Podcast:

Republicans Blithely Enter The Individual Mandate Trap [ 13:52 ] Play Now | Play in Popup | Download (84)

Progressive Americans have this much going for them: they can, without any reservations, second thoughts (or perhaps even first thoughts), enthusiastically and wholeheartedly support Obamacare’s individual mandate. For them, the individual mandate is an unalloyed good. Not only does it enable Obamacare to proceed, thus giving the government unprecedented control over every aspect of American healthcare, but it also establishes the authority of the government to control the economic activity of individuals. This new authority will come in very handy as our leaders continue working toward redistributive justice. So if you’re a Progressive, what’s not to like about the individual mandate?

Conservative Americans do not have it so easy. In principle, of course, the very idea of an individual mandate is constitutional heresy to a conservative, since it violates not only the letter but the very spirit of the Constitution. This is why, over the past three years, opposing the individual mandate has become for conservatives a more fundamental litmus test than opposing abortion. Accordingly, it is conservatives who have launched the constitutional challenge to the individual mandate, and who have now succeeded in bringing it before the Supreme Court, and who have based their chief strategy for bringing down Obamacare on the idea that the Supremes will agree with them about it.

DrRich, like most conservatives, is aghast at the idea that the Court might actually find the individual mandate to be compatible with the Constitution. Such an expansion of the power of the Central Authority over the lives of individuals will essentially gut the main idea behind our founding, and send us even more rapidly down the path toward tyranny.

But as he contemplates how he might feel on the day the Supreme Court finally strikes down the individual mandate, DrRich can’t help conjuring up the last scene from The Graduate. In that scene, Dustin Hoffman, who has just burst into the church and fought through a horde of wedding guests to grab his girl from the altar, and, with her in tow, has fought his way past the stunned groom and back through the angry crowd, and having at last jumped with her onto a city bus, is now sitting breathlessly, his hard-won love at his side, as the bus pulls away leaving their pursuers behind. And as that last scene fades, his look of elation at finally winning his heart’s desire gradually slackens, and transforms into a look of utter panic, a look that silently beseeches, “Now what?” Or, perhaps, “What have I done?”

DrRich thinks that’s what will happen to Republicans on the day the individual mandate is declared unconstitutional.

There is a reason, dear reader, that Mitt Romney, Newt Gingrich, and the Heritage Foundation, all of whom claim to be conservatives, at one time or another supported something very much like Obama’s individual mandate. That reason is: it is very difficult to conceive of a workable, market-based solution to our healthcare mess without one.

Any scheme for reforming healthcare that is based on private health insurance will fail if a substantial proportion of the population declines to purchase health insurance. Whether people have chosen to acquire health insurance or not, they will still get sick. And when the uninsured get sick there are only two choices.

The first choice is to refuse them care. Libertarians have no problem with this. They believe that if you want some healthcare, you should pay for it yourself. If you choose not to buy health insurance, or otherwise fail to make arrangements to pay for healthcare should it turn out that you need some (as well you might, if you engage in all the activities and abuse all the substances that libertarians say is your right), well, that’s too bad for you. Let your painful and untimely demise serve as an object lesson to everyone else, so that perhaps they will make better personal choices. Most non-libertarians, however, find this option abhorrent.

The second choice is to take care of the uninsured anyway. If you do that, not only do you drive up the cost of health insurance for people who have chosen to buy it, but you also create a huge incentive for people to not buy it in the first place.

This is why Republicans or conservatives who have thought deeply about healthcare reform (Gingrich, the Heritage Foundation), or who have actually instituted healthcare reform (Romney), will often settle upon a solution that incorporates something very much like President Obama’s individual mandate. Unless everyone is strongly “incented” to buy health insurance, a market-based healthcare system will collapse.

