In this interview, Dr. Sexton discusses how she wound up specializing in medical cannabis, what she thinks of the current state of the legal market in Washington, and why it’s important for commercially-produced cannabis to undergo scientific testing.
Read the full interview below:
How did you first get involved in cannabis testing?
I became interested in the potency of cannabis when I was working as a postdoctoral fellow at the University of Washington. I was learning to measure endogenous cannabinoids in human serum and studying the role of this system in neuroinflammation. My research project hypothesized that Cannabis was a potential “supplement” to a deficient endocannabinoid system in patients with Multiple Sclerosis.
During the time of my studies, medical cannabis use was becoming increasingly prominent. By gaining understanding of the pharmacology of plant cannabinoids in humans, I became curious about the quality of the product that was being dispensed, and their health effects. It occurred to me that, as a doctor, I could be more effective to patients by understanding potency and by learning how to work with milligram doses. A start on this would be to measure percent potency in flower or other products and build on that.
At the time, hardly anyone was providing cannabis analytics (two laboratories nationwide), and conventional laboratories would not handle a schedule I drug, and there was no lab offering this service in Washington State. So protocols were non-existent from a business perspective. I took what I had learned in the laboratory about assay validation and Good Laboratory Practice and applied it to plant analytics, which I already also had some experience in (other paper). I wanted to expand my knowledge about the Cannabis human relationship.
Were there established protocols and methods at the time?
There were methods published in the scientific literature, but it was a little difficult to get my hands on reference standards, which still are not certified. I was able to learn from a couple of reputable people and went back to the lab and replicated their method.
When did PhytaLab come into existence, and what led to its inception?
Phytalytics, now PhytaLab, came into existence in 2010. I knew that my postdoc would be over in the fall of 2011 and I was thinking a lot about my career path. Because I really wanted to focus on whole-plant cannabis research, and seeing that it would be practically impossible under the current Federal laws, I decided to embark on a ‘private’ research initiative by collecting plant data in the private sector. Because I am also a practicing doctor and can recommend Cannabis in Washington State, I had the unique opportunity to have a very intimate “window” into both the potency of what people were using and the clinical effects. I set out to do to his and by learning from people like Arno Hazekamp who were already doing it, and through a couple of laboratories where he had consulted. Arno’s doctoral thesis was on the topic of cannabis and analytics.
What has been one of the greatest obstacles that you have faced while growing the business?
I think one of the greatest “obstacles” has been what is known as “citizen science” and in the case with Cannabis, the extension of the concept to include “citizen medicine”. Due to the federal status, crowd-sourced science has virtually replaced clinical research, being “loosely” conducted without the usual controls or theoretical frameworks. I think that the Cannabis community was really skeptical of analytical laboratory work in the beginning, particularly when the result did not come back as they would have hoped! And in this information age, everyone is armed with data and evidence so often it seems like professionals have no platform any more. So labs are still under extreme scrutiny and all of the citizen scientists are out there conducting their own proficiency tests across labs. I think I would prefer if clients came to our lab because they see where our expertise has come from and it speaks to them. The industry has a long way to go to bring black market labs to a level of proficiency of academic scientists. Another major obstacle has been my gender, which is always difficult in science. This would mirror the general gender issues in the cannabis industry. I think my credibility was questioned because of being a woman scientist.
Was there a particular event that served as a catalyst for cannabis testing to come into the public eye?
One particularly memorable event occurred in the spring of 2013, when the WSLCB brought together the handful of labs on the West coast, to discuss the analytical sector of the emerging legal landscape in WA. We formed a core of consultancy, and intimately involved in that process was the publishing of the American Herbal Pharmacopoeia Cannabis Monograph. I had been acting as a technical advisor and editor on the preparation of the monograph. The LCB adopted the Monograph to guide the quality assurance testing of the retail product in WA State. Later I was hired to write a laboratory certification checklist for the LCB and the industry was really waking up to the need of greater professionalism and proficiency. So, the publication and subsequent adoption of the Cannabis Monograph by the WSLCB and this meeting that has come to be called the “summit” were a real turning point. It resulted in the first time that a State stepped up to create standards for testing and quality control of Cannabis.
Not only testing has been affected by alliance with the herbal products as an industry. The American Herbal Products Association also developed a Cannabis Committee, where industry leaders came together from many States to write regulatory guidelines for producing, processing dispensing and testing Cannabis. This has led to a certification process, Patient Focused Certification, that was industry-driven and informed, and has been adopted in Washington DC.
