In his last post, DrRich demonstrated that our modern American healthcare system proposes to treat individual patients as if they were merely members of a herd of cattle or sheep.*

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*Doctors, on the other hand, will be treated like the border collies who – responding instantly to the various complex whistles, hand gestures, and occasional (less complex) kicks administered by their masters – will keep the herd nicely organized into manageable clusters.
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But we should take note that this systematic, official devaluation of individual worth was not produced out of whole cloth by the Obamacare legislation (nor would it be completely overturned by its repeal). Rather, it has been in the works for several decades, the natural, evolutionary result of a philosophy of healthcare that was all the rage until just a few years ago, but which – mysteriously – we seem to hear very little about these days. DrRich speaks, of course, of managed care.

Like many of the current travesties taking place within our healthcare system, managed care began with a pretty reasonable idea; namely, to apply certain management principles to the healthcare system that have been used successfully in other industries, thereby injecting logic, organization, and accountability to what had been a bastion of disorganization and inefficiency.

The unifying idea behind managed care boils down to one word: standardization. Standardization is virtually a synonym for industry. In industry, standardization is the primary means of optimizing the two essential factors in any industrial process: quality and cost.

This proposition can be stated formally as the Axiom of Industry:

The standardization of any industrial process will improve the outcome and reduce the cost of that process.

If you had a widget-making factory, you would break your manufacturing process down into discrete, reproducible, repeatable steps and then optimize the procedures and processes necessary to accomplish each step. To further improve the quality of your finished product (or to reduce the cost of producing it), you would reexamine the steps, one by one, seeking opportunities for improvement. You would need to understand the process thoroughly, and you would need to collect data about how well the process works. But with the right information, you could almost certainly identify a few minor changes to improve the manufacturing process. The beauty in such a system is that you have only to make one change — to the process itself — and every widget that comes off the line after you make that change will be improved.

So standardization is good. It leads to higher quality and lower cost. Conversely, variation is bad. It reduces quality and raises cost.

Proponents of managed care argued that standardization should be just as useful in healthcare as it is in other industries. As medical care has traditionally been individualized, highly variable, and without any semblance of standardization, there must be a huge opportunity to improve the processes of care and to make them both cheaper and more effective. There is obvious merit in such an idea.

Perhaps the most direct, and the most successful, application of managed care practices to modern medicine was the adoption of “critical pathways” in the 1990s.

Critical pathways are blueprints for delivering standardized care to patients with specific medical problems. Consider a critical pathway for hip replacement surgery. The critical pathway is a specific schedule of which services are to be provided for the patient and when, from the date of hospital admission until the date of discharge (which is, of course, predetermined). Checklists are created for which laboratory tests to order and when, which medications to administer at which times, and which specific complications to check for. Everyone involved in the patient’s care has their own relevant checklist. From the moment of the patient’s hospital admission, the critical pathway predetermines when to take vital signs, when to get the patient out of bed, when to begin physical therapy, and when to provide standardized instructions to the patient before discharge. Every vital service is included, and all extraneous services are omitted.

A “case manager” monitors the care each patient receives under the critical pathway. Every deviation from the prescribed procedure is tabulated as a “variance.” Variances are tracked not to decide who to punish, but to identify areas of the process that need improvement. If too many instances of a particular variance are seen in a critical pathway, then either medical personnel need to be retrained on following the pathway appropriately, or the pathway itself should be changed to reflect more realistic expectations.

Critical pathways, in fact, proved to be extremely helpful in many cases. But of course there were some drawbacks and limitations.

First, critical pathways are only useful for delivering medical services, like elective surgery, in which the process of care can be broken down into a predictable series of discrete, reproducible tasks that generate reproducible results. In other words, industrial management tools only work when the process of care is similar to the process of making widgets.

Critical pathways are almost worthless when you are dealing with medical illnesses in which neither the diagnostic procedures nor the treatments that may be employed can be predicted or, therefore, standardized. For instance, it has proven impossible to develop workable critical pathways to manage patients with congestive heart failure (CHF). Knowing only that a patient has been admitted to the hospital with CHF tells you nothing about whether that patient will require cardiac catheterization, a stent, bypass surgery, valve replacement, a pacemaker, an implantable defibrillator, a mechanical ventilator, a prolonged and complicated stay in the intensive care unit, or just a couple of diuretic tablets and overnight observation. No two patients with CHF are alike; and there is no such thing as a standard patient. Unfortunately, most non-surgical medical services fall into this category.

Second, it turns out that when you are taking care of patients, the Axiom of Industry simply does not hold true. Standardization does not always improve outcomes and reduce cost. The reason for this is: Patients are not widgets. And while in theory everyone seems to agree that patients are not widgets, the implications of this fact appear to escape many of our public health experts.

If you’re a widget maker, deciding between two manufacturing processes is a matter of economics. Nobody expects you to consider the widget itself. The outcome by which you are judged has nothing to do with how many individual widgets get discarded during the manufacturing process or even the quality of the widgets that pass final inspection. Instead, it’s the bottom line: how much profit you make in relation to whatever level of quality you put into the widget. So the quality of the widget is not necessarily maximized, instead it’s optimized, tuned to the optimal quality/cost ratio as determined by the market forces of the day. This is why, for a widget maker, the axiom holds: standardization, by rooting out variability, reduces the cost of making the widget (whatever quality level you choose). This automatically improves the outcome, because the outcome the manufacturer cares about is overall profit.

If instead of running a widget company you’re practicing medicine, the calculus is supposed to be different. You’re supposed to be more interested in how things turn out for individual patients than you are in the bottom line. So an expensive process that yields a better clinical outcome is one most people (patients, at least) would expect you to use, even though it only gets you a healthier patient and doesn’t help your bottom line. A process that increases patients’ mortality rate by five percent is one you should disregard, even if it is substantially cheaper than the alternative. The clinical outcomes experienced by patients — the measure of success you’re supposed to be concerned about — may move in the same direction as costs, or in the opposite direction. But because you’re dealing with patients instead of widgets, the Axiom of Industry doesn’t hold – and outcomes and costs do not always move in the same direction.

So the push to strictly apply managed care techniques to healthcare created a dilemma for doctors. Doctors – the widget-makers in this scheme – tried diligently to apply standardized procedures such as critical pathways to the care of their patients. But the more un-widget-like the medical services they were providing, the more often they were compelled to make “exceptions” to the prescribed standardized process, in order to best serve their individual patients.

Such exceptions are a legitimate and valued aspect of any industrial process. In the widget-making world, exceptions reveal that the process needs to be tweaked to make it more usable. Exceptions lead to further iterations and refinements of the process, and a steadily improving result. Exceptions are what allow these industrial processes to become self-correcting.

But in the messy world of patient care, the exceptions revealed instead that industry-like standardization only works for a minority of medical services. No amount of tweaking can standardize the management of complex patients with complex combinations of illnesses.

It did not take long for doctors to simply stop attempting to use critical pathways for non-widget-like medical services. They did this because they actually cared about what happened to the individual widgets in their charge.

Similarly, it did not take long for our public health experts to recognize the same problem. From their standpoint, however, the problem was not that patients are not widgets. The problem was that the doctors on the scene cared about the widgets. Further analysis revealed that the root of the problem was that classic managed care techniques were administered locally, and therefore the misguided loyalties of the doctors on the scene were allowed to rule the day.

The reason we don’t hear about managed care anymore is that such terminology refers back to those locally-administered, iterative, self-correcting, continuously improving industrial processes. And our public health experts have now realized that this model does not work, and must no longer be encouraged.

The solution to the widget-makers dilemma is to remove the dilemma. Since a dilemma requires one to choose between two bad options, any dilemma can be resolved by simply removing the choice. And this is what has now been accomplished.

There is no dilemma for physicians any more. Clinical decisions are now to be made centrally, through the “guidelines,” handed down by GOD panels (Government Operatives Deliberating), which will prescribe precisely who is to get what, when and how. Doctors are now enjoined, both by law and by the new medical ethics, to follow those “guidelines” to the letter, without exception.

Whoever thought that some day we would fondly recall managed care as the good old days?

Farmer Emanuel has 10,000 head of cattle in his beef herd. He prides himself in staying up to date on all the latest methods, so he knows that adding a certain antibiotic to their feed will reduce the incidence of intestinal infections, and will increase his annual overall yield, measured in pounds of beef, by 7%. Unfortunately, he also knows that roughly one in 200 of his cattle will experience a likely fatal allergic reaction to the antibiotic. It is possible to do a blood test to determine which specific members of the herd are allergic, but the test itself is quite expensive, and the logistics of separating the allergic cattle at feeding time and providing them with their own antibiotic-free feed would be expensive enough to entirely wipe out his savings.

Obviously, the cost-effective solution is for Farmer Emanuel to give antibiotic-treated feed to all his cattle, accepting the losses of a few head as the necessary price for an impressive overall gain in productivity. He would be an ineffective and incompetent rancher indeed if he were to pass up this opportunity to achieve cost-effectiveness.

For the last two posts (here and here) DrRich has had some fun in deconstructing the Sixth edition of the American College of Physicians’ Ethics Manual, and especially in demonstrating how the ACP leadership has managed to wrap its collective tongue around the axle defending its unfortunate choice of the word “parsimonious” to describe the ideal mind-set of the modern physician. In the present post, DrRich will discuss a somewhat more serious aspect of the document, namely, what this re-statement of medical ethics really means, and why it was produced.

The Sixth Edition of the ACP Ethics Manual elevates the term “cost-effectiveness” to an ethical mandate; and furthermore, it locks this often ambiguous term down into its apparently final form, and in so doing formally launches the era of herd medicine.

Until now, efforts at covert healthcare rationing have been aimed mainly at coercing individual physicians to surreptitiously withhold certain medical services at the bedside. Mainly, doctors were to accomplish this withholding of care simply by failing to inform patients of all their medical options, or perhaps more commonly, by painting certain medical options in an unfavorable light (so that, while they were, in fact, offered, they were offered in such a way that the patient would almost certainly turn them down).

What the Central Authority has learned, over the past 15 years, is that this style of covert rationing simply doesn’t work. It still leaves medical decisions up to individual doctors and individual patients, who have apparently continued to act against the best interests of the collective despite all the coercion that has been brought to bear. The end result has been unremittingly bad – healthcare costs have continued to rise at multiples of both the GDP and the general level of inflation. It has become obvious to the Central Authority that, in order to set the matter right, all healthcare decisions will have to be made centrally, from the top down.

Accordingly, during the first decade of the New Millennium we saw a steadily rising emphasis on “guidelines.” Guidelines are not intrinsically a bad thing, and indeed, when properly used can be greatly beneficial to both doctors and patients. But in a relatively gradual process, guidelines came to be spoken of as more than merely guidelines – that is, as more than helpful considerations which doctors ought to take into serious account when deciding what’s best for an individual patient. Instead, guidelines have become directives for definite action.

In 2010, the Obamacare legislation took the concept of “guidelines” a giant step forward, and essentially rendered it a crime for doctors to “violate” guidelines, which are now to be handed down by federally-appointed panels of experts. As if to emphasize this new paradigm, the Department of Justice a year ago began a secretive investigation of an unknown number of electrophysiologists, for alleged violations of guidelines for using implantable defibrillators. We do not know if any criminal charges will be brought (and because the particular aspect of those guidelines which doctors have allegedly violated were based on rather flimsy evidence, perhaps not), but during the past year American electrophysiologists have certainly been intimidated into reducing the number of implantable defibrillators they offer to their patients. (And so, whether any charges come out of this “investigation” or not, mission accomplished!)

Dear Reader, how do you suppose some of these electrophysiologists must feel, after failing to offer implantable defibrillators to their patients who they believe have clear-cut indications for the device, knowing that by failing to offer this treatment their patients may very well (and very predictably) suffer sudden death? At least a few doctors, DrRich warrants, are probably feeling very guilty about it.

And here is the real import of the updated Ethics Manual. It aims to assuage the guilty conscience of physicians who follow handed-down guidelines to the letter, even against their better medical judgment, instead of tailoring the application of those guidelines to the benefit of their individual patients (which, DrRich feels compelled to remind his readers, was the original but now archaic intention of “guidelines.”) Doctors who had been feeling badly because they were preserving their own skin at the cost of their patients’ can now take heart. They are not behaving selfishly at all, the New Ethics assures them. They are in fact acting for the greater good of the collective – and therefore they are obeying a higher principle of ethics than those outmoded principles mentioned in the Hippocratic Oath.

While herd medicine was made the law of the land by Obamacare, until now it was still technically unethical. The ACP’s new Ethics Manual repairs that uncomfortable discrepancy, using, of course, what has become the traditional methodology. (That is, when it becomes  difficult or impossible to adhere to ethical precepts, change them.)

For those who missed it, the relevant passage of the new Ethics Manual states that physicians have an ethical obligation to “practice effective and efficient health care and to use health care resources responsibly. Parsimonious care that utilizes the most efficient means to diagnose a condition and treat a patient respects the need to use resources wisely. . .”

