You can thank The Guardian (the most frequently cited source in the articles I have read) for promoting what is essentially bad science that has unfortunately influenced decision-making bodies to release new guidelines that will subject millions more people to the actually very well-documented bad side effects of statins. I'll get to the documentation of the side effects shortly. Let's talk about how bad the science behind the study really is.
Dr. Ben Goldacre, one of the authors of the study, recently wrote on the Bad Science blog that the study has been badly misrepresented in the media. Dr. Goldacre immediately disputes the sensationalist media headlines and then launches into an explanation (and defense of) the Placebo Effect. Any responsible medical researcher knows that people who take sugar pills -- who think they are taking a medicine -- may experience symptoms similar to the "side effects" reported by people taking actual medicines. We can therefore safely and reasonably conclude that on any given day some random percentage of people are going to experience dizziness, headaches, nausea, etc. for no apparent reason. Some of those people will undoubtedly be participating in clinical trials or actually taking real medications.
Having established that there are indeed patient misconceptions about side effects, Dr. Goldacre goes on to burn a hole in the credibility of the study he co-authored:
And that brings me to the central flaw in our study. As we say in the text, the side effects information we were able to work with, from trial publications, is likely to be incomplete: the trial reports varied in what side effects they reported, they often failed to describe their methods for spotting and reporting side effects very well, and companies may not be highly motivated to put a lot of side effects data into their academic papers (to say the least)."...likely to be incomplete" data is the stuff of which bad science nightmares are made, is it not? I have to deal with people who draw random wild conclusions on the basis of incomplete data in Web marketing almost every day. I expect that from a non-scientific community. But the "professional journalists" of the news media are supposed to know better than to pluck something out of a scientific paper and run with it until everyone on Earth believes absolute nonsense. At least, that is what journalists have been saying for years to distinguish themselves from untrained bloggers who pollute the Internet with all sorts of unvetted "(s)information".
Dr. Goldberg wanted to amend the paper that has caused all the fuss but his proposed amendment was not included in the published paper. He writes on the Bad Science blog:
Comparison with real-life clinical experience
Many real-world patients report muscle-related symptoms with statins. This contrasts with the low placebo subtracted rate in blinded trials shown in this meta- analysis. Several explanations are possible. First, commercial sponsors of clinical trials may not be motivated to search exhaustively for potential side effects. One pointer towards this is that, although liver transaminase elevation was documented in the majority of trials, new diagnosis of diabetes was only documented in three of the 29 trials. It is also likely that side effects data is collected, but not reported in the academic paper: a recent study by IQWiG, the German government’s cost effectiveness agency, found complete information for 87% of adverse event outcomes in the standard lengthy regulatory document for industry trials (the Clinical Study Report) but for only 26% of adverse event outcomes in the journal publication [Wieseler 2014]. Second, many trials do not state clearly how and how often adverse effects were assessed….
Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data. PLoS Med. 2013 Oct 8;10(10):e1001526.
So the science is now starting to look better; unfortunately, this is not the science that was so extensively covered by the news media.
As a Type II diabetic and a former statin patient, I have first-hand experience with the incomprehensibly disastrous side effects that statins produce in many patients. I normally don't share details of my personal life but I think it's important to share here, and now, what I went through. In fact, I normally don't share details of my intimate life but I think it's important to stress just how easy it is to test oneself for (in)tolerance to statins.
As I move around every few years I have been treated by several doctors across the United States. I am very confident they were all competent, well-informed doctors. They certainly took the time to listen to my complaints and to ask probing questions to try and determine if I might be mistaking statins as the causes of my symptoms. Not too coincidentally, all those doctors told me they had heard many similar complaints from other patients they had put on statins.
As best I can recall off the top of my head, I have tried Zocor, Zetia, Crestor, Lipitor, Prevachol, and maybe one or two others. I generally experienced the same icky results with all of them, except Zetia. Zetia took the top prize for worst medicinal experience of my life.
When I look at Websites that list statin side effects most of them talk about diabetes and elevated liver enzymes. I already had those problems. Maybe the statins made them worse. Maybe not. I have no intention of finding out. What the statins did to me (besides NOT lower my bad cholesterol very much) was introduce me to the world of Restrooms and Bathrooms (Loos for our friends across the pond). The gastro-intestinal irritation that statins cause is very real, very uncomfortable, and for some people almost completely unmanageable.
In that respect I am lucky. I always made it to the proper facilities in time and I never had to call home for a change of clothes. Other people have not fared so well. The statins don't just clean you out -- they gouge a hole in your metabolic system so that you spend hours in agony with unexpected gas, nausea, cramps, and diarrhea. There is no rhyme or reason to the order in which the symptoms occur. It's like if your body runs out of fluids and solids to torture you with for one symptom it changes gears and finds another way to make your life miserable.
