When it is fully legalized, cannabis will be regulated just like any other consumable product. Scientific testing to determine potency and safety will be mandated, as it is in Washington and Colorado. However, producers in these states have frequently complained about inconsistent results when they have submitted samples from the same lot to different labs. This has caused many to question the validity of mandated testing, the individual laboratories, and the science of cannabis testing itself.
In our latest podcast, Shango Los speaks with Dr. Michelle Sexton of Phytalab, a prominent cannabis testing lab in Washington State, about how the Schedule 1 status of cannabis has hindered the necessary scientific research that goes into forming the foundational understanding that is established regarding other plants in the market. This has led to the adoption of different standards by different labs, which–along with many other factors–has contributed to the significant variance in testing results that cannabis producers in regulated markets have witnessed.
“…There’s a difference between certification and proficiency. That’s the bottom line.”
Dr. Sexton is a naturopathic doctor, an editor and advisor on the American Herbal Pharmacopoeia Cannabis Monograph, and was a consultant in the development of Washington State Initiative 502, which formed the legal recreational market in the state. In the interview, she also discusses her stance on cannabis use during pregnancy, a topic which she has written about for Ladybud Magazine.
Listen to the podcast or read the full transcript below!
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Read the Transcript:
Shango: Welcome to the Ganjapreneur.com podcast. My name is Shango Los and I will be your host today. Dr. Michelle Sexton is a naturopathic doctor, herbalist, and formerly a midwife, currently in private practice in San Diego. She began her formal study of phytochemicals with a degree in horticulture and specialized in the phytochemical analysis of botanical medicines. She completed a three-year NIH funded, post-doctoral fellowship at the University of Washington where she conducted a clinical study examining the effects of cannabis in patients with multiple sclerosis. She owns and is chief science officer of Phytalab Cannabis Analytics in Washington State. She also served as editor and advisor on the American Herbal Pharmacopoeia Cannabis Monograph. She has been a consultant to the Washington State Liquor Control Board on the implementation of I-502. She is also a member of the International Cannabinoid Research Society, the International Association for Cannabinoid Medicines and the Society of Cannabis Clinicians. Dr. Sexton is executive medical research director at the Center for the Study of Cannabis and Social Policy. She’s also an avid surfer, rock climber, and loves to play with her grandchildren. Welcome back, Dr. Sexton.
Michelle: Thank you.
Shango: Thanks again for being with us. We enjoyed our print interview with you so much that we wanted to take another opportunity to talk and delve more deeply into cannabis testing in this podcast. Towards the end we will also discuss your recent article on cannabis and pregnancy, but let’s start with cannabis testing first. As the medical and recreational markets evolved in several states, producers are experiencing frustration with their lab testing results. They’ve had the experience of sending what they believe to be similar samples to different labs and they receive significantly different lab results. This is leaving many producers thinking that the science of cannabis testing is questionable. Would you speak to that topic and share what you have been seeing happening and what you find might be the cause for this disconnect?
Michelle: I think everyone has been observing and there’s been reports across states of variability in potency results, particularly on cannabis products whether it’s flower or another derived product. Since this is science, there seems to be a perception that it should be infallible, I think. When you’ve look at where this industry has evolved from, I think it’s pretty self-explanatory that the typical standards that are put in place for an industry happens at a level that’s way upstream from the consumer receiving a result. The Schedule 1 status of cannabis has prevented the normal channels who get involve in this type of proficiency work and standardization from doing so.
Shango: Meaning that the way that the individual states are making their law, they’re more based on ideals than what can actually happen in reality?
Shango: In what ways? Where do you see the disconnect to be then versus when you are involved with Washington State developing their certification and we got a lot of certified labs which leads those of us who are producers to think, “If they’re all certified, they should all give me the same results.” Why isn’t that happening?
Michelle: Because there’s a difference between certification and proficiency. That’s the bottom line. Certification means you’ve met a lot of general standard laboratory practice on paper, how business is conducted in the laboratory everyday is a lot of what the certification checklist was. As far as anyone checking up on the proficiency of the work that is done within the context of that lab, it’s a different topic all together. That proficiency, can’t occur like I said because all of these upstream things haven’t been addressed to start with.
