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Why the most powerful celeb book clubs love The Tell
Why the most powerful celeb book clubs love The Tell

CBC

time25-03-2025

  • Entertainment
  • CBC

Why the most powerful celeb book clubs love The Tell

A new memoir has made book club history. The top three book club owners — Oprah Winfrey, Reese Witherspoon and Jenna Bush Hager — came together to celebrate the launch of Amy Griffin's new memoir, The Tell. The book shares the businesswoman's path to healing after MDMA-assisted therapy unearthed a long-hidden childhood trauma. Today on Commotion, host Elamin Abdelmahmoud speaks with The Cut's Emily Gould about her thoughts on the memoir, as well as what it means to have it lauded by the giants of the book club world. Interview with Emilly Gould produced by Jane van Koeverden.

DOD commits $9.8 million to study psychedelics for active-duty troops
DOD commits $9.8 million to study psychedelics for active-duty troops

Yahoo

time17-03-2025

  • Health
  • Yahoo

DOD commits $9.8 million to study psychedelics for active-duty troops

Physicians at Walter Reed National Military Medical Center confirmed they will receive one of two $4.9 million grants from the Department of Defense to fund a study of MDMA, the active ingredient in the street drug known as ecstasy, according to emails shared with Military Times. The psychedelic drug will be given to active-duty Army personnel with mild to moderate post-traumatic stress disorder to study the psychological flexibility patients experience as a potential mechanism of MDMA's therapeutic effect. The second grant will fund a separate MDMA-assisted therapy study done in partnership between Emory University and STRONG STAR, a medical consortium and training network based in the University of Texas Health Science Center at San Antonio. While the U.S. government first conducted illegal experiments with psychedelics on soldiers half a century ago, this new study marks the first-ever trial of MDMA for the treatment of PTSD in active-duty soldiers. Maj. Aaron Wolfgang, a U.S. Army psychiatrist who specializes in treating PTSD, will be the lead author and physician of the double-blind placebo trial. Wolfgang is the first author in a systematic review and overview of MDMA and MDMA-assisted therapy featured in the January issue of the American Journal of Psychiatry. The article, written by a cohort of leading psychedelic researchers, describes common misconceptions about MDMA due to its close association with classical psychedelics like LSD, psilocybin and mescaline. 'Unlike other psychedelics,' the paper says, 'MDMA uniquely induces prosocial subjective effects of heightened trust and self-compassion while maintaining ego functioning as well as cognitive and perceptual lucidity.' VA awards $1.5 million to study using psychedelics for PTSD treatment This apparent gain of function suggests what advocates for the legalization of MDMA have been saying for decades: the drug is uniquely positioned to be a breakthrough therapeutic for treating many psychological disorders. The new study would enroll active-duty service members, who would each receive three MDMA dosing sessions between three and five weeks apart over the course of 10 months. Participants would receive three preparatory sessions before the first dosing session and three integration sessions after each dosing session. 'Unlike other MDMA-Assisted Therapy/Psychedelic Assisted Therapy long-term studies, this will be one of the first that I'm aware of to incorporate long-term follow-up that remains double-blinded, which will provide us with higher confidence data,' Wolfgang said. The pharmaceutical company Lykos Therapeutics, formerly MAPS PBC, made a major push in December 2023 for MDMA to receive FDA approval. When approval was denied in August 2024, the result came as a shock to advocates for psychedelic-assisted therapy, many of whom were veterans and their family members. FDA rejects psychedelic MDMA as treatment for PTSD 'I think that PTSD should be treated while you're in service, not force you to decide to stay in or get out in order to receive the care you need,' said Jonathan Lubecky, an Iraq War veteran who served with the Marine Corps' Bravo Battery, 5th Battalion, 113th Field Artillery Regiment. Last June, Lubecky provided testimony at an FDA public hearing, where he credited MDMA-assisted therapy, which he underwent in 2014, with allowing him to 'truly live' for the last decade and weather many of life's traumatic experiences long after returning from his deployment. Wolfgang believes the military will have more success in elevating the legitimacy of MDMA-assisted therapy. The history of MDMA and the military runs deep. An animal toxicology study of MDMA was done by the US Army Chemical Corps in 1953 and 1954 as part of the secretive Edgewood Arsenal experiments. Vets used in secret tests make progress in court About 20 years later, American biochemist Alexander Shulgin taught retired Army Lt. Col. Leo Zeff, a psychiatrist and psychotherapist, how to use MDMA to treat his therapy patients. Zeff was so taken by the drug that he came out of retirement to proselytize MDMA's therapeutic benefits and train more than 100 therapists. Shulgin, a Navy veteran who served on the Clemson-class destroyer Pope during World War II, went on to synthesize several unique psychedelics, including 2-CB, often described as a combination of MDMA and LSD. Wolfgang hopes a new generation of soldiers could benefit from the drug's consideration as a breakthrough therapy. 'I also envision this project — and the lasting program I hope to see it turn into — as a beacon of hope for countless service members and their families who are suffering and whose lives are being upended due to PTSD,' Wolfgang said. '[They] already sacrifice so much in service to our country. I'd like for them to know that we hear them and to know that we are working tirelessly to ensure we offer them the absolute cutting edge.'

