Critics frame this mechanism as “prohibition by default,” and the 2-FDCK move has drawn sharp rebukes from experts and advocates. They say that by criminalizing a compound with virtually no footprint in the illicit market, the DEA will stymie research that could yield the next generation of mental health treatments.

The DEA’s justification for the “emergency” nature of the ban has come in for particular criticism. According to the agency’s own data, 2-FDCK has been encountered by US law enforcement a grand total of 52 times since 2018.  

“Only 52 reports over eight years. In a country of 330 million, that’s a reach that borders on the absurd.”

“The problem is that the DEA defines what ‘imminent hazard’ exactly means,” Robert Rush, a Denver-based attorney and founder of the Rights and Reason Project, told Filter. “For 2-FDCK, the attorney general stated the drug is ‘widespread in the United States,’ based on only 52 reports over eight years. In a country of 330 million, that’s a reach that borders on the absurd.”

Rush, who has been prominent in challenging the DEA’s attempts to schedule other research chemicals, said the agency is using the emergency provision to bypass the rigor of the standard scheduling process. “They are creating a crisis where none exists to justify a policy that avoids the sunlight of a public hearing.”  

Kat Murti, executive director of Students for Sensible Drug Policy (SSDP), the nation’s largest youth-led drug policy reform organization, shares these concerns.  

“The DEA’s move to emergency-schedule 2-FDCK as a Schedule I substance is drug policy by panic, not evidence, and we will pay for it in blood,” she told Filter. “Emergency scheduling sidesteps scientific review and public-health input, replacing them with blunt enforcement tools that have repeatedly proven deadly.”

“We’ve seen this pattern over and over again: Rushed bans create chaos, not safety,” Murti continued. “Placing ketamine analogs into Schedule I will not eliminate use or make communities safer. It will push people toward increasingly unregulated and unpredictable markets, increase the risk of adulteration and overdose, and expose people—especially young people—to arrest, incarceration, and lifelong consequences.”

“After 30 days, it just becomes illegal. If you were a scientist developing an isomer or derivative compound from it, that’s too bad. Your work stops.”

Unlike the standard scheduling process, which allows for public commentary, scientific hearings and judicial review, emergency scheduling by the DEA essentially bypasses oversight for up to three years.

“The crazy thing about temporary emergency scheduling is that the ability to question its necessity is removed during the temporary period,” Rush noted. “There’s no opportunity to go to court or to have a hearing. After 30 days, it just becomes illegal. If you were a scientist developing an isomer or derivative compound from it, that’s too bad. Your work stops, and your liability begins.”

Of particular concern to the scientific community is that by placing 2-FDCK in Schedule I—the most restrictive class, reserved for drugs with “no currently accepted medical use”—the DEA will also restrict all of its salts, isomers and salts of isomers. This “blanket” approach is liable to freeze research into dozens of potentially beneficial medical compounds, some of which may not even have been fully identified.

The current fight over 2-FDCK is playing out against the backdrop of a recent, high-profile loss for researchers and advocates. In 2024, the DEA moved to ban DOI and DOC, two psychedelic research chemicals, which had between them been cited in over 1,200 National Institutes of Health-funded papers. Though the ban now looks set to go ahead, Robert Rush, working with SSDP, successfully demanded the first psychedelic scheduling hearing at the DEA since the famed MDMA case of 1985.

“The DEA, for too long, has had a rubber stamp in their decision-making processes,” Rush said of the DOI case at the time. “They have not had to defend their actions. I am looking forward to having the DEA defend its decision to criminalize an important research tool that it admits is not being diverted for illicit use. It is time they answered to the American public.”

Murti and SSDP have been vocal about the damage to critical research caused by the DEA’s moves. That’s particularly relevant with the 2-FDCK plan, given that its relative, ketamine, represents one of the few breakthroughs in depression treatment in recent decades.   

“At a time when we face an unprecedented mental health crisis, it is unconscionable for the DEA to claim that harm to research is irrelevant,” Rush said.

“Prohibition enforced through emergency orders is not public health—it’s a policy choice that puts lives at risk.”

Murti and Rush agree that the federal government must pivot away from what they call “reckless prohibition” toward policies that reflect today’s public health needs.

“If policymakers are serious about saving lives from overdose, the federal government must stop expanding emergency prohibition and instead invest in harm reduction, drug checking, evidence-based education and research,” Murti said. “Prohibition enforced through emergency orders is not public health—it’s a policy choice that puts lives at risk.”

Rush also frames the issue as a fundamental question of cognitive liberty—the right of individuals to maintain autonomy over their own mental states. “Restricting 2-FDCK without clear evidence of unique and substantial harm improperly infringes cognitive liberty by criminalizing mental states,” he argued. “Any regulation must be evidence-based, narrowly tailored, and focused on specific harms rather than speculative harms.”

As the DEA moves to finalize the temporary order, the Rights and Reason Project, SSDP and others are aiming, through legal challenges and advocacy, to end the days of “stealth” scheduling.

“They locked LSD, MDMA and psilocybin away, and decades later, we are still fighting to research these drugs with significant therapeutic potential,” Rush said. “Someone needs to fight this reckless prohibition, or we will repeat the mistakes of the past indefinitely.”

Image (adapted) via Wikimedia Commons/Public Domain

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As ordered by President Donald Trump, the National Institutes of Health (NIH) is aiming to reduce spending by capping the “indirect costs” covered for any research it funds at just 15 percent of the total funding for a given project. It’s part of a larger campaign by Musk and DOGE to gut federal public health agencies; already, 5,200 probationary employees of the department of Health and Human Services (HHS), the parent department of NIH, have been fired.

