CFSAC December 2017 Day 1 Part 1

CFSAC December 2017 Day 1 Part 1


WELL, WELCOME. SORRY WE COULD NOT HAVE WARMER WEATHER HERE
IN WASHINGTON, BUT WELCOME TO THE SECOND MEETING OF THE CHRONIC FATIGUE SYNDROME ADVISORY COMMITTEE. THIS IS THE SECOND MEETING OF 2017. AS YOU ALL REMEMBER, WE HAD A MEETING IN JUNE
AND THE MEETING THAT TOOK PLACE IN JANUARY OF THIS YEAR WAS ACTUALLY THE MEETING FOR
LAST YEAR 2016. I WOULD LIKE TO WELCOME OUR CHAIR, DR. NEWTON, WHO THIS IS THE FIRST MEETING CHAIRING
THE MEETING WITH ME AND WE HAVE UPDATES FROM THE WORK GROUP THAT DR. NEWTON CHAIRS, AND THEN WE HAVE RECOMMENDATIONS
FROM THE MEDICAL EDUCATION WORK GROUP AND WE’LL HAVE OUR UPDATE FROM THE HHS AGENCY
AND THE SOCIAL SECURITY ADMINISTRATION. SOME LOGISTICS, THE BATHROOMS ARE PAST THE
DOUBLE DOORS TO THE LEFT AND THE CAFETERIA DURING LUNCH BREAK IS ALL THE WAY DOWN TO
THE RIGHT. I THINK MANY OF YOU HAVE BEEN IN THIS BUILDING
BEFORE. BUT IF YOU NEED ANY DIRECTIONS, JUST ASK US,
PLEASE. I WOULD LIKE TO REMIND YOU THAT WHEN YOU PLEASE
SPEAK, SPEAK CLEARLY AND LOUDLY AND SAY YOUR NAME FOR OUR NOTETAKER, DEBBIE HERE, SITTING
TO THE RIGHT. AND THOSE LISTENING ON THE PHONE AND VIA HHS
LIVE, YOU NEED TO HAVE A SPEAKER ON YOUR COMPUTER TO LISTEN TO THE MEETING. OTHERWISE, IF YOU DO NOT, YOU HAVE TO DIAL
THE 800 NUMBER, WHICH IS ON THE WEBSITE AND ON THE AGENDA, AND THEN CLICK ON THE LINK
FOR THE WEB LIVE STREAMING. WITHOUT FURTHER ADO, I WOULD LIKE TO WELCOME
DR. DONE WRITING, THE ACTING ASSISTANT DIRECTOR
FOR HEALTH, AND THE OFFICE OF HEALTH PROMOTION, HE WILL GIVE US, DON, IF YOU WOULD COME UP
TO THE FRONT, SOME OPENING REMARKS ON BEHALF OF THE DEPARTMENT AND THEN WE’LL MOVE INTO
SWEARING IN OUR NEW MEMBERS, WHO WE WILL OPEN THE FLOOR BRIEFLY SO THEY CAN TELL US A LITTLE
BIT ABOUT THEM.>>DR. WRIGHT?>>DON WRIGHT: THANK YOU FOR THAT INTRODUCTION. GOOD MORNING. DESPITE THE WEATHER, IT’S GOOD TO SEE ALL
OF YOU HERE TODAY, OBVIOUSLY YOU’RE PASSIONATE ABOUT THIS TOPIC AND WE APPRECIATE YOUR PARTICIPATION
IN THIS MEETING. ALSO THOSE OF YOU IN THE AUDIENCE, THANK YOU
FOR BEING HERE AS WELL AS THOSE YOU ATTENDING VIRTUALLY THIS VERY IMPORTANT MEETING. LET ME SAY YOUR INPUT AND RECOMMENDATIONS
IN WHAT YOU’LL BE DISCUSSING HERE TODAY IS VERY IMPORTANT TO THE DEPARTMENT OF HEALTH
AND HUMAN SERVICES AND MORE SPECIFIC TO THE OFFICE I LEAD, WHICH IS THE OFFICE OF THE
ASSISTANT SECRETARY FOR HEALTH. BEFORE I GET STARTED, I WANT TO TAKE JUST
A MOMENT AND THANK COMMANDER CEINOS, CERITA EVANS, DR. BETH COLLINS-SHARP AND THE CHAIR OF THE COMMITTEE,
DR. FAITH NEWTON, I UNDERSTAND THIS IS HER FIRST
MEETING TO CHAIR, I KNOW ALL THESE INDIVIDUALS HAVE WORKED TIRELESSLY TONE SURE THAT TODAY’S
MEETING OR THIS PARTICULAR MEETING IS A SUCCESS. I WOULD ALSO LIKE TO THANK BOTH THE PEDIATRIC
MYALGIC ENCEPHALOMYELITIS AND CHRONIC FATIGUE SYNDROME AND THE MEDICAL EDUCATION WORKING
GROUPS FOR PUTTING TOGETHER THE PRESENTATIONS YOU’RE GOING TO HEAR AND FOR THE RECOMMENDATIONS
THAT THEY MADE THAT WERE FORWARDED TO OUR ACTING SECRETARY HERE AT HHS, SECRETARY ERIC
HARGAN. LET ME SAY THAT I’M PLEASED THAT THE DEPARTMENT
HAS MADE SOME VERY TANGIBLE PROGRESS WITH THE SEPTEMBER ANNOUNCEMENT FROM THE NATIONAL
INSTITUTES OF HEALTH WHEN IT AWARDED FOUR GRANTS TO ESTABLISH A COORDINATED SCIENTIFIC
RESEARCH EFFORT ON ME/CFS, THE PROJECT WILL AWARD MORE THAN $7 MILLION PER YEAR FOR EACH
OF FIVE YEARS THAT THE PROJECT IS BEING IMPLEMENTED. THE FOUR NIH GRANTEES WILL COME TOGETHER TO
CREATE A CONSORTIUM OF THREE COLLABORATIVE RESEARCH CENTERS PLUS A DATA MANAGEMENT CONSULTING
CENTER, NIH EXPECTS THAT EACH ONE OF THESE COLLABORATIVE RESEARCH CENTERS WILL CONDUCT
INDEPENDENT RESEARCH BUT THAT THEY WILL NOT WORK IN SILOS. NIH EXPECTS THEM TO WORK TOGETHER ON SEVERAL
PROJECTS TO CREATE A NETWORK TO HELP ADVANCE RESEARCH ON THIS ISSUE. I UNDERSTAND THAT THIS COMMITTEE HAS RECOMMENDED
CENTERS OF EXCELLENCE AND RESEARCH NETWORKS ON A NUMBER OF OCCASIONS OVER THEIR EXISTENCE
AND I THINK THAT THIS IS A LAUDATORY, MAYBE MODEST STEP FROM SUPPORT RECOMMENDATIONS YOU’VE
MADE IN THE PAST. DR. VICKY WHITTEMORE WILL SPEAK MORE ABOUT THE
PROJECT I JUST DESCRIBED DURING HER PRESENTATION TOMORROW MORNING, I UNDERSTAND THIS IS A TWO-DAY
MEETING. IN CLOSING, I THANK YOU ONCE AGAIN FOR EXCHANGING
IDEAS AND ENGAGING IN HONEST AND OPEN DIALOGUE WITH YOU. THANK YOU FOR THE WORK THAT YOU DO WITH THE
DEPARTMENT AS WE MOVE SLOWLY BUT SURELY TO ADDRESS AND UNRAVEL THE MYSTERIES OF ME/CFS
AND TO REDUCE ITS IMPACT ON SO MANY INDIVIDUALS AND THEIR FAMILIES. WE HAVE A NUMBER OF ADVISORY COMMITTEES WITHIN
THE OFFICE OF THE ASSISTANT SECRETARY OF HEALTH, AND I’M JUST AMAZED AT THE WILLINGNESS OF
INDIVIDUALS SUCH AS THOSE OF YOU SITTING HAD HE TABLE TO SHARE YOUR TIME, YOUR EXPERIENCE,
YOUR EXPERTISE WITH THE DEPARTMENT TO ADDRESS A MAJOR ISSUE. SO AGAIN, THANK YOU FOR YOUR CONTRIBUTIONS. AT THIS TIME WE NEED TO SWEAR IN TWO NEW MEMBERS
TO THE COMMITTEE, WE HAVE DR. LUCINDA BATEMAN AND MS. AMRIT SHAHZAD, WHO WILL BE JOINING THE COMMITTEE. I ASK THESE TWO INDIVIDUALS TO STAND HERE
BY THE FLAG AND I WILL ADMINISTER THE OATH OF OFFICE. IF EACH OF YOU WILL RAISE YOUR RIGHT HAND
AND REPEAT AFTER ME. I, AND YOUR NAME, DO SOLEMNLY SWEAR, THAT
I WILL SUPPORT AND DEFEND THE CONSTITUTION OF THE UNITED STATES
AGAINST ALL ENEMIES, FOREIGN AND DOMESTIC, THAT I WILL BEAR TRUE FAITH AND ALLEGIANCE
TO THE SAME, THAT I TAKE THIS OBLIGATION FREELY, WITHOUT ANY MENTAL APPROXIMATE RESERVATION
OR PURPOSE OF EVASION, AND THAT I WILL WELL AND FAITHFULLY DISCHARGE THE DUTIES OF THE
OFFICE OF WHICH I’M ABOUT TO ENTER, SO HELP ME GOD. WELCOME TO THE COMMITTEE. [APPLAUSE]
>>CAN YOU HEAR ME? WELL, THIS IS STRANGE. IT’S SAYING FOR YOU NOT TO TALK, BUT ACTUALLY
IT HAS TO BE ON FOR PEOPLE TO HEAR YOU. I WANT TO TURN IT OVER TO OUR CHAIR, FAITH,
TO SAY A FEW WORDS.>>FAITH NEWTON: THANK YOU, WE ARE THRILLED
TO HAVE YOU HERE AT OUR IN-PERSON MEETING, AND AGAIN A SPECIAL WELCOME TO OUR MS. BATEMAN AND AMRIT, WE ARE GLAD TO HAVE YOU
HERE.>>GUSTAVO CEINOS: IF WE CAN TAKE FIVE MINUTES
FOR YOU TO TELL US ABOUT YOUR COMMITTEE, AND YOUR BACKGROUND, I HAD A LOT OF QUESTIONS
ABOUT YOU GUYS BUT I WOULD RATHER YOU SPEAK FOR YOURSELF.>>MY NAME IS LUCINDA BATEMAN, I’M A TRADITIONALLY
TRAINED GENERAL INTERNAL MEDICINE SPECIALIST AND HAVE BEEN A CLINICIAN IN THE FIELD SINCE
