WELCOME BACK, EVERYONE TO DAY 2
OF OUR BRAIN NEUROETHICS WORKING
GROUP WORKSHOP ON CONTINUING
TRIAL RESPONSIBILITIES.
I WANT TO ESPECIALLY EXTEND A
WARM WELCOME TO OUR WORKING
GROUP CO CHAIRS DOCTORS GRADEY
ALONG WITH OUR SPEAKERS AND
PANELISTS, MANY OF WHOM JOINED
US YESTERDAY AND JOINING US
AGAIN TODAY.
I AM NINA SHU, I AM THE
COMMITTEE BRAIN ETHICS WORKING
GROUP AND ACTING CO LEAD FOR THE
NIH BRAIN INITIATIVE.
AS MOST OF YOU MAY KNOW THE
NEUROETHICS WORKING GROUP IS NOT
A FORMAL ADVISORY GROUP, IT IS A
WORKING GROUP OF THE ADVISORY
COUNCILS AND CENTERS AND
INSTITUTEDS THAT PARTICIPATE IN
THE BRAIN INITIATIVE AND WAS
ESTABLISHED BECAUSE OF THE NEED
FOR INPUT ON NEUROETHICS
CONSIDERATIONS RELATED TO
RESEARCH SUPPORTED THROUGH THE
BRAIN INITIATIVE.
THE GROUP DELIBERATES ON ETHICAL
QUESTIONS THAT AM CAN UP IN THE
CONTEXT OF BRAIN RESEARCH AND
THOSE DISCUSSIONS HAVE INFORMED
AND SERVED AS THE FOUND FOR THIS
WORKSHOP.
SO JUST A FEW ZOOM OWS KEEPING
THINGS BEFORE WE GET STARTED.
AS A REMINDER THIS VIRTUAL
WORKSHOP IS BEING VIDEOCAST LIVE
AND IN THE PUBLIC DOMAIN AND THE
RECORDING WILL BE ARCHIVED FOR
LATER VIEWING ON THE NIH AND THE
BRAIN WEBSITE.
DURING PRESENTATIONS FOR
PANELISTS, PLEASE MUTE YOUR LINE
AND TURN OFF YOUR VIDEO WHEN
YOU'RE NOT SPEAKING.
THIS IS HELPFUL FOR THE
VIDEOCAST.
AND THEN DURING DISCUSSIONS,
PANELISTS ARE ENCOURAGED TO TURN
ON YOUR VIDEO DURING THE
DISCUSSION AND TO USE IT IS
RAISE HAND OPTION IF YOU HAVE
QUESTIONS AND WE WILL CALL ON
YOU TO UNMUTE YOURSELF.
FOR ATTENDEES, I WANT TO CALL
YOUR ATTENTION TO THE Q&A BOX,
SO ATTENDEES CAN POST QUESTIONS
IN THE ASK QUESTION FEATURE.
YOU ALSO HAVE THE OPTION TO ASK
THESE QUESTIONS ANONYMOUSLY AND
THERE'S THE OPTION TO UP VOTE
OTHER QUESTIONS THAT YOU SEE
APPEAR IN THE QUESTION BOX.
IF ANYONE IS HAVING ANY
TECHNICAL PROBLEMS PLEASE
CONTACT GREG RICHARDS WHO WILL
BE ABLE TO ASSIST AND YOU ALSO
INCLUDE HIS CONTACT INFORMATION
IN THE CHAT.
I KNOW EVERYBODY IS REALLY BUSY
AND WE VERY MUCH APPRECIATE YOUR
TIME AND YOUR INPUT BOTH
YESTERDAY AS WELL AS TODAY.
AND NONE OF THIS COULD HAPPEN
WITHOUT THE REALLY FABULOUS TEAM
THAT WE HAVE HERE AT NIH.
I ESPECIALLY WANT TO THANK THE
WORKSHOP PLANNING COMMITTEE FOR
THIS GROUP WHICH INCLUDED
PROGRAM AND REVIEW STAFF ACROSS
SEVERAL OF THE BRAIN INSTITUTES
AND CENTERS.
DR. SSKIA HENDRIKs AND
DR. JOHN NGAI, FOR HIS SUPPORT
OF NEUROETHICS.
WITH THAT SAID, I THINK BEFORE
WE GET STARTED FOR DAY 2, WE
WILL DO A BRIEF RECAP FOR THE
REALLY RICH PRESENTATIONS AND
DISCUSSIONS WE HEARD YESTERDAY.
SO YOU WILL SEE MY FACE FOR A
LITTLE BIT LONGER WHILE I GIVE
THIS RECAP.
SO AS MOST OF YOU MAY KNOW THIS
WORKSHOP IS STRUCTURED AS A
SERIES OF PROGRESSIVE PANELS
THAT EACH BUILD UPON THE 1
BEFORE.
SO BEFORE WE MOVE INTO THE
SESSIONS FOR TODAY, FOR THOSE
WHO MAY HAVE MISSED YESTERDAY,
OR WANT A QUICKER REFRESHER, I
WANTED TO HIGHLIGHT KEY POINTS
THAT WERE RAISED DURING
YESTERDAY'S PANELS, AS WELL AS
TO INCORPORATE THE POINTS THAT
WERE RAISED IN THE PREMEETING
DIALOGUES THAT FORMED THIS
WORKSHOP.
NEXT SLIDE, PLEASE.
SO FIRST A QUICK REMINDER OF OUR
OVERARCHING WORKSHOP GOAL, WE'RE
AIMING TO BRING TOGETHER THE
RELEVANT STAKEHOLDERS TO DISCUSS
REASONABLE EXPECTATIONS FOR
RESEARCH RELATED CARE PLANS THAT
COULD EVENTUALLY INFORM BEST
PRACTICES FOR THE RESEARCH
COMMUNITY.
WE'RE HOPING THIS MIGHT BE
THROUGH POTENTIALLY THROUGH OUR
PAPER.
AND YESTERDAY WE HEARD SEVERAL
POWERFUL--POWERFUL PERSPECTIVES
FROM THOSE WHO WERE LIVING WITH
THESE NEEDS, AND YET THE STATE
OF THE FIELD INDICATES THAT
THERE IS SOME HETEROGENERATED
AITY AND THE EXTENT TO STUDIES
PLAN FOR POST TRIAL RESEARCH
RELATED CARE NEEDS AND WHAT
THOSE PLANS ENTAIL.
THESE NEEDS MIGHT OCCUR AFTER A
TRIAL ENDS AND FOR INSTANCE,
BEFORE THE DEVICE AS BEEN
APPROVED FOR CLINICAL USE, IF
THE DEVICE DOESN'T GET APPROVED
FOR CLINICAL USE, IF THE DEVICE
MANUFACTURE DISCONTINUES THE
PRODUCT, OR THE COMPANY GOES OUT
OF BUSINESS, AND IF THE DEVICE
IS,A PROVED FOR CLINICAL CARE
BUT THE FORMER PARTICIPANT MAY
NOT HAVE INSURANCE COVERAGE.
AND AND THIS INSTANCE HAS
RELEVANCE WHEN CONSIDERING THE
DIVERSITY OF PARTICIPANT WHO IS
ARE RECRUITED FOR THESE STUDIES.
THERE ARE ADDITIONAL
CONSIDERATIONS FOR EXAMPLE, IF
THE PI MOVES INSTITUTIONS OR IF
THERE'S A LEADERSHIP CHANGE AT
AN INSTITUTION AND THESE ARE
SOME CASES WHERE WE HAVE
CONTINGENCIES.
NEXT SLIDE, PLEASE.
OUR PANELISTS INDICATED
YESTERDAY IN PANEL 1, WE
EXAMINED WHAT NEED STUDY
PARTICIPANTS MAY HAVE IN
RELATION TO THEIR TRIAL
PARTICIPATION AFTER A TRIAL ENDS
AND THEY VOICED SOME OF THESE
FOLLOWING NEEDS THAT ARE RELATED
TO THAT.
FIRST CONTINUED ACCESS TO AN
ALREADY IMPLANTED DEVICE,
PARTICULARLY IF THE PATIENT IS
BENEFITING.
ANOTHER NEED THAT WAS FOLLOW UP
CARE AND DEVICE SUPPORT AND
MAINTENANCE, THIS CAN INCLUDE
THINGS LIKE HAVING ACCESS TO
SPECIALIZED CLINICIANS, AND THIS
COMPONENT ALSO INCLUDES THINGS
LIKE HAVING UPTO DATE
INFORMATION REGARDING THEIR
MEDICAL DEVICE, FOR EXAMPLE IF
THE MRI IS COMPATIBLE.
ANOTHER NEED TO FOLLOW UP CARE
IS HAVING COMPATIBLE HARDWARE
AND REPLACEMENT PARTS AS WELL AS
ASSOCIATED SURGERY TO PERFORM
THOSE REPLACEMENTS OR HAVE THOSE
REPLACEMENTS.
ANOTHER NEED IS EMERGENCY CARE
DUE TO SIDE EFFECTS OR DEVICE
COMPLICATIONS, AND WE ALSO HEARD
ABOUT THE ACCORD NATION OF CARE
SO THIS NEED CAN INCLUDE THINGS
LIEB HELPING PATIENTS TO
NAVIGATE ADMINISTRATIVE NEEDS,
NAVIGATE INSURANCE SYSTEMS,
HELPING PATIENTS TO FIND
ADDITIONAL CLINICAL
OPPORTUNITIES OR TREATMENT
OPTIONS AFTER A STUDY HAS
COMPLETED TO HELP PATIENTS
NAVIGATE RECEIPT OF CARE FOR
OLDER VERSIONS OF A MEDICAL
DEVICE, INCLUDING THOSE THAT MAY
NOT BE FDA APPROVED.
NEXT SLIDE, PLEASE.
SOME ADDITIONAL NEEDS WE HEARD
ABOUT INCLUDED DEVICE
EXPLANTATION WHICH COULD BE
ELECTIVE OR DUE TO MEDICAL
INDICATION.
WE HEARD FROM PANELISTS THAT
EXPLANTATION, SO CASES OF
EXPLANTATION, IT CAN BE POSSIBLE
TO REQUEST FUNDS FOR
EXPLANTATION BUT THIS ISN'T
CONSISTENTLY DONE AND NOT ALL
INVESTIGATORS MAY DO THIS,
ANOTHER PANELIST NOTED THAT IT
CAN BE HARD TO COME TO A QUICK
OR RAPID DECISION ABOUT
EXPLANTATION, SO THERE'S A NEED
TO BE COMPASSIONATE BUT TO ALSO
HAVE BOTH POTENTIALLY A DECISION
TREE AS WELL AS DECISION PLANS
FOR EXPLANTATION.
WE HEARD ABOUT DEVICE
REPLACEMENT REQUIRING HARDWARE
AND SURGERY COSTS ALOS ANGELES
AS PSYCHOLOGICAL SUPPORT FOR
PARTICIPANTS WE HEARD ABOUT
REASONABLE OPTIONS FOR PATIENTS,
AS WELL AS CLARITY ABOUT THE
FUTURE ACCESS TO CARE AND
ASSOCIATED OUT OF POCKET
EXPENSES THAT PARTICIPANTS MAY
BEAR AND WE ALSO HEARD ABOUT THE
ACCESSIBILITY OF RESEARCH
RECORDS FOR NEW PROVIDERS TO
HELP PROVIDE DOCUMENTATION OF
DEVICE SETTINGS, TO HELP
RECONCILE CLINICAL INFORMATION
WITH TRIAL INFORMATION AND 1 WAY
FOR THIS, MAY BE THROUGH A
REGISTRY OR DATABASE AS 1
POSSIBLE OPTION.
NEXT SLIDE, PLEASE EMPLOY SOME
OF THE ADDITIONAL CONSIDERATIONS
FROM PANEL 1, THERE'S THE
CONSIDERATION TO BE ABLE TO HAVE
DIVERSE PARTICIPANTS ENROLLED.
THAT MAY MEAN REQUIRING
FACILITATING MORE POST TRIAL
NEEDS GENERALLY TO BE ABLE TO
REDUCE OR MITIGATE THE FINANCIAL
BURDEN RELATED TO TRIAL
PARTICIPATION.
WE HEARD ABOUT CONSIDERING
PATIENT INVOLVEMENT EARLY ON IN
TRIAL DESIGN, INCLUDING
IDENTIFYING AND PLANNING FOR
POST TRIAL NEEDS.
WE ALSO HEARD ABOUT CONSIDERING
PATIENT'S LIFETIME CARE NEEDS AS
PART OF THE TRIAL DESIGN FOR
EXAMPLE, THROUGH A RECHARGEABLE
BATTERIES TO HELP LIMIT THE
NUMBER OF PROCEDURES THAT
PARTICIPANTS MY NEED TO UNDERGO.
WE ALSO HEARD ABOUT THE NEED FOR
LONG-TERM RESEARCH TO BE ABLE TO
STUDY PATIENT OUTCOMES AS WELL
AS DEVICE SAFETY AND WE HEARD
ABOUT THE NEED OR CONSIDERATION
FOR ADEQUATE KEEP INFORMED
CONSENT.
NEXT SLIDE, PLEASE.
I JUST WANT TO HIGHLIGHT SOME OF
THE QUOTES THAT WE HEARD
YESTERDAY PARTICULARLY FROM OUR
PATIENT PARTICIPANTS WHO ARE
PART OF THE PANEL.
FOR ME IT'S NOT AN EXPERIMENT,
IT'S A WAY TO KEEP ME ALIVE, WE
KNOW THAT THIS WORKS.
THAT WAS FROM BRANDY ELLIS, FROM
MISS JEN FRENCH, I HAVE BEEN
REPARALYZED 4 TIMES WHEN MY
IMPLANT HAS FAILED BUT SINCE MY
CLINICAL TRIAL IS ONGOING, I
COULD BERIA IMPLANTED AND LOSS
OF SPHUNKZ A WORRY FOR PANE
PATIENT-PARTICIPANTS.
AND FROM TYLER HAJJAR, AT THE
TIME THE TRIAL STARTED, THE
OPTIONS FOR ME WERE TRY THIS OR
DEATH, I WASN'T THINK BEING THE
FUTURE, NOW, 3 YEARS IN WITH A
BATTERY THAT IS SAID TO LAST 15
YEARS I'M THINKING ABOUT WHAT
WILL HAPPEN 20 YEARS FROM NOW.
AND FROM JAMES MAHONY, WHO SAID
WHEN THESE STUDIES ARE OVER,
THEY'RE NOT OVER.
SO WHEN WE SHIFTED TO PANEL 2
WHICH ASKED WHAT DO STAKEHOLDER
PROSVIED AND WHAT COULD THAT
PROVIDE, WE HEARD FROM A VARIETY
OF STAKEHOLDERS INCLUDING DEVICE
MANUFACTURES, INVESTIGATORS,
INSURERS, INSTITUTION
ADMINISTRATORS AS WELL AS NIH
PROGRAM STAFF, FOR THEIR
PERSPECTIVES ON WHAT THEIR
RESPECTIVE GROUPS CURRENTLY
PROVIDE.
I WANT TO NOTE THAT WHAT WE
HEARD WAS THAT ALL STAKEHOLDERS
DO COVER POST TRIAL NEEDS.
NEEDS THAT ARE GENERALLY COVERED
FOR THINGS LIKE EMERGENCY CARE
RELATING TO SIDE EFFECTS OR
DEVICE COMPLICATIONS, THIS WAS
GENERALLY COVERED BY PATIENTS
EAS' HEALTH INSURANCE.
ANOTHER NEED THAT WAS GENERALLY
COVERED WAS ROUTINE MEDICAL CARE
THAT WAS RELATED TO THE MEDICAL
CONDITION, FOR EXAMPLE, THROUGH
CLINICIAN APPOINTMENTS OR
SPECIALIST APPOINTMENTS THAT A
PATIENT WOULD BE SEEN ALSO
COVERED BY HEALTH INSURANCE.
AND EXPLANTATION DUE TO MEDICAL
INDICATION WAS ALSO GENERALLY
COVERED BY PATIENT HEALTH
INSURANCE.
AND OTHER POST TRIAL RESEARCH
CARE NEEDS WHAT WE HEARD WAS
THAT THESE WERE NOT CONSISTENTLY
COVERED.
NEXT SLIDE, PLEASE.
AND THERE WERE A NUMBER OF
FACTORS THAT DETERMINED
DECISIONS ON COVERAGE OR
PROVISION OF POST TRIAL CARE
NEEDS.
ONE WAS SUCCESS OF THE DEVICE,
SO WE HEARD THAT FOR EXAMPLE,
WHETHER AN FDA DEVISE IS
APPROVED, A REVIEW OF PUBLISHED
EVIDENCE FOR THE SUCCESS OF THE
DEVICE WOULD EXAMINE THINGS LIKE
QUALITY, STRENGTH AND
IMPROVEMENT OF MEANING PATIENT
CENTERED OUTCOMES AND THIS WOULD
HELP DETERMINE COVERAGE FOR THAT
DETERMINE NATION OF NEED BETWEEN
A FRIEL ENDS AND FDA APPROVAL,
THIS INSTANCE WILL BE EVALUATED
MORE ON A CASE BY CASE BASIS.
ANOTHER FACTOR DETERMINING
COVERAGE, WAS WHETHER THE
PATIENT HAS INSURANCE AND WHICH
INSURANCE.
THIS LEADS TO THINGS LIKE
WHETHER THE DEVICE IS APPROVED
FOR FDA CLINICAL USE AND FOR
WHAT INDICATION AND WHETHER THE
RESEARCH DATA IS SUFFICIENT TO
QUALIFY FOR CMS OR PRIVATE
HEALTH INSURANCE COVERAGE.
WE HEARD HERE SOME
CONSIDERATIONS FROM PAYERS THAT
MAYBE BASED ON MAKING DECISIONS
FOR HOW TO DISTRIBUTE FUNDS IN A
POPULATION.
AND HERE THE QUESTION MAY NOT
JUST BE ABOUT EFFICACY BUT ALSO
ABOUT COST ASSOCIATED WITH
DURATION, LONG-TERM OUTCOMES AND
ONGOING CARE AS WELL AS REPEAT
SURGERIES.
SO THE COVERAGE MAY DEPENTINE
REGIMEN ON THE PROJECTED COST
AND HOW THIS FOLDS INTO THE
AVAILABLE FUNDS FOR THE GENERAL
POPULATION.
WE ALSO HEARD THAT ANOTHER
FACTOR DETERMINING COVERAGE MAY
BE FINANCIAL RESOURCES AND
LEADERSHIP SUPPORT IN PERSONAL
ORGANIZATIONS THAT ARE INVOLVED
IN FACILITATING POST TRIAL CARE.
WE ALSO HEARD ABOUT WHETHER
POTENTIALLY AVAILABLE MECHANISMS
ARE UTILIZED.
MANY OF THESE MAY REQUIRE
ADVANCE PREPARATION AT THE START
OF THE STUDY RATHER THAN AFTER
THE TRIAL ENDS.
AND WE ALSO HEARD ABOUT THE
ABILITY OF PATIENTS TO
COORDINATE CARE AS A FACT OF
DETERMINING COVERAGE.
ONE OF OUR PANELISTS SPOKE TO
THE IDEA OF CLINICAL TRIAL
COORDINATORS BEING A CAREER PATH
TO HELP FACILITATE THIS ABILITY
OF PATIENTS TO COORDINATE CARE.
NEXT SLIDE, PLEASE.
SO SOME OF THE ADDITIONAL
CONSIDERATIONS FROM OUR FIRST 2
PANELS THEY THINK TO HELP DEE US
UP OR TODAY'S SESSION IS THAT
WHAT WE COLLECTIVELY HEARD WITH
THAT ALL STAKEHOLDERS SHARE
GOALS FOR THE BENEFIT OF THE
PATIENTS AND THAT MEANS THERE'S
A SHARED BURDEN AND SHARED
OPPORTUNITY IN HOW WE CAN BEST
ADDRESS THOSE POST CARE NEEDS.
AND NEGOTIATIONS ARE CURRENTLY
MADE ON A CASE BY CASE BASIS IN
MANY INSTANCES AND MAY BE MADE
ADHOC WHEN THE CARE IS NEEDED
WHEN A NEED EMERGES OR ARISES.
SO AN ADDITIONAL CONSIDERATION
HERE IS A NEED TO CREATE POST
TRIAL CARE PLANS BEFORE THE
START OF A TRIAL AND BROADLY
SPEAKING TO BE ABLE TO GENERATE
ETHICALLY GROUNDED BEST
PRACTICES AS WELL AS CONCRETE
PRAGMATIC STRATEGIES AND OVERALL
WE WOULD LIKE TO ENCOURAGE THE
GROUP TO CONSIDER BENEFITS FOR
INDIVIDUAL PARTICIPANTS VERSUS
THE OVERALL TRIAL RESULTS
INCLUDING BOTH CLINICAL AND
PATIENT CENTERED OUTCOME
MEASURES.
SO I THINK HOPEFULLY THIS IS A
WAY TO PRIMEUS AND SORT OF GIVE
US SOME FOUNDATION ON WHICH TO
BASE TODAY'S 2 SESSIONS.
AND I THINK WITH THAT, WE CAN
TAKE DOWN THESE SLIDES AND I AM
GOING TO TURN IT OVER TO
DR. KRISTIN GRADE SKPE BAKUGAN
DR. HENDRIKs, WHO WILL BE
CO-MODERATING PANEL 3.
>> HELLO, EVERYBODY AND WELCOME
TO THE SECOND DAY OF THIS
WORKSHOP ON WORKING ON NEUROEGHT
KICKS RESPONSIBILITIES, GREAT
SUMMARY OF YESTERDAY'S
DISCUSSION.
SO PANEL 3 WE ARE VERY EXCITED
ABOUT BECAUSE WE WILL COVER A
QUESTION OF WHAT SHOULD BE THE
MINIMUM IN TERMS OF RESEARCH
RELATED CARE NEEDS THAT WE
SHOULD BE TRYING TO FACILITATE
AND IMPLANTING NEURAL DEVICE
TRIALS, WHEREAS PANEL 2
YESTERDAY WAS ABOUT
[INDISCERNIBLE], THIS PANEL IS
MORE ABOUT WHAT OUGHT TO BE
PROVIDED, THEN BESIDES
DISCUSSING WHAT THE MINIMUM IS,
WE WOULD LIKE TO ASK THE
PANELISTS TO THINK ABOUT WHEN
STAKEHOLDERS WOULD HAVE
RESPONSIBILITIES TO MAYBE
PROVIDE TO FACILITATE MORE THAN
THE MINIMUM.
FOR EXAMPLE, MAYBE IF IT'S A
TRIAL INVOLVING CHILDREN, WE
WOULD NEED TO DO SOMETHING
ADDITIONAL AS COMPARED TO A
TRIAL WITH ADULTS.
THAT'S JUST AN EXAMPLE.
SO I WOULD LIKE TO ENCOURAGE THE
PANELISTS AS FAR AS POSSIBLE
CONSIDER ALL THE NEEDS THAT WE
LEARNED ABOUT IN PANEL 1
YESTERDAY.
AND TO MAKE THE DISCUSSION ABOUT
HOW BEST TO ADDRESS THOSE NEEDS
FOR THE FORUM WHICH WILL TAKE
PLACE THIS AFTERNOON AFTER THE
BREAK.
SO IN THIS SESSION, WE WANT TO
REALLY FOCUS ON WHAT WE SHOULD
BE PROVIDING, WHERE WE AS THE
SHARED COMMUNITY OF PROFESSIONAL
STAKEHOLDERS INVOLVED IN THIS
TRIAL.
I FORGOT TO INTRODUCE MYSELF, MY
NAME IS SASKIA, HENDRIKs, I AM
NIH DEPARTMENT OF BIOETHICS AND
I ALSO WORK AS A FAC ALL THEY
NEUROETHICS CONSULTANT AT NIAIDS
AND WITH ME TODAY IS MY CO-CHAIR
KRISTIN GRADEY.
>> I'M CHRISTINE GRADEY, AND I'M
ALSO THE CHAIR OF THE DEPARTMENT
OF BIOETHICS AT THE NIRE
LYNNICAL CENTER.
AND WITH SASKIA HENDRIKs, I
WILL CO MODERATE THIS PANEL AS
SHE'S POINTED OUT, IT WILL BE A
REALLY IMPORTANT PANEL AND WE
ARE VERY LUCKY TO HAVE A NUMBER
OF REALLY GREAT PANELISTS.
SO I WILL START BY INTRODUCING
OUR FIRST PANELISTS, TO SPEAK
WITH US AND THAT'S TRACEY
DIXON-SALAZAR, A NEUROSCIENTIST,
A GENETICIST AND A PATIENT
ADVOCATE, HER DESIRE TO GET HER
Ph.D. WAS INSPIRED BY HER
DAUGHTER SAN FRANCISCO VARMIS
KNOWA WHO GEPPED INTRACTABLE
SEIZURES AT THE AGE OF 2 WHICH
ENDED UP PROGRESSING INTO A
SYNDROME BY AGE 5.
SHE CURRENTLY SERVING AS THE LGS
FOWBDATION.
THANK YOU DR. DIXON-SALAZAR.
>> THANK YOU SO MUCH FOR HAVING
ME, I APPRECIATE BEING HERE AND
I REALLY APPRECIATED THE
CONVERSATION.
I DON'T THINK I'M GOING TO ADD
ANYTHING TERRIBLY NEW TO THE
CONVERSATION.
I'M HOPING TO REFRAME IT IN MY
TALK AND HOPEFULLY YOU CAN SEE
MY SLIDES, AND SEE MY SCREEN.
>> OKAY, GREAT.
>> YES WE CAN.
>> ALL RIGHT, GREAT.
SO THANK YOU FOR THAT GREAT
INTRODUCTION AS WELL, I
SHOULDN'T TELL YOU ABOUT OUR
JOURNEY AS I TRY TO REFRAME
EVERYTHING I HEARD, I FEEL LIKE
EVERYTHING'S BEEN SAID BUT MAYBE
IT COULD USE A LITTLE BIT OF A
SPIN, SO MY DAUGHTER SAN
FRANCISCO VAN APPROVAL FROM SBA
BORN TYPICALLY A HEALTHY
DEVELOPING, I WAS A YOUNG 23
YEAR-OLD MOM AND SHE DEVELOPED
COMPLETELY NORMALLY UNTIL THE
AGE OF 2 WHEN OUT OF THE BLUE
SHE HAD HER FIRST SEIZURE.
AND VERY QUICKLY SHE HAD A
COUPLE MORE SEIZURES AND THEN
SHE WENT 6 MONTHS WITHOUT HAVING
THEM AND THEN THEY CAME BACK AT
THE AGE OF 3.
SHE WAS DIAGNOSED AT THAT TIME
WITH IDIO PATHIC/CRYPTO GENIC
INTRACTABLE EPILEPSY.
SHE WAS HAVING HUNDREDS OF
SEIZURES A DAY AND WE STARTED TO
SEE DELAYS IN HER DEVELOPMENT
AND IT COMPLETELY DERAILED OUR
LIVES.
SEIZURES TOOK OVER OUR LIVES, A
GOOD DAY WAS 5 TO 10 SEIZURES, A
BAD DAY WAS HUNDREDS OF
SEIZURES.
TOO MANY TO COUNT.
WE NEVER KNEW WHAT WE WERE GOING
TO GET FROM DAY-TO-DAY AND OUR
LIFE BECAME FOR SEIZURES AND
PLANNING FOR THE AFTERMATH OF
SEIZURES WHICH INCLUDES CLEANING
UP PEE AND POOP AND POSSIBLY
ASPIRATION PNEUMONIA BUT IT
BECAME A SERIES OF GOING TO THE
HOSPITAL WHEN AT HOME EMERGENCY
RESCUE MEDICINES DIDN'T WORK TO
STOP THE SEIZURES AND THEN, YOU
KNOW GETTING MORE MEDICINES IN
THE ER AND GETTING PUT INTO
MEDICALLY INDUCED COMAS AND
GOING BACK HOME AND LOOKING FOR
STABILITY, TRYING TO KEEP THIS
CHILD ALIVE.
IT WAS A CONSTANT CRISIS, IF YOU
THINK ABOUT A HIERARCHY OF NEED,
YOU KNOW MAZWELLs, WE'RE ADDED
THE BOTTOM, TRYING TO AVOID
CRISIS AND THIS WAS OUR LIVES
FOR 16 YEARS.
YOU KNOW SHE HAD MORE THAN 1
SEIZURE TYPES.
AT 1 POINT THE EEG PICKED UP 6
DIFFERENT SEIZURE TYPES,
INCLUDING 1S THAT WOULD THROW
HER TO THE GROUND, 1 THAT WOULD
CAUSE HER TO GO LIMP AND DROP TO
THE GROUND AND IT WASN'T UNTIL
AGE 5 THAT SHE WAS DIAGNOSED
LENNOX GASTRAUT DISORDER BACK
THEN WE KNEW IT BASED ON
CLINICAL FEATURES.
STARTING AT THE AGE OF 3 SHE
FELL BEHIND IN HER DEVELOPMENT
AND BY THE TIME SHE WAS 18 HE
HAD MORE THAN 40,000 SEEDURES,
SHE WAS ON 8 TREATMENTS FOR LGS
INCLUDING MEDICATIONS, DIET,
DEVICES, SURGERY, ALTERNATIVE
THERAPIES, ALL THE DEVICES YOU
WOULD THINK ABOUT WITH EPILEPSY,
VAGUS NERVE STIMULATION, DEEP
BRAIN STIMULATION IS MAKING A
ROUND IN OUR COMMUNITY, TRIALS
FOR MAGNETIC STIMULATION, YOU
NAME IT, WE'VE CONSIDERED IT OR
PARTICIPATED IN IT, ALONG WITH
THE COMMUNITY THEY WORK IN AS
THE EXECUTIVE DIRECTOR, WE HAVE
MORE THAN 8000 FAMILIES THAT
WE'RE WORKING WITH THAT ARE JUST
WALKING DEVICE STORIES, ALL OF
THEM.
SAVANNAH WAS DEVELOPMENTALLY
DELAYED AT THE AGE OF 18, SHE
WAS FUNCTIONING AT ABOUT A 3
YEAR-OLD LEVEL, DESPITE ALL
THESE INTERVENTIONSES ARE SHE
SLEPT AOUUT 18 ADAY AND
HER SEIZURES PERSISTED DESPITE
TREATMENT AND OUR FAMILIES, AT A
CERTAIN POINT, I THINK THE FIRST
THROUGH THERAPIES IN EPILEPSY
ARE THOUGHT OF RATIONALLY BUT
THEN AT A CERTAIN POINT IT
BECOMES A DART BOARD APPROACH
YOU PICK A MEDICATION OR TRIAL
AND YOU CYCLE THROUGH THOSE AND
BY AND LARGE THEY DON'T WORK,
MORE THAN 85% OF THE PATIENTS
CONTINUE TO HAVE SEIZURES INTO
ADULTHOOD IF THEY LIVE.
THERE IS A 24 X INCREASED RATE
OF DEATH IN OUR LGS POPULATION.
MORE THAN 95% ARE SEVERELY
INTELLECTUALLY DISABLED SO YOU
END UP IN THIS TREATMENT LOOP
JUST TRYING THIS.
SO NOT ONLY ARE YOU IN CONSTANT
SURVIVAL MODE BUT YOU'RE IN THIS
HEALTHCARE SYSTEM OF AN INSANE
TREATMENT LOOP WHICH IS VERY
DIFFICULT TO NAVIGATE.
BY THE TIME SHE WAS 18, SHE HAD
TRIED AND FAILED MORE THAN 26
DIFFERENT THERAPIES AS I
MENTIONED.
I THINK TO COMPLETE HER STORY
FOR YOU WHEN SHE WAS 18 WE DID
FIND THE GENETIC MUTATIONS THAT
WERE UNDERLYING THE SEIZURES
THAT EVOFFED INTO HER LGS AND WE
PUT HER ON MEDICATION, SHE HAS
CALCIUM CHANNEL OVERACTIVATION
DISORDER AND AS OF LAST YEAR
PRIOR TO GETTING COVID AT THE
AGE OF 28, SHE'S NOW 29, SHE WAS
DOWN TO 4 MEDICATIONS, HER
SEIZURES DROPPED BY 95%, HER
EPIDEPTIC EPISODES DROPPED AND
SO SHE DEVELOPED AND LEARNED
AGAIN AND THAT MEDICATION WAS
LIFE CHANGING AND SHE RECENTLY
GOT COVID AND NOW WE'RE
STRUGGLING AGAIN WITH SEEDSURES
BUT OVER ALL, YOU CAN SAY, THAT
THIS JOURNEY IS VERY TYPICAL OF
THE LGS JOURNEY AND SO WHEN WE
THINK ABOUT OUR FAMILIES
PARTICIPATE NOTHING A CLINICAL
TRIAL, WE HAVE TO THINK ABOUT IN
THE CONTEXT THAT THEY'RE ALREADY
INCREDIBLY OVERWHELM.
AND ANYTHING--YOU KNOW AND THIS
IS THE DESPERATE POPULATION THAT
IS LOOKING FOR ANSWERS, FROM THE
CLINICAL TRIAL.
SO WHEN I STARTED TO THINK ABOUT
WHAT IS THE MINIMUM THAT WE
NEED, YOU KNOW I THINK THAT WE
HAVE A GOOD BASE BOARD.
WE HEARD FROM PATIENTS AND
FAMILIES, WE HEARD FROM ALL THE
STAKEHOLDERS, YOU KNOW AND BUT I
THINK REFRAMING IT AND TO ANSWER
THE QUESTIONS, THE MIN NUM,
THESE ARE THE MIN NUM QUESTIONS
THAT WE HAVE TO ANSWER BEFORE
THE TRIAL AND THERE'S A SERIES
OF QUESTIONS, DURING THE TRIAL
AND THERE'S A SERIES OF
QUESTIONS AFTER THE TRIAL AND I
WON'T READ ALL OF THESE TO YOU
BUT I WILL SAY THESE QUESTIONS
ARE GOING TO BE ACROSS THE BOARD
FOR NO MATTER WHAT YOUR DISEASE
IS AND IF YOU WERE TO TAKE YOUR
SCIENCE AND MEDICAL BRAIN AND
THIS WILL BE THE QUESTIONS YOU
WANT ANSWERED AND I THINK THAT
CLINICAL TRIALS ARE
INTENTIONALLY SET UP TO BE
CONFUSING, YOU KNOW WE
DON'T--INFORMED CONSENT IS NOT
EASY, WE WORK WITH A LOT OF
SPONNORS THAT ARE LOOKING FOR
THERAPIES THANK GOD FOR LGS AND
THEY WILL OFTEN SAY GO TO
CLINICAL TRIALS .GOV TO LEARN
MORE ABOUT THE TRIAL.
I AM AN EDUCATED WOMAN WHO'S
BEEN AN ADVOCATE FOR 30 YEARS
AND I STILL STRUG WELCLINICAL
TRIALS.ON GOFF.
SO ANSWERING QUESTIONS ABOUT IS
THIS SAVE, WHAT IS THE BURDEN
FOR ME NOW IN TIME AND MONEY,
WHAT'S IT GOING TO BE IN THE
LONG-TERM.
LOOKING OUT, WHAT WILL THIS COST
ME IN TERMS OF TIME, QUALITY,
MONEY AND QUALITY OF LIFE, THAT
FINANCIAL COST COULD BE TIME, IT
COULD BE INVEST NMENT WHAT WILL
HAPPEN PSYCHOLOGICALLY AND OVER
TIME AS YOU'RE DEALING WITH
HAVING THIS DEVICE.
YOU KNOW 1 THING THAT HASN'T
COME UP ON OUR CONVERSATIONS
YET, YOU KNOW AS WE TALKED ABOUT
THIS, IS DATA SHARING, YOU KNOW
THIS--DATA THAT IS COLLECTED BY
ALL OF YOU GUYS, IN THE SPACE
IS, I KNOW YOU THINK OF IT AS
YOUR DATA, IT'S NOT YOUR DATA.
THIS IS DATA THAT HAS BEEN BUILT
ON THE BACKS AND BRAINING OF OUR
CHILDREN AND OUR LOVED 1S, RIGHT
IN LGS SPACE AND OTHER BODY
PARTS AND OTHER PATIENTS AND
OTHER GROUPS BUT THIS DATA HAS
TO BE SHARED SO WHEN I GO INTO A
TRIAL, I NOT ONLY KNOW I WILL
GET THE DATA AND AT SOME POINT
OTHER PEOPLE WILL GET THE DATA
BUT THAT IT'S MAXINALLY USED IN
A WAY.
YOU ARE COMING TO THIS, THERE'S
SO MUCH DATA THAT IS OUT THERE,
EVERY TIME I GO INTO A TRIAL, I
GET ASKED THE SAME QUESTIONS
OVER AND OVER AND OVER AGAIN AND
IT'S A BURDEN TO ME AND ALL THE
OTHER PEOPLE IN A TRIAL AND SO
ARE WE ACTIVELY MINING THE DATA
THAT'S COME BEFORE US TO DESIGN
THE TRIAL NOW AND ARE WE
ACTIVELY SHARING THE DAILY BASIS
THEA AFTER US SO THAT PATIENTS
DON'T HAVE TO KEEP ANSWERING THE
SAME QUESTIONS.
SO THESE ARE THE QUESTIONS
BEFORE, BUT THE MUST-HAVES IN MY
MIND ARE THE SAME NO MATTER IF
YOU ARE TALKING ABOUT BEFORE,
DURING
DURING OR AFTER THE TRIAL.
THAT'S THE MIND SET.
WE NEED TO BUILD EFFECTIVE
COMMUNICATION, IT'S NOT
EFFECTIVE.
IT'S NOT AND I SPENT 20 YEARS OF
MY LIFE, LIVING BELOW THE
POVERTY LINE AND BEING
UNEDUCATED AND I WORK A LOT IN
THE COMMUNITY IN THE PEOPLE WITH
PEOPLE OF DIFFERENT
SOCIOECONOMIC STATUS AND IT'S
EVEN WORSE FOR THEM FOR THEM AND
THE WAY I WAS BACK THEN AND
WE'RE ACTIVELY DISCRIMINATING IN
THOSE INSTANCES.
I THINK FAST AND EASY SERVICE IS
A LOT OF THESE TRIALS ARE ARE
VERY BURDENSOME, BECAUSE THAT'S
THE WAY WE'VE ALWAYS DONE IT,
RIGHT?
DO WE REALLY NEED TO DO IT THAT
WAY, IN THE BEFORE PHASE, I
THINK MINIMAL NONAPOPTOTIC NO
COST TO PATIENTS OTHER THAN
TIME, SPBLGLY DESIGNED AS I
EXPLAINED IN TERMS OF DATA USE
AND TRANSPARENT.
