Podcast:

More On The Potential Dangers Of Salt Restriction [ 7:55 ] Play Now | Play in Popup | Download (81)

This past summer, DrRich wrote a post on the utter arrogance of the public health experts who are urging the FDA – and international bodies of busybodies – to mandate a policy of strict sodium restriction across the globe.

DrRich attempted to show how such a broad-based salt restriction at this juncture is ill-advised for three reasons. First, the conclusion that a population-wide salt restriction would actually do any good is not based on any actual prospective studies, but on a contrived extrapolation of observational data. Second, there is some evidence that a salt restriction would be harmful to at least a substantial minority of people, even if the overall effect on the population turns out to be positive. And third, there is good reason to believe that the degree of sodium restriction which is being recommended by the public health experts is below the level which is dictated by human physiology.

Perhaps salt restriction for the entire population will turn out to be a good idea. But perhaps not. So in his previous post, DrRich was advocating a prospective, randomized controlled trial to test this proposition before just going ahead and inflicting it upon hundreds of millions of Americans.

And now, as it happens, in recent weeks new studies have been published which question the safety of salt restriction for the whole population. In fact, five studies have been published just this year suggesting that salt restriction might be unsafe.

The latest, published this week in the Journal of the American Medical Association,  suggests that when you compare cardiovascular events (such as heart attack and stroke) to sodium intake, the incidence of those events follows a “J” curve. That is, cardiovascular events are lowest at an “optimal” level of sodium intake. But if sodium intake goes above that optimal level – or if it goes below it – the incidence of cardiovascular events increases.

According to this study, the “optimal” level of daily sodium intake is 4000 – 5999 mg of sodium per day. Cardiac outcomes worsen for those with sodium intakes above or below those values.

And, of course, the public health experts are recommending sodium intakes far below the 4000 mg threshold. They recommend (and urge world governments to enforce) sodium restrictions of 1500 mg per day for the people they consider to be at high risk (which amounts to about half of us), and restrictions of 2300 mg per day for the rest of us.

This kind of restriction would place everyone on an unenviable portion of the J curve, according to this new study, and would risk exposing all of us to an excess of cardiovascular disease.

The public health experts, of course, will not take this slander lying down, and accordingly have been quick to respond. Interestingly, their response sounds a lot like the response of the global warming experts whenever someone has the audacity to introduce new evidence that questions some of their conclusions.

Heartwire quotes Dr Graham MacGregor of London’s Wolfson Institute of Preventive Medicine (and a major sodium restriction guru) as saying, “[These new studies] are a minor irritation that causes us a bit of aggravation, and we have to talk to journalists about it, because they are not interested in news saying salt is dangerous.” MacGregor insists that the need for global sodium restriction (like global warming) is a settled issue.  “What [these irritating investigators] fail to understand is that the FDA is not asking for evidence about why salt should be reduced, they are asking how it should be reduced.” So apparently, new data need not apply.  It is neither being sought, nor will it be accepted.

Other experts have pointed out that these new studies urging caution on restricting salt were not the kind of prospective, randomized controlled trials that are so valued in medicine, so their results should not be taken too seriously.

DrRich might be more inclined to agree with this admonition if the studies that suggest we ought to employ severe, widespread salt restrictions were randomized, controlled trials. But they, also, are not.

What we have is two sets of very confusing observational data that can be interpreted to say different things. It may be true that a severe population-wide salt restriction would be a huge boon to mankind. But it may also be true that it would harm more people than it would help – or that it would harm and help about the same number, so the overall results would be the same.

The fact is, we just don’t know.

We have already seen the harm that can be done when we allow public health experts to launch major population-wide dietary changes, without adequately studying what their effects will be. Especially given the increasing evidence of the harms that might be done by it, we are nuts if we allow the arrogant expert class to enforce a salt restriction program on all of us, before we adequately study its likely results.

Of course, the whole thrust of our new healthcare system is to allow the experts to practice medicine on the whole population.  So urging caution or even a certain amount of circumspection on this newly-empowered expert class is destined to be a futile exercise.

Podcast:

The Occupy Movement, The Tea Party, and Healthcare [ 11:24 ] Play Now | Play in Popup | Download (74)

Some of DrRich’s conservative friends become quite exercised when they hear news commentators in the major media favorably contrasting the Occupy Wall Street movement with the Tea Party.

