In a recent post, DrRich described the Regulatory Speed Trap, and alleged that our leaders (long before the Obama administration came along) have learned to use it to intimidate and control selected citizens and institutions when it is to their advantage to do so.

The Regulatory Speed Trap, readers will recall, involves the sudden and arbitrary “reinterpretation” of various confusing, ambiguous, or impracticable regulations which have been on the books for some time, and for which affected citizens and institutions (out of sheer necessity) have established de facto interpretations so that they can continue to function. By their longstanding acquiescence with these de facto interpretations, the Central Authority has at least tacitly endorsed them, and thus commerce is permitted to continue. Until, that is, the time arrives when it behooves the Central Authority to suddenly reinterpret those tangled regulations, and convert selected law-abiding citizens into criminals. By the selective enforcement of ambiguous laws, of course, the goals of Social Justice can be advanced.

As a public service, as a warning to academic medical centers, and as a heads-up to the Central Authority (which DrRich has found in personal encounters to be very scary, and to which he would very much like to endear himself against any future encounters) he will now describe a very serviceable but potentially forgotten Regulatory Speed Trap which was laid more than 15 years ago, and which is ripe for springing.

During the decade of the 1990s, DrRich was chairman of the Institutional Review Board (IRB) in a major teaching hospital. The IRB is the committee that reviews all proposed human research projects in the institution, and assures that the research meets ethical and legal standards as set forth by the Office of Human Research Protections (OHRP) of the HHS, and that the rights and welfare of the human research subjects are protected. The IRB has the duty and the authority to prevent or shut down any research project which is not meeting expected standards. The IRB, unlike any other committee within a hospital, reports directly to the Feds, in order to limit any local influence that may be brought to bear over its decisions by hospital administration, well-endowed researchers, or any other local big wigs.

If the Feds decide that an institution’s IRB is not assuring compliance with all the rules, regulations, guidelines, &c., in all their particulars, then they can arbitrarily and indefinitely terminate all human research in that institution, until such time that sufficient corrections, and sufficient penance, can be made – a process that is typically measured in years. This kind of research “death penalty” – which can ruin an academic institution – has been dealt out more than once.  The prospect is a dreadful one to any academic medical center.

It was, in fact, in his capacity as IRB chair that DrRich first became reasonably adept at reading and interpreting the kinds of obtuse regulations and guidelines commonly promulgated by our government. The official documents under which an IRB must operate are many, lengthy, and often difficult to interpret with absolute surety. Yet, in order for the IRB to function, these regulations and guidelines must be resolved into concrete meanings, which, under scrutiny, would most likely prove acceptable to the Feds. (A difficult task to be sure, but still, not markedly different from the task faced by anyone who wishes to conduct an activity for which the government has devised regulations.)

In any case, readers will understand why it was with some dismay that, in 1994, DrRich received this letter from the OHRP, announcing a new policy regarding diversity in human research.

Now to be sure, such a new policy was needed, since up to that time medical research evaluating new therapies was overwhelmingly performed on adult white males. However, this distribution of the benefits (and risks) of research was not in place because of prejudice against (or in favor of) women or non-whites. Rather, it was there for good and practical reasons. Ever since the thalidomide fiasco, it was verboten to enroll women who might become pregnant (i.e., any woman of childbearing age) in most kinds of clinical research. And African-Americans were understandably and appropriately distrustful of medical researchers ever since the Tuskegee study, and as a group they assiduously avoided participating in clinical research. So the exclusion of these groups was made, for the most part, either out of the desire to protect certain classes of individuals (such as unborn babies), or out of the desire of certain groups of individuals to protect themselves.

Still, DrRich was very sympathetic to efforts to find ways of safely extending research on new products to excluded groups. Otherwise, how could we learn if new medical products were safe and effective in everybody? So he read the letter from the OHRP with interest.

And he was immediately dismayed. While the government’s new policy of diversity in clinical research was advanced for the best of intentions,  the substance of the policy was impracticable past the point of absurdity.

The new policy on diversity in clinical research, in its essentials, stipulated:

1) All minorities and all genders MUST be included in all clinical research studies.
2) Sufficient numbers of subjects MUST be enrolled to allow valid outcome statistics to be performed for each category of participant.
3) Cost is NOT allowed as an acceptable reason not to enroll the stipulated groups in sufficient numbers.

The letter and its supporting documents defined six racial and ethnic categories that must be included: Hispanic or Latino, American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, Black or African American, or White.

The letter and its supporting documents defined the three genders that must be included as: Male, Female, Indeterminate or Transgender.

Because each defined subgroup must be included in each study in sufficient numbers to allow for valid outcome statistics to be computed, the new directive seemed to require each research trial to expand its size by 18-fold (to account for six racial/ethic categories, and three genders). So a study which would normally require the randomization of 1,000 patients to achieve statistical surety would now need to enroll 18,000 patients. Notably, the recruiting effort that would be needed to comply with this new policy would be far more than merely 18 times more difficult. For it is one thing to find an “extra” 17,000 people who are willing to risk their health for the sake of medical science, but quite another to find these altruists in just the right distribution, including, for instance, 1,000 indeterminately-sexed Pacific Islanders.

But no matter. The new policy explicitly stipulated that the expense of such a recruiting effort was not a permissible excuse for failing to enroll the proper distribution of subjects.

After carefully examining the letterhead of this document to make sure it did not come from The Onion, DrRich made some well-placed, but gentle and appropriately circumspect, inquiries in an attempt to determine whether he was reading it correctly. How seriously must one take this astounding new federal policy on diversity in research? He quickly learned he needed to stop asking questions. His sources revealed to him that several of the authorities in question actually considered their new directive to be a bit mild – a little too watered-down.

For instance, limiting the number of racial and ethnic categories to only six had been a major concession to practicality. Some of the interest groups that had been instrumental in constructing this new policy apparently had argued, for instance, that each of the 337 federally-recognized American Indian tribes ought to be called out as distinct groups. And the authors had thoughtfully compressed the number of genders to only three (when clearly there are at least four). So the people responsible for this new policy had already carefully considered the issue of practicality, and had mercifully compromised in order to render this policy as reasonable as the principles of research diversity would allow.

So yes, the Central Authority was deadly serious.

As it happened, at this very time DrRich was lodged in the teeth of another Regulatory Speed Trap (which he has described elsewhere), so he took this new OHRP policy very seriously. He knew that while it could not be complied with in all its detail, it also could not be ignored. So he called a special meeting of the IRB to discuss how to respond to the new policy.

A long meeting was held in which this new policy was introduced to the membership, and the members’ reactions were permitted to move through the necessary stages of mirth, horror, disbelief, resignation, and finally, resolution. When sober discussion was finally possible, the members unanimously agreed that encouraging the enrollment of women and minorities in clinical research was an important and laudable goal. We also agreed that if researchers were made to comply with the letter of this new policy, all clinical research in the U.S. would come to an immediate halt. And for this reason, we concluded, it must be true that the policy actually desired by the OHRP must be different from what appeared to be the letter of this policy.

We therefore composed a formal response to this policy, which we placed into the minutes of the meeting, for posterity, and for the benefit of whichever future government agents might burst through the doors with automatic weapons, in order to conduct unspecified investigations. That response went something like this:

Medical research aimed at reducing mortality and limiting pain and suffering is a great boon to mankind, and as long as it is conducted ethically it should be encouraged in every way. Diversity in research is also an important good, and to the extent it is practicable, individuals from all races and genders should be offered an opportunity to participate in clinical research. In deciding which of these laudable goals takes precedence, we note that while research can continue despite imperfect diversity, it will not continue if perfect diversity is an absolute requirement – in which case, one ends up with no research, and no diversity. Such a result, we hold, cannot possibly be the aim of the OHRP.  It therefore seems apparent to the committee that the intent of the diversity policy recently handed down by the OHRP must necessarily be to optimize diversity to the fullest extent practicable, and not to stifle research altogether in service to impossible diversity goals. We therefore interpret this new policy to indicate that all practical efforts must be made to recruit research subjects from all racial and ethnic groups, and from whichever genders we can find, and we will hold researchers in this institution to that policy.

And that’s just what we did.

Our formal interpretation of the OHRP’s diversity policy, it must be admitted, did not follow what certainly appears to be the letter of the policy. But it does work toward the stated intent of the policy, and it has the not-inconsiderable advantages of: a) being actually feasible to implement, and b) allowing medical research to continue. In general, DrRich has found that regulators are somewhat more inclined to look upon your behavior as being relatively benign, if you are able to demonstrate that you have taken their regulations seriously (no matter how absurd they might be) instead of simply disregarding them. Accordingly, our IRB created a record demonstrating that we explicitly acknowledged the new policy, we made a good-faith effort to interpret it in light of universally-recognized truths, and then we acted in accordance with that reasonable interpretation.

DrRich does not know how all the other IRBs in the U.S. responded to this new diversity policy. However, since no institution has stopped doing research on its account, and since no institution has launched massive programs to seek out the tens of thousands of transgender Alaskan Natives that would be required in order to conduct medical research under such a policy, one can only conclude that all those other IRBs also decided not to follow the new diversity policy to the letter. DrRich does not know how many of them took the trouble to make a formal record of their interpretation of that policy, and of their rationale justifying their subsequent behavior. In any case, by the studied inaction of the Central Authority, those interpretations have been allowed to stand for well over a decade, and medical research has proceeded accordingly.

DrRich left the practice of medicine – and the wonderful world of IRBs – at the turn of the millennium. He has no idea how big a deal the issue of “diversity in research” is these days. But to the best of his knowledge the OHRP policy has never been rescinded. Indeed, DrRich finds it extremely unlikely that, at any time during that interval, it would have been politically feasible for any government agency, under any Administration, to soften this or any existing formal policy on diversity.

Most likely, after 17 years, this Regulatory Speed Trap is still set, and waiting to be sprung.

As it happens, the Central Authority today is desperately looking for ways to stifle medical progress, since medical advances are among the chief drivers of increased medical spending. The 1994 diversity policy, whose clear-cut plain-English language is being so universally ignored by medical researchers in every American institution, would seem to offer a fine opportunity for shutting down some of that research.

This Regulatory Speed Trap is not only set and baited, but is swarming with potential victims. Fair warning.

From all appearances, Republican voters are desperate for New Jersey Governor Chris Christie to throw his hat into the ring, and announce that he’s running for the Republican nomination for President. And, while the governor has made dozens of absolutely definitive statements utterly denying that he is going to run, he nonetheless seems quite happy to continue relentlessly teasing his supporters with the possibility. (Just the other night he gave a speech at the Reagan Library in which he discussed foreign policy and other topics not notably relevant to running his state. What’s up with that?)

There are several good reasons Governor Christie gives for not running. He promised the voters of New Jersey that he would stay in office and do everything he could to fix the fiscal disaster that his predecessors created there. He notes that he doesn’t have the fire in the belly which, apparently, one must have for this sort of contest. He does not have very much experience with governance, and has said repeatedly he does not feel ready to become the leader of the free world.

None of these reasons, of course, are dispositive, and all of them could be dispensed with very quickly. Governor Christie is pissing off so many people in New Jersey so quickly that it is not inconceivable that, if he asked them politely, the majority would soon give him a pass on all his promises, and bid him Godspeed in his new endeavors. Fires in the belly, it is said, come and go, and one might just show up at any time. And as for feeling ready to become the leader of the free world, well, the bar there has been lowered so much in the past couple of years that even DrRich – who balked at the responsibility of becoming secretary of his book club – would no longer be intimidated at the prospect. I mean, what the heck?

And so, despite all his denials and all the reasons he gives for staying out, it remains entirely possible that Governor Christie may still get in the race.

DrRich is alarmed by this possibility. And so should we all be, as Governor Christie’s potential candidacy poses a very great threat to us all.

You see, dear reader, the governor is just too damned fat.

Our leaders have just spent nearly three years demonizing the obese, and convincing we the people that fat people, by virtue of their unsightly and self-induced rotundity, are a grave threat to the well-being of each of us.

Here is what we have been taught: Aside from the obvious negative characteristics of fat people (their sloth, gluttony, laziness, selfishness, &c.), and the fact that they are unpleasant to behold and inconvenient to encounter (they are slow, they take up too much space in the grocery aisles and on buses, and they sweat more than you and me), and the fact that obesity is contagious so that fat people should be isolated and shunned, and the fact that the obese probably account for global warming, and thus will ultimately be responsible for untold death and destruction; aside from all these undeniable truths, the obese consume far more than their rightful allotment of healthcare resources, which, per force, leaves much less healthcare available to us holier persons. They are, in fact, trying to kill us.

Demonizing the obese is critically important to the program we have embarked upon in America. Obamacare may give the Central Authority the legal standing to control the personal behaviors and personal choices of individual Americans, but it does not give them the moral authority to do so, nor the ability to actually enforce that control. Americans, despite 50 years of indoctrination to the contrary, still value their individualism, and will still balk – or worse – when they perceive their personal freedoms are being taken away.

The obese are supplying our leaders the vehicle they need for breaking down this last barrier. For, if everyone can agree that obesity is evil, and so are the people who allow themselves to become fat (despite all the “help” they get from expensive public service announcements, calorie counts posted in restaurants, and lectures from First Ladies), then how can we object when our leaders are forced to take stronger measures to “encourage” better behavior, or, if necessary, to punish their behavior?

By virtue of their now-universally-accepted state of sinfulness, the obese are fair game for whatever actions the Central Authority deems necessary to cause them to either lose weight or pay for their sins. From appearances, such measures are likely to begin with taxing soft drinks and Twinkies and whatever other foodstuffs the experts (in their wisdom) deem to be illegitimate sources of calories. But really, the sky’s the limit. For instance, under the undeniable proposition that it costs more energy to move a fat person from point A to point B, whatever the mode of transportation, the obese could be subjected to a special carbon tax, based on their BMI. The periodic mandatory “weigh-ins” such a tax would require would serve the useful purpose of public humiliation, an important incentive to weight loss.

