Making Sense of the Cholesterol Controversy
                             by Dale Blumenthal 

Just as Americans all over the country were cutting out doughnuts as a
breakfast staple and ice cream as a routine nighttime snack, a journalist 
published a book that called the benefits of eating less fat a "myth." Next,
scientific studies endorsing the value of low blood cholesterol reported
that eating oat bran and olive oil may not be a panacea for those worried 
about heart disease. Suddenly, what had seemed a direct disease prevention
message became a complicated issue. The debate about cholesterol--whether to
lower it and how to lower it--was on. 

Killer Disease

Despite impressive declines in mortality rates over the past 20 years,
coronary heart disease remains the leading cause of death in the United 
States. It is the number one killer of both men and women, claiming more
than 500,000 American lives each year.

In 1985, the National Heart, Lung, and Blood Institute launched the National
Cholesterol Education Program (NCEP) to reduce death and disability from
heart disease by controlling high blood cholesterol. Blood cholesterol is a 
substance that travels through the body and deposits fatty streaks in the 
inner linings of the arteries.

"The evidence relating diet (including saturated fatty acids and dietary
cholesterol--a fat-like substance contained in animal foods)--to blood
cholesterol levels and coronary heart disease is compelling," NHLBI says, 
citing a variety of animal and human studies. 

In a pamphlet sent to doctors in November 1987, NCEP recommended that 
physicians advise patients to have their blood cholesterol checked every
five years (more often if it is found to be high) and to eat a healthful
diet, low in saturated fat and dietary cholesterol. (See "Do You Know Your
Cholesterol Level?" in the March 1989 FDA Consumer) 

However, journalist Thomas J. Moore, in his book Heart Failure, takes issue 
with the need for such a program. According to Moore, a series of government
heart disease studies have been an "extravaganza put on" by the "medical
elite." The relationship between diet and coronary heart disease is "tenuous
at best," says Moore. But, what he called "a medical version of the 
military-industrial complex" has eaten up an enormous amount of federal 
funds to convince the public that changing the diet will reduce heart 
disease.

Since 1948, NHLBI researchers have reviewed the cholesterol levels, living
habits, and diet of 5,127 adults in Framingham, Mass. During this study,
scientists have demonstrated a link between high blood cholesterol levels 
and increased heart disease. However, Moore maintains that the study has
failed to show a link between diets high in cholesterol and heart disease.

Yet, other studies have established a dietary connection, although smaller
than expected. In the seven-month-long Heart-Diet Pilot, conducted in 1968
by researchers from the University of Minnesota, participants who ate less
cholesterol and saturated fat and more polyunsaturated fat lowered their
blood cholesterol levels 10.5 percent.

Reinterpreting or Misinterpreting?

To bolster his arguments, Moore points to the 10-year Multiple Risk Factor
Intervention Trial conducted by NHLBI. Most of the 12,866 men in the study
smoked cigarettes, were obese, and ate a diet with more than twice the
recommended amount of cholesterol. They were divided into two groups. One 
entered an extensive fitness and diet program, and the other received no
special program. After seven years, researchers found no significant
difference in the number of deaths due to heart disease among the men. "The 
trial failed completely," Moore says. 

But, Timothy Johnson, M.D., medical editor of ABC News and the first editor 
of the Harvard Medical School Health Letter, sees the results from this 
trial differently. For instance, he writes in the Harvard Medical School
Health Letter, "telling the control subjects about their high-risk status 
and sending them back to their own physicians with that information led to
efforts to reduce their risk." The fact that the number of coronary deaths
was 40 percent less than expected in both groups leads Johnson to conclude
that "the reason the two groups didn't differ much was that the controls, 
like the subjects, changed."

Moore questions the credibility of other studies. In 1984, NHLBI selected 
nearly 4,000 middle-aged men with high blood cholesterol to participate in
the large-scale Coronary Primary Prevention Trial. All were placed on diets 
low in fat and cholesterol. Then, half the men were instructed to drink 
twice daily a mixture of water and cholestyramine, a drug expected to lower 
blood cholesterol. After seven years, the group treated with the drug showed
an 8 percent reduction in blood cholesterol. Another failure, according to
Moore. NHLBI anticipated a 28 percent reduction.

