The demand for plant-based alternatives to pharmaceuticals and Western medicine has never been greater. Yet, while support for plant medicine increases, our understanding of its potential medical benefits and risks remains inadequate. As more patients seek alternative solutions for chronic pain, post-traumatic stress disorder, anxiety, and other conditions, there remains a lack of standardization surrounding recommended dosing and no firm evidence-based guidelines for healthcare providers to follow. In place of hard evidence, patients rely on anecdotal feedback from friends, relatives, and those who work in retail pharmacies and clinics.
This lack of information persists for an understandable reason. Plant-based medicine has been shunned for decades in the United States and, as a result, research has been met with resistance. However, persistence on the part of those with an interest in learning more about its properties has paid off: Today there are more researchers interested in conducting clinical trials, more innovators working to identify novel uses for the plant, and more consumers hoping to find symptom relief through plant-based medicine use.
Despite this surge of interest, researchers continue to face numerous regulatory and logistical barriers. Many of these barriers are linked to the plant’s classification as a Schedule I drug under the federal Controlled Substance Act (CSA) of 1970, meaning that it has no accepted medical use and high abuse potential. The classification likely has fostered negative attitudes more than anything else, but as legalization proliferates across the United States (and, indeed, the world), the expanding demand for information is spurring a corresponding demand for research.
Challenges of conducting research
To understand why scientific investigation has been so limited, it is important to consider the many hurdles researchers face when developing and executing plant medicine studies. The plant’s classification as a Schedule I drug requires many conditions be met before a study can commence. For example, the U.S. Food and Drug Administration (FDA) must approve all proposed research. If human subjects are involved, the Schedule I classification requires researchers to submit a new drug application to the FDA. Furthermore, all studies must secure a Schedule I registration through the Drug Enforcement Administration. Finally, product used in nearly all federally funded research studies must be obtained through the National Institute on Drug Abuse (NIDA) Drug Supply Program.
The final requirement arguably creates the most meaningful barriers to scientific advancement in the field. Two of the most important goals of research are indentifying how different chemovars impact different individuals and conditions, and how different cannabinoids interact with each other to generate specific outcomes. When research is restricted to NIDA-provided product, which has been shown to be more genetically similar to hemp and to contain less THC than many commercially available products, scientists are limited in the chemical properties of the plant they can study. In addition, university biologists cannot cultivate plants with specific chemical properties for investigation.
Furthermore, the CSA prohibits researchers from analyzing the chemical properties of existing plant-based goods in the market, thereby making it impossible to verify the health impacts of commercially available products. When considered in concert, these restrictions make it extremely challenging for researchers to evaluate the potential utility and risks of real-world products with a sufficient degree of scientific rigor.
The good news
Despite the many challenges, exciting developments are on the horizon. For example, in 2017 the National Institutes of Health reported a total of $254 million in grant funding to support more than 400 cannabis research projects. In addition, according to the International Association of Cannabinoid Medicines (IACM), 651 cannabis-related studies are underway in the United States, and many new studies are in development. As the trend toward legalization continues, stigma surrounding the plant is decreasing and acceptance of its use is increasing, particularly for those seeking a solution outside traditional pharmaceuticals. Consequently, there has been a spike in desire for additional data as more patients, physicians, and manufacturers seek information about usage, efficacy, and dosing regimens.
In its June 2018 announcement approving Epidiolex, the nation’s first FDA-approved drug derived from cannabis, the FDA cited “controlled clinical trials” as the “most appropriate” way to bring plant-derived treatments to patients. Epidiolex, an oral solution designed for the treatment of seizures associated with two rare and severe forms of epilepsy, was approved following three randomized, double-blind, placebo-controlled clinical trials. Its approval provides an excellent example of the rigorous scientific research needed to propel evidence-based alternative medicine into the mainstream.
The list of needs for plant medicine research remains lengthy and broad in scope, but most interested parties agree primary goals should include evaluating the efficacy of the plant for treating the symptoms of different conditions and examining how dosing can impact patient outcomes. Specifically, physicians and patients are eager to know which chemical compositions create preferred outcomes for specific conditions as well as how different cannabinoid/terpene combinations impact patient outcomes. Scientists are diligently addressing these research aims, with a goal of building the evidence needed to inform prescription and dosing recommendations. To get to the point where we have truly prescribable plant-based medicine, precise measurement tools for conducting research are critically important.
Historically, most researchers have tracked participants’ use and outcomes via self-report, which is susceptible to bias, and have quantified dose size using an “inhale while counting” approach. Unfortunately, the lack of standardized, accurate measurement tools for research has limited the conclusions that can be drawn from the resulting data. However, recently introduced precise, technologically advanced assessment tools have the potential to change the research landscape by increasing the quality of trial data and the conclusions that can be drawn from it.
In June, researchers at Colorado State University in Fort Collins, Colorado, launched a study using the Gofire Health Suite, which employs a metered-dose, IoT-enabled vaporizer that connects to a smartphone app in order to monitor and track intake in real-time. The three-stage trial is designed to evaluate the efficacy of Gofire’s data-gathering technology for alternative medicine research and the efficiency of Gofire Inhaler’s medicine delivery process. Called a “milestone event for [plant-based] medicine” by the study’s lead researcher, Bradley Conner, the project will be completed in Fall 2019 and may usher in a new era of research.
The ultimate goal, as previously mentioned, is to reach the point where we have reliable, scientifically supported plant-based medicines physicians can prescribe with confidence and patients can feel comfortable using. Sound, scientific evidence likely will generate further support for plant medicine among healthcare, consumer, and legislative audiences; increase physician and patient confidence; “normalize” plant-based medicine use for new patients; and finally remove the guesswork and “trial and error” that surrounds plant-based medicine use today.
I like to imagine a future where physicians can confidently prescribe effective plant-based medicines for chronic pain, epilepsy, neuropathy, PTSD, anxiety, and a host of other conditions and where an increasing number of patients can experience clinically significant symptom relief. This future is possible. We will realize it through scientifically rigorous research.
Meghan Morean, Ph.D., holds a doctorate in clinical psychology from Yale University. Currently the director of research and clinical applications for Gofire, Inc., she possesses fifteen years of experience developing and managing research projects. Her list of peer-reviewed publications focuses on plant-based medicine, alcohol and tobacco product use, including e-cigarettes.