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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.

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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.

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As DrRich has noted many times over the years, “preventive healthcare services” cost the healthcare system far more money than they can ever save, and for this reason, any healthcare system engaged in covert rationing is going to have to find a way to stifle these preventive services.

Now, dear reader, before you go away angry, DrRich understands that some preventive measures are indeed very cost-effective. In fact, DrRich will now engage in a bit of cost-effective preventive healthcare: Don’t smoke. Don’t eat so damned much. And get some exercise.

There. DrRich has just successfully administered pretty much all of the truly cost-effective preventive measures known to modern medicine. (And it’s only cost-effective because the advice was free.)

All the other preventive stuff we do in medicine tends to bend the cost curve in the wrong direction.

Reasons that preventive healthcare services increase the cost of healthcare include: a) The preventive measure itself costs money. b) The preventive measure may not be effective. c) Many “preventive healthcare services” consist of some kind of screening test for “early detection,” and these screening tests almost always produce more false positive results than true positive results – leading to the need for more definitive, more expensive, and often invasive confirmatory tests. d) “Early detection” of any medical condition often detects “occult” disease, that may or may not have become manifest if it had remained undetected. e) Treating the diagnosed – and often occult – medical condition is often very expensive, produces complications, and/or is ineffective. f) Successfully preventing the target medical condition may give patients more time to consume healthcare resources for all their other medical conditions.

Please note that DrRich is not arguing here that preventive services are useless or undesirable. Often they are quite useful and very desirable. Rather, he is arguing that the healthcare system will spend more money by offering these preventive services than if it did not offer them.

This fact ought to prove embarrassing to our leaders, who have spent the last few years assuring us otherwise. Indeed, they have doggedly insisted, not only are preventive healthcare services cost-effective, but also it is precisely because of such preventive services (delivered in the remarkably efficient manner which will be achieved by our new healthcare system) that we will enjoy tremendous cost savings over the next decades.

Like Nancy Pelosi says, it’s all about “prevention, prevention, prevention.”

And having taken this bold and very public stance on prevention, our leaders are going to have to walk very gingerly (now that they have finally been successful in giving us the gift of healthcare reform), as they seek ways of cutting back on those selfsame preventive services.

They know this, of course, and have taken steps to provide themselves with the tools they will need to accomplish this feat. Their chief tool, based on what DrRich can find in the new healthcare law, is our old friend, the United States Preventive Services Task Force (USPSTF).

Readers may remember that it was the USPSTF that released the controversial new “recommendations” on breast cancer screening last fall. Readers will also recall that the USPSTF’s new recommendation, that women under 50 no longer need screening mammograms, proved quite shocking to many women – women who had been urged for over a decade by various cancer societies, by the government, and by their doctors to get regular mammograms beginning at age 40, because the early detection of breast cancer was the best way not to die from breast cancer. Indeed (readers will again recall), the outcry was so great that Secretary Sebelius quickly issued a statement reminding us that the recommendations of the USPSTF were merely that – non-binding recommendations – and that women should continue getting their screening mammograms as they and their doctors thought best.

DrRich wondered at that time whether Secretary Sebelius (who was simultaneously urging all of us to support the healthcare reform bills which were then making their way through the House and Senate) actually knew that both of those bills contained language making the recommendations of the USPSTF legally (and retrospectively) binding.

In any case, DrRich wishes to take this opportunity to remind his readers that the healthcare reform which is now the law of the land indeed makes the USPSTF the arbiter of which preventive services are to be covered by private insurers (Section 2713), by Medicare (Section 4105), and by Medicaid (Section 4106). To be sure, presumably to bail out Ms. Sebelius, new language was added (Section 2713) to say that the recent recommendations on mammography do not apply, at least not for private insurance plans. (Similar language, however, does not appear in the Medicare or Medicaid sections [4105 and 4106], so patients covered by these programs may indeed be subject to the new mammography recommendations .) New mammography recommendations aside, for the rest of the preventive healthcare services that exist in the universe, only those that have achieved a grade of A or B by the USPSTF will be covered.

Now 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 ways to withhold expensive preventive services – DrRich would like to very briefly restate his objections to the USPSTF’s recent mammography rulings.

In a word, DrRich’s problem with the USPSTF’s revised mammogram recommendations has nothing whatever to do with whether mammography is really useful or not, but rather, with the methodologies the panel used to make those recommendations. For, if those methodologies are deemed legitimate, unfortunate precedents will have been set. Specifically, by analyzing the USPSTF’s own justifications for making its new mammogram recommendations, it is possible to derive at least four new “rules” under which the panel can operate in the future.

