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We were in FDA's trial for MDMA - here's why it should NOT be approved to treat PTSD
Trials looking at the health benefits of MDMA ignored patients' worsening suicidal tendencies, according to multiple people involved in the studies.
Three volunteers with PTSD said they felt more depressed weeks into the trial and for weeks after it ended, an effect of taking the psychoactive drug, also known as ‘molly’.
Lykos Therapeutics, the company masterminding the push to legalize MDMA for post-traumatic stress disorder, is accused of bias in reporting trial results to show a positive effect on people's PTSD symptoms, pressuring people to report positive effects, and ignoring those who said their symptoms got worse.
The ongoing trials have been plagued with allegations of sexual misconduct and of doctors overseeing the study of holding ‘underground’ MDMA sessions not sanctioned by the trial using the drugs illegally.
Patients take a dose of the drug while under supervision. Sessions with a therapist then help people to come to terms with their trauma
MDMA raises levels of three feel-good neurotransmitters in the brain - serotonin, dopamine, and norepinephrine. When a person 'comes down' from the high from the drug, those neurotransmitter levels plummet, leaving a person depressed and anxious
Accounts of people's negative experiences on the drug in a therapeutic setting comes amid FDA deliberation about whether to approve a version of the drug to treat PTSD.
The agency's panel of independent drug reviewers voted overwhelmingly in June against approving it,alleging that Lykos Therapeutics, the company behind this particular formulation, suppressed data researchers didn't want to highlight as well as study misconduct, including sexual assault.
They also noticed that blinding was difficult, given that people who took the drug as well as the therapists overseeing their experience could tell they were on it, while placebo recipients could tell they were not.
Despite the panel's recommendation against it's approval, the FDA doesn't necessarily have to tow that same line, and will make a decision before August 11.
The decision will indicate whether the stories of trial participants and their mental health woes are compelling enough to merit concern.
One of the subjects, Sarah McNamee of Montreal, told the Wall Street Journal that she felt pressure to report positive outcomes.
She said: ‘I wanted the miracle cure. My therapists made it really clear that they really really believed in this thing.
‘It made me feel like I belonged to something bigger than me, and it also made me feel like I had a serious responsibility to make sure that other people could get access.’
The therapy had made her feel as though she had been ‘cracked open.’ The trial’s design meant focusing on one traumatic event in her life to be made better, but she has been stricken by several traumatic events.
While she fared better dealing with one of those events, the drug trial brought out painful memories from others.
In written public comment to the FDA, Ms McNamee said that she went along with certain suspect things that trial therapists did, because she trusted that they would conduct research that passed scientific muster.
They also implied that her participation in the trial, specifically if she responded well to it, would bring about a 'paradigm shifting treatment'.
She said that therapists encouraged her to view her worsening PTSD symptoms 'as evidence of healing and “spiritual awakening;” seeding mistrust in mainstream psychiatry; talking to me about past life traumas; encouraging and, one time, pressuring me to cuddle with them.'
She added that when she tried to tell therapists in the trial that she seemed to be fairing very poorly, one of them said that she would be 'feeling better in six months time.'
‘When I tried to tell my therapists about my emerging and worsening mental health symptoms at the end of the trial, one of them responded that he predicted that I would be feeling better in six months time.'
Two other study subjects said they had more frequent suicidal thoughts after trial stopped. At that point, researchers were no longer taking patient information and therefore did not take into account that those patients were having an extremely negative reaction to the drug.
One subject declined to join a longer-term trial because of the severe blow the drug had taken on her mental health, while the other who did participate in the longer trial said she didn’t report that she had become more suicidal after the initial trial had ended.
They cited bias within the trial’s design, noting that all of the doctors overseeing the treatments were fervent believers in the drug’s ability to change lives and convinced participants of that too.
People familiar with the trials also said the investigators offered people MDMA for underground, non-sanctioned sessions even while they were involved in the clinical trials.
Lykos, though, admits their investigators pass serious muster to be involved in the trials.
At the same time, the company had to acknowledge that some of its therapists had committed malpractice after a study subject reported that both her male and female therapists held her closely while lying together on a bed.
Dr David Rind, chief medical officer for the Institute for Clinical and Economic Review, a nonprofit that reviews drugs and their prices, said: ‘You want to make sure that the therapists are very, very clear that they should not be implying to people that it’s globally important what the results of the trial are and encouraging people to have favorable outcomes.’
Ms McNamee was at first a staunch believer in the power of psychedelics for people like her and those with major depression.
But she told NPR: ‘Three months after I was given my first dose of MDMA, I was for a time one of the staunchest advocates for 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 proponents of MDMA is three-star retired Marine Corps helicopter pilot Jack Bergman, who is running for his fourth term as representative of a northern Michigan district in Congress.
A Republican, he is now pushing hard alongside fellow vets and members of Congress to push for FDA approval.
He is joined by the likes of fellow lawmakers, both Republican and Democrat, as well as tech titan Elon Musk.
Bergman said: ‘Every day that goes by that research isn’t being done, that’s more lives being lost, primarily to suicide. A lot of those veterans are on a dark path,’ and mimed putting a gun to his head.
‘The strategy here is to put pressure in a positive way so that the bureaucracy feels it’s OK to assume some risk.’
In addition to voting nine-two on whether Lykos’ evidence was strong enough to support the treatment’s efficacy, the committee voted 10-1 to say that the drug's downsides outweighed its benefits.
Some of the risks they cited included potential effects on heart health, its potential for abuse, and the fact that Lykos appeared to have omitted important safety results, with one saying, 'There are significant holes in the data.'
MDMA provides an immediate enjoyable feeling by stimulating the release of neurotransmitters, such as dopamine, norepinephrine, and serotonin, in the brain.
It’s a combination of psychedelic and stimulant and often causes a burst in energy as well as hallucinations.
Like many addictive drugs, MDMA causes a sense of euphoria, but is most often associated with its social effects, causing someone to feel friendlier and closer to other people, and more loving. It’s most common at music festivals and raves.
Research from 2014 shows that MDMA reduced people’s ability to detect anger in others’ faces but didn’t affect their ability to identify happy faces, suggesting that the drug’s ‘prosocial behavioral effects might be partially explained by a decreased capacity to perceive negative emotional states in others.’
But it’s not without its major downsides, which include suicidal ideations and tendencies.
Taking drugs alters a person’s brain chemistry. It can lead to anxiety, greater depression, and panic attacks, as well as nausea, diarrhea, headaches, and insomnia.
It’s believed to be due to the rush of feel-good neurochemicals flooding the brain during the high, followed by lower-than-average levels of those chemicals in the hours and days after the drug leaves one’s system.
This feeling may also encourage someone to take the drug again and to keep taking it to mitigate those effects. In 2022, it was estimated that around 2.1 million people in the United States had used ecstasy, also known as MDMA or Molly, in the past year.