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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

A few years ago, one of the Ladies on the View (DrRich does not recall whether it was Rosie or Whoopie or Joy or Daisy May) “proved” that George Bush was responsible for the collapse of the World Trade Center (and not the heat generated by all that burning jet fuel), when she proclaimed that “steel does not melt.” The audience went wild with approval.

DrRich, however, was puzzled. All those years ago, when America still had lots of steel mills and DrRich used to work in one of them, he could swear that once every six hours a massive door would open on the open hearth furnace, and molten steel would flow out of it. In fact, one of DrRich’s jobs was to advance a long-handled ladle into that molten stream of new steel to acquire a sample for analysis. He would be willing to attest under oath (say, to a Federal grand jury) that the steel in his ladle was in liquid form. So, unless DrRich’s Old Fart memory fails him, steel actually does melt, as long as you can make it hot enough.

The thing about conspiracy theorists, however, is that they are never deterred by facts. And if DrRich had actually sent Whoopie (or whoever) a letter explaining her mistake, as he had thought about doing, it would not have caused her to say, “Oopsie.” She simply would have shifted to another “fact” proving that Republicans (and not Islamists) had knocked down those buildings.

The other thing about conspiracy theorists is that their methods know no party lines. Whatever their political affiliation they are usually whack-jobs. And on the opposite side of the political spectrum, the birthers – who are convinced that President Obama was not born in the USA, but instead was born in Indonesia, or Kenya, or Mars – have displayed no more reasonableness than the Ladies on the View.

So, when one thinks about it, the truly puzzling thing about the birther controversy is not that the birthers won’t give up, no matter what evidence is placed before them. That’s just what conspiracy theorists do. What’s really puzzling is why President Obama and his legal team fought them for so long before they actually produced definitive evidence of his American birth.

Astute readers might respond, “You just answered your own question, DrRich. Conspiracy theorists don’t go away just because you have the facts on your side. Even a time machine that deposited them into the birthing room in Honolulu would not have deterred them. And indeed, when Obama finally produced his birth record, the birthers immediately found six ways to show it had been Photoshopped. Giving conspiracy theorists the real facts does not end the conspiracy theory.”

Very true. (DrRich is proud to have readers like you.) The President had no hope of making the birthers go away by releasing his birth documents. But by not releasing these right away, and instead letting the matter fester for several years, he just made more problems for himself. By fighting the birthers all that time, and running up hundreds of thousands of dollars in legal bills doing it, all he accomplished was to waste a lot of money, and to raise questions among millions of more reasonable Americans who are not given to conspiracy theories.

DrRich believes he has a possible answer to why Mr. Obama stonewalled for so long on his birth records. It may be that he was signalling to his Progressive followers his baseline contempt for the Constitution.

The birthers, as misguided as they were, were raising a constitutional question. For, if Mr. Obama had been born outside the U.S., he could not legally serve as President under the Constitution*.

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*DrRich, for one, thinks this is a rather silly feature of the Constitution, which he believes Mr. Madison inserted into the document for the sole purpose of disqualifying Alexander Hamilton for the job.
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Typically, therefore, inasmuch as a constitutional question is by definition an important one, one might expect that President Obama would have produced the definitive documentation right away, to resolve the matter once and for all. And, as it turns out, he easily could have done so.

But he chose not to. He chose to let the question fester and grow, for several years, before finally putting an end to it. It’s almost as if he was saying: It’s just a constitutional question. I will actively fight against having to acknowledge the legitimacy of my presidency under the Constitution, because to do so would be to acknowledge the importance of the Constitution. And that would be beneath me, and would be at odds with my real agenda.

This message must have offered much succor to nervous Progressives, who had watched him solemnly take the Oath of Office, and had listened to his public words.

Very few Progressives – much less the President of the United States – are willing to say publicly that the Constitution is a major impediment to their program, and that one of the absolute requirements for achieving the Progressive program is to nullify the underlying thrust of the Constitution.

For indeed the Constitution is an impediment, since it firmly establishes the primacy of the individual, and severely limits the government’s ability to control the property or the behavior of individuals – both of which are critical to the Progressive program.

Mr. Obama has said so himself, publicly, before he became President. He has indicated that the chief flaw of the Constitution is that it places limits on the power of the government, and thereby prevents the government from acting to assure redistributive justice.

You can listen to him say it himself on You Tube, here.

Mr. Obama is right about the Constitution, of course. For indeed, if the Constitution granted the government the power to affect redistributive justice, it would have had to make the government all-powerful, and to make all property communal property, controlled by that government. But the founders, having just fought a war with the world’s greatest power to guarantee the autonomy of individual Americans, were disinclined to write a Constitution that immediately nullified their great victory for mankind. So the Constitution simply does not suit the Progressive agenda.

After just two years, President Obama apparently found that he had no further need to continue the charade with the birthers. He has by now, of course, amply demonstrated that the Constitution will not be an impediment to him. He has created scores of hand-picked, unelected Czars who began setting national policy and running much of the government, in independent fiefdoms, answerable only to him; he has unilaterally cancelled contractual obligations to bondholders when “negotiating” with car companies; in addition to the auto industry, he has essentially nationalized the banking industry, the insurance industry, and student loans (and thus, colleges), and of course, the healthcare industry; he went to war in Libia without even a nod to Congress; he allows his DOJ to selectively enforce or ignore laws depending on who has broken them; and he inserted an individual mandate into his healthcare reform plan, which, if upheld by the Supreme Court, will give the government unlimited authority to control the economic activity of individual Americans.

And that’s why it eventually became OK for the President to release his birth records. American Progressives, by that time, had been suitably reassured regarding his stance on the Constitution.

But thanks to the birthers, the President had a convenient way of signalling his attitude toward the Constitution, well before he had had the opportunity to demonstrate it overtly through his Presidential actions.

DrRich will only remind his conservative friends that, once a President has taken over private industry, made the Congress (the people’s branch of government) nearly irrelevant, promulgated the individual mandate, &c., the fact that the Constitution has in it some verbiage about the Presidency being limited to two-terms ought not to be given much weight.

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

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

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

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

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

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

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

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

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

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

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

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

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

The fact is, we just don’t know.

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

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

Last week, President Obama took unilateral Presidential action to fix the drug shortages that have been plaguing American hospitals since 2005.

He has been taking unilateral Presidential action quite a lot lately, in his effort to publicly emphasize the recent unwillingness of Congress to do his bidding, and to illustrate to us in the great unwashed how much better things would be if only the President could just go ahead and do all the stuff that needs to be done, without having to take the legislature into account.

For problems like this (i.e., drug shortages, lack of jobs, loss of “spirit,” &c.) are the price we pay when we insist on holding our leaders to the constraints imposed by some old, dusty, outdated document, written by someone else’s ancestors. (For how many of us, really, descend from either the Roundheads or the Cavaliers who wrote the thing?)

There are other ways one might run an enterprise, you know, that Adams or Jefferson probably never thought of.

In any case it is somewhat surprising that this time the President failed to take full advantage of the occasion. Namely, he did not blame George Bush for the drug shortages. He missed a real opportunity there, because had he done so he would have been more correct than usual.

Shortages of certain critical drugs have become a serious problem over the past six years or so. Generally speaking the drug shortages have involved sterile, injectable generic drugs. Sterile injectables are relatively expensive to make, and because the requirement for sterility dictates they must have a finite (and relatively short) shelf life, they are relatively expensive to manage logistically after they are made.

The shortages are in some of the more important and critical drugs used in medicine, including “crash cart” cardiovascular drugs, antibiotics, and important chemotherapy agents used for cancer. In recent years increasing numbers of patients with life-threatening illnesses have not been able to receive the drugs they need to optimize their odds of survival, and they have had to receive some substitute therapy, that is, instead of getting the drug they ought to have, they get a drug that is available. When your life is in the balance this is not a pleasant thing.

The FDA keeps an on-line list of current drug shortages, which can be found here. The list is impressively long.

Many experts (the usual suspects) have looked into the problem of drug shortages, and have come up with many explanations for it. Typically, after analysis, the reason for the shortages is said to be “multifactorial,” and includes: insufficient production space, disruptions in the supply of raw materials, several drug makers opting out of the generic drug business, and a spate of manufacturing quality issues that have resulted in prolonged production interruptions. The term “drug company greed” often hovers just beneath the surface of such explanations, and sometimes actually breaches.

Here is the formal position the FDA has taken to explain the growing drug shortages. Readers will note that it invokes all of the above multifactorials.  (And since none of these manifold causes are under the direct control of the FDA, the agency concludes, clearly it is not to blame.)

This sort of scattershot explanation for the drug shortages seems unsatisfying. It seems unfocused and random. We are to believe that a series of disparate, unfortunate events suddenly began happening to the drug industry six years ago (since prior to that there was no particular problem with these drugs), with no underlying explanation, and that all these unwanted happenstances, quite miraculously, mainly affected only one kind of product – sterile, injectable generic medications. Go Figure.

Must be one of those Black Swan deals.

Undeterred by the lack of a unifying theory to explain the problem, the President has now taken action.

He decreed the following steps.  He told the FDA to ask drug companies for earlier notice when there will be a new shortage. He asked the FDA, after the agency has ordered a halt in production of a drug due to quality issues, to speed up its reviews when the drug company says it is ready to get back on line.  And he asked the DOJ to crack down on “grey markets” that have now appeared to provide these critical drugs to hospitals for exorbitant prices.

