Why Big Health Insurance Supported Obamacare, Part II

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 Why the Health Insurance Industry Supported Obamacare [14:52m]: Play Now | Play in Popup | Download (15)

The fact that the health insurance industry supported Obamacare from the very beginning was entirely missed by the mainstream press. This is perhaps understandable, since a) the mainstream press does not understand the dynamics of the healthcare system, and b) during the Obamacare drama, the health insurance companies had been assigned, and had graciously accepted, their vital role as the Forces of Evil. To the famously credulous members of the mainstream press, it was easy to imagine that the insurers were actually among the opposition.

But the insurance industry supported Obamacare from the start – and even before the start. During the Presidential race of 2008, for instance, managed care companies donated far more money to both Barack Obama and Hillary Clinton than to any Republican candidate, even though both of these Democratic candidates publicly castigated the insurance companies for producing most of the problems in American healthcare, and promised to institute reforms that would drastically cramp their style and reduce their profits.

Why would the insurance industry support the very candidates whose chief healthcare strategy was to demonize them? Quite simply, it was because the insurance industry had nowhere else to go.

By the time Mr. Obama became president, the once proud, self-confident, and even arrogant American health insurance industry had been completely humbled. Like the old Soviet Union twenty years earlier, it still may have looked formidable from the outside, but it was really an empty shell.  The industry had run out its string; it was entirely bereft of ideas. Its business model was completely broken, and it desperately needed an exit strategy. And it was due to the need to find a serviceable exit strategy that the industry supported Obamacare.

To understand what landed the insurance industry in this sad state of affairs, it is necessary to review its recent history.

The Rise of the For-Profit HMOs

When the Clintons set out to reform the American healthcare system in 1993, the health insurance industry initially claimed to support them. The Clintons had promised them a vast new market – the millions of heretofore uninsured Americans whose premiums would be paid, presumably, by the government.

But the alliance fell apart the moment the insurance industry began reading the massive tome of regulations the Clintons finally produced, and found in it much they didn’t like. Chiefly, they they didn’t like the parts that ceded full control of their industry to the government. So Big Health Insurance immediately turned against the Clintons, and spent millions of dollars introducing us to Harry and Louise (a “typical” American husband and wife who were viewed in numerous TV commercials discovering various appalling provisions of the Clinton plan). In the end, when the Clinton’s reform plan went down to ignominious defeat, the powerful health insurance industry, appropriately, got most of the credit.

Most of us Americans were happy at the time that the Clintons’ plan had been defeated, but during the debate over healthcare reform we had become convinced that the old way of doing healthcare wasn’t any good either. The healthcare system, we all knew by now, was bankrupting us.  And something needed to be done about it. But with the Clinton plan off the table, what were our options?

In the ashes of the Clintons’ failed effort, the health insurers saw their golden opportunity.  And they presented the American people with a savior. The savior was, of course, them.

The insurance industry made its pitch in a new guise which we Americans had never seen before. For the big fee-for-service insurance companies had transformed themselves into HMOs, and had fully assimilated the language of managed care. These were not the touchy-feely, non-profit HMOs that had been puttering around in the healthcare system for a decade or so.  These were meat-and-potatoes, for-profit HMOs, run for the most part by hard-nosed business executives, and newly formulated for a new era of American healthcare.

And here is what they said: “Citizens! We all – employers, patients, physicians, hospitals, manufacturers and insurers – have just dodged a bullet. Thanks to us, the frightening socialist reforms of the Clintons have been soundly defeated. But where does this leave us? We stand now between Scylla and Charybdis, between the specter of nationalized healthcare on one hand, and the continued profligacy of traditional fee-for-service medicine on the other. And we cannot countenance either. But here,” they continued, “is a third way. A painless way, based on the sound principles of managed care, open markets, and free enterprise. Let healthcare become a business like any other business, and the market forces will find ways not only to cut costs but also to improve quality, and with no government intervention.”

The offer, in other words, was to turn healthcare over to the business professionals now running the New Model HMOs, who were cocky with the certainty that they could harness the efficiencies of the marketplace to control costs, make a big profit at the same time, and be feted as saviors to boot. Because we’re Americans and we know the benefits of capitalism, and because the other choices we faced looked even worse, we all said, “Go for it.”

This change led to the most rapid transformation the American healthcare system has ever seen, and within a few short years, the majority of Americans were enrolled in HMOs, or some other species of corporate managed care.

So HMO executives set out to control the cost of American healthcare, and to make a spectacular profit doing it. And for a few years, they seemed successful. Healthcare inflation slowed dramatically in the late 1990s, and HMO profits soared.

But it was all an illusion.

The Fall of the For-Profit HMOs

The initial impressive profitability of New Model HMOs was due to the one-time reduction in cost you always get when you implement efficiencies of scale (made possible by merging enterprises), and by instituting the new standardization techniques favored by managed care theory. These steps reduced the cost of healthcare for a while, but the underlying rate of healthcare inflation (which is mostly caused by new medical technologies and an aging population, neither of which are cured by managed care) was pretty much unchanged. So by the early 2000s, when these one-time cost reductions had been fully realized, healthcare inflation was right back on the same unsustainable trajectory it had been on before.

Unfortunately for the HMOs, the big profits they enjoyed throughout the 1990s could not last. Their rapidly expanding valuations were attributable not to their efficient management of healthcare, but instead, to the frenzy of mergers that rapidly ensued, and to the acquisition and privatization of not-for-profit public assets for a tiny fraction of their true value.

So not long after the turn of the century the for-profit managed care companies were getting very nervous. For the very first time in their history, HMOs were faced with the prospect of having to earn their profits, profits sufficient to satisfy their shareholders, by actually managing the healthcare of sick people. This is something they had never accomplished before, and, by the time the election of 2008 approached, they knew they never would.

By that time they had tried everything. Beginning in 1994, filled with confidence and enthusiasm and cheered on (initially, at least) by the public and by public officials alike, the health insurance companies had more than 15 years of more-or-less unfettered freedom to institute any efficiencies it wanted to. In the ensuing years insurance companies tried all kinds of legitimate ideas for reducing healthcare costs, such as managed care, gatekeepers, clinical pathways, disease management programs, pay for performance, wellness programs, medical homes, and even a ruthless consolidation of the industry to achieve “efficiencies of scale.”

They also tried every sneaky and underhanded idea they could think of for reducing costs, like cherry-picking the healthy patients, treating chronically ill patients like pariahs so they would go away, making access to specialty care as inconvenient as possible, forcing doctors to sign “gag clauses” to prevent them from telling their patients about certain treatment options, browbeating primary care physicians into zombie-like compliance with handed-down care directives, refusing to cover expensive-but-effective medical services, and canceling the policies of tens of thousands of patients after they get sick, based on trumped-up technicalities. Indeed, they tried everything short of dispatching teams of Ninjas in the dark of night to slaughter their most expensive subscribers in their beds.  And finally, when all else failed, they instituted huge and unsustainable annual increases in premiums, to the point of driving their customers out of the market. (This latter move, of course, was an open acknowledgment that the industry had entered its death spiral.)

All these efforts were to little avail. The cost of healthcare continued to skyrocket, entirely unabated. And by 2009, when President Obama began his push for healthcare reform, the insurance companies knew they had no prospect of long-term profitability. Their business model was no longer viable, and, while telling soothing stories to avoid shareholder panic, they were urgently casting about for an exit strategy.

A drowning man will cling to any piece of flotsam that comes his way.  What the insurance industry found floating by was Obamacare.

What Health Insurers  Get From Obamacare

In return for its support in the healthcare reform battle, President Obama offered the insurance industry the graceful exit strategy it so desperately needed.  Under Obamacare, for at least a few years the insurers hope to get One Last Windfall – namely, profits from the influx of previously-uninsured Americans whose premiums will be paid – or at least subsidized – by taxpayers.  Here, the insurers are relying on the likelihood that the inflow of new premiums will, for a year or two at least, greatly outweigh the outflow of money they will have to spend caring for these new subscribers. Obviously, they will use every trick in their well-worn book to stave off expenditures for these new subscribers for as long as they can, but if they actually knew how to avoid paying healthcare costs indefinitely, they wouldn’t be seeking a government bail-out today. In any case, an inflow of new subscribers will be a very temporary source of profit for insurers. Hence, at best it is One Last Windfall.

What happens to the insurers after they exhaust this last windfall is still up in the air. Obamacare may, of course, eventually transition to a single-payer system, an outcome which many conservatives desperately fear, and many liberals fervently desire. In this case, there may very well be some final compensatory buy-out (or a buy-off) for the insurance companies. But more likely, the insurance companies under Obamacare will continue to exist essentially as public utilities. That is, they will exist as companies chartered by the government, which administer healthcare under the direction of the government, with the products they may offer, the prices they may charge, the profits they may keep, and the losses they may incur, determined solely by the government.  It’s not glorious, but it’s a living.

And it’s much better than where they would have ended up without Obamacare. Which is why they supported it from the start.

Now that we know why the insurance industry supported Obamacare, in the next post we will explore how the industry, at no small cost to its own public image, supported the President when it counted most.

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Why Big Health Insurance Supported Obamacare

Part I – Another Reason He Should Have Kept the Bust

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Now, read the whole story.

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

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 E&M Guidelines Undermine Patient Care, and That's The Point [14:43m]: Play Now | Play in Popup | Download (29)

Since the late 1990s, American physicians have labored under a set of tortuous documentation requirements imposed upon them by our government. The E&M guidelines (for “evaluation and management”), apply to the documentation that physicians are now obligated to provide in support of their Medicare billing. The E&M guidelines, first instituted in 1995 and revised in 1997, were part of the Clintons’ great fraud reduction initiative. Ostensibly, the strict documentation requirements reduce the opportunity for fraudulent billing.

While doctors initially railed against the E&M guidelines, they now suffer them in relative silence. The E&M guidelines have become, in fact, just one more hurdle which doctors must navigate as they pick their way through the vast obstacle course that now defines the practice of American medicine. Indeed, younger doctors accept the odious documentation requirements as a matter of course, knowing nothing better, just as children born into the direst third-world slums accept their abject poverty without notable complaint.

But occasionally, physicians of a certain age, dimly remembering how it ought to be, will still complain about these guidelines. One of these is revered fellow blogger DB, who (unlike DrRich) is still in the trenches, and must deal with – and try to teach trainees how to navigate through – this abomination on a daily basis. Accordingly, DB is periodically moved to remind us of what he graciously believes to be the unintended consequences resulting from the E&M guidelines, which is to say, DB seeks to remind us that current medical documentation requirements get in the way of good and efficient patient care.

