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Senate Report: Grave Concerns over Avandia, FDA

By Tanya Roth, Esq. | Last updated on

Move over Merck, Americans are about to have a new drug company to worry about. According to CNN, late last week the Senate Finance Committee released a 334 page report, two years in the making, taking both the FDA and GlaxoSmithKline to task for what it found to be an unacceptable risk of heart attack linked to use of the drug Avandia, a medication used to treat diabetes.

According to CNN, the Senate's report finds that the FDA "overrode or downplayed" staff concerns over the links between the drug and increased occurrences of myocardial ischemia (blocked blood flow and oxygen to the heart) or myocardial infarction (heart attack) in patients taking the drug. According to the Senate report, FDA scientists estimated in July 2007 that Avandia was associated with approximately 83,000 heart attacks since coming to market. The report goes on to claim that had the company taken the risk more seriously, some of the heart attacks could have been avoided.

CNN writes that respected American medical journals such as The New England Journal of Medicine and The Journal of the American Medical Association had called the drug's safety into question by 2007.

Representatives from the GlaxoSmithKline respond that the FDA did thorough research and still found the drug to be safe enough to go to market. "We disagree with the conclusions in the report," company spokeswoman Nancy Pekarek told CNN. "The FDA had reviewed the data and concluded that the drug should be on the market." Seven clinical trials on the drug prove that it is not linked to heart attacks, Pekarek added.

GSK spokeswoman Pekarek when on to say that the data used in the report took place "years ago" and represents no new findings. 

FDA Commissioner Margaret Hamburg said in a statement, "I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved."

CNN writes that the Senate report was developed by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA and several research institutes. Committee investigators also conducted numerous interviews and phone calls with the company, the FDA and anonymous whistleblowers.

In a time of increasing partisanship, the report was signed not only by committee Chair, Democrat Max Baucus, but also by ranking minority member, Republican Senator Chuck Grassley.

For the full text of the report, click here.

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