11. Exploitation

8/20/2019 11. Exploitation

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Exploitation in Clinical Resear

chAlan Wertheimer

2014-04-23.

박희정 , 박창식 , 김현대 , 안선주


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What Makes Research Ethical

• “ The overarching objective of clinical research is to develop generalizable understanding of human biology ; subjects who participate are the means to securing such knowledge. By placing somepeople at risk of harm for the good of others, clinical research has the potential for eploitation of human subjects.!

• “"thical re#uirements for clinical research aim to minimize the possibility of eploitation by ensuring that research subjects are notmerely used but are treated with respect while they contribute to

the social good.!


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Non-Exploitation andthe NIH Canon

• $ocial value

• $cientific validity

• %air subject selection• %avorable risk&benefit ratio

• 'espect for human subjects

• (ll those principles can be interpreted as ways of avoiding eploitation.


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What is Exploitation?


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Exploitation in Research

• )ulnerable populations – *mpaired

– *nstitutionalized

– +ow income

• +ess developed countries – lacebo controlled trials when proven effective treatment is a

vailable – -hen intervention is likely to be used for benefit of develope

d countries

– ff&shoring of clinical research


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Three Examples

• /aternal&%etal Transmission of 0*)

• $urfain

•

1iabetes 1rug


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Maternal-Fetal Transmissionof HIV

• Efficac of !on" Co#rse Treatment of $%T had &een esta&lished – (T23 maternal&fetal transmission of 0*) 4 567

• 'nfeasi&le ( too expensi)e in less de)eloped co#ntries

• Researcher *anted to in)esti"ate efficac of +ho

rt Co#rse Treatment – 8heaper and easier to administer, wouldn9t be as effective as

+ong 8ourse Treatment


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Maternal-Fetal Transmission of HIV

• Compared efficac of +hort Co#rse Treatment *ithno treatment or place&o

• Intentionall *ithhold esta&lished treatment ,$%T

• !ocal standard of care. nothin"

• /enefit to de)elopin" societies


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The +#rfaxin Trial

• 'espiratory 1istress $yndrome – $tandard 8are3 $urfactant Therapy

– $tandard 8are is "pensive

• 1iscovery +abs wanted to conduct a lacebo&controlled trail in $outh (merica – $urfain was a “me&too! synthetic $urfactant

• *ntentionally withhold standard treatment

• +ocal standard of care3 nothing

• Target /arket3 1eveloped societies


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0ia&etes 0r#" ,Hpothetical

• (merican pharmaceutical company want toconduct a trial of new diabetes medication

• They proposed conducting trial in India beca

use there are many diabetes patients who are “treatment na:ve!

• Target /arket3 1eveloped countries• articipants are compensated or offered pos

t&trail treatment


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Exploitation Claims

• “*f the knowledge gained from the research in s#ch a co#ntr is used primarilyfor the benefit of populations that canafford the tested prod#ct, the researchmay rightly be characterized as eploitative and therefore, unethical.

8ouncil for *nternational rganizations of /edical

$ciences *nternational "thical ??>. @8*/$A


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Exploitation Claim

• 'esidents of impoverished, postcolonial countries, the majority of whom are people of color, must be protected from potential eploita

tion in research. therwise, the abominable state of health care in these countries can be used to justify studies that could never pass ethical muster in the sponsoring country.!

@+urie and -olfeA

• There9s an appeal to a “1ouble $tandard rinciple!


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Three 1#estions

• (re s#&2ects eploited – -hat9s the basis for saying that

• (re comm#nities eploited – -hat9s the basis for saying that

•

$hould we prohibit a trial on the grounds that it is eploitative – The third #uestion in some ways importantly different from the othe

r #uestion.


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Concept of Exploitation

• $ exploits /

*hen $ takes #nfair ad)anta"e of /


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Exploitation Examples

Na3i experiment• (, a Cazi medical scientist• wishes to discover how long a person can live in freezi

ng water.• 0e placed B, who has been placed in a death camp, in

freezing water. B dies within an hour.

4idnes•

(, who is affluent, offers to pay B D>E,??? for one ofhis kidneys for purposes of transplantation.

• B, who is poor, agrees in order to better provide for his family.


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Resc#e• B9s car is in a snow bank on a rural road late at night• ( stops and ascertains that it will take him > min to pull it out• ( offers to pull B9s car out of the snow bank for D>??

+la)er • 8 sells B to ( as a slave• ( forces B to work in the fields for bare subsistence

+*eatshops• Cike hires unemployed people in Thailand• The employees work long hours for DF per hour• -hich is considerably above the average wage in Thailand.