Further humiliations could be visited upon the fat by designating special isolated areas in the workplace (ideally, an area fully exposed to the elements) for fat people to consume their calories. This latter strategy, of course, is derived from the same restrictions placed on smokers, and can be legitimized by the same sort of logic. That is, the authorities can invoke the prospect of second-hand obesity* to induce fear and loathing of the fat, and cause them to become socially isolated.
______
*The “scientific” conclusion that obesity is contagious, i.e., that those who associate with the obese are more likely to become obese themselves, has been proffered by academics employing the same kind of statistical legerdemain used to blame global warming on fat people. Clearly, obesity has now become so toxic to the survival of mankind that any paper submitted to a medical journal which offers some new reason to despise the fat – no matter how absurd – will be cheerfully accepted by the editors, and published with great fanfare.
______

It goes almost without saying that the ultimate censure would simply be to withhold healthcare services from fat people. This is a strategy that is already being employed by the British healthcare system,  a system we are urged by many of our leaders, such as Dr. Berwick, to employ as a model.

The great benefit of taking the demonization of the obese to its logical conclusion, of course, is that by doing so, the Central Authority will have established the very important precedent of selectively enforcing certain rules, based on a person’s behavioral habits*, in order to achieve Social Justice.

_____
*While demonizing the obese is considered legitimate by many because fat people “choose” to become fat through their selfish behavior, it is nonetheless true that becoming truly obese (as opposed to becoming merely overweight) is almost always strongly mediated by genetic and metabolic factors. Blessed with the same genes and metabolisms, many of us svelter, more holy individuals would also have become fatties.
____

This is a truly critical precedent to set. This precedent will ultimately allow our Central Authorities to restrict, control and tax virtually any human behavior they can claim may lead to an increased risk of healthcare expenditures. Such behaviors may include (in addition to obvious things like smoking and alcohol consumption), one’s choice of occupation, participation in sports, hobbies, hours spent or miles traveled on the highways, and how well you follow the lifestyle changes prescribed by your PCP in your annual, very-strongly-encouraged, “free” wellness checks. Indeed, it is difficult to conceive of any choice one makes in daily living that does not, in some manner, impact on one’s likelihood of requiring medical services, and which thus would not be subject to central control.

All this will become possible because Americans are willing to accede to the demonization of their obese neighbors.

So now we see why Governor Christie must not run. Think of the damage he could do!

The prospect of a fat man campaigning for President – an endeavor which everyone admits takes an incredible amount of initiative, intelligence, energy, and a robust constitution – would itself undermine important “truths” about fat people upon which we base much of our (hard won) hatred of them. Worse yet, if Governor Christie actually managed to secure the Republican nomination, there’s an excellent chance that a majority of voters would actually cast their ballots for him! And he might actually become President!

What would that say about the general acceptability of obese people in our society?

Governor Christie’s candidacy would do untold damage to the critically important obesity paradigm which our leaders have painstakingly established over the past few years, and thus, would seriously damage their entire program.

And it is for this reason that Governor Christie must not run.

Note: DrRich now realizes that he has made a major mistake by writing this post, and here offers an apology and a weak explanation for his error.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

____

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

____

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

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

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

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

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

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

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

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

If we are ever to gain control of our healthcare spending, which is a necessity if we are going to avoid an economic catastrophe during the next couple of decades, we have to come to some agreement, as a society, on a few essential questions.  Chief among these questions is whether healthcare is something we must consider to be a right for all Americans.

The question of whether healthcare is a right has become a very contentious one. One side passionately declares that of course it is a right, as healthcare is so critically important that how could it be otherwise? And the other side, with equal conviction, asserts that nothing can be a right that creates an involuntary burden on another.

That is, advocates on either side of the argument maintain their respective positions as being axiomatic, as primary and irreducible truths – which does not allow much room for discussion or debate. So instead of dispassionate discussion, we get vituperation. For, when one’s opponent denies an axiomatic truth, he declares himself to be beneath contempt, and unworthy of any degree of respect.

Regular readers will know that DrRich is a peacemaker.  Accordingly, he will attempt an apology for each of these mutually exclusive, fundamentally principled positions. He will follow this by a description of the pragmatic (as opposed to principled) position on the matter taken by our current leaders. Then finally, humble as ever, he will offer the “real” answer to the question of whether healthcare is a right.

The Conservative Position

Conservatives (and in most matters, DrRich is among this lot) think of “rights” in terms of “natural rights,” that is, in terms of rights which accrue to every person by virtue of the fact that they are members of the human race. Natural rights are generally considered to descend from the Creator (as the Declaration of Independence explicitly says), or at the very least from the inherent nature of the universe, and thus are not subject to addition or subtraction by any human authority – such as by governments.

Because natural rights are granted equally to every human, it follows that there is no such thing as a right that imposes obligations or limitations on the natural rights of others.

A right to healthcare would most certainly require an abridgement of the rights of others, and so there can be no right to healthcare.

The Progressive Position

Most Progressives do not explicitly deny the existence of natural rights, because doing so would cause them embarrassment when they assert their own inherent and unalterable “truths” (such as the superiority of “diversity” over all other human virtues). However, at their core Progressives do not (and cannot) actually subscribe to natural rights, since the Progressive program virtually requires a Central Authority to assign and distribute and enforce various differential “rights” to various groups, in order to achieve social justice.  And achieving social justice is the central requirement for Progressives to reach their ultimate goal of a perfect society.

To Progressives, creating healthcare equality among all Americans is critical to social justice. And so, it becomes axiomatic for them that healthcare must be a right.

It becomes immediately evident that any such “rights” granted under the Progressive program will necessarily create involuntary obligations upon at least some individuals. So it is likewise immediately evident that any “right” for Progressives will fundamentally violate the essence of a “right” for Conservatives.

This impasse, which occurs at the very first step of the discussion, is what prevents Conservatives and Progressives from engaging in any fruitful discussion of whether healthcare ought to be a right.

The Practical Position (The BOSS Rule)

Our current leaders have taken a more practical position on the question of a right to healthcare. They rely on the fact that “rights” are often bequeathed not because of some overarching principle (as with Conservative or Progressive thought), but rather, because of issues of practicality – or more straightforwardly, because the sovereign authority has the desire and the power to do so. They point out that throughout human history innumerable “rights” have been promulgated by the expediency of raw power.

We need only consider, during the course of human events, such widely acknowledged rights as the exceptional rights of the aristocracy (especially the divine rights of kings), the unique rights of the clergy, or the special rights of the Politburo (or the Congress).  The fact is that all of these rights clearly imposed more-or-less oppressive obligations on, and limited the individual rights of, the people. But that is not the least matter of concern. Rights become rights because the exigent authority has the desire to create them, and the capacity to exert violence wherever necessary to enforce them.

In this light, one might say that healthcare is a right in America simply because of the BOSS rule (Because Obama Says So). If Obama says healthcare is a right (and he has said so, many times), and has the raw power to back it up, then, by God, healthcare is a right.

The Correct Position

It is easy to see why the “healthcare is a right” debate has become so contentious – people mean entirely different things when they use the word “right.” A right to a Conservative is a natural phenomenon, awarded equally to all people and fundamentally unalterable by human hands. A right to a Progressive is an essential social construct, enumerated by enlightened leaders, which is necessary to further the principle of social justice. And to some non-ideologues a right is whatever the sovereign authority says it is.

To DrRich, none of these constructs are useful to solving our current problem of healthcare spending.

The Conservative position – that because healthcare cannot possibly be a natural right, therefore there is no right to healthcare – not only seems callous to a large segment of Americans, but (as DrRich will shortly demonstrate) is wrong. The Progressive and Practical positions – that healthcare is a right either because it is necessary to further the supreme cause of social justice, or simply because the Central Authority decrees it to be so – leave us in an untenable position when it comes to reducing healthcare spending.

That untenable position occurs because, when a “right to healthcare” is bestowed by the government, under either the Progressive program or the BOSS rule, that right is open-ended. It immediately takes on the characteristics of an entitlement, a grant bestowed on individuals by society because of the group to which they have been assigned (such as: citizens, residents, people over 65 years of age, a particular racial or ethnic group, etc.) That entitlement is to “healthcare” – that is, for whatever we can get the authorities (by whatever political maneuvering we choose to engage) to agree that “healthcare” includes, whether it is well-baby checks, artificial hearts, chemotherapy, extravagant end-of-life care, hair transplants, or cosmetic surgery. A right like this – an entitlement – is rarely taken away, or even limited, once granted. Entitlements are soon seen by their recipients (and by the vested interests that quickly spring up to defend those entitlements, such as the bureaucracy that regulates them, the companies that supply the products for them, and the healthcare professionals that administer them) as something that is owed forever, as a natural, God-given right, which can always be expanded, but never ever restricted.

DrRich, therefore, finds all these positions on a right to healthcare to be unhelpful. For this reason DrRich proposes a new position on a right to healthcare, a position which he humbly calls the Correct Position.

To wit: all Americans have an implied contractual right to healthcare. We have this right because we have long since entered into a contract under which, in exchange for implied considerations, we’re all paying for it.

Under the present healthcare system, a system we have devised over the past six decades through our duly elected representatives, every person living in the United States is sharing in the cost of healthcare for every person who receives healthcare. Since every American, in one or more ways, is paying for the healthcare of every American who receives it, every American has a just claim – a contractual right – to their fair share of that healthcare.

Let us list some of the ways in which Americans all share in the cost of all healthcare:

1) Anyone receiving a paycheck is subject to payroll deductions to pay for Medicare for the elderly and Medicaid for the poor.
2) Anyone paying income tax is paying higher tax rates to offset tax-deductible health insurance premiums purchased by businesses for their employees. (That is, employer-provided health insurance is subsidized by the taxpayer.)
3) Anyone buying products in the U.S. is paying higher prices to cover the healthcare costs of American businesses.
4) Anyone living in America is sharing in the massive societal burden we are creating by allowing healthcare spending to be passed off to future generations, by way of the national debt.

These costs, and more, are borne by everybody living in the U.S. And since all Americans are paying the cost of all healthcare – even the cost of so-called “private” health insurance – we all have a right, in the form a consideration under a contract, to claim some of that healthcare for ourselves. To deny this fact would void the contract.

It is important to note that this argument for a right to healthcare is fundamentally different from the arguments typically given. This contractual right is not “granted” to an individual by a beneficent society because of some inherent characteristic of the recipient, but rather, it exists solely because the individual is party to a social contract, created by the peoples’ representatives, under which healthcare is a consideration given in return for certain obligations the individual makes to society. Those obligations would include paying for the publicly-funded healthcare through taxes, and subjecting oneself to whatever limits to publicly-funded healthcare such a system requires in order to maintain societal integrity.

It is critical to understand that this kind of contractual right to healthcare enables us, legally end ethically, to set necessary limits on what we mean by healthcare. The “right” to healthcare is a contractual right, and not a natural right or an ethical requirement.  So, under that contract,  as in any contract between consenting parties, we have a duty to specify the limits of our mutual obligations, that is, to specify what we mean by “healthcare.” Furthermore, we have a duty to specify what we mean by “healthcare” in such a way that fulfilling the contract does not bring about national bankruptcy or otherwise cause societal destruction.

There would no longer be an obligation to provide individuals with every manner of available healthcare under all circumstances, but only to provide individuals with that level of healthcare which is provided as a public benefit to all other individuals, under the terms of the social contract. (An entitlement to healthcare, in contrast, traditionally is an open-ended promise in which “healthcare” comprises anything and everything one might think has any possibility of restoring every bit of health.)

To summarize, as DrRich sees it we have already created a contractual obligation to provide publicly-funded healthcare to all individuals, by virtue of the fact that we have burdened every individual in America with the cost of healthcare for anyone who is now receiving it. In contrast to the Conservative position, DrRich’s formulation recognizes a right that truly exists, by virtue of a contract that is unarguably in force, and that has been enacted over a long period of time through the offices of the people’s elected representatives. And unlike the Progressive position, DrRich’s formulation does not entrap us into an open-ended obligation to pay for all “healthcare,” however our collective sentiments may entice us to define that term.

We might as well own up to our responsibilities by openly recognizing : a) the universally-shared payments we all make to the cost of American healthcare: b) the right of all Americans to the considerations that arise from this universally-shared burden; and c) that it is right and proper for us to establish clear limits to the obligations borne by all the parties, as we must do with any legitimate contract.

The open recognition of this contractual right to healthcare will finally give us the framework we need for a public discussion on setting necessary limits on publicly-subsidized healthcare spending.

And this, DrRich most humbly submits, is the correct answer to whether healthcare is a right.

DrRich considers it his responsibility to point out to his readers certain truths related to modern American healthcare which may not be obvious to everyone, and which the fine people in the mainstream press choose not to mention.

Be honest. If it weren’t for DrRich, would you be aware that the only reason Obamacare became the law of the land is that the private insurance companies needed it in order to have any hope of long term survival?  Would you understand that the Progressive healthcare system to which we are now legally committed inherently requires all of the following things (while loudly proclaiming the opposite): ending the classic doctor-patient relationship; preventing individuals from spending their own money on their own healthcare; killing off the practice of primary care medicine; to the furthest extent possible, limiting preventive medicine; and stifling medical innovation?

One thinks not.

And so, DrRich hopes you will pay attention as he reveals yet another poorly-appreciated truth about our new healthcare system. Namely, it has become the case that maintaining your own wellness is not merely something which would be desirable, something you ought to do, or at least something you ought to want to do. It is now your duty.

You owe it to society to maintain your wellness, to take every step at your disposal to keep yourself from needing to consume healthcare resources. You owe it because healthcare is now a collective responsibility. And if your chosen actions (or inactions) cause you to become unwell, and if your unwellness causes you to consume healthcare resources which otherwise might have been available to individuals who (unlike yourself) became ill through no fault of their own, and if such faultless individuals subsequently suffered or died as a consequence of your failure to honor your duty, well then – that would make you no different from any other common criminal whose selfish actions produce harm to their innocent victims.

Maintaining your wellness is not a nice-to-have; it is your non-negotiable obligation.

You have been told that your wellness is very important to the caring people who will run our new healthcare system. And indeed, it is. So you will, by law, be “entitled” to annual, detailed “wellness checks,” provided by a dedicated team of healthcare workers, who will assess (and record) your efforts to maintain your own wellness, and then will give you all the instruction you need to alter whatever suboptimal behaviors you are displaying. The results of these annual wellness checks will be entered into a federally-approved universal electronic medical record, so that any healthcare provider, anywhere, at any time, will have a complete record of the trajectory of your state of wellness over the years – and of the degree of your compliance with the instructions you have received for maintaining that wellness.

