Crestor, Guidelines, Rationing and Other CRP

November 13th, 2008 by DrRich

The JUPITER trial, reported this week at the American Heart Association Scientific Sessions and simultaneously published in the New England Journal of Medicine, has created quite a stir in the mass media and in the blogosphere. DrRich would like to do his bit in flaming the controversy.

On its surface the study and its results are 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. Patients randomized to Crestor, after an average treatment period of 1.9 years, had a highly significant 44% reduction in a composite endpoint that included heart attack, stroke, the need for stenting or bypass surgery, and cardiovascular death. Both CRP and cholesterol levels were also significantly reduced in patients taking Crestor.

This study is noteworthy because it is the first large randomized trial to show that Crestor (or any 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 people 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 bears before they’re 30.)

So here’s what we know from the JUPITER trial: giving Crestor to patients similar to the ones enrolled in this study can be expected to significantly and substantially improve their cardiovascular outcomes, and in a relatively short period of time.

But, as with any clinical trial, this one does not answer all the questions that we would like to have answered.

This trial, for instance, does not tell us whether the beneficial outcome is specific to Crestor, or is a class effect of all statins. (DrRich believes it is very likely to be a class effect, since the statins all tend to behave similarly in virtually every other way.) This trial does not tell us whether reducing CRP levels is beneficial - it only tells us that giving Crestor to people with high CRP levels is beneficial. (As Dr. Centor points out, it is time to begin thinking of statins as plaque-stabilizing drugs instead of cholesterol-lowering drugs; their benefit may not rely on lowering either CRP or cholesterol.) It does not tell us whether using CRP as a screening tool is actually helpful. (Only patients whose CRP was elevated were enrolled in this study. Similar patients - that is, patients who tend to be overweight and have a fairly high incidence of metabolic syndrome and a relatively high incidence of smoking -  but with normal CRP levels, might have had the same outcome.) And this trial does not tell us the risks of lifelong Crestor therapy. (DrRich notes, however, that statins have been in widespread clinical use for nearly 20 years, and seem unlikely to hold very many surprises at this point.)

So there’s a lot we still don’t know, and much of what we don’t know would be important to any doctor counseling a patient who wants to reduce their risk of cardiovascular disease.

But still, there should be no controversy here. 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 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 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 (hopefully) become more and more effective. 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 we don’t practice medicine the way it ought to be. We practice it according to guidelines.

And this makes the stakes very high when it comes to a clinical trial like JUPITER. For guidelines do not generally permit a range of actions tailored to fit individual patients - they generally present a binary answer. In this case, the binary answer yields either no change in clinical practice (and no change in spending), or a change in clinical practice (and an increase in spending, on Crestor, amounting to several billion dollars a year).

So as one might predict, a controversy has broken out.

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 - 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 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. There is furthermore a subset of this group who believe that statins, in particular, are the devil’s work, and represent some sort of effort on the part of the pharmaceutical companies (all of which seem to market a statin of one variety or another) to enslave every American. These people, one can only surmise, would object to statins even if they were proven to cure heart disease, cancer, baldness, obesity AND to produce fine and durable erections upon demand.

DrRich simply points out 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 before they are allowed to sell a new product, or 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 AstraZeneca 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 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. From what DrRich has seen, most of the statistics 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 has thrown in a key summary sentence that has been greedily grasped by the antialterguidelinetarians, 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 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 will not make anyone wade through the reasons why, because he realizes that one or two of his readers might not enjoy statistical arguments. (Instead he will provide those reasons in this footnote.*) Suffice to say here 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 this widely-quoted summary statement by Hlatky suggests.

As illegitimate as this summary statement may be, let us accept it for a moment just for the sake of discussion, since that’s the data the antialterguidelinetarians 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. 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 it’s 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. 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 antialterguidelinetarians 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 outlined in the footnote.*  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, and the only real reason there’s any controversy 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 AstraZeneca 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 Corollary Four of the Grand Unification Theory of Healthcare: Covert rationing corrupts everything it touches.

*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 here - 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 analysing 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), 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 for 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.