The Tea Party, the news readers intone, is a phony “movement” dreamed up by the Koch brothers to embarrass our first black president and to consolidate their own wealth, for which they recruited hordes of superstitious, back-woods, gun-toting, ignorant, NASCAR-loving, Bible-thumping, bigoted Ma and Pa Kettles to gather on the Mall, along with their Fox News cheerleaders and their country music stars, in a futile attempt to intimidate the enlightened leaders of the Democratic party into abandoning their program of good works. The Occupy Movement, in contrast, is a spontaneous uprising of innocent and right-thinking citizens against the tyranny of the Republican-controlled Wall Street fat-cat oligarchy, and their noble efforts have been explicitly blessed by such luminaries as Obama, Biden, and Pelosi.

Conservative Americans have a different perspective: The Tea Party was a completely spontaneous expression of public disapproval of a federal government run amok, and its gatherings are notable for its respectful, clean, polite, hard-working, law-abiding participants. The Occupy Movement, in contrast, is a contrived, Soros-funded attempt to undermine the American system, and, as one might expect from such a travesty, the Occupadoes are filthy, lawless, selfish, lazy and unappreciative of the blessings of America, which they themselves (judging from their smartphones and college degrees) have demonstrably received.

What conservatives and progressives seem to agree upon, in the matter of the Tea Party vs. the Occupy Movement, is that one is disruptive and disreputable, while the other is enlightened and constructive. They simply differ on is which is which.

For the benefit of his readers, DrRich would like to point out that, despite the foregoing, the Tea Party and Occupy Wall Street actually have a fundamental similarity between them. They are both middle class movements which are motivated by a conviction that the American system is moving in the wrong direction, that a major feature of that “wrong direction” is that an elite few have gained power that has enabled them to block the upward mobility that is supposed to be a part of the American compact, and that a fundamental change is in order. The solutions they advocate are very different from one another, of course, but their problem statements are very similar. And, most significantly, they both arise from the middle class.

At least since around 1500 AD (since the time when we can say that a middle class was present in most Western societies) the true revolutions – rapid, fundamental changes in the political system (not merely in who is leading the political system, but in the system itself) – have come to pass only when the middle class has finally become sufficiently aroused to demand (or at least tolerate) radical change. The American revolution, the French revolution, the Cromwell revolution (and the subsequent restoration), the Iranian revolution, the Nazi takeover of Germany, the fall of the USSR, various Mexican and South American revolutions, and virtually every revolutionary political upheaval one can think of in the last 500 years occurred only when the middle class had finally had it.

Political leaders instinctively understand that they can treat the poor and downtrodden as badly as they want to, and they will never rise up. (This is where John Brown got it wrong.) And so, from the political standpoint, while it might be worthwhile stirring up the emotions of the poor (at least in a democracy), in general the actual needs of the poor can be safely ignored.

But the needs of the middle class must be seen to, at all costs.

This is why Democrats (and their supporters in the media) were so unreasonably critical of the Tea party movement when it first presented itself, painting it as violent, unAmerican and racist, despite the fact that no objective evidence supported any of these charges. They were frightened nearly unto death by the implications of such a widespread middle-class expression of dissatisfaction with the direction the country is going – a direction that had been manifest for decades, but which was greatly accelerated during the first years of the Obama Presidency.

And it explains why Republicans were so quick to identify with the Tea Party (even though the mainstream Republican party is actually quite suspicious of it).

And so, when the Occupy movement finally appeared – a different middle-class movement sporting a redistributive agenda that is in line with major elements of the Democratic party – our Democrat leaders could not contain their delight. This, despite the rather odious and “non-traditional” behavior of the Occupadoes, including their public defecation, urination, fornication, rapine, drug use, property destruction, &c, that, in more normal times, would have politicians of both parties lining up to vilify them. Democrats reassure themselves that, while the Occupadoes might be dirtbags, if we play our cards right they can become OUR dirtbags.

Smart politicians in both political parties recognize the potential for real revolution in both of these movements – to reiterate, that both arise out of the middle class, and both are demanding fundamental change – and they understand the need to co-opt the one, and suppress the other.

And so the battle lines are drawn. The Tea Party agenda, which is often unfairly summarized in diminished form as “smaller government and lower taxes,” actually is fighting to restore the Great American Experiment, as articulated in the Declaration of Independence and the Constitution, whereby the autonomy of the individual is paramount. Under the GAE, the chief job of the government is to protect the citizenry from foreign aggressors, to grease the skids of a free economy, and to allow free Americans to strive as they will, and in doing so, the government may utilize only its very few, explicitly enumerated powers, and otherwise must stay out of the way.

