In The Million Hearts Initiative, Cardiologists Need Not Apply

DrRich | September 26th, 2011 - 6:52 am

Podcast:

It is a good thing that DrRich is not the only cardiac electrophysiologist writing in the medical blogosphere. If he were, the public would no doubt believe that all electrophysiologists are arrogant, self-important, sarcastic blowhards who insist on expressing themselves in the third person. Fortunately, that DrRich is uniquely afflicted in this manner, and that at least two out of three electrologist appear to be not only brilliant but also reasonably normal people, is nicely demonstrated by the offerings of Dr. Wes and Dr. John M on their respective blogs.

Both of these relatively socially acceptable electrophysiologist bloggers have seen fit to comment on the Million Hearts Initiative, recently introduced with great fanfare in the pages of the New England Journal of Medicine by Drs. Thomas R. Frieden, M.D., M.P.H., and Donald M. Berwick, M.D., M.P.P., on behalf of the United States Department of Health and Human Services. The Million Hearts Initiative aims to prevent a million heart attacks and strokes over the next five years.

The critiques of both Dr. Wes and Dr. John M regarding the Million Hearts Initiative are insightful and well-written, and both offer cogent analyses of the shortcomings of this program. DrRich strongly recommends both for your perusal.

Dr. John M is largely sympathetic with the aims of the Million Hearts Initiative, but finds that at least some of the methods proposed by DHHS to prevent all those heart attacks and strokes are unlikely to do much good. And more importantly, Dr. John notes, the MHI manifesto entirely ignores one of the most important (possibly THE most important) measures to reduce the risk of cardiovascular disease, namely, exercise. Dr. John M is an avid cyclist, and has personal experience with the benefits of exercise. How, he asks incredulously, can you design a major program to prevent cardiovascular events and leave out exercise?

DrRich (who, being a runner for going on five decades, has himself invested much blood, sweat and tears to the proposition that exercise is good for you), also finds this ommission to be quite remarkable. But as usual, DrRich has developed a theory to explain it. Both Dr. Frieden and Dr. Berwick, judging from the string of letters trailing behind their names, are public health experts. Public health experts are known for taking snippets of data from typically flawed clinical trials and, stringing together a chain of mathematical assumptions and conjectures longer than their post-nominal decorations, calculating how many people will be saved (or killed) if this or that public policy is initiated (or withheld). Obviously, for the Million Hearts Initiative, Frieden and Berwick needed to assemble a package of policy interventions whose calculations, when properly jiggered, show that there will be precisely one million beneficiaries. By including exercise in their program (and in their calculations), they would clearly have boosted the results to some awkward and difficult-to-promote value. The “One-Point-Eight Million Hearts Initiative” would just not have had the proper flair.

Like the President says, John, it’s just math.

Dr. Wes is somewhat less charitable toward these eminent public health experts than is Dr. John. John, while criticizing their methods, attributes high motives to them. Wes, on the other hand, is quite cynical about their motives. (In fact, if it were not for his total lack of blustery, third-person-y verbosity, Dr. Wes’ post might well have been written by DrRich.)

Wes suggests that the Million Hearts Initiative is the Feds’ way of distracting the public from noticing that they are doing everything they possibly can to restrict patients’ access to cardiologists, and to restrict spending on cardiovascular medicine.

It is, in fact, striking (at least to cardiologists like DrRich, Dr. Wes, and Dr. John) that this major policy initiative to save a million hearts has no place in it for cardiologists. Cardiologists are never mentioned in the manifesto itself, except obliquely to indicate that their services will not be required. Cardiologists, of course, take care of patients who have already developed significant heart disease. So what the public health experts are telling us is that they are only interested in stopping heart attacks and strokes in people who are apparently disease-free. There’s nothing wrong with that, of course. Preventive medicine is extremely important in cardiovascular disease.

But still. It is at least arguable that the quickest way to prevent a million heart attacks and strokes would be to target those patients who have the highest risk for these events, namely, people with known cardiovascular disease. Cardiologists dedicate their lives to preventing catastrophic events in these high-risk patients – and a tremendous amount of clinical evidence suggests they’re pretty good at it. While the only thing we ever hear these days about stents and implantable defibrillators is that cardiologists over-use them (and so the DOJ is launching criminal investigations to intimidate doctors into using them less frequently), when these kinds of technologies are used appropriately – as they most often are – they are proven to save lives.

But this is most decidedly not what the government’s public health experts are trying to prove. They want nothing to do with actual doctors practicing medicine in the trenches, fighting to save patients with active disease. Rather, they are out to show that the healthcare system can do just fine without all those fancy specialists and all their expensive procedures. They are aiming to advance the Progressives’ long-term agenda of showing that all the really important stuff in healthcare can be accomplished with much cheaper public health initiatives.

As DrRich has pointed out, it is our duty as citizens to maintain our wellness, and the the Million Hearts Initiative is simply the latest initiative by which the Central Authority will help us fulfill that duty. Those who by their own shortcomings develop heart disease or stroke, despite all the wonderful preventive help they receive through programs such as this, have manifestly failed  to fulfill their duty to society and will just have to get by the best way they can. And doctors such as cardiologists, who made the mistake of choosing careers dedicated to caring for such slackers, should not expect to be taken seriously, or overly respected, by the public health experts who are doing the really important work, or by any policy makers for that matter.

None of us cardiologists, nor our patients, should be surprised at being excluded from the Million Hearts Initiative. And won’t we feel bad when the results are in, and it turns out that millions of hearts can indeed be saved without any participation by the heart specialists?

So: Can the public health experts really save a million hearts with the specific steps they say they will take? Examining the strategy which Drs. Frieden and Berwick have laid out in their document, it certainly does not appear so. But, as it turns out, that result will be amenable to “tailoring,” and so the actual values they obtain in their results will be of little consequence.

The Million Hearts Initiative proposes to save a million hearts by doing the following:

A) Make “providers” report more regularly on how well they make little chits on checklists. (These are pretty much the same checklists the providers are already using; it’s the improved reporting standards that will save lives.)

B) Use electronic medical records to track and improve the behavior of providers and patients. (It is not clear exactly how this is supposed to work, though it is easy to imagine many rather spooky initiatives that might be taken, given the creation of a centralized database tracking, among many other intimate details, everybody’s long-term behavioral habits.)

C) Assemble groups of providers into “care teams,” which will somehow employ tag-team counseling efforts to get patients to improve their lifestyles. (Revealingly, it is this gang-nagging, and not novel life-saving technologies, which the public health experts refer to in their document as “clinical innovation.”)

D) Reduce smoking and second-hand smoke. (Fine, but this is merely one of the behavioral changes about which oppressed patients will be mercilessly “counseled” – see Item C.)

E) Get trans-fats out of the food supply. (DrRich has no objection here either, except to note that it was the same public health experts who, 40 years ago, demanded that trans fats be introduced into the food supply in order to crowd out saturated fats.  This is one example of why, when you’re a Progressive, history has always begun just 10 minutes ago.)

And F) Institute a population-wide salt restriction. (This amounts to yet another huge experiment to be perpetrated on the population at large. With luck, after 10 or 20 years this experiment may finally reveal who’s right – the experts who say that a general, population-wide sodium restriction will reduce net mortality, or the experts who say such a sodium restriction will increase mortality. Right now there’s plenty of data to argue for either outcome.)

Will doing these things really save a million hearts? Not in real life. All these things, taken together, don’t amount to very much in terms of actually accomplishing anything useful. But in the final analysis, the public health experts will have a decided advantage. It is plain that, while proving that hearts are actually “saved” by such measures will in fact be impossible, it will be equally impossible to disprove it. This situation is entirely analogous to the one in which the Administration insisted that President Obama’s stimulus package “saved” eight million jobs – since there is no way to prove or disprove that any jobs (or hearts) would have been lost had you done the other thing, any old claim is just as good as the next.  In such situations, the faction which gets to analyze the final data (in this case, those selfsame public health experts) can manipulate the statistical evidence any way they must to “prove” what they aim to prove.

Heck, they probably have their final report written up already.

Readers are advised to forget about saving a million hearts. Instead, save only one. Don’t smoke. Get plenty of exercise. And don’t eat so damned much. And should you develop heart disease despite your best efforts (which happens all too frequently despite what you’ve been told), pray that you can still find a cardiologist who has not been intimidated into withholding those expensive, modern medical therapies that really have been proven to save hearts, and lives.

Attila The Cardiologist

DrRich | August 2nd, 2011 - 6:00 am

Podcast:

Note: DrRich has issued this warning more than once before. It has always gone unheeded. He will now try one more time, with this updated and hopefully more compelling version, not because he actually believes it will do any more good than similar warnings did those other times, but because he is a humanitarian and time is growing short. American physicians will continue to ignore this warning at their own peril.

The history of Western civilization, from prehistoric times until relatively recently (so recently, in fact, that one cannot be absolutely certain the pattern has been broken), has been marked by successive waves of invasions by wild barbarians from the north. (This explains why DrRich will never completely trust the Canadians.)

