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July 17, 2006

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Integrity in Science Watch

Week of 07/17/2006

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.

The NAS panel claimed that the carcinogenicity of low doses of dioxin, found in everyday products such as fatty food and drugs, may have been overstated in the EPA's reassessment. The panel advised the agency to rework its cancer risk evaluation before setting a standard. Experts estimate this will take a year. Stephen Lester, chief science director at the Center for Environmental Health and Justice, asserted industry influence on the panel led to the delay. Industry has already been able to "delay regulation on dioxin for 15 years," he said. Importantly, though, the panel did agree with EPA findings that dioxin exposure at low doses causes cancer and reproductive and immune-system disorders in humans.

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).

While many leading science and medical journals have good conflict-of-interest disclosure policies, compliance is voluntary and many scientists do not understand the concept. Dr. Adele C. Viguera, a professor at Harvard Medical School, is a member of GlaxoSmithKline's speakers bureau. Glaxo makes Paxil (paroxetine HCI), one of the world's best-selling anti-depressants and one of the drugs discussed in the JAMA article. Yet she told the Journal, "I don't believe there is a conflict of interest." Two years ago, CSPI documented a small but persistent problem of failures to disclose conflicts of interest in published articles at leading journals including JAMA and NEJM. JAMA had the worst failure rate among the four journals studied with 12 percent of authors flouting the rules.

In response to this week's revelations, JAMA editor Catherine DeAngelis said "we take this very, very seriously," but told the Wall Street Journal that she is "not an FBI agent" and "there has to be a certain level of trust" between the publication and authors who publish research. Jeffrey Drazen, editor of NEJM, told the Associated Press that editors were capable of self-policing their journals without using penalties even though his Journal has suffered similar problems. "Editors have very long institutional memories," Drazen said. "I think that's adequate in this case." CSPI called for a three-year ban because fear of exposure by colleagues when there is a penalty for non-disclosure is one way to police their voluntary policies. It also called on the International Committee of Medical Journal Editors, which includes all of the leading medical journals, to adopt a reciprocity policy where a temporary ban on publishing in one journal would extend to all members of the consortium.

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.