Posted in General Rationing Issues, Cardiology Topics, Guidelines, Abuse of, Evil Drug Companies | 12 Comments »

Medical Grand Rounds, Vol 4, No. 41

July 1st, 2008 by DrRich

Welcome to Medical Grand Rounds, Volume 4, Number 41, July 1, 2008. This week, bloggers from across the Internet have submitted articles that will help us celebrate the 232nd birthday of the United States of America. Their patriotic postings, organized according to their relationship to the Founding, follow:

Lists of Grievances

Annie at Home of the Brave sets the tone for this week’s Grand Rounds. She does a brilliant job showing what the Founders might have said about the current state of the American healthcare system, in What They Were Saying: A Riff on the Declaration and Resolves of the First Continental Congress. The First Continental Congress, of course, met in 1774 to petition King George for a redress of grievances stemming from the Intolerable Acts. The King rebuffed their petition and a shooting war broke out the following year, which led to, well, quite a bit. (Faced with their own intolerable Acts, many doctors, in stark contrast to the Founders, simply keep their heads down and continue making those little marks on their Pay For Performance checklists.)

Ian Furst of Wait Time & Delayed Care is Canadian and knows something about healthcare and the bureaucracy (not that doctors in the U.S. have any excuse not to know the same thing). Ian analyzes the results of England’s 4-hour ER wait-time guarantee, and shows once again how bureaucrats tweaking one variable in a complex system always manage to create interesting unintended consequences. But, since these unintended consequences will always require further bureaucratic activities in order to produce corrections, they guarantee perpetual growth of the bureaucracy, and thus are seen, by the people who really matter, as exceedingly good things.

Speaking of the proper limits of government, Doc Gurley considers, in her post, Hope and Death, the implications of the California Assembly’s latest bill, essentially requiring doctors to tell patients when they are terminally ill. This information, no doubt, would substantially lower patients’ expectations, and patients with low expectations can be managed very cheaply. (Which explains the legislative impetus to become involved in such matters.) But as Doc Gurley points out, the definition of “terminally ill” is often in the eye of the beholder, and the definition favored by those running the healthcare budget may be quite different from the definition patients (and doctors, if left to their proper medical functions) would favor. Doctors not wanting to break the law (or expose themselves to yet another, particularly promising, form of healthcare fraud) will predictably begin shading the definition of “terminally ill” toward the cost-saving side, i.e., making the determination somewhat earlier than traditional (or proper). DrRich predicts that our faithful public servants will soon take note of the prolonged anguish that will ensue as a result of the newly prolonged (by legislation) duration of terminal illnesses, and their bureaucratic compassion will move them to legislate a mitigation; namely, a law requiring the easy availability of physician-assisted suicide.

The Happy Hospitalist this week offers one of his patented, in-depth analyses of the utter mess that Medicare has become, in This is What You Voted For. For a system that produces the exact opposite of what it says it wants to produce, you can hardly beat Medicare. Happy says, “Look out America, get ready for even lower access to cheap effective [primary] care and a highly expensive and wasteful proceduralization [by specialists] of your friends and family. . .Well America, this is what you voted for. I hope you’re ready to live with the consequences.” Taking into account the bizarre incentives, Byzantine inefficiencies, and systematized grievances that are provided in such luxurious abundance by Medicare, Happy (and DrRich) can only marvel in dazed wonderment that anyone thinks that turning the whole healthcare system over to these people is a good idea. Imagine our honored forebears clamoring to turn over the entire colonial economic system to the perpetrators of the Stamp Act!

And anyone who still thinks any government knows how (or can know how) to run a healthcare system should become a regular reader of Dr. John Crippen’s NHS Blog Doctor, to get a taste of what healthcare across the pond is really like. His recent posting, The Rise of the Healthcare Professionals, describes just a few examples of the systematized dumbing-down of healthcare that has accompanied England’s NHS, and will accompany any system in which codified policies, procedures, and guidelines, handed down from on-high and strictly enforced, replace genuine medical thought.

