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Because The Survival Of The Current Patient Compliance Concept Endangers Patients

But more about that later.

Understanding both the catastrophic risk and the seemingly inexplicable persistence of the patient compliance model¹ is facilitated by first considering a parallel case of another incorrect medical hypothesis.

There Will Be Blood: Bloodletting As A Model For Adherence

While mistaken beliefs in many fields of knowledge can impair or imperil  individuals, the calculus of  the danger represented by erroneous medical concepts can be especially evident. Prescribing an ineffective  treatment, for example, can be a death sentence to a patient with a serious disorder. Some  treatments that were once widely accepted, in fact, are now known to be toxic  even to  otherwise healthy individuals.

Nonetheless, detecting and rooting out such errors has frequently proved to  be an  extraordinarily arduous and prolonged task.

Medical theories and practices that now appear blatantly  fallacious and even ludicrous were often founded on logical premises, were seemingly congruent with the available evidence, and were supported and used by competent, careful, and conscientious practitioners.  Many treatments that we now know were disastrous wrong were not the work of quacks, greedy producers and sellers of worthless or poisonous potions, charismatic charlatans, sociopaths, or religious fanatics. In fact, the most widespread and enduring – and therefore the most dangerous – mistaken medical methodologies were those formed and held by clinicians acting thoughtfully and in good faith.

Consider bloodletting, as described in Wikipedia:²

Bloodletting (or blood-letting) is the withdrawal of often considerable quantities of blood from a patient in the belief that this would cure or prevent a great many illnesses and diseases. It was a tremendously popular medical practice from antiquity up to the late 19th century, a time span of almost 2,000 years. The practice has been abandoned for all except a few very specific conditions. It is conceivable that historically, in the absence of other treatments for hypertension, bloodletting could sometimes have had a beneficial effect in temporarily reducing blood pressure by a reduction in blood volume. However, since hypertension is very often asymptomatic and thus undiagnosable without modern methods, this effect was unintentional. In the overwhelming majority of cases, the historical use of bloodletting was harmful to patients.

Bloodletting was founded on a logical, albeit inaccurate, notion:

“Bleeding” a patient to health was modeled on the process of menstruation. Hippocrates believed that menstruation functioned to “purge women of bad humors”. Galen of Rome, a student of Hippocrates, began physician-initiated bloodletting.³

And, scientific discoveries supported it.

The popularity of bloodletting in Greece was reinforced by the ideas of Galen, after he discovered that veins and arteries were filled with blood, not air as was commonly believed at the time.

Bloodletting was not cavalierly formulated. Rather the associated theoretical explanations became increasingly sophisticated.

Galen created a complex system of how much blood should be removed based on the patient’s age, constitution, the season, the weather and the place. Symptoms of plethora were believed to include fever, apoplexy, and headache. The blood to be let was of a specific nature determined by the disease: either arterial or venous, and distant or close to the area of the body affected. He linked different blood vessels with different organs, according to their supposed drainage. For example, the vein in the right hand would be let for liver problems and the vein in the left hand for problems with the spleen. The more severe the disease, the more blood would be let. Fevers required copious amounts of bloodletting.

Bloodletting was widespread, and became one of of those principles so obviously true that it was integrated into common sense.

The Talmud recommended a specific day of the week and days of the month for bloodletting, and similar rules, though less codified, can be found among Christian writings advising which saints’ days were favourable for bloodletting. Islamic medical authors too advised bloodletting, particularly for fevers. The practice was probably passed to them by the Greeks; when Islamic theories became known in the Latin-speaking countries of Europe, bloodletting became more widespread. Together with cautery, it was central to Arabic surgery; the key texts Kitab al-Qanun and especially Al-Tasrif li-man ‘ajaza ‘an al-ta’lif both recommended it. It was also known in Ayurvedic medicine, described in the Susruta Samhita.

