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You're listening to Shortwave from

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NPR. Hey, Shortwavers,

0:23

Emily Kwong here with NPR science reporter

0:25

Will Stone, who's been reporting on the

0:28

use of psychedelics for therapy. Just

0:30

a heads up, we do mention suicide and

0:32

suicidal thoughts in this story. Will,

0:35

welcome. Let's get into this reporting. What

0:37

do you got? Hey, Emily,

0:39

I'm here to talk about MDMA.

0:41

That's the chemical found in ecstasy,

0:43

sometimes called Molly. Researchers

0:46

have been studying MDMA as

0:48

a potential therapy for post-traumatic

0:50

stress disorder, PTSD. And

0:52

in August, the FDA is expected to

0:54

decide whether it can be used as

0:57

a treatment option outside of clinical research.

0:59

Meaning it would be available to many more

1:01

people. This would be a big development.

1:04

It would, FDA approval would be actually

1:07

an enormous milestone for the movement

1:09

to bring psychedelics into the mainstream

1:11

of mental health care. Wow. But

1:14

recent allegations have sparked controversy over

1:16

the results from one of the

1:18

clinical trials, which could upset the

1:20

final stretch in the drug's path

1:22

to market. So today

1:24

on the show, how the government is

1:27

moving toward a decision about psychedelics and

1:29

mental health care. And how a

1:31

recent report questions the data the FDA

1:33

is using to make that decision. You

1:35

are listening to Shore Wave, the science podcast from

1:37

NPR. Support

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for just $15, go to

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mintmobile.com/Switch. Okay, well, before

2:57

we dive into some of the controversy, let's

2:59

just talk about where we are at

3:02

with psychedelics research. How does this decision fit

3:04

into all of that? So this upcoming

3:06

decision by the FDA will be kind

3:08

of like a test case for psychedelics.

3:10

After all, there's been just an explosion

3:13

of interest in these drugs and their

3:15

potential for mental health. Yeah, we've

3:17

been hearing about clinical studies for a while

3:19

now. Researchers looking

3:21

at psilocybin, at LSD, as

3:23

treatments. That's right, Emily. And

3:26

it turns out actually MDMA is further

3:28

along in the regulatory process than those

3:30

drugs because of decades

3:32

of work involving MDMA assisted therapy.

3:35

Okay, what is that? Like in

3:37

MDMA assisted therapy, do they just give people

3:40

the drugs and see what happens? Not

3:42

quite. It's actually a

3:44

pretty detailed protocol in which the

3:46

drug is given under the supervision

3:48

of two therapists. And there

3:50

are several what they call dosing sessions when

3:52

the person gets the drug. There

3:55

are also several follow up sessions to help people

3:57

process their experiences while on the

4:00

drug. So last year

4:02

results from a phase 3 clinical

4:04

trial were published by Nature Medicine.

4:07

The research was funded by the drug

4:09

company Lycos Therapeutics and it was conducted

4:11

by an international consortium of scientists. Okay.

4:14

And what did these clinical

4:16

trials find? So in one of

4:18

the trials, about 71% of

4:20

participants who took MDMA no longer

4:23

met the diagnostic criteria for PTSD

4:25

when they were assessed after the

4:27

treatment. Basically that means, generally, by

4:29

clinical standards, they did not have

4:31

PTSD anymore. Wow. And

4:34

by comparison, that number was 48% for

4:36

the control group. So those are people

4:38

who underwent the same therapy but took

4:40

a placebo instead of MDMA. There

4:42

needs to be more long-term data but

4:45

overall, this type of finding suggests this

4:47

could be a meaningful, potentially powerful

4:49

new treatment for PTSD. Many

4:52

people do not get that kind of relief

4:54

from other treatments. Yeah. I mean,

4:56

Will, you have been reporting on this

4:58

for a few years now. Have you

5:00

talked to anyone recently who's tried this

5:02

treatment? I have. Some people

5:04

have described it as absolutely transformational.

5:07

One of them is Casey Tyler, he's

5:09

a military veteran who is in the

5:12

phase 3 trials. Casey was actually in

5:14

the control group but he did have

5:16

the opportunity to do the MDMA treatment

5:18

after the study. We left Iraq

5:20

in 2009. We were not a small unit and there

5:22

are a lot of my friends who

5:25

have killed themselves and I really do feel

5:27

this would work. It's not going to work

5:29

for everybody but I think that it's going

5:31

to be one of the most effective tools

5:34

moving forward and it will save lives. I

5:36

know for a fact that it saved mine. Well,

5:39

that's as personal as it gets when you

5:41

talk about someone's relationship to

5:43

a treatment. It

5:45

is and there are many examples you'll

5:47

find in the media, public accounts from

5:50

people who say similar things.

5:53

Well, so every medical treatment comes with risks.

5:55

That's important for us to talk about as

5:57

a science podcast. What are some of the

5:59

downs? sides for MDMA assisted

6:01

therapy? Well, the trials

6:04

did document a variety of what

6:06

are called adverse events. This ranges

6:08

from nausea and anxiety to heart

6:11

palpitations, but overall the

6:13

treatment was considered generally well tolerated.