Every few hundred years, one group of primitives or another – Scythians, Goths, Vandals, Huns, Avars, Norsemen, Bulgars, Mongols, and others named and unnamed – would sweep down upon their betters, upon the more civilized, more culturally and intellectually advanced people to the south, and by the expediencies of slaughter, rape and pillage, would take their land, possessions, freedom, and their lives. The advancing barbarian wave would eventually play itself out, and individual members of the untamed horde would simply settle in place, and over a few generations would become civilized themselves – until the next group of barbarians, in turn, would fall upon them.

It was a cycle as natural as the seasons.

What drove these irresistible barbarian movements? Historians still argue about it. Likely these violent migrations were caused by several different things – famine, plague, encroachment by even nastier barbarians from even farther north, and climate change (though this latter conjecture is now politically incorrect, since the official and proper view of the earth’s climate is that it was absolutely stable for millions of years, until Henry Ford and George Bush came along and bent the temperature curve upwards, like a hockey stick).

The reason DrRich brings all this up, of course, is: to warn his medical colleagues about the cardiologists.

Dear reader, the cardiologists are on the move. Their home turf is being encroached upon, their livelihoods gravely threatened, by the biggest, most ruthless, and most irresistible force on earth – the Feds. And in response they are gathering themselves into a great wave, and they are preparing to overrun the territories of less robust, less terrifying, more civilized (possibly more effete) medical specialists, and make themselves a new home.

Some medical specialists aside from the cardiologists are of course also predatory by nature, but for the most part their territorial incursions are predictable, localized and contained – the orthopedic surgeons and the neurosurgeons, for instance, will fight over lumbar disc surgery. Not so for the cardiologists.

DrRich is a cardiologist, and he knows that the Board Certification papers wielded by cardiologists do not read: “Certified in the practice of cardiac medicine,” but rather, “Certified in the practice of cardiovascular medicine.” Cardiologists, in other words, are officially certified not merely in the practice of heart disease, but also in the practice of any and all disorders affecting the blood vessels.

And DrRich urges his unsuspecting medical colleagues to please notice that blood vessels are prominent features of every organ system in the body. Cardiologists therefore recognize no natural limits to their rightful turf; if it is supplied by the vascular system, it is theirs. And if some other kind of specialist has traditionally claimed sovereignty over some particular organ – say, the liver – their continued success lies entirely in the fact that the cardiologists have not yet chosen to assert their rightful authority. (As it happens, hepatologists are relatively safe, as most cardiologists think of the liver as a particularly uninteresting organ, which, after all, just sits there doing nothing. Many cardiologists, in fact, persist in getting the liver and the kidneys mixed up.) Still, should it ever become convenient for cardiologists to invade the hepatologists’ space, these relatively intellectual, relatively sedentary specialists don’t stand a chance.

What all this means is that when the cardiologists are on the move, nobody is safe. And they are on the move.

Hide the women and children!

The cardiology settlements have been restless for years, continually expanding and growing, and spilling out across their borders to encroach on the turf of their nearby neighbors. They long ago began driving the formerly proud and powerful cardiothoracic surgeons into a sad state of underemployment. More recently they have usurped the formerly sovereign territory of diabetes specialists. They are currently laying siege to sleep medicine (pulmonary specialists) and bariatrics (weight loss specialists). All of these incursions can be related, within one or two degrees of freedom, to heart disease. So these are localized disputes.

But in the last year or so, cardiologists have moved from a state of mere restlessness to a state of high alarm. The ruthless Feds (a mysterious tribe arising from a dark, inexplicable cauldron of a place where even the laws of physics, economics, and human nature do not apply) have taken to attacking the cardiologists where they live – in their home turf of stents and implantable defibrillators. By conducting secret and extensive DOJ investigations as to whether cardiologists are plying their trade according to “guidelines” (a form of tribute acknowledging their state of thrall to the Central Authority), and by threatening to jail them or fine them into professional oblivion (to the point where even the ubiquitous threat of malpractice suits has become a relatively trivial concern), the Feds have forced cardiologists to recognize that it is time for them to move on. It is time to seek out new territory.

There is no telling where they will show up next. If any of you non-cardiologists think you are safe, think again.

To illustrate just how unpredictable the Great Cardiology Migration is likely to become, DrRich will review a few of their recent incursions into the territory of some of the least likely of the medical specialists – the neurologists and the neurosurgeons.

The cardiologists’ encroachment into the field of neurological medicine is not only surprising in itself (for who would have thought that such shoot-from-the-hip, action-addicted specialists would find anything interesting about the brain?), but especially surprising is its scope and its persistence. Cardiologists actually began this process several years ago, under the radar, when they took to blaming imbalances of the autonomic nervous system (i.e., dysautonomia) on mitral valve prolapse. In more recent years, and somewhat more openly, they have attempted to take ownership of migraine headaches.

And now, in recent months, cardiologists have laid claim to the brass ring of the neurological diseases – Alzheimer’s Disease. If they can wrest this common and expensive disorder away from the neurologists, a disorder which people will pay almost any amount of money to prevent or treat, they can set themselves up for generations.

The typical pattern of behavior employed by the cardiology invaders is easy enough to spot. First, they call attention to an alleged association between some cardiac condition (a condition they will manufacture if necessary), and a neurological disorder. 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 demonstrated that the neuro problem is produced by a cardiac condition, it will become necessary to refer patients who have (or might develop) that dreaded neuro problem to cardiologists, who, lo and behold, will have invented a well-paying procedure which they claim will treat it.

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 which requires mitral valve surgery. Fortunately, however, this kind of serious MVP is relatively uncommon.

But happily for cardiologists, 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 referring 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 stable 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 for a few moments 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 when 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 to some extent on how hard the echocardiographer looks for it, and on how much the referring 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 would be 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 decent car payment, doing echocardiograms in those extremely rare young patients with cryptic strokes. 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, at least one can assemble a string of very unlikely events that, should they all occur simultaneously, might possibly produce a stroke. 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 again, 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 for the echocardiograms 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.

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 them all.) One undeniable truth is that merely performing PFO closures on enough migraine suffers is guaranteed to produce a patient here or there who will report a positive response. And despite the continued negativity of actual clinical trials so far, that’s what happened.

So, by anecdote – but not by controlled trial – closing PFOs can cure migraines.

But now it gets even worse for the neurologists. Any 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 are laying claim to Alzheimer’s Disease.

Recently, researchers presented a study suggesting that ablation procedures for atrial fibrillation are associated with a lower risk of subsequent Alzheimer’s disease. (Here’s some information on atrial fibrillation and its treatment if you are 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.

But such objections are just quibbles. When this study was reported, the headlines in the typically discerning American press blared: “Ablation Procedures For Atrial Fibrillation Prevents Alzheimer’s.” Whatever the details and limitations of this study, cardiologists can now treat Alzheimer’s. Mission accomplished.

Then, just last week, the American Heart Association and the American Stroke Association released a formal scientific statement to the effect that vascular disorders are an important cause of Alzheimer’s disease. So this new statement clearly plants the flag for the AHA’s chief constituency – the cardiologists (who, DrRich reminds his readers, own vascular disorders).

Remarkably, the American Academy of Neurology, apparently failing utterly to grasp its significance, endorsed the statement. As a result, American neurologists have formally taken the knee before their new masters.

You see how this works?

Now, having for the last time, with an unerring sense of fair play, called this problem to the attention of his non-cardiologist medical colleagues, DrRich would like to finish by emphasizing an overarching point.

You can’t fight the Feds. When the Central 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), the affected medical specialists have a limited range of possible responses. And fighting the Feds is NOT among these available responses. It would be more effective – and certainly safer – for doctors to fight against the change of the seasons.

So the affected specialists have only two options. They 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 fell upon them. Strike out against other, weaker tribes and take what’s theirs.

DrRich is not passing any judgment on his cardiology brethren here. (Would you have him judge a she-bear protecting her cubs?) He is just describing what’s happening. You who lie in their path 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.

Cardiologists Are Still Missing COURAGE

DrRich | June 13th, 2011 - 7:21 am

Podcast:

In 2007, when the results were published from the COURAGE trial, all the experts agreed that this study would fundamentally change the way cardiologists managed patients with stable coronary artery disease (CAD).*
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*”Stable” CAD simply means that a patient with CAD is not suffering from one of the acute coronary syndromes – ACS, an acute heart attack or unstable angina. At any given time, the large majority of patients with CAD are in a stable condition.
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But a new study tells us that hasn’t happened. The COURAGE trial has barely budged the way cardiologists treat patients with stable CAD.

Lots of people want to know why. As usual, DrRich is here to help.

The COURAGE trial compared the use of stents vs. drug therapy in patients with stable CAD. Over twenty-two hundred patients were randomized to receive either optimal drug therapy, or optimal drug therapy plus the insertion of stents. Patients were then followed for up to 7 years. Much to the surprise (and consternation) of the world’s cardiologists, there was no significant difference in the incidence of subsequent heart attack or death between the two groups. The addition of stents to optimal drug therapy made no difference in outcomes.

This, decidedly, was a result which was at variance with the Standard Operating Procedure of your average American cardiologist, whose scholarly analysis of the proper treatment of CAD has always distilled down to: “Blockage? Stent!”

