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What you don’t know can hurt you

DRUG BUST by Alan Cassels

The people’s briefing note on prescription drugs

Portrait of columnist Alan Cassels
• 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.

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

6 comments

  1. Ed Terry /

    Back in 1980, according to the pharmacology textbook I used in Pharmacy school, a normal cholesterol level was “200 + age”. After statins became commonly used, “normal” was re-defined by the pharmaceutical industry.

    There’s also never been a valid study demonstrating that lowering LDL has any effect on heart disease, which makes sense since LDL cholesterol is not the cause of heart disease. Common causes of heart disease are infectious agents and chronic inflammatory conditions.

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  2. beauty ncube /

    i have been started on cresta tablet,and i have been experiencing the above symptoms.I am always feeling tired and i have become breathless something that has never happened to me.Thank you for the information,because i have been wondering about what is happening to me.

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  3. Multi-medicated father

    My interest in health care and medications started in 2003.

    My father had spent one week in a nursing home and returned to his home in a terrible state. I, immediately, suspected drugging.

    He had numerous medications before this visit (without evaluation for years) and, now, he had received another two – Mellaril and Aricept (neuroleptic and medication for dementia).

    There was no information what-so-ever, neither verbally nor in writing, and I was of the opinion that my father was suffering from poly-pharmacy and from side effects of other medications rather than dementia.

    I had just got Internet and started to look for information.
    It did not take long before I realised that Mellaril was withdrawn in England due to serious heart arythmias etc.
    In Sweden it was prescribed for another year.

    That`s how it is.
    One country finds a certain medication good, another that it`s deadly.

    When my mother told a visiting nurse that I had found this information she sent a message to me – you should never believe in what you find on the Internet!

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  4. Simvastatin – my mother

    Thanks a lot for your interesting book Seeking Sickness.
    I also liked Selling Sickness.

    Unfortunately, there are very few critical books on these subjects here in Sweden, books which are meant for the general public. The publishing companies are not interested in publishing/translating as this kind of books don´t get the media attention they need to produce bestsellers (mostly thrillers etc.).

    In 2004 my mother suffered from cramps, pain and weakness in her legs. She also had sleeping problems. Her doctor had prescribed sleeping pills for a very long time.

    My mother phoned him wondering if there could be any connection to her blood pressure medication (metoprolol). His answer was – no – and the conversation ended.

    He knew that my mother also took the cholesterol-lowering drug simvastatin and aspirin.

    One day I visted the library and happened to see the front of a health magazine. It was a special cholesterol issue. I was surprised to learn that there were doctors/scientists that disagreed with the Cholesterol Hypothesis and I visited their site – thincs.org.

    The head of the network had a Scandinavian name – Uffe Ravnskov.
    It turned out that he was Danish but lived in Sweden since many years.
    He had also written a book.

    I read it and, together with other information, realised that my mother`s health problems could be side effects of simvastatin.

    I found medications.com, spacedoc.net, askapatient.com and peoplespharmacy.com and I read patient stories – many similar to my mother`s.

    I became a member of Public Citizen (worstpills.org) and received there monthly newsletters about medications (still do).

    My mother`s doctor was more interested in following the national treatment plan than listening and taking care of my 84 year old mother`s health problems.

    She did not want me to interfere because her doctor was so kind and he also took simvastatin. Therefor, it must be something good.

    I gave her Uffe Ravnskov`s book and also a letter that I had received from him.

    I translated one American patient story after the other and then I left it. It was up to her.

    Eventually she stopped simvastatin gradually.
    She turned 92 this spring and still lives an interesting and independent life.

    P.S.

    Uffe Ravnskov has written many books since then. Some have been translated into English, Spanish, Finnish etc. I am sure you will find lots of information if you google his name.

    Here are some other critical voices – Duane Graveline, John Abramson, Joel M. Kauffman, Malcolm Kendrick, Shane Ellison, Anthony Colpo, Barbara H. Roberts, H. Gilbert Welch and Shannon Brownlee. I am sure there are many more.

    I am so glad there is the Internet!

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  5. Simvastatin – lady in her seventies (=A)

    A suffered from a reasonably mild stroke.
    For the first time in her life she was ordered to take lots of medications, but within a year she had stopped most of them because she did not feel fine and her common sense told her that this was not the way to improve.

    A had some help in the home and, now and then, a nurse used to visit.

    One day she asked the nurse for some help.
    She wanted her to tell the doctor that she did not want to take simvastatin any longer.

    A felt that her problems with sleep and memory might be side effects of simvastatin. She also suffered from cramps in her legs.

    The nurse refused.
    She told A that she was playing Russian Roulette with her life and that she would end up in a wheel chair or die.

    Eventually A improved and went to the health clinic.
    She told the doctor that she wanted to stop and he acted exactly in the same manner as the nurse. He did his best to scare A to obedience.

    But, A told him – this is my own decision, please make a note in my journal and I also want you to report my side effects to the medical authorities.

    He responded – why should I do that?
    No-one has ever asked me to do such a thing.

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  6. Diagnosis and Prescription Cascade
    Multimedicated man (=X)

    X suffered from a fall and took anti-inflammatory drugs (NSAID) for a long time.

    He started to bleed from his stomach.
    The NSAID:s continued.

    He got a heart attack and the list of medications became considerably longer (aspirin, metoprolol, simvastatin etc.).

    X complained of sleeping problems and pains/cramps in his legs.
    They would come suddenly and became worse and worse.
    He asked if it could be side effects, but was told – no.

    He also had muscle weakness and problems with hips and hands.
    He was diagnosed with RA (Rheumatoid arthritis?)
    More medications were added – Imuran and prednisolone.

    X put on weight and was told he was prediabetic (2).
    He got a prescription for Metformin.

    He felt dizzy and was told that it was due to muscle stiffness in his neck and that he should visit a physiotherapeut. He did not improve.

    His big toe became red, swollen and very painful.
    It was gout and he was prescribed Glucophage (=allopurinol).
    After some time the toe improved but the medication was still to be taken. It went on for years. According to the doctor it was better to continue because if X stopped, the gout would, most likely, return.

    X had another heart attack , but they were not 100% sure.
    He received more blood pressure medications such as diuretics (spironolactone, furosemide) and ACE-inhibitors (enalapril).

    Suddenly X got a letter that there was something wrong with his white blood cells – trombocytopeni (exuse my English).

    He had problems with heart arythmia and was adviced to go through some electric procedures but did not improve.
    He was put on warfarin and had to do regular blood tests.

    He lost his taste, got blisters on his legs, became depressed and his memory, which had been fantastic, started to deteriorate.

    He got wounds on one foot and they would not heal.
    He had to take one antibiotic after the other, for instance quinolones.
    He had to have the leg plastered to his knee. It took a very long time before the wound was better, but it soon appeared again and more antibiotics were added.

    He became confused and was prescribed Risperdal

    X was suffering from heart failure and was prescribed digitalis (Dixocin?) by a doctor who disappeared after one week. X saw spiders in the corners of his bedroom and was very upset.

    When I first got to know X he had been a healthy person for his age.
    He used to take 45-minute walks to and from his work. His memory was amasing.

    But within a 10 year period his health was ruined. He aged prematurely and passed away shortly before his 75th birthday.

    X and I used to trust the health care staff but eventually my eyes were opened, thanks to the Internet (patient stories etc.) and the critical books that I found there. I tried to help X, by questioning his medications, but without success. He passed away shortly before his 75th birthday.

    I am totally convinced that some of his symptoms (diagnosis) were actually side effects of medications.

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