Why didn’t the U.S. Food and Drug Administration crack down on Avandia sooner? The killer diabetic drug stayed on the market for years when mounting evidence showed it could cause fatal heart attacks.  

In a perfect world, the FDA would protect Americans from bad drugs like Avandia. In the real world,  personal injury lawyers are the best line of defense against a federal agency that is proving powerless to regulate drugs that kill Americans.  

Questions about the FDA’s lack of supervision of big pharmaceutical companies need  answers. Lives are on the line.

According to The New York Times, in 2006, 13.3 million prescriptions were written for Avandia amounting to $3.2 billion in U.S. sales, an average year’s [profits before news surfaced that it might cause heart attacks.  That means thousands took Avandia and thousands had heart attacks due to the drug maker’s aggressive marketing and the FDA’s lax supervision.     

The sheer number of Avandia lawsuits filed against GlaxoSmithKline, the London-based company that makes the drug, and the way that company has jumped to keep them from going to trial, lends weight to the charges against it. Last year, Congress held investigative hearings on GSK and the FDA that focused on Avandia. A review of the facts reveals a  pattern of deception and fraud.   

The evidence has been around a long time. In 1999, an FDA scientist told his supervisors that Avandia “appeared to increase the incidence of congestive heart failure...,” Time Magazine revealed that news last December in an article questioning the FDA’s attitude toward Avandia.  

According to a New York Times report in 1999, GSK threatened two scientists who warned of Avandia’s link to heart attacks in papers they had published in scientific journals. In 2003, GSK’s own internal studies showed that diabetics taking Avandia had more heart attacks than patients taking placebos. In 2005 and again in 2006, the company’s own studies showed that Avandia increased the incidence of heart attacks in diabetics.     

In 2007, cardiologists on a a GSK advisory board told the company’s executives that they found the 2005 and 2006 company studies disturbing.That same year, the nationally respected Cleveland Clinic linked Avandia to heart attacks in diabetics.  In 2008, reports of problems with Avandia were found in internal FDA memos. It turns out, the federal agency had known that the drug could cause heart attacks since 1999.    

In 2010, a report in the New York Times linked Avandia to 304 deaths in the third quarter of 2009. In February, the Senate Finance Committee slammed the FDA for overlooking safety concerns about Avandia. The committee’s report found that Avandia was linked to “tens of thousands of heart attacks,” and that GSK had worked for years to keep that fact from the public. It confirmed that the FDA had known about the drug’s problems for years.   

Last fall, the FDA finally put restrictions on Avandia. It ruled that the drug can only be prescribed for diabetics whose disease can’t be controlled with other medications. Based on the same set of facts that were available to the FDA about Avandia, the European Medicines Agency took it off the market.    

This month, GSK  paid $250 million to resolve nearly 6,000 Avandia lawsuits, a move that prevented the first ever trial over claims it can kill users, according to Bloomberg News. GSK has also agreed to pay $460 million to “resolve allegations it didn’t properly warn doctors and consumers” about Avandia’s risks. GSK is “taking a $3.5 billion charge to cover expenses linked to investigation and suits over Avandia, Bloomberg News reported. The reserve brings to $6.4 billion the amount the drug maker has set aside in the past year for legal costs tied to Avandia.

The Glaxo story reminds reporters, personal injury lawyers, public watchdogs and victims of the Vioxx cases. The FDA insisted for months that it knew nothing about the popular arthritis pill’s connection to heart attacks. In March 2005, an FDA official finally acknowledged “lapses” in the federal agency’s oversight of the drug. It’s estimated that 55,000 patients may have died from heart attacks and strokes after taking Vioxx. The FDA finally pulled it off the market  in 2004. Critics cite the many FDA recalls in recent years as proof the “fox is guarding the hen house” when it comes to the federal agency’s oversight of big pharmaceutical companies.