EXCLUSIVE: Interview with Rick Doblin on Allegations of Therapist Bias in MDMA Therapy Trials
A few months ago, the FDA strangely rejected MDMA-assisted therapy for PTSD, despite finding unprecedented rates of efficacy — and a decades-long, known safety profile that has stood the test of time (despite serious NIH propaganda efforts I wrote about here).
I previously wrote about the FDA’s decision compared with their new umpteenth mRNA booster approval and recommendation:
I reached out to Rick Doblin, the pioneer of the MDMA therapy protocols for PTSD, and discuss the inflammatory allegation that the therapists in the MAPS trials were strongly biased in favour of MDMA, leading to under-reporting of adverse events.
I pressed Rick on this very serious issue and — to his credit — he made some cogent arguments demonstrating the therapists in the study were not as biased as the viral Wall Street Journal investigation on the MDMA trials suggested (read the very last part).
Below is my full interview with him.
Rav: Do you have any hope about future MDMA approval, despite the FDA rejection?
Rick: A lot of people are going to suffer who could have benefited from MDMA-assisted therapy now rather than waiting until months or years. Lykos will succeed, however. They will make MDMA into a medicine for controlled, therapeutic settings. They'll figure out what FDA wants. They'll show it to them.
Rav: What kind of measures were taken in the MDMA trials to capture adverse events like suicidal ideation?
Rick: Our scientific priority was that each individual person report accurately what happened to them, benefits and harms. The FDA required that we had a robust system of independent raters blind to whether the subject received MDMA or placebo. Raters are responsible for administering the tests that measure symptoms of PTSD, depression, or other conditions in the clinical trial protocol. The therapists aren't the ones who rate the patients and the patients don't self-report. There's measures inside the hour-long interview by the independent raters are designed to determine if there is internal consistency with what is being reported.
(Note to readers: the therapists do measure suicidality — it is assessed more than 30 times throughout the trial.)
Rav: Let’s delve into the specific allegations made by a couple of trial participants that they didn’t feel like reporting their adverse events.
Rick: There were 15 sites for the first Phase 3 study (at institutions like UCSF and NYU) with over a hundred therapists working on both Phase 3 studies. There were almost 200 people with PTSD in Phase 3 and another 100 in Phase 2, with 100+ subjects in a range of other studies. A few subjects have reported that they felt pressure not to report adverse events since the study was "historic" and of an FDA-designated breakthrough therapy that could potentially help millions. I'm sad to hear they felt that way and assume that their therapists did not intend to send that message. If they did, it was wrong , unethical, and unscientific. I encourage these subjects to contact Lykos to report any adverse events that aren't already in their research records.
Rav: Do you think it’s a problem that some therapists highlighted this trial being a “historic” breakthrough in modern medicine?
Rick: I think it's fine for therapists to say this could be a historic breakthrough and they've seen it work in other people, if they actually have. But then they need to go forward and say, “This doesn't work for everybody - it might not work for you. We are not good at predicting who will respond and who won't. There are risks. Let's just see what happens. Let's all try our best.”
We intentionally said let's work with the hardest cases. Many of the people in the studies were suicidal in some ways before starting the study. Almost 1/3 of these people had what's called "positive behavior," which means taking steps to end their own lives, prior to entering the study.
About 40% reported recent serious ideation, with over 90% reporting some prior suicidal ideation, and over 90% also qualified for depression. It's critical to track people's suicidal ideation before, during and after treatment, and to increase treatment frequency when needed. I've not yet heard of any suicides or attempts from people with PTSD in the MDMA group in Phase 3, though it could happen. There was a suicide attempt in the control group. No treatment works for everybody, which is why there needs to be an overall risk/benefit analysis.
Rav: As an aside, can you briefly explain how MDMA therapy may alleviate cases of suicidal ideation (I’ve heard of several veteran testimonies)?
Rick: If people have experienced suicidal ideation before MDMA-assisted therapy, it's quite possible that feeling the fear-reduction properties of MDMA (lowering activity in the amygdala) will enable people to recall and re-experience suicidal thoughts but within a safe, therapeutic context where they can process the trauma of the experience. Most people, but not all, will experience beneficial outcomes.
Rav: In terms of participant biases, I think it’s also important to note that MDMA has been demonized for decades as an extremely harmful party drug.
Rick: Society has so demonized MDMA that many people still think it causes Parkinson's, damages neurons containing dopamine and serotonin, creates holes in your brain, etc. These background influences may negatively impact subjects who have been repeatedly exposed to false claims that demonize and exaggerate the risks of MDMA. Some of the subjects in the study could have lingering fears, in addition to expectancy of therapeutic benefits. Of note, the expectancy effect will be increased if FDA approves prescription use, more so than just for a breakthrough therapy still being studied.
The FDA designated MDMA-assisted therapy for PTSD a breakthrough therapy. This doesn't mean that it is a breakthrough therapy, just tthat it might be. FDA approval is what will make it an actual breakthrough therapy.
Rav: How can we truly know if the therapists were biased or not? And how exactly?
Rick: As a counterpoint that's really important here, look at how good the placebo results were in the control group. Now, these people were not just receiving inactive placebo, they received therapy with inactive placebo which 75% of the subjects were sure was a placebo. 46% no longer had PTSD in the second Phase 3 study after therapy without MDMA. If the therapists were biased and trying to screw this up — if they thought that this was an historic study and they shouldn't report the adverse events and want subjects to speak highly about their benefits — they would have also tried to not do so well for the placebo people! But they did their best. The placebo group in this new therapeutic approach, this evidence -based therapy, did outstandingly well. The therapists were not showing evidence of bias. It's not that the results in the control group that just got therapy were somewhat worse than the currently available therapies. It's that they're as good or better than the other therapies and they have a lower dropout rate."
Watch a previous conversation I had with Rick Doblin a year ago (released earlier this year) here, where we discuss how he paired MDMA with PTSD in the study design. It’s a fascinating conversation:
Perhaps the influence of people like Jay B and RFK, we can turn some of this around in the next 4 years.
That's insane! Instead of not sending our youth to fight the insane wars, DARPA is working on new therapeutics,upgraded, to ease the symptoms of killing people!