The Future

Trump has been... good?... for psychedelic drugs???...

Well, this is a trip: Psychedelics are getting more research and consumer market approval than ever under this administration, thanks to benign neglect.
The Future

Trump has been... good?... for psychedelic drugs???...

Well, this is a trip: Psychedelics are getting more research and consumer market approval than ever under this administration, thanks to benign neglect.

Towards the end of 2016, some researchers and boosters of psychedelic drugs were starting to worry about the newly elected Donald Trump. For about a decade, psychedelic science had enjoyed something of a renaissance, with academics seriously reexamining and finding new medicinal potential in a host of substances from ayahuasca to LSD to MDMA, slowly shifting mainstream social views on these long-illicit drugs. And during the 2016 presidential campaign, it had seemed like neither Trump nor Hillary Clinton would oppose their fast developing and promising work.

The closer Trump got to November 2016, though, the more he adopted War on Drugs rhetoric. After his election, Trump surrounded himself with hardcore drug warriors, chief among them the fact-resistant, Reefer Madness-prone then-Attorney General Jeff Sessions, who was eager to take on the legalization of weed, a much more established project of medical re-exploration and social legitimation. Sessions led the Drug Enforcement Agency which, alongside the FDA, basically controls researchers’ abilities to access psychedelics. “We had some anxiety about what would happen,” said David Nichols, a retired Purdue University chemist who studied and synthesized psychedelics from 1969 on. “Could he do things that would throw [research] off the tracks?”

As neither Trump or any of his hirelings ever spoke out directly against psychedelics it is not a total shock that his administration has not gone after research in the field. But it’s remarkable that psychedelic science has actually flourished under the Trump administration. Not only have studies continued apace, but the FDA also granted a MDMA-assisted PTSD therapy “Breakthrough Therapy designation” status in August 2017, an official classification that recognizes its promising potential when compared to treatments already on the market and expedites agency reviews. In October 2018, the agency granted Breakthrough status to a psilocybin-assisted therapy targeting treatment-resistant cases of depression, now undergoing trials, as well. And this March, the FDA approved the (highly restricted) sale and use of a ketamine-derived nasal spray for the treatment, in conjunction with oral antidepressants, of treatment-resistant depression.

Some of this is probably just a result of the uninterrupted trajectory of that psychedelic science renaissance. But despite many researchers’ faith in the unstoppable progress of their work, the Trump administration could have conceivably put a real wrench into that trajectory. Instead, one can convincingly argue that the Trump presidency has granted — directly or indirectly — researchers more leeway and less friction than was expected, and perhaps more than a liberal administration might have.

Researchers, some with federal backing, first explored the potential of substances like LSD and psilocybin to treat mental health issues from addiction to schizophrenia in the 1950s and ‘60s. But their studies were poorly designed and they often overhyped results. The use of these substances outside of the lab by counter-culture types, as well as horror stories about bad trips and misinformation about the risk of addiction they carried, mixed with Nixonian and Reaganite War on Drugs fervor all but shuttered and buried this workwell into the ‘90s.

Slowly, researchers dusted off older findings, figured out how to jump through regulatory hoops to study these tightly controlled substances, and found new sources of funding. In 2006, as the journalist Michael Pollan notes in his 2018 book How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence, researchers finally published “the first double-blind, placebo-controlled clinical study in four decades—if not ever—to examine the psychological effects of a psychedelic,” offering new legitimacy to the field and truly kicking off its renaissance.

In the years that followed, researchers at various high-caliber universities launched dozens of studies on the psychological effects and potential therapeutic value of LSD, psilocybin, ketamine, MDMA, ayahuasca, ibogaine, and many more illicit psychedelic substances. Consensus slowly emerged that ketamine could be useful in alleviating treatment-resistant depression; just a little psilocybin could reduce anxiety and depression in terminally ill cancer patients; and MDMA-assisted therapy could help people with treatment-resistant post-traumatic stress disorder ([all with minimal]  ( side-effects, if any).

