An FDA advisory committee is meeting today to review MDMA-assisted psychotherapy to treat PTSD. Follow STAT's live blog throughout the day for updates.
tl;dr: the methodology was a major issue. Some critiques include that participants knew what they got (not because they were told but because getting high on MDMA is kinda obvious), which calls into question the placebo effect
Well, sounds like the FDA isn’t the issue here then and they’re just doing their jobs. Pretty short-sighted of the researchers to cut corners and possibly torpedo potentially effective treatment being approved for even longer.
If the main problem was whether they knew they were on it or not. How are they going to fix that. You can’t exactly give the other group a different stim.
I think the only possible “double-blind” method would be to make the dosage sooo low, that it wouldn’t be noticeable, & therefore probably-wouldn’t produce any medically-useful effect.
IF the only dosage that works, is noticeable,
AND there is a regime auto-reject, on any study where the difference between placebo & tested-psychotropic is noticeable,
THEN that rule-regime prohibitsthe entire category of such interventions, from ever being considered valid.
That isn’t evidence-based-medicine: that, rather, is established-regime-based-medicine-that-IDENTIFIES-AS-evidence-based-medicine.
Quite a distinct difference…
Probably, what they need to do is use lowest-dose-that-produces-results & sooo many in the study that the statistics become undeniable…
There’s another issue, though…
New Scientist reported, perhaps last century, that MDMA-induced-euphoria was permanently burning out people’s ability to experience euphoria…
Which would explain the higher-depression-rate among former MDMA users nowadays, wouldn’t it?
Artificially-forcing a brain-system … does tend to have unfortunate consequences.
The “believers in MDMA” won’t tolerate that to be true, of course, any more than ideologues/believers/prejudices in ANY domain would permit actual-evidence to interfere with their belief…
A lot of drugs cause permanent problems when abused, and are still prescribed. Testing is needed to figure out if there’s safe dosing and whatnot. Worse, safe dosage for one person may be incredibly unsafe for another, just like with depression meds which can permanently cause mental issues (in addition to depression) at normally prescribed and “safe” dosages. This is why honest discussions and ongoing check ins with your doctor is vital in any prescription change. Hell, penicillin almost killed my mom, and that’s relatively safe unless you have an allergic reaction.
Definitely hard to test with drugs that offer non medical and very obvious side effects. Hopefully there is an interesting breakthrough in understanding mechanics so we can make safe PTSD helping meds, but something so drastically painful to the person having it may not have a safe cure because the systems that go haywire are so ingrained in the preservation systems of our brains.
Brains are weird. Any tampering is possibly dangerous.
tl;dr: the methodology was a major issue. Some critiques include that participants knew what they got (not because they were told but because getting high on MDMA is kinda obvious), which calls into question the placebo effect
Well, sounds like the FDA isn’t the issue here then and they’re just doing their jobs. Pretty short-sighted of the researchers to cut corners and possibly torpedo potentially effective treatment being approved for even longer.
Yeah, it’s not shocking that the FDA didn’t like it, although the research is promising
If the main problem was whether they knew they were on it or not. How are they going to fix that. You can’t exactly give the other group a different stim.
Precisely.
I think the only possible “double-blind” method would be to make the dosage sooo low, that it wouldn’t be noticeable, & therefore probably-wouldn’t produce any medically-useful effect.
IF the only dosage that works, is noticeable,
AND there is a regime auto-reject, on any study where the difference between placebo & tested-psychotropic is noticeable,
THEN that rule-regime prohibits the entire category of such interventions, from ever being considered valid.
That isn’t evidence-based-medicine: that, rather, is established-regime-based-medicine-that-IDENTIFIES-AS-evidence-based-medicine.
Quite a distinct difference…
Probably, what they need to do is use lowest-dose-that-produces-results & sooo many in the study that the statistics become undeniable…
There’s another issue, though…
New Scientist reported, perhaps last century, that MDMA-induced-euphoria was permanently burning out people’s ability to experience euphoria…
Which would explain the higher-depression-rate among former MDMA users nowadays, wouldn’t it?
Artificially-forcing a brain-system … does tend to have unfortunate consequences.
The “believers in MDMA” won’t tolerate that to be true, of course, any more than ideologues/believers/prejudices in ANY domain would permit actual-evidence to interfere with their belief…
_ /\ _
A lot of drugs cause permanent problems when abused, and are still prescribed. Testing is needed to figure out if there’s safe dosing and whatnot. Worse, safe dosage for one person may be incredibly unsafe for another, just like with depression meds which can permanently cause mental issues (in addition to depression) at normally prescribed and “safe” dosages. This is why honest discussions and ongoing check ins with your doctor is vital in any prescription change. Hell, penicillin almost killed my mom, and that’s relatively safe unless you have an allergic reaction.
Definitely hard to test with drugs that offer non medical and very obvious side effects. Hopefully there is an interesting breakthrough in understanding mechanics so we can make safe PTSD helping meds, but something so drastically painful to the person having it may not have a safe cure because the systems that go haywire are so ingrained in the preservation systems of our brains.
Brains are weird. Any tampering is possibly dangerous.