The U.S. Food and Drug Administration said a GlaxoSmithKline PLC (GSK) television advertisement for its Avodart prostate-shrinking drug last year was misleading because it overstated the drug's effectiveness.
In a warning letter to the U.K. drug giant posted on the agency's Website Thursday, the FDA said a 60-second spot titled "Planetarium" presented " misleading comparative claims and overstates the efficacy of Avodart." The drug, which had $738 million in worldwide sales last year, is approved to shrink enlarged prostates in men, and to improve associated symptoms and conditions such as urinary retention.
The commercial featured models of planets - including a big one and small one - meant to illustrate the shrinking of an enlarged prostate. An actor says in the ad that Avodart is "different because over time it actually shrinks the prostate, so I go less often. Other medicines, they don't treat the cause, because they don't shrink the prostate."
The FDA said the ad suggests that Avodart is the only medication that shrinks the prostate, but this isn't the case. The agency says Merck & Co.'s (MRK) Proscar, which is also available from generic manufacturers, reduces prostate volume.
Also, the FDA said there was nothing in Avodart's prescribing label to suggest any specific advantages over other products. The agency isn't aware of any comparative clinical trials to support Glaxo's claim that Avodart is superior.
The FDA has asked Glaxo to immediately stop dissemination of these types of promotional materials.
GlaxoSmithKline spokeswoman Sarah Alspach said the ad ran from March to September of 2008, and won't be aired in the future.
"GlaxoSmithKline is committed to responsible marketing of our medicines," she said. "We are making every effort to ensure that future advertising for Avodart integrates the direction provided to us by the FDA."
Fid
Hat tip - The Truthman
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When GSK behave, please, e-mail me.
ReplyDeleteWhen GSK behave I'll probably be able to beam myself across the ocean to a destination of my choice Ana!
ReplyDeleteFid
""GlaxoSmithKline is committed to responsible marketing of our medicines," she said..."
ReplyDelete"You seem to have recurrent issues with dubious marketing techniques," began one presumptuous hack "should we assume that you're not as committed as that piece of paper you're holding in your hand suggests?"
The spokeswoman paused, and gestured to security guards with her eyes, who then accosted the hack and dragged him kicking from the pressroom.
"GlaxoSmithKline is committed to responsible marketing of our medicines." repeated the spokeswoman "Are there any other questions? No? That concludes GSK's presentation of the Absolute Unequivocal Truth, for today, then. Thank you for coming."
Matt
LOL Matt. Yeh that about sums GSK's statements up eh?
ReplyDeleteFid
Fidders: Yeah. I had in mind the intimidation of John Buse (and probably every other Pharma whistleblower), when I wrote my previous comment. The Worshipful Company isn't generally as openly abusive as my parody would suggest, but its behaviour is pretty clear, nonetheless.
ReplyDeleteMatt