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Do Cholesterol-Lowering Drugs Benefit Women?

Posted by medconsumers on June 1, 2004

Many doctors have come to believe that the cholesterol-lowering drugs called statins (Lipitor, Zocor, Pravachol, Mevacor, Crestor) are safer than low-dose daily aspirin. That becomes apparent whenever statins are featured in the media as a wonder drug for the prevention of heart disease. In fact, there’s a growing consensus among cardiologists that all adults should take a statin whether or not they are at high risk.

Yet women have been underrepresented in the major clinical trials in which people with and without heart disease were randomly assigned to take a statin or a placebo (dummy pill) every day for several years. Women made up less than one-third of all the study participants. Put that together with the fact that women under the age of 75 years have a low rate of heart attack and stroke. Add this disturbing bit of news from University of British Columbia researchers who conducted a thorough review of the five prevention clinical trials: only two of the five trials released their data regarding the serious adverse effects* suffered by the study participants who were taking statins. Working with what they had, that is, the data from only two of the statin trials, the researchers found that statins did not prolong life for men or women. Worse, the benefit of taking statins (a reduced rate of non-fatal heart attacks and stroke) was offset by an increase in the serious adverse events. Until all the statin trials release their serious adverse effects data, the public will not know whether these drugs are safer than low-dose aspirin.

The sparse information that people receive about cholesterol treatment was unintentionally but aptly illustrated recently by one of the country’s top medical journals. The Journal of the American Medical Association, or JAMA, regularly publishes a “patient page,” which amounts to a layman’s translation of one of the more important papers published in each issue.

The May 12, 2004 issue of JAMA contained a review of all trials in which women with high cholesterol had been randomly assigned to take a drug or a placebo. (Most of the trials involved a statin.) Judith M.E. Walsh, MD, MPH, and Michael Pignone , MD, MPH conducted the review. Their conclusion: For women without heart disease, drugs did not prolong life or reduce the odds of dying of heart disease. The drug may reduce non-fatal cardiac events (heart attack, stroke, etc.), but “current evidence is insufficient to determine this conclusively.” For women with heart disease, drugs do not affect mortality but will reduce non-fatal events.

Turn to the patient page in the same issue of JAMA, and none of this important information can be found. Instead, six sentences are devoted to statins explaining how they work; the need for regular lab tests to check for statin-induced liver damage; the possibility of muscle damage, etc. The reader will find nothing about the drugs’ effectiveness (or ineffectiveness) in preventing or treating heart disease. The rest of the page was given over to the usual information about exercise and smoking cessation. Worse, it has outdated information about the importance of a low-fat diet; despite the fact that a review of all relevant studies found that it has little effect on heart disease prevention (see below). The patient page is intended for physicians to photocopy and give to their patients.

And what about the unreported serious adverse effects of statin drugs? Not a mention in the patient page, of course, but there it was in the “comments” section of the JAMA article. At the end of their review, Drs. Walsh and Pignone discuss possible explanations for why statins do not prolong life for women with heart disease. The drugs reduce the odds of dying of heart disease, but that benefit is canceled by a higher rate of death from other causes.

“Possible explanations include chance, the limitation that not all studies reported both heart disease and total mortality… Another potential explanation might be an increase in a competing cause of mortality, for example, an increase in hemorrhagic stroke with cholesterol-lowering therapy. However, information on the causes of non-heart disease mortality is not available for all the trials, so this possibility cannot be proven. [emphasis added] Publication of cause-specific mortality for many of the larger trials could help to clarify the association between cholesterol-lowering therapy and total mortality.”

There you have it, the full story is not yet available on the safety of cholesterol-lowering drugs, though these trials were published years ago. Traditionally, researchers design trials to answer specific questions. In this case: Does this drug reduce the rate of heart attacks and strokes or the rate of cardiovascular death? But the drug itself might cause deaths from other causes, and as Drs. Walsh and Pignone wrote, not all studies reported deaths from other causes. These concerns are relevant to men, as well.

As for the doctors who say that statins are safer than aspirin, they might one day be proven correct. But it took more than 100 years to get the full story on aspirin. (In fact, there might be more to learn.) Gastrointestinal bleeding and rarely, hemorrhagic stroke are both potentially fatal side effects of chronic use of aspirin, even at low doses. And the dangers of giving aspirin to children who have flu or chicken pox have only been known to be associated with the rare risk of Reye’s syndrome for less than 30 years.

*Serious adverse effects are any untoward medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, or results in persistent or significant liability.

