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It’s ironic to me that on the same day (11-Feb-2010) Bill Clinton underwent surgery to place two stents in one of his coronary arteries Keith Winstein published an article in the Wall Street Journal titled A Simple Health-Care Fix Fizzles Out which explores, among other things, the idea of Comparative Effectiveness, and whether it is or ever will be effective at reducing health care costs.  His article discusses the COURAGE study which concluded (an abstract of the study is available here) that stenting patients with stable coronary artery disease (CAD) did not reduce the risk of: (1) death, (2) myocardial infarction (heart tissue dies because it is starved for blood, similar to a heart attack), or (3) other major cardiovascular events (like a stroke) when used as an addition to optimal medical therapy (drugs); or, in other words, if your medical objective is to manage (1), (2) and (3) above, drugs alone work as well as and maybe better than drugs plus stents (and, by the way, no one gets just stents, they always get the drugs too).

The Wall Street Journal article’s point, however, is the stent procedure, which costs about $15,000, continues despite its apparently dubious medical efficacy for this class of patient.

So, let’s start with some math (I am using Winstein’s numbers here).  The 1 million stent implant procedures done in the US per year cost $15 billion (about $15,000 each).  About 1/3 of those are performed on patients with stable CAD, so adherence to the study’s findings could yield an annual savings of $5 billion.  Compare this to the $200 billion or so it will cost to insure the uninsured in the US and you would be about 2.5% there.  Hey, it’s a start.

Let’s now take the case of Bill Clinton, or anyone else for that matter, who showed up at the doctor with chest pain and got his stents right away.   It has not been reported whether Clinton is a stable CAD patient or not, but his symptom, i.e., his chest pain, is the same symptom demonstrated by stable CAD patients.  According to the output from COURAGE, the protocol for treatment should be drugs for 12 weeks and then a follow-up set of stress tests to determine if the stents are needed.

Winstein goes on to express some perfectly valid reasons why the results of the COURAGE study are largely ignored in practice.  Here’s a short list, containing the usual suspects:

1.  Doctors:  Cardiologists make more money putting in stents.

2.  Payers:  Health insurers don’t monitor stent usage because they pass the cost on to their customers anyway

3.  Patients:  they have no incentive to decline costly care

These reasons point to one of the many problems with the healthcare system, namely the lack of financial accountability, similar to lessons on moral hazard we all learned during last year’s banking crisis.  When we talk about healthcare on this blog, we’re going to come to this moral hazard issue often, it’s imbedded in all that is wrong with the healthcare system.  But I believe the problem with the COURAGE study lies in its inadequate endpoints.  They are primarily clinical and they are economically incomplete and therefore they are not sufficient for a Comparative Effectiveness study.

I would argue that Bill Clinton did not get his stent to avoid a heart attack in the FUTURE.  He got it to reduce his chest pain today.

For Comparative Effectiveness to be a useful economic tool the studies have to measure true economic variables.  One of those variables is patient demand, and I believe if a patient believes his chest pain will diminish from a stent procedure he will see that as the optimum treatment versus drugs alone even if the odds of having a heart attack in the future are not changed.

So, I am a believer in Comparative Effectiveness in theory, but a skeptic that medical trials alone will guide the way.  As a result, I believe innovation requires the deployment of science that brings together clinical realities and market economics to determine the most cost effective approaches to meeting the needs of the patient.  If we couple this with a financial system that includes true consumer financial accountability we will move toward having one of the key components to a value-based purchasing market for healthcare.

Stay tuned…