Indirect costs, or overheads, make up a large portion of the funding the NIH provides to universities conducting medical research. Harvard, for example, received $135 million to cover indirect research costs in 2024, according to NPR—69 percent of the total funding the university received from NIH. These taxpayer dollars help pay for items including building and lab maintenance, equipment and supplies, and administrative staff salaries.

On February 21, Judge Kelley extended the restraining order as she weighs a final decision.

The cuts are on hold, for the moment. After the administration’s policy was announced on February 7, 22 states, including California, New York and Illinois, sued the NIH and HHS to prevent the order from taking effect.

On February 10, a federal judge in Massachusetts, Angel Kelley, issued a temporary restraining order for federal agencies to take no action to implement the plan. On February 21, Judge Kelley extended the restraining order as she weighs a final decision. She considered issuing a preliminary injunction, and said she would work “as quickly as I can.”

Another two active lawsuits against the NIH to stop the cuts advancing involve challenges from the Association of American Medical Colleges and from the Association of American Universities.

The administration’s current plan is actually a rehash of something Trump tried during in his first time in office. His first proposed budget for fiscal year 2018 involved a 22 percent cut to NIH funding and targeted indirect costs even more aggressively, limiting them to 10 percent. A former NIH director warned then that this would “disembowel” key medical research nationwide.

The Republican-controlled Congress at the time rejected Trump’s plan, passing legislation on a bipartisan basis to prevent indirect-cost reimbursements to research institutions being capped.

Research on drugs and drug use is an important tool in the nation’s efforts to address the worst overdose crisis in its history. And the NIH, through programs like the “Helping to End Addiction Longterm Initiative” (HEAL), has played a major role. In fiscal year 2019—during Trump’s first term—the NIH HEAL program awarded $945 million in “grants, contracts, and cooperative agreements” to researchers in 41 states, whose work focused on areas like improving treatments for chronic pain, curbing rates of opioid use disorder and achieving long-term recovery.

Under President Biden, the National Institute on Drug Abuse (NIDA, part of the NIH) established a research network to test community-based harm reduction strategies. Launched in 2022, this five-year, $36 million initiative involved nine research centers and a coordinating center. Its projects included looking at how to expand harm reduction through mobile vans, digital services and peer outreach workers.

For Dr. Pho’s harm reduction research, about 50 percent of the NIH funding covers indirect costs.

Dr. Mai Tuyet Pho is an infectious disease researcher at the University of Chicago, currently working on an investigation that’s fully funded by the NIH. Pho works with three harm reduction providers in Illinois, covering 35 predominantly rural counties with less access to harm reduction services and supplies.

She is studying how participants in services like syringe service programs can help get supplies out in their communities—by receiving extra syringes, naloxone or other tools, which they can then share with their friends and families. Pho is also investigating how to innovate in rural harm reduction through vending machines, locker drop-offs and mail order services.

For Pho’s research, about 50 percent of the NIH funding covers “direct” costs—paying participants and research assistants, procuring certain supplies, conducting testing for diseases like HIV and hepatitis C, and working with community partners. The other 50 percent of her funding covers indirect costs.

“The indirect costs, those are the infrastructural costs required to do any of this research,” Pho told Filter. “To keep the lights on at the university in terms of budget administration—getting the funds from NIH and disbursing them. A really important piece is participant and study safety, that includes supporting the institutional review board that reviews all the work we do. Every single survey, instrument, protocol, has to go through intensive review before we would ever expose anyone to that.”

“It’s something that’s so hard to imagine happening, but it’s very real. We would probably have to shut down the study.”

If Trump’s plan goes forward, it would therefore threaten Pho’s harm reduction investigation.

“It would slow everything down, certainly,” she said. “I’m not sure how long we could go. The infrastructure indirect costs support are essential to our day-to-day. If we don’t have a functioning review board, we can’t do our research. If we don’t have the data collection platform, we can’t collect any data … It’s just as essential as the direct costs. It’s something that’s so hard to imagine happening, but it’s very real. We would probably have to shut down the study.”

Pho praised the NIH as an effective partner, and said there is no other institution providing as much funding to harm reduction research. In the event of NIH funding being pulled, she said she wouldn’t want to have to compete with direct harm reduction providers for any independent funding sources.

There’s a climate of fear among many researchers as they wait to see whether their work will be impacted by cuts. While some have spoken out to media about the threat, others reached by Filter didn’t want to speak on the record, worried about the implications of drawing attention to their projects.

The extent to which Trump and Musk may succeed in gutting federal research funding remains to be seen, with lawsuits yet to be resolved. But if the cuts are blocked in the courts, Trump may well find Congress more compliant than he did in his first term.

Photograph via Picryl/Public Domain

The post “It’s Very Real”—Harm Reduction Research Facing DOGE Funding Cuts appeared first on Filter.

Breaking Convention (BC) is the largest psychedelics conference in Europe, a not-for-profit event that feels like a festival. From April 19-22, more than 1,000 people convened at the University of Exeter in Devon, England—twice the attendance of 2011, when the biennial conference was first held.

The event’s name references the United Nations Single Convention on Narcotic Drugs. Organizers believe that BC’s interdisciplinary nature is what’s needed to effect global change, even if they aren’t all in agreement about what that change should look like.

“It’s a cultural event as much as a scientific event,” Leor Roseman, a researcher at Imperial College London studying ayahuasca use among Israeli and Palestinian groups, said at the BC press conference. It “represents the psychedelic ethos in the most precise way: by being very broad.” 

