Over the years the one refrain we hear from the U.S. federal government — and increasingly the medical establishment — is medical cannabis can’t be approved because there is no research, no evidence. It has been a conundrum because the U.S. government totally controls cannabis research in this country and has been miserly in terms of allowing either cultivation or research licenses. If we are ever to see the wide-scale acceptance of the medicinal value of the natural cannabis plant there must be more research data.
That’s why I really sat up and took notice when Prad Sekar took the stage at the recent CannaTech Panama meeting. Sekar is the CEO of CB2 Insights, a Canadian based cannabis analytics company. His talk was entitled “The Need for Clinical Real World Evidence in the Cannabis Space” and it contained some bombshell news.
On December 6, 2018, the U.S. Food and Drug Administration (FDA) issued a press release announcing “a new strategic framework to advance the use of real-world evidence to support development of drugs and biologics.” The implication to anyone involved in medical cannabis work should be obvious.
It can safely be said that FDA has not taken this step to help the embryonic medical cannabis industry but it can just as safely be extrapolated that this shift of policy can benefit the medical cannabis movement immensely. Real-world data (RWD), according to the FDA “may be derived from “a diverse array of sources, such as electronic health records (EHR), medical claims, product and disease registries, laboratory test results and even cutting-edge technology paired with consumer mobile devices.”
Sekar’s company has already developed software that can track real-world use of cannabis. His company’s mission is “to mainstream medical cannabis into traditional healthcare…by gathering data and creating objective real-world evidence through our proprietary software and clinical service brands.” CB2 Insights has already collected data from more than 300,000 patient interactions in both Canada and the legal medical cannabis states in the U.S.
For anyone seriously involved in medical cannabis it is time to start thinking about how to put this new avenue of opportunity into play. The federal government will continue to proclaim there is no evidence but it has also opened a new gate through which researchers and activists must pass and start taking advantage…before it closes. ❖
Mary’s Prime Time is prepared by Alice O’Leary Randall.
