The press conference last Friday held by two New York state assemblymen was no doubt timed to coincide with observance of the 4/20 celebratory day in cannabis counterculture: On 20 April the duo announced a bill that would make New York the 41st state to deem possession or sale of the active ingredients in so-called ‘synthetic marijuana’ drugs a crime punishable by jail time. The drugs in question—known to the mostly teenagers who like to smoke them as K2, Spice, Killer Buzzz, Blaze and Mr. Nice Guy—are mixtures of herbs such as oregano laced with laboratory-produced cannabinoids, a class of chemicals that also includes marijuana’s psychoactive component, tetrahydrocannabinol (THC).
The dangers of synthetic cannabinoids are clear. A study published this month in Pediatrics documented more than 4,000 US hospital cases in which teens who used K2 and other drugs required emergency intervention for symptoms such as a dangerously rapid heart rate. But medical researchers warn that the march toward nationwide criminalization that started with a 2010 Kansas law banning three synthetic cannabinoids has already begun to stifle research on the chemicals, which are known to stimulate appetite and ameliorate nausea and pain. “It would be a disaster if they criminalized all synthetic cannabinoids,” says pharmacologist Nathan Lents at the City University of New York. “We already have to jump through hoops to do our research. These substances clearly have untapped potential as therapies.”
Therapeutic benefits aside, momentum is growing for broad criminalization not only among states but at the federal level. A US Senate bill introduced last March by Charles Schumer, a Democrat from New York, would criminalize all synthetic cannabinoids nationwide. “That would be so traumatic,” explains Lents, “because that law classifies all cannabinoids as schedule 1 drugs.” A ‘schedule 1’ drug has no known medical use, and so is very tightly controlled by the federal government. A researcher conducting experiments with any schedule 1 substance must submit protocols signed by the president of his university to the US Drug Enforcement Agency in order to obtain small amounts of the chemical, which then must be kept locked in a safe when not in use, and must fill out mountains of paperwork accounting for the chemical’s use in experiments. Lents says requiring researchers to jump through such hoops chokes research and draws already spare funding away from cannabinoid labs. “There’s already not a lot of political will because these substances are seen as somehow morally reprehensible. A schedule 1 designation would make it even harder to study them.”
However, some experts say time-consuming bureaucratic safeguards are a reasonable price to pay for protecting citizens from drugs like K2. “These are toxic substances,” says Jeffery Moran, the branch chief at the Arkansas Department of Health’s public health laboratory in Little Rock and the author of a recent commentary in Nature Medicine on the subject. “Yes, there’s added time and cost, but in pharmacology research groups that work on controlled substances, the protocols should already be in place.” Moran points out that the federal government already went ahead and classified three synthetic cannabinoid chemicals as schedule 1 in March of last year. “The federal regulations started more than a year ago, but I haven’t seen the rate of publications on these substances slow down one bit,” he says.
But while primary research may still be going strong, cannabinoid drug development in the US does not seem to be delivering. The two synthetic cannabinoid therapies currently approved by the country’s Food and Drug Administration (FDA) are the more than 25-year-old THC analogs Cesamet, marketed by Valeant Pharmaceuticals of Canada, and Belgian Solvay’s drug Marinol. A third cannabinoid therapy, a muscle-calming inhaler for people with multiple sclerosis made by British GW Pharma, is in phase 3 clinical trials in the US.
According to the FDA’s records, no US company has filed an application for a new synthetic cannabinoid in the past decade. It is not for lack of a market, says Lents. “There is still a large unmet medical need among people with wasting diseases,” such as anorexia, cancer and AIDS, he says, and synthetic cannabinoids are the only chemicals known to both decrease nausea and stimulate the appetite. “A blanket ban will just slow down medical research further,” he says.
Photo courtesy of the Public Intelligence Research Project