FDA proposal on drug articles under fire

April 20, 2008

Claims that the pharmaceutical company Merck hired ghostwriters for Vioxx articles has put heat on a U.S. proposal to loosen drug promotion rules.

The painkiller Vioxx was a top-selling drug before it was taken off the market in 2004 after clinical trials found it increased heart attack risks.

The report on Vioxx, published Wednesday by the Journal of the American Medical Association, brought questions to light regarding the accuracy of peer-reviewed medical research studies, The New York Times reported.

"What does it mean to be peer-reviewed if the company has essentially conceived the article, composed the draft and written the paper?" said Dr. Joseph S. Ross, author of the the JAMA article.

The FDA reportedly has taken a proposal into consideration that would allow drug companies to use peer-reviewed articles for the promotion of off-label drugs the administration has yet to approve.

Public Citizen, New York's state health commissioner and the Blue Cross Blue Shield Association have all said they oppose the FDA plan, the Times reported.

Copyright 2008 by United Press International

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