MAPS made some tweaks to its study design and got the OK from the Public Health Service. Just last month, the group secured its first marijuana to use in research. A study testing the drug’s effects on 56 veterans with post-traumatic stress disorder is gearing up to launch.
“It’s taken us 23 years,” Doblin said wearily.
MAPS has reason to be frustrated with the single-source system, and some academic researchers share Doblin’s complaints. Much of the most promising recent research on medical marijuana focuses on cannabidiol, or CBD, a non-psychoactive ingredient.
The British drug company GW Pharmaceuticals began testing a mixed CBD/THC product in 1998. But NIDA only began measuring and controlling the concentration of CBD in its supply earlier this year. Researchers interested in the possible uses of any of the other 70-plus ingredients in marijuana have nowhere to turn.
After its phase 2 study is complete, MAPS will have to look for another legal source of cannabis. NIDA doesn’t supply the drug for commercial purposes, and MAPS wants to get FDA approved to sell cannabis as a prescription medication. For any drug to get FDA approval, the product tested in the phase 3 trial must be exactly what will be brought to market. Government pot won’t do.
The number of bureaucratic hurdles has led some groups to allege the federal government purposely blocks research into medical uses of marijuana, a charge government agencies have denied. Earlier this month, the government said it would more than double its planned 2015 production of marijuana for medical research.
Federal agencies may be turning away from the “reefer madness” biases of their past, but now the floodgates are open and a patchwork of state programs that supply marijuana directly to patients has stepped in to fill the void.
Though it is easy for Keller to get marijuana, it’s not cheap. He pays about $400 a month out of pocket. Keller would ideally like to be allowed to grow the plant himself, he said. He’d rather go through standard medical and insurance channels.
Keller isn’t alone. The American Academy of Pediatrics and the Epilepsy Foundation say they support the development of cannabis-based drugs under the FDA process.
Last year, The New York Times reported that one family’s public success using a high-CBD strain of marijuana oil to bring their young daughter’s seizures under control was driving a migration of families with children with severe seizure disorders to Colorado. Drs. Orrin Devinsky and Daniel Friedman of New York University’s Comprehensive Epilepsy Center responded with an op-ed in the same paper urging caution.
“The truth is we lack evidence not only for the efficacy of marijuana, but also for its safety,” especially in children, the doctors wrote. “It is troubling that while few barriers exist for parents to give their children marijuana in Colorado, there are significant federal roadblocks preventing doctors from studying it in a rigorous scientific manner.”
Patients have the most to gain from access, which comes with more information about marijuana’s medicinal properties — and its potential side effects.
“I think there’s tremendous value in the clinical trial process,” said Kenneth Kaitin, Ph.D., director of the Center for Drug Development at Tufts University. “You’d understand the clinical pharmacology of the drug, a lot about the correct mode of administration, and more about effects and side effects. That all comes about with rigorous clinical trials, and in many respects if you’re a patient I think you’re better served by having something that’s gone through that process.”
Experiences like Keller’s demonstrate that marijuana can have concrete medical benefits for some patients, and they shouldn’t be kept in the dark about what they’re putting into their bodies.
“There are some states that are trying very hard to regulate the production and quality of the product, but there’s certainly a huge gap in terms of what states are doing versus what the FDA does in pharmaceuticals,” said Hudak, of the Brookings Institution. “I think there is a lot of space to improve the quality of testing, titrating and dosing when it comes to medical cannabis.”