Be careful what you ask for, because you just might get it. Gaining scientific legitimacy, ending stigmas, and seeking mainstream acceptance have long been goals in the psychedelic community, but now that all of these things are happening, this relatively small and close-knit community is experiencing some growing pains.
Profit and psychedelics are a tricky marriage. Set, setting, and intention are so important in shaping the psychedelic experience, and we naturally want to encourage the proper containers and intentions surrounding these powerful substances and practices. As such, we tend to be wary of for-profit endeavors, as they can potentially involve ethical compromises for those whose primary goal is profit.
Yet it is important to realize that for-profit psychedelics are already a thing. Retreat centers around the world accept money for psychedelic retreats. Underground shamans accept payment as they travel around the world providing psychedelic experiences. Psychedelics are often gifted between friends, but most of the time money is exchanged between a dealer and a buyer to procure psychedelics for underground use. What many people are wary of, I suspect, is capitalist institutions, aka the dreaded corporation. With many examples of corporate malfeasance, particularly when it comes to big pharma, people are rightly concerned about what this may mean for psychedelics going mainstream.
Much of this concern has landed on one of the rising stars of the for-profit psychedelic world, the US/UK based Compass Pathways. Compass made news recently for securing FDA breakthrough medication status for psilocybin in the treatment of depression- a major win for psilocybin research and psychedelic acceptance in general- yet their tactics over the years and their financial backers have ruffled a few feathers along the way.
To seek insight on Compass and their critics, and to address the larger debate around psychedelics and capitalism, we spoke with Rick Doblin, founder of MAPS, champion of working within the system to promote psychedelics, and perhaps the most successful and impactful psychedelic advocate in modern history.
Thanks so much for speaking with us, Rick. It’s an interesting time in the world of psychedelics. Starting with broad strokes: when you look at the current landscape of psychedelics, capitalism, and the conversation surrounding for-profit institutions, what is your take?
To start off, I think what we see with a lot of for-profit ketamine is that people are delivering ketamine without any psychotherapy; they’re looking at it as a pharmacological solution alone. I think that probably won’t be as effective as it would be if they combine it with therapy. There’s a tendency in the for-profit world with Johnson & Johnson and big pharma to just think of pharmacological solutions, and not really to think about psychedelic-assisted psychotherapy. So I think that’s one concern.
I think the other big concern that people have is with psilocybin. There is both a nonprofit and a for-profit company working to develop psilocybin: Usona Institute and Compass Pathways, respectively. I think that the main worries people have about for-profit psilocybin are being considered out of context, because there is a nonprofit psilocybin competitor that will compete in terms of what they charge, how therapy is administered, et cetera. So I feel pretty comfortable with the way things are moving forward.
Another concern people raise is about the patents that Compass will have on the production of GMP psilocybin [Good Manufacturing Process or GMP is the production quality needed for therapy and research]. People are concerned they will block Usona from getting their own GMP psilocybin, and it’s my view that the patents from Compass will not block Usona from finding their own source. I guess I would ask people to hold their criticism until six months to a year from now, when we’ll see if Usona announces that it has its own GMP psilocybin. I think they will be able to do so, but we’ll just have to wait and see.
The other concern you have with for-profit development is this sort of critique of capitalism, that it’s all about profit maximization and that it doesn’t take into account human needs- it’s all about making money. I think that’s not the case. From all that I know about Compass and what they’re trying to do, I think they have both financial and humanitarian motives.
And I guess I have one more point, which is that I think Compass is doing incredibly good work in educating mainstream psychiatrists and psychotherapists all over the world about the value of psilocybin. They recently obtained breakthrough therapy designation from the FDA for psilocybin for treatment-resistant depression, and that’s really helpful. That will help everybody in the field, including Usona. So I think we’re in a terrific situation, and the easy criticism of “Oh capitalism is bad, for-profit companies are bad and they are trying to do evil things with psychedelics to monopolize the market”- I don’t think that’s really happening. I think we all have to give each other the benefit of the doubt and just watch what people do and watch what happens. So that would be my final statement on that: let’s be cautious and be concerned, but let’s watch what happens. It’s about the people and how things are done. There have been all sorts of scandals about the Red Cross and how they run their blood banks. Even nonprofit organizations can do things that are questionable, and for-profits can do things in ways that are honorable, so I’d say just watch behavior. That’s the main thing.
