THE SCHEME TO INTERVENE
The Federal government has issued draconian new guidelines for cholesterol-lowering to prevent heart disease. The guidelines are aimed at all Americans age 20 and over, with wastelines greater than 40 inches and whose LDL cholesterol levels are over 100. “Many more people are eligible for treatment under the new guidelines,” said one commentator, “because the population has gotten more overweight.” Recommendations include cutting intake of saturated fats to less than 7 percent of total calories and cholesterol intake to less than 200 mg per day. “At risk” individuals are encouraged to consume cholesterol-lowering margarines and salad dressings and to eat lots of grains, beans, fruits and vegetables—the kinds of foods that make many people gain weight. Most importantly, the government recommendations will make 36 million people candidates for cholesterol-lowering drugs—three times the number currently taking them. Drugs for cholesterol-lowering already constitute a huge market. Sales of Lipitor, for example, bring in more than $5 billion per year for Pfizer. With the new recommendations, pharmaceutical stock prices naturally have shot up. The more stringent guidelines and harsh tone of the report are said to be necessary because Americans are not taking prevention of heart disease seriously enough—which means that sales of cholesterol-lowering drugs and lowfat, cholesterol-lowering imitation foods are not increasing fast enough to please the multinational corporations that sell them. The guidelines are also well timed to stem the fallout from the publication of “The Soft Science of Dietary Fat,” an explosive exposé in the March 30 issue of Science. Author Gary Taubes points out that 50 years of mainstream nutritional research and hundreds of millions of research dollars have not proved that eating a lowfat diet will help you live longer. Taubes notes that the principal political supporter of the lowfat agenda was Senator George McGovern, who had spent some time on the severely lowfat Pritikin diet. . . before dropping out of the program. The McGovern Committee’s “Dietary Goals for the United States,” which almost singlehandedly changed nutritional policy in the US, was written by a vegetarian, Nick Mottern, a former labor reporter with no background in nutrition. Thus have government, science and industry put their curse on healthy traditional foods and ushered millions of perfectly healthy Americans into the jaws of the medical care system.
The drugs that so many Americans now take to lower their cholesterol are called statins. They work by blocking an important enzyme the body uses to make cholesterol. Researchers say that statins are completely safe, even though many studies show a correlation of statin use with increased risk of cancer, intestinal diseases, stroke, depression, accidents and suicide. In May, a retired physician participated in an interview on The People’s Pharmacy, a national radio show, to describe another side effect—memory loss. Dr. Duane Graveline said he experienced bouts of total amnesia while taking the drug. Spokesmen for Pfizer, the makers of the statin-drug Lipitor, say that there has never been a single case of amnesia reported in any of the clinical trials on the drug. Nevertheless, a warning of potential problems with memory, insomnia or depression is listed on the product label. Dr. Graveline says he would never take another statin drug and is concerned that doctors may attribute cognitive problems in their patients to aging or Alzheimers rather than entertain the premise that statin drugs might be the cause. (The May 28 issue of US News & World Report follows its article on the new guidelines with an article on Alzheimers, oblivious of the irony.) Even worse, he said, is the possibility that doctors may prescribe statins to people whose memory loss might be disastrous, such as airline pilots or school bus drivers.
ET TU, DIABETES
The new guidelines do not spare diabetics, whose condition is now included as a risk factor that must be treated with lowfat diets high in grains and other carbohydrates. This comes in the wake of a study by Dr. James Hayes, an endocrinologist and director of the Limestone Medical Center in Wilmington, Delaware. Whereas most type-II diabetics are encouraged to get at least 60 percent of their calories from carbohydrates, he put his diabetic patients on an 1800-calorie diet with 50 percent of caloric intake from fat and just 20 percent from carbohydrates. Ninety percent of the fat content in the diets was saturated fat. The patients showed an impressive weight loss and normalization of blood parameters without ketosis.
CHOLESTEROL AND THE ELDERLY
Damage control experts are dealing with yet another study that disproves the theory that high cholesterol levels are a bad thing. Researchers participating in the Honolulu Heart Program measured cholesterol levels in 3572 Japanese American men (aged 71-93) and compared changes in cholesterol levels over 20 years with all-cause mortality. In general, cholesterol levels fell with increasing age, but the researchers were astounded to find that the earlier patients start to have lower cholesterol concentrations, the greater the risk of death. Furthermore, those with higher levels of cholesterol had better hemoglobin status and hand grip strength. In other words, when cholesterol levels go down in the elderly, so does physical function and they become frail. “We have been unable to explain our results,” said the investigators. They urged “a more conservative approach in this age group.” What that means is that it is not a good idea to put the elderly on lowfat diets and cholesterol-lowering drugs, but don’t expect to see this finding translated into medical policy anytime soon (The Lancet 8/4/01 358:351-355).
AMERICA ON PARADE
What America Eats is the subject of a special issue of Parade Magazine (November 11, 2001). In it we learn that the average amount of time spent preparing the family dinner is 33 minutes; that one-third of Americans buy more convenience foods than they did just two years ago; that pizza is America’s favorite food; and that 66 percent of Americans eat breakfast at home—usually cold cereal. Sixty-eight percent of Americans eat cold cereal as a snack and 27 percent admit to having cold cereal for dinner. Americans are eating more chicken, fish and veggie burgers. Still, 82 percent of Americans eat cold cuts. Nutrition advice includes eating more fish, more tea and more monounsaturated fats like olive oil and canola oil. Since Americans are eating less meat and fewer eggs, foodmakers are fortifying “healthier” foods with choline, a nutrient needed for brain development, which we used to get from meat and eggs. A Dr. Isadore Rosenfeld advises Americans to eat a “good” breakfast of orange juice, skim milk (or soy milk) and cereal, but to avoid bacon, ham and sausages. “Such a breakfast can only lead to diabetes, hypertension, obesity and hardening of the arteries, and is . . . worse than no breakfast at all,” he says. “Experts” providing food advice include the CEOs of Nestlé, ConAgra, Kraft and Campbell Soup, who predict that next year Americans will use more processed foods. Interspersed with this ageless wisdom are advertisements for drugs to treat menopause, heartburn and osteoarthritis, and mattress pads for fibromyalgia sufferers.
