Health care tyranny

Dr. Richard N. Fogoros, M.D., a former professor of medicine who spent over 20 years as a full-time clinical cardiologist and medical researcher, has been thinking along similar lines to last week’s government surveillance Scarlet D story, with a third party monitoring and compelling our behaviors and healthcare decisions, and those of our doctors. In a two-part series, he cuttingly described why consumers and healthcare providers need to get serious about understanding what is happening with “evidence-based” guidelines and performance measures.

In Part One, he begins by explaining the original purpose behind clinical care guidelines, and how they’ve turned into something entirely different. No longer are they about sound evidence-based medicine, they’ve become something far more sinister — a way to coerce doctors and consumers into behaving how the government or insurer or special interest decides — with profit-driven motives. Yet, the public largely assumes that everything they hear about them is true: that they are measures of “quality” of care and sound evidence, and that if everyone followed them, then better health and lower healthcare costs will follow. As he writes:

Is Guideline Tyranny Causing Guideline Anarchy? (Part I)

The original idea behind medical guidelines was to provide (oddly enough) a guide to physicians in caring for patients with a particular medical problem. That is, they suggested a generally preferred approach to medical care in view of current medical evidence, but did not attempt to dictate care in all cases. Medical guidelines were to serve as a roadmap which, while usually suggesting a favored route from point A to point B, always understood that that for individual patients, some alternative route might be preferred or necessary...

It was simply assumed that in applying such guidelines clinicians would continue “integrating individual clinical expertise with the best available external clinical evidence from systematic research.” That is, guidelines were supposed to serve as a touchstone for doctors attempting to tailor the best available current evidence to the care of their individual patients.

It goes without saying that medical guidelines are actually not being used in this way today. Under a healthcare system where controlling the behavior of physicians (in a vain attempt to control costs) is Job One, “guidelines” are treated as a set of unalterable rules - as definitive steps that must be followed in all cases, without exception; and that, if taken, will yield that which is defined as high quality medical care, and if not taken, will yield that which is defined as low quality medical care. Once quality is defined as compliance with guidelines, then “physician report cards” based on such compliance can be made available to the public, and can be used to steer patients to the “high quality” doctors and away from the “low quality” ones. Lately, the highly popular gambit of Pay for Performance assures that doctors are explicitly rewarded (like trained seals) for following whichever of the sundry lists of guidelines is preferred by the payer of record, to assure excellent quality (and, incidentally of course, to reduce cost)...

He goes on to example the lack of transparency behind the authorities who wrote the most recent guidelines issued from Medicare. “It matters not,” he said, “whether strictly following these guidelines might even have harmful unintended consequences for patients.” That’s because:

The guidelines, once designated by various insurers or the feds as being “the” guidelines, must be obeyed. (And if it turns out that the guidelines simply cannot be obeyed, say, due to their sheer ungainliness, then large masses of doctors can be threatened with lawsuits for non-compliance, if not for accessory to murder.) Guidelines treated in this manner clearly violate the original intent of evidence-based medicine in general, and of medical guidelines in particular...

In Part Two, he gets into the nitty gritty of the corruption behind clinical guidelines and, hopefully, will help readers better realize how controversial the evidence and efficacy behind many guidelines are within the medical profession — as in keeping health indices (BMI, cholesterol, blood sugar, etc.) in some ideal range or treating risk factors as diseases. This is must reading! [As usual, click on headline link to full article.]

Is Guideline Tyranny Causing Guideline Anarchy? (Part II)

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, Dr. Fogoros identified several specific problems. First, is “Dueling Guidelines,” with each special interest or group of experts (most medical experts in the U.S. developing guidelines receive financial support from industry, he points out) coming up with their own set of guidelines and then fighting to make their’s the official one. There are 10 different guidelines for treating pharyngitis, alone, all developed by different groups of experts and none agreeing. Another example of dueling guidelines he describes is prostate cancer screening and how neither of the groups arguing for and against “is being completely altruistic here, but instead have produced guidelines that serve their own interests.” We’ve seen numerous examples of guidelines issued by the various interest and trade groups differing considerably from the evidence, such as provided by the U.S. Preventive Services Task Force or Cochrane Collaborative reviews (obesity, childhood obesity, healthy eating for cancer or heart disease prevention, etc.).

Screening tests and health risk assessments can be along the lines of seek and you shall find, and have become popular ways to increase the rosters of people labeled with some health problem and stimulate medication prescriptions and other interventions. Which brings us to the second problem category he identified as “Predatory Guidelines.” He examples the screening of ADHD children and new recommendations from the American Heart Association to do EKGS on all children — the controversy is well worth reading and reminds us that what may sound good may not actually benefit of patients, while “they will surely benefit members of the AHA.”

His second example is metabolic syndrome being heavily promoted by the American Heart Association, while the American Diabetes Association is pushing for a syndrome called “prediabetes.” Its a turf war and an attempt to medicalize numbers, as he writes:

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! ... 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.

His third category in misguided guideline tyranny are “Industry-driven Guidelines.” While industry doesn’t get to create actual medical guidelines, he says, it has learned to influence the guideline writing process. As he writes:

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.)...

Suffice for now to say that designing a clinical trial that has a very high probability of showing what you want it to show, 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.

As he said, the ability to bias the evidence is just one of the things that makes ‘evidence-based medicine’ so challenging and why JFS so often covers the importance of understanding bias in research, the misuses of epidemiology and what makes a fair test.

None of this would matter as much if guidelines were still guidelines and doctors and consumers could take them in to consideration as they chose, rather than mandates and performance measures for both doctors and the public. Where all of this is heading is where it gets troubling, as the government and insurers work to create nationalized managed care, under which both consumers and healthcare providers will be forced to comply to a central authority. He says the overall program 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.

And the public will believe that government and insurers know best — better than they or their doctors — and are looking out for their best interests, too.