The final part is that all of the information that Heffter put out- all the studies that they did, and all the studies that MAPS has done- they were designed to educate the public. We put that data and science in the public domain for anybody to use for any purpose. So there’s no sense that a for-profit is taking advantage of all this work from nonprofits. The nonprofit Heffter funded these studies to get the word out in order to inspire people to move forward in order to change the cultural climate. My sense is that we should be looking at the for-profit development of psilocybin as a sign of the success of the nonprofit work, rather than a sign of “Oh my god they are ripping off of the nonprofits!” It’s a sign that the political obstacles, the regulatory hurdles, and the public opinion problems have been addressed to some extent by all this prior nonprofit work.
MAPS is now 32 years old- we’ve been around since 1986. The idea that there could be for-profit psychedelic psychotherapy drug development only makes sense within the last year or so. For all of these years, it only made sense to do it as a nonprofit because nobody would have thought that a for-profit endeavor could ever succeed. The fact that investors are willing to take a gamble with their money is a sign of success of the nonprofit work- that we’ve cleared out enough of the political, regulatory, and public opinion problems that this can now be like a normal field of science, or at least in that direction.
I definitely agree, but this success has not come without some growing pains. Let’s jump right in and discuss some of the specific concerns raised about Compass. First up, we have the fact that you touched on earlier: Compass has secured an exclusive manufacturing deal with a company called Onyx that produces their GMP psilocybin. Some people don’t like the idea of exclusive deals, and worry that they are blocking nonprofit competitors like Usona from getting their own supply.
So here’s a background to this. Years ago, I first heard about Onyx from Shlomi Raz who started Eleusis Benefit Corporation, which is a for-profit benefit corp designed to work with LSD and other psychedelics. We looked at production companies in Canada, the United States, Netherlands, and Germany and we prepared this big report over months and months. At the time Onyx was the low bidder, but they had never made a commercial product before, so at MAPS we decided that instead of going with them, we’d go with this company now known as Sterling for our GMP MDMA. Then I shared all of that research with Usona, because they were also looking for a source of GMP psilocybin. So Usona had all the information, including all of the bids from Onyx, before Compass ever worked with them- but like us, they ended up working with Sterling.
MAPS started having a lot of problems with Sterling: they were missing deadlines, missing budgets, and it just got more and more frustrating. Eventually we decided to end the contract with Sterling and move to Onyx. That was after George Goldsmith [Chairman and co-founder of Compass] started working with Onyx. George told me that he found them to be great, so we went with Onyx to make our GMP MDMA, and we were very satisfied with them. So I told Usona “We’re leaving Sterling, I just don’t think they’re going to do it for us.” Usona kept with Sterling for another year or so after that, but eventually decided they needed to go with someone else. By then, Onyx had secured the exclusive deal with Compass.
Usona had every opportunity to go with Onyx- they were aware of Onyx, and they chose not to go with them. Compass as a for-profit company made an exclusive deal with Onyx, which is what happens all the time in the for-profit world. Usona then asked Compass if they could also work with Onyx, but Compass says no, they can only work with us, that’s part of our agreement, but if you want to license from us you can do that. That meant if Usona did any kind of Phase 3 research and they got permission to market, what they got permission to market would be stuff they’d have to buy from Compass. They decided they didn’t want to do that.
So I don’t think there is anything inappropriate about what happened in that situation. We have to recognize that the only reason Onyx made the psilocybin is because George had investors that would pay for it, and that’s what the for-profit world does. I wouldn’t hold that against them. And I’d also say that most people don’t understand the backstory.
The further backstory is that when Compass was still a nonprofit, they were trying to set up a hospice center on the Isle of Man. According to George, he approached Usona and said “Will you sell me some of the psilocybin you have for our Isle of Man project?” And Usona said no. According to George, that’s what motivated him to see that he needed his own source of psilocybin. In any case though, the issue is the exclusive contract with Onyx. That’s what for-profit companies do. I don’t think it’s inappropriate, and it’s my opinion that Usona will find any number of different ways and suppliers to make their own GMP psilocybin.
