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.

The publisher insists that I update this book every few years, to keep it “fresh.” Because it is a very basic textbook, and because the basics of electrophysiology remain nearly unchanged, my chief aim in doing these revisions is not to screw it up too much.

A secondary aim is to slip past the eagle-eyed editors (who have the reputation of the publishing house to uphold, and who believe textbooks of medicine should be serious tracts) as much humor as possible – which means I have to disguise it. (Regular readers of this blog will know what I mean.) By this means I keep myself engaged and entertained in what otherwise – after all this time – might have become mere tedium.

It is in the interest of my contractual obligation to finish this project in a timely fashion that I have had to leave off – for what I intend will be a very brief interval – composing posts for the Covert Rationing Blog.

I hope that my few readers will indulge me in this hiatus, and in the meantime that you will keep in mind (without my constant reminders) that they really are out to get you.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

So open wide and say Moo.

On the same day that DrRich published his post about the American College of Physicians’ new Ethics Manual, Rob Stein of NPR’s Health Blog did the same thing. In his post, Mr. Stein took particular notice of the ACP’s admonition to physicians that, in order to practice medicine ethically, they must practice parsimoniously.

DrRich flatters himself to believe that he may be the one who called Mr. Stein’s attention to this remarkable terminology. Mr. Stein had contacted DrRich just prior to the New Year’s holiday for his reaction to the new Ethics Manual – and DrRich responded with a lengthy e-mail containing a substantial riff on the ACP’s usage of “parsimonious” (a riff that was not dissimilar to the one appearing here on the CRB a few days later).

In any case, whether DrRich had anything to do with his focus or not, Mr. Stein (being a reporter instead of a mere ranter) actually interviewed several persons of interest regarding this curious terminology. Dr. Scott Gottlieb of the American Enterprise Institute and Daniel Callahan of the Hastings Center appeared sympathetic to DrRich’s take on “parsimonious,” that is, that this word, at best, carries some very negative connotations under any circumstance, but particularly when it is used in the context of providing healthcare to people who need it. (DrRich himself was not mentioned in the NPR article. This undoubtedly shows good judgment on the part of Mr. Stein, who has his reputation to think of.)

The most interesting response to Mr. Stein’s questions on “parsimonious” was offered by Dr. Virginia Hood, current president of the ACP. She strongly defended the use of the word, saying, “Parsimonious is a good word in the sense that it means that you use only what’s necessary. I don’t see a particular problem with that. Maybe it has some connotations where people think frugality or being parsimonious is the same as being mean or inadequate. But I don’t think that is the real meaning of that word.”

So the mystery raised by DrRich in his last post is apparently resolved. When the ACP says “parsimonious” it turns out they are not referring at all to the “theory of parsimony” (or Occam’s Razor), the theory which states that when there is more than one explanation for a series of observations, one must always default to the simplest available explanation. It seems a shame that this is not what the ACP was referring to. While it would have been terribly misguided for the ACP to make an unqualified demand that doctors apply the theory of parsimony to all questions that arise in medical practice, at least they would have seemed somewhat sophisticated in doing so. For many academic papers have been written about the theory of parsimony, and some of them border on the esoteric.

But astoundingly, that’s apparently not what the ACP meant at all. It turns out that what they meant was, in fact, parsimonious. Dr. Hood purports to believe that “the real meaning of the word” is “efficient.” But she should know that it is not. According to Roget’s II New Thesaurus, parsimonious is “ungenerously or pettily reluctant to spend money.” Webster’s New World Dictionary gives “stinginess, extreme frugality.” Other sources DrRich has found list similar definitions, such as: excessively unwilling to spend, penny-pinching, miserly, sparing, grasping, tight, close, niggardly, illiberal, mean, avaricious, covetous, rapacious and tight-assed. Only one source even mentioned the word “efficient,” and it was the 15th or 16th meaning. The dictionaries make it clear that being “parsimonious” is not a thing to be admired.

Students of philosophy, religion, and psychology have known, at least since Dante, that a vice is a virtue carried to extremes. The vice of lust is a perversion of the virtue of love. Servility is a perversion of humility. Recklessness is a perversion of courage.

And parsimony (or miserliness, or stinginess, or any of the many synonyms that exist for this very common vice) is a perversion of thrift. We do not celebrate the addled stalker because his vice is rooted in a perverted form of love. We ought not celebrate parsimony because, despite its perversion into something awful, it is based on efficiency.

Notwithstanding Dr. Hood’s protests to the contrary, when the ACP admonishes physicians, as a matter of ethics, to provide healthcare parsimoniously, that is not a good thing.

While Dr. Hood may herself not be a lexicographer, DrRich thinks we can be fairly certain that, for a document like the ACP’s Ethics Manual, before final publication each and every word is carefully parsed, analyzed and considered by a number of astute and highly educated individuals. Indeed, one notes that the lead author of this document is an attorney, and attorneys are notorious for understanding every nuance of every word they allow into written documents. One would assume that this is especially true for a word which is so important to the message that it is being placed in a special call-out box, so nobody will miss it. It is simply not believable that “parsimonious” – which describes a well-known vice – managed to slip into this document inadvertently as a synonym for “efficient,” as Dr. Hood suggests. That explanation, of all the possible explanations, is simply not credible.

So perhaps Dr. Hood misspoke, and “parsimonious” really was referring to the theory of parsimony after all, and she either did not realize this (not being a lexicographer), or simply forgot. The only other credible explanation, which Dr. Hood indignantly denies, is that the ACP actually does mean for doctors to practice medicine parsimoniously – with all its negative connotations – and that her present dissembling is merely dissembling.

As it happens, DrRich has a brief history with Dr. Hood. Two years ago, the Covert Rationing Blog and the ACP Advocate Blog were both named as finalists for a Medical Weblog award in the category of Health Policy and Medical Ethics. So DrRich suddenly found himself in an ethics competition with the very organization that had published the notorious “New Physician Charter on Medical Professionalism,” and thus had destroyed the very foundation of medical ethics.  He could not resist the opportunity to publicly challenge the ACP, under the spotlight (and protection) of the Medical Weblog competition, to an open debate on medical ethics.

You can read all about the ensuing exchange here. What may be of some interest for our present purposes is that it was Dr. Hood herself – at the time the Chairperson of the ACP’s Committee on Ethics, Professionalism, and Human Rights – who finally drafted the ACP’s public response to DrRich. And interestingly, in her response (which was heavy on condescension but light on logic) Dr. Hood invoked the need for parsimonious care. So the ACP’s use of this word was not a momentary oversight; instead it has been rolling off their collective tongues for years, as a descriptor for what they consider to be the ideal approach to the practice of medicine.

Another aspect of that Medical Weblog competition between DrRich and the ACP is more to the point at hand, namely, the interesting manner in which the ACP finally beat DrRich out for the award. The way the competition works is that a short list of finalists is determined by a committee of judges, and then for two weeks anyone who is interested can vote for their blog of choice. The voting system allows only one vote per IP address (so if 20 people all vote from their computers tied into a company network, only one vote is counted). During the voting period, a running tally of results is shown to anyone who cares to see it.

Clearly, given the public spectacle DrRich had made regarding the righteousness (or lack of it) of the ACP’s stance on medical ethics, it would have been deeply embarrassing for the ACP to lose this medical ethics contest. So it was probably troubling to that organization when DrRich mounted a substantial lead early on, and held that lead for two weeks, right up until the last three hours before the voting ended, which, as it happened, occurred at midnight on Sunday, February 14. Then, late on Valentine’s night, when most normal people were with their loved ones doing, well, Valentiney things, apparently a large number of ACP members spontaneously rousted themselves from their activities, logged on to their computers, and voted for the ACP – just enough of them to overtake DrRich, and then to maintain a steady 10 – 20 vote lead for the remaining hour or two of the voting period.