Inalienable Rights

DrRich has always been amused by those boutique diseases that doctors occasionally invent in order to justify new avenues for payment. Psychiatrists (in DrRich’s humble opinion) have been particularly adept at this game. Dr. Shock MD PhD gives us his opinion on the latest such neo-diagnosis - Internet Addiction. Dr. Shock, we are happy to note, is not enamored with this new disease, and to his very great credit finds in America’s founding documents an inalienable right to the Internet. All self respecting bloggers must unite against declaring as a disease the robust appreciation of the Internet!

The anonymous blogger who writes How to Cope With Pain wonders in Can I Still Blog? whether blogging is an inalienable right - and concludes that while it may be a right, the fact that something is a right does not necessarily relieve you of the attendant risks or consequences. So that’s why all those other physician-bloggers choose to remain anonymous! Is it too late to inform you that DrRich is actually a 58-year-old housewife from the upper Midwest who learned everything she knows about medicine from Dr. Kildare reruns?

Alvaro at Sharp Brains talks about the inalienable right of men and women to own functioning brains - and what they can do to keep them - in Why We Need Walking Book Clubs.

Theresa Chan at Rural Doctoring tells a painful story, in Another Reason Why Healthcare is Going Down the Toilet, documenting how some patients (and patients’ families) feel they have an inalienable right to all the time and toil they desire of physicians, and for free.

The Spirit of the Individual, That Which Made America Great

Rob, at Musings of a Distractable Mind, shows us that the independent, creative spirit that made America what it is remains alive and well - even in PCPs! DrRich has long maintained that PCPs need to think outside the box in order to salvage their profession, and in What are You Going to Do? Rob demonstrates thinking that is, uh, way outside the box.

Over at Insure Blog they’re talking about another aspect of the right to fend for yourself - this time, using a patient’s own cloned immune cells to treat cancer. This research, which comes from the UK, is not funded by the National Health Service, nor has the NHS expressed the least interest in it. So, one might say, the British government is keen to remain “independent” of potentially expensive cancer cures. Read about it in Interesting Cancer News.

David E. Williams at the Health Business Blog tells us about an idea whose time has surely come - enticing patients to take their medication by rewarding them with chances in a lottery. Now, what can be more American than that? Go read You gotta play to win.

Kim of Emergiblog reminds us in Give Me Empathy, or Give Me . . . Another Nurse, how, when we are sick and frightened, nothing can soothe us like the presence of a confident, knowledgeable and empathetic nurse. The continued empathy of nurses is quite remarkable to DrRich, who notes that nurses are under as much stress from the bureaucracy as are doctors. Add to that the stress from being expected to follow orders from those harried, frustrated, angry, not-always-clear-thinking doctors, while still doing the right thing for the patient - dual responsibilities that are not always 100% in alignment. Continued empathy under such challenging conditions can only be attributed to individual character and dedication.

Kerri of Six Until Me reminds us in My Own Shoes that knowledgeable, intelligent and rational patients will always take doctors’ recommendations under advisement, but may ultimately decide that their own personal situation is best served by some deviation from those recommendations. Such patients are not being “non-compliant;” they are considering the doctor’s advice within the context of the totality of their lives (which will always include data their doctors can never fully understand), and exercising their own individual judgment.

Christian Sinclair at Pallimed reports on the practice of hospice medicine during the ongoing Midwestern floods. His report reminds us of America’s greatest asset - the dedication, ingenuity and spirit of individual Americans - which is always most impressive under the toughest of circumstances.

Christine of You Don’t Look Sick tells us how patients can take a major step toward declaring their own independence from a hostile healthcare system - by taking charge of their own medical records. Great advice for any patient.

Standing Up To Powerful Authorities

Dr. Mintz takes on the all-powerful popular media in telling us the truth about the 8 drugs that doctors wouldn’t take. It is very popular to bash the drug companies these days, and accordingly, any negative news about (expensive) new drugs is invariably hyped far beyond any objectivity. DrRich would likely say that this behavior is just another example of covert rationing. But Dr. Mintz more usefully provides the objective truth about these “never drugs.” Perhaps, as a follow-up, he should write about the 8 sources of medical news that doctors (at least the smart ones) wouldn’t read.