Maryann Napoli, Center for Medical Consumers (C)

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Cardiologists Poised to Give Everyone Lipitor

Posted by medconsumers on April 1, 2004

The findings were considered to be so important that The New England Journal of Medicine made the study freely available on its Web site one month earlier than the April 8 publication date. Two cholesterol-lowering statin drugs—Lipitor (atorvastatin) and Pravachol (pravastatin)—were compared in a clinical trial that involved 4,162 people who had been hospitalized for a sudden attack of chest pain due to heart disease. Lipitor proved to be more effective at reducing the rate of deaths from heart disease, heart-related problems and the need for procedures, such as bypass surgery and angioplasty. Once the news caught media attention, the reporting made the benefit appear larger than it is.

Some of the participants, all of whom had heart disease and low levels of LDL, the so-called bad cholesterol, benefited from even further reductions in their LDL with Lipitor. The finding is widely expected to lead to a lowering of what constitutes the ideal level of LDL. Currently, people are told to keep their LDL below 100 mg.

The participants had been randomly assigned to take either a higher than normal dose of Lipitor (80 mg) or the standard 40 mg dose of Pravachol each day. Because of the high stakes, drug companies rarely pit their drug against a competitor in a clinical trial. Bristol-Myers Squibb, maker of Pravachol, lost big time by sponsoring this trial. It was designed to prove that Pravachol, which had been losing market share, is just as good as the more costly high dose Lipitor.

At the time this trial was planned, Pravachol’s highest dose was 40 mg. The study is known by the catchy name of Prove It, or Pravastatin or Atorvastatin Evaluation and Infection Therapy.

Here are the differences in outcomes in the Prove It trial: After two years, the people on Pravachol had a combined rate of heart attack, bypass surgery, angioplasty, stroke and death of 26.3% compared with 22.4% for people on Lipitor. The death rate from heart disease was 1.1% for the Lipitor group compared to 1.4% for the Pravachol group. The rate of death from any cause was 2.2% for people on Lipitor and 3.2% for people on Pravachol.

These 1- 3% differences in favor of Lipitor have cardiologists across the country quite excited and ready to raise the statin dose and lower the threshold for safe LDL levels. The Prove It results would be exciting if we had the full picture on high-dose Lipitor. As is often the case, the serious adverse effects experienced by the study participants taking Lipitor were not reported.

Christopher P. Cannon, MD, who led the Prove It trial, was asked about this information gap. “We do plan a separate full publication of all the safety data soon…the journal only allows a certain amount of space for only one paper,” he responded by e-mail. “There were more liver function test abnormalities with Lipitor at 80 mg, but these were all transient and were resolved when the dose was stopped or reduced.” Still, adverse reactions caused nearly one out of every three participants to stop the drug. 3% more people in the Lipitor group stopped taking the drug. Besides liver failure, muscle pain is a known consequence of high-dose statin therapy.

Dr. Cannon said that his study found Lipitor to be better than Pravachol for both men and women, though women represented only 22% of the participants (911). The above-quoted statistics apply to all participants, and the researcher did not break things down to show how large the benefits are to women, or whether they have a higher rate of serious adverse reactions.

90% of participants were white and the rest were not specified. This leaves an information gap for everyone else. Earlier studies have shown that Asians, for example, are at a higher risk for severe muscle damage if they take any statin at daily doses of 80 mg. For unknown reasons, the drug tends to remain in the body longer in Asians, which raises their odds of this and other adverse effects. Dr. Cannon and colleagues suggest that their findings point to the need for 62 mg as the new LDL threshold for people with “established coronary heart disease.”

Judging from the media reports of Prove It trial, many cardiologists seem poised to extend its results to people without heart disease. None of the physicians quoted in the media warned that this would amount to a dangerous experiment. In all the previous clinical trials that involved people without heart disease, statin drugs were administered in doses no higher than 40 mg. Only one prevention trial involved people taking Lipitor. None lasted more than seven years.

Interestingly, the new results have revived an old controversy about whether the benefits of statins are due to their cholesterol lowering, anti-inflammatory or some other effects. “Unfortunately, we do not know the precise mechanism of action responsible for atorvastatin’s [Lipitor's] superiority,” wrote Eric J. Topol, MD, of the Cleveland Clinic in an accompanying editorial. Dr. Topol believes that “only a fraction of the patients who should be treated with a statin are actually receiving such therapy.” He sees cost as the biggest stumbling block. Lipitor, at the recommended starting dose of 10 mg, is about $900 per year. At the 80-mg dose used in the Prove It trial, Lipitor costs about $1,400 per year.

What you can do
Here are several non-drug ways to reduce your odds of having a heart attack.

