In a shocking statement given by a bi-partisan Senate report the diabetes drug Avandia has been blamed for tens of thousands of myocardial Infarctions (heart attacks). Not only that but the drugmaker GlaxoSmithKline (GSK) and the Food and Drug Administration (FDA) have known the risks for years.  GSK worked to keep them from the public, according to a Senate committee report released Saturday.

“It can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns,” the finance committee report said. “Instead, GSK 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.”

The 334-page report by the Senate Finance Committee not only criticized GSK, but also the FDA, saying that the federal agency that regulates food, tobacco and medications overlooked or overrode safety concerns found by its staff.

The Evidence

In 2007 The New England Journal of Medicine concluded a study that raised concerns that Avandia increased users’ heart attack risk. Two months later an outside panel of experts convened by the FDA voted 20-3 that Avandia did raise heart attack risk. But the panel voted 22-1 to recommend keeping the drug on the market.

To add to the overwhelming evidence there is even a report by the American Medical Association that says, “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone (Avandia) use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality,” the AMA journal wrote, “findings have potential regulatory and clinical implications.”

These studies were cited by the report and in light of this had some scathing commentary:

• Since the drug hit the market in 1999, Avandia has been linked to 83,000 heart attacks.
• Committee investigators say they found that GlaxoSmithKline experts verified an outside study showing the cardiac problem, but the company publicly attacked the findings as incorrect.
• Two FDA safety officials sounded a clear alarm in October 2008 writing, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [rival drug on market].” They concluded and trials comparing the two would be “unethical and exploitive.” Yet, the trial is still under way, the senators say.

The Evidence is Overwhelming but that’s Never Stopped Rhetoric

In the face of the findings of the Senate the FDA and GlaxoSmithKline remained defiant.

On Saturday GlaxoSmithKline said, “We disagree with the conclusions in the report,” spokeswoman Nancy Pekarek told CNN. “The FDA had reviewed the data and concluded that the drug should be on the market.”

Then today the FDA chimed in foolishly deciding to side with the company. They advised the public to not stop taking the drug and went further, “We feel that it is time for a thorough evaluation of all the cardiovascular risks with that drug,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a teleconference with doctors.

Something Fishy This Way Smells

Upon reading the New England Journal of Medicine study, the AMA Report, and the Senate report, diabetes drug Avandia is linked with tens of thousands of heart attacks, and drugmaker GlaxoSmithKline knew of the risks for years, but worked to keep them from the public.

So, to put it lightly, the FDA and GlaxoSmithKline has allowed hundreds of patients die of heart attacks since 2007 related to the drug and instead of choosing to stop, the FDA says it needs more time to study.

What is Their Motivation? Profit, What Else?

These are serious findings. That means that if executives are named then they could be liable to answer for the heart attack deaths of thousands of patients. As we have learned from many-a-corporate hearing through the years, generally, accountability is a grey area usually left to a single scapegoat.

But the FDA is a different story. They are a government agency with one purpose and one purpose only, to protect Americans. By deciding against the Senate recommendation and siding with the drug company they have opened themselves up to accusations of pandering to the rich drug companies and perhaps even corruption within the highest ranks of the bureaucracy.

Wrongful Death of Avandia Users

The drug companies have shown over and over that they are on the side of profit and their share holders first. The FDA consistently delays pulling drugs off of the market under the guise of further research and reviews. These delays put hundreds of millions of dollars in the pockets of the drug companies every month, not every year, every month. Protect yourself.

If you or a loved one is affected by Avandia or related type 2 diabetes treatments, it is also recommended that you obtain legal representation. Call Phillips Webster today to speak with an Avandia lawyer for a consultation and to review your legal options.