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The SHAPE of medical guideline-setting sausage-making

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It’s not pretty watching sausage being made. Larry Husten of provides a peek at the process – as seen in new and controversial cardiovascular prevention guidelines:

“The Society for Heart Attack Prevention and Eradication (SHAPE) has announced the formation of a new task force “to refine and update” its earlier published guidelines.

The earlier guidelines, when published in a supplement to the American Journal of Cardiology, were not endorsed by the American College of Cardiology, American Heart Association, or the National Heart Lung & Blood Institute, and received a mixed response from the cardiology community. A typical response came from Robert Califf, who told heartwire: “It’s an opinion, it’s not a guideline that’s been vetted through any kind of ecumenical group of people who have any official standing to make clinical-practice guidelines. There’s enough evidence to have an opinion about this; I don’t think there’s enough evidence to have a policy about it. It’s an interesting idea and it could be right. Then again, it may not be right.”

A further complicating factor is the role of SHAPE’s founder and current chairman, Morteza Naghavi, who has numerous financial interests in technologies and devices that stand to benefit from SHAPE policies and the Texas legislation.

On the other hand, the AJC supplement was introduced by a prominent cardiologist, Valentin Fuster, and co-authors of the guidelines included such leading figures as PK Shah, Pam Douglas, Sanjay Kaul, and others. Many cardiologists, though critical of SHAPE and its methods,nevertheless broadly support efforts to identify people at high risk for MI.

The SHAPE press release announcing the new Task Force (see below) takes no note of the controversy and calls the publication “a major breakthrough in preventive cardiology.” The press release also refers to a bill passed last year in Texas that requires reimbursement for heart attack screening, but does not mention that the bill was actively supported and promoted by SHAPE, and that SHAPE was widely criticized for its role in promoting the legislation.”

Husten also includes links to previous Cardiobrief coverage of SHAPE and the full SHAPE news release. From that news release, perhaps the most controversial section was this:

“…the wider use of atherosclerosis tests has improved the affordability of the procedures. In major U.S. cities patients pay approximately $100 to have their coronary artery calcium score (CACS) measured by CT scan or carotid intima-media thickness (CIMT) and carotid plaque measured by ultrasonography. And progress is being made to persuade insurance companies to cover the costs of such preventive screening tests in the interests of public health and prevention. In 2009, Texas Governor Rick Perry signed the nation’s first heart Attack Preventive Screening Bill into law requiring insurance reimbursement for the tests.”

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