Some Implications Of the New PSA Recommendation

DrRich | October 24th, 2011 - 7:05 am

Podcast:

The United States Preventive Services Task Force created another hub-bub recently when they released their latest, updated recommendations on whether men should routinely have PSA testing for the early detection of prostate cancer. The USPSTF’s recommendation was simple and straightforward: No.

News reports on this new recommendation have fairly accurately portrayed the arguments on both sides. Proponents of PSA testing are in an uproar because prostate cancer kills many men, and its early detection makes it easier to treat. Without PSA testing, the early detection of prostate cancer is difficult and often impossible. But those siding with the USPSTF point to randomized clinical trials showing no significant reduction in mortality in populations of men who have had PSA screening, and further, that men who have PSA screening end up having a lot of very unpleasant and expensive medical procedures which can leave them with life-altering side effects.

DrRich is by no means an expert on prostate cancer or PSA testing, but as it happens he is an American male who is within the age group addressed by this new recommendation. So he indeed has a legitimate interest in whether the USPSTF has made a wise decision or not.

To help him decide whether this new recommendation is a reasonable one, DrRich has gone to the source: to the document published by the USPSTF itself in announcing its new recommendation. Helpfully, the USPSTF has laid out in detail the specific clinical studies it relied upon, and the rationale it used, to synthesize the results of those studies into a concrete recommendation.

The USPSTF document points out two major conclusions which can be gleaned from the medical literature on PSA screening. First, when PSA screening is applied to large populations of men, it is difficult to demonstrate a reduction in mortality. Of two large clinical trials comparing men randomized to PSA screening to those randomized to “standard care,” one found that PSA screening yields a relatively small but statistically significant reduction in cancer-related deaths, but the other showed no mortality benefit. So, given a large population of men eligible for screening, doing PSA testing appears to yield a benefit that is either small or non-existent. And as a result, from a public health standpoint a recommendation to do widespread PSA screening is simply not justifiable based on current evidence. And this finding accounts for the USPSTF’s new recommendation.

But the second major conclusion that is revealed by the medical literature is that, for men in whom screening has actually detected early prostate cancer, subsequent treatment significantly reduces mortality. This result addresses one of the big questions often raised about early detection of prostate cancer, namely, whether the cancers detected by PSA screening actually require treatment. Many of these early cancers apparently never cause death, so many have speculated that “watchful waiting” might be a reasonable course of action rather than aggressive prostate treatment. But the USPSTF’s review of the relevant studies shows that when early-stage prostate cancer is identified, the best clinical trials available show a significant reduction in cancer-related death and all-cause mortality with either surgical prostatectomy or radiation therapy.

As the backdrop for these two major conclusions, the USPSTF strongly emphasizes the drawbacks of PSA screening. This screening often leads men to experience some very bad outcomes from prostate biopsies, or from therapy for prostate cancer. The very nasty complications resulting from these procedures are all too frequent, and are very difficult to even think about let alone experience. Furthermore, pursuing all those  positive PSA tests is extraordinarily expensive for the healthcare system. The reasoning offered by the USPSTF in making their new recommendation relies heavily on the price which men must pay, in terms of complications, in pursuing the results of a positive screening test.

DrRich has long been disturbed by the state of the art of both prostate cancer screening and prostate cancer treatment, by the lack of obvious progress in improving these things, and by the seeming complaisance with which many urologists seem to accept the status quo. PSA screening appears far too sensitive (too many false positives, leading to too many biopsies). Prostate biopsies often yield both false positive results (detecting cancers that are probably clinically meaningless) and false negative results (missing cancers that are clinically important). And the numerous treatments available for treating prostate cancer (all of which are very unpleasant) have not been rigorously compared, leaving the various “camps” of urologists to argue that their pet treatment is the best one, and all those other urologists have their heads up their ass.

All this confusion and uncertainty places the patient faced with the prospect of whether to have a PSA test, or worse, with newly-diagnosed prostate cancer, in a complete quandary, and apparently with no objective means to resolve what he ought to do next. But despite all these shortcomings, the urology community has aggressively turned PSA screening and the cascade of uncertainties (and resultant procedures) that flow from it into a burgeoning industry, to the extent that one must wonder how badly these specialists want to clarify the current muddle. And for this reason, it is difficult to take the loud objections being made by the American Urological Association against the USPSTF’s new recommendations very seriously.

So from a public health standpoint, the USPSTF recommendations on PSA screening seem reasonable to DrRich.

However.

DrRich keeps coming back to the second major conclusion from the USPSTF’s analysis of the medical literature on prostate cancer screening: Even with all the drawbacks associated with PSA screening, and even with all the conjectures about whether these early prostate cancers really need to be treated after all, it turns out that if prostate cancer is detected by some screening technique, then treating that cancer saves lives. And DrRich notes that while the USPSTF dutifully describes this result in the body of their report, they do not mention it in the Abstract of their report, and they do not seem to have given it much weight, if any, in their final recommendations.

But it seems to DrRich that this is an important result, and ought to be taken into account. It should not be simply brushed off as irrelevant, or unworthy of notice. It begs to be explained.

How can it be that, on one hand, offering PSA screening to a large population of men does not seem to result in much overall mortality benefit, whereas on the other hand, if you do find prostate cancer when you screen for it, then treating that cancer significantly reduces mortality?

Most likely the explanation lies in the dilution effect. The moderate (but statistically significant) benefit of treating early prostate cancer is washed out when those patients are included in a much larger population of men who are eligible for screening, and who may or may not have prostate cancer, which may or may not be detected adequately by current screening techniques, and if it is detected may or may not be treated.

To see how such a dilution effect might operate, let’s consider seat belts. Everyone knows that seat belts save lives. So let’s do a study to prove it. One way to do this would be to compare the mortality rates of people who are in automobile accidents, according to whether they were or were not wearing seat belts. Odds are it would be fairly easy to show a mortality benefit with seat belts. But now let’s compare the mortality rate of all drivers over a 5 or 10 year period according to whether they were wearing seat belts, regardless of whether they were ever in an automobile accident. DrRich suspects you would not be able to demonstrate a mortality benefit with seat belts in this second study.

The PSA screening studies that the USPSTF relied on to make their PSA recommendations are analogous to this second seat belt study. The prostate cancer treatment studies that did show a mortality benefit are analogous to the first seat belt study.

Please note that DrRich is not comparing PSA screening to wearing seat belts. Wearing seat belts does not lead to a lot of unnecessary expense, nor does it create life-altering side effects. PSA screening, given the state of the art, is neither inexpensive nor benign.

But despite its major drawbacks, PSA screening does detect early prostate cancer. And if you measure outcomes from the point where the prostate cancer is actually diagnosed (instead of from the point where you decide to do PSA testing), survival is measurably increased by its early detection and treatment.

So the dichotomy is explained. From a public health standpoint, where you have to decide what the result will be on a large population of individuals if some screening test is implemented, it does not make sense to do PSA screening. But if you are an individual who might have prostate cancer, in whom the early detection of that cancer might save your life, then it might make sense to do the PSA screening. (Whether it does or not depends on how you, the individual, assign relative weights to the notion of dying from prostate cancer vs. the inconvenience, expense, pain, and possibly horrible side effects from PSA testing and what it might lead to.)

So while from a public health standpoint it would be a mistake to recommend widespread PSA screening, from an individual standpoint either decision – to have or forgo PSA screening, depending on how you yourself weigh the tradeoffs – would be entirely reasonable.

But individuals are not allowed to decide this for themselves. This is no longer the kind of decision which individual doctors and patients are supposed to be making any more. In fact, it is now illegal to do so.

And this, Dear Reader, describes the problem with the USPSTF decision on PSA screening. For, in fact, the USPSTF is no longer making mere “recommendations,” which doctors and patients might take into account if they wish as they decide whether some preventive healthcare measure is right for an individual patient. Rather, the USPSTF rulings now determine whether you and I, as individuals, will or will not receive that preventive measure.

Obamacare, which is now the law of the land, makes the USPSTF the final arbiter of which preventive services are to be covered by private insurers (Section 2713), by Medicare (Section 4105), and by Medicaid (Section 4106). Only those that have achieved a grade of A or B by the USPSTF will be covered. And if you believe you will be able to purchase for yourself PSA screening (or any other medical service which Obamacare has decided not to cover) you have not been paying attention. Perhaps you can do so today (if you’re not on Medicare or Medicaid), but probably not for long.

