Healthy Skepticism Library item: 2474

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

Davidoff F.
Between the lines: Navigating the uncharted territory of industry-sponsored research: A former medical journal editor describes how and why staff changed their policy on disclosing conflicts of interest.
Health Affairs 2002 Mar-Apr; 21:(2):235-242
http://www.medscape.com/viewarticle/429526

Abstract:

In 1995 the report of a large industry-supported drug trial submitted to the Annals of Internal Medicine forced a rethink of journal policy on disclosing conflicts of interest. Although the report acknowledged sponsorship, it did not state the sponsor’s involvement in and control over research being done by an ‘independent’ investigator. The editors concluded that they had an obligation to improve disclosure of conflicts of interest and other nontechnical factors that could affect research conduct and reporting. There are similarities between clinical research and continuing medical education (CME). Both involve three main entities: (1) the research project or educational program, (2) the researchers or CME faculty, and (3) the readers or CME attendees. Drug companies are required to demonstrate both safety and efficacy of drugs, which is demanding and expensive, potentially causing tension between independent researchers and sponsors. The Annals’ new policy asked authors to disclose details of the sponsor’s role in the study. It also requested information about financial interests ‘dual commitment’ in the manuscript itself so that reviewers were aware of it. Since 1997, the Uniform Requirements for Manuscripts Submitted to Biomedical Journals have changed significantly along the lines of those adopted by the Annals. Disclosure is a powerful tool, but it is a surrogate for scientific truth, and it has no real teeth. It can be self-defeating if it requires excessive bureaucracy and generates irrelevant information. Nevertheless, disclosure is an important measure of social control in clinical research.

Keywords:
*analysis United States relationship with pharmaceutical industry conflict-of-interest dual commitment continuing medical education ETHICAL ISSUES IN PROMOTION: MEDICAL JOURNAL EDITORSHIP PROMOTION DISGUISED: CLINICAL TRIALS PROMOTION DISGUISED: DISINFORMATION AND HARASSMENT REGULATIONS, CODES, GUIDELINES: JOURNALS AND MASS MEDIA SPONSORSHIP: RESEARCH