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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.

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In Durango, Florida the week before Christmas, the FBI arrested fugitives Roger Gamlin, 62, and his wife Peggy, 54, at Mercy Regional Medical Center after a doctor determined their real identities through Roger’s pacemaker.

Wanted by the feds for 2 1/2 years on suspicion of embezzling millions of dollars from their south Florida title company, Roger and Peggy had been living quiet and unassuming lives as Ron and Nancy Jenner in Durango.

Then Peggy brought Roger to Mercy Medical Center after he developed a nose bleed that would not stop. The hospital (in accordance with the sage advice of its attorneys) is not saying exactly what happened next. But we know that Roger’s true identity was determined through his pacemaker, and the FBI quickly showed up to arrest him and his wife. Roger and Peggy waived their rights to an identification and detention hearing, were placed into custody, and will be transported to south Florida to face embezzlement charges.

The reason this story made the newswires, of course, is because the fugitives were identified through a pacemaker. Pacemakers can be electronically scanned to reveal information about the patient’s cardiac condition. Every implanted pacemaker also stores information that identifies the patient. That’s apparently what did Roger and Peggy in.

The “angle” that has made this a news story is the pacemaker angle. And yes, it’s true that when you receive a pacemaker or an implantable defibrillator, it’s like receiving a subcutaneous electronic identity chip, like the one you have in your dog. Anyone with the right scanner can find out who you are. So if you plan to become a fugitive from the law, it is best not to have one of these. (Alternately, get your pacemaker AFTER you change your identity, so that it matches with your alias.)

But really, you don’t need to have an implanted medical device in order for a hospital to learn your true identity. A medical facility could find out who you are any time they wanted, by surreptitiously obtaining DNA samples, for instance, or – for extremely rapid identification – dusting your drinking cup for fingerprints and doing a computer match. DrRich doubts whether such things are occurring today. His point is that it could happen whenever somebody wanted it to happen, whether you have a pacemaker or not.

To DrRich, the interesting part of the storyline only peripherally involves the pacemaker. The real story is this:

• A patient goes to a hospital for medical help.
• A medical procedure is done which generates certain data for the medical record.
• The data in the medical record is immediately cross-referenced with data from a federal database that lists persons of interest.
• The FBI shows up at the bedside in less time than it takes to raise a nurse with a bedpan.

Now, that’s actually a pretty interesting story.

(And people wonder why the Central Authority is so hot to have electronic medical records.)

But even that is not the most interesting angle. What DrRich wants to know – the angle he would explore if he were writing this up for the Sunday Times – is: What was the doctor thinking?

You’re an ER doc. A guy comes in with a bad nosebleed. You stabilize the bleeding, but the guy looks pretty pasty and you’re worried about his heart, so you interrogate his pacemaker. (Here’s the first red flag. For an ER doc, interrogating a pacemaker – not a routine procedure in most emergency rooms, and one which yields only sparse information about the status of a patient’s heart – is generally pretty far down the list of things to do. Could it be that Roger is acting suspiciously, and you want to find out whether he is who he says he is? If so, you are no longer acting as a doctor, but as an agent of the government.) In any case, whether intentionally or not, you learn that the patient has checked in under an alias.

So now what do you do?

There are some things you need to consider as you decide what to do. First, you have established a doctor-patient relationship with Roger, which binds you to confidentiality – unless you believe Roger is an imminent threat to himself or others. But simply using an alias does not constitute an imminent threat to anyone. Besides, using an alias is not necessarily illegal. Samuel Clements used one, and so do most people who work in Hollywood. And how many times has Barack Obama changed the name he answers to?

Second, you yourself might get into trouble if you look into the matter. For instance, if Roger were an illegal alien and you took it upon yourself to escalate the matter of false identity, you could get into serious trouble. After all, the U.S. Attorney General has determined that an Arizona law is unconstitutional which would permit police officers to investigate the actual identities of suspected illegals who are detained for other offenses. And you are not even a police officer, and Roger is not being detained for an offense, but has come in to seek medical assistance. Furthermore you are well aware that if a suspected illegal alien shows up in your ER, you are supposed to treat him/her without asking any questions about identity or legal status.

But you determine that Roger does not look Hispanic (or Arabic) – a determination that by any reasonable definition would constitute racial profiling – and so is not likely to be a member of a protected group.

DrRich thinks you are thinking like this: “This man is obviously using an alias – so what is my obligation here? In the old days my obligation would be to honor the confidentiality of my patient, who, for possibly very legitimate reasons, has altered his identity. But it’s not the old days. Now, I’m obligated to do what’s best for the collective, and only secondarily what’s best for this patient. I suspect the collective would like to know about this guy, to check him out. It’s a little risky – what if he turns out to be an illegal from, say, Argentina? A lot of people from Argentina look European. But that risk seems small, and if he is some kind of fugitive from the law I would be doing a great service to my overlords.”

So you rat him out.

We indeed have come a long way. Not only have our doctors apparently lost their scruples, but we also appear to have already arrived at a place where medical records can relatively seamlessly interface with other federal databases. Once medical records become fully electronic, patients needing medical aid will have a lot to consider. Are you an embezzler on the lam? Are you behind in paying your income taxes? Are you a parking ticket scofflaw? Do you have erectile dysfunction, or venereal disease? (These latter conditions cannot get you arrested – as of yet – but we know that all databases controlled by the government, no matter how “confidential,” also interface seamlessly with WikiLeaks, and so the publication of lists of patients with embarrassing medical conditions always remains a possibility.)

Once again, DrRich marvels at the fact that, soon, the only safe way to get your healthcare will be through the black market.

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Thanks to Ms. Wood of the Occam Practice Management Blog for calling DrRich’s attention to an interesting article appearing recently in the Wall Street Journal Health Blog. This article describes the efforts of a non-profit organization called the Investor Protection Trust to (it appears) medicalize the problem of financial scams involving the elderly.

Specifically, under the auspices of the IPT, government securities regulators will be teaming up with physicians organizations (in particular, the American College of Physicians and the American Academy of Family Physicians), to train PCPs to recognize signs that their elderly patients are victims of financial fraud or exploitation. If such fraud is uncovered or suspected, the physician is to notify Adult Protective Services, an organization which (helpfully) is not subject to certain annoying confidentiality regulations. IPT estimates that screening for financial abuse can be accomplished by adequately-trained PCPs in only three short minutes.