Of course, if you elect to forgo the annual wellness checks to which you are entitled, that information (i.e. that you cared so little for your wellness that you couldn’t be bothered to do anything about it) will also be maintained in the universal electronic records.

Then, when you become ill 10 or 20 years from now, your records can be consulted to decide to what extent your illness can be considered self-induced. For, when resources are scarce, the only moral thing to do is to distribute them according to who is the most deserving.

Most readers are now thinking that DrRich is paranoid. Guilty as charged. However, DrRich’s paranoia, regarding the kinds of behaviors of which our Central Authority is capable, is based on hard experience. Indeed, it is evidence-based.

Still, DrRich is enough of a realist to understand that it is unreasonable to ask his readers to just trust him here. Instead, let’s examine patterns of behavior, regarding supposedly self-induced disease, which our society is already displaying. The best example, one which DrRich has written about extensively, is obesity.

We are witnessing a sustained and ongoing campaign to demonize the obese. Consider: While we are universally urged to stifle any impulsive speech or sentiments which, by any stretch of the daintiest of sensibilities, might make any member of any group (however you choose to define a group) the least bit uncomfortable, it is perfectly OK to castigate the obese, loudly and often. We can say about the obese anything we like.  Screw their feelings. It is perfectly fine to insist that it is the obese – gluttonous, lazy, self-indulgent, slothful fat people – who are driving our healthcare spending off a cliff. It is acceptable to publish ridiculously flawed papers in respected scientific journals proving that global warming is caused by the obese (thus pinning upon them the responsibility for upcoming catastrophes of unimagined proportions), and demonstrating that obesity is a contagious disease (which will justify any actions we may choose to take to concentrate the obese into special camps).

A person’s choice to allow themselves to get fat already justifies more than mere words of castigation. Under the British Health Service (the model to which Dr. Berwick and other of our current healthcare heroes openly aspire), the obese (along with smokers, another group of selfish sub-humans who use an unfair share of healthcare) are now being removed from the waiting lists for medical services.* By virtue of their obesity (and the lack of social responsibility their obesity indicates), fat people have forfeited their equal access to healthcare.

___
*Removing the fat from the waiting lists has at least two beneficial effects. It punishes them, of course, for their selfish refusal to maintain their own wellness. But it also reduces the long waiting lists that exist in Britain for medical services, closer to the target waiting times which the government has been promising its citizens for decades.
___

Demonizing the obese has many advantages. Chief among these is that the obese are easy to spot. In contrast to the Jews of Nazi Germany, one does not have to sew a Star of David to their jackets to know which individuals are wrecking the culture. By just walking down the street (not that fat people do all that much walking, lazy SOBs) they reveal themselves, by their unsightly corpulence, to be one of those people who are ruining the healthcare system for the rest of us. And we svelter, more worthy citizens can look upon them with the scorn they deserve.

Especially now that we have so many programs and policies aimed at preventing obesity – putting apple slices in Happy Meals, publishing calorie counts in restaurants, being lectured at by First Ladies and skinny movie stars, &c., – anyone who still chooses to remain obese despite all this abundant assistance must be especially contemptible.

Perhaps most useful of all, in the long run, is the fact that real, honest-to-goodness, health-threatening obesity almost always has a strong genetic component. When we learn to demonize the obese, we are learning that wellness is a duty even if your genes (or some other force that is largely beyond your control) mitigates against it.

The obese, therefore, are the perfect target. Thanks to them, we are teaching ourselves that it is right and proper to disdain individuals who are leading less than exemplary lives.

Once we have learned this lesson well, it should be relatively easy for us to apply the same kind of disdain to others who who fail to honor their duty to maintain their own wellness. Most of these scurrilous individuals will not be so obvious to spot as fat people.  But at the end of the day, they will reveal themselves in the ultimate manner – they eventually will fall sick. And by their diseases we shall know them.

For the past several years, our healthcare experts have been busy declaring more and more illnesses to be “preventable.” And if an illness is preventable, and an individual fails to prevent it – well, what more do you need? That person has obviously failed to perform their sacred duty to society, and has forfeited any claim to the healthcare we more deserving people can expect.

The list of illnesses which are officially preventable now includes coronary artery disease, heart failure, kidney failure, diabetes, stroke and many kinds of cancer. And just a week or two ago, Alzheimer’s disease was added to the list.

It is possible that in a decade or so, if you acquire an illness from this growing list of “preventable” medical disorders – especially if your annual wellness checks reveal that you have gained weight since college, or you habitually fail to exercise at least 90 minutes per day, or that you imbibe less than one or greater than two alcoholic beverages per day – you may be triaged to Tier B healthcare. Tier A will be reserved for people who obviously care more than you do about wellness, and about their duty to society. Just as obesity does today, the state of your health will demonstrate your true commitment to the perfect society to which we all aspire.

For, when it is your duty to maintain wellness, your illness reveals a grave dereliction.

The recent announcement that President Obama would dispatch “secret shoppers” – agents of the government posing as patients with either private insurance or Medicare/Medicaid, who would call primary care physicians’ offices to document how long it takes to receive appointments – had many PCPs quite upset.

PCPs were upset despite the fact that the administration assured them that the President’s spies were only aiming to help. In particular, the secret shoppers were going to document that America has a PCP shortage, presumably so that government programs of some sort could be devised to fix that shortage. (They would also document, bye the bye, that patients with government insurance have a more difficult time getting appointments with PCPs.) Apparently, however, the outcry from insulted PCPs was so great that the administration quickly decided to scrap the secret shoppers program – for now, at least.

It is obvious that what the administration claimed they wanted to measure is already well known. Yes, there is indeed a PCP shortage. And yes, PCPs (being, on average, intelligent persons) are relatively slow to schedule patients whose insurance is known to result in a financial loss – if they schedule them at all.

Therefore, equally obviously, there must be some other motive for the administration to have devised this secret shopper program.

The real motive, DrRich submits, was to establish with actual data that: a) we have a two-tiered healthcare system, in which patients on government insurance plans sometimes have more difficulty obtaining medical care, and b) doctors (even the universally-beloved PCPs) are greedy and untrustworthy. Such results, with expert handling, would have served to move some American citizens a little closer to accepting a single-payer healthcare system. It would also serve to convince a few people that, seeing as how physicians behave so badly, perhaps it is not really necessary to have a doctor as your PCP.

All in all, the secret shopper program would have been a few hundred thousand dollars well-spent.

Still, DrRich can only shake his head in wonderment that his PCP friends expressed such great dismay over such a small thing as the secret shopper program. It is as if, after the Titanic struck the iceberg, a delegation of passengers was dispatched to berate the Captain because the turn-down service seemed slow that night.

How is it possible for PCPs to be so indignant about such a trivial thing as secret shoppers, when the very means of their livelihood – their chosen career – is at an end? For it is plain to anyone who cares to look that primary care medicine as we know it is dead. It lingered for years in a moribund condition, and its obituary was finally published last year in the Obamacare legislation.

Primary care’s cause of death was a culmination of two fatal disorders. Firstly, the healthcare system itself – well before the Obama administration came along – slowly smothered primary care into oblivion.

Consider the reduced condition to which the healthcare system – especially the government payers – eventually drove the primary care doctor: Their pay is determined arbitrarily by Acts of Congress, like workers in the old Soviet collectives. They are directed to “practice medicine” strictly according to directives (quaintly called “guidelines”), handed down from on high by panels of sanctioned experts, and accordingly PCPs are enjoined from taking into account their professional experience, or their specific knowledge of their individual patients. They are limited to 7.5 minutes per patient “encounter,” and the content of this brief encounter is determined by sundry Pay for Performance checklists, so as to strictly limit any interactions with their patients that do not meet the approved agenda. Their every move must be carefully documented according to incomprehensible rules, on innumerable forms and documents, that confound patient care but that greatly further the convenience of the stone-witted bureaucrats who are employed specifically to second-guess every clinical decision and every action they take. Worst of all PCPs have been charged with being the primary mediators of covert, bedside healthcare rationing, and to this end have been pressed to nullify the classic doctor-patient relationship by the healthcare bureaucracy that determines their professional viability, by the United States Supreme Court*, and by the bankrupt, new-age ethical precepts of their own profession.

____
*Pegram et al. vs Herdrich(98-1940), 530 US211 (2000)
____

By such insults, even before Obamacare became the law of the land, primary care medicine had been reduced to one of the most frustrating, enervating and demeaning endeavors a physician could imagine.  Many if not most practicing PCPs are looking to either retire early or change careers, and medical students – even the most idealistic ones – are avoiding primary care in droves, especially if their training exposes them to the palpable despair radiated by actual primary care physicians.

But the second fatal disorder has nothing to do with policy or politics. Even if doctors had perfect control of the healthcare system and the political realities, primary care medicine (as we know it) would still be in trouble. This is because of an axiomatic truth revealed by the annals of human progress, to wit: As knowledge increases and technology improves, activities that used to require the services of highly-trained experts become available to non-experts who have much less training. A lot of what PCPs have traditionally done – check-ups of well patients, screening for occult disease, controlling cholesterol, advising on diet, weight loss and exercise, managing routine hypertension and diabetes – really can be reduced to a series of guidelines and checklists, which can be adequately followed by individuals with much less training than these doctors receive.

When any area of expertise evolves to this level, it is inevitable (in a free economy) that lesser-trained individuals will inherit it. This event greatly increases productivity, makes the services in question more readily available to many people at lower cost, and (ideally) frees up the experts to take on more challenging endeavors. While this kind of transition is nearly inevitable, it is often painful and disruptive. The pain and disruption are being experienced by PCPs today.

DrRich agrees with fellow blogger Wade Kartchner that primary care medicine has advanced to the point where it really would make sense to turn over many of the routine, mundane, and reducible-to-checklist tasks that PCPs typically perform to non-physicians. PCPs who are fighting against this inevitability are wasting their time and energy. They are fighting both history and the laws of economics, so in the end it is a losing battle. It is time for PCPs to move on.

It is of course immaterial whether you agree with DrRich on this point. It is immaterial because this is how the Central Authority sees it.

Having painstakingly reduced you PCPs to tools of the state – whose chief job is to follow the guidelines and place chits on the checklists, &c. – it is only natural for the Central Authority to eventually notice that you really don’t need all that training to do the kind of job they have invented for you. Nurses – who can be “trained up” much more rapidly than you, who will work for much less money than you, and who (they think) will be much less recalcitrant about following handed-down directives than you – will fill the gap. And you, doctor, can go pound salt.

So it was really only a formality for the Obamacare legislation to make the death of primary care official. And the new law, accordingly, did so by stating explicitly that PCPs and nurse practitioners are now equivalent, one and the same. They are both PCPs under the eyes of the law. The actual language of the obituary is as follows:

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

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

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

What this means is that today there are two pathways to becoming a PCP. You can spend four years in college, four years in medical school and three years in a clinical residency – or you can go to nursing school and do another year or two of clinical training. Given this established fact, one could hardly fault patients for questioning the common sense (if not the intelligence) of a healthcare worker who, at this point in the history of medicine, would choose the former pathway.

And so the issue is decided. PCPs: by virtue of your specialty you have been formally (and legally) reduced to the status of a nurse-equivalent. Your specialty, as you have known it, is dead.

Among other things, this means that the secret shopper gambit – when it is finally implemented – is just not worth worrying about. It’s only a way to convince a few more Americans that their PCPs are essentially worthless, and that they’d be just as well off having a nurse practitioner do the job. So don’t sweat the secret shoppers. Forget them.

Instead, you need to decide what you’re going to do about the demise of your chosen career.

In his next post, DrRich offers you some friendly advice in this regard.

Q: What’s the difference between a public health expert and an ax murderer?

A: Actually, there are two differences. The public health expert usually means well. And the public health expert has only metaphorical blood on his hands.

In a prior post DrRich related how public health experts, displaying every ounce of the overblown self-confidence traditionally enjoyed by the expert class operating within our Progressive institutions, have wreaked all manner of harm upon our society with their premature promotion of Low-Fat Diets, an action which, DrRich argued, is at least partly responsible for triggering our current epidemic of obesity (and therefore, according to some respected experts, global warming).

As if causing the rotundity of the American populace (and again, with less certainty, the impending destruction of our planet) was not enough, it is now beginning to appear as if another major public health initiative, an initiative with which we have all been pummeled mercilessly for over two decades, also may be based upon a faulty premise.

DrRich speaks, of course, of the long crusade which the experts have preached, and which we among the faithful have doggedly waged, against cholesterol. While nobody is talking about it, it is beginning to appear (to DrRich, at least) as if the fundamental hypothesis underlying our long war on cholesterol is far less solid than we have been assured.

DrRich is moved to describe his uneasiness with the cholesterol hypothesis at this time because, last week, yet another nail was driven into its coffin.

The Cholesterol Hypothesis

Our war on cholesterol is based on the cholesterol hypothesis, which states that an elevated cholesterol blood level is a major cause of atherosclerosis, and therefore of heart attacks, strokes and peripheral artery disease. The hypothesis goes on to describe two major species of blood cholesterol – LDL cholesterol, or “bad” cholesterol, which increases cardiovascular risk; and HDL cholesterol, or “good” cholesterol, which reduces cardiovascular risk.

According to the cholesterol hypothesis, the LDL cholesterol molecules deliver excess cholesterol to the lining of the arteries, where it gradually accumulates, leading to the buildup of the plaques that obstruct blood flow. HDL cholesterol represents cholesterol that has been removed from those plaques (so the higher the HDL level, the more cholesterol is being removed)

Therefore, it behooves every American to work assiduously to reduce our LDL cholesterol levels and increase our HDL cholesterol levels.

This, of course, has become more than merely a suggestion or recommendation. Under our new incipient universal healthcare paradigm, in which your suboptimal health habits directly affect the healthcare services which will be available to me, your failure to control your cholesterol and your subsequent utilization of precious healthcare resources amounts to attempted murder, and is therefore a grave crime against humanity.

