>> ALL RIGHT, EVERYONE.
WELCOME TO THE 17th MEETING OF
THE BRAIN NEUROETHICS WORKING
GROUP.
MY NAME IS ANDREA
BECKEL-MITCHENER, DEPUTY
DIRECTOR OF THE NIH BRAIN
INITIATIVE.
I'M SERVING AS DESIGNATED
FEDERAL OFFICIAL, DFO, FOR
TODAY'S MEETING.
I WANT TO EXTEND AN ESPECIALLY
WARM WELCOME TO OUR WORKING
GROUP CHAIRS, CO-CHAIRS, DR.
CHRIS TINE GRADY AND DR. NITA
FARAHANY.
I WANT TO WELCOME MEMBERS OF THE
WORKING GROUP ALONG WITH OUR
INVITED SPEAKERS AND GUESTS JOIN
US TODAY.
THE NEUROETHICS WORKING GROUP IS
NOT A FORMAL ADVISORY GROUP,
LIKE THE BRAIN MULTI-COUNCIL
WORKING GROUP, THE WORKING GROUP
OFS HAVE COUNCILS OF THE NIH
INSTITUTES THAT PARTICIPATE IN
THE BRAIN INITIATIVE,
ESTABLISHED FOR INPUT FOR
RESEARCH SUPPORTED THROUGH THE
BRAIN INITIATIVE, DELIBERATING
ON ETHICAL QUESTIONS IN THE
CONTEXT OF BRAIN INITIATIVE
RESEARCH AND OFFERS HELPFUL
PERSPECTIVES AND POINTS TO
CONSIDER.
SO, IN TODAY'S VIRTUAL MEETING
WE HAVE A FEW ITEMS ON THE
AGENDA, BUT FIRST WE HAVE TWO
NEW MEMBERS JOINING US.
WE WARMLY WELCOME DR. AMY
MAGUIRE AND MS. JEN FRENCH.
WE'RE GLAD YOU'RE HERE.
I BELIEVE DR. McGWIRE HAS A
CONFLICT BUT WILL JOIN US LATER
ON.
WALKING THROUGH THE AGENDA,
FIRST WE HAVE AN UPDATE FROM OUR
BRAIN DIRECTOR JOHN NGAI, AND
THEN WE'LL DEVOTE THE MAJORITY
OF TODAY'S MEETING TO TWO
SESSIONS.
THE FIRST SESSION WILL EXPLORE
ETHICAL CONSIDERATIONS AROUND
PEDIATRICS NEUROSTIMULATION, AND
IN THAT DISCUSSION WE'LL HEAR
FROM CLINICIANS AND ETHICISTS
WORKING ON THIS ISSUE.
THE SECOND SESSION WILL SCAN THE
HORIZON FOR EMERGING NEUROETHICS
OPPORTUNITIES INFORMED FROM A
PANEL OF EARLY STAGE AND
ESTABLISHED INVESTIGATORS IN THE
FIELD.
WE'LL WRAP UP, AS A WRAP-UP
WE'LL HEAR UPDATES FROM MEMBERS
ABOUT WHAT EVERYBODY HAS BEEN UP
TO SINCE WE MET IN OFFICE.
A HUE HOUSEKEEPING ITEMS BEFORE
WE GET STARTED, REMINDER THIS
OPEN SESSION IS BEING VIDEOCAST
LIVE IN THE PUBLIC DOMAIN,
REPORTING WILL BE ARCHIVED FOR
LATER VIEWING ON THE NIH AND ON
THE BRAIN WEBSITE.
PLEASE PUT YOURSELF ON MUTE.
WE ASK NEWG MEMBERS TO HAVE YOUR
CAMERA ON TO THE EXTENT YOU'RE
ABLE, BUT IT IS UP TO YOU.
DURING DISCUSSIONS TURN ON YOUR
VIDEO AND USE THE RAISE HAND
OPTION, IF YOU HAVE QUESTIONS OR
COMMENTS.
MODERATORS WILL CALL ON YOU TO
UNMUTE.
WE ASK YOU TO OPT FOR THE "RAISE
HAND" FEATURE RATHER THAN TYPING
QUESTIONS IN THE CHAT BECAUSE
VIDEOCAST ATTENDEES CANNOT SEE
OR HEAR THE QUESTIONS, THE CHAT
FUNCTION IS NOT AVAILABLE TO ALL
LISTENING IN.
EVERYONE IS BUSY AND WE
APPRECIATE YOUR TIME AND
VALUABLE INPUT THAT YOU PROVIDE
ON TOPICS BEFORE US.
FINALLY, NONE OF THIS CAN HAPPEN
WITHOUT THE REALLY TERRIFIC TEAM
WE HAVE HERE, I ESPECIALLY WANT
TO THANK DR. NINA HSU, AND WHO
TRANSITIONED TO A NEW ROLE AS
NEUROETHICS PROGRAM DIRECTOR FOR
NINDS.
SO WE CONGRATULATE HER, NINA, ON
YOUR NEW POSITION.
AND WE'RE THRILLED TO CONTINUE
TO WORK WITH YOU IN YOUR NEW
ROLE.
THE TEAM MAKING TODAY'S MEETING
POSSIBLE INCLUDES DR. SASKIA
HENDRIKS, DR. CHRISTIAN DUPAY,
AND OUR LOGISTICS AND TECH TEAM
AT ROSE LI AND ASSOCIATES
ESPECIALLY REBECCA AND HOLLY.
WE'LL WELCOME DR. JOHN NGAI,
DIRECTOR OF THE BRAIN
INITIATIVE, AND WE THANK HIM FOR
HIS SUPPORT OF NEUROETHICS.
OVER TO YOU, JOHN.
>> THANKS, ANDREA.
I'D LIKE TO ECHO THANKS TO
THOSE WHO MEET THIS POSSIBLE AND
OUR CO-CHAIRS, TO SUPPORT OUR
MISSION IN THIS SPACE, AND
THANKING NEWG MEMBERS FOR BEING
HERE.
MCWG MEMBERS HERE ON THEIR OWN
TIME TO LISTEN AND PARTICIPATE
IN TODAY'S DISCUSSIONS AND OTHER
PARTICIPANTS WHO SO GRACIOUSLY
HAVE OFFERED THEIR TIME TO BE IN
THE MEETING AND TO PARTICIPATE
IN WHAT I'M SURE WILL BE A
LIVELY DISCUSSION.
I WANT TO TAKE FIVE OR TEN
MINUTES TO GIVE BRIEF UPDATES
AND WE'LL TO THE MEAT OF THE
MATTER WITH PANEL DISCUSSIONS
AND PRESENTATIONS.
LET'S SEE.
CAN YOU SEE WHAT LOOKING TO THE
RIGHT SCREEN HERE?
ARE WE GOOD?
TO GIVE A QUICK UPDATE, ANDREA
MENTIONED TWO NEW MEMBERS, TO
THE NEWG, AS WE LIKE TO CALL IT.
FIRST DR. AMY McGUIRE FROM
BAYLOR COLLEGE OF MEDICINE,
DIRECTOR OF CENTER FOR MEDICAL
ETHICS AND HEALTH POLICY AT
BAYLOR, HAS A GREAT TRACK RECORD
AND HISTORY IN RESEARCH STUDYING
ETHICAL AND POLICY ISSUES WITH
NEUROTHERAPEUTICS AND SHE'S
QUITE ACTIVE IN LOCAL AND
SOCIETAL IMPACTS OF
NEUROMODULATION THERAPIES,
CENTRAL TO WHAT WE DO IN
"BRAIN."
SHE'S FOUNDING DIRECTOR OF
ETHICAL LEGAL IMPLICATIONS OF
PSYCHEDELIC SOCIETYING, SHE WILL
BE JOINING US SHORTLY.
NEXT UP IS JEN FRENCH, FOUNDER
AND EXECUTIVE DIRECTOR OF
NEUROTECH NETWORKS, ALSO SERVING
ON THE MULTI-COUNCIL WORKING
GROUP FOR BRAIN FOR THE PAST
YEAR PLUS, DELIGHTED TO HAVE YOU
HERE.
JEN CO-FOUNDED NEUROTECH
NETWORK, REALLY AS AN EFFICACY
GROUP TO ADVANCE THE
DISSEMINATION AND
DEMOCRATIZATION OF EMERGING
NEUROTECHNOLOGIES THAT ARE
DESIGNED TO HELP FOLKS WITH
DISABILITIES.
SO WE'RE VERY, VERY PLEASED TO
HAVE HER LEER FOR THAT TO GIVE
US AN IMPORTANT PERSPECTIVE OF
THE FOLKS THAT WE'RE TRYING TO
HELP.
JUST TO GIVE A QUICK ALERT, ON
APRIL 17-19, ETHICAL
NEUROSCIENCE MEETING, IN-PERSON
COMPONENT IN BALTIMORE, IN THE
STATES.
THE TITLE OF THIS WORKSHOP IS
BEING ORGANIZED BY DOCTORS NINA
HSU AND JAY CHURCH HILL,
DEMYSTIFYING NIH BRAIN
INITIATIVE FUNDING IN
NEUROETHICS, HELPING PEOPLE
NAVIGATE TO YOU WHO BECOME
INVOLVED IN CARRYING OUT
EMPIRICAL RESEARCH IN THE
NEUROETHICS SPACE.
WE'RE VERY LUCKY TO HAVE FOUR
BRAIN-FUNDED INVESTIGATORS
PARTICIPATE THAT MIGHT HELP
OTHERS NAVIGATE INTO THIS
EXCITING AREA OF RESEARCH THAT'S
SO CRITICAL TO MAKING SURE WHAT
WE DO IS DONE IN A GOOD WAY.
VERY EXCITED TO LET YOU KNOW
ABOUT THE UPCOMING BRAIN
INITIATIVE CONFERENCE, OUR TENTH
ANNUAL CONFERENCE, CELEBRATING A
DECADE OF INNOVATION BUT LOOKING
TO SEE HOW WE CAN BUILD ON THE
LAST TEN YEARS TO EVEN FURTHER
OUR CAUSE.
THE MAIN MEETING WILL BE HELD ON
JUNE 17 AND 18, HYBRID FORMAT,
IN-PERSON PART HELD IN NORTH
BETHESDA IN MARYLAND, AND EARLY
CAREER EVENT JUNE 16 EVENING,
MARK YOUR CALENDARS, ATTENDANCE
IS FREE SO PLEASE BEAR THAT IN
MIND.
THERE'S THE QR CODE, YOU CAN
FIND MORE DETAILS ABOUT THIS
MEETING ON THE BRAIN WEBSITE, SO
FAR SHAPING UP TO BE AN EXCITING
CONFERENCE.
A GREAT ONE LAST YEAR AS WELL.
I WANT TO LET FOLKS KNOW ABOUT
NOTICE OF SCIENTIFIC INTEREST,
NOT IN BRAIN ITSELF BUT FROM THE
OFFERS OF THE DIRECTOR NIH-WIDE.
AND THE -- IT'S A CALL FOR
RESEARCH SUPPLEMENTS TO ONGOING
GRANTS, TO SUPPORT RESEARCH ON
BIOETHICAL ISSUES, DEVELOPMENT
OF AN EVIDENCE BASE FOR FUTURE
POLICY DECISIONS IN THIS SPACE,
ALSO TO SUPPORT CERTAIN EFFORTS
TO DEVELOP AUGMENT BIOETHICS
RESEARCH CAPACITY.
IF YOU ARE CURRENTLY HOLDING AN
NIH GRANT AND YOU CAN SEE AN
OPPORTUNITY TO DEVELOP THIS,
WITHIN THE SCOPE OF THE GRANT,
PLEASE BY ALL MEANS INQUIRE AND
AS APPROPRIATE APPLY.
YOU CAN GET MORE DETAILS ON THIS
SLIDE HERE AS WELL AS THAT QR
CODE.
DUE DATES STARTING FROM FEBRUARY
OF THIS YEAR, TO APRIL COMING UP
OF THIS YEAR AS WELL.
OKAY.
SO, JUST THIS KIND OF SETUP FOR
OUR SECOND PANEL OF TODAY, WILL
REVOLVE AROUND THIS EXPLOSION OF
STUDIES IN THE LAST FEW YEARS
DEMONSTRATING NEW APPLICATIONS
OF DEEP BRAIN STIMULATIONS TO
TREAT PSYCHIATRIC AND OTHER
BRAIN DISORDERS INCLUDING FOR
EXAMPLE DEPRESSION AND PTSD,
TBI, STROKE RECOVERY, PAIN
MANAGEMENT, AS WELL AS OBSESSIVE
COMPULSIVE DISORDER, EATING
DISORDERS, AS WELL AS MOVEMENT
DISORDERS FOR WHICH DBS WAS
ORIGINALLY DESIGNED.
THIS REMARKABLE INFLECTION POINT
IN THESE THERAPIES I THINK
REFLECTS RAPID ADVANCES IN
CIRCUIT MAPPING, DEVICE DESIGN,
AS WELL AS ARTIFICIAL
INTELLIGENCE APPROACHES TO
INTERPRET BRAIN ACTIVITY DATA,
TRANSLATE THEM INTO BIOMARKERS
THAT CAN BE USED TO INFORM
NEUROMODULATION THERAPIES.
SO, THESE AND RELATED
DEVELOPMENTS RAISE A NUMBER
OFETHICAL ISSUES REGARDING NOT
JUST SAFETY AND PRIVACY.
WE'VE HELD WORKSHOPS ON THIS IN
THE RECENT YEAR.
BUT ALSO ON THE IMPACTS ON THE
PARTICIPANTS AND THEIR FAMILIES
AND CAREGIVERS, AND NOT TO
MENTION SOCIETY MORE BROADLY.
THIS WILL BE A GREAT DISCUSSION
IN OUR SECOND PANEL.
I WANT TO HIGHLIGHT ONE PAPER
THAT REALLY BRINGS THIS TO THE
FOREFRONT.
THIS IS A MULTI-INSTITUTIONAL
STUDY, LED BY DR. HENDERSON AT
STANFORD, WITH IMPACTS ON THE
PARTICIPANTS AND THEIR FAMILIES
PROVIDED BY DR. JOE FINS FROM
CORNELL UNIVERSITY WHO IS HERE
TODAY, AS PART OF HIS
BRAIN-FUNDED NEUROETHICS
PROJECT.
HERE THEY ARE LOOKING AT
PATIENTS WITH MODERATE TO SEVERE
TRAUMATIC BRAIN INJURY, ISSUES
WITH EXECUTIVE FUNCTION, THEY
IDENTIFIED SPECIFIC NUCLEUS OF
THE THALAMUS AS A REGION BASED
ON HYPOTHESIS THAT REDUCED
ACTIVITY HERE IN TERMS OF GIVING
STIMULATION STYING NAILS TO --
SIGNALS TO STRIATUM AND CORTEX
TO LOCATE CENTRAL LATERAL
NUCLEUS AS WELL AS SEGMENTAL
TRACK FOR STIMULATION.
A STUDY THAT INVOLVED FIVE
PARTICIPANTS.
AFTER THREE MONTHS OF
STIMULATION, USING TEST OF
EXECUTIVE FUNCTION, COGNITIVE
FUNCTION, FOUND ON AVERAGE 30%
IMPROVEMENT WITH A RANGE OF 15
TO 52% WHERE 10% IS THRESHOLD.
A PROMISING STUDY SHOWING
STIMULATION IN THIS REGION OF
THE BRAIN, THIS NEXUS, CAN BE
SAFELY APPLIED AND MAY IMPROVE
EXECUTIVE CONTROL IN PATIENTS
WITH MODERATE TO SEVERE TBI
PAVING THE WAY FOR LARGER
CLINICAL TRIALS.
THERE ARE A HOST OF ETHICAL
ISSUES WITH THIS STUDY AND
STUDIES LIKE IT, WE'RE LOOKING
FORWARD TO A PANEL ON THAT.
WE HAVE THE BRAIN BLOG TO STAY
UP TO DATE.
WE PROMISE NOT TO LITTER YOUR
E-MAIL IN-BOXES, A GREAT SOURCE
OF INFORMATION, THE BRAIN
WEBSITE ITSELF, AND THE BEST
SOURCE OF INFORMATION IS OUR
PROGRAM CENTERS, THEY LOOK TO
TALK TO FOLKS IN THE EXTRAMURAL
WORLD ABOUT FUNDING
OPPORTUNITIES.
YOU CAN FIND US AT BRAIN.GOV AND
I'LL STOP THERE.
IF THERE ARE NO QUESTIONS I'LL
HAND THINGS OVER TO THE
CO-MODERATORS FOR THE NEXT
SESSION, DOCTORS CHRISTINE GRADY
AND TERESA CRUZ FROM NICHD.
ANY QUESTIONS OR COMMENTS BEFORE
WE MOVE ON?
>> THANK YOU, JOHN, FOR THAT
UPDATE.
>> I JUST HAVE ONE COMMENT.
I GUESS MAYBE THE ELEPHANT IN
THE ROOM, JOHN PRESENTED WHAT
THE NIH IS DOING.
BUT IN THE PAPER A COUPLE WEEKS
AGO CAME OUT WHAT ELON MUSK IS
DOING.
I THINK THAT RAISED A LOT OF
QUESTIONS.
YOU GUYS HAVE BEEN PURSUING FOR
A WHILE, NICE AT SOME POINT TO
GET THAT MESSAGE OUT, MAYBE
STRONGER.
>> RIGHT.
I MEAN, I THINK THE -- I
CONSIDER NIH AS PART OF A LARGER
ECOSYSTEM WHERE DIFFERENT
MEMBERS OF THE ECOSYSTEM CAN
PLAY DIFFERENT ROLES.
AND I THINK INDUSTRY CERTAINLY
PLAYS -- WILL HAVE TO PLAY A BIG
ROLE IN GETTING THESE DEVICES
THAT LARGELY HAVE BEEN INVENTED
OR AT LEAST THE PREMISE OF THEM
HAS BEEN INVENTED WITH SOME KIND
OF FEDERAL FUNDING.
SO THAT'S A VERY IMPORTANT
PIECE, DISSEMINATION AND
SCALABILITY ARE KEY.
PRIVATE COMPANIES KEEP A LOT OF
INFORMATION AS PROPRIETARY AND
WE WILL DO WHAT WE CAN TO HELP
OUT.
BUT WE REALLY ARE RELYING ON OUR
COLLEAGUES AT THE FDA TO MAKE
SURE THAT THESE STUDIES ARE
BEING CONDUCTED SAFELY, AS
SAFELY AS POSSIBLE, AND
HOPEFULLY THERE CAN BE A
BIDIRECTIONAL EXCHANGE OF
INFORMATION AS THESE
DEVELOPMENTS GO FORWARD.
BUT WE CAN ONLY -- WE AS NIH CAN
ONLY ACT ON INFORMATION THAT WE
HAVE ACCESS TO.
AND WE'RE JUST DOING OUR BEST TO
KEEP THOSE LINES OPEN.
>> ANYBODY ELSE, COMMENTS OR
QUESTIONS FOR JOHN?
I'M GOING TO JUMP IN BEFORE WE
TURN TO OUR PANEL AND INVITE
NITA TO JOIN ME TO WELCOME
EVERYBODY.
WELCOME OUR NEW MEMBERS, WELCOME
OUR GUESTS, WELCOME EVERYONE WHO
IS PARTICIPATING, AND LISTENING.
AND ALSO ADD MY WELCOME TO BOTH
AMY McGUIRE WHO IS NOT HERE
YET AND JEN FRENCH.
THANK YOU FOR JOINING AS MEMBERS
OF OUR GROUPS.
NITA, WOULD YOU LIKE TO SAY
ANYTHING BEFORE I START THE
PANEL?
>> ECHOING YOUR WELCOME
ESPECIALLY TO NEW MEMBERS AS
WELL, WARM CONGRATULATIONS TO
NINA.
THANKS, EVERYBODY FOR JOIN US
TODAY.
REALLY LOOKING FORWARD TO THE
CONVERSATION.
>> WE'LL HAVE A GREAT PANEL TO
START WITH.
I WANT TO INTRODUCE TO YOU IN A
LITTLE MORE FULLY THERESA CRUZ
WHO GENEROUSLY JOINED US TODAY
TO MODERATE ALONG WITH ME, SHE'S
THE DIRECTOR OF NATIONAL CENTER
FOR MEDICAL REHABILITATION
RESEARCH, AT THE NATIONAL
INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOPMENT.
AND SHE'S GOING TO WORK WITH ME
TO MODERATE THIS PANEL AND I'M
GOING TO TURN IT OVER TO THERESA
TO INTRODUCE OUR PANELISTS, SOME
OF WHOM ARE MY FRIENDS, AND I'M
SO GLAD YOU'RE HERE.
>> THANK YOU, CHRISTINE.
LET ME JUST TELL THE GOALS OF
THIS SESSION.
WHAT ARE WE GOING TO BE TALKING
ABOUT TODAY?
WE HAVE THREE GOALS FOR THIS
PANEL.
WE WANT TO HEAR FROM THEM, AND
REACTIONS FROM YOU ALL.
THE CONSIDERATIONS OF UNIQUE, IF
ANY, ETHICAL CHALLENGES THAT
ACCOMPANY PEDIATRIC
NEUROSTIMULATION, THINGS THAT
ARE BEYOND JUST THE
CONSIDERATION WHEN YOU WORK WITH
PEDIATRIC POPULATION.
THE SECOND THING WE'D LIKE TO DO
IS DISCUSS IF THERE ARE ANY
UNIQUE CHALLENGES, HOW WE MIGHT
MEET THEM IN THE FUTURE.
AND ARE THERE ANY POTENTIAL
EMERGING OPPORTUNITIES TO
ADDRESS THOSE QUESTIONS.
THAT KIND OF TIES IN A LITTLE
BIT WITH THE SECOND SESSION
THAT'S GOING TO HAPPEN LATER ON.
SO, WE HAVE FOUR SPEAKERS.
I WANT TO THANK THEM UP TOP FOR
MAKING TIME TO COME TODAY.
I'M GOING TO INTRODUCE THEM EACH
AS THEY GIVE THEIR TALKS,
THEY'VE ABOUT 15 MINUTES TO
PRESENT AND THEN WE WILL TAKE
FIVE MINUTES OF Q&A, AND THEN
THE TEAM HAS LEFT PLENTY OF TIME
FOR MORE GENERAL DISCUSSION
AFTER THE FOUR SPEAKERS.
SO FIRST UP IS MY COLLEAGUE ADAM
HARTMAN.
DR. HARTMAN IS A PROGRAM
DIRECTOR AT THE DIVISION OF
CLINICAL RESEARCH AT NINDS, A
CHILD NEUROLOGIST, AND HAS
BACKGROUND IN EPILEPSY.
HE WAS ASSOCIATE PROFESSOR AT
JOHNS HOPKINS BEFORE COMING TO
NINDS, SCHOOL OF MEDICINE, JOINT
APPOINTMENT IN THE BLOOMBERG
SCHOOL OF PUBLIC HEALTH.
AND HE EARNED HIS BACHELOR'S
DEGREE IN CHEMISTRY AND M.D.
FROM NORTHWESTERN, GO WILDCATS.
I'LL TURN IT OVER TO ADAM.
>> THANK YOU VERY MUCH.
THANK YOU TO THE ORGANIZERS FOR
INVITING ME.
CAN YOU HEAR ME OKAY?
I'M USING A HEAD SET I DON'T
USUALLY USE.
WONDERFUL.
THANKS FOR THE OPPORTUNITY.
I'M ADAM HARTMAN.
I'M A CHILD NEUROLOGIST BUT MORE
GERMANE I'M A PRACTICING
PEDIATRIC NEUROIST AND
SUBSPECIALIZE IN PEDIATRIC
EPILEPSY.
I SEE PATIENTS AT JOHNS HOPKINS
TOMORROW.
THIS IS BASED ON A
CONGLOMERATION OF TWO OR THREE
PATIENTS IN MY CLINIC.
NEXT SLIDE.
MY OVERALL GOAL IS REALLY TO
THINK ABOUT HOW WE PROTECT
CHILDREN THROUGH RESEARCH RATHER
THAN FROM RESEARCH.
YOU'LL SEE HOW SOME OF THESE ARE
PEDIATRIC UNIQUE ISSUES, SOME WE
SHARE WITH ADULTS PARTICULARLY
ADULTS IN A SOMEWHAT DEPENDENT
LIFE POSITION, BUT YOU'LL SEE
HOW SOME OF THESE ARE UNIQUE TO
CHILDREN AS WELL.
NEXT SLIDE PLEASE.
SO LET'S TALK ABOUT THIS
PATIENT, A 7-YEAR-OLD BOY, A
CHRONIC -- I DIDN'T WANT TO
SPECIFY A SPECIFIC NEUROLOGICAL
DISEASE OR DISORDER BUT YOU'LL
HEE HOW HOPEFULLY PEOPLE WITH
SPECIALTIES IN DIFFERENT
NEUROLOGICAL DISEASES WILL SEE
THEIR DISEASE OF INTEREST
REPRESENTED HERE.
HE HAS A CHRONIC PAROSXYSMAL
NEUROLOGIC DISEASE, PERIODS OF
TIME IT FLARES IT.
PRODUCT OF NORMAL PREGNANCY AND
DELIVERY, SIGNS AND SYMPTOMS
AROUND 2 YEARS OF AGE, NO CLEAR
UNDERLYING GENETIC DIAGNOSIS,
PROGNOSTICATION IS NOT 100%
DETERMINED BUT HE ATTENDS A
REGULAR SCHOOL WITH
ACCOMMODATIONS, PAROSXYSMAL
SOMETIMES INTERFERE WITH SCHOOL
AND SOCIAL FUNCTIONING,
COGNITIVELY IMPAIRED BUT CAN
ASCENT TO PROCEDURES AND MAKE
FUND MEDICAL DAILY DECISION,
SEARCH YES/NO DECISIONS AND
BASIC CHOICES WHEN HANDED A FEW
OPTION.
THE FAMILY HAS LIMITED
RESOURCES, CURRENTLY RECEIVING
BENEFITS THROUGH VARIOUS PUBLIC
AID PROGRAMS, THEY HAVE
CHALLENGES WITH TRANSPORTATION,
CHALLENGES WITH SECURITY IN THE
NEIGHBORHOOD WHERE HE LIVES, AND
FOLLOW-UP IN CLINIC IS SOMETIMES
SPORADIC.
SOMETIMES THEY MISS
APPOINTMENTS.
NOT THAT UNCOMMON.
YOU'LL HEAR A DAY OR TWO LATER
WHY THAT HAPPENED, USUALLY
RELATED TO EITHER TRANSPORTATION
ISSUE OR SOMEONE BEING ABLE TO
TAKE TIME OFF FROM WORK.
THE NEXT SLIDE LET'S GET TO KNOW
HIM BETTER.
SO, HE'S BEEN TREATED WITH
MULTIPLE MEDICATION, ALL FAILED
TO TREAT UNDERLYING DISEASE.
RESECTION SURGERY
NOT OPTIONS FOR HIM.
HE DOES RECEIVE PHYSICAL,
OCCUPATIONAL, SPEECH THERAPY AT
SCHOOL.
HIS NEUROLOGIST WAS THINKING YOU
MIGHT BE INTERESTED IN
PARTICIPATING IN A CLINICAL
TRIAL WITH A NEW INVASIVE
NEUROSTIMULATION DEVICE.
THE THING ABOUT THIS DEVICE IT
REQUIRES MANY EARLY FOLLOW-UP
VISITS FOR DEVICE PROGRAMMING,
DEVICE MAINTENANCE, YOU NEED TO
TAKE CARE OF IT AT THE VERY
BEGINNING, AS WELL AS DOING
INFORMATION DOWNLOADS, PART OF
THAT RELATES TO THE PROGRAMMING
AND SOME RELATES TO THE
MAINTENANCE AS WELL.
THE DEVICE HAS BEEN USED IN AN
EXPLORATORY FASHION WITH SOME
SUCCESS IN ADULT FORMS BUT THE
REAL TARGET IS THE PEDIATRIC AGE
GROUP FOR REASONS I'M ABOUT TO
SHARE.
NEXT SLIDE PLEASE.
SO, IN TERMS OF THE CLINICAL
TRIAL DESIGN BECAUSE THIS IS
GOING TO HAVE AN IMPACT ON HOW
WE THINK ABOUT THIS, THERE'S A
BASELINE PERIOD MONITORING TO
SEE HOW OFTEN HE'S HAVING
EVENTS, HOW LONG THEY LAST,
IMPACT THEY ARE HAVING ON HIS
LIFE AND HIS FAMILY'S LIFE
BECAUSE THEY NEED TO MAKE SURE
HE WOULD BE ELIGIBLE FOR THE
ACTUAL TRIAL.
YOU HAVE THE HISTORICAL
INFORMATION BUT THEY WANT TO
START ACTUALLY COLLECTING AFTER
THE NEUROSTIMULATOR HAS BEEN
IMPLANTED, ACTUALLY COLLECTING
ADDITIONAL PHYSIOLOGY-BASED
INFORMATION.
IT'S TWO TREATMENT ARMS.
EITHER RECEIVING STIMULATION OR
NOT.
IT'S GOING TO BE FOUR TREATMENT
BLOCKS, HE WILL BE RANDOMLY
ASSIGNED TO ONE OF A NUMBER OF
PATTERNS, ABAB, ABBA, YOU GET
THE PICTURE, TWO CLOCKS WHERE
HE'S STIMULATION, TWO BLOCKS NOT
RECEIVING STIMULATION, VARYING
DEPENDING WHICH BLOCK HE'S
RANDOMLY ASSIGNED TO.
IT'S A TRIPLE MASKED STUDY.
THE CLINICIAN WHO IS TREATING
HIM AND INVESTIGATOR TEAM
DOESN'T KNOW WHAT HE'S
RECEIVING, HE DOESN'T KNOW, AND
THE PERSON PROGRAMMING THE
DEVICE DOESN'T KNOW WHAT HE'S
RECEIVING EITHER.
SO NOBODY KNOWS WHAT'S GOING ON.
THEY JUST KNOW THEY ARE FLIPPING
A SWITCH.
NEXT SLIDE.
SO SOME ITEMS FOR DISCUSSION, I
DON'T KNOW THAT THERE ARE SOLID
100% ANSWERS BUT THESE ARE THE
SORTS OF THINGS THAT I THINK
ABOUT WHEN SOMETHING LIKE THIS
COMES UP.
WHAT IF THE OPTIMAL TIME FOR
INTERVENTION, THIS IS A
PEDIATRIC-SPECIFIC ISSUE, IS IN
PRE-ADOLESCENCE?
THAT IS LESS THAN IS IT YEARS OF
AGE, BASED ON NATURAL HISTORY
STUDIES SHOWING THAT THE RISK OF
DEATH IS GREATEST AT LESS THAN
12 YEARS OF AGE.
SO, IN THIS PARTICULAR CASE THE
RISK VARIES BY AGE.
WHAT I'M SHOWING IN THIS GRAPH,
TREATMENT IN CLINIC, I THINK OF
RISK AND BENEFIT.
THERE IS A RISK, IT'S NOT HUGE
BUT IT'S MEASURABLE AND KNOWN,
TO SOME DEGREE.
SO THAT RISK SLOWLY DECREASES
OVER TIME.
WHEN WE THINK ABOUT THE
POTENTIAL BENEFIT, THIS IS
DRIVEN BY THAT RISK OF DEATH, IT
REALLY DOES PEAK IN THE EARLIER
YEARS, PRE-ADOLESCENT YEARS, THE
BENEFIT DECREASES OVER TIME.
IT'S NOT ZERO BUT AS YOU CAN SEE
THERE'S VARIABILITY IN THAT RISK
TO BENEFIT RATIO DEPENDING ON
AGE.
IT'S NOT LINEAR EARLIER BETTER,
LATER NOT AS GOOD KIND OF THING
OR CONVERSE.
AND THE REASON I RAISE THIS IS
BECAUSE SOMETIMES THIS QUESTION
IS RAISED IF NEUROMODULATION IS
SUSPECTED TO HAVE A
DISEASE-MODIFYING EFFECT.
THAT IS WHY THIS IS PERTINENT TO
BRAIN INITIATIVE DISCUSSION.
THEY ARE NOT NATURALLY PEDIATRIC
SPECIFIC BUT THEY HIT THE
PEDIATRIC POPULATION DIFFERENTLY
THAN THEY DO OLDER PEOPLE.
AND SO IF HE ACHIEVES RELIEF IN
ONE STUDY BLOCK IS IT ETHICAL TO
MOVE TO THE NEXT ONE?
IT'S TRIPLE MASKED, BUT THE
FAMILY MIGHT SEE THESE EVENTS
REALLY STOP HAPPENING.
WE DON'T KNOW.
IS HE IN A PLACEBO BLOCK OR
TREATMENT BLOCK?
WHAT IF HE DOES NOT LIKE THE
EFFECTS AND WANTS IT REMOVED
WHEN OLDER.
ONCE YOU'VE HAD THAT EFFECT IT'S
NOT GOING AWAY, BECAUSE OF BRAIN
MATURATION, WHAT IF HIS PARENTS
DISAGREE WITH THAT DECISION HE'S
MAKING?
HE HAS SOMEWHAT LIMITED DECISION
MAKING CAPABILITIES.
WHAT'S THE BEST WAY TO HANDLE
HIS ASSENT TO PARTICIPATE?
SOMETHING THAT'S BEEN DISCUSSED
IN THE LITERATURE BUT IS THIS
COMMUNICATING THAT VARIABLE
RISK/BENEFIT RATIO IS DIFFERENT
THAN MORE STRAIGHTFORWARD, YOU
KNOW, IF BOTH LINES WERE LINEAR
OR HAD A FIXED SLOPE.
AND THEN THIS COMES UP, THE LAST
ONE, A LOT.
VERY REAL WORLD.
I FACED THIS BEFORE IN MY CLINIC
MULTIPLE TYPES.
SO FAMILY'S LOGISTICS CHALLENGES
AFFECT WHETHER HE SHOULD BE
OFFERED THE OPPORTUNITY IN THE
STUDY GIVEN THERE'S HIGH DEMAND
FOR PARTICIPATION, PARTICULARLY
EARLY IN THE STUDY.
AND I THINK AS WE GO TO THE NEXT
SLIDE, I BELIEVE THAT WAS IT.
I WANTED TO THANK EVERYONE FOR
INVITING MY PARTICIPATION AND
HOPEFULLY WE CAN HAVE A RICH
DISCUSSION ABOUT SOME OF THESE
ISSUES.
>> THAT WAS GREAT SETUP.
DO ANY OF THE NEWG MEMBERS HAVE
QUESTIONS FOR ADAM CLARIFYING
THE SITUATION OR MORE ABOUT THE
DISCUSSION TOPICS?
YES, CHRISTINE?
>> A QUICK QUESTION, ADAM, MAYBE
YOU SAID IT.
HOW LONG ARE THE PERIODS OF
STIMULATION AND THEN NO
STIMULATION?
>> GOOD QUESTION.
I DIDN'T SAY IT.
WHY DON'T WE SAY THREE MONTHS.
>> THREE MONTHS ON, THREE MONTHS
OFF.
>> YEAH.
>> A PATTERN.
>> YEAH, A YEAR-LONG STUDY.
>> THANK YOU.
>> SAMEER?
>> WHAT WOULD YOU IDENTIFY AS
THE PEDIATRIC-SPECIFIC
COMPONENTS?
THE ONE OBVIOUSLY I THINK IS
THAT THERE'S A DEVELOPING BRAIN,
AND SO THE KIND OF CURVE YOU
SHOWED IN TERMS OF RISK AND
BENEFIT OVER TIME WILL BE A BIT
SPECIFIC TO THE DEVELOPING BRAIN
VERSUS THE ADULT BRAIN, OTHERS
WHETHER THE PERSON IS ABLE TO
CONSENT VERSUS ASSENT, TRUE, BUT
THAT ALSO HAPPENS IN IN ADULTS
WHO ARE DEPENDENT.
THE FIRST IS CRITICAL.
ARE THERE OTHERS YOU CONSIDER
PEDIATRIC SPECIFIC?
>> YEAH, GOOD QUESTION.
THE FIRST IS THE MOST PEDIATRIC
SPECIFIC ONE.
YOU COULD SAY THAT THIS HAPPENS
IN ADULTS TOO BUT THIS IS THE
ONE THAT COMES UP THE MOST IN
DISCUSSION.
I THINK THE OTHER COMPONENT
AGAIN IT'S NOT PEDIATRIC
SPECIFIC BUT I THINK IT HITS THE
PEDIATRIC POPULATION A LITTLE
BIT DIFFERENTLY IS THE LIFE
CIRCUMSTANCES AND SOME OF THE
SOCIAL DETERMINANTS OF HEALTH.
AGAIN, THOSE AREN'T NECESSARILY
UNIQUE BUT I THINK TO -- TO
PEDIATRIC.
BUT THE WAY THEY IMPACT THE
PEDIATRIC POPULATION IS A LITTLE
BIT DIFFERENT THAN IT IMPACTS
ADULTS.
AND FINALLY I THINK WE HAVE THIS
ISSUE OF EXPLANTATION, WHICH IS
NOT UNIQUE TO PEDIATRICS BUT I
THINK THAT HIS LIMITED
DECISION-MAKING ABILITY AND THE
TIME FRAME OVER WHICH -- WE'RE
EXPECTING THIS PERSON ORDINARILY
LIVING, YOU KNOW, 70, 80 YEARS,
AND SO I THINK THAT THE TIME
SCALE, I THINK THINGS GET
WEIGHTED A LITTLE BIT
DIFFERENTLY.
>> I WAS WONDERING WILL
LONG-TERM CIRCUIT EFFECTS.
IS IT REINFORCEMENT OF CIRCUITS?
IS IT NEW NEUROGENESIS,
SYNAPTOGENESIS, IS THERE
POTENTIAL ENHANCEMENT AS OPPOSED
TO MAINTENANCE ASSOCIATED WITH
THE STIMULATION?
>> GREAT QUESTION.
WE TRIED TO MAKE THIS SOMEWHAT
DISEASE AGNOSTIC SO I THINK ANY
OF THOSE WOULD BE FAIR GAME FOR
DISCUSSION.
>> OKAY.
SEEING NO OTHER HANDS, GOING
ONCE, GOING TWICE.
ALL RIGHT.
LET'S MOVE TO OUR SECOND
SPEAKER.