See what kind of quick action we would get if we would just suspend the Constitution?

The problem is that the things the President is doing won’t help much, and the things that would help a lot the President is not doing.

It should not be this difficult to figure out why we are having drug shortages. Yes, DrRich agrees that the proximate reasons are multifactorial. But the proximate reasons for product shortages are always multifactorial, because when the root cause of a shortage is itself beyond their control, the product-makers will always try multiple, marginally effective and often counterproductive ways to mitigate the root cause, thus creating a multitude of potential proximate causes for problems. And if an analyst does not look beyond those proximate causes he might not see the root. This often happens when seeing the root would be inconvenient or embarrassing.

The root cause of any persistent product shortage is almost always the same. For one reason or another, the cost of providing the product has outstripped the price the product-maker can get for selling the finished product.

In a free market, when the cost of production goes up the price of the finished product rises accordingly. As long as the customers can pay the higher price there will be no shortage of the product. If the price rises so high that customers won’t pay it, the demand for the product drops – and production is adjusted to reduce the supply in accordance with that reduced demand. But even in this case, there is no product shortage, because even if more product were available nobody would buy it.

Sometimes a sudden increase in demand for a product will create a product shortage. But the higher prices enabled by this new demand will entice the product-makers (greedy bastards!) to increase their manufacturing capacities, and will attract new product-makers to go into business, and eventually the shortage will be resolved. In free markets, shortages are usually temporary and self-adjusting.

In general, truly persistent shortages will only occur when the product-makers cannot increase the price they get for their finished product sufficiently to keep up with a rising cost of production. In this case profit margins shrink or even become negative, and the incentive to expand production, or even to stay in that business, disappears. This is a true shortage – the demand is still there, and customers are willing and able to pay the price being asked, but the product-makers are no longer able to supply the product at that price. Unless the mismatch between the cost of production and the price of the finished product is repaired, the product shortage becomes persistent or even permanent.

Such a persistent cost/price mismatch does not occur in a free market. It occurs when some Central Authority acts to control prices (often, to be sure, while simultaneously acting to increase the cost of production). A Central Authority can cap effective price a product-maker can get for his/her product by implementing overt or hidden price controls; by increasing marginal tax rates high enough to push the product-maker’s risk/reward calculation to favor inaction; and by instituting windfall profit taxes that do the same thing. DrRich is certain that Progressives have thought up a number of other ways to bolix-up the supply/demand relationship as well.

We do not need to know anything in particular about manufacturing generic, sterile injectable drugs to know that it is very likely that the persistent shortages we are seeing in these products are probably due to a persistent, externally-imposed mismatch between the cost of production, and the prices the companies can get for selling these drugs. And whatever caused that mismatch must have occurred before 2005.

And lo and behold! We find that a recent Medicare law (Section 303(c) of the Medicare Modernization Act of 2003) strictly limits the price Medicare will pay for “injectable” generic drugs. Prices for these drugs can still rise, but only by 6% or less, and only once every six months.  Congress (in its great wisdom and expertise in matters economic) made the judgment that this kind of price rise would be sufficient to balance market forces. But Congress was wrong.

This law took effect January 1, 2005.

The margins companies get for generic drugs are already low. And the cost of making (and managing the distribution of) sterile, injectable drugs is inherently higher than for most generic drugs. So the profit margins for these drugs, already low, was severely challenged by these new price controls.

The industry reacted quite rationally and predictably to this new law.  The big companies, which could maximize their profits by devoting their manufacturing space to other products, got out. And new, generic drug companies got in. These generic drug companies do not have to bear the cost of research and development, so their overall cost of production is substantially lower than for the big companies – their business models indicated they could pull a reasonable profit even with the price controls, if all went well. But to do so, they had to employ cheaper manufacturing processes, with less quality control and less production redundancy. So, quite predictably, there were quality issues, and when these issues occurred there was no redundant production capacity available to pick up the slack. And stringent new FDA standards meant that each time such an issue occurred, their production would be off-line for months, or even a year or longer.

But for DrRich to belabor the story from this point would only be to elaborate on the multitude of proximate causes for the drug shortages, all of which are merely artifacts of the ways the industry chose to respond to the root cause – i.e., to government-imposed price controls.

The President’s executive order ostensibly aimed at fixing the drug shortages will of course be ineffectual. While it implies new regulatory zeal which will further increase the cost of production and worsen the cost/price mismatch, it does not acknowledge let alone address the root cause.

In this light, the President’s attitude toward the grey market that has sprung up in response to the drug shortages is particularly instructive.  A grey market, as DrRich understands it, is like a black market but less illegal.  And we know a lot about black markets.

A black market acts outside the legal economy to provide customers with products they cannot get within the legal economy. The price a black market dealer gets for the product simply reflects current market forces, given the product shortages which exist within the legal economy, the risk the black marketeer takes in providing the product extra-legally, the additional “security” they require, &c.  So the customer pays through the nose, but at least he can get the product he wants or needs.

The very presence of grey/black markets generally indicates that the shortages which are present within the legal economy are not inherent but artificial – that is, the products are demonstrably available, for the right price. That product’s abundance would increase and the price would adjust to some more reasonable value if only the customer were permitted to pay what the market will bear. (The true free-market price for any black market product will always be far higher than the legal economy allows, but far lower than the black market demands.)

Fulminating about the greed of the grey marketeers does not hide this truth.

No wonder the President’s new decree attempts to convert the grey market for sterile injectables into a true black market, and in this way aims to snuff out this extremely embarrassing, all-too revealing, spectacle.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

If we are ever to gain control of our healthcare spending, which is a necessity if we are going to avoid an economic catastrophe during the next couple of decades, we have to come to some agreement, as a society, on a few essential questions.  Chief among these questions is whether healthcare is something we must consider to be a right for all Americans.

The question of whether healthcare is a right has become a very contentious one. One side passionately declares that of course it is a right, as healthcare is so critically important that how could it be otherwise? And the other side, with equal conviction, asserts that nothing can be a right that creates an involuntary burden on another.

That is, advocates on either side of the argument maintain their respective positions as being axiomatic, as primary and irreducible truths – which does not allow much room for discussion or debate. So instead of dispassionate discussion, we get vituperation. For, when one’s opponent denies an axiomatic truth, he declares himself to be beneath contempt, and unworthy of any degree of respect.

Regular readers will know that DrRich is a peacemaker.  Accordingly, he will attempt an apology for each of these mutually exclusive, fundamentally principled positions. He will follow this by a description of the pragmatic (as opposed to principled) position on the matter taken by our current leaders. Then finally, humble as ever, he will offer the “real” answer to the question of whether healthcare is a right.

The Conservative Position

Conservatives (and in most matters, DrRich is among this lot) think of “rights” in terms of “natural rights,” that is, in terms of rights which accrue to every person by virtue of the fact that they are members of the human race. Natural rights are generally considered to descend from the Creator (as the Declaration of Independence explicitly says), or at the very least from the inherent nature of the universe, and thus are not subject to addition or subtraction by any human authority – such as by governments.

Because natural rights are granted equally to every human, it follows that there is no such thing as a right that imposes obligations or limitations on the natural rights of others.

A right to healthcare would most certainly require an abridgement of the rights of others, and so there can be no right to healthcare.

The Progressive Position

Most Progressives do not explicitly deny the existence of natural rights, because doing so would cause them embarrassment when they assert their own inherent and unalterable “truths” (such as the superiority of “diversity” over all other human virtues). However, at their core Progressives do not (and cannot) actually subscribe to natural rights, since the Progressive program virtually requires a Central Authority to assign and distribute and enforce various differential “rights” to various groups, in order to achieve social justice.  And achieving social justice is the central requirement for Progressives to reach their ultimate goal of a perfect society.

To Progressives, creating healthcare equality among all Americans is critical to social justice. And so, it becomes axiomatic for them that healthcare must be a right.

It becomes immediately evident that any such “rights” granted under the Progressive program will necessarily create involuntary obligations upon at least some individuals. So it is likewise immediately evident that any “right” for Progressives will fundamentally violate the essence of a “right” for Conservatives.

This impasse, which occurs at the very first step of the discussion, is what prevents Conservatives and Progressives from engaging in any fruitful discussion of whether healthcare ought to be a right.

The Practical Position (The BOSS Rule)

Our current leaders have taken a more practical position on the question of a right to healthcare. They rely on the fact that “rights” are often bequeathed not because of some overarching principle (as with Conservative or Progressive thought), but rather, because of issues of practicality – or more straightforwardly, because the sovereign authority has the desire and the power to do so. They point out that throughout human history innumerable “rights” have been promulgated by the expediency of raw power.

We need only consider, during the course of human events, such widely acknowledged rights as the exceptional rights of the aristocracy (especially the divine rights of kings), the unique rights of the clergy, or the special rights of the Politburo (or the Congress).  The fact is that all of these rights clearly imposed more-or-less oppressive obligations on, and limited the individual rights of, the people. But that is not the least matter of concern. Rights become rights because the exigent authority has the desire to create them, and the capacity to exert violence wherever necessary to enforce them.

In this light, one might say that healthcare is a right in America simply because of the BOSS rule (Because Obama Says So). If Obama says healthcare is a right (and he has said so, many times), and has the raw power to back it up, then, by God, healthcare is a right.

