The Cholesterol Paradigm: The Greatest Health Scam of the Century; Beware of the Side Effects of Anti-Cholesterol Drugs
The Cholesterol Paradigm: The Greatest Health Scam of the Century
An Interview with Sheldon Zerden, Part 1Many people are still being taught by those with vested interests that eating cholesterol will cause heart disease. Some people may be shocked to learn that there are more than a dozen better indicators of artery and heart disease risk than blood cholesterol levels. I have often referred to the “Cholesterol Myth” and “Cholesterolphobia” in this column. As Dr. Stephen Sinatra has pointed out in this column many times, “the broken record of cholesterol keeps playing in the Dark Age of medicine.” It’s time to point out the facts, and fortunately, a new book by Sheldon Zerden does just that—point out the facts. The Cholesterol Paradigm: The Greatest Health Scam of the Century by Sheldon Zerden is scheduled for publication in December 2009 by Benelos LLC. However, a lot of people don’t want to be confused by the facts when it is so obvious that food cholesterol results in arterial deposits of cholesterol—or at least they think so. We will examine the facts in the next two columns.
By Richard A. Passwater, Ph.D.
Readers may remember two chats we have had with Sheldon Zerden reviewing health books. He has written, among others, The Best of Health: The 100 Best Health Books (WholeFoods in 2004) and The Cholesterol Hoax (discussed in WholeFoods in 1997).
Passwater: The discredited hypothesis that eating cholesterol increases the risk of heart disease was based on imperfect circumstantial evidence. As I challenged on the cover of my 1977 book, Supernutrition For Healthy Hearts, “If anyone can step forward and prove that eating cholesterol causes heart disease, I will donate all of the proceeds from my book to the American Heart Association (AHA).”
Needless to say, no one has offered such proof, but the challenge did get me an opportunity to explain the real evidence on media ranging from Good Morning America to major newspapers and television shows around the world. The media took interest in the challenge and tried to find cholesterol proponents to prove the case. They couldn’t be found. More importantly, the challenge earned me frequent guest spots on the radio shows of Dr. Robert Atkins and Carlton Fredericks, which resulted in life-long friendships.
People found it hard to accept the truth after they had been essentially brainwashed for decades into thinking that eating cholesterol caused heart attacks. It seemed so obvious—eat cholesterol and it will automatically zap directly onto your arteries. Your new book, The Cholesterol Paradigm: The Greatest Health Scam of the Century, really brings the evidence to light.
Why did you write the book?
Zerden: I wrote the book as a follow-up effort to The Cholesterol Hoax. I did research on The Cholesterol Paradigm for three years and we edited the manuscript for several more years, while adding new studies and material to make it as up-to-date as possible. It has a great deal of material that can help the reader understand the whole history of the invalidated cholesterol theory. We have to counteract the overwhelming effects of the media and drug companies.
I wanted the public to know the truth about the dangers of low blood cholesterol levels and how dangerous the anti-cholesterol drugs are. People should know that they risk malnutrition when they give up nutritious foods and eat low-cholesterol and low-fat diets thinking they will reduce their risk of heart disease. I wanted to give the scientific evidence proving that the Cholesterol Diet–Heart Hypothesis is totally invalid and that they would only divert their efforts from the real causes of heart disease if they were to follow the guidelines widely promoted by vested interests. Not only would they waste their time and money on anti-cholesterol drugs, but they would also risk their health and lives from their deadly side effects.
Passwater: The decades old “obvious” relationship between dietary cholesterol, plasma cholesterol and atherosclerosis was built on three lines of imperfect circumstantial evidence: animal feeding studies, epidemiological surveys and clinical trials. Over the past quarter century, studies investigating the relationship between dietary cholesterol and atherosclerosis have debunked the idea that dietary cholesterol increases heart disease risk and the validity of dietary cholesterol restrictions based on these lines of evidence. As Dr. Donald McNamara points out, “Animal feeding studies have shown that for most species, large doses of cholesterol are necessary to induce hypercholesterolemia and atherosclerosis, while for other species even small cholesterol intakes induce hypercholesterolemia. The species-to-species variability in the plasma cholesterol response to dietary cholesterol, and the distinctly different plasma lipoprotein profiles of most animal models make extrapolation of the data from animal feeding studies to human health extremely complicated and difficult to interpret” (1).
