Journals aim to curb drug industry sway over studies

Medical journals plan to unveil a new policy to limit drug companies' control of research.

By Damon Adams, amednews staff. Sept. 3, 2001.

Major medical journals want to keep drug companies from exerting too much influence over research studies. This month the journals will publish new rules that give final say over the results of medical studies to researchers -- instead of drug companies that fund the research.

The policy will give the editors of journals the right to reject studies unless researchers are granted adequate independence.

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"No one should have a problem with this if people are doing what they're supposed to be doing," said Catherine DeAngelis, MD, MPH, editor of the Journal of the American Medical Association. "All we're doing is making people adhere to our routine rules and regulations."

JAMA, the New England Journal of Medicine, The Lancet and Annals of Internal Medicine are among the journals that will publish the new policy in mid-September. Editors agreed to the rules at the International Committee of Medical Journal Editors' annual meeting in May in Philadelphia.

Editors said they grew more concerned about drug company-sponsored research after cases in which companies tried to withhold results or present them to favor certain drugs.

"It's an utterly serious matter when any part of the health care system withholds information that could be helpful to patients and doctors in deciding what to do," said Harold Sox, MD, editor of the Annals of Internal Medicine. "To do that deliberately is wrong."

Pharmaceutical Research and Manufacturers of America, a group that represents drug companies, sees no reason for new guidelines.

"It's not a major crisis. We think they're overexaggerating the problem," said PhRMA spokesman Jeff Trewhitt.

"In the vast majority of cases, these are scientifically sound studies," Trewhitt said.

Drug companies usually pay university researchers or their institutions to do medical studies. Researchers seem to conduct their work independently of drug firms and write about conclusions based on data.

But, editors say, drug companies may collect and analyze the data, then write up the findings. That bothers some editors who consider publishing the results.

"There has to be a level of trust," Dr. DeAngelis said.

Recent examples

Eroding much of that trust have been several incidents involving published studies.

Last year, JAMA ran a study on Celebrex only to learn later that half a year's worth of data wasn't included, giving the drug a better showing than if all the data had been presented.

Also last year, University of California at San Francisco researchers published results that Remune, a new AIDS treatment, failed to benefit patients. The product's maker sued.

Amid such problems, JAMA in July added a policy that calls for authors to report all financial and material support for their research.

The new rules will guarantee independence to researchers, editors said.

"If we all stick to the same rules, that gives the authors some real power in negotiating contracts with the pharmaceutical companies," Dr. DeAngelis said.

Trewhitt said drug companies also value credibility, and it doesn't benefit them to present bad data.

"A company cannot afford to have its reputation damaged with doctors, patients and the Food and Drug Administration," he said. "There are product liability concerns if something really, really goes wrong and you end up with a lot of lawsuits."

By embracing new policies on drug company-sponsored studies, journal editors pointed out that they would give their readers truthful and reliable information.

"We all believe that the public needs an accurate account of the effectiveness of drugs and the safety of drugs so that they can make intelligent decisions about which drugs they should use," Dr. Sox said.