More to the point, Republicans ought to recognize that, while it seems to have wound up that way, the individual mandate in Obamacare did not start out as a sneaky way to undermine the Constitution. It was, in fact, a necessary concession to the more conservative of the Democratic members of Congress. President Obama and his minions (or handlers, depending on which talk show hosts you listen to) are on record as saying that their real goal is a single-payer, government-controlled healthcare system. And there is no reason in a single-payer, government-controlled healthcare system to invoke anything like an individual mandate to purchase insurance. The President would have been quite happy without any individual mandate, if he could have gotten his way in the first place.

The individual mandate was inserted into Obamacare purely as a necessary component of healthcare reforms that are ostensibly based on private health insurance, which is the only kind of reform the President could possibly get through even a Democratic Congress in 2010.

If the Supreme Court declares the individual mandate to be constitutional (which will violate everything DrRich holds dear about America), then it’s a huge win for Obamacare.

But if they declare it unconstitutional, that will trigger the Republican’s real problems.

Republicans, Democrats and federal judges all seem to agree that without the individual mandate, Obamacare is infeasible. The moment the mandate is declared unconstitutional, Obamacare disappears.

And this will create a “Graduate” moment. There the Republicans will be, sitting on the bus with the healthcare system they have just saved from the handsome-but-arrogant groom who had Big Plans for it, and heading to – where?  They can’t just go back to the old healthcare system; we’re past that. The health insurance industry has made it plain that their business model is broken, which is why they acceded to and even campaigned for Obamacare (a system under which they are to become federally-regulated public utilities) in the first place. Should Republicans institute their own market-based healthcare reforms? Good idea! But what do they do about the people who choose not to buy private insurance, now that they have had mandates to purchase declared unconstitutional? And even if they have an answer to that question (which they do not), do they have a plan ready to go, one that can be implemented quickly, before the healthcare system implodes? (Remember, Republicans, you will be dealing with a health insurance industry that has run out its string, and that will be at least angry if not panicked at the demise of its public-utility end-game.)

As it happens, DrRich himself has proposed a fix for the healthcare system that addresses all these problems – a system that is based on individual choice and incorporates private insurance, and at the same time covers everyone without any individual mandate, and controls healthcare costs to boot. The details are entirely irrelevant at the moment, and DrRich will not bore his readers with them now. (If you’re interested you can buy a copy of his book in Kindle format for five bucks, or if that’s too steep you can read an outline of his plan here for free.) The point is that workable solutions to our healthcare problems are indeed imaginable. The likes of DrRich has imagined such a thing, and so have others. But Republican candidates for President, and Republican congressional leaders, are not creating these solutions. Instead, they are steering us into a blind alley.

Here is what DrRich fears. When the individual mandate is declared unconstitutional next June, the Republican celebration will last all of 7.5 minutes. The insurance industry will make it very clear very quickly that they simply will no longer be able to function, and to have any hope of survival they will have to resume cherrypicking healthy patients, massively increasing premiums, denying recommended care, and dropping subscribers when they get sick. Even with these drastic steps, they will say, there’s no guarantee that health insurance will still be available for most Americans in a year or two. And at the time these astounding revelations are made, the Republicans won’t even be finished choosing a nominee, let alone be able to articulate a coherent plan for replacing Obamacare. By Independence Day panic will reign across the land.

The President will then make a speech. He will say, “We tried, America. In the spirit of bipartisanship we tried to give Republicans a system of market-based healthcare reforms, just like they say they wanted. But that kind of system requires an individual mandate, and our misguided friends on the right have now shot the individual mandate through the head. And when the American people ask those same Republicans who brought this disaster upon us, “Now what?” the American people get no answer. The Republicans are quite good at destroying healthcare solutions, but are hopeless when it comes to creating them. And you can hear for yourselves what the health insurers are now threatening to do to all of us when we get sick. It will be just like it was before, but much, much worse.

“We tried, America. We tried to create a market-based healthcare system that would be fair to all. But the Republicans, caring for nothing but their own selfish political fortunes, have blocked our efforts, and have left us all for dead.

