DEA announces hearing on obscure hallucinogenic compounds; Petitioning the FDA for a public meeting on Lykos and MDMA; Psychedelic church sues for defamation
Plus: Maine and Alaska psilocybin task forces; $10 million for psilocybin research in Missouri; new bill updates Colorado’s psilocybin program rules
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
DEA announces hearing on obscure hallucinogenic compounds
On Tuesday, the U.S. Drug Enforcement Administration announced it will hold a hearing on its proposal to add two currently unscheduled hallucinogenic compounds, 2,5-dimethoxy-4-iodoamphetamine (known as DOI) and 2,5-dimethoxy-4-chloroamphetamine (known as DOC), to the list of Schedule I drugs. Since January, the proposal has received over 150 responses which overwhelmingly voice opposition to the DEA proposal. DOI and DOC are used in academic studies, and researchers say scheduling them could slow or hinder scientific research, especially given that there is little evidence the drugs pose a public health threat. (For more on how the drugs are used in research, read our 5 Questions interview with undergraduate researcher Alyssa Gillies.) Commenters include academic researchers, psychedelic companies atai and Panacea Plant Sciences, and the American Society for Pharmacology and Experimental Therapeutics, a professional organization whose president is an official at the U.S. Food and Drug Administration. In its announcement, the DEA says the agency received three requests for a hearing, which will be held on June 10 at the DEA’s headquarters in Arlington, VA.
Petitioning the FDA for a public meeting on Lykos and MDMA
This week, a group of five psychedelics scholars and concerned citizens published a public petition asking the U.S. Food and Drug Administration to schedule an open advisory committee meeting on Lykos Therapeutics’ application to approve MDMA for use in treating PTSD. Such public advisory meetings are not required in the FDA approval process; in commentary published in JAMA last summer, a health policy expert writes that advisory committee meetings have been “steadily declining” over the last decade, “from 47 meetings in 2010 to 18 in 2021.”
The meeting being requested in the petition would provide an opportunity for members of the public to detail any concerns they have about the application to approve MDMA. The writers of the petition detail some of the concerns they have about the non-profit organization MAPS and Lykos, MAPS’s for-profit company, which range from clinical trial safety to organizational culture.
“We hold serious concern that these allegations of entrapment, sexual abuse, and coercive control are directly connected to the organisational culture and psycho-spiritual beliefs around ‘healing’ that are encoded in the MAPS/Lykos protocol,” the petitioners write. They emphasize that the petition does not take a stance on whether or not the FDA should approve MDMA for PTSD. As of Thursday evening, the petition had 20 signatories.
In an emailed statement, MAPS told The Microdose that it “remains fully supportive of comprehensive, high-quality research; careful analysis of safety and efficacy; and stringent regulatory oversight of any psychedelic-assisted therapy research or delivery. We stand behind Lykos’ execution of the clinical program and support the clinical results.” Lykos also told The Microdose that they support having an advisory committee meeting with an open public hearing. “The voice of the PTSD patient is incredibly important,” they added.
We also reached out to the FDA, who confirmed receipt of our request but did not respond by press time.
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‘Psychedelic’ Church sues detractors for defamation
The Church of Sacred Synthesis, formerly known as the Church of Psilomethoxin, is suing its critics for defamation, libel and slander in a Texas district court, according to a new piece published in DoubleBlind. The church formerly claimed that its “sacrament”, a supposedly novel psychedelic drug called psilomethoxin, was created by feeding 5-MeO-DMT to psilocybin-producing fungi. In April 2023, two chemists working at the non-profit medical research organization Usona Institute, tested a sample they claim came from an anonymous member of the church and concluded that there was no evidence it was psilomethoxin. Shortly after, the psychedelics publication Psymposia published a four-part series investigating the church and its claims. Journalist Mattha Busby reports in DoubleBlind that the civil suit names Usona, the Promega Corporation, whose founder Bill Linton also co-founded Usona, Psymposia, and a user on the social media site X.
Maine and Alaska psilocybin task forces, and $10 million for psilocybin research in Missouri
Last week, Maine senators voted to pass LD 1914, a bill that proposes establishing a committee to study a psilocybin services program in the state that is similar to existing programs in Oregon and Colorado. When the bill was first introduced, it proposed establishing psilocybin services directly, but amendments resulted in a committee to study the idea instead. The bill will move on to the Maine House of Representatives for consideration.
Similarly, state representatives in Alaska voted to advance House Bill 228, which would also establish a committee to study the possibility of launching a psilocybin services program. (HB228’s companion bill in the Senate, SB 166, was referred to the Senate Rules Committee.)
Legislators in Missouri passed HB 2010, an appropriations bill for the state’s opioid settlement funds which includes $10 million for studying the use of psilocybin in treating opioid use disorder. An earlier version of the bill originally proposed spending that $10 million on ibogaine research, but according to Marijuana Moment, Cody Smith (R), one of the bill’s sponsors, said the state’s Department of Mental Health had concerns about ibogaine given its cardiac risks.
New bill would update Colorado’s psilocybin program rules
Last Thursday, Colorado Senator Steve Fenberg (D) proposed Senate Bill 198, which would amend some elements of the state’s psilocybin regulations, known as the Natural Medicine Health Act. The bill is clearly meant to clarify rules. For instance, SB 198 explicitly allows testing facilities to test both marijuana and “natural medicine” such as psilocybin mushrooms or products. It also clarifies that individuals, rather than a “person” (which, by its legal definition, could technically include corporations), are prohibited from having a financial interest in more than five natural medicine business licenses. The bill has been assigned to the state’s finance committee and awaits action.
The Australia Broadcasting Corporation interviewed people with hallucinogenic persistent perception disorder, or HPPD, a disorder in which people continue to experience hallucinogenic effects long after a psychedelic trip is over.
Psychedelic Alpha interviewed Kirk Cullimore, a Utah senator who co-sponsored a new bill that allows two healthcare systems in the state to offer psilocybin and MDMA treatments to patients, about what kinds of drugs will be permissible under the new program and what kind of collaboration occurred between bill sponsors and the potential pilot sites listed in the bill.
For The Atlantic, I reported on how psychedelic reform compares to cannabis reform.
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