MORE CHOLESTEROL MADNESS
In spite of widespread cholesterol-lowering measures, heart disease remains the top killer in the US, according to a new report (Washington Post, January 1, 2002). Almost one million Americans per year die of heart disease, twice as many as die from cancer. The American Heart Association’s insistence that we be more diligent in following a lowfat diet represents the triumph of hope over experience. Ever since the mid-1930s, when Americans began to consume supposedly lower-fat processed foods based on vegetable oils, the rate of heart disease has continued to climb. And, naturally, the report is being used to promote greater use of drugs to lower cholesterol. In fact, according to an article in the Wall Street Journal by Thom Burton, many insurers now grade doctors’ performances and dole out monetary bonuses and penalties based on measuring and “improving” patients’ cholesterol levels. And the fastest and easiest way for doctors to lower cholesterol is to prescribe a powerful statin like Pfizer’s Lipitor. The new government guidelines are structured in such a way as to transform virtually every American into a candidate for cholesterol-lowering drugs, and Pfizer’s profits are climbing. Income for the huge pharmaceutical company rose 38 percent in the last quarter of 2001 to $1.93 billion. Karen Katen, president of Pfizer’s human pharmaceuticals group, said Lipitor “still has enormous room to grow” because of “widespread under-diagnosis of high cholesterol” (Wall Street Journal, January 24, 2002). Enormous creativity has been shown in increasing the market for these expensive and toxic drugs, including drug-discount cards for poor Medicare beneficiaries, American Heart Association literature aimed at Blacks and Hispanics promoting use of vegetable oils and egg substitutes, and smiling football coaches in full page ads promoting statin drugs. Meanwhile, yet another study has linked low cholesterol levels with depression (Psychosomatic Medicine 2000, 62), creating new customers for antidepressants. It’s a crazy system based on fear and a misplaced respect for what passes as medical science.
NEW GUIDELINES, MORE PATIENTS
The “New Cholesterol Guidelines” have turned tens of thousands more healthy people into patients, “eligible” for cholesterol-lowering statin drugs. When a correspondent asked the National Heart, Lung and Blood Institute (NHLBI) why there were no open meetings required for the development of the new standards, and why the New Guidelines were not published in the Federal Register, he received the following amazing reply: “. . . the guidelines for cholesterol management released on May 15, 2001 were developed by a panel of experts—the Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III [ATP III])—convened by the National Cholesterol Education Program, an educational program coordinated by the National Heart, Lung and Blood Institute. The ATP III panel is not an advisory committee to the NHLBI but rather a group of recognized experts providing their scientific judgement about cholesterol management to clinicians. The panel’s recommendations for clinicians are based on a thorough review of the scientific evidence by the panel. The guidelines developed by the ATP III are not regulations and health professionals are not required to follow them.” The “recognized experts” include Drs. Grundy, Hunninghake, McBride, Pasternak, Stone and Schwartz, all of whom have received consultant fees from the producers of statin drugs.
NEW CHOLESTEROL TEST, MORE PATIENTS
Atherotech, Inc., a leading cardiodiagnostic company, has announced the completion of a private offering of $11.5 million in financing to be used to further the “rapid widespread adoption of the company’s VAPTM (Vertical Auto Profile) cholesterol test as the new standard of care in cholesterol risk assessment.” The test “detects 50 percent more people at risk for heart disease than the traditional cholesterol panel.” According to a company press release, “The VAP Test is available in 43 states, and we expect another stellar year in 2002 as physicians convert to the VAP Test to comply with the recently released NCEP ATP III guidelines.”
MORE GRUMPY PATIENTS
Scientists have identified low testosterone as the cause of “Irritable Male Syndrome,” the grumpy, noncommunicative, moody male that makes life miserable for his wife and family (Examiner, May 26, 2002). With the New Cholesterol Guidelines and the new VAP cholesterol test, families can expect more exasperating behavior in their menfolk—because testosterone is made out of cholesterol. When you lower cholesterol with lowfat diets and statin drugs, the results can be tragic for all involved, as chronic low cholesterol levels lead to depression and irrational anger. The whole cholesterol story adds up to an incredible phenomenon—drug companies promoting a dangerous drug as though it were government policy, new guidelines and new tests to convince the majority of US adults that they need to lower their cholesterol, and then the tragic consequences—black moods, sudden anger, hell on earth. . .
The press has been quick to publicize a new study claiming “Teen Vegetarians Healthier Than Meat-Eaters.” What did the researchers deem “healthier?” The vegetarian teens had lower intakes of fat, including saturated fat, and ate more vegetables. (Never mind that the vegetarians “drank more diet soda and caffeine,” reflecting the desire of most of the teenagers to keep weight off.) There was no front page coverage for a study showing that animal protein consumption is associated with greater bone density in the elderly (Am J Epidemiol 2002;155:636-644), nor for a study showing that blood homocysteine levels are higher in vegetarians than in meat eaters (J Nutr 2002 Feb;132(2):152-8), implying that vegetarians are more at risk for heart disease. And, finally, steak lovers will be pleased to learn that researchers in Lyon, France found that processed meats were linked to colon cancer but consumption of fresh (unprocessed) red meat does not raise the risk of colon cancer (www.msnbc.com/news/591170.asp).
A NEW ENEMY
Now that the public has discovered that half of all heart attacks occur in individuals with “normal” or even low cholesterol levels, the American Heart Association spin doctors have found a new enemy of the cardiovascular system—it’s not cholesterol after all, but inflammation (Associated Press 8/5/2002). Replacing “the standard theory through the modern era of cardiology,” low-grade inflammation is said to cause plaque embedded in the arteries to loosen, thereby triggering fatal blood clots. “The implications of this are enormous,” says Dr. Paul Ridker of Boston’s Brigham and Women’s Hospital. “It means we have an entirely other way of treating, targeting and preventing heart disease that was essentially missed because of our focus solely on cholesterol.” The new way of treating heart disease will consist of blood tests to measure a substance called C-reactive protein, which is a marker for inflammation occurring anywhere in the body (not just in the arteries). But if you think that the new way of treating heart disease will include abandoning the widespread use of statins, those cholesterol-lowering drugs that have so many dreadful side effects, think again. “Many people ordinarily considered at low risk will probably be put on statin drugs, which lower inflammation as well as cholesterol.” Thus, by declaring a new enemy, the medical profession can put just about everyone on statins, which magically not only lower cholesterol but also have a slight effect on inflammation. And because animal fats contain arachidonic acid, a substance falsely accused of causing inflammation, doctors can continue to recommend avoidance of saturated fats. Never mind that saturated animal fats provide vitamins A and D, nutrients the body uses to prevent inflammation.
