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I WANT TO WELCOME EVERYONE TO
TODAY'S SESSION OF ETHICS GRAND
ROUNDS FROM THE NIH CLINICAL
CENTER.
I'M DAVE WENDLER, WE'RE THE HOST
FOR THE ETHICS GRAND ROUNDS.
WE DO THAT FOUR TIMES A YEAR AN
FOR PEOPLE WHO ARE PLANNING
AHEAD, OUR NEXT SESSI SESSIONS E
SPRING WILL BE THE FIRST
WEDNESDAY IN FEBRUARY.
AND THE FIRST WEDNESDAY IN
APRIL.
I THINK THOSE WILL BE REALLY
WONDERFUL SESSIONS.
I HOPE YOU CAN JOIN US.
THE FIRST WEDNESDAY IN FEBRUARY
AND THE FIRST WEDNESDAY IN
APRIL.
SO OUR DEPARTMENT HOSTS THESE
ETHICS GRAND ROUNDS AND THE GOAL
IS TO PRESENT WHAT WE REGARD AS
INTERESTING IMPORTANT ETHICAL
QUESTIONS, TYPICALLY IN CLINICAL
RESEARCH, CLINICAL CARE AND/OR
HEALTH POLICY MORE GENERALLY AND
TO PRESENT THOSE TO THE NIH AND
BROADER COMMUNITY AND TO HAVE
SOME DISCUSSION ON THOSE ISSUES.
SO AS A REMIND E A REMINDER, WET
SPOKESPEOPLE, WE'RE KNOLL POLICY
MAKERS, WE'RE NOT REPRESENTING
ANYBODY ELSE, WE'RE CERTAINLY
NOT REPRESENTING THE
INSTITUTIONS TO WHICH WE'RE
AFFILIATED.
WE'RE JUST GOING TO GIVE YOU OUR
OWN VIEWS.
THE TOPIC IS
WHETHER OR NOT RESEARCH
PARTICIPANTS SHOULD SHARE IN THE
PROFITS THAT RESULT FROM
CLINICAL TRIALS IN WHICH THEY
PARTICIPATE.
THIS IS AN ISSUE THAT I'VE BEEN
WANTING TO DO ETHICS GRAND
ROUNDS ON FOR A NUMBER OF YEARS,
SO I'M REALLY EXCITED TO FINALLY
GET A CHANCE TO PRESENT IT.
SOMETIMES CLINICAL TRIALS LEAD
TO ENORMOUS PROFITS AND THOSE
PROFITS CAN BE SHARED BY
RESEARCHERS, BY THE SPONSORING
COMPANIES, BY INVESTORS, AND BY
A LOT OF OTHER PEOPLE, BUT THEY
TYPICALLY -- THEY'RE NOT SHARED
WITH RESEARCH PARTICIPANTS.
THE QUESTION FOR TODAY IS JUST
WHETHER OR NOT THAT'S AN
APPROPRIATE POLICY OR NOT.
SO THAT'S THE ISSUE THAT WE'RE
GOING TO FOCUS ON.
TO PRESENT THE CASE WE HAVE JEFF
CONE, CHIEF OF THE LABORATORY OF
INFECTIOUS DISEASES AT THE
NIAID.
LIKE ME, JEFF HAS BEEN AROUND
THE NIH FOR A LONG TIME.
THIS PROBABLY ISN'T ON HIS CV
BUT WHEN I FIRST CAME TO THE
NIH, JEFF WAS THE CHAIR OF THE
NIAID IRB, HE WAS WONDERFULLY
WELCOMING TO ME AND REMAINS
AFTER ALL OF THESE YEARS ONE OF
THE BEST IRB CHAIRS THAT I'VE
EVER WORKED WITH.
SHOULD BE ON YOUR CV, JEFF.
JEFF WAS NOT A PRINCIPAL IN THIS
CASE.
JEFF IS GOING TO PRESENT THE
CASE AND THEN I'M GOING TO
PRESENT A VIEW, THE AFFIRMATIVE
ARGUING IN SOME PIECES RESEARCH
PARTICIPANTS SHOULD SHARE IN THE
PROFITS OF THE RESEARCH TO WHICH
THEY PARTICIPATE, AND THEN GLENN
COHEN IS GOING TO COMMENT ON MY
VIEWS AND ALSO JUST THE GENERAL
ISSUE.
GLENN COHEN, IN ADDITION TO
BEING ONE OF THE WORLD'S LEADING
EXPERTS ON LAW AND BIOETHICS, IS
ALSO THE JAMES A. ATTWOD AND
LESLIE WILLIAMS PROFESSOR OF LAW
AT HARVARD LAW SCHOOL.
GLENN -- DOING A WONDERFUL JOB
AND OF COURSE WE CAN'T LET
PEOPLE GET AWAY WITH THAT
WITHOUT SOME SORT OF
RAMIFICATIONS AND FOR GLENN,
WE'VE DRAGGED HIM BACK IN AND
HE'S KINDLY AGREED TO DO ANOTHER
ONE FOR US.
SO TO GET US GOING, JEFF.
>>THANK YOU.
SO AS DAVE MENTIONED, SHOULD
RESEARCH PARTICIPANTS SHARE IN
THE PROFITS?
SO I HAVE NO CONFLICTS OF
INTEREST WITH RESPECT TO THE
PRESENT PRESENTATION.
I SHOULD MENTION THAT PROFESSOR
COHEN, THE DISCUSSANT AND I,
HAVE THE SAME LAST NAME AND WE
PROBABLY ARE RELATED FROM
SEVERAL THOUSAND YEARS AGO, BUT
WE ARE NOT DIRECTLY RELATED, AND
THIS IS THE FIRST TIME I'VE MET
HIM.
SO NO CONFLICT OF INTEREST
THERE.
LEARNING OBJECTIVES FOR TODAY
ARE TO DESCRIBE RESEARCH ON
MONOCLONAL ANTIBODIES AGAINST
INFECTIOUS AGENTS, AND DISCUSS
THE CASE OF A RESEARCHER WITH
POTENTIALLY POTENT ANTIBODIES,
AND TO RAISE THE QUESTION OF
WHETHER RESEARCH PARTICIPANTS
SHOULD SHARE IN PROFITS.
SO MONOCLONAL ANTIBODIES ARE
NATURALLY OCCURRING ANTIBODIES
OR I SHOULD SAY NATURAL
OCCURRING ANTIBODIES ARE AN
IMPORTANT PART OF OUR IMMUNE
SYSTEM.
MONOCLONAL ANTIBODIES, WHICH ARE
HUMAN-MADE, ARE DERIVED FROM THE
SINGLE B CELL FROM A
PARTICIPANT, AND B CELLS, OF
COURSE, ARE A TYPE OF WHITE
BLOOD CELL.
AND MONOCLONAL ANTIBODIES ARE
USED TO PREVENT AND ALSO TO
TREAT VARIOUS INFECTIONS, AS WE
KNOW FROM THE COVID-19 PANDEMIC.
SO AN NIH LABORATORY HAS A STUDY
WHICH OBTAINS BLOOD SAMPLES FROM
PARTICIPANTS INCLUDING NIH
EMPLOYEES.
THE BLOOD SAMPLES ARE USED TO
DEVELOP MONOCLONAL ANTIBODIES
AGAINST INFECTIOUS AGENTS OF
MEDICAL IMPORTANCE.
A RESEARCHER IN THE LABORATORY,
AND AS DAVE MENTIONED, I WAS NOT
THE RESEARCHERS, FOUND THAT
BLOOD FROM PERSONS INFECTED WITH
COVID-19 CAN BE USED TO MAKE
MONOCLONAL ANTIBODIES AGAINST
DIFFERENT STRAINS OF SARS-COV-2.
THE COLLECTION STUDY IS DESIGNED
TO USE THE B CELLS FROM THE
PERSONS OR PERSON WHOSE SERUM
SAMPLE HAS THE MOST POTENT
ANTIBODY FOR USE IN DEVELOPING
MONOCLONAL ANTIBODIES.
SO THE RESEARCHER SCREENS
INDIVIDUALS, AND THOSE WHO HAVE
THE HIGHEST ANTIBODY LEVELS ARE
OFTEN CHOSEN IN TERMS OF
ISOLATING B CELLS FOR DEVELOPING
MONOCLONAL ANTIBODIES.
THE RESEARCHER HIMSELF DEVELOPS
COVID-19, AND AFTER HE RECOVERS,
HE ENROLLS IN THE SAMPLE
COLLECTION STUDY IN ORDER TO
CONTRIBUTE HIS SERUM AND CELLS
IN THE DEVELOPMENT OF MONOCLONAL
ANTIBODIES AGAINST SARS-COV-2.
SURPRISINGLY WHEN THE RESEARCHER
EVALUATES SAMPLES FROM ALL THE
PARTICIPANTS IN THE COLLECTION
STUDY, HE DISCOVERS THAT HIS
SAMPLE HAS THE MOST POTENT
ACTIVITY AGAINST SARS-COV-2.
AND BASED ON THE PROTOCOL, THE
RESEARCHER PROPOSES TO USE HIS
OWN CELLS TO DEVELOP THE NEXT
ROUND OF MONOCLONAL ANTIBODIES
AGAINST SARS-COV-2, BECAUSE HIS
CELLS CORRESPOND TO SERA THAT
HAS THE HIGHEST LEVEL OF
ANTIBODY TO SARS-COV-2.
NOW THE ANTIBODIES DISCOVERED
MAY BE SOME OF THE MOST
EFFECTIVE AGAINST SARS-COV-2,
AND IF THEY ARE, THE ANTIBODIES
COULD BE USED TO DEVELOP
PRODUCTS WHICH ARE WIDELY --
WHICH COULD BE USED WIDELY AND
COULD YIELD SIGNIFICANT PROFITS.
SO IN TERMS OF THE RESEARCHER
CONTRIBUTIONS, RESEARCHERS MAKE
IMPORTANT CONTRIBUTIONS TO THE
STUDY IN WHICH THEY ARE
INVOLVED.
AND IN THE PROCESS, RESEARCHERS
SOMETIMES CONTRIBUTE TO THE
DEVELOPMENT OF PRODUCTS WHICH
LEAD TO SIGNIFICANT PROFITS.
NOW RESEARCHERS MAY BENEFIT, AND
WHEN THEY DO, THEY MAY BENEFIT
FINANCIALLY.
AND AT THE NIH, RESEARCHERS
MIGHT BE INVENTERS ON A PATENT.
IN ADDITION, BOTH THE
RESEARCHERS AND THEIR
LABORATORIES CAN RECEIVE
ROYALTIES.
NOW IN TERMS OF THE PARTICIPANT,
THE ONE WHO GIVES THE BLOOD,
RESEARCH PARTICIPANTS MAKE
IMPORTANT CONTRIBUTIONS TO THE
STUDIES IN WHICH THEY ARE
INVOLVED.
IN THE PROCESS, PARTICIPANTS
SOMETIMES CONTRIBUTE TO THE
DEVELOPMENT OF PRODUCTS WHICH
LEAD TO SIGNIFICANT PROFITS.
SOL THE RESEARCHER WONDERS
WHETHER THE PARTICIPANTS,
INCLUDING HIMSELF, SHOULD
BENEFIT FINANCIALLY.
SHOULD RESEARCH PARTICIPANTS
BENEFIT FINANCIALLY WHEN THEY
CONTRIBUTE TO STUDIES WHICH LEAD
TO SIGNIFICANT PROFITS?
SO THE STANDARD PRACTICE IS FOR
RESEARCHERS BUT NOT RESEARCH
PARTICIPANTS, THAT IS, NOT THE
PEOPLE WHO DONATE THE SAMPLES,
TO SHARE IN THE PROFITS OF
STUDIES TO WHICH THEY
CONTRIBUTE.