“Seeing where the space is heading, it’s a rich person’s game.”

Sure enough, panelists spoke on themes as diverse as psychedelic-assisted therapy; decolonization and equitable futures; metaphysics; microdosing; and ethnomycology. Advocacy groups Psilocybin Access Rights campaign and DrugScience were both well-represented. One panel was devoted entirely to trance music sampling Terence McKenna’s disembodied voice. And workshops, art installations and virtual reality simulations of psychedelic journeys abounded.

All panels were recorded and are being made available to the public on YouTube, as part of a push toward increased accessibility.

“Seeing where the space is heading, it’s a rich person’s game,” Richard Tyo, clinical director at Neuma Centre in Ontario, Canada, told Filter. The goal is to build a movement of “co-creation [and] relationships … and not rely on the commercialization and corporatization of psychedelics.”

Ketamine and ibogaine, each given its own forum, were presented as cautionary tales for the movement. Both have been marketed as miracle cures to Westerners and have increasingly been accessed in unregulated, profit-driven settings. Speakers described the alternative models—grounded in community relationships and fair-trade ethics—that could help reduce the harms of current practices, at both the individual and societal levels.

Psychedelic harm reduction had a strong presence.

“We’ve gotten a bit unbalanced and myopic on on the medical side,” Exeter psychopharmacology professor Celia Morgan, who chaired the ketamine forum, told Filter.  “It was brilliant to get the experiential side of things, like movement medicine and a tea ceremony … a holistic perspective [that] is sadly lacking in other conferences.”

Psychedelic harm reduction had a strong presence. Speakers emphasized the role of peer support at festivals, or on spiritual journeys like 5-MeO-DMT ceremonies. Others described the potential of psychedelic harm reduction tools like preparedness scales for certain types of ceremonies, or techniques for regulating the central nervous system.

Accessibility for Indigenous populations was discussed at a number of scheduled events. Speakers shared statements from ayahuasceros, as well as from Gabonese communities about ethical iboga sourcing and use in the Global North.

BC seemed lacking in queer-focused panel discussions, though, despite plenty of queer representation in the crowd.

Psychedelic exceptionalism and the dangers that come with it were also discussed. Psychotherapist Roberta Murphy was among panelists who described concern “that the pace of psychedelic research is outstripping the kind of necessary grounding [for] doing this work safely and ethically.”

To me, BC’s most impactful event was the forum on pan-African perspectives. “It was the best experience I’ve ever had speaking at an event,” said Acacea Sherman-Lewis, founder of Divine Master Alchemy Academy. “Because I was among family.” 

Correction, May 3: Due to an editorial error, an earlier version of this article wrongly suggested that psilocybin mushroom extracts were sold at the event; this was not the case.

Image by sergeitokmakov via Pixabay

The post A Psychedelics Conference Tackles the Future of the Movement appeared first on Filter.

The US Bureau of Labor Statistics (BLS) released the report last month. It also found that a small proportion of workplaces have eliminated or delayed screening of workers for drugs including alcohol during the COVID-19 pandemic.

The report is part of a project measuring businesses’ response to the pandemic. It appears to be the first time since 1996 that the workforce fact-finding agency has asked employers about drug screening.

During that time, nearly three-quarters of all US states have since legalized medical marijuana, while more than a third have okayed cannabis for adult use. The report shows that drug testing is generally less prevalent in states that have opted to legalize.

As might be expected, workers in safety-sensitive industries like transportation and warehousing were most likely to be tested compared to other sectors like food services, arts and educational services.

In 1996, about 30 percent of all surveyed worksites said they tested for drugs, while about 14 percent said they screened for alcohol. In the new survey, 16.1 percent said they tested for drugs and/or alcohol.

The survey went out to roughly 317,000 establishments across the country and received usable responses (with answers to at least five of 25 questions) from more than 80,000 workplaces. Unlike most other BLS surveys, employers were asked to answer questions online and without the presence of an interviewer.

Two of the survey questions asked about testing for drugs including alcohol. One asked whether the worksite was currently testing new applicants or current employees for drugs, and the other asked whether the workplace reduced or delayed testing since the beginning of the pandemic.

Michael Dalton, a BLS research economist who worked on the survey, told Marijuana Moment that he pushed to add the drug-screening questions to the employer after seeing media reports that some companies had stopped testing employees and job applicants in order to make it easier to fill open positions.

“There seemed to be a few stories, and these were, as far as I’ve read, entirely anecdotal,” Dalton said. “Part of where where it hit a brick wall was that we didn’t have recent data about drug testing.”

While the BLS report found evidence of a decrease in screenings generally, that reduction was slight—only 2 percent of workplaces said they’d eliminated or delayed testing, while 7.9 percent said that they eliminated or delayed testing and also tested new applicants or current employees.

The findings nevertheless shed light on practices by private employers around the country, analyzed by size of the facility, industry sector and state.

The report defines establishments not as business entities but as individual physical locations, meaning that for the purposes of the survey, a business with one office in two different states would represent two separate establishments, each of which would need to return a questionnaire.

Dalton said he hopes future reports will allow analysis by total company size. “We also have estimates that are not publicly available just yet where we look at average wage paid within the establishment.”

One of the more robust associations the survey found was that establishments in states with legal cannabis tended to be less likely to screen workers. Eight out 10 states with the lowest percentage of establishments drug testing have legalized marijuana for adult use. Among the 10 states with the highest screening rates, meanwhile, not one has legalized cannabis.

