DEA decision keeps major restrictions in place on marijuana research

Federal drug enforcement authorities announced Thursday that they would continue defining marijuana as a drug with a high potential for abuse and no accepted medical value, a decision that keeps in place significant restrictions on biomedical research.

The decision by the Drug Enforcement Administration means marijuana will remain classified as a Schedule 1 drug.

Many scientists have been calling for the federal government to reschedule the drug, which they said would open the door to more medical research into marijuana and its potential effects, both beneficial and harmful.

To conduct research with Schedule 1 drugs, scientists have to gain DEA approval and often upgrade the security protocols in their labs, expensive and time-consuming hurdles.

Scientists have argued that thorough research is all the more important with medical marijuana available in 25 states and Washington D.C., and a small number of states starting to legalize recreational marijuana as well.

The DEA’s announcement came in response to a 2011 request from the then-governors of Washington and Rhode Island to have marijuana and its “related items” moved to Schedule 2. In its response, posted in the Federal Register, DEA acting administrator Chuck Rosenberg wrote that federal health officials recommended marijuana stay at Schedule 1 after concluding that the drug has “no accepted medical use in the United States.”

With that finding, authorities said they could not have moved marijuana to a Schedule 2 drug, which is legally defined by the Controlled Substances Act as having some medical value.

“This decision isn’t based on danger,” Rosenberg told NPR. “This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine, and it’s not.”

In a recent review of research, the Department of Health and Human Services found that scientists do not understand the drug’s chemistry and haven’t conducted adequate safety and efficacy studies, according to Rosenberg’s letter. Of course, proponents of rescheduling marijuana point to that as a direct effect of the restrictions on marijuana research. If scientists can’t study marijuana, they say, they are not going to be able to learn much about it.

The DEA, however, did announce it was going to “take steps … to increase the lawful supply of marijuana available to researchers.” In another memo, Rosenberg wrote that federal authorities would allow more sites to grow marijuana for federally approved research. Currently, researchers have to obtain their supply from a program at the University of Mississippi that has an exclusive contract with the National Institute on Drug Abuse.

Rosenberg wrote that federal agencies are seeing a growing demand from researchers for marijuana with which to conduct research. Now, additional growers can apply to register with the DEA to supply marijuana not just for federally sanctioned research projects, but also for drug development.

“Although no drug product made from marijuana has yet been shown to be safe and effective in such clinical trials, DEA — along with the Food and Drug Administration and the National Institutes of Health — fully supports expanding research into the potential medical utility of marijuana and its chemical constituents,” Rosenberg wrote.

(The DEA chief did note, however, that federal health officials have approved two synthetic drugs — Marinol and Cesamet — that resemble or are identical to THC, a component of marijuana that gives users a high. The drugs, which treat nausea from chemotherapy among other conditions, are listed as Schedule 3 and Schedule 2, respectively, because they have shown some medical value.)

In a Thursday blog post, John Hudak, a senior fellow in governance studies at the Brookings Institution, wrote that the “NIDA monopoly” at the University of Mississippi had led to slow delivery of marijuana and a limit on what kind of marijuana strains were grown and could be obtained, which amounted to “holding science back.” By enabling more research with a broader scope, the increase in supply could actually advance scientific understanding enough to the point that marijuana can be rescheduled, Hudak wrote.

Not rescheduling marijuana “will certainly disappoint many in the marijuana reform community,” Hudak wrote. But he added that the “DEA, in a clear sign of the growing political complexity around cannabis policy in the United States, will strike a balance” by opening the door to more marijuana supply.

Dr. Orrin Devinsky, a neurologist at New York University Langone Medical Center who has called for relaxed restrictions on marijuana research, said the key problem was that researchers have to take many steps before being allowed to conduct research with marijuana. That includes meeting with state and federal agents, additional reviews of study proposals, and sometimes buying new safes or security cameras for the research center’s pharmacy.

“The main holdup for researchers is the scheduling, not the ability to obtain the product, which is a secondary issue,” Devinsky said. “This change is a positive one, but will do relatively little to advance our scientific understanding.”

Bertha Madras, an addiction researcher at Harvard Medical School who supports keeping marijuana as a Schedule 1 drug, said that expanding the number of suppliers should allow researchers to study other strains with different levels of THC and other compounds.

But she added that “this new direction needs oversight and vigilance to ensure that high quality science will be applied with these new sources of the plant.”

Proponents of keeping marijuana classified at Schedule 1 say the extra steps are a reasonable precaution for researchers to take given that it’s a substance shown to have some negative impact on developing brains and given that some people become dependent on it.

They argue regulations have not completely stalled research with marijuana. Companies have sponsored clinical trials of drug candidates made from marijuana, and according to the DEA, the number of scientists registered to study the substance rose from 161 in April 2014 to 244 in March 2016.

Researchers also need the highest level of permission to run clinical trials of marijuana and drugs derived from it, and to study constituents of marijuana, even if they are free of the components that make people high.

A component of marijuana called cannabidiol has shown promise in treating people with epilepsy, and other researchers want to study marijuana as a potential therapy for post-traumatic stress disorder and for pain.

Other Schedule 1 drugs include heroin and some hallucinogens. Cocaine, methamphetamine, and opioids are considered Schedule 2 drugs because they have been found to have some accepted use in medicine.