Independent experts have given a scathing assessment to a psychedelic therapy for PTSD. Nevertheless, some members of Congress are pushing for its approval.

Former Marine Corps General 77 years old has become an unlikely advocate of treating veterans with post-traumatic disorder using the psychedelic ecstasy.

Jack Bergman, a Republican, is a former helicopter pilot in Vietnam. He has three stars and now represents a district in northern Michigan in the House. He is a Republican who sees potential in psychedelics. A group of mostly psychiatry faculty members who advise the FDA did not. They recommended that the FDA reject a pharmaceutical company’s application to provide MDMA with therapy for PTSD.

Bergman has joined a group of lawmakers who have military connections, Elon Musk the mogul, doctors, investors, and supporters of drug legalization in a bid to convince the FDA to ignore its advisors. The FDA plans to announce its decision by the end of this week.

Bergman said that “every day that passes without research, more lives are lost, mostly to suicide.” Bergman said, “A lot veterans are on dark paths.” He then shaped his fingers in the shape of a pistol and pointed them at his own head.

Every day that passes without research, more lives are lost, mostly through suicide. Many of those veterans have a dark future ahead.

Rep. Jack Bergman

A rejection by the FDA of Lykos’ MDMA-based talk therapy application could slow down the growing psychedelic movement. Drug companies are also studying other psychedelics as potential treatments for mental health. However, a positive response would encourage more research. The opposition of the advisors, coupled with the lobbying from legislators and their allies outside the agency will raise concerns among doctors that the FDA has bowed down to pressure.

Lykos has taken steps to allay the concerns of its advisers.

This week, the company revealed that it would be establishing an independent board of experts on corporate and medical ethical issues, innovation, psychiatry and veteran and military health to oversee its potential commercial launch.

The FDA rejects new drug applications quite often, but only about a third overrules their advisors.

Bergman and his allies, motivated by the suffering he witnesses among veterans with PTSD are “gently yet positively” urging the FDA to approve Lykos. Bergman is leading a group of 50 senators and representatives who are urging the FDA to approve Lykos’ application.

Bergman explained that “the strategy is to apply pressure in a way that encourages the bureaucracy to feel comfortable taking some risks.”

Bergman was at a Capitol Hill press event with Rep. Lou Correa, the other founder of Congressional Psychedelics Advancing Therapies Caucus. He also stood alongside Reps. Jimmy Panetta, a former Navy Intelligence officer whose father Leon once headed the Defense Department and Morgan Luttrell, a retired Navy Seal who has used psychedelics to treat the trauma he suffered from a training incident. A tombstone prop was filled with dog tags of veterans who had committed suicide. The FDA was urged to “follow science” in the inscription.

The lawmakers cited Lykos, a company that provided therapy to people who had PTSD and took MDMA. They said most of these patients no longer met diagnostic criteria.

They saw things differently. The FDA’s advisers found that the treatment was ineffective and its risks were greater than its benefits. Lykos was criticized for not providing safety data, misbehaving therapists and a psychedelic-evangelistic culture.

Lykos’s approval is important to the lawmakers who support it. Bergman and Correa led the effort in Congress to include provisions in funding bills that promoted psychedelics for the VA and Defense Department. They have told veterans who tried everything else, psychedelics can help.

Searching for new treatments

Psychedelics, long regarded as party drugs and counterculture, are now being given a second look due to the belief that they can treat mental disorders, which affect more than one quarter of Americans. They also have a potential for treating dissatisfaction over existing treatments.

According to federal data, in 2021 there will be 14,5 million adults with at least one episode of major depression and 13 millions people with PTSD. Veterans are disproportionately impacted.

The traditional PTSD treatment, like selective serotonin reuptake inhibiters, such as Zoloft or Paxil, that cause the brain release the mood-altering serotonin chemical, is often ineffective, and weaning them off can have unpleasant side effects.

The psychedelics that are already being used include ibogaine derived from an African bush, 5-MeO DMT which is derived from the Colorado River Toad and psilocybin also known as magic mushroom.

Correa visited a clinic in Tijuana Mexico earlier this year, where American vets have sought psychedelic therapy. He stated that people will use MDMA to treat mental illness, no matter what FDA decides.

Luttrell says ibogaine, 5-MeO DMT and other drugs helped him recover from trauma when his Black Hawk helicopter crashed during a training exercise.

Luttrell stated that the bipartisan group of Congress is “doing its best” to “keep the focus very hot on our wish for this to be passed now.”

It’s a delicate balance. Luttrell had asked his colleagues in the Congressional Psychedelics Advancing Therapies Caucus if they wanted to meet Califf. But the legislators decided that such a direct approach was not good. The group is hoping that the FDA will overhear their parallel conversations.

Bergman explained that they didn’t want the FDA to be irritated by a direct poke in the face, as it would create aversion. They’d then keep their heads down.

Lykos’ application was still being reviewed, so the FDA declined to comment. The FDA pointed POLITICO at a draft guidance document it released on psychedelics trials last year to show its current thinking.

One ally doesn’t seem to be as diplomatic. Rep. Dan Crenshaw – who is also a Texas Republican, a former Navy SEAL and a Texas Republican – slammed the FDA advisers in a video, accusing them of being biased against servicemen and doing the bidding for pharma companies whose product would be affected if Lykos application was approved.

Musk shared the video with his 193 million Twitter followers, adding the comment: “Dan is right about this.”

In an interview Crenshaw said that psychedelics had saved the lives of some of his closest friends and that Lykos’ therapists were justified in expressing their passion for an effective treatment.

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