“Fortunately, in a few short months you will be able to exercise your God-given right as Americans to choose. If you want to, you can vote into office the Republicans, the people who have traded your healthcare security and that of your family in favor of the chaos we are all witnessing today. Or you can re-elect me, and you can give me a Congress I can work with, and let us try to salvage something good from the ruins of the glorious reforms we fought so hard for the last time. Let us try to give you the best healthcare system that is still possible, given the new constraints the Republicans have now made for us. While you and I might not have started out wanting a healthcare system run entirely by the government, today our choice is either that, or the chaos, pain, suffering, disability and death that, thanks to the good offices of the Republicans and their friends in the health insurance industry, are now staring us in the face. But this is not the first time Americans have stared evil in the face. We have done it before, and we have always prevailed.

“We tried, America. We tried – but the Republicans denied, and babies died.

“My fellow Americans, in November you will have the opportunity to say no to the forces of evil, and to set this travesty right. I know the heart of Americans, and I know that you will do the right thing, not only for your own sake, but for the sake of your children, and your grandchildren, and generations of Americans yet unborn.*”

And when President Obama is finished laying out his argument, the Republican nominee, whoever he or she turns out to be, won’t know whether to cry, “Oops!” or “Nein, nein, nein!”

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*DrRich is a conservative but also a capitalist, and so his speechwriting services are available to the highest bidder. Mr. Obama, mutual “friends” in the DOJ have proven adept at tracking DrRich down when necessary, and will know how to contact him.

Podcast:

What's Really Causing The Drug Shortages [ 15:02 ] Play Now | Play in Popup | Download (99)

Last week, President Obama took unilateral Presidential action to fix the drug shortages that have been plaguing American hospitals since 2005.

He has been taking unilateral Presidential action quite a lot lately, in his effort to publicly emphasize the recent unwillingness of Congress to do his bidding, and to illustrate to us in the great unwashed how much better things would be if only the President could just go ahead and do all the stuff that needs to be done, without having to take the legislature into account.

For problems like this (i.e., drug shortages, lack of jobs, loss of “spirit,” &c.) are the price we pay when we insist on holding our leaders to the constraints imposed by some old, dusty, outdated document, written by someone else’s ancestors. (For how many of us, really, descend from either the Roundheads or the Cavaliers who wrote the thing?)

There are other ways one might run an enterprise, you know, that Adams or Jefferson probably never thought of.

In any case it is somewhat surprising that this time the President failed to take full advantage of the occasion. Namely, he did not blame George Bush for the drug shortages. He missed a real opportunity there, because had he done so he would have been more correct than usual.

Shortages of certain critical drugs have become a serious problem over the past six years or so. Generally speaking the drug shortages have involved sterile, injectable generic drugs. Sterile injectables are relatively expensive to make, and because the requirement for sterility dictates they must have a finite (and relatively short) shelf life, they are relatively expensive to manage logistically after they are made.

The shortages are in some of the more important and critical drugs used in medicine, including “crash cart” cardiovascular drugs, antibiotics, and important chemotherapy agents used for cancer. In recent years increasing numbers of patients with life-threatening illnesses have not been able to receive the drugs they need to optimize their odds of survival, and they have had to receive some substitute therapy, that is, instead of getting the drug they ought to have, they get a drug that is available. When your life is in the balance this is not a pleasant thing.

The FDA keeps an on-line list of current drug shortages, which can be found here. The list is impressively long.

Many experts (the usual suspects) have looked into the problem of drug shortages, and have come up with many explanations for it. Typically, after analysis, the reason for the shortages is said to be “multifactorial,” and includes: insufficient production space, disruptions in the supply of raw materials, several drug makers opting out of the generic drug business, and a spate of manufacturing quality issues that have resulted in prolonged production interruptions. The term “drug company greed” often hovers just beneath the surface of such explanations, and sometimes actually breaches.