DrRich is not relating this story because he is bitter, nor is he complaining. (This blog won the Medical Weblog award the following year, so there is nothing for DrRich to complain about.) Rather, he was and is deeply amused by these events, and he relates this story for a very pertinent reason – namely, for the purpose of illustrating the shortcomings of the “theory of parsimony.”

For what are the possible explanations for the ACP’s stunning last minute victory? One explanation is that, in the waning moments of Valentine’s Day, members of the ACP finally got around to voting. This is of course possible. These are internal medicine specialists, and many of them are the guys (and girls) you knew in college who looked forward to football Saturdays because the library would always be so much quieter. So it is indeed possible that the ACP membership had entered into their iPhones, weeks earlier, a reminder to vote for the ACP at 11:59 PM on Sunday, February 14. Perhaps they figured they would be logged on to their computers at that moment anyway, reading the latest research on the complement cascade.

Another possible explanation is that someone affiliated with the ACP, realizing how deeply embarrassing it would be to lose an ethics contest to a pain in the ass like DrRich, figured out a way to defeat the voting system’s firewall, and to enter the precise number of votes they needed at the last minute in order to gain a victory and save face. We have seen examples in electoral politics, over and over again and perhaps as recently as last Tuesday night in Iowa, that in close contests it is best to withhold a bolus of the votes you control until the last minute, when you know just how many votes you need.

DrRich is not accusing the ACP of anything, of course, as he has no direct proof that they behaved badly – just a series of observations that have more than one possible explanation. But he admits to finding it delicious that a straightforward application of the theory of parsimony – always choosing the simplest explanation for a series of observations – leads us to the conclusion that agents of the ACP apparently cheated in order to win an ETHICS contest.*

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*If they actually did this, of course, some would say it would indicate that the ACP has disqualified itself from ever establishing ethical rules for anyone.  But actually, it would simply be another illustration of utilitarian ethics, where important ends always justify whatever means are necessary to achieve it.

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Since we know beyond doubt that the ACP would never have done such a thing, and that the ACP won that competition fair and square, DrRich has therefore just demonstrated that applying the theory of parsimony, after all, will often enough lead to incorrect conclusions, and therefore the ACP ought not demand that doctors apply it as a matter of course in all questions of life and death.

So either way, whether the ACP’s use of the word “parsimonious” was supposed to indicate that doctors ought to be stingy and miserly in delivering medical care, or whether they were obligating doctors to always apply Occam’s Razor to medical decisionmaking, delivering parsimonious medical care is a very bad idea, and certainly ought not to be an ethical mandate for physicians.

The leadership of the ACP ought to know this. Indeed, Occam’s Razor suggests that they do know this, which would be the simplest explanation for why, when challenged on their choice of the word “parsimonious,” they insist that they mean the one thing that makes no sense whatsoever.

DrRich wants to record his sympathy for the recommendation, made by the National Transportation Safety Board this week, that all cell phone use by automobile drivers be banned at the federal level. When our government gives us new rules that are for our own good, we should be thankful and not critical.

The caterwauling we’re hearing from some Conservatives over this issue is a gross overreaction, and entirely unreasonable. For one thing, the carnage being produced by cell-phone-using drivers has exploded beyond all reason, and we simply cannot be expected to wait for each of the state governments to act, each at its own leisurely pace.

Furthermore, we should all recognize that regulating the cell phone usage of Americans, especially while Americans are behind the wheel, is now well within the purview of the federal government. This is because, under Obamacare, the Feds are ultimately on the hook to pay for all the extra medical care being generated by the automobile accidents caused by these thoughtless drivers. Indeed, Obamacare ultimately gives the Feds the authority to regulate all human activity that impacts the likelihood that people will need to engage the healthcare system – from what you eat to what hobbies you take up.

The recommended ban on cell phones was based entirely on scientific data, and certainly cannot be assailed from that aspect. The case that reportedly prompted the NTSB to take up this issue was that of the Missouri man who apparently caused a fatal accident whilst texting. We cannot ask the perpetrator himself about it, since he died in the accident, but all the news reports say that he had sent 11 text messages in the 10 minutes prior to the accident. That, to the uninformed, is an actual statistic. Evidence like that certainly constitutes all the justification the Feds could ever be expected to provide for a ban on all cell-phone usage, both texting and talking, both hand-held and hands-free.

Some, of course, have questioned the recommendation that even hands-free cell phones should be banned. If you are among these sadly uninformed individuals, DrRich points you to a report in the Pittsburgh Post-Gazette addressing this very issue, in which Carnegie Mellon University neuroscientist Marcel Just explains, “listening to someone on the other end of the phone reduces the brain activity associated with driving by more than one-third.”

So there you go. The message from neuroscience is clear.  Just the act of listening to a conversation while you are behind the wheel increases your risk by 33%.  And unlike Conservatives (who always seem to fight against the logical application of scientific fact for reasons of practicality, ethics, tradition, religion or out-and-out denial), the Progressives on the NTSB simply followed the science. Cell phones should be banned, whether hand-held or hands-free.

Indeed, one can argue that the NTSB was too timid with their recommendations.  Obviously, this 33% increase in risk will not depend on whether the conversation you are listening to is being piped through your car speakers by some sort of Bluetooth arrangement, or whether it is being generated by the person in the passenger’s seat.  Listening, after all, is listening. And settled science says: no listening while driving.

Earlier today DrRich and his beloved spouse of some 37 years, Mrs. DrRich, were driving somewhere for some purpose or another that was none of DrRich’s doing, and he decided to test out this proposition. So when she started in with her deadly habit of talking to him while he was driving, thus attempting to engage him in a potentially fatal listening process, DrRich politely invited her to immediate silence for the duration of the trip, admonishing, “Don’t be such a menace to our society! You’ll have the FBI upon us in minutes!”  This tactic worked out so well that not only did she remain silent for the entire trip, but has maintained that silence to this very moment, and seems to be willing to continue it for quite some time. At least we were not killed in a traffic accident.

Undoubtedly the NTSB will be greatly disappointed, a few years from now, when they re-do their statistics and find out that a lot of people are still dying in automobile accidents despite the ban on cell phones. DrRich knows this because he can remember way back to the day when there were no cell phones, and can recall that our highways were every bit the charnel house they are today.  Presumably, this is at least partially because conversations took place in automobiles even before cell phones were invented.

But fear not, for there will be plenty of other things for the Feds to ban to make our highways safer. For instance, if listening to a simple conversation while driving is a deadly act, then surely one must ban listening to talk shows, which just get everybody mad anyway. It must also be true that radios themselves, and MP3 players, and all in-car entertainment systems ought to go, for just think how very distracting it all is. And children. They definitely ought to ban children from ever riding in cars.

You see, dear reader, as scientifically pure and as well meaning as our Central Authority is,  and however much we may sympathize with their intent, the government is going about this all wrong. If the Feds want to limit the healthcare expenses they are shelling out for people injured in traffic accidents, the best way to do this will not be to try to come up with regulations to prevent drivers from being distracted. Drivers will always be distracted, even if you strip the cockpit of automobiles down to a steering wheel, accelerator and brakes. They will be distracted by a hangnail, or by a song coursing through their heads, or by rehearsing an apology to (say) an angry spouse, or by something they see out the window. Regulating away all driving distractions is impossible.

