The (Over)Use of Statin Drugs May be Preventive Medicine Gone Awry

America is waging its war against heart disease with stockpiles of statins.

More than one of every six adults—nearly 40 million people—now takes these cholesterol-lowering drugs. Millions more could be buying them soon, since the Food and Drug Administration took the unprecedented step last year of allowing one company to market its statin to prevent heart disease—rather than to control only existing heart problems.

But some health experts are now worrying that our infatuation with statins may be spiraling out of control. Not only do many doctors question whether statins should ever be used to prevent heart disease, but some are dubious that these medications have ever been the miracle drugs they are advertised to be.


This will be the first of a six-part series of original reporting from Rochelle Sharpe on various topics related to health, wellness, and prevention. A Pulitzer Prize-winning journalist, Sharpe has more than 25 years experience and has worked as a staff writer for The Wall Street Journal, Business Week and USA Today.


Clearly, statins have been lifesavers for millions who suffer with severe heart problems. They also have become a lifeline for the pharmaceutical industry, generating $35 billion in sales in 2009 alone. Lipitor is now the best-selling drug in the world.

Lost in the euphoria over these drugs’ obvious benefits are warnings about statins’ serious side effects as well as persistent questions over how well these drugs work for women and the elderly.

Statins may do a fabulous job of lowering cholesterol. But lowering cholesterol does not always translate into preventing heart attacks, let alone extending lives, experts say.

Just last month, scientists raised questions yet again about statins’ benefits in a leading journal of evidence-based medical research. Writing in the Cochrane Review, these experts concluded that using statins to prevent heart disease “is not supported by the existing evidence.”

The authors analyzed the 14 most pertinent studies on the topic, 13 of which were sponsored by the pharmaceutical industry. Many of these studies’ conclusions were misleading, they wrote, with more than half not mentioning any side effects and more than a third leaving out results from clinical trials.

“Drug companies are manipulating what we know,” says John Abramson, a Harvard medical school professor and long-time critic of the drug industry’s aggressive promotion of statins.  Abramson, the author of Overdosed America, contends that our medical knowledge is being “commercially distorted.”

The debate over statins underscores just how much influence the drug industry has over health care issues. Not only do pharmaceutical manufacturers sponsor or ghostwrite many academic studies on drugs—including statins, but the companies also finance the continuing education courses that doctors take to keep up-to-date on drug usage.

In addition, the industry has had a surprising influence over the clinical practice guidelines on cholesterol, issued by the National Institutes of Health. These guidelines, last updated in 2004, were written by a panel of nine experts, eight of whom had financial ties with statin manufacturers. Physicians rely on these guidelines in their practices and those who ignore them can pay a huge price—losing incentive pay, getting rated by insurance companies as providing lower quality care, or giving malpractice attorneys ammunition against them if they should make a medical mistake.

Of course, the drug industry does not taint everything it financially supports. But research has shown that clinical trials funded by the industry are significantly more positive than other studies. A study published in the Journal of the American Medical Association concluded this may be due to biased interpretation of trial results.

As for statin research, some academics have been astounded by the misinterpretation of studies.

“The guidelines for cholesterol reduction don’t reflect the studies at all,” says Beatrice Golomb, a medical professor who leads the Statin Effects Study at the University of California in San Diego. “This is very troubling to me.”

Instead of presenting a balanced approach to preventing heart disease, the guidelines focus on getting doctors to lower LDL cholesterol, Abramson says. That approach is driven by drug company goals, he says, pointing out that the pharmaceutical industry and doctors often are seeking answers to fundamentally different questions.

Doctors want to know how to best reduce their patients’ risk of dying from heart attacks, while pharmaceutical companies are more focused on what drugs they can sell to cut cholesterol and alleviate cardiovascular problems.

The answers to these questions are surprisingly different. Statins certainly lower cholesterol. But half of all people who get heart attacks have normal cholesterol. And low cholesterol does not appear to be the key to longevity for the elderly or for women.

The famous Framingham Heart Study, which began tracking the health of 5,000 residents of Framingham, Mass., in 1948, shows that high cholesterol is significantly related to higher risks of  heart disease deaths only through age 60.

“Lowering cholesterol with statins does not extend life in elderly persons, even those at high risk of heart disease,” Golomb concluded in an article in Drug Safety.