Early laboratory animal studies with rodents could not induce atherosclerosis in rodents, so investigators switched to vegetarian rabbits. Since vegetables do not contain cholesterol, rabbits do not handle dietary cholesterol well and thus it is not surprising that in the laboratory, atherosclerosis-like plaque can be artificially induced in rabbits. Dr. McNamara also notes that “Epidemiological surveys often report positive relationships between cholesterol intakes and cardiovascular disease based on simple regression analyses; however, when multiple regression analyses account for the colinearity of dietary cholesterol and saturated fat calories, there is a null relationship between dietary cholesterol and coronary heart disease morbidity and mortality. Analysis of the available epidemiological and clinical data indicates that for the general population, dietary cholesterol makes no significant contribution to atherosclerosis and risk of cardiovascular disease” (1).
So, the great cholesterol myth got its start with the Seven Countries Study that attempted to associate diet with coronary heart disease incidence. However, a critical review of the Seven Countries Study by statisticians Drs. R.L. Smith and E.R. Pinckney revealed “a massive set of inconsistencies and contradictions,” leading to the conclusion that the “study cannot be taken seriously by the objective and critical scientist” (2). As one example, the mortality rate in Finland was almost seven times higher than in Mexico, although the fat consumption was identical. The so-called “French Paradox” is another example. The examples selected were chosen to fit their theory, rather than looking at all the available data.
Zerden: Science recognizes no manifestos; it aspires to the truth. Propaganda, on the other hand, is half-truth and often wishful thinking. There is no scientific or conclusive experimental proof that lowering serum cholesterol in humans results in prevention of atherosclerotic disease or heart attacks (3).
“The diet-heart propaganda was escalated by the American Heart Association (AHA). Soon, dietary dogma became a moneymaker for segments of the food industry, a fundraiser for the AHA and busywork for thousands of fat (lipid) chemists. To be a dissenter was to become unfunded because the peer-review system rewards conformity and excludes criticism” (4).
It is useful to review four lines of evidence:
1. One thousand persons in the Framingham Study were examined with a dietary review. There was no relationship between dietary habits and high blood cholesterol (cholesterolemia).
2. Two thousand persons in the Tecumseh Study were given 24-hour diet recall interviews. Levels of serum (blood) lipids (cholesterol, triglycerides, etc.) were found unrelated to dietary practice.
3. The Finnish Trial based on 29,217 person-years with subjects 34 to 64 years of age showed no effect of the treatment diet on total mortality. No diet therapy has been shown effective for the prevention or treatment of coronary heart disease.
4. Clinical trials with drugs used to reduce high blood cholesterol (cholesterolemia). There is no safe and efficacious drug known for the management of high blood cholesterol (cholesterolemia) (3).
Passwater: Does high blood cholesterol cause heart attacks?
Zerden: No, 80% of the people who have heart attacks have a cholesterol level below 222 mg/dL (5).
Passwater: Does age have an effect on cholesterol as the cause of heart attacks?
Zerden: Forty years of study at Framingham showed “no increased mortality with either high or low cholesterol levels among men after age 47.” The same is true for women regarding cholesterol and total mortality after age 47 or under the age of 40 (4).
Passwater: Dr. Kilmer McCully of homocysteine fame more than agrees. “In spite of the great emphasis on cholesterol levels, the Framingham study made several critical observations that refute the Cholesterol Diet–Heart Hypothesis. In the first place, dietary cholesterol has no relation to cholesterol levels in the blood, and dietary cholesterol has no relation to the risk of developing cardiovascular disease.
“This observation was confirmed by multiple large studies from Chicago, Puerto Rico, Honolulu, Netherlands, Ireland and the massive Lipid Research Clinics study of U.S. citizens. The next astounding finding is that elevated cholesterol is not a risk factor for women of any age or for men over age 47.
“Furthermore, both total mortality and cardiovascular mortality in Framingham participants increases in those with LOW cholesterol levels. This finding has been confirmed by multiple studies from Canada, Sweden, Russia and New Zealand. These contradictory findings have been ignored, distorted and incorrectly reported by supporters of the Cholesterol Diet-Heart Hypothesis (6).
How much cholesterol do people have in their blood?
Zerden: In a typical person, the entire body contains about five ounces of cholesterol. Only about 7% (one-third of an ounce) circulates in the blood (7).
Passwater: Do statin drugs cause cancer?
Zerden: Drs. Thomas Newman and Stephen Hulley from San Francisco published the results of a meticulous review of what we currently know about cancer and cholesterol-lowering drugs. They found that clofibrate, gemfibrozil and all other statins stimulate cancer growth in rodents (8).
Passwater: What are the side effects of low blood cholesterol?
Zerden: Thirty-one studies, including the Framingham Study, Seven-Countries Study and the giant MRFIT Study, reported higher cancer and/or total death rates with subjects who have lower blood cholesterol levels (9).
