Glaxo Gets Aggressive On Avandia
On day five of Avandiagate, GlaxoSmithKline communiques about the brouhaha surrounding the controversial diabetes drug now number six.
One rejecting the conclusions drawn in the "New York Times," which broke the story, another rejectingthe findings of the Senate Finance Committee investigation that the Times story was about, two blogposts, including a rare one penned by the company's top U.S. corporate communications exec, and today a press releaseand 30-page "White Paper" formal response to the Senate probe.
Someone's been burning the midnight oil.
The Senate investigation claims GSK knew about the heart safety risks of Avandia long before The Cleveland Clinic's Dr. Steven Nissen published a study about them and tried to conceal and/or downplay the evidence. Dr. Nissen's study, which is the subject of much debate, caused Avandia sales to plummet. But GSK is trying to protect what's left of the franchise and to defend itself from litigation.
According to plaintiffs' lawyer Mark Lanier, who made a name for himself in big pharma suing Merck over Vioxx, there are approximately 15,000 Avandia lawsuits.
He's scheduled to try the first one in June in Philadelphia, where, until recently, the British Glaxo had its U.S. headquarters. But that number pales in comparison to the nealy 50,000 Vioxx cases. And, what's more, Lanier says the statute of limitations has already run out on Avandia in most states. The FDA ordered that a boxed warning be put on the Avandia label about the possible heart risks a couple of years ago, so Lanier says it'd be really tough for any new plaintiffs to claim they didn't know the drug might hurt their heart.
Lanier calls the Senate findings "old news" because he's been working with the same, previously undisclosed info for a couple of years already. I was incredulous when Lanier of all people told me that over the weekend. I expected him to be drooling, ready to pounce on Glaxo and jump on TV. But as Joe Kernen suggested on "Squawk Box" the other day, Lanier may see more dollar signs in Toyota cases right now. His is a big firm, though, so I'm certain it can handle lots of different stuff.
And the rhetoric is escalating. Here are just a few colorful snippets from the deep dive GSK takes in its "White Paper":
"...the (Senate) Staff Report mischaracterizes and distorts the efforts that GlaxoSmithKline took to continue to monitor the safety and efficacy of its diabetes medication. The Staff Report repeatedly cites documents out of context; thereby, crafting a misleading narrative...."
"These numbers (about heart risk cited by an FDA whistleblower) simply do not reflect reality."
"There is no scientific basis on which to assume that Avandia causes excess (heart attacks) or cardiovascular death."
"...methodology is seriously flawed and based on incomplete data."
And regarding the allegation Dr. Nissen made in my interview with him earlier this week that GSK "stole" an advance, embargoed and confidential copy of his "New England Journal of Medicine" report Glaxo will only say, "GSK received an unsolicited copy of Dr. Nissen's manuscript.
GSK did not provide comments or any input on the manuscript and acted appropriately and responsibly in responding to the situation."
All of GSK's statements, thus far, have been in writing.
As far as I'm aware, the company hasn't made any execs available to any media outlets for interviews yet in the wake of the story breaking. Oh, you know we've asked. I'm almost certain the company takes some comfort in the timing—that Toyotagate is totally overshadowing Avandiagate this week. With President Obama holding his health care summittomorrow, I suspect some politician is gonna bring it up, though, and Glaxo could have gotten out in front of it.
But I'm just a beat reporter after a good get.
Questions? Comments? Pharma@cnbc.com and follow me on Twitter at mhuckman