BUT THOSE ARE THE MUST-HAVEs
EVEN WHEN YOU'RE--THE SAME MUST
HAVES WHEN YOU ARE LOOKING AT
DURING THE TRIAL AND WE CAN
IMPLEMENT THINGS LIKE BRINGING
IN PATIENTS TO ASK THEM ABOUT
THE TRIAL PROTOCOL, I HAVE
ADVICE ON TRIAL PROTOCOLS, I DO
IT FOR FREE, MOW LONG LEADS CAN
YOU IMPLEMENT TELEHEALTH, CAN
YOU IMPLEMENT MOBILE FLEBOT ME,
THEY THINKS LIKE THAT.
SO I KNOW THIS IS FOCUSING ON
AFTER THE TRIAL, BUT HERE'S THE
QUESTIONS AFTER THE TRIAL.
DO I HAVE EASY ACCESS TO CARE
WHARKS ABOUT URGENT NEEDS,
SNRIET AND WE'VE SEEN SOLUTIONS
FOR THAT ALREADY, BUT I THINK WE
HAVEN'T FRAMED THE DISCUSSION SO
FAR AROUND THE PATIENT JOURNEY.
AM I GOING TO BE SAFE, IS THE
DEVICE WORKING, HOW DO WE DEFINE
WORKING.
HOW BURDENSOME IS THIS DEVICE ON
ME AND NOW IN THE FUTURE AND I
THINK A RESPONSIBLE TRIAL COMES
FROM US BEING ABLE TO ANSWER
EACH OF THESE QUESTIONS.
PART OF THE DISCUSSION GROUP WAS
TO OUTLINE WHERE RESEARCH
RELATED GROUP ISN'T PART OF IT
AND I THINK PATIENTS ARE WILLING
AND I THINK OTHER PEOPLE LIKE
INSURANCE CARRIERS AND MEDICAID
SERVICES AND THINGS LIKE THAT
ARE WILLING TO STEP UP.
WE CAN'T EXPECT THE SPONSOR TO
COVER EVERYTHING FOREVER FOR ALL
ETERNITY, THAT DOESN'T MAKE ANY
SENSE BUT THERE ARE INSTANCES
AND SO BUILDING THIS AROUND THE
EXISTING ECOSYSTEM IS GREAT AND
I LOVE DR. MORRELL'S TALK
YESTERDAY ABOUT HOW THEY'RE
NAVIGATING THIS WITH THE RNS
TRIAL.
WE'VE HEARD AND I WON'T GO OVER
THIS AGAIN AND IT WAS SUMMARIZED
BEAUTIFULLY THIS MORNING BUT WE
HEARD FROM PATIENT FAMILIES
YESTERDAY ABOUT THE THINGS THAT
THEY WISH THEY HAD AS RELATED TO
TRIAL AFTER CARE AND I DON'T
EVEN THINK I HAVE THEM ALL
LISTED HERE BUT THERE IS
CONSENSUS, SO, YOU'VE HEARD FROM
PATIENT FAMILIES, AND I WOULD
IMAGINE THAT THIS CONSENSUS HAS
BEEN SCHECTED ACTIVELY THROUGH
VARIOUS FDA PROGRAMS, THROUGH
VARIOUS RESEARCH PROGRAMS, YOU
KNOW VERY MUCH THE WAY THE
PATIENT FOCUSED DRUG DEVELOPMENT
WORK IS GOING ON WITHIN THE FDA,
I THINK THESE CONSENSUS
STATEMENTS ACROSS PATIENTS
DISEASE STATES EXIST.
I AGREE WITH EVERYTHING THAT WAS
SAID, AND I HAVE A PEDIATRIC
CASE, I HAVE AN ADULT WITH
SEVERE INTELLECTUAL DISABILITY,
THOSE WERE NOT THE PATIENT
ADVOCATES WE HEARD YESTERDAY BUT
I AGREE WITH EVERYTHING THEY
SAID.
I THINK PATIENT VALUE FRAMEWORKS
EXIST, RIGHT?
SO HERE'S 1 FROM WHERE THEY HAVE
BROKEN DOWN WHAT THE FAVORITE
VALUE IS, THEY REALLY HAVE
BROKEN OUT HOW YOU CAN RELATE
VALUE, WHAT IS IT THAT PATIENTS
VALUE AND THIS IS TAKEN INTO
ACCOUNT AS RELATING TO PATIENT
BLUING DEVELOPMENT WITHIN THE
FDA AND PATIENT DEVELOPMENT
DEVICE AS WELL AND YOU CAN BREAK
IT DOWN ACROSS PATIENTS, THERE
ARE THESE BUCKETS WE ALL FALL
INTO AND YOU CAN MEASURE THOSE
AND EACH OF THESE TOOLS ALL THE
WAY OVER TO THE RIGHT OF THE
SCREEN ARE WAYS CAN YOU ACTIVELY
MEASURE THESE THINGS THAT MATTER
TO PATIENTS.
WE KNOW HOW TO MEASURE QUALITY
OF LIFE IN LGS AND THAT COMES A
LOT FROM PATIENT ADVOCATES
PUSHING.
SO I THINK THAT ALL OF THE BITS
OF THE CONVERSATION ARE HERE,
EVERYTHING THAT I HEARD
YESTERDAY WAS SO INSPIRING, BUT
I THINK WHAT'S MISSING, STILL IS
AS WE MOVE FORWARD, AND AS THE
WORK GROUP MOVES FORWARD IS TO
REFRAME AROUND, YOU KNOW AROUND
THE PATIENT PERSPECTIVE, RIGHT?
SO WHAT DO PATIENTS VALUE, I
THINK WE HAVE A LOT OF
INFORMATION ON THAT. I THINK WE
NEED TO DEFINE WHAT BENEFIT
LOOKS LIKE AND I THINK A LOT OF
THIS PREWORK HAS BEEN DONE.
YOU SIMPLY NEED TO ASK, EACH
DISEASE STATE ORGANIZATION, YOU
KNOW HOW DO YOU VALUE?
I THINK A LOT OF THIS HAS BEEN
DONE WITH PFDD, WITH VALUE
FRAMEWORKS, WITH IN-HOUSE
SURVEYS WITH FOCUS GROUPS.
BUT I THINK THAT THE PATIENT
GROUPS AND PATIENTS THEMSELVES
HAVE EXPERIENCE WANT TO BE CO
CREATOR AND CO DESIGNERS IN THIS
PROCESS AT EVERY STAGE OF THE
LEVEL, YOU KNOW THE WEATHER, IN
THE BASIC RESEARCH OR DESIGN OR
EXIT OF THE TRIAL.
PATIENTS WILL ADVISE AND HELP
YOU TO SAVE TIME AND MONEY AND
SUFFERING, I PROMISE YOU.
AND THEN I THINK IF WE MAP THIS
OUT ACROSS THE PATIENT JOURNEY,
I THINK THAT'S USEFUL.
A CLEAR DEFINITION OF WHEN THE
TRIAL IS OVER I THINK IS
IMPORTANT AND A TRANSITION PLAN,
IT SOUNDS LIKE I WAS REMINDED A
LOT AS WE WERE GOING THROUGH
THIS, OF WHAT HAPPENS WHEN WE GO
FROM PEDIATRIC NEUROLOGICAL
CARE, TO ADULT NEUROLOGICAL CARE
AND WE'RE GIIVE A PIECE OF PAPER
AND THROWN OUT INTO THE ADULT
NEUROLOGY WORLD WHICH IS VERY
DIFFERENT AND FEELS LIKE THAT'S
KIND OF HAPPENING.
PATES ARE KIND OF PUSHED OUT
INTO THE TRIAL WORLD AND THERE'S
NOT THIS CLEAR TRANSITION PLAN
AND WHAT DOES THAT LOOK LIKE AND
HOW ARE YOU EQUIPPED TO MANAGE
THIS FOR THE NEXT 30 YEARS.
CLEAR INFORMED CONSENT, IT
SERVES US AS DOCTORS, IT SERVES,
YOU KNOW US THAT ARE IN THE
RESEARCH BASE, BUT IT'S DOES NOT
SERVE FAMILIES AT ALL.
AN EMPHASIS I WOULD SAY ON OTHER
POPULATIONS, AGAIN, PEDIATRIC,
SEVERE INTELLECTUAL DISABILITY,
LOW SES, AND 1 MORE EMPSCIZZ ON
JUST THE MAXIMAL LEARNING,
THERE'S SO MUCH DATA OUT THERE.
EVERYONE HAS DAT AT ON OUR LGS
FAMILIES EXCEPT US.
AND WHAT I HAVE TO GO THROUGH TO
GET MY OWN DAUGHTER'S DATA IS A
PAIN, I CAN'T GET DATA FROM THE
TRIALS HE'S BEEN IN, I'M FINE
WITH EMBARGOED DATA FOR A
CERTAIN TIME BUT I WANT THAT
DATA AND I WANT IT SHARED IN OUR
COMMUNITY.
THE NUMBER 1 QUESTION WE GET IN
THE LGS IN THE COMMUNITY IS HAVE
YOU EVER SEEN THIS WEIRD RASH?
AND HAVE YOU SEEN THIS BEHAVIOR?
THAT DATA EXISTS IN THE TRIALS
FROM THE PAST AND IT DOESN'T GET
SHARED.
AND THEN OFTEN WE PUBLISH A
PAPER ON THE TRIAL OUTCOME AND
THEN IT GETS TRANSLATED DOWN TO
PATIENTS SO THAT'S A LOT OF WHAT
WE DO IN THE GROUPS SO I THINK
I'M INSPIRED BY EVERYTHING
THAT'S BEEN SAID BUT I WOULD
LOVE TO SEE SORT OF A REFRAME
AROUND THE PATIENT JOURNEY WHICH
DID COME UP YESTERDAY AND
HOPEFULLY THIS TALK MAYBE SET
THE STAGE FOR SOME GREAT
DISCUSSION AROUND THAT.
THANK YOU.
>> THANK YOU SO MUCH TRACEY,
THAT WAS WONDERFUL.
DOES ANYONE HAVE A QUESTION FOR
DR. DIXON-SALAZAR BEFORE WE MOVE
TO THE NEXT SPEAKER.
I WOULD LOVE TO HEAR QUESTIONS
FROM ANYBODY IN THE AUDIENCE OR
ANYBODY ON THE PANEL.
>> THIS IS RHONDA.
I HAVE A QUESTION.
THANK YOU SO MUCH FOR YOUR
PRESENTATION AND THE INFORMATION
YOU GIVING IS VERY, VERY
MEANINGFUL AND VERY HELPFUL.
I'M JUST WONDERING PARTICULARLY
WITH THE COMPLEXITY OF THE
DISORDER THAT YOUR DAUGHTER AS
HAD AND - I IMAGINE THERE AREN'T
MANY PHYSICIANS WHO UNDERSTAND
OR KNOW ANYTHING ABOUT IT, IS
THE TRANSITION FROM POST
CLINICAL TRIAL TO THE REGULAR
PROVIDER SYSTEM ALSO A PROBLEM
IN TERMS OF THOSE PROVIDERS
BEING AWARE OF THE RESEARCH
, THE
OUTCOMES OF THE RESEARCH IN
TERMS OF BEING A HELPFUL CO
HEARING OF THIS.
>> YEAH, THE ANSWER IS IT IS A
PROBLEM ACROSS THE BOARD IN ALL
DISEASE STATES, I KNOW THAT
BECAUSE I SPENT A LOT OF TIME
WITH OTHER DISEASES BUT
ESPECIALLY WITH LGS
SPECIFICALLY, YOU KNOW IT
DEPENDS ON THE TRIAL RIGHT.
SO VAGUS NERVE STIMULATOR WAS
ALREADY APPROVED WHEN WE WENT
INTO THE TRIAL FOR AN EXTEBDED
STUDY AND SO INITIALLY WHEN IT
FIRST CAME ON THE MARKET, YOU
MET A LOT OF PATIENTS AND
FAMILIES WHERE IT WAS FIRST
APPROVED WHO WERE STRUGGLING
BECAUSE NOBODY KNEW ABOUT IT AND
NOBODY HAD THE TRIAL DATA AND
YOU COULD ONLY GO TO THESE
SPECIALIZED CENTERS, RIGHT?
BUT THEN IF YOU GO TO AN
EXTENDED TRIAL, THAT'S GOING TO
EXPAND THE DAILY BASIS THEA BASE
AND THE DATA KNOWLEDGE, NOW AT
LEAST THERE'S A CHUNK OF PEOPLE
THAT AT LEAST HEARD OF IT SO YOU
LESSENED IT BUT THE HANDOFF IS
STILL INCREDIBLE LOAMACYY
PAINFUL.
THERE'S A FEW SPECIALISTS THAT
EXIST IN LGS, THERE'S LIKE 20 IN
THE U.S. THAT I COULD NAME OFF
THE TOP OF MY HEAD AND EVEN THAT
KNOWLEDGE OF JUST THE SYNDROME
ITSELF, NOT THE VERY SPECIALIZE
TREATMENTSA ISSUES ROUND IT IS
JUST CONCENTRATED IN THAT BODY
AND YET MOST LGS PATIENTS ARE
TREATED BY GENERAL NEUROLOGY OR
EVEN GENERAL PRACTICE.
SO IT'S A REAL PROBLEM WITH THE
HANDOFF AND IT'S EVEN WORSE IF
YOU HAVE A TRIAL WHERE YOU WANT
TO CONTINUE THE STUDY SO
MAGNETIC STIMULATION WAS IN THE
LGS PATIENTS AND WE ACTUALLY HAD
A NUMBER OF RESPONDERS THAT
RESPONDED TO THIS AND WE WERE
PART OF THIS AS WELL AND AGAIN
NOT AN IMPLANTABLE DEVICE BUT
IT'S LIKE NOBODY KNOWS HOW TO
DID IT, THE TRIAL WILL NOT
CONTINUE, IT WAS AN ACADEMIC
STUDY, RIGHT?
AND THERE'S REALLY NOTHING TO
MOVE FORWARD WITH IT AND SO THE
PATIENTS MOBILIZE TO TRY TO GET
THE STUDY TO CONTINUE ON AND
FOUND IT BUT IT'S REALLY LIKE
NOW, ON TOP OF EVERYTHING ELSE
THAT WE'RE DEALING WITH, YOU ARE
HAVING TO TRY TO NOW FIGURE OUT
A WAY TO GET THIS FOR YOUR CHILD
BECAUSE YOU SAW A HUNDRED%
REDUCTION IN SEIZURE WHEN IS
YOU'RE KID WAS ON IT AND NOW
IT'S COMPLETELY OVER.
SO THERE IS NO TRANSITION PLAN.
IT'S SORT OF LIKE WE GET HANDED
THE GOODS AND TOLD TO MOVE ON
AND I THINK WHAT WAS GREAT
YESTERDAY WHEN WE SAW HOW PANE
PEOPLE RECALLED THE INFORMED
CONSENT DISCUSSION, IT HAPPENED,
SOMEBODY SAID WELL WE TALKED
ABOUT THIS, OKAY, WELL, ON THE
BACK DROP OF MY KID LIKE
STRIPPING NAKED IN THE DOCTOR'S
OFFICE AND THE BEHAVIOR SHE HAS
AT SCHOOL AND THE CLINICAL TRIAL
WE'RE IN AND ALL THE MEDICATIONS
I HAVE TO GIVE HER A DAY, I
DIDN'T REMEMBER THAT.
I'M SORRY.
AND SO I THINK THAT'S A LONG
ANSWER TO YES, IT'S A PROBLEM.
A TRANSITION PLAN WOULD BE
REALLY HELPFUL FOR EACH OF THE
SCENARIOS OF DEVICES OUT THERE,
EXTENSION STUDY, DEVICE IS
BRANDT SPANKING NEW AND IT
DIDN'T GET APPROVED.
>> I THINK WE HAVE TIME FOR 1
MORE QUESTION AND TRACEY I WILL
LET YOU KNOW THERE ARE A NUMBER
OF QUESTIONS IN THE Q&A WHEN
YOU'RE FINISHED, YOU CAN LOOK AT
THEM BUT MAYBE WE CAN ASK RONALD
TRIOLLO?
ASK HIS QUESTION.
>> SORRY, I RAISED MY HAND BY
MISTAKE.
SORRY ABOUT THAT.
MAYBE THEN WE WILL MOVE ON TO
THE NEXT SPEAKER.
>> I HAD A COMMENT.
>> SORRY?
>> I HAD A COMMENT.
GO AHEAD.
>> JOHN MARLER AT FDA, I JUST
NOTED TO SAY I THINK THIS GROUP
SHOULD REALLY LISTEN TO THE
MESSAGE DELIVERED HERE THAT THE
CLINICAL TRIALS HAVE BECOME VERY
INEFFICIENT.
THEY'RE COMPLICATED, I THINK
UNNECESSARILY SO AND I WHOLE
HEARTEDLY ENDORSE, 1 OF THE
MAJOR PROBLEMS WITH GETTING,
INTERPRETING THE RESULTS OF
CLINICAL TRIALS IS LARGE DROP
OUT RATES, LACK OF COMPLETION OF
THE STUDY BY PATIENTS, WE GET
DISCOURAGED AND LEAVE THE TRIAL,
SO I REALLY THINK TRACEY EAD
COMMENTS ARE EXTREMELY VALUABLE
AND WE SHOULD KEEP THOSE IN THE
FOREFRONT.
I BELIEVE THAT THE WAY TO MOVE
FORWARD IS TO REALLY START
BRINGING IN PATIENTS FROM THE
BEGINNING, THE DESIGN OF THIS
STUDY AND ALL OF THE DETAILS OF
IT BECAUSE IF THEY DON'T SUPPORT
IT, IF THEY DON'T BELIEVE IN THE
IMPORTANCE OF RANDOMIZATION WHEN
IT REQUIRED AND SO ON, IT JUST
DOESN'T HAPPEN EFFECTIVELY.
SO THAT'S MY COMMENT, THANK YOU.
>> THANK YOU IF ARE THAT
COMMENT.
I THINK I JUST WANT TO REMIND
EVERYBODY THAT PANELISTS, YOU
CAN ANSWER QUESTIONS IN THE Q&A.
IF YOU WILL WANT TO BUT WE'RE
ALSO FOR EVERYBODY WHOSE
QUESTIONS DID NOT GET ANSWERED
AT THIS MOMENT, I WANT TO REMIND
YOU WE WILL HAVE A LARGER
DISCUSSION AT THE END OF ALL THE
PANELISTS PRESENTATION,MENT SO
THEN IT'S MY PLEASURE TO
INTRODUCE THE NEXT PANELIST,
DR. P A TRICIO, RIFFA POSSE, WHO
IS ASSISTANT PROFESSOR IN THE
DEPARTMENT OF PSYCHIATRY AND
BEHAVIORAL SCIENCES AT EMORY
UNIVERSITY WHERE HIS CLINICAL
AND RESEARCH ACTIVITIES FOCUS ON
TREATMENT MOOD DISORDERS, THE
RATIONAL ISHT VENTION PSYCHIATRY
SERVICES AND DEPRESSION
COMPONENT, ALSO VICTORY IN
INVASIVE AND NONINVASIVE
NEURO[INDISCERNIBLE] TECHNIQUES
AND INCLUDING THE VAGUS NERVE
STIMULATION, ELECTIVE COMPULSIVE
THERAPY AND ELECTROMAGNETIC
TRANSLATION, AND THANK YOU FOR
SO MUCH FOR PARTICIPATING AND WE
LOOK FORWARD TO YOUR TALK.
>> THANK YOU DR. HENDRIKs, I
HOPE EVERYONE CAN SEE MY
PRESENTATION.
SO I WANT TO FIRST DO A
DISCLOSURE, I HAVE RECEIVED
CONSULTING FEES FROM JANSSEN
FARM SUITALS FOR DRUGS THAT ARE
RELATED TO THE TREATMENT OF
DEPRESSION AND SUICIDALLITY BUT
NOT RELATED TO WHAT PUTS US
TOGETHER IN DEEP BRAIN
STIMULATION OR THE
INTERVENTIONAL INVASIVE
NEUROMODDULATION.
THE DEVICES THAT WE HAVE WORKED
WITH FOR THESE YEARS AT EMORY
AND MT. SINAI OUR PARTNER HAVE
BEEN DONATED ALWAYS BY JAINT
JUDE MEDICAL INITIALLY AND IN
MORE RECENT YEARS BY MEDTRONNIC.
AND WE WORK UNDER AN
INVESTIGATIONAL DEVICE EXEMPTION
AND WE HAVE 2 OPEN TRIALS IN
CLINICAL TRIALS .GOV, SOME OF
THEM THAT ARE ACTIVE BUT NOT
RECRUITING PATIENTS AND THAT
INITIALLY OUR FUNDS WERE
ESSENTIALLY FOUNDATION GRANTS
FOR MANY, MANY YEARS UNTIL
RECENTLY, THE LAST 4 OR 5 YEARS,
WE WERE AWARDED UH3 GRANT WITH
DR. HELEN MAYBERG AND COMBINING
OUR WORK BETWEEN THE MT. SINAI,
EMORY UNIVERSITY AND GEORGIA
TECH.
SO, YOU KNOW--I KNOW THAT TODAY
IS SORT OF WHAT SHOULD BE THE
MIN NUM THAT ANY RESEARCH
RELATED CARE SOME HAVE.
AND I THINK THAT AS A SIMPLE
QUESTION, IT CANNOT BE ANSWERED
IN A STRAIGHT FORWARD WAY.
MOST INVESTIGATOR INITIATED
QUESTIONS AND IDEAS.RY SMALL
THESE EVOLVE OVER TIME WITH
INCREASING COMPLEXITY, SOMETIMES
IN, YOU KNOW GEOGRAPHIC
LOCATIONS, BUT ALSO IN TERMS OF
THE PARTNERSHIPS THAT WE
DEVELOP, THE FUNDING SOURCES AND
THE AVAILABILITY OF RESEARCHERS
TO PROVIDE COMPREHENSIVE CARE.
I WILL USE THE EXAMPLE OF DEEP
BRAIN STIMULATION FOR DEPRESSION
WITH SPECIFIC LOCATION IN THE
SUBCOLOSSAL AREA WHICH IS WHERE
OUR WORK HAS BEEN FOCUSED FOR
THE PAST 15 YEARS.
THE INITIAL STUDY WAS START
INDEED CANADA.
AND IN CANADA DR. MAYBERG WHO
CAN'T BE HERE TODAY BUT
DR. MAYBERG AND DR. LOZANO WHO
IS A NEUROSURGEON DIDN'T HAVE
THE NEED IT TO FILE FOR DEVICE
EXEMPTION.
THEY USED COMMERCIALLY AVAILABLE
DEEP BRAIN STIMULATION DEVICES
AND WITH THE HYPOTHESIS, THEY
CONDUCTED THE SURMRYS, THE
CONCOSTS OF SURGERIES WERE
ASSUMED BY THE HOSPITAL,
ABSORBED BY THE SYSTEM, THEY DID
EVERYTHING UNDER RESEARCH
PROTOCOL WITH PATIENTS BEING
CONSENTED BUT ESSENTIALLY ISSUES
THE COMPLEXITY OF DOING A SMALL
CLINICAL TRIAL TO DEMONSTRATE,
YOU KNOW A SMALL DEGREE OF
EFFICACY WAS NOT THAT
CONVOLUNTEERSUDED, RIGHT?
AND I KNOW THAT MAYBE IT WAS THE
NAIVEETY OF THE BEGINNING.
THE IMPLEMENTATION OF SUBJECTS
ACTUALLY GENERATED A LOT OF
NOISE IN THE NEUROSCIENTIFIC,
PSYCHIATRIC COMMUNITY, IN THE
NEUROSURGICAL COMMUNITY AND IT
WAS PUBLISHED IN NEURON IN 2005
SO MANY, MANY YEARS AGO AND THIS
OPENED UP THE POSSIBILITY OF
SAYING, WELL, DEEP BRAIN
STIMULATION MAY BE EFFECTIVE IN
THE TREATMENT OF PSYCHIATRIC
DISORDERS.
FOLLOWING DR. MAYBERG'S PATH,
SHE MOVES TO EMORY UNIVERSITY
WHERE SHE SPENT THE NEXT 12-13
YEARS.
AND HERE IS WHERE WE MEET.
AND THE INITIAL IMPLEMENTATION
OF THESE DEVICES, YOU KNOW ALSO
STARTED WITH AN INITIAL, YOU
KNOW COMMITMENT BY THE
HEALTHCARE SYSTEM IN WHICH, YOU
KNOW THE INVESTIGATIONAL DEVICE
EXEMPTION WAS FILED TO THE FDA
AND THE HOSPITAL SIZE, YOU KNOW
HERE AT EMORY AGREED TO SUPPORT
THE INITIAL SURGERIES, USUALLY,
YOU KNOW MOST HEALTHCARE SYSTEMS
THAT ARE INTERESTED IN
DEVELOPING INVASIVE
NEUROMODDULATION CENTERS, THEY
ENTICE THE PARTICIPANTS OR THE
FACULTY THAT THEY WANT TO BRING
INTO SAYING WELL, WE WILL FUND A
NUMBER OF SURGERIES FOR YOU AND
THIS IS ALWAYS OPENLY DISCUSSED
BECAUSE OF COURSE, GETTING FUNDS
FOR SURGERIES THAT CAN BE
UPWARDS OF A HUNDRED THOUSAND
DOLLARS IF 1 DOESN'T EVEN
CONSIDER, YOU KNOW VERY DETAILED
EXPERIMENTAL PROCESSES, CAN
DRAIN ONCE THE INITIAL START UP
FUNDS QUITE RAPIDLY.
AND THE SURGERIES WERE FUNDED BY
EMORY HEALTHCARE, BY FOUNDATIONS
RELATED TO EMORY AND BY
FOUNDATIONS THAT ARE WELL
CONNECTED AND VERY GENEROUS IN
THEIR SUPPORT OF THE--OF NEW
PSYCHIATRIC TREATMENTS, LIKE THE
HOPE FOUNDATION, THE DANNA
FOUNDATION.
AND WHEN WE STARTED HERE, YOU
KNOW AND I JOIN INDEED 2008, AT
THE BEGINNING THERE WAS AN'T A
QUESTION OF WHAT TO DO WHEN
THERE IS NO INSURANCE COVERAGE,
BUT YOU KNOW WHAT WE REALIZED IS
THAT WHILE THE INITIAL COSTS
WOULD HAVE BEEN ABSORBED BY THE
HEALTHCARE SYSTEM, CONTINUOUS
CARE OF PATIENTS THAT HAVE AN
IMPLANTABLE DEVICE IS NOT FREE
OF CHARGE.
FOR THE SYSTEM, FOR THE
INVESTIGATORS, JUST TO GIVE YOU
AN EXAMPLE, WHILE WE WERE USING
BATTERIES THAT WERE ORIGINALLY
DESIGNED FOR PARKINSON'S DISEASE
THAT HAS MUCH LOWER CURRENT
USAGE, AND USUALLY PATIENTS ARE
ALSO IMPLANTED LATER IN LIFE.
WHAT BRANDY ELLIS WHO IS 1 OF
OUR PARTICIPANTS HERE SAID, YOU
KNOW WHEN YOU'RE IMPLANTED IN
YOUR 30S AND THE AVERAGE LIFE IN
OUR TARGET, AT OUR SETTINGS IS
ABOUT NOT EVEN A YEAR AND A
HALF, YOU KNOW, WE FOUND THAT
THE--THE MANAGEMENT OF BATTERY
REPLACEMENTS WAS AN ONGOING
ISSUE, YOU KNOW, OUR
NEUROSURGEON WHO WASN'T BILLING
FOR THESE PROCEDURES WAS OPENING
UP O. R. DATES, I WAS GOING TO
THE OPERATING ROOM USUALLY ABOUT
ONCE A MONTH, YOU KNOW WE HAD A
LARGE NUMBER OF PATIENTS THAT
WERE COMING, YOU KNOW MORE
THAN--YOU KNOW EVERY YEAR AND A
HALF TO GET A BATTERY
REPLACEMENT AND THE ADDITIONAL
ASPECT THAT THIS WAS NOT EVEN,
LIKE IT'S THOUGHT OF AT THE
BEGINNING IS THE MORE BATTERY
CHANGES THAT 1 MAKES, THE HIGHER
THE LIKELIHOOD OF COMPLICATIONS
FROM THE LOCAL SURGERY WHETHER
IT'S MILD INFECTIONS, WHETHER
IT'S A LEAD BREAK, YOU KNOW THE
MANIPULATIONS OF THESE SYSTEMS
IS NOT MADE FOR FREQUENT, OPEN
AND CLOSE.
SO SPORTINATELY CHANGED WHEN WE
WE WERE GIVEN ACCESS TO A
RECHARGEABLE BATTERY BUT FOR
YEARS, I HAD NO IDEA WHEN THESE
BATTERIES WOULD BE AVAILABLE,
THE RECHARGEABLE BADRYS.
EVERY BATTERY OF A BATTERY WAS,
YOU KNOW WHEN DO WE GET THE
RECHARGEABLE, WELL, PROBABLY THE
NEXT 1 AND SO ON AND SO FORTH
BECAUSE WE HAD PATIENTS WITH 6
BATTERY REPLACEMENTS UNTIL THEY
GOT THE RECHARGEABLE BATTERIES
THAT WEREN'T AVAILABLE IN 2015
OR 16, BUT YOU KNOW WHAT
HAPPENED, WELL, I WILL TELL YOU
IN A FEW MINUTES, MEDICARE THEN
AGREED TO COVER THE SURGERIES IN
AN INDIVIDUAL SITE AGREEMENT
WITH US, WE WERE ABLE TO GET OUR
PATIENTS COVERED AND YOU KNOW
WHAT'S VERY IMPORTANT FOR US AND
ADVOCATES FOR OUR PATIENTS TO
GET COVERED, BUT ONCE THEY'RE
COVERED BY MEDICARE, WE CAN GO
TO THIS TO PRIVATE INSURANCES
AND SAY, HED CARE HAS AGREED TO
COVER, IF ANY PATIENT HAS A
MEDICARE ADVANTAGE PLAN, THEY
WERE COVERED AS WELL BUT IF THEY
HAD INSURANCE WERE NOT ON
DISABILITY, WE COULD USE THE
EVIDENCE OF MEDICARE SUPPORTING
OUR WORK TOWARDS GETTING
APPROVAL AND YOU KNOW THIS IS
VERY LONG PROCESS THAT FOR
ANYONE ESPECIALLY AS I ASSUME
PATIENTS WHO HAVE NAVIGATED THE
COMPLEXITIES OF OUR HEALTHCARE
SYSTEM, SOMETIMES IT'S ASKING
FOR A PEER TO PEER REVIEW,
SOMETIMES IT'S ASKING FOR YOU
KNOW WHETHER YOU GO THROUGH THE
MEDICAL PART AND YOU TALK WITH A
NEUROSURGEON, A PSYCHIATRIST AND
I AM A PSYCHIATRIST, A
PSYCHIATRIST WILL NEVER APPROVE
THIS BECAUSE THEY WILL--THEY
WILL BASE IT BASICALLY SAY THIS
IS AN EXPERIMENTAL TREATMENT
THAT SHOULD NEVER BE COVERED.
AND YOU KNOW, THE PRIVATE
INSURANCES ARE TENUOUS, NEVER
STRAIGHT FORWARD, SOME PATIENTS
HAD BAT RESILIENCE PLACEMENTS
APPROVED BEFORE AND THEN DENIED
AND THEN COVERED AGAIN.
APPEALS, APPEALS, VERY FEW CASES
WE'VE BEEN FORTUNATE PATIENTS
HAVE HAD TO FACE THE COST OF THE
ENTIRE PROCEDURE FOR EXAMPLE,
YOU KNOW, WE DON'T--WE HAVE
AGREED NOT TO NECESSARILY BILL
FOR OUR PATIENT'S WHEN IT'S DBS
RELATED CARE BUT ON THE OTHER
HAND, YOU KNOW THE DEVICE
COMPANIES AND AT 1 POINT THEY
WERE SENDING US BATTERIES EVERY
MONTH CAN AND THOSE BATTERIES
WERE NOT COMMERCIALLY AVAILABLE
SO THEY HAVE TO PROVIDE THAT
ESPECIALLY ALSO WITH EXTENSION
CASES.
SO IN PARALLEL AND I DON'T WANT
TO, YOU KNOW DELAY TOO MUCH BUT
WE WERE NOT PART OF THE INDUSTRY
SPONSORED CLINICAL TRIAL FOR DBS
AND DEPRESSION BUT IT WAS A
MULTICENTERRED DOUBLE PLIEND
TRIAL THAT YOU KNOW WAS HALTED
PREMATURELY DUE TO A FUTILITY
ANALYSIS THAT PREDICTED THIS
WOULD NOT WORK AND AS YOU SEE
HERE, IN THE CONTROL, AND IN THE
STIMULATION ARMS THIS DIDN'T
WORK SO WHEN YOU LOOK AT THE
OVERALL DATA, MODULATION AND
THESE EUROPEAN STUDIES AND THEY
MANAGED TO SEE, YOU KNOW BETWEEN
144 AND 172 PATIENTS AND YOU SEE
HOW THE BENEFITS ARE PERCEIVED
WAY BEYOND THE USUAL DURATION OF
A CLINICAL TRIAL.
THAT'S WHY, YOU KNOW WHEN I
THINK ABOUT THE MINIMUM
NECESSARY, YOU KNOW INFORMATION
AND SUPPORT THAT WE NEED FOR THE
CLINICAL TRIAL, WE NEED THESE
DATA COLLECTION ENTERPRISES TO
LAST BEYOND THE SIXTH OR 12
MONTHS.
BECAUSE OTHERWISE WE WILL NOT
SEE THE ABSOLUTE BENEFITS THAT
WE ARE OBSERVING IN DEEP BRAIN
STIMULATION AND THAT'S ALSO KIND
OF ULTIMATELY WHAT I WANT FROM
AN IMPLANTABLE HIGH RISK
POTENTIALLY COMPLICATED AND
ESPECIALLY EXTREMELY EXPENSIVE
TECHNOLOGY BUT IT DOESN'T WORK
IN THE LONG RUN IT'S NOT WOOTHER
IT BUT THERE'S NO CLINICAL TRIAL
FORMAT THAT WILL ALLOW FOR YEARS
AND YEARS OF FOLLOW UP.
THIS WAS REPLICATED BY US HERE
THIS WAS PUBLISHED A COUPLE
YEARS AGO AND THE OTHER THING WE
NOTICE IS THAT PATIENTS DO NEED
A BATTERY REPLACEMENT.
IF WE STOP STIMULATION, PATIENTS
BECOME DEPRESSED AGAIN SO THIS
REQUIRES AN ONGOING FOLLOW UP
BUT EVERYBODY THOUGHT THAT THE
TRIAL WAS NOT EFFECTIVE.
IT WAS THE FIRST TIME THAT
CLINICAL DEEP BRAIN STIMULATION
HAD PSYCHIATRY FUNDING AND I MAY
BE MISTAKEN BUT I'M PRETTY SURE
THIS WAS THE FIRST TIME WE WERE
ABLE TO MOVE FORWARD WITH NIH,
WITH FEDERAL FUNDING IN MEETINGS
WITH INDUSTRY AND THE
INVESTIGATORS TO MOVE THIS
FORWARD, OKAY?
LARGE TEAMS.
AND IN OUR EXPERIENCE, YOU KNOW
THE BATTERIES CHANGE, WE TART
WIDE 1 BADRY AND THEN THAT
BATTERY IS DISCONTINUED AND THEN
WE SWITCH TO A RECHARGEABLE
BATTERY BUT NOW THAT
RECHARGEABLE BATTERY DIDN'T
RECORD HAD WHICH IS THE PRIMARY
OBJECTIVE OF OUR TRIAL SO
WETHODE IMPLANT PATIENTS AGAIN
WITH RECORDING DEVICES THAT WILL
NOT BE AVAILABLE AND THE PROBLEM
WITH THESE BATTERIES IS THAT
ONCE THEY'RE NOT COMMERCIALLY
APPROVED PATIENTS WILL HAVE
DIFFICULTY GETTING MRIs FOR
THE REST OF THEIR LIFE SINCE
THEY HAVE A NONFDA APPROVED
DEVICE, THERE'S NEVER AN MRI
COMPATIBILITY SIDE.
AND NOW, I THINK JUST TO WRAP
UP, THE IMPORTANT THING IS THAT,
YOU KNOW THERE'S A DIFFERENCE
BETWEEN THE NEEDS THAT A SMALL
FIRST IN HUMAN STUDY WOULD HAVE
15 YEARS AGO TO THE WAY I WOULD
DESIGN A CLINICAL TRIAL TODAY IN
MEETING WITH THE INDUSTRY,
RIGHT?
BUT WE DON'T HAVE ANY OFFICIAL
SUPPORT TO MAINTAIN A RESEARCH
COORDINATOR TO MAINTAIN TIME
FROM A PSYCHIATRIST TO DEDICATE
TO THE ALL THE PATIENTS THAT ARE
IMPLANTED, WE ARE SEEING
PATIENTS THAT HAVE BEEN
IMPLANTED IN OTHER NIH STUDIES
THAT YOU KNOW WERE LOST TO
FOLLOW UP OVER THERE OR THE
BROADENED CLINICAL TRIAL IN DEEP
BRAIN STIMULATION THAT THEIR
SITES CLOSED OR THEIR
INVESTIGATORS MOVE AND THEY HAVE
NOWHERE TO GO.
SO THEY GO INTO
CLINICALTRIALS.GOV AND THEY COME
TO THE PLACE THAT KEEPS ON DOING
IT.
WE FORTUNATELY HAVE, YOU KNOW
THE POSSIBILITY OF DOING THIS
THROUGH THE TIME WE ARE DOING
OTHER NEUROMODDULATION AND
TRIALS, BUT HARDWARE CHANGES AND
EVOLVES BUT IT'S GREAT TO HAVE
RECHARGEABLE BATTERIES BUT WHAT
HAPPENS WHEN THEY'RE NOT
AVAILABLE ANYMORE, WHEN THE
RECHARGEABLE BATTERIES ARE NOT
AVAILABLE ANYMORE, THEN THE
RECHARGEABLE SYSTEM IS NOT
AVAILABLE ANYMORE AND IN THE
DEVICE FAILS, THEY HAVE TO WAIT
A MONTH KNOWING THE DEPRESSION
WILL RETURN, THAT'S THE XASM
BRANDY USED YESTERDAY OF SHARING
RECHARGING SYSTEM BUT WE HAVE
MORE THAN 30 PATIENTS, OVER 10
DLNCHT STATES AND SOMETIMES
PATIENT WEES DIDN'T EERVE CHOOSE
TO IMPLANT BUT THEY CAME FOR OUR
CARE AFTER THE INITIAL CLINICAL
SITE CLOSE.