Passwater: It seems for years that the dieticians’ rule number one to stay in good health has been to avoid eating eggs. “Eggs are okay—just don’t eat the yolks” is often heard. Also, “egg white is just as good of a source of nutrition as egg yolk.”
Egg whites are a rich source of amino acids, but not so much for the micronutrients. I have often felt that the increased incidence of age-related macular degeneration is largely due to the stress on avoiding egg yolk for these last few decades. The macula needs lutein and zeaxanthin, which help give the yellow color to egg yolks.
Zerden: Most health professionals are well aware of the high nutrient density of eggs and the broad range of vitamins and minerals egg contains. What they seem to forget is that the majority of these essential nutrients are concentrated in the yolk (see Table 1). So for good nutrition, it is unwise to throw away these yolks.
Passwater: However, even many nutritionists today mistakenly think that eating cholesterol increases the amount of cholesterol in the blood.
Zerden: Three independent studies have shown that two eggs a day in the diet had no significant effect on blood cholesterol value of normal humans subjects (11–13). Two studies by Dr. Henry Ginsberg and colleagues at Columbia University College of Physicians and Surgeons found that young men and women who ate as many as three to four eggs a day for weeks on end had virtually no change in their blood cholesterol levels.
Passwater: The common “wisdom” claims that the epidemic of coronary heart disease during the first 60 years of the 1900s was caused by increasingly high blood cholesterol levels.
Zerden: This is not true. Please see Figure 1. The fact is that from 1900 to 1965, the cholesterol level of Americans was constant at 220 mg/dL (14).
Passwater: But, people who watch those television drug commercials may be convinced that the Cholesterol Diet–Heart Disease clinical trials have proved conclusively that a high-saturated fat, high-cholesterol diet causes coronary heart disease.
Zerden: There have been 33 clinical trials of the Cholesterol Diet–Heart Disease hypothesis in the last 30 years. The evidence clearly shows this is not a sound hypothesis. We cling to this disproved theory because of “pride, profit and prejudice” (15). How can these people admit they have made such a dreadful error? How can the AHA admit its error? Its fundraising program would self-destruct! How can bureaucrats admit they have wasted hundreds of millions of research money? These people are entangled in a web of deception.
Passwater: Dr. George Mann of Vanderbilt University in Nashville has pointed out many flaws in the cholesterol theory of heart disease. He stated in People magazine on January 22, 1979, “A ‘Heart Mafia’ is misinforming the American public. When we find the real cause and prevention of the cholesterol problem, it will seem to many that there was an unwholesome conspiracy.”
I notice he states the following about your new book: “The Cholesterol Paradigm reveals the biggest medical scam of the century—maybe the biggest scam of all time. It has mushroomed into a trillion dollar business which has compromised the lives of almost everyone.”
How about the role of genetics?
Zerden: If genetics is a primary cause of coronary heart disease, why was there such a great increase in deaths from coronary heart disease between the mid-1920s and 1968? Did our genes change in a matter of a few decades? Please refer to Dr. Christopher Mudd on this subject in Cholesterol and Your Health: The Great American Rip-Off (16).
Passwater: Proper vegetarian diets can be beneficial for general health, especially if they supplement their diets with zinc, CoQ10 and vitamin B12, which do not exist in vegetables. Vegetarians also tend to eat less junk food, follow healthy life styles and not smoke tobacco. Vegetarians have significantly lower blood cholesterol levels than non-vegetarians. Do vegetarians have lower mortality rates than non-vegetarians?
Zerden: No. They have lower blood HDL cholesterol. HDL cholesterol is the cholesterol carried in the blood by a protein-lipid carrier called high-density lipoprotein (HDL). Blood HDL levels are important to heart and artery health. The higher the HDL, the better. Female vegetarians have higher coronary heart disease mortality than female non-vegetarians. Male vegetarians have lower coronary heart disease mortality than male non-vegetarians, but they have higher all-cause mortality. Table 2 compares the rates.
Passwater: As Dr. Al Sears points out, “Dr. C.V. Felton and colleagues have shown that the plaque in arteries that causes heart disease is mostly made of unsaturated fats, especially polyunsaturated ones (in vegetable oil), not the saturated fat of animals like vegetarians believe (18). In fact, the body needs saturated fats to be able to use other key nutrients, like fatty-acids and fat-soluble vitamins.”
Any blood cholesterol reading of 200 mg/dL or higher is considered dangerous. Is there a direct association between blood cholesterol levels and the coronary heart disease death rate?
