Healthy Skepticism Library item: 3032

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

Hemminki E.
Study of information submitted by drug companies to licensing authorities.
Br Med J 1980 Mar 22; 280:(6217):833-6

Abstract:

Reports of clinical trials included in applications submitted by drug companies to licensing authorities in Finland and Sweden in four different years were studied. Many reports were submitted, but most of the trials were uncontrolled and of poor quality. Many of the reports were unpublished, and thus, as the submissions are secret, were not available to doctors. These unpublished reports were in most respects as valuable as the published reports. Most of the reports included some information about adverse effects; the information was often deficient, but skilled analysis might increase its value. This study provides support for those who want to see public disclosure of the reports of trials submitted in licensing applications.

Keywords:
*systematic review/Finland/Sweden/ reporting of results/ regulatory authorities/ new drugs/ drug company sponsored research/psychotropic drugs/quality of information/INFORMATION FROM INDUSTRY: REGULATORY AUTHORITIES/SPONSORSHIP: RESEARCH Clinical Trials* Comparative Study Drug Industry* Drug and Narcotic Control* Finland Humans Licensure* Psychotropic Drugs/adverse effects Sweden