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Federal Health Agencies Acknowledge Therapeutic Potential Of Psychedelics

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The heads of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) coauthored a new letter describing that status of research into psychedelic drugs such as psilocybin, LSD and ibogaine.

The letter, dated last week, also contains surprising admissions about the therapeutic potential of these federally prohibited controlled substances.

It comes in response to an inquiry from Sen. Brian Schatz (D-HI), who requested information about the government’s research agenda on investigating the medical value of psychedelics as well as any plans the agencies have to recommend rescheduling them under the Controlled Substances Act.

Psychedelics present an “opportunity to provide treatment to patients while expanding psychotherapy treatment options,” the senator wrote. “Studies have found the benefits of the controlled use of psychedelics in psychotherapy programs, including the benefits of lysergic acid diethylamide (LSD) to reduce anxiety for patients with life-threatening diseases, and the safety and efficacy of ketamine, MDMA, psilocybin, LSD, and ibogaine in clinical trials.”

While the agencies said they do not have plans to recommend reclassifying any psychedelics that are currently placed in the restrictive category of Schedule I, they acknowledged throughout their response that psilocybin, LSD, MDMA, ketamine and ibogaine hold therapeutic promise and can help uncover “mechanisms of illness and possible interventions, ultimately leading to novel treatments with fewer side effects and lower abuse potential.”

Ketamine is already an FDA-approved drug for treatment-resistant depression and is accordingly classified under Schedule III.

Federally funded research into LSD has also proved valuable, as scientists were able to observe its molecular structure bind to receptors in the brain, providing the “first structure-informed insights into the molecular mechanisms of a hallucinogen,” the FDA and NIH leaders said.

“In addition, these findings may hold clues to the roots of psychopathology and consciousness and may accelerate the discovery of new treatments for serious mental illnesses such as schizophrenia and depression,” they wrote.

There are ongoing clinical trials into MDMA, which may be able to treat symptoms of post-traumatic stress disorder and anxiety. Researchers are working to understand the mechanisms through which MDMA produces its psychoactive effects, and that information could be used to develop compounds “with improved safety or efficacy profiles and reduced abuse liability.”

Ibogaine is a bit trickier, the officials wrote. Earlier research has demonstrated that the naturally occurring compound can help treat opioid addiction and reduce cravings generally, but scientists have also identified significant health risks, including toxicity to nerves in the brain and muscles in the heart, they said. Because there’s a risk of fatality associated with using ibogaine, the agencies determined that it does not have therapeutic potential.

FDA and NIH also responded to a question from Schatz about gaps in scientific understanding that currently exist as it relates to psychedelics.

“Further research is needed to examine the efficacy and long-term safety of psychedelic drugs, including with repeated exposure and potential interactions with existing treatments,” they wrote. “It is also important to understand their mechanisms of action in order to identify new targets that preserve the therapeutic effect and minimize negative side effects.”

The letter goes on to describe the various benefits and risks of each psychedelic substance.

Ketamine can cause sedation and disassociation that is useful in some clinical settings, but it’s also proved addictive and can produce frightening hallucinations; LSD and psilocybin cause “intensified feelings and sensory experiences, and changes in the perception of time” but their long-term effects are unknown; MDMA shows promise in treating symptoms of certain mental conditions but withdrawal effects include irritability and sleep problems; ibogaine seems to “reduce craving and relapse in patients with substance use disorder,” yet it can also cause various health problems.

The letter concludes that FDA is “not currently recommending a transfer of any Schedule I psychedelic drugs to any of the schedules applicable for drugs having a currently accepted medical use in the United States,” but it stressed that research opportunities will continue to be made available and if studies demonstrate that any given psychedelic possesses proven medical benefits, it retains the authority to make a rescheduling recommendation.

The response from FDA and NIH comes amid a growing conversation around the country and in Congress about laws governing psychedelic substances. After Denver became the first city to decriminalize psilocybin in May, Oakland’s City Council followed suit and decriminalized multiple psychedelics including psilocybin, ayahuasca, mescaline and ibogaine.

This month, Rep. Alexandria Ocasio-Cortez (D-NY) introduced an amendment to remove a rider from a spending bill that inhibits research into controlled substances, and she pointed specifically to psilocybin and MDMA as examples of drugs that ought to be further investigated. Her amendment was soundly defeated on the House floor last week, however.

Read Schatz’s letter on psychedelics below:

Final Letter to NIH, FDA Re… by on Scribd

Read the response from FDA and NIH below:

Response From FDA and NIH R… by on Scribd

How Democrats Helped Republicans Shut Down AOC’s Psychedelics Research Measure

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Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Kyle Jaeger is Marijuana Moment's Los Angeles-based associate editor. His work has also appeared in High Times, VICE and attn.

Politics

Kentucky GOP Congressman Touts ‘High Hemp IQ’ Of His Constituents

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Rep. James Comer (R-KY) says that he proved his political advisors wrong when he decided to champion hemp legalization.