6:15

And in the trials, the authors

6:17

do acknowledge that consistent with PTSD,

6:19

there was some suicidal ideation in

6:22

both groups, but there was no

6:24

increase in adverse events related to

6:26

suicidality in the MDMA group. All

6:28

right, so that's the recap of these phase

6:31

three clinical trials, what

6:33

they revealed. Earlier,

6:35

you alluded though to some

6:37

controversy, like a report questioning

6:39

the trials and how

6:42

that may hinder FDA approval of using

6:44

MDMA as a therapy. So

6:46

what are the concerns? Right.

6:48

The report came from a nonprofit called

6:50

the Institute for Clinical and Economic Review.

6:53

This is an independent group that looks

6:55

at the evidence and analyzes whether

6:58

different treatments appear to be safe and

7:00

effective. And they try to put numbers

7:02

on how much treatment should cost and

7:04

their work can also help health insurers

7:06

make decisions about coverage. So

7:08

this Institute decided to do a deep

7:11

dive into the MDMA research. They came

7:13

out with a very skeptical report about

7:15

the strength of the data. And just

7:18

to boil it down, Emily, the

7:20

conclusion was there were quote, substantial

7:22

concerns about the validity of the

7:24

results of the MDMA clinical trials.

7:26

Okay, concerns about the validity of the

7:29

results. What were some of the accusations?

7:32

Yeah, so I'll just begin by saying

7:34

there's a lot here. But broadly speaking,

7:36

I would say there are two veins

7:38

of criticism. And the first is about

7:41

the study design, the methods. For

7:43

example, when you do clinical trials, it's really

7:45

important to try and make sure people

7:48

don't actually know if they got

7:50

the experimental treatment or a placebo.

7:53

Right. Of course, that is pretty

7:55

hard with psychedelics, people tend to

7:57

figure out if they were taking

7:59

a strong drug like MDMA

8:01

or psilocybin. In the

8:03

MDMA trials, most of those who got the

8:06

drug could tell this was not a placebo.

8:08

So like the participants could have reported

8:11

feeling better because they were like, aha,

8:13

I knew I had MDMA. Exactly.

8:15

The report also raises

8:18

concerns about the method used to

8:20

assess PTSD that it may have

8:22

shown improvements in symptoms related to

8:24

the specific trauma that they were

8:26

focused on in the therapy, but

8:28

maybe it did not capture the fact

8:30

that people were actually in worse shape

8:32

overall. So I would say, you know,

8:35

those issues fall into one bucket

8:37

of concerns outlined in the report.

8:40

Okay, so those are all having kind of to

8:42

do with methodology. What was the other

8:44

bucket of concerns? So

8:46

the other Emily was much

8:48

more inflammatory. The report brings

8:50

up the possibility that, quote,

8:52

very strong prior beliefs among

8:55

therapists, investigators and patients could

8:57

have influenced the results. It

9:00

points out that the therapist involved in

9:02

the trials and in some cases, the

9:04

patients to came from the psychedelic community

9:06

and already had beliefs about the treatment.

9:09

Here's Dr. David Rind. He is the

9:11

Institute's chief medical officer. Patients

9:14

may have been pushed to

9:16

report positive outcomes and pushed

9:18

away from reporting negative outcomes.

9:20

Huh. Okay. By

9:23

patients. I'm like, who is saying all

9:25

of this? So the report

9:27

did not name its sources, but David says

9:29

it included a small number of

9:31

people, including the therapist from

9:34

the trials and some of those involved

9:36

in a New York magazine podcast about

9:38

psychedelics. That podcast was

9:40

called Cover Story and it brought to

9:42

light video evidence of two therapists with

9:44

a trial participant. She was

9:47

under the influence of MDMA in a session

9:49

and described the therapist as having

9:51

inappropriate contact with her. And in the

9:53

video, you can see them in the

9:55

bed with her, pressed up

9:57

against her, kind of spooning. I

10:00

will say this was back in the Phase 2

10:02

trials. The podcast did also feature

10:04

two people who said they were in the

10:06

Phase 3 trials, the ones we've been talking

10:09

about. They were administered

10:11

MDMA, and they said

10:13

they experienced feelings of suicidality and other

10:15

distress after the studies, and they felt

10:17

that that wasn't really captured in the

10:20

data. Here is David again from the

10:22

Institute. You have a group of

10:24

people who are very upset about how

10:26

these trials went. We couldn't tell, even

10:29

though we talked with people where this

10:31

happened, whether that represents a tiny fraction

10:33

of bad events or a

10:35

number of bad events large enough to

10:38

have rendered the trial just not believable.

