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.

Posted in General Rationing Issues, Cardiology Topics, Evil Drug Companies | 8 Comments »

Crestor, Guidelines, Rationing and Other CRP

November 13th, 2008 by DrRich

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

On its surface the study and its results are pretty straightforward. Nearly 18,000 men and women from 26 countries who had “normal” cholesterol levels but elevated C-reactive protein (CRP) levels were randomized to receive either the statin drug Crestor, or a placebo. CRP is a non-specific marker of inflammation, and an increased CRP blood level is thought to represent inflammation within the blood vessels, and is a known risk factor for heart attack and stroke. Patients randomized to Crestor, after an average treatment period of 1.9 years, had a highly significant 44% reduction in a composite endpoint that included heart attack, stroke, the need for stenting or bypass surgery, and cardiovascular death. Both CRP and cholesterol levels were also significantly reduced in patients taking Crestor.

This study is noteworthy because it is the first large randomized trial to show that Crestor (or any statin) can markedly reduce the incidence of some very nasty cardiovascular outcomes in people who are considered to have “normal” cholesterol levels.  (Notably, typical LDL cholesterol levels among primitive hunting/gathering cultures is around 50 mg/dL, instead of the 100 - 120 mg/dL we consider to be normal. These people have an extremely low incidence of cardiovascular disease, so maybe humans’ optimal cholesterol level is much lower than we now think. On the other hand, the low risk of cardiovascular disease among hunters/gatherers may instead be related to the fact that many of them are consumed by bears before they’re 30.)

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

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

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

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

But still, there should be no controversy here. If medicine were practiced the way it ought to be - where the doctor takes the available evidence, as imperfect as it always is, and applies it to each of her individual patients - then the JUPITER trial would present no special problems. After all, doctors never have all the answers when they help patients make decisions. So, in this case the doctor would discuss the pros and cons of statin therapy - the risks, the potential benefits, and all the quite important unknowns - and place the decision in the perspective of what might be gained if the patient instead took pains to control their weight, exercise, diet, smoking, etc. At the end of the day, some patients would insist on avoiding drug therapy at all costs; others would insist on Crestor and nothing else; yet others would choose to try a much cheaper generic statin; and some would even opt for a trial of lifestyle changes before deciding on statin therapy. In other words, there is a range of reasonable options given the limitations of our knowledge, as there often is in clinical medicine.  As time goes by, more scientific evidence is often brought to bear and clinical decisions (hopefully) become more and more effective. But whatever the state of the evidence, doctors and patients can generally get by without violating too severely any ethical or medical precepts that would cause objective and neutral observers to complain very much.

But we don’t practice medicine the way it ought to be. We practice it according to guidelines.

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

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

On one hand, many point out that JUPITER is an important clinical trial which has demonstrated a vital clinical benefit (prevention of heart attack, stroke and death) with a high degree of statistical significance, which meets the high standards demanded by evidence-based medicine, and which therefore obviously demands a change in the clinical guidelines. But on the other hand, many others insist that the JUPITER trial simply does not demonstrate enough of a benefit with Crestor to justify changing the guidelines.

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

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

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

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

These people fall into two general camps. First, and easier to dismiss, are those who believe that drug companies are the embodiment of evil, and that any clinical trial sponsored by a drug company must be dismissed out of hand. There is furthermore a subset of this group who believe that statins, in particular, are the devil’s work, and represent some sort of effort on the part of the pharmaceutical companies (all of which seem to market a statin of one variety or another) to enslave every American. These people, one can only surmise, would object to statins even if they were proven to cure heart disease, cancer, baldness, obesity AND to produce fine and durable erections upon demand.

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

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

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

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

In short, they find themselves forced to engage in statistical legerdemain in order to diminish the significance of the JUPITER trial. From what DrRich has seen, most of the statistics that have been ginned up to this end have not come directly from the JUPITER trial itself, but instead from an editorial accompanying this study, written by Dr. Mark A. Hlatky.

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

This statement, at least taken at its face value as a stand-alone analysis, is statistically naive and wrong. DrRich will not make anyone wade through the reasons why, because he realizes that one or two of his readers might not enjoy statistical arguments. (Instead he will provide those reasons in this footnote.*) Suffice to say here that Hlatky’s summary statement apparently ignores the appropriately analyzed data which is clearly presented in the JUPITER paper itself, and which documents that the clinical benefit of Crestor was substantially more impressive than this widely-quoted summary statement by Hlatky suggests.

