As readers can imagine, few things could interrupt my temporary break from blogging – a break in which I have lost myself in the pleasures of figuring out how best to explain to novice readers the differences between the effective, relative and functional refractory periods of cardiac Purkinje fibers, and a host of other fascinating electrophysiologic arcana. With one’s brain wrapped around delights such as that, blogging fades to a barely remembered romp through some distant dreamscape.

One of the few things that could bring me back from these nether regions to the Covert Rationing Blog, if only for a moment, has happened. The esteemed Dr. Robert Centor, affectionately known as DB in the medical blogosphere, has made a comment on one of my posts, and it is a comment that deserves serious consideration. Further, I find I cannot give his comment appropriate justice by simply answering it with another comment. It requires more.

So, we interrupt this hiatus from blogging in order to give the kind of thoughtful response DB’s comment deserves.

I have been a reader of DB’s blog for several years – substantially longer than the nearly five years I have been writing the CRB. I consider DB to be the voice of internal medicine as it should be practiced. DB is a master of cutting through the fluff to get at the root of what is ailing the practice of medicine today. He has substantially influenced my thinking over the years, and many of DB’s writings have validated (in my mind, at least) certain of my syntheses of some key problems regarding the present state of medical practice. Indeed, out of sheer respect for DB I have dropped in this post the rather haughty 3rd person approach I traditionally use herein.

At one time I was a relatively frequent commenter on DB’s blog, and the exchanges that ensued between us have been some of the highlights of my blogging career (such as it is). But two years ago I stopped posting comments on DB’s Medical Rants, and I stopped making any reference here to DB or his blog. I did so for one simple reason.

It was two years ago that I had my public dust-up with the ACP over the issue of medical ethics. It was a dust-up that drew the notice and disapprobation of some individuals quite well placed within the ACP leadership. Knowing that DB is a member of the ACP’s Board of Regents, I feared that if I continued acting as if I were one of his “blogging buddies” it might reflect poorly on him. The ACP (an organization of which I was a proud member for over 25 years, quitting only when they published their New Medical Ethics in 2002) badly needs voices like DB’s. Indeed, the fact that they value his voice gives me hope. So, out of respect for him, and in consideration of what I guessed were his best interests, I stopped interacting with DB and his blog altogether, though I have remained a regular reader. I realize that, realistically, what I may do or not do almost certainly has no effect whatsoever on DB’s relationship with the ACP, but it was something I felt I needed to do.

In any case, that self-imposed avoidance has now been made moot by DB himself.

In his comment DB takes exception to one (or more likely, several) of my recent posts. I will reproduce his entire comment here:

“First, I admit to bias as a member of the ACP Board of Regents.

DrRich (whom I like and admire) has used a technique that we all use. He has established a straw man and beat that straw man into submission.

ACP advocates strongly for high-value, cost-conscious care (HVCCC). In fact a recent Annals article – Appropriate Use of Screening and Diagnostic Tests to Foster High-Value, Cost-Conscious Care – http://www.annals.org/content/156/2/147.abstract – very explicitly attacks low value high cost care.

Advocating for HVCCC does not mean advocating for rationing based on cost alone.

As DrRich always states, we have covert rationing and we believe that rationing has no relation to value.

ACP has challenged all physicians to avoid medications and tests that do not have high value. How is that “herd medicine”?

Please review the recommendations in the recent Annals article and tell us where we have developed recommendations for cost reasons only.

I admire your debating skills, but in my opinion you are not addressing the same question that we are addressing. I speak from clinical experience. I see too many tests ordered that cannot help the patient. I see too many treatments that cost too much without a clear advantage over less expensive treatments.

We should strive for high value care for all our patients. We should eschew low value expensive care for most patients (of course one can construct exceptions to this generalization). Let’s not let hyperbole confuse the issue. We cannot afford unnecessary expenses. We challenge you to define unnecessary. I think you can.”

