A panel of top scientists has warned theFDAagainst approving MDMA for post-traumatic stress disorder (PTSD), despite widespread calls from campaigners to offer the party drug to sick patients.
The landmark conclusion comes as a huge blow to the emerging field of psychedelic medicine and the millions of dollars that investors have poured in.
The group of experts — thePsychopharmacologic Drugs Advisory Committee —convened to help the agency decide whether to allow doctors to prescribe the drug, ahead of the official ruling on August 11.
In a damning conclusion, the panel stated that more research is needed to cement the psychedelic's therapeutic benefit.
The meeting is the farthest that a drug based on MDMA, commonly known as ecstasy or molly, has ever reached in the FDA regulatory process for approval.
Patients take a dose of the drug while under supervision. Sessions with a therapist then help people to come to terms with their trauma
Clinical trial participants were given 120 mg or 180 mg of MDMA — the standard amount for one or two pills
However, The FDA could still reject the panel's recommendations and decide to approve the drug anyway.
If doctors and therapists would be able to prescribe the illegal substance, also known as ecstasy, to patients suffering from the condition which triggers repeated, life-ruining flashbacks.
It follows the approval of the horse tranquilizer ketamine for treatment-resistant depression in 2019, despite some doctors' concerns about the risks.
While physicians have long used ketamine as an anesthetic, MDMA has never before been used in medicine.
It follows a recent clinical trial involving 200 patients that showed that MDMA improved symptoms in 86 percent of PTSD sufferers.
If approved, the drug will be offered as part of MDMA-assisted therapy, which involves peppering doses between sessions of talk therapy by a licensed mental health provider.
This would be the first new treatment for PTSD in over two decades.
Experts have welcomed the committee's analysis, and predict that the health authority will choose to approve MDMA.
Dr Joshua Gordon, director of the National Institute of Mental Health described the official meeting as 'exciting'.
'The promise is there, the potential is there, and we just have to find out through careful study and time how impactful these medications will be,' he toldCNN.
Meanwhile, Dr David Olson, director of the UC Davis Institute for Psychedelics and Neurotherapeutics, claimed studies have shown that those who enroll in the treatment 'get better'.
And last week the FDA published a briefing document on the potential approval, stating that patients in studies have, 'experienced statistically significant and clinically meaningful improvement in their PTSD symptoms,' which appeared, 'durable for at least several months'.
MDMA is a stimulant and psychedelic that is thought to rewire connections in the brain, dampening the part that controls fear, allowing patients to open up with a therapist and face their trauma head on without being overcome with anxiety.
It has been an illegal substance since 1985 when the Drug Enforcement Administration categorized it as a Schedule 1 drug — the agency deemed it to have no medical use and a high potential for abuse.
It is thought that prior to that, hundreds of therapists offered the drug to patients in North America and Europe to address trauma.
Lykos Therapeutics, formerly known as the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC), a company that is developing prescription psychedelics, conducted the trials and has been advocating the legalization of MDMA-assisted therapy since 1986.
The CAPS-5 total score on the y axis shows the average severity of patients' PTSD symptoms
In 2017, the FDA assigned 'breakthrough therapy' status to MDMA-assisted therapy as a PTSD treatment, which meant its development could be expedited.
The agency has awarded the same categorization to four more psychedelic compounds, including psilocybin 'magic mushrooms' for depression and a substance similar to LSD for anxiety.
The most recent MDMA trial, by experts at the University of California, found that more than 86 percent of participants who received the drug had a measurable reduction in the intensity of their symptoms, and 71 percent entered remission.
Meanwhile in the placebo group, 69 percent improved and almost 48 percent no longer reached the threshold for a PTSD diagnosis.
But there has been widespread criticism of many of the the studies relied on to prove MDMA's efficacy.
In its recent publication, the FDA said the studies were heavily biased because participants and therapists could easily work out who received MDMA versus the placebo.
It also pointed to cases of liver toxicity and 'significant increases in both blood pressure and pulse' which have the potential to trigger cardiovascular events such as a heart attack or stroke.
As well as claims of bias in the research, a report by the Institute for Clinical and Economic Review (ICER), a nonprofit that evaluates clinical trials, described the most recent results as 'inconclusive.'
The ICER report was followed in April by a citizen petition which alleged misconduct and ethical violations during the research.
Lykos Therapeutics sponsored the trial, but researchers involved in the study have fiercely rejected the accusations that because the drugmaker paid for trial, the results are inherently biased.
'I didn't feel any pressure from the sponsor to come up with anything different than what the data was providing. I wouldn't have continued to work with them if I had felt that,' said Jennifer Mitchell, the lead researcher on the Phase III trial.
The ICER report also suggested thatsome of the therapists, investigators and patients had 'very strong prior beliefs', including pro-drug views, that could have affected the results.
'Concerns have been raised by some that therapists encouraged favorable reports by patients and discouraged negative reports by patients including discouraging reports of substantial harms, potentially biasing the recording of benefits and harms,' the document said.
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More than 70 clinicians, investigators and other individuals involved in the Phase III trial published a thorough response to the doubts in the ICER report, saying the criticisms are based on 'hearsay.'
A particularly damming aspect of the trial occurred in Phase II. A podcast, made by New York Magazine and the nonprofit organization Psymposia, detailed claims by a trial participant Meaghan Buisson.
She was paired with a married couple, Dr Donna Dyer, who is a licensed therapist, and her husband Richard Yensen, who is an unregulated psychotherapist.
Videos showed Yensen asking Ms Buisson to spread her legs, and Dr Dyer and Yensen lying on top of her, as well as stroking her face and climbing into bed with her.
Ms Buisson was marked as a success story in the trial by the researchers.
After the study, Ms Buisson moved to a small island where Dr Dyer and Yensen lived, where she carried on doing therapy with them.
Yensen said he started what he called a consensual 'intimate and sexual relationship' with Ms Buisson, who later reported him to the police for sexual assault and therapy abuse.
Lykos Therapeutics, called MAPS at the time, found that the married therapists 'substantially deviated' from protocol and barred them from being able to provide MDMA-assisted therapy.
PTSD affects 13 million Americans and is especially common among war veterans who are at high risk of suicide.
It involves symptoms such as flashbacks, nightmares, severe anxiety, overwhelming guilt or shame and angry outbursts or aggressive behavior.
There remains a large unmet need for new treatments for PTSD as existing drugs do not work on all patients.
