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 Global Warming and the Importance of Bias in Scientific Progress [14:59m]: Play Now | Play in Popup | Download (75)

DrRich is relieved to learn that the world’s most famous global warming experts have now been exonerated by three separate formal reviews. Dr. Michael Mann from Penn State University was cleared by a review conducted by Penn State University. Dr. Phil Jones, Director of the University of East Anglia’s Climate Research Unit (CRU), was cleared by a review conducted by the University of East Anglia, and also by a four-member “independent panel,” one of whose members was Prof. Geoffrey Boulton, a personage who had been on the faculty of East Anglia’s School of Environmental Sciences for 18 years, and who (prior to being placed on the “independent panel”) had been a vocal defender of Dr. Jones’ actions regarding Climategate.

Right-wing global-warming-deniers, of course, have decried the results of these reviews as a “whitewash,” pointing out, among other things, that Penn State and East Anglia both continue to receive tens of millions of dollars in federal “research” funds so they can continue to prove that global warming a) exists, and b) is man-made, thus suggesting that these institutions were determined to acquit their star grantsmen of scientific misconduct no matter what the objective findings. This kind of whitewash, they say, not only supports the global warming “hoax,” but even worse, further undermines the integrity of the scientific process upon which so much of modern society so utterly relies.

Of course, if right-wingers are correct, then reversing modern society and putting us all back in the glorious horse-and-buggy days is the very goal of the global warming mavens. (DrRich, a student of history, is well aware of how difficult it must have been 110 years ago to walk the streets of New York City without ending up splattered with dung to your knees, and he wonders what life would be like today, navigating the highways and byways of America, if all 300 million of us were relegated again to modes of transportation that defecate nearly continuously.)

It must be admitted, by anyone who has perused some of the leaked e-mails sent and received by Dr. Jones (making it doubtful that any of the three review panels had actually done so), that from any really objective viewpoint the global warming experts had engaged in some very questionable behaviors, which appear to have been aimed at advancing their theories, and suppressing any opposition, by any means at their disposal. The e-mails depict Jones and prominent colleagues discussing how to “tweak” climate change data in order to hide such embarrassing climatic phenomena as the Medieval warming period, “the little ice age” that followed it, and the global cooling we’ve been seeing over the past decade. Including these historical temperature fluctuations in their data would make their famous hockey stick graph look less like a hockey stick, and more like the random profile of a mountain range. (And once Al Gore won an Oscar for showing slides of the hockey stick, that was not an option.) They also collaborated to “control” the peer-review process so that only the “right” peers would be doing the reviewing, and the “wrong” peers would be cut off altogether. And, as a final deft touch, they all shared electronic high-fives when a noted global warming skeptic died unexpectedly.

Then, of course, just a few days after the embarrassing e-mail leak, the CRU was forced to admit (thanks to Britain’s Freedom of Information act) that they had, apparently intentionally, destroyed all the raw temperature data upon which their elaborate computer models were based. (They say they ran out of space to store it, apparently failing to recall the many forms of magnetic storage readily available to scientists today). The destruction of this data utterly precludes other scientists from checking, and attempting to reproduce, the critical predictive model upon which the theory of man-made global warming largely rests.

Oops.

This inconvenient truth renders their climate change model a black box. It places the rest of us in the position of having to “just trust” the global warming experts, upon whose work (for instance) President Obama bases his proposal for a fundamental change in our economy, our way of life, and our foundational political philosophy.

So it is perhaps somewhat understandable that right-wingers object so vociferously to the alleged “whitewash.” Their general complaint seems to be that the scientific process should always be pristinely unbiased, and that the gross bias so clearly displayed by global warming experts in this case not only corrupts the case for global warming, but also corrupts the scientific process itself, to the extent that every scientist in the world should be screaming for the heads of the miscreants, and indeed, must do so, to salvage the very legitimacy of science.

DrRich is sympathetic to the argument that the implications of Climategate are troublesome, but not because the climatologists have behaved in a terribly biased way. Biased thinking within a scientific debate is not only common practice, but also it is a critically important part of the process. Raw contention between very biased scientists with very different viewpoints is how we get scientific progress in the first place. DrRich is not even disturbed that the currently-entrenched global warming experts have used their position of relative strength to suppress the upstarts who dared to oppose them. That’s also pretty much standard behavior in the academy, and it, too, serves a useful purpose.

Rather, what’s troublesome about the global warming controversy is that outside authorities of incredible power have taken an extraordinarily strong position in the scientific debate, and have lent their massive influence to one particular side. Whenever this sort of thing happens, the “winner” of the scientific contest is often not determined by superior scientific merit, but by other factors.

Scientific progress works like this: A new theory is conceptualized to explain some phenomenon, usually by a whippersnapper of one variety or another. The entrenched experts, whose careers, reputations, social status, incomes, and sexual fulfillment are based on the old conception, find the new theory to be absurdly wrong (or in some cases heretical), and probably dangerous. Since preserving the “truth” is the highest calling of all, the experts engage in every device they can muster (from “controlling” the peer-review process to burning heretics at the stake) to see that the truth (as they define it) prevails.

