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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

So open wide and say Moo.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Theory A:

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

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

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

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

Theory B:

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

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

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

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

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

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

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

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

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

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

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

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DrRich has long argued that a non-negotiable necessity of Obamacare will be to gain complete control over the behavior of American physicians. Most of the important medical decisions which doctors make – the ones that cost the government the most money – will be forcibly centralized. That is, panels of experts will determine which services are to be delivered to which patients under which circumstances, and doctors who fail to follow the experts’ dictates, in all their particulars, will be prosecuted as criminals.

This is more than just a matter of cost management. Placing control of most important decisions into the hands of sanctioned experts is a central tenet of the Progressive program. Centralizing decisionmaking – rather than leaving it in the hands of individuals, who will always operate for their own selfish benefit rather than for the benefit of the collective – is the principle mechanism by which the Progresive program (i.e., achieving the perfect society) is to be realized.

In recent years, growing numbers of doctors who recognize that their independence is quickly being taken away, and that the principle ethical precept of their profession (i.e., to always act for the benefit of their individual patient) is quickly being converted into a mortal sin, and that their own professional organizations are acquiescing with these changes, are realizing that the only way left open for them to retain some of their professional autonomy and professional integrity is to opt out of the system altogether, and begin contracting directly with their patients for medical services.

While the trend for doctors to opt out has not yet become widespread enough to have reached the consciousness of the broad public, it has certainly grabbed the attention of our Progressive leaders. For autonomous physicians pose the greatest possible threat to Obamacare, or to any Progressive healthcare system. And Progressives simply cannot abide these physicians who establish direct-pay practices.

So it has never been a question to DrRich whether our Progressive leaders will act to stop direct-pay medical practices. The only question has been how they will do it.

Over the past couple of months, DrRich has developed a theory about this. He hopes his theory is wrong, but he fears it is not.

DrRich believes that the medical profession is about to become nationalized, and doctors will become government employees, just like the airport security screeners. Furthermore, the mechanism by which they will become nationalized is the very same mechanism by which the airport security screeners were nationalized into the TSA, an event which occurred, DrRich reminds his readers, with barely a peep of protest from American conservatives, or anybody else. That is, it occurred precipitously, out of dire necessity, due to a grave national crisis that seemed to leave us little other choice.

DrRich believes the outline of the crisis that will justify the nationalization of the medical profession is becoming discernible. He believes the crisis will be precipitated by a provision of Obamacare that, for most observers, has just come to light.

On August 10 Medicare announced that, by March 23, 2013, most American physicians – at least 750,000 of them – will have to recertify their Medicare credentials. Now, for most Americans this prospect does not sound too odious. But be assured that it is.

The Medicare certification process is always a bureaucratic nightmare, and the nightmare will be greatly magnified when three-quarters of a million doctors are recertifying nearly at the same time.

All doctors have gone through Medicare certification at least once, and many have done it more than once. Because several common activities – such as changing your address – trigger the need to recertify with Medicare, doctors go through this process on an average of every decade or so. And most dread the experience.

Certifying requires filling out a 60-page form, a form which is absolutely masterful in combining obtuseness, opacity and redundancy, and then submitting it, along with all sorts of additional documentation, to one of several Medicare administrative contractors. These contractors are famous for their incompetence, their indifference, and their glacial bureaucratic pace. DrRich has experienced the ordeal himself, and knows countless doctors who have as well. The experience is nearly universally painful and expensive.

It is very common – possibly the rule – for submitted applications to be “lost,” at least once. (Officially, of course, the doctor never sent them in.) This event is so routine that doctors know to check with the contractor to confirm that their paperwork has been received. But the contractors have caught on to this gambit, and now refuse to reply to such queries for some specified period, usually for 30 days (at which time, it often turns out, the paperwork has disappeared into the ether). When the doctor finally gets to the point where the contractors will admit to having the documentation, there is another prolonged period of enforced silence, while the contractors painstakingly comb through the documents for misplaced commas, “X’s” typed over the line, or any other trivial excuse for discarding the application and notifying the physician (often, 2 or 3 months after originally submitting it), that they must begin the whole process again, and submit new forms. It is common for the entire process of recertification to take 3, 6 or even 12 months.

And the best part is, during the time the documentation is being reviewed, the physician cannot bill Medicare for any services. So during the recertification process the physician must either stop seeing Medicare patients, or continue seeing them without hope of payment. It is standard to lose at least a month – and very often more – of Medicare income during the recertification procedure.

These cost savings, of course, are why Medicare demands recertification every time you change your address, or add a partner, or sneeze. And this is why a slow, bureaucratic, demeaning recertification process is not only perfectly OK with the “system,” but is lovingly nurtured.

That, DrRich reminds you, is what happens during the typical recertification. The en masse recertification mandated by Obamacare, when 750,000 physicians will be going through this process at the same time, promises to become much, much worse. Doctors certainly believe it will be much worse.

“Tough luck for you doctors,” many loyal readers are now saying, “but what’s that got to do with the TSA-ification of American physicians?”

