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Ignoring and even publicly marginalizing evidence of increased heart attack risk in favor of pharmaceutical revenues, the Food and Drug Administration advisory panel recommended Wednesday that the controversial diabetes drug Avandia remain on the market — with tighter supervision and increased warnings about the danger of heart attacks. Perhaps due to short term memory loss, but this is an all too similar scenario to the Viagra and Fen Phen fiasco of some years back.
While "Advisory" recommendations are not binding the FDA is expected to take at least several weeks to consider a response. While some truth was revealed during the hearings, it is of interest that it may well be the panel's inability to quash its own expression of increased concern that is likely to further reduce doctors' reliance on what was once the leading "wonder" drug of choice for treating Type II diabetes.
Desperately attempting to let it be seen to try and balance potential risks and benefits for individual patients, 10 members of the 33-member panel voted to keep Avandia on the market under close supervision, seven voted to permit continued marketing, but with stronger label warnings, and three favored the status quo. One member abstained. Twelve members voted to remove the drug from the market. not enough I am afraid to do much good - though perhaps Avandia's inevitable fate will be better expedited than the pharma giant's short lived predecessors.
Several panelists said they were persuaded to vote in favor of limiting or eliminating Avandia because another drug, Actos, works as well but has not shown as many side effects. Perhaps it is time to follow the money...
Reliance on Avandia has dropped sharply in recent years as evidence began to accumulate linking it to increased risk of heart attack.
At the peak of its popularity in 2006, 13 million prescriptions were written, according to IMS Health, a pharmaceutical market research company. By 2009, the number had declined to about 2.6 million, the firm said. GlaxoSmithKline, the drug's maker, said about 550,000 Americans took medications containing Avandia in the last year.
Status Quo Wins Out
The votes by a majority of the committee's members essentially affirmed a recommendation by a similar panel in 2007 that concluded Avandia could increase the risk of heart attacks but nonetheless should remain on the market.
Avandia is said to control the blood sugar by increasing sensitivity to insulin, an important marketing premise to Type II Diabetics. Not fully documented but perhaps a nice thought or theory.
Cleveland Clinic cardiologist Dr. Steven Nissen, whose 2007 analysis of several Avandia studies touched off much of the controversy over the drug, found that the drug increased the risk of heart attack by roughly one-third compared with recipients of other medications or a placebo which, coupled with other submissions should have provided the FDA with sufficient documentation to withdraw the drug if they were completely impartial.
Last month, an updated analysis by Nissen published in the Archives of Internal Medicine confirmed that finding.
Yet another report overseen by FDA researcher David Graham and published in the Journal of the American Medical Assn., found that Avandia boosted the chance of stroke by 27% and heart failure by 25% compared with Actos, made by Takeda Pharmaceuticals North America.
But GlaxoSmithKline pointed to other studies that it said showed that rates of cardiovascular events were comparable between Avandia users and people taking other diabetes medicines. What? What kind of justification logic is that? because our product increases the risk of heart attack like other drug company products, it's OK?
Go figure.
Stay well and in good health!