[Thread 5] Drug testing. There were a smattering of stories about employers eliminating drug testing requirements to make it easier to hire, also overdose deaths exceeded 100k last year. So we included some questions about employer drug testing. pic.twitter.com/76GZtrjKyo

— Mike Dalton (@WhereTheJobsAt) February 9, 2022

Any causal relationship, of course, is unclear from the available data. It’s possible that more employers decided against screening workers as a result of legalization, but it’s also possible that underlying local attitudes—toward personal freedom, privacy or off-duty drug use, for instance—helped to drive both legalization and relatively lower testing rates.

Vast differences were also seen across industry sectors, in part due to ongoing federal cannabis prohibition. The transportation and warehousing sector and utilities sector both had testing rates far higher than the rest. Transportation and warehousing, which includes the federally regulated trucking industry and others, was the only category of businesses in which more than half of establishments said they screened for drugs.

Among the sectors with the lowest rates of testing were accommodation and food services; arts, entertainment and recreation; information; educational services and financial activities.

Adding to the thread this interesting tidbit.
Transportation and warehousing is the only sector drug or alcohol testing at more than half of the establishmentshttps://t.co/gcyNccDQZa

— Mike Dalton (@WhereTheJobsAt) February 16, 2022

More employers in the utilities sector reduced drug testing during the pandemic than in any other sector, but that doesn’t mean they stopped screening entirely. The sector also had the highest proportion of establishments that both reduced or delayed testing and also tested new applicants or current employees

In terms of size, smaller facilities were far less likely to require screenings. Among establishments with fewer than 20 workers, 12.9 percent tested workers or employees. Of workplaces with between 20 and 100 people, 34.7 percent did. Those numbers continued to climb at sites with between 100 and 500 people and (56.7 percent) and those with more 500 people (69.9 percent).

Prior to 1996, Dalton said, the last BLS question about drug screening that he could find was from 1988.

Dalton said it was too early to tell whether any decreases in drug screening that occurred during the pandemic would persist afterward. He acknowledged that while many COVID-related workplace changes could fade, others aren’t likely to be reversed entirely.

When BLS asked about remote work during the pandemic, for example, “about 20 percent of all establishments said they increased telework and expect those increases to continue later,” Dalton said.

Photograph via Wikimedia Commons/Creative Commons 4.0

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on Twitter and Facebook, and sign up for its newsletter.

The post Feds’ Survey Reveals Which Industries Drug-Test Employees the Most appeared first on Filter.

In a notice of interest published on February 18, the agency outlined the types of study proposals it hopes to fund and gave instructions to researchers on how to apply. NIDA said the guidance is informed by recommendations from a workgroup it set up to explore the issue in 2018.

The study solicitation is nearly identical to one NIDA put out in 2019, but that earlier notice expired last month. Evidently the agency is committed to seeing these research objectives through and has renewed them with the new filing.

NIDA’s notice is meant to “encourage grant applications on the effects of changing cannabis laws and policies in the US and globally on public health,” it said.

“Policies around of cannabis products (including whole plant cannabis and cannabis constituent compounds) in the United States (and globally) continue to evolve, and far outpace the knowledge needed to determine the public health impacts of these changes,” the notice says. “Growing numbers of states have loosened restrictions on cannabis, including those on sales and use, by passing medical marijuana laws or by making cannabis legal for adult recreational use, and in increasing numbers, states have done both.”

Examples of potential studies include developing standardized methods of measuring marijuana and its components, enhancing epidemiological research on cannabis use, determining “physical and mental health antecedents” of marijuana use, exploring the reasons people start to consume cannabis and continue to use it for therapeutic purposes, and several other health-focused topics.

 It’s another example of a federal agency effectively recognizing the inevitability of legalization.

Interestingly, NIDA also again said it would be interested in funding research into “the heterogeneity of regulatory schemes (e.g. models for retail distribution of cannabis products) to understand which combinations or components minimize harm to public health.”

The reason that’s notable is because it’s another example of a federal agency effectively recognizing the inevitability of legalization and the need to start seriously thinking about regulatory models for cannabis.

NIDA emphasized that researchers must comply with the standard THC unit of five milligrams, which it developed and put into place last year, in order to conduct studies with human subjects.

Of course, even as NIDA encourages this kind of research, the head of the agency has repeatedly recognized that marijuana’s status as a Schedule I drug makes the application process onerous. NIDA Director Nora Volkow went so far as to say last year that even she is reluctant to conduct studies on Schedule I drugs like cannabis because of the “cumbersome” rules that scientists face.

NIDA submitted a separate report to Congress in October emphasizing that the Schedule I status of controlled substances such as marijuana is preventing or otherwise discouraging research into their potential risks and benefits.

A National Cancer Institute research team similarly complained about the administrative barriers of marijuana research in a paper published late last year.

Several federal health agencies have worked to bolster cannabis science as the legalization movement spreads. In 2020, for example, the National Center for Complementary and Integrative Health (NCCIH) highlighted funding opportunities for research into the therapeutic benefits of marijuana with an emphasis on pain management.

While the Schedule I restrictions remain challenging, the Drug Enforcement Administration (DEA) has taken steps to make substances like cannabis and psilocybin more available for research purposes by significantly increasing annual production quotas and ending the federal marijuana manufacturing monopoly.

Photograph via Pixabay

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on Twitter and Facebook, and sign up for its newsletter.

The post NIDA Wants to Fund Research Into Marijuana Legalization Models appeared first on Filter.

The DEA faced significant pushback from the research community after posting a scheduling notice for five tryptamines: 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET and DiPT. Nearly 600 people wrote public comments on the proposed rule, virtually all of them in opposition.

