MDMA therapy for PTSD rejected by FDA panel
MDMA therapy for PTSD rejected by FDA panel
Scientific advisers to the US Food and Drug Administration vote overwhelmingly that the risks of MDMA treatment for post-traumatic stress disorder outweigh the benefits.
Ugh clickbait headline got me at first I thought the FDA themselves had made a decision already but this is about the independent advisors decision
Bottom of the article:
The FDA is expected to issue a decision in August
The issue is you can't do a double blind study on psychedelics.
Indeed, very difficult to surmount that obstacle. Makes me a little less confident in all the positive studies I've read over the years about MDMA efficacy for PTSD, which is a real bummer because it's very exciting to think MDMA can fill the gap in pharmaceutical treatments for PTSD (with therapy of course)
However I think that even if the FDA decides no in August, it just means a few more years of more rigorous studies are needed to get approval. That's would make sense since there is also some mention of other issues with the current studies.
I think MDMA for PTSD is too historically monumental to be hastily researched and approved. I think it's critical to have rock solid evidence of efficacy so that we can obliterate the demonization of psychedelics and wear down the crotchety stigma around what are really valuable and beneficial substances IMO
Interesting, seems like there main hangups are that you can't run against a placebo and that the two mdma trials they looked at was possibly biased for mdma (~40% of the participants had already tried mdma, and there was some questioning about bad experiences being discouraged from follow up) and that their focus was not on the therapy aspect of it, which they apparently don't judge. I guess I get their reasoning, but it stills seems like a waste as mdma isn't really that dangerous, and they could have at least recommended what needed to be changed to prove that mdma was beneficial.
Maybe see what happens with Australia given they've recently approved the use of Mdma for ptsd. Might be some interesting data to emerge.