POTENTIAL PARTICIPANTS ARE
USUALLY INFORMED OF AND REQUIRED
TO AGREE TO THIS PRACTICE DURING
THE CONSENT PROCESS.
SO THE CONSENT THAT'S USED IN
THIS LABORATORY IS AS FOLLOWS:
IN SOME CASES, THE NIH AND THE
RESEARCH TEAM FOR THIS STUDY MAY
DEVELOP ANTIBODIES FROM YOUR
BLOOD TO THE VIRUS BEING
STUDIED.
THIS MEANS IT IS POSSIBLE THAT
THE RECIPIENTS OF THIS STUDY
COULD LEAD TO PAYMENTS TO THE
NIH.
BY LAW, THE GOVERNMENT IS
REQUIRED TO SHARE SUCH PAYMENTS
WITH THE EMPLOYEE INVENTORS.
YOU, THAT IS, THE PERSON WHO
DONATED THE BLOOD, WILL NOT
RECEIVE ANY MONEY FROM THE
DEVELOPMENT OF THESE ANTIBODIES.
SO THE QUESTIONS FOR TODAY ARE:
WHO SHOULD SHARE IN PROFITS THAT
RESULT FROM PRODUCTS DEVELOPED
IN RESEARCH STUDIES?
SHOULD THE RESEARCHERS SHARE IN
PROFITS?
SHOULD THEIR LABS SHARE IN
PROFITS?
AND SHOULD THE PARTICIPANTS WHO
DONATED THE SAMPLES SHARE IN THE
PROFITS?
SO I'M GOING TO STOP THERE AND
DR. WENDLER CAN CONTINUE.
>>THANKS VERY MUCH, JEFF.
SO AS I GET STARTED HEE I JUST
HAD A HERE, I JUSTHAD A COUPLE R
ANYBODY WHO HAS COME IN LATE.
WE TAKE QUESTIONS TO ASK
QUESTIONS, GO AND FIND THE LIVE
FEEDBACK BUTTON ON THE WEBSITE,
CLICK THAT, AND YOU CAN ASK YOUR
QUESTION AND THOSE QUESTIONS
WILL COME TO ME.
AGAIN, WE ALSO GIVE CME CREDIT
THROUGH HOPKINS TO CLAIM THAT
FOR ANYBODY WHO CAME IN LATE,
YOU TEXT 44534 TO THE PHONE
NUMBER ON THE SLIDE.
AND THE LAST THING IS WE HAVE
EVALUATIONS, THERE ARE PDFs
AVAILABLE ON THE WEBSITE FOR
ANYBODY WHO WOULD LIKE.
WE'RE VERY INTERESTED IN
THOUGHTS, COMMENTS AND CERTAINLY
SUGGESTIONS FOR FUTURE ETHICS
GRAND ROUNDS IF YOU HAVE THOSE,
FEEL FREE TO PUT THEM IN THE
EVALUATION FORM OR, MAYBE EVEN
BETTER, FEEL FREE JUST TO EMAIL
ME DIRECTLY.
FOR PEOPLE WHO ARE INTERNAL, MY
EMAIL IS ON THE GLOBAL, IT'S
DWENDLER@NIH.GOV.
SO JEFF PRESENTED A REALLY NICE
CASE.
WHAT I LIKE ABOUT THIS CASE IS
THAT IT COMPARES DIRECTLY THE
RESEARCHER CLAIMS TO PROFITS TO
RESEARCH PARTICIPANTS CLAIMS TO
PROFITS UNDER CURRENT PRACTICE.
SO IF THIS PRODUCT ENDS UP WITH
PROFIT AND THE RESEARCHER IS
INVOLVED IN THAT AS A
RESEARCHER, UNDER STANDARD
PRACTICE THEY WOULD LIKELY SHARE
IN THE PROFITS HOWEVER, AS A
RESEARCH PARTICIPANT THEY
WOULDN'T AND THE QUESTION IS
WHAT WE THINK ABOUT THAT, IS
THAT APPROPRIATE POLICY OR NOT.
SO I DON'T HAVE ANY CONFLICTS OF
INTEREST WITH RESPECT TO THIS
PRESENTATION.
AND HERE ARE MY THREE LEARNING
OBJECTIVES.
SO THE QUESTION THAT I WANT TO
CONSIDER IS THE FACT THAT
RESEARCH PARTICIPANTS CONTRIBUTE
TO THE DEVELOPMENT OF DRUGS
WHICH RESULT IN BILLIONS AND
BILLIONS FOR ANYBODY WHO
REMEMBERS -- IN THE BACK OF YOUR
MIND SOMEWHERE WHEN YOU HEAR
THAT PHRASE, SO BILLIONS AND
BILLIONS OF DOLLARS IN PROFITS.
THIS IS A REALLY NICE SUMMARY OF
RECENT WORK ON THE CONTRIBUTIONS
RESEARCH PARTICIPANTS MAKE.
SO THIS FACT HAS LED TO DEBATE
OVER WHETHER CURRENT PRACTICE,
AGAIN, WHICH IS THAT PROFITS ARE
NOT SHARED WITH PARTICIPANTS,
WHETHER OR NOT THAT SHOULD BE
CHANGED.
AND FOR A NUMBER OF INTERESTING
REASONS, A LOT OF THE FOCUS OF
THAT DEBATE, THAT'S A DEBATE
THAT APPLIES TO RESEARCH
PARTICIPANTS OF ANY TYPE, BUT
FOR A NUMBER OF DIFFERENT
REASONS, THE FOCUS HAS BEEN AS
WE WILL FOCUS TODAY ON SAMPLE
DONORS AND MANY ARE FAMILIAR
WITH THE CASE OF HENRIETTA
LACKS.
SO WE'RE ASKING WHETHER OR NOT
EXISTING PRACTICE IS
APPROPRIATE.
THE FIRST THING I THINK IS
IMPORTANT TO NOTE IS THAT
WHENEVER WE EVALUATE PROPOSED
CHANGES TO ANY EXISTING
PRACTICE, WE NEED TO BE CAREFUL
TO AVOID A STATUS QUO BIAS.
SO HOW DOES THAT WORK?
WELL, BASICALLY, IF THERE'S SOME
PRACTICE THAT'S BEEN AROUND FOR
A WHILE, WE'VE GOTTEN USED TO
IT, AND WE TEND TO ACCEPT THOSE
PRACTICES AND POLICY.
THEY JUST BECOME EMBEDDED AND
PART OF OUR LIVES THAT WE JUST
ACCEPT THEM TO FIGHT WHATEVER
PROBLEMS, CONCERNS THEY MIGHT
RAISE.
BUT IN CONTRAST, THE SAME
PROBLEMS, THE SAME WRIN ELS AS N
THE SLIDE OR EVEN FEWER MIGHT
LEAD US TO REJECT EACH WHEN IT
MIGHT BE SIMILAR TO OR EVEN
BETTER THAN EXISTING PRACTICES
SO WE WANT TO AVOID STATUS QUO
BIASES LIKE THAT, WE WANT TO
EVALUATE THINGS FAIR, EVENLY AND
ON THEIR OWN TERMS.
SO HERE JUST ONE EXAMPLE.
I THINK THE STATUS QUO BIAS IS
INFORMING A LOT OF THE VIEWS AND
A LOT OF THE SUPPORT FOR
STANDARD PRACTICE.
SO A LOT OF COMMENTATORS AGREE
WITH STANDARD PRACTICE THAT
RESEARCH PARTICIPANTS SHOULDN'T
SHARE IN PROFITS, BUT I THINK A
LOT OF TIMES THOSE ARGUMENTS ARE
BASED ON DIFFERENT KINDS OF
STATUS QUO BIAS.
SO HERE'S JUST ONE EXAMPLE FROM
A VERY PROMINENT ARTICLE IN THIS
REGARD.
SO VERY FEW TISSUE DONORS, THE
AUTHORS POINT OUT, WILL
CONTRIBUTE CELLS THAT BECOME
FINANCIAL BLOCKBUSTERS.
SHOULD WE REWARD PATIENTS FOR,
IN A SENSE, WINNING THE LOTTERY?
AND THIS IS ABSOLUTELY RIGHT,
THAT WHEN WE ARE PARTICIPANTS IN
A TRIAL, WE HAVE NO IDEA WHETHER
OR NOT A TRIAL WE CONTRIBUTE TO
MIGHT HAVE BILLIONS OF DOLLARS
OF PROFITS, IT'S IN A CERTAIN
SENSE LUCKY WHICH ONES DO AND
WHICH ONES DON'T, SO IF WE SHARE
PROFITS WITH PARTICIPANTS, WE'LL
BE IN EFFECT REWARDING THEM FOR
THAT LUCK.
AND THAT MIGHT SEEM PROBLEMATIC.
WHILE I CAN UNDERSTAND WE MIGHT
NOT LIKE THAT, JUST WANT TO
POINT OUT THAT THAT'S THE WAY
CURRENT PRACTICE WORKS WITH
RESPECT TO THE OTHERS WHO
PROFIT, WHO SHARE IN THE
PROFITS.
SO TAKE RESEARCHERS IN THE
COMPANIES WHO SUPPORT THE
PRODUCTS.
SOME OF THEM GET LU LUCKY AND Y
EARN HUNDREDS OF BILLIONS OF
DOLLARS IN PROFITS LITERALLY,
AND SOME PEOPLE EVEN WIN NOBEL
PRIZES.
BUT NOTICE THERE ARE OTHER
RESEARCHERS, OTHER COMPANIES
THAT HAVE EQUALLY GOOD IDEAS,
WHICH JUST OUT OF LUCK DIDN'T
PAN OUT.
SOME THINGS WORK, SOME THINGS
DON'T.
WE CAN'T TELL IN ADVANCE WHICH
THINGS WILL AND A WHICH ONES
DON'T.
THAT'S WHY WE JUST HAVE TO DO
THE RESEARCH.
BUT THE PEOPLE WHO HAVE A
PRODUCT OR COMPANY THAT HAS A
PRODUCT THAT DOESN'T PAN OUT,
THEY DON'T EARN PROFITS, ANY
PROFITS, THEY LOSE MONEY, MUCH
LESS EARNING BILLIONS OF DOLLARS
OF PROFITS.
SO THE FACT THAT THERE'S LUCK
HERE SEEMS THAT UNDER CURRENT
PRACTICE, IT'S NOT RELEVANT, SO
IF IT'S NOT RELEVANT TO
RESEARCHERS AND COMPANIES, I
THINK IT'S NOT AND SHOULDN'T BE
CONSIDERED RELEVANT TO WHETHER
DONORS WHO CONTRIBUTE SHOULD
SHARE IN THE PROFITS.
SO HOW DO WE AVOID A STATUS QUO
BIAS?
SO HERE'S MY GENERAL APPROACH,
IS TO -- LET'S THINK ABOUT WHICH
TYPES OF CONTRIBUTIONS UNDER
CURRENT PRACTICE DO LEAD TO A
CLAIM OR DO LEAD TO RECOGNITION
IN WHICH INDIVIDUALS SHOULD
SHARE IN THE PROFITS.
SO FOR INSTANCE, WHY DO THE
CONTRIBUTIONS OF RESEARCHERS
MERIT A SHARE OF THE
CONTRIBUTION -- OF THE PROFITS?
IF WE CAN FIGURE THAT OUT, THEN
WE CAN APPLY THE SAME PRINCIPLE
TO SAMPLE DONORS.
SO WOULD DO RESEARCHERS MERIT
CLAIM IN SOME CASES AND HOW DOES
THAT APPLY, THE ANSWER TO THAT
QUESTION, APPLY TO DONORS?
SO I'M A PHILOSOPHER AS A NUMBER
OF YOU KNOW BUT THE GOOD NEWS
FOR TODAY IS I'M NOT GOING TO GO
INTO IN DEPTH PHILOSOPHICAL
ANALYSIS FOR A SIMPLE REASON, I
DON'T THINK THE CURRENT
PRACTICE, I DON'T THINK IT'S
BASED ON MANY PHILOSOPHICAL
PRINCIPLES.
