Some might wonder why America needs a new book on fixing our healthcare system, now that the the Patient Protection and Affordable Care Act (i.e., Obamacare) has already done that for us. Well, there are several reasons, so take your pick:

1) Obamacare might be repealed.
2) Obamacare might be found unconstitutional.
3) If Obamacare is permitted to proceed into its full glory, it shouldn’t be long before it leads to social upheaval either by: a) exploding the federal deficit far beyond even what we’re seeing today; or b) alarming a critical mass of Americans regarding the new, oppressive powers which the new law grants to the federal government.

If 1 or 2, the process by which our nation will re-address healthcare reform may look much like the contentious, but deliberative, processes we have used in the past to reform certain aspects of our society. If 3, the process may look a lot more like Egypt.

In any case I think there is a reasonable chance that, in the next few years, we may be looking for a completely new way to reform our healthcare system, one that resembles neither Obamcare, nor the alternate and rather tepid “solutions” that have been proposed by the Republican leadership.

When that day comes, you will be very glad you took the time to read Douglas Perednia’s new book, Overhauling America’s Healthcare Machine – Stop the Bleeding and Save Trillions.

Perednia, something of a polymath, is an internal medicine specialist as well as a dermatologist, an NIH researcher, a writer, and an expert in telemedicine and medical informatics (he is a professor of this latter discipline). While he has founded and directed non-profit organizations, he is also an entrepreneur (which explains how he has become “New Zealand’s sole domestic source of boiler cleaner and glue for beer bottle labels”). He admits also to being a tap dancer (not that there’s anything wrong with that). And, as anyone will know who reads his excellent blog, Road To Hellth, he also knows a lot about the healthcare system.

Perednia’s book is a true tour de force – but don’t let that frighten you away. The author’s writing style is clear and conversational, easy to follow and entertaining to read.

In this style, he tells you everything.

Perednia does not pretend that American healthcare isn’t in dire need of the very kind of fundamental change that President Obama says he wants, nor does he pretend that a little insurance reform will do the trick. The healthcare system, he suggests, is on its last legs. It is a machine that is wearing out and bogging down, and it needs to be completely overhauled.

The healthcare machine is far more complex than it ought or needs to be. It is burdened by all manner of extraneous flywheels, gears, and gewgaws that were glommed on during its long history to please one long-forgotten constituency or another, that do nothing useful, but that consume a lot of fuel and deposit a lot of grime. The healthcare machine’s great creaking clockwork grinds away against all this unnecessary friction and accumulated grunge, and for all its strenuous efforts produces an ever-smaller amount of useful work. What this machine needs is more than some bright new attachments and smarter operators to oversee its churnings. It needs to be torn down and rebuilt.

Perednia does not pull his punches. He starts by showing that the American healthcare system, when its output is analyzed objectively and soberly, does not produce nearly as much good as its present apologists suggest. It certainly does not produce very much good in relation to all the money we spend on it. He then moves on to analyze the roles all the big players have within the healthcare system in producing all this waste. He amply demonstrates how the doctors, the hospitals, the insurers, the government (and, yes, the patients), behaving in a manner that is entirely consistent with the incentives the system has provided for them, with no especial evil in their hearts, and with no more than the natural, baseline amount of greed and self-interest that accompanies any human enterprise, operate in a grotesque ballet of waste and excess. He shows how the healthcare machine has reached the point where it simply cannot go much further, and that, like it or not, we’re going to have to do something about it. (Along the way, Perednia clearly demonstrates how Obamacare, far from representing any kind of fundamental departure, simply exaggerates the pathology.)

The strongest part of this book, however, deals with how to fix all this. Perednia begins by establishing what almost anyone would agree ought to be the goals of the American healthcare system – it must deliver effective and efficient healthcare services in a manner whose fairness to all Americans is commensurate with the contributions all American make to it, and it must be financially sustainable – at least to the point that its cost does not drive us to societal collapse. He then outlines a scheme that can achieve these goals.

I would be less than forthcoming if I did not mention that the broad outline of Perednia’s solution, as he graciously acknowledges, derives from my own book. That outline looks like this:

He proposes a 3-tiered healthcare system. The bottom tier, Tier 1, consists of self-pay healthcare. All individuals would be expected to pay a certain amount each year toward their own healthcare, say $2000 per individual, or $4000 per family. The funds for Tier 1 could reside in a Health Savings Account, which the individual would own. People with low incomes would have HSAs funded by the government. But everyone has the opportunity to own an HSA, and everyone controls the first $2000 of spending on their own healthcare (and keeps what money is not spent).

Once the individual exhausts their annual $2000 limit, their healthcare would default to a publicly-funded Universal Health Insurance Plan (Tier 2). The universal health plan – which would cover every American, even members of Congress – would operate under a system of open healthcare rationing, for the purpose of keeping public spending on healthcare on a reasonable budget. Perednia spells out the details on how such open rationing could be accomplished. Obviously, establishing any system for openly rationing healthcare would be a very difficult and exceedingly painful process. It seems very likely that only after experiencing great gouts of pain from our current healthcare system could we Americans be enticed to tackle such a thing. But Perednia (and I) postulate that such a circumstance may become manifest in the very foreseeable future.

Tier 3 is a completely voluntary, self-funded insurance product. Here, the health insurance industry would offer various levels of additional health insurance to people who want it, which will pay for services not covered under the open rationing in Tier 2. Health insurance in Tier 3 would begin to look like an actual insurance product (i.e., one that protects individuals against unforeseen, potentially catastrophic expenses), instead of the soup-to-nuts coverage of everyone’s heart’s desire that now passes for health “insurance.”

Again, this is just an outline. While my book did not take it much farther than this, Perednia takes his solution to the healthcare problem several steps beyond, and provides a very comprehensive plan. He discusses specifics of insurance reform, physician reimbursement, paying for goods and services, physician credentialing, government regulation, malpractice reform, addressing fraud and abuse, implementing electronic medical records that actually help efficient patient care (a particularly strong section of the book), and assuring that innovations in healthcare are encouraged. If you really want to know how to fix American healthcare, it’s all here.

Once Omamacare is repealed or declared unconstitutional, or once it goes forward in tact to accelerate the final implosion of our already-near-terminal healthcare system, smart people will find themselves looking for new ideas upon which to re-build American healthcare. Amidst all the cacophony about healthcare reform, however, there are really only very a few voices that are offering truly novel solutions. Doug Perednia has thrust himself to the front of that short list of visionaries with Overhauling America’s Healthcare Machine.

Please read this book, so that when the time comes you can tell your Congressperson (or perhaps by that point, your local Commissar) about it.

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Overhauling America’s Healthcare Machine is available in all bookstores, and at Amazon.

Podcast:

Ethicist-Assisted Suicide [ 16:39 ] Play Now | Play in Popup | Download (417)

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This is the third in a series of articles on End-of-Life Care and Covert Rationing.  The first two articles can be found here and here.
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In his previous post, DrRich attempted to satirize the lame attempts of certain payers to “inform” certain of their “covered lives” that, among all the wonderful options available to them under their truly comprehensive health plans, the medical service of physician-assisted suicide would be compassionately offered and cheerfully paid for. DrRich even offered, thoughtfully as usual, some free though invaluable advice to payers on how they ought to go about marketing assisted suicide as a cost-saving strategy, and to do so in a far more sensitive and less ham-fisted way than they have managed so far.

If the mark of good satire is that at least some readers will have difficulty discerning whether the satirist is serious or not, then DrRich is feeling genuinely Jonathan Swiftian today.  For some of his readers (one of whom e-mailed, “I can’t believe what I just read. This is sick.”) have taken his modest proposal for selling assisted suicide at face value.  This is not the first time DrRich has made unfortunate impressions upon readers through his (possibly inept) use of irony. Sadly, it almost certainly will not be the last.

But assisted suicide being such an important and ethically charged topic, DrRich feels obligated to clear things up once and for all. So what follows is DrRich’s honest assessment of the advisability of physician-assisted suicide, in which he will attempt to forgo entirely any satire or irony (though he admits to having great difficulty in controlling his sarcasm).

DrRich believes that physician-assisted suicide is a very, very bad idea.  He has two major reasons for this belief.  On a purely practical realm, embracing and systematizing physician-assisted suicide under any healthcare system that is actively engaged in rationing (whether overtly or covertly) will almost surely lead to some terrible abuses of the practice. In this regard you can either use your imagination, or read the history of Europe in the first half of the 20th century.

His second objection to physician-assisted suicide is based on a consideration of ethics. DrRich admits to being on shaky ground here because: a) he is not formally trained in ethics, and b) it appears for all the world that those who are formally trained in ethics have universally concluded that physician-assisted suicide is perfectly OK in every way.

Debating with modern medical ethicists, at least if you are merely a layperson, is mostly a losing proposition.  This is not because ethicists are intellectually (or even ethically) superior, but rather because they are adept in couching their arguments in arcane twists of logic and webs of jargon that make their arguments difficult if not impossible for the uninitiated to follow.  This technique, of course, places novices like DrRich in the position of having little choice but to accept the ethical bottom line without really understanding how the bottom line was reached. It reduces medical ethicists to a priesthood, and medical ethics to received knowledge.

But DrRich maintains that advancing unintelligible ethical arguments is, well, unethical.

So DrRich will now present his understanding of the chain of logic by which modern ethicists justify physician-assisted suicide – and its close cousin, euthanasia.  (If any of you actual ethicists out there object to this analysis, and can explain where DrRich is wrong in clear language, DrRich will be all ears. Absent the clear language, though, you can pound salt.)

