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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

How is the battle shaping up?

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

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

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

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

What about Method Four?

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

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

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

So, not to worry.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

These are those other kinds of guidelines.

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

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In 2007, when the results were published from the COURAGE trial, all the experts agreed that this study would fundamentally change the way cardiologists managed patients with stable coronary artery disease (CAD).*
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*”Stable” CAD simply means that a patient with CAD is not suffering from one of the acute coronary syndromes – ACS, an acute heart attack or unstable angina. At any given time, the large majority of patients with CAD are in a stable condition.
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But a new study tells us that hasn’t happened. The COURAGE trial has barely budged the way cardiologists treat patients with stable CAD.

Lots of people want to know why. As usual, DrRich is here to help.

The COURAGE trial compared the use of stents vs. drug therapy in patients with stable CAD. Over twenty-two hundred patients were randomized to receive either optimal drug therapy, or optimal drug therapy plus the insertion of stents. Patients were then followed for up to 7 years. Much to the surprise (and consternation) of the world’s cardiologists, there was no significant difference in the incidence of subsequent heart attack or death between the two groups. The addition of stents to optimal drug therapy made no difference in outcomes.

This, decidedly, was a result which was at variance with the Standard Operating Procedure of your average American cardiologist, whose scholarly analysis of the proper treatment of CAD has always distilled down to: “Blockage? Stent!”

But after spending some time trying unsuccessfully to explain away these results, even cardiologists finally had to admit that the COURAGE trial was legitimate, and that it was a game changer. (And to drive the point home, the results of COURAGE have since been reproduced in the BARI-2D trial.) Like it or not, drug therapy ought to be the default treatment for patients with stable CAD, and stents should be used only when drug therapy fails to adequately control symptoms.

When the COURAGE results were initially published they made a huge splash among not only cardiologists, but also the public in general. So cardiologists did not have the luxury of hiding behind (as doctors so often do when a study comes out the “wrong” way) the usual, relative obscurity of most clinical trials. Given the widespread publicity the study generated, it seemed inconceivable that the cardiology community could ignore these results and get away with it.

But a new study, published just last month in JAMA, reveals that ignore COURAGE they have.

In a registry-based survey that covered over 500,000 patients treated in over 1,000 hospitals, the new article reports that there has been little change in the use of drug therapy in patients with stable CAD since the COURAGE study was published. Prior to the publication of COURAGE, only 43.5% of patients who received stents had been tried on optimal drug therapy; two years after publication of COURAGE, that number had “increased” to 44.7%. And while the increase was statistically significant, observers have agreed that it is nonetheless trivial, and that the COURAGE trial apparently has made next to no impact on the practice patterns of cardiologists.

This revelation is proving embarrassing to even the usual spokespersons for the cardiology community, the luminaries who are always trotted out to explain the nuances of their colleagues’ sometimes odd behaviors, and to explain why those behaviors, actually, are not only reasonable but commendable. This time they are at a loss.

The best they can do, according to their commentary on TheHeart.org, is to offer two speculations: a) that, sometimes and for mysterious reasons, it can take several years for the results of important randomized trials to “disseminate” down to practicing physicians, and that apparently even the highly-sophisticated cardiology community is not immune to this phenomenon, and b) the cardiologists are waiting for their professional organizations to issue updated “guidelines” on stable CAD that take the COURAGE results into account. (The last official guidelines were published in 2002.)

Regarding this first explanation, DrRich can assure his readers that the results of the COURAGE trial were not slow to disseminate to American cardiologists. The results (and their implications) were, in fact, known immediately to every one – indeed, the buzz was palpable. It was, perhaps, the biggest news in the cardiology world in several years. If any cardiologists missed this seismic event, they are among that tiny, disconnected minority that is still out making house calls and distributing foxglove leaf, and likely would not know what a stent is, let alone be using them indiscriminately.

Regarding the “guidelines” excuse, DrRich is speechless. Since when are cardiologists guilty of following clinical guidelines to a fault?  If doctors, especially cardiologists, are already sticking strictly, in every particular, to sets of guidelines promulgated by committees of distant experts, even when they know those guidelines are out of date and, frankly, wrong, then (if you are an American patient) all is already lost.

DrRich does not buy either of these explanations. So what, then, is the real reason?

Is it greed? This is likely part of the explanation, and is all of the explanation for some cardiologists. (Self-interest plays as large a role in determining the actions of some practicing physicians as it does in determining the actions of those physicians whose reputations and hoped-for futures as “policy experts” requires them to denigrate the motives of practicing physicians every chance they get.) Indeed, DrRich would not be surprised to learn that some cardiologists of a certain age, realizing that the days of wine and roses are rapidly drawing to a close, are scrambling to insert every stent they can – and any other medical accoutrement they can justify deploying – as rapidly as possible, and then get the hell out.

