GlaxoSmithKline has apologized for failing to disclose its role in preparing content for a paid supplement to a medical journal last year. According to Dow Jones Newswires, the company has also admitted the supplement, which appeared in the May 2009 edition of the journal Urology, improperly discussed unapproved uses of its prostate-shrinking drug <"http://www.yourlawyer.com/practice_areas/defective_drugs">Avodart.
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.
The Glaxo-funded supplement that appeared in Urology 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.
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 Glaxoâ€™s North American pharmaceuticals sent a letter of apology to Urologyâ€™s subscribers, saying the company should have made clear that it helped develop the supplementâ€™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.
According to Dow Jones, 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.
Glaxo’s advertising and marketing of Avodart has caused problems for the drug maker in the past. In February 2009, the FDA sent Glaxo a warning letter regarding a space-themed ad for the drug. At one point in the spot, an actor makes the claim that that â€œother medicines, they donâ€™t treat the cause, because they donâ€™t shrink the prostate.â€
The FDA warning letter pointed out that Merck’s Proscar reduces the size of the prostate, and â€œhas a similar indication” as Avodart. â€œNothing in the labeling for Avodart suggests any specific advantage,” the FDA said.