Avandia, the GlaxoSmithKline anti-diabetes drug that could be taken off the market by the US Food and Drug Administration, is yet another illustration of the difficulties facing pharmaceutical companies in refilling their pipelines with blockbuster drugs.
Avandia’s fate seems already to have been sealed, since sales have been dropping since a 2007 study found an associated risk of heart attacks. If it was removed from the market, it would be the highest profile such event since Merck withdrew its painkiller Vioxx in 2004 on similar concerns.
As Andrew Jack noted in the FT, David Graham, an FDA researcher who found an increased risk of heart attacks among patients taking Vioxx has now found higher risks of strokes and heart failure among elderly patients taking Avandia.
There are conflicting views about the drug at the FDA, which will mull the question of whether it should be withdrawn this week. GSK still maintains that Avandia is safe. Still, it seems very likely that the drug will be withdrawn, given the controversy.
The Vioxx affair led to a revamping of after-market studies of drug safety (clinical trials conducted after a drug is approved and on the market) and Avandia is among drugs now under closer scrutiny.
The difficulties of getting drugs through the pre-release pipeline are already considerable, with half of drugs that reach Phase III trials (the last phase) failing tests for effectiveness. That has steadily raised the costs of developing new treatments.
With heightened scrutiny and greater legal risks after drugs are approved, the economics of producing new blockbusters are now under further pressure.
