Often the answer lies between certainty as to meaningful benefit and certainty as to no benefit. Our values and clinical judgment conspire to inform the decision. That is the 21st century medical treatment act.
In my last book, I take the reader through this exercise for a number of commonly offered and commonly accepted clinical interventions. I define the clinical issue, examine the science for benefit in some detail, and contrast our analysis with that from the Cochrane Collaboration or the like. Surprises abound that have great implications for personal decision making and for policy. In the next book, low back pain provides the object lesson. Let me demonstrate how this works.
Let's examine the example of interventional cardiology. In the United States, well over a million people undergo these procedures each year for various manifestations of coronary artery disease. They are technological advances designed to overcome blocked arteries. They all have technical limitations in that the unblocking or bypassing tends to reverse itself. So there is much invested in the attempt to more permanently overcome the blockage.
There are four stents licensed for this purpose and many in the "pipeline" -- and there are many surgical approaches to bypassing. There are also thousands of trials comparing one technique with another to determine the relative fate of the unblocking.
However, I don't care about the fate of the unblocking. I care about the fate of the patient. Is the patient better off for all this technology?
That central question gets lost in the race for technological achievement. There have been strong reasons for doubt for years. Doubt is now dispelled thanks to four recent randomized controlled trials comparing such interventions with medical care without the interventions.
Three of the trials were American -- OAT, COURAGE and BARI 2D -- and one -- RITA-2 -- was European (these are all acronyms based on the type of heart disease studied). Each recruited thousands of patients and followed them for years. Each recruited a somewhat distinctive population in terms of the manifestations of their coronary artery disease (active angina, after a heart attack, angina and diabetes, etc.), but all recruited patients for whom interventional cardiology was thought to be a reasonable option.
No one, I'll say it again, NO ONE was advantaged by submitting to the intervention. They did not live longer, or have less chest pain, or suffer fewer heart attacks than they would have without the procedure.
Not long ago, I attended "Grand Rounds" at a prominent medical school where the professor and director of the Cardiac Catheterization Laboratory was holding forth on the mechanisms by which newer stents can stay open longer. I asked him how he explains the stent option to a patient with chest pain in view of the results of OAT, COURAGE, BARI 2D and RITA-2.
He, of course, was aware of all these trials. Even though the trials recruited patients with four very typical patterns of disease, he suggested many patients do not quite fit these categories. He was willing to rely on his clinical judgment to infer that a particular patient would be advantaged because he is endowed with a special level of expertise.