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
New Hampshire Lawmakers Approve Marijuana Legalization Bill
A New Hampshire House committee approved a bill on Tuesday that would legalize marijuana for adult use in the state.
While the legislation doesn’t provide for retail sales, it would allow individuals 21 and older to possess and gift up to three-fourths an ounce of cannabis and grow up to six plants. The model would be similar to neighboring Vermont’s non-commercial cannabis system.
The Criminal Justice and Public Safety Committee advanced the bill in a 13-7 vote.
“I think that the legalization of cannabis is more popular than the legislature itself or the governor or any other political entity in the state of New Hampshire,” Chairman Renny Cushing (D) said prior to the vote. “This is something that the people of the state of New Hampshire want. They don’t want to be treated like they’re criminals if they have a plant.”
Watch New Hampshire lawmakers discuss the marijuana legalization bill below:
This vote comes a week after the panel held a hearing on the proposal, with advocates and stakeholders testifying in favor of the reform move.
“Like most Granite Staters, this committee understands that it’s time for New Hampshire to stop prohibiting cannabis,” Matt Simon, New England political director for the Marijuana Policy Project, said in a press release. “Adults in the ‘Live Free or Die’ state should not be punished for their choice to use a substance that is objectively less harmful than alcohol.”
“Now that New Hampshire is literally surrounded by jurisdictions where cannabis is legal for adults, our current policies can no longer be justified in any way,” he said. “It’s time for the House, Senate and Gov. Chris Sununu to work together and move cannabis policies into the 21st century.”
A floor vote by the full House of Representatives is expected on February 6.
Tax-and-regulate marijuana legislation has advanced in the legislature in prior sessions, but it never arrived on the governor’s desk.
Even if it did make it that far, however, it’s unclear if Sununu, a Republican, would sign it. He’s voiced opposition to commercial legalization, and he vetoed a bill last year that would’ve allowed medical cannabis patients to cultivate their own marijuana, raising questions about whether he’d be willing to support this latest measure extending that right to all adults over 21.
In any case, the New Hampshire development comes amid a flurry of legislative activity around cannabis in the Northeast.
New York Gov. Andrew Cuomo (D) included legalization in his budget last week, as did Rhode Island’s governor, who pitched a state-run cannabis model in her plan. In New Jersey, the legislature approved a referendum to put the question of recreational legalization before voters during the November election. Top lawmakers in Connecticut are also confident that marijuana reform will advance this year. In Vermont, advocates are hopeful that lawmakers will add a legal sales component to the state’s current noncommercial cannabis law.
Photo courtesy of Philip Steffan.
AOC Says Colorado Is Doing A ‘Great Job’ With Marijuana Legalization
Rep. Alexandria Ocasio-Cortez (D-NY) says Colorado is an example of a state that’s effectively taxing and regulating marijuana.
At a town hall event in Iowa on Saturday, the congresswoman, who serves as a surrogate for Sen. Bernie Sanders’s (I-VT) presidential campaign, was asked if revenue from legal sales of cannabis and other drugs would be used to fund the senator’s Medicare for All proposal.
While she said the economic benefits of legalization are secondary concerns, she acknowledged that “Colorado is doing a great job of taxing it to fund schools.”
That said, funding large programs such as universal health care would require a diverse financing strategy, Ocasio-Cortez said.
“In terms of financing, I think the financing for our health care program would potentially come from different sources,” she said. “Senator Sanders has outlined how he would pay for Medicare for All.”
“I would just say the financing is a different question,” she said. “But when it comes to decriminalization and legalization, I know that the senator believes in the legalization of marijuana and, frankly, having that part of a decarceral approach” to the criminal justice system.
Listen to the conversation below, starting around 1:45:
“We need to not only have a conversation about decriminalization and a conversation about legalization, but we need to have a conversation about the harm done during the war on drugs,” she said in comments that were first flagged by The Washington Post’s Dave Weigel.
First actual Q for AOC as a Sanders surrogate: Would she legalize drugs to pay for M4A?
"The funding is going to come from a lot of sources," she says, clarifying that Sanders supports legalizing only marijuana and is focused on ending war on drugs.