But after spending some time trying unsuccessfully to explain away these results, even cardiologists finally had to admit that the COURAGE trial was legitimate, and that it was a game changer. (And to drive the point home, the results of COURAGE have since been reproduced in the BARI-2D trial.) Like it or not, drug therapy ought to be the default treatment for patients with stable CAD, and stents should be used only when drug therapy fails to adequately control symptoms.

When the COURAGE results were initially published they made a huge splash among not only cardiologists, but also the public in general. So cardiologists did not have the luxury of hiding behind (as doctors so often do when a study comes out the “wrong” way) the usual, relative obscurity of most clinical trials. Given the widespread publicity the study generated, it seemed inconceivable that the cardiology community could ignore these results and get away with it.

But a new study, published just last month in JAMA, reveals that ignore COURAGE they have.

In a registry-based survey that covered over 500,000 patients treated in over 1,000 hospitals, the new article reports that there has been little change in the use of drug therapy in patients with stable CAD since the COURAGE study was published. Prior to the publication of COURAGE, only 43.5% of patients who received stents had been tried on optimal drug therapy; two years after publication of COURAGE, that number had “increased” to 44.7%. And while the increase was statistically significant, observers have agreed that it is nonetheless trivial, and that the COURAGE trial apparently has made next to no impact on the practice patterns of cardiologists.

This revelation is proving embarrassing to even the usual spokespersons for the cardiology community, the luminaries who are always trotted out to explain the nuances of their colleagues’ sometimes odd behaviors, and to explain why those behaviors, actually, are not only reasonable but commendable. This time they are at a loss.

The best they can do, according to their commentary on TheHeart.org, is to offer two speculations: a) that, sometimes and for mysterious reasons, it can take several years for the results of important randomized trials to “disseminate” down to practicing physicians, and that apparently even the highly-sophisticated cardiology community is not immune to this phenomenon, and b) the cardiologists are waiting for their professional organizations to issue updated “guidelines” on stable CAD that take the COURAGE results into account. (The last official guidelines were published in 2002.)

Regarding this first explanation, DrRich can assure his readers that the results of the COURAGE trial were not slow to disseminate to American cardiologists. The results (and their implications) were, in fact, known immediately to every one – indeed, the buzz was palpable. It was, perhaps, the biggest news in the cardiology world in several years. If any cardiologists missed this seismic event, they are among that tiny, disconnected minority that is still out making house calls and distributing foxglove leaf, and likely would not know what a stent is, let alone be using them indiscriminately.

Regarding the “guidelines” excuse, DrRich is speechless. Since when are cardiologists guilty of following clinical guidelines to a fault?  If doctors, especially cardiologists, are already sticking strictly, in every particular, to sets of guidelines promulgated by committees of distant experts, even when they know those guidelines are out of date and, frankly, wrong, then (if you are an American patient) all is already lost.

DrRich does not buy either of these explanations. So what, then, is the real reason?

Is it greed? This is likely part of the explanation, and is all of the explanation for some cardiologists. (Self-interest plays as large a role in determining the actions of some practicing physicians as it does in determining the actions of those physicians whose reputations and hoped-for futures as “policy experts” requires them to denigrate the motives of practicing physicians every chance they get.) Indeed, DrRich would not be surprised to learn that some cardiologists of a certain age, realizing that the days of wine and roses are rapidly drawing to a close, are scrambling to insert every stent they can – and any other medical accoutrement they can justify deploying – as rapidly as possible, and then get the hell out.

But DrRich is certain that most cardiologists are genuinely trying to do what is best for their patients, and he believes that the failure to respond to the COURAGE trial is too generalized and too widespread to attribute entirely to greed.

Rather, DrRich believes that the results of the COURAGE trial simply fly in the face of your typical cardiologist’s world view. And while they undoubtedly understand those results intellectually, and even accept the results explicitly, they are simply having trouble incorporating those results into their conceptual framework for CAD. And since CAD is their livelihood, their philosophy, their sun, moon and stars, this amounts to an existential crisis.

When Galileo championed the Copernican view of the universe, and backed it up with sound scientific observations, he felt his views would receive approbation from the highest authority. After all, his old friend, the intellectual cleric Barberini (who had supported the publication of his book), was now Pope Urban VIII. But, while as Barberini his old friend could afford to be intellectually pure, as Pope Uban he could not. For Urban to accept Galileo’s work would formally call all Scripture into question, and seriously undermine the integrity and authority of the organization that had provided structure to western civilization for 1000 years. So Galileo had to suffer.

DrRich thinks that cardiologists find themselves in the position of Pope Urban – having the intellect to understand and accept certain surprising scientific results, but unable to put those results into practice without wrecking an entire way of life, and indeed, an entire way of looking at the world. They can either ignore (with, no doubt, some discomfort) the clear results of COURAGE, or abandon the world view that provides their sustenance and gives their lives meaning. That, DrRich thinks, is the real problem.

Regular readers will know that DrRich is not one to articulate a problem, and then simply walk away, leaving everyone to wonder what to do about it. So, as usual, DrRich has a suggestion.

The cure for the cardiologists’ existential problem is to articulate and accept a new world view, one that incorporates the results of COURAGE (and other clinical trial results that may seem puzzling under the old world view), and which places the proper usage of drugs and stents for CAD into a serviceable framework. While adopting this new world view will not be pain-free, it is one to which cardiologists can adapt – just as the Church eventually adapted to the heliocentric view of the cosmos.

And so, as a public service to his cardiology colleagues (and to their patients), DrRich will articulate a new world view on CAD. DrRich has not himself invented this new world view – most academic cardiologists, he believes, already endorse it, at least implicitly. But an explicit statement of the new world view – and an explicit rejection of the old – may help a few of DrRich’s cardiology friends to begin to accept the new “heliocentric” view of CAD, and thus to cure the existential crisis which (he postulates) is holding them back.

The Old World View

The old world view of CAD goes as follows: CAD produces localized plaques in the coronary arteries, which gradually grow out into the artery’s lumen, causing partial blockage of the artery. These “significant” plaques (generally regarded as plaques that are blocking 75 – 80% of the artery’s lumen) can produce angina (because during exertion not enough blood can get through the partial obstruction), and more importantly, can eventually cause ACS. The ACS occurs because the ballooning plaque can eventually rupture, causing a blood clot to form in the vessel, and producing sudden, high-grade occlusion of the artery.

Therefore, the cardiologist’s job is to identify these significant plaques and to stent them. Doing so will relieve “stable” angina, and will prevent ACS.

In the old world view, CAD is a localized process, that can be adequately treated with localized measures. If the location of the offending plaques can be identified (by cardiac catheterization) they can be treated. Heart attacks and death are thereby prevented.

The New World View

Whether or not CAD is producing a few localized “significant” plaques, the atherosclerosis that causes CAD is a generalized, and not a localized, process. That is, there are usually many plaques within the coronary arteries, most of which are not only “insignificant” (less than 75-80% blockages), but may even be nearly invisible during coronary angiography. Furthermore, it now appears that the majority of heart attacks (and other forms of ACS) occur when one of these “insignificant” plaques ruptures.

This is why it is not particularly unusual for somebody who has a “clean” coronary angiography to have a heart attack soon thereafter. And this is why aggressively treating stable but “significant” blockages with stents does not measurably reduce the incidence of heart attack and death.

CAD is a generalized, progressive disease. The treatment of CAD therefore inherently ought to be a medical (and not a localized, quasi-surgical) process. Ideally, one ought to use drugs that stabilize plaques and reduce the risk of rupture (statins, possibly beta blockers), along with drugs that reduce the propensity of blood to clot within the coronary artery, should a rupture occur (aspirin). And research should be aimed at identifying unstable plaques and finding better ways to stabilize them, and not at tweaking stents to render them marginally better than the prior ones.

A stent is fine to use on a significant blockage that is producing stable angina, but what it is accomplishing, one must realize, is merely to treat the symptom of angina – and not to prevent future heart attacks.

There.*

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* Under the new world view as well as the old, when ACS is actually occurring – when a plaque has ruptured and acute occlusion of an artery is taking place – inserting a stent often appears to be beneficial.
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Now that DrRich has entirely relieved the existential crisis all you cardiologists out there have been experiencing (you’re welcome!), all that remains is for somebody to address those few outliers among you who still haven’t heard about the COURAGE trial, or who are doggedly committed to following approved clinical guidelines under all circumstances, come hell or high water, even when they know them to be wrong, or who are just too consumed by greed to do the right thing.

While DrRich would consider it far from his method of choice for changing physicians’ behavior, and is in fact appalled by it, the Department of Justice’s new policy of conducting, Urban-like, inquisitions against physicians who are slow to adopt the Central Authority’s preferred practice patterns, and then criminally prosecuting those who are slow to comply, should work wonders in this regard.