AND HERE'S HOW PHILOSOPHERS
WOULD TRY TO ANSWER THIS
QUESTION.
WHAT THEY DO IS THEY SAY, OKAY,
WE WANT TO FIGURE OUT HOW TO
DISTRIBUTE THE PROFITS FROM SOME
LINE OF RESEARCH.
LET'S FIGURE OUT THE BEST OR
WHAT PHILOSOPHERS CALL THE IDEAL
APPROACH.
THIS IS SOMETIMES CALLED IDEAL
THEORY.
AND WHAT A PHILOSOPHER DOES,
THEY SAY, OKAY, LET'S IMAGINE
WE'RE STARTING THE WORLD FROM
SCRATCH.
I'M BUILDING A COUNTRY FROM
SCRATCH ON MY OWN.
WHAT PRINCIPLES WOULD I USE,
WHAT PRINCIPLES DO I THINK ARE
THE RIGHT PRINCIPLES TO USE TO
DISTRIBUTE THE BENEFITS AND THE
BURDENS WITHIN THAT COUNTRY OR
WITHIN THAT WORLD.
PHILOSOPHERS GIVE A LOT OF
INTERESTING ANSWERS AND
PRINCIPLES.
ALTHOUGH THERE'S NOT A LOT OF
AGREEMENT, SOME SAY YOU SHOULD
DISTRIBUTE PROFITS AND BENEFITS
IN A WAY THAT HELPS THE PEOPLE
WORST OFF.
OTHER PEOPLE SAY YOU GIVE PEOPLE
WHAT THEY DESERVE.
SO FOR INSTANCE THERE ARE
DIFFERENT VIEWS OF WHO'S WORKED
HARD TO GET THE PROFITS OR WHO'S
A GOOD PERSON MORALLY SHOULD GET
THE PROFITS.
NOW, WHATEVER YOU THINK OF THOSE
PRINCIPLES, I THINK IT'S FAIRLY
CLEAR THAT THEY DON'T GOVERN
CURRENT PRACTICE.
CURRENT PRACTICE DOESN'T FOLLOW
ANY OF THESE PRINCIPLES.
SO HERE'S AN EXAMPLE.
AS WE MENTIONED, SAMPLE DONORS
UNDER CURRENT PRACTICE AND A LOT
OF OTHER PEOPLE INVOLVED IN
RESEARCH, COMPUTER TECHNICIANS,
CLINIC NURSES, AND MANY OTHERS,
AND MAKE IMPORTANT CONTRIBUTIONS
TO STUDIES.
THEY ALSO WORK HARD, I'VE WORKED
AT THE NIH FOR A LONG TIME NOW,
I KNOW HOW HARD THESE PEOPLE
WORK AND A LOT OF THEM, I'VE
FOUND, ARE VERY GOOD PEOPLE, BUT
NONETHELESS, THEY DON'T SHARE IN
THE PROFITS OF THE STUDIES THAT
THEY WORK ON, WHEREAS THE
RESEARCHERS FREQUENTLY DO.
AND WHEN WE DETERMINE WHETHER
RESEARCHERS SHOULD SHARE IN THE
PROFITS, WE DON'T HAVE -- DID
THEY WORK REALLY HARD.
SO WHY IS IT THAT THE
RESEARCHERS SHARE BUT THESE
OTHER PEOPLE DON'T SHARE IN THE
PROFITS?
I THINK THE ANSWER HAS TO DO
WITH THE SPECIFIC TYPE OF
CONTRIBUTION.
SO THE THOUGHT HERE IS THAT
CURRENT PRACTICE DETERMINES WHO
SHOULD SHARE IN THE PROFITS NOT
BY ASKING THIS GENERAL QUESTION,
WHO CONTRIBUTED IN ANY WAY TO
THE DEVELOPMENT OF THE PROFIT?
SO THE COMPUTER TECHNICIAN
CONTRIBUTES, THE CLINIC NURSES
CONTRIBUTE, LOTS OF PEOPLE
CONTRIBUTE BUT THAT'S NOT WHAT
DETERMINES WHO SHARES IN THE
PROFITS.
I SHOULD TELL YOU THAT IN MY
VIEW, I THINK THERE'S A GOOD
ARGUMENT THAT THOSE PEOPLE
SHOULD BUT THAT'S AN ARGUMENT
FOR ANOTHER DAY.
INSTEAD I THINK WHAT CURRENT
PRACTICE IS BASED ON IS ASKING A
MORE SPECIFIC QUESTION.
IT ASKS WHO CONTRIBUTES TO THE
SPECIFIC PROPERTIES WHICH MAKE
THE RESULTING PRODUCT VALUABLE?
SO IMPLEMENTING THIS PRINCIPLE
REQUIRES THAT WE ANSWER TWO
QUESTIONS.
WHICH PROPERTIES MAKE THE
PRODUCT PROFITABLE AND WHO
CONTRIBUTED TO THOSE PROPERTIES.
SO JUST TO GIVE A RELATED
EXAMPLE, HOW DOES THIS WORK IN
THE CASE OF AUTHORSHIP ON
MANUSCRIPTS?
HOW DO WE DECIDE WHO'S AN AUTHOR
ON A MANUSCRIPT, WHICH IS THE
BENEFIT WITHIN ACADEMIA AND
RESEARCH?
WELL, WHAT WE ASK IS WE ASK
HERE'S THE STANDARD, WHO
CONTRIBUTED TO THE IMPORTANT
INTELLECTUAL CONTENT THAT'S
CONTAINED IN THE MANUSCRIPT?
SO THE IDEA IS THAT IT'S THE
IMPORTANT INTELLECTUAL CONTENT
THAT'S THE VALUABLE PROPERTY OF
A MANUSCRIPT, AND WHOEVER
CONTRIBUTED TO THAT PROPERTY
BECOMES AN AUTHOR ON THE
MANUSCRIPT.
SO THAT'S JUST ONE EXAMPLE.
SO HERE'S SOME VERY PROMINENT
COMMENTATORS ON THIS ISSUE.
WHAT THEY ARGUE IS THEY ARGUE
THAT WHAT SAMPLE DONORS DO AND
BY IMPLICATION MANY OTHER
MEMBERS OF THE RESEARCH AND
CLINICAL TEAMS LIKE THE COMPUTER
TECHNICIANS AND THE CLINIC
NURSES, THEY DON'T CONTRIBUTE TO
THE VALUABLE PROPERTY, INSTEAD,
IN THE WORDS OF BOB AND HIS
COLLEAGUES, THEY CONTRIBUTE WHAT
THEY REGARD AS THE RAW MATERIAL.
SO THE SAMPLES THAT CONTRIBUTED,
THE ELECTRICITY THAT GETS
CONTRIBUTED, THE CARE OF THE
PATIENTS, IN A WAY THOSE ARE THE
RAW MATERIALS ON WHICH THE
RESEARCH IS BASED.
THE ARGUMENT HERE IS IN
CONTRAST, WHAT RESEARCHERS DO IS
SOMETHING DIFFERENT.
THEY TAKE THOSE RAW MATERIALS
AND THEY TRANSFORM THEM INTO
SOMETHING VALUABLE, SAY A
VACCINE, A DRUG, AN
INTERVENTION, A NEW SURGICAL
TECHNIQUE, AND THAT IS WHY UNDER
CURRENT PRACTICE, RESEARCHERS
ALSO HAVE A CLAIM TO SHARE IN
THE PROFITS.
THEY CONTRIBUTE TO THE VALUABLE
PROPERTIES OF THE RESULTING
PRODUCT OR INTERVENTION.
SO THE ARGUMENT I WANT TO MAKE
IS FAIRLY STRAIGHTFORWARD.
I WANT TO ACCEPT THAT.
I THINK THAT IS AT LEAST ONE OF
THE IMPORTANT PRINCIPLES THAT
CURRENT PRACTICE USES, BUT I
WANT TO ARGUE THAT THERE ARE
CASES IN WHICH THE DONORS OF
SAMPLES ACTUALLY CONTRIBUTE TO
THE VALUABLE PROPERTIES OF THE
RESULTING PRODUCTS.
IN PARTICULAR, THERE ARE CASES
WHERE WHAT THE RESEARCHES DO IS
THEY DON'T CREATE THE VALUABLE
PROPERTIES.
INSTEAD THE VALUABLE PROPERTIES
ARE PRESENT IN THE DONATED
SAMPLE AND THE RESEARCHES -- IN
THESE CASES THE DONORS, THROUGH
THEIR CONTRIBUTION OF THEIR
SAMPLES, DO, I THINK, CONTRIBUTE
TO THE VALUABLE PROPERTIES OF
THE FINAL PRODUCTS AND THEN
ACCORDING TO THIS PRINCIPLE,
THESE DONORS SHOULD SHARE IN THE
PROFITS AS WELL.
SO THE ANSWER TO OUR QUESTION,
THEN, AT LEAST SOME DONORS, I
THINK, UNDER CURRENT PRACTICE,
SHOULD SHARE IN THE PROFITS.
SO JUST SOME EXAMPLES COMING
BACK TO HENRIETTA LACKS THAT I
MENTIONED IT THE BEGINNING,
THEY'RE CALLED HELA CELLS, WHY
THEY'VE BECOME SO INCREDIBLY
IMPORTANT TO SCIENTISTS IS
BECAUSE THOSE CELLS TAKEN FROM
HENRIETTA LACKS HAVE AN
INCREDIBLE CAPACITY TO SURVIVE,
THAT THE RESEARCHERS NEVER
HAVING SEEN IN THE HISTORY OF
THEIR CAREERS BEFORE.
THAT WAS A CAPACITY THE
RESEARCHERS DIDN'T CREATE.
IT WAS PRESENT IN THE CELLS THAT
WERE TAKEN FROM HENRIETTA LACKS.
TO GIVE YOU ANOTHER EXAMPLE,
THERE ARE PEOPLE CALLED LONG
TERM NON-PROGRESSORS,
INDIVIDUALS WHO HAVE HIV FOR
DECADES, THEY DON'T GET ANY
TREATMENT AND NONETHELESS, THEY
DON'T GET SICK, THEY DON'T EVEN
GET SYMPTOMATIC, AND THE REASON
IS THAT THEIR IMMUNE SYSTEM IS
DOING SOMETHING THAT THE IMMUNE
SYSTEM OF THE AVERAGE PERSON
DOESN'T DO, MAINLY, IT FIGHTS
OFF HIV.
SO WHAT RESEARCHERS ARE DOING IS
SOMETHING CLEVER.
THEY GET CELLS FROM THOSE
INDIVIDUALS AND THEN THEY ASK
THEMSELVES, OKAY, WHAT'S GOING
ON IN THE IMMUNE CELLS OF THESE
INDIVIDUALS THAT'S FIGHTING OFF
HIV.
IF WE CAN IDENTIFY THAT AND TAKE
ADVANTAGE OF IT, WE CAN THEN
DEVELOP VACCINES AND TREATMENTS
FOR HIV.
SO THAT'S A REALLY WONDERFUL
IDEA.
IF IT SUCCEEDS, WE'RE GOING TO
HAVE GREAT TREATMENTS THAT COULD
BE VERY PROFITABLE, AND THOSE
CASES, AGAIN, THOSE INDIVIDUALS
GIVEN THE CAPACITY OF THEIR
CELLS CONTRIBUTE TO PROFITS.
IF THE RESEARCHERS DO -- IT
TURNS OUT WE'LL NEVER KNOW, IF
IT TURNS OUT THOSE PROPERTIES
MAKE THOSE CELLS -- AND IF
RESEARCHERS ARE ABLE TO
TRANSFORM THOSE PROPERTIES INTO
A VACCINE THAT'S SUCCESSFUL AND
MAKES A LOT OF PROFITS, THEN I
THINK THAT RESEARCHER DOES HAVE
SOME CLAIM TO SHARE IN THE
PROFITS THAT RESULT.