This NYT Story Blasting Leftists Is Wildly Misleading and Dangerous. Why Did They Publish It?
This NYT Story Blasting Leftists Is Wildly Misleading and Dangerous. Why Did They Publish It?

Yahoo

time07-03-2025

  • Health
  • Yahoo

This NYT Story Blasting Leftists Is Wildly Misleading and Dangerous. Why Did They Publish It?

Sign up for the Slatest to get the most insightful analysis, criticism, and advice out there, delivered to your inbox daily. On Feb. 4—the same day that Robert F. Kennedy Jr.'s nomination for secretary of Health and Human Services advanced out of the Senate finance committee—the New York Times published a story with the headline 'How a Leftist Activist Group Helped Torpedo a Psychedelic Therapy.' The story claims that Psymposia, a psychedelic-science and harm-reduction nonprofit consisting of five unpaid volunteers, used baseless and misleading accusations to thwart Food and Drug Administration approval of MDMA-assisted therapy, or MDMA-AT. Without the efforts of this 'small band of anticapitalist activists,' the authors argue, Lykos Therapeutics' '$250 million investment' in MDMA-AT may have paid off by being the first psychedelic therapy to get federal approval—potentially establishing the company as a multibillion-dollar enterprise. As a journalist who has followed the psychedelics movement for years and attended hearings during the FDA approval process to write about them for Slate, the story was stunning. It was largely divorced from the events as I witnessed them, misleading in crucial ways, and journalistically bewildering. But what the story lacks in fully recounting why Lykos' application tanked, it makes up for in fostering outrage, scapegoating a fringe group, and establishing a useful narrative should the new HHS secretary want to reverse the FDA's decision. The core argument about Psymposia outlined in the New York Times article—that individuals from the organization deliberately raised baseless, inflammatory allegations in a vendetta against Lykos and veterans—isn't new. It's an allegation initially posited by the Heroic Hearts Project, an organization that advocates for veterans' access to psychedelic therapy. RFK Jr. retweeted that statement, and proponents of Lykos' therapy later echoed the narrative in a video posted on the social media accounts of Lykos' parent company, MAPS—the Multidisciplinary Association for Psychedelic Studies. To understand how we got here, though, it's worth stepping back. The first domino fell in March 2024 when the Institute for Clinical and Economic Review—an independent group that evaluates the value of new medical treatments—published a draft review of the Lykos trials. The authors of the report said they had 'substantial concerns about the validity of the results,' noting poor experimental design choices and potential misconduct. The FDA's Psychopharmacologic Advisory Committee—which reviews drug applications for safety and efficacy, voting on whether they should recommend approval to the FDA—met on June 4 and lamented that Lykos failed to collect important patient safety information, like liver and heart function; declined to record elevated mood and euphoria as they'd explicitly been instructed to do; and neglected to use a placebo per department recommendation. The list goes on and has expanded considerably with further reporting in the wake of the FDA's decision. The NYT story glosses over these data collection missteps, failing to mention mishaps like Lykos' failure to take study participants' lab work or EKG data. The article and advocates for Lykos are quick to note that the FDA approved the study design. But Michael Ostacher, a professor of psychiatry behavioral sciences at Stanford University who has worked on esketamine studies, told me that's misleading. 'Just because the FDA accepts a trial design doesn't mean they approve the application if the trial gets positive results,' he said. 'Plus, Lykos ignored things the FDA had asked them to do.' The NYT story also begins with a strange and misleading characterization of Psymposia's role at the public comment period of the advisory committee meeting, claiming that seven members connected to Psymposia 'presented themselves as experts in the field of psychedelics, but none had expertise in medicine or therapy.' It goes on to assert that none of these speakers disclosed their connection to Psymposia, 'a leftist advocacy group' with a vendetta against MAPS. Only three of Psymposia's five members spoke during the public comment period, and none presented themselves as having expertise in medicine or therapy or suggested that expertise in psychedelics translated to expertise in medicine or therapy. First to speak was Neşe Devenot, who the story refers to as a 'self-described expert in psychedelic bioethics