Healthy Skepticism Library item: 5249

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

Ray WA, Griffin MR, Avorn J.
Evaluating drugs after their approval for clinical use.
N Engl J Med 1993 Dec 30; 329:(27):2029-32

Abstract:

(Limited to parts of article dealing with promotion.) Industry sponsored research on drugs after their clinical approval does not necessarily address many important clinical and policy questions. Studies may use the wrong comparison drugs or doses of comparison drugs that are inappropriate. Manufacturers also would not benefit from studies to determine whether inexpensive, off-patent drugs or nonpharmaceutical interventions could replace profitable, single-source products or from studies to determine the rates of adverse reactions to approved products.

Keywords:
*analysis/postmarketing research/drug company sponsored research/safety & risk information/PROMOTION DISGUISED: POSTMARKETING RESEARCH/SPONSORSHIP: RESEARCH Adverse Drug Reaction Reporting Systems/standards* Aged Drug Therapy/standards* Evaluation Studies Humans Prescriptions, Drug/standards* Product Surveillance, Postmarketing Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S. United States United States Food and Drug Administration