There are many thousands of PCPs today who are strongly considering opting out of Medicare, or who would like to opt out but they are afraid to take the chance. That is, they’re on the fence.  There are many thousands more who are hoping to retire within several years, and are hanging on almost on a year-by-year basis, waiting either to meet their target retirement funding, or until things get so bad that they just can’t do it any more.

DrRich thinks that a great many of these on-the-fence physicians will be tipped by the prospect of having to recertify for Medicare, especially under circumstances in which the process of recertification promises to be much worse than even the usual stomach-turning process.  If a doctor is thinking about getting out anyway, and now faces the prospect of losing (most likely) several months or possibly a year of Medicare income, then he or she is much more likely to just do it.

If this doesn’t do the trick, then add to it the fact that Medicare reimbursements to all providers are likely to be reduced by something like 25%, when the pre-deadlocked Congressional Super Committee* fails to agree on the necessary budget cuts later this year.  And last Thursday night, when the President announced that the Super Committee will have to find $2 trillion instead of only $1.5 trillion in budget cuts by Thanksgiving (in order to pay for his Jobs! Jobs! Jobs! bill), the likelihood that doctors will take a 25% cut in pay increased even more.

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*The Super Committee is pre-deadlocked because: a) the Republicans audaciously appointed at least one Tea Party supporter to the committee; b) the Democrat leadership (specifically, the Vice President) has identified the Tea Party as terrorists, a designation they have never been willing to assign to any other group, for instance, to Islamic extremists; and c) it is well known that one does not negotiate with terrorists.

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DrRich thinks the Progressives, whether by design or by blind luck, are now precipitating a crisis in healthcare. They are giving American doctors a huge incentive – probably two huge incentives – to opt out of Medicare all at once (instead of opting out gradually, as they are doing today).

If this occurs, the shortage of doctors who accept Medicare will become a hyper-acute problem. Panic will take hold.  The media will decry the crisis, running heart-rending stories about old people dying in their homes because they cannot get an appointment with a doctor, and blaming it all on the abiding greed of physicians (who, after all, probably still owe the government for their education, and hold their professional licences at the pleasure of the state). Medicare beneficiaries will flood their congresspersons’ offices with emails, letters, and their very bodies, demanding immediate action.

The autonomy of physicians may be OK in theory. Classic medical ethics might be a nice idea – a nice-to-have – if you can afford it. The doctors who “opted out” might actually be standing on principle, instead of on greed. But little matter. However you cut it we’ve got a real crisis here. The public’s right to healthcare is being violated. People are dying. The very security of the country is in jeopardy.

Not even conservatives will be able to withstand the tide of public opinion. Something will have to be done to compel doctors to provide that which they owe the public. In the war on illness, doctors need to be good soldiers. So like real soldiers, if they fail to volunteer for duty in sufficient numbers they will need to be drafted – and like soldiers they will need to work for, and receive their orders from, the government.

The politicians will be sorry about this. Nobody wanted it this way, they will say.  A little less greed, a little more compassion, and we could have avoided this. The doctors brought it on themselves, and have nobody to blame but themselves. The welfare of the public must take precedence.

Anyway, that’s DrRich’s theory. With luck, he is wrong. (Perhaps, for instance, many fewer physicians than DrRich thinks are on the fence about opting out.) But if he’s wrong, he’s more likely wrong about what, specifically, will precipitate the crisis that will finally justify taking away what remains of doctors’ autonomy, than he is about the general outline of what the end-game for American doctors will look like.

Progressivism often “progresses” toward its goal not gradually, but in major, discrete leaps – and it usually does so as the result of some “crisis” that causes the people to go along with changes they would never otherwise agree to. Which is why, if you’re a Progressive, a good crisis never goes to waste.

And the requisite “good crisis,” more often than one might think, turns out to be something you can goose along, just when you need it.

The “expert class” – the knowledgeable elites who are appointed by the Central Authority to establish the rules under which all of us in the great unwashed masses are to live our lives – will always (as a general proposition) tend to do great harm. Nowhere is this result more evident than in the policies promulgated in recent decades by the public health experts.

In each of the following three articles, DrRich deconstructs one of the major initiatives with which public health experts have assaulted the general public in recent years.  Each of these three initiatives was launched with great fanfare, displaying all the arrogant certainty exuded by any religious zealot, but sadly, was based on what to any objective observer was clearly insufficient data.  So the recent crusades against dietary fat, cholesterol, and salt each amounted to a great uncontrolled medical experiment, conducted on the entire population, in which each one of us was enrolled as an unsuspecting and involuntary research subject. The results of these massive experiments are just now coming to light.

Public health experts: stop them before they kill again!
Public Health Experts and The War Against Dietary Fat

Public Health Experts and The War Against Cholesterol

Public Health Experts and The War Against Salt

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

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

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

It was a cycle as natural as the seasons.

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

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

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

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

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

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

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

Hide the women and children!

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

You see how this works?

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

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

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

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

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

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.

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.

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.

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?

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.