TREAT California: the Manhattan Project of psychedelics
And Dr Jeannie Fontana is its Barbenheimer
This was originally published in Ecstatic Integration, a Substack devoted to psychedelic and ecstatic harm reduction, ethics, and integration.
TREAT California is a new initiative which, if successful, would create the biggest global player in the psychedelic market.
Launched this year, the initiative aims to get a proposition onto the California ballot in 2024 to create the TREAT Institute and fund it with a $5 billion state bond.
The TREAT Institute would then finance the Californian psychedelic industry from drug development to therapy, and would take equity in the companies it backs, with the goal of providing access to psychedelic therapy for all Californians.
It has already got the support of many big hitters in the world of psychedelics, like Robin Carhart-Harris, Gabor Mate and Paul Stamets.
It would be a New Deal for psychedelics, the sort of big state-funded project that built dams or developed the Atomic bomb. And the Oppenheimer (or Barbenheimer?) leading it is neuroscientist Dr Jeannie Fontana, who kindly gave me an interview.
Dr Fontana has a track record with this sort of project. 20 years ago, she was on the citizens oversight board of the California Institute for Regenerative Medicine (CIRM), which did for the Californian stem cell industry what TREAT hopes to do for psychedelics.
She was drawn to that mission because her mother had ALS, or Lou Gehrig’s disease, and she hoped stem cell treatments could treat it and other degenerative diseases. She lobbied George W Bush’s government to fund the research, but Bush and his bioethics advisor were religiously opposed to treatments that used human embryos. So instead, Dr Fontana joined CIRM to develop stem cell treatments and make them accessible to Californians.
CIRM was set up by real estate impresario Bob Klein through a state ballot vote in 2004. It was initially funded by a $3 billion state bond, with a further $5 billion bond issued in 2020. CIRM has doled out several billion dollars in grants to stem cell research projects and companies. How, I asked Dr Fontana, did she pivot to psychedelics?
‘I lost a bet’, she tells me. After working at CIRM, she, her husband and her family moved to Manhattan, where she got a job covering the health and wellness market for the Robb Report. A colleague in 2015 told her that scientists were looking into psychedelics as a new health treatment. ‘I bet him it wasn’t true, but it was’. Around that time, her marriage was also failing and ultimately she and her husband got divorced. ‘It was kind of rough for a while.’
But she was discovering a new passion in psychedelics. Initially, she says, it was purely a research interest — she read every paper she could find on the topic, and devoured Michael Pollan’s 2018 book How To Change Your Mind. During the pandemic, she had her first psychedelic experience in Mexico, where she took chocolates made by Armand Bytton, the millionaire shaman (I would not endorse going on one of his retreats, from what friends tell me).
Dr Fontana says:
They gave us these ‘heart-opener’ chocolates containing psilocybin and ayahuasca. I am a biochemist who likes to understand everything, let alone things I’m putting in my body, and they would tell me ‘let go. Don’t think about it.’ So the first ceremony, I didn’t really feel anything. I said ‘What am I doing wrong?’ And then the second night, perhaps with more in my system, I was able to go to a pretty beautiful altered state of consciousness. I felt my brain was connecting in ways it can’t normally do.
Since then, she has been on a magical mystery tour, trying MDMA, ketamine, rape (an indigenous form of tobacco), mescaline and ‘a lot of psilocybin’. She wants (she told Coleman Hughes) to try ibogaine and DMT next. Have these experiences changed her?
It’s been life-changing. It feels like the most impactful stage of my life. And I don’t know whether it’s because I’m in the sixth decade of my life and I have some hard-earned wisdom, but there’s a feeling of joy and gratitude.
Dr Fontana told Spectrum News that psychedelics gave her ‘a universal sense of love — that is the unifying force of the universe — I know it in my DNA — those who have experienced this medicine have the relationship of knowing ‘
Following these very positive experiences, Dr Fontana thought about what she could contribute to this field. And she noticed that, at the moment, no psychedelic drug has FDA approval as a mental health treatment (except for Johnson & Johnson’s ketamine spray), and many psychedelic companies and research centres are cash-starved, because the US federal government won’t change the classification of psychedelics and the National Institute of Health won’t fund psychedelic research. This seemed a similar situation to that facing stem cell research two decades earlier. Why not launch a CIRM-style initiative for psychedelics? ‘I have always worked in big projects’, she says. ‘I dream big’.
Hence, TREAT California. Dr Fontana says: ‘It will define the industry, like we did with stem cells. We were the largest funding agency, and remain so, in the world. We created the stem cell ecosystem.’