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5rice "o#"in"- 0urricane Gatrina has hit +ouisiana- ( buys >? generators from local 0ome 1epots and +o

ews stores in the 1.8.- 0e sell them to +ouisiana local residents for three time

s the price he paid


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T*o tpes of exploitation

• Harmf#l and nonconsens#al eploitation

•

M#t#all ad)anta"eo#s and consens#aleploitation


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Harmf#l and Nonconsens#alexploitation

• The eploiter benefits

• The eploitee is harmed and does not give valid consent

• "amplesA

– Cazi, $lavery

Harmful and Nonconsensual exploitation

is a no-brainer


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M#t#all $d)anta"eo#s and Consens#al Exploitation

• The eploiter benefits

• The eploitee also benefits and give valid consent

• "amplesA

– Gidney@A, 'escue, $weatshop, rice gougin

gMore complicated

-When is the transaction exploitative?

-Should e prohi!it it?


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When is a transaction #nfair?

• (ppearances can be decei)in"H

– rofessional 'escuer gets D>?? per rescue, but travel

s the highway looking for people to help. 0e averages D>? per hour.

– (mateur 'escuer is an opportunistic passer&by

• *t9s not so easy to tell when a transaction actually is eploitive.


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When is transaction #nfair?

• Taking advantage of vulnerability – 8annot be correct

• 1octors

• +awyers• lumbers

• 1irector of homeless shelter

• 1isproportionate benefit – -hen ( gains much more than B

• $eems plausible, but wrong


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When is transaction #nfair?

• %air surgery vs "ploitive surgery

• B gets lifeH @getting more from the transaction than doctor who is ge

tting some moneyHA

Fair Surgery Exploitative Surgery

A proposes to per"orm li"e-savin#

sur#er$ on % "or a fair fee.

%ecause % ill die unless she

a#rees to the sur#er$, %

authorizes A to per"orm the

sur#er$.

A proposes to per"orm li"e-savin#

sur#er$ on % for twice his normalfee !ecause A nows there are

no other sur#eons availa!le.

%ecause % ill die unless she

a#rees to the sur#er$, %

authorizes A to per"orm thesur#er$.


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• A is ta&in# un"air advanta#e o" %'o!viousl$!ad(

• A is ta&in# advanta#e o" an un"airness to %

or, perhaps, %)s unfortunate or un!ustsituation

e.#.( "nemployed #awyer $

% has !een un!ustly fired. *e as ma&in#

+10,000. A o""ers % a o! teachin# at a

communit$ colle#e "or +30,000.

%n &mportant 'istinction


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Should (e )rohibit Exploitation*

+Mutually %dvantageous and ,onsensual Exploitation


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• " inter"erence is orse "or the exploitessm

then pro!a!l$ not. /ot su!ect protection.- Seatshop

• " inter"erence is !etter "or exploitees or

precents a race to the !ottom, then

pro!a!l$ so

- minimum a#e las

Should (e )rohibit M%,E*

We need to determine hat ill happen i" e

prohi!it hat e re#ard as exploitation +%n

empirical .uenstion


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- &nvestigators orr$ a!out the ethics o" their

activities 'the$ should not exploit(

- /egulators and &/0 orr$ a!out the ethics

o" inter"erin# ith research 'Should the$ stop

investi#ators "rom exploitin#?(

'ifferent /esponsibility


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- 1in any medical study2 every patient

including those of a control group2 if any

should be assured of the best provendiagnostic and therapeutic method34

5he 'eclaration of Helsini

Should we insist on

Standard of ,are )rinciple


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- Maybe3 Such re#ulations ma$ prevent a race

to the !ottom. Similar to minimum a#e las- No3 researchers ma$ #o elsehere i" 5s

such as Sur"axin 5rial are disalloed. 5hereal Sur"axin 5rial

'oes the standard care principle

help sub!ects*

t is an empirical 6uestion as to hether disalloin# 5s

helps potential su!ects.. '7acts matter8(


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,ommunity benefit

- 9eveloped countries are simpl$ exploitin#

impoverished populations- n order to 6uic&l$ use the &noled#e #ained "rom the

clinical trials "or the developed countries) on

!ene"it.

" it is not ron# to as& su!ects to participate

!ecause the$ !ene"it and consent, is it

necessar$ that their "ello citi:ens !ene"it?

'9ia!etes 9ru#(


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'ouble Standard

;esidents o" impoverished, postcolonial countries, the

maorit$ o" hom are people o" color, must !e protected

"rom potential exploitation in research.


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)roblem of 'ouble Standard

+/otavirus vaccine

- @ost common cause o" severe diarrhea amon#

in"ants and children- an !e prevented throu#h vaccination

- accination can have complications

'intussuception(- t is o&a$ to vaccinate children here the virus

prevalent there!$ acceptin# complications- %ut here it is not prevalent B ris&s exceed

!ene"its?


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,onclusion

- We ill not resolve 6uestions as to the

usti"ia!ilit$ o" studied such as 5he Surfaxin

5rial or 5he 'iabetes 5rial !$ appeal to the

derisive lan#ua#e o" exploitation

- We ill resolve them !$ the rigorous

examination of ethical arguments and !$ the

study of the effects of various policies onpeople6s live

11. Exploitation

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