U.S. Congress probes researchers & big pharma

Congress to Probe Policies at NIH
A bipartisan group asks the health agency for details of a researcher's ties to drug companies to assess its conflict-of-interest guidelines.

By David Willman, Times Staff Writer
August 10, 2006

WASHINGTON — A bipartisan group of congressional leaders has asked the director of the National Institutes of Health to provide details of a senior researcher's ties to several pharmaceutical companies.

The congressional leaders, including the Republican chairman and the ranking Democrat of the House Energy and Commerce Committee, said in their letter that they wanted the details in order to evaluate conflict-of-interest policies at the NIH. They requested a response by week's end.

"We have received the letter, and NIH will be responding to the committee," NIH spokesman Donald Ralbovsky said Wednesday.

The senior researcher, Dr. Thomas J. Walsh of the National Cancer Institute, helped lead clinical trials that used the companies' drugs to treat suspected fungal infections in patients with compromised immune systems. Walsh also appeared alongside company representatives at various U.S. Food and Drug Administration meetings regarding antifungal products made by the companies.

Two of the companies, Pfizer Inc. and Merck & Co., have acknowledged paying Walsh fees in recent years.

According to the congressional letter, the Energy and Commerce Committee "is seeking to determine if there is a sufficient factual basis to formally investigate questions about National Institutes of Health policy, the adequacy of NIH oversight or other issues that may be raised by the conduct of this NIH scientist."

The July 28 letter was signed by Rep. Joe L. Barton, R-Texas, the committee's chairman; Rep. John D. Dingell, D-Mich., the ranking Democrat; Rep. Edward Whitfield, R-Ky., the chairman of the panel's Oversight and Investigations Subcommittee; and Rep. Bart Stupak, D-Mich.

The letter was prompted by articles published July 16 by the Los Angeles Times, which reported Walsh's appearances with the companies at the FDA meetings, his acceptance of fees from Merck and Pfizer, and his leadership role with the clinical trials.

Walsh's fees were not among the industry payments reported by the NIH to the congressional committee two years ago, when the panel first examined potential conflicts of interest among agency scientists.

The Times also reported that, when results of two of the clinical trials were published in 1999 and in 2004, controversy flared as other scientists questioned whether dosages of "control" drugs used in the studies were adequate. The dosages were set by the scientists who designed and carried out the research in collaboration with the sponsoring companies.

U.S. conflict-of-interest law generally prohibits a federal employee from representing an outside party before a government agency. Walsh, in earlier comments to the newspaper, said that he appeared before the FDA not as a company representative but "as a government scientist providing information and/or evaluation" regarding clinical trials.

As for the dosages, Walsh and researchers with whom he collaborated had said that the studies were properly conducted and followed accepted standards of care. Both studies' designs were reviewed and approved by the FDA and by boards at the medical sites where patients were treated.

In their letter to the NIH director, the four congressional leaders requested a wide range of documents, including all internal financial-disclosure reports filed by Walsh from 1995 to 2005.

The letter also requested copies of any related policy that "permits [NIH] scientists as part of their official duties to assist drug companies with presentations to FDA advisory committees or FDA staff."



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