For some, however, even this sort of mild-mannered, exceedingly polite objection is not to be countenanced. One of DB’s correspondents fired back at him:

“The templates are there to serve as a guide, not a hinderance. If you don’t like your “guide” then work to change it. You shouldn’t look at this “guide” as a form of billing, but rather as a guide in making sure you have covered your bases when seeing the patient. Proper documentation can lead to quality care and positive patient outcomes.”

This, indeed, is the official government position on E&M guidelines. It is so official, in fact, that it moves DrRich to wonder whether Cass Sunstein has actually implemented his well-documented anti-conspiracy strategy, and thus has dispatched armies of government-approved agents to monitor and actively counter “untruths” which are unfriendly to government aims, wherever they are found.

In any case, DrRich is not as polite (or as circumspect) as DB, and so he will say it outright.

The E&M guidelines were established for the specific purpose of controlling the behavior of physicians, to further the goals of covert rationing.

First and foremost, they create a Regulatory Speed Trap of the first order, so that with each and every patient encounter the item that will be foremost in the physician’s mind is not the needs of the patient, but in filling out the complex documentation in such a way as to avoid the appearance of committing a fraud. In practical terms, this means filling out the documentation so as to blend in with the masses, so that one’s records will be passed over by the sharp eyes of the greedy forensic accountants (who are paid by commission for detecting instances of substandard documentation, which are now construed as “fraud”), or even worse, by the sophisticated software now being deployed to detect ever-more nuanced gradations of “outliers.”

A classic post by The Happy Hospitalist describes the mysteries of E&M documentation better than any other attempt DrRich has seen. HH’s description of the documentation hoops through which physicians now must jump is detailed enough that it’s actually difficult to read. Which is the point.

Through their utter opacity and complexity, only partially reflected by the 48 pages of dense prose that comprise them, the E&M rules (for “rules” is what they are) in fact greatly magnify the doctor’s opportunity for making inadvertent documentation errors, and thus of producing a “fraudulent” bill. HH’s post nicely demonstrates how writing a progress note according to the E&M rules requires assembling a complicated set of “elements” from Column A and Column B, as from a Chinese menu, for each of four subject areas of the patient encounter – the history, the physical exam, the assessment, and the plan. Then somehow, one must translate the result (which reads like – and often is – a computer-generated form letter) into the proper, fully-supported billing code.

Even if this mess led to a straightforward means of determining proper billing codes (which it does not), it results in a medical progress note that is virtually undecipherable. This means that when another doctor (or even the same doctor on a different day) tries to read the progress notes to figure out what’s been going on with the patient (which used to be the point of medical progress notes, before they became primarily a vehicle for auditors), they cannot. Compliance with the E&M guidelines can thus actively confound patient care.

When the E&M guidelines were first introduced, they were recognized immediately by doctors as a complete abomination. Indeed, the great hue and cry from angry physicians (and the arrival on the scene of a new Republican administration) caused the Secretary of HHS to appoint a special commission to review the E&M guidelines in 2001. The commission concluded that indeed, the E&M guidelines were entirely counterproductive to patient care, and in June, 2002 voted (20-1) to recommend abandoning them altogether.

But HHS declined to follow the recommendations of its own commission, instead leaving the E&M guidelines in force “temporarily,” and vaguely promising to revise them “soon” in order to make them less dangerous to patient care – knowing full well that the saurian lassitude of the bureaucracy would easily outlast the fleeting indignation of the medical community.

(This simple example ought to teach us how difficult it will be to roll-back any of our new healthcare reforms in the future, even ones that are officially deemed to be harmful.)

Accordingly, not only has HHS failed to take (or, alternately, succeeded in not taking) steps to revise the E&M guidelines, they also have vigorously pressed forward with audits and prosecutions for the federal crime of healthcare fraud, based on physicians’ inadequate compliance with them. And, as the bureaucrats must have predicted, there has not been any substantial noise from doctors about revising these guidelines for several years now.

What’s more, there never will be. Save for the occasional exhortation from an old fossil (sorry, DB), the E&M guidelines have been fully absorbed into modern medical practice. They have become normal.

Accordingly, a multi-million dollar industry has sprung up to help physicians better comply with these coding guidelines. Physicians across the country are spending the time and money allotted for their continuing medical education learning to become better accountants, rather than better physicians.

Which brings DrRich to his last point: It is not actually possible to follow the E&M guidelines to anyone’s satisfaction.

There is, in fact, no “correct” way to code, because correct coding is impossible. This verity was proven a few years ago when a group of specialized government-sanctioned coders took a sample of typical doctor-patient visits, coded them according to their own E&M guidelines – and they all got different answers. (The results of this study were published in the Annals of Emergency Medicine in September, 2002.)

Obviously, then, since there is no “right” way to comply with the coding rules, any doctor toward whom the fickle finger of fate points the Feds is very likely to be found guilty of abuse, if not outright fraud. And what we’ve got here is a well-documented, openly acknowledged, peer-reviewed and published Regulatory Speed Trap.

Here’s what happens to doctors who are found to commit coding abuse (which is to say, to any doctors who are visited by Federally-sanctioned auditors):

1) A small sample of their patients’ charts is audited.
2) The error rate (with the auditor determining retrospectively what an error is) is calculated for that sample, then that rate is applied by extrapolation to all the Medicare billing the doctor has done for the past 6 years (the statute of limitations).
3) For each violation in coding the doctor is calculated to have committed during those six years, the doctor must pay a) triple the amount of restitution, and b) $11,000.00 (per coding violation).

It is not unusual for audited doctors to be hit with hundreds if not thousands of coding violations over a 6-year period, and the fines will almost always amount to well over 7 figures, if not 8. Even rich doctors usually can’t afford that kind of damage. However – if it’s just abuse the doctor has committed and not fraud – often the Feds may offer a settlement deal in the low 7 figures.

And here’s what happens if the coding violations are judged to be fraudulent (which, unfortunately, often appears a somewhat arbitrary designation):

1-3) All the above.
4) Jail

In summary, DB makes a very legitimate point, and has made this point several times over several years. Namely, the E&M coding rules are highly counterproductive to patient care. They produce medical records that are fundamentally undecipherable regarding actual medical content, even by medical professionals; and they distract physicians, with every patient encounter, into a fraud-avoidance exercise.

Sadly, however, DrRich does not believe that merely pointing out the harm being caused to thousands of patients each and every day by the E&M guidelines will do any good. Believing that it might do some good to call the Feds’ attention to it assumes that the harm is an unintended consequence, or at least, that it would be considered too high a price to pay.

This, DrRich feels obligated to reiterate, is demonstrably not the case. The Feds know that the E&M guidelines are harmful to patient care. Their own commission came to that very conclusion in 2002. The Feds know that failing to comply perfectly with the E&M guidelines in each and every case does not really indicate fraud and/or abuse, but is the necessary outcome when you institute a complex set of rules that not even the government’s own coders can interpret. Reminding the Feds of these facts, in public, may make them angry, but it will not change their position on E&M guidelines.

That the Feds continue to impose the E&M guidelines on physicians, despite the harm that they know this causes, tells us something very important about their underlying motives. When you are in the business of covertly rationing healthcare, controlling the physicians is Job One. And as George Orwell observed for us, when you want to control the behavior of some population, a critical step is to control the mode, the rules, and even the very language of communication.

That physicians continue to comply with such oppressions, despite the harm they know this causes, and (with notable exceptions) without serious complaint, tells us something important about them, too. DrRich would rather not say what that is.

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Now, read the whole story.

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

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 Dr. House and the Great American Experiment [15:11m]: Play Now | Play in Popup | Download (144)

DrRich’s Independence Day Address to his Loyal Readers:

DrRich has always found it fascinating that the television show, “House MD” has remained so popular for so long. After all, Gregory House embodies the polar opposite of what we all say we want in a modern physician. House may be brilliant, but he’s antisocial, arrogant, sloppy and rude. He holds his patients in contempt, and considers them to be mentally deficient, or prevaricators, or both. He will take any action he deems necessary, however illegal or immoral it may be, to make sure his patients get whatever medical interventions he has determined they need, whether they (or anyone else) likes it or not.

And when he does what he does, the individual autonomy of his patients never, ever enters his mind.

Given that House extravagantly violates his patients’ autonomy whenever he can find any excuse to do so, joyfully proclaiming his great contempt for them and their individual rights, then why is his story so popular in America and around the world?

DrRich believes that the answer to this question ought to remind us of the fundamentally precarious nature of individual autonomy within our healthcare system, and within our culture.

Individual Autonomy in Medicine

Maintaining the autonomy of the individual patient has become the primary principle of medical ethics. And medical paternalism, whereby the physician knows best and should rightly make the important medical decisions for his or her patient, is supposed to be a thing of the past.

It has been formally agreed, by medical ethicists all over the world, that patients have a nearly absolute right to determine their own medical destiny. In particular, unless the patient is incapacitated, the doctor (after taking every step necessary to inform the patient of all the available options, and the potential risks and benefits of each one) must defer to the final decision of the patient – even if the doctor strongly disagrees with that decision. Hence, the kind of behavior which is the modus operandi of Dr. House should be universally castigated.

The notion that the patient’s autonomy is and ought to be the predominant principle of medical ethics, of course, is entirely consistent with the Enlightenment ideal of individual rights. This ideal first developed in Europe nearly 500 years ago, but had trouble taking root there, and really only flowered when Europeans first came to America and had the opportunity to put it to work in an isolated location, where rigid social structures were not already in place. The development of this ideal culminated with America’s Declaration of Independence, in which our founders declared individual autonomy (life, liberty and the pursuit of happiness) to be an “inalienable” right granted by the Creator, and thus predating and taking precedence over any government created by mankind. And since that time the primacy of the individual in American culture has, more or less, remained our chief operating principle. Individual autonomy – or to put it in more familiar terms, individual freedom – is the foundational principle of our culture, and it is one that is perpetually worth fighting and dying to defend.

So the idea that the autonomy of the individual ought rightly to predominate when it comes to making medical decisions is simply a natural extension of the prime American ideal. It is obvious, most think, that this ought to be the governing principle of medical ethics.

Dr. House: The Champion of Beneficence

But unfortunately, it’s not that easy. There’s another principle of medical ethics that has an even longer history than that of autonomy – the principle of beneficence. Beneficence dictates that the physician must always act to maximize the benefit – and minimize the harm – to the patient. Beneficence recognizes that the physician is the holder of great and special knowledge that is not easily duplicated, and therefore has a special obligation to use that knowledge – always and without exception – to do what he knows is best for the patient. Dr. House is a proponent of the principle of beneficence (though he is most caustic and abrasive about expressing it). DrRich believes House is popular at least partly because the benefits that can accrue to a patient through the principle of beneficence – that is, through medical paternalism – are plain for all to see.