The comment period has historically been where the public’s role in federal drug rulemaking stops. But in this case, several different parties submitted requests to have a legal hearing on the planned ban to demonstrate why placing the psychedelics in Schedule I of the Controlled Substances Act would be unnecessary and have a chilling effect on science.

On February 16, Administrative Law Judge Teresa Wallbaum issued an order that sets those hearings into motion. First, the DEA will need to submit a prehearing statement by March 28. The researchers, advocates and stakeholders contesting the rule have until April 27. And a prehearing conference will be held virtually on May 4.

The DEA isn’t bound by the judge’s recommendation, and past administrators have ignored them.

The function of the Office of Administrative Law Judges is specifically to adjudicate in cases related to DEA enforcement and regulations. In this case, the opponents of the agency’s proposed ban are hoping the judge will ultimately recommend either a lower schedule or no schedule at all for the five compounds.

That said, the head of the DEA isn’t bound by the judge’s recommendation, and past administrators have ignored them in similar cases.

Still, Matt Zorn, an attorney representing one of the companies protesting the DEA scheduling action, told Marijuana Moment that taking this step is an important way to hold the agency accountable and get answers.

“The administrative process is capturing a lot of interest within the psychedelic space, and the narrative is going to continue” as these hearings proceed, he said.

“It’s a good sign when folks are interested in how our government works and how drug policy is conducted,” said Zorn, who has an extensive professional history of litigating against the DEA. “I think that this will be a positive step forward for folks to understand how this process works.”

Not everyone who takes issue with a DEA regulation is entitled to this type of administrative hearing. Each person or entity that makes a request for a hearing must demonstrate that they would be uniquely impacted by the policy change, adding to the significance of the fact that the judge granted five requests for this one proposal.

It’s also been quite some time since a scheduling proposal was subject to this kind of administrative adjudication.

In 1988, DEA Administrative Law Judge Francis Young famously challenged the agency’s classification of marijuana as a Schedule I drug, arguing that cannabis is “one of the safest therapeutically active substances known to man” and “marijuana can be safely used within a supervised routine of medical care.”

“It would be unreasonable, arbitrary and capricious for DEA to continue to stand between those sufferers and the benefits of this substance in light of the evidence in this record,” Young said at the time.

The agency, however, ignored the judge’s position and kept marijuana in Schedule I.

In its initial rulemaking filing for the five tryptamines, the DEA said that it took into account research and recommendations from the US Department of Health and Human Services, which found that “these substances are being abused for their hallucinogenic properties,” as well as its own eight-factor analyses, before it made the scheduling proposal.

The proposed ban could interrupt research and development of medicines for serious mental illnesses.

DEA said in last month’s notice that agencies have identified cases of hospitalizations related to the use of two of the tryptamines. It was only able to cite one death where one of the compounds, 5-MeO-AMT, was found in the person’s system, in addition to alcohol and an antidepressant. DEA acknowledged that “it is unclear what role 5-MeO-AMT played in the death.”

The hearing request letters, obtained by Marijuana Moment, contest the agency’s justification for the proposed ban on the basis that it was not only unnecessary given the limited evidence of “abuse” potential, but would also interrupt the research and development of medicines that could help treat serious mental illnesses.

Meanwhile, a Seattle doctor specializing in end-of-life care recently filed a formal petition with DEA challenging the government’s Schedule I classification of psilocybin, the main psychoactive component of psychedelic mushrooms.

The petition requests the agency to reschedule psilocybin as a less-restricted Schedule II drug, pointing to its relatively low potential for “abuse” and “exceptional promise in relieving debilitating symptoms in those with intractable and otherwise untreatable illness,” including the severe anxiety and depression that can result from a terminal illness.

Attorneys for Dr. Sunil Aggarwal filed the federal petition almost immediately following a decision by the US Court of Appeals for the Ninth Circuit that dismissed on procedural grounds a lawsuit Aggarwal and two of his terminally ill cancer patients filed against DEA last year.

In that case, plaintiffs argued they should be allowed legal access to psilocybin under state and federal right-to-try laws, which are intended to let patients with terminal conditions try investigational medications that have not been approved for general use.

Separately, a bipartisan group of members of Congress sent a letter last month urging the DEA to let terminally ill patients have access to psilocybin. The agency, lawmakers said, is “obstructing access to psilocybin for therapeutic use consistent with the letter and intent Right to Try (RTT) laws.”

Congress and 41 states have adopted RTT laws, which allow patients with terminal conditions to try investigational medications that have not been approved for general use. Lawmakers said that DEA “has failed to abide” by the law.

DEA has increased production quotas for the production of certain psychedelics like psilocybin in an effort to promote research, but its scheduling decisions have continued to represent obstacles for scientists.

Read the administrative court’s notice of hearings and the related requests below: 

Photograph via National Institutes of Health

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on Twitter and Facebook, and sign up for its newsletter.

The post DEA Psychedelics Ban to Undergo Rare Legal Hearings—Which May Be Ignored appeared first on Filter.

This is not only true from an ethical standpoint but also in terms of effectiveness and logistics. In the drug policy and drug-user health realms, people with lived experience offer invaluable insights and trusted access to the community. Both of these are integral to the work.

Yet despite this, the involvement of people who use drugs is often last-minute, tokenistic or even harmful to those who put their hand up. If anyone understands the importance of doing it better, it’s Annie Madden.