As illegitimate as this summary statement may be, let us accept it for a moment just for the sake of discussion, since that’s the data the antialterguidelinetarians have latched on to. Taking these numbers, the “antis” make the following argument: While the relative reduction in “hard cardiac events” is 50% (1.8 to 0.9), the absolute reduction is only 0.9%, which, anyone would agree, is a pretty small number. So, they conclude, the actual benefit imparted by Crestor is actually quite small.

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

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

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

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

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

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

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

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

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

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

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

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

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

Primary Care: Time to Reboot

April 8th, 2008 by DrRich

American primary care medicine has entered into a period of change. “Change” is perhaps too mild a term; many - especially the primary care practitioners (PCPs) themselves - might call it a period of crisis. In any case it is change so profound that one might be forgiven for thinking Senator Obama is already president.

Consider. PCPs have been hogtied to a dysfunctional reimbursement system that (thanks to the government, the insurers, the AMA, and their own specialist colleagues) has drastically and systematically devalued their training, expertise, and time. The very concept of what a PCP is and does (and indeed, what they should be called - whether PCP, family doctor, general practitioner, gatekeeper, or medical homemaker) seems in constant flux.

Whatever it is PCPs do, the government, the insurance industry, and experts on medical policy have spent years making the primary care job seem, well, easy. Their practices have been reduced to a series of discrete, easily cookbookified tasks. Each of these tasks can be directed by “guidelines” (devised, of course, by non-PCP “experts”), compliance to which can be easily tabulated and monitored, thereby to determine the adequacy of the individual PCP’s performance. And, because their job is now so codified, they are expected to perform it accurately and reproducibly in a matter of minutes (some say 7.5 minutes per patient encounter, though others will allow up to 12.5), just like any other rote industrial process.

To make matters worse, PCPs are slowly awakening to the realization that they are being squeezed out from the bottom. Some of what they do (the really easy stuff) is being corporatized into mini-clinics by the large drug store chains, and the rest is being threatened by newly assertive nurse practitioners and doctor-nurses, who are at least tacitly supported by the insurance industry. (Thanks to Dr. Poses for pointing out the relationship between doctor-nurses and big insurance.)

No wonder PCPs have become so terminally frustrated.

It is natural for PCPs to want to fight the changes that are destroying their profession, and causing their numbers to dwindle. Many have offered ideas. Gain the public’s support by alerting them to the impending and dangerous shortage of PCPs. Improve PCP payment schedules. Forgive the student loans of young doctors who choose primary care. Lobby congress for pro-PCP legislation. Offer novenas.

Some of this (DrRich is thinking the novenas) might hold off the inevitable for a time. But PCPs are fighting more here than just the government, the insurers, their specialist colleagues, and nurses filled with thoughts of vengeance (for 150 years of having to give unquestioning obedience to arrogant, clueless and unfeeling doctors, if you care to ask them). The PCPs are fighting history.

What is happening to PCPs is what happens to many experts whose jobs are fundamentally based on knowledge and/or technology. That is, as knowledge and technology advance, some (and perhaps a lot) of what the experts do can be sufficiently simplified and “democratized” that less well-trained individuals become enabled (or believe they are enabled, which amounts to the same thing) to do it themselves.

This is what the market is telling PCPs has happened to them. A substantial part of what they do indeed has been reduced to guidelines and cookbooks (thanks to remarkable advances in clinical studies and medical technology). The typical patient (note: DrRich said “typical”) with hypertension, diabetes, cholesterol abnormalities, and common infections can be relied upon to respond reasonably well to reasonably standardized therapy. And the market is saying to the PCP: “We can find ways of doing this without you.”

The same thing has happened countless times in history. The 1500-year monopoly enjoyed by the clergy in interpreting the Word of God was completely disrupted by the printing press and by the upstarts who translated scripture into the vernacular. The music industry has been fundamentally disrupted by digital recording software, which enables anyone with a PC to do things that had always required multi-million dollar studios. Ditto for book publishing. Ditto for real estate agents, accountants, car dealers, teachers, newspapers. All are wrestling to one degree or another with the “creative destruction” that is produced by advancing knowledge and/or technology.

For the most part, of course, nobody (except, perhaps, the doctor-nurses) will come right out and tell the PCPs to go away altogether. Instead, they’re telling them to dumb down, to just follow the rules, to stick to the guidelines and be paid to perform (one thinks of trained seals), to become like the lesser-trained practitioners who inevitably will be replacing them over the next decade or so. That’s where the profession is going, they’re being told. Get with the program, adapt to reality - or don’t let the door hit you where you keep your wallet.

