D-Day for the psychedelic industry?

You can watch today's FDA advisory hearing online at the link below

Today is a big moment in the history of the psychedelic renaissance – an FDA advisory committee will hold a public meeting and then vote on whether to recommend MDMA-assisted therapy in an FDA application bought by MAPS / Lykos. The FDA will then decide in August whether to approve the application - it doesn’t have to follow the advisory committee’s advice but apparently it does 80% of the time.

You can watch the advisory hearing yourself online, here, and see this historical moment play out – it starts at 8.30am EST and runs all day.

A year ago, the psychedelic industry and culture thought MDMA approval was a done deal. ‘The evidence is too strong to ignore’ one MAPS therapist told me. A colleague who covers the industry better than anyone else told me they thought it was 85% likely to happen. MAPS people seemed to think it was 100% likely. Its Psychedelic Science jamboree in June 2023 seemed like a victory lap.   

I wondered if the industry was over-confident.

Since then, the Institute for Clinical and Economic Review has published quite a damning report saying the evidence for MDMA therapy’s effectiveness is still unclear.

And the FDA itself, last week, appeared to criticize MAPS for not collecting data on whether participants felt ‘euphoria’ on the drug, thereby raising its abuse potential – some observers think this might be the FDA giving itself an excuse for not approving the drug, as they can say MAPS / Lykos didn’t follow the agreed protocol by not collecting this data.

Critics and supporters are lining up their arguments for today’s hearing. On the one hand, there are psychonauts who have been working for 40 years to legalize these drugs and bring them overground, and now they’re being attacked…by other psychonauts! There are also people with PTSD, desperate for any new treatment, some of whom have been healed by MDMA and are indignant that this healing might not become widely available.  

On the other hand, critics are quite right that there are serious issues in the field – psychedelics make people suggestible, they make people prone to religious enthusiasm and cult-like thinking, and in perhaps 10% of cases they can lead to difficulties on the trip and afterwards too. And there is a glaring lack of research and support for those who experience these difficulties.

It still seems to me more likely than not the FDA will approve the application. Why? Three reasons:

1)        Psychiatry is desperate for new treatments to deal with rising rates of mental illness.

2)        There is political pressure from Veteran Affairs, which apparently is gearing up already to roll the treatment out for traumatized veterans

3)        FDA approved Spravato, Johnson and Johnson’s ketamine nasal spray, which had just as many safety issues as MDMA if not more and the FDA, under political pressure from president Trump, approved it. However, we should note that the Spravato application didn’t include a therapy component, which complicates matters as the FDA isn’t used to assessing or approving psychotherapies.  

But what if the FDA doesn’t approve MAPS / Lykos’ MDMA therapy application?

Other more traditional biotech companies will press on and likely succeed where Lykos didn’t, like Compass, Cybin, GH Research, Gilgamesh and so on. Nonetheless it will be a blow to the credibility of the field – the flag-bearer for psychedelic medicalization for the last 40 years failed at the final hurdle. It would likely lead to a further cooling of investment interest in psychedelics.

Ironically, I think it would make it more likely that psychedelic companies minimize the therapy component of their applications (they’re already doing that). In that sense, one could argue the failure of MAPS’ application would make psychedelic medicine less safe.

Meanwhile, the failure of MAPS’ decades-long attempt to bring psychedelics into the overground would certainly be a boon for the decriminalization movement, for the underground, and for psychedelic retreats abroad – at least in the short term. In the long-term, it might mark the peak of a wave of mainstream public interest in these substances, and their return to the fringes of alternative health and spirituality.

I’m off to Europe’s biggest psychedelic science conference today, and I am sure a no vote in today’s advisory committee would cast a shadow over this week’s proceedings.

What do I want to happen or think should happen? I supported calls for today’s public hearing, because there is good evidence that not all adverse events were properly tracked and disclosed in MAPS trials (see Olivia Goldhill’s recent article for example). By the way, not to single out MAPS, this is true of many other psychedelic trials as well, by the way, and many non-psychedelic drug trials as well.

In fact, according to FDA advisory committee member Suzanne Robotti,

33% of drugs approved by the FDA between 2001 and 2010 were later found to have significant safety issues, where the drugs’ labels had to be modified with a “black box” warning, withdrawn from the market, or, at minimum, manufacturers had to send a letter out to all prescribers. It took an average of about 4.2 years to discover those issues.

I believe drug companies (psychedelic or not) should be held to account and pressured to be as transparent as possible on adverse effects, so consumers have the best information to make decisions.

Meanwhile, the central and over-riding aim of this newsletter is to help people and western culture in general integrate ecstatic experiences wisely, ethically and relatively safely – that includes the integration of psychedelic practices, which are the easiest route to ecstatic experiences but not the safest.

The psychedelic renaissance has led to much wider cultural familiarity with and acceptance of altered states. In that sense, I am excited by it. 12 years ago, when I started researching ecstatic experiences, it was an incredibly niche, marginalized and disregarded topic, now it’s a very accepted one and you can get funding to research it and work with altered states. That’s amazing. I believe my culture should be more open to transcendent experiences.

But I’m also worried by how gung-ho psychedelic culture and industry can be, how little some in the industry seems to care about safety, and how many undertrained, over-confident and (sometimes) irresponsible operators have flooded into the boom market, certain they have the skillsets to work with these powerful substances.

And I’m concerned about the lack of support for those who get into post-psychedelic difficulties. Don’t send people into outer space if you don’t know how to bring them home.

Well, let’s see what happens today. Whatever happens, we’ll keep focused on our mission of psychedelic and ecstatic integration, trying to help western culture integrate ecstatic experiences and practices ethically, wisely, and as safely as possible, while appreciating that ecstatic experiences are never entirely safe or predictable.

After the paywall, this week’s links, including can psychedelics change your genes, how cannabis legalization messed up in Canada, is life coaching a pyramid scheme, the DMT artist who made a fortune out of NFTs, plus videos of two seminars I took part in, one on the problems with evolutionary spirituality, and another on psychedelics and cultic social dynamics with Dr Steve Hassan, and a new psychedelic therapy course I’m teaching on.