Healthy Skepticism Library item: 3466

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

Spitzer WO, Hutchinson T, Lane D.
Postmarketing management of drug use: toward rational public policy.
CMAJ 1987 May 15; 136:(10):1022-4

Abstract:

A conference on public health issues in the use of drugs reached the conclusion that the topic is sufficiently broad that it justifies a whole new concept that was labeled postmarketing management of drug use. Postmarketing management decisions should always be preceded by the scientific assessment of their likely health effects and this assessment should takeplace in an environment as free from political pressures as possible. Rather than banning drugs, agencies concerned with postmarketing management should instead carry out programs that promote the use of available agents in the most effective possible ways and discourage their use when they are contraindicated for particular patient populations. One of the criticisms of the process and its conclusions was that it was unbalanced. No active members of national regulatory or monitoring agencies participated in the proceedings whereas the conference was funded by seven pharmaceutical companies who sent representatives who participated in its deliberations. There was also nothing said of the responsibility of industry for its actions in making drugs available, educating prescribers about their proper use, gathering information about risks and benefits and deciding whether to withdraw drugs from the market.

Keywords:
*editorial/ postmarketing research/ regulatory authorities/ safety & risk information/ drug company sponsored guidelines/PROMOTION DISGUISED: PHYSICIAN EDUCATION MATERIAL AND GUIDELINES Canada Evaluation Studies* Humans Pharmaceutical Preparations* Product Surveillance, Postmarketing*