SO IN SUMMARY, UNDER CURRENT
PRACTICE, INDIVIDUALS WHO
CONTRIBUTE TO THE VALUABLE
PROPERTY OF RESULTING PROFITS,
THOSE ARE THE ONES WHO SHARE IN
THE PROFITS AND I'M -- IN SOME
CASES THIS PRINCIPLE SUGGESTS
THAT SAMPLE DONORS SHOULD AS
WELL.
THERE ARE LOTS OF QUESTIONS HERE
I'M NOT GOING TO BE ABLE TO GET
TO, HOW BIG OF A SHARE, HOW DOES
THE SIZE OF THE SHARE OF DONORS
COMPARE TO RESEARCHERS,
INVESTORS, THE COMPANY, LOTS OF
OTHER PEOPLE?
I DON'T KNOW.
THE ANSWERS TO
THOSE QUESTIONS.
THOSE ARE THINGS WE'RE GOING TO
HAVE TO FIGURE OUT IN FUTURE
RESEARCH.
THANK YOU.
>>IT'S A REAL THRILL TO BE HERE
WITH EVERYBODY.
THANK YOU FOR HAVING ME.
I DON'T HAVE ANY SLIDES, YOU'RE
GOING TO HAVE TO STARE AT ME
UNFORTUNATELY OR FORTUNATELY,
YOU CAN DECIDE.
START WITH DISCLOSURES.
I'VE SERVED AS A CONSULTANT
FOR -- FARM SE FA PHARMACEUTICAE
ARE ALL IN THE PAST.
I CURRENTLY SIT ON THE ADVISORY
BOARD -- THE VIEWS EXPRESSED ARE
MINE ALONE.
SO I WANT TO START TO JUST
CLEARLY STAKEOUT IN TERMS OF THE
QUESTIONS WE'RE ASKING.
FIRST IS A LEGAL MATTER, I DON'T
THINK ANYBODY IS SUGGESTING THAT
ANYTHING IN THE LAW OR THE RULE
OUR MAIN RESEARCH REGULATION
TOOL IN THE UNITED STATES
REQUIRES PROFIT SHARING.
SO WE'RE REALLY NOT IN THE LEGAL
REGULATORY BUCKET AT THE MOMENT,
THE ETHICAL QUESTION, WOULD IT
BE GOOD TO REVISE THESE OR WOULD
IT BE GOOD ETHICALLY TO HAVE
PROFIT SHARING FOR PARTICIPANTS?
OTHERWISE PUT, IF YOU'RE UP
FRONT IN YOUR INFORMED CONSENT
CURRENTLY ABOUT THAT YOU'RE NOT
GOING TO PROFIT-SHARE, IT'S HARD
TO SEE HOW YOU RUN INTO A
PROBLEM.
WE'RE REALLY TALKING ABOUT
REVISION.
THE SECOND POINT OF
CLARIFICATION IS JUST TO SAY, I
THINK WE'RE TALKING ABOUT A
REQUIREMENT NOT A PREROGATIVE.
SO WHAT DO I MEAN BY THAT?
I DON'T THINK MY POSITION IS
THAT SUCH PROFIT SHARING SHOULD
BE IMPERMISSIBLE, THOUGH I'LL
GESTURE SOME REASONS WHY WE
THINK IT MIGHT BE AN AREA OF
CONCERN IN SOME CASES.
INSTEAD I THINK THE ISSUE THAT
DR. WENDLER SO NICELY TEED UP IS
WHETHER IT SHOULD BE REQUIRED
AND UNDER WHAT CONDITION.
SO IF I'M RIGHT, WE'RE TALKING
ABOUT ETHICS, NOT LAW OR
REGULATION, AND WE'RE TALKING
ABOUT WHAT'S ETHICALLY REQUIRED
OR NOT.
NOW BACK TO THE STARTING CASE
THAT DR. COHEN PRESENTED TO US.
IT'S A WONDERFULLY UNUSUAL CASE
AND JUST TO AGE MYSELF, I'M
GOING TO REFERENCE A FAMOUS
1980s COMMERCIAL FOR THE HAIR
CLUB FOR MEN WHERE THEY'RE
SELLING YOU ON THIS THING TO
RE-GROW YOUR HAIR OR A WIG, I
CAN'T QUITE REMEMBER, AND THE
GUY SAYS AT THE END, I'M NOT
JUST THE PRESIDENT, I'M ALSO A
CLIENT!
AND WHAT I LOVE ABOUT THIS CASE
IS WE HAVE A SIMILAR KIND OF
RELATIONSHIP HERE.
I'M NOT JUST THE P.I., BUT I'M
ALSO A RESEARCH PARTICIPANT.
AND ACTUALLY, IT FLAGS SOME VERY
INTERESTING QUESTIONS ON
SELF-EX-PAIR MENTATION, ITS
HISTORY THAT'S NOT OUR TOPIC
TODAY BUT I JUST WANT TO GESTURE
AT THAT.
BUT WHAT'S SO NICE ABOUT IT AS A
CASE STUDY IS IT REALLY NICELY
ILLUSTRATES THE PUZZLE THAT
DR. WENDLER SUGGESTED.
THE P.I. WILL BE COMPENSATED FOR
HIS WORK AS A SCIENTIST, AS A
P.I., BY PROFIT SHARING.
WHY SHOULD HE NOT ALSO BE
COMPENSATED FOR HIS,
QUOTE-UNQUOTE, WORK AS A
RESEARCH PARTICIPANT.
BUT IF HE SHOULD BE, WHY
SHOULDN'T ALL OTHER,
QUOTE-UNQUOTE, WOARKERS, WORKES
EVERY RESEARCH PARTICIPANT ALSO
BE COMPENSATED?
BUT IN FACT, SHOULD PARTICIPANTS
BE COMPENSATED IS NOT QUITE THE
QUESTION RAISED BY THE CASE.
THE QUESTION IS NOT DO RESEARCH
PARTICIPANTS DESERVE
COMPENSATION.
BUT INSTEAD, TO BORROW THE
LANGUAGE FROM DR. COHEN'S SLIDE,
SHOULD THEY, QUOTE, SHARE IN THE
PROFITS OF STUDIES TO WHICH THEY
CONTRIBUTE?
IT'S COMMONPLACE FOR
PARTICIPANTS TO BE PAID FOR
PARTICIPATION IN VARIOUS TRIALS.
THERE'S LOTS OF INTERESTING
QUESTIONS ABOUT EXACTLY WHAT
COMPENSATION, IS THERE UNDUE
INDUCEMENT, ET CETERA.
BUT ORDINARILY, THAT
COMPENSATION DOES NOT TAKE THE
FORM OF A PIECE OF THE ACTION,
IF YOU WILL.
THUS THE QUESTION TEED UP IS
REALLY NOW CLARIFIED, WHY SHOULD
THE P.I. BE COMPENSATED THROUGH
A SHARE IN THE PROFITS OF
STUDIES TO WHICH HE CONTRIBUTES,
BUT RESEARCH PARTICIPANTS ONLY
COMPENSATED THROUGH OTHER MEANS,
MEANS OTHER THAN PROFIT SHARING?
SO WHEN YOU PUT IT THIS WAY, I
THINK IT'S NOT QUITE AS PUZZLING
AS IT STARTS OUT WHEN YOU DON'T
PUT IT THIS WAY.
TO SEE WHY, FIRST RECOGNIZE THE
WORLD IS NOT BISECTED BETWEEN
THE P.I. AND RESEARCH STAFF ON
ONE HAND AND THE PARTICIPANTS IN
THE OTHER.
IN THAT MOST OF THE RESEARCH
STAFF AS DR. WENDLER SUGGESTED
ARE ALSO NOT GIVEN PROFIT
SHARING.
MOST STUDY COORDINATORS, MOST
FOLKS WHO ARE EMPLOYED IN
RESEARCH DON'T GET PROFIT
SHARING.
INSTEAD, THEY'RE COMPENSATED BY
SALARY.
AND INDEED, THIS IS NOT UNUSUAL
OUTSIDE RESEARCH.
IF WE LOOK AT LARGE
CORPORATIONS, WHILE C-SUITE
EXECUTIVES ARE OFTEN COMPENSATED
WITH PROFIT SHARING, MOST OF THE
PEOPLE WHO ARE PART OF A
CORPORATION ARE PAID ON SALARY.
SO WE MIGHT REFRAME THE QUESTION
IS WHY WE HAVE PROFIT SHARING AT
ALL?
ONE ANSWER THE LAW AND ECONOMIC
TYPES WOULD LIKE, I THINK, IS
THE QUESTION OF PRINCIPAL AGE
INTENTION AND THE ALIGNING OF
INCENTIVES.
WE GIVE INDIVIDUALS A SHARE OF
THE PROFITS RATHER THAN FLAT
COMPENSATION WHEN IT WILL CAUSE
THEM TO PURSUE BEHAVIOR IN A WAY
THAT IS WELL ALIGNED WITH OUR
GOAL, EITHER OUR PRIVATE GOAL OR
A SOCIAL GOAL.
IN THE CASE OF THE CEO, THE
PROFIT SHARING IS ARGUED TO
ALIGN BETTER WITH SHAREHOLDERS
AND THEIR INTERESTS, IN A WAY
OF -- CEO BEHAVIOR.
THERE'S AN IDEA OF SKIN IN THE
GAME, IF YOU WILL.
SIMILARLY WHEN YOU'RE A REALTOR,
IF YOU'VE SOLD A HOUSE, IT'S A
PERCENTAGE OF THE SALE PRICE,
ARGUABLY THAT'S MEANT TO DO THE
SAME THING, TO ALIGN THE
INCENTIVE OF THE REALTOR WITH
YOU, THE PERSON WHO'S HIRED
THEM.
ALL THESE, THOUGH, ASSUME THE
FORM OF COMPENSATION WILL
ACTUALLY ALTER BEHAVIOR.
THAT IS, IF WE GIVE SOMEONE
PROFIT SHARING, WE GET A
DIFFERENT KIND OF BEHAVIOR THAN
IF WE DON'T.
THAT RAISES THE QUESTION ABOUT
WHETHER BEHAVIORAL ALTERATIONS
FORMED BY PROFIT SHARING ARE
DESIRABLE.
NOW WE IMMEDIATELY SEE WHEN WE
FRAME IT THIS WAY SOME WORRIES
ABOUT PROFIT SHARING WITH SOME
RESEARCH STAFF MEMBERS.
AND THERE'S SOME RESEARCH ETHICS
LITERATURE RELATED TO ROW
KREUTMENT BONUSES AND BALLOON
PAYMENTS THAT I THINK KIND OF
REFERENCE THIS.
IF AS A RESEARCH STAFF MEMBER
YOUR COMPENSATION DEPENDS ON
WHETHER THE TRIAL DOES OR DOES
NOT RECRUIT X NUMBER OF PATIENTS
BY WIDE DATE, THAT CREATES AN
INCENTIVE TO RECRUIT MORE
PATIENTS.
THAT INCENTIVE MAY OR MAY NOT
LEAD YOU TO BEHAVIOR THAT NOW
MISALIGNS YOU WITH THE BEST
INTEREST OF PARTICIPANTS, EITHER
INTENTIONALLY OR LESS SO.
FOR EXAMPLE, MAYBE YOU HAVE AN
INCENTIVE TO SCRIMP OUR DOWNPLAY
ON RISK RELATED TO INFORMED
CONSENT TO MEET YOUR TARGET.
SO WE ACTUALLY HAVE AN INCENTIVE
THAT'S NOT ALIGNING WELL WITH
WHAT WE WANT TO ACHIEVE.
WHAT THE ALIGNMENT INCENTIVE TO
ALTER THE BEHAVIOR OF RESEARCH
PARTICIPANTS IF THEY GET A
PROFIT SHARE?