What all the news outlets have forgotten to mention, in their coverage of the PSA controversy, is that the USPSTF has been officially converted from a panel that simply makes recommendations which doctors and insurance companies can take or leave alone, into a panel that determines definitively what is covered and what is not – and indeed, into the chief tool by which our leaders will seek to withhold expensive preventive services.

And while in the particular case of PSA testing, he is not particularly sorry to see the new USPSTF recommendation, DrRich submits that, given the general nature of medical screening tests, it is child’s play to set up a clinical trial that would “prove” (given the expense of the test, the false positives, the false negatives, the side effects of the test itself, the side effects and expense of the follow-up tests needed to see whether a positive screening test is truly positive, the expense and side effects of the treatment that will be used if the diagnosis is actually confirmed, the relative efficacy and inefficacy of that treatment, not to mention the dilution effects of having to screen a large number of individuals to find the relatively few who actually have the condition of concern and will benefit from its treatment) that there is no preventive screening test you could name that produces an overall benefit to the population.

DrRich has long predicted that the brilliant people in our news media will be continually “surprised” each time some heretofore sacred medical screening test is declared by the all-powerful USPSTF to be, after all, useless.

This being the case, can we just stop pretending that Obamacare is all about prevention, disband the USPSTF altogether, stop funding any screening tests whatsoever and any research being done to develop new ones, and call it a day? That would be much more transparent, not to mention cheaper, than stifling preventive medicine in the painfully slow and deceptive way we are doing it today.

About Those Doctor-Nurses

DrRich | October 17th, 2011 - 6:32 am

Podcast:

A recent article in the New York Times discusses the growing controversy regarding whether nurses who have earned a doctorate degree in nursing practice ought to be addressed, by patients or others, as “doctor.”  The article touches upon several salient aspects of this controversy, but unfortunately does not resolve any of them.

According to the article, most doctors think nurses – even ones with advanced degrees – should not be awarded this honorific. Only physicians ought to be referred to, in any clinical setting, as “doctor.”

The reason, of course, is entirely altruistic. If the nurses are called “doctor,” it will confuse patients; they won’t know what’s going on, or who’s in charge. This kind of reasoning is entirely consistent with physicians’ well-known and unremitting efforts to make sure every patient understands exactly what is going on, at all times. Clearly, nurses calling themselves “doctor” will undermine such noble efforts.

There are other issues to consider. The Times portrays Dr. Roland Goertz, chairman of the board of the American Academy of Family Physicians (and presumably a doctor of medicine, but this is unspecified), as fretting that, should nurses be allowed to wrest control of the title “doctor” from the real doctors, the real doctors would experience a “loss of control of the profession itself.”

Dr. Kathleen Potempa, president of the American Association of Colleges of Nursing (and presumably a doctor of the nursing kind, but also unspecified) counters that nurses are getting doctorates not to take over the healthcare system or screw with doctors’ heads, but merely to boost their education and stay current. There is, she says, a lot for nurses to learn about these days.

But despite such soothing words from one of nursing’s luminaries, the Times notes that doctors remain alarmed. Nurses are really getting their doctorate degrees, physicians happen to know, to boost their credentials to practice independently – making their own diagnoses, initiating their own treatment plans, writing their own prescriptions, &c. Several states already allow them to do so. Louis J. Goodman, chief executive of the Texas Medical Association, is not fooled: “This degree is just another step toward independent practice.”

But the Times article ends with another demurral from Dr. Potempa: “Nurses are very proud of the fact that they’re nurses, and if nurses had wanted to be doctors, they would have gone to medical school.” (As if, DrRich can hear a few of his colleagues muttering, they could have gotten in.)

So, as DrRich says, the New York Times succeeds in rubbing some of the sore spots created by this controversy, but does not resolve anything. In fact, the article merely dances around the real issue, and leaves it entirely untouched.

You are therefore fortunate, Dear Reader, that you have DrRich to explain the whole matter to you. In fact, here are the six things you really need to know about the doctor-nurses controversy:

1) Nurses who decorate themselves with a doctorate degree in nursing practice have every right to refer to themselves as “doctor,” just as any other doctor in any other field has that right. DrRich was reminded of this fact several years ago, when he was severely admonished at a parent-teacher conference by his child’s history teacher for failing to address her as “doctor.” (This was after DrRich had ascertained that this person could probably not name a single event in American history that had occurred prior to 1860. But then, her degree was in “education,” rather than in the subject matter she taught.) And consider this: there are “doctors” wandering our streets whose degrees are in fields of endeavor whose names end in the word “Studies.” If these souls deserve to be called “doctor,” then nurses – who actually know a lot of very useful things – certainly do.

2) It is not the nurses’ fault that the doctors of old, when they finally became tired of being referred to as “barbers” or “chirurgeons,” and wanting a more distinctive name for themselves, commandeered the generic and widely-used title of “doctor.” No doubt they were very impressed with themselves at the time for having gained an education beyond that necessary to create a decent tonsure, but still. It is as if football players had decided to usurp the term “athlete” as referring only to themselves, and then complained when race car drivers began calling themselves the same thing. (The football players would have a point, of course, but on the whole their behavior would be unreasonable, not to mention unseemly.)

3) It seems just a tad disengenuous for physicians to complain because nurses calling themselves doctors might confuse some patients. Doctors themselves have not been particularly assiduous about disabusing their patients of various confusions. Doctors have yet to explain to their patients, for instance, that according to recently adopted precepts of medical ethics, they are obligated to covertly ration their medical care at the bedside. As a result, patients still think their doctors’ primary obligation is to them. This sort of “confusion” seems far worse, to DrRich, than a little confusion about who is a doctor and who is not. (Besides which, evidence suggests that many patients will always labor under the notion that all female health professionals are nurses, and all males are doctors – and so their confusion about who is who is pretty standard stuff.)

4) DrRich knows that you family practitioners out there have bigger things to worry about, but what the heck is the story with Dr. Roland Goertz*, chairman of the board of your professional society? Can it be he’s actually worried that nurses calling themselves doctors will lead to doctors losing control of their profession? What control is that? Gentlemen and ladies, you have elected a chairman who thinks that you family practitioners still have control of your profession! What are you people thinking?

____

*DrRich notes that Dr. Goertz is aptly named. The original, according to the Song of Roland, also sacrificed himself fighting a futile rear-guard action against vastly superior forces.

____

5) Dr. Potempa, president of the American Association of Colleges of Nursing, seems like a very reasonable person, and perhaps doctors (the physician kind) might be able to work with her. But DrRich has noticed that there are several different professional societies representing nurses, and some are less mild-mannered and less “reasonable” than others. The nursing organization which perhaps most directly represents those kinds of nurses whom doctors are most concerned about (i.e., nurses who become “doctors” and then want to be addressed that way) is the American College of Nursing Practitioners. The ACNP is much less demure than is Dr. Potempa’s organization about its long-term goals, which it has publicly expressed in a Strategic Plan published in 2005. Anyone examining this plan will note right away that it has been published in ALL CAPS, which, by tradition, indicates a shouting, in-your-face, screw-you sort of an attitude. In this manifesto, the ACNP states (among other things) that “INTERDISCIPLINARY NON-HIERARCHICAL TEAM CARE IS THE HIGHEST QUALITY OF CARE” (i.e., we’re not taking any guff, or orders, from you know-it-all doctors, rather we will practice as fully independent agents); and declares that their goals will not be met until nurses are “PRACTICING WITHOUT RESTRICTION IN EVERY SECTOR OF HEALTHCARE DELIVERY” (i.e., there are no limits to our scope of activity). Overall, this document is breathtaking in its breadth, straightforwardness, and attitude. This Strategic Plan, DrRich points out to his physician friends, reveals what the nurse practitioners are really up to.

And it’s just what you thought.

6) There is an overriding fact that renders all of the above entirely moot. It does not actually matter what doctor-nurses call themselves, or even that there is such a thing as doctor-nurses. It does not matter that the ACNP appears to be a predatory organization. It does not matter that Dr. Goertz may suffer from an acute lack of clues, or that Dr. Potempa seems like a nice lady.

None of this matters, Dear Reader, because Obamacare, the law of the land, has promulgated a new definition of Primary Care Practitioner. By law, today, physicians who practice primary care medicine, and doctor-nurses, and nurse practitioners (not to mention various other forms of non-physician medical personnel), are all PCPs. They are all equally qualified under the law.

It is a done deal. Only the details need to be worked out.