That definitely paints a very different picture of this interplay between these two companies. So the characterization of Usona as this poor nonprofit underdog being blocked by an evil for-profit corporation (a characterization made by Compass’ critics and not by Usona themselves, as far as I can tell) is not accurate?
I don’t think so, no.
Let’s move to the next item of concern. Compass started off as a nonprofit and then became a for-profit company with basically the same goals. The nonprofit to for-profit switch caught some people off guard, especially those who had helped them during their nonprofit years. There has also been mention of this mysterious intellectual property transfer from the nonprofit to the founders which has caused some to cry foul.
As for the intellectual property transfer, I’m sending you a document- take a look at the part highlighted in yellow. It talks about the transfer of the intellectual property, which I don’t think is in any way inappropriate or somehow self-enrichment.
[Rick shared with me an article for the MAPS Winter 2018 Bulletin written by Ekaterina Malievskaia, Co-founder of Compass, talking about the asset transfer. Ekaterina states: “We renamed the for-profit drug development company to COMPASS Pathways. We started the process to wind-down the non-profit shortly thereafter. The only asset that we developed that had value following the EMA [European Medicines Agency] advice to focus on the indication of treatment resistant depression was the name and the branding work we commissioned. While this was of no value to anyone else, we purchased this asset for the same amount it cost to develop. This was independently reviewed and approved by the non-profit board of trustees.”]
For the big deal made about this in the Quartz article, this seems pretty harmless. What about the for-profit switch in general?
I think they did sincerely think they were going to work in a nonprofit context. For a variety of reasons, they were unable to develop a good enough working relationship with Usona, and Usona was unable to develop a good relationship with them, so they decided to go their own way. I think that they sincerely started with the idea of doing this in a nonprofit way, and then I think they realized that they would not be able to.
Bill Linton [CEO of Usona and founder of billion-dollar biotech company Promega] is mostly funding the work of Usona. They have other donors but most of the money is coming from Bill. He’s got the resources to do that and it’s great that he’s doing that. I don’t think George thought he could raise the funds necessary in a nonprofit context to make psilocybin into a medicine. I don’t think it was a nefarious unethical plot from the very beginning.
Let’s talk about access, and the fear that Compass will price gouge or cut corners to maximize profits.
There’s this conflicting criticism of Compass that’s kind of ironic. On the one hand, people are saying they’re going to charge so much money that they’re just going to profit maximize and treatments will be super expensive and that’s going to be a problem. On the other hand, people are saying they’re going to eliminate all the therapy and make it as cheap as possible so that the most people use it, and then it will be irresponsible because it will be without as much therapy. So they are being accused of both profit maximizing with high prices, and profit maximizing by low prices. My view is that we’ll find out from their Phase 2 and Phase 3 studies, and see if they can prove safety and efficacy to the satisfaction of regulatory agencies. We want it to be available to as many people as possible, and that suggests looking at how to lower the cost.
This exercise in trying to keep costs low can be viewed as profit-seeking, but isn’t it also the best way to ensure access to the broadest spectrum of people?
Yes, you have to do that to some extent. I’ll go back to MAPS’ strategy which has been to forget about cost, and just to think about what can we do to maximize the benefits to the patients. We have overnight stays, we have two-therapist teams, we have three MDMA sessions; we’ve focused on maximizing therapeutic outcomes first. But even with MAPS as a nonprofit, the question we have to ask ourselves is: how do you make this affordable? And there’s this whole other question about equity- the fact that people who are traumatized are often those who don’t have the resources to pay for treatment. So on the one hand, we have to make sure to do everything we can to get insurance to cover it, but on the other hand, we have to really try to think out carefully what all the costs are, and how we can reduce them.
With our MDMA protocol we’re going to be making the overnight stays optional, although we do think they are very helpful. As far as the two-person therapy team goes, that’s where we’re going to get the most pushback I think, from insurance companies and others. We want to keep the two-person team, but there could be a situation where there’s one person that is a licensed therapist who’s been trained, and the other person is a student who is studying to get their license and is working for free or for very low cost. So that’s our long term plan of how to keep the two-person model but reduce the costs.
How about the fact that Compass is requiring from researchers the ability to block publication of their findings?