Located in Sydney, Australia, Madden is currently completing her PhD at the Centre for Social Research in Health at the University of New South Wales. Her PhD looks at “drug-user representation in high-level drug policy settings” from the perspectives of those who do this work and those who work with them.

“I have been that person. I know what it’s like. And I know what it takes.”

Madden refers to herself as a global drug-user activist, and her past career backs that up. Her PhD follows 16 years as the CEO of AIVL (the Australian Injecting and Illicit Drug Users League) along with other senior roles in organizations including NUAA (NSW Users and AIDS Association).

Her days in drug-user activism can be traced back to the late ‘80s at university in Queensland, where—as an injecting drug user herself—she saw the advent of HIV/AIDS and helped found one of Australia’s first peer-based drug-user organizations and syringe programs. She was later awarded the Order of Australia for distinguished service to community health, policy and advocacy.

“There’s some research around consumer participation in drug treatment or recovery settings, things like that, but nothing that looks at a high level,” Madden told Filter of her move to academia. “People who use drugs have been in these really high-level policy spaces for decades but no one really knows anything about it.”

By high-level, she means things like ministerial committees, parliamentary inquiries, drug summits and settings like the UN Commission on Narcotic Drugs (CND). She has completed a 30-year review of these types of events alongside interviewing people globally on what these environments are like for directly impacted people.

“I wanted to know, what happens to drug-user representatives in those environments?” she said. “What’s it like, to be that person at the table? To be the single person with lived experience on a large, highly-credentialed committee?”

Applying critical feminist and poststructuralist theories, Madden hopes to avoid the type of academic work that sits in a drawer, and instead create something that is accessible and useable. The aim is to help people with lived experience to not only continue to get a seat at the table but to thrive there.

“I’m not pretending to have some objective viewpoint here either,” Madden said. “I have been that person. I know what it’s like. And I know what it takes.”

“I’ve never been so politely fucked over in my whole life.”

Perhaps not surprisingly, her research (which will be finished early next year) has exposed a troubling environment. There are overt discriminatory and stigmatizing behaviors, but also those that are not conscious, which in many ways makes them harder to tackle.

Things like the location of events—given that it can be difficult for people who use drugs to travel—can be a barrier. But the more harmful moments are those subconscious attitudes.

As Madden put it, “I’ve never been so politely fucked over in my whole life.”

It takes a lot of bravery to enter these environments as someone who uses drugs, yet for some people, being the voice of their community is worth the pressures.

A new mentorship program from INHSU (the International Network on Health and Hepatitis in Substance Users) and INPUD (the International Network of People Who Use Drugs) hopes to encourage others to do the same.

Last month, the Jude Byrne Emerging Female Leader Award was launched at the 9th International Conference on Health and Hepatitis Care in Substance Users (INHSU 2021) in honor of global drug-user activist Jude Byrne, who passed away in 2020. Two mentorships will be awarded, to activists with lived experience who identify as women.

“Jude Byrne was instrumental to the drug-user rights movement,” INPUD Executive Director Judy Chang, who is based in London, England, told Filter. “She helped to found INPUD, was a mentor figure to a lot of people who use drugs and was instrumental in bringing people to the movement and inspiring them.”

While there has been a lot of informal mentorship within the drug-user activism movement, as far as anyone knows, this is the first formal program to assist people who use drugs to gain the skills, knowledge and support to thrive at whatever level they aspire to—local, national or international.

“There are a lot of unique stresses to being a leader within the movement, which has led to a realization globally that we need to build resilience,” Chang said. “It shouldn’t just be a few key people. Devastatingly, a lot of activists that people looked up to have also died due to the overdose crises or the impacts of criminalization.”

The nine-month mentor program (sign up here to be alerted when applications open) hopes to build the next generation of leaders and will be very flexible. Award recipients will be able to choose what area to specialize in—such as research, advocacy, community mobilization, or anything else they might want to focus on.

“We want to see people who use drugs there from the very beginning … in the research design phase, all the way to the writing and publishing.”

Chang—who has lived experience, as well as an extensive history of leadership roles in drug-user organizations—has for many years advocated for people who use drugs to take active roles in research, policy and advocacy. The mentorship program is the antithesis to what she has seen happen time and again, in line with Madden’s research: the tokenization of people who use drugs in these environments.

We can only hope that opportunities like this, and research like Madden’s, will increase momentum toward people who use drugs having a deeper impact on the research and policies that shape their future.

Until then, Chang, Madden and others have some practical advice for researchers and project managers. “We want to see people who use drugs there from the very beginning,” Chang explained. “We want to see them in the research design phase, all the way to the writing and publishing.”

She added that while this could require some capacity building along the way, the pros far outweigh the cons. “You need to plan to assign more budget and more resources from the very beginning. You need to put this effort in—to take people on that journey—because otherwise, it’s always just going to be a tick-box activity.” 

Photograph by Christina @ wocintechchat.com on Unsplash

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In a document that was submitted to the House and Senate Appropriations Committees, as requested under previously enacted spending legislation, NIDA discussed “barriers to research with Schedule I substances” such as the “administratively complex” process scientists must follow in order to receive federal authorization from the Drug Enforcement Administration (DEA) to study the drugs.

“Researchers have reported that obtaining a new registration can take more than a year, that modifying a registration can also be time consuming, and that differing interpretations of the Schedule I registration requirements among local DEA field offices, research institutions, as well as distinct federal and state registration requirements, greatly complicate the process,” the federal agency told lawmakers. “These challenges can impede critical research on Schedule I substances and deter or prevent scientists from pursuing such work.”

