Limiting Crestor
November 18th, 2008 by DrRich
In a previous post, DrRich wrote about the JUPITER trial, the controversial clinical trial (so controversial that even Stephen Colbert did a riff on it) which showed that the (extraordinarily expensive) statin drug Crestor significantly and substantially reduced the risk of heart attack, stroke and death in people who had normal cholesterol but high CRP levels.
While many prominent medical figures have defended the JUPITER trial as being well-designed, well-conducted, and productive of very compelling results, and have therefore concluded that doctors should take this information into account when treating their patients, and have even called for the guidelines on statin therapy to be formally revisited, other prominent figures tell us that we must dismiss such ridiculous opinions as coming from mere shills and puppets for the pharmaceutical industry.
But, as DrRich showed in his earlier posting with his characteristic thoroughness and impeccable reasoning, those who wish to dispel the notion that Crestor should be ground up and mixed into everyone’s toothpaste are taking the wrong tact when they simply try to make the results of the JUPITER trial go away.
Sure, we might all wish the sponsors and investigators had also studied one of the cheap statins in this trial, or had included an arm within the trial that would have told us whether doing expensive CRP testing was really necessary, but we cannot be legitimately angry with them for doing what they did. After all, it’s the system we’ve purposely laid out for the drug companies that requires them to invest tens of millions of dollars in trials like this before they’re permitted to sell their products. So we can scarcely criticize them when they comply with the prescribed system by designing their trials to test only their own products. (Let those other companies run their own trials, at their own expense.)
The sad fact is, as much as we may not like the study’s design, there is no denying that when you give Crestor to people like the ones enrolled in the Jupiter trial, their clinical outcomes will be significantly improved.
So let’s just cut to the chase and admit that despite the fact that we would spare nearly 35,000 JUPITER-like Americans a heart attack, stroke or death each year by giving several million of them Crestor, we just don’t want to pay the $7 billion per annum it would cost us to do so. (Heck, it would be only half as expensive to send each of the affected spouses a condolence payment of $100,000, and who’s to say many of them wouldn’t appreciate that consolation more than they would appreciate receiving a free lifetime supply of Crestor for those lumps on their couches?)
The question, then, boils down to this: Given that we have no intention whatsoever of buying our fellow Americans all that Crestor, in the face of the results of the JUPITER trial how are we going to justify that intention, to ourselves and to others?
DrRich has spent a good bit of time reading the various arguments experts (and others) have advanced to justify not purchasing the prodigious amounts of Crestor which the JUPITER trial was designed to coerce us into purchasing. He believes these arguments can be summarized into two general categories.
Why we should limit Crestor: Argument 1.
The first general argument is the notion that in the JUPITER trial, the benefit imparted by Crestor really didn’t do that much good after all, so bothering about placing millions of people on Crestor just doesn’t make sense. There’s just no need to consider the matter any further.
DrRich, of course, answered this argument in his previous posting. Simply put, the argument is statistically spurious. It requires ignoring the actual statistical analysis presented in the JUPITER paper itself, and instead considering only the data as it was misrepresented in (or perhaps misinterpreted from ) the accompanying editorial. And, even if you allow the misrepresented data, the magnitude of benefit imparted by Crestor in this population is (considering the sheer number of Americans who would be spared a cardiovascular catastrophe if they took the stuff) still quite substantial.
In the days since publishing his last article, DrRich has done a bit of research to see what the magnitude of benefit is said to be for a well-known comparable therapy, one that is not only widely used in modern medicine, but is also celebrated as perhaps the most important preventative medical therapy yet devised - the treatment of hypertension. Americans are all urged to have their blood pressure checked beginning at a very young age, and if they have hypertension they are urged to have it treated aggressively. Scores of clinical trials have been done looking at the benefits of treating hypertension, and DrRich knows of no physicians, professional organizations, or even nihilistic consumer groups (such as exist to castigate statins) who say that treating hypertension is not worth the effort.
As it turns out, aggressively treating moderate hypertension (diastolic blood pressures of 90 - 100 mmHg) for five years yields a relative reduction in cardiovascular events (heart attack and stroke) of between 16% - 40%, and an “absolute” reduction in risk of 0.7% - 1.3%. Well, what do you know? That’s pretty much the same as the relative and absolute risk reductions resulting from Crestor (even allowing the unfortunately-presented summary of data from the JUPITER editorial), except the benefits with Crestor are accrued after only two years.
If we’re going to argue that using Crestor in JUPITER-like patients just doesn’t do enough good to bother with, then to be consistent we’ll have to also abandon all the anti-hypertension hype we’ve all been promulgating for 30 years. (DrRich uses the word “hype” advisedly. By the same criteria of data analysis being urged upon us by critics of the JUPITER trial, the massive public health campaign on hypertension we’ve been so deeply engaged in - and paying for - for so many years can only be considered hype.)
If we can save a bundle by withholding Crestor, just think of how much we can save by withholding the treatment of hypertension.
Why we should limit Crestor: Argument 2.
The second general argument is that we shouldn’t pay for Crestor because individuals could achieve similar benefits “simply” by choosing to engage in healthier lifestyles. All they need to do is stop smoking, exercise vigorously for 30 - 60 minutes per day, attain an ideal weight, eat an exemplary diet, and have their hypertension, cholesterol levels, and diabetes optimally treated. Because people have it in their power to control these important factors, they should do so, and we should not discourage them from doing so by providing them with a pill to achieve similar benefits. Providing them with such a pill (apparently) would be fiscally irresponsible, morally irresponsible, or both.
DrRich finds that this is not a completely illegitimate argument. People should take responsibility for their own health, and perhaps should not expect society to bail them out when they develop one degenerative disease or another because their lifestyles are not completely exemplary.
However, if we are to make this the official policy of our healthcare system, then we certainly would not stop with Crestor for elevated CRP levels. To be consistent (and the whole point of “tough love” is to be consistent), we would also need to withdraw therapy for most people with hypertension, type II diabetes, stroke, heart disease, metabolic syndrome, lung diseases, liver diseases, sexually transmitted diseases, osteoporosis, trauma, and numerous other conditions often associated with lifestyle choices.
Talk about saving ourselves a bundle.
Here is the bottom line as DrRich sees it: Any healthcare (or political) policy that relies on a fundamental change in human nature is doomed to failure. (If this were not universally true, then Communism would have worked out just great in one place or another.) We can encourage and educate people about their lifestyle choices. We can even incent them to make good choices. But we can’t have a realistic healthcare system that insists or relies upon every person making those good individual choices.
So, while refusing to purchase medical services for people who could help themselves by choosing healthy lifestyles is not a completely illegitimate approach, it is an approach that we need to consider very carefully given its certain negative outcome. And for us to attempt to force this approach not generally, but instead to one specific medical condition or one specific therapy, and for completely arbitrary reasons, is perhaps feasible but is hardly morally or logically defensible.
Besides, the JUPITER investigators inform us that Crestor worked just as well in patients who apparently did follow reasonable lifestyle recommendations. So we might end up having to give the stuff to people whether or not they live the way we insist they live.
The right approach
It is not wrong for us to balk at spending $7 billion each year on Crestor. We would be crazy not to balk at it. It’s just that neither general argument advanced by the opponents of JUPITER seems very satisfactory, and in fact, to DrRich they seem completely bereft of merit.
