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Cannabis Column | July 1, 2022

Experts discuss how ECS science will change medicine forever (part II)

This article is Part II of our article The ECS: How ECS Science Will Change Medicine Forever.

We spoke with two experts to learn how cannabis science could impact medicine in the 21st century.

Dr. Jan Roberts, LCSW, is an internationally recognized psychotherapist and educator whose approach merges neurobiology, cognitive processing, EMDR, and mindfulness-based strategies in her clinical practice. Dr. Roberts has a private practice in Manhattan. Additionally, Dr. Roberts is a professor at NYU, the founder of The Cannabinoid Institute, and serves as the faculty advisor to NYU's Cannahealth Student Group and NYU's Student Association for Psychedelic Studies (SAPS). Dr. Roberts serves as a Jointly advisor.

Dr. David Pompei, PharmD, MS, is a licensed pharmacist and co-founder of Fiorello Pharmaceuticals, a New York-based medical cannabis company producing medicines for qualified New Yorkers. Dr. Pompei has published scholarly work on the topical use of cannabinoids, educated patients and physicians on qualifying uses, and led advocacy efforts to qualify patients suffering from rheumatoid and psoriatic arthritis for medical cannabis in Connecticut. Dr. Pompei is a Jointly advisor.

Question for Dr. Roberts: As a mental health clinician, how do you think cannabis science will change mental healthcare?

Dr. Jan Roberts:

The ECS is fascinating as it bridges both the mind and the body. Cannabis, via the ECS, can help people learn to live with a healthy mind and body. I would love to see more openness to cannabis among mental health clinicians. It puzzles me that any discussion about cannabis is automatically viewed under the lens of addiction.

I think with the advent of psychedelics into the mental health foray, clinicians are missing the point that cannabis via the ECS can positively impact neurogenesis, provide new insights, and allow for cognitive restructuring. 

I hope clinicians start talking about how cannabis can be used to promote creativity, neurogenesis, and balance. Obviously, we need to do a better job with education - talking more about the history of cannabis use and incorporating more of the spiritual elements. 

Additionally, I hope future research gives consumers a way to get a real-time understanding of their ECS. That would allow individuals and clinicians to understand how an individual's ECS is impacted by stressors, as well as how an individual’s ECS can be positively or negatively impacted by cannabinoids. 

Question for Dr. Pompei: Given the diverse function of the ECS, it seems likely that cannabis science will impact medicine in the 21st century. What is something you are excited to see?

Dr. David Pompei: 

I do believe that as we begin to better understand the endocannabinoid system and structure-function relationships between the receptors and various analog libraries we'll start to see some pretty exciting stuff. 

Some of these receptors, if activated properly, could reduce the inflammatory burden similar to acetaminophen or ibuprofen, and given that these are two of the most widely used drugs in the world, we're talking about real world impact here. 

Question for both: From your perspective, how has prohibition of cannabis affected research and clinical care?

DP: 

One of the many challenges that the cannabis industry faces is the inability (or at least disincentive) to conduct meaningful clinical research. This problem has long been acknowledged by academicians and researchers who understand the complicated dynamics of trying to perform clinical trials (let alone trials of any kind) on a Schedule 1 Controlled Substance. 

JR: 

As a clinician, I have a strong ethical responsibility to do no harm. I made a concrete decision to focus on cannabis from a wellness and harm reduction approach. So I’m a bit disheartened that major universities are interested in researching the therapeutic effects of psychedelics, but still put cannabis into the shadow as if there’s no therapeutic benefit. The stigma is still very real.

Recently a top tier university wanted to partner with my company, The Cannabinoid Institute, to provide cannabis education for mental health clinicians, but they would only do it if it was part of addiction training. I refused because they were missing the point. Cannabis can positively impact mental health – we just need to educate consumers on how to make that happen. Relegating this information to people focused on treating addiction supports the stigma that cannabis already has. My company refused the offer.

Question for both: Pharmaceutical companies fund more than 80% of trials, so if cannabis science is going to lead to new treatment or diagnostic methods, pharmaceutical companies will need to get behind it. How do you view Big Pharma getting into cannabis research?

JR: 

The ECS is a fascinating and clinically relevant system, and I believe that Pharma is taking notice. But one of my concerns is that Pharma will create medications from cannabinoid isolates or use synthetic cannabinoids. One of my biggest concerns in the cannabis space is companies putting profits over people.

I believe that the best cannabis medicine is the flower grown naturally complete with additional terpenes and a host of other effective cannabinoids. Part of the concern I have is that we’re already moving towards plants that have been engineered for the intoxicating benefits (high THC) rather than the robust healing benefits from multiple sources (diverse cannabinoids). I prefer lower THC levels with additional cannabinoids. And I’ve seen high THC levels cause or exacerbate anxiety issues in many patients.

The entourage effect seems to be much more meaningful for the ECS than isolates. I’m worried that Pharma will change what plants are being produced and we will lose the holistic healing effects that the plant can provide naturally. 

DP: 

I have observed - on social media, in clickbait journalism, even in cannabis advocacy -, a tragic misunderstanding of any role that 'big pharma' has had or will have on the cannabis industry. People just like to hate on pharma; I get it. 

I spent a considerable time working in pharma, and despite maintaining a healthy skepticism towards the industry, never saw anything suggesting some grand conspiracy against cannabis. Yes, there was a report of a now defunct, bad-actor company lobbying against cannabis in their home state, but on balance cannabis science represents a much bigger opportunity for pharma than a competitive threat.  

In fact, the success of cannabis-derived medicines like Sativex and Epidiolex are only a foreshadowing of what we could see in ten years. And this shouldn’t surprise us, as much of the pharmaceutical armamentarium was sourced from natural sources - aspirin from willow, or cancer drugs from the yew tree.

But what turns off pharmaceutical companies to the prospect of getting into the existing retail cannabis space is the inability to develop intellectual property, versus developing a proprietary analog library and testing novel, defensible synthetic cannabinoids. 

Rimonabant, an anti-obesity drug pulled from the market due to adverse psychiatric effects, [Ed. Note: an anti-obesity drug pulled from the market due to adverse psychiatric side effects] tends to be the poster child of failed pharmaceutical drug development in the cannabis space. In many ways, it was a first effort to take what we knew about cannabis pharmacology at the time and improve upon it. It didn't work out, but we shouldn't be throwing the baby out with the bathwater. Most pharmaceutical candidates don't even make it to clinical trials, let alone get approved by the FDA. These days, drug companies are capable of screening literally thousands of molecules to select a few candidates for further evaluation. And we know far more about the ECS now than we did in the rimonabant drug development days. If you were to perform a PubMed search of the peer-reviewed literature space now, you'd see a longitudinal hockey stick of publications.

What you're not going to see is pharma selling flower, pre-rolls, nor will we see them opening dispensaries; it’s not their business models. You may someday see infusions, capsules, and liquids of new molecular entities that target the endocannabinoid system similarly to cannabis. 

It’s very likely we're going to see some kind of proprietary analog (inspired by existing research) that does much of what cannabis currently does for many patients, but in a formulation that is defensively patentable such that is a financially viable 'go' decision for a major pharmaceutical company. 

You can see that as a bad thing, but I don't at all. By then, there will be broad access for natural alternatives and a rich amount of public data about what has worked for others for a specific condition. If pharma wants to get more granular and proprietary and expensive, well, that's their purview and I'm grateful I have a choice. But the future of pharmaceutical cannabinoids will be proprietary synthetics with defensible intellectual property protection.

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