MAPS / Lykos: who is to blame and what happens next?

Ways forward for the psychedelic renaissance

On Tuesday, the FDA advisory panel voted against supporting Maps / Lykos’ application for MDMA-assisted therapy for PTSD. They voted 9-2 against the statement that (according to Lykos evidence) MDMA therapy is effective, and 10 to 1 against the statement that the benefits outweigh the risks. It was brutal.

One person at MAPS put a brave face on it. ‘It could have been worse…it could have been unanimous!’

No one expected it. Not even the critics who led the charge against the application expected they might actually succeed. Neşe Devenot, a senior lecturer at Johns Hopkins University who is a leading figure in the public criticism against it, wrote:

I thought that we would just be putting a warning on the official record, so that people who got hurt later could access resources for validation and justice. I thought the momentum behind MDMA could not be overcome by a small group of independent scholars, activists, and former trial participants. But yesterday, beyond my wildest expectations, we made international news in a David and Goliath-scale, "dark horse" victory that contributed to the FDA's Advisory Committee voting "no confidence" on Lykos' application.

NB, whatever you think of Neşe and her colleagues’ take on MAPS, they were brave to take a stand, and their criticisms are not the principal reason the ad-comm board rejected the application. Blaming them is an easy cop-out for the field.

It’s not clear what the knock-on impacts might be on the entire field. Nicolas Langlitz, a psychedelic anthropologist, says: ‘One hypothesis is - if Lykos’ MDMA application fails then the psychedelic renaissance is over.’

It reminds me of Brexit somehow – did we accidentally just leave the EU?

I felt in some minor way responsible, in that I was one of the people who supported the petition to extend the public hearing by 30 minutes, and am in favour of full disclosure and discussion of any adverse events or misconduct. Still, the data is so good, MDMA therapy must help more than it harms, right? The question is, how reliable is the data, and how will this look when it’s rolled out by Lykos at scale. Even before then, imagine how many opportunists would immediately spring up on Instagram offering ‘FDA-approved MDMA therapy’ – medicalization lends legitimacy to underground grifters.

I’m here in Holland for ICPR, one of the big psychedelic conferences, where there’s an air of shock, concern and even depression about the outcome. There’s a lot of the discussion off stage about what happened, who’s to blame, and how it will affect the field.

It doesn’t mean the game is over globally. Just this week, a Dutch commission recommended MDMA-assisted therapy be made legal, the Dutch minister of health opened the conference with an encouraging speech, and the EU is now spending millions of euros supporting psychedelic trials. It’s not over yet for Lykos either. This was an advisory vote, the FDA itself decides in August, and insiders feel ‘they really want to get this done’.

Rick Doblin, ever the optimist, told the conference there is ‘substantially more than a 50/50 chance the application will be approved in August’. He also suggested the FDA plans to abolish advisory committee voting, which is one way to handle a bad result.

So what went wrong, who is to blame and what is likely to happen next?

There has been tension between MAPS / Doblin and Lykos for a while, and there are signs of more tension between the two following the advisory committee vote outcome.

Doblin founded MAPS in 1984 as an NGO with two missions – medicalization of psychedelics (especially MDMA-Assisted Therapy) and drug policy reform so anyone who wants to take drugs can. It raised $150 million in funding from US philanthropists, many of whom were very into psychedelic spirituality themselves and enjoyed taking them at Burning Man and hanging out with Rick.

Then came the shroom boom in 2020. Psychedelic biotech companies started appearing, led by German biotech investor Christian Angermayer, who founded an investment firm called atai and also invested in a psilocybin company called Compass Pathways. Angermayer and other psychedelic biotech founders have raised $4 billion in funding on the stock market. Suddenly that meant MAPS philanthropists were less keen to give philanthropic donations – they could invest in psychedelic companies instead. ‘We were a victim of our own success’ says Doblin.

Best of frenemies - Angermayer (left) and Doblin at 2023 Psychedelic Science

To raise funding for its MDMA application and roll out, MAPS needed to launch a more traditional biotech firm, Lykos, which raised $100 million through shareholders last year. MAPS has a minority stake in Lykos. Doblin says the need to launch a for-profit biotech ‘was the biggest failure of my professional life.’

Doblin is not at the driving wheel anymore. Lykos brought in biotech managers and investors, some of them are not from the psychedelic community (gasp!) and they’re not necessarily on board with MAPS’ mission of drugs for all and the spiritualization of humanity.

So there is a tension between MAPS’ Burning Man culture and Lykos’ buttoned-down biotech culture, between mission one of drug reform advocacy and mission two of getting MDMA therapy FDA-approved.  There is also a difference of approach – Lykos managers and investors think: ‘just focus on the data’, MAPS’ mission is ‘change the culture’.

Over the last few months, Lykos has no doubt been telling Doblin to keep quiet to align with FDA rules, while MAPS, Lykos and Doblin personally have been taking a pummelling in the media.

Lykos also for some reason didn’t engage with the Institute of Clinical and Economic Review (ICER) when it prepared a very damning report on Lykos’ MDMA treatment, in which it decided the evidence was unclear as to its efficacy, because of methodological issues, poor reporting, and the quasi-religious enthusiasm of the researchers and some of the participants for psychedelics.

It was in retrospect a big mistake for Lykos not to engage with ICER. One veteran of the field who has supported MAPS for many years says: ‘We didn’t see it coming. The feeling was Lykos just needed to engage with the FDA.’

Such a damning report from ICER – a respected organisation outside the psychedelic bubble – suddenly cast doubt on whether Lykos’ application would succeed and could have affected the thinking of the FDA advisory committee. Which brings us to Tuesday’s ‘disaster’, as Christian Angermayer called it.