Podcast:

DrRich does not like to pick on the New York Times.

No, really. DrRich does not like to pick on the New York Times, because he receives two paychecks each month from the New York Times*. This fact (which has been disclosed on this blog since its inception in 2007) constitutes a clear conflict of interest, at least when it comes to writing blog posts which might criticize or satirize or mock articles that appear in that venerable publication, from which he receives a not insubstantial proportion of his livelihood.

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*DrRich holds two positions at About.com, which is a New York Times Company. He has manged About.com’s Heart Health Center for 11 years, and also serves on About.com’s Medical Review Board.
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Yet, regular readers will know that the New York Times has served as a regular source of material for DrRich here at the CRB, and little of what he has written in response to that material has been supportive of it. Indeed, the opposite is true.

DrRich considers it his duty to respond to the New York Times whenever it publishes an article that advances the covert rationing of American healthcare, which (through no fault of his), it does frequently. The New York Times serves as a chief voice of Progressive America, and the Progressive takeover of the healthcare system has become, since this blog was first begun, the chief driver of covert rationing. So, conflicts of interest to the contrary notwithstanding, DrRich submits to his readers that he has acted responsibly and honorably despite his unfortunate financial conflicts.

But still, he does not like to pick on the New York Times.

It is unfortunate for DrRich, then, that for the second time this week he is compelled to do so. And this time, as it happens, the subject matter has to do with conflicts of interest (a subject about which, as he has just disclosed once again, DrRich knows something).

Today, the Times writes that experts are beginning to worry that the GOD Panels (Government Operatives Deliberating) now working to devise the clinical guidelines under which American doctors will be strictly compelled, under penalty of the law, to decide which patients will get what, when and how, are tainted by members who have had ties to (gasp!) industry.

When the GOD Panels were first set up, not very long ago, it was still considered acceptable for some members to have industry ties as long as they fully disclosed those ties, and recused themselves from voting on matters specifically related to their industry work. Having at least some members with industry ties was deemed essentially unavoidable, because it was thought that deep subject-matter expertise would be desirable on these panels. Since most clinical research in America is paid for by industry, it is difficult to have deep expertise without having had at least some contact with industry.

But as the Times indicates, modern medical ethics has now advanced well past this kind of primitive thinking. Nobody with any industry ties has any business being on a panel with such overwhelming authority over the practice of American medicine.

David J. Rothman, president of the Institute on Medicine as a Profession, tells the Times, “Consciously or not, they may well be making decisions that fit their funders, their payers and not the patient’s best interests. If you want the public to really believe in the guidelines, why not have a committee that is conflict-free?”

And the ubiquitous Dr. Steven Nissen of the Cleveland Clinic (a person DrRich numbers among those individuals who, by their public words and deeds, he speculates may be auditioning for the really important GOD Panels) says, “Recusing, disclosing — the reason it doesn’t work is the process involves give-and-take. Even if you don’t make a formal vote, you can still have a huge influence over what happens in the process.”

And so, while the Times does not come out and say so, it seems as if a purge of the GOD panelists may be already afoot. If not an actual purge, then at least the “conflicted” panel members are being sent a clear message, well before they take any final action. And at the very least, Ms. Sebelius is being given the cover she needs to select the people she really wants for the truly important GOD Panels which are being constructed for Obamacare.

All of this is pretty clear, and DrRich has great confidence that his readers can figure it out for themselves.

What DrRich really hopes to accomplish here is to note for posterity the great paradigm shift that has occurred in just the last two or three years, regarding the appropriate relationship between physicians and industry.

Until very recently, the American public, doctors, industry, and medical ethicists thought about that relationship in a certain way, which DrRich will call Theory A:

Theory A:

-  Medical progress is Good, and benefits mankind.
-  Industry is responsible for a high proportion of medical progress.
-  Industry-driven progress requires the active participation of physicians.
-  Therefore, a well-managed cooperation between industry and physicians is beneficial to mankind, and ought to be encouraged.

If you subscribe to Theory A you believe that, because well-managed physician-industry relationships benefit mankind, these relationships are good. So, fundamentally, it’s the management of these relationships which is at issue. These beneficial relationships produce unavoidable conflicts of interest, which we must manage by strictly limiting their extent, and fully disclosing the ones that are left.

So traditionally, the debate about conflicts of interest have been about where to draw the necessary limits.

What today’s New York Times article points out is that Theory A is no longer operative. The new thinking begins with the proposition that no amount of conflict of interest is acceptable, and ALL physician-industry ties should be prohibited. One of the most prominent advocates of this new thinking is Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of conflicts of interest is not to have them at all.” For these voices, Theory A simply does not apply. Rather, they subscribe to Theory B:

Theory B:

-    The greed of medical industry creates excessive costs, and produces far more harm to society than good.
-    Physician-industry alliances strengthen industry, and increase the harm.
-    Therefore, crippling these unholy alliances is critical to the interests of society.

Underlying Theory B, of course, is the largely unspoken and unacknowledged, but nonetheless fully-embraced, proposition that medical progress is not Good after all, but is the very thing that is driving up our healthcare costs, and so it must be stifled.

A corollary of Theory B is that not only is the Central Authority the only entity which is strong enough to cripple these unholy alliances between physicians and industry, but it is the duty of the Central Authority to do so.

Proponents of Theory B, noting, not incorrectly, that medical industry is chiefly concerned with profits rather than the public good, conclude (in a manner compatible with Progressive if not classical logic) that therefore industry will always behave in ways that are counter to the interests of society.  While many proponents of Theory B will agree that industry provides at least some benefits, they are convinced that these benefits are far outweighed by the harm they produce to the collective. Therefore, Theory B proposes to stifle, if not cripple, medical industry. And a very useful strategy for achieving this goal is to de-legitimize any practical relationships whatsoever between medical industry and physicians.

Proponents of Theory B rarely say what their real goal is. To come out and say that their goal is to cripple the companies responsible for producing medical progress would not be expedient. So most of them still give lip service to Theory A. One must discern their real motives from their behavior.

Much of that behavior, in practical terms, has to do with controlling the flow of information. Let industry develop whatever it wants (perhaps), but don’t let profit-drunk industry – or its greedy physician spokespersons – instruct doctors and patients on who ought to use industry’s products, or when and how. That kind of information can only be managed by unbiased sources.

This is the very thinking that produces the impetus for GOD Panels in the first place. Only experts who are free of industry ties and who answer only to our beneficent, unbiased, completely objective government can say which products of industry are good and bad, and can manage the flow of information about them. Information coming from anywhere else is to be regarded as being charged with bias and greed, and should be ignored, or even suppressed by whatever means are necessary.

To any reader who believes that our government is or can ever be an unbiased and honest broker, or that government officials (or GOD panelists) can cancel their own human natures when they put on a government name tag, DrRich can only wish upon you the grace of God (the old fashioned one). You’ll be needing it. To the rest of us, it is obvious that the government is desperately biased when it comes to medical progress in general, and in particular when it comes to establishing “guidelines” for the use of expensive drugs and medical devices.

For Theory B to have become the operative paradigm in America, as the New York Times today suggests it has, will assure the Central Authority that it is free to seed its GOD Panels only with members whose bias runs in their direction.

But under Theory B there is no government bias. There is only industry bias. And when we purge the GOD Panels of all industry bias, by definition we will have created perfect objectivity.

And this is why DrRich feels so comfortable continuing to write this blog despite his obvious financial conflict of interest in favor of the Times. For a conflict of interest in the direction of the Progressive agenda is no conflict at all.

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Q: What’s the difference between a public health expert and an ax murderer?

A: Actually, there are two differences. The public health expert usually means well. And the public health expert has only metaphorical blood on his hands.

In a prior post DrRich related how public health experts, displaying every ounce of the overblown self-confidence traditionally enjoyed by the expert class operating within our Progressive institutions, have wreaked all manner of harm upon our society with their premature promotion of Low-Fat Diets, an action which, DrRich argued, is at least partly responsible for triggering our current epidemic of obesity (and therefore, according to some respected experts, global warming).

As if causing the rotundity of the American populace (and again, with less certainty, the impending destruction of our planet) was not enough, it is now beginning to appear as if another major public health initiative, an initiative with which we have all been pummeled mercilessly for over two decades, also may be based upon a faulty premise.

DrRich speaks, of course, of the long crusade which the experts have preached, and which we among the faithful have doggedly waged, against cholesterol. While nobody is talking about it, it is beginning to appear (to DrRich, at least) as if the fundamental hypothesis underlying our long war on cholesterol is far less solid than we have been assured.

DrRich is moved to describe his uneasiness with the cholesterol hypothesis at this time because, last week, yet another nail was driven into its coffin.

The Cholesterol Hypothesis

Our war on cholesterol is based on the cholesterol hypothesis, which states that an elevated cholesterol blood level is a major cause of atherosclerosis, and therefore of heart attacks, strokes and peripheral artery disease. The hypothesis goes on to describe two major species of blood cholesterol – LDL cholesterol, or “bad” cholesterol, which increases cardiovascular risk; and HDL cholesterol, or “good” cholesterol, which reduces cardiovascular risk.

According to the cholesterol hypothesis, the LDL cholesterol molecules deliver excess cholesterol to the lining of the arteries, where it gradually accumulates, leading to the buildup of the plaques that obstruct blood flow. HDL cholesterol represents cholesterol that has been removed from those plaques (so the higher the HDL level, the more cholesterol is being removed)

Therefore, it behooves every American to work assiduously to reduce our LDL cholesterol levels and increase our HDL cholesterol levels.

This, of course, has become more than merely a suggestion or recommendation. Under our new incipient universal healthcare paradigm, in which your suboptimal health habits directly affect the healthcare services which will be available to me, your failure to control your cholesterol and your subsequent utilization of precious healthcare resources amounts to attempted murder, and is therefore a grave crime against humanity.

The cholesterol hypothesis is based upon two observations gleaned from clinical research. First, that high LDL cholesterol levels are significantly associated with the risk of heart attack, &c. (and that high HDL cholesterol levels are associated with reduced risk); and second, that lowering LDL cholesterol levels (or increasing HDL cholesterol levels) with drug therapy lowers that risk.

