Is cannabis—now legal in many states—set to enter mainstream research and development, possibly taking over pain control where opioids left off in the market? Or seizure disorders? Severe nausea? Glaucoma?
Many researchers are working to bring cannabis and cannabinoids into the mainstream medicine chest. Others feel that cannabis is such a different animal, with so much baggage, that the roadblocks it faces to becoming an accepted medicine in the U.S. may be, for the time being, insurmountable.
The National Academies of Sciences, Engineering and Medicine is one body that’s poised for the growth of cannabis in the market. The committee conducted a comprehensive review of the research on cannabis and cannabis-derived products since 1999, and earlier this year published a landmark report that proposed ways to expand and improve the quality of cannabis research efforts and addressed the current barriers.
The report pointed to chronic pain in adults, multiple sclerosis-related muscle spasms and chemotherapy-induced nausea and vomiting as areas where cannabis and cannabinoids have thus proved effective.
The biggest issue with the full-steam forward movement for cannabis, though, is funding, says Sabrina Ramkellawan, co-founder and clinical research consultant at the Canadian Institute for Medical Advancement, and vice president for the Canadian Research Association, who began working on research into cannabis three years ago.
“When Pfizer does a study on a novel compound, they will spend money because they will get it back, but you can’t patent weed,” she said. Therefore, there may not be big money to be made for pharma—at least not in plant-based preparations. Instead companies are working to patent technology around transforming the cannabis plant into substances that can be consumed and have standardized bioavailability.
Many medical marijuana companies are conducting trials around proof-of-concept. The goal is to show that their strain of cannabis works better than competitors’ so that doctors who prescribe medical marijuana have data to go on, said Ramkellawan, who formerly was head of operations in Canada for INC Research.
And there are lots of competitors in the U.S. at present. In 2016, medical marijuana became legal in half of the 50 states. Additionally, eight states and Washington, D.C., allow adult-use recreational marijuana.
At present controlled studies on cannabis have mostly been small, said Ramkellawan. More common still are observational studies, she said, some of which she’s designed. But more trials of both kinds are in the works.
“The non-addictive nature of cannabis makes it a prime candidate to help address the opioid crisis that has crippled society,” said Prateek Dwivedi, CEO of Ehave, a company that works on technology to capture phase IV trial clinical trial grade data on cannabis.
Said Dwivedi, the FDA may not regulate cannabis now, but one day they will, and companies that make it need to be ready with, ideally, years of clean data.
Guillermo Moreno, a renowned cannabis researcher focused on its analgesic affects, formerly at the University of California, Irvine, and now working on new projects in Spain, said that medical research into the plant can be very challenging in the U.S.
Explains Moreno, to study cannabis, the plant, after initial FDA review of your protocol, you must apply for a license from the Drug Enforcement Administration (DEA), which can take years. And once granted a license, you must obtain your material from the National Institute on Drug Abuse (NIDA) which has a contract with the University of Mississippi. Unfortunately, said Moreno, the cannabis that originates there can and often does arrive frozen, dried out or moldy, and also quite weak, all of which can make it unsuitable for research. Many researchers instead choose to conduct their research on whole-plant preparations outside of the U.S. If this medical research protocol continues the way it has, he said, the U.S. will fall behind in this promising market.
Moreno added that what does show promise for pharma companies is the creation of synthetic versions of the active agents in cannabis. For example, Marinol, a synthetic version of THC, was approved by the FDA to treat loss of appetite that causes weight loss in people with AIDS. It’s also used to treat severe nausea and vomiting caused by cancer chemotherapy. A similar drug is Syndros. Thus far, those are the only two with FDA approval.
John Stewart, president and CEO of Purdue Pharma, makers of the narcotic painkiller Oxycontin, left the company in 2013 and co-founded Emblem, a medical marijuana company based in Ontario. Ramkellawan predicts that there will be similar movement from the field and from the CRO industry. She took on a cannabis trial three years ago and never looked back.
“I saw an epileptic child do so much better, I had an older lady with fibromyalgia and other crippling conditions say she could put her cane down and dance at her child’s wedding,” Ramkellawan said. “I couldn’t believe a lot of what I was seeing. There was strong anecdotal evidence walking around right in front of me.
“I think cannabis is going to be a huge disruptor to the pharma side,” she said.
This article was reprinted from Volume 21, Issue 22, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »