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.

Ten: The Right To Bear Salt

Nine: About Those Doctor-Nurses

Eight: The Four Ways To Reduce Healthcare Spending

Seven: On Killing The Elderly

Six: The Real Utillity of “Never Events”

Five: Who Writes Those Clinical Guidelines, Anyway?

Four: DrRich Explains The Right To Healthcare

Three: It Is Your Duty To Maintain Wellness

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

One: Why People Think Obamacare Has Death Panels

Read them and weep.

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

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

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

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

So let us begin.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Say, whatever happened to those steel mills, anyway?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Everyone agrees that national spending on healthcare is on a trajectory to bankrupt America during the lifetimes of even Old Farts like DrRich. And therefore, most folks* agree that we ought to do something to reduce our national spending on healthcare.
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*The reason it’s only “most folks” who agree is that, apparently, some folks are still partial to the Cloward-Piven strategy, and continuing to spend on healthcare as we are doing today is the quickest and surest way to get there.
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Unfortunately, our national “discussion” on how to achieve this reduction in healthcare spending has devolved into a spectacle of accusations and counter-accusations, vituperation, abuse, and scurrility. Accordingly, not much useful has so far been achieved. Worse, the back-and-forth contumelies lobbed by the various interest groups in this national discussion have created a general sense among the public that the problem is so confused and chaotic, so rifled by conflicts of interest, and so very complex, as to be fundamentally unsolvable.

This general sense of despair is entirely unnecessary. DrRich is here to assure his readers that the problem of healthcare spending is not only solvable, but that it is destined to be solved – and within the lifetimes of many of us.

Furthermore, there are four ways (and only four ways) in which this inevitable reduction in healthcare spending can be achieved. By knowing these four methods of solving the problem, it is entirely possible – as we listen to all the debating, fighting, and reciprocal castigations, aspersions, distortions and lies being cast by and amongst the various interest groups – to understand which method is actually being espoused by which parties. If you happen to be partial to one method over another, this kind of knowledge can help you determine to whom you should offer your support.

And so, in the way of providing yet another remarkable service to his readers, DrRich is pleased to describe the four ways to reduce healthcare spending.

Method One: Make all healthcare spending the responsibility of the individual.

This is the method by which most of mankind has paid for healthcare for all but a few decades of the millions of years we have graced (or plagued) the planet: If you want or need healthcare (and if it exists), simply pay for it yourself. Proponents of this method offer two general arguments to support their position – an ethical one, and a practical one.

It is fundamentally unethical to insist that an individual’s healthcare services must be provided by others – claiming that healthcare is somehow intrinsically different from any other product or service which the individual may wish to acquire (such as food, clothing, housing, and iPADs) – because insisting on such a thing will place an unjustifiable burden on one’s fellows. Much of a person’s health (and therefore, of a person’s healthcare needs) is determined by lifestyle choices, so it is only right and proper for the individual to bear responsibility for those choices. Demanding that one’s fellow citizens take that responsibility for such personal choices is fundamentally unethical – and requiring them to do so will inevitably lead to tyranny by some Central Authority.

Method One also holds that, by returning the purchase of healthcare back into the realm of actual market forces, the laws of supply and demand will determine which services are actually needed, and what the rightful price for those services ought to be. So from a practical standpoint, Method One will at last recruit the efficiencies of the marketplace into the healthcare system, and bring the cost of healthcare services down to a level which individuals can actually afford. (And if people can’t or don’t want to pay for healthcare services, they are more likely to begin making lifestyle choices that will lower their odds of having to do so.) But whether or not individuals can afford medical services, at least the spending on those services will no longer be the burden of society – and the fiscal doom we now face will be cured.

Opponents of Method One point out that, inevitably, there will be individuals – and likely many, many individuals – who simply will not be able to afford to pay for healthcare services which are needed, and which are readily available for a price, and will therefore suffer preventable pain, disability, and death. Without some kind of public support for healthcare, heart-rending tragedies will abound, our civilization will become coarsened, anger will build, and insurrection will become a constant threat.

Method Two: Make all healthcare spending the responsibility of a Central Authority.

Method Two holds that, for straightforward ethical reasons, healthcare is a fundamental right; that whether one receives a healthcare service – a service that can relieve pain or prevent disability or death – ought not to depend on one’s ability to pay, but that healthcare services ought to be equally available to everyone. The only way to achieve this goal is to collectivize and centralize healthcare decisions and healthcare spending.

For proponents of Method Two, healthcare services are indeed fundamentally different from all other human needs – food, clothing, etc. – since the kind and the amount of healthcare services one needs are much less a matter of individual choice, but are foisted upon one by fate. Burdening individuals with the need to pay for such arbitrary and uncontrollable costs is not only unethical, but destabilizing.

Requiring individuals to pay for their own healthcare is destabilizing because, if a person’s lifetime of work and saving can be wiped out in an instant by an unexpected illness, people will be much less willing to work hard, take risks, and otherwise engage in the economic activities that drive our society. “Healthcare security,” which can only be provided by collective efforts, is thus necessary to a robust and sustainable civilization.

The methods by which healthcare costs can be controlled under a centralized system are straightforward. Obamacare, for instance, does so by explicitly empowering a (nearly) all-powerful Independent Payment Advisory Board (IPAB) with all macro-level healthcare spending decisions. Furthermore, “guidelines” promulgated by various other expert panels will control spending at a more granular level, by determining which specific services doctors will be permitted to offer to which patients, and under what circumstances. Doctors will be strictly held, under the threat of criminal prosecution, to these guidelines. Finally, recognizing implicitly that many healthcare needs are indeed determined by individual lifestyle choices rather than purely by chance, public health experts will advance enforceable policies that will determine what and how much we eat, when and how long we sleep, what products we acquire and how we use them, and what activities we are permitted to perform where. (The public health experts are off to a very good start in this effort!) If everyone within the healthcare system (and in our society) will simply follow the multitudinous directives laid out by the legions of sanctified experts, costs will at last be contained, and all will be well.

Regular readers will understand that there is no need for DrRich to reiterate in any detail here the arguments that have been raised by opponents of Method Two. These arguments can be summarized simply as follows: Method Two inevitably leads to tyranny.

Method Three: Provide strictly limited public support for basic healthcare services, with individuals responsible for the remainder.

Method Three attempts to combine the benefits of Methods One and Two, while avoiding their major disadvantages. Method Three recognizes that paying for all of one’s own healthcare is beyond the means of many individuals, and that therefore a modern, civil society ought to provide at least some healthcare to at least some of its citizens. At the same time, Method Three recognizes that the public funding of all healthcare is beyond the means of society, will inevitably lead to ruin, and that (both for these practical reasons and for ethical reasons) individuals ought to be responsible for paying for at least some of their own healthcare.

Numerous configurations are possible under Method Three. The key to controlling costs is that the dollars which society will spend on healthcare for individuals must be strictly defined and strictly limited, and cannot be open-ended. Method Three ought to assure that individuals will have ready access to, and the means to pay for, basic healthcare services, and that the chances of being financially ruined by a catastrophic illness are very low, but at the same time that most individuals should not and cannot rely entirely on public funding for their healthcare.

Examples of “Method Three” configurations include the detailed three-tiered solution that DrRich proposed in his book; the Ryan plan, which would limit Medicare expenditures by providing seniors with a fixed amount of money – on a means-tested sliding scale – with which to purchase their health insurance of choice; and, at least arguably, the original conception of Medicare, in which it was at least legal, if not expected, for seniors to pay for additional, non-covered medical services with their own funds (an option which is now very difficult, and often illegal).

How is the battle shaping up?

As DrRich sees it, Method One is simply a non-starter. For all practical purposes, and for good or bad, we moved irreversibly beyond a purely self-pay healthcare system over 60 years ago. So the real battle is between Method Two and Method Three. The feud between these two methods is going to be a bloody one.

The key difference between these two methods – both practically and philosophically – is whether individuals will be permitted to pay for at least some of their own healthcare with their own money. For reasons DrRich has laid out previously, it is imperative under Method Two that all healthcare decisions and all healthcare spending be centralized. There can be no compromise on this.  The moment a compromise is made, we will inevitably wind up under a Method Three healthcare system.

Proponents of Method Two do not like DrRich (and have said so many times), because he has concluded (and often repeats) that, viewed objectively, the only logical reason these people fight so hard to keep individuals from being required (or even permitted) to assume at least some financial responsibility for their own healthcare, is that their actual prime objective must be something other than to fix the healthcare system and control healthcare expenditures. Rather, their actual prime objective must be, and can only be, to centralize the control of our society. The healthcare fiscal crisis is merely the most expedient vehicle to achieve this prime objective. (Progressives mean well, as DrRich has said many times, but their plan for a perfect society is always based on the need for all of us in the great unwashed masses to subsume our individual prerogatives in favor of the dictates of the enlightened leadership. Unfortunately, history teaches us that this plan never works out well.)

If this battle is ever resolved, therefore, it will hinge on whether individual Americans retain the legal right to purchase healthcare services with their own money. DrRich admits that this conclusion, regarding the essence of our ongoing healthcare debate, is not one which has been remarked by many other commentators on healthcare policy. It is, nonetheless, the case. An objective observer who pays close attention to the machinations of the nameless bureaucrats who are currently writing the rules and regulations under which Obamacare will finally be prosecuted will see that it is so.

What about Method Four?

There is little reason to spend much time discussing the fourth and final method for controlling healthcare expenditures. Nobody is a proponent of this method, so nobody discusses it. However, Method Four, at this moment, seems to be the most likely outcome. Indeed, at this moment it is our default method of choice.

Method Four is formulated as follows: Our skyrocketing healthcare expenditures are the chief driver of our national debt. Our national debt burden, unless we get control of it by controlling healthcare expenditures, will inevitably destroy our civil society. At the same time, our modern, sophisticated and very expensive healthcare system utterly requires a complex, modern, organized, high-tech society in which to function.

Therefore, our skyrocketing healthcare expenditures ultimately provides its own cure. Once society collapses, “healthcare services” will revert back to the roots-and-poultices methodologies that served mankind so well for millions of years. And healthcare, as well as other modern geegaws like cable TV and the Internet, will no longer be a fundamental human right, but will become a mere afterthought (if a thought at all) in a more primitive kind of society where life is nasty, brutish and short.

So, not to worry.

As President and sole member of Glorious Old Farts of America (GOFA), DrRich is acutely aware of the many ways our healthcare reformers – even prior to the birth throes of Obamacare – have subtly laid the groundwork for ushering us old timers to Our Great Reward in an efficient and cost-effective manner. Whether or not Obamacare has death panels, if you are an old fart you’d better pay attention to what our compassionate leaders have in store for us.

Can Advance Directives be Salvaged?

How To Sell Assisted Suicide

Ethicist-Assisted Suicide

On Killing the Elderly

Why People Think Obamacare Has Death Panels

In the epic debate that has played out recently between Shadowfax and DrRich over the transcendent implications of the IPAB (Independent Payment Advisory Board), Shadowfax accused DrRich of being one of those unsophisticates who refer to the IPAB  as a “death panel.”

Nothing could be further from the truth. DrRich does not use – has never used – the term “death panel” to refer to any of the multitude of expert commissions created by Obamacare, whose charge will be to dispassionately examine the scientific evidence in order to determine which patients will get what, when and how. These bodies, in fact, will be explicitly aiming to optimize the medical outcomes of the entire population (titrated to the amount of money we’re allowed to spend on healthcare), and not actively prescribing death for anyone.

Judging from the histories of governments which have adopted a collectivist philosophy, if death panels should appear on the scene they will not be aimed at determining which patients may live or die. That job, of course, will fall to the doctors at the bedside, who will offer or withhold medical services according to the dictates (i.e., “guidelines”) handed down by those sundry expert commissions. Rather, any death panels which eventually materialize will more likely be aimed at keeping those doctors themselves (and any other functionaries whose job is to do the bidding of the bureaucracy) in thrall.

So why has the term “death panel” caught on to such an extent that conservatives so often use it as shorthand to express what they see as the “sense” of Obamacare, and Progressives so often use it to accuse rational and mild-mannered critics of Obamacare (such as DrRich) of belonging to the Neanderthal persuasion?

While most would blame Sarah Palin for coming up with this unhelpful phraseology, it is DrRich’s view that President Obama himself must carry at least an equal part of the blame. If Progressives have not created death panels, they at least created the environment in which those words, when Ms. Palin first uttered them, immediately caught fire.

As readers will recall, Ms. Palin first used the fateful words, “death panels” as the Obamacare legislation was being slowly and painfully shoved through a surprisingly reluctant Democrat Congress. And as a result she caused many of our more complacent legislators to abruptly bestir themselves into a higher state of arousal, if not outright agitation. Palin’s accusation caught more than a few of them utterly unawares, and embarrassingly flatfooted.