It was this second observation that “clinched” the cholesterol hypothesis for the public health experts (and most doctors).  And this second observation is based virtually entirely on the statin drugs. Until the statin drugs were first developed – drugs that powerfully and reliably reduce cholesterol levels – it had never been convincingly demonstrated that lowering cholesterol levels actually did any good.

And so, according to the cholesterol hypothesis, every American is obligated to work to maintain “healthy” cholesterol levels. In general, we are urged to begin with diet and exercise, and if that does not work (and depending on the level of our cardiovascular risk) we are likely expected to begin on drug therapy.

But DrRich suggests (reluctantly, since by doing so he undoubtedly invites even more personal attacks against his intellect, honesty, personal appearance, parentage, &c.), that the cholesterol hypothesis may not be correct.

Evidence Against the Cholesterol Hypothesis

1) Despite several clinical trials showing that the kinds of lifestyle modifications which are officially  recommended for the reduction of cholesterol can in fact reduce LDL cholesterol levels, it has not been shown that such lifestyle-induced cholesterol reductions lead to improved clinical outcomes.

2) Early (pre-statin) cholesterol-lowering trials (using clofibrate, cholestyramine, and gemfibrozil) were unable to demonstrate that an improvement in cardiovascular mortality accompanies a reduction in cholesterol levels, and indeed, each of these studies showed an unexpected increase in non-cardiovascular mortality with the cholesterol-lowering drugs.

3) More recently, studies showed that adding the powerful non-statin cholesterol-lowering drug ezetimibe  to a statin drug not only failed to improve outcomes, but also (unexpectedly) may have led to more plaque growth than was seen with the statin alone. (Ezetimibe is marketed as Vytorin in those god-awful commercials comparing your Aunt Helen to a strawberry cheesecake.)

4) Just last week, the NIH prematurely halted a high-profile study (the AIM-HIGH trial) comparing statin to statin + niacin in patients with cardiovascular disease and low HDL levels. (This study was designed to show that increasing HDL levels with niacin would improve outcomes.)  The study was stopped 18 months ahead of schedule not only because it was determined to be extremely unlikely that the increase in HDL produced by niacin would improve outcomes, but also because of an unexpected increase in strokes among the patients receiving niacin.

5) Numerous trials using statin drugs have demonstrated that these drugs can reduce cardiovascular events and improve cardiovascular mortality – without an increase in non-cardiovascular mortality – in patients who have known heart disease or who are at increased risk for heart disease. However, the mechanism by which statins provide these benefits may have little or nothing to do with their cholesterol-lowering effects. (Statins have several mechanisms of action under which they can improve cardiovascular outcomes, including stabilizing plaques, improving endothelial function, reducing intravascular blood clotting, and reducing inflammation. Each of these mechanisms can directly and immediately reduce the risk of heart attack and stroke – more directly and immediately, one must concede, than by merely reducing cholesterol levels.) So, for instance, when statins are administered during acute coronary syndromes, their benefits are seen immediately – an effect not explained by the cholesterol hypothesis.  Further, the JUPITER trial showed convincingly that statins can improve outcomes even in patients with “normal” cholesterol levels, which is also not explained by the cholesterol hypothesis.

In summary, lowering cholesterol by any method other than statins has not been shown to significantly improve outcomes.  And evidence indicates that the chief benefit of statins may be imparted by the drugs’ non-cholesterol-lowering mechanisms.

These observations suggest an alternate hypothesis.

The Bear Shit Hypothesis

If you are walking in the woods and you see bear droppings, your chances of being eaten by a bear are much higher than if there were no bear droppings. But if you take out your (legally registered) firearm and shoot the bear droppings, you have not improved your risk at all.

DrRich maintains that the totality of the data regarding cholesterol, as it exists today, is entirely consistent with the bear droppings hypothesis.  That is, elevated cholesterol levels may (and certainly do) indicate a higher risk of cardiovascular disease, but may not themselves be a causative factor.

Indeed, the bear shit hypothesis can explain the facts as we know them much better than the traditional cholesterol hypothesis. The bear droppings hypothesis can explain why treating cholesterol with any of several methods (aside from statins) fails to improve risk.  (While cholesterol is associated with atherosclerosis, it may not be a critical cause of atherosclerosis.)  Since discharging one’s firearm at bear droppings might awaken a sleeping bear, the bear droppings theory is also consistent with the fact that reducing cholesterol with virtually any drug save one of the statins may actually worsen outcomes (by creating sundry “unexpected” medical problems of one variety or another).

That is, unless you are using statins (which have several important therapeutic effects unrelated to reducing cholesterol, and which in high risk patients far outweigh – statistically speaking – any side effects these drugs have), treating cholesterol levels with drugs may turn out to be a bad idea.

The Bear Shit Hypothesis, being merely an hypothesis, may not be correct, either. But it seems to fit the existing clinical evidence at least as well as – and DrRich suggests, better than – the cholesterol hypothesis. And at least DrRich admits his hypothesis may not hold up at the end of the day, and does not insist that all his fellow citizens drop what they are doing and rearrange their entire lives to comport with its implications.

Where Does This Leave Public Health Experts?

For over 20 years, the cholesterol hypothesis has been presented to the public, with all the evangelical fervor employed by the global warming experts, as settled science.  There is clearly some muttering going on these days amongst the experts – in their private conclaves – about certain “anomalies” that have appeared in the clinical database over the past decade or so, anomalies which have muddied the nice, clear cholesterol hypothesis they have so forcefully promulgated for so many years. They are desperately trying to explain away these anomalies by subdividing LDL and HDL cholesterol into more and more complex “subspecies” that have “counter-intuitive” behaviors. (This latter effort has the benefit of being so mind-numbingly complex that nobody can follow it – which means that it is difficult to assert with any authority that it’s all folderal.)

In the meantime, because statins are effective at reducing cardiovascular mortality and morbidity, and because statins also (quite possibly as an unrelated side-effect) reduce cholesterol levels, the experts can continue to trumpet their cholesterol hypothesis to an unsuspecting public, with the caveat that statins ought to be the drug therapy which one should try first. They have not yet reached the point where they are willing to say that if statins are not tolerated, one should probably not attempt to reduce cholesterol levels with any of the non-statin drugs (i.e., with drugs that merely reduce cholesterol).

And so, for the second time we see that a massive public health campaign that has been whipped up by the expert class is likely to turn out to be a wrong-headed “experiment,” one which so far has been conducted on the entire population for more than two decades.  This time (and in distinction to the low-fat diet “experiment”) it appears that little widespread harm has been done. But this result is fortuitous, and is most likely related to the fact that statin drugs turn out to help prevent the rupture of atherosclerotic plaques by means apparently unrelated to their cholesterol-lowering abilities.

What will the experts do if the cholesterol hypothesis finally is proved to be mistaken? It is easy to predict. They will stick tenaciously to their cholesterol hypothesis until the last possible minute, then if and when they at last find it to be utterly unsupportable, they will simply move on to the next hypothesis as if the old one never existed.

For one thing we know with certainty about the expert class is that they are never chastened. Their low-fat diet dogma simply and smoothly elides into a Mediterranean diet mantra (a diet, as it happens, with plenty of fats). Their demands that “safe” trans fats be substituted for saturated fats in processed foods simply transforms, 10 years later,  into indignant demands that the trans fats be removed when it is discovered they are worse than saturated fats. The phrase “global warming” is simply dropped in favor of “climate change” when it is discovered that the planet actually has been cooling since the 1990s.  In no case is there an acknowledgement that their prior expert pronouncements have been both arbitrary and wrong, and much less is there ever an apology. Being experts, and thus by definition correct, they never, ever have anything to apologize for. They simply abandon the old dogma as needed, and seamlessly adopt the new one.

For when you’re an expert within our multiplicity of institutions for public improvement, history will always have begun 10 minutes ago.

Podcast:

While DrRich is a conservative American, and has made plain the difficulties he has with the Progressive program in general and with Progressive healthcare reform in particular, at times he is forced to admit that, on occasion, the Progressive way of looking at the world has certain merits. And as DrRich contemplates a question that has been bothering him lately, a question that no doubt plagues many American physicians who (unlike DrRich) are still toiling away in the trenches, he finds that this is one such occasion.

That question is: Just who are the people writing all those clinical guidelines – the  “guidelines” physicians are now expected to follow in every particular in every case, on pain of massive fines, loss of career, and/or incarceration?

DrRich is quick to say that the act of creating clinical guidelines is not inherently evil, and indeed, back in the day when guidelines were merely guidelines (instead of edicts or directives that must be obeyed to the last letter), creating clinical guidelines was a rather noble thing to do.

But today, we have physicians clamoring to become GOD panelists (Government Operatives Deliberating). These aristocrats of medicine will render the rules by which their more inferior fellow physicians, the ones who have actual contact with patients, will live or die. Clearly positions of such authority will be very desirable, and so, as one might predict, they are being vigorously pursued. And we are seeing candidates audition for these panels with efforts ranging from amateurish to ruthless. It puts one in mind of the early-season contestants on “American Idol.”

We see them vociferously extolling, in every public venue they can find, the idea of “fly by wire” medicine, whereby every decision physicians make will be determined not at the bedside but by the best and the brightest experts, acting at a distance. The experts will distribute rules of action based on only the best scientific evidence (“best” being determined by those selfsame experts). The directives they hand down will be models of actionable simplicity,spelled out so unambiguously that even doctors born, raised, and trained in the Midwest or the South will be able to follow them.  (And if the doctors refuse to cooperate sufficiently, non-physician medical professionals will be able to do the job.) We see them writing scientific papers that spin the evidence in such a way as to generate conclusions which will be soothing to the Central Authority. We see them editing medical journals in order to make certain that the correct conclusions are published, and the incorrect ones are not. We see them taking control of professional organizations, and using their positions to promulgate changes in medical ethics that advance the Borg-ification of medicine, and to formally endorse Obamacare on behalf of American physicians who, for the most part, were against doing so.

These people have gained great prominence within our healthcare system, and practicing physicians will be dealing with them and the consequences of their actions for many years to come. While the natural impulse of us typical American doctors may be to simply marvel at the wonder of it all, shake our heads resignedly, and go about our increasingly distressing business, it may behoove us to take a closer look at these individuals, to attempt to understand them a little better. After all, their activities in the near future promise to greatly impact our lives, our fortunes, and our sacred honor.

So – who are they, anyway?

