Useless Studies, Real Harm

Carl Elliott teaches bioethics at the University of Minnesota and is the author of “White Coat, Black Hat: Adventures on the Dark Side of Medicine,” has an Op-Ed post in the today's New York Times. Professor Elliot offers insight into the lack of Human Research Protection for participants in research, paritcularly in"seeding trials." These "seeding trials" he explains, are used as a marketing tactic; they are not drug trials that are conducted not to advance research, but are conducted solely for the purpose of increasing the market for the particular drug which is being trialed.
     
a couple of excerpts:"How can studies that endanger human subjects attract so little scrutiny? 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.

"The main source of protection for research subjects is a patchwork system of ethics committees known as institutional review boards, or I.R.B.’s. These are small, federally empowered bodies that review research proposals before they are carried out, to ensure that the studies are ethically sound. But they don’t typically pass judgment on whether a study is being carried out merely to market a drug. Nor do most I.R.B.’s have the requisite expertise to do so. Even worse, many I.R.B.’s are now themselves for-profit businesses, paid directly by the sponsors of the studies they evaluate. If one I.R.B. gets a reputation for being too strict, a pharmaceutical company can simply go elsewhere for its review." (emphasis mine) here 

I would only add that I.R.B's not only lack expertise, but seem to also lack familiarity with or understanding of the Nuremberg Code

Thank You Carl Fear and Loathing in Bioethics