Cholesterol Skeptics and the Bad News about Statin Drugs
by Maryann Napoli
The cholesterol skeptics were there. So were
the physicians who challenge the safety and necessity of
cholesterol-lowering drugs. And then there were the lipid
researchers whose findings totally contradict the prevailing
dietary advice to the public: Avoid saturated fats, limit
cholesterol, and use more polyunsaturated oils. Their presentations
were met with enthusiastic approval at a conference held
last spring in Arlington, Virginia. But then again, the
attendees were not the usual people who show up at a conference
billed as "Heart Disease in the 21st Century: Beyond
the Lipid Hypothesis." They were practicing physicians,
biochemists, farmers, greenmarket activists, researchers,
cooks, parents of young children, and people who have been
told their cholesterol is too high. The general message
was: Fats are extremely important to good health...the right
kinds of fat, that is.
Cholesterol was the dominant topic of the two-day event,
as well as the subject of the opening lecture provocatively
entitled, "High Cholesterol Protects Against Disease."
Uffe Ravnskov, MD, PhD, a Danish physician who has published
many critical papers about the purported association between
cholesterol and cardiovascular disease, led off with a slide
showing the results of all the major clinical trials that
attempted to prove that lowering cholesterol in healthy
but high-risk people would reduce their death rate from
heart disease. "The reduced rates of cardiovascular
mortality were small for men and non-existent for women,"
said Dr. Ravnskov, who is the author of The Cholesterol
Myths, a paperback that refutes the theory that cholesterol
in our food and in our blood causes heart disease.
These cholesterol trials also looked at total mortality,
that is, the deaths from all causes, and found little difference
between the study participants who tried to lower their
cholesterol and those who did not. In other words, some
clinical trials showed that the heart disease death rates
were, in fact, lower among men who had reduced their cholesterol
levels. But this benefit was offset by a higher rate of
deaths from other causes.
Given these unimpressive research results, why is high cholesterol
so firmly imbedded in our consciousness as a sure-fire sign
of a future heart attack? Dr. Ravnskov said that it all
started with the landmark Framingham Heart Study, which
began following healthy people in the early 1950s to see
who had a heart attack and what distinguished them from
the people who did not. High cholesterol was one risk factor--but
it was only one of more than 240 others. "They [public
health officials, cardiologists, etc.] have confused a statistical
association with causation," he observed. "It's
as if they saw a house burning and determined that the bigger
the fire, the more fireman are present, and then concluded
that firemen cause burning houses."
When studies failed to prove that lowering cholesterol made
any lifesaving difference, researchers forged ahead with
more multi-million dollar clinical trials. Not until the
statin drugs (Lipitor, Mevacor, Zocor, Lescol, Crestor,
Advicor) came along did cholesterol-lowering finally prove
to be lifesaving to high-risk but healthy people. Whether
this benefit might actually be due to the anti-inflammatory
effects of statins has been the topic of controversy ever
As with several of the speakers who would follow him, Dr.
Ravnskov is unimpressed with the reduction in heart disease
mortality shown for the statin drugs "When you look
at the CARE trial [Cholesterol And Recurrent Events], Pravachol
did show a small benefit--after five years 5.7% had died
from heart disease in the [untreated] control group, compared
to only 4.6% in the treatment group, but [this benefit]
was not dose related." he said, referring to the expectation
that the more a person lowers his or her* cholesterol, the
less likely a heart-related death. Also, the people taking
Pravachol had a few more deaths from other causes. Dr. Ravnskov
managed to push the envelope further by making a case for
high cholesterol as a protective against cancer. He showed
slides listing published studies that found higher rates
of infectious disease among hospitalized people with low
cholesterol levels. Also, several studies found higher cancer
rates in people with low cholesterol levels.
Women told to take statin drugs should be aware of this
risk found in the CARE trial: There were 12 cases of breast
cancer in the women taking Pravachol, compared with only
one case in the untreated (control) group. Statin drug proponents
dismissed this worrisome finding as a fluke, said Dr. Ravnskov,
because the control group would be expected to have had
more than one case of breast cancer.
"Anyone who questions cholesterol usually finds his
funding cut off," said Paul Rosch, MD, who started
his talk with a reminder that half of all heart attacks
occur in people with normal cholesterol levels. "Stress
has more deleterious effects on the heart than cholesterol,"
said Dr. Rosch, who is a clinical professor of medicine
and psychiatry at New York Medical College and president
of the American Institute of Stress. He put a different
spin on the oft-quoted studies of immigrants with low rates
of heart disease that change for the worse years after they
emigrated to the U.S. The shift to a Western diet is usually
identified as the culprit, but Dr. Rosch suggests that the
stress of adapting to a new culture is harder on the heart.
For example, a study of Japanese male immigrants found a
lower rate of heart attack among those who consumed a Western
diet but retained a Japanese lifestyle, compared to those
who continued to eat only traditional Japanese foods but
lived a Western lifestyle.
