Why Big Health Insurance Supported Obamacare, Part II
The fact that the health insurance industry supported Obamacare from the very beginning was entirely missed by the mainstream press. This is perhaps understandable, since a) the mainstream press does not understand the dynamics of the healthcare system, and b) during the Obamacare drama, the health insurance companies had been assigned, and had graciously accepted, their vital role as the Forces of Evil. To the famously credulous members of the mainstream press, it was easy to imagine that the insurers were actually among the opposition.
But the insurance industry supported Obamacare from the start – and even before the start. During the Presidential race of 2008, for instance, managed care companies donated far more money to both Barack Obama and Hillary Clinton than to any Republican candidate, even though both of these Democratic candidates publicly castigated the insurance companies for producing most of the problems in American healthcare, and promised to institute reforms that would drastically cramp their style and reduce their profits.
Why would the insurance industry support the very candidates whose chief healthcare strategy was to demonize them? Quite simply, it was because the insurance industry had nowhere else to go.
By the time Mr. Obama became president, the once proud, self-confident, and even arrogant American health insurance industry had been completely humbled. Like the old Soviet Union twenty years earlier, it still may have looked formidable from the outside, but it was really an empty shell. The industry had run out its string; it was entirely bereft of ideas. Its business model was completely broken, and it desperately needed an exit strategy. And it was due to the need to find a serviceable exit strategy that the industry supported Obamacare.
To understand what landed the insurance industry in this sad state of affairs, it is necessary to review its recent history.
The Rise of the For-Profit HMOs
When the Clintons set out to reform the American healthcare system in 1993, the health insurance industry initially claimed to support them. The Clintons had promised them a vast new market – the millions of heretofore uninsured Americans whose premiums would be paid, presumably, by the government.
But the alliance fell apart the moment the insurance industry began reading the massive tome of regulations the Clintons finally produced, and found in it much they didn’t like. Chiefly, they they didn’t like the parts that ceded full control of their industry to the government. So Big Health Insurance immediately turned against the Clintons, and spent millions of dollars introducing us to Harry and Louise (a “typical” American husband and wife who were viewed in numerous TV commercials discovering various appalling provisions of the Clinton plan). In the end, when the Clinton’s reform plan went down to ignominious defeat, the powerful health insurance industry, appropriately, got most of the credit.
Most of us Americans were happy at the time that the Clintons’ plan had been defeated, but during the debate over healthcare reform we had become convinced that the old way of doing healthcare wasn’t any good either. The healthcare system, we all knew by now, was bankrupting us. And something needed to be done about it. But with the Clinton plan off the table, what were our options?
In the ashes of the Clintons’ failed effort, the health insurers saw their golden opportunity. And they presented the American people with a savior. The savior was, of course, them.
The insurance industry made its pitch in a new guise which we Americans had never seen before. For the big fee-for-service insurance companies had transformed themselves into HMOs, and had fully assimilated the language of managed care. These were not the touchy-feely, non-profit HMOs that had been puttering around in the healthcare system for a decade or so. These were meat-and-potatoes, for-profit HMOs, run for the most part by hard-nosed business executives, and newly formulated for a new era of American healthcare.
And here is what they said: “Citizens! We all – employers, patients, physicians, hospitals, manufacturers and insurers – have just dodged a bullet. Thanks to us, the frightening socialist reforms of the Clintons have been soundly defeated. But where does this leave us? We stand now between Scylla and Charybdis, between the specter of nationalized healthcare on one hand, and the continued profligacy of traditional fee-for-service medicine on the other. And we cannot countenance either. But here,” they continued, “is a third way. A painless way, based on the sound principles of managed care, open markets, and free enterprise. Let healthcare become a business like any other business, and the market forces will find ways not only to cut costs but also to improve quality, and with no government intervention.”
The offer, in other words, was to turn healthcare over to the business professionals now running the New Model HMOs, who were cocky with the certainty that they could harness the efficiencies of the marketplace to control costs, make a big profit at the same time, and be feted as saviors to boot. Because we’re Americans and we know the benefits of capitalism, and because the other choices we faced looked even worse, we all said, “Go for it.”
This change led to the most rapid transformation the American healthcare system has ever seen, and within a few short years, the majority of Americans were enrolled in HMOs, or some other species of corporate managed care.
So HMO executives set out to control the cost of American healthcare, and to make a spectacular profit doing it. And for a few years, they seemed successful. Healthcare inflation slowed dramatically in the late 1990s, and HMO profits soared.
But it was all an illusion.
The Fall of the For-Profit HMOs
The initial impressive profitability of New Model HMOs was due to the one-time reduction in cost you always get when you implement efficiencies of scale (made possible by merging enterprises), and by instituting the new standardization techniques favored by managed care theory. These steps reduced the cost of healthcare for a while, but the underlying rate of healthcare inflation (which is mostly caused by new medical technologies and an aging population, neither of which are cured by managed care) was pretty much unchanged. So by the early 2000s, when these one-time cost reductions had been fully realized, healthcare inflation was right back on the same unsustainable trajectory it had been on before.
Unfortunately for the HMOs, the big profits they enjoyed throughout the 1990s could not last. Their rapidly expanding valuations were attributable not to their efficient management of healthcare, but instead, to the frenzy of mergers that rapidly ensued, and to the acquisition and privatization of not-for-profit public assets for a tiny fraction of their true value.
So not long after the turn of the century the for-profit managed care companies were getting very nervous. For the very first time in their history, HMOs were faced with the prospect of having to earn their profits, profits sufficient to satisfy their shareholders, by actually managing the healthcare of sick people. This is something they had never accomplished before, and, by the time the election of 2008 approached, they knew they never would.
By that time they had tried everything. Beginning in 1994, filled with confidence and enthusiasm and cheered on (initially, at least) by the public and by public officials alike, the health insurance companies had more than 15 years of more-or-less unfettered freedom to institute any efficiencies they wanted to. In the ensuing years insurance companies tried all kinds of legitimate ideas for reducing healthcare costs, such as managed care, gatekeepers, clinical pathways, disease management programs, pay for performance, wellness programs, medical homes, and even a ruthless consolidation of the industry to achieve “efficiencies of scale.”
They also tried every sneaky and underhanded idea they could think of for reducing costs, like cherry-picking the healthy patients, treating chronically ill patients like pariahs so they would go away, making access to specialty care as inconvenient as possible, forcing doctors to sign “gag clauses” to prevent them from telling their patients about certain treatment options, browbeating primary care physicians into zombie-like compliance with handed-down care directives, refusing to cover expensive-but-effective medical services, and canceling the policies of tens of thousands of patients after they get sick, based on trumped-up technicalities. Indeed, they tried everything short of dispatching teams of Ninjas in the dark of night to slaughter their most expensive subscribers in their beds. And finally, when all else failed, they instituted huge and unsustainable annual increases in premiums, to the point of driving their customers out of the market. (This latter move, of course, was an open acknowledgment that the industry had entered its death spiral.)
