Heart and Stroke Study Hit by a Wave of Criticism Michael McElroy for The New York Times Dr. Steven Nissen, a Cleveland Clinic cardiologist, said of a medical committee's guidelines, "There will be a large backlash." It was supposed to be a moment of triumph. An august committee had for the first time relied only on the most rigorous scientific evidence to formulate guidelines to prevent heart attacks and strokes, which kill one out of every three Americans. The group had worked for five years, unpaid, to develop them. Then, at the annual meeting of the American Heart Association, it all went horribly awry. Megan Bearder for The New York Times Dr. Neil J. Stone of Northwestern University led the committee whose guidelines have upset many doctors. Many leading cardiologists now say the credibility of the guidelines, released Nov. 14, is shattered. And the troubled effort to devise them has raised broader questions about what kind of evidence should be used to direct medical practice, how changes should be introduced and even which guidelines to believe. "This was a catastrophic misunderstanding of how you go about this sort of huge change in public policy," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who is a past president of the American College of Cardiology. There will be a large backlash. What went wrong? Some critics say the drafting committee mistakenly relied only on randomized controlled clinical trials, the gold standard of medical evidence, but ignored other strong data that would have led to different conclusions. The group's efforts were severely underfunded. And it announced fundamental changes in medical practices without allowing a public debate before its guidelines were completed. "A lot of people expect they can come up with guidelines as a pure scientific discourse and present them to the public," said Dr. J. Sanford Schwartz. a committee member and a professor at the University of Pennsylvania. That's what we did here, but the world has changed. When the new guidelines were released, many doctors were shocked that they were suddenly being told to stop their decades-long practice of monitoring levels of LDL cholesterol, the kind that increases the risk of heart attacks and strokes, after patients begin taking statin medicines. Others were stunned when a pair of Harvard medical professors offered evidence within days of the guidelines" release that its new online risk calculator greatly overestimated a person's chance of having a heart attack or stroke. The committee writing the guidelines made a critical, early decision to consider only evidence from clinical trials, a marked departure from how previous guidelines were made. Some independent experts provided with an advance draft of the guidelines, including Dr. Roger S. Blumenthal of Johns Hopkins and Dr. Antonio M. Gotto Jr., a former president of the heart association, objected. They said a wealth of genetic and populations data indicated that lower cholesterol levels are better, especially for high-risk patients. The same critique would loom large after the guidelines were released. Committee members also said they struggled with inadequate financial support. They originally formulated 18 important questions they would seek to answer. But it was soon apparent that they had overreached and did not have nearly enough money from the National Institutes of Health for such an ambitious effort. "It definitely was a funding issue," said Dr. Daniel J. Rader, a lipid specialist at the University of Pennsylvania who was a committee member for much of the time. And the money dwindled over time after the National Institutes of Health underwent budget cuts. Every time the agency got hit, so did support for the committee drafting the guidelines, said Dr. Elizabeth G. Nabel, who was director of the heart institute for much of the time. "This is one of the untold consequences of budget reductions," she said. Eventually, the committee whittled the 18 questions to just three: Should doctors and patients aim for specific numerical target levels of LDL cholesterol? Should doctors use drugs other than statins to drive LDL levels down? And should there be target levels for LDL plus other forms of harmful cholesterol linked to cardiovascular risk? They concluded that there was no evidence for targets or for using drugs in addition to statins to lower cholesterol. The National Heart, Lung, and Blood Institute contracted with two companies to exhaustively review the scientific literature - thousands of papers submitted by committee members on those three questions. Meanwhile, the committee met by teleconference most Wednesdays.