Bioethicist Carl Elliot has a supremely powerful, heart-breaking, and rage-inducing feature in the latest issue of Mother Jones. (The full text of the story is now available online.) It examines the ethical dilemmas created by the increasing commercialization of clinical trials. As Elliot writes:
Many clinical studies place human subjects at risk—at a minimum, the risk of mild discomfort, and at worst, the risk of serious pain and death. Bioethicists and regulators spend a lot of time and energy debating the degree of risk that ought to be permitted in a study, how those risks should be presented to subjects, and the way those risks should be balanced against the potential benefits a subject might receive. What is simply assumed, without much consideration at all, is that the research is being conducted to produce scientific knowledge…”
But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to “generate commercially attractive messages”?
The feature revolves around the story of Dan Markingson, a 26-year-old in the throes of his first episode of psychosis. Considered by doctors to be a danger to others–he had threatened to slit his mom’s throat–and incompetent to make his own decisions regarding medications, Markingson was given a crazy choice. Option one: Be involuntarily committed to a state mental institution. Option two: Sign up to participate in an industry-sponsored study of antipsychotics that his industry-paid psychiatrist just happened to be running. (He signs up for the study and, predictably, tragedy strikes.)
So here is a patient who is judged incapable of making his own medical decisions yet able to give informed consent. A patient who is told that the only way to escape involuntary commitment is to participate in an experiment. Maybe my bioethics meter is out of whack but it all seems, you know, um, wrong.
It’s a whopper of a story, and I encourage you all to read it in full.
Additional Reading About the Dan Markingson Case
When Drug Trials Go Terribly Wrong: Lessons from a Bereaved Mother: Christopher Lane talks to Markingson’s mother.
Mary Weiss’ Troubling Loss: An editorial in the Minnesota Daily.
Lawyers, Drugs, and Money: Is Medical Research at the U of M Compromised?: Carl Elliot talks about the reaction to his story.