IT HAS taken a while, but on 6 June the US Food and Drug Administration announced the diabetes drug Avandia will soon come with a prominent 鈥渂lack box鈥� warning about the risk of congestive heart failure. Experts reviewing the drug for the FDA first called for one over a year ago. Some say the delay is another example of industry versus science, with science the loser.
聯Some say the delay is another example of industry versus science, with science the loser聰
An oral drug that lowers blood sugar, GlaxoSmithKline鈥檚 Avandia has been used by patients with type 2 diabetes since 1999. Concerns over possible heart-related side effects were raised by diabetes specialists in 1999, and again last year by FDA reviewer Rosemary Johann-Liang, who says the FDA ignored her proposal for a stronger warning. The FDA is investigating her claims.
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With drug makers pushing for speedy approvals, science is often sacrificed and reviewers鈥� opinions stifled, says Francesca Grifo, director of the Scientific Integrity Program at the Union of Concerned Scientists in Washington DC.
Legislation to boost the evaluation of drugs鈥� safety after they go on sale is being debated in the US House of Representatives this week.
