Monday, 1 July 2019

Cannabis Overhype, FDA-Approved Tripping, And More High-Minded Findings From The Aspen Ideas Festival

Katie Shapiro

Summer festival season is in full swing in high country and on the heels of the groundbreaking debut of cannabis at the Food & Wine Classic in Aspen came the 15th annual Aspen Ideas Festival, which reached a milestone of its own in presenting the two dedicated discussions on cannabidiols and psychedelics. 

The ten-day event is produced by the Aspen Institute, the nonprofit educational and policy studies organization based in Washington, D.C., and welcomes more than 400 of the world’s most prominent thought leaders spanning business, politics, media, culture, and science as speakers for its 3,000 registered attendees and invited scholars.

“Every year, Aspen Ideas: Health focuses on some of the hot button issues in health and medicine, says Ruth Katz, Director of the Health, Medicine and Society Program at the Aspen Institute. “CBD and psychedelics are among those for 2019, as the sold-out audiences for both of these sessions clearly demonstrate. As always, in selecting our speakers, we look for the best in the business—those who are recognized as leaders in the field.”
As part of Aspen Ideas: Health, a prequel track of programming which ran from June 20-23, organizers addressed the explosion of the cannabis plant derivative everywhere, in “CBD: Hype or Hope?,” which according to the official description, begged the question, “The U.S. Food and Drug Administration held its first public hearing on CBD in early June, but doesn’t yet regulate the product, and concerns about mislabeling and other hazards abound. What does the science tell us about CBD? Is the $600 million market a triumph of hype or a hopeful promise?”

As previously reported in the Washington Post, on June 16 the FDA released a document called “What You Need to Know (And What We’re Working to Find Out)” that states: “We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is currently illegal to market CBD this way." Last week, a bipartisan group of lawmakers introduced a bill intended to promote federally authorized research into marijuana and its derivatives like CBD.

Just as cannabis has progressed, the psychedelic movement is following suit in terms of how advocates are approaching decriminalization (then, legalization) for adult-use and as a regulated medicinal aid for mental health. And for an organization of the Aspen Institute’s distinction to acknowledge it through a curated conversation, “Is very important. It legitimizes the work we have been doing for the past 30 years,” says Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS).

Formed as a nonprofit in 1986, MAPS is “a research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana,” according to its website. Doblin prefers to refer to it as “an international psychedelic pharmaceutical company” and employs more than 50 staff members working on designing and sponsoring studies.

With a phase 3 clinical trial for MDMA-assisted psychotherapy underway and FDA approval anticipated in 2021, Doblin adds, “These days, I feel like I'm in almost a perpetual state of astonishment at the way things are going, and being asked to speak this year at the Aspen Ideas Festival is just one example of approval and how rapidly our cause is moving.”

MAPS also recently received a $900,000 annual donation commitment for the next three years from Elizabeth Koch and counts David Bronner and Joby Pritzker as members of its Board of Directors.

Doblin was one of three “Bad Drugs Are Looking Good” Aspen Ideas panelists asked to shed a light on how, “Psychedelic drugs, such as psilocybin and LSD, can trigger a schizophrenic episode, but their potential to treat addiction, control post-traumatic stress disorder, and prepare terminally ill patients for death is intriguing. Researchers are taking a fresh look at the treatment value of drugs with a reputation for danger and making some surprising discoveries.”

Many post-Aspen Ideas Festival questions obviously remain, but here are the top takeaways shared during each panel presentation (also available to watch in full online), to inspire future dialogue for both movements to move forward.
CBD: Hype or Hope?
Moderator: Matt Laslo, Freelance Reporter, Adjunct Political Communications Professor, Johns Hopkins University

Panelists: Mallory Loflin, Research Scientist and Principal Investigator, Veterans Affairs San Diego Healthcare System; Assistant Professor of Psychiatry, School of Medicine, University of California San Diego; Marcel Bonn-Miller, Global Scientific Director, Canopy Growth Corporation; Assistant Professor of Psychology, University of Pennsylvania Perelman School of Medicine; Hunter Land, Associate Director of Cannabinoid Research, Canopy Growth Corporation

On drug testing:
“We tested folks that are just taking hemp extract and they’re popping positive left and right at pretty decent quantities.” ⁠—Marcel Bonn-Miller

"That depends, right. So I think some nuance around what that means, and if you're taking a whole plant extract, full-spectrum, you will probably fail a drug test. And if you're taking something where they isolate the CBD, then you probably won't." —Hunter Land

"I think most folks don't realize that [the majority of] CBD can still contain up to .3 percent THC. And that, yes, especially if you're dosing chronically, that absolutely could lead to a positive drug test. And we have data." —Mallory Loflin

On lack of regulation:
"So not to freak everybody out ... first, there are some good people and good companies on this space. But right now, the problem is the CBD market is in everything and there is actually no regulation. So the safety of when you buy a bag of Doritos or a Hershey bar, you know that it's gone through checks and balances and has nutritional facts on it you can trust. That's not the case here.