Here is the formal position the FDA has taken to explain the growing drug shortages. Readers will note that it invokes all of the above multifactorials.  (And since none of these manifold causes are under the direct control of the FDA, the agency concludes, clearly it is not to blame.)

This sort of scattershot explanation for the drug shortages seems unsatisfying. It seems unfocused and random. We are to believe that a series of disparate, unfortunate events suddenly began happening to the drug industry six years ago (since prior to that there was no particular problem with these drugs), with no underlying explanation, and that all these unwanted happenstances, quite miraculously, mainly affected only one kind of product – sterile, injectable generic medications. Go Figure.

Must be one of those Black Swan deals.

Undeterred by the lack of a unifying theory to explain the problem, the President has now taken action.

He decreed the following steps.  He told the FDA to ask drug companies for earlier notice when there will be a new shortage. He asked the FDA, after the agency has ordered a halt in production of a drug due to quality issues, to speed up its reviews when the drug company says it is ready to get back on line.  And he asked the DOJ to crack down on “grey markets” that have now appeared to provide these critical drugs to hospitals for exorbitant prices.

See what kind of quick action we would get if we would just suspend the Constitution?

The problem is that the things the President is doing won’t help much, and the things that would help a lot the President is not doing.

It should not be this difficult to figure out why we are having drug shortages. Yes, DrRich agrees that the proximate reasons are multifactorial. But the proximate reasons for product shortages are always multifactorial, because when the root cause of a shortage is itself beyond their control, the product-makers will always try multiple, marginally effective and often counterproductive ways to mitigate the root cause, thus creating a multitude of potential proximate causes for problems. And if an analyst does not look beyond those proximate causes he might not see the root. This often happens when seeing the root would be inconvenient or embarrassing.

The root cause of any persistent product shortage is almost always the same. For one reason or another, the cost of providing the product has outstripped the price the product-maker can get for selling the finished product.

In a free market, when the cost of production goes up the price of the finished product rises accordingly. As long as the customers can pay the higher price there will be no shortage of the product. If the price rises so high that customers won’t pay it, the demand for the product drops – and production is adjusted to reduce the supply in accordance with that reduced demand. But even in this case, there is no product shortage, because even if more product were available nobody would buy it.

Sometimes a sudden increase in demand for a product will create a product shortage. But the higher prices enabled by this new demand will entice the product-makers (greedy bastards!) to increase their manufacturing capacities, and will attract new product-makers to go into business, and eventually the shortage will be resolved. In free markets, shortages are usually temporary and self-adjusting.

In general, truly persistent shortages will only occur when the product-makers cannot increase the price they get for their finished product sufficiently to keep up with a rising cost of production. In this case profit margins shrink or even become negative, and the incentive to expand production, or even to stay in that business, disappears. This is a true shortage – the demand is still there, and customers are willing and able to pay the price being asked, but the product-makers are no longer able to supply the product at that price. Unless the mismatch between the cost of production and the price of the finished product is repaired, the product shortage becomes persistent or even permanent.

Such a persistent cost/price mismatch does not occur in a free market. It occurs when some Central Authority acts to control prices (often, to be sure, while simultaneously acting to increase the cost of production). A Central Authority can cap effective price a product-maker can get for his/her product by implementing overt or hidden price controls; by increasing marginal tax rates high enough to push the product-maker’s risk/reward calculation to favor inaction; and by instituting windfall profit taxes that do the same thing. DrRich is certain that Progressives have thought up a number of other ways to bolix-up the supply/demand relationship as well.

We do not need to know anything in particular about manufacturing generic, sterile injectable drugs to know that it is very likely that the persistent shortages we are seeing in these products are probably due to a persistent, externally-imposed mismatch between the cost of production, and the prices the companies can get for selling these drugs. And whatever caused that mismatch must have occurred before 2005.

