FDA creates path for psychedelic drug trials

Federal regulators are laying out guidance for psychedelic drug trials for the first time, in a move that could encourage the mainstreaming of substances like magic mushrooms and LSD as behavioral health treatments.

Why it matters: Psychedelics are turning into a multi-billion industry and gaining widespread acceptance after decades of concerns about recreational use of the products — and the high risk for misuse. But research to date has largely been backed by private sponsors.

Driving the news: The Food and Drug Administration on Friday released first-ever draft guidance outlining considerations — including trial conduct, data collection and subject safety — for researchers looking into psychedelic treatments for a variety of conditions, including PTSD, depression and anxiety.

  • The agency filed the 14-page document two days after a bipartisan coalition in Congress led by Rep. Dan Crenshaw (R-Texas) introduced legislation directing the issuance of clinical trial guidelines.
  • It also came as 10,000 attendees and hundreds of exhibitors converged on Denver for what was billed as the “largest psychedelic conference in history,” with guests ranging from New York Jets quarterback Aaron Rodgers to National Institute of Mental Health director Joshua Gordon.

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Immigrants Can’t Naturalize if They Own a Marijuana Dispensary, Court Says

Running a state-legal marijuana dispensary is grounds to deny a legal resident’s application for U.S. citizenship, a federal appellate court ruled earlier this month.

The 9th Circuit Court of Appeals concluded that Maria Elena Reimers’ application for naturalization could be denied because she operates a licensed marijuana business in Washington state. While her business is legal under Washington law, marijuana remains illegal under the federal Controlled Substances Act (CSA).

The court affirmed that violating the CSA “categorically precludes her from qualifying for naturalization” since it demonstrates a lack of “good moral character.” The ruling rejected Reimers’ claim that she is treated differently than marijuana business owners who are U.S. citizens. Washington has licensed almost 500 marijuana dispensaries since legalizing recreational sales in 2012.

Reimers has no criminal record, yet in a letter announcing the denial of her naturalization application, U.S. Citizenship and Immigration Services (USCIS) described her as an “illicit trafficker of a controlled substance.”

“We have a legal business and pay taxes, tons of taxes to the government. And yet they say I’m not morally fit to be a citizen,” Reimers tells Reason.

Reimers immigrated legally to the U.S. from El Salvador in 2004 with her now-husband Rick, who was born in the United States. Rick started Cannarail Station, a recreational dispensary in Ephrata, Washington, in 2014. Reimers submitted her naturalization application in May 2017, fully disclosing her involvement with the business.

After her initial interview in August 2017, Reimers says she passed the naturalization test and was scheduled for an oath ceremony. Then USCIS changed her application to pending. In June 2018, she appeared for a second interview, where immigration officers extensively questioned her about the business. Reimers testified honestly that she was a co-owner and employee of Cannarail Station.

In July 2018, Reimers received a denial letter from USCIS. In May 2019 she had an appeal hearing with USCIS, but a year later they reaffirmed the decision. Reimers filed a complaint in the U.S. District Court for the Eastern District of Washington in December 2020, which granted summary judgment to USCIS in February 2022 solely on the basis of her marijuana business. She appealed the decision to the 9th Circuit, which heard the case in April 2023.

Her attorney, Alycia Moss, tells Reason, “She’s qualified in every other way. The only denial reason was based on lack of ‘good moral character.'”

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Ron DeSantis Says He Would Not Decriminalize Marijuana If Elected President

Florida Gov. Ron DeSantis (R), a 2024 GOP presidential candidate, said he would not federally decriminalize marijuana if elected to the White House—arguing that cannabis use hurts the workforce, inhibits productivity and could even lead to death if contaminated.

At a campaign event in South Carolina on Thursday, a person who said they were representing wounded veterans asked DeSantis if he would “please” decriminalize cannabis as president.

The governor responded directly: “I don’t think we would do that.”

He then talked about Florida’s medical marijuana program that was enacted by voters, saying veterans are “actually allowed access” to cannabis under that model. But he said the issue is “controversial because obviously there’s some people that abuse it and are using it recreationally.”