Once again, the Progressives’ program for societal perfection smacks up against human nature.  Getting the great unwashed to always act for the good of the collective – to put aside their propensity to become distracted while driving, say, or to stop trying to accumulate personal wealth -  quickly becomes an extremely frustrating endeavor for Progressives leaders, and it is what invariably seems to lead them to purges and pogroms, or at least to sundry exercises in eugenics. In the case of regulating distracted driving for the benefit of the collective, Progressives might as well take a lesson from history and just cut right to the chase.

For if the Feds really want to save all that money they’re now spending patching up survivors of automobile accidents, there’s a way that is guaranteed to work, and it’s not that far removed from where Progressives always seem to wind up anyway:

1) Remove seat belts and airbags from all cars.
2) Eliminate the speed limit on US highways.
3) Make sure tethered cell phones are installed as standard equipment in all cars.
4) Several times each day, announce over the radio a contest in which the Federal government will award $5,000, tax free, to the next 100 callers.
5) Use a different call-in number each time, to require manual dialing.

There will be few survivors.

Call it self-selected eugenics. And since Obamacare does not offer to pay for funerals, it will all be good.

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.

This past summer, DrRich wrote a post on the utter arrogance of the public health experts who are urging the FDA – and international bodies of busybodies – to mandate a policy of strict sodium restriction across the globe.

DrRich attempted to show how such a broad-based salt restriction at this juncture is ill-advised for three reasons. First, the conclusion that a population-wide salt restriction would actually do any good is not based on any actual prospective studies, but on a contrived extrapolation of observational data. Second, there is some evidence that a salt restriction would be harmful to at least a substantial minority of people, even if the overall effect on the population turns out to be positive. And third, there is good reason to believe that the degree of sodium restriction which is being recommended by the public health experts is below the level which is dictated by human physiology.

Perhaps salt restriction for the entire population will turn out to be a good idea. But perhaps not. So in his previous post, DrRich was advocating a prospective, randomized controlled trial to test this proposition before just going ahead and inflicting it upon hundreds of millions of Americans.

And now, as it happens, in recent weeks new studies have been published which question the safety of salt restriction for the whole population. In fact, five studies have been published just this year suggesting that salt restriction might be unsafe.

The latest, published this week in the Journal of the American Medical Association,  suggests that when you compare cardiovascular events (such as heart attack and stroke) to sodium intake, the incidence of those events follows a “J” curve. That is, cardiovascular events are lowest at an “optimal” level of sodium intake. But if sodium intake goes above that optimal level – or if it goes below it – the incidence of cardiovascular events increases.

According to this study, the “optimal” level of daily sodium intake is 4000 – 5999 mg of sodium per day. Cardiac outcomes worsen for those with sodium intakes above or below those values.

And, of course, the public health experts are recommending sodium intakes far below the 4000 mg threshold. They recommend (and urge world governments to enforce) sodium restrictions of 1500 mg per day for the people they consider to be at high risk (which amounts to about half of us), and restrictions of 2300 mg per day for the rest of us.

This kind of restriction would place everyone on an unenviable portion of the J curve, according to this new study, and would risk exposing all of us to an excess of cardiovascular disease.

The public health experts, of course, will not take this slander lying down, and accordingly have been quick to respond. Interestingly, their response sounds a lot like the response of the global warming experts whenever someone has the audacity to introduce new evidence that questions some of their conclusions.

Heartwire quotes Dr Graham MacGregor of London’s Wolfson Institute of Preventive Medicine (and a major sodium restriction guru) as saying, “[These new studies] are a minor irritation that causes us a bit of aggravation, and we have to talk to journalists about it, because they are not interested in news saying salt is dangerous.” MacGregor insists that the need for global sodium restriction (like global warming) is a settled issue.  “What [these irritating investigators] fail to understand is that the FDA is not asking for evidence about why salt should be reduced, they are asking how it should be reduced.” So apparently, new data need not apply.  It is neither being sought, nor will it be accepted.

Other experts have pointed out that these new studies urging caution on restricting salt were not the kind of prospective, randomized controlled trials that are so valued in medicine, so their results should not be taken too seriously.

DrRich might be more inclined to agree with this admonition if the studies that suggest we ought to employ severe, widespread salt restrictions were randomized, controlled trials. But they, also, are not.

What we have is two sets of very confusing observational data that can be interpreted to say different things. It may be true that a severe population-wide salt restriction would be a huge boon to mankind. But it may also be true that it would harm more people than it would help – or that it would harm and help about the same number, so the overall results would be the same.

The fact is, we just don’t know.

We have already seen the harm that can be done when we allow public health experts to launch major population-wide dietary changes, without adequately studying what their effects will be. Especially given the increasing evidence of the harms that might be done by it, we are nuts if we allow the arrogant expert class to enforce a salt restriction program on all of us, before we adequately study its likely results.

Of course, the whole thrust of our new healthcare system is to allow the experts to practice medicine on the whole population.  So urging caution or even a certain amount of circumspection on this newly-empowered expert class is destined to be a futile exercise.

A key goal of the Central Authority, as it contemplates how best to run our healthcare system, is to do whatever it can to stifle medical progress. Medical progress usually means introducing new drugs or new medical devices, which are often very expensive in themselves, and worse, which often threaten to improve the survival of some category of patients with chronic disease. So typically, medical progress greatly multiplies the costs of healthcare, and all the Central Authority gets in return is more chronically ill people to contend with. For this reason, suppressing medical progress is a critical aspect of covert healthcare rationing.

It goes without saying that a major tactic in achieving this goal is to demonize the drug companies. If the pharmaceutical industry can be made out to be sufficiently evil, corrupt, greedy, and callous to the needs of the people, then it will become the duty of our leaders to constrain them, and in so doing, to limit their ability to develop and introduce new products. This is easily done by adding daunting new regulations, or by piling on oppressive new taxes, or by legislating “windfall profits” penalties, or by using the threat of the regulatory speed trap to threaten them with massive fines or imprisonment. It is indeed fortunate for the Central Authority that the drug companies are, in fact, not the most fastidious members of the corporate community, and that their actions and methods often suggest many fruitful avenues for demonization.

One such avenue that is particularly fruitful, since it recruits the public squarely into the camp of the prosecutorial horde, is to show how the corrupt pharmaceutical industry feeds at the trough of the American taxpayer.

A few years ago, to specifically document this sort of reprehensible behavior, the New York Times pointed us to the case of Dr. Laszlo Bito and the anti-glaucoma drug Xalatan.

In the early 1980s Dr. Bito, a researcher at Columbia University, made a key discovery about a new class of substances that could potentially treat glaucoma. His research was funded with American tax dollars through the National Institutes of Health.

Subsequently, the pharmaceutical giant Pharmacia purchased the rights to Bito’s discovery for a mere $150,000. Based on Bito’s tax-supported work, eventually Pharmacia released the anti-glaucoma eyedrop preparation Xalatan. Xalatan rapidly became a worldwide best-seller, yielding as much as $500 million in sales per year. For their part in this unalloyed success story, Columbia University has netted over $20 million in licensing fees and royalties, and Bito himself became a millionaire.

Meanwhile American glaucoma sufferers are forced to spend upwards of $50 every six weeks for a tiny vial of the drug, which costs the company only a small fraction of that amount to produce, and whose discovery the glaucoma sufferers paid for with their own tax dollars. And, as if to guild this already brazen injustice, Pharmacia makes Xalatan available in Canada, France, and most other countries around the world (where taxpayers decidedly did not support the discovery of the drug), for less than half what American patients pay for it.

It seems, the Times points out, that the American taxpayers are the only parties in this little scheme who reap no financial return on their investment. All they got were some expensive eyedrops.