NEXT UP WE HAVE DR. MARTY
MORRELL, SHE'S A CLINICAL
PROFESSOR OF NEUROLOGY AT
STANFORD UNIVERSITY, GRADUATE OF
THE STANFORD MEDICAL SCHOOL,
RESIDENCY TRAINING IN NEUROLOGY
AT UNIVERSITY OF PENNSYLVANIA,
AS WELL AS FELLOWSHIP TRAINING
IN GENE EPILEPS, ACTIVE IN
BRINGING DEVICES TO PEOPLE WITH
EPILEPSY, AND CHIEF MEDICAL
OFFICER SINCE 2004 WITH A
COMPANY THAT DEVELOPED
RESPONSIVE NEUROSTIMULATOR FOR
TREATMENT OF MEDICALLY
UNCONTROLLED PARTIAL SEIZURES.
>> THANK YOU SO MUCH.
AND I'LL JUST CONFIRM YOU SEE MY
SLIDE.
>> WE DON'T SEE IT YET.
>> YOU DON'T SEE IT YET?
OKAY.
SO WHAT I WILL NEED TO DO IS TO
SHARE.
HERE WE GO.
NOW YOU SHOULD BE ABLE TO SEE
IT.
EXCUSE ME.
IT IS UPLOADING.
I'LL BEGIN BY SAYING MY TITLE IS
DELIVERING NEW NEURAL
STIMULATION THERAPIES TO
CHILDREN, I'M NOT AT ETHICIST
BUT WILL ATTEMPT TO DISCUSS
ETHICAL CONSIDERATIONS, ALSO
PRAGMATIC.
AND I'LL ALSO BEGIN WHILE
THERE'S SOME PROBLEMS WITH MY
SLIDES LOADING, TO PROVIDE SOME
CONTEXT.
SO, I DO HAVE CONFLICTS OF
INTEREST.
I'M CHIEF MEDICAL CENTER OF
NEURAL PACE, A COMPANY THAT
DEVELOPED AND BRINGS TO PATIENTS
RESPONSIVE NEUROSTIMULATION FOR
EPILEPSY.
I ALSO AM AN EMPLOYEE, AND
OFFICER OF THE COMPANY.
IN ADDITION I'M A PRINCIPAL
INVESTIGATOR OF AN NIH UH3 GRANT
IN EPILEPSY, AND LIKE ADAM I'M A
PHYSICIAN WHO IS ACTIVELY
TREATING PERSONS WITH EPILEPSY.
AND I APOLOGIZE FOR THIS SNAFU.
I DON'T KNOW WHY IT IS NOT
WORKING.
>> WOULD IT BE HELPFUL IF YOU
SHARED YOUR SLIDES WITH ONE OF
THE ORGANIZERS AND WE CAN TRY TO
PROJECT IT?
>> YEAH, WHY DON'T WE DO THAT.
>> I'M GOING TO ASK NINA, WHO IS
THE BEST PERSON FOR MARTY TO
SEND HER SLIDES TO?
>> DR. MORRELL, THE BEST PERSON
TO E-MAIL THEM IS REBECCA, I
WILL DROP HER E-MAIL IN THE
CHAT.
>> OKAY.
VERY GOOD.
>> WHILE THAT'S HAPPENING FEEL
FREE TO CONTINUE TO TALK YOUR
WAY THROUGH.
>> WELL, I MAY BE ABLE TO DO
THIS A DIFFERENT WAY.
SO, I AM IT IS PUTTING ME INTO A
DIFFERENT -- I'M JUST GOING TO
ACTUALLY PROBABLY -- LET'S SEE
IF I CAN PRESENT.
>> MAYBE WHILE YOU SEND THE
SLIDES TO REBECCA SHALL WE SKIP
TO THE NEXT SPEAKER AND HAVE YOU
COME BACK?
DOES THAT WORK FOR YOU?
>> THAT WOULD WORK BETTER.
THANK YOU.
>> ASSUMING THAT THE NEXT
SPEAKER IS READY.
SORRY, DIDN'T MEAN TO CAUSE A
CASCADE HERE.
>> I'M THE NEXT SPEAKER AND I'M
READY.
>> OKAY, GREAT.
>> I JUST FOUND MY VIDEO BUTTON.
THANKS VERY MUCH.
>> THANKS FOR BEING
ACCOMMODATING, BEN.
NEXT SPEAKER IS DR. BEN
WILFOND, INVESTIGATOR AT CENTER
FOR PEDIATRIC AND BIOETHICS AND
PULMONARY CARE, SEATTLE
CHILDREN'S HOSPITAL, PROFESSOR
IN PULMONARY AND SLEEP MEDICINE,
PEDIATRICS, UNIVERSITY OF
WASHINGTON SCHOOL OF MEDICINE.
AND I WILL TURN IT OVER TO HIM.
THANK YOU.
>> I WILL SEE IF I CAN
SUCCESSFULLY SHARE MY SLIDES.
LET ME SEE IF THIS WORKS.
OKAY.
CAN YOU SEE THOSE?
>> YES.
THEY ARE NOT IN PRESENTATION
MODE.
>> I'M HITTING THAT BUTTON NOW.
>> PERFECT.
>> I'M ON THE WRONG SLIDE.
OKAY.
SO, FIRST OF ALL, I'M READY TO
GO.
FIRST OF ALL, THANK YOU FOR
HAVING ME HERE.
I'M NOT A NEUROLOGIST, I'M A
PEDIATRIC PULMONOLOGIST.
MY FOCUS IS ON INFANTS WITH
CHRONIC LUNG DISEASE AND
PREMATURITY, SPECIFICALLY MEANS
I'M REALLY USED TO DEALING WITH
SMALL BABIES.
FOR ME, I WOULD DESCRIBE IT AS
THE PEDIATRICS IS INHERENT IN
EVERYTHING I DO.
FOR ME, LESS RELEVANT TO ADULTS
BECAUSE THIS IS KIND OF MY BREAD
AND BUTTER.
WHEN NINA FIRST ASKED ME TO GIVE
THIS PRESENTATION, I HAVE TO
ACKNOWLEDGE I WAS QUITE
INTIMIDATED BECAUSE I DON'T
NORMALLY THINK ABOUT ISSUES OF
NEUROLOGY BUT ALSO TOPIC WAS
BROAD, REMINDED ME OF A FRESHMAN
PHILOSOPHY EXAM THAT WE HAD ONE
QUESTION, WHICH WAS DEFINE THE
UNIVERSE AND GIVE TWO EXAMPLES.
AND SO I ASKED NINA, I WISH WE
COULD HAVE A CASE TO FOCUS ON.
I APPRECIATE, I'M GLAD ADAM
PRESENTED THAT CASE BECAUSE MY
INTENTION IS TO TRY TO ADDRESS
MANY OF THE ISSUES THAT ADAM
IDENTIFIED AS WELL AS TALK ABOUT
A FEW OTHERS.
BECAUSE I ONLY HAVE 15 MINUTES
I'M IN GENERAL TALKING ABOUT
THIS AT A FAIRLY HIGH LEVEL.
THERE'S MUCH ROOM FOR FURTHER
CONVERSATION AS WELL.
I'M ACTUALLY GOING TO BEGIN WITH
A SLIDE THAT'S BASED UPON A
PAPER THAT CHRISTINE GRADY WAS A
CO-AUTHOR ON, FROM ALMOST 25
YEARS AGO, THAT HAS BEEN THE
FRAMEWORK I'VE USED SINCE THEN
FOR THINKING ABOUT ANY ETHICAL
ISSUE WHICH IS TO IDENTIFY THESE
EIGHT COMPONENTS, BENCHMARKS,
FOR THINKING ABOUT ETHICAL
CLINICAL RESEARCH, AND YOU'LL
SEE MY COMMENTS ADDRESS MANY OF
THESE TOPICS.
THIS FRAMEWORK DOES NOT SOLVE
THE PROBLEM BUT HELPS IDENTIFY
WHERE THE ISSUE IS AND SO YOU'LL
SEE ME COMMENTING ON THESE
BENCHMARKS DURING MY TALK.
THE OTHER THING I'M GOING TO
BRING FOR ORIENTATION IS ANOTHER
SPECIFIC FOR PEDIATRIC RESEARCH
THAT WAS ACTUALLY FIRST ABOUT
TEN YEARS AGO BY SKIP NELSON AND
RALPH KLEIN, BASED UPON -- ROTH
CLINE, IT PUTS IT IN A
DIGESTIBLE STRUCTURE, A CRITICAL
ISSUE, ONLY TO ENROLL CHILDREN
WHEN SCIENTIFICALLY IMPORTANT.
ADAM TALKED ABOUT THE POTENTIAL
ISSUE OF THE DEVELOPING BRAIN.
FOR ME THAT'S NOT A PROBLEM.
THAT'S THE REASON FOR DOING
THIS.
AND THE PARTICULAR IMPORTANT
REASON FOR WHY WE WANT TO THINK
HOW TO DO IT IN YOUNG CHILDREN.
ANOTHER PART OF THIS FRAMEWORK
IS THINKING ABOUT RISKS AND
CONCEPTUALLY THE MAIN IDEA ALL
THINGS BEING EQUAL WE WANT TO
HAVE LOWER RISKS THAN WE MIGHT
BE WILLING TO ACCEPT IN ADULTS.
AND IDEALLY WE WANT TO ENSURE
THAT THERE'S SOME OPPORTUNITY
FOR DIRECT BENEFIT WHEN
POSSIBLE.
PARTICULARLY THINGS BEING DONE
FOR THERAPEUTIC INTENT.
SOME RESEARCH DOES NOT HAVE A
THERAPEUTIC INTENT, AND THERE
ARE NO DIRECT BENEFITS, BUT AT
LEAST WE WANT TO MAKE SURE
PEOPLE ARE NOT DISADVANTAGED BY
PARTICIPATING IN THE RESEARCH,
NOT EXPOSED TO EITHER EXCESSES
OF RISK OR OTHERWISE LIMIT
OTHERWISE AVAILABLE CARE.
THE FOURTH ISSUE IS ASSENT WHICH
WE'LL TALK ABOUT, ADAM SUGGESTED
THIS WAS MORE COVERED, I DON'T
KNOW HOW YOU THINK IT'S BEING
COVERED SO I'M GOING TO SPEND
MORE TIME TALKING ABOUT ASSENT
THAN OTHER ISSUES.
THE FINAL ISSUE IS NOT IN THE
ROTH-CLINE-NELSON FRAMEWORK BUT
I ADDED THE NOTION OF COMMUNITY
ENGAGEMENT AND PUBLIC REVIEW.
YOU'LL HEAR ABOUT WHAT IN
ANOTHER PRESENTATION, TALKING
ABOUT DATA FROM COMMUNITY
ENGAGEMENT, I THINK PARTICULARLY
IMPORTANT AND THIS MEETING
ITSELF IS AN EXAMPLE OF THE TYPE
OF ENGAGEMENT THAT'S NECESSARY.
SO I'M GOING TO TALK ABOUT FOUR
ISSUES BRIEFLY.
COMMENTS ABOUT
PLACEBO-CONTROLLED TRIALS,
POST-TRIAL OBLIGATIONS, AND WITH
PERMISSION AND ASSENT.
I WANT TO TAKE ADAM'S QUESTION,
TRY TO GIVE SHORT SIMPLE ANSWERS
THAT CLEARLY NEED MORE NUANCE
BUT THIS IS MY SHORT VERSION,
LIKE MY PHILOSOPHY EXAM WHERE
YOU HAD TO FIND THE UNIVERSE AND
GIVE TWO EXAMPLES.
SELECTION OF CHILDREN, ONE OF
THE BIG ISSUES THAT COMES UP FOR
NEW DEVICES PARTICULARLY, NEW
MEDICATIONS, IS NOTION THAT WE
TYPICALLY DO THINGS IN ADULTS
BEFORE CHILDREN.
THIS BECOMES CHALLENGING WHEN
THE DISEASE IS EITHER DIFFERENT
IN CHILDREN OR HAS DIFFERENT
IMPLICATIONS.
AND I THINK THE CONCEPTS OF THE
FRAMEWORK OF SCIENTIFIC VALIDITY
AND SOCIAL VALUE DRIVE TOWARDS
EARLIER INCLUSION OF CHILDREN TO
ANSWER THOSE QUESTIONS
SCIENTIFICALLY NECESSARY AND AS
IMPORTANTLY ARE CRITICALLY
SOCIALLY IMPORTANT FOR THOSE
CHILDREN THEMSELVES.
I THINK IT'S GOOD TO INCLUDE
CHILDREN.
SECONDLY, THE QUESTION ABOUT THE
AGE OF THE CHILDREN.
THERE'S ALL SORTS, PARTICULARLY
BECAUSE OF NOTION OF ASSENT FOR
AGE DEESCALATION.
START IN ADULTS, GO
17-YEAR-OLDS, THEN 15-YEAR-OLD,
THEN 12-YEAR-OLDS, AND WORK YOUR
WAY DOWN.
THIS IS A COMMON PRACTICE.
AGAIN, AS A PULMONOLOGIST TAKING
CARE OF BABIES IT'S FRUSTRATING
WHEN I HAVE TO WAIT A LONG TIME
FOR THINGS TO COME UP AND
CLEARLY THERE'S VALUE TO
THINKING ABOUT YOUNG CHILDREN
MORE PARTICULARLY WHEN THERE'S
SCIENTIFIC REASONS AS WELL AS
RISK/BENEFIT RATIO MAY BE
DIFFERENT IN THESE YOUNGER
CHILDREN.
I WANT TO MAKE MORE COMMENTS
WILL INCLUDE OF CHILDREN WITH
FUNDED RESOURCES AND SAY THAT A
VARIETY OF REASONS THIS IS TO ME
UNAMBIGUOUS, HOW TO DO BETTER,
FOR MANY REASONS.
IN PART THESE CHILDREN ARE NOT
RESPONSIBLE FOR THEIR SOCIAL
CIRCUMSTANCES.
PARTICULARLY WE'RE THINKING
ABOUT THE TYPES OF
INTERVENTIONS, MAKING
ACCOMMODATIONS TO INCLUDE THEM
IN TRIALS IN THE SAME WAY,
ACCOMMODATIONS TO INCLUDES
CHILDREN IN SCHOOL WHO OTHERWISE
HAVE ISSUES, IS CRITICALLY
IMPORTANT.
PARTICULARLY, ADAM, YOU PROBABLY
HAVE MAYBE MORE RESOURCES THAN
OTHERS MIGHT HAVE BUT THE NOTION
OF ASKING WHAT CAN WE DO TO
SUPPORT THOSE FAMILIES, TO HELP
THEM BE ABLE TO PARTICIPATE IN
TRIALS IS WHAT WE SHOULD BE
DOING RATHER THAN EXCLUDING
THEM, FIGURE OUT HOW TO MEET
THEM WHERE THEY ARE.
QUICKLY REGARDING RISK/BENEFIT,
THE ISSUE HERE, PRIMARY
OBLIGATION IS TO MINIMIZE RISK,
AVOIDING MAKING SURE THEY ARE
WORSE OFF AS THE
ROTH-CLINE-NELSON PAPER
DESCRIBED.
YOU'RE GOING TO BE -- EVERY
INDIVIDUAL IS RECEIVING BOTH
PLACEBO AS WELL AS STIMULATION.
I DON'T THINK IT'S A PROBLEM
THAT DURING THIS ONE YEAR SOME
MONTHS ARE MAYBE BETTER, IF THIS
IS EFFECTIVE, SOME MONTHS MAY BE
BETTER THAN OTHERS.
BUT IN GENERAL, PEOPLE MAY BE
WORSE OFF BY PARTICIPATING IN
THE TRIAL, THERE'S PROBABLY
IMPORTANT SCIENTIFIC QUESTIONS
THAT WILL BE ANSWERED BY
CONTINUING THE TRIAL FOR THE
FULL PERIOD OF TIME AND I THINK
THE OTHER POINT I WANT TO BRING
UP IS THAT IF THERE ARE
QUESTIONS ABOUT THAT, THAT'S
WHAT WE TYPICALLY HAVE A DATA
MONITORING COMMITTEE FOR, TO
PLAY A ROLE IN THOSE DECISIONS.
I THINK THERE THE ISSUE IS
ENSURING THAT THE DATA
MONITORING COMMITTEE HAVE THE
SOPHISTICATION AND EXPERIENCE TO
MAKE THOSE DECISIONS IN A
NUANCED WAY, SIMPLY HAVING DATA
MONITORING COMMITTEE DOESN'T
SOLVE THE PROBLEM, THEY HAVE TO
HAVE CAPACITY TO MAKE
INDEPENDENT DECISION WITH NUANCE
AND ADVISE SPONSORS ABOUT THE
WAY TO.
POST TRIBAL OBLIGATIONS, FIRST
QUESTION CAN OLDER CHILD REQUEST
DISCONTINUATION OF DEVICE, AND I
THINK RESPECT REQUIRES
CONSIDERATION, OLDER CHILDREN
MIGHT DECIDE I DON'T LIKE WHAT
THIS IS DOING OR WHAT IT'S DONE,
I WANT THIS OUT.
I THINK IT'S SOMETHING THAT TO
ME AT A CONVERSATION LEVEL OF
COURSE I WANT TO FIGURE OUT HOW
TO ACCOMMODATE IF IT WAS
APPROPRIATELY FEASIBLE TO DO.
ADAM ASKED WHAT IS THE PROBLEM
WITH THINGS AREN'T REVERSIBLE,
SO MY COMMENT MAY BE MISPLACED,
BUT I THINK THE FACT THAT
THERE'S IRREVERSIBILITY IN
GENERAL HAPPENS ALL THE TIME I
DESCRIBED MARTY McFLY FROM
BACK TO THE FUTURE, YOU CAN GO
BACK AND CHANGE YOUR PATH BUT
NORMALLY ALL OF US HAVE
IRREVERSIBLE PASTS AND ALL
DECISIONS MADE FOR US WE LIVE
WITH MOST OF OUR LIVES, TRUE FOR
THIS AS MUCH AS ANYTHING ELSE.
BUT I WANT TO BRING UP ONE FINAL
ISSUE THAT ADAM DID NOT RAISE
BUT NINA HAD MENTIONED,
IMPORTANT, REGARDING OBLIGATIONS
TO PROVIDE CLOSE CARE AFTER THE
STUDY.
I DO THINK IN THE CONTEXT OF
IMPLANTED DEVICES I THINK IT
DOES REQUIRE GREATER OBLIGATIONS
TO THINK THROUGH WHAT HAPPENS
AFTER THE PERSON IS OFF THE
TRIAL, WHAT OBLIGATION IS THERE
TO MAINTAIN THE DEVICE, TO
UTILIZE THE DEVICE, I THINK
THAT'S ONE THAT ALTHOUGH I
HAVEN'T THOUGHT A LOT ABOUT IT,
MY INCLINATION WOULD BE TO THINK
THOUGHTFULLY ABOUT MAKING
PROVISIONS FOR DOING THAT.
IT WOULD REQUIRE CONSIDERATION
OF PLANNING FOR ONGOING
RESOURCES BUT THIS IS A UNIQUE
ASPECT OF THESE TYPES OF TRIALS
THAT STRIKES ME AS BEING
IMPORTANT TO THINK ABOUT.
I WANT TO END BY MAKING A FEW
MORE COMMENTS, THIS IS THE WAY
ADAM DESCRIBED IT.
THE BEST WAY TO HANDLE ASSENT,
GENERAL THOUGHTS ABOUT ASSENT.
I THINK IT'S IMPORTANT TO THINK
ABOUT IN CHILDREN WE DON'T TALK
ABOUT CONSENT, WE TALK ABOUT ON
ONE HAND PARENTAL PERMISSION,
WHAT PARENTS DO, WHICH IS A
DIFFERENT ACTIVITY.
IT MEANS THE PARENTS HAVE TO
THINK ABOUT THEIR CHILDREN'S
INTEREST AND IT ALSO MEANS THE
PROVIDERS AND RESEARCHERS HAVE A
GREATER ROLE IN DECISION MAKING
THAN THEY OTHERWISE WOULD IF IT
WAS ADULTS.
THE QUESTION IS WHAT DOES ASSENT
MEAN?
AND SO ASSENT IS ACTUALLY NOT --
IT'S ACTUALLY -- IT'S NOW LIKE
40 YEARS OLD BUT WAS A CONCEPT
ARGUED PROFOUNDLY BY BARTHOLOMEW
IN 1980s, FINALLY ADOPTING BY
AMERICAN ACADEMY OF PEDIATRICS
IN 1995.
BUT IT'S A CONCEPT THAT TALKS
ABOUT HAVING PEOPLE THINK ABOUT
DEVELOPMENTALLY, ABOUT WHAT IT'S
APPROPRIATE AWARENESS OF
CONDITION, ENSURING EXPECTATIONS
FOR TESTING TREATMENTS, EFFORTS
TO TRY TO UNDERSTAND, ASSESS
UNDERSTANDING AND VOLUNTARINESS,
AND WHEN APPROPRIATE SOLICITING
PREFERENCES.
I POINT I WANT TO BRING UP
ASSENT IS NOT SIMPLY ABOUT YES
OR NO BUT OTHER DIMENSIONS AS
WELL.
SO CONCEPTUALLY THE NOTION OF
ENGAGING EVEN YOUNG CHILDREN 5
YEARS OLD, 4, 3, IS INCREDIBLY
IMPORTANT AS YOU ENGAGE.
BARTHOLOMEW WAS INTERESTED IN
THINKING ABOUT CHILDREN WHO THEY
ARE AND WHAT THEY ARE AT AND
TREAT THEM APPROPRIATELY
DEVELOPMENTALLY.
WE CAN THINK OF A WAY TO
ENGAGING CHILDREN AT ALL AGES,
AND A PARTICULAR CHILD AND
CHILDREN IN GENERAL AND
WELL-BEING.
THERE'S DIFFERENT WAYS PARENTS
OFTEN ENGAGE OUR CHILDREN.
THEY MIGHT THINK ABOUT ASSENT
DIFFERENTLY.
I WANT TO GIVE EXAMPLES OUTSIDE
RESEARCH PARENTS HAVE TO MAKE
DECISIONS ABOUT SPORTS
ACTIVITIES, PARTICIPATION IN
RELIGIOUS ACTIVITIES, VISITING
RELATIVES, HELPING NEIGHBORS.
THERE'S ENGAGEMENT WITH CHILDREN
BY THEIR PARENTS ABOUT THESE
ACTIVITIES IS THE POINT.
THAT USUALLY RESULTS IN SOME
DECISION FOR THAT CHILD TO DO OR
NOT, THE CHILD IS INVOLVED IN
THE DECISION SOMETIMES.
THEY MAY PLAY A FAIRLY HEAVY
HAND, YES, WE'RE GOING SEE
GRANDMA TODAY EVEN THOUGH YOU
DON'T WANT TO OR NO, IF YOU
DON'T WANT TO PLAY SOCCER THAT'S
OKAY.
SO THERE'S A LOT OF WAYS THIS
GETS PLAYED OUT.
THAT'S RELEVANT AS WE THINK
ABOUT RESEARCH.
THIS IS MY LAST -- TWO MORE
SLIDES AND I'LL BE DONE.
I THINK WE SHOULD BE THINKING
ABOUT ASSENT FOR RESEARCH AS THE
WAY WE DO IT AS A OTHER LIFE
DECISIONS AND NOT CONSENT FOR
ADULTS IN CLINICAL RESEARCH.
SOME PARENTAL PRESSURE MAY BE
APPROPRIATE.
THERE'S A NUMBER OF SCHOLARS
THAT HAVE WRITTEN ABOUT THIS
TOPIC.
SOME OF THESE PEOPLE HAVE
IDENTIFIED THE WAY WHICH ASSENT
IS INCORPORATED INTO REGULATIONS
DOESN'T MAKE SENSE FROM A
CLINICAL PERSPECTIVE.
SO THE NOTION OF WAIVING ASSENT
IS NOT CONSIST WENT STANDARD FOR
CLINICAL CARE.
WE TYPICALLY GET ASSENT FOR
DOING THINGS CLINICALLY FOR
KIDS.
MORE IMPORTANTLY, REQUIRING
ASSENT FOR NON-BENEFICIAL
RESEARCH, I.E. THEY MUST SAY
YES, IS ALSO NOT CONSISTENT WITH
ACCEPTING DISCRETION FOR
INVOLVING CHILDREN.
THE LAST SLIDE HAS TO DO WITH
AGE.
THIS IS FROM 20 YEARS AGO, THERE
WAS A SERIES OF PAPERS IN THE
AMERICAN JOURNAL OF BIOETHICS
THAT TALKED ABOUT THE QUESTION
OF AGE, AND CONSENT AND ASSENT.
I WANT TO POINT OUT FROM THE
FOUR AUTHORS THE WAY IN WHICH
THEY USE DIFFERENT WORDS TO TALK
ABOUT HOW WE SHOULD BE THINKING
AND HOW WE SHOULD BE RESPECTING
CHILDREN, AND THEY TALK ABOUT
THE NOTION OF DISSENT, DISTRESS,
ASSENT, INVOLVEMENT.
THE ONE I FOUND MOST VALUABLE
WAS THE MANUSCRIPT BY JOFFE,
NOTION OF INVOLVEMENT AND
AGREEMENT AS BEING RELEVANT BUT
THE KEY HERE IS THAT EVEN IN HIS
NOTION OF AGREEMENT PROBABLY
DOESN'T BEGIN FOR AGE 11 OR 12
BUT PRIOR TO THAT MORE ABOUT
INVOLVEMENT.
I'M GOING TO END WITH TWO FINAL
CONSIDERATIONS.
I THINK ALL OF THESE ISSUES
REALLY THAT WE'RE THINKING OF AS
REGARDING THIS FIELD OF
NEUROSTIMULATION IN CHILDREN
REQUIRES ONGOING COMMUNITY
ENGAGEMENT OF PARENTS AND
CHILDREN THINKING ABOUT THESE
ISSUES AND IDEALLY EVEN DURING
THE TRIAL MAKING SURE WE INCLUDE
EVALUATION OF FAMILY EXPERIENCE
DURING THE TRIALS, AS WE HAVE
MORE SCIENTIFIC KNOWLEDGE WE CAN
ALSO BE ACCUMULATING ETHICAL
KNOWLEDGE BASED UPON
UNDERSTANDING WHAT'S WORKING,
WHAT'S NOT WORKING, AND CONTINUE
TO WORK TO REFINE THAT GOING
FORWARD.
I'LL STOP SHARING.
HOPEFULLY I'VE SUCCEEDED, NINA,
IN THE TASK YOU'VE ASSIGNED ME.
>> I'LL SPEAK FOR NINA AND SAY
YES.
THAT WAS GREAT.
WE HAVE TIME FOR ONE OR TWO
QUICK CLARIFYING QUESTIONS.
YES, CHRISTINE?
>> THANK YOU, BEN.
I WANTED TO ASK ABOUT YOUR
REFERENCE TO COMMUNITY
ENGAGEMENT.
DO YOU THINK THERE'S SOMETHING
DIFFERENT ABOUT NEUROSTIMULATION
RESEARCH THAT REQUIRES COMMUNITY
ENGAGEMENT, THAT'S ONE PART OF
THE QUESTION.
SECOND WHEN YOU'RE THINKING
ABOUT COMMUNITY ENGAGEMENT, ARE
YOU THINKING ABOUT FAMILIES OF
CHILDREN WHO MIGHT BE
PROSPECTIVE PARTICIPANTS OR
SOMETHING BROADER THAN THAT?
>> THANK YOU.
FIRST OF ALL, I THINK COMMUNITY
ENGAGEMENT FRANKLY IS LIKE THE
ESSENCE OF ETHICAL RESEARCH.
AND SO THIS IS NOT UNIQUE..
I LEARNED THIS FROM YOU SO I'M
CHANNELED YOUR WISDOM.
THIS IS THE FUNDAMENTAL ISSUE,
ALL THE TIME.
DOESN'T SOLVE EVERYTHING BUT
IT'S A FOUNDATION FOR HOW WE
THINK ABOUT THIS.
I ALSO THINK THAT COMMUNITY
ENGAGEMENT SHOULD BE THOUGHT OF
BROADLY.
YES, OF COURSE, INCLUDES THE
FAMILIES, POTENTIALLY THE
CHILDREN DEPENDING ON
CIRCUMSTANCES WHO WILL BE
PARTICIPANTS IN THESE TRIALS.
WE OUGHT TO THINK BROADLY WHAT
THE COMMUNITY IS, COMMUNITY
INCLUDES RESEARCHERS,
COORDINATORS, COMPANIES DOING
THIS WORK.
WE'RE ALL IN THIS TOGETHER.
SO I THINK IT'S IMPORTANT TO
HEAR FROM EVERYBODY'S
PERSPECTIVE SO FRANKLY I'M
EXCITED TO HEAR BECAUSE
PERSPECTIVE OF SOMEBODY WHO
WORKS FOR A COMPANY TRYING TO
BRING THINGS TO MARKET,
CRITICALLY IMPORTANT TO THINK
ABOUT HOW WE DO THIS WELL.
>> I SEE JEN'S HAND.
>> THANK YOU.
YEAH, BEN, GREAT PRESENTATION.
I'M GOING TO DOVETAIL OFF THE
PREVIOUS QUESTION ABOUT
COMMUNITY ENGAGEMENT.
I'M WONDERING A LOT OF TIMES WE
THINK OF COMMUNITY ENGAGEMENT
ONCE THE TRIAL HAS STARTED
RATHER THAN COMMUNITY ENGAGEMENT
EVEN PRIOR.
AND WONDERING ABOUT YOUR
PERSPECTIVES OF ASSENT AND
CONSENT PARTICULARLY WHEN A LOT
OF NEUROMODULATION TRIALS ARE
WROUGHT WITH TECHNICAL LANGUAGE
THAT MAKES IT DIFFICULT TO
UNDERSTAND.
ONE OTHER QUESTION ALONG WITH
THAT THINKING -- HAVE YOU
ENCOUNTERED REAL COMMUNITY
ENGAGEMENT OF THE BURDEN OF
UNDERSTANDING OF PARENTS OR
CAREGIVER TO INVOLVEMENT IN
TRIALS?
>> YEAH, WELL, THANK YOU FOR
THOSE QUESTIONS.
I THINK -- I'LL TRY TO ANSWER
QUICKLY.
>> I OPENED A CAN OF WORMS,
DIDN'T I?
>> IT'S SOMETHING I COULD TALK
ABOUT FOREVER.
I WANT TO BE RESPECTFUL OF TIME.
COMMUNITY ENGAGEMENT CAN ALWAYS
OCCUR BEFORE AS WELL AS DURING.
WHAT IS THE BEST WAY TO DO THESE
TRIALS CAN BE A VALUABLE THING.
AND I ALSO THINK YOUR POINT
ABOUT THE BURDEN AND IMPACT ON
FAMILIES IS CRITICAL, THAT CAN
BE DONE AHEAD OF TIME TO LEARN
WHAT CAN REDUCE THAT BURDEN.
FOR EXAMPLE, MY OTHER AREA AS A
PULMONOLGIST I WORK IN CYSTIC
FIBROSIS.
THE BIGGEST BURDEN IS TRAVEL TO
PLACES.
AND SO THINKING ABOUT THIS AS
NOW WITH COVID, DECENTRALIZED
RESEARCH, HOW TO MEET PEOPLE
WHERE THEY LIVE RATHER THAN
MAKING THEM TRAVEL LONG
DISTANCES WHEN POSSIBLE IS
INCREDIBLY VALUABLE FOR PEOPLE,
REMOTE TECHNOLOGIES FOR RESEARCH
WHEN FEASIBLE IS ALSO REALLY
HELPFUL SO THAT NOTION OF BURDEN
THAT YOU'RE IDENTIFYING IS A
CRITICAL ISSUE AND WE HAVE TO
THINK CAREFUL FROM PERSPECTIVE
OF PARTICIPANTS WHAT WILL MAKE
THESE FEASIBLE, NOT WANTS
CONVENIENT FOR US.
SO MUCH OF MY WORK IS REGARDING
CONSENT FOR CLINICAL RESEARCH.
IN FACT I'M WORKING ON A PROJECT
WITH THE CYSTIC FIBROSIS
FOUNDATION ON GENE THERAPY
RESEARCH.
AGAIN, TECHNICAL AREA, THAT'S
WHY THEY ARE FAMILIAR.
WE DON'T HAVE TO MAKE IT
TECHNICAL.
OTHER AREA OF FOCUS IS GENETICS,
JUST COMPLETED A VERY LARGE
TRIAL OF SEQUENCING, 900 HEALTHY
ADULTS FROM DIVERSE BACKGROUNDS
INCLUDING PEOPLE WHO SPOKE
SPANISH WITH GENOME SEQUENCING.
YOU DON'T NEED TO KNOW ABOUT
BASE PAIRS TO BE INVOLVED .
WE CREATE EXTRA COMPLEXITY AND
NEED TO FIND OUT WHAT'S
IMPORTANT TO PARTICIPANTS.
THERE'S OPPORTUNITY WITH CHANGE
IN FEDERAL REGULATIONS THAT
REQUIRE KEY INFORMATION SECTION,
A SHORT SECTION ABOUT THE MOST
IMPORTANT INFORMATION TO MAKE A
DECISION AND FIGURE OUT HOW TO
MAKE A DECISION WITH IMPORTANT
INFORMATION, NOT THE DETAILS,
SIMILAR TO MAKING DECISIONS IN
LIFE CHOICES INCLUDING BUYING A
HOUSE, MOST DON'T UNDERSTAND ALL
THE THINGS IN THERE.
WE NEED TO KNOW THE IMPORTANT
STUFF.
COMMUNITY ENGAGEMENT IS THE WAY
WHICH YOU FIGURE OUT WHAT IS
IMPORTANT AND THE LAST THING IS
ONE THING I'M FOND IS FOR ANY
CLINICAL RESEARCH STUDY THROUGH
COMMUNITY ENGAGEMENT WITH
FAMILIES IS FINDING OUT THREE
REASONS WHY A PERSON MAY WANT TO
JOIN, MAY NOT WANT TO JOIN,
COMMUNICATING THAT TO FUTURE
PEOPLE HELPS THEM DECIDE WHAT
THEY EXPECT AND THAT'S PERHAPS
THE MOST EFFICIENT WAY OF SIMPLY
HELPING PEOPLE MAKE DECISIONS
ABOUT JOINING A TRIAL KNOWING
WHAT ARE THE MAJOR REASONS SOME
MAY SAY YES AND SOME SAY NO.
I'LL STOP THERE.
>> THANK YOU.
THAT WAS GREAT.
AND WE'LL COME BACK ON THE
DISCUSSION.
WE HAVE TIME AT THE END.
TWO MORE TALKS I WANT TO MAKE
SURE WE GIVE OUR OTHER SPEAKERS
THEIR ALLOTTED TIME.
I THINK WE HAVE DR. MORRELL'S
SLIDES READY.
>> GO TO THE SECOND SUPPLIED.
I APOLOGIZE, TEAMS HAD TAKEN
CONTROL OF MY COMPUTER.
I DO NEED TO BEGIN BY SAYING I
EXPLAINED MY CONFLICTS OF
INTEREST, PROVIDING PERSPECTIVE
I MIGHT OFFER AND I'VE BEEN
INVOLVED IN DESIGN AND CONDUCT
OF CLINICAL TRIALS FOR DRUG
RESISTANT EPILEPSY.
I DO WANT TO SAY, AND THIS IS
HISTORICAL, THAT WHEN WE BEGAN
THE INITIAL TRIALS TO
DEMONSTRATE THE SAFETY AND
EFFECTIVENESS OF THIS
NEUROMODULATION DEVICE, IN
DISCUSSIONS IN THE EARLY 2000s
WITH FDA, THE REQUEST WAS THAT
THESE TRIALS BE CONDUCTED ONLY
IN INDIVIDUALS 18 YEARS OF AGE
OR OLDER.
I THINK IT'S A TESTAMENT TO
EVOLUTION AND THINKING ABOUT
ACCESS TO TREATMENT FOR CHILDREN
THAT THE CURRENT TRIALS WHICH
ARE INVESTIGATIONAL DEVICE
EXEMPTION CLINICAL TRIALS IN TWO
TYPES OF EPILEPSY HAVE BEEN ABLE
TO INCLUDE PARTICIPANTS AGES 12
AND ABOVE.
NEXT SLIDE.
AS I THINK ABOUT THIS, THIS
REALLY SPEAKS TO WHAT BEN AND
WHAT ADAM WERE SPEAKING, WHEN
YOU'RE THINKING ABOUT TRIALS IN
PEDIATRIC THERAPIES, OF COURSE I
HAVE TO BE UNDERSTANDING OF THE
DISORDER ACROSS THE LIFESPAN,
WHETHER THE DISEASE IN CHILDREN
IS THE SAME AS THE DISEASE IN
ADULTS, THERE'S ALSO ELEMENT OF
URGENCY.
HOW GREAT IS THE NEED, HOW MUCH
TIME DO WE HAVE TO HELP THESE
CHILDREN.
WHEN OF COURSE CLINICAL TRIAL
DESIGN MAY BE DIFFERENT FOR
CHILDREN THAN ADULTS, TOTALITY
OF RISK, WHAT BENEFITS MEANS TO
A CHILD THAT MAY BE DIFFERENT
THAN WHAT BENEFIT IS TO AN
ADULT.
WE'RE ALSO CONSIDERING THE VALUE
OF CONTROLLED CLINICAL TRIALS
WHICH WITH BIASED IN MANY WAYS,
WE TALKED ABOUT WILLINGNESS OR
ABILITY TO ACCESS CLINICAL
TRIALS VERSUS THE REAL WORLD
EXPERIENCE THAT IS OFTEN THE
CASE IN PEDIATRICS SINCE
CLINICAL TRIALS TEND TO
REPRESENT CHILDREN LESS OFTEN
THAN ADULTS.
THERE'S EXECUTION.
SO FINANCIAL SUPPORT FOR
PEDIATRIC TRIALS, REALITY IS
PATIENTS GENERALLY ARE LESS
PREVALENT THAN ADULT PATIENTS.
FOR COMPANIES MAKING FINANCIAL
DECISIONS, THE MARKET SIZE FOR
MANY PEDIATRIC APPLICATIONS IS
NOT AS GREAT AS FOR ADULTS, AND
THEN WHY DO FAMILIES CHOOSE TO
PARTICIPATE IN TRIALS,
PARTICULARLY IF THERAPIES THAT
ARE APPROVED IN ADULTS THAT ARE
USED BY PHYSICIANS BECAUSE OF
THE NEED AND CAN BE ACCESSED,
WHY ASSUME THE ADDITIONAL BURDEN
OF THE ACTIVITIES INVOLVED WITH
CLINICAL TRIAL ALSO THE
POSSIBILITY A CHILD WILL AT
LEAST FOR SOME PERIOD OF TIME
NOT RECEIVE ACCESS TO THE
THERAPY.
