Medical journals crack down on industry influence over published studies.

The editors of 12 prominent medical journals have joined forces to combat what they say is a dangerous increase in pharmaceutical companies' control over clinical research and how peer-reviewed publications report study results.

Their concern echoes that of plaintiff attorneys handling pharmaceutical products liability cases, who assert that many studies touting drugs' safety and efficacy are tainted by manufacturer influence over clinical trials.

In a recent editorial published in the 12 journals, the editors announced that they had adopted a joint policy aimed at reducing the drug industry's influence over how scientific research is conducted and reported. Too often, according to the editors, companies that underwrite studies of their own drugs dictate to researchers how the studies are to be done and whether or what data are reported.

Authors of clinical trial studies "may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation," the editors wrote. The result? Many drugs on the market may not be as safe or as beneficial as indicated by the published studies--which drug manufacturers often use to defend claims that their products are defective.

Under the new policy, potential authors of articles that explain the results of clinical studies may have to confirm in writing that they bear ultimate responsibility for how the research was conducted, had access to all the data, and had control over whether and when the results would be published. (See Frank Davidoff et al., Sponsorship, Authorship, and Accountability, 345 New Eng. J. Med. 825 (2001).)

Among the publications adopting the policy are some of the most highly respected medical journals, including the New England Journal of Medicine, the Journal of the American Medical Association (JAMA), the Lancet, and the Annals of Internal Medicine. By acting jointly to enforce adherence to the new rules, the journal editors hope to assure "readers that the authors of an article have had a meaningful and truly independent role in the study that bears their names."

Concern over industry influence has been growing since the mid-1980s, said Sheldon Krimsky, a professor of urban and environmental policy and planning at Tufts University. He is the author of a recent study showing that scientists who publish their research results rarely divulge their financial ties to industry. (Undisclosed Industry Ties of Scientific Authors Undercut Credibility, TRIAL, July 2001, at 16.)

Krimsky said that Arnold Relman, a former editor of the New England Journal of Medicine, wrote in 1984 that entrepreneurism was rampant in medicine, "and he made a very persuasive argument back then."

As the cost of getting a drug to market in the United States has increased--averaging about $500 million, according to one report--the pharmaceutical industry has taken a leading role in funding biomedical research. This, coupled with competition between academic and private researchers for opportunities to conduct clinical trials, has allowed corporate sponsors to "dictate the terms of participation in the trial[s], terms that are not always in the best interests of academic investigators, the study participants, or the advancement of science generally," the journal editors wrote.

In one highly publicized case, Immune Response Corp. tried to block publication of a study showing that its AIDS-therapy drug Remune did not help patients who were already receiving standard treatments. The study, by researchers at the University of California at San Francisco, was published in JAMA last year. The company recently dropped a lawsuit seeking damages from the university for breach of contract.

In 1998, a Canadian doctor, Nancy Olivieri, lost research funding when she published findings in the New England Journal of Medicine that raised questions about the safety of a drug made by Apotex, Inc., to treat certain rare blood disorders like sickle cell anemia. The drug company has threatened to sue Olivieri for violating a confidentiality agreement.

These widely publicized cases probably represent the tip of the iceberg, according to the journal editors. "There have been a number of recent public examples of such problems, and we suspect that many more go unreported," they wrote.

Krimsky called the new publication policy a "favorable outcome in response to a serious concern about the imbalance in control of research data." But he said more needs to be done to ensure the integrity and independence of medical research.

This list of 12 represents a very small number of the total number of medical journals. While the list contains some of the most media-visible journals," he said, some other frequently cited medical journals are not on the list. "Unless other journals adopt similar policies, it may simply be that we have just a small number of journals leading the way."