They felt, no doubt, like they were in that dream where you unaccountably find yourself naked in a crowd. But this time, rather than reaching to hide their sadly exposed nether parts, they reached instead for their pristine copies of the monstrous Obamacare legislation which had been laid before them, and which they famously (and understandably and logically) never read. One could almost pity them, desperately rifling through the 2700 virgin pages, muttering to themselves, “Death panels? This damned thing has death panels?”

But in fact, their initial instincts were correct as regarded the advisability of actually reading the legislation. There was in truth no reason for them to waste their time. DrRich has subsequently read large swatches of the thing, and he can assure one and all that it was not designed for reading, comprehensibility, or (for that matter) imparting any actual information of any sort.

And besides, Obamacare contained no death panels, so had they read the bill they would not have discovered any. (In their state of sudden and stark panic, however, our newly-aroused legislators quickly moved to strike the section the bill that provided for end-of-life counseling, which, of course, had nothing to do with death panels.)

The very notion of death panels seems to have many supporters of Obamacare nonplussed. How can someone as inarticulate and obviously illiterate as Sarah Palin get away with accusing our highly-educated healthcare reformers of setting up such a thing as death panels?  And even more perplexingly why did so many Americans believe her – even, apparently, hundreds of thousands of Americans who had been enlightened enough to vote for President Obama less than a year earlier?

DrRich thinks it is this: When Sarah Palin said, “death panels,” she was dropping one last, tiny crystal into a supersaturated solution. Her words took what had been an amorphous and even chaotic sense of unease about healthcare reform, and immediately crystallized it into an organized latticework of directed rage and fear. So the real question is not how Sarah Palin came to be savvy enough to know just the right words. (Progressives know that even a distinguished panel of monkeys, given enough time and enough typewriters, will eventually produce King Lear.) Rather, the real question is: What put the rabble in such a supersaturated state to begin with? Why did the absurd-on-its-face idea of “death panels” so resonate with them? What made those words galvanize their shapeless disquiet into a solid mass of resistance?

DrRich is very sorry to have to tell his friends of the Progressive persuasion the sad truth. For it was President Obama himself who created this circumstance. Sarah Palin may have first named the death panels, but before she ever thought of the phrase the President had already described them in detail.

During his first year in office, President Obama offered several homilies relating just what a “death panel” would look like. He described their function, how they would operate, and who they would target. Perhaps the most instructive example is the one he gave on ABC television during his June 24, 2009 National Town Hall meeting.

DrRich refers, of course, to the famous question put to him by the granddaughter of a 100-year-old woman who had received a pacemaker. The questioner pointed out that her grandmother had badly needed this pacemaker, but had been turned down by a doctor because of her age. A second doctor, noting the patient’s alertness, zest for life, and generally youthful “spirit,” went ahead and inserted the pacemaker despite her advanced age. Her symptoms resolved, and Grandma was still doing quite well 5 years later. The question for the President was: Under Obamacare, will an elderly person’s general state of health, and her “spirit,” be taken into account when making medical decisions – or will these decisions be made according to age only?

President Obama’s answer was clear. It is really not feasible, he indicated, to take “spirit” into account. We are going to make medical decisions based on objective evidence, and not subjective impressions. If the evidence shows that some form of treatment “is not necessarily going to improve care, then at least we can let the doctors know that – you know what? – maybe this isn’t going to help; maybe you’re better off not having the surgery, but taking the pain pill.”

DrRich will give President Obama the benefit of the doubt regarding his suggestion that a 100-year-old women who needs a pacemaker might be better off with a pain pill. Mr. Obama is not actually a doctor, and cannot be expected to understand that using a “pain pill” to treat an elderly woman who is lightheaded, dizzy, weak and possibly syncopal because of a slow heart rate might justifiably be considered a form of euthanasia rather than comfort care. DrRich does not believe the President was intentionally suggesting the old woman’s death should be actively hastened by means of a pain pill. Indeed, given that repeated falls from lightheadedness would likely have led to a hip fracture, a pain pill might eventually have been just the thing for granny had the pacemaker been withheld.

Still, President Obama’s clear and unflinching answer in this case tells us several important things. 1) Under Obamacare, there will be at least one panel, or commission, or body of some sort, that is going to examine the medical evidence on how effective a certain treatment is likely to be in a certain population of patients. 2) This, let’s call it a “panel,” will “let the doctors know” whether that treatment ought to be used in those patients. (“Letting the doctor know” is a euphemism for “guidelines,” which itself is a euphemism for legally-binding and ruthlessly enforced directives.) 3) “Subjective” measures ought not to influence these treatment recommendations. Non-objective parameters – such as the doctor’s medical experience, intuition, or personal knowledge of the patient; or the patient’s “spirit,” or will to live, or likelihood of tolerating and complying with with the proposed proposed treatment; or even extenuating circumstances that might increase or decrease the success of the proposed treatment – simply cannot be evaluated or controlled by expert panels, and thus must be discounted. 4) But since our government is a compassionate and caring one, and wishes to reduce unnecessary suffering, palliative care will be made available in the form of pain control, even while withholding potentially curative care.

What the American public accurately heard the President say was that we will have an omnipotent “panel,” acting at a distance and without any specific knowledge of particular cases, that will tell a doctor whether he/she can offer a particular therapy to a particular patient – or whether, instead, to offer a “pain pill.”  His description of this process, repeated with variations over the next several months in several venues, obviously made quite an impact on the people.  Of course, Mr. Obama is widely known to be a gifted communicator.

In any case, all that remained was for Sarah Palin to give the President’s panel a catchy name. And when she did, the American people knew exactly what she was talking about. They knew, because President Obama himself had been spelling it all out for them in plenty of detail for six months.

Indeed, it seems to DrRich that, if not for President Obama’s having so carefully laid the groundwork,  Palin’s accusations of “death panels” would have fallen flat. It would have been regarded by most people as the absurdity that Progressives insist that it is, rather than the epiphany it turned out to be.

Progressives who strenuously object to its usage in reference to the expert commissions created by Obamcare can blame Sarah (or, for that matter, DrRich) if they want to – but by all rights they should actually be taking up the matter with their dear leader, who is the chief source of the misapprehension, if misapprehension there be.

DrRich’s most recent post attempted to show how the creation of the Independent Payment Advisory Board (IPAB) – the panel created by Obamacare that (as President Obama himself indicates) will be primarily responsible for reducing the cost of American healthcare -  nicely illustrates the Progressive mindset. That Progressive mindset, DrRich maintained, is reflected in the degree of power and breadth of control granted to the IPAB, in the coercive process under which the IPAB was created and its powers granted, and in attempts to bind future Congresses from amending those powers.

DrRich did not imagine that Progressives would like his formulation very much. But as always, DrRich offered his analysis in the hope of engaging readers – friend or foe – in a fruitful exchange of ideas.

And accordingly, DrRich is gratified that the venerable blogger Shadowfax has seen fit to offer a pointed (though to be sure, rather brutal) rebuttal. While the nature of his rebuttal does not exactly invite a civil exchange, DrRich (in the spirit of furthering understanding amongst our mutual readers) will attempt to reply in a collegial manner.

Anyone who has read Shadowfax’s post will know that it would be all too easy for a back and forth to descend into heaped vituperations. Shadowfax begins his presentation, after all, with a scathing ad hominem attack on DrRich’s person. He speculates as to whether DrRich is a confabulist or a conspiracy theorist, and proposes, as the qualities which define DrRich, only the following: “laziness, ignorance, misinformation, or untreated paranoid psychosis.” Along the way DrRich becomes also a partisan hack, deceitful, hysterical, and a purveyor of fluff.

For several reasons, DrRich will not respond in kind. First, when he joined his high school debating team in 1965, one of the first things DrRich learned is that when one has induced his opponent into an ad hominem attack, one has already won the debate. Second, by virtue of his original post on the IPAB, DrRich started it – and when one starts it, one invites and ought to expect a vigorous response. Third, DrRich does not take this ad hominem attack at all personally, so does not feel compelled to return the favor. DrRich comforts himself with the knowledge that Shadowfax does not know him personally, and is confident that if he did, he would be entirely won over (as is everyone) by DrRich’s charm, his joie de vivre, his incisive humor, his charisma, and above all, his humility. And finally, DrRich chooses to view this personal attack clinically, as doing so makes it plain that by its very nature, Shadowfax’s reply is itself entirely illustrative of the Progressive mindset. (In other words, Shadowfax has inadvertently succeeded in reinforcing DrRich’s chief message.)

DrRich will return to this latter point in a short while.

For the record, DrRich does not attribute any negative personality or motivational traits to Shadowfax, and indeed, chooses to believe that he is basically a nice person. (Even if he did not believe it, DrRich would not say so. DrRich notes that Shadowfax is the parent of three children, and he would hate to have those tykes see their Dad publicly subjected to personal insults – despite the fact that Shadowfax neglected to consider the fragile sensibilities of DrRich’s own young ones before publicly besmirching his intellect, motives and psychological health.)

To his credit, the bulk of Shadowfax’s rebuttal (after having dismissed DrRich’s person as being beneath contempt) has to do with matters of fact, or rather, with matters of interpretation of fact. For DrRich thinks he and Shadowfax are surprisingly close on the facts themselves. It is in interpreting the implications of those facts that the difference appears.

And here is where DrRich must diverge for a moment to re-introduce his Theory of Progressive Thought. He has explained this theory at some length in the past, and subsequently has further developed it on several occasions. In so doing, DrRich has explicitly insisted that it is just a theory.  It is a proposed framework for explaining the multitude of difficult-to-explain behaviors we have witnessed from Progressives during the last 120 years. In laying out this theory, DrRich has invited one and all to point out its weaknesses, and to suggest a better theory if they have one. Since DrRich himself does not like the implications of his Theory of Progressive Thought – given that Progressives are now running the show – he will, as he has said more than once, be delighted to abandon it for a better theory, should one come to his attention. But in order to be designated a “better” theory, it will have to explain real-world Progressive behaviors even more effectively than does DrRich’s.

Contrary to Shadowfax’s accusations, DrRich does not impute negative motives to Progressives. Indeed, fundamentally Progressives are motivated by a deep desire to achieve societal good. They are dedicated to achieving a society in which all people – whatever their disadvantages and limitations may be – will thrive equally, or as equally as possible. DrRich stipulates that this goal is inherently a good one.

Furthermore, Progressivism being a product of the Age of Reason, Progressives sincerely believe that such a goal is within the reach of mankind. It can be achieved by careful observation, analysis, and rational solutions systematically applied. And therefore it ought to be the goal – rather, it ought to be the duty – of mankind to strive to thus implement effective solutions to society’s problems. And so, Progressives believe that the goal of mankind ought to be to continually progress toward solutions to ALL society’s problems, and hence to strive unrelentingly for a “perfect” society.

And that’s the theory. Contrary to Shadowfax’s accusation, there is no imputation of evil motives in this theory. Indeed, Progressives, as a group, tend to be motivated primarily by compassion for their fellow humans – at least as a starting position.

Unfortunately for everyone, there are two major problems inherent in Progressive thought. First, the rational analyses and the carefully planned solutions to society’s ills which are prescribed by Progressivism are almost always beyond the ken of your average member of the great unwashed. So designing and implementing the Progressive program inevitably relies on a cadre of “specialists,” a class of elites who have the right stuff (the right intelligence, the right education, the right knowledge, the right motivation, &c.) to do the job.

Thus the rational solutions to society’s problems which are offered up by the Progressive program are inevitably to be provided by an enlightened corps of elites, and accordingly, it is the duty of the average citizen (i.e., the rest of us) to cooperate with these handed-down solutions, for the overriding benefit of the whole. Otherwise, the Progressive program cannot succeed.

This fact places Progressivism fundamentally at odds with the Great American Experiment, that is, with a system of government which at its core maximizes the autonomy of we individuals to do as we please, and which allows us to succeed or fail based on our own actions, to the extent that our actions do not infringe on the rights of others. Thus, there is a natural and unavoidable tension between the kind of broad, centrally planned solutions which Progressivism inevitably offers up, and the severely limited sort of central authority provided by our founders.

The second great problem with Progressivism is even more intractable. It is that the kind of societal solutions dreamed up by Progressives invariably require individuals to sacrifice their freedom of action, to one degree or another, for the sake of what the elite planners have determined will benefit the collective – and in so doing, Progressive solutions always seem to require a fundamental change in human nature. That is, the Progressive program requires individuals to subsume their own individual interests to the interest of the collective.