This, dear reader, is where the Progressive mode of thought comes in handy. DrRich refers, of course, to the Progressive doctrine of Diversity.

Diversity, for those who pretend not to know, is perhaps the chief mechanism by which Progressives attempt to control the behavior of the population.

Recall that the Progressive program is to create the perfect society. The Progressive elite know just how to do this, of course, but individuals within every population throughout human history have insisted upon acting in their own self-interest, which is counterproductive to the collective goal. In past efforts to perfect human societies, such individual recalcitrance has been dealt with by means of concentration camps and pogroms and the like. “Diversity,” we all should admit, is a much kinder and gentler approach to curing the problem of individualism.

Specifically, the doctrine of Diversity defines the range of permissible behaviors and thoughts for a given group of people within a society. The numerous celebrations of Diversity we see all around us invariably turn out to be strategies to reinforce those allowable ranges of thought and behavior. In this way, members of a particular group who begin behaving and thinking outside the allowable range can be quickly identified and dealt with, either through correction (which brings them back into the group), or through vilification (which marginalizes them). It is easy to become confused about this, since classically “diversity” means something other than “conformity.”  (As a general rule, if you want to know what Progressives are really up to, listen to what they say and then look to see if their deeds are actually working toward the opposite thing.  DrRich thinks that much of the time you will find that they are.)

In any case, while in general DrRich does not approve of Diversity as it is being practiced today, he finds that the concept might be useful in attempting to answer the question at hand.

Specifically, DrRich refers to his theory that physicians (like any humans) tend to end up in careers that best suit their underlying personalities and proclivities, and so physicians in a given specialty will tend to think and behave like other physicians within that specialty, and unlike physicians in other specialties. If this theory has any merit (and let us call it the Diversity Theory of Physicians), it will allow us to make some generalizations about the characteristics of individuals who have chosen specific kinds of medical careers. DrRich stresses that he is aiming to make generalizations only, and while those generalizations might help enlighten us to a modest degree regarding, say, what sort of physician will end up on the GOD panels, they can tell us nothing about particular individuals.

With that annoying disclaimer out of the way, let us examine some ways in which the DTP reveals Truth. An obvious example is the specialty of psychiatry, which tends to attract doctors who are, perhaps subliminally, concerned that they are just a little crazy themselves. As it happens, it often turns out they are correct. In DrRich’s experience, and in the experience of just about anyone who has encountered more than a handful of shrinks, these fine physicians, on average, display an astonishing degree of off-the-wall psychopathology. (Not that there’s anything wrong with that.)

Emergency room doctors have short attention spans and are afraid of commitment.

Endocrinologists get their jollies by sitting alone in cramped offices, parsing tremendous volumes of laboratory data from blood tests, which they claim reflect moment-to-moment variations in hormone levels, and from this arcane evidence are able to parse out (so they say) subtle glandular difficulties. If endocrinologists were not physicians they would be accountants; the more aggressive endocrinologists (who are identifiable by the dirty glance they give you if you happen to interrupt their lonely cogitations) might be forensic accountants. (How anybody could specialize in any organ that just sits there, perhaps secreting various invisible substances, but otherwise not doing anything whatsoever,  DrRich will never understand.)

Orthopedic surgeons are former jocks, or wish they were, and the ones who end up replacing hips in old ladies instead of patrolling the sidelines at college football games are often very frustrated individuals.

Party animals who manage to gain entrance to medical school often end up as anesthesiologists.

Cardiologists like to envision themselves (and would like others to envision them) as living on the edge. After all, they put catheters into damaged coronary arteries in patients on the brink of heart attacks, and, through their skillful manipulations, open those arteries and save lives. They are the extreme sportsmen of medicine, so they believe. But really, their jobs are ones of relative security, predictability and instant gratification. What they do in the cath lab actually is pretty rote, and it provides them with immediate, concrete results. They can even show the “before” and “after” pictures to the person they just saved, who will then heap praise and shed tears of gratitude upon them. But any time fixing a particular artery looks a little too risky, they call a cardiac surgeon right away. This pattern of behavior suggests to DrRich that their aggressive personnas and glory-seeking activities are actually masking an underlying insecurity.

It would not be fair of DrRich to psychoanalyze all these other specialists – who have done nothing to provoke him – without also doing the same for electrophysiologists. All electrophysiologists started out as cardiologists, of course, so they have that going for them. But to really understand electrophysiologists, one must invoke the principle of sublimation. To sublimate is to channel an underlying negative tendency to some activity that partially gratifies that tendency, but that is considered worthwhile by society. So, for instance, people with a tendency toward pyromania may become volunteer firefighters. People with sadistic tendencies may become prison guards. Foot fetishists can become shoe salesmen. Compulsive liars can become novelists.

Who, then, become electrophysiologists?

Back in the 1980s and 1990s, when DrRich was practicing, what electrophysiologists mainly did was to try to prevent sudden death in patients who had a high risk of dying suddenly from cardiac arrhythmias. And in order to find the optimal therapy for these patients, it was necessary to induce, intentionally and repeatedly, cardiac arrests under controlled conditions. This was done in an effort to find an antiarrhythmic drug that would prevent the induction of cardiac arrest. This behavior we euphemistically called “serial drug testing.”  Fortunately, this procedure is no longer necessary, since the implantable defibrillator has been perfected and is now widely available for high-risk patients (if you can get it paid for).

While it has been widely remarked that those early-day electrophysiologists were a very strange group indeed, most of us who did this serial drug testing ended up successfully absorbed into normal society, and today (as far as DrRich can tell) we are for the most part generally pretty harmless. But DrRich sometimes finds himself wondering what might have become of some of us (some in particular more than others) if we had not had this remarkable opportunity to sublimate what one might speculate to be some rather unpleasant tendencies. And what is to become of that young person today who has whatever those unfortunate tendencies might be, and who, 30 years ago, might have found release as an electrophysiologist? One must not think too deeply about this.

Let us now turn our attention to those would-be GOD panelists, and see if we can decipher what kind of people these might be. Admitting that what follows – and, for that matter, what has just been said – amounts only to an educated guess, DrRich submits that the GOD panelists are people you already know well, if you have worked within the American healthcare system.

These are the kids you knew in college who studied all the time and got straight A’s in all the hardest courses, buttered up their teachers, then aced their MCATs. For them the hardest part about applying to medical school was in deciding which of the many schools that accepted them they should attend. Likely, they chose one of the Ivy League ones. Their first two years of medical school – the didactic years – were much like their college experiences. They studied hard, aced all the exams, and were generally acknowledged by both faculty and peers to be at the very top of their class.

Then they reached their clinical years, and things changed. They still knew more information than anyone else, and in fact their information base continued to expand. They read all the journals, and could always quote new research findings chapter and verse. They could conjugate the Krebs cycle on demand (or whatever it is you do with the Krebs cycle), and could recite precisely which enzyme that new drug inhibited, and could say why doing so made it OK to eat pizza again.

But what they could not do was be a good doctor. They had no instinct for it; no ability to get the patients to tell them the important information; no ability to read a patient’s facial expression, or phraseology, or body language, those signs that reveal the real truth. They had no ability to discern useful information from the flood of partial and contradictory clinical evidence that is always pouring in from several sources. When time was of the essence, they had no capacity to figure out what was going on or what they should do about it. They could not adjust to changing clinical situations on the fly. In an emergency they were paralyzed, trying to match the quickly evolving situation in front of them with the static words on the printed page. And often they were klutzes.

They were perfectly cut out to learn medicine, but lousy at actually doing it. What was worse, some of their colleagues who were mediocre in the book-learning department suddenly blossomed into highly competent clinicians on the wards, and quickly became recognized as rising stars by attending physicians, while they themselves were repeatedly chastised, or ignored.

And it just wasn’t right. It just wasn’t fair. They had worked harder than everyone else, had twice the brains as those others, and had learned the material three times as well. But the way God set it up, they just weren’t good doctors.

Many of these unfortunate souls quickly left clinical medicine, and branched off into research, academics, or administration. Most of them did quite well for themselves, because they really are very smart. But they never really got over their frustration and anger over their unjust  failures on the clinical wards, a place where their obvious inferiors lorded it over them. They have now spent years engaging in cognitive dissonance, convincing themselves that their apparent failure was an illusion, merely a sign of having been subjected to the anti-intellectual, shoot-from-the-hip, do-it-quickly-and-make-more-money environment that is American healthcare. After all, how could they be sub-optimal physicians when they are clearly far more intelligent and knowledgeable than the supposed “stars?” If the healthcare system had been arranged differently, in such a way as to make the cowboys behave the right way, they would have proven themselves to be the best clinicians in the land.  It is a bitter, bitter pill.

These are the guys, DrRich thinks, who are chomping at the bit for the opportunity to sit on the GOD panels. They would dearly love the chance to utilize their superior intellectual firepower, to distill the clinical research data, to digest it painstakingly and thoroughly (not haphazardly and on the fly like those others), to put down on paper the RIGHT way of practicing clinical medicine -  and to have the authority to do it in such a way (backed up by the full force of the Central Authority) that those lesser doctors will HAVE to do it their way, at long last.

The point of all this psychoanalytic guesswork is to suggest that the GOD panelists, even the GOD panelists who are physicians, will have no sympathy for the idea that the practice of medicine should be individualized to any degree whatsoever. The idea of individualizing medical care, rather than practicing by formula from a book, is what caused these people the most uncomfortable moments in their professional lives. Far from being sympathetic to the idea, they will probably be more hostile to it than the non-physicians on the GOD panels. When somebody on the panel suggests that, perhaps, we should give the doctor a little more leeway on this particular issue, these physicians will speak up and say, “Listen. I’ve been there and you haven’t. These doctors don’t need any more rope, unless it’s to bind them even tighter.” They were themselves shown no quarter, in the tough arena of clinical medicine where outcomes (and not process or book knowledge) is the only mark of success, and they will offer none in their turn.

DrRich cannot prove any of this, of course. He is just theorizing, based on his own personal observations and prejudices, having observed many of these whiz-kids in his 25 years of teaching medical trainees, and watching where they wound up. He could, of course, be wrong.

In any case, for allowing him to carry on in this manner DrRich owes one more expression of gratitude to his Progressive friends, whose doctrine of Diversity supplies the necessary substrate, and the ethical “cover,” for mercilessly stereotyping selected groups of what otherwise might turn out to be individuals.