And so, drug-company demonizers would have us conclude, this is a particularly egregious example of how the evil pharmaceutical industry is ripping us off. Not only are the drug companies mercilessly profiteering from sick Americans (which indeed is their openly-admitted business model), but they are also picking the pocket of every American by using our tax dollars to invent new drugs, then selling those drugs back to us at exorbitant prices. This, one could reasonably argue, is at least as sociopathic as anything the tobacco companies ever did. (The tobacco companies, in contrast, at least had the good graces to eventually stop claiming that their products were beneficial to one’s health.)

And (we in the great unwashed are all supposed to agree), if this reprehensible behavior doesn’t give our government the right to control the prices charged by drug companies, one would be hard pressed to say what does.

DrRich certainly doesn’t want to absolve the pharmaceutical industry of all responsibility for drug prices that seem obviously too high, or for the striking disparities we see in the prices they charge for their drugs between the U.S. and other countries. He has read the complex justifications, published by apologists for the pharmaceutical industry, as to why drugs in Canada cost so much less than in the U.S., and why a tablet whose actual manufacturing cost is five cents is sold to our elderly sick for five dollars. DrRich thinks that, despite all the pretty explanations the pharmaceutical industry gives for these “seeming disparities,” drug companies simply do what every other industry does – they charge the highest price the market will bear, for each market in which they participate. If they didn’t do this, they would be abrogating their fiduciary responsibilities to their shareholders.

There is much not to like about high drug prices, or the fact that people in other countries reap the benefits of American research for far lower prices than Americans do. And it is reasonable for us to seek to address these pricing issues. But as we address certain inequities in drug pricing, we should be careful that in doing so we don’t throw the baby out with the bath water. So if we’re going to alter the arrangement we have with the pharmaceutical industry, let’s be clear on how that arrangement works, and why we set it up in the first place to operate as it now does.

Consider once again the glaucoma drug Xalatan, and consider how Dr. Bito’s discovery was actually used by Pharmacia.

Bito did not discover a finished product. Instead he discovered a new concept for reducing intraocular pressure (that is, for treating glaucoma), and demonstrated that it could be effective – but the specific compound he discovered was not marketable. In fact, it was so highly irritating when applied to the eye that it was simply not suitable for human use. (DrRich does not understand why the drug companies are the evil players in this story, when Columbia University so obviously allowed research to proceed in their facilities in which irritating substances were intentionally placed into the eyes of bunnies or other cute animals.) Indeed, Bito’s new compound was so impressively unusable that, before Pharmacia bought the rights, his discovery had been offered to and rejected by a host of other drug companies as being completely infeasible.

So when Pharmacia finally agreed to pay for the rights to Bito’s patent, they took on an expensive risk that, some estimated, had less than a 5% chance of achieving success. Pharmacia assumed the difficult task of developing a brand new synthetic molecule that would have all the benefits described by Bito, but at the same time would not have the prohibitive side effects. There was no assurance at all that such a molecule could ever be developed, and the cost of searching for one would dwarf the cost of purchasing Dr. Bito’s compound in the first place.

If such a thing turned out to be feasible, then the company then would have to conduct painstaking and extraordinarily expensive human research trials, and if successful, would then have to shepherd their new compound through a time-consuming and costly regulatory gauntlet – which explains why the vast majority of promising new drugs fail to ever gain FDA approval. That their efforts were ultimately successful does not diminish the fact that, when Pharmacia agreed to invest the time, money and opportunity cost to develop Dr. Bito’s discovery, the company was committing itself to an expensive and extremely risky proposition, with no assurance of making a profit or even recouping their losses. It was, in fact, a very long shot.

The folks occupying Wall Street ought to remind themselves that the cool products they are using each day (such as the iPhones they use to organize their flash demonstrations) all came about because the profit motive – and only the profit motive – encouraged some entrepreneur to risk his/her time, treasure, and sacred honor on some new idea. And for each risk-taker who becomes a millionare or billionare, thousands of others achieve only modest success – or fail altogether. (That’s why it’s called “risk.”) But the lure of big profits drives the whole system, and accounts for American progress.

Bito’s (tax supported) idea was a promising one, but the challenge of developing that idea into a product that was useful to patients and that could be brought to market was very expensive and highly risky. Pharmacia took on that risk (all of which was borne by its shareholders, and not by taxpayers) only after difficult, internal corporate soul-searching. If not for the prospect of making enormous profits if this risk worked out, the company (like several other drug companies did in this particular instance) certainly would have walked away.

Before 1980, it is likely none of this would have happened. The Bayh-Dole Act of 1980 was passed expressly to encourage the further development of federally financed, university-based basic research. Until then, a large proportion of basic university research was never “translated” into useful medical products. Such translation of basic research was recognized by Congress to benefit society not only by advancing the practice of medicine, but also by stimulating the overall economy. So industry was actively encouraged to take on the risk of developing promising ideas that came out of federally-funded research. And the profit that greeted successful enterprises was designed to be the one thing that would lure industry into taking that risk.

So when the Times “discovers” a company “profiteering” from work done with tax dollars, it should not be a revelation, nor should it be an unmistakable sign that the company is inherently evil or dishonest. Nor does the company’s activity in this regard give us a justification to arbitrarily restrict its profits. Rather, that’s simply the deal we taxpayers (through our elected officials) have made with the drug industry. We made this deal because we felt it would benefit American society, the American economy, American patients, and quite probably, us as individuals. Of course, if we want to change that deal now, it is within our rights to do so.

Without Bayh-Dole, perhaps patients with glaucoma would still be getting surgical therapy and wearing those coke-bottle eyeglass lenses instead of just using eyedrops. And if we wish to allow the Central Authority to put the brakes on such medical advances (ostensibly to prevent unseemly profiteering, but actually to stifle medical progress), we certainly can. It’s how covert rationing works.

But we shouldn’t vilify the drug companies for taking us up on the deal we offered them, back when we were thinking more clearly.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Theory A:

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

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

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

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

Theory B:

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

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

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

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

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

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

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

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

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

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

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

Just last week, DrRich wrote a post explaining why medical screening tests, under our new paradigm of centralized healthcare, will always be found to be ineffective and harmful. Therefore, it will be the job of the United States Preventive Services Task Force (USPSTF)*, after making a great show of examining randomized clinical trials as if the result is not a foregone conclusion, to declare such tests useless.

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*Regular readers will recall that the Obamacare legislation has transformed the USPSTF from its former status as a mere (one might say milquetoasty) advisory board, which made recommendations on preventive health that doctors and patients could take or leave alone, into an extraordinarily powerful GOD panel (Government Operatives Deliberating) that determines, definitively, which preventive services are to be covered and not covered by private insurers, Medicare, and Medicaid.
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DrRich thought his observation would be viewed by many as a bit “out there,” and that proponents of Obamacare would accuse him (as they so often do) of being paranoid and reactionary. So imagine his surprise when, just yesterday, the New York Times published a “news analysis” which aggressively begins selling the public on that very notion – that medical screening tests are, by and large, a bad thing to do.

Even DrRich thought the Progressives would be somewhat circumspect about breaking such remarkable and counter-intuitive news to us in the great unwashed – especially considering that they have just spent the last three decades teaching us just the opposite.  But then he recalled their smooth, unapologetic and entirely unremarked transition, around twenty years ago, from sounding the alarm about global cooling to catarwauling about global warming.

And he reminded himself that when you are a Progressive, history always began 10 minutes ago.  And this turns out to be a great convenience.

In this case it is particularly convenient, when you consider the passionate declarations by Ms. Pelosi and others in 2009 that the watchword of Obamacare – indeed, the very key to the dramatically lower costs we would realize with this new legislation – would be “prevention, prevention, prevention.”

