The FDA puts patients at risk when drugs are rushed to market without full safety reviews

Blame the victim.

It’s a classic defense in a courtroom, but now officials at the FDA seem to be employing the “they asked for it strategy.” And blaming US for the risky drugs they put on the market.

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…

Someone is winning

In 2000, the FDA 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.

Finally, 10 years later (10 years!), Mylotarg was abruptly taken off the market. The study revealed no benefits AND a sharply increased risk of death.

It was hyped as hope. But it was pure despair.

Well, it wasn’t despair for everyone. In 10 years on the market, Mylotarg made millions in sales.

I thought of Mylotarg when I read about a new paper in the Journal of the American Medical Association. Two drug-safety experts make the case that the FDA approved drugs with “significant safety questions unanswered.”

Yep. That’s our FDA!

One of the three drugs featured (just picking one at random here) is supposed to help prevent multiple sclerosis relapse. Officials approved the drug, even though it had “seven major safety issues.” In exchange for the quick OK, the FDA required 10 post-marketing studies.

Um…10? Really? Makes you wonder. What kind of elaborate safety concerns would require 10 different studies? And yet, they want to flood the bodies of MS victims with this drug while they are finding out?!

In response to the JAMA paper, FDA officials assured 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 plain laughable. I’ve never heard of an Average Joe pressuring the FDA to be less cautious about safety in order to get new drugs on the shelves in a hurry.

When Ms. Woodcock talks about “the public,” I think she’s referring to desperate patients who pin their hopes on drugs that have been hyped as potential lifesavers. But I’m sure she’s aware that there’s only the slimmest chance that ANY lives will ever 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.

“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,

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

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