OKAY?
SO WHAT HAPPENS TO THE PATIENTS
THAT ARE LOST TO FOLLOW UP.
WHAT HAPPENS WITH THE PATIENTS
THAT ARE NOT INCLUDED IN THE
INITIAL CLINICAL TRIAL DATA.
THOSE TRIAL IS LOST AND WE DO
NEED THIS PARTNERSHIP BETWEEN
NEUROSURGERY AND PSYCHIATRY TO
CONTINUE TO PROVIDE SUPPORT AND
YOU KNOW AND HOW TO WORK IN THIS
FOR YOU KNOW 15 YEARS NOW.
I'M A TESTIMONY OF HOW THESE
TREATMENTS HELP OUR PATIENTS,
HOW THIS IS NEEDED AND SOMETIMES
I WORRY THAT YOU KNOW CLINICAL
TRIALS FROM THE NIH ARE FOCUSED
TOO MUCH ON GETTING THE SPECIFIC
SCIENTIFIC QUESTION AND ANSWER,
FROM INDUSTRY, IS SEEING WHAT
MARKET THEY WOULD HAVE.
--CLINICAL TRIALS AND SMALL
NUMBERS THROUGH NIH SPONSORED
TRIALS THAT ARE INCREDIBLE
LOAMACYY GROUND BREAKING, BUT WE
DON'T ADDRESS THE TOTAL NEED FOR
YOU KNOW PATIENTS AND THEY'RE
STILL DYING OF SUICIDE BEING
DISABLED, ET CETERA.
SO, YOU KNOW I THINK THAT FOR
THINKING ABOUT THE FUTURE, WE DO
NEED, YOU KNOW TO MOVE ABOUT THE
SCALABILITY OF THIS AND NOT, YOU
KNOW SOMETIMES SMALL CLINICAL
TRIALS THAT WILL IMPLANT, YOU
KNOW MAYBE 5 PATIENTS A YEAR
WHICH IS ALL WE CAN HANDLE WITH
A TEAM THAT HAS, YOU KNOW
SOMETIMES 30 PEOPLE DEPENDENT ON
THAT.
AND THOSE ARE THE QUESTIONS THAT
COME, YOU KNOW TO MY MIND WHEN I
THINK ABOUT THE FUTURE IN
RESEARCH IN DEPRESSION WITH DEEP
BRAIN STIMULATION.
OKAY?
SO I DON'T WANT TO TAKE MORE
TIME.
BUT I WOULD REALLY LIKE ALSO
COMPATIBILITY FOR THESE DEVICES
AND THAT'S THE LAST THING I WILL
SAY, ALL RIGHT.
SO MAYBE YOU CAN ANSWER SOME
QUESTIONS BEFORE DR. HSU, AND
DR. HENDRIKs, MOVE ON TO THE
NEXT PANELIST.
THANK YOU SO MUCH FOR INVITING
ME.
>> THANK YOU, I THINK WE HAVE
TIME FOR 1 QUESTION, WHO HAS A
QUESTION?
>> SARA BURN?
>> THANK YOU SO MUCH FOR YOUR
TALK, I WAS STRUCK BY WHAT
BRANDY SAID YESTERDAY AND WHAT
YOU SAID ABOUT THE TIMELINE, SO
SHE SAID SHE WAS GETTING
INCREMENTAL BENEFITS BUT SLOWLY
RIGHT AND IF THE TYPICAL
TIMELINE FOR CLINICAL TRIAL FOR
ASSESSMENT TO SEE WHETHER OR NOT
THERE'S FUTILITY OR IT'S
WORKING, IS MUCH SHORTER, I
GUESS I'M JUST TRYING TO--I'M
STRUGGLING TO FIGURE OUT HOW YOU
HANDLE THAT BECAUSE THAT SEEMS
LIKE A--A STRUCTURAL KIND OF
QUESTION, THAT ISN'T REALLY
ABOUT POST TRIAL, IT'S JUST--HOW
DO WE RECREATE TRIALS OR YOU
KNOW REVISION WHAT THEY WOULD
BE?
>> YEAH, AND I THINK, YOU KNOW
FROM A CLINICAL APPLICABILITY,
RIGHT?
MY BIG QUESTION AS A CLINICIAN,
AS A TRYST, AS A DOCTOR WHO SEES
PATIENTS IN THE DAY-TO-DAY BASIS
WHETHER IT'S IN THE ECT CLINIC
OR IN THE OUTPATIENT CLINIC, IF
I'M GOING TO PROPOSE THIS VERY
INVASIVE TREATMENT TO SOMEONE,
IT BETTER WORK FOR A LONG TIME
AND THERE IS REALLY VERY FEW,
YOU KNOW--THERE ARE VERY FEW
OPPORTUNITIES TO SAY, HOW LONG
SHOULD YOU COLLECT DATA.
WE PUBLISHED ON 8 YEARS.
THE VAGUS NERVE STIMULATION DATA
THAT PROMPTED THE NEW CED TRIAL
WAS BASED ON 5 YEARS OF
MONITORING PATIENTS, YOU KNOW
IMPROVEMENT.
THIS EXCEEDS, THE, YOU KNOW,
MOST OF THE PEOPLE THAT CREATED
THE INITIAL CLINICAL TRIALS, YOU
KNOW KIND OF HAD THE IDEA FROM
DRUG TRIALS, RIGHT?
TWELVE WEEKS ON THIS VERSUS
PLACEBO, DID YOU RESPOND, YES OR
NO?
THIS IS COMPLETELY DIFFERENT.
ALL OF OUR PATIENTS HAVE FAILED
15, 20 MEDICATIONS, 95% OF MY
PATIENTS HAVE DONE MANY COURSES
OF ECT, SO THE APPLICABILITY OF
SAYING WHETHER THIS WORKS IN 6
MONTHS, IT'S REALLY NOT
REALISTIC, RIGHT?
AND YOU KNOW FROM MY--AS BRANDY
SAID YESTERDAY, BRANDY TO ME WAS
A WINNER FROM DAY 1.
BUT IT TAKES A LOT OF TIME TO
YOU KNOW, TO REALIZE THE
FUNCTIONALITY IMPROVEMENTS TO
REALIZE THAT INDEPENDENCE
PATIENTS ACHIEVE TO KNOW THEY
ARE STANDING ON GROUND THAT IS
FIRM AND THEY WILL NOT BE
DEPRESSED AGAIN.
OKAY?
>> I KNOW WE'RE RUNNING LONG,
CAN I ASK A QUICK FOLLOW UP, SO
WOULD YOUR--WOULD 1 SOLUTION BE
TO TRY TO EXTEND THE TIME THAT'S
OFFERS FOR OBSERVING AND
FIGURING OUT IF THE CLINICAL
TRIAL IS WORKING OR IS IT ENOUGH
JUST TO SAY, ANY TIME THIS KIND
OF IMPLANT IS HAPPENING, LET'S
ADD THE 5 YEAR LONG-TERM FOLLOW
UP.
I DON'T KNOW WHAT WE CALL THAT
STUDY, RIGHT?
BUT I THINK ALSO JENNIFER FRENCH
TALKED ABOUT YESTERDAY, JUST AS
A MATTER OF COURSE WHICH WOULD
ALLOW FOR THAT KIND OF
OBSERVATION.
>> WELL WE KEEP ON--WE SEE THESE
PATIENTS, YOU KNOW REGULARLY,
NOW EVERY 6 MONTHS TO 1 YEAR,
SOME PATIENTS HAVE BEEN
IMPLANTED IN 2007.
SO, YOU BE AND THEY LIVE OUT OF
STATE.
YOU KNOW, NOW WITH COVID, I'VE
BEEN DOING ZOOMS WITH ALL OF
THESE PATIENTS THAT WE'VE GROWN
TO KNOW EACH OTHER, YOU KNOW
OVER TIME THEY'VE SEEN ME LOSE
HAIR, GAIN WEIGHT AND SO ON AND
O FORTH AND YOU KNOW WE STILL
HAVE A GREAT RELATIONSHIP, I
HOPE, BUT YES, I THINK THAT'S
THE MOST IMPORTANT THING.
RATHER THAN SEEING WHETHER
PATIENTS GET BETTER IN A MONTH
OR IN 2 MONTHS, THAT'S POINTLESS
IN A WAY FOR SOMETHING THAT
NEEDS TO STAY WELL FOR 10 YEARS,
RIGHT?
OR THAT THE RESPONSE IS LIMITED.
IF MAISHTS WERE TO GET DEPRESSED
AGAIN AT 1 YEAR AND NEVER GET
BETTER AGAIN, YOU KNOW?
YEAH.
>> ALL RIGHT.
I THINK WE HAVE LOTS ALREADY TO
DISCUSS AND WE'RE GOING TO HAVE
A GREAT HOPEFULLY GREAT
DISCUSSION BUT WE STILL HAVE A
FEW MORE PEOPLE TO HEAR FROM.
SO I WOULD LIKE TO INTRODUCE OUR
NEXT SPEAKERS, SARA GOERING, WHO
IS A PHILOSOPHER PROGRAM ETHICS
AT THE UNIVERSITY EVER
WASHINGTON AND CORE FACULTYOT
PROGRAM OF ETHICS AND THE
DISABILITIES STUDIES PROGRAM AT
THE UNIVERSITY OF WASHINGTON AND
SHE ALSO CO LEADS THE ETHICS
THRUST AT THE UNIVERSITY OF
WASHINGTON CENTER FOR
NEUROTECHNOLOGY.
AND SAN --SARA WILL BE PRESENTIG
WITH ISHAN DASGUPTA, WHO IS WITH
THE DANA FARBER FOWBDATION, SHE
IS LAWYER BY TRAINING AND
EVALUATIONS METHODOLOGY AND
QUANTITATIONS AND
PRACTICALLY--OOPS I MISSED
MY--AND POLICY ANALYSIS, SORRY,
SORRY!
OKAY, TAKE IT AWAY, SARA.
>> HI, EVERYONE, I WILL START
OFF SO I WOULD LIKE TO THANK THE
NIH FOR THIS INVITATION TO THE
QUESTION OF WHAT IS OWED TO
NEURAL INPLANTED STUDIES.
SO CAN MOVE TO THE NEXT SLIDE.
SO, YOU KNOW WHEN I WAS THINKING
ABOUT THIS FIRST QUESTION FOR
THE SESSION ABOUT WHAT IS THE
MINIMUM THAT'S OWED, I WAS
THINKING ABOUT THE FACT THAT
THEY WERE MENTIONING YESTERDAY
THAT THERE WERE NO MANDATED
RULES AND REGGULESS AROUND THE
POST TRIAL WORKSHOP, SO I LOOKED
AT 1 OF OUR WORKSHOPS FROM LAST
AND WHEN I WAS REVIEWING THE
BIOETHICS, THERE WAS AREA OF
BROAD CONSENSUS, THE CAVEAT IS
THAT MOST OF THIS LITERATURE
COMES RELATED TO THE TOPIC OF
CLINICAL TRIALS FOR
ANTIRETROVIRALS IN THE EARLY
2000S SO IT MIGHT NEED TO BE
ADJUSTED FOR THE DEVICE SETTING.
SO FIRST THEY SHOULD HAVE THE
DIGS PENS GOING BACK TO
YESTERDAY, WE'VE BEEN HEARING
THIS OVER AND OVER AGAIN, BUT IT
SEEMS PARTICULARLY IMPORTANT IN
NEURAL IMPLANT SETTING NOT JUST
ANTICIPATE THE LIKELY NEED BUT
COME UP WITH A SOLID PLAN AND
GIVEN THE DURATION OF THESE
STUDIESS, PEOPLE MIGHT LIVE WITH
THESE DEVICES FOR 20, 30 YEARS
SO IT'S IMPORTANT TO COME UP
WITH SOMETHING CONCRETE HERE.
SECOND PARTICIPANTS SHOULD BE
INFORMED ABOUT WHAT THOSE PLANS
ARE AND THEY SHOULD BE INFORMED
IN A WAY THEY CAN UNDERSTAND AND
APPRECIATE.
WE HAVE TO OVERCOME LEGAL-EASE
AND OVERLY SORT OF, YOU KNOW
COMPLICATED INFORMED CONSENT
DOCUMENTS, AND GOING BACK TO
GATES STUDY YESTERDAY, IN MY
EXPERIENCE TALKING WITH END
USERS, I FOUND SIMILAR STORIES
ABOUT PEOPLE NOT FULLY
UNDERSTANDING WHAT EXACTLY THEY
WERE SIGNING UP FOR OR SIMPLY
NOT REMEMBERING CONVERSATIONS
ABOUT WHAT HAPPENS AFTER A STUDY
ENDS.
ONE OPTION HERE IS ON THE
ABILITY TO CONNECT RESEARCH
PARTICIPANTS TO OTHER PEOPLE WHO
HAVE BEEN PARTS OF STUDIES SO
THEY CAN GET A BETTER IDEA OF
WHAT PARTICIPATION ACTUALLY
INVOLVES.
THE THIRD AREA IS THAT
PARTICIPATION SHOULD RECEIVE
CONTINUED ACCESS IF IT'S BENEFIT
TO THEM.
OF COURSE, CALCULATING BENEFIT
IS GOING TO BE A TRICKY THING
AND IT DEPENDS ON FACTORS SUCH
AS WHETHER A STUDY IS
THERAPEUTIC OR WHETHER, YOU KNOW
IT'S TRYING TO HAVE--TRYING TO
TEST MORE OF A PROOF OF CONCEPT,
AND SO, IT REALLY WILL DEPEND ON
THE PARTICULAR SETTING OF THE
TRIAL TO FIGURE OUT WHAT
ACTUALLY COUNTS AS BENEFIT.
THE BROAD CONSENSUS.
AROUND THE FACT THAT
OBLIGATIONS, DIDN'T JUST MEAN
ACCESS TO TREATMENTS AND IT
COULD INCLUDE THINGS LIKE
TRANSITION OF CARE AND THE
IMPLANT SETTING, IT MIGHT ALSO
INCLUDE SUPPORT FOR STWRANSITION
OUT OF THE STUDY ESPECIALLY FOR
NONTHERAPEUTIC IS ITS.
NEXT SLIDE, PLEASE.
WHEN IT COMES TO THE QUESTION OF
WHAT'S OFFERED BEYOND THE
MINIMUM, I THINK THERE WAS LESS
CONSENSUS IN THE TRADITIONAL
BIOETHICS LITERATURE.
BUT IN PRACTICE WHAT IS OFTEN
OWED OR WHAT--YOU KNOW WHAT GOES
BEYOND FOR THAT MINIMUM WAS
ACTUALLY WHAT'S IN THE INFORMED
CONSENT DOCUMENT, SO YOU KNOW IT
REALLY BOILS DOWN TO WHAT THAT
SPECIFIC STUDY TEAM OR
INVESTIGATOR ACTUALLY PROMISED
BUT YOU KNOW EVEN THEN WE CAN
SEE THAT THERE'S OFTEN PROBLEMS
WITH THAT, RIGHT?
YESTERDAY WE MENTIONED THIS
COMPANY, SEVERAL PEOPLE
MENTIONED THIS COMPANY'S SECOND
SITE BUT FOR OUR WORKSHOP WE
USED A CASE EXAMPLE FOR A
SIMILAR COMPANY CALLED NEURAL
CONTROL WITH THE FUNCTIONAL AND
EFFECTIVE, EFFICACY AND LEADING
PARTICIPANTS THAT ARE BENEFITING
AND WITHOUT OPTIONS SO EVEN WHEN
PROMISES ARE MADE IN THE
INFORMED CONSENT DOCUMENTS IT
CAN BE AN UPHILL BALGT FOR THEM
TO GET THAT POST TRIAL ACCESS.
AND SO, IN FIGURING OUT, YOU
KNOW WHAT WOULD BE CONSIDERED
AND ADDITIONAL
RERESPONSIBILITIES, 1 MODEL WE
COULD LOOK TO IS RICHARDS' ON
THE PARTICIPANTS AN CELLARY AND
AND HELP TO THOSE RESEARCHERS
WHEN THEY AGREE TO JOIN THE
STUDY.
RICHARDSON DEFINES ANCILLARY
CARE OF STUFF THAT'S NOT
SCIENTIFICALLY VALID TO INSURE
TRIAL SAFETY OR RESEARCH
INDUSTRIES AND THOUGH HE WAS
PRIMARILY WRITE NOTHING
REFERENCE TO ANTIRETROVIRAL
STUDIES, YOU KNOW BASED ON OUR
CONVERSATION FROM YESTERDAY AND
TODAY, IT'S CLEAR THAT
PARTICIPANTS OF THE NEURAL
IMPLANT STUDIES MIGHT REQUIRE
WHAT ARE CALLED ANCILLARY CARE
AND IN FACT, THE MORAL
ENTANGLEMENTS THAT RICHARDSON
DESCRIBES IN THIS WORK MAY BE
MORE RELEVANT IN THIS SPACE
BECAUSE PARTICIPATION IS
BURDENSOME AND PARTICIPANTS
BUILD LASTING RELATIONSHIPS WITH
RESEARCHERS.
>> NEXT SLIDE, PLEASE, SO WHILE
WE DON'T HAVE AN ANSWER TO THIS
QUESTION OF WHETHER THEY'RE
GOING TO HAVE THE MINIMUM, THERE
ARE FACTORS THAT MIGHT BE
RELEVANT IN TERMS OF FIGURING
OUT WHEN THAT HAPPENS.
SO FIRST FACTOR IS WHEN
PARTICIPANTS TAKE ON A
SIGNIFICANT RISK TO PARTICIPATE
IN STUDIES, THEY MAY BE OWED
MORE THAN THE MINIMUM, AND NOT
ONLY DOES PARTICIPATION IN THESE
STUDIES REQUIRE INVASIVE BRAIN
OR SPINAL SURGERY, THE
LITERATURE, THE NEURAL ETHICS
LITERATURE REPLETE WITH
ASSOCIATED RISK TO ADJUSTING
WITH THE LIVING DEVICE AND FOR
ALL THESE RISKS AND AS WE
MENTIONED, YOU KNOW THE
CONSIDERABLE BURDENS INVOLVED IN
PARTICIPATION, IT'S ACTUALLY
KIND OF SURPRISING TO FIND OUT
THAT PARTIC PLAN TO ANALYZE BY
AGES ARE RELATIVELY
UNCOMPENSATED, ESPECIALLY WHEN
CONSIDERING THE BCI TRIALS, YOU
KNOW OFTEN REQUIRE A LOT OF
EFFORT, YOU KNOW GOING IN
MULTIPLE TIMES A WEEK FOR THE
COURSE OF 4 OR 5 OR LONGER
PERIODS OF TIME, AND WITH THE
POSSIBILITY IT MIGHT NOT
CLINICALLY BENEFIT THE
PARTICIPANT.
FINALLY IF PARTICIPANTS ARE
DEPENDENT ON RESEARCHERS FOR
MORE ACCESS THERE MAY BE MORE OF
AN OBLIGATION, AS WE HEARD
YESTERDAY, IT'S OFTEN NEXT TO
IMPOSSIBLE TO RECEIVE THE SAME
CARE FROM A DIFFERENT DOCTOR LET
ALONE A DIFFERENT INSTITUTION
AND THAT DEGREE OF DEPENDENCY OR
LACK OF OTHER ALTERNATIVES MAY
ALSO SPEAK TO WHEN MORE IS
REQUIRED.
NEXT SLIDE, PLEASE.
SO WE WILL BRIEFLY SHARE DATA
FROM 2 PROJECTS WE WORKED ON AT
THE UNIVERSITY OF WASHINGTON.
BOTH ARE FUNDED BY THE NIH THE
FIRST HAS A MENTIONED EARLIER
WAS AN EXPERT WORKSHOP THAT WE
HOSTED USING VIRTUALLY LAST MAY,
AND THE SECOND IS RO1 LOOKING AT
ISSUES OF AGENCY, BUT WE ALSO
ASKED A LOT OF QUESTIONS ABOUT
POST TRIAL ISSUES THROUGHOUT OUR
INTERVIEWS.
NEXT SLIDE, PLEASE.
SO I WANTED TO TELL BUT THIS
WORKSHOP, SO OUR AIM WAS
NONAPOPTOTIC THE TO REACH
CONSENSUS BUT RATHER TO SORT OF
EXPLORE AREAS WHERE WELL PLIGHT
BE BROAD AGREEMENT ABOUT ETHICAL
JUSTIFICATION AND SO, THE
PRIMARY ATTENDEES FOR THIS
WORKSHOP WHERE NIH FUNDED
NEUROETHICISTS ALTHOUGH WE DID
INCLUDE SEVERAL CLINICIANS AND
REPRESENTATIVES FROM THE NIH IN
FACT MANY PEOPLE WHO ARE IN THIS
MEETING ODAY WERE IN
WORKSHOP AS WELL.
SO JUST A QUICK NOTE ABOUT
FORMAT, WE SHARED BACKGROUND
RESEARCH AND WE GAVE A QUICK
OVERVIEW AT THE BEGINNING OF THE
DAY LONG MEETING AND THEN WE HAD
A FULL DAY OF DISCUSSIONS
NSLIDE.
SO 4 QUESTIONS, IS THERE A
ABNORMALITIES LIFE ON
EARTHIGATION AT ALL, SECOND, IF
THERE IS AN OBLIGATION, IS THE
NEURAL IMPLANT CONTEXT UNIQUE,
DOES IT REQUIRE DIFFERENT
JUSTIFICATIONS, AND GETTING THE
LITTLE BIT OF TODAY'S SESSION
QUESTION, THE THIRD QUESTION WE
ASKED IF WELL IS AN OBLIGATION
TO PROVIDE, HOW FAR DOES THAT
EXTEND AND FINALLY, WE ALSO
ASKED OR AT LEAST INTENDED TO
ASK WHEN STAKEHOLDERS ARE
RESPONSIBILITY.
WE DIDN'T GET TO QUESTION 4
BECAUSE WE REALIZED IT'S VERY
DIFFICULT TO APPROACH THAT
QUESTION WITHOUT HAVING
STAKEHOLDERS IN THE ROOM.
SO NEXT SLIDE.
SO I WANT TO ACTUALLY SHARE A
FEW TAKE AWAYS FROM THAT MEETING
THAT ARE REEL KEEPSAKES STROONT
THIS QUESTION ABOUT WHAT MINIMUM
IS OWED.
AND I WANTED TO HIGHLIGHT THAT
THIS SPEAKS TO SORT OF THE BEAR
MINIMUM REQUIRED AND IT MIGHT
CHANGE DEPENDING ON THE SPECIFIC
CONTEXT OF THE IS IT THE AND
MIGHT BE SITUATIONS WHERE MORE
THAN THE MIN NUM IS OWED BUT
WORKSHOP ATTENDEES BROADLY
AGREED THAT IMPLANTABLE DEVICES
ARE UNIQUE AND THE ETHICAL JUST
IVENGZS FOR POST TRIAL CARE WILL
BE DIFFERENT FROM OTHER CONTACT
AND ESPECIALENTIALLY A LOT OF
THE LITERATURE WRITTEN AROUND
ANTIRETROVIRALS, AT THE VERY
LEAST, THERE WAS BROAD SUPPORT
THAT AT A BEAR MINIMUM, THERE IS
AN OBLIGATION TO PROVIDE
CONTINUED ACCESS IF THOSE ARE
TREATMENTS ARE PROVEN TO BE
BENEFICIAL.
NOW WE HAD A LOT OF DISCUSSION
ABOUT WHAT BENEFIT MEANS AND
GIVEN THE HETEROGENERATED AITY
OF THESE IN THIS SPACE, I WILL
MENTION THIS IS A COMPLICATED
CONCEPT BUT THAT BEING SAID, THE
FINAL TAKE AWAY I WILL SHARE IS
THAT BENEFIT HAD TO BE
UNDERSTOOD MORE BROADLY THAN
IT'S CURRENTLY BEING FRAMED.
IT CAN'T JUST BE ABOUT CLINICAL
BENEFIT AND AGAIN IT WILL
DEPENDOT CONTEXT BUT THAT BEN
PIT HAS TO BE UNDERSTOOD IN THE
WHOLISTIC SENSE.
AND THERE COULD BE FOR EXAMPLE,
PARTICIPATE NOTHING THE STUDY
ITSELF, HAVING THE ABILITY TO
PARTICIPATE AS A POTENTIAL
BENEFIT.
I'M GOING TO PASS IT ON TO MY CO
PRESENTER, SARA.
>> GREAT, SO NEXT SLIDE, PLEASE.
NOW I WANT TO TELL BUT
INTERVIEWS THAT ISHAN DID THAT
WE DID AS PART OF OUR RON 1 WITH
END USERS OF DEVICES AND I WANT
TO SAY HERE WE HAVE A LOT OF
PEOPLE WHO ARE USING BCIs FOR
MOTOR, CONTROL SO THEY'RE
CONTROLLING A CURSOR OR A
ROBOTIC ARM THAT MEANS THEY
DON'T CARRY THE DEVICE, THEY
CARRY IT WITH THEM BUT THEY
DON'T TAKE IT OUTSIDE THE LAB,
THEY ARE ONLY ABLE TO USE THE
DEVICE WHEN THEY'RE IN THE LAB
BUT WE ALSO INTERVIEWED PEOPLE
WHO HAVE AN EXPERIMENTAL CLOSED
LOOP DEVICE, A DBS DEVICE AND
IT'S TREATING A CONDITION
THERAPEUTICALLY AS THEY'RE
WALKING AROUND DAY-TO-DAY SO
THAT MEANS WE HAVE DIFFERENT
KINDS OF CONDITIONS IN HERE,
DIFFERENT KINDS OF STUDIES
REPRESENTED.
NEXT SLIDE, PLEASE.
SO SOME AREAS OF AGREEMENT FROM
PARTICIPANTS WE TALKED WITH,
COMPENSATION TR TIME AND EFFORT,
RECOGNITION OF PARTICIPATION OF
THEIR SIGNIFICANT CONTRIBUTION
TO WHAT'S HAPPENING AS TRACEY
SAID IN THE TALK EARLIER IN THE
PANEL, YOU DON'T GET THAT DATA
EXCEPT BY OFF THESE PARTICIPANTS
THEY HAVE TO BE THERE FOR THE
STUDY TO BE POSSIBLE, SO IT'S A
RECOGNITION OF THAT
CONTRIBUTION.
MEDICAL CARE RELATED TO THE
IMPLANT FOR THE REST OF THE
PARPANTS LIFE, THIS IS SOMETHING
WE HEARD REGULARLY, GIVEN IT'S
AN IMPLANTABLE DEVICE AND IT'S
TYPICALLY STAYING WITH THEM AND
IF THEY'RE BENEFITING CONTINUED
ACCESS AND UPKEEP AND
MAINTENANCE AS WE TALKED ABOUT
ALREADY.
NEXT SLIDE.
APOPTOTICKINGS, OTHER WAY.
I JUST WANT TO SHOW YOU A COUPLE
OTHER THINGS PEOPLE SAID ON THE
COMPENSATION POINT.
ONE GUY IS COMPARING HIMSELF TO
SOMEBODY ELSE IN THE STUDY, HE
SAID HE ONLY GOT GAS MONEY, THEY
DIDN'T GIVE HIM ANYTHING FOR HIS
TIME REALLY, THAT'S NOT ENTIRELY
FAIR.
I THINK THEY OWE FAIR
COMPENSATION AND TO LOOK AT WHAT
THEY'RE ASKING OF PEOPLE.
AGAIN THIS IS COMING FROM A BCI
STUDY, PEOPLE ARE THERE IT'S
LIKE A PART-TIME JOB, 3 TIMES A
WEEK, 3 HOURS A SESSION, MAYBE
OVER 5 YEARS, AND THAT THEY ALSO
NEED TO GET THERE, RIGHT?
OFTEN HAVE A CAREGIVER OR
SOMEONE ELSE WHO WILL FACILITATE
TRANSPORTATION AND HELP WHILE
THEY'RE AT THE STUDY SITE.
ANOTHER TELLING QUOTE, SOMETHING
NEEDS TO BE GIVEN BACK TO THE
PARTICIPANTS BUT IT CAN'T BE
ENOUGH TO BE A MOTIVATING FACTOR
FOR THEM TO GO THROUGH.
SO THIS IS A RECOGNITION OF THE
PUSH AND PULL, YOU DON'T WANT
REALLY HIGH COMPENSATION BECAUSE
YOU DON'T WANT TO HAVE UNDUE
INDUCEMENT TO ENTER THE TRIAL
FOR SOMEBODY'S WHO'S
IMPOVERISHED AND WOULD OTHERWISE
QUALIFY AND DO IT FOR THAT MONEY
BUT, THEY KEEP THE COMPENSATION
REALLY LOW.
IT'S ALMOST LAUGHABLE, I FEEL A
PARTICIPANT SHOULD BE
COMPENSATED, I FEEL IT SHOULD BE
MEASURED BASED ON THE LEVEL OF
RESEARCH OR THE RESEARCH THEY'RE
PARTICIPATING IN SO HOW MUCH
TIME AND EFFORT IS REQUIRED
THERE.
NEXT SLIDE.
PEOPLE TALKED ABOUT THE
RECOGNITION, RIGHT?
THEY'RE BUILDING THEIR CAREERS
OFF OF US, OFF OF TEST SUBJECTS
AND THESE ARE MULTIMILLION
DOLLAR CAREERS, WE SHOULD BE
THANKED AND RECOGNIZED IF ARE
OUR PARTICIPATION RIGHT?
IT'S THIS SORT OF ACKNOWLEDGMENT
OF THE LEVEL OF CONTRIBUTION AND
THE INTEGRAL NATURE OF THAT
CONTRIBUTION ON CONTINUED
MEDICAL CARE FOR AS LONG AS HAVE
YOU THE DEVICE IF YOU.
I THINK YOUR WHOLE LIFE BECAUSE
IT FEELS SO WEIRD IF YOU DIDN'T
HAVE ANYONE TO TALK TO IF
SOMETHING HAPPENS.
THIS GETS AT THE ISSUES THAT ARE
BROUGHT UP ABOUT EXPERTISE.
YOU HAVE TO HAVE SOMEBODY WHO
KNOWS MEN AND WOMEN TO DO.
SOMEBODY IN OUR STUDY SAID, IF
HAVE YOU AN ACCIDENT, AND YOU GO
TO THE E. R., YOU HAVE TO CALL
SOMEBODY ABOUT THE DEVICE BEFORE
OTHER THINGS CAN HAPPEN BECAUSE
YOU WANT TO PROTECT THAT DEVICE.
AND THEN FINALLY, THIS IS
SOMEBODY WHO'S TREATED WITH A
DEVICE, CARRIED WITH HIM THAT'S
THERAPEUTIC, I WOULD RATHER BE
DEAD THAN NOT TO HAVE THIS.
WHEN WE WERE TALKING ABOUT THE
POSSIBILITY OF NOT HAVING
ACCESS, HE'S ECHOING SOMETHING
THAT WE HEARD YESTERDAY FROM
OTHER PARTICIPANTS.
ALL RIGHT, NEXT SLIDE.
SO WHEN WE WOULD HAVE
RESPONSIBILITIES TO PROVIDE OR
FACILITATE MORE?
SOME OF THE THINGS PEOPLE TALKED
ABOUT THAT SEEM RELEVANT TO
PROVIDING EVEN MORE THAN THE MIN
NUM IS JUST THE HIGH BURDEN OF
TIME AND ENERGY, THE VERY CLOSE
RELATIONSHIPS THEY BUILD, THE
STUDY TEAMS OVER 5 YEARS OR
BEYOND AND THE MINIMAL POTENTIAL
CLINICAL BENEFIT ESPECIALLY FOR
THE PEOPLE IN THE BCI LAB.
NEXT SLIDE AND THIS IS MY LAST 1
AND THEN WE WILL CLOSE.
SO RELATIONSHIPS WITH
RESEARCHERS, IF I LEFT THIS
STUDY AND WE DIDN'T HAVE SOME
TYPE OF SOCIAL CONNECTION
AFTERWARD, YEAH, I WOULD BE
DISAPPOINTED BECAUSE I THINK
THAT OVER THIS TIME WE'VE BECOME
MORE LIKE FAMILY.
THIS JUST SPEAKS TO HOW
ENTANGLED PEOPLE ARE AFTER THAT
LONG PERIOD AND THEN I WANT TO
ADD HERE IS FOR PEOPLE IN BCI
STUDIES IT MIGHT NOT HAVE A
CLINICAL UTILITY PER SE BECAUSE
THEY'RE NOT CARRYING IT WITH
THEM, BUT THAT PARTICIPATION
ITSELF CAN BE LIFE ALTERING, IT
CAN GIVE PEOPLE A SENSE OF
MATTERING, YOU KNOW THE THINGS
THAT PEOPLE SAY ABOUT HOW IT
TURNED THEIR LIFE AROUND, BEING
ABLE TO BE PART OF THAT AND I
WILL TURN IT OVER FOR THE WRAP
UP.
>> SO SUMMING UP, TAKE WAIRKSES
FROM BOTH OUR QUALITATIVE
INTERVIEWS AS WELL AS THE EXPERT
WORKSHOP BEING HELD, THERE ARE A
FEW THINGS WE KNOW.
PARITS PANTS AND ETHICS,
ETHICISTS ALIKE RECOGNIZE THAT
IMPLANTING DEVICE INTO SOMEONE'S
BRAIN RAISES OBLIGATIONS BEYOND
TYPICAL CLINICAL TRIALS.
AND THAT PARTICIPATION IS
RECOGNITION FOR EFFORT, PERHAP
THIS IS TAKES THE FORM OF
COMPENSATION FOR THEIR WORK, AND
MAYBE IT TAKES A FORM OF ACCESS
TO THE DEVICE IF IT'S WORKING
AND BENEFICIAL, BEYOND THE STUDY
PERIOD.
BUT IT ALSO PERHAPS INCLUDE
THINGS LIKE ACCESS SUPPORT AND
CARE AFTER THE TRIAL AND A LAST
TAKE HOME IS THAT YOU KNOW BRAIN
BIONEARS IN PARTICIPANTS IN THIS
SPACE ARE RISKING--TAKING RISKS
AND INVESTING EFFORT TO HELP
MOVE THE SCIENCE AND TECHNOLOGY
FORWARD.
AND YOU KNOW THEIR EFFORT
DESERVES PROPER RECOGNITION
COMPENSATION.
MY LAST SLIDE.
BUT THERE ARE A FEW PIECES WE
NEED TO FIGURE OUT AND TO PUSH
THIS CONVERSATION FORWARD FROM
ETHICAL PRINCIPLES TO ACTUAL
POLICY AND CAME OUT OF OUR
WORKSHOP AS WELL AND QUICKLY,
THE 4 THINGS THAT YOU KNOW THAT
WE STILL NEED MORE DATA ON IS
REALLY SORT OF FIGURING OUT HOW
MUCH DO THESE--HOW MUCH WILL
THIS ACCESS AND POST TRIAL CARE
ACTUALLY COST?
YOU KNOW WE DEFINITELY NEED MORE
DATA FROM ACTUAL RESEARCH
PARTICIPANTS, FAMILIES, CARE
TAKERS ABOUT, YOU KNOW WHAT THEY
WANT AFTER A TRIAL AND WHAT THEY
WISHED THEY HAD KNOWN BEFORE
THEY SIGNED UP FOR A CLINICAL
TRIAL LIKE THIS.
AS WELL AS DATA FOR THIS POST
TRIAL ERA AND AS WELL AS
INFORMATION ABOUT WHAT IS
REQUIRED IN TERMS OF AN
INFRASTRUCTURE OF PROVIDING
CARE, EVEN IF WE HAVE FUNDING
FOR IT.
THANK YOU SO MUCH FOR INVITING
US AND WE WOULD BE HAPPY TO TAKE
QUESTIONS.
>> WONDERFUL.
THANK YOU VERY MUCH ISHAN AND
SARA.
ANYONE HAVE A QUESTION FOR THEM?
OR WE CAN JUST ADMIRE THAT GREAT
GROUP OF PEOPLE THERE.
>> ALSO GO, TOO.
>> I HAVE A QUESTION, I REALLY
APPRECIATED BOTH THE SUMMARY OF
WHAT YOU CAME UP WITH THE
WORKSHOP YOU HAD BUT ALSO THE
DATA HAVE YOU THAT KIND OF
SUPPORTS WHAT YOU CAME UP WITH
FROM THE WORKSHOP, SO, 1 TAKE
WAIRKS IS THAT THIS IS A UNIQUE
SPACE, RIGHT?
THAT THERE'S SOMETHING DIFFERENT
ABOUT THIS HAN ANOTHER CLINICAL
TRIALS AND I THINK I HEARD ISHAN
SAY, THAT THE MORAL
ENTANGLEMENTS ARE MORE DEEP OR
COMP LITICATED OR SOMETHING LIKE
THAT.
I GUESS, IS THE THEN CONCLUSION
THAT WE OWE MORE TO PEOPLE
BECAUSE OF THAT?
>> I WOULD SAY SO.
AND I THINK THIS IS BORNE OUT BY
SOME OF THE DATA THAT WE
RECEIVED AND YOU KNOW SARA
POINTED TO SOME OF THESE QUOTES.
WHEN I TALK TO PARTICIPANTS THEY
REALIZE THAT THEY ARE DOING
SOMETHING UNIQUE, AND THEIR
CONTRIBUTION IS VERY SPECIAL.
I MEAN JUST JUSTICE, I WAS
THINKING ABOUT, YOU KNOW LOOKING
AT SOMETHING ON TWITTER ABOUT
HOW THE NUMBER OF PEOPLE
IMPLANTABLE BCI TRIAL SYSTEM
SOMETHING LIKE 30 OR 40 IN THE
ENTIRE WORLD, SO I THINK, YOU
KNOW THIS SORT OF--THIS UNIQUE,
DATA THAT PARTICIPANTS ARE
PROVIDING DOE SORT OF
NECESSITATE FURTHER OBLIGATIONS,
AND IT'S NOT JUST THE DATA THAT
THEY'RE PROVIDING BUT IT'S THE
DAY-TO-DAY RELATIONSHIP, IT'S
THE TIME, THE EFFORT, THE
STUDIES THEMSELVES CAN BE VERY
MENTALLY AND PHYSICALLY TAXING
SO I THINK, YOU KNOW WHEN YOU
TAKE ALL OF THOSE THINGS
TOGETHER, I DO THINK THERE'S AN
ETHICAL OBLIGATION TO DO MORE.
>> OKAY.
THANK YOU VERY MUCH.