For states looking to create regulated cannabis markets, what would you say the most important considerations are regarding mandated testing?
I would say “don’t overthink it”. It is after all a plant, not a pharmaceutical and not necessarily a dangerous substance, based on toxicology data. I think Cannabis should be clean and people should know the potency with reliable accuracy as well as anything that was applied to it during the growing process. If people want to claim that it is “medicine”, it would probably be best to conform to the standards of other herbal products that we are allowed to make claims about. I think that informed choice is always in the best interest of people in general.
For consumers, what are some of the greatest risks related to a lack of quality assurance testing?
Concentrates, or a food product, “edibles”, that have had flower extracted into butter, or made from a concentrate are the riskiest items in my opinion. It is imperative to know how potent an edible product is, and to be fully informed about the potential short and long-term consequences of high dosing. From a pharmacologic perspective, typically there can be “too much of a good thing”, with opiates serving as a good example. For example, from inhaling a rolled joint of about 15% THC you might inhale about 10 mg. Inhaling a concentrate “dabbing” might provide about 50 mg THC delivered directly to the blood stream. Although tolerance does develop, who knows if it is in the best interest of our endocannabinoid system. Additionally, “results may vary” across individuals particularly with edibles because liver enzyme metabolism will play a role in the potency.
Additionally, anything that has been applied to the plant is likely to be concentrated during an extraction process, such as pesticides, fungal toxins and even the naturally occurring terpenoids. So particularly with concentrates, there needs to be a high level of scrutiny and anything that was put on the plant during the growing process needs to be reported and quantified. Terpenoids are known to be toxic at more than “drop” doses.
Is there anything in Washington’s regulatory framework with regard to testing that you would change?
There are probably a number of things that could be improved upon and we are addressing these items with the State currently. However, without any enforcement, it’s hard to say who in the Industry will comply with the states rules. 1) There has to be standardized sampling. 2) Proficiency testing is an imperative, for every test that is being performed. 3) It would be in the best interests of the Industry for labs to agree upon some processes and their validity, such as microbiological testing. We of course need more research to inform these things, which is very difficult under the current legal frameworks. It is great that now professional organizations are taking an interest, such as the American Oil Chemists Society (AOCS), the Association of Official Analytical Chemists (AOAC). These are preparing to validate methods and provide proficiency testing. This is very much needed for an industry that is coming out of the black market and into the light. There are a lot of what I term “black market practices” in the laboratory sector. It will be in everyone’s best interest for the professional community to shine their lights into the processes.
If cannabis were to be re-scheduled at the federal level, should testing regulations ultimately come from the FDA, or should they be left to individual states or independent organizations?
Once scheduling change happens, it will be a game-changer with regard to professional organizations getting involved, such as the ones I’ve already mentioned. The US Pharmacopoeia would step in, the AOAC would participate, and standards and methods would proceed down the paths that other standards and methods take. This would affect all of quality control. The FDA only gets involved if something is being developed as a “drug”, or for the purpose of marketing it to treat a specific condition. So I think commercial labs could still function under State laws, but large commercial and pharmaceutical grade labs would become involved.
What do you think the future of medical cannabis looks like?
My personal vision is the same as for all botanical medicines: enough for everyone, without excessive government intervention. I hope that Cannabis will continue to be a “Gateway Herb” to other natural medicines and continue to drive a healthcare revolution. I think patients should have whatever variety of Cannabis they like or find effective, and that it can be be grown in their own backyards and processed in their own kitchen, should they choose. Should someone want to make a medical grade product and sell it to others, it should be subjected to the same rigorous standards as other herbal products manufactured under Good Manufacturing Processes (GMP). If someone wants to make a claim about a product (“cures cancer”, or “treats anxiety”) it should go through the same FDA process that other medicines must endure to validate such claims. I also envision pharmaceutical grade products that can be administered IV in the emergency room, such as CBD for traumatic brain injury or stroke. Cannabinoids for all!
Thank you, Michelle, for providing such great insight on a part of the industry that doesn’t get enough exposure! We’re looking forward to hearing more from you about PhytaLab’s continued growth and success in the future.
If you have questions for Dr. Sexton, please feel free to post them in the comments below or to get in touch via the PhytaLab website.