The Lingering Questions About Human Medical Experiments

The lessons of Tuskegee and Guatemala have a presidential commission reviewing how the government protects vulnerable test subjects. A committee member explains the ugly past and the safeguards in place now.

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The specter of the Tuskegee Syphilis Study inevitably looms over talk of human subjects in medical research. The well-known case involved the U.S. Public Health Service, which, from 1932 to 1972, studied hundreds of black men in Alabama with syphilis, failing to inform them of their diagnosis or treat their condition. From this striking example of a disregard for ethical standards and the lives of these men, many African Americans harbor deep suspicions about government-sponsored medical studies.

The Tuskegee experiments, however, are one of many disturbing cases over the field's history, in which tests were often performed on nonconsenting mental patients, prisoners, poor blacks and people overseas. Last year, when a Wellesley College professor unearthed hidden files detailing U.S. government experiments in Guatemala in the 1940s, where scientists infected hundreds of people with syphilis, President Barack Obama apologized to the Guatemalan government and people, vowing never to repeat the atrocities of the past.

With that, Obama directed the Presidential Commission for the Study of Bioethical Issues to conduct a thorough review of the Guatemala experiments and current regulations for federal research. He asked the 13-member advisory council to assure him that federal laws effectively protect research participants, both domestically and abroad, from harm and unethical treatment. Its report is due to the president by September.

The bioethics commission held a meeting in Washington, D.C., this week to review the initial results of its investigation. The Root talked to commission member Anita L. Allen, a professor of law and philosophy at the University of Pennsylvania Law School, about U.S. medical studies performed in Africa and South America, the ethical concerns of conducting research in prisons and whether anybody is likely to get a government apology again.

The Root: U.S. clinical studies are increasingly conducted abroad, with a particular focus in sub-Saharan Africa and Latin America. Why are pharmaceutical companies targeting these parts of the world?

Anita L. Allen: One motivation for doing human-subjects research abroad is that sometimes the needs for the clinical investigations are abroad -- that is to say, some medical conditions are more common in developing countries than in the developed world. So the researchers are going where the need is. What we heard at the meeting this week is that developing countries are seen to benefit from having investigators internationally come in and conduct clinical trials.

TR: What are some examples of conditions that could not just as easily be researched on people in the United States instead of, say, Nigeria?

Another rationale we heard was cost. It can be less expensive to do research in a developing country than in the United States. However, we also heard the argument made that, sometimes, not counting some of the ancillary costs of research makes it appear that research abroad is cheaper. If researchers addressed all the social and medical needs of a population -- their underlying, more holistic health concerns -- then we might realize that research in these countries is more expensive than it seems. But people are looking for cost-effective places in which to do this very expensive research.

Unfortunately, to some extent it is also a lack of regard for the human rights of people in developing countries that may have prompted some researchers to seek out these domains for this research. We heard a combination of reasons.

TR: Now that you have this information, what is the commission doing next?