It is not convenient to acknowledge this fact. Primary care physicians and their professional organizations would rather not think about the implications. It means that the American Academy of Family Physicians is fundamentally an obsolete organization, as are its officials, such as Dr. Goertz. It means nearly the same for the American College of Physicians. Neither of these organizations is about to admit that. Furthermore, if this fact were to be acknowledged by the academic programs which are training our primary care physicians, they would become obligated to inform their applicants that the 8-10 years of medical training they are signing up for will place them in the same position, legally speaking, as a nurse practitioner (or, if they want to cushion the blow a little, as a doctor-nurse). This is truly an inconvenient truth. So it is being publicly ignored.

And so primary care doctors, and their professional organizations, go on pretending that the big issue facing primary care doctors is what these new-style PCPs will call themselves. And they are happy to fulminate about that issue to reporters from the New York Times. It seems safer than facing the truth.

But the truth is still the truth, and only the primary care doctors who face up to it will stand a chance of bucking the system, and maintaining their professional standards.

DrRich has heard several primary care physicians argue that their training is just so much better than the training of a doctor-nurse that it’s absurd to suppose those lesser professionals can offer equivalent care. This would certainly be true if primary care doctors actually did the things their training prepared them for. But if they continue following the path the system has laid out for them in recent years – avoiding the management of hospitalized, acutely ill patients altogether; seeing the outpatients who constitute their entire practice at a rate of one per 7.5 minutes; spending that 7.5 minutes making chits on Pay for Performance checklists from On High; sending anyone who actually seems a little sick to the emergency room or to a specialist – it is actually difficult to see what the big drop-off will be if doctor-nurses are doing the job.

When DrRich’s 15-year-old automobile displays some horrible new symptom, he wants a well-trained and experienced mechanic to diagnose the problem and fix it the right way. But if he’s only taking it to one of those 10-minute places for an oil change and a filter, it’s fine with him if the technician just learned the job last Tuesday from Stu. Primary care doctors have allowed themselves to be converted into Jiffy Lube. The training advantage they have over doctor-nurses matters less and less.

The Central Authority is assembling panels of experts to determine which medical decisions are to be made under which circumstances for which patients, and all it asks of doctors is to follow their instructions to the letter. Further, the Central Authority has determined that doctor-nurses will be very, very good at following those instructions – better than physicians, almost without a doubt. Indeed, the nurses’ lesser training – enough to allow them to recognize common conditions, and also enough to teach them that medicine is extraordinarily complex and there’s a lot they don’t understand and never will – is aimed at rendering them satisfied to comply with the directives handed down by panels of experts, and to be very thankful they can do so. Their reduced training is a decided advantage to the Central Authority.

To the Central Authority, the role of an ideal “practitioner” will be much better filled by a nurse, whose training is brief, to the point, focuses on following treatment plans, and is not burdened by centuries of professional pride and embarrassing oaths to dead Greek gods.

Primary care doctors who still value their professional pride, oaths, &c. had better light out for the territories while they still can, and quit worrying about the doctor-nurses (who soon enough will have big problems of their own).

Doctors need to face what is happening to their profession, and avoid getting distracted by battles over nomenclature. If they want to maintain their professional integrity, they will need to clearly distinguish themselves from the checklist checkers and the guideline followers, and demonstrate how the individual expertise and the personalized care they offer will be a big advantage to many patients.

If primary care doctors believe they really do add value to patient care over and above whatever nurses can provide, then they had better learn to articulate exactly what that value is. And once having articulated it, they will need to organize themselves to deliver and market that value, at a reasonable price, to the people they expect to pay for it.

And the “people they expect to pay for it” had better be their patients – because the Central Authority and other third party payers have made crystal clear precisely what they want, expect, and will tolerate from a PCP. What that is, of course, is complete compliance with central directives, and an end to the annoying expectations physicians have traditionally expressed for individual decision-making.

And as for those within the Central Authority, DrRich humbly suggests they carefully read the ANCP manifesto, and ask themselves whether the object of their affection, when finally won, is going to prove quite the demure, compliant little partner they’ve been pining for all this time.

A Regulatory Speed Trap Waiting To Be Sprung

DrRich | October 10th, 2011 - 7:07 am

Podcast:

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.

An Abject Apology

DrRich | October 4th, 2011 - 6:30 am

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DrRich deeply, humbly, sorrowfully and most abjectly apologizes.

When one fancies himself an ironist, a satirist, one must be very, very careful. The ironist attempts to illustrate the limitations of a point of view with which he or she strongly disagrees, by purporting to adopt that point of view, and then taking it to its logical and outlandish extremes, in order to demonstrate how absurd it is at its root. But the irony only works when the people who actually hold that absurd point of view would somehow be brought up short, or embarrassed, or angered by it.

“That’s not what we’re saying at all!” is the response the ironist hopes to elicit. Because once the opponents make that response, it then becomes their obligation to attempt to explain  exactly how their point of view does not logically lead one to such absurd, counterproductive, or stupid conclusions. And, if the ironist is correct, his opponents will be unable to do so, and will be left with name-calling, labeling, and vituperation – which, by any objective measure, is a form of capitulation.

And judging by the names he has been called, the labels that have been hung upon him, and the vituperations with which he has been pasted, DrRich has generally been quite satisfied with the results of his occasional attempts at irony and satire.

But his most recent effort has failed, and failed badly, and for this he is most grievously regretful.

For, no sooner had DrRich penned his most recent post patiently explaining why Governor Christie is simply too fat to run for president, than sundry Progressives (the very target of DrRich’s badly misjudged piece) began publishing exactly the same opinion, using the same arguments which DrRich had considered to be the fruits of irony. In fact, one or two of them actually predated DrRich’s publication date. (Had he known this, he would have aborted his effort altogether.)

Regular readers will know that DrRich has long railed against the demonization of obesity, and has liberally employed irony to do so. By ostensibly supporting those who would cast the spirits of fat people into herds of swine, DrRich has (until now, he thought) effectively shown the moral bankruptcy of the anti-obesity movement.

The anti-obesity movement, DrRich thinks, is like many of the crusades which have been taken up by Progressives (for instance, the environmental movement and the deification of “diversity”), in that it takes what at its root is a good idea (in this case, the unhealthfulness of extreme obesity), and converts it into a sledgehammer with which to beat the populace into compliance with top-down, expert-driven controls over individual freedoms.

It is an unavoidable result of publicly funded healthcare that any behavior of any individual which increases the likelihood they will need “extra” healthcare services, will potentially rob those of us who do not choose such unhealthful behaviors of medical services which might otherwise be available to us. Therefore, when healthcare is entirely publicly funded, it is inevitable that individual behaviors will need to be controlled by some Central Authority.

The obese are the chosen first target for asserting such controls. To render those controls publicly acceptable, it is necessary to reduce obese individuals to a state in which limiting their individual freedom of action is widely considered acceptable. That is, they need to be demonized.

So we ignore that gross obesity is almost always genetically mediated, greatly enhanced by environmental factors largely out of an individual’s control. We choose to blame obesity entirely on a lack of self-discipline, on a fundamental failure of the individual himself, and we behave as if this failure renders fat people beneath contempt. We do not do this with smokers, or drug abusers, and even seem reluctant to do it with child molesters. But fat people are fair game.

So when DrRich said that Governor Christie is just too damned fat to be a candidate for president, because fat people are lazy, slothful, lethargic, and self-indulgent; and because allowing a fatty to aspire to such a high position would create the false impression that obese people are worthy of any consideration whatsoever, and would make people think that the obese ought to have the same individual freedoms as the rest of us; and when DrRich concluded that Christie’s candidacy would therefore be a serious setback to the Progressive program (which is to say, controlling individual behaviors for the great benefit of the collective); and when he therefore urged the Governor to stay in New Jersey, except perhaps to occasionally cross the state line just long enough to stock up on Philly cheesesteaks; he thought he had taken the thing to the outlandish extremes customary to a master of irony.

So imagine DrRich’s dismay when, just after publishing his diatribe, he saw Michael Kinsley’s article on Bloomberg also declaring Christie too fat to be president. The reason? Because “a presidential candidate should be judged on behavior and character, not just on policies.” Fat people, Kinsley elaborates, are a “perfect symbol of our country at the moment, with appetites out of control and discipline near zilch.” In other words, fat people have shown themselves, by their very obesity, to be entirely unworthy characters, and being unworthy, should not aspire to the presidency  – or presumably, to any other position of importance.

Then there’s Eugene Robinson of the Washington Post, who agrees that Christie’s weight should prevent him from running, but does so for kinder reasons than Kinsley’s. Robinson is worried about the Governor’s health. That’s kind of him, but he also can’t help remarking that the “obesity epidemic” is costing the government a lot of money, and indeed, he implies that people like Governor Christie are responsible for the massive federal deficit. Since Christie is likely to remain fat whether or not he runs for president, when one parses Robinsons’ sentences one can only conclude that his real argument is that it would simply be wrong for a person whose behavior is costing us so much money, and is thus endangering the future of the nation, to aspire to the presidency.