SOMETHING I'M BEEN CONVINCED OF
WE CAN'T DO PEDIATRIC TRIALS,
CAN'T DO ADULT TRIALS EITHER BUT
MORE SO PEDIATRIC TRIALS WITHOUT
CONSIDERING THE ENTIRE
CRITICALITY OF PARTNERSHIP FOR
EVERYONE WHO TOUCHES DELIVERY OF
THERAPY.
NEXT SLIDE.
I STRUGGLED WITH DETERMINING
ENDPOINTS IN TRIALS.
FOR EPILEPSY, IT'S OBVIOUS WE
HAVE TO LOOK AT SEIZURE
FREQUENCY, SEVERITY OF SEIZURES,
BUT THERE'S INFORMATION
INCLUDING DATA FROM OUR OWN
TRIALS THOSE ONLY HAVE MODERATE
CORRELATIONS WITH QUALITY OF
LIFE AND IT IS IN FACT
MODERATING FACTORS YOU SEE
LISTED THERE THAT ARE AS
IMPORTANT AND MAYBE MORE
DIFFICULT, WHERE ENENDPOINTS
HAVE TO BE OBJECTIVE BECAUSE
THEIR LEADING TO A REGULATORY
DECISION.
NEXT SLIDE.
AND THEN TIME.
I FEEL BEING A CARE PROVIDER AS
WELL AS HOPEFULLY CARE DELIVERER
WE HAVE TO REALIZE THAT THESE
TAKE A LONG TIME.
WE HAVE TO TO BE COGNIZANT THAT
WE'RE DEALING WITH A CHILD WHO
MAY NOT HAVE YEARS.
NERVOUS SYSTEM MAY NOT HAVE
YEARS.
WE REALLY HAVE TO CONSIDER WHAT
THE COSTS OF DOING NOTHING ARE
BECAUSE THAT'S A VERY REAL COST
THAT NEEDS TO BE WEIGHTED
AGAINST THE RISK OF THE DEVICE.
HOW LONG DO THESE TRIALS NEED TO
BE, PARTICULARLY THOSE TRIALS
DURING WHICH A CHILD MIGHT NOT
RECEIVE ACCESS TO A POTENTIALLY
BENEFICIAL THERAPY?
AS I MENTIONED BEFORE IT CAN BE
VERY DIFFICULT TO RECRUIT IN
PEDIATRIC TRIALS WHEN THE DEVICE
IS ACCESSIBLE BECAUSE OF ADULT
APPROVALS AND WE HAVE FOUND THIS
OURSELVES.
AND SO INTEREST IN WHETHER WE
CAN EXTRAPOLATE DATA FROM ADULT
EXPERIENCES TO CHILDREN.
AND NEXT SLIDE.
AND FDA HAS BEEN LOOKING AT THIS
AND ACKNOWLEDGING THAT THERE IS
NOT ENOUGH SCIENTIFIC EVIDENCE
TO SUPPORT THE APPROVAL OF
DEVICES THAT COULD BE INDICATED
FOR TREATMENT OF CHILDREN.
AND SO, LEVERAGING CLINICAL DATA
ACROSS THE BOARD, WHETHER THIS
BE ADULTS IN CONTROL OF CLINICAL
TRIALS OR REAL WORLD EVIDENCE
MAY BE SUFFICIENT TO SUPPORT
APPROVAL FOR USE IN PEDIATRICS.
THERE'S AN EXAMPLE OF THIS,
RELATIVELY RECENT EXAMPLE, IN
2017 OF EXTRAPOLATION OF DATA
FROM ADULTS, FROM RELATIVELY
SMALL NUMBER OF CHILDREN IN A
REGISTRY IN JAPAN, ACTUALLY JUST
30, TO EXTEND APPROVAL, AGAIN AS
TO CHILDREN.
IN FACT, CDER, THE DRUG GROUP,
HAS COME FORWARD WITH A VERY
STRONG RECOMMENDATION THAT
EXTRAPOLATION BE APPROPRIATE FOR
CHILDREN EVEN LESS THAN ONE YEAR
OF AGE.
NEXT SLIDE.
IN TERMS OF WHO IS GOING TO DO
THESE TRIALS, PARTICULARLY IF
THE POPULATION IS RELATIVELY
SMALLER, AS IS THE CASE FOR MANY
PEDIATRIC NEUROLOGICAL
DISORDERS, MANY FALL INTO THE
RARE DISEASE CATEGORY, NIH HAS
REALLY BEEN VERY PROGRESSIVE AND
ENABLING, AND THIS IS OFTEN
THROUGH THE BRAIN INITIATIVE.
BUT ONE EXAMPLE IS A TRIAL THAT
NEUROPACE IS CONDUCTING IN A
CHILDHOOD EPILEPSY, AND THE
NETWORKS INVOLVED IN THIS TRIAL
ARE NOT WELL UNDERSTOOD.
AND SO THIS IS A TRIAL THAT HAS
CLINICAL OBJECTIVES TO
DEMONSTRATE SAFETY OR TO EXPLORE
SAFETY AND SHOW SOME EVIDENCE
FOR EFFICACY, BUT IT IS ALSO A
TRIAL OF BASIC SCIENCE TO
FUNDAMENTALLY UNDERSTAND.
AND THIS INITIATIVE HAS INVOLVED
MANY CLINICAL CENTERS AND
ENABLED A STUDY IN AN EPILEPSY
THAT AFFECTS LESS THAN 5,000 OR
6,000 CHILDREN IN THE UNITED
STATES, AND THAT WOULD NOT HAVE
HAPPENED OTHERWISE.
NEXT SLIDE.
OTHER OPPORTUNITIES ARE TO
COLLABORATE WITH THE CARE
PROVIDER GROUPS THAT ARE
PROFOUNDLY INTERESTED IN
DELIVERING CARE TO PEDIATRICS.
ONE EXAMPLE FROM EPILEPSY IS
RESEARCH CONSORTIUM, MORE THAN
60 CENTERS IN THE UNITED STATES,
AND MANY PROVIDERS WHO TREAT
CHILDREN WITH EPILEPSY AND ON
THEIR OWN THEY HAVE FORMED 11
YEARS AGO A VERY EFFECTIVE
CONSORTIUM TO PROVIDE A NETWORK
AND INFRASTRUCTURE IN ORDER TO
COLLECT DATA THAT REPRESENTS
WHAT IS IMPORTANT TO CHILDREN
AND FAMILIES DEALING WITH
EPILEPSY, AND TO ALSO PROVIDE
INFORMATION TO SUPPORT OUR
UNDERSTANDING OF THE SAFETY AND
EFFECTIVENESS OF THERAPIES, IN
THIS POPULATION.
THE NEXT SLIDE.
AND SO I WANT TO TALK ABOUT AND
CLOSE WITH WHAT HAS REALLY BEEN
SOBERING TO ME, AND THAT IS THAT
-- AND I WILL HOLD MYSELF
RESPONSIBLE FOR THIS --
BELIEVING I UNDERSTAND WHAT
CHILDREN AND FAMILIES NEED
WITHOUT SUFFICIENTLY LISTENING
TO THE ADVOCATES.
AND I THINK THAT MANY OF THE
GROUPS THAT ARE REPRESENTING THE
INTERESTS OF PATIENTS AND FAMILY
MEMBERS HAVE TURNED TO THE
DISABILITY COMMUNITY, AND
PERHAPS, YOU KNOW, MOST FAMILIAR
TO US THROUGH THE HIV COMMUNITY
AND DENVER PRINCIPLES IN 1983,
SPEAKING TO THE NEEDS OF PEOPLE
WITH LIVED EXPERIENCE TO BE
MAKING DECISIONS ABOUT POLICY
AND PROGRAMMING, AND MAYBE NOT
SO MUCH THE PROVIDERS, MAYBE NOT
SO MUCH OR ENTIRELY OR PRIMARILY
THE REGULATORY AGENCIES THAT I
THINK THOSE IN THE BEST POSITION
TO WEIGH RISK VERSUS BENEFITS
AND THE EFFECT ON THE TOTALITY
OF THE CHILD ARE THOSE WHO ARE
LIVING WITH THE DISORDER.
AND THE NEXT SLIDE, TO PROVIDE
AN EXAMPLE, THE FOUNDATION WHO
HAS BECOME A VERY IMPORTANT
PARTNER TO OUR WORK IN TREATING
THIS RARE DISEASE, AND IT IS OF
INTEREST TO ME, THERE ARE MANY
TREATMENTS FOR THIS CONDITION
THAT ARE NOT APPROVED BY FDA AND
SO COMPANIES ARE NOT ABLE TO
SPEAK TO THEM.
NOT ABLE TO PROVIDE INFORMATION.
BUT THE LENNOX-GASTAULT HAS THIS
STATEMENT, THE DISORDER OF THE
DISEASE IS TOUGH, FINDING
INFORMATION SHOULDN'T BE.
THEY PROVIDE INFORMATION ABOUT
ALL THERAPIES, THAT COULD BE OF
BENEFIT TO CHILDREN WITH THE
DISORDER THAT OTHERWISE IS
THE -- THE OUTCOMES ARE ALWAYS
POOR.
THIS INFORMATION IS PROVIDED SO
THOSE IMPACTED BY THE DISEASE
CAN NAVIGATE.
I THINK THIS IS EXTREMELY
IMPORTANT IN CHOOSING TO BE
IGNORANT ABOUT A THERAPY FOR
CHILDREN IN DESPERATE NEED MAY
NOT BE THE CHOICE THOSE IMPACTED
BY THE DISEASE WOULD MAKE.
AND I BELIEVE THAT I HAVE MY
OBLIGATORY LAST SLIDE, WHICH IS
THE HUB AND SPOKE SHOWING THE
HUSBAND IS THE CHILD BUT JUST
REMINDING US OF ALL THE PLAYERS,
ALL OF THOSE WHO ARE NECESSARY
IN ORDER TO ADVANCE THERAPIES
FOR CHILDREN.
THANKS.
>> THANK YOU, MARTY.
THAT WAS GREAT.
IF I CAN TAKE MY PREROGATIVE AS
CHAIR, I'D LIKE TO POINT OUT
SOME WORK BEING DONE BETWEEN
NIH, FDA, BARDA, AND THE
FOUNDATION FOR NIH, DEVELOPMENT
OF PEDIATRIC MEDICAL DEVICES AND
ABOUT SIX MONTHS AGO WE STARTED
THE DESIGN PHASE, TRYING TO
DEVELOP A BETTER ECOSYSTEM TO
REALLY SUPPORT MEDICAL DEVICES
FOR THE PEDIATRIC INDICATIONS
FOR ALL OF THE REASONS THAT YOU
MENTIONED.
STAY TUNED FOR MORE.
WE HAVE TIME FOR ONE QUESTION.
CLARIFYING QUESTION FOR DR.
MORRELL?
SEEING NONE, WE HAVE ONE MORE
SPEAKER.
FINAL SPEAKER OF THE SESSION IS
DR. JENNY BLUMENTHAL-BARBY,
ASSOCIATE DIRECTOR OF CENTER FOR
MEDICALET ETHICS AND HEALTH
POLICY, BAYLOR, SHE'S A
PHILOSOPHER, RESEARCH FOCUSES
PRIMARILY ON ETHICAL ISSUES
RAISED BY RESEARCH ON HUMAN
JUDGMENT AND DECISION MAKING.
I'LL TURN IT OVER.
>> THANK YOU, CHRISTINE.
THERESA, LET ME TRY TO SCREEN
SHARE.
SLIDES OKAY?
>> LOOKS GOOD.
>> GREAT.
ALL RIGHT.
I'M GOING TO START OUT, I
APPRECIATED THE FRAMING OF THE
TASK WHICH IS TO THINK A LITTLE
BIT ABOUT WHAT IS UNIQUE WITH
RESPECT TO PEDIATRIC
NEUROSTIMULATION.
AS OPPOSED TO SOME OF THE MORE
GENERAL ETHICAL ISSUES IN
PEDIATRICS.
I PUT TOGETHER THIS VENN
DIAGRAM, I WAS TRYING TO THINK
ABOUT SORT OF ALL OF THE MAJOR
CATEGORIES OF CONSIDERATION WITH
RESPECT TO PEDIATRIC
NEUROSTIMULATION.
WHAT I WOULD SAY IS THAT IT'S
THIS SORT OF CONGLOMERATION THAT
MAKES THE ETHICS OF
NEUROSTIMULATION UNIQUE, THAT WE
HAVE ALL OF THESE FACTORS
FEATURED TOGETHER AT ONCE.
AND I'M GOING TO TALK A LITTLE
BIT ABOUT SOME OF THESE
SPECIFICALLY.
THINKING ABOUT THIS ETHICAL
ISSUE OF UNCERTAINTY, SO MY TEAM
AS PART OF A BRAIN-FUNDED
PROJECT, MY STRUCTURED
INTERVIEWS WITH 29 CLINICIANS
WHO CARE FOR CHILDREN WITH
REFRACTORY DYSTONIA, ABOUT
EXPERIENCE ENGAGING IN DECISION
MAKING ABOUT DEEP BRAIN
STIMULATION.
72% SAID THE MOST CHALLENGING
ETHICAL ISSUE WAS DEALING WITH
UNCERTAINTY ABOUT RISKS AND
BENEFITS AND MANAGEMENT FOR THIS
POPULATION.
AND THEY TALKED A LOT ABOUT JUST
THE LACK OF RESEARCH, THE LACK
OF TRIALS, THE FACT THAT MANY
DIFFERENT INTERVENTIONS WERE
STILL IN THE TRIAL PHASE, THEY
WERE STILL HAVING RESEARCH DONE
AROUND THEM, THEY WEREN'T,
QUOTE, FDA STAMPED.
A LOT MIGHT HAVE HAD HD
EXEMPTION, THEY WEREN'T WIDELY
USED.
THEY TALKED ABOUT HOW THERE WAS
A LOT OF UNCERTAINTY ABOUT MORE
LONG-TERM EFFECTS AND OUTCOMES
ESPECIALLY WHEN IT CAME TO
CHILDREN.
ALSO JUST THE ASPECT OF
PEDIATRIC NOVELTY THAT HAS BEEN
MENTIONED WHEN YOU'RE DEALING
WITH CHILDREN YOU'RE DEALING
WITH DIFFERENT TARGETS FOR
STIMULATION.
AND ALL OF THIS TOGETHER JUST
CREATED SOME REALLY ETHICALLY
COMPLEX DECISION MAKING TO TRY
TO NAVIGATE.
ONE CLINICS SAID HOW DO YOU
PROGRAM PEOPLE?
EVERYBODY DOES WHAT THEY LEARNED
IN TRAINING.
KIND OF GO OFF WHAT THEY ARE
COMFORTABLE.
I DON'T THINK ANYBODY REALLY
KNOWS WHAT THE IDEAL WAY IS OF
PROGRAMMING KIDS.
SO, I THINK, YOU KNOW, FOR ME
ONE OF THE MAJOR TAKEHOMES
THROUGH THIS RESEARCH IS THAT WE
JUST NEED A LOT MORE
NEUROSTIMULATION TRIALS IN THE
CONTEXT OF PEDIATRICS.
WE NEED MORE DATA.
WE NEED MORE INCENTIVES FOR
THESE TRIALS TO TAKE PLACE.
WE NEED INFRASTRUCTURE AND
INCENTIVES FOR DATA SHARING AS
HAS BEEN MENTIONED IN SOME OF
THE PREVIOUS PRESENTATIONS
AROUND COLLABORATIVE AND
CONSORTIUM, THOSE ARE ALL GREAT
AVENUES TO TRY TO JUST CREATE
MORE DATA FOR PEOPLE TO MAKE
INFORMED DECISION MAKING AROUND.
I THINK WE ALSO THEN NEED TO
TRANSLATE THIS RESEARCH TO FAIR
AND BALANCED MATERIALS TO
SUPPORT FAMILY DECISION MAKING
ABOUT WHETHER TO ENGAGE IN
RESEARCH OR WHETHER TO ENGAGE IN
EVEN A CLINICAL MEDICAL DECISION
ABOUT WHETHER TO GET A
NEUROSTIMULATION DEVICE FOR
THEIR KIDS, AND SET
EXPECTATIONS.
ONE OF THE INTERESTING ASPECTS
IN OUR RESEARCH WE FOUND AROUND
SETTING EXPECTATIONS WITH
PATIENTS IS THAT WE DID THESE
INTERVIEWS, 44 INTERVIEWS WITH
CAREGIVERS WHO WERE THE PARENTS,
WE ALSO TALKED TO 29 CLINICIANS.
AND 86% OF THE CLINICIANS THAT
WE TALKED WITH EXPRESSED A LOT
OF CONCERNS TO US ABOUT PARENTS
AND CAREGIVERS HAVING FALSE
HOPES, AND 69% EVEN SAID THEY
INTENTIONALLY TRIED TO LOWER
PARENTS' EXPECTATIONS ABOUT WHAT
SOME OF THESE NEUROSTIMULATION
DEVICES COULD DO FOR A CONDITION
LIKE DYSTONIA.
WHEN WE TALKED WITH CAREGIVERS
WE FOUND 73% OF THEM DESCRIBED
THEMSELVES AS HAVING HIGH HOPES
BUT REASONABLE EXPECTATIONS.
AND I THOUGHT THAT WAS A REALLY
INTERESTING AND IMPORTANT
FINDING.
SO, WE HAVE ALL THIS UNCERTAINTY
BECAUSE WE DON'T HAVE A LOT OF
DATA, AND I'M SAYING THAT WE
NEED MORE RESEARCH IN PEDIATRIC
NEUROSTIMULATION, THAT LEADS TO
THIS ETHICAL CONCERN ABOUT
VULNERABILITY.
I WOULD SAY THAT TRUE CHILDREN
ARE VULNERABLE TO RESEARCH HARMS
AND RISKS, CANNOT PROVIDE
CONSENT FOR THEMSELVES, ALSO
BEEN ALLUDED TO AS WELL CHILDREN
ARE VULNERABLE BECAUSE OF A LACK
OF RESEARCH, THAT SHOULD NOT BE
LOST.
I THINK THERE ARE INTERESTING
LESSONS TO DRAW FROM OTHER
CONTEXTS SO THIS SLIDE IS
BORROWED FROM MY COLLEAGUE
MIRANDA WAGNER, WHO HAS DONE
WORK TALKING ABOUT
PROTECTIONISM, VULNERABILITY,
HARM, IN THE CONTEXT OF RESEARCH
WITH PREGNANT WOMEN.
SHE REMINDS US HOW THE
THALIDOMIDE TRAGEDY IN THE
'60s PROMPTED A PROTECTIONIST
ETHIC THAT LED TO THE EXCLUSION
OF PREGNANT PEOPLE FROM CLINICAL
RESEARCH STUDIES.
SO THE FDA EXCLUDED WOMEN WHO
WERE PREGNANT OR OF CHILD
BREAKER POTENTIAL FROM EARLY
PHASE STUDIES IN THE LATE
'70s, ANOTHER EXAMPLE IS
PREGNANT PERSONS DEEMED
VULNERABLE IN FEDERAL
REGULATIONS UNTIL THE MOST
RECENT RESCISSION TO THE COMMON
RULE.
THERE'S A LACK OF KNOWLEDGE
ABOUT SAFETY AND CORRECT DOSING,
AND THAT PUTS PREGNANT PEOPLE
AND FETUSES AT RISK.
SHE HAS DISTINGUISHED BETWEEN A
PROTECTIONIST ETHIC AND ETHICS
OF PROTECTION.
THEY CALLED FOR THIS
PROTECTIONIST ETHIC THAT
PRIORITIZED ELIMINATION OF
REPRODUCTIVE RISK BY PROTECTING
VULNERABLE POPULATIONS FROM
RESEARCH BE ELIMINATED, FOR US
TO MOVE TOWARDS ETHICS OF
PROTECTION WHICH RECOGNIZES THAT
HARMS THAT STEM FROM RESEARCH
EXCLUSION WOULD PRIORITIZE
PROTECTION THROUGH RESEARCH.
I THINK THERE ARE KIND OF
SIMILAR LESSONS TO DRAW HERE IN
THE CONTEXT OF RESEARCH AROUND
PEDIATRIC NEUROSTIMULATION THAT
WE WANT TO EMBRACE IN ETHICS OF
PROTECTION RATHER THAN
PROTECTIONIST ETHICS.
ANOTHER ASPECT IMPORTANT TO
CONSIDER IN THE CONTEXT OF
PEDIATRIC NEUROSTIMULATION
RESEARCH AND CARE IS THIS ISSUE
OF ACCESS AND COST AND INSURANCE
THAT HAS COME UP IN OTHER
PRESENTATIONS AS WELL.
THERE ARE REALLY LARGE ISSUES IN
PARITY AND ACCESS SO INTEREST
DOES NOT COVER THESE
INTERVENTIONS, ONLY SOME FAMILY
CAN AFFORD INTERVENTION OR HAVE
ACCESS TO PARTICIPATION IN THE
TRIALS.
SO, HERE IS AGAIN FROM OUR
RESEARCH ONE OF THE PERSPECTIVES
FROM A CLINICIAN WE INTERVIEWED
THAT EXPLAINED RECHARGEABLE
BATTERIES ARE NOT INCLUDED IN
THE HUMANITARIAN DEVICE
EXEMPTION, SO THEY ARE NOT
APPROVED FOR PATIENTS WHO
ACTUALLY NEED RECHARGEABLE
BATTERIES LIKE OBSESSIVE
COMPULSIVE DISORDER AND DYSTONIA
WHERE THEY NEED MORE BATTERY
CHANGES.
THOSE THAT NEED IT MOST CAN'T
GET IT PAID FOR.
SOME CLINICIANS EXPRESSED
UNCERTAINTY EVEN EXASPERATION
OVER WHO SHOULD BE EXPECTED TO
PAY FOR CONTINUED CARE.
RESPONDENT ABOVE, WHO IS
FIGHTING, YOU, BILLING PEOPLE,
PARENTS, EVERYBODY?
AND THEN THE FINAL ASPECT THAT
I'LL TOUCH ON IS SORT OF THIS
CHUNK OF ISSUES IN THINKING
ABOUT IMPACTS ON THE SELF AND
LONG-TERM EFFECTS BECAUSE THIS
IS ONE AREA WHERE
NEUROSTIMULATION SINCE IT
INVOLVES THE BRAIN DOES HAVE
SOMEWHAT UNIQUE ASPECTS IN TERMS
OF EFFECTS ON THE SELF IN A MORE
PERSONAL IDENTITY SORT OF WAY AS
OPPOSED TOKER ISSUES IN
PEDIATRICS.
SO, I THINK ONE WAY TO THINK
ABOUT OR FRAME THIS ISSUE IS
ADMIT AND ACKNOWLEDGE THAT OF
COURSE IT'S THAT
NEUROSTIMULATION CAN HAVE
POTENTIAL IMPACTS ON THE CHILD'S
SELF, AND SOME OF THOSE MIGHT BE
LONG TERM, AND THEY MIGHT EVEN
BE IRREVERSIBLE IN THE CONTEXT
OF A DEVELOPING BRAIN.
ALSO TO REMIND OURSELVES THERE
ARE LONG-TERM EFFECTS ON THE
PEDIATRIC SELF IF WE DO NOT
INTERVENE.
ONE OF THE PAPERS FROM OUR
PROJECT THAT IS STILL IN
PREPARATION KIND OF TOUCHES ON
THIS, AND INVOLVED TALKING TO
THE ACTUAL ADOLESCENT PATIENTS,
WITH SEVERE OCD, ABOUT 21 OF
THEM, ALSO THEIR PARENTS, 19 OF
THEM.
WE WERE ASKING THEM THEIR
OPINION ON POTENTIAL FUTURE DEEP
BRAIN STIMULATION FOR TREATMENT
FOR THEIR CONDITION, WHICH IS
NOT APPROVED FOR CHILDREN YET,
NOT EVEN UNDER HDE, THOUGH IT IS
FOR ADULTS UNDER HDE.
IT WAS INTERESTING A LITTLE OVER
HALF OF THEM EXPRESSED THE VIEW
AND TO US THE INSIGHT DEEP
BRAINSTEM LAYINGS WOULD HAVE A
POTENTIAL POSITIVE IMPACT ON
THEIR PERCEPTIONS OF SELF AND
IDENTITY.
IT REALLY TALKED TO US ABOUT THE
IMPACT OF OCD ON THE SELF, AND
SOME OF THOSE IMPACTS ON THEIR
SELF FROM THE OCD WERE LONG TERM
AND THEY WERE UNWANTED.
THEY TALKED ABOUT THE KIND OF
SOCIAL IMPACTS OF OCD ON THEIR
IDENTITY AND ON THEIR SELF THAT
WERE UNWANTED IMPACTS.
AND HERE IS A QUOTE FROM ONE OF
THE PARTICIPANTS.
WHEN THINKING ABOUT THE
POTENTIAL FOR DEEP BRAIN
STIMULATION, IF IT WOULD
POTENTIALLY WORK, THEY SAID I
WOULD JUST BE ABLE TO EXPERIENCE
MORE AND FIND OUT WHO I AM
WITHOUT THE OCD BECAUSE IT'S A
PRETTY BIG PART OF ME, IT TAKES
UP A LOT OF TIME.
SO, JUST TO END WITH THIS, THIS
FIGURE AGAIN, AND SAY I THINK
THAT PEDIATRIC NEUROSTIMULATION
BRINGS IN A LOT OF KIND OF
TRADITIONAL PEDIATRIC ETHICS
ISSUES BUT IT BRINGS IN SOME NEW
ONES, UNIQUE ONES, AROUND
IMPACTS ON THE SELF FOR EXAMPLE
BUT FOR ME IT REALLY IS JUST
THIS COMBINATION OF ALL THESE
THINGS TOGETHER THAT I THINK
MAKES THIS SPACE SORT OF
ETHICALLY RICH AND COMPLEX.
AND THERE'S ONE FINAL THING THAT
I WANTED TO MENTION TO THIS
GROUP THAT WAS A LESSON FROM THE
RESEARCH OUR TEAM HAS BEEN DOING
THAT'S NOT PART OF THAT FIGURE
BUT IT'S THINKING ABOUT SOME OF
THE REQUIREMENTS FOR SOCIAL
SUPPORT OR FAMILY SUPPORT FOR --
THIS HAS BEEN MENTIONED BEFORE,
FOR ENTRY IN TRIALS, WHAT KIND
OF SUPPORT AND STRUCTURE IS
THERE BUT ALSO FOR ACTUAL
TREATMENT.
SO, WHEN WE DID THE 29
INTERVIEWS WITH CLINICIANS WHO
CARE FOR CHILDREN WITH
REFRACTORY DYSTONIA AND REFERRED
SOME TO GET DEEP BRAIN
STIMULATION, 97% OF THEM SAID
THAT THEY CONSIDER FAMILY OR
SOCIAL SUPPORT IN DETERMINING
CANDIDACY FOR DEEP BRAIN
STIMULATION.
THIS MAKES SENSE BECAUSE
CHILDREN ARE DEPENDENT ON THEIR
PARENTS OR THEIR FAMILY FOR CARE
AND FOR FOLLOW-UP.
BUT I WANT TO POINT OUT I THINK
THERE'S A REAL CONCERN THAT THIS
KIND OF IDEA OR CONCEPT CAN
FUNCTION TO SMUGGLE IN BIAS,
DISPARITIES, UNFAIR TREATMENT.
WE CAN TAKE LESSONS FROM TOTALLY
DIFFERENT CONTEXT WHICH IS ORGAN
TRANSPLANTATION.
ONE OF MY COLLEAGUES KAREN LA
DEAN HAS DONE WORK LOOKING AT
THE CRITERIA OF SOCIAL OR FAMILY
SUPPORT AS A CRITERION FOR ORGAN
TRANSPLANTATION, WHAT THAT MEANS
AND HOW IT IS USED.
AND IN HER WORK THEY DID A LARGE
SURVEY OF 551 PROVIDERS FROM
202 TRANSPLANTERS IS, 86% USED
LACK OF SOCIAL SUPPORT TO
EXCLUDE CANDIDATES FROM
TRANSPLANTATION.
BUT THEY ALSO FOUND THAT THERE
WAS WIDE VARIATION IN WHAT THAT
MEANT, LIKE THE CONCEPT OF
FAMILY OR SOCIAL SUPPORT MEANT,
HOW IT WAS ASSESSED, ALSO A
CONCERNING AND SIGNIFICANT LACK
OF EVIDENCE ON THE IMPACT OF
SOCIAL OR FAMILY SUPPORT ON
ACTUAL OUTCOMES.
I THINK THAT'S SOMETHING THAT WE
IN ETHICS AND CLINICAL COMMUNITY
NEED TO BE CAUTIOUS ABOUT AS WE
KIND OF DEVELOP CRITERIA FOR
PEDIATRIC NEUROSTIMULATION
THERAPIES AND PARTICIPATION IN
TRIALS, TRYING TO GET THIS
BALANCE OF OF COURSE ESPECIALLY
BECAUSE IT'S CHILDREN, YOU KNOW,
WE HAVE TO THINK ABOUT FAMILY
SUPPORT AND SOCIAL SUPPORT, BUT
WE ALSO WANT TO BE REALLY
CAREFUL TO CLARIFY WHAT WE MEAN
BY THAT AND WHAT EVIDENCE WE
HAVE AND WHETHER WE CAN MAKE
ACCOMMODATIONS AS SOME OF THE
OTHER PRESENTATIONS HAVE ALLUDED
TO.
SO THAT'S ALL I HAVE.
I JUST WANT TO THANK THE NIH FOR
THE FUNDING FOR OUR RESEARCH AND
OF COURSE MY TEAM MEMBERS WHO
HAVE HELPED CONTRIBUTE TO THIS
RESEARCH THAT WE'VE BEEN
PRESENTING SOME OF TODAY.
I WILL STOP SHARING MY SLIDES.
>> THANK YOU.
WE'RE DOING GREAT ON TIME.
I'M GOING TO OPEN UP THE FLOOR
TO SEE IF THERE ARE ANY
QUESTIONS FOR JENNY.
I'LL SAY THANK YOU FOR BRINGING
UP PREGNANT PEOPLE.
THAT'S A HUGE AREA OF CONCERN
FOR NICHD, AND SUPPORTING THE
INCLUSION OF PREGNANT PEOPLE IN
TRIALS.
NOW I SEE A BUNCH OF HANDS SO
I'LL BE QUIET.
THEY ARE JUMPING AROUND.
WE'LL START WITH SYD PLEASE.
>> THANKS.
SO, I REALLY APPRECIATE ALL OF
THE SPEAKERS WHO MENTIONED THIS
ISSUE OF ACCOMMODATIONS AND
INCLUSION FOR CHILDREN WHOSE
FAMILIES HAVE DIFFICULTY GETTING
THEM TO APPOINTMENTS OR VARIOUS
OTHER THINGS BECAUSE OBVIOUSLY
THESE ISSUES OF LIMITED ACCESS
EXTEND WELL BEYOND THE CLINICAL
TRIAL PHASE AND INTO WHO IS
GOING TO BE ABLE TO ACCESS THESE
THERAPIES, EXPENSIVE THERAPIES,
AFTERWARDS, SHOULD THESE THINGS
BE APPROVED AND WE NEED TO WORRY
OF COURSE ABOUT EXPLOITING
CHILDREN WHO WILL NEVER BE ABLE
TO AFFORD THESE THERAPIES LATER
ON SHOULD THEY BECOME AVAILABLE.
I WONDER IF ANY OF THE SPEAKERS
HAVE ANY SPECIFIC THOUGHTS ABOUT
WHAT KINDS OF ACCOMMODATIONS
WOULD BE USEFUL OR EFFECTIVE,
THERE'S OBVIOUSLY TRANSPORTATION
ISSUES.
I REVIEWED A GRANT RECENTLY THAT
WAS TRYING TO RECRUIT PEOPLE
WITH SPINAL CORD INJURIES, THEY
MENTIONED SPECIFICALLY THEY
WOULD PROVIDE TRANSPORTATION FOR
THESE INDIVIDUALS BECAUSE THE
LACK OF TRANSPORTATION AVAILABLE
FOR THEM MADE IT DIFFICULT FOR
THEM TO ACCESS THE CLINICAL
SITE.
IF YOU HAVE THOUGHTS ABOUT WHAT
KINDS OF ACCOMMODATIONS WOULD BE
HELPFUL OR USEFUL THAT WOULD
INCREASE THE DIVERSITY OF THE
PARTICIPANTS IN THESE TRIALS,
AND INCREASE ACCESS.
>> ADAM RAISED A HAND TO ANSWER.
>> I WOULD BE HAPPY TO TAKE A
FIRST STAB.
ONE THING THAT'S UNIQUE HERE
WITH A TRIAL IS DIFFERENT THAN
ROUTINE CLINICAL CARE.
SOMETIMES THERE'S FREQUENTSLY
ENDS POINTS THAT HAVE TO BE MET.
IT'S NOT UNIQUE TO DEVICES.
WE SEE IT WITH
NEURODEVELOPMENTAL OUTCOMES, ET
CETERA.
TRIAL CONTEXT IS DIFFERENT.
THERE'S DISCUSSION ABOUT
DECENTRALIZED CLINICAL TRIALS
PARTICULARLY WITH TECHNOLOGY IF
THERE ARE WAYS THAT THERE CAN BE
REMOTE PROGRAMMING, REMOTE
SENSING, SOME OF WHAT I TALKED
ABOUT WITH REQUIREMENT, I
INTENTIONALLY DID THAT, WHEN I
MENTIONED THIS, WHERE YOU HAVE
TO COME INTO THE CLINIC TO HAVE
THAT DONE.
IF THAT CAN BE DONE REMOTELY
THAT'S FANTASTIC.
ANOTHER THING TO THINK ABOUT,
SOME PUBLIC AID AGENCIES ALSO
HAVE SOCIAL WORKERS AND CASE
MANAGERS WHO CAN HELP WITH SOME
ASPECTS OF THIS.
THE STUDY ITSELF MAY BE ABLE TO
PROVIDE SOME ACCOMMODATIONS.
I MEAN, YOU CAN'T RUN UP
NECESSARILY THE BILL ON ONE OR
TWO PATIENTS, BUT THERE ARE SOME
REASONABLE ACCOMMODATIONS I
THINK THAT CAN BE MADE AND I
THINK THERE'S A POINT THAT -- I
CAN'T REMEMBER WHO MADE IT,
ABOUT FORETHOUGHT WITH ENGAGING
COMMUNITY MEMBERS WHEN YOU'RE AT
THE DESIGN STAGE OF THE TRIAL SO
YOU HAVE SOME OF IDEA WHO YOU
WANT TO INCLUDE IN YOUR TRIAL
AND HOW YOU CAN BEST DESIGN THIS
STUDY SO THAT YOU'RE NOT
WALKING -- SAME ARGUMENT WITH
STATISTICS, YOU COME IN LATER,
HERE ARE MY NUMBERS, FIND
SOMETHING FOR ME.
THAT SORT OF THING WE'RE MORE
THOUGHTFUL NOW THAN THE PAST.
>> ANY OTHER COMMENTS TO SYD'S
QUESTION ABOUT ACCOMMODATIONS?
WE HAVE A LOT OF HANDS.
>> I'LL JUST SAY WHAT I PUT IN
THE CHAT, SOMETHING TO THINK
ABOUT, TOTALLY AGREE WITH THE
REMOTE ASPECT, IT'S A BIG
COUNTRY AND PEOPLE CAN BE ALL
OVER, CENTERS OF FOR EXCELLENCE.
THE LICENSING LIMITATION IS
BASED ON, YOU KNOW, STATE
LICENSING BOARDS, A REAL LOW
CEILING ON HOW MUCH WE CAN DO
THAT PRACTICALLY.
A WAY TO GET AROUND THAT, THAT
CAN REALLY DEMOCRATIZE ACCESS,
WHEREVER PATIENTS ARE, TO BE
TREATED BY AND CARED FOR BY
EXPERTS WHEREVER THEY ARE.
>> JOHN?
>> HI, THANKS.
THANKS, JENNY, GREAT
PRESENTATION.
ONE THING IN PARTICULAR, KIND OF
STRUCK ME, MAYBE BECAUSE I'M A
BIT NAIVE IN THIS SPACE, BUT
IT'S YOUR COMMENT THAT GIVEN
THAT WE ARE -- MANY STUDIES ARE
BEING LIMITED BECAUSE WE DON'T
HAVE KNOWLEDGE OR DATA ABOUT
WHAT THE RISKS ARE, THE WAY TO
OVERCOME THAT IS TO DO MORE
EXPERIMENTS, MORE STUDIES, WHICH
AT ONCE IS FOR ME AT LEAST
COUNTERINTUITIVE, ALSO A BIT
OBVIOUS IN RETROSPECT, I THINK
THAT'S INTERESTING BUT ALSO
POSES A VERY INTERESTING AND
CHALLENGING CONUNDRUM FOR US TO
SOLVE.
SO, THAT REALLY STRUCK ME.
THE OTHER PIECE YOU AND OTHER
FOLKS MENTIONED IS THAT DOING
NOTHING IS A DECISION.
AND ESPECIALLY WHEN YOU'RE
DEALING WITH DEVELOPING BRAINS
IT'S PARTICULARLY -- IT'S A
WEIGHTY DECISION.
JUST THE IDEA THAT, OH, WE'RE
NOT GOING TO -- OF COURSE WE
HAVE THIS INGRAINED ETHOS OF
DOING NO MARM BUT DOING NOTHING
CAN DO HARM AS WELL, IT'S ABOUT
BALANCING ASSESSING RISK IN
VULNERABLE POPULATIONS.
I HOPE WE CAN HAVE FURTHER
DISCUSSION AROUND THESE POINTS.
>> I'LL BRIEFLY RESPOND.
I AGREE.
FOR ME A BIG TAKEHOME MOMENT WAS
INTERACTING WITH SOME OF THE
FOLKS WHO -- YOU KNOW, BRAIN
PIONEERS.
I WAS TRYING TO GET A MEETING
WITH THEM ABOUT A PROJECT, AND
THERE WAS A LOT OF HESITATION
FOR THEM TO TALK WITH ME BECAUSE
I WAS AN ETHICIST.
THE PERSON I ENDED UP MEETING
WITH SAID TO ME WE'RE JUST
REALLY TIRED OF YOU GUYS LIKE
SHUTTING DOWN OUR RESEARCH.
WE'RE RESEARCH THAT WE REALIZE
IT'S NEW, IT'S RISKY, NOT A LOT
IS KNOWN BUT LIKE PEOPLE HAVE TO
TAKE THOSE RISKS SO WE CAN
ACTUALLY GET THE DATA SO
IMPROVEMENTS CAN BE MADE.