Advice to Medical Tourists From the American College of Surgeons

DrRich | March 29th, 2011 - 2:41 pm

Podcast:

In an earlier post, DrRich offered several potential strategies for doctors and patients to consider should healthcare reformers ultimately succeed in their efforts to make it illegal for Americans to seek medical care outside the auspices of Obamacare. To those readers who persist in thinking that DrRich is particularly paranoid in worrying about such a thing, he refers you to his prior work carefully documenting the efforts the Central Authority has already made in limiting the prerogatives of individual Americans within the healthcare system, and reminds you that in any society where social justice is the overriding concern, individual prerogatives such as these must be criminalized. Indeed, whether individuals will retain the right to spend their own money on their own healthcare is ultimately the real battle. The outcome of this battle will determine much more than merely what kind of healthcare system we will end up with.

DrRich, despite his paranoia on the matter, is a long-term optimist, and believes that the American spirit will ultimately prevail. So, to advance this happy result DrRich (in the previously mentioned post) graciously offered several creative options that could be employed to establish a useful Black Market in healthcare, which will allow individuals to exercise their healthcare-autonomy against the day when such autonomy again becomes legal. His suggestions included offshore, state-of-the-art medical centers on old aircraft carriers; combination Casino/Hospitals on the sovereign soil of Native American reservations; and cutting-edge medical centers just south of the border (which would have the the added benefit of encouraging our government to finally close the borders to illegal crossings once and for all).

As entertaining as it might be to imagine such solutions, a readily available, though much more mundane, option exists today, which is to say, medical tourism.

Medical tourism is where one travels outside one’s own country in order to obtain medical care elsewhere. It is becoming a booming business. A number of superb state-of-the-art medical centers expressly aimed at attracting medical tourists have been established in the Middle East, Singapore, India, China and elsewhere in Asia. These institutions cater to citizens of the world whose own healthcare systems cannot (or will not) provide in a timely fashion (or at all) the level of care patients may desire. Many of these institutions offer modern hospitals, numerous amenities, luxurious accommodations, attentive nursing care, and top-notch doctors – and they do it all for a tiny fraction of what the same care might cost (if you can even find it) in the U.S. and other “first world” nations.

Obviously, medical tourism is not particularly feasible for medical emergencies such as heart attack or stroke, or for chronic illnesses such as diabetes, congestive heart failure, or Parkinson’s disease, which require frequent visits and long-term management.  What is feasible is to become a medical tourist for those one-time medical services that can be scheduled and planned, for which there is a long waiting period at home, or which is simply too expensive in one’s own country. Such medical services often include coronary artery bypass surgery, hip replacements, knee replacements, and numerous minimally-invasive and not-so-minimally-invasive surgical procedures. In other words, medical tourism to a large extent is something one does for elective (i.e., non-emergency) surgery.

These are the very procedures, as DrRich has pointed out, which are now being covertly rationed in the U.S. thanks to the “never events” policy adopted by CMS and private insurers. As a result, certain categories of individuals may soon find it more difficult to obtain elective surgical services than they might have just a few years ago, and medical tourism may accordingly become a more compelling alternative.

It ought not be a surprise, therefore, that the first organization of American physicians to issue a formal policy statement regarding medical tourism is the American College of Surgeons.

The reaction of American surgeons to medical tourism ought to be obvious. They hate it. Elective surgical procedures – the very procedures for which Americans become tourists – are the bread and butter of most surgical specialties. It pains them to think of their prospective patients going off to Singapore for their lucrative bypass surgeries. American cardiac surgeons, for instance (already underemployed, thanks to American cardiologists throwing stents at every tiny coronary artery indentation they they can justify as a “blockage”), are nearly apoplectic at the idea.

It’s always a delight to read formal policy statements which attempt to disguise an entirely self-serving message as a selfless public gesture. The actual message of the surgeon’s policy statement, of course, is, “We hate medical tourism, and if you do it we’ll hate you,” but they say so on a manner which is designed to be polite, politically correct, non-judgmental, helpful and even friendly.

The surgeons in general have made a good effort, as you can see if you’d like to read the policy statement for yourself. It’s pretty much what you would expect – “Go ahead and have your knee replaced in Timbuktu if you want to. It’s your right, so go ahead and devil take the hindmost. Just don’t come crying to me when things go south a month later.”  They do so, however, in an extraordinarily collegial way.

The artful style of their policy statement aside, DrRich is struck by two aspects of the actual substance of the document.

First, the surgeons begin with a litany of dire warnings regarding all the medical considerations one must take into account before trusting one’s health to foreign medical hands:

“Some of the intangible risks include variability in the training of medical and allied health professionals; differences in the standards to which medical institutions are held; potential difficulties associated with treatment far from family and friends; differences in transparency surrounding patient discussions; the approach to interpretation of test results; the accuracy and completeness of medical records; the lack of support networks, should longer-term care be needed; the lack of opportunity for follow-up care by treating physicians and surgeons; and the exposure to endemic diseases prevalent in certain countries. Language and cultural barriers may impair communication with physicians and other caregivers.”

Obviously, these are all very important considerations. What strikes DrRich, however, is that these are the very same considerations (even the warning about endemic diseases, when one considers the MRSA infections which are secretly “endemic” in some American hospitals) which patients must also take into account before agreeing to receive care in any American institution. It may turn out that these considerations are more an issue in top-notch foreign hospitals than in your average American hospital, but DrRich is not convinced this is the case, and the surgeons do not provide any evidence that it is. In other words, DrRich sees this very good advice as being equally applicable whether one is considering becoming a medical tourist, or just a typical American patient.

Second, and more astonishingly, DrRich notes – not so much with interest, but more with awe – that the surgeons are beseeching their patients to consider just how difficult it might be to launch a malpractice suit against foreign doctors. (DrRich himself does not know how difficult this would be. Given that we are being so strongly urged these days to merge the American legal system with several varieties of international law, it might not be such a big problem.) Indeed, a careful reading of this policy statement reveals that the potential difficulty in suing foreign doctors is offered as the chief differentiator, and thus it has become the primary argument in favor of good-old-American-surgery. The surgeons, in essence, are saying, “Let us do your surgery, because we’re easier to sue if we screw up.”

This, from the very body of American physicians who are most at risk for malpractice suits, and who traditionally have been most vociferous in favor of malpractice reform.

DrRich can only shake his head in wonderment. If medical tourism is viewed by surgeons as such a dire threat that they have embraced, as their chief weapon against it, a celebration of the ease of suing American doctors, why, one can only conclude that medical tourism must have caught on far more than most of us realize.

As an American physician who has always been proud of American medicine, DrRich’s innate tendency is to lament the fact that Americans are finding it to their advantage to travel to Mumbai for their hip replacements. But as a patriot, he celebrates the fact that his fellow citizens are willing to go to such lengths to exercise their individual autonomy. He finds it a hopeful sign.

Our would-be oppressors might find it more difficult to hold us down than they may think.

Who Writes Those Clinical Guidelines, Anyway?

DrRich | January 19th, 2011 - 8:50 am

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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.

Patients, Doctors and Remote Third Parties

DrRich | December 27th, 2010 - 3:02 pm

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From the ominously-titled book, “New Rules,” by Donald Berwick MD and Troyen Brennan MD:

“Today, this isolated relationship [between doctor and patient] is no longer tenable or possible. . . Traditional medical ethics, based on the doctor-patient dyad, must be reformulated to fit the new mold of the delivery of health care. . . The primary function of regulation in health care…is to constrain decentralized individualized decision making.”

Unfortunately, Dr. Berwick’s straightforward formulation of the appropriate role of the individual physician in our reformed healthcare system is not isolated to thinkers of the Progressive persuasion. The notion that most clinical decisions can be usefully made by a centralized authority is attractive even to some conservatives.

For example, a few years ago the noted economist Arnold Kling strongly defended the idea. “My own view is that a remote third party probably can use statistical evidence to make good recommendations for a course of treatment.”

Now, Kling is no far-left radical, pushing for centralized control of healthcare (and everything else). Indeed, he is now with the Cato Institute, and before that he taught economics at George Mason University. So he has earned his conservative and/or libertarian chops.

And to be fair, he is not really calling here for “remote third parties” to have final authority on what’s best for individual patients. Rather, he thinks patients should make that decision for themselves, weighing the recommendations of data-driven guidelines promulgated by remote experts, against the ego-toss’d recommendations from their all-too-fallible doctors, or, as Kling sarcastically refers to them, their “heroic personal saviors.” (Such sarcasm, regular readers will know, is as abhorrent to DrRich as it probably is to you.) Kling is saying: trust patients, armed with good evidence-based recommendations handed down from experts, to make the right decisions for themselves.

In concept even DrRich supports this latter notion. Indeed, a chief theme of this blog has been that doctors have been coerced into such a compromised position by the government and the insurance carriers that wise patients will no longer simply trust their doctors’ advice explicitly. As things now stand, patients who place full reliance on their doctors, assuming that they’ll get all the information they need to make good medical decisions, are putting themselves in peril. Smart patients will seek out all the information they can about their own medical conditions, so they can confirm that their doctors are indeed presenting them with all their reasonable options, and so they can more intelligently evaluate those options. And certainly, expert-endorsed guidelines would be an important part of that research.

