Last week John Hopkins University in Baltimore pulled out of a study testing medical marijuana and Veterans with Post-Traumatic Stress Disorder. They said they no longer felt aligned with the trial’s administrator, the Multidisciplinary Association for Psychedelic Studies (MAPS). But the university’s decision reflects a deeper tension between the various bodies involved in medical cannabis research in the United States.
That’s because in the US, despite almost half its states having Compassionate Access Programs for medical marijuana, research is notoriously difficult to carry out and some suggest, even doomed to failure.
Much stems from the cannabis plant’s Schedule 1 status. Deemed as having no therapeutic effect and liable to abuse, this sets the various government agencies’ modus operandi of proving beyond all reasonable doubt that cannabis is a dangerous drug rather than a medicinal one.
Federal monopoly supplies substandard cannabis to researchers
Take for instance the cannabis plant material used for any federally approved research. For almost 50 years a monopoly has been in place in the United States in which the University of Mississippi has been the only licensed supplier of marijuana for research purposes, thanks to a contract with NIDA – the National Institute on Drug Abuse. Cannabis is the only drug where this monopoly exists.
Much criticism has been levelled at the lack of supply and limited variety of strains provided by the university. But it was the recent John Hopkins University/ MAPS PTSD stage 2 clinical trial under lead researcher Sue Sisley that drew particular attention to the poor quality of the plant material provided.
Official samples poor quality and contaminated by mold
In an interview with PBS, Sisley revealed her horror when after two years of waiting for the trials to begin, she received the first delivery from the federally approved supplier. Instead of the pungent buds and flowers available on the commercial market, she was confronted with what looked like lawn clippings. “It didn’t resemble cannabis. It didn’t smell like cannabis,” Sisley told PBS.
Not only that, but when the samples were tested, they were found to contain mold, traces of lead, and were below the cannabinoid levels requested for the study. Incensed, Sisley went public. And not long after John Hopkins University pulled out, possibly embarrassed by the overt disdain shown by Sisley and MAPS towards the Federal Government approved supplier. In an interview MAPS Director Doblin pulled no punches when he said, “NIDA is completely inadequate as a source of marijuana for drug development research.”
NIDA has rebutted the accusations saying that the mold was probably caused by a mishandling on the part of Sisley’s team and they will be looking into the other discrepancies.
Catch 22 situation limits research success
Despite the absence of John Hopkins, the phase 2 trial will still go ahead. However, if it does manage to prove the safety and efficacy of medical cannabis for PTSD and move onto the 3rd stage, it will inevitably be met by yet another stumbling block.
That’s because the marijuana supplied by NIDA and the University of Mississippi for research purposes cannot be used for prescription sales, and the FDA would therefore not accept the federally supplied marijuana for any final Stage 3 clinical trials, making it effectively a Catch 22 situation. Little wonder then that no medical drug made from cannabis has jumped through the impossible hoops and got FDA approval.
DEA finally ends monopoly
However, it seems the DEA may be softening its position, allowing for a potential exit from this impossible situation.
In August last year, they announced their intention to grant licenses to other marijuana growers to supply the burgeoning demand for medical cannabis research. So far 16 applications have been made, including the Scottsdale Research Institute where Sisley is lead investigator, who propose the more sterile method of growing cannabis from tissue culture rather than seedlings. As yet, no licenses have been granted.
While the DEA say there is no official timeline, campaigners are hopeful that as research material and variety of strains improve, so will the results of investigations, which could possibly herald a reclassification of cannabis and free it from its schedule 1 straight jacket.
Congressional change the only answer?
Jahan Marcu, Senior Scientist at America for Safe Access is not so sure. He says, “drugs are designed in the United States to go into Schedule 1, they’re not designed to come out of it. So it’s only going to come from an act of Congress, because these agencies have shown that they’re quite incapable of taking in any new information, making serious, pragmatic, critical assessments, and instead rely on fear and outdated information. I prefer health policies that weren’t made 100 years ago.”
While federal policy appears up for grabs under the Trump administration, Congress has taken action by forming a Cannabis Caucus, as well as introducing the bill, “Ending Marijuana Prohibition Act of 2017,”which would remove cannabis from the Federal Controlled Substance Act, allowing each individual state to decide how best to schedule it.
Right now though, all eyes remain on the Washington, and only time will tell whether the federal trimpherate of the FDA, DEA and NIH (National Institute of Health) will match their recent proclamation to “fully support expanding research into the potential medical utility of marijuana and its chemical constituents,” allowing common sense to finally prevail in the world of medical cannabis research.