To the uninitiated – and certainly to the upstart whippersnappers – this process seems primitive and unkind. But actually it is quite useful and practical, and in the long term is very beneficial to mankind. For most of the new theories thought up by whippersnappers are, in fact, garbage. In order to break through the imposing barriers of bias constructed by the entrenched experts, the novices really have to believe in what they are espousing, and their new theory, ultimately, has to actually offer some substantial improvement over the currently accepted one. The whippersnapper, if very lucky, finally becomes the foundation of a new generation of experts – and the process begins all over again. Hence, science progresses. The process is geared toward the gradual discovery of truth, and not toward the nurturing and vindication of whippersnappers. And eventually, truth always does prevail – and often it does so within just a few generations.

In the short term, of course, this process can look very messy and unfair. It is certainly subject to great bias. In fact, we take pains to set up the accepted experts with lots of grant money, prestige, titles, &c. precisely to make sure they’ll do everything they can to preserve the status quo. We do this so that when the paradigm actually shifts, it shifts because the merits of the new paradigm are sufficient to overcome all the bias – and not because of a whim. This process keeps science – and society – from being whipsawed this way and that.

Where the process breaks down is when a powerful outside influence – say, a religion or a government – firmly takes a side in the scientific debate. For example, just ask any of the would-be astronomers from the time of the pre-Renaissance Popes how well the scientific process of competing biases worked out for them.

It seems apparent, to DrRich at least, that  most of the world’s governments, including ours, find that the bias of the global warming experts very nicely aligns with the historical bias of governments, which is to say, accruing ever more power over the endeavors of the people.  It may possibly be for this reason that governments have thrown in – body and soul – with this side of the debate, to the extent that “global warming” has now become largely sacrosanct. Man-made global warming is officially deemed (like the 2011 U.S. Budget) to be  “settled science,” and is beyond reasonable question. No new scientific evidence to the contrary is admissible. Competing viewpoints are, in fact, heretical. And even when gross evidence of academic misbehavior on the part of global warming experts is revealed, that evidence is excused, paved over and ignored.

This mindset is the only one that fully explains the tone and the content of the Climategate e-mails, and the subsequent exoneration of the climate scientists who wrote them.

Most readers, DrRich expects, agree with him to this point. (For, how could it be otherwise?)  But, you may be asking, what does any of this have to do with healthcare, or more specifically, with healthcare rationing?

As we enter into a new era of healthcare, where medical decisions will be taken out of the hands of imperfect physicians and entrusted to panels of federally-sanctioned (and thus pretty much infallible) experts, who will analyze the available data and construct the guidelines of behavior by which all physicians will henceforth be judged, we ought to keep the problem of unbalanced bias in mind.

Today we have a healthcare system in which competing interests, and their competing biases, battle for prominence. The process is messy, ugly and often unfair, but with long-term results that are generally reasonably favorable. Or at least, the damage is generally contained.  But we are headed toward a healthcare system in which only one great interest – that of our government, with its overwhelming bias toward cutting the cost of healthcare – will predominate.

A great fallacy under which many of us labor is that the government has no strong biases, and that a process overseen by the government will be inherently far more “fair” than a process that incorporates the biases of for-profit enterprises. But in truth, the government is the biggest, meanest, special interest of all. And like all sovereign authorities, this one is not only able to, but is expected to get the results it deems necessary by the measured application of violence.

For those who believe any government, anywhere, which has total control over any human enterprise can still behave fairly, DrRich begs you to please have another look at history. When we allow government (and its agents) to have the only say over medical decisions, then those medical decisions will be made with all the robust, open-minded, free, give-and-take exchange of ideas we are seeing from the global warming experts today. And while medical progress – like progress in general – cannot be forever halted, it will become as sclerotic as the scientific progress enjoyed by those pre-Renaissance astronomers.

The scientific process will always be biased. Where we invite serious damage is where we admit only one form of bias, and forcibly stifle all the rest. It’s bad for climate science, and it will be bad for healthcare.
________________________________

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

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 More Arguments for Withholding Crestor [21:30m]: Play Now | Play in Popup | Download (93)

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

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 Neuroscientists Beware! Here Come the Cardiologists! [17:31m]: Play Now | Play in Popup | Download (108)

Throughout the millennia, the characteristic that has distinguished robust barbarians from extinct ones is that, when forces beyond their control begin encroaching on their turf, they simply pick up and encroach on the turf of less aggressive people (generally, of people who are more advanced, both intellectually and culturally, than they are).

And so, when the Feds begin making noises about limiting some of cardiology’s favorite revenue-generating activities, the cardiologists – among the most robust of the medical barbarians – are quick to overrun the turf of other, less bloodthirsty and more civilized, medical specialists.

DrRich in the past has attempted to warn his medical colleagues about the predatory nature of cardiologists. He has told how the cardiologists have driven the formerly proud and powerful cardiothoracic surgeons into a sad state of underemployment, how they have usurped the formerly sovereign territory of diabetes specialists, and how they are currently laying siege to sleep medicine and bariatrics.

And now, continuing his public service to the less robust medical specialists (whose great achievements, like all cardiologists, DrRich admires), he must reluctantly extend his words of warning to his friends, the neuroscientists.

