Deaths Prompted Withdrawal of Cholesterol Drug Pfizer Inc. halts tests of a highly touted new cholesterol drug because of an unexpected number of deaths and other complications. Testing on the drug, torcetrapib, was ceased after more people in the drug group died than in the placebo group. The drug was unique in that it raises HDL, the "good" kind of cholesterol.

Deaths Prompted Withdrawal of Cholesterol Drug

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MELISSA BLOCK, host:

From NPR News, this is ALL THINGS CONSIDERED. I'm Melissa Block.

ROBERT SIEGEL, host:

And I'm Robert Siegel.

There are quite a few drugs that lower bad cholesterol but the medication that Pfizer abruptly pulled from a test study did something else. It raised good cholesterol. Pfizer and others had big hopes for the drug. The problem was it evidently caused an alarming number of deaths.

Coming up we'll talk with a doctor about what this news means for people working to lower their cholesterol. First, NPR's Joanne Silberner reports on what the demise of the new drug means for researchers hoping for a chemical fix for heart disease.

JOANNE SILBERNER: Heart researchers like Steven Nissen, head of the American College of Cardiology, had great hopes for torcetrapib.

Dr. STEVEN NISSEN (American College of Cardiology): The drug raised the good cholesterol, HDL, by at least 50 percent in most clinical trials.

SILBERNER: So manufacturer Pfizer has poured a lot of effort into testing the drugs and has since headed a multi-center trial to see if the drug could reduce cholesterol buildup in arteries. Over the weekend, the company got word about another trial that simply looked at whether the drug saved lives or cut back on illnesses. It involved 15,000 people. Half took torcetrapib and the statin drug Lipitor. The other half just took Lipitor. There were 51 deaths among those taking just Lipitor and 82 deaths in the group that also took torcetrapib. Again, Steven Nissen:

Dr. NISSEN: Either something else was causing harm or the cholesterol, the HDL levels that we were building up weren't protecting the patients.

SILBERNER: The company immediately stopped the trial and is studying the data to see what caused the extra deaths. They'll look especially hard at conditions related to hypertension since the drug is known to slightly elevate blood pressure.

Just last week the head of Pfizer said the company strongly believed in the drug, and heart experts like Barbara Howard were rooting for it. She's an expert on cholesterol and heads MedStar Research Institute, part of a consortium of nonprofit hospitals in the Washington area.

Dr. BARBARA HOWARD (President, MedStar Research Institute): Now that we have very good drugs that lower LDL like statin, that's not the whole picture in the control of heart disease through lipids. The other piece is the good cholesterol, HDL. A lot of people have low levels of it and we've never had good agents to raise it.

SILBERNER: She says there are lots of options yet to try and in fact, a Pfizer spokesman says the company has several similar drugs in the pipeline. They're trying to figure out now whether the problems with torcetrapib come from lowering HDL cholesterol, lowering a certain type of HDL cholesterol or from some unique characteristic of the torcetrapib molecule itself, something that may not be in other, similar molecules.

Today, the researchers involved in the torcetrapib trial are calling their patients and telling them to stop taking it, and the Food and Drug Administration has something new to worry about. Robert Meyer is with the FDA Center for Drug Evaluation and Research.

Dr. ROBERT MEYER (Center of Drug Evaluation and Research): This finding with Pfizer's drug is a definite signal that we need to be very vigilant about how this might inform the development of the other products. There's no reason to believe that they shouldn't be developed but we certainly will do so - and I'm sure the sponsors of those products will do so - with great caution as we proceed.

SILBERNER: Many heart researchers say the caution is worth it. Statin drugs alone haven't been enough to drop cardiovascular disease from its status as the number one killer in the U.S.

Joanne Silberner, NPR News.

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