A new clinical trial would make MDMA not only easier to research, but potentially accessible as a prescription drug.

In 2016, the Food and Drug Administration designated a ketamine depression treatment a Breakthrough Therapy. It also approved a Phase III clinical trial for MDMA-assisted PTSD treatment, the results of which could pressure the federal government into moving the substance out of Schedule I, the category for controlled substances with no perceived medical value, low safety, and high abuse risk. That would make MDMA not only easier to research, but potentially accessible as a prescription drug.

“We’re living in a really interesting time,” said Nichols. “I thought that I would be dead before things got this far.”

Many psychedelic researchers believe that there was never really any risk that Trump could have jammed up their ability to get approvals for research through the FDA. Sure, before the 1990s, some researchers argue that the FDA all but shelved most applications to study these substances. Now, though, argues Ekaterina Malievskaia of Compass Pathways, the company leading the psilocybin trials that got Breakthrough status last fall, “the FDA, and many other regulators around the world are approaching this research … as they would any other research.” Nichols describes it as a body full of apolitical scientists whose operations and standards can’t really be shaken by some new administration’s top-down attitude.

“The big questions were about, were there things he could do at the Drug Enforcement Agency,” said Nichols, as that is a more political body, full of people who have skeptical attitudes towards studies that try to find value in the illicit substances they police. It would have been unprecedented, he said, for anyone to directly interfere with established fields of research through the DEA.

Sessions, whom Trump ousted in November 2018 likely over investigations into Russian meddling in the 2016 elections, could have slow-walked applications for licenses to study psychedelics. He could have upped the degree of paperwork and verification researchers had to go through, tried-and-true Trump-era approaches to frustrating activities it doesn’t like but can’t shut down completely. He also could have directed resources towards cracking down on therapists who use psychedelics in off-the-record, underground work, ginning up conservative fears about connections between psychedelic research and illicit activities.

“There could have been some right wing Congressmen or Senators who could have called over to the FDA and said, what are you doing?” said Nichols. Enough concerted political pressure could have forced, say, a review of approval processes and standards at the FDA (scaring bejeezus out of institutions that support psychedelic researchers), or even led to a new law restricting research further.

Fortunately, neither Sessions nor any like-minded regulators or legislators have thus far gone after psychedelic science. Sessions and Trump prioritized immigration and had their hands full with ongoing investigations into Russian campaign meddling. Charles Grob, a professor of psychiatry and behavioral science who has researched psychedelics at the Harbor-UCLA Medical Center since the ‘90s, told me his sense is that psychedelic research “is still going under the radar, unlike in the ‘60s, when it was very prominent on the center stage.”

An administration that offered proactive support to psychedelic science, instead of just benign neglect, could have triggered backlash.

Paradoxically, Grob suggested, an administration that offered proactive support to psychedelic science, instead of just benign neglect, could have triggered backlash. “Hillary Clinton,” said Grob, “was a lightning rod for contrarians who would reflexively want to refute anything she would say. She would say, we need more research to investigate the range of effects of marijuana, and her detractors were reflexively responding, no, we should not have more research on this. Getting Hillary Clinton out of the picture probably helps in the long run” for all manner of Schedule I substances research, he said.

“The less the administration says and does surrounding Schedule I drugs,” Brad Burge of MAPS, the organization behind the Breakthrough-designated MDMA-assisted PTSD therapy trials, told me, “the more they become a scientific issue, and the less a political issue.”

Yet fear the Trump administration might act against psychedelic research early on, Burge argued, did lead to a blitz in donations to organizations like MAPS. “This goes not just for MAPS,” he said, “but for all nonprofits in the country: The election and the administration seem to have encouraged a new wave of public support. MAPS [and its work] has certainly benefited from that.”

