Medical journals set new rules

November 1, 2001

Pharmaceutical Representative

Thirteen editors of some of the world's most influential medical journals have announced that they will be developing new standards to address possible conflicts of interest between journal authors and third-party groups like drug companies and medical device manufacturers.

Thirteen editors of some of the world's most influential medical journals have announced that they will be developing new standards to address possible conflicts of interest between journal authors and third-party groups like drug companies and medical device manufacturers. The plan was revealed in a joint editorial that ran in the Journal of the American Medical Association (vol. 286, no. 10).

"Clinical trials are powerful tools; like all powerful tools, they must be used with care," read the editorial. "Well-done trials published in high-profile journals may be used to market drugs and medical devices, potentially resulting in substantial financial gain for the sponsor. Patients participate in clinical trials largely for altruistic reasons - that is, to advance the standard of care. In the light of that truth, the use of clinical trials primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool."

Rule revisions

As a result of these concerns, the editors have revised the "Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication," a document developed by the International Committee of Medical Journal Editors and widely used by medical journals as the foundation for their editorial policies.

The revised rules will require authors to disclose any potential conflicts of interest when their articles are submitted. Authors may also be required to sign a statement saying that they had full access to all the data in the study.

"As part of the reporting requirements, we will routinely require authors to disclose details of their own and the sponsor's role in the study," the authors wrote. "Many of us will ask the responsible author to sign a statement indicating that he or she accepts full responsibility for the conduct of the trial, had access to the data, and controlled the decision to publish."

Industry support

The pharmaceutical industry has expressed support for the new requirements. "In the interests of scientific integrity and patient safety, it is essential that academic researchers who participate in clinical trials have complete freedom to participate in and approve all aspects of a trial, including any publication that may result from such a trial," said Bert Spilker, senior vice president for scientific and regulatory affairs for the Washington-based Pharmaceutical Research and Manufacturers of America. "We agree that the editors and their publishers have every right to establish these policies for their journals. We respect their rights and encourage all authors to abide by their rules regardless of their affiliation." PR