When I was hospitalized after my heart attack, cardiologists immediately prescribed Lipitor, a statin drug which happens to be the biggest-selling drug on earth, made by Pfizer, which happens to be the biggest drug company on earth. My LDL (bad) cholesterol numbers went from 4.1 while still in the Coronary Care Unit down to 1.9 a few short weeks later.
(These are Canadian readings, by the way: to convert from Canadian to American readings, just multiply by 40). That’s quite a spectacular result for lowering one’s LDL cholesterol levels – but the question remains: do I really need to take this powerful cholesterol drug every day for the rest of my life?
Dr. Mark Ebell, a professor at the University of Georgia and deputy editor of the journal American Family Physician, says:
“High-risk groups have a lot to gain. But patients at low risk benefit very little if at all. We end up over-treating a lot of patients.”
He’s referring to over-treating patients with statins, the much beloved darlings of cardiologists everywhere – many of whom joke about adding statins to our drinking water. But are statin drugs good for us?
As Dr. Beatrice Golomb told the New York Times.
“You may have helped the heart, but you haven’t helped the patient.”
The associate professor of medicine at the University of California, San Francisco was the co-author of an editorial in The Journal of the American College of Cardiology questioning the current data on statins.
“You still have to look at the impact on the patient overall.”
If preventing a heart attack improved the quality of life, that would be an argument for taking statins even if the drug didn’t reduce mortality. But critics say there’s no evidence that statin users have a better quality of life than other people. Dr. Golomb explains:
“If you can show me one study that people who have a disability from their heart are worse off than people who have a disability from other causes, I would find that a compelling argument.
“But there’s not a shred of evidence that you’ve mitigated suffering in the groups where there is not a mortality benefit.”
In fact, major studies have come to the same conclusion: statins do not save lives. These include:
- a 2006 study in The Archives of Internal Medicine that looked at seven trials of statin use in nearly 43,000 patients, mostly middle-aged men without heart disease
- a study called PROSPER, published in The Lancet, that studied statin use in people 70 and older
- a review in The Journal of the American Medical Association that looked at 13 studies of nearly 20,000 women, both healthy and with established heart disease
Some patients do receive significant benefits from taking statins, like Lipitor (from Pfizer), Crestor (AstraZeneca) and Pravachol (Bristol-Myers Squibb).
In studies of middle-aged men with cardiovascular disease, statin users were less likely to die than those who were given a placebo.
But many statin users don’t have established heart disease; they simply have high cholesterol numbers. For healthy men, for women with or without heart disease, and for people over 70, there is little evidence, if any, that taking a statin will make a meaningful difference in how long they live.
The British Medical Association journal, Lancet, published a study by Dr. John Abramson from Harvard Medical School and Dr. James Wright from the University of British Columbia that questioned prescribing statin drugs routinely for those with high LDL (bad) cholesterol but who were otherwise at low risk for developing heart disease. Here’s what they wrote:
“Statins do help those aged between 30 and 80 who already have established heart disease, and for them their use is not controversial.
“But we found no clear evidence that statins work as a primary heart disease prevention tool for otherwise healthy women, or for men over the age of 69.”
The independent watchdog group called Therapeutics Initiative based at the University of British Columbia in Vancouver asked the question:
“Do the benefits of statins outweigh the harms in people without proven occlusive vascular disease?”
The TI team, who evaluate clinical drug trial data for doctors and pharmacists, found that five systematic reviews designed to answer this question about longterm statin use have been published in medical journals since 2003.
Unfortunately, these five reviews do not answer the question.
For one thing, none of the five reviews were Cochrane reviews. The Cochrane Collaboration is regarded as the gold standard of systematic reviews of published medical research. One of its guiding principles is avoiding unnecessary duplication: any independent reviewer following the proper methodology would include the same trials, extract the same data and come to the same interpretation and conclusions. The review is then updated as new trials are published.
Bu the five published systematic reviews that the TI team studied vary in the randomized control trials (RCTs) included, summary effect estimates, conclusions, and declared conflicts of interest of the authors.
Here are some of their alarming findings:
- Systematic reviews and meta-analyses are challenging and require much more than locating RCTs and plugging in the numbers.