1) The USPSTF now recommends that breast cancer screening no longer be done for women under age 50. But by the panel’s own words, screening mammography in women in the 40 – 49 age group appears as effective at reducing mortality as it is in women 50 and older, and the panel indicates this fact several times within its own document. And as nearly as DrRich can tell, the panel’s only concrete rationale for dropping mammography for women under 50 is that it has found “a new systematic review, which incorporates a new randomized, controlled trial that estimates the ‘number needed to invite for screening to extend one woman’s life’ as 1904 for women aged 40 to 49 years and 1339 for women aged 50 to 59 years.”

This rationale implies the following rule, Rule 1: If you have a preventive measure which is equally effective across a large population of patients, you can withhold that preventive measure from any arbitrary subgroup within that large population, as long as performing the effective measure in that arbitrary subgroup is more costly than it is for some other arbitrary subgroup.

2) In its public justification for withholding mammogram screening for women aged 40 – 49, the USPSTF did not emphasize cost savings, but rather, emphasized the fact that screening in this age group results in more false positive tests than for older age groups, and thus in more unnecessary biopsies, and the potential for more unnecessary emotional trauma. While this is true, the traditional response to such a circumstance would be for doctors to carefully review the pros and cons of screening with each woman, so as to allow the individual to decide whether the possibility of needing an unnecessary biopsy outweighs the possibility of diagnosing breast cancer while it is still curable.

But instead, the panel established Rule 2: Rather than allowing individuals to apply their own values when weighing healthcare decisions which reasonable people could decide either way, it is legitimate for the panel to make those decisions from on high for all patients; and furthermore, it is legitimate for the panel to make different decisions for different and arbitrary subgroups of patients (e.g., one decision for women 40 – 49 years of age, another decision for women over 50).

3) The USPSTF now recommends that women not be taught breast self examination (BSE). In point of fact, since most doctors stopped teaching BSE a long time ago, this recommendation will probably have little actual impact. But the panel came to this recommendation based on clinical trials conducted in backward, 3rd world healthcare systems (Russia and China), where outcomes with breast cancer have little to do with outcomes in the U.S.

Perhaps more to the point, a similar tactic was used in deciding to withhold mammogram screening for women under 50. That is, the “new randomized controlled trial” the panel invoked to justify this decision was conducted in England, where outcomes for the treatment of breast cancer are substantially – and famously – worse than they are in the U.S.

So Rule 3 is established: It is legitimate to take the results of clinical outcomes trials conducted in backward countries with poor healthcare systems, or in less backward countries which nonetheless have demonstrably inferior outcomes, and directly apply those results to coverage decisions affecting American patients who are being treated in the American healthcare system. This is like performing a careful statistical analysis of outcomes from a Pee Wee football league, then telling the New England Patriots to abandon the forward pass, because the percentages just aren’t there.

4) The USPSTF now recommends that women 75 and older not get breast cancer screening, despite the fact that (from the panel’s own words) breast cancer is the leading cause of death in this age group. The panel justifies this recommendation by noting that there are insufficient data from randomized trials in these patients, and further, that “women of this age are at much greater risk for dying of other conditions that would not be affected by breast cancer screening.”

It is, perhaps, convenient that very few randomized clinical trials assessing preventive measures have ever been conducted in elderly populations, and further, that if such trials were conducted, any actual benefit that might accrue to the subset of relatively healthy older people would be diluted by the inclusion of large numbers of less healthy elderly patients. And, while doctors usually have little problem identifying those healthy 75-year-olds who are likely to survive another 10 – 15 years, and in whom detecting early breast cancer would likely be beneficial, the large, long-term, randomized clinical trials “proving” to the satisfaction of the USPSTF that these women deserve screening will, for all practical purposes, never be done.

So, Rule #4: Preventive measures should not be offered to old people, because they’re probably going to die soon anyway.

Those who want to criticize DrRich  because they feel the USPSTF’s actual recommendations on breast cancer screening are appropriate may, of course, do so. But you will be revealing yourself as a dunderhead. For, as DrRich has just made quite plain, he is not necessarily criticizing the substance of the new recommendations, but rather, the dangerous methodologies the panel used to reach those recommendations, and the four new rules those methodologies have established. These precedents are very troublesome indeed – especially now that we’re no longer dealing with the quaint USPSTF of old. The new USPSTF has acquired broad new powers, and is no longer making mere “recommendations,” but rather, definitive coverage decisions which will directly affect all of us.

And this, it appears, will be the primary means by which our leaders will get out of providing us with all those robust preventive healthcare services they always insisted they were dying to implement.