A federal review panel has recommended that Avandia, the controversial diabetes medication linked to heart attack risk, either be removed from the market or allowed to remain on the market with severe restrictions, the New York Times reported.
As our New York City medical malpractice attorneys have reported, this drug has had a long and sorted history. Most recently, we reported that the majority of studies that favored the drug had been written by doctors and other experts who were paid by the company. Consumers continue to be at risk from dangerous pharmaceuticals and medical products. Companies spend billions in marketing and developing drugs and devices and the government seems to be paying little attention to the potential dangers until well after the fact.
Nearly a decade after Avandia went on the market -- and three years after a Cleveland Clinic physician raised the alarm -- some government officials concluded Avandia was likely causing about 300 deaths a month and should be pulled from the market. Yet even that recommendation was only made public after the Times obtained the government report.
This week, a federal advisory panel split on what recommendation should be made to the Food and Drug Administration. Twelve members voted to withdraw it from the market; 10 favored increased warning labels and restrictions; 7 voted for increased warning labels only; and 3 said it should continue to be marketed as is.
Meanwhile, information was revealed during the hearings that the company knew of the drug's reported dangers for years and did not reveal the information to regulators or the public.
In the fall of 1999, makers of Avandia secretly studied whether it was safer than a competing pill. Not only did it prove no better, it actually proved that Avandia was riskier to the heart. Instead of publishing the results, it spent the next decade trying to cover them up, according to the New York Times. In most cases, failure to release the results would be a violation of law, the Times reported.
The heart risks of Avandia did not become known until 2007. In ensuing months, executives at the drug's maker, GlaxoSmithKline, were forced to admit they knew of the drug's potential risks since at least 2005.
The documents obtained by the Times suggest that the company knew of the risks since at least 1999 and hid them because of the potential loss of $300 million a year in revenue.
Make no mistake about it: Pharmaceutical sales is big business, perhaps the biggest business. Billions are spent marketing and developing drugs. Millions more are spent compensating well-paid sales people to push the drugs at doctors offices and hospitals. When patient care is lost in the mix, serious injury or death may result. Those harmed should seek experienced, aggressive and knowledgeable legal representation to fight for their rights.

No Comments
Leave a comment