We Were At The FDA Trial Of MDMA — Here’s Why It Should NOT Be Approved To Treat PTSD

According to several people involved in the studies, studies into the health benefits of MDMA did not take into account patients’ increased suicidal tendencies.

Three volunteers with PTSD reported feeling increasingly depressed in the weeks following the start of the trial and in the weeks afterward, as a result of taking the psychoactive drug known as molly.

Lykos Therapeutics, the company behind the campaign to legalize MDMA as a treatment for post-traumatic stress disorder, has been accused of being biased in reporting research findings to show a positive effect on PTSD symptoms, pressuring people to report positive effects, and ignoring people who reported that their symptoms had gotten worse.

During the ongoing investigation, there have been allegations of sexual misconduct and of doctors overseeing the study conducting “underground” MDMA sessions that were not sanctioned by the study but involved illegal use of the drug.

Patients take a dose of the drug under supervision. Sessions with a therapist then help people process their trauma

MDMA increases the levels of three feel-good neurotransmitters in the brain: serotonin, dopamine, and norepinephrine. When a person comes down from the drug high, those neurotransmitter levels drop, leaving a person depressed and anxious

Reports of negative experiences with the drug in a therapeutic setting come as the FDA considers whether to approve a version of the drug to treat PTSD.

The agency’s panel of independent drug reviewers voted overwhelmingly against approving the drug in June, alleging that Lykos Therapeutics, the company behind that particular formulation, had withheld data that researchers didn’t want to highlight and failed to investigate misconduct, including sexual abuse.

They also found that blinding was difficult, as both people taking the drug and the therapists monitoring their experience could tell they were taking the drug, while people given a placebo could tell they were not.

Despite the panel’s recommendation not to approve the drug, the FDA does not necessarily have to follow that line. It will make a decision by August 11.

The decision must show whether the stories of the study participants and their psychological problems are convincing enough to give cause for concern.

One of those surveyed, Sarah McNamee of Montreal, told the Wall Street Journal that she felt pressured to report positive results.

She said, “I wanted the miracle cure. My therapists made it very clear that they really, really believed in this thing.

“It made me feel like I was part of something bigger than myself. And it also made me feel like I had a serious responsibility to make sure other people had access, too.”

The therapy made her feel like she had been “broken open.” The goal of the study was to focus on one traumatic event in her life so that she would get better. However, she had experienced multiple traumatic events.

Although she coped better with one of those events, the drug trial brought back painful memories for others.

In a written public comment to the FDA, Ms. McNamee said she agreed with certain questionable actions by the research therapists because she trusted them to conduct research that met scientific standards.

They also indicated that her participation in the study, especially if she responded well, would represent a “paradigm shift in treatment.”

She said therapists encouraged her to view her worsening PTSD symptoms “as evidence of healing and ‘spiritual awakening’; they sowed distrust in mainstream psychiatry; they talked to me about past-life traumas; they encouraged me and, once, forced me to hug them.”

She added that when she told the therapists in the study that she was doing very poorly, one of them said she would “feel better in six months.”

“When I told my therapists at the end of the trial period about my increasing and worsening psychological symptoms, one of them replied that he predicted I would feel better in six months.”

Two other subjects said they had more suicidal thoughts after the study was stopped. At that point, researchers were no longer taking patient information and therefore did not take into account that those patients had an extremely negative reaction to the drug.

One subject did not want to participate in a longer study because the drug was such a big blow to her mental health. The other subject, who did participate in the longer study, said she did not report feeling suicidal after the first study.

They pointed out that there was bias in the design of the study. They noted that all the doctors who oversaw the treatments believed passionately that the drug could change lives and that they had convinced the participants of this.

People familiar with the trials also said the researchers offered people MDMA for secret, unauthorized sessions, even while they were involved in the clinical trials.

However, Lykos admits that its investigators have serious requirements for their involvement in the legal cases.

At the same time, the company was forced to acknowledge that some of its therapists had committed professional misconduct after a subject reported that both her male and female therapists held her down tightly while they lay on a bed together.

Dr. David Rind, medical director of the Institute for Clinical and Economic Review, a nonprofit organization that reviews drugs and their prices, said: “You have to make sure that clinicians are very, very clear that they should not tell people that the results of the study are globally important and that they should not encourage people to get positive outcomes.”

Ms. McNamee initially believed fervently in the power of psychedelics for people like her and those with severe depression.

But she told NPR: ‘Three months after I had my first dose of MDMA, I was for a time one of the most ardent proponents of MDMA therapy. The problem is that I was also suicidal and clinically decompensating in drastic and unprecedented ways.’

Advocates of MDMA for PTSD are pushing hard for its approval.

One of the most outspoken advocates of MDMA is Jack Bergman, a retired three-star Marine Corps helicopter pilot who is running for a fourth term as a representative of a northern Michigan district in Congress.

As a Republican, he is now working hard with fellow veterans and members of Congress to get FDA approval.

He is joined by fellow lawmakers, both Republicans and Democrats, and by tech giant Elon Musk.

Bergman said: “Every day that there is no investigation, more lives are lost, mostly to suicide. Many of those veterans are on a dark path,” he mimed as he held a gun to his head.

“The strategy here is to exert pressure in a positive way so that the bureaucracy finds it okay to take risks.”

The committee voted nine to two on whether Lykos’ evidence was strong enough to support the treatment’s effectiveness. In addition, the committee voted ten to one that the drug’s harms outweighed its benefits.

Some of the risks they cited included possible effects on heart health, the potential for abuse, and the fact that Lykos appeared to have omitted important safety results. One even said, “There are significant gaps in the data.”

MDMA provides an immediate feeling of well-being by stimulating the release of neurotransmitters in the brain, such as dopamine, norepinephrine and serotonin.

It is a combination of psychedelic and stimulant drugs and often causes an energy boost and hallucinations.

Like many addictive drugs, MDMA produces a sense of euphoria, but is most often associated with its social effects, making a person feel friendlier, closer to other people, and more loving. It is most common at music festivals and raves.

Research from 2014 shows that MDMA reduces people’s ability to detect anger in the faces of others, but not their ability to detect happy faces. This suggests that the “prosocial behavioral effects of the drug may be partly explained by a reduced ability to perceive negative emotional states in others.”

But it also comes with major downsides, including suicidal thoughts and tendencies.

Using drugs changes a person’s brain chemistry. It can lead to anxiety, greater depression and panic attacks, as well as nausea, diarrhea, headaches and insomnia.

This is thought to be because during the high, a flood of feel-good neurochemicals flood the brain, with levels of these chemicals remaining lower than average in the hours and days after the drug leaves your body.

This feeling can also encourage someone to take the drug again and continue taking it to mitigate those effects. In 2022, it was estimated that approximately 2.1 million people in the United States had used ecstasy, also known as MDMA or Molly, in the past year.