Such a change in human nature will never be forthcoming, and this fact, in the end, will always defeat Progressivism (though often not before a lot of damage is done). Inevitably, the recalcitrance of substantial proportions of the population to their brilliant solutions drives Progressives, once they have been in power for a while, to great frustration, and finally, to drastic repressive action. A history of collectivist governments during the past 100 years amply demonstrates this ugly fact.*

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* According to R.J. Rummel in his book Death by Government, during the 20th century the world’s governments killed four times as many of their own people, on purpose, as were killed in all wars combined.
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With this brief review of DrRich’s Theory of Progressive Thought (and its implications), let us now quickly visit the differences in how DrRich and Shadowfax view the facts as they pertain to the IPAB.

Is the IPAB designed to function as a dictatorial entity? Shadowfax argues that since it will not be utterly impossible for Congress to overturn the mandates handed down by the IPAB, it is therefore not dictatorial. And from a strict definition of the word he is correct. But DrRich holds that the language of the law (which, to halt the IPAB mandates on healthcare spending, requires a supermajority of the Senate to a) block those mandates, then b) come up with its own cost cutting scheme that will achieve equivalent results),  is meant to achieve for the IPAB at least near-dictatorial powers. Even Shadowfax allows this possibility: “The argument is that the IPAB becomes a de facto dictatorial board, because the bar is set too high to override its recommendations. We will see, I suppose.” This unelected panel* of experts will determine who gets what, when and how, and it will be exceedingly difficult (but admittedly not impossible) for Congress to have much to say about it. Therefore, Obamacare explicitly attempts to severely limit the prerogatives of the peoples’ representatives to control the ability of this unelected panel of experts to determine the medical destiny of Americans.

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* Contrary to Shadowfax’s unnecessarily gratuitous implication, DrRich has not referred to the multitudes of expert panels created by Obamacare as “death panels.” To do so would make DrRich seem as unsophisticated as Ms. Palin. Rather, DrRich has referred to them by the much more accurate name of GOD Panels (Government Operatives Deliberating).
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Is the IPAB designed to be an immutable panel? The plain language of the law very clearly attempts to render it exceedingly difficult (if not impossible) to change the IPAB provisions of Obamacare, thus revealing a wish on the part of its creators to render the IPAB an immutable entity. DrRich agrees with Shadowfax that, in truth, no Congress can actually bind all future Congresses down into perpetuity. But the language of the law clearly expresses a desire to do so. Shadowfax makes some sort of argument to the effect that the phrase “It shall be out of order” gives Congress a pathway to changing the IPAB provisions. And it is true that, under Roberts’ Rules, when a chairman declares some procedure to be “out of order,” there are provisions for appealing that ruling and rendering the thing back into order. But this provision is almost exclusively used to determine whether a member can speak or not. In contrast, the immutability language in Obamacare purports to create a LAW (rather than an ad hoc chairman’s ruling), which declares any action to alter the IPAB to be perpetually “out of order.” DrRich can find no parliamentary procedure addressing this remarkable and audacious circumstance.

In any case, even if the immutability language pertaining to IPAB turns out indeed to be something that can be by some manner overcome, as Shadowfax insists, that fact is not obvious. It has also escaped at least some U.S. Senators, who have interpreted the language the same way that DrRich has. And whatever the parliamentary options that may or may not come into play, the clear intent of the language in this provision is to greatly reduce the ability of future Congresses to alter the IPAB provision (if not actually render it immutable). Once again, this attempt is perfectly consistent with the all-consuming desire of Progressives to implement their expert-controlled programs with only minimal interference from the people (or the peoples’ representatives).

Does the IPAB already have the power to restrict private as well as government healthcare expenditures? Here, Shadowfax appears to concede the point, more or less, and adds that the idea “strikes me as a GOOD thing.”  DrRich has described in great detail how and why our Progressive healthcare reforms will inevitably restrict (and is already attempting to  restrict) the ability of individuals to pay for their own healthcare with their own money. And now, the IPAB (this very powerful and nearly-immutable panel of experts) has apparently been granted the authority to take charge of this important goal.

The bottom line, regarding these points of fact, is that DrRich and Shadowfax disagree less on the fact themselves than on the implications of those facts. We differ greatly on whether these features of the IPAB – dictatorial (or quasi-dictatorial) powers, immutability (or quasi-immutability), and the power to restrict private healthcare spending – are good things. Shadowfax explicitly believes that they are.

DrRich’s view, of course, is that these legislated features of the IPAB are perfectly consistent with, and even predicted by, his Theory of Progressive Thought. And that was indeed the whole point of his original post. Furthermore, based on the recent history of collectivist governments and where they invariably lead, DrRich does not believe this to be a good thing.

Before ending, DrRich must return to the ad hominem attack launched against him by Shadowfax which, DrRich submits, also perfectly reflects the Progressive mindset.

Almost invariably, once the Progressive elite have settled upon their scientifically-based, rational, centralized solution to some dire societal problem (such as healthcare reform), their thinking regarding the unwashed masses goes through a stereotypical evolution. At first they always believe (their proposed solution being so scientifically sound, so logical and so well-thought-out), that by delivering a carefully packaged explanation of their solution, the people will enter into paroxysms of delight.  When the people do not react as expected, and indeed express apprehension or anger at what is being proposed, the Progressives will tell themselves that they must not have explained their solution well enough (but what can one expect, after all, when dealing with the great unwashed?) – and then they will arrange to implement the solution anyway (using whatever machinations and maneuverings are necessary to pull it off), confident that once the teeming masses see the incredible benefits that will accrue to them when the program is actually under way, they will at last display those belated paroxysms of delight. But then, when the program is actually implemented and the people are still complaining about it – or more likely, making their complaints more than merely vocal – the Progressives will begin culling out some of the more prominent troublemakers among them and make examples of them. And if that fails to quell the complaints of the masses, the leaders of collectively-oriented governments have been known to move past disappointment and frustration and into a state of wrath – and this (again, DrRich is simply referring to history) is where the real atrocities have taken place.

The evolution of the Progressives’ frustration regarding the public’s acceptance of Obamacare has moved past the “we can educate them” phase, and past the “we’ll go ahead and implement it and then they’ll like it” phase. They will soon be looking for someone of whom to make an example.

Traditionally, they will diagnose such troublemakers as being either misinformed (stupid), motivated by bad intentions (evil), or mentally deficient (crazy). And (again, historically), the solution to which the dissenter is subjected depends on that diagnosis – typically a re-education camp, elimination, or commitment to a state-run mental institution.

DrRich simply notes that Shadowfax has reacted with distressing typicality to a loudmouth who is not going along with the program. He indicates that the only possible explanations for DrRich’s recalcitrance (since a logical objection is not a possibility) are “laziness, ignorance, misinformation, or untreated paranoid psychosis.” That is, DrRich must be stupid, evil or crazy. It only remains for Shadowfax to decide on which of these diagnoses is correct, so that the appropriate final solution can be prescribed.

DrRich stands by his original contention that the salient features of the IPAB, the manipulative and underhanded process which brought it to life, and now, the reaction of Progressives when they encounter people who complain about it, all perfectly reflect the Progressive mindset.

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This is the first in a series of articles on End-of-Life Care and Covert Rationing.  The second article can be found here.

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It is easy to have missed it, because it went by so quickly.

On January 1, the White House announced a new policy that would have paid doctors for discussing end-of-life planning during their Medicare patients’ annual “wellness visit.” Under this policy, physicians would be paid to encourage their patients to establish an advance directive, which would guide medical care if the patient became incapacitated from illness, and could no longer make medical decisions for him/herself.

But on January 5, the new policy was suddenly revoked. It was revoked, CMS lamely explained, because it had not been implemented using the correct process. But, as anyone would know who watched Congress make Obamacare the law of the land, this could not possibly have been the real reason.

The real reason, of course, has to do with the firestorm this new policy threatened to unleash, just as the House of Representatives was about to be taken over by the cretinous opposition party.

As regular readers will recall, the Obamacare bill originally included similar language on advance directives. Physicians were supposed to urge their patients, repeatedly if necessary, to establish advance directives, and their success in extracting advance directives from their patients was to be one of the “performance measures” by which doctors would be judged to be in good or bad standing with the Central Authority.

But then Sarah Palin said “death panels,” and a furor ensued. The provision on advance directives was quickly removed from the Obamacare legislation, as if Congress was admitting that Ms. Palin had been correct and they had been caught out.* Similarly, the effort last month to reinstate the provision failed to stick for fear of criticism at a bad time.

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*The original advance directive provision in Obamacare, of course, had nothing whatsoever to do with “death panels,” since there are no panels of any sort involved in establishing advance directives. Rather, the entities that some might call death panels, and which DrRich has chosen to call GOD panels (Government Operatives Deliberating) – that is, panels of distinguished experts that will determine, by means of “guidelines,” which patients will get what, when and how – remain fully operative within Obamacare.
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DrRich has nothing against advance directives, and indeed, thinks they are a good idea – in concept, at least. Advance directives allow patients to establish beforehand, usually by a written document, what kinds of medical treatment they would or would not want should they fall victim to a serious, life-threatening illness that leaves them unable to express their wishes. Advance directives are supposed to work by providing guidance to their physicians, who, in their fiduciary capacity, are charged with acting in the patient’s best interest.

A well-constructed advance directive allows patients to choose to spare themselves from demeaning, undignified, painful or otherwise undesirable medical procedures and treatments, should they become incapacitated at a later date. “Well-constructed” implies that the advance directives are clearly and concisely written, that they honor the ethical and legal norms approved by society, and that they provide the physician with clear guidance.

But it is more difficult to write a “well-constructed” advance directive than might at first meet the eye. The major problems are two-fold: Advance directives often express imperfect knowledge, and they are often imperfectly expressed. These limitations mean that in appropriately exercising an advance directive, often the physician cannot follow them to the letter, but must interpret them according to the circumstances at hand.

A healthy and relatively robust individual cannot always know how he or she will feel years into the future, when illness strikes and it is time to exercise an advance directive. Every doctor has seen critically ill patients who, despite having advance directives to the contrary, unhesitatingly choose to be attached to a ventilator when the time comes, for instance, rather than face certain imminent death. So experienced doctors know that advance directives do not always indicate what patients will actually choose to do when the time to make a choice is upon them.

They also know that, while conscious patients have the opportunity to repeal their advance directives, unconscious or incapacitated patients do not.** So, in exercising an advance directive, the conscientious physician interprets that directive in light of many other factors, such as, her personal knowledge of the patient, the opinions of family as to what the patient would want done, and the chances of a long-term recovery if the therapy being considered is used. Then she will negotiate with responsible family members an approach that appears to meet the patient’s presumed desires.

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**Conscious patients can repeal their advance directives in theory. DrRich has witnessed actual doctors, however, arguing vociferously against using a medical therapy that a sick patient now desperately wants, because years ago the patient signed an advance directive expressing aversion to that therapy.
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Therefore the advance directive in many cases is an important part of the decision-making process, but it is not the only part. The appropriate use of an advance directive requires the doctor to behave as a true patient advocate, to selflessly place the desires expressed in the directive in context with everything else that might affect the patient’s true and current wishes, and then make a recommendation that, to the best of his or her ability, honors those wishes.

Unfortunately, doctors can no longer act primarily as their individual patient’s advocate. Indeed, physicians are officially enjoined (by the New Ethics formally adopted by their own professional organizations) to give the needs of society at least equal consideration. And so, as has demonstrably happened with other “guidelines” in medicine, it is inevitable that advance directives will be reduced to a legal edict, which must be followed to the letter if the physician wishes to remain clear of the Department of Justice.

The likelihood that there will be no room for interpretation means that constructing just the right kind of advance directive for yourself – one that will be precisely suitable to any contingency that may occur – has become extremely difficult. If you get the details just a little bit wrong for the circumstances that actually arise, the price you pay may be very heavy. It would be better to have no advance directive at all than to have one that is misleading or ambiguous. Advance directives must be written with extreme care, and only after long, thoughtful consideration.

That is not how the government would have it, however. For many years now, the Feds, under the Patient Self-Determination Act, requires hospitals to inform patients about advance directives at the time of every hospital admission, and to invite them to sign one. To say this is a less than ideal time to implement an advance directive would be something of an understatement. Asking a patient to sign an advance directive at the time of hospital admission, often by including it in the pile of routine and mind-numbing legalistic documents which patients must sign if they want to receive medical care, and often with no more guidance than that provided by the admissions clerk (who might explain, “This tells the doctors you don’t want to be kept alive on a machine like a vegetable,”) tells us something about whether the true motive for advance directives is to protect the patient’s autonomy – or to reduce costs.

Having the discussion in a doctor’s office these days, sadly, might not be much better. The Central Authority knows that squeezing what really ought to be at least a 30-minute discussion into a 10-15 minute office visit already packed with Pay for Performance requirements (while providing the added threat of punishment if the physician fails to extract an advance directive from the patient), will yield, at best, a signature on a boiler-plate document.

But despite the slap-dash method by which such a document may be implemented, it is a document whose language – when the time comes – will be exercised with all the legalistic exactitude of a contract attorney by any doctor who knows what’s good for him.