who uses gender neutral pronouns.' Indeed, Devenot introduced themself as an expert in 'psychedelic bioethics,' but their credentials aren't merely 'self-described.' Devenot completed a postdoctoral fellowship in the department of Bioethics at the Case Western Reserve University School of Medicine and is an affiliate researcher with the Project on Psychedelics Law and Regulation at Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. The other speakers included Brian Pace, who introduced himself as a lecturer teaching psychedelic studies in the Department of Plant Pathology at Ohio State University, and Russell Hausfeld, who stated that he was there in his capacity as a journalist who reports on psychedelics and never claimed expertise in the psychedelic field. While it's true that none of the members of Psymposia disclosed their affiliation to the organization during the public comment portion of the hearing, they didn't have to. The FDA guidelines given to all speakers during the public comment period were 'to advise the committee of any financial relationship that you may have with the applicant,' which Devenot, Hausfeld, and Pace do not have. The day before the hearing, the three speakers published a press release stating their affiliation with Psymposia, and Hausfeld had previously disclosed his affiliation with Psymposia in a May 30 email to the advisory committee, clarifying that he would be speaking on behalf of himself, not the organization. When the advisory committee declined to recommend acceptance of Lykos' application, the Heroic Hearts Project veterans group published a statement claiming 'ICER relied on' Devenot and Psymposia while drafting the report. However, Devenot told me that neither they—nor, to their knowledge, anyone from Psymposia—was even aware that ICER was working on a draft report before its publication. In a transcript I reviewed of an interview between the reporters and three Psymposia members, Devenot said, 'We found out about the draft the same time the rest of the field found out about it.' The published story seems to suggest otherwise, arguing that 'Psymposia ramped up efforts to thwart Lykos's application,' adding that the group eventually 'found an audience' with ICER, resulting in the report echoing many of Psymposia's ethical concerns. Perhaps one of the most egregious parts of the story, though, occurs when describing a documented case of a MAPS facilitator sexually assaulting a patient during and after the Phase 2 trials. The NYT authors write of 'an ethical violation that occurred in an early Lykos trial that was not part of the company's F.D.A. application, when a husband-wife therapy team in Canada spooned and cuddled a participant, Meaghan Buisson, during her MDMA session.' The story neglects to mention that Buisson, who was there in part to address sexual trauma she'd previously experienced, immediately started crying and curled into a ball when the male facilitator, Richard Yensen, asked her if she wanted to 'lie down and spread her arms and legs.' When Yensen tries to put a hand on her shoulder, she shakes it off. Later in the video, she's sobbing and saying 'Stop' as Yensen lays on top of her, restraining her movement. The article continues to minimize the sexual assault by pointing out that Yensen 'began a sexual relationship' with Buisson 'after the trial concluded.' Several crucial facts are left out of this description. Most obviously: Legally, and ethically, a patient cannot consent to a sexual relationship with their therapist, which MAPS notes in a statement it made about the incident in 2019. (Yensen's defense in the civil suit Buisson brought against him? He was an unlicensed therapist and thus had no 'duty of care' to her.) Additionally, the trial was not over when the sexual abuse began. I contacted the journalists who wrote the NYT story with detailed questions about these exclusions. A spokesperson for the publication responded with the following statement: 'This piece of independent journalism was thoroughly reported and fact-checked, and The Times stands behind its publication.' RFK Jr. has a long history of ignoring the minutiae and nuances of clinical data in favor of a zealous belief in unproven remedies with dramatic anecdotal evidence. The NYT story hints at this connection. After mentioning the FDA's ongoing review of Lykos' data, the authors write, 'Some advocates hope that the Trump administration will take a friendlier approach,' specifically noting Elon Musk and RFK Jr. as 'vocal supporters of psychedelic medicine.' Kennedy made his position clear. In October, after Trump announced that he would nominate the anti-vaccine activist for the position, Kennedy tweeted, 'FDA's war on public health is about to end. This includes its aggressive suppression