The Correct Position

It is easy to see why the “healthcare is a right” debate has become so contentious – people mean entirely different things when they use the word “right.” A right to a Conservative is a natural phenomenon, awarded equally to all people and fundamentally unalterable by human hands. A right to a Progressive is an essential social construct, enumerated by enlightened leaders, which is necessary to further the principle of social justice. And to some non-ideologues a right is whatever the sovereign authority says it is.

To DrRich, none of these constructs are useful to solving our current problem of healthcare spending.

The Conservative position – that because healthcare cannot possibly be a natural right, therefore there is no right to healthcare – not only seems callous to a large segment of Americans, but (as DrRich will shortly demonstrate) is wrong. The Progressive and Practical positions – that healthcare is a right either because it is necessary to further the supreme cause of social justice, or simply because the Central Authority decrees it to be so – leave us in an untenable position when it comes to reducing healthcare spending.

That untenable position occurs because, when a “right to healthcare” is bestowed by the government, under either the Progressive program or the BOSS rule, that right is open-ended. It immediately takes on the characteristics of an entitlement, a grant bestowed on individuals by society because of the group to which they have been assigned (such as: citizens, residents, people over 65 years of age, a particular racial or ethnic group, etc.) That entitlement is to “healthcare” – that is, for whatever we can get the authorities (by whatever political maneuvering we choose to engage) to agree that “healthcare” includes, whether it is well-baby checks, artificial hearts, chemotherapy, extravagant end-of-life care, hair transplants, or cosmetic surgery. A right like this – an entitlement – is rarely taken away, or even limited, once granted. Entitlements are soon seen by their recipients (and by the vested interests that quickly spring up to defend those entitlements, such as the bureaucracy that regulates them, the companies that supply the products for them, and the healthcare professionals that administer them) as something that is owed forever, as a natural, God-given right, which can always be expanded, but never ever restricted.

DrRich, therefore, finds all these positions on a right to healthcare to be unhelpful. For this reason DrRich proposes a new position on a right to healthcare, a position which he humbly calls the Correct Position.

To wit: all Americans have an implied contractual right to healthcare. We have this right because we have long since entered into a contract under which, in exchange for implied considerations, we’re all paying for it.

Under the present healthcare system, a system we have devised over the past six decades through our duly elected representatives, every person living in the United States is sharing in the cost of healthcare for every person who receives healthcare. Since every American, in one or more ways, is paying for the healthcare of every American who receives it, every American has a just claim – a contractual right – to their fair share of that healthcare.

Let us list some of the ways in which Americans all share in the cost of all healthcare:

1) Anyone receiving a paycheck is subject to payroll deductions to pay for Medicare for the elderly and Medicaid for the poor.
2) Anyone paying income tax is paying higher tax rates to offset tax-deductible health insurance premiums purchased by businesses for their employees. (That is, employer-provided health insurance is subsidized by the taxpayer.)
3) Anyone buying products in the U.S. is paying higher prices to cover the healthcare costs of American businesses.
4) Anyone living in America is sharing in the massive societal burden we are creating by allowing healthcare spending to be passed off to future generations, by way of the national debt.

These costs, and more, are borne by everybody living in the U.S. And since all Americans are paying the cost of all healthcare – even the cost of so-called “private” health insurance – we all have a right, in the form a consideration under a contract, to claim some of that healthcare for ourselves. To deny this fact would void the contract.

It is important to note that this argument for a right to healthcare is fundamentally different from the arguments typically given. This contractual right is not “granted” to an individual by a beneficent society because of some inherent characteristic of the recipient, but rather, it exists solely because the individual is party to a social contract, created by the peoples’ representatives, under which healthcare is a consideration given in return for certain obligations the individual makes to society. Those obligations would include paying for the publicly-funded healthcare through taxes, and subjecting oneself to whatever limits to publicly-funded healthcare such a system requires in order to maintain societal integrity.

It is critical to understand that this kind of contractual right to healthcare enables us, legally end ethically, to set necessary limits on what we mean by healthcare. The “right” to healthcare is a contractual right, and not a natural right or an ethical requirement.  So, under that contract,  as in any contract between consenting parties, we have a duty to specify the limits of our mutual obligations, that is, to specify what we mean by “healthcare.” Furthermore, we have a duty to specify what we mean by “healthcare” in such a way that fulfilling the contract does not bring about national bankruptcy or otherwise cause societal destruction.

There would no longer be an obligation to provide individuals with every manner of available healthcare under all circumstances, but only to provide individuals with that level of healthcare which is provided as a public benefit to all other individuals, under the terms of the social contract. (An entitlement to healthcare, in contrast, traditionally is an open-ended promise in which “healthcare” comprises anything and everything one might think has any possibility of restoring every bit of health.)

To summarize, as DrRich sees it we have already created a contractual obligation to provide publicly-funded healthcare to all individuals, by virtue of the fact that we have burdened every individual in America with the cost of healthcare for anyone who is now receiving it. In contrast to the Conservative position, DrRich’s formulation recognizes a right that truly exists, by virtue of a contract that is unarguably in force, and that has been enacted over a long period of time through the offices of the people’s elected representatives. And unlike the Progressive position, DrRich’s formulation does not entrap us into an open-ended obligation to pay for all “healthcare,” however our collective sentiments may entice us to define that term.

We might as well own up to our responsibilities by openly recognizing : a) the universally-shared payments we all make to the cost of American healthcare: b) the right of all Americans to the considerations that arise from this universally-shared burden; and c) that it is right and proper for us to establish clear limits to the obligations borne by all the parties, as we must do with any legitimate contract.

The open recognition of this contractual right to healthcare will finally give us the framework we need for a public discussion on setting necessary limits on publicly-subsidized healthcare spending.

And this, DrRich most humbly submits, is the correct answer to whether healthcare is a right.

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

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

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

It was a cycle as natural as the seasons.

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

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

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

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

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

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

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

Hide the women and children!

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

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

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

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

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

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

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

The best known example is mitral valve prolapse (MVP), a congenital condition in which the mitral valve partially flops open when it should be closed, thus allowing blood to flow backwards (i.e., to regurgitate) across the mitral valve as the heart contracts. (For anyone interested, here’s a brief description of the heart’s chambers and valves.) Now, significant MVP can be a serious medical problem which requires mitral valve surgery. Fortunately, however, this kind of serious MVP is relatively uncommon.

But happily for cardiologists, echocardiography (a non-invasive test using sound waves to create an image of the beating heart) has become so advanced that some degree of trivial MVP, it seems, can be found in almost anybody. According to some studies, as many as 25 – 35% of healthy individuals – people without any cardiac problems or any symptoms whatsoever – can be said to have some degree of MVP. In fact, whether you have MVP or not depends largely on what criteria the echocardiographer uses to make the call, and how badly the referring doctor wants you to have the diagnosis.

Over the years it has become customary to diagnose MVP in young, apparently normal people who have the temerity to complain about the highly disruptive symptoms of dysautonomia (such as fatigue, weakness, strange pains, dizziness, constipation, diarrhea, cramps or passing out), without supplying the kinds of objective physical or laboratory findings which, doctors insist, patients are always obligated to provide. Such thoughtless patients are now routinely sent for echocardiography, so that MVP can be diagnosed (since it can be diagnosed just about whenever it is looked for). The patient is then given the diagnosis of “mitral prolapse syndrome,” even though: a) the MVP is usually so trivial as to be nonexistent; b) the studies which claim to show an association between MVP and these sorts of symptoms are generally based on a gross over-diagnosis of MVP; and c) there is no credible theory based on actual physiology to explain how MVP – even real MVP, much less the trivial kind – might cause such symptoms.

But no matter. “Rule out MVP” has become one of the most common reasons for young, healthy people to be referred for echocardiography, and has become a stable source of income for cardiologists.

The story is similar for the association between patent foramen ovale (PFO) and migraine headaches.

In the developing fetus, the foramen ovale is a hole that is present in the atrial septum (the thin structure that separates the right atrium from the left atrium). At birth, a flap of tissue imposes itself over the foramen ovale, causing it to close. In some people, however – people with PFO – the tissue flap is still capable of flopping open. In people with PFO, the foramen ovale can open for a few moments if the pressure in the right atrium becomes transiently greater than the pressure in the left atrium, such as with coughing, or straining during a bowel movement.

In rare instances, strokes in healthy young patients have been attributed to PFO. The supporting theory is that a stroke can occur when a blood clot happens to be coursing through the right atrium at the precise moment when a person with PFO is coughing (for instance), allowing the clot to move into the left atrium, and on to the brain. And because this theory is at least plausible, in a young person who has an unexplained stroke and is then found to have a PFO, it makes at least some sense to close the PFO.

But the presence or absence of a PFO is a little like the presence or absence of MVP. Its diagnosis depends to some extent on how hard the echocardiographer looks for it, and on how much the referring doctor would appreciate the diagnosis. With modern echocardiographic equipment, at least some sign of PFO can be found in as many as 25% of normal individuals.

Being able to make this nifty diagnosis would be of little use to cardiologists if the only clinical problem it may cause is a one-in-a-million chance of stroke. One cannot make a living, or even make a decent car payment, doing echocardiograms in those extremely rare young patients with cryptic strokes. So it didn’t take long for cardiologists to draw a more useful association – this time, between PFOs and migraine headaches.

