALING CONVERSATIONS TOWARD
SOCIAL JUSTICE INEQUITY, WANDA
MAGEE GAVE A FANTASTIC LECTURE,
WATCH IF YOU'RE INTERESTED ON
OUR VIDEOCAST ON THE WEBSITE.
COMING EVENTS, SAVE THE DATE,
WE'LL HAVE A WORKSHOP ON
PRECISION PROBIOTICS, APRIL
26-27.
GOAL IS TO IDENTIFY KNOWLEDGE
GAPS FROM CURRENT METHODOLOGY
AND CHALLENGE IN PROBIOTIC
RESEARCH, FUTURE DIRECTIONS OF
THERAPIES.
AND SO AGAIN THE LINK IS ON THE
WEBSITE.
THE ANNUAL PAIN CONSORTIUM
SYMPOSIUM, THIS YEAR JUNE 1 AND
2, FOCUSING ON PAIN MANAGEMENT
FOR THE LENS OF WHOLE PERSON
HEALTH.
THIS SHOULD BE VERY INTERESTING.
SAVE THE DATE.
ALSO, INTERNATIONAL CONSORTIUM
FOR CONGRESS, EXCUSE ME,
INTEGRATIVE MEDICINE AND HEALTH
IN PHOENIX IN MAY, ORGANIZED BY
NCCIH, CAREER DEVELOPMENT,
TRANSLATING YOUR RESEARCH,
HARNESSING MUSIC INTERVENTIONS,
MINDFULNESS-BASED TREATMENT FOR
CHRONIC PAIN OR OPIOID MISUSE,
SCIENCE AND PRACTICE OF
CANNABINOID-BASED THERAPIES,
PAIN MANAGEMENT COLLABORATORY,
PRAGMATIC TRIALS, GUT
MICROBIOME, ALTERNATIVES TO
OPIOIDS, GLYMPHATIC AND
LYMPHATIC CLEARANCE AND SLEEP.
CHECK OUT THIS FANTASTIC LINEUP
OF SYMPOSIA AND HOPEFULLY WE'LL
SEE YOU IN PERSON, IF NOT IN
JUNE, FOR THE MEETING.
ICIMH, I'LL HAVE A SYMPOSIUM
WITH DR. SUZANNE SIMARD,
RESEARCHER ON FORESTRY, IMPACT
ON HUMANS AND FORESTS.
AND DR. SIMARD IS A PIONEER IN
PROMOTING ECOLOGICAL AND WHOLE
FOREST MANAGEMENT OF NATURE, AND
SO WE'RE GOING TO LOOK FORWARD
TO A BIG CONVERSATION BETWEEN
THE TWO OF US, WE FEEL THERE'S A
LOT OF PARALLEL WITH WHAT SHE'S
ADVOCATING AND WHAT WHAT WE'RE
WORKING ON, THE SUBJECT OF WHOLE
PERSON HEALTH.
AND FINALLY, OUR NEXT NCCIM
MEETING, MEETING WITH THE
COUNCIL, ADVISORY COUNCIL FOR
THE COMPLEMENTARY AND
INTEGRATIVE HEALTH, IS ON MAY
13.
AND PLEASE SAVE THE DATE FOR
THAT.
SO I'M NOW OVER TIME BUT I'M
GOING TO PAUSE.
I'LL STOP MY SHARE AND SEE IF WE
WANT TO GIVE DR. EDWARDS A
CHANCE TO PRESENT HER -- DO WE
HAVE TIME FOR QUESTIONS OR
SHOULD WE MOVE TO EMMELINE?
>> GOOD QUESTION.
I DID WANT TO SEE IF THERE ARE
QUESTIONS FROM COUNCIL RELATED
TO DR. LANGEVIN'S PRESENTATION.
WE'RE ALSO RUNNING UP AGAINST
THE LUNCH HOUR, LUNCH HALF HOUR.
>> I APOLOGIZE, I WENT OVER.
>> WE COULD MOVE EMMELINE'S TALK
TO THIS AFTERNOON.
>> I'M FINE WITH THAT.
>> THAT WOULD GIVE COUNCIL
MEMBERS, IF THEY HAVE ANY
QUESTIONS, BECAUSE WE'RE
SCHEDULED TO BREAK FOR LUNCH
LITERALLY SORT OF NOW.
COUNCIL?
WHAT SAY YE?
DR. HANEY?
>> DO WE HAVE SENSE OF WHEN THE
BUDGET MIGHT GET APPROVED?
IS THERE ANY GUESS AT ALL?
>> NO GUESS.
WE'RE HOLDING OUR BREATH AND
WAITING.
>> THANKS.
>> OTHER QUESTIONS OR COMMENTS
BY COUNCIL?
YEAH, WOLF?
>> IF THIS COMES THROUGH, THE
BUDGET INCREASE, IS THERE A
CHANCE THAT A 10% CUT IN
RESEARCH BUDGETS FOR R34 FOR
YEAR TWO CAN BE REVERSED?
>> ALL OF THIS WILL HAVE BEEN TO
BE TAKEN INTO CONSIDERATION,
ONCE WE KNOW THE AMOUNT OF MONEY
THAT WE HAVE.
>> OKAY.
>> WHEN WE'RE IN A CONTINUING
RESOLUTION, AS WE ARE RIGHT NOW,
THERE ARE CERTAIN BUDGET CAPS
WE'RE REQUIRED TO DO, JUST
BECAUSE WE'RE CONTINUING
RESOLUTION, AND THEN WE HAVE TO
SEE ONCE WE GET OUR ACTUAL
BUDGET, WE CAN ASSESS WHAT WE
CAN DO AT THAT POINT.
>> YEAH.
>> THANK YOU.
>> TO BE EXPLICIT, WE HAVE
CONTINUING RESOLUTIONS, WE'RE
REQUIRED BY POLICY OR REGULATION
ACTUALLY TO NOT FUND THE
COMPETING AWARDS, BUT THE
NON-COMPETING AWARDS AT 100%, IT
USUALLY GETS CAPPED AT 90%.
AND IF AND WHEN WE GET A BUDGET,
DEPENDING UPON THE BUDGET THAT
WE ACTUALLY GET, WE CAN CONSIDER
RESTORING SOME OR ALL OF THAT
FUNDS THAT HAVE BEEN HELD BACK
FOR THAT YEAR.
WE DO THIS AUTOMATICALLY,
THERE'S NO NEED FOR ANY AWARDEE
TO CONTACT AND SAY COULD YOU
GIVE ME THE MONEY THAT WE DIDN'T
GET.
WE WILL DO THAT AUTOMATICALLY IF
WE HAVE THE MONEY AND ONCE WE
GET A BUDGET.
>> THANK YOU, THANK YOU.
>> DR. LABREKSKY?
>> A QUESTION ABOUT LONG COVID
FUNDING.
STRUCTURE OF THE FUNDING
DECISIONS IS CUMBERSOME, NOT
CLEAR HOW INSTITUTES WOULD MAKE
THE DECISIONS ON FUNDING WHEN
NYU IS IN THE MIDDLE OF IT.
>> WELL, IT'S MY UNDERSTANDING
THAT THEY ARE WORKING TOGETHER
WITH NIH.
THIS IS -- THEY ARE USING WHAT'S
CALLED THE OTHER TRANSACTION
AUTHORITY TO MAKE THIS
PARTICULAR FUNDING AWARD.
AND DECISIONS LIKE THIS ARE MADE
VERY MUCH IN TANDEM BETWEEN NIH
AND NYU, COLLABORATION GOING ON
BOTH WAYS THE WHOLE TIME.
THIS IS A VERY, YOU KNOW, HIGH
INTENSITY PROJECT, AS YOU CAN
IMAGINE.
ALL OF THIS HAS TO HAPPEN IN
VERY, VERY SHORT AMOUNTS OF
TIME.
SO NIH HAS A LOT OF INPUT INTO
THIS.
>> AND WHAT I FIND BAFFLING,
BECAUSE OF THIS OTHER FUNDING,
THE INSTITUTES ARE NOT WILLING
TO ENGAGE IN THE DISCUSSION OF
OTHER PROJECTS.
YOU KNOW, BECAUSE IT'S
2.5 BILLION ALLOCATED, AND WHAP
IS THE NCCIH POSITION ON THAT
AND HOW DO I APPROACH IT?
>> WE DON'T HAVE ANY AUTHORITY
OVER THAT.
I MEAN, THIS IS ALL HANDLED BY
THE -- YOU KNOW, THE ENTIRE -- I
BELIEVE THIS IS THE OFFICE OF
THE DIRECTOR THAT'S ORGANIZING
THIS, BUT IT'S A
MULTI-INSTITUTE, YOU KNOW,
CONSORTIUM.
WE CANNOT INFLUENTIAL HOW THAT
PARTICULAR -- I MEAN, I SIT ON
THE EXECUTIVE COMMITTEE FOR THE
PAST, AND I CAN TELL YOU THAT
THE WAY THAT THIS HAS BEEN
HAPPENING HAS BEEN -- HAS BEEN
DONE VERY, VERY CAREFULLY BUT
ALSO AT THE SAME TIME UNDER
TREMENDOUS TIME CONSTRAINTS.
YOU KNOW, PEOPLE DID THE BEST
THEY COULD UNDER THESE VERY
DIFFICULT CIRCUMSTANCES.
>> THE LAST QUESTION BEFORE THE
BREAK, WE'LL BREAK AFTER THIS
Q&A AND THEN WE CAN -- WE'LL
HAVE TIME LATER THIS AFTERNOON
WHEN WE COME BACK FROM LUNCH TO
HAVE MORE OPEN QUESTIONS AND
DISCUSSION WITH COUNCIL ON
VARIOUS THINGS.
>> THANKS FOR THAT WONDERFUL
OVER OVERVIEW OF THE EXCITING
PROGRAMS NCCIH IS INVOLVED IN OR
SPEARHEADING.
RELATED TO BUDGE IT, IT'S VERY
WONDERFUL TO SEE POTENTIAL FOR
BIG BUDGET INCREASE.
IT LOOKED LIKE THE DELTA BETWEEN
LAST YEAR AND THIS YEAR MIGHT BE
DUE TO -- I THINK YOU MENTIONED
SIGNIFICANT INCREASE IN FUNDING
FOR PAIN RESEARCH SPECIFICALLY.
IS THAT -- DID I INTERPRET THAT
CORRECTLY, IF TRUE FUNDS COME IN
EARMARKED FOR SPECIFIC PROGRAMS
LIKE THAT?
>> WELL, IF THIS WERE TO
HAPPEN, THIS PARTICULAR AMOUNT
OF 26 MILLION I MENTIONED WOULD
BE FOR PAIN RESEARCH ONLY.
AND BUT NOT FOR SPECIFIC
PROJECTS.
IT WOULD HAVE TO BE FOR PAIN
RESEARCH.
AND SO BUT WE DON'T KNOW OF
COURSE IF THIS IS GOING TO
HAPPEN OR NOT.
>> THANK YOU.
>> OKAY.
>> AND THIS IS WHAT -- EMMELINE
IS GOING TO TELL US ABOUT SOME
OF THE -- OF WHAT WE'RE THINKING
ABOUT IN TERMS OF CREATING
OPPORTUNITIES THAT COULD TURN
AROUND REALLY, REALLY QUICKLY
BECAUSE ALL OF THIS WOULD HAVE
TO BE IN FY22.
AND THERE'S NOT A LOT OF TIME
LEFT.
WE HAVE TO BE PREPARED IN CASE
THIS HAPPENS? WE'RE GOING TO
BREAK FOR LUNCH.
EMMELINE WILL DO A PRESENTATION
AFTER LUNCH, A SLOT AROUND 2:30
SHE WILL PRESENT THAT.
SO FOR COUNCIL MEMBERS, WE WILL
RETURN PROMPTLY AT 1:20 FOR THE
CONTINUATION OF THE OPEN
SESSION.
COUNCIL MEMBERS CAN TAKE LUNCH
ON THEIR OWN OR IF YOU WOULD
LIKE TO HAVE THE OPPORTUNITY TO
SORT OF EAT LUNCH WITH NCCIH
STAFF, IT WILL BE A LUNCH ROOM
BREAK OR LUNCHROOM THAT YOU'LL
BE INVITED TO JOIN VIA ZOOM, AND
YOU CAN JUST COME IN.
THERE WILL BE STAFF ALSO HAVING
LUNCH, YOU'RE WELCOME TO TALK
WITH STAFF AND COUNCIL MEMBERS
DURING YOUR LUNCH AND WE'LL ALL
RETURN FOR THE OPEN SESSION
WHICH WILL BE VIDEOCAST AT 1:20.
LUNCH BREAK IS NOT VIDEOCAST.
SO YOU'RE WELCOME TO JUST GO ON
YOUR OWN OR JOIN US OF SOME
STAFF IN THE LUNCH BREAK.
I'M GOING TO CONCLUDE THIS
PORTION OF THE OPEN SESSION.
WE'LL RETURN AT 1:20.
THANK YOU.
>> WELCOME BACK.
WE'RE COMING BACK FROM LUNCH
BREAK, CONVENING THE OPEN
SESSION OF THE ADVISORY COUNCIL.
I HOPE EVERYONE GOT A LUNCH
BREAK, ET CETERA.
WE'RE NOW GOING INTO OUR NEXT
PRESENTATIONS.
DR. LANGEVIN, WOULD YOU LIKE TO
INTRODUCE DR. CRISWELL?
>> WELL, IT'S MY GREAT PLEASURE
TO INTRODUCE DR. LINDSEY
CRISWELL, WHO IS DIRECTOR OF THE
NATIONAL INSTITUTES FOR
ARTHRITIS AND MUSCULOSKELETAL
AND SKIN DISEASE AT NIH.
IT'S REALLY A PRIVILEGE FOR US
TO HAVE DR. CRISWELL PRESENT.
WE'RE EXCITED.
SHE BECAME DIRECTOR OF NIAMS A
YEAR AGO.
SINCE THEN SHE'S BEEN A
WONDERFUL COLLEAGUE AND WE'RE
LOOKING FORWARD TO
COLLABORATIONS IN THE AREA OF
MUSCULOSKELETAL PAIN.
DR. CRISWELL OVERSEES INTO THE
CAUSES, TREATMENT AND PREVENTION
OF ARTHRITIS AND MUSCULOSKELETAL
AND SKIN DISEASE, BOARD
CERTIFIED RHEUMATOLOGIST,
PREVIOUSLY VICE CHANCELLOR OF
RESEARCH UNIVERSITY OF
CALIFORNIA, SAN FRANCISCO,
PROFESSOR OF RHEUMATOLOGY,
DISTINGUISHED PROFESSORSHIP ALSO
IN RHEUMATOLOGY, OBTAINED
MASTER'S DEGREE IN PUBLIC HEALTH
UNIVERSITY OF CALIFORNIA
BERKELEY, M.D. UCSF, DSC IN
GENETIC EPIDEMIOLOGY FROM
NETHERLANDS INSTITUTES FOR
HEALTH SCIENCES IN ROTTERDAM.
SHE WAS PRINCIPAL INVESTIGATOR
OF MULTIPLE GRANTS, PUBLISHED
250 PEER-REVIEWED ARTICLES
FOCUSED ON GENETICS AND
EPIDEMIOLOGY OF HUMAN AUTOIMMUNE
DISEASE, ESPECIALLY RHEUMATOID
ARTHRITIS AND SYSTEMIC LUPUS.
WELCOME, DR. CRISWELL.
WE'RE EXCITED TO HEAR ABOUT WHAT
YOU CAN TELL US ABOUT DIRECTIONS
YOU'RE TAKING NIAMS AND AREAS
WHERE WE CAN COLLABORATE.
>> THANK YOU.
I APPRECIATE THE INVITATION, MY
FIRST OPPORTUNITY TO PRESENT TO
ANOTHER COUNCIL.
LET ME TRY TO SHARE MY SCREEN.
GIVE ME A MOMENT.
CAN YOU SEE THAT OKAY?
>> YES.
>> GREAT.
OKAY.
SO, GOOD AFTERNOON.
IT'S A PLEASURE TO BE HERE, I
APPRECIATE THE OPPORTUNITY TO
SHARE HIGHLIGHTS OF THE PAIN
PORTFOLIO.
MY AGENDA IS PROVIDE HIGHLIGHTS
OF SHARED INTEREST IN PAIN
RESEARCH, I LOOK FORWARD TO A
ROBUST DISCUSSION WITH YOU.
I'M EXCITED TO OVERSEE THE WIDE
RANGING PORTFOLIO AND
OUTSTANDING WORK THAT THE
INSTITUTE SUPPORTS.
SINCE JOIN NIAMS I'VE BEEN
GETTING TO KNOW FELLOW DIRECTORS
AND EXPLORING WAYS WE CAN
PARTNER IN AREAS OF COMMON
INTEREST.
IT'S BEEN PARTICULARLY ENJOYABLE
TO MEET AND INTERACT WITH DR.
LANGEVIN, TO IDENTIFY MANY
SHARED INTERESTS AND NEW
COLLABORATIVE OPPORTUNITIES.
I'M GOING TO BEGIN WITH A BRIEF
INTRODUCTION TO NIAMS FOR THOSE
NOT FAMILIAR INCLUDING OUR
CURRENT BUDGET AND STRATEGIC
PLAN.
I'LL DISCUSS EXAMPLES OF NIAMS
INITIATIVES IN MUSCULOSKELETAL
PAIN, MANY CONDUCTED IN
PARTNERSHIP WITH OTHER
INSTITUTES AND CENTERS INCLUDING
NCCIH.
SO THE INSTITUTE WAS ESTABLISHED
IN 1986 BUT PREVIOUSLY PART OF
THE NATIONAL INSTITUTE OF
ARTHRITIS, DIABETES, DIGESTIVE
AND KIDNEY DISEASES, NOW
NATIONAL INSTITUTE OF DIABETES
AND DIGESTIVE AND KIDNEY
DISEASES, QUITE A MOUTHFUL.
AND MISSION OF NIAMS AS DR.
LANGEVIN WAS REFERRING TO
SUPPORT AN CONDUCT RESEARCH INTO
TREATMENT AND PREVENTION, TO
TRAIN THE NEXT GENERATION OF
SCIENTISTS TO CARRY OUT THIS
RESEARCH, AND PROVIDE
INFORMATION TO THE PUBLIC ABOUT
OUR RESEARCH PROGRESS AND
MISSION AREAS AND HOW IT CAN BE
APPLIED TO IMPROVE HEALTH.
IN 2020 NIAMS BUDGET WAS $624
MILLION, SUPPORTING INTRAMURAL
PROGRAM AND EXTRAMURAL RESEARCH
THAT'S CONDUCTED AT INSTITUTIONS
AROUND THE COUNTRY.
WITH RESPECT TO THE BUDGET, THIS
SLIDE SHOWS THE BREAKDOWN OF
FISCAL YEAR 2020 FUNDING AMONG
INTRAMURAL, EXTRAMURAL, AND
OTHER COMPONENTS OF THE NIH AND
NIAMS.
LIKE THE REST OF NIH, NIAMS
INVESTS MOST MONEY AT
INSTITUTIONS AROUND THE COUNTRY,
10 1/2% TO INTRAMURAL RESEARCH
PROGRAM IN BETHESDA.
THE SLIGHT OF RMS, RESEARCH AND
MANAGEMENT SUPPORT, IS FOR WHAT
OTHER ORGANIZATIONS CALL
OVERHEAD.
WITH INPUT FROM NIAMS ADVISORY
COUNCIL AND THE PUBLIC, NIAMS
DEVELOPED CURRENT STRATEGIC PLAN
COVERING FISCAL YEARS 2020-2024.
THE ULTIMATE GOAL TO DEVELOP
PATIENT-CENTERED PERSONALIZED
WAYS TO IMPROVE HEALTH OUTCOMES
IN THE FIVE CORE AREAS OF THE
NIAMS MISSION.
THESE INCLUDE SYSTEMIC RHEUMATIC
AND AUTOIMMUNE DISEASE, SKIN
BIOLOGY AND DISEASES, BONE
BIOLOGY AND DISEASES, MUSCLE
BIOLOGY AND DISEASES, AND JOINT
BIOLOGY, DISEASES, ORTHOPEDICS.
THE PLAN INCLUDES DEDICATED
SESSION FOR EACH OF THESE AREAS
INCLUDING BROAD RESEARCH
DIRECTIONS FOR TOPICS IN EACH OF
THE PORTFOLIOS.
IN LOOKING AT THE AREAS WITHIN
THE NIAMS PURVIEW I WANT TO
UNDERSCORE TREMENDOUS BURDEN OF
THESE DISEASES.
ARTHRITIS AND MUSCULOSKELETAL
AFFECT PEOPLE OF ALL AGES AND
RACIAL AND ETHNIC BACKGROUNDS.
COMBINED THEY AFFECT TENS OF
MILLIONS OF AMERICANS, CAUSE
TREMENDOUS HUMAN SUFFERING,
AFFECT U.S. ECONOMY DUE TO
TREMENDOUS HEALTH CARE COSTS AND
LOSS OF PRODUCTIVITY.
MOST OF THE DISEASES COVERED BY
NIAMS ARE CHRONIC, AND MANY ALSO
ASSOCIATED WITH CHRONIC PAIN AND
DISABILITY.
MANY OF THEM WHETHER COMMON OR
RARE AFFECT WOMEN AND MINORITIES
DISPROPORTIONATELY.
THE CURRENT NIAMS STRATEGIC PLAN
IN ADDITION TO INCLUSION
INFORMATION SPECIFIC TO CORE
MISSION AREA ALSO HIGHLIGHTS
SEVERAL SCIENTIFIC THEMES THAT
CUT ACROSS ALL AREAS OF OUR
MISSION.
INCLUDING OUR EFFORTS RELATED TO
MUSCULOSKELETAL PAIN RESEARCH,
IDENTIFYING SHARED MECHANISMS IN
HEALTH AND AMONG DISEASES,
ADVANCING PATIENT CENTERED
APPROACHES, ADDRESSING HEALTH
NEEDS OF DIVERSE POPULATIONS,
ENABLING PRECISION MEDICINE TO
TAILOR CARE FOR EACH PATIENT.
BEFORE I DISCUSS NIAMS CURRENT
ACTIVITIES I WANT TO HIGHLIGHT A
SUCCESSFUL PAST COLLABORATION
BETWEEN NIAMS AND NCCIH.
IN 2004, NIAMS AND NCCIH LED A
TRANS-NIH-WIDE EFFORT TO DEVELOP
PATIENT-REPORTED OUTCOMES AND
MEASUREMENTS INFORMATION SYSTEM,
PROMIS, THAT WAS FUNDED THROUGH
NIH COMMON FUND.
WHILE PATIENT-REPORTED OUTCOMES
ARE WIDELY USED TODAY WHEN THE
PROGRAM BEGAN IN 2004 THERE WAS
A NEED FOR TOOLS TO ASSESS
PATIENT CENTERED OUTCOMES SUCH
AS PAIN IN CLINICAL RESEARCH.
TODAY PROMIS IS A RICH RESOURCE
FOR RESEARCHERS, CLINICIANS,
PATIENTS.
IT HAS APPROXIMATELY 70 DOMAINS
MEASURING PAIN, FATIGUE,
DEPRESSION, ANXIETY, SLEEP
DISTURBANCE, PHYSICAL FUNCTION,
AMONG OTHERS.
PROMIS IS VERY INCLUSIVE,
ENCOMPASSES CHILDREN AND ADULTS,
CAN BE ADMINISTERED TO A WIDE
RANGE OF INDIVIDUALS REGARDLESS
OF LITERACY, LANGUAGE, PHYSICAL
FUNCTION, LIFE COURSE.
THIS PARTNERSHIP IS ENHANCING
RESEARCH LANDSCAPE TO BRING
VOICES TO CLINICAL CARE AND
RESEARCH WITH THE GOAL OF
IMPROVING DAY TO DAY LIVES OF
PEOPLE.
NEXT I WANT TO DISCUSS SOME OF
NIAMS CURRENT ACTIVITIES TO
ADDRESS MUSCULOSKELETAL PAIN
BEGINNING WITH OAI, AN EXAMPLE
OF SIGNIFICANT EFFORTS IN
EXPLORING CLINICAL ASPECTS OF
OSTEOARTHRITIS AND REPRESENTS A
LONG-TERM INVESTMENT IN THE
FIELD.
THE INITIATIVE HAS BEEN CARRIED
OUT IN PARTNERSHIP WITH SEVERAL
NIH INSTITUTES AND CENTERS
INCLUDING NCCIH, FOUNDATION FOR
NIH, INDUSTRY.
STUDIED 4800 PARTICIPANTS FROM
45 TO 79.
58% WERE FEMALE.
PARTICIPANT VISITS THROUGH EIGHT
YEARS OF FOLLOW-UP COMPLETED
MAKES THE OAI ONE OF THE LARGEST
AND PERHAPS MOST IMPORTANT
DATASETS IN THE HISTORY OF
OSTEOARTHRITIS RESEARCH.
