Are Medical Screening Tests A Bad Idea?

DrRich | October 31st, 2011 - 6:08 am

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Just last week, DrRich wrote a post explaining why medical screening tests, under our new paradigm of centralized healthcare, will always be found to be ineffective and harmful. Therefore, it will be the job of the United States Preventive Services Task Force (USPSTF)*, after making a great show of examining randomized clinical trials as if the result is not a foregone conclusion, to declare such tests useless.

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*Regular readers will recall that the Obamacare legislation has transformed the USPSTF from its former status as a mere (one might say milquetoasty) advisory board, which made recommendations on preventive health that doctors and patients could take or leave alone, into an extraordinarily powerful GOD panel (Government Operatives Deliberating) that determines, definitively, which preventive services are to be covered and not covered by private insurers, Medicare, and Medicaid.
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DrRich thought his observation would be viewed by many as a bit “out there,” and that proponents of Obamacare would accuse him (as they so often do) of being paranoid and reactionary. So imagine his surprise when, just yesterday, the New York Times published a “news analysis” which aggressively begins selling the public on that very notion – that medical screening tests are, by and large, a bad thing to do.

Even DrRich thought the Progressives would be somewhat circumspect about breaking such remarkable and counter-intuitive news to us in the great unwashed – especially considering that they have just spent the last three decades teaching us just the opposite.  But then he recalled their smooth, unapologetic and entirely unremarked transition, around twenty years ago, from sounding the alarm about global cooling to catarwauling about global warming.

And he reminded himself that when you are a Progressive, history always began 10 minutes ago.  And this turns out to be a great convenience.

In this case it is particularly convenient, when you consider the passionate declarations by Ms. Pelosi and others in 2009 that the watchword of Obamacare – indeed, the very key to the dramatically lower costs we would realize with this new legislation – would be “prevention, prevention, prevention.”

It is always risky to speculate on what is actually going on in Ms. Pelosi’s head, but certainly the public health experts who helped devise Obamacare understood the truth all along.  Namely, it is axiomatic that medical screening tests will always, without exception, cost the healthcare system far more money than they can ever save the healthcare system. And therefore, medical screening tests will have to be suppressed – which is precisely why our new healthcare law provides the mechanism for doing so.

While readers should never doubt DrRich, he is aware that, sadly, many do.  And so it may be necessary to review why screening tests are invariably a money-losing proposition:

  • The screening tests themselves are often expensive.
  • Screening tests often produce false positive results, so additional (often invasive and always costly) testing will need to be done to confirm or deny the diagnosis.
  • If the diagnosis is made, treatment will be applied which is often dreadfully expensive.
  • The diagnostic testing is often “too sensitive,” such that it may make a positive diagnosis for a very early condition that, if it had been left alone, may not have done serious harm. The cost of treatment will therefore be wasted.
  • The screening test, the confirmatory tests, and the treatments that will be applied as a result of screening all carry the risk of complications, and the treatment of these complications can be extraordinarily costly.
  • If the patient’s life is saved by the screening test and subsequent therapy, that patient (who is often an Old Fart like DrRich) will persist, for several more years, to soak younger, worthier Americans for Social Security and Medicare payments; and worse, will ultimately develop some other expensive medical problem everyone else will have to pay for.

Q.E.D.

The fact is, the best we can hope for from medical screening tests is that they might save a life here and there, which is hardly a public health victory. But whether they save a few lives or not, they’re inevitably going to cost us a lot of money.

And clearly, from the public health standpoint, a standpoint from which we’re paying for all healthcare collectively from pooled resources (and working hard to deny people the legal right to spend their own money on their own healthcare), it makes no sense to do screening tests.

Screening tests only make sense to the individuals who are at risk for the medical condition being screened, not to the collective.

The New York Times goes on at length to explain how screening for early cancers causes harm and inconvenience for many people in order to help a few. It mentions several of the points in DrRich’s bullet list above. It quotes several public health experts who, shaking their heads sadly, allow as how perhaps the medical profession has “oversold” screening tests in the past decades. These experts lament the fact that the public will need to be re-educated about the limitations and the harm being done by these tests. The Times worries that, perhaps, people will think the new de-emphasis on screening tests is related to healthcare costs, when nothing could be further from the truth.  The worthlessness of screening tests is a new revelation, made clear by recent clinical trials. What can we do but follow the science?

DrRich is not arguing that medical screening tests are invariably a good idea. In fact, he has just given his readers an entire list of reasons they are often not a good idea.

What he is arguing is that the whole framework for our current debate over screening tests is wrong.

The proper way to deal with the imperfections of screening tests is as follows. We should carefully explain to each individual who is a candidate for screening (because they are at risk for the medical condition being screened), all of the risks of embarking on a screening pathway – the potential discomfort, inconvenience, medical risks, and costs of the screening test, of the possible follow-up tests that may be required, and of the treatments that may become necessary if the testing is positive.  The individual can then weigh these negatives against the possibility of failing to discover a treatable disease while it is still treatable. And, taking into account everything that people take into account when making such momentous personal decisions, the individual can do what they believe is right for them. And either decision – to have or not have the test – would be reasonable, rational, and evidence-based – for that individual.

But we are arguing this question as if taking individual preferences into account is not even on the table. We are arguing as if we must make a sweeping decision regarding screening – yes or no – that will apply across the board, to all Americans, regardless of how they would personally weigh the relative risks and benefits.

We are arguing in this way because that’s precisely the approach that Obamacare has codified into law.  Medical decisions from now on will be centralized, and not individualized.  The GOD panelists will determine which decision is best for the collective. And what’s best for the collective is best for us individuals.

But the “screening test debate” graphically illustrates a truth that modern medical ethicists at least implicitly (and often explicitly) deny: What’s best for the collective is NOT always what’s best for the individual. And when we must only make medical decisions collectively, individual Americans will be systematically harmed. And that includes, according to the USPSTF’s own documentation, several thousand women and men each year whose early, currently treatable, but ultimately lethal breast and prostate cancers will no longer be detected early enough to do any good.

DrRich thinks these individuals should be given the opportunity to consider their options regarding medical screening, and make the choice that’s right for them. Progressives – especially the GOD panelists, the public health experts, and most of the American media  – do not.

That’s the debate we should be having.

Some Implications Of the New PSA Recommendation

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

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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?

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*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.

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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

Podcast:

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.