“The thalidomide disaster of the 1950's will pale by comparison to the dramatic rise and fall of the statin industry.” -- Stephanie Seneff, MIT Senior Research Scientist and author of How statins work explains why they really don’t work.

That’s an astonishing claim, but one that deserves to be taken seriously. Statin drugs are the most widely prescribed class of drug in the world, accounting for billions of dollars a year in sales. One statin, Lipitor, is now the world’s largest-selling branded pharmaceutical and in 2008 alone was worth 12.4 billion dollars in sales receipts to its maker, Pfizer. Millions of people take these drugs each day in order to lower their blood cholesterol levels. The question is, why?

That may sound like a frivolous question, but it’s not. As Stephanie Seneff explains, three features that distinguish animals from plants are sentience, mobility, and cholesterol – and cholesterol is what enables the other two. Cholesterol helps to regulate the passage of substances across the cell membrane, which enables the buildup of an electrical potential across the membrane, which in turn enables nervous transmission and muscle contraction. Without cholesterol, we would not be here discussing these matters.

Cholesterol also serves as the substrate for the synthesis of vitamin D₃, the sex hormones estrogen, progesterone, and testosterone, the glucocorticoid hormones such as cortisol, and the mineralocorticoid hormones such as aldosterone – vital substances all.

Statin drugs work by blocking the action of the enzyme HMG Coenzyme A Reductase, which catalyzes an early step in the 25-step pathway by which cholesterol is synthesized. Blocking this step also blocks the synthesis of Coenzyme Q₁₀, an essential component of the electron transport chain by which your cells oxidize organic compounds in order to extract energy from them.

Statin drugs also block the synthesis of dolichols, which function in the posttranslational modification of proteins in the endoplasmic reticulum. Reduced levels of dolichols are characteristic of the brains of patients suffering from Alzheimer’s disease.

Are you still sure monkeying with your cholesterol levels by taking statin drugs is such a good idea?

How do the biochemical effects of statins play out on an organismal level? Muscle pain and weakness have long been acknowledged as side effects of statin therapy. Seneff and her colleagues wanted to find out just how common statin-associated muscle and nerve damage was. They collected 8400 online reviews of statin drugs and compared them to 8400 reviews of other drugs. The comparison group was selected so that the age distribution of the reviewers was comparable to that for the reviewers of statins. Compared to non-statin drug reviews, statin drug reviews indicated a significantly higher rates of muscle cramps, general weakness, muscle weakness, loss of muscle mass, numbness, and muscle spasms.  

Over time, muscle damage can lead to rhabdomyolysis, a condition in which the muscle cells melt down into a horrible toxic sludge, which in turn can lead to kidney failure. Statin drug reviews indicated significantly higher rates of both rhabdomyolysis and kidney failure.

We have already noted that statins interfere with the synthesis of Coenzyme Q₁₀, an essential component of the electron transport chain. If this pathway is blocked, cells must switch to lactic acid synthesis to stay alive. Lactic acid toxicity may in turn set in motion a cascade of events leading to amyotrophic lateral sclerosis, or Lou Gehrig’s Disease. Statin drug reviews indicated significantly higher rates of ALS.

The highest concentration of Coenzyme Q₁₀ is found in the heart. Statin drug reviews indicated significantly higher rates of heart failure.

Cholesterol plays an essential role in the uptake of glucose from the bloodstream into the cells. Statin drug reviews indicated significantly higher rates of diabetes.

25% of the cholesterol in your body is found in your brain. Statin drug reviews indicated significantly higher rates of memory problems, Parkinson’s disease, neuropathy, and dementia.

Are the conclusions of Seneff and her colleagues to be trusted? My guess is that, if anything, they underestimate the rate of statin-associated side effects. For one thing, the side effects of statins are easily confused with the normal effects of aging. For another, a recurring theme on internet message boards is that of doctors telling patients their symptoms couldn’t possibly due to statins:

“Incredible depression almost immediately after I started taking [Lipitor]. Crying all the time, not sleeping, re-living of past terrible events that had occurred in my life, like someone pushing a doorbell and holding it to keep ringing and re-living all the terrible negative things in my life over and over again. I kept asking my doctor if there were any side effects like mine and he said no."