- The claimed mortality benefit of statins for primary prevention is more likely a measure of bias than a real effect.
- The reduction in serious cardiovascular adverse events with statins as compared to placebo is not reflected in a reduction in total serious adverse events.
According to their findings, statins do not have a proven net health benefit in primary prevention populations, and thus when used in that setting do not represent good use of scarce health care resources.
What about the rave reviews after results of the famous JUPITER statin study were published in 2008? Since then, a number of cardiac researchers have criticized the study’s methodology and findings. See: When Medical Research is Funded to Favour the Drug, not the Facts
Great post, as usual. The statin makers are certainly raking in the sheckels on these drugs. I really feel for my doc, who tries very hard to do a good job of practicing preventative medicine. But I’m going to have a chat with him soon. Caveat emptor, once again.
I agree with Kathi. Even the most well-meaning doctor can’t help but be influenced by the powerful marketing machinery of Big Pharma and their drug rep teams. There’s only one reason these expensive marketing campaigns are launched – they work to sell more drugs.
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I am a 66 year old male with no history of heart disease in myself or my family. I started taking Lipitor about 5 years ago for “elevated cholesterol” (248). Soon I was experiencing fairly severe muscle pain. My shoulders, hands, hips, and knees, were the joints most involved. To alleviate the pain I was switched to Zocor, which worked for a time. When they raised my dosage to 40 mg., the same muscle problems began again. I stopped (on my own) taking the drug for six weeks and the pain essentially disappeared. The doctor said your cholesterol is back at 228 (it had been 180), better get you back on your meds. Five days later, I was in so much pain, I again stopped the medication. Two days later I was pain free. Now the doctor asked me to try Pravachol (80 mg.) Last night I took my first dose. Severe pain, and inability to sleep quickly followed. I was thinking about Zetia (a non-statin cholesterol lowering drug) but after doing some extensive reading, I think I’ll pass on trying to lower my cholesterol with drugs.
I know I’m late to the party. I want to comment about a failure of something in this post (and similar ones about statins).
This post starts off with: “When I was hospitalized after my heart attack” and then goes on to criticize statin use for people who DON’T have heart disease. There are two sentences related to people who have had heart attacks:
“Some patients do receive SIGNIFICANT [emphasis mine] benefits from taking statins, like Lipitor (from Pfizer), Crestor (AstraZeneca) and Pravachol (Bristol-Myers Squibb). In studies of middle-aged men with cardiovascular disease, statin users were less likely to die than those who were given a placebo.”
What does “significant” mean? For example, how much less likely to die are middle-aged men with cardiovascular disease, compared to someone taking a placebo? On average does that statin-taker live a month longer, a year? Five years? Does it take 1,000 men, or 10,000 middle-aged men with CVD taking statin drugs for 1 year, or 5 years, to keep one from having another heart attack or to die from a heart attack?
Without knowing what “significant” means, it’s difficult to know if there is any benefit. Yet I see this statement posted over and over and over again on blogs and in news reports – statins help those with CVD. But do they? How can we know if we can’t see the numbers. And I’m pretty sure neither the author of this blog, or any other, can come up with those number very easily.
If the numbers are available though, I’d like to know them. All I ever see is the claim that statins can help those with CVD.
Hello Dave – you’ve hit upon the dilemma precisely when it comes to “marketing-based medicine”. Studies on statins’ effectiveness for secondary prevention are actually relatively easy to find (for example, this comprehensive overview from the independent Therapeutics Initiative program at the University of British Columbia). But the key descriptor there is “independent” – the majority of statin studies are either funded by statin drugmakers, or conducted by researchers who have admitted financial conflicts of interest with Big Pharma, or in some cases, who hold patents on drugs like the much-touted statin-combo “polypill”. That doesn’t stop drugmakers from trying to educate our physicians to prescribe statins unnecessarily for primary prevention. As in all marketing efforts: “Just follow the money”.
Thanks for the fast response, Carolyn. That was very informative and what I was looking for.
For me, it seems like taking a statin might be worth the risk of side effects, because I had a heart attack.