DeSantis rattled off a number of concerns he has about cannabis use, starting with the potency of marijuana that “they’re putting on the street” and his understanding that illicit products are being laced with other drugs such as fentanyl.

“If you do something with that, it could be goodnight right then and there,” he said. “You could die just by ingesting that, so I think that that’s problematic.”

Experts and advocates have questioned law enforcement claims about the prevalence of fentanyl-tainted cannabis in the illicit market. In any case, DeSantis also didn’t acknowledge that creating a regulatory regime where marijuana is subject to testing before consumers can buy it could mitigate instances of contamination.

“I think that we have we have too many people using using drugs in this country right now. I think it hurts our workforce readiness. I think it hurts people’s ability to prosper in life,” he said, adding that people he knew in high school who used marijuana “suffered.”

“All their activities, all their grades and everything like that—so particularly for the youth, I just think we have to be united,” the candidate said. He also plugged a Florida program overseen by his wife that involves sending athletes to schools to warn students about “the stakes of using some of these drugs nowadays, and this is not something you want to mess around with.”

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Philadelphia Considers Zoning Restrictions on Still-Illegal Recreational Pot Shops

Recreational marijuana isn’t legal yet in Pennsylvania. That hasn’t stopped Philadelphia politicians from trying to future-proof their zoning ordinances to block recreational sales.

Philadelphia Councilmembers Brian O’Neill and Curtis Jones have proposed amendments to the city’s zoning code that would preemptively prohibit existing medical marijuana businesses in two overlay districts they represent from participating in recreational sales.

The prohibition would affect five existing medical marijuana stores, according to The Philadelphia Inquirer, which reported on the zoning amendments earlier today.

The immediate practical impacts of the amendments are minimal, given that recreational marijuana is still illegal in Pennsylvania. State lawmakers are nevertheless working on various proposals for legalizing recreational sales. Gov. Josh Shapiro, a Democrat, has endorsed legalizing (and heavily taxing) recreational sales.

Industry advocates say this will unfairly penalize existing medical marijuana businesses when recreational sales are eventually legalized, all because they opened up in the wrong part of town.

“If you set up a system where four or five stores can’t sell adult use and then 16 can, people are going to go to the ones” that can sell to recreational customers, says Jamie Ware, president of the Pennsylvania Cannabis Coalition (a trade association).

Ware is also a senior vice president with Holistic Industries which operates one of the Philadelphia dispensaries that would be affected by O’Neill and Jones’ zoning amendment.

Existing businesses, she notes, are locked into longer-term commercial leases, so they can’t easily move to avoid the restrictions. If the current medical system is any guide to how future recreational businesses will be regulated, transferring a license to a new location would require state approval and could take years.

O’Neill did not immediately respond to Reason‘s request for comment. Jones told the Inquirer that while medical sales haven’t created problems, recreational sales will bring a less desirable crowd, necessitating the restrictions.

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SFO United Staff Accused of Stealing Marijuana From Checked Bags

A group of United Airlines employees stole marijuana from checked luggage at San Francisco International Airport (SFO) for years, according to federal prosecutors. The Justice Department charged two baggage handlers on June 9 with conspiracy to distribute a controlled substance for their role in the alleged scheme.

The employees, Joel Lamont Dunn and Adrian Webb, allegedly enlisted at least three other airport workers to help them snatch the cannabis, load it into 15-20 gallon trash bags and then put it in their personal vehicles, according to court filings.

The attorneys for Dunn and Webb did not reply to requests for comment by publication time.

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Perceived Stigma of Cannabis Patients

A June 2022 study entitled “Perceived Stigma of Patients Undergoing Treatment with Cannabis-Based Medicinal Products” that was published in the International Journal of Environmental Research and Public Health explored the potential impact of stigma on medical cannabis patients.

The study’s authors noted that “it is well documented that stigma can reduce utilization of healthcare services and can negatively impact treatment.” They reported that stigma can also lead to chronic stress and anxiety, “in addition to subsequent mental and physical problems that can cause individuals to feel isolated and withdrawn.”

