Science Has No Conscience!

by J. David Kocurek, Ph.D.

What? It’s really not too hard to understand. When practiced by a well-established set of rules, science is simply the means to advance knowledge and understanding. The product of a scientific endeavor is neither good, bad nor even indifferent – until human intent determines the outcome.

Fortunately, most “scientists” do have a conscience, but it’s those remaining few without a strong ethical compass that, when driven by unrestrained ego, the rewards of fame and attention, or at worse financial gain, perpetuate harm upon an unsuspecting community. The injury is further compounded to the extreme when those in positions of control and authority misuse a marginal scientific product whether with intent, through ignorance or careless management.

Of course, I’m continuing to address the impact on the quality of patient care, including access, the Infectious Diseases Society of America’s (IDSA) 2006 Lyme disease guidelines are having on Lyme patients. Through my advocacy work with standupforlyme.org in Texas, the number of contacts from new patients and patients abandoned by caregivers who are choosing not to expose themselves to medical board scrutiny are ever increasing. The reason always tracks back to the IDSA whose guidelines are blindly accepted as authority by front line physicians and which form the basis for community standard of care enforced by the medical board.

Much has already been written as to how the guidelines effectively eliminate the disease by making its diagnosis highly exclusionary. The faulty logic and bad science, more commonly referred to in legal circles as “junk science” was readily identified as was the weakest level of evidentiary opinion that emboldened the IDSA to claim the guidelines to be “evidence-based.”

The modern standard of evidence-based medical (EBM) practice that we hear so commonly referred to and its basis deserves some attention in order to understand if or how it varies from traditional medical practice, and to understand what the IDSA is attempting to accomplish. Is the flaw in the method or the execution?

The underlying philosophy of EBM has its roots at least as far back as mid 19th century Paris, and has developed today into its own area of academic study with an abundance of literature and organization resources. Some describe EBM as a paradigm shift, but that contradicts the tenets of its traditional medicine roots as well as the evolutionary development of the modern practice. For these proponents the importance of process adherence exceeds the value of outcome.

Sackett et al in their editorial, Evidence based medicine: what it is and what it isn't [BMJ 1996;312:71-72 (13 January)] succinctly describe EBM in their opening statement, “It's about integrating individual clinical expertise and the best external evidence.” That sounds well grounded. How can one argue with professional proficiency backed with a command of the preeminent research in the field? Isn’t that what has always been expected from the leaders in any field? There really isn’t anything new in EBM when viewed from expectations of traditional practice. It’s simply a systematic method to process patient care decisions.

Compare the eloquent simplicity of the definition above with the complex dissection given in the text Evidence-Based Medicine: A Framework for Clinical Practice [Edited by Daniel J. Friedland, MD, McGraw Hill (1998)]: “The traditional medical paradigm comprises four assumptions:

1. Individual clinical experience provides the foundation for diagnosis, treatment, and prognosis. The measure of authority is proportional to the weight of individual experience.

2. Pathophysiology provides the foundation for clinical practice.

3. Traditional medical training and common sense are sufficient to enable a physician to evaluate new tests and treatments.

4. Clinical experience and expertise in a given subject area are a sufficient foundation to enable the physician to develop clinical practice guidelines.

The new evidence-based medicine paradigm comprises a different set of assumptions:

1. When possible, clinicians use information derived from systematic, reproducible, and unbiased studies to increase their confidence in the true prognosis, efficacy of therapy, and usefulness of diagnostic tests.

2. An understanding of pathophysiology is necessary but insufficient for the practice of clinical medicine.

3. An understanding of certain rules of evidence is necessary to evaluate and apply the medical literature effectively.”

Notice the bias shift from practitioner expertise to reliance on the medical literature. I think I’m reliving the new math and open classroom era when I read this. Pathophysiology is a constant (only the depth of understanding changes) and hopefully that’s what medical education and the literature reflect. It remains the responsibility of the practitioner to maintain contemporary skills, and to do so does require devoting the time to weigh and filter the literature for the best information. Again, nothing has changed except the name of the process. What is called for in EBM is the same process a competent traditional physician practiced by instinct, except in the “paradigm shift” model the responsibility is reallocated toward the literature which itself can bear no responsibility!

Now back to the IDSA guideline question of flawed process or flawed execution. The particular process used can’t escape a large share of the blame because it appears to have been molded to provide desired outcome. Specifically, the authors failed to integrate clinical expertise with the best external evidence. Selective use of clinical experience and literature by preferentially restricting it to information, especially that from members of the author’s own club, that supports the thesis is an unashamed deception within either EBM premise. This is also an elected blemished execution, and so the two areas of focus are inseparably convoluted.

The continued focus on acute phase disease when tens of thousands of late stage or chronic Lyme disease sufferers are known to exist by even the most conservative projections is an execution flaw. It’s an intentional exclusion. The IDSA represents the medical sector that is most responsible for the care and well-being of Lyme disease patients, yet they continue to diminish the disease complex in its most insidious form. As physicians and scientists, why are they not aggressively researching diagnostics and treatments for all tick borne diseases, regardless of disease stage?

If the IDSA and its physician cohort devoted as much time and energy to legitimately working to improve the state of the science in all aspects of the disease, as they do to minimizing its toll on patients and discrediting those clinicians who make every good faith effort to competently treat, would they not be truly fulfilling their mission? The use of evidence-based concepts is merely a sideshow when one attempts to rationalize the IDSA’s motive in approaching Lyme disease. They use it wrongly and deceptively to accomplish some dangerous motive.

I’m still left with the thought that there must be something more valuable than reputation to protect when the IDSA and the guideline authors breach most every code of ethic that must be adhered to for true scientists to advance knowledge for the common good.