THE DATASET CONTAINS CLINICAL,
GENOMIC, PATIENT-REPORT AND
FUNCTIONAL DATA, BIOLOGICAL
SPECIMENS, X-RAY AND MAGNETIC
RESONANCE IMAGES.
THE DATA ARE FREELY AVAILABLE AT
OAI.NIH.GOV.
RESEARCHERS CAN ACCESS THE
STUDIES OF NATURAL HISTORY,
BIOMARKERS, RISK FACTORS FOR
O.A. RISK AND PROGRESSION.
DATA ARE ALSO RESOURCED FOR
INVESTIGATORS FOR COMPUTATIONAL
MACHINE LEARNING EXPERTISE IN
OTHER FIELDS TO APPLY BIG DATA
THOUGHTS TO A BIOMEDICAL
RESEARCH PROGRAM.
TO DATE MORE THAN 680
PEER-REVIEWED PAPERS HAVE BEEN
PUBLISHED USING OAI DATA.
OVER ALL THE OAI HAS TAUGHT US
KNEE O.A. INVOLVES ALL THE
STRUCTURES THAT FORM THE JOINT.
THIS SLIDE PROVIDES EXAMPLES OF
RESEARCH ADVANCES FROM THE OAI
RELATED TO PHYSICAL ACTIVITY AND
DIET.
THE STUDY HAS BEEN PROVIDED
VALUABLE INFORMATION ABOUT
POTENTIALLY MODIFIABLE RISK
FACTORS FOR OSTEOARTHRITIS.
THESE FINDINGS HAVE IMPORTANT
PUBLIC HEALTH PRELIMINARY
INDICATIONS.
FOR EXAMPLE WE HAVE EVIDENCE
EXERCISE IS SAFE AND BENEFICIAL
FOR INDIVIDUALS WITH O.A.
BEYOND OAI, OTHER NIAMS-FUNDED
STUDIES DOCUMENTED THAT WEIGHT
LOSS AND EXERCISE CAN IMPROVE
KNEE O.A. SYMPTOMS.
AS I NOTED IN MY INTRODUCTION,
HEALTH DISPARITIES ARE SEEN IN
MANY OF THE DISEASES WITHIN OUR
MISSION, INCLUDING
OSTEOARTHRITIS.
THIS IS A SIGNIFICANT PUBLIC
HEALTH CHALLENGE SINCE O.A. IS
THE MOST COMMON TYPE OF
ARTHRITIS LEADING TO DISABILITY.
NIAMS IS PLANNING A WORKSHOP ON
HEALTH DISPARITIES AND O.A.,
AJERCH -- THE AGENDA ON THE
SLIDE, TIMELY CONSIDERING
PRIORITIES REGARDING HEALTH
DISPARITIES.
THE WORKSHOP WILL BRING TOGETHER
O.A. INVESTIGATORS WITH EXPERTS
IN HEALTH DISPARITIES RESEARCH
TO EXCHANGE IDEAS ABOUT WIDE
DISPARITIES IN TREATMENT
OUTCOMES AND ACCESS TO CARE
EXIST AND HOW THEY CAN BE
ADDRESSED.
PARTICIPANTS WILL CONSIDER HOW
INTEGRATION OF BEHAVIORAL AND
BIOMEDICAL SCIENCE COULD LEAD TO
BETTER HEALTH IN O.A.
NEXT I WANT TO TALK ABOUT THE
NIAMS-FUNDED METEOR TRIAL.
MENISCAL TEAR, WHEN THE DISC IS
DAMAGED, OCCURS FREQUENTLY AMONG
INDIVIDUALS WITH KNEE
OSTEOARTHRITIS.
PATIENTS HAVE TWO OPTIONS FOR
TREATMENT.
ARTHROSCOPIC PARTIAL MENISECTOMY
AND STABILIZING, OR PHYSICAL
THERAPY.
IN METEOR, RESEARCHERS COMPARED
SURGERY WITH PHYSICAL THERAPY,
TO DETERMINE IF ONE TREATMENT
LED TO BETTER OUTCOMES THAN THE
OTHER.
THEY RECRUITED APPROXIMATELY 350
MEN AND WOMEN, AGES 45 AND
OLDER, WITH MILD TO MODERATE
KNEE O.A. AND MENISCAL TEAR.
PATIENTS WERE RANDOMLY ASSIGNED
TO RECEIVE SURGERY AND PHYSICAL
THERAPY OR PHYSICAL THERAPY
ALONE.
PATIENTS ASSIGNED TO PHYSICAL
THERAPY HAD THE OPTION OF
UNDERGOING SURGERY LATER IN THE
TRIAL.
THE RESEARCHERS ASSESSED EACH
PATIENT'S PROGRESS OVER ONE
YEAR, TRACKING IMPROVEMENTS IN
FUNCTIONAL STATUS AND PAIN
LEVELS.
INITIALLY, THERE WAS GREATER
IMPROVEMENT IN THOSE WITH
SURGERY.
THOSE IN THE PHYSICAL THERAPY
THROUGH 12 CONTINUES IMPROVEMENT
SHOWED IMPROVEMENT COMPARABLE TO
SURGERY.
IT'S OKAY TO TRY PHYSICAL
THERAPY FIRST IF A PATIENT
PREFERS.
A THIRD OF PATIENTS ASSIGNED TO
PHYSICAL THERAPY ALONE UNDERWENT
SURGERY WITHIN SIX MONTHS,
INDICATING PHYSICAL THERAPY IS
NOT THE ANSWER FOR SOME
PATIENTS.
THE ORIGINAL METEOR STUDY DID
NOT ADDRESS IMPORTANT ISSUE OF
LONG-TERM OUTCOMES OF SURGERY
VERSUS PHYSICAL THERAPY.
PRELIMINARY DATA FROM METEOR
SUGGESTED SURGERY WITH RAPID
PROGRESSION AS ASSESSED THROUGH
MRI THROUGH FIVE YEARS,
RESEARCHERS ARE NOW CONDUCTING A
12-YEAR FOLLOW-UP STUDY TO
DETERMINE WHETHER THIS MORE
RAPID STRUCTURAL PROGRESSION
CONTINUES TO BE SEEN OVER LONGER
TIME PERIOD.
THE RESEARCHERS HOPE TO
UNDERSTAND CLINICAL
IMPLICATIONS.
ASSUMPTION THAT FASTER
PROGRESSION ON MRI RESULTS IN
MORE PAIN, MORE EVIDENCE IS
NEEDED TO KNOW WHETHER THIS IS
THE CASE.
WE EXPECT THIS RESEARCH WILL
PROVIDE IMPORTANT NEW
INFORMATION FOR CLINICIANS AND
PATIENTS TO UNDERSTAND RISKS AND
BENEFITS OF SURGERY VERSUS
NON-OPERATIVE TREATMENT.
NEXT I'LL TALK ABOUT A COUPLE
NIAMS RESEARCH ACTIVITIES
RELATED TO FIBROMYALGIA, WHERE
PAIN AND INCREASED PAIN
SENSITIVITY ARE KEY FEATURES.
IT IS MORE OFTEN DIAGNOSED IN
WOMEN BUT CAN OCCUR IN CHILDREN,
YOU'VE NIGHT ONSET FIBROMYALGIA,
A PAINFUL CONDITION PERSISTING
INTO ADULTHOOD FOR MANY
PATIENTS.
BUILDING ON PREVIOUS RESEARCH
SHOWING CBT BENEFITS ADOLESCENTS
WITH FIBROMYALGIA, THE
NIAMS-FUNDED FIBROMYALGIA
INTEGRATIVE TRAINING PROGRAM FOR
TEENS, FIT TEENS, IS A CLINICAL
TRIAL TESTING WHETHER ADDING
PHYSICAL ACTIVITY TO CBT
CONIFERS ADDITIONAL BENEFIT IN
TERMS OF MANAGING PAIN IN
ADOLESCENCE, SUPPLEMENTING WITH
NEUROMUSCULAR TRAINING EXERCISES
DERIVED FROM PEDIATRIC INJURY
PREVENTION RESEARCH.
PILOT DATA SUGGESTED FIT TEENS
INTERVENTION OFFERINGS STRONGER
TREATMENT BENEFITS THAN CBT
ALONE WITH RESPECT TO PAIN
REDUCTION, RESULTS REMAIN TO BE
CONFIRMED IN A LARGER STUDY.
NIAMS IS INVESTING IN
FIBROMYALGIA RESEARCH THROUGH
CENTERS OF RESEARCH TRANSLATION
PROGRAM, TEAM SCIENCE PERHAPS
ARE DESIGNED TO ADDRESS
TRANSLATIONAL CHALLENGES.
NIAMS-SUPPORTED CORE AT THE
UNIVERSITY OF MICHIGAN SEEKS TO
IMPROVE UNDERSTANDING TO
TREATMENTS FOR PAIN SUCH AS
SURGERY OR MEDICATIONS.
THIS IS IMPORTANT BECAUSE
INDIVIDUAL RESPONSES TO
TREATMENTS FOR PAIN ARE HIGHLY
VARIABLE.
NO MATTER HOW SUCCESSFUL THE
TREATMENT MAY APPEAR TO BE BY
CLINICAL MEASURES.
FOR EXAMPLE, MANY INDIVIDUALS
WITH CHRONIC PAIN WHO UNDERGO
SURGERY FOR THE PROBLEM CONTINUE
TO EXPERIENCE PAIN DESPITE WHAT
MAY BE CONSIDERED EXCELLENT
RESULTS FROM A CLINICAL
STANDPOINT.
JUST AS SOME WITH AUTOIMMUNE
DISORDERS CONTINUE TO HAVE PAIN
AFTER INFLAMMATION IS WELL
CONTROLLED WITH BIOLOGICS OR
OTHER TREATMENT.
THE RESEARCHERS WILL DETERMINE
IF THIS VARIABILITY CAN BE
QUANTIFIED OR PREDICTED USING
FIBROMYALGIA PAIN SCALE AS A
SURROGATE MEASURE.
HIGHER SCORES COULD PREDICT MORE
PAIN FROM THE CENTRAL NERVOUS
SYSTEM.
THEY ARE EXPLORING WHETHER THE
PHENOTYPE HAS CLINICAL AND
NEUROBIOLOGICAL FEATURES SIMILAR
TO FIBROMYALGIA EVEN WHEN
COMORBID WITH OTHER
MUSCULOSKELETAL PAIN CONDITIONS
WITH DIFFERENT PAIN MECHANISMS.
BY BETTER UNDERSTANDING
UNDERLYING MECHANISMS ASSOCIATED
WITH PAIN FOR SEVERAL
CONDITIONS, THIS RESEARCH PLAY
ENABLE A MORE PERSONALIZED
APPROACH TO PAIN MANAGEMENT FOR
PATIENTS.
NEXT I WANT TO TALK ABOUT
"HEAL."
IT'S A TRANSAGENCY EFFORT TO
SPEED SOLUTIONS TO STEM THE
NATIONAL OPIOID PUBLIC HEALTH
CRISIS.
IT'S FUNDING HUNDREDS OF
PROJECTS ACROSS THE NATION,
RESEARCHERS ARE TAKING A VARIETY
OF APPROACHES TO TACKLE OPIOID
EPIDEMIC THROUGH UNDERSTANDING,
MANAGING, TREATING PAIN AND
IMPROVING TREATMENT FOR OPIOID
MISUSE AND ADDICTION.
ALMOST EVERY NIH INSTITUTE AND
CENTER IS PARTICIPATING IN
"HEAL."
ONE OF THE WAYS NIAMS IS
CONTRIBUTING IS LEADING BACK
PAIN CONSORTIUM RESEARCH
PROGRAM, BACPAC.
CHRONIC LOW BACK PAIN IS ONE OF
THE MOST COMMON FORMS OF CHRONIC
PAIN AMONG ADULTS WORLDWIDE.
ACCORDING TO THE 2010 GLOBAL
BURDEN OF DISEASE STUDY, IT
RANKED HIGHEST IN TERMS OF YEARS
LIVED WITH DISABILITY AMONG
HUNDREDS OF CONDITIONS.
CURRENTS TREATMENT OPTIONS ARE
INEFFECTIVE LEADING TO INCREASED
USE OF OPIOIDS.
BACPAC IS A TRANSLATIONAL
PATIENT-CENTERED RESEARCH EFFORT
TO DEVELOP EFFECTIVE,
PERSONALIZED TREATMENTS FOR
CHRONIC LOW BACK PAIN.
THROUGH BACPAC, INVESTIGATORS
ARE USING DEEP PHENOTYPING TO
CHARACTERIZE PEOPLE WITH CHRONIC
LOW BACK PAIN TO IMPROVE
UNDERSTANDING OF THE COMPLEX
MECHANISMS UNDERLYING THE
CONDITION, IDENTIFYING PATHWAYS
AND TARGETS FOR INTERVENTION, TO
INFORM DEVELOPMENT OF THERAPIES
THAT REDUCE PAIN AND IMPROVE
FUNCTION, DEVELOPING PRECISE
DIAGNOSTIC AND TREATMENT
ALGORITHMS, AND THEN TESTING AND
REFINING THEM IN CLINICAL TRIALS
SO THAT HEALTH CARE PROVIDERS
CAN TAILOR THERAPIES TO
PATIENTS, COMBINING DATA FROM
TRANSLATIONAL RESEARCH, PHASED
CLINICAL TRIALS TO DELIVER
INTEGRATIVE MODEL TO PACK BANE
AND COLLABORATING WITH "HEAL"'S
EARLY PHASE PAIN INVESTIGATION
CLINICAL NETWORK, EPPIC NET, TO
TEST POTENTIAL CHRONIC LOW BACK
PAIN INTERVENTIONS IN CLINICAL
TRIALS.
THIS SLIDE PROVIDES ADDITIONAL
INFORMATION ABOUT THE COMPONENTS
OF BACPAC AND INVESTIGATORS
LEADING THE VARIOUS EFFORTS.
THE MECHANISTIC AND RESEARCH
CENTERS ARE COLLECTING PATIENT
DATA TO IDENTIFY SPECIFIC TRAITS
UNIQUE TO CHRONIC LOW BACK PAIN
PATIENTS, AND IDENTIFY NEW
THERAPIES.
THE TECHNOLOGY SITES CREATE,
TEST, AND DISTRIBUTE TECHNOLOGY
AND METHODS TO TEST, QUANTIFY
AND RELIEVE CHRONIC LOWER BACK
PAIN.
PHASE 2 CLINICAL STUDIES ASSESS
SAFETY AND VALUE OF ALTERNATIVE
MEDICINE, NON-ADDICTIVE DRUGS,
DEVICES THAT RELIEVE CHRONIC LOW
BACK PAIN AND HELP PATIENT CARRY
OUT ACTIVITIES OF DAILY LIVING.
THE NEW THERAPIES UNDER STUDY
USE BIOLOGY, PSYCHOLOGY,
INFORMATION ON SOCIAL FACTORS
CONNECTED TO CHRONIC LOWER BACK
PAIN.
AND THE DATA INTEGRATION
ALGORITHM DEVELOPMENT AND
OPERATION CENTER COORDINATES
BACPAC ACTIVITIES.
A CONSORTIUM-WIDE CLINICAL TRIAL
CALLED BIOMARKERS FOR EVALUATING
SPINE TREATMENTS, BEST, IS
DESIGNED TO INFORM PRECISION
MEDICINE APPROACH TO CHRONIC LOW
BACK PAIN.
IT IS INVESTIGATING MIND-BODY
INTERVENTIONS, NOT POWERED BASED
ON ASSESSING EFFICACY OF ONE
VERSUS ANOTHER INTERVENTION BUT
SEEKS TO LINK A PATIENT'S
PHENOTYPE TO INTERVENTION THAT
WORKS BEST FOR THAT INDIVIDUAL.
USING DATA FROM THE BACPAC
RESEARCH PROGRAMS CLINICAL
STUDIES, THE DATA CENTER WILL
ALSO DEVELOP PATIENT-CENTERED
ALGORITHMS TO IMPROVE
THERAPEUTIC INTERVENTIONS AND
PROVIDE INTEGRATED MODEL OF
CHRONIC LOW BACK PAIN.
WE BEGAN WITH INITIAL MODEL
BASED ON CURRENT STATE OF
KNOWLEDGE.
AS YOU CAN SEE, MODEL IS FOCUSED
ON TAKING INTEGRATIVE APPROACH
THAT ENCOMPASSES BIOLOGICAL,
BIOMECHANICAL, PSYCHOSOCIAL AND
OTHER PROCESSES.
THROUGH BACPAC WE WILL
INTERROGATE IMPLIED
R ELATIONSHIPS IN ITERATIVE
FASHION, REVISE USING DATA
GENERATED OR AVAILABLE TO
BACPAC.
WE'RE DELIGHTED TO BE ABLE TO
PLAY AN IMPORTANT ROLE IN
ADDRESSING THE PROBLEM OF
CHRONIC LOW BACK PAIN WHILE
WORKING WITH PARTNERS INCLUDING
NCCIH ON THIS TRANS-NIH EFFORT
TO ADDRESS THE NATION'S OPIOID
EPIDEMIC.
IN ADDITION TO PACKBACK, NIAMS
ALSO WORKED WITH SEVERAL
INSTITUTES AND CENTERS ON A NEW
HEAL INITIATIVE, RESTORING JOINT
AND FUNCTION TO REDUCE PAIN
CONSORTIUM, RE-JOIN.
THE FUNDING OPPORTUNITY
ANNOUNCEMENTS WERE RELEASED LAST
WEEK.
SINCE DR. LANGEVIN WILL BE
DISCUSSING THIS PROGRAM LATER
THIS AFTERNOON, I'LL JUST
BRIEFLY NOTE THE GOAL IS TO
DEFINE INNERVATION OF DIFFERENT
TISSUES THAT FORM THE JOINT.
IN ADDITION TO BACPAC AND
RE-JOIN, NIAMS IS PARTNERING
WITH SEVERAL I.C.s ON OTHER
HEAL INITIATIVES.
THIS COUNCIL IS LIKELY FAMILIAR
WITH THE NCCIH-LED INITIATIVE
DEVELOPING QUANTITATIVE IMAGING
AND OTHER RELEVANT BIOMARKERS
AND MYOFASCIAL TISSUES FOR
CLINICAL PAIN MANAGEMENT, AND
NIAMS IS PLEASED TO BE PARTNER
IN THIS EFFORT WHICH SEEKS TO
IMPROVE MONITORING OF RESPONSES
AND PREDICTION OF OUTCOMES OF
VARIOUS PAIN MANAGEMENT
REGIMENS.
WE ARE ALSO INVOLVED IN A
NIDA-LED INITIATIVE FOR BEST
MODELS OF CARE AS WELL AS
IMPROVE ACCESS TO QUALITY CARE
FOR PATIENTS WITH CHRONIC PAIN
AND OPIOID USE DISORDER, OPIOID
MISUSE.
NIAMS CONTRIBUTED TO NCCIH--LED
WORKSHOP IN 2020.
THREE PROJECTS RELATED TO NIAMS
MISSION AREAS OF ACUPUNCTURE IN
CHRONIC LOW BACK PAIN,
MINDFULNESS FOR CHRONIC LOW BACK
PAIN, AND PHYSICAL THERAPY ARE
SUPPORTED AS PART OF THE "HEAL"
PRISM EFFORT, FOR MANAGEMENT OF
PAIN TO REDUCE OPIOID
PRESCRIBING.
NIAMS AND NCCIH PARTNERED ON A
LARGE PRAGMATIC CLUSTER
RANDOMIZED CONTROLLED TRIAL
TESTING EFFECTIVENESS OF A
SIMPLE AND INEXPENSIVE
INTERVENTION.
INSERTING EPIDEMIOLOGIC
BENCHMARKS INTO LUMBAR SPINE
IMAGING REPORTS.
THE GOAL WAS TO TEST WHETHER THE
ADDITION OF SUCH DATA REDUCED
SUBSEQUENT TESTS AND TREATMENTS
INCLUDING CROSS-SECTIONAL
IMAGING, SUCH AS MAGNETIC
RESONANCE AND COMPUTED
TOMOGRAPHY, OPIOID PRESCRIPTION,
SPINAL INJECTION, OR SURGERY.
LAST YEAR THE INVESTIGATORS
CONCLUDED THAT INSERTING
EPIDEMIOLOGIC TEXT HAD NO EFFECT
ON WHETHER NEW NON-OPIOID
PAIN-RELATED MEDICATIONS WERE
PRESCRIBED OVERALL, BUT WAS
ASSOCIATED WITH NUMBER OF NEW
PRESCRIPTIONS FOR CERTAIN
NON-OPIOID SUBCLASSES SUCH AS
NSAIDs AND TRICYCLIC
ANTIDEPRESSANTS.
NOW I'LL TURN TO SOME OF OUR
EFFORTS RELATED TO CONDITIONS
WITHIN OUR SYSTEMIC RHEUMATIC
DISEASES PORTFOLIO, MANY ARE
ALSO CHARACTERIZED BY
MUSCULOSKELETAL PAIN.
ONE OF THE INITIAL PROJECTS
LAUNCHED BY THE NIH ACCELERATING
MEDICINES PARTNERSHIP PROGRAM,
AMP, WAS IN RHEUMATOID ARTHRITIS
AND LUPUS.
I WANT TO DISCUSS THE PROGRAM
AND TELL YOU ABOUT THE NEXT
ITERATION WHICH WE EXPECT TO BE
FUNDED SOON.
IN 2014, NIAMS AND NIAID WITH
ORGANIZATIONS LAUNCHED AMP-RA
LUPUS PROGRAM TO TRANSFORM THE
MODEL FOR DEVELOPING DIAGNOSTICS
AND TREATMENTS FOR THESE
CONDITIONS.
THE PROJECT WAS EXTREMELY
INNOVATIVE IN THAT IT INVOLVED
ISOLATION OF SINGLE CELLS FROM
TISSUES, SITES OF DISEASE FOR
ANALYSIS, SURPASSING
EXPECTATIONS BY IDENTIFYING CELL
TYPES AND PATHWAYS NOT
IDENTIFIED BEFORE IN THESE
CONDITIONS AND ADVANCING NEW
ANALYTIC APPROACHES FOR STUDYING
DISEASE IN HUMAN TISSUES.
ONE OF THE MOST IMPORTANT
LEGACIES OF THE PROGRAM IS THE
RICH DATASET IT GENERATE AND
MADE AVAILABLE TO THE RESEARCH
COMMUNITY.
WE ENVISION THE PROGRAM WILL
BENEFIT RESEARCH ON RA LUPUS
INCLUDING RESEARCH SUPPORTED BY
NCCIH.
FOR EXAMPLE, THE DATA MAY BE
USEFUL FOR RESEARCHERS EXPLORING
POTENTIAL OF NATURAL PRODUCTS
WITH PROPOSED ANTI-INFLAMMATORY
PROPERTIES IN MUSCULOSKELETAL
AND INFLAMMATORY CONDITIONS.
IN ADDITION, BIOMARKERS ARE NOT
A MAJOR FOCUS OF THE AMP, ANY
NEW BIOMARKERS THAT DO RESULT
COULD BE USED TO ENHANCED DESIGN
OF CLINICAL TRIALS AND CLINICAL
STUDIES THAT TEST COMPLEMENTARY
INTERVENTIONS IN TERMS OF BETTER
OUTCOME MEASURES AND PATIENT
STRATIFICATION.
WHEREAS AMP RA-LUPUS IDENTIFIED
CELL POPULATIONS AND EFFECTOR
PATHWAYS THAT CAN BE USED AS
BIOMARKERS, THERAPEUTIC TARGETS
OR BENCHMARKS FOR MOLECULAR
CLASSIFICATION OF DISEASE, THE
NEXT PHASE CALLED AMP AIM FOR
AUTOIMMUNE AND IMMUNE-MEDIATED
DISEASE, WILL PUT THESE PIECES
BACK TOGETHER, TO DISCOVER HOW
CELLS OF THE INNATE AND ADAPTIVE
IMMUNE SYSTEM AND TISSUE
RESIDENT CELLS INTERACT TO CAUSE
INFLAMMATION AND DISEASE AND TO
ACCELERATE DISCOVERY OF DISEASE
MECHANISMS IN THERAPEUTIC
TARGETS.
AS THE NAME IMPLIES, AMP AIM
EXTENDS BEYOND RHEUMATOID
ARTHRITIS AND LUPUS.
REQUEST FOR APPLICATIONS
INCLUDED PSORIASIS, PSORIATIC
ARTHRITIS AND SHÖGREN'S SYSTEM.
WE EXPECT TO USE AN ANALYTICS
TO HELP IDENTIFY SPECIFIC AND
SHARED DISEASE MECHANISMS.
ULTIMATELY WE OPEN IT WILL
PROVIDE A ROAD MAP HOW TO APPLY
TECHNOLOGY TO STUDY DISEASE
TISSUES.
WE EXPECT THE PROJECT TO RESULT
IN KNOWLEDGE AND DATA PORTAL TO
ENABLE DATA SHARING AND MAKE
DATA AND ANALYTIC TOOLS
ACCESSIBLE TO ALL STAKEHOLDERS.