Cardiologists began encroaching on the field of neurology many years ago, but only surreptitiously, when they took to blaming imbalances of the autonomic nervous system (i.e., dysautonomia) on mitral valve prolapse. In more recent years, somewhat more blatantly, they have attempted to take ownership of migraine headaches. And now, just last week, in a full frontal assault, cardiologists laid claim to Alzheimer’s Disease.

Neuroscientists, nobody is safe! Hide your women and children!

The pattern of behavior employed by the invaders is easy enough to spot. First, cardiologists call attention to an alleged association between some cardiac condition (a condition they will manufacture if necessary), and a non-cardiac medical problem. Then, immediately, they will assert that (or at least begin behaving as if) the association proves a cause-and-effect relationship. Finally, since they have “proven” that the non-cardiac medical problem is caused by a cardiac condition, patients who have (or might develop) that non-cardiac medical problem need to be referred to cardiologists, who, lo and behold, have invented a well-paying procedure to treat it, or at least, to study it further.

The best known example is mitral valve prolapse (MVP), a congenital condition in which the mitral valve partially flops open when it should be closed, thus allowing blood to flow backwards (i.e., to regurgitate) across the mitral valve as the heart contracts. (For anyone interested, here’s a brief description of the heart’s chambers and valves.) Now, significant MVP can be a serious medical problem, and it often requires mitral valve surgery. Fortunately, however, significant MVP is a relatively uncommon condition.

The problem is that echocardiography (a non-invasive test using sound waves to create an image of the beating heart) has become so advanced that some degree of trivial MVP, it seems, can be found in almost anybody. According to some studies, as many as 25 – 35% of healthy individuals – people without any cardiac problems or any symptoms whatsoever – can be said to have some degree of MVP. In fact, whether you have MVP or not depends largely on what criteria the echocardiographer uses to make the call, and how badly the doctor wants you to have the diagnosis.

Over the years it has become customary to diagnose MVP in young, apparently normal people who have the temerity to complain about the highly disruptive symptoms of dysautonomia (such as fatigue, weakness, strange pains, dizziness, constipation, diarrhea, cramps or passing out), without supplying the kinds of objective physical or laboratory findings which, doctors insist, patients are always obligated to provide. Such thoughtless patients are now routinely sent for echocardiography, so that MVP can be diagnosed (since it can be diagnosed just about whenever it is looked for). The patient is then given the diagnosis of “mitral prolapse syndrome,” even though: a) the MVP is usually so trivial as to be nonexistent; b) the studies which claim to show an association between MVP and these sorts of symptoms are generally based on a gross over-diagnosis of MVP; and c) there is no credible theory based on actual physiology to explain how MVP – even real MVP, much less the trivial kind – might cause such symptoms.

But no matter. “Rule out MVP” has become one of the most common reasons for young, healthy people to be referred for echocardiography, and has become a staple source of income for cardiologists.

The story is similar for the association between patent foramen ovale (PFO) and migraine headaches. In the developing fetus, the foramen ovale is a hole that is present in the atrial septum (the thin structure that separates the right atrium from the left atrium). At birth, a flap of tissue imposes itself over the foramen ovale, causing it to close. In some people, however – people with PFO – the tissue flap is still capable of flopping open. In people with PFO, the foramen ovale can open transiently if the pressure in the right atrium becomes transiently greater than the pressure in the left atrium, such as with coughing, or straining during a bowel movement.

In rare instances, strokes in healthy young patients have been attributed to PFO. The supporting theory is that a stroke can occur when a blood clot happens to be coursing through the right atrium at the precise moment a person with PFO is coughing (for instance), allowing the clot to move into the left atrium, and on to the brain. And because this theory is at least plausible, in a young person who has an unexplained stroke and is then found to have a PFO, it makes at least some sense to close the PFO.

But the presence or absence of a PFO is a little like the presence or absence of MVP. Its diagnosis depends on how hard the echocardiographer looks for it, and on how much the doctor would appreciate the diagnosis. With modern echocardiographic equipment, at least some sign of PFO can be found in as many as 25% of normal individuals.

Being able to make this nifty diagnosis is of little use to cardiologists if the only clinical problem it may cause is a one-in-a-million chance of stroke. One cannot make a living, or even make a car payment, doing echocardiograms in young patients with cryptic strokes. They’re just too darned rare. So it didn’t take long for cardiologists to draw a more useful association – this time, between PFOs and migraine headaches.

While all the things that have to happen in order for a PFO to cause a stroke are very unlikely, it is at least possible that they could all occur simultaneously in a patient. This is not the case with migraine. No plausible theory has been advanced to explain how PFO might cause migraines. The only reason PFO is being invoked as a cause for migraine is that when patients with migraine have been carefully studied for the presence of PFO, an increased incidence of PFO was found. But (as we have seen) when PFO is carefully sought in any population of patients, it is more likely to be found. The only likely reason PFO has not been associated with cancer, red hair, type A personality, or difficulty in memorizing the multiplication tables is that cardiologists have not thought of looking for it (yet) in these conditions.

