Rick Doblin

What that means is everybody's similarly motivated, and they will work, and the therapists don't know necessarily. So you do this random assignment. But then the second thing is that you can't have the therapists or the patients rate themselves on how well they've done compared to baseline. You need independent raters. that are blind to the condition that the person that they're evaluating is in.

What that means is everybody's similarly motivated, and they will work, and the therapists don't know necessarily. So you do this random assignment. But then the second thing is that you can't have the therapists or the patients rate themselves on how well they've done compared to baseline. You need independent raters. that are blind to the condition that the person that they're evaluating is in.

What that means is everybody's similarly motivated, and they will work, and the therapists don't know necessarily. So you do this random assignment. But then the second thing is that you can't have the therapists or the patients rate themselves on how well they've done compared to baseline. You need independent raters. that are blind to the condition that the person that they're evaluating is in.

So the raters don't know, did this person get the placebo? Did this person get the MDMA?

So the raters don't know, did this person get the placebo? Did this person get the MDMA?

So the raters don't know, did this person get the placebo? Did this person get the MDMA?

Well, this is afterwards. And it's done on telemedicine. It's done on Zoom. And it's an hour-long interview. And it's with what's called the CAPS, the Clinician Administered PTSD Scale.

Well, this is afterwards. And it's done on telemedicine. It's done on Zoom. And it's an hour-long interview. And it's with what's called the CAPS, the Clinician Administered PTSD Scale.

Well, this is afterwards. And it's done on telemedicine. It's done on Zoom. And it's an hour-long interview. And it's with what's called the CAPS, the Clinician Administered PTSD Scale.

Yeah. Yeah. It's like an hour long interview about their symptoms related to what they call the index trauma, which is the worst thing that ever happened. You pick this. This is my index trauma. And how do you respond? So we had these independent raters and then we had this random assignment. And that's what the FDA said is how we should do the phase three studies.

Yeah. Yeah. It's like an hour long interview about their symptoms related to what they call the index trauma, which is the worst thing that ever happened. You pick this. This is my index trauma. And how do you respond? So we had these independent raters and then we had this random assignment. And that's what the FDA said is how we should do the phase three studies.

Yeah. Yeah. It's like an hour long interview about their symptoms related to what they call the index trauma, which is the worst thing that ever happened. You pick this. This is my index trauma. And how do you respond? So we had these independent raters and then we had this random assignment. And that's what the FDA said is how we should do the phase three studies.

What was problematic for us was the people at the FDA that we negotiated this with in 2017 then left the FDA. And then new, more conservative people came in at the Division of Psychiatry. And they were more concerned about this, what they called functional unblinding.

What was problematic for us was the people at the FDA that we negotiated this with in 2017 then left the FDA. And then new, more conservative people came in at the Division of Psychiatry. And they were more concerned about this, what they called functional unblinding.

What was problematic for us was the people at the FDA that we negotiated this with in 2017 then left the FDA. And then new, more conservative people came in at the Division of Psychiatry. And they were more concerned about this, what they called functional unblinding.

And that became an issue at the FDA Advisory Committee meeting and at the FDA when they reviewed whether to approve MDMA-assisted therapy or not. And so the pharma company, Lycos, did not really proactively explain to the advisory committee how this design was developed, why FDA chose this. design.

And that became an issue at the FDA Advisory Committee meeting and at the FDA when they reviewed whether to approve MDMA-assisted therapy or not. And so the pharma company, Lycos, did not really proactively explain to the advisory committee how this design was developed, why FDA chose this. design.

And that became an issue at the FDA Advisory Committee meeting and at the FDA when they reviewed whether to approve MDMA-assisted therapy or not. And so the pharma company, Lycos, did not really proactively explain to the advisory committee how this design was developed, why FDA chose this. design.

And so the people in the advisory committee are often more academics, and they're more focused on this double-blind issue, but they're not practical in a sense. So that the FDA realizes that the double-blind fails in practice a lot. It's a theory of how you want to do things. It's something to strive for, but it doesn't work a lot of the times.

And so the people in the advisory committee are often more academics, and they're more focused on this double-blind issue, but they're not practical in a sense. So that the FDA realizes that the double-blind fails in practice a lot. It's a theory of how you want to do things. It's something to strive for, but it doesn't work a lot of the times.