As expected, an FDA advisory committee today ignored the urging of many leading researchers and consumer advocate groups and even one of its most influential scientists and voted 20-2 to keep the diabetes drug Avandia on the market. The FDA is not required to follow this recommendation but, almost invariably, it does.
Yesterday, Dr. David Graham, a leading FDA scientist and one of the FDA officials widely respected by both pharmaceutical companies and patients’ rights advocates, said Avandia should be removed because of the risks and because Avandia was no better at controlling blood-sugar levels than similar diabetes medications such as Takeda’s Actos (which might also increase the risk of heart disease according to a just-published study).
Should Avandia be taken off the market? I don’t know. Certainly, if a patient with serious life-threatening diabetes is having a great result with Avandia, maybe the risk does outweigh the benefits for that particular patient. Perhaps the FDA should restrict Avandia for use in selected patients and brand Avandia with prominent and meaningful warnings referencing the studies that point to a greatly increased risk of a heart attack. But this is a different question than the real question Avandia lawyers are looking at with clients who have suffered a heart attack or stroke while on Avandia: what are the risks of Avandia are when did GlaxoSmithKline learn of these risks?