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!

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More on Predatory Guidelines

May 6th, 2008 by DrRich

The Wall Street Journal Health Blog informs us that on Saturday last, participants at an American Psychiatric Association symposium apparently castigated the new American Heart Association guidelines on the need to do cardiac pre-screening of children with ADHD. (See DrRich’s previous posting on predatory guidelines, and on the new AHA recommendations.)

A pediatric psychopharmacologist from Harvard (DrRich wonders if any such exist anywhere else) named Timothy Wilens insisted there is no evidence that medication for ADHD causes sudden death. He referenced a recent report in the New England Journal of Medicine showing that the risk of sudden death in children on ADHD drugs is only 0.2 to 0.5 per 100,000 patient years, compared to a risk of 1.3 to 8.5 per 100,000 patient years in athletes under 18. Wilens jokingly suggested that perhaps “Parents should get an EKG for their child before yelling at them.”

Wilens then reluctantly admitted that at Harvard, the cardiac pre-screening recommended by the AHA has already been instituted in order to avoid legal problems.

So, by this graphic example, even when imposed guidelines are clearly believed to be completely unnecessary, even when that belief is strongly supported by published statistical evidence, and even when the guidelines have been promulgated in a demonstrably predatory manner that is more likely an invasion of professional turf than a protection of patients, guidelines are guidelines and must be obeyed.

We can fully expect to see many more examples of predatory guidelines, dueling guidelines, and all manner of other guidelines reflecting utter anarchy. Why? Because the manufacture of guidelines works.

DrRich rests his case.

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Is Guideline Tyranny Causing Guideline Anarchy? (Part II)

May 2nd, 2008 by DrRich

Part I, The Tyranny of Guidelines, can be seen here.

Part II - The Anarchy of Guidelines

Once doctors have been successfully taught that medical guidelines are not really “guidelines” at all, but rather are specific directives with which they must fully comply, it follows that if you are a healthcare group or organization with an agenda, the thing you need to do is to manufacture guidelines that will direct doctors to do whatever it is that most benefits you.

Getting the guidelines to say what you would like them to say is easier to accomplish than one might think. While the practice of guideline-development is ostensibly a highly scientific endeavor that ought not to admit much bias, in truth and to a remarkably large extent it is a political activity.

The more the outcome of a particular guideline-development process is non-deterministic - that is, the more it is capable of being influenced by the personal, political, professional or fiscal agendas of the guideline developers - the more likely it is that you may find competing interest groups devising different sets of guidelines for the same thing. This process, which DrRich believes is only beginning, will eventually create an anarchy of guidelines. Within this anarchy, one can already discern several categories.

Category 1: Dueling Guidelines:

Example: Pharyngitis. Dr. Centor (also affectionately known as DB) is a widely recognized expert on treating pharyngitis, and he has written both on his blog and in the peer-reviewed medical literature on this topic. DB has also written about the many sets of guidelines that have been produced around the world for treating pharyngitis. In regard to 10 sets of guidelines (10!) that were developed by different groups of experts in the United States and Europe, DB notes that the various sets of guidelines show “minimal agreement.” So, for instance, guidelines developed in the United States (where most medical experts receive financial support from industry in one way or another) recommend antibiotics frequently in patients with sore throats, whereas in most sets of guidelines developed in Europe (where keeping costs down is arguably a more important consideration among the medical experts), antibiotics are almost never recommended.

DB further observes that “the 10 guideline groups did not agree on which [medical] articles to include in developing their guideline. More important, these guidelines demonstrate that all guideline committees start with implicit biases. . .The truth about guidelines is that they are molded though the value structure of the panel members.”