Shango: You’re saying that the certification with the state is more a stop gap to make sure that the bureaucratic nature of the lab is accurate but not so much on the skill set of the scientist doing the work?
Michelle: Maybe in some cases the skill set of the scientist but not necessarily. I think many of the labs who started out with non-scientist have now brought scientist on board. It’s the body of knowledge that we as scientists typically look to that is not there.
Shango: Because the appropriate work hasn’t been done on cannabis yet?
Michelle: Right. For instance, when we published the cannabis monograph, the first part of it, which Washington State adopted, Roy Upton, the executive director, when he publishes a monograph, the section on the chemical analysis of the plan whatever method he publishes has gone through a process called, “Validation,” being validated in a laboratory setting. There’s about eight steps or so involved in validating a methodology. This is done by some professional organizations who do this on a large scale, but because of the schedule on status, they were unwilling to participate in the validation methodology, in doing the validation of the method for the monograph.
Shango: So in a lot of ways, the labs have not been given the tools they need to do their job correctly because on the federal level cannabis is still schedule one, so the needed scientific background to do the testing hasn’t even been completed yet?
Michelle: Correct. If he goes to prior to that, what we use to quantify for instance cannabinoids or any other phytochemical are called, “Reference Standards.” The reference standards that are available for doing this work are still in question as to the purity of them. While we may be told of this is 98% THC, there is a certifying body that would say, “Yes, this is 98% THC,” but they’ve been unwilling to get involved because it’s a schedule one substance.
Shango: This kinda gives credence to the producer’s concerns that the science behind it is in some way faulty, because it may not be the science itself but the base research that needs to take place so that cannabis testing as a whole can be done accurately that hasn’t been done yet. It makes sense that labs are having a difficult time getting consistent results.
Michelle: If you just took the reference standard, say five labs bought their reference standards from five different companies, but if I bought all five of those in random side by side, I might actually see a different quantity even though they should be the same quantity. If I measured X number of milligrams of THC, from each of those five vials from different companies, what I might actually see on my instrument could be really different.
Shango: Other industries that are more evolved than the cannabis industry, are there standards already consistent because they’ve done all that homework and so you wouldn’t have the inconsistency between different companies you bought from– so that’s unique for cannabis right now?
Michelle: Correct. First of all, you have to have a method that’s been validated and typically the way this is done, it’s very rigorous and it’s costly and takes a lot of time, because a method is developed and it gets sent out to 10 or 15 laboratories who all use that exact same method and may make sure that everybody using that method can get the same answer.
They’re also using the same reference set of standards that have been certified. If you were doing that, we should all get the same answer. Everybody’s using different methodologies. None of them have been validated by one of the large bodies who does this work professionally. Those are two upstream problems.
Shango: No wonder everyone is frustrated then, if it sounds like the testing is doomed from the beginning?
Michelle: I don’t think it’s doomed. I think it fits perfectly with all of the citizen science and the citizen medicine around cannabis. This is just the result in the culture of it having been black market. Black market practices have emerged all across this industry whether it’s helping or dosing or telling patients how to use it from a perspective of citizen medicine or if it’s people trying to figure out processes, how to do extractions, on and on, everybody’s had to do this on their own because there hasn’t been a lot of professional industry or research to guide it.
Shango: I know it’s hard to breakout a crystal ball and give me a future answer, but in your experience, you’ve been doing this a long time, how long do you think it might be before that background research takes place to create a standard so that all of the labs can be giving more consistent results, it doesn’t have to wait until cannabis is unscheduled so that that research can get done or is it just the free market forces are doing that homework now so they can bring those standards to market sometime soon?
Michelle: Everybody’s interested. I can tell you everybody’s interested. The United States Pharmacopoeia, they’re very interested. They publish methods. The AOCS, the American Organization of Analytical Chemists, AOAC. The American Oil Chemists Society, they’re all interested and they’re all looking into it and they want to hear about it and they’re asking people to tell them about it and they’re forming groups to talk about it. The fact remains that as long as it stays on schedule one, that many of them have their hands tied or they won’t get involved in doing their professional work on that topic.