JENNIFER FRENCH, HAVE YOU A
QUESTION SNO, SORRY ABOUT THAT,
THANK YOU SO MUCH FOR THE TALK,
I REALLY APPRECIATE SHARING THE
WORK THAT YOU'VE DONE IN THE
PAST AND GETTING SOME FEEDBACK
FROM THOSE WITH LIVED
EXPERIENCE.
ONE QUESTION I HAVE IS IN REGARD
TO COMPENSATION, WE ALL GET
SQUIRMY ABOUT THAT AND YOU DID
HIGHLIGHT THE KIND OF PUSH-PULL
THAT HAPPENS IN THAT SPACE BUT
WE HAVE A WEIRD SYSTEM HERE IN
THE U.S. WHERE SOME PEOPLE
CANNOT TAKE CASH COMPENSATION,
SO I'M CURIOUS WITH THOSE THAT
YOU INTERVIEWED THAT ACTUALLY
HAVE HIGH LEVEL DISABILITIES,
DID THAT TOPIC COME UP AND WERE
THERE ANY DISCUSSIONS AROUND IT?
>> CAN I TALK--HE'S THE 1 WHO
DID THE INTERVIEWS MAYBE, YOU
KNOWS OTHER THINGS BUT I THINK
PEOPLE DO RECOGNIZE, LIKE
SOMEBODY SAID IN THE CHAT, TOO,
YOU KNOW FOR SOME PEOPLE, ON
MEDICARE THAT YOU CAN'T TAKE
COMPENSATION AT LEAST ABOVE A
CERTAIN LEVEL OR YOU WILL LOSE
YOUR ELIGIBILITY FOR BENEFIT SO
WE HAVE TO BE CONSCIOUS OF THAT,
I THINK SOME OF THE PARTICIPANTS
AS YOU ALL WERE SAYING
YESTERDAY, TALK ABOUT
COMPENSATION NOT JUST FOR HOURS
WORKED ALTHOUGH PEOPLE SOMETIMES
DO TALK ABOUT IT LIKE IT'S A
JOB, BUT ALSO FOR COVERAGE OF
NEEDS, RIGHT?
SO 1 OF THE PEOPLE TALKS ABOUT
PAYING A PERSONAL ATTENDANT TO
HELP GET HIM THERE AND HE'S
PAYING HER SO MUCH MORE AND HE
GETS THIS TINY LITTLE PITTANCE
OF FUND THAGOREAN DIDN'T EVEN
COME CLOSE TO OFFSETTING THE
BURDEN ON HIM TO GET TO THE
STUDY SITE AND DO THE WORK.
SO I DON'T THINK IT ALL HAS TO
BE DIRECTLY TO HIM, BUT, YOU
KNOW THINKING MORE CREATIVELY
ABOUT WAYS TO MAKE IT MORE
FEASIBLE FOR PEOPLE WHO ARE
OTHERWISE RELATIVELY WEALTHY TO
DO THESE STUDIES SEEMS REALLY
IMPORTANT.
>> GREAT.
I SEE SHIRLEY Mc CARTNEY HAS A
QUESTION?
>> I DO, CAN YOU HEAR ME?
>> YES.
>> I HAVE A QUESTION AND I
COMMENT.
IF AS A STUDY PARTIC PLAN TO
ANALYZE BY AGE YOU RECEIVE MORE
THAN $600 YOU HAVE TO FILE IT
WITH YOUR TAXES AND IT'S
RIDICULOUS, IT'S A LIAISON DICK
LOWS AMOUNT OF MONEY, I
MENTIONED THIS YESTERDAY,
GEOGRAPHY IS A CHALLENGE AND
WHAT I FIND IS THAT WHEN I'M
NEGOTIATING BUJ FETS AND MORE
AND MORE I'M NOT EVEN
NEGOTIATING BUDGETS DIRECTLY
WITH THE SPONSOR, I'M
NEGOTIATING BUDGETS WITH THE
CLINICAL RESEARCH ORGANIZATION
WHO IS WORKING AS A KIND OF
MIDDLE PERSON BROKER AND I'M
SCOTTISH SO I'LL BE REALLY
FRANK, I JUST GET LOW BALLED ALL
THE TIME.
AND PUSH BACK AND COMPENSATION
FOR TRAVEL.
SO I'VE HAD STUDIES WHERE A
THIRD PARTY, A TRAVEL AGENT HAS
BEEN IN CHARGE OF THE TRAVEL
WHICH IS ACTUALLY MUCH EASIER ON
MY STUDY TEAM, OTHERWISE MY
STUDY TEAM IS TAKING A RESEECHTS
FOR HOTELS AND TRAVEL AND FOOD
AND REDACTING THEM AND THATY'S
AGAIN, I WANT TO GET RID OF ALL
THE ADMINISTRATION AS A RESEARCH
ADMINISTRATOR SO THEN THERE'S A
BURDEN ON MY STUDY TEAM TO DO
ADMINISTRATIVE WORK TO ASSURE
THAT SUBJECTS ARE COMPENSATED
AND WE WANT THEM TO BE
COMPENSATED BUT THE $600 LIMIT
IS JUST SOMETHING THAT NEEDS TO
BE CHANGED IN CONGRESS.
AND I HAD 1 OTHER THOUGHT BUT IT
NOW ESCAPED MY BRAIN--OH,
TRAVEL.
WE HAD TO PLEAD AND BEG RECENTLY
FOR A SUBJECT WHO'S COMING OUT
OF STATE FOR A BRAIN TUMOR STUDY
TO GET REIMBURSEMENT FOR THEIR
TRAVEL FEES AND UNBENOUNS TO US,
BECAUSE WE TOOK OVER THE STUDY,
THE PATIENT HAD BEEN PAYING FOR
THE TICKET THEMSELVES AND OF
COURSE AIRLINE COSTS WENT UP SO
THEN AGAIN, I'M
NEGOTIATING--IESM LIKE JUST
PLEASE JUST GIVE US SOILY HERE
TO GET THE PATIENT TO HER
CLINIC.
AND IT'S A LOT OF TYPING ROUND
IN ROUND IN CIRCLES BEGGING FOR
MONEY FOR THE PATIENT'S BEHALF
AND I FEEL LIKE IT'S NOT
SOMETHING WE SHOULD HAVE TO DO.
AND I WOULDN'T BLAME IT ALL THE
TIME WITH THE SPONSOR, A LOT OF
TIMES I'M NOT DEALING WITH THE
SPONSOR, I'M DEALING WITH
SOMEBODY ELSE IN THE MIDDLE
WHO'S TAKING A PERCENTAGE OF THE
MONEY OUT THERE, TOO, WE THANK
AND YOU IT'S JUST INTHG TO THINK
ABOUT.
>> IT'S FANTASTIC AND IT CALLS
OUR ATTENTION, I WOULD SAY IF
WE'RE IN A PANEL WHERE WE'RE
TALKING ABOUT WHAT SHOULD BE, WE
DO WANT TO RECOGNIZE WHAT THE
REQUIREMENTS AND RULES ARE FOR
ELIGIBILITY, NOW, BUT WE DON'T
HAVE TO ACCEPT THOSE RULES WE
COULD AS A GROUP PUSH FOR
CHANGES THERE AND I AGREE IN
THINK BEING HOW TO COMPENSATE
PEOPLE FOR TRAVEL AND CAREGIVER
COSTS AND OTHER THINGS JUST TO
MAKE IT ACTUALLY AN EQUAL
OPPORTUNITY ACCESS KIND OF
THING, WE SHOULD BE DOING THAT.
THIS IS THE PANEL THAT SHOULD.
>> YEAH.
>> SO 1 MORE QUESTION FROM
TRACEY AND THEN WE WILL MOVE ON
TO OUR OTHER SPEAKER.
>> YEAH, I HAD--I THINK I HAD
MORE OF A COMMENT BUT I'M
CURIOUS ABOUT SARA AND--THIS
FEELS LIKE, I LOVE THAT THE LAST
COMMENTER WAS SAYING WE NEED TO
GO TO CONGRESS BECAUSE NOW IF
THERE'S PATIENTS WE DON'T EVEN
KNOW THERE'S SOMETHING TO FIGHT
FOR, IT'S GREAT FOR HAVING THESE
GROUP DISCUSSIONS BUT IT FEELS
LIKE THIS IS A LARGER
CONVERSATION BECAUSE MOSTLY COME
INTO THIS, YOU KNOW THERE'S
THERE IDEA OF ALTRUISM BUT THE
REALITY IN OUR COMMUNITY IS IT'S
DESPERATION, IT'S DESPERATION
FOR SOME SORT OF IMPROVEMENT, WE
HAVE NO OTHER OPTIONS, THAT'S
THE TRIEEVER IN OUR COMMUNITY SO
WE DON'T NECESSARILY FEEL LIKE
WE NEED TO GET PAID BUT THERE IS
AN OVERARCHING PREVAILING
ATTITUDE THAT EVERYBODY'S MAKING
MONEY ON OUR DATA EXCEPT US
RIGHT?
SO IS THIS AN OPPORTUNITY FOR
EDUCATION AND TRANSPARENCY ABOUT
TRIAL COSTS AND RIGHT?
AND THINGS LIKE THAT AND DO YOU
BEING THAT WOULD HAVE SHIFTED,
WAS IT CLEAR TO THE PEOPLE I
WERE SPEAKING TO ABOUT THE
TRANSPARENCY OF TRIAL COSTS AND
WHERE THIS MONEY GOES AND DO YOU
THINK THAT WOULD HAVE SHIFTED
THEIR WAY OF THINKING?
>> ISHAN DO YOU WANT TO SAY IF
YOU THINK--
>> SURE.
I MEAN THE PEOPLE WE SPOKE TO
PRETTY CONSISTENTLY SAID THAT
COMPENSATION ACTUALLY WAS NOT A
FACTOR AT ALL.
I THINK YOU'RE COMPLETELY RIGHT
THAT IT WAS OUT OF DESPERATION,
IT WAS OUT OF TRYING ANYTHING
THAT COULD WORK, IT WAS OUT OF
YOU KNOW THE DESIRE TO
PARTICIPATE IN SOMETHING.
BUT I THINK THAT BEING SAID, YOU
KNOW MOST OF OUR PARTICIPANTS
SAID, HEY, BUT I'M FRONTING A
LOT OF THESE COSTS OUT OF
POCKET.
I'M ACTUALLY AT BEST MAYBE
BREAKING EVEN BUT PROBABLY NOT.
YOU KNOW, ACTUALLY FUNDING A LOT
OF THIS ON MY OWN, AND WHILE
THAT'S NOT, YOU KNOW THAT
WOULDN'T HAVE PREVENTED ME FROM
PARTICIPATING, IT CERTAINLY
SOMETHING THAT THEY THINK ABOUT
AND THEY DEFINITELY THINK THAT
YOU KNOW THERE SHOULD BE MORE
DONE THERE.
>> THANK YOU FOR THE
INTRODUCTION, AM I SUCCESSFULLY
SHARING MY SCREEN?
>> YOU ARE.
>> GREAT.
--I AM GOING TO TALK ABOUT
LARGELY THE MINIMUM WHAT FDA
LOOKS AT OR POST TRIAL
PROTECTION OF PATIENTS AND THEN
TALK ABOUT SOME OF THE POTENTIAL
RISK WE SPOTTED WITH DEVICES,
IMPLANTED DEVICES AND THEN TALK
ABOUT POSSIBLE MEASURES TO
PROTECT THE TRIAL SUBJECTS AFTER
THIS STUDY ENDS.
I THINK I DO HAVE SOMETHING TO
ADD, I DON'T KNOW IF IT WILL BE
VALUABLE, BUT, THE FIRST PART OF
THIS IS WHAT FDA HAS TO SAY.
AND THE SECOND PART IS MY VIEW.
SO DON'T HOLD FDA RESPONSIBLE.
REGULATIONS, I CONSULTED OUR
REGULATORY OFFICE AT CDRH AND
PEOPLE WHO FEEL IN PARTICULAR
WITH THE IDEs, THAT RESULT
THAT ARE THE BASIS FOR THE FDA
APPROVAL OF TRIALS.
AND THE FDA REGULATIONS DO NOT
SPECIFICALLY ADDRESS THE CONCERN
FOR DOWN STREAM ADVERSE EVENT
WHEN IS DEVICES ARE LEFT IN
PLACE AFTER A TRIAL ENDS.
THEY DID MENTION, THOUGH THAT
THERE IS AN FDA GUIDANCE ON
INVESTIGATE RESPONSIBILITY WHICH
STATES THAT SUBJECTS SHOULD
RECEIVE APPROPRIATE MEDICAL
EVALUATION AND TREATMENT UNTIL
RESOLUTION OF ANY EMERGENT
CONDITION RELATED TO THE STUDY
INTERVENTION THAT DEVELOPS
DURING OR AFTER THE COURSE OF
THEIR PARTICIPATION IN THE
STUDY, EVEN IF THE FOLLOW UP
PERIOD EXTENDS BEYOND THE END OF
THIS STUDY AT THE INVESTIGATIVE
SITE.
SO, YOU KNOW THERE'S A LITTLE
HINT IN THERE FOR RESPONSIBILITY
BUT IT'S NOT HARD FOR US TO
CARRY THAT THROUGH AND IMPLEMENT
IT.
IT PLACES THE RESPONSIBILITY
MORE ON THE INVESTIGATOR THAN IT
DOES ON US.
THERE IS 1 INTERESTING PROCESS
THAT GOES ON, IT'S CALLED
MEDICAL DEVICE TRACKING.
AND IT DESCRIBES PATIENT DEVICE
TRACKING FOR CLEARED OR APPROVED
DEVICES AND THESE ARE DEVICES
THAT ARE PRETTY MUCH THE 1S
WE'RE TALKING ABOUT WHEN YOU
TALK ABOUT NEUROLOGY OR
PSYCHIATRY AND THEY ARE THE 1S
THAT WHEN THEY--AFTER THEY ARE
APPROVED FROM MARKETING, THERE
MAY BE SOME LONG-TERM ADVERSE
EVENTS THAT NEED TO BE TRACKED
AND FDA HAS A GUIDANCE ABOUT
WHEN THEY CAN DO THAT AND I
DON'T KNOW ANY EVIDENCE, I
HAVEN'T EXPERIENCED THAT IN MY
YEARS HERE AT CDRH, SO I DON'T
KNOW MUCH DETAILS ABOUT THAT BUT
I WILL TRY TO CIRCULATE THESE
LINKS, THERE'S IDEAS IN MEDICAL
DEVICE TRACK THAGOREAN MIGHT BE
EXTENDED BACKWARD OR FORWARD TO
IDE STT STUDIES, MY FIRST JOB
WAS IN THE ARROW SPACE INDUSTRY,
THESE ARE WHAT ARE CALLED SPACE
DEBRIS, LOTS OF DEVICES UP THERE
CIRCLING THE EITHER, NO LONGER
FUNCTIONING OR RUNNING INTO EACH
OTHER AND CAUSING A LOT OF
PROBLEMS.
I WAS GOING TO POINT OUT WHEN WE
DO THESE IDEs, EXEMPT FORMS
AND OTHER DOCUMENTS, THERE'S
THINGS WE CONSIDER, FIRST OF ALL
SAFE TO EXPORT A DEVICE, IT'S
NOT A GO OR NO GO BUT IT'S
SOMETHING TO THINK ABOUT AS WE
REVIEW IT.
ARE THERE PLANS FOR DEVICE
MAINTENANCE OR REMOVAL AND DOES
THE CONSENT FORM DESCRIBE ALL
THE POTENTIAL RISKS AND I THINK
THIS IS WHERE WE--THERE ARE A
LOT OF PROBLEMS YOU ALL
IDENTIFIED WELL AND WE THERE
ISN'T A SOLUTION AVAILABLE FOR
MANY OF THESE PROBLEMS SO WHERE
WE LEAVE IT IS WE WANT TO BE
SURE THE PATIENT KNOWS ABOUT THE
LONG-TERM CONSEQUENCES OF THESE
RISKS, THE POTENTIAL SAFETY
IMPLICATIONS FOR THEIR LIVES AND
ALSO THE POTENTIAL COST.
AND THEN THE OTHER THING WE
WOULD GET, IS THE POSSIBILITY
RISK BALANCE BY THE POSSIBLE
BENEFIT, AND REVIEW INTERIM AND
FINAL REPORTS TO IDENTIFY
PROBLEMS.
WE HAVE A HARD TIME GETTING
REPORTS ON STUDIES THAT ARE NOT
COMPLETED BUT IT DOES GIVE US A
PICTURE OF SOME OF THE SAFETY
COMPLICATIONS.
I WAS GOING TO GO ON NOW TO MY
VIEWS, LEAVES BEHIND FDA, IN
PARTICULAR, BUT I JUST, YOU
KNOW, SIBS I HEARD ABOUT THIS
CONFERENCE, I'VE BEEN KEEPING MY
EARS OPEN TO THE KIND OF THINGS
WE'VE ENCOUNTERED AS THESE
DEVICES ARE APPROVED OR THINGS
WE HAVE MENTIONED AS
ANTICIPATING WHEN WE APPROVE A
STUDY TO BEGIN FOR DEVICE THAT
ISN'T YET MARKETED.
AND THERE ARE DEVICES THAT THE
ENGINEERS LOOK AT, THE
DEGRADATION OVER THE YEARS,
BATTERY FAILURE, 1 THAT I
HAVEN'T HEARD MENTIONED HERE IS
THAT THAT YOU HAVE A DEVICE
IMPLANTED IN THE BRAIN,
SOMETIMES MRI SCANS ARE EITHER
COMPLETELY IMPOSSIBLE AND IT'S
TURNED OFF AND MRI SCANS OF
BRAIN ARE LIMITED OR IMPONL
EARLY IN LIFE AND THEN HAVE A
DISEASE THAT INVOLVE FREQUENT
MRI SCANS IT CAN HAVE A
SIGNIFICANT EFFECT ON YOUR
HEGHT.
THERE ARE MANY INCREASINGLY,
THERE ARE DEVICES THAT CAN BE
SAFELY REMOVED.
YOUR STORIES THAT PATIENT HAVE A
DEVICE AND THEY DON'T--THEY
DON'T REMEMBER WHAT IT WAS, THEY
DON'T--THEY DON'T HAVE ANY
ACCESS TO THE DEVICE LABELING
AND YOU KNOW, I'VE HEARD OF
PATIENTS ACTUALLY SOME
COLLEAGUES WHO FORGOT TO MENTION
THEY HAD A DEVICE IMPLANTED AND
THEY HAVEN'T HEARD THAT
HAPPENING WITH BRAIN DEVICES,
BRAIN AND SPINAL CORD DEVICES
BUT IF YOU LIVE WITH THESE
THINGS FOR A YEAR, THEY'RE NOT
ALWAYS THAT APPARENT TO YOU.
--YOU KNOW YOU--THERE'S THE LOSS
OF CARE, WE HAVE BEEN VERY
CONSISTENT ABOUT MENTIONING
THAT, FROM WHAT I'VE HEARD.
BUT THERE'S ALSO A RECK
COLLECTION OF THE DESIGN OF
DETAIL AND DEVICE, SO 10 OR 15
YEARS LATER WHEN THE COMPANY'S
OUT OF BUSINESS AND THERE ARE
PROBLEMS THE CLINICIANS DON'T
KNOW WHAT THEY'RE DEALING WITH,
THEY MAY NOT BE ABLE TO FIND THE
NAME OF THE DEVICE OR WHO
MANUFACTURED IT.
DEVICES, THERE ARE DEVICES THAT
YOU GET IDENTIFIED BY IMAGING OR
SCANNING.
THERE'S DEVICES THAT YOU KNOW OF
YOUR--THERE'S THE RISK THAT YOU
WILL GET THE BETA VERSION AND
THEN, WHAT GETS APPROVED IS THE
BETTER VERSION THE PATIENT
PROBABLY NEEDS TO KNOW THAT
THEIR TESTING OF DATA VERSION
AND THEY'RE LIKELY TO BE
IMPROVEMENTS THAT THEY WON'T BE
ABLE TO GET IF THE CURRENT
DEVICE CAN'T BE EXPLANTED OR
CAN'T--CAN'T WORK IN ADDITION TO
ANOTHER IMPLANTATION OF THE SAME
DEVICE.
AND THEN THERE'S--YOU KNOW
THERE'S SIMPLELE THINGS,
EVOLUTION OF OPERATING SYSTEMS
AND AS WE HEARD YESTERDAY, I
MEAN, CD ROMS ARE NOT GOING TO
WORK LOOKING DEFINITELY INTO THE
FUTURE.
POSSIBLE, I WAS GOING TO GO
AHEAD AND TALK ABOUT THOUGHTS
THAT CROSSED MY MIND, POSSIBLE
MEASURES TO PROTECT TRIAL
MEASUREMENTS AFTER THE STUDY
ENDS.
AND I HEARD THIS YESTERDAY, AND
I CAN'T TELL YOU HOW MUCH, I
THINK IT'S IMPORTANT TO GIVE
PATIENTS A VOICE INDEPENDENT
FDA, MANUFACTURES AND
INVESTIGATIONS FOR THEIR
DEVICES, YOU KNOW, IT'S HARD,
WHEN YOU'RE REVIEWING YOU OFTEN
GO TO SEE WHAT ADVERSE EVENTS
THESE PATIENTS ARE REPORTING
THEMSELVES AND THEIR BLOGS AND
IT'S REALLY HARD TO FIND THOSE,
THEY AREN'T READILY INDEXED BY
GOOGLE AND I THINK THAT, YOU
KNOW THAT NEEDS TO BE DONE
SOMEHOW.
CERTAINLY--I DON'T THINK IT'S A
ROLE OF FDA IN FACT, PROBABLY
FDA SHOULD BE INDEPENDENT OF IT,
INDEPENDENT OF THE MANUFACTURE
AND INVESTIGATORS, SO THAT--IT
COULD BE A FREE EXCHANGE.
BUT, PERSONALLY I'VE BEEN DOING
CLINICAL TRIALS FOR ALMOST MY
WHOLE PROFESSIONAL LIFE AND I
HAVE JUST WATCHED THEM GET MORE
AND MORE COMPLICATED MORE AND
MORE EXPENSIVE AND THE DISTANCE
BETWEEN INVESTIGATORS AND
PATIENTS NOT NECESSARILY AND THE
SPONSORS GETTING MORE AND MORE
JUST COMPLICATED AND DIFFICULT I
THINK THERE NEEDS TO BE A
RESETTING WHERE WHERE WE CHANGE
THE WHOLE ORGANIZATION AND START
INVOLVING PATIENTS IN THE
BEGINNING.
IF THE PATIENTS DON'T UNDERSTAND
THE DESIGN OF THE STUDY AND HOW
IMPORTANT IT IS TO DO THINGS
THAT MAY NOT SEEM RELEVANT TO
THEIR HEALTH IN ORDER TO GET THE
ANSWER, THE STUDY TO BE
SUCCESSFUL, AND ANSWER THE
QUESTION, IT'S JUST NOT GOING TO
HAPPEN AND WE'RE GOING TO END UP
WITH POOR QUALITY RESULTS THAT
ARE HARD TO INTERPRET.
THERE'S NOTHING MORE BURDENSOME
TO A SPONSOR THAN TO FINISH A
STUDY AND FIND OUT THAT THERE
ARE SOME MANY DROP OUTS AND SUCH
POOR DATA QUALITY, THAT FDA
CAN'T DESIGN WHETHER THEIR
DEVICE IS EFFECTIVE OR NOT.
I AM GOING TO BEGIN TALKING MORE
WITH MY ENGINEERING COLLEAGUES,
IT SEEMS TO ME AT THE BEGINNING
WE COULD BE DESIGNING DEVICES
FOR SAFE AND EASY REMOVAL I
REALIZE THAT WON'T ALWAYS BE
POSSIBLE BUT CERTAINLY WE SHOULD
THINK ABOUT IT WHERE THEY HAVE
AN IMPLANTED DEVICE AND THEY
HAVE LEADS, THEY HAVE ELECTRODES
AND THEY HAVE WIRES, LEADS, AND
THEN THE DEVICE THAT'S
IMPLANTED, AND THEY'RE
CONNECTED.
AND THEY DON'T HAVE THE
EQUIVALENT OF USB CONNECTORS OR
OR SO ON, EACH DEVICE HAS A
DIFFERENT CONNECTOR AND YOU KNOW
DIFFERENT CONNECTORS TO THE
BATTERY AND SO, I DON'T REALLY
KNOW THAT EFFORTS HAVEN'T BEEN
MADE TO STUDY, TO START MAKING
INDUSTRY STAND--INTERCHANGEABLE
PARTS ESPECIALENTIALLY BATTERIES
AND CONNECTIONS, YOU KNOW.
WOULDN'T BE NICE IF IPHONES HAD
BATTERIES THAT YOU COULD
REPLACE, I DON'T KNOW.
HAVE SOURCES OF EXTERNAL
COMPONENTS, FOR THOSE THAT ARE
LOST OR DAMAGED OR AVAILABLE,
AND AFTER THE DEVICE IS NOT
MARKETED AND NO LONGER
MANUFACTURED AND SOMEHOW, YOU
KNOW WHEN YOU'RE PLANNING THE
BETA VERSION OF A DEVICE, BE
THINKING ABOUT WELL, HOW ARE YOU
GOING TO IMPLEMENT IMPROVEMENTS,
WHAT, YOU KNOW WHAT CONNECTIONS,
WHAT WAYS DO YOU HAVE OF
UPGRADING THE SOFTWARE DEVICE.
HAVE A DEVICE IEE, AUDIENCE
DENTIFICATION NUMBER ON THE
DEVICE.
BE SURE TO HAVE AN IMMORTAL
WEBSITE FOR DEVICES AND
REPLACEMENTS CAN BE PRODUCED,
PROVIDE FOR EASY RECOGNITION AND
THE DEVICE SOFTWARE VERSION
MANUFACTURING, MANUFACTURER
STOPS THE WORK, PROVIDES
RESOURCES FOR PRECISION, FOR
PATIENTS FOR CARE AFTERSTUDY AND
CONTACT WITH INVESTIGATORS THAT
ARE LOSS AND FEW I'M MENTIONING,
AND THE LAST 1 ARE BASICALLY YOU
KNOW INTERNET, WEB-BASED
RESOURCES.
MAIP TIANYL A RESOURCE EVENT
THAT IDENTIFIES IT AS A PLANET
FOR EACH PATIENT AND PROVIDE IT
CONNECTS TO THE LABELING AND IF
YOU HAVE A PILL, YOU CAN TAKE A
PICTURE OF IT AND I'M
ENCOURAGING THE GROUP TO STOP
THINK BEING INDIVIDUAL SOLUTIONS
TO THIS PROBLEM, BECAUSE IT'S
VERY AND I THINK THERE ARE THESE
IN THE DRUG WORLD THAT COMPANIES
OF ALL SIZES HAVE COME TOGETHER
AND FORMED WAYS TO ACCOMPLISH
THE SOLUTION OF THESE PROBLEMS
WHICH, YOU KNOW IT'S A PROBLEM
TO THEM AS WELL, BUT AN
INDEPENDENT NATIONAL GROUP AND
ACKNOWLEDGE THE INDIVIDUAL
MANUFACTURE INSTITUTION
INVESTMENT CAN'T SOLVE THESE
PROBLEMS.
THE OTHER 1 TO BE CONCERNED
ABOUT IS THERE'S A BIT OF
SALESMANSHIP GOING ON HERE AND
PEOPLE PEOPLE WHAT UPSETS THEM
THE MOST IS A SURPRISE, FINDING
OUT, SOMETHING HAPPENED THAT
THEY WEREN'T TOLD ABOUT OR WERE
NOT ADEQUATELY INFORMED ABOUT
HOW SERIOUS IT IS AND
SO--ADEQUATE BEFORE THAT AND I
WOULD LIKE TO THINK FROM THE FDA
POINT OF VIEW THAT WE HAVE THE
MAXIMUM POSSIBLE SOLUTION TO THE
PROBLEM, IT MAY NOT BE ABLE TO
AVOID ALL THESE LONG-TERM
COMPLICATIONS ABOUT YOU IT
CERTAINLY CAN BE WORKING
PROACTIVELY TO ANTICIPATE AND
AVOID THEM.
I WAS SORRY TO HEAR THAT
CLINICALTRIALS.GOV ISN'T
NECESSARILY THAT PATIENT
FRIENDLY, BUT I THINK THAT
COMPANIES CAN MAKE VOLUNTARY
ADDITIONS SORE MAYBE EVEN CREATE
A WHOLE NEW DEVICE OR NEW
WEBSITE WHERE THIS INFORMATION
ABOUT THEIR DEVICES COULD KIND
OF BE PUT ONLINE IN PERTUITY AND
WIDELY ACCEPTABLE FOR THOSE WHO
OR EVEN DEVICES THAT ARE
APPROVED OR STILL UNDER
INVESTIGATION TIME FRAME.
I IMAGINE AT LEAST FOR A WHILE
IT WOULD HAVE TO BE VOLUNTARY.
EVENTUALLY, I BELIEVE THE LAWS
ARE MOVING TOWARD SPONSORS OF
MARKETED DEVICES HAVING TO
PROVIDE THE DATA FOR THEIR
STUDIES.
WE'RE SEEING THAT MORE IN THE
JOURNALS.
BLUE ACKNOWLEDGE THE LIMITED
CAPABILITIES OF THOSE MANAGING A
SINGLE TRIAL AND MUCH MORE IS
NEEDED TO PROVIDE MAX NUM
SAFETY, COST LIMITATIONS COME
UP, THE CONCERN SHOULDN'T-HEVER
OR DOESN'T SHIFT FROM PATIENT
WELFARE TO INVESTIGATOR OR
MANUFACTURE WELFARE, ALWAYS
THINK OF TERMS OF PATIENT
SAFETY.
AND THIS IS MY DEPICTION OF ALL
THE DEVICES WE HAVE ORBITING THE
EARTH.
MANY OF THEM UNIDENTIFIED MANY
OF THEM NO LONGER USEFUL AND YET
IN THE WAY OF PROGRESS THAT'S
ADEQUATE AND THAT'S WHAT I HAD
ON MY MIND.
THANK AND YOU THAT'S ALL I HAVE
TO SAY.
>> THANK YOU SO MUCH.
DO HAVE A QUESTION FOR
DR. MARLER?
>> THIS IS A RELIEF, I THOUGHT I
VALID TO DEFEND THE FDA SO MEAS
GO TO TO OTHER PEOPLE'S
QUESTIONS.
>> SO I GUESS I HAVE A QUESTION.
AND I CAN START WITH YOU ABOUT,
WE'RE GOING TO ASK IT TO THE
ENTIRE PANEL NEXT, SO, I
APPRECIATE YOUR POINT ABOUT THE
MIN NUM, BUT I THINK WE DO KIND
OF NEED TO START SOMEWHERE, WE
HAVE A WHOLE LIST OF NEEDS THAT
WE'VE IDENTIFIED AND WE HAVE TO
START SOMEWHERE WHERE, MAYBE WE
SHOULD START WITH SOME OF THE
MOST IMPORTANT 1S.
SO WHAT'S YOUR TWO-CENTS, WHERE
WE MIGHT START BECAUSE IT'S
IMPORTANT BECAUSE IT'S LOW
HANGING FRUIT?
>> WELL, I'VE BEEN THINK BEING
THIS FOR DECADES.
YOU KNOW I DID WHAT WAS THE
PROJECT LEADER FOR A VERY
SUCCESSFUL SERIES OF CLINICAL
TRIALS THAT DEVELOPED THE FIRST
TREATMENT FOR ACUTE STROKE.
[INDISCERNIBLE] THERAPY AND I
WAS INVOLVED IN EVERY NIESH H
FUNDED, ANY NEUROLOGY INSTITUTE
FOR KLINEAL TRIAL AND IT WAS
FUND TO UP THROUGH 2010, SO, I
GUESS TO ANSWER YOUR QUESTION
ABOUT THE MINIMUM, WHAT I HAVE
LEARNED IS IF YOU DRIEB WHAT
YOUR VISION IS, MAKE A PICTURE,
MAKE A MOON SHOT OF IT, IT
BECOMES MORE APPARENT, WHAT ARE
THE INTERMEDIATE STEPS?
BUT RIGHT NOTICE WE HEARD
DESCRIBE THE DIFFICULTIES
CONFRONTING CLINICAL TRIALS,
THEY'RE INCREASING LACK
OF--INCREASING LACK OF KREDET
ENHANCEMENT INTELLECTUAL OF
THEIR RESULTS EITHER BECAUSE OF
THE POOR CONDUCT OR POOR DESIGN
OF THE STUDIES BUT, AND--FOR
WHATEVER REASON AND I THINK THAT
THE MOST IMPORTANT THING I HEARD
TODAY WAS GETTING PATIENTS
INVOLVED FROM THE BEGINNING.
THEY WILL TELL YOU WHEN YOU'RE
DESIGNING THE TRIAL, WHETHER
IT'S WORTH THE RISK OF NOT
HAVING A DEVICE IN YOU THAT YOU
CAN NEVER HAVE TAKEN OUT AND IT
MAY NOT WORK, YOU KNOW?
AND MAKE THAT AND HOW TO--HOW TO
DETERMINE HOW TO GET THEM TO
PARTICIPATE IN THE TRIAL AND
MAKE THE TRIAL WORK.
AND I JUST DON'T SEE THAT
HAPPENING.
I THINK THAT'S ALL I HAVE TO
SAY, THINK ABOUT AND GET THE
INDIVIDUALS THAT WILL BE USING
THE DEVICES HELPING YOU FIGURE
OUT HOW TO GET TO YOUR GOAL,
WHAT THEIR IMMEDIATE STEPS ARE.
I WAS INVOLVED IN A PROJECT THAT
USED SOMETHING CALLED HUMAN
CENTERED DESIGN.
IT ATTEMPTED TO DO EXACTLY WHAT
I WAS TALKING ABOUT, IT WAS DONE
UNDER CONTRACT WITH NINDS, IT
DIDN'T GET SUSTAINED FUNDING BUT
THE ORGANIZATION OF PARENTS AND
FAMILY PUT TOGETHER, AND I THINK
15 YEARS LATER, TURNED OUT TO BE
THE ORGANIZATION THAT RAN THE
CLINICAL TRIAL; THE VERY
RIGOROUS CLINICAL TRIAL THAT WAS
USED TO GET A NEW TREATMENT FOR
S MA APPROVED, [INDISCERNIBLE],
SO IT--I THINK THERE IS SOME
SUGGESTION THAT IT HAS SOME
POSITIVE OUTCOMES.
>> SO I WOULD LIKE TO INVITE ALL
THE PANELISTS FROM PANEL 3 TO
TURN ON THEIR CAMERAS AND BE
READY TO HAVE A DISCUSSION ABOUT
THE THINGS THAT WE WERE FOCUSING
ON, WHAT SHOULD BE PROVIDED AND
WHEN SHOULD SOMETHING BE ABOVE
THE MINIMUM, BUT BEFORE WE TURN
TO THAT DISCUSSION, I HAVE 2
HANDS UP THAT I SEE SO I WILL
CALL ON THOSE 2 AND THEN TAKE IT
FROM THERE.
SO, I CAN'T TELL WHO WAS FIRST,
I BELIEVE CAROLINE WAS FIRST AND
THEN JENNIFER FRENCH.
>> YES.
>> CHRISTINE AND MY QUESTION IS
FOR DR. MARLER, THANK YOU FOR
YOUR TALK DR. MARLER, I WAS
CURIOUS TO HEAR, I READ LAST
YEAR ABOUT A PROPOSED FDA
NEUROSCIENCE CENTER OF
EXCELLENCE, I THINK THE AMERICAN
BRAIN COALITION WAS INVOLVED IN
HELPING TO ADVOCATE FOR THIS, I
WAS CURIOUS TO HEAR, WHETHER YOU
KNOW ANYTHING ABOUT THE STATUS
OF THIS CENTER, AND IF SO,
WHETHER THE AIMS FOR THIS WOULD
BE ABLE TO ADDRESS SOME OF THE
CONCERNS IN THE CLINICAL TRIAL
ISSUES THAT WERE BROUGHT UP
TODAY AND YESTERDAY, RANGING
FROM DESIGN TO POST TRIAL CARE?
I WOULD BE CURIOUS.
>> YOU'RE ON MUTE.
>> SORRY.
I'M NOT AWARE OF ALL OF THOSE
PROGRAMS GOING ON, THERE ARE A
LOT OF EFFORTS TO TRY TO INVOLVE
PATIENTS.
MYSELF AND MY CAREER, THE FDA
AND THE NIH, I REALLY HAVE MADE
THAT 1 ATTEMPT I DESCRIBE WIDE
YOU IN CENTERED DESIGN BUT IT'S
VERY HARD TO REACH OUT AND GET
PATIENTS UP FRONT IN THE DESIGN
AND CONDUCT OF CLINICAL STUDIES.
SHOULD--I GUESS IT COULD BE
DONE, BUT I'M NOT AWARE OF ANY
PRESENTLY IN THE GOVERNMENT TO
DO THAT.
>> THANK YOU.
>> SO JENNIFER DO YOU HAVE I
QUESTION FOR DR. MARLAER OR THE
OTHER PANELISTS.
I.
>> SURE, I CAN DIRECT IT TO
DR. MARLAER BUT OTHER PANELISTS
CAN WEIGH IN AS WELL, THANK YOU
IF ARE SHARING YOUR THOUGHTS TO
YOU AND THE FDA, BUT HATS OFF TO
CDH FOR PUTTING OUT GUIDANCE
LAST YEAR TO PATIENT ENGAGEMENT.
SO, IT'S NICE TO SEE THAT THE
FDA IS MY GUIDANCE SAID IT'S
VOLUNTARY, AND THE PROCESS OF
DEVELOPING MEDICAL DEVICES, WISH
IT WAS MORE MANTATORY, SO MY
QUESTION TO YOU AND THE REST OF
THE PANELISTS ARE, YOU MENTIONED
IN SOME OF YOUR COMMENTS AT THE
END OF THE TALK ABOUT HOW THE
DRUG WORLD HAS COME AND THE DRUG
INDUSTRY AND INVESTIGATORS CAME
TOGETHER TO SOLVE THESE HARDER
PROBLEMS WITH EARLY STUDIES AND
I'M CURIOUS IF HAVE YOU OPINIONS
OR ANY INSIGHT OF LESSONS
LEARNED FROM THE DRUG INDUSTRY
THAT WE MIGHT BE ABLE TO BLEED
OVER TO MEDICAL DEVICES?
>> I WAS WITH CDER FOR DRUGS
BEFORE I CAME TO CDRH, BECAUSE
OF MY INTEREST IN STROKE AND
STROKE DEVICES.