Looking at the situation from this more historical perspective, one can see why it seems futile for PCPs to respond by railing and complaining, by lobbying for the public and the legislatures to understand that they’re actually quite important, by appealing to their specialist colleagues for more than lip-service support, or by trying to convince more medical students to choose a disintegrating profession such as this.

PCPs are in the path of a tidal wave of disruption, triggered by economic realities and enabled by technology. They are unlikely to prevail by a’wishing, and a’hoping, and a’singing, and a’praying.

From the perspective of history, it becomes apparent that what PCPs need to do is reboot. They need to reinvent themselves in a way that is compatible with the new reality. So far, they seem to be seeing only the disruption part of the creative disruption now tearing their profession apart. They need to find the creative part.

From a simple examination of history, two possibilities will immediately come to mind.

1) Just as advancing medical knowledge and technology has made it possible for lesser-trained individuals to encroach on their turf, so have the same advances made it feasible for PCPs to encroach on the turf of their snugger (and smugger) colleagues - the specialists. Observing how some of the bread-and-butter skills of the PCP have been sufficiently reduced to the point that nurses can do it, one finds it inconceivable that similar basic skills now monopolized by specialists haven’t been similarly reduced. It is undeniably true that for a lot of what specialists do, one doesn’t actually need a specialist anymore to do it. (As a cardiologist, DrRich knows for a fact that this is the case, but unfortunately he is bound by blood-oaths extracted by the high priests of his guild - oaths which mortgaged the immortal souls of his progeny down through 10 generations - not to mention the specifics. Sorry.) But look around. You’ll find examples easily enough.

Fundamentally, advancing technology allows individuals to migrate upwards into areas formerly occupied only by more specialized individuals. This is a law of technologically progressive societies. That nurses are aggressively migrating upwards onto the turf of PCPs is merely a case in point. So, rather than fighting a doomed-by-history rear guard action against the advancing army of nurses, why should PCPs not instead launch a blessed-by-history invasion of their own, against the smugocracy (the people whose jobs end in -ologist)? Heck, they’ll even have the insurers and the feds on their side for once (for the same reason the doctor-nurses now do). Wouldn’t that be novel?

2)Another law of technologically progressive societies is that, whenever specialists are displaced by upwardly mobile, technology-enabled non-specialists, there will always be a portion of the customer base that is likewise displaced. That is, the new, less-sophisticated service providers will be able to provide useful services to a majority of customers - but not to all customers. The customers with high-end needs, who are left out under the new regime, present a new business opportunity.

PCPs operate in a world where the majority of their patients probably have relatively common, relatively easily cookbooked medical problems, and most of these patients will do just fine with their new doctor-nurses. But a substantial minority will have high-end needs, either in terms of complex medical problems that cannot be reduced to simple treatment pathways, or in terms of atypical medical problems that are not easily diagnosed.

DB has discussed at some length this “long tail” in the patient population, as defined by some aspect of material complexity in their medical conditions. The long tail simply cannot be served by guideline-directed care, whether administered by doctor-nurses, or by those more malleable (or complexity-averse) PCPs who will simply allow themselves to be absorbed by the new, dumbed-down primary care regime. Long-tail patients, the outliers, will not be small in number. They will comprise an important new business opportunity, “new” because it is a niche that is not recognized today, as it will be when these patients are being systematically (instead of randomly) culled out.

That business opportunity can be filled by many of today’s PCPs. These will be doctors who enjoy puzzling through complex diagnostic problems, and dealing with complex management issues, and have been trained to do so. To DrRich, this spells “internist.” Doctor-nurses can’t do this job. Specialists can’t do it either. This will be a specific niche for internists.

The best part is that the feds and the insurers, in selling us on the dumbed-down PCP model, are busily assuring us that there is no substantial need for sophisticated PCPs (hence, the appropriateness of doctor-nurses). And in proving the point they’ll be able to rely on carefully constructed, population-based outcome measures (which, since they speak to the average patient, will look very favorable) to marginalize the complaints of the outlying patients. Having refused to acknowledge the existence of complex patients, they’ll hardly be able to make special provisions for their care.