It is always risky to speculate on what is actually going on in Ms. Pelosi’s head, but certainly the public health experts who helped devise Obamacare understood the truth all along.  Namely, it is axiomatic that medical screening tests will always, without exception, cost the healthcare system far more money than they can ever save the healthcare system. And therefore, medical screening tests will have to be suppressed – which is precisely why our new healthcare law provides the mechanism for doing so.

While readers should never doubt DrRich, he is aware that, sadly, many do.  And so it may be necessary to review why screening tests are invariably a money-losing proposition:

• The screening tests themselves are often expensive.
• Screening tests often produce false positive results, so additional (often invasive and always costly) testing will need to be done to confirm or deny the diagnosis.
• If the diagnosis is made, treatment will be applied which is often dreadfully expensive.
• The diagnostic testing is often “too sensitive,” such that it may make a positive diagnosis for a very early condition that, if it had been left alone, may not have done serious harm. The cost of treatment will therefore be wasted.
• The screening test, the confirmatory tests, and the treatments that will be applied as a result of screening all carry the risk of complications, and the treatment of these complications can be extraordinarily costly.
• If the patient’s life is saved by the screening test and subsequent therapy, that patient (who is often an Old Fart like DrRich) will persist, for several more years, to soak younger, worthier Americans for Social Security and Medicare payments; and worse, will ultimately develop some other expensive medical problem everyone else will have to pay for.

Q.E.D.

The fact is, the best we can hope for from medical screening tests is that they might save a life here and there, which is hardly a public health victory. But whether they save a few lives or not, they’re inevitably going to cost us a lot of money.

And clearly, from the public health standpoint, a standpoint from which we’re paying for all healthcare collectively from pooled resources (and working hard to deny people the legal right to spend their own money on their own healthcare), it makes no sense to do screening tests.

Screening tests only make sense to the individuals who are at risk for the medical condition being screened, not to the collective.

The New York Times goes on at length to explain how screening for early cancers causes harm and inconvenience for many people in order to help a few. It mentions several of the points in DrRich’s bullet list above. It quotes several public health experts who, shaking their heads sadly, allow as how perhaps the medical profession has “oversold” screening tests in the past decades. These experts lament the fact that the public will need to be re-educated about the limitations and the harm being done by these tests. The Times worries that, perhaps, people will think the new de-emphasis on screening tests is related to healthcare costs, when nothing could be further from the truth.  The worthlessness of screening tests is a new revelation, made clear by recent clinical trials. What can we do but follow the science?

DrRich is not arguing that medical screening tests are invariably a good idea. In fact, he has just given his readers an entire list of reasons they are often not a good idea.

What he is arguing is that the whole framework for our current debate over screening tests is wrong.

The proper way to deal with the imperfections of screening tests is as follows. We should carefully explain to each individual who is a candidate for screening (because they are at risk for the medical condition being screened), all of the risks of embarking on a screening pathway – the potential discomfort, inconvenience, medical risks, and costs of the screening test, of the possible follow-up tests that may be required, and of the treatments that may become necessary if the testing is positive.  The individual can then weigh these negatives against the possibility of failing to discover a treatable disease while it is still treatable. And, taking into account everything that people take into account when making such momentous personal decisions, the individual can do what they believe is right for them. And either decision – to have or not have the test – would be reasonable, rational, and evidence-based – for that individual.

But we are arguing this question as if taking individual preferences into account is not even on the table. We are arguing as if we must make a sweeping decision regarding screening – yes or no – that will apply across the board, to all Americans, regardless of how they would personally weigh the relative risks and benefits.

We are arguing in this way because that’s precisely the approach that Obamacare has codified into law.  Medical decisions from now on will be centralized, and not individualized.  The GOD panelists will determine which decision is best for the collective. And what’s best for the collective is best for us individuals.

But the “screening test debate” graphically illustrates a truth that modern medical ethicists at least implicitly (and often explicitly) deny: What’s best for the collective is NOT always what’s best for the individual. And when we must only make medical decisions collectively, individual Americans will be systematically harmed. And that includes, according to the USPSTF’s own documentation, several thousand women and men each year whose early, currently treatable, but ultimately lethal breast and prostate cancers will no longer be detected early enough to do any good.

DrRich thinks these individuals should be given the opportunity to consider their options regarding medical screening, and make the choice that’s right for them. Progressives – especially the GOD panelists, the public health experts, and most of the American media  – do not.

That’s the debate we should be having.

The United States Preventive Services Task Force created another hub-bub recently when they released their latest, updated recommendations on whether men should routinely have PSA testing for the early detection of prostate cancer. The USPSTF’s recommendation was simple and straightforward: No.

News reports on this new recommendation have fairly accurately portrayed the arguments on both sides. Proponents of PSA testing are in an uproar because prostate cancer kills many men, and its early detection makes it easier to treat. Without PSA testing, the early detection of prostate cancer is difficult and often impossible. But those siding with the USPSTF point to randomized clinical trials showing no significant reduction in mortality in populations of men who have had PSA screening, and further, that men who have PSA screening end up having a lot of very unpleasant and expensive medical procedures which can leave them with life-altering side effects.

DrRich is by no means an expert on prostate cancer or PSA testing, but as it happens he is an American male who is within the age group addressed by this new recommendation. So he indeed has a legitimate interest in whether the USPSTF has made a wise decision or not.

To help him decide whether this new recommendation is a reasonable one, DrRich has gone to the source: to the document published by the USPSTF itself in announcing its new recommendation. Helpfully, the USPSTF has laid out in detail the specific clinical studies it relied upon, and the rationale it used, to synthesize the results of those studies into a concrete recommendation.

The USPSTF document points out two major conclusions which can be gleaned from the medical literature on PSA screening. First, when PSA screening is applied to large populations of men, it is difficult to demonstrate a reduction in mortality. Of two large clinical trials comparing men randomized to PSA screening to those randomized to “standard care,” one found that PSA screening yields a relatively small but statistically significant reduction in cancer-related deaths, but the other showed no mortality benefit. So, given a large population of men eligible for screening, doing PSA testing appears to yield a benefit that is either small or non-existent. And as a result, from a public health standpoint a recommendation to do widespread PSA screening is simply not justifiable based on current evidence. And this finding accounts for the USPSTF’s new recommendation.

But the second major conclusion that is revealed by the medical literature is that, for men in whom screening has actually detected early prostate cancer, subsequent treatment significantly reduces mortality. This result addresses one of the big questions often raised about early detection of prostate cancer, namely, whether the cancers detected by PSA screening actually require treatment. Many of these early cancers apparently never cause death, so many have speculated that “watchful waiting” might be a reasonable course of action rather than aggressive prostate treatment. But the USPSTF’s review of the relevant studies shows that when early-stage prostate cancer is identified, the best clinical trials available show a significant reduction in cancer-related death and all-cause mortality with either surgical prostatectomy or radiation therapy.

As the backdrop for these two major conclusions, the USPSTF strongly emphasizes the drawbacks of PSA screening. This screening often leads men to experience some very bad outcomes from prostate biopsies, or from therapy for prostate cancer. The very nasty complications resulting from these procedures are all too frequent, and are very difficult to even think about let alone experience. Furthermore, pursuing all those  positive PSA tests is extraordinarily expensive for the healthcare system. The reasoning offered by the USPSTF in making their new recommendation relies heavily on the price which men must pay, in terms of complications, in pursuing the results of a positive screening test.

DrRich has long been disturbed by the state of the art of both prostate cancer screening and prostate cancer treatment, by the lack of obvious progress in improving these things, and by the seeming complaisance with which many urologists seem to accept the status quo. PSA screening appears far too sensitive (too many false positives, leading to too many biopsies). Prostate biopsies often yield both false positive results (detecting cancers that are probably clinically meaningless) and false negative results (missing cancers that are clinically important). And the numerous treatments available for treating prostate cancer (all of which are very unpleasant) have not been rigorously compared, leaving the various “camps” of urologists to argue that their pet treatment is the best one, and all those other urologists have their heads up their ass.