It is likely not appropriate for us to spend all that money on Crestor for the amount of benefit that we would stand to gain. But it’s not because there isn’t substantial benefit to be had, nor is it because people just need to take better care of themselves before asking us for any healthcare.
What we’re really asking ourselves is whether Crestor is one of those healthcare products that ought to be withheld in response to the absolute unavoidability of rationing. And there’s simply no good answer to this question as long as we insist on pretending that rationing is not necessary and is not already occurring, that is, as long as we insist on accomplishing the unavoidable rationing covertly. The abandonment of rational discourse and the enthusiastic adoption of self-delusion are inherent features of covert rationing, and both are on obvious display here.
An open, transparent system of healthcare rationing would allow us to objectively assess the merits and the cost of Crestor in patients with elevated CRP levels, and to compare those merits and costs to other, similar medical services - the treatment of hypertension, for instance. With such a system we could make disposition on the use of Crestor quickly and objectively, without the twists of logic and without appeals to Platonic ideals of human nature, as we’re seeing today. Perhaps even better, the transparency of such a system would finally focus companies away from developing products they believe they can coerce us, through the use of cleverly designed randomized clinical trials, into paying for. An open system of rationing would, for the first time, focus the innovators of medical technology on developing products that reduce healthcare costs. Today, under covert rationing, technology is instead employed - with great creativity and incredible efficiency - to produce a steady stream of high-margin products that offer only incremental benefits.
Calling for the adoption of a system of equitable, objective open rationing is relatively easy. Designing a system for doing so - not so much. So it would not be fair or reasonable for DrRich to insist on a system of open rationing without describing how such a thing could be accomplished. And so, in the interest of fairness and reasonableness, he reminds his readers that he has attempted to do so both in his book and on his other website. Other, smarter people could doubtless come up with even better systems. It would be difficult, though, to come up with a reasonable system of open rationing that is not less destructive than the system of covert rationing we’re engaged in today.
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.
On Respecting Nurses
November 10th, 2008 by DrRich
DrRich commends to his readers Dr. Val’s new blog, Getting Better with Dr. Val. Val is taking the good work she did on her former site at Revolution Health, and lifting it to new heights.
In particular, DrRich suggests you make yourself a nice cup of tea and listen to her 30 minute podcast on what’s ailing American nurses today. This is a patented Dr.Val well-known-people interview, this time with three eminent blogging nurses, all of whom are very thoughtful and very articulate about their profession.
DrRich has been a great admirer of nurses for 35 years, ever since a head nurse went out of her way to (diplomatically) save DrRich’s intern *ss when he was about to do something stupid to a patient. DrRich worked very closely with colleagues who were nurses during his entire clinical career, and considers many of these people to be the finest medical professionals he has ever known. More recently, DrRich has come to admire and respect the nursing profession as possibly the last bastion of real medical ethics. (The physicians’ new ethical precepts have largely thrown patients under the bus. Nurses haven’t done that yet.)
Much of what Gina (Code Blog), Strong One (My Strong Medicine), and Mother Jones (Nurse Ratched’s Place) have to say about the nursing profession is not all that surprising. That nurses are often disrespected and stereotyped by god-like doctors and poorly-informed patients is, sadly, an old story. But DrRich is struck by two things in Val’s podcast.
First is that there is a long, long waiting list for entrance to nursing school. DrRich had no idea. He finds it uplifting that so many young Americans are lining up to enter this still-noble profession, especially at a time when nurses are so needed. It seems likely that at least some of this enthusiasm reflects the fact (and it is a fact) that the nursing profession is entering an era where the stereotypes and the disrespect seem ready to be torn down. While he has no special insight into the matter, DrRich finds it very likely that nursing school slots will be rapidly expanded (and nursing instructors will be adequately rewarded to staff these new slots), simply because there will be little other choice for our healthcare system.
Second, it is striking that nurses seem to have figured out already that taking over primary care medicine from the rapidly-dwindling primary care physicians is a losing proposition. They are avoiding the opportunity in droves.
That, if nothing else, should tell us how smart nurses really are.
Thanks to a) the growing nursing shortage, b) the inability to accommodate all the people who want to enter nursing, and c) the fact that those who have made it into the nursing profession are very smart people with “disturbingly” high ethical standards, we find that the healthcare system will soon need to re-evaluate its strategy in regard to primary care medicine.
Our healthcare system has taken exquisite pains to make primary care medicine an untenable proposition for American doctors. Not only is their pay (which, by the way, is determined the same way it was determined for workers in the old Soviet collectives) low, but also their autonomy as physicians has been wrecked by arbitrary guidelines; their clinical activities are closely monitored and second-guessed by stone-witted bureaucrats; they have been limited to 7.5 minutes per “patient encounter” and the stuff they must accomplish during those 7.5 minutes is determined by Pay for Performance checklists; they have been charged with operating flawlessly under a system of hundreds of thousands of pages of federal rules, regulations and guidelines whose meaning is not merely unclear, but is fundamentally indeterminate, like Schrodinger’s cat, and (also like Schrodinger’s cat) which remains fundamentally unknowable until the “box is opened” through criminal prosecution (whereupon doctors who had been practicing in good faith have at least a 50- 50 chance of learning that they are actually professionally dead); and finally, they have been charged with the duty of covertly rationing their patients’ healthcare at the bedside by the healthcare bureaucracy, by the United States Supreme Court, and by the new-age ethical precepts of their own profession.
The healthcare system has done all this precisely to drive physicians out of the primary care business, for the explicit purpose of opening the primary-care doors to a profession it believes is more tractable than physicians - namely, the nurses. The healthcare system sees nurses as professionals who (once they are duly certified in primary care medicine through respected testing organizations), will have just enough training to diagnose and treat the average patient (i.e., the ones with high blood, low blood, fat blood and sugar), and who will cheerfully, unquestioningly follow whatever guidelines are handed down to them from on high. And they will do all this for less pay and with less lip than the now-obsolete physician PCPs. These new practitioners of primary care medicine will be a perfect fit.
Except for one thing. The nurses want no part of it.
The nurses interviewed by Dr. Val speak of the relatively low pay primary care nursing practitioners receive, especially compared to what specialist nurses can make working in hospitals. They also seem to understand the real downsides of primary care nursing. There is an inherent lack of respect toward primary care in the U.S., which is clearly expressed by both specialist doctors and patients, no matter who is delivering it. Primary care nurses will also be saddled with the same guidelines, intrusive bureaucratic oversight, time limits, threats of a federal fraud rap if they misinterpret a rule, and the same bedside rationing expectations that have ruined the careers of primary care doctors. They will be accountable for their patients 24/7, and will be subject to malpractice suits beyond most nurses’ imagining. And the fact that primary care practitioners have been maneuvered into owing their chief allegiance to third party payers instead of to patients will be perhaps even more insulting to nurses than it turned out to be for doctors.
The notion that nurses will jump at this opportunity is absurd. That the healthcare system appears to blithely assume they will happily do so is perhaps the greatest disrespect being perpetrated on the nursing profession today.
For what it’s worth, DrRich supports the nursing profession in saying “no” to the healthcare bureaucracy. They should not engage in primary care until they can do so without compromising their principles and their commitment to patients. He prays they will stick to their strong ethical ideals, and keep their patients first, and tell the system that if they want to treat patients like widgets, then go find somebody else to do it. Had doctors given this answer the medical profession would not be in such sad shape today.
