October 27, 2008

Keeping an Eye on Medical Research Ethics

This weekend, I read Harriet A. Washington’s “Medical Apartheid,” which documents the shocking history of abuse and unethical practices in the conduct of medical research on black Americans. While many of you may have heard of the Tuskegee syphilis experiment, Washington’s work is much more comprehensive, outlining and tying together events from slavery to recent decades.

While reading this work, I wondered how we can “ask hard questions of the physicians who are recruiting in your community,” as Washington urges. It seems that we often only learn of these incidents long after they have occurred, such as through reading this text, and we should keep an eye not just on ethical problems of studies recruiting in our own communities, but wherever medical research is conducted. How do we know what research is being done across the country, before it is reported in the news or books?

One possibility is to examine trials listed in the freely available database of trials funding by the National Institutes of Health (and some other entities). For example, a search for terms such as “prison” and “incarcerated” can give us a clue about the types of research being done in this vulnerable population, and we can at least see a summary of the rationale and who is being included and excluded from the research. The clinicaltrials.gov advanced search does not provide for easy searching by the study’s population group, but keyword searching for terms such as “prison,” “african american,” “low income” and “pregnant” may be useful.

It’s not the neatest method in the world, but a search of the database for “african american” returned at least one study that raised questions, although it is one that has already been completed (with no reporting publications available). The study, “Metabolism of Nicotine and Cotinine in Pregnant African-American Women,” focused on the use of the nicotine patch in pregnant smokers. Reading the summary, I wondered why they focused on this population (has any plausible biological explanation been offered?), why they enrolled pregnant women who “cannot quit smoking within 7 to 10 days after receiving counseling” (is that a reasonable expectation?), and why they applied nicotine patches to these women after preventing them from smoking for 48 hours, enough time for the nicotine levels in their bodies to drop significantly. It seems that they wanted to study how the substances from the patch were metabolized, but I have to wonder if, after a pregnant woman has been without nicotine for 2 days, whether it might be more ethical to help her continue on that path rather than slapping a nicotine patch on her for up to a day (even though it wouldn’t serve the research goal). The summary does not give any indication of whether the women were further assisted with smoking cessation after the end of the trial.

Although further details might be warranted for critique of this specific study, they are not available in a publication, and this example suggests the kinds of questions and concerns that might be raised through keeping an eye on descriptions of federally funded research. It would be a very big job to independently monitor the numerous existing trials, but this, perhaps, is one place to start.


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