It added that “an overarching concern expressed by researchers is a lack of transparency regarding registration requirements for Schedule I and Schedule II-V substances, and differing interpretations of those requirements by DEA field agents and research institutions.”

NIDA listed a series of issues that scientists have raised about Schedule I research barriers: 

* When a drug is classified in Schedule I, that can result in “unexpected delays in ongoing research.”

* Researchers who need to change course in a study of a Schedule I substance—including something seemingly minor like adjusting the quantity being used—must re-register with DEA, causing further delays.

* Previously, just one person in a team of investigators would need to be registered with DEA. That’s apparently changed over time, with researchers telling NIDA that all members of the team require separate registration.

* DEA in some cases has required researchers to obtain multiple registrations for every physical site at which they carry out studies into Schedule I drugs, even if all the research is contained to a single campus.

* Complications surrounding access to different formulations and dosages of Schedule I drugs have also proved challenging, such and have caused confusion about whether a separate and more expensive manufacturing registration is needed for researchers whose studies require, for example, dissolving marijuana extracts in ethanol or oil before they can be used.

Researchers are currently limited to cannabis grown exclusively at the University of Mississippi.

A separate section of the report focuses specifically on “challenges associated with conducting marijuana research, which go beyond those related to the registration process” and thus deserve “separate mention in light of the increasing availability and potency of marijuana and the proliferation of new marijuana products.”

It notes that researchers are currently limited to a supply of cannabis that’s grown exclusively at the University of Mississippi, which is currently the only federally authorized marijuana manufacturer. Lawmakers and scientists have long argued that the cannabis grown at the facility is inconsistent with products available in state-legal markets, raising questions about the validity of research that depends on the government’s marijuana.

DEA said this year that it is taking steps toward approving additional applications to become federally authorized marijuana producers for research purposes. At the same time, it is proposing significant increases in the production of research-grade Schedule I drugs like marijuana, psilocybin and MDMA for 2022.

But NIDA pointed out that even while approving new manufacturers would “increase the diversity of products and formulations available to researchers,” it still wouldn’t shed light on the kinds of products that consumers are purchasing from legal markets in a growing number of states.

“Researchers supported by NIDA and other federal agencies are unable to use federal funds to purchase marijuana available through state marijuana dispensaries,” the agency said.

“Moreover, some universities have expressed reticence about allowing investigators to purchase dispensary products with non-federal funds or do research with these products on university grounds for fear of violating federal law,” it said.

“These products may differ from the actual products being sold to consumers. The inability of researchers to access marketed products may pose barriers to studying the health effects of products that individuals are using in real-world settings.”

NIDA Director Nora Volkow made similar remarks in a recent interview with Marijuana Moment, saying that she thinks “it would be theoretically ideal to understand the actual products that people are consuming, as opposed to trying to understand it with a different compound—a different plant that will vary in terms of the contents of ingredients.”

“The Committee believes we should be lowering regulatory and other barriers to conducting this research.”

Several measures to address the issue are being considered in Congress.

Last week, a bipartisan group of House members filed one such bill which, in addition to generally streamlining the research registration process, would allow scientists to study dispensary cannabis.

Late last year, the House approved an identical version of the marijuana science legislation. Days later, the Senate passed a similar bill but nothing ended up getting to the president’s desk by the end of the last Congress. Earlier this year, a bipartisan group of senators refiled their marijuana research measure for the current 117th Congress.

Meanwhile, lawmakers are also advancing a separate strategy to open up dispensary cannabis to researchers. Large-scale infrastructure legislation that has passed both chambers in differing forms and which is pending final action contains provisions aimed at allowing researchers to study the actual marijuana that consumers are purchasing from state-legal businesses instead of having to use only government-grown cannabis.

The existence of the newly revealed NIDA overview of Schedule I research barriers was made public in a Senate Appropriations Committee report attached to a spending package that was released last week.

The panel expressed concerns about “restrictions associated with Schedule I of the Controlled Substance Act which effectively limits the amount and type of research that can be conducted on certain Schedule I drugs, especially opioids, marijuana or its component chemicals and new synthetic drugs and analogs.”

“At a time when we need as much information as possible about these drugs and antidotes for their harmful effects, the Committee believes we should be lowering regulatory and other barriers to conducting this research,” it said.

However, the committee said it “appreciates NIDA’s completion of a report on the barriers to research that result from the classification of drugs and compounds as Schedule I substances including the challenges researchers face as a result of limited access to sources of marijuana including dispensary products.”

Read NIDA’s report on Schedule I research barriers below: 

Photograph via National Institute on Drug Abuse

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on Twitter and Facebook, and sign up for its newsletter.

The post NIDA to Congress: Schedule I Is Obstructing “Critical Research” on Marijuana, Opioids appeared first on Filter.

The intent of the provision, which is tucked into a 1,200-plus-page transit bill that will go before the House Transportation and Infrastructure Committee on June 9, is to let scientists conduct impaired driving research using the actual marijuana products that consumers are purchasing and using. It would also allow the interstate distribution of cannabis to scientists in jurisdictions that have not yet enacted legalization.

This is not the main crux of the INVEST in America Act, a bill focused on providing funding for highway and transportation projects. An earlier version of the measure cleared the House last Congress with identical marijuana provisions but did not advance in the GOP-controlled Senate.

The legislation also contains a separate section that would require legal marijuana states—and only those states—to consider methods of educating people about and discouraging impaired driving from cannabis. Advocates take issue with that language simply because it targets legalized jurisdictions while ignoring the fact that marijuana-impaired driving takes place regardless of its legal status.