In 17 years of practice in Tyler, Texas, Dr. Peter H. Langsjoen has seen a “frightening increase in heart failure secondary to statin usage.” Says Langsjoen: “Over the past five years, statins have become more potent, are being prescribed in higher doses and are being used with reckless abandon in the elderly and in patients with ‘normal’ cholesterol levels. We are in the midst of a CHF epidemic in the US with a dramatic increase over the past decade. Are we causing this epidemic through our zealous use of statins? In large part I think the answer is yes.” Langsjoen has compiled a review of studies showing that statins interfere with Co-enzyme Q10 (CoQ10), which is essential for muscle function—and the heart is a muscle. This phenomenon is well known to the drug companies because Merck & Co has two unused 1990 patents combining CoQ10 with statins to prevent CoQ10 depletion and its attendant side effects. Statins have created a life-threatening nutrient deficiency in millions of otherwise healthy people while the drug companies have sat back “with arrogance and horrific irresponsibility and watched to see what happens. As I see two to three new statin cardiomyopathies per week in my practice, I cannot help but view my once great profession with a mixture of sorrow and contempt.” Langsjoen has piloted a citizen petition to the FDA calling for a black box warning on the statin package insert information. Langsjoen and colleagues “do not expect any response from the FDA, but ten years from now when the full extent of statin toxicity becomes painfully evident, at least we can, in good conscience, know that we tried and who knows, sometimes small sparks may spread in dry grass (www.redfl agsweekly.com/features/2002_july08.html).”
COPPER AND HEART DISEASE
While public health officials continue to promote lowfat diets and cholesterol-lowering statin drugs as the solution to heart disease, many other good theories go ignored. One of these theories has to do with copper deficiency. A researcher named Leslie M. Klevay has shown that copper deficiency leads to atherosclerosis in many animals (J Am Coll Nutr 1998;17(4):322-326). Copper is needed for a number of important biochemical reactions. The polymerizing enzyme lysyl oxidase (LOX) is copper dependent. This enzyme helps form the internal elastic lamina (IEL), a thin elastic layer in the arteries which is separated by only one endothelial cell layer from the blood. Without adequate copper, the lamina is not sufficiently elastic and intimal thickening results—and a recent theory of heart disease has to do with abnormal thickening of the arteries, followed by inflammation and the release of blood clots. Copper is also necessary for the formation of thyroid hormones and the production of heme iron in blood cells. Both milk and meat are deficient in copper, and the small amount of copper in most plant foods is difficult to absorb. (Legumes and whole grains that have not been properly prepared can actually block the absorption of copper.) The only reliable source of copper is liver, especially that of lamb and other ruminants. There was thus a very good reason for people to eat liver once a week, something our government now tells us not to do. . . in order to avoid heart disease.
TRANS FATS AND INFLAMMATION
The latest establishment theory on heart disease posits low-grade inflammation in the arteries as a cause, leading to the release of blood clots followed by heart attack. A new study directly fingers trans fats from stick margarine as a cause of inflammation. A recent study showed that consumption of stick margarine in human subjects provokes an increase in the production of inflammatory prostaglandins associated with atherosclerosis. Neither liquid soy oil nor butter had the inflammatory effect (J Lipid Res 2002 Mar;43(3):445-52). This research was carried out at the USDA Human Nutrition Research Center on Aging at Tufts University. Jean Mayer and Alice Lichtenstein of Tufts have been major spokespersons for avoiding foods containing those “evil” saturated fats. We expect that reports on this study will include the suggestion to consume toxic liquid vegetable oils and low-trans soft spreads instead of stick margarine, without any suggestion that we should go back to butter.
AND IF IT TASTES GOOD, YOU MUSN’T EAT IT!
A new reason for not eating delicious, satisfying foods like cheese, meat and chocolate, says soy-promoting Neal Barnard, MD, of the Physicians Committee for Responsible Medicine, is that these foods create opiates in the brain and make you feel good. “There’s a reason why people call these things ‘comfort foods,’” says Barnard. “They’re getting an opiate when they eat them.” New research indicates that many traditional high-fat foods stimulate the production of dopamine, a brain chemical associated with intense good feelings. Naturally, the food puritans are not pleased. Surely Mother Nature did not mean for us to enjoy our food! Someone must be punished for foisting comfort foods on the public and since we can’t sue Mother Nature, Barnard suggests we sue the fast food chains who’ve gotten the public “suckered into high-fat meals—like cheeseburgers and shakes. . .” (Washington Times, June 15, 2003). The food chains need to be sued, all right, not for the natural foods they serve, but for using imitation foods, particularly partially hydrogenated vegetable oil, which doesn’t tickle our pleasure centers in quite the same way and makes us eat and eat and eat in a desperate attempt to get into the comfort zone.
THE FEAR FACTOR
When the guilt trip doesn’t work, the food industry turns to the other potent weapon in their arsenal: fear. A good example can be found in the recent headline, “Women Who Eat High-Fat Foods Could Be Doubling Their Risk of Breast Cancer, Scientists Say.” This and similar pronouncements heralded a new study published in International Journal of Cancer: “Eating
high-fat red meats and dairy products such as cream [one of those comfort-zone foods] may increase the risk of breast cancer in premenopausal women,” says nutrition researcher Eunyoung Cho of the new study. “I would not recommend that [Atkins] diet for premenopausal women unless they replace red meat with poultry and fish.. . . Breast cancer risk increases 58 percent by eating animal fat.” What the study really showed was that if your diet contains 14 percent of calories as animal fat, your chances of getting breast cancer are 0.68 percent; if your diet contains 18-21 percent of calories as animal fat, your chances of getting breast cancer increase to 0.88 percent; and if your diet contains more than 21 percent animal fat, your chances of getting breast cancer actually go down to 0.73 percent. Spokesmen for the study used every trick in the book to make these trivial results seem scary. In addition to the incredible hype over minor differences, they divided the subjects into unequal quintiles (the highest quintile of 21-46 percent had the greatest range); determined fat percentages by dietary recall that was surveyed only two times during the study; neglected to mention the fact that there were twice as many smokers in the group with highest animal-fat consumption compared to lowest; and failed to report on many studies showing that animal fats have no effect on breast cancer rates (Int J Cancer 2003 Mar;104(2):221-7).
A new TV ad in Canada advises viewers to “Ask your doctor about the Heart Protection Study from Oxford University.” This was a large study which showed a small but statistically significant relationship between treatment with statin drugs and lowered rates of heart disease—as one commentator put it, take a massive group and follow them long enough and something statistically significant will come out. But what the ad doesn’t tell you is that there are two recent studies, both of large groups, where treatment with expensive statin drugs made no difference in outcome. In the ALLHAT study, deaths in the second largest cholesterol-lowering trial ever were equal in both the treatment and control groups. In the ASCOT study, just published in The Lancet, those taking Lipitor fared only slightly better than those taking a dummy pill. Neither study made mention of the side effects experienced by those on cholesterol-lowering drugs, including neuropathy, muscle wasting leading to crippling back pain, heart failure, liver failure, cancer, weakness, fatigue, depression and memory loss. Instead, the industry is claiming that statin drugs can help patients reduce anxiety, depression and feelings of hostility! (The Record 8/11/2003). Now throw in “the promise” that statins will protect against Alzheimer’s, multiple sclerosis and osteoporosis (Newsweek August 14, 2003) and you’ve come up with a scheme aimed at putting the entire population on expensive drugs that have subtle but serious side effects. Fortunately, not all of the people are fooled all of the time and statin sales have not lived up to expectations. A recent article in the Wall Street Journal carried the title: “The Statin Dilemma: How Sluggish Sales Hurt Merck” (August 25, 2003).