I STARTED PRACTICE IN 1991, AND IN 2000 I’VE HAD A CLINIC, A FULL-TIME CLINIC DEVOTED TO
EVALUATION OF TREATING CHRONIC FATIGUE AND CONDITIONS. WE ALSO HAVE CHANGED THE FOCUS AND I NOW WORK
AT A NONPROFIT CLINIC AND RESEARCH CENTER CALLED THE BATEMAN HORN CENTER IN SALT LAKE
CITY, UTAH, WITH HOPES OF MOVING PROGRESS FORWARD IN TERMS OF EDUCATION AS WELL AS RESEARCH
AND CLINICAL EXPERTISE.>>GUSTAVO CEINOS: THANK YOU.>>HI. MY NAME IS AMRIT SHAHZAD, I’M TRAINED AS A
PHYSICIAN, BUT I CAME TO U.S. IN 195 AND I’VE WORKED IN THE BIOTECH PHARMA INDUSTRY SINCE
THEN. NOW I’M AT UCSD. I AM A PATIENT OF CFS AND I DIDN’T BELIEVE
THE DISEASE WHEN I WAS A PHYSICIAN, SO YOU LIVE TO LEARN. THE FIRST ITEM THAT GAVE ME A CLUE THEY’D
THE DISEASE WAS THAT I HAD TRIED EVERYTHING AND I WAS STILL SICK. SO I’M HERE TO HELP IN ANY WHICH WAY I CAN.>>THANK YOU VERY MUCH. WE’RE GOING TO PROCEED WITH ROLL CALL NOW. IF YOU WOULD TURN ON YOUR MIC AND SAY HERE
WHEN I READ YOUR NAME. FAITH NEWTON, OBVIOUSLY, I’M HERE. ALISA KOCH?>>I’M HERE.>>JOSE MONTOYA IS NOT HERE YET. DONNA PEARSON?>>I’M HERE.>>CINDY BATEMAN?>>PRESENT.>>AMRIT SHAHZAD?>>I’M HERE.>>WE ARE GOING TO MOVE TO THE UPDATE ON RECOMMENDATIONS
FROM THE JANUARY AND JUNE CFSAC MEETINGS, THE SCREEN WILL GO DOWN SO EVERYBODY CAN SEE
WHAT THE RECOMMENDATIONS ARE. SO WHILE THAT’S HAPPENING, LET ME ENCOURAGE
THE NEW MEMBERS AND ALSO THE NEW REPRESENTATIVES ON THE COMMITTEE TO PLEASE ASK QUESTIONS AS
WE’RE GOING ALONG. ANY OF THE PRESENTATIONS, JUST MAKE SURE YOU
TURN YOUR MIC ON AND IDENTIFY WHO YOU ARE SO THAT THE NOTETAKER WHEN WE TRANSCRIBE THIS
KNOWS WHO IS SPEAKING. DONNA, DO YOU HAVE A QUESTION?>>CAN YOU HEAR ME OKAY?>>I WANT TO POINT OUT THAT OUR THREE NONVOTING
LIAISONS ARE ACTUALLY PART OF THE COMMITTEE, ALTHOUGH YOU’RE TRYING TO COUNT FOR QUORUM,
THEY ACTUALLY SHOULD BE PART OF THE ROLL CALL.>>FAITH NEWTON: LET’S DO THAT THEN.>>WE WEREN’T ACTUALLY LISTED UNDER ATTENDEES.>>WE’LL PUT YOU THERE.>>THANK YOU.>>NONVOTING MEMBERS. LEAH WILLIAMS?>>HERE.>>COURTNEY MILLER?>>HERE.>>THANK YOU.
AND TERRI IS IT WILDER OR WILDER?>>IT’S WILDER. I’M HERE.>>FAITH NEWTON: THANK YOU.>>FIRST SLIDE, PLEASE. OR NEXT SLIDE. THE FIRST RECOMMENDATION FROM THE JUNE MEETING
WAS THAT WE WOULD PROVIDE AN UPDATE ON THE ADULT AND PEDIATRIC ME/CFS RESEARCH, THAT
YOU SHOULD BE AN AGENDA ITEM AT ALL CFSAC MEETINGS. THE RESPONSE WAS THAT WE’LL WORK WITH THE
COMMITTEE CHAIR TO HAVE THAT RESEARCH PRESENTED TO THE COMMITTEE ON AN ANNUAL BASIS, THIS
REQUEST WILL BE ADDED TO THE STANDARD OPERATING PROCEDURE FOR CFSAC. TOMORROW DR. JOSE MONTOYA WILL PROVIDE AN UPDATE RESEARCH
FOR ADULTS WITH ME/CFS AND DR. ROSS VALIANCE WILL PROVIDE AN UPDATE ON RESEARCH
FOR YOUNG PEOPLE WITH ME/CFS. SECOND RESEARCH FROM JUNE, DEVELOP DIAGNOSTIC
TOOLS AND CLINICAL PRACTICE GUIDELINES, CFSAC RECOMMENDS THAT DISEASE-SPECIFIC DIAGNOSTIC
TOOLS BE DEVELOPED AND VALIDATED IN COLLABORATION WITH DISEASE EXPERTS AND ALSO THAT COMPREHENSIVE
CLINICAL PRACTICE GUIDELINES BE DEVELOPED IN ACCORDANCE WITH THE IOM STANDARDS FOR DEVELOPING
TRUSTWORTHY CLINICAL PRACTICE GUIDELINES. THE CDC RESPONSE IS THAT THEY RECOGNIZE THE
IMPORTANCE OF DEVELOPING CLINICAL PRACTICE GUIDELINES FOR USE BY PRIMARY CARE PHYSICIANS. THESE GUIDELINES NEED TO FULFILL EVIDENCE-BASED
STANDARDS SUCH AS GRADE AND IOM STANDARDS FOR DEVELOPING TRUSTWORTHY CLINICAL PRACTICE
GUIDELINES AND NEED TO BE DEVELOPED IN A COLLABORATIVE AND TRANSPARENT MANNER. CDC WILL DEVELOP A PLAN FOR DEVELOPING THESE
GUIDELINES TO BE REVIEWED AND SUPPORTED BY TRANS-HHS EX-OFFICIO WORKING GROUP AS SOON
AS FEASIBLE. UPDATES ON THIS PROCESS WILL BE PROVIDED TO
CFSAC AT EACH MEETING. ERMIAS BELAY WILL PROVIDE AN UPDATE REGARDING
THE CDC’S PRESENTATION ON DAY 2. JANUARY 2017 RECOMMENDATION. IT’S RECOMMENDED THAT AN ACKNOWLEDGMENT OF
THE SERIOUS EDUCATIONAL IMPLICATIONS OF ME/CFS IN CHILDREN AND ADOLESCENTS, AN EX-OFFICIO
MEMBER FROM THE U.S. DEPARTMENT EDUCATION BE ADDED TO CFSAC. WE FURTHER RECOMMEND THAT THIS INDIVIDUAL
BE WELL-VERSED IN THE PROVISION OF ACCOMMODATIONS AND SERVICES UNDER SECTION 504 OF THE CIVIL
RIGHTS ACT AND THE SPECIAL EDUCATION SERVICES UNDER THE INDIVIDUALS WITH DISABILITIES IN
EDUCATION ACT, IDEA. OHSH RESPONSE, THE OFFICE ON WOMEN’S HEALTH
WILL BE WORKING WITH THE OSHA COMMITTEE MANAGEMENT OFFICER TO REVISE THE CURRENT CFSAC CHARTER
TO INCLUDE AN EX-OFFICIO FROM THE DEPARTMENT OF EDUCATION. THE UPDATE IS THAT THE COMMITTEE MANAGEMENT
OFFICER ADVISE THE EX-OFFICIO FROM THE DEPARTMENT OF EDUCATION SHOULD BE OFFICIAL ADDED WHEN
THE CHARTER IS RENEWED. IN MARCH THE DFO REACHED OUT TO CARMEN SANCHEZ
AND INVITED HER TO REPRESENT THE DEPARTMENT OF EDUCATION ON CFSAC UNTIL AN OFFICIAL APPOINTMENT
IS MADE. SHE COULD NOT BE HERE THIS MORNING BUT SHE’LL
BE HERE AND PRESENTING TOMORROW. CDC RESPONSE. THE ME/CFS PROGRAM FULLY AGREES WITH THE RECOMMENDATIONS,
MY APOLOGIES, I SKIPPED AHEAD HERE, AND IS WORKING TOWARDS IMPLEMENTATION, CDC HAS IMPLEMENTED
THE CORRESPONDENCE WITH CARMEN SANCHEZ, THE DEPARTMENT OF ED AND WITH BETH NADI, NATIONAL
ASSOCIATION OF SCHOOL NURSES TO INCLUDE NEXT STEPS, PROCESS WILL BE INCLUDED IN THE REPORT
TO CFSAC. CDC AND THE NATIONAL ASSOCIATION OF SCHOOL
NURSES COLLABORATE TO DEVELOP AND DISSEMINATE EDUCATIONAL MATERIALS ON ME/CFS AS IT AFFECTS
CHILDREN AND ADOLESCENTS. A SLIDE WAS OUT OF ORDER. SO THAT WAS ONE OF THE RECOMMENDATIONS FROM
JANUARY THAT WE DEVELOPED AND DISSEMINATE EDUCATIONAL MATERIALS IN ME/CFS FOR NURSES
AND ADOLESCENTS, I’M GOING TO GO BACK, OKAY, THE CDC AGREED AND WE ARE WORKING TOWARDS
THAT WITH BETH NADI AND WITH CARMEN. YOU’LL GET AN UPDATE ON THAT DURING MY WORKING
GROUP PRESENTATION TOMORROW, OKAY? GUSTAVO?>>GUSTAVO CEINOS: SO I WANTED TO PRESENT
THIS TABLE TO THE COMMITTEE BECAUSE WE HAD HAD A LOT OF QUESTIONS ABOUT THE VACANCIES
AND THE NUMBER OF INDIVIDUALS AND WHEN THEIR TERMS EXPIRE. AS YOU KNOW, THE CHARTER CALLS FOR 13 MEMBERS,
WE SO FAR HAVE FAITH, ALISA, DONNA, JOSE MONTOYA, LUCINDA, THE NEW MEMBER WHO COULDN’T BE HERE
TODAY IS GUDUM LANGE, SHE’S IN EUROPE AND COULDN’T ATTEND BUT SHE’LL BE AT HOPEFULLY
AT OUR NEXT MEETING IN THE SUMMER, AND THEN UMRY, SO WE HAVE SIX VACANCIES. THE COLUMN TO THE RIGHT REPRESENTS THE THREE
FIELDS OR AREAS THAT THE COMMITTEE IS SUPPOSED TO BE MADE UP OF. WE HAVE ONE VACANT POSITION FOR A PATIENT
OR CAREGIVER, THEN WE HAVE ONE VACANT POSITION FOR A CLINICIAN, AND YOU WILL SEE WE HAVE
