Daily Archives: June 29, 2017

After the 1970s Controlled Substance Act criminalized all psychedelics, there was a long period of silence in US psychedelic research. That has changed in the last 20 years; since 2002, as many as 26 studies were approved, including landmark research on MDMA-assisted therapy for veterans suffering PTSD. But with President Donald Trump in office, is the resurrected research movement in danger?

The people really calling the shots are those far closer to Trump than those running the FDA.

It depends. Two agencies are crucial for the burgeoning field: the US Food and Drug Administration and the Drug Enforcement Agency. Some researchers see the Trump FDA as potentially helpful, since new commissioner Scott Gottlieb has made statements in favor of scaling back regulations. Other researchers are leery of the DEA. Thats because the DEA is overseen by the Department of Justice under the supervision of Jeff Sessions, who has requested that Congress allow him to prosecute marijuana cases in states that have legalized medical marijuana. Its not yet clear which agency will set the psychedelic agenda, and increased enforcement action from the Justice Department could scare scientists away from the field.

I do feel very optimistic," says Rick Doblin, executive director of psychedelic research nonprofit MAPS, a leading funder of psychedelic research. "One of the Trump administration's main things is lower regulation. They're pro business and pro making it easier for Big Pharma to get drugs through the FDA. And that benefits us."

But the FDA isnt as far up the food chain as other influential agencies. DEA licenses are required for psychedelic research. And Trump has given Attorney General Sessions plenty of leeway in drug policy, says Erik Altieri, executive director of marijuana-focused nonprofit NORML. It seems that the people really calling the shots are those far closer to Trump than those running the FDA, says Altieri. The proof will be in the pudding here about who actually sways Trump's opinion, and what he will be willing to tolerate.

Psychedelics remain Schedule 1. They are categorized among a class of substances purported to have no medical application and high risk of abuse, and bearing the harshest penalties for recreational use. Any clinical use of psychedelics in the US must go through a rigorous DEA licensing and FDA approval process.

Many researchers hope that the FDA will maintain the framework developed by a unit called Pilot Drug Evaluation Staff, which first greenlit pilot studies with psychedelics in the early 1990s. Before, the FDA had denied approving or shelved research protocols with psychedelics. But in large part because of practices established by Pilot Drug, like expedited drug review and direct scientist-to-scientist communication between researchers and the FDA, psychedelic research restarted, and has only gained momentum since.

The FDA is fairly apolitical, says psychedelic research chemist and pharmacologist David Nichols. He is the president of the Heffter Research Institute, which has funded 12 FDA-approved clinical psychedelic studies since Pilot Drug. Congress would have to push to change that, and he doesnt believe that will happen. We're just a flea on the back of this dog.

Though the FDA is more friendly to psychedelics than ever before, getting the approval to test compounds is a long and complicated process. Doblin hopes that Trumps FDA commissioner Scott Gottlieb will simplify it, thanks to a key Trump administration talking point: deregulation. Gottliebs public statements endorse cutting regulatory processes in favor of quickened drug approvals though he hasnt specifically addressed psychedelic research.

But deregulation has risks. Regulations are not arbitrary rules; each is set in place for a specific reason. They are designed to reduce risk during studies and prevent harm to patients after drugs go to market. The unintended consequences [of deregulating] would require so much wisdom on the part of the people making the changes to be staggering, says Dan Spyker, a former medical officer for the FDAs Pilot Drug and deputy division director. You can't just say, 'Well, I'm going to cut the regs.' It's complicated.

Jag Davies, director of communications strategy at Drug Policy Alliance, agrees. Overall I would be more concerned about the danger of erasing our food and drug safety standards than excited about the possibility of easier psychedelic research, says Davies. I don't think ultimately that's a good thing.

Another federal department has begun to set an increasingly conservative tone towards illicit drugs under Trump: the Department of Justice, which oversees the DEA.

Attorney General Jeff Sessions renewed drug war highlighted by his two-page memo ordering DOJ staff to pursue harsher sentences for drug offenders, and by his pitch to Congress that the DOJ should be allowed to prosecute medical marijuana providers has already given drug reform advocates new reason to worry. We've really stepped into mass mobilization of preparing for the worst, quite frankly, says NORMLs Altieri.