SO LET'S TAKE THE TISSUE SAMPLE
CASE, EITHER DR. COHEN'S OR THE
HELA CASE.
NOTICE ONE YOU'VE GIVEN YOUR
SAMPLE, THE ABILITY TO STEER THE
ENTERPRISE TOWARDS PROFIT OR NOT
IS OVER.
THERE'S ACTUALLY NO BEHAVIOR TO
INCENTIVIZE.
PROFIT SHARING BY DEFINITION CAN
ALIGN YOUR BEHAVIOR WITH THE
SOCIAL OR PRIVATE GOAL BECAUSE
THERE'S NO BEHAVIOR TO
INCENTIVIZE POST PROVISION OF
TISSUE.
SO IF ANYTHING, TISSUE SAMPLES
IS A PARTICULARLY WEAK SETTING
FOR AN ARGUMENT THAT PROFIT
SHARING ISN'T REQUIRED AS A WAY
TO ALIGN INCENTIVE.
NOW TRIALS THAT REQUIRE EFFORT
FROM PARTICIPANTS MIGHT BE MORE
APPROPRIATE SETTINGS FOR PROFIT
SHARING BUT AGAIN YOU MIGHT
WORRY THAT THE PROFIT SHARING
MIGHT SKEW BEHAVIOR IN A WAY
THAT MAKES THE TRIAL LESS GOOD.
OR MAKES THE EVIDENCE GENERATED
LESS EEK LOGICALLY VALID AS TO
END STATE PATIENTS IF THOSE SAME
INCENTIVES WON'T PERSIST FOR THE
POPULATION POST TRIAL.
AT BEST, IT SEEMS TO ME PROFIT
SHARING COULD BE JUSTIFIED BY --
RECRUITMENT FOR THE TRIAL BUT
THEN THE ETHICAL OOMPH FOR DOING
IT WOULD BE FROM THE ETHICAL
IMPERATIVE TO RECRUIT TO
COMPLETION OR RECRUIT MORE
IMIKLY, NOT FROM THE PROFIT
SHARING AS SUCH.
AS COMPARED TO OTHER FORMS OF
INCENTIVES YOU MIGHT GIVE TO
ACHIEVE THE SAME THING, PROFIT
SHARING MIGHT BE PARTICULARLY
BAD.
WHY DO I SAY THAT?
WELL, I DON'T THINK SUCH PROFIT
SHARING FOR PATIENTS WOULD BE
PER SE IMPERMISSIBLE, I DO WANT
TO ACKNOWLEDGE THAT THERE MAY BE
SOME WHO PARTWAYS FROM BEYOND
THIS BECAUSE THEY'RE WORRIED
ABOUT UNDUE INDUCEMENT AND IN
SOME INSTANCES, PROFIT SHARING
MAY PRODUCE A LEVEL OF
COMPENSATION THAT WE COULD VIEW
AS UNDUE INDUCEMENT.
I'LL ALSO ADD AS A PRACTICAL
MATTER, UNLIKE REVIEWING A FLAT
COMPENSATION FOR A CHALLENGE
TRIAL OR OTHER KIND OF TRIAL, AN
INSTITUTIONAL REVIEW BOARD MAY
AT TIME OF APPROVAL MAY HAVE A
HARD TIME FIGURING OUT WHAT THE
COMPENSATION OF A PROFIT SHARING
RANGE MAY ACTUALLY BE BECAUSE
THE DRUG HASN'T GONE TO MARKET,
WE DON'T KNOW IF IT'S GOING TO
BE SUCCESSFUL.
SUCH THAT IF WE'RE WORRIED ABOUT
UNDUE INDUCEMENT, THE IRB MAY
NOT KNOW WHAT THE LEVEL OF
INDUCEMENT IS BY OFFERING PROFIT
SHARING UNLESS WE OFFER SOME
KIND OF STEALING AND THAT'S A
LITTLE BIT OF THE INTENTION WITH
PROFIT SHARING MOTIVES TO BEGIN
WITH.
THERE ARE ALSO SOME THAT MIGHT
WORRY THAT RESEARCH PARTICIPANTS
PROMISED PROFIT SHARING MAY HAVE
UNREALISTIC EXPECTATIONS ABOUT
HOW MUCH PROFIT THE PRODUCT WILL
MAKE AND HOW MUCH REVENUE WILL
ULTIMATELY FLOW TO THEM, AND
IT'S A PROBLEM FOR PATIENTS TO
AGREE TO THIS ON SUCH
UNREALISTIC OR DATA-WEAK FORMS
OF INFORMATION.
AGAIN I'M NOT PARTICULARLY MOVED
BY CONCERNS ABOUT JUSTIFIED
PATERNALISM HERE, EXCEPT PERHAPS
IN VERY HIGH RISK SETTINGS, BUT
OTHERS MIGHT BE.
FINALLY ONE MIGHT BE WORRIED
ABOUT TRANSACTION COSTS WITH
PATIENT LEVEL CONTRACTING OVER
PROFIT SHARE OVER HOLD CHOWTS
AND THICKETS THAT EVERYBODY
OWES -- MAKES THE VALUE OF THEIR
CONTRIBUTION AND THE COST OF
INDIVIDUALLY CONTRACTING IS
HUGE, AND IT ALSO MAY GENERATE
INEQUITABLE RESULT IF DIFFERENT
PARTICIPANTS GET DIFFERENT
AMOUNTS BASED ON THE VALUATION
OF THEIR OWN CELLS.
ALL RIGHT.
SO I'M ALMOST DONE ON THIS SET
OF POINTS BUT BEFORE PIVOTING, I
JUST WANT TO OBSERVE THAT IF
ANYBODY I HAVE SAID SO FAR HAS
RESONATED WITH YOU, THIS WEIRDLY
LEADS US TO FLIP THE PROBLEM ON
ITS HEAD.
THE DILEMMA OFFERED BY
DR. WENDLER HAS CORRECTLY
IDENTIFIED SOMETHING DIFFERENT
BETWEEN PARTICIPANTS AND THE
P.I., BUT INSTEAD OF
RECOMMENDING LEVELING UP
EVERYBODY TO PROFIT SHARING,
THAT IS, TO BRING PARTICIPANTS
TO PROFIT SHARING, IF ANYTHING
MAYBE MAKES YOU THINK WE SHOULD
BE LEVELING DOWN THE P.I.s TO
GIVE THEM FLAT COMPENSATION
RATHER THAN PROFIT SHARING, THAT
IS, IF WE CONCLUDE PROFIT
SHARING FAILS TO CORRECTLY ALIGN
INCENTIVES OF WHAT'S SOCIALLY
OPTIMAL FOR PARTICIPANTS, WHY
ARE WE SO SURE CORRECTLY ALIGNS
INCENTIVE WHEN IS IT COMES TO
PIs?
OKAY.
SO EVERYTHING I'VE SAID SO FAR,
I'VE APPROACHED THIS PROBLEM
THROUGH A SET OF VIEWS THAT IF
NOT CONTRARY TO HOW DR. WENDLER
HAS FRAMED IT, ARE I WOULD SAY
PRETTY O ORTHOGONAL TO HIS
FRAMING.
I HAVE TREATED PROFIT SHARING
FOR PARTICIPANTS AS A TOOL FOR
PRODUCING SOCIALLY BENEFICIAL
OUTCOMES AND QUESTION WHETHER IT
DOES SO, AND WHETHER IT HAS A
SET OF NEGATIVE CONSEQUENCES
THAT OTHER FORMS OF INCENTIVES
LIKE COMPENSATION IN A FLAT
STRUCTURE MIGHT NOT.
THAT'S KIND OF A BROADLY
CONSEQUENTIALIST APPROACH TO THE
PROBLEM.
DR. WENDLER, THOUGH, HAS
APPROACHED THE QUESTION AS ONE
OF DESSERT, NOT INCENTIVES.
AND THE ALIGNMENT PRINCIPLE --
ON MY VIEW.
THAT IS THE FRAMING OF THE
PROBLEM IS THAT PARTICIPANTS
DESERVE A PIECE OF THE ACTION
AND IT'S A SORT OF MORAL WRONG
TO DENY THEM THAT PIECE OF THE
ACTION.
SO HE NOTES, FOR EXAMPLE, TO USE
A CASE I WANT TO RETURN TO THAT,
QUO, HELA CELLS HAVE AN
INCRESTIBLE CAPACITY TO SURVIVE.
RESEARCHERS DID NOT CREATE THIS
CAPACITY, THEY TOOK ADVANTAGE OF
IT.
UNQUOTE.
ONE WAY OUT OF THIS COMPARISON
IS TO SAY THAT ACTUALLY NOBODY
DESERVES PROFIT SHARING.
SO HE'S OFFERED AN ARGUMENT
AGAINST RESEARCHER PROFIT
SHARING NOT AN ARGUMENT FOR
PATIENT PROFIT SHARING.
THAT WOULD BE A WAY TO KIND OF
CHARACTERIZE WHAT HE'S OFFERED
US.
I WANT TO DRAW A DISTINCTION,
THOUGH, BETWEEN DESSERT
CONNECTED TO EFFORT VERSUS
DESSERT CONNECTED TO MORAL LUCK.
TO SHOW YOU WHILE I DON'T THINK
THE DESSERT ARGUMENT JUSTIFIES
TISSUE PROVIDER PROFIT SHARING,
CONSIDER THE FOLLOWING
HYPOTHETICAL BASED ON THE REAL
CASE OF HENRIETTA LACKS.
IN THE ROOM NEXT TO HENRIETTA
LACKS IS ANOTHER BLACK WOMAN,
HERMIONE UNLUCKY.
SHE'S EXACTLY LIKE HENRIETTA.
SHE TOO HAS TISSUE TAKEN FROM
HER TUMOR.
AS A BLACK WOMAN WITH CERVICAL
CANCER GETTING CARE AT HOPKINS
AT THE TIME, SHE, TOO, IS
TREATED IN A WAY THAT WE VIEW
BAD, AS BAD FROM OUR VANTAGE
POINT IN TERMS OF HER SUPPORT
FRFROM THE HEALTHCARE SYSTEM WHN
WE LOOK BACK NOW.
THE ONLY DIFFERENCE, IN FACT,
BETWEEN HER AND HENRIETTA IS
THAT HER CELLS ARE JUST
ORDINARY.
BECAUSE HER PROFIT SHARING --
CONTRIBUTION, IT REQUIRES WE
TREAT THEIR SHARES DIFFERENTLY.
DR. WENDLER'S CLAIM, I THINK,
REQUIRES US TO SAY THAT
HENRIETTA DESERVES SOMETHING
THAT HERMIONE DOESN'T.
THIS IS TRUE PRESUMABLY EVEN IF
HERMIONE IS A NORMAL CONTROL IN
THE STUDY, SOMEBODY WITHOUT WHOM
THE STUDY ALSO COULD NOT TAKE
PLACE, SHE JUST DOESN'T HAVE
THESE SPECIAL CELLS.
SO THE CLAIM IS, HENRIETTA'S
CELLS ARE SPECIAL, SO HENRIETTA
DESERVES COMPENSATION FOR THAT.
HERMIONE'S ARE NOT SPECIAL SO
SHE DESERVES NO COMPENSATION OR
LESS COMPENSATION FOR THAT
REASON.
THE PROBLEM, THOUGH, IS IT'S A
MAKER IT OF PURE MORAL LUCK THAT
HENRIETTA'S CELLS ARE SPECIAL
AND HERMIONE'S AREN'T.
EACH HAS THE EXACT SAME
ENCOUNTER WITH THE MEDICAL
SYSTEM AND ACT IN EXACTLY THE
SAME WAY.
SHEER MORAL LUCK IN THEIR
GENETICS.
THAT DOES CHANGE HOW OUR LIVES
GO EVEN JUST IN THE NARROW SPACE
OF COMPENSATION.