IT WAS SUCH A POWERFUL POINT.
IT GETS MORE COMPLICATED IN THE
PEDIATRIC CONTEXT BECAUSE
SOMEBODY ELSE IS CONSENTING FOR
SOMEBODY ELSE TO TAKE ON THOSE
RISKS, BUT I JUST NEED TO POINT.
>> CAN I ADD TO THAT?
>> GO AHEAD, BEN.
>> YEAH, JOHN, YOUR QUESTION IS
A GOOD ONE.
IT ACTUALLY POINTS OUT A TENSION
BETWEEN WHAT JENNY AND I WERE
PRESENTING IN OUR TALKS ABOUT
NEED FOR MORE TRIALS VERSUS --
WHEN YOU WERE TALKING ABOUT THE
ISSUE OF EXTRAPOLATION I WORRY
ABOUT THAT.
IN OTHER WORDS, TO ME, THERE'S A
LOT OF RISK FROM THE
EXTRAPOLATION AND APPROVAL
WITHOUT THOSE STUDIES.
I THINK WHAT'S REALLY CRITICAL
IS FIGURING OUT HOW TO DO MORE
STUDIES IN PEDIATRICS BECAUSE
ALTERNATIVE IS NOT TO DO NOTHING
BUT DO IT WITHOUT STUDIES IS
EXTRAPOLATE AND WE THINK WE'VE
GOT IT RIGHT AND AT LEAST THE
HISTORY OF PEDIATRICS WE ALWAYS
GET IT WRONG.
AND WE ARE CONSTANTLY FIGURING
OUT ALL THE THINGS WE'VE MESSED
UP IN TERMS OF THINGS WE THOUGHT
WORKED UNTIL WE FIGURED OUT THEY
DIDN'T WORK.
I WORRY ABOUT THAT ALL THE TIME.
TO ME, TRIALS ARE CRITICAL
BECAUSE WE OFTEN DON'T KNOW OR
DON'T DO THE RIGHT TRIALS.
>> SO, BEN, I AGREE, BUT I THINK
THAT IN MANY INSTANCES WE CAN
IDENTIFY THE DISORDER AS
BEHAVING SIMILARLY IN CHILDREN
AS IN ADULTS, SO THAT'S ONE
DISTINCTION.
IF YOU FEEL UNDERLYING
MECHANISMS ARE THE SAME, THAT'S
ONE THING.
I'M SPEAKING FOR MYSELF RIGHT
NOW, THE CRITICALITY OF REAL
WORLD DATA.
AND BECAUSE YOU CAN'T SAY TO A
CHILD OR PARENT, YOU CAN'T HAVE
ACCESS TO A TREATMENT THAT HAS
BEEN EFFECTIVE IN THOUSANDS AND
THOUSANDS OF ADULTS, WE'RE NOT
GOING TO LET YOU HAVE ACCESS
BECAUSE THERE'S NOT BEEN THE
TIME OR THE WILL OR THE APPROVAL
TO DO THESE CONTROLLED TRIALS.
WHAT YOU CAN SAY IS YOU CAN HAVE
ACCESS TO THIS TREATMENT BUT WE
CANNOT USE YOUR EXPERIENCE
BECAUSE THE EXPERIENCE OF EVERY
CHILD RECEIVING THIS NEW THERAPY
IS IMPORTANT.
MANY ADVERSE EFFECTS OF THESE
THERAPIES YOU CAN'T SEE, TOO
SHORT, AND WE'RE DEALING WITH
POPULATION OF PARENTS WHO ARE
MOTIVATED, ABLE TO TRAVEL, WHO
TRUST THE RESEARCH SYSTEM, YOU
KNOW, AS WE KNOW THERE ARE
CULTURES WITHIN THE UNITED
STATES THAT ARE MUCH LESS LIKELY
TO FEEL COMFORTABLE ENGAGING IN
RESEARCH.
SO, I DO BELIEVE THAT WE HAVE
PUT MORE WEIGHT ON CLINICAL
TRIALS AND LESS VALUED THE REAL
WORLD DATA NOT SUFFICIENTLY.
>> CAN I JUMP IN?
MY QUESTION WAS ON THAT.
THANKS, MARTHA.
I WAS WONDERING ARE WE THINKING
ABOUT RESEARCH TOO NARROWLY AS
RANDOMIZED CLINICAL TRIALS, AND
THEN IT BEGS THE QUESTION SO
WE'VE DEALT WITH THIS IN OTHER
AREAS.
WE HAVE BEEN WORKING ON A PAPER
AROUND LIKE COMMERCIAL SPACE,
TOTALLY DIFFERENT, IT'S THIS
IDEA YOU'RE GETTING ACCESS TO
SOMETHING THAT VERY FEW PEOPLE
GET ACCESS TO, IS THERE SOCIAL
OBLIGATION TO CONTRIBUTE DATA
AND PARTICIPATE IN RESEARCH
RELATED TO THAT.
IF YOU'RE PRESCRIBING OFF-LABEL
USE TO CHILDREN OF THESE SORT OF
NOT EASILY ACCESSIBLE VERY
EXPENSIVE DEVICES, DO WE HAVE --
IS THERE SOME SORT OF BIGGER,
BROADER SOCIAL OBLIGATION TO
PARTICIPATE IN REAL WORLD TRIALS
OR OTHER TYPES OF STUDIES, DATA
COLLECTION, DATA SHARING, THAN
YOU MIGHT HAVE IN A TYPICAL
RESEARCH SETTING AND HOW DO WE
THINK ABOUT ETHICS OF THAT?
I JUST WANTED TO THANK YOU FOR
SAYING THAT BECAUSE I TOTALLY
AGREE.
>> IT GETS TO THE COMMENTS, THE
OTHER COMMENTS, WE HAVE TO DO
EVERYTHING WE CAN TO LESSEN THE
BURDEN OF PARTICIPATION.
>> CAN I MAKE ONE QUICK COMMENT
ABOUT EXTRAPOLATION BEFORE WE
LOSE IT BECAUSE IT'S SOMETHING
THAT BEN AND MARTY BROUGHT UP.
PEDIATRIC EPILEPSY IS AN AREA
THERE'S BEEN FDA DID PRETTY
FORWARD LEANING ON EXTRAPOLATION
WITH MEDICATIONS.
AND SO THE CAVEAT I'M NOT FROM
FDA, CAN'T SPEAK FOR FDA, THE
WAY THAT THE EFFORT HAS
BASICALLY COME TOGETHER IN A
PRACTICAL SENSE, BECAUSE BEN AND
I PRESCRIBE MEDICATIONS ALL THE
TIME IN AN OFF-LABEL WAY.
IT'S ALMOST THE JOKE, IT'S
ALMOST MALPRACTICE IF WE
PRESCRIBE SOMETHING THAT'S ON
LABEL BECAUSE IT'S SO UNCOMMON.
THAT'S BETTING A LITTLE BIT
BETTER BUT IN THE EXTRAPOLATION
SPACE THERE'S TWO COMPONENTS, WE
HIGHLIGHTED IN OTHER COMMENTS.
FIRST IS THAT FOCAL ONSET
SEIZURES, BASIC PATHOPHYSIOLOGY
IS LARGELY THE SAME BETWEEN
CHILDREN ALL THE WAY DOWN TO,
YOU KNOW, AT LEAST A YEAR OF AGE
UP THROUGH ADULTS.
FDA HAS REQUIRED SAFETY STUDIES
IN THOSE, IN THAT CONTEXT, TO
BETTER FRAME THAT RISK/BENEFIT.
SO IT'S NOT LIKE THERE'S A MAGIC
WAND PRACTICALLY SPEAKING,
HASN'T BEEN A MAGIC WAND, ALL OF
A SUDDEN EVERYTHING IS FINE.
BUT WITH THE ADDITION OF AND
SAFETY STUDIES LOOKING DIFFERENT
THAN COMBINED EFFICACY
EFFECTIVENESS IN SAFETY STUDIES,
AND SO THERE HAVE BEEN I THINK
OVER TIME THIS HAS BEEN VERY
POSITIVE DEVELOPMENT, IT'S
LIMITED AND SO ONE WOULD LIKE TO
SEE THAT EFFORT SCIENTIFICALLY
AND THOUGHTFULLY EXPANDS, THAT
GETS TO THE POINT THAT BEN IS
MAKING IN RESPONSE TO JOHN'S
QUESTION ABOUT THIS TENSION
BETWEEN HOW DO WE WORK OUR WAY
INTO THAT MEANINGFUL AND
IMPACTFUL STUDY SPACE SO WE CAN
LOOK A FAMILY IN THE EYE AND
SAY WE HAVE SOME LARGER
KNOWLEDGE, MORE THAN MY
N-of-1 OR N-OF-2 ANECDOTAL
EXPERIENCE WHEN WE WRITE THAT
PRESCRIPTION.
>> I'M GOING TO PASS THE BATON
TO CHRISTINE TO CONTINUE WITH
THE DISCUSSION.
THANK YOU.
>> THANK YOU SO MUCH.
BEFORE I ASK MY QUESTION AND
THEN CONTINUE THE MODERATION, I
WANT TO WELCOME AMY BECAUSE WE
WELCOMED YOU BEFORE YOU CAME,
AMY BUT NOW THAT YOU'RE HERE,
NICE TO HAVE YOU.
I WAS GOING TO ASK ABOUT
EXTRAPOLATION.
SINCE ADAM SAID WHAT HE SAID
I'LL MOVE TO A DIFFERENT
QUESTION.
THE ONE I WAS GOING TO THINK
ABOUT WAS BUILDING ON WHAT SYD
SAID.
I REALLY THINK THAT WE DO NEED
TO PROVIDE MORE ACCOMMODATIONS
FOR PEOPLE WHO CANNOT OTHERWISE
AFFORD TO BE IN A TRIAL OR
AFFORD SOME THINGS TRIALS
REQUIRE.
BUT I THINK WE ARE AT ODDS WITH
OURSELVES IN TERMS OF HOW TO DO
THAT BECAUSE WE'RE ALWAYS
FIGHTING ABOUT HOW MUCH
INCENTIVE TO PROVIDE, AND BEN
RAISED THE POST TRIAL QUESTION,
THE BIG QUESTION, WHO IS GOING
TO PAY FOR IT?
IT'S ALWAYS HOW DO WE DO THOSE
ACCOMMODATIONS IN REAL LIFE, IN
THE WORLD OF THE INFRASTRUCTURE
OF THE CLINICAL TRIAL WORLD WE
LIVE IN, AND I DON'T KNOW IF
PEOPLE HAVE IDEAS BUT IT'S A
REAL -- WE BUTT HEADS.
IF ANYONE WANTS TO ANSWER THAT
I'D LOVE AN ANSWER, OTHERWISE
I'LL TURN TO DAVID FOR THE NEXT
COMMENT.
>> I'LL MAKE A COMMENT.
>> GO AHEAD, BEN.
>> TWO THINGS.
I FEEL LIKE IN GENERAL I'M IN
FAVOR OF MORE CLINICAL TRIALS
BUT I WANT TO ACKNOWLEDGE MORE
THAT'S POINT ABOUT THE REAL
WORLD DATA WHICH I COMPLETELY
AGREE WITH THAT NO -- I THINK OF
FDA APPROVAL AS A LOW BAR, IT
MEANS WE'RE PRETTY SURE IT'S NOT
GOING TO KILL ANYBODY OR NOT
KILL TOO MANY PEOPLE, BUT WE
ALWAYS NEED MORE DATA ABOUT THE
ACTUAL EXPERIENCE AFTER WHICH,
ALL THE NOTIONS OF TRYING TO GET
REAL WORLD DATA IS CRITICAL BUT
I THINK THE ISSUE ABOUT
ACCOMMODATIONS, AND I HEAR FOCUS
FROM SPECIFICALLY ON POST-TRIAL
ACCOMMODATIONS THAT I BELIEVE IS
THE PLACE WE CAN FIND COMMON
GROUND.
IN OTHER WORDS, I THINK THAT
EVEN WHEN WE HAVE A NEED FOR
MORE TRIALS, THINGS APPROVED, I
THINK THINKING THOUGHTFULLY
ABOUT WHAT WE CAN DO FOR THOSE
PARTICIPANTS TO ENSURE IF WE
HAVE EVIDENCE OF SOME EFFICACY
TO CONTINUE THOSE INDIVIDUALS ON
THOSE DEVICES I THINK IS
(INDISCERNIBLE).
>> I COMPLETELY DISAGREE WITH
YOUR COMMENT ABOUT FDA APPROVAL
BEING A LOW BAR.
I COMPLETELY DISAGREE.
>> OKAY.
>> WANT TO SAY WHY?
I THINK ACTUALLY THERE'S --
WELL, I DON'T KNOW.
I THINK THERE'S BEEN AN
APPROPRIATELY HIGH BAR AND IT'S
THE ASSESSMENT OF BENEFIT WHERE
I BELIEVE THE PATIENT'S VOICE
COULD BE BETTER HEARD, THAT'S MY
PERSONAL OPINION.
WE MAY NOT HAVE ALL THE RIGHT
PEOPLE AT THE TABLE DISCUSSING
WHAT THE RESULTS OF THE TRIAL
MEAN.
ACTUALLY WE HAVE DR. McMULLEN
WHO CAN BE THE VOICE OF FDA.
>> CAN I CLARIFY?
MAYBE I OVERSPOKE.
I'M SAYING THIS BASED ON HAVING
BEEN ON THE FDA ADVISORY
COMMITTEE AS WELL AS CONSULTING
FOR MANY YEARS, HUGE AMOUNT OF
ENTHUSIASM FOR THE WORK OF THE
FDA.
I WAS NOT TRYING TO BE CRITICAL
OF THE FDA.
BUT MY POINT IS THAT WHEN WE
MAKE DECISIONS FOR APPROVAL OF
DRUGS, IT'S OFTEN THE CASE THAT
IT HAS MET A THRESHOLD TO GO
FORWARD.
AS YOU POINTED OUT IT'S ONLY
AFTER WE DO ADDITIONAL RESEARCH
WE UNDERSTAND HOW WELL TO USE
THAT.
AND I THINK ONE OF THE
CHALLENGES IN CLINICAL PRACTICE
IS THAT MANY OF THE QUESTIONS
THAT CLINICIANS HAVE ARE NOT
ANSWERED BY FDA APPROVAL.
HOW DO WE CHOOSE BETWEEN DRUG A
VERSUS DRUG B, HOW DO WE COMBINE
THESE?
THERE'S A LOT OF WORK OUTSIDE
FDA APPROVAL THAT IS NEEDED FOR
CLINICAL PRACTICE.
A LOW BAR, WE HAVE REASON TO
BELIEVE IT'S SAME.
WE HAVE REASONS TO BELIEVE IT
CAN BE EFFECTIVE.
BUT WE STILL DON'T REALLY KNOW
WHAT TO DO WITH IT WHEN THE
PERSON SHOWS UP IN CLINIC THE
NEXT DAY.
I'M TRYING TO MODIFY MY
COMMENTS.
>> THANK YOU, BEN, FOR
CLARIFYING.
DAVID, NOW YOU CAN DEFEND THE
FDA.
NO, YOU DON'T HAVE TO.
>> I WANT TO FOLLOW UP, JENNY,
WITH YOUR CONCEPT OF
PROTECTIONISM, AT FDA WE HAVE
LEVERS TO USE, ONE IS WHEN WE
DETERMINE STUDY SIGNIFICANT RISK
REQUIRE STUDY TO BE CONDUCTED
UNDER INVESTIGATIONAL DEVICE
EXEMPTION WHICH MAY BE
ADDITIONAL LAYER OF OVERSIGHT
OVER AN IRB.
HOWEVER, WE CAN LOOK AT THE
DEVICE AND RISKS IT POSES, ALSO
THE STUDY ITSELF IN TOTALITY
INCLUDING THE PATIENT
POPULATION.
I WONDER WHAT YOUR THOUGHTS ARE
THINKING THROUGH WEIGHING THIS
IDEA, THIS FEELS LIKE A
VULNERABLE PATIENT POPULATION,
SO OF COURSE WE WANT TO PROVIDE
ADDITIONAL OVERSIGHT, BUT THE
RISK OF THAT WHICH OFTEN LEAD TO
PATIENT POPULATIONS BEING
UNDERSTUDIED, HOW DO YOU THINK
ABOUT THAT TENSION AND HOW FOLKS
EVALUATE IT?
>> I'LL JUST SAY I ALMOST PUT IN
THIS SLIDE LIKE A COMMENT ABOUT
THE OMISSION BIAS BECAUSE MY
MAIN RESEARCH IS IN DECISION
MAKING AND BIASES IN HUERISTICS.
THIS PLACE A HUGE ROLE HERE THAT
WE HAVE THIS SORT OF TENDENCY TO
NOT WANT TO CAUSE HARM BUT WE'RE
OKAY WITH ALLOWING HARM EVEN IF
THE HARM IS GREATER, RIGHT?
AND THIS HAS COME UP, THIS
OMISSION, AND WE JUST NEED TO
OWN LIKE A NON-DECISION IS ALSO
A DECISION, A DECISION TO DO
NOTHING ALSO POSES RISKS AND
POTENTIAL ARMS, KEEPING THAT IN
MIND, CHECKING OURSELVES ABOUT
THAT I THINK IS REALLY CENTRAL
HERE.
>> GREAT.
THANKS.
ADAM, IF YOU DO WANT TO SPEAK ON
BEHALF OF FDA WE'RE ALWAYS
HIRING.
>> DON'T YOU DARE, ADAM.
>> HEY, WATCH IT, DAVID.
[LAUGHTER]
>> WINSTON?
>> I GUESS BROADENING THE
DISCUSSION ABOUT ACCOMMODATIONS
AND BIASES OF INDIVIDUAL
JUDGMENTS, SOCIAL AND FAMILY
SUPPORT, I THINK THAT THIS IS
SOMETHING I SEE IN DEMENTIA AND
I IMAGINE ANALOGOUS CASES IN
PEDIATRICS, THE DESIGN OF OUR
TRIALS AND DESIGN OF OUR
INTERVENTIONS ENCODES ECONOMIC
BIAS ABOUT THINGS LIKE WHAT
FAMILY SUPPORT LOOKS LIKE, WHAT
SOCIAL SUPPORT LOOKS LIKE.
A LOT OF OUR TRIALS REQUIRE
PRESENCE OF A SPOUSE CAREGIVER,
TURNS OUT IN REPRESENTATIVE DATA
LESS THAN 10% OF DEMENTIA
CAREGIVERS ARE SPOUSE
CAREGIVERS, BLACK AND HISPANIC
CAREGIVERS ARE MORE LIKELY TO BE
YOUNGER WORKING AGE CAREGIVERS
LIKE CHILDREN OR GRANDCHILDREN
WHO CAN'T SHOW UP FOR THE KINDS
OF TRIALS THAT OFTEN ASSUME
PEOPLE WITH WILLING TO
PARTICIPATE DURING THE DAY TIME,
WORKING HOURS, THAT'S ONE THING
WE'RE LEARNING THAT'S BEEN A
BARRIER TO INCLUSIVE
PARTICIPATION.
I THINK THAT THIS MIGHT CONNECT
UP WITH THE POINT ABOUT
COMMUNITY ENGAGEMENT EARLY, NOT
JUST A POINT OF HAVING SOMETHING
AND ENROLLING PEOPLE BUT WHAT'S
THE DESIGN OF THE INTERVENTION,
WHAT'S THE WAY THIS IS SUPPOSED
TO WORK, IS THIS SOMETHING THAT
CAN WORK FOR ALL FAMILIES OR ARE
WE MAKING SOME ASSUMPTIONS ABOUT
WHAT THE PARENTS LOOK LIKE, WHAT
THE PARENTS' AVAILABILITY IS,
WHAT RESEARCH PARENTS HAVE.
THOSE PROBLEMS ARE GOING TO
PERSIST NOT JUST IN THE DESIGN
OF A TRIAL BUT ALSO IN WHETHER
OR NOT THESE INTERVENTIONS ARE
USEFUL TO A LOT OF PEOPLE WHO
NEED THEM.
JUST A WAY OF POTENTIALLY
BROADENING THAT DISCUSSION AND
MAKING A PLEA FOR REALLY EARLY
ENGAGEMENT WITH COMMUNITIES THAT
MAY NOT LOOK LIKE THE ONES WE
SEE IN TERTIARY CARE SETTINGS,
PEOPLE WHO HAVE ACCESS TO
CURRENT HIGH TECHNOLOGY
INTERVENTIONS.
>> GREAT POINT.
SAMEER?
>> THANKS.
REALLY FUN DISCUSSION.
A BIT OF A NEW TOPIC WHICH HAS
TO DO WITH THE QUESTION THAT
ADAM ASKED AFTER YOUR TALK, WHAT
OF THESE THINGS IS PEDIATRIC
SPECIFIC.
OVER THE COURSE OF THE TALKS I
WAS THINKING ABOUT THIS IDEA
WHICH IS RELATED TO THE THING
THAT YOU SAID, PROBABLY THE MOST
SPECIFIC, THE DEVELOPING BRAIN.
BUT IT'S NOT THE SAME.
THIS POINT IS ONE OF UNINTENDED
CONSEQUENCES, NEUROMODULATION,
IN TERMS OF CHANGING SOMETHING
ABOUT THE IDENTITY PERSONALITY
ET CETERA OF THE INDIVIDUAL, AND
MAYBE THIS IS MORE LIKELY TO
HAPPEN IN YOUNG INDIVIDUALS,
PEDIATRIC POPULATION, BECAUSE OF
BRAIN DEVELOPMENT, ET CETERA.
AND A COUPLE EXAMPLES, JEN
TALKED ABOUT THE OCD PATIENTS.
REALLY AGREE LIKE THE EXAMPLE
YOU GAVE WAS THE QUOTE SOMETHING
WHO SAID KNOW WHO I AM BETTER,
OCD TAKES OVER, YOU KNOW, YOU
AND ERIC, MANY OTHERS.
A LOT PATIENTS WITH OCD, ADULTS,
WITH NEUROMODULATION, EVERYONE
SEES IT AS SOMETHING OTHER THAN
THEMSELVES, HAPPY TO SEE IT GONE
AS MUCH AS POSSIBLE.
THERE'S BEEN NO REGRET, I WISH I
HAD SOME OF THAT BACK.
ON THE OTHER HAND, THERE'S
DISCUSSION IN KIND OF PUBLIC
MEDIA STUFF REGARDING ASD
VERSION AND SOME, YOU KNOW,
THINGS FROM - AFFECTED
INDIVIDUALS AND CAREGIVERS,
NON-INVASIVE NEUROMODULATION,
ASD, THIS PERSON HAS CHANGED, IN
SOME WAYS BETTER, OTHER WAYS
KIND OF I AS A PARENT DON'T
APPRECIATE OR I AS THE
INDIVIDUAL MISS.
I WONDER IF THIS MIGHT HAPPEN OR
MIGHT BE PRONE TO HAPPENING MORE
IN YOUNGER INDIVIDUALS BECAUSE
THINGS ARE CHANGING AND WE
ALWAYS HAVE TO DECIDE, YOU KNOW,
WHEN TOE INTERVENE WITH THESE
KINDS OF NEUROMODULATION
INTERVENTIONS IN TERMS OF
NATIONAL COURSE OF THE DISORDER
ITSELF AND WHETHER THINGS MAY
IMPROVE AND HOW THEY MAY
SPECIFICALLY CHANGE WITH
NEUROMODULATION.
WHEN WE'RE TALKING ABOUT
INVASIVE NEUROMODULATION, SORT
OF A TWO-EDGED SWORD, YOU KNOW,
INVASIVENESS IS, OKAY, NOT GREAT
BUT THE GOOD THING IS IT BRINGS
SPECIFICITY IN TERMS OF CIRCUIT
SPECIFICITY.
OFF-TARGET EFFECTS ARE IN
GENERAL LESS COMMON, A GOOD
THING IN TERMS OF UNINTENDED
SIDE EFFECTS.
THAT'S THE WHERE.
THERE'S ALSO THE HOW.
MARTY WITH YOUR DEVICE, THERE'S
A SENSE OF STIMULATING WHEN
NEEDED, NOT WHEN IT'S NOT.
THAT'S ANOTHER LEVER THAT WE
HAVE.
AS WE'RE TRYING TO MINIMIZE
UNINTENDED IMPACT, AWARE, THE
HOW AND WHEN, WHICH I THINK WILL
BE IMPORTANT FOR EVERYBODY BUT I
THINK MAYBE MOST SO IN THE
PEDIATRIC POPULATION.
>> I THINK THAT THIS IS GOING TO
BE A TOPIC THAT'S NOT JUST
PEDIATRICS.
IF WE'RE TALKING ABOUT
RESTORATION OF FUNCTION WHICH I
BELIEVE WE'RE ALL TALKING ABOUT,
THAT'S VERY DIFFERENT THAN
ENHANCEMENT OF FUNCTION.
SO I LIKE TO THINK THAT THE
INTENT AT LEAST OF WHAT WE'RE
TRYING TO DO IS TO RESTORE
HEALTH.
LEAVE EVERYTHING ALONE AND
RESTORE HEALTH.
OF COURSE THEN YOU HAVE TO
DECIDE WHAT A HEALTHY BRAIN
LOOKS LIKES.
IF WE'RE TALKING ABOUT
BEHAVIORAL HEALTH AS WELL AS
PHYSICAL HEALTH, THEN WHO
DECIDES WHAT IS HEALTHY VERSUS
UNHEALTHY BEHAVIORS, THERE'S
SPECTRUM.
AND OCD IS ONE END OF THE
SPECTRUM BUT I WAS INTRIGUED BY
COMMENTS ABOUT ASD.
>> SOMETHING WE CAN PAY
ATTENTION TO IN RESEARCH IN
TERMS OF PATIENT AND CAREGIVER
EXPECTATIONS AND HOPES,
EXPECTATION AND REALITY IN TERMS
OF WHAT HAS CHANGED, WHAT THEY
ARE HAPPY ABOUT, WHAT THEY
REGRET.
>> I'LL COMMENT ON THAT.
>> SURE.
>> I THINK I AGREE WITH YOUR
QUESTION, MARTY'S RESPONSE.
I WANT TO ADD THOUGH THAT I
THINK TWO POINTS.
ONE IS THAT ALL OF US EXPERIENCE
LIFE-ALTERING THINGS THAT HAPPEN
THROUGH CHILDHOOD THAT SHAPE WHO
WE ARE.
SO I THINK THIS NOTION THAT --
THE FACT THIS MIGHT HAVE SOME
SORT OF IMPACT, THAT'S PART OF
LIFE.
THAT WAS MY JOKE ABOUT MARTY
McFLY.
THE REALITY IS WE ALL FACE
ISSUES THAT CHANGE WHO WE ARE,
CHANGE HOW WE THINK IN MANY
THINGS.
I'M GOING TO GIVE YOU, IN MY
CLINICAL AREA, PULMONOLOGY,
CYSTIC FIBROSIS AND DEVELOPMENT
OF THE MODULATORS COMPLETELY
EFFECTIVE IN CHANGING THE COURSE
OF THE DISEASE HAS HAD MANY
UNINTENDED CONSEQUENCES BECAUSE
IT HAS CHANGED WHAT PEOPLE'S
GOALS AND ASPIRATIONS WERE BASED
ON APPRECIATION THEIR LIFE
TRAJECTORY WAS CHANGING.
AND PEOPLE HAVE TO GRAPPLE WITH
THAT.
BUT I THINK -- THEY MAY OR NOT
REGRET IT, I CAN'T SPEAK TO
THAT.
MY POINT IS THAT LIFE CHANGES
AND WE HAVE TO SORT OF DEAL WITH
WHERE WE'RE AT, AT THE MOMENT,
AND I DON'T THINK THIS IS
UNIQUE.
WE ALL FACE THIS ALL THE TIME
FOR ALL OF US.
>> DO YOU WANT TO RESPOND,
SAMEER?
>> YEAH.
NO, IT'S A GOOD POINT, YEAH.
>> OKAY.
AMY?
>> YEAH, I HAVE A QUESTION BUT
I'LL FOLLOW UP REAL QUICK.
I WAS JUST THINKING AS WE WERE
HAVING THIS CONVERSATION I AGREE
WITH YOU, BEN, BUT I ALSO THINK
IT DOES RAISE QUESTIONS ABOUT
SORT OF WHERE IS THE LINE OF
ENHANCEMENT VERSUS TREATMENT,
RIGHT?
IT'S FUNNY BECAUSE I WAS HAVING
THIS DISCUSSION WITH MY HIGH
SCHOOL SON THIS WEEKEND, HE HAD
TO DO A REPORT ON GENE EDITING,
HE DIDN'T SHOW IT TO ME EVEN
THOUGH THAT'S WHAT I DO.
WHAT DID YOU ARGUE FOR?
THERE'S ETHICAL BOUNDARIES.
WHAT ARE THEY?
YOU SHOULD USE IT FOR TREATMENT
BUT NOT ENHANCEMENT.
WHAT'S ENHANCEMENT?
WE GET INTO THIS DEBATE.
HE HAS ADHD.
IS TREATING THAT TREATMENT?
HE SAID ENHANCEMENT, NOT
TREATMENT.
THIS BRINGS UP HOW DO THE
PATIENTS AND THEIR FAMILIES
THINK ABOUT THESE THINGS.
IT GOT ME THINKING ABOUT THAT
STORY, I THOUGHT IT WAS
INTERESTING.
MY REAL QUESTION FOR JENNY, WE
TALKED ABOUT -- I'M GOING BACK
BUT WE TALKED ABOUT SORT OF TWO
THINGS, WE TALKED ABOUT KIND OF
EXTRAPOLATING FROM ADULT TRIALS
AND ALLOWING OFF-LABEL CLINICAL
USE ENHANCING OUR ABILITY TO USE
REALTIME DATA AND COLLECT OTHER
TYPES OF RESEARCH DATA TO INFORM
PEDIATRIC PRACTICE.
AND THEN WE ALSO TALKED ABOUT
INCREASING ENROLLMENT IN
PEDIATRIC TRIALS THEMSELVES, AND
DOING THAT THROUGH TWO
MECHANISMS, ONE REDUCING
BARRIERS THROUGH ACCOMMODATIONS,
AND THE OTHER MENTIONED, JENNY
TALKED ABOUT THIS AS INCENTIVES,
CURIOUS WHAT HAD YOU IN MIND IN
TERMS OF INCENTIVES, WHETHER
LIMITING TO FINANCIAL OR OTHER
TYPES THAT WE MIGHT USE TO
PROMOTE PARTICIPATION IN
RESEARCH.
>> YEAH, THANKS.
WITH INCENTIVES I WAS THINKING
AROUND INCENTIVES FOR LIKE
RESEARCHERS ACTUALLY DOING
CLINICAL TRIALS IF THEY CAN
ALREADY DO A LOT OF THIS STUFF
OFF-LABEL, LIKE WHAT'S INCENTIVE
TO DO RESEARCH OR DATA SHARING,
LIKE REALLY INCENTIVES FOR DATA
SHARING, REPOSITORIES, CONSORTIA
AND THINGS LIKE THAT.
SO THAT WAS THE TARGET OF THE
INCENTIVES COMMENT.
JUST TO CLARIFY.
>> THANK YOU TO THE SPEAKERS FOR
THIS INTERESTING SESSION.
I HAVE A QUESTION FOLLOWING
ON -- I THINK IT WAS BEN'S
PRESENTATION, PERHAPS OTHER
SPEAKERS WOULD BE ABLE TO
COMMENT ON THIS AS WELL.
BEN, I THINK IN YOUR TALK YOU
HAD MENTIONED ASSENT AND
COMMUNITY ENGAGEMENT.
YOU ALSO PROVIDED THE SUGGESTION
AROUND ASSENT THAT FAMILIES
COULD BE PROVIDED A RANGE OF
EXAMPLES FOR DECISION MAKING,
MAJOR FACTORS THAT OTHER
FAMILIES HAVE CONSIDERED.
AND THAT COULD BE USEFUL FOR
OTHER FAMILIES COMING INTO THESE
STUDIES TO DETERMINE WHERE THEY
FALL IN THAT SPECTRUM OF
CONSIDERATION.
I WAS CURIOUS WHETHER THESE
SPECTRUM-BASED DECISION
FRAMEWORKS HAVE BEEN USED IN
OTHER COMMUNITIES PERHAPS EVEN
THE PEDIATRIC EPILEPSY COMMUNITY
WHICH IS QUITE LARGE AND HOW TO
UTILIZE FRAMEWORKS FOR EFFECTIVE
DECISION MAKING THAT BALANCES
THE NEED FOR DEEPER
UNDERSTANDING SO IT'S NOT SO
NUANCED AND NITTY-GRITTY BUT
UNDERSTANDABLE.
>> I'LL TRY TO RESPOND BRIEFLY.
THIS IS SOMETHING I CAN'T SAY IS
UNIVERSALLY DONE.
SOMETHING I'VE BEEN PASSIONATE
ABOUT, STUDY RELATED, EVEN
REVISION OF COMMON RULE, I DON'T
KNOW WHETHER THAT'S IN THERE BUT
IN KEY INFORMATION SECTION THEY
SUGGEST THAT SHOULD HELP PEOPLE
BE ABLE TO MAKE THOSE DECISIONS
BASED UPON THAT.
EVEN OUTSIDE RESEARCH I THINK
THERE'S A LOT OF OPPORTUNITIES
TO SORT OF UNDERSTAND FROM THE
PERSPECTIVE OF FAMILIES, ONE OF
MY OTHER AREAS IS DECISION
MAKING ABOUT TRACHEOSTOMY IN
CHILDREN UNDERSTANDING REASONS
PEOPLE MAY DECIDE TO DO IT OR
NOT, BASED UPON THEIR VALUES,
BASED UPON THEIR PERSPECTIVES,
ALLOWS FAMILIES TO THINK ABOUT
THIS.
I THINK THERE'S A LOT OF
OPPORTUNITY TO DO THIS.
I THINK IT REQUIRES SOME
EMPIRICAL RESEARCH ENGAGEMENT
UNDERSTANDING WHAT OTHERS ARE
THINKING.
I WOULDN'T SAY IT'S WIDESPREAD
AS APPROACH BUT ONE I FEEL IS A
GOOD APPROACH, IT'S SOMETHING TO
THINK ABOUT DECISION MAKING, TO
ME THIS IS A WAY OF TRYING TO
TAKE SOME OF THIS COMPLEX AND
TRYING TO IDENTIFY THE POLES AND
REASONS, EVEN IF NOT CAPTURING
EVERYTHING, SOMETHING TO ANCHOR
ON, OTHERWISE THEY ARE OFTEN
ADRIFT.
HOW DO I THINK ABOUT THIS?
I'M NOT SURE WHAT TO DO NEXT.
>> I THINK THE CONCEPT IS
HELPFUL OF GIVING PEOPLE LIKE
HERE'S SOME MAIN REASONS PEOPLE
DO THIS, HERE'S SOME MAIN
REASONS PEOPLE DON'T.
THAT'S SUPER HELPFUL.
WHERE IT BECOMES MORE
COMPLICATED TO NAVIGATE IF THE
PROPOSAL IS SOMETHING MORE LIKE
PICKING FIVE NARRATIVES THAT
REPRESENT LIKE, YOU KNOW, PEOPLE
WHO DECIDE TO DO IT AND DON'T,
AND WHY THEY MIGHT, THE
BACKGROUND, THEN WE KNOW THERE'S
BIAS, SOMEBODY MIGHT IDENTIFY
WITH, OH, THIS PERSON LOOKS LIKE
ME, THEY COME FROM THE SAME
BACKGROUND AS ME, THAT SHOULD
NOT BE DRIVING THE DECISION
ULTIMATELY.
I WOULD SAY "YES AND," THAT THAT
APPROACH IS REALLY HELPFUL.
>> ADAM?
>> TWO QUICK COMMENTS AND A
QUESTION FOR FELLOW SPEAKERS.
FIRST COMMENT, AMY, WHEN YOU
MENTIONED ADHD AND ENHANCEMENT,
THAT QUESTION, AS SOMEONE WHO
TREATED A LOT PEOPLE WITH ADHD,
MY APPROACH, WE WANTED TO
TREAT -- THIS IS WITH MEDICATION
BUT APPLIES TO DEVICES TOO, TO
ANYTHING, TREAT JUST ENOUGH SO
THEY ARE FUNCTIONAL IN SCHOOL,
BECAUSE THERE ARE A LOT OF
POSITIVE THINGS ABOUT HAVING
ADHD AS WELL, AND THAT FINE LINE
IS DIFFERENT.
IT'S CHALLENGING, A POSITIVE
SENSE SCENARIO.
THE OTHER QUICK COMMENT WAS JUST
SO EVERYONE KNOWS WE HAVE A --
I'LL PLUG NINDS HERE, WE HAVE A
FUNDING OPPORTUNITY FOR
PROSPECTIVE OBSERVATIONAL
STUDIES THAT CAN USE REAL WORLD
DATA.
THEY DO NEED TO BE OBVIOUSLY
PROBESSED AS A STUD -- PROPOSED
IN A WAY TO MAKE SENSE BUT HAPPY
TO TALK ABOUT THAT OFFLINE.
MY QUESTION FOR FELLOW
PANELISTS, IT GETS BACK TO THE
ORIGINAL PANEL WHAT'S UNIQUE
ABOUT PEDIATRICS, HOW DO YOU
THINK -- HOW DO WE FRAME THE
QUESTION OF THIS VARIABLE
RISK/BENEFIT.
SO IS IS AGE DEESCALATION ALWAYS
NECESSARY?
I'M HOPING THAT'S A USEFUL
QUESTION, USEFUL DISCUSSION FOR
MY FELLOW NIH STAFF AS WELL.
DO WE ALWAYS NEED TO DEESCALATE?
IF NOT HOW DO PRE-FRAME THAT,
APPROACH THAT, NOT LESS AEXPECT
AN AN NOT NECESSARILY EXPECT AN
ANSWER.
>> YOU SAID AGE DEESCALATION?
>> YES.
>> WHAT IS THAT?
>> YOU START WITH STUDIES IN
ADULTS, MARCH DOWN TO OLDER AND
YOUNGER ADOLESCENTS.
>> OH, AGE, OKAY.
>> IS THAT ALWAYS NECESSARY, OR
IS THERE A SITUATION WHERE IT'S
CLEAR THAT THE RISK/BENEFIT IS
VARIABLE, GOING BACK TO THE
GRAPH I PRESENTED IN THE CASE.
HOW DO YOU FRAME THE QUESTIONS
ABOUT SKIPPING THAT OR AT LEAST
MODIFYING THAT.
THAT WAS FOR BEN, YOU, AND
JENNY.