Podcast:

In quainter times, medical “guidelines” merely meant a set of general principles which doctors ought to keep in mind when deciding on the most appropriate medical care for their patients. But in recent years guidelines have come to represent reasonably firm expectations for medical practitioners. And doctors who fail to closely follow guidelines may not be looked upon favorably any more by insurance companies or Medicare.

Obviously, then, since the guidelines finally determine who gets what, when and how, controlling the guidelines (i.e., making sure the guidelines say what you want them to say) has become important to any interest group within the healthcare system. And nobody understands the critical importance of guidelines better than cardiologists, a group of which DrRich is a proud member.

In a valiant attempt to carve out as much turf for themselves as possible within a healthcare system driven by guidelines, cardiologists, through their powerful professional societies, have been vigorously fighting the Guideline Wars for two decades – well before most other medical specialties even recognized that a war was being fought. This long struggle has lent to the cardiology profession a certain level of experience and sophistication that may help them to preserve some of their hard-won turf, even as we move into a far more dangerous phase of the Guideline Wars, in which less robust specialties risk debilitation, and even extinction.

For, under Obamacare, guidelines are now to become far more than mere guideposts, or principles, or even strong expectations. They are to become handed-down and inviolable rules which will dictate the details of proper patient care, and which doctors must follow to the letter. Following this new species of guidelines as closely as scripture will be necessary for any doctor who wants to be officially tabulated as a “physician of quality,” who desires to be paid the going rates, and who would prefer to avoid fines or imprisonment for fraud (fraud being, of course, the failure to practice medicine according to the guidelines).

Whereas until now the Guideline Wars have been largely fought among various medical specialties competing for turf, from now on the major combatant in these wars will be the federal government. Under Obamacare, the official medical guidelines will no longer be determined by conflicted medical specialty organizations (which will always try to establish guidelines that cause the healthcare system to spend lots of money on their specialists), but instead by government panels, which will have their own obvious conflicts of interest.

Most observers of the healthcare system seem congenitally unable to recognize that a government bent on controlling the behavior of its citizens (in order to create the perfect healthcare system, which, in turn, is a necessary component of a perfect society) will be working under, if anything, more conflicts of interest than any other healthcare entity.  In particular, the government, and by extension its appointed panels, will be desperate to the point of apoplexy to avoid spending any money, at any time, for any medical services, any time they can get away with it. So ultimately, the widespread proposition that the government panels will be entirely free of any particular agendas, or conflicts, or prejudices, as they hand down the rules of medical engagement to physicians, is balderdash.

The abiding conceit of the government panelists, of course, is that they will behave in an entirely objective manner in rendering the guidelines of medical practice, and will simply follow the science wherever it may lead, without any prejudice whatsoever. That is, they will not actually create the guidelines, but will simply “discover” them, through the objective application of clinical science. In other words, under Obamacare, the “true” medical guidelines will be handed down not by flawed men saddled with conflicts of interest, but by the inherent properties of nature. The government panels will simply be interpreting nature, and will do so, unlike those conflicted physicians, without prejudice.

Indeed, DrRich will go so far at to point out that the Obamacare guidelines will come from GOD – Government Operatives Deliberating. Readers who think it is in poor taste to refer to these individuals – who will invent the guidelines which will determine life and death for so many of us – as GOD panelists should be reminded that other, less sensitive individuals have tried to label them “death panelists.” DrRich’s nomenclature is not only more descriptive, but is much kinder.

In any case, this is where cardiologists have a tactical advantage over most medical specialists as we enter the Obamacare phase of the Guideline Wars. For, in their decades-long struggle in those wars, cardiologists have discovered something that more naive and inexperienced medical specialists, as well as academics, and even most government advisers, are only dimly aware of. Namely, that there is no such thing as the objective application of clinical science. Inevitably, interpreting clinical science – which is among the most inexact of the sciences – incorporates inherent bias.

That bias can be applied either subconsciously or consciously, but one way or another it is applied. And the advantage the cardiologists have over other medical specialists is that they understand that, to have a better chance of getting what they want, they need to direct the application of bias in interpreting critical clinical trials, and they must do it aggressively.

At the highest levels, of course, the agents of the government understand the very same thing. This is why they are setting up their own panels to control the guidelines in the first place. And you can be sure they will choose their panelists carefully.

But DrRich (and his cardiologist friends) know that when the government panelists are being sworn in, they will not be told their true mission in stark terms. They will not be told, “Your job is to twist the eminently-twistable clinical data in any way you must in order to reduce spending on healthcare, no matter who is hurt by it.” This charge would be unacceptable to most of the individuals the government would prefer to choose as panelists, namely, proud and accomplished individuals with valued professional reputations to uphold (though, to be sure, with a proven track record of thinking about clinical science with the kind of bias the government appreciates).

Rather, the panelists will be told:

“Panelists! You have perhaps the most critically important job in all of healthcare, namely, reining in the counterproductive, harmful, wasteful activities of the self-serving medical profession, which is married to greed, and beholden to its evil partners in medical industry. Your job is to lead doctors (most of whom would do the right thing if they can be shown the way in a sufficiently forceful manner) out of the wilderness, and bring them to the path of righteousness. For we hold these truths to be self-evident: that good medical care is efficient medical care; indeed, it is parsimonious medical care; and this being the case, the proper interpretation of clinical science will virtually always show us that less is more. It is your job to interpret clinical science in that proper way, to show American physicians how to fulfill their primary moral obligation to the greater health of the collective.”

DrRich has already demonstrated that there are plenty of physician-ethicists in very high positions who completely buy this stuff. It will be no problem for the Feds to find as many of them as they want to populate the GOD panels, and indeed candidates are virtually tripping over each other to audition.

In any case, their government handlers will reassure all the panelists that they simply are to follow the science, while establishing very strong expectations as to where properly-applied science will inevitably lead. This procedure will be aimed at allowing panelists to maintain the soothing and necessary fiction that they are, in fact, functioning as unbiased agents of reason and logic, and are well-deserving of public adoration, and perhaps even of self-respect.

Cardiologists, battle-hardened Guideline Warriors that they are, understand the position in which the new GOD panelists will find themselves, and as a result they understand that the clinical science these panelists will use to fashion medical guidelines must not reach them in anything like a pristine condition. Rather, that clinical science must reach them “pre-spun,” with the “right” interpretations already spelled out for them by respected academic figures, and, to the fullest extent possible, already permeated into the public consciousness. Cardiologists hope that panelists will be relatively reluctant to make guidelines which are starkly opposed to such predisposed interpretations, for fear they will be found grating to professionals outside of government whose opinions they might value.

With such a strategy the cardiologists are perhaps clinging to a thin thread. It is, in fact, not much of a plan. But it beats whatever it is you gastroenterologists are doing.

In his next post DrRich will illustrate cardiologists’ new strategy of “pre-spinning” clinical trial data, in order to make it more difficult for GOD panelists to do them grave harm.

Podcast:

In a remarkable article that somehow* was accepted for publication in the Annals of Internal Medicine, the White House offered some friendly advice to American PCPs who may be wondering how Obamacare will affect them. That advice, to summarize, is: “We are the Borg. Prepare to be assimilated.”
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* DrRich is forced to wonder whether yet another group of medical editors is auditioning for the death panels.
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The article was written by Ezekiel Emanuel from the White House’s Office of Management and Budget, and Nancy-Ann M. De Parle, who is Mr. Obama’s Czar of Healthcare Reform. (A third author was from the McKinsey Group.) After reminding physicians of their moral obligation to the collective, the White House authors rhapsodized about all of the wonderful changes inherent in Obamacare that will help physicians to realize this obligation.

There’s actually no need to read the entire article, assuming you heard any of the 400 speeches President Obama delivered in his unsuccessful attempt to convince the public that his healthcare reforms ought to displace the holy writ as The Good News. The meat of the article, if you’re a physician, appears at the end:

These reforms will unleash forces that favor integration across the continuum of care. Some organizing function will need to be developed to track quality measures, account for and manage shared financial incentives, and oversee care coordination….These coordinating functions, to the extent that they currently exist, traditionally have been managed by hospitals or health plans….As physicians organize themselves into increasing larger groups — patient-centered medical home practices and accountable care organizations — they are, out of necessity, investing in information technology tools that are becoming both cheaper and more capable and investing in the acquisition or development of management skills that could provide these organizing functions efficiently for physicians groups….For physicians, this means a profession that is more rewarding, more productive, and better able to realize its moral ideal.

DrRich translates this message thusly: “Physicians! You have been neglecting your moral obligation to the collective, in favor of your archaic devotion to the individual patient. Under Obamacare you will need to join organizations which are devoted to the collective goals of Obamacare, and which therefore will guarantee the proper moral ideals. You must function not as individual decisionmakers, but as integrated cogs in a vast healthcare continuum, which will stretch from the centralized bastion of gleaming moral authority (from which we pen this message) all the way down to the humble tip of your stethoscope. You will be rewarded for your cooperation, or suffer for your resistance (resistance, of course, being futile).  So rejoice for the health of the collective, and for your own well-being, and prepare to be assimilated.”

Ostensibly this message is for all American physicians, but it was submitted to the Annals of Internal Medicine for a reason. The Annals is the journal of record for doctors who practice internal medicine, and who comprise the largest group of PCPs. The White House in this article is speaking directly to American PCPs.

This is because PCPs pose the greatest short-term threat to Obamacare.

Most medical specialists have already been “assimilated.” Because they require lots of expensive stuff to practice their specialties – things like gamma cameras, operating suites, catheterization laboratories, hordes of highly trained medical technicians, &c. – it is very difficult for most specialists to function as independent operators. If you want medical specialists to follow the rules, all you have to do is make following the rules a requirement for keeping their access to all the technology and the complex infrastructure they need to practice their specialties.

Only PCPs can fairly readily make themselves independent from the collective.  And more and more PCPs are choosing to do so.

The White House does not like this.  The Annals article, DrRich thinks, is the administration’s first official attempt to curtail the PCPs’ fledgling independence movement. The threat is veiled – the article instead appeals to the PCPs purported moral obligation to the collective, and emphasizes the rewards that will follow when PCPs allow themselves to be assimilated into the Borg.