THE MOST VACANCY FOR THEN UNDER RESEARCHER. NEXT YEAR, EARLY NEXT YEAR, COME JANUARY,
I WILL DRAFT A FEDERAL REGISTER NOTICE CALLING FOR APPLICATIONS TO HAVE THIS COMMITTEE HOPEFULLY
FULFILLED BY THE SUMMER. SOME THINGS ARE BEYOND THE CONTROL OF THE
OFFICE OF WOMEN’S HEALTH, SO WE ONLY CAN INQUIRE ABOUT OUR NOMINATIONS. WHEN YOU SEE THE FEDERAL REGISTER NOTICE COMES
OUT, WHAT I WOULD LIKE YOU TO KNOW AND THE COMMITTEE IS THAT WHEN YOU APPLY, FOR EXAMPLE,
WE HAVE A FEDERAL REGISTER NOTICE ASKING FOR A CLINICIAN, YOU CANNOT APPLY IF YOU DON’T
HAVE ANY CLINICAL BACKGROUND, WE ARE LOOKING FOR SPECIFIC FIELDS, PEOPLE IN SPECIFIC FIELDS,
AND THAT HAS BEEN THE ISSUE IN THE PAST IN WHICH WE PUT OUT, AT LEAST AS LONG AS I’VE
BEEN AT DFO, WE PUT OUT A FEDERAL REGISTER NOTICE ASKING FOR SOMEBODY WITH A SPECIFIC
BACKGROUND AND WE GET INDIVIDUALS THAT DON’T NECESSARILY MEET THE NEEDS. THE PROCESS I WANTED TO MAKE SURE AND CLEAR
TO EVERYONE IS THAT THE EX-OFFICIOS REVIEW THESE APPLICATIONS AND THEY RANK THEM AND
THEN WE NOMINATE THEM AND PUT THEM FORWARD TO THE SECRETARY. WE DO NOT PICK INDIVIDUALS, THE SECRETARY
DOES, WE JUST PUT THEIR NAME FORWARD. MY UNDERSTANDING, AND THIS HAS NEVER BEEN
SHARED IN THE PAST WITH THE COMMITTEE, BUT I WANT TO BE OPEN AND CLEAR THAT THESE ARE
THE VACANCIES WE HAVE AND WHEN THE FEDERAL REGISTER NOTICE COMES OUT, WE WILL TRY TO
MEET THOSE VACANT POSITIONS AS LONG AS THE INDIVIDUAL MEETS THE REQUIREMENTS THAT WE’RE
LOOKING FOR. ANY QUESTIONS? DONNA?>>OF COURSE I DO. JUST TO BE CLEAR, THE PATIENT CAREGIVER ACTUALLY
IS A LITTLE BIT MORE EXPANDED THAN JUST PATIENT OR CAREGIVER. I THINK IF I RECALL THE CHARTER STATES YOU
NEED TO HAVE SOME EXPERIENCE RELATED TO ASSISTING PATIENTS OR VOLUNTEERING OR SOMETHING LIKE
THAT, SO YOU DON’T HAVE TO BE A DIRECT CAREGIVER OF A PERSON WITH A DISEASE.>>THAT’S CORRECT. COURTNEY?>>ARE THERE NOMINATIONS THAT WERE ALREADY
SUBMITTED FOR SOME OF THESE POSITIONS?>>GUSTAVO CEINOS: SO THE LAST FEDERAL REGISTER
NOTICE WE PUT OUT WAS IN — WE’RE IN DECEMBER — WAS IN THE SUMMER AND WE RECEIVED NOMINATIONS
FOR RESEARCHER AND WE RECEIVED NOMINATIONS FROM INDIVIDUALS THAT DIDN’T HAVE THE BACKGROUND
OR THE KNOWLEDGE THE AREA WE WERE LOOKING FOR SO ONLY AMRIT AND DR. BATEMAN WERE SENT FORWARD AND THEY WERE SENT
FORWARD TO THE SECRETARY AFTER THEY WERE RANKED BY THE EX-OFFICIOS.>>SO YOU HAVEN’T POSTED THE PATIENT CAREGIVER,
THE CLINICIAN ONE –>>NO, LIKE I SAY, THIS IS GOING TO HAPPEN
IN JANUARY AFTER THIS MEETING.>>IF I COULD JUMP IN WITH JUST A BIT OF EXPLANATION,
SINCE THE LAST APPOINTMENT OF MEMBERS, THERE WERE TWO, I BELIEVE, OR MAYBE EVEN THREE CALLS
FOR NEW MEMBERS, AND HE THIS ALL WENT THROUGH THE PROCESS, AND I BELIEVE THAT AMONG — THE
SITUATION OCCURRED WHERE ONE OF THE CALLS WAS FOR A RESEARCHER AND SOME OF THE APPLICANTS
WERE NOT RESEARCHERS, BUT THERE WERE OTHER INDIVIDUALS WHO SUBMITTED THEIR NAMES OR WHO
WERE NOMINATED AND ARE NOT SEATED TODAY OR NOT APPOINTED TODAY. I THINK THAT’S WHAT YOU WERE WONDERING, IF
THERE WERE PEOPLE WHO WERE NOMINATED THAT WERE NOT ACCEPTED, THEIR NOMINATION WAS NOT
ACCEPTED, AT SOME POINT DURING THE PROCESS.>>YEAH, I THINK THE PATIENT ONE HAS BEEN
VACANT FOR QUITE A WHILE, SO I’M JUST CURIOUS WHY — I KNOW THERE’S APPLICATIONS IN, NOMINATIONS
IN FOR IT, SO I JUST WANT TO MOVE THAT ONE, ALL OF THEM, BUT THAT ONE I KNOW IS KIND OF
SITTING OUT THERE, SO WE’RE GOING TO RETAKE NOMINATIONS FOR THAT POSITION?>>GUSTAVO CEINOS: ALL THOSE VACANT POSITIONS,
ONCE WE PRINT THE FEDERAL REGISTER NOTICE, WE WILL RECEIVE APPLICATIONS AND THEN THE
EX-OFFICIO WILL RANK THEM AND THEIR NAME WILL BE SENT FORWARD TO THE SECRETARY. ALISA?>>YEAH, ALISA KOCH HERE, I JUST WONDERED
SINCE — YOU KNOW, THANK YOU FOR SHARING THIS, BUT IT LOOKS LIKE THERE WERE TWO BIG PUSHES
TO GET MEMBERS, YOU KNOW, IN 2014 AND THEN AGAIN IN 2017, AND THANK YOU FOR DOING THAT. BESIDES ISSUING THIS NOTICE OR CALL, DO YOU
ALSO APPROACH INDIVIDUALS DIRECTLY AND ASK THEM WHETHER THEY WOULD LIKE TO BE INVOLVED
IN THIS?>>GUSTAVO CEINOS: I MEAN, WE COULD.>>I WOULD THINK MAYBE GIVEN THE NUMBER, THAT
MIGHT BE A GOOD THING TO TRY.>>GUSTAVO CEINOS: I REMEMBER AT THE JANUARY
MEETING APPROACHING ONE INDIVIDUAL WHO GAVE A VERY PASSIONATE PUBLIC COMMENT AND ASKING
THEN, WE WERE GOING ON PRINT A FEDERAL REGISTER NOTICE, IF HE WAS INTERESTED, TO LOOK OUT
FOR IT ON THE LISTSERV. SO I’VE DONE IT ONCE TO THAT SPECIFIC PERSON,
BUT THE PROCESS HAS TO BE OPEN AND FREE.>>SURE.>>GUSTAVO CEINOS: AND I’M CALLING OUT TO
THE COMMUNITY, TO YOU GUYS, IF YOU KNOW ALSO INDIVIDUALS, ONCE THE FEDERAL REGISTER NOTICE
COMES OUT, ENCOURAGE THEM TO APPLY. BUT APPLYING DOES NOT GUARANTEE THEN THE PERSON
WILL BE SELECTED, WE DON’T SELECT THEM, THE SECRETARY DOES.>>OF COURSE.>>DONNA?>>SO I JUST WANT TO CLARIFY AGAIN, UNDER
THE CLINICIAN HEADING, THE CHARTER SAYS THAT THREE SHALL BE INDIVIDUALS WITH EXPERTISE
IN HEALTHCARE DELIVERY, PRIVATE HEALTHCARE SERVICES OR INSURERS OR VOLUNTARY ORGANIZATIONS
CONCERNED WITH THE PROBLEMS OF INDIVIDUALS WITH ME/CFS. SO I JUST WANT TO MAKE SURE THAT THAT THAT’S
CLEAR, THEY DO NOT HAVE TO BE ACTUAL CLINICIANS, THEY JUST HAVE TO FIT WITHIN THAT CATEGORY.>>THANK YOU, DONNA.>>GUSTAVO CEINOS: IN THE VACANT POSITION,
YOU HAVE, YOU REMEMBER, SUSAN LIVING WHOSE TERM EXPIRED IN NOVEMBER. ANY OTHER QUESTIONS? WE SKIPPED A PART OF THE AGENDA, I APOLOGIZE,
WE NEED TO APPROVE THE MINUTES FROM THE LAST MEETING. AS YOU KNOW, THE MINUTES ARE POSTED ON THE
WEBSITE WITHIN 90 DAYS AFTER THE MEETING. THOSE MINUTES ARE APPROVED BY MYSELF AND THE
CHAIR, BUT WE WANT TO HAVE THE WHOLE COMMITTEE APPROVE THEM, AND IF THERE’S ANY CHANGE IN
THEM, WE WILL REVISE THE MINUTES FROM THE LAST MEETING AND POST THEM ON THE WEBSITE. BUT I SENT YOU THE LINK WITH THE MINUTES,
I HOPE YOU GUYS READ THEM AND WE CAN DISCUSS ANY CHANGES NOW.>>FAITH NEWTON: ANY CHANGES OR ADDITIONS
TO THE MINIMUM FRITZ FROM THE LAST MEETING? TO THE MINUTES FROM THE LAST MEETING? DO I NEED TO TAKE A ROLL CALL GUSTAVO, OR
CAN WE JUST DO IT AS ONE?>>GUSTAVO CEINOS: LET’S DO A ROLL CALL OF
ALL THE MEMBERS.>>FAITH NEWTON: ROLL CALL OF ALL THE MEMBERS? DONNA, NO COMMENTS ON THE MINUTES?>>I JUST TO WANT STAY I MAKE A MOTION THAT