WE HOPE WHAT WE LEARNED FROM AMP
AIM WILL HELP TO ADVANCE
INTEGRATEIVE APPROACHES TO
PATHOPHYSIOLOGY AND TREATMENTS
IN OF DISEASES BEING STUDIES.
WE'VE REVIEWED APPLICATIONS AND
EXPECT TO ANNOUNCE THE AWARDS IN
THE COMING WEEKS.
NOW THAT I'VE SHARED INFORMATION
ABOUT OUR CURRENT ACTIVITIES I
WANT TO BRIEFLY COVER OUR BUDGET
OUTLOOK AND FUTURE PLANS.
AS YOU KNOW, THE NEW FISCAL YEAR
FOR THE FEDERAL GOVERNMENT BEGAN
ON OCTOBER 1.
THE PRESIDENT AND BOTH CHAMBERS
OF CONGRESS PROPOSED BUDGETS FOR
THE NIH AND NIAMS, THE CONGRESS
HAS NOT YET REACHED AN AGREEMENT
ON THE FINAL NUMBERS.
WE'RE CURRENTLY OPERATING UNDER
CONTINUING RESOLUTION THROUGH
FEBRUARY 18.
WE DON'T KNOW WHAT THE FINAL
BUDGETS FOR 2022 LOOK LIKE WE'RE
ENCOURAGING BY FUNDING LEVELS IN
THE PROPOSALS.
AMONG THE PROPOSALS IS INCREASE
FOR "HEAL," BUDGET PROPOSALS
ALSO INCREASE ADDITIONAL $24
MILLION TO ENHANCE NIAMS PAIN
AND OPIOID AND RESEARCH
PORTFOLIO, TO INVEST MONEY
SHOULD IT BE INCLUDED.
RELATED WE PUBLISHED A NOTICE OF
SPECIAL INTEREST TO HIGHLIGHT
INTEREST IN PROMOTING RESEARCH
ON PAIN.
WE'RE OPTIMISTIC AND EXPECT THEY
WILL BENEFIT INDIVIDUALS AND
FAMILIES LIVING BY AND IMPACTED
BY MUSCULOSKELETAL PAIN.
I LEAVE YOU WITH RESOURCES TO
LEARN MORE ABOUT NIAMS.
IF YOU'RE INTERESTED IN LEARNING
MORE ABOUT OUR PROGRAMS, VISIT
THE NIAMS WEBSITE.
YOU CAN FIND US ON FACEBOOK,
YouTube.
TO LEARN MORE ABOUT OUR FUNDING
OPPORTUNITY ANNOUNCEMENTS AS
WELL AS NOTICES ANNOUNCING
SPECIAL INTERESTS, SUBSCRIBE TO
THE NEWSLETTER AND FOLLOW OUR
TWITTER ACCOUNT.
ONCE AGAIN, I THANK YOU VERY
MUCH FOR THE OPPORTUNITY TO
PRESENT TO THIS COUNCIL AND
WOULD BE HAPPY TO TAKE QUESTIONS
AT THIS TIME. .
>> THANK YOU, DR. CRISWELL.
WE'RE NOW OPEN FOR EXTENDED
QUESTIONS, QUESTIONS AND ANSWERS
AND DISCUSSIONS FOR ANYTHING
BETWEEN COUNCIL AND DR. CHRIS
WELL.
RAISE YOUR DIGITAL HAND.
I WILL CALL ON YOU IN THE ORDER
YOU RAISE YOUR HANDS.
DR. LANGEVIN, DID YOU WANT TO
MAKE OPENING REMARKS?
>> YES.
I WOULD VERY MUCH LIKE TO.
I WANT TO REALLY THANK YOU FOR
THIS WONDERFUL OVERVIEW OF ALL
OF THE INTEREST, THE BROAD
INTEREST OF NIAMS, BUT I'M
STRUCK BY THE AREAS OF NOT ONLY
HISTORICAL COLLABORATIONS THAT
WE'VE HAD BETWEEN NCCIH AND
NIAMS BUT THE POTENTIAL FOR THE
FUTURE.
THIS IS VERY EXCITING AND I LOOK
FORWARD TO HEARING ANY REACTIONS
FROM OUR COUNCIL ABOUT WHAT THEY
FIND INTERESTING IN HERE AND
WHAT THEY SEE.
>> I WAS ALSO REALLY STRUCK BY
THE TREMENDOUS OVERLAP AND LONG
HISTORY OF OUR COLLABORATIONS IN
PREPARING THESE REMARKS.
SO REALLY MANY, MANY
OPPORTUNITIES MOVING FORWARD,
VERY EXCITED ABOUT THAT.
>> ABSOLUTELY.
>> DR. DELEDO AND DR. HARRIS.
>> I'LL BE VERY SHORT.
A PERSON WHO STRADDLED NIAMS AND
NCCIH, NONE OF THIS IS NEWS FOR
ME.
THERE'S ALWAYS BEEN OVERLAP AND
I'VE BEEN PLEASED WITH HOW
THERE'S JUST SO MUCH
COLLABORATION ALREADY.
I THINK THERE'S POTENTIAL FOR A
GREAT DEAL MORE.
>> THANK YOU.
>> DR. HARRIS?
>> THANK YOU VERY MUCH, DR.
CRISWELL, FOR YOUR PRESENTATION.
AND VERY EXCITED ABOUT THE
POTENTIALS.
I WONDER IF THERE'S A WAY TO
STRENGTHEN THE PARTNERING
BETWEEN NIAMS AND NCCIH TO HAVE
SPECIFIC FUNDING OPPORTUNITIES
THAT BRIDGE BOTH, YOU KNOW,
INTEGRATIVE MEDICINE APPROACHES
THAT MANY PATIENTS ARE TRYING
AND MORE CONVENTIONAL APPROACHES
WHICH MAY BE MUCH MORE EASILY
ACCESSIBLE TO PATIENTS, AND I'M
WONDERING IF THERE MIGHT BE ANY
OPPORTUNITIES TO STRENGTHEN THE
BRIDGE WHERE THERE'S SPECIFIC
RFAs OR SPECIFIC ITEMS FOR
FUNDING THAT BRIDGE THAT
TRANSLATIONAL GAP.
BECAUSE MANY TIMES IN HEALTH
CARE SETTINGS, IT'S SILOED.
LIKE YOU EITHER GET INTEGRATEIVE
APPROACH FOR CONVENTIONAL
APPROACH AND MANY TIMES YOU
DON'T GET SYNERGY BETWEEN THOSE,
ALTHOUGH THERE ARE SOME PATIENTS
THAT ARE FORTUNATE ENOUGH TO GET
THAT.
I'M WONDERING IF THERE'S ANY
FUNDING TO SEEK THAT SYNERGY.
>> FIRST OF ALL, THAT'S A REALLY
INTERESTING COMMENT.
YOU KNOW, MUCH OF THE RESEARCH
OPERATES INDEPENDENTLY IN
PARALLEL IN SILOS AS YOU MENTION
BUT PATIENTS WANT TO ACCESS
ANYTHING THAT MIGHT HELP ACROSS
THE SPECTRUM.
AND IT ISN'T COMMON TO SEE THESE
THINGS BROUGHT TOGETHER.
I'M STILL LEARNING ABOUT ALL OF
THE DIFFERENT WAYS TO PARTNER
WITH INSTITUTES TO FUND
RESEARCH, BUT I'M SURE THAT AT
LEAST FROM A PATIENT STANDPOINT
AND FROM STANDPOINT OF GAPS IN
CURRENT RESEARCH, YOU TOUCHED
UPON A REALLY IMPORTANT AREA
THAT, YOU KNOW, REPRESENTS A
PERFECT PLACE FOR NIAMS AND
NCCIH TO COME TOGETHER.
SO APPRECIATE THAT SUGGESTION
AND SEARCH SOMETHING DR.
LANGEVIN AND I CAN BRAINSTORM
ABOUT MOVING FORWARD.
THANK YOU FOR THAT COMMENT.
>> DR. MALING AND DR. CHERMER.
>> I WANT TO COMMENT I THINK AT
LEAST THREE OF PARTICIPANTS IN
OUR NIH MEETING HERE, ARE PART
OF THE BACPAC, JUST FOR YOUR
INFORMATION.
>> THANK YOU FOR YOUR SUPPORT.
I'M EXCITED TO HEAR ABOUT THE
PROGRAM.
THEY HAVE DONE AN INCREDIBLE JOB
IN MANAGING AND MOVING FORWARD
IN SPITE OF THE CHALLENGES OF
THE PANDEMIC OVER THE COUPLE
YEARS SO THERE'S REALLY A
COMMITTED TEAM WORKING TOGETHER
TO MAKE THAT PROJECT SUCCESSFUL.
>> DR. SHERMAN?
>> YES, THANK YOU FOR TALKING
ABOUT THIS.
I'M A BACK PAIN RESEARCHER AS
WELL.
HAVE DONE MUCH MORE ON THE CIH
END OF THINGS, AND NOW GETTING
INTO SOME IMPLEMENTATION
ASPECTS.
MY DREAM HAS ALWAYS BEEN TO
FIGURE OUT HOW TO TELL A BACK
PAIN PATIENT WHAT THEY SHOULD
TRY RIGHT AWAY THAT HAS A MUCH
GREATER CHANCE OF ACTUALLY
WORKING.
SO, I KNOW THAT THE PHENOTYPING
THAT YOU'RE DOING IN BACPAC IS
STILL MORE IN THE KIND OF
FORMATIVE AND MORE PRELIMINARY
STAGES BUT DO YOU SORT OF SEE A
VISION OF CARRYING THIS ALL THE
WAY THROUGH TO IMPLEMENTATION
AND MIGHT THAT BE ANOTHER AREA
WHERE NCCIH AND NIAMS COULD
PARTNER REALLY WELL?
>> ABSOLUTELY.
WE'RE SO FORTUNATE BACPAC IS
BEING SUPPORTED BY "HEAL" AND
THERE CONTINUES TO BE REALLY
STRONG SUPPORT OF THE "HEAL"
PROGRAM BECAUSE IT'S CLEAR THAT
"HEAL" IS GOING TO BE WELL
FUNDED IN THE YEARS AHEAD.
AND WE'RE ALREADY STARTING TO
THINK ABOUT WHAT BACPAC 2 WILL
LOOK LIKE.
WE WANT TO MAKE SURE WE'RE NOT
PREMATURE DEVELOPING PLANS.
WE WANT IT TO BE EVIDENCE-BASED
AND BUILD UPON NEW KNOWLEDGE
THAT COMES OUT OF BACPAC BUT
WE'RE EXCITED TO THINK ABOUT
WHAT'S NEXT.
WHAT CAN WE LEARN FROM THE
CURRENT PROGRAM?
AND WHAT WILL THAT SUGGEST WILL
THE BEST INVESTMENT ALSO MOVING
FORWARD?
CERTAINLY, YOU KNOW, THAT
CONCEPT OR REALLY CRIES OUT FOR
NCCIH INVOLVEMENT, SO LOOKING
FORWARD TO COLLABORATING WITH
ALL OF YOU IN A FUTURE VISION
FOR BACPAC.
>> GREAT.
>> I HAVE A QUESTION ABOUT THE
AMP PROGRAM.
SO EXCITING TO BE ABLE TO
UTILIZE I GUESS MOSTLY BIOPSIES,
I IMAGINE, FROM HUMAN TISSUE TO
START LOOKING AT CELLULAR
MECHANISMS, AND WONDERING, USING
AN APPROACH LIKE THIS, COULD WE
EXTEND IT TO OTHER CONDITIONS?
I SUPPOSE THE LIMITATIONS, YOU
HAVE TO GET THE TISSUES, BUT
THERE ARE MINIMALLY INVASIVE
TYPES OF, FOR EXAMPLE, NEEDLE
BIOPSIES, FOR EXAMPLE, THAT CAN
BE DONE, FOR EXAMPLE, MUSCLE.
DO YOU SEE THIS TYPE OF APPROACH
EXTENDING TO OTHER
MUSCULOSKELETAL CONDITIONS?
>> YEAH, YOU TOUCHED UPON A
REALLY CHALLENGING ASPECT OF THE
AMP PROGRAM WHICH WAS GETTING
ACCESS TO THE DISEASE TISSUES, A
CRITICAL GOAL.
I THINK AN ESSENTIAL FIRST STEP.
IT MADE THIS EFFORT CHALLENGING,
JUST DEVELOPING PROTOCOLS AND
REFINING THEM TO BE SUCCESSFUL,
NOT TO MENTION TRYING TO APPLY
CONSTANTLY EMERGING TECHNOLOGIES
TO STUDY THEM.
THERE'S SEVERAL WAYS LOOKING
FORWARD THIS COULD BE MORE
EASILY APPLIED ACROSS DISEASES
AND IN THE CLINIC EVEN.
SOME EFFORTS CURRENTLY IN MOVING
FORWARD WILL TRY TO LOOK AT THE
RELATIONSHIP BETWEEN FINDINGS IN
THE DISEASE TISSUE AND
PERIPHERAL BLOOD.
SO CAN WE IDENTIFY PERIPHERAL
BLOOD WHAT'S GOING ON IN THE
DISEASE TISSUE BASED ON WHAT
WE'RE LEARNING AS PART OF THE
AMP PROGRAM?
ANOTHER PIECE WE'RE STARTING TO
ADDRESS AS PART OF A BRAND-NEW
EFFORT THAT'S JUST GETTING UNDER
WAY NOW CALLED THE AMP SYSTEMS
OF BIOLOGY INFORMATION APPROACH
WILL TRY TO TAKE ADVANTAGE OF
DATASETS BEING DEVELOPED ACROSS
MULTIPLE DISEASE, IMMUNE,
INFLAMMATORY, METABOLIC, TO TRY
TO UNDERSTAND COMMON PATHWAYS
ACROSS VERY DIVERSE CONDITIONS.
SO, THAT WILL FACILITATE AND
ENABLE US TO GO FROM DISCOVERIES
IN ONE DISEASE AND UNDERSTAND
IMPLICATIONS AND RAMIFICATIONS
FOR OTHER CONDITIONS.
SO, THINK IT'S A REALLY TIMELY
AND CRITICALLY IMPORTANT THING
TO UNDERTAKE NOW SO WE'RE REALLY
THINKING HARD ABOUT THAT.
BUT ABSOLUTELY, ONE CAN ENVISION
A RANGE OF OTHER RHEUMATIC
DISEASES, OSTEOARTHRITIS, THAT
WOULD BE A GREAT DISEASE TO
STUDY WITH AN AMP SORT OF
APPROACH.
SO WE'RE TRYING TO NOT GET IN
OVER OUR HEAD AND TO REALLY
FOCUS INITIALLY ON A CORE SET TO
LEARN HOW TO DO THIS, TO LEARN,
YOU KNOW, WHAT IS DISTINCT,
WHAT'S COMMON ACROSS DIFFERENT
DISEASE GROUPINGS, AND THEN TO
TRY TO LEVERAGE OUR SUCCESSES TO
SECURE FUNDING AND COMMITMENT TO
EXPAND THE GROUP OF CONDITIONS.
BUT IT'S ALMOST LIMITLESS, THE
TIMES OF CONDITIONS THAT COULD
BE EXAMINED IN THIS SORT OF
APPROACH.
I DON'T KNOW HOW MANY ARE
FAMILIAR WITH THE AMP PROGRAM
BUT THERE'S IMPRESSIVE WORK IN
NEUROLOGIC DISEASE, ALZHEIMER'S,
PARKINSON'S DISEASE GETTING
ACCESSION TO CENTRAL NERVOUS
SYSTEM TISSUE, METABOLIC
CONDITIONS, NOW HEART DISEASE.
IT'S REALLY AN EXCITING PROGRAM
THAT WE CAN LEARN FROM ACROSS A
WIDE RANGE OF CONDITIONS MOVING
FORWARD.
>> IN SEEKING MYOFASCIAL PAIN,
WE STOPPED SHORT IN MYOFASCIAL,
YOU KNOW, RFA TO GOING AS FAR AS
BIOPSIES BUT THAT COULD BE
SOMETHING ELSE THAT COULD BE
LOOKED AT.
YOU KNOW, EVEN THOUGH -- IF
YOU'RE LOOKING FOR LONGITUDINAL
MEASUREMENTS, BIOPSIES ARE NOT
SO GREAT.
BUT IF YOU'RE LOOKING FOR
PHENOTYPING, YOU KNOW, IT MIGHT
BE THAT THAT COULD VERY WELL BE
USEFUL APPROACH.
IF DOING A SINGLE CELL RNAseq
ANALYSIS ON THE SAMPLE REVEALING
-- AND REALLY LOOKING AT ALL THE
DIFFERENT TYPES OF CELLS YOU CAN
FIND IN THE BIOPSY IS VERY, VERY
POWERFUL INDEED.
>> ONCE AGAIN, IF WE CAN
IDENTIFY PROXIES OR OTHER WAYS
TO, YOU KNOW, UNDERSTAND WHAT'S
GOING ON AT THE DISEASE TISSUE
LONGITUDINAL STUDIES BECOME MORE
FEASIBLE TOO.
>> RIGHT.
ANY OTHER QUESTIONS?
PERHAPS WHAT WE SHOULD DO, IF
THERE ARE NO OTHER QUESTIONS
RIGHT NOW, WHAT I COULD DO IS
RUN THROUGH MY SHORT SORT OF
FOLLOW-UP TO DR. CRISWELL'S TALK
WHICH IS ABOUT RESTORATION OF
JOINT HEALTH.
I THINK DR. CRISWELL IS GOING TO
BE ABLE TO STAY, IS THAT
CORRECT?
>> YES, I'M LOOKING FORWARD TO
HEARING YOUR THOUGHTS ABOUT
RE-JOIN AND WOULD BE HAPPY TO
STAY FOR THE DISCUSSION
FOLLOWING THAT AS WELL.
>> EXCELLENT.
I'M SURE -- YEAH, AND THEN WE
CAN GET BACK INTO QUESTIONS AND
INCORPORATE THEMES BECAUSE I
THINK WE'RE GOING TO FIND SOME
GOOD AREAS TO TALK ABOUT.
LET ME SHARE MY SCREEN.
THERE WE GO.
OKAY.
CAN YOU ALL SEE THIS?
>> YES.
>> OKAY.
SO, THIS IS KIND OF A
PHILOSOPHICAL SORT OF DISCUSSION
ON WHAT I'M CALLING HERE WHOLE
JOINT HEALTH, RESTORING WHOLE
JOINT HEALTH, REALLY KIND OF A
FOLLOW-UP TO THE DISCUSSION THAT
WE'RE HAVING A LOT AT NCCIH, IN
TERMS OF WHOLE PERSON HEALTH.
ALL OF YOU HERE AT COUNCIL ARE
FAMILIAR OBVIOUSLY THAT WHOLE
PERSON HEALTH HAS BEEN EMERGING
THEME OUT OF OUR NEW STRATEGIC
PLAN.
REALLY DEFINING THIS, WHOLE
PERSON HEALTH, IS HELPING
INDIVIDUALS RESTORE THEIR HEALTH
IN MULTIPLE INTERCONNECTED
DOMAINS, BEHAVIORAL, BIOLOGICAL,
SOCIAL, ENVIRONMENTAL.
WE HAVE DISCUSSION INCLUDING
HERE AT COUNCIL ABOUT WHY IS THE
WORD "PERSON" -- THERE'S A
CONCEPT OF WHOLE HEALTH, REALLY
TAKEN HOLD IN THE COMMUNITY THAT
REALLY ENCOMPASSES THIS.
YOU COULD DESCRIBE THIS, WHAT I
JUST TALKED ABOUT, IN TERMS OF
CALLING IT WHOLE HEALTH.
BUT THERE'S A REASON WHY WE
WANTED WORD "PERSON" IN HERE.
HERE IS WHY.
BECAUSE WHEN YOU'RE TALKING
ABOUT WHOLE PERSON HEALTH,
WITHIN THE BIOLOGICAL REALM, WE
HAVE MANY DIFFERENT SYSTEMS IN
THE BODY THAT TEND TO BE
STUDIED, NOT ALWAYS, BUT A LOT
OF TIMES KIND OF SEPARATE FROM
EACH OTHER.
CARDIOVASCULAR, METABOLIC, ET
CETERA.
AND MUSCULOSKELETAL.
AND THAT WE WANTED TO MAKE AN
EFFORT IN THIS WHOLE PERSON
HEALTH KIND OF THEME TO
INTEGRATE ACROSS VARIOUS
SYSTEMS.
FURTHERMORE WE WANT TO MAKE SURE
THIS INTEGRATION OCCURRED AT ALL
THE VARIOUS LEVELS I MENTIONED
BEFORE.
BIOLOGIC, BEHAVIORAL, SOCIAL,
ENVIRONMENTAL.
SO THAT THE HEALTH OF YOUR
LUNGS, FOR EXAMPLE, WOULD BE OF
COURSE AT THE TISSUE LEVEL,
HEALTHY LUNG TISSUE, ALSO AT THE
BEHAVIORAL LEVEL, FOR EXAMPLE,
YOU KNOW, BREATHING, FOR
EXAMPLE, INCORPORATED INTO AN
EXERCISE ROUTINE FOR EXAMPLE
YOGA.
SOCIAL AND ENVIRONMENTAL, ARE
YOU ABLE TO BREATHE CLEAN AIR?
WHAT ARE FACTORS THAT IMPACT
SOMEBODY'S RESPIRATORY HEALTH?
AS FAR AS MUSCULOSKELETAL
SYSTEM, SAME WOULD APPLY.
BIOLOGIC, STATUS OF JOINTS,
BONES, MUSCLE.
BEHAVIORAL, WHAT PHYSICAL
ACTIVITY DO YOU DO?
WHAT ARE SOCIAL AND
ENVIRONMENTAL FACTORS WHETHER OR
NOT YOU CAN EXERCISE OUTSIDE OR
SAFELY IN A GYM?
AND WHAT ARE FACTORS THAT IMPAIR
AND DON'T PROMOTE IT?
WE WANTED TO THINK ABOUT THE
IDEA THE WHOLE PERSON HEALTH
WITH WHAT WE CALL VERTICAL
INTEGRATION, INTEGRATING BODY
PARTS, AND THEN HORIZONTAL
INTEGRATION, WHICH IS THAT ALL
OF THIS, ALL OF THESE VARIOUS
FACTORS, ARE ON A CONTINUUM
BETWEEN HEALTH AND DISEASE, NOT
JUST SORT OF INEXORABLE
PROGRESSION TOWARDS DISEASE THAT
YOU CAN UNDERSTAND CERTAIN
CIRCUMSTANCES AND ESPECIALLY IF
SEEN AND TREATED EARLY, YOU CAN
RETURN, AT LEAST STOP THE
DISEASE PROGRESSION IF YOU'RE,
YOU KNOW, BUT ALSO PERHAPS
RESTORE FUNCTION, RESTORE
HEALTH.
SO WE WERE THINKING THAT THE
SAME MODEL COULD BE APPLIED TO
SOMETHING LIKE A JOINT, AND HOW
WOULD THAT WORK?
WELL, IF YOU THINK ABOUT THIS,
SIMILAR TO WHOLE BODY CONCEPT,
WHOLE PERSON HEALTH CONCEPT, THE
JOINT, AS DR. CRISWELL
MENTIONED, HAS MANY COMPONENTS,
RIGHT?
WE THINK ABOUT THE JOINT AS
BEING THIS KIND OF INNER PART OF
THE JOINT, CARTILAGE AND
ARTICULAR SURFACES BUT THERE'S
ALSO CAPSULE, SYNOVIUM,
LIGAMENTS AND MUSCLES.
THE CONTINUUM, IF YOU THINK
ABOUT WHOLE JOINT HEALTH, WHAT
ARE FACTORS THAT COULD INFLUENCE
WHETHER OF WHETHER A PARTICULAR
JOINT MIGHT BE GETTING HEALTHIER
OR LESS HEALTHY.
AND PUTTING THIS IN CONTEXT OF
VARIOUS DOMAINS, INFLUENCED BY
OTHER TYPES OF FACTORS.
WE STARTED THIS CONVERSATION
ABOUT THE JOINT INITIATIVE BY
STARTING TO THINK ABOUT WHAT ARE
VARIOUS COMPONENTS AND IS IT
POSSIBLE TO IDENTIFY COMPONENTS
THAT ARE ESSENTIALLY COMMON TO
ALL THE JOINTS.
THEY MIGHT NOT LOOK EXACTLY THE
SAME FROM ONE JOINT TO ANOTHER,
FOR EXAMPLE A TEMPOROMANDIBULAR
OR HIP JOINT OR KNEE JOINT.
THEY DON'T LOOK THE SAME, BUT
ALL OF THEM HAVE CERTAIN VARIOUS
COMPONENTS.
CARTILAGE, SYNOVIUM, JOINT
CAPSULES, LIGAMENTS, MUSCLES.
TO STUDY IN A WAY TRANSLATED
ACROSS JOINTS MIGHT BE USEFUL.
THIS LOOKS DIFFERENT, THE
TEMPOROMANDIBULAR, BUT YOU SEE
ALL THE COMPONENTS ARE THERE
WITH ONE ADDITIONAL, THE
INTRAARTICULAR DISK, FIBRO
CARTILAGE COMPONENT IN THE
MIDDLE.