>> WE'LL START WITH BEN.
>> I ACTUALLY -- I THINK THE WAY
TO FRAME THE QUESTION IS TO ASK
ARE THERE GOOD REASONS TO
BELIEVE THAT THE RISK/BENEFIT
PROFILE WILL BE DIFFERENT AND
OFTEN THERE ARE.
I THINK WE SHOULD HAVE -- I
DON'T THINK WE SHOULD ASSUME
THERE'S A -- PERHAPS THERE'S
DOGMA OF AGE DEESCALATION, AND I
THINK FOR MANY YEARS I THINK IT
BECOMES PROBLEMATIC BECAUSE IT'S
NOT UNIQUE TO AGAIN PULMONARY AS
WELL, OFTEN THERE ARE
DIFFERENCES IN DEVELOPING LUNG
AT EARLIER TIMING THAT THE
THINGS ARE -- BENEFITS AND RISKS
ARE DIFFERENT INCLUDING
BENEFITS, ONE CONCEPTUAL RISK OF
AGE DEESCALATION IS THAT WE FAIL
TO APPRECIATE WHAT BENEFITS ARE,
ONLY WHEN WE DID THEM IN THE
EARLIER TRIALS THAT WE CAN DO
THAT.
SO I THINK IN TERMS OF PEDIATRIC
ISSUE I THINK WE SHOULD BE
LOOKING CRITICALLY AT THAT.
AND WE SHOULD BE LOOKING FOR
WHEN THERE ARE GOOD REASONS TO
NOT DO THAT AS LONG AS WE HAVE
SOME BASELINE INFORMATION ABOUT
SAFETY IN GENERAL THAT WE
SHOULDN'T HAVE TO PUT SAFETY ALL
THE WAY DOWN THE LINE TO
UNDERSTAND HOW THIS CAN BE
IMPACTFUL.
>> YEAH, I GET CONCERNED FROM
THE PERSPECTIVE OF A COMPANY
DECIDING WHERE TO PUT, IN OUR
CASE, LIMITED RESOURCES.
THE PROBLEM IS, YOU KNOW, IT IT
CAN BE A DECADE OR LONGER BEFORE
A SIMILAR TYPE OF CLINICAL
TRIALS DONE FOR A PEDIATRIC
THERAPY, AND THAT IS SO -- IT'S
JUST UNACCEPTABLY LONG, I THINK.
AND SO PERHAPS THE BAR FOR WHAT
IS ACCEPTABLE SAFETY INFORMATION
SHOULD BE LIKE REALLY LOW TO
START TO INTRODUCE TO A
PEDIATRIC POPULATION BUT WITH
VIGILANCE OVERSIGHT.
VIGILANT OVERSIGHT.
WE DEAL WITH A CONDITION, ADAM
AND I DO, RISK OF SUDDEN DEATH
IS VERY HIGH.
WHERE KIDS' SELF-IDENTITY CAN BE
DESTROYED.
AND NEVER RECORD.
WE FIND IN OUR STUDIES IF PEOPLE
ARE TREATED WITHIN TEN YEARS OF
DIAGNOSIS THERE'S BIG
IMPROVEMENT IN QUALITY OF LIFE.
IF THEY ARE TREATED AFTER 20
YEARS, EVEN WITH THE SAME
REDUCTION FEATURES THEY NEVER
GET A BETTER QUALITY OF LIFE.
THEY HAVE LOST THAT WINDOW.
I THINK A DECADE, THAT'S A TIME
DURING WHICH A LOT OF KIDS ARE
GOING TO BE OUT OF THAT WINDOW.
>> AND TECHNOLOGY HAS CHANGED A
TON IN TEN YEARS, YOU'RE GOING
TO DO A VERY DIFFERENT KIND OF
STUDY.
>> THAT'S TRUE.
>> FOR ME IT'S REALLY THINKING
ABOUT THE HARMS OF THE AGE
DEESCALATION, AND AGAIN IT MAKES
SENSE THAT WE GRAVITATE TO THE
IDEA OF WANTING TO PROTECT KIDS,
RATCHETING DOWN, BUT THAT IS A
KIND OF ETHICAL HUER I.ISTIC BUT
IF WE THINK ABOUT THE GROUNDS,
IS IT OMISSION BY AS, LIKE A
PROTECTIONIST ETHIC WE SHOULD
HAVE LEARNED LESSONS ABOUT FROM
OTHER CONTEXTS, I THINK WE
SHOULD HAVE A HEALTHY SKEPTICISM
ABOUT THAT NOTION.
>> EVERY CASE IS GOING TO BE
SLIGHTLY DIFFERENT, EVERY
DISEASE/STUDY, WHATEVER.
JEN?
>> THANKS.
WHAT A GREAT DISCUSSION.
I WANTED TO BACK TO THE
POST-TRIAL OBLIGATION, A TOPIC
FOR THIS AFTERNOON, A LITTLE BIT
LATER BUT NIGHT BE AMPLIFIED IN
THE PEDIATRIC SPACE.
TO JENNY IN TERMS OF DECISION
TREES DO YOU HAVE REFERENCE
ABOUT DECISION MAKING FOR TRIALS
IN REGARD TO WHAT HAPPENS ONCE
THE TRIAL IS OVER WITH?
WE FOCUS A LOT ON RISK/BENEFIT
DECISION AT THE BEGINNING OF THE
TRIAL AND I'M WONDERING IF
THERE'S DECISION TREE OR
DECISION MODELS FOR PEOPLE
PARTICIPATING BECAUSE OF WHAT
HAPPENS AFTER THE TRIAL AND MY
SECOND QUESTION IS DIRECTED TO
MARTY BUT SOME OTHER PANELISTS
AS WELL, IN TERMS OF OUR -- POST
TRIALS WE SAY WHO IS GOING TO
PAY FOR IT, RIGHT?
I WONDER IF DEVICES IF WE HAVE A
UNIQUE OPPORTUNITY WHERE WE CAN
GATHER REAL WORLD DATA AND
THERE'S GOT TO BE VALUE TO THAT.
WHY ARE WE NOT VALUING IT?
I WANTED TO THROW THAT OUT TO
THE PANEL AS WELL, I'LL START
WITH JENNY.
>> I'LL POP HIS NAME IN THE
CHAT, MY COLLEAGUE GABE HAS DONE
WORK ON POST TRIAL OBLIGATIONS
INCLUDING PEDIATRIC CONTEXT.
HIS WORK IS GREAT TO CHECK OUT.
I'LL DROP HIS NAME IS.
>> I WANT TO MAKE A COUPLE
COMMENTS.
CMS IS VERY HELPFUL IN DIRECTING
DECISIONS THAT INSURERS MAKE.
MOST LARGE ONES WILL FOLLOW CMS
N A PATRIOTIC SITUATION CMS WILL
NOT MAKE A DECISION BECAUSE
WE'RE NOT TALKING ABOUT A
MEDICARE POPULATION SO THERE'S
NO ONE TO SET THE STANDARD AND
WHEN WE STARTED OUR PEDIATRIC
TRIALS MANY OF THE INSURERS AND
CENTERS SAID WHAT IS CMS' POLICY
DECISION?
THERE ISN'T ONE, OF COURSE.
BUT GETTING TO THE POINT ABOUT
REAL WORLD DAD, DEVICES ARE
DIFFERENT THAN DRUGS BECAUSE WE
KNOW WHO THE PATIENTS ARE.
AND WE CONTINUE TO FOLLOW THEM.
SO THERE IS A VISIBILITY THAT
REALLY ENHANCES THE ABILITY TO
GET TRIAL DATA.
IN THE CASE OF OUR DEVICE AND
OTHER DEVICES THERE IS BRAIN
DATA BEING COLLECTED AND STORED
SECURELY BUT IT'S STORED.
AND MOST PATIENTS OPT TO ALLOW
THAT BRAIN DATA TO BE EVALUATED
TO BENEFIT THE INDIVIDUAL BUT
ALSO TO APPLY TO GREATER
UNDERSTANDING OF THE DEVICE.
SO THERE IS AN OPPORTUNITY WITH
DEVICES THAT YOU DON'T REALLY
HAVE WITH DRUGS.
>> GREAT.
SASKIA?
>> THANK YOU FOR A TERRIFIC
PANEL.
I THINK I JUST HAVE A COMMENT
AND QUESTION AND WE CAN TACKLE
IN THE LATER SESSION.
SO MY COMMENT WAS JUST TO REMIND
LISTENERS WHO ARE MAYBE LESS
WELL VERSED IN SOME OF THE
REGULATIONS ABOUT RESEARCH, THAT
A LOT OF THIS DISCUSSION IS
ASSUMING PROTECTIONS IN PLACE IN
THE RESEARCH REGS THAT LIMIT
RISKS, SOME ARE ASSUMING
REGULATORY PROTECTION THAT ARE
IN PLACE.
THE OTHER QUESTION THAT I HAD
WAS -- AND WE MIGHT TACKLE THIS
IN THE NEXT SESSION, IS WHAT IF
ANY NEUROETHICS RESEARCH SHOULD
WE BE DOING TO SUPPORT THIS
FUTURE TRIALS IN TERMS OF
NEUROSTIMULATION IN CHILDREN?
IS THERE A NEED FOR -- WE'VE
HEARD ABOUT COMMUNITY
ENGAGEMENT, ABOUT RESEARCH WITH
PERHAPS OTHER STAKEHOLDERS ABOUT
INFORMED CONSENT.
ARE THERE OTHER NEUROETHICS
STUDIES WE NEED IN ORDER TO
CONDUCT THESE TYPES OF TRIALS IN
THE MOST ETHICALLY APPROPRIATE
WAY?
>> GREAT QUESTION.
CERTAINLY BEN RAISED SOME IDEAS
EARLIER ABOUT COMMUNITY
ENGAGEMENT WORK.
>> I'LL ADD ONE THING.
I THINK ONE WAY OF ADDRESSING
YOUR QUESTION, SASKIA, IS ALSO
THROUGH COMMUNITY ENGAGEMENT,
FINDING OUT ISSUES THEY ARE
STRUGGLING WITH.
I ALSO THINK, I MADE THIS
COMMENT BUT I WANT TO SAY THIS
MORE EXPLICITLY, I THINK THE
OPPORTUNITY WHEN TRIALS ARE
BEING CONDUCTED TO BE
SIMULTANEOUSLY ENGAGING, TRYING
TO NOT GET -- UNDERSTANDING MORE
ABOUT MOST PEOPLE'S EXPERIENCE
DOING RESEARCH WITH THEM,
ENGAGING THEM ABOUT ISSUES THEY
ARE FACING CAN BE DONE IN THE
CONTEXT OF THOSE TRIALS AS AN
OPPORTUNITY TO LEARN MORE SO I
THINK THAT KIND OF -- I WISH
MORE STUDIES WERE LIKE THIS, NOT
JUST STUDYING BIOLOGY BUT THE
SOCIAL DIMENSION OF THE
INTERVENTIONS AND WE ARE SEEING
THAT HAPPENING MORE AND MORE.
THAT'S THE DIRECTION I LIKE TO
SEE THINGS GO.
>> GREAT.
JENNY?
>> THE NOTION OF NEUROETHICS
IMPLEMENTATION RESEARCH, I DON'T
KNOW IF THAT'S A THING BUT IT'S
JUST SOME OF THE IDEAS WE'RE
TALKING THROUGH WE HAVE -- THOSE
WHO DO NEUROETHICS RESEARCH, YOU
KNOW, WE DO ENGAGE WITH
COMMUNITY STAKEHOLDERS AND
PATIENTS AND LEARN WHAT'S ON
THEIR MIND BUT I DON'T KNOW HOW
MUCH THAT GETS CARRIED OVER, AND
SO IF THERE'S LIKE A RESEARCH
MECHANISM THAT COULD BE
DEVELOPED AROUND LIKE
IMPLEMENTATION, LIKE IN THE
DECISION SCIENCES FOR EXAMPLE IF
THAT DOESN'T ALREADY EXIST THAT
COULD BE REALLY USEFUL.
>> THANK YOU.
IN THE INTEREST OF TIME I WANT
TO SUM UP AND THANK THE
PRESENTERS, WHO WERE WONDERFUL.
EACH BROUGHT INTERESTING THINGS
TO THINK ABOUT.
THANK YOU FOR BEING HERE AND FOR
BEING PART OF THE CONVERSATION.
I THANK THERESA FOR MODERATING
THE FIRST HALF OF THE PANEL AND
SAY IT SEEMS LIKE THEMES ARE,
ONE, SOMETHING THAT ADAM STARTED
WITH WE SHOULD BE PROTECTING
CHILDREN THROUGH RESEARCH, NOT
FROM RESEARCH.
AND THIS APPLIES TO
NEUROSTIMULATION RESEARCH AS
WELL AS ANY OTHER KIND AND BE
THOUGHTFUL ABOUT THE KNEE-JERK
INSTINCTS, ADULTS BEFORE KIDS,
OLDER KIDS BEFORE YOUNGER KIDS,
ALL THOSE THINGS WE DO OUT OF
HABIT, WE NEED REASONS.
WE NEED REASONS TO MAKE THOSE
DETERMINATIONS IN EVERY CASE.
I THINK PEOPLE TALKED ABOUT
ACCOMMODATIONS TO INCLUDE PEOPLE
WITH OTHERWISE DIFFICULT SOCIAL
CIRCUMSTANCES TO MAKE IT HARD TO
PARTICIPATE, BEN GAVE IDEAS
ABOUT ASSENT.
I STILL THINK WE WANT TO ANSWER
THE QUESTION WHAT HAPPENS IF A
YOUNG CHILD WANTS THE DEVICE OUT
AND PARENTS DON'T.
THAT'S A HARD SITUATION.
HOPEFULLY WE'LL SUMMARIZE THIS
IN A USEFUL WAY AND HAVE MORE
CONVERSATION WHAT WE CAN DO IF
ANYTHING.
SO THANK YOU ALL.
I THINK IT'S ABOUT TIME TO TAKE
A BREAK.
SHOULD I SAY 15 MINUTES, NITA,
OR MORE?
>> WE'RE AHEAD OF SCHEDULE SO WE
CAN GIVE MORE.
>> LET'S COME BACK AT 2:35.
>> WE'RE LOOKING FORWARD TO THE
NEXT SET OF SPEAKERS AND
CONVERSATION, DOING HORIZON
SCANNING ON EMERGING
OPPORTUNITIES IN NEUROETHICS
RESEARCH, TRYING TO LOOK A
LITTLE BIT TO BOTH THE FUTURE
AND TO SEE WHAT SHOULD BE ON THE
AGENDA FOR NEW GOING FORWARD.
WE HAVE THREE TERRIFIC PEOPLE
JOINING US FOR PRESENTATIONS
WHICH ARE DR. JOE FINS, ALEX
HUTH AND DR. TRISTAN McINTOSH.
I'M GOING TO INTRODUCE JOE FINS,
NO STRANGER TO EVERYONE HERE.
AND AFTER HE'S DONE I WILL
INTRODUCE OUR LATER SPEAKERS.
DR. JOSEPH FINS IS PROFESSOR OF
MEDICAL ETHICS, PROFESSOR OF
MEDICINE AT WEILL CORNELL
MEDICAL CENTER, NEW
YORK-PRESBYTERIAN, ATTENDING
PHYSICIAN AND DIRECTOR OF
MEDICAL ETHICS, IMMEDIATE PAST
PRESIDENT OF INTERNATIONAL
NEUROETHICS SOCIETY, SOMEBODY
WHO IS AN IMPORTANT FIGURE IN MY
LIFE, INSPIRATION AS WELL.
TAKE IT AWAY.
>> THANK YOU TO EVERYBODY FOR
THE GRACIOUS INVITATION TO BE
HERE.
I WAS LISTENING TO THE FIRST
HALF OF THE PROGRAM AND A LOT OF
WHAT I AM GOING TO SAY DOVETAILS
NICELY WITH WHAT YOU GUYS WERE
TALKING ABOUT.
AND HOPEFULLY THE SAME THING
WON'T HAPPEN TO MY SLIDES THAT
HAPPENED EARLIER TO OUR
COLLEAGUE'S SLIDES BUT I THINK
CAN YOU SEE MY SLIDES NOW?
YES, OKAY.
I'M GOING TO TALK ABOUT POST
TRIAL OBLIGATION AND DISABILITY
RIGHTS, A THEME THAT EMERGED
EARLIER, AND REFLECT ON THE
STUDY TALKED ABOUT IN THE
STIMULATION FOR TRAUMATIC BRAIN
INJURY, DRAWING ON EARLIER WORK.
BEN WAS TALKING ABOUT EMBEDDED
RESEARCH IN A TRIAL, EMBEDDED
RESEARCH IN THAT UH3, DONE
SIMULTANEOUSLY, AND THIS IS THE
"NATURE MEDICINE'S" PAPER,
IMPLANTED ELECTRODES IN THE
THALAMUS BILATERALLY AND FIVE
WHO COMPLETED HAD AT LEAST 10%
INCREASE IN TRAIL MARKING TEST
PART B, A MEASURE OF PROCESSING
SPEED.
TWO OF THE FIVE SUBJECTS HAD A
1-POINT INCREASE IN THE GHOSTY
SKILL IN THREE MONTHS OF
STIMULATION, THIS IS
TRACTOGRAPHY OF THE PROJECTIONS
FROM THE THALAMUS, EACH OF THE
FIVE SUBJECTS, DIFFERENT COLORS
SHOWS IT'S GOING TO THE FRONTAL
CORTEX.
THERE'S MORE TO BE SAID ABOUT
THE SCIENCE BUT I'LL FOCUS ON
THE NEUROETHICS.
I WANT TO TELL YOU HOW THIS WORK
GOT STARTED.
WE WERE PLANNING THE UH3 I SAID
TO MY COLLEAGUES, WHO SAID WHAT
HAPPENS IF THE SUBJECTS THINK
THEY ARE BETTER BUT THE DATA
DOESN'T MAKE IT?
OR WE DON'T HIT THE FDA
MILESTONES OF 10% IN THE
AGGREGATE BUT SOME DO AND SOME
DON'T, WHAT ABOUT VOICES OF THE
PARTICIPANTS?
ISN'T THERE KNOWLEDGE IN WHAT
THEY ARE SAYING?
WE'RE TALKING ABOUT SUBJECTIVE
EXPERIENCE.
MEANWHILE FOR THE LAST TEN YEARS
OR SO I'VE BEEN WORKING AT YALE
LAW SCHOOL ON DISABILITY LAW,
DISABILITY RIGHTS, AND THIS
STATEMENT WHICH CAME UP ALSO
THIS MORNING NOTHING ABOUT US
WITHOUT US.
IF WE'RE GOING TO DO THIS WITH
THESE COLLABORATORS, THEY WERE
CALLED PIONEERS, IF WE'RE GOING
TO BE ON THIS WAGON TRAIN WITH
THEM GOING ACROSS THE WEST WE
NEED TO KNOW WHAT THEY ARE
THINKING ABOUT.
AND SO WE WROTE A SUPPLEMENT SO
WE WOULDN'T LOSE ANY OF THE
DATA, I'M GRATEFUL TO JAY AND
CHURCHILL FOR HIS HELP WITH
ORCHESTRATING SOME EARLY WORK,
AND WE GOT A SUPPLEMENT SO WE
WOULDN'T LOSE DATA, INTERVIEWED
THE FIRST SUBJECT IN THE TRIAL.
WE GOT THIS RF1, REALLY AN R01
MECHANISM.
ONE, WE'VE BEEN TALKING ABOUT
REPRESENTATION THAT WHY THIS IS
IMPORTANT SO THESE FOLKS CAN
ARTICULATE THEIR REASONS AND WHY
THEY PARTICIPATE IN THE
PROBLEMS, STRENGTHS AND WEAKNESS
OF THE STUDY, ALSO THERE'S
SCIENTIFIC VALUE BECAUSE A LOT
OF WHAT THEY SAID WAS HYPOTHESIS
GENERATING.
THINGS WE DID NOT STUDY FORMALLY
IN THE STUDY WILL NOW BE
QUESTIONS THAT WE'RE GOING ASK
MORE SYSTEMATICALLY IN FUTURE
STUDIES.
SO IT'S NOT ONLY
REPRESENTATIONAL QUALITIES OF
GETTING A MORE CAPACIOUS VIEW
THROUGH NARRATIVE BUT ALSO THE
SCIENTIFIC VALUE.
THIS IS AN ARGUMENT FOR
EPISTEMIC PLURALISM AND STUDIES
THAT WITH MULTI-DIMENSIONAL.
IF YOU HAVE INSOMNIA AND YOU
NEED SOMETHING TO HELP YOU TO
SLEEP, I WROTE TWO PAPERS ABOUT
OUR NARRATIVES, VERY THICK
DESCRIPTIONS, EACH OF THESE
PAPERS ARE NEARLY 18,000 WORDS
EACH.
IN WHICH WE GIVE VOICE TO WHAT
THE PATIENTS AND THEIR SUBJECTS
AND THEIR FAMILIES SAID, PART 1
SUMMARIZES, IN CAMBRIDGE
QUARTERLY, SUMMARIZES
PREOPERATIVE NARRATIVES BEFORE
IMPLANTED, PART 2 IS
POSTOPERATIVE NARRATIVE.
WE TALKED ABOUT ALL KINDS OF
THINGS, ABOUT INFORMED CONSENT,
THERAPEUTIC MISCONCEPTION, THE
USUAL SUSPECTS.
I WANT TO FOCUS ON PERSONAL
IDENTITY.
WE HAD SEMI STRUCTURED
INTERVIEWS PRE AND POST OP,
EVERYBODY ASSESSED INDEPENDENTLY
BY A CONSULTATION LIAISON
PSYCHIATRY FOR THEIR OWN
DECISION MAKING CAPACITY AND
THEIR ABILITY TO PROVIDE
AUTONOMOUS CONSENT.
I WORKED PREVIOUSLY WITH
PATIENTS IN MINIMALLY CONSCIOUS
STATE.
HOW DID YOU INTERVIEW THEM?
IT'S A DIFFERENT POPULATION,
MODERATE TO SEVERE BRAIN INJURY,
GOSI 5-7, SIX PEOPLE IMPLANTED,
ONE PERSON EXPLANTED FOR MINE
ORINFECTION.
FIVE DYADS COMPLETED.
WE HAD PREOPERATIVE WORD COUNT
IN TRANSCRIPTS OF 69,000 WORDS,
RANGE WAS 6800 TO 15,000,
FAMILIES 3800 TO 18,000.
WE LOST ONE SUBJECT, HAD A
SIMILAR RANGE AND THE LIKE.
TRANSCRIPTS WERE CODED
DEDUCTIVELY AND INDUCTIVELY TO
CONCEPTUAL CODES.
I WAS GREATLY SISSED IT BY
MAYING -- ASSISTED BY MEGAN
WRIGHT, YALE LAW SCHOOL, IN OUR
GROUP, ALSO TRAINED AS A Ph.D.
SOCIOLOGIST.
WE USED HER EXPERTISE TO THIS
REGARD.
THERE WERE LOTS OF THEMES THAT I
WON'T FOCUS ON BECAUSE WE'RE
SORT OF FORWARD LOOKING ON HERE.
I REALLY WANT TO FOCUS ON
PERSONAL IDENTITY.
AND ONE OF THE TROPES THAT WE
OFTEN HEAR ABOUT IN THE
BIOETHICS AND NEUROETHICS
LITERATURE, OFT BEEN THE FEAR
CYBORGS WILL INFILTRATE YOUR
BRAIN WHEN YOU GET A
NEUROPROSTHETIC AND YOU WON'T BE
WHO YOU ARE, BUT THE REALITY IS
ACCORDING TO THE SAMPLE THAT WE
HAD IN OUR STUDY IN TRAUMATIC
BRAIN INJURY, NOT SAYING ALL
BRAIN CONDITIONS BUT IN OUR
STUDY WHAT NARRATIVES SAY, THE
SUBJECTS SAY AND THEIR FAMILIES
MEMBERS SAID, IS THAT BRAIN
INJURY DISRUPTS PERSONAL
IDENTITY AND NEUROMODULATION
RESTORES IT.
AND SO I WANT TO FOCUS ON THAT.
HERE ARE SOME EXAMPLES OF WHAT
THE PREOPERATIVE INTERVIEW SAID.
AND THE MOTHER OF A SUBJECT SAID
THAT THE SUBJECT WAS A TOTALLY
DIFFERENT PERSON, ESSENCE OF MY
DAUGHTER CHANGED FOREVER, I HAD
TO RAISE HER ALL OVER AGAIN.
ONE OF THE SUBJECTS SAID ABOUT
HIMSELF, I WOULD SAY I'M SIMILAR
BUT I'M NOT SURE I WOULD SAY I'M
THE SAME.
THAT PARENT OF THAT SUBJECT SEES
THE SUBJECT AS IMMATURE VERSION
OF HIS FORMER SELF AND SAID, YOU
KNOW, YOU HAVE TO SEPARATE
GETTING THE OLD HIM BACK FROM
GETTING HIM TO A PLACE WHERE
HE'S SUFFERING LESS.
AND ALL OF THE PARTICIPANTS HAD
SOME VERSION OF THIS, OF THIS
STORY.
POSTOPERATIVELY IT'S QUITE
REMARK ANNUAL.
THE SAME MOTHER WHO SAID I LOST
MY DAUGHTER, I LOST MY DAUGHTER,
SAID THE FOLLOWING.
I GOT MY DAUGHTER BACK, I GOT MY
DAUGHTER BACK, IT'S A MIRACLE,
IT'S SO PROFOUND FOR US, IT'S A
PROFOUND CHANGE.
NOW HERE COME THE TEARS.
IF SOMEBODY TOLD ME IN AUGUST WE
WOULD BE SITTING HERE HAVING
THIS KIND OF CONVERSATION IN
JANUARY, I NEVER WOULD HAVE
BELIEVED IT.
IT'S BEYOND MY HOPES, BEYOND
ANTICIPATION, SOMEBODY TURNED
THE LIGHTS BACK ON.
THIS SUBJECT WHO HAD HAD A
DEVASTATING CAR ACCIDENT BEFORE
SHE WAS GOING TO GO TO LAW
SCHOOL, A CAR ACCIDENT WHERE SHE
DIVED UNDER THE DASHBOARD OF THE
FRONT SEAT IN THE CAR SHE WAS
DRIVING SO SHE WOULDN'T BE
DECAPITATED AT THE TOP WAS
SHEARED OFF HAD A TERRIBLE BRAIN
INJURY, COULD NOT READ A BOOK,
COULDN'T -- HAD LACK OF ENERGY,
WOULD GO TO SLEEP AT 5:00 IN THE
AFTERNOON, HAD APATHY, AFTER
STIMULATION SHE HADN'T READ
ANYTHING FOR 19 YEARS, CAME TO
US IN JANUARY AND HAD READ SIX
BOOKS, SUMMARIZING NOVELS SHE
HAD RED.
READ.
THIS IS A GOOD NOVEL, THIS IS
NOT A GOOD NOVEL.
SHE HAD TO MAKE NEW LIFE PLANS
ABOUT GOING BACK TO SCHOOL.
ANOTHER SUBJECT WHO WAS IN THE
TRIAL SAID THAT IT WAS AN
ACCELERATION OF HIS RECOVER.
BEFORE THE IMPLANT, EARLY
MID-TEENS, AFTER THE IMPLANT I
WOULD SAY IT'S BACK TO LATE
TEENS OR MY ACTUAL AGE, WHICH
WAS IN THE EARLY 20s.
THE SAME SUBJECT WHO I JUST TOLD
YOU ABOUT WHO STARTED READING
AGAIN HAD CHALLENGES WITH
ADAPTATION.
I THINK THIS IS A FORWARD SCAN
LOOKING QUESTION.
YOU HELP THESE PEOPLE, BUT WHAT
DO YOU DO TO HELP THEM INTEGRATE
AND GET BACK INTO THEIR LIVES?
IT'S LIKE SOMETHING IS TOLD THEY
DON'T HAVE HUNTINGTON'S DISEASE
AND ALL OF A SUDDEN THEY ARE 45,
NOW WHAT I DO?
I ANTICIPATED I WOULD DIE.
THERE HAVE BEEN SUICIDES IN THAT
CONTEXT WHEN PEOPLE ARE GIVEN
NEWS UNEXPECTED.
THEY DON'T EXPECT TO GET BETTER.
THEY THOUGHT THIS WAS THEIR LOT
AND NOW THEY HAVE TO ADAPT TO
IMPROVEMENTS.
THIS IS A POSITIVE DISRUPTION IN
THEIR LIVES.
SO THE SAME SUBJECT, THIS WOMAN
SAID I DON'T KNOW, I JUST WANT
TO THINK.
I'M BORED.
LIKE READING BOOKS AND STUFF,
WHY?
I WOULD HAVE THOUGHT THAT WAS
BORING.
I'M USING MY MIND AND IT'S
INTERESTING.
I DON'T KNOW WHY.
IT JUST MAKES ME LAUGH.
IT'S AMAZING I ENJOY DOING THESE
THINGS, LIKE I'M A NERD.
YOU GUYS, SCIENTIFIC TEAM, YOU
MADE ME A NERD.
IT'S ALSO ABOUT SOCIAL
RELATIONSHIPS.
AND HER NETWORK OF FRIENDS.
SHE TOLD US I WENT TO LUNCH WITH
MY GIRLFRIEND, I TOLD HER I
LIKED READING.
THIS GIRLFRIEND LOOKED AT ME AND
SAID, WHY?
AND SHE SAID, THAT'S WHEN I
LOOKED AT HER AND JUST KNEW OUR
LIVES WERE GOING IN DIFFERENT
DIRECTIONS.
I NEED A DIFFERENT GIRLFRIEND
NOW.
AND SO THIS IS LIKE A
POSITIVE -- IT'S A GOOD PROBLEM
TO HAVE BUT IT'S A REAL PROBLEM.
AND WE HAVE TO SUPPORT THESE
FOLKS IN ADDITION TO HELPING
THEIR BRAINS GET BETTER, HAVE TO
HELP THEM NOW USE THOSE BRAINS
IN A WAY THAT ALLOWS THEM TO
REINTEGRATE INTO SOCIETY, AND
IT'S A CHALLENGE BECAUSE IT'S
NOT LIKE THEY ARE GOING THROUGH
NORMAL MATURATION IN HIGH SCHOOL
WITH A GUIDANCE COUNSELOR AND
NORMAL TRAJECTORY.
THEY ARE ON A FLIGHT PATH NO ONE
HAS FLOWN BEFORE.
I THINK THIS GETS TO THE
POST-TRIAL OBLIGATIONS FOR THESE
SUBJECTS, AND IT'S NOT JUST THE
BATTERIES.
IT'S BROADER SUPPORT.
ONE OF THE PARENTS SAID, YOU
KNOW, LOOK, THIS IS NOT A
MEDICATION YOU CAN CONTINUE.
HIS BODY IS CHANGED FOREVER
BECAUSE OF THIS DEVICE SO NOT
SUPPORTING IT IS NOT THE SAME AS
NOT APPROVING A MEDICATION AND
THEN JUST NOT MAKING IT
AVAILABLE ANYMORE.
AND I THINK THAT THAT'S WORTH
CONSIDERATION.
AND I THINK THAT, YOU KNOW, A
SAYING, IF YOU BROKE IT, YOU OWN
IT.
NOW THAT WE FIXED IT, WE OWN IT
AS WELL.
ONE OF THE SUBJECTS, QUITE
REMARKABLE, DID A CALCULATION
WITH US ABOUT YOU CAN PAY FOR
THE BATTERIES OR CAN YOU PUT ME
ON DISABILITY INSURANCE.
AND HE SAID, DO I HAVE CONCERNS
ABOUT THE FUTURE?
I MEAN, THE ONLY THING THAT
COMES TO MIND IS REPLACING THE
BATTERY, NO, OTHER THAN THAT,
OTHERWISE I DON'T UNDERSTAND WHY
THE GOVERNMENT IS NOT GIVING ME
DISABILITY INSURANCE OR
SOMETHING.
AND THIS IS GREAT.
LIKE EITHER COVER MY MEDICAL
EXPENSES OR COVER THE
DISABILITY.
PICK ONE, YOU KNOW?
I'D RATHER HAVE THE JOB THAN
COLLECT INSURANCE.
PLUS THE SOCIAL ASPECT IS ALSO
NEEDED.
SITTING HOME ALONE ALL DAY IS
BORING.
I MEAN, THERE ARE SO MANY
REASONS TO GO OUT AND GET A JOB
AND DO SOMETHING.
WE TALK ABOUT ACCOMMODATION,
THESE PEOPLE CAN BE INTEGRATED
INTO SOCIETY.
THEY WANT TO GO BACK TO SOME
SEMBLANCE OF A NORMAL LIFE BUT
IT'S NOT A NATURAL PATHWAY THAT
IS CLEARLY AVAILABLE TO THEM.
HAVING SAID ALL THAT, THERE IS
SOME REALISM TO WHAT CAN AND
WHAT CANNOT BE COVERED.
AND ONE SUBJECT SAID, MY DAD
ASKED HOW LONG THE IMPLANT COULD
BE SUPPORTED OR MAINTAINED.
I'D LIKE IT TO BE IN PERPETUITY.
IT WOULD BE NICE.
BUT HE UNDERSTOOD THERE WERE
SOME LIMITS.
I WROTE A PAPER WITH THE
AFOREMENTIONED GABE LAZAR OH,
AMANDA MERCER AND MEGAN WRIGHT,
BEG PUBLISHED BY THE HASTINGS
CENTER WITH THE SUPPORT OF THE
DANA FOUNDATION.
I WROTE A PAPER WITH THEM CALLED
"IDENTITY THEFT, DEEP BRAIN
STIMULATION, PRIMACY OF DEEP
BRAIN STIMULATION."
TO RESTORE IT AND BECAUSE WE
HAVE POOR POLICY PEOPLE WILL
LOSE IT IF THEY DON'T GET
BATTERIES OR SUPPORT IS A
METAPHORICALLY IDENTITY THEFT.
AND I THINK A FAILURE TO FULFILL
POST-TRIAL OBLIGATIONS, DEPRIVES
THE INDIVIDUAL OF WHAT IS
RIGHTLY THEIRS, THEIR PERSONAL
IDENTITY, IF WE RESPECT PERSONS,
I THINK IDENTITY IS CLOSELY
LINKED, A RESPECT FOR PERSONS
ARGUMENT, I THINK THIS IS
SOMETHING WE REALLY NEED TO TAKE
SERIOUSLY IN A NORMATIVE WAY.
SO, I THINK HERE THE
NEUROPROSTHESIS RESTORES A
FORMER SELF TAKEN AWAY BY
INJURY, THE DEVICE NEEDS
LONG-TERM SUPPORT TO SUSTAIN
BENEFITS.
THEY NEED PSYCHOLOGICAL SUPPORT
FOR ADAPTATION POST A POSITIVE
DISRUPTIVE TECHNOLOGY.
EVERYBODY IN THE STUDY SAID, YOU
KNOW, IT WOULD HAVE BEEN HELPFUL
TO HAVE HAD A PSYCHIATRIST OR
PSYCHOLOGIST TO COUNSEL THEM AS
THEY REALIZE THEIR LIVES ARE
DRAMATICALLY DIFFERENT.
WE DIDN'T KNOW IT WAS GOING TO
BE THIS DRAMATIC, DIDN'T WANT TO
IMPOSE A THERAPEUTIC
MISCONCEPTION, IT WASN'T PART OF
THE STUDY BUT WE HEARD IT.
THE TRIALS NEED PSYCHOLOGICAL
SUPPORT AND THE FOLKS MAKE A
CLAIM UPON US AND THE PUBLIC
PURSE, UNDER DISABILITY LAW.
LET ME ROUND THE CORNER AND
EXPLAIN WHY I THINK THIS IS.
SO, THE ADA, AMERICANS WITH
DISABILITIES ACT, AND CONVENTION
ON THE RIGHTS OF PERSONS WITH
DISABILITIES FROM THE UNITED
NATIONS BOTH TALK ABOUT A
VIOLATION OF HUMAN RIGHTS IF
PEOPLE DON'T HAVE THE
OPPORTUNITY TO BE MAXIMALLY
INTEGRATED INTO CIVIL SOCIETY.
YOU KNOW, WRIT LARGE.
AND I THINK THAT FOR PEOPLE WHO
HAVE A MOTORIC DISABILITY, FOR
EXAMPLE, IT'S THE WHEELCHAIR,
THE CUT IN THE SIDEWALK THAT
ALLOWS THEM TO GO FROM HERE TO
THEIR.
WITH A COGNITIVE DISORDER
DEVICES ALLOW THEM TO ENGAGE, GO
BACK TO SCHOOL, GO BACK TO A
JOB, RESTORE RELATIONSHIPS, AND
THIS IS WHAT I MEAN BY SOCIAL
INTEGRATION.
I THINK THE DEVICE CAN BE
UNDERSTOOD AS AN ACCOMMODATION.
IN A PAPER PUBLISHED IN THE
BOSTON COLLEGE LAW REVIEW WITH
STUDENTS AND FELLOW AT YALE, WE
HAVE A QUOTE, TYPES OF
ACCOMMODATION AND SERVICES
PROVIDED TO INDIVIDUALS WITH
DISABILITIES UNDER ALL TITLES OF
ADA SHOULD KEEP PACE WITH
RAPIDLY CHANGING TECHNOLOGY OF
THE TIMES.
EVEN THOUGH THE ADA WROTE ABOUT
TELEPHONE, TTY FOR DEAF
INDIVIDUALS AS TECHNOLOGY OF THE
DAY, IT WASN'T THAT TECHNOLOGY
THEY WERE WRITING ABOUT.
IT WAS REALLY THE FACT, WHAT DID
THAT TECHNOLOGY ACCOMPLISH, AND
IF THERE'S NEW TECHNOLOGIES THAT
ALLOW FOR INTEGRATION IN A
MEANINGFUL WAY THAT NEEDS TO BE
UNDERSTOOD AS AN ACCOMMODATION.
WE'VE WRITTEN A NUMBER OF
ARTICLES ABOUT THAT.
WE'VE WRITTEN ABOUT THIS NEW
LEGISLATIVE PROPOSAL.
ONE PARADOX AND CIVIL RIGHTS LAW
IF YOU HAVE AN IMMUTABLE
CONDITION LIKE RACE OR GENDER
BEFORE WE HAD MORE GENDER
FLUIDITY, YOU HAVE DIFFERENT
LEVELS OF SCRUTINY IF
DISCRIMINATION AS OCCURRED.