WE ADOPT MINUTES AS PROVIDED.>>FAITH NEWTON: IS THERE A SECOND? HAD ANY OF THE MEMBERS CAN SAY SECOND.>>SECOND.>>FAITH NEWTON: ANY DISCUSSION? OKAY. I’LL DO AN INDIVIDUAL ROLL CALL. ALISA?>>APPROVE.>>FAITH NEWTON: DONNA PEARSON?>>APPROVE.>>FAITH NEWTON: CINDY BATEMAN?>>I’LL PASS. APPROXIMATE.>>FAITH NEWTON: AMRIT SHAHZAD?>>APPROVE.>>THE NONVOTING LIAISON?>>CAN’T VOTE.>>FAITH NEWTON: CAN’T VOTE. ALL RIGHT. ALL IN FAVOR? OBVIOUSLY THEY’RE APPROVED. I ALSO APPROVE. SO MINUTES HAVE BEEN APPROVED.>>GUSTAVO CEINOS: AND THEY’RE FINAL BECAUSE
THEY’RE ALREADY ON THE WEBSITE.>>FAITH NEWTON: THANK YOU.>>GUSTAVO CEINOS: NOW WE’LL MOVE TO PRESENTATIONS. DR. BELAY, YOU’RE UP.>>THANK YOU.>>SORRY, I CAN’T SEE MY SLIDES FROM THE PODIUM. I CAN DO IT FROM HERE.>>ERMIAS BELAY: I’M ERMIAS BELAY, CDC EX-OFFICIO
ON THE CFSAC, AND AS YOU’RE PROBABLY AWARE, THERE ARE A LOT OF ME/CFS ACTIVITIES HAPPENING
AT CDC OVER THE YEARS. THE MAJOR ONE THAT HAPPENED RECENTLY, THE
MCAM STUDY, AS MOST OF YOU KNOW, BUT MY UPDATE TODAY WILL FOCUS ON THE ACTIVITIES AND ACCOMPLISHMENTS
THAT HAPPENED SINCE THE LAST CFSAC MEETING, JUST TO SAVE TIME. I WILL START DESCRIBING ABOUT THE CDC WEBSITE,
YOU’RE PROBABLY AWARE THAT THE WEBSITE, WE ARE WORKING ON THE WEBSITE IN THREE DIFFERENT
SECTIONS. THERE WAS A SECTION FOR THE GENERAL PUBLIC
AND THERE’S A PEDIATRIC SECTION, WITH DIFFERENT FACT SHEETS, AND A SECTION FOR HEALTHCARE
PROFESSIONALS. THE SECTION FOR THE GENERAL PUBLIC WAS REVISED
AND POSTED ON OUR WEBSITE IN JUNE OF THIS YEAR, AND MOST OF YOU MAY HAVE ALREADY SEEN
THAT. THE SECTION FOR PEDIATRICS WHICH INCORPORATES
FACT SHEETS FOR EDUCATORS, EDUCATION PROFESSIONALS AND A FACT SHEET FOR HEALTHCARE PROFESSIONALS
AND PARENTS AND GUARDIANS, THESE ARE DOWNLOADABLE FACT SHEETS, WAS POSTED ON OUR WEBSITE IN
OCTOBER. THE SECTION FOR HEALTHCARE PROFESSIONALS,
WE’RE STILL WORKING ON THAT. WE HOPE TO COMPLETE THE DRAFT BY PROBABLY
AROUND EARLY JANUARY FOR AT LEAST HAVING IT CLEARED THROUGH CDC. CDC HAS ITS OWN CLEARANCE SYSTEM FOR ANYTHING
THAT WOULD BE POSTED ON THE WEBSITE. SO WITHIN THE ME/CFS PROGRAM, THE DRAFTING
WOULD BE FINALIZED AROUND JANUARY AND PREPARED THE CONTENT FOR CDC CLEARANCE, AND IT WILL
BE POSTED AS SOON AS THAT CLEARANCE IS OBTAINED WITHIN THE AGENCY.>>LEAH WILLIAM. DO YOU HAVE ANY KIND OF COMMUNITY REVIEW BEFORE
YOU POST THEM?>>ERMIAS BELAY: IF YOU RECALL, WE HAVE A
ROUNDTABLE THAT WE ORGANIZED OVER A YEAR AGO WHERE WE GATHERED INPUT FROM PATIENT COMMUNITIES
AND ME/CFS EXPERTS, SO OUR DRAFTING. WEBSITE INCORPORATES THOSE COMMENTS THAT WE’VE
RECEIVED. NOW, FOR THE HEALTHCARE PROFESSIONALS, WE
TRY TO SEEK OUT INPUT FROM CLINICIANS AND RESEARCHERS BEFORE FINALIZING AND PUTTING
IT ON THE WEBSITE.>>I JUST WONDERED IF YOU HAD ANY INPUT FROM
THE PEOPLE WHO WERE ACTUALLY AFFECTED BY THESE MATERIALS BEING AVAILABLE FOR HEALTHCARE PROFESSIONALS,
NAMELY THE PATIENTS.>>ERMIAS BELAY: IT WOULD BE THE DRAFTING
IS BASED ON THE INPUT WE’VE ALREADY RECEIVED. WE HAVE ALREADY RECEIVED COMMENTS AND GATHERED
UPDATES OR REVIEWS THAT WERE GIVEN AT THE ROUNDTABLE DISCUSSION THAT WE HAD ABOUT A
YEAR AGO.>>I UNDERSTAND THAT. BUT THAT DOESN’T NECESSARILY MEAN THAT EVERYTHING
THAT GETS INTO THE FINAL MATERIALS IS CONSISTENT WITH COMMENTS THAT WERE MADE AT THE BEGINNING
OF THE PROCESS.>>ERMIAS BELAY: WHAT WILL APPEAR IN THE FINAL
MATERIAL WILL BE A CDC-CLEARED VERSION. ONCE IT’S CLEARED BY CDC, WE CANNOT CHANGE
IT, BECAUSE AGAIN, WE WOULD HAVE TO DO ANOTHER CLEARANCE PROCESS, THAT WOULD SHORTEN THE
PROCESS. IS THERE ANYTHING YOU WANTED TO ADD, BETH?>>WE’RE DEFINITELY AWARE OF THE AREAS OF
CONCERN. I THINK THAT’S PERFECTLY CLEAR. AND THE MATERIALS THAT WERE PREPARED FOR THE
GENERAL PUBLIC REFLECT THE BASIC UNDERSTANDING. AND THE MAIN DIFFERENCE FOR THE HEALTHCARE
SECTION IS THAT IT WILL INCLUDE A LITTLE BIT MORE DETAILS, BUT IT’S BASICALLY THE SAME
MATERIAL, EXPANDED SOMEWHAT, PLUS WE INCLUDE BACKGROUND INFORMATION ON THE VARIOUS CASE
DEFINITIONS TO HELP CLARIFY FOR THEM. SO OUR PROCESS HAS BEEN FULFILLING WHAT WE
HAVE TO DO AT CDC AND WE ARE GATHERING, YOU KNOW, WE TALK TO PEOPLE IN A VERY INFORMAL
WAY AND GET INDIVIDUAL OPINIONS FOR THIS. SO I LOOK FORWARD TO A SUCCESSFUL COMPLETION
OF THIS WORK.>>THIS IS FAITH NEWTON. I WANT TO COMMENT ON THE FACT SHEET FOR EDUCATIONAL
PROFESSIONALS AND THE FACT SHEET FOR PARENTS AND GUARDIANS. I HAVE REVIEWED THEM AND I THINK THEY’RE EXCEPTIONALLY
WELL DONE. SO FOR OUR PARENTS OUT THERE THAT ARE LOOKING
FOR INFORMATION FOR CHILDREN, THE RESOURCES UP THERE ON THE CDC WEBSITE ON THE PEDIATRIC
PAGES ARE VERY, VERY WELL DONE, IF YOU’RE LOOKING FOR RESOURCES ABOUT SCHOOLS AND HOW
TO EDUCATE YOUR CHILDREN THAT HAVE ME/CFS, IT IS EXCEPTIONALLY WELL DONE.>>ERMIAS BELAY: THANK YOU, DR. NEWTON.>>FAITH NEWTON: YOU’RE WELCOME. CAN YOU IDENTIFY YOURSELF, PLEASE?>>YES, TERRI WILDER. SO I JUST HAD A QUESTION ABOUT THE WEB PAGE. SO WHILE THE CDC REMOVED EXERCISE AS A TREATMENT
ON YOUR WEBSITE, WE KNOW THAT EXERCISE OR EXERTION CAN BE HARMFUL TO SOME PATIENTS. SO IT FEELS LIKE THAT STATEMENT NEEDS TO BE
PUT IN IT, PARTICULARLY IN THE PROBABLY HEALTH PROVIDER SECTION, BUT DEFINITELY IN THE OTHER
SECTION THAT THE GENERAL PUBLIC WOULD BE LOOKING AT. I MEAN, I’M THINKING ABOUT KIND OF THE WORK
THAT’S BEEN DONE IN NEW YORK STATE WITH THE HEALTH COMMISSIONER SENDING OUT HIS LETTER
TO OVER 85,000 PHYSICIANS THAT SPECIFICALLY SAID, YOU KNOW, THIS CAN BE HARMFUL. SO PLEASE BE AWARE OF THAT WHEN YOU HAVE A
PATIENT THAT PRESENTS THAT YOU MAY BE DIAGNOSING WITH THIS DISEASE. I THINK WE NEED TO BE TEACHING PEOPLE ABOUT
KIND OF ENERGY ENVELOPES AND WHAT CAN HAPPEN, YOU KNOW, KIND OF POINTING TO SYMPTOM MANAGEMENT. I THINK IT NEEDS TO BE NOT ONLY REMOVING THAT
SENTENCE THAT WAS ON IT BUT ALSO REPLACING IT WITH A STATEMENT THAT SAYS THAT THIS CAN
BE HARMFUL BECAUSE IF YOU’RE READING THIS FOR THE FIRST TIME AND YOU’RE UNFAMILIAR WITH
OUR DISEASE, YOU MAY NOT KNOW THAT THIS IS HARMFUL. YOU REMOVED IT, BUT PEOPLE DON’T KNOW THAT
IT’S HARMFUL, COULD BE HARMFUL TO PATIENTS, UNLESS IT’S CLEARLY STATED.>>ERMIAS BELAY: THANK YOU FOR THE COMMENTS.>>I MEAN, I WILL GO BACK AND REREAD THE GENERAL
PUBLIC TO BE SURE, BUT IT’S VERY CLEAR IN WHAT WE’RE DEVELOPING BECAUSE THIS HAS BEEN
THE BIGGEST POINT OF CONFUSION, AND WE WANT TO MAKE SURE THAT EXERCISE IS A CONCERN AND
CAN BE HARMFUL, AT THE SAME TIME GIVE PEOPLE THAT HAVE — PROVIDE THE INFORMATION ABOUT
MAINTAINING EXERCISE AND ACTIVITY THROUGH THE ACTIVITY MANAGEMENT APPROACH.>>I JUST WANT TO BE CLEAR THAT IF IT’S NOT