But DrRich is certain that most cardiologists are genuinely trying to do what is best for their patients, and he believes that the failure to respond to the COURAGE trial is too generalized and too widespread to attribute entirely to greed.

Rather, DrRich believes that the results of the COURAGE trial simply fly in the face of your typical cardiologist’s world view. And while they undoubtedly understand those results intellectually, and even accept the results explicitly, they are simply having trouble incorporating those results into their conceptual framework for CAD. And since CAD is their livelihood, their philosophy, their sun, moon and stars, this amounts to an existential crisis.

When Galileo championed the Copernican view of the universe, and backed it up with sound scientific observations, he felt his views would receive approbation from the highest authority. After all, his old friend, the intellectual cleric Barberini (who had supported the publication of his book), was now Pope Urban VIII. But, while as Barberini his old friend could afford to be intellectually pure, as Pope Uban he could not. For Urban to accept Galileo’s work would formally call all Scripture into question, and seriously undermine the integrity and authority of the organization that had provided structure to western civilization for 1000 years. So Galileo had to suffer.

DrRich thinks that cardiologists find themselves in the position of Pope Urban – having the intellect to understand and accept certain surprising scientific results, but unable to put those results into practice without wrecking an entire way of life, and indeed, an entire way of looking at the world. They can either ignore (with, no doubt, some discomfort) the clear results of COURAGE, or abandon the world view that provides their sustenance and gives their lives meaning. That, DrRich thinks, is the real problem.

Regular readers will know that DrRich is not one to articulate a problem, and then simply walk away, leaving everyone to wonder what to do about it. So, as usual, DrRich has a suggestion.

The cure for the cardiologists’ existential problem is to articulate and accept a new world view, one that incorporates the results of COURAGE (and other clinical trial results that may seem puzzling under the old world view), and which places the proper usage of drugs and stents for CAD into a serviceable framework. While adopting this new world view will not be pain-free, it is one to which cardiologists can adapt – just as the Church eventually adapted to the heliocentric view of the cosmos.

And so, as a public service to his cardiology colleagues (and to their patients), DrRich will articulate a new world view on CAD. DrRich has not himself invented this new world view – most academic cardiologists, he believes, already endorse it, at least implicitly. But an explicit statement of the new world view – and an explicit rejection of the old – may help a few of DrRich’s cardiology friends to begin to accept the new “heliocentric” view of CAD, and thus to cure the existential crisis which (he postulates) is holding them back.

The Old World View

The old world view of CAD goes as follows: CAD produces localized plaques in the coronary arteries, which gradually grow out into the artery’s lumen, causing partial blockage of the artery. These “significant” plaques (generally regarded as plaques that are blocking 75 – 80% of the artery’s lumen) can produce angina (because during exertion not enough blood can get through the partial obstruction), and more importantly, can eventually cause ACS. The ACS occurs because the ballooning plaque can eventually rupture, causing a blood clot to form in the vessel, and producing sudden, high-grade occlusion of the artery.

Therefore, the cardiologist’s job is to identify these significant plaques and to stent them. Doing so will relieve “stable” angina, and will prevent ACS.

In the old world view, CAD is a localized process, that can be adequately treated with localized measures. If the location of the offending plaques can be identified (by cardiac catheterization) they can be treated. Heart attacks and death are thereby prevented.

The New World View

Whether or not CAD is producing a few localized “significant” plaques, the atherosclerosis that causes CAD is a generalized, and not a localized, process. That is, there are usually many plaques within the coronary arteries, most of which are not only “insignificant” (less than 75-80% blockages), but may even be nearly invisible during coronary angiography. Furthermore, it now appears that the majority of heart attacks (and other forms of ACS) occur when one of these “insignificant” plaques ruptures.

This is why it is not particularly unusual for somebody who has a “clean” coronary angiography to have a heart attack soon thereafter. And this is why aggressively treating stable but “significant” blockages with stents does not measurably reduce the incidence of heart attack and death.

CAD is a generalized, progressive disease. The treatment of CAD therefore inherently ought to be a medical (and not a localized, quasi-surgical) process. Ideally, one ought to use drugs that stabilize plaques and reduce the risk of rupture (statins, possibly beta blockers), along with drugs that reduce the propensity of blood to clot within the coronary artery, should a rupture occur (aspirin). And research should be aimed at identifying unstable plaques and finding better ways to stabilize them, and not at tweaking stents to render them marginally better than the prior ones.

