FDA Proposal for Ghostwritten Articles Criticized

The pharmaceutical industry seems to be heading for trouble after a report said Merck, one of the pharmaceutical bigwigs, had hired medical writers to ghostwrite articles in medical journals. While that itself may have been okay, what turned things around was the fact that the drug the writers wrote about was subsequently discredited by the FDA, a severe blow to credibility.

The drug in question is Vioxx, and Merck’s actions have caused parties opposing a federal order that brought down the stringency associated with promoting drugs down by a notch.

A report earlier said the FDA was looking at allowing drug manufacturers to reprint some of the articles published about different drugs. This step would allow drugs to be sold apparently for off-label uses. What makes this interesting is that the FDA itself has not given the approval for this exercise.

The report about Merck’s Vioxx blunder first surfaced Wednesday, when a major medical journal published it. The story first appeared in the journal of the American Medical Association (JAMA). Ever since it hit the industry, the story has brought to the fore several pertinent questions, regarding the authenticity of a number of such articles that have hit the Internet already.

Opposition to the Merck move is not just from one quarter. A number of groups and organizations, including the Blue Cross Shield Association – a trade association that has as its members 39 health insurance plan majors, the health commissioner for the State of New York, and also Public Citizen, have protested against the issue.

The pharmaceutical industry itself is for the proposal. Already, a group of 10 large pharmaceutical companies are taking the initiative from their side and getting on board the chief legal counsel for Merck to present the case from their perspective.

They are not the sole supporters of the FDA’s proposal. Other supporters include National Organization for Rare Disorders and also the National Alliance of Mental Illness.

The medical director of the National Alliance Illness, Dr. Kenneth Duckworth, said, while speaking in favor of the F.D.A proposal, that using drugs off-label ‘is one of the realities of treating people with illnesses that we don’t fully understand.’

Concerns regarding the usage of ghostwritten articles had surfaced even before the article that appeared in the JAMA Wednesday. On March 21, Dr. Allan M. Korn, the vice president of the Blue Cross association, had sent a letter to the F.D.A., mentioning that pharmaceutical companies could use ghostwritten articles to boost up the use of off-label drugs.