Healthy Skepticism Library item: 5514

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

Stephens MD.
Marketing aspects of company-sponsored postmarketing surveillance studies.
Drug Saf 1993 Jan; 8:(1):1-8

Abstract:

Most clinical studies in which a patient receives a newly marketed drug have some marketing advantages, intended or otherwise. A clinical study may be monitored by a sales representative and a friendly relationship ensue such that the representative will have easy access to the physician in the future. The results of a postmarketing surveillance (PMS) study may encourage a company to make additional claims in its advertising. Some uncontrolled cohort studies were and are planned more for their marketing advantage than for the detection of adverse drug reactions and these are called “seeding” studies. Quadripartite guidelines for PMS studies were drawn up to stop seeding studies and promote those with scientific value. The four organizations that participated in developing these guidelines were: Association of the British Pharmaceutical Industry, British Medical Association, Committee on Safety of Medicines and the Royal College of General Practitioners. The Medicines Control Agency reviewed 31 PMS studies conducted under the Quadripartite guidelines and concluded that company PMS studies had made only a limited contribution to the assessment of drug safety, principally because of weak study designs and difficulties in recruitment.

Keywords:
Drug Industry* Humans Marketing of Health Services* Product Surveillance, Postmarketing* *analysis/*policy statement & guideline/United Kingdom/postmarketing research/Quadripartite policy statement & guidelines/drug company sponsored research/seeding studies/safety & risk information/regulation of promotion/British Medical Association/Committee on safety & risk information of Medicines/ABPI/ Association of the British Pharmaceutical Industry/ Royal College of General Practitioners/EVALUATION OF PROMOTION: DRUG SAFETY/PROMOTION DISGUISED: POSTMARKETING RESEARCH/REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS/REGULATION, CODES, GUIDELINES: POSTMARKETING RESEARCH/SPONSORSHIP: RESEARCH