In 2011, I appeared on the Dr. Oz Show with Dr. John Abramson of Harvard Medical School and we debated a number of issues including the value of statins to prevent heart attacks and strokes. Dr. Abramson took the view that statins are unnecessarily prescribed particularly in people without overt heart disease and who have not yet experienced a cardiovascular event. I defended the view that statins have saved countless lives. Dr. Abramson said that he often took his patients off statins and I was stunned by this. I turned to Dr. Oz and asked: “Dr. Oz, you’re a cardiologist, how do you prescribe statins?” He replied: “I am usually the one taking them off statins,” at which point the audience broke into applause.
I tell this story because as recently as four years ago there were those in the medical community who believed that statins like Pfizer’s Lipitor (atorvastatin)and Merck’s Zocor (simvastatin) were over-utilized and that patients should be trying to control their high cholesterol levels by exercising, losing weight and eating a proper diet. I certainly endorse doing all of these things before turning to any medication, including statins. However, despite attempting these lifestyle changes, many (including myself!) need a statin to bring their LDL cholesterol (LDL-C) to recommended levels.
Two years later the American Heart Association and the American College of Cardiology jointly issued new cholesterol guidelines as to who should be taking statins. Three of the four proposed guidelines were generally accepted such as statin use for those who had atherosclerotic heart disease, those with LDL-C levels higher than 190 mg/dL, and diabetics with LDL-C from 70 through 189 mg/dL. However, the fourth proved controversial: patients aged 40 through 75 years without clinical atherosclerotic cardiovascular disease and diabetes, but with an LDL-C level of 70 through 189 mg/dL AND an estimated risk of heart disease in the next decade of 7.5%. This was a dramatic lowering of the bar for treating people who had not yet developed heart disease.
Not surprisingly, Abramson was outraged and expressed this in a New York Times op-ed piece co-authored with Dr. Rita Redberg:
This may sound like good news for patients, and it would be – if statins actually offered meaningful protection from our No. 1 killer, heart disease; if they helped people live longer and better; and if they had minimal adverse side effects. However, none of these are the case.
Statins are effective for people with known heart disease. But for people who have less than a 20% risk of getting heart disease in the next 10 years, statins not only fail to reduce the risk of death, but also fail even to reduce the risk of serious illness – as shown in a recent BMJ article co-written by one of us. That article shows that, based on the same data the new guidelines rely on, 140 people in this risk group would need to be treated with statins in order to prevent a single heart attack or stroke, without any overall reduction in death or serious illness.
Two new papers in the Journal of the American Medical Association provide data that disprove Abramson’s assertion. As summarized in an editorial entitled “Cholesterol Lowering in 2015 – Still Answering Questions About How and in Whom,” authors Philip Greenland and Michael S. Lauer discuss the implications of these studies, suggesting that “the new risk threshold is likely to be reasonable and cost-effective.” The first study had 2,435 participants taken from the Framingham Heart Study who had been not been on statins but had been tested for coronary artery calcium between 2002 and 2005 and had been followed up for a median of 9.4 years for incident cardiovascular events such as heart attacks and strokes. It was then determined which people would have been eligible for statins under the new guidelines and under the old guidelines. As critics of the new guidelines have stated, many more of the 2,435 were eligible for statins under the new guidelines (39%) than would have been under the old guidelines (14%). But, after 9 years, there was little difference between the two groups in terms of incident cardiovascular disease: 6.3% of those eligible for statins under the new guidelines vs. 6.9% of those eligible based on the old guidelines. The new guidelines indeed identified people who were likely to have a cardiovascular event as well as the old. This study essentially validated statin use for people with a 7.5% risk of having a heart attack or stroke over the next 10 years.
Critics next turn to the cost implications of millions of more people taking statins and the burden this places on an already taxed healthcare system. However, the second study in JAMA dispels this as well. Given that statins are now generic with annual drugs costs per patient of less than $70/year, despite the larger numbers of patients projected to be on statins, the new guidelines are both life-saving and cost effective. As stated by Greenland and Lauer:
Available evidence indicates that statins are both effective and cost-effective for primary prevention even among low-risk individuals. Although lifestyle interventions must be employed across all segments of the population, for many people a statin drug will also be required to minimize risk.
My guess is that pharma-skeptics like Abramson will continue to rail against these new guidelines. They will undoubtedly challenge that the people who devised the guidelines had a conflict of interest due to associations with pharmaceutical companies (although none of the authors on these papers had any such conflicts). They will likely worry that millions of Americans are being unnecessarily exposed to drugs with serious side-effects (although ALL drugs including aspirin and acetaminophen have serious side-effects). However, Greenland and Lauer put this into great perspective:
There is no longer any question as to whether to offer treatment with statins for patients for primary prevention, and there should now be fewer questions about how to treat and in whom. Rather, the next phase of research should be directed at better ways of applying lifestyle and drug treatments to the millions, and possibly billions, worldwide who could potentially benefit from a cost-effective approach to primary prevention of atherosclerotic cardiovascular disease.
Statins are remarkable drugs in the war against heart disease, the world’s leading killer. It’s time to incorporate them more broadly in healthcare.
(The author is the former head of R&D for