The plan is to have PCPs take special training to help them recognize the signs of financial elder abuse. This training can be accomplished in only two hours, the IPT explains, and will be conducted “under the auspices of medical ethics continuing education.”

Long-time readers will know that DrRich is the President (and sole member) of Future Old Farts of America. (He retains this position despite the fact that his eligibility for FOFA is rapidly expiring, and, some have suggested, has already expired.) As President of FOFA, DrRich naturally deplores financial fraud perpetrated upon the elderly. Indeed, this is one of the chief reasons he opposes Obamacare.

So DrRich applauds this new effort to protect the fiscal wholeness of our beloved elderly. The plan is flawless, as it has something good in it for everyone – except, perhaps, the PCPs.

The IPT itself stands to gain much from this new program, since this organization is funded through fines collected from investment-fraud cases. Having American PCPs embark on a major, sustained, grass-roots effort to troll for such investment fraud (using screening criteria developed by the IPT itself) should greatly increase this organization’s revenue.

The major physicians organizations which represent PCPs – the ACP and the AAFP – also come out ahead by supporting this effort. They reap, of course, all the public relations benefits that always go along with new programs aimed at assisting our esteemed elderly population. But perhaps more importantly, their participation in this program helps them with the small “ethics problem” they have lately created for themselves.

As regular readers will know, the ACP and AAFP are major proponents – and indeed the authors – of the New Age medical ethics that was formally adopted by the medical profession in 2002. This new ethics, as DrRich has patiently explained, obligates physicians to strive to practice medicine for the benefit of the collective. Practically speaking, the “new ethics” creates the ethical foundation by which American physicians will practice medicine according to fiats handed down by government-controlled expert panels. That is, it excuses physicians from their now-obsolete obligation to always do what’s best for the individual patient, in favor of doing what’s best for society as a whole, as determined at a distance by the Central Authority.

All well and good. As DrRich has amply demonstrated, the ACP (at least) is quite satisfied with its new medical ethics, and sees no reason to reconsider. But still, this creates a problem for the ACP when it comes to “medical ethics continuing education.” Thoughtful physicians, when faced with indoctrination programs aimed at getting them to absorb the new medical ethics, often raise uncomfortable questions, questions which (as, again, DrRich has shown) even the chairperson of the ACPs’s ethics committee cannot effectively answer. Clearly then, having formally tossed real medical ethics aside has undoubtedly made these ethics sessions somewhat awkward for the instructors.

What better solution to this embarrassing problem than distraction? Simply turn these annoying continuing education sessions into something other than a discussion of medical ethics.  Turn it into, say, a two-hour session on recognizing financial fraud among the elderly. You’ve got to have something to talk about, after all – and defrauding the elderly is unethical, is it not?  It is not hard to understand why physicians organizations are so supportive of the IPT’s new effort.

But, of course, the very first among the beneficiaries of the medicalization of elder fraud is the government.

Most directly, anything that helps to keep the estates of the (pleasantly) befuddled elderly intact, until they pass on to their more permanent rewards, will increase revenues to the state and federal governments through inheritance taxes.*

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*DrRich leaves it to the reader to decide whether the benefits to the overall economy are greater if the accumulated wealth of the elderly is passed on to the government, or to perpetrators of fraud. Which entity – government or crooks – is more likely to make use of that money in a truly stimulatory fashion? It boils down to the old argument between Keynes and Hayak, of course. In the interest of both brevity and civility, DrRich declines to take up this argument at the present moment. Still and all, it is indeed a point for consideration.
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But the government – and any healthcare payer – benefits immediately from this new program, even before the elderly person dies.

A major strategy in cutting the cost of healthcare – THE major strategy – must always be directed toward controlling the behavior of PCPs. This strategy, for instance, fully explains the massive tangle of uninterpretable rules and regulations which the PCP must painstakingly navigate today, the violation of any one of which is now a federal crime punishable by massive fines and imprisonment. Another tactic for controlling the PCP’s behavior is to severely constrain their face-time with patients, and to tightly regulate what must occur during these now-brief doctor-patient encounters.

Accordingly, during the 7.5 minutes allotted for each patient visit, the PCP must complete a 10-to-15-point checklist of required activities that fall under the rubric of “Pay for Performance.” Such checklists are designed, among other things, to keep the PCP and patient from straying off to address medical questions which do not appear on approved lists, and which might lead to unfortunate medical expenditures.

From the government’s standpoint, adding yet another obligation to the PCP’s critical checklist – an obligation which is so obviously beneficial to our elderly citizens, and which after all takes only three minutes to complete (leaving a full 4.5 minutes for actual medical issues) – is a very useful thing. And furthermore, it is the right thing. Anyone objecting to PCPs being directed to screen for financial abuse in their elderly patients immediately reveals themselves to be completely heartless and unfeeling and, likely, a Republican.

The PCPs, of course, are the only losers here. They are being asked to add yet another impossible task to their already-impossible list of jobs. Furthermore, as we have seen, once some outside body declares that it is the PCPs job to accomplish some impossible new task (such as assuring that all of their patients actually quit smoking), then our friends in the legal profession can immediately begin suing PCPs who fail to accomplish it.

So now the adult children of neglected elderly parents, finding that their inheritance has been frittered away because someone talked Pap-Pap into having a new roof installed on his house every year, will have somewhere to go to recover their damages.

If, as has been DrRich’s contention, the ultimate goal is to render primary care medicine so very odious, demeaning, exasperating and dangerous as to become a completely untenable proposition for any self-respecting American physician, so that by default the role of PCP will have to be filled with lower-level professionals who presumably will be more accepting of central directives, happier with checklists, and more comfortable with time-clocks than most doctors ever could be, then this new initiative is more than just a good idea. It is truly inspired.

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Q. What’s the difference between a public health expert and an incompetent doctor?
A. An incompetent doctor tends to kill only one person at a time.

The deep recession and jobless “recovery” which we have enjoyed in the U.S. for going on three years now was triggered by the bursting of the housing bubble. The housing bubble was created by lending practices that awarded “subprime” mortgages to people with bad credit ratings, and offered to people with good credit ratings adjustable-rate mortgages (ARMs) that enticed them to purchase more expensive homes than they could afford.