This leaves the door wide open for internists to establish practices to provide healthcare services to patients with difficult diagnostic or management problems, who are being neglected and mishandled by the “official” healthcare system. (These patients know who they are, and are desperately looking even today for somebody to help them.) And since to insurance companies and the feds these patients don’t exist, these practices will have the opportunity to operate outside the system, as private-pay practices, which will eliminate the demeaning checklists, the one-size-fits all guidelines, and the stifling time limits under which PCPs now must operate. And, like plumbers and electricians, they can get paid for what their time and expertise is worth.

(To those of you who immediately object to such a thing because asking patients to pay themselves for medical care is unethical, DrRich asserts it is indeed possible to do this entirely fairly and ethically, while allowing almost anyone who wants this kind of service to have it, and some day he will describe how. But for now, just celebrate the right of people to spend their own money on their own healthcare even when it’s provided by actual physicians, just as [DrRich suspects] you celebrate their right to spend money on chelationists, homeopaths, or reiki practitioners.)

The bottom line, as DrRich sees it, is that the identity crisis now being experienced by American PCPs, while certainly catalyzed by healthcare economics and politics, is a manifestation of the natural and inevitable disruption produced by advancing knowledge and technology. PCPs may be the first, but all physicians will soon face similar challenges as long as medicine continues to advance.

If the PCPs respond logically to this crisis - that is, instead of fighting it, recognizing the opportunities it presents - their specialist colleagues will soon experience their own “encroachment from below,” which is the hallmark of a mobile, technologically progressive society.

Posted in New business models for healthcare, Primary Care in America | 20 Comments »

How Important Is Cholesterol, Really?

January 24th, 2008 by DrRich

In addition to being the Rabble-Rouser-In-Chief for this fine blog and its groundbreaking parent website, DrRich for several years has also been the cardiology expert at About.com. (About.com is a New York Times company, but since his association with About.com predates that of the NYT, DrRich sincerely hopes that his more conservative readers will not hold this against him.) In this capacity, DrRich routinely tries to clarify for his readers (who are mainly patients with heart disease and their loved ones), controversial topics in heart disease. Because cardiologists (like all theologians) never tire of arguing over how many angels can dance on the distal pole of a defibrillation lead, and because the popular media delights in reducing these arcane arguments to breathless (and commonly misleading) headlines, there is a never-ending cascade of material upon which DrRich can draw.

Most recently, the results of a clinical study called ENHANCE has had many in the popular media (in response to new concerns voiced by medical experts), questioning the deeply-entrenched cholesterol paradigm - that is, the idea that LDL cholesterol (the bad kind of cholesterol) is indeed bad, and that anything we can do to lower it is good. Questioning the cholesterol paradigm - a belief system we’ve all been taught since we were babes in arms - is deeply disturbing, confusing and troublesome to many American patients (judging, at least, from the response DrRich has received from readers of his heart disease site).

These patients have been told for years to arrange their lives around the reduction of their cholesterol levels. And while the proportion of people who actually do so does not exceed the proportion who, in earlier times and under a different paradigm, actually arranged their lives so as to further their odds of spending eternity in paradise (modern sinners often preferring instead to rely on today’s equivalent of the deathbed conversion - the stent), the sudden notion that the cholesterol god is dead leaves these patients unbalanced, uncentered and oddly empty. They are also beginning to believe that their doctors, who (some appear to be saying) have been preaching a false doctrine at them for many decades, are even more full of cr*p than previously thought.

In response to this existential crisis, and so as to fulfill his duties to About.com and its parent company, DrRich has posted an article that purports to place all this in perspective, and more importantly, to give patients some guidance as to how to proceed in regard to their cholesterol therapy NOW (i.e., during the next 10 years or so, while the experts debate the issue, and argue over whether the current guidelines - the following of which doctors will continue to be paid-to-perform - actually make sense.)

Normally, DrRich would not trouble readers of the Covert Rationing Blog with topics pertaining to his other duties. But this recent cholesterol controversy has already attracted the attention of other medical bloggers he admires, some of whom have offered (for instance, here and here) very level-headed opinions on the matter. Frankly, while DrRich is clearly very comfortable pontificating on matters related to healthcare reform (and most other topics), he gets nervous touching on theology or its close relative, cholesterology. So DrRich will be very interested to know from readers of this blog if his advice - which, again, is aimed at American patients - seems sufficiently clear, and most of all, reasonable. The posting can be found here.

Thank you for your indulgence.

Posted in Cardiology Topics | 3 Comments »

Pay for Performance and Covert Rationing (2)

September 14th, 2007 by DrRich

In a previous post, DrRich described the most obvious problems with Pay for Performance (P4P) when applied under a system of covert rationing. In the present post he addresses some of the more subtle and insidious aspects of P4P.