While all the things that have to happen in order for a PFO to cause a stroke are very unlikely, at least one can assemble a string of very unlikely events that, should they all occur simultaneously, might possibly produce a stroke. This is not the case with migraine. No plausible theory has been advanced to explain how PFO might cause migraines. The only reason PFO is being invoked as a cause for migraine is that when patients with migraine have been carefully studied for the presence of PFO, an increased incidence of PFO was found. (But again, when PFO is carefully sought in any population of patients, it is more likely to be found.) The only likely reason PFO has not been associated with cancer, red hair, type A personality, or difficulty in memorizing the multiplication tables is that cardiologists have not thought of looking for it (yet) in these conditions.

For cardiologists, the poorly-supported allegation that PFO causes migraine is particularly compelling, since not only can they get paid for the echocardiograms to look for PFOs in migraine sufferers, but also there is an invasive (and lucrative) procedure they can do to close PFOs, to “treat” the migraines. Studies to date have not been successful in showing that closing PFOs improves migraine headaches, but that hasn’t kept cardiologists from screening migraine patients for PFO, then offering them PFO closure as a therapeutic option.

Migraine sufferers are particularly vulnerable to this and many other unproven therapies, since they are often disabled by their condition, and in many cases medical science (or medical ignorance) offers them insufficient help. Consequently, anecdotal stories abound regarding unorthodox therapies that cure migraines. (DrRich, himself a migraine sufferer for many decades, has heard them all.) One undeniable truth is that merely performing PFO closures on enough migraine suffers is guaranteed to produce a patient here or there who will report a positive response. And despite the continued negativity of actual clinical trials so far, that’s what happened.

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

But now it gets even worse for the neurologists. Any who ignored the cardiologist’s usurpation of dysautonomia, and who may have felt only a little more concern when cardiologists began to lay claim to migraine headaches, had best sit up and take notice. Because now, cardiologists are laying claim to Alzheimer’s Disease.

Recently, researchers presented a study suggesting that ablation procedures for atrial fibrillation are associated with a lower risk of subsequent Alzheimer’s disease. (Here’s some information on atrial fibrillation and its treatment if you are interested.) The study was presented as an abstract only, so we know relatively little about the specifics.

But, really. Atrial fibrillation and Alzheimer’s are both disorders associated with aging, so it is not surprising that they are associated with each other – in the same way that atrial fibrillation is associated with gray hair, cataracts, and bunions. Ablation for atrial fibrillation is a relatively lengthy and difficult procedure, whose results are relatively middling, and which carries a substantial risk of some really nasty complications. So these ablation procedures are generally reserved for carefully selected, reasonably ideal candidates – usually, the relatively young, relatively healthy atrial fibrillation patients, who are less likely to get Alzheimer’s disease over the next few years whether they have ablations or not.

So there is a lot to be cautious about in interpreting a preliminary study like this one.

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

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

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

You see how this works?

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

You can’t fight the Feds. When the Central Authority, at the point of a gun, decides to reach down into the world of the medical specialists, and dictate which medical services are no longer going to be feasible (all for the noblest of purposes, of course), the affected medical specialists have a limited range of possible responses. And fighting the Feds is NOT among these available responses. It would be more effective – and certainly safer – for doctors to fight against the change of the seasons.

So the affected specialists have only two options. They can contract their horizons, take what’s left, and try to make the best of it. Or, they can do what the Visigoths did when the people of the steppes fell upon them. Strike out against other, weaker tribes and take what’s theirs.

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

In the meantime, DrRich remains supremely confident that his cardiology colleagues can find a nearly unlimited supply of plunder in this brave new world. They are very robust barbarians.

Q: What’s the difference between a public health expert and an ax murderer?

A: Actually, there are two differences. The public health expert usually means well. And the public health expert has only metaphorical blood on his hands.

In a prior post DrRich related how public health experts, displaying every ounce of the overblown self-confidence traditionally enjoyed by the expert class operating within our Progressive institutions, have wreaked all manner of harm upon our society with their premature promotion of Low-Fat Diets, an action which, DrRich argued, is at least partly responsible for triggering our current epidemic of obesity (and therefore, according to some respected experts, global warming).

As if causing the rotundity of the American populace (and again, with less certainty, the impending destruction of our planet) was not enough, it is now beginning to appear as if another major public health initiative, an initiative with which we have all been pummeled mercilessly for over two decades, also may be based upon a faulty premise.

DrRich speaks, of course, of the long crusade which the experts have preached, and which we among the faithful have doggedly waged, against cholesterol. While nobody is talking about it, it is beginning to appear (to DrRich, at least) as if the fundamental hypothesis underlying our long war on cholesterol is far less solid than we have been assured.

DrRich is moved to describe his uneasiness with the cholesterol hypothesis at this time because, last week, yet another nail was driven into its coffin.

The Cholesterol Hypothesis

Our war on cholesterol is based on the cholesterol hypothesis, which states that an elevated cholesterol blood level is a major cause of atherosclerosis, and therefore of heart attacks, strokes and peripheral artery disease. The hypothesis goes on to describe two major species of blood cholesterol – LDL cholesterol, or “bad” cholesterol, which increases cardiovascular risk; and HDL cholesterol, or “good” cholesterol, which reduces cardiovascular risk.

According to the cholesterol hypothesis, the LDL cholesterol molecules deliver excess cholesterol to the lining of the arteries, where it gradually accumulates, leading to the buildup of the plaques that obstruct blood flow. HDL cholesterol represents cholesterol that has been removed from those plaques (so the higher the HDL level, the more cholesterol is being removed)

Therefore, it behooves every American to work assiduously to reduce our LDL cholesterol levels and increase our HDL cholesterol levels.

This, of course, has become more than merely a suggestion or recommendation. Under our new incipient universal healthcare paradigm, in which your suboptimal health habits directly affect the healthcare services which will be available to me, your failure to control your cholesterol and your subsequent utilization of precious healthcare resources amounts to attempted murder, and is therefore a grave crime against humanity.

The cholesterol hypothesis is based upon two observations gleaned from clinical research. First, that high LDL cholesterol levels are significantly associated with the risk of heart attack, &c. (and that high HDL cholesterol levels are associated with reduced risk); and second, that lowering LDL cholesterol levels (or increasing HDL cholesterol levels) with drug therapy lowers that risk.

It was this second observation that “clinched” the cholesterol hypothesis for the public health experts (and most doctors).  And this second observation is based virtually entirely on the statin drugs. Until the statin drugs were first developed – drugs that powerfully and reliably reduce cholesterol levels – it had never been convincingly demonstrated that lowering cholesterol levels actually did any good.

And so, according to the cholesterol hypothesis, every American is obligated to work to maintain “healthy” cholesterol levels. In general, we are urged to begin with diet and exercise, and if that does not work (and depending on the level of our cardiovascular risk) we are likely expected to begin on drug therapy.

But DrRich suggests (reluctantly, since by doing so he undoubtedly invites even more personal attacks against his intellect, honesty, personal appearance, parentage, &c.), that the cholesterol hypothesis may not be correct.

Evidence Against the Cholesterol Hypothesis

1) Despite several clinical trials showing that the kinds of lifestyle modifications which are officially  recommended for the reduction of cholesterol can in fact reduce LDL cholesterol levels, it has not been shown that such lifestyle-induced cholesterol reductions lead to improved clinical outcomes.

2) Early (pre-statin) cholesterol-lowering trials (using clofibrate, cholestyramine, and gemfibrozil) were unable to demonstrate that an improvement in cardiovascular mortality accompanies a reduction in cholesterol levels, and indeed, each of these studies showed an unexpected increase in non-cardiovascular mortality with the cholesterol-lowering drugs.

3) More recently, studies showed that adding the powerful non-statin cholesterol-lowering drug ezetimibe  to a statin drug not only failed to improve outcomes, but also (unexpectedly) may have led to more plaque growth than was seen with the statin alone. (Ezetimibe is marketed as Vytorin in those god-awful commercials comparing your Aunt Helen to a strawberry cheesecake.)

4) Just last week, the NIH prematurely halted a high-profile study (the AIM-HIGH trial) comparing statin to statin + niacin in patients with cardiovascular disease and low HDL levels. (This study was designed to show that increasing HDL levels with niacin would improve outcomes.)  The study was stopped 18 months ahead of schedule not only because it was determined to be extremely unlikely that the increase in HDL produced by niacin would improve outcomes, but also because of an unexpected increase in strokes among the patients receiving niacin.

5) Numerous trials using statin drugs have demonstrated that these drugs can reduce cardiovascular events and improve cardiovascular mortality – without an increase in non-cardiovascular mortality – in patients who have known heart disease or who are at increased risk for heart disease. However, the mechanism by which statins provide these benefits may have little or nothing to do with their cholesterol-lowering effects. (Statins have several mechanisms of action under which they can improve cardiovascular outcomes, including stabilizing plaques, improving endothelial function, reducing intravascular blood clotting, and reducing inflammation. Each of these mechanisms can directly and immediately reduce the risk of heart attack and stroke – more directly and immediately, one must concede, than by merely reducing cholesterol levels.) So, for instance, when statins are administered during acute coronary syndromes, their benefits are seen immediately – an effect not explained by the cholesterol hypothesis.  Further, the JUPITER trial showed convincingly that statins can improve outcomes even in patients with “normal” cholesterol levels, which is also not explained by the cholesterol hypothesis.

In summary, lowering cholesterol by any method other than statins has not been shown to significantly improve outcomes.  And evidence indicates that the chief benefit of statins may be imparted by the drugs’ non-cholesterol-lowering mechanisms.