And lo and behold! We find that a recent Medicare law (Section 303(c) of the Medicare Modernization Act of 2003) strictly limits the price Medicare will pay for “injectable” generic drugs. Prices for these drugs can still rise, but only by 6% or less, and only once every six months.  Congress (in its great wisdom and expertise in matters economic) made the judgment that this kind of price rise would be sufficient to balance market forces. But Congress was wrong.

This law took effect January 1, 2005.

The margins companies get for generic drugs are already low. And the cost of making (and managing the distribution of) sterile, injectable drugs is inherently higher than for most generic drugs. So the profit margins for these drugs, already low, was severely challenged by these new price controls.

The industry reacted quite rationally and predictably to this new law.  The big companies, which could maximize their profits by devoting their manufacturing space to other products, got out. And new, generic drug companies got in. These generic drug companies do not have to bear the cost of research and development, so their overall cost of production is substantially lower than for the big companies – their business models indicated they could pull a reasonable profit even with the price controls, if all went well. But to do so, they had to employ cheaper manufacturing processes, with less quality control and less production redundancy. So, quite predictably, there were quality issues, and when these issues occurred there was no redundant production capacity available to pick up the slack. And stringent new FDA standards meant that each time such an issue occurred, their production would be off-line for months, or even a year or longer.

But for DrRich to belabor the story from this point would only be to elaborate on the multitude of proximate causes for the drug shortages, all of which are merely artifacts of the ways the industry chose to respond to the root cause – i.e., to government-imposed price controls.

The President’s executive order ostensibly aimed at fixing the drug shortages will of course be ineffectual. While it implies new regulatory zeal which will further increase the cost of production and worsen the cost/price mismatch, it does not acknowledge let alone address the root cause.

In this light, the President’s attitude toward the grey market that has sprung up in response to the drug shortages is particularly instructive.  A grey market, as DrRich understands it, is like a black market but less illegal.  And we know a lot about black markets.

A black market acts outside the legal economy to provide customers with products they cannot get within the legal economy. The price a black market dealer gets for the product simply reflects current market forces, given the product shortages which exist within the legal economy, the risk the black marketeer takes in providing the product extra-legally, the additional “security” they require, &c.  So the customer pays through the nose, but at least he can get the product he wants or needs.

The very presence of grey/black markets generally indicates that the shortages which are present within the legal economy are not inherent but artificial – that is, the products are demonstrably available, for the right price. That product’s abundance would increase and the price would adjust to some more reasonable value if only the customer were permitted to pay what the market will bear. (The true free-market price for any black market product will always be far higher than the legal economy allows, but far lower than the black market demands.)

Fulminating about the greed of the grey marketeers does not hide this truth.

No wonder the President’s new decree attempts to convert the grey market for sterile injectables into a true black market, and in this way aims to snuff out this extremely embarrassing, all-too revealing, spectacle.

Podcast:

Regarding Those Conflicts of Interest On The Government Guideline Panels [ 13:08 ] Play Now | Play in Popup | Download (92)

DrRich does not like to pick on the New York Times.

No, really. DrRich does not like to pick on the New York Times, because he receives two paychecks each month from the New York Times*. This fact (which has been disclosed on this blog since its inception in 2007) constitutes a clear conflict of interest, at least when it comes to writing blog posts which might criticize or satirize or mock articles that appear in that venerable publication, from which he receives a not insubstantial proportion of his livelihood.

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*DrRich holds two positions at About.com, which is a New York Times Company. He has manged About.com’s Heart Health Center for 11 years, and also serves on About.com’s Medical Review Board.
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Yet, regular readers will know that the New York Times has served as a regular source of material for DrRich here at the CRB, and little of what he has written in response to that material has been supportive of it. Indeed, the opposite is true.