Nurses may not magically garner instant respect from doctors and patients if they take this stand, but they’ll at least maintain their own self-respect. And anyone who doesn’t think this is the most important kind of respect, just ask someone who has lost theirs - you might want to start with some of the doctors.
Why Conservatives Shouldn’t Sweat Our New Right to Healthcare
October 27th, 2008 by DrRich
In response to a couple of recent posts (here and here) defending the declaration by President-Nearly-Elect Obama that healthcare is a right, several readers have offered comments indicating that simply declaring healthcare to be a right is not very useful, unless you also clearly say what you mean by “healthcare.”
This is indeed the question. Exactly how much healthcare are you entitled to if you have a right to healthcare? Do you have a right to certain specified healthcare services, to a certain dollar amount of healthcare per year or per lifetime, to whatever healthcare it takes to achieve perfect health, or to some other limit or non-limit?
The question of limits (whether we should have them or not, and what should they be) has been a central theme of this blog and of DrRich’s book. To reiterate the fundamental problem: 1) In America we believe that it is wrong to limit healthcare in any way, that everyone is entitled to the very best healthcare, that any bit of healthcare that offers even a small potential of benefit should be provided, and that death itself is merely a manifestation of insufficient research (or actionable incompetence, or systematic discrimination against the unwealthy, or corporate greed). 2) But against that closely held belief, we must balance the unremitting law of economics which tells us that there is simply not enough money in the known universe to buy all the healthcare that might potentially offer some small amount of benefit to every person. Healthcare spending has to be limited, or it will become a fiscal black hole.*
Our insistence upon simultaneously balancing these two utterly incompatible factors (the rock-solid belief that there are and can be no limits vs. the unalterable law that limits are unavoidable) requires us to do the necessary rationing of our healthcare (that is, withholding at least some potentially useful healthcare from at least some of the people who might benefit from it) covertly.
So, our entire healthcare system, from all three branches of the government, to health insurance companies, to hospitals, to doctors, to individual Americans (at least when they themselves are not actively patients), are fully and extravagantly and enthusiastically engaged in covert rationing, by a thousand different mechanisms, some of which have been chronicled here.
One reason DrRich is not as reluctant as some to accede to the notion that healthcare is a right is that such a declaration might, at last, move us closer to the day when we will actually be forced to engage in a public discussion of what we mean by healthcare; that is, will move us closer to deciding what should be the limits of healthcare.
Consider: When we have tens of millions of uninsured Americans who don’t have ready access to regular and routine healthcare, then it’s relatively easy to pretend that “healthcare” should include everything we might want it to include. By using the uninsured as a huge fiscal safety valve for our dysfunctional healthcare system - a valve that can be opened, as needed, to increase the number of people ineligible to consume routine healthcare - we can shore up the fiction that “healthcare” ought to have no limits. (Indeed, steadily increasing the number of uninsured Americans has become perhaps our most effective mechanism of covert rationing). This simple expediency alone goes a long way toward enabling us to avoid having to consider or discuss limits.
But once healthcare becomes a right, then presumably those (currently) 47 million Americans will suddenly have a claim to equal access to whatever it turns out we mean by healthcare. The severe fiscal stress produced by this sudden influx of entitled Americans will likely force us, finally, to explicitly define the limits of what we should expect from our healthcare system.
Defining those limits will be extraordinarily painful, and will very probably traumatize our social structure. However, the process is necessary, because if we fail to set those limits the resulting fiscal tsunami - which will utterly dwarf the economic trifle we’re dealing with today as a result of the mortgage crisis - will leave us without any social structure to traumatize.
If declaring healthcare to be a right causes us to engage in this painful exercise now, before it is too late, then DrRich is in favor of it. Even American conservatives ought to be thanking Mr. Obama for doing his bit to bring the issue to a head.
*In contrast, our national, de facto declared right to affordable mortgages for everyone, no matter one’s credit risk, will result in some finite, limited amount of national debt, since every home has some finite, limited value. Even if the final cost to society is very, very large, a national right to home ownership in fact results in a fiscal obligation for society that is limited and quantifiable, and in one way or another is therefore ultimately manageable.
Anyone who insists that there must also be similar inherent limits on what we can spend on healthcare should simply consider that once we have artificial hearts, artificial kidneys, artificial livers, and can indefinitely preserve brain function sufficient to, perhaps, plug aged-but-medically-preserved bodies into some sort of virtual reality where they can frolic like virtual children forever (DrRich does not really know what medical immortality will turn out to look like, just that it is the ultimate goal of medical research, as any real American can tell you), then the amount of money we can spend on any given individual’s healthcare becomes limitless. It is indeed nearly limitless with just the stuff we have today.
Ethicist-Assisted Suicide
September 8th, 2008 by DrRich
In a previous post, DrRich attempted to satirize the lame attempts of certain healthcare payers to “inform” certain of their covered lives that, among all the wonderful options available to them under their truly comprehensive health plans, the medical service of physician-assisted suicide would be compassionately offered and cheerfully paid for. (Note to the policy experts who direct politically-acceptable healthcare terminology: Is the term “covered lives” even appropriate any more when we’re finally dabbling in the realm of covered deaths?) DrRich even offered, thoughtfully as usual, some free though invaluable advice to payers on how they ought to go about marketing assisted suicide as a cost-saving strategy, and to do so in a far more sensitive and less ham-fisted way than they have managed so far.*
If the mark of good satire is that at least some readers will have difficulty discerning whether the satirist is serious or not, then DrRich is feeling genuinely Jonathan Swiftian today. For, while David Hamilton of BNET seems to get the concept of satire, some of his readers (”I can’t believe what I just read. This is sick.”) do not. This is not the first time DrRich has made unfortunate impressions upon readers through his (possibly inept) use of irony. It will certainly not be the last.
But assisted suicide being such an important and ethically charged topic, DrRich feels obligated to clear things up once and for all. So what follows is DrRich’s honest assessment of the advisability of physician-assisted suicide, in which he will attempt to forgo entirely any satire or irony (though he admits to having great trouble in controlling his sarcasm).
DrRich believes that physician-assisted suicide is a very, very bad idea. He has two major reasons for this belief. On a purely practical realm, embracing and systematizing physician-assisted suicide under any healthcare system that is actively engaged in rationing (whether overtly or covertly) will necessarily lead to horrific abuses of the practice. DrRich attempted to touch upon some of these entirely predictable outcomes of such a policy in his previous post. For other negative outcomes that are likely or at least possible, you can either use your imagination, or read the history of Europe in the 20th century.
His second objection to physician-assisted suicide is based on ethics. DrRich admits to being on shaky ground here because: a) he is not formally trained in ethics, and b) it appears for all the world that formally trained ethicists have universally concluded that physician-assisted suicide is perfectly OK in every way.
Debating with modern medical ethicists, at least if you are merely such a one as DrRich, is a losing proposition. This is not because ethicists are intellectually (or even ethically) superior, but rather because they are adept in couching their arguments in arcane twists of logic and webs of jargon that make their arguments difficult if not impossible for the uninitiated to follow. This technique, of course, places laypeople like DrRich in the position of having to accept the ethical bottom line without really understanding how the bottom line was reached. It reduces medical ethicists to a priesthood, and medical ethics to received knowledge.
But DrRich maintains that advancing unintelligible ethical arguments is, well, unethical.