High cholesterol may actually protect the elderly from catastrophic illnesses, she contends. For those over 75, low cholesterol appears to be a risk factor for strokes and deadly heart arrhythmias, she says.

Cholesterol does not appear to affect women in the same way as men, Golomb says. This complex substance, which is vital to synthesizing several hormones, including sex hormones, does not appear to be as deadly to women as in men.

Women with high cholesterol may have more heart attacks than women with lower cholesterol, she says. But they do not have more heart attack deaths or higher overall death rates.

Clearly, statins can bring enormous benefits to middle-aged men with high risks of heart disease—the very people who have participated in most of the statin drug trials.

But the extraordinary benefits of these drugs on middle-aged men have overshadowed statin risks, which are not trivial. Just last year, a study appeared in the The Lancet, a British medical journal, linking statins to increased risks of diabetes. Meanwhile, the sole clinical trial that focused exclusively on people over 70 taking statins showed a statistically significant increase in cancer—a finding that remains highly controversial.

It is unclear how many people get side effects from these drugs, but most likely it’s only a small percentage—perhaps between one percent and five percent of statin users. Those who do experience side effects, though, often find them debilitating—and irreversible.

Muscle difficulties are the most common problem, Golomb says, with many people suffering from severe muscle breakdown and excruciating pain. “I am only 44 years old, but my physical activity is like an 80-year-old,” one woman told her. Another complained: “This cholesterol drug crap is worse on my health than cancer was. It’s been 14 months and I still have problems.”

Golomb says that statins may kill some muscle cells and could interfere with the muscles’ response to physical activity. In a study of 22 professional athletes taking statins, 16 discontinued the drug because of muscle problems.

Cognitive problems, such as memory loss, are the next most common side effect, Golomb says, with women and the elderly suffering the most. Some patients experienced amnesia, while others lost their ability to read or balance checkbooks. Some were diagnosed with dementia or Alzheimer’s disease, but they quickly recovered after discontinuing their drugs.

Many doctors are not aware of these drugs’ dangers.

When Golomb asked patients how their doctors reacted to their complaints, most said they dismissed the possibility that the drugs had caused problems. Although the side effects have been discussed extensively in medical journals, some doctors told patients that statins had no side effects. Others attributed the pains as just the normal aging process. One patient said her doctor dismissed her, saying “I just didn’t like taking pills.”

Doctors are supposed to report side effects to the Food and Drug Administration. Given these attitudes, it’s no wonder that the government has a hard time getting a handle on how drugs actually work in the general population.

Half of all dire side effects, which lead to drug withdrawals or black box warning labels, are not identified until seven to 25 years after a drug’s release, Golomb says.

So, how are consumers supposed to cut through all the drug industry-sponsored material to figure out the best way to improve cardiovascular health?

Dr. Abramson suggests they return to the Framingham Heart Study, which found two interventions that helped reduce mortality in all patients: exercise and a healthy diet.

Rather than spending so much time fixing illnesses with pills, he says, the nation needs to wrest control of the health care debate away from pharmaceutical companies and focus more on prevention.

“We’re going about solving the problem of making people healthy in the wrong way,” he says.


Contributing Writer Rochelle Sharpe is a Pulizter Prize-winning journalist with more than 25 years of health writing experience. Sharpe’s bi-monthly news feature for the Health Policy Forum focuses on issues related to health, wellness, and prevention. As a leading nonprofit health care research and consulting institute dedicated to improving human health, Altarum encourages open discussion and debate about the many challenges in health care today. All postings to the Health Policy Forum (whether from employees or those outside the Institute) represent the views of the individual authors and/or organizations and do not necessarily represent the position, interests, strategy, or opinions of Altarum Institute. Altarum is a nonprofit, nonpartisan organization. No posting should be considered an endorsement by Altarum of individual candidates, political parties, opinions, or policy positions.


I found your blog of great interest as I am one of the few who is still experiencing the side effects of statins. Following 2-3 months of statin therapy I developed a very severe case of polymyalgia rheumatica. Initially I was prescribed 20 mg BID of prednisone to control the pain. Now, over one year later, I am still on 15 mg of prednisone a day.
Naomie Anderson from the BCBS TEC stated in a talk last year that the cost of treating the side effects of statins is greater than the actual cost of the drugs. This seems hard to beleive but may be a quote you might want to seek out should you write a future article on statins.

