Healthy Skepticism Library item: 16758

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Egilman D
Just say no
BMJ 2009; 339:b4527
http://www.bmj.com/cgi/content/short/339/nov02_2/b4527?rss=1

Abstract:

The postmarketing observational studies referred to by Annette Tufts in her news story are sham studies that are generally referred to as “seeding trials.“1 2 The actual research taking place is the evaluation of the return on investment (ROI) from paying physician “investigators” to participate in the sham study. The ROI is measured by tracking the increased use of the drug by participating doctors, who are the real subjects of these studies.3

No patient would ever agree to participate in a trial designed to determine how the use of physicians as investigators can increase drug sales. No institutional review board would ever approve such a trial. Unfortunately, the side effects from these sham trials are real.4

Drug companies are systematically misleading patients and doctors in these seeding trials. The Nuremberg Code (and all other medical research codes) requires that research subjects should be informed of the purpose of the research. This . . .