We’ve heard fantastic claims about various nostrums, but the hype surrounding a new remedy called the “polypill” takes the cake. Proposed not by crackpots but by two distinguished scientists, Nicholas Wald, Professor and Head of Wolfson Institute of Preventive Medicine, and Malcolm Law, a Professor at the University of London and University of Auckland in New Zealand, and promoted by none other than the prestigious British Medical Journal (and also hyped in the tabloids), the polypill will contain six different ingredients: a statin to lower LDL-cholesterol, three (yes three) blood pressure drugs (a beta blocker, a diuretic and an ACE inhibitor), aspirin to reduce clotting tendencies and folic acid thrown in to prevent high homocysteine levels. Richard Smith, editor of the British Medical Journal, claims that the issue introducing the polypill is possibly the most important issue of the journal in the last 50 years. He urges readers to save their copy since it would likely become a collector’s item because of the Wald and Law contributions. Wald and Law claim that the polypill will have “a greater impact on the prevention of disease in the western world than any other known intervention.” There have been absolutely no studies on the proposed panacea but the inventors insist that they can prevent almost nine out of ten heart attacks and four out of five strokes in anyone with cardiovascular disease and everyone age 55 or older. Claims for the efficacy and safety of the polypill are based solely on meta-analyses and statistical analyses of clinical trials. This magic bullet will have very few side effects, say the promoters, because lower-than-normal dosages will be used. For those who believe all this, we have a bridge for you.
Here’s a trend we all could have predicted—children and teenagers are now the targets of cholesterol-lowering diets and drugs. Worried parents are taking their healthy children to pediatric cardiologists who duly put them on diets that deny them eggs, butter, whole milk and meat, while prescribing cholesterol-lowering margarines like Take Control and Benecol, soy foods and “high-fiber” foods like oat bran, oatmeal, beans, barley and fruit. If dietary changes don’t bring cholesterol levels down, the children get medications—resin powders for children and statins, including Lipitor, for adolescents. Some doctors have objected, but Peter Kwiterovich, director of the lipid center at Johns Hopkins Children’s Center in Baltimore says ignoring high cholesterol in children is taking a chance with their hearts later in life. “I think every child should have their cholesterol measured and be assessed for obesity, at a minimum, and then appropriate interventions come into play.” Marc Jacobson, head of the center for atherosclerosis prevention at Schneider Children’s Hospital in New York and a member of the American Academy of Pediatric’s nutrition committee agrees. Children, he says “definitely should be screened, and they definitely should be treated if found to be at high risk” (Washington Post, December 2, 2003). No one has described the results of cholesterol-screening in children better than Dr. Uffe Ravnskov: “At best, emphasis on lowering cholesterol in children will create families of unhappy hypochondriacs, obsessed with their diet and blood chemistry. At worst, it will have profound and unfortunate effects on the growth of children . . .”
CHOLESTEROL AND MEMORY
Cholesterol-lowering measures may also have profound and unfortunate effects on their minds. A recent study found that increasing levels of LDL- and total cholesterol are associated with beneficial effects on memory in middle-aged women (J Neurol Neurosurg Psychiatry 2003;74:1530-1535). The researchers warned: “Possible cognitive effects of cholesterol reduction should be considered in future studies of lipid-lowering agents.” But the prescription-happy pediatric cardiologists aren’t exercising the same caution, blithely ratcheting down cholesterol levels in children with no thought as to how such measures will affect their neurological development or their ability to reach adulthood with all their mental facilities intact.
Good science requires that theories conform to the evidence; if evidence that contradicts a theory emerges—even a single piece of evidence—then scientists are obliged to come up with a different theory. But in the case of the lipid hypothesis for heart disease, contradictory evidence is given the status of “paradox.” The theory is never abandoned, just promoted with more vigor. The latest “paradox” emerges from a study carried out in Japan. Researchers followed 3731 Japanese men and women aged 35 to 89 years from 1984 to 2001. Food intakes were determined from a 24-hour food diary at the beginning of the study. During the following 15 years, 60 deaths from cerebral infarction (stroke) occurred. A high intake of animal fat and cholesterol was significantly associated with a reduced risk of death from stroke (Stroke 2004;10:1161-01).
STATINS FOR MS?
With a view to expanding the market for one of the world’s most profitable classes of drugs—statin drugs for cholesterol lowering—scientists are now promoting them as a treatment for multiple sclerosis. In a recent clinical trial, MRI tests showed a decrease in the number and volume of new lesions in MS patients treated with statins (Lancet Neurol 2004 Jun;3(6):369-71). However, a member of the THINCS group (The International Network of Cholesterol Skeptics) reports that a colleague involved in multiple sclerosis research found little correlation between the severity of lesions as measured by MRI scans and neurological function in MS. The Lancet report makes no mention of this fact.
STATIN MADNESS. . .
In 2003, sales of statins totaled almost $14 billion, up 10.9 percent from 2002. Growth of this magnitude can only be achieved by rapidly expanding the customer base. First proposed for men deemed “at risk” for heart disease by virtue of “high” cholesterol levels, doctors now recommend statins for both men and women of all ages, especially targeting diabetics and sufferers of rheumatoid arthritis. The literature even promotes statin use as a cancer prevention measure. The cholesterol juggernaut is not daunted by cautionary studies, such as a review appearing in the May 12, 2004 issue of the Journal of the American Medical Association. The authors looked at studies going back almost 30 years and concluded that statin drugs do not provide any benefit to women who do not have already existing heart disease. More healthy Americans joined the ranks of patients in July with new recommendations to lower LDL-cholesterol (the so-called “bad” cholesterol) to less than 100, 30 points lower than previously recommended. The authors of the recommendations, which were published in the journal Circulation and endorsed by the National Heart Lung and Blood Institute, the American Heart Association and the American College of Cardiology, have made a living promoting pharmaceuticals, with most receiving honoraria from all the major drug producers, including Merck, Pfizer, Parke-Davis, AstraZeneca, Abbott, Dupont, Sankyo, Bayer and Bristol-Myers Squibb. The challenge for the statin makers is to convince everyone “qualified” to actually take the drugs—only about half of them do. One proposal calls for making statins available as an over-the-counter drug (already an option in the UK). Another, presented at a UK medical meeting by Dr. John Reckless (this is his real name!), calls for adding statins to tap water—like fluoride. (Actually some of the bestselling statins—Lipitor, Baycol, Crestor and Lescol—contain a fluoride compound.) “It would be a great way of protecting people from heart disease before it even starts,” says Dr. Reckless. What Reckless fails to mention is that statins pose a massive risk of severe, horrible birth defects if taken by pregnant women, defects more horrible than those caused by thalidomide. The list of statin-induced defects includes holoprosencephaly (defective septum separating lateral cerebral ventricles with cerebral dysfunction), atrial septal defect, aortic hypoplasia, neural-tube defects, duplication of spinal cord, spina bifida, left renal dysplasia, disorganized lumbosacral vertebra and deformities in the limbs. “We seem to be sleepwalking into what could be a major medical disaster,” writes Dr. Malcolm Kendrick. “Most people, and most doctors, are unaware—or don’t seem to care—that statins should never ever be taken by women of childbearing age. . . . Yet, when statins are available OTC it is absolutely certain that women of childbearing age will take them, knowing nothing of this risk. It is equally certain that a number of these women will become pregnant, and many of these pregnancies will result in horribly deformed children” (redflagsdaily.com, 6/18/2004).