  • Cut trans fatty acids from your diet because they have long been known to be damaging to the heart. Trans fatty acids are formed during the hydrogenation of either vegetable or fish oils. They are used extensively in processed foods to ensure a longer shelf life. Certain foods like donuts, potato chips and other snack foods are particularly high in trans fatty acids. Look for the words “partially hydrogenated oil” or “shortening” on the ingredients list.
  • Take niacin supplements. The Coronary Drug Project followed 3,908 men taking a placebo or niacin therapy for nine years. The niacin group had a lower rate of non-fatal heart attacks and an 11% lower rate of all-cause mortality than the men in the placebo group. A recent survey of the various types of niacin on the market found that immediate-release niacin is the least expensive and safest version to purchase (and the no-flush niacin products are useless, see HealthFacts January 2004).
  • Add heart healthy foods with omega-3 fatty acids and folic acid to your diet. Omega-3 fats can be found in fish, omega-3-enriched eggs, walnuts and flax seeds. Folic acid is in green vegetables, beans, wheat germ and certain fruits and vegetables.

Maryann Napoli, April 2004

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Niacin Supplements for Cholestrol-Reduction: Not All Brands are Equal… and Some are Dangerous

Posted by medconsumers on January 1, 2004

by Maryann Napoli

Many people take over-the-counter niacin as a replacement for, or complement to, cholesterol-lowering drugs. A new survey shows that these products do not always contain the amount of niacin, or nicotinic acid (vitamin B 3 ) described on the label. The survey found broad variations in the products, ranging from no available niacin to toxic levels of niacin. The inconsistencies are attributed to the fact that niacin is classified by the FDA as a dietary supplement. This means that the product is entirely unregulated; therefore, the manufacturers do not have to prove quality, safety, or efficacy.

The survey of niacin products was conducted by C. Daniel Meyers, MD, Veterans Affairs Medical Center, Long Beach, CA, and colleagues, who acknowledged that niacin is one of the first agents found to raise the level of good cholesterol (HDL) and lower the level of bad cholesterol (LDL) and triglycerides when taken in daily doses of 1,000-4,000 mg. The worst side effect is “niacin flushing,” that is, redness, itching, burning, which starts within 10-15 minutes after swallowing the tablet and can last up to an hour.

Dr. Meyers and colleagues looked at 29 commonly used over-the-counter niacin products (500-mg tablets or capsules) from three categories: Immediate-release, sustained-release, and “no-flush.” They calculated the monthly cost for each product purchased in pharmacies, health-food stores or over the Internet. Ironically, the no-flush preparations, the most expensive ($21.70) of all, do not contain free* nicotinic acid. Some brands of the sustained-release preparations contain amounts of niacin so high as to be toxic to the liver.

In yet another ironic twist, the best products are the least expensive ($7.10). They are the immediate-release preparations, which contain, according to Dr. Meyers and colleagues, “the full amount of free nicotinic acid used safely for more than 40 years” and “shown to prevent cardiovascular disease and death.” The cheapest brands in this category are Rugby, Bartell’s, Natural Factors—all are under $5.19 for a one-month supply (Annals of Internal Medicine, 12/16/03). In most people, the niacin flushing becomes less pronounced with time, according to Dr. Meyers and colleagues, who wrote, “Both the frequency and severity of flushing episodes decrease with repeated doses…Some trials, however, show that 40% of the people stopped taking niacin because of this side effect.”

The biggest irony of all regarding niacin is the likelihood that it is safer and just as effective as statin drugs—for men, that is. In the introduction to this survey, Dr. Meyers and colleagues cite the Coronary Drug Project, which followed 3,908 men taking a placebo or niacin therapy. After nine years of follow-up, the men in the latter group had not only a lower rate of non-fatal heart attacks but also an 11% lower rate of all-cause mortality than the men in the placebo group. Statin drugs lower cholesterol and reduce the rate of non-fatal heart attacks in men, but they do not reduce the rate of cardiovascular or overall death (See Statin Drugs: How Safe? How Effective?).

*The full amount, as designated on the label.

January 2004

Posted in Diet & Exercise, Heart | Tagged: , | Comments Off

How We Came to Believe that the Low-Fat Diet is Good and Cholesterol is Bad

Posted by medconsumers on December 30, 2003

Despite decades of effort and many thousands of people randomized [into clinical trials], there is still only limited and inconclusive evidence of the effects of modification of total, saturated, monounsaturated, or polyunsaturated fats on cardiovascular morbidity and mortality.

