Healthy Skepticism Library item: 18612

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
Avandiagate: Glaxo And A Controversial Memo
Pharmalot 2010 Aug 23
http://www.pharmalot.com/2010/08/avandiagate-glaxo-and-a-controversial-memo/

Full text:

Avandiagate, as some have called it, appears to be never ending. In the latest twist, a letter and accompanying memo that GlaxoSmithKline wrote and distributed at the behest of the FDA is now itself the subject of a flap because some experts say the contents are misleading. And this occurs just as the agency gets set to decide the fate of the controversial Avandia diabetes pill, The New York Times writes.
The letter was supposed to bring doctors up to date on two things – the outcome of a recent FDA advisory committee meeting about Avandia, which the panel decided should remain on the market but with restrictions, and a decision by the FDA to halt Glaxo’s TIDE clinical trial designed to assess cardiovascular risk when compared with the rival Actos drug (background here and here). The July 28 letter and a 10-page summary of the FDA panel meeting (read them here) was sent to TIDE investigators.
The Glaxo missives, however, fail to accurately summarize various key elements, such as an Avandia clinical trial known as RECORD, which the drugmaker cited as evidence its diabetes drug was safe, but was skewered by FDA medical reviewer Tom Marciniak (see this). “GSK presents the original RECORD data as if it were accurate, with no mention of Marciniak’s re-analysis, there is no discussion of the evidence that pioglitazone (Actos) has a lower risk than rosiglitazone (Avandia), and the document states that FDA found no problems with the conduct of RECORD,” Steve Nissen of the Cleveland Clinic Foundation, who conducted a meta-analysis finding heart risks with Avandia and who battled with Glaxo over the release of its trial data, writes us.
“This summary is biased, misleading and not truthful,” FDA medical reviewer David Graham, who co-authored a recent study in JAMA about Avandia heart risks, tells the Times. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the TIDE trial are not even referenced.”
Similarly, several members of the FDA advisory committee tells the newspaper that Glaxo’s account is biased. “This letter is really deceptive,” says Clifford Rosen, adding that the letter did not refer to a presentation at the hearing by members of an Institute of Medicine study panel that said observational studies could be useful. And Curt Furberg described the letter as a “very Avandia friendly” document that ignored much of the discussion criticizing the validity of Glaxo’s studies. But panel member Sanjay Kaul tells the Times the letter “faithfully reflects the deliberations of the Avandia advisory meeting.”
A Glaxo spokeswoman tells the paper that the drugmaker had only one week to write its summary, which was had to be brief, but that Glaxo officials and the leader of the TIDE trial agreed the letter “reflected the science and data discussed at the advisory committee meeting.”