JunkMD over at Progress Notes sounds like he’s just about ready to tell the feds what they can do with their latest pay cut. In They Just Don’t Get It, he is fed up both with his Medicare-age Senators and with fellow citizens who expect him to just sit there and take it. Maybe, he allows, it’s time to consider retainer medicine. “Opponents of this model wonder who will see the patients who can’t afford a retainer physician. Well, if none of us are in business, it won’t matter.” That sounds about right to DrRich.

DrRich his own self offers an alternative (and most uplifting) explanation for the fact that doctors apparently owe the IRS multi-millions of dollars in unpaid taxes. Rather than merely being tax cheats, perhaps these physicians are emulating their forebears who nobly defied oppressive Acts of Parliament by throwing tea into Boston harbor. But then again, perhaps not.

The Freedom From Misinformation Act

Dean Moyer of The Back Pain Blog helps one reader declare her independence from misinformation by answering the question Can Herniated Discs Really Heal?

Dr. Paul Auerbach at Medicine for the Outdoors tells those who are exposed to the smoke from wildfires (now raging in California) how to stay healthy. Being aware of oncoming threats in this case is a bit more complicated than “one if by land, two if by sea,” but is no less important.

When DrRich was a medical student, the only decent doctor show on TV was Marcus Welby, MD - a series that was heavy on personal interaction but weak on medical information. So cracking the books was the only good option for learning a little medicine. Today, medical students have many more options. Monash medical student, for instance, is fighting misinformation (his and ours) by reviewing episodes of House.

David Harlow of HealthBlawg reports on the launch of the Massachusetts eHealth Collaborative’s latest Health Information Exchange (HIE). An HIE is more about interdependence than independence, but then, our Founders also banded together (vowing to hang together so as not to hang separately), in their struggle for autonomy.

And Dr Penna reports on new information on Genetic Risk Factors for Alzheimer’s Disease. If you decide to get the test, don’t tell the government or United HealthGroup.

The Obligations of the Individual in a Free Society

Marshall, the Episcopal Chaplain at the Bedside, reminds us in Returning to those Hard Conversations that doctors caring for the terminally ill should more often just say the plain truth, even when it’s painful (for the doctors) to do so.

Dr. Val and the Voice of Reason informs us that it’s plain to both the Surgeon General and to any beat cop that “most people just don’t know what it means to be a good citizen anymore.” Read her plain-spoken interview with Sgt. Zlotkus here, then go do the right thing.

Tories

Some, when a growing conflict reaches the point of no return, will always side with the more powerful disputant. In the Colorado Health Insurance Insider, Louise writes about why doctors are unhappy, and postulates that as a result many physicians now say they are in favor of universal, single-payer (i.e., government) healthcare. DrRich simply notes that after the American Revolution, thousands of Americans who had favored continued rule by the King moved to Canada and got what they desired; and finds it interesting that today’s Americans who want the sovereign power to take over healthcare could do exactly the same thing (if they were to lose the “healthcare wars,” as unlikely as it now may seem), and with precisely the same result.

Am Ang Zhang of The Cockroach Catcher blog tells us about the systematic abuse of the diagnosis of Post Traumatic Stress Disorder by “an alliance of antiwar psychiatrists, VA hospital administrators, and patients who never saw combat or even Vietnam service but found that reciting the PTSD symptoms would result in the awarding of disability payments.” Read about it in PTSD: Diagnosis du Jour. Even John Adams has an opinion about this one.

Picnic Advice, or Don’t Be Stupid

RLBates of Suture For a Living wants to make sure we have a happy 4th. She posts again this year on fireworks safety - a matter whose importance she, a plastic surgeon, unfortunately knows all about.

The Samurai Radiologist at Not Totally Rad offers advice on keeping kids from ingesting foreign objects in Coming Soon to a Child’s Stomach Near You. SR helpfully reports on a missive he received from a concerned parent who is dismayed by the existence of such a thing as Kellogg’s Lego Fruit-Flavoured Snacks: “I just spent the first three years of my son’s life trying to get him not to eat blocks, and now you’re telling him they taste like [fornicating] strawberries. Thanks a lot assholes.” Picnic advice like this you can’t get just anywhere.

