FDA Expands Probe of Ecstasy-Based Drug Studies (arstechnica.com) 32
ole_timer shares a report from Ars Technica, written by Beth Mole There's more bad news for the company behind an experimental MDMA therapy for post-traumatic stress disorder, which the Food and Drug Administration roundly rejected earlier this month. According to a report from The Wall Street Journal, the FDA is now expanding an investigation into clinical trials behind the experimental psychedelic therapy -- even though the agency has already rejected it. Agency investigators reportedly interviewed four additional people last week, asking questions regarding whether the trials underreported side effects.
People involved in the trial have previously alleged, among other things, that ill effects, such as suicidal thoughts, went undocumented, and trial participants were discouraged from reporting them to bolster the chances of FDA approval. Overall, the MDMA trials faced crushing criticism amid the FDA's review, with outside experts and agency advisers calling out allegations of sexual misconduct at one trial site, as well as flaws in overall trial designs, multiple sources of biases, and claims that the company behind the therapy, Lykos, fostered a cult-like belief in psychedelics.
According to the Journal, the recent interviews were being conducted by the FDA's Office of Regulatory Affairs, which oversees inspections, and a subdivision of that office called Biomedical Research Monitoring Program, which works to ensure the quality and integrity of data submitted to FDA. Notably, when the agency rejected MDMA, it advised Lykos to conduct a new trial. While the FDA's rejection and expanded investigation are bad enough for Lykos, the company announced this month that it's laying off 75 percent of its staff and overhauling its leadership. The moves were in response to the FDA's rejections, the company said. Additionally, a scientific journal retracted three of the company's MDMA studies, citing "protocol violations amounting to unethical conduct" in its trials, echoing claims raised amid the FDA review.
People involved in the trial have previously alleged, among other things, that ill effects, such as suicidal thoughts, went undocumented, and trial participants were discouraged from reporting them to bolster the chances of FDA approval. Overall, the MDMA trials faced crushing criticism amid the FDA's review, with outside experts and agency advisers calling out allegations of sexual misconduct at one trial site, as well as flaws in overall trial designs, multiple sources of biases, and claims that the company behind the therapy, Lykos, fostered a cult-like belief in psychedelics.
According to the Journal, the recent interviews were being conducted by the FDA's Office of Regulatory Affairs, which oversees inspections, and a subdivision of that office called Biomedical Research Monitoring Program, which works to ensure the quality and integrity of data submitted to FDA. Notably, when the agency rejected MDMA, it advised Lykos to conduct a new trial. While the FDA's rejection and expanded investigation are bad enough for Lykos, the company announced this month that it's laying off 75 percent of its staff and overhauling its leadership. The moves were in response to the FDA's rejections, the company said. Additionally, a scientific journal retracted three of the company's MDMA studies, citing "protocol violations amounting to unethical conduct" in its trials, echoing claims raised amid the FDA review.
Wow, you don't say (Score:1)
Re: Wow, you don't say (Score:3)
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The complaint isn't that patients had suicidal thoughts. Those happen, can be addressed, and the patient can be supported. The complaint is that patients were discouraged from reporting such thoughts.
There's no such thing as a placebo psychedelic substance, so you can't blind the patients to whether they're in the control or treatment group. That means it's more important to have unbiased feedback on subjective effects of the treatment. It's pretty bad misconduct for the researchers to try to inject tha
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The complaint isn't that patients had suicidal thoughts. Those happen, can be addressed, and the patient can be supported. The complaint is that patients were discouraged from reporting such thoughts.
There's no such thing as a placebo psychedelic substance, so you can't blind the patients to whether they're in the control or treatment group. That means it's more important to have unbiased feedback on subjective effects of the treatment. It's pretty bad misconduct for the researchers to try to inject that kind of bias.
I agree with the first paragraph, and the last sentence, but disagree on the placebo comment. I have known a number of people who thought they were taking a psychedelic when they were not and absolutely reacted as though they were. The brain is very powerful, as is one's perception of reality. I'm not saying the placebo would be effective for everyone by any means, but they're not effective for everyone in regular control groups, either.
Regardless, Lykos [lykospbc.com] (as opposed to Lycos [wikipedia.org], which is what I thought of w
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Check this out (Score:2)
There's an open position at the lab; they need a janitor who's flexible and doesn't mind doing occasional errands here and there. No need to
do stand-up as pay is negotiable
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Re: braindead (Score:2, Troll)
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Re: braindead (Score:2)
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Used in small doses there is no effect. Anyone who has read Pihkal knows this, let alone people who are actually familiar with it.
