Rushing drugs to market is dangerous. Blaming the rush on you and me is ludicrous.

Back burner safety

I wonder what member of “the public” told the FDA to put safety on the back burner and rush drugs to market.

I didn’t tell them. Did you? I didn’t think so.

But according to FDA officials, WE asked for it. They’re actually blaming you and me for the risky drugs Big Pharma slides through the approval process.

And here’s the worst part. You or someone you care about might easily find yourself on the losing end of a scam just like this…

Blame the victim

It’s an FDA tale of madness. And it’s all too common.

In 2000, the agency approved Mylotarg to treat a rare blood cancer. According to the hype, the drug could potentially increase survival by a few months. So the agency gave Mylotarg accelerated approval.

Of course, a follow up safety study was required. But the study revealed no benefits AND a sharply increased risk of death. Pfizer immediately took the drug off the market.

Just one catch. Mylotarg was on the market for 10 years before the study was completed. For a DECADE, it was hyped as hope. But it was pure despair.

Well — not despair for everyone. In 10 years, Mylotarg produced millions in sales.

And that’s just fine with the FDA.

Recently, FDA officials told The Wall St. Journal that they’re under pressure to approve new drugs ASAP. To hear them tell it, they’re just giving us what we’ve asked for.

Riiiight. Here’s the fantasy according to Janet Woodcock. She’s the FDA director of the Center for Drug Evaluation and Review. She tells WSJ that “medical groups” and the “public” have urged the FDA to move faster and be LESS cautious.

According to her, that’s what “we” want.

First of all, “medical groups” is code for drug companies. And drug company lobbyists. And Congressmen who owe favors. And medical organizations that depend on drug company donations.

But this business about the general public is just ludicrous. I’ve never heard of an Average Joe pressuring the FDA to dismiss safety in order to get new drugs on the shelves in a hurry.

When Woodcock talks about “the public,” I think she’s referring to desperate patients who pin their hopes on drugs hyped as potential lifesavers. But I’m sure she’s aware that there’s only the slimmest chance that ANY lives will be saved when the agency pushes drugs to market quickly.

That’s how you end up with Mylotargs — useless drugs that increase risks and drain savings accounts.

I would call that a lose-lose situation. But look at drug company bottom lines. It’s clear that somebody is winning. And they’re winning big.

Sources:
“The Safety Risks of Innovation:  The FDA’s Expedited Drug Development Pathway” Journal of the American Medical Association, Vol. 308, No. 9, 9/5/12, jama.jamanetwork.com

“Article Says Agency Let Risky Drugs Hit Market” Thomas M. Burton, The Wall St. Journal, 9/4/12, online.wsj.com