FDA restricts access to Avandia
TEXT OF STORY
Bob Moon: The diabetes drug Avandia got a simultaneous Euro-U.S. smackdown today. Avandia has been tied to an increased risk of heart attacks. European health authorities announced they’ll ban GlaxoSmithKline’s once-blockbuster drug outright. The U.S. Food and Drug Administration will allow its use for patients with no other treatment options.
Marketplace’s Adriene Hill reports on how this decision might affect other drug approvals.
Adriene Hill: Avandia was once the darling of the diabetes pharma-industry. But when a study tied the drug to an upped risk of heart attacks, the shine faded fast.
Morningstar analyst Damien Conover thinks today’s news isn’t as bad as it might seem, in part because recent news has been really, really bad.
Damien Conover: A lot of the damage to this drug has already been done.
Conover says Avandia sales have already dropped 75 percent. He thinks they’ll continue to taper off, but he thinks there’s a more significant Avandia-related change in store for the pharmaceutical industry.
Conover: Companies that are developing drugs for diabetes, they’re probably going to have to do bigger trials that cost more money and will be harder to bring new medicines to the market.
Avandia’s troubles have already significantly changed the way diabetes drugs are regulated. Dr. Thomas Donner is a diabetes expert at Johns Hopkins. He says Avandia works by lowering blood sugar, but after the drug’s troubles came to light, regulators decided they needed to judge similar drugs by more than just that single criterion.
Dr. Thomas Donner: The Food and Drug Administration, with pressure from a lot of sides — especially from the public — said we’re going to put that extra criteria on medications, that long-term studies be performed.
Donner says the new, long-term studies watch for cardiovascular risks like heart attacks and strokes: The main causes of death for people with Type 2 diabetes.
I’m Adriene Hill for Marketplace.
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