Medical Ethics Smack Down 3 – Much Ado?

DrRich | January 26th, 2010 - 10:56 am

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.

Medical Ethics Smack Down 2: Medical Ethics the Right Way

DrRich | January 22nd, 2010 - 11:02 am

In his last post, and not without some little trepidation over the propriety of doing so, DrRich offered to enter into a “constructive dialogue” with Bob Doherty of the ACP Advocate Blog, regarding the important topic of medical ethics. What occasioned this offer was the fortuitous selection of each of us as finalists in the 2009 Medical Weblog Award Competition, in the category of Best Health Policy/Ethics Blog.

Ever since the inception of the Covert Rationing Blog (and even before that, in his book) DrRich has taken strong exception to the new code of “medical ethics for a new millennium,” formally promulgated in 2002 by the American College of Physicians and several of its equally respected sister organizations (a grouping DrRich has termed the Millennialists). And when he saw that the ACP Advocate Blog (an official publication of a principle component of the Millennialists) had become a co-finalist for a Weblog Award in the category of medical ethics, DrRich could not resist offering to engage in a discussion over same.

DrRich is delighted to report that Bob Doherty, who, in addition of being the author of the ACP Advocate Blog, is also the ACP’s Senior Vice President of Governmental Affairs and Public Policy, has graciously agreed to the suggested exchange of ideas. Mr. Doherty reports that he will be posting a reply to DrRich’s “challenge,” once he finishes consulting with the ACP’s Center for Ethics, Professionalism and Human Rights. And so, dear readers, it appears that DrRich (your humble correspondent) has gotten himself into a situation. It appears he will be engaging – at his own instigation, no less – with actual, certified experts on medical ethics, regarding the topic: medical ethics.

DrRich can almost hear some of his loyal readers gasping: “Why, he’ll be skinned alive!”

But fear not. DrRich will not hurt him. DrRich does not flay anybody, and promises to remain entirely civil and friendly in this exchange. DrRich, upon his honor, will see to it that Mr. Doherty (and whatever friends he may enlist in the cause) will emerge from this encounter entirely intact, integumentarily speaking.

In fact, to show his great good faith (and to level the playing field), DrRich will now break with all the conventions of debate, and before Mr. Doherty posts his reply, will lay the rest of his cards upon the table, so that the opposition will have the advantage of knowing ALL of DrRich’s arguments before they commit themselves to an answer. That is how dedicated DrRich is to keeping this competition friendly and respectful and fair.

DrRich’s Argument So Far

In his previous, challenge-issuing post, DrRich described how the “New Ethics” advanced by the Millennialists obligates the physician to strive for the ethical precept of Social Justice, which is to say, for “the fair distribution of healthcare resources.” So the doctor is now charged with deciding which patients may receive, and which may not receive, certain healthcare resources. To say it another way, under this new conception of medical ethics the doctor is assigned the duty to ration healthcare, covertly, at the bedside.

DrRich further described how this New Ethics fundamentally wrecks the doctor-patient relationship, and thus leaves patients to their own devices within a hostile healthcare system. In addition DrRich asserted that, once they adopted this New Ethics, physicians surrendered their claim to the title “professional,” and accordingly, made themselves fair game to whatever treatment, tactic, or travesty that any more powerful interest group (such as trial lawyers or Congress or regulators or insurers) may choose to foist upon them. Physicians no longer have any ethical standing for turning such attacks aside. Rather, as non-professionals, their ability to withstand attacks can only be proportionate to whatever socioeconomic or political pressure they can muster. So, as DrRich sees it, the New Ethics promulgated by the Millennialists is pretty much a disaster for both doctors and patients.

This is the extent of the argument DrRich has advanced so far.

Here Are The Rest Of DrRich’s Cards

The Millennialists did get one thing right in this effort. They correctly diagnosed the fact that old-fashioned, “classic” medical ethics, as advantageous as it may have been to both patients and doctors, is no longer consistent with reality.

Under classical medical ethics, the doctor’s one and only ethical obligation was to the individual patient. And so, classic ethics did not allow for any limits whatsoever on the medical services a patient may receive. If some bit of available medical care might offer even a small nugget of hope, doctors were obligated to provide it, no matter how expensive it might be to do so.