The cholesterol hypothesis is based upon two observations gleaned from clinical research. First, that high LDL cholesterol levels are significantly associated with the risk of heart attack, &c. (and that high HDL cholesterol levels are associated with reduced risk); and second, that lowering LDL cholesterol levels (or increasing HDL cholesterol levels) with drug therapy lowers that risk.

It was this second observation that “clinched” the cholesterol hypothesis for the public health experts (and most doctors).  And this second observation is based virtually entirely on the statin drugs. Until the statin drugs were first developed – drugs that powerfully and reliably reduce cholesterol levels – it had never been convincingly demonstrated that lowering cholesterol levels actually did any good.

And so, according to the cholesterol hypothesis, every American is obligated to work to maintain “healthy” cholesterol levels. In general, we are urged to begin with diet and exercise, and if that does not work (and depending on the level of our cardiovascular risk) we are likely expected to begin on drug therapy.

But DrRich suggests (reluctantly, since by doing so he undoubtedly invites even more personal attacks against his intellect, honesty, personal appearance, parentage, &c.), that the cholesterol hypothesis may not be correct.

Evidence Against the Cholesterol Hypothesis

1) Despite several clinical trials showing that the kinds of lifestyle modifications which are officially  recommended for the reduction of cholesterol can in fact reduce LDL cholesterol levels, it has not been shown that such lifestyle-induced cholesterol reductions lead to improved clinical outcomes.

2) Early (pre-statin) cholesterol-lowering trials (using clofibrate, cholestyramine, and gemfibrozil) were unable to demonstrate that an improvement in cardiovascular mortality accompanies a reduction in cholesterol levels, and indeed, each of these studies showed an unexpected increase in non-cardiovascular mortality with the cholesterol-lowering drugs.

3) More recently, studies showed that adding the powerful non-statin cholesterol-lowering drug ezetimibe  to a statin drug not only failed to improve outcomes, but also (unexpectedly) may have led to more plaque growth than was seen with the statin alone. (Ezetimibe is marketed as Vytorin in those god-awful commercials comparing your Aunt Helen to a strawberry cheesecake.)

4) Just last week, the NIH prematurely halted a high-profile study (the AIM-HIGH trial) comparing statin to statin + niacin in patients with cardiovascular disease and low HDL levels. (This study was designed to show that increasing HDL levels with niacin would improve outcomes.)  The study was stopped 18 months ahead of schedule not only because it was determined to be extremely unlikely that the increase in HDL produced by niacin would improve outcomes, but also because of an unexpected increase in strokes among the patients receiving niacin.

5) Numerous trials using statin drugs have demonstrated that these drugs can reduce cardiovascular events and improve cardiovascular mortality – without an increase in non-cardiovascular mortality – in patients who have known heart disease or who are at increased risk for heart disease. However, the mechanism by which statins provide these benefits may have little or nothing to do with their cholesterol-lowering effects. (Statins have several mechanisms of action under which they can improve cardiovascular outcomes, including stabilizing plaques, improving endothelial function, reducing intravascular blood clotting, and reducing inflammation. Each of these mechanisms can directly and immediately reduce the risk of heart attack and stroke – more directly and immediately, one must concede, than by merely reducing cholesterol levels.) So, for instance, when statins are administered during acute coronary syndromes, their benefits are seen immediately – an effect not explained by the cholesterol hypothesis.  Further, the JUPITER trial showed convincingly that statins can improve outcomes even in patients with “normal” cholesterol levels, which is also not explained by the cholesterol hypothesis.

In summary, lowering cholesterol by any method other than statins has not been shown to significantly improve outcomes.  And evidence indicates that the chief benefit of statins may be imparted by the drugs’ non-cholesterol-lowering mechanisms.

These observations suggest an alternate hypothesis.

The Bear Shit Hypothesis

If you are walking in the woods and you see bear droppings, your chances of being eaten by a bear are much higher than if there were no bear droppings. But if you take out your (legally registered) firearm and shoot the bear droppings, you have not improved your risk at all.

DrRich maintains that the totality of the data regarding cholesterol, as it exists today, is entirely consistent with the bear droppings hypothesis.  That is, elevated cholesterol levels may (and certainly do) indicate a higher risk of cardiovascular disease, but may not themselves be a causative factor.

Indeed, the bear shit hypothesis can explain the facts as we know them much better than the traditional cholesterol hypothesis. The bear droppings hypothesis can explain why treating cholesterol with any of several methods (aside from statins) fails to improve risk.  (While cholesterol is associated with atherosclerosis, it may not be a critical cause of atherosclerosis.)  Since discharging one’s firearm at bear droppings might awaken a sleeping bear, the bear droppings theory is also consistent with the fact that reducing cholesterol with virtually any drug save one of the statins may actually worsen outcomes (by creating sundry “unexpected” medical problems of one variety or another).

That is, unless you are using statins (which have several important therapeutic effects unrelated to reducing cholesterol, and which in high risk patients far outweigh – statistically speaking – any side effects these drugs have), treating cholesterol levels with drugs may turn out to be a bad idea.

The Bear Shit Hypothesis, being merely an hypothesis, may not be correct, either. But it seems to fit the existing clinical evidence at least as well as – and DrRich suggests, better than – the cholesterol hypothesis. And at least DrRich admits his hypothesis may not hold up at the end of the day, and does not insist that all his fellow citizens drop what they are doing and rearrange their entire lives to comport with its implications.

Where Does This Leave Public Health Experts?

For over 20 years, the cholesterol hypothesis has been presented to the public, with all the evangelical fervor employed by the global warming experts, as settled science.  There is clearly some muttering going on these days amongst the experts – in their private conclaves – about certain “anomalies” that have appeared in the clinical database over the past decade or so, anomalies which have muddied the nice, clear cholesterol hypothesis they have so forcefully promulgated for so many years. They are desperately trying to explain away these anomalies by subdividing LDL and HDL cholesterol into more and more complex “subspecies” that have “counter-intuitive” behaviors. (This latter effort has the benefit of being so mind-numbingly complex that nobody can follow it – which means that it is difficult to assert with any authority that it’s all folderal.)

In the meantime, because statins are effective at reducing cardiovascular mortality and morbidity, and because statins also (quite possibly as an unrelated side-effect) reduce cholesterol levels, the experts can continue to trumpet their cholesterol hypothesis to an unsuspecting public, with the caveat that statins ought to be the drug therapy which one should try first. They have not yet reached the point where they are willing to say that if statins are not tolerated, one should probably not attempt to reduce cholesterol levels with any of the non-statin drugs (i.e., with drugs that merely reduce cholesterol).

And so, for the second time we see that a massive public health campaign that has been whipped up by the expert class is likely to turn out to be a wrong-headed “experiment,” one which so far has been conducted on the entire population for more than two decades.  This time (and in distinction to the low-fat diet “experiment”) it appears that little widespread harm has been done. But this result is fortuitous, and is most likely related to the fact that statin drugs turn out to help prevent the rupture of atherosclerotic plaques by means apparently unrelated to their cholesterol-lowering abilities.

What will the experts do if the cholesterol hypothesis finally is proved to be mistaken? It is easy to predict. They will stick tenaciously to their cholesterol hypothesis until the last possible minute, then if and when they at last find it to be utterly unsupportable, they will simply move on to the next hypothesis as if the old one never existed.

For one thing we know with certainty about the expert class is that they are never chastened. Their low-fat diet dogma simply and smoothly elides into a Mediterranean diet mantra (a diet, as it happens, with plenty of fats). Their demands that “safe” trans fats be substituted for saturated fats in processed foods simply transforms, 10 years later,  into indignant demands that the trans fats be removed when it is discovered they are worse than saturated fats. The phrase “global warming” is simply dropped in favor of “climate change” when it is discovered that the planet actually has been cooling since the 1990s.  In no case is there an acknowledgement that their prior expert pronouncements have been both arbitrary and wrong, and much less is there ever an apology. Being experts, and thus by definition correct, they never, ever have anything to apologize for. They simply abandon the old dogma as needed, and seamlessly adopt the new one.

For when you’re an expert within our multiplicity of institutions for public improvement, history will always have begun 10 minutes ago.

In response to DrRich’s recent post on good debt vs. bad debt, Liz writes:

Is the survival of the individual, after consuming healthcare, necessarily neutral to our national economic health? On the one hand, if an individual is saved from death by consuming healthcare and goes on to be very productive in life, then that healthcare would have been a good investment. On the other hand, if someone else is saved by doctors, only to go on to require more and more medical care without contributing anything to the collective, then the individual’s survival has a negative impact on the nation’s economic health. . . . Some people will argue that keeping people healthy is a good investment for our country.

This comment was triggered by DrRich’s premise (modeled after Alexander Hamilton) that for the federal government to acquire certain kinds of debt – say, borrowing money to build a new hydroelectric plant that will supply electricity to a large region of the country and thus enable sustained economic expansion – is truly a positive investment for future generations, and is thus justifiable; while aquiring certain other kinds of debt – for instance, purchasing goods or services for individuals, which the individuals then consume in the normal course of their lives – leaves nothing for future generations aside from the accumulated debt, and thus is fundamentally unjustifiable.

Liz rightly points out that not all the debt we accumulate to pay for Americans’ healthcare is of the latter variety. It is certainly true, for instance, that going into federal debt to purchase a liver transplant for Steve Jobs would end up being a positive investment over time. There are certainly many people less notorious than Mr. Jobs – possibly millions – who might also fit into this “good investment” category.

So, Liz’ comment implies, it may be that increasing the federal debt to buy healthcare for Americans – at least some Americans if not all* – actually constitutes a good investment, and therefore good debt.

____
* Progressives, despite their protestations to the contrary, have actually given a lot of thought to which individuals should receive priority for healthcare services once they have the single-payer (centrally controlled) system they have long desired. They have occasionally, in unguarded moments, opined publicly on which sorts of Americans should receive expensive healthcare services and which should not. Their proposed rationing methodology indeed shunts healthcare services to those individuals who are judged to be “productive” by the Central Authority.  In their 100-year history Progressives have never been slow to pass harsh judgment on the worthiness of various groups or individuals, and there is no sign that they will behave any differently going forward. (DrRich, even if he were not an old fart, fears he would not wind up in the Central Authority’s “good” list.)
____

There are certainly examples of Americans happily agreeing to pay collectively for services consumed by individuals, because doing so is a good investment for the future. Chief among these is public education. Unarguably, an educated public is critical to continued economic growth and development, so (leaving aside for now the actual effectiveness of public education) paying collectively to educate all American children unquestionably benefits all current and future Americans.

Some would even argue – and DrRich would agree – that maintaining a certain level of health among the population is just as important to continued economic growth as is public education, and so paying collectively to achieve such a thing is equally a good investment. This is why DrRich fully supports many collective efforts to assure public health, such as assuring clean water, keeping air pollution to a minimum, and maintaining a healthy and safe food supply.

But DrRich’s thinking on the matter is even more radical than that. DrRich believes that it is indeed reasonable, and likely a good investment for the future, to use collective funds to pay for some of the healthcare consumed by individual Americans.  If Americans know that, no matter what their socioeconomic status, they are unlikely to become financially ruined because of some expensive medical catastrophe, they will be more willing to take the risks one traditionally takes (under a vibrant capitalist system) to grow one’s own wealth – and the overall economy.

So, to some extent, DrRich believes that collective spending on the healthcare of individual Americans can indeed be an investment for the future, just as President Obama says.

But the key phrase here is “to some extent.”  That is, we cannot furnish every bit of desirable healthcare for every individual, because that way lies ruin. We must set limits. DrRich has a simple rule for determining when our collective spending on healthcare is “too much.”  Our collective spending on healthcare is too much when the level of debt we’re accumulating to pay for healthcare is sufficient to threaten the economic destruction of our society. Triggering societal collapse, DrRich thinks, completely negates any “investment value” we might obtain by purchasing healthcare for individuals.

The healthcare system we have today, and the one we will have under Obamacare (at least, the kind of Obamacare that Progressives will admit to at this point), exceed even this very modest definition of “too much.”

DrRich has proposed a structure for an American healthcare system that would offer healthcare to each individual, without accumulating an unsustainable debt, and he has described it in detail in his book. Simply put, it is a 3-tiered system. In Tier 1, individuals would pay for (say) the first $3000 per year of their own healthcare expenses. Tier 1 spending would be funded from a tax-deductible, self-funded, self-owned Health Savings Account. Individuals below a certain income level would have their HSA funded by the government. Tier 2 would be a government-funded universal basic health plan, under which most additional healthcare expenses would be covered.  However, in the interest of keeping federal debt to a manageable level, Tier 2 would function under an open, completely transparent system of rationing. While most things would be paid for, some would not. The rationing system would allow the government to control how much it spends on healthcare each year, thus avoiding the crushing debt burden we are accumulating today. Tier 3 would be an optional, self-funded health insurance product that would cover extraordinary expenses that exceed the $3000 per-year individual limit, and are not covered under the Tier 2 rationing plan. Tier 3 would return the health insurance industry to the business of selling an actual insurance product (that is, a product that prevents individuals from financial ruin due to relatively unlikely future events), instead of whatever it is they’re selling today.*

____
* Thus, DrRich’s plan would give the insurance industry what it desperately needs – a new business model – without having to sell out to the Central Authority and survive under the diminished status of public utility.
____

Conservatives hate DrRich’s system because it includes a universal health plan. Progressives hate DrRich’s system because it does not offer enough centralized control, and indeed encourages (even demands) that individuals take chief responsibility for their own healthcare. So DrRich does not reiterate his plan for healthcare reform because he thinks it is even remotely possible that such a thing will ever be adopted, but simply to illustrate that it is indeed possible, with just a little effort, to imagine a healthcare system that actually meets the goals that Progressives and conservatives will admit to in public – and that honors the worthiness and the potential of each individual.

As difficult as it may be for most of his readers to believe, not everyone appreciates the erudite writings or well-reasoned analyses habitually offered up herein by DrRich. And despite the fact that DrRich takes great pains to express himself cordially even when addressing particularly contentious issues, and that he assiduously avoids personal attacks on his opponents, and indeed usually attributes lofty motives to them (focusing instead on their counterproductive methods or naive premises), it is not at all rare for DrRich to be the recipient of some rather negative, even personally hostile, communications.

