Forty years ago, when most clinical research took place in academic settings, the main dangers to research subjects came in service to genuine scientific aims. A large regulatory apparatus was developed to protect human subjects from the ambitions of overweening academic researchers. In the early 1990s, however, pharmaceutical companies realized that it was faster and less expensive to conduct trials in the private sector, where the driving force is not knowledge, but profit. And the regulatory apparatus designed for the old era has proved woefully inadequate for the new one.
UD‘s friend Carl Elliott, in today’s New York Times, warns about the disintegration of legitimate research, and the harm that can come – under a new commercial regime – to human subjects.
July 29th, 2011 at 10:43AM
Carl Elliott’s OpEd in yesterday’s New York Times is right on target. He explains what happens when marketers rather than physicians conceive and direct clinical trials, when patients are viewed as commodities, and when clinical investigators are treated as enablers. And it doesn’t just involve seeding trials. Some of our most visible academic institutions have eaten at the Pharma trough as partners in trials that were nothing more than strategic marketing exercises. Back in 2004 I introduced the term experimercial for these commercially motivated clinical trials.