Obviously, as “House MD” nicely illustrates, the principles of beneficence and of individual autonomy will sometimes be in conflict.  When two worthwhile and legitimate ethical principles are found to be in conflict, that is called an ethical dilemma. Ethical dilemmas are often resolved either by consensus or by force. In our culture, this dilemma has been resolved (for now) by consensus. The world community has deemed individual autonomy to predominate over beneficence in making medical decisions.

DrRich’s point here is that Dr. House (the champion of beneficence) is not absolutely wrong. Indeed, he espouses a time-honored precept of medical ethics, which until quite recently was THE precept of medical ethics. There is much to be said for beneficence. Making the “right” medical decision often requires having deep and sophisticated knowledge about the options, knowledge which is often beyond the reach of many patients. And even sophisticated patients who are well and truly medically literate will often become lost when they are ill, distraught and afraid, and their capacity to make difficult decisions is diminished. Perhaps, some (like House) would say, their autonomy ought not be their chief concern at such times. Indeed, one could argue that in a perfect world, where the doctor has nearly perfect knowledge and a nearly perfect appreciation of what is best for the patient, beneficence should take precedence over autonomy.

Why Autonomy Predominates

In this light it is instructive to consider just how and why autonomy came to be declared, by universal consensus, the predominant principle of medical ethics. It happened after World War II, as a direct result of the Nuremberg Tribunal. During that Tribunal the trials against Nazi doctors revealed heinous behavior – generally involving medical “research” on Jewish prisoners – that exceeded all bounds of civilized activity. It became evident that under some circumstances (circumstances which were extreme under the Nazis, but which are by no means unique in human history) individual patients could not rely on the beneficence of society, or the beneficence of the government, or even the beneficence of their own doctors to protect them from abuse at the hands of authority. Thus, the ethical precept which asks patients ultimately to rely on the beneficence of others was starkly revealed to be wholly inadequate; and indeed, invites horrific results. Thus the precept of individual autonomy won out not because it is so inherently superior, but by default.

Subsequently, the Nuremberg Code of medical ethics was drafted and formally adopted worldwide. The Nuremberg Code officially declared individual autonomy to be the predominant precept of medical ethics, and the precept of beneficence, while also important, was declared to be of secondary concern. Where a conflict occurs between these two ethical precepts, the patient’s autonomy is to win out.

Again, this declaration was not a positive statement about how honoring the autonomy of the individual represents the peak of human ethical behavior. Rather, it was fundamentally a negative statement: Under duress (the Nuremberg Code admits) societies (and their agents) often behave very badly, and ultimately only the individual himself can be relied upon to at least attempt to protect his or her own best interests.

House vs. Autonomy and the Great American Experiment

DrRich will take this one step further: when our founders made individual autonomy the organizing principle of a new nation, they were also making a negative statement.

From their observation of human history (and anyone who doubts that our founders were intimately familiar with the great breadth of human history should re-read the Federalist Papers), they found that individuals could not rely on any earthly authority to protect them, their life and limb, or their individual prerogatives. Mankind had tried every variety of authority – kings, clergy, heroes, philosophers and professors – and individuals were eventually trampled under by them all. In the spirit of the Enlightenment, and because everything else had been tried many times and had failed, our founders declared individual liberty to be the bedrock of our new culture.

There is an inherent problem with relying on individual autonomy as the chief ethical principle of medicine, namely, autonomous patients not infrequently make very bad decisions for themselves, and then they – and their loved ones, and sometimes society – have to pay the consequences. The same occurs, of course, when we rely on individual autonomy as the chief operating principle of our civil life. The capacity of individuals to fend for themselves – to succeed in our competitive culture – is not equal, and so the outcomes are decidedly unequal. Autonomous individuals often fail – either because of inherent personal limitations, bad decisions, or bad luck.

So whether we’re talking about medicine or society at large, despite our foundational principles we will always have the temptation to return to a posture of dependence – of relying on the beneficence of some authority, in the hope of achieving more overall security or fairness – at the sacrifice of our individual autonomy.

In DrRich’s estimation the popularity of “House MD” is entirely consistent with this very strong tendency. Indeed, he thinks, the writers are compelled to make Dr. House as unattractive a person as he is, just to temper our enthusiasm for an authority figure who always knows what is best for us and acts on that knowledge, come hell or high water. If a figure such as Dr. House was also a compelling personality and had a gift with words, he would become almost Messianic – far too dangerous a prospect for a television program.

Those of us who defend the principle of individual autonomy – and the economic system of capitalism that flows from it – all too often forget where it came from, and DrRich believes this is why it can be so difficult to defend. We – and our founders – did not adopt it as the peak of all human thought, but for the very practical reason that ceding ultimate authority to any other entity, sooner or later, guarantees tyranny. This was true in 1776, and after observing the numerous experiments in socialism we have seen around the world since that time, is even more true today.

Individual autonomy will always be a very imperfect organizing principle, both for healthcare and for society at large. Making it an acceptable principle takes perpetual hard work, to find ways of smoothing out the stark inequities that will always result, without ceding too much corrupting power to some central authority. This is the Great American Experiment.

Those of us who have the privilege of being Americans today, of all days, find ourselves greatly challenged. But earlier generations of Americans faced challenges that were every bit as difficult. If we continually remind ourselves what’s at stake, and that while our system is not perfect or even perfectable, it remains far better than any other system that has ever been tried, and that we can continue to improve on it without ceding our destiny – medical or civil – to a corruptible central authority, then perhaps we can keep that Great American Experiment going, and eventually hand it off intact to yet another generation, to face yet another generation’s challenges.

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Now, read the whole story.

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

Now on Kindle!

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 Physician-Industry Relationships – What Is Appropriate? [21:13m]: Play Now | Play in Popup | Download (185)

The following is a close approximation of a talk DrRich gave to a gathering of some of the world’s most promising young cardiac electrophysiologists, in Nice, France, on June 15, 2010. He was asked to talk to these young physicians about physician-industry relationships. The organizers of this gathering apparently did not know, as anyone who reads this blog would know, that DrRich should never, ever be allowed an opportunity to influence promising young physicians.  But, what’s done is done.

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A worldwide controversy is now roiling over the appropriate relationship between physicians and industry. Superficially at least, this controversy has to do with the undisputed fact that a physician’s relationship with industry can unduly influence his or her behavior.

That is, this controversy is said to be related to the conflicts of interest (COI) that are always inherent, to some degree, in such relationships.

I believe there is a deeper, and far more disturbing, reason behind this controversy, and I will address it in a short while.  But let’s first talk about COI, because it is ostensibly the chief concern, and it is in fact a very important issue.

A COI is present when an individual has a sacred, fiduciary duty (i.e., a duty of trust) to Entity A, but then develops a secondary relationship with Entity B, which (by creating self-interest, competing loyalties, or even just an inability to be objective), threatens to interfere with the primary duty to Entity A.

Physicians, especially academic physicians, have (at various times) at least three primary fiduciary duties that must take priority. These are: a duty to patients when practicing medicine; a duty to students (i.e., actual students, colleagues, or the public) when teaching; and a duty to society (and truth itself) when conducting medical research.  It is clear that ties with specific companies and their products can easily create important COI that may interfere with each of these primary fiduciary duties, and it is equally clear that physicians have commonly allowed this interference to happen.

Far more often than we like to imagine, doctors have allowed bias to creep in when recommending a course of action for their patients, in imparting knowledge to trainees, colleagues or the public, or when designing, analyzing or reporting results of clinical trials. And typically, most doctors who exercise inappropriate bias have convinced themselves that they are really acting in the best interests of their patients, students or society at large. For it is quite difficult to be objective about one’s own COI.

And there is no question that industry has become adept at the gentle art of creating COI among physicians (subliminally whenever possible), and have carefully incorporated the creation of such conflicts into their business models.

Obvious abuses we have all seen include doctors “shilling” for companies or their products at national meetings; clinical guidelines committees seeded with biased members; unbelievable amounts of money (well above “fair market value) being paid to key doctors for consulting services; long advertisements disguised as CME events; and ghost-writing scientific papers, then recruiting prominent physicians to sign on as “authors” after the fact. There are many others.

Such ongoing abuses of our fiduciary duties ought to be deeply embarrassing to us in the medical profession.

And if it’s not embarrassing, it is at least becoming painful. In the US, physicians who are discovered doing some of these things are being called out publicly, being investigated by Congress if not the Justice Department, losing their prestigious academic positions, and having their reputations destroyed. It is hard to be sympathetic toward them.

Despite all the negative attention – both public and legal – that such COI have brought to our profession in recent years, many of us continue to have tin ears.  A recent example, which has caused a stir in the blogosphere if nowhere else, happens to relate to the EP community. (Thanks to Larry Huston of Cardiobrief who did the heavy lifting on this one. )

Recently, the ACC/HRS collaborated in the launch of a new website, called AFibProfessional.org, which is described as “a unique collaboration to address atrial fibrillation for the cardiology community.” The site has only one corporate sponsor – Sanofi, the maker of Multaq.

At the time of launch, all the content on this new website consisted merely of old, recycled material from older ACC and HRS websites, with a single exception. The single exception was a slide lecture by a prominent electrophysiologist, who we all know and love, on “Managing Atrial Fibrillation.”  This lecture makes a strong case for the off-label, off-guideline use of Multaq. The lecture was posted without any COI disclosure statements, though the lecturer, it turns out, has significant financial ties to Sanofi.  When the matter became a public issue, the lecture was pulled from the site, and the ACC promised to investigate. A few days later, the investigation apparently completed to the ACC’s satisfaction, the lecture was reposted, this time with a COI disclosure.

While one hesitates to suggest malfeasance here, it certainly looks bad.  For the ACC and HRS to co-sponsor a brand new website that , by all appearances, is chiefly a vehicle for advertising Multaq suggests, if nothing else, that we in the medical profession, and our professional organizations, still don’t get it. If we don’t police our own COI, it will be policed for us.

What remedy should be applied?  A reasonable approach would be to recognize that physician-industry ties will always bring at least some COI, and to manage the problem by strictly limiting inappropriate COI, and fully disclosing any that remain.

Accordingly, a number of groups – most prominently the Institute Of Medicine – have recently made formal, and tough, recommendations regarding physician-industry relationships. The final “rules” under which we will all have to live are still being negotiated.