. . . AND THE DIET TO GO WITH IT
Not content to make you depressed, weak, achy and forgetful with statins, the medical profession recommends a lowfat diet of processed foods so you’ll feel even worse. A WAPF member recently diagnosed with “high” cholesterol shared with us the handouts his doctor gave him and it’s the same old, same old—margarine instead of butter, skim milk, nondairy creamer, lowfat milk and cheese, lean meat, skinless chicken breasts, egg substitutes, liquid vegetables oils and lowfat baked goods. No bacon, liver, sausage, cream, full-fat cheeses or coconut but high-sugar items like sherbert, angel food cake, lowfat jelly beans and hard candy are OK. In an editorial, Dean Ornish, dean of the ultra-lowfat diet, even argues that Medicare should reimburse dieticians who counsel heart patients on how to follow this spartan regime (Washington Post, August 8, 2004). Invoking “powerful benefits” including “sustained weight loss, improved sexual function, increased energy, decreased blood pressure, dramatic reductions in angina and better control of diabetes,” Ornish promises that a diet of ersatz, tasteless food will increase your “joy of living,” providing far more motivation than the “fear of dying.” Here’s what we’d like to know: Even if such a diet were effective (which it is not), how many measley days would such soul-numbing measures add to the human carcass?
We have often described how proponents of the cholesterol theory of heart disease deal with contradictory evidence—not by chucking the whole thing in the garbage where it belongs but by assigning it to the category of paradox. An “American paradox” has emerged from a study published in the American Journal of Clinical Nutrition (2004;80:1175-84). Using coronary angiography, researchers looked at the progression of buildup in the arteries in 235 postmenopausal women with established coronary heart disease. They found that a greater saturated fat intake was associated with less progression of coronary atherosclerosis, whereas carbohydrate intake was associated with more progression. But don’t look for these startling findings to be reflected in government dietary policy anytime soon; an editorial in the same issue explains away the politically incorrect test results with all sorts of statistical mumbo jumbo.
MORE STATIN PROBLEMS
A new look at the effects of statin drugs on cognitive function should give pause to anyone thinking of taking them. Researchers tested the learning ability of patients taking a low dose of simvastatin compared to controls (Am J Med 2004 Dec 1;117(11):823-9). Using tests called Elithorn Mazes, researchers looked at the level of improvement when patients take the test several times. The time for solving a puzzle of some kind was improved by 16 percent in the control group whereas the statin group showed no improvement. The difference, together the differences in a few other tests, was highly significant, meaning that a considerable number of statin-takers were unable to learn anything from the first test. The researchers tried to explain away the results by stating that “The observed treatment effects were quantitatively small and were primarily manifest not as an absolute decline in performance but as a failure to improve upon repeat posttreatment testing.” In a THINCS group report, Dr. Uffe Ravnskov describes the results somewhat differently: “Consider that this result was achieved in a study comparing only 189 statin-treated patients with 94 controls after only six months and on the lowest simvastatin dose used in clinical practice. Translated to the US population, it means that millions of people may have become unable to learn from previous experiences due to their cholesterol-lowering treatment.”
OUR FRIEND CHOLESTEROL
If your doctor is pressuring you to take drugs or stop eating butter in order to lower your cholesterol, be sure to tell him or her about the study that appeared in the February 2005 Journal of the American Geriatrics Society (Vol 53, pages 219-226). Researchers evaluated 2277 senior Americans, aged 65 to 98, 21 percent of whom were taking cholesterol-lowering drugs. Over a period of three years, lower total cholesterol and lower LDL-cholesterol (the so-called “bad” cholesterol) were associated with a greater risk of dying. Use of cholesterol-lowering drugs seemed to lower this association, but did not abolish the elevated risk of death. This study confirms a similar finding from the Honolulu Heart Program, where those who had low levels of cholesterol over 20 years had a higher risk of dying from all causes (Lancet 2001;358:351-55). And if your pediatrician is pressuring you to lower your child’s cholesterol by denying traditional foods like eggs, butter and whole milk, be sure to tell him or her about a study published April 1, 2005, in the American Journal of Epidemiology (Vol 161, No 1, pages 691-699). Investigators looked at cholesterol levels and psychosocial development in 4,852 children, ages 6 to 16 years. Non-African-American children with low cholesterol (less than 145 mg/dl) were almost three times more likely to have been suspended or expelled from schools than those who had higher cholesterol levels. The authors concluded that low total cholesterol “may be a risk factor for aggression.”
DEATH BY MARGARINE
In Holland, people with “high” cholesterol or one of the 588 other risk factors for heart disease get a prescription for a cholesterol-lowering drug and advice to buy Unilever’s Becel Pro Aktiv, a margarine containing cholesterol-lowering plant sterols. Nurses offer cholesterol tests in the supermarket next to the margarine shelves while the Dutch heart association promotes Becel with scaremongering TV commercials. This is a fairytale deal between Uniliver, the Dutch heart association and Dutch health insurers (who pay for the margarine!), one that could well happen in the US. In a letter to Dr. Uffe Ravnskov’s THINCS group, W. M. Nimal Ratnayake, PhD, of Health Canada explains just why plant sterols are so dangerous. Stroke-prone rats fed sterols hyperabsorb these compounds leading to increased rigidity of red blood cells and drastically reduced life span. Humans prone to hemorrhagic stroke have similar abnormalities in the red blood cells (Clin Exp Hypertension 1980;2:1009-1021). Furthermore, hemorrhagic stroke occurs at higher rates in persons with low levels of cholesterol (Irbarren, JAMA, 1995).
