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Posts Tagged ‘diet’

Mediterranean Diet: What Accounts for the Health Benefit?

Posted by medconsumers on July 1, 2009

The Mediterranean diet is not only wildly popular around the world but also considered to be one of the most healthful diets of all that have received in-depth research attention. Yet it is unclear whether it is the wine, olive oil or some other component of the diet that largely accounts for the health benefits, chief among them is longevity.

An international team of researchers led by Dr. Antonia Trichopoulous produced the first study to assess the relative importance of the individual components of the Mediterranean diet. It was published last month in the online version of the British Medical Journal.

The 23,349 participants in the study were Greek adults who were free of heart disease, cancer, and diabetes at the start of the study. After 8 ½ years of follow-up, those who reported the strictest adherence to a Mediterranean diet showed a lower mortality rate than those who did not.

The researchers teased out the contribution of the nine dominant components of the traditional Mediterranean diet that account for the lower mortality. In descending order of importance, the components are: moderate consumption of alcohol (primarily wine), low consumption of meat and meat products, high consumption of vegetables, high consumption of fruits and nuts, high consumption of oil (mostly olive oil) and high consumption of legumes (e.g., beans, lentils).

There were some surprises in this study. The researchers found that high consumption of fish and seafood, cereals, and low consumption of dairy products had no effect on reduced mortality. The study was funded by the Europe against Cancer Program of the European Commission and the Greek Ministries of Health and Education.

An international team of researchers led by Dr. Antonia Trichopoulous produced the first study to assess the relative importance of the individual components of the Mediterranean diet. It was published last month in the online version of the British Medical Journal.

The 23,349 participants in the study were Greek adults who were free of heart disease, cancer, and diabetes at the start of the study. After 8 ½ years of follow-up, those who reported the strictest adherence to a Mediterranean diet showed a lower mortality rate than those who did not.

The researchers teased out the contribution of the nine dominant components of the traditional Mediterranean diet that account for the lower mortality. In descending order of importance, the components are: moderate consumption of alcohol (primarily wine), low consumption of meat and meat products, high consumption of vegetables, high consumption of fruits and nuts, high consumption of oil (mostly olive oil) and high consumption of legumes (e.g., beans, lentils).

There were some surprises in this study. The researchers found that high consumption of fish and seafood, cereals, and low consumption of dairy products had no effect on reduced mortality. The study was funded by the Europe against Cancer Program of the European Commission and the Greek Ministries of Health and Education.

Maryann Napoli, Center for Medical Consumers(c)

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The Healthy Skeptic

Posted by medconsumers on December 31, 2008

The Healthy Skeptic (University of California Press: 2008)

Sometimes it’s the opening anecdote that draws you into a book. In the introduction of The Healthy Skeptic: Cutting through the HYPE about your Health, author Robert J. Davis describes a youthful encounter that jump-started his own quest for truth. It was the early years of the low-fat-diet-for-all heart disease prevention message to the public. A college student at the time, Davis bragged to friends that his “highly enlightened family” (father a physician) shunned whole milk and drank only 2%, the type that is low in fat.

Another student challenged him saying, “2% milk is not really low in fat.” Incredulous, Davis cited the claim on the milk carton to support his contention. “Well, the carton lies; the fat content in 2% is closer to whole milk than to skim milk,” countered his challenger. “If you want low fat, you need to drink skim or 1%.” A trip to the library to consult a nutrition textbook led Davis to the conclusion that the other student was correct. “A glass of 2% milk has about five grams of fat, compared with eight grams of fat in whole milk and nearly zero in skim.”

Thus, the stage is set for the message of The Healthy Skeptic. Do your own searching for the evidence to support health claims. Davis, a health journalist and teacher at Emory University’s Rollins School of Public Health, makes a clear distinction between skepticism and cynicism. The former demands much more of us. He cites this quote from Marcia Angell, former editor-in-chief of The New England Journal of Medicine:

Cynicism is much easier than skepticism because it requires no distinctions. We needn’t distinguish between reliable evidence and unreliable evidence, between big dangers and small ones, between likely effects and unlikely ones, between the reasonable and the bizarre. Yielding to cynicism over skepticism is therefore an easy way out.