Modern ethicists argue as follows:

Point 1: Our society has already decided that the autonomy of the individual patient is the overriding ethical consideration in making end-of-life decisions. We formalized this determination when we decided – by overwhelming consensus – that an individual has a right to refuse medical treatment even if that treatment is very likely to save their life. Therefore, individual autonomy is the universally agreed-upon controlling ethical precept.

And in adopting this controlling precept, we have already firmly decided that passive euthanasia – allowing nature to take its course by withholding treatment at the request of the patient – is ethical.

Point 2: There is no ethical distinction between passive euthanasia and active euthanasia. That is, whether we let death occur by withholding effective medical care, or by actually doing something to help death along a bit, we’re taking an action that hastens death either way. Ethically, both of these actions are equivalent. So, once we decide that individual autonomy is the overriding concern, we must also allow for active euthanasia when a patient wishes it.

Point 3: Once active euthanasia is deemed ethical, there can be no further ethical objection to the lesser act of physician-assisted suicide.  If it is ethical for a doctor him/herself to bring on the death of a patient who requests it, there can be no objection to doctors preparing the suicide machine and handing the patient the switch.

The striking thing here (to DrRich, at least) is that in establishing the ethical case for physician-assisted suicide, we necessarily also establish – as a veritable pre-condition – the ethical case for physician-provided euthanasia. Whether the patient says, “Help me to take my own life,” or “Take my life for me,” modern medical ethics supports the physician who replies, “Roll up your sleeve.”

For those who don’t see a problem with this, DrRich refers you to the Dutch system, where, in full accordance with modern medical ethics, the rules permit both physician-assisted suicide and active euthanasia for patients who request it. Reports on the results of the Dutch system (reports which both sides have used to bolster their respective opinions on either the glories or the travesties of such a system) do point out one striking finding – hundreds of times each year, acts of *involuntary* euthanasia are occurring. That is, patients are being killed under the Dutch healthcare system at the hands of their doctors, without their explicit permission. All these patients, it is claimed, are being euthanized for entirely humane reasons.

What do our friends the medical ethicists have to say about such involuntary euthanasia? Well, it turns out that it’s OK with many if not most of them. Ethicists don’t like to tell us that their chain of logic doesn’t end with Point 3.  But once we make the principle of individual autonomy the overriding consideration in determining end-of-life ethical issues, the same chain of logic takes us directly to Point 4.

Point 4: Since honoring the ethical precept of individual autonomy makes voluntary euthanasia available for patients with intractable suffering, it would be unethical to withhold the same benefit from suffering patients who are too incapacitated to give their permission. Their incapacity should not restrict them from a good that is available to others, for to do so would be discriminatory and inhumane. To cure this problem, the boon of active euthanasia can and must be performed, even without the patient’s explicit permission, in incapacitated patients whom “reasonable people” would agree are suffering too much. Therefore, involuntary active euthanasia is also ethical.

This conclusion, of course, leaves us in a place where others (i.e., “reasonable people,” like doctors or other agents of the Central Authority) can decide for an individual what constitutes intractable suffering, and further, can decide when such an individual is simply too incompetent to know that euthanasia is the best thing for them. Some of you, of course (hello, ethicists!) think this is just a fine idea. Most apologists for the Dutch system apparently do.

But DrRich maintains that under our system of covert healthcare rationing, where doctors are under extreme pressure to do the bidding of the third party payers (private insurers and the government) who determine their professional viability, and where the payers are under extreme pressure to reduce cost, and have already displayed in numerous ways their willingness to permit suffering and death among their subscribers in order to do so, then opening the door for physician-assisted suicide (let alone physician-administered euthanasia, whether the patient requests it or not), would inevitably lead to some nasty abuses, and would ultimately serve to undermine our civil society. DrRich is too politically correct to use the “other” N-word, but he will take this opportunity to remind his readers that such a thing has already happened, in what recently had been perhaps the world’s most cultured and educated society, within the memory of millions of living people.

DrRich believes that the principle of individual autonomy is vitally important, and indeed it is the foundation of American culture. However, no single ethical principle, no matter how important, can be allowed to overrule all other ethical principles in all other circumstances.  By nature, ethical precepts are often in conflict, creating what is called an ethical dilemma. And (DrRich humbly submits) it is supposed to be the job of ethicists to help us work through those ethical dilemmas, to find the right balance between competing principles, and not simply declare that no dilemma actually exists, because Ethical Precept A is the only one we need to pay attention to.

Individual autonomy is critically important to American culture – and the fact that we must fight to preserve individual autonomy in the face of covert healthcare rationing is indeed the underlying message of this blog – but in no other aspect of our culture do we let it absolutely rule. The autonomy of individuals needs to be checked, and we indeed limit it. This is the fundamental reason that governments are necessary in the first place.

The reason we have laws (supposedly) is to make sure that the behavior of individuals acting in their own interest, especially those who have accrued power (for instance, by accumulating great wealth, by acquiring large weapons, or by becoming heads of state), does not abrogate the natural rights of other individuals. Indeed, most of the political fights we have – between Democrats and Republicans or progressives and conservatives – are to determine where to place those limits, on individuals and on the collective, to best encourage a robust society that honors individual autonomy but that also encourages reasonably equal opportunities for individual fulfillment (i.e., “happiness.”) The main purpose of our public discourse, then, is to find the right balance between the rights and needs of individuals and the rights and needs of society as a whole.

So for ethicists to say, “Individual autonomy is all there is to it, and we have no choice but to follow that principle to wherever it may lead us,” is not only completely irresponsible and dangerous, it also flies in the face of our culture’s history and our everyday experience.  The cost to society not only should but must be taken into account as we consider institutionalizing physician-assisted suicide (let alone voluntary or involuntary euthanasia).  In DrRich’s opinion, ethicists who argue that we need not consider the cost to society in making end-of-life policy have declared themselves unworthy of the title and they ought to be completely ignored.

The cost to our society of institutionalizing and systematizing physician-assisted suicide, especially while we are still covertly rationing healthcare, would be severe and potentially lethal. Within the next decade or two, if things do not change, we likely will be facing cost pressures emanating from our healthcare system that will gravely threaten the survival of our culture. With an existential threat such as this, can we really refrain from slowly transforming the request for assisted suicide from an option to a duty? Can the Central Authority really stay its hand when it has the capability of directing its agents at the bedside to perform euthanasia on unfortunate (and unproductive) citizens who are too “incapacitated” to understand it’s the only thing to do?

DrRich, who opened this post with a promise to avoid irony, apologizes. For when all is said and done, it is deeply ironic that by steadfastly clinging to the ethical precept of individual autonomy at the end of life, within in a paradigm of covert healthcare rationing, we will very likely end up by completely devaluing the inherent worth of individuals.

At least until we solve the fiscal problems within our healthcare system, we simply should not embrace assisted suicide – no matter what we may think of the ethics of the act itself – and we should fight efforts to make it acceptable. The cost to our society would be far too high.

If people want to commit suicide and if medical ethicists insist that assisted suicide is OK, then let the ethicists do the assisting. DrRich has relatively little to say against ethicist-assisted suicide. But, at least as long as covert rationing is the chief operating principle of the American healthcare system, for the love of God keep the doctors out of it.

Podcast:

How to Sell Assisted Suicide [ 18:04 ] Play Now | Play in Popup | Download (276)

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

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In the summer of 2008, the Oregon Health Plan (the Medicaid plan in Oregon) injudiciously sent a letter to lung-cancer patient Barbara Wagner denying coverage for the expensive chemotherapy her doctor had recommended, and offering instead to cover palliative care “including doctor-assisted suicide.”

Despite the fact that there were plenty of distractions at the time (including a presidential election and the world’s economy on the brink of Armageddon), that letter unleashed a firestorm of public outrage. (If you have forgotten the outrage, simply Google the search terms “Barbara Wagner” and “suicide.”) Indeed, the outrage was sufficient to penetrate even the dulled sensibilities of the Oregon Health Plan’s executives. One Jim Sellers, a spokesman for the Oregon Health Plan, admitted to ABC News that “the letter to Wagner was a public relations blunder and something the state is ‘working on.’”

It is clear that the Oregon Health Plan executives were at least a little blindsided by the general reaction to their ham-handed denial letter. Denial letters, after all, are a routine activity, and they always list (as an aid to the patient) services which the third party payer judges to be reasonable alternatives to the denied care. While in this case the denied service which Ms. Wagner sought offered some reasonable hope for prolonged survival, and the service being held out by the Oregon Health Plan as an alternative (to say the least) did not, that’s really not so much different from the content of more “routine” denial letters. The difference is one of degree, and not of substance. So, Oregon Health Plan executives must surely have wondered, “What’s the big deal?”

One must try to be understanding of such insensitivity. It is a fundamental task of health plans – whether run by Medicare, Medicaid, or private insurance companies – to deliver unpleasant news to people whose lives are at stake, and it is normal (even necessary) for those who are charged with this task either to grow thick skin or to develop the traditional indifference of bureaucrats. It is perfectly predictable that such thick skin or indifference might dull one’s ability to discern subtle differences in degree among various denials of services, subtle differences that might call for more artful phraseologies than those employed in this instance by the Oregon Health Plan. The failure to recognize the need for a more artful denial letter, Mr. Sellers appeared to say, was the only problem in the case of Ms. Wagner. The solution, he therefore suggested, is certainly not a substantive change in any policy, but better public relations.