Zerden: The Framingham Study has found virtually identical death rates for subjects of either sex across a range of blood cholesterol levels from 205 to 265 mg/dL. Please see Table 3.
Passwater: Did the Multiple Risk Factor Intervention Trial (MRFIT) demonstrate a strong relationship between high blood cholesterol levels and the coronary heart disease death rate?
Zerden: No! In the largest trial (362,000 men screened to select 12,000 overweight, hypertensive smokers with high blood cholesterol), the MRFIT Study proved that across the entire range of blood cholesterol levels (150 to 350 mg/dL), the coronary heart disease death rate increased only 0.13%. This trivial difference in deaths makes the blood cholesterol numbers meaningless!
Passwater: The seven-year MRFIT Study should have stopped the dietary cholesterol nonsense, but it didn’t. The men were given a low-fat diet, smoking cessation, exercise and anti-hypertensive drugs. At the end of the trial, blood pressure was down, smoking decreased and average cholesterol levels were down 7%. When the results of this $100-million trial were analyzed, 115 in the treatment group had died of heart disease, compared with 124 in the control group. This is an insignificant difference. Looking at mortality from all causes, there were 265 deaths in the treatment group, compared with 260 in the control group. The investigators found minor benefits from smoking cessation, no benefit from lowering blood pressure, and no effect of lowering cholesterol levels by 2% compared with the control group.
Yet, the MRFIT Study is used as the basis of the widely repeated myth that “a one percent reduction in blood cholesterol level produces a two percent reduction in heart attacks.”
Zerden: The MRFIT study screened 362,000 men to find subjects with cholesterols above 265. The study failed even with the dishonest statistical analysis. Please look again at the Seltzer findings from the 30-year Framingham Study in Table 3 (19).
Passwater: In November 1985, the National Heart, Lung and Blood Institute (NHLBI) inaugurated the National Cholesterol Education Program (NCEP), which comprised of many scientists who receive funds from vested interests. If you go to the NCEP Web site, the group unequivocally states, “240 mg/dL and above is ‘High’ blood cholesterol. A person with this level has more than twice the risk of heart disease compared to someone whose cholesterol is below 200 mg/dL.”
Zerden: This is certainly refuted by other studies such as the Seltzer Study that formed the basis for Table 3. Dr. Seltzer in his study of 30 years in Framingham showed no difference in mortality with cholesterol of 205 up to 265 (19). The AHA and the NHLBI are so powerful that Dr. Seltzer had to publish this study in an Italian journal of cardiology. The European medical profession was not so smitten by the Cholesterol Diet–Heart nonsense.
Passwater: It seems that every couple of years, the NCEP lowers the target number for acceptable cholesterol levels as the preceding level was found not to be meaningful. This also has the effect of putting more and more people onto statin anti-cholesterol drugs each time to meet the lowered guidelines, yet the death rate doesn’t fall in clinical studies designed to test this theory. The “Third Report of the NCEP Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults,” also known as Adult Treatment Panel (ATP) III, appears in the May 16, 2001, issue of the Journal of the American Medical Association. These guidelines substantially expanded the number of Americans being treated for high cholesterol, including raising the number on dietary treatment from about 52 million to about 65 million and increasing the number prescribed a cholesterol-lowering drug from about 13 million to about 36 million.
Zerden: They find that their previous goals were ineffective, so the long-time proponents try yet another attempt with even lower numbers as goals. Other members of the group do it to sell statins. Most of the principles of these groups are on the payroll of the pharmaceutical companies.
Passwater: Death rates for coronary disease and stroke have dropped about 30% since 1999 according to Heart Disease and Stroke Statistics—2009 Update by the American Heart Association. They correlate this to total cholesterol levels having declined for women 60 and older and men over 39. They state that total cholesterol levels for these older Americans declined from 204 mg/dL to 199 mg/dL.
Zerden: The 5-mg/dl reduction is so trivial that it is pointless to give credence to this update.
Passwater: Yes, we have more than a 10% daily fasting variation just with the time of day.
The Cholesterol Myth was recognized by many cardiologists from the start, but vested interests, money and repetition eventually have their effects. Did the famous heart surgeon, Dr. Michael Debakey buy into the Cholesterol Myth?
Zerden: Absolutely not! He not only ate bacon and eggs everyday, but he was quoted in the Washington Star on June 15, 1972, “Much to the chagrin of my colleagues who believe this polyunsaturated oil and cholesterol business, we have put our patients on no anti-cholesterol medications. About 80% of my 1,700 patients with severe atherosclerosis requiring surgery have cholesterol levels of normal people.” Dr. Debakey died recently at 99 years of age.
