There are, however, very strong medical, scientific, and economic arguments for conducting clinical trials in the poor world. The drugs tested might be intended for the population testing them; the trials might benefit from genetic diversity; or the trials, usually the most expensive part of the drug development process, might be cheaper. Given that clinical trials will be conducted in the poor world, what would be a better system?
The ethical requirements for human research were established by international agreements such as the 1964 Helsinki declaration. They include various commonsense rules: for instance, physicians ought to consider the health and well-being of subjects above other considerations; any adverse effects that occur during the course of a study should be scrupulously monitored, reported, and treated; researchers must fully communicate potential risks and benefits; and subjects must not be coerced into participating. Most importantly, the subjects of a trial should bene-fit personally from the results of the research (that is, they should not be induced to participate in a trial for solely economic reasons).
But obvious difficulties arise in interpreting these principles and applying them in impoverished settings. A common dilemma is, Just what constitutes excessive inducement? If researchers pay for their subjects’ transportation and lunch, or reimburse them for missing a day of work, is that a bribe? What if they offer direct payments?
Informed consent is particularly elusive in places where patients are not well educated and where doctors’ authority looms large. Informed-consent agreements are lengthy, bureaucratic documents. One recent improvement is to supplement documents with -visual aids and require patients to answer a brief quiz to ensure they have really comprehended the nature and terms of the transaction. It is important that patients understand they may leave the trial whenever they wish and will -neither be punished nor lose their primary health care.
Among the most vexing questions is, Who should oversee the people who oversee clinical trials? At NIH, where HIVNET 012 has cast a long shadow, there is a growing interest in supporting the work of local ethics committees. But local groups often lack the training and resources to do much. One study, which appears in the March-April issue of IRB: Ethics and Human Research, suggests that many African groups are susceptible to influence and have limited expertise.
A variety of promising initiatives, sponsored by international bodies like the World Health Organization (WHO), may help these groups to grow stronger. WHO is funding projects that teach ethics and provide infrastructure. This sounds sane: American and European private and public institutions cannot provide the oversight required for ethical clinical trials in the poor world, particularly when Ameri-can and European pharmaceutical companies are involved.
Read together, the Farber and Kahn pieces, apparently so different, disturb. While Farber’s malignant vision of clinical trials is obviously unhinged, it does remind us that clinical trials are not without risks for their subjects. Kahn dramatizes another uncomfortable fact: that economic disparity between investigators and subjects in human research creates possibilities for abuse and coercion – possibilities that we do not really know how to manage. Considered in combination, these realities may not justify pharmanoia, but they explain it.
“Out of Control”
By Celia Farber
Harper’s, March 2006
“A Nation of
By Jennifer Kahn
Wired, March 2006
Amanda Schaffer writes about science and medicine for Slate.