I believe DB has misunderstood my main argument. This is not his fault. I have been accused more than once of being somewhat obtuse. So let me state it very explicitly:

1) It has been determined that individualized decision making by doctors and patients is the problem, and to resolve this problem clinical decisions need to be centralized.*
2) Obamacare renders much individualized decision making illegal, and establishes formal mechanisms for centralized decision making.
3) The ACP’s New Medical Ethics, whether by intention or not, has allowed agents of the Central Authority to argue that individualized decision making is unethical.
4) Centralized decision making will likely yield better results for the collective, better results for the “average” patients, but suboptimal results for people on the wrong side of the distribution curve – and terrible results for people on the tail of the curve. DB himself has written about this tail.

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* From the book “New Rules,” by Berwick and Brennan:

“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.”

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There is nothing in my argument that says physicians should avoid attempting to practice high-value medicine. Obviously, they should. There is nothing in this argument that says it is wrong or counterproductive for the ACP (or other professional organizations) to devise publications, guidelines, opinions, or any other kind of aid to assist doctors in making appropriate clinical decisions that will minimize waste for society and harm to their patients. Doing these things is good for the healthcare system and for mankind.

What is wrong is a system that says that centrally-generated clinical “guidelines” must be followed to the letter by all doctors for all patients under all circumstances, and that failing to do so is both illegal and unethical.

The document to which DB refers me – an attempt by the ACP to assign values to certain clinical services – is a good one, and I am sure clinicians should find it helpful. I can’t help but believe that he sent me to this particular document because it explicitly calls out implantable defibrillators (the development of which played a significant role in my professional career) as a high-value medical service. That’s very nice.

But this fact leads me to use, as an example of what I’m talking about, the abuse of ICD guidelines by the Central Authority. A year ago an article appeared in JAMA complaining that 22% of ICD implants did not meet the guidelines. That number (which seems about right to me, if guidelines were being treated as just that) was widely castigated as evidence that doctors were engaging in widespread abuse of this expensive medical device. This was followed, 2 weeks later, by an announcement that the Department of Justice was conducting an investigation of guideline violations by ICD implanters. As a first step in this investigation, the DOJ elicited the cooperation of the Heart Rhythm Society – the professional organization of electrophysiologists – and the HRS let out that it was effectively gagged from further comment or action on behalf of its members for the duration of the investigation.

The specific part of the ICD guidelines that produced the majority of the “violations” was not that ICDs were being used in people who did not really need them. Rather, it was that ICDs were being implanted earlier than the Feds preferred for people who, everyone agreed, should have an ICD. That is, implanters were not waiting the full mandated 4 – 6 weeks after a heart attack, or after heart failure was diagnosed, before implanting ICDs in some of their patients. Two points about this: First, there are clearly individuals who should receive their ICDs within the first month of a heart attack or heart failure diagnosis, despite what the guidelines say. (For instance, if the patient also has an indication for a pacemaker – not an uncommon thing – following the guidelines would require first implanting a pacemaker, then, a few weeks later, doing a second invasive procedure to replace it with an ICD). Second, the clinical evidence supporting this 4 – 6 week waiting period is based on two fundamentally flawed studies, and constituted the weakest part of the clinical evidence regarding ICDs, and while it is now apparently considered settled science if not gospel, it was originally considered highly controversial when the guidelines first appeared.

We don’t know what the results of the DOJ’s investigation will be. Perhaps nothing will come of it and no electrophysiologists will go to jail this time.

Here’s what we do know:

- Doctors are expected to follow clinical guidelines to the letter, with every patient, whether it makes sense for an individual or not.
- Doctors who are not following centralized guidelines to the letter are behaving illegally, and the DOJ – that’s the DEPARTMENT OF JUSTICE people, and not HHS or Medicare – will investigate, and at least threaten criminal prosecution.
- Doctors who are not following centralized guidelines to the letter are behaving unethically. (Go back and re-read the commentary from the press and from other physicians, especially physicians who strongly support Obamacare’s centralized decision making, about the ethics of these ICD-guideline-violators.)
- Such legal and ethical intimidation will prevent doctors from “violating” guidelines for their individual patients who are a standard deviation or two away from the mean, and who clearly need an exception.

