Drug Companies Influence Medical Research

By ALICIA CHANG

Many U.S. medical schools are willing to give companies that sponsor studies of new drugs and treatments considerable control over the results, according to survey results that some doctors found troubling.

Half of the schools said they would let pharmaceutical companies and makers of medical devices draft articles that appear in medical journals, and a quarter would allow them to supply the actual results. But academics draw the line at gag orders that keep researchers from publishing negative findings.

"This is totally beyond reasonable practice. What you're seeing here is a willingness by some institutions to give more leeway than they should," said Dr. Harlan Krumholz, a Yale University cardiologist and epidemiologist who was not involved in the survey.

Private industry funds more than two-thirds of medical research at U.S. universities, a situation that has led increasingly to conflict-of-interest suspicions. Two decades ago, the federal government was the main benefactor.

The study, led by Michelle Mello of the Harvard School of Public Health, appears in Thursday's New England Journal of Medicine.

Harvard researchers sent surveys to the nation's 122 accredited medical schools to gauge what kinds of standards exist between researchers and sponsors. All but 15 responded.

The researchers did not directly establish exactly how much control universities actually give to companies.

But the medical schools overwhelmingly agreed that they would not enter into contracts that would allow companies to edit research articles or suppress negative results. The schools were split on other issues. Fifty percent would allow companies to draft research papers, while nearly 25 percent would let them provide the data.

Three-fourths had disputes over payment after a contract was signed, and 17 percent argued over access to data.

"These results are really bothersome," said Dr. Jerome Kassirer, former editor in chief of the journal and author of a recent book about conflict of interest in research. "Some investigators may be willing to accept constraints just to maintain good relations with the company," said Kassirer, who had no role in the survey.

The Pharmaceutical Research and Manufacturers of America, a trade group, insists that corporate sponsors do not interfere with researchers' independence.

The group publishes voluntary research guidelines stating that companies will sometimes help analyze and interpret results and have the right to review articles before publication. The guidelines also note that sponsors own the data and have sole discretion over who has access to the information.

Recent controversies involving companies accused of suppressing unfavorable results have led to demands for more public disclosure of industry-sponsored research. Drug manufacturers GlaxoSmithKline and Merck were recently accused of hiding information about the antidepressant Paxil and the painkiller Vioxx, respectively.

An accompanying editorial noted several efforts under way to change the situation, among them:

• The American Medical Association is working with the industry to eliminate gag clauses in research contracts.
• The Association of American Medical Colleges is developing a set of principles for researchers and sponsors of studies.
• A bill is pending in Congress that would require public and private sponsors to register their studies in a government database.
• Eleven members of the International Committee of Medical Journal Editors last year promised not to publish any studies not registered in the database.

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On the Net: New England Journal of Medicine: http://content.nejm.org

Harvard School of Public Health: http://www.hsph.harvard.edu

Government clinical trials page: http://www.clinicaltrials.gov

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