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.

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

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

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&c.) are the price we pay when we insist on holding our leaders to the constraints imposed by some old, dusty, outdated document, written by someone else’s ancestors.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

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

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

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

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

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

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

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

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

Must be one of those Black Swan deals.

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

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

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

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

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

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

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

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

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

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

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

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

This law took effect January 1, 2005.

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

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

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

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

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

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

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

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

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

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

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

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

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

So let us begin.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

____

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

Say, whatever happened to those steel mills, anyway?

In his prior post, DrRich offered for your consideration a Brilliant Proposal that would assure at least some continued advances in pharmaceutical therapy, while at the same time providing the drug price controls which we all very much want, and which many (mainly those of the Progressive persuasion, who assert that the essentially evil nature of drug companies justifies any action we care to take against them) insist we deserve.

For those readers who have seen fit to e-mail and Tweet DrRich to complain that his Brilliant Proposal is not nearly punitive enough toward the drug companies, DrRich reminds you that, while cheerfully acknowledging at the very outset that drug companies are indeed evil, his Proposal attempts to balance that unchallenged fact against the (apparently lamentable) truth that, every now and again, one of these companies will inadvertently stumble upon a product that actually benefits people in a very substantial way. His plan proposes a method by which the price controls we all deserve can be established, while still allowing for occasional spurts of pharmaceutical progress.

DrRich’s proposal can be summarized as follows. Each American would formally elect to participate or not in a voluntary plan of price controls. Those who elected to participate would be entitled to receive any legal prescription drug at low prices set by a sympathetic government board, as long as the drug had been on the market for some fixed amount of time. (DrRich arbitrarily suggested five years, but that number could just as easily be set at 10 years, or any other value.) Those who choose not to participate in the price control plan would have to pay whatever the drug companies wished to charge them for all their prescription drugs – but they would be eligible to receive new prescription drugs immediately upon FDA approval (that is, the five- or 10-year waiting period would not apply to them). Finally, individuals would be able to change their status (from participant to non-participant, and vice-versa) only every two years.

Just as is the case with the more traditional drug price controls which many Americans are calling for, DrRich’s plan would achieve low drug prices (for anyone who elected to participate). But DrRich’s plan offers, in addition and in distinction, a mechanism by which pharmaceutical progress could continue, albeit at a much slower pace than we see today. That is, it allows for a population of Americans who are willing to pay full price for all their drugs in exchange for earlier access to new products. Thanks to these individuals, drug companies will be induced to continue spending something on drug research and development.

As a result, even those who choose to participate in DrRich’s price control plan would be able to count on a pipeline of new drugs, which would become available to them at very low prices after the mandated five or 10-year delay. This is a very useful feature that would not be available under the more traditional price control plans being advocated by most Progressives, such as the price controls being enforced in Canada today.

(Canadians, of course, today rely on a steady stream of new, relatively cheap drugs which are made possible only thanks to their Southern neighbors’ “willingness” to pay full price. DrRich’s plan, fundamentally, mimics the relationship between the US and Canada regarding drug prices. Those who participate in DrRich’s plan are the “Canadians,” and those who do not participate are the “Americans.” So in truth, DrRich is not actually inventing anything novel.)

So: All we need is to launch a grassroots movement to convince our legislators that this proposal offers all the benefits of the drug price controls which many Americans are insisting upon, without its major drawback (i.e., a complete stifling of pharmaceutical progress). Then, having done that, we will simply need to set up the sundry federal bureaucracies which will establish and administer the participation status of every American, and a government board that will set the official prices of all prescription drugs, and a few new enforcement agencies here and there, and of course some sort of administrative judge that can hand out exemptions to unions and other indispensable entities which would really like to have some new drug they’re not legally supposed to have. But with the kind of streamlining in federal processes and procedures promised to us under Obamacare, we should be able to implement DrRich’s plan pretty quickly and efficiently.

The Punch Line

There is, of course, a punch line.

Now that you have had ample time to digest the favorable implications of DrRich’s proposal, and can plainly see the wisdom behind it, you will be delighted to know that you don’t actually have to wait for federal legislation and the establishment of a vast new federal bureaucracies in order to participate. You can participate today, right now, with nobody’s acquiescence but your own.

