MICHEL MARTIN, HOST:
MDMA is what we're going to talk about now. That's a party drug. It's usually associated with all-night raves, but one company is seeking FDA approval to use it as a mainstream treatment in mental health care.
A MARTÍNEZ, HOST:
Yeah, today, a panel of experts to the Food and Drug Administration will review the evidence behind using MDMA to treat post-traumatic stress disorder, what they say could affect whether the agency approves the treatment.
MARTIN: NPR's Will Stone is with us now to tell us more about this. Good morning.
WILL STONE, BYLINE: Good morning.
MARTIN: So this treatment is called MDMA-assisted therapy. How does it work?
STONE: Well, it basically combines a form of talk therapy with the psychedelic drug MDMA. So a patient with PTSD gets a dose and then works through their trauma with two therapists. The clinical trial involved several of these dosing sessions. FDA staff have said, based on that data, participants appear to experience, quote, "rapid, clinically meaningful, durable improvement in their PTSD symptoms." I asked Dr. Mason Marks about the chances of approval for MDMA. He studies psychedelics at Harvard and Florida State University.
MASON MARKS: At first glance, the data looks promising. There are also legitimate questions. But just looking at the totality of the circumstances, I suspect it will be approved.
STONE: In fact, the drug company that's funded this research, called Lykos Therapeutics, has raised more than $100 million ahead of possible FDA approval.
MARTIN: So Dr. Marks referred to legitimate questions. What are those questions?
STONE: That's right. This is not a done deal because there are questions about whether the findings from the trials are solid. And one big concern is that most people in the trials could tell whether they received MDMA or a placebo. Ideally in clinical trials, people can't tell. Obviously, that's hard to do with psychedelics. But ultimately, when this does happen, it can lead to bias and that skews the results. There are other concerns about the methods and long-term data. But what's caught attention more recently are inflammatory allegations about the trials.
MARTIN: OK, so what are those?
STONE: Essentially, there are claims that some therapists and investigators may have pushed patients to report good results and overlooked adverse events. That was emphasized in a recent report from the Institute for Clinical and Economic Review. This is an independent group that did a deep dive into the data and said there were substantial concerns about the validity of the results. Some of that is based on what trial participants have said. Sarah McNamee was in one of the trials. Take a listen to part of her public testimony read by a friend.
UNIDENTIFIED PERSON: Three months after I was given my first dose of MDMA, I was for a time one of the staunchest advocates for MDMA therapy. The problem is that I was also suicidal and clinically decompensating in drastic and unprecedented ways.
STONE: And what she means by that is, basically, she was having worsening symptoms. And McNamee says her therapist played up the idea that she was helping make history. And she says others in the trials have also shared with her negative experiences that did not get fully captured in the published findings.
MARTIN: So what could this mean for possible approval of the treatment?
STONE: The drugmaker, Lykos, has pushed back on these allegations and said they stand by their results. And there are certainly many who do feel MDMA should be approved, including groups representing military veterans. Here's former Army Ranger Jesse Gould with the nonprofit called Heroic Hearts Project.
JESSE GOULD: If not MDMA, there really is nothing else out there in the pipeline.
STONE: So this panel of advisers will have to weigh all of this because the FDA wants to make a decision by early August.
MARTIN: That is NPR's Will Stone. Will, thank you.
STONE: Thank you. Transcript provided by NPR, Copyright NPR.
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