The nitty-gritty
So how exactly would TREAT work? You can read the 47-page mission document yourself, but in brief, TREAT first needs to get one million Californians to sign a petition to get on the California state ballot, and it has 180 days to do that. If it passes that goal, then in November 2024 it would put a proposition on the state ballot, and if that passed, at the end of next year the Institute would be created and funded through up to $5 billion in state bond issues.
The Institute would have a chair and seven-person board, made up of people with relevant scientific and industry experience, and this board would appoint the members of various committees, which would in turn decide which centres and companies receive TREAT grants. TREAT would fund all stages of the industry, from drug and treatment development to treatments roll-out, outcome tracking, and even public advocacy and education. It would also seek to fund itself, for example by taking equity in the companies it backs, charging licensing fees and / or taking a tax on companies’ revenues.
TREAT would also seek to gather biodata on patients to track outcomes, and one of the seven board members would be selected for their experience specifically in this area. Dr Fontana says: ‘We’re going to create the largest bioinformatics databank for mental health, by collecting all the genetic information, the brain scans, the digital information and so on’. Gathering data through apps, the TREAT team hope to be able to create targeted treatments, to find exactly the right psychedelic treatment for different genetic profiles. ‘Companies make billions of data mining, but we’re not going to do that, it will be open access. But if a company makes money off it, they will need to share revenue back to TREAT.’
In some ways, TREAT would act like a venture capital fund, but its aim would not be profit maximization, but rather, in Dr Fontana’s words, ‘the trifecta of improved patient outcomes, cost effectiveness and accessibility’.
This is a bold project, and an exciting one for an industry that is starved for cash and taking a while to get safe treatments to people (although decriminalization initiatives are rolling along at the state and city level). It’s an incredible ambition — affordable psychedelic therapies for all who want them, as well as ‘novel therapeutics’ like, say, transcranial stimulation. They should have called it California Dreamin’.
What issues might the initiative face?
But of course, psychedelic culture in 2023 is a politically-charged space. People don’t always get along or play nicely, and the TREAT initiative will no doubt face some hard challenges. For example:
1) There is already a psychedelic industry, so is TREAT necessary?
The stem cell industry didn’t exist at all before the 1980s, it was a genuinely novel technology. That’s not the case with psychedelics, which have been used for millennia. And there are already companies going down the FDA / RCT trial route — MAPS, Compass, Gilgamesh, Endeavour, GH Research, DemeRX and several others. Given that, does this market definitely need taxpayer’s money? Dr Fontana says progress has been slow:
There’s nothing! MAPS has spent 37 years with die-hard effort to raise $150 million, and it’s got one phase 3 trial of MDMA for PTSD. We’re talking about rolling this out to millions of people, safely and properly. Just because MDMA might work for certain groups of people, what about psilocybin, ibogaine, DMT and combinations thereof? What about all the other indications, and pain, and death and dying, and training therapists?
In short, the market needs to dream bigger, she suggests. With Big Pharma staying on the sidelines for now, this is a way to get the industry the billions it needs, in a manner which would hopefully make the treatments accessible to all, not just the wealthiest.
2) This sort of public / private initiative blurs public and private interests
TREAT would, at a stroke, become the biggest global player in this nascent industry. Dr Fontana says this will give TREAT the power to drive innovation and get the best price for Californians, as the NHS tries to do for British citizens in the UK. ‘He who has the money gets to make the terms’, she says.
The difference, of course, is that the NHS doesn’t also take equity in the companies it contracts, nor does it fund drug development projects. TREAT would be both investor, client, and public promoter. It would be the 800-pound gorilla in the industry, and there’s two risks from this.
The first is the risk of conflicts of interest. Accusations of cronyism have bedevilled CIRM, the stem cell institute where Dr Fontana previously worked, for the last 20 years. At one point, 90% of CIRM’s grants went to projects connected to its board members. Editorials in Nature, the LA Times and other publications bemoaned the institute’s conflicts of interest and even the Insitute of Medicine, which CIRM paid $700,000 to write a report on it, declared:
Far too many board members represent organizations that receive CIRM funding or benefit from that funding.
David E. Jensen has covered CIRM as a journalist for two decades. He has a newsletter on it, he wrote a book on it, he gave evidence on it to the state legislature. I asked him what he made of TREAT’s plan, after a look at its mission document. He told me:
The proposal borrows much from the ballot initiatives that created and refinanced CIRM, which [with interest included] will cost taxpayers at least $12 billion and more if it is refinanced some years down the road.