“Muscle aches as well as tingling in arm and hand, sore shoulder, fatigue, poor sleep although it did lower my cholesterol, I was not warned of the symptoms. Surprisingly when I told my doctor I was having these problems he did not suggest stopping the Lipitor nor did any of the other specialists I went to see for these symptoms… I have since changed doctors because my doctor told me he did not believe it was the Lipitor since it should have affected me on both arms and hands, but as soon as I stopped the Lipitor I started to feel better."

“Insomnia, loss of dreaming, inability to visualize; muscle pain, weakness, atrophy; tendonitis, tendinopathy, tendon contracture; meniscus damage; working memory and short-term memory loss, language and learning ability loss including spoken and written aphasia and inability to read; gall bladder disease, pancreatitis, acid reflux; inability to walk... I kept taking myself off this drug, was told it COULD NOT BE THE DRUG, urged to go back on, recovering somewhat each time, but finally the damage was not reversible."

Why do people take this stuff, again? To lower cholesterol, of course. And why would you want to do that? A meta-analysis published in Archives of Internal Medicine found that for every 100 patients treated with statins for five years, there would be two fewer non-fatal heart attacks but no difference in either coronary heart disease mortality or overall mortality. In other words, for every 100 patients who took these drugs for five years, 98 of them received no benefits whatsoever. Contrary to what you may have been led to believe, lowering cholesterol is not, in and of itself, a benefit. It is a benefit only if it help you to avoid a heart attack or premature death or some other untoward outcome. And most of the time, it doesn’t.

The words “science” and “medicine” carry with them an authority which is not always earned. If you have 50 children diagnosed with Type I Diabetes, and you give them the correct dose of insulin, you might reasonably expect all 50 of them to reach adulthood. If you have 50 people with serious infections, and you give all 50 of them the correct antibiotic, you might expect all 50 of them to recover. If you have 50 sedentary middle-aged people and you give them statins for five years, you might expect them to have one fewer heart attack, but you don’t really know that. You just have to take that on faith. You certainly can’t identify the one patient out of 50 who was spared.

We can’t assume that even the meager benefits demonstrated in clinical trials are forthcoming in the real world. The average senior citizen takes five prescription drugs or supplements a day. How are all these different drugs interacting? Are they lengthening the patients’ lives, shortening them, or having no effect? I don’t know. You don’t know. The docs prescribing these drugs don’t know. This is a gigantic uncontrolled experiment.

We do know that between 1980 and 2003, per capita spending on drugs, adjusted for inflation, rose by seventeen times. Not seventeen percent more – SEVENTEEN TIMES as much. And during that time, life expectancy at 80 barely budged, and I’d wager most of that increase – maybe all of it – is because fewer people are smoking.

In his book, Overdiagnosed: Making People Sick in the Pursuit of Health, Dr. H. Gilbert Welch points several problems that arise whenever you have “diseases” like high cholesterol which produce no symptoms and which are defined solely on the basis of arbitrary numerical values. Because of the properties of the normal distribution, every time you lower the cutoff point between normal and abnormal, the number of people defined as “abnormal” goes up exponentially. Because they are less “abnormal” to begin with, the potential to help them goes down, while the potential to harm them probably goes up (common sense would seem to indicate it’s easier to reduce cholesterol to dangerously low levels if your cholesterol isn’t so high to begin with). What does all this portend for the recent proposal to make Lipitor available to people over the counter – without even having to get their cholesterol checked first?

And remember there is not a shred of data that show that statins produce measurable benefits for people who exercise, eat sensibly, maintain a healthy body weight, and refrain from smoking and excess drinking. No one has ever done a study like that, and no one ever will.

People won’t do these things, you say? Well, yeah, it’s true that people have this annoying tendency to do what they want to do, instead of doing what their self-appointed betters want them to do. But the older I get, the more I come to see that the solution to a lot of our problems is not to consider them problems.

I believe in living and letting live. If your idea of a good time is sitting on a barstool, smoking and drinking and stuffing your face with nachos, then I say, Go for it. Eat, drink, and be merry. But then why interrupt the merrymaking with this fussy, fearful, hypochondriacal preoccupation with cholesterol which is unlikely to do you any good, and highly likely to produce noxious and/or debilitating side effects? I happen to think people ought to live their lives with a Hell of a lot more verve.

Pfizer’s ads say, “If you think your high cholesterol isn’t a problem, stop kidding yourself. When healthy diet and exercise are not enough, adding LIPITOR may help.” Do you really think Pfizer gives a crap if you exercise and eat a healthy diet?

Stop kidding yourself.