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Thank you, New York Times, for asking ‘Who is behind these studies? Where does the money come from?’

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4 Star

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Ecstasy as PTSD Relief for Soldiers: ‘I Was Able to Forgive Myself’

Our Review Summary

The study highlighted in this well-written article adds to a growing body of research into whether using the synthetic, psychoactive drug MDMA  (street names “Ecstasy” or “Molly”) in conjunction with psychotherapy, can improve outcomes in PTSD.

The article makes effective use of a question-and-answer format to discuss previous research in this area, the risk that such research might encourage DIY treatments, as well as the potential harms and benefits of an approach that’s recently been granted breakthrough therapy status by the FDA.

Of note, we thought the issue of funding — usually ignored in about 70% of the stories we review — was handled in a very comprehensive and compelling way.

 

Why This Matters

The National Institute of Mental Health (NIMH) estimates the lifetime prevalence of PTSD to be about 7%. The duration and severity can vary widely, and successful treatment is a challenge.

MDMA and psychotherapy to treat PTSD is just one example of an emerging area in psychiatry: Using non-FDA-approved psychoactive drugs (including LSD or hallucinogenic mushrooms), in conjunction with therapy, to treat everything from chronic pain to major depression.

It’s a paradigm shift, to say the least, which means this type of research will undoubtedly generate substantial news coverage. Exercising caution and restraint — as this New York Times article did — will likely be more the exception than the rule.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The cost of MDMA is not mentioned, and likely difficult to forecast.

However, the associated therapy is fairly intensive, and it remains to be seen if it would be covered by insurance. Still, a discussion of these potentially significant costs would have been relevant and helpful, even if the story admits they’re largely unknown.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

We’re told that after two sessions of MDMA-assisted psychotherapy …

… a majority of 26 combat veterans and first-responders with chronic PTSD (who had not been helped by traditional methods) saw dramatic decreases in symptoms. The improvements were so dramatic that 68 percent of the patients no longer met the criteria for PTSD. Patients taking the drug also experienced “drastic” improvements in sleep and become more conscientious, according to the study.

This is enough to rate Satisfactory, but we think the story needed more details on how the study was designed to help readers understand this result (see evidence quality, below).

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The article states:

Side effects including anxiety, headache, fatigue, muscle tension, and insomnia, were generally minor and limited to the days following the MDMA sessions.

Readers might have concerns regarding the long-term consequences of pharmaceutical grade MDMA, but this is unknown. The article does make it clear that the MDMA-assisted psychotherapy model used in the study only involves taking the drug on 2-3 occasions.

Also, the article anticipates that some people may (and already do) turn to street sources of MDMA (aka “Ecstasy” or “Molly”) to self medicate. It’s made clear that this could could be dangerous, or even fatal, since street sources can be laced with other psychoactive drugs.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

In an otherwise comprehensive article, there’s room for improvement here.

We’re told a limited amount about the study design; in particular the questionnaire (called “CAPS-IV”) used to measure response in this small group of people. So we have little context with which to understand this outcome: Roughly 2 out of 3 subjects no longer meeting the criteria for PTSD.

Also, there’s the issue of the reliability and reproducibility of questionnaires that rely upon the self-reporting of symptoms.

Having said that, the article does well to ask: But does it actually work?

Large-scale trials, which will include up to 300 participants at 14 sites, may not be able to replicate the success of previous trials, which were limited to a few dozen patients.

Lastly, in an editorial that ran in the same issue of the Lancet, the editorialists also make the point that the participants were recruited via the internet and word of mouth, potentially skewing towards those “keen” on trying ecstasy.

Does the story commit disease-mongering?

Satisfactory

None. PTSD is fairly common and moderate to severe cases often prove difficult to treat.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The unique funding for this project, as well as “who cashes in if MDMA becomes legal” is thoroughly covered and a very nice addition to the article.

The lead authors appear to have no financial conflicts of interest, and multiple sources were tapped.

Does the story compare the new approach with existing alternatives?

Satisfactory

The answer is revealing; essentially current interventions — mostly psychotherapy and/or drugs — have been mostly ineffective.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

It’s made clear that MDMA “is about to enter larger Phase III trials,” the FDA has granted pharmaceutical grade MDMA breakthrough therapy status, and that illegal sources exist but are potentially dangerous.

It’s also mentioned that there have already been several other small-scale studies of the drug, and that if MDMA is eventually approved by the FDA it will only be administered by a licensed therapist.

We did have one quibble–the story predicts that, if larger studies go well, the drug could be approved for this use “by 2021.” In reality, there’s really no way of knowing what year a drug will get approved.

Does the story establish the true novelty of the approach?

Satisfactory

In the section “Is MDMA therapy new?” we learn that MDMA-assisted psychotherapy has been both formally, and informally, used in the past.

Total Score: 8 of 10 Satisfactory

Comments (1)

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Shawn 'AMKR' Dickinson

May 11, 2018 at 1:08 am

I must say as someone with cPTSD (Complex PTSD) an occasional psychedelic (lsd, mdma, mescaline, DMT, mushrooms, medical marijuana” trip (only when I feel it’s needed with mediation and yoga, it is like ten years of therapy to me, but to each there own. – everyone’s physiology is different!

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