MDMA, a drug that has been known on dance floors around the world since the 1980s as ecstasy, received a blow this Tuesday on its way to being approved by the US Food and Drug Administration (FDA) for, combined with psychiatric therapy, treat patients suffering from post-traumatic stress disorder.
Forty years after its illegalization, defenders of the therapeutic uses of the substance cherished this return to the surface, which is perhaps irremediably receding after this Tuesday a panel of 11 outside experts convened by the FDA voted overwhelmingly against him. There were seven hours of a grueling session in which they listened to the arguments of Lykos Therapeutics, the pharmaceutical company seeking its approval, and a group of specialists who cast doubts on the methodology of the experiments and on the effects of its intake on blood pressure. and the heart rate of the patients.
The 11 committee members responded to two questions: Do the available data prove that MDMA, in addition to psychotherapy, can be effective in treating post-traumatic stress disorder (PTSD)? And: Do the benefits of the treatment presented outweigh the risks it may entail? The response to both was negative: in the first case, by nine votes to two; in the second, by 10 to one.
All the eyes of the apostles of the so-called psychedelic revival were on that meeting. An FDA approval – which is not yet completely ruled out, but is becoming more unlikely – would serve to confirm the revival of the use of psychotropic substances such as MDMA (3,4-methylenedioxymethamphetamine), psilocybin, for the treatment of mental illnesses. (active component of hallucinogenic mushrooms), ibogaine or LSD, a possibility that has created great scientific and media expectation. If approved for use, ecstasy would become the first medication to be added to the formulary to treat PTSD in almost 25 years. It is a psychiatric condition suffered by 5% of the American population (about 13 million people), after suffering a traumatic experience, for example, having been a victim of sexual abuse.
MAPS, the organization behind Lykos Therapeutics and which has been organizing clinical trials for a decade that have already completed their phase III, the last, has in its crusade an unusual ally in drug affairs: the Department of Veterans Affairs. The most widespread ailment among those returning from the front lines in the endless war the United States has waged in recent decades is PTSD, and MDMA, according to Lykos, has shown promising results in mitigating it.
About 200 patients have participated in the clinical trials, which included three sessions of eight hours each, separated by four weeks. The treatment was completed by a dozen appointments with two psychotherapists to prepare for those sessions and to process what was experienced during them. Half received MDMA and the other half received a placebo. 86% of the former noticed an improvement in their symptoms, compared to 71% of the latter.
Criticism of the studies
An FDA report made public last week warned about flaws in the approach of these trials, since most patients knew when they were receiving a placebo or not: unlike other medications, psychoactive substances do not leave too many doubts about whether one is under its effects or not. After years in which psychedelic science has enjoyed growing acceptance in American culture, those tailwinds seemed to be turning in recent months for MAPS and its founder, Rick Doblin; especially after a respected nonprofit institution called the Institute for Clinical and Economic Review (ICER is its acronym in English), will publish a study this year which concluded that there was “insufficient” evidence of the benefits of MDMA-based therapy. In a letter sent Monday, the American Psychiatric Association supported the ecstasy research, but asked that all necessary information continue to be collected, without rushing, before its approval. These opinions weighed this Tuesday in the experts’ vote.
The session left time for testimonies provided by citizens who asked to participate. Several veterans argued for approval; there were complaints that MAPS trials ignored minorities and accusations of “homophobia and misogyny” about the assisted therapy protocol; a psychiatrist asked for time and an oncologist shared a “positive case among many others” of a patient whose life had improved after taking ecstasy.
MDMA was synthesized for the first time in 1912, but science put it into oblivion until in the seventies an eccentric chemist named Alexander Shulgin, credited with being the author of some 320 psychoactive compounds, reformulated it to introduce it into psychiatric practice. by virtue of its properties to increase empathy and sociability. By the mid-eighties, the substance, a gentler psychedelic than others with greater power to alter consciousness, such as LSD, had already taken the dance floors and laid the foundation in Europe for cultural rave.
In the United States, the drug, which is also known as molly, was banned for the first time in 1985, when the Administration included it, along with heroin, in Group I of controlled substances, due to its “high potential for abuse.” Unlike opioids, the risk of getting hooked on MDMA is, by the narcotics agency’s own admission, “extremely low,” although during Tuesday’s session Maryann Amirshahi, one of the committee members and professor of emergency medicine at Georgetown , assured that he is seeing more cases of MDMA overdoses lately.
An FDA approval for therapeutic purposes could open the door to future legalization of its recreational use, but it would mean just that: a possibility. What it would allow is your medical prescription for alternative uses, under what is known in the United States as the off label (off label). This is what happens with medicines (for example, a diabetes drug like Ozempic) when they are used for a purpose other than their original purpose (losing weight). In the case of MDMA, it would not be unreasonable for doctors to prescribe it to treat anxiety or depression.
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