E-DRUG: Ethics on research in developing countries

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E-drug:  Ethics on research in developing countries
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[copied from PROCAARE]

Reference: Gambia Government/Medical Research Council Joint Ethical
Committee* (1998).  Ethical issues facing medical research in developing
countries.  Lancet 351: 286-8

* M.Clarke, A. Collinson, H. Faal, A. Gaye, M. Jallow, A. Joof-Cole, K.
McAdam, M. Schim van der Loeff, V. Thomas, H. Whittle

This strongly worded Viewpoint manuscript takes the position that
"continuation of medical research in less affluent countries is
threatened" by recent articles in the New England Journal of Medicine
(Lurie and Wolfe, 337: 883-5; Angell, 337: 847-9) and the Lancet (350:
897).  In particular, the authors take issue with the assertion that a
clinical study is only ethically designed when it compares new
interventions with the best available interventions in affluent countries.
They assert that therapies which may be beneficial in the controlled
setting  of tertiary care centers are often completely impractical in
resource-poor settings because of expense, heavy patient load, limited
numbers of health care personnel, and difficulty of ensuring patient
compliance.  Consequently, studies evaluating specific interventions in
populations with distinct environmental, socioeconomic, cultural, and
genetic factors are ethically justifiable.

As an example, the authors cite highly active antiretroviral therapy
(HAART), which has become the standard of care in affluent nations.
However, the cost of these agents is prohibitive in Africa, and "the
logistics of treatment and monitoring of side-effects is beyond the dreams
of even the most idealistic".  They state that "feasibility studies are
needed to compare interventions under local conditions with current
standard local therapy, even if that standard is 'nothing'."

A second example is the use of isoniazid TB prophylaxis.  While lifetime
prophylaxis is recommended for PPD-positive HIV-positive individuals in
affluent countries, such a practice is difficult to implement in
resource-poor countries where TB is endemic.  Because the conclusions of
studies on INH prophylaxis in HIV-infected individuals have been different
in Uganda and Kenya, the authors again suggest that therapies shown to be
efficacious in affluent countries under rigorously controlled conditions
may require additional evalution in the developing nations, where
difference in cultural perceptions of illness, health-seeking behaviors
and genetic susceptibility may prove crucial.  In these settings, the
expense and logistical difficulties of providing "best available therapy"
on a national scale may make a placebo group necessary.  Similar arguments
were made for trials of the H. influenzae type b vaccine in the Gambia.

The article emphasizes the importance of ethics committees with members
drawn from the medical, nursing, lay public, government and research
communities.  Such a committee in the Gambia reviews all clinical research
approved by scientific peer review.  The authors feel strongly that
"locally constituted" committees are best able to make the crucial
judgments necessary for the ethical conduct of research.  The authors
conclude that "Stopping trials in Africa that are trying to help improve
the health of poor poeple so that those in affluent countries can have
peace of mind seems a tortured form of ethical logic."

Keywords: clinical science, ethics, clinical trials, developing countries,
HAART, INH, Gambia

From: Albert Shaw <ashaw@usa.healthnet.org>
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