DrRich considers it his duty to respond to the New York Times whenever it publishes an article that advances the covert rationing of American healthcare, which (through no fault of his), it does frequently. The New York Times serves as a chief voice of Progressive America, and the Progressive takeover of the healthcare system has become, since this blog was first begun, the chief driver of covert rationing. So, conflicts of interest to the contrary notwithstanding, DrRich submits to his readers that he has acted responsibly and honorably despite his unfortunate financial conflicts.

But still, he does not like to pick on the New York Times.

It is unfortunate for DrRich, then, that for the second time this week he is compelled to do so. And this time, as it happens, the subject matter has to do with conflicts of interest (a subject about which, as he has just disclosed once again, DrRich knows something).

Today, the Times writes that experts are beginning to worry that the GOD Panels (Government Operatives Deliberating) now working to devise the clinical guidelines under which American doctors will be strictly compelled, under penalty of the law, to decide which patients will get what, when and how, are tainted by members who have had ties to (gasp!) industry.

When the GOD Panels were first set up, not very long ago, it was still considered acceptable for some members to have industry ties as long as they fully disclosed those ties, and recused themselves from voting on matters specifically related to their industry work. Having at least some members with industry ties was deemed essentially unavoidable, because it was thought that deep subject-matter expertise would be desirable on these panels. Since most clinical research in America is paid for by industry, it is difficult to have deep expertise without having had at least some contact with industry.

But as the Times indicates, modern medical ethics has now advanced well past this kind of primitive thinking. Nobody with any industry ties has any business being on a panel with such overwhelming authority over the practice of American medicine.

David J. Rothman, president of the Institute on Medicine as a Profession, tells the Times, “Consciously or not, they may well be making decisions that fit their funders, their payers and not the patient’s best interests. If you want the public to really believe in the guidelines, why not have a committee that is conflict-free?”

And the ubiquitous Dr. Steven Nissen of the Cleveland Clinic (a person DrRich numbers among those individuals who, by their public words and deeds, he speculates may be auditioning for the really important GOD Panels) says, “Recusing, disclosing — the reason it doesn’t work is the process involves give-and-take. Even if you don’t make a formal vote, you can still have a huge influence over what happens in the process.”

And so, while the Times does not come out and say so, it seems as if a purge of the GOD panelists may be already afoot. If not an actual purge, then at least the “conflicted” panel members are being sent a clear message, well before they take any final action. And at the very least, Ms. Sebelius is being given the cover she needs to select the people she really wants for the truly important GOD Panels which are being constructed for Obamacare.

All of this is pretty clear, and DrRich has great confidence that his readers can figure it out for themselves.

What DrRich really hopes to accomplish here is to note for posterity the great paradigm shift that has occurred in just the last two or three years, regarding the appropriate relationship between physicians and industry.

Until very recently, the American public, doctors, industry, and medical ethicists thought about that relationship in a certain way, which DrRich will call Theory A:

Theory A:

-  Medical progress is Good, and benefits mankind.
-  Industry is responsible for a high proportion of medical progress.
-  Industry-driven progress requires the active participation of physicians.
-  Therefore, a well-managed cooperation between industry and physicians is beneficial to mankind, and ought to be encouraged.

If you subscribe to Theory A you believe that, because well-managed physician-industry relationships benefit mankind, these relationships are good. So, fundamentally, it’s the management of these relationships which is at issue. These beneficial relationships produce unavoidable conflicts of interest, which we must manage by strictly limiting their extent, and fully disclosing the ones that are left.

So traditionally, the debate about conflicts of interest have been about where to draw the necessary limits.

What today’s New York Times article points out is that Theory A is no longer operative. The new thinking begins with the proposition that no amount of conflict of interest is acceptable, and ALL physician-industry ties should be prohibited. One of the most prominent advocates of this new thinking is Jerome Kassirer, former editor of the New England Journal of Medicine, who says, “The ideal handling of conflicts of interest is not to have them at all.” For these voices, Theory A simply does not apply. Rather, they subscribe to Theory B:

Theory B:

-    The greed of medical industry creates excessive costs, and produces far more harm to society than good.
-    Physician-industry alliances strengthen industry, and increase the harm.
-    Therefore, crippling these unholy alliances is critical to the interests of society.