Traditionally, banks were always reluctant to award mortgages, of any flavor, to people who obviously could not afford them, since doing so would wreck their businesses. The reason the banks began making bad loans in the 1990s is that new government policies, chiefly the Community Reinvestment Act, strongly “encouraged” them to.

The banks, being businesses, reacted logically to the new regulatory climate, to threats by ACORN and other activist groups, and to the escape hatch opened for them by the government which allowed them to turn over their toxic mortgages immediately to Fanny and Freddie.  Banks quickly began turning out as many questionable mortgages as they could write, to as many uncreditworthy individuals as they could find.

Fannie and Freddie, in turn, securitized all those bad loans into complex investment instruments, which they released into the general worldwide marketplace. Investors around the world were happy to take these questionable new instruments since Fannie and Freddie, tacitly at least, were backed by the United States government.

And so, when the unqualified homeowners, who never had any prayer of making long-term payments on their mortgages to begin with, proceeded (at the very first and gentlest whiff of a recession) to default on their loans, the whole structure rapidly collapsed, nearly causing a global financial Armageddon.

Thank goodness us U.S taxpayers “volunteered” to clean up the whole mess with our taxes and those of our children and grandchildren.

There’s plenty of blame to go around for causing the mortgage crisis. We can blame all those people agreeing to mortgages they could not afford, the banks pushing mortgage deals on people who clearly did not understand what they were getting into, and Fannie and Freddie infecting the worldwide investment structure with toxic instruments. But the root cause was bad government policy.

Establishing policies that compelled banks to award mortgages to people who could not afford them (in order to advance the noble goal of creating a nation of homeowners) may seem like a compassionate thing to do. But the laws of economics are like the laws of nature. You can’t change them by government fiat. All you can do by fiat is to get people to behave in new and possibly unpredictable ways. And when those irreducible economic laws finally come around to assert themselves, you will be surprised, and likely dismayed, by the result.

As it turns out, setting health policy can have much the same kind of result. If you fail to pay sufficient attention to certain irreducible laws of nature – such as the laws of human behavior, and the laws of human physiology – you may not get the effect you are looking for (or, at least, not the effect you say you are looking for).

And this brings us to the obesity crisis.

Whether or not you agree that obesity is a “crisis” in the U.S., or even that mild to moderate obesity is the medical disaster it’s often painted to be, you’ve got to admit that Americans have gotten substantially fatter over the past few decades. And whether or not our increased corpulence is a grave threat to life and limb, it is creating an opportunity for the government to seize control over our individual freedoms – so it is, in fact, an important phenomenon.

DrRich is not the first to suggest that the public health policies of that very government substantially contributed to our obesity crisis. But as we enter a new era of Progressive healthcare, in which medicine is going to be practiced by policy fiats instead of by individual decision-making, it serves us to remind ourselves just how much the obesity crisis is tied to the great push, instigated by government policies dating back to the 1970s, for everyone to eat low-fat diets.

An association between dietary fats and coronary artery disease was first noted in the 1950s. In 1957, the American Heart Association (AHA) published its first, tentative recommendations for limiting the consumption of saturated fat. The recommendations were specifically aimed only at people who had strong genetic predisposition to heart attacks or strokes, or who already had heart disease. An accompanying editorial by Herbert Pollack, in the August, 1957 issue of Circulation, specifically warned against the widespread application of the recommendation to avoid saturated fat:

“Altering the dietary habits of a large population group is fraught with a great many dangers. Our knowledge of nutrition is not sufficient at this time to anticipate what ultimate results would happen if the public were encouraged to alter radically their basic dietary patterns.”

The AHA’s recommendations regarding saturated fat in the diet received sparse attention for 20 years. Then in 1977 (during arguably the second most Progressive administration in our history), the Senate’s Select Committee on Nutrition and Human Needs, chaired by George McGovern, nationalized the question of fat avoidance. After holding a series of hearings which tied fat consumption to heart disease, the Committee published the first “Dietary Goals in the United States,” advising all Americans to cut back on fat consumption. With this report, the US government officially supported low-fat diets for everyone.  (The public then was judged to be just as stupid as we are judged to be today, so any real effort to distinguish between unhealthy fats and healthy fats was quickly set aside. “Fat is bad” is a message you can sell even to gun-toting Bible-thumpers.)

The anti-fat boulder got a great big push down the hill in 1983, when the Framingham study published a landmark paper tagging obesity as an important risk factor for cardiac disease. Because eating a diet high in fat obviously caused obesity, it seemed self-evident that low-fat diets would prevent heart disease both directly, and indirectly (by preventing obesity).

Accordingly, in 1984 the NIH issued a Consensus Statement entitled “Lowering Blood Cholesterol to Prevent Heart Disease,” which amounted to an all-out attack on dietary fat. Many scientists pointed out that there really was a lack of convincing evidence demonstrating that low-fat diets would be healthful. But the majority, seeing an epidemic of heart disease which must surely be due to fatty diets, outnumbered the reticent ones, and the Consensus Statement was voted into publication. Then, when the AHA abandoned its earlier caution and endorsed this Consensus Statement, the scientific backing for the government’s public policy encouraging low-fat diets for everyone was fully in place.

This action finally ignited the great low-fat diet era. Spurred on by government policy, prestigious medical organizations and others began a campaign of public service announcements and media blitzes. Influential magazines (that is, magazines read by women) began a prolonged onslaught of low-fat diet tips, articles, and human interest stories emphasizing the deadly nature of dietary fat. The food industry, which was at first very skeptical (like the banks when subprime mortgages were initially foisted upon them), finally jumped in with both feet. A massive new product line of low-fat and no-fat snack foods were invented which were just packed with carbohydrates, and often with supposedly “healthy” man-made trans fats. (This major shift in food production has been referred to as the “Snackwell phenomenon.”) The AHA found a lucrative new revenue source officially certifying such low-fat, high-carb products (including Frosted Flakes and Pop-Tarts) as being “Heart Healthy.”

