The Statin Fiasco
The new recommendations from the American Heart Association and the American College of Cardiology on the use of statin drugs to lower cholesterol caught my attention as a family physician. Not only were they recommending statins for patients with high cholesterol who had already suffered a heart attack or stroke or who had diabetes, but also for people without these risk factors. This was a game-changer.
I routinely prescribed a low-cost generic statin like lovastatin for all my patients with cardiovascular disease or diabetes with the goal of bringing their “bad” cholesterol (LDL-cholesterol) below 100 mg/dL or even lower, if possible. The scientific data was very clear that doing this helped prevent future heart attacks or strokes.
But the new guidelines also recommended statin therapy for patients without those risk factors if a new “Pooled Cohort Risk Assessment Equation” predicted their chances of having a heart attack or stroke as equal to or greater than 7.5 percent over the next 10 years. I decided to plug my own numbers into the equation to calculate my own risk.
I’m a 65-year-old white man who never smoked cigarettes, with well-controlled hypertension, no diabetes, and an LDL cholesterol of 100 without any medication. An LDL less than 130 is considered normal. My “good” cholesterol (HDL) is up where it should be—56. I thought this was a pretty low-risk profile. But lo and behold, the new risk calculator said I had a 10-year risk of 12.2 percent, thus putting me in the group that should be taking statins.
What really caught my eye, though, was a statement on the risk calculator that if a man my age had perfect numbers and no hypertension, his 10-year risk would be 8.8 percent. That means under this new set of proposed guidelines every man 65 and older should be on a statin!
That just didn’t make any sense to me. I looked up the three articles that had been cited as evidence for treating low-risk people with statins. All three studies were funded by drug companies that manufactured statins. In all the studies, patients had high cholesterol, and in one, the patients also had evidence of ongoing inflammation. So, in none of the studies did patients look like me.
I wrote to all of my physician colleagues in my community health center network and told them about what I had discovered. I told them that I was going to pass on starting on a statin and would be recommending the same for my patients in the same position.
The next day, front-page newspaper headlines reported that the groups recommending the new guidelines were now backtracking. It seems as if the new risk calculator may be way off the mark.
How could a group of such smart cardiologists not have seen what was so evident to me? Maybe the fact that half the cardiologists on the “expert panel” that created these new guidelines received payments from drug companies could have played a role? We know from social science literature that having such financial conflicts of interest can subtly and unconsciously affect judgment.
Now the cardiologists have egg on their face, pardon the bad cholesterol pun. Common sense has prevailed. But had these proposed guidelines been put into effect, billions of dollars more needlessly would have been spent on new prescriptions for statins. Millions of people would have been put at risk for developing possible complications from the use of statins, such as new-onset diabetes and muscle damage.
I hope the next “expert panel” that American Heart Association and the American College of Cardiology put together to come up with new guidelines will do a better job to prevent conflicts of interest from casting doubt on their recommendations for improving the quality of patient treatment. Recruiting cardiologists who aren’t getting paid by the drug companies that sell statins and relying on independent studies not funded by those companies would be two good places to start.
Stephen R. Smith, M.D., M.P.H., Community Catalyst physician consultant