Health

FDA adviser rejects MDMA as clinical treatment for PTSD

Federal health advisers have rejected the first-ever proposal to use MDMA to treat PTSD, a non-binding vote that poses a potential roadblock for psychedelic advocates who want to make banned drugs mainstream.

Advisers to the Food and Drug Administration said the study data was flawed, the way the studies were conducted was questionable and there were serious drug risks, including heart problems, injury and potential for abuse.

But strong supporters of MDMA therapy continue to praise its effectiveness, including advocate Lori Tipton, who took part in clinical trials for the drug.

The New Orleans resident was diagnosed with post-traumatic stress disorder by doctors after Hurricane Katrina devastated her hometown.

“My brother died of a drug overdose, then my mother murdered two women and then committed suicide. I was the one who found their bodies in the house,” Tipton said. “I began to have severe mood swings, panic attacks and insomnia. I also had intrusive thoughts and suicidal thoughts.”

After trying various treatments to no avail, in 2018 she enrolled in a clinical trial testing the hallucinogen MDMA, also known as ecstasy or Molly.

After three supervised sessions, where Tipton was given microdoses and then underwent patient-led talk therapy, she says reconnecting with buried memories has paved the way for her to heal.

“It helped me see things in a totally different light and understand the amount of shame and fear I was carrying,” Tipton said.

At present, the committee does not recommend that MDMA be incorporated into mainstream medical care, feeling that the risks do not outweigh the benefits.

“The only way to legally get this treatment in this country right now is to go through a clinical trial,” said Dr. April Soto, founder of Lalim Health.

Dr Soto says mind-altering drugs can help patients come to terms with the trauma.

Lykos Therapeutics, the company behind the study, announced results from two late-stage studies.

“67 percent of patients who received MDMA no longer met criteria for PTSD,” Dr. Soto said, compared with 32 percent of those who received a placebo.

She stresses that there are known safety risks, including hypertension, elevated blood pressure and tachycardia, so a thorough medical evaluation is required.

Six years on, Tipton has no need for MDMA therapy and continues to advocate for it.

“It saves an incredible number of lives, at least in my experience,” Tipton said.

MDMA is the first in a series of psychedelic drugs, including LSD and psilocybin, that are expected to come under FDA review within the next few years amid renewed interest in the drug's medical potential as it could revolutionize the treatment of mental illness.

The FDA typically follows the committee's recommendations but is not required to do so. A final decision is due on Aug. 11.

The Associated Press contributed to this report.

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