The Right to Try
It started with a meeting with a young woman.
Her toddler son suffered from a debilitating genetic disorder called Duchenne muscular dystrophy. While extremely rare (about 1 in 4,000 boys), the median life expectancy was around 30 years. A significant improvement from earlier cohorts.
But a promising therapy was in clinical trials.
Then a meeting with a nonprofit lobbyist. And some state legislators.
They all wanted a federal law that changed access to experimental therapies, ones still being tested but not yet meeting the FDA’s threshold for safety and effectiveness.
States had begun passing a version of laws in this direction, but without a federal statute it was unclear to what effect.
They referred to these as “Right to Try” (RTT) laws.
These meetings were through my job at a Senate committee normally having little to do with healthcare. But “he’s elected, I’m selected” as we would say. My boss was the committee Chairman and decided this needed doing.
A detour through Congress
The short version of how Congress is organized:
Every member has a “personal office” staff, physically working next to the boss’s primary office. Among other things they are the frontline in constituent services, often having regional offices in their district or state. Typically they have the most day-to-day interaction, are responsible for analyzing every forthcoming vote and making recommendations, developing their own legislation, and overseeing the entire portfolio of issues the boss is interested in.
The members are also assigned to multiple committees. These are each specialized in a narrower set of issues. All legislation is initially referred to one of these committees, and the committee’s job is to work through them. Each committee has its own staff. If you’re the committee’s Chair or Ranking Member the staff works explicitly for you (they decide payrolls and such).
As a committee staffer, I focused on a general set of issues — it inevitably grows as you stick around — but the Chairman is ultimately who is in charge.
So if they task you with something outside your portfolio, that’s the job.
The Debate
Advocates for Right to Try wanted to permit patients with the most severe conditions to be able to receive experimental treatments, medicines which have not received approval, without jeopardizing potential FDA approval. The companies developing new therapies could provide them to the most sick people and still continue investigating with intent to sell to the broader medical market.1
A law eventually emerged through negotiations, first with another Senate committee, then with the then highest-funded trade association (PhRMA), and then with the House counterpart committee—though that’s redundant, because the last two were functionally the same thing.2,3
But it didn’t include experimental substances prohibited by the DEA. Like psychedelic therapies. Exempting controlled substances was a negotiating concession but I would’ve been fine with it (even preferred).
On the way to becoming a law, the bill was name-checked during multiple State of the Union addresses, and afterwards during the infamous Biden v. Trump presidential debate.
But not everyone was supportive.
Pharmaceutical companies, while not opposed per se, appreciated the ability to point to the FDA as the reason they couldn’t provide pre-approved therapies to patients. The FDA enjoyed being able to say the reverse, that it’s not up to them.
But the most vocal opposition was a couple bioethicists, in particular eminent scholars Art Caplan and Alison Bateman-House, NYU faculty and members of the Working Group on Compassionate Use.
Pick a Lane
Eliding the actually defensible counterargument to our own advocacy, the frustration came down to this. At various times these two and sympathetic trade press would argue one or more of the following without acknowledging the internal logical inconsistency:
this manner of access would expose large numbers of sick patients to undue risks
no company would want to provide access under this law
it provided false hope to desperate patients
If you can’t see the contradiction therein, then, well, maybe I’m the problem. A thing is poised to impose likely harm on scores of individuals, but also will be mostly abstained by drug developers? And the third, this may be bioethics inside baseball, but “false hope” is subjective. Our PO: if your doctor is saying you’re facing almost certain death in months, what’s the disutility of hope, false or otherwise?
Paternalistic, chauvinistic, and un-self-aware of their own obtuseness. I begged one of the major trade pubs regularly running their op-eds to host a debate, or at least a written counterpoint to no avail.4
Anyway, we won and passed the law.
Unclear if: (a) scores of patients have been harmed as a result; (b) zero patients have been subject to the law or (c) drug development has been materially jeopardized as a result (oh yah, forgot to mention, that was another confidently stated outcome).
[Later I would find out, when I was 14 and my mother died of breast cancer, her doctor identified but could not administer a then-experimental treatment that had since become standard-of-care]
The Psychonauts Come Knocking
A couple years later, parties interested in the potential therapeutic benefits of psychedelic drugs saw RTT as a pathway to expand legal investigation and use. There has of course been a spate of interest in developing psychedelics for medicinal use across all modalities, and RTT was of particular interest as a pathway. A 9th Circuit court case subjected the law for use along these lines.
So it turned out my work with RTT was inadvertently a psychedelic experience.5
Whatcha Know About Weed?
On my first day at the White House in a role overseeing federal regulations, the USDA was in the midst of establishing a federal regime for a subset of cannabis now defined as “hemp.” And there sat on my desk a 300+ page proposed rule to do so.
