Healthy Skepticism Library item: 18492

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

Silverman E
Glaxo Admits A Journal Supplement Wasn't Kosher
Pharmalot 2010 July 27
http://www.pharmalot.com/2010/07/glaxo-admits-a-journal-supplement-wasnt-kosher/

Full text:

File this under ’should have known better.’ Last year, GlaxoSmithKline wanted to promote its Avodart drug for shrinking enlarged prostates, so it paid for a supplement in the May 2009 edition of Urology. But the articles contained info about studies suggesting Avodart could reduce the risk of developing prostate cancer – and the FDA never approved Avodart for that use. One article claimed Avodart may be more effective than a rival Merck drug, despite a lack of head-to-head studies.
And so, two months later, Deirdre Connelly, who heads Glaxo’s North American pharma unit, wrote to apologize to the docs who received Urology. In her letter, Connelly acknowledged Glaxo failed to disclose it helped develop the supplement and select the docs listed as authors. The supplement disclosed funding came from Glaxo and some authors – most of whom were docs – had financial ties to the drugmaker, Connelly clarified in the letter Glaxo was the sole sponsor.
This development came to light thanks to The Wall Street Journal, which obtained documents indicating Glaxo conducted an internal investigation after someone at the drugmaker realized the supplement didn’t conform to FDA requirements due to mention of off-label uses. As required, Glaxo reported the episode to the HHS Office of Inspector General, which is conducting its own probe, and, meanwhile, also claims to have disciplined employees.
This is one of the more interesting recent instances involving the fuzzy world of journal supplements – although viewed as less credible, a recent study found they remain widely cited (see here). In any event, someone at Glaxo should be applauded for exposing the gaffe, although one may wonder why it occurred at all, given the heightened sensitivity to the controversy over pharma ties to docs and medical journal standards. After all, if Glaxo was doing a bang-up job of conveying ‘do’s and don’ts’ to its employees, then the episode should never have happened.
The episode also casts another spotlight on Elsevier, which publishes Urology. An Elsevier spokesman tells the paper that Urology followed its standard peer-review and disclosure steps, but claims not to have known the full extent of Glaxo’s involvement. He maintained full disclosure of support and commercial affiliations of authors is required. Last year, Elsevier was caught up in a scandal over a deal in which Merck paid for the creation of what appeared to be an independent journal that included lots of info about its drugs. Elsevier and a related company were also named as defendants in a lawsuit filed earlier this year alleging, in part, a conspiracy to improperly market the Risperdal antipsychotic (see the lawsuit).