IF THIS WERE A KNEE YOU WOULD
HAVE A MENISCUS.
BUT THE OTHER COMPONENTS WOULD
BE THERE.
AND SO THAT'S THE FIRST SORT OF
THOUGHT ABOUT TRYING TO CREATE A
STRUCTURE TO THINK ABOUT JOINTS
IN A WAY THAT WOULD BE A LITTLE
BIT MORE UNIVERSAL OR GENERIC.
HOW COULD YOU THINK ABOUT A
JOINT UNIT?
THE SAME WAY WE STARTED TALKING
ABOUT MYOFASCIAL PAIN, TALKING
ABOUT THE MYOFASCIAL UNIT,
MEANING MUSCLES AND ASSOCIATED
CONNECTIVE TISSUE, PLUS LET'S
APPLY LYMPHATICS AND
INNERVATION.
SAME THING.
GENERIC JOINT UNIT WOULD INCLUDE
ARTICULAR AND PERIARTICULAR
COMPONENTS, PLUS ASSOCIATED
INNERVATION AND VASCULAR AND
LYMPHATIC SUPPLY.
THE JOINT INITIATIVE THAT DR.
CRISWELL MENTIONED KIND OF WENT
AND STARTED WITH THESE BASIC
IDEAS, TO MAP THE DIFFERENT
TYPES AND WE DECIDED TO FOCUS ON
SENSORY NEURONS, RIGHT?
THIS WAS KIND OF, YOU KNOW,
INNERVATING ARTICULAR AND
PERIARTICULAR TISSUES, AUTONOMIC
SYMPATHETIC NERVE, SENSORY
NEURONS ARE IMPORTANT WHEN YOU
TALK ABOUT PAIN.
DOES THIS INNERVATION CHANGE
WITH AGE, PHYSICAL ACTIVITY,
WITH JOINT DEGENERATION,
ARTHRITIS?
HOW IS THIS INNERVATION
AFFECTED?
AND THIS WOULD UTILIZE ANIMAL
MODELS, HUMAN TISSUE OR BOTH.
AND HAVE A CONSORTIUM THAT WOULD
INTEGRATE DATA ACROSS VARIOUS
TYPES OF JOINTS.
WHAT WE WERE THINKING ABOUT,
THIS RE-JOIN, CURRENT RE-JOIN
HEAL RFA FOR 2022 WOULD BE THE
IDEAL STARTING POINT FOR A
LONGER INITIATIVE ABOUT
RESTORING JOINT HEALTH AND HOW
WOULD THAT WORK?
WELL, THINK ABOUT STARTING WITH
JOINT PAIN, LOOKING AT ARTICULAR
TISSUES THEMSELVES, RIGHT?
CARTILAGE, RIGHT?
ASSOCIATED BONY TISSUES.
AND ALSO SYNOVIUM.
WHAT WE KNOW RIGHT NOW IN
LITERATURE, THERE'S ESTABLISHED
GOOD DATA SUGGESTING THAT IN THE
PRESENCE OF SPECIALLY
DEGENERATIVE JOINT DISEASES WE
HAVE CHANGES IN THESE TISSUES
WITH RESPECT TO INNERVATION AND
VASCULAR SUPPLY.
WE GET INGROWTH OF NERVES.
NORMALLY CARTILAGE DOES NOT HAVE
NOCICEPTORS AND IS AVASCULAR
BLOOD CAPPERS CAPILLARIES.
YOU CAN GET INGROWTH OF
NOCICEPTORS AND SYMPATHETIC
NERVES INTO THE CARTILAGE AND
SUBCONDRIA BONE.
SAME WITH SYNOVIUM, NOCICEPTOR
SENSITIZATION, MECHANISMS THAT
ARE KNOWN, THAT ARE ESTABLISHED.
WHAT WE WOULD LIKE TO DO HERE IS
EXPAND OUR VIEW OF JOINT PAIN
AND START TO THINK ABOUT WHAT
OTHER TYPES OF MECHANISMS IN
PERIARTICULAR TISSUES MAY ALSO
PERHAPS CONTRIBUTE TO JOINT
PAIN.
IF YOUR KNEE HURTS, FOR EXAMPLE,
WELL WE DON'T REALLY KNOW IF THE
PAIN IS ACTUALLY COMING FROM THE
ARTICULAR TISSUES THEMSELVES,
I.E. CARTILAGE AND SYNOVIUM OR
COMING FROM TISSUES AROUND THE
JOINT?
A PERSON WOULD NOT KNOW THIS,
RIGHT?
MY KNEE HURTS WAY ONE OR
ANOTHER, BUT IT'S POSSIBLE YOU
COULD HAVE NOCICEPTOR
SENSITIZATION FOR EXAMPLAR IN
THE JOINT CAPSULES OR LIGAMENTS
THAT WOULD FEEL LIKE JOINT PAIN.
WE DON'T HAVE KNOWLEDGE BECAUSE
WE HAVEN'T STUDIED THIS AS MUCH.
WE HAVEN'T STUDY MYOFASCIAL PAIN
AND PRESENCE OF MYOFASCIAL
TRIGGER POINTS, POSSIBLY NEAR
THE INSERTION OF THE MUSCLES
INTO THE JOINTS, INTO THE
CAPSULES AND LIGAMENTS BECAUSE
THESE CONNECTIVE TISSUES, THEY
ARE DRAWN HERE IN SEPARATE
COLORS BUT ONE IMPOSE INTO THE
OTHER.
THERE'S NOT A LINE THAT SAYS,
OKAY, HERE IS WHERE THE FASCIA
STARTS, STOPS, WHERE THE
LIGAMENT STARTS.
IT ALL RUNS INTO ITSELF.
SO, WE HAVE A SEPARATE
INITIATIVE LOOKING AT DEVELOPING
MARKERS FOR MYOFASCIAL PAIN, AND
WE THINK THIS WOULD BE HELP
UNDERSTAND NOT ONLY MYOFASCIAL
TISSUES BUT ALSO JOINTS.
SO, THE IDEA THAT IF WE COULD
UNDERSTAND BETTER HOW TO
DIAGNOSE AND TREAT MYOFASCIAL
TRIGGER POINTS IT MY VERY WELL
BE HELPFUL IN THE MANAGEMENT OF
JOINT PAIN.
OKAY.
SO, NOW HERE WE'VE LOOKED AT --
THERE MAY BE ANOTHER REASON WHY
WE WANT TO LOOK AT THIS.
THE REASON IS THAT THERE MAY BE
A RELATIONSHIP, TEMPORALLY,
BETWEEN SUPPORTING STRUCTURES
AND ARTICULAR SURFACES.
IMAGINE THAT YOU HAVE A JOINT
OVER HERE ON THE LEFT WHERE
SOMEBODY HAS AN IMBALANCE IN THE
MUSCLE ACTIVITY, ON ONE SIDE
MUSCLES ARE CONTRACTED, PERHAPS
UNDERUSED, PERHAPS A PERSON IS
FAVORING ONE SIDE AND THE JOINT
IS GOING OUT OF ALIGNMENT
BECAUSE FUNCTION OF THE MUSCLES
HAS BECOME UNBALANCED.
SIMILARLY CONNECTIVE TISSUES ON
ONE SIDE HAVE OF MAY HAVE GOTTEN
THICKER AND STUFF SO THERE'S NOT
AN OPTIMUM MOBILITY OF THESE
TISSUES WHICH FURTHER IMBALANCES
JOINT MECHANICS.
SO IF YOU HAVE A COMBINATION OF
WEAK MUSCLES, STIFF CONNECTIVE
TISSUES AND MISALIGNED JOINT,
THIS MALFUNCTION IN DEGENERATION
OF SUPPORTED STRUCTURES COULD
PREDISPOSE AND LEAD TO DAMAGE TO
THE ARTICULAR SURFACES.
THIS JUST MAKES COMMON SENSE,
RIGHT?
IF YOU HAVE A JOINT THAT IS NO
LONGER WELL ALIGNED YOU MAY HAVE
INCREASED WEAR ON ONE SIDE OF
THE ARTICULAR SURFACE, THE
CARTILAGE, AND INCREASED
(INDISCERNIBLE).
IT COULD BE PERSON UNDERSTANDING
WHY THE JOINT BECOMES
DEGENERATED BUT MOST IMPORTANTLY
ALSO COULD BE PREVENTED, IF IT
WAS ADDRESSED.
SO, THE IDEA HERE WOULD BE THAT
THESE -- IF YOU COULD DEVELOP A
WHOLE PERSON JO OF -- VIEW OF
JOINT PAIN IT COULD INCLUDE
OTHER FACTORS THAT I MENTIONED
EARLIER, ENVIRONMENTAL,
PSYCHOLOGICAL FACTORS, OBESITY,
POSTURE HABITS, MOVEMENT
PATTERNS, STRESS, MUSCLE
TENSION, ALL THESE THINGS MAY
HAVE EFFECT ON THE FUNCTIONING
OF THE WHOLE JOINT UNIT.
AND SO THE IDEA WE HAVE KIND OF
A VICIOUS CIRCLE SETUP WHERE THE
MORE PAIN YOU HAVE, THE MORE
DIFFICULT TO EXERCISE, POSTURE
MAY FURTHER DETERIORATE, MORE
TIME SETTING, WEIGHT GOES UP, WE
KNOW A LOT OF THESE SITUATIONS,
CONDITIONS, ARE CO-OCCURRING.
PATIENTS WHO HAVE PROBLEMS, POOR
DIET, SEDENTARY LIFESTYLE, OFTEN
HAVE SOMETIMES DEPRESSION, A LOT
HAVE CHRONIC PAIN, A LOT OF
CHRONIC PAIN IS CHRONIC JOINT
PAIN. SO THINKING ABOUT THE
CONTINUUM BETWEEN HEALTH AND
DISEASE WHERE YOU MIGHT BE ABLE
TO INTERVENE AND PERHAPS
PREVENT OR RETAIN BY LOSING UP
TISSUES AND ADHESIONS, MAYBE
LOOSENING THOSE UP,
STRENGTHENING MUSCLES THAT HAVE
BECOME WEAK AND ENGAGING,
CORRECTING THE POSTURE, ALL OF
THESE THINGS MAY HAVE AN EFFECT
ON THE DEVELOPMENT AND PERHAPS
REVERSAL OF THE JOINT PATHOLOGY.
SO, OPPORTUNITIES, RIGHT, FOR
PREVENTION AND RESTORATION,
INCLUDING NUTRITIONAL,
PSYCHOLOGICAL, PHYSICAL, BY
IMPROVING ALL OF THESE VICIOUS
CIRCLES, START GOING BACK IN THE
OTHER DIRECTION, IMPROVING SORT
OF, FOR EXAMPLE, LOCAL MANUAL
THERAPIES, FOR EXAMPLE, APPLIED
TO CONNECTIVE TISSUE TO LOOSEN
THEM, MOVEMENT THERAPIES,
PHYSICAL THERAPY TO STRENGTHEN
MUSCLES WHERE THEY NEED TO BE,
AND THEN OF COURSE IMPROVING,
FOR EXAMPLE, ACCESS TO ALL OF
THESE TYPES OF THERAPIES AND,
FOR EXAMPLE, EXERCISE, AND
IMPROVING THAT FROM THE SOCIAL
STANDPOINT.
SO YOU CAN SEE ADDRESSING THESE
VARIOUS DIFFERENT COMPONENTS OF
JOINT PAIN FROM THE FULL PERSON
DOWN TO THE CARTILAGE CAN HELP
US TO UNDERSTAND BETTER HOW WE
CAN PREVENT PROBLEMS AND
EVENTUALLY GOING BACK TO THE
ORIGINAL AIM OF RE-JOIN, WHICH
IS TO MAP SENSORY INNERVATION
AND OF COURSE ALSO SYMPATHETIC
IS VERY IMPORTANT I THINK AS
WELL, TO PERHAPS UNDERSTAND
WHETHER SOME OF THIS,
NEOVASCULARIZATION AND INGROWTH
IN CARTILAGE MIGHT BE
REVERSIBLE.
AND SO I THINK THAT THE
IMPORTANT THING WILL BE TO
FOLLOW UP ON THIS INITIAL
RE-JOIN PROGRAM, WITH
INTERVENTIONS THAT MAY BE
APPLIED TO THIS, AT VARIOUS
STAGES OF PROGRESSION ALONG THIS
CONTINUUM, TO SEE WHETHER IT'S
POSSIBLE TO REALLY RESTORE THE
HEALTH OF THE JOINT.
SO, I HOPE I HAVE CONVINCED YOU
THIS IS AN AREA WHERE THE
CONCEPT OF WHOLE PERSONAL HEALTH
CAN BE PRETTY MUCH COPIED AND
PASTED, RIGHT?
ONTO THE CONCEPT OF WHOLE JOINT
HEALTH.
YOU HAVE THE WHOLE INTEGRATION
OF ALL OF VARIOUS PIECES AND YOU
HAVE THE SORT OF TIME COMPONENT,
HEALTH TO DISEASE, THE BACK AND
FORTH CONTINUUM.
IF THIS CAN BE DONE FOR JOINTS
IT CAN BE DONE FOR OTHER THINGS.
I LOVE THE IDEA OF WHOLE
DIGESTIVE HEALTH.
THE DIGESTIVE SYSTEM IS NOT
ISOLATED IN THE BODY.
IT'S NOT JUST A TUBE.
IT'S SURROUNDED BY ORGANS BY
MUSCLES, THE DIAPHRAGM, LUNGS
THAT BREATHE.
YOU KNOW, THERE'S ALL KINDS OF
ACTIVITY GOING ON THAT COULD
INFLUENCE DIGESTION, PLUS DIET,
MICROBIOME, OUTSIDE WORLD, THE
EXERCISE WE DO.
THE IDEA THIS CONCEPT OF WHOLE
PERSON HEALTH CAN REALLY BE
APPLIED AT A SYSTEMS LEVEL AND I
THINK THAT JUST SORT OF THINKING
ABOUT IT, AT ALL THE DIFFERENT
COMPONENTS IN TERMS OF WHAT PUTS
THE WHOLE PERSON TOGETHER AND
HOW DOES IT INTERACT WITH THE
OUTSIDE WORLD AND MOVE BACK AND
FORTH IN HEALTHY DISEASE IS AN
AREA WE CAN -- IT'S LIKE A
BLUEPRINT TO LOOK AT A VARIETY
OF DIFFERENT SITUATIONS.
SO I'LL STOP HERE.
I LOOK FORWARD TO HEARING WHAT
PEOPLE THINK.
>> QUESTIONS, COMMENTS FROM
COUNCIL?
>> IF I CAN JUST SAY THANK YOU
SO MUCH.
IT STRUCK ME SO MUCH WITH YOUR
PRESENTATION, THINKING ABOUT
THIS EFFORT, IT REALLY NICELY
ILLUSTRATES THE TREMENDOUS
OPPORTUNITY AT THE NIH WITH THE
DIFFERENT INSTITUTES AND AREAS
OF EXPERTISE.
THIS RE-JOIN CONCEPT AND THE
EXTENDED PROPOSAL, YOU KNOW,
OBVIOUSLY VERY IMPORTANTLY
REFLECTS PERSPECTIVE THAT NCCIH
BRINGS TO THIS AND THE KIND OF
NEUROLOGIC ASPECT REFLECTS
EXPERTISE, AND NIAMS
INVESTIGATORS CONTRIBUTED TO
THINKING ABOUT THIS, A GREAT
COLLABORATION ACROSS I.C.s TO
CREATE SOMETHING THAT WOULDN'T
HAVE HAPPENED IN ANY OF THE
I.C.s ON THEIR OWN.
>> I SAID IT PERFECTLY, LINDSEY.
I HAVE TO SAY IT IS YOU,
LINDSEY, WHO INITIATED THIS,
WORKING TOGETHER TO LOOK AT
JOINTS.
AND THEN WE STARTED TALKING
ABOUT JOINT HEALTH.
THEN WE STARTED TALKING ABOUT
SENSORY NERVES.
AND THEN ALL OF A SUDDEN THERE
WAS THIS CONCEPT THAT SORT OF
CAME TOGETHER.
SO I THINK THIS IS REALLY
SPEAKING VOLUMES HOW TO ALL THE
DIFFERENT INSTITUTES CAN COME
TOGETHER AND DO SOMETHING WE
HAVEN'T DONE BEFORE.
>> DR. EVANS AND DR. SHERMAN.
>> THANK YOU FOR THE WONDERFUL
TALK.
I LOVE IT.
AT FIRST WHEN YOU WERE STARTING
OUT, IT WAS JUST FOCUSED ON
INDIVIDUAL ELEMENTS OF THE
JOINT, I WAS ON BOARD WITH
COMMONALITY OF LOOKING AT JOINTS
BUT THEN WHEN YOU PUT IN THE
REST OF THIS, PSYCHOSOCIAL I
GOT EXCITED.
THIS IS SOMETHING, THE
WHOLE-PERSON, WHOLE-SYSTEMS
APPROACH IS SOMETHING THAT'S
IMPORTANT FOR ALL CHRONIC HEALTH
CONDITIONS.
VERY EXCITING.
FOR THOSE OF US FAMILIAR WITH
NCCIH'S PORTFOLIO, IT'S ALSO
VERY CONGRUENT WITH A LOT OF THE
WHOLE SYSTEMS APPROACHES AND
COMPLEMENTARY AND INTEGRATIVE
HEALTH.
WE MIGHT CALL THESE DIFFERENT
THINGS, IT'S THAT FOR A LONG
TIME THE WHOLE SYSTEMS
APPROACHES HAVE BEEN LOOKING AT
THINGS THIS WAY.
SO THIS LOOKS WONDERFUL.
>> GREAT.
THANK YOU.
DR. SHERMAN?
>> I SUSPECT THAT RONI STOLE A
LITTLE BIT OF MY THUNDER.
I'LL RECONCEPTUALIZE A LITTLE
BIT AND DO SOME SPECULATION
FURTHER OUT.
MAYBE BECAUSE TOWARD THE END OF
MY CAREER, I FEEL LIKE I CAN SEE
SOME WAYS THINGS CAN GO INTO THE
FUTURE.
FOR ONE THING, I LOVE THE IDEA.
I THINK IT PROVIDES A FRAMEWORK
FOR THE DEVELOPMENT OF THE BEST
SETS OF THERAPIES AND POSSIBLY
BY UNDERSTANDING THE BIOLOGY
SOME KIND OF IDEA WHAT YOU HAVE
TO DO FIRST.
DO YOU HAVE TO STRETCH THE
TISSUE, SAY, IN A MORE PHYSICAL
INTERVENTION FOR OPTIMAL RESULTS
BEFORE YOU UNDERTAKE, YOU KNOW,
YOGA STRETCHING OR TAI CHI,
THINGS THAT WILL BE INTERESTING
AND THEN CAN BE CUSTOMIZED BY
PHYSICAL THERAPISTS AND OTHERS
AS WE BETTER UNDERSTAND HOW IT
PROVIDES AND PROVIDES, TO MY
WAY, A WAY OF UNDERSTANDING
THERAPIES LIKE YOGA AND TAI CHI
THAT HAVE DIFFERENT COMPONENTS
BUT HOW DO YOU PUT THEM
TOGETHER?
YOU MIGHT DO SOMETHING DIFFERENT
FOR A FOCUS ON THE JOINT THAN
FOR CARDIOVASCULAR OR OTHER
THINGS LIKE THAT.
THOSE COULD BE OPTIMIZED FOR
THOSE THAT PREFER SOMETHING
WITHOUT SCIENTIFIC NAMES, THAT
COULD STILL WORK REALLY WELL.
I LOVE THE IDEA OF EXTENDING
THIS TO OTHER SYSTEMS, USING THE
SAME FRAMEWORK.
I SUSPECT WE'LL FIND INTERESTING
DIFFERENCES AND FASCINATING
COMMONALITIES.
AFTER WE'VE DONE THIS FOR, I
DON'T KNOW, FIVE OR SYSTEMS
MAYBE THE 100th MONKEY WILL BE
THE FRAMEWORK FOR GENERAL
PREVENTION, TEACHING CHILDREN AT
2 YEARS OLD, 5 YEARS OLD, 10
YEARS OLD, FUN BY THE TIME THEY
ARE TEENAGERS TO REBEL AGAINST
THEIR PARENTS BY BEING REALLY
HEALTHY OR WHATEVER.
MOVE THAT OUT.
BUT THOSE ARE SOME OF THE THINGS
THAT POPPED INTO MY MIND.
YOU HAVE ON THE FORM THAT TURNS
OUT TO BE TRUE, I THINK IT'S A
VERY USEFUL HUERISTIC, SO THANK
YOU SO MUCH.
>> THANK YOU.
>> ANY OTHER COMMENTS?
>> I'M WONDERING IF I CAN SEE
MORE DISCUSSION.
WE HAVE A GREAT COLLECTION OF
ACADEMICS HERE ON COUNCIL FROM
THEIR OWN INSTITUTIONS, ALL OF
WHOM -- MANY OF WHOM HAVE BEEN
INVOLVED IN THIS.
I'M THINKING JUST BECAUSE TONY
HAPPENS TO BE ON MY HOLLYWOOD
SQUARES HERE HOW WOULD THIS BE
TAUGHT, AS WELL AS RESEARCHED,
IN YOUR RESPECTIVE INSTITUTIONS.
BOTH DR. CRISWELL AND DR.
LANGEVIN PROPOSED SOMETHING
FAIRLY BOLD IN LOOKING AT BOTH
OF RE-JOIN INITIATIVE AND THE
WHOLE JOINT HEALTH, HOW DO YOU
THINK ABOUT THIS IN YOUR OWN
INSTITUTIONS, ACADEMIC SILOS
THAT ANY INSTITUTION HAS.
>> IF YOU PICKED ON ME FIRST,
WHAT WE TEACH FOLLOWS THE
EVIDENCE, WE NEED TO EXPLORE THE
EVIDENCE.
THE THING THAT INTRIGUES ME, NOT
JUST THE SCIENTIFIC PROCESS AND
ELIMINATING CAUSE OF CHRONIC
CONDITIONS THAT NEEDS TO EXPAND
OF WHOLE BODY, TO DEVELOP WHOLE
BODY ENTIRE VENGES AND --
INTERVENTION AND COMPARE THEM.
MUSCULOSKELETAL, WE'RE SPENDING
ENORMOUS ENORMOUS AMOUNT OF
MONEY ON LOW VALUE CARE, LOOKING
FOR THE STRAW DOG TO COMPARE
THAT BUT IMAGINE THE COMPARATOR,
SOMETHING THAT HAS A BASIS AND
CAN BE EFFECTIVE, THAT COULD
REALLY TURN THE TIDE ON SOME OF
THE LOW VALUE CARE THAT'S GOING
ON OUT THERE.
IT WOULD BE HARD, IT'S ONE THING
TO SAY, GEE, THIS INTERVENTION
WAS EQUAL TO SURGERY FOR LUMBAR
SPINAL STENOSIS, ANOTHER THING
TO SAY THIS INTERVENTION IS
BETTER FOR THE PERSON AND
OUTCOME IS WAY BETTER THAN
SURGERY, THAT WOULD BE A GAME
CHANGER FOR THE HEALTH SYSTEMS
OUT THERE.
>> THANK YOU.
LORI?
>> I WANT TO APPLAUD THIS
EFFORT.
BEING A PAIN CLINICIAN FOR THE
FIRST 20 YEARS OF MY CAREER THIS
IS MUSIC TO MY CAREERS.
I WANT TO LINK THIS TO THE
CLINICAL ENVIRONMENT AND
VALUE-BASED PAYMENT.
THE TIMING COULDN'T BE MORE
RIGHT.
AS WE'RE LOOKING AT NOT ONE
INTERVENTION IN FREE FOR
S ERVICE -- FEE FOR SERVICE BUT
THE WHOLE PERSON OVER THE
LIFETIME, THIS IS AN IMPERATIVE
TO THAT.
I'M NEW TO THE COUNCIL, MY FIRST
DAY, ALREADY SO INSPIRED.
>> OTHER COMMENTS OR QUESTIONS
BY COUNCIL MEMBERS?
>> I WAS GOING TO ASK A
QUESTION.
I WANTED TO DEFER TO THOSE ON
COUNCIL FIRST.
>> DR. SONNENBERG?
>> THIS WAS A REALLY BEAUTIFUL
PICTURE THAT YOU BOTH SKETCHED.
I THINK WHAT MAY BE EVEN MORE
EXCITING IS THE POSSIBILITY OF
USING THIS AS TEMPLATE.
ANALOGY TO DIGESTIVE SYSTEM AT
THE END WAS POTENTIALLY EXAMPLE
OF THAT BUT I'M CURIOUS IF THERE
ARE OTHER AREAS THAT ARE AT THE
KIND OF FRONT OF YOUR MIND WHERE
THIS COULD BE OVERLAID AND
EXPANDED BECAUSE I THINK, YOU
KNOW, INTEGRATIVE VIEW OF
SYSTEMS IS WHAT'S ON THE HORIZON
HERE, AND SO I THINK THAT, YEAH,
I'D BE CURIOUS TO HEAR YOUR
THOUGHTS WHERE THIS COULD
EXPAND.