Americans, being filled with the milk of human nature, largely ignored the ubiquitous pleas to abandon their burgers, pizza and tacos in favor of broiled, skinless, sauceless, saltless chicken breasts and broccoli. But they did begin scarfing up the new-age low-fat snack foods in massive quantities, having been assured that, as long as the snacks contained no fat, they could eat as much as they wanted.

There are a few physiological facts about dietary carbohydrates that were largely ignored during the low-fat era. First, the body greedily converts dietary carbohydrates into massive stores of adipose tissue, so indeed you can readily become fat by eating carbs. Second, gorging on the refined carbohydrates found in these new “healthy snacks” causes huge spikes in insulin levels (insulin being a key factor in converting excess carbohydrates to fat).  When the insulin levels suddenly drop a couple of hours later, that drop produces insatiable hunger. So, two or three hours after enjoying a fat-free Pop-Tart or a Snackwell cupcake, one is ripping the cubboards open to find another carbohydrate fix. By thus inducing a continuous-snacking mode, the new high-carb snack foods increased overall caloric intake far beyond the calories listed on their labels.  Third, diets high in refined carbohydrates increase triglyceride levels, reduce HDL cholesterol (“good cholesterol) levels, and in general create lipid profiles that are quite damaging to the arteries.

So, while few people actually stuck to a strict low-fat diet, many, many people became addicted to refined carbohydrates, and as a result became fat.

It has only been in the past five or six years that the low-fat dogma has begun to moderate, largely thanks to the (now mercifully faded) low-carb craze that struck at that time.  We now hear somewhat more reasonable advice about good fats and bad fats, and good carbs and bad carbs. But much of the damage has been done, and at least partially because of the major push for low-fat diets, we Americans are fatter and less healthy than we used to be.

By the way, to this day it has never been shown that low-fat diets applied across the population would reduce the incidence of heart disease.

The low-fat diet policy amounted to a massive public health experiment, with the research subjects being us. Our government and our scientific organizations have yet to apologize for subjecting all of us to this travesty.  Indeed, like the outcome of the great experiment in subprime mortgages, the outcome of the low-fat experiment is not particularly chastening to our Central Authorities. In fact, it works to their advantage.

To see why, consider the final way in which the obesity crisis is like the mortgage crisis. To prevent another mortgage crisis, our government, in its wisdom, did not promise to avoid promulgating any more counterproductive economic policies that will force businesses and individuals to act in harmful ways. (In fact, government policy continues to coerce lending to unqualified individuals.) Rather, they passed massive new “financial reform” legislation aimed at preventing banks and other financial institutions from behaving logically in response to bad government policies. The cure for bad regulation is more bad regulation. And when the results of its own bad regulations created an opportunity to grab even more control over the marketplace, our government lept at the chance.

Similarly, having (probably inadvertently) made policies that resulted in a fatter, less healthy populace, our government is now poised to take advantage of that opportunity, to turn the purportedly grave danger posed to the nation by the obesity crisis into a mandate for assuming powerful controls over the prerogatives of individual Americans.

And now, having learned that, like bad economic policy, bad public health policy can get them to where they want to go, our Progressive leaders are turning their attention to the next great public health initiative. Far from apologizing to us for the damage they caused with their low-fat experiment, they are plotting the next great experiment in public health which they will perform upon the population.

It appears it will have to do with salt.

Podcast:

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.

Podcast:

DrRich’s last post addressed a recent issue of the Archives of Internal Medicine which, strikingly, was largely dedicated to trashing the JUPITER study.

The JUPITER study was a landmark clinical trial in which giving the statin drug Crestor to apparently healthy individuals who were at increased risk of cardiovascular disease (and most particularly, had high CRP levels) resulted in a significant improvement in outcomes. In particular, within two years, individuals taking the statin had a 20% reduction in overall mortality, a 54% reduction in heart attacks, a 48% reduction in stroke, and a 40% reduction in venous thrombosis and pulmonary embolism. All these findings were highly statistically significant.

DrRich attempted to show that the criticisms of JUPITER recently offered by the Archives were sufficiently spurious to raise the question of what the authors and the editors were really trying to accomplish, and for him to suggest that perhaps they were auditioning for appointments to the government’s expert medical panels, which will soon begin determining who gets what, when and how. Indeed, DrRich will actually be quite surprised if none of these individuals end up with such an appointment. They have clearly demonstrated they have the right stuff.

Still, as DrRich also pointed out, the JUPITER study, while a reasonably straightforward clinical trial whose results seem impressive, was anything but air-tight. No clinical trial is air-tight, however, and if medicine were still practiced the way it should be, the JUPITER trial could be smoothly incorporated – with all its limitations – into clinical practice without a hitch.

But, since medicine is now practiced by guidelines, JUPITER poses a major problem. In fact, it has led to major and contentious debates between those who insist its results must be incorporated into formal clinical guidelines, and who insist they should not. On one hand, many point out that JUPITER is an important clinical trial which has demonstrated a vital clinical benefit (prevention of heart attack, stroke and death) with a high degree of statistical significance, which meets the high standards demanded by evidence-based medicine, and which therefore obviously demands a change in the clinical guidelines. But on the other hand, many others insist that the JUPITER trial simply does not demonstrate enough of a benefit with Crestor to justify changing the guidelines.

DrRich’s position – that the results of the JUPITER trial are striking and important but incomplete, and ought to change the conversation between, but not dictate the actions of, doctors and patients – simply does not obtain in the modern era.

So, unable to side with either party, DrRich observes with great interest the debate between those who want to change the guidelines, and those who believe that changing the guidelines would be the greatest of travesties.

Those who want to change the guidelines have, in their favor, the virtue of consistency. For, if one insists that every action by physicians must be supported by evidence-based medicine, then one is pretty much obligated to fully embrace legitimate clinical trials like this one that give clear-cut and statistically significant results. Unfortunately, the evidence-based strict-constructionists have painted themselves into a corner when it comes to JUPITER. They will not be able to say, for instance, “Statins are pretty much alike, so we’ll make the guidelines say ‘statins’ instead of ‘Crestor.’” For JUPITER did not study “statins,” it studied only Crestor, the most expensive statin on the planet. Expanding the results to all statins (despite a large body of experience that suggests this would be just fine) does violence to the whole concept of evidence-based medicine. It’s just not possible. The strict constructionists have therefore boxed themselves in to advocating a new, multi-billion dollar annual expenditure.