Those who ran the Oregon Health Plan must have been particularly disheartened to learn that even vocal proponents of physician-assisted suicide immediately began criticizing their ill-considered denial letter. To so blatantly juxtapose the reality of healthcare rationing with the “option” of assisted suicide seriously undermines the chief argument advanced publicly by the end-of-life movement, namely, that assisted suicide is merely an individual autonomy play, and is not in any way a cost-saving tool.*

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*Preserving the ethical precept of individual autonomy is the basis upon which modern utilitarian ethicists always build their defense of doctors ending the lives of their patients, whether it be by physician-assisted suicide, passive euthanasia, active euthanasia, and even involuntary active euthanasia. DrRich will elaborate on this ethical defense in a future posting.
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In other words, whether or not you embrace physician-assisted suicide, everyone seems to agree that offering it up as a covered medical service at the same time you are denying potentially life-prolonging therapy is both insensitive and unseemly.

And so – as a public service to those in the government and the private sector alike who are running healthcare organizations and thus who are (as a matter of course) severely challenged in trying to understand simple human emotions, to patients like Ms. Wagner who may suffer true physical harm by exposure to such institutional callousness, and to the rest of us who simply would appreciate not being confronted so blatantly by the dark abyss that underlies our healthcare system – DrRich offers the Central Authority and private insurers some friendly advice on the right way to sell physician-assisted suicide.

1) Don’t Seem So Anxious.

Sure it’s easy to get excited about physician-assisted suicide. All you need to do is look at your own data. Whether you are trying to make ends meet over at CMS, or running a private health plan, it’s likely that a huge proportion of your spending goes to patients who are in the last year of life. Enticing these end-of-lifers to choose assisted suicide (which you can accomplish in a sufficiently tasteful way for about $100) is such an attractive proposition that it’s indeed become very hard to make yourself appear reasonably circumspect about it. At the very least, if you run an organization like the Oregon Health Plan, where assisted suicide is “available” at no additional cost to patients who choose it, it’s difficult not to push the idea when the opportunity arises. Otherwise how can you be sure the patients will know all their options for end-of-life care?

But doing even that much is a mistake. If you don’t believe that, simply look at the small firestorm the Oregon Health Plan created with their straightforward and helpful “reminder” letter to Ms. Wagner. As a result of the Oregon Health Plan’s inept attempt at informing patients of their options, neighboring states that appeared ready to pass their own assisted-suicide laws immediately had second thoughts about it. It should now be clear even to health plan bureaucrats that seeming overly interested in assisted suicide, or even mentioning the option to patients (at least while simultaneously denying potentially lifesaving therapy) is a very counterproductive idea.

A much more subtle approach is required.

2) Publicly Disavow Any Interest In Assisted Suicide.

Think about Tom Sawyer whitewashing the picket fence. Ole Tom didn’t get all his friends to paint that fence for him by asking for their help, or by overtly trying to sell or cajole them on the idea. Instead, he got them to do the job by pretending he wasn’t the least bit interested in having them do it, by ignoring them altogether, and making himself seem completely absorbed in the delightful task. By the time Tom was done, his friends were begging for a turn, and even giving him wondrous gifts (such as dead cats on a string) to bribe him for a chance to participate.

What you need to do is pretend that encouraging assisted suicide – even if it’s a covered service that patients ought to be made aware of – is the farthest thing from your mind. Instead, you are completely invested in and insistent upon providing full-service end-of-life care, with all the bells and whistles and no holds barred; and – while patients of course have the option to exercise their individual autonomy as they see fit – you take great pride in squeezing every last instant of life out of those elderly, used-up, chronically ill bodies that present themselves in your ICU, no matter what the cost to the patient and family in terms of pain, suffering, humiliation and anguish. It is your mission to stave off death to the bitter end, come what may, and you’re proud of it.

3) Have Somebody Else Push It.

In the meantime, clear the path for agencies and interest groups which are dedicated to the end-of-life movement. There are plenty of them out there. Have them do the selling for you.

Make sure they have access to your patients and patients’ families, especially in the ICU setting. Allow them space for educational displays; provide them some private space where they can talk to interested patients and families; see that hospital social workers are aware of and will enable their activities. In the meantime, make it clear that you do not endorse or encourage their efforts, and indeed wish they would go away, but you are providing such groups with access in your dedicated interest of full transparency, and your commitment to patient choice. If patients choose to avail themselves of such information, you will do nothing to stop them.

4) Make the Advantages To Assisted Suicide Seem Real.

There’s no need for you to talk up the advantages of assisted suicide – let the end-of-life proselytizers do the talking for you. All you have to do is to make their arguments seem accurate. The great part is, that’s just a matter of maintaining business as usual.

The end-of-life zealots will tell patients that assisted suicide is a way of asserting some measure of control over the dying process, of holding on to some level of personal dignity at the very end. So simply make sure your end-of-life care continues robbing patients of any semblance of dignity and control.

They’ll tell patients that assisted suicide will end pain and discomfort and suffering when all hope of recovery is gone. So simply continue with inadequate pain control** and half-hearted comfort measures, and keep the ICU as hectic, loud, scary and impersonal as possible.

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**Maintaining inadequate pain control will continue as a matter of course as long as the Central Authority continues sending the DOJ after the occasional pain-management doctor. Whether the target physician is actually engaging in analgesic excesses is unimportant to the goal of making any American doctor afraid of aggressively controlling their patients’ pain, for fear of becoming a target themselves.
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The end-of-life proponents will tell the patients themselves that assisted suicide will finally bring comfort to their long-suffering family and friends, whose lives have been “so disrupted by your prolonged illness.” And make sure all those family and friends continue suffering long, by keeping those ICU waiting rooms hot, cramped, noisy, uncomfortable and smelly.

You get the idea. Simply make sure the arguments of the end-of-life proponents have teeth. You’re good at that.

5) Tell Patients to Consult With Their Doctors First.

That’s right. Refer patients to their doctors, their supposed personal advocates, the selfsame individuals you yourself have long since fatally compromised (by grabbing control of their individual professional viability). Assuming you have placed sufficient cost-cutting pressures on doctors, then their willingness to encourage (or at least not discourage) assisted suicide will be substantial. So when patients do consult with their doctors, the doctors will not undermine your subtle efforts, but will become your partners in convincing those approaching end-of-life to just be reasonable.

6) Make Physician-Assisted Suicide Legal, But Not Reimbursable.

You’re going for the Botox model here. You do not want physician-assisted suicide to be merely another hush-hush medical procedure, conducted quietly and almost secretly in a typical doctor’s office, so that people can pretend it doesn’t exist. Rather, you want to establish it as something that’s front and center, something people will want and ask for and go out of their way to seek. You want to encourage doctors to establish inventive business models for assisted suicide,  just as the dermatologists have done with their Botox clinics.

Accomplishing this, of course, will require assisted suicide to be made legal everywhere (and not just in Oregon and a few other progressive states), but at the same time will require you to NOT make it a reimbursable medical service. For once it’s made reimbursable it will become subject to typical Medicare price controls, which thus will keep prices high and limit innovation. And in this once instance, you will not want to limit innovation.

Just think of the possibilities: One envisions physician-assisted suicide becoming established as a “life cycle event” like a wedding or Bar Mitzvah, where the right atmosphere, the right spirituality, and the right tone come together to create an unforgettable, uplifting experience for everyone. Some assisted suicides will take place in a doctor’s office, of course, but why not in a place of worship, a favorite city, a resort, a mountain top, a rocky coast – a casino? Why not allow the prospective decedent to actually hear the eulogies and experience the tearful tributes before actually engaging (ritually) in the Act? Why not partner with the new deathcare industry you will be unleashing (talk about job creation!) to wrap this final “healthcare service” into a comprehensive package along with funeral services, grave sites and headstones, elaborate obituaries, and full coverage on Facebook, Twitter, and UTube?  Why not engage American media to celebrate the event with a new mode of reality programming (one that is sure to garner a massive share of viewers)? Why not, at last, GUARANTEE every American their 15 minutes of fame (even if it’s their last 15 minutes)? Why not convert what is today an antiseptic, impersonal and frightening process into one that makes everybody say, “Yes! That’s the only way to go!”

The beauty is that this sort of model will convert what is today, at best, merely the option for assisted suicide into something that’s expected – a true destination event, a natural part of life. Indeed, not opting for assisted suicide, at a certain point in one’s life, will come to be seen as unusual, unreasonable, greedy and selfish. And when granny begins to spend more time in a doctor’s office or (worse) in a hospital, where frequent visitation is expected and other family inconveniences are generated, some loving grandchild will pat her precious wrinkled hand, and say, “Granny, you know, it’s getting to be about that time. Wouldn’t a last weekend in Vegas be just the thing?”

So, if you play your cards right – passively encouraging the end-of-life movement in its effort to spread the word, while making the alternative (i.e., not committing suicide) as nasty and foul an option as possible, and also while coercing doctors and encouraging families to view assisted suicide as the most advantageous modus exodus one could ever imagine – well, the “right” to assisted suicide will shortly become the expectation and even the duty for assisted suicide.

If you who run government or private health plans will just follow DrRich’s simple program, you will have accomplished all this without seeming crass and self-serving, as you most certainly do each time you send somebody a letter like the one you sent the unfortunate Ms. Wagner.

