Post-traumatic stress disorder is difficult to treat. Over the course of the past decade, evidence has been accumulating that the compound 3,4-methylenedioxymethamphetamine (MDMA), better known as ecstasy, may be more effective than current drugs such as Zoloft and Paxil.
This story, jump-started by a recent decision by the Food and Drug Administration to classify MDMA as a “breakthrough drug,” which allows it to be evaluated and possibly approved more quickly, offers the reader a well-written account of the evolution of MDMA from a bad actor to a potentially efficacious one.
An important element of the narrative is the dominant role of a nonprofit organization, the Multidisciplinary Association for Psychedelic Studies, which is dedicated to ending government bans on psychedelic substances and marijuana and has funded virtually all of the extant research on MDMA’s impact on PTSD sufferers. While the story is well-sourced, the text fails to explore this conflict of interest. It also may land too heavily on the side of “probable” rather than “possible.”
The headline—Ecstasy could be “breakthrough” therapy for soldiers, others suffering from PTSD—is worded conditionally but clearly heralds the dawn of a new age.
Given the long clinical trial road ahead, despite MDMA’s “breakthrough” status designation, much could change.
The substance MDMA may meet all evidentiary challenges and emerge at some point in the future as an effective part of the treatment regimen for PTSD. But drumming up enthusiasm for the drug before it is officially available, as this story may do, runs the risk of sending PTSD sufferers to a less safe—and certainly illegal—form: Ecstasy.
Cost is not discussed. Since the drug of interest—MDMA—is banned in the US as a Schedule 1 substance, cost estimates may be unreliable. But that doesn’t make some mention of cost irrelevant here. And since the drug is given along with intensive therapy, that cost also could have been discussed.
The story briefly describes the results of one clinical trial, which found that slightly more than half of the 107 participants reported major reductions in PTSD symptoms. But this isn’t enough to understand the benefits.
The story explained this but could have emphasized it more: The drug is proposed for use as part of an intensive therapy program, with doses of it given just a few times and with professional supervision–and not daily or chronically, as many drugs for psychiatric conditions are administered.
Harms do get acknowledged, albeit rather low in the story.
The story identifies existing studies as “clinical trials” but offers little explanation of what that means. More emphasis on the nature and quality of evidence would be an important addition here. We don’t know if they are randomized or controlled, nor peer reviewed, nor what the limitations are, etc.
Recent and ongoing military conflicts overseas have dramatically increased the numbers of PTSD sufferers returning to the U.S., and, one independent source notes, existing drug treatments fail two thirds of those patients.
One interesting thing to note on measuring how common it is: For U.S. soldiers, those with PTSD in our military get disability payments for the rest of their lives. Rates of PTSD are much less frequent in ex-British soldiers who served in the same places, and they don’t have the generous compensation system we do.
We rate this a just-passing “Satisfactory.” The story could have been more overt about the funding support of an organization dedicated to ending the US government’s ban on psychedelics. A careful read of the text will allow the reader to infer that the group—the Multidisciplinary Association for Psychedelic Studies, or MAPS—is funding the clinical trials on which an FDA assessment of MDMA’s efficacy will be based.
But a more overt description of that causal chain would have been helpful, as MAPS has a clear agenda. Sources and their relationship (or lack thereof) to MAPS are clearly delineated, and the story does offer contrasting views on the safety of MDMA. But it will be hard for the reader to determine where the bulk of experts sits on this issue.
Drugs such as Zoloft and Paxil are mentioned, along with more traditional talk therapy. All are deemed seriously flawed.
This is sufficient, but more could have been said about cognitive and exposure treatments, too.
The text is clear that the FDA has not yet approved the use of MDMA and that large-scale clinical trials must be conducted before a federal evaluation will take place. But the street version of the substance, called Ecstasy, is, of course, widespread. The story cautions that the street drug often contains harmful contaminants so should not be used in place of MDMA, but one wonders how hard it may be for someone desperate for a way to moderate PTSD symptoms to wait.
Small clinical studies of the impact of MDMA on PTSD sufferers have been under way for a number of years, and journalists have been writing about that possible link along the way. The hook for this story is really the recent FDA classification of MDMA as a “breakthrough therapy,” which puts it on a faster track for review (and often a lower bar of evidence is required).
This appears to be an intensively reported enterprise story that goes well beyond a MAPS news release.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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