DrRich thinks that Americans are right in being suspicious of the big push they are seeing to urge advance directives upon them. Invoking “death panels” in this regard is utterly inappropriate, but the end result will suffice. It is good that we have all been given pause.

Still, the concept of advance directives is a good one, and DrRich thinks most Americans might do well to have one. Despite the damage that is being done to them, DrRich thinks advance directives can be salvaged. To this end, DrRich suggests several steps we can all take in executing an advance directive that will actually do what we want it to do:

1) Don’t be pressured into implementing an advance directive by anybody whose career depends on keeping the Central Authority happy. Unfortunately, this likely includes your doctor if you are not paying your doctor yourself.

2) Don’t sign a boiler-plate document. These likely will have been drafted with the interests of the Central Authority in mind, with the help of very smart lawyers, and when these documents are called into use in all probability they will be interpreted for the convenience of the Central Authority.

3) Try to keep your advance directive from showing up in an electronic medical record. Write it yourself, and store it where your loved ones can find it when they need it. Give a copy to your spouse, your children, and perhaps (if you have a direct-pay doctor who works only for you) your physician. This way, since your advance directive will not be immediately available to hospital personnel if you are suddenly incapacitated, no unfortunate and irreversible decisions regarding the aggressiveness of your medical care can be made until your loved ones are notified.

4) Write your advance directive as a general guideline, with as few specifics regarding particular types of medical care as possible. You should assume that any type of treatment you mention in a negative light will be withheld under any and all circumstances, including circumstances you may not be aware of in which you would want that treatment.

5) You are not writing your advance directive for the doctors (it is most tragic that we can no longer trust doctors in this regard!); you are writing it to help your loved ones make the right decisions for you, perhaps despite the doctors. So your goal should be to clarify your general desires for your loved ones. Discuss your advance directive with your loved ones after you have written it, and ideally, before you have written it. Your written words will remind them of your wishes when the time is right.

Lest you think, Dear Reader, that  DrRich is merely being sarcastic  here (and why would anyone think so?), he is not. DrRich himself has an advanced directive that attempts to follow these rules. The document is stored at home with his important papers. Mrs. DrRich knows where to find it, and knows DrRich’s general feelings regarding these matters. With the guidance he has provided, DrRich trusts her and his children to make these important decisions for him. For anyone who is interested, DrRich’s advance directive is reproduced, in its entirety, at the end of this post. (The general language, which has been adapted and revised by DrRich for his own use, was originally suggested to him by a good friend who is a superb internal medicine practitioner.)

So. Advance directives are a very good idea, but unfortunately, have been identified by the Central Authority as a potentially powerful cost-cutting tool. Even before Obamacare, certain HMOs were refusing to reimburse hospitals or doctors that provided medical care that seemed to go against specific language contained in an advance directive. That, of course, was child’s play. Now that the Central Authority has gotten hold of them, advance directives will likely be treated the same way as other guidelines are now treated in medicine, that is, as edicts, and thus as vehicles for the criminal prosecution of medical personnel who deign to “interpret” them.

This means that if you wish to take advantage of the benefits which advance directives can provide, you will have to proceed very, very carefully.

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DrRich’s Advance Directive:

If I am able to communicate my wishes by any means whatsoever, then I wish to make my own decisions regarding my own healthcare. If, despite my ability to communicate, my condition makes it inconvenient to fully inform me of my situation and all my treatment options, then until such time as it becomes sufficiently convenient to do so, I want everything possible to be done to sustain my life and effect a recovery.

In the event of an incapacitating illness in which I cannot communicate, the basic guideline initially should be to do everything possible to sustain my life and effect a recovery.

After a reasonable period of time (in general, I would consider a week to be reasonable) if no progress has been made in the recovery of my mental function, and the likelihood of mental recovery is judged to be small, then withdrawal of life-sustaining care should be strongly considered. To help my wife and/or children with this decision, I would like to have an evaluation by a neurologist to help clarify the prognosis.

If improvement in my mental status has been made, then efforts to sustain my life and affect a recovery should be continued.

If at any point in my care there is a period of at least two weeks in which I am persistently unable to carry out meaningful communications sufficient to make my own wishes known (in the opinion of my family members and the neurologist), and the likelihood of mental recovery is judged to be small, then I would consider the withdrawal of life-sustaining care to be a blessing.

While DrRich is a conservative American, and has made plain the difficulties he has with the Progressive program in general and with Progressive healthcare reform in particular, at times he is forced to admit that, on occasion, the Progressive way of looking at the world has certain merits. And as DrRich contemplates a question that has been bothering him lately, a question that no doubt plagues many American physicians who (unlike DrRich) are still toiling away in the trenches, he finds that this is one such occasion.

That question is: Just who are the people writing all those clinical guidelines – the  “guidelines” physicians are now expected to follow in every particular in every case, on pain of massive fines, loss of career, and/or incarceration?

DrRich is quick to say that the act of creating clinical guidelines is not inherently evil, and indeed, back in the day when guidelines were merely guidelines (instead of edicts or directives that must be obeyed to the last letter), creating clinical guidelines was a rather noble thing to do.

But today, we have physicians clamoring to become GOD panelists (Government Operatives Deliberating). These aristocrats of medicine will render the rules by which their more inferior fellow physicians, the ones who have actual contact with patients, will live or die. Clearly positions of such authority will be very desirable, and so, as one might predict, they are being vigorously pursued. And we are seeing candidates audition for these panels with efforts ranging from amateurish to ruthless. It puts one in mind of the early-season contestants on “American Idol.”

We see them vociferously extolling, in every public venue they can find, the idea of “fly by wire” medicine, whereby every decision physicians make will be determined not at the bedside but by the best and the brightest experts, acting at a distance. The experts will distribute rules of action based on only the best scientific evidence (“best” being determined by those selfsame experts). The directives they hand down will be models of actionable simplicity,spelled out so unambiguously that even doctors born, raised, and trained in the Midwest or the South will be able to follow them.  (And if the doctors refuse to cooperate sufficiently, non-physician medical professionals will be able to do the job.) We see them writing scientific papers that spin the evidence in such a way as to generate conclusions which will be soothing to the Central Authority. We see them editing medical journals in order to make certain that the correct conclusions are published, and the incorrect ones are not. We see them taking control of professional organizations, and using their positions to promulgate changes in medical ethics that advance the Borg-ification of medicine, and to formally endorse Obamacare on behalf of American physicians who, for the most part, were against doing so.

These people have gained great prominence within our healthcare system, and practicing physicians will be dealing with them and the consequences of their actions for many years to come. While the natural impulse of us typical American doctors may be to simply marvel at the wonder of it all, shake our heads resignedly, and go about our increasingly distressing business, it may behoove us to take a closer look at these individuals, to attempt to understand them a little better. After all, their activities in the near future promise to greatly impact our lives, our fortunes, and our sacred honor.

So – who are they, anyway?

This, dear reader, is where the Progressive mode of thought comes in handy. DrRich refers, of course, to the Progressive doctrine of Diversity.

Diversity, for those who pretend not to know, is perhaps the chief mechanism by which Progressives attempt to control the behavior of the population.

Recall that the Progressive program is to create the perfect society. The Progressive elite know just how to do this, of course, but individuals within every population throughout human history have insisted upon acting in their own self-interest, which is counterproductive to the collective goal. In past efforts to perfect human societies, such individual recalcitrance has been dealt with by means of concentration camps and pogroms and the like. “Diversity,” we all should admit, is a much kinder and gentler approach to curing the problem of individualism.

Specifically, the doctrine of Diversity defines the range of permissible behaviors and thoughts for a given group of people within a society. The numerous celebrations of Diversity we see all around us invariably turn out to be strategies to reinforce those allowable ranges of thought and behavior. In this way, members of a particular group who begin behaving and thinking outside the allowable range can be quickly identified and dealt with, either through correction (which brings them back into the group), or through vilification (which marginalizes them). It is easy to become confused about this, since classically “diversity” means something other than “conformity.”  (As a general rule, if you want to know what Progressives are really up to, listen to what they say and then look to see if their deeds are actually working toward the opposite thing.  DrRich thinks that much of the time you will find that they are.)

In any case, while in general DrRich does not approve of Diversity as it is being practiced today, he finds that the concept might be useful in attempting to answer the question at hand.

Specifically, DrRich refers to his theory that physicians (like any humans) tend to end up in careers that best suit their underlying personalities and proclivities, and so physicians in a given specialty will tend to think and behave like other physicians within that specialty, and unlike physicians in other specialties. If this theory has any merit (and let us call it the Diversity Theory of Physicians), it will allow us to make some generalizations about the characteristics of individuals who have chosen specific kinds of medical careers. DrRich stresses that he is aiming to make generalizations only, and while those generalizations might help enlighten us to a modest degree regarding, say, what sort of physician will end up on the GOD panels, they can tell us nothing about particular individuals.

With that annoying disclaimer out of the way, let us examine some ways in which the DTP reveals Truth. An obvious example is the specialty of psychiatry, which tends to attract doctors who are, perhaps subliminally, concerned that they are just a little crazy themselves. As it happens, it often turns out they are correct. In DrRich’s experience, and in the experience of just about anyone who has encountered more than a handful of shrinks, these fine physicians, on average, display an astonishing degree of off-the-wall psychopathology. (Not that there’s anything wrong with that.)

Emergency room doctors have short attention spans and are afraid of commitment.

Endocrinologists get their jollies by sitting alone in cramped offices, parsing tremendous volumes of laboratory data from blood tests, which they claim reflect moment-to-moment variations in hormone levels, and from this arcane evidence are able to parse out (so they say) subtle glandular difficulties. If endocrinologists were not physicians they would be accountants; the more aggressive endocrinologists (who are identifiable by the dirty glance they give you if you happen to interrupt their lonely cogitations) might be forensic accountants. (How anybody could specialize in any organ that just sits there, perhaps secreting various invisible substances, but otherwise not doing anything whatsoever,  DrRich will never understand.)

Orthopedic surgeons are former jocks, or wish they were, and the ones who end up replacing hips in old ladies instead of patrolling the sidelines at college football games are often very frustrated individuals.

Party animals who manage to gain entrance to medical school often end up as anesthesiologists.

Cardiologists like to envision themselves (and would like others to envision them) as living on the edge. After all, they put catheters into damaged coronary arteries in patients on the brink of heart attacks, and, through their skillful manipulations, open those arteries and save lives. They are the extreme sportsmen of medicine, so they believe. But really, their jobs are ones of relative security, predictability and instant gratification. What they do in the cath lab actually is pretty rote, and it provides them with immediate, concrete results. They can even show the “before” and “after” pictures to the person they just saved, who will then heap praise and shed tears of gratitude upon them. But any time fixing a particular artery looks a little too risky, they call a cardiac surgeon right away. This pattern of behavior suggests to DrRich that their aggressive personnas and glory-seeking activities are actually masking an underlying insecurity.

It would not be fair of DrRich to psychoanalyze all these other specialists – who have done nothing to provoke him – without also doing the same for electrophysiologists. All electrophysiologists started out as cardiologists, of course, so they have that going for them. But to really understand electrophysiologists, one must invoke the principle of sublimation. To sublimate is to channel an underlying negative tendency to some activity that partially gratifies that tendency, but that is considered worthwhile by society. So, for instance, people with a tendency toward pyromania may become volunteer firefighters. People with sadistic tendencies may become prison guards. Foot fetishists can become shoe salesmen. Compulsive liars can become novelists.

Who, then, become electrophysiologists?

Back in the 1980s and 1990s, when DrRich was practicing, what electrophysiologists mainly did was to try to prevent sudden death in patients who had a high risk of dying suddenly from cardiac arrhythmias. And in order to find the optimal therapy for these patients, it was necessary to induce, intentionally and repeatedly, cardiac arrests under controlled conditions. This was done in an effort to find an antiarrhythmic drug that would prevent the induction of cardiac arrest. This behavior we euphemistically called “serial drug testing.”  Fortunately, this procedure is no longer necessary, since the implantable defibrillator has been perfected and is now widely available for high-risk patients (if you can get it paid for).

While it has been widely remarked that those early-day electrophysiologists were a very strange group indeed, most of us who did this serial drug testing ended up successfully absorbed into normal society, and today (as far as DrRich can tell) we are for the most part generally pretty harmless. But DrRich sometimes finds himself wondering what might have become of some of us (some in particular more than others) if we had not had this remarkable opportunity to sublimate what one might speculate to be some rather unpleasant tendencies. And what is to become of that young person today who has whatever those unfortunate tendencies might be, and who, 30 years ago, might have found release as an electrophysiologist? One must not think too deeply about this.

