Are Statins Overprescribed?

Does it really make sense to put a large group of people on a drug whose effectiveness hasn’t been proven for that group?

What at first looked like a creeping increase in statin prescriptions is turning into a gallop. Despite the significant and life-altering side effects that this class of cholesterol-lowering drugs can cause, the USPSTF (US Preventative Services Task Force) is likely to approve a broadening of the group of adults for whom statins are recommended — without including a recommendation to try lifestyle changes to lower cholesterol first.

The USPSTF is proposing that any healthy adult between the ages of 40-75 with no history of cardiovascular disease (CVD), but whose 10-year risk of stroke or heart disease, and who has at least 1 risk factor, take statins.

The draft recommendation (it’s not yet approved) adheres closely to the guidelines put out jointly in the fall of 2013 by American College of Cardiologists/American Heart Association. Estimates at the time were that it would double the number of people on statins from 25 million to up to 56 million people.

That’s a lot of people to put on a medicine that has been linked to diabetes, muscle damage and cognitive impairment but hasn’t proven its effectiveness in this group.

What Happened to Lifestyle Changes?

Worse, the recommendation didn’t even consider non-pharmaceutical options as a first choice. Exercise, weight loss and/or dietary changes have been proven effective at lowering risks of CVD. As MedShadow reported last fall:

And yet, if more people followed a heart-healthy lifestyle, many of them would not need the drugs. David L. Katz, MD, author of Disease-Proof, believes that “if lifestyle were used as medicine, 80% of all heart disease could be eliminated, no prescription required.” He adds, “Using medication is not nearly as good, and yet we tend to neglect the power of lifestyle as medicine and rely on meds.” (MedShadow, “Statins: How Safe Are These Life-Savers?“)

Statins have both substantial benefits and risks. They can help prevent a heart attack or a stroke, but may also increase the risk of diabetes and muscle damage. In a study published in 2015 of statin drugs given for 5 years for heart-disease prevention to healthy adults, no lives were saved but 1% developed diabetes and 10% suffered muscle damage. Benefits were that 6% avoided a heart attack, and just over 9% avoided a stroke. A 2013 study in BMJ showed a 9% increased risk of diabetes when using statins. The risk might well be different with each type of statin. This is a good point to discuss if your doctor is recommending statins.

A layperson might look at preventing a (nonlethal) heart attack or (nonlethal) stroke as “better” than getting diabetes. That’s a personal decision best made between the patient and doctor. However, diabetes should not be underestimated simply because it is becoming more common. Diabetes is a chronic disease that can lead to heart disease, stroke (do we get the irony here?), vision loss, kidney failure, amputation of toes, feet or legs, and premature death.

Factoring in Side Effects

Statins have also been linked to liver damage and cognitive impairment, with conflicting research on the subject. An article in MPR explores the link between statins and depression and explains why this would make sense.

Valsartan Recalls: 3 Key Facts

Medshadow Staff

MedShadow is a member of the Patient, Consumer, and Public Health Coalition (an informal coalition of nonprofit organizations representing the interests of patients, consumers, health-care professionals, scientists, and public health experts) who sent a letter to the USPSTF stating:

We are also concerned that statin trials have not included sufficient numbers of women, seniors, and racial and ethnic minorities, and have not analyzed safety and efficacy separately for those subgroups. The task force notes that “a majority of participants were male and white.” And yet, the task force’s recommendations are for all adults 40 to 75. It is inappropriate for USPSTF to assume that data based primarily on white males would be the same as data for women and people of color.

Does anyone pay attention to USPSTF recommendations? Individual doctors continue to have discretion as to what they discuss with their patients. However, the ACA (Affordable Care Act) requires that health insurance coverage include (without any “cost sharing,” which I believe means co-pay) any recommendation that receives and A or B grade by USPSTF. Medicaid and Medicare are exempt from that requirement. The recommendation carries a “B” grade from USPSTF.

The combination of insurance coverage and a recommendation from USPSTF, the ACA and the AHA might well be enough to push internists and family practitioners to prescribe statins in borderline cases. If you do not have heart disease but do have a risk factor (such as smoking, being overweight or having a family history of heart disease), discuss all your options with your health care provider. And please consider how your medical choices will affect your entire life — changing your diet and taking a walk every day have beneficial side effects for every aspect of your life. Taking statins is easy, but comes with a cost.