All these efforts were to little avail. The cost of healthcare continued to skyrocket, entirely unabated. And by 2009, when President Obama began his push for healthcare reform, the insurance companies knew they had no prospect of long-term profitability. Their business model was no longer viable, and, while telling soothing stories to avoid shareholder panic, they were urgently casting about for an exit strategy.
A drowning man will cling to any piece of flotsam that comes his way. What the insurance industry found floating by was Obamacare.
What Health Insurers Get From Obamacare
In return for its support in the healthcare reform battle, President Obama offered the insurance industry the graceful exit strategy it so desperately needed. Under Obamacare, for at least a few years the insurers hope to get One Last Windfall – namely, profits from the influx of previously-uninsured Americans whose premiums will be paid, or at least subsidized, by taxpayers. Here, the insurers are relying on the likelihood that the inflow of new premiums will, for a year or two at least, greatly outweigh the outflow of money they will have to spend caring for these new subscribers. Obviously, they will use every trick in their well-worn book to stave off expenditures for these new subscribers for as long as they can, but if they actually knew how to avoid paying healthcare costs indefinitely, they wouldn’t be seeking a government bail-out today. In any case, an inflow of new subscribers will be a very temporary source of profit for insurers. Hence, at best it is One Last Windfall.
What happens to the insurers after they exhaust this last windfall is still up in the air. Obamacare may, of course, eventually transition to a single-payer system, an outcome which many conservatives desperately fear, and many liberals fervently desire. In this case, there may very well be some final compensatory buy-out (or a buy-off) for the insurance companies. But more likely, the insurance companies under Obamacare will continue to exist essentially as public utilities. That is, they will exist as companies chartered by the government, which administer healthcare under the direction of the government, with the products they may offer, the prices they may charge, the profits they may keep, and the losses they may incur, determined solely by the government. It’s not glorious, but it’s a living.
And it’s much better than where they would have ended up without Obamacare. Which is why they supported it from the start.
Now that we know why the insurance industry supported Obamacare, in the next post we will explore how the industry, at no small cost to its own public image, supported the President when it counted most.
Why Big Health Insurance Supported Obamacare
DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.
Why Big Health Insurance Supported Obamacare, Part I
When President Obama moved into the White House in January of 2009, he found in the Oval Office a bust of Sir Winston Churchill, a gift from Great Britain to the United States during the Reagan presidency, a gift meant to symbolize the close ties between our two nations. The new President quickly decided he did not want to look at it. And, as one of the first acts of his presidency (before advancing his Stimulus Package, or pushing healthcare reform, or even inviting Andy Stern to dinner), he had that bust placed into a crate, packed with sawdust, and shipped by the afternoon mail right back to England.
DrRich can think of several reasons why it might have been a better idea, instead of beginning his reign with a completely gratuitous insult to America’s longest and best and most-needed ally, for President Obama to quietly have had the bust moved to the White House basement, where Sir Winston could have spent the next four to eight years contemplating all those other now-obsolete or embarrassing diplomatic trinkets, such as the gold plate from the Shah of Iran, and the fine old portrait of Ferdinand and Imelda Marcos.
And here’s one of them.
Despite the fact that President Obama was elected by a wide margin, and that he brought with him a filibuster-proof majority in the Senate and a large majority in the House, and that he had loyal, powerful and dogged leaders in each chamber of Congress who completely supported his agenda, and that the major American media was largely behind him all the way, the passage of the Obamacare legislation was very hard-fought, and a very close thing. Its ultimate passage was a major victory for the President, and a great tribute to his persistence. In fact, DrRich believes that President Obama has not received nearly enough credit for the utter doggedness and persistence he displayed in the face of the terrible headwinds he sometimes encountered while passing his healthcare reform agenda.
Indeed, during this arduous process, he was almost Churchillian in his steadfastness.
So, had he kept it, President Obama might now gaze upon bust of Churchill and see not the man who had campaigned against people of color in order to keep the British Empire together, but rather, a man who, not unlike himself, had almost single-handedly saved western civilization from the forces of evil.
But there is another striking similarity between these two men, aside from the remarkable singlemindedness they displayed under pressure, which is: neither of them could have succeeded alone. Their iron will, their persistence, their personal courage, and their (too often weak-kneed) support from political allies would not have carried the day, had it not been for the assistance of a powerful, if silent, partner.
In 1940-41, when Winston Churchill stood virtually alone against the Nazi onslaught, and with dwindling resources and a badly beaten military tried to face down a powerful enemy, he utterly relied on the support – often tacit, rarely public, only occasionally material, but always firm and unwavering – of Franklin Roosevelt. And no matter how bleak things looked, Churchill always believed that, one way or another, in the end President Roosevelt and the great might of the United States would provide a way to final victory.
Similarly, when the President’s initially smooth path to healthcare reform was suddenly interrupted by a blitzkrieg of contentious town hall meetings, followed closely by the formation of the vociferously anti-Obamacare Tea Party movement, followed next by the surprising victory of Chris Christie for the governorship of New Jersey, and capped by the stunning ascension of Scott Brown to the Senate seat long held by Ted Kennedy, an event that appeared to leave the prospects for healthcare reform so bleak that a week later the issue was barely raised in the State of the Union address, and that caused even the sympathetic press and some of his fellow Democrats to declare the prospects for healthcare reform to be dead, President Obama had to reach deep within himself to find the resolve for one last push. And in that dark moment he, too, was able to draw courage from the tacit, rarely public, only occasionally material, but strong and unwavering support of his own silent partner.
That silent partner, of course, was the American health insurance industry.
And as was the case with Sir Winston, in the moment of greatest crisis President Obama’s own silent partner threw itself into the fight with great abandon, and ultimately enabled a final victory.
Why the health insurance industry supported Obamacare, and how it did so, should be of more than mere casual interest to Americans. It has major implications for anyone who favors repealing Obamacare or major parts of it, or de-funding it, or declaring it unconstitutional. Anyone who is approaching the 2010 mid-term elections thinking that we can just get rid of Obamacare and go back to the way things were – or even to a substantial modification of the way things were – had better understand what just happened.
So in his next few posts, DrRich will examine the role that the American health insurance industry played in the passage of Obamacare, and what the recent behavior of that industry implies as we decide what we should – and can – do next.
Why Big Health Insurance Supported Obamacare
DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.