That’s my argument. The activities of the ACP, vis a vis establishing helpful studies of the relative clinical value of various clinical actions, or even guidelines for clinical practice (if treated as actual guidelines), are to be lauded and not criticized, and I so laud them.

The ACP has not instituted herd medicine, nor advocated it explicitly, to my knowledge. My only criticism of the ACP has to do with their altering the precepts of medical ethics to make it ethically compatible for doctors to go along with herd medicine. The Central Authority on its own volition has taken it the rest of the way – to where it’s unethical NOT to go along with heard medicine. This “adjustment” of medical ethics is just what the Central Authority needed in order to validate its policy of centralized decision making, and the ACP provided it. The glee on the part of the government’s agents in response to the ACP’s New Ethics is palpable.

I still find this a sad, sad thing for the profession, and especially for patients. I also find it very sad for the ACP itself which, by producing the kind of helpful resources to which DB has referred us, would continue to be a great force for good – were it not for this one very basic, very fundamental, very critical, and therefore utterly tragic flaw.

Podcast:

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?

Podcast:

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.

Podcast:

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.

After extensive analysis by a committee of hand-picked experts, with much debate and with some dissension, the following have been identified as DrRich’s Top Ten Posts of 2011.

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.

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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.

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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.
____

Yet, regular readers will know that the New York Times has served as a regular source of material for DrRich here at the CRB, and little of what he has written in response to that material has been supportive of it. Indeed, the opposite is true.

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

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

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

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

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

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

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

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

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

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

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

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

Theory A:

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

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

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

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

Theory B:

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

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

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

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

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

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

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

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

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

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

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

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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.

Podcast:

A couple of weeks ago, a swarm of Federal agents from the Fish and Wildlife Service, armed with automatic weapons, suddenly raided the Gibson Guitar Company and confiscated raw materials and finished guitars, apparently because Gibson allegedly violated the Lacey Act in their importation of exotic wood.  Spokespersons from Gibson insist that they purchased the wood legally, that the sale was approved by Indian authorities, and that they have the paperwork to prove it.

To DrRich, the interesting aspects of this episode are: a} The Jobs! Jobs! Jobs! Obama administration is happy to raid and disable a business – a manufacturing business at that – that has been hiring Americans, in order to enforce murky, difficult-to-interpret laws which require Americans to comply with even more difficult-to-interpret and even murkier laws in foreign lands. b) The administration is willing to enforce such laws in such a way as to induce maximum intimidation. And c), they are willing to do so selectively. (Several guitar companies, which have not been raided, also import the same wood from the same sources.)

DrRich stipulates that neither he – nor anyone else – knows all the facts of this case, and that perhaps Gibson really is guilty of imperfect compliance with the Lacey Act.  However, from what is known publicly, even if this were true, this episode would appear to be a case of selective enforcement. DrRich does not know whether the Administration would pick on Gibson because its CEO is a well-known Republican, or to teach a lesson to the people of Tennessee because at least one of their Senators has been seen consorting with the Tea Party, or because Gibson is non-unionized, or for some other reason.

The current version of the Lacey Act was arguably promulgated for good reasons, aimed as it was, ostensibly at least, at protecting rare species. But full compliance with the Lacey Act requires companies to document they are in full compliance with changeable, obscure and opaque laws in foreign lands, and in a fundmental sense is impracticable. America has many laws, rules, regulations, and guidelines that are just like this – for which it is, for all practical purposes, impossible to be in full compliance.

Such laws and regulations are very useful to the government, because it allows them to declare, at a time of their choosing, almost anyone who is functioning under those laws to be criminals. If Americans understand that the only thing standing between them and a raid by Federal agents armed with automatic weapons is the pleasure of the Central Authority, then smart Americans will do whatever they can to curry that pleasure.