It is important to recognize that classic medical ethics evolved during a time when medical technology was relatively primitive, limited, and cheap, and more importantly, at a time when patients paid for their own healthcare. So when classic medical ethics was formulated, “healthcare spending limits” (though nobody talked in such terms back then), were self-imposed, by the patient.

But over the past 60 years medical technology has become very advanced and very expensive. And even more to the point, we have evolved a payment system in which people who receive healthcare are spending not their own funds, but rather, are spending publicly-funded, pooled resources. (Those pooled resources are either funded directly through the government, or are subsidized by the public indirectly, through tax-deductable insurance premiums).

It is this collective funding arrangement that has made classic medical ethics obsolete. It is neither feasible nor ethical to leave all decisions on how to spend society’s pooled healthcare dollars to individual doctors and individual patients, who can “take” as much of this pooled resource as they think they’d like to have, with absolutely no constraints. Such an arrangement eventually and inevitably leads to fiscal ruin.

By the 1990s, because spending limits were absolutely necessary, but at the same time classic medical ethics precluded setting such limits, doctors were being coerced by the private insurers and government payers to establish those limits covertly, through bedside rationing. This was the problem faced by the Millennialists when they set out to reformulate medical ethics, and they were right to make the attempt.

But unfortunately, this is where the Millennialists dropped the ball and, as DrRich has shown, settled upon an answer that just made things worse.

The Right Medical Ethics

Medical ethics would be “right” if it could be made to comport with the classic notion that the doctor’s primary obligation is to his/her individual patients (thus preserving the classic doctor-patient relationship), and yet still respected society’s need to control the spending of its pooled resources. That is, the “right” ethics will recognize both society’s needs and the needs of individual patients, will recognize that those two sets of legitimate needs are often in conflict, and will provide an ethical framework for resolving these conflicts.

That ethical framework, DrRich is pleased to announce, is not that hard to conceptualize.

We can solve this problem if we think of the ethics of healthcare as being organized into two concentric spheres. The outer sphere holds the ethical precepts adopted by society to guide the behavior of the healthcare system for the benefit of the entire population; for example, to set overall limits on spending. These outer-sphere precepts help to ensure that the needs of society as a whole are served in an ethical manner by the healthcare system.

Contained within (and therefore subject to) that outer sphere of societal precepts is an inner sphere, which holds the ethical precepts that govern the behavior of individual doctors and patients within the healthcare system. Inner-sphere precepts help to ensure that the rights and needs of individual patients are addressed in an ethical manner.

So, while the physician’s primary ethical obligation must always be for the benefit of the individual patient, and therefore the physician must operate according to ethical precepts that honor this duty to individual patients (the inner-sphere precepts), their behavior must also conform with the ethical constraints imposed by society on the entire population (the outer-sphere precepts).

We can think of the inner-sphere precepts as an immutable core of ethical beliefs that serve the fundamental American commitment to the autonomy of the individual, and of the outer sphere as a coating, fashioned by society and therefore changeable, that places an adjustable (and ethically derived) limit on the individual’s ability to consume pooled resources.

The Inner Sphere – Ethical Precepts For Individuals

The inner sphere of ethical precepts – the core – fully preserves the two precepts of classic medical ethics: the precept of Patient Welfare, which requires the doctor to always act to the benefit of his/her individual patient; and the precept of Patient Autonomy, which requires the doctor to respect the individual patient’s right to medical self-determination. So the inner sphere precepts completely restore the physician’s sacred obligation to the interests of their individual patients. And thus, also restored are both the classic doctor-patient relationship, and medical professionalism.

But while individual welfare and individual autonomy are critical (and comprise the chief ethical obligations of the physician), there are still legitimate limits to what the patient (and doctor) can reasonably expect to receive from pooled resources. When a patient demands that everything possible be done for them, they are exceeding the bounds of autonomy if doing “everything” means that other individuals would thereby be deprived of what otherwise would be rightfully their fair share of those pooled resources. These necessary bounds on individual autonomy are defined by the outer sphere.

The Outer Sphere – Ethical Precepts For Society.

Under any equitable healthcare system we are going to have to carefully define our outer sphere ethical norms, because those are the standards that bound and govern the inner-sphere behaviors of individual doctors and patients. This “outer sphere ethics” is also comprised of two ethical precepts, Societal Beneficence and Distributive Justice.