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Used in small doses and keeping the serotonin at the proper levels and yes it's actually wonderful for depression. Anyone with a passing knowledge of it would know this.
So everyone knows that you get the euphoria, but never a crash?
So what is the proper amount that only does that? Do they use no longer teeth grinding as the metric? When it stops, the person is now happy and well adjusted?
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Now if only we had a way to find out...
Something like like looking at data really REALLY hard.
Something like trying to remember, and piece together information.
Something like STUDYing for an exam....
Oh wait, I got it, we can do a scientific study!
Granted it seems like these monkeys didn't exactly do that, but that doesn't mean proper studies can't be done, and that the correlated benefits can't be found to have causative roots. It's just going to have to be done in the proper scientific method.
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Now if only we had a way to find out...
Something like like looking at data really REALLY hard.
Something like trying to remember, and piece together information.
Something like STUDYing for an exam....
Oh wait, I got it, we can do a scientific study!
Granted it seems like these monkeys didn't exactly do that, but that doesn't mean proper studies can't be done, and that the correlated benefits can't be found to have causative roots. It's just going to have to be done in the proper scientific method.
I'll bet you could give them some insight on the way to do it correctly.
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I doubt it
I think it's a serious problem that therapeutic use of MDMA is prohibited, but the (granted anecdotal) evidence is that micro dosing or continual dosing is not a good idea.
I think the value of MDMA is that anything (probably not actually anything) that can be helped with therapy can be helped quicker and with better results using MDMA to juice the therapy session.
It allows the patient, to without fear or shame, be open and honest with their therapist. It also allows them to discuss traumatic thing
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You seem to have confused MDMA with LSD. Microdosing acid has become a hip thing, but I'm not sure it's effective either. I prefer megadoses myself, 600ug-1mg.
Re: braindead (Score:2)
Re:braindead (Score:4, Informative)
Re: braindead (Score:2, Informative)
You're stupid as fuck, go apply for that janitor job.
Re:braindead (Score:4, Informative)
really? all published studies i could find about that seem to somehow trace back to "maps pbc" which are actually these same people renamed, which seem to have shown really por ethics as per tfa. looking at their presentations more than actually doing research they seem to be in search for justification for what they already consider a therapy they want to get approved. i would say the reverse approach is advised: first you research the effect, then the findings might suggest possible threapies.
the studies themselves do show "some" promise which is based on some scoring of symptoms that seems a bit subjective to me (then again, much in psychology is subjective too). they are however huge walls of references and literature, often tangentially related to the experiment, with not much substance, which is why i haven't gotten to read them in detail.
if you know of other studies on this (not related to the same source) it would be interesting to check them out. i definitely don't think this research should be ruled out, but these people do indeed seem fishy.
then again i understand that a person under mdma effect might be indeed more open and receptive to therapy received at that moment, which is what they're saying. but it is really counterintuitive that a substance with such a mechnism of action and its well known negative after-effects would be helpful in the long run, as opposed to truly psychotropic substances like psylocibin which have none of these consequences and for which more plural research is available.
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Re:braindead (Score:5, Informative)
PTSD != depression
Also, the point of MDMA therapies is not the immediate effects of the substance, which would require continued intake, but to effect lasting change from the experience.
There is more than enough anecdotal evidence for this (also for other conditions than PTSD) to warrant serious investigation, but of course the research needs to be conducted by professionals to professional standards, not by these raving (heh) idiots.
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anyone with even a passing interest in drugs will tell you about tuesday blues. using mdma for depression seems like the most braindead move a doctor could make
I agree, the Crash seems to be an integral part of MDMA use. I suppose the idea was to find some level that enabled the euphoria, but didn't cause a dopamine crash. My money is on that not happening.
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Lots of phychoactive drugs have unpleasant side effects, including weight gain, loss of sex drive, drowsiness, suicidal ideation, etc. As long as the therapeutic benefit outweighs the downside of the side effect, it's not necessarily a showstopper. For MDMA in this application, if the benefit is permanent or very long-lasting, the patient could probably be supported through a few dopamine crashes.
For PTSD, MDMA Can Help - But Needs People (Score:2)