Podcast:

Can Advance Directives Be Salvaged? [ 17:31 ] Play Now | Play in Popup | Download (272)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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DrRich’s Advance Directive:

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

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

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

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

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

Podcast:

A Gentle Reminder To Republicans From the Health Insurance Industry [ 8:57 ] Play Now | Play in Popup | Download (472)

Regular readers will know that DrRich is not enamored with Obamacare. Further, they will recall that DrRich’s chief objection to Obamacare is that it codifies into law the final destruction of the classic doctor-patient relationship.

Under Obamacare, the physician is not only released from her fiduciary obligation to her individual patient (i.e., the obligation to place the interests of the patient above all other considerations), but is strictly forbidden from acting in accordance with it. Indeed, elaborate mechanisms are established to assure that physicians will follow the directives which are to be handed down from omnipotent and immutable government panels, directives which will be explicitly aimed at optimizing collective rather than individual outcomes. And whereas physicians have long been discouraged from making healthcare decisions based on individual considerations and needs, Obamacare makes doing so a felony.

Combine that fact with inevitable future provisions that will prevent doctors from opting out of the system, and patients from spending their own money on their own healthcare, and you’ve got a prescription for a healthcare system (and a society) that are somewhat less friendly to individual needs, and somewhat more tyrannical, than supporters of Obamacare have promised us.

So, as a matter of principle, DrRich is sympathetic toward the newly-elected (and newly-reformed) Republicans who promise they will introduce and vote on a bill to repeal Obamacare.

But let’s be realistic. Even the most zealous Republicans understand that any repeal bill that passes in the House will stall in the Senate, and if it does not, the President will veto it. Indeed, it is this comforting assurance, DrRich thinks, that will induce many Progressively-oriented Republicans to go along with a repeal vote in the first place. By voting to repeal Obamacare, frightened and disoriented Republicans can mollify the Tea Party, without risking an actual abolition of the new reforms. Because if Obamacare were somehow repealed – well, where would the Republicans be then?

The health insurance industry, however, is taking no chances.

DrRich will remind his readers that Obamacare never would have become law in the first place if not for the solid and unrelenting support of the health insurance industry. The industry’s support for Mr. Obama’s effort was unfaltering. And during the long and perilous process that finally brought Obamacare to the President’s desk, whenever the cause faltered and appeared to be lost, representatives of the insurance industry would rise up and take whatever strong and difficult action was needed to get it back on track.

DrRich will further remind his readers that the insurance industry did not support Obamacare out of any principle, or compassion, or any sense of what was moral or right. They did it as a matter of life and death – theirs. For the health insurance industry had run out its string, shot its wad, blown up its business plan, and had nowhere else to turn. It was Obamacare – and its soothing “promise” to allow the industry to survive in diminished form, as a government-controlled utility – that offered insurers their only visible path away from oblivion.

The insurance industry is not about to go back. Furthermore, unlike Nancy Pelosi, Harry Reid and even President Obama, the insurance industry is not satisfied to let the political realities of the day block the Republicans’ efforts at repeal. For all they know, nervous Democrats in the Senate who want to be re-elected in 2012 will allow the repeal bill to go to the President’s desk. Worse, unused to seeing Presidents willing to sacrifice themselves on the alter of principle, the health insurers, in their existential panic, must wonder whether even Obama might finally change his mind and decide that he wants to be re-elected badly enough to sign a repeal bill. These possibilities seem pretty far-fetched to DrRich, of course, but to DrRich the prospect of repeal does not spell Armageddon.

During the long and painful process that saw Obamacare become law, the health insurers clearly demonstrated just how far they were willing to go to keep that process alive. DrRich is certain they will be happy to go at least that far to block repeal.

So it came as no surprise when, just last week, the insurers sent Republicans their first, gentle reminders that they will not countenance any such thing. At the Reuter’s Health Summit in New York, David Cordani, the CEO of Cigna, warned Republicans, “I don’t think it’s in our society’s best interest to expend energy in repealing the law. Our country expended over a year of sweat equity around the formation of it.” And Mark Bertolini, president of Aetna, said that any attempt to repeal Obamacare, or even an attempt to hold up funding for it, would be “problematic.” “We can’t go back,” said Bertolini,  “We need to keep moving, and we need to improve upon what we have.”

These seemingly mild-mannered statements should send a chill up the spines of Congressional Republicans. Any repeal of Obamacare necessarily and utterly relies on the acquiescence of the insurers, on their desire (or at least willingness) to continue with their current business model (possibly with some tinkering around the edges). Republicans, bless their innocent hearts, assume that’s what the insurers want.

But the truth is that the insurers know that their current business model is completely defunct, and far beyond any salvation. They see Obamacare as their only visible lifeline, and any serious threat to Obamacare as a threat to their survival.

The health insurers simply will not countenance a repeal of Obamacare. They will do whatever is necessary to demonstrate this fact to the Republicans. Their initial foray is suitably gentle. But once the repeal effort gets revved up, watch out. The insurers have already graphically demonstrated just how ungentle they can be.

If the Republicans really want to get rid of Obamacare, they’re going to have to propose an alternate solution that, among other things, provides the health insurance industry with a new and viable business model, one that seems at least as good to them as the rather paltry one Obamacare has promised. (If the Republicans want such an alternate solution, they have only to ask DrRich.)

DrRich does not think the Republicans have any idea of what may be coming their way, and from the very industry, no less, they consider to be their chief ally in the healthcare wars.

They should pay more attention.

Podcast:

How the Obesity Crisis Is Like the Mortgage Crisis [ 16:00 ] Play Now | Play in Popup | Download (718)

Q. What’s the difference between a public health expert and an incompetent doctor?
A. An incompetent doctor tends to kill only one person at a time.

The deep recession and jobless “recovery” which we have enjoyed in the U.S. for going on three years now was triggered by the bursting of the housing bubble. The housing bubble was created by lending practices that awarded “subprime” mortgages to people with bad credit ratings, and offered to people with good credit ratings adjustable-rate mortgages (ARMs) that enticed them to purchase more expensive homes than they could afford.

Traditionally, banks were always reluctant to award mortgages, of any flavor, to people who obviously could not afford them, since doing so would wreck their businesses. The reason the banks began making bad loans in the 1990s is that new government policies, chiefly the Community Reinvestment Act, strongly “encouraged” them to.

The banks, being businesses, reacted logically to the new regulatory climate, to threats by ACORN and other activist groups, and to the escape hatch opened for them by the government which allowed them to turn over their toxic mortgages immediately to Fanny and Freddie.  Banks quickly began turning out as many questionable mortgages as they could write, to as many uncreditworthy individuals as they could find.

Fannie and Freddie, in turn, securitized all those bad loans into complex investment instruments, which they released into the general worldwide marketplace. Investors around the world were happy to take these questionable new instruments since Fannie and Freddie, tacitly at least, were backed by the United States government.

And so, when the unqualified homeowners, who never had any prayer of making long-term payments on their mortgages to begin with, proceeded (at the very first and gentlest whiff of a recession) to default on their loans, the whole structure rapidly collapsed, nearly causing a global financial Armageddon.

Thank goodness us U.S taxpayers “volunteered” to clean up the whole mess with our taxes and those of our children and grandchildren.

There’s plenty of blame to go around for causing the mortgage crisis. We can blame all those people agreeing to mortgages they could not afford, the banks pushing mortgage deals on people who clearly did not understand what they were getting into, and Fannie and Freddie infecting the worldwide investment structure with toxic instruments. But the root cause was bad government policy.

Establishing policies that compelled banks to award mortgages to people who could not afford them (in order to advance the noble goal of creating a nation of homeowners) may seem like a compassionate thing to do. But the laws of economics are like the laws of nature. You can’t change them by government fiat. All you can do by fiat is to get people to behave in new and possibly unpredictable ways. And when those irreducible economic laws finally come around to assert themselves, you will be surprised, and likely dismayed, by the result.

As it turns out, setting health policy can have much the same kind of result. If you fail to pay sufficient attention to certain irreducible laws of nature – such as the laws of human behavior, and the laws of human physiology – you may not get the effect you are looking for (or, at least, not the effect you say you are looking for).

And this brings us to the obesity crisis.

Whether or not you agree that obesity is a “crisis” in the U.S., or even that mild to moderate obesity is the medical disaster it’s often painted to be, you’ve got to admit that Americans have gotten substantially fatter over the past few decades. And whether or not our increased corpulence is a grave threat to life and limb, it is creating an opportunity for the government to seize control over our individual freedoms – so it is, in fact, an important phenomenon.

DrRich is not the first to suggest that the public health policies of that very government substantially contributed to our obesity crisis. But as we enter a new era of Progressive healthcare, in which medicine is going to be practiced by policy fiats instead of by individual decision-making, it serves us to remind ourselves just how much the obesity crisis is tied to the great push, instigated by government policies dating back to the 1970s, for everyone to eat low-fat diets.

An association between dietary fats and coronary artery disease was first noted in the 1950s. In 1957, the American Heart Association (AHA) published its first, tentative recommendations for limiting the consumption of saturated fat. The recommendations were specifically aimed only at people who had strong genetic predisposition to heart attacks or strokes, or who already had heart disease. An accompanying editorial by Herbert Pollack, in the August, 1957 issue of Circulation, specifically warned against the widespread application of the recommendation to avoid saturated fat:

“Altering the dietary habits of a large population group is fraught with a great many dangers. Our knowledge of nutrition is not sufficient at this time to anticipate what ultimate results would happen if the public were encouraged to alter radically their basic dietary patterns.”