WE HAVE THE PARADOXICAL
SITUATION WHERE IF HE WE CAN
CHANGE YOUR DISABILITY WITH A
NEUROPROSTHETIC YOU HAVE LESS
PROTECTION.
YOU ARE MORE FUNCTIONAL, IT'S A
MATTER OF CHOICE, BUT AT THE
SAME TIME WE HAVE TO ACCOMMODATE
THEM BECAUSE THEIR NEEDS ARE NOW
DIFFERENT THAN THEY WERE
PREVIOUSLY.
I THINK IN THE HASTINGS CENTER
PAPER COMING OUT EARLY THIS YEAR
THE PRESERVATION, IT'S A
PERSONAL IDENTITY, RESTORED BY
THESE DEVICES IS THE ULTIMATE
ACCOMMODATION AND SHOULD BE
MANDATED UNDER DISABILITY LAW.
LET ME CLOSE BY SAYING THAT I'VE
BEEN DEEPLY INFORMED BITHIS
WONDERFUL BOOK BY HENRY
RICHARDSON, PHILOSOPHER, WHO
WROTE ABOUT ANCILLARY CARE
OBLIGATIONS IN MEDICAL RESEARCH.
HE WROTE MOSTLY ABOUT ANCILLARY
CARE OBLIGATIONS, CONTEXT OF
DOING, YOU KNOW, RESEARCH,
RESEARCH ABROAD, AND SAYING
DEPENDING ON LEVEL OF THE
ENGAGEMENT WITH THE COMMUNITY,
DEPENDENCE UPON YOU, DEPTH OF
THE RELATIONSHIP, ANCILLARY CARE
OBLIGATIONS BECOME MORE
ENTANGLEMENTS, ALMOST AN
OBLIGATION.
I WOULD SAY AS AN INVESTIGATOR
ON THE UH3 SIDE, AND IN THE
NEUROMODULATION SPACE, THIS
REALLY BECOMES THE CORE
COMMITMENT BECAUSE IDENTITY IS
CORE.
I REALLY THINK WE NEED TO THINK
ABOUT THESE RESPONSIBILITIES.
SO, TYING A LOT OF NIH GRANTS
TOGETHER WE HAVE UH3, AND GABE
OR JENNY MENTIONED EARLIER, NOW
AT HARVARD, HE AND I ARE MPIs
ON A NEW GRANT IN AUGUST LOOKING
AT THE QUESTION OF POST-TRIAL
OBLIGATIONS, AND SOME
PRELIMINARY IDEAS WHICH ARE
BEGINNING TO EMERGE, REALLY
PROVISIONAL IDEAS, THAT
RESPONSIBILITY FOR THE SUPPORT
OF THESE STAKEHOLDERS,
PARTICIPANTS, SHOULD BE SHARED
AMONGST FUNDERS, INVESTIGATORS,
INDUSTRY, AND THAT THE COST
SHOULD BE BUDGETED INTO THE
FUNDING OF CLINICAL TRIALS.
AND DBS PROTOCOL SHOULD BE
REQUIRED TO ARTICULATE SOME KIND
OF PLAN ABOUT MEETING POST-TRIAL
OBLIGATION AS CONDITION OF
APPROVAL BY INSTITUTIONAL REVIEW
BOARD.
WHAT WE'RE DOING OVER THE 3 1/2
YEARS LEFT, WE'RE INTERVIEWING
PARTICIPANTS IN A NUMBER OF
NEUROMODULATION TRIALS,
INTERVIEWING NEUROSURGEONS,
INDUSTRY FOLKS, AND FUNDERS,
WE'LL COLLECT INFORMATION AND
REACH CONSENSUS ABOUT REASONABLE
POLICY CHANGES THAT CAN MAYBE
ADDRESS CONCERNS.
THESE ARE SOME PROVISIONAL
IDEAS, NOT BY A LONG SHOT OUR
CONCLUSIONS.
ONE LAST POINT.
THE VERY FIRST SLIDE I SAID IN
TALKING TO THESE PARTICIPANTS IS
NOT JUST ABOUT PARTICIPATION AND
REPRESENTATION.
IT'S ALSO ABOUT SCIENCE.
AND IN A PAPER THAT WE WROTE
WITH THOMAS SHLEVER AND GERMAN
COLLEAGUES AND HELEN, KNOWN FOR
THE DEPRESSION TRIAL, BART
NEWTON, IN THE NETHERLANDS, WE
WROTE THIS PAPER IN BRAIN
STIMULATION WITH THE TITLE,
BEING OPENED MINDED ABOUT
NEUROMODULATION, FINDING SUCCESS
IN OUR FAILURES.
THE POINT WAS THAT A LOT OF
TIMES TRIALS HAVE SMALL
TRIALS -- SMALL TRIALS HAVE A
SMALL NUMBER OF PARTICIPANTS
HELPED AND NOT HELPED,
STIMULATION PARAMETERS ARE
LOCKED IN EARLY.
AT THE END OF THE TRIAL, I THINK
IT WAS SAID EARLIER, THESE
TRIALS ARE WAY TOO SHORT BECAUSE
BRAIN PLASTICITY TAKES A LONG
TIME.
WE CAN TALK ABOUT THAT.
HELEN MAYBERG'S LOOKED ARE
WORKED LOOKED PROMISED AT THE
BEGINNING, NOT IN THE MIDDLE,
BUT BUT FOLKS ARE DOING BETTER.
IF YOU WANT TO CONTINUE AND
THOUGHT HAD YOU BENEFIT IT'S NOT
JUST GOOD FOR THEM TO MAINTAIN
THEIR BATTERY AND ADHERE TO
POST-TRIAL OBLIGATIONS; THEY
ALSO CAN BE A GREAT OPPORTUNITY
TO LEARN MORE ABOUT THE NATURAL
HISTORY OF THESE CONDITIONS.
SO, IT'S REPRESENTATIVE AND
SCIENCE.
THIS IS A POINT WE MADE IN THE
MORE RECENT NIH GRANT, AND I
THINK THAT THERE ARE
OPPORTUNITIES FOR SYSTEM-BASED
LEARNING BY KEEPING CLOSE
CONNECTIONS WITH OUR
PARTICIPANTS.
THESE PIONEERS, AS SARAH AND
ERIN CALLED THEM.
LET ME CLOSE WITH A WONDERFUL
SLIDE FROM SPAIN.
THEIR MOTTO IS A LIFE THAT IS
SAVED DESERVES TO BE LIVED.
WE SPEND A LOT OF TIMES SAVING
LIVES.
NOW WE HAVE TO MAKE SURE FOLKS
CAN LIVE THESE LIVES.
THAT REALLY IS AT THE CORE OF
POST-TRIAL OBLIGATIONS.
I WANT TO THANK MY COLLEAGUES,
THE FAMILY WHO IS PARTICIPATED
IN OUR STUDIES AND I WILL STOP
THERE.
THANK YOU VERY MUCH.
>> THANK YOU.
LOOKING FORWARD TO DIVING INTO
THE DISCUSSION SAID TO
UNDERSTAND WHAT THE MEASURES OF
IDENTITY AND RESTORATION VERSUS
CHANGES TO SELF OVER TIME.
LET ME TURN NOW TO DR. ALEXANDER
HUTH, TO GIVE US A DIFFERENT
PERSPECTIVE ON A BIT OF HORIZON
SCANNING, ASSISTANT PROFESSOR,
UNIVERSITY OF TEXAS AUSTIN,
RESEARCH USES COMPUTATIONAL
METHODS TO MODEL HOW THE BRAIN
PROCESSES LANGUAGE AND
RECOMMENDS MEANING, Ph.D. FROM
UNIVERSITY OF CALIFORNIA
BERKELEY, B.S. AND M.S. FROM
CALIFORNIA INSTITUTE OF
TECHNOLOGY, A GOOD FRIEND TO
NEWG, HAVING SOME THIS SUMMER TO
GIVE PERSPECTIVES, ESPECIALLY
WITH A LOT OF EXCITING PAPERS.
THANK YOU FOR JOINING US.
>> THANK YOU.
I'M GOING TO TELL YOU ABOUT
SOMETHING DIFFERENT.
I'M GOING TO TALK ABOUT WHAT
KINDS OF INFORMATION WE CAN
MAYBE EXTRACT FROM THE KINDS OF
BRAIN SIGNALS WE MEASURE USING
STANDARD NEUROSCIENCE TECHNIQUES
LIKE fMRI.
SO, IN THE PAST FEW YEARS WE'VE
FOUND THAT USING fMRI WE CAN
SEE IN A GREAT DEAL OF DETAIL
REPRESENTATION OF MEANING OF
LANGUAGE AND OTHER KINDS OF
STIMULI ACROSS THE BRAIN.
THIS IS REALLY DRIVEN BY THREE
DIG DEVELOPMENTS IN THE FIELD.
ONE IS THIS METHOD OF VOXELIZING
CODING, TWO IS A REAL EXPLOSION
IN THE GROWTH OF METHODS FOR
COMPUTATIONALLY HANDLING TEXT,
SO METHODS FOR EXTRACTING WHAT
WE MIGHT CALL EXPRESSIONIVE
SEMANTICS FEATURES, GETTING
MACHINES, COMPUTERS TO
UNDERSTAND LANGUAGE IN A WAY
THAT CAN BE USEFUL TO US.
THREE IS BUILDING LARGE SCALE
fMRI DATASETS, WHERE WE HAVE
INDIVIDUAL SUBJECTS LISTEN TO A
LOT OF LANGUAGE SO WE CAN MAP
THINGS OUT IN DETAIL.
AND THIS GIVES US THE VERY HYPER
DETAILED SEMANTIC MAPS OF THE
BRAIN.
THIS IS ONE PARTICULAR VOXEL IN
MEDIAL FRONTAL CORTEX THAT MY
STUDENT SHELLY IDENTIFIED THAT
REALLY SEEMS TO LIKE IT WHENEVER
YOU HEAR A PHRASE THAT'S POLITE.
SO, THESE ARE THE PHRASES THIS
RESPONDS THE MOST TO.
THANK YOU, EXCUSE ME, I'M SORRY.
THIS IS THE REALLY DETAILED
INFORMATION WE CAN GET OUT OF
fMRI SCANS USING MODERN
COMPUTATIONAL DATASET
TECHNIQUES.
THIS HAS MADE IT POSSIBLE TO
DECODE A LOT OF INFORMATION FROM
THE BRAIN INTO LANGUAGE.
SO WE HAD STUDY LAST YEAR BY MY
STUDENT JERRY TANG, WE CAN USE
DETAILED MAPS TO RECONSTRUCT
LANGUAGE SOMEBODY IS HEARING OR
IMAGINING OR EVEN RECONSTRUCT
LANGUAGE FROM SOMETHING THAT
WASN'T LANGUAGE TO BEGIN WITH.
EXAMPLES, HERE IS A SNIPPET OF
LANGUAGE, I DIDN'T KNOW WHETHER
TO SCREAM, HELLER OR RUN AWAY.
THE DECODED VERSION WAS STARTED
TO SCREAM AND CRY AND SHE JUST
SAID I TOLD YOU TO LEAVE ME
ALONE, YOU CAN'T HURT ME.
IT'S NOT PERFECT BUT IT'S PRETTY
SHOCKINGLY GOOD FOR USING
fMRI.
THIS ALSO APPLIES TO IMAGINED
SPEECH.
AN EXAMPLE OF A PERSON NOT
LISTENING TO A STORY BUT
IMAGINING TELLING THE STORY IN
THEIR HEAD.
LOOKED FOR A MESSAGE FROM MY
WIFE.
THE DECODED VERSION, I THOUGHT
SHE WOULD COME AND SAY SHE
MISSES ME.
LESS ACCURATE BUT STILL WORKS
REMARKABLY WELL.
AND WE CAN SHOW SOMEBODY A
SILENT VIDEO AND PLUG THIS DATA
INTO THIS DECODER AND READ OUT
WORDS THAT DESCRIBE WHAT'S
HAPPENING IN THE VIDEO QUITE
ACCURATELY.
WHAT THE DECODER SPITS OUT, SHE
HELD MY HAND TO HER LIPS AND
SMILED.
THIS WAS EXCITING.
WE CAN BUILD THESE MODELS,
EXTRACT INFORMATION FROM
SEMANTIC REPRESENTATIONS IN THE
BRAIN BUT THIS RAISES BOTH SOME
EXCITING POSSIBILITIES, THIS
COULD BE A BENEFIT FOR PEOPLE
WITH COMMUNICATION DISORDERS,
WE'RE INTERESTED IN TRYING TO
USE THIS TECHNOLOGY TO HELP
PEOPLE WITH APHASIA, INVASIVE
RECORDINGS ARE NOT APPROPRIATE.
BUT THIS ALSO RAISES
POSSIBILITIES THAT fMRI CAN
EXTRACT PRIVATE INFORMATION THAT
PEOPLE DON'T WANT TO SHARE AND
MAYBE EVEN FROM EXISTING PUBLIC
fMRI DATA.
THERE'S A LOT OF DATA SHARED IN
THE WORLD.
SO, THESE ARE SOME
POSSIBILITIES.
I'LL TALK ABOUT WHY WE MAYBE
SHOULDN'T BE WORRIED OR SHOULD
BE WORRIED ABOUT THESE THINGS.
SO, LIMITATIONS.
THE TECHNOLOGY AS WE CURRENTLY
HAVE IT HAS SOME PRETTY SEVERE
LIMITATIONS THAT MAKE THESE
WORRIES MAYBE LESS WORRYING.
CURRENTLY IT REQUIRES VERY
L ARGE fMRI TRAINING SETS, 16
HOURS FOR EACH USER IN THE DATA
I SHOWED YOU.
THE PERSON HAS TO GO BACK IN THE
SCANNER OVER AND OVER AGAIN.
YOU CAN'T REALLY DO THAT WITHOUT
SOMEONE'S CONSENT AND WILLING
PARTICIPATION.
THIS IS A VERY DIFFICULT THING
TO GET THAT MUCH DATA ON
SOMEONE.
MODELS HAVE TO BE TRAINED ON
LANGUAGE PERCEPTION DATA O
SOMEBODY LISTENING TO STORIES,
TO LANGUAGE, WHICH HAS ACTUALLY
DOWN SIDES FOR THERAPEUTIC
POTENTIAL OR CLINICAL POTENTIAL
ALSO BECAUSE THAT MEANS IF
SOMEBODY HAS SEVERE APHAGIA
WHERE THEY HAVE TROUBLE
UNDERSTANDING LANGUAGE AS WELL
AS SPEAKING OUR MAPPING
TECHNIQUE MIGHT NOT WORK WELL.
IT HAS LIMITED ACCURACY.
I SHOWED SOME REASONABLE GOOD
EXAMPLES.
IT'S NOT ALWAYS THIS GREAT.
THERE'S A LONG WAY TO GO.
THE QUESTION, ARE THESE
LIMITATIONS FUNDAMENTAL?
DO WE ALWAYS NEED A LARGE
TRAINING SAID, TO TRAIN ON
LANGUAGE DATA?
AND HOW LIMITED IN ACCURACY ARE
WE GOING TO BE?
LET'S TALK ABOUT AVOIDING MODEL
TRAINING, HOW CAN WE GET AROUND
THIS?
CAN WE APPLY TO NEW PEOPLE
WITHOUT THIS TRAINING DATA?
WE CAN ANATOMICALLY REGISTER
BRAINS, THAT DOES NOT WORK.
THERE'S FUNCTIONAL
CO-REGISTRATION METHODS THAT
SEEM PROMISING AND MAKE THIS
WORRYING.
THE WAY OUR TYPICAL
WITHIN-PARTICIPANT MODEL WORKS,
YOU CLICK THE BIG TRAINING
DATASETS FROM ONE PARTICIPANT,
BUILD A MODEL OF HOW BRAIN
PROCESSES REPRESENTATIVE
INFORMATION, YOU GET NEW DATA,
TEST DATA, USE YOUR MODEL TO
DECODE AND GET A RESULT.
LOU CAN WE CROSS THE STREAMS
WITH MULTIPLE PARTICIPANTS?
WE'RE GOING TO SAY WE HAVE
PARTICIPANT 1, WE COLLECT
TRAINING DATA AND BUILD OUR
MODEL.
IN ADDITION WE ALSO COLLECT THIS
SMALL DATASET, CONVERTER
TRAINING DATASET.
NOW, WHAT IS IN THIS DATASET,
I'LL TALK ABOUT IN A MOMENT.
IT CAN BE MUCH SMALLER THAN
TRAINING DATASET.
SECOND PARTICIPANT WE ONLY
COLLECT THE SMALL CONVERTER
TRAINING DATASET AND THE TEST
DATA WE WANT TO DECODE.
SOME TASK WE WANT TO SEE.
THEN WE'RE GOING TO USE
CONVERTER TRAINING DATASETS TO
TRAINING THIS MODEL TO TAKE DATA
FROM THE SECOND AND MAKE IT LOOK
LIKE IT'S FROM THE FIRST ONE.
WE CALL THIS MAYBE A P2 TO 1
CONVERTER, TRANSFORMS IT INTO
PARTICIPANT 1'S BRAIN, IT TURNS
OUT YOU CAN DO THIS WITH SMALL
DATASETS.
WHICH WAS SURPRISING TO US.
ONCE WE HAVE THIS MODEL WE CAN
APPLY TO THE TEST DATA, WE GET
CONVERTED TEST DATA, LOOKS LIKE
IT'S IN PARTICIPANT 1'S BRAIN,
IT CAME FROM PARTICIPANT 2 AND
WE CAN USE THAT TO GET OUR
RESULT, ORIGINALLY DEVELOPED FOR
DOING VISUAL DECODING BUT WE'VE
APPLIED IT HERE, IT WORKS WELL,
A PAPER STILL IN PROGRESS.
WHEN WE DO CONVERTER BASED
APPROACH IT WORKS BETTER FOR
SMALL DATASETS THAN ACTUALLY
BUILDING THE MODEL LIKE WITHIN
THE SUBJECT.
THIS IS SHOWING HOW WELL WE CAN
DECODE AND HOW MUCH DATA WE HAVE
FROM THE PARTICIPANT WE'RE
TRYING TO DECODE FROM, THE GRAY
DOTS SHOW IF WE'RE TRAINING A
MODEL UP TO 256 MINUTES, BLUE
DOTS SHOWING CONVERTER MODEL,
TAKING DATA.
YOU CAN SEE SMALL AMOUNTS OF
DATA, 15 MINUTES TO TWO HOURS,
THE CONVERTER WORKS BETTER THAN
TRAINING MODEL WITHIN SUBJECT,
THIS IS STILL A FAR CRY AWAY
FROM WHAT THE FULL DATASET, 19
SIGMA UP HERE, BUT WE'RE HOPEFUL
THAT WE HAVE NOT HIT THE CEILING
HERE AND THERE'S A LOT MORE TO
BE DONE.
THIS IS STILL USING LANGUAGE
DATA, AND IT TURNS OUT THE
CONCERTER DOESN'T HAVE TO BE
TRAINED ON LANGUAGE.
WE TESTED VISUAL STIMULI,
PARTICIPANTS WATCHED A BUNCH OF
PIXAR SHORT FILMS, LIKE THESE.
THEY ARE FUN.
THEY ARE GREAT.
THEY DON'T HAVE ANY LANGUAGE.
THEY ARE FULLY ACTED OUT.
WE SHOWED WITH NO SOUND ALSO.
THIS IS SHOWING HOW WELL WE CAN
DECODE IN A PARTICIPANT, HAVING
JUST THIS MOVIE DATA FROM THEM.
WE HAVE NO LANGUAGE TRAINING
DATA WHATSOEVER FROM A
PARTICIPANT, AND THIS GOES OUT
TO 256 MINUTES, THIS GOES TO 64,
AND EQUIVALENT PERFORMANCE
THERE.
THIS IS TRYING TO TRAIN LANGUAGE
DECODER ON MOVIE DATA, THAT'S
DIFFICULT TO DO.
SO, TOGETHER THIS SHOWS THAT
THESE CAN DECODE BY LEVERING
EXISTING DECODERS, CAN USE A
DIFFERENT MODALITY, VISION FROM
LANGUAGE, WE COULD BUILD A
CONVERTER WITHOUT TRAINING DATA
WITH STIMULUS, POSSIBLE EVEN
WITH RESTING STATE DATA.
THIS IS A BIG QUESTION THAT
OPENS UP THE IDEA THESE KINDS OF
DECODING APPROACHES COULD APPLY
TO MORE DATA.
THE LAST PART IMPROVING
ACCURACY, CAN WE MAKE THEM
BETTER, ARE THEY LIMITED BY
TECHNOLOGY WE USE?
THE CURRENT DECODER USES OLD
NEURAL NETWORK LANGUAGE MODEL,
NOW WE'RE UP TO GPT 4, NOT
PUBLICLY ACCESSIBLE, A SINGLEN
CODING MODEL, ONE MODEL FOR ONE
SUBJECT, BUT WE CAN USE BIGGER
LANGUAGE MODELS SO NOWADAYS THE
BIGGEST ONE AVAILABLE PUBLICLY
IS THIS LLAMA2 MODEL FROM META.
WE CAN USE MODEL ENSEMBLING
TECHNIQUES, MULTIPLE MODELS FOR
ONE SUBJECT AND JOIN TOGETHER.
WE CAN BOOST PERFORMANCE USING
COMPUTATIONAL TECHNIQUES,
SHOWING AGAIN THIS SIMILARITY
METRICS ON THE Y-AXIS, BASELINE
GPT-1 MODEL, UPGRADING TO
LLAMA2 A BOOSTER, ADDING
ENSEMBLING A MASSIVE BOOST,
BETTER BY ADDING COMPUTATION TO
THIS MIX, DOING MORE COMPUTE.
HERE'S AN EXAMPLE, WHAT THE
PERSON HEARD WAS HE TAKES A DRAG
OF THE CIGARETTE, A HARD, HARD,
DRAG, HOT, HOT, HOT.
GPT VERSION GETS A GIST, A BUZZ
OFF THE WAY IT MADE MY BLOOD
PUMP HARD AND FAST TO CONTROL IT
HURT, LIKE EMOTIONAL VALENCE BUT
NOT THE CONTENT, THIS NEW
DECODER SAID SHE TOOK A HIT OFF
THE JOINT, IT BURNT UP HER
THROAT FELT LIKE SHE WAS SUCKING
IT OUT.
STILL INACCURATE, CIGARETTE
TURNED INTO JOINT, BUT GETTING
BETTER AND WE HAVEN'T HIT THE
LIMITS YET.
WHAT'S HAPPENING WITH
IMPROVEMENT IT'S WE'RE TRADING
COMPUTE FOR BUDGET, USE MORE
COMPUTER TIME, BIGGER COMPUTERS,
WE GET MORE ACCURATE DECODING
AND THAT WORKS QUITE WELL.
THIS IS WORK BY MY STUDENT R J
ANTONELLO.
THAT'S WHAT I WANTED TO TALK
ABOUT TODAY.
TO RECAP, WE'VE SEEN LIMITATIONS
ON WHAT YOU CAN DECODE FROM
fMRI.
WE NEED LARGE DATASETS.
IT HASN'T FULLY REACHED THE SAME
PERFORMANCE BUT IT'S REMARKABLE
WHAT WE CAN DO WITH ALMOST NO
TRAINING DATA FROM A PERSON EVEN
IN A DIFFERENT MODALITY NOW.
WE HAVE THIS LIMITED ACCURACY
BUT THAT WE'RE SEEING THIS
COMPUTE SCALING, THROW BIGGER
COMPUTERS AT THE PROBLEM AND
WITH CLEVER TWEAKS GET
PERFORMANCE OUT.
I DON'T THINK THERE'S ANY SENSE
THAT COMPUTE SCALING IS GOING TO
SLOW DOWN IN THE FUTURE
ESPECIALLY WITH THE WAY A.I.
THINGS ARE GOING.
WE'LL ONLY SEE MORE INCREASES
HERE.
THAT'S WHAT I WANTED TO TALK
ABOUT.
I THANK THE PEOPLE WHO DID THIS
WORK, GRAD STUDENTS IN MY LAB,
ONE NOW A POSTDOC, FUNDING FROM
NIDCD AND OTHER SOURCES.
THANK YOU FOR INVITING ME.
>> THANK YOU, DR. HUTH.
EXCITING WORK, CERTAINLY PUSHES
US TO THINK HARD.
I'LL BE CURIOUS WHEN WE GET TO
THE Q&A SESSION IF ANY OF THE
CONVERTER WORK, MENTAL PRIVACY
WORK IN PRIOR PAPER IN APRIL,
CHANGES YOUR VIEWS ON SOME OF
THE THINGS THAT YOU SAID THERE.
BUT WE'LL CATCH THAT IN THE Q&A
WHICH IS COMING UP SOON.
LET'S TURN TO OUR FINAL
PRESENTATION FOR THIS PANEL, DR.
McINTOSH, AN ASSISTANT
PROFESSOR OF MEDICINE, BIOETHICS
RESEARCH CENTER, WASHINGTON
UNIVERSITY SCHOOL OF MEDICINE,
MASTER'S AND Ph.D. IN
INDUSTRIAL ORGANIZATIONAL
PSYCHOLOGY UNIVERSITY OF
OKLAHOMA WITH SPECIALIZATION IN
ETHICAL DECISION MAKING,
INNOVATION AND LEADERSHIP.
CURRENTLY LEADS FEDERALLY FUNDED
AND FOUNDATION FUNDED RESEARCH
ON ETHICAL AND SOCIAL ISSUES IN
SCIENCED A MEDICINE.
NEUROETHICS-SPECIFIC WORK
IDENTIFIES CHALLENGES FOR
NAVIGATING INDUSTRY, ACADEMIC
PARTNERSHIPS, AND RESEARCH AND
COMMERCIALIZATION OF
NEUROTECHNOLOGIES.
THANK YOU FOR JOINING US.
WE'RE LOOKING FORWARD TO YOUR
COMMENTS.
>> THANKS YOU FOR HAVING ME.
LET ME SHARE MY SCREEN.
YEAH, I'M THRILLED TO TALK WITH
YOU ABOUT SOME OF THE WORK MY
TEAM AND I HAVE BEEN WORKING ON.
I APPLY TRAINING AS
ORGANIZATIONAL PSYCHOLOGIST TO
STUDY ETHICAL AND PROFESSIONAL
ISSUES IN SCIENCE AND MEDICINE,
BREAD AND BUTTER IN CONDUCT OF
RESEARCH BROADLY, HOW TO CREATE
SUPPORTIVE AND HEALTHY WORKPLACE
ENVIRONMENTS THAT SUPPORT
QUALITY RESEARCH AND I'VE GOTTEN
INTO NEUROETHICS IN THE PAST FEW
YEARS.
I HAVE AN R01 ON EXPLORING THIS
ISSUE HOW TO CULTIVATE
RESPONSIBLE PARTNERSHIPS BETWEEN
ACADEMIA AND INDUSTRY, RESEARCH
AND COMMERCIALIZATION OF NEURAL
TECHNOLOGIES.
I'LL TALK ABOUT RATIONALE AND
KEY CONSIDERATIONS DRIVING THIS
WORK, PRELIMINARY FINDINGS FROM
A COUPLE STAKEHOLDER GROUPS AS
PART OF THIS PROJECT.
IN PARTICULAR I'M GOING TO TALK
ABOUT FACTORS THAT INFLUENCE
DECISIONS AND PRIORITIES AND HOW
WE MIGHT WANT TO BE MORE
INTENTIONAL IN TRADEOFFS MADE IN
THIS SPACE.
NEUROTECHNOLOGYISTS HAVE A
GROWING CAPACITY TO IDENTIFY AND
PREVENT AND TREAT A RANGE OF
CONDITIONS.
THERE'S A LOT, A SIGNIFICANT
AMOUNT AND QUALITY OF RESOURCES
AND RANGE OF EXPERTISE NEEDED TO
DEVELOP AND SCALE
NEUROTECHNOLOGIES IN A WAY THAT
BENEFITS THE PUBLIC.
YOU WANT IT TO BENEFIT PEOPLE
IT'S INTENDED TO BENEFIT.
INDUSTRY ACADEMIA PARTNERSHIPS
ARE A COMMON MECHANISM FOR
MAKING THAT HAPPEN.
EACH ENTITY SERVES A DIFFERENT
PURPOSE IN BRAINS, UNIQUE
STRENGTHS AND RESOURCES TO THE
PAPER.
IN ACADEMIA PEOPLE WITH
EXPERTISE ARE NEEDED FOR
FOUNDATIONAL WORK FOR
TECHNOLOGIES.
INDUSTRY, ON THE OTHER HAND, HAS
THE CONNECTIONS AND RESOURCES
UNIVERSITIES DON'T NECESSARILY
HAVE TO BRING THAT TECHNOLOGY TO
MARKET.
FEDERAL LEGISLATION ALLOWS
ACADEMIC INSTITUTIONS TO RETAIN
OWNERSHIP RIGHTS OF FEDERALLY
FUNDED INNOVATION.
YOU CAN SEE IN THE GRAPHIC A LOT
OF STAKEHOLDERS HAVE A VESTED
INTEREST IN NOT ONLY PROCESS OF
RESEARCH AND COMMERCIALIZATION
BUT OUTCOMES OF THE PROCESS,
RANGING FROM INDUSTRY, YOU HAVE
SMALL START-UP COMPANIES MERGING
OUT OF ACADEMIC SETTINGS, REALLY
LARGE ESTABLISHED COMPANIES THAT
OFTEN HAVE THAT MORE TOP-DOWN
APPROACH.
WITHIN THE ACADEMIC SETTING IT'S
NOT HOE HOMOGENOUS.
HAVE YOU INSTITUTION OFFICIALS
ON THE REGULATORY SIDE OF
THINGS, MORE RISK CONSCIOUS, AND
THE OTHER SIDE PARTNERSHIP
CULTIVATION INSTITUTIONAL
OFFICIALS, TO ADAPT MORE OF THE
ENTREPRENEURIAL AND INNOVATION
TYPE OF MINDSET AND GOAL.
SEW THEY HAVE NOT NECESSARILY
CONFLICTING ROLES WITHIN
ACADEMIC SETTINGS BUT THEY SERVE
DIFFERENT PURPOSES.
YOU HAVE SCIENTISTS, SURGEONS,
PEOPLE IN GOVERNMENT, THE LIST
GOING ON.
THERE'S AREAS OF OVERLAP IN
PRIORITIES AND VALUES AMONG
DIFFERENT GROUPS BUT THEY ARE
STRONG PRIORITIES AND VALUES,
OCCURS BETWEEN AND WITHIN
INDUSTRY AND ACADEMIA, EVEN
WITHIN INDUSTRY AND ACADEMIC
SETTINGS, LIKE I TALKED ABOUT.
THIS REPRESENTS THAT BALANCE
BETWEEN SCIENTIFIC PRINCIPLES
AND GOALS THAT MANY PEOPLE
SHARE, AND COMMERCIAL INTERESTS,
NEUROTECHNOLOGY, ON THE
LEFT-HAND SIDE YOU HAVE SOME
SCIENTIFIC VALUES THAT MOST
PEOPLE VIEW AS INTENDING TO
UPHOLD INTEGRITY, THE WAY THE
DATA ARE COLLECTED AND REPORTED,
HONESTY, OPENNESS,
ACCOUNTABILITY, FAIRNESS,
STEWARDSHIP.
WE ACKNOWLEDGE COMMERCIAL
PRIORITIES AND PRESSURES, OFTEN
TIED TO PROFITABILITY AND
MAINTAINING MARKET SHARE, THEY
HAVE A FIDUCIARY DUTY, YOU CAN
START TO SEE HOW THERE'S TENSION
THERE.
I WANT CLEAR I'M NOT SAYING
INDUSTRY HAS NO INTEREST IN
SCIENTIFIC PRIORITIES.
I THINK THEY DO.
I WAS REFRESHING MY MEMORY OF A
STUDY OF INDICATE MCDUFFEY --
KATE MCDUFFEY, ASKING ABOUT
ETHICAL PRIORITIES IN RESEARCH.
THE LONG AND SHORT WAS THEY DO
HAVE THIS VESTED INTEREST IN
BEING ABLE TO UPHOLD SCIENTIFIC
PRIORITIES, WHILE HAVING TO
CONTEND WITH COMMERCIAL
PRIORITIES BUT THE REALITY WE
HAVE LIVE AND WORK IN A
CAPITALISTIC ECONOMIC SYSTEM
WITH STRONG FINANCIAL INTERESTS.
THERE'S NON-FINANCIAL FACTORS.
I LIKE TO CALL IT PRESTIGE
FACTOR.
THERE'S PRESSURE TO BE A
TRAILBLAZER IN THIS SPACE, FIRST
IN HUMAN TRIALS, ALSO MOVE FAST
AND BREAK THINGS ETHOS
ESPECIALLY IN START-UP SPACES
INCLUDING MORE DISRUPTIVE
DOMAINS, A GAP BETWEEN THE GOAL
AND BALANCES OF COMMERCIAL AND
SCIENTIFIC PRODUCTS.
WHAT HAPPENS IN PRACTICE, RIGHT?
THERE'S A GAP THERE.
I'M STARTLING TO BRIDGE THAT
GAP, THE QUESTION OF HEY, HOW DO
YOU GO ABOUT BALANCING THE
COMPLEX AND SOMETIMES COMPETING
INTERESTS AND HOW YOU GET
EXPERTS FROM THE DIFFERENT
CULTURES TO WORK TOGETHER AND
CARRY OUT WORK AND HOLD THOSE
DIFFERENT ENTITIES ACCOUNTABLE.
IT'S A COMPLEX NETWORK THAT HAS
AN IMPACT ON DECISIONS AND
PRIDES MADE ABOUT THE WAY
NEUROTECHNOLOGY RESEARCH IS
DONE, THAT'S MORE COMPLICATED
BECAUSE INFLUENCING FACTORS CAN
OPERATE BELOW OUR THRESHOLD OF
DETECTION, SOMETIMES THAT
INFLUENCE IS NOT BAD, OTHER
TIMES NOT GREAT, LIKE AN
UNCONSCIOUS BIAS.
IT'S A NORMAL PART OF BEING A
HUMAN BEING, RIGHT?
BUT IT DOES POSE A RISK TO
RESEARCH AND SCIENTIFIC
PRINCIPLES, THIS HAPPENS DESPITE
GOOD INTENTIONS.
PEOPLE SAY WE WANT TO DO THE
RIGHT THING, OF COURSE WE'LL DO
THE RIGHT THING.
AND I THINK THAT'S THE CASE THAT
THE VAST MAJORITY OF PEOPLE IN
THE SPACE ARE HERE TO DEVELOP
TECHNOLOGIES THAT BENEFIT
OTHERS, BENEFIT THE PUBLIC.
SO THAT'S WHY YOU NEED TO BE
INTENTIONAL ABOUT TRADEOFFS
WE'RE WILLING TO MAKE, OUTCOMES
WE WANT TO PRIORITIZE BECAUSE WE
CAN'T HAVE OUR CAKE AND EAT IT
TOO.
WE'RE TRYING TO DISENTANGLE
COMPLEXITIES, BE PRO-ACTIVE IN
BRINGING GROUPS TOGETHER TO
THINK HOW DO WE WANT TO NAVIGATE
PROCEEDINGS.
I WANT TO GIVE AN OVERVIEW OF
THE RESEARCH STREAM I HAVE GOING
ON, BIRDSEYE VIEW OF AIMS AND A
DEEP DIVE INTO THE FIRST AIM
SPECIFICALLY WITH THE FIRST TWO
GROUPS.
THE FIRST AIM WE'RE DOING
IN-DEPTH INTERVIEWS WITH SEVEN
NEUROTECHNOLOGY STAKEHOLDER
GROUPS TO IDENTIFY RISK
FACTORINGS AND ETHICAL
CHALLENGES AND BRAINSTORMING
SOLUTIONS.
AT THE TOP WE HAVE THE TWO
CLUSTERS OF INSTITUTIONAL
OFFICIALS, WE HAVE PARTNERSHIP
CULTIVATION FOLKS, TECHNOLOGY
TRANSFER, OFFICE OF TEXT
MANAGEMENT.
SECOND HAVE YOU REGULATORY AND
COMPLIANCE OFFICIALS SO I'LL GET
BACK TO THOSE BUT WE'VE ALSO
INTERVIEWED NEUROETHICISTS, TO
ENGAGE WITH PEOPLE WHO DO THIS,
TALKING ABOUT RESEARCHERS,
PHYSICIANS AND SURGEONS,
INDUSTRY PARTNERS, SO WE'RE
ROUNDING OUT THIS AIM RIGHT NOW
AND ARE WORKING ON GETTING SOME
DATA PUBLISHED.
TO TAKE YOU THROUGH AND
LONG-TERM PLAN OF THE AGENDA,
THE SECOND AIM, BRING IN
STAKEHOLDER GROUPS TO DEVELOP
CONSENSUS ON PROMISES PRACTICES
FOR MITIGATING RISK AND TOOLKIT
THAT'S GOING TO PROVIDE GUIDANCE
FOR PEOPLE TO ETHICALLY
NAVIGATE, SOME GUIDANCE TAILORED
FOR CERTAIN GROUPS, OTHERS WILL
BE MORE GENERAL AND I THINK IT
WILL PROBABLY BE THE CASE WE'LL
BE ABLE TO REACH CONSENSUS ON
SOME THINGS AND NOT OTHERS,
INTERESTING TO SEE HOW THIS
SHAPES OUT.
GOING BACK TO THE FIRST AIM, TO
TALK ABOUT INTERVIEWS WITH
INSTITUTIONAL OFFICIALS, I KNOW
WE ONLY HAVE A COUPLE MINUTES
LEFT.
I WANT TO GIVE A BIRDSEYE VIEW
OF CATEGORIES OF QUESTIONS WE'RE
ASKING FOLKS.
WE STRUCTURED TO HELP TO ASK
ABOUT POLICY AND REGULATORY
CONSIDERATIONS, WHAT WORKS, WHAT
ISN'T WORKING, WAYS TO GIVE A
FACE LIFT TO TAKE INTO ACCOUNT
THESE NUANCES, ESPECIALLY WITH
NEUROTECHNOLOGY,
COMMERCIALIZATION, WHAT MIGHT
NEED TO BE DONE IN THE FUTURE.
WE ROUND THINGS OUT ASKING ABOUT
CONTENT THAT SHOULD GO INTO THE
COOL AT THIS TIME, ADVICE FOR
OTHER STAKEHOLDERS.
ONE THING I'M REALIZING PEOPLE
OPERATE IN A SILO, DIFFERENT
ASSUMPTIONS, NOT COMMUNICATING
WITH ONE ANOTHER SO ADVICE IS
CRITICAL MOVING THE FIELD
FORWARD.
