Exploring the DEA’s Position on Medical Marijuana
Interview with the DEA and Barth Wilsey, MD
The United States Drug Enforcement Administration (DEA) recently denied 2 petitions requesting reclassification of marijuana, which is currently listed as a Schedule 1 Controlled Substance, into a less restrictive category that would make it more readily available to researchers and patients alike.1-4
This decision comes at a time when a growing number of states have legalized marijuana for a variety of specified medicinal purposes. In addition, a recent meta-analysis concluded "moderate-quality" evidence to support the use of cannabinoids for the treatment of chronic pain and spasticity.5 There was also "low-quality" evidence suggesting that cannabinoids were also associated with improvements in nausea and vomiting due to chemotherapy, weight gain in HIV infection, sleep disorders, and Tourette syndrome.
Understanding the DEA’s Rationale
Practical Pain Management spoke with DEA spokesperson Barbara Carreno to find out what this decision means moving forward for pain patients and for their physicians and other caregivers, as well as for the research community.
Ms. Carreno explained that the DEA’s decision not to reclassify marijuana at this time was made in compliance with the Controlled Substances Act (CSA). In order for this to occur, the Food and Drug Administration (FDA) prepared an “eight-factor analysis” serving as the basis for the scheduling recommendation to the Department of Health and Human Services and the DEA.
In the FDA’s language, such an analysis considers the following areas:
- The drug’s actual or relative potential for abuse
- Scientific evidence of its pharmacological effect, if known;
- The state of current scientific knowledge regarding the drug
- Its history or current pattern of abuse
- The scope, duration, and significance of abuse
- What, if any, risk there is to the public health
- Its psychic or physiological dependence liability
- Whether the substance is an immediate precursor of a substance already controlled under the CSA
As in every FDA assessment, the scientific effectiveness of a medication is reviewed to determine if it should be an accepted treatment under a rigorous FDA approval process.
Therefore, Ms. Carreno said the decision to retain marijuana as a Schedule 1 Controlled Substance, where it is grouped along with other, more dangerous drugs such as heroin, LSD, and ecstasy, is based on the lack of FDA approval for use, the high risk that marijuana can be abused, and concern about its ability to be used safely under medical supervision. The latter consideration is in large part due to the lack of consistency in different strains of marijuana and different concentrations studied across the current literature.
While this decision may be cause for concern for people who rely on marijuana to prevent or treat a host of medical problems, Ms. Carreno said that the DEA will not interfere with state laws that make marijuana available for people who meet the state’s designated criteria for use. So in practical terms, this means that the DEA’s decision should not impact pain patients directly or prevent them from having access if they live in a state that currently allows them to legally use marijuana.
Ms. Carreno also pointed out that the job of the DEA is not to focus on individuals or caregivers, but rather “to protect Americans from those who would exploit them for money. That is the purpose of all that we do.” She noted that this translates into going after large-scale drug rings and illegal activity, not taking actions that would keep Americans from much-needed pain medications. “We just want to know that any pain medication [they use] is safe.” That’s why the government’s focus on understanding the safety and efficacy is essential, she stressed. In fact, she said this is why the DEA supports continuing scientific research that could ultimately lead to changing marijuana’s classification in the future.
Seeking Better Understanding
In a letter to petitioners published in the Federal Register on August 11, 2016,2 explaining the agency’s denial to reclassify marijuana, the DEA’s acting administrator, Chuck Rosenberg, also reiterated the DEA’s commitment to furthering the knowledge base around marijuana. “During the last 2 plus years,” he wrote, “the total number of individuals and institutions registered with DEA to research marijuana, marijuana extracts, derivatives, and tetrahydrocannabinols (THC) [a component of the cannabis plant] has more than doubled, from 161 in April 2014 to 354 at present.”
Mr. Rosenberg also noted, “We will continue to work with NIDA [the National Institute on Drug Abuse] to ensure that there is a sufficient supply of marijuana and its derivatives (in terms of quantity and the variety of chemical constituents) to support legitimate research needs. This includes approving additional growers of marijuana to supply researchers.”
Hope for the Future
Barth Wilsey, MD, a clinical investigator at the University of California (UC) Center for Medicinal Cannabis, UC San Diego, weighed in on the DEA’s response, agreeing that changes in the approval of additional growers of marijuana to supply researchers could potentially be beneficial. “But this depends upon how attractive this will be for universities, pharmaceutical companies, and other eligible entities to invest in plant cultivation,” he pointed out.
“In addition, the cost of large scale clinical trials of the type required for FDA approval will be formidable. However, there is precedent for such endeavors; GW Pharmaceuticals in Great Britain has been developing cannabinoid medications for quite a few years. It will be interesting to see if the investment necessary to grow plants and perform clinical trials for different cannabis strains begins to gather momentum in the United States,” he said.
Dr. Wilsey also pointed out that NIDA is currently the primary source of funding for therapeutic cannabis studies among National Institutes of Health. NIDA recently asked researchers to submit information on new strains that they would like to see grown for use in clinical trials. In addition, a couple of states (i.e., California and Colorado) have previously indicated a willingness to support clinical research involving medicinal cannabis.
“They and others may consider the option of funding the cultivation of new strains of cannabis. Presumably, this would be through the use of excise taxes collected on recreational cannabis. All of this portends for a promising future for research into medicinal cannabis,” Dr. Wilsey said.
And of course the hope is that if the research can ultimately show that marijuana is safe and effective in treating pain, it may lead to reclassification in the future.