Two faces of research ethics

Inequity, when looked at steadily, is appalling. Here we see it, like a Dementor straight out of Harry Potter, staring us down and threatening our sanity in the middle of nice, clean drug trials. Increasingly, pharmaceutical companies conduct clinical trials of new drugs in developing countries because, without adequate mechanisms for the protection of human subjects and the interference of busybody ethics committees, they can obtain rapid answers and get on with the business of profiteering.

Clinical trials of new medications conducted in developing countries first provoked comment in 1997, when a study of relatively low dose AZT, given late in pregnancy to HIV-positive mothers about to give birth, was compared with treatment with a placebo. By then we knew that high-dose AZT (expensive) given for a longer period during pregnancy had positive consequences for the newborn child. The idea of not treating the controls caused uproar.

Why worry? Firstly, the cost of the new treatment under test is often unaffordable for the country in which the trial is being conducted. When the trial ends, questions arise about continued use of the drug in that country.

Secondly, trials using placebo controls bother some observers. They feel that the control subjects should be offered best care as provided in the country from whence the drug trial emanates. This is difficult when standard care is well beyond the reach of the country where the trial is running. What a mess!

Thirdly, others worry when a trial is conducted, say, in Botswana of a drug of limited relevance there but highly relevant in Germany, where the costs of the trial would be much higher. Rip off?

Ruth Macklin is a New York-based bioethicist with a legal background, which makes her a formidable commentator. She has served on many prestigious international bioethics agencies and inside the NIH. She writes compellingly, lucidly, and in deep detail. She examines the three questions mentioned above, and explores the interplay of science with concerns for human rights, justice, equity, and development. This is not a book for anyone in search of a quick fix or a slick answer. It is, however, chock-full of up-to-the-minute, sophisticated, sound and helpful ethical reasoning and reflection in an area that challenges our humanitarian values head-on.

Stephen R LeederProfessor of Public Health and Community Medicine University of Sydney, Sydney, NSW