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Cholesterol drugs
What you don’t know can hurt you


DRUG BUST by Alan Cassels
The people's briefing note on prescription drugs


I’ve been following the cholesterol saga – both the marketing and the science of the dreaded “high cholesterol” – for more than 15 years and I have come to a single conclusion: people, and I mean all of us, including specialists, researchers, physicians, nurses, pharmacists and patients, have no idea of the range of possible harms associated with taking a cholesterol-lowering drug.

Why do we have no idea?

My answer is the substance of this month’s column, which was born from my suddenly realizing the depth of our collective ignorance about the dangers of this drug class. To paraphrase Donald Rumsfeld who spoke of “unknown unknowns,” in the statin world, there are those things we do not know, we don’t know. With this incredibly popular drug class, there are forces conspiring to keep us flailing in ignorance in the dark.

Let me give it to you up front: Regardless of your age, if you are otherwise healthy with no history of heart disease, please avoid having your cholesterol tested. Don’t. Ever. Do. It. There. That’s my public health message for this month.

But you may ask, “If it’s not worth doing, why do all the experts, as well as my doctor, keep saying that watching our cholesterol is worthwhile? Why do so many organizations promote the testing and treatment of high cholesterol, including the American Heart Association, the American Academy of Family Physicians, the Canadian Cardiovascular Society and any group that has an interest in cardiovascular disease?”

Even the independent bodies we trust, such as the United States Preventive Services Task Force (USPSTF), which delivers some of the best evidence-based recommendations on screening, says, “The benefits of screening for and treating lipid disorders in all men aged 35 and older and women aged 45 and older at increased risk for coronary heart disease substantially outweigh the potential harms.”

Now this advice would be perfectly acceptable if we had a full account of the “potential harms” of statins – by this, I mean the bad things that can come with drugs such as Lipitor (atorvastatin), Crestor (rosuvastatin), Pravachol (pravastatin) and Zocor (simvastatin), among others.

On the ‘benefit’ side, most of us need a good slap to the side of the head to remind us that being labelled as having ‘high’ cholesterol is not the same as having a disease. It is a “risk factor” for a disease such as a future heart attack or stroke. But it’s a tiny risk factor. Miniscule. Most of us may want to reduce our risk of cardiovascular disease, but most of us aren’t told that tinkering with our cholesterol levels, through drugs or diet, does very little to reduce our overall risk.

Even in a “best case “ scenario, one in 20 very high-risk men would see a benefit of only five percent. Most people would never even get close to that level of benefit; most of us would get no benefit while still having to contend with considerable harm.

But back to the dangers of statins – drugs like Lipitor, Crestor or Zocor. What are the most common negative effects of these drugs?

For clarity, I talked to Dr. Beatrice Golomb, a professor in medicine at the University of California in San Diego and likely one of the world’s experts on the dangers of statin drugs. In 2008, she published an extensive literature review of the adverse effects of statins and to say it’s exhaustive is a gross understatement; this paper has 900 references!

And what effects did she find? The range of adverse effects associated with statins is incredibly broad, but the key adverse effects could be summed up easily in a quick soundbite: muscles, memory and mood.

The adverse effects happen more frequently in people taking higher doses of statins, but muscle pain and weakness, trouble remembering things and feeling generally irritable are the most common troublesome effects of statins. Statin users might also experience violent nightmares, liver and stomach problems, trouble with breathing, sexual difficulties and a range of other problems.

I called Dr. Golomb at her office in San Diego the same week her new study was published in the Archives of Internal Medicine. The study found that statins cause people to feel tired and have less energy. This study, while small, was a randomized trial and probably the first of its kind to provide solid evidence on something patients have known about and which the drug industry has been able to hide for years: Statins cause fatigue and adversely affect a person’s energy levels. Her study found that about four in 10 women taking a moderate dose of a drug like pravastatin or simvastatin had less energy and were more fatigued when they exercised.

When I talked to her, I realized pretty quickly that she and I have something in common: We had both spent part of our professional lives listening to people complain about the side effects they’d experienced while on statins. Both of us have heard many stories of physicians refusing to believe that these common side effects were real.

About 10 years ago, Dr. Golomb set up a study to collect reports of people who were taking statins. It was called the UCSD Statin Effects Study (www.statineffects.com). Unlike most research on statins, Dr. Golomb’s data were refreshingly innovative, consisting of real stories of real experiences of real patients who had taken statins and had problems. These data are a huge contrast to much of the published literature on the effects of statins because most of what you find in the medical journals is research that is a) funded by the pharmaceutical industry, b) biased, often not reporting full adverse events data and c) generally biased towards only the positive effects of statins.

No wonder our doctors have been kept in the dark.

In 2007, she published a study in the medical journal Drug Safety that analyzed the reports of over 650 patients. The key thing she found was what I would call “doctor denial.” This is the “I’ve never heard of that before” reaction that statin patients often get from doctors when complaining of sore and weak muscles, memory loss or any of the scores of nasty effects linked to statins.

When a doctor fails to recognize that a patient’s symptoms could be the side effects of a drug, a vicious cycle can ensue, with more drugs – perhaps anti-inflammatory drugs – being prescribed to treat the side effects. Statins can cause a long cascade due to its side effects, including drugs for anxiety or impotence. There are even reports of patients who experience adverse effects that look like Parkinson’s disease, leading, of course, to drugs for Parkinson’s disease.

Dr. Golomb has learned a lot about statins from what people have reported to her. Over the last six years or so, she has been publishing her survey results in medical journals and presenting them to doctors.

A 2010 study found that muscle-related problems were a very common complaint of statin users, maybe as many as 20 percent of people who take the drugs. And if the drugs prevent people from exercising, they are actually doing the opposite of what they should be doing to keep you healthy.

Many people can eliminate the adverse effects by taking a lower dose or stopping the statin altogether, but some are not so lucky; some statin users have adverse effects that are irreversible.

At the end of the day, most of what we know about the safety of statins is biased. The statin world has very few researchers like Beatrice Golomb and that’s a shame. The medical world’s efforts to screen and pharmacologically treat something as simple as your cholesterol levels is a phenomenon that I believe is largely rooted in ignorance. Some day, I suspect we will regard statins as an unmitigated scandal in medicine, the same way we now think of bloodletting, thalidomide or Vioxx.

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Alan Cassels is a pharmaceutical policy researcher at the University of Victoria and the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease (Greystone, 2012), in which he discusses, among other things, screening for high cholesterol. Read more of what he’s writing about at www.alancassels.com

 

 
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