Societal Beneficence (or social welfare) requires the healthcare system to attempt to maximize the overall public good realized from whatever pooled resources society expends on healthcare. Social welfare is not the same as patient welfare, because what is optimal for an individual patient may often reduce the overall benefit to society, and vice versa.

Distributive Justice requires the benefits of the healthcare system to be distributed fairly, that is, in a way that does not discriminate against individuals or groups based on who they are.

The outer-sphere precepts honor society’s right to accrue optimal benefits from whatever collective resources society provides toward healthcare. That is, the outer-sphere precepts recognize society’s legitimate interest in limiting and equitably distributing those collective resources – and indeed, recognizes its ethical obligation to do so.

Medical Ethics And the Spheres

With this framework it is easy to see why the American healthcare system is presently inequitable and unethical. A hallmark of our present system is the lack (thanks to our culture of no limits) of any attempt to define effective outer-sphere societal norms, which would bound the appropriate behavior of individual physicians and patients. This deficiency makes it entirely feasible, and very common, for some patients to soak up a disproportionate share of publicly funded healthcare resources, while others (though they are also paying into the system) are left with next to nothing.

Achieving equity should have nothing whatever to do with adjusting the inner-sphere precepts. Individuals in the United States (to paraphrase the Declaration of Independence) have a self-evident right to their individual autonomy. The inner-sphere precepts are granted to us by our founding documents, and as Americans we should avoid modifying the inner-sphere precepts at all costs, since, once we do, we are abandoning our foundational principles. (This means that the Millennialists have done more damage, with their New Ethics, than merely harming doctors and patients. They have begun – or continued – undermining the principle of individual autonomy upon which the United States was founded. ) (Sorry to have to mention it.)

It is the outer-sphere precepts – those that can be negotiated legitimately by society, and which can legitimately limit the scope of inner-sphere behaviors – that we need to get into proper order.

A properly functioning system of medical ethics, therefore, would require society to devise workable outer-sphere precepts, and through these ethical precepts, establish transparent rules for setting necessary limits on collective healthcare spending. Then, within that system of rules, doctors and patients would work together, under a fully restored doctor-patient relationship, to assure that every patient has access to all legitimately available medical options. And the doctor would be allowed (and expected) to leave no stone unturned in obtaining those legitimate medical services for his/her patient.

This arrangement is analogous to the attorney-client relationship, where the attorney, acting within the bounds imposed by the law (outer sphere norms), is expected to do everything within his/her power to see that the client gains every conceivable, allowable advantage (inner sphere behavior) as they navigate the complex legal system.

To further illustrate this point, we Americans are now engaged in a debate over whether the Christmas Underwear Bomber ought to be eligible to receive all the legal protections afforded to an American citizen under the law. It is notable that ALL the discussion in this case is in regard to whether American outer-sphere legal norms should apply to the terrorist. Nobody is suggesting that his attorney ought to abrogate his (or her, as the case may be) sacred “inner-sphere” obligations to this client, in order to achieve some sort of “fair distribution” of society’s legitimate interests. Nobody expects the terrorist’s attorney to refrain from advising him remain silent, for instance, even though that silence may expose us all to substantial additional harm. The lawyer’s inner-sphere obligations are secure, even here. Rather, the argument we’re having is strictly limited to how we should apply outer-sphere legal protections to this case.

It is the right argument to have. And it’s the very argument we should be having in regard to medical ethics.

And as much as DrRich does not like lawyers, he very much admires the tenacity with which they have preserved their fiduciary relationship with their clients – even in cases like this one. If physicians (and their organizations) had behaved with the professional integrity displayed by the despised attorneys, doctors and their patients would be in much less difficulty today.

A Plea

It is instructive to re-consider the New Ethics, which now has been formally implemented by the Millennialists, in light of DrRich’s proposed two-sphere system of ethics (which he audaciously labels “right ethics,” but to show his humility he will not use caps). The New Ethics can be seen to have resulted by the simple expedient of moving the outer-sphere principles of Societal Beneficence and Distributive Justice (lumped together as Social Justice) down into the inner sphere, where individual doctors are expected to deal with them.