Passwater: Is a high blood cholesterol level a strong risk factor for dying young?
Zerden: Absolutely not! In fact, Dr. Bernard Forette and a team of French researchers from Paris found that old women with very high blood cholesterol levels live the longest. The death rate was more than five times higher for women who had very low cholesterol. (20).
Passwater: Exercisers believe that vigorous and even punishing exercise leads to better health and longer life. They feel that cardiovascular health is promoted by vigorous and strenuous exercise and protects against heart attacks, the leading cause of death. Is exercise truly a way to prolong life?
Zerden: The sober truth should be stated. You may enjoy exercise, it may help you socially, you may look and feel better, but all the rest is myth. Exercise will not make you healthy. Exercise will make you fit. Fitness and health are not the same thing.
Fitness is measured physiologically by oxygen consumption. This doesn’t mean a thing to your heart. Running conditions the muscles and improves oxygen uptake and utilization, but does little for the health of the lungs. If cardiovascular health were a product of physical training, then fit people wouldn’t die of heart disease. Exercise may improve longevity up to a point, but exercisers suffer the same ills that plague us all. The leading cause of exercise-related deaths in well-trained people is coronary heart disease. You can be fit and healthy. You can also be physically fit and ill with coronary heart disease. Finally, you can be unfit and unhealthy as well. Please refer to the book, The Exercise Myth by Henry A. Solomon, M.D.
Passwater: On October 18 of this year, three marathoners died of heart attacks near the 12-mile marker within 16 minutes of each other during the Detroit Marathon. A study by Dr. Siegel and colleagues found several following risks for marathon runners (see Table 4).
Also, Dr. Al Sears, author of PACE: Rediscover Your Native Fitness, explains the heart hazards of vigorous exercises such as marathons. “This happens because adding repeated ‘cardio’ to our busy days and pushing for greater endurance produces the opposite result of what we need in the modern world. Routinely forcing your body to perform the same continuous cardiovascular challenge, by repeating the same movement, at the same rate, thousands of times over, without variation, without rest, is unnatural.
“Long-distance running shrinks your lungs and downsizes your heart’s output. Nature designed your body to adapt to whatever environment it encounters. If you ask it to run long distances repeatedly and routinely, it will adapt to meet the challenge more effectively.
When you run long distances like in a marathon you’re actually training your heart to get weaker.
“Your body downsizes your heart and lungs to enable a long-distance run. A smaller output will take you long distances more efficiently in the same way an economy car with a small engine gets you better gas mileage.”
Was the epidemic of coronary heart disease caused by Americans increasing their consumption of animal fats and cholesterol?
Zerden: Absolutely not! During the so-called epidemic from 1920 through 1969, animal fat consumption decreased. Animal fat consumption declined from 25 pounds per capita. Vegetable fats (polyunsaturated oils) increased from 10 pounds per capita to 50.4 pounds per capita; that’s a 500% increase. Please see Figure 2, which shows the consumption of animal and vegetable fats.
Passwater: Well, that’s a lot of upsetting news for many people. They are spending their time and money addressing a strategy of low-cholesterol, low-fat diets that in themselves have been proven scientifically not to reduce the death rate. Moreover, millions are taking statin drugs, which also have been shown to reduce blood cholesterol levels, but have not been shown to reduce the death rate as a result of any cholesterol-lowering actions. Yet, they have dangerous side effects on mental cognition, muscle function and energy.There are healthier diets of moderation and low-inflammatory diets that are more effective. Let’s pause here. We will look into statins, cholesterol and more science of the Cholesterol Diet–Heart Hypothesis next month. WF
References: The complete references for parts one and two of this article will be published in January 2010 with the second half of the column.
Published in WholeFoods Magazine, Dec. 2009. Reprinted with permission.
The Cholesterol Paradigm: Beware of the Side Effects of Anti-Cholesterol Drugs
An Interview with Sheldon Zerden, Part 2, by Richard A. Passwater, Ph.D.
Last month, we chatted with Sheldon Zerden about his new book, The Cholesterol Paradigm: The Greatest Health Scam of the Century. We discussed many of the fallacies of the Cholesterol Diet–Heart Hypothesis including four lines of evidence; any one of which is sufficient to disprove the cholesterol theory.
? One thousand persons in the Framingham Study were examined with a dietary review. There was no relation between dietary habits and high blood cholesterol (cholesterolemia).
? Two thousand persons in the Tecumseh Study were given 24-hour diet recall interviews. Levels of serum (blood) lipids (cholesterol, triglycerides, etc.) were found unrelated to dietary practice.