of psychedelics … and anything else that advances human health and can't be patented by Pharma.' Lykos is a pharmaceutical company and has filed several patents related to MDMA formulation. Investors know this even if the new HHS secretary doesn't—after Kennedy's nomination advanced out of committee on Feb. 4, shares in biotech companies making psychedelic therapies soared. Now a newly confirmed Health and Human Services secretary, Kennedy has the power to reverse what he calls the FDA's 'scandalous' decision or otherwise influence the ongoing FDA review of Lykos' Phase 3 data. When vague accusations of 'DEI' and 'wokeness' are already being used to gut government programs, it might not be a bad time to blame the FDA's decision on 'a small band of anticapitalist activists.' Michael Abrams, a senior researcher in Public Citizen's Health Research Group, told me he thinks it's unlikely that Kennedy would completely reverse the decision, but it's possible that 'the next time it goes through review, we might see the standards lowered, and the process goes a bit smoother for the sponsor.' Kennedy is already implementing changes at HHS that limit public input. On Feb. 28, he placed a statement in the Federal Register rescinding the public comment period where members of the public can argue for or against proposed HHS plans. Although the mandate doesn't necessarily affect FDA decisions, it's a troubling sign for transparency from the agency that oversees the FDA and the Centers for Disease Control, among other federal health bodies. The public narrative about what happened with MDMA-AT is important, as more potential psychedelic therapies are certainly in the pipeline. Painting the final stages of the FDA approval process as unnecessary and easily corruptible—as the NYT article did—may serve a larger 'MAHA' agenda of eliminating or severely restricting vital oversight. Kennedy—perhaps best known for his anti-vaccine advocacy—has spent decades suggesting that the decisions of federal oversight committees and medical associations can't be trusted due to conflicts of interest and corruption, an assertion some advocates for MDMA-AT also made after the FDA's decision. The NYT story seems to underscore this narrative by claiming Psymposia 'derail[ed] the approval of MDMA-assisted therapy' by committees like ICER that would otherwise have supported the application. In lieu of rigorously conducted clinical trials, Kennedy often cherry-picks dramatic and heart-wrenching anecdotal evidence to support his claims. For example, last year, he reposted an image of school shooters with the antidepressants they were allegedly taking. There is no evidence to suggest that SSRI drugs are a cause of school shootings. There is plenty of anecdotal evidence to support the efficacy of MDMA-AT on post-traumatic stress disorder. It has undeniably helped people who were struggling, many of whom are veterans and spoke at the FDA advisory committee. The unmet need for PTSD treatment has made psychedelic-assisted therapy a more bipartisan subject than it might be otherwise. (In 2024, Kennedy said that veterans are 'the most deserving of benefiting from psychedelic therapy.') The NYT story highlights this angle as well. It quotes Jonathan Lubecky, a retired U.S. Army sergeant and a psychedelic medicine policy advocate, who notes that many of his friends have 'fallen into despair' since the FDA's decision and that ''Some, quite frankly, are trying to decide whether they should stick around long enough to see it happen.'' It's a heartbreaking quote. Given the reporters' emphasis on Psymposia's disclosures, however, it is curious that the story doesn't mention that Lubecky was employed by MAPS from 2018 to 2023. Public health experts largely disagree that Psymposia could have such a dramatic effect on the FDA approval process. 'It's absurd, absolutely silly to say that five or six people undermined the success of Lykos' application,' said Ostacher. 'I'm really concerned that the true believers are driving the narrative about [psychedelic-assisted therapy] in a way that will make it very difficult for people not to believe the results of flawed trials.' Abrams agreed, adding that the committee didn't need to be experts in psychedelics to understand the application before them. 'The committee is smart, they understand things like bias, they understand things like liver toxicity, and reporting adverse events,' he said. 'But that's more nuanced than the rather provocative 'Leftist anticapitalist activists torpedoed multimillion-dollar case for veterans and cops' narrative.' But if anyone likes a 'provocative' theory that contradicts the medical establishment and paints the FDA as easily corruptible, it's RFK Jr.—and he doesn't need help from the Gray Lady to do it.

