FDA didn’t pull diabetes drug despite knowing it caused hundreds of heart attacks

Did the Food and Drug Administration knowingly allow an unsafe diabetes drug to remain on the market?

The NY Times obtained confidential government reports concluding that if every diabetic currently taking Avandia were given the alternative drug Actos instead, about 500 heart attacks and 300 cases of heart failure would be prevented every month. Avandia, once the world’s biggest-selling drug, was linked to 304 deaths during the third quarter of 2009.

A bipartisan Senate investigation is expected to release its report today that will criticize the makers of Avandia, GlaxoSmithKline, for failing to warn patients about the potential deadly consequences of taking the drug.

Scrutiny is also being focused on how the FDA had been running things over the past decade since it had known about this problem for years. As early as 1999, experts were warning that Avandia had heart risks and one report by FDA officials flatly concludes that the drug should be removed from the market.

The Senate panel, which poured through 250-thousand internal documents, says executives for GlaxoSmithKline –quote– “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.”

It is very simple, really. The drug industry is willing to kill people for a profit. This may well be part of the reason Americans, on average, die more than three years earlier than the people in Canada and Australia.

Think about it: 304 deaths in 3 months. The Taliban has only managed to kill an average of 115 Americans a year in Afghanistan but GlaxoSmithKline can kill that many in about 5 weeks. It proves that if you want a job done right just use that good ol’ American know-how, and greed.

This is another example of how the free market gets away with murder –literally, in this case– when government fails to engage in proper and careful regulatory exercise.

This is what happens when you put business profits ahead of public safety. Only when the damage has become catastrophic has the FDA seen fit to take action.

There is something in medicine called the “precautionary principle,” which dictates that drugs or other treatments must be proven safe prior to being released to the public. Instead, what we’ve had is a policy that a drug must be proven dangerous in order to be removed, which tends to safeguard the drug company and its economic well being, which evidently was of considerable concern to the controversial FDA commissioners (and deputy commissioners) appointed by the previous administration. (No surprise, given the influence of Big Pharma).

About The Author