Taking Time to Reflect on the FDA's Decision on MDMA-Assisted Therapy
It's taken me a few days to process everything from the FDA advisory committee's recent vote on MDMA-assisted therapy for PTSD. As someone who has backed MAPS for six years, I want to share my thoughts.
The Long Journey and Current Setback
The committee's non-binding rejection of MDMA-assisted therapy is a tough moment for Lykos, MAPS, and the entire field of psychedelic therapy. This decision reminds us how fragile our progress is. Every victory has been hard-won over nearly 40 years. We can’t take our achievements for granted. We must be responsible, honest, and transparent and remember that we’re all together.
The Challenges We Face
Lykos was ready to answer tough questions at the FDA meeting, but they didn’t get the chance. Many of the issues raised by the committee have been discussed and negotiated with the FDA for years. The panel only had ten days to review data the FDA has examined for decades. This lack of understanding was clear during the hearing. The FDA's depth of knowledge contrasted sharply with the panel's.
Several inaccuracies came up:
Addiction and Diversion: There is no evidence from the trials suggesting MDMA leads to addiction or increased drug use. Concerns about diversion are mitigated by the high cost and tight regulation of the therapy.
Patient Selection: Claims that difficult-to-treat patients were screened out were inaccurate. 73.1% of participants in the Phase 3 trials had severe PTSD.
Demographic Representation: Assertions that the therapy only works for white people were contradicted by data showing that 53% of participants in the MAPP2 trial were people of color.
Physical Health Risks: Concerns about insufficient data on MDMA’s physical health risks overlook the extensive research conducted over the years.
The panel also didn't understand the combination of drug and therapy in MDMA-assisted treatment. This dual approach confused them, as they weren’t equipped to evaluate the therapeutic components of the treatment.
Moving Forward
We need to address the committee's concerns and continue advocating for the approval of MDMA-assisted therapy. Lykos and MAPS have a lot of data to clear up misunderstandings. They are committed to ensuring the treatment is safe and effective. The final FDA decision is expected by August 11th, and we need to support the teams involved.
Conclusion
This setback highlights the need for continued advocacy and education about the benefits of MDMA-assisted therapy. We can’t let prolonged decisions and unfounded concerns delay access to this potentially life-changing treatment. We can overcome these challenges and pave the way for better mental health care.
Neuma
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