All this confusion and uncertainty places the patient faced with the prospect of whether to have a PSA test, or worse, with newly-diagnosed prostate cancer, in a complete quandary, and apparently with no objective means to resolve what he ought to do next. But despite all these shortcomings, the urology community has aggressively turned PSA screening and the cascade of uncertainties (and resultant procedures) that flow from it into a burgeoning industry, to the extent that one must wonder how badly these specialists want to clarify the current muddle. And for this reason, it is difficult to take the loud objections being made by the American Urological Association against the USPSTF’s new recommendations very seriously.

So from a public health standpoint, the USPSTF recommendations on PSA screening seem reasonable to DrRich.

However.

DrRich keeps coming back to the second major conclusion from the USPSTF’s analysis of the medical literature on prostate cancer screening: Even with all the drawbacks associated with PSA screening, and even with all the conjectures about whether these early prostate cancers really need to be treated after all, it turns out that if prostate cancer is detected by some screening technique, then treating that cancer saves lives. And DrRich notes that while the USPSTF dutifully describes this result in the body of their report, they do not mention it in the Abstract of their report, and they do not seem to have given it much weight, if any, in their final recommendations.

But it seems to DrRich that this is an important result, and ought to be taken into account. It should not be simply brushed off as irrelevant, or unworthy of notice. It begs to be explained.

How can it be that, on one hand, offering PSA screening to a large population of men does not seem to result in much overall mortality benefit, whereas on the other hand, if you do find prostate cancer when you screen for it, then treating that cancer significantly reduces mortality?

Most likely the explanation lies in the dilution effect. The moderate (but statistically significant) benefit of treating early prostate cancer is washed out when those patients are included in a much larger population of men who are eligible for screening, and who may or may not have prostate cancer, which may or may not be detected adequately by current screening techniques, and if it is detected may or may not be treated.

To see how such a dilution effect might operate, let’s consider seat belts. Everyone knows that seat belts save lives. So let’s do a study to prove it. One way to do this would be to compare the mortality rates of people who are in automobile accidents, according to whether they were or were not wearing seat belts. Odds are it would be fairly easy to show a mortality benefit with seat belts. But now let’s compare the mortality rate of all drivers over a 5 or 10 year period according to whether they were wearing seat belts, regardless of whether they were ever in an automobile accident. DrRich suspects you would not be able to demonstrate a mortality benefit with seat belts in this second study.

The PSA screening studies that the USPSTF relied on to make their PSA recommendations are analogous to this second seat belt study. The prostate cancer treatment studies that did show a mortality benefit are analogous to the first seat belt study.

Please note that DrRich is not comparing PSA screening to wearing seat belts. Wearing seat belts does not lead to a lot of unnecessary expense, nor does it create life-altering side effects. PSA screening, given the state of the art, is neither inexpensive nor benign.

But despite its major drawbacks, PSA screening does detect early prostate cancer. And if you measure outcomes from the point where the prostate cancer is actually diagnosed (instead of from the point where you decide to do PSA testing), survival is measurably increased by its early detection and treatment.

So the dichotomy is explained. From a public health standpoint, where you have to decide what the result will be on a large population of individuals if some screening test is implemented, it does not make sense to do PSA screening. But if you are an individual who might have prostate cancer, in whom the early detection of that cancer might save your life, then it might make sense to do the PSA screening. (Whether it does or not depends on how you, the individual, assign relative weights to the notion of dying from prostate cancer vs. the inconvenience, expense, pain, and possibly horrible side effects from PSA testing and what it might lead to.)

So while from a public health standpoint it would be a mistake to recommend widespread PSA screening, from an individual standpoint either decision – to have or forgo PSA screening, depending on how you yourself weigh the tradeoffs – would be entirely reasonable.

But individuals are not allowed to decide this for themselves. This is no longer the kind of decision which individual doctors and patients are supposed to be making any more. In fact, it is now illegal to do so.

And this, Dear Reader, describes the problem with the USPSTF decision on PSA screening. For, in fact, the USPSTF is no longer making mere “recommendations,” which doctors and patients might take into account if they wish as they decide whether some preventive healthcare measure is right for an individual patient. Rather, the USPSTF rulings now determine whether you and I, as individuals, will or will not receive that preventive measure.

Obamacare, which is now the law of the land, makes the USPSTF the final arbiter of which preventive services are to be covered by private insurers (Section 2713), by Medicare (Section 4105), and by Medicaid (Section 4106). Only those that have achieved a grade of A or B by the USPSTF will be covered. And if you believe you will be able to purchase for yourself PSA screening (or any other medical service which Obamacare has decided not to cover) you have not been paying attention. Perhaps you can do so today (if you’re not on Medicare or Medicaid), but probably not for long.

What all the news outlets have forgotten to mention, in their coverage of the PSA controversy, is that the USPSTF has been officially converted from a panel that simply makes recommendations which doctors and insurance companies can take or leave alone, into a panel that determines definitively what is covered and what is not – and indeed, into the chief tool by which our leaders will seek to withhold expensive preventive services.

And while in the particular case of PSA testing, he is not particularly sorry to see the new USPSTF recommendation, DrRich submits that, given the general nature of medical screening tests, it is child’s play to set up a clinical trial that would “prove” (given the expense of the test, the false positives, the false negatives, the side effects of the test itself, the side effects and expense of the follow-up tests needed to see whether a positive screening test is truly positive, the expense and side effects of the treatment that will be used if the diagnosis is actually confirmed, the relative efficacy and inefficacy of that treatment, not to mention the dilution effects of having to screen a large number of individuals to find the relatively few who actually have the condition of concern and will benefit from its treatment) that there is no preventive screening test you could name that produces an overall benefit to the population.

DrRich has long predicted that the brilliant people in our news media will be continually “surprised” each time some heretofore sacred medical screening test is declared by the all-powerful USPSTF to be, after all, useless.

This being the case, can we just stop pretending that Obamacare is all about prevention, disband the USPSTF altogether, stop funding any screening tests whatsoever and any research being done to develop new ones, and call it a day? That would be much more transparent, not to mention cheaper, than stifling preventive medicine in the painfully slow and deceptive way we are doing it today.

A recent article in the New York Times discusses the growing controversy regarding whether nurses who have earned a doctorate degree in nursing practice ought to be addressed, by patients or others, as “doctor.”  The article touches upon several salient aspects of this controversy, but unfortunately does not resolve any of them.

According to the article, most doctors think nurses – even ones with advanced degrees – should not be awarded this honorific. Only physicians ought to be referred to, in any clinical setting, as “doctor.”

The reason, of course, is entirely altruistic. If the nurses are called “doctor,” it will confuse patients; they won’t know what’s going on, or who’s in charge. This kind of reasoning is entirely consistent with physicians’ well-known and unremitting efforts to make sure every patient understands exactly what is going on, at all times. Clearly, nurses calling themselves “doctor” will undermine such noble efforts.

There are other issues to consider. The Times portrays Dr. Roland Goertz, chairman of the board of the American Academy of Family Physicians (and presumably a doctor of medicine, but this is unspecified), as fretting that, should nurses be allowed to wrest control of the title “doctor” from the real doctors, the real doctors would experience a “loss of control of the profession itself.”

Dr. Kathleen Potempa, president of the American Association of Colleges of Nursing (and presumably a doctor of the nursing kind, but also unspecified) counters that nurses are getting doctorates not to take over the healthcare system or screw with doctors’ heads, but merely to boost their education and stay current. There is, she says, a lot for nurses to learn about these days.

