Center for Science in the Public Interest

For Immediate Release: January 22, 2007

Integrity in Science Watch

Week of 01/22/2007

NIH Halts Neonatal Herpes Session after Protest

The National Institute of Allergy and Infectious Diseases abruptly cancelled a conference on neonatal herpes aimed at writing clinical practice guidelines shortly after a coalition of influential physicians and consumer groups protested the lack of balance and conflicts of interest among the meeting's presenters (see Integrity in Science Watch, 1/8/07). A letter sent to NIH, signed by 44 physicians and 16 health groups, called on director Elias A. Zerhouni to adopt an agency-wide rule prohibiting scientists with financial conflicts of interest from sitting on guideline-writing panels. NIH has not yet responded to the request.

The letter, whose signers included Lancet editor Richard Horton and two former New England Journal of Medicine editors, Marcia Angell and Jerome P. Kassirer, pointed out that many recent NIH-sponsored guideline-writing panels have been dominated by physicians with conflicts of interest. The National Heart, Lung, and Blood Institute's guideline-writing committees on hypertension and cholesterol management, for instance, had 9 of 11 and 8 of 9 members, respectively, with conflicts of interest. With insurers moving toward adopting pay-for-performance standards that would reward physicians who follow widely accepted clinical practice guidelines, the letter asked: "Why should either practicing physicians or patients have faith in guidelines written by researcher-physicians with ties to providers whose financial well-being is driven by the content of those recommendations?" Consumers groups signing the letter included the Center for Medical Consumers, the National Research Center for Women & Families and the Center for Science in the Public Interest, which led the effort.

The NIAID letter cancelling the meeting told registrants that there had been "a misunderstanding about the intent of the meeting." However, the agenda sent to invitees throughout December included a final session led by Richard Whitley of the University of Alabama at Birmingham, who consults for anti-herpes drugmaker GlaxoSmithKline. The printed agenda's bullet points for that final session were "Codification of guidelines," "Writing Teams" and "Deadlines."

In mid-December, the Wall Street Journal ran a front page story describing how GlaxoSmithKline, which makes the anti-herpes medication Valtrex (valacyclovir), has funded researchers and continuing medication seminars to promote universal herpes testing among pregnant women, which could lead to significantly higher drug sales.

EPA to Announce NOx and SOx Panel Members This Week

The Environmental Protection Agency is expected to announce this week the membership of a scientific review panel that will advise the agency on air quality standards for nitrogen and sulfur oxides, agency spokesman Fred Butterfield said Friday. Clean Air Watch and the Center for Science in the Public Interest submitted comments to the agency last week on its "short list" for the Clean Air Scientific Advisory Committee NOx and SOx Primary Review Panel objecting to the nomination of longtime industry consultant Roger McClellan, a former president of the Chemical Industry Institute of Toxicology. CSPI also objected to the inclusion of two other scientists with industry ties, Richard Schlesinger and Christian Seigneur.

COI Waivers Abound at FDA Despite Curbs

An analysis of a series of Food and Drug Administration advisory panels meeting this week reveals that the agency is taking few steps to curb its use of scientists with conflicts of interest, even though an amendment to last year's FDA appropriations bill requires the agency to document what steps it took to limit the use of advisers with financial ties to drug and device makers. A reproductive drugs panel discussing new standards for hormone-derived birth-control pills, patches and rings like those made by Berlex Inc. includes three members with financial ties to Berlex. The FDA's vaccine advisory committee, which will discuss the safety of vaccine combinations manufactured by Sanofi-Aventis, issued four conflict-of-interest waivers. And the Neurological Devices Advisory Committee, which is evaluating a new device for major depression that uses short bursts of magnetic energy aimed at the brain, includes five members that have been granted waivers.

Cancer Docs Adopt Strict Disclosure Policy

The American Society of Clinical Oncology is forcing cancer doctors to disclose all financial ties to investment firms as part of an affort to stop leaks of confidential information to Wall Street insiders, Bloomberg reported Saturday. The new policy, which takes effect immediately, requires cancer doctors to disclose all consulting or advisory relationships they have with private firms. Allen Lichter, the society's chief executive officer, said the policy applies to group members who publish in the Journal of Clinical Oncology and give public speeches at its meetings. A brief outline of the policy was included in the Dec. 20, 2006, edition of the journal.

Experts Develop Model Language to Help Researchers Disclose Financial Interests

Experts from three universities have published new language designed to give clinical researchers guidance on how to disclose possible financial conflicts of interest. The new language, published in the January issue of IRB: Ethics and Human Research, was developed as part of a $3 million, five-year project called the Conflict of Interest Notification Study, which is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. The new disclosure statements are meant to be given to potential research participants before they consent to participating in a trial, Johns Hopkins University officials said in a press release announcing the report.

UC Regents Weigh Whether Schools Should Shun Tobacco Money

University of California regents voted last week to postpone until May a decision on whether scientists should be banned from taking money from the tobacco industry to give faculty members time to comment on the proposal, the Sacramento Bee reported. Supporters of the proposal note that taking money from tobacco companies could damage the university system's reputation because of the industry's reputation for distorting research. The UC system had 19 active grants worth $16 million funded by the tobacco industry in late 2006, all from Philip Morris, the president's office said.

Odds and Ends

The Environmental Protection Agency said last week it will not shut down more libraries or destroy more documents until a congressional review takes place. ... Lettuce producer Fresh Express announced last week that it would pay up to $2 million to fund research aimed at preventing future E. coli outbreaks. The company said the money would pay for research projects selected by an independent panel of scientific experts, without restrictions from Fresh Express as to research funding or the dissemination of results. ... The Associated Press reported last week that the University of Virginia Medical Center has joined a growing number of U.S. medical schools and hospitals that are banning gifts from pharmaceutical company sales representatives. ... The Environmental Protection Agency said last week at a meeting of the 16-member panel that will review the agency's risk assessment for ethylene oxide that no conflict-of-interest waivers had been issued for the panel, despite the fact that it includes ExxonMobil scientist Robert Schnatter and two industry consultants. In a phone interview today, Sue Shallal, the designated federal official for the panel, stressed that the agency was primarily concerned with ensuring that panel members did not have direct ties to companies that manufactured, used or disposed of ethylene oxide -- a category that does not include ExxonMobil.


Last week's Integrity in Science Watch inaccurately reported that Bryan Hardin and Bruce Kelman are principals at a law firm paid $375 to $500 an hour as defense counsel in mold lawsuits. In fact, Hardin and Kelman are paid $375 to $500 an hour in their role as principals of the environmental risk management company Veritox Inc., a firm that regularly works for the defense in mold cases. Integrity in Science Watch regrets the error.

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