It has become the received wisdom that cholesterol must be reduced to prevent heart attacks and that drugs known as statins are the best way do this.
There is some crazy logic and bad science behind this. UK government heart advisor Professor Roger Boyle suggested every man over 50 and every woman over 60 should take a daily statin. This approach has been taken to ridiculous extremes with some “experts” recommending that statins be put in the water supply or be handed out with the ketchup at burger bars.[i] The American Journal of Cardiology recently published an article suggesting that statins should be offered in complimentary packets with burgers. One of the authors, Dr. Darrell Francis, stated: “It’s ironic that people are free to take as many unhealthy condiments in fast food outlets as they like, but statins, which are beneficial to heart health, have to be prescribed.” Dr Francis is supported by a grant from the British Heart Foundation.
Many doctors in the UK are insisting that statins be taken as a preventive measure even by people, including children, with low cholesterol. When I lived in London, before the financial crash, dinner party conversation invariably revolved around house prices as ageing baby boomers plotted “Ski-ing” – “Spending the Kids’ Inheritance”.
I was surprised in Sri Lanka to hear a dinner-party guest, who clearly thought herself sophisticated, unashamedly discussing her bowel movements and haemorrhoid surgery. I soon learnt that Sri Lankans of all classes were somewhere on a spectrum between health-conscious to hypochondriac. Everyone “knows their numbers” as they say in the States. A conversational gambit might be, “I have cholesterol. How high is yours?”
There was a time when I had never heard of cholesterol and my ignorance did me no harm.
Many years ago I became a small cog in the prestigious machine that is the Study of Health and Stress carried out by Professor Sir Michael Marmot at London University.[ii] I discovered that my cholesterol levels were “at the high end of the normal range”. I was given a leaflet telling me what foods I should avoid in order to reduce my cholesterol. As I was practically a vegan at that time I did not see that there was much scope to make my diet more Spartan. No-one suggested I should take any medication.
In London I was told by my doctor to avoid cashew nuts, avocadoes and prawns. In Sri Lanka I was told to eat as much of them as I could.
What is cholesterol?
Why has cholesterol become a villain? What is it anyway? As Jenifer Anniston used to say: “Here comes the science.
Everybody “has cholesterol” – without it we would die. Cholesterol is a steroidal alcohol that helps provide structure to the membranes of all animal cells, an indissoluble molecule, a natural substance produced by the liver. Living creatures incorporate cholesterol into their cell walls to make them waterproof and to protect them against injury by oxygen. This is particularly important for the normal functioning of nerves.
Cholesterol is not something we want to clear our bodies of because 70% of our brain is made of fats and cholesterol. Cholesterol circulates in the blood stream in water soluble particles called lipoproteins.
Good and Bad
Those dinner party scientists will nod sagely and tell you that there is “Good” (HDL) and “Bad” (LDL) cholesterol. High density lipoprotein (HDL) carries cholesterol from peripheral tissues in the arterial walls to the liver. From the liver it is excreted with bile. Cholesterol is transported from the liver to peripheral tissues including those in blood vessels. When cells need extra cholesterol they call for the low density lipoprotein (LDL) to deliver the cholesterol into the cell’s interior. Between 60% and 80% of cholesterol in the blood is transported by LDL.
Why then does the common wisdom condemn LDL as “bad” and deem HDL “good”?
Risk factors and cause and effect.
People who suffer from heart disease may display a number of characteristics. Among these may be a high level of LDL. It does not necessarily follow that high LDL causes heart disease. Perhaps some mental confusion has arisen because of a misunderstanding of the term “risk factor”.
Gary Younge wrote in the Guardian in another context: “Because two things are co-related it does not mean that one causes the other. Shark attacks and ice cream sales both rise in the summer. That does not mean that ice cream attracts sharks or people react to fear of sharks by eating more ice cream”.
