Privatizing clinical trials
Posted by Henry Bauer on 2010/03/01
From a review (“Neoliberal medicine”, by Nina Ayoub, Chronicle of Higher Education, 13 February 2009, p. B19) of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials (by Jill Fisher, Rutgers University Press; Fisher is at the Center for Biomedical Ethics & Society at Vanderbilt University):
About ¾ of clinical drug trials are now done by practicing physicians who recruit their own patients or other local people. Around 2001-3, 50,000 physicians were registered as principal investigators on such trials, and >3.5 million Americans were research subjects. Fisher ascribes the rise in such research to fiscal pressures on both physicians and the public: people who cannot afford health insurance and health-care welcome such trials as a way of possibly getting treatment. Drug companies find the arrangements desirable because they can be carried out faster than through academic research where institutional review boards can be typically slow-moving.
Ironically, those who become research subjects because they cannot afford health care will then be unable to afford treatment with the drugs they helped to get approved. Conflicts of interest seem even worse here than in clinical trials in general. There’s always a dilemma between the Hippocratic injunction to do the best possible for a patient and the desirability in clinical trials of having a placebo group as controls. For example, a physician testing an obesity drug cannot recommend diet and exercise when the drug needs to be tested in absence of concomitant lifestyle changes. “Uninsured middle-class white women are the most common subjects for efficacy trials that require people with a given condition to test a new drug or do comparison studies. Low-income minority men . . . are the main source for healthy-subject trials that test the toxicity of new drugs and involve higher stipends but higher risks”.
Fisher also points out that “informed consent” does not amount to being given good advice about what is involved.