STATED IN THERE THAT EXERCISE OR EXERTION CAN BE HARMFUL, THEN IT’S NOT CLEAR.>>IT IS STATED. IT IS STATED.>>WE’RE GETTING FEEDBACK THAT IT’S NOT CLEAR.>>OKAY. WELL, I’LL LOOK AT THE GENERAL PUBLIC, BUT
FOR SURE, IT’S IN THE — WE HAVE STATEMENTS LIKE THAT.>>ERMIAS BELAY: IN THE CLINICIAN VERSION
THAT WILL BE CLEARED IN JANUARY.>>WELL, WHEN IT’S PUBLISHED, BUT THIS IS
JUST THE FEEDBACK WE’RE GETTING FROM FOLKS.>>ERMIAS BELAY: THANK YOU. THE OTHER ACTIVITY THAT WE HAD WAS WE HAD
THE STAKEHOLDER ENGAGEMENT COMMUNICATION CORE, WHICH WE USED TO CALL — IN THE PAST, THIS
IS THE TENSE CORE, AND WE HAD IT IF ON NOVEMBER 2 AND INVITED SPEAKERS, PARTICIPANTS, INCLUDED
DR. ELLEN CLAYTON, WHO WAS THE CHAIRPERSON TO
THE INSTITUTE OF MEDICINE COMMITTEE FOR ME/CFS, AND DR. LUCINDA BATEMAN THAT WAS JUST SWORN IN, AND
DR. PETER ROLL PRESENTED DURING THE COMMUNICATION
CORE. THE TOPIC OF THEIR PRESENTATION WAS TAKE-HOME
MESSAGES FROM THE 2015 CAN INSTITUTE OF MEDICINE REPORT ON ME/CFS, AND THAT WAS VERY WELL RECEIVED,
THERE ARE ABOUT 120 CORE LINES THAT ARE AVAILABLE DURING THIS COMMUNICATION CALL, INDIVIDUALIZED
LINES, BUT MULTIPLE PEOPLE MAY BE PARTICIPATING IN ONE LINE, SO IT’S A BIG REACHOUT TO THE
COMMUNITY. THE AUDIO FILES AND THE TRANSCRIPT IS POSTED
ON OUR WEBSITE, SO PEOPLE CAN GO BACK AND LISTEN TO THE PRESENTATION AGAIN. THE TRANSMIT FOR THE PREVIOUS CALL, THE 9TH
STAKEHOLDER ENGAGEMENT COMMUNICATION CALL IS ALSO ON OUR WEBSITE. NOW, THE OTHER EVENT THAT WE HAD IS A LIVE
CONTINUING EDUCATION EVENT THAT WE HOSTED IN ATLANTA, AND THAT WAS FOLK UGLIED ON THE
AWARD-WINNING DOCUMENTARY “UNREST,” WE SECURED THE SCADSHOW A THEATER FOR SCREENING THE MOVIE,
THE DOCUMENTARY, WHICH ALSO INCLUDED A PANEL DISCUSSION RIGHT AFTER THE FILM WAS SCREENED. THE “UNREST” DOCUMENTARY WAS A VERY WONDERFUL
DOCUMENTARY, ARE WHICH I STRONGLY RECOMMEND FOR PEOPLE TO WATCH IF YOU HAVE NOT WATCHED
IT, IT WAS PRODUCED BID JEN BREA, WHO WAS THE ACTOR AND ALSO THE PRODUCER, AND SHE CHRONICLES
HER LIFE AS A HIGH-FUNCTIONING PH.D. HARVARD STUDENT UNTIL SHE BECAME A VICTIM OF ME/CFS,
AND IT’S VERY WELL DONE AND THE KIND OF TOOL THAT WE NEED TO RAISE AWARENESS FOR ME/CFS,
SO I STRONGLY RECOMMEND FOR PEOPLE TO WATCH IT.
AND I HERE HEAR THAT MAY BE IN THE RUNNING IN THE SHORT LIST FOR THE OSCARS, TOP 15 FOR
THE OSCARS FOR THIS YEAR, SO ANOTHER REASON TO WATCH THE OSCARS. NOW, THE EVENT THAT WE HOSTED, WE OBTAINED
CONTINUING EDUCATION APPROVAL FOR IT FOR VARIOUS PROFESSIONALS INCLUDING LISTED OVER THERE,
NURSES, DOCTORS, PHARMACISTS, OTHER PROFESSIONALS, TO ENCOURAGE THEM TO COME TO THE EVENT, SO
ANY ONE OF THEM WHO FALL UNDER THOSE CATEGORIES COULD POTENTIALLY OBTAIN A CE IF THEY ATTENDED
THE EVENT. AND WE SCREENED A PBS EDITED VERSION OF THE
DOCUMENTARY WHICH IS A LITTLE BIT LONGER THAN ONE HOUR, IT WAS VERY WELL RECEIVED, OVER
100 PEOPLE PARTICIPATED, CAME TO THE EVENT, THE PANEL DISCUSSION WAS PROVIDED BY DR. UNGER, DR. NANCY KLIMAS AND DR. JEN BREA HERSELF WAS AT THE EVENT. NOW, THERE WERE VARIOUS PRESENTATIONS THAT
OUR STAFF PARTICIPATED IN SINCE THE LAST MEETING, THEY ARE LISTED ON THE SLIDE. THE IMMUNOGENOMICS 2017 CONFERENCE IN OCTOBER
THAT DR. UNGER PRESENTED, A SORT OF ME/CFS INITIATIVE
THINK TANK THAT TOOK PLACE AT TYSON’S CORNER HERE IN VIRGINIA, AND THE 2017 ANNUAL MEETING
OF APHA. APHA AS YOU KNOW IS THE LARGEST GATHERING
OF PUBLIC HEALTH PROFESSIONALS GIVING US THE OPPORTUNITY TO RAISE AWARENESS ABOUT ME/CFS. THIS YEAR THE APHA CONFERENCE WAS HELD IN
ATLANTA, WHICH WAS VERY CONVENIENT, AND OUR STAFF PARTICIPATED IN THE CONFERENCE IN VARIOUS
CAPACITIES. DR. LILY CHU FOR EXAMPLE HAD A SPECIAL SYMPOSIUM
ORGANIZED ON ME/CFS, EPIDEMIOLOGIC APPROACHES TO CAPTURING HETEROGENEITY IN ME/CFS AND OUR
STAFF PARTICIPATED IN THAT ALONG WITH OTHER ORAL AND POSTER PRESENTATIONS AT THE CONFERENCE. OTHER ACTIVITIES WE PARTICIPATED IN, WE HAD
OUR ANNUAL MCAM MEETING, SO RECEIVED FUNDS FROM THE SEVEN DIFFERENT MULTICLINIC SITES,
ACTUALLY CAME TO ATLANTA ON DECEMBER 8, AND WE HAD THAT ANNUAL MEETING. UNFORTUNATELY, IT HAPPENED ON THE SAME DAY
AS SNOW WAS DUMPING ON ATLANTA, AND THAT SOMEHOW AFFECTED OUR MEETING, BUT DESPITE THE SNOW,
WE WERE ABLE TO COMPLETE THE MEETING AND WE HAD TO CUT IT SHORT, DIDN’T GO THROUGH THE
WHOLE DAY, BUT WE GOT WHAT WE WANTED TO GET OUT OF THAT MEETING. IT WAS FOCUSING ON GATHERING INFORMATION,
ENROLLING INFORMATION ON YOUNG PATIENTS WITH ME/CFS IN CONTROL AND COMPARISON GROUPS FOR
THOSE PATIENTS GOING FORWARD. NOW, WE’RE PLANNING TO HAVE A CONTINUING HE
HAD CAKES MODULE IN COLLABORATION WITH WEBMD AND MEDSCAPE WITH A TARGET LAUNCH OF MAY 2018
AND I WANT THAT TO BE A CE ACTIVITY, CONTINUING EDUCATION ACTIVITY. CAN WE WOULD LIKE TO HAVE IT MODERATED PANEL
DISCUSSION BETWEEN HEALTHCARE PROVIDERS AND FOCUS ON THE DIAGNOSTIC CRITERIA THAT’S DEVELOPED
BY THE IOM COMMITTEE. WE ALSO ARE PLANNING TO HAVE THE ROUNDTABLE
PROCESS, STAKEHOLDER ENGAGEMENT, THE WAY WE DID IT IN THE PAST AND SOME OF YOU IN THIS
ROOM PARTICIPATED IN THAT AND WE’RE PLANNING TO HAVE ANOTHER ONE AND WE’VE CONTRACTED WITH
MCKING ASSOCIATES THAT ACTUAL HOSTED OR HELPED US HOST THE FIRST STAKEHOLDER ENGAGEMENT MEETING
AND THEY’LL HELP US TO HOST ANOTHER ONE, I DON’T THINK WE’VE DECIDED ON A DATE YET, BUT
AS SOON AS WE DO, WE’LL ANNOUNCE IT AND INVITE PEOPLE TO PARTICIPATE.>>SORRY. THIS IS TERRI. CAN I ASK A QUESTION? SO FOR THE NEXT ROUNDTABLE, WHEN YOU SAY ANNOUNCE
IT, IS THAT PEOPLE CAN LET YOU KNOW THAT THEY’RE INTERESTED IN PARTICIPATING OR IS THAT KIND
OF AN INVITATION ONLY SITUATION?>>ERMIAS BELAY: WE CAN’T POSSIBLY INVITE
EVERYBODY, CLEARLY. SO WE WOULD LIKE TO HAVE AS MANY PATIENT REPRESENTATIVES
AS POSSIBLE FROM THE DIFFERENT COMMUNITIES, DIFFERENT PATIENT COMMUNITIES. LAST TIME, REMIND ME, BETH, HOW MANY PEOPLE
PARTICIPATED? PROBABLY AROUND 30 OR 40? WE ARE LIMITED BY THE VENUE. WE ARE LIMITED BY FUNDS. WE ARE LIMIT BY SEVERAL THINGS, BUT WE WOULD
LIKE TO ACCOMMODATE AS MANY PATIENT COMMUNITY REPRESENTATIVE AS POSSIBLE.>>RIGHT. ALTHOUGH THIS TIME OUR FOCUS IS A LITTLE BIT
DIFFERENT AND WE’RE GOING TO BE TRYING TO ENCOURAGE MORE OF THE HEALTHCARE PROFESSIONALS. WE WILL HAVE PATIENT INPUT FOR SURE, BUT IT’S
GOING TO BE WEIGHTED A LITTLE BIT MORE TO THE HEALTHCARE PROFESSIONALS BECAUSE WE’RE
REALLY FOCUSING ON THEIR EDUCATIONAL NEEDS AND HOW TO GET THEIR COMMUNITIES ENGAGED IN
UNDERSTANDING AND THE PATIENT SUPPORT WILL BE THERE BECAUSE YOU NEED CLEARLY A PATIENT
