Monday, September 08, 2008

FDA sued for slow-footed response to petition

Two years ago, the group Public Citizen filed a petition to the FDA asking that it ban the prescription painkiller propoxphene. They're still waiting for a response from the slow-footed government agency – which is why they've decided to sue.

Public Citizen says that the agency broke the law by not ruling on their petition within six months.

The requested ban isn't without merit. Propoxphene (marketed as Darvon and Darvocette) has been linked to the accidental deaths of upwards of 2,000 people since 1981. It can be addictive and can cause serious side effects like slowed heartbeat and other cardiac issues. It's even been pulled off the market entirely in Britain because of its links to accidental deaths.

And all for what? The drug isn't even that effective. Public Citizen's Dr. Sidney Wolfe unearthed studies claiming that over-the-counter ibuprofen is more effective at treating most types of pain than propoxphene.

Public Citizen is definitely fighting the good fight. I always admire the pluck of groups that regularly line up to play David in the face of the government's Goliath. And while I admire them for holding the FDA's feet to the fire over their petition, I think we all know how the FDA will rule on that petition: they'll decline it.

Propoxphene has been around for a while and is considered one of the weaker prescription painkillers, and – this is the important part – it's one of the most widely prescribed generic drugs, with over 22 million prescriptions in 2007.

In other words: ka-ching!

Obviously, Big Pharma is making big bucks off the marketing of propoxphene, so what do you think the odds are that some petition will move the FDA to act? Even as I write this, I can tell you're slowly shaking your head. Unfortunately, we all know how this is going to turn out. But I'll keep an eye on this story anyway…

Always hypercritical of the hyper incompetence of the FDA,

William Campbell Douglass II, M.D.

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