So DrRich will now present his understanding of the chain of logic by which modern ethicists justify physician-assisted suicide - and its close cousin, euthanasia. (If any of you actual ethicists out there object to this analysis, and can explain where DrRich is wrong in clear language, DrRich will be all ears. Otherwise, you can pound salt.)
Point 1: Our society has already decided that the autonomy of the individual patient is the overriding ethical consideration in making end-of-life decisions. We made this determination when we decided that a patient has a right to refuse medical treatment even if that treatment is very likely to save their life. Therefore, we have already firmly decided that passive euthanasia - letting nature take its course - is ethical.
Point 2: There is no ethical distinction between passive euthanasia and active euthanasia. Whether we let death occur by withholding effective medical care, or by actually doing something to help death along a bit, we’re taking an action that hastens death either way. Ethically, both of these actions are equivalent. So, once we decide that individual autonomy is the overriding concern, we must also allow for active euthanasia when a patient wishes it.
Point 3: Once active euthanasia is deemed ethical, there can be no further ethical objection to the lesser act of physician-assisted suicide. If it is ethical for a doctor him/herself to bring on the death of a patient who requests it, there can be no objection to doctors preparing the suicide machine and handing the patient the switch.
The striking thing here (to DrRich, at least) is that in establishing the ethical case for physician-assisted suicide, we necessarily also establish the ethical case for physician-provided euthanasia. Whether the patient says, “Help me to take my own life,” or “Take my life for me,” modern medical ethics supports the physician who replies, “Roll up your sleeve.”
For those who still don’t see a problem, DrRich refers you to the Dutch system, where the rules permit both physician-assisted suicide and active euthanasia for patients who request it, in full accordance with modern medical ethics. Reports on the results of the Dutch system (reports which both sides have used to bolster their respective opinions on either the glories or the travesties of such a system) do point out one striking finding - hundreds of times each year, acts of involuntary euthanasia are occurring. That is, patients are being killed under the Dutch healthcare system at the hands of their doctors, without their explicit permission. All these patients, it is claimed, are being euthanized for entirely humane reasons.
What do our friends the medical ethicists have to say about involuntary euthanasia? Well, it turns out that it’s OK with many if not most of them. Ethicists don’t like to tell us that their chain of logic doesn’t end with Point 3. But once we make the principle of individual autonomy the overriding consideration in determining end-of-life ethical issues, the same chain of logic takes us directly to Point 4.
Point 4: Since honoring the autonomy of the individual makes voluntary euthanasia available for patients with intractable suffering, it would be unethical to withhold the same benefit from suffering patients who are too incapacitated to give their permission. Their incapacity should not restrict them from a good that is available to capable patients. To fulfill this right, the boon of euthanasia can and must be performed, without the patient’s explicit permission, in incapacitated patients whom “reasonable people” would agree are suffering too much - that is, involuntary euthanasia is also ethical.
This conclusion, of course, leaves us in a place where others (i.e., “reasonable people” like doctors) can decide for an individual what constitutes intractable suffering, and further, can decide when such an individual is simply too incompetent to know that euthanasia is the only thing to do. Some of you, of course (hello, ethicists!) think this is just a fine idea. Most apologists for the Dutch system apparently do, for instance.
DrRich maintains that under a system of covert healthcare rationing, where doctors are under extreme pressure to do the bidding of the third party payers (insurers and the government) who determine their professional viability, and where the payers are under extreme pressure to reduce cost, and have already displayed in numerous ways their willingness to permit suffering and death among their subscribers in order to do so, then opening the door for physician-assisted suicide (let alone physician-administered euthanasia, whether the patient requests it or not), would lead to horrible abuses, and would ultimately serve to undermine our civil society. DrRich is too politically correct to use the “other” N-word, but he will take this opportunity to remind his readers that such a thing has already happened, in what had been perhaps the world’s most cultured and educated society, during the last 100 years.
DrRich believes that the principle of individual autonomy is vitally important, and indeed it is the foundation of American culture. However, no single ethical principle, no matter how important, can be allowed to overrule all other ethical principles in all other circumstances. Ethical principles are often in conflict, creating what is called an ethical dilemma. And (DrRich humbly submits) it is supposed to be the job of ethicists to help us work through those ethical dilemmas, to find the right balance between competing principles, and not simply to declare that no dilemma actually exists, because ethical principle X is the only one we need to pay attention to.
Individual autonomy is critically important, but in no other aspect of our culture do we let it absolutely rule. The autonomy of individuals needs to be checked, and we indeed limit it. The reason we have laws (supposedly) is to make sure that the behavior of individuals who have accrued power (for instance, by accumulating great wealth, by acquiring large weapons, or by becoming heads of state) does not abrogate the rights of other individuals, and to make sure that individuals acting in their own interests do not create too high a cost for our society as a whole. Indeed, most of the political fights we have - between Democrats and Republicans, liberals and conservatives - are to determine where best to place those limits, on individuals and on the collective, to best encourage a robust society that honors individual autonomy but that also encourages reasonably equal opportunity. The main purpose of our public discourse, then, is to find the right balance between the rights and needs of individuals and the rights and needs of society as a whole.
So for ethicists to say, “Individual autonomy is all there is to it, and we have no choice but to follow that principle to wherever it may lead us,” is not only completely irresponsible and dangerous, it also flies in the face of our culture’s history and our everyday experience. The cost to society not only should but must be taken into account as we consider institutionalizing physician-assisted suicide (let alone voluntary or involuntary euthanasia). In DrRich’s opinion, ethicists who argue that we need not consider the cost to society in making end-of-life policy have declared themselves unworthy of the title and they ought to be completely ignored.
The cost to our society of institutionalizing and systematizing physician-assisted suicide, especially while we are still covertly rationing healthcare, would be severe and potentially lethal. We simply should not do it, and we should fight efforts to make it so.
If people want to commit suicide and if medical ethicists insist that assisted suicide is OK, then let the ethicists do the assisting. DrRich has relatively little to say against ethicist-assisted suicide. But, at least as long as covert rationing is the chief operating paradigm of the American healthcare system, for the love of God keep the doctors out of it.
*Despite the clear value of this advice, DrRich still awaits his first “thank you” from Aetna or United HealthGroup or even the Oregon Health Plan. This shows us once again that, unless they’ve paid expensive consultants a few hundred thousand dollars for it, big companies and big bureaucracies are utterly incapable of recognizing even obvious truths, truths that any of their middle managers could usually give them for free.
Taxpayer Support of the Evil Drug Companies
August 25th, 2008 by DrRich
Demonizing the drug companies is a necessary and indispensable strategy under a healthcare system that covertly rations healthcare. Quite simply, it is necessary because drug companies are in the business of developing expensive new products that doctors and sick people will demand for themselves.
If we can paint the pharmaceutical industry as being sufficiently evil and corrupt, then we can justify constraining drug companies so as to limit the introduction of these expensive new products. We can, for instance, build daunting regulatory hurdles or legislate “windfall profits” penalties. Fortunately for us, drug companies are indeed not the most fastidious members of the corporate community, and their actions and methods provide us with many fruitful avenues for demonization.
One such avenue is to show how the corrupt pharmaceutical industry feeds at the trough of the American taxpayer. As an example of this reprehensible behavior, the New York Times has pointed us to the case of Dr. Laszlo Bito and the anti-glaucoma drug Xalatan.