You can’t actually do that, of course, because these are intrinsically outer-sphere norms. But nonetheless, New Ethics formally puts doctors into the position of having to serve the best interest of their patients (individual beneficence and autonomy) while at the same time, covertly rationing their patients’ healthcare (societal beneficence and distributive justice). It is quite impossible for individual physicians to reconcile these competing interests in any equitable sense, and charging them with the job of doing so is illogical, nonsensical – and (DrRich respectfully submits) unethical.

Doctors and patients would be much better served if physicians’ professional organizations, such as the ACP, would revisit their new-age Physician’s Charter on ethics. DrRich understands that our modern society is exceedingly reluctant to establish outer-sphere rules for limiting pooled healthcare resources, and for distributing them equitably. But that reluctance is not a sufficient justification for physicians themselves, through their professional organizations, to initiate and implement new ethical standards that sacrifice their sacred obligation to their patients.

My goodness, can we not muster up at least the ethical sensibilities of lawyers?

DrRich, the ACP, and Medical Ethics

DrRich | January 18th, 2010 - 11:06 am

Yesterday, DrRich noted (with his usual affecting humility, modesty, self-deprecation, &c.) that the Covert Rationing Blog has been named a Finalist in the 2009 Medical Weblog Award Competition, in the category of Best Health Policy/Ethics Blog. He now calls to his readers’ attention the fact that, among the other two finalists – both of which are of very high quality and undoubtedly are more deserving of this award than DrRich – is none other than the ACP Advocate Blog.

The ACP Advocate Blog, written by Bob Doherty, is a publication of the American College of Physicians, and its purpose is to explain, elaborate on and advocate for the ACP’s positions on important matters related to health policy and medical ethics that affect its members, namely, internal medicine specialists. Doherty – who DrRich does not know, but of whom he has heard many very complimentary things – is an insightful analyst of matters related to healthcare policy, and to boot he is an excellent writer. DrRich is a loyal reader of the ACP Advocate Blog, which in fact has habitually led off DrRich’s blogroll.

Here’s why this is interesting. While both the ACP Advocate Blog and DrRich’s blog are finalists in the medical ethics category, it so happens that DrRich and the ACP are far apart on that very issue. DrRich (himself formerly a proud member of the ACP for over 30 years) has been a vocal critic of the ACP’s stand on medical ethics, ever since it joined a group of professional organizations a few years ago to formulate “Medical Ethics for a New Millenium.” DrRich believes that this “new medical ethics” is harmful to patients and to the medical profession alike, and has not been bashful about saying so.

So here we are – DrRich and the ACP Advocate Blog – both selected, as fate would have it, as co-finalists in the venerable Medical Weblog Award Competition in the category of medical ethics, when, regarding this very topic, the former has been quite vocal and persistent about criticizing the latter. Meanwhile, DrRich’s effusions on the subject have been completely ignored by the ACP in general, and by Doherty in particular. Now let’s be clear – DrRich does not blame them in the least for failing to respond to his criticisms, since they are very likely completely unaware of his existence (being, as he is, merely one tiny voice in a great sea of blogospheric pontificators). Also, truth be told, even if they were aware of DrRich’s criticisms, prestigious organizations such as the ACP do not owe a debt of response or recognition to every lone crackpot who criticizes them or their policies. If they had such an obligation, then how would they ever get any work done?

But still and all, here we are, fellow finalists.

So what, prithee, is the correct etiquette here? Quite likely, the correct thing for DrRich to do would be to avoid disharmony, to ignore the tension built-in to this unasked-for situation, to pretend there is no major point of contention over medical ethics between himself and one of the other medical ethics finalists, to spend the next couple of weeks writing about some other of his favorite subjects – how fat people prevent global warming, say, or on the most politically correct way to move old farts expeditiously into the next life – and, for propriety’s sake, to simply leave contentious medical ethics alone for another time.

But really, where’s the fun in that?

Plus, medical ethics is important. In fact, DrRich believes that the very point of contention, between the ACP’s conception of medical ethics and his own, is of such critical importance as to define the ultimate viability of the medical profession itself, and more importantly, the actual, physical (life-and death) viability of patients. And this being the case, it would be a shame – and possibly unethical – to let the subject just lie there, at the very time when taking it up might at last engender some of the give-and-take the subject sorely needs, and failing that, at least might gain a broader audience than it has had to date. (For DrRich has discussed this all before, but to little avail.) Such a broader awareness could be useful, since doctors and patients who fully understand the danger in which this new system of ethics has placed them can take the steps necessary to protect themselves (and each other).

