Doctors' 'Treat the Numbers' Approach Challenged It can take scientists a decade or more to determine whether a drug actually works. In the meantime, doctors rely on other measures, like testing blood pressure and cholesterol levels, to determine whether a drug is having positive effects. But recent studies challenge the practice of prescribing medicine based on certain test results.

Doctors' 'Treat the Numbers' Approach Challenged

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And next we'll look at an issue that affects practically every doctor and patient. It's the practice of prescribing medicine based on tests for cholesterol - blood sugar or thousands of other things that doctors can order. Sounds like a good idea, but recent studies show how misleading that can be.

NPR's Richard Knox reports.

RICHARD KNOX: Doctors call it treating the numbers, trying to get a patient's test results to a certain target. They assume that will treat or prevent disease. But earlier this year a study on a widely used cholesterol drug challenged that assumption. The drug is called Vytorin. It's a combination of two cholesterol lowering agents. It certainly lowers cholesterol, but patients taking it didn't have any less plaque in a major artery than those taking a less potent drug.

When the results came out, Dr. Steve Atlas of Massachusetts General Hospital began getting calls from his patients and his mom.

Dr. STEVE ATLAS (Massachusetts General Hospital): For my first patient it was like let's make a visit and schedule an appointment. For my mother it became a longer discussion.

KNOX: She's not so easy to put off, right?

Dr. ATLAS: Exactly.

KNOX: Ellen Atlas is a tennis-playing 75-year-old who's been taking Zetia, one of the cholesterol-lowering ingredients in Vytorin, because regular statin drugs cause muscle pain, a common side-effect. Zetia reduced her cholesterol very nicely. But now she wanted to know if it was doing her any good.

Dr. ATLAS: For my mom, it was like, wow, I'm treating the number and I'm not going to necessarily prevent the stroke that her mother had. And all of a sudden it was like I don't want to take this medicine.

KNOX: Steve Atlas was brought up short by the surprising cholesterol results.

Dr. ATLAS: It's a big deal, because it reminds us of something that we often forget - the number isn't the outcome. And this raises concerns that just lowering the number doesn't get you where you want to be.

KNOX: Dr. Ned Calonge chairs a national task force that assesses what works and what doesn't in preventive medicine. He still believes that cholesterol lowering drugs reduce heart disease, but he says the recent study challenges the goal of getting Americans' cholesterol lower and lower.

Dr. NED CALONGE (United States Preventive Services Task Force): Now what's open is, is lower better? And I think a lot of people believed it would be and there were many of us that were saying you're going to need to show me.

KNOX: And lately studies have challenged other cherished assumptions, like lowering blood sugar. For a long time doctors have believed that getting diabetic patients blood sugar as close to normal as possible would prevent heart attacks. A drug called Avandia lowers blood sugar very well.

Dr. CLIFF ROSEN (FDA): Avandia was approved in 1999 and heralded as one of the newer and greater drugs for the treatment of diabetes.

KNOX: That's Dr. Cliff Rosen. He chairs a Food and Drug Administration advisory panel, which unanimously concluded last year that patients taking Avandia actually had more heart attacks and strokes.

Rosen says the Avandia story is a caution against treating millions of patients on unproven assumptions. Normalizing blood sugar probably does prevent heart disease for patients with Type 1 diabetes, but it's unproven for the far more common Type 2.

Dr. ROSEN: It's not clear yet, even now, even after all these years, that in Type 2 diabetes keeping your blood sugar at a certain point will prevent heart disease.

KNOX: In fact, last month a federal study showed that a big group of Type 2 diabetics who got aggressive treatment to lower blood sugar actually had more death than those on standard therapy.

The treating the numbers problem also comes up in decisions to use common tests. One is bone density scans for osteoporosis. Rosen, a bone disease specialist, often tries to talk patients out of getting the $400 scans to check on whether their drugs are working.

Dr. ROSEN: These are good drugs. They work in osteoporosis. But they work not just because they change bone density. That's the bottom-line. And you know what? I've been zero percent successful. I have never yet talked an individual out of a bone density follow-up measurement.

KNOX: On the other hand, Steve Atlas, the Boston internist, says many of his patients are choosing not to take cholesterol lowering drugs as a result of the recent study. But he's uncomfortable letting his own mother's elevated cholesterol go untreated.

(Soundbite of phone ringing)

Ms. ELLEN ATLAS (Mother): Hello?

Dr. ATLAS: Hi, mom. It's Steve.

Ms. ATLAS: Hi.

Dr. ATLAS: How are you doing this morning?

Ms. ATLAS: Just great. Thank you.

KNOX: Ellen Atlas has stopped taking Zetia. She's improved her diet and increased her exercise. But her son is skeptical that'll be enough.

Dr. ATLAS: I obviously hope that your numbers are better with just the lifestyle changes that you've been making, because I think that would be great. But if they're still a little bit high, then starting sort of like a baby dose, a really low dose of...

Ms. ATLAS: Of what - which one? Do you think that I should go back to one of the statins?

KNOX: Mother and son hope a low dose of a tried and true statin will get her close to the right cholesterol number without the side effects she suffered before.

Richard Knox, NPR News, Boston.

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