DrRich calls it the Regulatory Speed Trap. The Regulatory Speed Trap can be recognized by its typical 5-step pattern;

1) Over a long period of time, regulators will promulgate a confusing array of disparate, vague, poorly worded, obscure and mutually incompatible rules, regulations and guidelines.
2) Individuals or companies which need to provide their products or services despite such hard-to-interpret regulations, will necessarily render their own interpretations (usually with the assitance of attorneys, consultants, and the regulators themselves), and will act according to those interpretations.
3) By their apparent concurrence with, or at least by their failure to object to, such interpretations of the rules, the regulators over time allow de facto standards of behavior to become established.
4) When it becomes to their advantage, the regulators will reinterpret the ambiguous regulations in such a way that the formerly tolerated de facto standards suddenly become grievous violations.
5) Regulators aggressively, but selectively, prosecute newly felonious providers of products or services.

Basic to the Regulatory Speed Trap is an underlying set of complicated and contradictory rules and regulations. In most instances, such as with the Medicare regulations that have evolved over the past several decades, the complexity and self-contradictions grow almost organically over time, and are not planned in any way.  In other instances – such as with the Lacey Act – some new regulations that cannot be complied with are created de novo. And in yet other circumstances – such as the Obamacare legislation or the Dodd-Frank legislation – an entire, massive, tangled web of impossible regulations is painstakingly created out of whole cloth. (This is likely why it is taking so long to render each of these new laws into their hundreds of thousands of pages of regulations.)

It is a rule of nature that bureaucracies evolve away from clarity and toward maximum complexity. But the resultant regulatory morass does not necessarily have to produce fatal paralysis. Societies have thrived for long periods of time despite such bureaucratic complexity. (The Byzantine Empire for instance, whose very name came to symbolize the bureaucratic tangle, lasted for a thousand years.) These societies have thrived, however, only because bureaucrats have allowed de facto interpretations and standards of behavior to develop under their watchful eyes. This sort of benign oversight permits societal commerce to continue to function within some reasonable bounds.

But the modus operendi of our Progressive leaders – in their perpetual attempt to establish the perfect society – is to control “everything” from the top down. And what they have discovered, to their unending delight, is that in a mature bureaucracy – one that has found a way to function despite a tangle of vague and contradictory regulations – is that Everyone Is Always Guilty Of Something.

And if everyone is always guilty of something, then the judicious use of the Regulatory Speed Trap, which is to say, the selective enforcement of inherently ambiguous regulations, becomes a useful tool for achieving Social Justice. By such selective enforcement they can punish their enemies (the enemies of the Progressive Program), reward their friends, and press their own agenda as they see fit.

This, DrRich submits, is what we see happening today to the Gibson Guitar Company, and for that matter, to Boeing.

Less obvious to the average citizen, but very obvious to individuals and organizations working within it, is that the same thing holds for the American healthcare system. Even before all the Obamacare regulations are published, the morass of already-existing rules, regulations and “guidelines” means that, at any given time, the Central Authority can suddenly construe some rule in such a way that virtually any worker or any institution dealing with the healthcare system becomes a criminal. The Central Authority has already exercised its awesome and arbitrary power to do so, in selected and circumscribed cases, and to good effect. Today, healthcare workers and institutions – and especially the medical profession – know that staying on the good side of the Feds is Job One.

Which means that doing what’s best for your patient can be no higher than Job Two*. It is not only “ethical” to act for the good of the collective instead of the individual patient, it is also the only way to optimize your chances of staying on the right side of the law – whichever law, that is, the Feds choose to reinterpret at any given time.

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*For doctors, doing what’s best for patients is actually Job Three. The top priority is maintaining your professional viability (by keeping the Feds happy); the second priority is protecting your turf against encroaching physicians from other specialties; and the third priority is the patients. This order of priorities does not mean that doctors are evil; if they ignore the first two priorities, they will not be able to do anything at all for their patients.
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Most doctors are very smart and can adjust to these or any other rules of engagement. It is the patients who are well and truly screwed by the Regulatory Speed Trap.

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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.

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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?