By: Dr. Richard Kaufman, Chief Science Officer, NanoSphere Health Sciences
As legislation evolves, the marijuana industry is poised for exponential growth in the years to come. Within a few decades, we will not even recognize what the industry looked like in its nascence. That said, a still-developing industry comes with its fair share of challenges. One of the major concerns the cannabis sector faces today is inconsistency in testing standards and regulations. Although marijuana is used medically to treat a variety of ailments–with tremendous results–there is a distinct lack of standardization in terms of cannabinoid compositions, methods of delivery, dosages and treatment protocols. As a result, it is difficult to accurately describe to patients how it will work with each individual body’s chemistry to treat specific ailments.
Despite difficulty, this is precisely what many vendors try to do. In dispensaries, customers will frequently see a label that claims: “Bioavailability of up to 97 percent” – a virtually impossible number, but the average consumer may not realize that. THC and CBD compositions are being claimed as cure-alls for a variety of ailments without empirical evidence and clinical proof to support it. There currently isn’t enough education around this burgeoning market, and vendors aren’t called out for making such erroneous and outlandish claims.
Medicinal marijuana refers to using the whole marijuana plant or its basic extracts to treat symptoms of illness and other conditions.However, the FDA has not approved it and public perception doesn’t always match this narrative. To elevate the industry’s reputation and to be considered a valid complementary and alternative medicine, those currently involved in creating medical cannabis products must push for improved testing standards to hold vendors across the board responsible for the goods they provide to the public.
This is where pharmacokinetic testing comes in.
What is pharmacokinetic (PK) testing?
Pharmacokinetics is the science of studying how a substance affects a living organism from the time it is administered, throughout its circulation in the body, to the moment it is eliminated. This discipline involves measuring cannabinoid absorption, distribution, metabolism and excretion. Clinical pharmacokinetics is an application of pharmacokinetic data for developing the safest and most effective use of drugs in patients. The science behind it is highly sophisticated, revealing the characteristics and metabolic interactions of cannabinoids and their effects on the human body.
Pharmacokinetic testing is conducted with very sensitive equipment due to the low nanogram concentrations of cannabinoids detected in a milliliter of blood by skilled technicians. This testing is essential for achieving widespread acceptance of medical cannabis as medicine and developing the best cannabis formulations, correct dosing regimens and most effective delivery system of cannabinoids for treating various conditions.
Each different delivery method and cannabis composition carries with it a unique pharmacokinetic profile, giving product manufacturers and consumers a better understanding of the effects they can expect from a given product over time. Pharmacokinetic testing doesn’t measure the biological and physiological effects from cannabinoids like psychotropic activity and pain relief, but rather how long it takes for the active cannabinoids to enter your system from different methods of administration, where they go in the body, the byproducts formed, as well as how long their effects last.
Why does the marijuana industry need pharmacokinetic testing?
Simply put, requiring pharmacokinetic testing as an industry standard would lead to safer, more effective medical and recreational marijuana products and greater consumer education and safety as a result of the enhanced knowledge it would provide.
Pharmacokinetic results capture a snapshot profile displaying the speed and concentration of cannabinoids and byproducts entering the bloodstream, their distribution in the body, and how they are metabolized by the liver over time. This profile enables scientists to compare the delivery and effects of different cannabis product formulations and dosages. In conjunction with psychodynamic testing of biological actions, physiological effects, interactions and receptor activity of cannabinoids, PK testing is required to design effective cannabinoid medications with the most effective delivery system and optimal dosages for treating a myriad of conditions.
For medicinal purposes, we can’t rely on unknown or inconsistent cannabinoid dosages and bioavailability from inhaling cannabis or the extreme onset delay associated with ingesting cannabinoids. We wouldn’t accept this level of guesswork in our prescribed pharmaceuticals; we shouldn’t accept it in our medical marijuana either. When any drug is administered, the patient should know the dosage taken and how much is delivered into the body to produce therapeutic effects. Pharmacokinetic testing provides a roadmap for medical marijuana product developers and consumers. It compares the different delivery methods, absorption and circulation relative to other drugs and cannabis compositions. Without this testing, consumers lack the sufficient information they need to make an educated decision on which products they should use.
Without conducting pharmacokinetic testing, manufacturers and vendors should not be placing cannabinoid bioavailability percentages on their products. Walk through a dispensary and you’ll see wild statistics that are not based on science. Making claims about “rapid absorption” without pharmacokinetic testing the product can be misleading and weaken consumer trust. The industry must adequately educate consumers on what they should look for when purchasing cannabis for medical use while at the same time pushing for a standardized system of pharmacokinetic testing that would provide added assurance and validity for the medical marijuana space.
Pharmacokinetic testing in conjunction with psychodynamic testing of the biological actions and receptor activity of cannabinoids is required to design effective cannabinoid medications with the best delivery system and optimal dosages for treating different conditions.
There is no doubt that human pharmacokinetic, psychodynamic and receptor testing for cannabis medication is expensive and time-consuming, which may lead to a great deal of apprehension from product manufacturers and vendors investing in this kind of program. However, it’s important to think long-term and lay the foundation for key medical standards that put safety, efficacy and responsibility first. The profits will follow.
By uncovering the biological impacts into the blood and throughout the body, PK testing allows scientists to draw conclusions about a drug’s potency, therapeutic potential and effectiveness. While this certainly won’t fix all of the challenges faced by the industry, it is a valuable tool that will provide accurate, essential information for cannabis manufacturers and consumers. This testing is imperative if industry professionals wish for marijuana to be considered a legitimate complement and alternative to pharmaceuticals. In addition to benefiting consumers, this testing will give doctors the crucial information they need to make educated decisions when prescribing medical cannabis to patients.
Performing any pharmacokinetic testing is extremely rare in the medical cannabis industry, with NanoSphere Health Sciences among the few conducting such tests for its product line, Evolve Formulas. As a scientific method, requiring PK testing will add a new level of legitimacy to the marijuana industry, and we must raise our standards to make it a prerequisite for all products and new forms of cannabis delivery that are placed on a dispensary shelf and sold for medical and recreational use. Cost of science cannot be an excuse for long; the industry is going to continue growing at a rapid pace, and it is our responsibility to make sure the science grows just as fast as the profits.