When DrRich was a little tyke, he always loved it when Uncle Harry came to visit. Uncle Harry was a large, rotund man with a ready smile and a jolly laugh, who was genuinely delighted to spend hours entertaining little DrRich and all the other children with his jokes, stories, magic tricks, and samples from the large stash of candies he always kept in his coat pockets. We all loved Uncle Harry.
But we were deceived.
Little did DrRich know, in his youthful innocence, that far from being the cheerful and beloved amateur prestidigitator delighting us with his his egg trick, Uncle Harry was actually a menace. For Uncle Harry was obese.
We now know, of course, that obese people, through their gluttony, sloth and lack of self-control, are causing untold harm to our society. They are unpleasant to sit next to on buses and airplanes. They use more than their rightful share of healthcare resources. They snore. They cause excessive tire wear (and if they sit in the same seat all the time, the tire wear will be asymmetrical, probably leading to an increase in automobile accidents).
And now, thanks to a recently published academic article, we know that the obese are largely responsible for global warming.
That global warming is taking place, and that it is being produced by mankind, of course, is a settled issue. DrRich is led to understand that a great council of hand-picked environmental scientists, taking a lesson from the Council of Nicaea, has met and has decreed it to be so. The entire body of scientific evidence has been formally considered, and like the Holy Scripture has been carefully locked down into its final form, and has been divided into orthodoxy (the study of which is holy) and heresy (the study of which leads to perdition). And having accomplished this task, the scientific community will hereafter countenance no dissension on the matter, and will admit no further debate or even any further data (unless it is corroborative data). For this is how science is supposed to work, at least for matters as critically important as global warming.
DrRich calls it Environmental Scholasticism, and believes it is about time we returned to a system of thought that was good enough for some pretty important Saints. The notion that scientific viewpoints should never be considered “closed,” and should always be open to challenge as new evidence and new ideas come to light, is a relatively recent invention initiated by the likes of Galileo and Newton, and has led to nothing but trouble (such as, for instance, global warming).
In any case, now that we know once and for all that global warming is man-made, it behooves us to figure out which men (and women) are causing it. And now, according to two eminent scholars at the Department of Epidemiology and Population Health, at the London School of Hygiene & Tropical Medicine, we know that among the chief culprits are the fat. That is, fat people, through the office of their obesity itself, are responsible for a significant degree of the carbon emissions that are unarguably (and officially) destroying our planet.
This fact, heralded by radio and newspaper reports proclaiming, “Fatties Cause Global Warming,” was revealed in a “scientific” paper written by Professors Edwards and Roberts and published by the prestigious Oxford Press in the International Journal of Epidemiology.
The paper really ought to be perused directly to appreciate the elevated level of scholasticism employed by the authors, which would make even Thomas Aquinas and Albertus Magnus themselves sit up and take notice. For this paper, which indicts a whole class of individuals with the supreme crime of global warming, a crime whose disastrous effect on our planet eventually will make the atrocities perpetrated by even Hitler and Stalin seem mere trifles in comparison, reaches its conclusions without ever offering even one tiny glimmer of actual data or evidence.
Rather, the authors rely (as true scholastics must) on the approved body of scientific work, choosing from that body an array of assumptions based on bits of sanctified data from physiology here (e.g., Basal Metabolic Rate = 11.5 X body weight in KG + 873kcal), and behavioral science there (e.g., that the average daily activities of humans consists of 7 hours sleeping, 7 hours of office work, 4 hours of light home activities, 4 hours sitting, 1 hour standing, 30 min of driving and 30 min of walking at 5 km/h), then applying these bits to an incredible chain of assumptions and estimations, to demonstrate that the negative impact of the obese on our society goes far beyond what we currently think. Indeed, through such machinations it can be concluded that the obese are melting the ice caps, killing polar bears, flooding the seacoasts, and turning our farmland, forests and fields into hot, dry, desert.
Anyone with a cheap telescope can conclude from all this that Martians, when they existed, must have been really fat.
This information, of course, will come in very handy when we are forced at last to reduce our healthcare costs, and we find we need somebody to blame. We can already discriminate against smokers with a clear conscience. And now discriminating against the obese can be accomplished not only with a clear conscience, but with a sense of duty. For, far from merely costing the healthcare system a lot of money, they are killing us all and ruining our planet.
Indeed, DrRich himself was sharpening his pitchfork, when a thought occurred to him.
The paper in the International Journal of Epidemiology comports to the classical scholastic practice of “lectio,” whereby a learned person expounds on a certain interpretation of the approved texts, and allows no dissension or questioning. But scholasticism also offers a process for “disputatio,” whereby alternative interpretations of the approved texts are permitted to be offered, and the two viewpoints are then subjected to logical analysis through which the truth is determined. (Though in classical scholasticism, the “truth” is ultimately determined by the scholar who delivered the original lectio, and the disputant is put in his/her place.*)
*This, of course is where Martin Luther went wrong. The 95 Theses he nailed to the church door at Wittenberg was essentially an offer to engage in a classical scholastic “disputatio.” He was merely inviting a debate, like any other scholastic debate, and nothing more. The clergy, however, proved a bit too easily offended, and Luther proved a bit too tetchy, and the intended academic exercise turned into 300-years of bloodshed. DrRich sincerely hopes to avoid such a result here.
So in the spirit of Environmental Scholasticism (but for the ultimate purpose of discovering whether the healthcare system ought to cure, ignore or euthanize the obese), DrRich would like to propose an alternative interpretation of the argument that the obese are causing global warming. That is, he will offer a disputation.
The logic of the two eminent scholars Edwards and Roberts, once you wade through the incredible morass of scientific-sounding language they have produced, essentially rests on two arguments. First, that the obese require more food energy for their basal metabolic requirements, and second, that because they are so fat they travel in cars (and very big cars at that) much more than normal people do. For these two reasons the obese produce way more carbon emissions than they are supposed to. The authors go on to calculate the excess carbon emissions produced by the obese via the aforesaid impressive chain of assumptions and estimations, and the magnitude of that excess shows us plainly that the fat are largely to blame for global warming.
This is when it occurred to DrRich that both of the basic arguments of Professors Edwards and Roberts can be easily countered, well within the bounds of the scholastic arts, using only the approved texts and without introducing any new (which is to say, heretical) data.
So, to their lectio, DrRich advances this disputation:
First, DrRich asserts that while the basal metabolic rates of the fat are indeed higher than those of the thin, one reason the thin are thin is that their non-basal metabolism is high. That is, often they habitually engage in exercise, even running marathons and triathalons, which burns many calories and produces much CO2. Scientific studies have shown that the obese tend to be still, serene, relatively inanimate. On the other hand thin people are fidgety, they pace about, wave their hands, bounce their legs, and excrete much CO2 through largely habitual and non-useful activity. Perhaps we should punish the calorie-burning thin rather than the fat. At least when the obese burn calories they are generally doing something useful.
