MICHEL MARTIN, host:
I'm Michel Martin, and this is TELL ME MORE from NPR News.
Just ahead: the virtue of celibacy. She is a doctor and a minister, and she says she is a virgin and proud of it. We will let her tell you all about it. That's next.
But first, in the 1960s, LSD was touted as a potential wonder drug for the treatment of psychiatric disorders. But in the tune-in, turn on, dropout days of a counterculture era, it was also abused, and the U.S. government outlawed it in 1971. For two decades, there was an almost total ban on medical experimentation with hallucinogenic drugs. But those restrictions are beginning to loosen, and researchers are starting to look at uses for the drug MDMA. It's better known on the streets and nightclubs as ecstasy. An FDA-approved study is currently investigating whether MDMA could be effective in treating people suffering from post-traumatic stress disorder.
In this week's Washington Post Magazine, author Tom Shroder talks about that study in his story, "The Peace Drug." Shroder is editor of the magazine. He's here with us in the studio.
Also joining us is Dr. Michael Mithoefer, who conducted the experiments. He is at ARP studios in Charleston, South Carolina.
Welcome to both of you, gentlemen.
Dr. MICHAEL MITHOEFER (Associate Clinical Professor of Surgery, Columbia University College of Physicians and Surgeons): Well, thank you. Glad to be here.
Mr. TOM SHRODER (Editor, Washington Post Magazine): Thank you. Nice to be here.
MARTIN: Tom, how did you get interested in this subject?
Mr. SHRODER: Oh, I actually knew Rick Doblin, who is the man behind the funding of many of these studies, with an organization called the Multidisciplinary Association for Psychedelic Studies. I knew him when I was a college student, and I've followed his career since that time.
MARTIN: And - so Dr. Mithoefer, how - what gave you the idea to use MDMA to treat post-traumatic stress disorder? What is it about that drug that gave you the idea that it could be helpful? And how does it work?
Dr. MITHOEFER: Well, I treated a lot of people with post-traumatic stress disorder, and I was aware of the anecdotal reports from the period when MDMA was actually a legal substance. A number of therapists used it, and although no controlled trials were done, they reported on the effects. And, you know, our hypothesis is that since fear and defensiveness are part of PTSD - post-traumatic stress disorder - then they can also be obstacles to the treatment, because treatment involves revisiting the trauma in therapy. So the idea is that if this is a drug that could help reduce of levels of fear and defensiveness and allow people to then revisit the trauma in a therapeutic way, that it could be helpful. And these are people who are resistant to treatment. All of our subjects have had treatment with both medications and therapy in the past, and still have very significant PTSD symptoms.
MARTIN: Are there any other effective treatments for PTSD? Or are these…
Dr. MITHOEFER: There are.
MARTIN: …patients just so in such distress that just - the conventional treatments aren't working?
Dr. MITHOEFER: Right. There are a number of effective treatments: exposure therapy, cognitive behavior therapy, EMDR, other talking therapies, and they can be very effective for some people. But there's a significant number of people who are still not helped by those treatments.
MARTIN: Now, you, as a former emergency room doctor, I would have to assume you've seen the effects of MDMA, or ecstasy, being abused. So did you have any concern starting these trials, that this just might not be worth it?
Dr. MITHOEFER: Well, yes…
MARTIN: Might do more harm than good, I guess.
Dr. MITHOEFER: Right. That's always an important consideration. It's a matter of weighing the risk versus the possible benefits, and we looked at that very carefully. And while there's still unanswered questions about recreational use and there's no question that MDMA can be dangerous in some situations, there's quite a bit of phase one safety data from studies in the United States and Europe using doses similar to the ones we're using under medical supervision -pure MDMA - that have shown that can be safely administered in that kind of situation.
MARTIN: Tom Shroder, for many years, the federal government's refused to allow even the study of therapeutic uses of so-called psychedelic drugs. Why did that ban start, and why is it starting to change?
Mr. SHRODER: Well, I think it started because of the, really, with Timothy Leary, who began the scientific study of psychedelic drugs and then turned into a cheerleader for the widespread abuse of it, I think that scared a lot of people. And it also became associated with a counterculture that was also frightening to the establishment, so I think there was a political element, as well. And clearly, there are many more drugs that are even more dangerous than these that are used for medical purposes all the time.