Dr. Ezekiel Emanuel offers the midrash on this passage, in his editorial which accompanied the publication of the new Ethics Manual. Emanuel rhapsodizes that it is “truly remarkable” that an “authoritative medical body [is] using such words as ‘efficient’ and ‘parsimonious’ – and without ‘qualifications’ – to describe the ideal physician’s practices.” Dr. Emanuel notes further that to fulfill this new ethical obligation toward efficiency and parsimony, the Ethics Manual specifies that doctors should act based on “the best available evidence in the biomedical literature, including data on the cost-effectiveness of different clinical approaches.”

And that, readers, is the key, for it specifies how doctors, in pursuit of the new ethics, are to act. They are to follow the “best evidence,” in particular, the best evidence on “cost-effectiveness.”

In the past, when doctors were exhorted to practice cost-effectively, the term was used as a general admonition to not be wasteful. But here, in this formal ethics document (as in the Obamacare legislation), it has now become a term of art. “Cost-effective” now has a specific meaning. It is cost-effectiveness as determined by “best evidence,” and since any body of clinical evidence will inevitably have conflicts, and since doctors cannot be expected (or permitted) to determine for themselves which evidence is best in every clinical situation, Dr. Emanuel is talking about the “best evidence” which will be determined by one of his panels of experts.

Therefore, the ACP’s new Ethics Manual stipulates that it is now an ethical obligation for doctors to follow expert-produced guidelines to the letter.

But in the real world, there is no single “best” determination of cost-effectiveness. This is because any determination of cost-effectiveness depends entirely on who is making the assessment. For instance, when DrRich was deciding whether to buy a smoke alarm to protect himself and his family from dying in a fiery inferno, he judged it to be cost-effective to do so. For a mere $20, DrRich was able to protect himself and his family from death or injury, in the unlikely event that a fire should occur in his home. A bargain to be sure, and at least by DrRich’s lights it was highly cost-effective (if only for the peace of mind it brought him).

But if the purchase of fire alarms was covered under Obamacare (and why should it not be, since fire-related injury is certainly a medical problem, which produces a burden for our healthcare system), then the cost effectiveness calculation would look very different. For while fire alarms indeed save lives, they do so at an exorbitant cost – likely more than a million dollars per life-year saved. Clearly, from the perspective of the collective, the purchase of fire alarms ought to be made illegal, and owning one a crime.

And the only reason it’s not a crime is that such Fire Protection Appliances have not (yet) been designated as being subject to the rulings of the US Preventive Services Task Force.

It is axiomatic, therefore, that the assessment of the cost-effectiveness of any product or service will depend on which party of interest is doing the assessment. And often, what might very well be considered cost-effective by an individual might just as well be considered criminally cost-ineffective by the collective.

And so we have the situation, under both Obamacare and now under the new code of medical ethics, in which doctors are obligated to practice medicine cost-effectively, and the kind of cost-effectiveness being referred to is decidedly NOT the kind that applies to individuals. It’s the kind that applies to the collective.

Those assembling the GOD panels (Government Operatives Deliberating) – the panels which will determine the most cost-effective way to practice medicine, and which will distribute rules down to American physicians for deciding who gets what, when and how – tell us that what’s good for the herd is certainly what’s good for the individual. Indeed, this is the precise message of Dr. Hood, president of the ACP.

For the majority of Farmer Emanuel’s beef cattle, this may very well be the case. But for the unfortunate beeves who will turn out to have a fatal allergy to the antibiotic, and who could have been saved with a little extra effort aimed at optimizing the results for every individual, well, not so much. (Progressives like Keynes have been known to justify such results by noting that whatever we do has limited significance for individuals, since, in the end we individuals – like the beef cattle – are all dead anyway.)

Until last week American physicians were ethically obligated to optimize their medical care for every individual, as difficult and dangerous as it has become for doctors to do so in recent years.  No doubt some of them will be relieved to know that their ethical obligations now have been formally changed, to comport with the requirements of their masters, and the facts on the ground.

So open wide and say Moo.

The American College of Physicians published the Sixth Edition of its Physicians Ethics Manual yesterday. Regular readers may find it surprising to hear DrRich say that there is little objectionable in it, and actually much to admire – that is, when it is considered as it is written, as a stand-alone document.

But of course, when it comes to statements of medical ethics in the New Millennium, one cannot rely on the face value of the written word. For the purpose of the modern medical ethicist is to supply a plausible justification for the covert rationing of healthcare. That is, they need to make it ethically justifiable (if not ethically mandatory) for doctors to ration their patients’ healthcare at the bedside. Because statements of medical ethics cannot just come out and say that, ethicists must compose these statements quite artfully, so that when somebody (like DrRich) calls them on it, they can indignantly deny any such thing.

Therefore, DrRich submits, an accurate interpretation of the ACP’s New Ethics Manual requires an exegesis – that is, it requires that we go beneath the actual words, that we explore the derivation of this text, in order to discover its true underlying meaning. Fortunately, this process will be pretty straightforward, and will not require us to have a working knowledge of Latin, Greek or Hebrew. Plain English will do, as long as we keep the true aim of the modern medical ethicist in mind.

Accordingly, we need to begin this exercise by reminding ourselves of what that true aim is. This was probably stated most clearly in a quote DrRich has used before, by Dr. Berwick and his co-author Dr. Troyen Brennan (another ACP ethics maven) in their 1995 book, “New Rules.” To wit: “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.”

That is, the primary aim of the new medical ethics is to get doctors to stop focusing on the specific, unique needs of their individual patients, and instead to focus on what is best for society – which means acceding to centralized, collectivized decision making (the opposite of the decentralized, individualized decision making which the ethicists are pledged to constrain). For doctors to do so, of course, will utterly violate the primary ethical precept which the profession has followed for more than two millennia, and so, obviously, if only for the sake of appearance, will require some revision of those ethical precepts to accommodate the new reality.

And that is the program of the modern medical ethicist.

They have been at this for a long time (at least since the early 1990s), and the Sixth Edition of the ACP Ethics Manual – despite its largely benign language and even occasional retrograde pledges to the needs of the individual patient – advances the true aims of the medical ethicists to a new level. DrRich will provide three lines of evidence to support this contention.

First,

in its section on “Professionalism,” the new Ethics Manual defers specifically to a foundational document written by the ACP and published in 2002 entitled, “Medical Professionalism in the New Millennium: A Physician Charter.” That Charter, which DrRich has critiqued in detail, established a new ethical precept which physicians must now follow – and to which they must give equal weight to their ancient duty to the best interests of their patient. That new precept is to social justice – to a just distribution of healthcare resources.

To understand the real import of this new ethical precept – which is introduced in the Charter in a determinedly bland manner – we must do a brief exegesis of the Charter itself. Notably, the first sentence of the Charter, which attempts to explain just why such a new charter on medical professionalism is needed in the first place, says, “Physicians today are experiencing frustration as changes in the health care delivery systems in virtually all industrialized countries threaten the very nature and values of medical professionalism.”

While this sentence obviously expresses the utter frustration doctors were feeling at being coerced – at the time mainly by health insurers – to withhold expensive but potentially useful healthcare services from their patients, the document itself never spells this out. Indeed, after this passionate opening sentence, no reference to any particular frustration is made again. Rather the document immediately retreats into a bland prose, and one looks in vain for the authors to spell out the cause of the dire frustration that demands a restatement of medical professionalism.

But even though the document seems strangely reticent to say what frustration produced the very impetus for its creation, we can rely on the fact that the document must be designed to cure this mysterious frustration (whatever it is), and further, that the only substantial change in the document was an addition to the code of medical ethics, adding the requirement that physicians work for social justice. Making social justice an ethical mandate for individual physicians, one can only surmise, might help relieve some of the guilt (and some of the frustration) physicians feel when they are forced to engage in bedside rationing against their patients.

The blandness of the Charter is intentional, and was added at the last minute to “soften” the blow. In an ACP policy conference held in the summer of 2001, a much more inflammatory draft of this new Charter was presented to the membership for discussion. That penultimate version made the actual intent of the document far more explicit. It said that when making decisions regarding individual patients, doctors must “be aware that the decisions they make about individual patients have an impact on the resources available to others.”  In other words, it explicitly instructed bedside rationing. To the dismay of the ethicists who had presented the draft, several ACP members at that conference reacted quite negatively to it. (Who knew that doctors still gave so much weight to ancient, outdated ethical precepts?) Because of the uproar, the language of the document was softened before its official publication. While its import remained entirely unchanged, the document was “blanded-up.” In particular, the sentence explicitly spelling out just what the authors meant by “social justice” was removed. In making their final revision, however, the authors of the Charter managed to overlook the passionate tone of that (suddenly incongruent) opening sentence, and thus left an everlasting clue as to what the document was really intended to do.

To summarize, by the turn of the millennium doctors were being coerced to withhold healthcare from their patients at the bedside, and thus to violate their time-honored primary professional directive. The intent of the 2002 Charter on medical professionalism was to repair the problem (i.e., to cure the “frustration”), not by confronting the forces of evil doing the coercion, but rather, by simply changing medical ethics to make bedside rationing OK. And that’s just what the document did, though only after careful re-editing to make this radical change to medical ethics sound as benign as possible.

By explicitly endorsing the 2002 Charter on medical professionalism, the Sixth Edition of the ACP Ethics Manual thereby endorses healthcare rationing at the bedside – but it does so quietly, at arm’s length, so as not to stir up unwanted passions.

Second,

the publication of the new Ethics Manual is accompanied by an editorial written by Ezekiel Emanuel, MD, a celebrated medical ethicist, the brother of Rahm, and a special advisor on health policy to the White House. It is widely believed that Dr. Emanuel will have a lot to say about which medical experts are going to be appointed to Obamacare’s GOD panels (Government Operatives Deliberating) – the panels that will establish the formal “guidelines” to determine which patients will get what, when and how, “guidelines” which doctors will have to follow in every particular, or be subject to fines, loss of profession, and imprisonment.

It is therefore instructive that Dr. Emanuel is effusive in his praise of this new ACP Ethics Manual. He is especially delighted that the authors have placed a statement into a special “call-out” box, so nobody can miss it, demanding that physicians, as an ethical duty owed to society, must practice efficient, parsimonious, and cost-effective healthcare.

Emanuel notes that “These positions on efficiency, parsimony, and cost-effectiveness constitute an important shift, if not in ethics then in emphasis.” Dr. Emanuel need not dissemble. It’s a shift in ethics all right – just look at the title of the document.

In other words, dear reader, we have Dr. Emanuel, one of the Supreme Beings who will be directing the GOD panels, declaring that, thanks to the new ACP Ethics Manual, doctors have now fully accepted the proposition that it is a matter of medical ethics for “cost-effectiveness” – as determined by panels of hand-picked experts – to decide whether their patient will receive a potentially beneficial medical service.

(Judging from Dr. Emanuel’s reaction to their work product, if any of the authors of this new Ethics Manual had hoped their participation might serve as their audition for one of the GOD panels, it appears their strategy might work out just fine.)

Third,

the Ethics Manual contains the injunction that doctors practice medicine “parsimoniously.”  While Dr. Emanuel is enamored by and delighted with this word, DrRich finds it at least a little disturbing.

One might speculate that by this word the ACP’s medical ethicists mean to say that doctors ought to arrive at a care plan by applying the “theory of parsimony,” best known as Occam’s Razor. If so, they are urging doctors to error.

The theory of parsimony says that when a series of observations has more than one plausible explanation, the simplest of the available explanations should be considered the “best.” This method usually works quite well when one is devising a theory to explain some phenomenon whose explanation is not a matter of dire urgency. So, for instance, any cave man from the Paleolithic Age who was fond of Occam’s Razor would have concluded, from available observational data, that the sun revolves around the earth. This conclusion was wrong, but little harm was done by it. And when it became important for us to get the movements of the heavenly bodies right (for instance, when we decided to send men to the moon), we first took care to collect additional observational data (just to make sure), and thereby we discovered just in time (a mere few hundred years before launch) that, for a million years or so, our original conclusion had been mistaken.

But Occam’s Razor is less well suited for making medical decisions, that is, in cases where current clinical evidence is consistent with more than one explanation. Here, it is likely that with some effort a discoverable, definitive, correct answer could be achieved, and it is at least possible that always choosing the “simplest” possible explanation would lead the doctor to take action (or more likely, to withhold medical services) that would cause the patient to suffer harm. Sometimes the theory of parsimony can be applied to good effect in the practice of medicine; other times it will be a disaster. Deciding when to use it is a matter of medical judgment and medical experience, best decided locally by a specific doctor on behalf of a specific patient.

The theory of parsimony clearly should not be applied as a matter of course to all medical questions, perhaps not even in most medical questions. So it would seem a shame for the ACP’s Ethics Manual to decree (“without qualifiers,” as Dr. Emanuel approvingly notes) that as a matter of medical ethics, doctors must always do so.