Thanks to the Internet, searching for reliable evidence is much easier today. The Healthy Skeptic does much of the research for you, taking on some of the most common health messages about foods, beverages, drugs, vitamins, herbal remedies, sunscreen and other products that bombard the public, mostly by way of the news media. Sometimes the hype is obvious; for example, the selling of yet-another exercise gadget in one of those middle-of-the-night infomercials.

Too often, however, it’s not so obvious that you are viewing a sales pitch. Exhibit A is the notorious video news releases, or VNRs, used for years by TV stations large and small. The VNR can look like an objective news item; for example, a reporter interviewing a physician who comes across as an independent expert about a new superfood or drug. VNRs are, in fact, what Davis calls “propaganda disguised as news,” bought and paid for by the company that makes the product. Sometimes that fact is mentioned briefly at the end of the VNR; sometimes it isn’t.

Celebrity pill-pushing can be mistaken for morning show chitchat. Years ago, actress Kathleen Turner did a round of TV and print interviews, discussing her “battle” with rheumatoid arthritis. Her mention of a helpful Web site in each interview came across as information-sharing—that is, until it was revealed in 2002 that Turner was a well-paid spokeswoman for Immunex, a bio-pharmaceutical company, which along with Wyeth, makes the RA drug Enbrel. The recommended Web site was theirs.

There was a backlash in the media after Turner was outed as an industry-funded shill. Now such financial arrangements are usually disclosed during the “interview,” but as The Healthy Skeptic notes, it can be acknowledged so quickly and offhand that the disclosure can go unnoticed.

In a section entitled, “Sunscreen Science,” we learn that sunscreens have become a $500 million-a-year business since these products were introduced in the early 1970s. But increased sunscreen use has not reduced the rate of melanoma, the deadliest form of skin cancer. In fact, studies have produced conflicting results about their most important protective benefit.

Some studies found sunscreen use decreases the rate of melanoma; some found usage increases the rate of melanoma; and others showed no effect either way. On the other hand, there is clear evidence that sunscreens protect against squamous cell carcinoma, which can be disfiguring but rarely fatal. As for basal cell carcinoma, the least dangerous and most common type of skin cancer, there is little solid evidence that sunscreens reduce its risk.

You are not likely to hear these uncertainties from your doctor. The leading supplier of information about sunscreens to the public as well as health professionals is the Skin Cancer Foundation. Despite its seemingly non-commercial name, Davis says the Foundation’s list of corporate benefactors reads like a “who’s who of sunscreen manufacturers”.

This small book does not simply expose such things as the “iffy assertions” of doctors who practice anti-aging medicine; the lack of definitive evidence about calcium’s benefit to bone health; the overselling of prevention and the exaggerated dangers of high cholesterol. It also provides a way of assessing public-health messages, their funding sources, and most important, the quality (or absence) of the supporting evidence.

(Disclosure: The Center for Medical Consumers is described as a “trustworthy source of information” in the chapter about cholesterol.)

Whether you choose to be a cynic or a skeptic is entirely up to you.

Maryann Napoli, Center for Medical Consumers© 2008

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Gary Taubes Challenges Conventional Wisdom on Diet, Weight Control and Disease

Posted by medconsumers on January 1, 2008

Good Calories, Bad Calories – Challenging the Conventional Wisdom on Diet, Weight Control, and Disease by Gary Taubes

If your doctor has ever told you to go on a low-fat diet, read this book. For 50 years the public has been told that dietary fat and excess calories are the cause of obesity, heart disease and other chronic illnesses. Journalist Gary Taubes, a correspondent for Science magazine, has spent years tracking down the scientific underpinnings for both assertions and found little to support them.