>> WELL, WE'VE BEEN SPENDING
TIME THINKING ABOUT THAT.
WE HAD A WORKSHOP ON WHOLE
PERSON RESEARCH, RIGHT?
AND PART OF THAT, THE FIRST
SESSION OF THAT WAS ABOUT
INTERCONNECTED SYSTEMS, SOME OF
THE PRESENTATIONS AT THAT
WORKSHOP WERE UNBELIEVABLE.
AND I THINK THE PLACE WHERE WE
NEED TO INTEGRATE, THERE ARE
SOME SYSTEMS, FOR EXAMPLE,
IMMUNE OR ENDOCRINE SYSTEM, SORT
OF INTEGRATED ALREADY.
THEY INTERACT WITH THE WHOLE
BODY.
BUT EVEN LIKE THE ENDOCRINE
SYSTEM, WHERE DOES IT INTERFACE
WITH OTHER SYSTEMS, FOR EXAMPLE,
THE MUSCULOSKELETAL SYSTEM OR
IMMUNE SYSTEM, THAT'S THE KIND
OF INTERFACE WHERE WE CAN REALLY
START MAKING SOME PROGRESS.
SO IMAGINE THINKING REPRODUCTIVE
HEALTH.
IT'S OB/GYN, RIGHT?
IT'S A LOT MORE BECAUSE YOU HAVE
ALL THESE PELVIC ORGANS SITTING
THERE, WELL, THERE'S STUFF
AROUND THEM.
AND THEY ARE SITTING RIGHT NEXT
TO, GUESS WHAT, THE BLADDER.
THEY ARE SITTING NEXT TO THE
COLON.
THEY ARE SITTING RIGHT NEXT TO
THE LUMBAR SPINE AND SACRUM.
THERE'S A LOT OF THINGS THERE.
WE DON'T THINK ANATOMICALLY.
WE THINK ONE SYSTEM AT A TIME.
OF COURSE THE ENDOCRINE SYSTEM
IS BATHING ALL OF THIS, I COULD
KEEP GOING.
YOU SEE WHAT I MEAN?
THERE'S DIFFERENT INTEGRATION.
THERE'S ACROSS SYSTEM AND THE
MOST INTERESTING IN MY OPINION
IS ACROSS ANATOMY BECAUSE THAT
TENDS TO GET FOSSILIZED, JUST
LIKE WHEN WE TALKED ABOUT
DIFFERENT PARTS OF THE JOINT.
THE MYOFASCIAL TISSUES HAVE BEEN
LEFT OUT OF ANATOMY FOR
CENTURIES.
THEY ARE NOT EVEN THERE.
THEY ARE NOT EVEN PART OF HOW WE
THINK OF ANATOMY.
THERE'S A LOT OF POTENTIAL OUT
THERE.
>> DR. LOREETSKI AND DR. HENSON?
>> I'M RESPONDING ABOUT HOW TO
TEACH THIS INTEGRATION OR WHOLE
PERSON APPROACH.
POST-COVID, PUT IS IN THE
SESSION WHEN IT'S NECESSARY TO
DO SO.
I RUN A POST-COVID CLINIC IN
INDUSTRY BUT I INTERACT WITH
OTHER SUBSPECIALITIES THAT ARE
TAKING CARE OF PATIENTS, AND
SUCH APPROACH IS NECESSARY, LIKE
RECONSTRUCTING OUR HEALTH CARE
SYSTEM AND RESEARCH THAT'S
COLLABORATIVE IN NATURE.
POST-COVID CARE PRESENTED THIS
OPPORTUNITY TO RETHINK HOW WE
APPROACH PROBLEMS.
>> THANK YOU.
DR. HENSEL?
>> I WAS REALLY GLAD TO HEAR
WHAT YOU WERE JUST TALKING
ABOUT, AND WHAT YOU JUST SAID
COULD HAVE REALLY BEEN A WELCOME
TO OSTEOPATHIC MEDICAL SCHOOL
PRESENTATION.
BECAUSE THAT'S EXACTLY HOW WE
TEACH.
WHEN WE'RE TEACHING ON OUR
APPROACH TO THE MUSCULOSKELETAL
SYSTEM WE ACTUALLY BREAK IT DOWN
BY SYSTEMS.
WE TEACH INTERACTING WITH THE
RESPIRATORY SYSTEM AND
TECHNIQUES THAT APPROACH THAT OR
INTERACTING WITH THE G.I. SYSTEM
OR REPRODUCTIVE SYSTEM.
ENDOCRINE IS A LOT MORE
THEORETICAL.
AS YOU CAN PROBABLY IMAGINE, WE
DO HAVE SOME ANATOMICAL -- A LOT
OF OUR CRANIAL TECHNIQUES MANY
BODY WORKERS ALSO DO, THEORIZED
TO HAVE SOME EFFECT ON THE
ENDOCRINE SYSTEM.
WE DON'T HAVE A LOT OF DATA ON
IT.
BUT IT'S SOMETHING THAT WE'VE
TAUGHT FOR 140 YEARS THAT THE
INTERACTION BETWEEN THE BODY
SYSTEMS, THAT THE SILOS WHERE
IT'S TAUGHT SOMETIMES, WHERE
IT'S RESEARCHED OR TREATED
SOMETIMES, IS A FALSE
DELINEATION.
REALLY THAT YOU CAN'T SEPARATE
RESPIRATORY FROM G.I., WHEN YOU
START TALKING ABOUT THE MOTION
OF THE DIAPHRAGM AND HOW THAT
AFFECTS PERISTALSIS IN THE GUT.
ASK ANYBODY WHO HAD A COUGH, CAN
YOU SEPARATE MUSCULOSKELETAL
FROM RESPIRATORY? IF YOU GET
THE RIBS OR DIAPHRAGM SORE FROM
THE COUGH, IT'S HARDER TO HEAL
FROM THE RESPIRATORY INSULT OF
THE INSTEAD OF THINKING OF SILOS
WE THINK OF MORE OF AN
INTERMESHING BETWEEN THE SYSTEMS
AND MUSCULOSKELETAL SYSTEM AND
HOW WE ACCESS THROUGH
MUSCULOSKELETAL.
SO I'M VERY EXCITED TO HEAR THAT
THAT'S -- THAT THE THOUGHT WE'VE
HAD FOR A LONG TIME IS GAINING
SOME MORE MAINSTREAM LEGITIMACY.
>> IT HAS A WAYS TO GO.
I WANT TO APOLOGIZE.
I SAID IT'S MISSING, I MEANT
FROM CONVENTIONAL SCHOOLS BUT
CERTAINLY NOT FROM OSTEOPATHIC
SCHOOLS.
SO WE HAVE A LOT TO LEARN FROM
YOU ALL.
>> I YOU WANT TO ADDRESS HOW TO
EDUCATE.
ANOTHER WAY IS TO MAYBE BRING
STUDENTS TOGETHER FROM DIFFERENT
DISCIPLINES.
YOU KNOW, I ACTUALLY TEACH AND
INTERDISCIPLINARY COURSE ON PAIN
IN UNIVERSITY OF MINNESOTA WHERE
WE INTEGRATE NURSES,
PSYCHOLOGISTS, THEY HAVE LEARNED
ABOUT APPROACHES TO PAIN, A FUN
WAY TO THINK ABOUT THIS MORE.
THEN MAYBE, YOU KNOW, IN TERMS
OF THE RESEARCH THAT WE DO,
MAYBE THERE'S SOMETHING IN TERMS
OF SOME RFAs THAT COME OUT
THAT REQUIRE SOME OF THIS
INTERDISCIPLINARY COLLABORATION,
YOU KNOW, TO REALLY -- A LITTLE
BIT MORE PROVOKING OR, YOU KNOW,
ENCOURAGEMENT BECAUSE I THINK WE
ALL DO HAVE DIFFERENT
PERSPECTIVES BUT WE CAN DO IT
WITHIN THE DISCIPLINE, A WHOLE
SYSTEM APPROACH, BUT THERE'S
SOMETHING REALLY UNIQUE AND
MAYBE WILL HELP US GET A LITTLE
BIT FURTHER IF WE CAN BRING
DIFFERENT DISCIPLINES TOGETHER.
>> THANK YOU.
OTHER QUESTIONS, COMMENTS FROM
COUNCIL?
>> IF I CAN POSE A QUESTION.
HELENE, YOU'VE OUTLINED THIS
AMBITIOUS AND EXCITING RESEARCH
PROGRAM.
AND I WOULD BE INTERESTED IN
HEARING OR UNDERSTANDING HOW YOU
WOULD APPROACH THIS TO DEVELOP
THE EVIDENCE BASE, TO INFORM OUR
UNDERSTANDING, ULTIMATELY
IMPLEMENTATION, ET CETERA.
AND, YOU KNOW, IS THERE -- ARE
THERE EXAMPLES YOU CAN POINT TO
WHERE THESE SORTS OF PROBLEMS
WERE TACKLED SUCCESSFULLY, AND
ACQUIRED, YOU KNOW, INFORMED
KIND OF UNDERSTANDING ABOUT
WHOLE BODY HEALTH AND THEN
IMPLEMENT IT.
DO YOU HAVE A ROAD MAP OR WILL
THIS BE A FIRST OF ITS KIND SORT
OF STUDY?
I'D LOVE TO HEAR A LITTLE BIT
MORE FROM YOUR PERSPECTIVE.
>> GREAT QUESTION.
FIRST OF ALL, WE'LL HAVE TO DO
IT TOGETHER, RIGHT?
I MEAN, AND I THINK THE FACT
THAT WE'RE SO GRATEFUL THAT
NIAMS DECIDED TO TAKE THE BULL
BY THE HORNS AND TACKLE THE VERY
FIRST QUESTION, FUNDAMENTAL ONE,
OF, YOU KNOW, MAPPING THE
SENSORY NEURONS, I THINK THAT
THAT WAS SUCH AN IMPORTANT THING
TO DO.
AND, YOU KNOW, BECAUSE NIAMS IS
THE LEAD ON IT BUT ALSO OF
COURSE WITH THE COLLABORATION OF
NINDS AND NIDCR AND NCCIH AND
NIBIB IS ALSO COLLABORATING.
WE NEED TO GET OUR HEADS
TOGETHER AND SAY, OKAY, LET'S
START WITH THAT.
YOU KNOW, LET'S START WITH
UNDERSTANDING WHERE THE SENSORY
NERVES ARE.
AND THEN HOW DO THEY CHANGE IN
THE PRESENCE OF DISEASE GOING
TOWARDS DISEASE, AND THEN ONCE
WE HAVE ESTABLISHED A KIND OF
SET OF MEASURES THAT WE COULD
USE TO FOLLOW THAT, THEN PERHAPS
GO TO BACPAC AND SEE HOW THIS
COULD BE -- THE TYPE OF MODELING
YOU'VE DESCRIBED, THAT IS YOU'RE
LEARNING SO MUCH AT NIAMS ABOUT,
YOU KNOW, ABOUT HOW TO INTEGRATE
ALL THESE MEASURES INTO A
COMPREHENSIVE MODEL THAT COULD
BE TESTED.
AND THEN YOU CAN SEE, WELL,
OKAY, HOW CAN YOU THEN TRY TO
REVERSE THE DIRECTION OF THIS
PATHOPHYSIOLOGY WITH AN
INTERVENTION?
I SEE -- FIRST ANATOMY, YOU
KNOW, BIOMARKERS, MODELS, AND
THEN INTERVENTIONS.
THAT'S KIND OF HOW I THINK WE
COULD SORT OF ALL GET TOGETHER
AND ATTACK THIS PROBLEM.
DOES THAT MAKE SENSE?
>> WELL, YEAH, ABSOLUTELY.
I ALSO HAVE BEEN THINKING I
THINK THAT BETWEEN BACPAC AND
THE MYOFASCIAL PAIN EFFORT AND
RE-JOIN, THEY WILL ALL BE
MUTUALLY INFORMATIVE.
AND BENEFIT FROM, YOU KNOW,
FINDINGS AND OBSERVATIONS AND
MODEL DEVELOPMENT IN THE OTHERS.
SO I SEE THOSE THREE EFFORTS AS
BEING MUCHLY INFORMATIVE AND
COMPLEMENTARY.
>> YEAH, YEAH.
AND THE FACT THAT, YOU KNOW, I
WAS -- I THINK THAT ALL THESE
THINGS ARE GOING TO PLUG IN.
FOR EXAMPLE, THINKING MYOFASCIAL
PAIN, EVERYTHING WE LEARN ABOUT
MYOFASCIAL PAIN WILL INFORM BACK
PAIN, FOR SURE.
AND EVERYTHING THAT WE LEARN
ABOUT MYOFASCIAL PAIN WILL
INFORM JOINT PAIN.
BUT I DON'T THINK IT'S GOING TO
STOP THERE.
I THINK THAT EVERYTHING WE LEARN
ABOUT BACK PAIN THROUGH THE
EXERCISE OF BACPAC WILL THEN
HELP US TO OPERATIONALIZE I HOW
WE THINK ABOUT ALL THESE VARIOUS
FACTORS THAT PLAY INTO THIS
BECAUSE IT'S COMPLICATED.
AND I REALLY AM DELIGHTED BACPAC
IS INCORPORATING PSYCHOSOCIAL
ASPECTS, WHICH IS KEY.
YOU'VE ALREADY GOTTEN A REAL
GOOD START ON THIS.
YEAH, I THINK THAT WITHIN -- YOU
KNOW, IT WON'T GO IN A STRAIGHT
LINE FOR SURE BUT ... IT WOULD
BE NICE TO SEE WHERE THIS ALL
GOES.
KAREN?
>> SO IF I THINK ABOUT THIS,
HELENE, NORMALLY HE START AT THE
LOWEST LEVEL, ANATOMY BETTER
WORKED OUT, MOVE UP ONE LEVEL,
MIGHT GO BACK AND GET A LITTLE
MORE ANATOMY BECAUSE YOU LEARNED
SOMETHING NEW.
YOU KNOW, ADD SYSTEMS BIOLOGY,
BLAH, BLAH, BLAH, EVENTUALLY GET
INTERVENTION URGES ENTER.
OF VENGES.
SOME -- INTERVENTION.
SOME OF US WILL BE RETIRED OR
DEAD BY THIS TIME.
AS WE DEVELOP INTERVENTIONS MORE
BLACK-BOXY OR BASED ON BEST
EVIDENCE NOW ARE THERE THINGS WE
CAN DO THAT CAN HELP INFORM THIS
THING THAT'S COMING BEHIND TO
NAIL THINGS DOWN FURTHER, ARE
THERE CLINICAL STUDIES OR WAYS
OF COLLECTING OBSERVATIONS THAT
WILL FACILITATE EVERYTHING
QUICKER?
>> I I'VE GOT TO CHIME IN.
GREAT QUESTION, KAREN.
I'M ON THE BACPAC STUDY I'M PART
OF THE BEST TRIAL DOING BRAIN
IMAGING, DOING ALL TYPES OF
INTERVENTIONS.
ONE OF THE INTERESTING THINGS
THAT DR. CRISWELL WAS SAYING
ABOUT THE BACPAC STUDY IS WE'RE
DOING INTERVENTIONAL
PHENOTYPING.
IN ESSENCE WE'RE USING DIFFERENT
INTERVENTIONS, NOT AS A WAY TO
SAY ONE INTERVENTION IS BETTER
THAN ANOTHER BUT SAY CAN WE USE
THE INTERVENTION AS A PROBE TO
SEE WHICH SPECIFIC PATIENT
RESPONDS TO THAT INTERVENTION?
AND THEN GO BACK TO THE ANATOMY
AND BIOMARKERS AND SAY, OH,
WELL, ALL THE PEOPLE THAT
RESPONDED WELL TO, SAY,
ACUPRESSURE, THEY ALL HAD THIS
TYPE OF PHENOTYPE BASED ON THEIR
BRAIN STRUCTURE OR THEIR
BIOPSIES OR GENETICS OR
PROTEOMICS, ET CETERA, A WAY TO
FAST TRACK RATHER THAN BUILDING
FROM FOUNDATION UP, FROM ANATOMY
UP, TO GO TO TREATMENTS, AND
GIVE US INFORMATION GOING
BACKWARDS.
I THINK THAT APPROACH OF GOING
FORWARD AND BACKWARD AT THE SAME
TIME I THINK IS REALLY
REMARKABLE FOR BACPAC AND I'M
HAPPY TO BE PART OF THAT STUDY,
LOVE WORKING AT U OF M WITH DR.
KLAW.
THOUGHT I WOULD MAKE THAT PLUG.
>> I DON'T SEE US DOING
METABOLOMICS UNLESS IT'S REALLY
EASY, QUICK AND CHEAP, CERTAINLY
NOT BRAIN IMAGING AT THIS POINT
IN TIME IN THE CLINIC FOR
ORDINARY PATIENTS.
SO, I PRESUME THAT ONCE YOU'VE
DONE THAT YOU'LL NEED SOME SORT
OF BIOMARKERS THAT ARE MUCH
EASIER THAT GIVE YOU A HINT OF
WHAT YOU WOULD FIND IF YOU DID
THESE MORE EXTENSIVE AND
EXPENSIVE STUDIES.
>> YEAH, I DON'T KNOW ABOUT
BRAIN IMAGING PER SE BECAUSE THE
FIELD MOVES QUICKLY, WHAT WE'RE
DOING IN THE SCANNERS COULD BE
CLINICALLY RELEVANT IN A COUPLE
YEARS.
I FEEL LIKE BRAIN IMAGING A
MIGHT BE ABLE TO BE CLINICALLY
MEANINGFUL.
WE PUT PEOPLE IN SCANNERS FOR
ALL SORTS OF THINGS, AND WE DO
IT FOR ALL SORTS OF OTHER
CONDITIONS.
SO, WHY COULDN'T WE ALSO DO THE
BRAIN SCANNING FOR MECHANISM OF
PAIN WHICH IS A SENSORY
PHENOMENON?
>> IN THE REAL WORLD, IT'S VERY
EXPENSIVE.
IN OUR HEALTH CARE SYSTEM AT
LEAST IT'S HARD TO GET IN AND
THAT KIND OF THING.
YOU KNOW, I DON'T SEE THIS MAYBE
BEING SOMETHING AVAILABLE,
FEDERALLY QUALIFIED HEALTH
CENTERS OR OTHER THINGS LIKE
THAT.
I THINK THERE ARE SOME PRACTICAL
ASPECTS.
MAYBE THE SCANNERS WILL BE THE
SORT OF THING THAT DOCTORS HAVE
IN THEIR OFFICES SOMEDAY.
>> YOU KNOW, I WISH I COULD
RECALL MORE OF THE DETAILS BUT I
PARTICIPATED IN A REALLY
INTERESTING CONVERSATION RELATED
TO BACPAC WHERE STAKEHOLDERS,
NOT JUST THOSE WHO MAKE
DECISIONS ABOUT WHAT CAN ARE
COVERED, ARE WEIGHING IN EARLY
ON.
YES, IMAGING IS EXPENSIVE, BUT
WHEN YOU CONSIDER THE TOTALITY
OF COST, YOU KNOW, IN MANY
DIMENSIONS FOR FAILED AND
INADEQUATE TREATMENT OF CHRONIC
CONDITIONS, YOU KNOW, IT MIGHT
MAKE SENSE TO, YOU KNOW, INVEST
IN SOME EXPENSEIVE PHENOTYPING
UP FRONT BECAUSE OF THE SAVINGS
IN TERMS OF DOLLARS AND OUTCOMES
AND STUFF, ET CETERA.
I WAS PLEASED THAT THAT
PERSPECTIVE OF FOLKS WHO WOULD
BE INVOLVED IN ULTIMATELY
APPROVING USE OF THESE SORTS OF
THINGS IN DIFFERENT CLINICAL
SETTINGS WERE BEING BROUGHT INTO
THE BACPAC CONVERSATION EARLY
RATHER THAN LATER.
IT WAS A REALLY GOOD STRATEGY.
>> RIGHT.
THAT'S ONE OF THE REASONS I
THINK FROM THE MYOFASCIAL PAIN
INITIATIVE ONE OF THE HYPOTHESES
BEHIND THIS WHOLE THING IS THAT
NOBODY HAS REALLY IMAGED THOSE
TISSUES BEFORE.
WE DON'T HAVE MEASUREMENTS TO
LOOK AT MUSCLES, CONNECTIVE
TISSUE, AND FASCIA TOGETHER.
ONE OF THE REASONS PEOPLE SAY
IMAGING IS TOO EXPENSIVE,
DOESN'T CORRELATE WITH ANYTHING,
WELL, YOU KNOW, WE MAY HAVE TO
HUNT AROUND, KEEP GOING UNTIL
YOU FIND THE RIGHT THING TO LOOK
AT.
YOU HAVEN'T NECESSARILY LOOKED
AT EVERYTHING YET.
WE SHOULDN'T GET DISCOURAGED
JUST BECAUSE, YOU KNOW, WE
HAVEN'T DONE IT YET.
I WOULD SAY IT'S REALLY
IMPORTANT TO THINK ABOUT THE
KINDS OF PHENOTYPING THAT WE ARE
MISSING.
WHAT ARE THE GAPS IN OUR WAYS TO
THINK ABOUT THE BODY, TO LOOK AT
IT, TO MEASURE IT?
WE STILL HAVE A LOT TO LEARN.
>> WE MAY BE ABLE TO IDENTIFY
CORRELATES OF MORE EXPENSIVE AND
INTENSIVE PHENOTYPING TOO THAT
WOULD BE OBVIOUSLY GREAT
UTILITY.
>> EXACTLY.
SOMETHING AS SIMPLE AS
PALPATION, RIGHT?
YOU KNOW, YOU LOOK AT A SKILLED
MANUAL THERAPIST, THEY FEEL
THINGS WITH THEIR HANDS THAT WE
KNOW WHAT THEY ARE FEELING BUT
THERE'S NO OBJECTIVE MEASUREMENT
CORRELATED WE DON'T HAVE GOOD
WAYS TO IMPLEMENT OR ACT ON IT
THAT IS SCIENTIFIC, RIGHT?
BUT ONCE YOU HAVE THAT, THEN YOU
CAN GO BACK TO THE PALPATION
AND, YOU KNOW, IT'S VERY CHEAP
TO PALPATE.
YOU ABOUT IF YOU HAD WAYS YOU
COULD USE THE ULTRASOUND OR MRI,
WHATEVER, UNDERSTAND WHAT IT IS
YOU'RE PALPATING THEN I THINK IT
WOULD START TO GO BACK, FIND
CHEAPER WAYS TO -- YEAH.
>> WE'VE EXPERIMENTED WITH THAT.
OH, I'M SORRY.
>> I'M SORRY.
>> THERE'S A DEVICE CALLED
BUTTERFLY ULTRASOUND, I DON'T
KNOW IF ANYBODY HEARD OF THIS.
ULTRASOUND PROBE THAT PLUGS INTO
YOUR PHONE.
DOWNLOADED APP AND YOU CAN LOOK
AT IT.
SO WE'VE PLAYED AROUND WITH
THOSE IN OUR LABS FOR FIRST-YEAR
STUDENTS LOOKING AT ACHROMIUM
PROCESS, GREATER TUBEROSITY AND
SEE THEIR FINGER COMING DOWN ON
THE DEVICE.
UNFORTUNATELY INCREDIBLY TIME
CONSUMING BUT RESULTS IN A LOT
OF LIGHT BULB MOMENTS.
I'M ACTUALLY ON THE THING.
COMPLICATED STRUCTURES, IT'S
HARDER TO DO THAT BUT WE'VE
EXPERIMENTED AND IT DOES SEEM TO
GREATLY INCREASE STUDENTS'
CONFIDENCE THAT THEY ARE ON WHAT
THEY THINK THEY ARE ON.
>> I JUST WANT TO SAY SOMETHING,
ADD SOMETHING SIMILAR.
PALPATION IS A SKILL THAT IS
NEGLECTED IN OUR MEDICAL SCHOOLS
COMPARED TO ULTRASOUND AND
IMAGING STUDIES.
SO I WANT TO GO BACK TO THE
SUGGESTION, EDUCATION IS
IMPORTANT.
HANDS-ON EDUCATION WITH
PALPATION.
>> DR. DELITTO?
>> I'LL TRY NOT TO BE
CONTROVERSIAL.
I DON'T SEE PALPATION COMING
BACK TO MEDICAL SCHOOLS.
IN STUDIES WE'VE DONE, YOU KNOW,
ONCE YOU GET INTO THE PRAGMATIC
NATURE OF TRIALS AND TRY TO GET
PRIMARY PHYSICIANS TO TOUCH A
PATIENT, WITHOUT A STETHOSCOPE,
IT'S PRETTY DIFFICULT.
