The Federal Government's Failure to Support Sound Medical Cannabis Research
Unfortunately, the types of (governmental) funding mechanisms that scientists typically rely to cover the costs of formal research investigations are largely unattainable to medical Cannabis researchers. This is because the federal research regulating agencies that authorize legal access to Cannabis sativa have been historically opposed to therapeutic uses of the plant. Moreover, what little research these federal agencies do allow is currently hampered by unnecessary or inappropriate bureaucratic procedures and reliance on Cannabis products and synthetic pharmaceutical formulations that are not representative of modern, natural, whole Cannabis currently used by millions of patients. This has created a truly unique and an unnecessary paradox in modern medicine; physicians are authorizing treatments to patients and patients are regularly using medications without a scientific basis of knowledge on patient outcomes, forced rather to rely only on externally invalid or anecdotal information.
Other Barriers for Cannabis Researchers
Apart from following internal human subject protection procedures, such as Institutional Review Board approval, a scientist designing a clinical trial on the effects of Cannabis sativa using human subjects must conduct several independent and lengthy procedures that include filing for an Investigational New Drug (IND) with the Food and Drug Administration (FDA), registering the study and obtaining approval from the Drug Enforcement Agency (DEA), and purchasing the Cannabis sativa to be used in the study through the National Institute of Drug Abuse (NIDA). An IND requires a level of specificity that may be difficult to achieve with a whole, natural plant product or even undesirable when one takes into account the variation of natural phenotypes and the range of products used by patients. In the case of new drug development with the intent to commercialize, such oversight may be prudent, but it is unclear why a study on, for example, the effects of smoked Cannabis sativa on driving impairment would also require an IND after receiving approval by a qualified Institutional Review Board.
After filing for and receiving IND approval from the FDA, the scientist must also register the study and receive approval from the Drug Enforcement Agency, an organization tasked with the conflicting interest of “enforcing controlled substances laws and regulations,” which currently prohibit possession or distribution of Cannabis sativa, obvious components of any clinical investigation. The only exception is for Cannabis sativa purchased through NIDA. In other words, all Cannabis sativa used for research purposes must be purchased through NIDA, despite the fact that NIDA’s stated mission is to bring “the power of science to bear on drug abuse and addiction.” No mention is made of research related to therapeutic benefits or the potential for non-addictive recreational use. Sadly, it is not uncommon for researchers to invest several years navigating this system only to receive a rejection from one of the controlling federal entities, typically the DEA, which carries a notorious record of stalling, impeding, or otherwise obstructing sound medical Cannabis research, according to the U.S. Drug Policy Alliance (Drug Policy Alliance, accessed January, 2016). Clearly, relying on federal research funding from agencies opposed to the therapeutic use of whole, natural Cannabis sativa is entirely inadequate!
Ongoing Problems with Federally-Funded Research
As recently described in Science Magazine, another issue with what little research the U.S. government has approved is the limited potency of the Cannabis sativa products available through NIDA. Reliance on this single source completely restricts researchers from conducting clinical trials using products that match the potency levels of products used in vivo, i.e., studies that would enable scientists to assess the therapeutic benefits and negative side effects of the medicinal Cannabis sativa actually used by tens of millions of people in the U.S. For example, in 2015 out of all the 100+ grants funded by the National Institute of Health (the parent agency for NIDA) with the term ‘Marijuana’ or ‘Cannabis’ in the Project title, nearly every study addressed Cannabis use as a problem behavior, and only two studies measured the (analgesic) effects of Cannabis sativa in real time, each using products with potency levels between 3.5% and 7% THC. In contrast, the Cannabis sativa sold in places like Colorado averaged 18.7% THC levels with some strains registering as high as 35% THC (249th National Meeting and Exposition of the American Chemical Society). In addition to dosing directly with the plant product, a variety of concentrates have been developed for vaporizing or ingesting edibles, both arguably healthier options than smoking, with potency levels approaching 100% THC. Clearly, results from studies using Cannabis sativa obtained from federal sources offer little to no insight into the effects actually experienced by Cannabis patients in terms of both therapeutic benefits and negative side effects, if any.
THE MCRF IS DESIGNED TO SOLVE THESE PROBLEMS BY INDIVIDUAL AND PRIVATE SECTOR FUNDING AND USING INNOVATIVE RESEARCH DESIGNS!
Stith, S. S., & Vigil, J. V. Federal barriers to Cannabis research. Science. 2016; 352(6290):1182.