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
Bernie Sanders Asks Campaign Rally Audience To Share Stories About Marijuana Arrests
Sen. Bernie Sanders (I-VT) asked an audience in South Carolina to share stories about marijuana possession convictions and then argued that those anecdotes help to demonstrate the case for national legalization.
During a campaign stop in the early primary state on Sunday, the 2020 Democratic presidential candidate asked people to raise their hands if they knew someone who’d been arrested for possessing cannabis. There was no shortage of hands raised.
“Holy God, whoa. That’s a lot of people,” Sanders said before asking for volunteers to go into detail.
“I got caught with about a joint and they took my license for a year and I lost my job,” an audience member said. “Ended up losing my house, and it went worse from there.”
The War on Drugs has been a disaster. It is time to legalize marijuana nationwide. pic.twitter.com/tehuM7xjxx
— Bernie Sanders (@BernieSanders) September 17, 2019
“Wow, this is for smoking a joint?” Sanders asked.
“Yeah, I had a little—like a dime bag in my car,” the person said.
Another person in attendance who appeared in the campaign video Sanders released on Tuesday said that she visited a guilty plea court and witnessed “three different men get put in at least two years of prison just for anywhere from two grams to eight grams of marijuana found on them.”
“That’s why all over this country states are doing the right thing and either decriminalizing or legalizing the possession of marijuana,” Sanders said to applause.
Since becoming the first major party presidential candidate to call for cannabis legalization in 2015, Sanders has continued to place an emphasis on the need for marijuana reform, with a focus on the racial injustices of prohibition.
Last month, he released a criminal justice reform plan that included proposals to legalize cannabis federally and also provide for safe injection sites to curb opioid overdoses.
But while Sanders has been a leading voice in the drug policy reform movement, he’s said twice in recent weeks that he’s not ready to embrace decriminalizing possession of drugs beside marijuana.
Photo courtesy of Lorie Shaull.
New York Gov. Cuomo Hints Marijuana Smoking Ban Could Be Part Of Next Legalization Push
New York Gov. Andrew Cuomo (D) seemed to suggest that he might want a ban on smoking marijuana included in legalization legislation when lawmakers take up the issue again next year.
During an interview with MSNBC on Sunday, the governor was asked whether the spike in apparent vaping-related lung injuries and deaths, which experts attribute to altered nicotine and cannabis oils primarily purchased on the illicit market, has made him reconsider pursuing legalization in the state.
“No,” he said, adding that his administration is “not in favor of smoking marijuana” and that there are “ways to get THC without smoking marijuana.”
“People are vaping THC, yes that is true,” Cuomo said. “We think that from a public health point of view, that is not something that we recommend and we think it’s dangerous—smoking of any kind.”
“You can legalize marijuana and sell THC in compounds that do not require you to smoke the marijuana, and we do not support smoking of marijuana,” he said. “There are compounds that have the THC, which is a compound in marijuana, that you don’t smoke.”
It’s not entirely clear if Cuomo plans to ask for a smoking ban the next time a legalization bill emerges or if he was simply outlining an administrative position advising against smoking. A spokesperson for his office did not respond to Marijuana Moment’s request for comment by the time of publication.
But while there was no ban on marijuana smoking included in legalization legislation that he worked to pass earlier this year, it wouldn’t be entirely out of character given that he pushed for such a restriction as part of New York’s medical cannabis program in legislation enacted in 2014.
The logic behind that policy, according to Cuomo, was that it would prevent people from abusing the program. If he moved to incorporate a ban for adult-use legalization, however, it would presumably be a public health decision.
That could create problems when lawmakers return to the negotiating table. In California, flower and concentrates represent about 70 percent of the marijuana market, meaning any attempt to ban smokeable cannabis will likely be met with pushback from consumers, industry stakeholders and civil liberties-minded reform advocates.
Industry players seemed to have influence when Cuomo included a ban on home cultivation for personal use in his prior legalization proposal—something a major medical cannabis association recommended in a policy statement submitted to the governor.