In “Good Calories, Bad Calories,” Taubes shows how the low-fat recommendation has steered Americans to higher consumption of refined carbohydrates, especially processed foods, sugar and white flour. It is the quantity and poor quality of the carbohydrates consumed today, he says, that are making us sick and overweight.

Initially, the low-fat guidelines were aimed solely at people who had suffered heart attacks. By the 1980s, the entire nation was advised to keep their cholesterol down and that meant a major reduction in saturated fats, which was, and still is, recommended to prevent heart disease. Taubes writes, “Though women were clearly meant to adhere to the low-fat guidelines, they had not been included in any of the clinical trials. The evidence suggested that high cholesterol in women is not associated with more heart disease, as it might be in men, with the possible exception of women under fifty, in whom heart disease is exceedingly rare.”

Taubes first presented his case against the low-fat diet in a 2001 Science magazine article entitled, “The Soft Science of Dietary Fat,” and one year later, in a New York Times Magazine article entitled, “What if it’s all been a Big Fat Lie?” With 115 pages of references and bibliography, his new book, “Good Calories, Bad Calories,” is clearly aimed at research scientists and physicians.

The book documents a big change that occurred in U.S. dietary recommendations. For well over a century, carbohydrates (white bread, potatoes, noodles, beer, etc.) were widely believed to be fattening. That conventional wisdom was displaced by the dietary fat/heart disease hypothesis promoted by two influential people of the 1950s.

One is Dr. Paul Dudley White, President Dwight D. Eisenhower’s cardiologist, who asserted that America’s heart disease epidemic began after World War II when the country started to eat more fat and red meat and less cereal and grains. The other is Ancel Keys, a University of Minnesota physiologist, who compared the diets of seven countries and found that those with high-fat intake also had a high rate of heart disease. He was also the first to promote the familiar message that dietary fat makes us fat.

Taubes found that the facts do not support the claims of these two early proponents of the low-fat diet. The American diet was high in fat and red meat prior to World War II, according to government food surveys. Drawing on the Bureau of Census records, Taubes argues that heart disease was not all that rare in the first half of the 20th century when better diagnostic technology became available (primarily the electrocardiogram).

By the 1950s, premature deaths from infectious disease and nutritional deficiencies were mostly eliminated, thereby moving heart disease up the list of common causes of death. And lastly, changes in classification of heart-disease deaths in 1965 account for the increase that began that year.

As for Keys’s study, the seven countries were selectively chosen to support his high-saturated fat/heart disease hypothesis. Had he randomly chosen France and Switzerland, for example, rather than Japan and Finland, Keys would likely have seen no heart-damaging effect from a diet high in saturated fat. (And Taubes wryly observes, there might be no such thing as the “French paradox,” referring to the country’s storied high intake of saturated fat and comparatively low rate of heart disease.) This criticism was leveled at Keys’s work when it was first published. Still the American Heart Association eventually approved his low-saturated fat hypothesis as if it were backed by strong evidence and word went out to the public at large when Keys made the cover of Time magazine in 1961.

The fat-restriction recommendation has been kept alive in the last three decades by a small, select group of obesity researchers with university affiliations. The most striking fact about the evolution of the low-fat diet consensus, says Taubes, is that it has been tested in only two trials—on a few hundred middle-aged men who had already suffered a heart attack. Results of these trials were contradictory. The diets tested thereafter were cholesterol-lowering diets that replaced saturated fats with unsaturated fats.

Big Test Fails

By the 1970s, the National Heart, Lung, and Blood Institute decided it was time to test the low-fat, low-cholesterol diet hypothesis with a large, expensive trial. The MRFIT, or the Multiple Risk Factor Intervention Trial, randomly assigned 12,000 men either to a treatment group or a control group. All were healthy middle-aged American men with cholesterol so high (over 290 mg/ml) they were thought to be at imminent risk of heart attack.

