Originally published at: FDA denies approval of MDMA-assisted therapy for PTSD - Boing Boing
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This is really disappointing. As there are millions in great need of a positive therapy. And the reason(s) this isn’t going ahead seem to be a strange mixture of definitions of what’s being approved (“a drug” or “a therapy” …utilizing a drug), and a lack of expertise on the FDA board about the clinical effects of psilocybin based therapies. BBC source
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Indeed. It’s a real setback. I struggle with anxiety and depression. The first is constant but the second is unpredictable and hits me at random times. Unfortunately cannabis seems to worsen my symptoms and make me nauseous. I’ve talked to my doctor about trying psilocybin, but we’re going to explore other options first. Finding the right balance of medication is a trial in itself.
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I thought the main reasons were the potential for abuse and boundary pushing by the therapists and the bias of the researchers. Certain data wasn’t reported, etc…
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I would be interested to know how much pharma lobby cash is behind this decision, especially given MAAPS non-profit status. Because of the legally fraught status of these compounds, dating back to the Nixon war on drugs era, MAAPS has been more than careful every step of the way in bringing these therapies into mainstream medicine. From my experience with FDA, if the right people haven’t already figured out a way to get filthy rich off of a new therapy, ain’t happening until they do.
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do not support maps here. what an irresponsible commentary! MAPS is an MDMA therapy cult - by Neşe Devenot
“The alleged use of psychedelics for exploitation supports the notion that MAPS/Lykos poses significant dangers for the public”
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MDMA seems like a good fit for treating PTSD.
Mushrooms too.
Or both.
At least my friend thinks so.
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If there were verified instances of hiding adverse events, there wouldn’t be a recommendation for a third trial. The therapy would be rejected with no chance of additional trials by this sponsor. And to be clear, there was no accusation of data not being reported. There was vague accusation of investigators downplaying potential adverse events with trial patients. Typically, the data isn’t controlled directly by either the trial sponsor or even the investigators. The data is controlled by a 3rd-party Clinical Research Organization (CRO) that has no vested interest in the outcome of the trial. At best, an investigator could put their thumb on the scale with patients. The sponsor has zero control over the data.
Potential for abuse? Compared to opioids!?! At least MDMA isn’t physically addictive. That concern seems overblown.
The concern from the panel about functional unblinding is a tough one, but it has to be solvable. I’m sure other drugs have had the same issue. Maybe there is a relatively safe stimulant that can be used instead of placebo for the control group if they do another trial.
The biggest legitimate concern is that the sponsor didn’t do a good enough job screening investigators. But concern about the risk “boundary pushing” by therapists seems strange. I mean, that comes with the territory. It’s almost like there was bias within the panel against therapy itself.
Ultimately, a 9-2 result from the advisory panel is tough to overcome. FDA almost always follows the panel’s advice. It does sound like a third trial is warranted, if they have the money to do it.
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[ article posted by Allan Rose Hill ]
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Thanks for the additional context.
With “boundary pushing” I was referring to the therapists sharing a bed and cuddling with the patient. If consent was given beforehand, that’s fine, but otherwise I would not say this kind of boundary pushing “comes with the territory”.
Also,… I agree that MDMA can have benefits, but I also understand the request for more research if the current research has some issues.
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The basic question in stories like this is always, Why should we trust the pharma company more than we trust the FDA? 
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That is clearly beyond “boundary pushing” way into unethical behavior and was what I meant by “failing to screen investigators adequately.” Those investigators should never have been allowed to be in the study.
Also note that the concern that the panel stated was the “risk of boundary pushing.” Excluding the clearly unethical behavior noted above, therapy inherently includes the risk of boundary pushing. I question whether that is a risk of this treatment or of any treatment for PTSD.
Once the protocol has been approved by FDA for the study, data collection and analysis is out of the pharma company’s hands and controlled by a 3rd party. The company gets to make statements at the panel meeting because otherwise, there really isn’t anyone to present it. The way our system works right now, a new drug or device that requires a clinical study for FDA approval needs a sponsor to pay for the study and make the applications for approval. Otherwise, nothing gets done at all.
ETA: And it should be noted that this “pharma company” was formed by a PTSD patient advocacy group, not Martin Shkreli. If anything, this model would be a vast improvement over the current system where most trials are done only if the pharma company thinks they can make billions off the drug. FDA has processes for drugs that treat less common (a.k.a. Profitable) conditions, but they are underutilized. This seems like a model that could change that.
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