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How Clinical Guidelines Can Fail Both Doctors and Patients

Any confusion over the recent news of cholesterol guidelines in the U.S. is perfectly understandable. On the one hand, the guidelines suggest that nearly half the population should use statins to stave off heart attacks and strokes. On the other, use of the drugs is not with potential side effects and, to many, will offer no substantive benefits. The controversy highlights a problem mired in an outdated way of thinking about health care and the doctor-patient relationship.

Guidelines came about after generations of physicians wanted to bring something more than “opinion and experience” to the patient’s bedside. In the late 1960s legislation for the U.S. Food and Drug Administration was amended to call for a demonstration of efficacy and an assessment of benefits and risk as prerequisite to the licensing of any pharmaceutical. Modern clinical science resulted, first slowly and now with an avalanche of clinical trials, each pouring forth outcome data galore.

The Burden of Clinical Data

Clinicians are expected to stay current with this wealth of information. The modern medical curriculum instructs all budding physicians on how to evaluate the quality and the clinical relevance of all such contributions to the body of clinical science. Because some (or perhaps many) find this exercise overwhelming, there are organizations—many academic and some without any discernible relationships with purveyors that could pose a conflict of interest—that attempt to bundle the information in a fashion that might be relevant to particular physicians or physicians in particular specialties. Some of this bundling is quite systematic, some quite helter-skelter.

Occasionally there is a contribution to the literature that offers an unequivocal advantage for a particular patient group. More often, the bundlers are faced with a heterogeneous literature that often demonstrates little, if any, efficacy. Faced with these circumstances, biostatistics has offered up many a method to impute more value to the literature than is apparent at first blush. The result is that all this bundling adds to an enormous and ever-expanding secondary literature.

What is the clinician to do?

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The Cholesterol Gulag

Last week, we were amongst the very first opinion leaders to speak out against the new cholesterol guidelines from the American Heart Association (AHA) and the American College of Cardiology (ACC).

Our error was not going far enough.

Monday’s New York Times carried a devastating portrait of the development of the guidelines, leaving readers with the unmistakable impression that this absurd attempt to make people into patients was not just poor policy it was a hubristic, avoidable policy folly, sort of like the bridge to nowhere and federal housing policy pre-2008.

Trust is an interesting thing; once broken it almost resists reconstruction.  Public trust in the AHA and ACC is crumbling as we write and deservedly so, as what should have been clear becomes more confusing and conflicted by the minute.

Instead of giving generally healthy middle aged American adults (like the three of us) the safe haven of a cardiovascular disease (CVD) prevention framework that is understandable, sensible and actionable, we got a cholesterol gulag.  Only here in the land of the free, it’s not a government gulag imprisoning the political opposition.

No, in a phenomenon unique to the US, it’s a health gulag intended to take people who need advice, support, and guidance and give them a pill, which is the first step in an intentional ensnarement in the medical care system.  It’s the Hospital California…on steroids, and you can’t even checkout because that would be against this addled medical advice.

To clarify: we have zero objection to providing statins, especially low-cost generic ones, to people under age 75 with current CVD, diabetes, or extremely high cholesterol levels.  The drugs may very well save their lives.

Our beef is with the cockamamie reduction in the ‘risk-to-treat’ threshold from 10% risk of heart attack or stroke in the next 10 years to 7.5% for people with none of the above noted problems.

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