And of all the topics likely to engender such negative feedback, none gets a more vociferous response than this: DrRich’s contention that among the many mandatory features that will necessarily comprise any Progressive healthcare system, the most obligatory, compulsory, requisite and non-negotiable of all will be the imperative to forbid individuals from having any meaningful control over their own healthcare destiny.

There are two basic reasons individual autonomy in healthcare must be stifled.

First, in order to achieve the most efficient and most effective outcomes within a Progressive healthcare system, all healthcare decisions will have to be made by a Central Authority, wielding its concentrated organizational and scientific expertise to maximize the public good.  Allowing these carefully calibrated decisions to be modulated by imperfect individuals (i.e., by non-experts) will fatally undermine the entire effort.

Second, and far more importantly, when one has at last devised a centrally-controlled, “universal” healthcare system (again, for the purpose of maximizing the public good), then allowing individuals to spend some of their own money on healthcare services that have not been officially sanctioned for them by the Central Authority will wreck the very legitimacy of that system. That is, to permit such individual prerogatives is tantamount to admitting that, perhaps, the Central Authority is actually NOT providing all useful healthcare services to all people (when, by definition, it is). Allowing individuals to purchase “extra” healthcare is a signal to the unwashed masses that there is “extra” healthcare to be had, and that the Central Authority may be holding out on them.

To say it another way, an essential feature of any Progressive healthcare system will be to carefully manage the expectations of the subject citizenry. To have certain subjects running around purchasing extra healthcare will fatally damage those managed expectations, and thus will fatally damage the Progressive healthcare system itself. Hence, it is imperative that individuals be constrained.

This fact has caused DrRich to say, many times, that the real battle over our new healthcare system will be the battle over whether Americans will be permitted to spend their own money on their own healthcare. Left-leaning readers take great umbrage at such a thought, since it is tantamount to accusing them of working toward a great tyranny. Most left-leaning Americans are still Americans, and therefore despise tyranny, and it is perfectly understandable that they would be angered at such an accusation. This is why, DrRich thinks, most left-leaning Americans will themselves be horrified when they at last glimpse where a Progressive healthcare system is inevitably taking us. Unfortunately, DrRich fears, such a realization on the part of well-meaning, left-leaning Americans will come too late to do us any good.

DrRich has attempted to document the efforts of Progressives to limit individual healthcare prerogatives, and while he himself finds the evidence compelling that they are deadly serious about doing so, he apparently has not made the case to the full satisfaction of many of his readers. So let him offer up the latest, particularly compelling, piece of evidence.

Last week, Washington DC District Judge Rosemary Collyer ruled that elderly Americans do not have the right to drop out of Medicare and purchase their own health insurance, unless they also forgo all Social Security payments, and repay the government any Social Security payments they have already received.

The notion that Americans MUST accept Medicare, of course, dates back to the Clinton administration, which in 1993 promulgated a rule in its Program Operations Manual System (POMS) to that effect. (DrRich has described how the Clinton healthcare reform plan intended to aggressively restrict individual prerogatives, and despite the failure of Hillarycare the Clinton administration still took several steps to do so.)  The lawsuit in question was filed by three elderly Americans (one of whom is Dick Armey), who wish to drop out of Medicare in favor of self-purchased health insurance, without having to sacrifice (and repay) their Social Security benefits.

Interestingly, Judge Collyer in 2009 denied a motion by the Obama administration to dismiss the suit, noting that “neither the statute nor the regulation specifies that Plaintiffs must withdraw from Social Security and repay retirement benefits in order to withdraw from Medicare.” Her preliminary ruling thereby confirmed the plaintiffs’ main contention.  So most observers assumed that the judge’s final ruling would also be in favor of the plaintiffs.

It was not. In her final ruling last week, Judge Collyer found a new interpretation of the Medicare statute itself that upholds the POMS rule. The Medicare statute, she now argues, specifies that people who are entitled to Social Security are automatically “entitled” to Medicare, and therefore if one elects to receive the Social Security payments one is owed, one must also accept Medicare. She flatly rejects the notion that when Congress says “entitled” it is implying anything optional, as in, “You can have it if you want it.” When you’re dealing with Medicare, she says, “‘entitled’ does not actually mean ‘capable of being rejected.’” When Congress says “entitled” Congress means you must have it – that it’s mandatory. Judge Collyer ends by sympathizing with the plaintiffs (or laughing at them – DrRich cannot tell for sure): “Plaintiffs are trapped in a government program intended for their benefit.”

The apparent change in Judge Collyer’s reading of the Medicare statute between 2009 and 2011 is disturbing. What made her originally read the plain language of the Medicare statute just like any literate American would, but then two years later read it as if she had to twist it into a presupposed “right” answer? We will never know, of course, but the turnabout seems troubling to DrRich.

It is instructive that the Obama administration would go to such lengths to prevent old farts from dropping out of Medicare. Medicare is not only in the red, but is a great fiscal threat to our national well-being. One would think they’d welcome the idea that some of our elderly might want to pay for their own health insurance, and save Medicare a lot of money. Instead, they fought it tooth and nail, even though the fight reduced them to absurdity. The Obama administration’s chief argument against the lawsuit was that the plaintiffs were lucky to receive such a boon as Medicare, and therefore suffered “no injury” by having to accept it, and so had no standing before the court. The judge herself ridicules the argument of the Obama administration: “The Secretary extolls the benefits of Medicare and suggests that Plaintiffs would agree they are not truly injured if they were to learn more about Medicare…The parties use a lot of ink disputing whether Plaintiffs’ desire to avoid Medicare is sensible.”

So as it now stands, seniors (unless they are rich enough to walk away from Social Security altogether) must accept Medicare. Admittedly, for most elderly Americans this is not a big deal – of course they’re going to accept Medicare. But, as DrRich has pointed out, current law already makes it nearly impossible for patients on Medicare to self-pay for denied medical services. Once you are on Medicare, you will get the medical services the Central Authority approves for you – and nothing more. In the not-too-distant future, this restriction is likely to become much more apparent to Medicare recipients. When and if the day comes when we would like to buy ourselves some medical care which the Central Authority would rather we did not have, we old farts will find that we are “entitled” neither to pay for our own healthcare, nor to drop out of the government program that so restricts us.

And at the risk of angering his readers yet again, DrRich asserts that we are one giant step closer to the day when it will become illegal for all Americans to spend their own money on their own healthcare.

In 2008, the Centers for Medicare and Medicaid Services (CMS) announced it would no longer pay for the treatment of “never events,” i.e., certain medical conditions in hospitalized patients which the Feds deem to be universally avoidable under all circumstances. These conditions included:

* Decubitus ulcers
* Two kinds of catheter-associated infections
* Air embolism
* Mediastinitis after coronary bypass surgery
* Transfusing patients with the wrong blood type
* Leaving objects inside surgery patients
* In-hospital falls

Then, having been delighted with the results of its original list (or dismayed that healthcare costs continued to skyrocket despite its original list) CMS subsequently proposed declaring several new conditions as “never events,” including:

* Surgical site infections following certain elective procedures
* Legionnaires’ disease
* Extreme blood sugar derangement
* A collapse of the lung resulting from medical treatment
* Delirium
* Ventilator-associated pneumonia
* Deep vein thrombosis or pulmonary embolism
* Staph infection in the bloodstream
* Disease associated with Clostridium difficile infection

Numerous commentators have expounded on the advisability of declaring these particular conditions to be “never events.” All agree that while certain of them clearly should never be permitted to happen (e.g., leaving sundry tools inside a patient’s abdomen, or transfusing the wrong blood), certain other ones are going to continue happening to some patients no matter how high the quality of the institution and the medical professionals.

Because this topic has been so well-covered in the medical blogosphere, DrRich does not need to comment any further on the unfairness of insisting that doctors prevent every single instance of conditions that are often not particularly preventable; or on the fact that insurance companies quickly followed Medicare’s lead and now also refuse to pay for these “never events;” or that hungry attorneys have voraciously begun suing doctors and hospitals for unavoidable complications because those complications have been federally designated as avoidable; or even the fact that, having so deftly expanded the horizons of what can be considered a “never event,” the feds have cleared the path for defining virtually any medical condition they choose as a “never event.”

(As a case in point, DrRich notes that the feds’ own guidelines on preventing delirium, referred to in their own “fact sheet” that purports to justify the expanded list of “never events” admits that there are no effective means of reliably preventing delirium.)

There’s also no point in physicians complaining publicly about this expanded list of “never events,” since the public is foursquare behind the notion that no medical complications should ever occur, and if they do occur it is somebody’s fault, and equally behind the notion that the Feds can squeeze quality into the system simply by demanding it to be so. Therefore, any doctors who openly objects to these new, tough quality measures will reveal themselves to be both anti-quality and low-quality doctors.

Rather, DrRich will refer back to the true mission of this blog, and simply explain to his readers how this new “never event” strategy furthers the true mission of Medicare and the insurers, which is to say, the covert rationing of healthcare.

For covert rationing is the chief operating principle of both the Feds and the private insurers. Indeed, their behavior resembles nothing more than the behavior of the closet, white-collar narcotic addict: while smiling their pasty smiles and desperately pretending to us that all of their new initiatives are only concerned with quality and nothing else, in reality, with every ounce of their being, their devious minds are constantly inventing new schemes to manipulate, deceive and twist each and every opportunity into some means of scoring their next covert-rationing “hit.”

Consequently, we cannot go wrong if we ask, every time we see some new healthcare program ostensibly aimed at quality improvement: Where’s the rationing?

One might think the rationing in this case is easy to spot. After all, if the feds stop paying for “never events” that actually cannot be avoided, they will save dollars right up front simply by refusing to pay for services rendered. But Medicare itself has estimated that its up-front annual savings from its original list of “never events” will be only about $20 million. And that seems hardly worth the effort.

The real savings will come from a place far more sinister than that.

The “never events” initiative – just as the Feds insist to us – is aimed at changing physicians’ behavior. But quite predictably, that behavioral change will not be in the arena of quality improvement (since no amount of quality improvement can stop “never events” that are inevitable). Rather, the behavioral change will be in the arena of risk avoidance.

While it is unlikely that doctors will ever refuse to care for high-risk patients who are experiencing genuine medical emergencies, it is quite likely they will stop recommending elective medical therapy for high-risk patients. Patients who seem particularly prone to infection, bed sores, falls, blood sugar abnormalities, blood clots, delirium, or who seem likely to need intravenous antibiotics (which predispose to C. difficile) will be particularly targeted. Roughly speaking, these patients will include diabetics, the elderly, anyone with a clotting abnormality or a history of blood clots, the obese, people with immune disorders, and the chronically ill. Physicians know by experience and instinct the sorts of patients to whom they ought to avoid offering elective medical services.

But in an era of evidence-based medicine, it is inevitable that savvy doctors will not want to rely on instinct and experience in this important matter. In order to conduct their risk avoidance in the most cost-effective way, they will want to base it on firm statistical evidence.

Accordingly, it is notable that investigators reporting in the Archives of Surgery last year began the important work of providing the kind of evidence-based risk avoidance which today’s physician actually needs. They published a large study designed to show which sorts of patients are most likely to experience post-operative “never events.” To the authors’ credit, their article was not written with the overt goal of providing a roadmap for risk avoidance. Instead it was written to show that “never events” are not really “never events” at all, but rather, are sometimes unavoidable complications; and that in certain readily-identifiable and (and obvious) subpopulations of patients, the incidence of “never events” is particularly high. That is, the authors were trying to convince the Central Authority that its policy on “never events” is far too Draconian, and that some leeway ought to be made for doctors who care for these higher-risk patients.

But of course the Central Authority already knows this, and also knows that the public fully supports its “never events” policy just as it is. The Central Authority, DrRich suspects, will see the Archives article for what it will end up becoming – a roadmap for surgeons who want to avoid the risk of encountering career-threatening “never events.” DrRich thinks Central Authority is quite satisfied with this study, and hopes to see more like it.

Conducting a risk/benefit analysis is nothing new to doctors. Doctors have always computed a risk/benefit analysis before recommending elective services to their patients (such as hip replacement, coronary artery bypass grafting, back surgery, gall bladder surgery, anti-obesity surgery, &c.) And in making those risk/benefit estimates, they have always taken into account the increased risk of complications faced by the elderly, the sick, the fat, and the malnourished.

But now, the “risk” part of the risk/benefit analysis suddenly must include three important new risks, and this time they are risks to the doctor him/herself, and not to the patients: 1) If any of these complications occur, no payment will be made for the (often very expensive) treatment the complication will require; 2) If a complication occurs, another “never event” will be tabulated in the federal database next to the doctor’s (and the hospital’s) name, which will inevitably show up in a public report card; and 3) Such a complication, previously considered a predictable risk, will now engender malpractice suits, based on the declaration by the Feds that these “never events” always constitute, by definition, grievous examples of poor-quality medicine.  The Archives article serves to place this new variety of risk analysis on firmer ground, and as such is an important new addition to the medical literature.

Lest anyone think that doctors would not really stop recommending clinically indicated care to patients just because of the personal risk it would entail, remember that it’s already happened, and is well documented. The government and the insurance companies have already conducted that experiment; it’s been completed, the results have been tabulated, reported, and duly noted. It turns out that doctors, like most other people, respond quite logically to negative incentives.

CMS knows exactly what it’s doing here.

Evidence is building that our pharmaceutical industry is becoming diminished.

Recently, for instance. Pfizer announced a $2 billion cutback in R&D funding. One does not so massively trim R&D because of mere cyclical economic conditions; one only does this as part of a fundamental restructuring in business strategy.

Furthermore, the Wall Street Journal has noted that the big drug companies have entered a period of rapid acceleration in company mergers – but decidedly not in the manner of “creative destruction” that usually typifies such deals. Rather, it is being done in the manner of constructing a hardened shelter from which to hunker down for the coming nuclear winter, which they believe will be brought on by government-induced disincentives for innovation and growth.

Now, nobody needs to remind DrRich that drug companies are evil. DrRich has watched along with all of you as the pharmaceutical industry has fired off a never-ending parade of wasteful “me too” drugs, mainly aimed at keeping the joints, bowels, bladders and genitalia of aging baby boomers nicely lubed up, then running a steady stream (so to speak) of television commercials regarding same, which renders prime time TV far too embarrassing to watch with adolescents (especially if one is of a certain age).

