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.