Here’s how. Simply declare to yourself that DrRich’s system is already in place, and that you are a participant, and that the only drugs available to you are the ones that have already been on the market five or 10 years or longer. (You can choose your own personal waiting period.) When you see your doctor, insist – demand – that he/she prescribe only older drugs. The price of most of these drugs will be set not by a government panel, but by WalMart (which for many common generic drugs has set a co-pay of $4). By declaring yourself as boycotting the brand new drugs that are being sold (unfairly, of course) at the highest premium, your personal drug costs will be remarkably reduced – just as if federal price controls were really in place.

Furthermore, since currently there really aren’t any federally-mandated price controls, drug companies are not yet constrained from investing in the development of new drugs. As long as this situation continues, there will be a reasonably steady stream of new drugs exiting that magic five- or 10-year boycott period you have set for yourself, and thus becoming available to you under your personal, voluntary price control plan.

And best of all, if you were suddenly to develop a medical condition that clearly calls for one of the brand new drugs, one that wouldn’t be available to you, either temporarily under DrRich’s Brilliant Proposal, or ever under a government-mandated price control system (because under the government plan the drug never would have been developed in the first place), you won’t need to wait five or 10 years (or forever) to get that drug. Since you are really only “pretending” there are drug price controls, the moment you decide that a system of price controls is no longer accruing to your own personal benefit, you can simply ask your doctor to write you a prescription.

Those clamoring for government price controls on drugs can have them today – this very afternoon. They can experience every aspect of price controls (both low prices and the unavailability of new drugs) in a way that places them in no worse a position (indeed, in a far better position) than if government price controls were actually in place, and without reducing the options for everyone else.

Indeed, considering the above, the only way it would make sense to continue demanding mandatory price controls would be if something other than reducing drug prices were the chief motivating aim.

DrRich leaves it as an exercise for his regular readers to determine what that motivating aim could possibly be.

Evidence is building that our pharmaceutical industry is becoming diminished.

Recently, for instance. Pfizer announced a $2 billion cutback in R&D funding. One does not so massively trim R&D because of mere cyclical economic conditions; one only does this as part of a fundamental restructuring in business strategy.

Furthermore, the Wall Street Journal has noted that the big drug companies have entered a period of rapid acceleration in company mergers – but decidedly not in the manner of “creative destruction” that usually typifies such deals. Rather, it is being done in the manner of constructing a hardened shelter from which to hunker down for the coming nuclear winter, which they believe will be brought on by government-induced disincentives for innovation and growth.

Now, nobody needs to remind DrRich that drug companies are evil. DrRich has watched along with all of you as the pharmaceutical industry has fired off a never-ending parade of wasteful “me too” drugs, mainly aimed at keeping the joints, bowels, bladders and genitalia of aging baby boomers nicely lubed up, then running a steady stream (so to speak) of television commercials regarding same, which renders prime time TV far too embarrassing to watch with adolescents (especially if one is of a certain age).

Other evil behaviors abound. We can all see the drug companies systematically fail to publish research that makes their products look less than spectacular; routinely over-hype research that suggests a modicum of effectiveness; callously corrupt doctors with plastic, logo’d ink pens, and likewise corrupt legislators with huge campaign contributions and rides on private jets equipped with plenty of booze and bimbos (causing the indignant legislators to propose laws against logo’d ink pens); and most annoying of all, gouge American citizens with astronomical prices for their new drugs, while selling those same drugs to Canadians and other undeserving foreigners at greatly discounted prices.

But still, most objective observers must reluctantly admit that, every now and then, and most likely by mistake, a drug company will do something worthwhile. Here and there they manage to come up with a real breakthrough product that cures a disease, prolongs survival, restores functionality, or relieves suffering. That is, the pharmaceutical industry (in spite of all its evil behavior, which DrRich hastens to remind his readers he has formally acknowledged, as recently as in the prior paragraph), has done a lot of good over the years. Ask a parent whose child has survived acute leukemia, or the person who has survived a life-threatening infection, or the woman whose heart attack or stroke was aborted with clot-busting drugs, or – yes, this too -  the aging Lothario who once again can enjoy fine and durable erections upon demand. Such individuals, even if today they would join us in cheering on the demise of the pharmaceutical industry, have undeniably had their lives improved by drug companies.

So the question we must address before allowing the pharmaceutical industry to roll itself into a ball and hide in the shadows for the duration, is not, “What have you done for me lately?” (since their inventions will live on even if they do not), but rather, “What can you do for me tomorrow?”  Some of us in the boomer class, for instance, would like to think that current research in the areas of Alzheimer’s, Parkinson disease, kidney disease, heart attack, stroke, arthritis, osteoporosis and cancer will allow us to remain healthy and functional for a few extra years. And judging from the massive amounts of money American citizens of all ages donate to medical research of all types, it is apparently not held among the whole of the populace that medical progress has already gone far enough. Many of us would not be entirely pleased to stand pat right here. Many of us would like to see more improvements.