Consider, firstly, that the large insurers - and to some extent Medicare - have by now successfully dictated to primary care physicians that they can spend only 7.5 minutes (or perhaps 10 minutes if they’re lucky) per patient visit. This mandated brevity, indeed, is one of the chief complaints voiced today by both primary care doctors and their patients.

On the heels of this considerable success these same third-party payers now have launched P4P, which gives them the ability to dictate exactly how those doctors must spend their 7.5 minutes. If the doctors hope to avoid (at best) missing out on their 5% bonus or (more ominously) getting blackballed for delivering poor quality care, they’ll spend that allotted time doing whatever their P4P checklist says they must do.

Doctors can’t possibly do everything; P4P relieves them of the burden of having to decide which of the important patient care tasks they’ll do, and which will have to wait for a more propitious time, such as when the cows come home.

Now, DrRich will be the first to admit that most of the things on the P4P checklist seem potentially useful or at least benign. You can look at common P4P-approved tasks in a report from PriceWaterhouseCoopers, and see for yourself. How can anyone argue with cancer screening, cholesterol management, diabetes management, or the appropriate use of asthma drugs? These things are all good for patient care, aren’t they?

Sure they are. In fact, the designers of P4P programs have taken pains to make sure that the items they have put on on their checklists to date will not only reduce costs, but, whenever possible, will also be reasonably likely to improve patients’ health (or at least will be perceived that way). It’s one of the things that makes criticizing P4P so unrewarding.

But one would have to be very credulous indeed to believe, despite vociferous protestations declaring it to be so, that insurance companies and the feds are making a Manhattan Project out of P4P purely out of their passion for good outcomes. It is clear that reducing the cost of care is the chief driver of the P4P movement, and if it isn’t likely to reduce the cost of care, it isn’t going to make the P4P checklists.

Unfortunately, many patients need medical care that isn’t going to reduce the overall cost of care. Quite the contrary.

Take, for example, the 20% of Medicare patients who have at least 5 chronic medical conditions, and take at least 5 prescription drugs. Tending maximally to each of those medical conditions will likely cost a lot of money. Holding the office visit to 7.5 minutes, of course, goes a long way toward limiting the care that can be provided. But it still leaves the doctor with a disturbing degree of latitude. When deciding which of these problems to address during the brief office visit, the unfettered doctor might well choose a problem whose optimal management will greatly increase the cost of care. But happily, under P4P the decision of which problem to address is already made. The checklist reveals the appropriate choice.

For another example of optimal medical care greatly increasing the cost of care, consider the hundreds of thousands of heart attack survivors each year who are at increased risk for subsequent sudden death. Good clinical studies, supported by formal guidelines, recommend implantable defibrillators for many of these individuals. But implantable defibrillators, being extremely expensive, are mysteriously absent from anyone’s list of P4P clinical practice guidelines. (The sad fact is that preventing sudden death by any method, no matter how cheap - since it would prolong the life of patients who would otherwise continue consuming lots of healthcare due to their underlying heart disease - is diametrically opposed to the real purpose of P4P. Under a system of covert rationing, preventing sudden death is simply bad public policy.)

But P4P not only limits the options of the doctor. It also limits the options of the patient. While patients have the right to turn down therapy that is recommended by P4P guidelines (and that is duly parroted to them by their higher-quality physicians), they are unlikely to be offered alternative choices not sanctioned by the guidelines, unless that alternative therapy is cheaper, or their doctors are willing to defy the insurance companies or (even less likely) the heavy hand of the feds.

Finally, since succeeding with many of the P4P measures requires not only that the doctor treat the patient appropriately, but also that the patient become fully compliant with the treatment recommendations (carefully following, for instance, their diabetic regimens), P4P may cause doctors to avoid accepting into their practices patients who seem unlikely to follow their instructions. Such patients will tend to include the poor, the disadvantaged, and the undereducated. But then, in all fairness to P4P there’s really nothing new here; these individuals are already the most likely victims of covert healthcare rationing.

So P4P offers many advantages to a healthcare system predicated on covert rationing.

  • It pushes doctors to do the things, useful or not, that reduce the cost of healthcare.
  • It prevents doctors from doing the things, even if useful, that increase the cost of healthcare.
  • It helps weed out or change the behavior of doctors who “think they know better” than the centralized agencies of medical excellence.
  • It limits the options presented to patients.
  • It induces doctors to “cherry-pick” compliant patients, leaving the less accommodating ones to go fend for themselves.

