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I found this by accident this morning:

2 S.D. scientists raise questions about cholesterol-cutting drugs

By Susan Duerksen

May 28, 2001

Defying a near-universal medical consensus, two San Diego scientists are among the few researchers questioning whether the side effects of immensely popular cholesterol-lowering drugs have been adequately investigated.

One scientist is testing whether the drugs, known as statins, affect thinking and mood -- for better or worse -- and the other has preliminary results suggesting that muscle damage may be more common than previously reported.

The researchers readily agree that statins prevent heart disease and extend the lives of many people, but they said the relatively subtle risks have been neglected by drug-company-sponsored studies and may take on greater importance as healthier people begin using the drugs.

New federal guidelines announced this month lowered the target level of blood cholesterol, recommending statin use for many more people who have no other heart disease risk factors. The experts who wrote the guidelines estimated the number of Americans taking statins should nearly triple, from 13 million to 36 million.

"There is no question that these drugs are miracle drugs. They save millions of lives every year," said Dr. Paul Phillips, a cardiologist at Scripps Mercy Hospital. "What irks me is, it's important to know all sides of the equation, and nobody's paying attention to the toxic side of the equation."

Phillips has completed the first stage of a small study showing that some patients taking the drugs have muscle pain and strength loss that is not detectable by the one muscle test used in all the major statin studies. He has not published the results.

Dr. Beatrice Golomb, a cardiovascular epidemiologist at UCSD, is enrolling patients in a much larger study to determine whether lowering cholesterol with statins affects the brain, mood or personality.

A year ago, a Pittsburgh study showed small decreases in attention and reaction speed among people taking statins.

On the other hand, two other recent studies suggest that the drugs may protect against the dementia of Alzheimer's disease. Both found that people who had taken statins were less likely to develop Alzheimer's disease later.

Golomb and the Pittsburgh researcher said those findings may not be reliable. The studies were based on reviews of medical records, with no way to measure differences between patients that might have influenced the outcome.

With a $4.2 million grant from the National Institutes of Health, Golomb has started a more definitive study, giving a statin or a dummy drug to each of 1,000 people with similar health risks for six months and testing their thinking and memory before and after.

Goal of drugs
Statins are prescribed to reduce levels of cholesterol, fats that circulate in the blood and can contribute to clogged arteries.
"Statins are wonderful drugs in terms of protecting against heart disease," Golomb said. "But you don't want to look just at what it does to one organ, even one as important as the heart. You really want to know how it affects the whole person."

She is particularly concerned that the overall effect on women is not yet known. While statins have been shown to reduce heart disease and heart attacks for both genders, there is no evidence that the drugs lower overall death rates for women, as they do for men.

Unless that is proved through further study, Golomb said, it's possible that other detrimental effects counteract the heart benefits for women.

Dr. Yale Mitchel, executive director of clinical research for Merck, which makes two of the major statins, agreed that the drugs have not been shown to increase women's overall survival.

He said that's because it has been hard to get enough women into the studies, although a new study including 5,000 women is expected to be finished in November.

Many doctors and researchers say they already know plenty about statins, which have been on the U.S. market for about 15 years.

"Millions of people have taken the statin drugs," said Dr. Larry Favrot, a San Diego cardiologist. "The safety of these drugs is almost unsurpassed, and the knowledge we have about these drugs is remarkable."

Dr. Anthony Demaria, chief of cardiology at UCSD School of Medicine, said it is possible some long-term or subtle side effects haven't been discovered. However, he said the safety of statins has been tested so thoroughly that many cardiologists take the drugs themselves.

"The epidemic of heart disease is the No. 1 killer in this society," he said. "It's undeniable that people who take drugs that lower their cholesterol almost invariably do much better."

$13 billion in sales
The six major statins -- Lipitor, Zocor, Pravachol, Baycol, Lescol and Mevacor -- had sales totaling almost $13 billion last year, according to industry analysts. Lipitor is the top-selling pharmaceutical in the world. (The chemical names all end similarly: atorvastatin, simvastatin and so on.)
The drugs interfere with a protein that makes cholesterol, and they also help to stabilize plaques formed by cholesterol inside arteries. The benefits last only as long as the drugs are taken; people who have too much cholesterol in their blood usually must take the drugs for life.

There are two recognized side effects. About one in 100 patients on statins develops problems with liver function. Doctors monitor for that and stop use of the drugs when it happens. Also, some patients have muscle damage indicated by leakage of a particular muscle enzyme into the blood.

Phillips said his placebo-comparison study, with 40 patients so far, has shown that muscles can be damaged and weakened without leaking the enzyme. It may take six to eight years for the problem to build up, he said, and studies of statin safety have not lasted that long.

Dr. Jerrold Glassman, Mercy's medical director of cardiology and a colleague of Phillips, said many patients on statins may have side effects that doctors don't take the time to evaluate seriously.

"A lot of patients complain of being weak and fatigued," he said. "We tend to discount unfairly many of the complaints elderly people have. Managed-care wants us to give them the drug and let it be."

Phillips said about half of his patients with muscle pain also seem to have some thinking problems while taking the drugs.

It is not clear how statins could cause either type of problem -- whether the potential harm lies in the lower cholesterol itself or is an unrelated effect of the drug.

Cholesterol issues
Dr. Matthew Muldoon conducted a University of Pittsburgh study last year that linked statin use to small but significant cognitive deficits. He said he believes the problems may stem from manipulating a person's natural cholesterol level, and wouldn't show up in a person with naturally low cholesterol.
Golomb said it is possible that, for some people, higher cholesterol levels -- while risky for the arteries -- could be good for the brain.

Cholesterol, the bad guy of heart disease, is also a nutrient needed by every cell in the body. It is particularly abundant in the membranes of brain cells.

Cholesterol levels may affect levels of serotonin, a brain chemical known to be related to depression and aggression, Golomb said. In her study, she is measuring participants' serotonin levels as well as testing their memory and thinking abilities.

Dr. Benjamin Wolozin, of Loyola University Medical Center near Chicago, conducted one of the two studies finding lower rates of Alzheimer's disease among statin users. He agreed that "people with very low cholesterol seem to be more prone to cognitive decline when they get very old."

Yet, if cholesterol does help protect older brains from general decline, it also is known to contribute to the buildup of amyloid protein, a major factor in Alzheimer's disease, Wolozin said. He said his findings and Muldoon's are not contradictory.

Mitchel, at Merck, said further exploration of side effects could be dangerous because it may discourage some patients from taking life-saving drugs. He said the questions have been put to rest through numerous studies involving almost 30,000 patients.

Merck did two small studies a decade ago specifically looking for effects on brain function, and found none, Mitchel said. In larger statin studies, all patient complaints were compiled, he said, and muscle pain was just as common among patients who didn't know they were taking a dummy drug as those on the statins.

"The anxiety about the side effects is exaggerated, to say the least," said Dr. Daniel Steinberg, an endocrinologist and co-director of UCSD's Lipid Research Clinic. "These drugs are safer than aspirin. There have been scads of studies that are carefully controlled, and any effects are noted."

Golomb, whose parents are both taking statins, said she will be "the first person to be overjoyed" if she finds the drugs have only beneficial effects.

"I deeply believe it's important that somebody take an honest look at it . . . that isn't being funded by the pharmaceutical industry," she said.

(Courtesy of the San Diego Union-Tribune)

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