? The Finnish Trial based on 29,217 person-years with subjects 34 to 64 years of age showed no effect of the treatment diet on total mortality.
? In clinical trials with drugs used to reduce high blood cholesterol (cholesterolemia), no drugs for the management of high blood cholesterol (cholesterolemia) were proven completely safe and efficacious.
This month, we will chat about the hazards of the statin family of anti-cholesterol drugs.
As frequent guest in this column, cardiologist Dr. Stephen Sinatra remarked in his newsletter, “Though you wouldn’t know it was based on today’s obsession with cholesterol levels, cardiology has been slowly veering away from the narrow view of cholesterol as a primary cause of heart disease. Cardiologists are slowly accepting that it’s inflammation of arterial tissue that leads to heart disease and most strokes. The field is realizing that although cholesterol plays a role in the biochemical process that creates damage in arterial walls—which, in turn, leads to plaque, occlusions and clots—it’s a relatively minor one. In other words, they’ve realized that even though they may find cholesterol at the scene of the crime, it’s not necessarily the perpetrator” (“Let’s Clear Up the Cholesterol Confusion Once and For All,” Heart, Health & Nutrition, p. 3, August 2008).
Yes, there is cholesterol in the plaque (deposits). But, it is not there because it has been eaten or because there is a high amount of it in the blood. It is not a simple matter of cholesterol creeping into the artery walls as mud settles to the bottom of a river. If that were the case, we would expect to see deposits form in the feet first and also form in the veins.
The evidence that Sheldon Zerden presented last month, which is conveniently ignored by the drug pushers and real-food substitute marketers, is that dietary cholesterol is not related to heart disease, nor is blood cholesterol level.
Passwater: Millions of people are lowering their blood cholesterol levels with statin drugs. Are the side effects really as rare as the pharmaceutical companies claim in the ads?
Zerden: The answer is no! One statin (Baycol) was taken off the market after two years of rhabdomyolysis (muscle breakdown) deaths. Dr. Duane Graveline is an expert on statin side effects. He suffered four amnesia episodes after taking four different statins for 10 years.
Passwater: Dr. Graveline has an excellent Web site on statin side effects (www.spacedoc.net). He points out that when a statin lowers blood cholesterol, it is, at the same time, reducing the synthesis of coenzyme Q10, dolichols, selenoproteins, Rho, glutathione and normal phosphorylation by a similar amount. This is the cause of the thousands of side effect reports largely unknown to the medical community. He has written three books on the side effects of statin drugs.
Zerden: Dr. M.F. Muldoon finds that some cognitive deterioration can be found in most statin users (23). Coenzyme Q10 (ubiquinone) levels plummet when statins are initiated. Neuropeptide formation is damaged by statin use, which is responsible for depression, irritability, hostility, aggressiveness, road rage behavior, accidents and suicides.
Passwater: Wow! Several scientists and physicians have emphasized in my columns many times over the years that anyone taking statins should also take coenzyme Q10 supplements. But, are statins really necessary in the first place?
Zerden: The forces of greed have ignored the science that argues against the use of statin drugs. A major study published in The Lancet by Drs. John Abramson and Jonathan Wright offers the following conclusion: “We have pooled the data from eight randomized trials that compared statins with a placebo in primary prevention populations at increased risk (24). Our analysis suggests that lipid-lowering statins should not be prescribed for true primary prevention in women of any age or for men older than 69 years. High-risk men aged 30–69 years should be advised that about 50 patients need to be treated for five years to prevent one event (heart attack). In our experience, many men presented with this evidence do not choose to take a statin.”
Passwater: That fits well with the remarks by Dr. Kilmer McCully of homocysteine fame. He reports on www.spacedoc.net/kilmer_mccully_cholesterol_2, “In an analysis of six major statin trials (EXCEL, 4S, WOSCOPS, CARE, AFCAPS, LIPID), the reduction of cardiovascular mortality ranged from –19% to –41% when expressed as relative risk reduction, but from –0.12% to –3.5% when expressed as absolute risk reduction. This statistical manipulation to make the results more impressive illustrates Mark Twain’s aphorism: There are lies, damn lies, and statistics. Thus, a multi-billion dollar drug industry depends upon using misleading interpretations of statistics showing trivial differences between treated and control groups.”