No wonder everyone is on the P4P bandwagon.

Posted in General Rationing Issues, Primary Care in America | 2 Comments »

Another Reason Patients Should Review Their Health Records

August 30th, 2007 by DrRich

In the Wall Street Journal today, Victoria E. Knight writes that smart patients will always review their medical records for accuracy.

“Not only can incorrect medical information lead to ineffective or harmful treatment — the Institute of Medicine estimates that as many as 98,000 patients die each year in hospitals from medical errors — it can also affect your insurability.”

Your health records, she points out, are analogous to your credit scores.

“Savvy consumers know to check their credit score before applying for a loan. What is less well known is that consumers can improve their chances of getting insured — and of paying lower premiums — by checking that medical information held by doctors, hospitals and pharmacies is accurate.”

There are a lot of reasons errors can appear in your file.

“Mistakes can arise from a mistyped diagnosis code or transcription error to an inaccurate diagnosis or a diagnosis that is out-of-date, say because a patient has gotten his or her cholesterol under control. And, if you have a common name, other peoples’ records can end up in your file. . .”

This is all very true, and these are very good reasons you should check your medical records. But in the spirit of this blog, DrRich would like to point out another reason.

You should check to see if your doctor is using your medical records for CYA purposes. This is especially true if you are a patient with a potentially expensive medical problem which, if your doctor followed all the guidelines to the letter, could result in substantial “medical loss” for the third-party payer (i.e., the doctor’s boss).

An example (which, in DrRich’s own clinical experience, is distressingly common): Say you’re a recent heart attack survivor. You’re pretty conscientious about taking all the medicines your doctor has prescribed to reduce your risk of another heart attack, and you’ve even changed your diet and started a walking program. Truth be told, you’re actually feeling better than you have in years. But then one day while putting the dishes away you have some kind of “spell.” One moment you’re opening a cabinet, feeling absolutely fine; the next, you find yourself laying on the floor with a bruised chin. Your wife, having heard a crash, is just now rushing in from the next room - so you know you were “out” only for a couple of seconds.

So, you go to see your doctor. You tell him what happened. He asks a few questions, nods, looks serious for a moment, then smiles and says, reassuringly, “Well, <Your Name>, I don’t think this is really anything to worry about. Sounds like you were just a little dehydrated. Happens all the time after a heart attack, what with all the pills and all. Really, nothing to worry about.”

Happy that the doctor thinks it’s nothing, you leave the office relieved. But might be surprised to read the note your doctor has put in your medical record:

“<Your Name> in for checkup. Doing well. Complained of an episode of significant lightheadedness two nights ago. Lost balance and fell, with minor trauma. Says thinks he was dehydrated from exercise program. Has felt well since. Nothing to suggest arrhythmia.”

This is a classic CYA note. Sudden, unexpected loss of consciousness after a heart attack is OFTEN due to potentially life threatening cardiac arrhythmias, and should ALWAYS be treated as a potential harbinger of impending sudden death. Unfortunately, treating it as a serious problem is usually expensive, requiring at least a hospitalization, and (if the evaluation is positive) the insertion of an implantable defibrillator. Such an outcome will not improve the doctor’s cost profile with his master, the third-party payer.

Your doctor should know that you are potentially at very high risk for sudden death. If he doesn’t know that, he’s stupid, and stupid is bad when it is seen in doctors. But stupid isn’t as bad as dissembling. And dissembling is what his note indicates.

Your doctor’s note does not accurately reflect what happened to you, or what you actually told him about the episode. Instead, it alters the facts just enough to make it seem reasonable for him to skip any further medical evaluation. If you have no further problems, no unnecessary dollars will have been spent and everybody’s happy. If you die, that’s terrible and all, but nobody reading the records will be able to fault him for doing what he did (or rather, for not doing what he didn’t). So it’s a win-win.

This is another reason for routinely reviewing your health records. In an era of covert rationing, you can protect yourself by not exposing your doctors to the ever-present temptation to “spin” the records. (Some doctors are regular DJs.) If your doctor knows you are going to read whatever he puts down, he’s a lot less likely to color the story to your disadvantage.

Indeed, for this very reason, DrRich would be especially suspicious of doctors who refuse to give you copies of your own health records.

Posted in General Rationing Issues | 3 Comments »