If there’s any research done with their psilocybin, Compass has to report all the safety information from that research to the FDA and European Medicines Agency, even if they are not conducting the studies. We have to do the same. So I think that’s a decision where they said they want to make sure that they have control of the information. Researchers can either agree, or wait and get psilocybin from Usona. So I think, again, that’s a normal behavior of for-profit companies; I don’t think it’s an evil thing per se. I would say that MAPS doesn’t do that, but we’re not a for-profit company.
Another realm of concern that’s been brought up is in how Compass is training their therapists. Allegedly there’s only a weekend of in-person training, and many of the therapists don’t have direct experience with psilocybin. What is your take on that? For a company that raised $38 million in funding, I wonder why would you only do a weekend of training, instead of doing something more extensive like MAPS has done?
I would say that Bill Richards [PhD psychologist who co-founded the psychedelic research program at Johns Hopkins University] is coordinating their training program, and if he felt that they were doing completely inadequate preparation he wouldn’t be working with them. Well I shouldn’t speak for him, but I assume as much. I think the way in which we determine whether that training is sufficient is by the results of their studies, so I think that’s what we should be looking at.
Compass has also developed a protocol where they are able to bring in therapists who want to have their own psilocybin experience. So it’s not that they don’t think that their therapists should have psilocybin; in fact, they developed a safety group therapy kind of study in which their therapists can participate. I think you might want to ask the same thing about Usona and Heffter. In all the decades of work by Heffter, they’ve never had a protocol to legally give psilocybin to their therapists, and in fact they were worried that in doing so, some people might say “Oh, you’re all biased! It’s all drug users and we can’t trust your results.”
So I don’t think that’s a fair criticism of their training protocol. We should look at the fact that right now, Usona and Heffter don’t have a protocol to give psilocybin to therapists, and Compass has developed one. When thinking about their training, whether it’s adequate or not is the real question. And we’ll only know from the results.
That makes sense. It’s interesting- as you said, the climate has shifted so much that today we say “How can you have therapists without psychedelic experience?” but even just a year or two ago, many more people would probably have said “How can you have therapists WITH psychedelic experience?”
Yes, and I think another point is that the real way that you train therapists is by having them work with patients under supervision. So that’s the last step in our therapy training program. At MAPS we have this online course, a week of watching video tapes and going through the treatment manual, independent learning that people have to do, and so on. Then we have the voluntary protocol if people want to receive MDMA, we have role playing, and then the final step of our training is they work with one person under supervision in an open label study before they work on Phase 3. So to say that the training of the therapists by Compass is only 2 days or a weekend is not right, because the training is not over. When they do their Phase 2 studies they’re going to be getting training while they are actually working with patients, and that’s really the best way therapists are trained. So there’s that additional step they are not looking at.
Thanks for clarifying that. This reaction against Compass, do you see any value in it? Is it serving as a source of accountability? Is there something positive in it?
I think that a lot of these criticisms are not being offered in a constructive way. Look at all the criticism that MAPS received for taking a million dollar pledge from Rebekah Mercer for four years for MDMA for our Phase 3 research. Rebekah Mercer and her family are one of the main funders of Trump and Steve Bannon and Breitbart. But she cares about treating veterans, and so we were willing to accept her money and build these bridges. We got a massive amount of criticism for that from a small vocal group of people, and I think that criticism is largely unfounded. I think we need to be building bridges across political divides, but I also think we need to be building bridges across for-profit and nonprofit sectors.
Compass’ real audience is the regulators. They’re going to say “Is it safe enough? Is it efficacious?” I think too much of the criticism levied against Compass is generic and anti-capitalist. It’s missing a lot of what’s actually happening, and I don’t know that I see all that much good in it. But I think discussions about this are good in general. We’re going through a cultural transformation, and the more that we think about it out loud and in a transparent public way, the better. But I don’t think the intent behind of a lot of the criticism is meant to help steer Compass.
It’s more to slash their tires.
For example, Peter Thiel invested in Compass- he was an early investor, but he’s not controlling things. I’ve seen articles claiming “Peter Thiel controls the flow of psilocybin!” [laughs] “He’s this evil guy doing all these things with Trump!” It’s guilt by association, which is not fair. Let’s have all these discussions, discussions are good. But reflexive criticism that assumes that people are acting out of the worst motives, where that’s sort of the baseline assumption being made, I don’t think that’s helpful.
