The Four Ways To Reduce Healthcare Spending

DrRich | June 27th, 2011 - 6:06 am

Podcast:

 

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.

Healthcare Reform and End-of-Life Care

DrRich | June 20th, 2011 - 8:30 am

Death panels? We don’t need no stinkin’ death panels.

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

Can Advance Directives be Salvaged?

How To Sell Assisted Suicide

Ethicist-Assisted Suicide

On Killing the Elderly

Why People Think Obamacare Has Death Panels

When Is It OK Not To Follow The Guidelines?

DrRich | June 20th, 2011 - 7:21 am

Podcast:

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.

Cardiologists Are Still Missing COURAGE

DrRich | June 13th, 2011 - 7:21 am

Podcast:

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.

The Right To Bear Salt

DrRich | June 6th, 2011 - 5:02 am

Podcast:

 

 

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?