Shango: I understand. For some of our non-scientist listeners, would you explain a little bit about what the monograph is and what it means?
Michelle: The term itself means a single topic. How herbal medicines and even now pharmaceutical medicines are well-defined it’s in a document called, “The monograph.” That monograph has one topic. For herbs, we for a long time in the pharmacopoeia, there’s been a general outline that you follow when you run a monograph. With herbs, it started as if you’re going to go collect them in the wild, how do you positively identify them growing in the wild? There’s often plans that can easily be confused and one may be poisonous and the other not. As a field herbalist, you could get that basic information and then you could go on and it describes all of the botany. If it came down to comparing to plants and getting the non-toxic or the toxic one, you could go to more specifics on how the flower looks or leaf, that type of thing. Then it goes on to describe how it’s been used historically, how people have figured out that these plants have medical value and what kinds of things is in the written record that it has been used for. Then in the modern monograph with the chemical revolution, now we’ve gone onto describe, if you want to look at particular active constituents, how do you do that and that’s the analytical portion. Then the monograph also covers things on cultivation, pests, managing pests, soil type, just real basic information about growing, gathering, and using the herb.
Shango: In a lot of ways that sounds like it would be the go-to document for anybody who cares about cannabis. So many people do internet research to find out what they need about cannabis and as we all know with internet research, your mileage may vary, right? It sounds like the monograph would have the best science available today, almost like a mini-encyclopedia on this one flower.
Michelle: Correct. In the writing of the document, Roy, he finds the experts in the world in the field on all those topics, so really it should be the most current up to date information that’s available, all compiled in one document.
Shango: When did the last one come out?
Michelle: We published it originally in 2012 and there was an update. That’s the one with the Washington State with the control board adopted to guide the quality control of the cannabis in adult market. Typically it all comes out in one big book and the second part of that book after the quality control is the therapeutic compendium, because we wanted to push the quality control and out to be used in Washington State, we separated them into two documents so the therapeutic compendium is on its last legs of review and hopefully about the first of the summer, there’s going to be the most up to date review of clinical literature, the use of the whole plants across many conditions.
Shango: If somebody wanted to find out more about this monograph, what would be the appropriate search term?
Michelle: I would just search, “American Herbal Pharmacopoeia: Cannabis.”
Shango: Going back to the ideas of producers and they’re trying to find a lab that’ll give them consistent results, one of the things that we’ve been finding is that producers are shopping around for a lab that tends to give them the results that they want more than necessarily what may be accurate results. What do you see as the downsides of shopping around for a lab that just gives you the results that you’re looking for, for example a high THC potency or something?
Michelle: Karma. That’s the easy answer. I think there may come a time that it may not be too far off where there will be auditors going into these labs. We’ve been needing in Washington State and in conversation with the look of control board about the problems that we’re seeing in the labs and that they’re aware of it. They know it’s a problem. What we’ve done is a starting place and there are many of us working to continue to professionalize and change that, that eventually if you’re using a lab that is using what I call maybe still black market science practices. They may close. I don’t think you’re doing your product a service if you’re just shopping for the answer you need or want to get paid or get your product to market. We really hope that over time, the hype over THC will subside and that the beautiful diversity of the plant, other cannabinoids, the terpenoid profile, you don’t go in a one store and say, “Okay, where is the one with the 13% alcohol?” Your IPA. It’s about all of it, all of the how much sweetness is there and how much bitterness is there or what other flavors you like or the smell you like of it. I think the hype will die down. I think that proficiency will come.
Shango: I can see how here in Washington the environment is evolving from people just relying on THC to now talking about terpene profiles and let the terpenes, the human powers and that themselves, it sounds like as the industry matures, we’ll get past our reliance on THC.
