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Wednesday, Jul 28, 2021
Mugglehead Magazine
Cannabis & psychedelics industry news based in Vancouver, B.C.
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Policy

Positions of NIH, FDA signal we’re ‘on the brink of a psychedelic revolution’

The psychedelic movement is no longer about anecdotes, experts say

Heads of major health regulators are acknowledging the potential of psychedelic medicine. Photo via Numinus Wellness
Heads of major health regulators are acknowledging the potential of psychedelic medicine. Photo via Numinus Wellness

Public statements from federal health directors and breakthrough-therapy designations from the U.S. FDA in support of psychedelic medical research signal that clinical use of these mind-expanding substances is at a tipping point, experts say.

During a Senate subcommittee meeting last month, National Institutes of Health director Dr. Francis S. Collins said as researchers learn more about how the brain works, they’ve begun to realize psychedelics are potential tools for medical research. This is the first time the head of an American regulator has publicly acknowledged psychedelics as possible treatments for some mental illnesses.

“The positions of the Food and Drug Administration (FDA) and NIH are clear indications that we are on the brink of a psychedelic revolution, which I believe will provide the window to understanding the brain and consciousness on a much deeper level,” says Florida attorney Dustin Robinson in an email.

Robinson is the founding partner of Mr. Cannabis Law, a full-service law firm exclusively focused on the cannabis and psychedelic industries.

The psychedelic legalization movement is no longer an anecdote, but a fact backed up by compelling research data, he explains.

Read more: 67% of PTSD sufferers drop diagnosis in first MDMA Phase 3 trial

Read more: FDA lifts ban on study of therapists taking MDMA

Federal and state-level psychedelics movements set to collide

Robinson says there are two separate movements in the U.S. on a collision course.

“At a federal level, there has been an explosion of research and clinical trials for psychedelic medicines that are going through the proper federal pathways — FDA drug approval,” he says, adding the FDA has designated MDMA and psilocybin as “breakthrough therapies,” signaling acceptance at a federal level.

Dustin Robinson, founder of Mr. Cannabis Law and co-founder of Mr. Psychedelic Law. Submitted photo

The second movement involves states and municipalities decriminalizing, legalizing and beginning their own research programs — similar to the cannabis industry where businesses operate under local frameworks but violate federal law.

Both movements are picking up tremendous momentum, notes Robinson. As more research gets published on the efficacy of these compounds, the more ammo activists will have to further their cause.

To the north, Canada is establishing itself as a leader in psychedelic research with federal exemptions being granted for psilocybin treatment and pilot clinical programs, as well as special licences awarded for companies for research and development.

Read more: Numinus to test natural psilocybin safety in Phase 1 trial

Read more: Canada’s first set of approved health workers begin psilocybin therapy training

NIH director acknowledges potential of MDMA, LSD, ketamine, cannabis

During the Senate meeting, health director Collins brought up psilocybin, saying the classic psychedelic is now being tested in at least three research trials for depression, “and it is showing a signal thereof potential interest.”

Collins also mentioned he’s aware of trials with MDMA and LSD, while acknowledging the benefits of ketamine for people with major depression.

The discussion touched on how there’s been progress in advancing medical cannabis research. Collins identified a lack of federally approved sources of pot and scheduling of the plant as the main barriers for researchers.

Positions of NIH, FDA signal we're 'on the brink of a psychedelic revolution' - researchers Numinus

Numinus Wellness Inc. in Canada is running a Phase I clinical trial to test the safety and efficacy of natural psilocybin. Press photo

Collins proposed a new drug classification called “Schedule I-R,” which he describes as a different pathway to access illegal drugs for research.

In early April, the White House released its science-friendly budget proposal, which includes launching the Advanced Research Projects Agency-Health with a budget of USD$6.5 billion in 2022.

The new agency’s mission includes furthering advanced medical research in cancer, Alzheimer’s disease, diabetes, non-opioid painkillers and mental health.

Marking the 50th anniversary of the war of drugs on June 17, a recent poll showed 83 per cent of Americans deemed it a failure.

Read more: 83% of Americans deem war on drugs a failure and support new approach, poll shows

Read more: US DEA set to authorize potent pot production for research

 

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