Diabetes Drug Avandia On Trial After Heart Attack Risk Allegations
Posted: Thursday, September 2nd, 2010 at 10:54 am
The diabetes drug Avandia will be the subject of two days’ worth of testimony in front of a Food and Drug Administration advisory panel, which will determine whether or not to remove Avandia from the market.
Avandia, also known as rosiglitazone, is a drug that helps manage type 2 diabetes by controlling blood sugar levels. It has been the subject of controversy—and lawsuits—since a 2007 study published in the New England Journal of Medicine linked Avandia to an increased risk of heart attacks and strokes. After a review, federal regulators made the decision to allow the drug to remain on the market, but mandated that the pharmaceutical company responsible for manufacturing Avandia, GlaxoSmithKline, add more warnings on the drug’s packaging.
Yet allegations on the part of former FDA officials, as well as company insiders, say that the company was aware of the medication’s risk long before the damaging study came out. Studies conducted by GlaxoSmithKline, additionally, have been shown to be flawed and biased by several independent experts. One in particular, known as RECORD, has come under fire because its results, in sharp contrast to the results of the New England Journal of Medicine study, said that Avandia caused no increase in the risk of heart problems.
Although GSK has maintained that the drug is safe, and that several of their trials provide proof of its safety, new documents have surfaced that point to a possible cover-up on the part of the pharmaceutical giant. Senator Charles Grassley (R-Iowa) has sent internal company memos and other documents to the FDA, according to the Wall Street Journal, that implicate GSK by stating that damaging data about Avandia not be released to the general public or federal regulatory agencies.
The FDA has also said that GlaxoSmithKline failed to follow up on reported health problems and even patient deaths said to be caused by Avandia.
Avandia came on the market in 1999 and has been extremely profitable for GSK, yielding $3 billion in profits in 2006.
GlaxoSmithKline is facing over 13,000 lawsuits worldwide centering on Avandia, and has already settled $60 million worth of legal challenges. The first cases to come through the U.S. court system will be heard by a Philadelphia court in October.
After the advisory panel hears all of the evidence, it will most likely either add additional warning labels to Avandia’s packaging, restrict the doctors who are allowed to prescribe it, or pull the drug from the market altogether.
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