F.D.A. Plan on Medical Articles Takes More Heat

[Celebration]

http://www.nytimes.com/2008/04/19/business/19ghost.html?_r=1&oref=slogin

The pharmaceutical industry glimpsed its own ghost this week, and the apparition could not have arrived at a worse time for drug makers.

A report indicating that Merck used ghostwriters to produce medical journal articles in support of its subsequently discredited drug Vioxx has galvanized opponents to a federal proposal that would relax some restrictions on drug promotion.

The Food and Drug Administration has been considering a proposal to let drug makers use reprints of journal articles in promoting drugs for so-called off-label uses the F.D.A. itself has not approved. A main proviso of the proposal is that the articles must have been published in peer-reviewed medical journals.

The Vioxx report, published Wednesday by a leading medical journal, JAMA, has, however, raised new questions about the validity of many published research studies, even in peer-reviewed publications.

Opposition to the F.D.A. proposal has come from a diverse group that includes Public Citizen, New York State’s health commissioner and the Blue Cross Blue Shield Association, a trade association of 39 major health insurance plans.