MICHAEL JORDAN OR MICHAEL PHELPS
CAN MAKE CLAIMS TO ATHLETIC
PERFORMANCE THAT I, GLENN COHEN,
CANNOT, AND ARE COMPENSATED FOR
IT EVEN THOUGH IT IS A RESULT AT
LEAST IN PART OF THEIR MORAL
LUCK AND THEIR GOOD GENETICS.
THAT IS TO SAY, IT IS A
NECESSARY CONDITION FOR THEIR
SUCCESS.
SO WHAT'S DIFFERENT FROM
HENRIETTA LACKS?
I WANT TO SUGGEST IT TRACES
BACK, BELIEVE IT OR NOT, TO JOB
LUCK AND ONE'S THEORY OF
PROPERTY AND ONE'S THEORY OF
COMPENSATION.
LUCK HAS A STARTING POINT OF
SELF-OWNERSHIP THAT MY BODY IS
MY PROPERTY.
THIS IS WHERE HE STARTS, THAT
EVERY MAN HAS A PROPERTY IN HIS
OWN PERSON AS HE PUTS IT.
FROM THIS, HE DERIVES THIS
THEORY THAT AN INDIVIDUAL CAN
ALSO CLAIM PROPERTY IN WHATEVER
THE INDIVIDUAL MIXES HIS OTHER
HER LABOR WITH.
THERE'S SOME NOTION OF SWEAT OF
THE BROW, AS HE PUTS IT.
WE DESERVE PROPERTY IN THAT IN
WHICH WE MIX OUR BODIES.
BUT IN DR. COHEN'S CASE, AND THE
HELA CASE, IT'S THE PRODUCT OF
OUR BODY SEPARATED FROM IT, NOT
THE BODY ITSELF FOR THE MIXING
OF OUR LABOR THAT'S DOING THE
WORK.
THE EFFORT PIECE, THE PROCESS OF
SEPARATING THE TISSUE FROM OUR
CELLS, THE REMOVAL AND THE COST
OF THAT REMOVAL TO US IS EXACTLY
THE SAME FOR HENRIETTA AND FOR
HERMIONE.
THAT IS TO SAY ONE MIGHT ARGUE
FOR EQUAL PAY FOR EQUAL WORK,
AND HENRIETTA AND HERMIONE'S
WORK IS EXACTLY EQUAL.
SO IF THE DIFFERENCE IN
COMPENSATION IS OWED, IT MUST
NOT BE RELATED TO THEIR EFFORT
OR WORK BUT THROUGH THE MORAL
LUCK OF MERE GENETIC
DIFFERENCES, AND THAT'S A MUCH
LESS ATTRACTIVE ARGUMENT FOR
DESSERT.
THE PROBLEM IS ALSO EVIDENT IF
YOU FRAME IT IN MORE ECONOMIC
RATHER THAN MORAL TERMS AS
PEOPLE OFTEN DO WITH
INTELLECTUAL PROPERTY.
USING THE ENTITLEMENT AS
ECONOMIC INCENTIVE TO GET
PRODUCTIVE LABOR.
SO UNLIKE WITH GIVING A NOVELIST
COPYRIGHT IN A NOVEL, FOR
EXAMPLE, THERE DOES NOT SEEM TO
BE MUCH PRODUCTIVE LABOR TO
INCENTIVIZE IN THE INSTANCE OF
GIVING THEIR TISSUE.
MY GENETIC CODE IS WHAT IT IS,
AND NO AMOUNT OF INCENTIVE YOU
OFFER ME WILL MAKE IT CHANGE.
THAT IS TO SAY, IF MY CELLS ARE
ORDINARY, THEY'RE ORDINARY NO
MATTER WHAT EFFORT I PUT IN,
JUST WISHING THER WERE
OTHERWISE.
WHAT IS NEEDED IS AN INCENTIVE
TO SHARE IT WITH YOU, THE
SEPARATION, BUT HERE AGAIN,
HERMIONE AND HENRIETTA ARE
EXACTLY PARALLEL.
THE WORK IS THE SAME.
THUS THE STRONGEST ARGUMENT FOR
PAYING HENRIETTA MORE IS SHE
KNOWS IT'S MORE VALUABLE, AND WE
NEED TO PAY HER MORE TO PART
WITH IT.
BUT THAT'S NOT REALLY AN
ARGUMENT ABOUT DESSERT.
INSTEAD, THAT'S JUST BRINGING US
BACK TO INCENTIVES AND BACK TO
ALIGNMENT, WHICH IS WHERE I
STARTED.
MOREOVER, THE FACTS MAY VARY BUT
MOST PEOPLE DON'T KNOW WHAT IS
OR IS NOT VALUABLE ABOUT THEIR
CELLS, AND THE MORE WE TELL THEM
TO HELP THEM FIGURE IT OUT, THE
MORE WE'RE GOING TO GET
NEGOTIATION AND HOLDOUT PROBLEMS
AND ARGUABLY WE'RE GOING TO
STYMIE HEALTH PRODUCTIVE
RESEARCH.
SO I WANT TO ONCE AGAIN SUGGEST
DR. WENDLER'S CLAIMS ARE MUCH
MORE ON ATTACK ON WHETHER PIs
SHOULD HAVE A RIGHT TO PROFIT
THAN WHETHER PATIENTS SHOULD.
AND HERE I THINK THE ANSWER IS
THAT THE MIXING OF LABOR, THE
INCENTIVE STORY EXPLAINS WHY
PIs ARE OFFERED A CLAIM TO
SHARE IN PROFITS.
THE ARGUMENT IS, WITHOUT PROFIT
SHARING, THEY'RE NOT COMPENSATED
ENOUGH FOR THEIR LABOR, AND THE
RESULT IS THEY'RE NOT GOING TO
SPEND ENOUGH TIME, VOLITION AND
INTELLECTUAL CAPITAL AND WE
DON'T GET TO PRODUCE THE
SOCIALLY VALUABLE STUFF WE WANT.
NOW THAT IS AN EMPIRICALLY
CONTESTABLE PROPOSITION.
IT'S KIND OF A JUST-SO STORY,
AND PERHAPS OUR INNOVATION
ECOSYSTEM WOULD BE BETTER
WITHOUT PROFIT SHARING
INCENTIVES FOR PI.
BUT THEY MAKE THE PI AT LEAST ON
PAR WITH THE NOVELIST, THE
INVENTOR OF A BICYCLE, AND MANY
OTHERS FOR WHOM OUR INTELLECTUAL
PROPERTY SYSTEM HAS DECIDED TO
REWARD THEM RECOMPENSE IN
RELATION TO HOW MUCH PROFIT IS
MADE.
HOPEFULLY I'VE AT LEAST PROVOKED
YOU AND I'M VERY CURIOUS TO HEAR
WHAT MY COLLEAGUES AND ALL OF
YOU HAVE TO SAY.
THANK YOU VERY MUCH.
>>THANKS, GLENN.
WE REALLY APPRECIATE IT AND WE
ALREADY HAVE SOME GREAT
QUESTIONS.
I SUSPECT THAT WE COULD SPEND
THE REST OF OUR CAREERS ON THIS,
MUCH LESS THE NEXT 15 MINUTES OR
SO.
SO THE FIRST ONE, I THINK FOR
BOTH OF US, BUT MAYBE I'LL ASK
YOU BECAUSE YOU'VE TALKED MORE
ABOUT THE INCENTIVE STRUCTURES
THAN I DID, WHICH IS THAT SOME
PEOPLE POINT OUT THAT SHARING
PROFITS WITH CERTAIN PEOPLE, THE
COMPANY, THE RESEARCHERS, THAT
CAN INCENTIVIZE THEM TO DOING
THINGS WE WANT, LIKE CREATING
NEW TREATMENTS, CURES,
SUCCESSFUL VACCINES, BUT IT CAN
ALSO INCENTIVIZE THEM TO DO
THINGS WE EMPHATICALLY DON'T
WANT THEM TO DO, LIKE HIDE THE
FACT THAT SOMEBODY GOT REALLY
SICK ON A DRUG OR SOMEBODY DIED
ON A DRUG OR PEOPLE'S BLOOD
PRESSURE WENT WAY UP IN A WAY
THAT WAS DANGEROUS, AND IF WE
GIVE THEM HUGE INCENTIVES, THEY
HAVE AN INCENTIVE TO HIDE THAT
INFORMATION.
SO ANY THOUGHTS ON HOW THAT
COULD POSSIBLY WASH OUT IN THE
END TO WHETHER OR NOT -- SO I
THINK THE SUGGESTION, AT LEAST
THE QUESTION I HAD WAS -- ALL
THE WAY DOWN ON EVERYBODY --
WHAT YOUR THOUGHTS ARE ON THAT
POSSIBILITY.
>>SO HERE'S A COUPLE OF
REACTIONS.
THE FIRST ONE IS JUST TO SAY
THAT YOU MIGHT THINK THAT
ACTUALLY THIS IS AN ARGUMENT IF
YOU'RE GOING TO PROFIT SHARING
FOR ANYBODY THAT MAYBE THE
PATIENTS OR PARTICIPANTS ARE
BETTER THAN THE INVESTIGATORS
BECAUSE THE PARTICIPANTS CAN DO
LESS MONKEYING AROUND AND LESS
KIND OF NEGATIVE THINGS.
AND THAT'S NOT ALWAYS TRUE,
THERE ARE TRIALS, FOR EXAMPLE,
THAT HAVE A LOT OF SELF-REPORT,
FOR EXAMPLE, INCLUDING ADHERENCE
TRIALS AND THE LIKE WHERE YOU
MIGHT WORRY THAT ACTUALLY THE
INCENTIVE STRUCTURE IS GOING TO
PRODUCE BAD BEHAVIOR.
WHAT I WANT TO SUGGEST IS THAT
THIS FRAMING, WHICH IS TO SAY
HERE WE HAVE A SOCIAL GOAL OR
PRIVATE OR PUBLIC GOAL AND WE
WANT TO KNOW WHAT FORM OF
COMPENSATION IS GOING TO BEST
GET US THERE.
IT'S JUST VERY DIFFERENT FROM
THE FRAMING, WHAT DO PEOPLE
DESERVE?
SO YOU COULD BELIEVE THAT
ACTUALLY THE PIs POORTS PANTS
DON'T DESERVE THE COMPENSATION
BUT WE'RE GOING TO GIVE TO THEM
ANYWAYS BECAUSE WEAR GOING TO
GIVE PEOPLE THINGS THEY DON'T
DESERVE IN ORDER TO SERVE A
GREATER GOAL.
THAT'S QUITE DIFFERENT FROM A
VIEW THAT SAYS, WHEN WE THINK
ABOUT THIS PROBLEM, WE SHOULD
START WITH DESSERT, AND GIVE
PEOPLE WHAT THEY DESERVE, AND
MAYBE THEN ON THE BACK END,
MONKEY A LITTLE AROUND WITH THE
INCENTIVES.
SO I THINK THIS IS WHY I LOVED
YOUR PRESENTATION, DR. WENDLER,
IS THAT I THINK THERE'S REALLY A
DOUBLE VISION HERE ABOUT WHAT IT
IS WE'RE TRYING TO DO WITH
COMPENSATION AND DIFFERENT KINDS
OF COMPENSATION.
>>RIGHT.
NEXT QUESTION IS, RELATED TO
THIS ONE, SOMEONE POINTS OUT
THAT INCENTIVE STRUCTURES FOR
RESEARCHERS, SO PEOPLE LIKE THE
RESEARCHER IN THIS CASE, PEOPLE
AT THE NIH, PEOPLE AT HARVARD,
INCENTIVES AREN'T COMING IN JUST
THROUGH POTENTIAL SHARING AND
PROFITS.
THERE'S LOTS OF OTHER WAYS WE
INCENTIVIZE THEM.