Let us now turn our attention to those would-be GOD panelists, and see if we can decipher what kind of people these might be. Admitting that what follows – and, for that matter, what has just been said – amounts only to an educated guess, DrRich submits that the GOD panelists are people you already know well, if you have worked within the American healthcare system.

These are the kids you knew in college who studied all the time and got straight A’s in all the hardest courses, buttered up their teachers, then aced their MCATs. For them the hardest part about applying to medical school was in deciding which of the many schools that accepted them they should attend. Likely, they chose one of the Ivy League ones. Their first two years of medical school – the didactic years – were much like their college experiences. They studied hard, aced all the exams, and were generally acknowledged by both faculty and peers to be at the very top of their class.

Then they reached their clinical years, and things changed. They still knew more information than anyone else, and in fact their information base continued to expand. They read all the journals, and could always quote new research findings chapter and verse. They could conjugate the Krebs cycle on demand (or whatever it is you do with the Krebs cycle), and could recite precisely which enzyme that new drug inhibited, and could say why doing so made it OK to eat pizza again.

But what they could not do was be a good doctor. They had no instinct for it; no ability to get the patients to tell them the important information; no ability to read a patient’s facial expression, or phraseology, or body language, those signs that reveal the real truth. They had no ability to discern useful information from the flood of partial and contradictory clinical evidence that is always pouring in from several sources. When time was of the essence, they had no capacity to figure out what was going on or what they should do about it. They could not adjust to changing clinical situations on the fly. In an emergency they were paralyzed, trying to match the quickly evolving situation in front of them with the static words on the printed page. And often they were klutzes.

They were perfectly cut out to learn medicine, but lousy at actually doing it. What was worse, some of their colleagues who were mediocre in the book-learning department suddenly blossomed into highly competent clinicians on the wards, and quickly became recognized as rising stars by attending physicians, while they themselves were repeatedly chastised, or ignored.

And it just wasn’t right. It just wasn’t fair. They had worked harder than everyone else, had twice the brains as those others, and had learned the material three times as well. But the way God set it up, they just weren’t good doctors.

Many of these unfortunate souls quickly left clinical medicine, and branched off into research, academics, or administration. Most of them did quite well for themselves, because they really are very smart. But they never really got over their frustration and anger over their unjust  failures on the clinical wards, a place where their obvious inferiors lorded it over them. They have now spent years engaging in cognitive dissonance, convincing themselves that their apparent failure was an illusion, merely a sign of having been subjected to the anti-intellectual, shoot-from-the-hip, do-it-quickly-and-make-more-money environment that is American healthcare. After all, how could they be sub-optimal physicians when they are clearly far more intelligent and knowledgeable than the supposed “stars?” If the healthcare system had been arranged differently, in such a way as to make the cowboys behave the right way, they would have proven themselves to be the best clinicians in the land.  It is a bitter, bitter pill.

These are the guys, DrRich thinks, who are chomping at the bit for the opportunity to sit on the GOD panels. They would dearly love the chance to utilize their superior intellectual firepower, to distill the clinical research data, to digest it painstakingly and thoroughly (not haphazardly and on the fly like those others), to put down on paper the RIGHT way of practicing clinical medicine -  and to have the authority to do it in such a way (backed up by the full force of the Central Authority) that those lesser doctors will HAVE to do it their way, at long last.

The point of all this psychoanalytic guesswork is to suggest that the GOD panelists, even the GOD panelists who are physicians, will have no sympathy for the idea that the practice of medicine should be individualized to any degree whatsoever. The idea of individualizing medical care, rather than practicing by formula from a book, is what caused these people the most uncomfortable moments in their professional lives. Far from being sympathetic to the idea, they will probably be more hostile to it than the non-physicians on the GOD panels. When somebody on the panel suggests that, perhaps, we should give the doctor a little more leeway on this particular issue, these physicians will speak up and say, “Listen. I’ve been there and you haven’t. These doctors don’t need any more rope, unless it’s to bind them even tighter.” They were themselves shown no quarter, in the tough arena of clinical medicine where outcomes (and not process or book knowledge) is the only mark of success, and they will offer none in their turn.

DrRich cannot prove any of this, of course. He is just theorizing, based on his own personal observations and prejudices, having observed many of these whiz-kids in his 25 years of teaching medical trainees, and watching where they wound up. He could, of course, be wrong.

In any case, for allowing him to carry on in this manner DrRich owes one more expression of gratitude to his Progressive friends, whose doctrine of Diversity supplies the necessary substrate, and the ethical “cover,” for mercilessly stereotyping selected groups of what otherwise might turn out to be individuals.

Regular readers will know that DrRich is not enamored with Obamacare. Further, they will recall that DrRich’s chief objection to Obamacare is that it codifies into law the final destruction of the classic doctor-patient relationship.

Under Obamacare, the physician is not only released from her fiduciary obligation to her individual patient (i.e., the obligation to place the interests of the patient above all other considerations), but is strictly forbidden from acting in accordance with it. Indeed, elaborate mechanisms are established to assure that physicians will follow the directives which are to be handed down from omnipotent and immutable government panels, directives which will be explicitly aimed at optimizing collective rather than individual outcomes. And whereas physicians have long been discouraged from making healthcare decisions based on individual considerations and needs, Obamacare makes doing so a felony.

Combine that fact with inevitable future provisions that will prevent doctors from opting out of the system, and patients from spending their own money on their own healthcare, and you’ve got a prescription for a healthcare system (and a society) that are somewhat less friendly to individual needs, and somewhat more tyrannical, than supporters of Obamacare have promised us.

So, as a matter of principle, DrRich is sympathetic toward the newly-elected (and newly-reformed) Republicans who promise they will introduce and vote on a bill to repeal Obamacare.

But let’s be realistic. Even the most zealous Republicans understand that any repeal bill that passes in the House will stall in the Senate, and if it does not, the President will veto it. Indeed, it is this comforting assurance, DrRich thinks, that will induce many Progressively-oriented Republicans to go along with a repeal vote in the first place. By voting to repeal Obamacare, frightened and disoriented Republicans can mollify the Tea Party, without risking an actual abolition of the new reforms. Because if Obamacare were somehow repealed – well, where would the Republicans be then?

The health insurance industry, however, is taking no chances.

DrRich will remind his readers that Obamacare never would have become law in the first place if not for the solid and unrelenting support of the health insurance industry. The industry’s support for Mr. Obama’s effort was unfaltering. And during the long and perilous process that finally brought Obamacare to the President’s desk, whenever the cause faltered and appeared to be lost, representatives of the insurance industry would rise up and take whatever strong and difficult action was needed to get it back on track.

DrRich will further remind his readers that the insurance industry did not support Obamacare out of any principle, or compassion, or any sense of what was moral or right. They did it as a matter of life and death – theirs. For the health insurance industry had run out its string, shot its wad, blown up its business plan, and had nowhere else to turn. It was Obamacare – and its soothing “promise” to allow the industry to survive in diminished form, as a government-controlled utility – that offered insurers their only visible path away from oblivion.

The insurance industry is not about to go back. Furthermore, unlike Nancy Pelosi, Harry Reid and even President Obama, the insurance industry is not satisfied to let the political realities of the day block the Republicans’ efforts at repeal. For all they know, nervous Democrats in the Senate who want to be re-elected in 2012 will allow the repeal bill to go to the President’s desk. Worse, unused to seeing Presidents willing to sacrifice themselves on the alter of principle, the health insurers, in their existential panic, must wonder whether even Obama might finally change his mind and decide that he wants to be re-elected badly enough to sign a repeal bill. These possibilities seem pretty far-fetched to DrRich, of course, but to DrRich the prospect of repeal does not spell Armageddon.

During the long and painful process that saw Obamacare become law, the health insurers clearly demonstrated just how far they were willing to go to keep that process alive. DrRich is certain they will be happy to go at least that far to block repeal.

So it came as no surprise when, just last week, the insurers sent Republicans their first, gentle reminders that they will not countenance any such thing. At the Reuter’s Health Summit in New York, David Cordani, the CEO of Cigna, warned Republicans, “I don’t think it’s in our society’s best interest to expend energy in repealing the law. Our country expended over a year of sweat equity around the formation of it.” And Mark Bertolini, president of Aetna, said that any attempt to repeal Obamacare, or even an attempt to hold up funding for it, would be “problematic.” “We can’t go back,” said Bertolini,  “We need to keep moving, and we need to improve upon what we have.”

These seemingly mild-mannered statements should send a chill up the spines of Congressional Republicans. Any repeal of Obamacare necessarily and utterly relies on the acquiescence of the insurers, on their desire (or at least willingness) to continue with their current business model (possibly with some tinkering around the edges). Republicans, bless their innocent hearts, assume that’s what the insurers want.

But the truth is that the insurers know that their current business model is completely defunct, and far beyond any salvation. They see Obamacare as their only visible lifeline, and any serious threat to Obamacare as a threat to their survival.

The health insurers simply will not countenance a repeal of Obamacare. They will do whatever is necessary to demonstrate this fact to the Republicans. Their initial foray is suitably gentle. But once the repeal effort gets revved up, watch out. The insurers have already graphically demonstrated just how ungentle they can be.

If the Republicans really want to get rid of Obamacare, they’re going to have to propose an alternate solution that, among other things, provides the health insurance industry with a new and viable business model, one that seems at least as good to them as the rather paltry one Obamacare has promised. (If the Republicans want such an alternate solution, they have only to ask DrRich.)

DrRich does not think the Republicans have any idea of what may be coming their way, and from the very industry, no less, they consider to be their chief ally in the healthcare wars.

They should pay more attention.

In his last post, DrRich suggested that the Guideline Wars (i.e. the bloody battles over who gets to establish the patient-care guidelines that determine which patients will get which medical services, and which medical specialists will get to provide them) are about to enter the Obamacare phase, in which those who make the guidelines will no longer be medical professional organizations, but agents of the federal government. DrRich helpfully labeled the various guideline panels provided for by the Obamacare legislation as the “GOD panels” (for Government Operatives Deliberating), in order to avoid using the more inflammatory “death panels” terminology favored by certain less sophisticated commentators.

In addition, DrRich pointed out that his own tribe of medical specialists – the cardiologists – may perhaps be in a better position than most other physician tribes to manipulate the deliberations of these GOD panelists. The cardiologists would attempt such manipulations, DrRich suggested, by “pre-spinning” certain critical data from clinical trials, before that data is taken up by the government panels.

From their long experience in fighting the Guideline Wars, cardiologists understand that data from clinical science does not invariably lead to a fixed conclusion (as most proponents of evidence-based medicine seem to believe), but rather, can often be shaped into whatever sort of conclusion one might want to reach. Just as different primitive cultures discerned different constellations when they looked up into the same night sky, so will different groups of experts come to different conclusions when they look at the same clinical data.

Accordingly (DrRich submits), cardiologists have already embarked on the task of pre-spinning the data, such that when the GOD panelists look for the first time up into the vast and chaotic sky of clinical evidence, they will have in hand a map of the constellations as seen by the cardiologists.

To illustrate what he means, DrRich calls his readers’ attention to the SYNTAX trial, a clinical trial designed by cardiologists and their industry partners for the purpose of reaching a specific conclusion, but which (unfortunately for cardiologists) reached the opposite conclusion. If the data from the SYNTAX trial should ever fall into the hands of the GOD panelists (or any other guideline panels) in a pristine fashion, it could spell disaster. So the cardiologists have spent nearly two years attempting to make the data say what they want it to say, and today, after continuously massaging the data, issuing press release after press release, making presentation after presentation, and publishing academic paper after academic paper, it would be at least a little surprising if the God panelists, surveying this body of pre-spun data, would fail to produce clinical guidelines which provide the cardiologists at least some of what they’re after.

The SYNTAX trial randomized 1800 patients with complex coronary artery disease (i.e., CAD that produces either significant blockage in the left main coronary artery, or severe triple-vessel disease) to therapy with either bypass surgery or drug-eluting stents (DES), and assessed their long-term outcomes.

In general, patients with stable CAD (i.e., those who are not currently having a heart attack or unstable angina) do just as well with aggressive medical therapy as they do with invasive therapy. People like the ones enrolled in SYNTAX, however, are the exception to this rule. That is, patients with either of these two specific patterns of complex CAD have been shown to have improved survival if they receive bypass surgery. Indeed, these patients represent a virtual “last stand” for cardiac surgeons – they are nearly the only patients cardiologists (at least some cardiologists) still feel obligated to refer for bypass surgery. And, as one might expect, in their decades-long turf war with cardiac surgeons (a war from which they will not desist until they see the great majority of cardiac surgeons seeking jobs as beer vendors at sporting events), cardiologists have long chafed at this singular remaining obligation to refer.

