I’m sure you’ve heard by now that the leading heart organizations in the U.S. have released updated treatment guidelines for cholesterol-lowering drugs (statins). The changes include discarding the specific numerical targets that have been used to monitor treatment for decades and recommending a statin for everyone with a 10-year risk of heart attack or stroke of 7.5% or higher, as determined by a new risk calculator.
The new guidelines have received a lot of media attention of the past several days, including criticism from no less than the former president of the American College of Cardiology. I’m happy to see this, because as I will argue in this article, the new guidelines are problematic and would put millions at risk due to unnecessary and prolonged treatment with statin drugs.
Here are 3 reasons why you should be skeptical of the new cholesterol and statin guidelines.
#1: They dramatically overestimate risk
Two Harvard Medical School professors, Dr. Paul M. Ridker and Dr. Nancy Cook, have pointed out that the new risk calculator overestimates risk by 75 to 150 percent, depending on the population. (1) For example, a man whose risk was actually 4 percent might show up as having an 8 percent risk—which would move him from the “no treatment recommended” group to the “prescribe a statin” group.
Dr. Steven Nissen, a former president of the American College of Cardiology, entered information for some hypothetical patients into the new risk calculator to see what it would recommend. He was shocked to find that the calculator showed a risk of 7.5 percent for a 60 year-old healthy African-American non-smoking male with no risk factors, a total cholesterol of 150, HDL of 45, and systolic blood pressure of 125. He also found that the calculator suggested a risk factor of 7.5 percent for a 60 year-old healthy white male with no risk factors. If we use this new calculator, Dr. Nissen said, it would lead to almost all healthy men over the age of 60 getting treated with a statin, even if they’re in the lowest-risk group. (2)
#2: They’re based on flawed, incomplete, or outdated evidence
In an excellent paper in the journal Mayo Clinic Proceedings, Dr. Allan Sniderman and colleagues argue that so-called “evidence-based medicine” is problematic because of limitations in the evidence used as the basis of treatment guidelines and recommendations. (3) As an example, he points to the role of statins in primary prevention (i.e. prescribing statins to healthy people without pre-existing heart disease as a means of preventing it). Most doctors now believe that the highest doses of statins are the best choice solely on the basis of a single meta-analysis (an analysis of several individual studies) that involved 5 dose-comparison studies. However, as Dr. Sniderman points out, the meta-analysis is flawed and does not support the conclusion that higher doses of statins are more effective than lower doses for prevention of heart disease in healthy people.
Another problem is that treatment guidelines are often based on outdated evidence. This turns out to be the case with the new risk calculator, which uses data from studies performed two decades ago to determine how risk factors like cholesterol and blood pressure predict actual heart attacks and strokes later in life. Data from these studies are no longer valid because the participants are from a different era with different behaviors and risk. For example, in the early 1990s more people smoked and heart attacks and strokes occurred earlier in life.
#3: They’re subject to conflicts of interest
Numerous studies have shown that conflicts of interest are a real problem in scientific research. (4) According to Lisa Cosgrove, an associate professor at the University of Massachusetts, “When individuals have commercial ties they are vulnerable to developing subtle, but sometimes powerful, pro-industry ways of thinking.” (5) Dr. David Antonuccio put it even more plainly in his excellent article “Antidepressants: A Triumph of Marketing Over Science”:
Company-sponsored experts, whether they are researchers or educators, are by definition company employees. They will be retained only if they offer consistently favorable treatment to the company’s products.
This explains why groups like the Institute of Medicine recommend minimizing or eliminating conflicts of interest in guideline development groups. They wrote that, “whenever possible, guideline development group members should not have conflicts of interest… and the chair or co-chairs should not be a person(s) with conflicts of interest.” (6)
The American Heart Association and American College of Cardiology did not follow the sensible recommendation of the Institute of Medicine when they assembled their expert panel. Of the 15 panelists that authored the new guidelines, 6 reported having recent or current ties to pharmaceutical companies that sell or are developing cholesterol-lowering medications. Among the companies listed are Merck, Amgen, AstraZeneca, Pfizer, Amarin, Roche, and Abbot Laboratories. (For a full list of disclosures, see page 51–57 of the new guidelines.)
Strangely enough, I’ve seen some people criticizing the idea that conflicts of interest would affect statin prescriptions because most statins are no longer protected by patent are thus not profitable for drug manufacturers. Nothing could be further from the truth. Over the past 5 years, statin prescriptions in the U.S. have grown 20 percent to 264 million a year (a shockingly high number in a country with a population of 314 million). Total global sales of cholesterol-lowering medications, including statins, were $35 billion in 2012. Statin sales amounted to $29 billion worldwide and $10 billion in the U.S. (7) Those are enormous figures. In fact, statin drug sales account for approximately 10% of all drugs sold in the U.S., with a single statin (Lipitor) generating almost $8 billion in sales alone. (8) I think it’s pretty safe to say that drug companies are making a killing selling statins.
30 years ago the then-CEO of Merck (Harry Gadsen) told Fortune Magazine that he wanted Merck to be more like chewing gum maker Wrigley’s. It had long been Gadsen’s dream to make drugs for healthy people so that Merck could “sell to everyone”. (9) If implemented, these new cholesterol guidelines would certainly help Gadsen’s vision to become a reality.
Fortunately, it appears that the guidelines as currently designed won’t be accepted due to serious flaws that have been pointed out by leading cardiologists around the country. In the meantime, if you’re wondering what to do (or not do) about high cholesterol, make sure to read my recent series called The Diet-Heart Myth.