But it is highly likely that they will include many if not all of the following:

-    Doctors should not accept any gifts, no matter how small, from industry. These include trivialities such as pens and notepads, and more substantial gifts such as meals and travel.
-    Doctors should not give presentations in which content is controlled or influenced by industry.
-    Doctors should not consult for industry without a written contract, nor should they receive more than “fair market value” for consulting activities.
-    Doctors should not accept drug samples from industry.
-    Doctors who have a financial interest in a product or company should not participate in clinical trials in any capacity that involve that product or company, including patient enrollment, data collection, analysis or reporting.
-    Doctors who have industry ties should not participate in the development of clinical guidelines.
-    Medical schools and professional organizations should not accept direct funding, or attributable funding, for CME.
-    Any interaction with industry will be fully disclosed, and made publicly available.

What this “full disclosure” will look like can be seen in the Physician Payment Sunshine Act, a law which is pending in the US. Under this act,  all “transfers of value” totaling $100 or more in a year to any physician will be reported by each company to the government annually, along with each physician’s identifying information. Such “TOV” includes food, trinkets, entertainment or gifts; travel; consulting fees or honoraria; funding for research or education; stocks or stock options; ownership or investment interest, and any other economic benefit.  This information will be posted on a public, searchable government website. Companies will be fined $10,000 for each incident of an unreported TOV.

You younger physicians will be spending your careers in a COI environment that is significantly different from that which we, your elders, have experienced. Activities that have been acceptable, and even encouraged, will now cause you to be publicly stigmatized, or worse. This matter is in great flux, and you need to pay close attention to it as the rules are changing. In the meantime, you need to choose your interactions with industry very carefully, and very circumspectly.

Everything I have just discussed assumes that the real issue regarding doctor-industry relationships is COI. Indeed, everything I have discussed assumes a particular way of looking at industry relationships, which I will call Theory A. Theory A, goes as follows:

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 COI, which we must manage by strictly limiting their extent, and fully disclosing the ones that are left.

On the surface, at least, that’s what the debate is about – where to draw the necessary limits.  But just below the surface, the debate is about something else entirely. Beneath the surface, Theory A is rejected outright.

Today we hear prominent voices telling us that merely managing COI does not go far enough. No amount of COI is acceptable, and ALL physician-industry ties should be prohibited.  Among these is Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of COI is not to have them at all.” For these voices, Theory A simply does not apply. Rather, (I submit) 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.

A corollary of Theory B is that it can only be the State’s job to cripple these alliances.

Proponents of Theory B, noting, not incorrectly, that medical industry is chiefly concerned with profits rather than the public good, conclude that 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. 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. Most of them 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 gets to use industry’s products, or when and how.

That kind of information can only be managed by unbiased sources. Proponents of Theory B invariably refer to government-appointed panels of experts to determine which products of industry are good and bad, and to 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.

Inherent in this viewpoint is the notion that the State is an honest broker, with no bias of its own, except to do what is best for the population. The State, in its disinterested beneficence, is the only civil entity which can pass judgment on which medical information is suitable for general consumption.

But even as a general proposition, no government is an unbiased and honest broker. Politics, according to Harold Lasswell, an early Progressive political scientist, is determining who gets what, when and how. Government officials do not cancel their own human nature when they put on a government name tag. As they go about the business of determining who gets what, when and how, they inevitably – and most often intentionally – create various favored constituencies, fiefdoms, and clienteles to suit their own goal. That goal is to consolidate and expand their own authority. In this way, in the exercise of its political mandate the government always creates co-dependencies, and determines winners and losers. So even in the general case, the government cannot be an honest broker.

But with regard to healthcare, government bias goes far beyond the general case. Healthcare spending is the chief problem governments face today. In the US, projected Medicare expenditures over the next 30 – 40 years will be $35-55 trillion. Numbers like this are deeply destabilizing, and simply cannot be abided, and promise nothing but chaos, revolution, and societal disintegration.

To the State, controlling healthcare spending is an existential problem, a matter of life and death, an issue that justifies any solution that has even a slight chance of working.

Why is the cost of healthcare rising so rapidly? Fundamentally, it is medical progress. Medical progress has greatly increased overall healthcare expenditures. Simply consider, for instance, the many fatal illnesses we have converted to chronic, and chronically expensive diseases – coronary artery disease, kidney disease, HIV/AIDS, various forms of cancer, and heart failure, to name a few.  Medical progress has made great strides in early detection and prevention, and preventive medicine always increases the cost of care.  And thanks at least partly to medical progress, life expectancies are on the rise, and people have many more years to consume healthcare.

Medical progress is very expensive, and the more we have of it the more it costs. The State can only look at medical progress and say, “Medical progress is killing us.”

But it is not politically feasible to come right out and say that stifling medical progress is necessary to the survival of the State. Rather, the State must assert that what it is stifling is greed.

Hillary Clinton gave us the State’s operative formulation in 1993: “There are just too many greedy doctors using too much expensive technology.”  So, to control costs, the State must control the doctors; and the State must control the technology, which is to say, industry.

I submit that an underlying theme within the debate over doctor-industry relationships is a desire to greatly slow or even stop the real threat to the State: medical progress, and the vast expenditures which medical progress produces.

The State has several means for stifling medical progress.  The State can institute increasingly oppressive regulations, which can have the effect of hamstringing industry, but more importantly, has the effect of converting industry to a client of the State, dependent on the State’s favors for its success. The State can demonize industry, trying to convince the public that drug companies and medical device companies are evil entities that would just as soon harm them as help them, and indeed, without the strong hand of the State would prefer to distribute pain and suffering as the more favored pathway to windfall profits. But more to the point of today’s discussion, the State can stifle the doctor-industry relationships that are so critical in steering medical progress in a clinically relevant direction.

So the  interests of industry must be represented as being fundamentally counter to the interests of society, and the doctors who have relationships with industry must be painted as their evil (or, at best, deluded) minions.

Yes, industry is biased, and industry will act on that bias whenever they can get away with it. Industry just can’t help itself. That’s just the way it is.

But the State is also biased. And the State will also act on that bias whenever they can get away with it. The State can’t help itself. That’s just the way it is.

Industry will try to exercise its influence over us by data-driven persuasion, and when that fails they will try to sweeten the persuasion, perhaps even with subtle or not-so-subtle bribes.

But the exercise of persuasion is even more dangerous when done by the State. While the State may also try to influence us with data-driven persuasion, it is very quick to resort instead to propaganda (i.e., the art of information-control by which the unwashed masses are told only what the specialized classes have determined is best for them), and when that fails, the State will resort to its ultimate form of persuasion – the enforcement of new and suppressive regulations at the point of a gun.

So, while industry is indeed biased, and needs to be kept at arms length, de-legitimizing industry altogether would be disastrous.  It would create an open field for extraordinarily powerful forces which are at least as biased, but in the opposite direction. If we value medical progress, we need the balance that industry provides – and that includes not only industry’s products, but its voice.

Medical progress driven by industry-physician collaboration is good for mankind. But that collaboration inevitably creates conflicts. We physicians need to control those conflicts, or the collaboration will be forcibly terminated altogether. Our professional history to date is bleak in this regard, and we only have one chance left to get it right, if that.

But in controlling our COI, we should not allow ourselves to be pushed too far. We should agree to reasonable limits on conflicts, and on full disclosure of any conflicts that remain. But we should draw the line when we are urged to forgo all relationships with industry altogether. We must recognize that industry and its selfish goals provide a necessary counterbalance to even more powerful forces whose goal is to stifle medical progress.

I don’t ask that you accept my synthesis of this problem at face value. I simply ask that you listen to what I am suggesting, and observe for yourself what is happening out in the wild. Then challenge yourself to come up with a better explanation for what you see happening out there. I sincerely hope you can, as I would much rather that my conclusions were not true. So if you do come up with a better explanation, I will greatly appreciate hearing about it.

________________________________

Now, read the whole story.

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

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 Even Dermatologists Have Skin In This Game [15:44m]: Play Now | Play in Popup | Download (176)

Recently, DrRich wrote a series of posts detailing how the American healthcare system – even before the new reforms kick in – is taking steps to prevent individual citizens from being allowed to spend their own money on their own healthcare. Part of that effort, of course, is to restrict physicians from offering direct-pay medical services to their patients.

DrRich may have given the impression that only primary care doctors are affected by efforts to restrict their practices in this way. If so, he apologizes.

He particularly owes an apology to his friends the dermatologists. Indeed, DrRich has been reminded of an article that appeared in the New York Times a while back, which castigated dermatologists for the sin of establishing direct-pay practices, and in particular, for creating their own brand of a two-tiered healthcare system – one for patients with skin disorders, and one for “cosmetic dermatology.”

As the Times describes it, patients who wish to see a dermatologist for, say, possible skin cancer are put on a waiting list, and when their appointed time finally arrives (generally several months later) they are subjected to modern medical hell. To wit: Upon arriving in a lackluster office, the patient is shelved for a while in an unattractive, poorly lit waiting room equipped with a broken TV, fuzz balls on the floor, old magazines, the unruly children of other patients, and surly office personnel. Eventually the now-even-more-disheartened patient’s name is called by an indifferent nurse practitioner, who, operating from a checklist of questions, will “triage” her to the appropriate patient-category (e.g., acne, fungus, cancer, warts- you know, dermatology stuff), then have her strip in order to fully expose the large organ (i.e., the skin) for which she has sought assistance, hand her a scratchy yellow paper gown to cover her nakedness, and have her wait for some time in a chilly exam room to see His Holiness, the actual doctor. At last the dermatologist arrives, mutters a greeting (or some other ritual uttering), glances at a clipboard, and announces, “Show me your [acne, fungus, cancer, warts];” whereupon, having regarded the cause of cutaneous concern, and having made a professional determination, he either signs the prescription that has been pre-written for him by the nurse practitioner, or schedules a procedure. Then, placing her bundle of clothing into her arms and wishing her a good day, the doctor shoves her out into the hall to finish dressing, as the formal interview is completed, and the exam room is at a premium.

Presumably, one hopes, some dermatology practices not visited by the New York Times might not be quite so bad. Still, anyone who’s been seen by an American PCP lately will nod sympathetically at the dermatology patient’s ordeal.

Now observe what the Times observes when the patient, instead of having an actual skin problem, merely is sagging here and there and wishes to be shorn up. That is, the patient has a cosmetic issue. That is, the patient wants Botox.