For the time being, however, there don’t seem to be tangible plans to include a smoking ban in future cannabis legislation and it could be that the governor simply ends up pushing for public education campaigns discouraging the activity rather than keeping it illegal.
In July, he signed legislation broadening New York’s decriminalization law and creating a pathway for expungements for individuals with prior cannabis convictions.
Photo courtesy of MSNBC.
Mitch McConnell Tells FDA To Clear A Path For CBD Products Though Spending Bill Directive
Senate Majority Leader Mitch McConnell (R-KY) is moving to insert language into a congressional spending report that calls on the Food and Drug Administration (FDA) to clear a path for the lawful marketing of hemp-derived CBD products.
FDA has said that allowing CBD to be sold as food items or dietary supplements would require it to develop alternative regulations that could take years to complete without congressional action. But McConnell, who was the chief proponent of a hemp legalization provision of the 2018 Farm Bill, isn’t interested in waiting around.
In draft language shared by the U.S. Hemp Roundtable on Tuesday, the senator is asking FDA to “issue a policy of enforcement discretion with regard to certain products containing CBD” within 120 days—a move that industry stakeholders say will clarify rules so that banks are more willing to service CBD companies.
🚨 BREAKING FDA UPDATE 🚨 After close work with the U.S. Hemp Roundtable, @senatemajldr Mitch McConnell submitted legislation urging the FDA to take action on CBD. Visit the link in bio to take action! pic.twitter.com/zMohlD3NiS
— US Hemp Roundtable (@HempRoundtable) September 17, 2019
The provision of the spending report was marked up in the Senate Appropriations Subcommittee on Agriculture on Tuesday. It will go before the full Appropriations Committee on Thursday.
Prior to issuing its enforcement discretion policy under McConnell’s report language, FDA would have to submit a report to the committee within 90 days detailing its “progress toward obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products.”
Once those provisional enforcement guidelines are established, they would remain in place until FDA finalizes the regulatory process.
“FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug (IND) application in the development of a regulatory pathway for CBD in products under the jurisdiction of FDA and to ensure that any future regulatory activity does not discourage the development of new drugs,” the report states.
Outside of McConnell’s proposal, the FDA and U.S. Department of Agriculture (USDA) appropriations legislation already sets aside $2 million to support research and regulatory activities surrounding hemp-derived CBD products and $16.5 million for the broader hemp production program.
During the subcommittee meeting on Thursday, Sen. Jeff Merkley (D-OR) praised the bill’s support for hemp legalization implementation.
“You might note that this year in Oregon, the hemp industry may well be a billion dollar crop, and that is an incredible addition to income for our agricultural community,” he said.
The legalization of hemp and its derivatives has been met with intense interest from manufacturers and lawmakers alike, but limitations on the marketability of CBD has been an ongoing source of frustration.
Last week, a bipartisan pair of lawmakers asked fellow House members to join them in signing a letter to the head of FDA that similarly asks for enforcement discretion guidelines allowing companies to sell CBD products.
The House, which approved its version of appropriations legislation for the upcoming fiscal year prior to the summer recess, included a separate amendment that would require FDA to establish rules providing for the lawful marketing of CBD in food and dietary supplements.
Meanwhile, USDA is expected to soon release its broader hemp regulations soon.
Read McConnell’s full CBD report language below:
“As previously mentioned, the Committee provides $2,000,000 for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the Food and Drug Administration which contain cannabidiol (CBD) and meet the definition of hemp, as set forth in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o). Within 90 days, FDA shall provide the Committee with a report regarding the Agency’s progress toward obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products. Within 120 days, FDA shall issue a policy of enforcement discretion with regard to certain products containing CBD meeting the definition of hemp as defined by section 297A of the Agricultural Marketing Act of 1964 (7 U.S.C. 1639). Such enforcement discretion shall be in effect until FDA establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product. FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug (IND) application in the development of a regulatory pathway for CBD in products under the jurisdiction of FDA and to ensure that any future regulatory activity does not discourage the development of new drugs.”
This story was updated to include comment from Merkley.
Photo courtesy of Senate Majority Leader Mitch McConnell.