I didn’t know from hemp, so I sitting on my office couch I read the whole thing before embarking on a multi-month negotiation amongst the various Executive Branch interests to settle on a federal regulation to permit legal growing, processing, and selling of the psychoactive plant Cannabis sativa L.
This ended up being prong two of my looking glass tumble down the psychedelic policy rabbit hole.
No Man in No Man’s Land
Here I was, in the post 2020-world, one of the few human beings on Earth with direct federal psychedelic-relevant policy experience. At this point I found some of the claims of potential benefits from medical use of psychedelics promising, though often breathless, to the degree I could determine such a thing.
So I became an unpaid advisor to a couple pro-psychedelic advocacy organizations. I merely wanted to offer my experience to help move forward the science of psychedelic medicine, and hopefully bolster the case for federal funding, research, and regulatory approval of potentially life-improving psychedelic medicine.
But what sprouted up around me was a whole ecosystem not so different from the adjacent cryptocurrency industry.
Overstatements.
Get rich quick schemes.
People claiming to be experts in the extremely narrow field that barely existed and in which only a few people had any actual direct experience.
One of the major conferences—I believe now defunct—called Wonderland (put on by an organization called Microdose, lol) promised:
“Panel insights on psychedelic substance-related industries and regulations
Dozens of experts, activists and innovators providing perspective, including athlete celebrities Mike Tyson and Lamar Odom”
And they weren’t unique. The famous Davos gathering put on by the World Economic Forum had an entire Psychedelic House in 2022.
Because what had happened was psychedelics had become a hot new thing, with plenty of money to be made. Big time VCs were suddenly pumping in billions of dollars. And an atmosphere of charlatans, fraudsters, and influencers flooded the zone accordingly.
Let the Good Times Roll
All of which was fine until, like all fads/bubbles, the conferences, the celebrity endorsements, and the ecstatic funding all fell back to Earth.
In August 2024, the oldest and most established psychedelic research organization (formerly MAPS, then Lykos Therapeutics, now Resilient Pharmaceuticals) ran into the entirely foreseeable wall of not knowing WTF they were doing. Their application for FDA approval for MDMA was denied.
Later the same year, Compass Pathways (backed by $360 million from prominent investors like Peter Thiel, Mike Novogratz, and Christian Angermayer) also missed the rim in their MDMA application. Which led their stock to tank and a 30 percent reduction in staff.
In 2025, in spite of an HHS Secretary favorable to psychedelics, Compass Pathways was cut from the FDA’s new fast-track review pathway (although a 2026 Executive Order put them back on).
It must’ve been love, but it's over now…
It had all moved so fast and well beyond my knowledge and interest, so I backed away. Out of curiosity I catch various goings-on as they cross my desk: MAPS making personal attacks on Psymposia, surfacing troubling abuse allegations, failure to solve the double-blind problem in clinical trials.
I’ve chosen to have no substantive role for a couple years now, but if anyone asks, I’m happy to provide free advice.
[If you’re curious, the last time I said anything on the record was in 2023 on the Psychedelics Today podcast]
Forgoing the details, the basic contours are this. To get FDA “marketing authorization” for a new drug typically requires clinical testing in three phases of in-human trials: phase I for baseline safety evidence and phases II/III investigating effectiveness.
Might as well stand on business here: them goobers was all cap. They told on themselves as direct mouthpieces for the opposition, but thinking we couldn’t see the mask slipping. Actively undermining passage, willing to straight up lie, and making us repeatedly walk over to their office in that cosplay Lord of the Flies amusement park ride they call the House of Representatives. Anyway we dusted them and I could only laugh when they showed up at the bill signing scenario at the White House. Washington!
There was this guy (who I guess has taken to wearing a toupee, now working alongside this guy who was at PhRMA), and this hobbit guy. All of whom tirelessly worked in bad faith, unafraid as they were to lie to us and undermine our efforts at passage at every step.
We convinced The Wall Street Journal to run editorials when they needed to be smacked into place, like this one when they screwed with the House vote. I even ghostwrote an op-ed there.
The law would end up applying to a preexisting statutory definition of “life-threatening illness,” for drugs beyond phase I testing and continuing on, and companies willing to provide it at cost. The FDA would not be allowed to require data from these patients in their approval application.
The Hill (which to be fair will publish anyone including me), even ran an op-ed by an artless law student in the midst of the debate, seeing as it was during a competitive election campaign.
Libertarian priors mean I would be personally perfectly fine with application of RTT to experimental use of DEA scheduled psychedelic substances, but no one asked me my opinion. If they had, they would hear how the law did not in fact exempt existing DEA requirements that prevented access to certain drugs as is subject to the case.