The same dermatologist will often have an entirely different setup for these patients. This time the patient is seen immediately, possibly the same day, as dermatologists are sensitive to the needs of their clients who have an impending public engagement, and thus need to look their best. If this patient is to wait at all, she will wait in a modern, tastefully decorated private room. She will then be seen not by a mere nurse practitioner but by an aesthetician, who will do a careful assessment of the sagging parts, and, aside from suggesting more injection sites than the patient might originally have had in mind, will offer a complete program for long-term cosmetic maintenance, which naturally will include quarterly Botoxification. At just the proper moment the dermatologist comes in, greets the patient warmly and reassuringly; then reviews the recommendations of the aesthetician and discusses those recommendations at length with both the aesthetician and the patient, studying the patient’s face in depth as he does so, pointing, nodding, studying, adjusting, all the while smiling confidently. Yes, he indicates, we will all be very happy indeed with the results. Finally the doctor begins to make the now-thoroughly-discussed-and-agreed-upon injections, doing so with the greatest solicitude and sensitivity. The patient is then given as much time as she needs to collect herself, and is invited to “recover” in a room set aside for this purpose, with flattering lighting, soft music, a cappuccino machine, and perhaps a glass of wine. She leaves the office a new person. And, just as the dermatologist has promised, all are indeed very happy with the outcome.

Naturally, the New York Times is scandalized by the dichotomy which its discerning readers will note here. Why should a patient with a mere cosmetic issue be treated so well, when a patient with an actual medical problem, possibly even skin cancer, is treated so shabbily? How can dermatologists openly encourage such a two-tiered system?

DrRich has a word of advice for the scandalized reporters of the New York Times, and any other concerned Americans who are worried that dermatologists, by setting up separate-but-not-equal practices for their two kinds of patients, are moving us one step closer to the dreaded two-tiered healthcare system we all abhor. That word is: Chill.

Allow DrRich to support this friendly recommendation with two observations.

1) We already have a multi-tiered healthcare system, and little or none of it is the fault of dermatologists. It is the fault of human nature. All countries have at least a two-tiered healthcare system, including countries (like Cuba and China) that have specifically embraced egalitarianism (rather than individual autonomy) as the fundamental operating principle. A second tier is necessary if for no other reason than political leaders and other individuals critically important to the collective effort must have somewhere to go for their healthcare.  The second tier, like the poor, will always be with us.

2) When a dermatologist spends Tuesday afternoon in her run-down office, treating people who come to her for bona fide skin disorders like they’re not really patients but widgets on an assembly line, then spends Wednesday in her other, much more amenable offices, treating the merely cosmetically-challenged like they are minor nobility, she is not really engaging in two-tiered healthcare. Not at all. Instead, on Tuesday she is practicing real, true, prescribed-by-society, by-the-book American healthcare, just as our leaders (in their wisdom) have carefully set it up for us, and on Wednesday she is doing Something Altogether Different.

Injecting Botox is officially and formally not part of American healthcare. How do we know this? Because it is not covered by Medicare or health insurance. If you want Botox you’ve got to pay for it your own self, just as you do if you want a TV or a car. So by all that is sacred, injecting Botox is NOT American healthcare.

Furthermore, when one looks at it objectively, injecting Botox is not even really practicing medicine, at least not in any true sense. In actual truth, it takes very little training or expertise to inject Botox. There’s no reason one must go to college, graduate from medical school, or do several additional years of training in dermatology (or any other specialty) to do this. Anyone with a needle and syringe, an alcohol wipe, and access to Botox could do as well. Just find the wrinkle and stick it. If they made the materials available over-the-counter, most folks would do just fine with it.

The sheer arbitrariness by which injecting Botox is deemed by the authorities to constitute the practice of medicine can also be illustrated by considering a somewhat different, equally well-known cosmetic procedure, one that also involves injecting substances through the skin via needles, and that has much more to do with the actual skin itself than Botox injections (which do not really affect the skin itself, but only the muscles under the skin). DrRich speaks, obviously, of the tattoo. But unlike making Botox injections, tattooing requires real skill, knowledge, training, expertise and artistic talent. Most dermatologists simply could not manage a highly technical skill like that.  The point being, of course, that if you were to describe Botox injections and tattooing to a visitor from Mars, then ask him/her/it which of these two dermatological procedures ought to require a medical license and board certification, the Martian would get it wrong every time.

DrRich understands, of course, that while administering Botox is, in practical and objective terms, no more practicing medicine than is applying an ice-pack to a bruised knee, legally it is indeed deemed to be the practice of medicine. Accordingly, doctors in general (and dermatologists in particular), relying on this nonsensical designation, have legally cornered the market on Botox injections. So it’s not like you could just set up a booth at the Mall and hire high school students to do this (as you can for, say, ear-piercing – which, in contrast to Botox injections, is an actual surgical procedure which is intended to result in a permanent structural change in a body part). If you set up a chain of Botox Booths, you would be practicing medicine without a license, which is a serious crime.

But fundamentally, while performing Botox injections may have a certain legal status, in any true sense it is not really practicing medicine.  Not when ear-piercing and tattooing are not. Rather, in real life, injecting Botox is simply an activity some dermatologists may choose to do when they’re not doing real dermatology.

To say it another way, when the dermatologist goes to her “other office” to cater to a self-paying variety of clientele, she is practicing medicine only from the most arbitrary and strictly legalistic viewpoint. In real life, she is doing Something Else. She is engaging in a Pastime.

Doctors, of course, often have Pastimes. That is, they partake in activities other than practicing medicine when they could, in fact, be seeing more patients. Some have taken up golf. Others have started side businesses such as restaurants or software companies. Some do charity work, or go to graduate school for an MBA. Still others have opted to work part time in order to raise their families.

Society generally finds such activities acceptable, and – to this point – does not insist that all doctors forgo all other human endeavors in order to see as many patients as humanly possible, during all their waking hours. While society seems to be moving closer to declaring that doctors owe this duty to the collective, it has not reached this point quite yet.

Until society sees fit to legislate otherwise (which, DrRich supposes, could happen really very soon now), doctors will continue to spend some of their time engaging in hobbies and business or family activities outside of the formal healthcare system. Some may even leave the formal healthcare system altogether in favor of these other activities. DrRich himself has done this. And until society renders it officially illegal for doctors to do so, DrRich respectfully asks that doctors be left alone to celebrate their individual autonomy as granted to them under America’s founding documents, whether it’s by establishing authentic Indian restaurants, setting up Botox clinics, or even becoming direct-pay practitioners.

One last word of advice for DrRich’s dermatology friends: Have fun with your Botox clinics for now, fellas and ladies, but please don’t become too invested in them.  This is definitely a shallow-moat line of business, and the only thing that gives you any protection at all is your aura as highly trained specialists, with special and secret knowledge about an organ (i.e., the skin) which visibly droops when the underlying muscles become lax with age and gravity. A single action by forces entirely out of your control – say, Congress or the FDA – could render your monopoly entirely moot overnight, and you will be instantly priced out of business by hordes of PCPs, nurse practitioners, Botox booths in Walmart, and even home Botox injection kits. So please remember to at least keep your hand in genuine dermatology, or get your MBA, or perfect your long iron shots, or even learn a real skill, like tattooing – but do something that will provide you with a Plan C. Because Plan Botox is definitely a high risk endeavor over the long term.

________________________________

Now, read the whole story.

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

Now on Kindle!

Podcast:

 

 Neuroscientists Beware! Here Come the Cardiologists! [17:31m]: Play Now | Play in Popup | Download (108)

Throughout the millennia, the characteristic that has distinguished robust barbarians from extinct ones is that, when forces beyond their control begin encroaching on their turf, they simply pick up and encroach on the turf of less aggressive people (generally, of people who are more advanced, both intellectually and culturally, than they are).

And so, when the Feds begin making noises about limiting some of cardiology’s favorite revenue-generating activities, the cardiologists – among the most robust of the medical barbarians – are quick to overrun the turf of other, less bloodthirsty and more civilized, medical specialists.

DrRich in the past has attempted to warn his medical colleagues about the predatory nature of cardiologists. He has told how the cardiologists have driven the formerly proud and powerful cardiothoracic surgeons into a sad state of underemployment, how they have usurped the formerly sovereign territory of diabetes specialists, and how they are currently laying siege to sleep medicine and bariatrics.

And now, continuing his public service to the less robust medical specialists (whose great achievements, like all cardiologists, DrRich admires), he must reluctantly extend his words of warning to his friends, the neuroscientists.

Cardiologists began encroaching on the field of neurology many years ago, but only surreptitiously, when they took to blaming imbalances of the autonomic nervous system (i.e., dysautonomia) on mitral valve prolapse. In more recent years, somewhat more blatantly, they have attempted to take ownership of migraine headaches. And now, just last week, in a full frontal assault, cardiologists laid claim to Alzheimer’s Disease.

Neuroscientists, nobody is safe! Hide your women and children!

The pattern of behavior employed by the invaders is easy enough to spot. First, cardiologists call attention to an alleged association between some cardiac condition (a condition they will manufacture if necessary), and a non-cardiac medical problem. 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 “proven” that the non-cardiac medical problem is caused by a cardiac condition, patients who have (or might develop) that non-cardiac medical problem need to be referred to cardiologists, who, lo and behold, have invented a well-paying procedure to treat it, or at least, to study it further.

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, and it often requires mitral valve surgery. Fortunately, however, significant MVP is a relatively uncommon condition.

The problem is that 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 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 staple 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 transiently 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 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 on how hard the echocardiographer looks for it, and on how much the 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 is 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 car payment, doing echocardiograms in young patients with cryptic strokes. They’re just too darned rare. 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, it is at least possible that they could all occur simultaneously in a patient. 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 (as we have seen) 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 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.  This, again, is because an association implies cause and effect, at least when that implication can be helpful to someone.

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 all the stories. (He even has one of his own. If DrRich maintains a schedule of running at least 20 – 25 miles a week, he does not get migraines. If he quits running for a few weeks the headaches come roaring back. He has mentioned this decades-long and reproducible pattern to several neurologists and other specialists over the years. They conclude that DrRich – and this should not be a surprise to many of his readers – is nuts. But if cardiologists had a billable procedure that could make you exercise, you can bet they’d fold DrRich’s experience into their formal clinical guidelines.) In any case, merely performing PFO closures on a few migraine suffers was almost guaranteed to produce a patient here or there who would report a positive response. And despite the continued negativity of actual clinical trials so far, that’s what happened.

So, at least by anecdote if not by controlled trial, closing PFOs can cure migraines.

But now it gets even worse for the neuroscientists. Any neurologists 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 have a way of treating (at least preventing, if not actually curing) Alzheimer’s Disease.