The AHA’s recommendations regarding saturated fat in the diet received sparse attention for 20 years. Then in 1977 (during arguably the second most Progressive administration in our history), the Senate’s Select Committee on Nutrition and Human Needs, chaired by George McGovern, nationalized the question of fat avoidance. After holding a series of hearings which tied fat consumption to heart disease, the Committee published the first “Dietary Goals in the United States,” advising all Americans to cut back on fat consumption. With this report, the US government officially supported low-fat diets for everyone.  (The public then was judged to be just as stupid as we are judged to be today, so any real effort to distinguish between unhealthy fats and healthy fats was quickly set aside. “Fat is bad” is a message you can sell even to gun-toting Bible-thumpers.)

The anti-fat boulder got a great big push down the hill in 1983, when the Framingham study published a landmark paper tagging obesity as an important risk factor for cardiac disease. Because eating a diet high in fat obviously caused obesity, it seemed self-evident that low-fat diets would prevent heart disease both directly, and indirectly (by preventing obesity).

Accordingly, in 1984 the NIH issued a Consensus Statement entitled “Lowering Blood Cholesterol to Prevent Heart Disease,” which amounted to an all-out attack on dietary fat. Many scientists pointed out that there really was a lack of convincing evidence demonstrating that low-fat diets would be healthful. But the majority, seeing an epidemic of heart disease which must surely be due to fatty diets, outnumbered the reticent ones, and the Consensus Statement was voted into publication. Then, when the AHA abandoned its earlier caution and endorsed this Consensus Statement, the scientific backing for the government’s public policy encouraging low-fat diets for everyone was fully in place.

This action finally ignited the great low-fat diet era. Spurred on by government policy, prestigious medical organizations and others began a campaign of public service announcements and media blitzes. Influential magazines (that is, magazines read by women) began a prolonged onslaught of low-fat diet tips, articles, and human interest stories emphasizing the deadly nature of dietary fat. The food industry, which was at first very skeptical (like the banks when subprime mortgages were initially foisted upon them), finally jumped in with both feet. A massive new product line of low-fat and no-fat snack foods were invented which were just packed with carbohydrates, and often with supposedly “healthy” man-made trans fats. (This major shift in food production has been referred to as the “Snackwell phenomenon.”) The AHA found a lucrative new revenue source officially certifying such low-fat, high-carb products (including Frosted Flakes and Pop-Tarts) as being “Heart Healthy.”

Americans, being filled with the milk of human nature, largely ignored the ubiquitous pleas to abandon their burgers, pizza and tacos in favor of broiled, skinless, sauceless, saltless chicken breasts and broccoli. But they did begin scarfing up the new-age low-fat snack foods in massive quantities, having been assured that, as long as the snacks contained no fat, they could eat as much as they wanted.

There are a few physiological facts about dietary carbohydrates that were largely ignored during the low-fat era. First, the body greedily converts dietary carbohydrates into massive stores of adipose tissue, so indeed you can readily become fat by eating carbs. Second, gorging on the refined carbohydrates found in these new “healthy snacks” causes huge spikes in insulin levels (insulin being a key factor in converting excess carbohydrates to fat).  When the insulin levels suddenly drop a couple of hours later, that drop produces insatiable hunger. So, two or three hours after enjoying a fat-free Pop-Tart or a Snackwell cupcake, one is ripping the cubboards open to find another carbohydrate fix. By thus inducing a continuous-snacking mode, the new high-carb snack foods increased overall caloric intake far beyond the calories listed on their labels.  Third, diets high in refined carbohydrates increase triglyceride levels, reduce HDL cholesterol (“good cholesterol) levels, and in general create lipid profiles that are quite damaging to the arteries.

So, while few people actually stuck to a strict low-fat diet, many, many people became addicted to refined carbohydrates, and as a result became fat.

It has only been in the past five or six years that the low-fat dogma has begun to moderate, largely thanks to the (now mercifully faded) low-carb craze that struck at that time.  We now hear somewhat more reasonable advice about good fats and bad fats, and good carbs and bad carbs. But much of the damage has been done, and at least partially because of the major push for low-fat diets, we Americans are fatter and less healthy than we used to be.

By the way, to this day it has never been shown that low-fat diets applied across the population would reduce the incidence of heart disease.

The low-fat diet policy amounted to a massive public health experiment, with the research subjects being us. Our government and our scientific organizations have yet to apologize for subjecting all of us to this travesty.  Indeed, like the outcome of the great experiment in subprime mortgages, the outcome of the low-fat experiment is not particularly chastening to our Central Authorities. In fact, it works to their advantage.

To see why, consider the final way in which the obesity crisis is like the mortgage crisis. To prevent another mortgage crisis, our government, in its wisdom, did not promise to avoid promulgating any more counterproductive economic policies that will force businesses and individuals to act in harmful ways. (In fact, government policy continues to coerce lending to unqualified individuals.) Rather, they passed massive new “financial reform” legislation aimed at preventing banks and other financial institutions from behaving logically in response to bad government policies. The cure for bad regulation is more bad regulation. And when the results of its own bad regulations created an opportunity to grab even more control over the marketplace, our government lept at the chance.

Similarly, having (probably inadvertently) made policies that resulted in a fatter, less healthy populace, our government is now poised to take advantage of that opportunity, to turn the purportedly grave danger posed to the nation by the obesity crisis into a mandate for assuming powerful controls over the prerogatives of individual Americans.

And now, having learned that, like bad economic policy, bad public health policy can get them to where they want to go, our Progressive leaders are turning their attention to the next great public health initiative. Far from apologizing to us for the damage they caused with their low-fat experiment, they are plotting the next great experiment in public health which they will perform upon the population.

It appears it will have to do with salt.

Podcast:

Major Victories In the War Against The Obese [ 18:18 ] Play Now | Play in Popup | Download (570)

DrRich has expended a fair amount of effort explaining to his readers why it is so critically important for Obamacare (and for the Progressive program in general) to conduct a vigorous war against the obese. For the benefit of readers who may be new to DrRich’s thinking on this subject, please note the proper emphasis: This is not a war against obesity, but against the obese.

A central tenet of this war is the assertion (sometimes overt, sometimes tacit) that the obese are fat by choice, that is, as a matter of willfulness and recalcitrance. Their unsightly adiposity is a condition of their own choosing, a direct result of their having settled upon gluttony and sloth as central  life-principles. It is because of their self-indulgence that the obese have allowed themselves to become a threat to humanity, and most especially, a threat to the fiscal stability of our healthcare system and therefore our nation. They have, by their own volition, made themselves fair game for whatever actions our Central Authority may deem necessary to protect the legitimate interests of the collective against their corrosive corpulence.

When we who are thinner (and purer) go along with, and even encourage, official actions against the freedoms of fat people, we will have allowed an important precedent to become established. It will be a precedent under which our ever-wise leaders may legitimately restrict, control and tax virtually any human behavior they can claim may lead to an increased risk of healthcare expenditures.

DrRich’s hypothesis is that the real point of this war is to set this very precedent. And hence, the actual war is against the obese, and not obesity.

Any hypothesis, of course, is useful only if it helps to explain certain interesting phenomena that otherwise would be difficult to explain. And this hypothesis (as do all of DrRich’s hypotheses) does just that.

For instance, consider several recent decisions the U.S. Food and Drug Administration has made removing from the market, or preventing from entering the market, certain drugs aimed at treating obesity.

Pharmaceutical companies, in recent years, have steered hundreds of millions of dollars toward the development of drugs for the treatment of obesity. They made these investments in confident reliance on a particular premise, a premise that has been explicitly and passionately expressed in a thousand ways by physicians, government agencies, beloved public figures, the popular media, academics, public health experts, and (chances are) yo’ mama.

The Obesity Premise

This, of course, is the Obesity Premise. According to the Obesity Premise we are now engaged in a great war against obesity. Obesity, this premise holds, is perhaps the greatest threat to the health of our nation. Obesity imparts tremendous risk to the individual by causing vascular dysfunction, hypertension and insulin resistance, leading to heart attacks, strokes, peripheral vascular disease, aortic aneurysms, kidney failure, arthritis, depression, disability, and death.

It has been asserted that it would be better to receive a diagnosis of many types of cancer than it would to be obese. It has been asserted, in well-organized public service campaigns that allowing oneself to become obese is the equivalent of committing suicide (again, emphasizing the central tenet that obesity is voluntary). Because the scourge of obesity is such a grave threat to individuals and to our society, the Obesity Premise concludes, extraordinary measures are justified in fighting it.

Accordingly, our drug companies have invested many years and vast amounts of money (time and money they could have invested in banishing wrinkles, say, or creating fine and durable erections upon demand), to develop drugs for treating obesity. They have invested in this way completely assured that their efforts, if reasonably successful, would be richly rewarded in the marketplace. Thus has been the promise of the Obesity Premise.

But today, drug company executives, if they are at all astute, must surely agree with DrRich that the great premise upon which their massive efforts have relied is, in fact, not actually operational. Not even close.

Consider what has befallen drug companies just in recent weeks when they relied on the Obesity Premise:

Item 1. The August 14, 2010 issue of Lancet published the obituary for the once-sure-blockbuster anti-obesity drug rimonabant (Sanofi-Aventis). Through years and years of development efforts, and through several clinical trials, rimonabant looked very promising. It proved effective not only in producing significant weight loss, but also in significantly aiding in smoking cessation, and in improving blood lipids. It won marketing approval in Europe, and was on the verge of being approved by the FDA. But in the end, the FDA declined to approve the drug – and in 2008 the Europeans withdrew it from the market – because of strong “signals” seen in clinical trials, indicating an excess of significant depression and even suicide* among patients taking rimonabant. As a result, Sanofi-Aventis abandoned all further development efforts for rimonabant.