So there you have it. Actual Progressives are making the very same arguments for Christie to stay out of the race that DrRich made, in what he thought was a brilliantly ironic blog post.

DrRich’s description of how the obese are regarded is no longer an outlandish extrapolation of prior statements and policies. It’s now official. The party line on obesity is this: Fat people have chosen to become fat, and by so doing, have overtly displayed, for everyone to see, their utter lack of discipline, self-control, self-regard, and concern for their fellow citizens. So the obese have no reason to expect the same rights, privileges, freedoms and considerations enjoyed by us thinner (or at least, less fat) citizens.

DrRich unwisely tried to satirize the Progressive position on obesity, without realizing that this position had already “progressed” well beyond irony. His readers ought to expect more from him than this, and so he abjectly apologizes.

DrRich only asks his readers to please take into account, when you consider the Progressives’ actual behavior and their own words, how very difficult it is becoming to satirize them. DrRich may soon be reduced to straight reporting.

Why Governor Christie Must Not Run

DrRich | September 30th, 2011 - 12:15 pm

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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.
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*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.
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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.

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*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.
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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.

 

In The Million Hearts Initiative, Cardiologists Need Not Apply

DrRich | September 26th, 2011 - 6:52 am

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It is a good thing that DrRich is not the only cardiac electrophysiologist writing in the medical blogosphere. If he were, the public would no doubt believe that all electrophysiologists are arrogant, self-important, sarcastic blowhards who insist on expressing themselves in the third person. Fortunately, that DrRich is uniquely afflicted in this manner, and that at least two out of three electrologist appear to be not only brilliant but also reasonably normal people, is nicely demonstrated by the offerings of Dr. Wes and Dr. John M on their respective blogs.

Both of these relatively socially acceptable electrophysiologist bloggers have seen fit to comment on the Million Hearts Initiative, recently introduced with great fanfare in the pages of the New England Journal of Medicine by Drs. Thomas R. Frieden, M.D., M.P.H., and Donald M. Berwick, M.D., M.P.P., on behalf of the United States Department of Health and Human Services. The Million Hearts Initiative aims to prevent a million heart attacks and strokes over the next five years.

The critiques of both Dr. Wes and Dr. John M regarding the Million Hearts Initiative are insightful and well-written, and both offer cogent analyses of the shortcomings of this program. DrRich strongly recommends both for your perusal.

Dr. John M is largely sympathetic with the aims of the Million Hearts Initiative, but finds that at least some of the methods proposed by DHHS to prevent all those heart attacks and strokes are unlikely to do much good. And more importantly, Dr. John notes, the MHI manifesto entirely ignores one of the most important (possibly THE most important) measures to reduce the risk of cardiovascular disease, namely, exercise. Dr. John M is an avid cyclist, and has personal experience with the benefits of exercise. How, he asks incredulously, can you design a major program to prevent cardiovascular events and leave out exercise?

DrRich (who, being a runner for going on five decades, has himself invested much blood, sweat and tears to the proposition that exercise is good for you), also finds this ommission to be quite remarkable. But as usual, DrRich has developed a theory to explain it. Both Dr. Frieden and Dr. Berwick, judging from the string of letters trailing behind their names, are public health experts. Public health experts are known for taking snippets of data from typically flawed clinical trials and, stringing together a chain of mathematical assumptions and conjectures longer than their post-nominal decorations, calculating how many people will be saved (or killed) if this or that public policy is initiated (or withheld). Obviously, for the Million Hearts Initiative, Frieden and Berwick needed to assemble a package of policy interventions whose calculations, when properly jiggered, show that there will be precisely one million beneficiaries. By including exercise in their program (and in their calculations), they would clearly have boosted the results to some awkward and difficult-to-promote value. The “One-Point-Eight Million Hearts Initiative” would just not have had the proper flair.

Like the President says, John, it’s just math.

Dr. Wes is somewhat less charitable toward these eminent public health experts than is Dr. John. John, while criticizing their methods, attributes high motives to them. Wes, on the other hand, is quite cynical about their motives. (In fact, if it were not for his total lack of blustery, third-person-y verbosity, Dr. Wes’ post might well have been written by DrRich.)

Wes suggests that the Million Hearts Initiative is the Feds’ way of distracting the public from noticing that they are doing everything they possibly can to restrict patients’ access to cardiologists, and to restrict spending on cardiovascular medicine.

It is, in fact, striking (at least to cardiologists like DrRich, Dr. Wes, and Dr. John) that this major policy initiative to save a million hearts has no place in it for cardiologists. Cardiologists are never mentioned in the manifesto itself, except obliquely to indicate that their services will not be required. Cardiologists, of course, take care of patients who have already developed significant heart disease. So what the public health experts are telling us is that they are only interested in stopping heart attacks and strokes in people who are apparently disease-free. There’s nothing wrong with that, of course. Preventive medicine is extremely important in cardiovascular disease.

But still. It is at least arguable that the quickest way to prevent a million heart attacks and strokes would be to target those patients who have the highest risk for these events, namely, people with known cardiovascular disease. Cardiologists dedicate their lives to preventing catastrophic events in these high-risk patients – and a tremendous amount of clinical evidence suggests they’re pretty good at it. While the only thing we ever hear these days about stents and implantable defibrillators is that cardiologists over-use them (and so the DOJ is launching criminal investigations to intimidate doctors into using them less frequently), when these kinds of technologies are used appropriately – as they most often are – they are proven to save lives.

But this is most decidedly not what the government’s public health experts are trying to prove. They want nothing to do with actual doctors practicing medicine in the trenches, fighting to save patients with active disease. Rather, they are out to show that the healthcare system can do just fine without all those fancy specialists and all their expensive procedures. They are aiming to advance the Progressives’ long-term agenda of showing that all the really important stuff in healthcare can be accomplished with much cheaper public health initiatives.

As DrRich has pointed out, it is our duty as citizens to maintain our wellness, and the the Million Hearts Initiative is simply the latest initiative by which the Central Authority will help us fulfill that duty. Those who by their own shortcomings develop heart disease or stroke, despite all the wonderful preventive help they receive through programs such as this, have manifestly failed  to fulfill their duty to society and will just have to get by the best way they can. And doctors such as cardiologists, who made the mistake of choosing careers dedicated to caring for such slackers, should not expect to be taken seriously, or overly respected, by the public health experts who are doing the really important work, or by any policy makers for that matter.

None of us cardiologists, nor our patients, should be surprised at being excluded from the Million Hearts Initiative. And won’t we feel bad when the results are in, and it turns out that millions of hearts can indeed be saved without any participation by the heart specialists?

So: Can the public health experts really save a million hearts with the specific steps they say they will take? Examining the strategy which Drs. Frieden and Berwick have laid out in their document, it certainly does not appear so. But, as it turns out, that result will be amenable to “tailoring,” and so the actual values they obtain in their results will be of little consequence.

The Million Hearts Initiative proposes to save a million hearts by doing the following:

A) Make “providers” report more regularly on how well they make little chits on checklists. (These are pretty much the same checklists the providers are already using; it’s the improved reporting standards that will save lives.)

B) Use electronic medical records to track and improve the behavior of providers and patients. (It is not clear exactly how this is supposed to work, though it is easy to imagine many rather spooky initiatives that might be taken, given the creation of a centralized database tracking, among many other intimate details, everybody’s long-term behavioral habits.)

C) Assemble groups of providers into “care teams,” which will somehow employ tag-team counseling efforts to get patients to improve their lifestyles. (Revealingly, it is this gang-nagging, and not novel life-saving technologies, which the public health experts refer to in their document as “clinical innovation.”)

D) Reduce smoking and second-hand smoke. (Fine, but this is merely one of the behavioral changes about which oppressed patients will be mercilessly “counseled” – see Item C.)

E) Get trans-fats out of the food supply. (DrRich has no objection here either, except to note that it was the same public health experts who, 40 years ago, demanded that trans fats be introduced into the food supply in order to crowd out saturated fats.  This is one example of why, when you’re a Progressive, history has always begun just 10 minutes ago.)

And F) Institute a population-wide salt restriction. (This amounts to yet another huge experiment to be perpetrated on the population at large. With luck, after 10 or 20 years this experiment may finally reveal who’s right – the experts who say that a general, population-wide sodium restriction will reduce net mortality, or the experts who say such a sodium restriction will increase mortality. Right now there’s plenty of data to argue for either outcome.)

