Friday, November 6, 2009

Another Slap at Physicians: NY Times and CCE

In a recent piece in the NY Times by Leonhardt the author is "amazed" that a physician admits that in the history of medicine that physicians have done more harm than good. I am amazed, truly amazed. Well anyone who has the slightest knowledge of history would know about the bleedings and the like. Why Just look at George III and his blood disorder, it may very well have been the cause of the Revolution. But I wander.

Let me focus on Leonhardt and his "revelations regarding Comparative Clinical Effectiveness (CCE). In my opinion this article appears to be a piece crafted by those who want Government control of medical practices, as ultimately a way to reduce costs. Let me build my argument and perhaps you too will see it that way.

Leonhardt claims that medicine has never adopted the scientific method. I suspect he has never read a New England Journal of Medicine (NEJM) article. Each week there are at least a half a dozen articles clinically comparing one method to another, using well accepted statistical methods, and always seeking to improve the practice of medicine. Although I have never practiced Medicine, for some reason, each year for decades, I dutifully continue to take my two NEJM, Massachusetts Medical Society, CME tests totaling 100 CME points and entailing 100 papers detailing these comparative clinical studies. Thus I speak from experience. All practicing physicians as a requirement to maintain their licenses must do the same. Thus despite what Leonhardt reports physicians are continually training and an essential part is learning what is new and what is best. The conclusions are always changing as new information becomes available.

Now back to the article. The author states:

" But there is one important way in which medicine never quite adopted the scientific method. The explosion of medical research over the last century has produced a dizzying number of treatments for different ailments. For someone with heart disease, there is bypass surgery, stenting or simply drugs and behavior changes. For a man with early-stage prostate cancer, there is surgery, radiation, proton-beam therapy or so-called watchful waiting. To enter mainstream use, any such treatment typically needs to clear a high bar. It will be subject to randomized trials, statistical-significance tests, the peer-review process of academic journals and the scrutiny of government regulators. Yet once a treatment enters the mainstream — once we know whether it works in certain situations — science is largely left behind. The next questions — when to use it and on which patients — become matters of judgment, not measurement. The decision is, once again, left to a doctor’s informed intuition."

Let me address the two diseases he mentions above. I suspect one must have to know something about this to comment and Leonhardt seems in my opinion totally ignorant and destined to present the position of HR 3962 and the Administration, even if it falsely presents information.

First, take the blocked artery problem. Just go to Harrison's Sixth addition, yes I have it on my bookcase, across from Harrison's 17th. In the 6th we are told how to handle a blocked artery, not really very helpful, but cheap. In the 17th we are told how to deal with it and there are many options, some better than others, and the details and comparisons are there in their full glory. It is one of the on-the-one-hand and then-on-the-other-hand types of arguments. It is patient specific in many cases. One can treat it medically at first, then consider a stent or even a graft. It depends on age, the health of the patient and the like. There is no simple nomograph to ascertain an answer.

Second, and my favorite, prostate cancer. The fact is that we just do not know what prostate cancers will kill men. This most likely is a complex epigenetic problem wherein there are genes which are activated and they then in turn activate other genes and so on. A simple Gleason score may help but is in no way diagnostic. We can determine by biopsy who has prostate cancer and its extent. We cannot tell which ones will spread aggressively. I have seen ones go from a PSA of 4 and no detection to a PSA of 50 and Gleason 8 in a year and then two years later a met to the spine and death. Then there is a PSA of 23, a Gleason of 7 and it just goes no where for decades. Go figure, the science is just not there. To deliver an algorithm of watchful waiting for all would be a death sentence. As Osler said, listen to and look at the patient.

Then Leonhardt goes on to Type II Diabetes. He states:

"At one primary-care meeting I attended, Dr. Scott Lindley said he had heard complaints from
doctors who thought the committee made a mistake by setting the goal for hemoglobin A1c levels — a common measure of blood sugar in diabetes patients — at 8. If an obese person came in at 13 and the medical team reduced the level to 9, wasn’t that a success? An 8 might be too ambitious a benchmark, Lindley said. “Some literature shows 9 is better,” he noted.