Bloodletting Machine Mechanism

Not everyone, however, bought into the idea. Some, in fact, began demonstrating that, at least in some classes of cases, bloodletting was valueless.

William Harvey disproved the basis of the practice in 1628, and the introduction of scientific medicine, la méthode numérique, allowed Pierre Charles Alexandre Louis to demonstrate that phlebotomy was entirely ineffective in the treatment of pneumonia and various fevers in the 1830s.

By the mid-1800s, there was substantial empirical evidence this method didn’t work in a number of specific cases. These findings not only  failed to stop the practice but likewise failed to slow its growth.  Indeed, bloodletting enjoyed a surge of popularity during this period with it being touted as a potential treatment for almost every imaginable ailment.

…  in 1840, a lecturer at the Royal College of Physicians would still state that “blood-letting is a remedy which, when judiciously employed, it is hardly possible to estimate too highly”, and Louis was dogged by the sanguinary Broussais, who could recommend leeches fifty at a time.

Bloodletting was used to treat almost every disease. One British medical text recommended bloodletting for acne, asthma, cancer, cholera, coma, convulsions, diabetes, epilepsy, gangrene, gout, herpes, indigestion, insanity, jaundice, leprosy, ophthalmia, plague, pneumonia, scurvy, smallpox, stroke, tetanus, tuberculosis, and for some one hundred other diseases. Bloodletting was even used to treat most forms of hemorrhaging such as nosebleed, excessive menstruation, or hemorrhoidal bleeding. Before surgery or at the onset of childbirth, blood was removed to prevent inflammation. Before amputation, it was customary to remove a quantity of blood equal to the amount believed to circulate in the limb that was to be removed.

Leeches became especially popular in the early nineteenth century. In the 1830s, the French imported about forty million leeches a year for medical purposes, and in the next decade, England imported six million leeches a year from France alone. Through the early decades of the century, hundreds of millions of leeches were used by physicians throughout Europe.

Bloodletting persisted into the 20th century and was even recommended by Sir William Osler in the 1923 edition of his textbook The Principles and Practice of Medicine

The question becomes, why did bloodletting  persist for 2,000 years even though for all but a handful of cases it provided no physiological advantage in the fight against disease? As it turns out, one need not invoke conspiracy theories about nefarious plots carried out by the Leech-sellers Guild and the physicians to fool the public to explain the longevity of bloodletting.

One reason for the continued popularity of bloodletting (and purging) was that, while anatomical knowledge, surgical and diagnostic skills increased tremendously in Europe from the 17th century, the key to curing disease remained elusive, and the underlying belief was that it was better to give any treatment than nothing at all. The psychological benefit of bloodletting to the patient (a placebo effect) may sometimes have outweighed the physiological problems it caused. Bloodletting slowly lost favour during the 19th century, but a number of other ineffective or harmful treatments were available as placebos—mesmerism, various processes involving the new technology of electricity, many potions, tonics, and elixirs. [Emphasis mine]

And, there are a limited number of cases in which bloodletting is helpful:

In the absence of other treatments, bloodletting actually is beneficial in some circumstances, including the fluid overload of heart failure, and possibly simply to reduce blood pressure. In other cases, such as those involving agitation, the reduction in blood pressure might appear beneficial due to the sedative effect.

Summary: Comparing Bloodletting And Patient Compliance

Let’s review:

Bloodletting is a practice dating back to Hippocrates which was, until 200 years ago when it began to fall out of favor, the standard of care for a wide scope of disorders throughout the civilized world. A multitude of explanatory theories and methodologies of implementation were devised. Skilled physicians, surgeons, and barbers, aided by cleverly designed mechanical devices and leeches (biological machines), became ever more efficient in performing the procedure. That the process could not be shown to result in positive outcomes in the overwhelming majority of cases was explained away or ignored, as was the scientific evidence that the process was therapeutically ineffective in given disorders, perhaps in the belief that it was better to give any treatment than nothing at all.