A stent is fine to use on a significant blockage that is producing stable angina, but what it is accomplishing, one must realize, is merely to treat the symptom of angina – and not to prevent future heart attacks.

There.*

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* Under the new world view as well as the old, when ACS is actually occurring – when a plaque has ruptured and acute occlusion of an artery is taking place – inserting a stent often appears to be beneficial.
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Now that DrRich has entirely relieved the existential crisis all you cardiologists out there have been experiencing (you’re welcome!), all that remains is for somebody to address those few outliers among you who still haven’t heard about the COURAGE trial, or who are doggedly committed to following approved clinical guidelines under all circumstances, come hell or high water, even when they know them to be wrong, or who are just too consumed by greed to do the right thing.

While DrRich would consider it far from his method of choice for changing physicians’ behavior, and is in fact appalled by it, the Department of Justice’s new policy of conducting, Urban-like, inquisitions against physicians who are slow to adopt the Central Authority’s preferred practice patterns, and then criminally prosecuting those who are slow to comply, should work wonders in this regard.

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

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

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

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

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

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

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

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

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

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

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

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

1) Does Sodium Restriction Really Do Any Good?

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

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

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

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

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

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

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

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

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

2) Does Sodium Restriction Cause Harm?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I mean, why the heck not?

Podcast:

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.

Podcast:

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.

Podcast:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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DrRich’s Advance Directive:

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

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

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

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

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

The implantable cardioverter defibrillator (ICD), an incredible feat of visionary medical science blended with cutting edge engineering, a device responsible for saving thousands of lives a year, has gone from being a prototypical American success story to a symbol of healthcare excess. Today the ICD is widely castigated by the press, the public, the insurers, the government, and even most doctors as the poster child for expensive and wasteful medical technology. Consequently, the ICD and the doctors who implant them have become fair game for whatever the Central Authority wishes to throw at them. DrRich has explored this fascinating phenomenon in this series of articles;

How ICD Implantation Guidelines Are Being Abused

The DOJ Investigation of ICD Implanters, and What It Means

How the ICD Became an Abomination

Podcast:

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.

Podcast:

Two weeks ago DrRich wrote about the abuse of implantable defibrillator guidelines, as illustrated by a recent JAMA article claiming that over 22% of ICD (implantable cardioverter defibrillator) implantations are “non-evidence based.” The abuse of the guidelines, DrRich showed, was perpetrated less by ICD implanters, and more by the authors of that article. That fact being interesting but irrelevant, DrRich went on to speculate that perhaps the Feds would rouse themselves to take this issue to the next level.

It certainly did not take long. Indeed, just a days after DrRich’s post (which ought to completely absolve him of having any direct impact on the Feds’ action), it was revealed that the Department of Justice had already launched an investigation of ICD implants, as related to “proper guidelines for clinical decision making.”

This revelation was made on the website of the Heart Rhythm Society, the professional organization of electrophysiologists (EPs). HRS went on to say that it (HRS itself) had “agreed” to assist the DOJ in an advisory role in its investigation. Furthermore: “Because this is an ongoing investigation, HRS Staff or Leadership is not available for further comment. HRS will communicate additional information to its membership when permitted to do so by the DOJ.” (Emphasis DrRich’s.)

So here’s what we know:

1) The DOJ is actively investigating ICD implantations.
2) Their investigation has to do with the “proper use of guidelines” in selecting patients for ICDs.
3) HRS, the professional organization to which EPs pay huge dues each year in order that it might represent their interests, most especially their interests in Washington, has been preemptively co-opted by the Feds, and indeed has been gagged, so that any further communication to its own membership regarding the investigation is forbidden until further notice.

What will HRS tell the DOJ? It hardly matters, since the important thing has already been accomplished, i.e., effectively silencing the sole organization which represents the interests of EPs in Washington. But, while the HRS statement indicates that the organization is “assisting” the DOJ with “information that does not include either identifiable patient or facility level data,” and while DrRich has no doubt that this is the sincere intent of HRS, DrRich also believes it to be a sure thing that, at the end of the day, HRS (if it wishes immunity from any liability it might find itself subject to, regarding the advice, statements, educational materials, &c., it might have produced over the years, relating to clinical guidelines, or to any other matter of interest that might surface during the DOJ’s open-ended investigation), will tell the DOJ Anything It Wants To Know.

