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