Paxil for Children: Safety, Efficacy Aren’t Established – Letter WSJ

Paxil for Children: Safety, Efficacy Aren’t Established – Letter WSJ

Fri, 9 Jul 2004

Dr. Arnold Relman, Professor Emeritus, Medicine and Social Medicine, Harvard Medical School, and former editor of The New England Journal of Medicine, responds to a June 21 editorial in The Wall Street Journal. The editorial attacked New York State Attorney General, Eliot Spitzer, for filing a lawsuit against GlaxoSmithKline for promoting Paxil for children while concealing safety and effectiveness data. The editorial made the preposterous claim that pharmaceutical companies failure to disclose vital safety information was protected under the first amendment.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

THE WALL STREET JOURNAL
Letters to the Editor
Jul 9, 2004
A.11

Your June 21 editorial on Paxil and the legal action against GlaxoSmithKline omits or misrepresents key facts. The safety and effectiveness of Paxil in the treatment of depression in children has not yet been established. The FDA has not yet approved it, and there is no application pending. Nevertheless, as New York State Attorney General Eliot Spitzer’s suit charges, GSK has been promoting the “off- label” use of Paxil in children by having its detail people tell physicians about the clinical trial it sponsored and published, which provided equivocal favorable evidence.

The company has not told doctors about the results of two other trials it conducted, which failed to demonstrate any benefit and have not been published. The FDA has the results of those two negative trials but has no legal requirement to make them public and has not done so.

Should a pharmaceutical company have “the right to stay silent” when it has medical information that would probably affect the prescribing decisions of physicians? Most people would agree with Mr. Spitzer, and say no. In fact, there is a growing opinion that drug companies should be required to report the results of all clinical trials, positive or negative. Even GSK itself has recently announced that it will henceforth make the results of all of its clinical trials public, thus tacitly agreeing with the thrust of the New York action.

Arnold S. Relman, M.D.
Professor Emeritus
Medicine and Social Medicine
Harvard Medical School
Cambridge, Mass.

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