Scientists have discovered a novel role for cholesterol, one that explains why low cholesterol is linked to cancer and many other diseases. Cholesterol in cell membranes appears to anchor a signaling pathway linked to cell division and cancer. “Cell signals have to be tightly controlled,” says Dr. Richard GW Anderson, chairman of cell biology at UT Southwestern Medical Center and head of the study. “If the signaling machines do not work, which can happen when the cell doesn’t have enough cholesterol, the cell gets the wrong information, and disease results.” Every cell in our body is surrounded by a membrane composed of fatty acids and containing cholesterol. The cholesterol-containing regions of the cell membrane are more rigid than the other areas and play a critical role in organizing signaling machinery at the cell surface. The correct arrangement of signaling modules in these domains is vital for communication inside the cell and is dependent on proper levels of cholesterol (Science, March 4, 2005).
In yet another example of hyped results, researchers have announced that “intensive lipid lowering [with a statin drug] beyond currently recommended levels provides significant additional clinical benefits in patients with coronary heart disease.” Citing the results of the Treating to New Targets (TNT) trial, Dr. John LaRosa, a tireless proponent of getting everybody’s cholesterol as low as possible, made the announcement at the American Cardiology’s annual scientific session, held in Orlando, Florida, March 2005. Dr. Eric Topol, who runs theheart.org, which is funded by AstraZeneca, a maker of cholesterol-lowering drugs, was even more emphatic: “There isn’t any question left at this point that we should be more aggressive.” However, a cold look at the study results reveals nothing to crow about. Researchers followed 10,000 patients who were given either a low or high dose of the popular cholesterol-lowering drug Lipitor. Total mortality was identical in the two groups—5.6 percent in the low-dose group and 5.7 percent in the high-dose group. The high-dose group had slightly lower mortality from coronary heart disease but higher mortality from other causes (N Engl J Med 2004;350:1495-504). LaRosa dismissed the higher levels of non-cardiovascular mortality in the high-dose group—as well as several cases of reported side effects—as an artifact due to chance and suggested altering the current cholesterol recommendation to one that calls for even more aggressive lipid lowering. One independent commentator has suggested that TNT refers to Twisting Natural Truths!
Researchers are scratching their collective heads over recent findings that cast doubt on the widespread use of cholesterol-lowering drugs. The first was published in the May 24 issue of the journal Neurology. Scientists in Sweden analyzed data from 392 men and women in Goteborg, Sweden over an 18-year period. They found that high total cholesterol at ages 70, 75 and 79 was associated with a reduced risk of dementia between ages 79 and 88. What this means is that we need to keep our cholesterol levels high if we want to have keen minds well into old age. But scientists wedded to the cholesterol theory dare not make so bold a statement. Instead, they weasel-word. “These findings raise more questions than they give answers,” says Michelle M. Mielke of the Center on Aging and Health at Johns Hopkins Bloomberg School of Public Health and one of the study authors. “Therefore, we strongly urge that consumers not make changes in their diet or medication without consulting with their doctors first.” Rachel Whitmer, a research scientist specializing in cognitive aging at Kaiser Permanente Northern California also specializes in saying nothing with a lot of words: “Lingering questions were not put to rest, but new exciting ones are raised. . . . This study is another example of the importance of timing in terms of when one measures a risk factor, and the need to consider risk factors for dementia over the entire life course.” A second study, which was a follow-up of the Framingham Heart Study and published in Psychosomatic Medicine (2005;67:24-30), found that lower naturally occurring total cholesterol levels are associated with poorer performance on cognitive measures such as abstract reasoning, attention/concentration, word fluency and executive functioning. Once again, double talk was necessary: “. . . competing risks must always be taken into consideration,” said the researchers. “Lower cholesterol values may have modestly detrimental effects on cognitive function for the individual but, depending on the patient’s risk profile, may have beneficial effects with respect to cardiovascular morbidity and mortality.” Rather than risk dementia in the elderly (and not so elderly) by force-feeding statin drugs, the medical profession needs to admit that the whole theory is demented.
RECIPE FOR DISASTER
The American Heart Association and the American Academy of Pediatrics have ganged up to target children with a starvation diet guaranteed to saddle them with health and behavioral problems as they enter adulthood (Reuters Health 9/28/2005). Clothed in platitudes—“breast feed through the first year,” “skip calorie-packed, low-nutrient foods, “delay introducing juice until at least 6 months of age”—the new guidelines dictate withholding foods that growing children need most, namely animal fats and salt. Parents are advised to feed them lean meats, skinless chicken, “low-mercury” fish and fat-free milk. In this scheme, children don’t even get the small amount of fat in lowfat milk—it must be fat free! And they don’t get butter either, but vegetable oils and soft margarine. Plenty of whole grains (including extruded whole grain breakfast cereals) mean lots of stress on the developing intestinal tract and salt restriction guarantees suboptimal intellectual development. The phrase that comes to mind as one contemplates the consequences of this appalling advice is “wailing and gnashing of teeth.”
Consumers have filed the first-of-its-kind, nationwide class action lawsuit against Pfizer, maker of the popular cholesterol-lowering, statin drug Lipitor. The lawsuit alleges that Pfizer engaged in a massive campaign to convince both doctors and patients that Lipitor is a beneficial treatment for nearly everyone with elevated cholesterol, even though no studies have shown it to be effective for those over 65, and for women at any age who do not already have heart disease or diabetes. In fact, the ASCOT study, the largest clinical trial on the effectiveness of statin therapy in women, found that women at increased risk of developing heart disease who took Lipitor developed 10 percent more heart attacks than the women who took the placebo. The proposed class action seeks to represent women who have taken Lipitor and who have no history of heart disease or diabetes; people aged 65 and over who have taken Lipitor and who have no history of heart disease or diabetes; and third-party payers such as insurance companies, union health and welfare funds, self-insured employers and others who paid for Lipitor for patients in either of these two groups. The law suit was filed in US District Court in Boston by Steve Berman, managing partner of Hagens Berman Sobol Shapiro on behalf of several individuals, Health Care of All and the Teamsters. For further information see www.hbsslaw.com.
WINTER 2005-SPRING 2006
The slide into madness that started with the anti-saturated-fat agenda reached its lowest point in December when the Illinois State Board of Education proposed rules that would ban whole milk from school lunches (Associated Press, December 10, 2005). Under the new rules, cartons of whole milk, which have a high fat content, would be considered junk food, but baked Cheetos and one-ounce bags of baked potato chips would not. Whole milk flunks three of the major guidelines now used to assess whether a food is healthy or not: calories from fat exceeding 35 percent (except for nuts and seeds), calories from saturated fat exceeding 10 percent and total calories exceeding 200 for an individual package. Of course, whole milk could be packaged in tiny cartons, like the baked potato chips, but the crazy logic that allows junk food in small packages does not seem to apply to real foods like whole milk. Besides, the dairy industry makes more profit on skim milk (because they can sell the butterfat separately in high-value foods like ice cream) and sugar-laden chocolate milk—which school children are now consuming by the gallon.
