The risks of quick drug approval

Pharmacy technician Gloria Oates fills out a prescription of Levoxyl at Rosemont Pharmacy January 18, 2006 in Portland, Maine.

Kai Ryssdal: In what's becoming a distressingly familiar story, yet another expensive brand name drug has been found to be no more effective than the older, cheaper ones.

The drug in question this time is Nesiritide -- it's for heart problems. The government spends billions of dollars on medications every year that may well be ineffective. And as Gregory Warner reports from the Health Desk at WHYY, Washington hasn't done a very good job of finding out what those medicines are.


Gregory Warner: When you have a heart attack, Nesiritide helps you breathe. The drug was approved in 2001 and made billions of dollars for Johnson & Johnson. This week, a study published in the New England Journal of Medicine finds that the drug -- at $500 per dose -- works no better than conventional treatments that cost pennies.

Eric Topol: And it shouldn't take 10 years for us to learn the truth about a drug.

Dr. Eric Topol is an executive at Scripps Health, the not-for-profit health system in California. He blames drug companies and the FDA.

Topol: Because today, the FDA doesn't have the teeth and the authority to tell a company: unless you do this definitive trial now, we're going to pull this drug's approval.

Joel Hay: I don't think we can expect the pharmaceutical industry to be on the hook for all of that cost.

Joel Hay is a health economist at USC. He says evaluating a drug's effectiveness is expensive and needs government funding. But he says some government panels set up to study effectiveness have been sandbagged by politics. So the health care reform law sets up a nonprofit independent board with a $200 million budget to study which drugs and which treatments are effective. Gene Washington is the executive director.

Gene Washington: It's not just Drug A v. Drug B. It's what happens to me; is it better for me to come in to see the doctor for this treatment or should I be seeing a different kind of provider?

The board could publish answers to these questions by 2014, if the board is still around. There's a bill in Congress to have the board repealed.

In Philadelphia, I'm Gregory Warner for Marketplace.

About the author

Gregory Warner is a senior reporter covering the economics and business of healthcare for the entire Marketplace portfolio.

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