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For full versions of posted research articles readers are encouraged to email requests for "electronic reprints" (text file, PDF files, FAX copies) to the corresponding or lead author, who is highlighted in the posting.

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Thursday, October 11, 2007

Letter to the FDA urging action against a campaign promoting the unapproved use of Topamax for treating alcoholics (HRG Publication #1825)

October 9, 2007

Andrew von Eschenbach, MD, Commissioner
US Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. von Eschenbach:

I urge you to immediately stop the illegal and dangerous promotional campaign by Ortho-McNeil Janssen-funded researchers for the unapproved use of Topamax (topiramate) for treating alcoholics (the drug is only approved for treating seizure disorders and migraines).

In a study to be published in tomorrow’s Journal of the American Medical Association, funded entirely by the company, researchers from the company and from the University of Virginia find only a modest improvement in the percentage of days of heavy drinking in people using Topamax compared with people using a placebo. Both groups also got a weekly 15 minute intervention by a trained nurse to promote compliance.

But accompanying the study, in an embargoed press kit distributed by the University of Virginia on behalf of the researchers, is a question and answer sheet asking “Can my doctor prescribe me topiramate for alcohol dependence?” The answer is, essentially, yes: “Since topiramate is currently FDA-approved for seizures and migraines, it is available to your doctor to prescribe it to you off-label.” This clearly violates the prohibition on off-label promotion, as patients are being explicitly urged/promoted to ask their doctor for topiramate to treat their serious alcohol addiction.
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Read Full Letter
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