Now that the cholesterol-lowering drugs called statins have become the treatment of choice for heart disease, scientists are looking at just how much they can lower levels of LDL cholesterol (the so-called “bad” cholesterol) without actually killing the patient with the treatment. The Treating to New Targets (TNT) Study, published in 2004, found that high doses of statins improved cardiovascular disease outcomes slightly but resulted in higher numbers of deaths from other causes. In the Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) study, published in the November 16, 2005 issue of the Journal of the American Medical Association (JAMA), researchers did not even find a benefit for cardiovascular disease from aggressive cholesterol lowering, although they were able to tease “reduced risk when certain secondary outcomes (composite end points of any coronary heart disease event)” from the data, In an editorial on the IDEAL trial, published in the same issue of JAMA, Dr. Christopher Cannon repeats the dogma that for LDL-cholesterol, “lower is better for preventing MI stroke, need for cardiac procedures and death,” but hints at problems with the study when he calls for careful monitoring of “adverse effects” and even pursuit of “new avenues of treatment.” That’s because total mortality was higher in the high-dose statin group and, of even more concern, almost all of the participants reported some kind of side effect from the treatment—with almost half of the participants in each group suffering a serious adverse effect. Dr. Uffe Ravnskov points out other flaws in the study: only 20 percent of the study group was female in order to conceal the bad effects of statins on women; fully 79 percent of the subjects took aspirin, a serious confounder; the authors used the criteria of relative risk to exaggerate any marginal benefits; and, finally, the authors did not address current research indicating that low LDL-cholesterol is actually a risk factor for heart disease and that LDL lowering can be detrimental. It all points to the fact that cholesterol lowering as a treatment for heart disease is less than ideal.
Pfizer will have trouble meeting its marketing objectives this year as sales of its popular cholesterol-lowering drug Lipitor have fallen “significantly short of expectation.” Pfizer had hoped to increase Lipitor sales by 7 percent in 2006; instead sales declined 3 percent in the first quarter. Financial analysts blame competition from other cholesterol-lowering drugs and generic versions of these statins now coming on the market. According to Hank McKinnel, chairman and chief executive of Pfizer, the company is counting on “powerful clinical data and new educational campaigns on [Lipitor’s] health benefits” (Financial Times, April 20, 2006). In other words, expect to see more phony science and heavy advertising to promote this dangerous and unnecessary drug, even to groups for whom clinical data has shown no benefit whatsoever—women, the elderly. . . and children.
STARTING WITH THE YOUNG
Yes, children are now a target of lipid-lowering campaigns. A study published in the New England Journal of Medicine (March 23, 2006), which found fewer “coronary events” in young blacks genetically predisposed to have lower LDL cholesterol levels, has led to renewed calls for cholesterol lowering in young people. “The new findings suggest the need to redouble our efforts to reduce LDL-cholesterol levels in younger persons by promoting healthy diets and reducing obesity,” wrote Alan R. Tall of Columbia University Medical Center. “Even small successes will probably be leveraged for later gains in lowering the risk of cardiovascular disease.” Dr. Scott Grundy, an unabashed apologist for the lipid hypothesis, went further: In addition to restricting cholesterol and saturated fat, he argues that “[i]n some people it may be necessary to add drugs to reduce cholesterol levels.” These lowfat and statin proponents seem oblivious to research showing the downside of low cholesterol levels in young people. For example, a study published in the American Journal of Epidemiology (161(7):691-99, 2005) found that non-African-American children with cholesterol concentrations below the 25th percentile were nearly three times as likely to have been suspended or expelled from school as those with total cholesterol levels at or above the 25th percentile. Among many roles in the body chemistry, cholesterol is necessary for neurological development, for the proper function of serotonin and other “feel-good” chemicals, and for the production of sex and stress hormones.
Falling sales may be giving Pfizer executives nightmares because cholesterol-lowering drugs are giving nightmares to the people taking them. A recent report published in the British Journal of Medicine (April 21, 2006) describes a 72-year-old woman who experienced extreme nightmares after beginning “treatment” for “hypercholesterolemia” with Lipitor. When she discontinued the drug the nightmares ceased, and when she agreed to a rechallenge with Lipitor, the nightmares occurred again. The problem was solved by going off Lipitor for good. The author of the report speculates that the nightmares could be a direct effect of the statin on the central nervous system and notes previous reports of nightmares associated with other cholesterol-lowering drugs.
More bad news for Pfizer includes a doubling of heart failure rates since statins were introduced (Circulation, February 6, 2006). A new study of older men and women shows that higher LDL-cholesterol levels are associated with decreasing mortality risk in women. For both men and women, the risk of fatal heart failure decreases with higher LDL-cholesterol levels (Journal of the American Geriatric Society, December 2005).
Go to http://www.askapatient.com and click on ratings and then Lipitor, where you will find almost 700 comments on the cholesterol-lowering drug. What is interesting is the very high number of patients reporting side effects, including severe fatigue, joint pain, digestive problems, craving for fatty foods, difficulty breathing, thinning hair, depression, lack of concentration, memory lapses, thoughts of suicide, nightmares, peripheral neuropathy, paralysis, dizziness, painful charley horses, weight gain, blurred vision, headaches, insomnia, difficulty walking, rashes, blisters, slurred speech, eczema and “itching all over.” Yet most of the ratings are positive, with patients expressing satisfaction at bringing their cholesterol levels down, and persevering in spite of the debilitating side effects. Such is the level of cholesterol anxiety engendered by the phony lipid hypothesis. Perhaps “complete decline in the power of reason” should be added to the list of side effects from cholesterol-lowering drugs.
LACK OF EVIDENCE
Recent national recommendations suggest that physicians should use drugs to achieve LDL-cholesterol levels of less than 70 for patients at “very high cardiovascular risk” and less than 100 for patients at “high cardiovascular risk.” In a recent review of all controlled trials, cohort studies and case-control studies that examined the independent relationship between LDL-cholesterol and major cardiovascular outcomes in patients with LDL levels less than 130, researchers were surprised to find no evidence to suggest “that the degree to which LDL-cholesterol responds to a statin independently predicts the degree of cardiovascular risk reduction” (Annals of Internal Medicine, October 3, 2006). In other words, using statin drugs to get your LDL-cholesterol as low as possible does not reduce your risk of heart disease. But rather than question the whole business of cholesterol-lowering for lack of evidence, the research team concluded that “there are no intrinsic barriers to producing such evidence.” The strategy of lowering LDL-cholesterol by drugs is not a bad one, they say, only the studies that fail to support such a strategy are bad. Studies that eliminate conflicting variables and research bias might provide “valid evidence,” they claim, but in the meantime, treatment with statins should continue.
