It's time to stop the damage caused by today's patient compliance paradigm



Imagine that a manufacturer of state of the art medical devices and the Feds co-funded a $14.2 million multicenter  study to determine the  effectiveness of a newly designed stereotactic laser bloodletting* machine (with optional Facebook connection)  in treating diabetes.

Doesnt it seem likely that a whistle-blower or, failing that, a Senator coming up for re-election, an investigative reporter desperate for a story, a publicity-seeking Attorney General of one state or another, a gadfly shareholder, a do-gooder looking for a cause, or a Ralph Nader wannabe would be loudly decrying the use of public and shareholder monies on a clinical trial of a treatment never shown to be of benefit to patients with this disease despite many, many years of use?

One would, in fact, predict that  congressional committees would be convened, newspaper stories written, blog posts posted, accusations leveled and denied, indictments brought, damage control instituted, scapegoats designated, and heads rolled.

At the least, the medical device company,  the Federal agency that handed over the bucks, and the academic institutions involved would be called upon to justify their choice of investments, i.e., explain why the limited amount of money and skilled researchers were designated to be expended on this project instead of a potentially effective therapy or at least one that has not already proven useless.

The Unacceptable Risk Of The Patient Compliance Paradigm

I contend that  the now dominant  paradigm of adherence to treatment, has,  like bloodletting,  been so unsuccessful for so long (see previous posts: The Tragedy Of Patient Compliance and Patient Compliance So Wrong For So Long)  that continuing to explore the same familiar primrose paths  of the patient compliance model  entails an intellectual responsibility to provide an explicit rationale for taking this tack.

Consider this comparison of bloodletting and patient compliance:

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 patients 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 Damage Done By 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.

Next: Alternatives To the Current Patient Compliance Model

The posts in this sequence have thus far focused on the why the treatment adherence paradigm is ineffective and the danger of its continued use.  The next entry will begin a discussion of possible alternatives to the current model.

Follow-up And Related Posts

A more thorough explication of the need to dismantle and replace the patient compliance system of thought is available on my AlignMap blog at

Why The Treatment Adherence Paradigm Must Be Destroyed:
Part 1 and Part 2

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*For those unfamiliar with the procedure, bloodletting is described in the well done Wikipedia article on the subjectWikipedia article as 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.