After pushing paper after paper into the public, activists have succeeded in getting the world to pay attention to psychedelics research again. But now that everyone is looking, revelations are coming out that the world of psychedelics research is not as warm and cozy as it seems on the surface.
Footage showing a patient in an MDMA (3,4-Methylenedioxymethamphetamine) study being inappropriately touched, blindfolded, and pinned down by two therapists during a clinical trial conducted by the Multidisciplinary Association for Psychedelic Science (MAPS) has put psychedelics research in the spotlight. After one of the therapists was accused of sexually assaulting the patient outside of the clinic, as of 2018, the therapists in the footage are no longer associated with MAPS. However, even after it was known the therapist had engaged in inappropriate behavior, MAPS neglected to review the footage taken during the trial until six years later.
This has led to all Health Canada approved MDMA trials being halted for review. Following the release of the footage, multiple other participants have come forward with negative experiences that were not included as adverse effects by the group, and mishandlings of data representation in publications have been pointed out in a complaint to the federal agency by fellow researchers.
This comes at a time being hailed as the “psychedelics renaissance” as an explosion of exemptions are being granted for psychedelics research, and promising studies are coming out. One study showed psilocybin helped 40 out of 51 patients with life-threatening cancer (and no prior beliefs in psilocybin as a miracle drug) reduce their depressive and anxiety levels by over 50%, for up to 6 months with just a single dose. [1] Another study found a 5-HT2A agonist, similar to lysergic acid diethylamide (LSD), caused epigenetic modifications that promoted the formation of cell growth proteins in mice which might explain the increased neuronal growth that has been associated with psychedelic drugs. [2,3]
It’s easy for us to look at these results and brush off those who criticize the work being done as having a lingering bias from the war on drugs. But it is more than that. In addition to association with counter-cultural movements in the 1960s, accusations of sexual violations against patients were also cited as one of the reasons to halt research. [4]
With the revelation that MAPS has been leaving out data that does not support their hypotheses, and pooling results from different experiments with different controls, methods, and numbers of participants as low as four patients, it’s also understandable why some don’t trust that the results for treatment are as promising as some researchers claim. Many participants came forward noting that, over the course of treatment, they developed increasing suicidal thoughts that were never listed as adverse events in the literature.
Psychedelics research is seeking the same acceptance as any other form of medical research, but recent trials are lacking stringent protocols that others must follow. In British Columbia, where the trial was taking place, anyone can call themselves a counselor or therapist (that is, they can be unlicensed and not be under any governing body). And anybody who is called a counselor or therapist can apply to work for MAPS with patients under the influence of psychedelics. So basically, you don’t need any qualifications to apply to work in these trials. Compare that to many clinical trials in British Columbia that require members to have at least a degree in a relevant field (usually more), several years of experience, and a clean criminal record. Negative adverse side effects must be documented. And publications will often note all the weaknesses of the study and how they can improve next time.
Every scientist needs to work against their bias to only include positive results (or to slant their results to sound more promising). This is especially true in a field where many of the researchers are open about believing in (and even using) the drugs they are researching. For example, an article by Dr. Cahart-Harris reported that, in his study, 33% of participants in the control group had a clinically significant reduction in depressive symptoms, which heavily contrasted the 70% in the psilocybin test group. However, in the original, peer-reviewed article, 48% of the control group had a clinically significant response, no p-values were included to show the probability of the results happening by chance, and there was a note that “no clinical conclusions can be drawn from these data”. [5]
Practitioners have noted some questionable practices and a flexibility of boundaries in psychedelics therapy that would normally not be acceptable with talk therapy. [4] This includes encouraging the use of “nurturing touch” on participants while they are undergoing therapy, and approaching patients on an “equal footing” which has included therapists sharing their own experiences and making themselves available to patients outside of the clinic. Some therapists were also encouraged to experiment with the drug to gain insight. These things might make some participants feel more welcome, but they also put them at risk of being touched when they are unable to give consent. The level of individualistic makes it difficult to know how much the reduction of depressive symptoms is due to the drug, and it also makes it difficult to pool the experiences of patients when they are each having such different experiences. In some cases, it has led to patients becoming overly dependent on their therapists and seeing them as a friend, which led to distress when the treatment suddenly ended.