And here is where we run into a dilemma.

Everyone agrees that the cost of new prescription drugs has been kept obscenely high in the name of maximizing profits, and that the rising cost of drugs has been one of the prime drivers of healthcare inflation. Accordingly, we hear much talk of federal price controls, drug re-importation, more restrictive FDA policies, and other tools the Central Authority can employ to greatly restrict if not eliminate the huge profits made by the evil men (and, one must say it, women) who run these drug companies.

The problem, of course, is that if the potential for reaping large (obscene, if you insist) profits from new drugs is significantly curtailed, the hugely expensive process necessary for drug companies to bring new drugs to market will be proportionally curtailed. So if we place price controls on drugs, then we’d better be happy with the drugs we have today, because those are likely the only drugs we’ll have tomorrow.

There are some who would be quite satisfied with this outcome, and who would readily sacrifice pharmaceutical progress to keep costs down. Still, others of us appreciate the fact that every few years some truly earth-shattering drug will hit the market, and would think it a shame if progress on such drugs – even if they are but a few scattered islands in a sea of boutique pharmaceuticals – were to come to a halt, and even if for a good reason.

So here’s the question: Can we have our cake and eat it too? Can we bring down the price of the drugs we buy, while at the same time allowing at least some pharmaceutical advances to continue?

DrRich is delighted to reply, “Yes, we can!”

And he hereby humbly offers a plan to achieve this very end. It is a system of voluntary price controls. Of course, DrRich is talking here about us doing the volunteering – we the consumers – and not the drug companies.

DrRich’s Voluntary Price Control System works like this:

1) Each American will make a formal declaration of whether or not he/she wants to participate in a system of voluntary price controls on drugs.

2) Those who opt to participate will receive immediate, substantial discount pricing on all available prescription drugs, such pricing to be fixed by a sympathetic government agency whose makeup will include a wide diversity of representation, except, of course, that drug company representatives and their physician shills will be specifically banned.

3) “Available prescription drugs” under this price control system will be any drug whatsoever appearing in the U. S. Pharmacopoeia – that is, any legal prescription drug – as long as that drug has been on the market for at least five years.

4) Individuals who choose not to participate in the price control system will pay whatever price the drug companies feel like charging them for all their prescription drugs, but they will be allowed to receive any drug, as soon as it is approved for marketing, with no five-year waiting period for new drugs.

5) Individuals may switch their status (between participant and non-participant) only during one 30-day window every 2 years, determined by their month of birth.

Why DrRich’s Voluntary Price Control System is brilliant:

For drug companies it is the prospect of making large profits from new drugs, and only that prospect, that drives drug development. So as long as we want new drugs to be invented we’ve got to allow for the profit incentive to continue, as odious as we may believe that to be. The chief advantage of DrRich’s system is that it maintains at least some of the profit motive – to whatever extent citizens opt to be non-participants in the Voluntary Price Control System.

Given the growing hue and cry for price controls on drugs, one can confidently predict that only rich people will opt for this non-participant status. Therefore, a side benefit of this plan is that the rich – those who, after all, can afford it, and who, by virtue of the very fact that they are rich, owe much to the rest of us – will fund virtually all progress in drug therapy. Again, this is a burden they ought to feel obligated to bear, being rich and therefore obligated.

In contrast, under the universal, mandatory price control system of the kind that many Progressives seem to favor, the drugs available to our citizens would be essentially “frozen in time,” and henceforth there would be little or nothing new under the sun.

Of course, under DrRich’s Voluntary Price Control System, access to new drugs would be similarly restricted for participants. Yet this voluntary system would be far better for even those who choose to participate than would be a universal price control system – because under DrRich’s plan at least some drug progress would continue. And as new prescription drugs matured in the marketplace, and once their hidden dangers and side effects – during the 5-year “shakedown period” -  manifested themselves on the physiology of the wealthy (another great benefit of DrRich’s plan), these drugs would, eventually become available even to plan participants, and at a substantial discount to boot. And because only the rich will be harmed for the first few years, perhaps the FDA can relax its safety standards a bit, and pass a higher percentage of the effective drugs that are submitted for approval.