Statin Drugs & Memory Loss
Duane Graveline, MD, MPH, a retired family doctor and former
NASA scientist/astronaut, recounted his own hair-raising
experience taking the popular statin drug Lipitor for only
six weeks. Soon after he went for a walk, Dr. Graveline
was found wandering, confused, and reluctant to enter his
own home because he didn't recognize it or remember his
wife's name. Six hours later--after being examined by a
neurologist and undergoing an MRI--he came to his senses.
Transient global amnesia (TGA) was diagnosed. Neither he
nor his physician suspected Lipitor, so Dr. Graveline was
restarted on one-half the previous dose. Again, at six weeks,
the TGA returned. This time, he regressed to his teen-age
years with no memory for his time in college, medical school,
or the recent past. "Many decades of my life were obliterated,"
he said. "The diagnosis was TGA: cause unknown."
To verify his growing suspicion that Lipitor might be the
cause, Dr. Graveline wrote to Joe and Teresa Graedon, the
husband and wife team that writes the syndicated column
called The People's Pharmacy, which specializes in warning
the public about drug side effects. The Graedons asked for
permission to print his letter in their column, and once
it appeared, hundreds of people wrote in to say they, too,
had experienced severe memory loss while on Lipitor. "Patients
are reluctant to report amnesia, or they attribute the symptoms
to old age or early Alzheimer's," explained Dr. Graveline.
"And doctors are reluctant to see that the drug they
prescribed was the cause." Still, the official word
on Lipitor is that memory loss is not a statin side effect.
"Thousands of cases of memory dysfunction have been
reported to the FDA's Medwatch program," he said, "but
after two years, the agency still hasn't acted. And most
practicing physicians are unaware of the problem."
Lipitor is not the only statin linked to this side effect,
observed Dr. Graveline.
A reporter pointed out to that FDA-required trials do not
report memory loss in people taking statins. An explanation
was offered by Joel M. Kauffman, PhD, research professor
of chemistry and biochemistry at the University of the Sciences
in Philadelphia. "In drug trials, the pharmaceutical
companies often divide similar adverse effects into six
or seven different categories to keep the scarier side effects
under 1%." To illustrate his point, Dr. Kauffman said
that amnesia could be divided into confusion, memory loss,
senility, and cognitive impairment. There is general acknowledgment,
however, that muscle pain, weakness, fatigue, peripheral
neuropathy, and rhabdomyolysis, a potentially fatal muscle
disease, are statin side effects, though they are thought
to be rare.
With a little distance from his harrowing TGA experience,
Dr. Graveline said that he began to question why he took
Lipitor in the first place. "I had come to think of
cholesterol as my personal enemy--my cholesterol levels
had climbed [over the years] despite a fat-restricted diet,
but no one mentions the proper function of cholesterol in
the body," he continued. "We doctors march to
the low-fat, low-cholesterol band." He soon learned
that cholesterol plays a critical role in the maintenance
and healthy functioning of cell activity in the body.
Several speakers expressed the opinion that the statin drugs'
ability to reduce cardiovascular mortality has nothing to
do with cholesterol reduction, but instead can be attributed
to their anti-inflammatory effects. (A viewpoint that has
been appearing in medical journals over the last few years.)
Furthermore, the physicians who addressed the conference
were united in their concern that the statin drugs deplete
the body of an important anti-oxidant with muscle wasting
and heart failure as a result. Peter Langsjoen, MD, of Tyler,
Texas, said that he left his invasive cardiology practice
at the University of Texas Health Center to specialize in
"congestive heart failure, primary and statin-induced
diastolic dysfunction and other diseases of the heart muscle."
For over 20 years, he has been using coenzyme Q10 to treat
a broad range of cardiovascular diseases. Q10, as he called
it, can be purchased over the counter as a dietary supplement
in health food stores and pharmacies.
Dr. Langsjoen said that the research on the importance of
Q10 ties in nicely with the underlying philosophy of this
conference because increased levels of this "vitaminlike"
substance can be found in traditional foods with high fat
content like organ meats, seafood, and red meat. "I
call Q10 vitaminlike because it has properties of a vitamin,"
explained Dr. Langsjoen, "but since we synthesize it,
as well as get it in our diet, it's not truly a vitamin."
All statin drugs decrease both the blood levels and cellular
concentrations of Q10, observed Dr. Langsjoen, the higher
the dose, the greater the decrease in Q10. "As we get
older, our Q10 levels fall, but we really don't know why--could
be the diet," he said. "People who make it to
90 tend to have high Q10 levels, though. Most of the Q10
research has been focused on heart failure, said Dr. Langsjoen
because the heart uses a huge amount of Q10. "It has
been pretty well documented from biopsies that the severity
of heart failure correlates with the people who have the
lowest levels of Q10."