For cardiologists, the poorly-supported allegation that PFO causes migraine is particularly compelling, since not only can they get paid to look for PFOs in migraine sufferers, but also there is an invasive (and lucrative) procedure they can do to close PFOs, to “treat” the migraines. Studies to date have not been successful in showing that closing PFOs improves migraine headaches, but that hasn’t kept cardiologists from screening migraine patients for PFO, then offering them PFO closure as a therapeutic option.  This, again, is because an association implies cause and effect, at least when that implication can be helpful to someone.

Migraine sufferers are particularly vulnerable to this and many other unproven therapies, since they are often disabled by their condition, and in many cases medical science (or medical ignorance) offers them insufficient help. Consequently, anecdotal stories abound regarding unorthodox therapies that cure migraines. DrRich, himself a migraine sufferer for many decades, has heard all the stories. (He even has one of his own. If DrRich maintains a schedule of running at least 20 – 25 miles a week, he does not get migraines. If he quits running for a few weeks the headaches come roaring back. He has mentioned this decades-long and reproducible pattern to several neurologists and other specialists over the years. They conclude that DrRich – and this should not be a surprise to many of his readers – is nuts. But if cardiologists had a billable procedure that could make you exercise, you can bet they’d fold DrRich’s experience into their formal clinical guidelines.) In any case, merely performing PFO closures on a few migraine suffers was almost guaranteed to produce a patient here or there who would report a positive response. And despite the continued negativity of actual clinical trials so far, that’s what happened.

So, at least by anecdote if not by controlled trial, closing PFOs can cure migraines.

But now it gets even worse for the neuroscientists. Any neurologists who ignored the cardiologist’s usurpation of dysautonomia, and who may have felt only a little more concern when cardiologists began to lay claim to migraine headaches, had best sit up and take notice. Because now, cardiologists have a way of treating (at least preventing, if not actually curing) Alzheimer’s Disease.

This time it is DrRich’s own particular sub-branch of the cardiology tribe which is the culprit – the electrophysiologists.  In a way, it is a little disappointing for DrRich to see his EP brethren going in for the same, turf-grabbing sophistry used by lesser cardiologists. EPs are known for being more intellectually sophisticated than your typical heart doctor (who, after all, is a glorified plumber). Indeed (as he thinks he may have mentioned in the past), DrRich has a neurosurgeon friend who, when he wants to convey the idea that what he is doing isn’t quite as difficult as it appears, but at the same time what he is doing is, in fact, neurosurgery, will say, “It’s not exactly electrophysiology!” But of course, he may not say this anymore once he finds out what we EPs are up to.

Last week, at the Heart Rhythm Society Scientific Sessions, researchers presented a study suggesting that ablation procedures for atrial fibrillation are associated with a lower risk of Alzheimer’s disease. (Here’s some information on atrial fibrillation and its treatment for anyone who is interested.) The study was presented as an abstract only, so we know relatively little about the specifics.

But, really. Atrial fibrillation and Alzheimer’s are both disorders associated with aging, so it is not surprising that they are associated with each other – in the same way that atrial fibrillation is associated with gray hair, cataracts, and bunions. Ablation for atrial fibrillation is a relatively lengthy and difficult procedure, whose results are relatively middling, and which carries a substantial risk of some really nasty complications. So these ablation procedures are generally reserved for carefully selected, reasonably ideal candidates – usually, the relatively young, relatively healthy atrial fibrillation patients, who are less likely to get Alzheimer’s disease over the next few years whether they have ablations or not.

So there is a lot to be cautious about in interpreting a preliminary study like this one. For a well-presented, comprehensive treatment of why the results of this study should be largely ignored for now, see Dr. John M’s blog. (It sounds like John M is as embarrassed by his fellow EPs in this instance as is DrRich).

But such objections as DrRich and John M may express are just quibbles. The headlines are already blaring: “Ablation Procedures For Atrial Fibrillation Prevents Alzheimer’s.” Whatever the details and limitations of this study, cardiologists can now treat Alzheimer’s. Mission accomplished.

Having duly (and humanely) called this problem to the attention of his neuroscience friends, DrRich would like to finish by emphasizing a larger point.

You can’t fight the Feds. When the sovereign authority, at the point of a gun, decides to reach down into the world of the medical specialists, and dictate which medical services are no longer going to be feasible (all for the noblest of purposes, of course – to maximize quality and efficiency and the collective good), the affected medical specialists have a limited range of possible responses. And fighting the Feds is NOT among these available responses.  Better to fight the change of seasons.

So the affected specialists can contract their horizons, take what’s left, and try to make the best of it. Or, they can do what the Visigoths did when the people of the steppes displaced them. Strike out against other, weaker specialists, and take what’s theirs. If you can’t grow the pie anymore, then take the other guy’s piece.

DrRich is not passing any judgment on his cardiology brethren here. He is just describing what’s happening, as a public service. You neuro-types, he believes, have a right to be told what’s happening. You can do with the information as you see fit.

In the meantime, DrRich remains supremely confident that his cardiology colleagues can find a nearly unlimited supply of plunder in this brave new world. They are very robust barbarians.