NO, I JUST HAD THE SAYING THAT I
WAS AWARE SO YOU KNOW WHEN YOU
GO OUT THERE AND THEY'RE IN
WEBSITES, RUN BY I THINK
THERE'S--THERE ARE MAYBE PHARMA,
MAY BE THE NAME OF THE
ORGANIZATION BUT THERE ARE
WEBSITES OUT THERE THAT PROVIDE
INFORMATION ABOUT DRUGS THAT ARE
INDEPENDENT OF THE FDA WEBSITE.
I DON'T KNOW THAT THAT'S USEFUL
OR ANYTHING, HOW ELSE DO THEY
BECOME ACTIVE.
I THINK THEY PARTICIPATE IN
DIALOGUES AS IN SETTING OUT IN
MEETINGS AND THEY RESPOND TO
DRAFT GUIDANCES FROM FDA AND SO
ON, SO I DON'T KNOW THAT MUCH
ABOUT IT, I'M SORRY, WHEN YOU'RE
AN FDA EMPLOYEE, YOU'RE
INSULATED FROM THESE
ORGANIZATIONS, APPROPRIATELY SO.
>> MAYBE WE CAN INVITE OTHERS TO
TURN ON THEIR CAMERAS AND JOIN
US IN THIS DISCUSSION.
>> I PUT IN THE CHAT THE LIST
THAT NINA PRESENTED EARLIER THIS
MORNING, IN PANEL 1, YESTERDAY,
AND I JUST WOULD LIKE TO
ENCOURAGE US ALL TO THINK ABOUT
DO WE NEED LIKE SHOULD WE
COVER--DO WE NEED TO COVER ALL
OF THESE NEEDS IN ALL TRIALS OR
ARE SOME OF THEM PERHAPS MORE
IMPORTANT THAN OTHERS, FOR
EXAMPLE, MAYBE IT'S ESPECIALLY
IMPORTANT TO INSURE THAT IT'S
COMPATIBLE HARDWARE BECAUSE IF
IT SUBJECT THAT'S THE END OF THE
STORY FOR SOME, WHERE SOME
PATIENTS HAVE DIFFERENT
OPPORTUNITIES TO TRY TO PURSUE A
CERTAIN GOAL OR MAYBE WE WANT TO
PRIORITIZE SOME OF THE ITEMS ON
THIS LIST THAT RELATE TO HARMS
THAT COULD COME TO PATIENTS.
I JUST WANT TO ENCOURAGE THE
PANEL TO REFLECT A LITTLE BIT ON
THIS LIST AND SEE.
CAN WE TAKE THIS BEYOND THE
HIGHER LEVEL PRINCIPLES THAT
WE'VE ALL BEEN AGREEING UPON FOR
YEARS, AND TRY TO GET A LITTLE
BIT MORE SPECIFIC.
I CAN START SINCE NOBODY'S ELSE
IS STARTING, 1 TECHNOLOGY
TRANSFER THAT STRIKES ME BECAUSE
WE ARE VERY DIFFERENT PEOPLE
THAT ARE IN THE STUDY THAN THE
PARTICIPANTS FROM YESTERDAY IS
THAT WHEN PEOPLE ARE GETTING A
CLINICAL BENEFIT, AND A LIFE
SAVING CLINICAL BENEFIT, THAT
HAS TO BE OUR PRIORITY,
IT'S--YOU KNOW THE BCI STUDY
PARTICIPANTS WHO USE THE DEVICE
IN THE LAB HAVE A LIFE ALTERING
EXPERIENCE AND THEY, YOU KNOW
GAIN A LOT OF MEANING AND
PURPOSE AND THAT SORT OF THING
FROM THE STUDY AND I THINK WE
HAVE TO REALLY PAY ATTENTION TO
THEIR TRANSITION OUT OF THE
STUDY WHEN THEY DON'T HAVE THE
ROBOTIC ARM OR THE CAPACITY TO
USE THE DEVICE AT HOME.
I THINK WE HAVE TO PAY ATTENTION
TO, YOU KNOW ACCORD NATION OF
CARE AFTER THAT JUST LIKE
PSYCHOLOGICAL SUPPORT AND
LEAVING AND ALL THOSE SORTS OF
THINGS BUT I THINK THE PRIORITY
HAS N BE O KEEPING THE PEOPLE
WHO HAVE ACCESS TO LIFE, TO
DEVICES THAT ARE LIFE CHANGING
AND IN AN ONGOING WAY, SO LIKE
GENERATED FER TALKED ABOUT
YESTERDAY AND BRANDY TALKED
ABOUT YESTERDAY, 1 OF OUR
PARTICIPANTS, I THINK WITH ISHAN
WAS ASKING ABOUT THE POSSIBILITY
THAT THE DEVICES IS NO LONGER
AVAILABLE WHETHER THE COMPANY
GOES UNDER OR THE STUDY ENDS,
YOU KNOW IT'S REMARKABLE TO
LISTEN TO THE AUDIO RECORDING
BECAUSE THEY'RE JUST CRICKETS AS
IF THIS PERSON HAS NEVER HAD THE
THOUGHT THAT THIS THING THAT IS
LIFE SAVING COULD BE JUST GONE,
RIGHT?
IT MIGHT NOT BE SUSTAINABLE AND
YOU KNOW THAT TO ME HAS TO BE
OUR PRIORITY.
I DO THINK THERE ARE REALLY
SIGNIFICANT ISSUES ABOUT THE
OTHER DEVICE TRIAL MEMBERS AND I
THINK WE JUST, YOU KNOW SOME OF
IT IS THINKING ABOUT HOW WE
SHIFT SOME OF THE RULES AND
REGULATIONS THAT ARE OUT THERE
AROUND HOW TO SUPPORT PEOPLE WHO
ARE IN THESE STUDIES.
SO THAT EVEN IF IT'S NOT
MONETARY COMPENSATION AS IN PAY,
IT'S FACILITATING WHAT THEY NEED
IN ORDER TO BE ABLE TO
PARTICIPATE WITHOUT BEARING THE
COST.
THEY'RE ALREADY BEARINGA I LOT
OF COSTS IN TAKING ON THAT RISK
AND I DON'T THINK IT'S--WE DON'T
HAVE SYSTEMS THAT RECOGNIZE THAT
NOW, SO I THINK WE HAVE TO
PRIORITIZE THOSE THINGS.
>> TYLER?
>> OKAY, LET'S SEE, I HAVE AM
JUST TRYING TO ABSORB EVERYTHING
AND I CHARGED BY BATTERY LAST
NIGHT SO HOPEFULLY IT'S WORKING
PRETTY WELL, BUT I FEEL LIKE
I'VE BEEN VERY FORTUNATE IN THE
PAST 3 YEARS WITH MY EXPERIENCE
BECAUSE AGAIN, DR. RI VA POSSE,
PRETTY MUCH SAVED BY LIFE, I HAD
HIM ON SPEED DIAL AND IF
QUESTIONS OR CONCERNS I COULD
ASK HIM WITH THAT AND I FEEL
REALLY FORTUNATE.
I'M 1 OF THOSE PEOPLE FOR A
COUPLE DAYS AGO OR IN THE
PREMEETING, I THOUGHT, WHAT IF
THEY STOP MAKING THIS, WHAT IS
GOING ON?
SO I THINK HAVING A REGISTRY OF
THE TECHNOLOGY JUST LIKE YOU DO
MEDICATION WOULD BE EXTREMELY
VALUABLE.
AND I ALSO THOUGHT ABOUT, AGAIN,
WILLINGNESS, YOU KNOW, AGAIN
BRANDY HAD MENTIONED HER
WILLINGNESS AND YOU KNOW TO GO
THROUGH THESE STUDIES AND A LOT
OF PATIENTS WITH TREATMENT
RESISTANT DEPRESSION HAVE BEEN
THROUGH THE RINGER AND I'VE HAD
DISCUSSIONS WITH A LOT OF PEOPLE
WHO HAD ISSUES WITH DEPRESSION
AND THEY'RE LIKE, YOU HAD BRAIN
SURGERY THAT,'S CRAZY, WELL IT'S
THAT OR DIE.
FOR ME IT'S A NO BRAINER BUT FOR
A LOT OF PATIENTS IT'S LIKE ARE
THEY WILLING TO GO THROUGH IT,
AND I THINK THAT WILLINGNESS
WOULD CHANGE, IT WOULD BE
IMPACTED IF AGAIN, MORE AND MORE
DATA AND MORE REASSURANCE WOULD
BE HEY, YOU'RE NOT ALONE IN
THIS, WE'RE GOING TO HELP TAKE
CARE OF THINGS, AGAIN
FINANCIALLY, YOU KNOW WE WILL
OFFER YOU AGAIN THAT
PSYCHOLOGICAL CARE, I HAVE BEEN
SO BLESSED TO HAVE THE TEAM THAT
I DO THAT HAS BEEN ABLE TO OFFER
THAT.
I'VE NEVER FELT LIKE I WAS ALONE
IN THIS OR THAT AFTER THE
SURGERY, OR AFTER IT'S ALL SAID
AND DONE, ALL RIGHT, KICK YOU TO
THE CURB.
YOU KNOW MY FATHER AND I HAVE
HAD MANY CONVERSATIONS WITH
DR. RIVA WHERE WE JUST CALL
INDEED AND SAID, HEY THIS IS
WHAT'S GOING ON HE'S BEEN THERE
TO OFFER A SOLUTION OR BEEN
WILLING TO HELP IN ANY WAY THAT
HE COULD.
AND THEN, AGAIN, IS PARAMOUNT.
JUST LIKE ANYBODY GOING THROUGH
ANY KIND OF ILLNESS, IT'S THAT
SUPPORT SYSTEM AND BEING ABLE TO
OFFER THAT FROM THE GET-GO AND
SAY, LOOK, THIS IS WHAT IT IS,
INSTEAD OF A--KIND OF A BLAND,
ALL RIGHT, WE WILL TRY THIS, WE
HAVE GOOD RESULTS, WE WILL LET
YOU KNOW, I THINK IT'S EXTREMELY
IMPORTANT.
I LOLLED --WOULD LOVE TO HEAR YE
AND TRACEY'S TAKE IF IN THE
PROCESS, ANYONE WAS TO LAY OUT
THE LIFE LONG NEED FOR SURGERIES
AND BATTERY REPLACEMENTS AND
OBLIGATIONS SOLESTIMATE THAD
ENSEL AND ALL THAT STUFF, HOW
WOULD YOU DEAL WITH THAT ON THE
FRONT END?
DO YOU SEE WHAT I'M ASKING?
MAYBE TRACE SCHESTART AND TYLER
CAN JUMP IN, I ALREADY SPOKE,
TRACEY GO FIRST.
>> OKAY, THANKS, TYLER.
YEAH, I MEAN I THINK IT'S A
FRONT END, YOU HAVE TO.
WE ETHICALLY HAVE TO HAVE THAT
CONVERSATION AND SO MAYBE IT'S
NOT THE VERY FIRST CONVERSATION,
MAYBE THE INFORMED CONSENT
CONVERSATION IS THAT WE'RE GOING
TO BE HAVING THIS CONVERSATION
WITH YOU, BUT THERE ARE ISSUES
THAT RELATE TO TRANSITION OF
THIS AND THESE ARE THE THINGS
THAT MIGHT ARISE AND RATHER THAN
GOING THROUGH RIKE THE WHOLE
PLAN, RIGHT?
BUT THESE ARE THE ISSUES BUT I
DON'T--I DON'T THINK THAT WE CAN
GET AWAY WITH NOT DOING THAT NOW
THAT WE'VE HEARD THAT WE HAVE TO
DO THAT.
TYLER DID YOU WANT TO?
I HAD ANOTHER COMMENT BUT I
WANTED TO WAIT FOR TYLER WITH
THIS CONVERSATION.
>> AGAIN, WITH MY EXPERIENCE,
DR. RIVA, POSSE AND DR. MAYBURG,
THE MENTAL STATE I WAS IN I
COULDN'T ABSORB EVERYTHING, I
KNEW WHRAFS ANYTHING ON AND I
HAD GIVEN MY CONSENT FOR
EVERYTHING BUT I WAS FORTUNATE
TO HAVE THE SUPPORT SYSTEM OF
THE FAMILY SYSTEM OF MY FATHER
AND MOTHER PRESENT.
SO AGAIN, FROM WHAT I RECALL,
EVERYTHING WAS KIND OF LAID OUT
FLAT FOR ME, THIS IS WHAT WE'RE
GOING TO BE DOING, THAT WILL
LAST--YOUR BATTERY WILL LAST
X-AMOUNT OF TIME.
IT WILL NEED TO BE CHANGED OUT.
AND WE WILL CROSS THAT BRIDGE
WHEN WE COME TO IT AND SURE
ENOUGH WHEN I HAD TO HAVE IT
CHANGED OUT I WAS SO CONCERNED
LIKE OH GOSH WHAT'S MY LIFE
GOING TO BE LIKE WHEN THIS THING
DAYS?
WILL I COMPLETE LE REVERT?
WHEN AGAIN WHEN I TALKED TO
DR. RIVA, WE WILL GET YOU IN
QUICK AND YOU HAVE PLENTY OF
TIME AND SPACE BETWEEN THE
BATTERY CHANGE WHERE YOU'RE NOT
GOING TO BE DEGRADE IF YOU WILL
BACK TO THAT FORMER MENTAL AND
EMOTIONAL STATE AND AGAIN I WAS
PROMPTLY TAKEN CARE OF.
AGAIN, THIS IS JUST MY OWN
EXPERIENCE.
I KNOW IT HAS NOT BEEN THE SAME
FOR OTHERS JUST FROM LISTENING
AND I KNOW IT'S NOT ALWAYS THE
CASE BUT THAT'S REALLY JUST MY
EXPERIENCE WITH IT.
BUT I DO VALUE THAT AND IT'S
EXTREMELY EXPRNT I CANNOT
IMAGINE NOT HAVING THAT.
, TRACEY DID YOU WANT TO MAKE A
DIFFERENT POINT UNLESS DR. RIVA
POSSE WANTED TO RESPOND, I
WASN'T SURE IF YOU HAD YOUR
FINGER UP.
>> YES, SORRY, I DON'T KNOW IF
DR. DIXON-SALAZAR HAS SOMETHING
ELSE TO SAY, BUT YOU KNOW THE
CONSENT PROCESS IS ESPECIALLY IN
IMPLANTABLE NEUROMODDULATION
DEVICES, SOMETHING WE TAKE VERY
SERIOUSLY.
AS SERIOUSLY AS 1 CAN TAKE IT,
IT'S NEVER A 1 TIME DEAL IN
WHICH ALL QUESTIONS ARE ANSWERED
AND ALL DOUBTS HAVE BEEN CLEARED
BECAUSE THERE WILL ALSO BE A
PARTICULAR SCENARIO OR DOUBT
THAT WILL COME UP MANY TIMES,
YOU KNOW YEARS LATER YOU KNOW,
AND THE CONSENTS PROCESS TO ME
IS NOT JUST AND WE REQUIRE, WE
STRONGLY ENCOURAGE PATIENTS TO
COME WITH LOVED 1S, ADVOCATES,
FRIENDS, USUALLY FAMILY TO
DISCUSS EACH CASE.
WE GIVE THEM COPIES, IN ADVANCE
FOR THEM TO READ AND REGARDLESS,
AS MUCH AS I CAN, YOU KNOW
DEDICATE AFTER EACH PHOTOGRAPH
AN OPENING FOR CLARIFICATION,
THERE WILL ALWAYS BE ASPECTS
THAT WILL BE ADDRESSED LATER,
YOU KNOW AND I WILL HAVE TO SAY,
HEY, WE TALKED ABOUT THIS IN THE
CONSENT.
THE--IT'S A FRAGILE SITUATION IN
WHICH PATIENTS ARE ASKED TO
PARTICIPATE IN A CLINICAL TRIAL
BECAUSE THEY FAILED EVERYTHING
ELSE.
AND YOU KNOW I HAVE NOT SEEN
PAICIALTS THAT CAME TO THE
CONSENT PROCESS, KNOWING THAT
THERE'S SURGERY AND THEN SAID,
YOU KNOW WHAT THE COMPENSATION
TAKE ME OFF, I WON'T TAKE THE
OPPORTUNITY TO PARTICIPATE IN
THIS TRIAL.
SORE, YOU KNOW I DON'T KNOW
WHAT'S GOING TO HAPPEN WITH
BATTERY REPLACEMENTS LATER ON,
PATIENTS ARE, YOU KNOW IN A VERY
VULNERABLE SITUATION, YOU KNOW,
THEY ARE SUFFERING TODAY, AND
THERE ARE ONLY THINKING ABOUT
THE TODAY, THE TOMORROW, THE
SURGERY, IT'S INCREDIBLY
DIFFICULT TO PUT EVERYTHING INTO
PERSPECTIVE.
I DON'T KNOW, YOU KNOW IF I WERE
ON THE OTHER SIDE, YOU KNOW AND
I'M TRYING TO CAUTIOUSLY BE
LAYING OUT ALL THESE THINGS, YOU
KNOW WE'VE DONE 15 YEARS OF
SURGERIES AND WE LEARN AND 1 OF
THE IMPORTANT THINGS THAT THAT'S
WHY I'M SO THANKFUL FOR HAVING
TYLER AND BRANDY IN THIS PANELS
IS YOU KNOW I OPENLY TELL THE
PATIENTS AND THEIR FAMILIES THAT
WE WHAT--WAKIND WE ARE GOING,
WHEN A PARTNERSHIP TOGETHER.
YOU KNOW?
WE'RE LEARNING, I LEARN FROM
THEM AND THEY MAY GET SOME
BENEFIT FROM THE THERAPY BUT YOU
KNOW IT'S A LIFE LONG
COMMITMENT, COMPLETELY LIFE LONG
COMMITMENT THAT GOES BEYOND AN
ARBITRARY END OF A CLINICAL
TRIAL AND THIS IS WHAT WE'RE
TALKING ABOUT TODAY.
LIFE LONG DISABLING COB DITIONS
WHETHER THERE'S NEUROLOGICAL,
PSYCHIATRIC OR WHATEVER ARE NOT
DECIDED AT THE END AND THAT'S
SIMILAR TO CONSENT, IT'S AN
ONGOING PROCESS, YOU KNOW, SOME
PATIENTS WILL CHOOSE TO STOP
PARTICIPATE NOTHING A TRIAL MANY
YEARS LATER AND THEY WANT TO DO
IT AT THE BEGINNING.
>> THANK YOU.
I FEEL LIKE I SHOULD QUANTIFY Y
STATEMENTS, I THINK WHAT'S MISS
SUGGEST THAT THESE WERE CREATED
TO BE USEFUL TO CERTAIN
AUDIENCES AND THEY'RE OVERSEEN,
RIGHT BY PROFESSIONALS WHO
UNDERSTAND THE SYSTEM.
THEY'RE NOT PATIENT FRIENDLY.
INFORMED CONSENT IS DICTATED
MOSTLY BY THE IRB AND WHATEVER'S
ON CLINICALTRIALS.GOV AND THE
FDA IS DICTATED BY WHAT IT NEEDS
FOR TRIAL INFORMATION BUT IF
YOU'RE TRYING TO RELATE TO A
BROAD RANGE OF PEOPLE WHO HAVE
VARYING EDUCATION OUT THERE,
IT'S NOT BEEN MADE PATIENT
FRIENDLY IT'S NOT IN LAY
LANGUAGE AND IT'S NOT REALLY SET
UP IN A WAY WHERE IF YOU THINK
ABOUT TIKTOK OR YOU THE WAY YOU
WANT TO GO ON IT A WEBSITE YOU
WANT TO BE ADVERTISED TO FOR
YOUR IPHONE SO YOU'RE IN A
CULTURE WHERE PEOPLE ARE
EDUCATED AND USED TO BEING
EDUCATED IN A CERTAIN WAY AND--
>> HOW MANY TIMES DO WE AGREEN
CELLS TO THE TERMS AND
CONDITIONS, GET THIS THING, FIX
THIS, YOU PROMISED ME, I TRUST
YOU JUST DO IT, YOU KNOW AND
YEAH.
>> YEAH, GOOD POINT.
>> LET'S GET US BACK TO THE MAIN
DISCUSSION QUESTIONS IF WE CAN.
ALTHOUGH THIS IS A REALLY
IMPORTANT DISCUSSION AROUND
INFORMED CONSENT.
I THINK, HANK, YOU WERE NEXT,
BUT I DON'T BEING I WILL GO BACK
TO THE DISCUSSION QUESTIONS BUT
THERE'S A FACTUAL QUESTION
THAT'S IMPORTANT TO ME IN THINK
BEING THE NEXT PANEL FOR THE
OPEN FORUM, I DON'T KNOW THE
ANSWER TO IT, I THINK MAYBE
SHOULD OF THE RESEARCHERS
INVOLVED IN RUNNING THESE TRIALS
THAT THEY MIGHT--THE
PARTICIPANTS ARE GETTING BCI OR
DEEP BRAIN STIMULATION FOR VERY
SERIOUS CONDITIONS, WHAT
PERCENTAGE OF PARTICIPANTS DO WE
THINK ARE COVERED BY MEDICARE AS
BEING LONG-TERM DISABLED?
I DON'T EXPECT SOMEBODY TO SAY
63.7% BUT, DO PEOPLE HAVE A
SENSE OF HOW MANY OF THE
PARTICIPANTS, WHETHER IT'S MOST,
HALF, A FEW, HAVE MEDICARE
COVERAGE.
>> AND OUR COMMUNITY IS--SO I
LIVE IN CALIFORNIA, SO
CALIFORNIA HAS CHILDREN'S
SERVICES AND THEN AS SOON AS
THEY REACH THE AGE OF 18,
MAJORITY OF THEM ARE DISABLED
AND ON MEDICARE OR MEDIICAL.
ANYBODY ELSE?
>> I GUESS I WAS CURIOUS ABOUT A
STUDY WE HEARD ABOUT IN CANADA.
IS COST CONSIDERATION THERE WITH
THEIR NATIONAL HEALTH SYSTEM?
>> NOT AS FAR AS I AM CONCERNED.
THERE IS A DIFFERENT APPROACH TO
INVESTIGATOR INITIATED STUDIES,
THAT ARE NOT, YOU KNOW AN EXPERT
ON CANADIAN REGULATIONS BUT, YOU
KNOW THERE ARE--DR. LOZANO WHO'S
A PIONEER AND NEUROSURGEON IN
DEEP BRAIN STIMULATION HAS DONE
A NUMBER OF SMALL CLINICAL
TRIALS, STUDIES IN A WAY, YOU
KNOW THE CLINICAL TRIAL WILL
SOMETIMES CONFUSE THIS IS NOT
SOMETIMES TO TRY TO DEMONSTRATE
AGAINST, YOU KNOW SHAM OR ACTIVE
STIMULATION BUT MANY TIMES PROOF
OF CONCEPT APPROACHES ISSUES
RIGHT?
AND HE'S DONE IT IN ALZHEIMERS
BEILEMMIA, ANOREXIA NERVOSA, IN
DEPRESSION OF COURSE, SO, THE
COSTS THERE ARE MUCH MORE
DILUTED IN THE SYSTEM.
>> SO, YEAH I WAS TRYING TO FIND
AN ANSWER TO THE ORIGINAL
QUESTION WHERE A HUNDRED% OF
PEOPLE ARE ON SOCIAL SECURITY
ESSENTIALLY BUT.
>> BUT NOT IN OUR CASE FOR DEEP
BRAIN STIMULATION.
OF COURSE PEDIATRIC POPULATIONS
MAY HAVE BETTER COVERAGE BUT IN
OUR CASE, A LARGE NUMBER OF OUR
PARTICIPANTS IN DEEP BRAIN
STIMULATION FOR DEPRESSION WERE
NOT ENROLLED IN MEDICARE OR
FLEXIBILITY FOR LONG-TERM
FLEXIBILITY, RIGHT NOW, I
HAVE--I AM INCLUDING PATIENTS
THAT CAN ONLY HAVE MEDICARE FOR
EXAMPLE, FOR THE VAGUS NERVE
STIMULATION WHICH IS, YOU KNOW
JUST SPONSORED IN PARTNERSHIP
WITH THE COMPANY SO PATIENTS CAN
ONLY BE MEDICARE RECIPIENTS AND
THAT, YOU KNOW HAS--I CAN ONLY
RECRUIT PATIENTS FROM THERE,
WHICH YOU KNOW, WOULD GENERATE A
PROBLEM OF COURSE WITH EQUITY
AND ACCESS TO HEALTHCARE, BUT
YOU KNOW IT'S THE SITUATION
GIVEN THE SPONSOR.
>> SO WE ARE GOING TO MOVE ON
BECAUSE WE HAVE 300S UP AND
WE'RE RUNNING OUT OF TIME OF
COURSE, SO BELIEVE GABE WAS NEXT
AND THEN WINSTON AND TRACEY I'M
SORRY IF WE GOT YOU MIXED UP AND
I WILL CALL EVERYBODY BY THEIR
FIRST NAME SO I DON'T CREW UP
AGAIN.
>> YEAH, WINSTON WERE YOU FIRST,
IF YOU WERE FIRST PLEASE GO
AHEAD.
>> OKAY, SO I WILL GO.
SO 2 COMMENTS, 1 GOING BACK TO
THE CHILDREN BUT BRIEFLY, SO AS
I MENTIONED THERE WERE A NUMBER
OF--WE SAW A NUMBER OF PATIENTS
PARTICIPATING IMPLANTABLE DEVICE
TRIALS THAT DID NOT RECALL EVEN
HAVING A CONVERSATION ABOUT
DEVICE MAINTENANCE AND SO I
THINK WE NEED TO--THERE ARE
CERTAIN THING THAT WE NEED TO
PRIORITIZE IN THE CONSENT
PROCESS APPROXIMATE AND WHAT'S
GOING TO HAPPEN A YEAR AND HALF
FROM NOW WHEN THE TRIAL IS OVER,
I THINK IT'S 1 OF THEM THAT'S
VERY IMPORTANT, MAYBE HAVING,
YOU KNOW THE CARE PARTNERS
SOMEONE ELSE THERE, HELPING
THROUGH THAT PROCESS SO THAT
THEY ARE AWARE OF WHAT'S GOING
TO HAPPEN.
I THINK IT'S A REALLY IMPORTANT
PART.
NOW WHAT SHOULD BE THE MIN NUM
COVERAGE, I THINK PARTICULARLY
FOR PATIENT WHO IS HAVE
TREATMENT RESISTANT CONDITION
THAT ARE GOING IN, HAVE NOT
RESPONDED TO ANYTHING AND
THERAPY AND BENEFITING FROM THIS
DEVICE.
THIS IS THE ONLY THING THAT THEY
HAVE AVAILABLE.
I THINK WE NEED TO MAKE SUREAT
E COVER WHATEVER
MAINTENANCE IS NECESSARY.
NOW WHO PAYS I THINK IS THE
QUESTION, OR WE COVER WHATEVER
MAINTENANCE IS NECESSARY UNTIL,
YOU KNOW THE PRODUCT BECOMES
COMMERCIALLY AVAILABLE OR
THERE'S FDA APPROVAL.
OF COURSE THERE WILL BE A NUMBER
OF DIFFERENT GROUPS THAT CAN
CHIP IN, BUT I THINK THIS SHOULD
BE PART OF THE COST OF DOING
BUSINESS, YOU KNOW, IF WE ARE
GOING TO WORK WITH THESE
PATIENTS, THIS IS A COMMITMENT
THAT WE NEED TO MAKE TO THIS
PATIENT POPULATION AND WE CAN'T
JUST BE THINKING ABOUT THE COST
OF THE TRIAL OR FAILING FAST AND
THEN JUST MOVING ON TO ANOTHER
DEVICE, WE NEED TO BE COMMITTED
TO THE PATIENT POPULATION, FIRST
AND THEN IF, I KNOW THIS IS NOT
THE WAY THAT PEOPLE THINK BUT,
YOU KNOW IT'S REALLY IMPORTANT
THAT THE MAINTENANCE OF THAT
DEVICE BE INSURED FOR THE
DURATION OF THIS PERSON'S LIFE
OR UNTIL SOMEONE ELSE CAN COVER
IT IF THEY CAN'T COVER IT
THEMSELVES.
>> GREAT.
WINSTON?
>> THIS MIGHT BE A QUESTION MORE
FOR THE NEXT PANEL, BUT WE'RE
TALKING ABOUT WHAT NEEDS TO BE
PROVIDED WE'RE PROBABLY TALKING
ABOUT WHAT IS OWED TO PEOPLE AND
PART OF WHAT GOES INTO LAWN
MOWER IS OWED TO PEOPLE IS THE
RELATIONSHIP WE BEAR TO THEM, SO
WHEY OWE FROM MY CHILDREN IS
DIFFERENT THAN WHAT I OWE TO MY
PATIENTS AND MY CLINIC AND I
HAVE BEEN LISTENING TO A LOT OF
PEOPLE AND THINKING ABOUT THE
DIFFERENT TERMS THAT WE'RE USING
FOR THE DIFFERENT KIND OF
METAPHORS FOR THE RELATIONSHIP.
SO SOMETIMES WE'RE TALKING ABOUT
PEOPLE WHO PARTICIPATE IN THESE
STUDIES AS TEAM MEMBERS OR
COWORKERS, SOMETIMES WE'RE
THINKING ABOUT THEM AS
VOLUNTEERS THAT,'S COME UP LESS
BUT I THINK AMONG OTHER THINGS,
TRACEY--I'M SORRY THE PANELISTS
YESTERDAY BRANDY AND JEN TALKING
ABOUT HOW A VOLUNTEERIST
APPROACH AFFECTS THE
PARTICIPATION IN THESE STUDIES
SO WE'VE SEEN VOLUNTEERING AS A
WEAKNESS MODEL AND THEN WE
TALKED ABOUT PEOPLE IN THESE
STUDIES AS PATIENTS AND I THINK,
YOU KNOW 1 QUESTION FOR NOW AND
MAYBE 1 QUESTION FOR THE NEXT
PANEL IS WHAT'S THE RIGHT WAY OF
THINK BEING THE RELATIONSHIP
THAT WE STAND BOTH THE
INVESTIGATORS IN THE STUDY AND
MAYBE THE BROADER SOCIETY STAND
IN TO THE PEOPLE WHO ARE ENGAGED
IN THIS VERY LONG RANGE AND IN
SOME CASES HIGH RISK RESEARCH.
SO THAT WAS 1 THOUGHT IN TERMS
OF EMBEDDING THE DISCUSSION AND
THAT MIGHT ALSO RELATE US TO
TURNOVER QUESTIONS ABOUT THE
VIRTUES, I THINK I HAVE BEEN
HEARING ABOUT IN THE CONTEXT OF
WHEN THE STUDIES ARE CONDUCTED
WELL, AND YOU KNOW WHAT MAKES
FOR A FRUITFUL RELATIONSHIP THAT
IS, YOU KNOW HOPEFULLY
BENEFICIAL TO THE PEOPLE WHO
VOLUNTEERED IN THESE STUDIES.
THERE I GO, THE PEOPLE WHO ARE
INVOLVE IN THESE STADS AND THEIR
INVOLVEMENT.
>> GREAT.
THANK YOU WINSTON.
TRAIZY.
>> I JUST WANT TO BRICK IT BACK
TO THE QUESTION THAT WAS
ORIGINALLY ASKED IS IT'S REALLY
HARD AS I PATIENT ADVOCATE TO
PRIORITIZE THIS LIST AND HAVING
LOOKED BACK ON OUR OWN VAGUS
NERVE STIMULATOR AND OUR OWN
SPECIALIZED EQUIPMENT AND
JOURNEY AND TRIALS IT'S BEEN A
STEAMY HOT MESS BUT THERE ARE
THINGS THAT CAN BE DONE RIGHT
NOW, RIGHT?
SO MODIFICATIONS TO MAKE MORE
INFORMED CONSENT MORE PATIENT
FAMILY WOULD BE GREAT.
BRING IN AND TWEAKING THE
EXISTING SYSTEM, COMING UP WITH
A ROOP MAP AND WE WRITE DOWN
WHAT'S HAPPENING IN THIS MEETING
SOME OF THIS IS LOW HANGING
FRUIT, LIKE LIKE HOW HARD IS THE
STUDY TO CONNECT THE PATIENTS
TOGETHER SO THEY CAN FORM A
SUPPORT SYSTEM FOR EACH OTHER
AND OFFERING OTHER PSYCHOLOGICAL
SUPPORT AND IMAGINE WHAT SORT
OF--WE'RE LIVING TRAUMATIZED
LIVES SO SOMETHING--ANYTHING
BEYOND CONNECTING THE PATIENTS,
YOU KNOW IS HARD AND WHEN YOU
THINK ABOUT IT, IT'S, YOU KNOW
ALL RIGHT, SO YOU'RE A NAWR O
SURGEON, WHO DO YOU WANT TO LNCH
FROM, WHO DO YOU WANT TO HEAR
FROM, WHO YOU WANT TO HEAR FROM
ANOTHER NEUROSURGEON WHO'S BEEN
THERE AND DONE THAT, PATIENTS IN
ARE IN THE SAME BOAT SO WHEN YOU
APPROACH THINGS CAN YOU THINK
ABOUT PATIENT WHO IS HAVE BEEN
THERE AND DONE THAT I REMEMBER
WHEN WE WENT IN THE VNS TRIAL
AND THEY WERE LIKE, YEAH, SHE
WILL HAVE TO HAVE HER BATTERY
REPLACE, IT DIDN'T TOWN ON ME
FOLLOW A FEW YEARS LATE BUT SHE
HAS TO HAVE SURGERY TO EVERY 4
TO 5 YEARS TO REPLACE THE
BATTERY AND THE BATTERY CHANGES
AND NOW SHE HAS TONS OF SCAR
TISSUE IN THE AREA, OH MY GOD IT
THERE'S AN EMERGENCY, THE
BATTERY HAS RIPPED THROUGH THE
SURFACE OF THE SKIN AND NOW WHAT
WHAT DO WE DO AND THEN, YOU KNOW
THERE HAVE BEEN ISSUES WITH,A
PROVAL AND SO THE DEVICE WAS
APPROVED FOR SEIZURES BUT MY
DAUGHTER HAS A DIAGNOSIS OF LGS
SO NOW THE COMPANY WON'T TALK TO
US ANYMORE, I SAID SHE HAS IT
FOR FOCUS SEIZURES WE DON'T HAVE
AN INDICATION OF LGS, LGS MEANS
HAVE YOU SEIZURES AND SOME OTHER
STUFF, YOU KNOW SO, I THINK
IMAGINING HOW TO--WHAT TO DO
WHEN THEY'RE IN-CARE IS HARD AND
MAYBE THAT'S ANOTHER STRONG
CONVERSATION BUT YOU COULD
CERTAINLY COME UP WITH A
TRANSITION PLAN NOW FOR HOW ARE
WE GOING TO START THINK BEING
THIS AND INCLUDING PATIENTS IN
THE CONVERSATION SO YOU COULD DO
IT IN THE BEST WAY POSSIBLE.
>> GREAT.
SO I HAVE THE UNENVIABLE TASK TO
TRY TO SUMMARIZE WHAT WE'VE BEEN
TALKING ABOUT FOR THE LAST 2
HOURS BEFORE WE MOVE ON TO A
BREAK AND I THINK TRACEY JUST
HELP MEDE.
SHE JUST DID SOME OF IT, I DO
THINK WHAT'S MINIMUM WE SHOULD
PROVIDE WAS ACTUALLY IN SOME
RESPECTS SET UP IN THE BEGINNING
OF THE DAY AND R ITERATED BY
ISHAN AND OTHERS AND THAT IS
THERE NEEDS TO BE A PLAN AND
PRETTY ROBUST INFORMED CONSENT.
I ALSO HEARD VERY CLEARLY THAT,
THERE NEEDS TO BE A PLAN THAT
INCLUDES HOW PEOPLE WILL GET
BATTERIES CHANGED OR THE KINDS
OF MAINTENANCE THEY WOULD BE
HURT IF THEY DIDN'T GET AND THAT
SEEMS LIKE A MINIMUM.
A GOOD QUESTION OF WHEN DO WE GO
ABOVE THE MINIMUM.
I HEARD A LOT OF PEOPLE SAY THIS
WHOLE SPACE IS A SPACE IN WHICH
WE GO ABOVE THE MINIMUM OF WHAT
WE'RE NORMALLY--WHAT WE NORMALLY
OWE TO PEOPLE BASED ON THE
LANGUAGE THAT WINSTON JUST
SUGGESTED IN ANY CLINICAL TRIAL.
SO IN ANY CLINICAL TRIAL, WE OWE
PEOPLE SOME OF WHAT I JUST SAID,
AND WE ALSO OWE THEM LOTS OF
RESPECT.
WE OWE THEM, YOU KNOW LISTENING
TO THEIR VOICES, ET CETERA, BUT
IN THIS SPACE, BECAUSE THE MORAL
ENTANGLEMENTS ARE DIFFERENT AND
THE DEPENDENCEOT DEVICE IS A
DIFFERENT KIND OF DEPENDENCE
THAN SOMEONE MIGHT HAVE IF THEY
WERE DEPENDENT ON A DRUG, WE OWE
THEM MORE.
SO WHAT MORE DO WE OWE THEM IS
STILL I THINK AN OPEN QUESTION.
I HEARD ALSO A NUMBER OF THINGS
I THINK ARE REALLY IMPORTANT
THAT WE SHOULD CONTINUE TO TALK
ABOUT.
ONE OF THEM WAS IN DISCUSSIONS
AND IN A LOT OF THE Q&A COMMENTS
AND THAT IS WHEN IS A TRIAL
REALLY OVER?
SOMEBODY SAID THAT YESTERDAY,
YOU KNOW TRIALS NEVER REALLY
OVER IN A CERTAIN WAY.
SO THE SORT OF ARBITRARINESS OF
WHEN A TRIAL IS OVER IS
SOMETHING THAT IS WORTH TALKING
ABOUT.
WHETHER OR NOT THE TRIALS IN
THIS SPACE SHOULD BE THOUGHT OF
AS DIFFERENT IN TERMS OF THEIR
LENGTH IS SOMETHING THAT MAYBE
WE COULD THINK ABOUT MORE
CAREFULLY.
ANOTHER 1 IS WHAT EXACTLY IS
BENEFIT.
I MEAN THIS AM CANS UP ON ALL
THE TIME AND QUIET IS, WHAT DOES
IT MEAN IN THIS CONTEXT BUT ALSO
WHO GETS TO DECIDE WHAT'S
BENEFIT IN THAT SEEMS LIKE
SOMETHING THAT HAS BEEN COMING
UP OVER AND OVER AGAIN.
