Whose life, whose death?: Pharmaceutical trials in the developing world

The number of clinical trials being undertaken in developing countries has increased significantly in the last three decades. For pharmaceutical companies, the move to undertake trials in developing economies presents a convenient cost- and time-saving measure. However, this trend raises some pertinent ethical questions. This article examines whether the use of a trial drug or treatment, where no other choice exists, is a form of coercion; if it is ethical to run a trial of expensive new drugs in an impoverished country where that particular medication will, in all likelihood, never be affordable for most people; and, finally, whether it is acceptable to conduct a trial on subjects without their explicit and informed consent, even if the researchers are reasonably certain the drug is better than the current ‘gold standard’. The regulatory regimes in most developing countries are less stringent than in the developed world, and the risks are more difficult to explain as a result of cultural barriers, poverty and educational disadvantage. The locations and regulation of clinical trials should be the concern of all who benefit from treatment with new and emerging drugs.