Being overweight is a risk factor in heart disease. Losing weight lowers LDL. A sedentary life style predisposes a person to heart disease. Exercise lowers LDL. Smoking is bad for the heart. Smoking increases LDL. Stress is bad for the heart and increases LDL. If heart attacks happen more often to people who smoke, who are overweight and suffer from stress it would be wise to give up smoking, lose weight and relax.
A US study was reported in the journal Chemistry and Industry. The study found that statins given to control cholesterol could increase the numbers of people with Parkinson’s disease. People with low levels of “bad” LDL were in excess of three times more likely to have Parkinson’s than people with high cholesterol. Now, one should not conclude from this that we need to take medication to increase our LDL because that will prevent us from suffering from Parkinson’s. The fact that people who have Parkinson’s tend to have low LDL indicates that low LDL is one of the risk factors predisposing people to Parkinson’s. It does not mean that low LDL is a cause of Parkinson’s.
It would not be wise to blame LDL for heart problems and to take drugs as quick fix to attack it while carrying on with an unhealthy life style.
Good diets and bad diets
It has become received wisdom that that animal fat is bad for the heart using the analogy of clogged-up drains.The road to hell is paved with false analogies.
Is “common sense” supported by the evidence? In Kenya the Masai believe that vegetables are suitable food only for cows. They do not consume much else but meat, milk and blood. They do not have heart attacks and their cholesterol level is 50% below that of most Americans.
In 1953, Ancel Keys published a paper in which he argued that there was an upward trend in the number of deaths in the US from heart disease. He stated that five times as many Americans as Italians died from heart attacks. Using data from six countries he claimed to demonstrate a close correlation between deaths from heart attacks and total intake of animal fat. The villainous ingredient in animal fat is cholesterol.
Keys made much of the beneficial effects of a Mediterranean diet. However tasty the food might be, Keys created a myth here. In Italy, the incidence of heart attacks is 2.5 times greater in Crevalcore than in Montogiorge, even though the average cholesterol was the same. Throughout Greece the diet is similar but people who live in Corfu are 16 times more at risk of a heart attack than people in Crete.
A WHO study shows low mortality and high mean cholesterol levels in all locations in France. Dr Bernard Forette and a team of French researchers found that the death rate for old women with very low cholesterol was five times as high as that for old women with very high cholesterol. These studies do not show that high cholesterol means early death or that low cholesterol ensures longevity.
Professor Marmot did a study of Japanese immigrants in the USA. Those who became used to the American way of life but preferred Japanese food, had heart disease twice as often as those who ate high fat American food but maintained Japanese traditions. This suggests that heart disease was not caused by cholesterol but had something to do with more general aspects of lifestyle.
There is a strange tendency for studies to be distorted to support the case for lowering cholesterol when the raw data might indicate the reverse. The most blatant example of this is the study undertaken in Framingham, Massachusetts. Many of the townspeople had their cholesterol levels tested over many years. The coronary vessels of those who died were tested. The conclusion of the researchers was that cholesterol levels predicted the degree of atherosclerosis. However, only 14% of all those who died were examined. The correlation was only a weak 0.36. Almost half of those who had a heart attack in Framingham had low cholesterol. Women with low cholesterol were as likely to die as those with high levels.
The Multiple Risk Factor Intervention Trial measured the cholesterol of 300,000 middle aged American men. The researchers concluded that the risk of a heart attack for someone with a cholesterol level above 265 was 413% higher than the risk for someone with cholesterol below 170. This shocking conclusion is undermined by the brute fact that 99.4% of the 300,000 did not die of a heart attack. 98.7% of those with the highest cholesterol levels were still alive after six years. The difference in the number of deaths between those with the highest and the lowest cholesterol levels was 1%.
