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Dan Gorenstein: A wave of new research is showing the promise of psychedelics to help with mental health conditions, like depression and post traumatic stress disorder.

But the federal government continues to say it’s illegal to use these substances for treatment.

However, states are increasingly taking steps to expand access.

Today, the fine line that states walk attempting to regulate the use of psychedelics.

From the studio at the Leonard Davis Institute at the University of Pennsylvania, I’m Dan Gorenstein. This is Tradeoffs.

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DG: The word psychedelics invokes a scene from the 1960s. Hippies in rainbow tie dye. Beatles music and anti-war protests.

Beatles music

DG: In those same years researchers tested psychedelics for treatment of addiction, depression and trauma.

The CIA explored LSD as a mind control drug. And Harvard professors studied if these drugs could offer a religious experience.

This came to a halt by 1971 when President Richard Nixon declared a war on drugs.

Nixon News Clip: America’s public enemy number one in the US is drug abuse. In order to fight and defeat this enemy, it is necessary to wage a new all out offensive.

Decades later research is once again in full swing. And now states and cities are revisiting whether these drugs should even be illegal.

Joining us to talk about the state of psychedelics and the law is Mason Marks. He’s leading the Project on Psychedelics Law and Regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School.

DG: Thanks for being here, Mason. Now there have been headlines about new research on potential medical uses for psychedelics both psilocybin or mushrooms. And MDMA or ecstacy.

Can you catch us up, Mason. What’s the update on emerging evidence about psilocybin as a medical treatment?

Mason Marks: The evidence is strongest for treatment resistant depression. I mean, that’s the indication that we have the most data on… Right now there’s a company called Compass Pathways…started phase three clinical trials of psilocybin for the treatment of treatment resistant of depression.

So they’re sort of on the cusp of potentially being approved for marketing their psilocybin formulation as a treatment…and they’re estimated to possibly receive that approval in the next few years. So perhaps by 2027 or so.

DG: Mason I just want to pause real quick to say indigenous communities, notably in Mexico, have used mushrooms for generations for spiritual and healing purposes.

Here in the US you said the current scientific evidence is strongest for treatment resistant depression. Are researchers formally studying mushrooms to treat any other condition?

MM: There are some other really exciting indications like there are trials just starting now for smoking cessation. And you can talk to people who have used psilocybin and other psychedelics for treating substance use conditions….It’s striking to read their narrative descriptions or talk to them.

People will tell you that they just have lost the impulse to smoke or to use cocaine or to drink alcohol. End of life care for end of life anxiety and depression is a really promising use…Things aren’t as far along in the research pathway as they are for treatment resistant depression.

DG: And what about the clinical research on MDMA, or what sometimes is called ecstacy which is being studied to treat post-traumatic stress disorder? What’s the kind of like the quick thumbnail on the medical evidence now?

MM: That’s much farther along in the development pipeline. Those trials are being sponsored by MAPS, the Multidisciplinary Association for Psychedelic Studies.

And they’ve now completed two phase three clinical trials. So they are prepared to submit that data now to the FDA through what’s called a new drug application. And they anticipate receiving approval as early as next year.

DG: And are there other indications? Are there other tests in the field right now that MDMA could potentially treat beyond PTSD?

MM: That’s a really good question. I don’t often hear about other potential uses, perhaps uses in things like family therapy or relationship issues. There’s great potential there for couples therapy, but you don’t typically hear about this wide variety of uses the way you do with psilocybin.

DG: Ok so that’s the science. Mason, you’re a lawyer, let’s talk about the law now. At least a dozen cities and states have decriminalized carrying or using small amounts of the mushrooms.

Meaning police are less likely to arrest people for possession and if there are any penalties, they are lower than they have been historically.

Mason before we get into specifics, why are cities and states even doing this, decriminalizing psychedelics?

MM: I think a lot of these cities and states are realizing that and they’re saying, look, you know, FDA approval is on the horizon, but that doesn’t mean we should be criminalizing the use of these substances in the meantime. And there’s a widespread realization that the scheduling of these substances in the first place in the in the 1970s was misguided and that they just don’t belong in in that category.

DG: What you’re saying there, is that the DEA – the Drug Enforcement Administration, continues to list psychedelics as dangerous drugs with no medical use. Just like heroin.

But Mason, it seems like at least some people think there’s a real medical use here. Right?

MM: People also realize that we have a severe mental health crisis in the country. A substance use crisis, suicide overdose. You know, unfortunately, a long list of of public health problems that many people believe psychedelics can potentially help. You know, they they actually are believed to have anti-addictive properties that help people to overcome substance use.

DG: Yea the science on that is evolving as we speak. But outside of current FDA clinical trials, as we’ve already said, it’s illegal to get psychedelics for these conditions.

So to have a state legalizing mushrooms to help with these mental health issues obviously is really tricky terrain. Oregon is the first state to try it. Voters passed the Psilocybin Services Act in 2020.

Mason, what about the law is going well?

MM: I think there are good things about the Oregon program, one of them being… Legally, it’s not it’s not a medical program. It prohibits facilitators from making medical claims. They cannot diagnose or treat health conditions.

DG: Right. Oregon put in place all these rules for how mushrooms are made, tested and even consumed.

And as you point out Mason, the state is careful to separate these psychedelic experiences from health care. So help me understand what the law actually allows?