Example: Prostate Cancer Screening. DB has also pointed us to this example. The American College of Preventive Medicine (ACPM) concludes that medical evidence to date does not support routine prostate-specific antigen (PSA) screening. This negative opinion on PSA screening is generally supported by the American Academy of Family Physicians and the American College of Physicians. Routine screening, these groups say, may actually produce more harm than good (since false positive PSA levels are common and often lead to unnecessary procedures, and early treatment of prostate cancer often does not translate to improved survival). On the other hand, guidelines from the American Urological Association and the American Cancer Society strongly recommend routine PSA screening, since early detection of prostate cancer clearly saves many lives.

The pattern seen here is readily explainable: General medical practitioners and preventive medicine specialists will tend to give more weight to the overall dollar costs of screening, and to the cost of unnecessary medical procedures that invariably follow from “false positive” screening results. These groups will tend to require strong evidence showing overall benefits to a population before endorsing widespread screening. On the other hand, the groups who get paid to do the screening, or to do the procedures generated by the results of screening, or whose funding is related to the overall incidence of the disease being screened for, will always tend to favor widespread screening.

It is important to note three things here. First, both interest groups are making legitimate points. On one hand, widespread screening will be costlier for society, and may not demonstrate an improvement in overall outcomes across the population. On the other hand, widespread screening will certainly save the lives of many individuals whose cancer will be caught at a treatable stage.

Second, neither group is being completely altruistic here, but instead have produced guidelines that serve their own interests. Specialists who do procedures have a lot to gain by screening policies that generate more procedures. On the other hand, the remuneration for generalists (and preventive medicine specialists) is increasingly tied to cost savings, and to NOT referring too many of their patients to expensive specialists.

Third, both interest groups are comprised of respected experts who use “evidence-based medicine” to reach their conclusions. Everybody in this picture can (and does) passionately support their guidelines as being firmly founded on scientific processes.

Category 2: Predatory Guidelines

Example: Screening of ADHD children. Just last week the American Heart Association (whose physician members tend to be very procedure-oriented - and some might say avaricious - cardiologists) released unsolicited guidelines, recommending the pre-screening of children who have ADHD by a careful cardiac evaluation, including an ECG, before placing them on stimulant medication.

The reason for these new guidelines is that stimulant medication in rare individuals with previously undiagnosed cardiac disease can be dangerous. (So can running on the playground, but nobody is yet recommending cardiac screening before letting kids play.) ADHD today is a very common diagnosis (indeed, it almost seems as if being a boy is now a disease, for which drug therapy is usually required), and routine screening prior to therapy would be extremely expensive both in direct costs, and in the indirect costs related to false positives. Predictably, pediatricians have reacted somewhat skeptically to the AHA’s new guidelines, and the American Academy of Pediatrics (AAP) is asking pediatricians to wait while they scramble to make a formal response.

Members of the AAP recognize, perhaps only subliminally, that the AHA has made a power play here. A powerful interest group with its own agenda has reached onto the AAP’s turf, and has directed AAP member physicians - through the authority of formal guidelines - to change their behavior in a way that may or may not benefit patients, but that will surely benefit members of the AHA. The pediatricians who DrRich knows tend to be kindly, mild-mannered diplomats, in distinct contrast to many of the aggressive cardiologists he knows (and thrives among). So it remains to be seen whether the AAP will respond to this arrogant invasion of their turf with their own set of guidelines. But the non-confrontational idiosyncrasies of pediatricians aside, it is easy to see how “dueling guidelines” could be a natural result of predatory guideline actions like the one taken here by the AHA.

Example: Metabolic Syndrome. In 2005, the American Diabetes Association (ADA) released a stunning statement announcing that metabolic syndrome - to that moment a beloved child of the ADA - does not exist!

Metabolic syndrome is a set of conditions related to insulin resistance that greatly increases the risk of cardiovascular disease. It was initially described by a noted diabetes specialist, and for years remained in the purview of diabetologists. But then, in the late 1990s our friends at the AHA (who seem to be early adopters of predatory guidelines) became very interested in metabolic syndrome, and launched their own guidelines addressing it. Unable to compete with this much larger and much more powerful organization for “ownership” of metabolic syndrome, the ADA finally adopted the unusual tactic of declaring the condition nonexistent. (Those who do not understand why it is important for such organizations to retain ownership of various medical conditions do not understand fund raising.)

