Public’s Cholesterol Concern Feeds a Drugs-vs.-Diet Debate

The young woman seemed on the verge of panic as she caught up with Dr. William Taylor, a Harvard University cholesterol expert, after a recent speech he gave at the National Institutes of Health.

She worked at the National Cancer Institute, was a non-smoker in her 20s with no family history of heart disease, rode a bike frequently and ate only tofu.

But she was still obsessed with cholesterol. “She said she’d been screened at a health fair and they told her her cholesterol was 198.” Taylor recalled. She wasn’t mollified by Taylor’s insistence that the reading was safe, and normal.

She was instead curious about whether she could find a solution, or at least peace of mind, in a pill.

By all accounts, at least half of all Americans have cholesterol levels that are too high. That the American diet is too rich in fat is not in dispute. But there is mounting concern that the current national preoccupation with cholesterol may set off a premature rush to drugging in the name of cure.

To Taylor, the exchange with the woman in Bethesda, Md., illustrates what he characterized as “the destructive and negative effects” of the growing cholesterol mania. The phenomenon, he said, may be focusing on a possible quick fix as opposed to the less pleasurable task of changing one’s life style.

A study last year estimated that for many people with cholesterol levels elevated into the high-risk range, cholesterol reduction by itself adds on the average only about three weeks to total life span.

That was before the arrival on the drug market of the latest cholesterol-controller, lovastatin. Dr. Anthony Komaroff, who worked with Taylor on the study in question, estimated that the drug has doubled the life expectancy gain. Now, he said, it’s 40 days.

“Some people,” Komaroff said, “might regard that as a big deal and something they’d be willing to take a medicine for the rest of their lives to achieve.” Taylor and Komaroff are at Harvard Medical School and Boston’s Beth Israel Hospital.

The controversy over the appropriate role of drugs in controlling cholesterol levels attracted the attention earlier this year of the English medical journal Lancet, which urged caution in embracing drug therapy. “Although a low plasma cholesterol level may be a desirable objective,” it concluded, “it is by no means certain that drug therapy is a good way of achieving it.”

There are already seven prescription cholesterol-control drugs on the market. The newest, lovastatin (brand name: Mevacor), was prescribed for 350,000 people in its first nine months on the market after approval last year by the Food and Drug Administration, according to Merck Sharp & Dohme, its maker.

Nonprescription preparations sold at health food stores--ranging from fish oil capsules and high-fiber laxatives to the Vitamin-B derivative niacin--have attracted attention on their own, according to panelists at a recent American Medical Assn. cholesterol panel in New York. Merck partially sponsored the program, designed for journalists, as part of its national marketing program to call attention to cholesterol in general and its drug in particular.

Merck and its competitors have been careful to avoid the appearance of overpromoting their anti-cholesterol products, but at least one research expert contends that the industry’s strategy is to increase cholesterol concern in the hope that patients will press their doctors for prescriptions.

“On a national basis, I think a lot of Merck’s educational programs have been directed primarily at physician awareness of the whole cholesterol issue,” said Dr. Donald Hunninghake, an expert on cholesterol pharmacology at the University of Minnesota. “Obviously, (an intended) byproduct is (that) the more they become aware of (the cholesterol issue), the more likely they are to use drugs.”

“I think we do have concerns that drugs (will be) perceived as the magic bullet,” he added, “and that every effort (instead) should be implemented to achieve maximum effect from diet before drug therapy is considered.”

“We don’t think that we are overselling or overpromoting the drug,” responded Roy Walker, a Merck spokesman. The drug salesmen who call on physicians to promote Merck products, he said, “are instructed to rely on a fair balance in presenting information on the drug.”

To specialists like Dr. Scott Grundy, a cholesterol expert at the University of Texas Southwestern Medical Center in Dallas, the vast majority of people with high cholesterol levels can successfully control their problems just by eating differently.

“We do not want people to view drugs as a panacea or as a replacement for (changing the) diet,” added Dr. Antonio Gotto, another internationally known cholesterol authority at Baylor College of Medicine in Houston. “Only the most severe cases would require a drug and, even when a drug is needed, dietary (change) should be continued.”