MM: It’s effectively supervised recreational use, and a lot of people don’t like that term, but that’s really what it is…And, you know, it’s it’s it’s a funny comparison to make. It’s not that different from buying alcohol at a bar because you can’t buy the alcohol and take it home from a bar. You know, you’re kind of you have to stay there while you consume it. And if you were to leave, the bartender could be held liable for potential harm that you do.

DG: Here’s how Oregon’s system works. Adults 21 and older can come into what the state calls a service center to use mushrooms without a referral or prescription.

They sign a form saying they understand it’s not medical treatment. And the facilitators overseeing the session are barred from describing themselves as medical providers.

And yet, some of these businesses use words like therapy and healing to describe these psychedelic services.

After the break we dive into the danger of states flirting too closely with medicine.

MIDROLL

DG: We’re back with Mason Marks. He’s leading the project on psychedelics, law and regulation at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School.

Before the break he talked about the move to decriminalize and even legalize psychedelics as the scientific research is emerging.

So, Mason, Oregon has come up with this system to allow adults to use psilocybin or mushrooms recreationally.

Is this experiment a success or failure?

MM: In many ways I think it is is failing. Um, and one of the concerns is that. It’s legally not. A form of health care…but many service centers are portraying it that way. They will advertise on their website that they will treat your addiction or provide you with psilocybin therapy. And the reason I think that’s concerning is that we already have a medical pathway that is developing FDA approved psychedelics. And I’ve heard from many operators in Oregon that many people who come to them as clients, they are intending to treat a mental health condition.

DG: Ok, one of the goals was to make psilocybin use safe, affordable and accessible. Is it working as intended?

MM: It’s still very early to tell how the system is working. There have been some real challenges, though. A lot of companies that had announced that they would be coming to Oregon have either canceled their plans or they’ve closed their doors after actually opening for business. I think what people are finding is that this is a very expensive proposition to open a service center…Another is just affordability. It’s the the cost to clients has been very high, I’d say, in the range of $1,800 to $3,000 for a single round of psilocybin services.

DG: There are a couple of reasons behind the high cost. First, the program was created to be self-sustaining with much of the revenue coming from licensing fees, which can run about $10,000 bucks a year.

Layer on top of that money to run a center and pay your workforce, state licensed facilitators. That’s a lot of overhead.

DG: Two years after Oregon legalized psilocybin the state of Colorado followed. Now, Colorado is developing rules for its program that’s set to kick off in 2024.

Mason, the Rocky Mountain state seems to be iterating on Oregon’s approach of these expensive service centers. And going even further, Colorado is considering whether to allow facilitators to administer mushrooms in peoples homes.

What do you think about that?

MM: That is something that the Colorado Natural Medicine Advisory Board is is debating right now.  I think I personally and many others saw Colorado added the potential for home administration…And there are some people that are very, very skeptical, very concerned of home administration. They really want to tightly control every aspect of this program…. So I don’t know how that’s going to shake out.

DG: Mason it’s clear Colorado is flirting with a more medical approach. To the point where they call their facilities healing centers blurring the lines between psychedelics and medical practice.

But this brings me back to this federal state tension. Is Colorado headed for a legal showdown with the feds?

MM: I think if you’re making medical claims, you are out ahead of the science and it has potential legal implications for everyone involved…So that’s problematic from a legal perspective because then arguably the FDA might have to step in if and other agencies potentially as well that deal with advertising like the Federal Trade Commission, they they worry about things like misleading consumers. And so if you have companies out there that are framing something as a medical therapy when it’s not. I think that draws a lot of of heat from the federal government. So the FDA, it’s very common for the agency to issue cease and desist letters to cannabis companies, CBD companies…for making medical claims about their products. And the same would potentially apply to psilocybin manufacturers or service centers.

DG: So Mason, you know other states like California, Washington and New Jersey are also thinking about legalizing psychedelics.

What are those states watching for in Colorado and Oregon?

MM: I’m not sure exactly what they’re what they’re watching for. The states you mentioned are kind of on the brink of potentially taking taking the next leap into this this experiment…I think it could be a mistake to be forging ahead in other states without really analyzing that, without really deeply thinking about it and trying to learn from some of the the lessons from Oregon.

DG: Thanks, Mason. Final question here. We have to kind of like talk about the 800 pound gorilla, right? Like, Big Pharma wants in on this psychedelic craze, too. You’ve got a British pharmaceutical company called Compass Pathways that has patented a formulation of psilocybin that is used in research. As you watch these states sort of experiment. What do you see as the benefits and the downside of Big Pharma getting into this?

MM: Yeah, well, the benefit is you need them to run the trials. I mean, FDA sanctioned clinical trials are important. They’re very expensive and labor intensive. It takes a long time. So you need them involved to do that work.

I think the drawbacks are when…they overstep through the patent system. What is ethical to claim an intellectual property interest in. You know, when there is truly novel innovation that deserves patent protection? I have no issue with that. I think many people would agree, but there are many cases where people have attempted to patent things that really are not new in this space. And there’s a real grab for intellectual property to mark out one’s territory. And that’s when things become a bit a bit concerning.

DG: I really appreciate you taking the time to talk with us on trade offs. Mason Thank you very much.

MM: I really appreciate the opportunity to chat with you.

DG: I’m Dan Gorenstein, This is Tradeoffs.