How fast should medical breakthroughs reach patients?
What evidence should be required before promising interventions become widely available?
What’s at stake
Waiting can harm patients who might benefit from a treatment. Moving too quickly can expose them to ineffective or dangerous interventions. The central question is how evidence, access and monitoring fit together, especially when enthusiastic personal accounts move faster than controlled studies.
The ideas that connect
Promising experiences should generate tests
Ricks distinguishes watching biohacking experiments from recommending a treatment supported by clinical studies. Johnson’s discussion of psychedelic risks also acknowledges that supervision and known dosing do not make every person a suitable candidate. The common issue is the gap between a plausible experience and a dependable claim about benefit or safety across patients.
Supporting passages
2025-09-29
There's lots of communities like this trying different things. We don't ever recommend that because we live in a world of clinical studies and FDA approvals.
There are broad, well, we're pursuing them in the path we do, which is taking those disease states or people with the pre-disease state, like pre-diabetes, and then we study it and we prove an outcome. We did that with Monjaro and showed a 93% reduction in conversion from pre-diabetes to diabetes. That's how we work is slicing the medical stack. These guys are coming out at the other way, which is saying, I'm already healthy, can I generally stay healthier with small doses or other regimens, supplements? That's not our game, but we watch it.
Open the source and seek to the timestamp above.
2026-03-26
They don't know what the dose of psilocybin is. So it's like unquantified, unsupervised, wrong set and setting. And so much of it, I think you can, the risk persists, but I don't think we've, we've approached psychedelics with the appropriate rigor that we should to make it safe. And so it's not to say that we can solve for the safety issues for all people. Some people may not be the appropriate candidate for it, but I think if we do create a safety structure around it, they could deliver the benefits people want without, you know, with less of the risk. But definitely I agree with you. Like it's again, it deserves all the caution in the world.
Open the source and seek to the timestamp above.
Approval can begin a new phase of evidence
Makary’s proposal treats post-approval monitoring as an active search for adverse events, interactions and effects in particular groups. That addresses a problem also visible in self-experimentation: outcomes differ across people and may appear over time. Faster access is more defensible when the system can detect problems and respond, not when approval is treated as the end of learning.
Supporting passages
2026-01-15
And we can use Bayesian statistics, which we announced this week, a big sort of new milestone with that. And I want to see us continue to have eyes on a drug after approval. So approval is sort of a point where we say, hey, the world can use it with a fair degree of confidence on the safety and efficacy trade-off. But why did we learn five years after Vioxx was approved that it may have killed 38,000 people? Well, in the modern world with big data, we can have eyes on a drug as it's being used in real time to call out that safety signal immediately and let people know it. Maybe a subgroup of people that are affected, maybe a drug-drug interaction. You know, you think about the opioid epidemic, 15 years of prescribing it, having no idea.
Open the source and seek to the timestamp above.
2026-03-26
They don't know what the dose of psilocybin is. So it's like unquantified, unsupervised, wrong set and setting. And so much of it, I think you can, the risk persists, but I don't think we've, we've approached psychedelics with the appropriate rigor that we should to make it safe. And so it's not to say that we can solve for the safety issues for all people. Some people may not be the appropriate candidate for it, but I think if we do create a safety structure around it, they could deliver the benefits people want without, you know, with less of the risk. But definitely I agree with you. Like it's again, it deserves all the caution in the world.
Open the source and seek to the timestamp above.
Access and endorsement are different decisions
Allowing investigational access does not establish that an intervention works. Makary’s right-to-try argument combines flexibility with concern about ineffective, expensive treatments; Ricks draws a firmer boundary around clinical evidence before recommendation. This is the real tension: how much uncertainty a patient may choose to accept, and what public institutions or companies should claim on that patient’s behalf.
Supporting passages
2026-01-15
It's an amazing achievement of President Trump in his first term. And I have signed 100% of right to try requests that come across my desk. Of course, the companies have to agree to make the medication available. But it's a great program. And like, we don't want people getting spun up on snake oil that doesn't work, that's cost $3 million, where their churches are doing GoFundMe campaigns, when we know a drug does not work. So we do have a responsibility. And we have to be good stewards of the Medicare program. They're using taxpayer dollars to fund things. But if there's a signal that something works and somebody wants to try a drug, who are we to say you can't? So we look at safety, but beyond safety, we have to be as flexible as possible with our regulation.
Open the source and seek to the timestamp above.
2025-09-29
There's lots of communities like this trying different things. We don't ever recommend that because we live in a world of clinical studies and FDA approvals.
There are broad, well, we're pursuing them in the path we do, which is taking those disease states or people with the pre-disease state, like pre-diabetes, and then we study it and we prove an outcome. We did that with Monjaro and showed a 93% reduction in conversion from pre-diabetes to diabetes. That's how we work is slicing the medical stack. These guys are coming out at the other way, which is saying, I'm already healthy, can I generally stay healthier with small doses or other regimens, supplements? That's not our game, but we watch it.
Open the source and seek to the timestamp above.
What remains unresolved
What evidence supports the specific outcome, for which patients, and how will harms be detected? These are questions about evaluating treatments, not recommendations to try them.
A selected guide · September 2025–September 4, 2026 · Sources and method