But Kling’s remedy – that patients rely on the treatment recommendations made by expert panels as a remedy to the conflicted advice being doled out by their own doctors – is seriously flawed.

The first flaw, of course, is the idea that remote third parties, wielding evidence-based data, can make good treatment recommendations for individual patients. Evidence-based guidelines, almost by definition, are designed to improve the average outcome across a population of individuals, and are specifically designed not to optimize outcomes for each individual within that population.

Second, Kling apparently assumes that the remote third parties who are producing evidence-based treatment recommendations will be acting in a completely objective and unbiased manner. But this can never be the case. A major theme of the Covert Rationing Blog this past year has been to demonstrate that a) clinical science is probably the least exact of the sciences; b) the design and interpretation of clinical studies is inevitably attended by significant bias; and c) therefore, no matter who is producing them – whether it is medical professionals or GOD panelists (Government Operatives Deliberating) – these guidelines will always be produced with a particular agenda in mind. To assume that such agendas will be primarily – or even remotely – related to optimizing the outcomes of individual patients will often be a serious error.

Third, the idea that patients, even very intelligent patients armed with “perfect information,” can by themselves reliably sort through the morass of conflicting evidence and conflicting opinions that invariably inform any set of clinical recommendations (whether made by vaunted teams of completely objective experts from on-high, or by one’s inherently flawed, conflicted and ego-driven personal physician) is simply false. This would be the case even if the healthcare system were perfectly aligned to help patients. Which, of course, it is not. (It is aligned to affect the covert rationing of healthcare.)

Finally, while the advice patients get from their doctors is indeed biased, more and more it is biased (thanks to heavy-handed coercion) in favor of those same central authorities that are commissioning the expert panels.

As a result, patients – especially when they are sick and least able to fend for themselves – are generally incapable of negotiating the gratuitous complexities and hidden hazards laid out before them by a hostile healthcare system, a system which silently prays they will, in frustration, just go buy themselves some alternative medicine remedy, then crawl under a bush and die while contemplating their qi. Indeed, patients are as incapable of successfully navigating such a system as are accused felons of navigating a complex and hostile legal system that’s bent on sending them away for 15-20 years.

It is for this very reason that accused felons are assigned an advocate, an individual who is ethically and legally obligated to take their part, to help them navigate all the legal hazards, to do everything possible to see they are treated fairly, and that they are given every reasonable chance to prove their innocence. Lawyers, as much as we physicians might like to castigate them, are absolutely critical to a civil society.

And this is the reason why patients (according to traditional, though now quaint, medical ethics) are also supposed to have a personal advocate, an individual who is obligated to take their part, to help them navigate all the medical hazards, to do everything possible to see that they are treated fairly and that all available medical options are made open to them, and that they are given every reasonable chance of a good clinical outcome. Patients, in other words, need doctors who are devoted to the classic precepts of their profession. Such doctors, as much as Kling and others might like to diminish their importance, are also absolutely critical to a civil society.

But, as we have seen, and as has been publicly celebrated by Dr. Berwick and others, severing the classic doctor-patient relationship has been Job One under our system of covert rationing – whether that rationing is managed by insurance companies or by the government. Doctors simply cannot be allowed any longer to place their patients first. They’ve got to place the needs of their true masters first. They’ve got to keep the government and the insurers happy or they’re out of a job. They are no longer permitted to tailor clinical choices to best fit their individual patients, but they are simply to apply treatment directives as they are handed down by (from now on, government-appointed) panels of experts.

And this brings us back to Kling. DrRich of course agrees with his notion that patients ought to be armed with the high-quality information they need to determine their own medical destiny. DrRich can even agree that relying solely on the information provided by today’s doctor is generally not advisable. But DrRich cannot agree with the reason it’s not advisable. Doctors aren’t so much inherently flawed by ego and other intrinsic character flaws (at least, no more than any other group of humans), as they are operating under duress, under imposed constraints, and under external coercions that systematically and purposefully prevent them from discharging their professional obligations.

Nor can DrRich agree with Kling’s proposed solution. No centralized set of recommendations, evidence-based or not, can fix this problem for patients – especially when the expert bodies that make those recommendations are controlled by the same entities that have, with malice aforethought, killed the medical profession for the express purpose of stripping patients of their advocates, and therefore, of their medical options.

DrRich has trouble seeing a solution to this problem that is not radical. He does not see how doctors can resume their rightful place as their patients’ advocates and remain in what has become of the traditional healthcare system. Perhaps enough doctors to make a difference will leave the traditional healthcare system, shedding themselves of the third parties who now control their behavior, and re-establishing their practices (and revitalizing their profession) with a new commitment to the doctor-patient relationship. If not, then perhaps some brand new profession will establish itself (call it “personal healthcare advocates”) to fill the great void that threatens the safety of every American patient.

So yes, let individual patients weigh all the evidence and choose the healthcare option that suits them best. But unless they have a personal advocate to help them navigate the morass of biased choices – whether that advocate is their PCP like it’s supposed to be, or some new variety of professional advocate – those options will be limited to whatever healthcare is deemed best by the central planners.

A fine economist such as Dr. Kling should realize that a remote third party can no more make good recommendations for individual patients trying to survive in the rough and tumble of the healthcare system, than can a remote third party make good recommendations for individual businesses trying to compete in the rough and tumble of the marketplace. It is one thing for Progressives to hold to such a notion. It is far more disturbing to see respected conservative thinkers doing so.

How Will Progressives Ration Healthcare?

DrRich | October 25th, 2010 - 7:46 am

Podcast:

In prior posts DrRich introduced his readers to Ezekiel Emanuel, MD, PhD, brother of Rahm, eminent medical ethicist, and one of the White House’s chief advisers on healthcare policy. Dr. Emanuel was one of the authors of that recent paper in the Annals of Internal Medicine which admonished American physicians that resistance is futile. He has also famously called upon American physicians to abandon the obsolete medical ethics expressed in the Hippocratic Oath.

The reason the ideas (and pronouncements) of Dr. Emanuel are important is that he presumably will be a major “decider” in determining who will serve on the GOD panels, and how those panels will operate to advance his (and Mr. Obama’s) program of healthcare reform.

So, before we leave Dr. Emanuel to his important duties, let us take one more pass at the views he has expressed, regarding the direction of American healthcare, which we can expect to see manifested in government guidelines and policies in the coming years.

In particular, and especially relevant to the subject of this blog, let us view how Dr. Emanuel would direct the rationing of our healthcare.

His ideas in this regard were probably spelled out most clearly in an article Dr. Emanuel co-authored in The Lancet, in January, 2009, which proposed a system of healthcare rationing based on what he and co-authors call the “complete lives system.” Most notably, the complete lives system proposes rationing healthcare on the basis of age, in a way that frankly “discriminates against older people” (The Lancet, Vol 373, p 429).

While Emanuel has taken a lot of heat from the right wing for espousing such a thing, his argument for doing so is unique and thoughtful, and DrRich finds it worthy of more careful consideration.

First, we should note that the outrage we often hear expressed at the very idea of healthcare rationing (with each side accusing the other of wanting to ration) only applies to politicians. When healthcare ethicists get together for instance, they (like DrRich) understand that healthcare rationing is utterly unavoidable, and that in fact we’re already not avoiding it. Ethicists argue, instead, about how to do it. In this way, DrRich feels a certain sense of brotherhood with these ethicists (a group which, in nearly every other way, DrRich most often feels a sense of disgust).

So let us consider the ethical argument most often made for discriminating against the elderly in a system of healthcare rationing. Almost always, the argument is a utilitarian one. Saving the life of a 90-year-old might “buy” him only an extra two or three years of life, whereas spending the same amount of money to save a 10-year-old might buy him another 70 – 80 years of life. So society gains much more if it spends the money on the younger person, and withholds it from the older one. From a utilitarian viewpoint the argument for discriminating against the elderly is unassailable.

Non-utilitarian ethics asserts that all individuals have equal value, so discriminating against any person should be avoided, and therefore the 10-year-old and the 90-year-old should have an equal opportunity to receive the medical service in question. (That is, either both should get it or neither should get it.)

DrRich believes that most people would sympathize with the idea that if only one life can be saved, saving a young person’s life might make more sense than saving a very old person’s life. He thinks that even most 90-year-olds he has known would agree with this proposition. The problem, DrRich believes, is with the rationale we use for making such a decision.

The utilitarian argument for discriminating against the elderly in a rationing system rests on the idea (as does all utilitarian ethical reasoning) that individuals are not of equal value, at least, not from society’s point of view. And since they are not equivalent in value, it is right and proper for some agent of society to determine the relative value of individuals, so that resources can be distributed accordingly.

Obviously, utilitarian ethics opens the door for differentiating the intrinsic values of individuals for reasons other than age. That is, if you can devalue the elderly to optimize the public good, then you can also devalue the disabled, the stupid, the lazy, the left-handed, and the obese (for instance) to optimize public good.