ON THE RIGHT-HAND SIDE YOU SEE
DIFFERENT SAMPLE QUESTIONS, WHAT
ARE STRATEGIES TO ADDRESS THESE
ISSUES AND WHAT GAPS OR
LIMITATIONS ARE THERE.
I'M GOING TO DO ON A LIGHTNING
ROUND, PRESENTING MORE IN DETAIL
AT THE INS MEETING, IF YOU WANT
TO CHECK THAT OUT.
INSTITUTIONAL OFFICIALS, A LOT
TALK ABOUT PATIENT SAFETY AND
NEEDING TO BALANCE WITH GOALS OF
INNOVATION AND TRANSPARENCY.
SOMETIMES EASIER SAID AND DONE.
THE FIRST REGULATORY
INSTITUTIONAL OFFICIAL QUOTE,
SAFEGUARD PERSONAL INFORMATION,
DATA SHARING, IF YOU CAN GET THE
COMPANY TO AGREE TO ALLOW YOU TO
PUBLISH DATA, OPEN DATABASES,
BENEFICIAL TO PUT THAT OUT AND
GET THOSE DATASETS TOGETHER.
SECOND QUOTE FROM CULTIVATION
INSTITUTIONAL WAS INTERESTING.
EXPRESSED CONCERNS ABOUT NOT
OVERMANAGING, SAY, HUMANS, GUT
REACT TO PROTECT PEOPLE, BUT YOU
NEED TO TRUST LISTENING TO ALL
INFORMATION WE RECEIVED, CONSENT
PROCESS, MAKING AN EDUCATED
DECISION.
I THOUGHT IT WAS SO INTERESTING.
IF YOU'RE PLUGGED IN, YOU KNOW
THAT'S NOT ALWAYS THE CASE.
PEOPLE DON'T ALWAYS FULLY
UNDERSTAND THE SCOPE OF RISKS
AND BENEFITS.
YOU CAN SEE THE JUXTAPOSITION,
HOW THEY ARE SAYING HEY,
EVERYTHING IS FINE, WE DON'T
NEED TO MAKE BIG CHANGES HERE.
I THINK THAT GETTING DIFFERENT
ENTITIES AND STAKEHOLDER GROUPS
TO COMMUNICATE MORE EXPLICITLY
AND EARLY ON WILL HELP PREVENT
ASSUMPTIONS FROM BEING MADE.
ANOTHER THEME THAT EMERGED WITH
INSTITUTIONAL OFFICIALS, WITH
BOTH GROUPS, PRIOR TO ENTERING
INTO PARTNERSHIP UNIVERSITIES
ARE REALLY KEEN ON MAKING SURE
THERE'S AT LEAST SOME SHADER
OVERLAP IN VALUES AND GOALS
BETWEEN INSTITUTION AND THAT
PERSPECTIVE, INDUSTRY PARTNER,
AND THEY ILLUSTRATED THE TRUST
AND OPEN COMMUNICATION AMONG ALL
PARTIES MATTER, NOT ONLY OPEN
COMMUNICATION AT THE OUTSET AND
ESTABLISHMENT OF THAT
RELATIONSHIP BUT REVISITING
CONVERSATIONS THROUGHOUT AND
BECAUSE RESEARCH IS NOT STATIC
THINGS CHANGE, PARAMETERS
CHANGE, BEING ABLE TO HAVE THAT
FLEXIBILITY AND COMMUNICATION,
BEING ABLE TO PIVOT AS THINGS
COME TO LIGHT IS CRITICAL FOR
THESE PARTNERSHIPS.
WE DON'T WANT TO PARTNER WITH
SOMEONE THAT'S PATENT TROLL, WE
VET TO MAKE SURE GOALS ALIGN
WITH GOALS OF THE UNIVERSITY.
IN CONVERSATIONS SOMETIMES
THAT'S EASIER SAID THAN DONE,
THOSE NEGOTIATIONS CAN BE
TRICKY.
INTELLECTUAL PROPERTY WAS A HOT
TOPIC, BOTH INDUSTRY AND
ACADEMICA WANT TO RETAIN I.P.
RIGHTS.
IT'S ESPECIALLY DIFFICULT TO
DETERMINE THIS WHEN DEVICE IS
FROM MULTIPLE FUNDING SOURCES.
IT GETS COMPLICATED.
YOU CAN SEE FROM THIS
INSTITUTIONAL OFFICIAL, HEY, THE
COMPANIES WANT TO OWN EVERYTHING
OR NEGOTIATE BEFORE ANYTHING IS
DEVELOPED, YOU CAN SEE HOW THAT
GETS TRICKY.
I.P. ISN'T ALWAYS CLEAN
ESPECIALLY WITH MULTIPLE FUNDING
SOURCES.
THERE'S A LOT OF NUANCE THAT I
THINK PEOPLE NEED TO BECOME MORE
AWARE OF AND NAVIGATE.
DATA SHAKER IS -- DATA SHARING
IS ALSO LINKED, PROTECTING
PRIVACY AND CONFIDENTIALITY,
MAKING SURE CONTRACTS AND
INFORMED CONSENT DOCUMENTS
SPECIFY HOW DATA WILL BE USED
AND BY WHOM, THAT OPENS A CAN OF
FORMS, WHAT IF TOOLS IMPROVE BUT
WE DON'T KNOW AT THE TIME OF
COLLECTING THE DATA, HOW DO WE
ENSURE THAT THAT'S BEING
NAVIGATED APPROPRIATELY.
I WANTED TO SHARE THIS QUOTE
FROM THE OFFICIAL.
ALL THE PATIENT DATA, THE
COMPANY WANTS THAT AS PART OF
THE LICENSE, THAT COULD BE A
DEAL BREAKER IF NOT ACCURATELY
CONSENTED AND APPROVED SO BEING
ABLE TO HAVE CONVERSATIONS EARLY
ON AND THROUGHOUT THAT
PARTNERSHIP IS IMPORTANT.
RISK MANAGEMENT AND LIABILITY IS
ANOTHER TOPIC THAT CAME UP.
UNIVERSITIES ARE VERY RISK
AVERSE, TALKING WITH REGULATORY
OFFICIALS BIG ON EMPHASIZING
CONTRACTS NEED TO IMPROVE PLANS,
WHO IS ON THE HOOK FOR ADVERSE
EVENTS, LONG-TERM CARE OF
PARTICIPANTS, WE TALKED ABOUT
EARLIER, POST-TRIAL ACCESS AND
RESPONSIBILITIES, AND
COMPLICATED TOPIC TO NAVIGATE.
ROUNDING THINGS OUT THEY
MENTIONED CONFLICTS OF INTEREST
QUITE A BIT.
INDIVIDUAL RESEARCH CONFLICTS OF
INTEREST, THE WAYS THEY ARE
MANAGED, NOT A NOVEL FINDING.
PERHAPS MORE INTERESTINGLY IS
THE REGULATORY GROUP BROUGHT UP
THE IDEA OF INSTITUTIONAL
CONFLICT OF INTEREST, ACADEMIC
INSTITUTIONS NEED TO CONTENT
WITH FINANCIAL AND NON-FINANCIAL
CONFLICTS OF INTEREST,
IMPLICATIONS FOR THE
UNIVERSITY'S REPUTATION.
REGULATORY OFFICIAL, HEY, IN
TERMS OF COMING UP NEW
REGULATION, MAYBE IT SHOULD BE
ON INSTITUTIONAL CONFLICTS
INTEREST, CLEAR PATH ABOUT
WHAT'S TO BE DONE, LOOKING FOR
ACTUAL GOVERNMENT POSITION ON
IT.
I THINK A LOT OF ACADEMIC
INSTITUTIONS ARE TRYING TO
BENCHMARK.
HEY, WHAT ARE YOU DOING, NO
UNIFORM STANDARDS HOW TO
NAVIGATE GOES.
AND THE LAST QUOTE, THEY TALK
ABOUT RISK PERCEPTION, HOW
THINGS ARE PERCEIVED IN THE "NEW
YORK TIMES," A FAMILY WANTS TO
SUE BUT AN INSTITUTION HAS AN
INTEREST WITH THE COMPANY, THAT
COULD HAVE INTERESTING
IMPLICATIONS FOR THE
INSTITUTION.
THESE ARE SOME VERY PRELIMINARY
HIGHLIGHT FINDINGS, CURIOUS TO
GET REACTION FROM THE GROUP.
IT'S CLEAR THESE ENTITIES NEED
TO UNDERSTAND EACH OTHER BETTER
AND WORK TO RECONCILE DIFFERENT
CULTURES AND PRIORITIES BECAUSE
THAT SHAPES HOW SCIENTIFIC WORK
GETS DONE.
TO ALSO ESTABLISH RELATIONSHIPS
THAT ARE MUTUALLY BENEFICIAL,
EACH OF THESE ENTITIES HAS
SOMETHING IMPORTANT TO BRING TO
THE TABLE AND BEING ABLE TO HAVE
CONVERSATIONS RELATED TO I.P.
AND DATA TRANSPARENCY AND
RELATED MATTERS, THINGS NEED TO
HAPPEN EARLY AND OFTEN.
SO THAT IS THE LONG AND SHORT OF
IT.
THANK YOU TO MY WONDERFUL TEAM.
PROJECT ADVISORY BOARD, THE
BRAIN INITIATIVE FOR FUNDING
THIS WORK.
I'M LOOKING FORWARD TO
QUESTIONS.
>> THANK YOU.
THERE ALREADY LOTS OF QUESTIONS.
WE HAVE UNTIL 4:15 FOR
CONVERSATION THAT FOLLOWS.
AND I THINK IT'S CLEAR FROM EACH
OF THESE THAT THERE ARE NOVEL
ISSUES THAT YOUR WORK RAISES FOR
THE FIELD.
RATHER THAN BIOLOGY IT DOWN FOR
MY KEY TAKEAWAYS WE'LL DIVE IN
WITH A QUICK ROUND ROBIN, KEY
NEW QUESTIONS THAT YOUR RESEARCH
REALLY RAISES FOR THE FIELD AND
HOW YOU SEE THAT GUIDING MAYBE
SOME OF THE PRIORITIES FOR
ACADEMIC RESEARCH OR FOR NEWG OR
OTHERS.
JOE, I DON'T MEAN TO HAVE YOU
REPEAT ANYTHING, BUT IF YOU WANT
TO KICK OFF BY SAYING HERE'S THE
KEY NEW ISSUE YOUR RESEARCH WITH
RESPECT TO IDENTITY AND
RESTORATION FOR IDENTITY BRINGS
TO THE FIELD.
>> THERE ARE TWO THINGS.
ONE IS METHODOLOGY.
ONE IS PERSONAL IDENTITY SEEMS
TO HAVE BEEN RESTORED IN THE
SMALL SAMPLE.
TALKING TO GABE, HE MAKES A
SIMILAR CLAIM IN THE HASTINGS
CENTER PEOPLE WITH THE OCP
PEOPLE DESTORED TO HEALTH.
IDENTITY ASK COMPLICATED.
THE QUESTIONNAIRE WAS ABOUT
PERSONALITY, RELATIONALITY,
FORMER INTEREST, AN AGGREGATE.
SECOND POINT, METHODOLOGY.
I THINK THAT WHAT I WAS USING
HERE I DID INTELLECTUAL HISTORY
IN COLLEGE.
I READ TEXT FOR MEANING.
I WAS TRAINED TO DO THAT.
WE TOOK THESE NARRATIVES, HAD
TRANSCRIPTS, I READ IT LIKE
LITERATURE, THE INTERPRETER
PROCESS.
IF YOU READ THE FIVE VIGNETTES
IN CAMBRIDGE PART 2, EACH WAS
ITS OWN SHORT STORY.
I THINK WE NEED TO MARRY THE
SCIENCE AND HUMANITIES BETTER
AND THEY ARE BETTER TOGETHER.
THEY REALLY ARE.
I JUST -- QUICK ANECDOTE, IN
2015, THIS IS TOPICAL BECAUSE OF
WHAT RECENTLY THE CONVERSATION
WE'RE HAVING ABOUT PRESIDENTIAL
FITNESS AND HEALTH AND WELLNESS
AND COGNITIVE ISSUES, RIGHT?
THE REAGAN DIARIES WERE
PUBLISHED.
SORRY, PUBLISHED IN 2007.
AS I WAS READING THEM, A
PHYSICIAN, CLINICAL ETHICIST,
AROUND 1986 IN THE BEGINNING OF
THE SECOND TERM OF THE REAGAN
ADMINISTRATION, PRESIDENT REAGAN
BEGAN TO HAVE -- MAKE ERRORS.
HE DIDN'T REMEMBER DAN QUAYLE'S
NAME.
HE WAS FLYING TO CALIFORNIA,
WHICH HE HAD DONE IN HELICOPTERS
ROUTINELY AS GOVERNOR, HE
DIDN'T -- WASN'T ABLE TO TRACK
THE LANDMARKS.
THERE WAS EVIDENCE IN HIS
DIARIES WHICH UP TO THAT POINT
WERE CRISPLY WRITTEN, CLEVER,
MART, BEGINNING TO SHOW
COGNITIVE IMPAIRMENT.
I SHARED THESE FINDINGS WITH A
MEDICAL JOURNALIST WHO COVERS
PRESIDENTIAL HEALTH BACK AT THAT
TIME.
AND BECAUSE IT WAS
IMPRESSIONISTIC THERE WASN'T A
LOT OF INTEREST.
IN 2015, JOURNAL OF ALZHEIMER'S
DISEASE, THEY DID A COMPARISON
OF PRESIDENTIAL PRESS
CONFERENCES OF GEORGE HERBERT
WALKER BUSH AND PRESIDENT
REAGAN, AND THEY FOUND PRESIDENT
REAGAN IN THE SECOND TERM HAD
DEIMPAIRED IMPAIRED SYNTAX, POOR
WORD CHOICE, LESS CONTENT,
PREDICTORS OF ALZHEIMER'S, WHICH
OF COURSE HE DISCLOSED HAVING IN
1994, THE POIGNANT LETTER TO THE
AMERICAN PUBLIC.
MY POINT HERE IS THESE
NARRATIVES IN HIS DIARIES WERE
LEADING INDICATOR AND HYPOTHESIS
GENERATORS FOR SOMETHING THAT
WAS EMPIRICALLY STUDIED LATER
ON.
THE POSITIVE POWER OF NARRATIVE
AND KIND OF -- FDA NOW IS
INCREASINGLY ASKING FOR PATIENT
PERCEPTIONS OF EFFICACY, LOOKING
FOR BIOMARKERS, PERCENTAGE
MARKERS, IN THE NEUROPSYCH OR
NEUROETHICS SPACE TALKING ABOUT
DEPRESSION AND RELATIONSHIP AND
IDENTITY IT'S VERY HARD, YOU
COULD PUT THE -- YOU CAN HAVE A
HUNDRED TRAIL Bs, YOU WON'T
CAPE -- CAPTURE WHO THEY WERE
AND WHO THEY BECOME.
THE PLEA THAT ALLOWS US TO NOT
DISCRIMINATE AGAINST LITERARY
METHODS OR HUMANITIES BUT SEE
THEM AS PART OF THE WAY OF
CAPTURING THE FULLNESS OF THE
WORK WE'RE DOING IN ADDITION TO
THE NEUROIMAGING,
ELECTROPHYSIOLOGY, EACH DESERVE
EACH OTHER.
>> THAT'S REALLY HELPFUL.
A QUICK FOLLOW-UP, IN THINKING
ABOUT METHODOLOGY BRINGING THESE
DIFFERENT CONCEPTS TOGETHER,
IDENTITY IS A LOADED TERM.
>> RIGHT.
>> CONCEPT OF CONTINUITY,
IDENTITY, WHAT YOU'RE MEASURING
IN METRICS AND LANGUAGE.
WHEN YOU PUT UP RESTORATION OF
IDENTITY, BUT DESCRIBED THE
PERSON WHO SAID THEY WERE IN A
CONVERSATION WITH THEIR PARTNER
AND REALIZED THEY NEEDED A NEW
RELATIONSHIP BECAUSE THEIR
INTERESTED DIVERGED.
>> IT WAS A FRIEND, YEAH.
>> I WONDERED THE EXTENT TO
WHICH IT IS, YOU KNOW, IT'S
IDENTITY OR SELF OR
DISCONTINUITY OR CHANGES.
HOW YOU THINK ABOUT THE LET'S
VERSUS --
>> YEAH, I THINK THE ALTERNATIVE
REALLY IS PARABLES FICTITIOUS
CREATIONS OUT OF CREATIVE MIND
BUT WHAT WE'RE DOING HERE,
THAT'S WHY THE THICK
DESCRIPTIONS ARE REALLY
IMPORTANT BECAUSE I'M
SUMMARIZING AND YOU HAVE TO LOOK
AT WHAT THE INDIVIDUAL SAYS,
WHAT THEIR FAMILY MECHANICS
SAID, WHAT PEOPLE WHO ARE IN
DEEP RELATIONSHIPS SAY ABOUT THE
NATURE OF THE RELATIONSHIP AND
SO I THINK IT'S DEEPER SORT OF
DIVE INTO WHO THIS PERSON IS.
AND OF COURSE SOME IS
CONSTRUCTIVE, AND IF WE HAVE AN
EMPIRICAL METHOD TO TEST THE
HYPOTHESIS THAT THIS RESTORES
IDENTITY WHICH I THINK IT DOES,
MAYBE WE'LL CALL IT SOMETHING
PERSONALITY, MAYBE IT'S
IDENTITY, SENSE OF SELF, ELASTIC
TERMS.
BUT I THINK THEY ARE PROBEATIVE
AND ASK US TO ASK THE NEXT SET
OF QUESTIONS.
FOR EXAMPLE, A SIMPLER THING
THAT CAME OUT OF OUR STUDY WAS
PATIENTS, SUBJECTS WERE TELLING
US THEIR SLEEP PATTERNS CHANGE.
WHEN WE DO THE NEXT TRIAL, WE'LL
STUDY SLEEP IN A FORMAL WAY.
WE DIDN'T KNOW THAT WAS A
DIMENSIONALITY OF THE DBS IN THE
CENTRAL LATERAL WING OF THE
THALAMUS, RIGHT?
BUT NOW WE DO.
AND SO SOMETIMES THEY ARE GOING
TO REPORT STUFF WHICH IS MUCH
SIMPLER TO UNDERSTAND.
SLEEP PATTERNS, HEADACHES, FOR
EXAMPLE, THAT WE CAN INFORMALLY
TEST USING METRICS ESTABLISHED.
IT'S HARD TO TEST IDENTITY.
THERE'S NO TEST FOR IDENTITY.
I MEAN, YOU KNOW, PSYCHOANALYSIS
OR SOMETHING.
IT WAS COMPLICATED.
YOU'RE RIGHT TO POINT THIS OUT.
BUT WE ALSO DON'T WANT TO ENGAGE
IN SCIENTIFIC REDUCTIONISM AND
SAY, OH, THERE'S A TEST FOR THIS
AND IT CAPTURES THAT.
BETTER WRITERS THAN US HAVE
TRIED TO CAPTURE WHAT IDENTITY
IS, SHAKESPEARE, ET CETERA.
>> YEAH.
THAT'S HELPFUL.
CLEARLY AN IMPORTANT ISSUE FOR
US TO TACKLE.
YOU MENTIONED HELEN MAYBERG.
IT'S AN ISSUE SHE'S BEEN
EXPLORING AND HAS IDEAS ON
RESEARCH WITH INTERVIEWS FOR
DBS, BEING ABLE TO MEASURE
SIMILAR METRICS.
>> ON HELEN'S WORK ONE OF THE
VERY INTERESTING THINGS ABOUT
THE DEPRESSION WORK SHE DID IS
THAT WHEN THERE'S THEY ARE SO
MORBIDLY DEPRESSED AND THERAPIES
FAILED THEM, THEY ARE APATHETIC,
THEY CAN'T GET OUT OF BED,
REALLY PSYCHOTICALLY AND DEEPLY
DEPRESSED, THEY GET TREATMENT
AND THEY BECOME WELL ENOUGH TO
HAVE THE PROBLEMS THEY HAD
BEFORE THEY GOT SO DEPRESSED.
THERE'S A LET'S OF THEMSELVES
AND HELEN WILL TELL YOU THAT.
THE POINT IS, AGAIN, TO GET BACK
TO PTO QUESTION, POST TRIAL
OBLIGATION, YOU MAKE THEM BETTER
THAT WAY BUT HAVE TO HELP THEM
IN THE WAY YOU MADE THEM
PERSEVERE AROUND CONTINUE WITH
THEIR LIVES IN A MEANINGFUL WAY.
>> AGREED.
A GOOD AND IMPORTANT ISSUE TO
CONSIDER ON THE AGENDA.
INCLUDING WHAT ARE THE MORE
COMPLEX POST-TRIAL OBLIGATIONS
WE NEED TO THINK ABOUT AND
SUPPORT SYSTEM THAT EXIST.
ALEX, ON THE HOT SEAT FOR A
MOMENT HERE TO ASK YOU A SIMILAR
QUESTION.
I ASKED AT THE END OF YOUR
PRESENTATION THAT MIGHT ADDRESS
SOMEWHAT, YOU KNOW, THE ANSWER
TO THIS QUESTION OF WHAT NEW
ISSUES DOES THIS PUT ON THE
AGENDA REALLY THROUGH WHAT YOU
PRESENTED HERE.
I WONDER IF IN THAT ANSWER YOU
MIGHT ALSO REFLECT ON THE
DIFFERENCE BETWEEN WHAT YOU'RE
PRESENTING WITH CONVERTER VERSUS
CLASS FIRE CROSS-PARTICIPANT
CLASSIFIER WORK YOU PRESENTED IN
THE PREVIOUS PAPER, AND, YOU
KNOW, I THINK MANY OF US THOUGHT
IT WOULD TAKE LONGER TO CROSS
THIS NEW THRESHOLD YOU'RE
PRESENTING TODAY, IF YOU COULD
TALK ABOUT THAT AND WHAT YOU SEE
AS THE ISSUES THAT RAISES OR
DOES IT RAISE FOR NEUROETHICS OR
NEWG TO CONSIDER FURTHER.
>> YEAH, THANKS.
THAT'S A BIG QUESTION.
I THINK THE EASY ANSWER IS THESE
THINGS ARE ADVANCING QUICKLY.
WE DON'T KNOW WHAT INFORMATION
WE'LL GET OUT OF THESE
RECORDINGS.
TURNS OUT AT EVERY STEP IT'S
MORE THAN WE SUSPECTED.
SO, I THINK REALLY THE ANSWER IS
LIKE WHAT YOU WROTE IN YOUR
BOOK, EVERYBODY SHOULD READ
NITA'S BOOK.
THAT'S THE SOLUTION HERE.
THIS IS POTENTIALLY A DANGER.
POTENTIALLY LIKE A KIND OF BIG
DEAL, ESPECIALLY WHEN WE ARE
INTERESTING THIS AGE OF
NEUROTECH WHERE THERE'S GOING TO
BE DEVICES WE USE MAYBE EVEN FOR
LIKE CONSUMER SORT OF
ELECTRONICS PURPOSES THAT MIGHT
BE ABLE TO EXTRACT QUITE A BIT
OF INFORMATION FROM YOU WITHOUT
YOUR CONSENT OR WITHOUT REALLY
YOU KNOWING THAT IT'S GETTING
THAT INFORMATION FROM YOU.
SO, I THINK, I'M NOT REALLY SURE
WHAT THE SCIENTIFIC ANSWER IS.
LET'S JUST KEEP GOING.
KEEP DOING WHAT WE CAN SO WE
KNOW WHAT LIMITATIONS ARE.
THAT'S KIND OF THE COURSE THAT
WE'VE PLOTTED FROM HERE.
IF THERE ARE SOLUTIONS THEY
HAVE TO BE REGULATORY, THAT'S
WHERE THE ANSWERS TO THIS LIE.
>> YOU MENTIONED ONE THING IN
YOUR REMARKS ABOUT, YOU KNOW,
BOTH ARRESTING DATA AND ALSO
WHAT'S IN EXISTING REPOSITORIES,
THAT MIGHT RAISE NEW ISSUE WITH
THINKING ABOUT HOW DO WE THINK
ABOUT POTENTIAL RISK AS IT GETS
BETTER AND BETTER AT THE
POSSIBILITY OF RE-IDENTIFICATION
OF DATA THAT'S EXISTING.
AND SO WITHOUT BEING TOO
FUTURISTIC BUT RECOGNIZING THIS
IS GOING MUCH FASTER THAN ANY OF
US ANTICIPATED, IF YOU MIGHT
JUST UNPACK THAT A LITTLE BIT
AND SORT OF WHAT YOU WERE
THINKING ABOUT BOTH RESTING
STATE DATA BUT EXISTING
REPOSITORIES AND WHAT MIGHT BE
GLEANED FROM A PARTICULARLY --
WORK THAT SOMEBODY IS DOING IF
THERE'S THE POSSIBILITY OF
DECODING OTHER INFORMATION IN
THE EXISTING DATASETS.
>> YEAH, YEAH.
SO THAT'S WHAT I THINK ONE OF
THE BIG NEW WORRIES IS BASED ON
OUR WORK.
OUR LAST PAPER WE SHOWED THAT
YOU CAN DO THIS DECODING BUT YOU
NEED A LOT OF DATA FROM EACH
PERSON WHICH PUTS REAL LIMITS ON
HOW FAR YOU CAN GO.
MOST PUBLIC DATASETS WOULD BE
SAFE UNDER THAT KIND OF SYSTEM,
RIGHT?
BUT NOW IT SEEMS LIKE IF YOU
ONLY NEED A LITTLE BIT OF DATA
FROM A PERSON THAT'S ALIGNED,
THAT WE HAVE OTHER PEOPLE'S DATA
FOR, IF THERE'S A PUBLIC
REPOSITORY OF fMRI DATA MAYBE
YOU COULD COLLECT JUST LIKE A
LITTLE PIECE OF THAT, MATCHING
SORT OF STIMULI TO BUILD THIS
BRIDGE BETWEEN YOUR DECODER AND
PUBLIC DATASET TO DECODE
INFORMATION FROM THE PEOPLE IN
THIS PUBLIC REPOSITORY, WHERE
THEY CERTAINLY DIDN'T CON
TONIGHT THAT.
THAT SEEMS LIKE A DEEPER THING
THAN WHAT MOST PEOPLE THINK AN
fMRI STUDY IS, WHICH IS YOU GO,
PUSH BUTTONS, DO A GO-NO GO
TASK.
MAYBE IT GOES DEEPER.
RESTING STATE IS ONE OF THE
SCARIEST THINGS HERE.
WE HAVEN'T SHOWN THAT'S POSSIBLE
TO DECODE FROM RESTING STATE
DATA.
WE HAVEN'T GONE THAT FAR.
I'M RAISING IT AS A POSSIBILITY
BECAUSE I DO THINK IT'S REALLY.
IF YOU HAVE ENOUGH RESTING STATE
DATA FROM A PERSON, RESTING
STATE FOR THOSE WHO MAYBE AREN'T
FAMILIAR, NEUROIMAGING WORLD,
COMMON TASK, LACK OF TASK FOR
fMRI STUDIES.
YOU PUT SOMEONE IN A SCANNER,
HAVE THEM LOOK AT A DOT FOR 15
MINUTES, HALF AN HOUR, WHILE YOU
RECORD fMRI ACTIVITY.
AND TURNS OUT YOU CAN LOOK AT
CORRELATIONS IN DATA TO DEFINE
BRAIN NETWORKS IN A RELIABLE AND
REPEATABLE WAY.
IT'S VERY EASY TO DO,
EXPERIMENTAL, SINCE IT'S BECOME
POPULAR AS LIKE A THING TO USE A
LOT OF STUDIES.
THERE'S A LOT OF INTERESTING
INFORMATION ABOUT NEUROANATOMY
AND ORGANIZATION OF COGNITION
FROM RESTING STATE DATA.
BUT I THINK THE PRESUMPTION WE
MAKE, PEOPLE WHO PARTICIPATE AND
RESEARCHERS MAKE IS THAT YOU'RE
NOT ACTUALLY ABLE TO GET ANY
MEANINGFUL INFORMATION OUT OF
THAT DATA.
YOU'RE THINKING IN YOUR OWN
HEAD.
THERE'S-- NOBODY CAN LOOK IN
THERE AND SEE WHAT'S GOING ON.
YOU'RE SEEING LARGE SCALE
CORRELATIONS, THIS NETWORK OR
THAT NETWORK, BUT I THINK
THERE'S A REAL POSSIBILITY THAT
IT COULD GO FURTHER THAN THAT
AND I THINK THAT -- I DON'T
KNOW, THAT RAISES QUESTIONS FOR
WHAT WE SHOULD DO WITH RESTING
STATE DATA IN PARTICULAR.
IT'S A DIFFERENT BEAST THAN
OTHER fMRI DATASETS, NOT A
TASK YOU'RE NOT THINKING ABOUT
ANYTHING INTERESTING, WHATEVER,
JUST DOING THE EXPERIMENT YOU
WERE TOLD TO VERSUS OPEN-ENDED
THINKING ABOUT ANYTHING LIKE
MAYBE THAT HAS POTENTIAL TO LEAK
A LOT MORE SENSITIVE
INFORMATION, I THINK.
>> TO BE EXPLICIT, ARE WE
WALKING BACK THEN THE CLAIMS OF
TRAINED ON ONE PERSON, CAN'T BE
USED ON ANOTHER PERSON, BECAUSE
CONVERTER NOW MAKES THAT
POSSIBLE?
>> YEAH, THAT STILL REQUIRES
SOME DATA FROM THE PERSON,
RIGHT?
I DON'T THINK WE CAN GET TO THE
POINT OF REQUIRING NO DATA FROM
THE PERSON.
I JUST DON'T THINK THAT'S GOING
TO WORK.
THERE'S NOT ENOUGH INFORMATION
TO DO THIS MAPPING.
BUT, YEAH, WE'RE PUSHING THE
CEILING --
>> DOWN MUCH FURTHER.
>> YEAH, YEAH.
>> I SAW IN DECEMBER SOMEBODY
HAD AN EEG PAPER USING SIMILAR
METHODOLOGY TO WHAT YOU'RE
DOING.
YOU SIMULATED fNIRS IN THE
APRIL PAPER.
ARE YOU PUSHING BEYOND
HEMODYNAMIC DATA INTO EEG DATA
AS WELL AS STILL IN HEMODYNAMIC
MODELS, DID YOU ALSO TEST NEW
CONVERTER ON fNIRS DATA?
>> WE'RE STICKING WITH
HEMODYNAMIC DATA, FOR NOW.
WE'RE WORKING ON TRYING TO GET
SOME fNIRS DATA WITH THIS
SETUP.
WE DON'T KNOW WHAT THAT LOOKS
LIKE BUT HOPEFULLY WE'LL HAVE
RESULTS IN NOT TOO LONG.
I'M SKEPTICAL ABOUT EEG RESULTS,
COMPOUNDS ARE STILL MESSY, BUT I
DON'T KNOW, WE'LL SEE WHAT
HAPPENS WITH THAT.
THERE'S ALSO BEEN SOME WORK,
RECENT WORK ON VISUAL
RECONSTRUCTION FROM EEG IMAGING
THAT'S BEEN VERY EFFECTIVE LIKE
REMARKABLY MORE THAN WE THOUGHT
IT SHOULD HAVE BEEN.
I THINK EVERY YEAR, EVERY FEW
MONTHS WE SEE THE AMOUNT OF DATA
YOU CAN GET OUT OF THESE SOURCES
WE'VE HAD FOR A LONG TIME KEEPS
INCREASING AND INCREASING.
>> EVERY FEW MONTHS, LIKE YOU
JUST SAID.
>> YEAH, ESPECIALLY WITH LIKE
A.I.
SO BETTER A.I. MODELS, REALLY
ENABLING A LOT OF THIS, AND
THAT'S LETTING US PUSH THINGS
MUCH FURTHER.
>> THESE ARE DEFINITELY TWO HUGE
ISSUES, AND IS IT TRISTAN.
>> TRISTAN.
>> GREAT.
I WANTED TO MAKE SURE I GOT THAT
RIGHT.
TRISTAN, GIVEN WHAT YOU'RE
SEEING ABOUT BEING ABLE TO HAVE
EEFFECTIVE TOOL KIDS,
BRINGING -- BRIDGING TOGETHER
INDUSTRY AND ACADEMIA WORK, FOR
TOOL KITS, WHAT DO YOU SEE AS
THE NEW ISSUES THAT ARE ARISING
FROM THE WORK YOU'RE DOING IN
THIS SPACE, THE KEY NEW FINDINGS
THAT ARE PUSHING THE FIELD
FORWARD IN THIS SPACE.
>> YEAH, GOOD QUESTION.
WE'RE STILL GOING THROUGH ALL OF
OUR DATA SO EVERYTHING WITH THE
CAVEAT IF IT'S PRELIMINARY, I
THINK THERE'S -- SOMEONE BROUGHT
UP IN THIS WORKSHOP, I THINK
JENNY, NEUROETHICS
IMPLEMENTATION RESEARCH, A LOT
THAT COULD BE EXPLORED THERE
BECAUSE EVERYTHING'S SO
COMPLICATED AND INTERCONNECTED,
PEOPLE ARE WORKING FROM
DIFFERENT ASSUMPTION, PRACTICES,
WHEN YOU PUT THOSE FOLKS
TOGETHER IN THIS SPACE TO DO
NEUROTECHNOLOGY RESEARCH AND
COMMERCIALIZE IT, THERE'S A LOT
OF OPPORTUNITIES FOR ERROR TO
HAPPEN, AND JUST LOOKING FORWARD
THERE'S GOING TO NEED TO BE MORE
EXPLICIT CONVERSATIONS WITH THE
STAKEHOLDERS IN THIS SPACE AT
VARIOUS POINTS THROUGHOUT THE
NEUROTECHNOLOGY RESEARCH AND
DEVELOPMENT PROCESS.
PEOPLE ARE SAYING, HEY, WE'LL
HAVE TOOL KITS MADE AND WE'LL BE
READY TO WASH YOUR HANDS OF IT
BUT IT NEEDS TO BE AN ONGOING
CONVERSATION, ESPECIALLY BECAUSE
AS WE'RE HEARING LIKE THESE
TECHNOLOGY WAS CHANGING,
IMPROVING SO RAPIDLY, SO IT
MIGHT WORK WELL TODAY, MIGHT NOT
NECESSARILY APPLY OR BE THE SAME
TEN YEARS FROM NOW, THE
TECHNOLOGIES BEING DEVELOPED ARE
SO MUCH MORE POWERFUL AND CAN
GET MORE ACCURATE.
HOW WE SET UP THIS SYSTEM THAT
AFFORDS FLEXIBILITY AND ALLOWS
DIFFERENT GROUPS TO MEET THOSE
EVOLVING CHALLENGES.
>> THAT'S HELPFUL.
I WOULD IMAGINE THERE'S GOING TO
BE SERIOUS CONVERGENCE OF WORK.
WE WERE HEARING ABOUT THOSE FROM
JOE AND ALEX OF IDENTITY AND
QUESTIONS OF NEUROSTIMULATION,
ESPECIALLY WITH NEUROTECHNOLOGY
MOVING FROM READ BUT WRITE
CAPABILITIES AS WELL ABOUT THE
EVOLVING CONVERSATION THAT'S
GOING TO NEED TO BE HAD.
AND THE QUESTION HOW ULTIMATELY
WE'RE GOING BRIDGE THAT GAP.
STAY TUNED.
RESEARCH WILL BE IMPORTANT.
LET ME OPEN TO OTHER QUESTIONS
BECAUSE I'M HOGGING THE
CONVERSATION AND I KNOW THAT WE
HAVE A LOT OF QUESTIONS BREWING
BETWEEN EVERYBODY WHO IS HERE.
LET ME SEE IF THERE ARE OTHER
QUESTIONS BECAUSE IF NOT I COULD
TALK TO THESE GUYS ALL DAY LONG
BUT I KNOW THERE ARE OTHER
QUESTIONS FROM THE GROUP.
SO RAISE YOUR HAND IF YOU'D LIKE
TO JUMP IN.
>> AMY HAS A GREAT QUESTION IN
THE CHAT.
>> WITH THE CONVERSATION YOU PUT
INTO THE CHAT HERE.
>> SORRY, I WAS MOSTLY WRITING
THAT FOR JOE.
IT'S A RELEVANT CONVERSATION.
IT'S JUST ABOUT THE IDEA OF
PERSONAL IDENTITY AND WHETHER
WE'RE RESTORING PERSONAL
IDENTITY.
I THINK WE HAVE UNDERESTIMATED
THE DISRUPTION TO SENSE OF SELF
OR IDENTITY THAT ANY SERIOUS
ILLNESS PRESENTS.
WE'VE HAD SIMILAR EXPERIENCES,
INTERVIEWING INDIVIDUALS WHO
HAVE HAD DEEP BRAIN STIMULATION,
HAVE OFTEN A SEPARATE PROJECT
INTERVIEWING PEOPLE WITH
PSYCHEDELIC EXPERIENCES, A
DIFFERENT TYPE OF IMPACT ON THE
BRAIN.
WE'RE HEARING SIMILAR THINGS
ABOUT, YOU KNOW, WE'RE LOOKING
SPECIFICALLY AT THIS CRITIQUE
PSYCHEDELIC EXPERIENCE IS A
DIFFERENT TRANSFORMATIVE
EXPERIENCES THAT CHANGES YOU IN
SOME FUNDAMENTAL WAY AND YOU
CAN'T KNOW WHAT IT IS BEFORE
DOING IT SO THEREFORE IT
THREATENS YOUR ABILITY TO GIVE
INFORMED CONSENT.
SIMILAR ARGUMENTS HAVE BEEN MADE
IN LITERATURE ABOUT DEEP BRAIN
STIMULATION AT LEAST IN THE
EARLY DAYS AND I THINK SOME
RESEARCH BEING DONE MOSTLY
FUNDED BY THE BRAIN INITIATIVE
HAS COUNTER BALANCED THAT
SAYING, NO, IT'S NOT CHANGING
PEOPLE FUNDAMENTALLY IN THEIR
PERSONALITY AND SENSE OF SELF.
IT MIGHT BE RESTORING THEM IN
SOME WAY TO THEIR PRE-DISEASE
STATE OR CHANGING THEM SLIGHTLY
BUT NOT IN FUNDAMENTAL WAYS
WHERE GOALS CHANGE IN A WAY THEY
CAN'T HAVE MADE DECISIONS BEFORE
THAT.