In the early 1980s Dr. Bito, a researcher at
Subsequently, the pharmaceutical giant Pharmacia purchased the rights to Bito’s discovery for a mere $150,000. Based on Bito’s tax-supported work, eventually Pharmacia released the anti-glaucoma eyedrop preparation Xalatan. Xalatan rapidly became a worldwide best-seller, yielding as much as $500 million in sales per year. For their part in this wondrous success story,
Meanwhile American glaucoma sufferers are forced to spend upwards of $50 every six weeks for a tiny vial of the drug, which costs the company only a small fraction of that amount to produce, and whose discovery the glaucoma sufferers paid for with their own tax dollars. And, as if to guild this already brazen injustice, Pharmacia makes Xalatan available in
It seems, the Times points out, that the American taxpayers are the only parties in this little scheme who reap no financial return on their investment. All they got were some expensive eyedrops.
And so, drug-company demonizers would have us conclude, this is a particularly egregious example of how the evil pharmaceutical industry is ripping us off. Not only are the drug companies mercilessly profiteering from sick Americans (which, after all, is their openly-admitted business model), but they are also picking the pocket of every American by using our tax dollars to invent new drugs, then selling those drugs back to us at exorbitant prices. This, one could reasonably argue, is at least as sociopathic as anything the tobacco companies ever did. (The tobacco companies, in contrast, at least had the good graces to eventually stop claiming that they were a major boon to the public health.)
And (we are all supposed to agree), if this reprehensible behavior doesn’t give our government the right to control the prices charged by drug companies, one would be hard pressed to say what does.
To all this, of course, DrRich says, “Bosh.”
DrRich certainly doesn’t want to absolve the pharmaceutical industry of all responsibility for drug prices that seem obviously too high, or for the striking pricing disparities we see between the
There is much not to like about high drug prices, or the fact that people in other countries reap the benefits of American research for far lower prices than Americans do. And it is reasonable for us to seek to address these pricing issues. But as we address certain inequities in drug pricing, we should be careful that in doing so we don’t throw the baby out with the bath water. So if we’re going to alter the arrangement we have with the pharmaceutical industry, let’s be clear on how that arrangement works, and why we set it up in the first place to operate as it now does.
Consider once again the glaucoma drug Xalatan, and consider how Dr. Bito’s discovery was actually used by Pharmacia.
Bito did not discover a finished product. Instead he discovered a new concept for reducing intraocular pressure (that is, for treating glaucoma), and demonstrated that it could be effective - but the specific compound he discovered was not marketable. In fact, it was so highly irritating when applied to the eye that it was simply not suitable for clinical use. Indeed, Bito’s discovery was offered to and rejected by a host of drug companies as being completely infeasible.
When Pharmacia finally agreed to pay for the rights to Bito’s patent, they took on an expensive risk that, some estimated, had less than a 5% chance of achieving success. Pharmacia assumed the difficult task of developing a brand new synthetic molecule that would have all the benefits described by Bito, but at the same time would not have the prohibitive side effects. There was no assurance that such a molecule could be found. Then, they would have to shepherd their new compound through a time-consuming and costly regulatory gauntlet that proves fatal to most new drugs, and pray that it would gain FDA approval. That their efforts were ultimately successful does not diminish the fact that, when they agreed to invest the time, money and opportunity cost to develop Dr. Bito’s discovery, they were taking on a large risk with no assurance of making a profit or even recouping their losses.
Bito’s (tax supported) idea was a promising one, but the challenge of developing that idea into a product that was useful to patients and that could be brought to market was very expensive and highly risky. Pharmacia took on that risk (all of which was borne by its shareholders, and not by taxpayers) only after difficult, internal corporate soul-searching. If not for the prospect of making enormous profits if this risk worked out, the company (like several other drug companies did in this particular instance) certainly would have walked away.
Before 1980, it is likely none of this would have happened. The Bayh-Dole Act of 1980 was passed expressly to encourage the further development of federally financed, university-based basic research. Until then, a large proportion of basic university research was never “translated” into useful medical products. Such translation of basic research was recognized by Congress to benefit society not only by advancing the practice of medicine, but also by stimulating the overall economy. So industry was actively encouraged to take on the risk of developing promising ideas that came out of federally-funded research. And the profit that greeted successful enterprises was designed to be the one thing that would lure industry into taking that risk.
So when the Times “discovers” a company “profiteering” from work done with tax dollars, it should not be a revelation, nor should it be an unmistakable sign that the company is inherently evil or dishonest, nor does the company’s activity in this regard give us the right to arbitrarily restrict its profits. Rather, that’s simply the deal we taxpayers made with the drug industry (through our elected officials). We made this deal because we felt, in the long run, that it would benefit American society, and quite probably, us as individuals. If we want to change that deal now, so be it. It is within our rights to do so.
Without Bayh-Dole, perhaps patients with glaucoma would still be getting surgical therapy and wearing those coke-bottle lenses instead of just using eyedrops. And if we want to put the brakes on such medical advances (in order to prevent unseemly profiteering), we certainly can.
But we shouldn’t vilify the drug companies for taking us up on the deal we offered them.
How to Sell Assisted Suicide
August 10th, 2008 by DrRich
In July, the Oregon Health Plan injudiciously sent a letter to lung-cancer patient Barbara Wagner denying coverage for the expensive chemotherapy her doctor had recommended, and offering instead to cover palliative care “including doctor-assisted suicide.”
The firestorm of outrage this letter triggered (to see the outrage for yourself, simply Google the search terms “Barbara Wagner” and “suicide”) penetrated even the dulled sensibilities of the Oregon insurance executives. One Jim Sellers, a spokesman for the Oregon Health Plan, admitted to ABC News that “the letter to Wagner was a public relations blunder and something the state is ‘working on.’”
DrRich expects that the Oregon Plan executives must feel at least a little blindsided by the general reaction to their ham-fisted denial letter. Denial letters, after all, routinely list (as an aid to the patient) services which the insurance company judges to be reasonable alternatives to the denied care. While in this case the denied service offered some reasonable hope for prolonged survival, and the service being offered as an alternative (to say the least) did not, that’s really not so much different from the content of more “routine” denial letters. The difference is one of degree, and not of substance. So, Oregon Plan executives might be thinking, “What’s the big deal?”
One must try to be understanding of such insensitivity. It is a fundamental task of health plans to deliver unpleasant news to people whose lives are at stake, and it is normal – even necessary – for those who are charged with this task to grow thick skin. It is perfectly predictable that such thick skin might dull one’s ability to discern subtle differences in degree between various denials of services, subtle differences that might call for more artful phraseologies than those employed in this instance by the Oregon Plan. The failure to recognize the need for a more artful denial letter, Mr. Sellers appears to say, is the problem in the case of Ms. Wagner. The solution, consequently, is not a substantive change in any policy, but better public relations.
Those who run the Oregon Health Plan must be particularly disheartened to learn that even vocal proponents of physician-assisted suicide are criticizing their ill-considered denial letter. To so blatantly juxtapose healthcare rationing with the “option” of assisted suicide seriously undermines the chief argument advanced publicly by the end-of-life movement, namely, that assisted suicide is primarily an individual autonomy play*, and not primarily a cost-saving mechanism.
