We have been inundated with rhetoric regarding the commercialization of Cannabis sativa and its many hybridized variants for both recreational and compassionate medicinal use. Four western states have already legalized it for recreational and medicinal use with at least 20 more states vying to get a referendum on the ballot for the 2016 elections. There is much money to be made on several fronts, both legal and commercial.
The flower buds of cannabis produce the euphoric agent tetrahydrocannabinol (THC) along with a host of other yet-to-be-characterized cannabinoids including cannabidiol (CBD), the medicinally active compound that is reputed to control/reduce nausea, pain, and seizures either in patients undergoing cancer chemotherapy or in people with epilepsy. CBD has also been reported to benefit Parkinsonism and Alzheimer’s dementia, among other diseases. C&EN published “Cannabis Safety” in one issue (April 20, page 27) and, in another issue, reported in a letter that the American Chemical Society has made official the formation of the Cannabis Chemistry Committee (May 4, page 2).
The Food & Drug Administration, National Institutes of Health, and Federal Trade Commission must team up to sort out the legal, commercial, and medicinal ramifications of this complex enterprise. I believe that the generics industry and FDA could initiate the formulation of extracts of the raw material cannabis collected from legally licensed growers, separate the THC and CBD active ingredients, and formulate CBD into either an oral, transdermal delivery system and/or a pressurized metered-dose inhaler; 3M has extensive experience in making these formulations for other clients. The mega generic pharma firms, including Teva Pharmaceutical Industries and Mylan, expend billions of dollars trying to buy each other up. They could be leaders in this effort, working with FDA for marketing rights.
The pharmacokinetics/bioavailability of CBD in patients will require the validation of LC/MS/MS methodology. NIH can evaluate the clinical safety and efficacy of these formulations in small, controlled patient studies to validate their approval. All this will take a few years to materialize, but it is time to start doing something and stop all the talk about it.
J. Arthur de Silva
North Port, Fla