Burden of Proof

Evidence-Based Medicine (EBM) has become the default philosophy to judge therapeutic efficacy and safety. It has never been the complete answer for integrative medicine and CAM therapies. Given the recent slate of public warnings regarding FDA-approved medicines, is the glow wearing off EBM?

Vioxx. Viagra. Strattera. Adderall. Concerta. Serevent. HRT. SSRI’s. What do they have in common? All of these highly-touted pharmaceutical remedies have recently come under fire for potentially severe side-effects not publicized upon initial FDA approval. As Dr. John Ionnadis notes in the July 13 issue of JAMA (v294: 218-228, 2005): “Contradicted and potentially exaggerated findings are not uncommon in the most visible and most influential original clinical research.” What is amazing is not the conclusion noted here, but the seeming lack of surprise and outrage.

New pharmaceuticals are promoted directly to consumers with this message: “It’s safe, it works, we tested it, so trust us.” That the benefits outweigh the risks is almost assumed, for all takers. Yet when a natural health product is promoted, the discussion, especially in ‘serious’ journals, inevitably goes something like this: “Seems promising, but trials too preliminary, too small, watch for inevitable side-effects.” Even though some botanical remedies are more thoroughly researched, components more highly analyzed, and have existed for a far longer time than pharmaceutical company medicinals, there remains a different burden of proof.

There is another assumption that EBM is the standard against which CAM therapies should be measured. Tonelli and Callahan, though, claim in a provocative editorial in Academic Medicine (v76: 1213 – 1220, 2001) that “alternative medicine cannot be evidence-based.” They continue, “The methods for obtaining knowledge in a healing art must be coherent with that art’s underlying understanding and theory of illness. Thus, the method of EBM and the knowledge gained from population-based studies may not be the best way to assess certain CAM practices, which view illness and healing within the context of a particular individual only.” Key integrative medicine principles, such as individuality and holism, may not be completely reconcilable with those of EBM.

In a great editorial titled Tainted Evidence (correspondence from InnoVision Communications), Dr. Bill Benda, Editorial Board Member for Integrative Medicine: A Clinician’s Journal, writes, “The public’s trust in the industry has fallen precipitously in the past few years; not only because of the recent Vioxx-type debacles, but because the patient has begun to question all aspects of the healthcare system, including us, the practitioners. Our credibility is on the line, and if we make a promise, we had better be able to back it up with more than just a hyphenated adjective. So before we elevate the term ‘evidence-based’ to biblical stature, let us remember that evidence is only as valid as the integrity of those who create it.”

Erosion of public trust is one of the main reasons families become frustrated and exit the conventional medicine arena. It needs to be possible for practitioners to advise families honestly about the risks and benefits of new therapies, regardless of their origin. We need to re-establish trust and widen the dialogue to re-engage those who have lost faith in us.