The New York Times - October 25, 2005
Nicholas Bakalar

The study, by the journal Nature and published in its Oct. 20 issue, found that more than one-third of the guideline authors acknowledged some financial interest in the drugs they recommended, including owning stock and being paid by the company to speak at seminars.

Almost half the published guidelines, the survey found, included no information about potential conflicts.

In half of the more than 200 guidelines examined, at least one author had received research financing from a relevant company, and 43 percent had at least one author who had been a paid speaker for the company.

Thirty-four percent of guidelines explicitly stated that their authors had no conflicts of interest at all.

The survey examined guidelines deposited last year with the National Guideline Clearinghouse, a database maintained by an agency in the Health and Human Services Department that summarizes and evaluates the documents. The database relies on the guideline authors for information about potential conflicts.

The survey cited clear instances of potential conflicts. Dr. Paul Volberding, a well-known AIDS researcher, led a panel that produced guidelines for the treatment of anemia in H.I.V.-positive patients. Ortho Biotech, the maker of the drug, organized the conference and paid the expenses for the panel.

According to the report in Nature, all six members of the group, including Dr. Volberding of the University of California, San Francisco, had previously accepted consulting or lecture fees from the company.

The guideline, published on May 14, 2004, in Clinical Infectious Diseases, recommends the use of epoetin alfa for H.I.V.-positive patients with anemia. It is distributed by Ortho Biotech under the brand name Procrit.

Dr. Volberding said in a telephone interview that the potential for bias always existed.

"It's appropriate to be cautious with any pharmaceutical company involvement in research or, certainly, in the publication of guidelines," he said.

Where a single company and a single product are involved, he added, "caution should increase."

"It can be addressed to some degree with full disclosure of the relationship to the company," he continued. "There would be serious concern if this were in any way hidden."

The anemia guideline specifies that the group's consensus conference was "supported by an educational grant from Ortho Biotech," but it does not mention company payments to individual members.

Practice guidelines, written by ad hoc groups, specialty societies, companies and governmental agencies, have become important in recent years because of the demand for "evidence based" practices based on expert opinion and the results of clinical studies.

The American College of Obstetricians and Gynecologists publishes a guideline on inducing labor, and the American Psychiatric Association publishes one for treating schizophrenia. Kaiser Permanente, the health management organization, publishes a lengthy guideline on treating diabetes.

Dr. David A. Kahn, a professor of psychiatry at Columbia who has worked on several industry-financed guidelines, said he shared Dr. Volderbing's confidence that industry sponsorship did not necessarily lead to bias.

"Some of the funding was simply good will by companies with no strong link to any product likely to be highly recommended," Dr. Kahn said. "In other cases, the outcomes could be guessed at in advance based on known clinical evidence and anticipated sentiment, and the funding was designed to promote expected good news rather to influence its creation."

In any case, Dr. Kahn said, researchers are generally "making the best of a funding system controlled mostly by commercial enterprise."

"That's the market-driven system the American people have chosen to live within, and it has its pros and cons," he continued.

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