GlaxoSmithKline has not thrown in the towel over their diabetes drug Avandia yet despite study after study coming out showing a serious heart attack risk associated with the drug. They’re waiting for the Food and Drug Administration (FDA) to do it for them apparently, and up to this point the FDA has decided to put the towel over their eyes and nap for a while on the issue.

Glaxo and Avandia have been taking a pounding since 2007.

• 2007 – New England Journal of Medicine – Makes a decisive connection between Rosiglitazone (the active ingredient in Avandia) and an increase in heart attacks and death caused by heart attacks.
• 2007 – FDA asks Glaxo to Conduct TIDE study -  to perform a cardiovascular safety trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), to compare Avandia to other diabetes treatments such as ACTOS (piolglitazone).
• 2008 – Journal of the American Medical Association – Links a long term risk of Rosiglitazone and general cardio-events such as such as heart attacks, heart disease and complications related to heart disease.
• Feb. 2010 – Senate Finance Committee – The Senate got into the mix and released a 374 page report accusing Glaxo of a lack of ethics with regards to their conduct regarding and estimated that as many as 83,000 patients have had heart attacks due to taking Avandia. Galxo rebuts with a 30 page reply citing other research showing no cardio connection.
• March 2010 – Study Reveals 94% of Glaxo Avandia Research Bogus – After reviewing 202 cases, the British Medical Journal found that almost all research conducted on the drug was either paid for directly or indirectly by Glaxo. None of those studies found a heart attack connection.
• April 2010 – House of Representatives Appropriations Subcommittee – Major review makes FDA seriously consider shutting down TIDE study. Instead they promise serious review of data. Foot dragging continues.
• June 2010 – FDA Whistleblower Reveals Internal Study – Whistleblower reveals FDA was sitting on internal study showing that Avandia increased the risk of:

Stroke by 27%

Heart Failure by 25%

Death by Heart Failure by 13%

Death by Acute Myocardial Infarction (AMI) 11%

AMI, Stroke, or Death by 14%

AMI, Stroke, Heart Failure or Death by 17%

The whistleblower was on June 14^th. The FDA still chose to drag their feet. The problem is that patients are dying from heart attack and stroke on a daily basis because of the drug and yet they still do not recall it. This leaves serious questions as to the motiviations of the FDA.

Avandia Study

The Journal of the American Medical Association study involving more than 35,500 patients, found Avandia significantly raises the chances of a heart attack. It was a “meta-analysis” of 56 trials involving people taking Avandia or other diabetes drugs. It found those taking Avandia were 28% to 39% more likely to have a heart attack, although the study concluded patients were not any more likely to die.

This study also increased the estimated number of heart attacks associated with Avandia from the SEC report 83,000 to almost 150,000 since 1999. Almost double.

The second study released today was the study that was broken by the whistleblower. It was conducted by researchers at the FDA and the U.S. Centers for Medicare and Medicaid Services. They compared patients who took Avandia with those who took Takeda Pharmaceutical’s drug Actos, a rival in the same class. They found people taking Avandia had 1.25 times the risk of heart failure compared with those taking Actos, 1.27 times the risk of a stroke and 1.14 times the risk of dying.

“What we’re reporting in this study today was available to the FDA in 2007,” said David Graham, a doctor at the Center for Drug Evaluation and Research at the FDA in Maryland. “But the agency waited three years for more definitive proof of harm even though roughly 10 studies have shown Avandia to be less safe than its alternative.”

JAMA released an article with their study explaining the FDA’s dilemma between pulling the drug and conducting more research. In the article by Dr. Juurlink called “Rosiglitazone and the Case for Safety Over Certainty,” the author candidly explains the FDA’s position, but staunchly falls on the side of patients.

In it he says, “One option is to recommend removal of rosiglitazone from the US market and the termination of the TIDE trial. Under this scenario, GSK loses, but clinicians and patients still have pioglitazone as an option, and public safety is prioritized over the desire for certainty about the safety of rosiglitazone relative to pioglitazone.”

He goes on to say, “A second option is to do nothing for now other than await the results of the TIDE trial. If the FDA elects this course of action, regulators around the world are likely to follow their lead, and millions of patients will continue to receive rosiglitazone (assuming GSK continues to market this drug). Under this scenario, the desire for certainty trumps safety, patients may lose, and an ethically questionable trial will continue to seek participants who, it seems, may not fully appreciate the potential risks of participation.”

When stated like that any compassionate human being would find that the only future course of action is to pull the drug from the market. Unfortunately, profit trumps rational and Glaxo is currently making as much as $150 million per month off of the drug.

Avandia Lawyers

Around 13,000 lawsuits have been filed nationwide, with plaintiffs accusing Glaxo of failing to warn patients about the serious risks of not only heart attack, but also stroke, heart failure, bone fractures, vision loss, and death associated with the medication.

Many of these lawsuits have been consolidated into large class action lawsuits in states throughout the nation. They also include wrongful death lawsuits and defective drug lawsuits brought by victims and their families that have suffered due to the negligence of Glaxo.

Recently about 700 of these lawsuits were settled for what legal experts consider a very low amount of around $60 million. That translates to less than $80,000 per patient. Far less than what Glaxo has allocated into escrow for lawsuits which totals $2.9 billion. If they settle the rest of the lawsuits for so little the will settle for only $1.1 billion in total and thus the deaths of thousands of patients will only end up costing them less than 8 months profit.

This unethical and deceptive behavior cannot go unpunished. The remaining lawsuits are still tallied in the billions of dollars and reflect the real problems suffered by patients that sought treatment for their diabetes and ended up severely injured or dead.

If you are an Avandia user or the loved one of an Avandia user who has suffered a loss of a loved one or serious personal injuryrelated to taking Avandia you may be entitled to compensation for your pain and suffering. Phillips Webster is a team of experienced defective drug attorneys with a proven track record of successful defective drug litigation. Call them today for a free consultation and to find out your legal rights as a patient.

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