Accordingly, SYNTAX, a study instigated by cardiologists and sponsored by Boston Scientific (a manufacturer of DES), was intended to show that with modern cardiac stents, stenting yields outcomes that are not significantly inferior to bypass surgery in these patients. Specifically, that is, SYNTAX was designed as a “non-inferiority trial.” This was certainly a modest goal – some might say too modest – but a positive result would enable cardiologists (the gatekeepers to all invasive CAD therapy) to simply keep these patients for themselves, just as they now do with all the other CAD patients. The SYNTAX trial asked the question, “Do I really have to refer these patients to the cardiac surgeon?” And the desired answer was, “No, it apparently is not statistically provable that you absolutely have to refer them, one supposes.” Judging from the study design, that answer would have been plenty rigorous enough for the study designers.

Alas, however, when the one-year follow-up data for the SYNTAX study was analyzed, the results turned out to be negative; stenting was significantly inferior to surgery. The endpoint of the study was a composite called MACCE (Major Adverse Cardiac and Cerebrovascular Events), and in this study included death, heart attack, stroke, and the need for more revascularization procedures. The bottom line is that in SYNTAX, the risk of MACCE was significantly higher for stenting than for bypass surgery. The study failed to meet even the modest non-inferiority goal the cardiologists had devised for it.

The one-year data for the SYNTAX trial was published in the spring of 2009 in the New England Journal of Medicine, just as the battle over healthcare reform was taking shape, and nearly six months after Sarah Palin had reported her mysterious vision of death panels. But whether one wanted to call them death panels, GOD panels, or panels of distinguished monkeys, it was clear by the time SYNTAX was published that the government, and no longer the physicians’ own specialist organizations, would be manufacturing all clinical guidelines in the near future. So disaster loomed.

But, the cardiology community quickly rallied, and launched into a concerted effort to spin the results of SYNTAX from a disaster into a victory, or at least, to something akin to victory. And the efforts of the cardiologists in this regard have been impressive over the last 18 months.

Within minutes of the publication of the original SYNTAX article, scores of press releases were launched, and scores of “experts” were dispatched to give interviews, implying that the SYNTAX study was a major, ground-breaking victory for stenting.

For instance, here’s the link to an article in the New York Times (subsequently reproduced in hundreds of newspapers around the country) entitled, “Heart Stents Found As Effective As Bypass For Many Patients.”

And here’s a triumphant press release from Boston Scientific, the study’s sponsor, in which the negative overall results of SYNTAX are buried deep within the 6th paragraph (following all kinds of positive-sounding fluff), and are difficult to locate even if you are specifically looking for them.

And here’s the more-than-triumphant press release from one of the leading clinical sites for the SYNTAX trial, which reads, in part:

“At NorthShore, we experienced stunning outcomes [emphasis DrRich's] in patients whose only option would have previously been bypass surgery,” said Ted Feldman, M.D, F.S.C.A.I., Director of Cardiac Catheterization Laboratory, NorthShore University HealthSystem, and a lead investigator of the trial. “The data in this study will provide cardiologists with additional information as they determine treatment therapy for patients with complex CAD.”

Most remarkable of all, we have the spectacle of the lead author of the SYNTAX paper, Dr Patrick W Serruys himself, telling Heartwire immediately after publication of the paper, that the paper’s concluding sentence (i.e., “CABG as compared with PCI is associated with a lower rate of MACCE at one year among patients with three-vessel or left main coronary artery disease (or both) and should therefore remain the standard of care for such patients.”), is just plain wrong. Serruys declared that this concluding sentence actually “is not the essence of the trial.” He only allowed that concluding sentence to appear in the paper, he said, “because the New England Journal of Medicine wanted something more conservative.” (Apparently, having the paper appear in a prestigious journal overrode the necessity of having the paper accurately reflect what the authors meant to say.)

In any case, Serruys insisted (despite the conclusion expressed in his ink-not-yet-dry paper) that many patients like the ones enrolled in the SYNTAX trial can safely be treated with stents, and indeed, he announced that he and his co-investigators were hard at work teasing apart the SYNTAX data in order to develop a so-called “SYNTAX score,” that would help cardiologists determine which patients they can treat themselves, without referring them for surgery. So indeed, despite the negative results, and despite the conclusion written in their own paper, the SYNTAX trial was immediately spun by key trial participants themselves into a win (while not a complete victory, still a win).

Before his readers come down too hard on the cardiologists for such behavior, DrRich feels obligated to point out a partially mitigating truth. Namely, cardiologists believe to the depths of their souls, notwithstanding the largely negative body of medical literature to the contrary, that stenting coronary artery blockages – in virtually any configuration and any clinical situation – saves lives. And if they haven’t been able to prove that yet, it’s just because of the vagaries of clinical research. One must not let spurious results from imperfect research block the Truth, lest one allow great harm to come to humanity.

The results of the SYNTAX trial must simply be wrong, cardiologists believe, and so they would be gravely harming patients if they did not take whatever steps were necessary to render the results of SYNTAX more favorable to stenting. To do otherwise would cause thousands of clinicians to make inappropriate decisions.

In this way, DrRich believes, cardiologists are no more guilty than are Progressives, another category of humans who believe with their hearts and souls in something that is simply not true (in the case of Progressives, that the great mass of humanity will willingly suppress their own individual interests in favor of the interests of the collective). Like the Progressives, cardiologists are often very nice, well-meaning, sensitive and compassionate individuals, and some of them would even be fun to go out with for a beer.

In other words, DrRich pleads, cardiologists are not being particularly evil in spinning the SYNTAX trial results; they are simply doing what comes naturally, and what they deeply believe to be the right thing.

This is why the SYNTAX investigators were convinced that, buried within the vast body of clinical data the SYNTAX trial has generated, there simply MUST be something useful to cardiologists. Accordingly, the SYNTAX investigators dived head-first into the proverbial room full of manure, enthusiastically digging for the pony which simply must be in there somewhere.

And indeed they quickly found their pony.

And here it is: While a straightforward analysis of the SYNTAX study shows that bypass surgery wins hands down over stenting, if one delves a bit deeper into the data, one finds that one of the components of the MACCE endpoint – the incidence of stroke – was statistically higher among the patients randomized to bypass surgery. One also finds that the incidence of needing revascularization during follow-up was higher in the stent patients. So, taking these two interesting observations together, the cardiologsts have concluded that patients receiving bypass surgery are trading a reduced need for subsequent revascularization for an increased risk of stroke – a bad trade indeed. Therefore, despite the overall results of the study, they have concluded that stents are better than bypass surgery for at least some patients. (And they promised to discover for us, during the data-mining exercise from which their “SYNTAX score” was subsequently invented, which patients those are.)

And this – the reduced incidence of stroke seen in the stent patients – is the basis for the celebratory statements which were issued by the SYNTAX investigators upon publication of their original paper.

DrRich agrees that, as a general proposition, he would probably rather have an extra invasive cardiac procedure than a stroke, and suspects that most people would say the same thing. But before we all buy what cardiologists are selling here, DrRich would like to make a few observations.

First, the results of the SYNTAX trial are the results. Stenting did not meet even its modest non-inferiority endpoint, and it failed to meet it by quite a lot. Once the pre-designated endpoint of a randomized clinical trial is determined, any remaining observations that can be gleaned from the large amounts of data invariably generated by such trials must be viewed as inconclusive, as merely hypothesis-generating. Such observations are not to be regarded as having sufficient statistical surety to vastly change medical practice, or to figure into evidence-based guidelines. So, another clinical study would need to be conducted to prove the hypothesis that strokes are less frequent with stenting than with bypass surgery in patients like these.

Similarly, the “SYNTAX score” – which indeed was generated and subsequently published as a “guide” for cardiologists treating patients with complex CAD, and which is therefore presumably being used today by cardiologists all over the world to select which of these complex patients they can just go ahead and stent rather than refer for bypass surgery – has no business being incorporated into clinical practice. An exercise like this – in which investigators comb retrospectively through the clinical data, selecting out patients who had good results with stenting, then devising a group of characteristics that appears to differentiate them from those who did not – cannot possibly yield a validated, widely-applicable clinical tool. If they want to claim that their SYNTAX score is clinically useful, they need to conduct another randomized clinical trial to test that hypothesis.

Next, and most remarkably, there’s the almost universally-ignored fact (reported by Dr Friedrich W Mohr, co-principle investigator of the trial), that among patients assigned to bypass surgery in the SYNTAX trial who experienced a stroke, nearly half of them had their strokes PRIOR TO SURGERY. What this means is that, in reality, the bypass surgery itself did not cause those strokes, a fact that ought to cause serious damage to the chief assertion of the stent-proponents. This fact alone turns their pony into a pig. The claim that stenting instead of surgery would have avoided these strokes is largely, if not entirely, spurious. Indeed, if anything, the fact that patients “randomized” to surgery apparently had a lot of strokes in the brief period of time between the act of randomization and the surgery itself ought to make one question whether the selection of therapy was really and truly random, or whether, somehow, patients who looked particularly sick got sent preferentially to the surgeons.

And finally, the clinical choice as it has been starkly painted by many proponents of stenting – that the real trade-off in choosing between stenting and bypass surgery in these patients is the choice between the higher risk of stroke with surgery versus the higher risk of revascularization with stenting – is incomplete and misleading. Presenting the choice in this way clearly favors stenting, and this presentation entirely explains the positive press releases and subsequent media coverage of the SYNTAX trial. But this is not a valid comparison of risks for several reasons:

1) As noted above, the actual risk of stroke posed by performing bypass surgery in the SYNTAX trial has been substantially overstated for public consumption (by implying that the surgery caused those strokes, when half occurred prior to surgery).

2) Surgeons in the SYNTAX trial most often did not employ newer techniques now in routine use, such as off-pump surgery and LIMA grafts, both of which can substantially reduce the risk of stroke and other embolic phenomena.

3) Re-occlusion of the involved arteries (which occurred about equally in both groups in this study, and which spokespersons for SYNTAX seem to brush off as not such a big deal), is an entirely different phenomenon in patients who have received DES than it is in patients who have had bypass surgery. After bypass surgery, re-occlusion tends to occur gradually, and the patient generally experiences recurrent symptoms of angina. But in DES, re-occlusion much more commonly occurs acutely, and catastrophically, leading rapidly to permanent cardiac damage and often, to sudden death.

4) Item # 3 might explain why the composite endpoint of “death, heart attack and stroke” was equal in both groups, even though stroke was significantly higher in the surgery group. That is, in order for the math to work out, the remaining dyad of “death and heart attack” necessarily must have been higher in the stent group. As far as DrRich can tell, this point has never been discussed in public.

5) In order to avoid the catastrophic re-occlusions seen with DES, cardiologists now insist that their DES patients take long-term, even life-long, Plavix, a powerful blood thinner. As the purveyor of a patient-oriented website on heart disease, DrRich cannot tell you how many distressed and stented-up patients have written to him with the following lament:

“My doctor put in one of those drug coated stents and has me on Plavix. He says if I stop the Plavix I could die, and won’t let me stop it for any reason. But I need my gallbladder out because I keep having gallbladder attacks, and the last one gave me blood poisoning. My surgeon says I need the surgery but he won’t do it unless I stop Plavix, and my cardiologist says no stopping the Plavix for any reason. What can I do? Can they just take these stents out so I can stop the Plavix?”

There is no easy answer to this question, at least not that DrRich can find. The DES patient commonly is left in the middle of a pissing match between surgeon and cardiologist. The fear of the cardiologist is that when one stops Plavix, there is a risk of sudden, catastrophic thrombosis of the coronary artery. But surgeons simply cannot operate safely on patients taking this drug. Few cardiologists seem to explain this to their patients before placing DES.

And more to the point at hand, none of the cardiologists spinning the SYNTAX trial are explaining to the public the implications of long-term Plavix. Even if their claims that stenting yields significantly fewer strokes turned out to be accurate, the choice here is clearly NOT a simple one between a higher risk of stroke on one hand, and a higher risk of needing “revascularization” (if they survive the re-occlusion, that is) on the other. There’s a lot more to think about than that, and cardiologists who imply otherwise are being either disingenuous, or delusional.

Just last week, SYNTAX investigators reported on the three-year outcomes in patients enrolled in the trial. The results, similar to the one-year outcomes, remain strongly in favor of bypass surgery at three years, and indeed, the incidence of stroke in stented patients has “caught up” with the incidence of stroke in the surgery patients.

This persistently bad news still does not really phase the cardiologists, who are now saying that the results of SYNTAX don’t really apply any more in any case, because drug-eluting stents have been improved since the trial was done.

It would appear that the cardiologists are going for some sort of official announcement to the effect that that the results of SYNTAX are, for practical purposes, indeterminate, and that what is needed is a new clinical trial, in which patients randomized to DES will receive the latest generation of stents. (Since there is a new generation of stents every year or so, this entire process can be repeated as needed until the cardiologists finally get the results they’re looking for, at which point they can declare final victory and stop.)