Second, while thin people do ambulate more than the obese (indeed, this is DrRich’s first point), the assumption that the obese must make up that mileage by driving cars is entirely ridiculous. The thin actually drive far more than the obese, because they have places to go and things to do, and they’re in a hurry to get there and do it. In contrast the obese are efficient in their movements, they preserve their energy. Thus, they do not drive to the grocery for a pint of milk on a whim. They plan their trips carefully, and shop for the entire week with one trip. There is no evidence that the obese require more support from internal combustion engines than do the thin, and simple observation in fact suggests the opposite.
DrRich could, with some effort, produce a paper just as scientific-sounding as that of the Professors to “prove” his points, but will not do so here. Instead, he will just state his points as bald assertions – which (despite all the fancy math they attached to it) is just what his opponents have done.
DrRich maintains that his two assertions – which entirely counterbalance those of his opponents – make his argument equally compelling to theirs. So thus far we have a draw. But DrRich’s third assertion, which follows, wins the day.
To wit: The obese are unarguably sequestering carbon.
Storing fat, in fact, is simply a relatively efficient way to store carbon. The obese consume massive amounts of carbon in the form of food, and then they fail to burn it off (unlike thin people, who convert their food to CO2 immediately through their habitually wasteful activities). Instead, the obese store their carbon intake in massive reservoirs of fatty tissue, taking it out of circulation forever, and removing it from the carbon cycle which (we find) is so fatally damaging to the earth. Indeed (at least according to the zero-sum crowd for whom redistribution is invariably the answer to all problems), the more food consumed by the obese, the less food remains available for the thin people who would just go ahead and metabolize it, with all their jogging and whatnot, excreting lots of excess CO2 in the process.
When we finally institute our cap-and-trade economy, the obese should get a tax break based on their weight.
Carbon sequestration, of course, is one of the holy grails for environmentalists. Lots of methods for sequestration have been proposed, but none seem particularly practical. One method that has been considered is called “Biomass Burial,” in which we would take some form of biomass (plants have been the main source proposed) and bury it under the earth. The carbon from the buried biomass will stay in the ground, and will not contribute to global warming, at least not for a long time. (This is how fossil fuels are said to form in the first place.)
As long as we insist that fat people are buried (preferably after they die), and make cremation of the obese illegal, then putting the obese into the ground will constitute the much-sought biomass burial. When we bury deceased fat people, it is plain to see that we are removing tons and tons of carbon from the carbon cycle and thus from the atmosphere, and instead sequestering it in the ground. It brings a tear to DrRich’s eye to imagine that his king-sized Uncle Harry, gone now for the better part of three decades, by virtue of all that carbon he took with him under the earth continues to make the world a better place for all us former kids he used to delight with his card tricks and his stupid jokes.
And finally, this happy conclusion at which we have arrived – that the obese actually reduce global warming – at last informs those of us who are interested in healthcare how we ought to behave toward the obese. As long as fat people are maintaining (or better yet adding to) their weight – that is, as long as they continue to remove large amounts of carbon from circulation – we should encourage their continued good health. If, however, they start exercising or in some other fashion begin to burn off their large carbon deposits, then of course we might logically withhold medical care from them, or even encourage euthanasia.
But please, for the love of our precious planet and for the sake of our polar bear citizens, let us not discriminate against the obese, or discourage them from their important work.
DrRich explains it all in, Fixing American Healthcare – Wonkonians, Gekkonians and the Grand Unification Theory of Healthcare.
DrRich is relieved to learn that the world’s most famous global warming experts have now been exonerated by three separate formal reviews. Dr. Michael Mann from Penn State University was cleared by a review conducted by Penn State University. Dr. Phil Jones, Director of the University of East Anglia’s Climate Research Unit (CRU), was cleared by a review conducted by the University of East Anglia, and also by a four-member “independent panel,” one of whose members was Prof. Geoffrey Boulton, a personage who had been on the faculty of East Anglia’s School of Environmental Sciences for 18 years, and who (prior to being placed on the “independent panel”) had been a vocal defender of Dr. Jones’ actions regarding Climategate.
Right-wing global-warming-deniers, of course, have decried the results of these reviews as a “whitewash,” pointing out, among other things, that Penn State and East Anglia both continue to receive tens of millions of dollars in federal “research” funds so they can continue to prove that global warming a) exists, and b) is man-made, thus suggesting that these institutions were determined to acquit their star grantsmen of scientific misconduct no matter what the objective findings. This kind of whitewash, they say, not only supports the global warming “hoax,” but even worse, further undermines the integrity of the scientific process upon which so much of modern society so utterly relies.
Of course, if right-wingers are correct, then reversing modern society and putting us all back in the glorious horse-and-buggy days is the very goal of the global warming mavens. (DrRich, a student of history, is well aware of how difficult it must have been 110 years ago to walk the streets of New York City without ending up splattered with dung to your knees, and he wonders what life would be like today, navigating the highways and byways of America, if all 300 million of us were relegated again to modes of transportation that defecate nearly continuously.)
It must be admitted, by anyone who has perused some of the leaked e-mails sent and received by Dr. Jones (making it doubtful that any of the three review panels had actually done so), that from any really objective viewpoint the global warming experts had engaged in some very questionable behaviors, which appear to have been aimed at advancing their theories, and suppressing any opposition, by any means at their disposal. The e-mails depict Jones and prominent colleagues discussing how to “tweak” climate change data in order to hide such embarrassing climatic phenomena as the Medieval warming period, “the little ice age” that followed it, and the global cooling we’ve been seeing over the past decade. Including these historical temperature fluctuations in their data would make their famous hockey stick graph look less like a hockey stick, and more like the random profile of a mountain range. (And once Al Gore won an Oscar for showing slides of the hockey stick, that was not an option.) They also collaborated to “control” the peer-review process so that only the “right” peers would be doing the reviewing, and the “wrong” peers would be cut off altogether. And, as a final deft touch, they all shared electronic high-fives when a noted global warming skeptic died unexpectedly.
Then, of course, just a few days after the embarrassing e-mail leak, the CRU was forced to admit (thanks to Britain’s Freedom of Information act) that they had, apparently intentionally, destroyed all the raw temperature data upon which their elaborate computer models were based. (They say they ran out of space to store it, apparently failing to recall the many forms of magnetic storage readily available to scientists today). The destruction of this data utterly precludes other scientists from checking, and attempting to reproduce, the critical predictive model upon which the theory of man-made global warming largely rests.