In contrast, the agenda of the Occupy Movement is a levelling one. The fruits of America should be distributed equitably, so that there are no longer haves and have nots. Obviously, the only entity that can accomplish this feat is a strong, all-powerful Central Authority, which can confiscate the property of the “greedy” and award it to the “deserving.” Fundamentally this means that all property, in fact, is the government’s. To the Occupy supporters, while few of them will come out and say so, the Constitution is not a sacred document, but rather is an unfortunate and obsolete impediment to progress, a document that must be undermined and replaced.

To brush off either of these movements would be a mistake. Each of them is firmly grounded in the middle class; each of them discern a fundamental problem with the American system that can no longer be ignored; and each of them have already taken to the streets demanding that solutions cannot wait, and that action must be taken now.

But the two solutions being demanded by these two movements are not merely different; they are polar opposites, and are deeply irreconcilable.

Our political leaders have likewise taken sides, and the sides being irreconcilable, we can expect no cooperation or compromise between their two camps, at least not until we have another election in which the great, seething, conflicted middle class has an opportunity to say which of the two movements they have now spawned actually holds the key to their hearts.

This is a blog about the American healthcare system, and DrRich has not been bashful about expressing his belief that Obamacare – whatever good elements it may contain – is fundamentally a vehicle for undermining the autonomy of individual Americans, and handing to the government the authority to determine who in this country will get what, when and how. Until the last few months DrRich viewed the fight over Obamacare as the proxy fight for the real, underlying, fundamental question – the question of what kind of country we will be from now on.

But between the Tea Party and the Occupy Movement, DrRich has come to believe we no longer need a proxy. It looks more and more like we will have this fight out in the open, and instead of settling it with the kind of sneaky legislative legerdemain that brought us Obamacare, perhaps it will be decided by an actual election.

But whether it is decided by an election, a coup, or an exhausted capitulation, the fate of American healthcare – and everything else American – will ride on which of these two movements eventually predominates within the middle class.

Podcast:

Being Thankful for the Uninsured [ 11:33 ] Play Now | Play in Popup | Download (706)

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(In what has become a tradition over the past few years, DrRich proudly reprises his annual Thanksgiving message to his beloved readers.)

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Gathered around the Thanksgiving table, DrRich’s large extended family, carrying out a longstanding tradition, each offered in their turn one reason for being thankful on this most reflective of American holidays. DrRich listened respectfully as each of his loved ones, and each of the ones he was obligated to tolerate benignly because they had married (or in some other manner had committed to) one of his loved ones, recounted a cause for thanks. There is no need for DrRich to recite their utterances here, because they were all perfectly predictable and fairly mundane, having mostly to do with items such as maintaining good health, finding a job, being able to afford one’s mortgage payments, getting a passing grade in French, receiving a new puppy, Mr. Obama’s remarkable Presidency, the apparent continued structural integrity of the Universe despite Mr. Obama’s Presidency, &c., &c.

When it was at last DrRich’s turn, he, in retrospect perhaps somewhat inadvisedly, was unable to refrain from displaying his keen insight and superior analytical abilities on matters related to healthcare (a topic, anyone would have to admit, about which most of us would very much like to feel thankful). Lifting his glass, DrRich pronounced that he was most deeply and humbly thankful for the 47 million Americans without health insurance; and further, especially thankful that their ranks  must surely be growing, given the recession, advancing unemployment, imminent collapses of businesses and indeed entire industries, &c. And even though Obamacare promises to significantly reduce that number, DrRich went on to express his fervent wish that large numbers of the uninsured might still be with us a year and two years and even ten years hence, for the great and good benefit of us all.

Enjoying the remainder of his Thanksgiving meal out on the back porch with the new puppy, DrRich composed in his mind this explanation which you now behold for the keen appreciation he has developed for the uninsured. He now offers this explanation both to his readers, and to the few members of his extended family who, he believes, might have been inclined to hear him out, had Mrs. DrRich not offered at that moment to consider remaining married to him only if he would retire from the table immediately. (Believing his marriage to be a union sanctified in heaven, he did so.)

In any case, for those who have an open mind, there are two compelling reasons we should be thankful for the uninsured, and should be particularly loath to allow them to disappear.

The first reason is that it is largely thanks to the uninsured that we are able to maintain the fundamental and dearly-held American fiction that there need be no limits on healthcare. (The image DrRich conjures up when he says “dearly held” is that of Gollum caressing the Ring.) Simply put, when we have tens of millions of uninsured Americans who don’t have ready access to regular and routine healthcare, then it’s relatively easy to pretend that “healthcare” should include everything we might want it to include.