The men assigned to the treatment group were counseled to quit smoking, take drugs to lower high blood pressure and eat a low-fat, low-cholesterol diet. They were told to substitute margarine for butter; eat no more than two eggs a week, drink skim milk; and avoid red meat, cakes, puddings, and pastries. The men assigned to the control group were left to their own devices about eating and seeking medical care. All were followed for seven years.

When MRFIT was published in 1982, the disappointing results were summarized nicely in one Wall Street Journal headline, “Heart Attacks: A Test Collapses.” Though slightly more deaths occurred in the treatment group, Taubes shows how heart disease researchers did not let go of the dietary fat/heart disease hypothesis, even when proven wrong. In a subsequent large U.S. trial, all the participants were instructed to go on a cholesterol-lowering diet because it was considered unethical not to. Cholesterol-lowering drugs became the distinguishing feature of the treatment groups in subsequent trials.

While researchers continued to explore the idea that restricting dietary fat reduces the risk of premature death in population studies, some found that the opposite was true. The 1985 Honolulu Heart Program, for example, found that high-fat diets are significantly associated with a lower risk of total mortality, cancer mortality and stroke mortality. Questionnaires filed periodically by participants of another study called the Nurses Health Study showed that the less fat consumed, the more likely they would get breast cancer.

Finally, in 2001, the Cochrane Collaboration sought to answer the low-fat diet question once and for all when it published a systematic review of the world’s best quality trials that had randomly assigned healthy adults to go on a “reduced or modified dietary fat” diet or continue eating as usual. The 27 trials that met the predetermined high-quality criteria had a combined total of about 10,000 participants. The trials lasted an average of three years. The Cochrane reviewers found that the low-fat or cholesterol-lowering diets had no effect on longevity and “no significant effect on cardiovascular events.”

The topic of weight control takes up about half the book. Though weight loss has long been promoted as the additional advantage of going on a low-fat diet, studies failed to prove this purported benefit as well. A 2002 Cochrane review of all relevant clinical trials (28 in all) concluded, “Low-fat diets induced no more weight loss than calorie-restricted diets, and in both cases the weight loss achieved was so small as to be clinically insignificant.” Conversely, Taubes cites trials showing that the high-fat diet, most notably the Atkins diet, results in more weight loss.

Total immersion in the last two centuries’ worth of research has convinced Taubes that dietary fat, including saturated fat, is not a cause of obesity, heart disease or any other chronic disease of civilization. Instead: “Through their direct effect on insulin and blood sugar, refined carbohydrates, starches and sugars are the dietary causes of heart disease and diabetes. They are the most likely dietary causes of cancer, Alzheimer’s disease and other chronic disease of civilization.” And contrary to conventional wisdom, obesity is not a disorder of overeating. Rather it is a disorder of fat accumulation due to too much insulin. (See related interview below.) What’s more, Taubes concludes that exercise is highly overrated as a means of weight control.

Taubes found enough evidence to warrant a clinical trial that tests his carbohydrates-make-you-fat-and-sick hypothesis. But he has no faith in the carbohydrate-restricted diet trials planned by the U.S. National Institutes of Health and the Dr. Robert C. Atkins Foundation because they will include only obese or overweight participants and are designed to test only weight loss.

What Taubes would like instead is a trial with healthy lean and normal-weight participants followed long enough to see whether an excess of refined carbohydrates will make them fat and develop chronic diseases. Another suggested trial would include a spectrum of participants—lean to obese—including many who have metabolic syndrome and/or type 2 diabetes.

Trials like these are not likely to take place—at least not in the near future—because a carbohydrate-restricted diet is by definition a fat-rich diet, and the medical community has been telling the public for the last half century that such a diet is dangerous. In the meantime, read this book and make up your own mind about which hypothesis has the most merit.

