Tuesday, August 1, 2017

Using poor, uninsured minorities to test the safety of experimental drugs

My latest article on the topic, in Clinical Trials. Here is how it begins.

In 2004, a pharmaceutical researcher in Alabama offered a paycheck to 21 clients of a Mobile homeless center in exchange for testing an experimental smallpox vaccine. These people could expect little medical benefit from the study, of course. Smallpox was eradicated in 1980, and in the absence of a bioterrorist attack on Mobile, it was unlikely that clients of a homeless center there would need protection from it. But medical benefit was not really the point. The main purpose of these studies was to see if the experimental vaccine carried unpleasant or dangerous side effects.

In some ways, studies like this are not unusual. Pharmaceutical companies routinely pay desperately poor subjects to test the safety of experimental products. In this case, however, 2 of the 21 subjects had to be hospitalized, one of them for acute myocarditis — an inflammation of the heart muscle that can cause sudden death. A third subject contracted pericarditis. It did not help that the research team lost this subject’s medical files for two years, one of many blunders that attracted federal scrutiny. When the Food and Drug Administration (FDA) investigated in 2007, it found a host of risky research practices ranging from careless record-keeping to dubious recruiting procedures, as well as little meaningful oversight by the Institutional Review Board. The FDA eventually disqualified the researcher in 2008, effectively barring him from doing any more studies. But he continues to practice medicine in Alabama, marketing sexual enhancement procedures as "Dr. Orgasm."

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