And so, at the risk of being impolitic, impolite, boorish, boring, incorrect or incorrigible, and quite likely at the risk of rendering himself completely unworthy of his status as a finalist in the Medical Weblog Award Competition, and possibly even at the risk of forfeiting his status as same (though he has not been apprised of any particular rules he may be about to violate), DrRich hereby lays down the following proposition, and cordially invites the ACP Advocate Blog (or any other interested or offended party) to reply:

A Proposition

The New Medical Ethics, as espoused by the ABIM Foundation, ACP-ASIM Foundation, and the European Federation of Internal Medicine (hereafter referred to collectively as the Millennialists), and as laid out in a tract entitled, “Medical Professionalism in the New Millennium: A Physician Charter,” (Annals of Internal Medicine, February 5, 2002, vol. 136, pages 243-246), is deficient in the following ways:

  • it undermines the foundation of the doctor-patient relationship,
  • it threatens to fundamentally destroy medicine as a legitimate profession, and
  • it places patients at grave personal risk whenever they encounter the healthcare system.

Just so.

What’s Wrong With the New Ethics?

To see how the “New Ethics” declared by the Millennialists is harmful, it is useful to first review old-fashioned, or “classic” medical ethics.

Classically, doctors have been obligated to recognize two ethical precepts: Patient Welfare and Patient Autonomy.

The precept of Patient Welfare (also called the precept of beneficence, or “first, do no harm”), obligates the doctor to always behave in a way that accrues to the benefit of the individual patient. The needs of the individual patient come first, and must be the doctor’s primary concern, above, for instance, personal and financial considerations.

Under the precept of Patient Autonomy, patients are acknowledged to have the right to self-determination regarding their own healthcare. Fundamentally, this means that patients have the right to know, and the doctor is obligated to inform them, of any and all information that might help them make their decisions regarding their own healthcare.

So classically, doctors were obligated to do whatever they must to assure that their individual patients were fully informed about all their medical options, and to act to assure that their individual patients got the care they needed (as long as, fully informed, they agreed to it).

By the late 1990s, however, the Millennialists – quite correctly as it turns out – detected a severe problem with this classic medical ethics. Namely, modern physicians were, to a very large extent, unable to comport with it. Quite simply, this is because under a system of covert healthcare rationing (such as was in full bloom even by that time), doctors cannot follow these two precepts. It is not possible for doctors to ration healthcare covertly, at the bedside, and at the same time fully honor their patient’s welfare and autonomy.

The problem was explicitly recognized as early as 1998, in an article by Hall and Berenson in the Annals of Internal Medicine (volume 128, p 395) which stated: “It is untenable for the medical profession to continue asserting an idealistic ethic that is contradicted so openly in clinical practice. . .We propose that devotion to the best medical interests of each individual patient be replaced with an ethic of devotion to the best medical interests of the group. . .”

This influential article, among other things, led to the formation of a commission to study the issue (the issue being, apparently, that if it becomes difficult to follow ethical precepts, then one ought to go ahead and change them). And this commission led to the Millennialists and their New Ethics.

The innovation of the Millennialists was to proclaim a third ethical precept: the precept of Social Justice. The precept of Social Justice charges physicians with effecting “the fair distribution of healthcare resources.” That is, it directs doctors to decide which patients ought to get those limited resources, and which ought not to get them. It specifically and directly justifies bedside rationing by doctors.

The reason this third ethical precept was deemed necessary is explicitly because doctors cannot any longer adhere to the other two. (”It is untenable. . .to continue asserting an idealistic ethic,” according to Hall and Berenson. “Indeed, the medical profession must contend with complicated political, legal, and market forces,” [emphasis DrRich’s] according to the Millennialists.)

Ostensibly, the precept of Social Justice gives doctors who are too introspective (admittedly, not a big problem with many of us) an out when they find themselves having to place the interests of payers ahead of the interests of their patients by, say, failing to mention certain medical options that might be available. “Sure, I’m violating Precepts One and Two,” they can now tell themselves, “but I’ve got to do that to honor Precept Three.”