In other words, whether or not you embrace physician-assisted suicide, everyone seems to agree that offering it as a covered medical service immediately after denying potentially life-prolonging therapy is both insensitive and unseemly.
And so – as a public service to insurance executives in both the government and the private sector who are severely challenged by trying to understand simple human emotions, to patients like Ms. Wagner who may suffer true physical harm by exposure to such institutional callousness, and to the rest of us who simply would appreciate not being confronted so blatantly by the dark abyss that underlies our healthcare system – DrRich offers some friendly advice to health plans on the right way to sell physician-assisted suicide.
How Health Plans Should Sell Assisted Suicide
1) Don’t be so anxious.
Sure it’s easy to get excited about physician-assisted suicide. All you need to do is look at your own data. Whatever sort of health plan you are running, it’s likely that a huge proportion of your spending goes to patients who are in the last year of life. Enticing these end-of-lifers to choose assisted suicide (which you can accomplish in a sufficiently tasteful way for about $100) is such an attractive proposition that it’s indeed become very hard to make yourself appear reasonably circumspect about it. At the very least, it’s difficult not to push the idea out there to your subscribers. Otherwise how can you be sure they know all their options for end-of-life care?
But doing even that much is a mistake. If you don’t believe that, simply look at the small firestorm the Oregon Health Plan created with their simple and helpful “reminder” letter to Ms. Wagner. As a result, neighboring states that appeared ready to pass their own assisted-suicide laws are now having second thoughts about it. It is clear that for a health plan to seem overly interested in assisted suicide, or even to mention the option to their subscribers, is a very counterproductive idea.
A much more subtle approach is required.
2) Publicly disown assisted suicide.
Think about Tom Sawyer whitewashing the picket fence. Ole Tom didn’t get all his friends to paint that fence for him by asking for their help, or by overtly trying to sell or cajole them on the idea. Instead, he got them to do the job by pretending he wasn’t the least bit interested in having them do it, by ignoring them altogether, and making himself seem completely absorbed in the delightful task. By the time Tom was done, his friends were begging for a turn, and even giving him wondrous gifts (such as dead cats on a string) to bribe him for a chance to participate.
What you need to do is pretend that encouraging assisted suicide – even if it’s a covered service that patients ought to be made aware of – is the farthest thing from your mind. Instead, you are completely invested in and insistent upon providing full-service end-of-life care, with all the bells and whistles and no holds barred; and – while patients of course have the option to exercise their individual autonomy as they see fit – you take great pride in squeezing every last instant of life out of those elderly, used-up, chronically ill bodies that present themselves in your ICU, no matter what the cost to the patient and family in terms of pain, suffering, humiliation and anguish. It is your mission to stave off death to the bitter end, come what may, and you’re proud of it.
3) Have somebody else push it.
In the meantime, clear the path for agencies and interest groups which are dedicated to the end-of-life movement. There are plenty of them out there. Have them do the selling for you.
Make sure they have access to your patients and patients’ families, especially in the ICU setting. Allow them space for educational displays; provide them some private space where they can talk to interested patients and families; see that hospital social workers are aware of their presence. In the meantime, make it clear you do not endorse or encourage their efforts, and indeed wish they would go away, but are providing such groups with access in the interest of full transparency and your dedication to patient choice. If patients choose to avail themselves of such information, you will do nothing to stop them.
4) Make the advantages to assisted suicide seem real.
There’s no need for you to talk up the advantages of assisted suicide – let the end-of-life proselytizers do the talking for you. All you have to do is to make their arguments seem accurate. The great part is, that’s just a matter of maintaining business as usual.
The end-of-life zealots will tell patients that assisted suicide is a way of asserting some measure of control over the dying process, of holding on to some level of personal dignity at the very end. So simply make sure your end-of-life care continues robbing patients of any semblance of dignity and control.
They’ll tell patients that assisted suicide will end pain and discomfort and suffering when all hope of recovery is gone. So simply continue with inadequate pain control** and half-hearted comfort measures, and keep the ICU as hectic, loud, scary and impersonal as possible.
They’ll tell patients that assisted suicide will finally bring comfort to their long-suffering family and friends. So make sure family and friends suffer long, by keeping those ICU waiting rooms hot, cramped, noisy, uncomfortable and smelly.
You get the idea. Simply make sure the arguments of the end-of-lifers have teeth. You’re good at that.
5) Tell patients to consult with their doctors before making this choice.
That’s right. Refer patients to their doctors, their supposed personal advocates, the selfsame individuals you yourself have long since fatally compromised (by grabbing control of their individual professional viability). Assuming you have placed sufficient cost-cutting pressures on your doctors, then their willingness to encourage (or at least not discourage) assisted suicide will increase substantially. So when patients do consult with their doctors, the doctors will not undermine your subtle efforts, but will be your partners in convincing those approaching end-of-life to just be reasonable.
6) Make physician-assisted suicide legal, but not reimbursable.
You’re going for the Botox model here. You do not want physician-assisted suicide to be merely another hush-hush medical procedure, conducted quietly and almost secretly in a typical doctor’s office, so that people can pretend it doesn’t exist. Rather, you want to establish it as something that’s front and center, something people will want and ask for and go out of their way to seek. You want to encourage doctors to establish inventive business models for assisted suicide, just as dermatologists have done for Botox clinics.
Accomplishing this, of course, will require assisted suicide to be made legal everywhere (and not just in Oregon and a few other progressive states), but at the same time will require you to NOT make it a reimbursable medical service.*** For once it’s made reimbursable it will become subject to typical healthcare price controls, and you will severely limit the possibilities.
Think of those possibilities: One envisions physician-assisted suicide becoming established as a “life cycle event” like a wedding or Bar Mitzvah, where the right atmosphere, the right spirituality, and the right tone come together to create an unforgettable, uplifting experience for everyone. Some assisted suicides will take place in a doctor’s office, of course, but why not in a place of worship, a favorite city, a resort, a mountain top, a rocky coast, a casino? Why not allow the prospective decedent to actually hear the eulogies and experience the tearful tributes before actually engaging (ritually) in the Act? Why not partner with the deathcare industry to wrap the final healthcare service into a comprehensive package with funeral services? Why not engage American media to celebrate the event with a new mode of reality programming (one that is sure to garner a massive share of viewers)? Why not convert what is today an antiseptic, impersonal and frightening process into one that makes everybody present say, “Yes! That’s the way to go!”
The beauty is that this sort of model will convert what is today, at best, merely the option for assisted suicide into something that’s expected – a true destination event, a natural part of life. Indeed, not opting for assisted suicide, at a certain point in one’s life, will come to be seen as being unreasonable, greedy and selfish. And when granny begins to spend more time in a doctor’s office or (worse) in a hospital where frequent visitation is expected (and other family inconveniences are generated), some loving grandchild will pat her precious wrinkled hand, and say, “Granny, you know, it’s getting to be about that time. Wouldn’t a last weekend in Vegas be just the thing?”
So, if you play your cards right - passively encouraging the end-of-life movement in its effort to spread the word, while making the alternative (i.e., not committing suicide) as nasty and foul an option as possible, and also while coercing doctors and encouraging families to view assisted suicide as the most advantageous modus exodus one could ever imagine – well, the “right” to assisted suicide will shortly become the expectation and even the duty for assisted suicide.
And if those who run health plans will just follow DrRich’s program, you will have accomplished all this without seeming crass and self-serving as you most certainly do each time you send somebody a letter like the one you sent the unfortunate Ms. Wagner.