Emanuel’s “complete lives system,” he argues, is NOT a utilitarian one. Emanuel would favor treating the 10-year-old over the 90-year-old not to maximize public good, but to maximize the opportunity of individuals to enjoy “complete lives” over the entire age spectrum. That is, under his system all individuals are taken as having equal intrinsic value. And during the course of their lives, everyone experiences an equal spectrum of priorities – first, the priority of a 10-year-old, and later (if lucky enough to live that long) the priority of a 90-year-old. While in practical terms this still means discriminating against the elderly, it does so in a way that cannot be extended to other groups of people (i.e, the disabled and so forth), and that, in fact, yields equal age-based priorities across individuals through the course of their complete lives. In other words, when one considers the entire course of an individual’s complete life, he or she is treated the same as any other individual during the entire course of their lives.

In this way, Emanuel asserts, the complete lives system is not a utilitarian system; while it would allow us to withhold medical care from the elderly, based on their age, it would do so in a way that would not open the door for discriminating against others, for other reasons.

DrRich understands this reasoning because he proposed something entirely similar in his book, as an option for dealing with the age issue in a rationing system. In fact, since DrRich wrote his book a few years before Emanuel published his “complete lives system,” it is entirely possible that Emanuel got his idea from yours truly.

DrRich does not expect any thanks from Dr. Emanuel in this regard, however, and in fact he wishes to thank Dr. Emanuel for showing him the fatal flaw in such thinking. Indeed, thanks to Dr. Emanuel, if DrRich were to produce a new edition of his book, he would propose no such thing.

For, no sooner does Dr. Emanuel propose his complete lives system as an alternative to utilitarian ethical reasoning, than he demonstrates, in the very same article, how easily his system can be twisted to the ends of utilitarian ethics.

Specifically, Emanuel argues that a healthcare rationing system should also discriminate against the very young, and asserts that his “complete lives system” justifies such discrimination (since every individual, at one time in their lives, is very young). But in explaining why it would be desirable to withhold medical services from the very young, Emanuel reveals that his rationale, in fact, is entirely utilitarian:

“Consideration of the importance of complete lives also supports modifying the youngest-first principle by prioritizing adolescents and young adults over infants (figure). Adolescents have received substantial education and parental care, investments that will be wasted without a complete life. Infants, in contrast, have not yet received these investments.” (The Lancet, vol 373, p. 428)

livessavedSo, Emanuel holds that it is OK to discriminate against infants, toddlers and young children on the grounds that society has not “invested” a lot of resources in them yet. That is, their worth to society is not all that great.

This provision is extremely disturbing, to DrRich at least. For it essentially discards the notion that all human lives are of equal intrinsic value, in favor of the idea that an individual’s real value ought to be determined by their worthiness to the collective. And so society has the right and the duty to determine which individual lives are valuable enough to save, and which are not. Note that the rationale for discriminating against the elderly in the complete lives system was framed specifically to avoid having to do this.

In DrRich’s view, this provision against the young entirely negates the purported ethical premise of “complete lives.” This provision is what finally places the state, the insurers, or the GOD panels in the position of assigning intrinsic value to individual human lives, from a distance, as a matter of policy. If this can be done based on extreme youth, then it can also be done based on any other factor which some empowered panel decides will influence the worth of individuals to society.

The above figure, from Emanuel’s article on the complete lives system, reduces the question to a stark graph, with age on the X axis and value to society on the Y axis. Your age is determined by God. Your value to society is determined by the state.

It is easy to envision other, similar graphs, with your worthiness to society plotted on the Y axis, and certain personal features other than age plotted on they X axis – your income, your IQ, your disabilities, your BMI, etc.

DrRich reminds his readers that eugenics has been, from the beginning, an intrinsic part of the Progressive program. The idea that society can (and must) be perfected hinges, to a large extent, on the idea that mankind can (and must) be perfected. And perfecting mankind will require at least some culling of the herd. Indeed, early Progressives unabashedly embraced eugenics as an essential feature of societal perfection – and said so. Theodore Roosevelt, Woodrow Wilson, Bertrand Russell, H. G. Wells, and Margaret Sanger are only the most well-known of the Progressives who openly extolled eugenics.

Openly espousing eugenics became politically inadvisable after the Nazi atrocities came to light. But, since you can never achieve a perfect society while you are “carrying” a large proportion of people who are defective in their bodies, or minds, or thoughts, finding an acceptable way to eliminate such undesirables remains intrinsic to Progressivism.

DrRich believes that gaining control of the healthcare system, and gaining control of who gets what, when and how, provides both a new venue and a new language for Progressives to bring their program to fruition.

He humbly suggests that Dr. Emanuel’s “complete lives system” is an example of this new language, and that it offers a glimpse of what a system of Progressive healthcare rationing will look like.

The Dire Implications For Doctors Of the New Medical Ethics

DrRich | October 19th, 2010 - 7:34 am

Podcast:

In his last post (and in several past discussions) DrRich asserted that the Hippocratic Oath has been declared formally and officially obsolete by the medical profession itself, and that as a result of this action, the medical profession has voluntarily placed the professional viability of all physicians entirely into the hands of the government. Hence, DrRich has postulated, the Amish Bus Driver Rule is thereby activated, which permits (and probably compels) the government to use the leverage of medical licensure to control and direct the behavior of physicians – even their ethical behavior.

Lest anyone think DrRich is exaggerating about this, let us listen to the words of some of the physician-intellectuals who now hold positions of official responsibility, within the Central Authority itself, for determining the behavior of American doctors. DrRich asks his readers to notice both the content and the tone of these words, as both are important.

First, listen carefully to Donald Berwick, MD, recent recess-appointee to the position of head of CMS, in a passage from his ominously-titled book “New Rules,” (co-written with our old friend Troyen Brennan, MD):

“Today, this isolated relationship [between doctor and patient] is no longer tenable or possible… Traditional medical ethics, based on the doctor-patient dyad must be reformulated to fit the new mold of the delivery of health care…Regulation must evolve. Regulating for improved medical care involves designing appropriate rules with authority…Health care is being rationalized through critical pathways and guidelines. The primary function of regulation in health care, especially as it affects the quality of medical care, is to constrain decentralized individualized decision making.”

(Thanks to Dr. Gaulte of the excellent blog, Retired Doc’s Thoughts, for pointing us to this valuable passage.)

Dr. Berwick’s views on the need to constrain individualized decision-making in the practice of medicine is echoed by none other than Ezekiel Emanuel, MD, PhD. Dr. Emanuel is a bioethicist at the National Institutes of Health, and a fellow at The Hastings Center (a bioethics research institution). He is the brother of former White House Chief of Staff Rahm Emanuel (himself an expert in political ethics). Dr. Emanuel was brought in to the Obama administration as a high-ranking adviser on healthcare reform, and is widely expected to have a strong hand in determining who will sit on the GOD panels and how those panels will operate.

Regular readers will recall that Dr. Emanuel is also the co-author of that infamous paper recently accepted for publication in the Annals of Internal Medicine (and whose editors, thereby, formally auditioned for seats on those GOD panels) which called upon American physicians to abandon their ancient tradition of primarily serving their patients, and instead embrace their true destiny, which is assimilating into the Borg.

DrRich has found two instances in Dr. Emanuel’s writings in which he specifically commented on the obsolescence of the Hippocratic Oath.

In the May 16, 2007 issue of the Journal of the American Medical Association, in an article entitled, “What Cannot Be Said on Television About Health Care,” Emanuel expresses the following complaint about American physicians: “Reasoning based on cost has been strenuously resisted; it violated the Hippocratic Oath, was associated with rationing, and derided as putting a price on life, akin to the economist who knew the price of everything but the value of nothing.”

In the June 18, 2008 issue of the same journal, in an article on healthcare “overutilization,” he discussed seven factors that drive the overuse of medical services. He identifies one of these factors as a “culture of unwarranted thoroughness” on the part of American doctors, which serves to drive up cost. “This culture is further reinforced by a unique understanding of professional obligations, specifically, the Hippocratic Oath’s admonition to ‘use my power to help the sick to the best of my ability and judgment’ as an imperative to do everything for the patient regardless of cost or effect on others.”

Thus, Emanuel finds that it is a stubborn adherence to outdated medical ethics, which causes doctors to strictly place their individual patient’s interests above society’s interests, that accounts for a substantial proportion of unnecessary healthcare costs.

These passages from the very physicians who are directly driving healthcare policy through the auspices not of professional medical organizations, but through the auspices of the Central Authority itself, are striking in two ways.

First, their directness is striking. Doctors no longer work for the good of their patients; they work for the good of the collective. And heretofore they are obligated to follow the rules which are promulgated centrally, rules backed by the righteous force of the Central Authority, rules whose primary function is to make sure that decisions on medical care will be directed centrally, rather than at the doctor-patient level.

Second, the indignation these passages reflect is striking. The obligation of physicians to follow central directives is not an item of negotiation or persuasion – it is a DONE DEAL. Physicians’ own elected leadership of their own professional organizations – all of them – have formally signed on to the New Ethics, ethics which obligate doctors to practice medicine in a way that follows the dictates of remote panels guarding the interests of the collective  (rather in a way that jealously guards the needs of individual patients). And while this abandonment of an ethical precept that had been in force for over two millennia was promulgated with little fanfare, and while most practicing physicians seem not to realize that it has even happened (though we can be sure that all medical students everywhere are being steeped in it), it is a DONE DEAL.