Lee Hooper et al, British Medical Journal, March 31, 2001

Yes, the low-fat message is yet-another overrated bit of medical advice. Haven’t we been hearing for years that a low-fat diet will reduce your odds of dying of a heart attack? Yet those who assessed all the relevant studies (like the reviewers quoted above) have concluded that the evidence supporting the advice boils down to this: Eating a low-fat diet will not help you live longer, but it may slightly reduce the odds of having a non-fatal heart attack–if you are a man. 

You may wonder why we have been led to believe otherwise. It’s a long story that begins with the Korean War. Autopsies done on the young casualties, whose average age was 22 years, surprised physicians who saw early evidence of heart disease in 77% of them. Next came the Framingham Heart Study, which began in the early 1950s and followed over 5,000 healthy men and women. High blood levels of cholesterol emerged as a major risk factor for heart attack for young and middle-aged men, but not for women or the elderly. It was, however, only one of 240 risk factors identified by the Framingham Heart Study.

Though dietary cholesterol was the assumed culprit in the development of heart disease, this possibility was disproved early on, according to an historical account by Thomas J. Moore for his 1989 book, Heart Failure. Moore notes that the Framingham researchers singled out over 900 men and women to compare their blood levels of cholesterol with the amount of cholesterol in their diets. To their surprise, there was no relationship. As so often happens in other areas of medicine, opinions became fixed before definitive studies proved or disproved the hypothesis. And in this case, a medical consensus had already developed: Everyone should be concerned about the amount of cholesterol in their diets. In time, the public was told to increase intake of polyunsaturated fats (e.g., vegetable oils), reduce intake of saturated fats (e.g., meat and dairy products), and severely restrict dietary cholesterol (e.g., egg yolks, beef, pork). Total fat intake was to be kept under 30% of calories.

Many more studies confirmed the Framingham finding of an association between high blood levels of cholesterol and heart disease. It is, however, one thing to identify a factor that puts people at higher risk for heart attack–proving that a change in the risk factor will lower a person’s death rate is an entirely different matter. This was demonstrated by the failure of the Multiple Risk Factor Intervention Trial, sponsored by the National Heart, Lung, and Blood Institute. 

This ten-year, $115 million research project followed over 12,866 middle-aged healthy but high-risk men who were randomly assigned to one of two groups. The Special Intervention Group received intensive instruction on smoking cessation, reducing consumption of dietary cholesterol and saturated fats, the need for regular physical activity, and blood pressure reduction. The other half of the participants formed the Usual Care Group who received no encouragement to change their risk factors. At ten years, there was no difference between the two groups in overall death rate or in the heart disease death rate.

In three other major trials where diet was used to reduce cholesterol, the best that could be found was a barely significant reduction in non-fatal cardiovascular “events.” In cholesterol-lowering drug trials, the heart disease death rates went down among the drug-treated men, but the reduction was always offset by a higher rate of death from other causes. “All we are doing is changing what it says on the death certificate,” said researcher Dr. William C. Taylor. With several colleagues, Dr. Taylor had calculated that a lifelong program of cholesterol reduction adds about three days to three months to the life expectancy of a low-risk symptom-free adult (Annals of Internal Medicine, 4/87). 

Despite the lack of proof that lowering cholesterol in people without heart disease has a lifesaving benefit, the National Cholesterol Education Program began a nationwide “Know Your Numbers” campaign in 1987 to get all Americans to have their blood cholesterol measured regularly. In 1995, a landmark clinical trial proved for the first time that a cholesterol-lowering drug could prevent heart disease deaths in healthy but high-risk men without increasing their odds of dying of something else. The drug used in this study was from a new class of cholesterol-lowering medications called statins. Half the 6,000 middle-aged Scottish men in this trial were given pravastatin and half were given a placebo. Results showed a modest lifesaving benefit for the group taking pravastatin. At five years, there was a 3.2% heart disease death rate among the men on pravastatin (brand name: Pravachol) and a 4.1% heart disease death rate among the men on the placebo.

Several years later, another statin, lovastatin (Mevacor), became the first drug to benefit healthy men and women with normal or borderline levels of cholesterol. The heart attack rate in the placebo group was 5.4%, compared with 3.5% in the lovastatin-treated group. The overall death rate was the same for both groups. While these two trials appear to verify the benefits of lowering blood levels of cholesterol, a growing number of researchers see another explanation for the statins’ benefit. These drugs appear to have anti-coagulation, anti-inflammatory, and some other biological effects that protect the arteries. Many researchers believe that inflammation plays a role in heart attacks and some forms of stroke, but the exact mechanism is uncertain. The inflammatory theory could explain why half the heart attacks occur in people with normal cholesterol levels. 