This time it is DrRich’s own particular sub-branch of the cardiology tribe which is the culprit – the electrophysiologists.  In a way, it is a little disappointing for DrRich to see his EP brethren going in for the same, turf-grabbing sophistry used by lesser cardiologists. EPs are known for being more intellectually sophisticated than your typical heart doctor (who, after all, is a glorified plumber). Indeed (as he thinks he may have mentioned in the past), DrRich has a neurosurgeon friend who, when he wants to convey the idea that what he is doing isn’t quite as difficult as it appears, but at the same time what he is doing is, in fact, neurosurgery, will say, “It’s not exactly electrophysiology!” But of course, he may not say this anymore once he finds out what we EPs are up to.

Last week, at the Heart Rhythm Society Scientific Sessions, researchers presented a study suggesting that ablation procedures for atrial fibrillation are associated with a lower risk of Alzheimer’s disease. (Here’s some information on atrial fibrillation and its treatment for anyone who is 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. For a well-presented, comprehensive treatment of why the results of this study should be largely ignored for now, see Dr. John M’s blog. (It sounds like John M is as embarrassed by his fellow EPs in this instance as is DrRich).

But such objections as DrRich and John M may express are just quibbles. The headlines are already blaring: “Ablation Procedures For Atrial Fibrillation Prevents Alzheimer’s.” Whatever the details and limitations of this study, cardiologists can now treat Alzheimer’s. Mission accomplished.

Having duly (and humanely) called this problem to the attention of his neuroscience friends, DrRich would like to finish by emphasizing a larger point.

You can’t fight the Feds. When the sovereign 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 – to maximize quality and efficiency and the collective good), the affected medical specialists have a limited range of possible responses. And fighting the Feds is NOT among these available responses.  Better to fight the change of seasons.

So the affected specialists 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 displaced them. Strike out against other, weaker specialists, and take what’s theirs. If you can’t grow the pie anymore, then take the other guy’s piece.

DrRich is not passing any judgment on his cardiology brethren here. He is just describing what’s happening, as a public service. You neuro-types, he believes, have a right to be told what’s happening. You 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:

 

 PCPs: Here's All You Need To Know About Our New Healthcare System [14:47m]: Play Now | Play in Popup | Download (3)

DrRich has decided it is time to begin studying the 2700-page healthcare reform bill that the Senate passed on December 24, as that is the bill which will actually become the law of the land. In the fall, DrRich had spent quite a bit of time with the House bill. This was such a painful and useless exercise that DrRich decided he would not waste any more of his time with proposed legislation, but instead (as Nancy Pelosi has wisely suggested) would wait until Congress passed a bill so he could find out what’s in it.

Now, DrRich does not have the stamina to study the new law all at once, as a whole. He must bite off little pieces. And the first thing he sought in embarking on his study of our new healthcare system was evidence of how the new law would rescue the Primary Care Physician.

This is important, since everyone acknowledges that we have a severe shortage of PCPs already, and when we add 32 million Americans to the rolls of the insured, that shortage will become extremely acute. Further, we know that very few medical school graduates are deciding to become PCPs, and further, that the PCPs who are in practice today are becoming older rapidly, and many may not be around in 10 years (or even in 10 months, once this reform bill passes).

As we all have heard, our President and his Congress have explicitly recognized the problem, and have frequently explicated on the need to build up and support our beleaguered primary care workforce. They have promised that their healthcare reforms will aggressively address this issue. And it is largely due to this promise that prominent physician organizations, like the AMA (which really represents a relatively small minority of the medical profession) and the American College of Physicians (which represents a large proportion of internists, of whom many are PCPs), have come out in support of the President’s reform efforts.

DrRich believes, of course, that for the Feds to suddenly make themselves the champions of PCPs, after spending nearly two decades systematically rendering primary care medicine a completely untenable proposition for American physicians, would be an unlikely outcome for any reform bill. Just to remind his readers, here’s what DrRich has previously observed about the carefully engineered plight of the American PCP:

“Their pay is determined arbitrarily by Acts of Congress, not by what they’re worth to their patients or to the market, and indeed in this way PCPs have a lot in common with workers in the old Soviet collectives.

They are directed to “practice medicine” by guidelines and directives which are handed down from on high; guidelines which, being forcibly based on what is called “evidence-based medicine,” necessarily address the average response of some large group of patients to the treatment being considered and do not allow much if any latitude for an individual patient’s needs; and which are often promulgated less to assure the excellent care of patients and more to further the agenda of various and competing interest groups, professional, governmental and otherwise.

They are limited to between 7.5 and 12.5 minutes per patient encounter (depending on the third party that controls a given patient’s medical care), and the content of what must occur during those 7.5 minutes is strictly determined by sundry Pay for Performance checklists, so as to strictly limit any interchanges between doctor and patient that do not meet the approved agenda for such encounters.

Their every move must be carefully documented according to incomprehensible rules, on innumerable forms and documents, that confound patient care but that greatly further the convenience of healthcare accountants and other stone-witted bureaucrats who are employed specifically to second-guess every clinical decision and every action the PCP takes.

They are expected to operate flawlessly under a system of federal rules, regulations and guidelines that cover hundreds of thousands of pages in immeasurable volumes that are never available in any readily accessible form. If they do not operate flawlessly according to those rules, regulations and guidelines, they are guilty of the federal crime of healthcare fraud. Furthermore, the specific meanings of these rules, regulations and guidelines are not merely opaque and difficult to ascertain, but indeed they are fundamentally indeterminate – that is, no individual or group of individuals in existence can say what they mean. So, PCPs operate under a massive quantum cloud of rules as best they can, but their actual status (regarding healthcare fraud) is, like Schrodinger’s cat, fundamentally unknowable – until the “box is opened” (typically through criminal prosecution), whereupon the meaning of the rules is finally crystallized in a court of law, and doctors who had been practicing in good faith find that they have at least a 50- 50 chance (like the cat) of learning that they are actually professionally dead.

Worst of all, PCPs have been charged with the duty of covertly rationing their patients’ healthcare at the bedside, and they have been pressed to nullify the classic doctor-patient relationship, by the healthcare bureaucracy that determines their professional viability, by the United States Supreme Court, and by the bankrupt, new-age ethical precepts of their own profession.”

How does our new healthcare law propose to “fix” these problems? DrRich can find two proposed solutions in the Senate bill.

First, the new law promises to address some of the pay discrepancy which punishes doctors for going into primary care specialties. It is unclear to DrRich how much this new pay fix will bring to PCPs. He will merely observe that, until now, the Feds have intentionally rendered primary care medicine such a soul-wrenching, personally and professionally demeaning endeavor that it has pushed most PCPs beyond mere anger, frustration, or resignation. Many of them are desperately looking for any practicable exit strategy. And to DrRich’s thinking, since it is not primarily their relatively low income that has caused all this anguish, a mere boost in income cannot overcome it.

But, of course, that’s for the PCPs themselves to decide.

Second, the new law proposes to fund new training opportunities for PCPs. This also sounds nice. But DrRich wonders what effect these new training programs will have, when the training programs that already exist cannot come close to filling their slots.

DrRich contends that these two stated “fixes” for manufacturing more PCPs cannot possibly provide an actual solution to the PCP shortage, and further, that the authors of the Senate bill cannot possibly believe they will. And so, DrRich decided to look a little deeper.

The answer to the PCP shortage – at least, the answer our political leaders are actually relying upon – is revealed deep in the Senate bill, in Section 5501, where the definition of “Primary Care Practitioner” is actually provided. Note, first of all, that once this bill becomes the law of the land, “PCP” will no longer mean “primary care physician,” but rather, will mean “primary care practitioner.”

And here’s how the new law defines Primary Care Practioners:

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

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

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

And so, to his readers who are primary care physicians, DrRich must report that the real “fix” your political leaders have envisioned for the PCP shortage has been to declare you and nurse practitioners to be functionally (and legally) equivalent. This, DrRich submits, is all you need to know.

Having painstakingly reduced you unfortunate practitioners of primary care medicine to tools of the state – whose job is to follow the guidelines and place chits on the checklists which are handed down from on high, and to fill out the electronic forms which are designed not to advance patient care but to convenience the healthcare accountants who will thereby judge your “quality” – it is only natural for the central authority to eventually notice that you really don’t need all that training to do the kind of job they have invented for you. Nurses – who can be “trained up” much more rapidly than you, who will work for much less money than you, and who (they think) will be much less recalcitrant about following handed-down directives than you – will fill the gap. And you, doctor, can go pound salt.

DrRich must hasten to add, by the way, that, regarding the nurse practitioners, he believes the Feds have miscalculated. DrRich knows a lot of nurse practitioners and greatly admires their professionalism. He believes that “PCP” has been so successfully demeaned that many fewer nurse practitioners than our political leaders think will actually jump at the opportunity to become one (especially when you take into account the liability you assume when you become a PCP in a non-tort-reform paradigm like the one our leaders have made for us). Trusting in their common sense, DrRich will leave the nurse practitioners to their own wise counsel.

To his primary care physician friends, who have bravely held on, clinging to the promises made by our political leaders that their noble efforts will not go unrewarded, and to the assurances made by their own professional organizations that all will be well once the system is reformed, DrRich is forced to say: Told you so.

He also reminds you that it is still not illegal to opt out, and urges you to consider that it soon might be.

Last week, DrRich noted that the Covert Rationing Blog and the ACP Advocate Blog were named as co-finalists in 2009 Medical Weblog Award Competition, in the category of Best Health Policy/Ethics Blog. (Voting continues through Feb. 14.) DrRich, ever the opportunist, latched on to this fortuitous occasion to issue a challenge to Bob Doherty, author of the ACP Advocate blog, to engage in a debate over that very topic – medical ethics. He made this audacious challenge because the ACP is a chief signatory of a new code of “medical ethics for a new millennium,” formally promulgated in 2002 by an international group of medical professional organizations (a grouping DrRich has called – for convenience sake only – the Millennialists). And DrRich has taken great exception to this New Ethics, which, he asserts, does great damage to the doctor-patient relationship and to the medical profession. (DrRich details his objection to the New Ethics here, and describes the right way to do medical ethics here.)

A few days ago Mr. Doherty (who is also the ACP’s Senior Vice President of Governmental Affairs and Public Policy), graciously agreed to engage in this discussion, and promised to do so after consulting with the ACP’s Committee on Ethics, Professionalism, and Human Rights.

DrRich had hoped that Mr. Doherty would reply with a post on his ACP blog, which (since it likely has a vastly greater readership than the CRB), would more effectively give this topic some much-needed airing – and in particular, might engage some of the ACP’s membership (specialists in internal medicine) in this important discussion. DrRich was disappointed, then, when the reply came today in the form of a comment, which was tacked on to a long queue of reader’s comments at the end of DrRich’s posting.