Will doing these things really save a million hearts? Not in real life. All these things, taken together, don’t amount to very much in terms of actually accomplishing anything useful. But in the final analysis, the public health experts will have a decided advantage. It is plain that, while proving that hearts are actually “saved” by such measures will in fact be impossible, it will be equally impossible to disprove it. This situation is entirely analogous to the one in which the Administration insisted that President Obama’s stimulus package “saved” eight million jobs – since there is no way to prove or disprove that any jobs (or hearts) would have been lost had you done the other thing, any old claim is just as good as the next.  In such situations, the faction which gets to analyze the final data (in this case, those selfsame public health experts) can manipulate the statistical evidence any way they must to “prove” what they aim to prove.

Heck, they probably have their final report written up already.

Readers are advised to forget about saving a million hearts. Instead, save only one. Don’t smoke. Get plenty of exercise. And don’t eat so damned much. And should you develop heart disease despite your best efforts (which happens all too frequently despite what you’ve been told), pray that you can still find a cardiologist who has not been intimidated into withholding those expensive, modern medical therapies that really have been proven to save hearts, and lives.

Gibson Guitar and the Regulatory Speed Trap

DrRich | September 19th, 2011 - 6:25 am

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A couple of weeks ago, a swarm of Federal agents from the Fish and Wildlife Service, armed with automatic weapons, suddenly raided the Gibson Guitar Company and confiscated raw materials and finished guitars, apparently because Gibson allegedly violated the Lacey Act in their importation of exotic wood.  Spokespersons from Gibson insist that they purchased the wood legally, that the sale was approved by Indian authorities, and that they have the paperwork to prove it.

To DrRich, the interesting aspects of this episode are: a} The Jobs! Jobs! Jobs! Obama administration is happy to raid and disable a business – a manufacturing business at that – that has been hiring Americans, in order to enforce murky, difficult-to-interpret laws which require Americans to comply with even more difficult-to-interpret and even murkier laws in foreign lands. b) The administration is willing to enforce such laws in such a way as to induce maximum intimidation. And c), they are willing to do so selectively. (Several guitar companies, which have not been raided, also import the same wood from the same sources.)

DrRich stipulates that neither he – nor anyone else – knows all the facts of this case, and that perhaps Gibson really is guilty of imperfect compliance with the Lacey Act.  However, from what is known publicly, even if this were true, this episode would appear to be a case of selective enforcement. DrRich does not know whether the Administration would pick on Gibson because its CEO is a well-known Republican, or to teach a lesson to the people of Tennessee because at least one of their Senators has been seen consorting with the Tea Party, or because Gibson is non-unionized, or for some other reason.

The current version of the Lacey Act was arguably promulgated for good reasons, aimed as it was, ostensibly at least, at protecting rare species. But full compliance with the Lacey Act requires companies to document they are in full compliance with changeable, obscure and opaque laws in foreign lands, and in a fundmental sense is impracticable. America has many laws, rules, regulations, and guidelines that are just like this – for which it is, for all practical purposes, impossible to be in full compliance.

Such laws and regulations are very useful to the government, because it allows them to declare, at a time of their choosing, almost anyone who is functioning under those laws to be criminals. If Americans understand that the only thing standing between them and a raid by Federal agents armed with automatic weapons is the pleasure of the Central Authority, then smart Americans will do whatever they can to curry that pleasure.

DrRich calls it the Regulatory Speed Trap. The Regulatory Speed Trap can be recognized by its typical 5-step pattern;

1) Over a long period of time, regulators will promulgate a confusing array of disparate, vague, poorly worded, obscure and mutually incompatible rules, regulations and guidelines.
2) Individuals or companies which need to provide their products or services despite such hard-to-interpret regulations, will necessarily render their own interpretations (usually with the assitance of attorneys, consultants, and the regulators themselves), and will act according to those interpretations.
3) By their apparent concurrence with, or at least by their failure to object to, such interpretations of the rules, the regulators over time allow de facto standards of behavior to become established.
4) When it becomes to their advantage, the regulators will reinterpret the ambiguous regulations in such a way that the formerly tolerated de facto standards suddenly become grievous violations.
5) Regulators aggressively, but selectively, prosecute newly felonious providers of products or services.

Basic to the Regulatory Speed Trap is an underlying set of complicated and contradictory rules and regulations. In most instances, such as with the Medicare regulations that have evolved over the past several decades, the complexity and self-contradictions grow almost organically over time, and are not planned in any way.  In other instances – such as with the Lacey Act – some new regulations that cannot be complied with are created de novo. And in yet other circumstances – such as the Obamacare legislation or the Dodd-Frank legislation – an entire, massive, tangled web of impossible regulations is painstakingly created out of whole cloth. (This is likely why it is taking so long to render each of these new laws into their hundreds of thousands of pages of regulations.)

It is a rule of nature that bureaucracies evolve away from clarity and toward maximum complexity. But the resultant regulatory morass does not necessarily have to produce fatal paralysis. Societies have thrived for long periods of time despite such bureaucratic complexity. (The Byzantine Empire for instance, whose very name came to symbolize the bureaucratic tangle, lasted for a thousand years.) These societies have thrived, however, only because bureaucrats have allowed de facto interpretations and standards of behavior to develop under their watchful eyes. This sort of benign oversight permits societal commerce to continue to function within some reasonable bounds.

But the modus operendi of our Progressive leaders – in their perpetual attempt to establish the perfect society – is to control “everything” from the top down. And what they have discovered, to their unending delight, is that in a mature bureaucracy – one that has found a way to function despite a tangle of vague and contradictory regulations – is that Everyone Is Always Guilty Of Something.

And if everyone is always guilty of something, then the judicious use of the Regulatory Speed Trap, which is to say, the selective enforcement of inherently ambiguous regulations, becomes a useful tool for achieving Social Justice. By such selective enforcement they can punish their enemies (the enemies of the Progressive Program), reward their friends, and press their own agenda as they see fit.

This, DrRich submits, is what we see happening today to the Gibson Guitar Company, and for that matter, to Boeing.

Less obvious to the average citizen, but very obvious to individuals and organizations working within it, is that the same thing holds for the American healthcare system. Even before all the Obamacare regulations are published, the morass of already-existing rules, regulations and “guidelines” means that, at any given time, the Central Authority can suddenly construe some rule in such a way that virtually any worker or any institution dealing with the healthcare system becomes a criminal. The Central Authority has already exercised its awesome and arbitrary power to do so, in selected and circumscribed cases, and to good effect. Today, healthcare workers and institutions – and especially the medical profession – know that staying on the good side of the Feds is Job One.

Which means that doing what’s best for your patient can be no higher than Job Two*. It is not only “ethical” to act for the good of the collective instead of the individual patient, it is also the only way to optimize your chances of staying on the right side of the law – whichever law, that is, the Feds choose to reinterpret at any given time.

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*For doctors, doing what’s best for patients is actually Job Three. The top priority is maintaining your professional viability (by keeping the Feds happy); the second priority is protecting your turf against encroaching physicians from other specialties; and the third priority is the patients. This order of priorities does not mean that doctors are evil; if they ignore the first two priorities, they will not be able to do anything at all for their patients.
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Most doctors are very smart and can adjust to these or any other rules of engagement. It is the patients who are well and truly screwed by the Regulatory Speed Trap.

Is This The End-Game For American Doctors?

DrRich | September 12th, 2011 - 6:50 am

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Grand Rounds 7-50: The Jobs! Jobs! Jobs! Edition

DrRich | September 6th, 2011 - 6:59 am

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While Grand Rounds is normally the highlight of everybody’s week here in the medical blogosphere, this time it’s different. This week, we are all – each and every one of us  – completely distracted by the most wonderful sense of expectation and joy, to the exclusion of virtually every other human emotion. For DrRich, at least, the feeling puts him in mind of the giddy anticipation he experienced on, say, his 5th Christmas eve, when he was still young enough to consider Santa Claus a magical-but-real agent of earthly delights. (This was before DrRich realized that Santa, being obese, is actually a great menace to society.)

For this, dear reader, is the week when President Obama will turn his considerable powers of intellect, at long last, to the issue of jobs. The President indicated to us more than a month ago that he would, in his own good time, present to us his program for fixing the horrific and prolonged unemployment problem which now affects most American families in some way. And thus realizing that a solution is finally at hand, we in the great unwashed masses have waited, as patiently as we could, through earthquakes, hurricanes, Martha’s Vinyard vacations, and numerous pre-season football games, for the President to tell us the Answer. And, summoning together a Joint Session of Congress – a venue most often reserved for declarations of war and similar life-altering policy initiatives, thus confirming the momentous nature of his coming words – he will finally proclaim to us the Good News, a mere two days from now. One can cut the anticipation with a knife.