UNDERSTANDING, BUT THIS ROUNDTABLE FOCUS IS SLIGHTLY DIFFERENT THIS YEAR. SO IF THERE WAS A PATIENT THAT WORKS IN CLINICAL
EDUCATIONS WHO –>>YES, YES, ABSOLUTELY. WE APPRECIATE YOUR EXPERTISE AND APPRECIATE
ALL THE CONTRIBUTIONS YOU’VE ALREADY MADE.>>BUT I GUESS I’M TRYING TO UNDERSTAND THE
PROCESS. DO YOU APPLY TO BE ON IT OR —
>>THIS ISN’T SOMETHING THAT WE’VE ASKED FOR APPLICATIONS. IT’S ALWAYS HELPFUL TO KNOW THAT PEOPLE ARE
INTERESTED. WE USUALLY REACH OUT AND ASK FOR PEOPLE’S
RESPONSES AND SOMETIMES PEOPLE SAY THEY CAN DO IT OR THEY CAN’T DO IT AND REFER TO OTHER
PEOPLE, SO YES, FEEL FREE TO REACH OUT TO US BECAUSE WE ALWAYS ARE LOOKING FOR PEOPLE,
AND IF IT DOESN’T WORK OUT FOR THIS PROJECT, THERE WILL BE OTHER PROJECTS. BUT YES. IT WASN’T GOING TO BE AN OFFICIAL OPEN UP. WE DO HAVE YOUR NAMES. A LOT OF PEOPLE.>>BETH, WOULD THIS BE APPROPRIATE FOR SCHOOL
NURSES?>>THAT’S A GOOD QUESTION. WE HAD BEEN FOCUSING AGAIN ON HEALTHCARE PROFESSIONALS
FOR THE MOST PART, BUT SCHOOL NURSES WOULD BE PART OF THAT. SO WILL WE’RE VERY EARLY ON IN THE PROCESS,
JUST HAD OUR FIRST MEETING. WE JUST WANTED TO ANNOUNCE THAT WE’RE GOING
IN THAT DIRECTION, AND PART OF THE PROCESS IS, YOU KNOW, YOU HAVE AN IDEA OF WHAT YOU’RE
GOING TO DO, FOCUSING ACTUALLY TO BE VERY CLEAR ABOUT WHAT THE OBJECTIVES ARE AT THE
END, SO WE’RE EARLY ON IN THAT. IN OUR PRIOR ROUNDTABLE WE DID HAVE NURSING
REPRESENTED BUT NOT SCHOOL NURSES, PER SE.>>THANK YOU.>>ERMIAS BELAY: IT WILL HELP US TAILOR OUR
EDUCATIONAL MATERIAL THAT WOULD BE PRODUCING TO THE NEEDS OF THE CLINICAL COMMUNITY AND
FOCUSING ON THE IOM AND SPREADING THE WORD ABOUT THE IOM DIAGNOSTIC CRITERIA TO THE CLINICIAN
COMMUNITY. WE’VE COLLABORATING WITH OTHER HHS AGENCIES
AND DIFFERENT ACTIVITIES INCLUDING PARTICIPATION IN THE VARIOUS CFSAC WORKING GROUPS, PEDIATRIC
EDUCATION WORKING GROUP, MEDICAL EDUCATION WORKING GROUP AND FOLKS FROM THOSE WORKING
GROUPS WILL BE PRESENTING DURING THIS CFSAC MEETING. WE’VE BEEN WORK WITH NIH, WE’VE CO-FUNDED
THE COMMON DATA ELEMENT PROJECT WITH NIH AND THERE HAVE BEEN SOME ACTIVITIES WHICH I’M
SURE DR. VICKY WHITTEMORE WILL BE PRESENTING DURING
HER UPDATE TOMORROW. AND HER AND DR. BETH UNGER HAVE BEEN ACTIVELY ENGAGED AND
DIFFERENT DOMAINS HAVE BEEN IDENTIFIED FOR THE COMMON DATA ELEMENT PROJECT. AND WE ALSO PARTICIPATED WITH THE FDA WITH
THE DRUG DEVELOPMENT QUALIFICATION PROGRAM, WE’VE COLLECTED DATA AS PART OF THE MCAM STUDY
FOR USE IN THAT QUALIFICATION PROGRAM. FOCUSING ON THE CFSAC RECOMMENDATIONS FROM
THE PAST, AND DR. FAITH NEWTON TOUCHED UPON SOME OF THESE, THE
TWO RECOMMENDATIONS THAT WE THOUGHT RELEVANT TO CDC INCLUDED THE RECOMMENDATION THAT WAS
GIVEN BY THE CFSAC IN THE PAST TO WORK WITH THE CENTER FOR PARENT INFORMATION RESOURCES,
THIS CENTER WORKS WITH THE DEPARTMENT OF EDUCATION, THEY ACTUALLY SPECIFICALLY RECEIVE FUNDING
FROM THE DEPARTMENT OF EDUCATION TO REACH OUT TO PARENTS AND PROVIDE RESOURCES TO PARENTS
AND WE’VE BEEN WORKING WITH THEM TO TRY TO IDENTIFY — I MEAN, DEVELOP ME/CFS WEBSITES
TAILORED SPECIFIC TO THE EDUCATION NEEDS OF YOUNG ME/CFS PATIENTS. PARENTS COULD POTENTIAL USE THOSE RESOURCES. THEY WORK WITH THE SCHOOL SYSTEM TO TRY TO
ENGAGE IN MAXIMUM EDUCATION FOR THEIR CHILDREN. AND THOSE RESOURCES ARE BEING DEVELOPED AND
THE CENTER FOR PARENTS INFORMATION WEBSITE WILL INCLUDE INFORMATION ON THEIR WEBSITE
REGARDING THE EDUCATIONAL NEEDS. NOW, THE OTHER RECOMMENDATION HAD TO DO WITH
DEVELOPMENT OF TREATMENT GUIDELINES FOR ME/CFS. BY NO MEANS, THIS IS SPECIFIC TO CDC BECAUSE
CDC ALONE CANNOT DO IT, BUT WE WANTED TO TAKE THE INITIATIVE TO DEVELOP A PLAN TO HOW TO
ADDRESS THIS ISSUE AND HOW TO DEVELOP THE GUIDELINES AND WE HAVE INITIATED THAT PROCESS
WITH A TARGET DATE OF EARLY 2018. WE WOULD LIKE TO PRESENT THE OPTIONS FOR DIFFERENT
WAYS OF DEVELOPING THOSE GUIDELINES, PRESENT IT TO THE DIFFERENT EX-OFFICIOS WITHIN HHS
TO TAKE IT FORWARD. WE HAVEN’T FINALIZED ANY PLAN AT ALL AT THIS
POINT, BUT WE ARE THINKING THROUGH DIFFERENT OPTIONS AND BETH UNGER, WHO IS HEAVILY INVOLVED
IN DEVELOPING THIS PLAN, MAY EXPAND ON THIS, BUT AS I SAY, BY EARLY 2018, WE WOULD LIKE
TO HAVE THE PLAN DEVELOPED THAT WE COULD PRESENT TO OTHERS ON DEVELOPING THIS GUIDELINE GOING
FORWARD. BETH, ANYTHING YOU WOULD LIKE TO ADD?>>YES, I GUESS. WE HAVE BEEN ACTIVELY WORKING ON THIS. IT’S A BIG QUESTION, AND RIGHT AFTER THE MEETING
WE WERE FORTUNATE THAT CDC’S OFFICE FOR ASSOCIATION — OFFICE OF THE ASSOCIATE DIRECTOR FOR SCIENCE,
OADS, DEVELOPED AN INFORMATIONAL PROGRAM ABOUT GUIDELINE DEVELOPMENT BECAUSE IT’S NOT JUST
OUR GROUP, A LOT OF GROUPS AT CDC NEED OR CONSIDER DEVELOPING GUIDELINES. SO THE PROCESS FOR THIS IS EVER-EVOLVING. SO THEY HAD A PRESENTATION THAT WAS AVAILABLE
TO GO AND TALK TO DIFFERENT GROUPS, SO WE INVITED THEM TO OUR GROUP AND THEY GAVE US
A REALLY GOOD OVERVIEW OF THE ENTIRE PROCESS, AND WE FOLLOWED UP WITH THEM AND WE’VE DONE
THE INITIAL PRELIMINARY THINGS LIKE COMPLETING A FORM THAT WALKS YOU STEP BY STEP SORT OF
DECISION TREES, SHOULD WE DEVELOP GUIDELINES, ARE THEY NEEDED AND THOSE KIND OF THINGS,
WE’VE GOTTEN THAT FAR. WE’VE MET WITH THE MANAGEMENT OF ANALYSIS
AND SERVICES OFFICE, MASO, FOR SOME OF THE DECISIONS. AS YOU KNOW, GUIDELINES NEED TO BE BASED ON
EVIDENCE, AND IN MOST SITUATIONS THIS IS ON PUBLISHED PEER REVIEW SCIENTIFIC ARTICLES,
AND WE FEEL THAT FOR ME/CFS THAT WILL BE INSUFFICIENT, AS MUCH OF THE KNOWLEDGE IS AT THE LEVEL OF
EXPERT OPINION. SO WE SPENT A LOT OF — WE ARE STILL ASKING
QUESTIONS ABOUT WHAT WILL BE THE BEST WAY TO ACCOMMODATE THIS KIND OF INFORMATION SO
THAT IT’S NOT LOST, AND ALL OF THE RULES FOR GETTING EXPERT OPINION INTO THE FEDERAL GOVERNMENT
ARE VERY, VERY COMPLEX. SO WE REALIZE THAT THERE AGAIN WILL BE ON
A CYCLE OF FINESSING AND REFINING SPECIFICALLY THE QUESTIONS AND WHAT THE CHARGE TO THE WORKING
GROUPS THAT WILL BE APPROACHING THIS WILL BE, THE CHARGE BEING EXACTLY HOW MANY QUESTIONS
WE’RE ASKING, WHO ARE WE DEVELOPING THE ANSWERS FOR, IN OTHER WORDS, WHAT SORT OF CLINICIANS
AND UNDER WHAT CLINICAL SITUATION. SO IT’S A MULTI, MULTI-STEP PROCESS. WE’VE ALSO BEEN GIVEN GUIDANCE TO NOT EXPECT
IT TO BE HAPPENING FAST. AND WE BELIEVE THAT IT’S WORTH THE TIME THAT
IT WILL TAKE TO INVEST TO GET THE FIRST OF THESE GUIDELINES IN PLACE. AND ONCE THE GUIDELINES ARE IN PLACE, IT’S
CLEAR THAT THERE IS SORT OF BY MANDATE, THEY CAN’T STAND FOR MORE THAN THREE YEARS WITHOUT
