Congress to Probe Policies at NIH

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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.

Los Angeles Times - CA

By Willman, Times Staff Writer

August 10, 2006

http://www.latimes.com/news/nationworld/nation/la-na-

nih10aug10,0,2010043.story?coll=la-home-headlines

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 Ralbovsky said Wednesday.

The senior researcher, Dr. 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. D. Dingell, D-Mich., the ranking

Democrat; Rep. 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. "