DrRich was also very disappointed by the content of the reply which, fundamentally, was: This is a non-issue, and even if it was an issue, it’s now a settled issue. (So go away.)

Because he fears that his readers may not find the ACP’s response (buried as it is), DrRich will post it here in its entirety. But first he will very briefly summarize his complaint against the New Ethics promulgated by the ACP and other Millennialists. The New Ethics takes classical medical ethics (which obligates doctors to always place the welfare of their individual patients first) and adds on to it a new ethical obligation, called Social Justice, which obligates doctors to work toward “the fair distribution of healthcare resources.” This new obligation (which is to society) will inherently conflict, at least some of the time, with the physician’s traditional obligation to the individual patient. So, under the New Ethics, the doctor’s loyalty is now officially divided. DrRich asserts that this divided loyalty (which is now declared to be entirely ethical) leaves the patient in a dangerous position, and breaks the profession of medicine.

In the ACP’s response Mr. Doherty begins: “I asked Dr. Virginia Hood, chair of ACP’s Committee on Ethics, Professionalism, and Human Rights, to respond to Dr. Rich’s post. Her reply is below:”

Much ado?

We are surprised to see the comments about ACP and medical ethics. We urge readers to read the actual text of the ACP Ethics Manual (the College’s Code of Ethics) and the Professionalism Charter, which the College’s Foundation helped develop. Both say that social justice is a consideration in medical ethics, but the physician’s primary responsibility is to his or her patient. Resource allocation decisions are policy decisions and are most appropriately made at the system level, not at the bedside. The Ethics Manual discusses at length the clinician’s primary role as an advocate for individual patients. But it also notes the duty to practice effective health care and use resources responsibly, which are not incompatible with being a patient advocate. As the Manual notes, physicians should not overtest or otherwise overuse services:

Physicians have a responsibility to practice effective and efficient health care and to use health care resources responsibly. Parsimonious care that utilizes the most efficient means to effectively diagnose a condition and treat a patient respects the need to use resources wisely and to help ensure that resources are equitably available [i].

This is nothing new. Indeed using “effective and efficient health care and health care resources responsibly” for all patients is one way to minimize rationing as the result of an over costly system. The Manual also says that physicians and their professional societies should work toward ensuring access to health care for all and the elimination of discrimination, and deficiencies in availability and quality, in health care services. Likewise, the Charter on Medical Professionalism endorsed by ACP and 120 other medical organizations in the USA and internationally, states that professionalism involves commitments to improving quality of care, improving access to care, eliminating discrimination in health care, and yes, to a just distribution of finite resources. But the Charter explains the commitment to a fair distribution of finite resources as follows:

While meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited clinical resources. They should be committed to working with other physicians, hospitals, and payers to develop guidelines for cost-effective care. The physician’s professional responsibility for appropriate allocation of resources requires scrupulous avoidance of superfluous tests and procedures. The provision of unnecessary services not only exposes one’s patients to avoidable harm and expense but also diminishes the resources available for others [ii].

The patient-physician relationship and our medical ethics are the soul of medicine. The blog commentators are correct– it is important that we get it right.

Thank you.

Virginia Hood, MD, FACP
Chair, American College of Physicians Ethics, Professionalism and Human Rights Committee

As much as DrRich may feel he has been condescended to here (as if the ACP has found a fly buzzing around its head and has attempted to swat it away), and recognizing that the ACP has decided not to engage in a give-and-take (which, of course is their prerogative), but rather, has responded with a brush-off statement which they have chosen to bury in the comments section of DrRich’s obscure blog (which is also their prerogative), DrRich will attempt to reply as politely and as analytically as possible. (He does, however, sincerely hope that Mr. Doherty – who really seems like a good person and is an excellent writer – will not be called to the woodshed for obligating an august Ethics Committee Chairperson from this prestigious organization to issue a formal response to an annoying blogger such as himself.)

Dr. Hood’s artful (and dismissive, it seems to DrRich) statement can be fairly summarized thusly: After beginning with the implication that DrRich is making much ado (about nothing), and that she is surprised that anyone would dissent from ACP’s New Ethics, she says that the New Ethics does not entail the problem that DrRich alleges; indeed, there really is nothing new about it. Of course patients come first. (Just study the various documents the ACP has published on this point.) Cost-effective and efficient care is a part of good medicine, and always has been. What we mean by a fair distribution of finite resources is to practice medicine wisely, so as not to waste resources and not to expose patients to the risk of medical services they do not need. The legitimacy of the New Ethics is supported by the fact that it has been formally adopted by 120 medical organizations internationally (which to DrRich means that when you go to a doctor anywhere, this is the code of ethics under which they are now officially practicing).

There is a lot in her statement DrRich could comment on, but he does not want to bore his readers with a lengthy parsing of this finely crafted response. Rather, he will just talk about its main point.

Fundamentally, Dr. Hood is denying that there’s any problem. There’s no conflict between “the fair distribution of healthcare resources” and doing what’s best for individual patients – and furthermore, she’s surprised anyone would think so.

DrRich does not accuse her of sophistry. Perhaps she is just deceived.

The fact that there are huge conflicts between providing individuals with all the healthcare that would likely be useful to them, and the inability of society to pay for such a thing, is the fundamental problem with the public funding of healthcare. We simply can’t afford to buy everybody all the healthcare that would likely benefit them. There’s not enough money in the world to do that.

Consider just a few of the examples DrRich has discussed here over the years. Implantable defibrillators have been shown to significantly improve the survival of a substantial minority of patients who have heart disease, and indeed guidelines issued by cardiologists’ professional organizations indicate that defibrillators ought to be implanted at a rate of about five times their current actual implant rate. But if doctors actually did that, it would cost Medicare an extra $7 – $8 billion each year. Then there’s the fact that if doctors used the statin drug Crestor in the way the very well-designed and compelling JUPITER trial says doctors should use it, we would be spending an extra $10 billion per year on Crestor. In a thousand ways, the “best” healthcare for the individual is very often not cheaper (or better for society) than less-good healthcare, and DrRich is impressed that Dr. Hood is willing to say that it is.

Dr. Hood would likely deal with this problem, and implies so, by devising “guidelines” that doctors would be ethically obligated to follow. Obviously, it is entirely possible to convert “guidelines” from just that (i.e., a set of guidelines which doctors ought to take into strong account when deciding what’s best for their individual patients) into a set of formal rules that must be followed, and which will then be enforced by federal regulators (and their posse of ethicists). Indeed, such “guidelines” might be one of the ways in which society imposes its own goals over those of individual patients. But that is not the same thing as insisting that individual patients (who often do not fit the “average” profile) will necessarily profit if doctors always follow the guidelines as a matter of policy, or of enforced expectations, or of “quality”.

(Further, as DrRich has pointed out, the rapidly developing paradigm in which “guidelines” are becoming inviolate rules has led competing organizations to rush to issue their own sets of competing guidelines, that best comport with their individual agendas. While this phenomenon of “guideline wars” is endlessly amusing, it may not always serve the best interests of doctors or their patients.)

And then there’s the problem that, no matter how you define “waste” or “inefficiency” or “unnecessary care,” there simply cannot be enough of it to account for the runaway healthcare inflation we’re seeing (as DrRich has shown here). A substantial proportion of this fiscally disastrous healthcare inflation must necessarily derive from the delivery of healthcare that is actually useful.

So the crux of Dr. Hood’s reply – that all the ACP is talking about when it mandates that doctors fairly distribute limited resources is that they ought to practice good medicine, and if they did that simple thing no useful therapy would need to be withheld from any individual patient – is absurd on its face.

DrRich would be less disturbed by Dr. Hood’s assertion if he really thought it was simply a misapprehension of the truth. And perhaps it is. After all, her statement reads as if she is truly surprised that anyone would think otherwise.

Perhaps Dr. Hood came to her high station within the ACP’s Ethics Committee very recently, and is unaware of the history of the new Professionalism Charter which advanced this New Ethics, or of the controversy that was raised by many critics at the time of its adoption, or indeed, of some of the language that was in its penultimate version (and that was likely removed to silence some of those critics). Indeed, she cannot be aware if it, since she is “surprised to see” that anyone is bothered by the Charter, and since she believes that questioning it is but “much ado.” But to anyone who knows a little of that history, Dr. Hood’s assertion that controversy over this Charter is a novel experience, or most especially, her assertion that this New Ethics is really “nothing new,” would come as a very great surprise indeed.

First, we should note, if the new Professionalism Charter was really “nothing new,” and was just a restatement of the physician’s traditional obligation to place the patient first, and if fairly distributing society’s resources really was just a matter of practicing good medicine, then there would have been no need for a new Charter of medical ethics in the first place. And certainly the need would not have been pressing. It would have served quite nicely instead to produce some sort of document reminding doctors that unneeded healthcare services expose their patients to unneeded risk, so (based on the traditional ethical precept of patient welfare), to remain ethical they must stop being wasteful. Certainly, this kind of wasteful medicine would not produce a need to redefine medical ethics.

But the new Charter’s very first sentence describes something more dire, more pressing, than can be explained by Dr. Hood’s benign assertions. It says, “Physicians today are experiencing frustration as changes in the health care delivery systems in virtually all industrialized countries threaten the very nature and values of medical professionalism.” So: the whole purpose of this new Charter, its entire impetus, was the frustration of physicians.

Frustration? What frustration is that? Interestingly, the document does not come right out and say it. The closest it comes to spelling it out is to say, “We share the view that medicine’s commitment to the patient is being challenged by external forces of change within our societies.”

But even though the document seems strangely reticent about spelling out which frustration produced the very impetus for its creation, we can rely on the fact that the document must be designed to cure this mysterious frustration (whatever it is), and that the only revolutionary change in the document is an addition to the code of medical ethics requiring physicians to work for “the fair distribution of healthcare resources.” We can only conclude that this new ethical obligation is meant as a cure for that foundational frustration, and that therefore this frustration must be that doctors are finding it impossible to meet their traditional ethical obligation to to place their patients’ needs first.

But, as it happens, we do not really have to resort to this sort of documentary detective work to parse out the purpose of the new Professionalism Charter. That purpose was quite open at the time this document was being developed – and it produced robust controversy that was certainly no secret. One can read about this controversy in many places, but for our purposes now (i.e., in replying to Dr. Hood’s assertion that there’s nothing new here, and that it is a matter of some astonishment that anyone would find the Physicians Charter controversial) it might be best to refer to one of the ACP’s own publications from that time.

