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 A report has been released by the US Senate finance committee which is highly critical of GlaxoSmithKline's (GSK) handling of research into the heart attack risks of type 2 diabetes drug Avandia.
FDA scientists estimate that Avandia has caused at least 83,000 heart attacks in the US between 1999 and 2007. The Senate report states that "had GSK considered Avandia's potential increased cardiovascular risk more seriously when the issue was first raised in 1999 ... some of these heart attacks may have been avoided."
Instead, the report finds that "GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk."
The competing drug referred to is Actos (pioglitazone), made by Eli Lilly. The New York Times claims that confidential government reports it has obtained "say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart."
GlaxoSmithKline disagrees with the report, saying it "cherry-picks information from documents, which mischaracterizes GlaxoSmithKline's comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients."
Why is this Important?
Around 40,000 Australians use Avandia, according to The Australian.
In 2008, the Australian Theraputic Goods Administration ( TGA) updated the product information on Avandia. At that time Diabetes Australia issued the following statement:
"Diabetes Australia is advising people who are taking rosiglitazone (Avandia) or rosiglitazone/ metformin (Avandamet) to manage their diabetes to not stop using this medication but to make an appointment with their doctor to review their treatment as soon as possible." Links
Article in The Australian
http://www.theaustralian.com.au/news/nation/diabetes-drug-risks-hidden/story-e6frg6nf-1225832754558
Diabetes Australia Statement
http://www.diabetesaustralia.com.au/en/News--Events1/News/Response-to-changes-to-information-for-Avandia-and-Avandamet/
Article in New York Times
http://www.nytimes.com/2010/02/20/health/policy/20avandia.html
US Senate Report
http://finance.senate.gov/press/Gpress/2010/prg022010a.pdf
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