Michelle: I think it’s going to be hard. I have only been in one recreational store in Washington State and not been in a couple of dispensaries. The one recreational store that I went in, everything was on their glass. Somebody told me they were allowed to smell a product in that same store. I don’t know if you asked if you get to, but it was very different from the dispensary experience where you could open a jar and really waft that aroma because we have a survey that’s in process of being published on cannabis use. And smell is the number one way people say they select their cannabis. People are actually doing it also based on potency but smell is the number one thing that people said was the most common factor for choosing one.
Shango: Going back to your wine example, there’s some humor on that because if we are selecting our cannabis based on our reaction to the smells, which in a certain way we can think of as our body is choosing the cannabis medicine that we want, but on the flip side, when you are shopping for wine, you don’t usually get to sample or smell it and so maybe just choose based on label, right?
Michelle: Exactly. I’m guilty.
Shango: So, what advice would you give for producers if we started with this idea that a lot of the background science that the testing is based on hasn’t been done yet, and that there is inconsistency from lab to lab… you know, the frustrations of the producers are they’re trying to do research and development on a product and they’re getting different results which makes it very hard to develop a product. What kind of advice would you give them for finding a lab that will work for them when they don’t have a science background to necessarily interrogate them on their science standards? What advice would you give to a producer to help them until the proper science has been done?
Michelle: There’s the American Herbal Products Association has a document on selecting an analytical laboratory. I think it’s really applicable that you read through and you ask some appropriate questions that are some baseline proficiency work. For instance, I’ve had the experience of asking a laboratory, “How often do you run a standard curve,” and just was greeted with blank stares. They didn’t even know what a standard curve was. Finally somebody said, “I think that maybe one who was run three months ago.” To not know what that is if you’re working in the laboratory setting and to only run it once a year, that’s not adequate. You want a lab who can answer that question like that and they run them on a regular basis, maybe even everyday.
Shango: Even though probably most of the producers don’t have science backgrounds, if they armed themselves with that document, they’d at least have questions to be able to gauge the response. If you get a blank stare that’s probably not a great response, but if the lab gives a full response that sounds accurate, even without a science background, the producer would have a probably a better gut feeling about what the lab’s level of competence is.
Michelle: I think there’s plenty of information out there. Like I said, even just that document to get someone enough information to initiate a conversation on some very important points.
Shango: When preparing samples for a lab, I’ve heard lots of different producers have their strategies. Some like to take the cola to the lab so that they hopefully get the highest potency response. Some say that if you prepare in oil, you should do this and that. In a certain way, trying to game the system, but in the end, that’s not going to win for them because while that might give them a good result to sell their product, if they’re doing research and development in developing a product, they’re skewing their own results. I’ve heard you speak on this before. Can you break down very specifically how you recommend a producer prepare their sample for the lab so that the producer can get the most representative answer possible?
Michelle: This isn’t my knowledge, this is standard for herbal products, whether it’s in Europe or United States or China, there are plenty of sampling plants out there. You have to take an entire lot or I would say a harvest of all one plant variety that was in the same section of the greenhouse or room or field and you put that all together as a batch and it gets mixed and you quarter it several times until you’re down to a smaller size. Then you take a random scoop of it. That is a representative sample. Then you have to also consider what is the size of that batch and what’s the final sample size, how big does that need to be to be representative of that whole starting lot size. This was a real failure in the Washington system that they didn’t implement sampling plans.
Shango: The way that you’re describing it, we wouldn’t have a situation where a producer is looking at a lot of cannabis and I’ll take this bud and this bud and send that on in. What you’re saying is that’s not the way to do it at all. It’s laid all on the table and quartering, quarter it and take a random scoops. If I was a producer, I’m not actually choosing my sample at all. It’s randomness that’s choosing it.
Michelle: Right. Yeah, you have to look at the size for instance for the I-502 package, the state says up to 7 grams, we could ask for more. The monograph actually says 10 grams so the monograph wasn’t actually followed here, but for a 5-pound lot size, 10 grams is barely adequate as a represented sample. For instance, some labs are now gaming the system by typing a smaller sample size, but if you do the math, a 2 gram sample size to represent an entire 5 pound lot would only give you a one in 25,000 chance that you might sample something that’s contaminated with a mold or bacteria for instance. Whereas if you just seem to go up to a 5 gram sample, you significantly increase the chance that you’re going to sample something contaminated.