SOME OF OUR STUDIES WITH KNEE
O.A., FOR EXAMPLE, YOU KNOW,
JUST THE CLINICAL DIAGNOSIS OF
OSTEOARTHRITIS REQUIRES
PALPATION FOR PAIN OF THE KNEE,
AND WE COULDN'T GET PRIMARY CARE
PHYSICIANS TO DO THAT.
SO I DON'T KNOW, I THINK IT'S A
LOST ART, YOU KNOW, WITH REGARD
TO PHYSICIANS.
BUT IT'S WHAT WE DO IN MOST OF
OUR OTHER PROFESSIONS.
P.T., CHIRO, ALL OF THEM.
I'M WONDERING IF WE SET THE BAR
HIGH TRYING TO OBJECTIFY,
GETTING TO POINT WHEN ARE WE
READY FOR COMPARATIVE
EFFECTIVENESS TRIAL?
EVERYBODY WANTS TO GET THE
INTERVENTION DOWN, WANTS TO HAVE
THE INTERVENTION SOLELY BASED ON
SOME BASIC WORK, MECHANISTIC
WORK, BUT THAT'S NOT WHAT WE'RE
GOING UP AGAINST.
I HAVEN'T SEEN THE SURGERY, AND
SO FORTH.
THEY HAVE NOT BEEN SUBJECTED TO
THAT LEVEL OF SCRUTINY.
AND EVERY DAY PEOPLE ARE GETTING
UNNECESSARY PROCEDURES DONE TO
THEM.
I JUST KEEP REMINDING PEOPLE OF
THAT.
AND UNNECESSARY PROCEDURES,
WELL, IT'S ALMOST -- SOMETIMES
IT'S ALMOST "60 MINUTES"
MATERIAL.
I'M THROWING ALL THAT OUT.
>> YOU WERE SUCCESSFUL IN BEING
PROVOCATIVE, TONY.
NOW FOUR PEOPLE HAVE COMMENTS.
>> WHAT'S OUR STOP TIME TO MAKE
SURE EMMELINE HAS TIME TO GIVE
HER PRESENTATION?
>> WE'VE STILL GOT ANOTHER 20
MINUTES.
>> OKAY.
THANKS.
>> EXCELLENT.
I WON'T TAKE ALL THAT.
I AGREE WITH YOUR STATEMENTS
THAT A LOT OF PHYSICIANS ARE NOT
TRAINED TO TOUCH.
I THINK THIS IS, AGAIN, ANOTHER
PLACE THAT OSTEOPATHIC
PHYSICIANS SHOULD BE REALLY
BROUGHT IN AND WE CAN SHINE
BECAUSE FROM THE FIRST WEEK OF
OSTEOPATHIC MEDICAL SCHOOL, OUR
STUDENTS ARE TRAINED TO TOUCH.
AND INCORPORATING ORTHOPEDIC
EXAM INTO AN OSTEOPATHIC
STRUCTURAL EXAM IS WHAT THEY ARE
TRAINED TO DO AND WHAT THEY ARE
TESTED ON DOING, AND WHAT WE --
THE FEEDBACK WE GET FROM
RESIDENCIES THAT OUR STUDENTS DO
IN PRACTICE PRESENT DIFFERENTLY
BECAUSE THEY DON'T HAVE THAT
FEAR OF TOUCH, BECAUSE THEY HAVE
LEARNED HOW TO USE THEIR HANDS.
AND I UNDERSTAND THAT IN A LOT
OF WAYS IT'S LESS VALIDATED THAN
SOME IMAGING TECHNIQUES AND SOME
OTHER SORT OF STUDY TECHNIQUES
BUT THERE'S A LOT OF OUR PATIENT
POPULATION IN THIS COUNTRY THAT
DON'T HAVE ACCESS TO THOSE
ADVANCED IMAGING TECHNIQUES OR
CAN'T AFFORD IT.
THAT'S WHERE TEACHING A
PHYSICIAN AT THE POINT OF CARE
HOW TO PALPATE RELIABLY TO WHAT
DEGREE WE CAN AND MAKING A
DIFFERENCE AT THAT POINT IS
CRUCIAL, AS WE CONTINUE TO GROW
OUR AGING POPULATION AND HAVE
MORE AND MORE MUSCULOSKELETAL
ISSUES.
THIS IS WITHIN THE NEXT FOUR OR
FIVE YEARS D.O.s WILL BE ONE
IN TEN OF THE PHYSICIANS IN THIS
COUNTRY.
WE HAVE A HUGE AND GROWING
POPULATION OF PHYSICIANS THAT
ARE TRAINED HOW TO DO THEIR
HANDS, HOW TO USE THEIR HANDS.
AND SO PERHAPS WE NEED TO BE
LOOPING THAT IN THE CONVERSATION
A BIT MORE.
THERE'S SEVERAL ORGANIZATIONS
THAT TEACH COURSES ON PALPATORY
DIAGNOSIS AND PALPATORY
TREATMENT THAT ARE OPEN TO
P.A.s, NPS, M.D.s, PTs, ET
CETERA, NOT THAT PTs -- THEY
ARE USUALLY PRETTY GOOD AT THAT
ANYWAY, BUT WE'RE ANXIOUS TO
TEACH AND -- I'LL STOP THERE.
>> THANK YOU.
DR. HARRIS?
>> I'LL JOIN IN AND STRESS THAT
TOUCH IS CRITICAL.
WHAT KIND OF PROFESSION ARE WE
IF WE'RE HEALERS AND WE'RE NOT
TOUCHING, WE DON'T WANT TO TOUCH
OUR PATIENTS?
THAT SETS UP A DYNAMIC THAT GOES
COUNTER TO THE HEALING PROCESS.
AS AN ACUPUNCTURIST, I LEARNED
TO DO ACUPRESSURE WITH MY HANDS
AND FINGERS.
I SEE PATIENTS, AFTER NEEDLING
I'LL DO ACUPRESSURE, THAT
PROVIDES A CONNECTION.
I THINK IT'S SO IMPORTANT.
ONE OF THE THINGS I WAS THINKING
ABOUT IN TERMS OF WHAT HELENE
WAS TALKING ABOUT, JOINTS AND
MYOFASCIAL TISSUES AND
EVERYTHING, SOMETHING THAT
HASN'T REALLY BEEN LOOKED AT
FROM THE RESEARCH PERSPECTIVE IS
GUASA AS A FORM OF HEALING.
THE TOUCH IN THAT PROCEDURE
COULD BE STUDIED.
I'LL PUT A PLUG IN FOR NOTICE OF
INTENT OR SOME INTEREST IN
CUPPING AND GUASA AS ADDITIONAL
TOUCH THERAPIES THAT GET AT THE
MYOFASCIAL TISSUE.
>> I RECENTLY SAW A PICTURE OF,
ULTRASOUND PICTURE WHERE YOU PUT
THE CUP, SUCTION, TWO LAYERS OF
FASCIA THAT WERE ADHERENT BECAME
SEPARATED.
I DIDN'T THINK THAT CUPPING
COULD DO THAT.
I SAW IT WITH ULTRASOUND, VERY
INTERESTING TO SEE.
>> WE NEED MORE RESEARCH.
>> WE DO.
I AGREE, YEAH.
LET'S SEE.
>> HI.
I HAVE A POSITIVE COMMENT AND
ECHO TONY'S CAUTIONARY TALE.
I HAVE A DAUGHTER WHO IS A
THIRD, GOING INTO FOURTH YEAR AT
SINAI, AND IT'S ONE THING TO
TALK ABOUT TOUCH IN PRIMARY
CARE, TOUCH IN MEDICINE WHICH I
THINK IS NOT OUT OF FAVOR, THE
IDEA OF TOUCH OF COMMUNICATION,
WHETHER IT'S A HANDSHAKE OR
TAKING A PULSE OR WHATEVER.
BUT THE IDEA OF PHYSICIANS, NOT
OSTEOPATHIC, BEING TRAINED IN
WHICH THE LEVEL OF PALPATION
COULD BE DIAGNOSTIC, NOBODY
SHOULD PURSUE THAT ROAD UNLESS
THEY WANT TO BE BANGING THEIR
HEAD AGAINST THE WALL.
THEY ARE GETTING EQUIPPED WITH
HAND-HELD ULTRASOUNDS, IT'S WHAT
THEY WANT FOR DIAGNOSIS.
I WANT TO THROW IN THAT REALITY
CHECK IN RELATION TO ALLOPATHIC
MEDICAL STUDENTS.
I WANT TO ECHO WHAT RICK SAYS
AND EXPAND.
THE WHOLE DISCIPLINE OF
ACUPRESSURE AND WHAT'S HAPPENING
IN THE TISSUES WITH ACCUPRESSURE
IS ALSO UNDERSTUDIED, FROM OUR
POINT OF VIEW DURING THE
PANDEMIC WHERE WE PIVOTED FROM
LOTS AND LOTS AND LOTS OF
IN-PERSON TREATMENT TO LOTS AND
LOTS OF TEACHING PEOPLE
VIRTUALLY HOW TO DO ACCUPRESSURE
ON THEMSELVES, AND THE KIND OF
FEEDBACK WE'VE GOTTEN ABOUT
EFFECTIVENESS OF THAT TECHNIQUE
IN TERMS OF EXPANDING ACCESS TO
THE BENEFITS, SOME BENEFITS OF
ACUPUNCTURE I'D LIKE TO THROW IN
ACCUPRESSURE TECHNIQUES INTO THE
MIX OF WHAT'S HAPPENING WITH
MANUAL THERAPIES, THAT WOULD BE
FANTASTIC.
VERY RELEVANT.
>> THANK YOU.
DR. MEHLING?
YOU'RE ON MUTE.
>> ACCUPRESSURE POINTS AND
TRIGGER POINTS ARE OFTEN
OVERLAPPING, 50% THE SAME.
AT UCSF WE ACTUALLY HAVE FOR 14
YEARS TAUGHT ABOUT 10% OF
MEDICAL STUDENTS MASSAGE, AND
THEY LEARN HOW TO TOUCH TRIGGER
POINTS AND HOW TO FEEL IT.
IT'S A MINORITY, I TOTALLY
UNDERSTAND TONY'S FRUSTRATION
AND BEN'S, BUT INCREASING
INTEREST IN INTEGRATIVE MEDICINE
AMONG MEDICAL STUDENTS.
THEY WANT TO DO SOMETHING WITH
MASSAGE, FOR EXAMPLE.
AND SO IT'S ONE OF THE SOUGHT
AFTER ELECTIVES AT UCSF.
>> THANK YOU.
DR. SHERMAN?
>> JUST TO ADD SOME CONTEXT TO
THE PLUG FOR UNDERSTANDING SOME
OF THED ED E ADJUNCTIVE, WE ASK
ACUPUNCTURISTS AT EVERY VISIT IS
THERE SOMETHING YOU WISH YOU
COULD HAVE DONE AND THEY TELL US
FOR THE MOST PART, AND THEY WANT
TO DO ELECTRICAL STIMULATION.
MY QUESTION WOULD BE, OKAY, IF
WE KNOW WHAT ACUPUNCTURE NEEDLES
DO, WHAT HAPPENS WHEN YOU ADD
ELECTRICITY ON IT?
THEY WANT TO USE HEAT.
BOTH REGULAR AND MOXA, MAYBE
THERE ARE STUDIES THAT HAVE
SHOWN WHAT THAT CAN DO BUT IF
THERE AREN'T, THERE SHOULD BE.
CUPPING IS COMMON, LESS FOR
TUENA AND GUASHA, IT WOULD BE
FUN TO DO SOMEWHERE YOU FIGURE
OUT HOW TO MEASURE WHAT HAPPENS
WHEN YOU DO MULTIPLE OF THESE
THERAPIES.
JUST AGAIN TO PROVIDE A KIND OF
BIOLOGICAL BASIS FOR WHAT IT IS
THAT ACUPUNCTURISTS DO SO THAT
THESE FULL BODY TREATMENT CAN BE
STUDIED.
YOU KNOW, WE DON'T KNOW WHETHER
IT'S BETTER OR NOT BECAUSE NO
ONE HAS LOOKED AT IT.
>> THANK YOU, DR. SHERMAN.
A HAND WENT UP AND DOWN.
DID YOU WANT TO MAKE A COMMENT?
>> NO, JUST GIVING A THUMBS UP
TO SOMEONE PREVIOUSLY.
IT LOOKS THE SAME.
>> I'M LEARNING A LOT FROM THIS
DISCUSSION.
I REALLY APPRECIATE THE
OPPORTUNITY TO STAY THROUGH THE
NEXT SESSION.
>> WE'RE SO GLAD YOU WERE ABLE
TO STAY.
AS YOU SEE, IT'S VERY RICH.
I'M REALLY, YOU KNOW, CURIOUS
ABOUT HOW FOLKS AT NIAMS, YOU
KNOW, THINK ABOUT THINGS LIKE
MUSCULOSKELETAL PALPATION AND
OSTEOPATHIC TECHNIQUES AND
THINGS LIKE THAT.
IT'S INTERESTING TO SORT OF
THINK ACROSS OUR INSTITUTES
ABOUT QUESTIONS LIKE THAT.
IS THERE A WAY THESE CAN BE
TRANSLATABLE.
>> NEIGHBOR WE NEED A NIAMS AND
NICCH FOCUS GROUP.
>> A LOT OF WHAT WE ARE TALKING
ABOUT IN TERMS OF -- I MEAN OF
COURSE SO THIS IS THE
INTERESTING THING HERE, RIGHT?
FOR A LONG TIME, I WOULD SAY THE
LAST 20, 30 YEARS MAYBE, THE
PENDULUM HAS SWUNG IN THE DOMAIN
OF PAIN IT WENT INTO THE NERVOUS
SYSTEM, RIGHT?
IT STARTED IN PERIPHERAL TISSUES
IN THE '50s AND '60s, '70s
EVEN.
THEN SOMETHING HAPPENED, RIGHT?
ALL OF A SUDDEN PAIN JUST WENT
INTO THE BRAIN, JUST STAYED
THERE.
BRAIN, SPINAL CORD.
AND I THINK ONE OF THE THINGS
THAT WE WANT TO DO IS RECONNECT
THE BRAIN WITH THE REST OF THE
BODY IN TERMS OF PAIN
ESPECIALLY, ESPECIALLY WITH
MUSCULOSKELETAL PAIN.
I THINK THERE NEEDS TO BE ALL
THE EXPERTISE AND THAT'S WHY I'M
EXCITED ABOUT THIS RE-JOIN,
ESPECIALLY ABOUT THE INITIAL
MAPPING OF SENSORY NEURONS THAT
NIAMS IS LEADING BECAUSE -- IT'S
REALLY TAKING -- PUTTING IT BACK
WHERE IT NEEDS TO BE.
>> FIRST COMMENTS YOU MADE
DURING AN EARLY DISCUSSION, YOU
KNOW, I THOUGHT WAS REALLY
INTERESTING, HAS HELPED DRIVE
THIS WHOLE EFFORT, SO, YEAH,
REALLY INTERESTING OBSERVATION.
>> WE HAVE TWO MORE HANDS
RAISED.
DR. HARRIS AND DR. JEAN LOUIS.
>> I'LL CHIME IN QUICKLY.
SORRY TO TAKE UP TIME.
I DON'T THINK WE'RE GOING TO BE
DOING OURSELVES THE MOST FAVOR
WE CAN DO IF WE DESCRIBE THE
WHOLE PERSON WITHOUT HAVING
INTERVENTIONS THAT TARGET
MULTIPLE LEVELS AND MULTIPLE
AREAS, CONCURRENTLY, AT THE SAME
TIME, IN THE SAME INDIVIDUAL.
SO WHILE IT'S HELPFUL TO HAVE A
DEFINITION OF THE PATHOLOGY OF
THE DISEASE HEALTH CONTINUUM
WE'RE GOING TO GET FURTHER WITH
MULTIPLE TREATMENTS THAT
SYSTEMATICALLY GO AT MULTIPLE
LEVEL TEST SAME TIME RATHER THAN
JUST GOING FOR ONE.
>> COULDN'T AGREE MORE, YEP,
UH-HUH.
THAT'S WHAT WE TALKED ABOUT AT
OUR WORKSHOP.
>> DR. JEAN LOUIS?
>> THANK YOU.
I SHARE THE SKEPTICISM ABOUT
MEDICAL SCHOOLS BEING INTRODUCED
TO THE IDEA PALPATION IS
NECESSARY.
I HAVE GONE TO SOME DISASTER
PREPAREDNESS SESSIONS, WE TALK
ABOUT THAT.
SOMETIMES THAT'S ALL YOU HAVE.
IF IT'S SUCH AN IMPORTANT TOOL
AND IT'S NOT BEING TAUGHT IN
MEDICAL SCHOOL, MAYBE WE CAN
HAVE TRAINING PROGRAMS, SUMMER
INSTITUTE OF THE TIME PEOPLE CAN
COME FOR A COUPLE WEEKS TO
LEARN, I'M SURE A LOT OF
STUDENTS MIGHT BE INTERESTED.
>> WE'VE ALL BEEN DEPRIVED OF
PHYSICAL CONTACT FOR THE LAST
TWO YEARS, YOU KNOW.
MAYBE WHEN PEOPLE CAN START TO
BE IN EACH OTHER'S PRESENCE
AGAIN PERHAPS TOUCHING ANOTHER
HUMAN BEING MIGHT INCREASE ITS
RELEVANCE.
>> DR. LANGEVIN, THE COURSE I
SPOKE OF THAT IS THE
INTRODUCTION TO PALPATION AND
MANUAL MEDICINE, WOULD IT BE
OKAY IF I PUT A LINK TO THAT IN
THE CHAT?
>> SURE.
THANK YOU.
WONDERFUL.
>> ANY OTHER QUESTIONS OR
COMMENTS BY COUNCIL MEMBERS OR
BY DR. CRISWELL AND LANGEVIN?
>> WE'LL GIVE YOU THE LAST
WORD, LINDSEY.
>> THANK YOU FOR A REALLY
INTERESTING CONVERSATION.
I LEARNED A LOT AND I'M LOOKING
FORWARD TO SEEING HOW THESE
PROJECTS UNFOLD.
I THINK THEY ARE COVERING REALLY
IMPORTANT GROUND NOT ADDRESSED
IN OTHER WAYS.
THANK YOU FOR THE OPPORTUNITY.
LOOKING FORWARD TO CONTINUING
THE CONVERSATION.
>> WELL, THANK YOU FOR TAKING
TIME OUT OF YOUR BUSY DAY.
I KNOW HOW BUSY YOU ARE.
THANK FOUR SPEND -- THANK YOU
FOR SPENDING THE TIME WITH US.
>> MY PLEASURE.
ENJOY THE REST OF YOUR
AFTERNOON.
>> WE'RE GOING TO NOW -- DR.
EMMELINE EDWARDS WILL GIVE THE
TALK WE WERE SCHEDULED ON THE
AGENDA BEFORE LUNCH, BECAUSE WE
GOT ENGROSSED IN ALL THESE OTHER
THINGS WE'RE SHIFTING.
WE HAVE TIME FOR EMMELINE TO
GIVE HER PRESENTATION ON THE
FUNDING OPPORTUNITY
ANNOUNCEMENTS THAT NCCIH IS
INVOLVED WITH RELATED TO PAIN
RESEARCH.
DR. EDWARDS?
>> JUST A MINUTE.
I'M TRYING TO PUT IT INTO VIEW.
OOPS.
I'M TRYING TO PUT IT INTO VIEW
MODE.
I DON'T SEEM TO BE ABLE.
>> CAN DO YOU THE SLIDE SHOW
WHERE YOU'RE AT, SLIDE IT TO THE
RIGHT WHERE THE SLIDE SHOW ICON
IS?
>> I GOT IT, YEAH.
>> TRY THAT.
>> YEAH, THANKS.
OKAY, SO, THANK YOU.
I'M GOING TO TRY TO DO THIS VERY
QUICKLY TO JUST GIVE YOU A VERY
QUICK OVERVIEW OF THE PLANS THAT
WE HAVE IN PLACE TO EXPAND OUR
PAIN PROGRAM TO ADDRESS GAPS IN
EXISTING PORTFOLIO AND LEVERAGE
THE OPPORTUNITIES THAT EXIST
ACROSS THE NIH AND OTHER FEDERAL
AGENCIES.
I SUSPECT MOST OF YOU HEARD THE
WORD "PAIN" FOR MOST OF THE DAY
BUT I WANT TO PUT WHAT I'M GOING
TO TALK ABOUT IN CONTEXT.
THIS IS DATA ACTUALLY FROM
PUBLICATION FROM TWO OF OUR
NCCIH STAFF, REALLY REMINDING US
MORE THAN 30% OF AMERICANS ARE
LIVING WITH SOME FORM OF CHRONIC
OR SEVERE PAIN AND MORE PEOPLE
LIVE WITH CHRONIC PAIN THAN
CANCER, HEART DISEASE, AND
DIABETES COMBINED.
ALSO WE'RE DEALING WITH
PREVALENCE OF DIFFERENT PROFILES
OF HIGH IMPACT CHRONIC PAIN IN
THE U.S., WITH LARGE PERCENTAGE
OF INDIVIDUALS REALLY HAVING
SEVERE LIMITATION OF THE
FUNCTION.
MOST OF YOU COULD HAVE MISSED
THIS RELEASE.
THIS OCCURRED DURING THE
HOLIDAY.
IT WAS RELEASED ON DECEMBER 27,
2021.
AND THIS WAS ACTUALLY NOTICE OF
INFORMATION THAT WAS PUT BY THE
I.C. DIRECTORS OF SEVEN
INSTITUTION ALERTING OF INTEREST
IN PAIN RESEARCH.
NOT ONLY RESEARCH BUT ALSO
TRAINING PROGRAMS TO BUILD A
MORE EFFECTIVE AND INTEGRATED
WORKFORCE IN PAIN RESEARCH.
THAT INTEREST SPANNED BASIC
RESEARCH ON PAIN CIRCUITS, PAIN
MECHANISM, UNDERSTANDING THE
BIOLOGICAL BASIS OF MULTIPLE
PAIN DISORDERS, AND ALSO
RESEARCH THAT WOULD IDENTIFY
RISK FACTORS FOR CHRONIC PAIN,
AS WELL AS AREAS OF INTEREST
INCLUDING HEALTH DISPARITY,
HEALTH EQUITY.
BUT I ALSO WANT TO PUT IT INTO
THE CONTEXT OF NCCIH, BECAUSE
ONE OF THE TOP TEN SCIENTIFIC
PRIORITIES THAT WE HIGHLIGHTED
IN OUR STRATEGIC PLAN WAS
COMPLEMENTARY AND INTEGRATIVE
MANAGEMENT OF PAIN.
AND SO OUR STRATEGIC PLAN WAS
RELEASED IN EARLY SUMMER 2021,
AND THEREFORE I CAN SAY THAT WE
WERE VERY MUCH AHEAD OF THE
CURVE BECAUSE WE HAD HIGHLIGHTED
MANY OF THOSE AREAS OF INTEREST
AS WELL.
PAIN MECHANISM AND PHENOTYPE,
OVERLAPPING CONDITION, HEALTH
DISPARITIES IN PAIN, EFFICACY
AND EFFECTIVENESS OF
COMPLEMENTARY APPROACHES, AND
UNDERSTANDING MULTI-SYSTEM
MECHANISM UNDERLYING EFFECT OF
OUR STRATEGIES.
IMPORTANTLY WE HAD RECOGNIZED
POTENTIAL OF LEVERAGING "HEAL"
AND TRANS-NIH AND TRANSAGENCY
PROGRAMS TO IDENTIFY THERAPEUTIC
BIOMARKERS FOR COMPLEMENTARY AND
INTEGRATIVE APPROACHES ON PAIN.
WE CONTINUE TO HAVE AN INTEREST
IN IMPROVED METHODS TO
INCORPORATE OUR APPROACHES TO
STANDARD CARE TO TREAT PAIN AND
DECREASE USE OF OPIOIDS.
SO I'M GOING TO HIGHLIGHT TWO
FUNDING OPPORTUNITY
ANNOUNCEMENTS CURRENTLY OPEN
THAT NCCIH HAS WORKED HARD TO
PUT OUT SOMETIME IN NOVEMBER.
FIRST OPPORTUNITY IS NOTICE OF
SPECIAL INTEREST FOR
ADMINISTRATIVE SUPPLEMENTS TO
NCCIH-FUNDED GRANTS.
THOSE ARE ONE-YEAR SUPPLEMENTS,
GRANTS HAVE TO HAVE AT LEAST 18
MONTHS LEFT IN THEIR LIFE CYCLE
TO BE ABLE TO ELIGIBLE FOR
SUPPLEMENT.
JUST ONE CAVEAT IS THAT IT HAS
TO BE WITHIN THE SCOPE OF THE
ORIGINAL PROJECT BUT THOSE --
THIS OPPORTUNITY ALLOWS
INVESTIGATORS TO SUBMIT THOSE
SUPPLEMENTS FOR ONE YEAR AND
THEY ARE REVIEWED BY OUR PROGRAM
STAFF.
SO THIS OPPORTUNITY IS STILL
OPEN UNTIL MAY OF 2022.
