The FDA said there wasn't enough data showing the drugs helped patients and asked for another clinical trial.
The US has denied a bid to allow MDMA, commonly known as ecstasy or molly, to be used in the treatment for post-traumatic stress disorder (PTSD).
The US Food and Drug Administration (FDA) was examining the psychedelic drug made by Lykos Therapeutics to treat the mental health disorder in combination with talk therapy.
Personally, I want FDA approval to mean it is as provably safe and effective as possible. They said they wanted more evidence before approval, and I think that’s okay. Good, even.
The way the US treats recreational drug use and self-medication is horrific, but it’s not really the domain of the FDA.
I would rather have not-yet-FDA-approved legal-for-personal-use mdma than what we have now or an unproven drug approved by the FDA.
Shouldn't it need to be shown to be unsafe to remove people's choice to use it though? Proving it safe would be great, but the claim to prevent usage should be that it's harmful. It's removing a choice. We shouldn't have to prove everything is safe to be allowed to do it. We do plenty of things that are unsafe, but these drugs aren't allowed for no good reason.
K, well, you also have the choice to eat literally any mushroom you find growing in the ground, doesn't mean it'd be legal to sell them as shishkabs on the street. Wtf are you on about mate
When they deny something like this because of claimed flaws in study, do they give detailed descriptions of the flaws and help (maybe for a fee) the petitioner make a new study?
Or do they leave it vague enough so they can just perpetually say it's flawed?