The new cardiovascular-disease treatment guidelines released Tuesday by the American Heart Association and the American College of Cardiology is expected to significantly increase the number of American adults taking cholesterol-lowering statin drugs.
Indeed, under the new guidelines, about one-third of all adults in the United States would be advised to take statins. That’s because the guidelines have dramatically lowered the threshold for estimating a person’s risk of cardiovascular disease.
And that has some medical experts very concerned, although it was difficult to find their viewpoint yesterday among the generally enthusiastic media coverage of the new guidelines.
An op-ed from two of those concerned experts appeared this morning in the New York Times. It offers a different perspective on statins and heart disease — one that all of us should consider as we discuss these drugs with our physicians.
The authors are Dr. Rita Redberg, a cardiologist at the University of California, San Francisco Medical Center and the editor of JAMA Internal Medicine, and Dr. John Abramson, a lecturer at Harvard Medical School and the author of “Overdosed America: The Broken Promise of American Medicine.”
“We believe,” they write, “that the new guidelines are not adequately supported by objective data, and that statins should not be recommended for this vastly expanded class of healthy Americans.”
Here, in part, is why they have taken this position:
This announcement [of the new guidelines] is not a result of a sudden epidemic of heart disease, nor is it based on new data showing the benefits of lower cholesterol. Instead, it is a consequence of simply expanding the definition of who should take the drugs — a decision that will benefit the pharmaceutical industry more than anyone else.
The new guidelines, among other things, now recommend statins for people with a lower risk of heart disease (a 7.5 percent risk over the next 10 years, compared with the previous guidelines’ 10 to 20 percent risk), and for people with a risk of stroke. In addition, they eliminate the earlier criteria that a patient’s “bad cholesterol,” or LDL, be at or above a certain level. Although statins are no longer recommended for the small group of patients who were on the drugs only to lower their bad cholesterol, eliminating the LDL criteria will mean a vast increase in prescriptions over all. According to our calculations, it will increase the number of healthy people for whom statins are recommended by nearly 70 percent.
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 or 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 percent 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.
At the same time, 18 percent or more of this group would experience side effects, including muscle pain or weakness, decreased cognitive function, increased risk of diabetes (especially for women), cataracts or sexual dysfunction.
Redberg and Abramson also raise another concern:
The process by which these latest guidelines were developed gives rise to further skepticism. The group that wrote the recommendations was not sufficiently free of conflicts of interest; several of the experts on the panel have recent or current financial ties to drug makers. In addition, both the American Heart Association and the American College of Cardiology, while nonprofit entities, are heavily supported by drug companies.
The American people deserve to have important medical guidelines developed by doctors and scientists on whom they can confidently rely to make judgments free from influence, conscious or unconscious, by the industries that stand to gain or lose.
You can read the op-ed on the New York Times website.