Marijuana is not a psychedelic, and yet its subject to even stricter research regulation. In addition to the requisite DEA and FDA sign-offs, the National Institute on Drug Abuse must supply the cannabis for all studies. Marijuana is legal in eight states and permitted for medical use in 30, so a hardline stance on marijuana is likely to chill all research on illicit drugs, says Altieri. Psychedelics arent legal anywhere, so getting approval for a drug like psilocybin might seem like a bigger ask to regulators, he says.

Historically, Health and Human Services which supervises FDA defers to the DOJ when it comes to drug policy, says Davies. For instance, during Bill Clintons presidency, HHS secretary Donna Shalala proposed federally funded needle exchanges a harm-reduction program. Drug czar Barry McCaffrey overruled her. Psychedelics researchers must obtain DEA licenses to conduct their studies; if Sessions wants to block drug research, he can make the license application process harder, Davies says.

Though researchers know more than ever about psychedelic drugs and some studies have found promising potential uses for them none of the research renaissance has translated into law enforcement policy. These laws target people of color and low-income communities, and mandate incarceration for possession. Sessions is unwilling to consider research suggesting medical marijuana may actually help some people; it is unlikely hell push for any kind of reform for psychedelics, either. And hes taken a hard line on sentencing.

MAPSs Doblin thinks MDMA will be made legal for prescription use, in tandem with psychotherapy, by 2021. But, he adds, I can feel both optimistic, and it's still a long road ahead. He views Sessions hard line on sentencing as the other sort of counterpoint to his optimism.

Despite their working relationship with the FDA, researchers are fearful that a Sessions-led Justice Department might undo all the progress made since the 90s.Its just so scary Jeff Sessions and the drug war, and that we would go backwards after all this work and money, says Ann Mithoefer, co-therapist on the ongoing MDMA-assisted psychotherapy and PTSD studies funded by MAPS, alongside her husband Michael. Even Doblin acknowledges that the overarching political climate is very negative.

Mithoefer and Doblin continue to place their trust in the FDA, even though the DOJ is becoming more hostile. A May 11th meeting with the FDA about the Mithoefers MAPS-funded MDMA Phase 3 protocol was beyond positive, Doblin says. We came to an agreement on all the elements of the studys design.

The biggest challenge for the study right now isnt federal regulation. Its fundraising. Most US voters dont support legal medical use of most illicit drugs, so funding is difficult. And thats one final place where Trump administration policy may bog down psychedelic research.

The Trump administration tends to make decisions about mental health care and substance abuse treatment without consulting the body of scientific literature thats built up over the decades. Trumpcare restricts access to mental health care and substance abuse treatment programs. Thats because the highest priority appears to be budget cuts. So Gottliebs hands-off rhetoric might not mean much, since HHS secretary Tom Price is more interested in defunding his department than deregulating it. Trumps proposed budget for 2018 has a 16.2 percent cut for HHS.

Psychedelic research has never received government grants from HHS departments, relying instead on donors to nonprofits like MAPS and Heffter. So, the current administrations intent to slash the US science budget wont matter there. But if more scientists have to find private funding to continue their work, psychedelics may no longer be a priority for donors.

Thats a setback. In fact, Heffters Nichols had hoped the recent surge in compelling clinical data would encourage HHS to lend its funding support to psychedelic research. The studies are expensive; they can cost more than a million dollars. But if independently funded work had shown enough benefits, Nichols thought, it seemed possible that government funding might be forthcoming. That hope died when Trump took office.

"The funding will be the biggest problem, Nichols says. I don't see legal problems, I don't see clinical problems so much. The real problem I see is what the proposed Trump budget would do, not just to psychedelic research, but to biomedical research in general. And it would be a real disaster."

Stephie Grob Plante is the daughter of Charles Grob, a clinical psychedelic researcher and Heffter board member. He was not consulted for this story.

Original post:

The war on drugs is back. Will psychedelic drug research survive? - The Verge