As statin drugs move front and center in the heart attack prevention picture, the low-fat diet is now under attack because the lack of supporting evidence was brought to the public’s attention by Gary Taubes, first in a 2001 article for Science (“The Soft Science of Dietary Fat”) and later in a much-discussed 2002 article for The New York Times (“What If It’s All Been a Big Fat Lie?”).  

While researchers continue to work out the ways that heart attacks and stroke can be prevented, it should be noted that the death rates for both have been declining steadily since the late 1940s–well before Americans ever heard the low-fat, lower your cholesterol messages. The nation is experiencing an epidemic of obesity that some attribute to the low-fat message which drove people to consume more refined carbohydrates and to increase their total caloric intake. Still, the heart disease death rate has dropped dramatically in the last two decades, a period in which the nation’s fat intake dropped only a pitiful 6%. Better treatments are thought to be the reason. It could also be due to the increasing percentage of Americans entering the middle class, a trend that began after World War II. (High socioeconomic status is associated with a lower rate of premature heart disease death, especially for women.) Whatever the reason, it isn’t the low-fat diet, and it isn’t reduced intake of dietary cholesterol.

 Maryann Napoli, Center for Medical Consumers© 2003

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Statins Drugs: How Safe? How Effective?

Posted by medconsumers on November 1, 2003

(Almost) Everything You Need to Know About Statin Drugs

Though the first of the statins went on the market over 17 years ago, they unofficially reached miracle drug status last summer when these cholesterol-lowering medicines made the front cover of Newsweek. The magazine’s breathless coverage started with the inevitable anecdote about a middle-aged man who was unable to lower his total cholesterol level of 290 through diet and exercise alone.

Six months of trying, and his level dropped a mere 27 points, so his doctor put him on “one of the class of powerful cholesterol-lowering drugs,” Lipitor. “He knows he should try harder to eat right,” continued the Newsweek article, “but he also knows he doesn’t have to worry about cholesterol as long as he takes that little pill every day. ‘It’s better living through chemistry,’ he says. Or perhaps more to the point, longer living.”

Well, that just about sums up the current rosy view of statins. It is also indicative of the unrealistically optimistic, one-sided information consumers get about these drugs from their doctors, the media and drug industry advertising. Too often, people get little more than this from their doctors: “Your cholesterol is too high, take this drug.” Or, if pressed for more information, a doctor might say: “Take this drug, it will reduce your chances of dying from a heart attack.”

Statins are intended as a lifelong treatment. Any drug taken by a healthy person every day for the rest of his or her life should be backed with clear evidence from carefully conducted studies that the benefits outweigh the risks. Such studies should have included people just like you, be they older women whose only risk factor is high cholesterol or middle-aged men with high cholesterol and several other risk factors for heart disease.

A Critical Look is Needed
This article will address such questions as: Are statins safe and effective for everyone? What exactly have they been proven to do? Will they increase longevity, as the Newsweek article implies? It will also describe a new analysis of all statin studies, which contradicts the prevailing belief that these drugs are of great preventive benefit to most older people. You will learn that the case for statin therapy is stronger for people with heart disease and/or diabetes than it is for healthy people with high cholesterol and another risk factor or two.

When statins were first introduced, they were prescribed primarily to people with heart disease. In time, they became an appropriate prescription for all older people. Lest you think that’s an exaggeration, recall the news out of England in the summer of 2003, when a respected team of researchers proposed the “ polypill ” for all adults over the age of 55, with a statin as one of six chosen lifesaving components (along with aspirin, folic acid, and three anti-hypertensive drugs at half dose).

The polypill might not have caught on yet, but the idea that just about every middle-aged and older person is a candidate for statin therapy certainly has. In fact, you needn’t have high cholesterol to get a prescription. And for older women, statins have begun to replace postmenopausal hormones as the drug of choice to prevent heart disease.

Advertised Widely
One can hardly make it through the TV evening news without viewing at least one statin ad, usually conveying the idea that diet and exercise are not enough to lower cholesterol in most people. (True enough, but more on that later.) The most egregious statin ad, however, is Pfizer’s campaign in Canada where, ironically, it is against the law to advertise prescription drugs to consumers.

Pfizer Canada gets around the law by not mentioning the name of its drug (a familiar tactic used in the U.S. to circumvent the mandated requirement of describing side effects). In what is known as a “heart disease awareness” ad, Canadians are encouraged to ask their doctors for a cholesterol test. The ad shows the bare feet of a corpse on a morgue drawer with a toe tag that reads: Male, age 42; cause of death: heart attack. The ad’s headline: “What would you rather have, a cholesterol test or a final exam?”

