Bipartisan Breakthrough Therapies Act, NIMH lays out psychedelic research priorities, and grappling with a “bad trip”
Plus: Ayahuasca’s adverse effects, and new details on why the UK rejected Spravato
Happy Friday, and welcome back to The Microdose.
Bipartisan Breakthrough Therapies Act
Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced the Breakthrough Therapies Act, a bill that proposes amendments to the Controlled Substances Act which would relax some requirements for researchers studying psychedelics. It would also require the Drug Enforcement Agency to transfer Schedule I drugs that the FDA has designated as “breakthrough therapies” (i.e., psilocybin and MDMA) to Schedule II. That rescheduling could “help facilitate a phased roll-out of these potentially lifesaving therapies via FDA-approved Expanded Access pilot programs,” Booker’s team wrote in a press release. The bill has been referred to the Senate’s Committee on the Judiciary.
NIMH lays out psychedelic research priorities
The U.S. National Institute of Mental Health issued a notice detailing the agency’s “priorities and considerations” for psychedelic drug research. “Grant applications proposing to use animals as model systems to study brain mechanisms of psychedelic action should take into consideration that animal systems are not well suited to assess the therapeutic efficacy of psychedelics,” the NIMH says. As a result, the agency says it places a low priority on studies that use animal models in studies of mental illness or research evaluating the efficacy of psychedelics compared to antidepressants. Studies must make a clear link between how animal models map onto human neurobiology and behavior.
The NIMH also says it places a low priority on studies that “lack rigorous and reproducible assessment” for blinding patients, therapists, and raters. Additionally, to receive NIMH support, studies should account for “expectancy effects,” or how researchers’ and participants’ expectations can affect study outcomes. Over the last few years, scientists have raised concerns about a lack of blinding and accounting for expectancy effects in psychedelics studies.
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Grappling with a “bad trip”
In the Harvard Divinity Bulletin, second-year master of divinity student Rachael Petersen writes about what happened to her after taking a high-dose of psilocybin as part of a clinical research trial to treat major depression. She experienced anxiety, dread, and persistent insomnia that tormented her for months.
Petersen calls for more nuance in the ways we talk about “bad” trips, and her experience shows how even in highly controlled clinical trials with guides and carefully monitored drug doses, participants may experience serious distress. “Amid growing hype that psychedelics are a panacea for mental illness, I worry: Is my partial testimony being co-opted to support a medicalization effort I increasingly doubt can fully attend to the weird wildness of these medicines?” she writes.
Ayahuasca’s adverse effects
In a study of more than 10,800 ayahuasca users, around 70 percent reported adverse physical effects, and 56 percent said they experienced adverse mental health effects. However, most effects were mild; the majority of participants who reported physical effects experienced vomiting and nausea, and the most common mental health effects were anxiety and hallucinations.
The research, published in PLOS Global Public Health, sought to understand the prevalence of side effects. “Although researchers have been conducting clinical trials and observational studies reporting medical and psychological benefits, most of these do not report ayahuasca’s immediate or medium-term adverse effects, so these are underrepresented in the literature,” the authors write. “With the expansion of ayahuasca ceremonies from their traditional contents to countries around the world, there is an important public health question regarding the risk/benefit balance of its use.”
The study was conducted in six languages and included data from participants in 50 countries. While the majority of participants reported adverse physical and mental health effects, a very small proportion of participants (2.3 percent) sought medical attention for the physical effects they experienced, but a higher proportion of participants — around 12 percent — sought professional support for the mental health effects they experienced. However, 88 percent of participants who reported adverse mental health effects said they believed those effects were part of a positive process of growth or integration. “Ayahuasca practices can hardly be assessed with the same parameters used for prescription medicines, since the myriad of its effects include challenging experiences that are intrinsic to the experience, some of which are considered as part of its healing process,” the authors conclude.