It is even more amusing to observe those who do not want to change the guidelines.

These people fall into two general camps. First, and easier to dismiss, are those who believe that drug companies are the embodiment of evil, and that any clinical trial sponsored by a drug company must be dismissed out of hand, particularly if the drugs which are being promoted are statins. (This, in fact, is the level of argument on which the main article in the recent issue of Archives relies.)

DrRich simply notes, once again, that the advancement of clinically useful medical science – in America and in the world – is almost entirely dependent on drug companies and other corporate dens of iniquity. That companies must pay for our medical research is the system we’ve invented. Furthermore, our total capitulation to the dictates of evidence-based medicine means that companies must fund large, expensive clinical trials like JUPITER before they are allowed to sell a new product, or to create a new indication for an old product. This evidence-based paradigm is inherently a double-edged sword. Sure, it creates a huge barrier to the development and adoption of expensive new therapies (which is the covert rationing dividend of evidence-based medicine), but it also creates opportunities, for companies who manage to successfully complete such trials, to create iron-clad indications for their products. For, once a product has been “proven” in a randomized clinical trial, there is no easy way to legitimately keep that product out of the guidelines and off the shelves. The makers of Crestor have simply figured out the rules. One can whip up anti-corporate emotions by criticizing the sponsor for playing the game well, but the fact that the sponsor stands to gain does not negate in any way the results of a well-designed study.

That the anti-pharmaceutical and anti-statin crowds vociferously object to the results of the JUPITER trial is, of course, entirely expected and cheerfully acknowledged. DrRich will merely observe that their position is one of default. It is not dependent on the scientific merit of JUPITER (or any company-sponsored study), and thus it adds no useful information to the debate. We can only note their objections and move on.

The second group of people who object to changing the guidelines are less dogmatic and more open to reason, and indeed (and very interestingly so) claim to be proponents of evidence-based medicine, and thus claim to be willing to follow the data to where it will lead. It seems pretty clear (to DrRich, anyway), that the chief concern of these individuals, as it relates to JUPITER, is cost. That is, this group feels strongly that the implications of the JUPITER trial are simply too costly to follow to their logical conclusion. This, indeed, is a very reasonable position to take.

Unfortunately, the only legitimate way to turn aside the results of a costly but statistically definitive, evidence-based study is by rationing healthcare. (To ration, remember, is to withhold at least some useful medical services from at least some people who would be likely to benefit from those services.) But we can’t do that, because, well, it would be rationing. Because members of this second group are unable to invoke the “r” word, they are therefore forced to find other “reasons” for keeping the guidelines unchanged. This unfortunate situation leaves them little choice but to discover ways in which to impugn the legitimacy of the JUPITER trial.

In short, they find themselves forced to engage in statistical legerdemain in order to diminish the significance of the JUPITER trial. There are several useful statistical arguments they can employ.

From what DrRich has seen, many of the arguments that have been ginned up to this end have not come directly from the JUPITER trial itself, but instead from an editorial accompanying this study, written by Dr. Mark A. Hlatky.

Most of Dr. Hlatky’s editorial is measured and reasonable. But he threw in a key summary sentence that has been greedily grasped by the anti-alter-guidelinetarians, to wit: “The proportion of participants with hard cardiac events in JUPITER was reduced from 1.8% (157 of 8901 subjects) in the placebo group to 0.9% (83 of the 8901 subjects) in the rosuvastatin [Crestor] group; thus, 120 participants were treated for 1.9 years to prevent one event.”

This statement, at least taken at its face value as a stand-alone analysis, is statistically naive and wrong. DrRich realizes that one or two of his readers might not enjoy statistical arguments, so if you do not wish to wade through the reasons why, simply skip the next two indented paragraphs.

In a long-term clinical study in which the endpoints are events that can occur at any time (such as heart attack, stroke or death), then the probability that an enrolled patient will reach an endpoint in the trial increases the longer he/she has been enrolled in the trial. But in virtually all clinical trials, the length of time different people are enrolled varies greatly. This is because it often takes years to enroll people in clinical trials, so that when the trial ends, some will have been in the trial for many years, others for only a little while. This means that the risk exposure of each research subject is different, and is proportional to the total time they were enrolled. Not uncommonly, the enrollment process is not smooth – there are periods of more rapid enrollment, and periods of slower enrollment – so if all you do is average the enrollment time (as was done by Hlatky – 1.9 years) you are likely to get skewed results. So it is simply not statistically legitimate to do so.

There is a legitimate way of analyzing such longitudinal outcome statistics, and it’s called the Kaplan-Meier method. And indeed, the authors of the JUPITER trial presented in their paper a complete Kaplan-Meier analysis of their data (see Figure 1 of their paper), and the results look quite a bit different from Hlatky’s summary statement. The Kaplan-Meier analysis reveals that the risk of heart attack, stroke, and death all increase steadily through at least 4 years (5 years was the longest time anyone was enrolled in this study), so that at 4 years, the risk of reaching one of the “cardiovascular event” endpoints was about 8% (not 1.8%). Further, the Kaplan-Meier analysis shows that the protection imparted by Crestor persists through at least 4 years, and that indeed the magnitude of protection (i.e., the difference in outcomes between the treated group and the placebo group) increases throughout that entire duration. So, at 4 years, the placebo group had roughly an 8% event rate, compared to roughly a 3% event rate for the Crestor group – an absolute difference of about 5% (not 0.9%). This is a far greater benefit than is suggested by Hlatky’s shorthand summary.

Suffice to say, then, that Hlatky’s summary statement apparently ignores the appropriately analyzed data which is clearly presented in the JUPITER paper itself, and which documents that the clinical benefit of Crestor was substantially more impressive than his widely-quoted summary statement suggests.

But as illegitimate as this summary statement may be, let us accept it at face value for a moment just for the sake of discussion, since that’s the data the anti-alter-guidelinetarians have latched on to.

Taking these numbers, the “antis” make the following argument: While the relative reduction in “hard cardiac events” is 50% (1.8 to 0.9), the absolute reduction is only 0.9%, which, anyone would agree, is a pretty small number. So, they conclude, the actual benefit imparted by Crestor is actually quite small.

