CHOLESTEROL SKEPTICS AND THE BAD NEWS ABOUT STATIN DRUGS

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http://www.medicalconsumers.org/pages/cholesterol_skeptics.html

 

CHOLESTEROL SKEPTICS AND THE BAD NEWS ABOUT STATIN DRUGS

 

 

By Maryann Napoli

(June 2003)

 

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

since.

 

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.

 

Coenzyme Q10

 

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 food labels.

 

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 animal fats.

 

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 industry funding.

 

For More Information:

 

-Lots of free information about the traditional foods championed by the Weston

A. Price Foundation can be found on its Web site (www.westonaprice.org). 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 levels.

 

 

Maryann Napoli is the associate director of the Center for Medical Consumers in

New York City.

 

 

 

 

 

 

 

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© 2001 Center for Medical Consumers

 

 

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