What Doesn’t Kill You Will Make You Stronger

Americans have learned repeatedly that adversity produces strength. So, if the rising prices of food have you down, Walter, at Highlight Health, urges you to be of good cheer! In The Upside of High Food Prices he describes how more people are eating local produce - and eating healthier. He neglects to point out (though DrRich will kindly take up the slack) the other problem caused by cheap food that is now being mitigated. We refer, obviously, to the fact that cheap food is the chief source of what has become the latest scourge-of-society: obesity.

Service and Sacrifice

Fighting for what you believe in is always costly, and the cost is never more apparent than in Healthline’s posting on Suicides in US Troops. If you know a serviceman or servicewoman this holiday, let them know how much we all love them and value their service and sacrifice.

The Most Important Aspect of Any Holiday

Bongi at other things amanzi offers us the sad and most affecting story of little k. On this holiday - or any holiday - the best lessen we can take away from k’s story is to gather around us those we love, give them a hug, then count our blessings and thank God for every one of them.

Next Week’s Grand Rounds

Next week Grand Rounds will be hosted by The Blog that Ate Manhattan.

Posted in Uncategorized | 15 Comments »

Never Events? Never Mind

April 18th, 2008 by DrRich

Medicare’s newfound passion for quality has found yet another avenue of expression.

A year ago the Centers for Medicare and Medicaid Services (CMS) announced it would no longer pay for the treatment of certain medical conditions that occur after patients have been admitted to the hospital. These conditions were:

* Bed-sores
* Two kinds of catheter-associated infections
* Air embolism
* Mediastinitis after coronary bypass surgery
* Giving patients the wrong blood type
* Leaving objects inside surgery patients
* In-hospital falls

Now, according to the Wall Street Journal, CMS has proposed adding several new conditions to this list, to wit:

* Surgical site infections following certain elective procedures
* Legionnaires’ disease
* Extreme blood sugar derangement
* A collapse of the lung resulting from medical treatment
* Delirium
* Ventilator-associated pneumonia
* Deep vein thrombosis/Pulmonary Embolism
* Staph infection in the bloodstream
* Disease associated with Clostridium difficile infection

Several commentators admired by DrRich have blogged on the advisability of declaring these particular conditions to be “never events.” All agree that while certain of them clearly should never be permitted to happen (e.g., leaving claw hammers inside a patient’s abdomen, or transfusing the wrong blood), certain other ones are going to continue happening to some patients no matter how high the quality of the institution and the medical professionals. (DrRich particularly recommends the Happy Hospitalist’s cogent and entertaining analysis of the matter.)

Because this topic has been so well-covered, DrRich does not need to comment any further on the unfairness of insisting that doctors prevent every single instance of conditions that are often not particularly preventable; or on the fact that insurance companies (as they always do) will soon follow Medicare’s lead and also refuse to pay for these “never events;” or that hungry attorneys will now begin suing doctors and hospitals for unavoidable complications because those complications have been federally designated as avoidable; or even the fact that, having so deftly expanded the horizons of what can be considered a “never event,” the feds have cleared the path for defining virtually any medical condition they choose as a “never event.” (As a case in point, the feds’ own guidelines on preventing delirium, referred to in their own “fact sheet” that purports to justify the expanded list of “never events,” admit that there are no effective guidelines for reliably preventing delirium.)

There’s also no point in complaining publicly about this expanded list of “never events,” since the public is foresquare behind the notion that no medical complications should ever occur and if they do it is somebody’s fault, and equally behind the notion that the feds can squeeze quality into the system just by demanding it to be so. Therefore, any doctors who complain about these new, tough quality measures will reveal themselves to be both anti-quality and low-quality doctors.

Rather, DrRich will refer back to the true mission of this blog, and simply explain to his readers how this new “never event” strategy furthers the true mission of Medicare and the insurers, which is to say, covert rationing.

