Psychedelics reform is uniting even the most unlikely allies: Reps. Alexandria Ocasio-Cortez (NY-14) and Dan Crenshaw (TX-02) are making some progress despite a few setbacks in House committees. 

“This is a real wild coalition,” Crenshaw said, Fox News reports. Ocasio-Cortez, aka AOC—the youngest woman to serve in Congress and a progressive firebrand—and Crenshaw—former Navy SEAL and conservative voice—both have pushed for similar psychedelic provisions in the past despite agreeing on little else on the political spectrum.

Friday the H​​ouse Rules Committee advanced the National Defense Authorization Act (NDAA) with psychedelics research language previously attached in the House Armed Services Committee, however voted to block floor consideration of an amendment to expand provisions and restore original language which was whittled down.

Reps. Ocasio-Cortez, Crenshaw hosted a press conference on July 13, recognizing progress with a provision in the NDAA that directs the Secretary of Defense to conduct a clinical report on psychedelic treatment in military treatment facilities. The two were joined by Rep. Lou Correa (D-CA) at the press conference.

Crenshaw first voted against the provision in the NDAA on the floor to protest the Rules Committee blocking his amendment, but he swapped his vote to a “yes” vote after the stipulation from leadership that they would try to restore his original language.

Early research shows promising results for the use of psychedelics in treating post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI), among other conditions. In previous years, both representatives have separately introduced amendments to the NDAA to allow for the medical study of psychedelics. This year, a version of their amendment language was included in the original bill text for the NDAA. 

Psychedelics Research Looks Promising

“Psychedelics have shown so much promise,” said Ocasio-Cortez. “We desperately need the resources to treat PTSD, traumatic brain injury and depression. At least one in two PTSD patients cannot tolerate or do not respond adequately to existing treatments.”

The need for novel treatments to tackle PTSD and other conditions is growing.

New York Daily News reports that PTSD is now double for Iraq and Afghanistan vets, compared to what it was for Vietnam vets, according to the Department of Veterans Affairs (VA), and data from the Centers for Disease Control and Prevention indicates that more than 450,000 U.S. war fighters suffered TBI from 2000 to 2021.

Crenshaw said House Speaker Kevin McCarthy (R-CA) will support the amendments and said they will get added when the Senate and House meet to iron out the differences between the defense bills.

For the Congressman, the reasons are personal: Crenshaw lost his eye when an I.E.D. explosive nearly took him out while serving a tour in Afghanistan.

The psychedelics portion of the bill was previously attached to the House Armed Services Committee bill, and it would call on the Defense Secretary to launch a clinical study into the therapeutic benefits of psilocybin, MDMA, ibogaine, or DMT.

The original amendment would increase funding for clinical trials on the therapeutic benefits of psychedelics for military members with PTSD, TBI, or CTE. However, the amendment was modified to remove key language around funding and clinical trials, making it less effective.

The House Rules Committee, however, rejected an amendment that would have restored the original language of the amendment. 

“I know the power of this community to rise up and make itself heard,” Ocasio-Cortez added.

The original language of the legislation could be restored when the NDAA amendments go before negotiations with the Senate.

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AOC is doing what we love her best for: calling out the old-guard Democrats. Alexandria Ocasio-Cortez, the Democratic Representative from New York, says she’s worried that President Joe Biden may derail bipartisan efforts to address psychedelics due to his past conservative comments about cannabis usage, Business Insider reports. 

“I believe the president has displayed a regressiveness for cannabis policy,” she said, making it clear that she has concerns about Biden’s approach to cannabis and psychedelics. “And if there’s a regressiveness toward cannabis policy, it’s likely to be worse on anything else,” AOC added. 

Cannabis and “classical” psychedelics, such as LSD and psilocybin, have been gaining the American people’s public acceptance. In June, a study found that Americans say cannabis is much less dangerous than opioids, alcohol, and cigarettes. 

Recently, during an interview with The Michael Smerconish Program on SiriusXM Wednesday, the president’s brother, Frank Biden, shared that the president might be down with psychedelics. “He is very open-minded,” Frank Biden responded when asked by Smerconish about discussions with his presidential brother about the medical benefits of psychedelics.” 

In 2022, Biden announced that he will pardon people with federal convictions for simple possession of cannabis. The president also announced that he will direct the U.S. Attorney General Merrick B. Garland and Secretary of the Department of Health and Human Services Xavier Becerra to begin the process of reviewing the classification of cannabis at the federal level.

And, in late June, the FDA issued the first-ever guidance for psychedelic clinical studies. They filed the 14-page document following Congress-introduced bipartisan legislation led by Texas Republican Representative Dan Crenshaw, directing the issuance of clinical trial guidelines. 

However, this hasn’t convinced AOC that President Biden, the leader of the federal government, is committed to honoring the public’s changing viewpoints based on how he has talked about marijuana in the past. “I am concerned about the president,” Ocasio-Cortez of New York told The Washington Post. 

And she’s not wrong to question his flip-flopping policy. Back during the 2020 election, Leafly pointed out that Biden was the only Democratic presidential candidate that was against federal legalization. Only a few years ago, in 2019, Biden said cannabis could be a “gateway drug,” one of the foulest expressions in the English language to the cannabis connoisseur. 

