Nortin Hadler – The Limitations of Comparative Effectiveness Research
Dr. Nortin Hadler at UNC has been a consistent advocate of using evidence to determine what treatments we should use in our health care system. In a new essay at The Health Care Blog, Hadler raises serious questions about just how we should structure the proposals in health care reform for comparative effectiveness research. The essence of Hadler’s argument is simple. Comparing different treatments to see which one works better isn’t as easy as it sounds. Just how you do that comparison and how the evidence you obtain from the research is used can be critical. To illustrate this Hadler points out that there are some treatments where we have plenty of negative evidence regarding their effectiveness, yet we continue to use them every day:
Interventional cardiology for coronary artery disease is the engine of the American “health care” enterprise. Angioplasties, stents of various kinds, and coronary artery bypass grafting (CABG) have attained “entitlement” status. There are thousands of RCTs [randomized controlled trials] comparing one with another, generally leading to much ado about very small differences, usually in surrogate measures such as costliness or patency of the stent. But there are very few RCTs comparing the invasive intervention with non-invasive best medical care of the day: 3 for CABG and 4 for angioplasty with or without stenting. In these large and largely elegant RCTs, the likelihood of death or a heart attack if treated invasively is no different from the likelihood if treated medically. Whether anyone might be spared some degree of chest pain by submitting to an invasive treatment is arguable since the results are neither compelling nor consistent. Yet, interventional cardiology remains the engine of the American “health care” enterprise. It carries on despite the RCTs because its advocates launch such arguments as “We do it differently” or “The RCTs were keenly focused on particular populations of patients and we reserve these interventions for others we deem appropriate.” These arguments walk a fine line between hubris and quackery.
[A]re we using the promise of CER [comparative effectiveness research] to postpone calling a halt to the ineffective and inefficacious engine of American “health care”. The available science is consistent with the argument that interventional cardiology is not contributing to the health of the patient. I would argue that interventional cardiology should be halted until someone can demonstrate substantial efficacy and a meaningful benefit-to-risk ratio in some subset. Then CER can ask whether the benefit demonstrated in the efficacy trial translates to benefit in common practice.
Food for thought as we move forward on health reform. Hadler’s entire essay is worth reading.