AND THEN THERE WERE LOTS OF
OTHER RELATED AND I THINK
IMPORTANT THINGS TO THINK ABOUT
IN THE CONTEXT OF WHAT WE OWE
PEOPLE, THAT MAY OR MAY NOT BE
DIRECTLY RELATED TO WHAT WE OWE
THEM WHEN THE TRIAL IS
CONTINUING OR OVER OR SOMETHING
LIKE THAT.
FOR EXAMPLE, THE QUESTIONS OF
COMPENSATION.
BUT ALSO THE IDEA THAT
PARTICIPANTS SHOULD BE INVOLVED
FROM THE VERY, VERY BEGINNING IN
DESIGNING STUDIES IN TALKING
ABOUT WHAT'S IMPORTANT IN THE
DESIGN OF THE STUDY AND IN
THINKING ABOUT HOW THEY FIT INTO
A STUDY THAT'S BEING PUT
TOGETHER.
AND I HEARD 1 OTHER THING FROM
DR. MARLAER THAT I WANT --MARLET
I WANT TO PUT ON THE TABLE THAT
MAYBE THERE SHOULD BE CERTAIN
REQUIREMENTS IN THE DESIGN OF
TRIALS OF THIS NATURE IN TERMS
OF COMPATIBILITY IN TERMS OF
SAFE TO REMOVE, CERTAIN THINGS
THAT MIGHT, YOU KNOW MAYBE BE ON
THE FRONT END IN TERMS OF THESE
ARE THINGS THAT SHOULD BE
CONSIDERED WHEN WE'RE DESIGNING
TRIALS.
SO I JUST--I WOULD LOVE TO HEAR
SASKIA, IF YOU WANT TO ADD
ANYTHING TO THAT AND THEN TURN
IT OVER TO NINA TO GET US TO THE
BREAK.
>> IT WAS GREAT.
I WILL TURN IT TO NINA, AND THEN
RESTART US AFTER THE BREAK.
>> OKAY.
>> WONDERFUL, YES, OKAY, THANK
YOU ALL FOR THE REALLY RICH AND
THOUGHTFUL CONVERSATIONS TO BE
CONTINUED IN OUR LAST SESSION
WHICH WILL BEGIN AT 3:00 P.M.
EASTERN TIME SO WE WILL TAKE A
BREAK FOR THE NEXT 27 MINUTES OR
SO.
AND THEN WE WILL SEE EVERYBODY
AGAIN SHORTLY.
THANK YOU SO MUCH.
>>WE CAN BEGIN
WITH THE LAST SESSION FOR
TODAY'S PORTION OF THE WORKSHOP.
SO I HOPE EVERYBODY ENJOYED THE
BREAK, GOT A TIME TO STRETCH A
LITTLE BIT AND THIS LAST SESSION
IS I THINK, YOU KNOW AS WE
TALKED ABOUT EARLIER, BUILDS
UPON EVERYTHING WE'VE HEARD SO
FAR SO FIRST KNOWING WHAT THE
NEEDS, WHAT IS IN PLACE, AND
THIS MOST RECENT PANEL IS
DISCUSSING WHAT SHOULD BE IN
PLACE.
SO, WE WOULD LIKE TO SPEND A
LITTLE BIT OF TIME WITH THIS
DISCUSSION AND SESSION TO TALK A
LITTLE BIT MORE ABOUT THOSE
IDENTIFIED GAPS AND UNMET NEEDS
SO FOR THIS SESSION I WILL TURN
IT OVER TO DR. HANK GREELY, AND
DR. SASKIA HENDRIKs,.
>> STARTING WITH, IS ASKIA.
>> HEY, EVERYBODY.
I APOLOGIZE, I'M HAVING SOME
TROUBLE WITH MY CAMERA.
BUT I AM GOING TO PRESENT SOME
SLIDES.
>> THEY'RE STILL LOADING IN.
>> THERE THEY ARE MPLET.
>> SO WE'VE ATTEMPTED TO
SUMMARIZE SOME OF THE DISCUSSION
FROM THE LAST PANEL.
I THANK YOU ALL FOR WORKING ON
THIS WITH ME.
AND WE'VE ATTEMPTED TO SUMMARIZE
SOME OF THE DISCUSSION FROM
PANEL 3 IN AS FAR AS IN RELEVANT
FOR THE PANEL THAT WE'RE ABOUT
TO HEAD INTO.
SO I WANT TO START WITH SOME--I
WOULD SAY INITIAL REALITIES.
FIRST OF ALL, TO ACKNOWLEDGE
THRA THERE MAY NOT BE ANY
PERFECT SOLUTIONS IN A SENSE
THAT THERE MAY ALWAYS BE THINGS
THAT HAPPEN, SCENARIOS THAT
UNFOLD THAT WE HAVE NOT
PARTICIPATED AND PLANNED FOR.
IT'S IMPORTANT TO ACKNOWLEDGE
HERE AS WELL, THE
RESPONSIBILITIES THAT WE'RE
TALKING ABOUT MUST BE SHARED.
BUT ALSO TO ACKNOWLEDGE THAT
EACH OF THE PROFESSIONAL
STAKEHOLDERS INVOLVED HAS LIMITS
BUT RELATED TO THEIR MISSIONS
AND THEIR RESOURCES FINALLY, I
THINK IT'S IMPORTANT TO NOTE
HERE THAT BASED ON THIS ENTIRE
MEETING IT SOUNDS LIKE THERE WAS
MORE THAT WE MUST DO WHETHER IT
COMES TO POST TRIAL CARE THAN
WHAT'S CURRENTLY BEING DONE.
OKAY, SO HERE ARE SOME OF THE
THINGS WE HEARD THAT PEOPLE HAVE
ARGUED THAT WE SHOULD BE
PROVIDING FOR PARTICIPANTS AFTER
TRIALS AND IT SOUNDED LIKE THERE
WAS A COUPLE CONSENSUS ON THESE
POINTS, IF THERE WAS NOT, FEEL
FREE TO LET ME KNOW DURING THE
DITION CUSHION THAT FOLLOWS.
SO FIRST OF THIS IS A FAMILIAR
WITH, WE SHOULD PLAN FOR POST
TRIAL CARE AHEAD OF THE TRIAL.
SECOND, IT SOUNDS LIKE WE NEED
TO IMPROVE PROPER CONSENT WHEN
IT COMES TO POST TRIAL CARE AND
ALSO INCLUDES CLARIFYING FUTUREK
SESES TO CARE AND ASSOCIATED OUT
OF POCKET EXPENSES.
>> AND BECAUSE OF THE FEATURES
FOR THE RISKS INVOLVED, OF
IMPLANTING DEVICES, AND--AS
COMPARED TO MAYBE RESEARCH IN
GENERAL, IN WHICH SOME
RESPONSIBILITIES DO EXIST, THESE
TYPES OF TRANSFER REQUIRE MORE
THAN MAYBE AVERAGE TRIAL .
SO PEOPLE HAVE ARGUE THAD WE
NEED TO INSURE POST-TRIAL ACCESS
TO DEVICES AND DEVICES TO THE
BENEFITS.
AND ALL NECESSARY HARDWARE,
SOFTWAREND ASSOCIATED CARE.
FURTHER MORE, FOR THOSE PATIENTS
WHO DO NOT GET HALF THE TYPES OF
BENEFITS AND MAY NOT GET POST
TRIAL ACCESS NEED TO SUPPORT THE
CONVERSATION AS THEY'RE MOVING
OUT OF THE TRIAL.
WHICH CURRENTLY WE'VE HAD TO
SUPPORT TRANSPLANTATION, IN MOST
CASES IT'S ALREADY COVERED BY
PATIENTS INSURANCE, AND THERE'S
I THINK WE HAVEN'T HAD MUCH
DISCUSSION ABOUT WHETHER THIS
SHOULD ALSO BE COVERED BY THE
STAKEHOLDERS IF IT'S AN ELECT
IMPEDIMENTS EXPLANTATION.
WE HEARD THAT WE HAVE TO INVOLVE
PATIENT PARTICIPANTS FROM THE
TRAVEL SAME, NEED TO SEEK
SIGNIFY VERSITY IN OUR
PARTICIPANTS AND WE NEED TO
IMPROVE THE ABILITY OF RESEARCH
DATA FOR PARTICIPANTS AND
OTHERS.
THERE'S A COUPLE THINGS WE
SHOULD ALSO CONSIDER, THERE'S
PROBABLY MORE THAT WE'VE HEARD
MANY GREAT SUGGESTIONS THAT WE
WILL CAPTURE SO I APOLOGIZE IF
WE DIDN'T CAPTURE ALL OF THEM
BUT THINGS WE SHOULD CONSIDER
INCLUDE DESIGN OF TRIAL, USE
INTERCHANGEABLE HARDWARE
COMPONENTS IF POSSIBLE, DESIGN
DEVICES FOR SAFE AND EASY
REMOVAL AND INVOLVE CMS TO
CAPTURE METRICS THEY NEED TO
DECIDE ON COVERAGE WE ALSO
SHOULD CONSIDER MORE LONG-TERM
FOR LONG FOR SOME OF THESE
RESEARCH TRIALS.
OKAY, WITH THAT, 1 MORE SLIDE, I
HOPE CAN YOU SEE IT HERE WHICH
FORMULATES THE MAIN DISCUSSION
QUESTIONS FOR THIS FORUM: WHAT,
I GUESS I HAVE DONE A PROPOSAL
FOR NEEDS THAT AREN'T COVERED
AND SHOULD BE COVERED AND I
WOULD LIKE TO SEE THE BEST
SOLUTIONS, SO HOW DO WE BEST
ADDRESS THESE ITEMS THAT I JUST
HIGHLIGHTED?
SO WITH THAT, I WOULD LIKE TO
OPEN IT UP FOR DISCUSSION AND
INVITE ALL NUMBERS AND ALL
PANELISTS TO PARTICIPATE.
THIS REALLY--WE'VE SPECIFICALLY
INVITED A COUPLE OF PARTICIPANTS
TO MAKE SURE THAT
REPRESENTATIVES OF EACH OF THE
DIFFERENT STAKEHOLDER GROUPS
WILL BE AVAILABLE BUT WE'RE
HOPING ALL PANELISTS AND NEW
PANELISTS WILL PARTICIPATE IN
THIS DISCUSSION ABOUT SOLUTIONS.
>> AND WE HAVE ABOUT 75 MINUTES
TO SOLVE EVERYTHING.
SO.
ARE THE'S GO FOR IT.
HANDS?
>> I DON'T SEE HANDS BUT I WILL
SAY 1 THING.
I MEAN, I THINK THE BRAIN
INITIATIVE, THIS JUST COVERS
PART OF IT BUT NIH IN GENERAL
HAS A LOT OF POWER HERE IN TERMS
OF OBVIOUSLY PAYMENT FOR, YOU
KNOW KIND OF THE FUNDING THAT
GOES INTO MANY OF THESE TRIALS
AND THESE STUDIES AND THE
COMPANIES THAT THE DEVICE
MANUFACTURES WILL GENERALLY
DONATE THE DEVICES BUT I THINK,
NIH COULD ESTABLISH SOME
RESTRICTIONS ABOUT RULEGIVING
THIS GRANT SOMETHING BOTH MENTAL
DEVICE MANUFACTURES IF YOU ARE
GOING TO BE INVOLVED, YOU ARE
BENEFITING IN SOME WAYS FROM THE
DATA THAT'S BEING COLLECTED AND
THEN HOPEFULLY GETTING AT LEAST
SOME COMMITMENT FROM THE
COMPANIES THAT THE HARDWARE AND
BATTERIES, ET CETERA WILL BE
AVAILABLE AT LEAST FOR A CERTAIN
AMOUNT OF TIME.
I THINK THAT WOULD BE, YOU KNOW
THAT THAT WOULD NOT SOLVE THE
ENTIRE PROBLEM BUT IT WOULD AT
LEAST PROVIDE ACCESS AND
MAINTENANCE AVAILABILITY OF THE
HARDWARE AT LEAST FOR SOME
PERIOD OF TIME.
>> I'M SORRY DID YOU--DID YOU
CALL ON SOMEBODY TO SPEAK?
>> YES, I ASKED IF JOHN WOULD
LIKE TO RESPOND?
>> SORRY, ZOOM WAS GIVING ME THE
SPINNING BEACH BALL OF DEATH FOR
A FEW MINUTES IT HAD ME GOING.
YEAH, THAT'S A GREAT POINT.
WHAT WE WOULD LIKE TO DO THEN,
THE ISSUE IS, WHICH IS EXPLAINED
TO ME BY PEOPLE WAY ABOVE MY PAY
GRADE IS THAT NIH IS NOT ABLE TO
ENFORCE CERTAIN CONDITIONS
BEYOND THE ACTUAL PROJECT
PERIOD.
SO, I'M NOT LOOKING AT THAT AS
SO MUCH OF AN OBSTACLE AS A
CHALLENGE, RIGHT?
SO RIGHT NOW, WE ARE WORKING ON
A VARIOUS WORK AROUNDS.
I MEAN THE REALITY IS, THERE ARE
SOME THINGS WHERE I THINK
THERE'S WIGGLE ROOM AND OTHER
THINGS WHERE WE JUST DON'T HAVE
IT BUT THAT'S NOT TO SAY WE'RE
NOT LOOKING FOR CERTAIN WORK
AROUNDS.
I MEAN THE HUGE PROBLEM IS, WHEN
A COMPANY GOES OUT OF BUSINESS,
RIGHT?
AND THERE'S NO PARTS, NOBODY TO
UPDATE, NOBODY TO MAINTAIN,
LIMITED LIABILITY, OR ANOTHER
TRICKY SITUATION WHERE A COMPANY
DECIDES, WELL THEY'RE NOT GOING
TO SUPPORT THE INSTRUMENT
ANYMORE OR THEY WILL GET OUT OF
THE SPACE ALTOGETHER AND THIS
LEAVESERB IN A LURCH AND THIS IS
THE SITUATION WHERE I THINK
ANYTIME WE'RE DEALING WITH ANY
ENTITY, IT'S A KNOWN RISK,
RIGHT?
AND THE ISSUE IS, IF WE
ELIMINATE ALL RISK WE DON'T DO
ANY OF THESE EXPERIMENTS SO THE
CHALLENGE FOR US, ALL OF US, ALL
STAKEHOLDER SYSTEM TO ASSESS THE
RISK OF FINDING WAYS TO MITIGATE
IT AS MUCH AS POSSIBLE.
WE CAN GO ON, AND I'M HAPPY TO
DISCUSS SPECIFICS YOU BUT THE
REALITY IS THAT WE HAVE TO GO ON
AND IN SOME CASES OUR HANDS ARE
NOT JUST TIED BUT THEY ARE HAND
CUFFED BUT WE ARE LOOKING FOR
WORK AROUNDS IN THIS SPACE AND I
THINK IT'S UNCUMBENT ON ALL OF
US TO LOOK AT WORK AROUNDS, FROM
OUR POINT OF VIEW, COMPANIES,
INSURERS, CMS, FDA, EVERYBODY
MPLET THE REASON WHY WE'RE
HAVING TO WORKSHOP IS BECAUSE WE
ARE VERY FRUSTRATED BY THE
CURRENT STATE OF AFFAIRS.
>> DR. DIXON-SALAZAR?
>> I AGREE WITH JOHN.
I THINK WE RUN INTO TROUBLE IF
THE DEVICE DOESN'T GET FDA
APPROVED RIGHT AND WE HAVE QUITE
A FEW RESPONDERS IN OUR
COMMUNITY TO CERTAIN
THERAPEUTICS THAT GOT
DISCONTINUED AND THEN THAT'S
WHERE THEY REALLY GET IN
TROUBLE.
BUT THERE'S ALSO THIS
TRANSITION, SO LET'S SAY THE
DEVICE DOES GET APPROVED AND NOW
YOU HAVE TO TRANSITION OVER FROM
THE TRIAL TO IT BEING COVERED,
THAT WHOLE PROCESS IS DOABLE AND
REASONABLE, BUT IT'S REALLY SORT
OF THROWN AT THE HANDS OF
PATIENTS, AT LEAST IT HAS BEEN
IN OUR INSTANCES AND IT REQUIRES
A VERY SAVVY PATIENT TO BE ABLE
TO NAVIGATE THAT, EXITING THE
TRIAL, ENTERING THE INSURANCE
WORLD MAZE SO ANY HELP THAT CAN
BE DONE THERE I THINK WOULD BE
REALLY CRITICAL AND THEN I WOULD
JUST SAY, TOO, THAT YOU KNOW
THAT NOW WE'RE ENTERING A PHASE
IN LGS WHERE THE DEVICES DBS HAS
BEEN APPROVE INDEED EPILEMESY,
RIGHT?
AND RNS HAS BEEN APPROVE INDEED
ELLEPSY O OUR FAMILIES ARE
RUSHING TO GET THEM OFF LABEL IF
THEY CAN WHICH REQUIRES A VERY
SAVVY PATIENT AND DISKRIM FLAITS
AGAINST MOST OF OUR FAMILIES,
BUT ALSO NOW THERE'S TRIALS
BEING STARTED AND SO THAT--THAT
SEEMS TO BE SORT OF AN EASIER
ASK BECAUSE THE TRIALS NOW IS
ACTUALLY, THERE'S A MARKET FOR
AN APPROVED--FOR IMPROVED DEVICE
ALREADY SO I DON'T KNOW YOU NEED
TO SPEND AS MUCH TIME IN THAT
AREA BUT THOSE FIRST 2 AREAS
COULD REALLY HELP AND I THINK
PATIENTS EXPECTATIONS ARE
REASONABLE.
I DON'T EXPECT YOU LIKE ALL
RIGHT, SO IF MY KID HAD A HUGE
SEIZURE REDUCTION, I DON'T
EXPECT YOU TO MAINTAIN IT FOR 30
YEARS IF THE COMPANY HAS GONE
OUT OF BUSINESS, BUT, I MEAN,
WHAT AGREEMENT CAN WE COME TO
WHERE ALL OF A SUDDEN 1 DAY I
JUST DON'T HAVE ACCESS ANYMORE.
AND I WAS BT NECESSARILY EVEN
PREPARED FOR IT WHEN IT
HAPPENED.
>> WOB OF THE THINGS WE TALKED
ABOUT IN A LITTLE BIT OF THE
PAST HALF HOUR IS PART OF WHAT
SHE SAID IS THAT MAYBE TRIAL
PARTICIPANTS SHOULD HAVE SOME
SPECIAL STATUS, SOME SPECIAL
PLACE IN LINE WHEN SOMETHING
ACTUALLY BECOMES APPROVED THE
SPONSORS SHOULD HAVE AN
ABNORMALITIES LIGATION TO REACH
OUT TO THEM FIRST AND EXPLAIN TO
THEM AND MAKE IT EASY FOR THEM
TO TRANSITION THAN TO THE
APPROVED OR PERHAPS EVEN IN SOME
CASES IF THERE'S A SECOND TRIAL
WITH THE NEW AND IMPROVED DEVICE
FOR WHICH THEY'RE NOT CONTRA
INDICATE THAD THEY SHOULD HAVE A
SPECIAL STATUS WITH RESPECT TO
BEING INFORMED ABOUT AND
POTENTIALLY ELIGIBLE FOR.
SO I THINK THAT'S A GOOD THING
TO BE THINKING ABOUT.
THEY PUT THREZ BODIES AND BRAINS
ON THE LINE THEY DESERVE, THEY
SHOULD BE ABLE TO CUT IN LINE.
I THINK.
>> MARK DID YOU WANT TO RESPOND.
>> AND THEN--
>> I DID, A COUPLE COMMENTS,
THERE ARE 2 SCENARIOS FOR
COMPANIES AND 1 IS THAT THE
COMPANY IS INTERESTED IN
SUPPORTING A TRIAL BECAUSE IN
GENERAL, THEY WANT SOME EARLY
EXPERIENCE TO UNDERSTAND WHETHER
THIS IS SOMETHING THEY WANT TO
INVEST A HUGE AMOUNT OF MONEY
INTO EXPLORING TOWARDS AN
INDICATION FOR USE.
THAT'S 1 SITUATION.
THE OTHER SITUATION AND I THINK
MANY DEVICE MANUFACTURES HAVE
RUN INTO THIS, IS THAT HAVE YOU
A PLATFORM TECHNOLOGY AND THERE
ARE A NUMBER OF RESEARCHERS OUT
THERE WHO WANT TO USE IT FOR
THEIR OWN PURPOSES, THAT
MAY--THE COMPANY MAY NOT THINK
THAL WOULD MAKE SENSE FOR THE
COMPANY TO PURSUE.
IT ARE MAY BE TOTALLY OUTSIDE OF
THE DISEASE STATE.
SO IT CERTAINLY HAS BEEN THE
EXPERIENCE WE HAVE AT NEUROPACE,
I BELIEVE IT'S ALSO BEEN THE
EXPERIENCE WITH MEDTRONNIC THAT
THERE ARE REQUESTS, MANY OF
THEM, PLEASE LET ME USE THIS
DEVICE FOR THIS CONDITION.
IF WE ARE REQUIRING TO THE
COMPANY PROVIDE SOME TYPE OF OR
HAVE SOME TYPE OF FINANCIAL
OBLIGATION TO PATIENTS FOR THOSE
STUDIES, ALREADY THERE'S A
DISINSENT TESTIFY SUPPORT THAT
BECAUSE IT REQUIRES TIME.
IT REQUIRES TIME FROM PEOPLE
WHOSE JOBS ARE FOCUSED
ELSEWHERE.
BUT, I THINK COMPANIES ARE MORE
OR LESS WILLING TO HELP SOMEBODY
PURSUE THEIR RESEARCH BUT IF
THERE IS AN ADDITION A FINANCIAL
OBLIGATION, THAT WILL MAKE IT
VERY HARD TO SUPPORT A LOT OF
THIS STUFF THAT IS SECONDARY TO
WHAT THE COMPANIES MISSION IS.
>> COULD I JUST ADD TO WHAT
MARTY JUST SAID ON THE INDUSTRY
SIDE AND I HAVE A COUPLE OTHER
COMMENTS.
YOU KNOW 1 THING WE COULD
LOAMACY BEINGA FROM AN
INTERAGENCY STANDPOINT IS THAT
ORPHAN DRUGS HAVE TAX INCENTIVES
AND FINANCIAL INCENTIVES FOR
COMPANIES AND PRIVATE INDUSTRIES
TO PURSUE, WE DON'T HAVE THAT IN
ORPHAN DEVICES SO WE COULD START
TO MIMIC WHAT WE HAVE IN ORPHAN
DRUGS WITH ORPHAN POPULATIONS
FOR DEVICES AND THAT MIGHT BE A
POTENTIAL INDUSTRY INCENTIVE TO
PURSUE SOME OF THE SMALLER
MARKETS.
ALSO THERE'S IT PROTECTION THAT
COMES ALONG WITH AN ORPHAN DRUG
I BELIEVE IT'S 7 YEARS ONCE IT'S
APPROVED BUT COULD ALSO BE AN
INCENTIVE FOR INDUSTRY TO GO
AFTER YOU KNOW SMALLER
POPULATIONS LIKE SPINAL CORD
INJURIES.
BUT I ALMS WANTED TO ADD A
COUPLE OTHER COMMENTS TO THE
CONVERSATION, WE'VE TAKED A LOT
AROUND INVOLVING PEOPLE WITH
LIVED EXPERIENCE EARLY IN ON THE
PROCESS AND I THINK NIH HAS A
REALLY UNIQUE OPPORTUNITY AS PAY
FUNDER TO BE ABLE TO PUT
GUIDANCE OUT THERE FOR THE
CLINICAL TRIALS DESIGN.
THERE ARE FUNDING AGENCIES LIKE
THE D.O.D. CDMRP WHICH DOES
REQUIRE IN SOME OF THEIR FUNDING
MECHANISMS, TO HAVE PEOPLE WITH
LIVED EXPERIENCE INVOLVED IN THE
RESEARCH, SO I THINK IT'S--IT'S
NOT A HUGE ASK TO HAVE NIH START
TO TAKE THIS STANCE AS WELL TO
REALLY START TO EMBED SOME
UNDERSTANDING OF THE PATIENT
EXPERIENCE AS THEY'RE GOING
THROUGH THE DESIGN OF TRIAL.
AND ALSO WHILE I'M ON THE TOPIC
OF PROTOCOL DESIGN, WE CAN COME
UP WITH A ROADMAP OF WHAT THAT
NEEDS TO LOOK LIKE.
TRACEY MENTIONED THAT EARLIER
BUT FIRST, LOOKING AT PLABTED
DEVICES TO HAVE A PLAN FOR WHAT
THOSE DEVICES MIGHT BE AND TR
TRACKING, I'M NOT COMPLETELY
CLEAR ON THIS BUT I BELIEVE THE
EUROPEAN MODEL HAS SOMETHING
SIMILAR TO THIS, THAT IF YOU'RE
GOING TO HAVE IMPLANTED DEVICES
FROM A SAFETY PERSPECTIVE ALSO
WE TALKED ABOUT PATIENT JOURNEY
MAPPING.
THIS IS WHERE A LOT OF THE
BURDEN CAN BE FOUND.
I CAN'T TELL YOU HO YOU MANY
SPINAL CORD INJURY TRIALS THEY
HAVE AND HOW DIFFICULT IT IS TO
TRANSPORT SOMEONE WITH A FINAL
CORD INJURY WITH A POWER CHAIR
FROM 1 PLACE TO ANOTHER AND IT'S
A HUGE FINANCIAL BURDEN FOR
PEOPLE TO PARTICIPATE BUT
TYPICALLY THAT'S NOT FOUND UNTIL
YOU MAP OUT THE PATIENT JOURNEY
SO THAT'S ANOTHER STANDARD WE
CAN PUT IN PLACE LOOKING AT THE
FUNDING AND DESIGN OF TRIALS AND
FINALLY MY LAST POINT IS, 1 OF
THE POINTS YOU BROUGHT UP FOR
THE DISCUSSION IS LONG-TERM
FOLLOW UP AND AGAIN, I WANT TO
BRING THIS UP IS THAT I THINK
WE'RE MISSING AN OPPORTUNITY TO
COLLECT LONG-TERM DATA USE OF
IMPLANTED DEVICES WHERE WE CAN
LEARN A LOT ABOUT THESE EARLY
STAGE DEVICES AND IF, YOU KNOW
IF WE HAVE THESE FOLLOW ON
STUDIES, THAT PARTICIPANTS ARE
REQUIRED TO PARTICIPATE IN THAT
AND SHARE THEIR DATA.
SO I THINK THAT'S ANOTHER
POSSIBILITY WHERE WE ARE STILL
IN KIND OF THE EARLY STAGES OF
NEUROMODDULATION AND A LOT OF
THESE BRAIN TECHNOLOGIES THAT WE
CAN LEARN A LOT ALONG THE WAY IF
WE START ATRACKING THEM.
THANK YOU.
>> THOSE ARE GREAT SUGGESTIONS.
HANK DID YOU WANT TO COMMENT?
>> I'M NOT SURE I UNDERSTOOD IT
FULLY BUT THE IDEA OF
PARTICIPANTS BEING REQUIRED TO
CONTINUE IN LONG-TERM STUDIES IS
PROBLEMATIC AND THE COMMON RULE
GUARANTEES ANY RESEARCH
PARTICIPANT THE RIGHT TO
WITHDRAW.
>> EXACTLY.
SIEM SORRY, DON'T MISS
UNDERSTOOD ME THEY HAVE THE
OPTION FOR A LONG-TERM STUDY, SO
THEY WOULD SIGN UP FOR IT, SO IF
THERE IS AN OBLIGATION THAT OH,
OKAY, WE WILL SUPPORT THIS
DEVICE FOR THE NEXT 5 YEARS
AFTER THE STUDY, THERE SHOULD BE
AN OBLIGATIONOT PARTICIPANTS
PART THAT THEY NEED TO BE, YOU
KNOW IN ON THE PARTICIPATION AND
SHARE THEIR DATA AS WELL.
I HOPE THAT CLARIFIED.
>> YES, THANKS FOR CLARIFYING
THAT.
>> BRANDY ELLIS?
>> URGTER TO THAT, IT MATCHES UP
WITH MY SUGGESTION WHICH IS AT
THE END OF THE TRIAL, THERE IS
NO, LIKE THE CONSENT TO START
BUT AT THE END THERE'S NO LIKE,
GOODBYE.
LIKE I DON'T RECEIVE PAPERWORK
THAT SAYS, HERE'S WHAT YOU DID,
HERE'S WHAT YOU HAVE, WHATEVER,
AND I DO THINK THAT THAT END OF
TRIAL CONTACT IS AN OPPORTUNITY
TO SAY, ALL RIGHT, HERE'S
INFORMATION THAT YOU MIGHT NEED
BUT THAT'S ALSO TO THE PREVIOUS
POINT, THAT'S AN OPPORTUNITY TO
GO AND HERE'S A CONSENT FOR
GENERIC LONG-TERM FOLLOW UP
STUDY.
AND YOU WILL CONTINUE TO
PARTICIPATE IN THIS NEW
LONG-TERM FOLLOW UP THAT YOU'RE
CONSENTED INTO, THEN THESE ARE
THE BENEFITS THAT YOU GET IN
THAT IF YOU'RE DEVICE, YOU KNOW
IS DISCONTINUED, YOU KNOW, WE
WILL KEEP YOU ABREAST OF
ALTERNATIVES, SO, RIGHT NOW, AT
THE END OF A TRIAL IS SORT OF
LIKE, BYE.
SO POST TRIAL RESPONSIBILITIES,
IF WE'RE GOING TO OUTLINE THEM,
THAT'S GOING TO NECESSITATE SOME
END OF TRIAL DOCUMENTATION AND
THAT IS AN OPPORTUNITY TO
ACTIVELY TRANSITION FROM
PATIENTS EXPECTATIONS INSIDE THE
TRIAL TO EXPECTATIONS OUTSIDE
THE TRIAL AND IT MAKES IT VERY
CLEAR WHO IS RESPONSIBLE FOR
WHAT, WHEN, BECAUSE YES, I WOULD
GLAD HE CONTINUE TO DO FOLLOW
UPS IF IN EXCHANGE FOR THAT, I
WAS GUARANTEED THAT I WASN'T
GOING TO HAVE TO FRONT A HUNDRED
THOUSAND DOLLARS SERGEANTRY ON
MY OWN UPFRONT, YOU KNOW IN CASE
OF AN EMERGENCY.
SO, OR EVEN JUST TO PROVIDE THE
DATA OF, YOU KNOW NOBODY KNOWS
IF 50 YEARS FROM NOW, IT'S LIKE,
OH IT HAD A 50 YEAR LIFE SPAN.
SO HAVING A WAY TO DOCUMENT AND
TO TRANSITION I THINK IS A
VIABLE SOLUTION WHERE EVERYBODY
KNOWS WHERE EVERYBODY STANDS,
AND IFOU WANT OUT, YOU'RE OUT
AND YOU DON'T HAVE TO PROVIDE
FOLLOW UP CARE AND YOU CAN
DECIDE THAT YOU KNOW, YOU ARE
EITHER GOING TO LEAVE THE DEVICE
IN AND YOU KNOW WHAT HAPPENS OR
EXPLANTED, LIKE THOSE THINGS CAN
BE OUTLINED AND PLANNING FOR
THAT DOCUMENT AND PLANNING FOR
WHAT IT'S GOT TO ENCOMPASS HELPS
EVERYBODY THINK ABOUT IT AT THE
BEGINNING.
>> SO I'M CURIOUS WHAT PEOPLE
THINK ABOUT THIS, I MEAN 1 OF
THE CREATIVE SOLUTIONS FOR
[INDISCERNIBLE] WILL BE ANOTHER
TRIAL THAT PARTICIPANTS COULD
ENROLL IN, AND MAYBE WE COULD
SPEBD TIME ON THAT POTENTIAL
SOLUTION, FROM MY PERSPECTIVE 1
OF THE CHALLENGE SYSTEM THAT WE
WANT TO HAVE A POST TRIAL PLAN
AHEAD OF THE START OF THE FIRST
TRIAL, SO TO SAY, RIGHT?
THAT'S 1 OF OUR PREMISES AND
THEN I THINK 1 OF THE CHALLENGES
IS THAT THOSE TYPES OF FOLLOW UP
STUDIES, AT LEAST THE CURRENT
1S, THEY'RE USUALLY NOT DECIDED
UPON, UNTIL MAYBE JUST BEFORE,
LIKE THE END OF THE STUDY, SO I
WONDER, HUGH CAN WE MAKE THIS
WORK BETTER AS THE LONG-TERM
SOLUTION.
IN MY SENSE, IT REALLY--I WAS
INTENDING IT TO BE THE SAME AS
THE REGISTRY I DISCUSSED IS IT
IS ANOTHER--IT DOESN'T HAVE TO
BE A TRIAL.
IT CAN BE A SORT OF WHETHER
THAT'S THE REGISTRY THAT YOU'RE
PARTICIPATING IN THIS ORDER TO
HAVE YOUR DATA THERE, BUT ALSO,
YOU KNOW TO IDENTIFY THAT YOU
ARE A PARTICIPANT AND ARE
AVAILABLE FOR BENEFITS OF THAT,
SO THEY OVERLAP IN THAT.
SO IT'S A WAY FOR IF A TRIAL
TEAM CAN'T SUPPORT IT ANYMORE, I
AM VERY FORTUNATE TO MY TRIAL
TEAM IS STILL DOING THIS AND IS
INTERACTING WITH ME EVEN POST
TRIAL BUT FOR THOSE TRIALS THAT
ENDED IN THE TRIAL TEAM AND NO
LONGER AVAILABLE, YOU KNOW THAT
IT DOESN'T MATTER WHO IT IS, IT
COULD BE THE TRIAL TEAM,
MAINTAINS FOLLOW UP, IT COULD BE
THAT NO, OTHER ENTITY, THE
REGISTRY MAINTAINS FOLLOW UP,
BUT, THAT THE IDEA OF REGARDLESS
OF CIRCUMSTANCES, THERE IS
SOMEBODY WHO CAN, YOU KNOW
PROVIDE THE SUPPORT AND
ASSISTANCE IN TRANSITION, AND IS
IT A CLEARINGHOUSE FOR THE DATA.
>> SO I THINK THE LONG-TERM SIDE
OF THIS IS VERY INTERESTING BUT
I DON'T WANT US TO LOSE A VERY
CONCRETE SHORT-TERM SUGGESTION
YOU MADE WHICH WAS AND THAT
HAPPEN BUT SORT OF BY THE
DISCUSSION WITH THE PARTICIPANT
OKAY THE TRIALS OVER HERE'S HOW
THINGS STAND AND HOW THEY'LL
LOOK IN THE FUTURE.
THAT SEEMS TO ME AN INTERESTING
A VERY POSSIBLE POSSIBILITY.
I LIKE THE IDEA.
I SEE SOME HANDS UP, DO SOME OF
THE HANDS RESPHOND THIS
PARTICULAR POINT OR I DO, I HAVE
A COUPLE COMMENTS.
>> TO JENNIFER'S POINT, THE
PARALLEL OF ORPHAN DRUG SYSTEM
VERY INTERESTING.
I KNOW MY INSTITUTION AN ORPHAN
DRUG WAS USED AND IT BECAME
VERY, VERY SUCCESSFUL, I MEAN
VERY SUCCESSFUL AND MADE MONEYY
FOR THE INSTITUTION AND THE
COMPANY, OF COURSE, PATIENT'S
BENEFITED OUTSIDE OF THE STUDY
BECAUSE IT WAS APPROVED AND USED
TO TREAT IN STANDARD OF CARE AND
SO RELATED TO THAT, WHAT TRULY
IS THE MISSION OF THE DRUG
COMPANY AND THE DEVICE COMPANY
IS THE MISSION TO BE BEHOLDEN TO
THEIR SHAREHOLDERS OR IS THERE
MISSION TO BE A CONDUIT TO
IMPROVE MEDICAL CARE, SO LET
ME--LET ME PULL THE SCENARIO TO
YOU COMPANY E IS VERY
SUCCESSFUL, HAS A DEVICE THAT'S
APPROVED.
AND MAKES MILLIONS OF DOLLARS IN
EASTERNINGS AND ALSO USES THE
DOUBLE IRISH TAXATION AGREEMENT
TO AVOID PAYING TAXES SO THEY'RE
VERY SUCCESSFUL, THEY'RE MAKING
MONEY.
IS PART OF THEIR MISSION THAT
THE FUNDS SHOULD FUNNEL BACK TO
PATIENTS TO SUPPORT THEM, I KNOW
THAT'S A SLIPPERY SLOPE?
AND I HAD 1 OTHER COMMENT, YOU
SAID SOMETHING ABOUT REGISTRY,
OH I KNOW WHAT DID WAS, REGISTRY
THIS DOES HAPPEN IN DRUG STUDIES
SO OFTEN TIMES FOR DRUG STUDIES
THERE'S LIKE THE PHASE 2, PHASE
3 AND WITH A SHIFT OVER TO
REGISTRIES BUT AGAIN, BRAND YOU
YOU BRING UP A GOOD POINT, THE
DATA IS NOT THERE FOR THE
PATIENTS TO ACCESS WHICH IS A
HUGE FEELING, YOU'RE PROVIDING
THE DATA AND YOU ALTRUISTICALLY
WANT TO PROVIDE THE DATA AND
WE'VE BEEN TALKING ABOUT LAWN
MOWER IS GOOD OR WHAT IS WORTH
AND REALLY, I THINK IT GOES EVEN
BEYOND THAT, I DON'T EVEN THINK
TECHNICALLY, IT'S YOURS ALREADY,
YOU SHOULD BE GETTING IT ALREADY
WHETHER IT'S THE CLINICAL
BENEFIT YOU'RE GETTING OR
COMPENSATION ACCESS TO YOUR DATA
AND WE HAVE ALL FAILED BY NOT
HAVING THAT BE THERE ALREADY.
OT POINTER OF THE REGISTRY, I
WANT TO POINT THAT THERE IS A
REGISTRY FOR THE FDA HAS IT'S
CALLED THAT DOES COLLECT
INFORMATION ABOUT DEVICES, IT'S
NOT ALL THE THINGS WE'RE
DISCUSSING IN THIS SESSION, I
JUST WANTED TO RAISE IT FOR YOUR
AWARENESS.