DrRich is not smart enough to predict what specific bribes, threats or subversive parliamentary maneuvering will finally win passage of the President’s healthcare reform. However it comes about, DrRich thinks the result will be bad.

DrRich arrived at this opinion through a long process, lasting many years, that changed his thinking on the proper role of our government in our daily lives. One key event within this long process, which he related in his book, first opened DrRich’s eyes regarding the essential benignity of our government as it administers its assumed role as guardian of the people’s healthcare.

DrRich reproduces this vignette here:

One afternoon in June of 1994, I was summoned to a meeting by a vice president of the hospital for which I worked at the time. Meetings, especially unannounced ones, are the bane of employed physicians; but this one, I was led to understand, was mandatory.

I found the meeting room filled with high-ranking hospital administrators, hospital attorneys, and my clinical chairman. A gathering of luminaries such as these, especially on short notice, was decidedly rare. As I walked into the room all eyes were on me. I knew all these people; they’d been my friends and colleagues for years. We’d been fighting the healthcare wars side by side. But now they studied me as if seeing me for the first time.

“Who died?” I asked, just to break the ice.

“To be determined,” responded one of the lawyers.

They got right down to business. The chief hospital attorney explained: The federal government, in the guise of the Office of the Inspector General (OIG), had launched a major investigation of allegedly improper Medicare billing practices related to the use of investigational implantable cardioverter defibrillators (ICDs) in the late 1980s. This investigation, I was told, had begun as a whistleblower law suit out on the west coast, and the feds were now expanding their inquiry. The OIG had just subpoenaed records from approximately 120 of the largest hospitals in the country that implanted ICDs. We were one of the 120.

Now I understood why I was here. As Chief of Cardiac Electrophysiology, research with the ICD was one of the major endeavors of my career. The ICD is a device that is designed to prevent sudden death in patients whose cardiac disease makes them susceptible to such an event. Once implanted, the ICD recognizes the sudden, lethal heart rhythm disturbances that cause nearly instant death, and automatically delivers a shock to the heart to restore it to a normal rhythm. It is a remarkably effective device, and was obviously so from the very beginning. Seldom, in fact, has a more dramatically effective life-saving therapy ever been devised for any illness or disease. For this reason, as long as I had access to these devices I (and most electrophysiologists), felt morally obligated to offer them to any eligible patients who were at high risk for sudden death.

So now I understood why I had been summoned to the meeting. What I didn’t understand was why the Feds thought we’d done anything wrong.

“We shouldn’t have any problems there,” I protested. “You’ll recall that we looked into the legality of billing for ICDs back in ’87 when I first started working here. And Medicare said it was okay.” While I was an employed physician (and so the hospital handled all the billing for my services), I’d had enough concern about billing Medicare for investigational devices that I’d insisted the hospital get clarification from our Medicare Intermediary (the local agent and representative for Medicare) on the matter.

One of the attorneys answered. “That’s right. The Medicare Intermediary indicated at the time that there was nothing illegal about billing for the ICDs, but couldn’t guarantee they’d pay for them. As it turns out, they’ve paid for each one we’ve implanted, and never questioned our using them.”

“Then what’s the problem?”

“Medicare now says we’ve been in violation by sending the bills,” the lawyer replied. “There’s apparently an obscure instruction in the Intermediary’s guidebook that prohibits billing for some investigational devices.”

“But we got clearance from the Intermediary,” I protested.

“And that’s the defense we’ll take. The Intermediary itself didn’t know about this instruction. But unfortunately, Medicare operates a little like the IRS. If you call the IRS with a tax question and they give you bad advice, it’s your fault if you follow that advice. The fact that the Medicare people were unaware of their own rules, and apparently told us the wrong thing, doesn’t absolve us.”

“So what’s the worst case scenario?” someone asked. “That we’ll have to pay all the money back?”

“The monetary penalties are much worse than that,” intoned the CFO. “We’re looking at over 100 investigational ICDs that the good doctor here has implanted,” he said, glaring at me. “And at about $25,000 each, that’s a pretty penny right there. But the Feds are also talking about a $10,000 fine per incident, plus triple damages, so we’re really looking at several tens of millions of dollars we can’t afford. What’s worse, the fact that the OIG joined the whistleblower’s actions suggests that they’re going to claim we intentionally violated Medicare regs – which could mean jail time.” He was looking at me again when he said “jail.”

“Don’t worry,” a vice-president said to me sympathetically. “We’re all in this together. We’ll help you as much as we can.”

“What do you mean, you’ll help me?” I shot back. “I just work here. You do all the billing, keep everything you collect, and pay me a paltry salary.”

“Like I said, we’re all in this together. But those bills do go out under your name, Dr. Fogoros. As far as Medicare is concerned, they’re your bills.” As I’ve since learned, when the feds begin pointing their fickle finger, it’s customary for everybody to dive for cover.

For the next two years my life was plagued by a series of complex machinations – legal probes and parries – made in response to the Feds’ investigation of our supposed “fraudulent” submission of bills. I won’t bore you with the details – I’ll just hit a few highlights.

