Statin drugs are the cholesterol-lowering darlings of contemporary medicine. So much so that fully half of men age 65-74 are prescribed them and one in four adults – both men and women – over 45 are taking them.
An increasing proportion of these patients don’t have the established cardiovascular disease for which statins were initially approved by the FDA. Indeed, despite unrelenting controversy over their widespread use and reported side effects, the latest statin guidelines expand their recommended use to another 13 million Americans – in many cases based solely on their age.
The statin controversy resurfaced anew with last week’s publication of statin study results suggesting that statin users are failing to follow a lower-fat diet, as suggested with their use. Indeed, this study found they’re actually consuming even more calories and fats than they did before being prescribed their statin drugs.
It isn’t clear how much of this is a direct result of the statins themselves and how much is due to patients slacking off because they feel immunized by virtue of the promised protections of their statin regimen.
Equally troubling as the 10% increase in calorie consumption that pushed the average weight of statin users studied from overweight into obesity was their over30% higher rate of type 2 diabetes.
If there is any cardiac protection provided by statins in the abstract, their benefits in actual practice would seem to be greatly offset by these adverse consequences. Obesity and type 2 diabetes not only contribute to cardiovascular disease, but to strokes and virtually all forms of cancer, among other disease complications.
Prescribing statins for those at risk for cardiovascular disease but with no history of it is called “primary prevention”, meaning the prevention of a first cardiovascular event. And here the evidence is less than compelling that these drugs provide any real benefit (Review Raises Questions About Statins for Primary Prevention).
This Cochrane Review raised troubling questions about the evidence base supporting the use of statins for primary prevention.
According to the report on this review at cardiobrief.org:
“The authors found ‘evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease.’ They concluded that ‘only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.’”
But there’s more to worry about than lack of benefit. Side effects include muscle pain, memory loss, and several other troubling side effects in addition to the longer-term complications like obesity and type 2 diabetes discussed above.
Watch this video from ABC News for more on these unwanted effects:
Yet the drive to expand the market for statins was refueled with publication of theJUPITER trialthat purportedly found significant benefit for patients with elevated markers of inflammation even with no history of cardiovascular events.
But take a look at the list of financial ties reported by the study’s authors as disclosed in theMedPage Today articlediscussing these “findings”:
“The JUPITER trial was an investigator-initiated project funded by AstraZeneca (manufacturer of the Crestor drug used in the study)….
“(Doctor) Ridker is the principal investigator of the trial and received grant support from AstraZeneca for its conduct. He has served as a consultant to Merck, ISIS, Vascular Biogenics, Boehringer Ingelheim, Abbott, and Genzyme; receives additional research grant support from Novartis; and is listed as a co-inventor on patents held by the Brigham and Women’s Hospital related to inflammatory biomarkers in cardiovascular disease and diabetes that have been licensed to Siemens and AstraZeneca. His co-authors reported relationships with AstraZeneca, GlaxoSmithKline, Merck, Novartis, Pfizer, ProNova, Sigma-Tau, Athera Biotechnologies, Carolus Therapeutics, Interleukin Genetics, and BIND Biosciences….
“Watts has received honoraria or lecture fees from AstraZeneca, Pfizer, Merck Sharp & Dohme, Sanofi, Amgen, Abbott, and Glaxo Wellcome.”
Are you starting to get the picture?
Have Doctors Swallowed the Statin Koolaid?
The Huffington Post posted an interview with Dr. Barbara Roberts, director of the Women’s Cardiac Center at the Miriam Hospital in Providence, R.I. and associate clinical professor of medicine at the Alpert Medical School of Brown University.
She spent two years at the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH), where she was involved in the first clinical trial that demonstrated a beneficial effect of lowering cholesterol on the incidence of heart disease. In addition to The Truth About Statins: Risks and Alternatives to Cholesterol-Lowering Drugs, she is also author of How to Keep From Breaking Your Heart: What Every Woman Needs to Know About Cardiovascular Disease.
Here are a few excerpts about the side effects and complications of statin use:
Martha Rosenberg: One patient you write about caused a fire in her home by forgetting that the stove was on. Another was a professor who experienced such memory loss on a statin he could no longer teach; others ended up in wheelchairs. The only thing more shocking than the side effects you write about is the apparent blindness of the medical establishment to them. Until half a year ago, there were practically no warnings at all.
Barbara Roberts: There is no question that many doctors have swallowed the Kool-Aid. Big Pharma has consistently exaggerated the benefits of statins and some physicians used scare tactics so that patients are afraid that if they go off the statins, they will have a heart attack immediately. Yet high cholesterol, which the statins address, is a relatively weak risk factor for developing atherosclerosis. For example, diabetes and smoking are far more potent when it comes to increasing risk.
Martha Rosenberg: In The Truth About Statins you explain pretty clearly how studies have made statins look more effective and safer than they are. How has this been done?
Barbara Roberts: First of all, the studies are of short duration, and some of them even have a “run in” phase during which people are given the drug to see if they tolerate it. If not, they are not enrolled in the study (this skews study results by understating adverse effects of the drug). Secondly, study subjects are cherry-picked to exclude the very elderly, people with liver or kidney disease or those with any chronic illness that might “muddy” the results —
Martha Rosenberg: In other words, the very people who will be taking them?
Barbara Roberts: Yes, and of course patients will also be staying on the drugs for life unlike trial subjects. Then, the data from the studies are usually given in terms of relative rather than absolute risk. The absolute risk of a cardiac event is only reduced by a few percentage points by statins and in some patients, like the women without heart disease we just talked about, the reduction is not even statistically significant.
In some studies surrogate endpoints like inflammation or artery thickness are used but a favorable change in surrogate markers does not always translate into clinical benefit. In addition, many studies use composite end points, which include not only “hard” end points like heart attack or death (which are pretty hard to misdiagnose) but also “softer” end points like the “need” for revascularization or the occurrence of acute coronary syndromes. For example, studies may be performed in many countries with very different rates of revascularization procedures, making use of this as an end point very problematic.
But you have to remember that medical journals depend upon Big Pharma for their ads and reprint orders just as medical centers and medical professionals rely on Big Pharma for funding. It is a round robin situation that probably won’t change until the patients, doctors and the public demand change (emphases added)
Other statin researchers have also reported on often unreported side effects of statin use. The following report outlines how clinical studies of statins are often structured so these side effects are under-reported in clinical studies and are therefore generally ignored by most physicians…
John Lynch: John Lynch was founder and CEO of Medical Diagnostics, Inc. - twice named to Business Week's "Best Small Companies" in America. He's since founded MedSmart Members to publish consumer health education publications.