Dr. McCully also states, “In the even more massive Lipid Research Clinics (LRC) trial, 4,000 participants with very high cholesterol levels were selected from almost half a million men. After lowering cholesterol levels for seven years by the resin cholestyramine, fatal heart attack figures were 1.7% (in the treated group) compared with 2.3% (in the placebo group), a difference of 0.6%, or 12 individuals. The investigators expressed these differences as relative risk reductions of 19% and 30% by throwing out the denominators of their fractions.”
What a trick! Note how a small absolute reduction in events gets translated into a much larger relative reduction through the magic of taking a ratio of a ratio.
The JUPITER (Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin [Crestor]) study examined the ability of Crestor to reduce inflammation by studying C-reactive protein (CRP). CRP is an independent predictor of heart attacks. Well, the study suggested it did, but the control group had a disproportionate percentage of metabolic syndrome or people having a family history of heart disease. This is a serious flaw. However, the absolute reduction of cardiac events among the group taking Crestor was low and would occur only after years of taking the statin. If the statin reduces inflammation, that is good, but it doesn’t reflect on the cholesterol question. What is disturbing is that the group taking Crestor either saw their blood sugar levels rise or were newly diagnosed with diabetes.
How can we force the U.S. Food and Drug Administration (FDA) to release the adverse event reports on the statin drugs? Do we have to sue the FDA for this information?
Zerden: Thanks for mentioning the JUPITER Study. I discuss it thoroughly in my book. To address your question, that answer is given to me in an e-mail from Professor Joel M. Kauffman of Philadelphia, PA. He quotes from his book, Malignant Medical Myths: “You have to use the Freedom of Information Act and have your senators or representatives threaten the FDA for not responding.”
Tom Scherer, a civil rights activist, was started on Simvastatin (Zocor in the USA) and he developed myalgia and chronic fatigue. He e-mailed me on July 28, 2004 that he obtained data from the FDA under the Freedom of Information Act, however it required Congressional intercession. The data obtained were on adverse event reports actually reported from November 1997 through May 14, 2004 on Simvastatin. The data showed 11,589 individual adverse event reports, of which over 416 resulted in death! There were more than four adverse events per patient, 49,350 in all.
Passwater: Is there any validity at all to the Cholesterol Diet–Heart Hypothesis?
Zerden: The answer to this question is summed up beautifully by Dr. Uffe Ravnskov in his book, The Cholesterol Myths: “If a scientific hypothesis is sound, it must agree with all observations. A hypothesis is not like a sports event, where the team with the greatest number of points wins the game. Even one observation that does not support a hypothesis is enough to disprove it. The proponents of a scientific idea have the burden of proof on their shoulders. The opponent does not have to present an alternative idea; his task is only to find weakness in the hypothesis. If there is only one proof against it, one proof that cannot be denied and that is based on reliable scientific observations, the hypothesis must be rejected. And the Cholesterol Diet–Heart idea is filled with features that have repeatedly been proven false.”
Passwater: Well, you are preaching to the choir here. The responsibility of the scientists is to first confirm any observation, then set about trying to disprove the hypothesis, rather than attempting to confirm it. The scientist must try to figure out what would prove the hypothesis wrong and then set out to conduct that experiment. Instead, today, many scientists try to keep their funds rolling in by repeating similar studies that they believe will add to the confirmation. They look for ways to find supporting evidence. This is totally unscientific; 1,000 studies of the same event only confirms that event, not the hypothesis. Finding a few more ways that support the hypothesis merely ignores the possibility that the hypothesis is wrong and only prolongs the inevitable and wastes money. But, it builds careers. The hypothesis must be attacked and defended in order to be proven. To do otherwise is to waste time and money, but that is what many so-called scientists do today—make a career out of repeating the same event instead of trying to test the validity of the hypothesis.
First, the Cholesterol Diet–Heart Hypothesis proponents dictated “Don’t eat cholesterol.” Then, they wanted everyone to add a cup of corn oil (polyunsaturated fats) to their daily diet. Next, it was increase the polyunsaturated-to-saturated fat ratio, then cut back on all fats, then take resins to prevent absorption of cholesterol, and finally take statin drugs. All of this without observing meaningful decreases in death rate. As for blood cholesterol levels, it went from total cholesterol to “bad cholesterol” (LDL) ratio, to “good cholesterol” (HDL) to “bad cholesterol” level to LDL-c and apolipoprotein b and apolipoprotein a levels. None of these measures are dependent on cholesterol or fats in the diet. But, they are running out of excuses. As you so elegantly elucidate in your book, the Cholesterol Diet–Heart Hypothesis has failed at every test, therefore it is invalid.
The shame or crime is that so much time, brain-power and money has been wasted on a theory that was scientifically disproven decades ago. Only the vested interest of the fundraisers, natural food replacements (such as trans-fat margarines and egg substitutes) and drug companies kept it alive.