The bottom line: a five-year lag in gaining access to new drugs is vastly better than never having any new drugs at all, especially when the burden of paying for all that drug development, and the risk of becoming early adopters of new, relatively unproven, relatively risky pharmaceuticals, falls entirely on the undeserving rich.

So, while at first blush you may not like DrRich’s system – it being two-tiered and all – on further objective and logical reflection DrRich is confident you will see that it is far better for everyone than the universal system of price controls which many now want.

DrRich suggests you contact your legislators immediately to recommend to them this brilliant new plan, before it is too late. In making your case, you might remind your dedicated congresspersons that a robust pharmaceutical industry is inherently good for America, what with all the campaign contributions, airplane rides, booze, bimbos, etc. it provides to grease the wheels of American democracy.

When DrRich decided to become an electrophysiologist over 30 years ago, it was because he wanted to help figure out how to prevent sudden death.  Sudden death from cardiac arrhythmias is estimated to kill over 300,000 Americans each year, and at the time, some of the more recent victims of sudden death had been DrRich’s friends or loved ones. Because cardiac arrhythmias – even the lethal ones – can virtually always be stopped if appropriate interventions are available, these deaths can be prevented, at least in theory. DrRich wanted to help turn the theory into reality.

In 1982, by virtue of being in the right place at the right time rather than by virtue of his own qualities or qualifications, DrRich’s electrophysiology shop at the University of Pittsburgh became the third institution in the world (after Johns Hopkins and Stanford) to gain access to the highly experimental implantable defibrillator. The gradual development of the implantable cardioverter defibrillator (ICD) from a primitive and often dangerous device that was suitable only for the very highest-risk patients, to the finely-tuned life-saving instrument it is today, is an amazing story in itself. Perhaps some day DrRich (who was in the thick of it for two and a half decades) will try to tell it.

But the bottom line is that today we know how to prevent sudden death. And if the evolution of ICDs were permitted to follow the path which is followed by most modern technologies, these devices could, relatively quickly, become small enough, simple enough, safe enough, effective enough, and cheap enough for the kind of widespread usage which would be necessary to actually produce a large reduction in those 300,000 deaths per year. The ICD companies all know how this could be accomplished, and for that matter, so does DrRich.

But alas, this is not going to happen. ICDs will remain extraordinarily complex and expensive devices, which can only be wrestled to ground by highly-trained electrophysiologists (EPs), and which therefore will only be available to a very tiny proportion of the people who could benefit from them. And rather than being celebrated as the typical American success story of harnessing vision, persistence, and innovation to solve a very difficult problem, ICDs instead are widely castigated (by the press, the public, the insurers, the government, and even most doctors) as a symbol of excess, as the poster child for expensive and wasteful medical technology. (And so, when the DOJ goes after ICD companies and the doctors who implant them, the press and the people cheer them on.)

While most EPs and all of the ICD companies refuse to see it, ICDs – a remarkable technology which prevents an all-too-common tragedy – have become an abomination in the eyes of our society.

There are many reasons for this. DrRich will list just three of them, in ascending order of importance.

The third most important reason ICDs are an abomination is: The Toxic Symbiosis Between ICD Companies and Electrophysiologists.

EPs were important during the initial years the ICD was being developed, since expertise regarding complex cardiac arrhythmias had to be translated into engineering language, and then packed into the ICDs, in order for these devices to work the right way. But at some point in the 1990s, ICD companies should have realized that EPs had made their contribution, and were now leading them out on a limb.

Once the fundamental problems in building ICDs were solved, the companies should have been working to make their devices simpler to use, more reliable, and cheaper, so that they could be used by more doctors in more patients. Instead, following MBA Dictum Number One, they “listened to their customers,” the EPs. And the EPs (for whom, like most medical specialists, turf protection is very high up on their priority list), unfailingly counseled the ICD companies to make these devices more and more complex, so that only EPs can understand how to use them. And so, this is what the ICD companies did.

As a result, today’s typical ICD has extra leads (wires) which add appreciably to the difficulty and the risk of implanting these devices, without adding much practical value for most patients; and they have incorporated literally tens of thousands of programming options, ostensibly so that device function can be carefully “tailored” for the individual patient, but which are seldom actually used profitably, and whose chief effect is scaring off non-EPs.

By “listening to their customers,” ICD companies have been led away from simplicity and into unnecessary complexity, and today’s typical ICD is burdened with layers of grotesque tailfins, running lights, oversized tires, and massive engines. In building their vehicles, the ICD companies should have solicited the needs of the typical commuter; instead, they consulted only with monster truck enthusiasts, and so they are producing vehicles that are not suitable for highway use.

