Pharmafile Logo

Up in smoke

The side-lining of efficacy in medical cannabis debates

Medical cannabis

Medical cannabis (or medical marijuana as some refer to it) has received a mountain of press coverage in recent years for a variety of reasons ranging from whether it should be legalised to how it should be used (dried, vaporised, or as an oil, etc) to whether it should be allowed to be advertised or promoted to the general public. All fair questions indeed. The most important question, though, is: does it work? But isn’t this the same question that we ask about every pill or injectable that is made available to treat a medical condition though?

Why does the bar seem to be so much higher for medical cannabis? Look, I can regurgitate the meta-analyses, observational studies, studies with ‘n’s of 10 or 20’ and systematic reviews of other authors but you can easily find them and see the data for yourselves. Here’s the truth: sometimes medical cannabis works and sometimes it doesn’t. I’ve also got some news for you: sometimes your anti-depressant works and sometimes it doesn’t. And sometimes your statin, proton pump inhibitor, works and sometimes it doesn’t. Given patient heterogeneity and the complex co-morbidities that one can present with, it’s not surprising that many medical treatments sometimes work and sometimes don’t.

It’s not surprising many treatments sometimes work and sometimes don’t

A lack of randomised and controlled clinical trials? Please. Don’t even get me started. We all appreciate the role that RCTs play in today’s world but given the suffocating inclusion and exclusion criteria required for today’s RCTs as pivotal studies, the patients don’t even mimic what we see in doctors’ offices anyway. Who really has a waiting room full of Caucasian males, aged from 24-49, with a normal BMI, no diabetes, no cardiovascular disease, no smokers and a clean mental health history? It’s the real-world outcomes and clinical results that count. And in the real world medical cannabis sometimes works. Just like any other ‘drug’ or narcotic. This is not to suggest that future RCTs looking at the use of medical cannabis in specific patient sub-populations are not important – simply that RCTs should not guide our entire thought process on the safety and efficacy of any drug or narcotic. And by the way, lest I make it sound as though the entire universe is free of any good studies using medical cannabis, there is some important work out there. However, the deleterious side effects of prolonged medical cannabis use cannot be ignored (respiratory problems, dependency, etc) however and, as such, we should continue to challenge the scientific community and manufacturers to push for research that helps us better understand these factors. No one is advocating for a helter-skelter and scientifically baseless approach to the use of medical cannabis.

Your (or your government’s) position on the use of medical cannabis in your jurisdiction is what it is. The position here in this article is not about whether it should be legalised or not. The position and what I want you to think about, is whether it works as a treatment option in certain patient populations and whether this ought to be our ‘hurdle’. This is the only question that matters from a healthcare perspective. The policy implications are a separate argument. The other (not so) subtle argument is whether the role of RCTs as the underpinning of drug approvals is becoming over-emphasised. Or, conversely, whether we ought to be make exceptions and find ways to include more real-world outcomes data in our regulatory and reimbursement processes and stop relying on RCTs so much.

I find it to be a weak argument to cite the lack of clinical evidence for medical cannabis as a suitable treatment option for certain patients given the massive amount of off-label use of hundreds of molecules that have been supposedly ‘studied extensively’. The very nature of off-label use suggests that there is a lack of evidence and the care with which clinicians use drugs off-label knowing that they haven’t been studied extensively acts as a natural restrictor and gives us the comfort of knowing that it’s not being tossed into the drinking water of every household. In other words, nobody is suggesting that we stand on the street corner handing out baggies of marijuana. Ultimately however, whether it’s abortion or assisted suicide or medical marijuana use, the ‘temperature’ of the discussion as a social issue and the ethics of it all is invariably turned up and healthcare ‘conversation’ or angle tends to get turned down or drowned out. As far as medical cannabis is concerned, shame on us. We need to do a better job of focusing on its efficacy – otherwise all the efforts to date will have gone up in smoke.

Rohit Khanna
is managing director of Catalytic Health, a healthcare communications, advertising and strategy agency. He can be reached at: rohit@catalytichealth.com
5th January 2016
Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links