Underlying Theory B, of course, is the largely unspoken and unacknowledged, but nonetheless fully-embraced, proposition that medical progress is not Good after all, but is the very thing that is driving up our healthcare costs, and so it must be stifled.

A corollary of Theory B is that not only is the Central Authority the only entity which is strong enough to cripple these unholy alliances between physicians and industry, but it is the duty of the Central Authority to do so.

Proponents of Theory B, noting, not incorrectly, that medical industry is chiefly concerned with profits rather than the public good, conclude (in a manner compatible with Progressive if not classical logic) that therefore industry will always behave in ways that are counter to the interests of society.  While many proponents of Theory B will agree that industry provides at least some benefits, they are convinced that these benefits are far outweighed by the harm they produce to the collective. Therefore, Theory B proposes to stifle, if not cripple, medical industry. And a very useful strategy for achieving this goal is to de-legitimize any practical relationships whatsoever between medical industry and physicians.

Proponents of Theory B rarely say what their real goal is. To come out and say that their goal is to cripple the companies responsible for producing medical progress would not be expedient. So most of them still give lip service to Theory A. One must discern their real motives from their behavior.

Much of that behavior, in practical terms, has to do with controlling the flow of information. Let industry develop whatever it wants (perhaps), but don’t let profit-drunk industry – or its greedy physician spokespersons – instruct doctors and patients on who ought to use industry’s products, or when and how. That kind of information can only be managed by unbiased sources.

This is the very thinking that produces the impetus for GOD Panels in the first place. Only experts who are free of industry ties and who answer only to our beneficent, unbiased, completely objective government can say which products of industry are good and bad, and can manage the flow of information about them. Information coming from anywhere else is to be regarded as being charged with bias and greed, and should be ignored, or even suppressed by whatever means are necessary.

To any reader who believes that our government is or can ever be an unbiased and honest broker, or that government officials (or GOD panelists) can cancel their own human natures when they put on a government name tag, DrRich can only wish upon you the grace of God (the old fashioned one). You’ll be needing it. To the rest of us, it is obvious that the government is desperately biased when it comes to medical progress in general, and in particular when it comes to establishing “guidelines” for the use of expensive drugs and medical devices.

For Theory B to have become the operative paradigm in America, as the New York Times today suggests it has, will assure the Central Authority that it is free to seed its GOD Panels only with members whose bias runs in their direction.

But under Theory B there is no government bias. There is only industry bias. And when we purge the GOD Panels of all industry bias, by definition we will have created perfect objectivity.

And this is why DrRich feels so comfortable continuing to write this blog despite his obvious financial conflict of interest in favor of the Times. For a conflict of interest in the direction of the Progressive agenda is no conflict at all.

Podcast:

Medical Screening Tests - A Bad Idea? [ 10:59 ] Play Now | Play in Popup | Download (102)

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.

Podcast:

Some Implications Of the New PSA Recommendation [ 16:21 ] Play Now | Play in Popup | Download (98)

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.

Podcast:

About Those Doctor-Nurses [ 17:19 ] Play Now | Play in Popup | Download (239)

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.

Podcast:

A Regulatory Speed Trap Waiting To Be Sprung [ 17:13 ] Play Now | Play in Popup | Download (225)

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.

Podcast:

Why Governor Christie Must Not Run [ 12:03 ] Play Now | Play in Popup | Download (156)

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.

Podcast:

In The Million Hearts Initiative, Cardiologists Need Not Apply [ 13:18 ] Play Now | Play in Popup | Download (247)

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.

Podcast:

Gibson Guitar and the Regulatory Speed Trap [ 10:50 ] Play Now | Play in Popup | Download (346)

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.