Our current healthcare system relies heavily on using the uninsured as a huge fiscal safety valve. That is, in lean times (such as now), we open up the valve, increasing the number of people who are ineligible to consume routine healthcare. Increasing the number of uninsured Americans has become perhaps our most effective mechanism of covert healthcare rationing.

This simple expediency alone goes a long way toward enabling us to avoid having to consider or discuss limits. Openly recognizing the unavoidable limits to healthcare, much less having to figure out how to implement such limits fairly and rationally, would be exquisitely painful and disruptive. (Just ask Gollum how unpleasant it is to be forcibly separated from that which we love and deeply value.) For helping us to avoid such pain and societal disruption, we clearly owe a great debt of thanks to our uninsured brethren.

The second reason came to light recently in an article in the Journal of the American Medical Association.* This article showed that – contrary to both popular lore and to stern pronouncements by policy experts bent on convincing us that (next to global warming) reducing the number of uninsured Americans is the most important task of mankind – the overcrowding in American emergency rooms is NOT due to the uninsured. Rather, it is due to insured Americans who cannot get in to see their primary care physicians.

DrRich has discussed at some length the primary care crisis and its causes. That is a very important topic, but it’s not the topic of this particular posting. This posting is about the great and abiding value of the uninsured.

It really should not be a great surprise that emergency room overcrowding doesn’t have all that much to do with the uninsured. While it is difficult to generalize about such things, a large proportion of the uninsured are people who have assets. (If they had no assets they likely would be eligible for Medicaid.) That is, they are people who have jobs, homes, cars, &c., but their employers (who, in many cases, are themselves) cannot afford to provide them with health insurance. The chief point being, of course, that these individuals have something to lose.

These are not the people who will voluntarily enter an emergency room for their healthcare, at least, not for a medical problem that they can somehow convince themselves might go away on its own if they give it a chance (such as, perhaps, crushing chest pain, or paralysis of the left side, or some other such eventuality which might cause some of us less circumspect, more insured people to just go ahead and dial 911, all willy-nilly). They realize that the moment they set foot into an emergency room they will generate a bill of at least several thousand dollars, which they will either have to pay, or spend months or years fighting off the increasingly aggressive bill collection professionals being dispatched these days by their local hospitals. They are putting their assets and their futures at risk if they come to the emergency room.

Rather, the overcrowding is due to people who have insurance – whether it’s Medicare, Medicaid or private insurance – and who are therefore entitled to their healthcare by whatever means they calculate is the most convenient for them. Increasingly, because primary care practices are hard to find, are booked for weeks in advance, and are less and less user-friendly by the day, the convenience calculation tends to default (incredibly) to the emergency room. (That insured people are choosing emergency rooms – notoriously one of the most unpleasant experiences American citizens can encounter in peacetime – instead of the offices of their primary care physicians should itself set off major alarms about the state of American primary care.)

This is all fairly intuitively obvious, and the JAMA article really should surprise only those who habitually believe all the prevarications being promulgated as Gospel today by politicians, media, and various authorities on healthcare.

It should be plain that suddenly providing tens of millions of Americans with health insurance will decidedly not relieve emergency room overcrowding, as the policy “experts” all promise us (the same experts, apparently, who promised us that the stimulus package would rescue the economy and prevent increased and prolonged unemployment, and who confidently spout a host of predictions which fly in the face of history, common sense, and laws of economics, physics, and human nature). On the contrary, creating tens of millions of newly insured individuals, without simultaneously revolutionizing our attitudes and policies toward primary care medicine, will quite obviously make our already overcrowded emergency rooms absolutely burst at the seams, and render even more hellish than it is today – even deeper down within “grief’s abysmal valley” – the prospect of entering such a place. Indeed, if we suddenly insure all these people, the rest of us who currently have insurance really won’t have anywhere to go to get our healthcare.

So. QED. As DrRich said at the Thanksgiving meal, thank God for the uninsured.

Clearly if DrRich had been permitted a mere five minutes to explain himself, not only might he have avoided eating runny mashed potatoes in a steady drizzle, but he also might have salvaged his reputation among some of the more remote members of his extended family, who really don’t know what a swell and reasonable guy he can be. Next year when his turn comes, DrRich will choose to be thankful for some more traditional value, in the hopes of being allowed to eat his meal in a warmer, drier, friendlier environment – perhaps he can be thankful for the growing number of obese Americans, and the great service being provided by these patriots-to-mankind as they reduce global warming.

