“Evidence-Based Medicine”: Corporate Medicine’s Corrupted Instrument.

Only when the law weds the bedrock principles of medical ethics to corporate medicine’s quest for standardized “evidence-based” practices will America see the emergence of “patient-centered” medicine.

A Note of Clarification: Since the original publication of this article, a number of readers seem to have assumed that Vaccines are one of the “evidence-based” medical practices it critiques — and that the author is endorsing the anti-vaccine campaigns across the United States. To be clear, the author fully grasps the critical importance of vaccination to protecting public health from devastating infectious disease epidemics. Therefore, though it is critical to consider whether vaccine composition and scheduling can be improved to prevent complications in at risk patients, the author considers the complications associated with vaccination as being the unavoidable side-effects of an absolutely necessary public health policy.

The idea of “Evidence-based medicine” is probably one of the most successful marketing tools ever commandeered by a corporate entity.

In its purest form “evidence-based medicine” is a clinical exercise in the scientific method — an attempt to make the “art of medicine” as scientific and “standardized” as possible.

The medical establishment, today, takes pride in practicing “evidence-based medicine” — so much so that this phrase is synonymous with good medicine in the eyes of the profession and the public.

Highly decorated physicians, professional societies and glitzy hospitals all describe their gold-standards as being “evidence based” — and they work hard to gather, or create, the “evidence” needed to sell their wares to insurers and patients.

The idea of “evidence-based” medicine is that any particular practice, policy, drug or device is kosher if statistics points to its safety and efficacy in accomplishing the stated therapeutic goal in the majority of patients. In that sense, “evidence-based” medicine is a utilitarian process.

This all sounds good. Until one realizes that this approach does not address a very serious question: What happens to those patients who do not benefit in the scheme of “evidence-based” practice? And, more specifically, is the the cost of the so-called “evidence-based” practice, to those who do not benefit, ethically justifiable?

In healthcare, the cost to a patient is not just financial but can be, more importantly, quantified in terms of the complications or side-effects wherein a patient’s condition is made worse or death is accelerated by the healthcare system.

Of course elimination of complications and the side-effects of therapy is the “holy grail” of medicine. This idea is captured in the ancient dictum of “first, do no harm” all physicians are sworn to. But in the year 2017, this sacrosanct directive seems to have become nothing more than a marketing cliche for corporate medicine and its guardians.

In reality, today’s “evidence-based medicine” does not ask the ethics question about those who do not benefit, who are made worse or who die, with anywhere near the necessary urgency needed to protect the precious lives of those at risk.

In fact, when patients are harmed or die because of a practice, the guardians of the medical establishment point to their “evidence” and argue that the practice was based on “good evidence” — in this contorted way of thinking, the damage done to any particular patient, “though unfortunate”, is the acceptable cost of practicing “evidence-based” medicine.

But when the patient or his/her advocate(s) object to this idea that the harm done ought to be accepted or is simply unfortunate — they are typically labeled, by a vast number of physicians and their managers, as being “crazy”, “unhinged” or “uneducated” . This, I know as a matter of fact, as a physician.

But the real trouble is that when corporate forces remove stringent ethical restraint from “evidence-based” practice, it becomes nothing but a marketing tool to make money in a way that “benefits the majority” of consumers/patients — irrespective of its cost to the minority subsets of people it might be harming.

Even worse is that as novel, but ethically unhinged, “evidence-based” practices are accepted as “standards” they acquire a powerful legal shield, impenetrable by the ethics argument — or even by the heart-wrenching personal narratives of morbidity or mortality from individual patients and their loved ones. Add generous reimbursements from insurers to such legally defensible “standard” practices and you have corporatized harm to subsets of patients — dressed up in a very nice and “acceptable” package.

After an “evidence-based” practice is standardized, comes the sliding scale of patient selection for these practices. As long as the sizable reimbursements are flowing into the cofers of physicians and hospitals, and so long as the clinician can hide behind his/her standard of care defense when harm is done, there is no end to profit driven practice patterns.

You might wonder what some of these corrupted practices are in contemporary medical practice. Here are a few prominent examples of ethically lax, “evidence-based” medical practices: Cosmetic surgical procedures, LASIK eye surgery, Gastric bypass surgery, Resection of the uterus, ESSURE birth control, pelvic mesh implantation, tumor morcellation, simultaneous surgery, minimally invasive heart surgery, robotic surgery, minimally invasive heart valve replacement, Ventricular assist devices for heart failure, screening colonoscopy, etc.

There is a plethora of ethically suspect standard practices, or ones that are offered to patients too liberally, that prominent physicians and hospital offer, dressed up as “evidence-based” gold-standards. All you need to do is drive up a major highway interstate and read the billboards — there is some pretty sharp advertising going on. But, make no mistake, it’s the lucrative bottom line that is driving it all — not the ethical practice of medicine.

For the corporate side of medicine, the beauty of lax ethical restraints on “evidence-based” practice is that it allows increasing numbers of profitable practices to quickly evolve — the downside is that such practices will unjustifiably maim and kill unsuspecting patients who will then have no legal recourse.

In effect, “evidence-based” medicine, unhinged from ethics, has become nothing but a well-oiled propaganda machine for corporate medicine’s primary goal of creating profitable “service-lines”. And these “service-lines” are the direct conduits draining our health insurance investments.

Is there a solution to this problem the overt corporatization of American medicine has created? I think, yes.

What patients need is for all standard medical practices and policies to not only be “evidence-based”, but also “ethics-based” — especially in considering their ramifications for those who do not benefit or are hurt by the practice. In fact, the latter should always strictly guide and inform the former in a stringent fashion.

Don’t take me wrong, I know that there are plenty of highly skilled physicians who practice “evidence-based” medicine with a constant eye on the ethics of their conduct. But, unfortunately, for every good and ethical physician out there, there are many who are captured by ego and money — and this latter type of doctor, no matter how skilled, will do harm.

So, how can strictly ethical standards be established in medical practice on a systemic level and using the force of the law?

I believe that the answer is simple and legally tenable.

Every physician’s professional conduct is bound, as an expected standard, by the American Medical Association’s Code of Medical Ethics. And “breach of standard” is the yard-stick by which the courts evaluate professional negligence.

In fact, just like any standard medical practice is subject to a set of principles, so is the medical ethical conduct every patient deserves in his/her handling by physicians and the healthcare system. These ethical principles are: “beneficence”, “non-maleficence”, “Justice” and “Autonomy”.

If a physician’s practice can be demonstrated by expert bioethicists to violate any one of these principle of medical ethics, when treating a patient, he/she is guilty of breaching a standard of care — and, by definition, medical negligence has occurred.

In the end, we are unlikely to eliminate either medical utilitarianism or the corporate influence demanding the “evidence” and propaganda it needs to market novel products. Nor, perhaps, should we — because fighting to eliminate utilitarianism in medicine would likely bring progress and innovation to a grinding halt.

But, I firmly believe that if expert medical ethicists are formally brought into the litigation process to evaluate standards of medical conduct when patients claim harm, the force of legal liability can be unleashed on the corporate machine — not to destroy it, but to force it to adopt only the type of “evidence-based” medicine that is solidly guided by the standard of ethical conduct expected of all healthcare providers.

What I’ve proposed here is a legal theory, of course. But I’m nearly certain that if a few good plaintiff’s attorneys start to use the expertise of master bioethicists, “evidence-based” medicine can also become ethically-sound medicine.

Only when the law weds the bedrock principles of medical ethics to corporate medicine’s quest for standardized “evidence-based” practices will America see the emergence of truly “patient-centered” medicine.