This inconvenient truth renders their climate change model a black box. It places the rest of us in the position of having to “just trust” the global warming experts, upon whose work (for instance) President Obama bases his proposal for a fundamental change in our economy, our way of life, and our foundational political philosophy.
So it is perhaps somewhat understandable that right-wingers object so vociferously to the alleged “whitewash.” Their general complaint seems to be that the scientific process should always be pristinely unbiased, and that the gross bias so clearly displayed by global warming experts in this case not only corrupts the case for global warming, but also corrupts the scientific process itself, to the extent that every scientist in the world should be screaming for the heads of the miscreants, and indeed, must do so, to salvage the very legitimacy of science.
DrRich is sympathetic to the argument that the implications of Climategate are troublesome, but not because the climatologists have behaved in a terribly biased way. Biased thinking within a scientific debate is not only common practice, but also it is a critically important part of the process. Raw contention between very biased scientists with very different viewpoints is how we get scientific progress in the first place. DrRich is not even disturbed that the currently-entrenched global warming experts have used their position of relative strength to suppress the upstarts who dared to oppose them. That’s also pretty much standard behavior in the academy, and it, too, serves a useful purpose.
Rather, what’s troublesome about the global warming controversy is that outside authorities of incredible power have taken an extraordinarily strong position in the scientific debate, and have lent their massive influence to one particular side. Whenever this sort of thing happens, the “winner” of the scientific contest is often not determined by superior scientific merit, but by other factors.
Scientific progress works like this: A new theory is conceptualized to explain some phenomenon, usually by a whippersnapper of one variety or another. The entrenched experts, whose careers, reputations, social status, incomes, and sexual fulfillment are based on the old conception, find the new theory to be absurdly wrong (or in some cases heretical), and probably dangerous. Since preserving the “truth” is the highest calling of all, the experts engage in every device they can muster (from “controlling” the peer-review process to burning heretics at the stake) to see that the truth (as they define it) prevails.
To the uninitiated – and certainly to the upstart whippersnappers – this process seems primitive and unkind. But actually it is quite useful and practical, and in the long term is very beneficial to mankind. For most of the new theories thought up by whippersnappers are, in fact, garbage. In order to break through the imposing barriers of bias constructed by the entrenched experts, the novices really have to believe in what they are espousing, and their new theory, ultimately, has to actually offer some substantial improvement over the currently accepted one. The whippersnapper, if very lucky, finally becomes the foundation of a new generation of experts – and the process begins all over again. Hence, science progresses. The process is geared toward the gradual discovery of truth, and not toward the nurturing and vindication of whippersnappers. And eventually, truth always does prevail – and often it does so within just a few generations.
In the short term, of course, this process can look very messy and unfair. It is certainly subject to great bias. In fact, we take pains to set up the accepted experts with lots of grant money, prestige, titles, &c. precisely to make sure they’ll do everything they can to preserve the status quo. We do this so that when the paradigm actually shifts, it shifts because the merits of the new paradigm are sufficient to overcome all the bias – and not because of a whim. This process keeps science – and society – from being whipsawed this way and that.
Where the process breaks down is when a powerful outside influence – say, a religion or a government – firmly takes a side in the scientific debate. For example, just ask any of the would-be astronomers from the time of the pre-Renaissance Popes how well the scientific process of competing biases worked out for them.
It seems apparent, to DrRich at least, that most of the world’s governments, including ours, find that the bias of the global warming experts very nicely aligns with the historical bias of governments, which is to say, accruing ever more power over the endeavors of the people. It may possibly be for this reason that governments have thrown in – body and soul – with this side of the debate, to the extent that “global warming” has now become largely sacrosanct. Man-made global warming is officially deemed (like the 2011 U.S. Budget) to be “settled science,” and is beyond reasonable question. No new scientific evidence to the contrary is admissible. Competing viewpoints are, in fact, heretical. And even when gross evidence of academic misbehavior on the part of global warming experts is revealed, that evidence is excused, paved over and ignored.
This mindset is the only one that fully explains the tone and the content of the Climategate e-mails, and the subsequent exoneration of the climate scientists who wrote them.
Most readers, DrRich expects, agree with him to this point. (For, how could it be otherwise?) But, you may be asking, what does any of this have to do with healthcare, or more specifically, with healthcare rationing?
As we enter into a new era of healthcare, where medical decisions will be taken out of the hands of imperfect physicians and entrusted to panels of federally-sanctioned (and thus pretty much infallible) experts, who will analyze the available data and construct the guidelines of behavior by which all physicians will henceforth be judged, we ought to keep the problem of unbalanced bias in mind.
Today we have a healthcare system in which competing interests, and their competing biases, battle for prominence. The process is messy, ugly and often unfair, but with long-term results that are generally reasonably favorable. Or at least, the damage is generally contained. But we are headed toward a healthcare system in which only one great interest – that of our government, with its overwhelming bias toward cutting the cost of healthcare – will predominate.
A great fallacy under which many of us labor is that the government has no strong biases, and that a process overseen by the government will be inherently far more “fair” than a process that incorporates the biases of for-profit enterprises. But in truth, the government is the biggest, meanest, special interest of all. And like all sovereign authorities, this one is not only able to, but is expected to get the results it deems necessary by the measured application of violence.
For those who believe any government, anywhere, which has total control over any human enterprise can still behave fairly, DrRich begs you to please have another look at history. When we allow government (and its agents) to have the only say over medical decisions, then those medical decisions will be made with all the robust, open-minded, free, give-and-take exchange of ideas we are seeing from the global warming experts today. And while medical progress – like progress in general – cannot be forever halted, it will become as sclerotic as the scientific progress enjoyed by those pre-Renaissance astronomers.
The scientific process will always be biased. Where we invite serious damage is where we admit only one form of bias, and forcibly stifle all the rest. It’s bad for climate science, and it will be bad for healthcare.
Since the late 1990s, American physicians have labored under a set of tortuous documentation requirements imposed upon them by our government. The E&M guidelines (for “evaluation and management”), apply to the documentation that physicians are now obligated to provide in support of their Medicare billing. The E&M guidelines, first instituted in 1995 and revised in 1997, were part of the Clintons’ great fraud reduction initiative. Ostensibly, the strict documentation requirements reduce the opportunity for fraudulent billing.
While doctors initially railed against the E&M guidelines, they now suffer them in relative silence. The E&M guidelines have become, in fact, just one more hurdle which doctors must navigate as they pick their way through the vast obstacle course that now defines the practice of American medicine. Indeed, younger doctors accept the odious documentation requirements as a matter of course, knowing nothing better, just as children born into the direst third-world slums accept their abject poverty without notable complaint.