AND I WILL TELL YOU IN A MINUTE
AREAS OF FOCUS FOR THESE
OPPORTUNITIES.
WE ALSO HAVE A SECOND NOTICE OF
SPECIAL INTEREST, MORE FOCUSED
ON LONGER TERM RESEARCH GRANTS,
STANDARD R01, EXPLORATORY AND
DEVELOPMENTAL GRANT, ALSO OUR
PROFILES, THIS OPPORTUNITY
EXPIRES IN DECEMBER 2022.
LATER ON THIS AFTERNOON YOU'LL
HEAR CONCEPT CLEARANCE THAT WILL
FURTHER EXTEND THE TIMELINE OF
SUCH OPPORTUNITIES.
THE AREAS OF FOCUS FOR THESE TWO
IS HIGHLIGHTED IN THIS SLIDE,
THE EARLIER HELENE MENTIONED
SUCCESSFUL WORKSHOP IN JULY 2021
TO SICKLE CELL PAIN SO ONE OF
THE AREAS AND ONE RESEARCH GAP
IN OUR PORTFOLIO TO BETTER
UNDERSTAND RESEARCH ON PAIN
RELATED TO SICKLE CELL DISEASE.
AT THE WORKSHOP IT BECAME CLEAR
THAT WHILE THERE ARE, YOU KNOW,
IMPROVEMENTS IN TERMS OF
TREATMENT FOR SICKLE CELL, AT
LEAST THE VASCULAR ASPECT, WITH
STEM CELLS TRANSPLANTS AND ALSO
ARE GENE THERAPY, THE PAIN
ASSOCIATED WITH SICKLE CELL
CONTINUES IN MANY PATIENTS.
WE REALLY DON'T UNDERSTAND THE
MECHANISM OF HOW THAT HAPPENS.
SO THIS IS A GAP AREA THAT WE'RE
VERY MUCH INTERESTED IN.
WE ARE ALSO ENCOURAGING LOTS OF
BASIC AND MECHANISTIC
UNDERSTANDING OF MYOFASCIAL
PAIN.
YOU HEARD ABOUT DEVELOPMENT OF
THE WORKSHOP FOR FORCE-BASED
MANIPULATION, WE WANT TO
ENCOURAGE FUNDAMENTAL SCIENCE OF
FORCE-BASED INTERVENTION, TO
PREVENT OR MANAGE PAIN.
WE WANT TO FURTHER IDENTIFY
NOVEL THERAPEUTIC TARGETS OF
PAIN FOR NON-ADDICTIVE NATURAL
PRODUCTS.
AND WE WANT TO ENCOURAGE SCIENCE
TO ENHANCE PAIN MANAGEMENT.
YOU HEARD SOME OTHER ASPECT THIS
MORNING IN THAT DISCUSSION OF
THE HIGH PROGRAM PRIORITY,
CONCEPT IS REALLY TO EXPAND
MUSIC THERAPY TO ENHANCE PAIN
MANAGEMENT.
OF COURSE WE'RE INTERESTED IN
MULTI-COMPONENT PAIN MANAGEMENT
INTERVENTION DEVELOPMENT, AND
TRIALS OF COMPLEMENTARY
APPROACHES, DELIVERED REMOTELY
OR VIA MHEALTH, THE CURRENT HIGH
PRIORITY TOPICS THAT ARE
DELINEATED IN THE OPPORTUNITIES
THAT WE HAVE CURRENTLY OUT
THERE.
YOU'VE ALREADY HEARD THIS
FUNDING OPPORTUNITY ANNOUNCEMENT
WHICH EXPANDS OUR CURRENT
NIH-DoD-VA PAIN MANAGEMENT.
THERE'S STILL TIME, ON MARCH 26,
2022, IS THE DEADLINE.
OF COURSE, YOU'VE ALSO HEARD OF
THE RFA FOR MYOFASCIAL PAIN,
DEVELOPING QUANTITATIVE IMAGING
AND OTHER BIOMARKERS.
TIME IS LIMITED HERE BUT YOU
STILL HAVE TIME, FEBRUARY 11.
SICKLE CELL PAIN WE'VE
ALREADY -- WE HAD TWO
OPPORTUNITIES THAT ARE NOW
CLOSED BUT THEY WERE PRIMARILY
FOCUSED ON PRAGMATIC AND
INTERVENTION STUDIES, AND ALSO
ON EFFECTIVENESS RESEARCH.
SO NOW THAT IS WHY WE WANT TO
MOVE INTO BASIC AND MECHANISTIC
ASPECT AND CURRENT OPPORTUNITY
ON ADVANCING HEALTH EQUITY IN
PAIN MANAGEMENT THAT IS STILL
OPEN.
THERE ARE MULTIPLE EXAMPLES OF
NIH "HEAL" RFAs OUT THERE.
GO ON THE NCCIH WEB PAGE OR
DIRECTLY ON THE HEAL WEB PAGE,
THERE ARE CONSTANTLY NEW
ADDITIONS.
I'LL MENTION THERE ARE CURRENTLY
OPPORTUNITIES THAT ARE AVAILABLE
UNTIL APRIL AND JUNE, FOCUSED ON
ANALGESIC DEVELOPMENT,
TRANSLATIONAL RESEARCH,
DEVELOPMENT OF THERAPIES AND
TECHNOLOGIES THAT ARE FOCUSED ON
ENHANCING PAIN MANAGEMENT.
IF YOU'RE INTERESTED IN THOSE
AREAS, PLEASE VISIT THE WEBSITE
AND ACTUALLY GET THE SPECIFICS
ON THOSE RFAs.
YOU JUST HEARD THE WONDERFUL
PRESENTATION ABOUT THE RE-JOIN
INITIATIVE.
WE'RE REALLY EXCITED ABOUT THIS
AND HEARING HELENE'S VISION FOR
MOVING MOVING INTO WHOLE JOINT
HEALTH IS EXCITING AND WE'RE
LOOKING FORWARD TO FURTHER
DEVELOPING THOSE PROGRAMS.
THERE ARE A COUPLE HEAL RESEARCH
OPPORTUNITIES I'D LIKE TO
HIGHLIGHT, MORE FOCUSED ON
SERVICE DELIVERY.
THOSE ARE OUR NCCIH STAFF HAS A
VERY STRONG INFLUENCE INTO THE
DEVELOPMENT OF THOSE PROGRAMS,
THE FIRST ONE IS ACTUALLY ISSUED
THROUGH NIDA AS THE LEAD, IT'S
THE HEAL DATA2ACTION PROGRAM, A
SET OF FOUR INTERRELATED RFAs
TO PROMOTE SYNTHESIS IN REAL
WORLD APPLICATION OF EXISTING
DATA, ALSO GUIDING AND
MONITORING IMPROVEMENT IN
SERVICE DELIVERY TO PREVENT OR
TREAT OPIOID USE DISORDERS IN
PAIN.
ONE OF THE RFAs IS FOCUSED ON
INNOVATION RESEARCH GRANTS,
SUPPORTED BY THREE RESOURCE
CENTERS.
ONE WOULD BE FOCUSED ON
MODELING, THE OTHER ON ADOPTION
AND IMPLEMENTATION SCIENCE,
THIRD ON DATA INFRASTRUCTURE.
WENDY WEBER HAS BEEN
INSTRUMENTAL IN PARTICIPATING IN
DEVELOPMENT OF THOSE RESEARCH
FUNDING OPPORTUNITIES, END DATE
IS MARCH 11 THIS YEAR.
WE HAVE STILL IN THE SAME VEIN
IN TERMS OF SERVICE DELIVERY,
PETE MURRAY HAS BEEN INVOLVED IN
MANY OF THE DEVELOPMENT OF THESE
RFAs, ONE IS FOCUSED ON POLY
SUBSTANCE USE, INCLUDING BOTH
IMPROVEMENT OF SERVICE DELIVERY
TO THE REGULAR R01 MECHANISM,
AND ALSO FEASIBILITY TRIALS TO
IMPROVE PREVENTION AND
TREATMENT.
WE HAVE A COUPLE RFAs FOCUSED
ON SERVICES FOR INDIVIDUALS
RECEIVING MEDICATION ASSISTED
SERVICES.
AGAIN, EXPIRATION DATE MARCH
2022.
YOU CAN SEE THOSE RFAs HAVE
BEEN PUT IN PLACE IN ORDER TO
ENSURE THAT WE'RE READY IN CASE,
YOU KNOW, WE GET THAT LARGE
INFLUX OF MONEY.
BUT THERE'S PLENTY OF
OPPORTUNITIES FOR US TO BE ABLE
TO FULFILL THAT MANDATE.
FINALLY, WE ALSO HAVE A SET OF
RFAs FOCUSED ON HARM REDUCTION
POLICIES, DEVELOPMENT OF DATA
AND METHODS TO ADDRESS THE
URGENT NEED FOR OPIOID EPIDEMIC.
I WANT TO TAKE THE OPPORTUNITY
TO REALLY APPLAUD OUR STAFF THAT
HAVE WORKED REALLY HARD UNDER
VERY, VERY SHORT NOTICES TO COME
UP WITH GREAT IDEAS AND PUT THEM
TOGETHER INTO VERY, VERY
COHERENT AND IMPACTFUL FUNDING
OPPORTUNITY ANNOUNCEMENTS.
AND SO THE MESSAGE IS THERE THAT
THERE'S A LOT OF INTEREST IN
PAIN RESEARCH, IT'S WELL
JUSTIFIED.
THIS IS AN ENORMOUS PROBLEM FOR
OUR POPULATION.
AND THE NIH REALLY HAS TAKEN A
LOT OF STEPS TO ACTUALLY REALLY
ADDRESS SOME OF THESE ISSUES AND
PROVIDE OPPORTUNITIES FOR
INVESTIGATORS IN MULTIPLE
DOMAINS AND I DO HOPE THAT YOU
TAKE ADVANTAGE OF ALL THESE
PROGRAMS AND PLEASE MAKE SURE
THAT YOU CONTACT US AND DISCUSS
YOUR IDEAS AND SUBMIT YOUR
APPLICATIONS.
SO WITH THAT, IF YOU HAVE ANY
QUESTIONS, I'LL BE HAPPY TO
ANSWER THEM.
>> QUESTIONS FROM COUNCIL FOR
DR. EDWARDS?
>> I THINK EVERYBODY IS
SATURATED WITH HEARING THE WORD
"PAIN" AND ALSO THE WORD
"OPPORTUNITY."
>> DR. EDWARDS, THANK YOU SO
MUCH FOR SHARING THAT WITH US.
I JUST WANTED TO ASK, I KNOW
THERE'S EXISTING INITIATIVES AND
THEN THERE'S THIS POSSIBILITY OF
ADDITIONAL BUDGET, AND OF COURSE
THE NEED TO MOVE QUICKLY IF THAT
BUDGET DOES BECOME AVAILABLE.
AND I KNOW THAT THAT PUTS
TREMENDOUS PRESSURE ON STAFF AND
PEOPLE WRITING PROPOSALS IF THE
BUDGET DOES BECOME AVAILABLE.
I WONDER WHETHER THE STRATEGY IS
TO TAKE ADVANTAGE OF THE
EXISTING INITIATIVES AND EXPAND
THE AMOUNT OF COVERAGE, IF THAT
BUDGET DOES BECOME AVAILABLE, OR
IF IT'S TO TRY TO CREATE NEW
INITIATIVES AND IF THERE'S
ALREADY SOME PLANNING FOR WHAT
THOSE MIGHT BE, IF INDEED THE
BUDGET DID COME AVAILABLE?
>> I THINK THAT'S WHY WE
ACTUALLY ADOPTED THIS
MULTI-PRONGED APPROACH.
WE STARTED OUT WITH THE
SUPPLEMENT INITIATIVE.
THAT WOULD GIVE, YOU KNOW,
INVESTIGATORS AN OPPORTUNITY TO
KIND OF DIP THEIR TOES IN THE
WATER AND START GETTING
PRELIMINARY DATA AND THEN LATER
ON APPLY FOR THE EXISTING
NOTICE.
LATER ON THIS AFTERNOON WE'RE
GOING TO HAVE THE CONCEPT
CLEARANCE THAT'S GOING TO AGAIN
EXTEND THE TIMELINE BEYOND 2022.
I THINK THAT'S WHAT WE'RE
THINKING IS THAT WE DO REALIZE
THIS IS AN EXTREMELY AMBITIOUS
TIMELINE, BUT IN ORDER TO MEET
THE MANDATE AND ACTUALLY BE ABLE
TO ACCESS THE BUDGET, IF WE GET
IT, THAT WE HAVE VERY LITTLE
CHOICE TO DO THAT.
SO, YOU KNOW, IT'S REALLY A
STRESSOR OR NOT ONLY NIH STAFF
BUT ALSO ON INVESTIGATORS AS
WELL.
BUT IT IS WHAT IT IS.
>> SOUNDS LIKE THE BEST POSSIBLE
STRATEGY.
>> YES.
>> IF I COULD ADD, AT THE
BEGINNING WE WANTED TO RULE OUT
STARTING ENTIRELY NEW
INITIATIVES, DE NOVO, YOU KNOW,
THE RE-JOIN INITIATIVE YOU JUST
HEARD IS ONE OF THE FEW THAT
ACTUALLY GOT PUSHED THROUGH, THE
HEAL INITIATIVE, FOR FY 22, BUT
THE TIMELINE FOR SUBMITTING
APPLICATIONS IS VERY SHORT,
RIGHT?
SO WE DECIDED TO KIND OF TAKE A
LITTLE BIT, YOU KNOW, A MORE, AS
EMMELINE DESCRIBED, A BROADER
APPROACH THAT WOULD NOT CREATE
BRAND NEW INITIATIVES THAT WOULD
BE DIFFICULT FOR PEOPLE TO DO
FROM EVERY POSSIBLE ANGLE.
>> ANY OTHER QUESTIONS ABOUT
CURRENT FUNDING OPPORTUNITY
ANNOUNCEMENTS AVAILABLE THAT
PEOPLE HAVE?
THERE ARE A LOT I THINK IS THE
SHORT STORY.
TAKE HOME THAT MESSAGE.
IF YOU HAVE AN IDEA RELATED TO
PAIN RESEARCH WE'RE INTERESTED.
YOU CAN CERTAINLY FIND ONE
THAT'S AVAILABLE TO YOU.
THANK YOU VERY MUCH, DR.
EDWARDS.
WE'RE NOW GOING TO SHIFT TO THE
PRESENTATION BY DR. ROBIN
BOINEAU, REQUIRED TRIENNIAL
REPORT ON CLINICAL STUDIES.
DR. BOINEAU?
>> THANK YOU.
I'M GOING TO SHARE MY SCREEN.
IS THAT SHOWING UP FOR YOU ALL?
>> YES.
>> LET ME PUT IT IN THE -- ALL
RIGHT.
I'M ROBIN BOINEAU, DIRECTOR OF
OFFICE OF CLINICAL REGULATORY
AFFAIRS, I'M GIVING THE
TRIENNIAL REPORT, IT HAS TO BE
GIVEN EVERY THREE YEARS.
THE TOPIC IS INCLUSION OF --
FOCUS OF THE PRESENTATION IS
INCLUSION OF WOMEN AND
MINORITIES IN CLINICAL RESEARCH.
IT'S SOMETHING THAT'S GROWN OUT
OF THE WOMEN'S HEALTH MOVEMENT
AND THEN BECAME A POLICY IN 1986
REQUIRING INCLUSION OF WOMEN IN
CLINICAL RESEARCH AND PUBLISHED
IN 1987.
CONGRESS MADE THE POLICY AND OF
AND PUBLIC LAW THROUGH A SECONDS
OF NIH REVITALIZATION ACT OF
1993.
WHY IS MY -- NIH DIRECTOR IS
REQUIRED TO PROVIDE REPORT TO
CONGRESS, STATE OF RESEARCH,
THIS IS PART OF THE REPORT OF
HOW WE'RE DOING WITH INCLUSION
OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH.
KEEP IN MIND ENROLLING SUBJECTS
IN RESEARCH, YOU'RE NOT REQUIRED
TO ENROLL WHAT IS IN THE U.S.
CENSUS BUT TO CONDUCT RESEARCH
SO THAT THE FINDINGS WILL BE
GENERALIZABLE TO THE U.S.
POPULATION.
IF YOU'RE STUDYING A SPECIFIC
DISEASE PROCESS, YOU'RE GOING TO
WANT TO LOOK AT WHAT THE
INCIDENCE OF THAT DISEASE IS IN
THE U.S. POPULATION TO HELP YOU
DEFINE YOUR POPULATION.
SO WHERE DO WE GET THIS DATA
YOU'RE LOOKING AT TODAY?
IF YOU'RE AN INVESTIGATOR YOU
PROVIDE INCLUSION ENROLLMENT
REPORT.
THIS IS FROM FY 19, 20, 21.
THIS HAS THE OF DOMESTIC
ENROLLMENT.
INVESTIGATORS ARE STUDIES
ENROLLING IN CANADA OR OTHER
COUNTRIES, THAT DATA IS NOT
INCLUDED HERE.
IT'S FOR EXTRAMURAL AND
INTRAMURAL RESEARCH PROJECTS.
AND THE CLINICAL RESEARCH DATA
IS FROM THE 2018 DATA, REPORTED
IN THE 2019 ANNUAL REPORT.
THE 2020 DATA YOU'RE SEEING 2019
ENROLLMENT.
AND THEN ONE TO KEEP IN MIND
WHEN WE LOOK AT THE DATA
REPORTED AS 2021, DATA THAT CAME
IN IN 2020.
SO WE START IN OCTOBER, OF 2019,
AND WE GO THROUGH SEPTEMBER OF
2020.
SO ABOUT SIX MONTHS OF THAT DATA
WE WERE NOT AFFECTED VERY
GREATLY BY COVID.
BUT THE SECOND SIX MONTHS OF
2020, YOU KNOW, WE HAD MORE
IMPACT OF COVID-19 ON STUDY
RECRUITMENT.
OKAY.
SO HOW MANY STUDIES ARE WE
LOOKING AT FOR THIS REPORT
TODAY?
SO, THE ONE TO FOCUS ON IS THE
NUMBER OF STUDIES THAT HAD
ENROLLMENT.
SO IN 2019, THERE WERE 102.
IN 2020, 113.
AND 2021, 123.
AND THE PHASE 3 STUDIES THERE
WERE TWO, IN 2019.
TEN IN 2020.
AND AGAIN 10 IN 2021.
SO THIS IS ALL NCCIH INTRAMURAL
AND EXTRAMURAL DEFINED CLINICAL
RESEARCH IN 2019.
OKAY.
SO, THE THINGS TO NOTICE HERE
ARE IN OF WE HAD ALMOST 10,000
PATIENTS ENROLLED, ALL OUR
STUDIES, IN 2019 THAT WENT UP TO
15 OR 16,000, UP TO 50,000
ALMOST IN 2021.
WHAT WERE THE DISTRIBUTIONS OF
WOMEN AND MEN?
SO, SLIGHTLY OVER 50% IN 2019.
AND CLOSER TO 50/50 IN 2020,
SLIGHTLY LESS IN 2021.
SO THEN WE LOOK AT MINORITY
ENROLLMENT.
SO THIS IS ALSO BOTH INTRAMURAL
AND EXTRAMURAL DATA.
SO THE SAME NUMBERS FOR TOTAL
ENROLLMENT, AND MINORITY
ENROLLMENT WE'VE GOT 25% OF THE
TOTAL ENROLLMENT IN 2019, 26% IN
2020, AND 27% IN 2021.
AND THEN LOOKING AT HISPANIC AND
LATINO VERSUS NON-HISPANIC AND
SO NON-HISPANIC OBVIOUSLY
INCLUDES MINORITY GROUPS THAT
ARE NOT HISPANIC, RIGHT?
SO ETHNICITY VERSUS RACE.
AND SO WE HAD A VERY SMALL
PROPORTION OF HISPANIC SUBJECTS
ENROLLED IN 2019, 2020, 2021
COMPARED TO NON-HISPANIC
POPULATION.
AND SO NOW WE'RE GOING TO GO AND
LOOK AT TOTAL ENROLLMENT IN
PHASE 3 CLINICAL TRIALS BY SEX.
SO, THE NUMBERS OF ENROLLMENT
ARE DIFFERENT, SO IN 2019, AS
YOU MAY RECALL, WE HAD TWO
STUDIES THAT WERE PHASE 3
STUDIES THAT WERE RECRUITING, WE
HAD 268 PATIENTS ENROLLED IN
2019.
WE HAD TEN STUDIES ENROLLING IN
REPORTING FOR 2020 DATA.
1476 PATIENTS.
AND IN 2021, THAT WENT DOWN,
1169.
PROPORTIONS OF FEMALE TO MALE IS
NOT THE SAME WE SAW OVERALL
WHERE WE KIND OF HAD CLOSER TO
50/ 50 OVERALL.
WOMEN TO MEN TENDING TO 1/ 3 TO
2/3.
AND CLINICAL DATA, SAME
ENROLLMENT SIZE, SAME POPULATION
AS THE LAST SLIDE.
HERE YOU'LL SEE MINORITY, IN THE
SMALL SAMPLE, IN TWO STUDIES.
32% IN MINORITIES IN 2020, AND
45% IN 2021.
AND THEN HISPANIC/NON-HISPANIC,
SMALL NUMBERS THE FIRST YEAR,
AND SPLIT WAS 28/80, 40/74.
AND 67%.
AND THIS IS -- I WANTED TO SHOW
A LOOK AT WHAT'S GOING ON IN OUR
INTRAMURAL PORTFOLIO.
TOTAL ENROLLMENT WAS 344 IN
2009.
1,407 IN 2020.
AND 2021, 2102 SUBJECTS.
MINORITY 64% IN 2019.
32% IN 2020.
UP HIGHER RATE, 38% IN 2021.
AND SPLIT TO MALE TO FEMALE, WAS
56% WOMEN, 45%, AND 45%
RESPECTIVELY FOR 2019, 2020,
2021.
AND THEN AS I SAID AT THE TOP
WE'RE NOT TRYING TO COMPARE TO
CENSUS DATA, WHEN PEOPLE DECIDE
WHAT THEIR GOAL IS FOR
ENROLLING.
TARGETS ARE FOR ENROLLING
MINORITIES.
BUT I THINK IT'S HELPFUL TO SEE,
FROM THE 2020 CENSUS, SLIGHTLY
MORE THAN HALF THE POPULATION
WAS WOMEN.
AND OUR NUMBERS OVER TIME HAVE
KIND OF REFLECTED THAT.
WE DO HAVE SLIGHTLY HIGHER THAN
THAT, MINORITIES 24%.
NUMBERS ARE SIMILAR TO THAT AS
WELL.
EXCUSE ME.
BUT I DO WANT TO MAKE THE
EMPHASIS THAT, NUMBER ONE, THE
THING TO KEEP IN MIND IS
COVID-19 EFFECTS ON STUDY
RECRUITMENT IS SOMETHING WE MAY
HAVE SEEN IN 2021, AS WE SAW
THAT THE DROP IN CLINICAL TRIAL
ENROLLMENT NUMBERS, AND THAT
REFLECTED WHAT WE WERE SEEING AS
WE WORKED WITH INVESTIGATORS
THAT WERE OUT IN THE FIELD
HAVING TO STOP STUDIES, AND WORK
ON ISSUES RELATED TO COVID
BEFORE THEY WERE ABLE TO
REINITIATE CLINICAL STUDIES.
WE ARE -- WE SEE AT NCCIH AS
RECRUITMENT OF MINORITIES AS A
VERY IMPORTANT PART OF OUR GOALS
AND EFFORTS AT BOTH AT NIH AND
NCCIH, AS PART OF THAT.
THERE WAS AN NCCIH HOT TOPIC
WEBINAR ENGAGING DIVERSE
COMMUNITIES AND COMPLEMENTARY
INTEGRATIVE HEALTH, IF YOU
WEREN'T ABLE TO ATTEND THAT
THERE WAS A RECORDING OF THAT
TWO-HOUR PRESENTATION ONLINE.
THERE'S A LINK THERE.
IT WAS MENTIONED EARLIER TODAY
THE NIH UNITE PROGRAM THAT IS
LOOKING TO EXPAND.
A LOT OF THE EFFORTS TO ADDRESS
STRUCTURAL RACISM AT NIH, AND
ENCOURAGE YOU TO TAKE A LOOK AT
THAT TO SEE WHAT THE THINGS ARE
THAT ARE AVAILABLE TO THE NIH'S
SETTING UP TO ASSIST WITH THOSE
EFFORTS WHICH ARE OBVIOUSLY
IMPORTANT FOR US AS A COMMUNITY
IN THE UNITED STATES.
THE OTHER THING IS WE CONTINUE
TO SUPPORT INCREASED
PARTICIPATION OF WOMEN AND
MINORITIES IN NCCIH-FUNDED
STUDIES.
I WANT TO SAY THANK YOU FOR THE
HEAVY LIFTING, DENICE SIMMONS,
AND CHRISTINE WISHOFF, IN MY
GROUP, A VALUABLE JOB IN
ANALYZING AND PUTTING THIS
MATERIAL TOGETHER FOR THE
PRESENTATION TODAY.