— Dave Weigel (@daveweigel) January 25, 2020
“It exacerbated the racial wealth gap in America as well,” she said. “But not only that, it tore apart communities, it tore apart families and it was an explicit targeting of black and brown communities that dates back to the Nixon administration.”
“On one hand it’s an economic issue, but much deeper, it’s a justice issue. This is an issue of justice, this is an issue of mass incarceration. The United States has historically incarcerated more people per capita than any other country in the world. We need to live up to our values about what ‘Land of the Free’ means and transitioning to that means dismantling the system of mass incarceration. That’s an incredibly important part of this agenda.”
While Sanders has been a long-standing champion of cannabis reform, his views on broader drug policy proposals diverge from those of his surrogate, who believes that possession of all currently illicit drugs should be decriminalized and federal laws around psychedelics should be loosened to promote research.
Despite being widely regarded as the most progressive candidates in the race, both Sanders and Sen. Elizabeth Warren (D-MA) have so far declined to back comprehensive decriminalization for simple drug possession, a policy changed favored by former South Bend, Indiana Mayor Pete Buttigieg.
Rep. Tulsi Gabbard (D-HI), another 2020 contender, recently said that she’s in favor of legalizing and regulating controlled substances.
Photo courtesy of C-SPAN.
USDA Approves Hemp Plans For Texas, Nebraska And Delaware
The U.S. Department of Agriculture (USDA) announced on Monday that it has approved hemp regulatory plans for three more states and four additional Indian tribes.
This is the latest in a series of approvals that USDA has doled out since the crop and its derivatives were federally legalized under the 2018 Farm Bill. Texas, Nebraska and Delaware—in addition to the Colorado River Indian Tribes, the Fort Belknap Indian Community, the Iowa Tribe of Kansas and Nebraska and the Yurok Tribe—each had their regulatory plans cleared.
“USDA continues to receive and review hemp production plans from states and Indian tribes on an ongoing basis,” the department said in a notice. “Plans previously approved include those for the states of Louisiana, New Jersey, and Ohio, and the Flandreau Santee Sioux, Santa Rosa Cahuilla, and La Jolla Band of Luiseno Indian Tribes.”
While hemp is no longer a federally controlled substance, farmers interested in cultivating and selling the crop must live in a jurisdiction where USDA has approved a proposed regulatory scheme. The process was outlined in an interim final rule USDA published late last year. If a state or tribe does not have, or plan to propose, regulations for hemp, cultivators can apply for a USDA license instead.
“This is a victory for Texas farmers,” Texas Agriculture Commissioner Sid Miller said in a statement. “We are one step closer to giving our ag producers access to this exciting new crop opportunity.”
“We’ve got to get our rules approved and get our licensing program up and running, but the dominoes are dropping pretty quick,” he said. “We’re almost there.”
Heather Fazio, director of Texans for Responsible Marijuana Policy, told Marijuana Moment that “Texas has the potential to be the largest supplier of hemp in the U.S., providing farmers with an unprecedented opportunity.”
“With approval from the USDA and the Texas Department of Agriculture already moving forward with establishing licensing standards, it’s refreshing to see our government paving the way for legal cannabis cultivation in Texas,” Fazio said.
While lawmakers and industry stakeholders have widely celebrated USDA’s commitment to implementing hemp legalization, it has also received a significant amount of pushback over proposed rules such as THC limits and laboratory testing requirements. A public comment period for the department’s interim rule ends on Wednesday.
USDA maintains a website that tracks the status of state and tribal hemp plans.
Monday’s announcement sends another signal to the hemp industry that the federal government is committed to supporting the market and ensuring that farmers have the resources they need to see their businesses thrive since the crop was legalized.
That said, one of the most lucrative market opportunities that hemp farmers are hoping to take advantage of is the widespread interest in hemp-derived CBD products. The Food and Drug Administration (FDA) has jurisdiction over rules for marketing CBD, and the agency has made clear that the process may take several years without congressional action.
Earlier this month, a bipartisan coalition of lawmakers set out to do just that, filing a bill that would require FDA to allow CBD products to be sold as dietary supplements.
Photo courtesy of Brendan Cleak.