From the 4S trial: “to prevent one definite MI and/or CV death, NNT (5 yrs) = 13).”
I had a heart attack in December, 2008. Despite a 100% blockage of my right coronary artery, I was able to ride my bike 100 miles in one day about three months after my heart attack. According to my cardiologist, though, I still had an area of approximately 70% blockage in my left coronary artery.
In fact, I needed two more stents eight months later, despite lots of exercise, healthy eating, and 40mg of Simvastatin a day, when I started experiencing angina pain. So for me, a statin didn’t work, at least not at 40mg, and despite my rigorous exercise and healthy eating.
Last March, my cardiologist decided to put me on 80mg of Simvastatin, to get my LDL down to 70mg/dl or less, on the theory that any remaining plaque buildup (estimated at 20% in a number of areas in my arteries) could be reversed. He switched me to Lipitor a few months ago, when I had muscle pain.
And the SATURN study that just came out seems to show plaque reduction might be possible for about 65% of the people who take Lipitor or Crestor. Which is why, if that study is correct, it might be worth it to keep taking my high dose of Lipitor.
I still have doubts, though that my reduction of risk for another heart attack with a statin outweighs the potential risk from side effects, like my muscle pain, dementia, rhabdomyolysis, etc. I guess that’s something for each person to have to decide – it’s good to make the decision with as much knowledge as possible.
is there any proof whatsoever that by punishing your body and becoming one of the millions of statin poisoned people, your plaque will reduce?
Regarding the word “significant,” this often refers not to the magnitude of the reduction but to the “statistical significance” — the probability that the reduction in events observed in the treated group as compared to the placebo group was caused by the statin drug rather than by chance. In general terms (glossing over subtleties here), a study is thought to show a statistically significant effect if there is less than a 5% probability that the risk reduction was the result of chance. Below 1% is considered a much stronger result.
I have read lots of statin studies. In primary prevention (no heart attack), and if you are a middle aged male, taking statins might lower your risk of a heart attack by 20% over a ten-year period, but the reduction in all-cause mortality is somewhere around 0% (one-side or the other). If you have had a heart attack (secondary prevention), risk reduction may be 25% to 35% (I suspect low side because of bias in the studies) for heart attack/events but all-cause mortality risk reduction is probably 8% to 15%.
Some things to note: First, statins have modest positive effects in specific situations, and it is not known whether these result from cholesterol reduction or anti-inflammatory effects. Regardless, one has so much residual risk that you need to look hard at other ways of protecting yourself (my focus has been raising my HDL from 40 to 60+, and nutrient sufficiency for magnesium, choline, selenium, Vit. D and Vit K-2). Second, side effects are much more common than is believed, and can be serious. So, overestimated benefits, underestimated side effects risks.
If I had had a heart attack, I would probably work hard to find a dose I could live with, but I gave up on statins due to side effects.
Thanks so much for your perspective here, Steven. Just this week we’re seeing emerging research on the “statistically significant” link between statins and diabetes. As a heart attack survivor, I can tell you that even statins’ well-accepted claims re secondary prevention can be troubling for us heart patients, given the pervasive Big Pharma financial influence on most major statin studies (e.g. JUPITER in 2008). See also: When Medical Research is Funded to Favour the Drug, Not the Facts.
Steven C. Root – that was an interesting comment. It seems from what you wrote that someone who’s had a heart attack – like me – can expect to have a 30% chance after ten years of not having another heart attack. That sounds pretty good.
And it seems that I have about a 12% chance of living longer if I’m on a statin after ten years, than not. That sounds pretty good, too.
On the other hand, there’s no way at present to know if eating healthy foods and exercising a lot doesn’t have the same or better beneficial effects on longevity than taking statins.
I do know, that at 64, I eat healthy foods and I can ride my bicycle 100 miles in a day. And I get muscle pain from statins. For now, I prefer not to take a statin, partly on the untested theory that what I am doing is as effective as taking a statin.
The question I ask myself is if taking a statin would confer an extra measure of potential protection from having another heart attack, in addition to the protection I might have from exercising and eating well. As drug companies won’t conduct such a study, I guess I’m experimenting on myself.