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Harvard Biostatistician Attacks New Statin Drug Guidelines

November 19, 2013 By Richard C. Young

After the shocking change in guidelines for statin use issued by the American Heart Association last week, experts like Dr. Paul Ridker and Dr. Nancy Cook are taking issue with the change. Dr. Steven Nissen from the Cleveland Clinic echoes their concerns. Melissa Healy from the L.A. Times explains these experts’ doubts about the guidelines here.

Dr. Paul Ridker and Dr. Nancy Cook, both professors at Harvard, estimate that between 13 million and 16 million of the 33 million middle-aged adults targeted for statin therapy under the new guidelines do not have sufficiently high odds of a heart attack or stroke to warrant a prescription for a statin. Meanwhile, they warned, the risk calculator might give an all-clear signal to other patients for whom statin therapy would be helpful.

Ridker and Cook used the new risk calculator to estimate the 10-year odds of a heart attack or stroke in thousands of people who participated in three landmark medical studies: the Women’s Health Initiative, the Women’s Health Study and the Physicians’ Health Study. When the pair plugged in the real data from study volunteers, the calculator produced estimates that “were almost twice as high as they actually were,” said Cook, a biostatistician at Brigham and Women’s Hospital and a professor of epidemiology at the Harvard School of Public Health.

In an interview Monday, Cook said the scientific advisors who helped develop the guidelines acknowledged in the report’s fine print that the risk assessments were sometimes quite different when tested on groups of people that weren’t used to develop the calculator.

“They knew this,” Cook said. “I think they should have done something about it, tried to figure out what was going on here.”

The full critique from Cook and Ridker, a cardiologist at Brigham and Women’s Hospital who has been an advocate for expanded statin use, will be published Tuesday in the British journal Lancet.

Dr. Steven Nissen, an influential cardiologist at the Cleveland Clinic, said the analysis from Cook and Ridker should prompt the American Heart Assn. and the American College of Cardiology to “take a deep breath and take another look at this” before putting the guidelines into widespread practice.

“If you put the data from hypothetical patients into the calculator, you can get results that are very implausible,” Nissen said. “It’s concerning: we’re not talking about an error or miss of 20 or 30%, but of 75% to 150%.”

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Richard C. Young
Richard C. Young
Richard C. Young is the editor of Young's World Money Forecast, and a contributing editor to both Richardcyoung.com and Youngresearch.com.
Richard C. Young
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