Six statin drugs are now available: atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor) and simvastatin (Zocor). Altogether statins drive a $20 billion a year world-wide market, with Lipitor No. 1– of all prescription drugs–in retail sales in the U.S. No head-to-head comparison has ever been conducted to determine whether one is superior to the others.

Statins are widely regarded as safe, and perhaps the safest of all cholesterol-lowering drugs, though no one has done a study comparing them against their older counterparts. The acknowledged side effects of statins include muscle pain and weakness, suppression of the body’s formation of Co-enzyme Q10 and, rarely, a potentially fatal muscle-wasting disorder called rhabdomyolysis. One statin, Baycol, has been withdrawn because it was linked to 31 deaths from rhabdomyolysis. The other statins still pose a rare risk for this disorder, especially at doses of 80 mg/daily. Another rare side effect is peripheral neuropathy, which is nerve damage that causes numbness or tingling in the hands and feet. Chief among the unacknowledged side effects are memory loss and other cognitive problems, which have been reported anecdotally by people who were not in clinical trials.

There is a controversy among researchers over the very real possibility that the benefit of statins has less to do with cholesterol reduction than the drugs’ other biochemical effects, most notably anti-inflammatory properties. Atherosclerosis is thought to be due to an inflammatory response to arterial injury–an injury caused by high blood pressure, smoking or other risk factors.

Cholesterol as a Disease:
To understand today’s obsession with cholesterol, it helps to have a little background regarding this particular risk factor and how it came to be treated as if it were a disease. High blood levels of cholesterol emerged as a risk factor for heart disease in the Framingham Heart Study, whose results have been misrepresented, according to some researchers. Begun in 1948, it followed 5,000 healthy men and women living in Framingham, Massachusetts, to determine which factors distinguished those who eventually suffered a heart attack.

Cholesterol was identified as one, but only one of 240 risk factors that included short stature, male baldness, creased ear lobes, and being married to a highly educated woman. Research focused on cholesterol because it is a modifiable risk factor (translation: drug industry opportunity). Though the Framingham Study found a strong association between blood levels of cholesterol and heart disease only in young and middle-aged men, the entire population was, in time, instructed to fear this particular risk factor.

Contrary to conventional medical wisdom, the Framingham study did not find that a high-fat diet doomed people to a heart attack. A subgroup of Framingham participants was assessed for their intake of saturated fats, dietary cholesterol and overall calories. None had any effect on the development of heart disease.

The idea that a low-fat diet prevents heart disease lives on, despite a 2001 review of all relevant clinical trials. The combined results showed that reducing or modifying dietary fat intake had no effect on heart disease mortality or total mortality (Hooper et al. British Medical Journal, 3/31/01).

However, modest reductions in non-fatal cardiovascular “events” (e.g., strokes, heart attacks) were shown in the few trials in which the participants remained on the diet for more than two years.

Several books have been written about the overrated importance of cholesterol (both dietary and blood levels) in the development of heart disease, most notably Heart Failure (1989) by Thomas J. Moore, The Cholesterol Myths (2000) by Uffe Ravnskov , MD, PhD, and Tales from the Other Drug Wars (1999: Chapter on Lipid-Lowering Drugs by Isabelle Savoie www.chspr.ubc.ca/misc/drugwars2.pdf) Such skeptics are usually fond of pointing out that half of all heart attacks occur in people who have normal cholesterol levels.

Lifestyle Changes Often have Small Effect
Once a person’s blood test shows high cholesterol, a low-fat diet is recommended, along with the admonition to get regular exercise. Most people will find that these two lifestyle changes bring only minimal reductions in cholesterol, making statin therapy the inevitable next step.

Given the emphasis on cholesterol “numbers,” it is easy to lose sight of the fact that the ultimate goal of drug therapy is not to lower cholesterol but to reduce the odds of dying of a heart attack or stroke. A pharmaceutical company seeking approval from the FDA, however, need only prove its drug can lower cholesterol. The more important, long-term studies are initiated many years later.

When researchers began conducting clinical trials to prove that lowering cholesterol will prevent cardiac deaths, they ran into some major snags over the course of several decades. Despite millions of dollars spent on clinical trials, researchers simply could not prove that lowering people’s cholesterol had any effect on life expectancy. Whether the study participants lowered their cholesterol with diet, exercise, smoking cessation, and/or drugs, the heart disease death rate went down but the over-all death rate, that is, the death rate from all causes, went up. In other words, their total death rate was no different from that of the people who did not lower their cholesterol.

