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On August 26, 2010, the U.S. Food and Drug Administration (F.D.A.) greatly restricted GlaxoSmithKline’s drug Avandia, or rosiglitazone.  Avandia, once widely used throughout the world in the treatment of type 2 diabetes, has been subject to controversy almost as long as it has been legal.  Approved by the F.D.A. in the late 1990s, Avandia has been cited for serious side effects including heart attack, heart failure and, most recently, liver failure. Numerous studies, reports and petitions, in addition to an estimated 13,000 lawsuits pursued by St. Louis Avandia lawyers, have finally resulted in the federal restriction.  However, the prominent consumer advocacy group Public Citizen asserts that the lack of a complete ban on Avandia indicates the F.D.A.’s subservience to corporate interests.  A federal ban on Avandia, such as was issued in the European Union (also on August 26, 2010), would no doubt further the efforts of Avandia lawyers to hold G.S.K. accountable for thousands of cases of wrongful death and personal injury, but could also prevent many untimely deaths in the future.  Therefore the question begs: Why has the F.D.A. stopped short of a full ban?

Successful St. Louis Avandia lawyers have reached settlements in at least 11,500 Avandia lawsuits by showing that the corporation (G.S.K) withheld evidence linking Avandia to heart disease and heart attack.  Three studies released in 2007 – one published in the New England Journal of Medicine, another released by G.S.K. which had been conducted by not made public three years earlier, and a third conducted by the F.D.A. – all indicated that Avandia raised the risk of myocardial ischemia (heart disease) in patients.  No clear evidence of heart failure was presented through those studies, which were all short-term in nature and therefore could not be anticipated to detect severe health impacts that result from long-term use.  Clear indication of heart disease should have led G.S.K. and the F.D.A. to initiate long-term research at the time.  Instead, a long-term study conducted by other researchers was published in the Journal of the American Medical Association (JAMA) stating Avandia’s connections to heart attack. 

In 2005 and 2006, G.S.K also analyzed and reviewed existing studies of Avandia and found that the drug increased the likelihood of heart problems by one-third.  G.S.K.’s delay in releasing the outcomes of the 2004 study and the 2005-2006 meta-analysis, alongside the Senate Finance Committee’s full review of 250,000 internal company documents, shows that the company was remiss to the release of vital information that linked Avandia to serious health risks as early as 2003, meanwhile continuing to market the drug aggressively around the world.

St. Louis Avandia lawyers and others also allege that G.S.K. suppressed disparaging remarks made of Avandia.  In one example, a professor of medicine at the University of North Carolina, Dr. John Buse, was threatened by the company when he presented information that linked Avandia to heart risks.  He later formally agreed not to state his worries about Avandia in public settings.  

Despite evidence that G.S.K. had evidence of  and suppressed Avandia’s severe health risks for a lengthy period, the G.S.K. drug has not been banned from the U.S. market.   This reality calls into question the effectiveness of the F.D.A.’s regulatory arm.  Due to its failure to protect U.S. consumers from a money-grubbing corporation, the F.D.A. should be examined for possible corruption.

The case of Avandia brings up important issues regarding the FDA and the drug approval process.  A product of GlaxoSmithKline (GSK), Avandia is used for treatment in type 2 diabetics.  Avandia in many cases appears to be a useful treatment. Avandia is an insulin sensitizer that works to moderate levels of glucose in the blood.  It has been widely asserted that the drug causes a heightened risk of serious health problems such as stroke and heart disease.  The data demonstrating this connection is controversial, with some studies asserting that Avandia increases the risk for heart disease by 43% and for stroke by 27%.  GSK continues to manufacture Avandia despite settling on more than 11,500 Avandia lawsuits, which could cost GSK somewhere between $1 billion and $6 billion. In 2009, Avandia sales had declined significantly but still totaled $1.2 billion worldwide.

The FDA’s mission is clear: to protect the safety and public health of U.S. residents through the regulation of food and drug products.  However, as exemplified by Avandia, the application of this mission is difficult and wrought with controversy in a high stakes environment which where strong pressures come from powerful pharmaceutical companies.  A 2010 Time article uses the Avandia case as evidence that the FDA is a failed institution.  The article states that, “Congressional reports revealed that GSK sat on early evidence of the heart risks of its drug, and that the FDA knew of the dangers months before it informed the public.”  This type of case raises the question of how much power large conglomerate corporations exert over the regulatory functions of the FDA.  We know that one member of the voting panel was a paid GSK spokesperson; we don’t know if other members were also unfairly influenced.

Even within the FDA, opinions have varied, ranging from leaving the drug on the market as is to banning it completely. No such controversy exists within the European Medicines Agency, who voted to ban Avandia in Europe on September 23, 2010.  In comparison, the FDA appears divided, slow, and ineffective.  Meanwhile, affected consumers continue to file Avandia lawsuits for personal injury and wrongful death.

To say that this is the case of evil corporations versus public health would vastly oversimplify a very complicated issue.  Firstly, the dangers are not clear, with different sources report contradicting data.  Secondly, there is difficulty calculating whether the increased risks outweigh the benefits that patients receive from the drug.  Several prominent medical organizations urge patients currently on Avandia to continue using the drug.  This recommendation comes from a belief that the risks of not using the drug are more severe than the potential heightened risk of heart disease and stroke.

The numbers of people filing an Avandia lawsuit will continue to grow.  And, hopefully the case of Avandia will spur more investigations into corporate influence on the FDA’s decisions.  However, just as we would hope that GSK would carefully test their drugs before releasing them, we should strive to get all of the facts before forming opinions.