But perhaps the authors were not referring to the “theory of parsimony” at all. Perhaps they were just using “parsimonious” as a synonym for “efficient.” If this is the case, their error was more along the lines of a Freudian slip. For “efficient” and “parsimonious” are simply not good synonyms. Better synonyms for parsimonious would include:

• excessively unwilling to spend,
• ungenerous,
• penurious,
• penny-pinching,
• miserly,
• sparing,
• grasping,
• tight,
• close,
• niggardly,
• illiberal,
• mean,
• avaricious,
• covetous, or
• tight-assed.

Efficient is to parsimonious as fondness is to lust, or as a gentle spring rain is to a deadly deluge. They may be in the same genus, but are of entirely different species.

Since the real synonyms for parsimonious are all quite descriptive of bedside healthcare rationing, DrRich submits that this carefully chosen and strongly praised word is every bit as appropriate to the occasion as Dr. Emanuel indicates. This is EXACTLY how our Central Authority wants doctors to practice medicine – parsimoniously.

In conclusion,

the wording of the new ACP Ethics Manual itself may be, with a few notable exceptions, inoffensive. But when we take the time to explore the derivation of this text, when we consider it in light of the overarching program of modern medical ethicists, and in light of the interpretations now being assigned to it by agents of the Central Authority, it is not difficult to discover its true meaning and its true significance. This document helps establish an ethical mandate for doctors to follow centralized clinical directives to the letter, and doctors who fail to comply will be guilty not only of some legalistic violation of “guidelines,” but also of behaving unethically. And almost anyone will tell you that unethical doctors are the lowest form of life; for them no punishment is too harsh, and the tiniest mercy is too kind.

This, of course, is just what we should have expected.

Ten: The Right To Bear Salt

Nine: About Those Doctor-Nurses

Eight: The Four Ways To Reduce Healthcare Spending

Seven: On Killing The Elderly

Six: The Real Utillity of “Never Events”

Five: Who Writes Those Clinical Guidelines, Anyway?

Four: DrRich Explains The Right To Healthcare

Three: It Is Your Duty To Maintain Wellness

Two: Primary Care Is Dead: Part I – The Obituary;  Part II – Moving On

One: Why People Think Obamacare Has Death Panels

Read them and weep.

DrRich has written a lot on this blog about the intentional destruction of the classic doctor-patient relationship. That relationship, of course, was a fiduciary one, under which the patient was encouraged and expected to place full trust in the doctor’s sacred duty to put the patient’s own best interests above all other considerations.

Obviously, such a thing is incompatible with a healthcare system in which doctors are expected to covertly ration healthcare at the bedside. Indeed, it was the ethical tension between what the classic doctor-patient relationship required and the new duties of physicians in the real world, that led professional medical organizations to formally re-define medical ethics in 2002.

And today, of course, under these New Age medical ethics, doctors are no longer expected to place the needs of their individual patient first. Rather, they are required to make the needs of the collective – that is, social justice – their chief consideration.

When the needs of the individual and the needs of the collective coincide, of course, so much the better. But when they do not – and they frequently do not – the needs of the collective take precedence. And “the needs of the collective” are now being determined by panels of experts created under Obamacare, which are busily devising the “guidelines” for treatment that physicians must follow to the letter, or risk their careers, life savings, and freedom from incarceration.

Lest you think DrRich is making this up, allow him to remind his readers of this excerpt, from the ominously-titled book, “New Rules,” co-authored by none other than Donald Berwick MD, who has run CMS for the past 18 months:

“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.”

Having thus terminated the classic doctor-patient relationship with extreme prejudice, the same political and medical leaders who conducted this assassination immediately realized they had to fill the void – for how can you have no such thing as the doctor-patient relationship? The solution to this problem, of course, was easy. Just as you can create a New Age medical ethics to fit modern exigencies, you can create a new doctor-patient relationship that will do the same thing.

So, what medical students are being taught today about the doctor-patient relationship has nothing to do with fiduciary responsibilities or ethical obligations. Rather, the New Age doctor-patient relationship is all about the interpersonal relationship between doctor and patient. Doctors are admonished: Be compassionate, be empathetic, be nice. And there’s nothing wrong with crying in front of your patients.

Not being an asshole, of course, has always been a useful trait for physicians. Doctors who can relate to their patients, displaying and actually feeling a certain amount of compassion and empathy, have always been more effective at communicating with their patients – and thus have been more effective physicians – than those who are arrogant, self-centered, aloof, or just plain mean*.

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*DrRich has already pointed out the following irony: many of the doctors who washed out of clinical medicine, possibly because they were too arrogant, self-centered, rigid, and/or aloof to be effective physicians, are now populating the expert panels which are writing the guidelines which will dictate the behavior of doctors who might otherwise be actually useful.
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The benefits of being a nice person are not exclusive to the medical profession. The same rules hold for anyone who makes his/her living by engaging in personal interactions with fellow humans. And so, until recent years, the medical profession categorized this fact (that doctors ought to have decent interpersonal skills) within the realm of common sense, common decency, and common knowledge – and the idea of the doctor-patient relationship meant something else entirely.

Every medical school now has formal training on the doctor-patient relationship, under which young physicians are taught to be compassionate, empathetic, and nice. To the extent that such traits can be taught – and DrRich has his doubts – there’s nothing inherently wrong with emphasizing interpersonal skills. There are, however, two problems that come to mind when emphasizing interpersonal skills becomes a substitute for emphasizing the real and true obligations of a professional.

First, teaching young doctors that a good doctor-patient relationship simply means being nice will result in newer generations of physicians having no concept of any fiduciary obligation to their individual patients. They will address the needs of the collective first, as a matter of course. (But as they withhold information on available treatments about which their patients are not to be informed, we can count on them to be extremely nice about it.)

Second, there is a growing school of thought, amongst those who are responsible for teaching this New Age doctor-patient relationship, that not only should doctors avoid stoicism at the bedside, but they also ought to openly display their emotions, so as to further reinforce their compassion, empathy, niceness, &c. By graphically displaying the deep empathy the physician has for his (or more likely, her) patients, he or she can really bond with them, and thus establish a really strong doctor-patient relationship.

And what better way to openly display one’s emotions than to cry?

Just as a general proposition, DrRich is against crying in front of patients. Certainly, there may be rare occasions when emotions rise up unexpectedly at the bedside – when a patient relates a particularly affecting personal story for instance. But in general, DrRich is convinced that doctors should not make a habit of expressing their emotions too frequently or too luxuriously to their patients.

Empathy and compassion are fine, but what sick patients really need is a doctor who can maintain some sense of composure even when things are the bleakest, some sense that, as bad as things are, this situation is not beyond the doctor’s experience. Even if the outcome is destined to be very bad, the patient deserves a doctor who acts like he or she has been there before, and who they can trust to remain at their side and help guide them through the ordeal that remains.

But DrRich is concerned that the faculty of our medical schools, who are busily training America’s Obamacare Doctors of Tomorrow, have reached the following epiphany: A particularly wonderful way to repair the failing doctor-patient relationship would be to indoctrinate young future physicians (most of whom these days, once again, are said to be women – not that there’s anything wrong with that) that crying at the bedside – indeed, openly displaying their every emotion at the bedside – is a marvelously therapeutic act. Such an open display of the doctor’s emotions conveys a powerful message to the patient, namely, “I care.”

Perhaps. But DrRich thinks crying at the bedside actually conveys two powerful messages to patients:

First Message: I empathize with you. I feel your pain.

Second Message: Your medical condition is so unbelievably dire that not even I can face it with any amount of composure. You, my friend, are well and truly screwed. I cannot imagine the agony you’re in for, without falling apart myself.  May God help you.

It is the conveyance of this latter message that, in the opinion of DrRich, ought to make most doctors on most occasions relatively circumspect about crying in front of their patients.

It is also this latter message that offers to make crying doctors a convenient tool for covert rationing.

When the doctor is reduced to tears (thus graphically demonstrating to the patient that the game’s about up; that there’s pretty much nothing, really, that’s going to change this bleak outcome; and how very sad it all is) – well! Talk about reducing your patient’s expectations!

A chief tenet of covert rationing is that patients who can be made to expect little will be satisfied with little. In most cases this is accomplished by simply coercing doctors to withhold from their patients all of their medical options. But if they can be encouraged to cry when delivering bad news, doctors can destroy patients’ expectations in a much more definitive fashion.

Furthermore, the traditional role of the doctor when a patient’s outlook is poor is to take charge of a very bad situation, and with great empathy, patience and fortitude attempt to guide the patient through that situation with as much skill and courage as possible, even if the final destination looks very bleak. If the doctor instead becomes just one more of the people who gather about the bedside crying about it, then the patient immediately perceives themselves to be abandoned and alone, placed into a position irremediably desolate, with no sense of direction, and no sense of control over their own destiny. Patients fighting illness from such a position do more than merely lose their expectations; they will also die much sooner and in greater despair than necessary.

So obviously, our modern healthcare system under Obamacare will see immediate advantages to encouraging emotional outbursts on the part of doctors. In the name of advancing empathetic physicians and fixing a broken doctor-patient relationship, we could, more easily and more often, get those folks who are in the infamous last six months of life to simply stop striving for a medical miracle – or even for non-miraculous but expensive therapies that actually exist, and that (alas!) might actually extend their survival – and thus effect the sick patient’s demise more quickly and more economically.

Certainly, now that medical schools are teaching forms of alternative medicine that in former years would have made real doctors blush, for courses on the doctor-patient relationship to encourage young doctors to let their emotions free is a good and natural fit.

Young doctors should not be taken in by such ploys. They should empathize with their patients, but remain strong, and lead their patients gently and resolutely through their medical ordeals. They should try to avoid allowing a free display of their emotions to break their patient’s spirit. Their job, instead, is to use their expertise to fortify their patient’s spirit, even in the worst of times. And above all they should not allow themselves to become the trained tools of an ultimately cynical healthcare system, that uses every ploy at its disposal to covertly ration medical care.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Theory A:

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

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

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

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

Theory B:

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

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

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

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

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

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

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

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

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

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

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

In a recent post, DrRich described the Regulatory Speed Trap, and alleged that our leaders (long before the Obama administration came along) have learned to use it to intimidate and control selected citizens and institutions when it is to their advantage to do so.

The Regulatory Speed Trap, readers will recall, involves the sudden and arbitrary “reinterpretation” of various confusing, ambiguous, or impracticable regulations which have been on the books for some time, and for which affected citizens and institutions (out of sheer necessity) have established de facto interpretations so that they can continue to function. By their longstanding acquiescence with these de facto interpretations, the Central Authority has at least tacitly endorsed them, and thus commerce is permitted to continue. Until, that is, the time arrives when it behooves the Central Authority to suddenly reinterpret those tangled regulations, and convert selected law-abiding citizens into criminals. By the selective enforcement of ambiguous laws, of course, the goals of Social Justice can be advanced.

As a public service, as a warning to academic medical centers, and as a heads-up to the Central Authority (which DrRich has found in personal encounters to be very scary, and to which he would very much like to endear himself against any future encounters) he will now describe a very serviceable but potentially forgotten Regulatory Speed Trap which was laid more than 15 years ago, and which is ripe for springing.

During the decade of the 1990s, DrRich was chairman of the Institutional Review Board (IRB) in a major teaching hospital. The IRB is the committee that reviews all proposed human research projects in the institution, and assures that the research meets ethical and legal standards as set forth by the Office of Human Research Protections (OHRP) of the HHS, and that the rights and welfare of the human research subjects are protected. The IRB has the duty and the authority to prevent or shut down any research project which is not meeting expected standards. The IRB, unlike any other committee within a hospital, reports directly to the Feds, in order to limit any local influence that may be brought to bear over its decisions by hospital administration, well-endowed researchers, or any other local big wigs.

If the Feds decide that an institution’s IRB is not assuring compliance with all the rules, regulations, guidelines, &c., in all their particulars, then they can arbitrarily and indefinitely terminate all human research in that institution, until such time that sufficient corrections, and sufficient penance, can be made – a process that is typically measured in years. This kind of research “death penalty” – which can ruin an academic institution – has been dealt out more than once.  The prospect is a dreadful one to any academic medical center.

It was, in fact, in his capacity as IRB chair that DrRich first became reasonably adept at reading and interpreting the kinds of obtuse regulations and guidelines commonly promulgated by our government. The official documents under which an IRB must operate are many, lengthy, and often difficult to interpret with absolute surety. Yet, in order for the IRB to function, these regulations and guidelines must be resolved into concrete meanings, which, under scrutiny, would most likely prove acceptable to the Feds. (A difficult task to be sure, but still, not markedly different from the task faced by anyone who wishes to conduct an activity for which the government has devised regulations.)

In any case, readers will understand why it was with some dismay that, in 1994, DrRich received this letter from the OHRP, announcing a new policy regarding diversity in human research.

