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Industry-backed research raises ethical concerns. (Evidence-Based Treatment?).

CHICAGO -- The domination of drug research by pharmaceutical companies poses an ethical dilemma for clinicians who want to provide state-of-the art care to their patients, Dr. Charles R. Goldman said at the American Psychiatric Association's Institute on Psychiatric Services.

"'Evidence-based treatment' is the new mantra. But how much can we trust evidence generated by commercially funded sources that are obligated to their stockholders to increase sales of their products?" said Dr. Goldman, professor of psychiatry at the University of South Carolina, Columbia.

Since passage of the federal Baye-Dole Act of 1980, aimed at promoting collaboration between academic and commercial interests, the role of drug companies in clinical research has increased dramatically: At the end of the 20th century, they were spending $3 billion per year to fund 70% of clinical trials in this country.

The involvement of manufacturers in drug research is not limited to financial support: Their employees often perform statistical analyses and then write the articles as well.

There is ample evidence that the source of funding influences study conception and design, analysis of data, and reporting of findings. "A company won't fund research that doesn't make its product look good," he said.

Some studies are narrowly focused to generate data that, though clinically meaningless, put the drug in question in a positive light. "A drug rep told me: 'If you want a result, fund a study. ... Studies are the best way to come up with advertising blurbs,'" Dr. Goldman said. It is not uncommon to see entire promotional brochures pieced together with bits and pieces of data from diverse papers that address minutiae of tolerability and efficacy.

One analysis of 70 published articles (about calcium channel blockers) found that an author who had a financial association with the manufacturer of the drug under investigation was more likely to take "a strong position" on the product's safety he said.

Even when studies are well designed, there is substantial bias in reporting: Findings that don't favor the sponsoring company s product are unlikely to be published. "When the 'evidence' you hear about is so highly selected ... it raises ethical questions about evidence-based treatment," he said.

A distortion that frequently occurs in the reporting of research is the discrepancy between the abstract that ostensibly summarizes and highlights findings, and the material in the body of the article. One study showed "gross inaccuracies" in the abstracts of 30%-68% of articles in six major journals.

The abstract of one article touted the economic benefits of an antipsychotic, stating "blatantly" that its use saved providers money But readers who looked closer at the article discovered that the finding was actually nonsignificant.

The manner in which research findings are disseminated further undermines attempts to consider evidence dispassionately Professional associations and meetings and the journals where results are reported are increasingly dependent on industry sponsorship.

Several years ago, Dr. Goldman said, he served on an APA committee to review industry-supported symposia for bias and balance. The consequence of such efforts is that "presenters have gotten cagier," he said: While avoiding blatant slanting of evidence, they now adopt such subtle ploys as applying different statistical standards to studies of the sponsor's drugs and those of other manufacturers.

The end-user of research, the psychiatrist who must decide which drugs to prescribe his patients, is put under direct pressure by promotional efforts: Pharmaceutical companies devote $11 billion yearly to market their products--roughly $10,000 per physician.
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Author:Sherman, Carl
Publication:Clinical Psychiatry News
Date:Nov 1, 2002
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