The proposal also is significantly different from the CIRM initiatives, particularly in allowing the proposed agency to hold stock. California’s constitution has long barred the state from holding stock in private companies. The provision dates back to the days when the robber barons of the railroad industry were deemed to have fundamental control of state government.
The proposal would create a new and potentially vast state department that would have little normal governmental oversight. It appears that the new enterprise could engage in the creation of these new treatments, and manufacture and distribute them, based on my initial quick reading of the proposal. That is likely a first-ever moment for the state.
Jensen worries that TREAT would be even less transparent than CIRM, and notes that: ‘Both the stem cell and the psychedelic initiatives involve ballot-box budgeting, which has created and continues to create problems for state government. Locking up funds through ballot measures limits the ability of the legislature and the governor to respond to the changing needs of the state.’
Dr Fontana says she has learned the lessons of CIRM, which had a bloated 35-person board. TREAT’s board will be smaller, and no one on the board will come from the nascent psychedelic industry, she tells me. Who will they be, then? ‘Senior statemen. I get to pick the cream of the crop, they run huge companies, huge programmes, huge divisions.’ (You can dive into the detail of how the board is selected and what backgrounds they would have in the founding document, page 17).
But then another risk is the board don’t have any expertise in psychedelics and don’t back the best initiatives. This would be by-far the biggest player in the industry, and the sheer size of TREAT could hamper competition and lead to ineffective allocation of capital. ‘A rising tide raises all boats’, Robin Carhart-Harris suggested to me in defence of TREAT. But some boats would rise higher than others and TREAT would be picking the winners. Who’s to say they will pick the best companies or treatments?
3) What about decrim / indigenous use?
Again, stem cells are not like psychedelics, in that they haven’t been used for thousands of years, and there wasn’t a stem cell underground subculture, populated by various groups who are 100% sure that their way of taking drugs is the One True Way and everyone else’s is heresy. In California, one finds indigenous groups denouncing Decriminalize Nature who denounce New Approach who denounce Compass Pathways and so on. Universal cosmic love? Psychedelic culture is more like a Wild West saloon.
Dr Fontana says: ‘The psychedelic community, understandably, is incredibly territorial and opinionated. And I get it because they’ve been fighting so hard to survive and they’re passionate, and I respect it, and I honor it. But there’s another big huge world out there.’ What position does TREAT take in relation to decrim initiatives or indigenous groups? Dr Fontana tells me:
We are not a decrim or legalization bill. There are several reasons we don’t support that path, the least of which is I want to make these treatments available to all Americans, not state by state. And importantly, with decrim we can’t study it. We start with the medical model, but we have research dollars to study other models. If we get a bunch of patients who have already been exposed to a bunch of medicines it raises challenges. And lastly, these medicines need to be taken with much more respect. There’s a lot of people with different emotional histories and it can be very destabilizing.
She insists TREAT’s proposed profit model of getting money from corporate partners’ IP would not stand in the way of other communities’ usage of psychedelics. If one of their companies did ‘go rogue’ and act in a predatory way, she says there could be a ‘death clause’ where TREAT could ‘have a bunch of open meetings where all stakeholders come, they give their opinions, we seek the opinions and we come up with something’. This is not yet outlined in the founding document.
4) Is the FDA-RCT approach appropriate for psychedelics?
My colleague Joseph Holcomb Adams, who worked on Berkeley’s decriminalization bill, suggests that TREAT California is very committed to the classic biotech approach — find new drugs and get them FDA approved through randomized controlled trials. But, he suggests, what if this isn’t the right route for psychedelics?
The FDA was set up via President Nixon’s 1971 Controlled Substances Act, to assess drugs’ efficacy for specific health problems, independent of context. It was not set up to assess a context-amplifier like psychedelics, the effect of which depend on the set and setting of the person and the sort of support they receive. It’s hard enough to assess individualized psychedelic therapy through a FDA-approved randomised controlled trial, let alone something like a group ayahuasca ritual.
Corporates and academics are doing their best to jump through the FDA hoop by turning psychedelics into magic pills for specific treatments, with ‘psychological support’ rather than therapy. Maybe we should just admit it’s not a good fit. After all, humans have used psychedelics for thousands of years before the FDA existed. Why try to contort the former to adapt to this transient and flawed bureaucratic institution? ‘Because it exists’, I imagine would be the biotech response, ‘and if you want to get legal treatments to people safely, funded by insurance, you have to go through the FDA route’. Joseph Holcomb Adams suggests a better use of state money would be to study naturalistic and community usage (which is how people actually take psychedelics and probably always will) and learn how best to reduce harm in that space. But that wouldn’t make biotech companies any money.