So this first attempt, for the most part, is merely creepy. The next step will not be as benign.

DrRich urges his PCP friends to take heed. If you have any thought of striking out on your own, and starting a direct pay practice – thus reasserting your profession’s real moral obligation, which is to your patients – you had better act now, before it becomes a federal crime to do so.

Podcast:

DrRich’s last post addressed a recent issue of the Archives of Internal Medicine which, strikingly, was largely dedicated to trashing the JUPITER study.

The JUPITER study was a landmark clinical trial in which giving the statin drug Crestor to apparently healthy individuals who were at increased risk of cardiovascular disease (and most particularly, had high CRP levels) resulted in a significant improvement in outcomes. In particular, within two years, individuals taking the statin had a 20% reduction in overall mortality, a 54% reduction in heart attacks, a 48% reduction in stroke, and a 40% reduction in venous thrombosis and pulmonary embolism. All these findings were highly statistically significant.

DrRich attempted to show that the criticisms of JUPITER recently offered by the Archives were sufficiently spurious to raise the question of what the authors and the editors were really trying to accomplish, and for him to suggest that perhaps they were auditioning for appointments to the government’s expert medical panels, which will soon begin determining who gets what, when and how. Indeed, DrRich will actually be quite surprised if none of these individuals end up with such an appointment. They have clearly demonstrated they have the right stuff.

Still, as DrRich also pointed out, the JUPITER study, while a reasonably straightforward clinical trial whose results seem impressive, was anything but air-tight. No clinical trial is air-tight, however, and if medicine were still practiced the way it should be, the JUPITER trial could be smoothly incorporated – with all its limitations – into clinical practice without a hitch.

But, since medicine is now practiced by guidelines, JUPITER poses a major problem. In fact, it has led to major and contentious debates between those who insist its results must be incorporated into formal clinical guidelines, and who insist they should not. On one hand, many point out that JUPITER is an important clinical trial which has demonstrated a vital clinical benefit (prevention of heart attack, stroke and death) with a high degree of statistical significance, which meets the high standards demanded by evidence-based medicine, and which therefore obviously demands a change in the clinical guidelines. But on the other hand, many others insist that the JUPITER trial simply does not demonstrate enough of a benefit with Crestor to justify changing the guidelines.

DrRich’s position – that the results of the JUPITER trial are striking and important but incomplete, and ought to change the conversation between, but not dictate the actions of, doctors and patients – simply does not obtain in the modern era.

So, unable to side with either party, DrRich observes with great interest the debate between those who want to change the guidelines, and those who believe that changing the guidelines would be the greatest of travesties.

Those who want to change the guidelines have, in their favor, the virtue of consistency. For, if one insists that every action by physicians must be supported by evidence-based medicine, then one is pretty much obligated to fully embrace legitimate clinical trials like this one that give clear-cut and statistically significant results. Unfortunately, the evidence-based strict-constructionists have painted themselves into a corner when it comes to JUPITER. They will not be able to say, for instance, “Statins are pretty much alike, so we’ll make the guidelines say ‘statins’ instead of ‘Crestor.’” For JUPITER did not study “statins,” it studied only Crestor, the most expensive statin on the planet. Expanding the results to all statins (despite a large body of experience that suggests this would be just fine) does violence to the whole concept of evidence-based medicine. It’s just not possible. The strict constructionists have therefore boxed themselves in to advocating a new, multi-billion dollar annual expenditure.

It is even more amusing to observe those who do not want to change the guidelines.

These people fall into two general camps. First, and easier to dismiss, are those who believe that drug companies are the embodiment of evil, and that any clinical trial sponsored by a drug company must be dismissed out of hand, particularly if the drugs which are being promoted are statins. (This, in fact, is the level of argument on which the main article in the recent issue of Archives relies.)

DrRich simply notes, once again, that the advancement of clinically useful medical science – in America and in the world – is almost entirely dependent on drug companies and other corporate dens of iniquity. That companies must pay for our medical research is the system we’ve invented. Furthermore, our total capitulation to the dictates of evidence-based medicine means that companies must fund large, expensive clinical trials like JUPITER before they are allowed to sell a new product, or to create a new indication for an old product. This evidence-based paradigm is inherently a double-edged sword. Sure, it creates a huge barrier to the development and adoption of expensive new therapies (which is the covert rationing dividend of evidence-based medicine), but it also creates opportunities, for companies who manage to successfully complete such trials, to create iron-clad indications for their products. For, once a product has been “proven” in a randomized clinical trial, there is no easy way to legitimately keep that product out of the guidelines and off the shelves. The makers of Crestor have simply figured out the rules. One can whip up anti-corporate emotions by criticizing the sponsor for playing the game well, but the fact that the sponsor stands to gain does not negate in any way the results of a well-designed study.

That the anti-pharmaceutical and anti-statin crowds vociferously object to the results of the JUPITER trial is, of course, entirely expected and cheerfully acknowledged. DrRich will merely observe that their position is one of default. It is not dependent on the scientific merit of JUPITER (or any company-sponsored study), and thus it adds no useful information to the debate. We can only note their objections and move on.

The second group of people who object to changing the guidelines are less dogmatic and more open to reason, and indeed (and very interestingly so) claim to be proponents of evidence-based medicine, and thus claim to be willing to follow the data to where it will lead. It seems pretty clear (to DrRich, anyway), that the chief concern of these individuals, as it relates to JUPITER, is cost. That is, this group feels strongly that the implications of the JUPITER trial are simply too costly to follow to their logical conclusion. This, indeed, is a very reasonable position to take.

Unfortunately, the only legitimate way to turn aside the results of a costly but statistically definitive, evidence-based study is by rationing healthcare. (To ration, remember, is to withhold at least some useful medical services from at least some people who would be likely to benefit from those services.) But we can’t do that, because, well, it would be rationing. Because members of this second group are unable to invoke the “r” word, they are therefore forced to find other “reasons” for keeping the guidelines unchanged. This unfortunate situation leaves them little choice but to discover ways in which to impugn the legitimacy of the JUPITER trial.

In short, they find themselves forced to engage in statistical legerdemain in order to diminish the significance of the JUPITER trial. There are several useful statistical arguments they can employ.

From what DrRich has seen, many of the arguments that have been ginned up to this end have not come directly from the JUPITER trial itself, but instead from an editorial accompanying this study, written by Dr. Mark A. Hlatky.

Most of Dr. Hlatky’s editorial is measured and reasonable. But he threw in a key summary sentence that has been greedily grasped by the anti-alter-guidelinetarians, to wit: “The proportion of participants with hard cardiac events in JUPITER was reduced from 1.8% (157 of 8901 subjects) in the placebo group to 0.9% (83 of the 8901 subjects) in the rosuvastatin [Crestor] group; thus, 120 participants were treated for 1.9 years to prevent one event.”

This statement, at least taken at its face value as a stand-alone analysis, is statistically naive and wrong. DrRich realizes that one or two of his readers might not enjoy statistical arguments, so if you do not wish to wade through the reasons why, simply skip the next two indented paragraphs.

In a long-term clinical study in which the endpoints are events that can occur at any time (such as heart attack, stroke or death), then the probability that an enrolled patient will reach an endpoint in the trial increases the longer he/she has been enrolled in the trial. But in virtually all clinical trials, the length of time different people are enrolled varies greatly. This is because it often takes years to enroll people in clinical trials, so that when the trial ends, some will have been in the trial for many years, others for only a little while. This means that the risk exposure of each research subject is different, and is proportional to the total time they were enrolled. Not uncommonly, the enrollment process is not smooth – there are periods of more rapid enrollment, and periods of slower enrollment – so if all you do is average the enrollment time (as was done by Hlatky – 1.9 years) you are likely to get skewed results. So it is simply not statistically legitimate to do so.

There is a legitimate way of analyzing such longitudinal outcome statistics, and it’s called the Kaplan-Meier method. And indeed, the authors of the JUPITER trial presented in their paper a complete Kaplan-Meier analysis of their data (see Figure 1 of their paper), and the results look quite a bit different from Hlatky’s summary statement. The Kaplan-Meier analysis reveals that the risk of heart attack, stroke, and death all increase steadily through at least 4 years (5 years was the longest time anyone was enrolled in this study), so that at 4 years, the risk of reaching one of the “cardiovascular event” endpoints was about 8% (not 1.8%). Further, the Kaplan-Meier analysis shows that the protection imparted by Crestor persists through at least 4 years, and that indeed the magnitude of protection (i.e., the difference in outcomes between the treated group and the placebo group) increases throughout that entire duration. So, at 4 years, the placebo group had roughly an 8% event rate, compared to roughly a 3% event rate for the Crestor group – an absolute difference of about 5% (not 0.9%). This is a far greater benefit than is suggested by Hlatky’s shorthand summary.

Suffice to say, then, that Hlatky’s summary statement apparently ignores the appropriately analyzed data which is clearly presented in the JUPITER paper itself, and which documents that the clinical benefit of Crestor was substantially more impressive than his widely-quoted summary statement suggests.

But as illegitimate as this summary statement may be, let us accept it at face value for a moment just for the sake of discussion, since that’s the data the anti-alter-guidelinetarians have latched on to.

Taking these numbers, the “antis” make the following argument: While the relative reduction in “hard cardiac events” is 50% (1.8 to 0.9), the absolute reduction is only 0.9%, which, anyone would agree, is a pretty small number. So, they conclude, the actual benefit imparted by Crestor is actually quite small.

That’s a very interesting argument. Let’s look at it in a couple of ways.

So we’ve got a population of patients whose risk of heart attack, stroke, bypass surgery/stenting, or death is about 2% at about 2 years, and by giving them a pill we can reduce that risk to about 1%, and we’re arguing that the absolute drop of 1% is not very much to crow about. Well, OK. But what if we found a pill that reduced their risk to zero at 2 years? That is, it completely wiped out the risk of cardiovascular catastrophes altogether. Would that be a good thing? Or would we say, “It’s just a 2% drop, really not much greater than the 1% drop we had with Crestor, so it’s no big deal?” DrRich thinks not. DrRich supposes we would think that totally eliminating all cardiovascular risk would be a very big deal.