The second most important reason ICDs are an abomination is: Government Price Controls (As Usual) Are Keeping Prices High.

The price of ICDs, fundamentally, is determined by Medicare. Way back when ICDs were first approved for use, Medicare determined that a fair price was somewhere in the range of $15,000 – $25,000. This high price was justifiable back in the 1980s, since it cost nearly that much at the time to make one of these things. But the way government price controls seem to operate, ICDs will probably remain in this price range forever.

Now, to be sure, the government does not directly determine what companies get paid for ICDs. Rather, they indirectly determine the price by deciding what hospitals and physicians will be reimbursed for implanting ICDs – and the ICD companies subsequently are paid by the hospital. Those Medicare reimbursement rates apparently vary substantially from region to region and hospital to hospital (who knows how the government determines these things?), and the various rates are not publicly available to DrRich’s knowledge. But ICD manufacturers, at worst, can impute the reimbursement rates by figuring out the top price which specific hospitals are willing to pay them for ICDs (hence the range in prices).

Having determined the top price they can possibly get paid for ICDs, the only logical strategy for manufacturers is to figure out how they can always get paid that top price for every device they sell. They do this by making ICDs specifically aimed at keeping the decision makers happy. And the decision makers, as we have seen, are the EPs.

EPs, having (so far) successfully protected their turf, most often decide which patients get ICDs, and they decide which company’s ICDs to implant. So, to be competitive among their customers, ICD companies must cater to the wants and needs of EPs, and so must produce a steady stream of new, improved ICDs whose novel features are requested by these very high-end, high-maintenance physicians (who again, are dedicated to turf protection through complexity).

Since their product therefore grows more complex with each succeeding generation, in response to the “needs” of their customers, ICD companies have been able to successfully argue to Medicare that ICD reimbursement should be maintained at high levels (and in some cases they have been successful in getting reimbursements to increase even further).

All the ICD manufacturer needs (and wants) to know is: what new geegaws do I need to add to my next generation of ICDs in order to make them even more stupefyingly complex, so as to maintain the loyalty of my EP customers, and to justify high reimbursement rates?

And this is why, despite the fact that ICD technology has been fully mature (says DrRich) for at least a decade now, which in a functional market would cause the price to plummet, the cost of ICDs remains so high. Whatever has developed in the complex interplay between ICD manufacturers, EPs, hospitals and the government, it’s not a functional market.

In fact, there are no market forces at all in play here. Furthermore, there is no evil-doing. The “players” in this scenario – CMS personnel, ICD manufacturers, and EPs – are all simply behaving logically, and are all responding as anyone would to the incentives that have been established within a system which employs government price controlls to keep costs down.

As a result, ICDs remain extraordinarly and unnecessarily expensive.

And the number one reason ICDs are an abomination is: Sudden Death Is Good Public Policy.

A well-known and often-repeated assertion is that 75% (or some similar high proportion) of all healthcare expenditures are consumed during the last six months (or some similar brief interval) of life. Whenever this assertion is made, the clear implication is that some means ought to be found to stop wasting all those healthcare resources, once that six-month clock is found to have started. The debates as to how to go about doing this (since the initiation of the six-month clock can really only be determined retrospectively) often become very nasty, very quickly.

In this light, consider sudden death. Sudden death has the virtue of being completely unexpected – and therefore very cheap. Victims of sudden death will not have spent the last six months of their lives selfishly consuming all our healthcare resources. Likely, they will have spent that time earning money, consuming goods, and paying taxes. These patriots are doing what every healthcare policy expert agrees we should all do – to go directly from being productive citizens to six feet under. For sudden death is free, and if everyone did this we wouldn’t have a healthcare crisis at all.

Furthermore, consider the kind of patient who receives ICDs. Some of these, of course (probably less than 10%) are young individuals with some sort of genetic propensity for sudden, lethal arrhythmias. But by far, most people who get ICDs are older folks, generally in their 60s, who have underlying cardiac disease. These are people who, if their sudden deaths are prevented, will go on consuming large amounts of Medicare dollars for the maintenance of their sundry significant medical conditions, who will go on collecting monthly Social Security payments, and who, when the end finally does come (possibly a decade or more into their ICD-extended life) will do so in the classic American manner – in an ICU, supported by incredibly expensive machines, drugs, and medical professionals. And thus, thanks to their ICDs, 75% of their lifetime healthcare expenditures will also be gobbled up during their last days.

