FDA overrules recommendation to pull deadly Darvocet pain killers

WASHINGTON (AP) — The government is letting the painkillers Darvocet, Darvon and their generic cousins stay on the market but ordered stronger warnings against deadly overdoses on Tuesday.

The Food and Drug Administration’s decision puts the U.S. in contrast to Britain — which banned the drugs several years ago, citing a trail of suicides and accidental overdoses — and Europe’s drug regulators, which just recommended that European Union countries do the same.

Known generically as propoxyphene, the 50-year-old prescription drug is widely used in the U.S. even though doctors consider it a weak pain reliever. The consumer watchdog group Public Citizen had petitioned the FDA to ban it here, too, saying the small benefit didn’t justify a risk that was adding up to several hundred deaths a year. In January, the FDA’s scientific advisers narrowly agreed.

But the FDA overruled its advisers Tuesday, at least for now. It ordered that a stern boxed warning be placed on the drug’s label and that patients soon start receiving a special pamphlet with every bottle that stresses the risk of taking too much.

Yeah, what’s a few hundred deaths compared to Ely Lilly’s profits?  What do scientists know compared to pharmaceutical-industry-installed government bureaucrats, anyway?

(Reuters) In his letter, (Congressman Henry) Waxman said a June 15, 2007 e-mail from then FDA Chief Counsel Sheldon Bradshaw showed he planned to forward a list of agency priorities to Deputy Secretary of Health and Human Services Tevi Troy. Both have ties to the pharmaceutical industry.

The initiatives also appear to have bypassed normal regulatory channels so they could be implemented sooner, Waxman said.

Before joining HHS, Troy worked for two think tanks with drug company ties, Waxman said, adding that Troy’s brother works as a lawyer for GlaxoSmithKline Plc.

(Now, admittedly, that was the Bush Admin’s FDA.  But this Darvocet story makes me doubt the leadership of Obama’s new commissioner, Dr. Margaret Hamburg, especially when TIME Magazine noted:)

Importantly, Hamburg is believed to be an acceptable choice to both the pharmaceutical industry and consumer advocates, a narrow tightrope any nominee must walk to win Senate confirmation.

Why does the head of the agency charged with regulating the pharmaceutical industry need to be acceptable to the industry she’s regulating?  Are we going to ask death row inmates their opinions of the new warden?

This is the same FDA that prohibitionists keep telling us has never and would never approve cannabis for medicinal purposes because it’s too gosh darn dangerous.  Hey, what if we package it with a special pamphlet and a stern boxed warning on the baggie: “Warning: taking too much cannabis may lead to the risk of overeating Cheetos, enjoying jam bands, and fits of giggling.”