When you’re starting at a 2% risk, then any drop in risk is going to be an “absolutely” small number. And if we’re not going to pursue improvements in outcome of such a small magnitude, then why the heck are we worrying about preventative medicine in the first place? Once you get past the big things (drain the swamps, don’t drink the water downhill from the outhouse, etc.) then all preventative medicine tends to consist of small, incremental improvements in outcome. Popular pronouncements to the contrary notwithstanding, preventative medicine is largely the art of spending a lot of money for this kind of incremental improvement. If we decide we shouldn’t do this anymore, then DrRich would find it unfortunate but understandable. But it hardly seems reasonable to arbitrarily focus on this one, particular improvement in preventative cardiology, and (within a healthcare system that insists it is not rationing care) pronounce that this is the one we’re not paying for.

Another way of looking at this “the benefit is too small” argument is by considering that 7.4 million Americans fit the entrance criteria for JUPITER. By giving all these people a statin, we would be preventing about 66,600 major cardiovascular events over a 2 year period. If you’re going to say that 1% is a small number, DrRich will counter that 66,600 is a big number. So do statins offer a substantial benefit or not? It depends on whether you choose to focus arbitrarily on the 1% or the 66,600.

(DrRich understands that many of his readers are not focusing at this moment on the 66,600 cardiovascular catastrophes that could be prevented, but on the 7.4 million people who will be taking a drug that costs $120 per month. But we’re not talking about cost yet, we’re only talking about whether the drug does some good. If we decide it does, then we’ll need to link that “good” to a procedure that measures whether the “good” is worth the money we would need to spend to achieve it. The “antis” try to avoid talking about cost – since that would admit they’re rationing – by insisting that there’s just not enough “good” to bother with. DrRich is simply pointing out that such an argument – that preventing 66,600 very bad outcomes is not enough to bother with – is on its face absurd.)

Another argument invoked by the anti-alter-guidelinetarians is based on the “number needed to treat” (NNT) analysis. Again they rely on Hlatky’s unfortunate summary of the data: “120 participants were treated for 1.9 years to prevent one event.” This number – which the “antis” insist is just too high – is misleading for the reasons already discussed. The real NNT, based on more legitimate statistical analysis, is plainly laid out in the JUPITER paper itself. It turns out that the longer patients in this trial were treated with Crestor, the lower the NNT became. So: At 2 years, the NNT was 95; at 4 years, it was 31; and at 5 years, it was projected to be only 25. Whether you think it is reasonable to treat 25 people with a pill for 5 years to prevent one of them from having a heart attack, stroke, or death is, DrRich supposes, a matter of opinion. But based on NNT analyses for many widely-accepted therapies in medicine today, it looks pretty good.

All these arguments, of course, are merely distractions. The fact is that JUPITER showed a pretty striking reduction in nasty cardiovascular events over s pretty brief period of time, and the only real reason there’s any controversy at all is because of the cost of Crestor.

That cost is what makes us want to withhold Crestor, even though it is imparting at least some (and, DrRich, argues, quite a bit of) clinical benefit. In other words, the high cost makes us want to ration Crestor. The fact that we can only ration covertly, instead of openly, is what makes us want to bastardize the science and do a Kabuki dance with the statistics.

If we were rationing healthcare openly, then we could do an objective, full-bore cost-benefit analysis on the use of Crestor in JUPITER patients, using legitimate and not ginned-up statistical analysis, and taking into account not only the cost of the drug, but also the cost that would be incurred by failing to stop preventable heart attacks, strokes, etc., and then determining where the overall cost-benefit result fell within our coverage criteria. If it met the criteria we would cover it, if not, not. This decision would not be arbitrary. It would be a fully transparent process, so that if the sponsor did not like the results, they would try diligently to find a way to reduce the cost of Crestor (DrRich thinks they would succeed) to a value that would be compatible with their staying in business. (And for the first time, the price of medical products would be determined by a Laffer-like curve, where a price that was too high – like taxes that are too high – would reduce revenue, instead of increase revenue. Companies, being fairly rational, would ratchet their prices down to the optimal price point.)

But since we insist on doing our rationing covertly, DrRich is sorry to say that we’re destined to keep making spurious arguments, and using dumbed-down statistical analysis to back them up. The JUPITER trial, while it is imperfect and while it does not answer every question, really is pretty straightforward. That we get so wrapped around the axle trying to fold such clinical trials into our covert rationing paradigm is simply another demonstration of the fact that covert rationing corrupts everything it touches.

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Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

Podcast:

This week, the Archives of Internal Medicine published four (four!) articles assaulting the legitimacy and the importance of the JUPITER trial, a landmark clinical study published in 2008, which showed that certain apparently healthy patients with normal cholesterol levels had markedly improved cardiovascular outcomes when taking a statin drug.

Superficially, at least, the JUPITER study appears to have been pretty straightforward. Nearly 18,000 men and women from 26 countries who had “normal” cholesterol levels but elevated C-reactive protein (CRP) levels were randomized to receive either the statin drug Crestor, or a placebo. CRP is a non-specific marker of inflammation, and an increased CRP blood level is thought to represent inflammation within the blood vessels, and is a known risk factor for heart attack and stroke. The study was stopped after a little less than two years, when the study’s independent Data Safety Monitoring Board (DSMB) determined that it would be unethical to continue. For, at that point, individuals taking the statin had a 20% reduction in overall mortality, a dramatic reduction in heart attacks, a 50% reduction in stroke, and a 40% reduction in venous thrombosis and pulmonary embolism. All these findings were highly statistically significant.

This study is noteworthy because it is the first large randomized trial to show that taking a statin can markedly reduce the incidence of some very nasty cardiovascular outcomes in people who are considered to have “normal” cholesterol levels. (Notably, typical LDL cholesterol levels among primitive hunting/gathering cultures is around 50 mg/dL, instead of the 100 – 120 mg/dL we consider to be normal. These primitive folks have an extremely low incidence of cardiovascular disease, so maybe humans’ optimal cholesterol level is much lower than we now think. On the other hand, the low risk of cardiovascular disease among hunters/gatherers may instead be related to the fact that many of them are consumed by various species of carnivores before they’re 30.)

To be sure, the JUPITER trial was far from perfect. Because of its design, it could not (and did not) tell us whether the beneficial outcome is specific to Crestor, or is a class effect of all statins (which seems very likely). It did not tell us whether reducing CRP levels is itself beneficial, or even whether using CRP as a screening tool is actually helpful. (The people enrolled in this trial tended to have several other risk factors, such as being overweight, having metabolic syndrome, and smoking, and it is not clear how much additional risk elevated CRP levels really added in this population.) And this trial did not tell us the risks of lifelong, or even very long-term, Crestor therapy.

But JUPITER did tell us something that is very useful to know, and with a very high degree of statistical surety: Giving Crestor to patients similar to the ones enrolled in this study can be expected to result in significantly and substantially improved cardiovascular outcomes, and in a relatively short period of time.

If medicine were practiced the way it ought to be – where the doctor takes the available evidence, as imperfect as it always is, and applies it to each of her individual patients – then the incompleteness of answers from the JUPITER trial would present no special problems. After all, doctors never have all the answers when they help patients make decisions. So, in this case the doctor would discuss the pros and cons of statin therapy – the risks, the potential benefits, and all the quite important unknowns – and place the decision in the perspective of what might be gained if the patient instead took pains to control their weight, exercise, diet, smoking, etc. At the end of the day, some patients would insist on avoiding drug therapy at all costs; others would insist on Crestor and nothing else; yet others would choose to try a much cheaper generic statin; and some would even opt (believe it or not) for a trial of lifestyle changes before deciding on statin therapy. In other words, there is a range of reasonable options given the limitations of our knowledge, as there often is in clinical medicine. As time goes by, more scientific evidence is often brought to bear and clinical decisions can become more informed. But whatever the state of the evidence, doctors and patients can generally get by without violating too severely any ethical or medical precepts that would cause objective and neutral observers to complain very much.

But in recent years, and especially now, as we bravely embark on our new healthcare system, this is not how doctors will practice medicine. Instead, they will practice medicine by guidelines. These guidelines (which, in modern medical parlance, is a euphemism for “directives”) are to be handed down from panels of experts, identified and assembled by members of the executive branch of the federal government.

And this makes the stakes very high when it comes to a clinical trial like JUPITER. For guidelines do not permit a range of actions tailored to fit individual patients (consistent with the uncertainties inherent in the results of any clinical trial). Instead, guidelines will seek to take one of two possible positions. That is, under a paradigm of medicine-by-guidelines, the results of clinical trials generally cannot be permitted to remain imperfect or nuanced or subject to individual application, but must be resolved by a central panel of government-issue experts into a binary system – yes (do it) or no (don’t do it). In the case of JUPITER, the guidelines must decide whether or not to recommend Crestor to patients like the ones enrolled in the study, at a potential cost of several billion dollars a year. It should be obvious that the answer which would be more pleasant to the ends of the central authority, and  by a large margin, would be: No, don’t adopt the JUPITER results into clinical practice.

However, the expert panels which are called for by our new healthcare legislation have not been formulated yet, and we are still operating under the “old” rules. So, still subject to all the duress which is created by unfortunately-resolved clinical trials like this one, the FDA, somewhat reluctantly, approved the use of Crestor for JUPITER-like patients in late 2009. That approval, of course, is subject to review by the new expert panels, whenever they are assembled.

This, DrRich submits for your consideration, is likely what instigated the almost violently anti-JUPITER issue of the Archives this week. DrRich theorizes that what we’ve got here is a bunch of wannabe federally-sanctioned experts, auditioning for positions on the expert panels. What better way to get the Fed’s attention than to let them know that you are of the appropriate frame of mind to assiduously seek out scientific-sounding arguments to discount the straightforward and compelling, but fiscally unfortunate, results of a well-known clinical trial?

Of the four papers appearing in this week’s Archives, three are more-or-less legitimate academic articles that make reasonable points, but do no harm to the main result of JUPITER. The fourth is a straightforward polemic, which has no place in a peer-reviewed medical journal, and whose very presence, DrRich believes, very strongly suggests that the editors of the Archives themselves must be auditioning for the Fed’s expert panel.

