The New York Times on Saturday examined how a recent report indicating that Merck used "ghostwriters" to produce medical journal articles in support of the COX-2 inhibitor Vioxx "has galvanized opponents to a federal proposal that would relax some restrictions on drug promotion" in the U.S.
According to the Times, new guidelines proposed by FDA would allow drug companies to use reprints of journal articles to promote drugs for so-called "off-label" uses that the agency has not approved. Under the guidelines, the articles must have been published in peer-reviewed medical journals. However, the Vioxx report, published in Wednesday's Journal of the American Medical Association, has "raised new questions about the validity of many published research studies, even in peer-reviewed publications," the Times reports.
The pharmaceutical industry supports FDA's proposed guidelines, according to the Times. A working group of 10 major pharmaceutical companies at a news briefing on Wednesday said that off-label uses of drugs and medical devices are necessary because researchers find possible new uses for the products before FDA can review them.
Opposition to the guidelines has "come from a diverse group that includes Public Citizen, New York state's health commissioner and the Blue Cross Blue Shield Association," the Times reports. BCBSA vice president Allan Korn sent a letter to FDA on March 21 warning that ghostwritten articles could be used to bolster off-label uses of drugs. New York Health Commissioner Richard Daines sent a letter to FDA on April 8 expressing concerns about possible industry manipulation of peer-reviewed journals. Daines said the disclosure about Merck "points out the potential weakness" in the FDA proposal.
Merck has denied that the physicians named as authors of the Vioxx studies did not play an integral role in writing the articles (Saul, New York Times, 4/19).
Editorial, Op-ed Address 'Ghostwriter' Issue