The FDA should be making the call any day now. After years of controversy and relabeling surrounding the type 2 diabetes mellitus drug Avandia (generic: rosiglitazone), internal documents and recommendations obtained and released by the New York Times shows that the agency is on the ledge.

The drug was approved in 1999, and problems were reported by the World Health Organization in 2003/2004. GSK knew about problems as early as 2003, and the FDA was warned by the American Diabetes Association a few months after the drug was approved. And here we are, a decade after approval, and people are still dying.

"Avandia...was linked to 304 deaths during the third quarter of 2009"

Intended to save lives, the drug is actually killing people. NBC news just broadcasted that the drug has been associated with 83,000 excess deaths, meaning that had Avandia not been on the market over the last few years, 83,000 fewer heart attacks would likely have occurred.

GlaxoSmithKline is defending their drug, saying that there are contradictory studies, but a U.S. Senate investigation has determined that the company has not been appropriately warning patients (consumers, customers) of the heart risk of their product. 

There is an alternative to the drug, one that has been shown to not have the heart attack risk. It's called Actos.

In the presence of alternatives for controlling blood sugar and insulin, which are the issues in diabetes, the drug should be pulled. With the recent leaking of the FDA's internal fight over keeping the drug on the market (one of the former best-sellers in the pharmaceutical industry, by the way), it shouldn't be long before it's pulled simply so the agency can save face, particularly with such low public confidence already.

The American Diabetes Association has warned against using the drug since 2007, when the first independent studies showing heart risks were published.

I want to point out something that irks me. In GSK's defense of the drug, particularly in the RECORD study, which had contradictory conclusions (there were adverse effects, no there weren't), they defend their product by saying that it doesn't do anything the label doesn't warn against, and other drugs kill people so their's isn't any worse.

"Congestive heart failure is a known effect of Avandia and other drugs in the thiazolidinedione (TZD) class and is prominently described in a boxed warning in current labels of both TZDs. As anticipated, rates of CHF in RECORD were higher in the group randomized to Avandia (61 events or 2.7 percent versus 29 events or 1.3 percent) (hazard ratio=2.10, 95 percent confidence interval=1.35 to 3.27). The difference was statistically significant. "

Many companies do this "well everyone else does it" or "but we warned you" defense. In the realm of people's lives, this is unacceptable behavior and rationalization. Avandia was supposed to extend people's lives and make them more livable, not kill them or give them another permanent condition to deal with. This attitude and vehement defense to the detriment of patients should be punishable by law, and not this wimpy "slap you with a fine" law, but dissolution of the company and arrest of those who didn't consider the health consequences of their product after they were smacked in the face with them.

The NYTimes reports that the Senate report, expected to be released on Monday states:

"G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk"

If the FDA doesn't pull Avandia, then they likely toll the bell for their own agency.