>> I'M A PHILOSOPHY, SO I'M NOT
IN THE MONEY WORLD AND I GET
WHAT EVERYBODY'S SAYING BUT THE
ACADEMIC INSTITUTIONS OR
HOSPITALS SHOULD BE PAYING MORE
BUT THE COMPANIES SHOULD BE
PAYING MORE AND IT SEEMS TO ME I
WOULD TAKE THEIR PRACTICE AS A
MODEL AND LET'S FIGURE OUT HOW
WE FUND THAT AND THEN I WAS
THINKING ABOUT SO THAT THE
DEFAULT IS IF YOU ARE GETTING
SOMETHING IMPLABTED IN YOUR
BRAIN AND SPINAL COLUMN, YOU
KNOW YOU'RE GOING TO BE FOLLOWED
AND YOU'RE GOING TO BE CARED FOR
IF YOU ARE GETTING BENEFIT FROM
THIS.
AND THERE ARE TRIALS, THERE ARE
INDIVIDUALS THAT SHOW
SIGNIFICANT CLINICAL BENEFIT AND
OVER ALL IT'S NOT THAT WAY AND I
GUESS SOME OF THE SOLUTION HAS
TO COME FROM YOU KNOW SO NOW
THERE'S THE LONG-TERM CARE PLAN
THAT'S PART OF THE NIH FUNDING
AND REVIEW BUT HAVING WITHIN
THAT PLAN, I THINK SOMETIMES THE
PLAN IS TO EXPLANT EVERYBODY AT
THE END OF THE STUDY AND OUR
PLAN IF SOMEBODY DOESN'T WANT TO
GET EXPLANTED AT THAT TIME
BECAUSE CLEARLY THEYAV WOULD
TO CONSENT TO TO GIVE THEM A
YEAR LONG WINDOW OR SOMETHING,
TO ME THAT'S NOT A SUFFICIENT
PLAN.
SO IF WE SO IF WE FIGURE OUT A
WAY FOR THESE TRIALS TO ALLOW
LONGER TERM, I DON'T KNOW WHAT
THEY'RE CALLED OR KEEP THE TRIAL
OPEN, I DON'T KNOW THE ONTOLOGY
OF TRIALS TO FIGURE SOMETHING
LIKE THAT OUT BUT SOMETHING LIKE
THAT AS THE DEFAULT OPTION SO
THEN HEARING ABOUT WHAT THEY
CAME BACK FROM NIH PACE AND SAID
WE WON'T DO THIS UNTIL WE FIGURE
OUT THIS BETTER LONG-TERM CARE
PLAN AND IT SOUNDS LIKE IT WAS
INCREDIBLE LOAMACYY DIFFICULT
AND SHE DIDN'T THINK IT WAS
NECESSARILY EQUITABLE AT THE END
BUT IF THERE ARE MODELS FOR THAT
AND THEN CAN YOU GO TO THE
ACADEM INDUSTRY AND THE PARTNER
AND SAY, LOOK, THIS IS WHAT THE,
IN IH RECOMMENDS AND THIS IS
WHAT HAS BEEN DONE IN THE PAST,
WE'RE CREATING A NORM THAT I
THINK PEOPLE CAN FOLLOW, I GET
THAT I'M NOT OFFERING DETAILS ON
EXACTLY WHAT THOSE PROPORTIONS
ARE.
>> I WOULD LIKE TO FROM THE
RESEARCHER STANDPOINT TO CLARIFY
SOMETHING, AND AS A CLINICIAN,
MY FIRST AND FOREMOST INTEREST
IS FOR THE PATIENTS WELL BEING,
HOWEVER, AS A RESEARCHER WEARING
THE OTHER HAT, THE HYPOTHESIS
THAT I SRO TO BE LAID OUT IN A
REASONABLE WAY THAT I WILL GET,
YOU KNOW DESIGN THAT'S GOING TO
WORK TO ANSWER THE QUESTION
WOULD BE UNIQUE ETHICAL
FRAMEWORK THAT SOMETIMES THE WAY
I HAVE TO ANSWER THOSE QUESTIONS
IS WORKING ALONG PATIENTS OR
PARTICIPANTS THAT ARE EXTREMELY
SICK AND HAVE FAILED MOST
TRIALS.
LIKE IN ANY NOVEL TREATMENT,
SOMETIMES YOU START YOU START AT
THE TIME.
>> THE GOAL FOR ME RINNING THESE
CLINICAL TRIALS OR THESE
STUDIES, IS 2 FOLD, 1 IS, YOU
KNOW I WANT TO I WANT TO SUNDAY
WHAT GOES ON IN THE BRAIN AND
WHAT HAPPENS IN DEPRESSION AND
WHAT HAPPENS IN THE
ELECTROPHYSIOLOGY OF THE CERTAIN
AREAS IN THE BRAIN AND THAT'S
SORT OF, YOU KNOW THE SCIENTIFIC
QUESTION, FOR WHICH NIH IS VERY
INTERESTED IN FINDING THAT.
ON THE OTHER HAND.
I WANT TO MAKE THIS TREATMENT
THEY THINK IT WORKS FOR A
MAJORITY OF PATIENTS BUT A LARGE
NUMBER OF PATIENTS, I WANT TO
MAKE IT AVAILABLE FOR PATIENTS
OUTSIDE OF A CLINICAL TRIAL.
THE GOAL FOR ME IS NOT TO RUN N
SMALL CLINICAL TRIALS IN WHICH I
HAVE 40 PATIENTS OVER 15 YEARS,
BECAUSE THAT WILL NEVER, YOU
KNOW ADD TOO HELPING THE
COMMUNITY, YOU KNOW OVERALL, THE
PATIENTS WITH TREATMENT
RESISTANT DEPRESSION OR WITH
LGS, IF EVERY PATIENT WITH LGS
NEEDED TO PARTICIPATE IN THE
TRIAL OR ANY PATIENT WITH LOCKED
IN SYNDROME, OR WHATEVER, THE
PARTICIPATION IN THE CLINICAL
TRIAL OF EACH OF THESE PATIENTS,
IS TECH HAD NIICALLY IMPOSSIBLE
SO WE HAVE TO THINK 2 WAYS, WHAT
CAN WE MAKE THE CLINICAL TRIAL
TO OPTIMIZE, YOU KNOW THE SIGNAL
DETECTION THAT WILL THEN HELP
MAYBE THE INDUSTRY, YOU KNOW
CMS, WHOEVER, STAKEHOLDER WILL
FUND A TRIAL AND THEN TAKE IT TO
THE GENERAL POPULATION BUT WE
CANNOT THINK INDEFINITELY
BECAUSE IT'S NOT PRACTICAL.
WE DON'T HAVE ENOUGH
PSYCHIATRISTS AND IMAGING
SCIENTISTS AND THE
ELECTROPHYSIOLOGISTS, ET CETERA
TO RUN A CLINICAL TRIAL IN EVERY
PATIENT THAT NEEDS THAT WOULD BE
ELIGIBLE, SO EEIVETTUALLY WE
HAVE TO MAKE IT, YOU KNOW
AVAILABLE FOR MORE PEOPLE.
WHAT IS THE ROLE OF EACH, YOU
KNOW AGENT WHETHER IT'S FDA,
NIH, CMS, [INDISCERNIBLE], AND
THEN TO MAKE IT AVAILABLE FOR
MORE PEOPLE THAT.'S WHAT I WOULD
LIKE TO UNDERSTAND BECAUSE
OTHERWISE, I FEEL LIKE, YOU
KNOW, INDEFINITELY, I COULD HAVE
A CAREER IMPLANTING 12 PATIENTS
A YEAR, 4 THE NEXT, YOU KNOW 40
YEARS OF MY LIFE, AND IT WILL
NOT MAKE A DIFFERENCE IN THE
GENERAL CHANGE OF POPULATION,
YOU KNOW AT LEAST THAT'S WHAT I
FEEL SOMETIMES.
I WANT TO IMPLANT MORE PEOPLE.
I WANT TO HELP MORE PEOPLE AND
FOR ME ALONE, YOU KNOW WORKING
IN AN IVORY TOWER IS NOT ENOUGH.
>> SO WE WOULD LIKE TO GO BACK
AND ASK RHONDA ABOUT SOMETHING
SHE BROUGHT UP IN PANEL 3, ABOUT
CONTINUUM OF CARE.
RHONDA ARE YOU THERE AND ABLE TO
SAY MORE ABOUT THAT?
IT SEEMS RELEVANT TO THE RECENT
DISCUSSION?
>> MAYBE NOT.
WELL WHILE THAT SIRCHGS IN,.
>> MAYBE I COULD--MARGT YOU HAD
A COMMENT IN THE Q&A THAT I
THINK MIGHT BE HELPFUL TO SHARE
WITH THE GROUP WHILE WE WAIT AND
SEE IF DR. BEIL CAN COME BACK
ON?
YEAH AND I WAS JUST WRITING A
FOLLOW UP TO THE COMMENT THAT
JOHN MADE TO MY FOLLOW UP.
I THINK THE CONCERN HERE IS THE
FIRST THING EVERYBODY NEEDS TO
KNOW IS WHAT IS THE RISK, HOW
LIKELY IS IT THAT A PATIENT IS
GOING TO HAVE AN ADVERSE EVENT
THAT WOULD REQUIRE SOME TYPE OF
MEDICAL INTERVENTION.
HOW FREQUENTLY IS A BATTERY
REPLACEMENT LIKELY TO--LIKELY TO
BE NEEDED, I MEAN, ALL OF THESE
THINGS, YOU KNOW HOW MANY
INDIVIDUALS WILL CHOOSE TO
CONTINUE TREATMENT.
IF YOU HAVE ALL OF THESE PIECES
OF INFORMATION, CAN YOU
CALCULATE THIS IS THE RISK AND
THEN CAN YOU MAKE A DECISION,
EXCEPT THE 1 IS THAT IF A
PATIENT IS NOT COVERED BY THEIR
INSURER OR COVERED BY MEDICARE
OR MEDICAID.
WHICH MEANS IT'S THE COMPANY OR
THE PATIENT WHOSE PAYING, THEN
THE CHARGES ARE GENERALLY HIGHER
THAN THEY WOULD BE IF IT WAS--IF
THE PATIENT WAS COVERED BY SOME
ORGANIZATION THAT WAS ABLE TO DO
NEGOTIATED RATE AND WHEN I SAY
HIGHER, I MEAN CONSIDERABLILY
HIGHER.
SO, YOU KNOW, THE NUMBER, A
HUNDRED THOUSAND DOLLARS WAS
THROWN OUT, WELL, I SUSPECT THAT
A HUNDRED THOUSAND DOLLARS
CHARGED TO LOCATION OR TO
ACCOMPANY IS NOT WHAT UNITED
HEALTHCARE OR MEDICARE WILL PAY.
AND IT'S RANDOM.
IT'S--THE ORGANIZATIONS THAT THE
CARE PROVIDING ORGANIZATIONS CAN
CHARGE WHATEVER THEY WANT.
SO THAT'S WHERE THE RISK CAN'T
BE CONTROLLED AND EVERYBODY GETS
REALLY NERVOUS IF YOU DON'T KNOW
WHAT THE RISK IS.
SO, WHAT WE'VE PROPOSED IN OUR
STUDIES IS THAT IF PATIENTS
COULD NOT BE COVERED BY
INSURANCE THAT THE COMPANY WOULD
BE THE PAIR OF LAST RESORT BUT
THAT THAT WOULD BE TIED TO
SOMETHING RELATED TO MEDICARE
RATE, EITHER MEDICARE RATE OR
SOMETHING + 10%, SOMETHING TO
START WITH.
AND IF THAT AGREEMENT WITH THE
INSTITUTION CAN BE REACHED, THEN
WE WILL MOVE AHEAD AND ALLOW
THAT INSTITUTION TO BE A TRIAL
SITE BUT MANY INSTITUTIONS WILL
NOT AGREE WITH THAT.
AND WE SHOULD CONTINUE TO MOVE
AHEAD WITH THESE INVESTIGATIONS.
SO REDUCING RISK.
I THINK WE NEED AN INSURANCE
ACTUARIAL ON THIS PANEL.
OR CONSIDERING RISK IS WHAT I
WILL SAY.
>> I THINK THERE WILL BE GOOD TO
TALK ABOUT POTENTIAL INSURANCE A
BIT MORE BUT FIRST I WANT TO
GIVE THE FLOOR TO SAMEER,
SHETH,.
>> YES, I APOLOGIZE FOR MISSING
SOME TODAY AND YESTERDAY,
BECAUSE I'VE BEEN DOING CLINICAL
STUFF, BUT THE QUESTION I HAD,
AND MAYBE PEOPLE HAD ENOUGH
EXPERIENCE TO ANSWER THIS IS
THAT, I STARTED GETTING INTO
THIS YESTERDAY A BIT BUT I THINK
WE STOPPED SHORT OF SPECIFICS
WHICH IS A STUDY THAT COVERED BY
AN IAED, YOU GUYS WON'T BE ABLE
TO SPEAK TO THIS BUT WHEN
THERE'S IDE COVERAGE FOR A
STUDY, THERE'S A CMS PATHWAY TO
COVER THE SURGICAL COST FOR
FUTURE BATTERY RECHANGE OR
REVISION REQUIRED FOR MEDICAL
REASON INFECTION, WHATEVER.
THIS IS FAIRLY ROUTINE, WE ARE
HAVE DONE THIS IN OUR OCD TRIAL
THAT WE'RE RUNNING, IS THIS A
PRACTICE THAT IS USED OFTEN AND
PEOPLE KNOW ABOUT ROUTINELY, THE
DEVICE HAS TO COME SOMEWHERE,
DONATED BY THE MANUFACTURE WOULD
BE 1 WAY, BUT THE ACTUAL
HOSPITAL IS SURGICAL COSTS GET
COVERED YOU TEENLY I BELIEVE, IS
THAT YOUR EXPERIENCE?
>> I DON'T BE IF WE HAVE OUR CMS
REBECCA REPRESENTATIVE HERE.
>> THE NAME IS IN A BOX, I THINK
HE'S HERE.
>> OKAY.
>> SO EXPERIENCE HAS BEEN THAT
WE SUBMIT THIS REQUEST TO CMS.
AND THUS FAR IT HAS ALWAYS BEEN
SUCCESSFUL BUT PERHAPS WE SHOULD
HEAR FROM THE PERSON WHO
ACTUALLY HAS THE ANSWER.
>> RIGHT.
SO I DON'T KNOW IF YOU CAN HEAR
ME.
>> YES, YES.
>> ALL RIGHT, GOOD.
SO YES, IF WE APPROVE THE IDE
FOR MEDICARE COVERAGE THEN
WE--IT DEPENDING ON THE
SITUATION WE USUALLY COVER THE
DEVICE IN ADDITION TO THE
ROUTINE SERVICES RELATED TO THE
DEVICE, DEPENDING ON THE
SITUATION, HOW WE DEFINE ROUTINE
SERVICES IS DEPENDENTOT
PARTICULAR STUDY, SO, WHYS THAT
DOES OCCUR ROUTINELY.
>> MAY I ASK, HOW OFTEN THAT A
COMPANY WILL MAKE THAT REQUEST
IS NOT ABLE TO GET IT APPROVED?
>> I CAN'T GIVE YOU A SPECIFIC
NUMBER BUT THERE ARE SOME TIMES
WHEN IT'S NOT APPROVED OR NOT
COVERED BY CMS BUT THAT'S FOR
REASONS RELATED TO THE TRIAL
DESIGN AND THE TYPE OF DEVICE,
FOR INSTANCE IF IT'S NEVER BEEN
USED IN HUMANS, WE WOULD THEN
NOT APPROVE IT BECAUSE THERE'S
NO CLINICAL DATA, THERE'S NO
DATA ON HUMANS.
>> DR. LI, I WOULD LIKE TO SAY
SOMETHING IMPORTANT.
SO WE HAVE SECURED COVERAGE FOR
MEDICARE FOR OUR SURGERIES,
HOWEVER, IF THE DEVICES ARE NOT
COMMERCIALLY AVAILABLE OR
COVERED, THERE'S NO WAY TO
PURCHASE THOSE DEVICES OR TO
BILL FOR THOSE DEVICES.
THEY HAVE TO BE NECESSARILY
DONATED BY THE MANUFACTURER AND
THEY'RE STUCK WITH THAT UNTIL
THEY DECIDE TO DISCONTINUE, YOU
KNOW, THE PRODUCTION OF THAT
DEVICE IF THEY DECIDE, RIGHT?
OR THEY GET THE FDA, THE FDA
APPROVAL AND THEN THAT DEVICE IS
COMMERCIALLY AVAILABLE.
THAT'S THE TRICKY THING OF THE
COVERAGE OF SURGERIES.
WHEN WHEN HARDWARE IS NOT--YOU
KNOW IT'S STILL VERY
EXPERIMENTAL.
>> SO CARL, MAY I ASK A
QUESTION, AND SINCE YOU
REPRESENT ALL OF CMS AND
WHATEVER YOU SAY HERE IS BEING
RECORDED, IS IT EVEN CONCEIVABLE
THAT IF CMS DETERMINES THAT
THERE'S AN IDE STUDY AND WILL
COVER, THAT INDIVIDUALS WHO HAVE
PARTICIPATED IN THAT STUDY, NOT
NEW PEOPLE BUT INDIVIDUAL WHO IS
HAVE BEEN PART OF THAT STUDY
WOULD BE ABLE TO RECEIVE SOME
TYPE OF CMS COVERAGE OR THERE
WOULD BE A CMS FAVORABLE
COVERAGE DECISION FOR THEIR POST
TRIAL CARE.
>> I'M SORRY, GUESS I'M NOT SURE
I UNDERSTAND THE QUESTION.
IF YOU DON'T MIND--
>> IT MAY BE BECAUSE I'M VERY
CONFUSED.
SO RIGHT NOW MY UNDERSTANDING
AND MY EXPERIENCE HAS BEEN THAT
CMS WILL IN MOST CASES PROVIDE
COVERAGE FOR PATIENTS WITH CLASS
3 MEDICAL DEVICES WHRO ARE IN
WELL DESIGNED IDE STUDIES AND
MOST, NOT MOST BUT MANY, MAYBE
MOST OF THE INSHERRERS WILL
FOLLOW MEDICARE'S GUIDE LINE, I
WOULD SAY MOST OF THE LARGER
INSURERS DO SO AND MAID CADE
GENERALLY DOES AS WELL.
BUT THEN WHEN THE STUDY ENDS,
THAT'S WHERE THE PROBLEM IS.
NOW GENERALLY FOR THESE DEVICE
STUDIES, WE ARE NOT TALKING
ABOUT 3000 PATIENTS AS IS THE
CASE WITH MANY PHARMA STUDIES,
WE'RE USUALLY TALKING ABOUT A
HUNDRED OR 200 PATIENTS OR A
HUNDRED OR 50 PATIENTS WHO WANT
TO CONTINUE TO RECEIVE CARE.
>> OR 10.
>> AND WE KNOW WHO THOSE PEOPLE
ARE, SO, ARE WE REALLY TALKING
ABOUT BIG BUCS?
I MEAN THIS IS NOT EVEN IN CMS'S
ROUND OFF AND IS IT POSSIBLE FOR
THERE TO BE SOME POLICY THAT
THOSE FEW PATIENT WHO IS HAVE
GONE THROUGH ALL OF THIS, WILL
HAVE SOME KIND OF A CARB OUT
WHERE CMS WOULD STILL COVER AT
LEAST SOME PORTION OF DEVICE
RELATED CARE.
>> MOST OF IT I HAVE TO GIVE A
QUESTION SOME THOUGHT.
I THINK THERE'S A LOT OF NUANCES
THAT ARE GOING HERE IN THAT THE
IDE IS TO--IS FOR FDA,
TECHNICALLY IT'S FDA CLEARED
DEVICES.
I MEAN THEY'RE TRYING TO GET
FULL APPROVAL AND SO, ONCE THAT
STUDY ENDS, I MEAN IT'S--WE ONLY
COVER IT DURING THE TRIAL.
I MEAN THAT FALLS FALLS WITHINR
REGULATIONS.
WE CAN'T--MY UNDERSTANDING IS,
THAT'S WHERE OUR AUTHORITY
FALLS.
AND YOU KNOW COMPANIES ARE
TRYING TO GET FDA APPROVAL.
NOW, I GUESS I WOULD HAVE TO
GIVE THAT THOUGHT FOR POST TRIAL
SUPPORT WITHIN THE CONFINES OF
AN IDERKS E TRIAL, WHETHER IT'S
A PIVOTAL TRIAL OR FEASIBILITY
TRIAL, I GUESS I WOULD HAVE TO
GIVE THAT SOME THOUGHT FOR POST
TRIAL CARE.
>> AND YOU KNOW THEN PERHAPS
ANOTHER--ANOTHER OPTION SINCE
SERVE'S GOT TO BE PART OF THIS
SOLUTION, AND OF COURSE, I
REPRESENT ALL INDUSTRY AND I
REPRESENT--NO, I DON'T I AM
SPEAKING FOR MYSELF RIGHT NOW
BUT IF THERE WAS AN
UNDERSTANDING THAT AFTER THE
OFFICIAL STUDY IS CONCLUDED
THERE WOULD BE SOME TYPE OF
EXTENSION AND THAT SOME COVERAGE
WOULD BE PROVIDED DURING THAT
EXTENSION.
I MEAN FROM A COMPANY
PERSPECTIVE, IT CAN TAKE A VERY
LONG TIME FROM THE TIME YOUR
STUDY ENDS UNTIL YOU GET TO THE
POINT WHERE FDA MAKES AN
APPROVAL DECISION.
THERE'S A LOT OF STUFF THAT HAS
TO HAPPEN AND ALSO, FOR DEVICES,
IT'S VERY STANDARD FOR FDA TO
REQUIRE SOME TYPE OF POST
APPROVAL STUDY AS A CONDITION OF
APPROVAL TO COLLECT ADDITIONAL
SAFETY AND EFFECTIVENESS DATA.
SO IT'S IN A LOT OF PEOPLE'S
INTEREST, PARTICULARLY THE
PERSON WHO'S BEING TREATED WITH
THE DEVICE TO CONTINUE TO GATHER
INFORMATION ON SAFETY AND
EFFECTIVENESS.
IF THERE IS SOME ABILITY FOR THE
COMPANY TO RECEIVE THE FINANCIAL
RECOGNITION FROM CMS, IN A STUDY
THAT IS A LONG-TERM EXTENSION,
UNTIL THERE IS SOME DECISION
ABOUT APPROVAL OR NOT, THEN, YOU
KNOW I THINK THIS COULD BE VERY
ATTRACTIVE FOR EVERYBODY,
INCLUDING FDA SO WHEN THEY MAKE
THEIR DETERMINE NATION, THEY
WILL HAVE THAT MUCH MORE SAFETY
AND EFFECTIVENESS DATA TO
CONSIDER.
>> SO I WANT TO MAKE SURE WE'RE
NOT FOCUSING SOLELY ON CMS FOR
US AS A PART OF THIS EXPERIENCE
BUT--
>> AGAIN I QUICK COMMENT, I
APPRECIATE THAT THOUGHT THOUGH,
BY THE WAY, YESTERDAY WAS A
DIFFERENT ISSUE BUT ANYWAY, SO
WE--I PERSONALLY IN OUR GROUP WE
DO REVIEW IDE APPLICATIONS SOME
OF THESE INVOLVE EARLIER
APPROVAL TRIAL BUT POST APPROVAL
STUDIES AND SO IF A XUSM DOES
APPLY FOR A POST APPROVAL
COVERAGE THROUGH MEDICARE, YOU
KNOW AND IF IT'S APPROVED THEN
WE APPROVE POST APPROVAL
STUDIES, THEY HAVE TO APPLY FOR
CMS FOR THAT COVERAGE.
>> WELL, SASKIA, THE REASON I'VE
BEEN PICKING ON CARL, AND NOT
REALLY PICKING ON HIM IS THAT.
>> AGENCY.
>> THAT I THINK WE'RE OFTEN
OTHER INSURERS ARE VERY
INTERESTED IN WHAT CMS DECIDES
AND WILL VER OFTEN FOLLOW THAT
LEAD.
>> YES, I CAN CONFIRM THAT, MANY
AGENCIES TEND TO FOLLOW US AND
WE ARE FULLY AWARE OF THAT AND
WE ARE AWARE OF IT.
>> DON'T GET ME WRONG, IT WILL
BE WOBDERFUL IF CMS COULD PLAY A
LARGER ROLE IN THIS AREA.
>> I KNOW IT'S GOING IN THE
TRANSCRIPT BUT I THINK WE DO
PLAY A PRETTY LARGE ROLE.
WE ARE THE LARGEST HEALTH
INSURANCE AGENCY I THINK IN THE
UNITED STATES.
SO I KNOW THAT'S GOING IN THE
TRANSCRIPT SO, I WILL SAY THAT.
>> I SEE 2 HANDS UP, BRANDY
ELLIS WOULD YOU LIKE TO GO
FIRST?
>> YEAH, I WOULD LIKE TO TIE IT
BACK TO SORT OF MY CORE CONCERN
WHICH IS, I HAVE PRIVATE HEALTH
INSURANCE AND I HAVE ATTEMPTED
TO APPLY FOR SOCIAL SECURITY,
DISABILITY WHEN I WAS DISABLED
AND SURPRISE TO LITERALLY NO 1,
IT WAS NOT APPROVED BUT ALSO I
WAS SICK BEFORE PARITY WAS
REQUIRED AND WE STILL HAVE
ISSUES WITH MENTAL DISORDERS AND
PARITY.
BUT MY CONCERN IS THIS, I HAVE
PRIVATE HEALTH INSURANCE AND AT
ANY TIME DESPITE MEDICARE
COVERING IT, FDA APPROVED ANY OF
THOSE THINGS, MY INSURER CAN
DECIDE THAT THEY'RE NOT GOING TO
COVER MAINTENANCE OR IF I NEED
IT REPLACED OR ANYTHING LIKE
THAT.
SO MY WORST CASE SCENARIO IS
THAT I GET ILL AGAIN, I HAVE TO
BECOME COMPLETELY DISABLED, I
HAVE TO THEN GET DISABILITY AND
THEN 24 MONTHS OF BEING ON
DISABILITY BEFORE MEDICARE WILL
COVER IT, AND SO ESSENTIALLY, IN
THE ABSENCE OF ME BEING ABLE TO
PAY FOR WHATEVER TREATMENT OUT
OF POCKET, IF MY PRIVATE INSURER
DOESN'T WANT TO COVER SOMETHING
THAT I'M LOOKING AT YEARS OF
UTTER DISABILITY ON THE HOPE
THAT MEDICARE WILL COVER IT.
AND YOU KNOW, IF--AND THAT'S NOT
AN UNREASONABLE FEAR.
LIKE THAT ABSOLUTELY COULD OCCUR
AND THERE'S NOTHING TO STEP IN
AND STOP THAT.
SO IF ME BEING PART OF THIS
TRIAL, IF I HAD ANYTHING THAT
SAID, HEY, WE'RE POST TRIAL
PARTICIPANTS, ARE IN A
MARKETPLACE HEALTH INSURANCE
PROGRAM THAT WILL COVER THIS,
YOU KNOW, YOU HAVE THIS
INSURANCE AND PRIVATE INSURERS
DON'T HAVE TO DEAL WITH IT,
FINE.
IF IT'S, YOU KNOW ACCESS TO
MEDICARE AS A POST TRIAL
PARTICIPANT, IF MY PRIVATE
INSURANCE WON'T COVER IT LIKE
FOR JUST THIS 1 THING BECAUSE
I'M IN MY 40S, YOU KNOW AND THIS
HAPPENED WHEN I WAS IN MY 30S,
IS I DON'T HAVE TO BE A MEDICARE
PATIENT BUT I CAN COUNT ON THEM
WHEN THEY DECIDED THAT THIS
QUALIFIED, THAT I'M NOT AT THE
MERCY OF PRIVATE HEALTH
INSURANCE, DECIDING WHETHER OR
NOT MY QUALITY OF LIFE IS
SUFFICIENT BECAUSE THESE ARE
VERY EXPENSIVE SURGERIES.
SO ANYTHING, ANY WAY THAT WE CAN
GET TO THE POINT WHERE IT'S NOT
RUSSIAN ROULETTE, AS TO WHETHER
A STAY ALIVE, SO IT CAN BE
MEDICARE, IT CAN BE AN INSURANCE
POLICY, HOWEVER WE CAN GET TO
THE POINT WHERE IT'S NOT
SOMEBODY ELSE DECIDING WHETHER
OR NOT THIS DEVICE IS WORTH IT
FOR MY LIFE.
>> I THINK IT BRINGS BACK UP A
SUGGESTION THAT WAS RAISED
EARLIER TO TODAY AND YESTERDAY
ABOUT WHAT IT COULD BE LIKE A
SPECIFIC INSURANCE POLICY, JUST
FOR POST TRIAL CARE THAT
DIFFERENT STAKEHOLDERS CAN
COMPARE IT TO AND THAT MIGHT
ALSO BE A WAY, I THINK TO SPREAD
SOME OF THE FINANCIAL RISK AS IT
COULD BE, IT COULD BE TRIAL
SPECIFIC OR IT COULD BE COVERING
LIKE THESE TYPES OF TRIALS.
ARE THERE ANY--
>> SOMEBODY I THINK TALKED ABOUT
YESTERDAY, I CAN'T REMEMBER WHO
IT WAS HAVING TRIED TO DO THAT
THROUGH LLOYDS OF LONDON OR
SWISS--
>> THAT WAS ME.
>> OKAY, SO CAN YOU SAY MORE
ABOUT THAT EXPERIENCE?
>> WELL THERE WERE SOME HUGE
INSURANCE COMPANIES THAT INSURED
STRANGE THINGS LIKE OCEAN LINE
CRUISERS AND YOU KNOW HOLLYWOOD
STARS WITH DRUG ADDICTION AND
MOVIE SETS, STUFF LIKE THAT, BUT
THE ISSUE IS THAT THEY NEED TO
BE ABLE TO CALCULATE RISK.
AND WE DON'T HAVE THE
INFORMATION TO GIVE THEM TO
CALCULATE RISK.
AND THE OTHER ISSUE IS, IT'S TOO
SMALL BECAUSE, YOU KNOW AS I
SAID, WELL WE'RE TALKING ABOUT A
HUNDRED PATIENTS AND SAMEER SAID
10 AND I THINK SAMEER'S ESTIMATE
IS VERY OFTEN ACTUALLY THE
NUMBER SO IT'S VERY DIFFICULT TO
GET A SMECIAL INSURER TO DO
THAT, HOWEVER THERE CERTAINLY
ARE SETTLEMENTS FOR, YOU KNOWIME
JUST THINKING ABOUT 9/11
DISASTER WHEN THERE WAS A FUND
AND THE PROCEEDS OF THAT FUND
ARE DISTRIBUTED BY A AN
EXECUTIVE WHO'S APPOINTED TO DO
SO, DOES NOT REPRESENT ANY OF
THE PARTIES SO KERRY ASHMONT WHO
WAS SO HELPFUL WITH US AND WE
WERE TALKING ABOUT IT AND I SAID
COULD WE PUT IT IN AN ESCROW
ACCOUNT AND COULD IT BE MANAGED
BY NIH AND SHE SPOKE ABOUT IT
WITH NIH AND IT DIDN'T SEEM TO
BE A GOOD FIT, AND THEN WE
THOUGHT WELL MAYBE IT COULD BE
MANAGED BY 1 OF OUR PROFESSIONAL
ORGANIZATIONS LIKE TD AMERICAN
EPILEPSY SOCIETY OR SOMETHING,
SOME DISINTERESTED, INTERESTED
BUT NOT INDIVIDUALLY INVOLVED
PARTY BUT YOU CAN SEE IS YOU
START TO SPIN THIS OUT THAT IT'S
VERY COMPLICATED TO FIGURE OUT
WHERE THOSE FUNDS WOULD REST IN
DECISIONHUMAN DISTRIBUTION.
>> BASES ON RULES, PROCEDURES
AND IT GETS COMPLICATED BUT THAT
DOESN'T MISCELLANEOUSLY MEAN
IT'S IMPOSSIBLE.
>> IF I COULD JUST COMMENT TO
MARTHA, THE IDEA OF PREFUNDING
AN INSURANCE POLICY HAS COME UP.
IT'S ROUGH BECAUSE AS YOU SAY
THE WHOLE IDEA OF INSURANCE IS
TO SPREAD THE RISK AND IF YOU
HAVE A SMALL POOL OF PATES ALL
OF WHOM ARE AT HIGH RISK, AND
LOOK AT CALIFORNIA RIGHT NOW
GETTING EARTHQUAKE AND FIRE
INSURANCE, CAN YOU GET IT BUT
IT'S GOING TO COST YOU AN ARM
AND A LEG SO MANY PEOPLE JUST
DON'T BOTHER.
SO I THINK THESE ARE SOME OF THE
THINGS WE SHOULD KEEP PURSUING,
I MEAN NOT I DON'T THINK WE
SHOULD THROW IN THE TOWEL ON
ANYTHING YET.
THE REALITY IS THIS IS HOW THE
INSURANCE INDUSTRY WORKS THIS IS
ALL ABOUT SPREADING THE RISK AND
THIS IS A HIGH RISK POOL OF
EVERYBODY AND WE DON'T
NECESSARILY HAVE A LOW RISK POOL
TO PAY FOR THAT, RIGHT?
SO--
>> I'M WONDERING IF NOT ALL
PATIENTS WOULD NEED TO RELY ON
THE PULL TO THE SAME EXTENT SO
SOME VARIATION TO THE EXTENT TO
WHICH PATIENTS WOULD NEED
SOMETHING LIKE THAT.
>> I THINK--
>> I THINK WE DON'T KNOW, DO WE
KNOW?
DO WE KNOW HOW OFTEN PATIENTS
END UP IN THIS SITUATION,
PATIENTS PARTICIPATE NOTHING
THESE TRIALS END UP IN A
SITUATION WHERE THEY'RE FACED
WITH COVERING LARGE MEDICAL
BILLS BY THEMSELVES.
I KNOW IT HAPPENS, BUT DO WE
KNOW HOW OFTEN?
>> YEAH, I THINK THAT'S A BIG
CHALLENGE, I JUST WANT TO
HIGHLIGHT THAT, THESE STEPS OF
INSURANCE POLICIES DO SEEM TO
EXIST IN AT LEAST IN OTHER
COUNTRIES AND THERE WAS 1 PERSON
YESTERDAY IN THE QAA WHO SAID HE
FOUND AN INSURER AND I DON'T
THINK IT WAS IN THE U.S. CONTEXT
AND HIS APPLICATION WAS NOT AND
I WANTED TO HIGHLIGHT THAT, I
DON'T WANT TO LET GO OF THE IDEA
BECAUSE I THINK IT MIGHT HELP
US.
>> COULD I JUMP IN, SO 1 THING
IS THAT MAYBE WE DON'T SEE IT,
MAYBE WE DON'T SEE IT IN THIS
CONTEXT AS A WAY TO SPREAD THE
RISK RIGHT, OR DISTRIBUTE THE
RISK, MAYBE WE SEE IT MORE AS A
FUND LIKE MARTY BROUGHT UP WHERE
LET'S SAY EACH COMPANY WILL
CONTRIBUTE SOME AMOUNT PER
PATIENT, OBVIOUSLY IT WOULD
REQUIRE DOG THE ASSESSMENT THAT
MARTY WAS BRINGING UP ABOUT SORT
OF QUANTIFYING THE RISK BUT HEY,
IF THERE'S SOMETHING WE'RE GOOD
AT IN THE UNITED STATES THEN WE
WANT TO VALUE THINGS SO WE CAN,
YOU KNOW WE CAN QUANTIFY THAT OR
THE DEVICE MANUFACTURE OR NIH IF
THEY'RE BEING THE SPONSOR, ET
CETERA, CAN CONTRIBUTE A SMALL
AMOUNT, NOT SMALL OR WHATEVER,
THE AMOUNT ENDS UP BEING ONCE WE
QUANTIFY IT, PER PATIENT AND
THEN ON A--YOU KNOW OBVIOUSLY IF
THEY NEED THE FUNDS LETTER ON,
THE PATIENT CAN APPLY TO COVER
WHATEVER THE INSURANCE WHATEVER
THEY CAN BE, THERE CAN BE AN
AMALSIS OF WHATEVER THE PATIENT,
THEMSELVES, ET CETERA HAVE MONEY
TO MAKE SOME OF THESE PAYMENTS.
SO THERE SEEMS TO BE A CMS
OPTION AS WELL, MAYBE THERE'S A
POLICING CHANGE THERE AND MAYBE
IT'S SOMETHING WE CAN WORK
TOGETHER ON CRAFTING WHAT THIS
WOULD LOOK LIKE AND WE CAN TRY
TO ARGUE FOR THAT SO THAT WE CAN
PROMODE--THE COMPANIES AND THESE
RESEARCHERS ARE DOING IS
MAGNIFICENT FOR THESE PATIENTS
SO IT'S SOMETHING WE NEED TO
CONTINUE, THESE ARE PEOPLE WHO
REALLY NEED THESE TREATMENTS AND
WE JUST NEED TO COMMUNICATE WITH
EACH OTHER TO TRY TO TWEAK HERE
AND THERE SO THAT WE CAN INSURE
THAT WE CAN HAVE ACCESS TO
THESE, YOU KNOW DEVICES IN THE
LONG-TERM.
>> IN THINKING ABOUT INSURANCE
POSSIBILITIES THERE'S A MODEL
LIKE THE COMPENSATION FUND WHICH
IS A TRUST, I BELIEVE AND I
THINK IT'S I SHOULD KNOW MORE
ABOUT IT THAN I DO, IT'S HOSTED
IF THAT'S THE RIGHT WORD, I
THINK BY THE FEDERAL GOVERNMENT.
NOW THERE'S A LOT OF CRITERIA,
YOU KNOW PEOPLE HAVE TO
DEMONSTRATE AND PASS CRITERIA TO
GET COMPENSATED BUT THERE IS
MONEY THERE FOR COMPENSATION
WHEN IN FACT THEY PASS CRITERIA,
SO MAYBE THERE'S A MODEL
THINKING OUT OF THE BOX SORT OF
LIKE THAT.
>> ALTHOUGH THERE WAS SOMETHING
ADOPTED THROUGH CONGRESSIONAL
LEGISLATION, IT'S POSSIBLE MODEL
BUT NOT AN EASY 1.
>> AND WILL REQUIRE POLITICAL
WILL AS WELL.
>> YEAH.
