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.
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?
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
That's fucked. Multiple studies have literally proven even a single MDMA session can CURE treatment resistant PTSD 2 times better then placebo. Oh... I see. Perhaps they don't want someone to take something once or just a couple of times and be cured. Call me crazy but I think they want you to keep taking something for life that won't cure you, but just help you manage it. Better for business.
Do you really, like actually believe the big pharma doesn't have any power/lobbying influence over FDA?
Not to be rude or anything, but that's IMO laughable.
Exactly. Why have a cheap, one off drug when you can make billions with something expensive that'll be needed for the duration of your life, and might possibly give you side effects that'll require additional drugs that they also happen to sell? To not do so would be socialism!