Hi, I am stunned at your experience with statins and the Polymyalgia Rheumatica (PR). I took Lipitor for 3 years in the early 2000′s but stopped because I was so concerned with what I was reading about the side effects. I did not have any myself. In 2007 I developed PR out of the blue plus severe depression. I had never even heard of PR. I was put on 20mg Prednisone and the muscle and joint pain got better. I am still on 5mg pred every other day but can’t seem to get off it completely. Here is the interesting thing. My LDL has been very high since going off the Lipitor. A few months ago my MD finally talked me into going on Zocor. I have some muscle and joint pain anyway with the PR. I never knew there was a connection to the statins. I am going to talk to my MD right away about this and stop the statins before my PR gets even worse. I have to say that I couldn’t understand where that PR came from. I am glad I saw this blog!!!!!

Thank you for your excellent piece. At the age of 23 I found myself with a slightly elevated LDL. My PCP immediately prescribed an aggressive dose of Simvastatin to lower my cholesterol. He presented the drug as a miracle drug and told me that there was essentially no other way to lower my cholesterol enough to avoid a heart attack by age 30 without it. Within weeks I was experiencing unexplained muscle fatigue and pain and severe carpal tunnel symptoms which impacted both my work and fitness routine. Within months my LDL level did decrease… but so too did my HDL and triglycerides. My PCP said that the muscled pains and other side effects were miniscule compared to the long term benefits of the drug so I continued taking them but began doing some researching the issue.
I found that my LDL level was only high based on the new standards and that under the previous standards was considered ‘ok.’ I also discovered information about women, cholesterol, and the potential impacts of statins on childbearing. I decided that ultimately statins were not for me. I made the decision to stop taking the medication and alter my workout routine and make some small dietary changes. That alone has been enough to maintain a more appropriate LDL level for someone my age.
I think it is crucial that PCP who provide the only source of care for many Americans provide their patients with the pros and cons of these drugs and for a person like myself, (young, female, or average height and weights) offer other solutions for a slightly high cholesterol level.

I also find your article of great interest; my husband continues to suffer dire adverse effects from taking Lipitor 10 mg/day for 4 yrs. He was diagnosed with Parkinson’s disease in 2004. We discovered he possesses 2 SNPs in a gene, SLCO!B!, which encodes a transport protein that moves statins into the liver to be detoxified. For individuals who have one of these SNPs, research has found plasma statin levels much greater than normal–one study noted levels 134% higher than normal; another study noted a measurement , the AUC of statins to be 400% higher than normal for these individuals. The only studies done (by pharma) thus far have noted a greatly increased incidence in possession of one of these SNPs in individuals who develop severe myopathies and rhabdomyolysis while on statins. These SNPs are not rare; one , SLCO1B1*15, occurs in 26 to 32% of the caucasian population. the other, SLCO1B1*5 occurs in 5 to 6 % of the population (population genetic studies were done on Finlnish population–thus the caucasian statistics).
Imagine toxic levels of statins in the blood stream every day for 4 yrs. As the interruption of the mevalonate pathway results in greatly decreased cholesterol levels in the brain, depriving that organ of desperately needed sheathing for axons; interruption of synaptogenesis; decrease in growth of new neurons. Of great concern is the interruption of production of one of the major antioxidants of the body along with its primary role in production of cellular energy–coenzyme Q10. Interruption of the process which produces selenoproteins, again a major player in the antioxidant system, glutathione. Depression of isoprenylation of proteins. and other interruptions of normal biological substrates.

Everyone, thanks so much for your comments on this story. Please do share this post with others you think might be interested. If you want to carry on a more dynamic conversation, you might also consider visiting Altarum’s Facebook page and posting some comments that others can read and reply to.


Jonathan Orr
Editor, Altarum Health Policy Forum

I and my husband were both prescribed 20mg of a generic statin drug. He experienced muscle pain and cramps within 6 months and I also did 8 months later. We both are active and lift weights. But were told we had bad genes. We both eat healthy and stay active, but because of the magic number were put on the statin drugs. I fear going back to my doctor as we both quit taking the drug and complained of side effects. I suffered fatigue, some depression, sleepless nights and muscle cramps and pain in my legs. What should I do to avoid this drug??? I am more prone to believe the science than the magic wonder pills from the herbal supplement companies, but now who is really telling the truth on this issue.

for anonymous, the 23 yr old female who commented above: you may be interested the the article linked here: Evidence for Caution: women and statin drugs by Harriet Rosenberg and Linda Allard

In addition, Merrill Goozner, a science writer, has a blog with articles about statins archived which you might find instructive: the following is a link to an article about Crestor, the so called “JUPITER” trial which is now being cited as “proof” that statins help women,. The study showed no such thing.