Perceived Stigma of Cannabis Patients. “While there is a growing body of evidence on the associated effects of cannabis-based medicinal products on health-related quality of life in several health conditions, there is a paucity of knowledge on the prevalence and subsequent effects of stigma on current and prospective patients” in the United Kingdom, reported the study.

The study observed that “evidence from countries which have greater experience with medical cannabis therapies shows stigma to be a factor in both prescribing practice and patient perception.”

The study observed that “evidence from countries which have greater experience with medical cannabis therapies shows stigma to be a factor in both prescribing practice and patient perception.” Interviews of Canadian patients revealed that the most common sources of stigma were “health care providers, law enforcement, and close relatives.”

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Psychedelic drugs like LSD could enhance the effects of brain simulation

New research provides evidence that LSD alters the effects of brain stimulation and produces different and potentially larger changes in brain activity. The preliminary findings suggest that psychedelic drugs and brain stimulation may have a synergistic effect that could be used in innovative ways for treating various conditions. The proof-of-concept study has been published in the journal Psychedelic Medicine.

Psychedelic-assisted psychotherapy has shown promising potential as a therapeutic approach for various mental health conditions. This treatment combines the use of psychedelic substances, such as psilocybin or LSD, with psychotherapy sessions to enhance the therapeutic process.

The psychedelic substances used in this type of therapy are known to induce altered states of consciousness, leading to profound experiences that can have therapeutic benefits. These substances are thought to work by affecting brain receptors, particularly the serotonin 2A receptor, which influences perception, mood, and cognition.

These drugs have also been found to enhance neural plasticity, which refers to the brain’s ability to reorganize and form new connections. This may contribute to their long-term therapeutic effects. It is believed that combining psychedelic drugs with therapies like psychotherapy or brain stimulation could help direct these neuroplastic changes and lead to lasting behavioral changes.

“Current treatments like transcranial magnetic stimulation (TMS) have a large potential to help people with a variety of psychiatry disorders, however, these neuromodulatory treatments tend to have relatively short-lived effects,” explained study author Lucas Dwiel, a postdoctoral fellow at The Doucette Lab at the Geisel School of Medicine at Dartmouth. “So if we could prolong the effects of these treatments by first using drugs like LSD to make the brain more malleable or susceptible to change, we could help a large number of patients achieve their therapeutic goals.”

The researchers conducted experiments using rats to eliminate the biases inherent in human studies. The study focused on the effects of LSD and involved two main components: measuring brain activity changes after LSD administration and assessing the effects of brain stimulation combined with LSD.

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Why Does Alabama Only Let You Consume Peach-Flavored Edibles?

Alabama, which legalized medical weed back in 2021, is just now getting around to licensing cultivators, testing labs, processors, transporters, and dispensaries so qualifying patients can begin to have access. The catch? You can’t smoke it, and all the edibles you consume must be peach-flavored.

You see, if the edibles are cube-shaped (also stipulated by law) and peach-flavored, they’re somehow less likely to interest kids—at least that’s the state Senate’s logic after a heated floor debate, according to Alabama Reflector‘s Brian Lyman (and the new regulations).

“At one point the bill said it would have no taste, but (state Sen. Tim) Melson said that would cause people to gag. So the compromise was a single flavor,” Lyman told AL.com. “Maybe peach isn’t as attractive to people?”

This isn’t the first time lawmakers have used “for the children” justifications to attempt to regulate which products adults may legally buy. For over two decadesReason‘s Jacob Sullum has documented the assaults on malt liquor, clove cigarettes, and any other vice that might possibly excite the taste buds of minors. In 2020, the Food and Drug Administration banned flavored e-cigarette cartridges to “combat the troubling epidemic of youth e-cigarette use,” ignoring the many surveys in which ex-smokers report that flavored vape cartridges actually helped them quit smoking tobacco cigarettes. And the Alabama case isn’t the first time the kid safety justification has been used to justify the regulation of edibles.