Now to be sure, such a new policy was needed, since up to that time medical research evaluating new therapies was overwhelmingly performed on adult white males. However, this distribution of the benefits (and risks) of research was not in place because of prejudice against (or in favor of) women or non-whites. Rather, it was there for good and practical reasons. Ever since the thalidomide fiasco, it was verboten to enroll women who might become pregnant (i.e., any woman of childbearing age) in most kinds of clinical research. And African-Americans were understandably and appropriately distrustful of medical researchers ever since the Tuskegee study, and as a group they assiduously avoided participating in clinical research. So the exclusion of these groups was made, for the most part, either out of the desire to protect certain classes of individuals (such as unborn babies), or out of the desire of certain groups of individuals to protect themselves.

Still, DrRich was very sympathetic to efforts to find ways of safely extending research on new products to excluded groups. Otherwise, how could we learn if new medical products were safe and effective in everybody? So he read the letter from the OHRP with interest.

And he was immediately dismayed. While the government’s new policy of diversity in clinical research was advanced for the best of intentions,  the substance of the policy was impracticable past the point of absurdity.

The new policy on diversity in clinical research, in its essentials, stipulated:

1) All minorities and all genders MUST be included in all clinical research studies.
2) Sufficient numbers of subjects MUST be enrolled to allow valid outcome statistics to be performed for each category of participant.
3) Cost is NOT allowed as an acceptable reason not to enroll the stipulated groups in sufficient numbers.

The letter and its supporting documents defined six racial and ethnic categories that must be included: Hispanic or Latino, American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, or White.

The letter and its supporting documents defined the three genders that must be included as: Male, Female, Indeterminate or Transgender.

Because each defined subgroup must be included in each study in sufficient numbers to allow for valid outcome statistics to be computed, the new directive seemed to require each research trial to expand its size by 18-fold (to account for six racial/ethic categories, and three genders). So a study which would normally require the randomization of 1,000 patients to achieve statistical surety would now need to enroll 18,000 patients. Notably, the recruiting effort that would be needed to comply with this new policy would be far more than merely 18 times more difficult. For it is one thing to find an “extra” 17,000 people who are willing to risk their health for the sake of medical science, but quite another to find these altruists in just the right distribution, including, for instance, 1,000 indeterminately-sexed Pacific Islanders.

But no matter. The new policy explicitly stipulated that the expense of such a recruiting effort was not a permissible excuse for failing to enroll the proper distribution of subjects.

After carefully examining the letterhead of this document to make sure it did not come from The Onion, DrRich made some well-placed, but gentle and appropriately circumspect, inquiries in an attempt to determine whether he was reading it correctly. How seriously must one take this astounding new federal policy on diversity in research? He quickly learned he needed to stop asking questions. His sources revealed to him that several of the authorities in question actually considered their new directive to be a bit mild – a little too watered-down.

For instance, limiting the number of racial and ethnic categories to only six had been a major concession to practicality. Some of the interest groups that had been instrumental in constructing this new policy apparently had argued, for instance, that each of the 337 federally-recognized American Indian tribes ought to be called out as distinct groups. And the authors had thoughtfully compressed the number of genders to only three (when clearly there are at least four). So the people responsible for this new policy had already carefully considered the issue of practicality, and had mercifully compromised in order to render this policy as reasonable as the principles of research diversity would allow.

So yes, the Central Authority was deadly serious.

As it happened, at this very time DrRich was lodged in the teeth of another Regulatory Speed Trap (which he has described elsewhere), so he took this new OHRP policy very seriously. He knew that while it could not be complied with in all its detail, it also could not be ignored. So he called a special meeting of the IRB to discuss how to respond to the new policy.

A long meeting was held in which this new policy was introduced to the membership, and the members’ reactions were permitted to move through the necessary stages of mirth, horror, disbelief, resignation, and finally, resolution. When sober discussion was finally possible, the members unanimously agreed that encouraging the enrollment of women and minorities in clinical research was an important and laudable goal. We also agreed that if researchers were made to comply with the letter of this new policy, all clinical research in the U.S. would come to an immediate halt. And for this reason, we concluded, it must be true that the policy actually desired by the OHRP must be different from what appeared to be the letter of this policy.

We therefore composed a formal response to this policy, which we placed into the minutes of the meeting, for posterity, and for the benefit of whichever future government agents might burst through the doors with automatic weapons, in order to conduct unspecified investigations. That response went something like this:

Medical research aimed at reducing mortality and limiting pain and suffering is a great boon to mankind, and as long as it is conducted ethically it should be encouraged in every way. Diversity in research is also an important good, and to the extent it is practicable, individuals from all races and genders should be offered an opportunity to participate in clinical research. In deciding which of these laudable goals takes precedence, we note that while research can continue despite imperfect diversity, it will not continue if perfect diversity is an absolute requirement – in which case, one ends up with no research, and no diversity. Such a result, we hold, cannot possibly be the aim of the OHRP.  It therefore seems apparent to the committee that the intent of the diversity policy recently handed down by the OHRP must necessarily be to optimize diversity to the fullest extent practicable, and not to stifle research altogether in service to impossible diversity goals. We therefore interpret this new policy to indicate that all practical efforts must be made to recruit research subjects from all racial and ethnic groups, and from whichever genders we can find, and we will hold researchers in this institution to that policy.

And that’s just what we did.

Our formal interpretation of the OHRP’s diversity policy, it must be admitted, did not follow what certainly appears to be the letter of the policy. But it does work toward the stated intent of the policy, and it has the not-inconsiderable advantages of: a) being actually feasible to implement, and b) allowing medical research to continue. In general, DrRich has found that regulators are somewhat more inclined to look upon your behavior as being relatively benign, if you are able to demonstrate that you have taken their regulations seriously (no matter how absurd they might be) instead of simply disregarding them. Accordingly, our IRB created a record demonstrating that we explicitly acknowledged the new policy, we made a good-faith effort to interpret it in light of universally-recognized truths, and then we acted in accordance with that reasonable interpretation.

DrRich does not know how all the other IRBs in the U.S. responded to this new diversity policy. However, since no institution has stopped doing research on its account, and since no institution has launched massive programs to seek out the tens of thousands of transgender Alaskan Natives that would be required in order to conduct medical research under such a policy, one can only conclude that all those other IRBs also decided not to follow the new diversity policy to the letter. DrRich does not know how many of them took the trouble to make a formal record of their interpretation of that policy, and of their rationale justifying their subsequent behavior. In any case, by the studied inaction of the Central Authority, those interpretations have been allowed to stand for well over a decade, and medical research has proceeded accordingly.

DrRich left the practice of medicine – and the wonderful world of IRBs – at the turn of the millennium. He has no idea how big a deal the issue of “diversity in research” is these days. But to the best of his knowledge the OHRP policy has never been rescinded. Indeed, DrRich finds it extremely unlikely that, at any time during that interval, it would have been politically feasible for any government agency, under any Administration, to soften this or any existing formal policy on diversity.

Most likely, after 17 years, this Regulatory Speed Trap is still set, and waiting to be sprung.

As it happens, the Central Authority today is desperately looking for ways to stifle medical progress, since medical advances are among the chief drivers of increased medical spending. The 1994 diversity policy, whose clear-cut plain-English language is being so universally ignored by medical researchers in every American institution, would seem to offer a fine opportunity for shutting down some of that research.

This Regulatory Speed Trap is not only set and baited, but is swarming with potential victims. Fair warning.

While Grand Rounds is normally the highlight of everybody’s week here in the medical blogosphere, this time it’s different. This week, we are all – each and every one of us  – completely distracted by the most wonderful sense of expectation and joy, to the exclusion of virtually every other human emotion. For DrRich, at least, the feeling puts him in mind of the giddy anticipation he experienced on, say, his 5th Christmas eve, when he was still young enough to consider Santa Claus a magical-but-real agent of earthly delights. (This was before DrRich realized that Santa, being obese, is actually a great menace to society.)

For this, dear reader, is the week when President Obama will turn his considerable powers of intellect, at long last, to the issue of jobs. The President indicated to us more than a month ago that he would, in his own good time, present to us his program for fixing the horrific and prolonged unemployment problem which now affects most American families in some way. And thus realizing that a solution is finally at hand, we in the great unwashed masses have waited, as patiently as we could, through earthquakes, hurricanes, Martha’s Vinyard vacations, and numerous pre-season football games, for the President to tell us the Answer. And, summoning together a Joint Session of Congress – a venue most often reserved for declarations of war and similar life-altering policy initiatives, thus confirming the momentous nature of his coming words – he will finally proclaim to us the Good News, a mere two days from now. One can cut the anticipation with a knife.

So, while it is indeed an honor to be hosting Grand Rounds during this historic week. DrRich must admit to finding it a little difficult to concentrate his efforts. No doubt readers will likewise find it a challenge to turn their attention away from the Big Event long enough to peruse the following posts – the best of the medical blogosphere this week.

But be assured that there is good stuff to follow. So, if you find yourself incapable of focusing your attention on Grand Rounds at the moment, simply bookmark this page, and return to it once your sense of soaring happiness returns (as it inevitably must) to a more normal state. Be assured that this week’s entries are timeless enough to outlive your ecstasy (an emotion which – alas! – to be effective, must always be transient).

So let us begin.

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DrRich – having been informed not long ago, by an actual U.S. Attorney who at that moment had him under a form of official duress, that the DOJ is well aware of this blog and the general tenor of its content – always likes to mention early in any long post (so that his minders do not have to read the whole thing) any items that might be helpful to the Administration. Accordingly, we open Grand Rounds this week with the announcement, posted in The Examining Room of Dr. Charles, of the 2011 Charles Prize for Poetry. Dr. Charles has been hosting this prestigious contest – which seeks and awards excellence in poetry touching on health, science or medicine – for some time now, and it has proven to be an exceedingly popular annual event.

In addition to the significant intrinsic merits that accompany the Charles Prize for Poetry, DrRich must note that Dr. Charles is also awarding a not-inconsiderable cash prize to the winners. That is, he is creating what, in our present economic environment, must be considered damned-near jobs. Encouraging employment in the career of poetry is something, DrRich thinks, the President should seriously consider before Thursday night, lest he be tempted to make the huge mistake of attempting to whip up enthusiasm yet again for Green Jobs. (In the wake of the collapse just last week of the heavily-government-subsidized and heavily-Obama-promoted Solyndra Company, and of at least two other companies that received large federal funds for Green Jobs, treading that dead ground again would merely reveal that he is entirely bereft of ideas.) The Administration ought to thank DrRich, and especially Dr. Charles, for this critically important advice. Encouraging poesy, instead of Green Jobs, would demonstrate the kind of new thinking we are all looking for from our President at this critical juncture.

At Dr. Malpani’s Blog, Dr. M. outlines his 3-step approach for helping his patients understand the intricate concepts of in-vitro fertilization. First, you describe how the thing is supposed to work when everything is functioning normally (the “thing” in this case being the human reproductive system). Then, you describe to the patient where the system is breaking down in his/her case. And finally, you describe the options available for mitigating the breakdown. Dr. Malpani’s system, which he points out is generalizable, is aimed at creating a consensus for action when faced with a complex problem.

DrRich will only remark that Dr. M’s system, which works well enough for problems based in human physiology, is proving pretty worthless for problems based in the more social sciences, such as economics. This is because of a fundamental disagreement, among the debaters, on how the economy is “supposed to work when everything is functioning normally.” Progressives and conservatives have very different ideas about this. So Dr. M’s approach, which requires both logic and a fundamental consensus on what constitutes “normal” behavior, is unsuitable to non-physiologic systems.

Dr. Val at Better Health posts a recent interview with Dr. Dori Carlson, president of the American Optometric Association, regarding the importance of screening children for subtle but significant vision problems. (Dr. Val and Dr. Dori are referring here to the kinds of vision problems that involve optics, and not the kind suffered by our political leaders.) The type of gross vision screening which is conducted by most schools misses the majority of these vision problems in children, and those undetected vision problems not infrequently lead to impaired learning. Also, they often lead to misdiagnoses and inappropriate treatment, likely including the misdiagnosis of ADHD. (Missed vision problems constitute only one of the causes for the explosion in ADHD diagnoses in recent years. A more common cause, in our overly-feminized schools, is being a boy. Indeed, as nearly as DrRich can tell, being a boy today is a disease; they have drugs for it and everything.) In any case, if you are a parent of a school-aged child, you should strongly consider having your child’s vision checked by an ophthalmologist or optometrist – especially if somebody wants to put him on Ritalin.

Henry Stern at InsureBlog tells us the good news and bad news about a new study related to heart attacks. He notes that heart attack victims are receiving definitive therapy in American hospitals much more quickly than they were just a few years ago. And when you are having a heart attack, minutes count – the longer that coronary artery is occluded, the more permanent damage is done to your heart, and the higher your odds of death or disability. So the diminished delay to treatment is good news. As usual, though, there is bad news attached. DrRich, always the sunny optimist, does not wish to repeat the bad news. You can go to the InsureBlog to read it for yourself.