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* The relationship between obesity and suicide is surprising and intriguing, but has received relatively little public attention. Because this relationship could possibly be useful to the Progressives in their war against the obese, DrRich may soon write a post to help them along in their efforts.
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The recent Lancet article on rimonabant describes the results of the once-anxiously-awaited CRESCENDO study, a study designed to evaluate rimonabant’s effect on long-term mortality and morbidity. The study was ended prematurely (when rimonabant was withdrawn from the market), so only 14 months of follow-up were able to be reported. Out of over 9000 patients randomized to rimonabant, there were 4 suicides, as compared to 1 suicide in the 9000 patients receiving placebo. An accompanying editorial laments that investigators were compelled to stop the study early, since the potential cardiovascular benefit that might have been realized from the impressive reduction in risk factors among patients taking rimonabant, given another year or two of follow-up, might well have outweighed the small (and statistically non-significant) increase in suicides. The editoralists go on to observe, “However, any mortality associated with cardiovascular preventive therapy is generally viewed as unacceptable. The preventive approach is fundamentally different from curative therapy for a potentially lethal illness.”

Item 2. In October, 2010, the FDA withdrew the weight-loss drug sibutramine (Meridia, Abbott) from the market, when the post-marketing SCOUT study showed a 16% increase in serious cardiovascular events in patients taking the drug. The FDA advisory panel was split as to whether the drug should be withdrawn, but the FDA concluded that the drug was too unsafe to remain on the market. (It was originally approved in 1997.)

What most in the general media failed to report, however, was that the SCOUT study specifically enrolled patients who had preexisting cardiovascular disease, and for whom sibutramine had never been approved in the first place. In other words, it was a study designed to test whether the usage of the drug could be safely expanded to fat patients who already had heart disease. An appropriate conclusion, from the SCOUT data, would have been that usage of the drug should not be expanded to those patients. There was no apparent objective reason to take the drug away from obese patients who had no preexisting cardiac disease, and who had had access to the drug for 13 years.

Item 3. Also in October, the FDA rejected approval for the obesity drug lorcaserin (Arena Pharmaceuticals). They rejected the drug because preclinical studies showed a “signal” for an increase in breast tumors in rats.

Item 4. Again in October (truly a landmark month for anti-obesity drugs), the FDA rejected approval, for the second time, of the anti-obesity drug Qnexa (a combination of phentermine and topiramate, developed by Vivus). The drug was rated as moderately effective for weight loss, but was rejected because of concerns about cognitive disorders, metabolic problems, increased heart rate, and (most especially) birth defects.

While these are truly legitimate concerns, topiramate (the component to which most of the concerns with Qnexa are due) has been widely used for seizures, and especially for migraine headaches. While the FDA expressed special concern over the possibility of birth defects if topiramate were used in obese women of childbearing age, most migraine sufferers who take the drug are women of childbearing age.

What is the best explanation for these recent FDA decisions?

Please understand, Dear Reader, that DrRich is not necessarily saying that the FDA was flat-out wrong in rendering these decisions on any of these four anti-obesity drugs. All of these drugs posed at least the possibility of serious side effects in at least some patients, and none produced more than moderate average weight loss (though, to be sure, individual patients achieved remarkable results with each of these drugs).

Rather, DrRich is saying that the FDA’s decisions in each of these four cases were inconsistent with the Obestiy Premise, and therefore that the Obesity Premise is operationally false. That is, when it comes to actually taking action, the Central Authority entirely discounts the Obesity Premise.

The severely obese, in point of fact, do indeed have a remarkably elevated risk of developing premature, severe, disabling, expensive and lethal medical problems. Many of these individuals, in truth, would indeed be better off having many types of cancer. This aspect of the Obesity Premise is scientifically correct.*

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*There is much less evidence that people who are only moderately overweight – the vast majority of Americans said to be in grave danger due to their weight – are at markedly elevated risk because of weight alone. Indeed, DrRich has discussed evidence for the “Obesity Paradox,” whereby those who are moderately overweight appear to have improved survival compared to those of low or normal weight.
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So, at least for people who are very obese, a drug that produced weight loss but carried a small risk of potentially dangerous side effects might be justifiable, just as a treatment for cancer or heart disease might be justifiable despite a risk of serious side effects.  But this is clearly not how the authorities are treating weight loss drugs. It appears plain that in order for an obesity drug to be approved, that drug will have to display virtually no side effects. Operationally, therefore, obesity is treated as a low-risk medical condition whose treatment does not warrant any measurable risk. Indeed, obese patients are not to be allowed even the option of choosing such a drug, even after being fully informed of the potential risks and benefits.

If the Obesity Premise were operational, the authorities would have permitted studies with rimonabant – by far the most promising anti-obesity drug yet developed – to continue, in order to measure whether the long-term benefits of weight loss, smoking cessation, and lipid control outweighed what now appears to be a very small risk of excess suicide – a risk which could almost certainly be reduced even further with appropriate psychiatric screening.

If the Obesity Premise were operational, the authorities would not have withdrawn sibutramine from healthy obese patients (who had had access to the drug for over a decade) on the basis of a study which evaluated the drug in people with serious pre-existing cardiac conditions, and for whom the drug had never been approved.

If the Obesity Premise were operational, the authorities would not have banned lorcaserin for the sole reason of a tumor signal of uncertain significance seen in rats.

And if the Obesity Premise were operational, the authorities would not have denied topiramate to obese patients, when they allow the widespread use of the same drug in patients with migraines.

Undeniably, the actions of the Central Authority (as opposed to its words) entirely discount the Obesity Premise. Its actions reveal that the Obesity Premise is for public consumption – that is, for propaganda – only, and that its main purpose is to justify extraordinary measures.

The actions of the Central Authority do, on the other hand, comport with DrRich’s hypothesis – that we’re fighting a war against the obese, and not against obesity. In a war against the obese, a cure for obesity would preclude the need for strong central controls, and so would be counterproductive.

Therefore, while it goes about whipping our population into a frenzy about the scourge of obesity, the Central Authority is simultaneously doing whatever it can to stifle novel therapies that begin to attack obesity. True, none of these four drugs “cures” obesity, and none is risk-free. But the cure for any significant medical problem rarely occurs in a single step, or is accomplished without the possibility of side effects.

The Central Authority has sent a very clear message to the pharmaceutical industry: “When it comes to treating obesity, only perfection will be allowed; we insist on remarkable efficacy, and virtually no side effects. Without such a result all your efforts will come to nought.”

DrRich believes that in the last month the drug industry has heard this message loud and clear, and that it will be a very long time indeed before any more investments are made toward developing drugs to treat obesity.

By the same actions, the Central Authority has also sent a very clear message to the obese: “Do not expect any help from medical science, you self-indulgent, lazy, gluttonous budget-busters, you wreckers of society, you fattys. You did this to yourselves, by your own willful actions, and by your own actions have brought the rest of us to the brink. You deserve no more quarter than other sociopaths who undermine civil society – the bank robbers, the child snatchers, the Tea Party marchers. Because your individual choices have brought you to this juncture, prepare to be constrained in your individual choices.”

And so, in just the past few weeks, the war against the obese has seen significant victories, and has advanced ever closer to its ultimate goal.

Podcast:

Progressive Medical Ethics [ 11:56 ] Play Now | Play in Popup | Download (560)

Having advanced his theory of Progressivism, and having shown how his theory explains certain behaviors on the part of Progressives that otherwise might be difficult to explain, DrRich now proposes to examine the question of the medical ethics of Progressivism.

This ought to be an important question to doctors, patients, and anyone who thinks they might someday become a patient. For, however else one might want to define “ethics,” for practical purposes a system of ethics fundamentally determines how one ought to act when one must act in the face of competing interests. And the healthcare system being rife with competing interests, ethical guidance is critical as we determine who is to get what, when and how.

Because ethicists generally attempt to devise a solution which balances, to some degree, the various competing interests (which all tend to have at least some merit), the field of ethics has become very complex to the uninitiated. Indeed, the arguments ethicists use to justify their positions are frequently so difficult to follow that professional ethicists all too often have been reduced to a virtual priesthood, dispensing their lofty wisdom from on-high.

But since truly ethical behavior requires more than merely following handed-down marching orders, and indeed, requires a certain amount of clarity as regards ethical precepts, DrRich has always considered the arcane work-product being offered up by most modern ethicists to be, well, unethical.

And this is where Progressivism, for all its faults, provides a breath of fresh air. For the chief ethical precept of Progressivism is an item of exquisite clarity, a bright, shining beacon that cuts through all the fog and fuzziness, and points the way.

To review, Progressivism (in DrRich’s formulation, at least) is the idea that the driving imperative of mankind is to devise the perfect society, that, indeed, the desired “progress” in Progressivism is the steady advancement toward that perfect society. The Progressive program is the natural result of the belief, most famously espoused by Aristotle, that man is inherently a social animal, an animal that naturally forms into complex societies; that individual men and women do not have much intrinsic worth as stand-alone units, but only as components of their larger group.

Furthermore, the Progressive program is to be driven by an intellectual elite, who will determine what does and does not advance the perfect society. This requirement for an elite leadership also derives from Aristotle, who recognized that most individuals within a society are incapable of perceiving the greater good, and if left to their own devices would return mankind to the ranks of the apes.