Even Big Pharma appears to have secretly given up on it even as they peddle their drugs. That is why they have switched from cholesterol-lowering studies to inflammation-reduction studies with the statins. Even then, there is no meaningful lowering of the death rate and they seem to be abandoning this line of study as well. I doubt if anyone can con the National Institute of Health into funding more expensive large-scale studies in the $500-million to $1-billion range, and I doubt if Big Pharma will invest its own money in more large studies. They must realize that better results can be obtained through better nutrition, especially with vitamins and minerals. Recently, Pfizer—the manufacturer of the statin, Lipitor—announced it will no longer develop medicine to prevent or treat atherosclerotic heart disease (25).
However, many of our readers will need more information before they can discard what they have been led to believe by so many commercials and fundraisers. Your new book contains many more facts and clear explanations. Is it available yet and if so, how can our readers get a copy?
Zerden: The book will be available through all major stores, and can be ordered from [email protected] or [email protected] The first printing was set to go to press last month.
Passwater: Since the Cholesterol Diet-Heart Hypothesis is wrong and both dietary and blood cholesterol and fats are not the cause of heart attacks, and cardiovascular exercises do not prevent heart disease, is there something that we should focus on? How about anti-inflammatory diets or Mediterranean-style diets? What advice do you offer to reduce the risk of heart attacks?
Zerden: The individual has the responsibility to eat an optimal diet with the best nutrition possible. In addition, he should supplement his diet with those minerals and vitamins that are still lacking. The best diet does not have everything we need to be in the best of health. Exercise is also important.
That is the best way to achieve a quality of life and provide the basis for an extended lifespan.
Passwater: Well, Dr. Ann Louise Gittleman states that your new book is “must reading for all of us who have been given distorted and misguided message that cholesterol is unequivocally bad in the food and blood stream. Like fine cream, the TRUTH always rises to the top and I predict that this book will be a runaway best seller.”
Some of the points we tried to bring out are that:
1. Dietary cholesterol is not the cause of heart disease. Moderation and variety of diet are important. It is more important to eat a nourishing balanced diet, rich in fish and fish oils and vitamins, than it is to fear eating cholesterol (cholesterolphobia). Vegetarians should consider algae or microorganism sources of EPA and DHA rather than rely solely on ALA.
2. There are many risk factors for coronary heart disease much more important than blood levels of cholesterol and more emphasis should be placed on these more meaningful risk factors.
Cholesterol in plaque does play a role in CHD, but it is not directly related to dietary cholesterol intake, except in the minor number of people with genetic polymorphisms (hereditary familial hyperlipidemia).
3. Antioxidant nutrients protect arteries and lipoproteins and reduce cholesterol plaque formation. Niacin, fish oil, tocotrienols and other nutrients favorably reduce existing cholesterol plaque.
Niacin has been shown to reduce mortality and nonfatal myocardial infarction (MI) in large clinical trials. For example, in the Coronary Drug Project, patients with a history of MI were randomized to receive niacin (n = 1,119) or placebo (n = 2,789) for 5 years. The risk of MI was significantly reduced in patients receiving niacin at 5 years, but niacin had no significant effect on mortality at this time point. However, in a 10-year follow-up of patients in this study (15 years after the study was initiated), mortality was significantly lower in patients who had been treated with niacin than in those who had received placebo.
In mid-November 2009, a time-released niacin formulation (Niaspan) was shown to be effective in reducing artery plaque, whereas the cholesterol- lowering drugs (Zetia and Vytorin) were not.
4. Statin drugs may have benefits such as anti-inflammation. Statins do lower blood cholesterol, but at a price of damaging many health pathways. Studies of statins have not shown that statins’ ability to lower cholesterol results in a meaningful ability to reduce overall death, except in a minor mathematically significant (but not health significant) manner. Some statins do reduce inflammation and this can lower heart disease risk in some risk populations. The physician should decide who might benefit from this reduction in inflammation and prescribe accordingly. However, any prescription for a statin should be accompanied by the advice to also consume CoQ10 supplements.
5. Statins reduce CoQ10 production and cause serious side effects in addition to the well-known rhabdomyolysis. Other health risks include cognitive decline, myositis, myalgia, pain, drowsiness and possibly cancer.
Thank you for writing the book and for sharing the information with our readers. It may be life-saving information for many if they shift their emphasis from cholesterol to the many scientifically well-supported risk factors. WF
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Reprinted with permission from Whole Foods Magazine, Dec 2009 and Jan 2010..
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