But occasionally, physicians of a certain age, dimly remembering how it ought to be, will still complain about these guidelines. One of these is revered fellow blogger DB, who (unlike DrRich) is still in the trenches, and must deal with – and try to teach trainees how to navigate through – this abomination on a daily basis. Accordingly, DB is periodically moved to remind us of what he graciously believes to be the unintended consequences resulting from the E&M guidelines, which is to say, DB seeks to remind us that current medical documentation requirements get in the way of good and efficient patient care.
For some, however, even this sort of mild-mannered, exceedingly polite objection is not to be countenanced. One of DB’s correspondents fired back at him:
“The templates are there to serve as a guide, not a hinderance. If you don’t like your “guide” then work to change it. You shouldn’t look at this “guide” as a form of billing, but rather as a guide in making sure you have covered your bases when seeing the patient. Proper documentation can lead to quality care and positive patient outcomes.”
This, indeed, is the official government position on E&M guidelines. It is so official, in fact, that it moves DrRich to wonder whether Cass Sunstein has actually implemented his well-documented anti-conspiracy strategy, and thus has dispatched armies of government-approved agents to monitor and actively counter “untruths” which are unfriendly to government aims, wherever they are found.
In any case, DrRich is not as polite (or as circumspect) as DB, and so he will say it outright.
The E&M guidelines were established for the specific purpose of controlling the behavior of physicians, to further the goals of covert rationing.
First and foremost, they create a Regulatory Speed Trap of the first order, so that with each and every patient encounter the item that will be foremost in the physician’s mind is not the needs of the patient, but in filling out the complex documentation in such a way as to avoid the appearance of committing a fraud. In practical terms, this means filling out the documentation so as to blend in with the masses, so that one’s records will be passed over by the sharp eyes of the greedy forensic accountants (who are paid by commission for detecting instances of substandard documentation, which are now construed as “fraud”), or even worse, by the sophisticated software now being deployed to detect ever-more nuanced gradations of “outliers.”
A classic post by The Happy Hospitalist describes the mysteries of E&M documentation better than any other attempt DrRich has seen. HH’s description of the documentation hoops through which physicians now must jump is detailed enough that it’s actually difficult to read. Which is the point.
Through their utter opacity and complexity, only partially reflected by the 48 pages of dense prose that comprise them, the E&M rules (for “rules” is what they are) in fact greatly magnify the doctor’s opportunity for making inadvertent documentation errors, and thus of producing a “fraudulent” bill. HH’s post nicely demonstrates how writing a progress note according to the E&M rules requires assembling a complicated set of “elements” from Column A and Column B, as from a Chinese menu, for each of four subject areas of the patient encounter – the history, the physical exam, the assessment, and the plan. Then somehow, one must translate the result (which reads like – and often is – a computer-generated form letter) into the proper, fully-supported billing code.
Even if this mess led to a straightforward means of determining proper billing codes (which it does not), it results in a medical progress note that is virtually undecipherable. This means that when another doctor (or even the same doctor on a different day) tries to read the progress notes to figure out what’s been going on with the patient (which used to be the point of medical progress notes, before they became primarily a vehicle for auditors), they cannot. Compliance with the E&M guidelines can thus actively confound patient care.
When the E&M guidelines were first introduced, they were recognized immediately by doctors as a complete abomination. Indeed, the great hue and cry from angry physicians (and the arrival on the scene of a new Republican administration) caused the Secretary of HHS to appoint a special commission to review the E&M guidelines in 2001. The commission concluded that indeed, the E&M guidelines were entirely counterproductive to patient care, and in June, 2002 voted (20-1) to recommend abandoning them altogether.
But HHS declined to follow the recommendations of its own commission, instead leaving the E&M guidelines in force “temporarily,” and vaguely promising to revise them “soon” in order to make them less dangerous to patient care – knowing full well that the saurian lassitude of the bureaucracy would easily outlast the fleeting indignation of the medical community.
(This simple example ought to teach us how difficult it will be to roll-back any of our new healthcare reforms in the future, even ones that are officially deemed to be harmful.)
Accordingly, not only has HHS failed to take (or, alternately, succeeded in not taking) steps to revise the E&M guidelines, they also have vigorously pressed forward with audits and prosecutions for the federal crime of healthcare fraud, based on physicians’ inadequate compliance with them. And, as the bureaucrats must have predicted, there has not been any substantial noise from doctors about revising these guidelines for several years now.
What’s more, there never will be. Save for the occasional exhortation from an old fossil (sorry, DB), the E&M guidelines have been fully absorbed into modern medical practice. They have become normal.
Accordingly, a multi-million dollar industry has sprung up to help physicians better comply with these coding guidelines. Physicians across the country are spending the time and money allotted for their continuing medical education learning to become better accountants, rather than better physicians.
Which brings DrRich to his last point: It is not actually possible to follow the E&M guidelines to anyone’s satisfaction.
There is, in fact, no “correct” way to code, because correct coding is impossible. This verity was proven a few years ago when a group of specialized government-sanctioned coders took a sample of typical doctor-patient visits, coded them according to their own E&M guidelines – and they all got different answers. (The results of this study were published in the Annals of Emergency Medicine in September, 2002.)
Obviously, then, since there is no “right” way to comply with the coding rules, any doctor toward whom the fickle finger of fate points the Feds is very likely to be found guilty of abuse, if not outright fraud. And what we’ve got here is a well-documented, openly acknowledged, peer-reviewed and published Regulatory Speed Trap.
Here’s what happens to doctors who are found to commit coding abuse (which is to say, to any doctors who are visited by Federally-sanctioned auditors):
1) A small sample of their patients’ charts is audited.
2) The error rate (with the auditor determining retrospectively what an error is) is calculated for that sample, then that rate is applied by extrapolation to all the Medicare billing the doctor has done for the past 6 years (the statute of limitations).
3) For each violation in coding the doctor is calculated to have committed during those six years, the doctor must pay a) triple the amount of restitution, and b) $11,000.00 (per coding violation).
It is not unusual for audited doctors to be hit with hundreds if not thousands of coding violations over a 6-year period, and the fines will almost always amount to well over 7 figures, if not 8. Even rich doctors usually can’t afford that kind of damage. However – if it’s just abuse the doctor has committed and not fraud – often the Feds may offer a settlement deal in the low 7 figures.
And here’s what happens if the coding violations are judged to be fraudulent (which, unfortunately, often appears a somewhat arbitrary designation):
1-3) All the above.
In summary, DB makes a very legitimate point, and has made this point several times over several years. Namely, the E&M coding rules are highly counterproductive to patient care. They produce medical records that are fundamentally undecipherable regarding actual medical content, even by medical professionals; and they distract physicians, with every patient encounter, into a fraud-avoidance exercise.