So, while it is indeed an honor to be hosting Grand Rounds during this historic week. DrRich must admit to finding it a little difficult to concentrate his efforts. No doubt readers will likewise find it a challenge to turn their attention away from the Big Event long enough to peruse the following posts – the best of the medical blogosphere this week.

But be assured that there is good stuff to follow. So, if you find yourself incapable of focusing your attention on Grand Rounds at the moment, simply bookmark this page, and return to it once your sense of soaring happiness returns (as it inevitably must) to a more normal state. Be assured that this week’s entries are timeless enough to outlive your ecstasy (an emotion which – alas! – to be effective, must always be transient).

So let us begin.

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DrRich – having been informed not long ago, by an actual U.S. Attorney who at that moment had him under a form of official duress, that the DOJ is well aware of this blog and the general tenor of its content – always likes to mention early in any long post (so that his minders do not have to read the whole thing) any items that might be helpful to the Administration. Accordingly, we open Grand Rounds this week with the announcement, posted in The Examining Room of Dr. Charles, of the 2011 Charles Prize for Poetry. Dr. Charles has been hosting this prestigious contest – which seeks and awards excellence in poetry touching on health, science or medicine – for some time now, and it has proven to be an exceedingly popular annual event.

In addition to the significant intrinsic merits that accompany the Charles Prize for Poetry, DrRich must note that Dr. Charles is also awarding a not-inconsiderable cash prize to the winners. That is, he is creating what, in our present economic environment, must be considered damned-near jobs. Encouraging employment in the career of poetry is something, DrRich thinks, the President should seriously consider before Thursday night, lest he be tempted to make the huge mistake of attempting to whip up enthusiasm yet again for Green Jobs. (In the wake of the collapse just last week of the heavily-government-subsidized and heavily-Obama-promoted Solyndra Company, and of at least two other companies that received large federal funds for Green Jobs, treading that dead ground again would merely reveal that he is entirely bereft of ideas.) The Administration ought to thank DrRich, and especially Dr. Charles, for this critically important advice. Encouraging poesy, instead of Green Jobs, would demonstrate the kind of new thinking we are all looking for from our President at this critical juncture.

At Dr. Malpani’s Blog, Dr. M. outlines his 3-step approach for helping his patients understand the intricate concepts of in-vitro fertilization. First, you describe how the thing is supposed to work when everything is functioning normally (the “thing” in this case being the human reproductive system). Then, you describe to the patient where the system is breaking down in his/her case. And finally, you describe the options available for mitigating the breakdown. Dr. Malpani’s system, which he points out is generalizable, is aimed at creating a consensus for action when faced with a complex problem.

DrRich will only remark that Dr. M’s system, which works well enough for problems based in human physiology, is proving pretty worthless for problems based in the more social sciences, such as economics. This is because of a fundamental disagreement, among the debaters, on how the economy is “supposed to work when everything is functioning normally.” Progressives and conservatives have very different ideas about this. So Dr. M’s approach, which requires both logic and a fundamental consensus on what constitutes “normal” behavior, is unsuitable to non-physiologic systems.

Dr. Val at Better Health posts a recent interview with Dr. Dori Carlson, president of the American Optometric Association, regarding the importance of screening children for subtle but significant vision problems. (Dr. Val and Dr. Dori are referring here to the kinds of vision problems that involve optics, and not the kind suffered by our political leaders.) The type of gross vision screening which is conducted by most schools misses the majority of these vision problems in children, and those undetected vision problems not infrequently lead to impaired learning. Also, they often lead to misdiagnoses and inappropriate treatment, likely including the misdiagnosis of ADHD. (Missed vision problems constitute only one of the causes for the explosion in ADHD diagnoses in recent years. A more common cause, in our overly-feminized schools, is being a boy. Indeed, as nearly as DrRich can tell, being a boy today is a disease; they have drugs for it and everything.) In any case, if you are a parent of a school-aged child, you should strongly consider having your child’s vision checked by an ophthalmologist or optometrist – especially if somebody wants to put him on Ritalin.

Henry Stern at InsureBlog tells us the good news and bad news about a new study related to heart attacks. He notes that heart attack victims are receiving definitive therapy in American hospitals much more quickly than they were just a few years ago. And when you are having a heart attack, minutes count – the longer that coronary artery is occluded, the more permanent damage is done to your heart, and the higher your odds of death or disability. So the diminished delay to treatment is good news. As usual, though, there is bad news attached. DrRich, always the sunny optimist, does not wish to repeat the bad news. You can go to the InsureBlog to read it for yourself.

The ACP Internist reports a study showing that 80% of today’s doctors look up on-line information in front of their patients. DrRich, who admits to being an Old Fart, does not find this surprising, since young physicians these days are, well, young. And young people are on-line all of the time, reporting their every trivial thought and mundane action instantaneously to the Cloud. (If Andy Warhol were alive today he’d be talking about our 15 minutes of anonymity.) But you don’t have to be a young doctor to take up these new habits. It appears from this new survey that doctors of all age groups have ritualistically placed an LCD screen between themselves and their patients. In so doing, they have awarded to those distant, expert panels – the ones spinning out all those guidelines, pay-for-performance checklists, marching orders, &c – their appropriate and rightful physical position, that is, directly interposed between doctor and patient. This is more than mere symbolism, but the symbolism is delicious.

But, dear reader, please do not be too critical of today’s doctors. If you yourself were a savvy modern physician, realizing that you could go to jail if you do what you think is medically appropriate before checking with the Authorities to find out if it is also allowable, you’d have a computer screen in front of your face too, and you’d be looking stuff up in front of your patients the entire time they were blathering on about their symptoms or whatever. DrRich worries for the 20% of doctors (likely, his fellow Old Farts) who haven’t “gotten it” yet.

Beth Gainer at Calling the Shots makes an important observation about the two classic narratives to which all victims of breast cancer are assigned – the narrative of the triumphant hero, and the narrative of the courageous and noble victim. Ms. Gainer’s observation is that most women with breast cancer do not fit either of these prescribed narratives. Many women are thus left feeling guilty or diminished when they find that their experience is not meeting with society’s expectations. Ms. Gainer is absolutely correct, and indeed, her observation is generalizable. The same thing occurs whenever society’s designated narrative-makers assign a range of permissible attitudes, thoughts and behaviors to any defined group. Mercy on any member of the group who falls outside those designated norms.

David E. Williams at the venerable Health Business Blog addresses the question of how we – society – will cope with the next big trend in the drug industry – the development of “niche” drugs, drugs that are suitable for only a relatively small number of patients and which, therefore, are exceedingly expensive to develop and market. David goes directly to the real question – the problem of niche drugs makes the issue of healthcare rationing unavoidable.

So far, of course, we are doing our healthcare rationing covertly, and in the case of niche drugs that usually means interpreting clinical results in such a way as to minimize their potential benefits. We do this by saying that Drug X “only increases survival by 4 months,” and ignoring the fact that “4 months” is an average value, and that while many patients have no benefit at all, a non-negligible minority may live a lot longer. The question, “Is it worth $50,000 for only four more months of life?” is different from the question, “Is it worth $50,000 to have a realistic shot at living several extra years?” Covert rationing causes us to frame the question in such a way that the answer to any question beginning with “Is it worth. . .” is always, “no.”

At the Road to Hellth, Douglas Perednia, one of the best analysts of health policy writing today, looks at the rationale for the onerous penalties which are required under Obamacare for hospitals whose patients are readmitted at higher than the average readmission rates. Perednia describes the bogus math which the Feds are apparently using to determine what appropriate readmission rates ought to be – and points out the irony of requiring doctors to behave in an “evidence-based” fashion, while the Feds themselves are using frivolous statistics to dole out the equivalent of the NCAA Death Penalty to our hospitals.

Steven Seay, PhD discusses what ought to be second nature to any clinician – applying the principles of the scientific method to clinical practice. That is: gather the necessary data to formulate an hypothesis; institute therapy based on that hypothesis; measure the results of that therapy; revise the hypothesis to reflect this new data; repeat as necessary. This is the way clinical practice should be done. DrRich is happy to learn that it is still apparently OK for clinical psychologists to function in this manner. For physicians, especially PCPs, the scientific method has become forcibly compressed to: make a diagnosis; treat according to the guidelines. While the patient might not do so well with this new method, the physician will be OK, since “quality” will be measured according to one’s compliance with the guidelines. Measuring the actual results of the treatment, of course, would only lead to trouble, and in most cases will be avoided.