Maryland regulators, who took forever to get their medical cannabis scheme off the ground, were further delayed back in 2019 because they needed to develop rules governing the appearance of edibles “to ensure the safety of minors.” (“I don’t want to deprive anyone of their medication, but let’s treat this like medicine, not make little gummy bears out of it,” said Republican state Sen. Robert Cassilly at the time.) New York has banned the marketing and advertising of cannabis products “designed in any way to appeal to children or other minors.”

In 2014, Colorado regulators deliberated over whether to ban practically all edibles before ultimately allowing a broader variety, but disallowing those shaped like animals, people, or fruit (which are also banned in California). In 2018, Washington state regulators mulled rules that would have banned certain shapes of edibles—along with the use of icing and sprinkles—before ultimately just banning the use of bright colors; per the authorities, product colors must fall within a “standard pantone color book that sets the list of colors and specified ranges within those colors.”

“If you go through a [New York] cannabis dispensary right now,” Columbia University epidemiologist Katherine Keyes told the Associated Press, “it’s almost absurd how youth-oriented a lot of the packaging and the products are.”

Lawmakers, regulators, and public health worrywarts are aided and abetted by a willing media. “Consumption of Marijuana Edibles Surges Among Children, Study Finds,” reads a New York Times headline from earlier this year. “3,000+ young children accidentally ate weed edibles in 2021, study finds,” adds NPR. (Though any accidental ingestion that results in hospitalization is worrying, no children died in any of the thousands of cases analyzed in the study—a not-insignificant point that few journalists pointed out.)

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It’s the Summer of 2023, and Cannabis Remains Federally Illegal. What’s Happening?

It was big news last fall when President Joe Biden pardoned federal offenders who had been charged and convicted of federal cannabis possession.

For over 50 years, since President Richard Nixon signed the 1970 Controlled Substances Act, cannabis has been a Schedule I federally controlled illegal drug, classified just like heroin and LSD.  Yet, Biden’s pardon proclamation did not make cannabis federally legal. However, tucked into Biden’s 2022 executive order was something no president to date has done: Biden directed the Secretary of Health and Human Services and the Attorney General to “review” the legal classification of cannabis.

No formal announcement on the status of that review has been made since then.

Just two months after issuing the 2022 pardon proclamation, Biden also ramped up cannabis research expansion by signing into law the 2022 Medical Marijuana and Cannabidiol Research Expansion Act. This legislation opened up even more federal research by finally streamlining the approval process for the federal scientific studies. For the first time in American history, there now exists a cannabis medical study law that requires the U.S. attorney general to review medical study proposals within a 60-day period or request that applicants provide additional information. As of yet, though, there’s no real sense of the impact this legislation has had on actual medical cannabis research.

Before these presidential moves, the medical research of cannabis’s health benefits was almost solely the province of the states. In fact, Pennsylvania, which legislatively legalized in 2016, was the first state to require medical cannabis research as part of its medical legalization regime. Since then, other states like California and Colorado have established state-sponsored research programs, but Pennsylvania remains the nation’s first to select and pair state universities with cannabis producers to collect data and study cannabis’s efficacy. 

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S.F. Mayor Breed defends controversial move to arrest drug users: ‘You’ve never lived in it’

Mayor London Breed fiercely defended her controversial policy to arrest and detain drug users to get them into treatment against criticism from Supervisor Dean Preston on Tuesday, calling him a “white man who’s talking about Black and brown people as if you’re the savior.” 

Breed has directed the Police Department to use public intoxication laws to arrest people who are high on drugs, detain them to sober up in jail and then offer them services. So far, officers have cited or arrested 38 people under the so-called “Intoxication Detention Program,” 12 of whom already had arrest warrants issued against them, she said during the Board of Supervisors meeting Tuesday. Breed said none accepted drug treatment upon release. 

Preston pushed back on the approach Tuesday. He pointed out that Breed approved her health department’s overdose prevention plan in September that said Black, brown and Indigenous people continue to be impacted by “the racism and criminalization that have been the hallmark of federal U.S. drug policy for the past several decades.” 

The plan says “punitive policies have not been shown to be effective at reducing overdose deaths, while incarceration is known to significantly increase risk of dying of drug overdose” and cites a study demonstrating an increased risk of fatal overdose after incarceration. 

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