New York Magazine partnered with anti-psychedelics activists on MDMA series
New York Magazine partnered with anti-psychedelics activists on MDMA series

Yahoo

time09-02-2025

  • Entertainment
  • Yahoo

New York Magazine partnered with anti-psychedelics activists on MDMA series

In 2022, New York Magazine produced a podcast about the dangers of MDMA-assisted treatment for people dealing with post-traumatic stress, along with two leaders of an activist group dedicated to stopping the practice from becoming legal in the US. Now, the group is coming under greater scrutiny for its at times aggressive tactics, putting a spotlight on why the activist duo had editorial control over a major publication's podcast. Last week, The New York Times published a story about how Psymposia successfully helped derail an effort last year to convince the Food and Drug Administration to approve MDMA-assisted treatment for people dealing with post-traumatic stress. The story noted that two of the former primary figures in the group, David Nickles and Lily Kay Ross, had long been engaged in efforts to stop psychedelic therapy, including by exaggerating its risks, and tamp down criticism of their own group and its tactics. In a since-deleted 2018 post, Nickles 'outlined strategies for damaging psychedelic companies and nonprofits through persistent, critical media coverage and sabotaging 'business operations in ways designed to raise the costs of operating.'' In 2022, New York produced Cover Story, a limited series podcast, whose first season was about the dark side of psychedelic-assisted therapy. The show quoted Ross heavily as a source. But in an unusual arrangement, it also made her and Nickels co-producers on the show. (Psymposia said on its website that the group itself was a co-producer.) In a statement, a Vox Media spokesperson told Semafor that although they were producers on the show, Ross and Nickles were two members of a larger production team that included others with editorial oversight. 'New York Magazine retained full editorial control of the podcast, which was rigorously reported and thoroughly fact-checked, and raised important questions about the psychedelic renaissance that warranted deeper exploration,' the spokesperson said. In a statement to Semafor, Ross and Nickles said the New York podcast clearly explains how they are situated, and the accompanying articles for New York show the depth of their research and investigations into the world of psychedelic therapy. 'The New York Times article contains numerous inaccuracies and misleading assertions which we are working to get the paper to correct,' they wrote, disputing some parts of the Times' timeline. The Times also separately singled out Vox for repeating an explosive accusation that one of the therapists who took part in clinical psychedelic therapy trials, Veronika Gold, had admitted in her book to pinning down a screaming patient. The paper reported that the incident was actually much more complicated than it has been presented in the media, including a 2024 Vox article. Following Semafor's inquiry, a Vox Media spokesperson said the story had been updated and corrected to reflect that the drug used in the session was ketamine, not MDMA, and updated to include more context from Gold's account of the therapy session at the center of the allegation. The Times has done significant reporting on psychedelic therapy recently, rolling out a long feature late last year about veterans seeking out treatment in Mexico. Robert F. Kennedy Jr., President Donald Trump's nominee to run the Food and Drug Administration, has expressed openness to expanding access to psychedelics if he's confirmed, a prospect that excites advocates.

America rejected MDMA, but Australia didn't. Here's why psychedelics have been embraced Down Under
America rejected MDMA, but Australia didn't. Here's why psychedelics have been embraced Down Under

Yahoo

time28-01-2025

  • Health
  • Yahoo

America rejected MDMA, but Australia didn't. Here's why psychedelics have been embraced Down Under

