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FDA plans look inside medical records

Nancy Marshall-Genzer May 23, 2008

FDA plans look inside medical records

Nancy Marshall-Genzer May 23, 2008


KAI RYSSDAL: The Food and Drug Administration’s trying something new. It wants to make extra sure the drugs and medical devices on the market really ought to be there. So to sniff out possible safety problems the FDA’s going to start mining millions of medical records. Not yours…but maybe the ones your hospital has. Marketplace’s Nancy Marshall Genzer has more.

NANCY MARSHALL GENZER: Everybody thinks the initiative is a great idea. But this is a common refrain:

BRUCE PSATY: It will take a lot of work.

Doctor Bruce Psaty teaches medicine at the University of Washington.

PSATY: This not going to be something where you can go the computer and in two minutes say this drug is associated with this, and we need to act on it.

The FDA starts pilot projects using Medicare data in a month. But the initiative, called Sentinel, will be rolled out over many months.

There’ll be challenges. How to convince hospitals to start using the same terms. Some write out defibrillator, while others just write defib. That confuses computers. Some hospitals still use paper records. And, how do you pinpoint that a drug or medical device really caused a common heart attack? And when do you warn consumers?

George Washington University epidemiologist David Michaels says drug companies won’t want a rush to judgment.

DAVID MICHAELS: Because they don’t want to scare patients from taking these particular drugs. On the other hand, consumer advocates say, “We want to know as quickly as possible if there’s some potential problem out there.”

The FDA had been relying on doctors to report patients’ side-effects. It was a slow process. The consumer groups complained that it allowed dangerous drugs to stay on the market too long. FDA scientist Rachel Behrman says that won’t be a problem with the Sentinel Initiative.

RACHEL BEHRMAN: Sentinel will provide us with a very quick tool — method — to push information out.

How much that information push will cost is unknown.

In Washington, I’m Nancy Marshall Genzer for Marketplace.

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