Weighing Treatment Options – What Informs Choices?

Sitting in a CEDH-sponsored homeopathy course, I shared the discomfort that many of the allopathically-trained students felt percolating when the instructor admitted to a minimal evidence base; “When it works, it works, and sometimes it doesn’t.”  There was some allusion to the difficulty of standardizing interventions for purposes of a placebo-controlled trial, and reference to the many years of tireless experimentation Hahnemann (the originator of homeopathy) had performed on himself and his students.

I have used homeopathy for years, and consider it for patients when there is a mild complaint deserving of a treatment, but when the benefit of intervention is outweighed by the risk of side effects from medications or even supplements.  I do not maintain that this is an evidence-based practice, and I do not think that this detracts from its utility.  When Ayurvedic and Chinese medicine interventions attempt to conform to the conventional model of safety and efficacy validation, it is almost surprising to see positive results.   Surprising not because I am skeptical about the efficacy of these ancient treatments, but because these modalities employ an individualized assessment of the patient that a trial does not easily accommodate.  Biochemical individuality.

But we have bought into a disease-medication model, driven by the holy placebo-controlled trial.  This is the language that doctors speak, and anything else is considered gibberish.  We work with one-size-fits-all interventions and reduce patients to their indication, or diagnosis.  We tell ourselves that the algorithm works when it is “evidence-based”.  What does this mean when we see that the house of cards has been glued into its position?

In the realm of psychiatry, this slight-of-hand has been well exposed but remains a point of heated contention.  Meta-analyses conducted by Kirsch, et al. have demonstrated the power of the placebo effect in randomized antidepressant treatment trials. Kirsch alleges that the placebo effect alone may account for up to 75% of the treatment effect of active medication exposure.  He further elucidates the notion that an “active” placebo – a placebo that includes an intentional side effect so that it is less distinguishable from an active medication – fuels the already present placebo response, closing the gap with active medication, i.e; “these side effects tell me I’m taking a drug that will help me.”

Kirsch is one of many to expose the 40% of funding to the FDA that comes from pharmaceutical companies, and the fact that, despite registration of studies, data is still manipulated, cherry-picked, and redundantly submitted.  He also supports a claim posited by Fournier, et al. that antidepressants only separate from placebo in the setting of severe depression. However, he observes that this effect is miniscule, at best.  Dedicated prescribers defend their craft by alleging that the homogeneity of these active treatment groups renders the results of these trials useless, and poorly reflective of “real life medicine”.  When real life medicine is informed by publicity of selectively published studies, the effect of belief on results is meaningful.

Of course, this corruption of data and misattribution of benefit to pharmaceutical interventions is not just psychiatry’s problem. The problem is not just with the drug companies and the researchers, but with the whole system — the granting institutions, the research labs, the journals, the professional societies, and the many strands of this complex web. No credible institution is providing the checks and balances necessary to avoid conflicts. Instead organizations seem to shift responsibility from one to the other, leaving gaps in enforcement that researchers and drug companies navigate with ease, and then shroud their deliberations in secrecy.

Two recent pieces have exposed concerns; one quoted above focuses on a prominent medical researcher with ties to Wyeth Pharmaceuticals and the ripple effect of his conflicts of interest in medication and even education and treatment protocols.  The “thicket of entanglements” runs throughout the medical-governmental-industrial complex.  Another focuses on dangerous lessons regarding vested interests such as those learned from the story of Avandia; some 83,000 deaths after its being lauded as a uniquely effective intervention for diabetes mellitus.

Over a year-long period ending in August, NEJM published 73 articles on original studies of new drugs, encompassing drugs approved by the FDA since 2000 and experimental drugs, according to a review by The Washington Post. Of those articles, 60 were funded by a pharmaceutical company, 50 were co-written by drug company employees and 37 had a lead author, typically an academic, who had previously accepted outside compensation from the sponsoring drug company in the form of consultant pay, grants, or speaker fees.

How is data manipulated?  Drug companies have the power to commission writers, compensate well-credentialed physicians, suppress negative data, and lobby congress.  We all know that money talks, but the consequences in the medical arena are only slightly more alarming than those in the agricultural or industrial. According to this article, studies are 3.6 times more likely to result in findings that reflect positively on a medication if funded by a drug company.

As a physician, it has taken me the better part of a decade to peel away the trauma-encrusted layers of  “truth” that were battered into me over the previous decade of indoctrination.  I understand the collective defensiveness around pharmaceutical interventions.  We’re doing the best we can based on what we were taught… what do you want from us?!  Physicians are not taught about true informed consent because they are not exposed to the true risks nor the true efficacy of treatment, and because they cannot offer meaningful alternatives. Skillful navigation of Pubmed can validate just about any association or claim one seeks to “prove”.  Understanding how to dissect methodology, and reading beyond the abstract, also helps to clarify bias (and even funding sources) inherent in a given paper.  The entire model of medical education is filtered through the lens of medication-driven treatment, and pharmaceutical influence.  There is no effort made to individualize treatments, address modifiable risk factors, or meaningfully prevent future disease.

Only putting out fires.

To truly heal rather than simply reduce or mask symptoms the entirety of that patient must be addressed – diet, stress, exposures, family history, and their life experience spanning from in utero.  We need to reform our understanding of what evidence-based medicine endeavors to be — reform the system; stigmatize researchers, institutions, and physicians who engage with industry — or acknowledge that “data” may not be worth what we think it is.