But despite such soothing words from one of nursing’s luminaries, the Times notes that doctors remain alarmed. Nurses are really getting their doctorate degrees, physicians happen to know, to boost their credentials to practice independently – making their own diagnoses, initiating their own treatment plans, writing their own prescriptions, &c. Several states already allow them to do so. Louis J. Goodman, chief executive of the Texas Medical Association, is not fooled: “This degree is just another step toward independent practice.”

But the Times article ends with another demurral from Dr. Potempa: “Nurses are very proud of the fact that they’re nurses, and if nurses had wanted to be doctors, they would have gone to medical school.” (As if, DrRich can hear a few of his colleagues muttering, they could have gotten in.)

So, as DrRich says, the New York Times succeeds in rubbing some of the sore spots created by this controversy, but does not resolve anything. In fact, the article merely dances around the real issue, and leaves it entirely untouched.

You are therefore fortunate, Dear Reader, that you have DrRich to explain the whole matter to you. In fact, here are the six things you really need to know about the doctor-nurses controversy:

1) Nurses who decorate themselves with a doctorate degree in nursing practice have every right to refer to themselves as “doctor,” just as any other doctor in any other field has that right. DrRich was reminded of this fact several years ago, when he was severely admonished at a parent-teacher conference by his child’s history teacher for failing to address her as “doctor.” (This was after DrRich had ascertained that this person could probably not name a single event in American history that had occurred prior to 1860. But then, her degree was in “education,” rather than in the subject matter she taught.) And consider this: there are “doctors” wandering our streets whose degrees are in fields of endeavor whose names end in the word “Studies.” If these souls deserve to be called “doctor,” then nurses – who actually know a lot of very useful things – certainly do.

2) It is not the nurses’ fault that the doctors of old, when they finally became tired of being referred to as “barbers” or “chirurgeons,” and wanting a more distinctive name for themselves, commandeered the generic and widely-used title of “doctor.” No doubt they were very impressed with themselves at the time for having gained an education beyond that necessary to create a decent tonsure, but still. It is as if football players had decided to usurp the term “athlete” as referring only to themselves, and then complained when race car drivers began calling themselves the same thing. (The football players would have a point, of course, but on the whole their behavior would be unreasonable, not to mention unseemly.)

3) It seems just a tad disengenuous for physicians to complain because nurses calling themselves doctors might confuse some patients. Doctors themselves have not been particularly assiduous about disabusing their patients of various confusions. Doctors have yet to explain to their patients, for instance, that according to recently adopted precepts of medical ethics, they are obligated to covertly ration their medical care at the bedside. As a result, patients still think their doctors’ primary obligation is to them. This sort of “confusion” seems far worse, to DrRich, than a little confusion about who is a doctor and who is not. (Besides which, evidence suggests that many patients will always labor under the notion that all female health professionals are nurses, and all males are doctors – and so their confusion about who is who is pretty standard stuff.)

4) DrRich knows that you family practitioners out there have bigger things to worry about, but what the heck is the story with Dr. Roland Goertz*, chairman of the board of your professional society? Can it be he’s actually worried that nurses calling themselves doctors will lead to doctors losing control of their profession? What control is that? Gentlemen and ladies, you have elected a chairman who thinks that you family practitioners still have control of your profession! What are you people thinking?

____

*DrRich notes that Dr. Goertz is aptly named. The original, according to the Song of Roland, also sacrificed himself fighting a futile rear-guard action against vastly superior forces.

____

5) Dr. Potempa, president of the American Association of Colleges of Nursing, seems like a very reasonable person, and perhaps doctors (the physician kind) might be able to work with her. But DrRich has noticed that there are several different professional societies representing nurses, and some are less mild-mannered and less “reasonable” than others. The nursing organization which perhaps most directly represents those kinds of nurses whom doctors are most concerned about (i.e., nurses who become “doctors” and then want to be addressed that way) is the American College of Nursing Practitioners. The ACNP is much less demure than is Dr. Potempa’s organization about its long-term goals, which it has publicly expressed in a Strategic Plan published in 2005. Anyone examining this plan will note right away that it has been published in ALL CAPS, which, by tradition, indicates a shouting, in-your-face, screw-you sort of an attitude. In this manifesto, the ACNP states (among other things) that “INTERDISCIPLINARY NON-HIERARCHICAL TEAM CARE IS THE HIGHEST QUALITY OF CARE” (i.e., we’re not taking any guff, or orders, from you know-it-all doctors, rather we will practice as fully independent agents); and declares that their goals will not be met until nurses are “PRACTICING WITHOUT RESTRICTION IN EVERY SECTOR OF HEALTHCARE DELIVERY” (i.e., there are no limits to our scope of activity). Overall, this document is breathtaking in its breadth, straightforwardness, and attitude. This Strategic Plan, DrRich points out to his physician friends, reveals what the nurse practitioners are really up to.

And it’s just what you thought.

6) There is an overriding fact that renders all of the above entirely moot. It does not actually matter what doctor-nurses call themselves, or even that there is such a thing as doctor-nurses. It does not matter that the ACNP appears to be a predatory organization. It does not matter that Dr. Goertz may suffer from an acute lack of clues, or that Dr. Potempa seems like a nice lady.

None of this matters, Dear Reader, because Obamacare, the law of the land, has promulgated a new definition of Primary Care Practitioner. By law, today, physicians who practice primary care medicine, and doctor-nurses, and nurse practitioners (not to mention various other forms of non-physician medical personnel), are all PCPs. They are all equally qualified under the law.

It is a done deal. Only the details need to be worked out.

It is not convenient to acknowledge this fact. Primary care physicians and their professional organizations would rather not think about the implications. It means that the American Academy of Family Physicians is fundamentally an obsolete organization, as are its officials, such as Dr. Goertz. It means nearly the same for the American College of Physicians. Neither of these organizations is about to admit that. Furthermore, if this fact were to be acknowledged by the academic programs which are training our primary care physicians, they would become obligated to inform their applicants that the 8-10 years of medical training they are signing up for will place them in the same position, legally speaking, as a nurse practitioner (or, if they want to cushion the blow a little, as a doctor-nurse). This is truly an inconvenient truth. So it is being publicly ignored.

And so primary care doctors, and their professional organizations, go on pretending that the big issue facing primary care doctors is what these new-style PCPs will call themselves. And they are happy to fulminate about that issue to reporters from the New York Times. It seems safer than facing the truth.

But the truth is still the truth, and only the primary care doctors who face up to it will stand a chance of bucking the system, and maintaining their professional standards.

DrRich has heard several primary care physicians argue that their training is just so much better than the training of a doctor-nurse that it’s absurd to suppose those lesser professionals can offer equivalent care. This would certainly be true if primary care doctors actually did the things their training prepared them for. But if they continue following the path the system has laid out for them in recent years – avoiding the management of hospitalized, acutely ill patients altogether; seeing the outpatients who constitute their entire practice at a rate of one per 7.5 minutes; spending that 7.5 minutes making chits on Pay for Performance checklists from On High; sending anyone who actually seems a little sick to the emergency room or to a specialist – it is actually difficult to see what the big drop-off will be if doctor-nurses are doing the job.

When DrRich’s 15-year-old automobile displays some horrible new symptom, he wants a well-trained and experienced mechanic to diagnose the problem and fix it the right way. But if he’s only taking it to one of those 10-minute places for an oil change and a filter, it’s fine with him if the technician just learned the job last Tuesday from Stu. Primary care doctors have allowed themselves to be converted into Jiffy Lube. The training advantage they have over doctor-nurses matters less and less.

