MAY 31, 2018
BRINGING NEW CLINICAL STANDARDS TO CANNABIS PRODUCTS
By Noel Palmer, Ph.D., Chief Scientist, Evolab & CBx Sciences
We talk a lot about analytical testing, because it’s really important for us to understand the terpenes, cannabinoids and everything else in our products. But today, we want to talk about clinical testing - which isn’t really a thing in the cannabis industry. Why not?
The strange situation in the United State whereby many states have legalized either Medical or Recreational cannabis (or both) – while the Federal Government still considers cannabis a Schedule 1 substance – has created a challenging environment for companies involved with cannabis product formulation and R/D.
The typical route for producing a medicine in the United States requires a person or company to go through the FDA process – which is very long and expensive. The basic steps in the FDA process require that a drug go through basic discovery and development (e.g. petri dish testing), preclinical work (animal testing), clinical testing (people testing), and FDA review/post market monitoring. Before the FDA approves a drug, it has to show clear efficacy with well understood side effects. In most cases, this requires that blood samples are used to prove that the drug is being delivered systemically and the drug’s residence time in the body is understood (pharmacokinetics and pharmacodynamics).
There’s another step in this FDA process that most people are not aware exists. In order to conduct any human studies, a research protocol on any given drug has to be approved by an IRB (Institutional Review Board) – which is a group of qualified professionals that will ensure the patients in the study will not be subject to ‘unreasonable harm’ (physical and emotional).
As a Federal agency, the FDA largely won’t acknowledge research attempts involving cannabis. Most of us understand that cannabis and cannabis products don’t need to go through a dedicated FDA and IRB approved process to know that they work. While we might not exactly know the pharmacokinetics and pharmacodynamics of these products and formulations – we can make observations that therapeutic benefits are being discovered.
At Evolab and CBx Sciences, we strive to develop products to as close as possible to a pharmaceutical standard within the legal framework we are allowed to work with. Without access to traditional clinical trials, we’ve found other pathways to developing clinically-informed products.
Over the past couple of years, I’ve worked closely with the team at Realm of Caring as they’ve spearheaded the creation of the largest Observational Research Registry in the cannabis industry and launched IRB approved research initiatives. As a member of Realm’s Scientific Advisory Board since 2015, I’ve been proud to support their efforts which provide invaluable insights about how cannabinoid therapeutics can benefit patients.
To further refine some of our new product concepts, we forged a relationship with a well respected sports physician, Dr. Ben Cowin DC, MS, ATC, CAFS. Dr. Cowin has more than 20 years hands-on experience in sports medicine working with professional athletes competing at the highest levels. His experience includes a multitude of arenas such as Major League Baseball, National Football League, Ultimate Fighting Championships, multiple Olympic teams and many others, so he brings a uniquely-informed perspective on the role of the endocannabinoid system in clinical pain management and performance optimization.
By working with Dr Ben (and Realm of Caring and other groups) – we have found ways to thoughtfully develop products based on clinical experience, without pre-clinical and/or clinical trials that the FDA won’t support. While we look forward to the day that the FDA and Federal government as a whole allow and embrace research into the benefits of cannabis, we’ll continue to find innovative ways to ensure that our products are developed to the highest clinical standards possible.
Learn more about the many research initiatives at Realm of Caring here.