Summary: International Business Times speaks with MAPS-sponsored researcher Marcel Bonn-Miller, Ph.D., about MAPS’ upcoming clinical study of medical marijuana as a treatment for symptoms of posttraumatic stress disorder (PTSD). “We are very clear that we are taking an unbiased approach and following the highest and most rigorous standards and will publish whatever comes out,” explains Bonn-Miller.
Originally appearing here.
For years, Lisa Tollner, co-founder of the California marijuana edibles company Sensi Products, says she’s received calls and emails from customers reporting her cannabis-infused Sensi Chew caramels had helped alleviate pain, insomnia, nausea and other ailments. But Tollner wanted more.
“These people are telling me their stories, but with no real consistency,” said Tollner, who was interested in hard data on how her products worked, not shifting anecdotal evidence. “I need ways to prove our products’ efficacy.”
While 25 states plus Washington, D.C., have legalized medical marijuana, fueling an exploding marijuana market that took in just under $1 billion in sales last year, the science underpinning cannabis products has so far outpaced the industry that’s grown up around them.
That’s why Tollner has agreed to take part in one of the first scientific endeavors of the Institute For Research On Cannabinoids (IROC), a nonprofit scientific organization that’s the first of its kind in the country. In an exclusive to International Business Times, IROC Executive Director Marcel Bonn-Miller, a professor at the University of Pennsylvania’s Perelman School of Medicine, said the institute will bring together many of the world’s top marijuana scientists to undertake unique cutting-edge cannabis studies.
IROC is part of a research trend that’s seen cannabis-focused scientific endeavors launch in several countries, including Australia and the Czech Republic. The group’s founders aim not just to fill in the scientific gaps in what we know about cannabis’ potential benefits and risks, but also find innovative ways to score funding that marijuana researchers say is desperately lacking in their line of work.
“With any other drug, the research comes before it reaches a patient,” said Bonn-Miller. “With cannabis, it’s completely the opposite. It’s in the hands of everybody, but nobody knows about dosing, nobody knows the best methods of delivery, nobody knows what strains are best for different uses. The cart is so far before the horse in terms of the gap between research and policy.”
To help close that gap, Tollner will partner with IROC on an online survey of thousands of medical marijuana patients across California that will track their medical marijuana use and its effects over a six-month period. The study, which has been submitted to Stanford University’s institutional review board for added credibility, will cost Tollner $15,000 — a fraction of what research like this usually costs. The results, said Tollner, won’t just benefit Sensi Products — it will help the industry as a whole. “Everyone will be able to mine this new data,” she said. “There will be good data and good stories and papers that can be written for the medical community.”
A clinical psychologist by training, Bonn-Miller has been studying cannabis for 10 years. He’s published more than 100 peer-reviewed journal articles on his research and serves on the board of six academic journals, including “Cannabis and Cannabinoid Research,” a peer-reviewed open-access publication on the field. At first, he didn’t have trouble obtaining funding for his work, receiving dozens of grants from the likes of the Department of Veterans Affairs and the California HIV/AIDS Research Program. But that was when he focused his studies on the potential negative consequences of marijuana, such as how the drug might lead to cannabis use disorder and in some cases exacerbate anxiety disorders and post-traumatic stress disorder. But that started to change five years ago when he became increasingly interested in marijuana’s potential therapeutic uses as well.
“I’d been at the Department of Veterans Affairs and some veterans were coming out and saying, ‘This is helping me. If I didn’t have marijuana I wouldn’t be alive,’ ” he said. “I think the problems associated with marijuana are real, but we need to understand the other side of the coin.”
But he soon discovered money to increase people’s understanding of marijuana’s therapeutic potential was essentially nonexistent. There were no funding mechanisms at all, he said. “From the National Institutes of Health to the VA to whatever, there was nothing.”
The obstacles to studying marijuana’s potential benefits are myriad, said Ethan Russo, medical director at the Los Angeles biotechnology firm Phytecs, who has been researching marijuana for 20 years. For starters, said Russo, because of long-held social stigmas around marijuana, most funding operations aren’t interested in studying the drug’s positive aspects. It doesn’t help that the only supply of marijuana available for researchers is overseen by the National Institute of Drug Abuse (NIDA), which because of its mandate appears more inclined to support studies focusing on marijuana abuse and addiction than its therapeutic features. While the Obama administration removed one of the barriers to obtaining marijuana for research last year, gaining access to NIDA’s limited supply of cannabis is still a lengthy and difficult process.
Then there’s the fact that the National Institutes of Health (NIH), a major funder of biomedical research, has faced increasing grant applications as its budget has remained flat or declined, meaning the percentage of research projects it approves dropped from 34 percent in 1999 to 19 percent in 2012. “Traditionally, if you had a compelling reason to do research, you could get funding,” Russo said. “Now nothing is getting funded unless you have something really sexy. And marijuana is like kryptonite.”
Finally, while marijuana companies could fund studies on their products similar to pharmaceutical companies, the legal restrictions around marijuana make it difficult for businesses to do so. “Let’s suppose my company has an extract of cannabis that would be fantastic for treating pain. We currently cannot take that over state lines, we cannot use it in clinical trials elsewhere, and we cannot export it,” Russo said. “It’s not only anti-science, it’s anti-business. American companies are not able to compete in the marketplace of ideas in the world.”