The Progressive program of steadily advancing toward a perfect society is much more than merely a desirable goal, it is an imperative; it is intrinsic to humanity itself. All other programs (libertarianism, conservatism, religions which emphasize the importance of individual salvation, &c.) are not only counterproductive to man’s true imperative, but are heretical.

And so Progressive ethics, if nothing else, are crystal clear: Anything that advances the Progressive program is ethical; anything that hinders it is unethical.

This general statement of ethics immediately implies two corollaries that more directly define what “right behavior” will look like:

Corollary 1) What is best for the collective is best for the individual. That is, since individual humans only achieve their humanity as a part of the greater whole, it follows that the chief obligation of any individual within a society is to act for the good of the collective.

Corollary 2) Since what is best for the collective is determined by the intellectual elite, it is the obligation of all individuals in a society to follow that elite.

With this summary of Progressive ethics, let us now turn to the question of medical ethics.

Classical medical ethics, from the time of Hippocrates, required the physician to always use his/her special training and special capacity for autonomous action for the benefit of the individual patient, and to place the needs of the individual patient above their personal needs. This requirement is what defined medicine as a classical profession.*

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* While the term “profession” has become diluted to include streetwalkers and football players, classically “the professions” were limited to physicians, lawyers and clergy, precisely because of this definition.
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But classical medical ethics cannot be permitted under a Progressive program. Allowing (much less encouraging) physicians to act autonomously for the good of their individual patients will necessarily conflict with that which is best for the collective. This is true because if the needs of the individual were to prevail, then patients who are lucky, smart or rich, and who have doctors who are particularly clever or aggressive, will get more than their fair share of the healthcare resources, leaving the collective wanting.

Accordingly, after years and years of dogged work, the Progressive agenda has succeeded very recently in changing the formal definition of medical ethics. In early 2002, a “new charter” of medical ethics was published in the Annals of Internal Medicine. This new charter has since been formally endorsed by every major medical professional organization in the world. It charges physicians with the ethical obligation of achieving a fair distribution of healthcare resources. Medical students worldwide are now being taught that their main ethical obligation is to work for distributive justice, their obligation to work for the optimal benefit of their individual patients is a secondary concern, because of Corollary 1.

DrRich has described elsewhere how this new medical ethics places patients in great jeopardy, and wrecks medicine as a true profession. But old farts like DrRich (who prefers to think of himself as a “classic” physician), who still care about such things, will be gone in a few decades and can be safely ignored.

(For those who are interested, DrRich had the opportunity earlier this year to engage representatives of the American College of Physicians – chief authors of the New Ethics – in a public debate over medical ethics in this very space. DrRich was, at the end of the day, brushed off by the ACP, but not before eliciting a response from the Chair of the ACP’s Committee on Ethics, Professionalism, and Human Rights. That response, in essence, was, “What is good for the collective is good for the individual, and any jack-dog knows this. Who the hell are you?” In other words she invoked Corollary 1. You can read all the details about the great Medical Ethics Smack Down in this series of articles.)

One might ask, what was the impetus for physicians to voluntarily change their time-honored ethical precepts?

They were coerced.

Significant coercion was being applied to doctors to place the interests of the third party payers – both insurance companies and the government – ahead of their duty to individual patients. The utter impotence of physicians in fighting off this coercion was the impetus for promulgating the new ethical precept (to society) in the first place. This fact was stated explicitly in a 1998 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. . .,” and which called for a “new ethic” which was more consistent with how doctors were being forced to behave. Specifically, the proposed “new ethic” was a duty to the group.

This paper was an important impetus to formally changing professional ethics. When the new ethical standard istelf was finally published in 2002, its very first sentence began, “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.”

In other words, physicians felt powerless to fight off the coercion – so in response they changed medical ethics to make it OK to cave in.

And to say it yet another way, physicians can now act under Corollary 2 with a clear conscience.

Accordingly, it is now become the physician’s ethical obligation – and not merely a legal or regulatory obligation – to follow to the letter the guidelines, processes, and procedures that are handed down to them from various government-established expert panels, when they are caring for their patients. Autonomous actions taken on behalf of individual patients is more than just discouraged, it is, simply, wrong.

Under our new program of medical ethics, then, doctors are absolved of much of the responsibility of clinical decision-making. As many of those decisions as possible – a continually increasing quantity of them as time goes by – will be determined centrally, at which point the doctor is ethically obligated to follow them.

DrRich continues to think this new program is harmful to patients and to the medical profession. He will bring up some specific issues in this regard in future posts.

DrRich has said many times that clinical science is among the least exact of the sciences, and therefore, the results of clinical research are particularly susceptible to “spinning” by various interested parties, in order to yield the kind of results they would prefer to see.

Until recent times in American medicine, the parties who have been most interested in spinning clinical research have been the people who run drug companies and medical device companies (who need clinical research which supports the use of their products), and the medical specialists (who are more likely to be paid for performing medical procedures that are supported by clinical research). In writing about such data-spinning abuses, DrRich has particularly targeted his own Cardiology Guild, but only because he knows and loves cardiologists the best. He suspects that other specialists are doing exactly the same thing.

While DrRich has used reasonably gentle humor (laced, to be sure, with sarcasm and irony) to criticize doctors and their industry collaborators for twisting clinical data to their own ends, others have expressed the same concerns in much more indignant terms, and have threatened to employ professional sanctions, civil and criminal penalties, and everlasting perdition, to curtail such behaviors.

(Indeed, DrRich has always suspected that the real reason President Obama has not closed Guantanamo is so he has someplace to send recalcitrant American physicians who persist in accepting logo-ed plastic pens from drug reps, or who refuse to accept reduced Medicare/Medicaid reimbursement schedules, or who engage in the black market healthcare activities the President surely understands he is provoking. The one thing that can torpedo Obamacare completely is if American doctors refuse to go along, and any physician who shows signs of doing so will have to be dealt with harshly – if not by detention in exile, then by some other method.)

There is nothing wrong with a little old-fashioned American Puritanism, of course, and physicians and companies who behave badly ought to be punished. But DrRich begs his readers to understand that the inevitable bias in clinical research is not one-sided; it cuts both ways. And clearing the field, so that the only entities which are left to spin clinical research data will be the government-controlled expert panels, is a very bad idea.

DrRich must remind his readers that Obamacare provides for several distinguished expert panels, to be appointed by the executive branch of the federal government, to direct the studies, interpret the results, and apply the results to official reimbursement policies, of a species of clinical research which is called “comparative effectiveness research.”

Comparative effectiveness research comes in two flavors. First, there is the comparative effectiveness research whose unambiguous goal is to compare the clinical effectiveness among different treatment options, so as to offer physicians objective guidance in making the clinical decisions whose results are more likely to be clinically favorable to their patients. This kind of comparative effectiveness research is an unalloyed good, and it is as unassailable as babies and bunnies. Then there is Comparative Effectiveness Research (CER), which is to be operated by new government bureaucracies, whose agenda regarding what kind of effectiveness is actually to be compared is intentionally ambiguous, but which at the end of the day will be comparing cost effectiveness, as opposed to clinical effectiveness, so that doctors will make the clinical decisions whose results will be more favorable to healthcare cost containment.

Our policymakers have been studiously ambiguous about what they mean by  Comparative Effectiveness Research.

This ambiguity was made clear during the Obamacare debates when Peter Orszag testified on behalf of the administration before the Senate Finance Committee. When queried by skeptical Republicans on the ultimate goal of the proposed CER boards, Mr. Orszag was evasive. Specifically, when asked by Senator Kyle (R-Arizona) whether the CER board would be empowered to make decisions regarding which medical services will be reimbursed, Mr. Orszag finally replied, “Not at this point,” a reply which did not alleviate the suspicions of the minority party.

To state the ambiguity more plainly, it is clear that while the government’s CER panels will mainly be concerned about comparing cost effectiveness, the only kind of effectiveness they are willing to discuss publicly is clinical effectiveness. This studied ambiguity allows proponents of Obamacare to paint opponents of the CER panels as being against the “babies and bunnies” form of comparative effectiveness research, and thus reveal those nay-sayers as being beneath contempt, and unworthy of anyone’s attention. Meanwhile they will be free to advance their real “cost effectiveness” agenda.

Therein, of course, lies the government’s bias regarding clinical research. Since clinical research is the primary mechanism by which Obamacare proposes to cut the cost of healthcare, and since the new government panels provide the chief mechanism for controlling and applying the results of that clinical research, the government will be strongly biased toward research results that point toward the less expensive of the two treatments that are being compared.

The idea that government-controlled expert panels will be unbiased, of course, is so absurd that nobody can plausibly believe it. Where you go wrong, dear reader, is in believing that their bias can only take them so far; that clinical research, being science, will more or less yield the Truth; that while a biased party might shade things a bit in this direction or that, at the end of the day the answer which is reached will approximate the Answer.

In fact, clinical research is inherently biased, from the moment a research study is conceived. And those who conceive of, plan, conduct, and analyze the clinical study have every advantage. (This, indeed, is the very reason why everyone is so indignant about the studies conducted by medical industry and their minions in the medical academy.) That advantage is now, under law, defaulting to the government panels.