BEING REVIEWED AND REVERIFIED. SO ONCE THEY’RE IN PLACE, THERE WILL BE A
PROCESS FOR CONTINUAL UPDATING. AND THAT’S WHERE WE’RE AT. OTHER THAN TO REEMPHASIZE, THIS CAN’T BE CDC’S
PROJECT ALONE, WE’LL BE RELYING ON THE CONTRIBUTIONS AND WORK OF THE EX-OFFICIOS AND THE COMMUNITY
AT LARGE.>>QUESTIONS FOR DR. BELAY OR DR. UNGER?>>HI. DR. BELAY AND UNGER —
>>YOU NEED TO TELL WHO IS SPEAKING.>>SORRY, COURTNEY MILLER, WITH SIMMARON RESEARCH. I WANT TO RECOGNIZE BOTH OF YOU AND YOUR TEAMS’
WORK BOTH TO INTEGRATE STAKEHOLDER P PATIENT, EXPERT OPINIONS AND EXPERIENCE IN THE REVAMPING
OF THE WEBSITE, I’M PARTICULARLY THAT YOU WERE ABLE TO USE “UNREST” AS A CONTINUING
EDUCATION PROMPT IN THE COMMUNITY, AND I WANT TO ASK SOMETHING THAT YOU DIDN’T REPORT ON,
IT WAS AN EXTENSIVE REPORT AND I’M GLAD TO HEAR ALL OF THE WORK THAT YOU’RE DOING. ON THE MCAM STUDY, THE MULTISITE STUDY, YOU
KNOW, I THINK YOU GUYS HAVE, THE CDC HAS THE MOST COMPREHENSIVE, WELL CONSTRUCTED, LARGEST
SET OF DATA ON PATIENTS WITH THIS DISEASE AND MATCHED CONTROLS, AND WE’RE VERY EAGER
TO SEE MORE OF IT PUBLISHED. I KNOW YOU HAVE THAT ON YOUR SET OF LISTS,
BUT IF THE QUESTION IS RESOURCES, YOU KNOW, HOW CAN WE FIGURE OUT A WAY TO GET STAFF TIME
OR ANALYSIS TIME AND SOME EXPERT INPUT WITHIN THE GOVERNMENT AND DIFFERENT AGENCIES, HOW
DO WE MOVE THAT FORWARD? I APPRECIATE THE SHARING OF IT WITH I THINK
BOTH THE NIH INTRAMURAL STUDY AND YOU ALLUDED TO THE FDA OUTCOME MEASURES, BUT THERE’S A
WEALTH OF KNOWLEDGE IN WHAT YOU HAVE. SO HELP US FIGURE OUT HOW TO HELP YOU GET
IT OUT AND GET IT PUBLISHED.>>THANK YOU. I APPRECIATE THAT. WE ARE VERY AWARE THAT THE CLOCK IS TICKING
AND THAT WE HAVE THIS GREAT DATA AND WE NEED TO GET IT OUT. WE ARE WORKING WITH OUR GROUP, AND I THINK
YOUR SUGGESTION TO REACH OUT AND FIND OTHER EXPERTISE AS NEEDED IS WISE, AND WE WILL DO
THAT. THE NEXT MANUSCRIPT THAT’S IN PREPARATION
IS AGAIN DESCRIPTIVE OF THE HETEROGENEITY OF THE PATIENTS BECAUSE I THINK THAT THAT’S
ONE AREA THAT EVEN RESEARCHERS WHEN THEY COME INTO THE FIELD JUST DON’T REALIZE, SO WE’RE
GOING TO BE — THAT IS IN PREPARATION, AND HOPEFULLY IT WILL GO FAST. AND THEN I THINK SOME OF THE OTHER ONES WE
ARE WAITING FOR COMPLETE DATA, LIKE ONE OF THE MOST — WELL, EVERYTHING IS IMPORTANT,
BUT WE’RE LOOKING FORWARD TO CONTRIBUTING DATA ON THE END CASE FUNCTION TESTING, BUT
WE NEED TO FINISH THE TESTING, SIMILARLY FOR THE EXERCISE, WE NEED TO COMPLETE A SET, AND
FOR THE MORNING CORTISOL DATA, WE’RE WAITING UNTIL WE HAVE A COMPLETE SET. SO THERE ARE SOME THINGS WHERE WE HAVE A LOT
OF DATA BUT IT’S NOT READY TO PUT OUT. NOW, EVEN INTERIM ANALYSES CAN BE REALLY HELPFUL
AND RAISE INTEREST ABOUT THE APPROXIMATE PROJECT AND THE FIELD AND I DID WANT TO ADD ONE ADDITIONAL
COMMENT TO THE IMMUNOGENOMICS MEETING THAT I PRESENTED AT, THIS WAS VERY, VERY PRELIMINARY
DATA, THESE WERE SCIENTISTS INTERESTED IN REALLY HIGH-TECH APPROACHES TO IMMUNOLOGY,
AND THEY WERE VERY FASCINATED ABOUT THE PROBLEM OF ME/CFS. I’VE NEVER HAD A GROUP OF PEOPLE BE SO INTERESTED. SO IT’S ENCOURAGING THAT WHEN YOU GO AND YOU
PRESENT A START OF SOME INFORMATION, OTHER SCIENTISTS ARE GOING TO START TO RESPOND. SO ALL OF THOSE EFFORTS ARE IMPORTANT, AND
WE’RE MOVING FORWARD.>>THANK YOU.>>I WOULD I LIKE TO THANK DR. UNGER AND DR. BELAY FOR THE WORK THEY’VE DONE THE LAST COUPLE
OF MONTHS SINCE THE LAST CDC MEETING. I THINK YOU’VE MADE AN INCREDIBLE AMOUNT OF
PROGRESS AND I THINK THE COMMUNITY IS VERY PLEASED WITH WHAT’S GOING ON.>>ERMIAS BELAY: THANK YOU.>>FAITH NEWTON: ANY OTHER QUESTIONS? OKAY. LET’S MOVE ON TO THE FDA.>>SO WE HAVE FROM KEITH, WHO USED TO BE THE
ALTERNATE TO JANET, JANET IT APPEARS HAS MOVED TO ANOTHER POSITION AND NOW WE HAVE KEITH
REPRESENTING THE FDA.>>KEITH HULL: THANK YOU. I APPRECIATE THE OPPORTUNITY ON SHARE THE
FDA’S ACTIVITIES SINCE OUR LAST MEETING. THANK YOU. ONE MORE. OKAY. SINCE LAST JUNE, THE AGENCY HAS MET WITH TWO
SPONSORS REGARDING DRUG DEVELOPMENT PROGRAMS FOR THE TREATMENT OF ME/CFS, OF WHICH ONE
HAS LED TO A NEW TREATMENT IMD, I CAN’T REVEAL OF ANY MORE OF WHAT WE MET WITH, BUT THAT’S
PROMISING THAT WE HAVE HAD ONE NEW IMD. SECOND UPDATE IS REGARDING THE CLINICAL UPDATE
ASSESSMENT PROGRAM WHICH DR. BELAY MENTIONED, THIS PROGRAM FACILITATES
A COLLABORATIVE SETTING WHERE THE FDA WORKS WITH STAKEHOLDERS IN GUIDING CLINICAL OUTCOME
ASSESSMENT DEVELOPMENT SO THEY CAN DEVELOP NEW OUTCOMES FOR CLINICAL TRIALS. THERE ARE MULTIPLE INTERESTED PARTIES OFTEN
WORK TOGETHER IN WORKING GROUPS TO DEVELOP A CLINICAL OUTCOME ASSESSMENT FOR QUALIFICATION,
AND THIS ALLOWS FOR SHARING OF RESOURCES AND HELPS FACILITATE NEW OUTCOMES WHICH THE FDA
WILL TRY TO HAVE SPONSORS USE. SO LAST YEAR THE PROMIS NETWORK CENTER OF
THE AMERICAN INSTITUTES OF RESEARCH MADE AN INITIAL PACKAGE FOR REVIEW REGARDING A PLAN
TO CONDUCT QUALITATIVE RESEARCH USING PROMIS FATIGUE BANK WITH PATIENTS WITH ME/CFS WE
DISCUSSED THE RECENTLY COLLECTED DATA FROM THE CDC AND REACHED OUT TO THEM FOR COLLABORATION
BETWEEN THE GROUPS AND AS DR. BELAY HAD MENTIONED, THAT THIS SUMMER THE
CDC AND THE PROMIS INVESTIGATORS AGREED TO COLLABORATE TO FURTHER EXAMINE THE DATA FROM
THE CDC’S PATIENT STUDY THAT MAY HELP TO IDENTIFY GAPS IN ANY EXISTING EVIDENCE AND TO ALLOW
FOR A PLANNED QUALITATIVE RESEARCH TO ADDRESS THE GAPS. SO HOPEFULLY WHAT IT WILL DO IS COME UP WITH
SOME NEW PATIENT REPORTED OUTCOME USING THE PROMIS FATIGUE SCALE THAT WILL AGAIN JUST
PROVIDES ANOTHER ENDPOINT THAT CAN BE USED IN A CLINICAL TRIAL FOR ANY INTERESTED PARTIES
TRYING TO DEVELOP DRUGS. AND THAT, WE’VE HAD A COUPLE IN SERVICES AS
WELL FOR KNEW NEW REVIEWERS WHO HAVE ENTERED OUR DIVISION WHO ARE REVIEWING FOR CHRONIC
FATIGUE. ANY QUESTIONS?>>THIS IS TERRI WILDER. IS THE FDA WORKING WITH ANY OTHER INSTITUTIONS
BESIDE THE CDC?>>KEITH HULL: NOT DIRECTLY. I THINK THERE IS SOME FACILITATION BETWEEN
NIH IF THEY COME TO US AND NEED INPUT ON WHAT THEY WOULD NEED FOR A TRIAL, BUT THAT IS PRIMARILY
THE OTHER AGENCY. RIGHT NOW IT’S CDC AND I THINK OCCASIONALLY
NIH.>>SO THIS IS COURTNEY MILLER. I THINK DR. MAYNARD KNOWS MORE OF MY AND MY HUSBAND’S
BACKGROUND IN THIS DISEASE AND THE FDA, YOU KNOW, I HAVE A COUPLE OF QUESTIONS AND A COUPLE
OF POINTS. ONE IS IF IT IS THE ESSENTIAL NEED TO WORK
THE EXISTING CLINICIANS, EXPERT CLINICIANS, IN WHATEVER OUTCOME MEASURE PACKAGE, PROCESS
