FDA Set to Approve Ghost-Writing

April 16, 2008
http://www.gooznews.com/archives/001022.html

All the major newspapers that circulate in the nation's capital (the New York Times, the Wall Street Journal, and the Washington Post) carried stories this morning about a new study in the Journal of the American Medical Association that showed about half of articles that appeared in the medical literature touting Vioxx had been ghost-written by employees or contractors working for Merck, the drug's manufacturer.

What none of those stories or the study mentioned was the regulatory context in which this study (and an accompanying one alleging Merck manipulated the data in one of those studies to hide the mortality risk among Alzheimer's patients who used the drug) appears. The Food and Drug Administration wants to give drug manufacturers like Merck a blank check to distribute to physicians nearly any article advocating off-label use of drugs that appears in the medical literature.

The only substantive criteria in the proposed guidance is that the article be peer-reviewed and reflect "well-controlled" clinical studies. It would abandon the FDA's prior practice of pre-reviewing articles advocating the off-label use of drugs before they could be distributed by industry salesmen. Under this proposal, virtually all of Merck's ghost-written studies could have been distributed. As it was, the company bought nearly a million copies of the seminal study that led to the approval of Vioxx that had appeared in the New England Journal of Medicine.

The draft guidance has already drawn fire from Rep. Henry Waxman (D-CA), and I commented on it in this post, "FDA Proposes Lack-of-Evidence-Based Medicine Policy" when it first came out. Perhaps the best thing that readers of this blog can do at this point is to write to the FDA protesting these proposed guidelines, which you can do by going to the Regulations.gov website, putting in the docket number -- FDA-2008-D-0053 -- and hitting the "submit a comment" button.

Despite a New England Journal of Medicine commentary opposing the guidance last week, there were only 33 comments as of this morning, many of them from industry groups that support liberalizing the reprint policy. A patient and consumer coalition in which I take part plans to file comments before the deadline, which is next Monday. I hope to post those comments in this space later in the week.

You can read the study on ghost-writing here; and the re-analysis of the Merck Alzheimer trial here.

This issues raised by Drs. Bruce Psaty and Richard Kronmal in the Alzheimer's trial are especially disturbing since the company, which ran the trial, did not set up a data safety monitoring committee. Company officials and lawyers quoted in the stories said it wouldn't have made a difference. But Psaty, one of the nation's leading independent biostatisticians, said, "This was a huge safety signal. If this had been made public in a timely fashion, many fewer patients would have used Vioxx, and fewer might have been harmed by it."

The authors conclusions, which go far beyond the ghost-writing issue, are worth pondering:

For sponsors that conduct their own studies or use contract research organizations to conduct studies, it is not clear how transparency in the reporting of results can be achieved if a sponsor chooses to represent its products in the best possible light. The commercialization of clinical trials has neither improved the quality of the science nor enhanced the protection of human research participants.

The findings from this case study suggest that additional protections for human research participants, including new approaches for the conduct, oversight, and reporting of industry-sponsored trials, are necessary. A clinical trials system in which sponsors fund the trials that are conducted by independent investigators would provide additional protections.


Posted by gooznews at April 16, 2008 08:32 AM
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