James Gault, MD, of the blog Retired Doc’s Thoughts, is a long-time champion of classical medical ethics (as opposed to the New Age medical ethics now formally espoused by all the major professional organizations).  As such, Dr. Gault often deconstructs arguments being published by modern medical ethicists supporting these New Age ethics, which require doctors to act for the benefit of the collective rather than for the benefit of their individual patients. In this post, Dr. Gault gives a very effective what-for to Professor Fuchs of Stanford, who, once again, has published a paper advancing the bankrupt argument that what’s good for the collective is necessarily good for the individual. These kinds of vapid arguments may fool the Whippersnappers, but they’re not fooling us Old Farts.

The ACP Hospitalist notes that, according to the Institute for Safe Medication Practices, a “grey market” is developing for life-saving medications that have been in severe short supply for the past few years. A grey market, DrRich thinks, is like a black market, but less illegal – though it is possible they are referring to Old Farts who are merchants. In any case, the ISMP says the grey market is price-gouging hospitals that need those important drugs, and have nowhere else to buy them. The solution, according to the ISMP, is (among other things) to empower the FDA to manage drug shortages and tighten regulations for drug distribution.

The growing, widespread shortage of important medications is indeed a bad problem. We should look for a solution to this problem. Shortages of any product occur when it costs companies more to make the product than they can get for it in the marketplace. Onerous regulatory policies by the FDA which, in the name of product safety, have greatly increased the cost of doing business for pharmaceutical companies, along with recent de facto price controls on generic drugs, have combined to make it economically unfeasible for drug companies to expend large resources to manufacture these drugs. It seems doubtful that piling on even more regulations will improve the situation. And attacking the grey markets will simply drive them further into the dark (since black markets are nature’s way of providing a product when governments act to limit it). Given the expected 500,000 pages of new regulations being conjured up out of the Obamacare legislation, drug shortages are merely the first of many critical medical shortages we will be seeing in the coming years. So it will be instructive to watch how our leaders handle this problem.

In any case, from the job-creation standpoint, DrRich believes there will be many employment opportunities in coming years in sundry black markets related to healthcare. Many skills will be needed, some of which should be quite exciting!

At the Prepared Patient Forum, Trudy Lieberman writes a post entitled “Health Insurance, Meet the Jolly Green Giant,” in which she discusses the new, patient-friendly labels that are supposed to accompany health insurance policies under Obamacare beginning no later than 2014. The labels sound like a good idea, but as Ms. Lieberman points out, there will be problems. For instance, for the Feds to mandate transparency in labeling is unlikely to be all that helpful when, at the same time, they often mandate utter secrecy on the part of providers (for instance, in creating severe anti-trust penalties for doctors who reveal the fees they have negotiated with insurance carriers). But as always, results are far less important than simply meaning well.

Sharp Incisions, a blog written by a self-described “fledgling” medical student, has sent in an affecting post about scrubbing in on a unique surgical case – the harvesting of six vital organs for transplantation from a patient who has been declared brain dead. DrRich prays that Dr. Incisions will maintain for a long time the same sense of wonder and gratitude, expressed in this post, for the gift of life.

A medical student who blogs anonymously at the D.O.ctor Blog, describes her first experience participating in cardiopulmonary resuscitation when it actually counted. DrRich, who in his days as a cardiac electrophysiologist ran hundreds of these things, and who became convinced over the years that three people was the optimal number to run a “code,” admits to being a little taken aback by this student’s description of the event, which sounds like it must have been as complex to coordinate as a Busby Berkeley production number. No wonder she was a little astonished by her experience. DrRich supposes that this must be the new-style CPR mandated by some new guideline or other, and would not be surprised to learn later this week that CPR procedures requiring 15 participants is part of the President’s new Jobs Plan.

Speaking of sudden death, one of DrRich’s recurrent themes here on the CRB is that sudden death is a great boon to our healthcare system (since not only is sudden death itself very cheap, but also it tends to remove individuals who would otherwise continue collecting Social Security, and who tend to have expensive chronic heart disease), and that therefore the government will tend to stifle the prevention of sudden death any time it can. Accordingly, Dr. Wes tells us that the Feds are about to further limit the use of the Zoll wearable defibrillator. Doctors have taken to using this device in high-risk patients during the first month or so after a heart attack, since guidelines specify that ICDs (implantable defibrillators) must not be implanted during this interval. Since sudden death is particularly likely during that first month, the Zoll device is being used as a “bridge to ICD.” Obviously, sudden death being the healthcare system’s friend, this must not be permitted. And so, Dr. Wes points out, soon it will not be.

At the HealthAGEnda Blog of the John A. Hartford Foundation, Marcus Escobedo describes how his father is coping with the decisions that need to be made as he deals with recurrent prostate cancer. Helping elderly patients deal with health issues is the thrust of Mr. Escobedo’s work at Hartford, and his new personal experience, he tells us, drives home the point. Specifically, Escobedo works to assure that elderly patients are considered to be more than just the sum of their disease and their age. DrRich is sorry to have to point out that no less an expert on American healthcare than President Obama has explicitly disagreed with this approach, and on national television to boot. Perhaps when he said this the President was suffering under the influence of teleprompterpenia, and perhaps if he had an opportunity to meet with Mr. Escobedo over a beer in the Rose Garden, he would possibly begin to revise his position to one that is more compatible with the mission of the Harford Foundation. On behalf of America’s Old Farts, DrRich would certainly hope so.

Dr. Thomas Pane writes in the Business, Surgery & Medicine Blog about tantrums, specifically, the kind occasionally thrown by surgeons in the operating suite. His post carries an important Labor Day lesson for anyone who hopes to make a career in the medical field in the coming years, so pay attention:

Everyone can agree that throwing tantrums in the operating room is never a good thing, and that quite often, it is a very bad thing. But Dr. Pane points out that, counterproductive as tantrums often are, they are nonetheless not the worst possible way in which a surgeon can express his/her utter frustration at a bureaucracy that blithely conspires to disrupt surgical procedures at critical moments. He reminds us, once again, that the biggest handicap one can ever have when working in an environment in which bureaucratic mud has fouled every gear is: giving a sh*t. So, while Dr. Pane may or may not agree, here’s the lesson: If surgeons would simply adopt the apathetic, indifferent attitude that classically characterizes long-term survivors in work environments mired by bureaucracy, all would be well.

Jaqueline writes Laika’s MedLiblog, a blog dedicated to medical information science. She submits a post entitled, “PubMed’s Higher Sensitivity than OVID MEDLINE… & other Published Clichés,” in which she shows how medical researchers doing literature searches for, among other things, meta-analyses, will stumble upon various “anomalies” in their searches of the PubMed and OVID databases, and then write additional, CV-padding papers about those anomalies. Jaqueline points out that these so-called “anomalies” are actually well-documented “clichés,” which are well-known to information specialists and anyone else who is competent in doing comprehensive literature searches. In other words, Jaqueline has documented that these meta-analysis researchers are rank amateurs at doing the most critical step in conducting meta-analyses – searching the literature for all the appropriate published studies. DrRich has always mistrusted meta-analyses, and Jaqueline has helpfully identified yet another reason to justify such mistrust. He thanks Jaqueline, and whoever planted those database anomalies which allow us to identify potentially incompetent meta-analysis researchers.

Nicholas Fogelson of Academic OB/GYN writes about taking care of the dying Jehovah’s Witness patient, or rather, taking care of the Jehovah’s Witness patient whose illness is potentially curable but who is dying because he or she refuses to accept blood products. DrRich can attest to how very difficult it is for a doctor to respect a patient’s religion when doing so results in their death. Dr. Fogelson’s description of his evolving attitude regarding this dilemma is compelling.

Need to be uplifted after reading the above post? Read Jordan Grumet’s submission from his blog, In My Humble Opinion. It’s brief and beautifully written, and it reminds us that sometimes our efforts as doctors – which all too often seem futile – can pay off in unimagined ways.

Pranab at the Scepticemia blog points to a news story about a medical school in Mumbai selling seats (that is, entry to medical school) to the highest bidder. He strongly objects to this practice, even though he postulates that his objection will make some of his readers call him “a leftist commie” (which DrRich finds to be the most common kind). DrRich does not agree with Pranab’s (tongue-in-cheek) conclusion that it is America’s fault that Mumbai medical schools are selling seats. (It is actually only George Bush’s fault.) But DrRich does agree entirely that the practice itself is an abomination. Indeed, we can all agree that entry to any career which requires a high degree of skill, talent, and/or intelligence ought to depend on merit, and nothing but merit. Can we not? Good.