According to norms endorsed by the government’s National Heart, Lung and Blood Institute, levels of up to 200 milligrams of cholesterol per .1 milliliters of blood are officially classified as “desirable.” From 200 to 239, a person has “borderline” cholesterol elevation; from 260 to 260, “moderate risk,” and beyond that, “high” risk.

The anti-cholesterol drug arsenal has grown considerably in the last five years, bringing the ability to achieve greater and more reliable control over cholesterol. In addition to lovastatin, gemfibrozil, marketed in the United States as Lopid, has shown promising ability to control cholesterol levels within the last year based on a trial in Finland. It is manufactured by Parke-Davis.

The field is rounded out by several older drugs, including colestipol (Colestin, the Upjohn Co.), cholestyramine (Questran, Bristol Laboratories), probucol (Lorelco, Merrell Dow Pharmaceuticals, Inc.), clorfibrate (Atromid, Ayerst Laboratories) and nicotinic acid (Lipo-Nicin, the Brown Pharmaceutical Co., Inc., and Nicobid and Nicolar, Rorer Group, Inc.) The preparations work differently but all induce the liver to reduce total cholesterol and the more dangerous of its two major subtypes, low-density lipoprotein (LDL). It contains most of the potentially harmful fatty materials that account for formation of cholesterol-induced fatty plaques in the coronary arteries.

LDL is generally perceived as a more certain indicator of significant cholesterol risk. If the LDL level is above 160 milligrams per deciliter of blood, the situation is automatically defined as high risk. If the LDL is from 130 to 159, the situation needs attention but the risk is not as great. Most drug treatments either don’t affect or elevate levels of high-density lipoprotein (HDL), the so-called “good cholesterol.”

Lovastatin has shown in laboratory studies that it can reduce total cholesterol by as much as 34% and LDL by as much as 42% while elevating the beneficial HDL by as much as 9%. Gemfibrozil lowered total cholesterol by as much as 8.6% and LDL by as much as 6.4% while raising HDL by as much as 24.6%. There is a risk of side-effects, including gastrointestinal distress, itching, flushing of the skin, rash, headaches and gallstones. Liver function can sometimes be impaired.

There have been some reports of increased incidence of cataract surgery in people taking the drugs, and a statistical association in some studies with an increase in cancer deaths and incidence.

For a small subgroup of the total population, drug control of cholesterol represents the only way to guarantee long-term survival. Such patients have a genetic defect called familial heterogeneous hypercholesterolemia, in which their livers’ ability to maintain safe cholesterol levels is impaired.

Drs. Michael Brown and Joseph Goldstein, University of Texas at Dallas researchers who won the 1985 Nobel Prize in medicine for their cholesterol research, told the AMA conference that drug treatment of people with heterogeneous hypercholesterolemia is now possible. Their pioneer research found that only one in 500 people may have this genetic defect.

“There is very persuasive evidence that these drugs do work,” Goldstein said. But life style control is even more important, he said, because a high-fat diet can figuratively “flip the switch in the liver” that permits cholesterol control.

By contrast to the small number of people with true genetic defects, more than 50% of Americans have high cholesterols simply because they don’t eat correctly, Goldstein and other experts said. Diet modification can lower cholesterol levels by an average 6% to 12%. Smoking cessation and blood pressure control are also essential, experts agree.

Taylor and a variety of experts at the AMA symposium agreed that only between 1% and 8% of all people with elevated cholesterol levels should resort to drug therapy to control the problem. The range is consistent with a wide variety of published studies.

In calculating the longevity gain that can be achieved by strict cholesterol control, Taylor and Komaroff found that in low-risk people between 20 and 60 years old, strict control may add between three days and three months to their life spans. For high-risk people, the longevity gain increased to between 18 days and 12 months.

“If you’ve eliminated smoking, the cholesterol seems to have less impact,” Taylor said. “So, to the extent that (with emphasis on drugs to control cholesterol and cholesterol-mania in a larger sense) we’ve redirected people’s attention away from other risk factors, we’ve done a disservice.

“There are clearly people who stand to make money from this. They’re fanning the flames, but they didn’t set the fire.”