Other evil behaviors abound. We can all see the drug companies systematically fail to publish research that makes their products look less than spectacular; routinely over-hype research that suggests a modicum of effectiveness; callously corrupt doctors with plastic, logo’d ink pens, and likewise corrupt legislators with huge campaign contributions and rides on private jets equipped with plenty of booze and bimbos (causing the indignant legislators to propose laws against logo’d ink pens); and most annoying of all, gouge American citizens with astronomical prices for their new drugs, while selling those same drugs to Canadians and other undeserving foreigners at greatly discounted prices.

But still, most objective observers must reluctantly admit that, every now and then, and most likely by mistake, a drug company will do something worthwhile. Here and there they manage to come up with a real breakthrough product that cures a disease, prolongs survival, restores functionality, or relieves suffering. That is, the pharmaceutical industry (in spite of all its evil behavior, which DrRich hastens to remind his readers he has formally acknowledged, as recently as in the prior paragraph), has done a lot of good over the years. Ask a parent whose child has survived acute leukemia, or the person who has survived a life-threatening infection, or the woman whose heart attack or stroke was aborted with clot-busting drugs, or – yes, this too -  the aging Lothario who once again can enjoy fine and durable erections upon demand. Such individuals, even if today they would join us in cheering on the demise of the pharmaceutical industry, have undeniably had their lives improved by drug companies.

So the question we must address before allowing the pharmaceutical industry to roll itself into a ball and hide in the shadows for the duration, is not, “What have you done for me lately?” (since their inventions will live on even if they do not), but rather, “What can you do for me tomorrow?”  Some of us in the boomer class, for instance, would like to think that current research in the areas of Alzheimer’s, Parkinson disease, kidney disease, heart attack, stroke, arthritis, osteoporosis and cancer will allow us to remain healthy and functional for a few extra years. And judging from the massive amounts of money American citizens of all ages donate to medical research of all types, it is apparently not held among the whole of the populace that medical progress has already gone far enough. Many of us would not be entirely pleased to stand pat right here. Many of us would like to see more improvements.

And here is where we run into a dilemma.

Everyone agrees that the cost of new prescription drugs has been kept obscenely high in the name of maximizing profits, and that the rising cost of drugs has been one of the prime drivers of healthcare inflation. Accordingly, we hear much talk of federal price controls, drug re-importation, more restrictive FDA policies, and other tools the Central Authority can employ to greatly restrict if not eliminate the huge profits made by the evil men (and, one must say it, women) who run these drug companies.

The problem, of course, is that if the potential for reaping large (obscene, if you insist) profits from new drugs is significantly curtailed, the hugely expensive process necessary for drug companies to bring new drugs to market will be proportionally curtailed. So if we place price controls on drugs, then we’d better be happy with the drugs we have today, because those are likely the only drugs we’ll have tomorrow.

There are some who would be quite satisfied with this outcome, and who would readily sacrifice pharmaceutical progress to keep costs down. Still, others of us appreciate the fact that every few years some truly earth-shattering drug will hit the market, and would think it a shame if progress on such drugs – even if they are but a few scattered islands in a sea of boutique pharmaceuticals – were to come to a halt, and even if for a good reason.

So here’s the question: Can we have our cake and eat it too? Can we bring down the price of the drugs we buy, while at the same time allowing at least some pharmaceutical advances to continue?

DrRich is delighted to reply, “Yes, we can!”

And he hereby humbly offers a plan to achieve this very end. It is a system of voluntary price controls. Of course, DrRich is talking here about us doing the volunteering – we the consumers – and not the drug companies.

DrRich’s Voluntary Price Control System works like this:

1) Each American will make a formal declaration of whether or not he/she wants to participate in a system of voluntary price controls on drugs.

2) Those who opt to participate will receive immediate, substantial discount pricing on all available prescription drugs, such pricing to be fixed by a sympathetic government agency whose makeup will include a wide diversity of representation, except, of course, that drug company representatives and their physician shills will be specifically banned.

3) “Available prescription drugs” under this price control system will be any drug whatsoever appearing in the U. S. Pharmacopoeia – that is, any legal prescription drug – as long as that drug has been on the market for at least five years.

4) Individuals who choose not to participate in the price control system will pay whatever price the drug companies feel like charging them for all their prescription drugs, but they will be allowed to receive any drug, as soon as it is approved for marketing, with no five-year waiting period for new drugs.

5) Individuals may switch their status (between participant and non-participant) only during one 30-day window every 2 years, determined by their month of birth.

Why DrRich’s Voluntary Price Control System is brilliant:

For drug companies it is the prospect of making large profits from new drugs, and only that prospect, that drives drug development. So as long as we want new drugs to be invented we’ve got to allow for the profit incentive to continue, as odious as we may believe that to be. The chief advantage of DrRich’s system is that it maintains at least some of the profit motive – to whatever extent citizens opt to be non-participants in the Voluntary Price Control System.

Given the growing hue and cry for price controls on drugs, one can confidently predict that only rich people will opt for this non-participant status. Therefore, a side benefit of this plan is that the rich – those who, after all, can afford it, and who, by virtue of the very fact that they are rich, owe much to the rest of us – will fund virtually all progress in drug therapy. Again, this is a burden they ought to feel obligated to bear, being rich and therefore obligated.

In contrast, under the universal, mandatory price control system of the kind that many Progressives seem to favor, the drugs available to our citizens would be essentially “frozen in time,” and henceforth there would be little or nothing new under the sun.

Of course, under DrRich’s Voluntary Price Control System, access to new drugs would be similarly restricted for participants. Yet this voluntary system would be far better for even those who choose to participate than would be a universal price control system – because under DrRich’s plan at least some drug progress would continue. And as new prescription drugs matured in the marketplace, and once their hidden dangers and side effects – during the 5-year “shakedown period” -  manifested themselves on the physiology of the wealthy (another great benefit of DrRich’s plan), these drugs would, eventually become available even to plan participants, and at a substantial discount to boot. And because only the rich will be harmed for the first few years, perhaps the FDA can relax its safety standards a bit, and pass a higher percentage of the effective drugs that are submitted for approval.

The bottom line: a five-year lag in gaining access to new drugs is vastly better than never having any new drugs at all, especially when the burden of paying for all that drug development, and the risk of becoming early adopters of new, relatively unproven, relatively risky pharmaceuticals, falls entirely on the undeserving rich.

So, while at first blush you may not like DrRich’s system – it being two-tiered and all – on further objective and logical reflection DrRich is confident you will see that it is far better for everyone than the universal system of price controls which many now want.

DrRich suggests you contact your legislators immediately to recommend to them this brilliant new plan, before it is too late. In making your case, you might remind your dedicated congresspersons that a robust pharmaceutical industry is inherently good for America, what with all the campaign contributions, airplane rides, booze, bimbos, etc. it provides to grease the wheels of American democracy.

Two years ago, for instance, DrRich was “invited” to testify as a witness before a federal grand jury in a matter involving one of his consulting clients. While under oath, DrRich was caused to understand that the Feds (at least certain members of the DOJ) are well aware of this blog, and of the general tenor of its content. The impression left by this experience makes DrRich doubt whether many of his fans come from that particular precinct.

Further, the CRB has been the victim of two targeted denial-of-service attacks just in the last several months. Perhaps this is a common experience for healthcare bloggers, but then again, perhaps not. Finally, there’s the fact that last May (some readers may recall) a nasty hacking exploit completely trashed the CRB at the server level, resulting in the loss of the first three years of DrRich’s endeavors here (which, some have said, is the greatest tragedy to befall posterity since the burning of the Library at Alexandria).

And so, Dear Reader, while DrRich is certainly happy to be hosting Grand Rounds for the fourth time, and is particularly delighted with the quality of postings which he has the honor of featuring this week, it occurs to him that hosting an event with such high (and well-deserved) visibility might draw certain “extra attention” here.  So perhaps you had better read this quickly.

_____

We begin with HealthAGEnda, the John A. Hartford Foundation blog, which is posting a remarkable series of articles by Amy Berman, a senior program officer at that foundation, who has recently been diagnosed with an incurable form of breast cancer. Ms. Berman discusses very openly and frankly both the good and the bad aspects of the American healthcare system she is encountering  as she deals with this likely fatal illness. In this post, the second in a series, Ms. Berman talks about her ordeal in confirming what she already strongly suspected was a very bad diagnosis, and describes the comfort she experienced, while “meeting the enemy,” from compassionate but frank healthcare professionals. She had a much less favorable experience, which she describes in her first post, demonstrating just how devastating it can be for a patient to encounter a one-size-fits all physician. The impact such an encounter has on a patient who needs real medical help is especially relevant in an era in which doctors are being urged (coerced) into following just such an approach. Ms. Berman is an extremely brave and gracious woman, and the important insights she is providing in her efforts to chronicle her illness ought to be read by every health professional.

Henry Stern of Insureblog discusses the documented, systematic mistreatment of the elderly under the British National Health Service. Stern points out that while similar mistreatment of the elderly also happens in the American healthcare system, here it is sometimes not systematic, but rather is most often due to sloppiness or inadvertent error, and further, when it happens remedial actions (such as lawsuits) are often available. In contrast (evidence suggests), treating the elderly badly in the NHS seems to have become virtual policy. DrRich, of course, longtime president and sole member of Future Old Farts of America (FOFA), is confident that nothing of the sort will ever happen here in the U.S. where the government always has our best interests in mind, and he is sure that when government officials refer to the NHS as an ideal to which we should all aspire, they are probably not talking about this part of it.

Writing on a related topic, Julie Rosen of Bedside Manner tells about steps doctors and families can take to resolve disagreements on how aggressive one ought to be when deciding on the use of certain treatments for elderly and mentally incapacitated patients. DrRich finds Ms. Rosen’s recommendations appropriate, since all of them take place at the local level, with full participation of the patient’s loved ones, and do not (explicitly, at least) involve the heavy hand of any Central Authority.

And still speaking of the role of authority in deciding on aggressive treatments, The ACP Internist posts a news report about a court-ordered spinal operation on a 16-year old who was injured during a wrestling competition. Neither the young man nor his parents wanted the operation, which they feared might cause paralysis.  (Apparently, they were actually paying attention during the “informed consent” process.) Further, as the mother apparently demonstrated in a video shown on local TV, her son had a “full range of motion” prior to surgery. Nonetheless, the young man was removed to protective custody, and the court-ordered surgery was performed (apparently successfully, thank goodness, or else this might have turned into a controversial decision). One hopes the judge, in making his determination that the family was not acting reasonably, was not swayed by their expressed partiality to herbal medicine and homeopathy. Wacko as such practices may be, they do not appear particularly relevant in this case, given the family’s seemingly cogent argument that the risk/benefit calculation, as it had been presented to them by medical professionals, simply did not meet their threshold for such aggressive treatment. Apparently, it met the state’s.

The ACP Hospitalist offers a post from a doctor at Grady Hospital entitled: “10 ways to know that the nurses hate you.” These 10 clues as to nurses’ disapprobation are both amusing and true. However, after observing for over 30 years the kinds of behaviors to which nurses are forced to resort when they see that things are greatly amiss, but at the same time they are powerless to directly intervene, DrRich thinks this post more accurately ought to be entitled, “10 ways to know that the nurses think you are killing your patients.” The nurses may or may not actually hate the doctor for it, but they wish he/she would stop – and here are 10 ways in which they may often express that wish.

While some states are big troublemakers (and you know who you are), others are moving to implement provisions of Obamacare just as the Central Authority has decreed. Louise from Colorado Health Insurance Insider tells us that Colorado Senate Bill 168 was introduced last week to create the nonprofit healthcare cooperative which is required by all states under Obamacare. (Shouldn’t somebody tell the Colorado state senators that writing long tracts like this in ALL CAPS is considered impolite, as it is the documentary equivalent of shouting?) Louise notes that the healthcare cooperatives mandated by Obamacare may help to reduce the number of uninsured, but adds that Obamacare “will do little to address a range of other problems, including rising healthcare costs, the unaffordability of healthcare even for people who have health insurance, over-utilization of care, and the problems created when we link health insurance to employment.” While these are all legitimate points, regular readers will know how little DrRich himself goes in for such grousing.

Obamacare, after all, does so much! As a case in point, David Harlow at HealthBlawg writes about Accountable Care Organizations, a new entity which figures prominently under Obamacare, and which will be a chief vehicle for controlling the cost and quality of healthcare (i.e., for controlling physicians’ behavior). A lot of scary things have been written about ACOs (including, truth to tell, things written here at the CRB), but Harlow points out that ACOs might not turn out to be such a bad idea after all. For evidence, he points to some of the successes realized by AQCs (Alternative Quality Contracts) in Massachusetts, under admittedly favorable practice environments, and notes that some of these successes might be translated directly to ACOs. DrRich hopes he is right. But it is a little worrisome that nobody, including Harlow (as he himself allows), really knows what ACOs will end up looking like. Their structure is, as we speak, being fought over by numerous federal agencies (like a carcass being fought over by a pack of dogs), and among these agencies (DrRich shudders to contemplate) is the Department of Justice. But Mr. Harlow knows far more about this stuff than DrRich, so let’s all hope for the best. Short of defanging Obamacare, that’s about all one can do.

Amy Tenderich of Diabetes Mine submits a guest post from Valentine’s Day, written by Wendy Strgar, entitled “Healthy Sex, Healthy Love.” Ms. Strgar, who is known in some circles (circles of which DrRich himself is innocent) as a “loveologist,” and who markets the sexual-aid products to prove it, actually makes a pretty convincing argument that sexual activity can be an important part of reducing one’s risk for all sorts of medical problems. So: Are you one of those folks who has thought about having more sex, but you’re just not sure the pay-off is worth all the trouble? Read this post.

Dr. Pullen at DrPullen.com posts about the problem of anti-personnel mines, which continue killing and maiming innocent people all over the world, and for decades after hostilities cease. He rightly thinks the US ought to do more to resolve this problem, and in particular, he decries apparently serious suggestions some have made that we ought to deploy mines on our southern border to prevent illegal crossings. DrRich agrees with Dr. Pullen, but does not believe that mining the U.S. border will ever become a serious consideration (unless it is to prevent American citizens from sneaking southward to receive black market healthcare).

