The first latest PTSD drug in over twenty years is up for approval. To achieve this, US authorities must do something they’ve never done before: give the green light to the mind-altering – and illegal – party drug called ecstasy.
The latest drug is a variant of MDMA (also often called ecstasy) and is manufactured by Lykos Therapeutics Inc., an unusual drug manufacturer founded by a nonprofit organization that has spent a long time working to make psychedelic therapies accessible to the masses.
On June 4, the general public will get its first indication of where regulators are leaning when outside experts from the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee discuss the info during a day-long meeting where each the corporate and FDA officials will present their arguments. A choice on whether to approve the drug is anticipated by August.
“Everything about this is unprecedented,” said Jonathan Alpert, chairman of the American Psychiatric Association’s research council.
Privately owned Lykos has proposed administering the pill along side 42 hours of talk therapy with two therapists, including three full-day sessions of MDMA.
“We are on the verge of integrating psychedelic medicine into conventional medicine,” said Lykos chairman Jeff George recently at a psychedelics conference in New York. Around 13 million Americans suffer from PTSD.
One influential government organization is upping the ante and is already preparing to supply the drug should it’s approved. The Department of Veterans Affairs, which runs the nation's largest health care system and has a disproportionate variety of PTSD patients, says psychedelics have “significant potential.” PTSD is a psychiatric disorder that happens after a traumatic event corresponding to combat deployment.
The FDA faces a dilemma. The controversy surrounding Lykos' study has escalated in recent weeks after a outstanding group that evaluates latest treatments raised “significant concerns about the validity of the results.” In a 44-page report published in March, the Institute for Clinical and Economic Review concluded that the evidence was “insufficient” to find out whether MDMA-assisted therapy was useful. At a public ICER meeting on Thursday, there was at times heated debate over whether the advantages of Lykos' treatment outweighed the risks. In a vote, ICER advisers decided almost unanimously that Lykos had not proven the treatment's advantages.
ICER was particularly concerned about whether the study could adequately prove the results of MDMA, since patients under treatment knew whether or not they had received the psychedelic drug. The gold standard in research is a so-called “double-blind study,” wherein neither patient nor doctor knows who’s receiving an experimental drug or a placebo with the intention to truly judge the difference. But that was not the one problem.
“If you wanted to design a study that contained all the fatal flaws, you couldn't do better than what was done for MDMA,” said Allen Frances, former head of Duke University's psychiatry department, who calls psychedelics the most recent in an extended line of overhyped psychiatry trends. The drug “is being rushed to the commercial market far too quickly.”
Need for brand new treatments
New treatments for PTSD are urgently needed. There are only two drugs approved to treat it, and current therapies don't work for many individuals. In recent years, MDMA and other psychedelic drugs like magic mushrooms have been touted as a cure-all for PTSD and a spread of disorders including depression, anxiety, nicotine addiction and anorexia. On paper not less than, the outcomes of MDMA's two Phase 3 trials are impressive: The treatment alleviated symptoms a lot that two-thirds of the people not met the factors for a PTSD diagnosis two months later. The drug received breakthrough designation from the FDA in 2017 and entered priority review this yr, meaning the agency plans to quickly review the drug for approval.
The results are “significantly better than what we have seen with the antidepressants currently approved by the FDA for PTSD,” said psychiatrist John Krystal of Yale University, who was not involved within the studies.
No one knows exactly how MDMA helps individuals with PTSD or other disorders. It can produce an increased sense of well-being and social openness while altering an individual's visual perception. Taking MDMA floods the brain with serotonin, a crucial mood-elevating chemical.
Some psychiatrists experimented with using it as a communication enhancer during therapy sessions before it was banned by the Drug Enforcement Administration in 1985. Scientific evidence suggests that the drug may promote therapy success by reducing the emotional response to traumatic memories and making it easier for people to discuss them.
But the very thing that makes the drug so effective also makes it difficult to evaluate its effectiveness. “If people know what they're getting,” Krystal says, “that can negate the value of a placebo.”
The ICER report also cited allegations that some negative patient experiences can have been underreported. It also said participants can have felt “pressured” to report good results and conceal bad ones. The report also confirmed an allegation of sexual misconduct during an early trial, including intimate contact between a patient and her therapists during a videotaped MDMA session, followed by alleged non-consensual sex with one in all the therapists in spite of everything sessions were accomplished.
The ICER report was followed by a separate petition to the FDA commissioner wherein greater than 70 independent researchers called for an extended public hearing to make clear quite a few issues related to the conduct of the studies.
Lykos said the FDA approved the design of the trials and that quite a few steps were taken to reduce bias. The trials “were very rigorous and very well designed,” said Amy Emerson, CEO of Lykos. The company said it had outside reviewers assess patients' symptoms to reduce any influence of unblinding. She said the corporate fastidiously trained all study sites on the best way to properly report unwanted effects. The company also said it investigated the abuse allegations and “developed policies and practices aimed at preventing, appropriately detecting and thoroughly responding to allegations of misconduct.”
The first of many hurdles
The nonprofit behind Lykos, the Multidisciplinary Association for Psychedelic Studies (MAPS), is funded by outstanding donors including hedge fund billionaire Steven Cohen and Republican political supporter Rebekah Mercer. In a method or one other, MAPS has been involved in nearly every major study of MDMA for PTSD. This has led to accusations that its tight-knit culture has created a quasi-religious atmosphere wherein negative reports in regards to the drug are frowned upon or downplayed.
In 2014, MAPS formed a nonprofit company to conduct clinical trials on MDMA. Earlier this yr, the corporate modified its name to Lykos and received $100 million in funding from outside investors led by Helena Special Investments. MAPS stays the biggest single shareholder. MAPS founder Rick Doblin, who’s a public figure in favor of the medicalization of MDMA therapy, is confident the info is reliable.
“We have done our best,” he said, to beat the bizarre challenges of researching psychedelic drugs.
At the ICER meeting on Thursday, Meaghan Buisson, the patient who experienced the alleged abuse, cautioned against rolling out the therapy on a broad scale. “There is no question that what happened to me will happen again to someone else. It's just a matter of time,” she said in the course of the public comment period of the meeting. “That doesn't negate the life experience of those who say they benefited from this trial, it just means they dodged a bullet.”
Jesse Gould, a former Army Ranger and founding father of the Heroic Hearts Project, a nonprofit that helps veterans with PTSD, testified that a brand new treatment is urgently needed. “If there is no MDMA, there is nothing in the pipeline,” he said. “Do the risks described in the MDMA report really outweigh the enormous potential benefits?”
ICER's external consultants agreed that latest treatments were urgently needed. But a red flag for Lykos was that the consultants almost unanimously judged that the corporate had didn’t prove that the treatment was helpful overall. None of the consultants agreed that the treatment was demonstrably higher than traditional talk therapy.
Even if Lykos' MDMA gets the green light from regulators, that might be just the primary of many hurdles. The DEA must classify MDMA right into a less restrictive category of controlled substances. Administering it requires special training for therapists. And the numerous hours of prescribed therapy could cost greater than $12,000 per patient, in line with ICER, which can make insurers hesitant to cover the prices.
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(With assistance from Jessica Nix.)
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