*Preserving the ethical precept of individual autonomy is the basis upon which modern utilitarian ethicists build their defense of physician-assisted suicide, passive euthanasia, active euthanasia, and even involuntary, secret euthanasia. DrRich will elaborate on the ethicists’ defense of doctors killing people in a future posting.
**This will simply require the government to continue severely and very publicly prosecuting the occasional pain-management doctor. Whether the target physician is actually engaging in analgesic excesses is unimportant to the goal of making any American doctor afraid of aggressively controlling their patients’ pain, for fear of becoming a target themselves.
***You may need to fashion the payment model so that assisted suicide is paid for in the case of hospitalized patients, and for patients in Medicaid programs. The point is to make assisted suicide a highly-desired self-pay service for anybody with enough money for a decent car or central air conditioning.
More Guidelines - Fighting For the Children
August 4th, 2008 by DrRich
A few months ago, DrRich addressed certain disadvantages that will arise from a policy of forcing physicians to practice medicine by guidelines. Essentially, once we decide to measure physician quality and determine physician pay according to how well they “perform” in following handed-down clinical guidelines, we will open a Pandora’s Box of dysfunctional and contradictory guidelines that will make the IRS code - or even the Medicare policy manual - seem straightforward and logical.
Payers are placing much hope in guidelines. They envision great cost savings through the simple expediency of adopting guidelines that leave out certain medical services they would like to avoid paying for.
But the payers have made the grave strategic error of fully embracing the “guideline movement” before securing for themselves control of the guideline development process. Apparently they missed the obvious fact that, if the practice of medicine is is reduced to following sets of guidelines, then any healthcare group and any medical organization with any stature whatsoever will begin manufacturing guidelines that direct doctors to do whatever it is that advances that organization’s agenda. That is, if guidelines determine who gets paid for what, then guideline development will become the chief byproduct of the healthcare system. We are beginning to see this chaotic process in action now.
DrRich, who delights in attempting to tease order from chaos, has suggested several specific categories of the dysfunctional guidelines that will inevitably flow from such a process. One of these categories he labeled “predatory guidelines.”
As an example of predatory guidelines, DrRich pointed to the recent recommendations advanced by the American Heart Association (AHA) urging that children with ADHD be screened with ECGs before they are placed on stimulant medication. Those ECGs, the AHA went on to explain, should be interpreted not by the pediatrician, but instead by “a pediatric cardiologist or a cardiologist or a physician with expertise in reading pediatric electrocardiograms.”
In making this recommendation the cardiologists of the AHA have attempted to encroach upon the turf of the pediatricians, ostensibly to save the lives of innocent children, but in a manner that will inevitably increase business for cardiologists by a) generating hundreds of thousands of ECGs for them to interpret at $25 - $50 a pop, and b) generating tens of thousands of echocardiograms and other cardiac tests that will be necessary to evaluate all the equivocal (and to a very large extent false positive) ECGs that will result from this routine screening, while c) explicitly leaving the pediatricians themselves out of the process.
DrRich predicted at the time that the pediatricians would not allow this invasion of their turf to stand, and that they would find it necessary to counter with their own set of guidelines. And so, what began as “predatory guidelines” from cardiologists would likely degenerate into “dueling guidelines” between cardiologists and pediatricians.
DrRich is delighted to report that his prediction has now come to pass.
The American Academy of Pediatrics (AAP) has just released a policy statement suggesting that the AHA is guilty of promulgating bad advice. Indeed, the AAP finds, it is not necessary to perform routine ECGs on children with ADHD prior to giving them stimulant medication. Further, the AAP pointedly demonstrates that the AHA’s recommendations were based on faulty science (that is, the AHA failed to follow the principles of evidence-based medicine), and that those recommendations give at least the appearance of being self-serving. Finally, the AAP notes that since routine ECG screening produces many false positive results, which themselves require further cardiac testing, this screening actually produces more harm than good. So, the AAP concludes, not only is there no need to do routine ECG screening, but also doing the screening would produce net harm. The AAP statement stops just short of accusing the AHA of malfeasance.
And so, DrRich would like to thank the AAP for so clearly bearing out his prediction that “predatory guidelines” will always tend to yield “dueling guidelines.”
Needless to say, the cardiologists are not happy about this new development. Dr. Steven Nissen (famous of the Cleveland Clinic, and also famous for producing inflammatory statements pretty much on cue) tells TheHeart.org (professional registration required) that “the AAP statement is misguided.” Nissen also suggests, perhaps a bit gratuitously, that the pediatricians (and their friends, the detestable shrinks) are tossing amphetamines around like candy. He says, “This is the second time in a few weeks where the AAP has issued poorly thought out guidelines that promote inappropriate drug use in children. The previous statement promoted statin use in children as young as 8 years of age.”
(DrRich is sympathetic to the notion that the diagnosis of ADHD might be a tad overdone these days, to the point where being a boy is all but an official disease, for which drug therapy is frequently urged and often prescribed. But still, in the debate over whether children diagnosed with ADHD should have ECG screening before being drugged, the assertion that they are being overtreated in the first place is actually beside the point.)
Both sides in this now-very-public debate seem to have some valid points, and to DrRich’s estimation neither side is obviously completely right or completely wrong. Cardiologists are correct in pointing out that stimulant drugs do have cardiovascular effects, and it is logical to think that kids who are susceptible to cardiac arrhythmias might be at higher risk on these drugs, and that screening these kids might save some lives. But the pediatricians are correct in pointing out that the data that has been collected so far does not show any increase in sudden death in kids on drug therapy for ADHD when compared to the general population, that the same cardiovascular effects caused by these drugs are also caused by everyday activities such as running, jumping, and the sort of emotional outbursts that children with untreated ADHD may have from time to time, and that, besides, doing ECGs on all these kids has a known downside in terms of unnecessary procedures and increased cost.
So, in addition to being unseemly, these dueling guidelines create a dilemma (instead of guidance) for doctors who are actually attempting to care for children with ADHD. One set of guidelines says that screening is necessary to save lives; the other (from an equally regarded professional organization) says that not only is screening unnecessary, but also harmful. Whatever the doctor does, if there is a bad outcome the plaintiff’s attorney will come pre-armed with one set of guidelines or the other which will prove that, no matter what the doctor did, it was the wrong thing.
These dueling guidelines also demonstrate that many important medical questions are simply not suitable subjects for guidelines. Guidelines are fine when a medical issue is resolved, that is, when there is substantial agreement among experts (of all relevant factions) as to how patients with a certain medical condition ought to be managed. But guidelines are helpful only when the clinical question is sufficiently ripe. Premature guidelines - the ones promulgated for some other reason than that the optimal clinical pathway has been resolved - will cause harm (and often, ironically, will increase cost).
Nonetheless, the notion that the practice of medicine can be completely reduced to sets of guidelines (a notion vitally attractive to insurance companies and government bureaucrats), now has been broadcast with great fanfare across the land. It is through guidelines that we will finally homogenize healthcare, and establish the tools by which clinical excellence can be tabulated and costs can be controlled. So, as a consequence of this generally agreed-upon fiction, swarms of guidelines are now flying out of the medical establishment like bats out of a cave. We can expect many of these guidelines to be created not because clinical science warrants them, but instead to covertly ration care, to protect professional turf, or to aggressively extend one’s interests onto entirely new turf.