Consider also that there is no constituency for “sudden death.” There is a constituency for breast cancer; a constituency for HIV-AIDS, a constituency for muscular dystrophy; a constituency for autism; and even a constituency for flatulence. But there is no constituency for sudden death. People who die suddenly (all 300,000 of them per year) generally have no idea that they are likely to become victims of arrhythmic death, and don’t care one way or the other if the means are available to prevent this unfortunate event. Until, perhaps, the last five seconds of their life, they are entirely unaware that sudden death is even a remote possibility.

So the path is open to demonize ICDs and those who build or implant them, and to hound them into curtailing – if not stopping entirely – their counterproductive activities.

While ICDs are indeed too expensive and too complex, the chief reason they are an abomination is that they prevent the very kind of death that every health policy expert understands is the ideal. And they convert that ideal death into a years-long orgy of entitlement-consumption, capped off by a typically American, very non-ideal, very expensive kind of death. Small wonder that ICDs are being specifically targeted by the Feds.

Because of what they do, and not because of their cost, the use of ICDs must be curtailed. ICDs would be targeted even if they were as simple, cheap and reliable as DrRich thinks they could and should be.

ICDs would be targeted even if they were FREE.

Heck, the very concept of an ICD is an abomination.

Why Demonizing Obesity Is So Important

As regular readers will know, DrRich thinks President Obama’s healthcare reform is very bad for America, and in particular, that it threatens the Great American Experiment. At the same time, DrRich is fundamentally an optimist, and finds in Obamacare a thin thread by which some good might result. That thread goes like this:

In practice, Obamacare will become a government-run system of covert healthcare rationing. And DrRich is reasonably confident that in the government’s hands the covert rationing will become so amazingly ham-fisted and inept that even us Americans, distracted as we are by Lady GaGa, performance-enhancing drugs in baseball players, and Shark Week, will finally be forced to notice that there’s actually a whole lot of healthcare rationing going on. And once we are all forced to acknowledge the rationing, perhaps we will insist on trying to figure out how to do it as fairly, efficiently, and effectively as possible. In other words, DrRich clings to the hope that the Obamacare might end up being the cataclysm that precipitates a public discussion of healthcare rationing. And a public discussion of healthcare rationing is critical, since continuing to conduct the rationing covertly will destroy us.

It’s a slim thread, to be sure. But, especially in a new era of hope, one must embrace what hope one can.

Accordingly, DrRich feels obligated to do his part in supporting some of the main pillars of Obamacare (as odious as Obamacare itself may be), whenever they come under attack. And one of those pillars is the proposition that obesity is a scourge on our civilization, and for the good of the whole, those who are guilty of it must be reformed or stamped out.

Obesity, we are assured, is a main cause of heart disease, hypertension, stroke, arthritis, diabetes, (and even, some insist, cancer), and so is largely responsible for the runaway cost of our healthcare. This simple fact alone allows us to – indeed, demands that we – use every public and private intervention at our disposal to fight this great scourge.

The fact of publicly funded healthcare permits us to say to the obese: “Your unsightly obesity is no longer a matter of your individual choice; rather, it is now placed squarely within the realm of legitimate public concern. Since everyone else has to pay for your heart attacks and knee replacements, all those donuts and double cheeseburgers you insist on shoveling into your mouth are no longer your business. All your protestations to the effect that you can’t help it are revealed by simple math (i.e., calories gained = calories consumed minus calories burned) to be sad prevarications. Indeed that same simple formula reveals the true cause of obesity – gluttony and sloth. Like other heretics of an earlier time, you deserve no sympathy nor special considerations, but only a firm – though ultimately compassionate – hand to push you toward the right path, or alternately, toward the just punishment you have brought upon yourselves.”

So clearly, the obese are now become fair game for whatever manipulations our government can devise to cause them to either lose weight, or pay for their sins. The authorities can begin with simple maneuvers – taxing soft drinks and Twinkies, and whatever other foodstuffs they (in their wisdom) deem to be illegitimate sources of calories – but the sky’s the limit. For instance, under the undeniable proposition that it costs more energy to move a fat person from point A to point B, whatever the mode of transportation, the obese could be subjected to a special carbon tax, based on their BMI. The periodic mandatory “weigh-ins” such a tax would require would serve the useful purpose of public humiliation, an important incentive to weight loss.