YOU ARE WORKING ON, I GUARANTEE YOU IF IT’S SOME OUTSIDE ORGANIZATION DEVELOPING SOME
MEASURE ON ITS OWN, WE ARE GOING TO MISS THE MARK. WE HAVE MISSED THE MARK FOR 30 YEARS. WE CAN’T AFFORD TO DO THAT THIS TIME. SO I HOPE THIS PROCESS IS SUBSTANTIAL AND
IS BUILT AROUND STAKEHOLDERS, INCLUDING PATIENTS. OUR EXPERIENCE WITH THE ONLY DRUG THAT’S BEEN
IN CLINICAL TRIALS FOR 25 YEARS HAS BEEN DISASTROUS WITH RESPECT TO A LICENSING PROCESS. WE IN THE FIELD, THE PATIENTS NEED A FIRST
DRUG APPROVED BY THE FDA. IT IS A PRECONDITION TO GETTING PHARMACEUTICAL
INVESTMENT IN THIS DISEASE TO SEE THAT THE FDA IS ACTUALLY WILLING TO APPROVE A MEDICATION
FOR THIS DISEASE. SO IN OUR EXPERIENCE, IT’S VERY PERSONAL. MY HUSBAND CAN’T LEAVE THE HOUSE BECAUSE AMPLIGEN
IS ALL BUT GONE AFTER THE DENIAL THAT FDA MADE FIVE YEARS AGO, FIVE YEARS AGO THIS MONTH. SO THE PROGRESS NEEDS TO BE MUCH MORE SUBSTANTIAL,
AND I APPRECIATE THE REPORT. I’M GLAD THERE’S A PROJECT YOU’RE WORKING
ON AT FDA, BUT WE NEED TO MOVE THIS FORWARD, AND IT DOESN’T HAPPEN OVERNIGHT. I UNDERSTAND THAT. SO I GUESS ONE OF THE THINGS I WANTED TO RAISE
IN THE CONTEXT OF THIS COMMITTEE MEETING FOR THE COMMITTEE IS, YOU KNOW, HOW DO WE PUT
TOGETHER A WORKING GROUP THAT ADDRESSES WHAT WE NEED TO DO ACROSS AGENCIES TO BRING CLINICAL
TRIALS, TREATMENT TRIALS, TO PATIENTS. WE’RE NOT GOING TO LEARN WHAT WORKS UNTIL
WE START TRYING IT, AND IT’S NOT HAPPENING BY NATURE OF THE FREE MARKET. THAT IS NOT WORKING. SO ON PARTICULARLY FEEDBACK TO THE FDA, I
REALLY HOPE THAT AS THE SIX-MONTH MEETINGS PROGRESS HERE, WE CAN HEAR A MORE FULL AND
DETAILED PLAN OF HOW YOU CAN STRETCH YOUR AGENCY AND MOVE THIS FOR OUR DISEASE, MOVE
ANY NUMBER OF THINGS, ATTRACT PHARMACEUTICAL INDUSTRY, REACH OUT TO THEM, FIGURE OUT WHAT
— OUTCOME MEASURES ARE CRITICALLY IMPORTANT, BUT FIGURE OUT HOW WE INTEGRATE OUR COMMUNITY
AND OUR EXPERTS MOSTLY INTO THAT, AND THEN FOR THE COMMITTEE, I WOULD REALLY LIKE TO
PUT FORWARD NOW OR LATER IN THE AGENDA HOW WE PUT A WORKING GROUP TOGETHER THAT PLANS
BIG AND SMALL, WHATEVER IT IS THAT WE CAN DO TO HAVE THE FEDERAL AGENCIES TALKING TO
PHARMACEUTICAL COMPANIES, LAYING OUT, ASKING WHAT DO WE NEED TO CREATE CLINICAL TRIALS
IN THIS DISEASE. YOU KNOW, WE ARE BARREN, THE FIELD IS NOT
TILLED, IT’S NOT EVEN — IT’S NOT FERTILIZED, IT’S NOT — EXCEPT THAT IT’S WIDE OPEN AND
WE HAVE PATIENTS WILLING TO DO CLINICAL TRIALS, WILLING TO MOVE TO DO CLINICAL TRIALS. I MEAN, IT’S A DESPERATE NEED. I DON’T KNOW WHEN FOR THE COMMITTEE’S SAKE
WE WANT TO TALK ABOUT, YOU KNOW, I’LL DO THE WORK, I WOULD LIKE THE AGENCIES, ESPECIALLY
NIH, CDC TO BE PART OF THE DISCUSSION OF WHAT CAN WE DO ACROSS THE FEDERAL AGENCIES TO ATTRACT,
CREATE THE MOMENTUM TOWARDS TREATMENT TRIALS.>>FAITH NEWTON: THIS IS FAITH NEWTON. WE HAVE ON THE SCHEDULE FOR TOMORROW AFTERNOON
ABOUT 4:00 FOR NEXT STEPS AND THAT’S TYPICALLY THE TIME WE DISCUSS WORKING GROUPS AFTER WE
HEAR THE PRESENTATIONS TODAY AND TOMORROW AND WHERE WE’RE HEADED. KEITH, DO YOU WANT TO RESPOND TO COURTNEY’S
–>>KEITH HULL: I DO. I WANT TO CLARIFY. THIS PROMIS FATIGUE QUALIFICATION PROGRAM
IS A VERY SMALL PART OF SOMETHING THAT SOMEBODY THAT THESE INVESTIGATORS BROUGHT AS A GRANT
PROGRAM. THE FDA HAS ACTUALLY MET WITH SPONSORS AND
TOLD THEM FOR THE CLINICAL OUTCOME ALL THAT YOU NEED TO DO IS COME UP WITH SOMETHING THAT
SHOWS THAT THE PATIENT FIELD BETTER. IT CAN BE A QUESTIONNAIRE, IT DOESN’T MATTER
WHAT IT IS, JUST SHOW US ON THERE’S SOME MEASURE THAT YOU CAN DO IN A WELL CONTROLLED DOUBLE-BLIND
CONSTITUTED STUDY THAT SHOWS THAT THE PATIENT IS GETTING BETTER, I CAN GET OUT OF BED, I
FEEL BETTER, PLAY WITH MY CHILDREN, DOESN’T HAVE TO BE VALIDATED OR QUALIFIED. WE REALLY WANT TO MOVE THE PROCESS FORWARD. UNFORTUNATELY, THE FDA CAN’T GO OUT AND SOLICIT
PHARMACEUTICAL COMPANIES TO TRY TO MAKE A DRUG DO IT, THAT’S SOMETHING BETTER BROUGHT
BY THE PATIENT ADVOCACY GROUPS, THERE’S ENOUGH PATIENTS TO MAKE IT FINANCIALLY VIABLE FOR
THEM, BUT WE HAVE MET WITH SPONSORS AND TOLD THEM THE SERIOUSNESS OF THE DISEASE, WE’RE
GOING TO ACCEPT A LARGE AMOUNT OF RISK FORT RISK/BENEFIT PROFILE, AND THE BENEFIT DOES
NOT HAVE TO BE ANYTHING — IT’S NOT A HIGH HURDLE, SHOW THAT OVER A PERIOD OF TIME, 12
WEEKS, THAT PATIENTS FEEL BETTER W THAT SAID, WE’VE HAD ONE NEW COMPANY COME IN OR ONE NEW
INVESTIGATOR COME IN TO TRY TO PERFORM A CLINICAL TRIAL INPATIENT. THERE ARE PLENTY OF PATIENTS. WE’VE TOLD PHARMACEUTICAL COMPANIES THAT. THE PROBLEM TENDS TO BE, WHAT WE’VE SEEN IN
RESEARCH, IS GETTING THE PHARMACEUTICAL COMPANIES TO GET MOTIVATED TO GO BECAUSE THERE’S GENERALLY
A MONETARY PROFIT FOR THEM, AND WE CAN’T GO OUT AND TELL EACH COMPANY TO TRY TO DO T-N-I-H
MIGHT BE ABLE TO HELP WITH THAT TO GET A TRIAL GOING FROM AN INVESTIGATOR’S STANDPOINT, BUT
I CAN SAY FROM OUR STANDPOINT WHEN WE HAVE MET WITH SPONSORS, I DON’T WANT TO SAY LOWER
THE BAR, BUT YOU DO NOT NEED A LOT OF CLINICAL OUTCOME. THE PRIMARY ENDPOINT IS JUST SHOWING THAT
A PATIENT FEELS BETTER AND THEY CAN COME UP WITH ALMOST ANY QUESTIONNAIRE, AS LONG AS
IT AT LEAST HAS SOME FAITH VALIDITY, WE WOULD BE ACCEPTING IT. SO WE’RE REALLY TRYING TO FACILITATE ANYONE
COMING IN FOR A DRUG FOR THIS DISEASE. THAT GOES FROM THE HIGHEST LEVELS ALL THE
WAY DOWN TO OUR DIVISION. EVERYBODY AT THE FDA IS HOPING THAT SOMETHING
WILL COME THROUGH.>>FAITH NEWTON: TERRI?>>HI. TERRI WILDER. I REALIZE WE’RE GOING TO TALK ABOUT THIS LATER,
BUT I SUPPORT WHAT COURTNEY SAID IN THAT WE NEED A WORKING GROUP. I JUST HAD A QUICK QUESTION ABOUT OUTCOME
MEASURES. ARE YOU GUYS WORKING ON ANY OUTCOME MEASURES
BEYOND PROMIS?>>KEITH HULL: SO WE DON’T NECESSARILY WORK
ON THE OUTCOME MEASURE, PER SE, BUT LET’S SAY A COMPANY CAME IN AND PROPOSED A QUESTIONNAIRE
WHICH SAID, YOU KNOW, WHAT’S YOUR ENERGY LEVEL IN THE MORNING, YOU KNOW, MY DAILY ACTIVITIES,
YOU CAN GET OUT OF BED OR YOU CAN LEAVE THE HOUSE, AND IT’S A VISUAL ANALOG SCALE, ET
CETERA. WE’LL ACCEPT WHATEVER A SPONSOR IS GOING TO
PROPOSE. I MEAN, WE MAY SUGGEST AND RECOMMEND ALTERATIONS,
BUT WE WANT A PATIENT REPORT OUTCOME TO SHOW THAT A PATIENT IS FEELING BETTER. IT DOESN’T HAVE TO BE VALIDATED, IT JUST HAS
TO BE SOME TYPE OF OUTCOME MEASURE FOR THAT TRIAL. I MEAN, FROM A STUDY DESIGN, IT DOESN’T GET
MUCH EASIER THAN THAT FOR A COMPANY THAT THEY CAN PROPOSE ALMOST ANYTHING THAT WE’LL ACCEPT.

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