Health and Wellness

Marijuana medical research a Catch-22

Voters in California, Massachusetts, Maine and Nevada approved the legalization of recreational marijuana this past November. In Florida, Arkansas and North Dakota, voters said yes to medicinal marijuana. In Montana, voters rolled back restrictions on using medical marijuana. Twenty-eight states and the District of Columbia now allow their residents to possess marijuana for recreational purposes or to use at least a small amount of medicinal cannabis products, in accordance with state laws.However, the federal government reaffirmed marijuanaís ìSchedule Iî status in August, leaving marijuana and cannabis products in the same federal legal class as LSD, heroin and ecstasy.According to the U.S. Drug Enforcement Agency, the Schedule I status has been retained largely because research related to the medical benefits of marijuana is limited.Chuck Rosenberg, acting administrator of the DEA, said in an August letter to governors requesting the re-scheduling of marijuana that the decision on where to place a drug in the Controlled Substance Act schedules is not based on how dangerous a drug is, but rather its potential for abuse versus its scientifically proven medical benefits.The current state laws should be a good model for the federal regulations, proponents say. ìThe legalized industry works,î said Mark Malone, executive director of the Cannabis Business Alliance based in Colorado.îThe people who are not meant to consume these products don’t get it under proper regulations.îFor cannabis products to be moved from Schedule I status to another less federally restricted controlled substance status requires additional professional peer-reviewed research showing cannabis as a safe and effective medicine. However, it is difficult for research groups to study substances already on Schedule I. This creates a ìCatch-22î situation for medical marijuana proponents.For the last 50 years, the National Institute on Drug Abuse and the DEA only allowed one grower to produce marijuana that could legally be used in federally funded scientific research in the U.S. ìUnder the historical system, there was no clear legal pathway for commercial enterprises to produce marijuana for product development,î said Michael Lewis of the DEA’s Office of Diversion Control. Under the new policy issued at the same time as the letter reaffirming the drug’s current scheduling, there will be a method for growers to be federally licensed to grow for research and product development by private companies and groups.Marijuana has been on Schedule I since the Controlled Substance Act passed in 1970. Efforts to move it to less-regulated schedules started almost immediately, but were denied in Senate committees in 1974. Organizations like the National Organization for the Reform of Marijuana Laws, commonly referred to as NORML, have continued to lobby and litigate to have the plant downgraded.Colorado’s NORML group thinks that the recent ballot wins for cannabis at the state level will continue to put pressure on the federal government to re-schedule the drug or make scientific study easier. ìI think clearly it was a victory for marijuana,î said Rachel Gillette, board member for Colorado NORML. ìIt’s clear that people are supporting regulated marijuana in the states.îIf political pressure is not enough to force a re-scheduling, the scientific and mainstream medical industries will have to prove to the FDA that cannabis is an effective medicine for specific illnesses. Children’s Hospital Colorado is using state funding to study marijuana in epilepsy, neuro-oncology and inflammatory bowel disease. The University of Colorado is studying the impact of CBD oil on tremors in Parkinson’s Disease patients.A three-year long Children’s Hospital study that started in 2015 is looking at cannabis for otherwise poorly controlled epilepsy. It is an observational study, following kids who are already receiving cannabis products from their parents. It’s also strictly ìbring your own potî because the hospital is not able to provide the cannabis products under current law and policy.While the DEA says it supports medical research into marijuana’s efficacy as a medicine, there are strict guidelines researchers have to follow to make sure the drug is secure. Federal law enforcement must review study guidelines and make sure the research facility has adequate safes, security equipment and other procedures in place to make sure no marijuana products can be ìdivertedî to illegal use, according to the August 2016 DEA guidelines.When the researchers are providing the marijuana or derivatives, unlike observational studies at Children’s Hospital where the patients already possess the cannabis, the marijuana must be sourced from the federally licensed grows. The strains and varieties of marijuana grown at the University of Mississippi lab licensed by the DEA may not have the CBD and THC ratios that the researchers and patients are looking for.Future federally legal grows may also not have the experience of groups like Black Forest’s Stanley Brothers, the company that developed the high-CBD strain, Charlotte’s Web. Applications under the new process could be denied if ìthe applicant has engaged in previous illegal activity involving controlled substances, regardless of whether such activity is permissible under state law,î Lewis said.The new White House administration and Congress can also direct a change in marijuana scheduling without the FDA’s approval. However, they also can tighten restrictions on research.ìIt’s tough ñ the whole industry is in a wait and see,î Malone said.

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