Source: jamaicaobserver.com
The recent approval of the drug Cannabidiol (CBD) by the US Food and Drug Administration (FDA) is a decision of seismic proportions to the medical cannabis business. The Drug Enforcement Administration (DEA) must now make a determination as to the classification of CBD based on the FDA's finding of medicinal value for this purified drug substance derived from ganja. This is a real cliffhanger. If the decision is made to reschedule CBD from Schedule 1 (no medicinal value) to one that assigns medicinal value, then, as the Americans like to say, “Katie, bar the door!”
It is likely that the schedule of CBD will change. Some are predicting the “pharmaceutical commandeering” of the CBD market in the USA that puts hemp-based nutraceutical manufacturers at a disadvantage.
Implications for the JAMAICAN SYSTEM
One does not have to be a rocket scientist to figure out that this decision by the FDA is likely to change the global medical cannabis industry. Standards for phytosanitary growing, testing and use are likely to become more rigid. The need for evidence from randomised, controlled clinical trials will escalate as the very essence of the medicinal cannabis market changes. There are huge implications for Jamaica's fledgling “herbaceutical and nutraceutical market”.
There are investors who feel that the impending transformation puts Jamaica further behind. There are others who are ensuring that the capacity to cultivate is linked to the infrastructure to test and do clinical trials. This remains a great opportunity for Jamaican cultivators to work closely with universities to attract investment with a from “seed to bedside approach”. Either way, profound changes are coming, and the jury is still out as to whether Jamaica is ready to navigate the regulatory shifts that will be needed.
Good science is critical
Jamaica must become known as a place where good science is respected in the medical cannabis business. Attention must now be paid to plant identification, stabilisation and standardisation of growing and testing methodology for product development. Indeed, the technology is advancing rapidly and may make irrelevant some of the processes and hurdles that now apply. There is a new era of testing techniques that have reduced the old issue of lack of standardisation with the ganja plant.
Testing of both the genetics being grown and the product from a standardised growing method, using these newer, advanced testing methods, allows doctors, pharmacists and users to be sure that the ganja is grown to medicinal standards and can be relied upon to contain the compounds needed for that particular therapy.
Genetic testing is ushering in an era in which product developers can be confident of the nature and consistency of the active ingredients in the plant before using valuable resources to grow plants that may not even contain the active ingredients desired. Genetic testing allows optimised breeding programmes that can produce enhanced versions of cultivars targeted for specific cannabinoids or terpenes, or any of the still undiscovered compounds that exist in Cannabis. Genetic identification and testing programmes also can be used to do rapid generation cycling, so that arriving at stabilised genetics no longer takes 5-10 years, but rather 18-24 months, further ensuring that there is consistency and reproducibility in the plants and chemical profiles for long-term patient care.
Most importantly, the very advanced chemical and genetic testing methods mentioned enable Jamaica to maintain its unique niche in the developing global cannabis economy. No longer will the world be able to take those things uniquely Jamaican and dilute them throughout the world without Jamaica receiving its due. Jamaican staple ganja strains, such as Lamb's bread, Jamaican Pearl, King's Bread, Jamaican Dream, Collie Weed, and Jamaican Lion, grown in Jamaica can be marketed and protected using genetic identification, chemical profiling, and soil isotope testing, equivalent to the concept of “appellations” used in the wine business. Only the ganja grown in Jamaican soil using Jamaican genetics and exported from Jamaica would bear the right to be named as such.
Using this as a starting point, the unique output of the combined Jamaican genetics and cultivation in fertile Jamaican soil, grown reproducibly from stabilised genetics, then can be used to provide a good foundation for any clinical trial or product development enterprise.
The capacity to do great science in this industry will erase our historical disadvantage of producing raw material only. It is the difference between exporting raw material to foreign centres and producing finished products of unchallenged quality with the “Made in Jamaica” brand.
A warning shot
In its public comment related to the approval of CBD the FDA did refer to the persuasive power of good science that convinced the reviewing body of the safety and efficacy of the product to treat seizures from two rare and severe forms of epilepsy for patients two years and over. However, the FDA warned that punitive action will be taken against the illegal marketing of CBD-containing products making unapproved medical claims. How this warning applies to foreign hemp-based manufacturers is not clear. However, we know enough about how the wheels of the international markets turn to propose that it is time for Jamaica to begin to reshuffle its deck.
Ellen Campbell Grizzle, RPh, is associate professor of College of Health Sciences, University of Technology, (UTech) Jamaica, and Reggie Gaudino is chief scientist, Steep Hill, international testing partner for research and development with UTech, Jamaica.
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