[e-drug] AIDS expert challenges ethical stance on drug trials

E-drug: AIDS expert challenges ethical stance on drug trials
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[Distributed as fair use. HH]

BMJ 2001;323:531 (8 September 2001)

AIDS expert challenges ethical stance on drug trials
Bryan Christie, Edinburgh

Measures to protect people in developing countries from being
exploited in medical research trials may prevent some projects going
ahead that could improve the health of poor people, a leading
scientist has warned. Professor James Whitworth of the Medical
Research Council's programme on AIDS in Uganda said it may not
always be practical to test new treatments against the best
treatment currently available anywhere in the world.

New ethical standards laid down in the revised Declaration of
Helsinki last year stated that testing of drugs in developing
countries should be done against the best current treatment and not
against placebo. This was designed to ensure that local populations
would benefit from trials by gaining access to the best current
treatments.

But Professor Whitworth, speaking at the British Association's
Festival of Science this week in Glasgow, said this might prevent
some ethical and necessary research from going ahead. "The
central problem is trying to be as fair as possible in what is an
unfair and unequal world," added Professor Whitworth. "Of course
the same treatment should be available in Nairobi as New York, but
it isn't and it isn't going to be. The medical problems of the
developing world are immense and urgent. We can't wait for
politicians to create global equity.

"It seems a strange sort of logic to stop doing trials in Africa that
are trying to help improve the health of poor people so that people
in rich countries can have peace of mind."

He also questioned the insistence that informed consent should be
given in writing, when such a process may have little validity in
some cultures.

"Getting a signature on a piece of paper is nice and can be easily
checked but is actually no guarantee of informed consent. Properly
witnessed verbal consent can be much more valid and relevant," he
said.

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