Each state is dealing with regulating this on their own and they're kind of having to create their own mini FDA's, which is crazy. You have a lot of companies that are just cranking stuff out and some don't have as much CBD as they say they have in it." —Marcel Bonn-Miller

"I think really what we need to do is empower the consumers to say, 'Hey, we want clean products.' My recommendation is if you buy these products, get a legitimate lab certification. If [a CBD company] doesn't have it, but says, 'Oh, I promise it's fine. It's great. It's organic,' I would say that's probably inaccurate." —Hunter Land

On traditional medicine:
"One thing that kind of gives me hope for the future is an overwhelming majority of physicians really want education. I think a lot of physicians and practitioners are like, 'We don't want any recommendations without hard data to back it up,' but it means it's going to take us [researchers] a while to catch up before anything comes close to you getting a solid recommendation from your medical provider." —Mallory Loflin

On CBD vs. THC:
"When talking about dosing [PTSD subjects] with CBD, we need high doses. That's very different with THC, where we would be dosing at just a few milligrams versus hundreds. A lot of our clinical data is suggesting that it looks like really high CBD oil, and very, very low THC might actually be the ticket for anxiety. But a lot of them were going to their dispensary and picking up high THC products on their own. So there's a big mismatch between what people are using and what we're actually studying." —Mallory Loflin

"They just have very different effects. What I like to say is, 'Cannabis is not cannabis is not cannabis.' When we talk about the plant, this is something that has 120 different chemical molecules in it called cannabinoids. Beyond those cannabinoids, there are terpenes, flavonoids, all sorts of different things.

CBD and THC are just two of the 120 cannabinoids in the plant. Most of the work has been done on THC historically. CBD has really gotten the limelight within the past five years from a research perspective. And then there's the other 118 which we know almost nothing about." —Marcel Bonn-Miller
Bad Drugs Are Looking Good
Moderator: John Torres, NBC News and MSNBC Medical Correspondent
Panelists: Rick Doblin, Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies; Mallory Loflin, Research Scientist and Principal Investigator, Veterans Affairs San Diego Healthcare System, Assistant Professor of Psychiatry, School of Medicine, University of California San Diego; Dennis Charney, Anne and Joel Ehrenkranz Dean, Icahn School of Medicine at Mount Sinai, President for Academic Affairs, Mount Sinai Health System;

On ketamine:
"The first study showing that it was an antidepressant was based on the idea that a neurotransmitter was involved. To our surprise, somewhat, but not completely, we found that low doses produced a very rapid antidepressant effect in some patients within a few hours. And these were patients who had been depressed for many years." —Dennis Charney

On big pharma:
"Ketamine would be more effective when combined with psychotherapy instead of just being seen as a pharmacological intervention. But pharmaceutical companies don't understand anything about psychotherapy. And all of the drugs that we've been talking about are in the public domain. And that also limits for-profit investors from getting involved, which is why we we're doing nonprofit drug development through donation." —Rick Doblin

On drug-assisted therapy:
"It’s not about the drug. It’s about the drug-therapy combination. So if people get these [substances] on their own and they shouldn't expect the same kind of results." —Rick Doblin

On history:
“I mean, MDMA was a quietly known therapy drug from the middle of the seventies to the early eighties when it became known as the party drug, ecstasy. The sad part of this is thinking about all the unnecessary suffering that there has been when all this research was suddenly locked by the DEA. If we look at MDMA in particular, they first moved to criminalize it in 1984. That's when we had these DEA hearings, and we actually won. The judge said that MDMA should be illegal for adult-use, but it should be legal for therapeutic use. But the DEA rejected that recommendation. That was in 1986 and when I started MAPS.” —Rick Doblin

On abuse risk:
"We're really trying to mainstream them [these drugs]. There is abuse potential and that's a big concern, but we need to educate people honestly because when we do, these exaggerated harm reduction and public education campaigns that people know are not true, then they don't know what to believe and then it's even more dangerous because they'll try things that maybe they shouldn't." —Rick Doblin

"I think it's a really important point, too, that yes, these drugs aren't all bad, but they also aren't perfect like any medication. I think one of the biggest problems is that application is just so far out. Remember, the scientific understanding is that everybody's using them recreationally. So we kind of can't get that message out when we're in this phase of having a political battle around these substances as medication." —Mallory Loflin

"When you consider the issue of abuse, people pull back and they've pulled back too far, so now we've got to push it [the research] forward again." —Dennis Charney

On psilocybin decriminalization:
"The people who are doing a lot of the work with the psilocybin, particularly at Johns Hopkins and NYU, were freaked out by that. They thought that once the science was being used for drug policy reform, they were worried that the FDA would crack down, but that's not going to happen.

We [MAPS] think decriminalization is helpful because the more that the public is sort of moving in this direction, the more science will be needed. From the regulatory perspective, these efforts are helpful to us, but the thing that's unhelpful is that they make all these incredible claims and that destroys a lot of credibility." —Rick Doblin

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