These observations suggest an alternate hypothesis.

The Bear Shit Hypothesis

If you are walking in the woods and you see bear droppings, your chances of being eaten by a bear are much higher than if there were no bear droppings. But if you take out your (legally registered) firearm and shoot the bear droppings, you have not improved your risk at all.

DrRich maintains that the totality of the data regarding cholesterol, as it exists today, is entirely consistent with the bear droppings hypothesis.  That is, elevated cholesterol levels may (and certainly do) indicate a higher risk of cardiovascular disease, but may not themselves be a causative factor.

Indeed, the bear shit hypothesis can explain the facts as we know them much better than the traditional cholesterol hypothesis. The bear droppings hypothesis can explain why treating cholesterol with any of several methods (aside from statins) fails to improve risk.  (While cholesterol is associated with atherosclerosis, it may not be a critical cause of atherosclerosis.)  Since discharging one’s firearm at bear droppings might awaken a sleeping bear, the bear droppings theory is also consistent with the fact that reducing cholesterol with virtually any drug save one of the statins may actually worsen outcomes (by creating sundry “unexpected” medical problems of one variety or another).

That is, unless you are using statins (which have several important therapeutic effects unrelated to reducing cholesterol, and which in high risk patients far outweigh – statistically speaking – any side effects these drugs have), treating cholesterol levels with drugs may turn out to be a bad idea.

The Bear Shit Hypothesis, being merely an hypothesis, may not be correct, either. But it seems to fit the existing clinical evidence at least as well as – and DrRich suggests, better than – the cholesterol hypothesis. And at least DrRich admits his hypothesis may not hold up at the end of the day, and does not insist that all his fellow citizens drop what they are doing and rearrange their entire lives to comport with its implications.

Where Does This Leave Public Health Experts?

For over 20 years, the cholesterol hypothesis has been presented to the public, with all the evangelical fervor employed by the global warming experts, as settled science.  There is clearly some muttering going on these days amongst the experts – in their private conclaves – about certain “anomalies” that have appeared in the clinical database over the past decade or so, anomalies which have muddied the nice, clear cholesterol hypothesis they have so forcefully promulgated for so many years. They are desperately trying to explain away these anomalies by subdividing LDL and HDL cholesterol into more and more complex “subspecies” that have “counter-intuitive” behaviors. (This latter effort has the benefit of being so mind-numbingly complex that nobody can follow it – which means that it is difficult to assert with any authority that it’s all folderal.)

In the meantime, because statins are effective at reducing cardiovascular mortality and morbidity, and because statins also (quite possibly as an unrelated side-effect) reduce cholesterol levels, the experts can continue to trumpet their cholesterol hypothesis to an unsuspecting public, with the caveat that statins ought to be the drug therapy which one should try first. They have not yet reached the point where they are willing to say that if statins are not tolerated, one should probably not attempt to reduce cholesterol levels with any of the non-statin drugs (i.e., with drugs that merely reduce cholesterol).

And so, for the second time we see that a massive public health campaign that has been whipped up by the expert class is likely to turn out to be a wrong-headed “experiment,” one which so far has been conducted on the entire population for more than two decades.  This time (and in distinction to the low-fat diet “experiment”) it appears that little widespread harm has been done. But this result is fortuitous, and is most likely related to the fact that statin drugs turn out to help prevent the rupture of atherosclerotic plaques by means apparently unrelated to their cholesterol-lowering abilities.

What will the experts do if the cholesterol hypothesis finally is proved to be mistaken? It is easy to predict. They will stick tenaciously to their cholesterol hypothesis until the last possible minute, then if and when they at last find it to be utterly unsupportable, they will simply move on to the next hypothesis as if the old one never existed.

For one thing we know with certainty about the expert class is that they are never chastened. Their low-fat diet dogma simply and smoothly elides into a Mediterranean diet mantra (a diet, as it happens, with plenty of fats). Their demands that “safe” trans fats be substituted for saturated fats in processed foods simply transforms, 10 years later,  into indignant demands that the trans fats be removed when it is discovered they are worse than saturated fats. The phrase “global warming” is simply dropped in favor of “climate change” when it is discovered that the planet actually has been cooling since the 1990s.  In no case is there an acknowledgement that their prior expert pronouncements have been both arbitrary and wrong, and much less is there ever an apology. Being experts, and thus by definition correct, they never, ever have anything to apologize for. They simply abandon the old dogma as needed, and seamlessly adopt the new one.

For when you’re an expert within our multiplicity of institutions for public improvement, history will always have begun 10 minutes ago.

In response to DrRich’s recent post on good debt vs. bad debt, Liz writes:

Is the survival of the individual, after consuming healthcare, necessarily neutral to our national economic health? On the one hand, if an individual is saved from death by consuming healthcare and goes on to be very productive in life, then that healthcare would have been a good investment. On the other hand, if someone else is saved by doctors, only to go on to require more and more medical care without contributing anything to the collective, then the individual’s survival has a negative impact on the nation’s economic health. . . . Some people will argue that keeping people healthy is a good investment for our country.

This comment was triggered by DrRich’s premise (modeled after Alexander Hamilton) that for the federal government to acquire certain kinds of debt – say, borrowing money to build a new hydroelectric plant that will supply electricity to a large region of the country and thus enable sustained economic expansion – is truly a positive investment for future generations, and is thus justifiable; while aquiring certain other kinds of debt – for instance, purchasing goods or services for individuals, which the individuals then consume in the normal course of their lives – leaves nothing for future generations aside from the accumulated debt, and thus is fundamentally unjustifiable.

Liz rightly points out that not all the debt we accumulate to pay for Americans’ healthcare is of the latter variety. It is certainly true, for instance, that going into federal debt to purchase a liver transplant for Steve Jobs would end up being a positive investment over time. There are certainly many people less notorious than Mr. Jobs – possibly millions – who might also fit into this “good investment” category.

So, Liz’ comment implies, it may be that increasing the federal debt to buy healthcare for Americans – at least some Americans if not all* – actually constitutes a good investment, and therefore good debt.

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* Progressives, despite their protestations to the contrary, have actually given a lot of thought to which individuals should receive priority for healthcare services once they have the single-payer (centrally controlled) system they have long desired. They have occasionally, in unguarded moments, opined publicly on which sorts of Americans should receive expensive healthcare services and which should not. Their proposed rationing methodology indeed shunts healthcare services to those individuals who are judged to be “productive” by the Central Authority.  In their 100-year history Progressives have never been slow to pass harsh judgment on the worthiness of various groups or individuals, and there is no sign that they will behave any differently going forward. (DrRich, even if he were not an old fart, fears he would not wind up in the Central Authority’s “good” list.)
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There are certainly examples of Americans happily agreeing to pay collectively for services consumed by individuals, because doing so is a good investment for the future. Chief among these is public education. Unarguably, an educated public is critical to continued economic growth and development, so (leaving aside for now the actual effectiveness of public education) paying collectively to educate all American children unquestionably benefits all current and future Americans.

Some would even argue – and DrRich would agree – that maintaining a certain level of health among the population is just as important to continued economic growth as is public education, and so paying collectively to achieve such a thing is equally a good investment. This is why DrRich fully supports many collective efforts to assure public health, such as assuring clean water, keeping air pollution to a minimum, and maintaining a healthy and safe food supply.

But DrRich’s thinking on the matter is even more radical than that. DrRich believes that it is indeed reasonable, and likely a good investment for the future, to use collective funds to pay for some of the healthcare consumed by individual Americans.  If Americans know that, no matter what their socioeconomic status, they are unlikely to become financially ruined because of some expensive medical catastrophe, they will be more willing to take the risks one traditionally takes (under a vibrant capitalist system) to grow one’s own wealth – and the overall economy.

So, to some extent, DrRich believes that collective spending on the healthcare of individual Americans can indeed be an investment for the future, just as President Obama says.

But the key phrase here is “to some extent.”  That is, we cannot furnish every bit of desirable healthcare for every individual, because that way lies ruin. We must set limits. DrRich has a simple rule for determining when our collective spending on healthcare is “too much.”  Our collective spending on healthcare is too much when the level of debt we’re accumulating to pay for healthcare is sufficient to threaten the economic destruction of our society. Triggering societal collapse, DrRich thinks, completely negates any “investment value” we might obtain by purchasing healthcare for individuals.

The healthcare system we have today, and the one we will have under Obamacare (at least, the kind of Obamacare that Progressives will admit to at this point), exceed even this very modest definition of “too much.”