NHLBI, however, has another explanation. The drug had unpleasant side 
effects, including constipation, gas and heartburn. Many of the men were
unable to follow the prescribed regimen. The men who took the full dose of
the medication reduced their cholesterol by 25 percent and experienced
almost 50 percent fewer heart attacks and deaths from heart disease than the
placebo group. And, Moore fails to point out that the men who lowered their 
blood cholesterol the most suffered fewer heart attacks than those in the 
placebo group.

Filling in the Holes

"Science can't answer all the questions," says Susan Okie, M.D., a
Washington, D.C., physician and journalist. A skeptic can easily identify 
the holes and translate promising findings into negative ones.

"No scientific outcome is ever unanimous," the American Heart Association 
(AHA) explains. Nevertheless, AHA and NHLBI summarized the cholesterol
research in response to Moore to show that scientific evidence makes an 
undeniable case that intervention to lower blood cholesterol--by diet or, 
when necessary, by medication--reduces the risk of coronary heart disease.

Research results published since the September 1989 release of Moore's book 
continue to strengthen the argument for eating a diet low in saturated fats.
In a study described in the March 23 issue of the Journal of the American 
Medical Association, researchers from the Atherosclerosis Research Institute
at the University of Southern California School of Medicine were able for 
the first time to link the consumption of saturated fatty acids with the
growth of new coronary lesions. In a March 1 article in the New England 
Journal of Medicine, Columbia University researchers reported that healthy
college-aged men who ate a low-fat diet for 10 weeks lowered their blood
cholesterol levels by 8 percent. Based on available evidence, say experts 
such as Richard Peto of Oxford University, a 1 percent reduction in blood 
cholesterol level diminishes the risk for coronary heart disease by 
approximately 2 percent.

Healthy Eating for All

Because people with high blood cholesterol have a high rate of heart
disease, because a low-fat diet can reduce blood cholesterol levels, and
because "the magnitude of the problem posed by elevated blood cholesterol 
levels is very clear," NCEP on Feb. 27 recommended that all Americans over 2
reduce the saturated fat and cholesterol content of their diets.

FDA, along with a coalition of 38 federal agencies and health organizations,
endorsed the recommendation. F. Edward Scarbrough, Ph.D., acting director of
FDA's office of nutrition and food sciences, points out that disease may
develop from many years of eating a diet high in saturated fat and that 
dietary habits are established long before an individual is diagnosed with
coronary heart disease. "Eating a healthy diet makes good disease prevention
sense in general," says Scarbrough. 

Good disease prevention, according to the new NCEP recommendations, includes
a diet containing:
* less than 10 percent of total calories from saturated fatty acids 
* an average of 30 percent of total calories or less from all fat 
* total calories necessary to reach or maintain a desirable body weight 
* less than 300 milligrams of cholesterol per day.

According to the report, the major decrease in total fat should be in 
calories from saturated fatty acids. Saturated fat raises blood cholesterol 
more than anything else in the diet, even more than dietary cholesterol.
Saturated fats usually are solid at room temperature. They are present in 
largest amounts in animal products such as butter, cheese and meat. (Whole
milk, which has a relatively high saturated fat content--5.1 grams in 8 
ounces--is one exception to this general guideline.)

Survey data from USDA's Human Nutrition Information Service show that 
saturated fatty acids make up 13.2 percent of total calories in the average 
American's diet. If the new recommendations are followed, this would mean an
average reduction of slightly over 3 percent of saturated fat in the average
diet. 

Unsaturated fats (polyunsaturated and monounsaturated) are healthy
substitutes for saturated fat. Vegetable oils such as safflower, corn,
soybean, cottonseed, sesame, and sunflower oils are good sources of 
polyunsaturated fats. These fats should provide up to, but no more than, 10 
percent of total calories, according to the report. Monounsaturated 
fats--from oils such as olive, peanut and canola--should provide remaining
fat. According to the report, Americans should slightly increase their
intake of unsaturated fats. 