10:40

Wow, those are some really serious

10:42

allegations. Okay, so what is

10:44

the response been? What are

10:47

the groups that are pushing this

10:49

drug forward that are now under fire? So

10:51

first you have the nonprofit that

10:53

pioneered this research. It's called the

10:55

Multidisciplinary Association for Psychedelic Studies. It's

10:57

also known as MAPS. Then

11:00

you have the drug company that was incubated

11:02

by MAPS, which is known as Lycos Therapeutics.

11:05

Lycos sponsored the clinical trials, and is

11:07

the company seeking FDA approval to market

11:09

the drug? Right, right. Okay,

11:12

so what does MAPS say? So

11:14

in a statement, MAPS said it

11:16

remains fully supportive of comprehensive high-quality

11:18

research, careful analysis of safety and

11:20

efficacy, and stringent regulatory oversight of

11:22

any psychedelic assisted therapy or

11:24

research or delivery. They

11:27

also disputed some of the most troubling allegations that

11:29

came up in a petition to the FDA,

11:31

which I'll get to in a bit. Okay,

11:33

and what about the drug company? How did they respond?

11:36

A statement from Lycos made it clear that

11:38

the company stands behind the results of its

11:40

clinical trials. I spoke to

11:42

Willa Hall, who was a clinical psychologist

11:45

in the phase three trials. She rejected

11:47

the claims that bias influenced their results.

11:49

I saw nothing like that. I

11:51

only saw professionalism. So Willa and

11:54

more than 70 of her colleagues have published

11:56

a detailed response to the Institute's report questioning

11:59

the reliability of the drug. of its sources and

12:01

saying it misrepresented aspects of the trial. I

12:03

think a lot of us were just sort

12:06

of shocked at sort of the gossipy kind

12:08

of hearsay nature of the report. We are

12:10

all therapists that are invested in finding new

12:12

tools to help our patients. That is true,

12:14

but we also want to do it safely.

12:17

Willa told me therapists meticulously

12:19

detailed any adverse events, sessions

12:21

were recorded, and to

12:23

protect against bias, data from participants about

12:26

their PTSD symptoms were collected online by

12:28

people who did not know whether

12:30

the person had taken MDMA or a

12:32

placebo. I also spoke with

12:35

Jennifer Mitchell at the University of California,

12:37

San Francisco. She was the lead author

12:39

of the published findings from the trials.

12:41

I didn't feel any pressure from the

12:43

sponsor to come up with anything different than

12:45

what the data was providing. I didn't feel

12:47

that at all and wouldn't have continued to

12:49

work with him if I had felt that.

12:52

Jennifer did acknowledge she doesn't know what

12:54

happened every day at each trial site

12:57

around the world, but she points out

12:59

the FDA is closely involved in the

13:01

trials and has access to all

13:03

the data. Well, okay.

13:06

So this is where we're at

13:08

right now. You have the FDA

13:10

weighing LIGO's application for MDMA-assisted therapy

13:13

with conflicting views on the quality of

13:15

their data. So what's next? So

13:18

what's next is that tomorrow a panel of

13:20

advisors will discuss the data, and then there

13:22

will be an opportunity for public comment for

13:24

an hour and 40 minutes. Spicy.

13:27

That is a lot of public comment.

13:30

One of the people I expect will

13:32

speak up is Nishe Devano. She's

13:35

a lecturer in the writing program at

13:37

Johns Hopkins and studies psychedelics. She

13:40

and a group of others who've been involved

13:42

in the psychedelic field over the years actually

13:44

petitioned the FDA to hold this public meeting.

13:47

They point to the report I

13:49

was talking about, and they brought

13:51

up even more troubling allegations. They

13:54

say it's possible the data was

13:56

manipulated, that certain adverse events may have

13:58

been overlooked or not reported. And

14:00

to back this up, they cite an

14:02

anonymous former employee of Lycos. Here's

14:05

why Nishe felt like she needed to speak

14:08

up. Because I think that there is

14:10

a lot of potential for MDMA, but

14:12

I think that the research has to

14:14

be done properly or else

14:16

the rollout could harm

14:19

a lot of people potentially. Okay. Well,

14:21

I mean, where is the rollout right now

14:24

with this drug? So the FDA has

14:26

actually fast-tracked the drug application and says

14:28

it plans to make a decision by

14:31

early August. Okay. Now, a

14:33

spokesperson for Lycos said to me they

14:35

fully support holding the public hearing. And

14:37

I would just say overall, Emily, this is

14:39

building up to be a pretty high profile

14:42

moment for the psychedelic movement. There

14:44

is a lot of money riding on this

14:46

treatment and the possibility of approval. And

14:48

if that is derailed, it will mean

14:51

that those living with PTSD who want

14:53

a new treatment will have to keep waiting.

14:55

Well, we will keep an eye on how it goes. Thank

14:58

you for bringing us this reporting, Will

15:00

Stone from NPR Science News. Thank you. This

15:04

episode was produced by Burleigh McCoy. It

15:06

was edited by Amna Khan and back-checked by Will.

15:09

Josh Newell was an audio engineer. I

15:12

am Emily Kwong. Thank you for listening

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