The ACP Internist reports a study showing that 80% of today’s doctors look up on-line information in front of their patients. DrRich, who admits to being an Old Fart, does not find this surprising, since young physicians these days are, well, young. And young people are on-line all of the time, reporting their every trivial thought and mundane action instantaneously to the Cloud. (If Andy Warhol were alive today he’d be talking about our 15 minutes of anonymity.) But you don’t have to be a young doctor to take up these new habits. It appears from this new survey that doctors of all age groups have ritualistically placed an LCD screen between themselves and their patients. In so doing, they have awarded to those distant, expert panels – the ones spinning out all those guidelines, pay-for-performance checklists, marching orders, &c – their appropriate and rightful physical position, that is, directly interposed between doctor and patient. This is more than mere symbolism, but the symbolism is delicious.

But, dear reader, please do not be too critical of today’s doctors. If you yourself were a savvy modern physician, realizing that you could go to jail if you do what you think is medically appropriate before checking with the Authorities to find out if it is also allowable, you’d have a computer screen in front of your face too, and you’d be looking stuff up in front of your patients the entire time they were blathering on about their symptoms or whatever. DrRich worries for the 20% of doctors (likely, his fellow Old Farts) who haven’t “gotten it” yet.

Beth Gainer at Calling the Shots makes an important observation about the two classic narratives to which all victims of breast cancer are assigned – the narrative of the triumphant hero, and the narrative of the courageous and noble victim. Ms. Gainer’s observation is that most women with breast cancer do not fit either of these prescribed narratives. Many women are thus left feeling guilty or diminished when they find that their experience is not meeting with society’s expectations. Ms. Gainer is absolutely correct, and indeed, her observation is generalizable. The same thing occurs whenever society’s designated narrative-makers assign a range of permissible attitudes, thoughts and behaviors to any defined group. Mercy on any member of the group who falls outside those designated norms.

David E. Williams at the venerable Health Business Blog addresses the question of how we – society – will cope with the next big trend in the drug industry – the development of “niche” drugs, drugs that are suitable for only a relatively small number of patients and which, therefore, are exceedingly expensive to develop and market. David goes directly to the real question – the problem of niche drugs makes the issue of healthcare rationing unavoidable.

So far, of course, we are doing our healthcare rationing covertly, and in the case of niche drugs that usually means interpreting clinical results in such a way as to minimize their potential benefits. We do this by saying that Drug X “only increases survival by 4 months,” and ignoring the fact that “4 months” is an average value, and that while many patients have no benefit at all, a non-negligible minority may live a lot longer. The question, “Is it worth $50,000 for only four more months of life?” is different from the question, “Is it worth $50,000 to have a realistic shot at living several extra years?” Covert rationing causes us to frame the question in such a way that the answer to any question beginning with “Is it worth. . .” is always, “no.”

At the Road to Hellth, Douglas Perednia, one of the best analysts of health policy writing today, looks at the rationale for the onerous penalties which are required under Obamacare for hospitals whose patients are readmitted at higher than the average readmission rates. Perednia describes the bogus math which the Feds are apparently using to determine what appropriate readmission rates ought to be – and points out the irony of requiring doctors to behave in an “evidence-based” fashion, while the Feds themselves are using frivolous statistics to dole out the equivalent of the NCAA Death Penalty to our hospitals.

Steven Seay, PhD discusses what ought to be second nature to any clinician – applying the principles of the scientific method to clinical practice. That is: gather the necessary data to formulate an hypothesis; institute therapy based on that hypothesis; measure the results of that therapy; revise the hypothesis to reflect this new data; repeat as necessary. This is the way clinical practice should be done. DrRich is happy to learn that it is still apparently OK for clinical psychologists to function in this manner. For physicians, especially PCPs, the scientific method has become forcibly compressed to: make a diagnosis; treat according to the guidelines. While the patient might not do so well with this new method, the physician will be OK, since “quality” will be measured according to one’s compliance with the guidelines. Measuring the actual results of the treatment, of course, would only lead to trouble, and in most cases will be avoided.

James Gault, MD, of the blog Retired Doc’s Thoughts, is a long-time champion of classical medical ethics (as opposed to the New Age medical ethics now formally espoused by all the major professional organizations).  As such, Dr. Gault often deconstructs arguments being published by modern medical ethicists supporting these New Age ethics, which require doctors to act for the benefit of the collective rather than for the benefit of their individual patients. In this post, Dr. Gault gives a very effective what-for to Professor Fuchs of Stanford, who, once again, has published a paper advancing the bankrupt argument that what’s good for the collective is necessarily good for the individual. These kinds of vapid arguments may fool the Whippersnappers, but they’re not fooling us Old Farts.

The ACP Hospitalist notes that, according to the Institute for Safe Medication Practices, a “grey market” is developing for life-saving medications that have been in severe short supply for the past few years. A grey market, DrRich thinks, is like a black market, but less illegal – though it is possible they are referring to Old Farts who are merchants. In any case, the ISMP says the grey market is price-gouging hospitals that need those important drugs, and have nowhere else to buy them. The solution, according to the ISMP, is (among other things) to empower the FDA to manage drug shortages and tighten regulations for drug distribution.

The growing, widespread shortage of important medications is indeed a bad problem. We should look for a solution to this problem. Shortages of any product occur when it costs companies more to make the product than they can get for it in the marketplace. Onerous regulatory policies by the FDA which, in the name of product safety, have greatly increased the cost of doing business for pharmaceutical companies, along with recent de facto price controls on generic drugs, have combined to make it economically unfeasible for drug companies to expend large resources to manufacture these drugs. It seems doubtful that piling on even more regulations will improve the situation. And attacking the grey markets will simply drive them further into the dark (since black markets are nature’s way of providing a product when governments act to limit it). Given the expected 500,000 pages of new regulations being conjured up out of the Obamacare legislation, drug shortages are merely the first of many critical medical shortages we will be seeing in the coming years. So it will be instructive to watch how our leaders handle this problem.

In any case, from the job-creation standpoint, DrRich believes there will be many employment opportunities in coming years in sundry black markets related to healthcare. Many skills will be needed, some of which should be quite exciting!

At the Prepared Patient Forum, Trudy Lieberman writes a post entitled “Health Insurance, Meet the Jolly Green Giant,” in which she discusses the new, patient-friendly labels that are supposed to accompany health insurance policies under Obamacare beginning no later than 2014. The labels sound like a good idea, but as Ms. Lieberman points out, there will be problems. For instance, for the Feds to mandate transparency in labeling is unlikely to be all that helpful when, at the same time, they often mandate utter secrecy on the part of providers (for instance, in creating severe anti-trust penalties for doctors who reveal the fees they have negotiated with insurance carriers). But as always, results are far less important than simply meaning well.

Sharp Incisions, a blog written by a self-described “fledgling” medical student, has sent in an affecting post about scrubbing in on a unique surgical case – the harvesting of six vital organs for transplantation from a patient who has been declared brain dead. DrRich prays that Dr. Incisions will maintain for a long time the same sense of wonder and gratitude, expressed in this post, for the gift of life.

A medical student who blogs anonymously at the D.O.ctor Blog, describes her first experience participating in cardiopulmonary resuscitation when it actually counted. DrRich, who in his days as a cardiac electrophysiologist ran hundreds of these things, and who became convinced over the years that three people was the optimal number to run a “code,” admits to being a little taken aback by this student’s description of the event, which sounds like it must have been as complex to coordinate as a Busby Berkeley production number. No wonder she was a little astonished by her experience. DrRich supposes that this must be the new-style CPR mandated by some new guideline or other, and would not be surprised to learn later this week that CPR procedures requiring 15 participants is part of the President’s new Jobs Plan.

Speaking of sudden death, one of DrRich’s recurrent themes here on the CRB is that sudden death is a great boon to our healthcare system (since not only is sudden death itself very cheap, but also it tends to remove individuals who would otherwise continue collecting Social Security, and who tend to have expensive chronic heart disease), and that therefore the government will tend to stifle the prevention of sudden death any time it can. Accordingly, Dr. Wes tells us that the Feds are about to further limit the use of the Zoll wearable defibrillator. Doctors have taken to using this device in high-risk patients during the first month or so after a heart attack, since guidelines specify that ICDs (implantable defibrillators) must not be implanted during this interval. Since sudden death is particularly likely during that first month, the Zoll device is being used as a “bridge to ICD.” Obviously, sudden death being the healthcare system’s friend, this must not be permitted. And so, Dr. Wes points out, soon it will not be.

At the HealthAGEnda Blog of the John A. Hartford Foundation, Marcus Escobedo describes how his father is coping with the decisions that need to be made as he deals with recurrent prostate cancer. Helping elderly patients deal with health issues is the thrust of Mr. Escobedo’s work at Hartford, and his new personal experience, he tells us, drives home the point. Specifically, Escobedo works to assure that elderly patients are considered to be more than just the sum of their disease and their age. DrRich is sorry to have to point out that no less an expert on American healthcare than President Obama has explicitly disagreed with this approach, and on national television to boot. Perhaps when he said this the President was suffering under the influence of teleprompterpenia, and perhaps if he had an opportunity to meet with Mr. Escobedo over a beer in the Rose Garden, he would possibly begin to revise his position to one that is more compatible with the mission of the Harford Foundation. On behalf of America’s Old Farts, DrRich would certainly hope so.

Dr. Thomas Pane writes in the Business, Surgery & Medicine Blog about tantrums, specifically, the kind occasionally thrown by surgeons in the operating suite. His post carries an important Labor Day lesson for anyone who hopes to make a career in the medical field in the coming years, so pay attention:

Everyone can agree that throwing tantrums in the operating room is never a good thing, and that quite often, it is a very bad thing. But Dr. Pane points out that, counterproductive as tantrums often are, they are nonetheless not the worst possible way in which a surgeon can express his/her utter frustration at a bureaucracy that blithely conspires to disrupt surgical procedures at critical moments. He reminds us, once again, that the biggest handicap one can ever have when working in an environment in which bureaucratic mud has fouled every gear is: giving a sh*t. So, while Dr. Pane may or may not agree, here’s the lesson: If surgeons would simply adopt the apathetic, indifferent attitude that classically characterizes long-term survivors in work environments mired by bureaucracy, all would be well.

Jaqueline writes Laika’s MedLiblog, a blog dedicated to medical information science. She submits a post entitled, “PubMed’s Higher Sensitivity than OVID MEDLINE… & other Published Clichés,” in which she shows how medical researchers doing literature searches for, among other things, meta-analyses, will stumble upon various “anomalies” in their searches of the PubMed and OVID databases, and then write additional, CV-padding papers about those anomalies. Jaqueline points out that these so-called “anomalies” are actually well-documented “clichés,” which are well-known to information specialists and anyone else who is competent in doing comprehensive literature searches. In other words, Jaqueline has documented that these meta-analysis researchers are rank amateurs at doing the most critical step in conducting meta-analyses – searching the literature for all the appropriate published studies. DrRich has always mistrusted meta-analyses, and Jaqueline has helpfully identified yet another reason to justify such mistrust. He thanks Jaqueline, and whoever planted those database anomalies which allow us to identify potentially incompetent meta-analysis researchers.

Nicholas Fogelson of Academic OB/GYN writes about taking care of the dying Jehovah’s Witness patient, or rather, taking care of the Jehovah’s Witness patient whose illness is potentially curable but who is dying because he or she refuses to accept blood products. DrRich can attest to how very difficult it is for a doctor to respect a patient’s religion when doing so results in their death. Dr. Fogelson’s description of his evolving attitude regarding this dilemma is compelling.

Need to be uplifted after reading the above post? Read Jordan Grumet’s submission from his blog, In My Humble Opinion. It’s brief and beautifully written, and it reminds us that sometimes our efforts as doctors – which all too often seem futile – can pay off in unimagined ways.

Pranab at the Scepticemia blog points to a news story about a medical school in Mumbai selling seats (that is, entry to medical school) to the highest bidder. He strongly objects to this practice, even though he postulates that his objection will make some of his readers call him “a leftist commie” (which DrRich finds to be the most common kind). DrRich does not agree with Pranab’s (tongue-in-cheek) conclusion that it is America’s fault that Mumbai medical schools are selling seats. (It is actually only George Bush’s fault.) But DrRich does agree entirely that the practice itself is an abomination. Indeed, we can all agree that entry to any career which requires a high degree of skill, talent, and/or intelligence ought to depend on merit, and nothing but merit. Can we not? Good.

____

DrRich will end by noting that he is finishing this Jobs! Jobs! Jobs! Edition of Grand Rounds during the waning moments of Labor Day, which causes him to fondly recall those long-ago days of yesteryear, when the U.S. still had plenty of steel mills and DrRich was a card-carrying member of the United Steelworkers of America, and the thought of attending medical school had not yet penetrated his still-empty head. And he recalls how, while he was working one day as a lowly laborer, a union boss came over to him to explain (after DrRich had complained about it) the utility of his spending three painful days moving a large pile of slag, employing only shovel-and-wheelbarrow technology, from one location to another – AND THEN BACK AGAIN.  Now, those were the days when we knew how to make jobs!

Say, whatever happened to those steel mills, anyway?

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.

In his last post, DrRich pointed out to his PCP friends that their chosen profession of primary care medicine is dead and buried – with an official obituary and everything – and that it is pointless for PCPs to waste their time worrying about “secret shoppers” and other petty annoyances.

It is time for you PCPs to abandon “primary care” altogether. It is time to move on.

Walking away from primary care should not be a loss, because actually, primary care has long since abandoned you. Whatever “primary care” may have once been, it has now been reduced to strict adherence to “guidelines,” 7.5 minutes per patient “encounter,” placing chits on various “Pay for Performance” checklists, striving to induce high-and-mighty healthcare bureaucrats (who wouldn’t know a sphygmomanometer from a sphincter) to smile benignly at your humble compliance with their dictates, and most recently, competing for business with nurses.

This is not really primary care medicine. It’s not medicine at all. It’s something else. But whatever it is, it’s what has now been designated by law as “primary care,” and anyone the government unleashes to do it (whether doctors, nurses, or high-school graduates with a checklist of questions) now are all officially Primary Care Practitioners.

What generalist physicians (heretofore known as primary care physicians) need to realize is that “primary care” has been dumbed-down to the point where abandoning it is no loss; indeed, it ought to be liberating to walk away from it.

The beauty is that to survive and flourish, you don’t really need to change your medical ideals or even your medical behavior (unless, of course, you have bought in to the strict adherence to guidelines, checklists, &c.) You simply need to practice medicine exactly as you were trained to practice it – taking all the time needed for careful, thoughtful attention to detail; seeking out the meaningful nuances in your patients’ medical conditions; personalizing both diagnostic and therapeutic recommendations not only for your patient’s medical problems, but also for their psychosocial and economic circumstances; relishing the challenge of making the difficult diagnoses, and managing the complex medical disorders that so often break from the designated norm; and treating guidelines as just that, as often-helpful guideposts, rather than mandates; and most important of all, embracing the classic doctor-patient relationship in all its particulars, and having the latitude to become a true advocate for your individual patients within a hostile healthcare system. In short, you can go back to being a real doctor, and not a cipher in some bureaucrat’s database.

There are only two things you need to do to move in this direction.

First, abandon the “primary care” label. Remember, primary care is now the standards-based, checklist-driven, one-size-fits all, “high-quality” system of practice imposed by government bureaucrats, a practice which is now open to both doctors and nurses (and, in the future, most likely to others).  That’s not what you do. So find a new name for yourself.

The choice of nomenclature is yours, of course, but DrRich humbly suggests “Advanced Care Medicine.”

What you do is not primary care; it’s far more advanced than that, and nobody could do it without the sort of extensive training you have. “Advanced Care Medicine” captures that notion. This name also opens the possibility of referrals from the new-style, government-sanctioned “PCPs,” some of whom undoubtedly will come to recognize that at least 20% of their patients will present as clinical puzzles that do not fit very well with any of the standard medical diagnoses with which they are familiar, and another 20% will not respond to the recommended therapy as the guidelines say they must. These patients obviously will need advanced management, management beyond what a modern primary care practitioner is able (or allowed) to offer. Why not refer them to an ACM physician?

Second, you need to establish practices whereby you are paid directly by your patients. You need to do this because it is the only method available for avoiding the bureaucratic nightmare that wrecked your former profession of primary care in the first place. Payment models can be established that will allow most patients – anyone, say, who can afford a cell phone contract or cable TV – to participate.  (Making your services readily available will blunt the obligatory attacks of “elitist!” which will be aimed your way in the attempt to shame you back into the primary care gulag). There really ought to be nothing particularly revolutionary about this kind of practice, since it was the norm throughout most of the history of medicine until 40 years ago. It is likely that many patients who today would never consider paying any doctor out of pocket will eventually change their minds, once it becomes apparent to them the depths to which primary care medicine has fallen in the United States, and that as a result their lives are on the line.

In any case, when you are paid by your patients, you answer to your patients (not some hostile bureaucrat), and the quality of the care you deliver is measured by your patients (and not some other hostile bureaucrat).  There are no externally imposed time-limits to your office visits, no checklists you must complete, no bizarre documentation rules you must follow for reimbursement, no guidelines you must obey even if it makes no sense for your patient. Those things are for the modern, government-approved “PCPs” to concern themselves with, poor souls, and you do not dwell among these unfortunates anymore.

And happy it is that primary care medicine is killed off now, at this time – because time is of the essence. DrRich has already pointed out that an essential feature of our new Progressive healthcare system will be to make it illegal (in the name of fairness) for individuals to spend their own money on their own healthcare. For Advanced Care Medicine (or whatever you may choose to call it) to become a viable path, you’ve got to begin immediately to make it a fait accompli – to establish it as something patients value, and which they fully expect as a personal healthcare option, and furthermore, as an indispensable referral resource for those sad souls – physicians, nurses and others – who retain the label “PCP,” and who will be powerless (if not clueless) when it comes to providing complex medical care to patients who come in with a difficult diagnosis, or more than one diagnosis, or who otherwise display guideline-unfriendliness.

So at the end of the day, the fact that Obamacare has formally brought primary care medicine to a merciful end may turn out to be a positive thing.

And by all means, don’t sweat President Obama’s “secret shoppers,” or any other cutesy ploys which our policy experts may dream up in the future to amuse themselves, and to distract you from the real issue (which is the demise of your profession). When those phony secret shoppers call for a phony appointment, simply tell them you have openings for any patient, at very reasonable rates and at at a time of their choosing, and that they can see a real doctor who will treat them with dignity, care, expertise, and respect. Or on the other hand, you can remind them, they can take their chances with one of those embittered or indifferent, underutilized or under-trained, oppressively over-regulated or complaisantly submissive, new-style PCPs specified under Obamacare.

Even Obama’s secret shoppers would have to think twice about a choice like that.

The recent announcement that President Obama would dispatch “secret shoppers” – agents of the government posing as patients with either private insurance or Medicare/Medicaid, who would call primary care physicians’ offices to document how long it takes to receive appointments – had many PCPs quite upset.

PCPs were upset despite the fact that the administration assured them that the President’s spies were only aiming to help. In particular, the secret shoppers were going to document that America has a PCP shortage, presumably so that government programs of some sort could be devised to fix that shortage. (They would also document, bye the bye, that patients with government insurance have a more difficult time getting appointments with PCPs.) Apparently, however, the outcry from insulted PCPs was so great that the administration quickly decided to scrap the secret shoppers program – for now, at least.

It is obvious that what the administration claimed they wanted to measure is already well known. Yes, there is indeed a PCP shortage. And yes, PCPs (being, on average, intelligent persons) are relatively slow to schedule patients whose insurance is known to result in a financial loss – if they schedule them at all.

Therefore, equally obviously, there must be some other motive for the administration to have devised this secret shopper program.

The real motive, DrRich submits, was to establish with actual data that: a) we have a two-tiered healthcare system, in which patients on government insurance plans sometimes have more difficulty obtaining medical care, and b) doctors (even the universally-beloved PCPs) are greedy and untrustworthy. Such results, with expert handling, would have served to move some American citizens a little closer to accepting a single-payer healthcare system. It would also serve to convince a few people that, seeing as how physicians behave so badly, perhaps it is not really necessary to have a doctor as your PCP.

All in all, the secret shopper program would have been a few hundred thousand dollars well-spent.

Still, DrRich can only shake his head in wonderment that his PCP friends expressed such great dismay over such a small thing as the secret shopper program. It is as if, after the Titanic struck the iceberg, a delegation of passengers was dispatched to berate the Captain because the turn-down service seemed slow that night.

How is it possible for PCPs to be so indignant about such a trivial thing as secret shoppers, when the very means of their livelihood – their chosen career – is at an end? For it is plain to anyone who cares to look that primary care medicine as we know it is dead. It lingered for years in a moribund condition, and its obituary was finally published last year in the Obamacare legislation.

Primary care’s cause of death was a culmination of two fatal disorders. Firstly, the healthcare system itself – well before the Obama administration came along – slowly smothered primary care into oblivion.

Consider the reduced condition to which the healthcare system – especially the government payers – eventually drove the primary care doctor: Their pay is determined arbitrarily by Acts of Congress, like workers in the old Soviet collectives. They are directed to “practice medicine” strictly according to directives (quaintly called “guidelines”), handed down from on high by panels of sanctioned experts, and accordingly PCPs are enjoined from taking into account their professional experience, or their specific knowledge of their individual patients. They are limited to 7.5 minutes per patient “encounter,” and the content of this brief encounter is determined by sundry Pay for Performance checklists, so as to strictly limit any interactions with their patients that do not meet the approved agenda. Their every move must be carefully documented according to incomprehensible rules, on innumerable forms and documents, that confound patient care but that greatly further the convenience of the stone-witted bureaucrats who are employed specifically to second-guess every clinical decision and every action they take. Worst of all PCPs have been charged with being the primary mediators of covert, bedside healthcare rationing, and to this end have been pressed to nullify the classic doctor-patient relationship by the healthcare bureaucracy that determines their professional viability, by the United States Supreme Court*, and by the bankrupt, new-age ethical precepts of their own profession.

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*Pegram et al. vs Herdrich(98-1940), 530 US211 (2000)
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By such insults, even before Obamacare became the law of the land, primary care medicine had been reduced to one of the most frustrating, enervating and demeaning endeavors a physician could imagine.  Many if not most practicing PCPs are looking to either retire early or change careers, and medical students – even the most idealistic ones – are avoiding primary care in droves, especially if their training exposes them to the palpable despair radiated by actual primary care physicians.

But the second fatal disorder has nothing to do with policy or politics. Even if doctors had perfect control of the healthcare system and the political realities, primary care medicine (as we know it) would still be in trouble. This is because of an axiomatic truth revealed by the annals of human progress, to wit: As knowledge increases and technology improves, activities that used to require the services of highly-trained experts become available to non-experts who have much less training. A lot of what PCPs have traditionally done – check-ups of well patients, screening for occult disease, controlling cholesterol, advising on diet, weight loss and exercise, managing routine hypertension and diabetes – really can be reduced to a series of guidelines and checklists, which can be adequately followed by individuals with much less training than these doctors receive.

When any area of expertise evolves to this level, it is inevitable (in a free economy) that lesser-trained individuals will inherit it. This event greatly increases productivity, makes the services in question more readily available to many people at lower cost, and (ideally) frees up the experts to take on more challenging endeavors. While this kind of transition is nearly inevitable, it is often painful and disruptive. The pain and disruption are being experienced by PCPs today.

DrRich agrees with fellow blogger Wade Kartchner that primary care medicine has advanced to the point where it really would make sense to turn over many of the routine, mundane, and reducible-to-checklist tasks that PCPs typically perform to non-physicians. PCPs who are fighting against this inevitability are wasting their time and energy. They are fighting both history and the laws of economics, so in the end it is a losing battle. It is time for PCPs to move on.

It is of course immaterial whether you agree with DrRich on this point. It is immaterial because this is how the Central Authority sees it.

Having painstakingly reduced you PCPs to tools of the state – whose chief job is to follow the guidelines and place chits on the checklists, &c. – it is only natural for the Central Authority to eventually notice that you really don’t need all that training to do the kind of job they have invented for you. Nurses – who can be “trained up” much more rapidly than you, who will work for much less money than you, and who (they think) will be much less recalcitrant about following handed-down directives than you – will fill the gap. And you, doctor, can go pound salt.

So it was really only a formality for the Obamacare legislation to make the death of primary care official. And the new law, accordingly, did so by stating explicitly that PCPs and nurse practitioners are now equivalent, one and the same. They are both PCPs under the eyes of the law. The actual language of the obituary is as follows:

The term ‘primary care practitioner’ means an individual who —

(I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or

(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in 9 section 1861(aa)(5))

What this means is that today there are two pathways to becoming a PCP. You can spend four years in college, four years in medical school and three years in a clinical residency – or you can go to nursing school and do another year or two of clinical training. Given this established fact, one could hardly fault patients for questioning the common sense (if not the intelligence) of a healthcare worker who, at this point in the history of medicine, would choose the former pathway.

And so the issue is decided. PCPs: by virtue of your specialty you have been formally (and legally) reduced to the status of a nurse-equivalent. Your specialty, as you have known it, is dead.

Among other things, this means that the secret shopper gambit – when it is finally implemented – is just not worth worrying about. It’s only a way to convince a few more Americans that their PCPs are essentially worthless, and that they’d be just as well off having a nurse practitioner do the job. So don’t sweat the secret shoppers. Forget them.