* Newton MF, Keirns CC, Cunningham R, et al. Uninsured Adults Presenting to US Emergency Departments: Assumptions vs Data JAMA. 2008;300(16):1914-1924.

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:

Regarding Taxpayer Support of the Evil Drug Companies [ 14:14 ] Play Now | Play in Popup | Download (87)

A key goal of the Central Authority, as it contemplates how best to run our healthcare system, is to do whatever it can to stifle medical progress. Medical progress usually means introducing new drugs or new medical devices, which are often very expensive in themselves, and worse, which often threaten to improve the survival of some category of patients with chronic disease. So typically, medical progress greatly multiplies the costs of healthcare, and all the Central Authority gets in return is more chronically ill people to contend with. For this reason, suppressing medical progress is a critical aspect of covert healthcare rationing.

It goes without saying that a major tactic in achieving this goal is to demonize the drug companies. If the pharmaceutical industry can be made out to be sufficiently evil, corrupt, greedy, and callous to the needs of the people, then it will become the duty of our leaders to constrain them, and in so doing, to limit their ability to develop and introduce new products. This is easily done by adding daunting new regulations, or by piling on oppressive new taxes, or by legislating “windfall profits” penalties, or by using the threat of the regulatory speed trap to threaten them with massive fines or imprisonment. It is indeed fortunate for the Central Authority that the drug companies are, in fact, not the most fastidious members of the corporate community, and that their actions and methods often suggest many fruitful avenues for demonization.

One such avenue that is particularly fruitful, since it recruits the public squarely into the camp of the prosecutorial horde, is to show how the corrupt pharmaceutical industry feeds at the trough of the American taxpayer.

A few years ago, to specifically document this sort of reprehensible behavior, the New York Times pointed us to the case of Dr. Laszlo Bito and the anti-glaucoma drug Xalatan.

In the early 1980s Dr. Bito, a researcher at Columbia University, made a key discovery about a new class of substances that could potentially treat glaucoma. His research was funded with American tax dollars through the National Institutes of Health.

Subsequently, the pharmaceutical giant Pharmacia purchased the rights to Bito’s discovery for a mere $150,000. Based on Bito’s tax-supported work, eventually Pharmacia released the anti-glaucoma eyedrop preparation Xalatan. Xalatan rapidly became a worldwide best-seller, yielding as much as $500 million in sales per year. For their part in this unalloyed success story, Columbia University has netted over $20 million in licensing fees and royalties, and Bito himself became a millionaire.

Meanwhile American glaucoma sufferers are forced to spend upwards of $50 every six weeks for a tiny vial of the drug, which costs the company only a small fraction of that amount to produce, and whose discovery the glaucoma sufferers paid for with their own tax dollars. And, as if to guild this already brazen injustice, Pharmacia makes Xalatan available in Canada, France, and most other countries around the world (where taxpayers decidedly did not support the discovery of the drug), for less than half what American patients pay for it.

It seems, the Times points out, that the American taxpayers are the only parties in this little scheme who reap no financial return on their investment. All they got were some expensive eyedrops.

And so, drug-company demonizers would have us conclude, this is a particularly egregious example of how the evil pharmaceutical industry is ripping us off. Not only are the drug companies mercilessly profiteering from sick Americans (which indeed is their openly-admitted business model), but they are also picking the pocket of every American by using our tax dollars to invent new drugs, then selling those drugs back to us at exorbitant prices. This, one could reasonably argue, is at least as sociopathic as anything the tobacco companies ever did. (The tobacco companies, in contrast, at least had the good graces to eventually stop claiming that their products were beneficial to one’s health.)

And (we in the great unwashed are all supposed to agree), if this reprehensible behavior doesn’t give our government the right to control the prices charged by drug companies, one would be hard pressed to say what does.

DrRich certainly doesn’t want to absolve the pharmaceutical industry of all responsibility for drug prices that seem obviously too high, or for the striking disparities we see in the prices they charge for their drugs between the U.S. and other countries. He has read the complex justifications, published by apologists for the pharmaceutical industry, as to why drugs in Canada cost so much less than in the U.S., and why a tablet whose actual manufacturing cost is five cents is sold to our elderly sick for five dollars. DrRich thinks that, despite all the pretty explanations the pharmaceutical industry gives for these “seeming disparities,” drug companies simply do what every other industry does – they charge the highest price the market will bear, for each market in which they participate. If they didn’t do this, they would be abrogating their fiduciary responsibilities to their shareholders.

