Coverage by Jack Gorsline in Arlington, Virginia, and Josh Hardman in London.
In a quiet courtroom housed on the second floor of the Drug Enforcement Administration’s (DEA) Museum and Visitors Center in Arlington, Virginia, a legal battle is unfolding over the status of two key psychedelic research chemicals: 2,5-Dimethoxy-4-iodoamphetamine (DOI) and 2,5-Dimethoxy-4-chloroamphetamine (DOC).
DEA moved to place the two drugs in Schedule I late last year, renewing an effort that it initially tabled in spring 2022. That first attempt was withdrawn the same summer, but the agency ominously noted that it was planning to amend its procedure and take another shot at scheduling the pair. This, then, is the rematch, and this time it’s gone to a hearing: the first such in-person hearing to substantively challenge the scheduling of a psychedelic since MDMA’s placement in the mid-’80s.
Students for Sensible Drug Policy (SSDP) and neuroscientist Raul Ramos are the petitioners, represented by attorneys Brett Phelps and Robert Rush.
Despite the ramifications that scheduling the two drugs could have on psychedelic research and the further entrenchment of the war on drugs, the hearing has attracted little public attention, with only a dozen or so in attendance in Arlington. Fortunately, Jack Gorsline is one of those in attendance, which forms the basis of the present dispatch.
Research at Risk
Those opposing the DEA’s proposed rulemaking argue that scheduling the two serotonergic drugs would likely bring a large crop of promising psychedelic research to a halt, especially in the case of DOI, which is widely used by the field.
The fact that the drugs remain unscheduled has made them popular among serotonin researchers, given the much less resource-intensive nature of working with an unscheduled compound. (It’s worth noting that, under the federal analogue act, the drugs would be treated as scheduled compounds if intended for human use, but research uses remain unencumbered by such restrictions.)
One example of DOI’s vital role in promising psychedelics-related research projects was on full display during Friday’s session of the hearing. Psychedelics and serotonin research pioneer David Nichols testified about research into DOI and told the court that the addition of the drug to Schedule I “would be a disaster” for public health.
Nichols also discussed the work of his son, Charles, who has made a number of DOI-related discoveries at Louisiana State University, where the pair have generated an impressive corpus of research.
The younger Nichols was drawn to DOI after Hurricane Katrina destroyed his laboratory’s inventory, leaving him scrambling to find a suitable research chemical in place of a controlled substance he had planned to use in an experiment. His father, David, suggested DOI might be a good substitute. According to David, that work led to the discovery that DOI is one of the most potent anti-inflammatories that the pair had ever seen.
While much of the research into psychedelics and related compounds has focused on neuropsychiatric applications, the Nichols’ discovery of DOI’s anti-inflammatory properties indicates just how many avenues of potentially fruitful research and drug development could be substantially narrowed by scheduling.
Beyond the Lab
Outside of complaints that scheduling would hinder important research, which was a key topic brought forward during the public comment period which closed earlier this year, activists and opponents also took aim at the DEA’s more fundamental agenda of controlling drugs through schedules and associated enforcement activities.
Wayne State University neuroscientist and host of the Psychedelic Brain Science podcast Alaina Jaster, an expert witness for SSDP/Ramos, assumed this broader vantage during the hearing. Jaster, a long-time critic of the criminalisation of drugs at large from both a scientific and humanitarian perspective, held firm in her views during the government’s cross-examination.
During the afternoon of day two, DEA attorney Francis Mann asked Jaster if she believed that no drug should be criminalised, to which Jaster coolly confirmed that she did, indeed, “agree with that statement.”
Later, SSDP co-counsel Brett Phelps asked Jaster to elaborate on her perspective on the war on drugs, which led her to reveal a deeply personal backstory. Her father, as well as his father before him, have struggled with substance abuse, the depths of which led to his absence from Jaster’s life for more than a decade. Jaster’s story was deeply emotional.
Third Time’s A Charm? The Government’s Shaky Case Against DOI and DOC
Having abandoned two attempts at scheduling sets of psychedelics following pushback (as in the case of the five tryptamines and the earlier effort to schedule DOI and DOC), one might assume the government’s case would be airtight on this third attempt.
But the feds’ case seems both thin and shaky, with the government resting its case before the lunch break on the very first day, and a generally poor showing in terms of expert witness testimony.
DEA’s star scientist on the matter is Theresa Carbonaro, a Johns Hopkins psychedelic researcher turned DEA pharmacologist. But some of Carbonaro’s claims were far from consensus and seemed to draw heavily on a Department of Health and Human Services (HHS) report that served as the basis for the government’s renewed effort to schedule the pair of molecules.