That’s a very interesting argument. Let’s look at it in a couple of ways.

So we’ve got a population of patients whose risk of heart attack, stroke, bypass surgery/stenting, or death is about 2% at about 2 years, and by giving them a pill we can reduce that risk to about 1%, and we’re arguing that the absolute drop of 1% is not very much to crow about. Well, OK. But what if we found a pill that reduced their risk to zero at 2 years? That is, it completely wiped out the risk of cardiovascular catastrophes altogether. Would that be a good thing? Or would we say, “It’s just a 2% drop, really not much greater than the 1% drop we had with Crestor, so it’s no big deal?” DrRich thinks not. DrRich supposes we would think that totally eliminating all cardiovascular risk would be a very big deal.

When you’re starting at a 2% risk, then any drop in risk is going to be an “absolutely” small number. And if we’re not going to pursue improvements in outcome of such a small magnitude, then why the heck are we worrying about preventative medicine in the first place? Once you get past the big things (drain the swamps, don’t drink the water downhill from the outhouse, etc.) then all preventative medicine tends to consist of small, incremental improvements in outcome. Popular pronouncements to the contrary notwithstanding, preventative medicine is largely the art of spending a lot of money for this kind of incremental improvement. If we decide we shouldn’t do this anymore, then DrRich would find it unfortunate but understandable. But it hardly seems reasonable to arbitrarily focus on this one, particular improvement in preventative cardiology, and (within a healthcare system that insists it is not rationing care) pronounce that this is the one we’re not paying for.

Another way of looking at this “the benefit is too small” argument is by considering that 7.4 million Americans fit the entrance criteria for JUPITER. By giving all these people a statin, we would be preventing about 66,600 major cardiovascular events over a 2 year period. If you’re going to say that 1% is a small number, DrRich will counter that 66,600 is a big number. So do statins offer a substantial benefit or not? It depends on whether you choose to focus arbitrarily on the 1% or the 66,600.

(DrRich understands that many of his readers are not focusing at this moment on the 66,600 cardiovascular catastrophes that could be prevented, but on the 7.4 million people who will be taking a drug that costs $120 per month. But we’re not talking about cost yet, we’re only talking about whether the drug does some good. If we decide it does, then we’ll need to link that “good” to a procedure that measures whether the “good” is worth the money we would need to spend to achieve it. The “antis” try to avoid talking about cost – since that would admit they’re rationing – by insisting that there’s just not enough “good” to bother with. DrRich is simply pointing out that such an argument – that preventing 66,600 very bad outcomes is not enough to bother with – is on its face absurd.)

Another argument invoked by the anti-alter-guidelinetarians is based on the “number needed to treat” (NNT) analysis. Again they rely on Hlatky’s unfortunate summary of the data: “120 participants were treated for 1.9 years to prevent one event.” This number – which the “antis” insist is just too high – is misleading for the reasons already discussed. The real NNT, based on more legitimate statistical analysis, is plainly laid out in the JUPITER paper itself. It turns out that the longer patients in this trial were treated with Crestor, the lower the NNT became. So: At 2 years, the NNT was 95; at 4 years, it was 31; and at 5 years, it was projected to be only 25. Whether you think it is reasonable to treat 25 people with a pill for 5 years to prevent one of them from having a heart attack, stroke, or death is, DrRich supposes, a matter of opinion. But based on NNT analyses for many widely-accepted therapies in medicine today, it looks pretty good.

All these arguments, of course, are merely distractions. The fact is that JUPITER showed a pretty striking reduction in nasty cardiovascular events over s pretty brief period of time, and the only real reason there’s any controversy at all is because of the cost of Crestor.

That cost is what makes us want to withhold Crestor, even though it is imparting at least some (and, DrRich, argues, quite a bit of) clinical benefit. In other words, the high cost makes us want to ration Crestor. The fact that we can only ration covertly, instead of openly, is what makes us want to bastardize the science and do a Kabuki dance with the statistics.

If we were rationing healthcare openly, then we could do an objective, full-bore cost-benefit analysis on the use of Crestor in JUPITER patients, using legitimate and not ginned-up statistical analysis, and taking into account not only the cost of the drug, but also the cost that would be incurred by failing to stop preventable heart attacks, strokes, etc., and then determining where the overall cost-benefit result fell within our coverage criteria. If it met the criteria we would cover it, if not, not. This decision would not be arbitrary. It would be a fully transparent process, so that if the sponsor did not like the results, they would try diligently to find a way to reduce the cost of Crestor (DrRich thinks they would succeed) to a value that would be compatible with their staying in business. (And for the first time, the price of medical products would be determined by a Laffer-like curve, where a price that was too high – like taxes that are too high – would reduce revenue, instead of increase revenue. Companies, being fairly rational, would ratchet their prices down to the optimal price point.)

But since we insist on doing our rationing covertly, DrRich is sorry to say that we’re destined to keep making spurious arguments, and using dumbed-down statistical analysis to back them up. The JUPITER trial, while it is imperfect and while it does not answer every question, really is pretty straightforward. That we get so wrapped around the axle trying to fold such clinical trials into our covert rationing paradigm is simply another demonstration of the fact that covert rationing corrupts everything it touches.

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Now, read the whole story.

DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.

Now on Kindle!

(A Heartfelt Plea To Certain Authors Of The Health Care Renewal Blog)

Podcast:

The other day, President Obama gave a commencement speech in which he pointed out one of the downsides of living in a new age of electronic communication:

“Meanwhile, you’re coming of age in a 24/7 media environment that bombards us with all kinds of content and exposes us to all kinds of arguments, some of which don’t rank all that high on the truth meter. . . .[I]nformation becomes a distraction, a diversion, a form of entertainment, rather than a tool of empowerment. All of this is not only putting new pressures on you; it is putting new pressures on our country and on our democracy.”

In other words, too much information can be bad (since it can be untruthful, and places pressure on our country and democracy). Clearly implied in this statement is the idea that something ought to be done about all that extraneous information out there. Presumably, disinterested truth-tellers in our unbiased government bureaucracies ought to sort out fact from fiction, and take the necessary steps to get rid of the fiction. This is not the first time the White House has offered to monitor the utterings of wrong-thinking Americans, and to do what is needed to correct their misapprehensions. Rather, it is simply another reinforcement of a consistent theme under our current administration.