Further humiliations could be visited upon the fat by designating special isolated areas in the workplace (ideally, an area fully exposed to the elements) for fat people to consume their calories. This latter strategy, of course, is derived from the same restrictions placed on smokers, and can be legitimized by the same sort of logic. That is, the authorities can invoke the prospect of second-hand obesity to induce fear and loathing of the fat, and cause them to become socially isolated. (The “scientific” conclusion that obesity is contagious, i.e., that those who associate with the obese are more likely to become obese themselves, has been proffered by academics employing the same kind of statistical legerdemain used to blame global warming on fat people. It appears to DrRich that obesity has now become so toxic that any paper submitted to medical journals offering a new reason to despise the fat – no matter how absurd – will be cheerfully accepted by the editors, and published with fanfare. These editors, one can only presume, must also be great supporters of Obamacare.) And finally, it goes without saying that the ultimate censure would be simply to withhold healthcare services for medical problems which can be associated with having allowed oneself to become too fat – a strategy that has already been employed by the British healthcare system, which we are urged by Dr. Berwick to employ as a model.

Demonizing the obese and subjecting them to such restrictions, of course, carries with it implications that go far beyond merely inducing the obese to lose weight or causing them to pay more in taxes. It sets an important precedent that will finally allow our central authorities to restrict, control and tax virtually any human behavior they can claim may lead to an increased risk of healthcare expenditures. Such behaviors may include (in addition to obvious things like smoking and alcohol consumption), one’s choice of occupation, participation in sports, hobbies, hours spent or miles traveled on the highways, etc. Indeed, it is difficult to conceive of any choice one makes in daily living that does not, in some manner, impact on one’s likelihood of requiring medical services.

Furthermore, successfully demonizing the obese will establish that our society may, whenever it needs to, discriminate against the lower economic classes – which will prove a useful tool when setting future behavioral standards to reduce healthcare spending. (Obesity, rather than starvation, is the chief nutritional problem of the poor in America. This is the the direct result of plentiful and cheap foods that are often loaded with empty calories. Making such foods more expensive – by imposing punitive taxes on them – will disproportionately affect the poor, who still won’t be able to afford the highly nutritious stuff, especially since the price of that good stuff will go much higher as a result. Rendering it permissible to inflict such pain on the poor, in the name of the greater good, will be an immeasurably important precedent to establish.)

In terms of providing strategies for controlling healthcare costs, it is clear that our response to obesity is key. Fighting obesity is a vital pillar of Obamacare.

Accordingly, DrRich is very sorry to report that this anti-obesity pillar may not be nearly as robust as we might hope. Certain clueless medical researchers – ones who have apparently not received the official memo – have been reporting that obesity might not be quite as bad a thing as we have all been saying. So, in the spirit of advancing Obamacare, DrRich will address in his next post some of this counterproductive new research on obesity, and will show how it can be marginalized.

While President Obama, Speaker Pelosi, and a few other stalwarts seem to understand that passing healthcare reform would be worth almost any price that might be extracted by the electorate in November, less principled (and more at-risk) members of Congress, who are apparently less dedicated to a certain ideology than their leaders, apparently see it another way.

And so, from all appearances, things appear to have stalled on healthcare reform.

But while our political leaders seem willing at this moment to take a breather – either to lick their wounds and regroup, or to celebrate an important tactical victory – one interested party in the healthcare reform wars cannot afford to rest.

That would be the health insurance industry.

As DrRich has pointed out before, the health insurance industry is the one entity that simply cannot afford to wait. They need healthcare reform now.

The health insurance industry has pretty much run out its string. The era in which insurers can increase their market cap by acquiring public assets (i.e., non-profit institutions) for a fraction of their true value, and by making mergers and acquisitions, is pretty much over. For the past few years insurance companies, for the first time, have had to try to make a profit by taking care of sick people. They have never done that successfully, and never will. They have tried every underhanded trick imaginable to avoid paying benefits to their subscribers. They have already raised insurance premiums to the very breaking point. But an uncooperative public insists on getting older and sicker, and greedy drug and medical device companies insist on bringing ever-more expensive technologies to the clinic. The insurance industry finds its profit margins (already small) rapidly eroding. The industry’s business model – taking in inflated insurance premiums, then attempting to withhold medical services – is irreparably broken.

As a result, what the health insurance industry needs more than anything else is a graceful exit strategy. And Mr. Obama’s healthcare reforms promised them that very thing. (What, exactly, they have been promised is largely a matter of conjecture, but most likely they will take on a role in administering government-funded healthcare, quite possibly assuming the role of a public utility.)