Cholesterol is found only in food from animal sources, such as egg yolks, 
dairy products, meat, poultry, shellfish, and--in smaller amounts--fish.
Also, organ meats--liver, for instance--are particularly rich in cholesterol. 

According to USDA survey data, the average daily intake of dietary
cholesterol is 304 milligrams for women and 435 milligrams for men. This
means most women should slightly reduce their cholesterol intake, while most
men should reduce it significantly (by 135 milligrams daily). 

Mixed Messages

Cholesterol is now a household word. In their weekly trips down supermarket 
aisles, grocery store shoppers can't escape messages about low cholesterol. 
Children come home with warnings about cholesterol from school health 
classes. Many runners and walkers and just about anyone who regularly lifts 
weights in a fitness center can recite their blood cholesterol level as 
automatically as their birth date.

Popularity of the "C" word has accompanied a growing interest in health,
along with concern about disease. So, new information about the possible
cholesterol-lowering benefits of some foods is an immediate 
attention-getter. The problem is that, just as understanding of the links 
between diet, high blood cholesterol, and coronary heart disease has evolved
slowly, so has our scientific understanding about the effects of different
nutrients on blood cholesterol levels progressed slowly.

Oat bran became an immediate hit in the late 1980s as scientific studies, 
such as a 1986 project from Northwestern University, seemed to show this
soluble fiber could lower blood cholesterol levels. Dietary fiber became an 
issue, as researchers questioned how oat bran affects blood cholesterol 
levels. While some scientists believed that it might directly affect blood
cholesterol levels, others speculated that the chief effect of oat-bran 
consumption is simply that people substitute it for high-fat foods. 

The stage was set for a research study from Boston's Brigham and Women's
Hospital and the Harvard Medical School that found high-fiber (like oat 
bran) and low-fiber diets had the same cholesterol-lowering effect. Along 
with the amount of fiber they ate, participants reduced their consumption of
foods high in fat and dietary cholesterol. Researchers concluded that oat 
bran consumption does not directly affect blood cholesterol levels. However,
when people eat more oat bran, they often reduce their intake of other foods
high in saturated fat--thus producing the cholesterol-lowering effect.

When this study was published in the Jan. 23, 1990, issue of the New England
Journal of Medicine, it made front-page news and precipitated stock market
speculations about the fall of oat bran, the miracle cure-all.

Olive oil, high in monounsaturated fat, shared the same fate. Results from a
study of 4,903 Italian men and women showing that olive oil consumption was 
associated with lower blood cholesterol levels were published in the Feb. 2 
issue of the Journal of the American Medical Association. Other recent
research also has suggested that monounsaturated fats may be good for your
heart.

The March 1 issue of the New England Journal of Medicine, however, reported 
findings from a Columbia University study concluding that monounsaturated 
fats are no more beneficial than poly-
unsaturated fats. The newspapers that day carried headlines such as "Olive
Oil's Benefits Don't Pan Out."

Similarly confusing messages have resulted from recent research on other
products as well. New studies seem to suggest that while caffeine may 
trigger heart rhythm abnormalities, drinking decaffeinated coffee may raise 
blood cholesterol levels. And, while egg yolks contain large amounts of 
dietary cholesterol, recent USDA data, based on new testing methods, show 
that the cholesterol content of the average large egg is lower than 
previously thought. According to the latest measurements, a large egg 
contains 213 milligrams of cholesterol per egg, not the 274 milligrams
reported in earlier published data. 

What to Do? 

These mixed messages nevertheless continue to point to the same healthy 
advice: Eat a diet low in fats, especially saturated fats. Don't throw away 
your oat bran, but don't rely on it solely either. Get your nutrients from a
variety of foods. You don't have to throw out your eggs either--but eat egg 
yolks in moderation.

No one food will magically lower your blood cholesterol level. But the
low-fat diet recommended by NCEP will hurt no one and was designed to help
most Americans. 

Dale Blumenthal is a staff writer for FDA Consumer.