To be sure, many clinical researchers believe in their hearts and souls that bias can be eliminated through the use of randomized clinical trials (RCTs). In such trials, “like” groups of research subjects are divided randomly into two or more groups, and each group receives (for instance) a different therapy, whereupon differences in outcomes among the groups are attributed to the different therapies to which they were randomized. Indeed, the widespread belief that RCTs are the necessary and sufficient means to achieve “clinical truth” has become so deeply ingrained within the medical establishment that when anyone (such as DrRich) says otherwise, he immediately reveal himself as a scientific Neanderthal.

DrRich has previously observed that the widespread belief in RCTs has become like a Cult, whose creed can be reduced to three main tenets:

1) Data derived from randomized clinical trials represents Truth.
2) Data derived from non-randomized trials represents Falsity.
3) If you don’t believe this, you are a heathen.

Objective observers will find it at least a little ironic that an attempt to claim the scientific high ground has so obviously resulted in a new religion, replete with its own dogma.

The sad truth is that the results of RCTs are invariably dependent on the bias built into their design, and even if internally they are statistically legitimate, they can often send us down the wrong path.

Those who design RCTs (the smart ones, at least) know this. Like smart trial attorneys, they know the answer before they ever dare to ask the question. So they tailor their “question” in such a way as to yield the answer they want to get. Indeed, if a lawyer should end up asking a question in court that produces an unexpected answer, he or she is completely incompetent and ought to be sued for legal malpractice. In more cases than one might think, the same is true for those who design RCTs.

So, for instance, if you are a payer and want to limit the use of an expensive therapy, you design your RCT so that enrolled patients likely to respond to the therapy are diluted with a broad population of enrolled patients, many of whom are less likely to respond to the therapy, to assure that the average response of the whole population will be quite small. (In many instances the clinical characteristics of the likely responders and the likely non-responders will be reasonably apparent.)

On the other hand, if you are a company that wants to encourage the use of your expensive new product, you design an RCT that preferentially enrolls the relatively small subset of patients who are very likely to respond favorably, and then trust the marketplace (with a tweak from your DTC advertisements) to “extrapolate” the results to broader categories of individuals.

So RCTs do not eliminate statistical bias, as the dogma suggests. Rather, they simply offer an opportunity to control the statistical bias in your favor. Since most doctors (and most regulators, guideline writers, and reporters) don’t seem to get this, it becomes relatively easy to fool them.

What DrRich is saying, with regard to the government panels that will direct and interpret the CER (panels that will determine who gets what, when and how, and who gets paid for it and who doesn’t), is that even if those CER panels were not overtly biased against high-cost medical care, eliminating bias from their clinical research would be impossible. And given that the CER panels are being created expressly for the purpose of reducing high-cost medical care, the bias will likely become extravagant. But since that extravagant bias will be couched within the results of various RCTs, the Cult of Randomization will be invoked as “proof” that this expensive medical treatment is no better than that cheaper one.

DrRich has illustrated numerous times how the results of RCTs can be twisted and spun by interested parties, whether by private or government interests, to achieve the results one wants. The CER panels will (it seems obvious) become masterful at doing this.

The apparently widespread notion that industry-sponsored research is invariably biased, while government-sponsored research is entirely objective – and that therefore, the only thing we need to assure accurate clinical research is to have it all controlled by the government – is astoundingly naive.

DrRich believes that, since we cannot possibly eliminate bias from clinical research, we are more likely to approach the actual Truth if we: a) encourage clinical research by all parties – the government and private entities – so that, at least, we may be more likely to engender a “balance” of results; and b) insist that all clinical research be conducted with complete transparency, so that not only are the results made available to anyone who wants them, but also a complete accounting of all the other aspects of the research – including the study design, conduct of the study, and the analysis of the data.

Since bias cannot be eliminated from CER even if the federal CER panels wanted to (and they decidedly will not want to), then insisting on complete and total transparency (ideally, even to the point of making the raw data itself accessible), will be our chief defense. DrRich assumes, since covert rationing will undoubtedly be the CER board’s main, though unspoken, agenda, that such transparency will not be forthcoming without a fight.

Transparency will be worth fighting for, however. At least some bias in clinical research is unavoidable, so complete transparency is our best defense against the biased application of the results of clinical research, whether it is conducted by companies or CER panels.

Podcast:

Don't Sweat the Obesity Dividend [ 9:36 ] Play Now | Play in Popup | Download (371)

DrRich has pointed out several times that it is very important to our new healthcare system, as a matter of principle, to be able to discriminate against the obese.

The obese are being carefully groomed as a prototype, as a group whose characteristics (ostensibly, their lack of self-discipline, or their sloth, or their selfishness, or whatever other characteristics we can attribute to them to explain how their unsightly enormity differentiates them from us), will justify “special treatment” in order to serve the overriding good of the whole.

The obese are a useful target for two reasons. First, their sins against humanity are painfully obvious just by looking at them, so it is impossible for them to escape public scorn by blending in to the population, unlike some less obvious sinners such as (say) closet smokers, or pedophiles. And second, since true morbid obesity almost always has a strong genetic component, successfully demonizing the obese eventually will open the door to the demonization of individuals with any one of a host of other genetically mediated medical conditions.

Readers who wonder why this is a big deal need to go back and study the original Progressives, for whom some form of genetic purification was an indispensable step toward achieving societal perfection. This was true not only for notorious eugenicists such as Woodrow Wilson, H. G. Wells, George Bernard Shaw, and Margaret Sanger, but also for the kinder, gentler Progressives we generally revere even today, such as Theodore Roosevelt, Winston Churchill, and even Mohandas Gandhi.

This sort of thinking fell out of vogue, for obvious reasons, after World War II. So it is no longer cool to talk openly about genetic cleansing.

But discriminating against people who have genetic health disorders (in the name of achieving an optimally efficient healthcare system for the purpose of cost saving) would be a start. And the obese have been selected as the most acceptable prototype for such treatment.

In this light, a recent article in the Public Library of Science Medicine Journal has created something of a problem for the anti-obesity movement. This article compared the lifetime cost of healthcare (beginning at age 20) for obese individuals and for smokers to the lifetime cost for non-smokers who maintained a healthy weight. Naturally, the study concludes that the healthy individuals can expect to live longer than the obese and the smokers (84 years vs. 80 and 77 years, respectively). However, the healthy young people will consume $400,000 in lifetime healthcare costs, vs. only $365,000 for fat people and $321,000 for smokers. (The cost savings in the obese and the smokers arise from their relatively premature deaths.) Therefore, healthy people, over their lifetime, are a bigger drain on the healthcare system than the obese and the smokers.

The reason this study presents a problem  is that it appears to contradict a central axiom of our present program. Specifically, it places in some peril our deeply held conviction that the obesity epidemic is one of the major threats to the stability of our healthcare system.

The added costs which the obesity epidemic poses to our healthcare system has become a touchstone, to the extent that it has become acceptable even in polite circles to openly discriminate against, if not overtly disdain and humiliate, the obese. Mississippi is considering legislation to prevent the obese from eating in restaurants. And in Britain, whose healthcare system has been held up as a model for Americans, doctors themselves are saying that obese patients should be barred from receiving medical services. (Though, in defense of his physician colleagues, DrRich wishes to point out that these same medical humanitarians are also calling for the withholding of medical care from the elderly and smokers – so perhaps they are not being unusually unkind to the fat.)

In light of this, what are we to do with this new study which says that obesity saves money for the healthcare system? Do we reverse course, and embrace this “obesity dividend?” Do we encourage supersizing, and, far from refusing to serve them, offer the overweight free second portions? Do we give them deeply discounted heavy-duty suspensions? Better yet, do we give away free Marlboro starter packs to the fat? (Just think how much money we’d save with obese smokers.)

Thankfully, no.

DrRich has pointed out innumerable times the absurdities we find ourselves promoting when the chief purpose of the healthcare system becomes avoiding costs rather than maximizing health, that is, when its chief job is covert rationing. It is therefore gratifying to say that this is one of those cases where we don’t have to engage in such absurdities. Let’s be plain about it: We don’t need to reevaluate our current vilification of obesity (and smoking) just because people who have these conditions may save us money in the long term.

The reason? We don’t care about the long term.

Who cares that, in 50 or 60 years, today’s healthy 20-year-olds are going to cost us a lot of money? They’re likely to be entirely free to our healthcare system for at least several decades. In contrast, today’s obese and today’s smokers, what with their chronic diabetes, heart disease, kidney disease, joint replacements, strokes, lung disease, &c., are costing us a lot of money right now.

If we actually cared about the long term, we’d be doing something about the Social Security and Medicare entitlements we’ve already signed up for, which in a little more than 20 years will require confiscating more than 50% of each American paycheck, just in payroll deductions. (Never mind income tax.) Heck, just looking at their pay stubs will probably cause most of today’s healthy 20-year-olds to die of apoplexy by the time they’re 40. In any case, the entitlements we’re obligated to provide will threaten societal disintegration long before today’s healthy young adults ever need elder care. Consoling yourself with the idea of projected long-term savings when you’re facing such a fiscal catastrophe is like consoling yourself with the idea of beautiful spring alpine flowers when you’re directly in the path of an onrushing avalanche. Projected long-term savings are completely irrelevant.

The obesity dividend is just smoke, and can be safely ignored. For the greater good of our social welfare, we’re far better off doing what we’re doing today – castigating and humiliating the obese into right actions, and if that fails, then (following the example provided by the British healthcare system which Dr. Berwick and others urge us to use as a model) discriminating against them when they need healthcare. Once we’ve established this useful prototype, we can apply it to whatever additional groups we can identify as targets of our collective indignation.

Whatever it takes to avoid confronting the rationing issue head on.