An article in the July, 2001 ACP-ASIM Observer, which was entitled, “Charter on medical professionalism addresses issues of finite resources,” goes into some length about the controversy. And it is very plain that the objection many raised to the new Charter was precisely that which DrRich is raising now in his challenge to the ACP: that the New Ethics being espoused in the Professionalism Charter fundamentally and explicitly divides the loyalty of the physician between the patient’s needs and society’s needs. When one listens to the defenders of the new Charter (quoted extensively in the ACP-ASIM Observer article), one finds the unmistakable tones of utilitarianism: We have to change our ethical precepts, the argument goes, because that’s just the way the world works now.

This article also indicates that the draft of the Physicians Charter presented to ACP general membership at their annual meeting in 2001, a few months before the final version was finally published, was perhaps more forthcoming than the final version, regarding what it was really all about. For instance, this nearly-final version of the Charter specifically admonished physicians that they must “be aware that the decisions they make about individual patients have an impact on the resources available to others.” One can only assume that this sort of explicit language was taken out of that final version in response to the critics (who were many, and vocal) to soften the blow.

Indeed, the “softer” language of this strange final version (which has all the hallmarks of a heavily edited document, beginning as it does with a heartfelt cry against the frustrations being experienced by physicians, then neglecting to spell out what those frustrations are, and never explicitly saying which aspect of the document addresses those frustrations), is now possibly soft enough, if not read carefully, to allow defenders of the Professionalism Charter to get away with asserting (as Dr. Hood has done) that the New Ethics is really pretty much the same as the old ethics, and does not change anything. (So move along, move along.)

But the New Ethics changes everything.

DrRich is very sorry about this, and is especially sorry that the ACP’s Ethics Committee, and the other 120 physicians organizations that have adopted this New Ethics, insist they do not see a problem here. DrRich assumes by this response that the ACP has little interest in revisiting its new ethical stance, and further, is undoubtedly busily training today’s medical students that doing what’s best for society is the same as doing what’s best for the individual.

This is a theme, DrRich thinks, he’s heard a lot lately.

Patients who want a true advocate in their life-and-death encounters with the healthcare system, an advocate whose loyalty is not divided between them and a society that, with increasing desperation, wants not to spend its money on them, had better go out and hire their own. Your doctor will now find it officially unethical to serve that office him-or-herself.

And meanwhile, we can now be sure that the physicians organizations which are responsible for protecting the ethical foundation of the profession of medicine are quite satisfied with the job they are doing.

As has been pointed out (pointedly) to DrRich, we do not have death panels in the United States. And indeed, considering that we’re not conducting military tribunals for Islamist terrorists who have tried (or succeeded in) killing and maiming as many of us as possible, it seems relatively unlikely that we’d assemble death panels (which sound even less due-process-friendly than military tribunals) for American patients.

What we will have, however, is a federally-mandated assembly, body, committee, commission, board, diet, parliament, or posse (but not a panel) of experts which will carefully evaluate all the objective clinical evidence regarding a particular medical treatment, and make “recommendations” to doctors about whether or when to use that treatment. The model which frequently has been offered up for our consideration, as we contemplate the workings of such a non-death-panel, is the British National Institute for Clinical Excellence, or NICE.

This being the case, it might be instructive to examine the preliminary decision made by NICE last week to disallow the use of the new antiarrhythmic drug, dronedarone (Multaq, Sanofi-Aventis) for British patients with atrial fibrillation (AF). Dronedarone is a long-awaited drug, painfully developed and tested over a very long period of time, as a potential replacement for the drug amiodarone (which, despite its many drawbacks, is the most commonly prescribed antiarrhythmic drug for AF).

AF is a common heart rhythm disturbance in the elderly and in patients with underlying heart disease. It can cause palpitations, dizziness, poor exercise tolerance and – because blood clots tend to form in fibrillating atria – often leads to stroke. Unfortunately, the antiarrhythmic drugs that are used to treat AF are either incompletely effective, or have potentially dangerous side effects, or both.

Indeed, as a group, antiarrhythmic drugs tend to be only moderately effective, and are toxic and poorly tolerated. Worse, one of the very nasty side effects sported by most antiarrhythmic drugs is the propensity to produce (paradoxically), sudden death from cardiac arrhythmias – a phenomenon we electrophysiologists like to call “proarrhythmia,” since this seems a less unnerving term than “sudden death.”

The reason amiodarone has become the most commonly used antiarrhythmic drug for AF is that it is measurably more effective than any of the other drugs, and better yet, tends not to cause proarrhythmia.

However, if Satan had wanted to invent an antiarrhythmic drug, he would have invented amiodarone. There are at least three features of amiodarone that render it diabolical.

First, as mentioned, the drug is obviously far more effective than other antiarrhythmic drugs, and does not cause proarrhythmia. So on its face, like most entrapping vices, it spins a certain appeal, one that lures doctors into using it far more blithely than they should.

Second, amiodarone has bizarre pharmacokinetics. Before it becomes fully effective, amiodarone needs to completely saturate the tissues of the body. During this “loading period,” which is generally several weeks in duration, large doses are typically used. Once the drug is deemed to be loaded, a relatively small daily maintenance dose can be used. This is because amiodarone is not excreted from the body like most drugs are, by the kidneys or the liver. Instead, amiodarone likes to stay in the cells “forever,” and for practical purposes you get rid of it only through the normal shedding of your body’s cells, such as skin cells and gut cells. This means that once you are loaded with the stuff, it’s a part of you for a long, long time – just about forever. (Amiodarone can still be detected in the blood for at least a year after the last dose.) Once you are on amiodarone, you’re on it.

And third, amiodarone has a unique and disturbing toxicity profile. Because it is stored in essentially every organ of the body, its side effects can affect almost any organ. And because amiodarone continues accumulating in your body as long as you continue taking it, the side effects can develop weeks, months, or even years after you begin the stuff. The side effects of amiodarone are almost too numerous to describe, but some of the more unique ones include:

• Amiodarone commonly causes deposits to form on the cornea – often leading to “halo-vision,” where looking at bright lights at night is like looking at the moon on a foggy evening.
• Amiodarone can cause a very striking and quite disfiguring blue-grey discoloration of the skin, generally in parts of the body exposed to the sun, producing an appearance which has been unkindly termed “Smurf syndrome.”
• Amiodarone often greatly sensitizes the skin to sunlight, so that even trivial exposure can cause a nasty sunburn.
• Amiodarone often causes thyroid disorders, both hypothyroidism (low thyroid) and hyperthyroidism (high thyroid). These thyroid problems are common with amiodarone, can be unusually difficult to recognize and treat, and are often disabling and even dangerous.
• Amiodarone can cause neuropathy of the peripheral nerves, and more disturbingly, significant ataxia (a severe gait disturbance and loss of balance).
• But the most serious side effect of amiodarone is pulmonary toxicity – lung disease. This can take several forms, from an acute respiratory distress syndrome that makes patients desperately ill, requires intensive care, and often results in death, to a more insidious, gradual, unnoticeable, “stiffening” of the lungs that both the doctor and patient can overlook until finally severe and irreversible lung damage is done.

And of course, given the drug’s extremely long excretion period, if any of these side effects should occur (and one or more of them occur in at least 25 – 30% of people who take the drug), you may be living with them (if indeed you remain alive) for quite a while.

As you can see, Beelzebub would be very proud.

When DrRich was a practicing electrophysiologist, his rule was to offer amiodarone only if the arrhythmia being treated was life-threatening or very disabling or disruptive to the patient’s life, and for which there were no other reasonable therapies, and only after a long, long talk about the potential risks. He has always been distressed that many of his cardiology colleagues appear to prescribe it so readily.

In any case it is no wonder that a substitute for amiodarone has been long sought – a drug that is as effective as amiodarone, that still has minimal proarrhythmia, and does not have the bizarre toxicity profile of amiodarone.

For years, hope has been high for dronedarone, whose chemical structure is very similar to amiodarone’s. As it turns out, however, dronedarone is an imperfect substitute. While the new drug appears to have amiodarone’s low proarrhythmia potential, and while it thankfully has none of amiodarone’s unique side effects (and indeed, appears to be quite well tolerated), dronedarone is not as effective as amiodarone.

Still, it has a decided advantage over amiodarone (much less toxicity) and over other antiarrhythmic drugs (low proarrhythmia), so in many patients who have AF it seems like it might be worth a try. It might not be effective in as many patients as amiodarone, but for those patients in whom it is effective, well, it’s effective. And if it doesn’t work well enough, you can always switch to something else.

Indeed, that’s how antiarrhythmic drugs ought to be used most of the time. Pick a drug that seems to provide the best available balance between effectiveness and side effects for a given patient and try it. If it is ineffective or causes problems, stop it and move to the next one. The more antiarrhythmic drugs that are available, the better the chance of eventually finding an adequate choice for your patient. (It is worth pointing our that once you try amiodarone, however, you are done with this trial-and-error strategy – once you are on amiodarone, you are, for practical purposes, always on amiodarone.) In any case, the appropriate choice of an antiarrhythmic drug, as in many areas of medicine, can only be made on an individual basis, and not on a population basis.

But alas, this is not how a Clinical Effectiveness Tribunal like NICE works. These Diets of Medical Quality will only look at the average response to a therapy within a population of patients and, seeing (for instance) that dronedarone may only treat 40% of AF patients effectively while amiodarone treats 60%, will deem dronedarone to be insufficiently effective to justify its additional expense. (Read NICE’s “appraisal document” on dronedarone for yourself.) NICE has determined that amiodarone is a suitable choice for the treatment of atrial fibrillation, and that there is no need for a drug like dronedarone (or, presumably, any new drug that trades a bit of efficacy for a toxicity profile that is much less extravagant than that of amiodarone).

Old-fashioned physicians like DrRich, who might reason, “An initial trial of dronedarone would likely spare 40% of my AF patients from having to be exposed to the horrific toxicities of amiodarone, so perhaps it’s worth a try,” are hopelessly and irredeemably of low quality, and aren’t worth bothering over.

And as for the Smurfs and Smurfettes on amiodarone, despite their breathing difficulties, unsteady gaits, inability to see at night, and severe skin photosensitivities which preclude their Florida or Arizona vacations, at least their anguish over not being allowed a viable and available alternative will be temporary. For the drug companies, seeing how a Posse of Clinical Excellence operates, will take the only logical business step remaining to them and severely curtail their development of drugs aimed at offering incremental improvements over the current choices.

There will be no alternatives to agonize over, and everyone will be happy. This, DrRich thinks, is the plan.