5) Can we definitely ‘fix mental health’?
A final issue which I think TREAT may face is over-promising of magic cures. Its slogan, after all, is ‘Let’s fix mental healthcare’. CIRM, the stem cell institute, was lobbied for in 2004 with similar promises of miracle cures to help Californians recover from degenerative diseases like Parkinson’s. Here’s one of its campaign adverts, which as you can see seemed to promise the rapid arrival of ‘new cures for diseases’.
David E Jensen says: ‘Nineteen years ago voters were led to believe that miraculous stem cell cures were right around the corner. CIRM has yet to finance a stem cell treatment that is available to the general public’. However, CIRM has boosted the stem cell industry and created thousands of jobs, and most expect that life-saving treatments will eventually come from its research. Nonetheless, some journalists have suggested CIRM didn’t fulfil its promises, and a few even called for the defunding of the institute. Others suggested the hype over miracle cures was as much the fault of the media as CIRM. Media ethicist Sally Lehrman wrote in the LA Times:
It’s no surprise that the initiative’s proponents made big promises: They had something to sell. But instant miracles are uncommon in science, and journalists should do a better job making that clear….By falling prey to researchers’ natural enthusiasm and fixating on near-magical potential breakthroughs, journalists set us up for disappointment
TREAT hopes to raise $30 million for its campaign, and if its successful some of its $5 billion will be used for public education. These campaigns will — like the CIRM campaigns — create public hope and demand for miracle psychedelic cures…and some people will be disappointed, and others will get harmed. Because unlike stem cell treatments, psychedelics are already available, right here, delivered to your door, any time you open Instagram or Tik-Tok. People who are desperately unwell are not going to wait years for FDA approval. You tell them this works, they’re going to go out and try it.
California dreamin’
These are the concerns I have. But I am an old, weary, exhausted European, from the UK, where we can’t even build a train link let alone a space shuttle. I always admire California for its big dreams — imagine the future, then move fast and break things to get there. In Europe we imagine the past and, like the Red Queen, run on the spot to try and stay in the same place.
California is the home of Effective Accelerationists and transhumanists like Timothy Leary or Elon Musk, dreaming of sun-kissed Californians evolving into intergalactic and immortal superhumans through AI, psychedelics and genetic technology. And there is, in fact, a hint of that in Dr Fontana’s thinking.
She co-authored a 2021 paper called ‘The Evolution of Life Forms On Our Planet’ and was published in 2021 in the Journal of Modern Physics. Its authors are Dr Robert M.L Baker, his wife Bonnie Sue Baker, and Dr Jeannie Fontana.
The paper predicts a future in which humans will evolve into saucer-eyed ravers before finally becoming spherical cyborgs rotating around planets. These are images from the paper:
Dr Baker was the first PhD in space navigation in the 1970s:
His wife Bonnie Sue worked in real estate and was quite a stunner:
Together, they were Barbenheimer (OK, last time I make that joke).
He worked on gravitational waves and space travel. One time, Bonnie Sue stood too close to the launch site.
In the 2021 paper, the authors unfurl their vision for humanity’s evolution. They suggest that, thanks to all sorts of novel therapeutics like trans-cranial stimulation and genetic modification, humans will evolve into immortal cyborgs:
As I explored in previous research, there can be a slightly Social Darwinian / eugenic tone to Californian transhumanism. There’s a whiff of that in this paper, with the mention of ‘stringent birth control’. Later, the authors talk of an ‘elite Survivors Club’ of the highly evolved:
To be charitable I would suggest this is more Dr Baker’s vision than Dr Fontana’s — she does after all talk of a universal source of love and aims to make psychedelics available to all. I asked Dr Fontana if she thought psychedelics could play a role in human evolution, but she said there’s no evidence for that.
The paper also features this imagining of a kinky robot maid at the Bakers’ Palm Springs home.
Eventually, the paper suggests, humans will evolve into spheres orbiting planets, like the Mekon from Dan Dare.
Now, some people outside the Golden State may think WTF. But this is California, dream big or go home! Honestly, I have reached the age where a part of me just enjoys the weirdness.
Good luck TREAT! The next year of campaigning should be fascinating.
If you’re interested to learn more on California and evolutionary spirituality, check out my journal article More Evolved Than You: on evolutionary spirituality as a cultural frame for psychedelics. In that, I touch a bit on how transhumanism has interacted with psychedelic culture in California, from Leary’s work in the 1970s up to present-day figures like Elon Musk, Peter Thiel and Sam Altman. More on that in this piece on Timothy Leary’s psychedelic eugenics, and this piece on Californian transhumanism.