New details on why the UK rejected Spravato
The UK’s National Institute for Health and Care Excellence (NICE) released a document detailing why the government agency decided not to recommend the esketamine spray Spravato to treat major depressive disorder. (Esketamine is a component of generic ketamine.) NICE initially announced this decision over the summer, and Janssen, the company that makes Spravato, along with the Royal College of Psychiatrists, filed appeals in July, calling the decision unfair. In September, an independent appeal panel ruled that NICE “did not provide sufficient explanation” for its rejection. The new document provides further details explaining the factors the agency considered in their decision.
NICE points to “clinical uncertainty” about esketamine treatment. The agency specifically points to three areas that remain unclear: first, they say, there were inconsistencies in how Janssen defined treatment-resistant depression. They also raise concerns that it’s unclear how long patients would take esketamine as a treatment. (Janssen’s trials followed participants for only four weeks, but NICE considers depression a chronic condition, which may need treatment for 20 years or more). “The long-term evidence of esketamine is too uncertain to justify a substantial modeled benefit over a 20-year time horizon,” NICE writes.
Perhaps most importantly, NICE raises concerns about the cost of treatment and the logistics of implementing it within the country’s National Health Service. In Janssen’s assessment of the cost of implementing esketamine, it assumed the launch would rely on existing infrastructure, but NICE points out that it will cost NHS money to train providers, convert existing facilities to be appropriate for treatment, and transport patients to and from treatment centers.
Psychedelic Alpha’s Josh Hardman says psychedelic drug developers should take note, as these issues are likely to come up as other psychedelics are considered for treatment:
PSYCH predicts psychedelics will be worth $779 million in 2023
This week, psychedelic healthcare company PSYCH released the fourth edition of the Psychedelics as Medicines report, which gives an overview of psychedelic research, business, and patents. Using data on the number of therapists, attitudes of healthcare providers, and survey data from Oregon to assess consumer demand for psychedelic-assisted therapy, PSYCH estimates that if MDMA and psilocybin become regulated for medical purposes, the legal psychedelic healthcare market could be worth more than $3 billion a year. PSYCH estimates the 2023 revenue for ketamine will be $429 million, and that revenue will rise to over $1.2 billion by 2028. It predicts even more growth for psilocybin and MDMA; while the two drugs are estimated to generate around $340 million and $10 million (respectively) in revenue in 2023, PSYCH predicts the two drugs will generate $1.8 billion and over $2 billion in 2028.
Lucid News details the civil trial the family of Baylee Ybarra Gatlin has brought against MAPS and other organizations involved with the Lightning in a Bottle music festival, where Gatlin died in 2017.
Reuters covers Jamaica’s burgeoning psychedelics industry.
Discover features five animals known to experiment with mind-altering substances.
Journalist Mattha Busby writes about his experience with ibogaine for VICE.
The New York Times reports on the return of Luna Luna, an amusement park that debuted in the 1980s with psychedelic works from well-known artists like Salvador Dali and Jean-Michel Basquiat.
The Graduate Theological Union is offering a new online course on psychedelics and religion.
Dezeen features design studio Layer’s concept art for a psychedelics subscription service.
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There is a reason that mystics and shaman used these compounds with extreme caution. They only made these compounds available to people who had gone through a number of initiations and rituals was all for very good reasons. The fact that PSYCH says that psychedelics will be worth more than $750000 bucks by next year is a really troubling prediction. This will attract all the wrong people. What could possibly go wrong?
Regarding psilocybin mushrooms and "bad trips":
When used properly, LSD is a MUCH, MUCH, MUCH better psychedelic than psilocybin mushrooms. LSD contains only ONE substance, LSD, a dose of which is measured in millionths of a gram. Psilocybin mushrooms contain MANY substances other than psilocybin, a dose of which is measured in thousandths of a gram. (A THOUSANDTH OF A GRAM WEIGHS A THOUSAND TIMES MORE THAN A MILLIONTH OF A GRAM.) When someone takes psilocybin mushrooms they are, by comparison to LSD, taking a quite MASSIVELY larger dose of a mix of various substances.
LSD changed the world far, far more in just a few years than psilocybin mushrooms did in thousands of years!