Doug Perednia at The Road to Hellth is writing a fascinating series on the wonders of Pay for Performance. In this, his second offering, Perednia provides some pretty overwhelming evidence, including evidence from studies which proponents use to justify P4P, that P4P demonstrably does nothing useful. Actually, DrRich should qualify that statement: It does nothing useful in terms of improving clinical outcomes. What it does do (as Perednia demonstrates) is to forcibly distract physicians from listening to their patients, to fully consume all the time allotted for a patient visit, and to actively discourage other forms of doctor-patient interactions which might lead to additional healthcare expenditures. So despite a now-well-documented lack of any improvement in patient outcomes, P4P is in fact achieving its actual designed ends, and thus must be counted a great success.

Dr. Joe Smith, who writes the Dr. Unplugged blog (a Medscape blog which requires free registration), travels the globe seeking out emerging technologies related to wireless healthcare. In his latest article Smith laments the fact that, so far, the healthcare consumer has completely missed out on the ongoing wireless revolution, a revolution that has greatly empowered consumers in virtually every other economic sphere. He concludes that despite this slow penetration, wireless technology inevitably will also transform the lives of healthcare consumers. DrRich agrees that this outcome is indeed inevitable, but thinks it may take a while. Resistance to the empowerment of individual healthcare consumers is deeply entrenched, massively well-funded, extraordinarily powerful, amazingly ruthless, and very widely distributed (from the beltway to the bedside). Such resistance is akin to the all-pervasive power of the Church 500 years ago, a power that was eventually broken, but that required the technology (printing press), the killer app (Bibles printed in the vernacular), the catalyst (Martin Luther’s 95 theses), the poorly-expressed but ultimately deep-seated desire of the populace for the knowledge being offered, and the fortitude to persevere through 300 years of reformational bloodshed. So, yes, history ultimately will win out with regard to wireless healthcare, but one fears it may take more than just the healthcare equivalent of the iPod or Facebook to see it happen.

The anonymous author of The Notwithstanding Blog is a Canadian medical student with a background in economics. In the short time this blog has been around, he (or she) has done some very cogent writing applying economic insights to medicine. The featured post describes why medical ethicists (despite their constant yammering about honoring the autonomy of the individual) almost always decide specific ethical questions the other way, that is, against individual autonomy. DrRich, in his ham-fisted style of analysis, always tends to blame this phenomenon on the fact that Progressives in recent decades have largely taken over the Ethicists’ house, just as they have taken over in most academic fields, and that Progressives as part of their DNA must always come down on the side of the collective. But Dr. Notwithstanding offers what is likely a better explanation, based on economics (the science of human behavior) instead of on political ideology. As you’ll see, in addition to being an original thinker Dr. N is an engaging writer. You should give this blog a try.

In stark contrast to Notwithstanding’s anonymous blog is Carolyn Roy-Bornstein‘s eponymous one. Here she describes one of the absurdities doctors see every day with the modern-day electronic medical records which are being adopted all over the place, with great fanfare (and with public subsidies), to streamline healthcare, reduce redundancy, eliminate waste, and assure quality care. Namely, while these new electronic records may greatly simplify the lives of the federal regulators and the forensic accountants who keep track of which doctors are being naughty and which are being nice, they often gum up the works for the people on the ground who are actually trying to take care of sick people. EMRs can do this in many ways, and Dr. R-B nicely describes one of them: She laments the reams of redundant, boilerplate, tree-killing verbiage these records spit out, each and every day, for each and every patient, a characteristic which makes the formerly simple task of figuring out how the patient’s doing today a constant challenge, a perpetual exercise in patience and persistence. and a powerful attractor for medical errors. She ends by speculating whether it might make things easier to have somebody sing these records to her. A nice thought, but DrRich thinks it would not help. What you’d get is an early Phillip Glass composition, in which the same nonsense phrases are repeated over, and over, and over, and over. . .

The Happy Hospitalist discovers that latex examination gloves (powdered, one-size-fits-all, Spic and Span brand), are available at 10 for one dollar at the local dollar store. His discovery suggests a couple of things. As Happy points out, hospitals which are expected to survive on Medicaid payments now have someplace to shop. And, if you want to bring down the cost of healthcare products and services, simply make them available for direct purchase by consumers.

Carolyn Thomas of Heart Sisters writes of journalist Melissa Mia Hall who died in her Texas home in January after avoiding medical help for her severe and persistent chest pain (regarding which she wrote a running commentary to friends – and ultimately to posterity – via e-mail). Ms. Thomas concludes that had Ms. Hall had health insurance (which she did not), she likely would have done more than just document the progression of her fatal heart attack. DrRich has no personal knowledge of Ms. Hall, and so cannot contradict this conclusion, nor does he wish to. However, a recent survey by the American Heart Association showed that in 2009, only 50% of women (regardless of insurance status) said they would call 911 if they thought they might be having a heart attack. DrRich, who has long lamented the feminization of men in our society, now utters his dismay at the converse – the masculinization of women. Ladies, if you have symptoms suggestive of a heart attack, don’t try to tough it out. Call 911.

Steven Wilkins of The Mind Gap tells how sessions of culturally-sensitive “storytelling” can break down certain cognitive barriers for some patients, and more fully engage them in their medical treatment. Wisely, Wilkins is not suggesting that beleaguered PCPs develop a stable of appropriate yarns they can spin for their recalcitrant patients during the 7.5 minutes the Central Authority has allotted for each “patient encounter.” Rather, he has several helpful suggestions for incorporating such storytelling into existing systems, which would leave the doctors alone to do what they’re paid for – making little electronic chits on Pay for Performance checklists.

Vineet Arora at FutureDocs talks about the universally-recognized phenomenon of the over-ordering of radiological diagnostic tests, which is detrimental both to patients’ health and to the healthcare budget. She discusses the many reasons too many of these tests are ordered. It boils down to the fact that the healthcare system provides physicians with extraordinarily strong incentives, at many levels, NOT to rely on their clinical judgment, but instead, in order to optimize their odds of professional survival, to just go ahead and get the test. Unfortunately the solutions Dr. Arora suggests to this difficult problem do not hinge on restoring the doctor’s clinical judgment as a legitimate decision-making tool. (This is no fault of hers; to restore respect for the doctor’s clinical judgment would require a wholesale change in how the healthcare system now operates.)  Instead, she suggests counterbalancing the strong coercions doctors feel to order too many of these tests, with new, and equally strong, coercions not to. Laboratory rats faced with similar, unresolvable imperatives to respond to two opposite stimuli, of course, quickly die of the stress.

Dinah from Shrink Rap notes that the FDA is about to take an action that may effectively render electroconvulsive therapy (ECT) a thing of the past. Specifically, the FDA is likely to reclassify ECT machines (which have been in clinical use since long before the FDA controlled such things) as Class II medical devices. If so, then for these devices to remain on the market, the two companies that manufacture them would have to conduct expensive new clinical trials to document safety and efficacy within 30 months. Observers judge that these companies would not have the resources to do so. ECT is a highly controversial procedure, and there are vocal groups which are trying to ban it – but for some patients with severe depression, Dinah points out, ECT has been a very effective and potentially life-saving last resort therapy. These unfortunate patients, apparently, can now join all the others whose response to various treatments resides in the tail of the standard distribution curve, and for whom the tailored, individualized therapy they require will no longer be an option.  So they will just have to make do with the guideline-driven treatments that suit the average patient just fine. Nonetheless DrRich predicts this change can be implemented with minimal outcry, since severe depressives, being often imbued with great inanition, likely won’t complain very vociferously about it.

Speaking of shrinks, Philip Hickey of the Behaviorism and Mental Health Blog writes about his observations regarding how and why “mental illness” has become such a growth industry. He says, “’Mental illness’ is a spurious explanatory concept whose purpose is to medicalize for profit the ordinary problems of human existence which our ancestors tackled and resolved without drugs for thousands of years.” While DrRich might not buy his entire thesis, there is much more truth in what Hickey says than one would like to think.  Among other things, when healthcare becomes a right, then the more struggles of the normal human experience we decide to turn into a medical diagnosis, the more it becomes society’s obligation to alleviate those normal struggles. There is a natural endpoint to this process of over-medicalization, of course, but it is not pleasant to contemplate.

Dr. Wes speculates on what is really different about the new pacemaker leads which recently have been declared officially MRI-safe by the FDA. Wes suggests that much of the extraordinarily expensive and time-consuming effort that was made in obtaining the “MRI-safe” label had more to do with the incredible regulatory maze that had to be navigated, than with any actual engineering changes. DrRich, who a few years ago was peripherally involved as a consultant in a similar effort (with a different company), declares Dr.Wes’ speculation to be likely pretty accurate. But fear not, for Medicare will be reimbursing the manufacturer for its regulatory ordeal for many years to come.

The venerable DB of DB’s Medical Rants offers a timely rant about how those who create the clinical guidelines which dictate the practice of modern medicine often do so inadvisedly, and sometimes with their own (possibly cryptic) agenda in mind, and as a result of such guidelines, patients may die. DrRich himself has covered this same topic lately. DB’s commentary hits the mark.

Paul S. Auerbach of the Medicine for the Outdoors Blog provides this post on cholera vaccines. It turns out that cholera vaccination is a little less than straightforward, and given the relatively small amount of vaccine available worldwide, would not be suitable for wide-scale use. So as far as cholera prevention goes, pray for sanitation.

Rich Elmore and Paul Tuten at HealthcareTechnologyNews write the wonderful news that the Direct Project has launched. The Direct Project, they tell us, is an implementation of a secure, health-related e-mail standard designed to “allow health practitioners to securely exchange health data, medical records digitized to be easily shared between doctor’s offices, hospitals, benefit providers, government agencies and other health organizations, all across America.” This sounds like a pretty good idea, except perhaps for the “government agencies” part, since, for many of us, these are the very folks we’d least want looking at our most private personal information. As for the patients themselves, it is not clear whether they also will have ready access to all this extremely secure information about their own health, or whether instead they will have to wait until the information finally shows up on Wikileaks.

February 24 – DrRich has been petitioned by the authors to issue a correction for this last item. In order to do complete justice to them, DrRich reproduces their suggested correction in its entirety:

“The Direct Project encrypts the information being transmitted.  No one other than the intended received can get the information.  There is nothing stored using the Direct Project technologies – it serves only as a transport mechanism to enable, for example, a provider to securely send information to a consulting physician.  The goal is to replace the pervasive fax machine with something more secure, more modern and able to be used by healthcare stakeholders with the most basic technology (internet access and a PC) up to the most sophisticated user of an electronic health record.”

DrRich thanks the authors for correcting any misapprehensions he may have inadvertently introduced.  To be clear, when the Feds get your personal health information, and when you have difficulty obtaining it yourself, that will not be the fault of Direct Project, whose purpose is merely to assure that the data gets sent only to the person/agency which is targeted to receive it, and no one else.  DrRich leaves it as an exercise for his readers to determine whether his original commentary may still offer any value.

____

Thanks for speed-reading Medical Grand Rounds this week.

Next week Grand Rounds will be hosted by The Examining Room of Dr. Charles.

____

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.

____

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

____

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.
____
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.

In his last post, DrRich suggested that the Guideline Wars (i.e. the bloody battles over who gets to establish the patient-care guidelines that determine which patients will get which medical services, and which medical specialists will get to provide them) are about to enter the Obamacare phase, in which those who make the guidelines will no longer be medical professional organizations, but agents of the federal government. DrRich helpfully labeled the various guideline panels provided for by the Obamacare legislation as the “GOD panels” (for Government Operatives Deliberating), in order to avoid using the more inflammatory “death panels” terminology favored by certain less sophisticated commentators.

In addition, DrRich pointed out that his own tribe of medical specialists – the cardiologists – may perhaps be in a better position than most other physician tribes to manipulate the deliberations of these GOD panelists. The cardiologists would attempt such manipulations, DrRich suggested, by “pre-spinning” certain critical data from clinical trials, before that data is taken up by the government panels.

From their long experience in fighting the Guideline Wars, cardiologists understand that data from clinical science does not invariably lead to a fixed conclusion (as most proponents of evidence-based medicine seem to believe), but rather, can often be shaped into whatever sort of conclusion one might want to reach. Just as different primitive cultures discerned different constellations when they looked up into the same night sky, so will different groups of experts come to different conclusions when they look at the same clinical data.

Accordingly (DrRich submits), cardiologists have already embarked on the task of pre-spinning the data, such that when the GOD panelists look for the first time up into the vast and chaotic sky of clinical evidence, they will have in hand a map of the constellations as seen by the cardiologists.

To illustrate what he means, DrRich calls his readers’ attention to the SYNTAX trial, a clinical trial designed by cardiologists and their industry partners for the purpose of reaching a specific conclusion, but which (unfortunately for cardiologists) reached the opposite conclusion. If the data from the SYNTAX trial should ever fall into the hands of the GOD panelists (or any other guideline panels) in a pristine fashion, it could spell disaster. So the cardiologists have spent nearly two years attempting to make the data say what they want it to say, and today, after continuously massaging the data, issuing press release after press release, making presentation after presentation, and publishing academic paper after academic paper, it would be at least a little surprising if the God panelists, surveying this body of pre-spun data, would fail to produce clinical guidelines which provide the cardiologists at least some of what they’re after.

The SYNTAX trial randomized 1800 patients with complex coronary artery disease (i.e., CAD that produces either significant blockage in the left main coronary artery, or severe triple-vessel disease) to therapy with either bypass surgery or drug-eluting stents (DES), and assessed their long-term outcomes.

In general, patients with stable CAD (i.e., those who are not currently having a heart attack or unstable angina) do just as well with aggressive medical therapy as they do with invasive therapy. People like the ones enrolled in SYNTAX, however, are the exception to this rule. That is, patients with either of these two specific patterns of complex CAD have been shown to have improved survival if they receive bypass surgery. Indeed, these patients represent a virtual “last stand” for cardiac surgeons – they are nearly the only patients cardiologists (at least some cardiologists) still feel obligated to refer for bypass surgery. And, as one might expect, in their decades-long turf war with cardiac surgeons (a war from which they will not desist until they see the great majority of cardiac surgeons seeking jobs as beer vendors at sporting events), cardiologists have long chafed at this singular remaining obligation to refer.