And so, spectacles like this one, where cardiologists and pediatricians have become engaged in a rather nasty turf battle (fighting for the children, as it were), will be repeated countless times across the medical landscape.
Cry havoc, and let loose the dogs of guidelines!
Skin in the Game
July 30th, 2008 by DrRich
The New York Times recently took dermatologists to task for creating a two-tiered system of dermatology - one for patients with skin disorders, and one for “cosmetic dermatology.”
As the Times describes it, patients who wish to see a dermatologist for, say, possible skin cancer are put on a waiting list, and when their appointed time finally arrives (generally months later) they are subjected to modern medical hell. To wit: Upon arriving in a lackluster office, the patient is shelved for a while in an unattractive, poorly lit waiting room equipped with a broken TV, old magazines, unruly children of other patients, and surly office personnel. Eventually her name is called by a not-necessarily-pleasant nurse practitioner who will “triage” her to the appropriate category (e.g., acne, fungus, cancer, warts- you know, dermatology stuff), have her strip in order to fully expose the large surface-area organ (the skin) for which she has sought assistance, give her a scratchy yellow paper gown to cover her nakedness, and have her wait for some time in a chilly exam room to see the actual doctor. At last the dermatologist arrives, mutters a greeting (or some other ritual uttering), glances at a clipboard, and announces, “Show me your [acne, fungus, cancer, warts];” whereupon, having regarded the cause of cutaneous concern and having made a professional determination, he either signs the prescription that has been pre-written for him by the nurse practitioner, or schedules a procedure. Then, shoving into the patient’s arms her bra and other structural and non-structural equipage, the doctor pushes her out into the hall, as the formal interview is over.
Presumably, one hopes, some dermatology practices not visited by the New York Times might not be quite so bad. Still, anyone who’s been seen by an American PCP lately will nod sympathetically at the dermatology patient’s ordeal.
Now observe what the Times observes when the patient, instead of having an actual skin problem, merely is sagging here and there and wishes to be shorn up. That is, the patient has a cosmetic issue. That is, the patient wants Botox.
The same dermatologist will often have an entirely different setup for these patients. This time the patient is seen immediately, possibly the same day, as dermatologists are sensitive to the needs of those who are about to appear in public, say, at an impending dinner party. If this patient is to wait at all, she will wait in a modern, tastefully decorated private room. She will then be seen not by a mere nurse practitioner but by an aesthetician, who will do a formal assessment of the sagging parts, and, aside from suggesting more injection sites than the patient might originally have had in mind, will offer a complete program for long-term cosmetic maintenance, which naturally will include quarterly Botoxification. At just the proper moment the dermatologist comes in, greets the patient warmly and reassuringly; then reviews the recommendations of the aesthetician and discusses those recommendations at length with both the aesthetician and the patient, studying the patient’s face in depth as he does so, pointing, nodding, agreeing, adjusting, all the while smiling confidently. Yes, he indicates, we will all be very happy indeed with the results. Finally the doctor begins to make the now-thoroughly-discussed-and-agreed-upon injections, doing so with the greatest solicitation and sensitivity. The patient is then given as much time as she needs to collect herself, and is invited to “recover” in a room set aside for this purpose with flattering lighting, soft music, a cappuccino machine, and perhaps a glass of wine. She leaves the office a new person. And, just as the dermatologist has promised, all are indeed very happy with the results.
Naturally, the New York Times is scandalized by the dichotomy which its discerning readers will note here. Why should a patient with a mere cosmetic issue be treated so well, when a patient with an actual medical problem, possibly even skin cancer, is treated so shabbily? How can dermatologists openly encourage such a two-tiered system?
DrRich has a word of advice for the commentators and reporters of the New York Times and any other concerned Americans worried that dermatologists, by setting up separate-but-not-equal practices for their two kinds of patients, are moving us one step closer to the dreaded two-tiered healthcare system we all abhor. That word is: Chill.
Allow DrRich to support this friendly recommendation with two observations.
1) We already have a multi-tiered healthcare system, and little or none of it is the fault of dermatologists. It is the fault of human nature. All countries have at least a two-tiered healthcare system, including countries (like Cuba and China) that have specifically embraced egalitarianism (rather than individual autonomy) as the fundamental operating principle. The second tier, like the poor, will always be with us.
2) When a dermatologist spends Tuesday afternoon in her run-down office, treating people who come to her for bona fide skin disorders like they’re widgets on an assembly line, then goes to her other, better office on Wednesday, treating the merely cosmetically-challenged like minor nobility, she is not really engaging in two-tiered healthcare. Not at all. Instead, she is practicing real, true, prescribed-by-society, by-the-book American healthcare on Tuesday, and doing Something Altogether Different on Wednesday.
Injecting Botox is officially and formally not part of American healthcare. How do we know this? Because it is not covered by Medicare or health insurance. If you want Botox you’ve got to pay for it your own self, just as you do if you want a TV or a car. So by all that is sacred, injecting Botox is NOT American healthcare.
Furthermore, when one looks objectively, injecting Botox is not even really practicing medicine, at least not in any true sense. In actual truth, it takes very little training or expertise to inject Botox. There’s no reason one must go to college, graduate from medical school, or do several additional years of training in dermatology (or any other specialty) to do this. Anyone with a needle and syringe, an alcohol wipe, and access to Botox could do as well. Just find the wrinkle and stick it. If they made the materials available over-the-counter, folks would do just fine with it.
Of course, doctors in general (and dermatologists in particular) have legally cornered the market on Botox injections. So it’s not like you could just set up a booth at the Mall and hire high school students to do this (as you can for, say, ear-piercing - which, in contrast to Botox injections, is an actual surgical procedure which results in a permanent structural change in a body part). If you set up a chain of Botox Booths, you would be practicing medicine without a license, which is a serious offense.
And consider this. Dermatologists could just as easily have taken up a somewhat different well-known cosmetic procedure, one that also involves injecting substances through the skin via needles, and that has much more to do with the skin itself than Botox injections (which actually do not affect the skin itself at all, only the muscles under the skin), but they chose not to. DrRich speaks, of course, of the tattoo. But unlike making Botox injections, tattooing requires real skill, knowledge, training, expertise and artistic talent. Most dermatologists simply could not manage a highly-technical skill like that.
The point, of course, is that injecting Botox does not involve intrinsic skill, knowledge, difficulty, risk, or any other objective characteristic that necessarily renders this a medical procedure while ear-piercing and tattooing are not. Viewed from this perspective, one must conclude that declaring the injection of Botox to be a medical procedure, which cannot be performed by anyone not having a medical license and years of specialty training, is an entirely arbitrary determination.
Fundamentally, then, while performing Botox injections may have a certain legal status, in any true sense it is not really practicing medicine. Rather, it is simply an activity some dermatologists may choose to do when they’re not doing real dermatology.
Doctors engage in this sort of thing all the time. That is, they partake in activities other than practicing medicine when they could, in fact, be seeing more patients. Some have taken up golf. Others have started side businesses such as restaurants or software companies. Some go to graduate school (usually for MBAs). Still others have opted to work part time in order to raise their families.
Society generally finds such activities acceptable, and - to this point - does not insist that all doctors forego all other human endeavors in order to see as many patients as humanly possible, during all their waking hours. While society seems to be moving closer to declaring