Bringing psychedelics to the mainstream will necessarily involve mainstream actors, but it’s jarring for many folks now that it’s happening. So if, as you described, most of the concerns raised about Compass are unjustified, what would be some justified concerns that people could look out for if they do want to be constructive and keep a close eye? I think that beyond the conspiratorial and anarchist minority, most of the people wary of Compass are reasonable and just want to protect something that is very sacred to them from being egregiously co-opted.
My first thought is that what people could do is donate to nonprofits. You know, for-profits will do all sorts of things, but you want to have alternatives. The best check on a for-profit company is a nonprofit company doing something similar. So the most important thing people can do is donate to MAPS! [Laughs]
[Laughs] OK Rick, I think we’re done here, nothing else left to cover!
Or donate to Usona or Heffter. The real focus should be on the outcomes. What if people are are getting psilocybin for depression and it’s not helping them? What if the therapists aren’t trained enough after all, or the model doesn’t have enough therapy time, or whatever? I think that’s what we should be looking at primarily- the outcomes. Are people getting better or not, and to what extent? Are the therapists qualified or unqualified? Is there a backlash growing against the whole field because a lot of people are getting hurt? What are the side effects? The real substance will be once they start treating patients and we see how it goes. Nothing that they’ve done so far qualifies in my mind as danger signs.
But the other big thing is to say we should watch to see if Usona will get their own GMP psilocybin. That’s the key thing to look out for. If Compass has its own GMP psilocybin but Usona does too, then a lot of these fears about Usona being blocked from the field will be addressed. That’s the single most important thing going forward: will Usona be able to get its own GMP psilocybin?
In this climate they could probably make a great fundraising campaign: “Help us be the nonprofit alternative, donate now to help us!”
Well yes, that’s exactly right, but also the fact that the FDA granted breakthrough therapy for Compass, in large part based on data that was produced by Heffter, but also by Robin Carhart Harris and his team that did work with psilocybin and depression. So Usona can say ‘Help us get breakthrough therapy too.’ What Compass did will make it easier for Usona to get breakthrough therapy designation. Multiple companies can get breakthrough for the exact same thing.
As someone who has spoken in support of Compass, you are taking on some of the flak that is directed at them, and I think unfairly so. Through MAPS, which is by all measures an incredibly successful and impactful nonprofit, you hired a patent attorney to develop an anti-patent strategy to protect MDMA therapy. You’ve also created MAPS Public Benefit Corporation, which is for-profit but has to demonstrate public good. So while you aren’t afraid to voice your support for a for-profit company, your legacy of action has been built on nonprofits and public benefit.
Thank you. The way public benefit corporations work is that you put public benefit over profits, but if you have profits, they can go to investors. The different thing with us is that our for-profit benefit corp is 100% owned by the nonprofit MAPS. But you can have a for-profit benefit corp where there’s still a lot of money for private investors.
As long as they are proving reasonable public benefit from the work they are doing?
Right. You have to articulate what is your benefit and how are you delivering it.
So do you feel like the public benefit corp is one of the good answers for people who ask how psychedelics and capitalism can commingle in a beneficial, service-oriented way?
Yes. I believe we do need a new model for marketing psychedelics, and for marketing drugs in general- prescription drugs in particular. I think the benefit corporation is a really smart way to go, because I don’t think healthcare should be profit maximizing; I think it should be public benefit over profit. Profit is still a part of it: benefit corporations are for-profit, and that’s how MAPS has created its public benefit corp which is owned by MAPS. I think it’s a really great way to do it.
Author’s note: Any person who has worked with Compass and felt slighted by them, or remains concerned about their actions and tactics has every right to their opinion. We at Psychedelic Times strive to present information from a neutral, truth-seeking perspective, and we agree that for-profit actors need heightened scrutiny in the psychedelic space. However, we also believe that painting Compass’ short legacy as filled with scheming and malintent while missing their very real contributions and potential to serve thousands of people with treatment-resistant depression is one-sided and incomplete. If we can take an honest look at both the risks and the benefits of the for-profit psychedelic world and its actors without falling prey to lazy and conspiratorial critiques, we can develop nuanced understanding, informed opinions, and take constructive action to co-create the unfolding of this field in the best possible way.