Harvard researchers say they have found significant problems with newly released guidelines on cholesterol and heart disease risk. The two associations that created them stand behind the guidelines, saying they’re just that—guidelines.
It was enough to give the medical world heartburn.
Barely a week after the American Heart Association (AHA) and the American College of Cardiology (ACC) jointly released cholesterol guidelines and a calculator tool for assessing heart disease risk, researchers have raised questions about the methodology used to develop them and their accuracy—leading to an emergency meeting and a strong defense of the report by the two groups.
“We stand behind our guidelines, the process that was used to create them, and the degree to which they were rigorously reviewed by experts,” said AHA President Mariell Jessup, M.D, in a statement issued jointly with ACC on Monday.
About the report: On November 12, the groups released the “AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk,” and debuted a downloadable calculator designed to help doctors predict individual patients’ risk over the coming decade. The guidelines encourage treatment with higher doses of statin drugs for several groups: patients who have heart disease, patients with high levels of LDL (“bad” cholesterol), and those ages 40 to 75 who have Type 2 diabetes or an estimated 10-year risk of heart disease of 7.5 percent or higher. This contrasts with previous treatment recommendations that combined lower doses of statins with other cholesterol-lowering drugs. “Considering all the possible treatments, we recommend a heart-healthy lifestyle and statin therapy for the best chance of reducing your risk of stroke or heart attack in the next 10 years,” Dr. Neil J. Stone, who chaired the panel that came up with the new guidelines, told CBS News.
Researchers raise doubts: Days after the calculator was unveiled, Harvard Medical School professors Dr. Paul Ridker and Dr. Nancy Cook raised concerns about it and the new guidelines. In an analysis that used the calculator to assess risk of volunteers in three major medical studies, the researchers had found that the calculator overestimated the number of people who might need the drugs, while potentially giving the all-clear to patients who may be at risk. “They knew this,” Cook told The Los Angeles Times. “I think they should have done something about it, tried to figure out what was going on here.” One former ACC president, Dr. Steven Nissen, called for a suspension of the guidelines, based on the findings. “It’s stunning,” Nissen told The New York Times. “We need a pause to further evaluate this approach before it is implemented on a widespread basis.”
A vigorous defense: The concerns raised by Ridker and Cook led to an emergency meeting at the AHA’s annual Scientific Sessions cardiovascular conference being held in Dallas this week. In a formal statement issued Monday, the two groups defended the guidelines, saying they were based on sound research and were intended merely to “spark a conversation” between patient and medical provider. “These guidelines should enable a discussion between a patient and their healthcare provider about the best way to prevent a heart attack or stroke, based on the patient’s personal health profile and their preferences,” said ACC President John Gordon Harold, M.D. “The risk calculator score is part of that discussion, because it provides specific information to the patient about their personal health. A high score does not automatically mean a patient should be taking a statin drug.” Harold emphasized that the model is significantly better than the previous model.