THERE'S ALSO A WEBSITE THAT'S
PUBLICLY AVAILABLE WITH NIH DATA
THAT IS LOOKING AT DISEASE,
DISEASE OR CONDITION, HOW WE'RE
RECRUITING AT NIH.
THERE'S A WEBSITE, YOU CAN
SEARCH BY THE CONDITION, ASTHMA,
ET CETERA, AND SEE PROPORTION OF
WOMEN OR MEN.
ALSO CAN SORT BY ETHNICITY AND
RACE.
AND THE DATA IS AVAILABLE FOR
SUBJECTS ENROLLED IN FY 2018.
THAT'S MY PRESENTATION TODAY.
HAPPY TO ANSWER ANY QUESTIONS
YOU MAY HAVE.
>> THANK YOU.
>> CERTAINLY COVID HAS HAD
DRAMATIC EFFECT ON A LOT OF
PEOPLE IN TERMS OF RECRUITMENT
AND EVERYTHING ELSE WITH
INSTITUTIONS BEING SHUT DOWN.
GENERALLY, FUNDS ARE BEING
ALLOCATED TO RECOVER SOME GAPS
AND EXTEND RECRUITMENT.
HOW IS NCCIH GOING TO HANDLE
LOWER THAN ANTICIPATED
ENROLLMENT THAT'S PRETTY MUCH
DUE SPECIFICALLY TO COVID, IN
TERMS OF ONGOING EXPERIMENTS?
>> I DON'T KNOW IF EMMELINE
WANTS TO FOLLOW UP.
I'VE BEEN THE PROJECT SCIENTIST
ON A LOT OF LARGE STUDIES, AND
CONVERSATIONS WITH INVESTIGATORS
AT THE BEGINNING WAS THAT WE
ANTICIPATE THIS IS GOING TO
BE -- IT'S VERY BROAD, AND VERY
DEEP, THE NUMBER OF
INVESTIGATORS THAT ARE GOING TO
BE AFFECTED BY THIS.
WE DON'T ANTICIPATE WE COULD
POSSIBLY HAVE THE MONEY TO
RECRUIT FOR THAT.
SO IT'S IMPORTANT, YOU KNOW,
WHEN WE SAW THIS HAPPENING TO
SEE WHAT YOU CAN DO TO SAVE
FUNDS, RIGHT?
AND I THINK THE OTHER THING THAT
WE ALWAYS DO IN WORKING WITH
INVESTIGATORS IS SAY WHAT IS
YOUR MAIN QUESTION, WHAT CAN YOU
DO TO MAKE SURE YOU'RE ANSWERING
YOUR PRIMARY AIM?
AND WHAT DO YOU HAVE
FUNDING-WISE TO HELP WITH THAT?
WE DO HAVE FUNDS TO HELP FOLKS
THAT HAVE -- DON'T HAVE ENOUGH
FUNDS.
THERE ARE SOME FUNDS THAT COME
IN.
AS YOU CAN IMAGINE, IT COULDN'T
POSSIBLY COVER EVERY NEED.
AND SO WHAT WE'RE DOING IS AS
PEOPLE COME IN, AND I THINK THE
OTHER THING IS PEOPLE ARE GOING
TO START ASKING, AS THEY RUN OUT
OF MONEY, RIGHT?
IF THEY HAVE A STUDY THAT'S
THREE YEARS LONG FROM, YOU KNOW,
OR FIVE YEARS LONG, THEY ARE TWO
OR THREE YEARS INTO THE STUDY,
DEPENDS WHEN THEY ARE GOING TO
START NEEDING MORE.
REGULAR CONVERSATION.
WHAT CAN YOU DO WITH THE MONEY
YOU HAVE?
AND THEN WE CAN HELP YOU LOOK
AND SEE WHAT ARE THE OPTIONS.
YOU KNOW, ARE YOU ABLE TO
COMPLETE THE STUDY?
ONE OF THE THINGS WE SAW WAS A
LOT OF PEOPLE WERE ABLE TO
TRANSITION TO REMOTE
INTERVENTIONS, AND WERE ABLE TO
FIND COST SAVINGS THAT WAY.
I THINK IT'S BEEN A HEAVY LIFT
FOR THE INVESTIGATIVE COMMUNITY,
AND WE'RE HERE TO HELP.
AND SO IT'S GOOD TO KNOW AS WELL
AS FAR IN ADVANCE AS POSSIBLE
WHAT THE ISSUES ARE, AND HAPPY
TO HELP WALK THROUGH WHAT THAT
IS.
EMMELINE, DID YOU HAVE SOMETHING
TO ADD TO THAT?
>> YEAH, I'LL JUST ADD THIS HAS
BEEN REALLY AN ONGOING
CONVERSATION BETWEEN OUR PROGRAM
STAFF AND THE INVESTIGATORS,
AND, YOU KNOW, WE'VE REALLY HAD
MAXIMUM FLEXIBILITY BUT WANT TO
PRESERVE INTEGRITY OF THE
RESEARCH AND SO, YOU KNOW, A LOT
OF, YOU KNOW, BRAINSTORMING WITH
INVESTIGATORS, AS ROBIN
MENTIONED, GUIDING THEM AND
COMING UP WITH STRATEGIES TO
MAXIMIZE WHERE THEY ARE INTO
THEIR PROJECT AND THAT'S -- I
MEAN, YOU KNOW, SOME
INVESTIGATORS WERE VERY
ENTERPRISING AND WERE ABLE TO
PIVOT, BUT OTHERS, YOU KNOW,
REQUIRED MORE WORK, DIFFERENT
PROGRAM, INVESTIGATORS TO COME
UP WITH A GOOD STRATEGY TO
PRESERVE, YOU KNOW, THE RESEARCH
THAT THEY WERE DOING.
>> GREAT.
THANKS.
>> ANY OTHER QUESTIONS ABOUT THE
TRIENNIAL REPORT?
>> OKAY, THANK YOU ALL.
>> THANK YOU, EVERYONE.
WE'RE NOW GOING TO GO TO A
RECOGNITION CEREMONY FOR THOSE
MEMBERS WHOSE TERMS HAVE EITHER
ALREADY RECENTLY CONCLUDED OR AS
IN DR. TIMERMAN'S CASE ARE
CONCLUDING TODAY.
DR. LANGEVIN, WOULD YOU LIKE TO
LEAD US?
IN ADDITION TO DR. TIMERMAN,
DOCTORS ANDERSON, AND YEY ARE ON
THIS CALL NOW.
UNFORTUNATELY DR. McMILLAN HAD
AN INTERNET PROBLEM AND WAS
UNABLE TO JOIN US.
LOST HIS INTERNET CONNECTION,
THE WHOLE REGION, DUE TO A WIND
STORM.
>> OH WOW!
>> DR. LANGEVIN?
>> WELL, IT IS A BITTERSWEET
MOMENT SAY GOOD-BYE TO FOUR
WONDERFUL COUNCIL MEMBERS WITH
US NOW --
>> I'M OFF CAMERA.
>> AND NORMALLY IN PERSON, I
WOULD BE HANDING YOU A
CERTIFICATE AND I WOULD BE
THANKING YOU AND SHAKING HANDS.
IT'S HARD TO BELIEVE WE USED TO
DO THESE THINGS.
YOU KNOW, AND SO I WANTED TO AT
LEAST BEGIN, WHEN I SAY YOUR
NAME, TURN ON YOUR CAMERA AND WE
CAN WAVE AT YOU AND SAY THANK
YOU AND GOOD-BYE.
FIRST, GLORIA, WHERE ARE YOU?
ARE WE IN ORDER?
GLORIA YEH, SHE DROPPED OFF.
>> CAN YOU SEE ME?
>> YES.
>> HELLO!
>> IT'S BEEN SUCH A PLEASURE
HAVING YOU ON THE COUNCIL.
AND WE WANT TO THANK YOU.
WE WANT TO WISH YOU THE BEST.
IT'S TOO BAD ONLY PART OF YOUR
TENURE, AT LEAST SOME WAS IN
PERSON.
WE HAD THE MIXED EXPERIENCE.
>> THANK YOU.
>> THANK YOU, NCCIH, IT WAS
REALLY A PLEASURE AND HONOR.
I OWE SO MUCH TO NCCIH FOR MY
WHOLE CAREER.
IT WAS WONDERFUL TO BE ABLE TO
CONTRIBUTE BACK TO THE MISSION.
>> IT WAS GREAT TO HAVE YOU.
YOUR EXPERTISE CONTRIBUTED
GREATLY TO OUR COUNCIL.
SO THANK YOU.
AND NEXT, I DON'T KNOW WHO IS
NEXT.
YOU TELL ME.
OH, WHERE ARE YOU, BARBARA?
>> I'M HERE.
>> BARBARA TIMERMAN, THANK YOU
FOR BEING A COUNCIL MEMBER.
WE APPRECIATE ALL THE EXPERTISE
THAT YOU GAVE US, AND WE WISH
YOU THE BEST.
YOU KNOW, WE'LL MISS YOU.
>> I WILL MISS YOU TOO.
I'M ALREADY MISSING YOU.
THIS HAS BEEN MY SECOND COUNCIL.
I WAS PART OF THE ORIGINAL
OFFICE OF ALTERNATIVE MEDICINE
WITH JOSEPH JACOBS.
TODAY I LEARNED A LOT ABOUT
JOINTS AND WILL RESPECT MY
JOINTS MUCH MORE.
SO THANK YOU SO MUCH.
GOOD LUCK IN THE FUTURE.
I WILL MISS YOU.
>> WE WILL MISS YOU TOO.
THANK YOU VERY, VERY MUCH FOR
YOUR SERVICE ON OUR COUNCIL.
WE REALLY APPRECIATE IT.
>> I SEND KISSES TO ALL.
BYE-BYE.
>> VIRTUAL HUGS.
>> DR. McMILLAN IS UNABLE TO
JOIN US.
>> WE'LL SAY A VIRTUAL GOOD-BYE
TO DR. JOHN McMILLAN, WHO WAS
A WONDERFUL COUNCIL MEMBER AS
WELL.
WE'LL MISS HIM AS WELL.
FINALLY, BO ANDERSON.
WE'LL MISS YOU.
YOU'VE KEPT US ON OUR TOES
REGARDING SO MANY THINGS YOU
WOULD REMIND US OF, WE'RE
GRATEFUL FOR OUR CONTRIBUTIONS
TO OUR COUNCIL.
THANK YOU.
>> WELL, THANKS SO MUCH, HELENE.
IT'S BEEN AN HONOR AND
PRIVILEGE.
I LOVED ALL THE CONVERSATIONS WE
HAD AND GETTING TO KNOW NEW
COLLEAGUES AND RECONNECTING WITH
OLD COLLEAGUES.
I WAS VERY INTERESTED IN THE
CONVERSATION TODAY ABOUT TOUCH
AND I'M SO GLAD TO HEAR THAT
BEING EMPHASIZED, REALLY GETS TO
THE HEART OF WHAT HEALING IS ALL
ABOUT.
THANK YOU SO MUCH FOR SERVING AS
DIRECTOR.
YOU'RE TRANSFORMING THE WHOLE OF
THE NCCIH, I KNOW I SPEAK ON
EVERYONE'S BEHALF BY SAYING HOW
GRATEFUL WE ARE.
THANK YOU.
>> WE'RE ALL ON THIS JOURNEY
TOGETHER.
IT'S BEEN GREAT.
ALL THE COUNCIL MEMBERS, I FEEL
LIKE YOU'RE ALL SUCH A GREAT
GROUP.
IT'S INTERESTING TO SEE HOW THE
GROUP EVOLVES BUT STILL STAYS
ONE.
IT'S GREAT.
THANK YOU FOR YOUR
CONTRIBUTIONS, ALL OF YOU.
WE'LL MISS YOU.
>> THANK YOU, EVERYONE.
WE'RE NOW GOING TO GO CLOSE TO
THE LAST THING, CONCEPT
CLEARANCE, PRESENTED BY DR.
CRAIG HOPP, DEPUTY DIRECTOR OF
THE DIVISION OF EXTRAMURAL
RESEARCH.
CRAIG?
>> THERE WE GO.
I'LL TURN ON MY CAMERA.
>> PRESENTATION VIEW.
>> YES.
LET'S SEE IF I CAN FIGURE OUT
HOW TO DO THAT.
HOW ABOUT NOW?
>> YES.
>> WONDERFUL.
SO, GOOD AFTERNOON, EVERYONE.
I'M HAPPY TO PRESENT TO YOU
TODAY A CONCEPT FOR NCCIH
HIGH-PRIORITY PAIN RESEARCH,
THERE'S THAT WORD AGAIN.
YOU HEARD A LOT ALL DAY LONG
WITH THE ONGOING ACTIVITIES
ACROSS A VARIETY OF SPECTRUM OF
PAIN-RELATED ACTIVITIES.
THIS CONCEPT WOULD CONTINUE, AS
EMMELINE INDICATED, EXTEND THE
ARC OF ACTIVITIES.
I'LL REMIND FOLKS A CONCEPT IS
AN INTENTIONALLY BROAD BASKET OF
INTEREST AREAS THAT NCCIH HAS
THAT ALLOWS US FLEXIBILITY TO
HAVE POTENTIALLY MULTIPLE
FUNDING OPPORTUNITY
ANNOUNCEMENTS THAT WOULD BE
COVERED UNDER SUCH A CONCEPT.
HOWEVER, BY NIH POLICY, WE DO
NOT DISCUSS ANY OF THE DETAILS
OF ANY INITIATIVE OR FUNDING
OPPORTUNITY THAT MIGHT EMERGE
FROM THIS, THIS ONE, PRESERVES
FLEXIBILITY TO IMPLEMENT CONCEPT
AND, TWO, FOR YOUR BENEFIT, YOU
CAN ALL AS COUNCIL MEMBERS
SUBMIT APPLICATIONS TO THESE
THINGS.
SO, WE'VE TALKED ABOUT THIS ALL
DAY.
WE'RE IN THE MIDST, IN THE
THROES OF A PUBLIC HEALTH
EMERGENCY RELATED TO THE OPIOID
MISUSE AND ADDICTION CRISIS,
FIRST DECLARED IN OCTOBER OF
2017, RENEWED EVERY THREE
MONTHS, REMAINS ACTIVE.
WE STILL HAVE ONGOING PAIN
EMERGENCY.
SUBSEQUENT, CONGRESS
APPROPRIATED THE NIH WITH A HUGE
AMOUNT OF MONEY, HUNDREDS OF
MILLIONS OF DOLLARS, WHICH AS
YOU ALL KNOW NOW NIH PACKAGED
INTO THE HEAL INITIATIVE.
IT HAS TWO PRIMARY THRUSTS.
ONE IS IMPROVEMENTS IN OPIOID
MISMUX OF USE -- MISUSE AND
ADDICTION AND IMPROVEMENT IN THE
PAIN.
YOU WOULD THINK AFTER ALL THE
INVESTMENT WE'VE MADE A LARGE
AMOUNT OF PROGRESS IN THE OPIOID
CRISIS.
THAT'S NOT THE CASE.
CDC REPORTED RECENTLY IN 12
MONTHS ENDING APRIL OF 2021
THERE WERE OVER 100,000 DRUG
OVERDEATHS IN THE U.S. ALONE.
THERE'S RUMOR THAT WE MIGHT HAVE
A LOT MORE FUNDS TO ADDRESS
THIS.
SPECIFICALLY TARGETED FOR PAIN
RESEARCH, IN ADDITION TO AND
SEPARATE FROM THE HEAL
INITIATIVE, ALSO GOING TO BE
GETTING MORE MONEY.
SO WITH THAT IN MIND NCCIH IS
INTERESTED IN DEVELOPING
INITIATIVE THAT WOULD DIRECTLY
ADDRESS THIS OPIOID CRISIS
THROUGH THE IMPROVED MANAGEMENT
OF NON-PHARMACOLOGIC PANDEMIC
NON-ADDICTIVE PAIN APPROACHES.
AND THE GOALS OF THE CONCEPT ARE
MULTI-FOLD.
ONE, WE WANT TO ACCELERATE AND
CONTINUE TO INVEST IN PAIN
RESEARCH AND BY FOCUSING ON PAIN
THERE BY ADDRESSING THE
UNDERLYING CAUSE OF THE OPIOID
MISUSE CRISIS.
THIS WILL ALLOW US BY
IMPLEMENTATION TO EXTEND OUR
EFFORTS TO FY 23 AND BEYOND,
WHILE ALSO FILLING GAPS IN
CURRENT INITIATIVES THAT WE HAVE
CURRENTLY ONGOING.
AND THE TOPICS YOU'RE GOING TO
SEE OVER THE NEXT TWO SLIDES
SHOULD BE VERY FAMILIAR TO YOU
BECAUSE THEY HAVE BEEN MENTIONED
IN OTHER PLACES THROUGHOUT THE
DAY, THE POINT IS THAT WE'LL BE,
AGAIN, UTILIZING THESE THINGS TO
FILL IN GAPS IN EXISTING
PORTFOLIO AS WELL AS TRYING TO
ADDRESS OPIOID MISUSE CRISIS
THAT WE HAVE STILL ONGOING.
SO, AGAIN, THESE TOPICS ARE
THINGS YOU'VE SEEN FOCUSING ON
SICKLE CELL DISEASE, MYOFASCIAL
PAIN, FORCE BASED MANIPULATION,
NATURAL PRODUCTS BUT DO GO IN
DIFFERENT DIRECTIONS, PUBLISHED
INITIATIVES ARE CURRENTLY
INVOLVED N FOR EXAMPLE
MYOFASCIAL PAIN HEAL INITIATIVE
IS FOCUSED ON CLINICAL RESEARCH.
WITHIN THIS CONCEPT WE'RE
INTERESTED IN BASIC AND
MECHANISTIC RESEARCH.
SIMILARLY WE'RE INTERESTED IN
MUSIC THERAPIES FOR PAIN
MANAGEMENT, MULTI-COMPONENT,
AND mHEALTH TRIALS USING
COMPLEMENTARY AND INTEGRATIVE
INTERVENTIONS.
I WILL CONCLUDE THE CONCEPT
CLEARANCE PRESENTATION AND LOOK
FORWARD TO QUESTIONS OR COMMENTS
THAT COUNCIL MIGHT HAVE.
>> QUESTIONS FOR DR. HOPP
REGARDING THIS CONCEPT, FROM
COUNCIL?
>> SILENCE IS GOLDEN.
>> THAT'S FINE.
I'LL ASK FOR A MOTION FOR
APPROVAL OF THIS CONCEPT.
>> SO MOVED.
>> A SECOND?
>> SECOND.
>> ALL RIGHT.
IS THERE ANY DISCUSSION, FURTHER
DISCUSSION, ANY DISCUSSION MORE
THAN WHAT'S ALREADY BEEN DONE
FOR THIS CONCEPT?
HEARING NONE, WE'LL GO AHEAD FOR
A VOTE.
FOR THOSE COUNCIL MEMBERS WHO
ARE ELIGIBLE TO VOTE, YOU'LL
HAVE A POLL APPEARING ON YOUR
SCREEN.
AND IF YOU'RE ASKING A -- A VOTE
FOR YES IS APPROVING, NO IS
OPPOSITE, YOU'RE NOT APPROVING,
OR YOU MAY ABSTAIN.
I'M NOW SEEING 18 VOTES.
IT'S UNANIMOUS, CONCEPT HAS BEEN
APPROVED BY COUNCIL.
THANK YOU VERY MUCH.
THANK YOU, DR. HOPP.
>> THANK YOU!
>> SO THE LAST MATTER ON THE
AGENDA, I WANT TO REMIND THE
PUBLIC THAT IF THERE ARE --
AGAIN, BECAUSE THIS MEETING IS
VIRTUAL THERE IS NOT AN
OPPORTUNITY FOR MEMBERS OF THE
PUBLIC TO PROVIDE IN-PERSON
COMMENTS.
SO MEMBERS OF THE PUBLIC, IF
THEY WISH TO MAKE COMMENTS THAT
WOULD BE HEARD MY COUNCIL, YOU
SHOULD SEND THEM IN WRITING.
YOU CAN SEND THEM TO ME, MY NAME
SAND ADDRESS -- AND ADDRESS ARE
ON THE AGENDA AND FEDERAL
REGISTER.
YOU HAVE WITHIN 15 DAYS OF THIS
MEETING TO SUBMIT WRITTEN
COMMENTS, THEY SHOULD BE LESS
THAN 700 WORDS IN LENGTH, WHICH
WOULD BE THE EQUIVALENT OF A
FIVE-MINUTE VERBAL PRESENTATION.
AND THOSE COMMENTS WILL THEN BE
SHARED DIRECTLY WITH COUNCIL
MEMBERS VIA INTERNAL PROCESSES.
AND WITH THAT, I THINK WE'RE
COMING TO A CONCLUSION.
DR. LANGEVIN, YOUR FINAL REMARKS
FOR COUNCIL AND THE PUBLIC?
>> WELL, THANK YOU VERY MUCH.
THIS HAS BEEN A VERY INTERESTING
MEETING.
I REALLY WANT TO THANK YOU ALL
FOR YOUR INPUT AND THOUGHTFUL
DISCUSSION ALSO, QUESTIONS,
INTERESTS.
AS YOU CAN SEE, THIS HAS BEEN A
YEAR LIKE NO OTHER, AND I WANT
TO REALLY SAY A FEW WORDS ABOUT
THE FACT THAT WE RECOGNIZE, VERY
MUCH SO, HOW IN SOME WAYS
OVERWHELMING AND A LITTLE SCARY
IT IS, ALL THIS INFORMATION
WE'VE GIVEN YOU ABOUT ALL THESE
FUNDING OPPORTUNITIES.
WE REALIZE THIS IS A LOT.
WE REALIZE EVERYBODY IS GETTING
SORT OF TIRED AND I THINK THAT
THE IMPORTANT THING TO REMEMBER
IS THAT IF INDEED THERE IS
ADDITIONAL FUNDS FOR PAIN, THIS
WOULD BE AN OPPORTUNITY FOR
REALLY -- I DON'T WANT TO SAY
THE WORD JUMP START BECAUSE THE
HEAL INITIATIVE HAS ALREADY
DONE THAT, AS CRAIG MENTIONED.
THE HEAL INITIATIVE WAS TO
ADDRESS THE PAIN CRISIS.
BUT WHAT WAS REALLY MISSING WAS
OTHER, YOU KNOW, OPPORTUNITIES
THAT WERE DISTRIBUTED THROUGH
THE INSTITUTES, AND I THINK THIS
IS WHAT WAS RECOGNIZED IS THAT
THE FOCUS OF "HEAL" IS VERY
FOCUSED AND THERE ARE SOME OTHER
TYPES OF RESEARCH THAT CANNOT BE
FUNDED WITHIN THE HEAL
INITIATIVE, HAVING MORE
DISCRETIONARY FUNDING IS HELPFUL
ESPECIALLY IF INSTITUTES CAN
COMBINE TOGETHER LIKE WE'RE
TRYING TO DO WITH RE-JOIN,
WITHIN "HEAL" OR EVEN OUTSIDE OF
IT.
SO, IT'S GOOD NEWS AND BAD NEWS,
YOU KNOW.
GOOD NEWS THAT THERE MAY BE SOME
INCREASED ADDITIONAL FUNDS.
WE DON'T KNOW.
THE BAD NEWS IS THAT THE
TIMELINES ARE TIGHT.
I'M GOING TO SAY WE ALL DO WHAT
WE CAN.
IT'S NOT OUR FAULT DEADLINES ARE
CRAZY.
WE ARE SUFFERING FROM IT AS
WELL, YOU KNOW, IN TERMS OF
STRAIN ON OUR STAFF TO TRY TO
TURN THIS AROUND AS YOU CAN SEE
FROM EMMELINE DESCRIBING FUNDING
OPPORTUNITIES, ENORMOUS AMOUNT
OF WORK TO PUT THAT TOGETHER.
WE'RE ALL IN THIS TOGETHER.
LET'S JUST HOPE FOR THE BEST AND
IF THE FUNDS DON'T MATERIALIZE
THEN WE'LL HAVE LESS TO DO.
BUT ONE WAY OR ANOTHER WE'LL
KEEP, YOU KNOW, DOING EVERYTHING
THE BEST THAT WE CAN WITH THE
RESOURCES THAT WE HAVE.
SO, THANK YOU AGAIN, AND GOOD
LUCK GETTING OUT OF THIS
PANDEMIC.
I HOPE THE NEXT TIME WE MEET, IT
MAY NOT BE IN PERSON BUT I HOPE
IT WON'T BE IN COVID.
HAVE A GOOD EVENING, EVERYONE.
HAVE A GOOD WEEKEND.
>> THANK YOU, DR. LANGEVIN.
WITH THAT WE'LL CLOSE THIS
MEETING OF COUNCIL.
THANK YOU, COUNCIL, FOR YOUR
TIME AND EFFORTS.
IT'S BEEN A DELIGHT AND HONOR TO
BE WITH YOU TODAY.
>> BYE.
>> THANK YOU SO MUCH.