Accordingly, SYNTAX, a study instigated by cardiologists and sponsored by Boston Scientific (a manufacturer of DES), was intended to show that with modern cardiac stents, stenting yields outcomes that are not significantly inferior to bypass surgery in these patients. Specifically, that is, SYNTAX was designed as a “non-inferiority trial.” This was certainly a modest goal – some might say too modest – but a positive result would enable cardiologists (the gatekeepers to all invasive CAD therapy) to simply keep these patients for themselves, just as they now do with all the other CAD patients. The SYNTAX trial asked the question, “Do I really have to refer these patients to the cardiac surgeon?” And the desired answer was, “No, it apparently is not statistically provable that you absolutely have to refer them, one supposes.” Judging from the study design, that answer would have been plenty rigorous enough for the study designers.

Alas, however, when the one-year follow-up data for the SYNTAX study was analyzed, the results turned out to be negative; stenting was significantly inferior to surgery. The endpoint of the study was a composite called MACCE (Major Adverse Cardiac and Cerebrovascular Events), and in this study included death, heart attack, stroke, and the need for more revascularization procedures. The bottom line is that in SYNTAX, the risk of MACCE was significantly higher for stenting than for bypass surgery. The study failed to meet even the modest non-inferiority goal the cardiologists had devised for it.

The one-year data for the SYNTAX trial was published in the spring of 2009 in the New England Journal of Medicine, just as the battle over healthcare reform was taking shape, and nearly six months after Sarah Palin had reported her mysterious vision of death panels. But whether one wanted to call them death panels, GOD panels, or panels of distinguished monkeys, it was clear by the time SYNTAX was published that the government, and no longer the physicians’ own specialist organizations, would be manufacturing all clinical guidelines in the near future. So disaster loomed.

But, the cardiology community quickly rallied, and launched into a concerted effort to spin the results of SYNTAX from a disaster into a victory, or at least, to something akin to victory. And the efforts of the cardiologists in this regard have been impressive over the last 18 months.

Within minutes of the publication of the original SYNTAX article, scores of press releases were launched, and scores of “experts” were dispatched to give interviews, implying that the SYNTAX study was a major, ground-breaking victory for stenting.

For instance, here’s the link to an article in the New York Times (subsequently reproduced in hundreds of newspapers around the country) entitled, “Heart Stents Found As Effective As Bypass For Many Patients.”

And here’s a triumphant press release from Boston Scientific, the study’s sponsor, in which the negative overall results of SYNTAX are buried deep within the 6th paragraph (following all kinds of positive-sounding fluff), and are difficult to locate even if you are specifically looking for them.

And here’s the more-than-triumphant press release from one of the leading clinical sites for the SYNTAX trial, which reads, in part:

“At NorthShore, we experienced stunning outcomes [emphasis DrRich's] in patients whose only option would have previously been bypass surgery,” said Ted Feldman, M.D, F.S.C.A.I., Director of Cardiac Catheterization Laboratory, NorthShore University HealthSystem, and a lead investigator of the trial. “The data in this study will provide cardiologists with additional information as they determine treatment therapy for patients with complex CAD.”

Most remarkable of all, we have the spectacle of the lead author of the SYNTAX paper, Dr Patrick W Serruys himself, telling Heartwire immediately after publication of the paper, that the paper’s concluding sentence (i.e., “CABG as compared with PCI is associated with a lower rate of MACCE at one year among patients with three-vessel or left main coronary artery disease (or both) and should therefore remain the standard of care for such patients.”), is just plain wrong. Serruys declared that this concluding sentence actually “is not the essence of the trial.” He only allowed that concluding sentence to appear in the paper, he said, “because the New England Journal of Medicine wanted something more conservative.” (Apparently, having the paper appear in a prestigious journal overrode the necessity of having the paper accurately reflect what the authors meant to say.)

In any case, Serruys insisted (despite the conclusion expressed in his ink-not-yet-dry paper) that many patients like the ones enrolled in the SYNTAX trial can safely be treated with stents, and indeed, he announced that he and his co-investigators were hard at work teasing apart the SYNTAX data in order to develop a so-called “SYNTAX score,” that would help cardiologists determine which patients they can treat themselves, without referring them for surgery. So indeed, despite the negative results, and despite the conclusion written in their own paper, the SYNTAX trial was immediately spun by key trial participants themselves into a win (while not a complete victory, still a win).

Before his readers come down too hard on the cardiologists for such behavior, DrRich feels obligated to point out a partially mitigating truth. Namely, cardiologists believe to the depths of their souls, notwithstanding the largely negative body of medical literature to the contrary, that stenting coronary artery blockages – in virtually any configuration and any clinical situation – saves lives. And if they haven’t been able to prove that yet, it’s just because of the vagaries of clinical research. One must not let spurious results from imperfect research block the Truth, lest one allow great harm to come to humanity.

The results of the SYNTAX trial must simply be wrong, cardiologists believe, and so they would be gravely harming patients if they did not take whatever steps were necessary to render the results of SYNTAX more favorable to stenting. To do otherwise would cause thousands of clinicians to make inappropriate decisions.

In this way, DrRich believes, cardiologists are no more guilty than are Progressives, another category of humans who believe with their hearts and souls in something that is simply not true (in the case of Progressives, that the great mass of humanity will willingly suppress their own individual interests in favor of the interests of the collective). Like the Progressives, cardiologists are often very nice, well-meaning, sensitive and compassionate individuals, and some of them would even be fun to go out with for a beer.

In other words, DrRich pleads, cardiologists are not being particularly evil in spinning the SYNTAX trial results; they are simply doing what comes naturally, and what they deeply believe to be the right thing.

This is why the SYNTAX investigators were convinced that, buried within the vast body of clinical data the SYNTAX trial has generated, there simply MUST be something useful to cardiologists. Accordingly, the SYNTAX investigators dived head-first into the proverbial room full of manure, enthusiastically digging for the pony which simply must be in there somewhere.

And indeed they quickly found their pony.

And here it is: While a straightforward analysis of the SYNTAX study shows that bypass surgery wins hands down over stenting, if one delves a bit deeper into the data, one finds that one of the components of the MACCE endpoint – the incidence of stroke – was statistically higher among the patients randomized to bypass surgery. One also finds that the incidence of needing revascularization during follow-up was higher in the stent patients. So, taking these two interesting observations together, the cardiologsts have concluded that patients receiving bypass surgery are trading a reduced need for subsequent revascularization for an increased risk of stroke – a bad trade indeed. Therefore, despite the overall results of the study, they have concluded that stents are better than bypass surgery for at least some patients. (And they promised to discover for us, during the data-mining exercise from which their “SYNTAX score” was subsequently invented, which patients those are.)

And this – the reduced incidence of stroke seen in the stent patients – is the basis for the celebratory statements which were issued by the SYNTAX investigators upon publication of their original paper.

DrRich agrees that, as a general proposition, he would probably rather have an extra invasive cardiac procedure than a stroke, and suspects that most people would say the same thing. But before we all buy what cardiologists are selling here, DrRich would like to make a few observations.

First, the results of the SYNTAX trial are the results. Stenting did not meet even its modest non-inferiority endpoint, and it failed to meet it by quite a lot. Once the pre-designated endpoint of a randomized clinical trial is determined, any remaining observations that can be gleaned from the large amounts of data invariably generated by such trials must be viewed as inconclusive, as merely hypothesis-generating. Such observations are not to be regarded as having sufficient statistical surety to vastly change medical practice, or to figure into evidence-based guidelines. So, another clinical study would need to be conducted to prove the hypothesis that strokes are less frequent with stenting than with bypass surgery in patients like these.

Similarly, the “SYNTAX score” – which indeed was generated and subsequently published as a “guide” for cardiologists treating patients with complex CAD, and which is therefore presumably being used today by cardiologists all over the world to select which of these complex patients they can just go ahead and stent rather than refer for bypass surgery – has no business being incorporated into clinical practice. An exercise like this – in which investigators comb retrospectively through the clinical data, selecting out patients who had good results with stenting, then devising a group of characteristics that appears to differentiate them from those who did not – cannot possibly yield a validated, widely-applicable clinical tool. If they want to claim that their SYNTAX score is clinically useful, they need to conduct another randomized clinical trial to test that hypothesis.

Next, and most remarkably, there’s the almost universally-ignored fact (reported by Dr Friedrich W Mohr, co-principle investigator of the trial), that among patients assigned to bypass surgery in the SYNTAX trial who experienced a stroke, nearly half of them had their strokes PRIOR TO SURGERY. What this means is that, in reality, the bypass surgery itself did not cause those strokes, a fact that ought to cause serious damage to the chief assertion of the stent-proponents. This fact alone turns their pony into a pig. The claim that stenting instead of surgery would have avoided these strokes is largely, if not entirely, spurious. Indeed, if anything, the fact that patients “randomized” to surgery apparently had a lot of strokes in the brief period of time between the act of randomization and the surgery itself ought to make one question whether the selection of therapy was really and truly random, or whether, somehow, patients who looked particularly sick got sent preferentially to the surgeons.

And finally, the clinical choice as it has been starkly painted by many proponents of stenting – that the real trade-off in choosing between stenting and bypass surgery in these patients is the choice between the higher risk of stroke with surgery versus the higher risk of revascularization with stenting – is incomplete and misleading. Presenting the choice in this way clearly favors stenting, and this presentation entirely explains the positive press releases and subsequent media coverage of the SYNTAX trial. But this is not a valid comparison of risks for several reasons:

1) As noted above, the actual risk of stroke posed by performing bypass surgery in the SYNTAX trial has been substantially overstated for public consumption (by implying that the surgery caused those strokes, when half occurred prior to surgery).

2) Surgeons in the SYNTAX trial most often did not employ newer techniques now in routine use, such as off-pump surgery and LIMA grafts, both of which can substantially reduce the risk of stroke and other embolic phenomena.

3) Re-occlusion of the involved arteries (which occurred about equally in both groups in this study, and which spokespersons for SYNTAX seem to brush off as not such a big deal), is an entirely different phenomenon in patients who have received DES than it is in patients who have had bypass surgery. After bypass surgery, re-occlusion tends to occur gradually, and the patient generally experiences recurrent symptoms of angina. But in DES, re-occlusion much more commonly occurs acutely, and catastrophically, leading rapidly to permanent cardiac damage and often, to sudden death.

4) Item # 3 might explain why the composite endpoint of “death, heart attack and stroke” was equal in both groups, even though stroke was significantly higher in the surgery group. That is, in order for the math to work out, the remaining dyad of “death and heart attack” necessarily must have been higher in the stent group. As far as DrRich can tell, this point has never been discussed in public.

5) In order to avoid the catastrophic re-occlusions seen with DES, cardiologists now insist that their DES patients take long-term, even life-long, Plavix, a powerful blood thinner. As the purveyor of a patient-oriented website on heart disease, DrRich cannot tell you how many distressed and stented-up patients have written to him with the following lament:

“My doctor put in one of those drug coated stents and has me on Plavix. He says if I stop the Plavix I could die, and won’t let me stop it for any reason. But I need my gallbladder out because I keep having gallbladder attacks, and the last one gave me blood poisoning. My surgeon says I need the surgery but he won’t do it unless I stop Plavix, and my cardiologist says no stopping the Plavix for any reason. What can I do? Can they just take these stents out so I can stop the Plavix?”

There is no easy answer to this question, at least not that DrRich can find. The DES patient commonly is left in the middle of a pissing match between surgeon and cardiologist. The fear of the cardiologist is that when one stops Plavix, there is a risk of sudden, catastrophic thrombosis of the coronary artery. But surgeons simply cannot operate safely on patients taking this drug. Few cardiologists seem to explain this to their patients before placing DES.

And more to the point at hand, none of the cardiologists spinning the SYNTAX trial are explaining to the public the implications of long-term Plavix. Even if their claims that stenting yields significantly fewer strokes turned out to be accurate, the choice here is clearly NOT a simple one between a higher risk of stroke on one hand, and a higher risk of needing “revascularization” (if they survive the re-occlusion, that is) on the other. There’s a lot more to think about than that, and cardiologists who imply otherwise are being either disingenuous, or delusional.

Just last week, SYNTAX investigators reported on the three-year outcomes in patients enrolled in the trial. The results, similar to the one-year outcomes, remain strongly in favor of bypass surgery at three years, and indeed, the incidence of stroke in stented patients has “caught up” with the incidence of stroke in the surgery patients.

This persistently bad news still does not really phase the cardiologists, who are now saying that the results of SYNTAX don’t really apply any more in any case, because drug-eluting stents have been improved since the trial was done.

It would appear that the cardiologists are going for some sort of official announcement to the effect that that the results of SYNTAX are, for practical purposes, indeterminate, and that what is needed is a new clinical trial, in which patients randomized to DES will receive the latest generation of stents. (Since there is a new generation of stents every year or so, this entire process can be repeated as needed until the cardiologists finally get the results they’re looking for, at which point they can declare final victory and stop.)

Summary:

All medical specialists should take a lesson from the cardiologists. In an era in which specialist organizations will no longer be writing the clinical guidelines for their own specialty, it is necessary to aggressively pre-spin any important clinical data upon which the GOD panels will be deliberating.

Considering the SYNTAX trial as a case study, one sees how it is possible to take the most straightforward results from a very straightforward clinical trial and, if not turn a negative outcome into a positive one, at least introduce enough complications, nuance, spin and uncertainty to cause any self-respecting GOD panelist to hesitate in making a definitive pronouncement on those results. Then, if you couple all the uncertainty you’ve created with a loud call for yet another clinical trial – one that will take into account new equipment, new techniques, new scoring systems &c., and that promises to clear up all the confusion you’ve dug up as a result of the last clinical trial – then you stand a decent chance of at least getting a postponement on any new guidelines harmful to your cause.

And this, you neurologists, gastroenterologists, pulmonologists and all you other, less savvy medical specialists, is how one can manage the GOD panels.