In the huge INTERHEART study on 30,000 subjects in 52 countries, the effect of many modifiable risk factors on heart attacks was studied. Smoking led the list, but total cholesterol and LDL were not even listed, perhaps because the outcomes were not the ones desired by some of the sponsors of the study, which included AstraZeneca, Novartis, Aventis, Abbott Labs, Bristol-Myers Squibb, King Pharma and Sanofi-Synthelabo.6
Dr Kroop, in the Netherlands, studied men who had extensive atherosclerosis and cholesterol of at least 312. All were treated with simvastatin. Half were treated with a drug that chemically removed most LDL. The researchers were confident that they could retard or reverse atherosclerosis. There was no correlation between cholesterol lowering and angiograph changes.
The most helpful book for the layperson on the history and science of all this is written by a layman, Anthony Colpo, who provides an impressively compendious synthesis of a mountain of research and provides copious notes and references so that one can check his sources.[iii]
There is much anecdotal evidence of side effects from statins. For example, statins have been associated with pancreatitis, tendon problems, depression, sleep disturbances, memory loss, sexual dysfunction, cataracts, osteoporosis, peripheral neuropathy, hemorrhagic stroke and rare cases of interstitial lung disease.
Dr. Beatrice A. Golomb has carved out a niche investigating side effects of statins, particularly in women, urges caution. She claims that studies so far have not demonstrated a survival benefit for women, lower-risk men and men and women older than 70.
Impaired memory and thought are more likely to have a profound effect on seniors’ independence, while muscle weakness from the medications could make them more vulnerable to the perils of falling.
I myself felt very low and disorientated when I was taking statins five years ago. I felt better when I stopped and my cholesterol reduced dramatically.
“There’s a huge literature of not-very-good studies” that link statins to a variety of problems”, said Dr. Richard H. Karas, director of preventive cardiology at the Tufts Medical Center in Boston.
You can pretty much find any disease, given the millions of people taking statins,” said Dr. Gregg C. Fonarow, a professor of cardiovascular medicine at UCLA.. But when the results of randomized trials are pooled, “you don’t [usually] find statistically significant differences between the statin and the placebo.”
I threw this question open to debate on my blog at Open Salon, to which a large number of practising MDs contributed. One of my Open Salon doctors was dismissive about my citing rhabdomyolysis as a possible side effect of statins. “If you have a 50% chance of having a deadly stroke in the next year are you ‘healthy’? What if you have a 20% chance? What if you have a 10% chance? What is ‘healthy’ anyway? A better question is: ‘At what point are you willing to run the 1:10K chance of rhabdo (reversible with cessation of the drug btw) in order to reduce your chance of a debilitating stroke?… Hey, your choice. For me, between a stroke resulting in death or permanent debilitating weakness, vs a laboratory abnormality that will go away when I stop taking the drug, I know which one I’d pick. Never mind that way more people get strokes than get rhabdo from statins. I’ve seen exactly one case of statin-induced rhabdo and I-don’t-know-how-many awful strokes.” Rhabdo is a very serious condition. It occurs through trauma from natural disasters such as the Blitz and earthquakes. It also occurs in people who abuse recreational drugs. Rhabdo has recently afflicted Redskins’ defensive tackle Albert Haynesworth. Rhabdomyolysis is a significant cause of acute renal failure, and may account for as much as a quarter of the cases of this condition. Rhabdomyolysis patients who experience acute renal failure may have a mortality rate as high as 20%. The condition also causes vomiting, confusion, coma and abnormal heart rate and rhythm. Furthermore, damage to the kidneys may lead to a marked decrease or absence of urine production, usually about 12–24 hours after the initial muscle damage. It is not a straight choice between having a stroke and having rhabdomyolysis.
In the August 21 2003 issue of the American Journal of Cardiology, [iv]Dr H Brian Brewer Jr, a senior scientist at the NIH (National Institute of Health), wrote: “No cases of rhabdomyolysis occurred in patients receiving [Crestor] up to 40 milligrams”. This evades the fact that eight cases of rhabdomyolysis were reported during clinical trials of Crestor. The LA Times obtained FDA records under the Freedom of information Act. These records show that one patient got rhabdomyolysis while taking only ten milligrams. FDA records show that 78 patients got rhabdomyolysis taking Crestor during its first year on the market and two died. Baycol was withdrawn from the market after at least 31 reports of fatal rhabdomyolysis, an adverse reaction involving the destruction of muscle tissue that can lead to kidney failure. A new study by researchers from the Tufts University School of Medicine in Boston, judged Crestor to be the most dangerous of the popular cholesterol-lowering statin drugs, because of its effects on muscles and kidneys.