The bottom line is that, having been coerced by the the insurers and the government (who utterly control the doctors’ professional viability) to place the payers’ needs ahead of the needs of patients, doctors found themselves in utter violation of their fundamental ethical precepts. The proper response of physicians (and their professional organizations such as the ACP) would have been to reassert those ethical obligations, to push back against the payers, and enlist the cooperation of their patients (who, after all, have a particularly vital interest in the matter) in doing so. Instead, they have taken a path of lesser resistance, re-defining medical ethics to comport with their new, coerced behavior.

What Does This “New Ethics” Do To the Doctor-Patient Relationship?

The addition of the precept of Social Justice to the ethical obligations of the physician renders the doctor-patient relationship inoperative.

The doctor-patient relationship is critical to the professional survival of the doctor, but it is critical to the actual survival of the patient. Consider that patients – especially when they are sick – are no more capable of navigating a complex healthcare system (whose chief concern, increasingly, is minimizing spending at any price) than are, say, accused felons a complex legal system. And patients are no less in peril than the felon if they run afoul of that system.

Society explicitly recognizes the right of the accused felon to an advocate, a professional whose job it is to protect his individual interests against the conflicting aims of the “system,” and who is expected to leave no stone unturned in guaranteeing his rights and prerogatives under the law. A patient’s need of a similar advocate is no less acute than that of the felon. (When you are sick, you should be entitled to at least the same protections as when you rob a gas station.) And the doctor-patient relationship is supposed to see that you have such an advocate.

Over the ages the doctor-patient relationship has been defined, through rules of ethics and rules of law, as a fiduciary one. When a patient seeks a physician’s help and the physician agrees to give that help, a special covenant is made. The patient agrees to take the physician into her confidence, to reveal to him even the most secret and intimate information related to her health. The physician, in turn, agrees to honor that trust, and to become the patient’s advocate in all matters related to her health, placing her interests above all others – including the doctor’s own personal or financial concerns.

The New Ethics breaks that covenant from the outset. It renders “ethical” the divided loyalty of the physician. Today, when patients go to a doctor for medical advice, they do not know – and cannot know – whether that advice is being given to advance primarily the patient’s own well-being, or the well-being of the society that desires a “fair distribution of healthcare resources.” With the formal adoption of this New Ethics, patients have been essentially cut loose, and set adrift to fend for themselves in an increasingly hostile healthcare system, without being able to rely on the kind of personal advocate they’ve been conditioned to expect, the kind of advocate an accused murderer is awarded without question or hesitation.

Less obvious, but no less profound, are the consequences of this New Ethics to the profession of medicine. Abandoning their primary obligation to the individual patient means that physicians have committed the “original sin.” They have abdicated their traditional, ethical, and legal roles as patient advocates; they have broken a sacred pact. They have fully compromised themselves as professionals; indeed they have become professionals in name only, and not in fact. And as a result, to their utter frustration, they find themselves standing naked before their enemies, the very insurers and regulators who forced them to abdicate their sacred obligation in the first place.

DrRich finds it exceedingly sad that the ACP and other professional organizations, in an honest effort to protect their membership, and thus to devise a form of medical ethics which comports to the realities of the day, have ended up wrecking the doctor-patient relationship, and in the process have done great material harm to patients, and fatal professional harm to the very physicians whose ethical sensibilities they sought to protect.

DrRich does not imply evil intent to anyone here – not even to the insurance companies and the regulators (whose actions to coerce covert rationing are, really, just an effort to fulfill the job our society has assigned to them). Indeed, DrRich assumes all parties involved are sincerely trying to do the right thing. And so DrRich (ever your cheerful optimist!) sees a way out of the ethical dilemma.

That way out requires a new way of thinking about medical ethics – the “right” way, if he may be so bold – and in his next post DrRich will describe it.

In the meantime, DrRich is a bit distressed over his violation of the traditional civility of the blogosphere, for his possibly having abused the honor bestowed on him in his selection as a finalist in the Medical Weblog Competition, and indeed, for exposing himself to the accusation of initiating a Medical Ethics Smack Down. So if some of his readers choose to punish him for this untoward behavior by voting for the ACP instead of the Covert Rationing Blog, DrRich will understand.

Amiodarone is not NICE

DrRich | January 10th, 2010 - 8:41 pm

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.