The Covert Rationing Blog

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.

Posted in Guidelines, Abuse of

3 Responses to “Is Guideline Tyranny Causing Guideline Anarchy? (Part II)”

1. pcb wrote on 05/6/08 at 8:15 am :

   Dr. Rich,

   good stuff.

   I encourage you to check out this paper when you have a chance, very pertinent to your post(I couldn’t find an online link, sorry):

   External validity of randomized controlled trials in COPD .
   Respiratory Medicine , Volume 101 , Issue 6 , Pages 1313 - 1320
   J . Travers, et.al

   To quote from the conclusions:

   “The major COPD RCTs on which the GOLD treatment guidelines are based may have limited external validity. Over 90% of the COPD subjects in the community who were taking medication, did so on the basis of RCTs for which they would not have been eligible.”

   I find this fascinating. Over 90% of real patients in the community with spirometry diagnosed COPD would NOT BE ELIGIBLE for the trials used to set the guidelines for treatment of COPD.

   Certainly backs up some of your ideas above.

2. DrRich wrote on 05/6/08 at 8:32 am :

   pcb,

   Thanks for this. Companies seem to know that if they select small, special subsets of patients for their randomized trials, who are very likely to respond positively to their products and thus yield a successful RCT, then once the study is published, doctors (and even guideline developers) are very likely to extrapolate the results to ALL patients. Works every time it’s tried.

   Rich

3. dougie wrote on 05/13/08 at 11:24 pm :

   You write:
   “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.”
   Not so fast. Where is the evidence that anyones life will be saved by these procedures?

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