Johnathan Edwards here, author of The Revolutionary Ketamine. My question is did the people at the FDA meeting consider that we are losing about 40 veterans per day to suicide. We used to think it was 20 per day. New data suggest the former. Also, this dark statistic doesn't even touch the number of veterans suffering from PTSD which seems to be better treated with MDMA versus ketamine or other psychedelics. Thank you. Johnathan Edwards MD
The FDA has no credibility when it comes to what they do and don't approve. They are not 'protecting people' with any of their decisions. Look at the mRNA disaster.
Taking psychodelics or MDMA under supervision of a doctor or 'spirit guide' or someone sober is being responsible. If you have ever been to a concert you have been around people doing many illegal drugs and for the most part they coexist without problems. They have no business restricting therapy that you could get at a concert.
Has anyone heard what Bessel van der Kolk may have had to say about the FDA's rejection? I believe he was one of the lead researchers in the MDMA MAPS trials based out of Boston.
I was at a "trauma week" in Costa Rica with Bessel in early 2022. He told me at the time that MDMA therapy was by far the best treatment for attachment trauma that he's seen.
Total shame this was not approved. The therapy will stay underground. In NYC the rates for such treatment with a LCSW are $1,000 per session. Completely out of pocket of course.
What were the reasons the FDA stated were the reason they denied approval? I think knowing this is important, and, given their denial reasons, what clinical data did they rely on to conclude denial was the right decision?
Johnathan Edwards here, author of The Revolutionary Ketamine. My question is did the people at the FDA meeting consider that we are losing about 40 veterans per day to suicide. We used to think it was 20 per day. New data suggest the former. Also, this dark statistic doesn't even touch the number of veterans suffering from PTSD which seems to be better treated with MDMA versus ketamine or other psychedelics. Thank you. Johnathan Edwards MD
The FDA has no credibility when it comes to what they do and don't approve. They are not 'protecting people' with any of their decisions. Look at the mRNA disaster.
Taking psychodelics or MDMA under supervision of a doctor or 'spirit guide' or someone sober is being responsible. If you have ever been to a concert you have been around people doing many illegal drugs and for the most part they coexist without problems. They have no business restricting therapy that you could get at a concert.
Has anyone heard what Bessel van der Kolk may have had to say about the FDA's rejection? I believe he was one of the lead researchers in the MDMA MAPS trials based out of Boston.
I was at a "trauma week" in Costa Rica with Bessel in early 2022. He told me at the time that MDMA therapy was by far the best treatment for attachment trauma that he's seen.
Total shame this was not approved. The therapy will stay underground. In NYC the rates for such treatment with a LCSW are $1,000 per session. Completely out of pocket of course.
I did not know this. Do you know how I could get in touch with him?
I just learned that he was part of a key clinical trial for sertraline (SSRI) for PTSD which lead the FDA to approve the drug. I did not know this.
What were the reasons the FDA stated were the reason they denied approval? I think knowing this is important, and, given their denial reasons, what clinical data did they rely on to conclude denial was the right decision?