GlaxoSmithKline Reacts to Harsh Senate Report Regarding Avandia
After the Senate filed a report stating that GlaxoSmithKline downplayed the safety risks of their diabetes treatment drug, Avandia, the company reacted with a long White Paper Response explaining their side of the story.
The new press release immediately states that the Senate Finance Committee's January 2010 report on Avandia is inaccurate, unbalanced and refrains from giving a “complete view” of the information currently available on the drug. Also, Glaxo furthers their sentiment with the comment of being “mischaracterized” and that their efforts to monitor safety and efficacy of the diabetes medication has been distorted.
Glaxo feels the Senate's ineptitude to refer to new studies cited in the REPORT, such as ADOPT, DREAM and RECORD, are a direct sign of the allegations being incorrect and incomplete. Furthermore, there is record, according GSK, that they did contact and undergo many interactions with the Food and Drug Administration (FDA) regarding Avandia's health risks.
“Full consideration of the extensive measures GSK undertook to study Avandia prior to marketing approval, and FDA’s determination that the risk-benefit profile of Avandia is favorable, demonstrates that Avandia is an appropriate treatment option for physicians and patients in the treatment of type 2 diabetes.”
The White Paper Response goes into detail regarding the steps the company took in the beginning of the drug's development, during the drug's review with the FDA and after the diabetes oral treatment drug hit the shelves. The original senate report stated “it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns.” GSK states this can't be farther from the truth then outlined and dated all of the public studies they've released regarding the heart risks.
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