How do I know these symptoms were caused by the statins? Look at the list of statins I tried to take. Sometimes I took these medications two or three times in a row -- always stopping and waiting for a few weeks for the symptoms to abate. The doctors understood what I was going through because my experience was far from rare. You could see in their tired expressions that I was about to walk a long, dark path through rotating treatments in a vain hope of finding some statin I might be able to tolerate for some length of time.
After playing Statin-of-the-Month for a couple of years I finally decided that the Physician's Desk Reference and Current Therapy aren't all they are cracked up to be. To be honest, the last doctor to agree to let me stop taking statins looked almost as relieved as I felt. I think he was hearing too many complaints from patients, watching too many people suffer in agony with no real relief.
Oh, the Zetia? Yeah, I developed that muscle weakness that supposedly is non-existent. I went from being able to run uphill in Seattle to having to clutch on to fire hydrants and cars just to walk 1 city block on a gentle incline -- in a week. My girlfriend thought I was faking. I barely made it back home and she had to help me. I went to the doctor the next day and he had me stop the Zetia and looked for muscle damage. Fortunately he found none.
When I finally thought to search the Internet a few years ago I found Web forum after Web forum filled with people complaining about all of these symptoms from taking statins. How is it, I asked myself, that these people are perfectly willing to talk to strangers about their horrible statin-related symptoms, but medical researchers cannot find them? I understand that anecdotal evidence is not reliable for a scientific study but if you need to track people who are actually using drugs and those people are reporting symptoms, with the right grant you should be able to put together a team that can track down people, get the proper authorization, and start tracking some real statin users.
A few years ago I found one doctor who wrote on his blog that fully 25% of his statin patients had to stop taking the drugs because they couldn't tolerate the symptoms. Unfortunately I don't have that old blog article bookmarked but I did find this article from 2013 that documents how many statin users stop taking the drugs.
UPDATE: Another article published on June 11, 2014 offers a more credible point of view: Statins will not help 80% of patients currently taking them; and in clinical trials 12,000 of 32,000 (37.5%) of patients could not tolerate the statins and so their data was not used in the final report.
The last time I tried to take statins was about two years ago, maybe slightly longer. My girlfriend again didn't believe I was having so much trouble. Without my knowledge she slipped a food supplement into some of my meals, red rice yeast extract. We had heard that this traditional Chinese medicine had been shown (by western science) to have cholesterol-fighting capabilities. I joked to her that maybe I should try that instead of all the processed drugs. I never thought I would actually try it.
After three days of suffering through statin-like symptoms I complained to her that I didn't feel like going in to work. When she asked why she had a funny look on her face. That was when I learned I was taking very small doses of a natural statin. Her skepticism was permanently cured and I haven't touched a statin since then.
Yes, my "bad" cholesterol is still bad but I can manage my triglycerides by walking up to 2 hours a day and I can keep my blood sugar under control by eliminating most breads, starches, and sugars from my diet (and walking 1-2 hours a day). I do take a medication to help control my blood sugar, which is near normal levels.
So I was appalled to learn that the American Heart Association and the American College of Cardiology are proposing that even more millions of people be made to suffer through the intolerable experience of "finding the right statin". These people are clearly making decisions on the basis of bad science. To date not one independent study has shown that statin use is reducing deaths due to heart disease.
Yes, there are plenty of studies that suggest statin use MAY have saved lives -- but how do you prove those people would have died from not having the statins? Medical researchers and doctors are arguing about this; and yet the guideline writers are ignoring the cries of the patients.
I propose that anyone writing guidelines for prescribing unproven life-saving medications first take those meds themselves. After experiencing what the patients experience for two or three years, THEN let the guideline writers make those suggestions. I may die of a heart attack tomorrow -- I certainly hope that doesn't happen -- but there is no scientific data that convinces me returning to statins will reduce the chances of that happening.
And, frankly, if such data did exist I would not take the statins anyway. I was fortunate enough to be treated by a lipid clinic for a while; they even looked at my arteries for cholesterol buildup. Despite the fact my numbers are high enough to cause concern they found no indication of any buildup. Call me lucky or whatever, but I take that as a sign that I still have time to find some other way to manage my risk factors.
My blood test results may not be perfect but at least I don't have to think in terms of how close the nearest restroom is and how clean it may be. If you have never lived through that, even for a week, you cannot imagine what a life-changing decision it is to walk away from statins and their non-existent side effects. It's a HUGE decision -- a fully positive one in my experience. For now I am eating far fewer french fries, hamburgers, and hotdogs than I used to.
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