‘To the surprise of almost everyone involved, therapy using MDMA — commonly known as ecstasy — will probably not become legal this year. That’s because Lykos Therapeutics, the company trying to get it approved by the Federal Drug Administration (FDA), came under fire at a public hearing on June 4 over questions about whether MDMA plus therapy effectively treats PTSD and concerns about the safety of Lykos’s therapeutic approach.
After researchers put the company on blast, the FDA’s advisory committee voted against approval, though a final decision will be made by the agency in August.
There were lots of problems with the evidence about the drug itself. In Lykos’s clinical trials, participants who got MDMA experienced a significant reduction in their PTSD symptoms, doing better than those who got a placebo, but almost all the trial participants could tell which one they were getting. So, to what extent were those who got MDMA healing because they knew they were getting the real drug and expecting that it would help them? No one can tell.
Regulators also weren’t sure if MDMA would harm the liver or cardiovascular system in the long term because Lykos didn’t gather evidence for long enough to know. And we don’t know about the drug’s addictive potential because Lykos failed to report on addiction-driving effects like euphoria; worse, some claim that Lykos pressured participants not to mention bad outcomes….’ (Vox)
MDMA has long been available through channels other than a profit-driven pharmaceutical company; there ought to be access to less tainted data about efficacy and tolerability. And, with psychedelic research, it seems inherently flawed to rely on placebo-controlled studies without a clever workaround for the fact (as noted) that subjects will always recognize from how they feel that they have gotten the active agent.
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