ANYWAYS, MY POINT WAS JUST THAT
THIS IDEA OF SOME RESTORATION OR
CHANGE TO IDENTITY, WHAT'S THE
MORAL AND ETHICAL SIGNIFICANCE?
WHY DO WE CARE ABOUT THAT?
I DON'T REMEMBER IF IT WAS BEN
OR SOMEBODY MADE THE POINT LOTS
OF THINGS HAPPEN IN CHILDHOOD, I
WOULD ARGUE ALSO IN ADULTHOOD
THAT CHANGE GOALS, PRIORITIES,
SENSE OF SELF AND IDENTITY.
WE DON'T GIVE MORAL SIGNIFICANCE
OR WEIGHT TO THOSE THINGS SO WHY
DO WE CARE SO MUCH IN THIS
SPACE?
IF WE DO CARE WHAT IMPLICATIONS
DOES IT HAVE FROM HOW WE THINK
ABOUT THE ETHICS OF THESE
INTERVENTIONS.
>> I DON'T KNOW, JOE, IF YOU
HAVE A THOUGHT.
>> IT'S INTERESTING.
I WAS READING ABOUT THE HISTORY
OF SCIENCE, WHEN A PHYSICAL
CHEMIST AND PHYSICIST USING
DIFFERENT METHODS AGREED ON THE
WEIGHT OF ELECTRON, SCIENTIFIC
CONVERGESSENS.
WHAT YOU SAID ABOUT PSYCHEDELICS
AND DBS IS A CONVERGENCE OF
SIMILAR FINDINGS.
I THINK THE REASON WHY INJURY
AND ILLNESS IS SO TROUBLING TO
US, WE ALL CHANGE, YOU KNOW,
OVER TIME.
WE MATURE AND EVOLVE.
I THINK IT'S THE RANDOMNESS AND
DISRUPTION OF EXPECTED
TRAJECTORY, AND SO WE ARE NOT
ENHANCING, WE'RE NOT CHANGING.
WE'RE SORT OF RESTORING.
YOU'RE GETTING BACK ON THE SLOPE
OF THE OLD CURVE THAT WAS
RADICALLY CHANGED.
I THINK THIS GETS BACK TO WHAT
PEOPLE WANT TO BE BACK TO WHO
THEY WERE.
THEY WANT TO RESTORE
RELATIONSHIPS.
THEY WANT TO CONTINUE TO DO
THINGS THEY USED TO ENJOY.
I THINK IT'S KIND OF LIKE --
IT'S A CONTINUITY ARGUMENT VERBS
US DISCONTINUITY OF THE ILLNESS
OR SEVERE INJURY.
>> JOHN, JUMP IN.
>> A QUESTION FOR THE GROUP,
PERSPECTIVES AND WISHES OF
FAMILY MEMBERS, SOME OF YOU
PROBABLY PUBLISHED ON, THEIR
VIEWS AND PATIENT VIEWS OFTEN DO
NOT ALIGN.
>> RIGHT.
THE SUBJECT, ONE OF THE SUBJECTS
IN OUR STUDY WITH THE BIGGEST
CHANGE IN TRAILS B FOR HIS OWN
REASONS THOUGHT HE WAS LESS HELP
THAN OTHER MEMBERS OF THE STUDY
BUT HIS FAMILY MEMBERS FROM THE
OUTSIDE AS OBSERVERS THOUGHT
THAT.
THAT POINTS TO THE IMPORTANCE OF
METHODOLOGY THAT IF YOU CAN
TRIANGULATE, YOU GET A BETTER
VIEW OF WHAT'S ACTUALLY
HAPPENING.
AND I THINK SOMETIMES YOU NEED
INSIGHT.
YOU TAUGHT A COURSE ON
SABBATICAL AT PRINCE TELL,
BIOETHICS, AND GALEN WROTE ABOUT
PEOPLE WHO WERE ILL, PEOPLE WHO
WERE MORE EXPERIENCED WITH THE
ILLNESS TO PROVIDE PERSPECTIVE
AS THEY GO THROUGH THE
EXPERIENCE, 4th CENTURY GRECO
ROMAN PHYSICIAN.
SOMETIMES WE NEED EXTERNAL
PERSPECTIVES.
HAVING SAID THAT THERE CAN BE
CONFLICTS OF INTEREST AND OTHER
MOTIVATIONS.
THEY WANT THEM TO GET WELL IN A
CERTAIN WAY.
WE HAVE TO BE CAUTIOUS WITH
THAT.
BUT I THINK THESE ARE THE PEOPLE
WHO KNOW THEM THE BEST, WITH
WHOM THEY HAVE INTIMATE
RELATIONSHIPS, AND RELATIONALITY
FROM FEMINIST BIOETHICS IS
IMPORTANT.
THERE ARE LOTS OF CONNECTIVITY
HERE AND WE'RE NOT ADAMISTIC.
WE ARE MOLECULAR.
WE LIVE IN RELATIONSHIPS.
THEY CAN PROVIDE INSIGHT WHO
WE'VE BEEN AND WHO WE CAN
BECOME.
>> CERTAINLY ISSUES OF
OBJECTIVITY AND SUBJECTIVITY AND
RELATIVENESS OF THAT IS SURELY
QUITE IMPORTANT BUT I'M ALSO
THINKING IN TERMS ABOUT AS YOU
ALLUDED TO, WHAT COULD BE
CONFLICTS OF INTEREST.
THE PATIENT REALLY WANTING THIS
BECAUSE THEY WANT A DIFFERENT
LIFE.
AND THE FAMILY LOOKING AT THE
RISK, RISK/BENEFIT, WITH A
DIFFERENT PERSPECTIVE AND
THEREFORE DIFFERENT CONCLUSION.
>> I COULD BRIEFLY INTERJECT,
PERSKI WROTE ABOUT PEOPLE WHO
ARE RETARD AND FAMILIES ALLOWING
THEM TO GO IN THE WORLD, THE
DIGNITY TO INTEGRATE, GET A JOB,
SHELTER, WHATEVER.
ONE OF THE THINGS WE OBSERVED IN
PART 1 OF OUR STUDY WAS THE
CHALLENGE THAT FAMILIES HAD IN
LETTING GO AND LETTING THEIR
LOVED ONES ASSUME THE RISK OF
BEING A SUBJECT IN THIS PHASE 1
TRIAL.
AND THE INDIVIDUALS,
PARTICIPANTS, WHO ALL HAD
DECISION-MAKING CAPACITY WANTED
TO TAKE THE RISK BECAUSE THEY
KNEW HOW MISERABLE THEY WERE,
LONGED FOR PRIOR SELF, PART OF
THE NEGOTIATION, JOHN, WAS THE
FAMILY MEMBERS ALLOWING THEIR
LOVED ONES TO BE AUTONOMOUS, AND
TO TAKE THAT ON FOR THEMSELVES
BECAUSE THEY WERE NOT LIVING THE
LIVES THAT THOSE WITH SEVERE
BRAIN INJURY HAD BEEN LIVING,
AND ACTUALLY THEY WERE MORE RISK
AVERSIVE THAN THE PARTICIPANTS
WERE.
>> JEN?
>> THANKS FOR THAT PERSPECTIVE.
I WANT TO SWITCH GEARS AND MY
FIRST QUESTION IS DIRECTED TO
TRISTAN.
IF IN YOUR RESEARCH UNDER AIM 1
YOU WERE LOOKING AT INTERVIEWING
BOTH PATIENTS AND RESEARCH
PARTICIPANTS.
SO MY QUESTION, I'D LIKE TO HEAR
FROM THE LARGER PANEL, A LOT OF
TIMES WE TEND TO RESEARCH, TALK
TO RESEARCH PARTICIPANTS, WHAT
HAPPENED TO BE THE MOST RISK
AVERSE, PUTTING THEMSELVES
FORWARD IN SCIENCE, WE
EXTRAPOLATE ACROSS THE
POPULATION SO I'M CURIOUS IN
YOUR COHORT ARE YOU INCLUDING
THOSE THAT ARE REPRESENTATIVES
OR MAYBE PATIENT ADVOCACY
ORGANIZATIONS WITH A BROADER
VIEW OF THE POPULATION BUT ALSO
HOW DOES THIS PLAY INTO THE
CLASSIC ADOPTION CURVE OF
INNOVATION, WE'RE FOCUSING ON
THOSE EARLY ADOPTERS AND MAYBE
NOT THE EARLY MAJORITY WHICH IS
WHERE WE NEED FURTHER CLINICAL
ADOPTION.
IF YOU COULD ADDRESS THAT AND
THEN PERSPECTIVE FROM THE PANEL.
>> VERY GOOD AND COMPLEX
QUESTIONS TO ANSWER.
WHEN WE RECRUITED FOR
PATIENT/RESEARCH PARTICIPANT
GROUP WE HAVE PARTNERED WITH
PATIENT ADVOCACY GROUPS, THERE'S
ALSO LARGE NATIONAL DATABASE,
THAT WE RECRUITED SIGNIFICANT
AMOUNT OF PARTICIPANT.
WE GOT A GOOD RANGE OF
RESPONSES, HAD PEOPLE WITH NOT
GOOD EXPERIENCES AND OTHER
PEOPLE WHO HAD AMAZING
EXPERIENCES, AND OUR
PRE-SCREENING WE WERE COGNIZANT
OF RANGE OF EXPERIENCES, TO MAKE
SURE THOSE WERE REFLECTED.
THE SECOND QUESTION I'M HAVING A
HARD TIME ANSWERING HOW DO WE --
COULD YOU ASK AND TELL ME MORE
WHAT YOU'RE HOPING TO HEAR?
AND I'M HAPPY TO HAVE OTHER
CHIME IN.
>> YES, PLEASE CHIME IN.
THERE'S A CLASSIC CURVE OF
ADOPTION, EARLY ENTHUSIASTS ARE
OUTSIDE THE APPLE STORE, THEY
WANT TO BE THE FIRST TO HAVE IT.
THE EARLIER ADOPTERS TAKE A
LITTLE BIT LONGER AND THOSE ARE
THE PEOPLE THAT ARE SIGNING UP
FOR CLINICAL TRIALS.
WILLING TO PUT THEMSELVES
FORWARD.
THE QUESTION IS, WHERE CAN WE
START TO MOVE OUR FOCUS TOWARDS
THOSE EARLY MAJORITIES, THINK
THOSE ARE THE PEOPLE MORE
SKEPTICAL ON THE EARLY
TECHNOLOGY BUT WE HAVE TO REALLY
UNDERSTAND THEIR PERSPECTIVES
AND HESITANCY OF GOING FOREWARD,
IMPLANT, MINIMALLY INVASIVE OR
TECHNOLOGY DEVICE, WHAT'S BEEN
SAID ABOUT PARTICIPANT
ENGAGEMENT, NOT JUST AS DEVICE
IS BEING DEVELOPED BUT CHECKING
IN THROUGHOUT ESPECIALLY AS MORE
AND MORE PEOPLE ADOPT THESE NEW
TECHNOLOGIES, NOT ASSUMING WE
FOUND OUT EARLY STAGE IS WHAT'S
GOING TO HOLD OVER TIME, HAVING
THAT PERIODIC EXCHANGE OF
INFORMATION I THINK IS ONE WAY
TO DO THAT.
I'M CURIOUS TO HEAR WHAT OTHERS
THINK.
>> I JUST PUT IN THE CHAT
TALKING TO PEOPLE WHO DECLINE
PARTICIPATION IS A GOOD WAY TO
GET AT THAT.
IT'S A HARDER GROUP TO CAPTURE.
RECRUITMENT METHODS ARE NOT SO
CLEAR WHO IS DECLINING AND WHO
IS NOT GETTING OFFERED THINGS.
THAT CAN GIVE YOU AT LEAST THE
OTHER END OF THE SPECTRUM ON
TERMS OF PERSPECTIVE.
>> I THINK THAT'S REALLY
IMPORTANT, THERE'S DEFINITELY X
WORDS OR TWITTER WORDS, PEOPLE
IN THE DISABILITY RIGHTS
COMMUNITY THAT DON'T WANT TO
CHANGE THEIR IDENTITY SO I THINK
WE HAVE TO BE CONSCIOUS OF THAT.
THAT EXISTS WITHIN OUR SOCIETY.
>> ALL RIGHT.
OTHER THOUGHTS?
OTHER QUESTIONS?
>> I HAVE A QUESTION IF I MAY.
>> PLEASE.
>> SO, FOR THE TALK ABOUT
IDENTITY WITH NEUROSTIMULATION,
HOW DIFFERENT ARE THESE CONCERNS
THEN AROUND MEDICATION, LIKE
PSYCHIATRIC MEDICATION, DO WE
NOT HAVE MANY OF THE SAME
CONCERNS?
WHAT'S REALLY NEW AND DIFFERENT
ABOUT NEUROSTIMULATION EXCEPT
FOR THE FACT IT CAN BE TURNED
OFF, CAN YOU STOP TAKING
MEDICATION?
>> PERSONALLY I'VE SEEN SIMILAR
CONVERSATIONS TO AMY'S POINT.
AND OTHER LITERATURES ABOUT
CONTINUITY AND DISCONTINUITY
ITSELF AND IDENTITY.
I THINK INTERESTINGLY IN OTHER
AREAS OF TECHNOLOGY TOO THERE
HAVE BEEN THEORIES OF EXTENDED
PERSONALITY, SO COCHLEAR
IMPLANTS, HEARING AIDS, OR
PROSTHETIC DEVICES, EACH OF
THESE CREATING A DISRUPTION IN
TRAJECTORY AND EXPECTED
TRAJECTORY BUT THEN OVER TIME
INTEGRATION INTO CONCEPT OF
EXTENDED PERSONALITY AND SELF.
THERE IS A LOT TO DRAW FROM TO
SEE IF THERE'S ANYTHING
DIFFERENT IN DBS IN TERMS OF
INTEGRATION, IN THE WAY A PERSON
THINKS AND PROCESS INFORMATION,
IF THAT'S DIFFERENT.
OR THE SAME.
AND WITH PSYCHEDELICS THAT'S A
GOOD PLACE TO LOOK, WHICH IS
LOOKING AT EVEN ANTIDEPRESSANTS
AND OTHER MEDICATIONS, AS PEOPLE
INTEGRATE HOW IT CHANGES
PROCESSING COULD BE USEFUL.
TO ME THIS IS ONE OF THOSE AREAS
WHERE IT'S INTERESTING TO
EXPLORE AND SEE IF THERE'S
ANYTHING DIFFERENT.
A LOT OF TIMES IT'S ONE OF THE
LEADING QUESTIONS, IS THIS A NEW
PROBLEM OR DIFFERENT DIMENSION
OF THE SAME PROBLEM OR IS IT THE
SAME PROBLEM BUT SIMPLY
PRESENTED IN A NEW WAY OR NEW
LENS, CURIOUS WHAT OTHER THINK
IN THIS NEW LENS OR RESEARCH
AREA.
>> I WAS GOING TO ADD A
DIFFERENT EXAMPLE, WORKED WITH
PEOPLE WITH SICKLE CELL DISEASE
WHO HAD GENE THERAPY OR BONE
MARROW TRANSPLANTS, NO LONGER
ARE SICKLE CELL.
AN INTERESTING OUTCOME, I DON'T
KNOW WHO I AM, I'VE HAD SICKLE
SICKLE CELL MY WHOLE LIFE, NOW I
DON'T.
IT'S ANOTHER EXAMPLE HOW, YOU
KNOW, TREATMENT -- WELL, DISEASE
CAN AND ALSO TREATMENT CAN
CHANGE PEOPLE'S IDENTITY.
>> THERE'S ALSO A LOT IN THE
CANCER LITERATURE AS WELL.
PEOPLE WHO FEEL LIKE A CANCER
DIAGNOSIS CAN SUDDENLY CHANGE
THE EXPECTED TRAJECTORY,
INTEGRATED THAT INTO THEIR WORLD
VIEW AND UNDERSTANDING OF SELF,
CHANGES THINGS DRAMATICALLY.
IT'S BEEN WRITTEN ABOUT A GOOD
BIT IN BREAST CANCER LITERATURE
AS WELL.
>> FOR ME THE INTERESTING
QUESTION WHAT DO WE DO ABOUT IT.
I LIKED WHAT JOE WAS TALKING
ABOUT, OWING PEOPLE, I DON'T
KNOW, ABILITY, YOU KNOW, THINGS
TO PROMOTE THEIR ABILITY, BUT I
THINK WE OWE PEOPLE INFORMATION
WHEN THEY ARE JOINING A TRIAL
THIS COULD HAPPEN TO THEM SO WE
NEED TO KNOW A LITTLE BIT MORE
ABOUT WHAT COULD HAPPEN.
BUT I STILL FEEL UNSURE ABOUT
WHAT ELSE WE OWE THEM IN THAT'S
THE RIGHT WAY TO FRAME IT.
>> I HAD A CONVERSATION WITH
HELEN MAYBERG ABOUT THIS TOPIC
RECENTLY.
SHE WAS SAYING SIMILARLY, I'M
SORRY, JOHN, YOUR HAND IS UP.
I'LL COME TO YOU IN JUST A
SECOND.
JOE THOUGHT THERE MAY BE NEED
FOR POST-TRIAL OBLIGATIONS OR
RESOURCES.
THE PROCESS OF INTEGRATION OF
DBS OR TECHNOLOGIES INTO SELF
AND TRAJECTORY THAT PEOPLE GO
THROUGH OVER THE COURSE OF A
YEAR OR YEAR AND A HALF,
PRE-TRIAL TO POST TRIAL,
REQUIRES SUPPORT IN WAYS THAT
MAY NOT BE ADEQUATELY ADDRESSED
RIGHT NOW AND THERE MAY BE AREAS
BEYOND DBS THAT NEED THE SAME
SUPPORT.
THIS MAY BE A CASE STUDIES THAT
HELPS US BROADLY UNDERSTAND A
PROBLEM.
IT MAY AT THE VERY LEAST HELP US
UNDERSTAND A MISSING PIECE OF
MENTAL HEALTH RESOURCES AND
SUPPORT THAT OCCURS, SOMETHING
THAT WHEN SOMEBODY IS DEALING
WITH THIS DRAMATIC CHANGE IN
TRAJECTORY AND EXPECTED LIFE
OUTCOMES.
JOHN?
>> CHRISTINE, YOUR OBSERVATION
ABOUT THE SICKLE CELL PATIENT IS
INTERESTING.
MANY MOONS AGO, ON THE ADVISORY
COUNCIL FOR NIDCD, TO ME IT WAS
REVEALING THAT THERE WERE
MEMBERS OF THE DEAF COMMUNITY
WHO ACTUALLY REJECTED THE USE OF
COCHLEAR IMPLANTS THAT WOULD BE
LIFE CHANGING, AND BECAUSE AS
YOU MENTIONED THEIR CONDITION
WAS PART OF THE IDENTITY THEY
HAD GROWN UP WITH OR THEIR
FAMILIES HAD GROWN UP.
I GUESS MY QUESTION IS ARE WE
LOOKING AT POINTS ALONG THE
CONTINUUM OR AM I TRYING TO MAKE
A SEMANTIC DISTINCTION BETWEEN
THE IDENTITY ONE HAS BASED ON
ONE'S LIFE EXPERIENCE VERSUS,
SAY, TAKING A DRUG OR HAVING A
STIMULATION AND SPECIFIC CIRCUIT
IN YOUR BRAIN WHICH TRULY IS
ALTERING, COULD POTENTIALLY BE
ALTERS PERSONALITY.
IS BASED ON ONE'S LIVED
EXPERIENCE?
I DON'T KNOW IF THERE'S AN
ANSWER.
IS THERE A WAY TO PARSE THIS OUT
TO DEAL WITH OUR -- OUR ISSUE AT
HAND IS WHAT ARE WE DOING
PUTTING ELECTRICITY INTO
PEOPLE'S CIRCUITS IN THE BRAIN
TO HELP AND TREAT THEM.
>> THAT'S THE MILLION DOLLAR
QUESTION, JOHN, PUT ON THE
TABLE.
LET ME TAKE THE REMAINING TWO
COMMENTS, WE'RE RUNNING SHORT ON
TIME AND THEN TURN IT OVER TO
CHRISTINE FOR UPDATES FROM THE
REST OF THE GROUP.
SAMEER?
>> THANKS.
I'LL TRY ANSWER JOHN'S QUESTION
QUICKLY AND BRING UP A POINT
WHICH I THINK IT'S CONTINUING,
JOHN.
THERE'S SOME THINGS THAT ARE
VERY CLEARLY EMPIRICALLY ON THE
INTERVENTION SIDE BUT LET ME TIE
THIS INTO THE COMMENT.
WHAT YOU WERE SAYING WAS
POST-TRIAL RESPONSIBILITY, ET
CETERA, I'D SAY THIS NEEDS TO BE
DONE VERY MUCH WITHIN THE TRIAL,
SOMETHING YOU CAN BUDGET FOR BUT
REINTEGRATION INTO SOCIETY AND
LIFE IS OCCURRING DURING THE
TRIAL, DURING THE TWO AND THREE
YEARS THAT THE TRIAL IS GOING
ON.
AND IT'S NOT SOMETHING THAT'S --
IT'S MORE NECESSARY DURING
BECAUSE THIS IS WHY WE START
PEELING THE ONION, SEEING WHAT'S
UNDERNEATH, WHATEVER THING
YOU'RE TREATING IN TERMS OF
DEVICE BASED STATE.
HOW TO DO THAT, I DON'T KNOW.
SOMETHING A SPECIFIC BUDGET FOR,
OH, ADD THERAPY TO DBS, THIS IS
FINE BUT THIS IS ISN'T THERAPY.
THIS IS SOCIAL SKILLS
REINTEGRATION, TO BE FUNCTIONAL
WHEN YOU WEREN'T BEFORE.
SO, YEAH, IT'S CONTINUING.
THIS IS THE FAR END.
IS THIS LIFE OR A TRIAL-ENDING
INTERVENTION?
>> GREAT.
THANK YOU.
CAROLINE?
>> YES, THANK YOU TO THE
SPEAKERS FOR THIS GREAT
DISCUSSION.
I HAVE A QUESTION FOR TRISTAN.
THANK YOU FOR YOUR PRESENTATION.
I THOUGHT IT WAS VERY
INTERESTING TO THINK ABOUT THE
DIFFERENT CONTRIBUTORS IN THE
SCIENTIFIC ENTERPRISE RESEARCH
AND COMMERCIALIZATION.
I WAS CURIOUS TO HEAR YOUR
THOUGHTS ON NEUROETHICS SCHOLARS
IN YOUR MODEL.
SO, HERE I WAS ESPECIALLY
INTERESTED IN HEARING YOUR
THOUGHTS ON HOW RECEPTIVE THESE
TWO GROUPS THAT YOU DESCRIBE
HERE IN THE ACADEMIC SECTOR,
COMMERCIAL SECTOR ARE TO
INCORPORATING NEUROETHICS
SCHOLARS AND BRINGING THEM INTO
THEIR RESEARCH TO CONSIDER
ETHICAL AND SOCIETAL
CONSIDERATIONS IN THE COURSE OF
THEIR WORK.
AND PERHAPS WHETHER THERE'S
DIFFERENTIAL RECEPTIVITY
DEPENDING ON EACH OF THOSE
GROUPS.
>> YEAH, MY SENSE IS THAT MAYBE
A LOT OF THE INSTITUTIONAL
OFFICIALS MIGHT NOT BE AWARE
LIKE NEUROETHICISTS LIAISONS
EXIST AND THE ROLE THEY PLAY,
NEUROETHICISTS WE COULD DO A
BETTER JOB OF CHAMPIONING WHAT
WE DO IN ADVERTISING HOW WE CAN
HELP OFFICIALS AND RESEARCHERS
AND PHYSICIANS THINK
PROACTIVELY.
YEAH, IT'S THERE BUT NOT TO THE
EXTENT THEY ARE AWARE THOSE ARE
RESOURCES THAT ARE AVAILABLE TO
THEM.
THAT'S SOMETHING I'VE PICKED UP
ON WITH THIS.
I DON'T KNOW IF THAT ANSWERS
YOUR QUESTION.
>> THANK YOU.
WE COULD CONTINUE THIS
CONVERSATION FOR QUITE A WHILE.
THREE HELPFUL PRESENTATIONS,
RAISING A LOT OF FOOD FOR
THOUGHT.
CERTAINLY THINGS ARE HAPPENING
MORE RAPIDLY THAN I THINK ANY OF
US IMAGINED BUT IT'S GREAT TO
KNOW THAT WORK LIKE TRISTAN'S IS
HAPPENING TO HELP CONVERGE THE
CONVERSATIONS AND BRING THE
DIFFERENT VOICES TO THE TABLE
AND THAT ISSUES THAT JOE RAISES
ARE IMPORTANT ONES TO TAKE ON,
POTENTIALLY SERVING AS USEFUL
USE CASE TO THINK BROADLY THAT
AN ISSUE THAT AFFECTS TRIALS
MORE GENERALLY BUT PERHAPS MORE
PROFOUNDLY TO JOHN'S QUESTION
AND POINT, OR NOT.
IT'S A QUESTION TO EXPLORE AND
ONE THAT WOULD BE REALLY USEFUL
TO CONSIDER FOR THE NEWG AGENDA.
LET ME HAND OVER TO CHRISTINE TO
MODERATE THE FINAL ROUNDTABLE
SET OF UPDATES.
THANKS, ALL.
THANKS FOR TERRIFIC
PRESENTATIONS.
>> THANK YOU.
THANK YOU, NITA.
FOR THOSE WHO ARE NEW TO US,
WHAT WE TEND TO DO THEY END IS
HAVE A ROUNDTABLE ASKING EACH
MEMBER FOR UPDATES TO SHARE WITH
THE GROUP.
I'M GOING TO DO THAT BY LOOKING
ACROSS MY SCREEN AND CALLING ON
PEOPLE.
CAROLINE, YOU'RE FIRST.
>> HAPPY TO SHARE, FOR THOSE I
HAVEN'T MET, I'M CAROLINE,
PRESIDENT AND CEO OF DANA
FOUNDATION, SHARING UPDATES
AROUND A PROGRAM WHICH COULD BE
INTERESTING TO MANY PEOPLE ON
THIS CALL GIVEN THE TOPICAL
FOCUS OF THE GROUP, ONE UPDATE
FROM THE FOUNDATION IS THAT WE
HAVE AN OPEN CALL FOR LETTERS OF
INTEREST FOR PILOT PROJECTS IN
THE INTERSECTION OF NEUROSCIENCE
AND SOCIETY.
THESE LETTERS OF INTEREST ARE
SHORT, THREE PAGES IN LENGTH,
AND APPLICANTS CAN REQUEST UP TO
$150,000 IN FUNDING FOR PROJECTS
OVER 18-MONTH PERIOD.
I CAN DROP A LINK INTO THE CHAT
AS WELL.
HERE.
THERE IT GOES.
IT TAKES A MOMENT TO POST.
THE SECOND UPDATE IS THAT THE
2024-2025 CIVIC SCIENCE FELLOW
POSITIONS ARE OUT FOR OPEN CALL
RIGHT NOW SO IF THERE ARE ANY
TRAINEES THAT ARE INTERESTED IN
CIVIC SCIENCE WORK, WORK THAT
HELPS BRIDGE NEUROSCIENCE AND
SOCIETY, PUBLIC ENGAGEMENT,
THERE ARE SEVERAL CALLS FOR
THOSE POSITIONS.
THE DANA FOUNDATION IS
SPONSORING THREE FELLOW
POSITIONS, ONE ON PSYCHEDELICS
ACTUALLY, PUBLIC ENGAGEMENT, AND
STAKEHOLDER ENGAGEMENT AROUND
PSYCHEDELICS, WITH BERKELEY
CENTER FOR SCIENCE OF
PSYCHEDELICS.
ANOTHER ONE AT U.C. IRVINE
THAT'S OPEN AS WELL, EXPLORING
ETHICAL AND SOCIETAL
IMPLICATIONS OF SLEEP
NEUROSCIENCE WITH THE SANTA ANA
COMMUNITY.
A THIRD ONE WITH NEURAL MATCH,
THIS IS GOING TO BE FOCUSED ON
INTERSECTION OF A.I. AND I
ENCOURAGE YOU TO SHARE WITH
STUDENTS AND TRAINEES ABOUT
THESE OPPORTUNITIES.
THEY ARE LOOKING FOR GREAT
APPLICANTS.
AND BRAIN AWARENESS WEEK, DANA
FOUNDATION HAS SPONSORED BRAIN
AWARENESS WEEK SINCE THE EARLY
1990s, AND WE'RE PARTNERING
WITH INTERNATIONAL BRAIN
RESEARCH ORGANIZATION, AND THE
FEDERATION OF EUROPEAN
NEUROSCIENCE SOCIETIES TO HELP
INCREASE EDUCATION AND OUTREACH
IN NEUROSCIENCE, A FEW THINGS
THAT MIGHT BE OF INTEREST TO
THIS GROUP.
>> WONDERFUL, THANK YOU VERY
MUCH.
SAMEER, ANYTHING?
>> YEAH, TWO QUICK THINGS.
THE FIRST BIT ABOUT VARIOUS
REGULATORY ISSUES, AND I'VE BEEN
VERY HAPPY TO EXPERIENCE IN THE
LAST SEVERAL MONTHS INCREASED
INTEREST FROM THE GROWING
DEVICE-RELATED STAFF AT FDA, AN
INTEREST IN ENGAGING IN TERMS OF
DEALING WITH A LOT OF ISSUES
REGARDING HOW TO REGULATE
PRODUCTS IMPLANTS AS WELL AS
DEVICES INTRAOPERATIVELY, TWO
WORKSHOPS, THERE'S NO WEB
PRESENCE YET, SO IF YOU ARE
INTERESTED LET ME KNOW.
SOME OF YOU ARE ALREADY SPEAKING
AT THEM.
THANK YOU.
AND ANYONE WHO WANTS TO ATTEND
IN PERSON OR REMOTELY, ATTACHED
TO THE ASSM MEETING.
JUST SAY THE LETTERS, DON'T
PRONOUNCE THAT.
EVERY-OTHER-YEAR MEETING,
BEGINNING OF JUNE, 1-4 IN
NASHVILLE.
AND THERE'S A PRE-MEETING THE
DAY BEFORE ON MAY 31, FULL DAY
MEETING ON PSYCHIATRIC
NEUROSURGERY, A SESSION ON
NEUROETHICS, AND FIRST DAY OF
THE MEETING, SATURDAY JUNE 1, IN
THE MORNING, HALF DAY WORKSHOP,
WITH FDA AND OTHER PEOPLE AS
WELL AS PEOPLE FROM NIH TO NIMH
AND NINDS, AND OF COURSE
CLINICIANS AND SCIENTISTS, ABOUT
NOVEL ELECTRODES USED
INTRAOPERATIVELY, HOW DO WE DEAL
WITH REGULATORY QUESTIONS.
IF YOU'RE INTERESTED IN EITHER,
WE'RE FINALIZING.
WE'RE MEETING IN THE HOTEL
ITSELF WITH ZOOM OPTIONS FOR
PEOPLE THAT DON'T WANT TO
TRAVEL.
>> THANK YOU VERY MUCH.
WINSTON?
>> NOT QUITE READY.
I GUESS ONE KEY ONE IS JUST SOME
CONVERSATIONS WITH JOE AND OTHER
PEOPLE ABOUT TRYING TO BRIDGE
SOME GAPS BETWEEN THE CLINICAL
PRACTICE AND THE BRAIN-BASED
SPECIALTIES, NEUROLOGY,
PSYCHIATRY, NEUROSURGERY,
CLINICAL PSYCHOLOGY, SIMILAR
CONVERSATIONS IN THE TRADITIONAL
NEUROETHICS, NEUROTECHNOLOGY
SPACE, AN AREA WHERE THERE'S A
LOT OF INTEREST IN TRYING TO
THINK ABOUT COMMON ISSUES,
DISCUSSIONS INCLUDING TODAY
ABOUT SOME THEMES POP UP IN
SIMILAR PLACES, WHETHER
NEUROMODULATION, PSYCHEDELICS,
PSYCHIATRIC ILLNESS, AND SO
FORTH.
THAT'S AN AREA THAT WE'RE
INTERESTED TO EXPLORE AND WE'LL
BE DISCUSSING IN OUR ETHICS LAW
AND HUMANITIES COMMITTEE.
>> GREAT.
THANK YOU.
JIM?
>> I WANT TO THANK THE SPEAKERS
FOR ALL THEIR INTERESTING
THOUGHT-PROVOKES TALKS TODAY.
FOOD FOR THOUGHT FOR SEVERAL
NEW MEETINGS.
VARIOUS THINGS ONGOING, KAREN
AND I ARE MEMBERS OF A NATIONAL
ACADEMY WORKING GROUP ON
ENGAGING SCIENTIST IN SOUTHEAST
ASIA.
IT WILL BE DONE RELATIVELY SOON
TALKING ABOUT INNOVATION,
DIFFERENT COUNTRIES AND I'LL
MAKE SURE IT'S SHARED.
THANK YOU.
>> THANKS, JIM.
SYD?
>> THANKS.
LET'S SEE.
I'VE BEEN DOING A LOT OF
INTERVIEWS WILL NEUROLINK,
PEOPLE KEEP CALLING TO ASK WHAT
I THINK, WHICH ISN'T MUCH.
AND I HAVE A SMALL BOOK COMING
OUT WITH CAMBRIDGE, LATER THIS
MONTH, ON BRAIN DEATH, AND THEN
ANOTHER LITTLE BOOK ON RESEARCH
WITH NON-HUMAN PRIMATES IN
ANOTHER MONTH OR TWO.
>> GOOD FOR YOU.
AMY, DO YOU HAVE ANYTHING TO ADD
FOR THE GROUP?
>> NO, I WANT TO THANK YOU FOR
INVITING ME TO JOIN, I'M EXCITED
TO BE PART OF IT.
IT WAS A GREAT MEETING.
I LOOK FORWARD TO CONTINUING
ENGAGE.
WE'RE ADVERTISINGS FOR A POSTDOC
POSITION IF YOU KNOW ANYONE WHO
IS INTERESTED SEND THEM OUR WAY.
>> GREAT TO HAVE YOU TOO.
JEN?
>> YEAH, A BIT OF A SURPRISE,
THANK YOU FOR TAKING ME LAST,
GIVING ME TIME TO THINK ABOUT
IT.
THANK YOU ALL.
THIS IS MY FIRST OFFICIAL NEWG
MEETING, APPRECIATED THE
PRESENTATIONS AND CONVERSATIONS
AROUND THAT.
I WEAR A COUPLE HATS.
I'M WITH THE NEUROTECH NETWORK,
BUT YOU MAY KNOW ME, LIVE WITH A
SPINAL CORD INJURY, AND THE
NORTH AMERICAN SPINAL CORD
INJURY CONSORTIUM IN PARTNERSHIP
WITH THE UNIVERSITY OF BRITISH
COLUMBIA PUBLISHED A PAPER THIS
YEAR ABOUT DATA SHARING AND
PEOPLE'S PERSPECTIVES ON DATA
SHARING.
THAT MIGHT BE SOMETHING OF
INTEREST TO THIS GROUP.
JUST TO SEE ANOTHER PERSPECTIVE
FROM A DIFFERENT POPULATION.
ALSO, NEXT MONTH IN PARTNERSHIP
WITH NEUROMOTORRIC, WE'RE
HOSTING A FREE WEBINAR ON
ADVOCACY AND NEUROMODULATION, I
PUT THE LINK IN THE CHAT.
THAT MIGHT BE OF INTEREST TO
THIS GROUP.
THANKS.
>> GREAT.
THANK YOU.
GREAT TO HAVE YOU ON BOARD.
NITA?
ANY UPDATES.
>> NOTHING MAJOR TO REPORT OTHER
THAN I DON'T KNOW IF EVERYBODY
SAW OR NOT BUT IN DECEMBER THE
UNESCO MEMBER COUNTRIES VOTED TO
MOVE FORWARD DEVELOPING ETHICS
OF NEUROTECHNOLOGY, WHICH SHOULD
KICK OFF PROBABLY IN MARCH I
THINK THE WORK OF CONVENING
EXPERT PANEL THAT WILL CONSIST
OF 24 ACADEMICS, FOR THE FIRST
PART OF THE PROCESS, THAT SHOULD
GO THROUGH AUGUST, AND THEN
WE'LL CONTINUE WITH THE
POLITICAL PROCESS AFTER THAT.
I'VE PUT A LINK HERE FOR
NATIONAL ACADEMIES WORKSHOP IN
MARCH WHICH IS EXPLORING
BIODIRECTIONAL RELATIONSHIP
BETWEEN ARTIFICIAL INTELLIGENCE
AND NEUROSCIENCE WHICH WILL BE A
VALUABLE WORKSHOP AND ENCOURAGE
EVERYBODY TO ATTEND THAT
OBVIOUSLY AS WE HEARD TODAY
CONVERGENCE THERE IS RAISING
NOVEL QUESTIONS AND IS RAPIDLY
CHANGING THE FIELD.
HIGHLY COMMEND THAT WORKSHOP TO
EVERYBODY.
>> WONDERFUL.
I THINK WE'RE ABOUT AT THE END.
I WANT TO REITERATE SOME THANKS
THIS MORNING FOR NINA HSU,
SASKIA HENDRIKS, KRISTIN DUPRE
AND LOGISTICS.
THANK YOU, JOHN, FOR LEADING US
OFF AND BEING HERE TODAY, WALTER
TOO.
AND THANK YOU, NITA, FOR
CO-CHAIRING WITH ME.
I TURN IT BACK TO ANDREA.
>> THANKS, CHRISTINE.
ADDING MY THANKS TO YOU AND TO
NITA AND ALL OUR GUESTS AND
PANELISTS, GREAT CONVERSATIONS
THAT WE'LL BE ABLE TO KEEP
GOING.
REMINDER THIS GROUP DOES NOT
MEET IN MAY SO WE'LL SEE YOU
AGAIN IN AUGUST.
YOU'LL BE HEARING FROM NINA AND
WE'LL BUILD TOWARDS THAT MEETING
AGAIN.
THANKS VERY MUCH FOR YOUR
ATTENDANCE AND YOUR ENGAGEMENT.
>> AND FINAL WORD OF THANKS TO
EVERYBODY.
GREAT DAY OF DISCUSSION.
YOU BROUGHT A LOT OF ISSUES THAT
HAVE BEEN SWIRLING AROUND INTO
NOT ONLY BETTER FOCUS BUT ALSO
WE GOT A LOT OF MORE THINKING TO
DO.
THANKS SO MUCH FOR ALL THAT.
>> WE'LL CLOSING MEETING.
THANKS, JOHN. 6657 04:13:48,146 THANKS, EVERYONE.