Physicians face a consistent great challenge. As we learn more about pathophysiology and pharmacology, our recommendations can change dramatically. We do not really always know what we think we know. As physicians age, we all can give dramatic examples of changed beliefs. Some examples from my career – beta blockers were initially contraindicated for systolic dysfunction – now they are indicated. Who would have thought that we could treat ulcer disease with antibiotics? We once gave estrogen to post-menopausal women to prevent heart disease, now we avoid them to prevent heart disease.
The new cholesterol guidelines have responded to a series of studies and analyses that have made clear that lowering the cholesterol is not the magic goal, rather statins (which clearly lower cholesterol) are “magic” but probably because of their pleiotropic effects.
Pleiotropic effects of a drug are actions other than those for which the agent was specifically developed. These effects may be related or unrelated to the primary mechanism of action of the drug, and they are usually unanticipated. Pleiotropic effects may be undesirable (such as side effects or toxicity), neutral, or, as is especially the case with HMG-CoA reductase inhibitors (statins), beneficial. Pleiotropic effects of statins include improvement of endothelial dysfunction, increased nitric oxide bioavailability, antioxidant properties, inhibition of inflammatory responses, and stabilization of atherosclerotic plaques. These and several other emergent properties could act in concert with the potent low-density lipoprotein cholesterol-lowering effects of statins to exert early as well as lasting cardiovascular protective effects. Understanding the pleiotropic effects of statins is important to optimize their use in treatment and prevention of cardiovascular disease.
This major cholesterol guideline shift should quickly invalidate several major performance measures. We actually predicted this in 2006 – Defining the proper guidelines – the case of cholesterol targets.
So for the past 7 years, we have used performance measurement to encourage lowering cholesterol and stimulating the use of drugs that had no outcome data. 7 years later we have a new guideline.
Should we write a new performance measure? We want to measure something.
What performance measure should we create? I favor using statins for secondary prevention, because the data there are very strong. I oppose measuring statin use for primary prevention, because the data are so much more controversial.
If we are going to measure performance, either to check our systems of care, or to “reward” physicians for doing their job, then we must have very clear measures. We must have measures without controversy. We have had the wrong measures for cholesterol for 7 years, even though we had data to show that only statins make a significant outcome difference.
Our underlying theory was wrong. I have taught for 7 years that only statins matter, because my reading of Rod Hayward’s paper convinced me that goals did not matter, being on a statin mattered. I, and others, taught against the performance measures and guidelines, because we believed the evidence. We were measured wrongly for 7 years, and only now are vindicated.
This story represents an example of just another hazard of performance measurement based on guidelines. We have wasted health care dollars prescribing expensive drugs for 7 years. The guideline just released may fix that problem. I fear that we have so convinced physicians to lower cholesterol that change will not happen as quickly as we want.
I hope that the Choosing Wisely campaign includes adherence to the new primary prevention guideline. Give statins, and only statins.