And doctors who persist in practicing the “old way,” are not only acting in a manner that is “no longer tenable or possible,” but they are also violating the very ethical precepts which their own profession has now voluntarily adopted. They are behaving unethically. They are being evil.

No wonder our physician leaders are indignant. No wonder they have little choice but to divine the necessary “rules with authority” to force these recalcitrant physicians to do their self-admitted duty to the collective. By persisting with their old fashioned ideas in the face of that which medical ethics now prescribes, doctors are forcing the Central Authority to take strong action. Fortunately, since (we all know) our government is a benign entity, it will begin gently, with tough central rules and regulations (backed by authority) to “constrain decentralized individualized decision making.” The Central Authority will only invoke the Amish Bus Driver Rule (or worse) if these kinder, gentler steps fail.

As for the doctors who do not like this new reality, DrRich has a harsh message. You brought this on yourselves, by allowing your professional organizations to propose, write, and adopt these “New Medical Ethics.” For all the statements of Berwick, and Emanuel, and other health policy experts, castigating you for your inadherence to these new ethics, are predicated on the fact that you have a formally-adopted obligation to follow them.

It does no good to protest that you yourself were unaware that your profession has taken this formal action. Just as President Obama is your President whether you voted for him or not, the New Ethics is your formal rule whether you agreed with it (or were aware of it) or not.

And if you do not like the idea that the details of your behavior as a practicing physician are going to be handed down from on-high, and that you are not to be permitted any longer to primarily advocate for your patient, against the competing interests of the slavering Central Authority, you have nobody to blame except yourself.

And what this tells us is that if you are going to change things, you cannot hope to seek relief from legislators, or from your medical leadership (which has already assimilated with the Borg). Your only hope is to begin by reclaiming your profession yourselves, and re-asserting your primary obligation to your patient. There are several ways to undertake such a course, all of which will require standing up to the government and to your own leadership, and all of which will be difficult and dangerous at this late stage.  But it is the only path that remains open to you for your professional salvation.

Just keep this undeniable fact in mind: Obamacare, or any other form of centralized control over the practice of medicine, can only be achieved with the active acquiescence of physicians themselves. If physicians decide they simply will not allow themselves to be coerced to unethical medical actions, and insist on reestablishing the doctor-patient covenant as the guiding precept of their profession, the entire house of cards will fall. Physicians are far from powerless, if they would only dare to act.

We will still need healthcare reform, to be sure, but physicians have the power to insist that it can only be a kind of healthcare reform which fully honors and guarantees that covenant.

Should PCPs Begin Packing Heat?

DrRich | September 29th, 2010 - 9:54 am

This is a delicate topic, and even DrRich (who has displayed on these pages a willingness to risk alienating Progressives, Conservatives, President Obama’s minions, fat people, editors of prestigious medical journals, global warming enthusiasts, babies, bunnies, and even his beloved fellow cardiologists) is hesitant to bring it up.

But events force DrRich to throw caution to the wind, and issue a warning, and a plea, to those among the broad community of physicians for whom he has the most respect – the PCPs. The event to which DrRich refers, of course, is the recent, tragic gunning-down of a physician at Johns Hopkins University Hospital by a disgruntled patient (or rather, by the clearly disgruntled son of a possibly disgruntled patient).

This is DrRich’s warning: the recent shooting at Johns Hopkins may indicate that the long-predicted (predicted by DrRich, at least) bloodbath of American PCPs may now be at hand. And this is his plea (and here is where even the usually audacious DrRich must admit to a slight bit of trepidation): PCPs, for your own good, for the survival of primary care medicine, and therefore for the success of Obamacare, you must now prepare to defend yourselves.

Yes, dear readers, it is time for American PCPs to begin packing heat.

DrRich well understands that many of his readers at this moment doubtless think he has, at long last, lost it; that his finely-honed (and amply-demonstrated) abilities in logical discourse have finally taken their leave, that he has, sadly, gone ’round the bend. DrRich forgives you for this reaction.

After all, the doctor who was shot (whose identity has not been disclosed, but who is apparently expected to recover fully), works at Johns Hopkins, one of the premier medical institutions in the world. And therefore, while its leaders undoubtedly give the requisite lip service to the importance of primary care medicine, Johns Hopkins likely does not have very many actual PCPs frequenting its premises. So (DrRich’s clever readers correctly surmise), it seems very unlikely that the shooting victim was a PCP; and for him to find a lesson for PCPs in this unfortunate incident is obviously too ridiculous for words.

DrRich does not take such criticism personally. He realizes that those of you who doubt him in this case are not being mean-spirited, but merely misinformed. DrRich accepts the fact that most of you do not scour the relevant scientific literature with as much care as he does. And so, he does not expect you to be aware of the recent work of one David Fishbain, Professor of Psychiatry and Behavioral Sciences at the University of Miami, who published a study in NewScientist Magazine which indicates that up to 1 in 20 patients would like to kill their primary care physicians.

Professor Fishbain learned this interesting tidbit in a survey he conducted among 800 patients undergoing physical rehabilitation or suffering significant pain.

Those PCPs who are reading this startling news, and who, by virtue of the fact that they are still working as PCPs, have have most likely honed their skills of denial to a high art form, are doubtless consoling themselves at this very moment with this observation: “Sure they want to kill me. But as they’re disabled, their chances of success seem low.”

So chew on this. In a control group of patients who were not suffering from pain or disability, Fishbain reported that “only” 1 in 50 admitted to having murderous tendencies toward their PCPs.

Any way you cut it, the math is not pretty: the typical PCP with a patient load of 3,000 souls can assume that at least 60 of these individuals (up to 150, if he/she treats a lot of patients with pain or disability) would not only like to see them dead, but would be pleased to be the instrument of their demise. Worse, even these statistics are surely unreasonably cheerful, as they rely on the likelihood that everyone who wants to see their doctor lying lifeless in a pool of blood are comfortable admitting this fact to medical researchers doing written surveys.

In any case, whatever the specialty might be of the physician who was shot at Johns Hopkins, it is the PCPs who are at the highest risk. And now that the shooting has actually begun, DrRich does not think PCPs should take much comfort in the possiblity that the first casualty may not have been one of them.

Why are patients murderously angry with their PCPs? Let us count the ways.

DrRich has expended much space and effort on this blog describing how PCPs have been maneuvered into covertly rationing healthcare at the bedside. Patients who go to their guideline-compliant, non-fraudulent PCPs these days will find themselves limited to 7.5 to 12.5 minutes of actual face time, most of which their doctor will spend sitting at a keyboard, staring at an LCD screen, desperately attempting to make the appropriate clicks on the most favorable little boxes next to a government-sanctioned Pay For Performance checklist. There will be little or no time for whatever pressing issues may be on the patient’s own (non-government-approved) agenda.

The patient, who has waited weeks for this opportunity, will be asked to wait weeks more for another appointment to discuss those other things – or will be directed to an emergency room.

But the greatest sin of all is that, to assuage their guilt and to make such behaviors seem less than reprehensible, physicians have allowed their professional organizations to formally adopt a new code of medical ethics, one which charges physicians with the task of achieving a just distribution of healthcare resources – namely, with covert healthcare rationing at the bedside. This new ethical obligation officially drives a stake into the heart of the classic doctor-patient relationship, and is an abject admission that the practice of medicine no longer constitutes a real profession.

Patients may not know the niceties of this New Age medical ethics – they may not be able to articulate the reasons they feel abandoned in their hour of need – but they certainly perceive its effects on their lives. Their anger is not unjustified.

The fallout for the medical profession from all these developments has landed disproportionately on the PCP. For most patients, their PCP is the face of the medical profession, and it is in the PCP’s office where they most often experience the changes.

PCP’s, of course, are no happier with this new reality than are their patients. The loss of their professional integrity and their ability to act as autonomous advocates for their patients has (far more than the steady ratcheting down of their pay) made primary care medicine an exquisitely unattractive proposition, both to current practitioners and to potential future PCPs.

Unfortunately, any notion that this damage to primary care medicine can be readily reversed is sadly mistaken. It would be a great mistake, for instance, to place the blame for all this on Obamacare. While Obamacare will indeed utterly rely on PCPs to do the dirty work of covert rationing, the basis for such reliance was established long ago by the medical profession itself, which voluntarily adopted their New Age ethics several years before anyone had ever heard of Barack Obama or his healthcare reforms.

So it should be no wonder that patients are pissed. And since that which is pissing them off is not going away anytime soon, and indeed is about to become greatly accelerated, PCPs must be alert to the likelihood that the lethal ideations entertained by a small but not insignificant proportion of American patients may soon find an outlet beyond mere daydreaming. The Johns Hopkins shooting ought to be a wake-up call to all doctors – but especially to the American PCP.

And so, as a public service, DrRich reluctantly suggests that perhaps it is time for PCPs to prepare to defend themselves in one of the few ways they have left to do so.

PCPs may have lost everything else, but to this point, at least, they still have the second amendment to rely on.

