A debate about the exploitation in the field of clinical trials when conducted in developing countries. This presentation talks against the argument.

1. Whether Clinical Trials In Developing
Countries Are Exploitative ?

2. Clinical trial

3. Developing countries
World Economic Outlook Database April 2015 -- WEO Groups and Aggregates Information [Internet]. [cited
2016 May 29]. Available from: http://www.imf.org/external/pubs/ft/weo/2015/01/weodata/groups.htm

4. Report for Selected Countries and Subjects [Internet]. [cited 2016 May 29]. Available from:
http://www.imf.org/external/pubs/ft/weo/2016/01/weodata/weorept

5. 156
196

6. Marxist approach to exploitation
“An individual labor more than is
strictly necessary to meet his or her
own needs and hence more than
would strictly be required to sustain
his or her labor over time . When
the product of this surplus labor is
appropriated by another person, we
have exploitation”
- Jon Elster (Political scientist)
Jon Elster. (1986). An Introduction to Karl Marx. [Online]. Cambridge: Cambridge University Press. Available
from: Cambridge Books Online <http://dx.doi.org/10.1017/CBO9781139163620.

7. Contemporary Non-Marxist Approaches to
exploitation
 Diffuse, unclear ethical concept
A B
Takes advantage in an inappropriate way

8.  A’s proposal is forceful only A proposes to violate B’s rights if B rejects the proposal
 It is just that a rational person would choose participation in a trial over no medical
care

9.  All participants are receive care that is at least as good as and probably better than
if the trial had not been conducted at all
 Those who receive placebo also is not worse than normal care
 There are scientific , social and economic reasons to prefer a PCT to an ACT
 If B is having an illness which works 50% of the time, we won’t object A from
providing it  why we find it wrong as participants can expect to benefit 50% of
the time.

10. Research treatment
 “Although I am a doctor , you are not my patient. I am conducting a trial. If you are
selected to receive Surfaxin, then you will receive care that we think will prove
beneficial. If you are selected to receive placebo, then your baby will not receive
such care. If you don’t want to participate with us on those terms, that’s fine. But I
don’t want you to think that I regard your baby as my patient”
 Why physician patient relationships is automatically applied to relations between
researchers and subjects even if the researchers happen to be trained physicians

11. Exploitation is not limited to clinical research in
developing countries, but in all clinical research
All research “uses” the participants to gain
information

12. Case studies

13. A
• Standard of care
• Ethics of study design
B • Informed consent
C
• Reasonable availability
• Fair compensation

14. The Havrix Trial (1990)
 Kingdom of Thailand
 Population 56.58 million (1990)
 GDP per capita - US$1508
 Health expenditure per capita of GDP 4%
 Health expenditure per capita $109 (1995)
 Life expectancy at birth 70(M) 73 (F)
 IMR – 20.5 per 1000 live births
 Physicians per 100000 – 30
 Place – Kamphaeng Phet , Northern Thailand

15.  Randomized double blind phase 3 trial of Hepatitis A with
Hepatitis B vaccine as control in 40’000 children aged one to
six.
 Walter Reed Army Institute of Research , USA
 SmithKline Beecham Biologicals
 Thailand Ministry of public health
 Incidence – 119 per 100000 population
 Prior JE vaccine study
 No prior agreement to make Havrix available in Thailand

16. Benefits
 40,000 children in trial received Hepatitis B and A vaccines
 Augmented medical services
 Community public health workers for care
 New refrigerators in Public health stations

17.  Inspection of schools and identification of deficiencies in toilet
facilities , hand washing facilities and water storage
 Unlimited stocks of disposable syringes and needles and
training to reduce incidence of blood borne diseases
 Training of Thai researchers
 Experience in conducting further research
 13 senior physicians and US ministry officials to monitor the
safety and efficacy of the trial

18. The Zidovudine trial (1994)
 A study to discover effective approach to maternal fetal
HIV transmission in developing countries , African
countries
 WHO meeting  RCT for shorter and simpler regimen of
AZT vs. placebo
 16 trials in 11 countries , out of which 15 was placebo
controlled ( of which 9 funded by NIH and CDC)

19. International Ethical Guidelines For Biomedical
Research Involving Human Subjects (1993)
 “ As a rule, the sponsoring agency should agree in advance of
the research that any product developed through such
research will be made available to the inhabitants of the host
community at the completion of successful testing. Exceptions
to this general requirement should be justified and agreed to
by all concerned parties before the research begins”

20. Reasonable availability is vague
 No definition of community ?
 Whether to deliver the drugs to all sick person in the
community ?
 How long ? For drugs which need to be taken for life time?
 What if the host country is not able to handle the cost
anytime in the near future?

21.  No single trials ever proves or disproves the effectiveness of
an intervention
 Guaranteeing access after only one trial is unrealistic
 Why responsibility for supplying benefits should rest with the
sponsor ?
 NIH /CDC – which are committed to focus on research and
not health care implementation.

22. The Surfaxin trial (2000)
 Plurinational State of Bolivia
 Population 8.86 million (2005)
 GDP per capita - $2700
 Health expenditure per capita : $179
 Life expectancy at birth 63 (M) and 68 (F)
 IMR – 53 per 1000 live births
 Physicians per 100000 population :73
 Sponsor – Discovery labs, USA

23.  Randomized double blind placebo controlled phase 3 trial of Surfaxin for
the treatment of RDS in 650 premature infants
 Hospitals chosen – NO surfactant available for treatment of RDS
 Sponsors provided – Endotracheal tubes, ventilators and antibiotics for all
study participants
 Team of American Neonatologists to supervise the study and training of
local health care personal
 Ventilator support to placebo is known to improve survival and was better
than the treatments available to both groups prior to study
 No firm agreement was reached before the start of trial regarding
availability

24.  Steering committee composed of host country members to
ensure that appropriate safety standards would be met
 No subjects were denied treatment to which they now have
access
 “the provision of placebo ….to 325 infants in control
group….result in preventable deaths of 16 infants”
 If not engaged in trials  it would have been more
 There are preventable deaths all over the world. If the goal is
to reduce their number, it is not clear what strategy will best
achieve it …

25. Principle of reasonable availability
 Participants take risks in the trial Why the validity of a potential participant’s
consent should be at all related to a decision to make a product available to others
in the post trial environment?
 Why national boundaries are of moral significance?
 If the same trial done by Indian pharmaceutical company ?
 It is mistake to assume as the world is divided into very poor and very rich
 If PCT seeks to test the efficacy of a drug that could be provided to many patients
in a moderately poor nation but would be unaffordable in a very poor nation ?

27.  So if RA is feasible  it will generate a shift from more affluent persons of the
world to less affluent
 If RA is not feasible and a precondition of a trial result in no study at all, and
results in less distribution.

28.  Colonial powers plundered natural resources from countries in the past , so it is
their duty o provide resources to under developed
 Poorest societies of the world are those that have had the least economic contacts
with highly industrialized nations
 They do have such obligation , but insisting on RA is not the best way to fulfill it
Mennis, Bernard. The American Political Science Review 72.2 (1978): 789-90. Web.

29. Informed Consent
 In USA anywhere between 25 – 50% of the subjects do not understand
what it is that they have agreed to.
 Among 200 patients being treated at the University of Pennsylvania
Cancer Center, 40 percent did not know the purpose or nature of the
procedure they had undergone and 45 percent could not give even one
major risk or cite a possible complication resulting from it.
Rothman DJ. The Shame of Medical Research [Internet]. The New York Review of Books. [cited
2016 May 29]. Available from: http://www.nybooks.com/articles/2000/11/30/the-shame-of-
medical-research/