Guinea-pigging Up Close and Personal

Carl Ellioitt of the University of Minnesota Center for Bioethics has just published an insightful article in the New Yorker about Phase 1 research: “

Professor Elliott mentions my work at the firm and includes a quote: “This is not something you or I do. This is something the poor do so the rich can get better drugs.”

One of the great myths of human research is that the subjects are motivated by an altruistic belief in the greater good. As the article points out, the truth is that most subjects in Phase 1 research are motivated by the same thing that motivates many of the researchers: money. This recognition doesn’t have to mean that the system is corrupt and needs to be halted, and the article does not advocate for such a position. Medicine and science could not advance without the availability of such human subjects.  What it does mean is that more oversight is needed to make sure such research is conducted safely and that the researchers understand their ethical and legal obligations.

A similar reality check is necessary in Phase 2 and 3 therapeutic research. Altruism rarely is the motivating factor for participation. What the subjects usually want is just to get well and they agree to participate because they think the research is in their best therapeutic interest. Again this does not mean the research enterprise is corrupt or unethical. But it does require more oversight on the part of the FDA and OHRP to make sure both researchers and research subjects understand their roles in the search for new cures and medical advances.

Alan Milstein