There is much not to like about high drug prices, or the fact that people in other countries reap the benefits of American research for far lower prices than Americans do. And it is reasonable for us to seek to address these pricing issues. But as we address certain inequities in drug pricing, we should be careful that in doing so we don’t throw the baby out with the bath water. So if we’re going to alter the arrangement we have with the pharmaceutical industry, let’s be clear on how that arrangement works, and why we set it up in the first place to operate as it now does.

Consider once again the glaucoma drug Xalatan, and consider how Dr. Bito’s discovery was actually used by Pharmacia.

Bito did not discover a finished product. Instead he discovered a new concept for reducing intraocular pressure (that is, for treating glaucoma), and demonstrated that it could be effective – but the specific compound he discovered was not marketable. In fact, it was so highly irritating when applied to the eye that it was simply not suitable for human use. (DrRich does not understand why the drug companies are the evil players in this story, when Columbia University so obviously allowed research to proceed in their facilities in which irritating substances were intentionally placed into the eyes of bunnies or other cute animals.) Indeed, Bito’s new compound was so impressively unusable that, before Pharmacia bought the rights, his discovery had been offered to and rejected by a host of other drug companies as being completely infeasible.

So when Pharmacia finally agreed to pay for the rights to Bito’s patent, they took on an expensive risk that, some estimated, had less than a 5% chance of achieving success. Pharmacia assumed the difficult task of developing a brand new synthetic molecule that would have all the benefits described by Bito, but at the same time would not have the prohibitive side effects. There was no assurance at all that such a molecule could ever be developed, and the cost of searching for one would dwarf the cost of purchasing Dr. Bito’s compound in the first place.

If such a thing turned out to be feasible, then the company then would have to conduct painstaking and extraordinarily expensive human research trials, and if successful, would then have to shepherd their new compound through a time-consuming and costly regulatory gauntlet – which explains why the vast majority of promising new drugs fail to ever gain FDA approval. That their efforts were ultimately successful does not diminish the fact that, when Pharmacia agreed to invest the time, money and opportunity cost to develop Dr. Bito’s discovery, the company was committing itself to an expensive and extremely risky proposition, with no assurance of making a profit or even recouping their losses. It was, in fact, a very long shot.

The folks occupying Wall Street ought to remind themselves that the cool products they are using each day (such as the iPhones they use to organize their flash demonstrations) all came about because the profit motive – and only the profit motive – encouraged some entrepreneur to risk his/her time, treasure, and sacred honor on some new idea. And for each risk-taker who becomes a millionare or billionare, thousands of others achieve only modest success – or fail altogether. (That’s why it’s called “risk.”) But the lure of big profits drives the whole system, and accounts for American progress.

Bito’s (tax supported) idea was a promising one, but the challenge of developing that idea into a product that was useful to patients and that could be brought to market was very expensive and highly risky. Pharmacia took on that risk (all of which was borne by its shareholders, and not by taxpayers) only after difficult, internal corporate soul-searching. If not for the prospect of making enormous profits if this risk worked out, the company (like several other drug companies did in this particular instance) certainly would have walked away.

Before 1980, it is likely none of this would have happened. The Bayh-Dole Act of 1980 was passed expressly to encourage the further development of federally financed, university-based basic research. Until then, a large proportion of basic university research was never “translated” into useful medical products. Such translation of basic research was recognized by Congress to benefit society not only by advancing the practice of medicine, but also by stimulating the overall economy. So industry was actively encouraged to take on the risk of developing promising ideas that came out of federally-funded research. And the profit that greeted successful enterprises was designed to be the one thing that would lure industry into taking that risk.

So when the Times “discovers” a company “profiteering” from work done with tax dollars, it should not be a revelation, nor should it be an unmistakable sign that the company is inherently evil or dishonest. Nor does the company’s activity in this regard give us a justification to arbitrarily restrict its profits. Rather, that’s simply the deal we taxpayers (through our elected officials) have made with the drug industry. We made this deal because we felt it would benefit American society, the American economy, American patients, and quite probably, us as individuals. Of course, if we want to change that deal now, it is within our rights to do so.

Without Bayh-Dole, perhaps patients with glaucoma would still be getting surgical therapy and wearing those coke-bottle eyeglass lenses instead of just using eyedrops. And if we wish to allow the Central Authority to put the brakes on such medical advances (ostensibly to prevent unseemly profiteering, but actually to stifle medical progress), we certainly can. It’s how covert rationing works.

But we shouldn’t vilify the drug companies for taking us up on the deal we offered them, back when we were thinking more clearly.

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.