This trend of only reporting the good, flexible boundaries, and constant references to the “natural,” “spiritual,” and “traditional” use of the drug is reminiscent of the spiritual healing and free love practices of the early psychedelics movement. Which leads one to ask — what are we trying to accomplish with psychedelics trials? Do we miss the 60’s and we are looking for a hit of nostalgia? Or are we trying to gain legitimacy in the scientific and medical community as a whole?
MAPS has put out a statement addressing their shortcomings, clarifying certain therapists have greatly deviated from what was acceptable, outlining their plans to improve, and encouraging other researchers to also do some self-reflection.
As critical supporters of psychedelics research, we couldn’t agree more with their last statement. If the goal is to gain legitimacy in the research community, all psychedelics researchers should consider how they can ensure the safety of patients in clinical trials, the accurate representation of data, and requirements that guarantee that only the most qualified professionals are being trusted to care for someone under the influence of psychedelics. Let’s stop downplaying risks that come with psychedelics. Sure, taking psychedelics once won’t burn holes in our brain the way we were told in high school, but they can cause hallucinogen persisting perception disorder, have increased suicidal thoughts of some trial participants, and are known to change the regulation of pathways in the brain we do not yet fully understand. [6,7]
As scientists, we can’t try to hide away our dirty secrets or cut corners, because we will get found out, and when we do, it will lead people to ask, “why did you hide this, and what else are you hiding?” There have been some fantastic contributions to psychedelics research that bring legitimacy to the field. We don’t want to give ammunition to governing bodies a few years down the line who may be looking for an excuse to halt all research. We need to be willing to look critically at our own work. We can’t be going into a study with the main goal to prove ourselves right by any means necessary. We need a goldilocks approach, as Anderson Petranker et al. note, “[h]igh-quality psychedelic[s] research must protect itself from both overzealous institutional safety concerns and from private interests that wish to skirt regulation in favor of fast results or market advantage.” [8]
References:
[1] Griffiths RR, Johnson MW, Carducci MA, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016;30(12):1181-1197. [journal impact factor = 4.153; times cited = 686][2] de la Fuente Revenga M, Zhu B, Guevara CA, et al. Prolonged epigenomic and synaptic plasticity alterations following single exposure to a psychedelic in mice. Cell Rep. 2021;37(3):109836. [journal impact factor = 9.423; times cited = 8]
[3] Shao LX, Liao C, Gregg I, et al. Psilocybin induces rapid and persistent growth of dendritic spines in frontal cortex in vivo. Neuron. 2021;109(16):2535-2544.e4. [journal impact factor = 17.17; times cited = 17]
[4] Brennan W, Jackson MA, MacLean K, Ponterotto JG. A qualitative exploration of relational ethical challenges and practices in psychedelic healing. Journal of Humanistic Psychology. September 2021. [journal impact factor = 2.039; times cited = 1]
[5] Carhart-Harris R, Girabaldi B, Watts R, Baker-Jones M, Murphy-Beiner A, et al. Trial of psilocybin versus escitalopram for depression. N Engl J Med. 2021;384:1402-1411 [journal impact factor = 91.24; times cited = 106]
[6] Aleksandrova LR, Phillips AG. Neuroplasticity as a convergent mechanism of ketamine and classical psychedelics. Trends Pharmacol Sci. 2021;42(11):929-942. [journal impact factor = 9.93; times cited = 7]
[7] Cormier Z. No link found between psychedelics and psychosis. Nature. 2015. doi:10.1038/nature.2015.16968. [journal impact factor = 49.96; times cited = 2]
[8] Petranker R, Anderson T, Farb N. Psychedelic research and the need for transparency: Polishing Alice’s looking glass. Front Psychol. 2020;11:1681. [journal impact factor = 2.99; times cited = 7]
