Petty FDA office politics might be very bad for your health

Dysfunction junction

A recent Wall St. Journal article refers to the FDA as “the U.S. drug-safety agency.”

I doubt the WSJ writer was trying to be funny. But that’s hilarious.

The article looks at a surprisingly public interoffice squabble at the FDA. It’s an important showdown because it reveals the shocking lack of urgency when it comes to warning consumers about safety issues.

Yes – even with an issue as important as cancer risk.

Humor not intended

The agency infighting concerns a popular class of blood pressure drugs. They’re called ARBs. They go by the brand names Cozaar, Diovan, Avapro, and others. Millions take these drugs every day. In fact, in the U.S. alone, patients shell out more than $7 billion for them every year.

In other words, ARBs are Big Business. And if you want to know what the FDA really is, it’s “the U.S. Drug-Business agency.”

Just look at this…

Results from several trials link ARB use to cancer, especially lung cancer. One researcher spells it out bluntly… “I have no doubt that ARBs increase cancer risk.”

A senior cancer specialist at the FDA wants to issue a warning. And that’s it. He’s not trying to ban the drug. He’s not calling for special panels. But he and others say the cancer evidence is solid and the risk is significant. So consumers deserve a warning.

And what are his bosses doing? They’re trying to shut down the effort. And put a kibosh on any warning.

Somehow, news of this office head-butting leaked out, along with some sniping e-mails.

In one e-mail, an official said that even if there were a 30 percent higher risk of cancer, “I doubt there would be much enthusiasm for basing a regulatory decision (labeling or otherwise).”

Huh! Imagine that! There doesn’t seem to be much “enthusiasm” for a cancer safety warning at the “drug-safety agency!” (You can bet Merck and other ABR makers spent a lot of money ensuring this lack of enthusiasm.)

If you have high blood pressure and you take one of these ARB drugs, that’s YOUR potential cancer risk they’re bickering over.

So consider this your official warning… because I’m pretty sure it’s the only one you’re going to get.

Sources:
“Dispute Flares Inside FDA Over Safety of Popular Blood-Pressure Drugs” Thomas M. Burton, The Wall St. Journal, 5/30/13, online.wsj.com

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