So I do think that the extent of the prohibition is partly - has a political dimension to it, and I just think that a lot of patient work by a lot of people who believed in the potential of these drugs over many years has finally yielded some results with scientific studies that, as Dr. Mithoefer showed, said that in the small doses in clinical situations, that this certainly was not as dangerous as many drugs that have a very important medical use.
MARTIN: But you've also point out in the article that some of the other people who've gotten interested in this subject from a research perspective become - well, how can I put it? Get a little too close to the subject, maybe, for comfort. They just become advocates in a way that seems to detract from people's willingness to accept some of the science. I just wonder why that is. I mean, Rick Doblin is a person you met who's very…
Mr. SHRODER: Well, Rick Doblin - right, right. Rick Doblin…
MARTIN: …he's very excited about the government policy related to illegal drugs and…
Mr. SHRODER: And he also has a libertarian element, in his viewpoint that the government shouldn't control what people choose to do with their bodies. But again, he has a scientific - he agrees with Dr. Mithoefer that if MDMA was ever going to prove its effectiveness, that even then it should only be used in specialized clinics. And Dr. Mithoefer can speak to this with trained clinicians who are trained in administering this therapy.
MARTIN: Dr. Mithoefer, can - talk to me about what you've found so far. How has this drug worked with the patients that you've worked with so far? How do the benefits last, and is addiction a problem?
Dr. MITHOEFER: Well, I want to emphasize, first of all, that this is just preliminary data. This is a small pilot study, and we haven't even finished this study yet. So we realize that there - we have a long way to go before we prove anything about effectiveness. But what I can say is that preliminary data is encouraging, and these people who have failed other treatments were seeing significant decreases in their scores of PTSD symptoms measured by objective measures in many of the people.
MARTIN: And is addiction a problem? Is it an issue? Or I guess they're just not, they're not on - first of all, they're so closely monitored, and secondly, they're not on it long enough for that to manifest itself if that were a possibility. Is that it?
Dr. MITHOEFER: Well, right. One important point is we don't give people MDMA every day or any MDMA to take home. They only receive it the maximum of three times under our direct supervision with a male and female therapist present, and so there's no potential for misusing the MDMA we're giving them. And what we've seen is people at the end of this study tend to have the feeling that, you know, this is a serious thing that's - they're - they've been introduced to, usually, and most people have not taken it before. They've experienced it in a medical setting, and they were not seeing people having the inclination to go out and take it on their own and use it.
MARTIN: So what's next? What happens next? You've completed the first year phase of the clinical trial. What's next?
Dr. MITHOEFER: Yeah, this is phase two. We need to finish the study, which will happen this fall - I mean, this coming summer. And then, we're looking at moving on to larger phase three trials, which would be in multi centers, and involving many more subjects. And those larger trials have been in position to statistically show whether or not this is an effective treatment.
MARTIN: Tom Shroder, a final question to you, just about a minute left here. Do you feel that sort of overall, the context in which we discuss treatments for drug addiction where alcohol or whatever drug is changing, or is this just kind of a happy accident that the seriousness of PTSD as such that the public health demand - particularly given all the soldiers coming back from Iraq and Afghanistan - is such that there's a willingness to bend the rules in this particular way? Or is something larger changing in our society and the way we think about the uses of drugs?
Mr. SHRODER: Well, I actually don't think it's bending any rules. I think the FDA deserves some credit here for saying, well, we're going to look at this. And if there's good science that shows this is an effective treatment, then we're going to proceed as we would with any other potentially helpful drug.
MARTIN: But it has required a change in perception, a change in attitude in order to get to this point. And I'm wondering whether you think there's a broader shift in attitude taking place, or is this just that the system is correcting itself in going back to the science?
Mr. SHRODER: Yeah, I think that that is actually the way to look at it, is these drugs always had potential, and they had - they just flat out banned anybody from looking at it for a generation, and now that is going away. And I think there's going to be a lot more serious examination of the potential of these drugs for helpful medical use.
MARTIN: Tom Shroder is editor of the Washington Post Magazine. He's author of this week's story, "The Peace Drug."
We were also joined by Dr. Michael Mithoefer. He's a psychiatrist and researcher in Charleston, South Carolina.
You can read the article in its entirety by visiting our Web site, npr.org/tellmemore.
Gentlemen, thanks so much for speaking with us.
Mr. SHRODER: Thank you, Michel.
Dr. MITHOEFER: You're welcome. Thank you.
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