Glaxo Admits Mistakes With Paid Medical Journal Supplement

26th Jul 2010 14:15

By Peter Loftus Of DOW JONES NEWSWIRES Drug maker GlaxoSmithKline PLC (GSK, GSK.LN) has admitted it wasn't fully transparent about its role in preparing a paid supplement to a medical journal last year, and that the supplement improperly discussed unapproved uses of its prostate-shrinking drug Avodart. The revelation comes as drug makers face government scrutiny of their roles in crafting favorable articles about their products in medical journals, which can influence doctors' prescribing patterns. More broadly, accusations of aggressive marketing and improper research practices have been at the center of legal settlements for which the industry has collectively shelled out billions of dollars in recent years. Glaxo funded a supplement, to the May 2009 edition of the journal Urology, that contained articles about prostate cancer, including information about clinical testing of Avodart's ability to reduce the risk of developing the cancer. Glaxo hasn't secured U.S. regulatory approval to market Avodart for this use, and drug makers are barred from actively promoting so-called off-label uses of drugs. Avodart is approved to treat benign enlarged prostates in men. Soon after the supplement was published, in July 2009, Deirdre Connelly, president of Glaxo's North American pharmaceuticals unit, wrote a letter of apology to the doctors who received it. In her letter, Connelly said the U.K.-based drug maker had failed to disclose it helped develop the supplement's content and select the doctors who were listed as authors of the articles. Although the supplement did carry a disclosure that Glaxo funded it and some of the authors--most of whom were doctors--had financial ties to Glaxo, Connelly clarified in the letter Glaxo was the sole sponsor. "We apologize for the lack of sufficient transparency and for the errors," Connelly wrote. Dow Jones Newswires recently obtained a copy of the letter through a Freedom of Information Act request to the U.S. Department of Health and Human Services. Glaxo conducted an internal investigation and took corrective actions, including disciplining employees and reporting the matter to HHS's inspector general's office, said Michael Shaw, vice president of ethics and compliance for Glaxo's North American pharmaceuticals unit. Glaxo is required to self-report to HHS's inspector general any potential violations of certain federal laws, in accordance with previous settlements of government probes of Glaxo's marketing practices. The HHS inspector general's office is reviewing the matter, said spokesman Don White. Glaxo ultimately concluded the paid Urology supplement shouldn't have mentioned off-label uses of Avodart because Food and Drug Administration promotional regulations would apply to the supplement. One article stated that due to differences in mechanisms, Avodart "might prove to be more effective than" a competing drug, Merck & Co.'s (MRK) Proscar, in prostate-cancer risk reduction. In her letter, Connelly said the supplement shouldn't have made such comparisons because the drugs weren't pitted against each other in a head-to-head clinical trial. A Glaxo-funded study found Avodart reduced the risk of prostate cancer by 23% compared with a fake drug. Glaxo has applied for FDA approval to market the drug for this use but the agency hasn't made a final decision. First-half 2010 Avodart sales were GBP296 million (about $450 million). Urology, a monthly journal with peer-reviewed information intended for urologists and other specialists, is published by Reed Elsevier NV's (ENL) Elsevier unit and has about 4,640 subscribers. Elsevier spokesman Tom Reller said the journal followed its standard peer-review and disclosure processes in running the Glaxo supplement, but it hadn't known the full extent of Glaxo's involvement in preparing the supplement. He said full disclosure of support and commercial affiliations of authors is required by the journal. U.S. Sen. Charles Grassley (R., Iowa) and other industry critics have pushed for increased transparency surrounding drug companies' financial ties to doctors, medical schools and journals. One of their objectives, a public database of industry payments to doctors, was included in this year's U.S. health-care overhaul legislation and takes effect in 2013. Glaxo and some other companies already have begun posting physician-payment data online. Last year, it was revealed that Merck had paid Elsevier several years ago to publish what appeared to be a nonbiased medical journal, but what in reality was a publication sponsored by Merck and containing information about Merck drugs, including the former pain reliever Vioxx. This isn't the first time Glaxo's Avodart marketing has been called into question. Last year the FDA sent Glaxo a letter warning that a television ad for the drug was misleading because it overstated the drug's effectiveness. Last week, Glaxo disclosed it would record a second-quarter charge of $2.4 billion to cover costs associated with the resolution of various legal matters, including Glaxo's efforts to settle a federal probe of its sales and promotional practices, as well as the settlement of product-liability litigation for the diabetes drug Avandia, which has been linked to heart problems. -By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; [email protected] (END) Dow Jones Newswires July 26, 2010 09:15 ET (13:15 GMT)