Taking the Pulse of the Industry Today: Two Prominent Researchers Explain

As more developments in the industry increase – from the passage of the 2018 Farm Bill legalizing hemp to hearings in Congress about fixing banking issues and enabling the government to provide small business loans - it’s time to take the pulse of the industry from some of the movers and shakers in the science community.

Here, two of the more prominent researchers in the cannabis industry – Dorothy “Dot” Colagiovanni, PhD, vice president of product development for Next Frontier BioSciences; and Cindy Orser, PhD, chief science officer for Digipath Labs - talk about how they see the industry today, what they expect going forward, and why they think the cannabis plant is finally beginning to emerge into the spotlight as one of the most intriguing, and beneficial, plants known to man.

With the proliferation of cannabidiol (CBD) and more hemp-related products flooding the market, why is scientific research into the cannabis plant more important now than it was a few years ago?

Dot Colagiovanni: There has been scant U.S. research into the components of the hemp plant due to federal illegality and DEA scheduling. Universities were limited in the work they could do to understand the medical benefits of CBD and other components of the plant. With the passage of the Farm Bill in December of 2018, the U.S. is opening up the possibility for true scientific research. The explosion of interest in CBD is due to a number of factors: the now legal status vs THC; lack of a “high” (which scares some folks); the positive clinical study data with Epidiolex for epilepsy; and findings of CBD benefits with other conditions such as inflammation, anxiety, and cancer. Systematically characterizing the benefits of CBD and other hemp components will add legitimacy to the data we have been gathering over the past several decades. 

Cindy Orser: As the number of global consumers of CBD increases, the justification for understanding exactly what CBD does and does not do physiologically is ever the more important since we have a very large scale, uncontrolled, unregulated multi-endpoint human and pet clinical trial underway with no metric of “dosing” or consideration of adverse long-term secondary side-effects from chronic use. I believe the issue has remained largely the same, which is the lack of transparency for the cannabis consumer; and now, there is just more bad product sitting on the shelves. Not only is more research called for into the cannabis plant, but we need heightened education to relay findings back to the cannabis consumer. CBD is the same chemical whether it is from industrial hemp, drug-type CBD or drug-type THC cultivars of cannabis.  

Hemp is cannabis and yet enjoys a much easier point of entry to grow, extract, market and sell.  Why is that? Is it an easier, safer on-ramp for the naysayers to merge into the industry and conduct profit sharing? Actually, a good percentage of so-called CBD on the open market is not extracted from industrial hemp but from drug-type CBD cannabis cultivars. At this moment in the cannabis/hemp industry, the overwhelming issue in the industry resides at the interface of the purveyor of cannabis-based products and the cannabis consumer, where there is a continuing lack of accountability, which is a nice way to say that capitalism is alive and well.

Have we reached a stage in the development of the industry where lab work and scientific discovery is critical to the evolution of the industry? Explain.

Colagiovanni: Yes. In order for cannabis/hemp to be viewed as legitimate options for healing by the medical establishment (the American Medical Association, cough, cough) we need experienced scientists conducting research. The use of standard laboratory methods allows scientists to compare data across industries to know that the work being done is valid and appropriate. We can start with the fact that there are no consistent national procedures for how analysis of cannabis is conducted for potency. If we are going to be recommending cannabis as medicine, we should be providing patients the most consistent, reliable, cleanest and safest products possible. Developing standard operating procedures (SOPs) for growing, extracting, and production is the evolution of cannabis research.

Next we need to use the scientific method to validate plant and product efficacy. The concept of evidence-based medicine looks at the best available clinical data to make decisions for individual patients. In many cases these data are lacking. But there is much anecdotal data. We can also look at meta-analyses of studies and other literature available to make educated decisions. With available existing data and, because of the global accessibility of cannabis, taking information that patients have collected while tinkering with optimal plant ratios and strains for the ideal components for particular condition, we are trying to test hypotheses of the disease states that can be treated well with plant-based medicines.