DrRich has proposed a structure for an American healthcare system that would offer healthcare to each individual, without accumulating an unsustainable debt, and he has described it in detail in his book. Simply put, it is a 3-tiered system. In Tier 1, individuals would pay for (say) the first $3000 per year of their own healthcare expenses. Tier 1 spending would be funded from a tax-deductible, self-funded, self-owned Health Savings Account. Individuals below a certain income level would have their HSA funded by the government. Tier 2 would be a government-funded universal basic health plan, under which most additional healthcare expenses would be covered.  However, in the interest of keeping federal debt to a manageable level, Tier 2 would function under an open, completely transparent system of rationing. While most things would be paid for, some would not. The rationing system would allow the government to control how much it spends on healthcare each year, thus avoiding the crushing debt burden we are accumulating today. Tier 3 would be an optional, self-funded health insurance product that would cover extraordinary expenses that exceed the $3000 per-year individual limit, and are not covered under the Tier 2 rationing plan. Tier 3 would return the health insurance industry to the business of selling an actual insurance product (that is, a product that prevents individuals from financial ruin due to relatively unlikely future events), instead of whatever it is they’re selling today.*

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* Thus, DrRich’s plan would give the insurance industry what it desperately needs – a new business model – without having to sell out to the Central Authority and survive under the diminished status of public utility.
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Conservatives hate DrRich’s system because it includes a universal health plan. Progressives hate DrRich’s system because it does not offer enough centralized control, and indeed encourages (even demands) that individuals take chief responsibility for their own healthcare. So DrRich does not reiterate his plan for healthcare reform because he thinks it is even remotely possible that such a thing will ever be adopted, but simply to illustrate that it is indeed possible, with just a little effort, to imagine a healthcare system that actually meets the goals that Progressives and conservatives will admit to in public – and that honors the worthiness and the potential of each individual.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CMS knows exactly what it’s doing here.

In the wake of another sudden death in a another young athlete, the question arises – as it does after each of these tragic events – whether all young athletes should be screened for occult heart disease before participating in sports. It appears, for instance, that 16-year-old Wes Leonard had an underlying heart condition which likely could have been identified with a simple echocardiogram.

The question is controversial, and accordingly, even the professionals disagree. The European Society of Cardiology and the International Olympic Committee, for instance, recommend screening every young athlete with electrocardiograms (ECGs), and if the ECG is abnormal, following with an echocardiogram. But the American Heart Association and the American College of Cardiology do not recommend screening ECGs, and advocate only a medical history and physical examination – which will notoriously miss many if not most of the occult cardiac conditions that produce sudden death in young athletes.

To DrRich, of course, sorting through the controversy is mere child’s play. Allow him to explain.

The problem in answering this question stems solely from our failure to clearly identify what we wish to accomplish in establishing such a screening policy.

Those who advocate widespread screening stress the horrific nature of sudden death in vital young people.  They can fully articulate their argument simply by pointing to the awful video of young Wes scoring the winning basket to cap off a perfect season, then moments later, collapsing and dying. The scene is just too gut-wrenching to watch. Clearly, we should all want to do whatever we can to prevent such scenes from ever happening again. If Mr. Leonard had had an echocardiogram, it is likely that this tragedy might not have happened – and that should be argument enough for a widespread screening program.

For a good articulation of the alternative point of view we can begin by turning to DrRich’s colleague, Dr. Wes. Wes points to the experience of a Detroit area hospital that screened 5200 young student athletes, and identified three who had cardiac abnormalities which placed them at risk for sudden death. In finding these three individuals, the screeners not only performed ECGs on all 5200 students, but also performed nearly 1000 echocardiograms on students with suspicious ECGs, and in the process identified at least 30 students who needed even further evaluation (and possibly treatment). Evaluating these other, possibly false-positive cases not only cost money, but also subjected these young students to medical risk. Dr. Wes estimates the overall cost of this screening process at well over $600,000, and Wes is being very conservative in his assumptions.  As a result of this well-intentioned effort, it appears that several kids were told not to participate in sports any more; it is not clear that any lives were actually saved.

As it happens, a report from Israel this week in the Journal of the American College of Cardiology substantiates Wes’ suspicions. According to this study, the national mandatory cardiac screening program for athletes, instituted in Israel in 1997, seems not to have reduced the incidence of sudden death in young athletes at all. The incidence of sudden death was 2.6 per 100,000 athlete-years both before and after the mandatory screening was instituted.

Does this mean that screening does not save any lives? No. It is certain that some individuals are spared sudden death thanks to this aggressive type of screening program – just not enough to affect the overall statistics. This result illustrates that when you are dealing with an event that has such a low incidence of occurrence, it is extraordinarily difficult to prove that your intervention is producing a statistically significant reduction in that incidence.

Furthermore, by definition, screening programs of any type (whether it’s screening for sudden death in athletes or screening for breast cancer) don’t change outcomes. All they do is identify people at some degree of increased risk. To change the outcomes, you have to find a way of treating the at-risk individuals you’ve identified with some process that is sufficiently effective, that itself does not worsen outcomes, and that the at-risk individual is willing and able to employ.

In the case of screening young athletes, to effect a reduction in the rate of sudden death you must either convince the young person to give up sports (not only organized sports, but all athletic activities), or find a way to make the underlying heart condition go away. DrRich understands that some of his readers might not have experience in trying to convince dedicated young athletes to stop what they’re doing and become bookkeepers, but the fact is that informing them of the risk is not always perfectly effective in changing their behavior. And while most of the cardiac conditions that produce a risk of sudden death in these young people can be managed to one degree or another, they generally are not “cured” or mitigated to the extent that athletic activity becomes risk-free.

So, while occasional individuals are likely to benefit substantially from these screening programs, if you look at it from the collective point of view these programs appear to do little or no measurable overall good, despite the high cost.

So this brings us back to the original question – should routine cardiac screening of athletes be performed? It seems clear, to DrRich at least, that the answer is: It depends on what you are trying to accomplish.

If you are asking the question from a collective viewpoint, wherein “society” will be paying the bills for the screening procedures, and thus will not have that money any longer to spend on other healthcare services that might yield a more substantial result, it is obvious (since there is no measurable benefit but a high cost) that such screening should not be done.

But if you are one of the individuals – or the loved one of such an individual – who is concerned about having a readily identifiable cardiac condition which places you at risk for sudden death, and would be willing to change your behavior if you are found to be at high risk, it would be entirely reasonable for you to want cardiac screening, and furthermore you should have every opportunity to avail yourself of that screening.

So what we have here is that very common circumstance, which modern medical ethicists insist never ever occur, wherein what is clearly best for an individual is equally clearly not best for the collective.

This situation, DrRich thinks, is analogous to the situation with smoke detectors. Smoke detectors clearly save lives here and there – we have all heard anecdotes about a family being aroused to safety by a smoke detector. But proving that the overall incidence of death from fire has been significantly reduced in the era of smoke detectors seems difficult if not impossible. And if it were society’s job to buy smoke detectors for every individual, then society would – rightly – determine that the cost is not worth the insubstantial benefit.

Yet, everybody has smoke detectors. Why?

Simply, everybody has smoke detectors because it is NOT society’s job to pay for them. The individual does. And the individual does not care that smoke detectors cost $1.2 million per life saved. They only care that the life saved, potentially, is theirs, and that owning the smoke detector that might just save their life does not cost them $1.2 million, it only costs them $19.99.

The issue of screening young athletes would be resolved if we made screening ECGs readily available to individuals for $10 at Walmart, and a follow-up echo (if needed) for $50, also at Walmart. Then individuals who decide that they wanted to know if they’re at risk for sudden death could do their own cost-benefit analysis, and if the potential benefit is worth a few dollars to them, they could buy the screening for themselves.

So screening young athletes for underlying cardiac conditions seems like a pretty good idea, just like smoke detectors seem like a pretty good idea. Where we go wrong is by making such screening a medical service, and therefore making it the responsibility of the collective to pay for it (if indeed it is to be purchased), and furthermore, making it next to impossible – and soon illegal – for individuals to pay for it themselves.

From the collective point of view, paying for the screening of young athletes makes no more sense than would collectively purchasing smoke detectors, carbon monoxide detectors, fog lights, back-up cameras, home security systems, and a host of other personal safety-enhancers that people will happily pay for themselves, but which would be ridiculously wasteful to pay for collectively.

Which just goes to illustrate a general rule: The more stuff we collectivize, the less stuff we’ll have.

When DrRich decided to become an electrophysiologist over 30 years ago, it was because he wanted to help figure out how to prevent sudden death.  Sudden death from cardiac arrhythmias is estimated to kill over 300,000 Americans each year, and at the time, some of the more recent victims of sudden death had been DrRich’s friends or loved ones. Because cardiac arrhythmias – even the lethal ones – can virtually always be stopped if appropriate interventions are available, these deaths can be prevented, at least in theory. DrRich wanted to help turn the theory into reality.

In 1982, by virtue of being in the right place at the right time rather than by virtue of his own qualities or qualifications, DrRich’s electrophysiology shop at the University of Pittsburgh became the third institution in the world (after Johns Hopkins and Stanford) to gain access to the highly experimental implantable defibrillator. The gradual development of the implantable cardioverter defibrillator (ICD) from a primitive and often dangerous device that was suitable only for the very highest-risk patients, to the finely-tuned life-saving instrument it is today, is an amazing story in itself. Perhaps some day DrRich (who was in the thick of it for two and a half decades) will try to tell it.

But the bottom line is that today we know how to prevent sudden death. And if the evolution of ICDs were permitted to follow the path which is followed by most modern technologies, these devices could, relatively quickly, become small enough, simple enough, safe enough, effective enough, and cheap enough for the kind of widespread usage which would be necessary to actually produce a large reduction in those 300,000 deaths per year. The ICD companies all know how this could be accomplished, and for that matter, so does DrRich.

But alas, this is not going to happen. ICDs will remain extraordinarily complex and expensive devices, which can only be wrestled to ground by highly-trained electrophysiologists (EPs), and which therefore will only be available to a very tiny proportion of the people who could benefit from them. And rather than being celebrated as the typical American success story of harnessing vision, persistence, and innovation to solve a very difficult problem, ICDs instead are widely castigated (by the press, the public, the insurers, the government, and even most doctors) as a symbol of excess, as the poster child for expensive and wasteful medical technology. (And so, when the DOJ goes after ICD companies and the doctors who implant them, the press and the people cheer them on.)

