Medical Journals Act to
Limit Drug Firms' Influence
Excerpt By Willam Dunham, Reuters Health

WASHINGTON (Reuters) - Seeking to curb the growing influence of drug firms on research, 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.

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

The policy seeks to guarantee that companies that are bankrolling the research permit the scientific independence of investigators involved in the study.

``No pharmaceutical company that is straightforward and honest and would not want to manipulate data would have any problem with this,'' Dr. Catherine DeAngelis, editor of the Journal of the American Medical Association, told Reuters.

An editorial published by the participating journals on Monday said 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.''

``And, 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 now will 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.

COMPANIES WANT PRESTIGIOUS BACKING

Drug companies have emerged as the primary financial backers of biomedical research, especially as it relates to the large, expensive clinical trials that judge a drug's safety and effectiveness. These firms crave publication in a prestigious journal because physicians rely on these types of published studies to decide whether to prescribe a particular drug.

The scientist advertised as the lead author of a given study often is a university professor, but the study frequently has been funded, designed and carried out by a company with a massive financial interest in the findings. The average cost of bringing a new drug to market in the United States is estimated to be $500 million.

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.''

``It is our increasingly common experience that we see research papers that manipulate results in favor of new products--both drugs and devices,'' Richard Horton, editor of the British journal Lancet, said in an interview. ``There is an unresolvable conflict between the commercial interest of the company and the interests of patients and doctors who want to conduct independent research.''

DeAngelis added, ``I am not against the pharmaceutical companies. I love them. That's not the issue. The issue is, in some cases, when they do these clinical trials, they control the data. They analyze the data. In some cases, they even write the article. And that leads to at least the perception, if not the reality, that there's a conflict of interest.''

Dr. Harold Sox, editor of the Philadelphia-based Annals of Internal Medicine, said the editors hope the new policy will give more leverage to scientists as they negotiate the terms for research. ``We think it's going to help. I don't think any of us are naJive enough to think it's going to solve the problem,'' Sox told Reuters.

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.''

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. Only last month, Spilker called the editors' concerns ``patently absurd.''

The participating journals are published in Australia, Britain, Canada, Denmark, New Zealand, Norway, the Netherlands and the United States.

Reference Source 89

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