Do Cholesterol Drugs Do Any Good?

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The whole statin story is a classic case of good drugs pushed too far, argues Dr. Howard Brody, professor of family medicine at the University of Texas Medical Branch at Galveston. The drug business is, after all, a business. Companies are supposed to boost sales and returns to shareholders. The problem they face, though, is that many drugs are most effective in relatively small subgroups of sufferers. With statins, these are the patients who already have heart disease. But that's not a blockbuster market. So companies have every incentive to market their drugs as being essential for wider groups of people, for whom the benefits are, by definition, smaller. "What the shrewd marketing people at Pfizer and the other companies did was spin it to make everyone with high cholesterol think they really need to reduce it," says Dr. Bryan A. Liang, director of the Institute of Health Law Studies at the California Western School of Law and co-director of the San Diego Center for Patient Safety. "It was pseudo-science, never telling you the bottom-line truth, [which is] that the drugs don't help unless you have pre-existing cardiovascular disease." The marketing worked, Liang says, "even in the face of studies and people screaming and yelling, myself included, that it is not based on evidence."

Pfizer replies that the industry is "highly regulated" and that every message in ads and marketing "accurately reflects Lipitor's labeling and the data from the clinical trials."

Drugmakers, however, do make sure that the researchers and doctors who extol the benefits of medications are well compensated. "It's almost impossible to find someone who believes strongly in statins who does not get a lot of money from industry," says Dr. Rodney A. Hayward, professor of internal medicine at the University of Michigan Medical School. The NCEP's 2004 guideline update garnered headlines by recommending lower targets for bad cholesterol, which would put more Americans on the drugs. But there was also a heated controversy in the medical community over the fact that 8 of the 9 experts on the panel had financial ties to industry. "The guideline process went awry," says Michigan State's Barry. He and 34 other experts sent a petition of protest to the National Institutes of Health, saying the evidence was weak and the panel members were biased by their ties to companies.

EASY METRICS

The appearance of conflict of interest is "very important to organizations like ours, and we are all taking it seriously," responds NIH official and NCEP coordinator Dr. James I. Cleeman. "But the facts of the science were entirely correct."

Yet Cleeman's confidence is not universally shared. To statin critics, Americans have come to rely too much on easy-to-grasp health markers. People like to have a metric, such as cholesterol levels, that can be monitored and altered. "Once you tell people a number, they will be fixated on the number and try to get it better," says University of Texas' Brody. Moreover, "the American cultural norm is that doing something makes us feel better than just watching and waiting," says Barry. That applies to doctors as well. They are being pushed by the national guidelines, by patients' own requests, and by pay-for- performance rules that reward physicians for checking and reducing cholesterol. "I bought into it," Brody says. Not to do so is almost impossible, he adds. "If a physician suggested not checking a cholesterol level, many patients would stomp out of the office claiming the guy was a quack."

Yet Brody changed his mind. "I now see it as myth that everyone should have their cholesterol checked," he says. "In hindsight it was obvious. Duh! Why didn't I see it before?"

Cholesterol is just one of the risk factors for coronary disease. Dr. Ronald M. Krauss, director of atherosclerosis research at the Oakland Research Institute, explains that higher LDL levels do help set the stage for heart disease by contributing to the buildup of plaque in arteries. But something else has to happen before people get heart disease. "When you look at patients with heart disease, their cholesterol levels are not that [much] higher than those without heart disease," he says. Compare countries, for example. Spaniards have LDL levels similar to Americans', but less than half the rate of heart disease. The Swiss have even higher cholesterol levels, but their rates of heart disease are also lower. Australian aborigines have low cholesterol but high rates of heart disease.

Moreover, says MSU's Barry, cholesterol-lowering medications other than statins "do not prevent heart attacks or strokes." Take Zetia, which blocks absorption of cholesterol from the intestines. Marketed by Merck and Schering-Plough, the drug brought in $1.5 billion in 2006, with sales climbing 25% in the first half of 2007, says IMS Health (RX). The companies combined it with a statin to create a drug called Vytorin, with over $2 billion in sales in 2007.