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NIH halts neonatal herpes session after protest.

The National Institute of Allergy and Infectious Diseases (NIAID) abruptly cancelled a conference on neonatal herpes aimed at writing clinical practice guidelines shortly after a coalition of influential physicians and consumer groups protested conflicts of interest and the lack of balance among the meeting's presenters. Sixteen health groups and 44 physicians signed onto a letter sent to the National Institutes of Health (NIH) which 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. The NIH has not yet responded to this request, but has indicated that it will review its policies in this area.

The letter--whose signers included the NWHN; Lancet editor Richard Horton; and two former New England Journal of Medicine editors, Marcia Angell and Jerome P. Kassirer--noted that many recent NIH-sponsored guideline-writing panels have been dominated by physicians with conflicts of interest. For example, on the National Heart, Lung, and Blood Institute's guideline-writing committees on hypertension and cholesterol management, 9 of 11 and 8 of 9 members, respectively, had such conflicts of interest. With insurers moving toward adopting pay-for-performance standards that 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?" Consumer groups that signed 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.

NWHN joined in the effort to stop the NIH's plans to create guidelines to screen all pregnant women because of our concerns about the harm that routine screening would cause. While nearly 25 percent of all pregnant women have asymptomatic herpes, the risk of passing the disease to their babies is extremely slim. Moreover, there's no proof that anti-herpes medication reduces the risk of mother-to-fetus transmission of the disease. There is good evidence, however, of the harm that herpes medicine can cause, including a rare blood disorder in babies and both seizures and kidney failure in adults. (Herpes medication is recommended for women who become infected, or who have an outbreak from an earlier infection, during pregnancy.)

The NIAID letter canceling the meeting told registrants that there had been "a misunderstanding about the intent of the meeting." The agenda sent to invitees throughout December, however, included a final session led by Richard Whitley of the University of Alabama at Birmingham, who consults for anti-herpes drug manufacturer 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. More information can be found at the Integrity in Science site; for a copy of the letter to the NIH, see: htt:// herpes letter.pdf.
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Title Annotation:National Institutes of Health
Publication:Women's Health Activist
Geographic Code:1USA
Date:Mar 1, 2007
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