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Glaxo Cops to Mistakes in Paid Supplement

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GlaxoSmithKline has apologized for the way it handled a paid supplement that appeared in the journal Urology last May. According to Dow Jones Newswire, Glaxo also disciplined the employees involved in creating the supplement, and made a report to the U.S. Department of Health and Human Services’ inspector general’s office. Under previous settlements with the federal government involving its marketing practices, Glaxo is required to report any possible violations of certain federal laws to HHS, Dow Jones said.

The Glaxo-funded supplement contained articles on prostate cancer written by several doctors. Glaxo helped develop the supplement’s content and select the doctors who were listed as authors of the articles, Dow Jones said. Some of those included information regarding clinical testing of Avodart as a treatment for men at high risk for the disease. One article also went so far as to state that Avodart “might prove to be more effective than” a competing drug, Merck & Co. Proscar, in prostate-cancer risk reduction.

Avodart is currently approved as a treatment for enlarged prostate, but the Food & Drug Administration (FDA) is still considering Glaxo’s application to market it for reduction of prostate-cancer risk, Dow Jones said. While doctors are permitted to prescribe approved drugs in anyway they see fit, drug makers are forbidden from promoting unapproved, or “off label”, uses of their medications.

Shortly after it was published, Glaxo’s compliance department investigated the supplement, Dow Jones said, and concluded the company should have been more up-front about its role. In July 2009, the president of Glaxo’s North American pharmaceuticals sent a letter of apology to Urology’s subscribers, saying the company should have made clear that it helped develop the supplement’s content and select the authors, and clarified its role as the supplement’s sole financial sponsor. The letter also said the article comparing Avodart to Proscar shouldn’t have made such comparisons because the two drugs never went head-to-head in clinical trials.

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