The Central Authority is assembling panels of experts to determine which medical decisions are to be made under which circumstances for which patients, and all it asks of doctors is to follow their instructions to the letter. Further, the Central Authority has determined that doctor-nurses will be very, very good at following those instructions – better than physicians, almost without a doubt. Indeed, the nurses’ lesser training – enough to allow them to recognize common conditions, and also enough to teach them that medicine is extraordinarily complex and there’s a lot they don’t understand and never will – is aimed at rendering them satisfied to comply with the directives handed down by panels of experts, and to be very thankful they can do so. Their reduced training is a decided advantage to the Central Authority.

To the Central Authority, the role of an ideal “practitioner” will be much better filled by a nurse, whose training is brief, to the point, focuses on following treatment plans, and is not burdened by centuries of professional pride and embarrassing oaths to dead Greek gods.

Primary care doctors who still value their professional pride, oaths, &c. had better light out for the territories while they still can, and quit worrying about the doctor-nurses (who soon enough will have big problems of their own).

Doctors need to face what is happening to their profession, and avoid getting distracted by battles over nomenclature. If they want to maintain their professional integrity, they will need to clearly distinguish themselves from the checklist checkers and the guideline followers, and demonstrate how the individual expertise and the personalized care they offer will be a big advantage to many patients.

If primary care doctors believe they really do add value to patient care over and above whatever nurses can provide, then they had better learn to articulate exactly what that value is. And once having articulated it, they will need to organize themselves to deliver and market that value, at a reasonable price, to the people they expect to pay for it.

And the “people they expect to pay for it” had better be their patients – because the Central Authority and other third party payers have made crystal clear precisely what they want, expect, and will tolerate from a PCP. What that is, of course, is complete compliance with central directives, and an end to the annoying expectations physicians have traditionally expressed for individual decision-making.

And as for those within the Central Authority, DrRich humbly suggests they carefully read the ANCP manifesto, and ask themselves whether the object of their affection, when finally won, is going to prove quite the demure, compliant little partner they’ve been pining for all this time.

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.

DrRich deeply, humbly, sorrowfully and most abjectly apologizes.

When one fancies himself an ironist, a satirist, one must be very, very careful. The ironist attempts to illustrate the limitations of a point of view with which he or she strongly disagrees, by purporting to adopt that point of view, and then taking it to its logical and outlandish extremes, in order to demonstrate how absurd it is at its root. But the irony only works when the people who actually hold that absurd point of view would somehow be brought up short, or embarrassed, or angered by it.

“That’s not what we’re saying at all!” is the response the ironist hopes to elicit. Because once the opponents make that response, it then becomes their obligation to attempt to explain  exactly how their point of view does not logically lead one to such absurd, counterproductive, or stupid conclusions. And, if the ironist is correct, his opponents will be unable to do so, and will be left with name-calling, labeling, and vituperation – which, by any objective measure, is a form of capitulation.

And judging by the names he has been called, the labels that have been hung upon him, and the vituperations with which he has been pasted, DrRich has generally been quite satisfied with the results of his occasional attempts at irony and satire.

But his most recent effort has failed, and failed badly, and for this he is most grievously regretful.

For, no sooner had DrRich penned his most recent post patiently explaining why Governor Christie is simply too fat to run for president, than sundry Progressives (the very target of DrRich’s badly misjudged piece) began publishing exactly the same opinion, using the same arguments which DrRich had considered to be the fruits of irony. In fact, one or two of them actually predated DrRich’s publication date. (Had he known this, he would have aborted his effort altogether.)

Regular readers will know that DrRich has long railed against the demonization of obesity, and has liberally employed irony to do so. By ostensibly supporting those who would cast the spirits of fat people into herds of swine, DrRich has (until now, he thought) effectively shown the moral bankruptcy of the anti-obesity movement.

The anti-obesity movement, DrRich thinks, is like many of the crusades which have been taken up by Progressives (for instance, the environmental movement and the deification of “diversity”), in that it takes what at its root is a good idea (in this case, the unhealthfulness of extreme obesity), and converts it into a sledgehammer with which to beat the populace into compliance with top-down, expert-driven controls over individual freedoms.

It is an unavoidable result of publicly funded healthcare that any behavior of any individual which increases the likelihood they will need “extra” healthcare services, will potentially rob those of us who do not choose such unhealthful behaviors of medical services which might otherwise be available to us. Therefore, when healthcare is entirely publicly funded, it is inevitable that individual behaviors will need to be controlled by some Central Authority.

The obese are the chosen first target for asserting such controls. To render those controls publicly acceptable, it is necessary to reduce obese individuals to a state in which limiting their individual freedom of action is widely considered acceptable. That is, they need to be demonized.

So we ignore that gross obesity is almost always genetically mediated, greatly enhanced by environmental factors largely out of an individual’s control. We choose to blame obesity entirely on a lack of self-discipline, on a fundamental failure of the individual himself, and we behave as if this failure renders fat people beneath contempt. We do not do this with smokers, or drug abusers, and even seem reluctant to do it with child molesters. But fat people are fair game.

So when DrRich said that Governor Christie is just too damned fat to be a candidate for president, because fat people are lazy, slothful, lethargic, and self-indulgent; and because allowing a fatty to aspire to such a high position would create the false impression that obese people are worthy of any consideration whatsoever, and would make people think that the obese ought to have the same individual freedoms as the rest of us; and when DrRich concluded that Christie’s candidacy would therefore be a serious setback to the Progressive program (which is to say, controlling individual behaviors for the great benefit of the collective); and when he therefore urged the Governor to stay in New Jersey, except perhaps to occasionally cross the state line just long enough to stock up on Philly cheesesteaks; he thought he had taken the thing to the outlandish extremes customary to a master of irony.

So imagine DrRich’s dismay when, just after publishing his diatribe, he saw Michael Kinsley’s article on Bloomberg also declaring Christie too fat to be president. The reason? Because “a presidential candidate should be judged on behavior and character, not just on policies.” Fat people, Kinsley elaborates, are a “perfect symbol of our country at the moment, with appetites out of control and discipline near zilch.” In other words, fat people have shown themselves, by their very obesity, to be entirely unworthy characters, and being unworthy, should not aspire to the presidency  – or presumably, to any other position of importance.

Then there’s Eugene Robinson of the Washington Post, who agrees that Christie’s weight should prevent him from running, but does so for kinder reasons than Kinsley’s. Robinson is worried about the Governor’s health. That’s kind of him, but he also can’t help remarking that the “obesity epidemic” is costing the government a lot of money, and indeed, he implies that people like Governor Christie are responsible for the massive federal deficit. Since Christie is likely to remain fat whether or not he runs for president, when one parses Robinsons’ sentences one can only conclude that his real argument is that it would simply be wrong for a person whose behavior is costing us so much money, and is thus endangering the future of the nation, to aspire to the presidency.

So there you have it. Actual Progressives are making the very same arguments for Christie to stay out of the race that DrRich made, in what he thought was a brilliantly ironic blog post.

DrRich’s description of how the obese are regarded is no longer an outlandish extrapolation of prior statements and policies. It’s now official. The party line on obesity is this: Fat people have chosen to become fat, and by so doing, have overtly displayed, for everyone to see, their utter lack of discipline, self-control, self-regard, and concern for their fellow citizens. So the obese have no reason to expect the same rights, privileges, freedoms and considerations enjoyed by us thinner (or at least, less fat) citizens.

DrRich unwisely tried to satirize the Progressive position on obesity, without realizing that this position had already “progressed” well beyond irony. His readers ought to expect more from him than this, and so he abjectly apologizes.

DrRich only asks his readers to please take into account, when you consider the Progressives’ actual behavior and their own words, how very difficult it is becoming to satirize them. DrRich may soon be reduced to straight reporting.