>> PERHAPS I CAN MAKE A REQUEST
OF THE EMPHASIS HERE BECAUSE
THIS IS A NEW WRINKLE SO WE'VE
TAKEN THE POLICY AS A SMALL
COMPANY THAT FOR OUR STUDIES SO
THAT WE WOULD REQUIRE THAT
INSURANCE REIMBURSEMENT BE
SOUGHT AND THAT THE PHYSICIAN
AND TEAM MAKE EVERY EFFORT AND
IF INSURANCE COULD NOT BE
ATTAINED THAT THE COMPANY WOULD
BE THE PAYOR OF LAST RESORT,
WHAT HAS HAPPENED NOW IS ABOUT A
THIRD OF THE INSTITUTIONS HAVE
REJECTED THAT BECAUSE THEY SAY
IT'S INEQUITABLE AND THEY WOULD
AGREE TO DO THE STUDY IF ONLY
INSURED PATIENTS WERE ABLE TO
PARTICIPATE SORE IF THE COMPANY
AGREED TO PAY FOR EVERYTHING BUT
NOT IF THERE WERE SOME PATIENTS
WHO WERE PAID BY INSURERS AND
ANOTHER GROUP OF PATIENT WHO IS
ARE PAID FOR BY THE COMPANY.
AND THIS IS--WE'RE AT THIS
MOMENT IN TIME, I AM WORKING
WITH CENTERS FOR A VERY LARGE
STUDY FOR AN IMPORTANT
INDICATION AND THIS HAS BEEN
VERY PERPLEXING AND THE
COMMENTS, WAS THAT THIS IS A
VERY UNETHICAL POSITION.
SO PERHAPS WE COULD HAVE AN
ETHICAL DISCUSSION ABOUT
PATIENTS WHO AT THE BEGINNING OF
THE STUDY WHERE PATIENTS FALL
INTO 2 CLASSES THOSE WITH
INSURANCE AND THOSE WITHOUT.
>> I BELIEVE I CAN SAY SOMETHING
ABOUT THAT I THINK I KNOW
ANOTHER INTERESTING ASPECT OF
THAT IS THAT MANY OF THESE
INSTITUTIONS ARE INSTITUTION
SAYS THAT REQUIRE INSURANCE TO
PROVIDE CARE, THEMSELVES, SOME
KIND OF EMERGENCY SO USUALLY
IT'S VERY DIFFICULT TO GET TO
THE CLINICIANS THAT ARE OFFERING
THESE TRIALS, ET CETERA, IN THE
FIRST PLACE, UNLESS YOU HAVE
INSURANCE, SO I THINK
THAT'S--DEFINITELY SOMETHING
THAT INSTITUTIONS NEED TO START
LOOKING AT MORE AND MORE, MORE
IN TERMS OF RISK AND BENEFITS
FOR THE SCIENCE, RIGHT AND WHAT
POPULATIONS ARE YOU TRYING TO
HELP HERE, WHERE WHY ARE YOU
TRYING TO GET IT FOR TRYING TO
GET THIS APPROVED AND SOMETIMES
THERE ARE PEOPLE FOR TREATMENT
RESISTANT CONDITIONS WHICH
GENERALLY THESE DEVICES WILL BE
FOR SYSTEM CONDITIONS WHERE THIS
IS REALLY NEEDED AND SO, I THINK
THE IRB, YOU KNOW MAYBE THERE'S
A WAY THAT WE CAN ALSO TRY TO
APPROACH IRBs OR PUT SOMETHING
TOGETHER WHERE THERE CAN BE SOME
KIND OF PRIORITY FOR DEVICES
THAT ARE TRYING TO ADDRESS
TREATMENT RESISTANT CONDITIONS.
EVEN IF THERE'S ISSUES WITH
INSURANCE.
BUT I WOULD JUST ADD I THINK
IT'S JUST ON PRINCIPLE FAIR TO
EXCLUDE PEOPLE BECAUSE THEY
CAN'T PAY OR THEY DON'T HAVE
INSURANCE, IF THEY HAVE NEEDS
MEDICAL NEEDS THAT ARE RELEVANT
AND IT ALSO GOES AGAINST THE
COMMENT THAT WAS MADE YESTERDAY
ABOUT THE NEED TO DIVERSIFY
TRIAL POPULATIONS.
>> WE ANTICIPATE THE 40% OR
INDIVIDUALS WHO WOULD BE INJURED
AND PARTICIPATING THE STUDY WILL
NOT BE SURE SO BASED ON THAT THE
COMPANY WHO MADE A STUDY WHO
WOULD BE IN THE STUDY WOULD HAVE
THE OPPORTUNITY TO DO SO AND
THEN WE FIND MANY IN THE
INSTITUTION WHERE THEY HAVE A
MEDICAL STANCE.
AND AND THAT FOR ETHICAL
REASONS, THEY WILL NOT CONSIDER
THAT.
SO I FERS HOPING AS PART OF
THIS, THERE COULD BE SOMETHING
THAT COMES OUT OF THIS ABOUT
WHAT IS--WHAT TYPE OF COMPANY
INVOLVEMENT IN PROVIDING SUPPORT
FOR THESE STUDIES, FINANCIAL
SUPPORT IS ETHICAL.
>> COULD I JUST CLARIFY FOR MY
UNDERSTANDING, THEY'RE SAYING
IT'S UNETHICAL TO HAVE 2 CLASSES
OF CITIZEN OR IT'S UNETHICAL TO
EXCLUDE PEOPLE WHO DON'T HAVE
INSURANCE?
>> NO, NO, THE FIRST.
SO YEAH, IF WE WENT FORWARD AND
FOR MANY INSTITUTIONS IF WE SAID
ALL RIGHT, WE'RE NOT PAYING FOR
ANYTHING, THEN THEY HAVE NO
PROBLEM WITH THAT.
BECAUSE IT'S THE SAME FOR
EVERYBODY, THERE'S NO PROBLEM
WITH ETHICS BECAUSE IT'S PEOPLE
INTERNAL AUDIT SURANCE BUT IF WE
SAY, WE WILL COVER THOSE WHO DO
NOT HAVE INSURANCE SO THEY CAN
PARTICIPATE BECAUSE IT'S
UNETHICAL BECAUSE WE HAVE 2
CLASSES, AND THEN THEY ALSO
RAISE THE CONCERN WHICH I THINK
IS LEGITIMATE IS THAT WELL,
THEN, YOU ARE SAYING THAT THE
PEOPLE WITH INSURANCE WILL BE
RESPONSIBLE FOR WHATEVER THEIR
CO-PAY IS.
BUT YOU'RE PAYING FOR THESE
OTHER PEOPLE WHO HAVE NO
INSURANCE SO THEY'RE NOT
RESPONSIBLE FOR THE CO-PAY AND
THAT'S NOT FAIR AND THEREFORE
THAT IS UNETHICAL.
NOW NAIS NOT EVERY INSTITUTION
BUT I WILL TELL YOU IT'S ABOUT
ONE-THIRD.
>> WE'VE HAD THAT DISCUSSION
HERE AND IN CONVERSATIONS WITH
OUR INSTITUTIONS AS WELL AND WE
SAY, WELL, THAT EXPENSE TOWARDS
THE INSURANCE GOES TOWARDS THE
PATIENT'S LIFETIME COVERAGE AND
IF YOU'RE--WE'RE TALKING ABOUT
CO POTENTIAL COMPLICATIONS OF
BRAIN SURGERY, THAT THEY COULD
EASILY BE RAMPING TOWARDS THE
MAXIMUM COVER BY THAT INSURANCE.
AND YOU KNOW THAT HAS BEEN 1 OF
THE THINGS THAT HAS BEEN RAISED
TO US AS THE POSSIBILITY OF, YOU
KNOW NOT BEING ABLE TO COVER,
YOU KNOW SEPARATELY PATIENTS
WITHOUT INSURANCE OR WITH
INSURANCE.
>> I LIKE TO TRANSITION US TO
CONSIDER WHAT THE NEXT STEPS
ARE, AS WE'RE GOING TO--THIS
WORKSHOP IS GOING TO END IN
ABOUT 50 MINUTES MAYBE--15
MINUTES MAYBE SO WHAT ARE THE
COMPLETE NEXT STEPS THAT WE
SHOULD ALL TAKE, WE SHOULD TAKE
1 SUGGESTION HAS BEEN TO GET
CLARIFICATION, THE FINANCIAL
LIKE THE AMOUNT OF CARE
PARTICIPANTS REQUIRE AND THE
FINANCIAL COSTS ASSOCIATE WIDE
THE CARE, I WOULD LOVE TO HEAR
SUGGESTIONS FOR NEXT STEPS.
>> I THINK 1 WONDERFUL THING
ABOUT THE QUAWRNTIFICATION AND
MAYBE 1 CONCRETE STEP IS MAYBE
GOING BACK TO THE SPONSORS OR
THE RESEARCHERS AND SEE IF THERE
IS A WAY TO IDENTIFY HOW OFTEN
DOES THAT HAPPEN THAT THE PERSON
LOSES ACCESS TO THE DEVICE OR
HAS ISSUES WITH INSURANCE, ET
CETERA.
SO HOW MANY PATIENTS ARE WE
TALKING ABOUT?
HOW MANY PATIENTS ARE GETTING
THIS DEVICE, I DON'T KNOW THAT
THERE'S A SINGLE PLACE WHERE WE
GET THAT INFORMATION SO I THINK
KNOWING THE NUMBER OF PATIENTS
THAT ARE GETTING, YOU KNOW
DEVICES, NEURAL DEVICES
IMPLANTED AND KNOWING HOW MANY
OF THESE PATIENTS YOU KNOW WHICH
CONDITIONS AND HOW MANY OF THESE
PATIENTS MAY BE LOSING ACCESS
AND WHY CAN HELP US START
QUANTIFYING THIS SO THAT THEN WE
CAN TAKE ACTUAL STEPS TO FIND
SOLUTIONS AND YOU KNOW,
UNFORTUNATELY WE NEED--WE NEED
TO KNOW HOW MUCH THIS WILL COST.
I MEAN THERE COULD BE SOME KIND
OF, YOU KNOW RULE WHERE WE JUST
START ARGUING AS BIOETHICISTS
WHATEVER, SOMETIMES PEOPLE CAN
ARGUE FOR THINGS THAT ARE JUST
NOT FEASIBLE, THAT'S DEFINITELY
NOT MY STYLE BUT I KNOW THAT
IT'S APPEALING AND YOU KNOW TO
TALK ABOUT PATIENT RIGHTS,
PERIOD.
BUT WE NEED TO, IF WE ARE GOING
TO MAKE ANY PROGRESS AND WE'VE
BEEN TALKING ABOUT THIS, YOU
KNOW FOR YEARS, NOW, IT'S
SOMETHING THAT MAKES IT KIND
OF--YOU KNOW IT GETS ME RILED UP
BECAUSE IT'S SOMETHING THEY
THINK WE NEED TO DO SOMETHING
ABOUT, BUT WE ALSO NEED TO TAKE
THE CLEAR STEPS AND MAKE SURE
THAT WE HAVE ALL OF THE
STAKEHOLDERS INVOLVED IN THIS
BECAUSE IF WE DON'T WORK
TOGETHER, WITH THE DEVICE
MANUFACTURES ON CMS AND EVERYONE
ELSE, WE'RE NOT GOING TO GET
ANYWHERE.
>> YEAH BUT I THINK THE DAILY
BASIS THEA GATHERING POINT IS A
GOOD 1 BUT I JUST WONDER IF A
RESEARCH GROUP FUNDED BY SAY A
NEUROETHICS GRANT FROM THE BRAIN
INITIATIVE WERE TO GO OUT AND
ASK YOU GUYS, SO TELL US HOW
MANY TRIAL SUBJECTS HAVE YOU HAD
WHO HAD TROUBLE WITH THIS AND
WHAT ARE THERE PROBLEMS?
AND GIVE US THE INFORMATION YOU
CAN WOULD WE GET THAT FROM YOU
OR WOULD YOUR INSTITUTION'S
LAWYERS START STREAMING ABOUT
HIPAA?
>> YOU KNOW, I MEAN MY
EXPERIENCE INTERVIEWING
RESEARCHERS THAT, HEY, ARE THEY
GIVING YOU THE SPECIFIC NUMBERS.
I DON'T KNOW LIKE WE WOULD HAVE
TO GO AND LOOK AT THOSE NUMBERS,
LOOK AT THE DIFFERENT TRIALS OF
THIS.
SO THIS WOULD BE SOMETHING
DIFFERENT BUT IN TERMS OF
NEUROETHICS AND CONDUCTING THE
INTERVIEWS WITH THE RESEARCHERS,
THEY HAVE BEEN EXTREMELY OPEN
WITH US, WITH COVID MANY
DIFFERENT--I MEAN WE COVERED
POST TRIAL ISSUES, WE'VE COVERED
MANY, YOU KNOW ISSUES ABOUT
REGRETS ABOUT LIKE HAVING
OFFERED DBS AND THAT KIND OF
THING AND I THINK THEY'VE BEEN
INCREDIBLY TRANSPARENT ABOUT IT.
OBVIOUSLY, IT'S DEIDENTIFIED BUT
THEY'VE BEEN VERY TRANSPARENT
AND WILLING TO ADDRESS THOSE
ISSUES.
>> YOU'RE MUTED.
>> SO SOMEONE SIGNED A CONSENT
FORM TO BE PART OF A TRIAL THEN
THE HIPAA REGULATIONS ARE
DIFFERENT.
AND IF THE CONSENT FORMS WERE
MODIFIED, TO INCLUDE THAT YOUR
INFORMATION MAY BE MADE
AVAILABLE TO NIH, THE FUNDING
ORGANIZATIONS TO DETERMINE
WHETHER--WELL, ACTUALLY LET ME
BACK UP, EVERY DEVICE
MANUFACTURE KNOWS EVERY TIME THE
DEVICE IS PLANTED WHETHER IT'S
SUPPOSED TO AND THAT'S AN FDA
REQUIREMENT TO TRACK DEVICES.
SO, IT'S NEVER FULL PROOF BUT
YOU NEED TO KNOW WHERE THAT
DEVICE IS AND THAT MEANS YOU
NEED TO KNOW WHICH PATIENT HAS
THE DEVICE AND WHERE THEY ARE
AND HOW CAN YOU CONTACT THEM IN
CASE THERE'S DEVICE PROBLEM.
SO YOU WILL NOT FIND IN PHARMA,
THE ABILITY TO TRACK PATIENTS
LIKE YOU CAN WITH DEVICES AND IT
WOULD SEEM TO ME, WE NEED TO BE
VERY REASONABLE AS PART OF NIH
AS PART OF A CLINICAL TRIAL TO
HAVE IN THERE SOME REQUIREMENT
THAT THE INVESTIGATOR PROVIDE
SOME INFORMATION ABOUT PATIENT
STATUS BUT PARTICULARLY FDA, WE
HAVE TO PROVIDE ANNUAL REPORTS
FOR FDA THAT REVIEW EVERYTHING
THAT'S HAPPENED TO ALL THE
PATIENTS FOR THAT YEAR.
AND THEY GO IN EVERY SINGLE
YEAR.
SO FDA ACTUALLY HAS THIS
INFORMATION FROM ALL OF THESE
STUDIES.
AND THEN LET'S TURN TO
PUBLICATIONS, THE TRIALS, IF YOU
FOLLOW THE CONCERT REQUIREMENT
WHEN YOU PUBLISH YOUR TRIAL YOU
HAVE TO HAVE A TABLE IN THERE
THAT SHOWS HOW MANY PEOPLE
DISCONTINUED IN THE REASONS THEY
DISCONTINUED.
SO THERE ARE SOURCES OF
INFORMATION.
I THINK WHERE I STRUGGLE IS TO
FIND OUT HOW MANY PEOPLE HAVE
EXPERIENCED WHAT BRANDY IS
AFRAID OF BECAUSE THAT'S OF
COURSE THE NIGHTMARE WE ALL
HAVE, IT'S THE NIGHTMARE THAT
BRANDY HAS AND BUT WE CAN NARROW
IT DOWN TO A POOL OF PEOPLE WHO
MIGHT HAVE BEEN AT RISK FOR
THAT.
>> I GUESS TO LOOK AT 1 THING,
TO SURVEY THE LANDSCAPE, TO KEEP
IN MIND FROM THE BRAIN
INITIATIVE SIDE OF THING SYSTEM
THAT EVERY PROJECT THAT IS DOING
THESE SORTS OF EXPERIMENTAL
STUDIES IN MUSEUM MANS WITH THE
CLINICAL TRIALS IS STILL
GENERALLY ACTIVE SO NONE OF THE
PROJECTS SINCE THE START OF THE
BRAIN INITIATIVE HAVE ACTUALLY
REACHED THE END OF THE STUDY
WHERE PATIENTS COULD RUN INTO
THOSE CHALLENGES, AT LEAST IN
TEMPERATURES OF GETTING HIT WITH
UNEXPLAINED COSTS AND SO ANY OF
THE 1S THAT ANY OF THE
UNEXPLAINED OR UNEXPECTED COSTS
HAVE AT LEAST BEEN ABLE TO BE
EITHER REBUDGETTED IN THE
EXISTING GRANT OR LIKE I SAID
YESTERDAY, YOU KNOW WE CAN
CONSIDER SUPPLEMENTAL FUNDING TO
ADDRESS SOME OF THOSE ISSUES,
YOU KNOW WITHOUT GETTING INTO
ANY INDIVIDUAL PROJECT AWARD OR
PATIENT ASPECTS.
SO, YOU KNOW IN LOOKING AT THAT
LANDSCAPE, IT IS A--YOU KNOW A
POTENTIAL FUTURE QUESTION OR
CONCERN BUT THE POPULATIONS TO
SURVEY MAY INVOLVE GOING BACK
FURTHER IN TIME TO EARLIER STAGE
PATIENTS FROM THE ORIGINAL STUDY
OF DBS FOR PARKINSONS OR THOSE
POPULATIONS TO FIGURE OUT WHAT
SOME OF THAT RISK MAY ACTUALLY
BE.
DID EMPLOY.
>> I'VE GOT JENNIFER, KAREN,
SARAH AND THEN I THINK WE WILL
WRAP UP.
>> THANKS I THINK THE QUESTION
ON THE TABLE RIGHT NOW ARE WHAT
ARE ACTIONABLE ITEMS THAT CAN BE
TAKEN.
I THINK IT'S NO DOUBT FOR THE
LAST 2 DAYS THIS IS AN EXTREMELY
COMPLEX ISSUE WITH A LOT OF
STAKEHOLDERS SO I APPLAUD YOU
GUYS FOR BRINGING SO MANY
STAKEHOLDERS TOGETHER TO HAVE
THIS DISCUSSION BUT I WOULD HATE
FOR IT TO GO TO THE WAY SIDE AND
I THINK IT'S REALLY IMPORTANT
THAT WE MAP OUT WHAT WE
DISCUSSED IN THE LAST 2 DAYS,
WHERE ARE THOSE ISSUES AND HAVE
ACTIONABLE ITEMS ON THEM BECAUSE
I DON'T THINK IT'S A SIMPLE
ANSWER THAT OH, WE CAN DO X, Y,
Z AND BE ABLE TO SOLVE THE
PROBLEM, BUT I THINK IT'S VERY
APPARENT THAT THERE'S SOME
THINGS ONCE WE MAP THIS OUT AND
LOOK AT OUR DISCUSSIONS THAT WE
CAN IMPLEMENT VERY QUICKLY.
BUT THAT CAN'T HAPPEN UNTIL WE
DO A FULL ASSESSMENT OF THESE
WHOLE DISCUSSIONS SO I THINK
THERE'S PROBABLY THE PRIORITY OF
ACTIONABLE ITEMS COMING AWAY
FROM THIS, OF WHERE ARE SOME OF
THE THINGS WE CAN SOLVE QUICKLY
AND THEN HOW ARE WE GOING TO
TACKLE SOME OF THESE MORE
COMPLEX 1S WHICH WILL REQUIRE A
LOT OF DIFFERENT AGENCIES
INDUSTRY, INSTITUTIONS TO BE
INVOLVED IN THE COMING UP WITH
THE SOLUTION.
>> THANK YOU AND JUST TO CLARIFY
MYSELF AND SEVERAL OTHER PEOPLE
ON THIS CALL WILL BE GOING BACK
TO WORK AND RELISTEN TO THESE
CONVERSATIONS WE'VE HAD AND SEE,
WHAT WE'VE LEARNED AND WHAT WE
COULD DO.
JUST TO CLARIFY.
THAT IS WHY WE DO THIS.
YEAH.
KAREN, PLEASE GO AHEAD?
>> HI, ALSO WANTED TO THANK
EVERYBODY FOR I THINK 1 OF THE
BEST WORKSHOPS I'VE BEEN AT FOR
THE NEUROETHICS WORKING GROUP,
JUST A GREAT STELLAR GROUP OF
PEOPLE AND OUT OF THE BOX
THINKERS AND PEOPLE WHO HAVE
BEEN LONG MISS FREE RADICALS
GENERATED OUR CONVERSATION SO
I'M SO FLAD TO HAVE OUR PATIENT
PARTICIPANTS HERE, LIVED
EXPERIENCE ADVOCATES AND ALSO
REPRESENTATIVES FROM INDUSTRY,
PEOPLE HAVE BEEN IN THE FIELD
TRYING TO SOLVE THESE PROBLEMS
LIKE MARTY.
SO I WOULD--I KNEW YOU WOULD
CREATE A GREAT MAP AND I KNEW
YOU ALL WOULD CAREFULLY COME
THROUGH AND I WAS GOING TO
REQUEST THAT MAYBE THERE BE KIND
OF A TABLE OR GRID THAT IS
CREATED THAT MAPS OUT LIKE GEN
SAID NEAR TERM, ISHT MEDIATE
TERM AND LONGER TOMORROW
PROJECTS AND SO, WHILE WE
CAN'T--IF A PROBLEM WE'RE TRYING
TO SOLVE IS KIND OF OFFERING
SOME KIND OF SECURITY BASICALLY
OR PROTECTION AND DERISKING THE
LONG-TERM CARE OF OUR
PARTICIPANTS OR WHATEVER
NOMENCLATURE WE SHOULDN'T LOSE
THAT LIKE WINSTON MENTIONED AND
WHO KNOWS WHO GETS TO DECIDE
WHAT THAT NOMENCLATURE IS, BUT
IN THE NEAR TERM THERE ARE
THINGS WE CAN DO WHICH IS JEN
AND BRANDY WERE A WEALTH AND
KNOWLEDGE AND WISDOM OF WAYS TO
THINK OUTSIDE OF THE BOX, THEY
SHOULDN'T HAVE BEEN PUT IN THAT
POSITION BUT THEY WERE.
AND I'VE HEARD JUST GREAT
INSIGHT FROM THEM AND 1 OF THE
THINGS THAT WAS MENTIONED THAT
WAS LOW HANGING FRUIT WERE THESE
REGISTRIES OR KIND OF COMMUNITY
SUPPORT SO MAYBE THESE ALREADY
EXIST TO SOME EXTENT AND SOME OF
THEM MIGHT BUT TO JUST AT LEAST
IN THE IMMEDIATE TERM, PEOPLE
CAN SAY WHAT ARE YOU DOING NOW
BECAUSE, YOU KNOW AND BRANDY
CAN'T FIELD ALL OF THEM BUT YOU
THIS IS WHAT I'M DOING NOW,
LET'S HELP EACH OTHER IN THE
SAME WAY YOU LET EACH OTHER
BORROW BATTERY PACKS.
IT WOULD BE--I KNOW WE WORRY
ABOUT THAT KIND OF INTERRUPTING
TRIALS ISSUES THE SCIENTIFIC
ABILITY, WE DON'T WANT PATIENTS
TALKING TO EACH OTHER BUT MAYBE
THERE IS SOMETHING THAT CAN BE
CREATED, MAYBE FROM THE NIH,
FROM FUNDING ENTITIES AND I HAVE
A NUMBER OF OTHER THINGS THAT
COULD BE NEAR TERM AND THERE'S
CLEAR RESEARCH AREAS THAT YOU
ALL MAP OUT.
I THINK, YOU KNOW IN THE
INTERMEDIATE TERM, MAYBE THERE'S
SOME THINGS OF NIH, A BUNCH OF
STAKEHOLDERS HERE, THE CITY
MODEL THAT WAS MENTIONED BY JEN,
THEY USED THIS MODEL WITH
PARTICIPANT LIVED EXPERIENCE
ADVOCATES, PARTICIPATING IN THE
GRANT REVIEWS AND I PERSONALLY
HAVE BEEN THE BIOETHICS REVIEWER
IN THERE ALONG WITH WALTER
JOHNSON AND WE'VE SEEN HOW
IMPORTANT THOSE PARTICIPANTS
WERE IN SHAPING THOSE GRANTS,
REALLY GOOD IDEAS WHERE
SOMETHING WAS FUNDAMENTALLY
FLAWED WHERE EVEN THE CLINICIANS
WRITING THEM DIDN'T HAVE ENOUGH
INSIDER KNOWLEDGE OF THE LIVED
EXPERIENCE SO MAYBE THAT'S
SOMETHING WE COULD DO IN THIS
CASE WITH THE POST TRIALS AND
LONGER TERM, I THINK THE HARDEST
1 IS WHAT JOHN SAID, THE
HORRIBLE INSURANCE AND
HEALTHCARE INSURANCEFRASTRUCTURT
LIFT UP BY OURSELVES BUT MAYBE
WE COULD SHIP AWAY AT
UNDERSTANDING THAT.
RHONDA WHO COME ACROSS THE
FLOOR, WE TALKED TO HER BEFORE
ABOUT BILLING ISSUES FOR
FUNCTIONAL OR NEUROLOGICAL
PATIENTS.
I MEAN, SHE IS A RICH RESOURCE
THAT WE COULD TALK WITH HER AND
CARL LI, THOSE ARE LONGER HARDER
STRUCTURES BUT SETTING THEM OUT
PIECE BY PIECE IN TIME FRAMES
MIGHT BE THE WAY TO MAKE THIS
FEEL MORE MANAGEABLE AND I'M
HAPPY OF COURSE TO, EVEN THOUGH
I'M UP IN THE MIDDLE OF THE
NIGHT, AND I'M HAPPY TO HELP YOU
ALL LATER THROUGH E-MAIL AND
STUFF.
SO PUT ME IN COACHES.
>> SARA?
>> SO I JUST WANTED TO MAKE A
COUPLE LAST POINTINGS, I REALLY
APPRECIATED THE 22 DAYS, 2, 1 IS
THAT WE SHOULD REALLY PAY
ATTENTION TO LOBBYING WHOMEVER
WE LOBBY TO CHANGE THE
COMPENSATION, THE VERY, VERY LOW
COMPENSATION RULES IN THIS
DOMAIN, AND I JUST THINK
COVERING THE COSTS OF CAREGIVERS
IS HIGH, YOU KNOW, PERSONAL
ATTENDANCE AND IT GOES BEYOND
GAS AND PARKING AND
THAT'S--THAT'S JUST BASIC
PARTICIPATION.
I THINK THAT SHOULD BE MADE
AVAILABLE FOR PEOPLE WHO ARE IN
THESE STUDIES.
I ALSO THINK IT WAS DAVID
Mc MULLINS IN THE Q&A WHO SAID
WE SHOULD HAVE SOME MODEL PLANS
FOR POST TRIAL COVERAGE, YOU
KNOW I WAS SAYING, MAYBE WE TAKE
HELEN AND PATRICIO AS A MODEL IS
PATHWAY GIVES TRIESIO SAID THIS
WASN'T SUSTAINABLE, BUT HAVING
SOMETHING SHORT-TERM OF HERE'S A
MODEL OF HOW WE'VE DONE THIS
SUCCESSFULLY EVEN IF IT'S NOT
LONG, LONG-TERM SUCCESSFUL WOULD
BE GREAT AND I THINK TO DO THAT
WELL, ACTUALLY WE NEED TO DO
SOME WORK ON TAXONOMY OF
DIFFERENT KINDS OF IMPLANTABLE
DEVICE STUDIES BECAUSE I THINK
THEY JUST--THE ISSUES ARE
DIFFERENT DEPENDING ON WHETHER
IT REALLY IS THE INDIVIDUAL
PARTICIPANT HAS THE POSSIBILITY
OF GETTING A HUGE THERAPEUTIC
BENEFIT THAT THEY CARRY WITH
THEM 24/7 OR IF THEY'RE REALLY
TRIALING SOMETHING THAT'S
TOTALLY NEW IN TERMS OF A WAY TO
MOVE OR MOVE SOMETHING ELSE THAT
THEY ONLY DO IN THE LAB, I THINK
THERE ARE REALLY INTERESTING
QUESTIONS FOR BOTH AND THEN I
THINK THERE ARE THINGS IN THE
MIDDLE WHERE DEVICES THAT ARE
DESOONED FOR SAY, STIMULATING
NEURAL PLASTICITY BUT THEN MIGHT
NOT BE NEEDED ARE--THEY'RE JUST
A DIFFERENT THING, TOO BECAUSE
THEY'RE POTENTIALLY VERY
THERAPEUTIC BUT NOT LONG-TERM
NECESSARY, SO I THINK WE'LLVILLE
TO HAVE DO SOME OF THAT
CONCEPTUAL WORK SAID THE
PHILOSOPHER.
THANKS.
>> SO, I THINK WITH THAT, IT'S
4:30.
SO, LET ME START TO WRAP UP,
JOHN WILL ALSO HAVE A WORD AFTER
ME.
LET ME START TO WRAP UP AND
THANKING EVERYBODY FOR TAKING
THE TIME DURING THESE 2 DAYS TO
WORK WITH US ON THIS REALLY
COMPLICATED TOPIC, INCLUDING ALL
OF THE PROFESSIONALS FROM
DIFFERENT AREAS AND VERY MUCH
ALSO ORIGINAL OUR PATIENT
PARTICIPANTS WHO ARE SHARE THEIR
INSIGHTS IN A WAY THAT OTHERWISE
WE COULDN'T HAVE HAD AS RICH A
DISCUSSION AND AS MEANINGFUL A
DISCUSSION SO I'M VERY GRATEFUL
FOR THAT.
MY PERSONAL OPINION IS THAT WE
MADE SOME PROGRESS, EVEN IF WE
STILL HAVE SOME WAYS TO GO
TOWARDS SOLVING THESE ISSUES
THAT WE CLARIFIED AND I'M EAGER
TO START WORKING ON THESE NEXT
STEPS AND AM GRATEFUL FOR MANY
OF YOU WHO IN THE CHAT HAVE
SAID, IT WOULD BE EAGER TO BE
INVOLVED MOVING FORWARD, SO
THANK YOU.
AND TO BE CONTINUED.
WITH THAT, I ALSO WANT TO THANK
NINNA WHO'S BEEN HELPING US
LEADING THE ORGANIZATION OF THIS
WORKSHOP, ALL THE NEW MEMBERS,
ALL THE PANELISTS AND THEN,
PASSING IT OVER TO YOU JOHN.
>> THANK SASKIA, AND I ALSO WANT
TO THANK EVERYBODY HERE FOR
THEIR PARTICIPATION AND
ORGANIZATION.
I LEARNED A TON.
THIS WAS--THESE HAVE BEEN ISSUES
THAT HAVE BEEN ON OUR MINDS FOR
A WHILE AND REALLY IT IS SO
HELPFUL TO HEAR ALL THE
DIFFERENT AND SIGNIFY VERSE
PERSPECTIVES FROM EVERYBODY HERE
TODAY, ESPECIALLY FROM OUR
PATIENTS AND PATIENT ADVOCACY
REPRESENTATIVES AND IT GOES
WITHOUT SAYING AND I SHOULD SAY
IT AND UNDERSCORE IT, YOU'RE THE
CRITICAL PARTNERS HERE WITH UTR
YOUR INVOLVED AND YOU'RE
COMMITTED NOT JUST YOUR
INVOFMENT, NONE OF THIS WOULD AT
ALL BE POSSIBLE.
THE 1 ISSUE I FOUND REALLY EYE
OPENING IS THAT WHEN WE'RE
TALKING ABOUT THE LENGTH OF THE
TRIAL PERIOD, YOU KNOW THE POST
TRIAL PERIOD, WE'RE NOT JUST
TALKING ABOUT A FEW YEARS, WHICH
YOU MIGHT IMAGINE, WE CAN
NAVIGATE AROUND BUT DECADES, 30
YEARS OR MORE AND THAT REALLY IS
TO BE SOBERING AND REALLY
UNDERSCORES HOW IMPORTANT IT IS
THAT WE ADDRESS THESE ISSUES.
I'M ALSO REMINDED ABOUT THE
INIQUITIES THAT ARE INHERENT IN
OUR HEALTHCARE SYSTEM THAT MUST
BE OVERCOME, NOT JUST IN TERMS
OF PATIENT'S ABILITY TO PAY OR
NOT PAY, BUT ALSO HAVING THE
RESOURCES TO SEEK OUT AND
ADVOCATE WHAT'S OUT THERE IT
THAT MAY BE LIFE SAVING TO THEM.
SO MANY OF US THAT ARE IN THE
BUSINESS AS IT WERE, BEING ABLE
TO ADVOCATE FOR 1'S SELF-WHETHER
IT INVOLVES YOU OR A LOVED 1 IS
NO EASY TASK AND THIS IS FOR
PEOPLE THAT HAVE ACCESS TO ALL
THE INFORMATION AND MUCH OF THE
INFORMATION THAT OTHERS DON'T.
SO I REALLY THINK THAT'S
SOMETHING WE NEED TO KEEP IN
MIND.
BRAIN HAS A COMMITMENT THAT THE
RESOURCES THAT WE INVEST IN OUR
RESEARCH FOR THE PURPOSE OF
HELPING HUMANS SHOULD NOT BE
GOING TO JUST THE PRIVILEGED
FEW, SO WE REALLY--THIS IS
REALLY PART OF OUR MISSION IS TO
PROVIDE RESOURCES AND EVENTUALLY
CURES FOR THE BENEFIT OF ALL.
AND BRAIN IS ALSO OCCUPYING THIS
UNIQUE SPACE, RIGHT?
IN EMERGING ITS OF INVASIVE
NEUROTECHNOLOGIES, I MEAN THESE
ARE POTENTIALLY GAME CHANGING
TECHNIQUES AND TECHNOLOGIES,
LIFE CHANGING TECHNOLOGIES, THAT
BY NATURE ARE IN THE EARLIEST
PHASES OF DEVELOPMENT, THESE ARE
THE ONLY THINGS WE FUND WHEREAS
EARLY PHASE DEVELOPMENT IN
HUMANS AND THIS GIVES RISE AS WE
HEARD OVER THE LAST FEW DAYS TO
VERY UNIQUE RISKS AS WELL AS
UNCERTAINTIES AND THIS IS I
THINK WHERE WE, YOU KNOW, GETS
QUITE COMPLEX.
I THINK WE WILL ALL AGREE THAT
ALL STAKEHOLDERS HAVE A
RESPONSIBILITY TO BETTER ADDRESS
POST TRIAL OR AS THE NAME OF THE
WORKSHOP IMPLIES CONTINUING
TRIAL RESPONSIBILITIES.
WE CHOSE THAT NAME VERY
INTENTIONALLY, CONTINUING TRIAL
RESPONSIBILITIES, AND THIS IS TO
REFLECT THE FACT THAT THE
PATIENT'S INVOLVEMENT GOES
BEYOND--OFTEN GOES BEYOND THE
LIFETIME OF A FORMAL TRIAL AND
THIS IS SOMETHING WE NEED TO
TAKE INTO ACCOUNT.
I SHOULD ALSO NOTE THAT WE HEARD
A LOT OF ISSUES THAT HAVE COME
UP AND NOT ALL CONTINGENCIES CAN
BE ACCOUNTED FOR.
THIS IS--THIS COULD BE THE ENEMY
OF BETTER OR GOOD ENOUGH TO
PERFECTION AND THERE WILL LIKELY
NOT BE 1 PERFECT SOLUTION TO
ADDRESS ALL THE GAPS WE
IDENTIFIED OVER THE PAST FEW
DAYS AND WHAT MANY OF YOU HAVE
BEEN LIVING THROUGH PERSONALLY
BUT I THINK FROM WHAT WE LEARNED
HERE, I'M HOPE EMPLOY WE WILL
AND CAN COME UP WITH CREATIVE
SOLUTIONS AND I REMIND MYSELF
AND ALL THE FOLKS THAT I WORK
WITH ON A PRETTY REGULAR BASIS
THAT INNOVATION OF BRAIN DOES
NOT STOP WITH THE--DURING THE
ACTUAL SCIENCE, WE HAVE TO FIND
CREATIVE SOLUTIONS, WE NEED TO
INNOVATE IN THIS SPACE AS WELL,
SO JUST IN CLOSING FROM BRAIN'S
POINT OF VIEW, FROM MY POINT OF
VIEW, THIS WORKSHOP SITS MORE
TOWARD THE BEGINNING AND NOT THE
END OF A VERY IMPORTANT
CONVERSATION.
OUR DISCUSSIONS WITHIN OUR
PROGRAM, ACROSS NIH MORE BROADLY
FOR LONGER TERM SOLUTIONS AS
WELL AS WORK AROUNDS IN THE MEAN
TIME THESE ARE ALL ACTIVE AND
ONGOING, I CAN ASSURE YOU WE ARE
POKING AROUND AND SEEING WHAT WE
CAN DO WHILE WE WORK TOWARD
THESE LONGER SOLUTIONS WHICH
WILL TAKE STAKEHOLDERSERS LONGER
INVOLVEMENT TO GET DONE.
AND YOU CAN SEE MORE OF THIS
ABOUT THE WORK IN PART OF OUR
GREAT NEUROETHICS WORKING GROUP
AND I WANT TO THANK YOU AGAIN
FOR BEING HERE AS WELL AS FOR
OUR NEURY ETHICS WORKING GROUP
AND OUR CHAIRS CHRISTINE GRADE
SKPE BAKUGAN HANK GREELY, I WILL
LEAVE IT AT THAT. WE HAVE A LOT
OF WORK TO DO, WE HAVE GREAT
IDEAS AND AS MANY OF YOU
MENTIONED HERE, LET'S NOT LET
THIS FALL BY THE WAY SIDE, LET'S
USE WHAT WE LEARNED HERE AS A
STIMULUS TO REALLY GET GOING ON
SOLVING THIS SET OF PROBLEMS.
>> THANK YOU SO MUCH JOHN.
AND WITH THAT I WILL ECHO WHAT
WE HEARD FROM OUR CO MODERATORS
AND FROM JOHN, IT'S BEEN A
REALLY HUMBLING AND RICH
DISCUSSION THAT I WILL BE
DIGESTING FOR A VERY LONG TIME
AFTER THIS.
I REALLY LOVED YOUR COMMENT,
JOHN THAT SHOULD THE BEGINNING
OF THE CONVERSATION SO AGAIN, A
HUGE THANK YOU TO EVERYBODY, OUR
PANELISTS, THE NEWG, TO EVERYONE
AND NIH STAFF AND WE ARE
ADJOURNED.
THANK YOU AGAIN SO MUCH