That report was published back in December 2023 and concluded by recommending that both DOI and DOC be placed in Schedule I of the Controlled Substances Act. In its preparation of the report, HHS supposedly employed its eight-factor analysis, before forwarding a copy to Carbonaro for her expert review.
At the hearing, however, the very basis for scheduling the two drugs was called into question during the SSDP/Ramos cross-examination of Carbonaro. That cross-examination had to be prepared hastily, as co-petitioner David Heldreth submitted a last-minute request to provide his testimony in writing after coming down with the flu, which bumped SSDP/Ramos counsel up the agenda. The SSDP/Ramos team crafted their initial question over lunch.
But the pair’s pizza-assisted cross-examination plan appeared fruitful, as Carbonaro was forced to admit to certain facts that might lead the average spectator to question the government’s basis for scheduling. For example, when asked to state the number of law enforcement encounters involving DOI and DOC as reported in the National Forensic Laboratory Information System (NFLIS)—which the HHS report concluded was significant evidence of diversion of DOI and DOC from legitimate sources—Carbonaro admitted that there were in fact zero such encounters reported by U.S. law enforcement in the last five years.
When asked to explain her rationale in determining that this fact was consistent with “evidence of significant diversion”, Carbonaro said that “while we didn’t find any evidence of abuse” or of significant diversion, that this “doesn’t mean there isn’t any.” Carbonaro and SSDP/Ramos co-counsel Phelps then had an exchange where the latter sought to tease out the government’s precise definition of ‘significant’.
In another moment, Carbonaro was asked if, in her opinion, “any use of DOI or DOC constitutes abuse”, to which she replied “yes”. Though this is perhaps unsurprising, given that the definition of ‘abuse’ used by the FDA and other government agencies is the intentional, non-therapeutic use of a drug, where ‘therapeutic’ can only pertain to the sanctioned use of approved substances.
Beyond the government’s lacking evidence for diversion or abuse, the bulk of the evidence presented in the HHS report is derived from anonymous or pseudonymous posts on popular internet forums like Erowid and Reddit: Carbonaro noted that the DEA monitors both platforms regularly for reports of “emerging drugs of abuse”.
But the DEA pharmacologist had to admit that she had no proof that the posts were even written by humans, and when asked if she had any proof that one specific post referenced in her testimony was real, Carbonaro replied in the negative.
Week Two Begins
The hearing now enters its second week, with ten non-consecutive days pencilled in for proceedings.
Reflecting on events thus far, SSDP/Ramos co-counsel Phelps seemed confident. “I think it went as well as we could have hoped”, he said, adding that he thinks his side’s evidence “speaks for itself.”
Phelps also believes the hearing will likely conclude by the end of this week, though the fate of DOI and DOC won’t be formally decided or announced for at least a few weeks. Once the hearing concludes, Paul Soeffing—the Administrative Law Judge (ALJ) assigned to the case—will first review testimony provided by both parties before issuing a summary judgment and scheduling recommendation to John Mulrooney II, DEA’s chief ALJ. Mulrooney will review Soeffing’s recommendation before issuing his own verdict.
The hearing’s presiding ALJ, Soeffing, has dealt with a number of cases related to medical licensure during his time on the bench, including a large swath of cases involving the prescribing of controlled substances.
During the present case, he appears to have afforded a significant amount of leeway to SSDP/Ramos counsel and witnesses in establishing the bounds of their scientific expertise. The DEA, meanwhile, has focused many of its objections to the SSDP/Ramos witness’ testimonies on minor discrepancies in their expertise as described in pre-hearing supplemental statements. Might this indicate that the DEA’s legal team is clutching at straws?
Per the agency’s Chief ALJ, Mulrooney, the SSDP/Ramos co-counsel duo of Phelps and Rush appear to be putting in a good innings. “I’ve been watching”, said Mulrooney, “and you guys have been doing a great job.” “I’ve learned a lot”, he added, acknowledging that the information presented by the SSDP/Ramos side would “be helpful” to the matter.
Phelps said that his optimism as we head into week two is largely thanks to the “incredibly qualified people doing incredible work with DOI”, whose “vast knowledge and expertise is coming across in the courtroom.”
“I’m really proud of the work that our people are putting in”, Phelps said, continuing: “I hope the rest of it goes as well as the first week did.”
The hearing continues today.