What's more, there is a serious gap in information regarding
the role of statins in treating heart failure. "All
the major statin trials excluded patients with class III
and IV [advanced] heart failure, so we have no safety data
in these patients with heart failure, though statins are
prescribed to them with reckless abandon." Dr. Langsjoen
is not alone in this concern which was expressed over a
year ago by Australian physicians who asked, "Statins
and Chronic Heart Failure: do we need a large-scale outcome
trial?" in the Journal of the American College of Cardiology.
Most medications destined to cause an adverse effect will
do so early on, according to Dr. Langsjoen, who found this
not to be the case with statins. "You don't realize
you're in trouble until two or three years later, and it's
hard to relate it to a drug you started a few years ago.
Dietary Fats and Oils
The story of how statin drugs became a multi-billion-dollar
industry may have started with the identification of cholesterol
as the chief culprit in heart disease, but in time the public
learned that the low-fat diet would prevent heart attacks
in people without symptoms of heart disease--an idea that
the sponsors of this conference believe has produced numerous
health problems. Mary Enig, PhD, an expert in lipid chemistry,
spoke of the misinformation perpetuated upon the public
by the government-sponsored "pyramid diet," which
was introduced over 20 years ago and marked the beginning
of the promotion of the low-fat diet. Along with the "use
sparingly" advice, fats, oils, and sugar are at the
very tip of the Food Guide Pyramid symbol that appears on
Dr. Enig believes that the rise of obesity is related to
type of foods Americans have been encouraged to eat by the
U.S. Department of Agriculture, the food industry, and consumer
groups. "[People are eating] a diet high in grain and
inappropriate fats, instead of the natural animal fats,
such as lard, tallow, chicken fat, goose fat, and the natural
vegetable fats, such as olive, palm, and coconut oils, that
we used to have in our diets," and contrary to the
current "propaganda," she explained that these
fats and oils are essential components to a healthful diet.
These so-called good fats provide the major fuel for the
heart, kidneys, and skeletal muscles, said Dr. Enig, who
said the inappropriate fats are the highly processed polyunsaturated
fats, such as soybean, canola, and corn oils, which are
promoted [ironically] as heart protective.
"Before the advent of modern vegetable oils, mankind
consumed small accounts of fresh, undamaged polyunsaturated
fatty acids found naturally as a component of his food,"
according to Dr. Enig. "Consumption of polyunsaturated
fatty acids is much higher today because vegetable oils
are used widely as cooking oils and in salad dressings,
baked goods, and snack foods. Polyunsaturated oils should
never be heated--yet during the extraction process these
oils are subjected to very high temperatures that encourage
rancidity and the formation of many harmful breakdown products."
An example of the harmful breakdown product, she explained,
is something called trans fatty acids, which are now generally
recognized by mainstream medicine as harmful to the heart.
Dr. Enig said that trans fatty acids do not appear on the
nutrition labeling of food products, but they should. Trans
fatty acids are abundant in partially hydrogenated vegetable
oils, which are usually listed in the ingredients section
of the food label, and are found in only small amounts in
Dr. Enig is a leading spokesperson for the Weston A. Price
Foundation, which sponsored this conference. The foundation
is named for a dentist who, beginning in the 1930s, studied
the dentition of healthy isolated people untouched by Western
civilization. He found that they inevitably had great bone
structure and beautiful straight teeth.
Primitive diets were nutrient dense, with four times the
calcium and mineral and ten times the level of fat-soluble
vitamins, compared to the modern American diet. Dr. Price
continued to study these isolated people as Western foods
were introduced. The white flour, sugar, devitalized oils,
etc., gradually displaced the traditional foods, such as
organ meats, fish eggs, and butter from pasture-fed cows.
Changes in diet led to rampant tooth decay; narrowing of
the face that brought on a susceptibility to sinus infections;
narrowing of the pelvis that led to childbirth difficulties;
and behavioral problems. Sally Fallon, president of the
tax-exempt foundation, told the conference that its goal
is to disseminate the research of this "nutrition pioneer.
According to the information packet supplied to the conference
attendees, the Weston A. Price Foundation takes no food
For More Information:
-Lots of free information about the traditional foods championed
by the Weston A. Price Foundation can be found on its Web
Tapes of this and past conferences can be purchased via
this Web site. Those without Internet access can call (202)
333-HEAL to learn the cost of receiving printed material
from the Foundation.
-Visit the International Network of Cholesterol Skeptics
at www.thincs.org. Most of
the conference speakers belong to this Network. The 51 members
are listed along with their publications.
*A study of elderly French women living in a nursing home
showed that those with the highest cholesterol levels lived
the longest (The Lancet, 4/22/89). The death rate was more
than five times higher for women with very low cholesterol.
Several other studies have shown similar results. Ironically,
Dr. Ravnskov noted that in his practice it was usually the
elderly women who were most worried about their cholesterol
Maryann Napoli is the associate director of the Center for Medical Consumers in New York City.