So as not to bore his readers any more than necessary, DrRich will make short work of the three reasonably legitimate articles in this issue. One pointed out that JUPITER did not tease out the real importance of CRP levels, or whether lowering those levels is useful. This is true, but that fact does not touch the main conclusion of JUPITER. Another article was a meta-analysis which incorporated several other primary prevention trials using statins, and concluded that there is no overall benefit to statins in primary prevention patients. Aside from the usual problems inherent in meta-analyses, a) the JUPITER study looked at a specific population of primary prevention patients not addressed by these other studies, and b) since JUPITER is the first study to show a benefit in using statins for primary prevention, it is a foregone conclusion that if you assemble enough of the previous, negative studies and lump them together with JUPITER in a meta-analysis, you will be able to dilute the results of JUPITER sufficiently to achieve an overall negative result. Actually doing such a meta-analysis, then, is merely an exercise in math, not in revelation.

The third article criticized the JUPITER DSMB for stopping the trial earlier than originally planned. The DSMB, however, had no real choice in the matter – ethically or legally – given the striking statistical significance of the benefit seen with Crestor. When a patient signs an informed consent agreement to participate in a clinical trial, part of that “contract,” a part required by law, is the statement to the effect that if information comes to light during the course of the study that might impact a patient’s willingness to continue participating, that information must be made available. The fact that the Crestor branch of the study was found to have markedly improved survival, fewer strokes and heart attacks, etc., than the placebo branch, clearly constitutes such information. Stopping the study when they did was not “premature;” continuing the study would have been illegitimate. This is why independent DSMBs exist in the first place – to protect the rights and welfare of the research subjects under the fiduciary agreement that comprises informed consent.

The fourth article is more striking (and more fun) than the other three. Interestingly, it is categorized by the Archives as an “Original Investigation,” despite the fact that it describes no investigation of any kind whatsoever – original or derivative. It merely revisits the data from JUPITER (in a spectacularly biased manner), and offers a spate of ad hominem attacks, alleging bias to the point of corruption, without any supporting evidence, against JUPITER’s sponsor, its investigators, and most astoundingly, the chair of the DSMB (who is a well known and highly respected figure, especially known and revered for his complete objectivity and lack of bias). If such an article has any place at all in a peer-reviewed medical journal – which DrRich doubts – it ought to be clearly labeled as an opinion piece, and not as a piece of original research. Whatever it may be, it’s not that.

But the most delicious aspect of this fourth article is that two of its authors, including its lead author, are members of a fringe medical group known as The International Network of Cholesterol Skeptics (THINCS), whose stated mission is to “oppose” the notion that high cholesterol and animal fat play a role in cardiovascular disease. Members of THINCS also take an extraordinarily strong position opposing statins for any clinical use whatsoever. (One might actually assume that, since JUPITER shows that cardiovascular outcomes can be improved by statins in people with normal cholesterol levels, the THINCS would embrace the study as evidence that perhaps cholesterol is not as important as it’s cracked up to be. But apparently, this argument is completely negated by the fact that statins were the vehicle for making it. Many in the anti-statin crowd would object to statins even if they were proven to cure heart disease, cancer, baldness, and obesity AND produced fine and durable erections upon demand.)

The best part of all this is that the astounding anti-cholesterol, anti-statin bias of the authors was not disclosed in their article – whose main thrust, again, was to criticize the disclosed biases of the JUPITER investigators.

The excellent Pharmalot blog noted this irony, and contacted Rita Redberg (editor of the Archives) and Michel de Lorgeril (THINCS-master and prime author of the fourth article) to ask them why the association with THINCS was not disclosed.

Redberg:

“I’m not clear this is an undisclosed conflict. The policy mentions a personal relationship that could influence one’s work. I think that could be a big stretch. My initial impression is the group has an intellectual message, but doesn’t fit as a personal relationship that could effect the authors’ work.”

de Lorgeril:

“[While it is] very important to disclose financial [emphasis DrRich's] conflicts of interest that can influence our way of working and thinking about cholesterol and statins, there is so far no obligation to provide a CV each time we publish any thing…May I underline the fact that being a member of THINCS – not a group of terrorists, mainly a club of very kind retired scientists with whom I have interesting and open discussion – is not a conflict of interest?”

DrRich may be old fashioned, but he thinks that being a member of an “out there” group like THINCS, which appears to advance selected and distorted data on its website aimed at furthering its stated mission of “opposing” (not investigating or questioning) the cholesterol hypothesis and the use of statins, might make one prone to a bit of bias when writing a broadside critiquing a study like JUPITER, and loudly criticizing anyone associated with that study for their bias. This sort of bias (demonstrably rooted in a willingness to select/ignore/distort data in order to make a preconceived point) is likely to be as strong as any that might accompany, for instance, receiving a stipend from a statin company for participating in clinical research. Membership in THINCS may not preclude one from writing such an article, but DrRich thinks the association at least ought to be disclosed, just as financial relationships must be disclosed.

DrRich has a hard time explaining how this can happen with a prestigious medical journal like the Archives. But like Sherlock Holmes says, when you have eliminated the impossible (such as, the idea that this article deserved to be published in its current form), whatever remains, however improbable, must be the truth.

And this is why DrRich can only conclude that several of the authors appearing in this week’s issue of the Archives of Internal Medicine, along with its editor, are in the mode of ingratiating themselves to the sundry officials and czars within the Obama administration who will be assembling the expert medical panels, those panels which will be making the momentous decisions that will determine the flow of hundreds of billions of dollars, and (forgive me) of life and death.

We wish them the best of luck in their audition, and will be monitoring the memberships of the new panels with interest, to see if any of our new friends are ultimately successful.

__

DrRich critiques more arguments for withholding Crestor here.

__

_Sources:

_{de Lorgeril M, Salen P, Abramson J, et al. Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy. A critical reappraisal. Arch Intern Med. 2010; 170:1032-1036.}

_{Kaul S, Morrissey RP, Diamond GA. By Jove! What is a clinician to make of JUPITER? Arch Intern Med. 2010; 170:1073-1077.}

_{Ray KK, Seshasai SRK, Erqou S, et al. Statins and all-cause mortality in high-risk primary prevention. A meta-analysis of 11 randomized controlled trials involving 65 229 participants. Arch Intern Med. 2010; 170:1024-1031.}

_{Green L A. Cholesterol-lowering therapy for primary prevention. Still much we don’t know. Arch Intern Med. 2010; 170:1007-1008.}

________________________________

Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

Last week, DrRich noted that the Covert Rationing Blog and the ACP Advocate Blog were named as co-finalists in 2009 Medical Weblog Award Competition, in the category of Best Health Policy/Ethics Blog. (Voting continues through Feb. 14.) DrRich, ever the opportunist, latched on to this fortuitous occasion to issue a challenge to Bob Doherty, author of the ACP Advocate blog, to engage in a debate over that very topic – medical ethics. He made this audacious challenge because the ACP is a chief signatory of a new code of “medical ethics for a new millennium,” formally promulgated in 2002 by an international group of medical professional organizations (a grouping DrRich has called – for convenience sake only – the Millennialists). And DrRich has taken great exception to this New Ethics, which, he asserts, does great damage to the doctor-patient relationship and to the medical profession. (DrRich details his objection to the New Ethics here, and describes the right way to do medical ethics here.)

A few days ago Mr. Doherty (who is also the ACP’s Senior Vice President of Governmental Affairs and Public Policy), graciously agreed to engage in this discussion, and promised to do so after consulting with the ACP’s Committee on Ethics, Professionalism, and Human Rights.

DrRich had hoped that Mr. Doherty would reply with a post on his ACP blog, which (since it likely has a vastly greater readership than the CRB), would more effectively give this topic some much-needed airing – and in particular, might engage some of the ACP’s membership (specialists in internal medicine) in this important discussion. DrRich was disappointed, then, when the reply came today in the form of a comment, which was tacked on to a long queue of reader’s comments at the end of DrRich’s posting.

DrRich was also very disappointed by the content of the reply which, fundamentally, was: This is a non-issue, and even if it was an issue, it’s now a settled issue. (So go away.)

Because he fears that his readers may not find the ACP’s response (buried as it is), DrRich will post it here in its entirety. But first he will very briefly summarize his complaint against the New Ethics promulgated by the ACP and other Millennialists. The New Ethics takes classical medical ethics (which obligates doctors to always place the welfare of their individual patients first) and adds on to it a new ethical obligation, called Social Justice, which obligates doctors to work toward “the fair distribution of healthcare resources.” This new obligation (which is to society) will inherently conflict, at least some of the time, with the physician’s traditional obligation to the individual patient. So, under the New Ethics, the doctor’s loyalty is now officially divided. DrRich asserts that this divided loyalty (which is now declared to be entirely ethical) leaves the patient in a dangerous position, and breaks the profession of medicine.

In the ACP’s response Mr. Doherty begins: “I asked Dr. Virginia Hood, chair of ACP’s Committee on Ethics, Professionalism, and Human Rights, to respond to Dr. Rich’s post. Her reply is below:”

Much ado?

We are surprised to see the comments about ACP and medical ethics. We urge readers to read the actual text of the ACP Ethics Manual (the College’s Code of Ethics) and the Professionalism Charter, which the College’s Foundation helped develop. Both say that social justice is a consideration in medical ethics, but the physician’s primary responsibility is to his or her patient. Resource allocation decisions are policy decisions and are most appropriately made at the system level, not at the bedside. The Ethics Manual discusses at length the clinician’s primary role as an advocate for individual patients. But it also notes the duty to practice effective health care and use resources responsibly, which are not incompatible with being a patient advocate. As the Manual notes, physicians should not overtest or otherwise overuse services:

Physicians have a responsibility to practice effective and efficient health care and to use health care resources responsibly. Parsimonious care that utilizes the most efficient means to effectively diagnose a condition and treat a patient respects the need to use resources wisely and to help ensure that resources are equitably available [i].

This is nothing new. Indeed using “effective and efficient health care and health care resources responsibly” for all patients is one way to minimize rationing as the result of an over costly system. The Manual also says that physicians and their professional societies should work toward ensuring access to health care for all and the elimination of discrimination, and deficiencies in availability and quality, in health care services. Likewise, the Charter on Medical Professionalism endorsed by ACP and 120 other medical organizations in the USA and internationally, states that professionalism involves commitments to improving quality of care, improving access to care, eliminating discrimination in health care, and yes, to a just distribution of finite resources. But the Charter explains the commitment to a fair distribution of finite resources as follows:

While meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited clinical resources. They should be committed to working with other physicians, hospitals, and payers to develop guidelines for cost-effective care. The physician’s professional responsibility for appropriate allocation of resources requires scrupulous avoidance of superfluous tests and procedures. The provision of unnecessary services not only exposes one’s patients to avoidable harm and expense but also diminishes the resources available for others [ii].

