Summary: The New York Times reports on the U.S. Drug Enforcement Administration (DEA)’s decision against removing marijuana from the list of Schedule I substances due to a lack of medical research. MAPS Founder Rick Doblin, Ph.D., details how conducting marijuana research can lead to federal approval of medical marijuana, stating, “If you make it through the F.D.A.,” explains Doblin, “insurance companies will cover it.”
Originally appearing here.
The Drug Enforcement Administration’s decision on Thursday to not remove marijuana from the list of the nation’s most dangerous drugs outraged scientists, public officials and advocates who have argued that the federal government should recognize that marijuana is medically useful.
Reclassifying marijuana from a Schedule 1 drug to a Schedule 2 drug would have made it easier to get federal approval for studies of its uses and paved the way for doctors to eventually write prescriptions for marijuana-derived products that could be filled at pharmacies, like other Schedule 2 drugs such as Adderall, which is used to treat attention deficit hyperactivity disorder.
Eight Democratic legislators had urged the D.E.A. to reclassify marijuana to a Schedule 2 drug. Senator Elizabeth Warren of Massachusetts voiced her disappointment with the decision on Twitter. Senator Kirsten Gillibrand of New York said in a statement, “It shouldn’t take an act of Congress for the D.E.A. to get past antiquated ideology and make this change.”
Yet in a separate policy proposal also issued on Thursday, the agency handed researchers and advocates a victory in removing a significant roadblock to medical studies of marijuana. The D.E.A. said it will allow universities and even private companies to apply to grow marijuana for scientific research. For many years, the University of Mississippi has had a monopoly on that role as the sole D.E.A.-approved provider of marijuana, and researchers have long complained that the supply of the drug was grossly inadequate, stymying efforts to establish whether marijuana is an effective treatment for many diseases.
Chuck Rosenberg, the acting head of the D.E.A., wrote in the decision that marijuana would remain a Schedule 1 drug because “it has no currently accepted medical use in treatment in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.” He said these criteria are set out in the Controlled Substances Act, which mandates scheduling decisions based on scientific data.
“Research is the bedrock of science,” he wrote, “and we will — as we have for many years — support and promote legitimate research regarding marijuana and its constituent parts.”
The District of Columbia and 25 states now allow the use of marijuana for a wide variety of medical conditions. The scientific evidence of its effectiveness is thin to nonexistent for many illnesses, including rheumatoid arthritis, Tourette’s syndrome and lupus. Reputable studies have shown it can relieve nausea, improve appetite and ease painful spasms.
But there is no drug derived from marijuana that has yet been approved by the Food and Drug Administration.
Under the previous policy, marijuana supplied by the University of Mississippi could not be used legally to develop marijuana-derived drugs for F.D.A. approval and for eventual commercial sale. The new policy changes that. Marijuana grown by approved institutions will qualify for use in clinical trials seeking the approval of federal regulators, and can be marketed.
Some experts and advocates argued that ending the University of Mississippi’s de facto monopoly on growing research-grade marijuana was more important to spurring research than reclassifying the drug. Paul Armentano, the deputy director of the National Organization for the Reform of Marijuana Laws, said that “removing this arbitrary hurdle to research could have more significant ramifications than simply rescheduling from 1 to 2.”
Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies, which is funding a trial of marijuana as a treatment for post-traumatic stress disorder in veterans, agreed. “That was the key obstruction,” he said.
Michael Felberbaum, an F.D.A. spokesman, said on Thursday, “We continue to encourage work to assess whether there are appropriate and effective therapeutic uses of marijuana and its components and believe the drug approval process using scientifically valid and well-controlled clinical trials is the most appropriate way for this to occur.”
Currently Epidiolex, a marijuana-derived liquid, is going through clinical trials to determine its effectiveness and safety for the treatment of seizures in children. It uses cannabidiol, an ingredient in marijuana also known as CBD, that does not induce a high. Mr. Rosenberg said in his letter that if CBD proved safe and effective for the treatment of childhood epilepsy, “that would be a wonderful and welcome development.”
Some drug policy experts nonetheless said the refusal to reschedule marijuana would hamper research. “They are placing researchers in a Catch 22, by saying ‘We are not lifting this research barrier because there’s not enough evidence.’ But then people say, ‘We can’t do research because of this barrier,’” said Michael Collins, the deputy director of national affairs at the Drug Policy Alliance, which supports the legalization of marijuana.
Others were thrilled the D.E.A. did not budge. “At present, rigorous evidence does not support the use of marijuana for medical conditions, especially as short- and long-term consequences are not adequately documented in patients,” said Bertha K. Madras, a professor of psychobiology at Harvard Medical School. “Increasingly, scientific evidence shows marijuana to be harmful, and especially for young people.” She called the agency’s decision “a victory for science that, to me, is very comforting.”
But the key question now is funding, Dr. Doblin said. Will drug companies spend large sums to run clinical trials to develop marijuana-derived medicines?
“One competitive advantage, if you make it through the F.D.A., is insurance companies will cover it,” Dr. Doblin said. But he added that the potential disincentive was obvious: Marijuana is widely available on the street and many states have approved the sale of marijuana for medical purposes.