Conflicts of Interest on Federal Advisory Committees: Should They Be Banned?
For readers in the Washington, DC area, you're invited to the National Press Club (529 14th St. NW, 13th fl.) on July 24th at 1 p.m. to hear a debate about how scientific advisory panels at the Food and Drug Administration, Environmental Protection Agency and National Academy of Sciences are formed, and whether they should continue to allow scientists with conflicts of interest to serve. Confirmed speakers include Steve Nissen of the Cleveland Clinic; Scott Gottlieb, deputy commissioner of the FDA; David Michaels of George Washington University; James Conrad of the American Chemistry Council; and Merrill Goozner of Center for Science in the Public Interest. Snigdha Prakash of National Public Radio will moderate.
Conflicted Scientists on NAS Board That Wrote Controversial Dioxin Report
At least four scientists with extensive ties to industry or direct financial conflicts of interest sat on the National Academy of Sciences advisory board that last week released a new dioxin assessment that environmentalists say may delay regulation for another year. Two of the 18 scientists on the panel reviewing whether the Environmental Protection Agency's 2003 draft reassessment of the risks of dioxin and dioxin-like compounds is "scientifically robust" received extensive funding from industry. Dennis M. Bier has consulted for most major food industry groups while Joshua Cohen has conducted three industry-funded studies in the last five years, including the fishing industry. At least one scientist on the panel had a direct financial conflict of interest. Michael Denison co-founded a company which holds a patent for dioxin detection.
JAMA, NEJM Editors Defend Toothless Conflict-of-Interest Policies
The editors of the Journal of the American Medical Association and the New England Journal of Medicine last week rejected demands that they penalize scientists who fail to disclose conflicts of interest in published articles. The Center for Science in the Public Interest renewed its call for editors to adopt a three-year ban for authors who fail to disclose conflicts of interest after the Wall Street Journal revealed that seven of 13 authors of a controversial study (subscription required) that supported pregnant women staying on anti-depressants had failed to disclose their ties to drug manufacturers. JAMA last week issued a correction and an editorial encouraging authors to be more forthcoming. Its editors learned about the failure from Tufts University-New England Medical Center professor Adam C. Urato in a letter to the editor (subscription required).
NCI Researcher Took Drug Firm Fees While Working on Collaborative Trials
A National Cancer Institute researcher received consulting fees from two drug companies between 1999 and 2004 while conducting clinical trials for those companies as part of his government job, the Los Angeles Times reported. In addition, records of those consulting fees were not turned over to a Congressional committee in 2004 while it was investigating conflicts of interest at the National Institutes of Health. According to Food and Drug Administration transcripts, Dr. Thomas J. Walsh, who works for the pediatric oncology unit at NCI, was identified as a company consultant when he appeared before a FDA advisory committee that approved Merck's new antifungal drug in 2001. Walsh told the Times that his appearance was not as a company consultant, but in his role as government scientist in charge of the government-industry collaborative clinical trial that led to the drug's approval. The article also raised questions about dosing choices in the study, which may have been designed to make the newer drug look better by underdosing the comparator drug. Several years earlier, Walsh had worked on that drug in collaboration with Fujisawa Inc.
Hospital Execs Paid by Healthcare Suppliers for Advice on Products
Chief executives from top non-profit hospitals acted as paid consultants to hand-picked drug and device vendors who were developing products for use in their hospitals, according to the New York Times. The Healthcare Research and Development Institute, a for-profit company that organizes ritzy conferences where hospital executives can meet with suppliers like Eli Lilly and Johnson & Johnson, is currently being investigated by Connecticut attorney general Richard Blumenthal, who believes hospitals may not be getting a fair deal when vendors "buy access" to those who are in a position to influence what supplies or services their institutions purchase. The arrangements were also attacked by the device manufacturers' trade group, which claims they favor the largest firms in the industry. "These conflicts prevent innovative, cost-effective products from entering the market," said Mark Leahey, executive director of the Medical Device Manufacturers Association.
Odds and Ends
The Nuclear Regulatory Commission has been forced to rely on 30-year-old data to assess the New Jersey Oyster Creek power plant's effect on marine life, the Atlantic City Press reports. Because nuclear facilities no longer collect such data, such environmental impact assessments have become largely irrelevant . . . A Food and Drug Administration committee meeting last week was going to evaluate behind closed doors a blood substitute previously deemed "unsafe." Public Citizen sued the agency for not complying with the Federal Advisory Committee Act, which makes public participation in such meetings mandatory.