While most EPs and all of the ICD companies refuse to see it, ICDs – a remarkable technology which prevents an all-too-common tragedy – have become an abomination in the eyes of our society.

There are many reasons for this. DrRich will list just three of them, in ascending order of importance.

The third most important reason ICDs are an abomination is: The Toxic Symbiosis Between ICD Companies and Electrophysiologists.

EPs were important during the initial years the ICD was being developed, since expertise regarding complex cardiac arrhythmias had to be translated into engineering language, and then packed into the ICDs, in order for these devices to work the right way. But at some point in the 1990s, ICD companies should have realized that EPs had made their contribution, and were now leading them out on a limb.

Once the fundamental problems in building ICDs were solved, the companies should have been working to make their devices simpler to use, more reliable, and cheaper, so that they could be used by more doctors in more patients. Instead, following MBA Dictum Number One, they “listened to their customers,” the EPs. And the EPs (for whom, like most medical specialists, turf protection is very high up on their priority list), unfailingly counseled the ICD companies to make these devices more and more complex, so that only EPs can understand how to use them. And so, this is what the ICD companies did.

As a result, today’s typical ICD has extra leads (wires) which add appreciably to the difficulty and the risk of implanting these devices, without adding much practical value for most patients; and they have incorporated literally tens of thousands of programming options, ostensibly so that device function can be carefully “tailored” for the individual patient, but which are seldom actually used profitably, and whose chief effect is scaring off non-EPs.

By “listening to their customers,” ICD companies have been led away from simplicity and into unnecessary complexity, and today’s typical ICD is burdened with layers of grotesque tailfins, running lights, oversized tires, and massive engines. In building their vehicles, the ICD companies should have solicited the needs of the typical commuter; instead, they consulted only with monster truck enthusiasts, and so they are producing vehicles that are not suitable for highway use.

The second most important reason ICDs are an abomination is: Government Price Controls (As Usual) Are Keeping Prices High.

The price of ICDs, fundamentally, is determined by Medicare. Way back when ICDs were first approved for use, Medicare determined that a fair price was somewhere in the range of $15,000 – $25,000. This high price was justifiable back in the 1980s, since it cost nearly that much at the time to make one of these things. But the way government price controls seem to operate, ICDs will probably remain in this price range forever.

Now, to be sure, the government does not directly determine what companies get paid for ICDs. Rather, they indirectly determine the price by deciding what hospitals and physicians will be reimbursed for implanting ICDs – and the ICD companies subsequently are paid by the hospital. Those Medicare reimbursement rates apparently vary substantially from region to region and hospital to hospital (who knows how the government determines these things?), and the various rates are not publicly available to DrRich’s knowledge. But ICD manufacturers, at worst, can impute the reimbursement rates by figuring out the top price which specific hospitals are willing to pay them for ICDs (hence the range in prices).

Having determined the top price they can possibly get paid for ICDs, the only logical strategy for manufacturers is to figure out how they can always get paid that top price for every device they sell. They do this by making ICDs specifically aimed at keeping the decision makers happy. And the decision makers, as we have seen, are the EPs.

EPs, having (so far) successfully protected their turf, most often decide which patients get ICDs, and they decide which company’s ICDs to implant. So, to be competitive among their customers, ICD companies must cater to the wants and needs of EPs, and so must produce a steady stream of new, improved ICDs whose novel features are requested by these very high-end, high-maintenance physicians (who again, are dedicated to turf protection through complexity).

Since their product therefore grows more complex with each succeeding generation, in response to the “needs” of their customers, ICD companies have been able to successfully argue to Medicare that ICD reimbursement should be maintained at high levels (and in some cases they have been successful in getting reimbursements to increase even further).

All the ICD manufacturer needs (and wants) to know is: what new geegaws do I need to add to my next generation of ICDs in order to make them even more stupefyingly complex, so as to maintain the loyalty of my EP customers, and to justify high reimbursement rates?

And this is why, despite the fact that ICD technology has been fully mature (says DrRich) for at least a decade now, which in a functional market would cause the price to plummet, the cost of ICDs remains so high. Whatever has developed in the complex interplay between ICD manufacturers, EPs, hospitals and the government, it’s not a functional market.

In fact, there are no market forces at all in play here. Furthermore, there is no evil-doing. The “players” in this scenario – CMS personnel, ICD manufacturers, and EPs – are all simply behaving logically, and are all responding as anyone would to the incentives that have been established within a system which employs government price controlls to keep costs down.

As a result, ICDs remain extraordinarly and unnecessarily expensive.

And the number one reason ICDs are an abomination is: Sudden Death Is Good Public Policy.

A well-known and often-repeated assertion is that 75% (or some similar high proportion) of all healthcare expenditures are consumed during the last six months (or some similar brief interval) of life. Whenever this assertion is made, the clear implication is that some means ought to be found to stop wasting all those healthcare resources, once that six-month clock is found to have started. The debates as to how to go about doing this (since the initiation of the six-month clock can really only be determined retrospectively) often become very nasty, very quickly.

In this light, consider sudden death. Sudden death has the virtue of being completely unexpected – and therefore very cheap. Victims of sudden death will not have spent the last six months of their lives selfishly consuming all our healthcare resources. Likely, they will have spent that time earning money, consuming goods, and paying taxes. These patriots are doing what every healthcare policy expert agrees we should all do – to go directly from being productive citizens to six feet under. For sudden death is free, and if everyone did this we wouldn’t have a healthcare crisis at all.

Furthermore, consider the kind of patient who receives ICDs. Some of these, of course (probably less than 10%) are young individuals with some sort of genetic propensity for sudden, lethal arrhythmias. But by far, most people who get ICDs are older folks, generally in their 60s, who have underlying cardiac disease. These are people who, if their sudden deaths are prevented, will go on consuming large amounts of Medicare dollars for the maintenance of their sundry significant medical conditions, who will go on collecting monthly Social Security payments, and who, when the end finally does come (possibly a decade or more into their ICD-extended life) will do so in the classic American manner – in an ICU, supported by incredibly expensive machines, drugs, and medical professionals. And thus, thanks to their ICDs, 75% of their lifetime healthcare expenditures will also be gobbled up during their last days.

Consider also that there is no constituency for “sudden death.” There is a constituency for breast cancer; a constituency for HIV-AIDS, a constituency for muscular dystrophy; a constituency for autism; and even a constituency for flatulence. But there is no constituency for sudden death. People who die suddenly (all 300,000 of them per year) generally have no idea that they are likely to become victims of arrhythmic death, and don’t care one way or the other if the means are available to prevent this unfortunate event. Until, perhaps, the last five seconds of their life, they are entirely unaware that sudden death is even a remote possibility.

So the path is open to demonize ICDs and those who build or implant them, and to hound them into curtailing – if not stopping entirely – their counterproductive activities.

While ICDs are indeed too expensive and too complex, the chief reason they are an abomination is that they prevent the very kind of death that every health policy expert understands is the ideal. And they convert that ideal death into a years-long orgy of entitlement-consumption, capped off by a typically American, very non-ideal, very expensive kind of death. Small wonder that ICDs are being specifically targeted by the Feds.

Because of what they do, and not because of their cost, the use of ICDs must be curtailed. ICDs would be targeted even if they were as simple, cheap and reliable as DrRich thinks they could and should be.

ICDs would be targeted even if they were FREE.

Heck, the very concept of an ICD is an abomination.

DrRich has expended a fair amount of effort explaining to his readers why it is so critically important for Obamacare (and for the Progressive program in general) to conduct a vigorous war against the obese. For the benefit of readers who may be new to DrRich’s thinking on this subject, please note the proper emphasis: This is not a war against obesity, but against the obese.

A central tenet of this war is the assertion (sometimes overt, sometimes tacit) that the obese are fat by choice, that is, as a matter of willfulness and recalcitrance. Their unsightly adiposity is a condition of their own choosing, a direct result of their having settled upon gluttony and sloth as central  life-principles. It is because of their self-indulgence that the obese have allowed themselves to become a threat to humanity, and most especially, a threat to the fiscal stability of our healthcare system and therefore our nation. They have, by their own volition, made themselves fair game for whatever actions our Central Authority may deem necessary to protect the legitimate interests of the collective against their corrosive corpulence.

When we who are thinner (and purer) go along with, and even encourage, official actions against the freedoms of fat people, we will have allowed an important precedent to become established. It will be a precedent under which our ever-wise leaders may legitimately restrict, control and tax virtually any human behavior they can claim may lead to an increased risk of healthcare expenditures.

DrRich’s hypothesis is that the real point of this war is to set this very precedent. And hence, the actual war is against the obese, and not obesity.

Any hypothesis, of course, is useful only if it helps to explain certain interesting phenomena that otherwise would be difficult to explain. And this hypothesis (as do all of DrRich’s hypotheses) does just that.

For instance, consider several recent decisions the U.S. Food and Drug Administration has made removing from the market, or preventing from entering the market, certain drugs aimed at treating obesity.

Pharmaceutical companies, in recent years, have steered hundreds of millions of dollars toward the development of drugs for the treatment of obesity. They made these investments in confident reliance on a particular premise, a premise that has been explicitly and passionately expressed in a thousand ways by physicians, government agencies, beloved public figures, the popular media, academics, public health experts, and (chances are) yo’ mama.