When he served as Kentucky’s Agriculture Commissioner before joining Congress and first contemplated “making hemp a reality,” he was told that people would conflate the crop with marijuana and he’d face a backlash, Comer said during an interview that aired this week.

“They said the people of Kentucky will never know the difference. They’ll think you’re talking about marijuana and you’re done,” he said during the Kentucky Educational Television appearance. “You can’t be a Republican and do this.”

“But people in Kentucky are smarter than some people give us credit for, and the people in Kentucky knew the history of hemp,” he said, noting that his own grandparents cultivated the crop.

“We have a high hemp IQ in Kentucky, and people across America are now learning the difference between hemp and marijuana.”

One of the areas that Comer said he hopes to see expanded is the use of hemp fibers to create products such as furniture and car parts. He mentioned one example of a Kentucky company that’s creating hardwood flooring out of hemp, and House Agriculture Committee Chair Collin Peterson (D-MN) is going to tour that facility with him soon.

Shortly before becoming the panel’s chair, Peterson said he was considering growing hemp on his own farm.

Most of the existing hemp facilities in Kentucky are producing CBD oil, which Comer said he also takes to treat minor pain.

While hemp and its derivatives were federally legalized under the 2018 Farm Bill, businesses are still awaiting guidelines from the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA). And that regulatory uncertainty has led some financial institutions to deny credit lines to hemp companies.

To that end, Comer said he and Senate Majority Leader Mitch McConnell (R-KY) are working closely to resolve the problem. That includes pushing for the Secure And Fair Enforcement (SAFE) Banking Act, which would protect banks that service state-legal cannabis businesses from being penalized by federal financial regulators.

“We teamed up with the marijuana people in the states,” Comer said.

Watch Comer’s hemp comments, starting around 5:30 into the video below:

“They’ve legalized marijuana. They’re selling marijuana. They’re not allowed to deposit the cash. They’re not allowed to take credit card transactions at those marijuana stores,” he said. “We have worked with them to try to create a system where you can have financial transparency, and that bill is making its way through Congress now.”

The SAFE Banking Act was approved by the House Financial Services Committee in March. And on Tuesday, the Senate Banking Committee took advocates by surprise after it announced that it would hold a hearing on marijuana banking issues next week, with just days left before the August recess.

Separately, the Senate Agriculture Committee will meet to discuss hemp production two days later.

McConnell has been an especially vocal advocate for hemp and CBD. For example, he led the head of USDA on a tour of a Kentucky hemp facility that produces CBD oil earlier this month.

Comer also claimed in the new interview that large pharmaceutical companies feel threatened by hemp-derived CBD as more consumers gravitate toward it as a “natural supplement” that could be a substitute for prescription painkillers.

“Now what you are having up here in Washington as we speak, the big drug companies are like, ‘Wow, people are buying this CBD oil and not buying our drug,'” the congressman said. “So they’re demanding that the FDA regulate it.”

He and McConnell are working to “keep the FDA off the backs of people,” Comer said.

While former FDA Commissioner Scott Gottlieb stressed that creating a regulatory pathway that allows for the lawful marketing of CBD as a food item or dietary supplement would take years without congressional action, the agency recently said that it is speeding up the rulemaking process and will issue a progress report by early fall.

USDA similarly recognized the intense interest from lawmakers and stakeholders in developing regulations for the crop, and it plans to issue an interim final rule for the crop in August.

Senate Schedules Second Cannabis Hearing For Next Week

Photo courtesy of KET.

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Psychedelics Decriminalization Moves Forward In Cities Around The U.S.

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Activists in Berkeley, California and Port Townsend, Washington took steps this week to get psilocybin mushrooms and other psychedelics decriminalized, following in the footsteps of successful similar efforts in Denver and Oakland.

In Berkeley, a decriminalization resolution advanced in a City Council committee on Wednesday, and organizers in Port Townsend spoke about their proposal at a county public health board meeting on Thursday, with plans to formally present it to the City and County Council.

The Berkeley measure would prohibit city departments and law enforcement from using any funds to enforce laws against possession, propagation and consumption of psychedelics by individuals 21 or older. Members of the City Council Public Safety committee unanimously voted to send the resolution to the body’s Public Health Committee for further consideration.

If that panel approves the measure, the full Council will schedule a hearing and vote on final passage. Decriminalize Nature, the group behind this resolution as well as the successful passage of neighboring Oakland’s psychedelics decriminalization effort last month, said they hope the Council will act on the measure by early November.

Separately, activists in Port Townsend announced that they delivered a speech about their psychedelics decriminalization proposal during a meeting of the Jefferson County Board of Health.

