This Week in Psychedelics: UK gets its first commercial clinical trial facility, 17 arrested at DEA protest, and critiquing the critique

Plus: Telehealth practices under DOJ and the black box of psychedelic treatment

Happy Friday, and welcome back to The Microdose. Here’s the news of the week:

Telehealth practices under DOJ investigation. Mental health start-up Cerebral is under investigation by the Department of Justice for potential violations of the Controlled Substances Act, Business Insider reported last week. Cerebral provides therapy for people with mental health conditions like anxiety, depression, and ADHD, as well as prescriptions for medications like Adderall and Xanax to treat those conditions. Days before Business Insider’s reporting was published, a former Cerebral executive filed a lawsuit alleging that the company had overprescribed stimulants to patients with ADHD. 

What happens to Cerebral could have reverberations in the psychedelics world — currently, many providers are offering mail-order ketamine to patients. “The federal government may be paying close attention to controlled substance telehealth providers,” writes Griffen Thorne in the Harris Bricken Psychedelics Law Blog. And, Thorne points out, if the government phases out its COVID-19 protocols, telehealth prescriptions may not remain legal for much longer. Under normal circumstances, physicians can only prescribe medication after an in-person evaluation, but during the pandemic, providers could do so virtually.

17 arrested at DEA protest. On Monday, protesters gathered in front of the U.S. Drug Enforcement Administration’s headquarters in Arlington, Virginia to demand that the agency allow terminally ill patients to access psilocybin-assisted therapy. (Read The Microdose’s 5 Questions for Erinn Baldeschwiler to learn more about one of the patients at the center of this effort and her attempts to access psychedelic treatment.) 

According to the activists’ Facebook page called Right To Try Psilocybin, about two dozen people attended the protest. In a nearly 4-hour live video, they documented the day’s events, which included speeches; drawing hearts and writing in paint on the DEA building’s windows (“STOP IGNORING DYING AMERICANS,” read one message); and staging a “die-in” at the building’s entrance. The Hill reported that 17 protesters were arrested during the die-in and charged with trespassing. Right To Try Psilocybin posted an image of those arrested, triumphantly holding their summons papers and zip-tie handcuffs; among those arrested was Baldeschwiler, a terminally ill cancer patient seeking psilocybin-assisted therapy. 

“Continued denial, resistance and obstruction of the law of land serves no one, and in fact serves to force patients and veterans underground or out of this country to seek relief that is so desperately needed,” Baldeschwiler told The Microdose. “Even the police officers on the scene tried everything to negotiate talks between myself and the DEA, to no avail. The officer who took me into custody said they all ‘felt bad and did not want to arrest us.’”

via Right To Try’s Facebook page

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Critiquing the critique. Last week, we reported on a pre-print paper by Johns Hopkins researchers Manoj Doss and Fred Barrett, and Yale researcher Phil Corlett, which detailed concerns about a recent Nature Medicine study. This week, three of the researchers who published that Nature Medicine paper — University of California at San Francisco’s Robin Carhart-Harris, and Imperial College London’s Richard Daws and David Nutt — wrote a response to the Doss et al. paper, and uploaded it to the pre-print server PsyArXiv (Pre-prints are papers that have not yet been peer reviewed.) 

In the document, the authors counter some of the methodological concerns Doss, Barrett, and Corlett raised. Carhart-Harris et al. explain how they came to use certain measures and analyses. In some cases, they say, alternative statistical analyses would not have substantively changed their results; in others, they defend their methodology, saying their choices were appropriate for their hypothesis. 

While lively, lengthy methodological debates are not uncommon in academic circles, two things stand out about this rebuttal. The first is the pointed accusations; in several places, Carhart-Harris et al. refer to the critiques in Doss et al.’s paper as misleading or as misinformation, and they imply that Doss et al. might have “felt motivated to disseminate a strongly worded critique of our Nature Medicine paper” because one of Doss’s recent papers had not been cited in the Nature Medicine article. 

The Carhart-Harris et al. paper also shows how common it has become for scientific discourse to happen outside traditional academic venues. Publishing a paper in a peer-reviewed journal can often take months, if not years, and other debates between academics generally take place through private correspondence (or maybe over a beer at an annual conference). Now, the public can follow along in real time as researchers take their criticisms straight to social media and upload their papers to pre-print repositories like PsyArXiv. In fact, Carhart-Harris et al.’s paper mentions at least two exchanges that happened via Twitter, and hours after the paper was posted, Carhart-Harris, Corlett, and other researchers have tweeted their thoughts and reactions.

This is far from the last debate we’ll see about study design and analysis in psychedelic science. Some of those questions might involve methodological issues like the ones detailed in this back and forth between Carhart et al. and Doss et al., like what kinds of tasks are appropriate for participants as they lie in fMRI scanners. (Doss et al. argue letting people lie in the scanner without a task could create ambiguity in results — i.e., could people be sleeping? — but Carhart et al. say there are ways to control for this ambiguity.) Other big questions include how to properly “blind” clinical trial participants, whether previous psychedelic experiences might change participants’ reactions, how to standardize setting, and whether it’s possible to standardize psychotherapy methods. 

The UK gets its first commercial clinical trial facility. British start-up Clerkenwell Health has just announced it will begin psilocybin clinical trials in London this August. Clerkenwell’s facility will be Europe’s first commercial psychedelic research clinic, and the company will partner with North American pharma companies like Psyence, Mindset Pharma, and Mydecine to develop new trials, according to The Guardian. Research institutions like Imperial College London have been leaders in conducting such clinical trials, but we’re now seeing more companies in the UK (and beyond) pouring resources into clinical research. As Imperial College London’s David Nutt told The Guardian: “There is clearly a need to facilitate clinical trials with psychedelic drugs beyond the very few academic centers currently doing this research. So I welcome an external organization developing the necessary skills and expertise to support companies wanting to invest in these treatments.”

The “black box” of psychedelic treatment. Standardizing the treatment participants receive in clinical trials can be difficult — and according to a new story published in New York Magazine’s The Cut, participants in MAPS’ MDMA clinical trials might have received markedly different experiences. A 2017 training manual for MAPS therapists includes allowances for different interventions, including holotropic breathwork, a type of rapid breathing which can induce altered states. 

While it’s impossible for participants to receive identical treatment, variability in interventions makes it hard to identify which aspects of treatment are driving study effects. It could also be confusing to participants. “An experimental method that allows so much variability puts greater power in the therapists’ hands,” write Lily Kay Ross and David Nickles, co-hosts of the podcast Power Trip, who go on to suggest that “a limited public understanding of what the psychotherapy is supposed to look like increases the risk of abuse." 

• Psychedelics advocates have raised concerns about bad psychedelic patents. “Perhaps this shouldn’t come as a surprise, not because of psychedelics, but because of the problems with the patent system as a whole,” Shayla Love writes for VICE. 

• CORRECTION: Last week, we linked to a VICE piece on Chris Cantelmo, a biochemist turned DMT evangelist who led a pseudo-cult on Reddit. We misstated the author of that piece; it was written by Nick Thompson. We regret the error.

You’re all caught up! Have a great weekend. Stay tuned for a new 5 Questions on Monday.

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