Third and last session of #psychedelics@NIH ๐บ๐ฒ workshop starting now, looking at how to optimize clinical trials design and how to get these treatments approved ๐งต
Starting with Ido @hartogsohn ๐ฎ๐ฑ on psychedelic set and setting theory
Important Q โ
Do we have an (excessively) costly and complicated drug regulation apparatus?
Unblinding was the major issue in @Lykos_PBC MDMA efficacy review by @US_FDA's PDAC
In 2011 I started a post-doc with ayahuasca and figured out the obvious: double-blinding wouldn't work. In 2014 I discussed this at @Imperial_PRG without success
We need better epistemology ๐งต๐
It is striking how the field of evidence-based medicine (EBM) continuously endorses blinding as the most reliable control for post-randomization biases, when in fact there's much evidence to systemic failures and epistemic bias, as I presented at PS23
Less than 10% of biomedical RCTs measure and report unblinding, and many unblinded trials were published without disclosing this issue, including in top journals and for already approved medications.
7even years ago @PNASNews published results of our neuroimaging exploration with #LSD, bravely led daily by @RCarhartHarris and a young trio @LeorRoseman myself and @MendelKaelen in the early days of @Imperial_PRG, exploring unknown frontiers despite huge prejudice all around...
One day, with LSD inside my blood, I saw an unforgetable infinitude of things, including the MRI transform into a massive surgical robot laser-cutting thin slices of my brain which flew at light speed into the computer screen in the nearby room...
And I asked myself "Can they see my thoughts on screen"?
That seemed a silly idea and I laughed alone in the noisy cold room (relieved as other visions were of sensuous aesthetics, luckily never asked about ๐)...
This week #psychedelics, almost completely ignored by western science and medicine in the last quarter of the 20th century, made it to the top of ๐บ๐ธ healthcare, the @NIH:
4k folks ๐ 21 time zones
+10h of talks
Panelists from
๐บ๐ธ 12
๐จ๐ฆ 1
๐ฎ๐ฑ 1
๐ฉ๐ฐ 1
๐ฌ๐ง 1
๐ณ๐ฟ 1
๐จ๐ญ 1
๐งต summary ๐
Agenda comprised 3 main themes:
Basic and translational research ๐๐ฌ๐ฉโ๐ฌ๐จโ๐ฌ๐งฎ๐ป
Clinical trials ๐ฉโโ๏ธ๐งโโ๏ธ๐จโโ๏ธ๐คฎ๐๐ค๐
Optimising future trial designs ๐พ๐ฝ๐ฟ๐
Here are my remarks from 20y experience:
This is a good landmark to claim psychedelic science finally achieved maturity
Basic research is evolving rapidly and public funding ๐ฐis what is needed to transform the field
Clinical trials suggest transdiagnostic safety and efficacy