We had best take it seriously.

And so, it is with some reluctance that DrRich finds it necessary at this time to perform an intervention. He does so with the kindest of motives, namely, to protect two people he greatly admires from finding themselves on the wrong side of a Federal disinformation bust.

DrRich speaks, of course, of Dr. Roy Poses and his colleague MedInformaticsMD (who had best not rely on an easily-decoded pseudonym for protection), two of the principle authors of the excellent Health Care Renewal blog. Both of these highly respected physicians and bloggers have posted articles this week which are critical of individuals who have spoken out against obese Americans.

Dr. Poses started it, pointing out that certain high-profile executives who have made recent public statements decrying obesity, and ridiculing (and offering to discriminate against) the obese, are pontificating on an issue about which they have no professional expertise.

MedInformaticsMD upped the ante by referring to these same executives as obesity bigots, and pointing out (rather colorfully) that such a person “talks stupidly and discriminatorily out of his anal orifice about how much people put in the other end of their GI tracts.”

Now, DrRich does not know how likely it is that Federal truth-tellers will stumble across these offensive posts. Given the stuff DrRich himself has said about healthcare reform and our government, he hopes it is unlikely indeed.

But Gentlemen of the HCR blog! Whereas DrRich habitually employs enough irony in his writings that most stone-witted bureaucrats (he hopes!) will have trouble discerning what he actually thinks, your prose is uncomfortably straightforward, and leaves no room for interpretation. If they find it, you are screwed.

And so, DrRich begs you to allow him an opportunity to set you straight on American obesity, and the importance of the anti-obesity movement.

To understand this, one must understand the underlying premise: Under any soup-to-nuts universal healthcare system (which, DrRich submits, is the ultimate goal), our central authorities, in the name of controlling costs, have got to be able to restrict, control and tax virtually any human behavior they can claim may lead to an increased risk of healthcare expenditures – which, really, encompasses virtually any human behavior you can think of.

Such power on the part of our central authorities will feel “unnatural” to many if not most Americans, if not developed judiciously. And so, it makes sense to develop such power – to set precedents which, once set, will be impossible to stop – by demonizing the obese, and making it not only OK, but imperative, for the government to control their unutterably selfish behavior, and, failing that, to punish them.

It is not difficult to demonize the obese. In literature and films the obese have long been portrayed as unreasonably jolly, slovenly and lazy, or just plain evil. (Hello, Newman!) Nobody likes to sit next to them on airplanes or buses. They block the aisles at the grocery store (their favorite haunts), and they reduce miles-per-gallon (and cause excessive tire wear) when they ride in our cars. On humid days, they sweat (and thus smell) more than you and I. So, with rare exceptions (and it is unfortunate that you two Gentlemen comprise one of these), nobody complains when the obese are criticized and attacked.

Given the current hypersensitivity to anything smacking of criticism of various races, ethnic groups, professions, political movements, sexual orientations, immigration status, victims of certain diseases, and scores of other categories of Americans, the obese present us with a refreshingly – and indeed the only – safe target. As the authors of the HCR blog point out, prominent and respected figures feel no compunction whatsoever against making the most offensive public statements against the obese, and when they do they receive (with rare exceptions such as provided by you HRC Gentlemen) applause rather than condemnation.

Obesity is a condition which is immediately visible to all – and from a great distance – and which immediately labels one as being selfish and lazy, and, now, as entirely unconcerned that their bad behavior is costing the rest of us our healthcare dollars, and thus, potentially our lives. Hating the obese has become nearly a patriotic imperative.

Fully government-funded and government-controlled healthcare (by whatever subterfuge we finally get there) permits – nay, demands! – that we declare to the obese that their unsightly physiques are no longer a matter of personal choice, but are now a matter of legitimate public concern. The choices they are making – that is, their gluttony, sloth and all other manner of self-indulgence – are placing unwanted and unsustainable demands on us purer, svelter, fellow-citizens, not to mention placing us in danger of not receiving the healthcare which we (in contrast) actually deserve.

It is already far too late, Gentlemen, to appeal to mere reasonableness, rationality, or, especially civility.  We are well past that stage. Observe: It has become acceptable to write, and accept for publication, “scientific” papers claiming that the obese are the chief cause of global warming. Observe again: It has become acceptable to write, and accept for publication, “scientific” papers claiming that obesity is contagious, and that – never mind associating with the obese themselves – it is risky associating with the very friends of the obese. (That is, even those who like, or tolerate, fat people are to be shunned.)

By their own selfish actions, actions which threaten the collective far more than merely themselves, the obese have become fair game for whatever manipulations our government can devise to cause them to either lose weight, or pay for their sins. Such maneuvers may begin with simple taxes on foodstuffs favored by the obese, but the sky’s the limit. A special “carbon tax” based on their BMI would be legitimate, for instance, since it will always cost a lot of energy to move a fat person from point A to point B, whatever the mode of transportation. The periodic mandatory public “weigh-ins” such a tax would justify would serve the useful purpose of public humiliation, an important incentive to weight loss. And it goes without saying that the ultimate censure – already employed in more enlightened cultures such as Great Britain – would be simply to withhold certain healthcare services if one is deemed too fat.

Demonizing the obese provides several important precedents to our central authorities. That it sets an important precedent – and establishes the mechanisms and techniques – for controlling the private behaviors of American citizens is obvious. But it also allows us to place the blame for a medical condition, which largely depends on genetic predisposition, solely on the chosen behavior of its victims. Discriminating against those who have genetically-mediated conditions thus becomes possible.

Discriminating against obesity also sets a precedent for discriminating against the lower economic classes (since obesity, rather than starvation, is the chief nutritional problem of the poor in America). This will prove a useful tool when we set future behavioral standards to reduce healthcare spending, since so much of that spending is for the economically disadvantaged.

And so, Gentlemen of the HRC blog, it ought to be painfully clear that successfully demonizing the obese is a vital pillar of our new healthcare system. And when you express the unfortunate ideas the two of you have published this week (namely, that discrimination against the obese is somehow unhelpful), you are placing a large target on yourselves, and on your otherwise excellent blog. (And by extension, you may be placing more innocent blogs, like this one,  under more official scrutiny than might be comfortable.)