In Sydney, Australia, Rebecca Huntley had been seeking psychiatric care on-and-off for thirty years when she heard from an otherwise straight-edged friend about her experience going through MDMA-assisted therapy. At the time, MDMA, also known as the party drug ecstasy, had been outlawed in Australia since 1987, despite research suggesting the drug can treat mental illness. But Rebecca's friend connected her with an underground therapist providing this service to a select clientele. After a rigorous vetting process, their first session took place at Rebecca's house, a quiet place surrounded by trees. 'I felt like I needed something other than what I was doing,' she told Salon. 'I was grinding my gears in terms of my mental health; I was pretty angry all the time. So I thought I'd give it a go.' 'It's like you've jumped forward in light-speed to an accelerated point in your mental health journey,' Rebecca added. 'For me, particularly the first session released an enormous amount of pain and grief and sadness that I had been spending years trying to push to the periphery of my consciousness. And the next day, after the drug was pretty much out of my system, I woke up feeling like I'd woken up in a different kind of body, a calmer body, a body that was more grounded.' After that it was a six month process, including two more trips with MDMA and follow-up integration sessions to make sense of the experience. Rebecca wrote a book, 'Sassafras,' about her journey. 'It's up there with giving birth to my three children in terms of genuinely life-changing experiences,' she said. In 2023, Australia became the first country in the world to legalize both MDMA and psilocybin-assisted psychiatric therapy, strictly under very specific conditions: MDMA for post-traumatic stress disorder (PTSD), and psilocybin (the drug in 'magic' mushrooms) for treatment-resistant depression. In the United States, the psychedelic renaissance was led by the charismatic Rick Doblin and his Multidisciplinary Association for Psychedelic Studies (MAPS), whose groundbreaking clinical studies appeared to show astounding results in treating PTSD with MDMA. The drug can spur patients away from inhibition and anxiety, which can be useful for therapists trying to get someone to open up. Doblin believed psychedelics could change the world, and openly admitted that just like medical marijuana, psychedelic therapy was a backdoor to legalization. Over a decade ago, MAPS spun their pharmaceutical development arm into a subsidiary known as MAPS Public Benefit Corporation, later renaming it Lykos Therapeutics. But last year, the U.S. Food and Drug Administration (FDA) rejected MDMA as a prescription medication, taking issue with Lykos' scientific rigor, dashing the hopes of patients and psychonauts alike. 'I was quite frustrated at some of the questions that were being asked [at the FDA hearing] that indicated the folks asking the questions clearly didn't have a real understanding of MDMA,' Dr. Stephen Bright, a drugs expert at Edith Cowan University in Perth, Australia, told Salon. 'There were concerns that people might develop problems with other substances after being administered MDMA, and within the course I teach, we're teaching the students not to frame things within that disease model. So it's a bit frustrating to see a prestigious U.S. government department promoting that model.'As medicinal MDMA's future in America looks uncertain, are there any lessons to be learned from Australia? If America had Rick Doblin, then Australia has Peter Hunt and his wife, opera singer Tania de Jong, the power couple behind Mind Medicine Australia (MMA) — essentially MAPS Down Under. Hunt, a multimillionaire investment banker, was haunted by losing his father to suicide when he was thirteen. The pair were inspired to launch MMA after a shroom trip in Amsterdam. 'The experience was so powerful that we felt compelled to help support the legal development of psychedelic-assisted therapies in Australia and start a charity to ensure safe and equitable access to these transformational treatments,' Tania told Salon. Like the FDA, Australia's Therapeutic Goods Administration (TGA) refused to clear MDMA and psilocybin at first, turning down MMA's initial application in October 2022 on the grounds there wasn't enough evidence, potential health risks, and clandestine diversion of drugs to the black market. But just a few months later, in February, the TGA abruptly reversed course, moving MDMA from Schedule 9, for prohibited substances like heroin, to Schedule 8, a category for controlled medicines. To get this to happen, MMA mobilized an immense letter-writing campaign, flooding the TGA with over 3,000 submissions from individuals describing how the substances helped them or why they should be legal. These mainly consisted of personal, not professional, viewpoints, but apparently this was enough to sway the decision. Citing new research into psychedelic medicine, the TGA finally allowed MDMA and psilocybin in a therapeutic context. Prominent researchers like Prof. David Nutt, a renowned neuroscientist from Imperial College London, flew in to show his support. The decision was still controversial to some experts, who cautioned against rushing ahead since psychedelics aren't for everyone and some vulnerable patients might actually wind up worse after a trip. Meanwhile, skeptics accused the TGA of caving in to peer pressure ('C'mon TGA, be cool'). The TGA replied that the benefits outweighed the risks. Tania dismissed these criticisms as 'nonsense.' 