FDA advisors voted against MDMA therapy – researchers are still fighting for it
FDA advisors voted against MDMA therapy – researchers are still fighting for it
A vote against using MDMA as part of therapy for PTSD has provoked a powerful backlash among researchers who study psychedelic drugs.
Some 13 million Americans struggle with post-traumatic stress disorder (PTSD). Existing therapies only bring relief for a fraction of patients, and new treatments are sorely needed, according to psychiatrists wrestling with the scale of the problem. So, there was distinct disappointment when an advisory committee at the US Food and Drug Administration (FDA) voted earlier this month against a therapy that many had hoped could offer the first new treatment for PTSD in 25 years.
A number of experts who study psychedelics have since spoken out in support of MDMA-assisted therapy for PTSD and have sharply criticised the recommendations of the FDA's Psychopharmacological Drugs Advisory Committee. But some are still optimistic that the treatment might be approved when the FDA delivers its final decision in August.
Ahead of the meeting, FDA approval of MDMA-assisted therapy for PTSD seemed likely, says Sandeep Nayak, an assistant professor of psychiatry at Johns Hopkins University, who investigates psychedelics as treatments for substance use and mood disorders. About two-thirds of people who received three sessions of MDMA and talk therapy no longer qualified for a PTSD diagnosis at the end of two Phase 3 clinical trials.
It's an outcome that is "almost double that of existing medications", says Gül Dölen, a neuroscientist at the University of California, Berkeley, who researches the mechanisms of how psychedelics achieve therapeutic effects. "What's more, [the treatment] led to durable improvements in these patients lasting at least six months."
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It's fine if you didn't read or don't like that study.
Those symptoms resolved by psilocybin are the same as the PTSD symptoms that MDMA hopes to treat one day.
You not liking a particular medication doesn't make it less effective or safe for people.
You might want to check out the news recently though,, MDMA is specifically not being approved last weekend this week because a safe therapy has not been found, unlike with psilocybin.
Psilocybin is safe, simple and effective.
Controlled studies have born this out.
You do know the hope is not to treat symptoms but underlying disorders, right?
That's close.
Ptsd is much more effectively treated when you deal with the symptoms and the disorder itself instead of just focusing on The disorder and ignoring the symptoms.
Luckily, psilocybin therapies work on both symptoms and disorders.
I mentioned symptoms specifically because MDMA therapies are specifically focused on the symptoms right now that psilocybin already effectively treats.
So you can take the effective and perfectly safe psilocybin therapy regimen to alleviate symptoms and the disorder itself while focusing on supplementing that treatment with more traditional therapies to dig deeper into the disorder.
I love psilocybin. I used to grow them and still am fond of them and encourage others to explore them.
But it treating similar symptoms to PTSD is not the same as having an 80% success rate with actual PTSD, which is the claim you're making and not the claim your study is making.
PTSD is not anxiety or depression, even if it can present with similar symptoms. Nor is it substance use disorder. It's trauma and it requires safety and community to unpack.
Psilocybin is great at helping us develop a deeper relationship with ourselves and life generally. But the hormones released during an MDMA session better facilitate safety and connection.
Honestly I'm not trying to convince you in particular because we've had this conversation before and you're unwilling to reexamine your own conclusions. But I'll keep correcting the narrative for others who come along.
I remember you had those blinders about MDMA.
It's easier for you to believe whatever it is you believe than to accept the scientific and therapeutic conclusions that disagree with your beliefs.
Ask for slanting the narrative. However you feel like it, yeah go for broke.
The numbers and consistent facts make it pretty easy for me to fix your mistakes anyway.
There's so much projection in your post it's ridiculous.
PTSD is not treatable with SSRIs. Depression is.
And the logic you are using is that because psilocybin works well for depression it will be great for PTSD.
We already know that's not the case when we look at other drugs used to treat depression and PTSD. Such as the SSRIs I just mentioned.
They're not the same disease and you are drawing false comparisons between the two. I have lived with CPTSD my entire life. I have tried multiple anxiety and depression treatments. And they didn't work that well, because I have PTSD and not anxiety or depression, those are simply symptoms. And I have taken psilocybin probably 50 times if not more. Because I enjoy it and it helps me clarify my relationship with myself. But it's not as good at helping me feel safe and connected to other human beings as MDMA is.
If MDMA therapy was available I would jump on it tomorrow because I know it would help me more.
I've been researching this stuff personally for over 30 years. Both through consumption and studying the pharmacology and scientific literature.
You seem to be like a first-year psychedelic therapist or something because I remember that class description that you linked, which you completely misinterpreted as well.
Does psilocybin have some potential in treating PTSD? Yes. Does the current scientific understanding suggest that it would be better than MDMA for this? No. In fact it suggests that MDMA is superior in treating PTSD. And psilocybin is superior for treating end of life anxiety and depression, assuming these symptoms aren't being caused by an underlying condition such as PTSD.
They are very different diseases. Even if the symptomology is similar, that doesn't mean the treatment is the same.
You claim to identify external projection by critiquing your own misunderstandings and assumptions about others.
I'm glad you personally like Molly and find it helpful.
It doesn't change how effective and safe psilocybin is.
You can like Molly 20% or 100% or a million percent personally, but that doesn't have any bearing on how safe and effective other therapies are at treating the same symptoms.
Again you conflate symptoms and disease.
I think that's all I need to point out for anybody following this conversation.
I understand it's easier for you to pretend I said something different than I said, but make-believe is not as convincing as you think it is.
MDMA is not ready as a therapy yet.
It isn't effective yet against the symptoms or disorder, and it isn't safe yet.
You should do all the drugs you want, drugs are great, but you shouldn't tell people not to take effective and safe therapies because you personally enjoy a drug that may have benefits in the future.
Psilocybin is here.
It helps with these problems.
MDMA does not yet have an effective therapy regimen.
9 out of 11 FDA researchers say:
Hold your horses
I'm not telling anyone not to take psilocybin. Don't put words in my mouth.
I'm questioning the bias in that FDA advisory board. A reasonable question considering decades of prohibition and that historically FDA advisory boards have owned stocks in pharmaceutical companies that stand to lose profits if MDMA is approved as a medication.
In other words, the 9 out of 11 statistic that you just cited is a statistic that I don't trust because these individuals have historically been biased and are not specialists in psychedelic medicine.
And your whole argument hinges on this idea that because we have a treatment that could be effective we should not look into more effective treatments. In which case, meditation works just fine for all of this and is much safer than any medication we can put in our body. So, should we not use any mental health medications? And put all of our research money just into meditation? After all it is safe and effective, and much safer than either of these drugs.
Question and enjoy whatever you like.
Meditation is not much safer than psilocybin.
Magic mushrooms are twice as safe as coffee.
Just because MdmA doesn't work, it doesn't mean that you don't have to use any therapies at all that do work.
This is the problem with your approach and conclusions.
You're so devoted to your personal experience with MDMA that when MDMA has been rejected, your next question is so then there's nothing?
That is not the logical conclusion.
The treatment you prefer is not yet safe or effective.
That's fine. There is a safe and effective treatment already.
Whatever else you are reading into this conclusion is your own.
There's nothing wrong with having effective solutions that don't jive with your personal preferences.
One has to wonder how many drugs you may have ingested that would make you think saying the same thing over and over again, without verifiable scientific proof (that is not simply a copy-pasta of an article in a tech mag) somehow proves your point.