Maryann Napoli, Center for Medical Consumers © January 2008

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Statins and Mediterranean Diet

Posted by medconsumers on February 1, 2007

One might reasonably expect the U.S. government’s cholesterol-treatment guidelines to be firmly based on scientific evidence. Certainly, that was the claim of the National Cholesterol Education Program when it issued an updated report in 2004. What alarmed some researchers and consumer advocates at the time was the expansion of statin use to include people who do not have heart disease but are supposedly at “moderately elevated risk” for developing it.

The updated guidelines would put an additional 23 million Americans on statins for the rest of their lives. A cloud of doubt hung over the entire issue once it became known that the majority of physicians who established the guidelines had financial ties to companies that make statin drugs.

Statins, the top-selling class of drugs in history, are cholesterol-lowering drugs that include atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), fluvastatin (Lescol), simvastatin (Zocor) and rosuvastatin (Crestor). Their benefit to people with heart disease is proven, but there is a controversy regarding the use of these drugs by everyone else. Three-quarters of all Americans now on long-term statin therapy do not have heart disease.

In a recent issue of the medical journal, Lancet, John Abramson, MD, Harvard Medical School, and James Wright, MD, University of British Columbia, Vancouver, co-authored a commentary entitled, “Are Lipid-Lowering Guidelines Evidence-Based?” They conducted an analysis of all the major trials in which participants were randomly assigned to take either a statin or a placebo. The seven trials that included adults between 30 and 80 years old who already have heart disease clearly showed that statins lower the risk of a cardiac death as well as a death from any cause.

However, their analysis of the other trials that included healthy but high-risk people without heart disease showed that statins should not be prescribed to women of any age who do not have heart disease or diabetes, or to men older than 69 years who do not have heart disease or diabetes because no benefit was shown for them.

There is a modest benefit for men aged 30-69 years who are at high risk of developing heart disease. Out of 50 high-risk men taking a statin every day for five years, only one avoids a “cardiac event” —that is, a heart attack or heart-related death. Put another way, out of every 50 men who stay on statins for five years, 49 risk an adverse drug reaction for no benefit. “In our experience,” wrote Drs. Abramson and Wright, “many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall benefit health.”

*****

What follows is an interview with the lead author of this analysis, John Abramson, MD, who is also the author of the 2004 book entitled, “Overdosed America” and serves as an expert consultant to plaintiffs’ attorneys in litigation involving the drug industry including Pfizer and Lipitor. He is interviewed by Maryann Napoli.

MN: Whenever I write about statins, I get calls from readers that indicate many are misled about their level of risk. Typical is the healthy woman over the age of 65 pressured to take statins by her doctor who says that she is at high risk for a heart attack solely because of age and high cholesterol.

JA: 1) The evidence shows that the higher her cholesterol, the longer she will live; 2) no trial shows that statin therapy will benefit her; 3) people over 65 who exercise routinely, eat a Mediterranean-style diet, don’t smoke, drink moderately, will have a 60% lower rate of death than the people who don’t do these things.

MN: That one trial with people over 70, called PROSPER (PROspective Study of Pravastatin in Elderly at Risk), is often misrepresented.

JA: This trial clearly showed the limited benefit of statins in the elderly. For those who already have cardiovascular disease, taking a statin reduces the risk of heart attack or cardiac death. But it also showed that people in this age range who are at increased risk of, but do not have, cardiovascular disease do not benefit from taking a statin. Importantly, the study also found that at four years, there was one extra new cancer for every 70 people taking a statin. No reduced risk of stroke and no benefit for people without cardiovascular disease and an increased risk of cancer, yet millions of elderly Americans without heart disease or diabetes are taking these drugs because they and their doctors are misled into believing that clinical trials have shown that statins are beneficial.

MN: And people who have had a heart attack?