Summary:

All medical specialists should take a lesson from the cardiologists. In an era in which specialist organizations will no longer be writing the clinical guidelines for their own specialty, it is necessary to aggressively pre-spin any important clinical data upon which the GOD panels will be deliberating.

Considering the SYNTAX trial as a case study, one sees how it is possible to take the most straightforward results from a very straightforward clinical trial and, if not turn a negative outcome into a positive one, at least introduce enough complications, nuance, spin and uncertainty to cause any self-respecting GOD panelist to hesitate in making a definitive pronouncement on those results. Then, if you couple all the uncertainty you’ve created with a loud call for yet another clinical trial – one that will take into account new equipment, new techniques, new scoring systems &c., and that promises to clear up all the confusion you’ve dug up as a result of the last clinical trial – then you stand a decent chance of at least getting a postponement on any new guidelines harmful to your cause.

And this, you neurologists, gastroenterologists, pulmonologists and all you other, less savvy medical specialists, is how one can manage the GOD panels.

In quainter times, medical “guidelines” merely meant a set of general principles which doctors ought to keep in mind when deciding on the most appropriate medical care for their patients. But in recent years guidelines have come to represent reasonably firm expectations for medical practitioners. And doctors who fail to closely follow guidelines may not be looked upon favorably any more by insurance companies or Medicare.

Obviously, then, since the guidelines finally determine who gets what, when and how, controlling the guidelines (i.e., making sure the guidelines say what you want them to say) has become important to any interest group within the healthcare system. And nobody understands the critical importance of guidelines better than cardiologists, a group of which DrRich is a proud member.

In a valiant attempt to carve out as much turf for themselves as possible within a healthcare system driven by guidelines, cardiologists, through their powerful professional societies, have been vigorously fighting the Guideline Wars for two decades – well before most other medical specialties even recognized that a war was being fought. This long struggle has lent to the cardiology profession a certain level of experience and sophistication that may help them to preserve some of their hard-won turf, even as we move into a far more dangerous phase of the Guideline Wars, in which less robust specialties risk debilitation, and even extinction.

For, under Obamacare, guidelines are now to become far more than mere guideposts, or principles, or even strong expectations. They are to become handed-down and inviolable rules which will dictate the details of proper patient care, and which doctors must follow to the letter. Following this new species of guidelines as closely as scripture will be necessary for any doctor who wants to be officially tabulated as a “physician of quality,” who desires to be paid the going rates, and who would prefer to avoid fines or imprisonment for fraud (fraud being, of course, the failure to practice medicine according to the guidelines).

Whereas until now the Guideline Wars have been largely fought among various medical specialties competing for turf, from now on the major combatant in these wars will be the federal government. Under Obamacare, the official medical guidelines will no longer be determined by conflicted medical specialty organizations (which will always try to establish guidelines that cause the healthcare system to spend lots of money on their specialists), but instead by government panels, which will have their own obvious conflicts of interest.

Most observers of the healthcare system seem congenitally unable to recognize that a government bent on controlling the behavior of its citizens (in order to create the perfect healthcare system, which, in turn, is a necessary component of a perfect society) will be working under, if anything, more conflicts of interest than any other healthcare entity.  In particular, the government, and by extension its appointed panels, will be desperate to the point of apoplexy to avoid spending any money, at any time, for any medical services, any time they can get away with it. So ultimately, the widespread proposition that the government panels will be entirely free of any particular agendas, or conflicts, or prejudices, as they hand down the rules of medical engagement to physicians, is balderdash.

The abiding conceit of the government panelists, of course, is that they will behave in an entirely objective manner in rendering the guidelines of medical practice, and will simply follow the science wherever it may lead, without any prejudice whatsoever. That is, they will not actually create the guidelines, but will simply “discover” them, through the objective application of clinical science. In other words, under Obamacare, the “true” medical guidelines will be handed down not by flawed men saddled with conflicts of interest, but by the inherent properties of nature. The government panels will simply be interpreting nature, and will do so, unlike those conflicted physicians, without prejudice.

Indeed, DrRich will go so far at to point out that the Obamacare guidelines will come from GOD – Government Operatives Deliberating. Readers who think it is in poor taste to refer to these individuals – who will invent the guidelines which will determine life and death for so many of us – as GOD panelists should be reminded that other, less sensitive individuals have tried to label them “death panelists.” DrRich’s nomenclature is not only more descriptive, but is much kinder.

In any case, this is where cardiologists have a tactical advantage over most medical specialists as we enter the Obamacare phase of the Guideline Wars. For, in their decades-long struggle in those wars, cardiologists have discovered something that more naive and inexperienced medical specialists, as well as academics, and even most government advisers, are only dimly aware of. Namely, that there is no such thing as the objective application of clinical science. Inevitably, interpreting clinical science – which is among the most inexact of the sciences – incorporates inherent bias.

That bias can be applied either subconsciously or consciously, but one way or another it is applied. And the advantage the cardiologists have over other medical specialists is that they understand that, to have a better chance of getting what they want, they need to direct the application of bias in interpreting critical clinical trials, and they must do it aggressively.

At the highest levels, of course, the agents of the government understand the very same thing. This is why they are setting up their own panels to control the guidelines in the first place. And you can be sure they will choose their panelists carefully.

But DrRich (and his cardiologist friends) know that when the government panelists are being sworn in, they will not be told their true mission in stark terms. They will not be told, “Your job is to twist the eminently-twistable clinical data in any way you must in order to reduce spending on healthcare, no matter who is hurt by it.” This charge would be unacceptable to most of the individuals the government would prefer to choose as panelists, namely, proud and accomplished individuals with valued professional reputations to uphold (though, to be sure, with a proven track record of thinking about clinical science with the kind of bias the government appreciates).

Rather, the panelists will be told:

“Panelists! You have perhaps the most critically important job in all of healthcare, namely, reining in the counterproductive, harmful, wasteful activities of the self-serving medical profession, which is married to greed, and beholden to its evil partners in medical industry. Your job is to lead doctors (most of whom would do the right thing if they can be shown the way in a sufficiently forceful manner) out of the wilderness, and bring them to the path of righteousness. For we hold these truths to be self-evident: that good medical care is efficient medical care; indeed, it is parsimonious medical care; and this being the case, the proper interpretation of clinical science will virtually always show us that less is more. It is your job to interpret clinical science in that proper way, to show American physicians how to fulfill their primary moral obligation to the greater health of the collective.”

DrRich has already demonstrated that there are plenty of physician-ethicists in very high positions who completely buy this stuff. It will be no problem for the Feds to find as many of them as they want to populate the GOD panels, and indeed candidates are virtually tripping over each other to audition.

In any case, their government handlers will reassure all the panelists that they simply are to follow the science, while establishing very strong expectations as to where properly-applied science will inevitably lead. This procedure will be aimed at allowing panelists to maintain the soothing and necessary fiction that they are, in fact, functioning as unbiased agents of reason and logic, and are well-deserving of public adoration, and perhaps even of self-respect.

Cardiologists, battle-hardened Guideline Warriors that they are, understand the position in which the new GOD panelists will find themselves, and as a result they understand that the clinical science these panelists will use to fashion medical guidelines must not reach them in anything like a pristine condition. Rather, that clinical science must reach them “pre-spun,” with the “right” interpretations already spelled out for them by respected academic figures, and, to the fullest extent possible, already permeated into the public consciousness. Cardiologists hope that panelists will be relatively reluctant to make guidelines which are starkly opposed to such predisposed interpretations, for fear they will be found grating to professionals outside of government whose opinions they might value.

With such a strategy the cardiologists are perhaps clinging to a thin thread. It is, in fact, not much of a plan. But it beats whatever it is you gastroenterologists are doing.

In his next post DrRich will illustrate cardiologists’ new strategy of “pre-spinning” clinical trial data, in order to make it more difficult for GOD panelists to do them grave harm.

In a remarkable article that somehow* was accepted for publication in the Annals of Internal Medicine, the White House offered some friendly advice to American PCPs who may be wondering how Obamacare will affect them. That advice, to summarize, is: “We are the Borg. Prepare to be assimilated.”
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* DrRich is forced to wonder whether yet another group of medical editors is auditioning for the death panels.
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The article was written by Ezekiel Emanuel from the White House’s Office of Management and Budget, and Nancy-Ann M. De Parle, who is Mr. Obama’s Czar of Healthcare Reform. (A third author was from the McKinsey Group.) After reminding physicians of their moral obligation to the collective, the White House authors rhapsodized about all of the wonderful changes inherent in Obamacare that will help physicians to realize this obligation.

There’s actually no need to read the entire article, assuming you heard any of the 400 speeches President Obama delivered in his unsuccessful attempt to convince the public that his healthcare reforms ought to displace the holy writ as The Good News. The meat of the article, if you’re a physician, appears at the end:

These reforms will unleash forces that favor integration across the continuum of care. Some organizing function will need to be developed to track quality measures, account for and manage shared financial incentives, and oversee care coordination….These coordinating functions, to the extent that they currently exist, traditionally have been managed by hospitals or health plans….As physicians organize themselves into increasing larger groups — patient-centered medical home practices and accountable care organizations — they are, out of necessity, investing in information technology tools that are becoming both cheaper and more capable and investing in the acquisition or development of management skills that could provide these organizing functions efficiently for physicians groups….For physicians, this means a profession that is more rewarding, more productive, and better able to realize its moral ideal.

DrRich translates this message thusly: “Physicians! You have been neglecting your moral obligation to the collective, in favor of your archaic devotion to the individual patient. Under Obamacare you will need to join organizations which are devoted to the collective goals of Obamacare, and which therefore will guarantee the proper moral ideals. You must function not as individual decisionmakers, but as integrated cogs in a vast healthcare continuum, which will stretch from the centralized bastion of gleaming moral authority (from which we pen this message) all the way down to the humble tip of your stethoscope. You will be rewarded for your cooperation, or suffer for your resistance (resistance, of course, being futile).  So rejoice for the health of the collective, and for your own well-being, and prepare to be assimilated.”

Ostensibly this message is for all American physicians, but it was submitted to the Annals of Internal Medicine for a reason. The Annals is the journal of record for doctors who practice internal medicine, and who comprise the largest group of PCPs. The White House in this article is speaking directly to American PCPs.

This is because PCPs pose the greatest short-term threat to Obamacare.

Most medical specialists have already been “assimilated.” Because they require lots of expensive stuff to practice their specialties – things like gamma cameras, operating suites, catheterization laboratories, hordes of highly trained medical technicians, &c. – it is very difficult for most specialists to function as independent operators. If you want medical specialists to follow the rules, all you have to do is make following the rules a requirement for keeping their access to all the technology and the complex infrastructure they need to practice their specialties.

Only PCPs can fairly readily make themselves independent from the collective.  And more and more PCPs are choosing to do so.

The White House does not like this.  The Annals article, DrRich thinks, is the administration’s first official attempt to curtail the PCPs’ fledgling independence movement. The threat is veiled – the article instead appeals to the PCPs purported moral obligation to the collective, and emphasizes the rewards that will follow when PCPs allow themselves to be assimilated into the Borg.

So this first attempt, for the most part, is merely creepy. The next step will not be as benign.

DrRich urges his PCP friends to take heed. If you have any thought of striking out on your own, and starting a direct pay practice – thus reasserting your profession’s real moral obligation, which is to your patients – you had better act now, before it becomes a federal crime to do so.

DrRich’s last post addressed a recent issue of the Archives of Internal Medicine which, strikingly, was largely dedicated to trashing the JUPITER study.

The JUPITER study was a landmark clinical trial in which giving the statin drug Crestor to apparently healthy individuals who were at increased risk of cardiovascular disease (and most particularly, had high CRP levels) resulted in a significant improvement in outcomes. In particular, within two years, individuals taking the statin had a 20% reduction in overall mortality, a 54% reduction in heart attacks, a 48% reduction in stroke, and a 40% reduction in venous thrombosis and pulmonary embolism. All these findings were highly statistically significant.

DrRich attempted to show that the criticisms of JUPITER recently offered by the Archives were sufficiently spurious to raise the question of what the authors and the editors were really trying to accomplish, and for him to suggest that perhaps they were auditioning for appointments to the government’s expert medical panels, which will soon begin determining who gets what, when and how. Indeed, DrRich will actually be quite surprised if none of these individuals end up with such an appointment. They have clearly demonstrated they have the right stuff.

Still, as DrRich also pointed out, the JUPITER study, while a reasonably straightforward clinical trial whose results seem impressive, was anything but air-tight. No clinical trial is air-tight, however, and if medicine were still practiced the way it should be, the JUPITER trial could be smoothly incorporated – with all its limitations – into clinical practice without a hitch.

