T1B

Senate report: Avandia maker knew of cardiac risks

By BARBARA ORTUTAY
The Associated Press
Saturday, February 20, 2010; 5:21 PM

NEW YORK -- A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.

Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee's ranking Republican, released the report, which follows a two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

The agency ordered a warning to be included on Avandia's label in 2007, saying that it might increase the risk of heart attacks, though the data on those risk was inconclusive.

Soon afterwards Sen. Grassley, one of the FDA's toughest critics in Congress, disclosed that the agency's internal safety experts came within one vote of recommending a withdrawal of Avandia.

The Senate report suggests sharp disagreements remain at the FDA over how to handle Avandia's risks.

In a letter to FDA Commissioner Margaret Hamburg that was also released Saturday, the senators said the committee's report was based on researchers' studies of Avandia, internal GlaxoSmithKline documents and FDA documents. They said committee investigators had interviewed GlaxoSmithKline and agency employees as well as what it called anonymous whistleblowers.

Based on its knowledge of the heart attack risks, GlaxoSmithKline "had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner," the report said.

Instead, the company tried to downplay findings that the drug could increase cardiovascular risks while also working to downplay findings that a rival medication might reduce such risks, it said.

GlaxoSmithKline said in a statement the drug is safe. It said the committee report took data out of context from analyses of Avandia.

In May 2007, the New England Journal of Medicine published an analysis of dozens of studies on nearly 28,000 people who had taken Avandia. The journal said there was a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication. The findings raised concerns because two-thirds of the people with Type 2 diabetes, the most common form, die of heart problems.

JMak wrote:Facefuck a log-hauler, jerkstick.

Screw_Michigan wrote:

JMak wrote:Facefuck a log-hauler, jerkstick.

That's a new take. Rack that.

Screw_Michigan wrote:What about warm, Tom?

Dinsdale wrote:And the same "more regulation" tards will inevitably cry out for "tort reform" -- if the court system worked properly, Glaxo would now be owned by those they wronged...

BSmack wrote:[
That really would help out the people who died.

LTS TRN 2 wrote:If that was a chick, she needs as much help as you-- I mean she sputters...just like a weasel, and she carps...just like a weasel, and she squats to pee...just like a weasel...but--you're telling me--she plays with an actual twat...

Dinsdale wrote:

BSmack wrote:[
That really would help out the people who died.

You're a fucking idiot.

I'd go into more detail as to the "why" you're an idiot... but would we really be covering any new ground?

mvscal wrote:Who, exactly, is making the claim that the free market can regulate itself? Names?

LTS TRN 2 wrote:

mvscal wrote:Who, exactly, is making the claim that the free market can regulate itself? Names?

Milton Friedman (disgraced, dead, silent)

The role of government just considered is to do something that the market cannot do for itself, namely, to determine, arbitrate and enforce the rules of the game. We may also want to do through government some things that might conceivably be done through the market but that technical or similar conditions render it difficult to do in that way. These all reduce to cases in which strictly voluntary exchange is either exceedingly costly or practically impossible. There are two general classes of such cases: monopoly and similar market imperfections, and neighborhood effects.

A second general class of cases in which strictly voluntary exchange is impossible arises when the actions of individuals have effects on other individuals for which it is not feasible to charge or recompense them. This is the problem of "neighborhood effects". An obvious example is the pollution of a stream. The man who pollutes a stream is in effect forcing others to exchange good water for bad. These others might be willing to make the exchange at a price. But it is not feasible for them, acting individually, to avoid the exchange or to enforce appropriate compensation.

LTS TRN 2 wrote:No, it's a conclusive example of weaseling on Friedman's part--as he'd been forced to do since the 1970's--backtracking and revising his libertarian/Republican edicts just a bit--always a caveat or disclaimer.