Sadly, however, DrRich does not believe that merely pointing out the harm being caused to thousands of patients each and every day by the E&M guidelines will do any good. Believing that it might do some good to call the Feds’ attention to it assumes that the harm is an unintended consequence, or at least, that it would be considered too high a price to pay.
This, DrRich feels obligated to reiterate, is demonstrably not the case. The Feds know that the E&M guidelines are harmful to patient care. Their own commission came to that very conclusion in 2002. The Feds know that failing to comply perfectly with the E&M guidelines in each and every case does not really indicate fraud and/or abuse, but is the necessary outcome when you institute a complex set of rules that not even the government’s own coders can interpret. Reminding the Feds of these facts, in public, may make them angry, but it will not change their position on E&M guidelines.
That the Feds continue to impose the E&M guidelines on physicians, despite the harm that they know this causes, tells us something very important about their underlying motives. When you are in the business of covertly rationing healthcare, controlling the physicians is Job One. And as George Orwell observed for us, when you want to control the behavior of some population, a critical step is to control the mode, the rules, and even the very language of communication.
That physicians continue to comply with such oppressions, despite the harm they know this causes, and (with notable exceptions) without serious complaint, tells us something important about them, too. DrRich would rather not say what that is.
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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This week, the Archives of Internal Medicine published four (four!) articles assaulting the legitimacy and the importance of the JUPITER trial, a landmark clinical study published in 2008, which showed that certain apparently healthy patients with normal cholesterol levels had markedly improved cardiovascular outcomes when taking a statin drug.
Superficially, at least, the JUPITER study appears to have been pretty straightforward. Nearly 18,000 men and women from 26 countries who had “normal” cholesterol levels but elevated C-reactive protein (CRP) levels were randomized to receive either the statin drug Crestor, or a placebo. CRP is a non-specific marker of inflammation, and an increased CRP blood level is thought to represent inflammation within the blood vessels, and is a known risk factor for heart attack and stroke. The study was stopped after a little less than two years, when the study’s independent Data Safety Monitoring Board (DSMB) determined that it would be unethical to continue. For, at that point, individuals taking the statin had a 20% reduction in overall mortality, a dramatic reduction in heart attacks, a 50% reduction in stroke, and a 40% reduction in venous thrombosis and pulmonary embolism. All these findings were highly statistically significant.
This study is noteworthy because it is the first large randomized trial to show that taking a statin can markedly reduce the incidence of some very nasty cardiovascular outcomes in people who are considered to have “normal” cholesterol levels. (Notably, typical LDL cholesterol levels among primitive hunting/gathering cultures is around 50 mg/dL, instead of the 100 – 120 mg/dL we consider to be normal. These primitive folks have an extremely low incidence of cardiovascular disease, so maybe humans’ optimal cholesterol level is much lower than we now think. On the other hand, the low risk of cardiovascular disease among hunters/gatherers may instead be related to the fact that many of them are consumed by various species of carnivores before they’re 30.)
To be sure, the JUPITER trial was far from perfect. Because of its design, it could not (and did not) tell us whether the beneficial outcome is specific to Crestor, or is a class effect of all statins (which seems very likely). It did not tell us whether reducing CRP levels is itself beneficial, or even whether using CRP as a screening tool is actually helpful. (The people enrolled in this trial tended to have several other risk factors, such as being overweight, having metabolic syndrome, and smoking, and it is not clear how much additional risk elevated CRP levels really added in this population.) And this trial did not tell us the risks of lifelong, or even very long-term, Crestor therapy.
But JUPITER did tell us something that is very useful to know, and with a very high degree of statistical surety: Giving Crestor to patients similar to the ones enrolled in this study can be expected to result in significantly and substantially improved cardiovascular outcomes, and in a relatively short period of time.
If medicine were practiced the way it ought to be – where the doctor takes the available evidence, as imperfect as it always is, and applies it to each of her individual patients – then the incompleteness of answers from the JUPITER trial would present no special problems. After all, doctors never have all the answers when they help patients make decisions. So, in this case the doctor would discuss the pros and cons of statin therapy – the risks, the potential benefits, and all the quite important unknowns – and place the decision in the perspective of what might be gained if the patient instead took pains to control their weight, exercise, diet, smoking, etc. At the end of the day, some patients would insist on avoiding drug therapy at all costs; others would insist on Crestor and nothing else; yet others would choose to try a much cheaper generic statin; and some would even opt (believe it or not) for a trial of lifestyle changes before deciding on statin therapy. In other words, there is a range of reasonable options given the limitations of our knowledge, as there often is in clinical medicine. As time goes by, more scientific evidence is often brought to bear and clinical decisions can become more informed. But whatever the state of the evidence, doctors and patients can generally get by without violating too severely any ethical or medical precepts that would cause objective and neutral observers to complain very much.
But in recent years, and especially now, as we bravely embark on our new healthcare system, this is not how doctors will practice medicine. Instead, they will practice medicine by guidelines. These guidelines (which, in modern medical parlance, is a euphemism for “directives”) are to be handed down from panels of experts, identified and assembled by members of the executive branch of the federal government.
And this makes the stakes very high when it comes to a clinical trial like JUPITER. For guidelines do not permit a range of actions tailored to fit individual patients (consistent with the uncertainties inherent in the results of any clinical trial). Instead, guidelines will seek to take one of two possible positions. That is, under a paradigm of medicine-by-guidelines, the results of clinical trials generally cannot be permitted to remain imperfect or nuanced or subject to individual application, but must be resolved by a central panel of government-issue experts into a binary system – yes (do it) or no (don’t do it). In the case of JUPITER, the guidelines must decide whether or not to recommend Crestor to patients like the ones enrolled in the study, at a potential cost of several billion dollars a year. It should be obvious that the answer which would be more pleasant to the ends of the central authority, and by a large margin, would be: No, don’t adopt the JUPITER results into clinical practice.
However, the expert panels which are called for by our new healthcare legislation have not been formulated yet, and we are still operating under the “old” rules. So, still subject to all the duress which is created by unfortunately-resolved clinical trials like this one, the FDA, somewhat reluctantly, approved the use of Crestor for JUPITER-like patients in late 2009. That approval, of course, is subject to review by the new expert panels, whenever they are assembled.
This, DrRich submits for your consideration, is likely what instigated the almost violently anti-JUPITER issue of the Archives this week. DrRich theorizes that what we’ve got here is a bunch of wannabe federally-sanctioned experts, auditioning for positions on the expert panels. What better way to get the Fed’s attention than to let them know that you are of the appropriate frame of mind to assiduously seek out scientific-sounding arguments to discount the straightforward and compelling, but fiscally unfortunate, results of a well-known clinical trial?