But, since medicine is now practiced by guidelines, JUPITER poses a major problem. In fact, it has led to major and contentious debates between those who insist its results must be incorporated into formal clinical guidelines, and who insist they should not. On one hand, many point out that JUPITER is an important clinical trial which has demonstrated a vital clinical benefit (prevention of heart attack, stroke and death) with a high degree of statistical significance, which meets the high standards demanded by evidence-based medicine, and which therefore obviously demands a change in the clinical guidelines. But on the other hand, many others insist that the JUPITER trial simply does not demonstrate enough of a benefit with Crestor to justify changing the guidelines.

DrRich’s position – that the results of the JUPITER trial are striking and important but incomplete, and ought to change the conversation between, but not dictate the actions of, doctors and patients – simply does not obtain in the modern era.

So, unable to side with either party, DrRich observes with great interest the debate between those who want to change the guidelines, and those who believe that changing the guidelines would be the greatest of travesties.

Those who want to change the guidelines have, in their favor, the virtue of consistency. For, if one insists that every action by physicians must be supported by evidence-based medicine, then one is pretty much obligated to fully embrace legitimate clinical trials like this one that give clear-cut and statistically significant results. Unfortunately, the evidence-based strict-constructionists have painted themselves into a corner when it comes to JUPITER. They will not be able to say, for instance, “Statins are pretty much alike, so we’ll make the guidelines say ‘statins’ instead of ‘Crestor.’” For JUPITER did not study “statins,” it studied only Crestor, the most expensive statin on the planet. Expanding the results to all statins (despite a large body of experience that suggests this would be just fine) does violence to the whole concept of evidence-based medicine. It’s just not possible. The strict constructionists have therefore boxed themselves in to advocating a new, multi-billion dollar annual expenditure.

It is even more amusing to observe those who do not want to change the guidelines.

These people fall into two general camps. First, and easier to dismiss, are those who believe that drug companies are the embodiment of evil, and that any clinical trial sponsored by a drug company must be dismissed out of hand, particularly if the drugs which are being promoted are statins. (This, in fact, is the level of argument on which the main article in the recent issue of Archives relies.)

DrRich simply notes, once again, that the advancement of clinically useful medical science – in America and in the world – is almost entirely dependent on drug companies and other corporate dens of iniquity. That companies must pay for our medical research is the system we’ve invented. Furthermore, our total capitulation to the dictates of evidence-based medicine means that companies must fund large, expensive clinical trials like JUPITER before they are allowed to sell a new product, or to create a new indication for an old product. This evidence-based paradigm is inherently a double-edged sword. Sure, it creates a huge barrier to the development and adoption of expensive new therapies (which is the covert rationing dividend of evidence-based medicine), but it also creates opportunities, for companies who manage to successfully complete such trials, to create iron-clad indications for their products. For, once a product has been “proven” in a randomized clinical trial, there is no easy way to legitimately keep that product out of the guidelines and off the shelves. The makers of Crestor have simply figured out the rules. One can whip up anti-corporate emotions by criticizing the sponsor for playing the game well, but the fact that the sponsor stands to gain does not negate in any way the results of a well-designed study.

That the anti-pharmaceutical and anti-statin crowds vociferously object to the results of the JUPITER trial is, of course, entirely expected and cheerfully acknowledged. DrRich will merely observe that their position is one of default. It is not dependent on the scientific merit of JUPITER (or any company-sponsored study), and thus it adds no useful information to the debate. We can only note their objections and move on.

The second group of people who object to changing the guidelines are less dogmatic and more open to reason, and indeed (and very interestingly so) claim to be proponents of evidence-based medicine, and thus claim to be willing to follow the data to where it will lead. It seems pretty clear (to DrRich, anyway), that the chief concern of these individuals, as it relates to JUPITER, is cost. That is, this group feels strongly that the implications of the JUPITER trial are simply too costly to follow to their logical conclusion. This, indeed, is a very reasonable position to take.

Unfortunately, the only legitimate way to turn aside the results of a costly but statistically definitive, evidence-based study is by rationing healthcare. (To ration, remember, is to withhold at least some useful medical services from at least some people who would be likely to benefit from those services.) But we can’t do that, because, well, it would be rationing. Because members of this second group are unable to invoke the “r” word, they are therefore forced to find other “reasons” for keeping the guidelines unchanged. This unfortunate situation leaves them little choice but to discover ways in which to impugn the legitimacy of the JUPITER trial.

In short, they find themselves forced to engage in statistical legerdemain in order to diminish the significance of the JUPITER trial. There are several useful statistical arguments they can employ.

From what DrRich has seen, many of the arguments that have been ginned up to this end have not come directly from the JUPITER trial itself, but instead from an editorial accompanying this study, written by Dr. Mark A. Hlatky.

Most of Dr. Hlatky’s editorial is measured and reasonable. But he threw in a key summary sentence that has been greedily grasped by the anti-alter-guidelinetarians, to wit: “The proportion of participants with hard cardiac events in JUPITER was reduced from 1.8% (157 of 8901 subjects) in the placebo group to 0.9% (83 of the 8901 subjects) in the rosuvastatin [Crestor] group; thus, 120 participants were treated for 1.9 years to prevent one event.”

This statement, at least taken at its face value as a stand-alone analysis, is statistically naive and wrong. DrRich realizes that one or two of his readers might not enjoy statistical arguments, so if you do not wish to wade through the reasons why, simply skip the next two indented paragraphs.

In a long-term clinical study in which the endpoints are events that can occur at any time (such as heart attack, stroke or death), then the probability that an enrolled patient will reach an endpoint in the trial increases the longer he/she has been enrolled in the trial. But in virtually all clinical trials, the length of time different people are enrolled varies greatly. This is because it often takes years to enroll people in clinical trials, so that when the trial ends, some will have been in the trial for many years, others for only a little while. This means that the risk exposure of each research subject is different, and is proportional to the total time they were enrolled. Not uncommonly, the enrollment process is not smooth – there are periods of more rapid enrollment, and periods of slower enrollment – so if all you do is average the enrollment time (as was done by Hlatky – 1.9 years) you are likely to get skewed results. So it is simply not statistically legitimate to do so.

There is a legitimate way of analyzing such longitudinal outcome statistics, and it’s called the Kaplan-Meier method. And indeed, the authors of the JUPITER trial presented in their paper a complete Kaplan-Meier analysis of their data (see Figure 1 of their paper), and the results look quite a bit different from Hlatky’s summary statement. The Kaplan-Meier analysis reveals that the risk of heart attack, stroke, and death all increase steadily through at least 4 years (5 years was the longest time anyone was enrolled in this study), so that at 4 years, the risk of reaching one of the “cardiovascular event” endpoints was about 8% (not 1.8%). Further, the Kaplan-Meier analysis shows that the protection imparted by Crestor persists through at least 4 years, and that indeed the magnitude of protection (i.e., the difference in outcomes between the treated group and the placebo group) increases throughout that entire duration. So, at 4 years, the placebo group had roughly an 8% event rate, compared to roughly a 3% event rate for the Crestor group – an absolute difference of about 5% (not 0.9%). This is a far greater benefit than is suggested by Hlatky’s shorthand summary.

Suffice to say, then, that Hlatky’s summary statement apparently ignores the appropriately analyzed data which is clearly presented in the JUPITER paper itself, and which documents that the clinical benefit of Crestor was substantially more impressive than his widely-quoted summary statement suggests.

But as illegitimate as this summary statement may be, let us accept it at face value for a moment just for the sake of discussion, since that’s the data the anti-alter-guidelinetarians have latched on to.

Taking these numbers, the “antis” make the following argument: While the relative reduction in “hard cardiac events” is 50% (1.8 to 0.9), the absolute reduction is only 0.9%, which, anyone would agree, is a pretty small number. So, they conclude, the actual benefit imparted by Crestor is actually quite small.

That’s a very interesting argument. Let’s look at it in a couple of ways.

So we’ve got a population of patients whose risk of heart attack, stroke, bypass surgery/stenting, or death is about 2% at about 2 years, and by giving them a pill we can reduce that risk to about 1%, and we’re arguing that the absolute drop of 1% is not very much to crow about. Well, OK. But what if we found a pill that reduced their risk to zero at 2 years? That is, it completely wiped out the risk of cardiovascular catastrophes altogether. Would that be a good thing? Or would we say, “It’s just a 2% drop, really not much greater than the 1% drop we had with Crestor, so it’s no big deal?” DrRich thinks not. DrRich supposes we would think that totally eliminating all cardiovascular risk would be a very big deal.

When you’re starting at a 2% risk, then any drop in risk is going to be an “absolutely” small number. And if we’re not going to pursue improvements in outcome of such a small magnitude, then why the heck are we worrying about preventative medicine in the first place? Once you get past the big things (drain the swamps, don’t drink the water downhill from the outhouse, etc.) then all preventative medicine tends to consist of small, incremental improvements in outcome. Popular pronouncements to the contrary notwithstanding, preventative medicine is largely the art of spending a lot of money for this kind of incremental improvement. If we decide we shouldn’t do this anymore, then DrRich would find it unfortunate but understandable. But it hardly seems reasonable to arbitrarily focus on this one, particular improvement in preventative cardiology, and (within a healthcare system that insists it is not rationing care) pronounce that this is the one we’re not paying for.

Another way of looking at this “the benefit is too small” argument is by considering that 7.4 million Americans fit the entrance criteria for JUPITER. By giving all these people a statin, we would be preventing about 66,600 major cardiovascular events over a 2 year period. If you’re going to say that 1% is a small number, DrRich will counter that 66,600 is a big number. So do statins offer a substantial benefit or not? It depends on whether you choose to focus arbitrarily on the 1% or the 66,600.

(DrRich understands that many of his readers are not focusing at this moment on the 66,600 cardiovascular catastrophes that could be prevented, but on the 7.4 million people who will be taking a drug that costs $120 per month. But we’re not talking about cost yet, we’re only talking about whether the drug does some good. If we decide it does, then we’ll need to link that “good” to a procedure that measures whether the “good” is worth the money we would need to spend to achieve it. The “antis” try to avoid talking about cost – since that would admit they’re rationing – by insisting that there’s just not enough “good” to bother with. DrRich is simply pointing out that such an argument – that preventing 66,600 very bad outcomes is not enough to bother with – is on its face absurd.)

Another argument invoked by the anti-alter-guidelinetarians is based on the “number needed to treat” (NNT) analysis. Again they rely on Hlatky’s unfortunate summary of the data: “120 participants were treated for 1.9 years to prevent one event.” This number – which the “antis” insist is just too high – is misleading for the reasons already discussed. The real NNT, based on more legitimate statistical analysis, is plainly laid out in the JUPITER paper itself. It turns out that the longer patients in this trial were treated with Crestor, the lower the NNT became. So: At 2 years, the NNT was 95; at 4 years, it was 31; and at 5 years, it was projected to be only 25. Whether you think it is reasonable to treat 25 people with a pill for 5 years to prevent one of them from having a heart attack, stroke, or death is, DrRich supposes, a matter of opinion. But based on NNT analyses for many widely-accepted therapies in medicine today, it looks pretty good.

All these arguments, of course, are merely distractions. The fact is that JUPITER showed a pretty striking reduction in nasty cardiovascular events over s pretty brief period of time, and the only real reason there’s any controversy at all is because of the cost of Crestor.

That cost is what makes us want to withhold Crestor, even though it is imparting at least some (and, DrRich, argues, quite a bit of) clinical benefit. In other words, the high cost makes us want to ration Crestor. The fact that we can only ration covertly, instead of openly, is what makes us want to bastardize the science and do a Kabuki dance with the statistics.

If we were rationing healthcare openly, then we could do an objective, full-bore cost-benefit analysis on the use of Crestor in JUPITER patients, using legitimate and not ginned-up statistical analysis, and taking into account not only the cost of the drug, but also the cost that would be incurred by failing to stop preventable heart attacks, strokes, etc., and then determining where the overall cost-benefit result fell within our coverage criteria. If it met the criteria we would cover it, if not, not. This decision would not be arbitrary. It would be a fully transparent process, so that if the sponsor did not like the results, they would try diligently to find a way to reduce the cost of Crestor (DrRich thinks they would succeed) to a value that would be compatible with their staying in business. (And for the first time, the price of medical products would be determined by a Laffer-like curve, where a price that was too high – like taxes that are too high – would reduce revenue, instead of increase revenue. Companies, being fairly rational, would ratchet their prices down to the optimal price point.)

But since we insist on doing our rationing covertly, DrRich is sorry to say that we’re destined to keep making spurious arguments, and using dumbed-down statistical analysis to back them up. The JUPITER trial, while it is imperfect and while it does not answer every question, really is pretty straightforward. That we get so wrapped around the axle trying to fold such clinical trials into our covert rationing paradigm is simply another demonstration of the fact that covert rationing corrupts everything it touches.

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Now, read the whole story.

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

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