The Obesity Premise

This, of course, is the Obesity Premise. According to the Obesity Premise we are now engaged in a great war against obesity. Obesity, this premise holds, is perhaps the greatest threat to the health of our nation. Obesity imparts tremendous risk to the individual by causing vascular dysfunction, hypertension and insulin resistance, leading to heart attacks, strokes, peripheral vascular disease, aortic aneurysms, kidney failure, arthritis, depression, disability, and death.

It has been asserted that it would be better to receive a diagnosis of many types of cancer than it would to be obese. It has been asserted, in well-organized public service campaigns that allowing oneself to become obese is the equivalent of committing suicide (again, emphasizing the central tenet that obesity is voluntary). Because the scourge of obesity is such a grave threat to individuals and to our society, the Obesity Premise concludes, extraordinary measures are justified in fighting it.

Accordingly, our drug companies have invested many years and vast amounts of money (time and money they could have invested in banishing wrinkles, say, or creating fine and durable erections upon demand), to develop drugs for treating obesity. They have invested in this way completely assured that their efforts, if reasonably successful, would be richly rewarded in the marketplace. Thus has been the promise of the Obesity Premise.

But today, drug company executives, if they are at all astute, must surely agree with DrRich that the great premise upon which their massive efforts have relied is, in fact, not actually operational. Not even close.

Consider what has befallen drug companies just in recent weeks when they relied on the Obesity Premise:

Item 1. The August 14, 2010 issue of Lancet published the obituary for the once-sure-blockbuster anti-obesity drug rimonabant (Sanofi-Aventis). Through years and years of development efforts, and through several clinical trials, rimonabant looked very promising. It proved effective not only in producing significant weight loss, but also in significantly aiding in smoking cessation, and in improving blood lipids. It won marketing approval in Europe, and was on the verge of being approved by the FDA. But in the end, the FDA declined to approve the drug – and in 2008 the Europeans withdrew it from the market – because of strong “signals” seen in clinical trials, indicating an excess of significant depression and even suicide* among patients taking rimonabant. As a result, Sanofi-Aventis abandoned all further development efforts for rimonabant.

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* The relationship between obesity and suicide is surprising and intriguing, but has received relatively little public attention. Because this relationship could possibly be useful to the Progressives in their war against the obese, DrRich may soon write a post to help them along in their efforts.
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The recent Lancet article on rimonabant describes the results of the once-anxiously-awaited CRESCENDO study, a study designed to evaluate rimonabant’s effect on long-term mortality and morbidity. The study was ended prematurely (when rimonabant was withdrawn from the market), so only 14 months of follow-up were able to be reported. Out of over 9000 patients randomized to rimonabant, there were 4 suicides, as compared to 1 suicide in the 9000 patients receiving placebo. An accompanying editorial laments that investigators were compelled to stop the study early, since the potential cardiovascular benefit that might have been realized from the impressive reduction in risk factors among patients taking rimonabant, given another year or two of follow-up, might well have outweighed the small (and statistically non-significant) increase in suicides. The editoralists go on to observe, “However, any mortality associated with cardiovascular preventive therapy is generally viewed as unacceptable. The preventive approach is fundamentally different from curative therapy for a potentially lethal illness.”

Item 2. In October, 2010, the FDA withdrew the weight-loss drug sibutramine (Meridia, Abbott) from the market, when the post-marketing SCOUT study showed a 16% increase in serious cardiovascular events in patients taking the drug. The FDA advisory panel was split as to whether the drug should be withdrawn, but the FDA concluded that the drug was too unsafe to remain on the market. (It was originally approved in 1997.)

What most in the general media failed to report, however, was that the SCOUT study specifically enrolled patients who had preexisting cardiovascular disease, and for whom sibutramine had never been approved in the first place. In other words, it was a study designed to test whether the usage of the drug could be safely expanded to fat patients who already had heart disease. An appropriate conclusion, from the SCOUT data, would have been that usage of the drug should not be expanded to those patients. There was no apparent objective reason to take the drug away from obese patients who had no preexisting cardiac disease, and who had had access to the drug for 13 years.

Item 3. Also in October, the FDA rejected approval for the obesity drug lorcaserin (Arena Pharmaceuticals). They rejected the drug because preclinical studies showed a “signal” for an increase in breast tumors in rats.

Item 4. Again in October (truly a landmark month for anti-obesity drugs), the FDA rejected approval, for the second time, of the anti-obesity drug Qnexa (a combination of phentermine and topiramate, developed by Vivus). The drug was rated as moderately effective for weight loss, but was rejected because of concerns about cognitive disorders, metabolic problems, increased heart rate, and (most especially) birth defects.

While these are truly legitimate concerns, topiramate (the component to which most of the concerns with Qnexa are due) has been widely used for seizures, and especially for migraine headaches. While the FDA expressed special concern over the possibility of birth defects if topiramate were used in obese women of childbearing age, most migraine sufferers who take the drug are women of childbearing age.

What is the best explanation for these recent FDA decisions?

Please understand, Dear Reader, that DrRich is not necessarily saying that the FDA was flat-out wrong in rendering these decisions on any of these four anti-obesity drugs. All of these drugs posed at least the possibility of serious side effects in at least some patients, and none produced more than moderate average weight loss (though, to be sure, individual patients achieved remarkable results with each of these drugs).

Rather, DrRich is saying that the FDA’s decisions in each of these four cases were inconsistent with the Obestiy Premise, and therefore that the Obesity Premise is operationally false. That is, when it comes to actually taking action, the Central Authority entirely discounts the Obesity Premise.

The severely obese, in point of fact, do indeed have a remarkably elevated risk of developing premature, severe, disabling, expensive and lethal medical problems. Many of these individuals, in truth, would indeed be better off having many types of cancer. This aspect of the Obesity Premise is scientifically correct.*

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*There is much less evidence that people who are only moderately overweight – the vast majority of Americans said to be in grave danger due to their weight – are at markedly elevated risk because of weight alone. Indeed, DrRich has discussed evidence for the “Obesity Paradox,” whereby those who are moderately overweight appear to have improved survival compared to those of low or normal weight.
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So, at least for people who are very obese, a drug that produced weight loss but carried a small risk of potentially dangerous side effects might be justifiable, just as a treatment for cancer or heart disease might be justifiable despite a risk of serious side effects.  But this is clearly not how the authorities are treating weight loss drugs. It appears plain that in order for an obesity drug to be approved, that drug will have to display virtually no side effects. Operationally, therefore, obesity is treated as a low-risk medical condition whose treatment does not warrant any measurable risk. Indeed, obese patients are not to be allowed even the option of choosing such a drug, even after being fully informed of the potential risks and benefits.

If the Obesity Premise were operational, the authorities would have permitted studies with rimonabant – by far the most promising anti-obesity drug yet developed – to continue, in order to measure whether the long-term benefits of weight loss, smoking cessation, and lipid control outweighed what now appears to be a very small risk of excess suicide – a risk which could almost certainly be reduced even further with appropriate psychiatric screening.

If the Obesity Premise were operational, the authorities would not have withdrawn sibutramine from healthy obese patients (who had had access to the drug for over a decade) on the basis of a study which evaluated the drug in people with serious pre-existing cardiac conditions, and for whom the drug had never been approved.

If the Obesity Premise were operational, the authorities would not have banned lorcaserin for the sole reason of a tumor signal of uncertain significance seen in rats.

And if the Obesity Premise were operational, the authorities would not have denied topiramate to obese patients, when they allow the widespread use of the same drug in patients with migraines.

Undeniably, the actions of the Central Authority (as opposed to its words) entirely discount the Obesity Premise. Its actions reveal that the Obesity Premise is for public consumption – that is, for propaganda – only, and that its main purpose is to justify extraordinary measures.

The actions of the Central Authority do, on the other hand, comport with DrRich’s hypothesis – that we’re fighting a war against the obese, and not against obesity. In a war against the obese, a cure for obesity would preclude the need for strong central controls, and so would be counterproductive.

Therefore, while it goes about whipping our population into a frenzy about the scourge of obesity, the Central Authority is simultaneously doing whatever it can to stifle novel therapies that begin to attack obesity. True, none of these four drugs “cures” obesity, and none is risk-free. But the cure for any significant medical problem rarely occurs in a single step, or is accomplished without the possibility of side effects.

The Central Authority has sent a very clear message to the pharmaceutical industry: “When it comes to treating obesity, only perfection will be allowed; we insist on remarkable efficacy, and virtually no side effects. Without such a result all your efforts will come to nought.”

DrRich believes that in the last month the drug industry has heard this message loud and clear, and that it will be a very long time indeed before any more investments are made toward developing drugs to treat obesity.

By the same actions, the Central Authority has also sent a very clear message to the obese: “Do not expect any help from medical science, you self-indulgent, lazy, gluttonous budget-busters, you wreckers of society, you fattys. You did this to yourselves, by your own willful actions, and by your own actions have brought the rest of us to the brink. You deserve no more quarter than other sociopaths who undermine civil society – the bank robbers, the child snatchers, the Tea Party marchers. Because your individual choices have brought you to this juncture, prepare to be constrained in your individual choices.”

And so, in just the past few weeks, the war against the obese has seen significant victories, and has advanced ever closer to its ultimate goal.