Instead, you need to decide what you’re going to do about the demise of your chosen career.

In his next post, DrRich offers you some friendly advice in this regard.

In an article appearing last week in the American Heart Journal, investigators concluded that if American doctors would prescribe for their patients with heart failure each of the six therapies which are most strongly recommended in current heart failure guidelines, 68,000 lives per year could be saved.

The following (for the interest of the reader, and for the convenience of any attorneys who may follow DrRich’s offerings), is an ordered list of these six proven, life-saving heart failure therapies, along with the number of American lives that could be saved each year if only American doctors would stop grossly under-utilizing them in violation of published guidelines:

• aldosterone antagonist therapy – 21,407 lives
• beta blockers – 12,922 lives
• implantable defibrillators (ICDs) – 12,179 lives
• cardiac resynchronization therapy (CRT) – 8317 lives
• hydralazine plus isosorbide – 6655 lives
• ACE inhibitors or angiotensin receptor blockers (ARBs) – 6516 lives

The authors, of course, are careful to point out that their analysis is based on statistical methods, and thus must be counted as merely estimates of the magnitude of the benefit that would actually occur should American doctors suddenly begin managing their heart failure patients appropriately. (Their presentation of these estimates to five significant figures implies a level of precision far in excess of what can be justified, and therefore must be an oversight not only by the authors, but also by the reviewers and the editors. But still, one gets the idea. A lot of preventable deaths are being left on the table.)

Several studies have reported, over and over again, that fewer than half of American patients with heart failure are receiving all the treatments available to them that have been shown to reduce symptoms and/or prolong life. Indeed, DrRich, on his patient-oriented heart disease website at About.com, has long urged patients with heart failure to familiarize themselves with all the recommended therapies for their condition, so that when they are with their doctors at least somebody in the room will bring it up.

(Such advice, DrRich reminds his readers – all of whom are likely to be patients one day – ought to be considered generalizable for all American patients with all medical conditions, in an era when doctors are being coerced to ration healthcare at the bedside by omitting mention of sundry available medical services.)

But DrRich’s purpose here is not to address those unfortunate heart failure patients whose lives are being jeopardized by their physicians’ acts of omission. but rather, is to strategize with his colleagues who treat heart failure patients as to how they should respond to this embarrassing revelation that by failing to follow published guidelines, they are killing so very many patients.

After all, only a few months ago, when another research study showed that 23% of ICDs were being implanted outside of published guidelines (even though the large majority of those “inappropriate” implants turned out to be actually indicated, but were performed within a 40-day waiting period that the guidelines specified), not only was this violation played up on the evening news and splashed across newspaper headlines, but also the Department of Justice immediately launched an investigation to determine whether it could bring criminal charges against implanting physicians. That is, failing to follow recommended guidelines to the letter is now not merely suboptimal medical practice, but also criminal behavior.

And how much worse than implanting indicated ICDs a few days earlier than the government would prefer, is behavior that causes the unnecessary deaths of 68,000 people a year? It seems to DrRich to be quite a bit worse.

So should American doctors who treat patients with heart failure be feeding their Swiss bank accounts, changing their identities, and stocking their lean-tos in the Montana backcountry?

DrRich brings good tidings – there is no need for you to overreact. The Feds cannot possibly prosecute all deviations from all clinical guidelines. Not only would that be unfeasible, it would also be counterproductive. And deviations from the heart failure guidelines are just the kind of deviations from which the Feds are inclined to look the other way.

We must remember that the primary directive of the American healthcare system, whether it is run by insurance companies or the government, is to ration healthcare covertly. Covert rationing means withholding whatever medical services you can, from whatever patients you can, whenever you think you can get away with it. If one remembers this simple rule, one can accurately predict the response of the health insurance companies or the government to any particular guideline violation.

So: When doctors implant expensive ICDs outside of the guidelines, even when the deviation is to place an indicated ICD a few days earlier than specified, it is a potentially criminal offense. Those ICDs cost a lot of money, and worse, prevent inexpensive sudden deaths, so it is clear that steps need to be taken to prevent their usage. Enforcing the guidelines to the letter therefore is imperative.

On the other hand, when deviations of guidelines result in NOT spending money (say, on drugs, ICDs, and CRT devices), those deviations will  be viewed quite differently. And when those same guideline deviations result in the premature deaths of tens of thousands of patients with chronic and expensive medical conditions (and who, had they survived for another five or 10 years, would have consumed lots and lots of extra healthcare dollars and, in most cases, Social Security payments), the last thing you would want to do is to engage in guideline-enforcement activities.

If you doubt DrRich on this point, ask yourself whether you’ve been treated to news stories over the past 10 days on how American doctors are killing 68,000 people each year by failing to follow guidelines. That story, it seems to DrRich, would be much sexier than the one that made a splash in January about ICDs being implanted too early. Yet we’ve heard next to nothing about it. These are not the kinds of guidelines violations we need to put a stop to. These guidelines violations do not fit the narrative.

Also, consider the editorial that accompanied the article in the American Heart Journal last week. It constitutes a strong apologist argument for violating the heart failure guidelines. It points out, rightly, that perhaps there were good reasons that some patients with heart failure do not receive all six of the recommended therapies, and that not all guidelines are applicable to all patients. It also points out that the number 68,000 was estimated by compounding several assumptions together, which would place large error bars around that estimate. So perhaps the guidelines deviations were not as lethal as the authors estimated. But most striking of all, the editorialist argues that it would just be too expensive to follow the guidelines for all patients with heart failure.  If ICDs were used in all patients for whom the guidelines say they should be used, for instance, this alone “would divert most of the money anticipated for all heart-failure care next year to these devices.”

The editorial is correct, and it is honest. It, at least, openly acknowledges that doctors are obligated to ration healthcare, based on costs, at the bedside, and that following these guidelines would violate the imperative to ration. Current guidelines on heart failure would cost a lot of money up front, and would result in the prolonged survival of a lot of very expensive Americans. And therefore, doctors will not be held accountable for failing to follow them.

American doctors can continue deviating from the heart failure guidelines, secure in the knowledge that their activity (or inactivity) will not capture unwanted attention from the Feds. These are not the guidelines our leaders are talking about when they assure the population that they are going to make sure that doctors are doing all the things the experts specify they should be doing.

These are those other kinds of guidelines.

If you are an American patient with any kind of medical problem whatsoever, DrRich begs you to become an expert in your medical condition. The patients with heart failure who are doing so, and who are prepared to challenge their doctors on their treatment, are among the minority who are receiving all the therapies proven to prolong their survival.

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.

Q. What is the difference between a public health expert and Il Duce?
A. Mussolini was not nearly as arrogant as a public health expert.

In prior posts, DrRich related how two major publc health efforts over the past few decades – the effort to put all of us on low-fat diets, and the effort to reduce everyone’s cholesterol levels – have amounted to massive experiments, based upon insufficiently-tested assumptions and surmises and hypotheses which the experts arrogantly (and incorrectly) determined to be fact, and which were conducted upon the entire American population without its knowledge or consent.

These public health experiments cost billions of dollars, needlessly transformed large swatches of American industry, and (at least in the case of low-fat diets) likely produced significant harm to the citizenry. Furthermore, despite such results, these misbegotten public health efforts have inured Americans to the notion that it is right and proper for government experts to determine for each of us what we must and must not eat.

DrRich now feels obligated to call his readers’ attention to yet another experiment which these same public health experts have launched, an experiment under which each of us – once again – is to become an unwitting research subject, an experiment whose results are unpredictable, but which has a realistic chance of producing harm to many of us. DrRich speaks, of course, of the new US dietary guidelines, published earlier this year, regarding sodium.

Those new guidelines begin with these established “facts:” Sodium is bad. We all get too much of it. And if we restricted our salt intake to a much lower amount than we are likely getting today, we will all become healthier and live longer. Relying on this received wisdom, the new guidelines call for us to cut back to 2300 mg of sodium per day – unless we are 51 or older, or African-American, or hypertensive (and most Americans fall into one of these three categories), in which case we are to restrict our sodium to 1500 mg per day.

For anyone who strays from eating only fresh fruits and vegetables, this kind of restriction is likely to prove a challenge. A nice bowl of dry cereal, for instance, even before you add milk, may give you up to 1000 mg of sodium.

Some Americans might consider such severe restrictions to be merely a statement of an ideal – a goal that, while laudatory, is entirely unreasonable or impracticable, one which we ought not expect to achieve with any degree of perfection, across a large population, in real life. But DrRich assures his readers that this is not at all how the Feds are viewing the matter.

The Institute of Medicine, for instance, is all over it. The IOM recently published (in conjunction with the new Guidelines) its “Strategies To Reduce Sodium Intake In the US.” Noting that public health experts have tried in vain for decades to get Americans to cut back on salt, the IOM says the time for persuasion by education has passed. The great unwashed are proved to be recalcitrant, yet again, to reason and science. It’s time to take the gloves off. So the IOM calls for the US government (specifically, the FDA) to use its regulatory firepower to enforce – once and for all – the kind of sodium restriction that the public welfare demands.

Specifically, the IOM calls for the FDA to reclassify “salt” from a food ingredient categorized as GRAS (“generally regarded as safe,” i.e., items which have been used for millennia in food preparation without regulatory oversight, such as pepper, parsley, or vinegar, and which are accepted as being harmless), to a “food additive” (i.e., a substance which is certifiably harmful, and for which strict, enforceable rules must be promulgated regarding its use). Re-classifying salt as a food additive will give the FDA the authority it needs to enforce its usage (as with any other regulated substance) in the food processing industry, in restaurants, and even, one must assume, in the home. With this new designation, the FDA (and other government agencies) will be able to deploy whatever regulatory and enforcement muscle they must, in order to assure that the Guidelines for sodium are at last realized.

This is serious stuff. The government at last seems dedicated, as never before, to actually implementing a significant sodium restriction for all of us within the teeming masses. All, of course, for our own good.

You might think, if you have not been paying attention, that in order for the Feds to launch into such a concerted, sustained, and widespread public health effort, the scientific data to support such an action must be pretty airtight. But if you have been paying attention, you will not be surprised to hear that the actual advisability of restricting dietary sodium across the entire population is anything but settled. In fact, it remains very controversial among scientists.*

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*DrRich stresses here that this discussion refers only to sodium restriction applied across the population. Sodium restriction for at least some people who already have hypertension – or a few other medical conditions such as heart failure and some types of liver and kidney disease – is well-established as being beneficial.
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There are at least three outstanding questions regarding the advisability of a general policy enforcing salt restriction. Until these questions are addressed, the implementation of a generalized and severe sodium restriction across the population seems to DrRich to be quite ill-advised (and, of course, incredibly arrogant).

1) Does Sodium Restriction Really Do Any Good?

DrRich could write several very long posts addressing just this one question. Instead, he will simply summarize the problem.

The question hinges on the relationship of salt intake to blood pressure – that is, does higher salt intake cause the blood pressure to increase? This turns out to be a difficult question to answer with any scientific precision. The studies are difficult to conduct, and difficult to interpret. Accurately measuring sodium intake in any sizeable population of patients is nearly impossible; and even measuring blood pressure (which varies tremendously from minute to minute, depending on activity, stress, and many other factors) in a reproducible way within a population of patients is difficult.

Scores of studies have been conducted to try to address this question. And one can assemble from these studies a large group which will show that salt intake correlates nicely with blood pressure. On the other hand, one can also assemble from these studies a large group that shows it does not. And for decades, the salt vs. blood pressure question has been divided into two camps, each of which have major conflicts of interest*, and which cite only those studies which tend to support their point of view.

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* In one camp are the National Heart, Lung, and Blood Institute, the National High Blood Pressure Education Program, the Institute of Medicine, and academic experts on hypertension whose careers have been based on funding from these organizations, and whose reputations and academic standing rely on sodium intake being a major determinant of blood pressure and health.  In the other camp are the Salt Institute, the big manufacturers of processed foods, and sundry academic experts on hypertension whose careers have enjoyed funding from these sources.  Take your pick.
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To see just how deeply politics is involved in the salt controversy, DrRich highly recommends this article by Gary Taubes, which appeared several years ago in Science, outlining the machinations that have been employed by the various parties in interpreting some of the complex studies that have attempted to correlate salt intake with blood pressure.

DrRich is convinced that, at the very least, this is not a settled question.

But even if it were a settled question, and sodium intake did indeed correlate nicely with blood pressure across the whole population (which, at a minimum,  would be a necessary conclusion in order to legitimately enforce a sodium restriction across the whole population), the degree of blood pressure reduction that even sodium-restriction-enthusiasts predict, even employing very significant salt restrictions, seems trivial – most experts predict an reduction in blood pressure of only 1-2 mmHg.  Assertions that public health experts often make to defend their sodium restriction guidelines, to the effect that this kind of tiny reduction in blood pressure on a worldwide basis would save over 100,000 lives per year, is (scientifically speaking) hogwash. Such estimates are calculated from strings of assumptions piled upon assumptions, and have little or no bearing on reality.