Whores for Big Pharma
Dr Brewer dismissed fears of side-effects. While making recommendations on behalf of the NIH Brewer was being paid by the companies that sell the drugs.
These doctors who are blasé about the effects of statins are avoiding a core ethical issue. We might accept the side effects of a drug if they are less serious than an illness that is being cured. We might accept iatrogenesis if the benefits outweigh the costs and we were really ill to start with.
All drugs act upon the liver and kidneys while passing through the body doing good work. It is a rather different matter to take iatrogenic risks with healthy people including children.
Why is low good?
Lowering cholesterol in itself might have harmful effects. Dr Joseph Mercola, writes in Huffington Post: “What if your cholesterol level is too low? Brace yourself. Probably any level much under 150 — an optimum would be more like 200. Now I know what you are thinking: “But my doctor tells me my cholesterol needs to be under 200 to be healthy.” Well let me enlighten you about how these cholesterol recommendations came to be. And I warn you, it is not a pretty story. This is a significant issue. I have seen large numbers of people who have their cholesterol lowered below 150, and there is little question in my mind that it is causing far more harm than any benefit they are receiving by lowering their cholesterol this low.”
One large study conducted by Dutch researchers found that men with chronically low cholesterol levels showed a consistently higher risk of having depressive symptoms. This may be because cholesterol affects the metabolism of serotonin, a substance involved in the regulation of your mood.
On a similar note, Canadian researchers found that those in the lowest quarter of total cholesterol concentration had more than six times the risk of committing suicide as did those in the highest quarter.
Dozens of studies also support a connection between low or lowered cholesterol levels and violent behavior, through this same pathway: lowered cholesterol levels may lead to lowered brain serotonin activity, which may, in turn, lead to increased violence and aggression.
Dr. Ron Rosedale points out: “If excessive damage is occurring such that it is necessary to distribute extra cholesterol through the bloodstream, it would not seem very wise to merely lower the cholesterol and forget about why it is there in the first place. It would seem much smarter to reduce the extra need for the cholesterol — the excessive damage that is occurring, the reason for the chronic inflammation.”
Statins’ aim is not true
Statins work by blocking 3-hydroxy-3-methylglutaryl coenzyme A reductase, an enzyme in the liver. Unfortunately statins cannot be specifically targeted on that but as collateral damage also inhibit the synthesis of many important intermediate metabolites.
Statins have been shown to deplete the body of a coenzyme known as CoQ10, a powerful ant-oxidant which is a crucial component of mitochondria and is essential to producing almost all of a cell’s energy requirements. High levels of CoQ10 are found in healthy heart tissue. Statins, by reducing CoQ10 have been shown to be linked to an increase risk of congestive heart failure which is the fastest growing cardiovascular disorder in the USA.[v] The only cure is a heart transplant.
Creating illness for profit
Sally Fallon, the president of the Weston A. Price Foundation, and Mary Enig, PhD, an expert in lipid biochemistry, have gone so far as to call high cholesterol “an invented disease, a ‘problem’ that emerged when health professionals learned how to measure cholesterol levels in the bile.
Professor Donald Light, a professor of comparative health policy at the University of Medicine and Dentistry in New Jersey, US, in a paper presented to the 105th Annual Meeting of the American Sociological Association, claims that 85% of new drugs offer few if any new benefits — but they carry the risk of causing serious harm to users.