For Medicare and the insurers are like closet narcotics addicts - while smiling their pasty smiles and assuring us that each and every one of their new initiatives are only concerned with quality and nothing else, the whole time, with every ounce of their being, they are inventing ways to manipulate, deceive and twist each and every opportunity into some means of scoring another covert-rationing “hit.” Consequently, we cannot go wrong if we ask, each time we see some new program ostensibly aimed at quality improvement: Where’s the rationing?

One might think the rationing in this case is easy to spot. After all, if the feds stop paying for “never events” that actually cannot be avoided, they will save dollars right up front simply by refusing to pay for services rendered. But Medicare itself has estimated that its up-front annual savings from its original list of “never events” would be only about $20 million. And that seems hardly worth the effort.

The real savings will come from a place far more sinister than that. The “never events” initiative - just as the feds tell us - is aimed at changing physicians’ behavior. But quite predictably, that behavioral change will not be in the arena of quality improvement (since no amount of quality improvement can stop “never events” that are inevitable). Rather, the behavioral change will be in the arena of risk avoidance.

While it is unlikely that doctors will ever refuse to care for high-risk patients who are experiencing genuine medical emergencies, it is quite likely they will stop recommending elective medical therapy for high-risk patients. Patients who seem particularly prone to infection, bed sores, falls, blood sugar abnormalities, blood clots, delirium, or who seem likely to need intravenous antibiotics (which predispose to C. difficile) will be particularly targeted. Roughly speaking, these patients will include diabetics, the elderly, anyone with a clotting abnormality or a history of blood clots, the obese, people with immune disorders, and the chronically ill.

Doctors, of course, have always computed a risk/benefit analysis before offering elective services (such as hip replacement, coronary artery bypass grafting, back surgery, gall bladder surgery, anti-obesity surgery, etc.) to such patients. The increased risk of complications these patients face always has factored into such calculations, and into the doctor’s ultimate recommendation.

But now, the “risk” part of the risk/benefit analysis will include two important new risks, and this time they are risks to the doctor herself (and her institution): 1) If any of these complications occur, no payment will be made for the (often very expensive) treatment the complication will require; and 2) If a complication occurs, another “never event” will be tabulated in the federal database next to the doctor’s (and the hospital’s) name, which will inevitably show up in a public report card.

Lest anyone think that doctors would not really stop recommending clinically indicated care to patients just because of the personal risk it would entail, remember that it’s already happened, and is well documented. The government and the insurance companies have already conducted that experiment; it’s been completed, the results have been tabulated, reported, and duly noted. It turns out that doctors, like most other people, respond quite logically to negative incentives.

CMS knows exactly what it’s doing here.

Posted in General Rationing Issues | 5 Comments »

How to Think About the Obesity Dividend

February 10th, 2008 by DrRich

An article published last week in the Public Library of Science Medicine Journal has created tremendous buzz in the media and the blogosphere. This article compared the lifetime cost of healthcare (beginning at age 20) for obese individuals and for smokers to the lifetime cost for non-smokers who maintained a healthy weight. Naturally, the study concludes that the healthy individuals can expect to live longer than the obese and the smokers (84 years vs. 80 and 77 years, respectively). However, the healthy young people will consume $400,000 in lifetime healthcare costs, vs. only $365,000 for fat people and $321,000 for smokers. Therefore, healthy people, over their lifetime, are a bigger drain on the healthcare system than the obese and the smokers.

The reason this study has attracted so much attention is that it appears to fly in the face of conventional wisdom, which considers it axiomatic that our obesity epidemic is one of the major threats to the stability of our healthcare system. (Interestingly, relatively little of the commentary has had to do with the cost savings the study attributes to smokers. Not only are smokers less expensive to the healthcare system than even the obese, they also die substantially younger - and thus burn through fewer Social Security dollars. When you add to that the stiff tobacco tax smokers pay throughout their entire lives, one might argue that not only are smokers cheaper than healthy people, they may actually constitute a societal profit center. Apparently we have already internalized the inherent benefits to society provided by smokers, however, judging from the relative silence toward this aspect of the study.)