The fact is that we just don’t know what effect it would have on the population’s health to significantly restrict salt intake in everybody. We don’t know either the magnitude of blood pressure reduction it would achieve, or the improvement in clinical outcomes that would follow such blood pressure reduction.

We could find out if we really wanted to – by doing a large, randomized clinical trial to test the hypothesis. But the public health experts have determined that such a randomized trial is not necessary (the issue being “settled”), and not desirable (time being of the essence).

They would rather conduct a non-randomized experiment that enrolls every living American as an unwitting research subject. Then, in a couple of decades (reminiscent of the low-fat diet “experiment”), maybe we could figure out how it all worked out.

2) Does Sodium Restriction Cause Harm?

Here is a question that the public health experts, who consider salt restriction to be an unalloyed good, really object to. They tend to get downright nasty when anyone brings it up.

But, as it happens, it is a legitimate question.

Sodium is an extremely critical substance in any living creature. For any living cell to function normally, it must exist in an environment that contains, within a narrow range, just the right concentration of sodium. Consequently, living beings have evolved a complex series of mechanisms to assure an adequate sodium concentration under any and all circumstances. So, if animals are made to survive on a severely sodium-restricted diet, these homeostatic mechanisms are called into play to severely restrict the loss of sodium from the body. Such mechanisms can have many secondary effects.

In states of sodium depletion, tissues are more susceptible to injury from ischemia (lack of oxygen), a condition seen in heart attacks and strokes. Kidney damage caused by many types of medication will occur much more readily in states of sodium depletion. The way the kidneys handle various drugs is also altered when sodium intake is reduced, leading to potentially harmful changes in the blood concentrations of certain medications. The renin-aldosterone system is activated under salt restriction, which can have several adverse effects. (In fact, a major therapy for several medical conditions, such as heart failure and – ironically – hypertension, centers around suppressing the renin-aldosterone system.) Adrenaline levels and LDL cholesterol are increased when sodium is restricted. And at least one study, disturbingly, has correlated sodium restriction with an increase in cardiovascular mortality.

Calling attention to these kinds of findings just makes the sodium-restriction camp angry, and they usually respond by pointing out that so-and-so got a grant from the Salt Institute. (DrRich agrees that there are conflicts of interest, but those conflicts are flagrant on both sides.)

The fact is that the scores of observational trials that have been conducted do not allow anyone to reach a definitive conclusion about the advisability – regarding either its efficacy or its safety – of salt restriction across the population. An objective observer, operating on established scientific principles, would have to say that the only action that makes any sense at this point would be to conduct that large, randomized clinical trial, using actual clinical outcomes as an endpoint. Only such a trial can begin to sort out the discrepancies, and has any chance of allowing us to resolve the differences (by any means other than by fiat).

The public health experts, however, hold the high ground. That is, they control the “opinion” of the various health-related agencies wielded by the Central Authority. And they fail to recognize any discrepancies whatsoever. For them, the issue is settled, and it is past time to sweep aside any opposition, and implement the plan. Proponents of salt restriction have the will and they have the authority, and accordingly they have determined: Just do it.

3) Is It Even Possible To Change Sodium Intake By Public Policy?

Again, maintaining the proper sodium concentration in tissues is critical to life, so living creatures have evolved a complexity of mechanisms to assure that the concentration of sodium remains within the proper range.

Among these, it now appears, is an inherent “sodium appetite” enjoyed by all humans and all animals, an in-born mechanism that holds the body’s sodium content to a certain set-point, and determines how much sodium an individual will ingest each day to keep to that set-point. This set-point is maintained by a complex neural network involving several centers within the central nervous system, as well as inputs from the peripheral tissues. One’s physiology regulates one’s sodium intake to satisfy the body’s needs.

Furthermore, studies of sodium intake across a wide array of human populations, living under a wide variety of conditions and dietary constraints, also show that the range of salt consumption humans take in to achieve their set-point is remarkably universal, and is maintained within a fairly narrow range. That is, not only do humans consume the proper amount of sodium as determined by the body’s needs, but across the diversity of humanity that “automatic” sodium intake is maintained within a remarkably fixed range. (Sodium intake moves within that range to maintain the body’s proper sodium set-point.)

As it happens, the lower limit of that universal, naturally occurring, “optimal” range of sodium intake is roughly 2300 mg/day.

Astoundingly, this natural lower limit, determined by our physiology, is the same as the the upper limit our government would have many Americans consume. And our natural lower limit is far higher than the 1500 mg/day upper limit our government will be enforcing for more than half of us.

In other words, by decree, our government would have every American consume an amount of sodium that is below the optimal range as determined by human physiology. Almost by definition, anyone living under the recommended guidelines would likely be unable to maintain proper sodium concentrations through sodium intake alone, and would need to recruit the secondary, sodium-retaining, potentially-harmful physiological mechanisms (such as the renin-aldosterone system) to keep sodium concentrations at an adequate level.

In any case, it is apparent that even if a universally-applied policy of significant sodium restriction was proved to be safe and effective, it is not at all clear that it is possible to make people comply with such a restriction. This kind of restriction will be fighting our inherent “sodium appetite” regulator that has been forged through millions of years of evolution. This kind of restriction would appear to fly in the face of our human physiology.

We need salt, dear readers, we truly do. The only reason the Founders did not include an additional paragraph in the Second Amendment (to the effect that, “A palatable diet being necessary to the health and well-being of a free People, the right of the People to bear salt shall not be infringed,”) is that it never occurred to them that any government would ever attempt to restrict such an inherent physiological necessity.

Of course, anyone who has observed our government at work – as it attempts to implement policies that require a fundamental change in human nature, or that require the repeal of the basic laws of economics – should not be surprised at the notion that our Progressive leaders would also try to repeal human physiology.

I mean, why the heck not?

In 2008, the Centers for Medicare and Medicaid Services (CMS) announced it would no longer pay for the treatment of “never events,” i.e., certain medical conditions in hospitalized patients which the Feds deem to be universally avoidable under all circumstances. These conditions included:

* Decubitus ulcers
* Two kinds of catheter-associated infections
* Air embolism
* Mediastinitis after coronary bypass surgery
* Transfusing patients with the wrong blood type
* Leaving objects inside surgery patients
* In-hospital falls

Then, having been delighted with the results of its original list (or dismayed that healthcare costs continued to skyrocket despite its original list) CMS subsequently proposed declaring several new conditions as “never events,” including:

* Surgical site infections following certain elective procedures
* Legionnaires’ disease
* Extreme blood sugar derangement
* A collapse of the lung resulting from medical treatment
* Delirium
* Ventilator-associated pneumonia
* Deep vein thrombosis or pulmonary embolism
* Staph infection in the bloodstream
* Disease associated with Clostridium difficile infection

Numerous commentators have expounded on the advisability of declaring these particular conditions to be “never events.” All agree that while certain of them clearly should never be permitted to happen (e.g., leaving sundry tools inside a patient’s abdomen, or transfusing the wrong blood), certain other ones are going to continue happening to some patients no matter how high the quality of the institution and the medical professionals.

Because this topic has been so well-covered in the medical blogosphere, DrRich does not need to comment any further on the unfairness of insisting that doctors prevent every single instance of conditions that are often not particularly preventable; or on the fact that insurance companies quickly followed Medicare’s lead and now also refuse to pay for these “never events;” or that hungry attorneys have voraciously begun suing doctors and hospitals for unavoidable complications because those complications have been federally designated as avoidable; or even the fact that, having so deftly expanded the horizons of what can be considered a “never event,” the feds have cleared the path for defining virtually any medical condition they choose as a “never event.”

(As a case in point, DrRich notes that the feds’ own guidelines on preventing delirium, referred to in their own “fact sheet” that purports to justify the expanded list of “never events” admits that there are no effective means of reliably preventing delirium.)

There’s also no point in physicians complaining publicly about this expanded list of “never events,” since the public is foursquare behind the notion that no medical complications should ever occur, and if they do occur it is somebody’s fault, and equally behind the notion that the Feds can squeeze quality into the system simply by demanding it to be so. Therefore, any doctors who openly objects to these new, tough quality measures will reveal themselves to be both anti-quality and low-quality doctors.

Rather, DrRich will refer back to the true mission of this blog, and simply explain to his readers how this new “never event” strategy furthers the true mission of Medicare and the insurers, which is to say, the covert rationing of healthcare.

For covert rationing is the chief operating principle of both the Feds and the private insurers. Indeed, their behavior resembles nothing more than the behavior of the closet, white-collar narcotic addict: while smiling their pasty smiles and desperately pretending to us that all of their new initiatives are only concerned with quality and nothing else, in reality, with every ounce of their being, their devious minds are constantly inventing new schemes to manipulate, deceive and twist each and every opportunity into some means of scoring their next covert-rationing “hit.”

Consequently, we cannot go wrong if we ask, every time we see some new healthcare program ostensibly aimed at quality improvement: Where’s the rationing?

One might think the rationing in this case is easy to spot. After all, if the feds stop paying for “never events” that actually cannot be avoided, they will save dollars right up front simply by refusing to pay for services rendered. But Medicare itself has estimated that its up-front annual savings from its original list of “never events” will be only about $20 million. And that seems hardly worth the effort.

The real savings will come from a place far more sinister than that.

The “never events” initiative – just as the Feds insist to us – is aimed at changing physicians’ behavior. But quite predictably, that behavioral change will not be in the arena of quality improvement (since no amount of quality improvement can stop “never events” that are inevitable). Rather, the behavioral change will be in the arena of risk avoidance.

While it is unlikely that doctors will ever refuse to care for high-risk patients who are experiencing genuine medical emergencies, it is quite likely they will stop recommending elective medical therapy for high-risk patients. Patients who seem particularly prone to infection, bed sores, falls, blood sugar abnormalities, blood clots, delirium, or who seem likely to need intravenous antibiotics (which predispose to C. difficile) will be particularly targeted. Roughly speaking, these patients will include diabetics, the elderly, anyone with a clotting abnormality or a history of blood clots, the obese, people with immune disorders, and the chronically ill. Physicians know by experience and instinct the sorts of patients to whom they ought to avoid offering elective medical services.

But in an era of evidence-based medicine, it is inevitable that savvy doctors will not want to rely on instinct and experience in this important matter. In order to conduct their risk avoidance in the most cost-effective way, they will want to base it on firm statistical evidence.

Accordingly, it is notable that investigators reporting in the Archives of Surgery last year began the important work of providing the kind of evidence-based risk avoidance which today’s physician actually needs. They published a large study designed to show which sorts of patients are most likely to experience post-operative “never events.” To the authors’ credit, their article was not written with the overt goal of providing a roadmap for risk avoidance. Instead it was written to show that “never events” are not really “never events” at all, but rather, are sometimes unavoidable complications; and that in certain readily-identifiable and (and obvious) subpopulations of patients, the incidence of “never events” is particularly high. That is, the authors were trying to convince the Central Authority that its policy on “never events” is far too Draconian, and that some leeway ought to be made for doctors who care for these higher-risk patients.

But of course the Central Authority already knows this, and also knows that the public fully supports its “never events” policy just as it is. The Central Authority, DrRich suspects, will see the Archives article for what it will end up becoming – a roadmap for surgeons who want to avoid the risk of encountering career-threatening “never events.” DrRich thinks Central Authority is quite satisfied with this study, and hopes to see more like it.

Conducting a risk/benefit analysis is nothing new to doctors. Doctors have always computed a risk/benefit analysis before recommending elective services to their patients (such as hip replacement, coronary artery bypass grafting, back surgery, gall bladder surgery, anti-obesity surgery, &c.) And in making those risk/benefit estimates, they have always taken into account the increased risk of complications faced by the elderly, the sick, the fat, and the malnourished.

But now, the “risk” part of the risk/benefit analysis suddenly must include three important new risks, and this time they are risks to the doctor him/herself, and not to the patients: 1) If any of these complications occur, no payment will be made for the (often very expensive) treatment the complication will require; 2) If a complication occurs, another “never event” will be tabulated in the federal database next to the doctor’s (and the hospital’s) name, which will inevitably show up in a public report card; and 3) Such a complication, previously considered a predictable risk, will now engender malpractice suits, based on the declaration by the Feds that these “never events” always constitute, by definition, grievous examples of poor-quality medicine.  The Archives article serves to place this new variety of risk analysis on firmer ground, and as such is an important new addition to the medical literature.

Lest anyone think that doctors would not really stop recommending clinically indicated care to patients just because of the personal risk it would entail, remember that it’s already happened, and is well documented. The government and the insurance companies have already conducted that experiment; it’s been completed, the results have been tabulated, reported, and duly noted. It turns out that doctors, like most other people, respond quite logically to negative incentives.

CMS knows exactly what it’s doing here.