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From The Boston Globe

New pills ward off many ills

By Richard Saltus, Globe Staff, 12/30/2000

Since he began popping a daily Lipitor pill only two months ago, Luay Awqatti has seen his cholesterol plunge 100 points and his chest pains fade.

Even better, his doctor says Awqatti is cutting his risk of having a heart attack or dying from one because he's taking Lipitor, one of a group of drugs called "statins" that are revolutionizing the treatment and prevention of heart disease.

"I'm flabbergasted" at the improvements, said Awqatti, 58, a project engineer for the state health department.

Doctors themselves are swallowing statins at a rapid clip - and not just to protect their hearts, but also their brains, bones and to ward off cancer. Though very preliminary, recent studies encouragingly suggest that statins may lower the risk of Alzheimer's disease, osteoporosis, and even colon cancer.

"I typically ask a group of cardiologists how many are taking a statin, and about 75 percent hold up their hands," said Dr. Antonio Gotto, a prominent cardiologist and statin proponent who is dean of Weill Medical College of Cornell University.

But the very success of the statins is raising a tough ethical question for the medical profession: Why isn't everybody taking them?

"Most people who could substantially benefit from statins are not getting them," said Dr. Stephen B. Hulley of the University of California in San Francisco, citing recent reports of surveys done in the past few years.

"A surprisingly low percentage of people who have had a heart attack or bypass surgery or angioplasty" are on statins, "and the great majority of them - who are at a high 10-year risk - should be getting them."

Even when doctors prescribe statins for such patients, they often don't give enough, said Dr. Stephanie Kafonek, a research official at Pfizer Inc., maker of Lipitor. "There is undertreatment and undermanagement" of patients, she said.

In fairness, doctors have become increasingly free in prescribing statins, especially after studies suggesting that the drugs are probably safer than aspirin. Today, an estimated 13.6 million Americans are on the drugs, and statins make up 6 percent of all drug prescriptions in the United States.

"We've become more and more aggressive" in prescribing statins, said Dr. Stanley Lewis, associate chief for clinical cardiology at Beth Israel Deaconess Medical Center. "There used to be much more concern about the potential side effects." Liver and muscle complications can occur very infrequently, researchers say.

Others want to go much further in making statins readily available. Two drug companies have proposed putting low-dose statin drugs on pharmacy shelves, making them available without a prescription. So far, the Food and Drug Administration has given a thumbs-down, but officials say they're not opposed to the concept.

However, even as the move to increase statin distribution gains steam, some medical professionals are worrying about the staggering cost of prescribing the pills to the more than 80 million Americans who meet current guidelines for needing to lower their cholesterol levels. These are people with known heart disease or several heart risk factors, and who have high LDL or "bad" cholesterol.

Dr. Joe Gerstein, medical director of pharmacy services at Tufts Health Plan, says that a month's supply of statins costs about $100. If statins were prescribed for every American with elevated cholesterol, to say nothing of people at risk for Alzheimer's disease or osteoporosis, it would cost about $100 billion a year. That's equal to the bill for all prescription drugs Americans take annually, he said.

"It's fair to say this is a problem of national scope," said Gerstein. "It's staggering." So far, the Tufts plan hasn't moved to set limits on use of the statin drugs, and their use continues to surge, Gerstein said.

On the other hand, some suggest that statins may have so many health benefits that the long term savings to society far outweigh the cost of the pills. Beyond heart disease, recent studies of large groups of patients suggest that those who took statins were less at risk for the fragile bone problem, osteoporosis, that often occurs in older people. One report said the statin-takers had 50 percent fewer bone fractures.

And, last fall, researchers at the University of Massachusetts Medical School in Worcester, along with scientists at Boston University School of Medicine, reported that in a large group of elderly patients, those who took statins had a 70 percent lower risk of developing Alzheimer's, the disabling and lethal disease that destroys memory.

Yet another unanticipated benefit of the statins, Cannon said, is that they subdue inflammation, which may explain part of their benefit in preventing coronary heart disease.

It's a remarkable success story for a family of drugs discovered by Japanese researchers in mold in 1976. What statins do in the body, researchers found, is block an enzyme called HMG CoA reductase that helps the liver process cholesterol. In response, the liver pulls cholesterol out of the bloodstream for its own uses, so that less of it ends up clogging blood vessels.

The first statin to the marketplace was lovastatin, or Mevacor, and a total of six have been approved for sale. Their brand names, in addition to Mevacor, are Zocor, Pravachol, Lescol, Baycol, and Lipitor.

Cholesterol, a fatty substance that is needed by the body but can also be hazardous, is not only made by the liver but taken in through our diet. Cholesterol may be helpful or harmful depending on its action. Doctors worry about elevated total cholesterol and too-high levels of LDL cholesterol, the "bad" kind that's transported by low-density lipoproteins in the body.

The drugs went on the market before anyone knew how much they would help patients with different degrees of heart disease risk. Since 1994, a string of reports has shown that statins slash the risk of heart attacks, strokes, and deaths among different groups of patients. Those at high risk, because they've already had a heart attack or bypass surgery or angioplasty, benefit the most.

In theory, statins could be given to young people to help prevent heart disease. But in young or low-risk patients, the astronomical cost is hard to justify. By one estimate, said Hulley at the University of California in San Francisco, starting statin treatment for life in people in their 30s could cost as much as $1.4 million per year of life extended.

Statin manufacturers have, not surprisingly, moved quickly to explore uses for statins beyond lowering cholesterol, which could make their large market even huger. But, says Yale Mitchel, a senior research director at Merck & Co., which makes Mevacor, "we're not really convinced yet" of these apparent statin virtues.

This story ran on page A01 of the Boston Globe on 12/30/2000.
© Copyright 2000 Globe Newspaper Company.

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