He said the pharmaceutical market was one in which the seller knows much more than the buyer about the product, and takes advantage of this fact. “Current incentives for research produce a few drugs that substantially improve patients’ chances of getting better or avoiding death but a large number of barely innovative drugs each year…are of little benefit and consume about four-fifths of all drug costs. The incentives and institutional practices around testing and regulatory review predictably result in approvals being based on trials so biased and poorly run that no one knows how much better or worse new drugs are.” [vi]
An estimated 85% of new drugs offer few if any new benefits while having the potential to cause serious harm due to toxicity or misuse. “Sometimes drug companies hide or downplay information about serious side-effects of new drugs and overstate the drugs’ benefits,” said Professor Light. One study of 111 final applications for approval found that 42% were missing data from adequately randomised trials, 40% were supported by flawed testing of dosages, 39% lacked evidence of clinical efficacy, and 49% raised concerns about serious adverse side-effects.
Physicians were “double agents” – promoters of the new drug, yet trusted stewards of patients’ health. When patients complain of adverse reactions, studies show that doctors are likely to discount or dismiss them, according to Prof Light.
Prof Light highlighted the marketing of statin cholesterol-lowering drugs as a good example of Pharma hype. Company-supported clinical researchers and medical writers created a global market by manipulating a complex set of relationships between heart disease and saturated fats and cholesterol had been converted into the simple message that “cholesterol kills”.
Yet two major trials of statins found little evidence that the drugs reduce the risk of heart attacks. In contrast, they showed an increased total risk of harm to health and death from the drugs despite the lowering of cholesterol levels.
One major meta-analysis, which pooled the findings of a number of studies, found that “statins were not associated with reduction in the risk of all-cause mortality”.
Another trial led by a statin manufacturer was stopped early so that adverse side-effects were not recorded. Since the first statin was launched in 1987, it has been a boon for Big Pharma. Pfizer’s Lipitor achieved sales of $10 billion a year, becoming the world’s best selling prescription drug.
This is an example of the marketing genius of the pharmaceutical industry. Why restrict your profits by selling medicine only to sick people? The market is unlimited if you target healthy people.
Cholesterol-lowering drugs now generate $25 billion a year for the drug companies. Sales have soared because of the huge increases in the number of people classified as having “high” cholesterol. In 1990, the official US guidelines for measuring high cholesterol meant that 13 million Americans “needed” statins. In 2001, the guidelines were re-written and the potential market was immediately increased to 36 million. Five of the fourteen authors of the new definition of what constituted high cholesterol had financial ties to the drug manufacturers.
In 2004, a further redefinition expanded the potential market to 40 million. Eight of the nine experts on that panel were taking money from the drug companies.[vii] Why stop there?
Why not ignore the cholesterol levels completely and give statins to everyone in the cause of prevention? The ambition of the drug companies is to market statins to everyone, even small children, whether they are at risk of heart disease or not, whether they will benefit from the drugs or not. A recommendation from an influential doctors group that some children as young as 8 be aggressively treated with cholesterol-lowering drugs has triggered debate because there are no long-term studies for children.[viii] Barbara Hutten and colleagues from the University of Amsterdam’s Academic Medical Centre randomly gave the statins or a placebo to 214 children, between eight and 18, with a genetic condition called familial hypercholesterolemia (FH), which causes very high levels of low density lipoprotein cholesterol, commonly called “bad” cholesterol, from birth onwards. Dr Hutten said: “Our data support early initiation of statin therapy in FH children, which might yield a larger benefit in the prevention of atherosclerosis later in life. In our opinion, physicians should consider statin treatment for all FH children who are eight or older.” Ultrasound scans were used to measure the wall thickness of the carotid artery in the neck – a recognised method of checking the narrowing of blood vessels. The findings, published in Circulation, the journal of the American Heart Association, showed that the earlier statin therapy was started the less the arteries thickened. The researchers say that the artery wall would grow 0.003 millimetres thicker for every year that the start of treatment was delayed.[ix] The children were treated for at least 2.1 years and the longest for up to 7.4 years. No serious side-effects were found but the trial was too small to be sure about the safety of the treatment and the researchers said further trials were necessary.
