Healthy Skepticism Library item: 4228

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

Shimm DS, Spece RG Jr.
Industry reimbursement for entering patients into clinical trials: legal and ethical issues.
Ann Intern Med 1991 Jul 15; 115:(2):148-51

Abstract:

Pharmaceutical manufacturers commonly contract with clinical investigators for pre-market testing of new products. The per-patient reimbursement offered to the investigator generally exceeds the per-patient costs incurred by the investigator. This excess represents a windfall that can be used to pay for travel, equipment, or supplies, or to fund research for which the investigator cannot obtain funding through peer-reviewed granting channels. This excess raises a potential conflict of interest, because it may lead the investigator to propose experimental treatment for a patient when the patient might be better served by conventional treatment or by no treatment at all. Not only does this situation pose a conflict of interest, it also is a conflict of which few patients are aware and fewer are informed. We propose that all experimental subjects be informed of the source, amount, and mechanism of funding for the experimental treatments they undergo. Further, we propose that payments from pharmaceutical manufacturers for pre-market testing of drugs go to the medical school dean rather than to the individual investigator. With this money, the dean can defray the direct as well as the indirect costs of the clinical study; the remainder, which would otherwise go directly to the investigator, should be placed in a funding pool for which the entire medical school could compete. This solution largely eliminates conflict of interest, addresses informed consent, and reasonably balances the interests of the experimental subject, the clinical investigator, the pharmaceutical manufacturer, and the academic institution.

Keywords:
*analysis/drug company sponsored research/conflict of interest/reimbursement to doctors/patients/clinical trials/ETHICAL ISSUES IN PROMOTION: PAYMENTS IN STUDIES/SPONSORSHIP: RESEARCH Biomedical Research* Clinical Trials/economics* Clinical Trials/legislation & jurisprudence Clinical Trials/standards Conflict of Interest*/legislation & jurisprudence Disclosure* Drug Industry/economics* Informed Consent/legislation & jurisprudence Research Personnel/economics* Research Personnel/legislation & jurisprudence Research Personnel/standards Research Subjects* Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S. Therapeutic Human Experimentation United States