In an article in the Globe and Mail, Anna Reid (President of the Canadian Medical Association) and Rocco Gerace (President of the Federation of Medical Regulatory Authorities of Canada) have argued against the recently released “Marijuana for Medical Purposes Regulations.”  The Regulations are designed to treat marijuana “as much as possible like other narcotics used for medical purposes.” Reid and Gerace emphasize that marijuana is not like other narcotics, or any other prescription drugs available in Canada, because it has never been subjected to clinical research that “provides physicians with critical information for the use of a medication including when to prescribe the drug and in what dosages, and what its benefits, risks and possible side effects are.”  This research is generally required by Health Canada before a drug can be made available; marijuana is an exception in this regard.

The reader comments on this article are (unsurprisingly) varied in their insightfulness, but many people have pointed out that marijuana has been “tested” by many more people than pretty much any prescription drug.  Of course, this does not establish that marijuana is effective for the treatment of pain or other medical conditions, but the commentary does echo some serious questions about the adequacy of pharmaceutical testing.

First, in order to be approved for the treatment of a medical problem, a drug must be tested in randomized controlled trials (RCTs) and shown to be superior to placebo.  Once the drug has been approved, however, physicians can prescribe it for any condition, regardless of whether it has undergone testing for that indication. This phenomenon is known as “off-label prescribing.”  There is no policy or method for tracking outcomes from off-label prescribing, so the safety and effectiveness of the drug for these other conditions remains largely unknown.
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Second, speaking of safety, the vast majority of RCTs require study participants to take the study drug (or placebo) for only a short period, perhaps two months, but when the drug is actually prescribed, patients often use the drug for months or years.  RCTs are therefore not able to tell us what the effects are of long-term use, both in terms of safety (e.g. whether the drug has side effects that occur only with long-term use) and of effectiveness (e.g. whether patients who use the drug become habituated to it over time).  Nor, again, is there any effective method for acquiring this information.

So, should marijuana be tested like other drugs approved by Health Canada?  I think this is the wrong question.  Instead, we should be asking whether the mechanism for approval really tells us what we want to know about a drug’s safety and effectiveness, for the conditions it will be used for.  The proposed use of medical marijuana may not be based on sufficient evidence, but that is no less true for other drugs that are prescribed.