The evil of obesity has become a touchstone. Consider the evidence: All three remaining viable presidential candidates have asserted that it’s the obesity epidemic which is largely responsible for draining our healthcare coffers. (One assumes that the formerly-obese Gov. Huckabee, though less viable as a candidate, agrees with this assertion. DrRich cannot begin to speculate on what Dr. Paul’s obesity platform might look like.) Ms. Clinton, as usual, is perhaps the most straightforward in setting out her feelings on this point of healthcare: According to her website, “About 30% of the rise in health care spending is linked to the doubling of obesity among adults over the past 20 years. Had the prevalence of obesity remained the same today as it was in 1987, we would spend 10 percent less per person - approximately $200 billion - on health care today.”

Even more tellingly, it has become acceptable even in polite circles to openly discriminate against, if not overtly disdain and humiliate, the obese. Fat people are now expected to pay for two seats on airplanes. Mississippi is considering legislation to prevent the obese from eating in restaurants. And in Britain, whose healthcare system has been held up as a model for Americans, doctors themselves are saying that obese patients should be barred from receiving medical services. (Though, in defense of his colleagues, DrRich wishes to point out that these same physician-humanitarians are also calling for the withholding of medical care from the elderly and smokers - so in truth they are not being unusually unfair to the fat.)

So in light of this carefully cultivated scorn for the obese - who are clearly being groomed as a prototype, as a group whose characteristics (ostensibly, their lack of self-discipline, or their sloth, or their selfishness, or whatever other characteristics we can attribute to them that makes them seem different from “us”), justify special treatment in order to serve the overriding good of the whole - in light of this, what are we to do with this new study which says that obesity saves money for the healthcare system? Do we reverse course, and embrace the obesity dividend? Do we encourage supersizing, and, far from refusing to serve them, offer the overweight free second portions? Do we give them deeply discounted heavy-duty suspensions? Better yet, do we give away free Marlboro starter packs to the fat? (Just think how much money we’d save with obese smokers.)

Thankfully, no.

DrRich has pointed out innumerable times the absurdities we find ourselves promoting when the chief purpose of the healthcare system becomes avoiding costs rather than maximizing health, that is, when its chief job is covert rationing. (The Happy Hospitalist has provided us with an enlightening riff on this topic as well.) It is therefore gratifying to say that this is one of those cases where we don’t have to engage in such absurdities. Let’s be plain about it: We don’t need to reevaluate our current vilification of obesity (and smoking) just because people who have these conditions may save us money in the long term.

The reason? We don’t care about the long term.

Who cares that in 60 years, today’s healthy 20-year-olds are going to cost us a lot of money? They’re largely free to the healthcare system for at least several decades. In contrast, the obese and the smokers, what with their chronic diabetes, heart disease, kidney disease, joint replacements, strokes, lung disease, etc., etc., are going to cost us money each year, starting today.

If we actually cared about the long term, we’d be doing something about the Social Security and Medicare entitlements we’ve already signed up for, which in a little more than 20 years will require confiscating more than 50% of each American paycheck, just in payroll deductions. (Never mind income tax.) Heck, just looking at their pay stubs will probably cause most of today’s healthy 20-year-olds to die of apoplexy by the time they’re 40. In any case, the entitlements we’re obligated to provide will threaten societal disintegration long before today’s healthy young adults ever need elder care. Consoling ourselves with the idea of projected long-term savings is like consoling ourselves with the idea of beautiful spring alpine flowers when we’re directly in the path of an onrushing avalanche. Projected long-term savings are completely irrelevant.

The obesity dividend is just smoke, and can be safely ignored. For the greater good of our social welfare, we’re far better off doing what we’re doing today - castigating and humiliating the obese into right actions, and if that fails, then simply following the example provided by one of the civilized healthcare systems we’re encouraged to use as a model, and discriminating against them when they need healthcare. Once we’ve established this useful prototype, we can apply it to whatever additional groups we can identify as targets of our collective indignation.

Whatever it takes to avoid confronting the rationing issue head on.

Posted in General Rationing Issues | 8 Comments »