THEY GET TENURE, YOU GET
PROMOTION, YOU GET RAISES, YOU
GET FIRST AUTHOR PUBLICATIONS IN
THE NEW ENGLAND JOURNAL OF
MEDICINE, YOU GET FANCY AWARDS,
REALIF YOU'RE REALLY GOOD AND RY
LUCKY.
SO THE QUESTION WAS, SHOULD WE
BE LEVELING DOWN WITH THOSE OR
BE WORRIED ABOUT THOSE IN THE
SAME WAY?
IS THERE A SIMILAR WORRY RAISED
BY THOSE OR ARE THEY SOMEHOW
DIFFERENT?
>>IT'S A GREAT QUESTION.
IN SOME WAYS I'LL SAY DEPENDING
ON HOW VALUABLE IT IS, TENURE
MIGHT BE WORTH A LOT MORE TO
YOUR LIFE AND HOW YOUR LIFE GOES
THAN THIS OTHER THING.
IT'S SORT OF INTERESTING WHAT WE
CAN QUANTIFY OR NOT.
SO HERE ON THE FLIP SIDE, ONE
THING WE'RE SEEING MORE IN THE
RESEARCH ETHICS COMMUNITY IS
INCLUDING PARTICIPANTS IN
AUTHORSHIP TITLES OR AS PART OF
AUTHORSHIPS GROUP OR
ACKNOWLEDGMENT.
THERE IT'S NOT SO MUCH AS AN
INCENTIVE AS IT'S MORE
DIGNITARIAN IN MY OPINION AS TO
SAY HERE'S A WAY I CAN
ACKNOWLEDGE WHAT YOU'VE
CONTRIBUTED AND BASICALLY, YOU
KNOW, OFFER YOU A KIND OF
DIGNITY OF THE WORK THAT YOU'RE
DOING.
I'LL JUST SAY ONE MORE THING
THEN I'LL BE CURIOUS WHAT MY
COLLEAGUES THINK, IS THAT ONE
THING IN THE BACKGROUND OF ALL
OF THIS IS A QUESTION ABOUT
WHETHER WE SHOULD THINK OF
RESEARCH ETHICS AS WORK OR
RESEARCH PARTICIPATION, I SHOULD
SAY, AS WORK OR NOT.
THERE ARE SOME PEOPLE WHO THINK
THAT ACTUALLY WE SHOULD VIEW
RESEARCH PARTICIPANTS AS
WORKERS, WHICH MIGHT LEAD YOU TO
THINK THE THINGS LIKE EMPLOYMENT
LAW OR EVEN UNIONS, LIKE SHOULD
THERE BE A UNION OF RESEARCH
PARTICIPANTS?
CERTAINLY THERE ARE PROFESSIONAL
RESEARCH PARTICIPANTS CALLED
PROFESSIONAL GUINEA PIGS IN SOME
WAYS, AND THAT'S THE PLACE OF
THE EXTREME CASE.
BUT THE MORE YOU VIEW RESEARCH
WORK AS JUST ANOTHER KIND OF
WORK, THE MORE THAT YOU TAKE THE
LOGIC OF THE MARKET IS THE RIGHT
ONE FOR IT.
THE MORE YOU THINK THAT IT'S A
KIND OF FIDUCIARY, DUTY-BOUND OR
RESPECTFUL KIND OF THING, THE
LESS YOU MIGHT BE ATTRACTED TO
THE DISCUSSION OF THIS IN
MARKETTIZED TERMS.
>>GREAT.
OKAY.
THESE ARE GREAT QUESTIONS.
A COUPLE ARE COMING FROM YOU SO
I WANTED TO GIVE YOU A 10-SECOND
BREAK THERE BEFORE I ASK YOU THE
NEXT ONE.
THIS IS GOING TO BE LIKE FIRING
SQUAD WITH HARD QUESTIONS.
THERE'S GOING TO BE BLOOD ALL
OVER THE BACK OF THE CHAIRS BY
THE TIME YOU'RE FINISHED.
SO SOMEBODY HAS ASKED -- SO THIS
IS RELATED TO -- THIS ONE IS
RELATED TO THE POINT ABOUT
WHETHER OR NOT WE CAN TAKE A
MORE MARKET APPROACH TO THE WAY
WE THINK ABOUT RESEARCH SUBJECTS
AND THEIR ROLES AND THEIR
CONTRIBUTIONS, AND POINTING OUT,
WHAT IF WE IMAGINE THAT RESEARCH
PARTICIPANTS OR SAMPLE DONORS
ALL BAND TOGETHER AND THEY GIVE
THIS OFFER TO -- I DON'T KNOW
WHO THEY WOULD GIVE THE OFFER
TO -- COMPANIES OR BIOETHICS OF
THE NIH, AND ALL THE POTENTIAL
SAMPLE DONORS OR RESEARCH
PARTICIPANTS SAY WE'RE WILLING
TO BE -- OF THIS BUT WE'RE ONLY
GOING TO BE PART OF THIS IF WE
GET SOME SHARE IN THE PROFITS,
OR AT LEAST THE PEOPLE WHO
PARTICIPATE IN THE STUDY SHOULD
GET A SHARE IN THE PROFITS.
SO THE QUESTIONS ARE, ONE, IF
THEY DID THAT, IT MIGHT BE A
GOOD OR A BAD THING, AND THEN
THE SECOND QUESTION IS, IS THE
FACT THAT THEY HAVEN'T DONE
THAT, PRESUMABLY IT'S SOME SORT
OF HAPPENSTANCE, THEY JUST
HAVEN'T ORGANIZED IN A
SUFFICIENTLY PROPER WAY, AND IF
THEY DID, THEY WOULD GET THESE
PROFITS.
SO IS THE CURRENT STRUCTURE IN A
WAY JUST EXPLOITING THE FACT
THAT THESE PEOPLE HAVEN'T BEEN
ABLE TO BAND TOGETHER IN THE
RIGHT SORT OF WAY?
>>IT'S A GREAT QUESTION.
I'LL SAY IT'S NOT COMPLETELY
HYPOTHETICAL.
IN SOME RARE DISEASE GROUPS, FOR
EXAMPLE, THERE HAVE BEEN A KIND
OF SIDE BARGAINING WITH
COMPANIES DEVELOPING PRODUCTS
AND ACTUALLY ONE OF THESE WENT
IN A BAD DIRECTION.
A CASE AGAINST THE -- THE
GREENBERG CASE OUT OF MIAMI,
WHICH IS ABOUT, IF I REMEMBER
CORRECTLY, CATAVANSX, PARENTS
WHO HAD THE SAMPLES TRIED TO
ORGANIZE IN THIS WAY, NOT FOR
ACTUALLY THEY WANTED TO MAKE
MONEY BUT ACTUALLY FOR
AGREEMENTS WITH THE COMPANY, IF
I RECALL IT CORRECTLY, ON HOW
THE ULTIMATE DRUG WOULD BE
PRICED AND SORT OF PROFIT
SHARING DOWN THE ROAD OR
PAYBACK, RIGHT?
SO THIS IS NOT A FACETIOUS OR
HYPOTHETICAL EXAMPLE.
FOR ME, THE QUESTION -- SO IT
TAKES US BACK TO THE QUESTION OF
DESSERT.
THE MORE WE'RE ASKING A LOT OF
THE INDIVIDUAL PEOPLE, SO WE'RE
ASKING TO YOU DO SOMETHING
THAT'S UNIQUE TO YOU AND TO MAKE
A SACRIFICE THAT'S UNIQUE TO
YOU, THE MORE IT LOOKS TO ME
LIKE IT'S WORK.
THE MORE WE'RE ASKING TO YOU
SHARE SOMETHING IN A RELATIVELY
KIND OF LOW DEMAND SORT OF WAY
THAT IS NOT IMPOSING A LOT ON
YOU AND FOR ACTUALLY -- IT'S NOT
SOMETHING SPECIFIC ABOUT YOU.
SO ANOTHER WAY OF PUTTING THIS,
I'M SORRY TO BE SLIGHTLY -- IT'S
A GREAT QUESTION SO MAYBE I'M --
A LITTLE BIT BUT HERE'S WHAT
I'LL SAY, IS ONE OF THE REASONS
WHY WE HAVEN'T SEEN THIS VERY
MUCH IS IN A POST THEOLOGICAL
MANNER, IT REQUIRES A GROUP OF
PEOPLE WHO ARE PRETTY CLOSELY
BOUND TOGETHER TO UNDERSTAND
THEMSELVES TO BE PART OF
COMMUNITY.
TO BARGAIN IN THIS WAY.
WHEN YOU'RE TALKING ABOUT TAKING
ANTIBODIES FROM PEOPLE WHO HAVE
HAD COVID, THERE'S A LOT OF
PEOPLE IN THE WORLD WHO HAVE HAD
COVID.
WE DON'T KNOW VERY MUCH ABOUT
OUR ANTIBODY, WE DON'T IDENTIFY
OURSELVES AS PEOPLE WHO HAD
COVID AND THINK THAT WE'D GET
TOGETHER.
WHEN YOU TALK ABOUT A SMALL RARE
DISEASE GROUP BY CONTRAST, THEY
ARE PEOPLE WHO HAVE A THICK
CONNECTION WITH ONE ANOTHER AND
WHO HAVE GOALS THAT ARE VERY
WELL ALIGNED.
TO ME, THE EXPLANATION WHERE
WE'VE SEEN AND WHERE WE HAVEN'T
IS DIRECTLY RELATED TO THINGS AS
A SOCIOLOGICAL MANNER.
>>RIGHT.
A COUPLE PEOPLE ARE JUST
POINTING OUT THAT -- AND GLENN,
YOU BRIEFLY MENTIONED THIS AT
THE BEGINNING WHEN WE START
THINKING ABOUT SELF-EX-PAIR
MENTATION IN A WAY YOU COULD
SORT OF ROUGHLY THINK ABOUT THIS
IN THAT LIGHT, THAT THERE'S AN
INTERESTING OR NOVEL KIND OF
CONFLICT OF INTEREST THAT GETS
INTRODUCED WHERE YOU HAVE THE
RESEARCHER WH'S ALSO THE
PARTICIPANT AND IN THIS CASE YOU
MIGHT WORRY PARTICULARLY IF WE
WENT WITH THE SCHEME WHERE THE
SAMPLE DONORS GET TO SHARE
IN THE PROFITS, WHERE YOU MIGHT
IMAGINE THAT THEN RESEARCHERS
JUST MIRACULOUSLY KEEP FINDING
THAT THEIR CELLS ARE THE MOST
POTENT ONES AND THOSE ARE THE
ONES WHO GET DEVELOPED FOR
VACCINES, RIGHT?
NOW, JEFF CAN COMMENT ON THIS IF
HE WANTS, BUT MY UNDERSTANDING
IS THAT THAT WASN'T THE WORRY IN
THIS CASE, THERE REALLY WAS
EVIDENCE IN THIS CASE THAT THE
INVESTIGATOR'S WAS THE MOST
POTENT, BUT I THINK AS A GENERAL
POINT, IT'S RIGHT, AND I THINK
IT COMES BACK TO THE QUESTION
I'D ASKED GLENN A COUPLE AGO,
WHICH IS THAT BY INCENTIVIZING
RESEARCHERS, COMPANIES AND
OTHERS, WE BOTH INCENTIVIZE GOOD
BEHAVIOR AND SOMETIMES BAD
BEHAVIOR, AND WE NEED TO FIGURE
OUT HOW THOSE THINGS WASH OUT.
BUT MY UNDERSTANDING IN THIS
CASE, IT GENERALLY IS AN ISSUE
BUT NOT NECESSARILY IN THIS
CASE.
I DON'T KNOW IF YOU HAVE ANY
THOUGHTS ON THAT, JEFF, OR
COMMENTS?
YOU'RE MUTED, JEFF.
>>IN THIS CASE, THE RESEARCHER
WAS ACTUALLY UNCOMFORTABLE WHEN
THEY FOUND OUT THAT THEY HAD THE
HIGHEST LEVEL OF ANTIBODY.