JA: Statins are definitely helpful for people who have already had a heart attack. Still, the Lyon Diet Heart Study shows how much more effective a healthy diet is in reducing the risk of heart attack for these folks. The participants were randomly assigned to receive counseling about a Mediterranean-style diet (see end of article) or a standard post-heart attack diet. Those who went on the Mediterranean-style diet developed 72% less heart disease than those in the control group. There was also a 56% lower death rate and 61% less cancer than the people in the control group. Simply eating a Mediterranean-style diet is nearly three times more effective at preventing recurrent heart disease and death in post-heart attack patients than is taking a statin. Even more surprising, those on the Mediterranean-style diet did not have lower cholesterol than those eating the standard post-heart attack diet. So when your doctor tells you to get your cholesterol down…keep that in mind.

MN: Lifestyle changes aren’t given much attention.

JA: The vast majority of communication about heart disease is influenced by the drug companies. They focus on cholesterol, rather than diet, exercise, and not smoking because their primary responsibility is to maximize the financial return to their investors, and that’s where the money is. All but one of the major statin trials was funded by a company that makes statins.

MN: That should make us all wary—studies show that the majority of drug company-funded studies produce results favorable to their product.

JA: The ALLHAT [Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial] was the only one of the 14 major statin trials included in the most recent review [published in the Lancet in October 2005] not funded by a drug company. It included a good mix of people: men and women with and without heart disease and/or diabetes. Half of the participants were randomly assigned to be treated with a statin and half to go to their regular doctor and do whatever he or she thought was right. By the end of the study, 26% of the people assigned to “usual care” had been put on a statin by their doctors and 77% of those in the statin group were still taking the statin (the others discontinued because of side effects, other medical conditions, etc.). But the results showed that there was no less heart disease or death in the group with three times as many people taking statins.

MN: These results seem to be widely misperceived.

JA: One of the reasons is a misleading editorial that accompanied the publication of ALLHAT in the Journal of the American Medical Association. It stated: “Physicians might be tempted to conclude that this large study demonstrates that statins do not work; however, it is well known that they do.” That’s not quite what I think of as evidence-based medicine. The editorialist actually had the chutzpah to suggest that statins may be less effective when they are prescribed by primary care physicians, as they were in the ALLHAT, than by cardiologists. At the time of the editorial, the writer had financial relationships with at least seven drug companies. He is now employed by Merck, which makes Zocor.

MN: All but two of the statin trials failed to report their serious adverse events, defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, requires prolongation of hospitalization, or results in significant disability.

JA: The statin trials that report only the drug’s effects on heart disease are not presenting what we all really need to know. The most important question is: What is the overall effect of taking the drug? In other words, if a statin decreases the risk of heart disease but does not reduce the overall risk of serious illness or death unrelated to heart disease, is it worth taking? And the difficulty of answering this question ought to lead people to wonder if there are alternative ways to reduce the risk of heart disease.

MN: Why do journals allow drug companies to publish only heart-related results of their trials?

JA: Medical journals are not fulfilling their responsibilities when they publish trial results and omit all serious adverse events and deaths from all causes.

MN: Any parting thoughts?

JA: People ask, “Why can’t I just take a pill, eat what I want and forget about going to the gym?” And I say to them: If the pill worked, that would be a good question, but there just isn’t any evidence from clinical trials showing that statins are beneficial for women or older men who don’t already have heart disease or diabetes. Healthy lifestyle changes are a more effective, less expensive, and safer way to reduce your risk of heart disease and improve your chances of staying healthy overall.

For information on the Mediterranean-style diet: go to www.americanheart.org and type into the search box: Lyon Diet Heart Study.

Maryann Napoli, Center for Medical Consumers ©

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Cholesterol Skeptics: Conference Report

Posted by medconsumers on June 1, 2003

Cholesterol Skeptics and the Bad News about Statins

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 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.

Read our articles that have critiqued statin drugs over the years: “(Almost) Everything you need to know about statins,” “Statins: Low Odds of benefit,” “Take a closer look at statin’s benefit,” and “Failed Vytorin study raises questions about cholesterol.”

Maryann Napoli, Center for Medical Consumers(C)

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