Shango: So in real terms, even though producers continually want to give a smaller sample because obviously the cannabis is money, really it would be in their best interest to give you a larger sample if they really want to find out what is the true nature of the flower that they’re working with.
Michelle: Yes, I think it’s a matter of integrity because now you’re thinking beyond just getting how much money you can get off of this crop. You’re thinking to public health effects and your end-consumer and you’re thinking about standardization in the botanical industry and aligning with that industry.
Shango: You are involved in Washington when they developed their lab certifications and you’ve seen how they’ve played out for the good and the bad. What suggestions would you offer other states who are moving towards normalization and setting up certifications for their own labs? What did we learn from the implementation here that states that follow Washington can learn from our wins and our losses and do better than we did?
Michelle: Well I think there’s data analysis yet that needs to be done like looking at all of these microbiological test that we’re performing here in Washington State and doing the data analysis — did we have enough positives to recommend that this is a test that always needs to be done, or for instance the microbiological limits. The monograph even states that these are not intended to be pass or fail numbers. They’re general guidelines and we have to take into account certain atmospheric conditions or weather that could precipitate more pattern and mildew and so then we might want to consider adjusting those levels upward, testing for the toxins that fungus make instead of the actual amount of mold on the plant material. I think we need to take a hard look at that some of that microbiological data. For the potency, I think a real disservice that’s being done is everybody reporting results like for THC to two decimal points. I think even if you’re not a scientist, it implies a degree of accuracy to you.
Shango: Which isn’t actually there?
Michelle: No, it’s not there. When we get those sorts of numbers, when we do research-based science, we’ve run at least a triplicate sample and usually in triplicate at least three or four times before you result, and there’s an error bar involved. You show the standard deviation that either side of that mean. The bigger your standard deviation, the greater the variation.
— I’m probably like, people don’t know what I’m talking about because I’m using my hands over here — I think my point is and I said this to the local control board and I think it’s in the checklist that it should be reported in a range, unless people can prove that they really have that degree of accuracy, but there’s nobody out there enforcing that degree of accuracy. Like you said, we have a lot. We did a small survey of some plant here and showed a 4% difference from top from the crown to the bottom of the plant in THC content. We could report it in a range that that should be good enough. If it’s 10 to 12%, we know that this is relatively high potency and it doesn’t have to be 10.63, because that’s really not what you’re getting as the consumer.
Shango: It gives a false sense of accuracy?
Shango: Let’s move on. You recently wrote an article for Ladybud Magazine explaining the relationship between cannabis and pregnancy and it was hugely popular and went viral and a lot of people were talking about it. I want to just hit on that while we’ve got you here today. We’ve already talked about how it’s been a challenge to study cannabis while it’s still a schedule one drug. Would you review for us the state of the science and what you read it to mean around whether or not pregnant mothers should be using cannabis?
Michelle: Because it’s been considered a drug of abuse and because just doing any research, in pregnancy it’s very difficult because now you’re exposing a developing fetus to a drug as well. It’s generally been viewed through the lens of looking at women who are drug abusers. You have to right-off-the-bat think, “Most of the data out there is being viewed through that lens.” Many of these women who were involved in the surveys or the studies may have also been using other prescription drugs. There hasn’t really been enough good studies of just cannabis use in pregnancy. There is some longitudinal data showing birth weight’s fine, head circumference is fine, there’s not poor outcomes. We know it’s not a teratogen, it doesn’t cause birth defects. When you see a beautiful baby at birth and your child develops normally in the first years of life, the conclusion logically is, “I smoked all during pregnancy and my child is just fine.”
I think what’s now coming out in the emerging research is we know more about that developing brain and how the cannabinoid receptor CB1 which is were THC binds is really involved in the migration of neurons on their pathways out to make connections. That was my point is I think it’s awesome that it’s not a teratogen and I think it can be valuable for women suffering from severe hyperemesis or getting very sick with morning sickness because we don’t have good or safe drugs. There’s maybe one drug on the market and it’s not always effective. Again, no drug is the best drug in pregnancies. I think all doctors should have that viewpoint honestly, and I would hope all parents would. Just being really thoughtful about it and being open-minded too. The other is a small amount of literature that says the things that I just said you’ll have a normal birth, you’ll have a normal child, the child would develop normally at early years, and how about those migratory pathways and brain development into adulthood.
