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Experts Worry That Side-Effect Fear Could Set Back Battle Over Cholesterol

By RON WINSLOW
Staff Reporter of THE WALL STREET JOURNAL
 

Heart experts are concerned that the recent recall of the cholesterol-lowering drug Baycol may undermine one of the most intensive campaigns ever mounted against heart disease, the Western world's leading killer.

Across the country, heart patients are jamming phone lines to doctors' offices in response to the recall, which resulted from a finding that linked Baycol to more than 31 deaths from a rare muscle-wasting condition called rhabdomyolysis. Many of the callers were taking the drug, but many others are on one of five other similar medicines, all belonging to a class of potent cholesterol-reducers known as statins.

The Baycol recall "has definitely caused a lot of my referring physicians and a lot of patients who are on statins to ask, 'Are you sure this isn't going to be a problem with the other statins?' " says Jeffrey Werner, executive director of the Seattle Cardiovascular Research Group.

Statins, which are marketed by such drug giants as Merck & Co., Bristol-Myers Squibb Co. and Pfizer Inc., are among the most studied and most promoted drugs ever. Their ability to reduce deaths, heart attacks and other major health events has transformed treatment of cardiovascular disease. Indeed, no heart expert would doubt that statins have saved thousands of lives and prevented thousands of heart attacks in contrast to the handful of deaths that have been linked to their use.

"We have a class of medicines that is extraordinarily beneficial," says Neal Shadoff, a cardiologist at Presbyterian Heart Group in Albuquerque, N.M., which has logged more than 700 calls from patients since Bayer AG withdrew Baycol from the market on Aug. 8. "However, as with any medicine, they require surveillance. Nothing is without side effects."

In May, the National Cholesterol Education Program issued new guidelines urging more aggressive treatment of people with high cholesterol -- especially those with so-called LDL cholesterol over 130. While healthy diet and exercise programs remain an important strategy in cholesterol reduction, treatment with statins is a cornerstone of the new guidelines, which suggest that some 36 million Americans should be on the drugs -- about triple the number under the previous criteria.

Aside from childhood vaccination programs, no public health effort calls for more intense use or reliance on a single class of medicines. Many experts believe that statins rank with the success of antismoking efforts as the two most significant factors in reducing the toll from cardiovascular disease in the past decade. So a spotlight on a potentially fatal side effect could have important consequences beyond the recall of one drug. "There is a lot at stake here," says Dr. Shadoff.

On Monday, Public Citizen, an advocacy group, urged the Food and Drug Administration to strengthen warnings on the remaining cholesterol-lowering drugs, saying that it had documented evidence that all five of them were associated with some cases of rhabdomyolysis, though comparatively much fewer than for those taking the Bayer drug. Sidney Wolfe, director of Public Citizen Health Research Group, called for a so-called black box warning, the agency's strongest, on the label governing use of the drug.

Doctors who have handled inquiries from patients during the past two weeks say that in addition to switching Baycol patients to other statins, they are counseling those taking the other drugs not to worry.

"The vast majority of people who have been on these drugs for years and years -- that's millions of patients -- have done extremely well," says Paul Ridker, a cardiologist at Boston's Brigham and Women's Hospital and Harvard Medical School. "I've been spending a fair amount of time reassuring patients who are on them" to stay on them.

The telltale signs of the culprit side effect are muscle aches and pains not associated with rigorous physical activity. Doctors say generally that any patients on a statin who experience such pain should stop taking their drug and call their doctor.

The new attention to the problem also calls on both patients and doctors to be more vigilant about getting regular blood tests to check not only for signs of the muscle problem but for elevated liver enzymes that could be a sign of liver inflammation.

Both the muscle and liver side effects, though potentially serious if left unchecked, are nearly always reversible if caught early and the use of the medication is stopped, doctors say. Moreover, oftentimes, after a brief period off the drug, patients can try again with a different statin without experiencing any side effects.

Marc Pfeffer, professor of medicine at Harvard Medical School, says a recent analysis of three major studies involving Bristol-Myers' Pravachol didn't turn up any differences of muscle or liver side effects for those taking the drug compared with those who were taking a placebo. The analysis covered the equivalent of 112,000 patients taking the drug for a year. Rare events happen, says Dr. Pfeffer, also a cardiologist at Brigham and Women's Hospital, and "you can never have too much safety." But "these are very safe drugs."

Michael Lauer, director of clinical cardiology research at the Cleveland Clinic, has been prescribing statins for his patients since the late 1980s, when they first reached the market, and says he hasn't seen a case of rhabdomyolysis. Indeed, he has encountered relatively few cases where a patient had to stop taking the drugs because of muscle or liver irregularities.

Doctors have known about the potentially serious muscle problems since shortly after statins came on the market, but they were preoccupied with other worries: cataracts, birth defects and cancer. The drug isn't recommended for pregnant women. The cataract problem, which showed up in some early animal studies, never materialized, says Donald Black, a former Warner Lambert executive who helped develop Lipitor, now marketed by Pfizer. Large-scale studies haven't turned up any increased incidence of cancer among those who take the drugs.

"The thing people were least worried about was rhabdomyolysis," says Dr. Black, now in clinical practice in Cincinnati. "The number of people who developed inflamed muscle tissue during studies of the drug was under one-tenth of one percent, and rhabdomyolysis is about one one-hundredth of that. It's quite rare."

Write to Ron Winslow at ron.winslow@wsj.com⁴

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