EVIDENT, BUT NOT EVIDENCE?
In July, Colorado’s Board of Health voted 6-2 against adding post-traumatic stress to that state’s list of qualifying conditions for medicinal cannabis. They cited a lack of scientific evidence that cannabis is efficacious and safe for treating this condition.
Similar reasoning led Maine’s health review panel to reject adding to our own qualifying conditions list both Tourettes syndrome in 2013 and OCD in 2014. “(T)he evidence does not sufficiently demonstrate that medical marijuana would be beneficial or effective” for OCD, the latter ruling stated.
A patient who experiences symptom relief within minutes of trying cannabis may rightly be angry and frustrated when told there is not enough “evidence” to justify certifying them as patients. What do you mean, not enough evidence? Look at me – pharmaceuticals haven’t been able to help my condition for years, and this plant works! I am the evidence!
WHAT DOES EVIDENCE MEAN?
Contemporary Western medicine values the randomized controlled trial and discounts the anecdotal; it favors the isolated synthetic molecule over the natural whole plant.
In this paradigm, “medicine” means synthetic, single-compound and standardized dose. The FDA requires that evidence for the efficacy of a medicine must be exhaustively demonstrated in a variety of manners – from lab trials in petri dishes, through animal tests, to small and then large randomized controlled trials in humans. (For an overview of the full process, which can take a decade or more, click here.)
Adding further incentive to the pursuit of single-compound synthetics, these medicines are patentable, and therefore profitable, in a way that plants are not.
The last 25 years or so have seen an emphasis on “evidence-based medicine” (EBM) as a framework for physicians, researchers and health officials to make decisions on best treatments. EBM was defined in the mid-1990s as “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.”
The scientific definition of “acceptable evidence” is both comprehensive from a traditional medical point of view, and exclusionary from a patient-experience point of view. A quick Google image search for “EBM pyramid” returns a number of color-blocked shapes like this one from Harvard, outlining the hierarchy of quality when it comes to scientific evidence.
As you will see, the lowest tier in these pyramids – the very ground floor for acceptable “evidence” – is some variation on “expert opinion.” Herein lies the rub: Individual, anecdotal patient experiences, even in the tens of thousands, simply don’t count in this framework.
More to the point, whole-plant cannabis, with its dozens of active compounds working in synergy, does not and never will fit into the EBM paradigm upon which the FDA’s drug approval process is based. Problem one: too many compounds, making it difficult to isolate which one is responsible for a given effect. (Problem two: the placebo group catches on really quickly.)
WHERE DO WE GO FROM HERE?
As with any trend, the medical pendulum appears to be swinging back from an overreliance on EBM’s hierarchical research qualifications, to an approach that is more inclusive of patient values, experiences, and expectations, combined with the practitioner’s clinical observations.
Millions of U.S. citizens have safely consumed whole-plant cannabis and found that it relieves their symptoms or conditions, although not under the auspices of a randomized controlled trial.
But when a presidential candidate, or a physician, or a public health official says that s/he supports “medical marijuana if it goes through the FDA process,” it is signaling that they do not support patients’ right to use a whole-plant therapy, or to grow their own medicine instead of obtaining one isolated synthetic piece of it in pill form from a pharmacy.
And as long as the conversation about therapeutic cannabis is so heavily weighted toward a “medical” model into which the whole plant can never fit, and the physicians, officials and politicians making the decisions can shield themselves with the “not enough scientific evidence of efficacy” defense; until these things change, patients who could reap the benefits of whole-plant cannabis will continue to be shamed, in pain and criminalized.