Statins are Different…or are They?
Proof that statin drugs can benefit people without heart disease comes from five clinical trials in which the participants had been randomly assigned to take a statin or a placebo daily. Altogether about 40,000 healthy but high-risk people, aged 55 to 82 years, participated in these clinical trials, with the statin doses ranging from 10 mg to 40 mg a day. Participants were primarily males with high cholesterol and other risk factors, such as smoking and angina (chest pain caused by constrictions in the coronary arteries). In one trial, the men and women had either normal or borderline levels of cholesterol. Several reviews of the five clinical trials came to the conclusion that statins can reduce the rate of non-fatal heart attacks and strokes. The drugs also reduce cardiovascular mortality, but they did not reduce all-overall mortality.

Conveying the Benefit to the Public:
Interestingly, the Newsweek article devoted only one sentence to the critical question of what has been proven regarding statins. Without further explanation, the article says a large study “showed that cholesterol-lowering drugs reduced the risk of heart attack and stroke by at least one quarter for those at highest risk.” While this is roughly accurate, it appears more impressive than the reality. The one-quarter reduction refers to the difference in the rate of heart attack between the study participants taking statins and those on the placebo.

What makes the statistic misleading is the fact that healthy people–even those with high cholesterol–have a low risk of having a heart attack to begin with. And reducing their odds of having a heart attack by one-fourth simply means that 3% of the statin-treated study participants had a heart attack or stroke, as compared to 4% of the untreated participants (the placebo group). Or put another way: There were 1% fewer statin-treated people had heart attacks. The studies lasted only about five years so these statistics apply to taking the drug only for that length of time. (See Web sites listed at the end of this article for help in understanding risk assessment.)

It is not unusual for reviewers to look at the same trials and come to different conclusions about what has been proven. This is what happened when a Canadian team of researchers conducted its own review of the five statin trials. This new analysis took issue with the generally agreed upon conclusion that these five trials proved that the benefit of statins far outweigh the risks.

The New Analysis:
The analysis of the five trials was conducted by a team of researchers at the University of British Columbia led by James M. Wright, PhD, who came to the alarming conclusion that statins harm as many people as they help. True, the combined results of the five trials did, in fact, show a lower rate of non-fatal heart attack and stroke. However, once serious adverse events* were taken into account, the results were not so positive. The statin users did have 1.4% lower rate of heart attack within the next five years, compared with untreated people, but that small benefit was offset by a 1.8% rate of serious adverse events associated with the drug.

Dr. Wright and colleagues might be the first reviewers to step back and look at the big picture–assessing the serious risks as well as the benefits of statins. Only two of the five trials reported serious adverse events. “Based on the two trials, we are suspicious that some serious adverse events are being increased by statins and that this appears to be canceling the benefit of the reduction in heart attacks and strokes,” Dr. Wright wrote in an e-mail interview. The new analysis was published in the April-June 2003 issue of Therapeutics Initiative, an evidence-based drug therapy newsletter (“Do Statins Have a Role in Primary Prevention?” Available free at www.ti.ubc.ca).

Dr. Wright is associated with the Cochrane Collaboration, an international network of experts who conduct systematic reviews of the supporting evidence for drugs and other medical, surgical or behavioral interventions. In a move that distinguishes many Cochrane reviewers, Dr. Wright and his colleagues at the University of British Columbia contacted the authors of the three trials that did not publish the number of serious adverse events suffered by their study participants. The reviewers have yet to receive the requested data.

Yet to be Proved for Women:
In the e-mail interview, Dr. Wright was asked about statins’ proven benefit specifically to women–something omitted from the analysis as it appeared in Therapeutics Initiative. To answer this question, Dr. Wright did a separate analysis of women who participated in four of the five primary prevention trials, emphasizing that they made up only 28% of all the study participants. “Combined results of all trials do not support the use of statins by women without heart disease,” concluded Dr. Wright. This is explained by the fact that women were not only underrepresented in the trials, but also, as a group, have a very low risk of having a heart attack in a five-year period.

The University of British Columbia researchers are not the first to notice that the benefit of statin therapy to women remains an open question. High cholesterol has never been proven to be an important risk factor for women. At every stage of life, women tend to have higher blood levels of cholesterol than men of the same age; yet they are about 15 years older then men at the age of a first heart attack.

Statins have begun to replace postmenopausal hormones as the all-purpose drug to prescribe to healthy older women whose only risk factor is high cholesterol. It is noteworthy that many of the additional benefits claimed for statins–beyond cholesterol reduction–are similar to those made prematurely for estrogen. For example, some women are told that statins will also reduce their risk of Alzheimer’s disease and osteoporosis. The latter has been disproved, and the former comes only from preliminary studies.

