According to the head of the Food and Drug Administration, exploring the therapeutic benefits of psychedelics like psilocybin and Ibogaine are a “top priorty” of the Trump administration. This is especially true when it comes helping veterans cope with the trauma of being sent into “unnecessary battles”.
One of the most recent examples is FDA Commissioner Marty Makary’s comments, which emphasize the need for “a rapid and expedited review” to achieve federal approval.
He said in an interview that was aired by NewsNation on Saturday, “I don’t believe we listen to patients when it comes to these psychedelics or other plant-based treatments.” “I do not think that the medical establishment pays attention to doctors. When I listen to the individuals who have tried some of these for real medical conditions—post-traumatic stress disorder, severe refractory depression—people tell me that they believe that psilocybin was successful. The psilocybin was curative or significant in helping their severe depression.
Other psychedelics like MDMA have also been reported to be helpful for treating PTSD. Makary told Makary that “doctors have said they’ve sent their patients to this therapy.” Ibogaine was used for treating PTSD. There are trials now looking at it for traumatic brain injury—things we have had nothing for in the past. How have we treated traumatic brain injuries and PTSD in the past?
The commissioner stressed that he’s not necessarily endorsing plant-based medicine at this stage because he wants to first ensure FDA collects data demonstrating their efficacy, but “we have to listen to doctors who have these experiences, and this is one of our top priorities at the FDA—to listen to doctors, to listen to patients and to make sure we don’t get in the way with red tape.”
We need to act quickly to find out what can help these young Americans who have been sent into unnecessary wars and suffered serious injuries. “We owe them everything to make sure we do the right thing and do an independent assessment,” said he, adding that psychedelics could benefit veterans with high mental health problems. This is the top priority of this FDA under this administration.
He said, “we must take a close look at all things.”
I think that everything should be discussed. I believe we should examine how we consider and evaluate these medications. Makary stated that “there are currently running clinical trials which will readout soon. This data must be reviewed quickly.” “We can’t say, ‘Well, our normal process is that it takes a year to give a good look at data.’ The situation is dire. And I don’t think—if these medicines end up showing clinical benefit in their trials—I don’t think it’s a silver bullet. “We owe the people in pain to take action as quickly as possible as a government.”
As FDA commissioner, Makary is uniquely positioned to advance the issue—by promoting research, facilitating approvals of new drug applications for psychedelics and taking steps to reschedule substances such as psilocybin and MDMA.
The Biden Administration saw a heightened interest in examining psychedelics. FDA provided novel guidelines for researchers in pursuit of possible approvals. However, the FDA ultimately denied an application for MDMA-assisted treatment for PTSD.
The current commissioner’s remarks also come in the context of a meaningful shift on psychedelics policy within this administration—with the secretaries of the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Health and Human Services (HHS) that oversees FDA also having expressed support for exploring the issue. Trump’s nominee to be the U.S. surgeon-general has spoken about her own personal experiences with psilocybin.
Last week, VA secretary Doug Collins boasted that he was “one of first” Secretaries to commit his agency’s resources towards exploring the use of psychedelics for potential therapies.
“What we’re seeing so far in some of the studies that are related to VA, and also outside of VA as well,” he told lawmakers during a House committee hearing, “is that there has been—especially when it comes to PTSD and also traumatic brain injury and others—we’re seeing some actual positive outcomes there, especially when it is coupled with intense counseling. It’s one thing that I look forward to.
Casey Means is the nominee of President Donald Trump to be the next surgeon-general. She has publicly spoken about her personal experience with psilocybin.
Meanwhile, Reps. Jack Bergman (R-MI) and Lou Correa (D-CA)—co-chairs of the Congressional Psychedelic Advancing Therapies (PATH) Caucus—introduced a bill last month to provide $30 million in funding annually to establish psychedelics-focused “centers for excellence” at VA facilities, where veterans could receive novel treatment involving substances like psilocybin, MDMA and ibogaine.
Bergman has also expressed optimism about the prospects of advancing psychedelics reform under Trump, arguing that the administration’s efforts to cut spending and the federal workforce will give agencies “spines” to tackle such complex issues.
Collins also recently met with a military veteran who’s become an advocate for psilocybin access to discuss the therapeutic potential of psychedelic medicine for the veteran community.
In a separate meeting with Trump, the Secretary informed him that the agency was “opening the possibility of psychoedelic treatments” for vets.
Also, during a Senate committee hearing this month, he separately reiterated his commitment to exploring the efficacy of psychedelic therapy to address serious mental health conditions that commonly afflict veterans.
Bipartisan congressional lawmakers have also asked the VA head to meet with them to discuss ways to provide access to psychedelic medicine for military veterans.
Collins said that last month, he and HHS Secretary Robert F. Kennedy Jr. had an “eyeopening” discussion about the potential for psychedelic medication. Collins also said that he is open to having vouchers provided by the government to pay for psychedelic therapies for veterans receiving services from outside the VA, as Congress looks at pathways to access.
In December, VA separately announced that it’s providing $1.5 million in funding to study the efficacy of MDMA-assisted therapy for veterans with PTSD and alcohol use disorder (AUD).
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