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.
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.
The critics of guidelines are Brigham researchers. The initial coverage by Todd Neale at MedPage Today talks about Dr. Ridker’s background conducting clinical trial on one statins and researching the biomarker C-reactive protein as a “marker of subclinical atherosclerosis.”
Less than a week after the American Heart Assn. and the nation’s cardiologists issued guidelines that would greatly expand the number of Americans taking a statin medication, the guidelines have been faulted for overestimating patients’ risk of heart attack or stroke.
Few authors of the new recommendations had even returned to their clinical practices before learning that an influential Harvard cardiologist and his biostatistician collaborator had taken the guidelines to task, arguing they use unreliable data on Americans’ health to calculate which patients would benefit from taking the medication.
Dr. Paul Ridker and Dr. Nancy Cook, both professors at Harvard Medical School, estimate that between 13 and 16 million of the 33 million middle-aged adults targeted by the new guidelines for statin therapy do not have sufficiently high odds of having a heart attack or stroke over the next decade to warrant statins’ use.
Gary Schwitzer offers a round-up within a round-up. His looks at conflicts of interest and link to a very funny cartoon from the Daily Kos, which also ran in the NYTimes week in review.
Some more coverage:
In the summer of 2012, two Brigham and Women’s Hospital researchers were asked to review a draft of a major cholesterol treatment guideline. They sent back a pointed critique, declaring that the authors should abandon a proposed heart-disease risk calculator because it overestimated patients’ chances of getting sick.
So they were shocked when they saw the final guideline, which was issued last week by two leading heart groups. The risk calculator remained an integral part of the document and would be responsible for millions more Americans being put on cholesterol-lowering statin drugs to prevent heart attacks and strokes.
“I’m a strong advocate for statin therapy,” said Brigham cardiologist Dr. Paul Ridker. “I just want to see the right patients get treated.”