Healthy Skepticism Library item: 18498

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Loftus P
GSK Apologizes Over Medical Journal Snafu
The Wall Street Journal Blog 2010 July 26
http://blogs.wsj.com/health/2010/07/26/gsk-apologizes-over-medical-journal-snafu/

Full text:

It must have seemed like a good idea at the time to the folks at GlaxoSmithKline: Pay a medical journal to run a special supplement about prostate cancer, which – surprise – included information about a Glaxo drug.

That’s what the UK drug maker did for the May 2009 edition of Urology, a peer-reviewed journal published by Elsevier. The supplement had articles by several doctors and included information about clinical testing of Glaxo’s drug Avodart in men at risk for prostate cancer. Avodart is approved to shrink benign, enlarged prostates but the FDA hasn’t made a final decision on the company’s application to market it for reduction of prostate-cancer risk.

It wasn’t long before Glaxo – already under a government microscope for its past marketing practices – had second thoughts about the supplement. The company’s compliance department investigated, concluded the company should have been more up-front about its role, and took action.

In July 2009, the president of Glaxo’s North American pharmaceuticals unit, Deirdre Connelly, 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. She also clarified that Glaxo was the sole financial sponsor. (To be sure, the supplement’s title page did include a disclosure that it was made possible by funding from GSK, and a second page disclosed that several of the physician-authors had financial ties to the company.)

Here’s the Dow Jones Newswires story on the whole affair. DJN obtained documents related to Glaxo’s funding of the Urology supplement through a Freedom of Information Act request.

In her letter, Connelly wrote that GSK shouldn’t have discussed uses of Avodart not approved by FDA, nor should it have suggested Avodart was superior to Merck’s Proscar because the two weren’t studied in a head-to-head clinical trial.

Glaxo also took unspecified disciplinary action against employees as a result of the supplement, Michael Shaw, VP of ethics and compliance for North American pharmaceuticals, tells DJN, and self-reported the matter to the HHS’s Office of Inspector General. (Like several of its competitors, including Pfizer, Merck and Eli Lilly, Glaxo is required to report potential violations of federal law to the IG under the terms of prior settlements regarding its marketing practices.)

Elsevier said it didn’t know the full extent of Glaxo’s role in preparing the supplement, and that it requires full disclosure for its supplements.

If the idea of sponsored medical-journal content sounds familiar, recall that last year Merck and Elsevier took some heat for an early 2000s arrangement in which Merck paid Elsevier to publish what appeared to be an unbiased journal, but was in fact sponsored by Merck and included information about the company’s products, including the now-pulled pain drug Vioxx. Elsevier launched an internal review into the matter. ( Here’s Merck’s statement on all of that.)

Meanwhile, drug-company ties with medical journals have been the subject of an investigation by Sen. Charles Grassley, who has pushed for greater disclosure of industry ties to journals, doctors and medical schools. An effort he pushed – a public database of industry payments to doctors – was included in this year’s health-care overhaul legislation.

Glaxo has already begun voluntarily posting physician-payment data on its website, in advance of the new law’s requirements.