First, my hospital threw in with two dozen other large hospitals from all over the U.S. that were also affected by the OIG’s subpoena, and together we hired a fancy inside-the-beltway law firm that specialized in healthcare law. These attorneys ultimately determined that the obscure regulation the OIG was invoking against us had itself been illegally promulgated, and therefore should not be enforceable. Accordingly, our hospitals sued Donna Shalala, Secretary of Health and Human Services (HHS) in federal court to prevent her from enforcing this obscure, previously unknown, and (we held) illegal rule. “We have maybe a 50-50 chance of winning this suit,” I was told by one of our attorneys, “but it won’t be settled for years.”

While all this was going on, the subpoenaed hospitals also lobbied Congress to act on the essential unfairness of it all. “Look,” the hospitals said, “we’ve got one agency of the federal government (Medicare) coming after us for doing research that had been duly approved by another agency of the federal government, the Food and Drug Administration (FDA). We need laws to make the Feds behave consistently. When the FDA approves clinical research, Medicare should allow patients to avail themselves of that approved research.” Finally, in November of 1995, Congress passed just such a law. “So we’ve won!” I exulted when the hospital attorney called me with the good news. “Not exactly,” was the reply, “The OIG prevailed on Congress not to make the law retroactive. So the OIG is still coming after us for what they say we did in the 1980s.”

Then, in January of 1996, the Feds launched a new attack. Senator Roth, Chair of the Senate Finance Committee, decided it would be in somebody’s best interest to have a showcase hearing, highlighting the grievous crimes against Medicare that are being promulgated by avaricious physicians and institutions like me and mine. So the Permanent Subcommittee on Investigations sent subpoenas to the CEOs of several hospitals from the OIG’s list of 120, mandating that they appear before that committee on Valentines Day (i.e., heart day) to answer questions regarding the allegations that we’d committed Medicare fraud in our use of the ICD. It was to be a real circus – it was to be covered on C-SPAN, with major networks in attendance and lots of national publicity. The works.

Immediately, there was a mad rush to have the subpoenas quashed. All the hospitals from states whose Senators were members of the Finance Committee managed to be excused from appearing. At the end of the day, only four hospitals remained. Mine was one.

I was sure my career had ended. My family, friends, patients and colleagues were about to see the CEO of my hospital appearing before a hostile Senate Investigational Committee answering questions on the Medicare fraud that I supposedly had committed. I knew it didn’t matter that I hadn’t done anything wrong. Truth is only a compilation of some facts, whereas perception is everything.

I spent two days in Washington helping the fancy beltway lawyers prepare our CEO for his testimony. I failed miserably in my emotional pitch to be allowed to testify in his stead (the CEO had been subpoenaed, not me; and besides, anyone who seemed eager to testify before Congress must be crazy enough to get us in trouble). But at least I managed to convince the CEO that we should take a hard line with the subcommittee. After all, we had truth, righteousness, ethics, and possibly even the law on our side. We shouldn’t allow ourselves to be intimidated.

Each witness was to be permitted to read a statement into the record before the questioning began. Our attorneys had prepared a 10-page statement that was vague, wishy-washy, filled with legalese, and as nearly as I could tell, didn’t deny wrongdoing as much as it promised we’d be more careful next time.

So I prevailed on the CEO to tear up this lawyered-up document and instead use a one page statement that I wrote for him, saying, in essence: 1) We implanted investigational ICDs in Medicare patients because they were at high risk of dying without them, and to withhold such life-saving devices when they were available to us would have been unethical and would have constituted malpractice. 2) Before implanting the investigational ICDs, approval for their use was obtained through the FDA. 3) Before billing for the investigational ICDs we asked for and received clearance to do so from our Medicare Intermediary. 4) The records and documents we sent Medicare in support of our billing for these ICDs clearly indicated that the devices were investigational, and yet Medicare reimbursed us each time, over a period of several years and without questioning our actions or our bills. 5) The rule Medicare is now invoking was unknown to us during this period of time, and also, apparently, was unknown to the Medicare Intermediary. 6) In any case, as we have asserted in federal court, that regulation was illegally promulgated, and is therefore not a legal rule. 7) Congress has agreed that regulation to have been at least an ill-advised one, as evidenced by the fact that Congress recently passed legislation that now renders that regulation illegal, whatever its previous legality. 8] If they now assert that our actions constitute fraud, then the message the OIG, Medicare and the Senate subcommittee is sending to the public is that doctors and hospitals are expected to discriminate against the elderly, and will be called to task by the federal government if they refuse to do so. 9) Thank you for your attention.

The hearing was indeed quite a show. The whistleblower himself was the first witness, and he entered the chamber wearing a hood to hide his face, sat behind a screen, and spoke with his voice electronically distorted. This was the first time in history, I was told, that a witness had appeared before Congress disguised in this way, except in hearings featuring Mafia turncoats, drug lords, and the like. The implication, I presume, was that I and my fellow cardiac electrophysiologists were no less evil or potentially violent than other, more famous sorts of felons; and that if we learned this guy’s identity his life wouldn’t be worth a nickel.