Beyond prohibiting the use of government funds to criminalize adults for using and possessing the substances, the local Washington resolution also calls on the city administrator to “instruct the City’s state and federal lobbyists to work in support of decriminalizing all Entheogenic Plants and plant-based compounds that are listed on the Federal Controlled Substances Schedule 1.”

“We are overwhelmed by the support of our community. Our group of supporters filled up half the audience,” the Port Townsend Psychedelic Society said in an Instagram post. “We are currently making plans to speak with the county health officer to talk about next steps in presenting in front of city and county council.”

Alex Williams, who is leading the decriminalization effort in Berkeley, told Marijuana Moment that Wednesday’s Council committee meeting there “went better than I had anticipated” and that he feels “there is an excellent chance of the resolution passing.”

Watch the Berkeley Public Safety Committee discuss psychedelics, starting at about 42:00:

While Williams said two members of the committee seemed to be under the impression that the resolution is singularly geared toward recreational use and meant to “capitalize on a new market,” Decriminalize Nature plans to address those misconceptions, emphasizing that the measure would not provide for commercial manufacturing or sales and that “this process is very important to allowing safe, equitable access to marginalized communities.”

“It is essential that entheogenic substances be treats as sacred spiritual practices and healers,” he added.

The resolution defines entheogenic substances as “plants and natural sources such as mushrooms, cacti, iboga containing plants and/or extracted combinations of plants similar to ayahuasca; and limited to those containing the following types of compounds: indoleamines, tryptamines, phenethylamines.”

Two Councilmembers, Rigel Robinson and Cheryl Davila, are sponsoring the measure.

“You can imagine a day where, years from now, doctors working with patients with serious depression or veterans dealing with PTSD could actually offer them a more realistic and comprehensive suite of potential treatments, which may include some of these plants as the research over the last several decades has indicated,” Robinson said at the meeting.

While Berkeley might seem like an obvious target for psychedelics reform given the city’s decades-long close association with counterculture, the movement to remove criminal penalties is gaining steam nationally. Decriminalize Nature is maintaining a map of jurisdictions throughout the country where activists have expressed interest in pursuing a similar model.

Also this week, a resident spoke at a Columbia, Missouri City Council meeting, asking the body to consider a resolution to decriminalize psychedelics. At least one councilmember expressed interest in following through, and he called the therapeutic potential of the natural substances “very promising.”

Individuals from nearly 100 cities have reached out to the organization for assistance advancing their own decriminalization efforts.

Voters in Denver kicked things off by approving the nation’s first-ever ballot measure to decriminalize psilocybin mushrooms in May.

Activists are currently pursuing efforts to place psilocybin-focused measures on statewide ballots in California and Oregon for next year.

More Than 100 Marijuana Businesses Urge Congress To Include Social Equity In Legalization

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Top Democratic Party Leader Flops With Attempted Joke About Trump Smoking Hemp

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The chairman of the Democratic National Committee (DNC) apparently thinks that hemp gets you high—and that getting high makes you dumb.

In an attempted dig at President Donald Trump, who said last week that farmers struggling amid a trade war were “over the hump,” DNC Chair Tom Perez said he thought the president “was smoking some hemp when he said they were over the hump.”

“If you smoke some hemp, I guess that would stimulate certain farm economies here,” he added during his remarks at a press conference in Wisconsin.

Watch Perez’s hemp comment at about 6:45 into the video below:

Because hemp contains only trace amounts of THC, the main psychoactive ingredient in marijuana, it wouldn’t get you high, as Perez implied. But legalization advocates say it’s especially problematic that a party leader is treating marijuana as a laughing matter in the first place.

“I would need to be smoking something a hell of a lot stronger than hemp to find Tom Perez’s weak attempt at a marijuana joke funny,” Erik Altieri, executive director of NORML, told Marijuana Moment.

“At a time when over 600,000 overwhelmingly black and brown Americans are still being arrested every year for simple possession, our failed and racist prohibition is no laughing matter,” he said. “While we have made great progress in winning elected officials nationwide to our cause, Perez illustrated that we have a lot of work left to do when it comes educating them about the issue and still a bit of a road to go down before we can stop dealing with dad jokes and bad weed puns.”

Don Murphy, director of federal policies for the Marijuana Policy Project, echoed that point.

“We need more leadership and action at the federal level, not more stupid jokes, puns and inaccurate comments about hemp’s ability to get you high,” he told Marijuana Moment. “Luckily that is something that many of his party’s presidential candidates understand,” he said. “Sadly, Mr. Perez does not.”

Perez’s position on cannabis policy isn’t quite clear, as he’s remained largely silent on the issue. In contrast, many 2020 Democratic presidential candidates are campaigning on broad marijuana reform proposals.

The DNC chair made his attempted hemp quip during a press availability in Milwaukee, where he is meeting donors and coordinating preparation for next year’s Democratic National Convention.

Senate Schedules Second Cannabis Hearing For Next Week

Photo courtesy of Flickr/Gage Skidmore.

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