Whatever may be the particulars of the “deal” the health insurance industry struck with the reformers, that deal offered them enough to purchase their silence during the entire roiling debate over healthcare reform through the summer, fall and winter. They have stoically (almost cheerfully) accepted their assigned role as “villain” in this set piece, and have silently borne the public “attacks” the President and his soldiers have dutifully launched against them in an effort to drum up support for their reforms. All the nasty things the Democrats have said about them, the industry understands, are necessary components of their last best hope to salvage something serviceable out of their broken business model. No Harry and Louise this time!

Despite this symbiotic relationship, the reforms envisioned by the Democrats and the insurance industry have now faltered. The stalling of the reforms, however, means very different things to these partners.

For the Democrats, while abandoning, or even substantially diminishing, the ambitious reforms they had in their sights might prove modestly embarrassing for a time, such is the nature of politics. When one overreaches, one pulls back and waits for a while, until the other side overreaches. Look at where the Republicans were just a year ago. A year or three from now, they may be back in a similarly diminished state – and the time for passing healthcare reform may again become propitious. If you’re a Democrat politician, you must take the long view.

But the insurance industry does not have that luxury. They are at the end of their tether, and their only alternative to a graceful exit strategy of the type (whatever it was) the President promised them, is a completely graceless one. Whatever happens or doesn’t happen with healthcare reform, the insurers can’t keep doing business as usual. DrRich believes the health insurance industry has been backed into a corner, and the doorway the Democrats were making for them is being nailed shut.

In such a situation, it is entirely predictable that the insurance industry will take some kind of drastic action, to try to force healthcare reform back on the table.

And last week, Wellpoint did so. Wellpoint’s California subsidiary, Anthem Blue Cross, announced it is raising its already-astronomical health insurance premiums by as much as 39%, a move that promises to greatly increase the number of Californians who are uninsured.

Kathleen Sebelius immediately fired off a public letter to the company, demanding that they justify this unconscionable rate increase. And Wellpoint, lustily assuming its assigned role as villain, was delighted to comply. We’re in a recession, Wellpoint brazenly asserted, and in a recession, like it or not, people exercise their prerogative to drop their health insurance. The only people who don’t drop their health insurance are the sick people or those who are likely to become sick, which means that our cost per subscriber goes way up. So naturally, we have to increase premiums. By a lot. It’s just business. That’s just the nature of our current, unreformed healthcare system. So choke on it.

Wellpoint was also kind enough to mention (for anyone dense enough to have missed the point) that the need for higher premiums would be nicely mitigated if everybody was mandated to purchase health insurance.

Wellpoint’s premium increase immediately triggered great volumes of delighted outrage by thankful Democrats, who really need a large dose of “evil insurance company” right about now, but it elicited only a few lame and uncomfortable attempts by stunned Republicans to diminish the significance of the unfortunate action.

DrRich would like to point out that, from a pure business standpoint, there was no good reason for Wellpoint to stir the soup at this moment. Wellpoint is the most financially sound private health insurance company. While its California subsidiary did lose money last year, overall the company performed quite well, and reported a very nice profit growth for the year. And with several of its competitors in trouble, Wellpoint stands to do comparatively well for the foreseeable future. So it stands to reason that, if Wellpoint really wanted healthcare reform to go away, they would have waited a few months before announcing their rate hike. It would have cost them very little to do so. The last thing they would have done is to throw the reformers a critical lifeline just as they were going under for the last time.

Wellpoint’s astounding premium increase was, DrRich submits, a strategic move to push health insurance reform back to the front burner.

The Republicans, many of whom believe that the failure of Obama’s healthcare reform will spell the failure of his presidency, have been thereby served notice. An angry electorate – which, at the moment, seems ready to punish Democrats for their attempt at passing an unpopular government takeover of healthcare – is likely to become even angrier if it turns out that the failure to reform healthcare will give the haughty insurance companies the green light to price even more millions of hard-working Americans out of the health insurance market. That species of anger will be directed toward the Republicans, and not the Democrats.

DrRich has always maintained that if healthcare reform is to happen, despite the incompetence of the Democrats who control everything, the reason it will happen is because the insurance companies cannot survive without it.

Accordingly, Republicans who understand what Wellpoint is telling them will think twice about skipping President Obama’s proposed bipartisan summit on healthcare, or behaving intractably if they do show up. If they fail to get the message, DrRich suspects that we will soon be hearing about additional, even more astounding, rate hikes.