Treatment adherence is a model dating back to Hippocrates which continues to be the standard of care throughout the civilized world. A multitude of explanatory theories and methodologies of implementation have been devised. Skilled physicians, other clinicians, and researchers, aided by cleverly designed mechanical devices, have become ever more efficient in performing a set of compliance enhancement procedures (such as reminding the patient to take a pill, educating the patient, packaging all of a patient’s medication in dose packs, etc.). That the process has not been shown to result in significant improvements in the overwhelming majority of cases has been explained away or ignored, as has the scientific evidence that certain specific procedures are ineffective, perhaps in the belief that it is better to try to improve compliance by any means available than do nothing at all.

On the other hand, I can find no evidence that anyone has suggested that patient compliance can be enhanced by the use of leeches.

The Potential Risk Of Bloodletting And Patient Compliance

The danger of bloodletting was not, except in a small number of cases, death by exsanguination. Instead, the harm done to centuries of patients was in the form of what economists call opportunity cost.  If, for example, one purchases a car for $30,000, the opportunity to invest that  $30,000 in ones next best choice, say starting ones own business, is lost.

During the time that bloodletting was in favor, it was the dominant investment target for available intellectual, financial, and medical professional capital. Consequently, the opportunity to use those resources to develop and implement other, perhaps more effective, therapies was lost. Every day that the practice of bloodletting slowed the development of more effective therapies was a day treatment outcomes were worse than they could have been – that means some patients died, suffered incapacities, recovered more slowly, and, at best, endured the pain and cost of treatment needlessly.

Similarly, as long as intellectual, financial, and medical professional capital are devoted to the current patient compliance paradigm, developing and implementing other, perhaps more effective, alternatives is unlikely. And, every day that the current patient compliance paradigm slows the development of more effective enhancement of treatment implementation is a day treatment outcomes are  worse than they could have been – that means some patients die, suffer incapacities, recover more slowly, and, at best, endure the discomfort, inconvenience, and cost of treatment needlessly.

Incorrect, ineffective patient compliance theory is not  trivial  – it is literally a matter of life and death.

And that is why I  resort to posts like this with accurate but  admittedly sensationalist titles like “Why Today’s Treatment Adherence Paradigm Must Be Destroyed.”

Coming In Part 2

• A brief exposition on my contention that the patient compliance paradigm is ineffective and wastes resources yet doesn’t have the good grace to die on its own.
• The  lack of enthusiasm for the contemporary concept of patient compliance  paradoxically coupled with continuing use of that system as a basis for research and interventions.
• The Showdown: My dismissal of treatment adherence compliance as a system capable of generating effective compliance enhancements could be wrong, but I’ve found almost no support for the opposing view. I maintain that, at this point, those continuing to pursue research, offer programs, invest in a Chair in Patient Adherence to Drug Therapy, … have the intellectual responsibility to present their arguments for staying the course or indicate the changes they  intend to institute.
• Possible alternatives to patient compliance.

Credit Due Department:
The photo atop this post, ”4 Seasons Hotel Implosion,” was taken by Mozambique – Moments.

1. For the purposes of this post, “patient compliance model,” “treatment adherence paradigm,” and similar terms refer to any  ideas explicitly set forth by or implicit to patient compliance as  a system of thought rather than a simple statistic.  For example, the calculation of number of doses taken as prescribed divided by the total number of doses prescribed is a patient compliance statistic; the idea that noncompliance is an entity that causes patients to fail to take their medications as prescribed (not unlike miasma was thought to cause the Black Death) and that can be addressed by a simple response such as patient education is part of the “treatment adherence paradigm.”↩
2. All references, unless otherwise specified, are from Wikipedia↩
3. Those who scoff at the “logic” employed by  Hippocrates and his followers to derive this premise are urged to consider that in 2009, many and perhaps most adults still believe in the disproved idea that sweat rids the body of toxins.↩