But they are encouraged by the provision calling on the Department of Transportation to consult with the attorney general and Department of Health and Human Services to develop a report with recommendations on providing researchers with access to “samples and strains of marijuana and products containing marijuana lawfully being offered to patients or consumers” in legal states.

The report should also explore “establishing a national clearinghouse to collect and distribute samples and strains of marijuana for scientific research,” the text of the proposal states, and that would include cannabis from state-legal markets.

Finally, the measure states that the report, which would be due two years after the bill’s enactment, should analyze “statutory and regulatory barriers to the conduct of scientific research and the establishment of a national clearinghouse for purposes of facilitating research on marijuana-impaired driving.”

While these cannabis-related provisions may seem somewhat outside the scope of the large-scale transportation legislation, the research elements could help resolve an ongoing access issue for researchers interested in studying marijuana while the substance is strictly controlled under federal statute.

But since the bill’s initial introduction last year, some steps have been taken to resolve that issue. Most notably, the Drug Enforcement Administration (DEA) recently notified several companies that it is moving toward approving their applications to become federally authorized marijuana manufacturers for research purposes.

That marks a significant development—and one of the first cannabis-related moves to come out of the Biden administration. There is currently a monopoly on federal cannabis cultivation, with the University of Mississippi having operated the only approved facility for the past half-century.

But that move from DEA would still not free up researchers to access marijuana products from state-legal retailers in the way the transportation bill would allow if it is enacted.

The other cannabis provision that was included in the base transportation bill has not been well-received by reform advocates.

Under the legislation, sponsored by House Transportation Committee Chairman Peter DeFazio (D-OR), a section of current law requiring that states establish highway safety programs would be amended to add a section stipulating that states “which have legalized medicinal or recreational marijuana shall consider programs in addition to the programs … to educate drivers on the risks associated with marijuana-impaired driving and to reduce injuries and deaths resulting from individuals driving motor vehicles while impaired by marijuana.”

While advocates are supportive of measures to reduce impaired driving, some have raised issues with the implication that legalizing cannabis increases the risk of people driving while under the influence. Research isn’t settled on that subject.

A federally funded study recently promoted by the National Institute of Justice also found that the amount of THC in a person’s system after consuming marijuana is not an accurate predictor of impairment.

Photograph via Pixabay

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on Twitter and Facebook, and sign up for its newsletter.

The post Bill Would Finally Let Researchers Obtain Marijuana From Dispensaries appeared first on Filter.

While numerous cities across the U.S. have adopted measures to deprioritize enforcement of laws against entheogenic plants and fungi—and Oregon voted to legalize psilocybin mushrooms for medical use—the local legislators did not take action beyond talking about psychedelics research and outlining the various policy challenges associated with state and federal prohibition.

“We’re heading in this direction—it’s just research needs to be done and the groundwork needs to be laid,” one member said at the work session, which was first reported by Aspen Daily News.

There was considerable discussion during the meeting about Denver’s historic move to decriminalize psilocybin in 2019. But while one member said the council “could take similar actions,” another member pointed out that there is no municipal law prohibiting the substance as it stands, and so it would require a state law change to actually decriminalize.

Several members said that formally promoting decriminalization could create complications for law enforcement.

Also, if Aspen moved to loosen restrictions on psychedelics on its own, some members worried that could make them targets of federal enforcement.

So instead of moving to independently enact a policy change, members could “informally” express support for “research to see what the benefits of these drugs are and how they can be used in therapy.” They could do that “by resolution or not,” the member said.

But in the end, there was no direction for council staff to write up a resolution. Several members said it would put too much of a workload on staff, and others said that formally promoting decriminalization could create complications for law enforcement.

Last year, the Colorado Springs City Council also talked about decriminalizing psychedelics—with the body’s president sharing a personal anecdote about psilocybin treatment for a relative who had cancer—but no action was taken at that meeting either.

Numerous other local governments have moved to stop criminalizing people over entheogens.

While the Aspen City Council might not be ready to unilaterally advance reform, numerous other local governments have moved to stop criminalizing people over entheogens since Denver became the first city in the nation to decriminalize psilocybin via voter initiative.

The Northampton, Massachusetts, City Council is the latest example, with members unanimously adopting a resolution last month to deprioritize enforcement of laws against the possession, use and distribution of a wide range of psychedelics such as psilocybin and ayahuasca.

Two other Massachusetts cities—Somerville and Cambridge—have also moved to effectively decriminalize psychedelics. Outside of that state, four other cities—Oakland, Santa Cruz, Ann Arbor and Washington, DC—have also decriminalized possession of plant- and fungi-based psychedelics.

In Oakland, the first city where a city council voted to broadly deprioritize criminalization of entheogenic substances, lawmakers approved a followup resolution in December that calls for the policy change to be adopted statewide and for local jurisdictions to be allowed to permit healing ceremonies where people could use psychedelics.

After Ann Arbor legislators passed a decriminalization resolution last year, a county prosecutor recently announced that his office will not be pursuing charges over possessing entheogenic plants and fungi—“regardless of the amount at issue.”

At the state level, the Texas House of Representatives approved to a bill last week that would require the state to conduct a study into the therapeutic potential of psychedelics like psilocybin and MDMA.

Meanwhile, two Senate committees in California have recently approved a bill to legalize possession of a wide range of psychedelics and create a working group to study broader reform.

Photograph via Drug Enforcement Administration

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on Twitter and Facebook, and sign up for its newsletter.

The post Aspen, Colorado, Lawmakers Pass Buck on Psychedelics Decrim appeared first on Filter.