DrRich’s fellow bloggers who are also electrophysiolgists, Wes Fisher and John Mandrola, quickly noted the HRS statement on their respective blogs, and each expressed a certain amount of concern as to the implications of the DOJ’s investigation. But Larry Husten, who writes the excellent Cardiobrief blog, offers a calming voice: “I doubt that the DOJ is gearing up to tackle the vast majority of “reasonable” off-guideline implants. I think they will be going for the real outliers, and when and if they reveal the details of their case there will be little sympathy for their targets.”

Some of DrRich’s readers, who not inappropriately consider him to be a bit paranoid about the Central Authority, may find it surprising that, fundamentally, he agrees with Larry on this matter. He does not think the DOJ will round up large numbers (or even moderate numbers) of EPs who have been practicing basically sound electrophysiology, and who likely have reasonable explanations for any off-guideline ICD implantations they may have committed. DrRich agrees that the DOJ instead will go after a few outliers, figures who – very specifically – will garner little sympathy amongst the public, and indeed, who can be held out, with good effect, for public castigation. Preferably, these figures will be individuals about whom the marketing departments of one ICD manufacturer or another will have generated a few embarrassingly glowing e-mails, celebrating the sheer number of sales these doctors have produced, and discussing strategies – offering speaking engagements in exotic locations, putting on pig roasts, &c. – to keep the ball rolling.

In other words, it is likely at the end of the day the DOJ will produce a few doctors who are truly abusing the system, and harming patients to boot, and who will actually deserve what they will get.

There is no guarantee about this, of course. DrRich has written about how he himself, in his pristine innocence, was once the target of a federal investigation of ICD implants. And while he had on his side the virtues of good medical practice, truth, justice, the American Way, ethics, and even the law, and while he eventually was extricated from his situation with an entirely clean record, it was a close thing, and his escape was based more on luck than on being right. More recently, when DrRich had the “opportunity” to testify under oath in a DOJ investigation on another matter (which he is not yet at liberty to discuss, but regarding which, happily, he was only a witness this time, and not a target), DrRich was required by the DOJ to answer several questions about this very blog and its content, which (as far as DrRich could tell) had nothing whatsoever to do with the matter at hand. By this means DrRich was led to know that the Feds are either among his very great fans (Hi, Fellas!) – or something else.

DrRich’s paranoia, you see, is hard-won, not to mention evidence-based.

So it is indeed possible for innocents to get drawn into such matters – collateral damage is always unavoidable when one is at war – but odds are it won’t be You, or You, or You, so like Larry says, not to worry. They are looking for true evil-doers.

DrRich also agrees with Larry that this DOJ investigation is not a direct response to the JAMA article. The JAMA article appeared a mere week or two before HRS made its announcement – and its announcement obviously was so carefully lawyered-up that it must have taken weeks if not months to negotiate just that one detail with the DOJ. This has all been in the works for a while.  But DrRich does not believe for a moment that the DOJ was unaware that the JAMA article was coming out, or that its content, and the subsequent media attention it would create regarding the widespread ICD abuses being perpetrated by EPs, would dovetail nicely with the subsequent revelation by HRS of the DOJ investigation.

ICDs, and their implanters, have long been a target of the payers – both government payers and insurers – and this new enterprise is merely the latest battle in a long war.

As it happens, DrRich spoke at a certain investigators’ meeting just this past weekend, which was attended by a score or so of prominent electrophysiologists. He can report that the JAMA article (which defined off-guideline ICD usage as bad medicine and harmful to patients), followed by the intense publicity in the media this article generated (also emphasizing bad medicine and harm to patients), followed by the DOJ investigation related to the “proper use of guidelines” in ICD implantation, followed by the co-opting and the gagging of the EPs’ own professional organization, is having a delightfully chilling effect on the profession. DrRich thinks it is unlikely that very many off-guideline ICD implants will be performed for the foreseeable future, no matter how much individual patients might benefit from them, at least while this investigation continues. In fact, while the investigation is ongoing, DrRich suspects that even referrals to EPs for ICD implants will drop off. Because, until then, it will remain an open question just how rigorously one must stick to the letter of the guidelines in order for the DOJ to give one a pass, and to not be considered as guilty of crimes against humanity. The profession is duly intimidated.

Whatever the final outcome of this investigation, it has has already had its intended effect.  DrRich respectfully suggests that the DOJ might just as well take its time with it, and let the effect percolate to perfection.

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Note: Further evidence came this afternoon (January 24) that the effect the Central Authority had in mind is being realized, when Wells Fargo Securities downgraded St. Jude Medical from Outperform to Market Perform. The downgrade was based on WFS’ assessment that ICD implants will be reduced by 10% in 2011, thanks to the DOJ investigation. That reduction doesn’t quite do it, of course, but it’s a start.