Of the four papers appearing in this week’s Archives, three are more-or-less legitimate academic articles that make reasonable points, but do no harm to the main result of JUPITER. The fourth is a straightforward polemic, which has no place in a peer-reviewed medical journal, and whose very presence, DrRich believes, very strongly suggests that the editors of the Archives themselves must be auditioning for the Fed’s expert panel.
So as not to bore his readers any more than necessary, DrRich will make short work of the three reasonably legitimate articles in this issue. One pointed out that JUPITER did not tease out the real importance of CRP levels, or whether lowering those levels is useful. This is true, but that fact does not touch the main conclusion of JUPITER. Another article was a meta-analysis which incorporated several other primary prevention trials using statins, and concluded that there is no overall benefit to statins in primary prevention patients. Aside from the usual problems inherent in meta-analyses, a) the JUPITER study looked at a specific population of primary prevention patients not addressed by these other studies, and b) since JUPITER is the first study to show a benefit in using statins for primary prevention, it is a foregone conclusion that if you assemble enough of the previous, negative studies and lump them together with JUPITER in a meta-analysis, you will be able to dilute the results of JUPITER sufficiently to achieve an overall negative result. Actually doing such a meta-analysis, then, is merely an exercise in math, not in revelation.
The third article criticized the JUPITER DSMB for stopping the trial earlier than originally planned. The DSMB, however, had no real choice in the matter – ethically or legally – given the striking statistical significance of the benefit seen with Crestor. When a patient signs an informed consent agreement to participate in a clinical trial, part of that “contract,” a part required by law, is the statement to the effect that if information comes to light during the course of the study that might impact a patient’s willingness to continue participating, that information must be made available. The fact that the Crestor branch of the study was found to have markedly improved survival, fewer strokes and heart attacks, etc., than the placebo branch, clearly constitutes such information. Stopping the study when they did was not “premature;” continuing the study would have been illegitimate. This is why independent DSMBs exist in the first place – to protect the rights and welfare of the research subjects under the fiduciary agreement that comprises informed consent.
The fourth article is more striking (and more fun) than the other three. Interestingly, it is categorized by the Archives as an “Original Investigation,” despite the fact that it describes no investigation of any kind whatsoever – original or derivative. It merely revisits the data from JUPITER (in a spectacularly biased manner), and offers a spate of ad hominem attacks, alleging bias to the point of corruption, without any supporting evidence, against JUPITER’s sponsor, its investigators, and most astoundingly, the chair of the DSMB (who is a well known and highly respected figure, especially known and revered for his complete objectivity and lack of bias). If such an article has any place at all in a peer-reviewed medical journal – which DrRich doubts – it ought to be clearly labeled as an opinion piece, and not as a piece of original research. Whatever it may be, it’s not that.
But the most delicious aspect of this fourth article is that two of its authors, including its lead author, are members of a fringe medical group known as The International Network of Cholesterol Skeptics (THINCS), whose stated mission is to “oppose” the notion that high cholesterol and animal fat play a role in cardiovascular disease. Members of THINCS also take an extraordinarily strong position opposing statins for any clinical use whatsoever. (One might actually assume that, since JUPITER shows that cardiovascular outcomes can be improved by statins in people with normal cholesterol levels, the THINCS would embrace the study as evidence that perhaps cholesterol is not as important as it’s cracked up to be. But apparently, this argument is completely negated by the fact that statins were the vehicle for making it. Many in the anti-statin crowd would object to statins even if they were proven to cure heart disease, cancer, baldness, and obesity AND produced fine and durable erections upon demand.)
The best part of all this is that the astounding anti-cholesterol, anti-statin bias of the authors was not disclosed in their article – whose main thrust, again, was to criticize the disclosed biases of the JUPITER investigators.
The excellent Pharmalot blog noted this irony, and contacted Rita Redberg (editor of the Archives) and Michel de Lorgeril (THINCS-master and prime author of the fourth article) to ask them why the association with THINCS was not disclosed.
“I’m not clear this is an undisclosed conflict. The policy mentions a personal relationship that could influence one’s work. I think that could be a big stretch. My initial impression is the group has an intellectual message, but doesn’t fit as a personal relationship that could effect the authors’ work.”
“[While it is] very important to disclose financial [emphasis DrRich's] conflicts of interest that can influence our way of working and thinking about cholesterol and statins, there is so far no obligation to provide a CV each time we publish any thing…May I underline the fact that being a member of THINCS – not a group of terrorists, mainly a club of very kind retired scientists with whom I have interesting and open discussion – is not a conflict of interest?”
DrRich may be old fashioned, but he thinks that being a member of an “out there” group like THINCS, which appears to advance selected and distorted data on its website aimed at furthering its stated mission of “opposing” (not investigating or questioning) the cholesterol hypothesis and the use of statins, might make one prone to a bit of bias when writing a broadside critiquing a study like JUPITER, and loudly criticizing anyone associated with that study for their bias. This sort of bias (demonstrably rooted in a willingness to select/ignore/distort data in order to make a preconceived point) is likely to be as strong as any that might accompany, for instance, receiving a stipend from a statin company for participating in clinical research. Membership in THINCS may not preclude one from writing such an article, but DrRich thinks the association at least ought to be disclosed, just as financial relationships must be disclosed.
DrRich has a hard time explaining how this can happen with a prestigious medical journal like the Archives. But like Sherlock Holmes says, when you have eliminated the impossible (such as, the idea that this article deserved to be published in its current form), whatever remains, however improbable, must be the truth.
And this is why DrRich can only conclude that several of the authors appearing in this week’s issue of the Archives of Internal Medicine, along with its editor, are in the mode of ingratiating themselves to the sundry officials and czars within the Obama administration who will be assembling the expert medical panels, those panels which will be making the momentous decisions that will determine the flow of hundreds of billions of dollars, and (forgive me) of life and death.
We wish them the best of luck in their audition, and will be monitoring the memberships of the new panels with interest, to see if any of our new friends are ultimately successful.
DrRich critiques more arguments for withholding Crestor here.
de Lorgeril M, Salen P, Abramson J, et al. Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy. A critical reappraisal. Arch Intern Med. 2010; 170:1032-1036.
Kaul S, Morrissey RP, Diamond GA. By Jove! What is a clinician to make of JUPITER? Arch Intern Med. 2010; 170:1073-1077.
Ray KK, Seshasai SRK, Erqou S, et al. Statins and all-cause mortality in high-risk primary prevention. A meta-analysis of 11 randomized controlled trials involving 65 229 participants. Arch Intern Med. 2010; 170:1024-1031.
Green L A. Cholesterol-lowering therapy for primary prevention. Still much we don’t know. Arch Intern Med. 2010; 170:1007-1008.