Shango: From reading the original article that you wrote, you spoke a bit about how the child may be born not looking like there are any challenges, that some of the surveys suggest that as the child grows up and reaches adolescence that there may possibly be some neurological impacts, but the problem is that there’s no really good studies on that yet. If a pregnant mother was trying to weigh out for herself whether or not to have cannabis, not recreationally because you’ve already said that the best drug is not having a drug when you’re pregnant, so I will follow that. Let’s say that she is having very significant nausea and she doesn’t want to take the pharmaceuticals that would normally be given for that because that is just another drug. How would you suggest that she think through weighing, trying to get through the pregnancy with this extreme nausea versus an unstudied risk of having cannabis?
Michelle: I think there’s a lot of other alternative options. There’s acupuncture, there’s ginger. I was horribly ill with morning sickness, peppermint worked really well for me. I think there’s other options to try before going to a really strong drug like cannabis. Even then, if you go through everything and I think this is one case where I think you should have everything else fail, and then go to cannabis and then go to a CBD dominant variety because cannabidiol or CBD doesn’t bind like THC does to the CB1 receptor and it’s also been shown to be effective for nausea. That would be an alternative and to just use the lowest necessary dose for the shortest time period.
Shango: It sounds like when choosing the particular strain one would take just because it’s sold as a CBD, that probably wouldn’t be enough. For example a Harlequin which is two to one, you’ll still end up having a lot of THC in it, you want something more like an ACDC or something that tests 20 to 1, so the amount of actual THC in it is exceptionally low.
Michelle: That would be my speculation and probably my recommendation without having done a therapeutic trial on anyone. I don’t know. That’s just my best guess.
Shango: Sure, and again, here is something else that we don’t have the real science yet because it’s been schedule one for so long and scientist haven’t not been free to study the medicine.
Michelle: I think too the return of the biodiversity with the cannabidiol rich plants, we have no data on that. All of the studies have been on THC rich. Anything you find on cannabis is typically THC rich varieties. People need to keep that in mind. When we say cannabis now, we’re not necessarily talking about what has been out there and available. It’s changing. It’s evolving.
Shango: In the Ladybud article, you speak a lot about this one fascinating survey that happened with Jamaican Rastafarian women and over the course of the article, you debunked that survey as being reliable for science, but culturally, it’s fascinating. Would you just talk a little bit about this study and about the women and about how they are taking the cannabis? I think it would be exceptionally interesting to the audience.
Michelle: I’ll say I think you should interview the author because I’m not an expert on her work. I’ve reviewed it for the monograph and to write this article, but yeah that was what I … The first paper what I found interesting, and what people overlook or you don’t hear, is that largely the women were not smoking at that time and their place in the culture, that was mostly the men. I’m sure there were women who smoked but the women that she was hanging out with in this anthropologic study were primarily drinking tea. If you go [inaudible 00:35:48] published a paper on conversion of THC acid to THC NT, and there’s not a huge conversion. There is some conversion that it’s nowhere near the amount of conversion that would happen with smoking. Again, we don’t know a ton about THC acid. There are speculation that maybe it doesn’t get to the brain as easily as the neutral form, dealt in on THC without the acid. Maybe it acts more peripherally. Nobody’s looked at whether it crosses the placenta, if you have a baby growing. I think it’s something to keep in mind that largely at that time they were not smoking. They probably weren’t getting huge doses of the neutral cannabinoid THC.
Shango: Thank you for joining us today on the Ganjapreneur podcast, Michelle. Dr. Michelle Sexton is the executive medical research director of the Center for the Study of Cannabis and Social Policy. I am your host, Shango Los of the Vashon Island Marijuana Entrepreneurs Alliance. Thank you for listening to Ganjapreneur.