DrRich sincerely hopes you will take these comments in the communal spirit in which they are intended.

Podcast:

People who do not like the new healthcare system our government is establishing for us intend to formally challenge the constitutionality of one of its major provisions, namely, the “individual mandate” – the provision that all individuals must purchase health insurance.

The grounds for challenging the individual mandate, essentially, is that the Constitution does not grant the federal government the authority to compel legal residents of the U.S. to purchase a particular product, or enter into a particular contract, simply as a matter of their being legal residents. For many of those who object to the new healthcare law, the individual mandate goes to the principle reason for their objections – that the government has assumed for itself sweeping new powers that directly impinge on the liberty of individuals.

DrRich himself feels this way. If the government can make us buy a product against our will for the sake of the common good, then a firewall will have been taken down, and DrRich does not see any fundamental barrier to the government being allowed to compel us to any action it deems to be for the common good.

For instance, since your obesity, by sucking up limited healthcare resources, will impinge on DrRich’s ability to get whatever healthcare services he thinks he might desire, DrRich can now legitimately petition the government to regulate your intake of Twinkies. You fatty. And as for all you overweight middle-aged women out there, who habitually fail to perform the hour-per-day of exercise that best medical evidence insists you perform, it would be entirely appropriate for the President’s proposed army of college-age zealots – the Civilian Service Corps or whatever he’s going to call it – to show up every day to organize you and your similarly-shaped neighbors into ranks, for hour-long forced marches.

You may think DrRich exaggerates. DrRich hopes so, too. But he’s not sure.

In any case, for those among his readers who do not want any constitutional challenge of the new healthcare law to succeed, DrRich has good news. It won’t.

DrRich has come to this conclusion after reading the section of the law that deals with the individual mandate. This section, “Subtitle F – Shared Responsibility For Health Care,” is carefully designed to defeat any constitutional challenge.

The meat of Subtitle F is contained in one sentence (Section 5000A), to wit: “An applicable individual shall for each month beginning after 2013 ensure that the individual, and any dependent of the individual who is an applicable individual, is covered under minimum essential coverage for such month.” This sentence takes up about 20% of one page. Most of the remaining 42.8 pages of Subtitle F creates a protective shell against constitutional challenge. It does this in two ways.

The first protection against a constitutional challenge is the more obvious. In fact, before we ever get to the individual mandate itself, we are treated to five pages that detail the multitude of ways in which “individual responsibility” in healthcare (i.e., the mandate to buy insurance) “is commercial and economic in nature, and substantially affects interstate commerce, as a result of the effects described in paragraph (2).” In other words, the individual mandate is wrapped by a formal “finding of Congress” that this mandate is subject to the Commerce Clause of the U.S. Constitution.

DrRich is not enough of a legal scholar to understand whether the five pages of justification that follow (the “paragraph 2,” referred to above) are sufficiently compelling to actually invoke the Commerce Clause. To him, it all sounds like an “ends justifies the means” argument, one that would be equally applicable if Congress decided it would benefit the general welfare to mandate that people purchase all their cars from Government Motors. But whether or not the supportive language itself proves compelling to the courts, it seems very unlikely to DrRich that the Supreme Court would overturn a formal “finding of Congress,” as regards the applicability of a provision of Congress to the Commerce Clause.

But this first protection against a constitutional challenge only covers the first five of the 43 pages of Subtitle F. Most of the remaining 38 pages establishes the second protection. This one is more subtle than the first, but, DrRich thinks, it will be the more difficult one to overcome.

That remaining portion of Subtitle F deals largely with the penalties to which individuals would be subject if they failed to comply with the mandate to buy health insurance. It describes in detail how the mandate is to be complied with, how compliance is to be documented, and how the mandate is to be enforced. This long section of Subtitle F reads like tax law, like IRS code. As well it should. For, what it establishes is that the individual mandate is actually a tax, that is treated like any other tax in its documentation, collection, and enforcement, and indeed, that the IRS will be running the whole show.

If DrRich were defending the individual mandate before the Supreme Court, here is what he would say.

“Your Honors (and you other Justices, too), even if you find that the Commerce Clause is not applicable here (a finding, I respectfully submit, which would create a Constitutional crisis, since Congress has issued its own formal finding to the contrary), you must let this provision stand for an even more compelling reason, which is: This is not really an individual mandate to purchase health insurance or any other product, as our opponents claim. It is, in fact, simply a tax, like any other tax.

It is a tax. A healthcare tax. It is a tax to support healthcare in the United States, payable to the U.S. Government on Form 1040, administered and collected entirely by the Internal Revenue Service. It is not in any way fundamentally different from the Medicare and Medicaid taxes, which also support healthcare services for our citizens, which also appear on Form 1040, and which are also administered and collected entirely by the IRS.

Your Honors, simply look at the language of Subtitle F. After a modest amount of palaver to convince Your Honors that the Commerce Clause applies (and, I remind you, it does), the last 38 pages of this Subtitle is tax law. I mean, really, just try to read it. Can any of you understand it? Neither can I. It’s IRS tax code, plain and simple.

The only difference between this tax and any other federal tax is that Congress, in its wisdom and magnanimity, gives the individual citizen the ability to opt out, to not have to pay it, simply by documenting that they have purchased health insurance. That is, if the citizen chooses to buy health insurance – which, we must all admit, would be a wise decision from that individual’s point of view, as well as a benefit to society – the IRS will forgive the new healthcare tax altogether.

Where is the mandate here? Nowhere in Subtitle F does the word “mandate” appear. Rather, Subtitle F refers to “shared responsibility.” Individuals should feel responsible to do their part for society as a whole, and this Subtitle encourages them to act on that responsibility. They can do so by paying the new healthcare tax. Or, if they choose, they can do so by making sure they and their families are covered by health insurance. To be sure, Congress’ intent was that the large majority of citizens would choose the latter. But for all that, it is in the end the individual’s choice.”

As much as DrRich wishes otherwise, the individual mandate in the new healthcare law has been written in such a way as to almost certainly turn aside any challenges based on its constitutionality.

So, ladies, form your ranks and start marching that fat off. Hep-two-three-four.