Medical journals act to limit drug firms' influence


WASHINGTON (Reuters) – Seeking to curb the growing influence exerted by drug firms over research findings, the world's top medical journals announced steps on Sunday to prevent firms that fund studies from manipulating results to favor their drugs or bury studies that are unfavorable.

The policy, which was first reported by Reuters Health on August 6, seeks to guarantee that companies that are bankrolling the research permit the scientific independence of investigators involved in the study.

A dozen journals in eight countries–including the Journal of the American Medical Association (JAMA), The New England Journal of Medicine, The Lancet and the Annals of Internal Medicine–unveiled uniform requirements for studies submitted for publication.

"No pharmaceutical company that is straightforward and honest and would not want to manipulate data would have any problem with this," Dr. Catherine DeAngelis, JAMA editor, told Reuters.

An editorial being published by the participating journals on Monday stated that "corporate sponsors have been able to dictate the terms of participation in the trial, terms that are not always in the best interests of academic investigators, the study participants or the advancement of science in general. Investigators may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation."

"Unfortunately, even when an investigator has had substantial input into the trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavorable to the sponsor's product," the editors stated.

Many of the journals will now mandate that scientists submitting a study for publication sign a statement indicating they take full responsibility for the findings, had access to the data and controlled the decision to publish. "We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication," the editors said.

The journal editors said they were spurred into action by several examples in recent years of drug companies being accused of attempting to hide findings that were not to their liking or misrepresenting such results as positive. The editorial said the use of medical studies "primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool."

An industry spokesman responded cautiously. Dr. Bert Spilker, senior vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers Association of America said the editors "have every right to establish these policies for their journals."

Dr. Spilker said that "in the interests of scientific integrity and patient safety," academic researchers must have complete freedom to take part in and approve all aspects of a study, including publication decisions. However, last month, Dr. Spilker called the editors' concerns "patently absurd."

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