The patient-physician relationship and our medical ethics are the soul of medicine. The blog commentators are correct– it is important that we get it right.

Thank you.

Virginia Hood, MD, FACP
Chair, American College of Physicians Ethics, Professionalism and Human Rights Committee

As much as DrRich may feel he has been condescended to here (as if the ACP has found a fly buzzing around its head and has attempted to swat it away), and recognizing that the ACP has decided not to engage in a give-and-take (which, of course is their prerogative), but rather, has responded with a brush-off statement which they have chosen to bury in the comments section of DrRich’s obscure blog (which is also their prerogative), DrRich will attempt to reply as politely and as analytically as possible. (He does, however, sincerely hope that Mr. Doherty – who really seems like a good person and is an excellent writer – will not be called to the woodshed for obligating an august Ethics Committee Chairperson from this prestigious organization to issue a formal response to an annoying blogger such as himself.)

Dr. Hood’s artful (and dismissive, it seems to DrRich) statement can be fairly summarized thusly: After beginning with the implication that DrRich is making much ado (about nothing), and that she is surprised that anyone would dissent from ACP’s New Ethics, she says that the New Ethics does not entail the problem that DrRich alleges; indeed, there really is nothing new about it. Of course patients come first. (Just study the various documents the ACP has published on this point.) Cost-effective and efficient care is a part of good medicine, and always has been. What we mean by a fair distribution of finite resources is to practice medicine wisely, so as not to waste resources and not to expose patients to the risk of medical services they do not need. The legitimacy of the New Ethics is supported by the fact that it has been formally adopted by 120 medical organizations internationally (which to DrRich means that when you go to a doctor anywhere, this is the code of ethics under which they are now officially practicing).

There is a lot in her statement DrRich could comment on, but he does not want to bore his readers with a lengthy parsing of this finely crafted response. Rather, he will just talk about its main point.

Fundamentally, Dr. Hood is denying that there’s any problem. There’s no conflict between “the fair distribution of healthcare resources” and doing what’s best for individual patients – and furthermore, she’s surprised anyone would think so.

DrRich does not accuse her of sophistry. Perhaps she is just deceived.

The fact that there are huge conflicts between providing individuals with all the healthcare that would likely be useful to them, and the inability of society to pay for such a thing, is the fundamental problem with the public funding of healthcare. We simply can’t afford to buy everybody all the healthcare that would likely benefit them. There’s not enough money in the world to do that.

Consider just a few of the examples DrRich has discussed here over the years. Implantable defibrillators have been shown to significantly improve the survival of a substantial minority of patients who have heart disease, and indeed guidelines issued by cardiologists’ professional organizations indicate that defibrillators ought to be implanted at a rate of about five times their current actual implant rate. But if doctors actually did that, it would cost Medicare an extra $7 – $8 billion each year. Then there’s the fact that if doctors used the statin drug Crestor in the way the very well-designed and compelling JUPITER trial says doctors should use it, we would be spending an extra $10 billion per year on Crestor. In a thousand ways, the “best” healthcare for the individual is very often not cheaper (or better for society) than less-good healthcare, and DrRich is impressed that Dr. Hood is willing to say that it is.

Dr. Hood would likely deal with this problem, and implies so, by devising “guidelines” that doctors would be ethically obligated to follow. Obviously, it is entirely possible to convert “guidelines” from just that (i.e., a set of guidelines which doctors ought to take into strong account when deciding what’s best for their individual patients) into a set of formal rules that must be followed, and which will then be enforced by federal regulators (and their posse of ethicists). Indeed, such “guidelines” might be one of the ways in which society imposes its own goals over those of individual patients. But that is not the same thing as insisting that individual patients (who often do not fit the “average” profile) will necessarily profit if doctors always follow the guidelines as a matter of policy, or of enforced expectations, or of “quality”.

(Further, as DrRich has pointed out, the rapidly developing paradigm in which “guidelines” are becoming inviolate rules has led competing organizations to rush to issue their own sets of competing guidelines, that best comport with their individual agendas. While this phenomenon of “guideline wars” is endlessly amusing, it may not always serve the best interests of doctors or their patients.)

And then there’s the problem that, no matter how you define “waste” or “inefficiency” or “unnecessary care,” there simply cannot be enough of it to account for the runaway healthcare inflation we’re seeing (as DrRich has shown here). A substantial proportion of this fiscally disastrous healthcare inflation must necessarily derive from the delivery of healthcare that is actually useful.

So the crux of Dr. Hood’s reply – that all the ACP is talking about when it mandates that doctors fairly distribute limited resources is that they ought to practice good medicine, and if they did that simple thing no useful therapy would need to be withheld from any individual patient – is absurd on its face.

DrRich would be less disturbed by Dr. Hood’s assertion if he really thought it was simply a misapprehension of the truth. And perhaps it is. After all, her statement reads as if she is truly surprised that anyone would think otherwise.

Perhaps Dr. Hood came to her high station within the ACP’s Ethics Committee very recently, and is unaware of the history of the new Professionalism Charter which advanced this New Ethics, or of the controversy that was raised by many critics at the time of its adoption, or indeed, of some of the language that was in its penultimate version (and that was likely removed to silence some of those critics). Indeed, she cannot be aware if it, since she is “surprised to see” that anyone is bothered by the Charter, and since she believes that questioning it is but “much ado.” But to anyone who knows a little of that history, Dr. Hood’s assertion that controversy over this Charter is a novel experience, or most especially, her assertion that this New Ethics is really “nothing new,” would come as a very great surprise indeed.

First, we should note, if the new Professionalism Charter was really “nothing new,” and was just a restatement of the physician’s traditional obligation to place the patient first, and if fairly distributing society’s resources really was just a matter of practicing good medicine, then there would have been no need for a new Charter of medical ethics in the first place. And certainly the need would not have been pressing. It would have served quite nicely instead to produce some sort of document reminding doctors that unneeded healthcare services expose their patients to unneeded risk, so (based on the traditional ethical precept of patient welfare), to remain ethical they must stop being wasteful. Certainly, this kind of wasteful medicine would not produce a need to redefine medical ethics.

But the new Charter’s very first sentence describes something more dire, more pressing, than can be explained by Dr. Hood’s benign assertions. It says, “Physicians today are experiencing frustration as changes in the health care delivery systems in virtually all industrialized countries threaten the very nature and values of medical professionalism.” So: the whole purpose of this new Charter, its entire impetus, was the frustration of physicians.

Frustration? What frustration is that? Interestingly, the document does not come right out and say it. The closest it comes to spelling it out is to say, “We share the view that medicine’s commitment to the patient is being challenged by external forces of change within our societies.”

But even though the document seems strangely reticent about spelling out which frustration produced the very impetus for its creation, we can rely on the fact that the document must be designed to cure this mysterious frustration (whatever it is), and that the only revolutionary change in the document is an addition to the code of medical ethics requiring physicians to work for “the fair distribution of healthcare resources.” We can only conclude that this new ethical obligation is meant as a cure for that foundational frustration, and that therefore this frustration must be that doctors are finding it impossible to meet their traditional ethical obligation to to place their patients’ needs first.

But, as it happens, we do not really have to resort to this sort of documentary detective work to parse out the purpose of the new Professionalism Charter. That purpose was quite open at the time this document was being developed – and it produced robust controversy that was certainly no secret. One can read about this controversy in many places, but for our purposes now (i.e., in replying to Dr. Hood’s assertion that there’s nothing new here, and that it is a matter of some astonishment that anyone would find the Physicians Charter controversial) it might be best to refer to one of the ACP’s own publications from that time.

An article in the July, 2001 ACP-ASIM Observer, which was entitled, “Charter on medical professionalism addresses issues of finite resources,” goes into some length about the controversy. And it is very plain that the objection many raised to the new Charter was precisely that which DrRich is raising now in his challenge to the ACP: that the New Ethics being espoused in the Professionalism Charter fundamentally and explicitly divides the loyalty of the physician between the patient’s needs and society’s needs. When one listens to the defenders of the new Charter (quoted extensively in the ACP-ASIM Observer article), one finds the unmistakable tones of utilitarianism: We have to change our ethical precepts, the argument goes, because that’s just the way the world works now.

This article also indicates that the draft of the Physicians Charter presented to ACP general membership at their annual meeting in 2001, a few months before the final version was finally published, was perhaps more forthcoming than the final version, regarding what it was really all about. For instance, this nearly-final version of the Charter specifically admonished physicians that they must “be aware that the decisions they make about individual patients have an impact on the resources available to others.” One can only assume that this sort of explicit language was taken out of that final version in response to the critics (who were many, and vocal) to soften the blow.

Indeed, the “softer” language of this strange final version (which has all the hallmarks of a heavily edited document, beginning as it does with a heartfelt cry against the frustrations being experienced by physicians, then neglecting to spell out what those frustrations are, and never explicitly saying which aspect of the document addresses those frustrations), is now possibly soft enough, if not read carefully, to allow defenders of the Professionalism Charter to get away with asserting (as Dr. Hood has done) that the New Ethics is really pretty much the same as the old ethics, and does not change anything. (So move along, move along.)

But the New Ethics changes everything.

DrRich is very sorry about this, and is especially sorry that the ACP’s Ethics Committee, and the other 120 physicians organizations that have adopted this New Ethics, insist they do not see a problem here. DrRich assumes by this response that the ACP has little interest in revisiting its new ethical stance, and further, is undoubtedly busily training today’s medical students that doing what’s best for society is the same as doing what’s best for the individual.

This is a theme, DrRich thinks, he’s heard a lot lately.

Patients who want a true advocate in their life-and-death encounters with the healthcare system, an advocate whose loyalty is not divided between them and a society that, with increasing desperation, wants not to spend its money on them, had better go out and hire their own. Your doctor will now find it officially unethical to serve that office him-or-herself.

And meanwhile, we can now be sure that the physicians organizations which are responsible for protecting the ethical foundation of the profession of medicine are quite satisfied with the job they are doing.