Why didn’t Rochelle Sharpe disclose the name of the new statin medication that FDA approved to prevent druds?
Statins have been available since 1992 and have dangerous serious harmful ingredients that is causing many neeuropathy and rhabdomyolysis, yet a truthful ethical mandate reporting of adverse side effects is not available. MedWatch has not been successful and is not for immediate adverse side effects. Not only has statin medication made money for pharmaceuticals, medical profession and the health care industries, it also has contributed to the publishing industry. Writing, telling, informing is good, but the problems have not changed and the public is really not aware of the horrible harm and death fatalities of people taking statins.

I have been on statins for nearly 2 years. I have chronic pain in the muscles of my body and joints from the waist down. I recently discovered this could be because of the meds, but my doc reckons my weight is causing this. Until I took statins I was extremely fit. My memory and concentration is also seriously affected. Could I safely come off the statins? My life has become nothing but pain.

I am a female 67 years old. I was put on statins many years ago when my cholesterol was 7.5. I stopped taking them after about 6 years when my legs began aching whilst walking. Some years later, it was suggested I try them again and this time I came out in rashes and itching on hands and feet. Now my cholesterol level is 9.5 in spite of a low fat diet but I also have PMR and have just been diagnosed with Fibromyalgia which is ruining my life. I wish I had never been near statins.

I live in the UK, I am 44 years old and I do not take any medication, and I never have in the past other than the odd short course of antibiotics – and I would NEVER take statins.

Luckily in the UK we do not allow the drug companies to advertise on TV, but my brother who lives in the US is regularly bombarded with such nonsense drug adverts, using hack science to mislead an unwary audience.

There are literally layers and layers of bad information being promoted as science, but the data does not support the claims. The biggest scam is the fact that high cholesterol has never been shown in ANY reliable trial to be a reliable marker for heart disease, because it is a SYMPTOM of the condition NOT the cause. Cholesterol is a VITAL part of your body’s repair system, and when your cells need repair, your liver supplies more cholesterol to enable the repair. So a high cholesterol is merely an indicator that your body is in the process of trying to repair itself. So it is ludicrously stupid to take a statin drug which interferes with your liver’s natural ability to produce this vital substance.

Trials have shown that there are benefits to taking statins, but this is due to their anti-inflammatory effects, NOT as a result of the cholesterol being lowered.

All this appears to be a smoke screen to cover up the growing likelihood that the McGovern report in the 1960s urging all Americans to reduce fat in their diet (particularly saturated animal fat) was based on a tenuous link between cholesterol and saturated fat – but there were no proper studies that demonstrated this. Despite this, the government rushed through and presented the recommendation. This caused a huge growth in various industries selling “heart healthy” food based on this idea, which is now being shown to be completely wrong. But there is now a growing body of evidence that suggests that this very advice has been the MAIN CAUSE of the modern day rise in obesity, diabetes and cancer, because a diet low in fat is consequently high in carbohydrate.

Simply put, natural saturated fats are actually protective (as you would expect from something natural), but unnatural carbohydrates (particularly processed sugar, starches and grains) spike the blood sugar, cause excessive insulin levels, which causes many of the problems we see today – particularly obesity, because a body is unable to burn its own fat for energy while the insulin level is high.

The sad situation that Americans now find themselves in is this:

Most people still believe that a low fat, high carbohydrate diet is the key to a long healthy life – but this is not supported by the evidence. But government agencies are unlikely to admit they made a mistake in the 60′s because they would lose all credibility and never be trusted again. Therefore all the negative data gets ignored or buried.

Meanwhile, all the health problems caused by this bad health advice 50 years ago, is providing billions in revenue for the drug companies via statins. And big money buys a lot more bad science and mis-information to perpetuate the situation and keep the money flowing.

There is no clear way to resolve this issue, because a complete reversal of the low fat dogma would be catastophic to the economy – which is something I am sure many intelligent politicians worry about on a daily basis!

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