“The truth of the matter is, there’s not nearly been enough evidence that has been acquired as to whether or not it is a gateway drug,” the then-presidential hopeful said during a town hall event. “It’s a debate, and I want a lot more before I legalize it nationally. I want to make sure we know a lot more about the science behind it.”

However, once Biden realized it was only him and Donald Trump against federal legalization, he quickly changed his tune. Since entering office, he has kept a safe distance from drug policy but, as mentioned, has stated that federal legalization is in the future. However, Ocasio-Cortez says other lawmakers’ reactions regarding pro-psychedelic legislation tells another story. 

According to AOC, when she first introduced the legislation, an unnamed senior member of her party laughed at her. “Oh, is this your little ‘shrooms bill?’” Ocasio-Cortez said the lawmaker told her. She and Crenshaw added amendments that would increase access to psychedelic treatments for veterans and active-duty service members with mental health conditions, which were tacked on to the annual National Defense Authorization Act.

Florida Republican Representative Matt Gaetz, who recently proposed ending drug testing for the military, says the congressional “gerontocracy” is why lawmakers of both parties (the psychedelic movement is a surprisingly bipartisan effort), in line with AOC’s observation that politicians like Biden, are stuck in regressive viewpoints. 

However, even if Biden came off as anti-cannabis just four years ago, and even if that’s how he feels, given recent activity, it’s clear that he’s realized that if the president wants to stay in the game, he must embrace cannabis and psychedelics as valid medicines. Most folks in the movement would take federal deregulation, even if it comes from lawmakers’ efforts to look cool rather than what lives in their hearts. 

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The United States Food and Drug Administration, aka the FDA, issued the first-ever guidance for clinical studies on psychedelics, according to a news release issued Friday. They filed the 14-page document shortly after Congress introduced bipartisan legislation led by Texas Republican Representative Dan Crenshaw, directing the issuance of clinical trial guidelines.

They aimed the guidance specifically towards classical psychedelics, which include psilocybin, LSD, mescaline, and DMT, the psychoactive ingredient in ayahuasca, in addition to entactogens or empathogens such as MDMA. This means that it does not cover other drugs used therapeutically embraced by the psychedelic community, such as ketamine, which is technically a dissociative anesthetic that has hallucinogenic effects.

While the FDA guidance is new, research on the benefits of psychedelics is not. Applied Clinical Trials reports that there are currently 163 Phase I, II, or III studies on clinicaltrials.gov involving psychedelics. For instance, in January, MAPS Public Benefit Corporation, a biopharmaceutical company dedicated to psychedelic treatment, announced its Phase 3 clinical trial on MDMA-assisted therapy for post-traumatic stress disorder (PTSD) produced promising results.

“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer of MAPS Public Benefit Corporation. MAPS plans to submit the new drug application to the FDA in the third quarter of 2023.

Like MAPS’ study on MDMA, psychedelic research to date has primarily been backed by private sponsors. Many of these may want nothing to do with the Feds and their infamously regressive views on psychedelics. The FDA approval process is expensive and riddled with red tape. Many companies may prefer to follow state guidelines and leave psychedelics, such as psilocybin, which researchers currently study for OCD, and alcohol use disorder, nestled in the safety of libertarian-esque gray areas. (Oregon and Colorado are the only states to decriminalize the supervised use of psychedelics). 

For example, let’s look at ketamine, which, as noted, is not technically a psychedelic. While Esketamine, or S-ketamine, the S enantiomer of ketamine, is FDA-approved as a nasal spray, many ketamine clinics and psychiatrists prefer to prescribe patients actual ketamine, off-label, because it’s not only more affordable but may work better than the version the FDA approved, which was only changed to S-ketamine in the first place so Johnson & Johnson could patent it under the brand name Spravato. 

However, if a substance earns FDA approval, it is easier to market and sell and could reach more consumers who trust that it’s met the FDA decision that the benefits outweigh the risk. For instance, Tryp Therapeutics is currently seeking FDA approval for psilocybin-assisted therapy to help those with irritable bowel syndrome (IBS).

While such studies show that psychedelics hold great therapeutic potential, as anyone with personal experience using psilocybin, MDMA, or other psychedelics can attest, the FDA asserts that they must address the challenges associated with designing clinical studies to evaluate the safety and effectiveness of psychedelics.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry at CDER.1, Applied Clinical Trials reports. 

The guidance addresses the psychoactive and hallucinogenic effects of psychedelics, the potential for abuse, and the importance of conscientious safety measures. It includes considerations for the importance of characterizing dose-response and the durability of any treatments. The draft also tackles potential drug interactions for patients on antidepressants or mood stabilizers such as lithium. 

Additionally, for any Schedule I controlled psychedelics, the FDA states that the research must comply with applicable Drug Enforcement Administration (DEA) regulatory requirements. 

It also tackles the role of psychotherapy within a psychedelic treatment, what folks in the community often describe as integration, or the therapeutic process of a patient going through therapy with a professional to integrate their experience into everyday life, ensuring that it’s not just a one-time trip, but an ongoing treatment plan. 

If anyone has thoughts on the draft guidance, the FDA accepts public comments for 60 days. 

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