Beyond benign neglect, some in the psychedelic-science world suspect that Trump’s penchant for deregulation could benefit their work. In early 2017, Trump considered tapping Jim O’Neill, the managing director of Peter Thiel’s Mithril Capital hedge fund, to lead the FDA; O’Neill had previously advocated allowing substances onto the market once they were proven safe, not once they were proven to work for their intended purposes. Trump eventually settled on the less-radical Scott Gottlieb, a big-pharma insider  who has stressed the importance of speeding up drug-approval processes and perhaps allowing more flexible clinical-trial design standards. (Gottlieb left the FDA in March 2019 for reasons that remain unclear. He was recently replaced by National Cancer Institute Director Norman Sharpless, whose positions on regulation are not yet as clear as Gottlieb’s were.)

This deregulatory push has made public health advocates nervous, as they believe it could lead patients down unproductive, or counterproductive, treatment paths, possibly putting their health at risk. There does not seem to be any real evidence of Trumpian policies at the FDA leading to negative outcomes in the pharma world. (Recent reports on literally millions of deaths and injuries caused over the years by FDA-cleared yet lightly regulated medical implants suggest advocates’ fears are not unfounded; critics have also made fair cases that Trump-era FDA deregulation precipitated last year’s big lettuce-based E. coli outbreak.)

In mid-2017, MAPS founder Rick Doblin  argued that Gottlieb’s deregulatory attitude could make it easier to get approvals to test psychedelic compounds. And Burge acknowledged that a Trumpian FDA might make it easier to secure Breakthrough status to “accelerate the research a year or two at the most, and maybe cut $5 million from the total cost” of a Phase III MDMA trial. Nichols said that while it is impossible to know for sure, Compass and MAPS may have gained their Breakthrough designations due to Gottlieb’s policies. Grob, however, told me he doubts deregulation will have much, if any, effect on psychedelic research.

The Trump administration has done nothing to directly benefit psychedelic science. It is also difficult to parse out whether benign neglect and deregulation have given any tangible boost to research projects, or if such projects would have advanced through FDA oversight just as easily under another administration thanks to their merits and the sheer momentum that the field of psychedelic science has built up in recent years. Many researchers and observers put great stock in the power of that momentum and downplay the possible effects Trump and his team have had on the field.

Nichols said that the evidence of the benefits of psychedelic therapies is so strong that even hardcore anti-drug conservatives wouldn’t push hard against it even if they had the bandwidth to do so, and might even get aboard the psychedelic-therapy bus. In seeming support of that view, the Breitbart- and Trump-backing Mercer family donated $1 million to MAPS about a year ago to support its Phase III clinical trial of MDMA-assisted PTSD therapy.

“It’s an evolutionary process,” said Nichols, but psychedelic research “is going in the right direction, and I don’t see any way [any potential opponents to it] could really stop it at this point.”

One should never doubt the ability of political resistance to derail logically sound forward momentum.

But one should never doubt the ability of political resistance to derail what seems like logically sound and technocratically-backed forward momentum. If nothing else, the Trump administration has been a master class in just how fragile the status quo can be, no matter how seemingly old or solid it is, and in the creation of policies that completely disregard facts and science. The administration certainly could have been a disaster for psychedelic research. Instead, it has instead created a haven of benign neglect.

This could all change, especially if Trump manages to stay in power past the next election. In 2021, MAPS expects to complete its big Phase III MDMA trial. This will likely kick off a push to lobby the DEA to reschedule it; a similar push may soon follow for psilocybin. This may put a greater focus on this research, prompting more direct political discussion.

“If you had a really anti-drug Jeff Sessions leading the DEA,” said Nichols, “there could be some questions about how easy it would be” to get rescheduling done. Even before then, Trumpian efforts to hack and slash at government research funding could tank any potential for funding from the National Institutes of Health for this sort of research — and divert private funding from psychedelics to formerly NIH-backed, freshly defunded work.

Any number of other complications could upset progress in psychedelic research as well. For now, we can all be thankful that the Trump administration has created, inadvertently or not, an unexpectedly fruitful field for this work. “I really hope,” Nichols said, “that nothing puts up an obstacle we haven’t anticipated.”

Mark Hay is a freelance writer based in Brooklyn.