AND ALTHOUGH THEIR ANTIBODY WAS
HIGHER THAN THE OTHER ONES, IT
WAS NOT HUGELY HIGHER, AND THE
RESEARCHER ACTUALLY DECIDED TO
USE OTHER PARTICIPANTS' CELLS
FOR THIS.
THERE WAS JUST SOME ETHICAL, YOU
KNOW, DILEMMA THAT THE
RESEARCHER FELT LIKE, AND AGAIN,
I THINK IT COULD GO BOTH WAY, IF
THE RESEARCHER'S SAMPLES WERE
REALLY BETTER, YOU KNOW, MAYBE
THEY SHOULD HAVE BEEN USED.
BUT THERE WERE CONCERNS THAT
DOWN THE ROAD, YOU KNOW, THAT
THIS COULD CAUSE PROBLEMS AND
THEY JUST DIDN'T WANT TO HAVE IT
REALLY TRULY INTERFERE WITH
THEIR RESEARCH, PER SE.
>>SO ANOTHER QUESTION FOR YOU,
JEFF, IF YOU HAVE ANY THOUGHTS
ON THIS GLENN WAS SUGGESTING, AS
HE POINTED OUT, THAT CURRENT
PRACTICE IS DIFFERENT BETWEEN
RESEARCHERS AND SAMPLE DONORS
AND I WAS IN EFFECT ARGUING THAT
AT LEAST IN SOME CASES, WE
SHOULD AS PHILOSOPHERS LEVEL UP
AND WE SHOULD SHARE PROFITS WITH
BOTH RESEARCH PARTICIPANTS AND
RESEARCHERS.
GLENN SUGGESTED, WELL, MAYBE IT
SHOULD GO THE OTHER WAY FOR A
NUMBER OF INTERESTING REASONS,
AND WE SHOULD INCENTIVIZE
RESEARCHERS, JUST LIKE WE DON'T
INCENTIVIZE RESEARCH
PARTICIPANTS.
ANY THOUGHTS ON THAT, JEFF, FROM
A RESEARCHER PERSPECTIVE ABOUT
SAYING, ALL RIGHT, MAYBE WE
SHOULDN'T HAVE THESE KINDS OF
FINANCIAL INCENTIVES FOR
RESEARCHERS?
>>YEAH, I'M A LITTLE BIT
WORRIED THAT IF ONE INSTITUTION,
LET'S SAY THE NIH, HAS A POLICY
AND THE UNIVERSITIES MAY NOT
HAVE A POLICY OR HAVE A
DIFFERENT POLICY, IT COULD
INCENTIVIZE PEOPLE TO LEAVE
WHERE THEY ARE AND MOVE TO A
PLACE WHERE THEY HAVE A BETTER
CHANCE OF PROFITING FROM THEIR
INVENTIONS, PARTICULARLY IF
THEY'RE A RESEARCHER THAT REALLY
IS GETTING CLOSE TO DEVELOPING
THINGS.
SO THINK WE HAVE TO BE VERY
CAREFUL NOT TO -- TO HAVE A
POLICY THAT'S CONSISTENT.
' WE SEE THIS, OF COURSE, WITH
SOMETIMES RESEARCHERS STARTING
COMPANIES AND THINGS, BUT I JUST
THINK WE WANT TO BE CAREFUL THAT
SOTHERE'S SORT OF A LEVEL PLAYIG
FIELD.
INTERESTING TO HEAR WHAT GLENN
HAS TO SAY.
>>GLENN, ANY ADDITIONAL
THOUGHTS ON THAT?
>>NO, I THINK THAT'S EXACTLY
RIGHT, THAT THERE'S THIS
QUESTION OF -- THERE ARE
DIFFERENT EQUALLY BREE UM -- YOU
DON'T WANT TO BE IN THE CASE
THAT YOU'RE NOT DOING WHAT
EVERYBODY ELSE IS.
NIH HAS AMAZING WONDERFUL
SCIENTIST, ALREADY HAS TRIED
VERY HARD TO RETAIN THEM AS
AGAINST THE PRIVATE SEC, TO AND
IT WOULD BE A SHAME IF THIS WAS
ONE ADDITIONAL REASON WHY THE
PRIVATE SECTOR WAS ABLE TO --
>>SO THE QUESTION THAT SOMEBODY
POINTED OUT, I'VE BEEN THINKING
ABOUT IN THE PAST AND ALSO IN
PREPARING FOR THIS,
APPARENTLY -- I DIDN'T KNOW
THIS, BUT AT LEAST THE
QUESTIONER SAYS THAT ACCORDING
TO WTO, THE WORLD TRADE
ORGANIZATION, PATENTS ARE -- AND
THERE'S A QUOTE HERE, I DON'T
KNOW IF THIS IS RIGHT, BUT THEIR
INTELLECTUAL PROPERTY THAT
INDIVIDUALS GET RIGHTS OVER
CREATIONS OF THEIR MINDS.
AND THIS IS SOMETHING THAT I
THOUGHT WAS INTERESTING IN
THINKING ABOUT CURRENT PRACTICE.
AND IT SEEMS TO ME, MAYBE
THERE'S SOME MORE RADICAL PERSON
WHO'S WRITTEN ON THIS, IT WOULD
BE INTERESTING, BUT IT SEEMS TO
ME THAT -- I DON'T KNOW WHAT YOU
THINK ABOUT THIS, GLENN, BUT
THERE'S ARGUABLY A WAY IN WHICH
CURRENT PRACTICE SEEMS TO
PRIVILEGE OR PRIORITIZE
CONTRIBUTIONS THAT COME FROM
PEOPLE'S MINDS OR PEOPLE'S
BRAINS OVER CONTRIBUTIONS THAT
COME FROM PEOPLE'S BODIES.
SO SOME PEOPLE, WHEN I TALK
ABOUT THIS ISSUE, THEY'LL SAY,
LOOK, DAVE, THERE'S A HUGE
DIFFERENCE BETWEEN THE KINDS OF
CONTRIBUTIONS THAT RESEARCHERS
MAKE AND THE KINDS OF
CONTRIBUTIONS THAT PEOPLE LIKE
HENRIETTA LACKS MAKE THE LONG
TERM NON-PROGRESSORS, MAYBE
RESEARCHERS LIKE THE PRESENT
ONE.
IN THE CASE OF THE RESEARCHERS,
IT'S THEIR MINDS, THEIR
THINKING, THEY'RE COGITATING,
THEY GOT AN EDUCATION, IT COMES
FROM THEIR MINDS.
IN THE CASE OF THE PARTICIPANT,
IT'S COMING FROM THEIR BODIES.
AND I THINK IT DOES SEEM TO ME
THAT THERE'S AT LEAST ARGUABLY A
DIFFERENCE IN THE WAY WE TREAT
THOSE NOW, AND I THINK THE
QUESTION -- IT WOULD BE VERY
INTERESTING -- FROM AN INCENTIVE
POINT OF VIEW IF THAT DIFFERENCE
MAKES SENSE, MAYBE IT DOESN'T
MAKE SENSE FROM A INCENTIVE
STRUCTURE APPROACH BUT MAYBE AT
LEAST SOME PEOPLE THINK -- I
DON'T KNOW IF IT'S A BIAS OR
NOT, MY WORRY IS TO THINK THAT
IT A KIND OF PRIVILEGING OF THE
PEOPLE WHO PROBABLY WROTE THE
RULES IN THE FIRST PLACE.
THEY WERE PROBABLY THE SMARTER,
MORE EDUCATED PEOPLE, AND THEY
THOUGHT, YOU KNOW, WHAT WE
REALLY PRIORITIZE, SO THEY WERE
THE PEOPLE WHO WORK AT THE NIH
AND WORKED AT HARVARD, THEY
WEREN'T MICHAEL PHELPS AND
PEOPLE WHO CAN DUNK FROM THE
FOUL LINE.
SO THEY WERE PRIORITIZING THE
MENTAL OVER THE PHYSICAL.
BUT IT DOES SEEM TO ME THAT
THERE IS THAT DIFFERENCE, AND
I'M AT LEAST A LITTLE SKEPTICAL
OF IT, SO WE ONLY HAVE 2 MINUTES
AND THIS IS OBVIOUSLY JUST AN
ENORMOUS QUESTION, AND LET ME
APOLOGIZE AGAIN, THERE ARE SOME
QUESTIONS WHICH I JUST HAVEN'T
GOTTEN TO WHICH ARE WONDERFUL
QUESTIONS.
THIS DID TURN OUT -- I WILL SAY
I WAS DEFINITELY RIGHT IN THIS
REGARD, THIS WAS A GREAT TOPIC
AND I'M REALLY GLAD WE DID IT,
AND THANK YOU VERY MUCH TO GLENN
AND JEFF FOR BEING WONDERFUL
PARTICIPANTS IN IT.
BUT WE JUST HAVE ABOUT A MINUTE
AND A HALF LEFT, GLENN.
I DON'T KNOW IF YOU WANT TO
COMMENT ON THAT OR ANYTHING ELSE
THAT REALLY STRIKES YOUR --
>>YEAH.
SO I WOULD SAY THE -- IS BODIES
VERSUS MINDS, ELSEWHERE IN THE
WORLD, THERE'S A LOT OF EFFORT
INVOLVED IN BEING A MODEL AS
WELL, BUT WE'RE NOT LIKE AGAINST
REIMBURSING PEOPLE ON A
DIFFERENT RATE BASED ON
DIFFERENCES IN THEIR BODY.
I THINK TO ME, IT'S WHETHER
THERE ARE THINGS YOU CULTIVATED
AND YOU HAD EFFORT INVOLVED IN
VERSUS NOT.
RIGHT?
SO THE QUESTION FOR ME IS -- SO
I THINK ABOUT SOMEONE LIKE
AI-GENERATED ART AS AN
INTERESTING EXAMPLE, RIGHT?
YOU PUT IT IN, IT HAS AN OUTPUT.
THE PERSON WHO CREATES THE AI,
THEY DESERVE COMPENSATION.
BUT IF I SAY HERE'S SIX RANDOM
NUMBERS AND IT'S GOING TO
GENERATE A PAINTING, IS THE
PERSON WHO GENERATES THE NUMBERS
DESERVE COMPENSATION?
TO ME THESE ARE ALL CONNECTED
BUT THERE'S AN OVERARCHING
QUESTION WHICH IS WHAT KIND OF
SOCIAL PRACTICE IS RESEARCH?
IS IT LIKE THE SOCIAL PRACTICE
OF SPORT, IS IT LIKE THE SOCIAL
PRACTICE OF ART, IS IT LIKE THE
SOCIAL PRACTICE OF MODELING, OR
IS ITITY OWN T IT ITS OWN THINGN
ORGANIZING PRINCIPLES?
>>WOW.
WE'RE JUST AT TIME.
SO I WANT TO THANK JEFF AND
GLENN AGAIN FOR A REALLY
WONDERFUL SESSION AND FOR ALL OF
THE QUESTIONS.
I'LL TRY TO GET TO THE ONES I
DIDN'T GET TO, AND FOR EVERYBODY
ELSE, THANKS FOR TUNING IN, AND
WE HOPE TO SEE YOU THE FIRST
WEDNESDAY IN FEBRUARY, WHEN
WE'LL HAVE A GREAT SESSION
ACTUALLY ON VACCINES FOR COVID,
AND WE'RE TRAGOONING AND
DRAGGING BACK IN A SENSE THE
FOUNDER OF THESE ETHICS GRAND
ROUNDS WHO WAS THE HEAD OF
BIOETHICS AND IS NOW AT PENN TO
BE THE DISCUSSANT.
SO UNTIL THE FIRST WEDNESDAY IN
FEBRUARY, I HOPE EVERYBODY HAS A
GOOD REST OF THE YEAR.
THANKS, YOU GUYS.