Today if you go to the AHA website you will find detailed guidelines on the diagnosis and management of metabolic syndrome. On the ADA website, which used to be loaded with information on metabolic syndrome, all you’ll find is their sad statement saying it doesn’t really exist after all. Patients who formerly had metabolic syndrome are now considered by the ADA to have “pre-diabetes,” which (because this sounds a lot more like a condition they ought to be in charge of rather than a bunch of heart doctors) they hope will place these patients back squarely onto their turf. But thanks largely to the skilled use of predatory guidelines by the AHA (of which DrRich is a proud member), the “metabolic syndrome” terminology has taken deep root in the medical community at large, and is not likely to go away.

Category 3: Industry-driven Guidelines

Industry does not get to create medical guidelines, much to its chagrin, but it has certainly recognized the practical conversion of “guidelines” to “ironclad rules,” and accordingly, is rapidly learning to influence the guideline-development process.

The pathway for doing so looks something like this: a) design a randomized clinical trial that will show that the use of your product substantially improves the outcome of some subset of patients, b) engage key medical thought leaders in the design, management and publication of the trial, c) showcase the results of the trial at major medical meetings, d) petition the guidelines committees of the appropriate medical organizations (aggressively guidelines-oriented organizations, like perhaps the AHA, are especially valued) to incorporate your product into revised guidelines. (If you’ve recruited your medical thought leaders wisely, they will be in a position to influence those guideline committees.)

DrRich may point out examples of this technique in future posts. Suffice for now to say that designing a clinical trial that has a very high probability of showing what you want it to show (step “a” in the process above), is often not particularly difficult. By their nature, randomized clinical trials do not eliminate bias (as many believe), but instead, allow the designers of the trial to control the bias, and thus to tailor the study to yield the desired results. Companies that make medical products figured this out a long time ago.

(The ability to bias the “evidence” is just one of the things that makes “evidence-based medicine” so very intriguing to anyone interested in the nature of objectivity. Or, it goes without saying, to anyone interested in covert rationing.)

Where Will the Anarchy of Guidelines Lead?

DrRich could go on and propose more categories of anarchical guidelines, but this post is already too long, and it is time to get to the point.

Regular readers will already know were DrRich is going with all this. To a healthcare system whose every pore is infused with the need to ration covertly, anything that stirs up anarchy, chaos and confusion can become a great friend. Such things keep doctors (the engines of healthcare spending) completely off balance.

Doctors know they must follow the guidelines or be damned, but when slogging through an anarchy of guidelines, which guidelines should they follow? Somebody, they will eventually plead, needs to bring some kind of order from all this chaos. And of course, a central authority will immediately answer the call, only too ready and willing to put things right.

The overall program, then, looks like this:

1) Make doctors understand that guidelines must be obeyed in every particular. (Done.)

2) Realizing that doctors think this way, various interest groups will begin promulgating numerous guidelines of their own, ultimately leading to “guideline anarchy,” and placing actual practicing physicians into a completely untenable position. (This process is beginning.)

3) Finally, everyone will acknowledge the need for some central authority to step in, sort through the manifold sets of guidelines, and select those (or assemble brand new ones from the parts) that will now become the “official” Guidelines Which Must Be Obeyed. This step is the one that will allow the central authority to select or tailor the guidelines that meet its own special interest (i.e, covert rationing), and to do it in a way that is not overtly heavy-handed, but rather, that rescues order from chaos.

4) Doctors, by this point beaten into submission, will not rail against the externally imposed guidelines, but rather, will be thankful that the central authority has brought wonderful clarity at last.

So once again, covert rationing acts on the system to disrupt its equilibrium; but as always, entropy eventually will become maximized and a new state of equilibrium will be reached. DrRich is no oracle, just a student of thermodynamics.

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