Avandia Woes Mount Ahead of FDA Hearing

Agency flags flawed study, may ban diabetes drug
By Nick McMaster,  Newser Staff
Posted Jul 9, 2010 5:55 PM CDT
A pharmacist displays three Avandia pills at Maximart Pharmacy in Palo Alto, Calif., Wednesday, June 30, 2010.   (AP Photo/Paul Sakuma)
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(Newser) – As the FDA prepares to consider whether to ban Avandia, agency scientists have discovered another problem with the diabetes drug: flaws that disqualify a clinical study sponsored by its maker. The trial, organized by GlaxoSmithKline, sought to evaluate the relative heart risks of Avandia and two other diabetes drugs, but was an "open label" trial, meaning the researchers and patients knew which drugs they were getting, USA Today reports.

The study also omits information about which subjects died, notes an FDA scientist who evaluated the GlaxoSmithKline study for the agency's review. The FDA is looking at Avandia for the second time in only three years: In 2007, an agency panel ruled the drug did increase the risk of heart disease but also decided its benefits warranted keeping it on the market.

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