“There may be some pressure to start them on drugs to make these numbers better,” said Dr. Thomas B. Newman, an epidemiologist and paediatrician at UC San Francisco. He also worries that the acceptance of drug use would shift the focus of treatment away from diet and exercise.[x]
We have to be skeptical in our skepticism because there is also a thriving little industry of people making a living from attacking The “cholesterol myth” and pushing their own books and remedies. Witch , sorry which, doctors do we believe? I put this question on my blog at Open Salon, to which a large number of practising MDs contribute.
Many qualified doctors oppose the cholesterol conspiracy. Perhaps the pioneer was Uffe Ravnskov.[xi] The initial response to my queries was along the lines of: “Doctors have had extensive, intensive and expensive training. They also keep up with the latest research and developments. The layperson should do what the doctor says.” I asked specific questions: “Do you think that cholesterol is a serious health risk or do you agree with those other qualified medical practitioners who think that the danger from cholesterol is a myth? “Do you think that stains should be prescribed to people who have low cholesterol?”
When pressed with the argument that many well-qualified doctors seriously doubt that cholesterol is a problem at all and question the wisdom of promiscuously prescribing statins, one particular doctor, Amy Tuteur MD, abdicated from a position of lofty certainty and said it was unfair if we don’t recognise that doctors are fallible. “In other words, treatment recommendations are being issued in a state of imperfect knowledge. Therefore, they are constantly being revised. The same thing applies to statins. In order to know whether they work, who they work for, what the side effects are and what the long term consequences of statin use are, we need to have 50 years of data on millions of people. We don’t have that, and we won’t have it for decades. Only time will reveal the truth about statins, positive or negative. Until then, all of us have to muddle along with the limited (but growing) information that we have available.”
Another doctor tried to absolve doctors from any blame for the growing ineffectiveness, through over-prescribing, of anti-biotics. “We’re taught not to do that. But see how long you last when faced with a screaming parent making a scene in the ER because you won’t give her kid abx for a viral infection.”
Blame the patient
I sensed a disturbing theme emerging: blame the patient. Doctors are all-knowing and patients should do what they are told. If anything goes wrong it is the patient’s fault. However, the doctor gives in when the patient is demanding anti-biotics and that is why anti-biotics are becoming ineffective?
I consulted my friend Dr Barbara Schumm who has been practising medicine in the UK for many years. She told me: “In British medicine we have the notion of NNT which is ‘numbers needed to treat’ i.e. the number needed to take the medication to prevent one event. Usually that figure is in the hundreds. If this concept is used to explain risk, very many patients feel that they would prefer to take the chance rather than take medication every day of their lives with no clear gain. There is an element of ‘the Emperor’s Clothes’ in all of this and certainly all the vested interests in the drug industry are reluctant to be honest about their findings”.
According to the Hippocratic Oath, doctors should not perform unnecessary surgery or take unnecessary risks by prescribing treatment of dubious value and possible harm. Under the spurious banner of “prevention” possible harm is being done, anxiety is being created, resources are being misdirected and fortunes are being made. Is it ethical to spend billions on the possibility of slightly reducing heart disease in the affluent west when all over the world millions are dying from the diseases of poverty?
[i] American Journal of Cardiology, Volume 106, Issue 4 August 2010 http://www.ajconline.org/article/S0002-9149%2810%2900870-2/abstract
[iii] The Great Cholesterol Con, Anthony Colpo [iv] American Journal of Cardiology [v] Langsjoen, PH & AM, Biofactors, 2003
[vii] Selling Sickness. Moynihan, Ray and Cassels, Alan, Allen & Unwin, NSW 2005.
[xi] The Cholesterol Myths New Trends Publishing Washington DC 2000. Conspiracy theorists may raise an eyebrow at the fact that the cover of Dr Ravnskov’s book is designed by Sally Fallon and she contributes a flattering blurb