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DrRich will end by noting that he is finishing this Jobs! Jobs! Jobs! Edition of Grand Rounds during the waning moments of Labor Day, which causes him to fondly recall those long-ago days of yesteryear, when the U.S. still had plenty of steel mills and DrRich was a card-carrying member of the United Steelworkers of America, and the thought of attending medical school had not yet penetrated his still-empty head. And he recalls how, while he was working one day as a lowly laborer, a union boss came over to him to explain (after DrRich had complained about it) the utility of his spending three painful days moving a large pile of slag, employing only shovel-and-wheelbarrow technology, from one location to another – AND THEN BACK AGAIN.  Now, those were the days when we knew how to make jobs!

Say, whatever happened to those steel mills, anyway?

Eliminating Waste and Inefficiency Is Not Enough

DrRich | August 29th, 2011 - 7:22 am

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A recurring theme of the CRB is that the rising cost of healthcare is the main internal threat to the continued viability of the US. Indeed, the very title of this blog reflects the chief mechanism which is being employed, fruitlessly and disastrously, in the attempt to reduce those costs.

Recently, DrRich pointed out that there are four ways – and only four ways – to reduce the cost of healthcare. He did this as a service to his readers, so that when politicians describe in their weaselly language how they will get the cost of healthcare under control, you will be able to figure out which of the four methods they are actually talking about.

While DrRich’s synthesis has been generally well-received, a few readers did offer one particular objection. DrRich, they assert, left out a fifth way to reduce the cost of healthcare, and the very best way at that. Namely, just get rid of the waste and inefficiency.

DrRich has talked about this before, but obviously it is time to revisit the issue.

It is, in fact, a central assumption of any healthcare reform plan ever proposed that we can get our spending under control simply by eliminating – or at least substantially reducing – the vast amount of waste and inefficiency in the healthcare system. Conservatives propose to do this by incorporating the efficiencies of the marketplace, thus eliminating the waste and inefficiency imposed by bureaucrats. Progressives propose to do it by adopting and enforcing strict, top-down regulations (ideally, through a single-payer system, employing the officially-perfect wisdom of various expert panels) that will control the wasteful and inefficient behaviors of healthcare providers. But one way or another, each scheme for reforming healthcare proposes to bring spending under control by eliminating waste and inefficiency.

Another way of describing what all the reformers across the political spectrum are telling us is: There is so much waste in the system that we can avoid healthcare rationing by getting rid of it. Most Americans believe this. Most policy experts believe this. DrRich suspects that even most of his loyal readers believe this, despite what he’s been telling you for many years.

But this is unfortunately false. No matter how much waste and inefficiency you think might be gumming up our healthcare system today, there’s not enough to explain the uncontrolled rise in healthcare spending we have been seeing for decades, and therefore, not enough to allow us to avoid rationing altogether in any publicly-funded healthcare system.

To understand why this is the case, we must first recognize the fundamental problem with our healthcare spending. The real problem is not simply that we’re spending a lot of money on healthcare, or even that we’re spending a larger proportion of our GDP on healthcare than any other country. The real problem is that our healthcare expenditures for years and years have been growing at double digit rates, several multiples faster than the overall inflation rate, such that, over time, an ever larger proportion of our annual GDP is being consumed by healthcare expenditures. Unless this disproportionate rate of growth is stopped, eventually healthcare spending will consume our entire economy. (Rather, what will actually happen is that it will grow to the point of producing societal upheaval, sending us back to a more typical era for mankind, where healthcare is a little-thought-of luxury, and not a necessity or a right. This will happen well before healthcare consumes 100% of the economy.)

To reiterate, it’s not the amount of spending on healthcare that is creating a fiscal crisis, it’s the rate of growth of that spending.

Once we understand the problem – that it’s the rate of growth of healthcare spending that threatens our society – then demonstrating that waste and inefficiency cannot possibly account for that rate of growth is a matter of simple mathematics.

What our politicians and policy experts are telling us, when they say they can fix the problem by eliminating waste, is that without all the waste, our healthcare spending would be economically well-behaved. That is, save for the waste and inefficiency, the annual rate of increase in our healthcare spending would be roughly the same as the general rate of inflation. To say it another way, our leaders are asserting that the “excess” in growth of our healthcare spending is entirely wasteful.

It is trivial to construct a simple spreadsheet to test this assertion, that is, a spreadsheet in which calculations assume that any increase in annual healthcare spending over and above the general rate of inflation must be due to wasteful spending.  In such a spreadsheet, for instance, we may take the annual rate of growth of healthcare spending to be 10% (a reasonably representative number for the past 30 years or so), and the annual rate of overall inflation to be 3%.

We now must “pick” the proportion of healthcare spending that we designate as being wasteful in Year 1 of our spreadsheet. Nobody really knows this value, especially since we all will define wasteful healthcare spending in different ways. Let’s just say, arbitrarily, that 25% of healthcare expenditures are wasteful in Year 1.

When we plug these values into our spreadsheet, the result is clear. In order to account for our unsupportable growth in healthcare spending by invoking waste and inefficiency, the proportion of healthcare spending that is caused by waste must increase to ridiculous proportions very rapidly, such that (for instance) by the Year 10 we will have more than doubled (59%) the proportion of all healthcare expenditures that are wasteful; and by the Year 20, nearly 80% must be wasteful. Similarly, the proportion of the annual increases in healthcare spending that would have to be due solely to waste and inefficiency rapidly climbs to equally ridiculous proportions. By Year 5, wasteful spending will have to account for 82% of the annual increase in healthcare expenditures, and that proportion continues to climb, eventually approaching 100%.

In real life, of course, we have enjoyed healthcare inflation of roughly 10% for over 30 years now. So if the assumptions behind our spreadsheet are accurate – and again, these are the assumptions our political and policy leaders expect us to swallow – we find ourselves in the position, at Year 30, where well over 90% of all of our healthcare expenditures must be wasteful, and virtually all of the annual increase in healthcare spending is entirely accounted for by waste and inefficiency. (This result is largely independent, after 30 years, of whatever value we may have chosen as the proportion of wasteful spending in Year 1.)

Such a result is completely absurd. If you think it is not absurd, but actually reflects reality, then (all of healthcare being entirely useless) there’s no point in worrying about healthcare at all – we should simply stop spending any money on it.

And this result indicates that the initial assumptions must be wrong. That is, the unsupportable rate of growth in our healthcare spending cannot be due to waste and inefficiency. Therefore, that growth must be due, fundamentally, to the growth of “useful” healthcare expenditures.*

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*This analysis does not trivialize the waste and inefficiency we actually see in our healthcare system, which is large and inexcusable. What it likely means is that the level of inefficiency – which is certainly at least 25% of the total if not higher – likely attaches itself proportionately, sort of like a tax, to the underlying growth in healthcare expenditures.
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Therefore, DrRich has demonstrated, using actual Math, that a substantial proportion of our growing healthcare expenditures must necessarily be coming from real, honest-to-goodness, useful healthcare. And if we’re going to substantially curtail that growth, we’re going to have to curtail useful spending. Which means that as long as we have publicly-funded healthcare (which we do), we have to ration.

But, once again, we’re Americans and Americans don’t ration. Which is why we commissioned first the big insurers and then the government to do the rationing covertly, a task they have accepted with great gusto.

DrRich is compelled to point out, once again, that waste and inefficiency is multiplied with great exuberance any time you have covert rationing. Disguising all the rationing activity as something other than rationing fundamentally requires opaque procedures, unnecessary complexity, bizarre incentives, Byzantine regulations arbitrarily and variably enforced or ignored, and the diversion of healthcare dollars to non-healthcare ends (such as corporate profits, expanding layers of government bureaucracies, and other massive bureaucracies within the healthcare system created to defend oneself against those government bureaucracies). Covert rationing greatly increases waste and inefficiency, and does so inherently and systematically.

To reduce the unavoidable rationing to the smallest amount possible, we will have to figure out a way to do it openly, and not covertly. Having viewed commercials featuring Congressman Ryan pushing elderly ladies off a cliff after he proposed a Medicare reform far less drastic than open rationing (a reform that would restore some individual responsibility for healthcare expenditures to at least some of the more well-off beneficiaries, and thus reduce to some extent the need to ration care), DrRich doubts whether the public is yet ready to engage in such an endeavor.