In an editorial in the April 16 issue of JAMA, Catherine D. DeAngelis, M.D., M.P.H., Editor in Chief, and Phil B. Fontanarosa, M.D., M.B.A., Executive Deputy Editor, JAMA, comment on the studies in the April 15 issue of JAMA documenting the apparent misrepresentation of research data by one company and its manipulation of clinical research articles and clinical reviews.
"What are the lessons from the 2 articles in this issue of JAMA, from other publications that have examined related issues, and from extensive experience with how clinical research has been manipulated by for-profit companies? First, manipulation of studies and misrepresentation of study results could not occur without the cooperation (active and tacit) of clinical researchers, other authors, journal editors, peer reviewers, and the Food and Drug Administration (FDA)."
"Second, public trust for clinical research is in great jeopardy especially when the extent of how widespread such practices have become is unknown. Although we truly believe that the vast majority of researchers and other authors are honest and have the highest scientific integrity, manipulation of studies and publications by the pharmaceutical and medical device industries is either increasing or there has been more exposure of these practices."
"Third, in addition to clinical research, clinical practice and medical education also are greatly influenced by for-profit companies. Drastic action is essential, and cooperation of everyone involved in medical research, medical editing, medical education, and clinical practice is required for meaningful change to occur."
Drs. DeAngelis and Fontanarosa propose the following:
- All clinical trials must be prospectively listed in registries accepted by the International Committee of Medical Journal Editors (ICMJE) prior to patient enrollment, and the name(s) of the principal investigator(s) should be included as a required data element in the trial registration record.
- All individuals named as authors on articles must fulfill authorship criteria. Journals should require each author to report his or her specific contributions to the article, and should consider publishing these contributions.
- All journals must disclose all pertinent relationships of all authors with any for-profit companies, and must publish all funding sources for each article.
- Journal editors must seriously consider funding sources and authors' disclosed financial conflicts of interest and financial relationships when deciding whether to publish a study or review.
- For-profit companies that sponsor biomedical research studies should not be solely or primarily involved in collecting and monitoring of data, in conducting the data analysis, and in preparing the manuscript reporting study results.
- All journals must require a statistical analysis of clinical trial data conducted by a statistician who is not an employee of a for-profit company.
- Any author who fails to disclose financial relationships or other conflicts of interest, or who allows his or her name to be used for work that he or she did not actually perform, must be reported to the appropriate authority (i.e., medical school dean or department chair) or appropriate oversight body.
- Any peer reviewer who provides any confidential information, such as a manuscript under review, to any third parties, such as for-profit companies, or who engages in other similar unethical behavior, also should be reported to the appropriate authority (e.g., medical school dean) or oversight body, and should be banned from reviewing and publishing articles in that journal.
- Any editor who knowingly allows (or is party to allowing) for-profit companies to manipulate his or her journal must be relieved of the editorship.
- To maintain a healthy distance from industry influence, professional organizations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials or providing funding or sponsorship for medical education programs.
- Individual physicians must be free of financial influences of pharmaceutical and medical device companies including serving on speaker's bureaus or accepting gifts.
"When integrity in medical science or practice is impugned or threatened--such as by the influence of industry--patients, clinicians, and researchers are all at risk for harm, and public trust in research is jeopardized. Ensuring, maintaining, and strengthening the integrity of medical science must be a priority for everyone," they conclude.
Journal reference: JAMA. 2008;299:1833-1835. A
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