In response, Dr. Michael Visick, another committee member, pointed out that nobody was being punished for having patients with hemoglobin levels above 8. Doctors were simply asked to take a second look at those patients. And the only reason the committee set a benchmark was that data had shown the percentage of patients with a level above 8 was rising, Visick said. That was a sign that Intermountain’s diabetes care might be slipping. Lindley seemed to accept the explanation. Still, he added with a tone of mild sarcasm that he was sure his colleagues would “just go away happy” when he conveyed the explanation to them."

Here I would disagree with the physicians. An HbA1c of 8 is too high. First a 13 in an obese person is in my opinion self inflicted. Get the BMI down to 22.5 or lower and the HbA1c drops below 5! They are managing the patients and not the disease. There is never a physician saying to the patient that they must lose weight or there will be consequences. It often is just more insulin. The Diabetes care is getting the obese patients to lose weight, NOT manage HbA1c! Here I would disagree with the Intermountain team, they are being politically correct and not telling the obese person what the cause of their disease is. It was no problem to tell them to stop smoking but somehow there is a problem of telling them about weight.

Leonhardt then gives a countervailing view:

" He (Groopman, Harvard doctor and New Yorker writer, published a book called “How Doctors Think.”) argues that evidence-based medicine is useful in only a limited number of run-of-the-mill situations, like distinguishing between strep throat and a simple sore throat. “Human beings are not uniform in their biology,” wrote Groopman and Pamela Hartzband, a Harvard endocrinologist (and Groopman’s wife), in a Wall Street Journal op-ed article criticizing the Obama administration’s plans to tie Medicare payments to so-called quality metrics. “A disease with many effects on multiple organs, like diabetes, acts differently in different people.” Groopman and Hartzband mentioned a handful of studies in which protocols had led to outcomes that were no better, or even worse, than what doctors had previously been doing. A couple of the studies dealt with the regulation of blood sugar in diabetics, the same issue that came up in the primary-care meeting I attended at Intermountain."

Groopman is spot on. No one patient is the same as any other. Strange thing those genes. Yes Diabetes acts differently on different people as does prostate cancer as does a blocked artery. Each patient is somewhat different. Thus the task of the physician is to use what he or she may have at their command and then do their best to "care" for the patient. Having a list of what to do and having the orders to follow the list would take us back to the days when the number of deaths caused by physicians would rise again. Disease causes enough damage, Government should not become the number 1 cause of death in the US. Data is essential, understanding what works and why, and how well is essential. I do not think Groopman denies any of that. What Groopman is saying is that one must always look at and towards the patient, each is different in different ways. It is the difference between the 4th year student who has memorized everything and can tell the Chief Resident on Rounds what the most likely causes for a disease is in descending order and the other 4th year who has actually spoken with the patient to find out what truly is their problem. Just knowing the algorithm will not work.

On to my least favorite example, bundling. Leonhardt states:

"Several pilot programs with similar aims have made it into some of the health-reform bills considered by Congress. One is a bundling program, in which Medicare would pay hospitals a set fee for certain operations or chronic illnesses, rather than paying piecemeal for every aspect of the treatment. Hospitals would then have an incentive to avoid complications and readmissions, because they would no longer be automatically reimbursed for them. The hospitals that did the best job of keeping their patients healthy would end up helping their bottom lines. The details are still being fleshed out, but Medicare or private hospital groups would most likely monitor outcomes to make sure the incentives didn’t lead hospitals to skimp on care or turn away the sickest patients."

Bundling is the principle that a center, in most cases the Hospital, takes primary care of you for say your Diabetes, and they get reimbursed for your care and they in turn pay out some fraction to your Internist, Cardiologist, Nephrologist, Neurologist, your Ophthalmologist and the like. Your relationship as a patient is broken with the direct provider and then linked to the Hospital. Hospitals love this the physicians do not It also make no sense clinically. Remember the problem goes away if you just stop eating the Milky Ways and lose weight, in almost all cases. Yet this bundling approach will institutionalize the problem, it will make it to the hospital's benefit to keep the patient sick. It also will institutionalize old methods and techniques and will actually counter the CCE methods.

Thus what good is this article of Leonhardt? It seems in my opinion to be another NY Time SOP to the current Administration in support of the new HR 3962. It clearly is neither balanced nor reflective of reality.