MORE LACK OF EVIDENCE
Another report published this year describes a Finnish study in which researchers enrolled 400 home-dwelling people between the ages of 75 and 90 years who suffered from cardiovascular disease. The patients were randomly assigned to receive either usual care from their primary care physician or specialized care based on “current evidence-based European guidelines for chronic CVD.” Over an average of 3.4 years, the group receiving “specialized care” had significantly higher use of drugs to lower blood pressure and cholesterol levels. However, the incidence of heart attack, heart failure, stroke and cardiovascular death were similar between the two groups, and deaths due to any cause also occurred at similar rates (18 percent versus 17 percent). Nor did the time until a first cardiovascular event differ between the two groups (American Heart Journal 2006;152:585-592). So why bother with the expense and aggravation of “specialized” care? The evidence for the aggressive use of drugs in the elderly is just not there—yet the elderly remain prime targets for the pharmaceutical industry.
Researchers presented the results of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) with a lot of fanfare at the 15th European Stroke Conference in Brussels, Belgium, in May, 2006 (theheart.org). The study enrolled 4731 patients who had suffered a recent stroke and assigned them to receive a strong cholesterol-lowering statin drug or a placebo. LDL-cholesterol fell by 38 percent in the statin group compared to 7 percent in the placebo group. Those treated with statins showed reductions in fatal and ischemic stroke, but experienced a significant increase in hemorrhagic stroke. When it came to overall deaths, the SPARCL Trial really fizzled—216 deaths among those taking statins versus 210 in the placebo group. So taking statins after a stroke increases your chances of dying by 3 percent. . . after several years of suffering from the effects of drastic cholesterol lowering. But the study report makes no mention of side effects. Apparently the researchers didn’t ask the participants how they felt. And then there are the costs to consider. Even defenders of using statins for stroke prevention note that based on SPARCL data, statin therapy costs $203,000 to prevent one stroke in five years (Stroke, online publication February 1, 2007).
DEMENTIA AND CHOLESTEROL
Manufacturers of statins and their cohorts in the media are blithely promoting these cholesterol-lowering drugs to ward off Alzheimer’s disease and dementia. A good example is a February 8, 2007 article appearing in the British paper The Daily Mail. The authors of “Diet high in cholesterol can trigger onset of Alzheimer’s” warn about studies showing that “eating lots of foods containing saturated fats, such as butter and red meat, can boost levels of proteins in the brain linked to dementia,” and that “large amounts of harmful cholesterol are found in foods high in saturated fats such as red meat, butter, cheese and offal such as liver and kidneys.” These dire warnings are not based on studies of humans eating red meat and butter—an online search for red meat or butter plus Alzheimer’s yields nothing—but are based on research in which rats are given large amounts of purified cholesterol. The article cites “…growing evidence that taking cholesterol-lowering statins makes people less likely to develop Alzheimer’s later in life.” No reference is provided for this remarkable statement, remarkable given the many published reports of statin-induced cognitive decline. More sobering news comes from the Honolulu-Asia Aging study. Researchers followed over 1000 Japanese-American men over a 40-year period, starting in 1965. They found that cholesterol levels in men with dementia and, in particular, those with Alzheimer’s, had declined at least 15 years before the diagnosis and remained lower than cholesterol levels in men without dementia throughout that period. Their conclusion: “A decline in serum total cholesterol levels may be associated with early stages in the development of dementia” (Arch Neurol 64:103, 2007).
CHINKS IN THE STATIN DIKE
“Trends in mortality from coronary heart disease have not effectively changed since statins were approved in the United States. . .” This damning statement appeared in the International Journal of Cardiology, February 21, 2007. The authors state categorically that the “beatification” of statins as miracle drugs is not justified. “Changes in lifestyle should be considered the cornerstone of cardiovascular prevention. . . Adherence to healthful lifestyle has been shown to be associated with reductions in the rates of coronary disease, diabetes in women and mortality in elderly. Patients with major lifestyle problems enrolled in recent statin trials were given only drugs, and no statin has ever been compared with a non-atherogenic lifestyle and shown to be superior or additive.” The authors also note that studies on statin drugs minimize and under-report the side effects. Meanwhile in the Netherlands, a talk program called Radar has caused a furor in medical circles. The program zeroed in on statin side effects and included interviews with author Dr. Uffe Ravnskov and colleagues from The International Network of Cholesterol Skeptics (THINCS), who, on prime time TV, challenged the dogma that high cholesterol causes heart disease. According to the Dutch Cardiology Society, the program’s assertions have caused “great unrest among patients.” Wybren Jaarsma, chairman of the Society, writes that many colleagues have faced questions from patients over whether they should “continue care that has been scientifically shown to be effective and necessary. . . . You must continue taking prescribed cholesterol medication,” he declares. Establishment physicians have refused invitations to debate the subject on air. Instead, Dutch doctors are calling for restrictions on television programs that they claim “deliberately use matters of patient safety to boost viewing figures.” Such calls for censorship are a sure sign of a sinking ship.
THE STATIN SHUFFLE
While the pill-pushers continue to promote cholesterol-lowering with a vengeance—a recent article published in the American Heart Journal (2006:785-92) announced that clinicians are “under-prescribing” statin drugs—evidence accumulates that the little pill taken by 12 million Americans (a number the pharmaceutical industry would like to triple) may be bad news for a lot of people in a lot of ways. One recent study found that statin treatment caused a deterioration of blood sugar control in diabetics (Atheroscler Thromb 2006 Apr;13(2):95-100). Another reports that statin-induced cholesterol lowering causes muscular damage even when the patient has no symptoms of pain or weakness (J Pathol 2006 210(1):94-102). Another found elevated risk of lymphoid malignancy with statin use among Japanese patients (Cancer Sci 2006;97:133-138). Yet another presents evidence that statins interfere with selenium pathways (Lancet 363:892-94, 2004). Very low cholesterol is associated with poor survival in heart failure patents (American Journal of Cardiology, September 2006), a finding the study author called “counter intuitive.” Most serious is accumulating evidence that cholesterol-lowering is bad for our brains. One new study indicates that a decline in total cholesterol levels precedes the diagnosis of dementia by at least fifteen years (Archives of Neurology 2007;64:103-107). Evidence that low levels of LDL-cholesterol are associated with Parkinson’s disease have become so strong that a team at the University of North Carolina is planning to explore the link with clinical trials involving thousands of subjects (Reuters, January 15, 2007). Cholesterol circulating in the bloodstream is unavailable to the brain—both LDL and HDL are too large to pass the blood-brain barrier, so cholesterol needed by the brain must be manufactured in the brain. Statins, however, do pass the barrier and enter the brain where they can interfere with cholesterol production and set the scene for cognitive decline.