Then it was us perpetrators’ turn to testify. The CEOs of the other three subpoenaed hospitals, after reading their lengthy, lawyerly and seemingly contrite statements into the record, were grilled mercilessly by the Senators of the subcommittee. Our CEO was the last witness. Once he read our brief but much more aggressive statement, the Senators seemed not to have any substantial questions for him. His testimony was over almost before it had started. Our hard line had paid off.

One more blessing occurred on that day. Somebody apparently found some Whitewater documents that weren’t supposed to have existed, so ten minutes before the hearing, C-SPAN pulled out and went running down the hall to televise the Whitewater doings. All the other news media went with them. Our hearing, despite the big build-up, the dramatically disguised whistleblower, and the fact that it was Valentine’s Day, barely made the news. The lack of national news exposure (and as a result, the lack of local news coverage) spared my reputation and that of my hospital.

Then finally, later in 1996, a federal judge ruled in our favor in our suit against HHS – the regulation Medicare was invoking, the judge ruled, had indeed been illegally promulgated. The OIG still didn’t give up, but in the end offered a settlement deal to the hospital for a mere million or two (which, by this time, was less than we had already spent defending ourselves), and nobody would have to admit to wrongdoing or go to jail or have a criminal record.

DrRich is not complaining. This episode could have turned out a lot worse. And the whole ordeal provided him with enough amusing anecdotes to last a lifetime. But having the Feds coming after him for more than two years was truly an eye-opening experience.

As DrRich sees it, the rightness of his actions seemed completely obvious. He had used those ICDs because his high-risk patients needed them, and from every indication their usage was legal and proper. But, in the service of his patients he had failed to discover a vague, obscure and difficult-to-interpret rule that existed in the Medicare Intermediary’s guidebook (a guidebook to which he had no access). As a result DrRich had been caught up in the Fed’s great anti-fraud initiative.

For over two years DrRich could never be sure of what was going to happen to him. There were periods of days at a time, usually just after another round of legal punches and counter-punches, when there was little else he could think of. (Would he lose his job, his career, his reputation, all his worldly possessions – would he go to jail?) During those times DrRich was of little use to anybody – colleagues, family or patients.

Of course, in the end it all turned out just fine – but the reason for the favorable outcome wasn’t that the Feds finally agreed that DrRich’s actions had been appropriate and non-fraudulent. It was because his lawyers had found a legal technicality in the Fed’s own actions. Had it not been for this entirely fortuitous discovery, who knows what might have happened?

So DrRich has seen a side of the Feds that most doctors have not, and he is willing to admit to a more robust paranoia on the subject than most would have at this moment. The way it looks from here, the government – at least sometimes – is willing to go to great lengths to prove just how rife with fraud is our healthcare system, and, once the Feds set their sights on an alleged perpetrator, they are pleased go to equally great lengths to bring that supposed perpetrator down. At least sometimes they’re willing to base their prosecution on bad rules that are poorly written, illegally promulgated, and hidden away in obscure manuals; they’re willing to ignore the fact that the alleged perp had relied on advice from the Feds’ own agents before proceeding; they’re willing to summon that perp before a televised, circus-like inquisition to be publicly humiliated for actions that, just a few months earlier, they themselves had passed explicit laws to endorse; and they’re willing, when all legal justifications for their persecutions have at last been taken away, to make a final demand, that some might consider extortionate, for a cash payment before they’ll go away.

At least, that’s how it looks from here.

It is not DrRich’s position that the Feds have been engaging in an unmitigated orgy of illegitimate anti-fraud activities over the past dozen years or more. He is sure they have not. Indeed, most of the anti-fraud activities the Feds have undertaken have undoubtedly been legitimate and useful. Furthermore, DrRich fully understands that any get-tough government initiative – whether it be anti-fraud or anti-terror – has got to have teeth, and that it is natural if regrettable that occasionally, a few innocents will be ensnared in such efforts. DrRich admits the possibility that his frightening experience may represent nothing more than the collateral damage that will naturally happen whenever the sovereign power finds it necessary to wield its great hammer in the overriding interest of the public good.

But forgive DrRich if he believes it is more likely that the experience he has just related represents instead an early glimpse into the government’s methods of intimidating and controlling doctors who, without these kinds of necessary checks, will, in caring for their patients, simply keep doing whatever they’d like with the government’s money. DrRich happens to believe that the utter unpredictability, arbitrariness, doggedness and seeming absurdity of the government’s actions in his own case was not accidental. These techniques are essential to the Feds’ goal of keeping their prey (i.e., physicians) intimidated, completely off balance, and in their thrall.

As evil as we all know the health insurance industry to be, DrRich (and any physician who knows anything about it) would much rather attempt to appeal to/defy/maneuver against/manipulate private insurers for the benefit of their patients (since the worst these entities can do is withhold payment), than do anything whatever – either for the patient’s benefit or for any other reason – that would risk engendering the enmity of the great, slavering, merciless sovereign authority.

Just a thought, as we embark on our new government-controlled healthcare system.

Regular readers will know that Dr. Virginia Hood, Chair of the American College of Physician’s Center for Ethics, Professionalism and Human Rights, has responded on behalf of the ACP to DrRich’s challenge to debate the New Ethics being promulgated by the ACP (and sister organizations) – and that the ACP’s response was the functional equivalent of an ethics Dear John letter.

The gist of this formal reply was: “There is no ethical issue here at all. It is quite surprising that anybody would take issue with the New Ethics. And indeed “nobody” has.”

DrRich, suitably brushed off, has already delivered his analysis of the ACP’s statement, a disappointing statement which left the fundamental ethical question (namely, why the New Ethics has rendered covert bedside rationing the ethical duty of physicians) not only unanswered, but unacknowledged. So much for the proposed “debate.”

So DrRich, who back in the day was the recipient of his rightful share of Dear John letters, knows his role here. The ACP is preening for the office of Virgin Queen of the Prom, and DrRich – the jilted boyfriend who knows she’s been sleeping with the lacrosse team – is supposed to keep out of the way and shut up. And so, while he reserves the right to elaborate on some of the more surprising implications of the New Ethics, he recognizes that the ACP (and likely the 120 other physician organizations that have signed on to this manifesto) are very satisfied with their new ethical standards, and are not interested in revisiting them.

But before finally leaving the ACP entirely to its own devices, dear readers, DrRich hopes you will forgive him if he cannot resist commenting on just one more, particularly curious aspect of Dr. Hood’s reply. He refers to her remarkable injunction that, in order to meet their new ethical obligation towards the fair distribution of society’s resources, physicians should engage in “parsimonious care.”

DrRich was pretty sure he knew what parsimonious meant, of course. But the fact that the Chair of the ACP’s Center for Ethics (&c.) was now specifically enjoining doctors to practice medicine parsimoniously made DrRich wonder if perhaps he’d gotten it wrong. So he decided he’d better look it up.

The common meaning for parsimonious, and the only meaning supplied by most dictionaries (such as Webster’s New World Dictionary) conveys the sense of stinginess, or extreme frugality. Other dictionaries and thesauruses suggest: excessively unwilling to spend, ungenerous, penurious, penny-pinching, miserly, sparing, grasping, tight, close, niggardly, illiberal, mean, avaricious, covetous, and tight-assed. Illustrated dictionaries are likely to show a picture of Jack Benny or pre-ghost-of-Christmas-Future Ebeneezer Scrooge, though children’s dictionaries will likely depict Scrooge McDuck, and if progressives had their own dictionary (and they certainly need one of their own), they would show a Republican elephant.

So it would certainly appear that the “parsimonious care” which Dr. Hood urges physicians to adopt hardly seems the kind of medical care patients would hope to receive, or that most doctors would aspire to give.

Perhaps, one might think, Dr. Hood simply misspoke in this instance. Indeed, if one can manage to work one’s way through the entire sentence (which reads, “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.”), it might be just possible to believe that perhaps she only meant “efficient.” And (one might speculate) in her hurry to toss off a quick reply to DrRich this past Sunday, no doubt so that she could get back to the Pro Bowl, she simply chose the wrong word inadvisedly.

But that’s not what happened. Dr. Hood did not misspeak. In fact, these words are not hers. She is quoting here directly from a key part of the ACP’s Ethics Manual.

Bear in mind that before it ever saw the light of day, the Ethics Manual received extremely close scrutiny. The Ethics Manual is a document whose every syllable has gone through numerous and careful edits and revisions, by many well-educated experts. And experts on ethics, out of all the multitudes of wordsmiths residing in the academy, are the most careful and precise with their choice of words. The use of “parsimonious” was not an error, nor could it have been a subliminal choice. Like every other word in the Ethics Manual, “parsimonious” was very carefully considered, and was specifically chosen for its precise meaning. And therefore we can only conclude that what the ACP ethicists mean when they urge parsimonious care is: parsimonious care.

And most assuredly, parsimonious does not mean merely “efficient.” Indeed, the carefully-engineered sentence in which this word appears tells us that, while “parsimonious care” certainly encompasses efficiency, it’s something more than just efficient care. Efficient care is to parsimonious care as fondness is to lust; as a gentle spring rain is to a deadly deluge. “Parsimonious” crosses that line which converts a virtue to a vice.

So yes, the ACP Ethics Manual exhorts physicians to efficient care; but also to something well beyond just efficient care – to parsimonious care. To miserly care; to penurious care; to grasping, tight, close, niggardly, illiberal, mean, avaricious, covetous and tight-assed care.

But, of course, only for the benefit of society as a whole.

Now, if we were actually engaging in a debate (which of course, he recognizes, we are not), DrRich would smugly turn to his opponent at this point and make the following summation: “Since the ‘parsimonious care’ you champion is quite consistent with the new Social Justice mandate as interpreted by me (i.e., a mandate to ration healthcare at the bedside), but not so much with the Social Justice mandate as interpreted by you (i.e., a mandate only to be efficient), I rest my case.” (Note: DrRich is courteous enough not to refer to himself in the third person when engaged in a one-on-one exchange, as that would seem impolite and arrogant.)

Then, DrRich would simply end this post, and wait for the ACP (presumably this time in consultation with the Chair of the ACP’s Center for Lexicography) to attempt painfully to assemble some sort of rebuttal.

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.