Healthy Skepticism Library item: 6950

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

Bellin E.
Clinical investigators and the pharmaceutical industry.
N Engl J Med 2000 Aug 17; 343:(7):511
http://content.nejm.org/cgi/content/full/343/7/510

Abstract:

I suggest three remedies to the problems identified by Dr. Bodenheimer. First, require all trials undertaken by pharmaceutical companies to be registered with the FDA, with end points specified in advance. Failure to register studies in advance would make their results inadmissible as evidence in FDA studies of efficacy. Second, make the pharmaceutical companies fill out a trial-completion report on all drugs they have studied. Third, require the pharmaceutical companies to make the data from their trials available on a Web site for others to analyze. Appropriate means of protecting the subjects’ confidentiality would be expected. Making the raw data available will allow others to analyze in depth the results of studies that the companies have chosen to ignore. (full text)

Keywords:
*letter to the editor/United States/relationship with pharmaceutical industry/conflict-of-interest/bias/SPONSORSHIP: RESEARCH Clinical Trials/standards* Conflict of Interest/economics Drug Industry/standards* Research Support* United States United States Food and Drug Administration