More cases of breast cancer have shown up among statin users in three trials. In all three, the finding was described as “not statistically significant.” One trial involving people with heart disease who either took a placebo or 40 mg of Pravachol daily found that breast cancer developed in 12 out of 286 women taking the drug, compared to one out of 290 on the placebo.

People over 70
Whether high cholesterol is a problem for elderly people has been the subject of a long-running controversy. So has the question of whether cholesterol-lowering drugs can provide any benefit to this age group. The controversy was theoretically settled by a large multi-center European trial published in 2002 when The Lancet published a major trial, known by the acronym PROSPER. It showed that statins lowered the incidence of coronary events but had no effect on longevity. The PROSPER trial, however, lasted only three years.

The participants, aged 70-82 years either had heart disease (44%) or had risk factors for heart disease (56%). The PROSPER results showed an ominous increase in the frequency of new cancer diagnoses in the people taking Pravachol, which was dismissed as a “chance finding” by the authors. In response to the PROSPER trial three of five letters to the editor of The Lancet took issue with the description of “chance finding.” One letter noted that the cancer incidence over three years was 6.8% in the placebo group and 8.5% in the people taking Pravachol.

Another letter to the editor expressed concern that the PROSPER will encourage the use of statins in elderly people: “Surely one relevant statistic is that by treating 5,804 high-risk patients with pravastatin [Pravachol] or a placebo, the overall death rate [sic] was reduced from 306 to 298 over three years. This was achieved at what cost to the perception of good health, comfort, or anxiety among the participants?” wrote Peter J. Little of New Zealand (Lancet, 2/1/03). Such critics recently gained support from the new analysis by the University of British Columbia researchers who concluded that the cardiovascular benefit shown in the PROSPER trial was offset by serious risks.

Reaction to the New Analysis
The new analysis met with criticism from cardiologists in Canada, but it has been largely ignored in the U.S. The criticism centers on the fact that the University of British Columbia research team came to entirely different conclusions about statins than virtually all other medical organizations that have reviewed the same studies. In a recent article for the Toronto Globe & Mail, Dr. Ruth McPherson dismissed the research team because it did not include specialists in cholesterol metabolism and treatment. Furthermore, the findings were published in Therapeutics Initiative (TI) which “does not have the status of a peer-reviewed journal.”

TI, which is based at the University of British Columbia, is a newsletter that is peer-reviewed, according to its Web site, by family physicians, specialists, academic researchers, pharmacologists, pharmacists and epidemiologists. TI is funded by the Canadian Government to help doctors make evidence-based treatment choices. The average practicing physician does not have the time to pick through each statin trial to determine, say, whether women are represented in large enough numbers, or whether the odds of being harmed by a drug are equal to its odds of a benefit.

People with Heart Disease or Diabetes
Statins clearly benefit diabetics and people with heart disease who want to avoid a heart attack or stroke, as well as those who have already suffered one and want to prevent another. Such people are more likely to benefit from statin therapy because their odds of having a heart attack or stroke are so high. Pravachol and Zocor are the best assessed statins for people who have diabetes and/or heart disease. Altogether more than 35,000 people who fit this profile took part in trials that compared a statin with a placebo.

The most recently published large trial was conducted in the United Kingdom; 25% of the participants were women and 46% were over age 65 years. All had been randomly assigned to take Zocor or a placebo for five years. Results showed that the participants who took Zocor decreased their odds of overall mortality by 1.8% in the next five years, compared to those who were untreated (placebo group). Coronary deaths were reduced by 1.2% among statin users within five years. The reductions were higher for people who have already had a heart attack or angina and for diabetics. Contrary to expectations, Zocor showed no beneficial effect on fractures or dementia. As for the cancer-related concerns, Zocor did not alter the overall incidence of cancer ( Prescrire International, 8/03). No separate analysis has been done for women.

As for the importance of reducing fat intake, this particular lifestyle change has more relevance to people who have heart disease than it does to healthy people. Combined results of seven clinical trials involving participants with heart disease showed that dietary changes provided a 6.6% lower incidence of heart attacks and/or cardiovascular deaths than those who did not reduce fat intake.

Read these 2010 articles entitled, “Statins don’t work for people without heart disease” click here and “Statins to prevent stroke and heart attack” click here

Maryann Napoli, Center for Medical Consumers(C)
*Serious adverse events includes “any medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, or results in persistent or significant liability.”

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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: “Statins don’t work for people without heart disease”, “Drugs to prevent stroke and heart attack,” “(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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