Abstract
The drug development process of demonstrating an agent is safe, effective and pure has, with rare exception, proven an exemplary path in translational research. The basic science, the clinical trials and the chemistry, manufacturing and control have served public health well. This carefully regulated approach forms the basis of a drug label with data from these studies also used to convey risk and benefit to prescribing physicians through the channels of medical literature and drug promotion by the industry. The latter is also important to public health in that such promotion must be based in the approved indication, be truthful, not be misleading and be substantiated by sufficient evidence. Why then is the emergence of "medical marijuana" any different? While substantial evidence exists for some conditions and some related products have undergone careful investigation through to NDA approval, most claims are not substantiated by research but driven by misguided enthusiasm. While recreational use of marijuana is not at debate here, nor is the right of an individual patient to explore cannabis therapeutically; however, allowing broad unsubstantiated claims around medicinal cannabis to infiltrate the general public is a disservice. To distill the potential medical benefits through the pharmacologic understanding of the endocannabinoid system, cannabis should follow the traditional drug development process or one that improves upon it. Until then, claims should remain as stated hypothesis to accept or reject.