Forming the Dream Team
Bonn-Miller has found some success scoring funding to study marijuana’s therapeutic promise. When the Colorado Board of Health awarded roughly $8 million in medical marijuana research grants in late 2014, the largest chunk went to the Multidisciplinary Association for Psychedelic Studies to study whether marijuana was helpful in treating PTSD, with Bonn-Miller as the lead investigator. The resulting randomized control trial of veterans using marijuana, which has been beset with controversy and delays since it was first proposed by Bonn-Miller’s research colleague Sue Sisley in 2010, is scheduled to launch within the next month.
Bonn-Miller has also received interest in funding studies from marijuana companies like Sensi Products, but on their own, none has the sort of resources to bankroll the major research projects he’s interested in. “For $5,000, $10,000 you’re talking observational studies,” he said. “But what you really need are clinical trials and those you can’t do for that amount.” Several recent reviews of marijuana research found that randomized controlled trials, the go
ld standard for scientific evidence, are exceedingly rare in the field. According to IROC, there have been only four controlled trials, involving 225 total participants, on marijuana’s potential for appetite stimulation for those diagnosed with HIV or AIDS. There has been only one trial, comprised of nine people, on marijuana and cancer.
“We need a space to pull in money from lots of different sources and combine it to do rock star studies,” Bonn-Miller said. That’s why two months ago he began developing IROC.
“I’m super excited about it,” said Ryan Vandrey, associate professor at Johns Hopkins University School of Medicine in Baltimore, who, as a close collaborator of Bonn-Miller, was one of the first to learn of the plan. “We want to try to form a place where a state that is considering a new medical marijuana program can go to obtain expertise and data to inform their policies. We want to provide a spot for people who are interested in making donations for advancing the science but don’t know where to go or who to contact about it. And we also wanted to create a think tank of international scientists who are aware of what’s going on and can establish research priorities and put the dollars to good use.”
Realm of Caring, the Colorado nonprofit behind Charlotte’s Web, the marijuana strain that’s become famous for helping children with epilepsy and other ailments, provided the institute with an office in Colorado Springs, although most of the organization’s work will be done remotely. And to fill out the institute’s ranks, Bonn-Miller and Vandrey reached out to a who’s who of marijuana researchers around the world, including Russo in California, Mahmoud ElSohl, who produces and oversees NIDA’s supply of research marijuana at the University of Mississippi, and Brian Thomas, a principal scientist at RTI International who has long handled the preparation of all NIDA marijuana samples. (“I like to say I have rolled millions of marijuana cigarettes,” said Thomas, who’s an expert in how properly to formulate marijuana for scientific studies, something he says can be a problem in cannabis research.)
Everyone contacted said yes.
IROC isn’t the only new institute focused on cannabis science. Last year, the International Cannabis and Cannabinoid Institute research center launched in the Czech Republic and the Lambert Initiative for Cannabinoid Therapeutics opened its doors at the University of Sydney. And just last month, Thomas Jefferson University in Philadelphia unveiled the Center for Medical Cannabis Education & Research (CMCER).
“There is growing momentum to create and develop these kinds of programs,” said McGill University professor Mark Ware, executive director of the Canadian Consortium for the Investigation of Cannabinoids and now a member of IROC’s scientific board. “The dialogue nationally and internationally around cannabis has reached a point where it is no longer possible to ignore it. And secondly, there is an industry emerging around medical cannabis. I think you put these two things together, and it’s a perfect storm.”
While CMCER will be focused mainly on educating healthcare clinicians and the public on medical uses of marijuana, Bonn-Miller said IROC, which is working in partnership with the institutes in Australia and the Czech Republic, is interested in filling in research gaps. Among its top priorities are clinical trials on cannabis’ effects on depression, HIV/AIDS, cancer and opioid addiction. The institute has already started work on the first-ever study of marijuana’s impact on chronic pain and brain injuries among football players, courtesy of a $100,000 fundraising campaign helmed by Realm of Caring, $80,000 of which came from Baltimore Ravens offensive tackle and cannabis advocate Eugene Monroe.
But Bonn-Miller knows much more money needs to be raised.
“We are reaching out to individuals with large pockets and medium-sized businesses in this space that are interested in doing this kind of work,” he said.
He knows bias can be a concern when scientists partner with commercial interests, but he insists IROC will remain independent and objective.
“We are very clear that we are taking an unbiased approach and following the highest and most rigorous standards and will publish whatever comes out,” he said. “I believe for some conditions we will find some therapeutic benefits of marijuana, but I am not under the illusion that we are not going to find some countraindications.”
Tollner of Sensi Products concedes one of the reasons she’s collaborating with IROC on the study of medical marijuana users is to expose more people to her caramels. As an incentive, study participants will receive coupons for free Sensi Chews. But she’s not interested in science that simply promotes her products; after all, only a small fraction of the thousands of patients surveyed will likely have consumed her edibles.
“I don’t want skewed data,” she said. “I just don’t want people to put something in their body that’s fake.”