The Inevitability of Bias in Clinical Research

DrRich | September 23rd, 2010 - 6:47 pm

DrRich has said many times that clinical science is among the least exact of the sciences, and therefore, the results of clinical research are particularly susceptible to “spinning” by various interested parties, in order to yield the kind of results they would prefer to see.

Until recent times in American medicine, the parties who have been most interested in spinning clinical research have been the people who run drug companies and medical device companies (who need clinical research which supports the use of their products), and the medical specialists (who are more likely to be paid for performing medical procedures that are supported by clinical research). In writing about such data-spinning abuses, DrRich has particularly targeted his own Cardiology Guild, but only because he knows and loves cardiologists the best. He suspects that other specialists are doing exactly the same thing.

While DrRich has used reasonably gentle humor (laced, to be sure, with sarcasm and irony) to criticize doctors and their industry collaborators for twisting clinical data to their own ends, others have expressed the same concerns in much more indignant terms, and have threatened to employ professional sanctions, civil and criminal penalties, and everlasting perdition, to curtail such behaviors.

(Indeed, DrRich has always suspected that the real reason President Obama has not closed Guantanamo is so he has someplace to send recalcitrant American physicians who persist in accepting logo-ed plastic pens from drug reps, or who refuse to accept reduced Medicare/Medicaid reimbursement schedules, or who engage in the black market healthcare activities the President surely understands he is provoking. The one thing that can torpedo Obamacare completely is if American doctors refuse to go along, and any physician who shows signs of doing so will have to be dealt with harshly – if not by detention in exile, then by some other method.)

There is nothing wrong with a little old-fashioned American Puritanism, of course, and physicians and companies who behave badly ought to be punished. But DrRich begs his readers to understand that the inevitable bias in clinical research is not one-sided; it cuts both ways. And clearing the field, so that the only entities which are left to spin clinical research data will be the government-controlled expert panels, is a very bad idea.

DrRich must remind his readers that Obamacare provides for several distinguished expert panels, to be appointed by the executive branch of the federal government, to direct the studies, interpret the results, and apply the results to official reimbursement policies, of a species of clinical research which is called “comparative effectiveness research.”

Comparative effectiveness research comes in two flavors. First, there is the comparative effectiveness research whose unambiguous goal is to compare the clinical effectiveness among different treatment options, so as to offer physicians objective guidance in making the clinical decisions whose results are more likely to be clinically favorable to their patients. This kind of comparative effectiveness research is an unalloyed good, and it is as unassailable as babies and bunnies. Then there is Comparative Effectiveness Research (CER), which is to be operated by new government bureaucracies, whose agenda regarding what kind of effectiveness is actually to be compared is intentionally ambiguous, but which at the end of the day will be comparing cost effectiveness, as opposed to clinical effectiveness, so that doctors will make the clinical decisions whose results will be more favorable to healthcare cost containment.

Our policymakers have been studiously ambiguous about what they mean by  Comparative Effectiveness Research.

This ambiguity was made clear during the Obamacare debates when Peter Orszag testified on behalf of the administration before the Senate Finance Committee. When queried by skeptical Republicans on the ultimate goal of the proposed CER boards, Mr. Orszag was evasive. Specifically, when asked by Senator Kyle (R-Arizona) whether the CER board would be empowered to make decisions regarding which medical services will be reimbursed, Mr. Orszag finally replied, “Not at this point,” a reply which did not alleviate the suspicions of the minority party.

To state the ambiguity more plainly, it is clear that while the government’s CER panels will mainly be concerned about comparing cost effectiveness, the only kind of effectiveness they are willing to discuss publicly is clinical effectiveness. This studied ambiguity allows proponents of Obamacare to paint opponents of the CER panels as being against the “babies and bunnies” form of comparative effectiveness research, and thus reveal those nay-sayers as being beneath contempt, and unworthy of anyone’s attention. Meanwhile they will be free to advance their real “cost effectiveness” agenda.

Therein, of course, lies the government’s bias regarding clinical research. Since clinical research is the primary mechanism by which Obamacare proposes to cut the cost of healthcare, and since the new government panels provide the chief mechanism for controlling and applying the results of that clinical research, the government will be strongly biased toward research results that point toward the less expensive of the two treatments that are being compared.

The idea that government-controlled expert panels will be unbiased, of course, is so absurd that nobody can plausibly believe it. Where you go wrong, dear reader, is in believing that their bias can only take them so far; that clinical research, being science, will more or less yield the Truth; that while a biased party might shade things a bit in this direction or that, at the end of the day the answer which is reached will approximate the Answer.

In fact, clinical research is inherently biased, from the moment a research study is conceived. And those who conceive of, plan, conduct, and analyze the clinical study have every advantage. (This, indeed, is the very reason why everyone is so indignant about the studies conducted by medical industry and their minions in the medical academy.) That advantage is now, under law, defaulting to the government panels.

To be sure, many clinical researchers believe in their hearts and souls that bias can be eliminated through the use of randomized clinical trials (RCTs). In such trials, “like” groups of research subjects are divided randomly into two or more groups, and each group receives (for instance) a different therapy, whereupon differences in outcomes among the groups are attributed to the different therapies to which they were randomized. Indeed, the widespread belief that RCTs are the necessary and sufficient means to achieve “clinical truth” has become so deeply ingrained within the medical establishment that when anyone (such as DrRich) says otherwise, he immediately reveal himself as a scientific Neanderthal.

DrRich has previously observed that the widespread belief in RCTs has become like a Cult, whose creed can be reduced to three main tenets:

1) Data derived from randomized clinical trials represents Truth.
2) Data derived from non-randomized trials represents Falsity.
3) If you don’t believe this, you are a heathen.

Objective observers will find it at least a little ironic that an attempt to claim the scientific high ground has so obviously resulted in a new religion, replete with its own dogma.

The sad truth is that the results of RCTs are invariably dependent on the bias built into their design, and even if internally they are statistically legitimate, they can often send us down the wrong path.

Those who design RCTs (the smart ones, at least) know this. Like smart trial attorneys, they know the answer before they ever dare to ask the question. So they tailor their “question” in such a way as to yield the answer they want to get. Indeed, if a lawyer should end up asking a question in court that produces an unexpected answer, he or she is completely incompetent and ought to be sued for legal malpractice. In more cases than one might think, the same is true for those who design RCTs.

So, for instance, if you are a payer and want to limit the use of an expensive therapy, you design your RCT so that enrolled patients likely to respond to the therapy are diluted with a broad population of enrolled patients, many of whom are less likely to respond to the therapy, to assure that the average response of the whole population will be quite small. (In many instances the clinical characteristics of the likely responders and the likely non-responders will be reasonably apparent.)

On the other hand, if you are a company that wants to encourage the use of your expensive new product, you design an RCT that preferentially enrolls the relatively small subset of patients who are very likely to respond favorably, and then trust the marketplace (with a tweak from your DTC advertisements) to “extrapolate” the results to broader categories of individuals.

So RCTs do not eliminate statistical bias, as the dogma suggests. Rather, they simply offer an opportunity to control the statistical bias in your favor. Since most doctors (and most regulators, guideline writers, and reporters) don’t seem to get this, it becomes relatively easy to fool them.

What DrRich is saying, with regard to the government panels that will direct and interpret the CER (panels that will determine who gets what, when and how, and who gets paid for it and who doesn’t), is that even if those CER panels were not overtly biased against high-cost medical care, eliminating bias from their clinical research would be impossible. And given that the CER panels are being created expressly for the purpose of reducing high-cost medical care, the bias will likely become extravagant. But since that extravagant bias will be couched within the results of various RCTs, the Cult of Randomization will be invoked as “proof” that this expensive medical treatment is no better than that cheaper one.

DrRich has illustrated numerous times how the results of RCTs can be twisted and spun by interested parties, whether by private or government interests, to achieve the results one wants. The CER panels will (it seems obvious) become masterful at doing this.

The apparently widespread notion that industry-sponsored research is invariably biased, while government-sponsored research is entirely objective – and that therefore, the only thing we need to assure accurate clinical research is to have it all controlled by the government – is astoundingly naive.

DrRich believes that, since we cannot possibly eliminate bias from clinical research, we are more likely to approach the actual Truth if we: a) encourage clinical research by all parties – the government and private entities – so that, at least, we may be more likely to engender a “balance” of results; and b) insist that all clinical research be conducted with complete transparency, so that not only are the results made available to anyone who wants them, but also a complete accounting of all the other aspects of the research – including the study design, conduct of the study, and the analysis of the data.

Since bias cannot be eliminated from CER even if the federal CER panels wanted to (and they decidedly will not want to), then insisting on complete and total transparency (ideally, even to the point of making the raw data itself accessible), will be our chief defense. DrRich assumes, since covert rationing will undoubtedly be the CER board’s main, though unspoken, agenda, that such transparency will not be forthcoming without a fight.

Transparency will be worth fighting for, however. At least some bias in clinical research is unavoidable, so complete transparency is our best defense against the biased application of the results of clinical research, whether it is conducted by companies or CER panels.