Taking the knowledge these early pioneers have gathered with more consistent products (we like to say Cannabis 2.0) can help us to determine the disease states where tetrahydrocannabinol (THC), CBD and whole plant extracts can provide the most benefits to patients. It’s the concept of the three-legged stool: Clinical information with patient feedback with the available body of literature for discovering the best treatments.

Orser: Yes, I would agree with the statement. The answer to this question is an extension of my answer to question #1 above, which is that we have this massive uncontrolled self-administered human clinical trial underway across the globe. Defined studies are urgently needed to understand so many aspects of medicating with cannabis. For example, what are the impacts of vaping high doses of pure THC?; what is the impact of residual heavy metals and pesticides in vape liquid not to mention all of the diluents being used that are not required to be reported?; what are the benefits of THC micro-dosing?; what are the contributing effects from individual terpenes in combination with individual cannabinoids?; how do the lesser cannabinoids affect efficacy of major cannabinoids? The industry is poised for class-action lawsuits and no one is prepared because only anecdotal feedback exists, and very, very little clinical trial data is available other than for GW Pharmaceuticals products.

There are still many “secrets” of this amazing plant that are undiscovered. What intrigues you most as you do your research?

Colagiovanni: I want to know the optimal combination of cannabinoids plus terpenes plus other (?) to optimize health and wellness.

Orser: I am constantly torn between being in awe of the simplicity of having the cannabis plant in your medicine cabinet for an untold number of common ailments, to the unknown complexities and overlapping nature of the hundreds of bioactive compounds made by this plant. My interests lie in the molecular nature of how Mother Nature has settled on the co-evolution of both the functional structure of chemical compounds, but also the corresponding receptors for actuation of these chemicals, whether man-made or plant-sourced. Truly fascinating to contemplate.

We are setting new standards and digging deeper into the science of the cannabis plant in terms of botanical research than we have done with any other cash crops. What is driving these efforts? What benefit will it provide for other similar agriculture studies? Has cannabis research effectively “stepped up” the work of agriculture research in general?

Colagiovanni: Money. This may prove to be the biggest cash crop of all time.

Orser: I think that the depth of chemical complexity and genetic heterogeneity in the cannabis plant has sparked focused research for the purpose of securing proprietary cultivars for the production of specific cannabinoids by the equivalent of new Big Agriculture, but now for cannabis, which is clearly driven by the goal of making money. Perhaps cannabis consumers and some involved in the cannabis industry itself are not aware of the current and past monumental successes that have all benefited from traditional Big Agriculture for other commodities, such as wheat, rice, corn, and other high cash crops, such as strawberries, almonds, grapes and citrus.

I really do not think that cannabis is showing Big Agriculture the way. I rather believe that cannabis breeders and researchers are now adopting the strategies that have been in use for decades for other crops in marker-assisted breeding, pathogen resistance, etc., and the difference is that there are now new molecular tools to speed up the process. But the end goals remain the same, as big money has entered cannabis with big public relations machines, and pedestrians are paying attention. My question is: Who will grow our food? Looks like we are all set for abundance of cannabis.

At the end of the day, after all is said and done, what exactly is cannabis as you understand it?

Colagiovanni:The most stigmatized plant in the history of earth that has many secrets yet to reveal.

Orser: For me, cannabis as a word is now associated with an industry, a vibrant industry that holds great promise for the well-being of so many humans that had previously been legally separated from this amazing plant that humans have evolved with. Cannabis is also associated with the promise and allure of great financial rewards; however, still not without risks and extreme barriers, such as lack of U.S. federal recognition and therefore lack of banking and normal business deductions, which is no small matter.

The other word of the day of interest to consider at the same time is hemp. Those in political power have latched onto the word hemp and have redefined it in the 2018 Farm Bill as cannabis containing less than 0.3% THC at dry weight, nothing to do with fiber and revitalizing the entire use of hemp as fiber. Hemp has become the safe lane to eventually merge into the burgeoning cannabis industry for its CBD content. What is happening with all that unused fiber?

Hopefully we can all come together, adopt meaningful nomenclature, and advance the field of cannabis in a productive manner.

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