'There is a lot of clinical trial evidence to support the safe and effective use of these therapies in clinical environments,' she said. 'We have an increasing mental health epidemic in Australia with an estimated 1 in 4 people suffering with mental illness. There have been no substantive innovations in mental health treatments for over 50 years. Whilst further research is important – we are financially supporting a number of innovative trials – the argument that we don't have enough data to support limited accessibility in highly supervised clinical environments is not valid given the amount of supportive evidence and the high levels of suffering.' So why has the TGA proven more flexible than the FDA? 'Our advocacy efforts focussed on a limited rescheduling of MDMA and psilocybin as unregistered medicines, whereas MAPS was pursuing registration of MDMA,' Tania explained. 'With registration in the U.S., MDMA is likely to be more widely accessible for PTSD and able to be used off label for other relevant mental illnesses where there is research support for this, whereas in Australia MDMA, as an unregistered medicine, is available only for PTSD patients and psychiatrists must apply for a permit to become an 'authorized prescriber.' By pursuing a limited rescheduling, we were able to support limited access for those most in need, while the evidence base continues to grow to support wider scale accessibility.' This model, according to Tania, is more restrictive than what was proposed in the States, but allowing each clinician to prescribe at their discretion. But only those blessed by an ethics committee may become authorized prescribers. 'Most psychiatrists don't have the sort of experience with research to be able to write a protocol that's going to be approved by an ethics committee, which is why it's really limited how many authorized prescribers there are in Australia,' Bright explained. As a result, rollout has been slow — with the first-ever non-research medical prescription for 180mg of MDMA only written by a Melbourne doctor in January last year — and it came with an expensive price tag. Clarion Clinics, Australia's first private psychedelic therapy centre that opened in February last year, charges an eye-popping 27,000 Australian dollars (approx. $16,500 USD) for a full nine-month course, well out-of-reach for most Aussies. Medical marijuana too is legal in Australia, but so prohibitively priced that 78% of patients still score from dealers. 'I worry that people who are unwell aren't going to be able to access it — and desperate people will do desperate things,' said Bright. 'My worry is that people will access these treatments either in an underground setting or try a DIY approach, and that could potentially result in harm. We've actually seen a significant increase in calls to the poisons hotline related to MDMA and other psychedelics.' Recreational molly is still illegal in Australia, manufactured or imported by crime syndicates like the 'Ndrangheta, mafia clans from southern Italy who made their riches in Australia's drug game by growing weed in the Outback. In 2016, Pasquale Barbaro, the scion of a mob family behind a plot to smuggle a whopping 15 million ecstasy pills weighing 4.4 tonnes hidden in tins of peeled tomatoes, was gunned down by a biker gang while leaving a friends' house in Sydney. And since the drugs are prohibited, there's no telling what's inside and they often mixed with other substances: recently, partygoers at festivals have been victims of nitazene poisoning, a synthetic opioid. 'I think the early evidence is that it can be, again, life changing, so I'm very excited,' said Rebecca. 'But I've got to say there's some trepidation about how it's going to go and who's going to have access to it. And of course, there's a massive underground … My therapist who I worked with is just top-notch; so good, so diligent, so professional … But there are people who aren't. There are people who aren't really doing the due diligence, aren't really working out whether the person that they're treating is ready for the therapy.' There are also efforts to bring down the cost. 'MMA has set up a patient support fund to help those in need who can't otherwise afford the treatment with up to 50% of upfront costs for the therapy program being covered by the Fund,' Tania said. 'Additionally, we're seeing funders begin to support the therapies. Work Cover and the NDIS have subsidised treatment for some patients, the Department of Veterans' Affairs has announced that they will begin assessing applications for funding by the end of March 2025, and multiple private health insurers are preparing pilot programs for their members.' Another company, Emyria, is offering free MDMA-assisted therapy trials to first responders grappling with PTSD. Another danger that could arise is a moral panic. The media certainly has the incentive to sensationalize drug use, followed by calls to ban this 'sick filth,' but prohibition certainly offers no solutions to the mental health crisis or actually stops drug use. In 2001, a supervised injection facility run by Australia's Uniting Church opened in King's Cross, Sydney — a district at the epicentre of the overdose crisis, claiming 10% of all deaths nationwide. This was a place where narcotic consumers could safely inject under the supervision of trained medical staff. Anyone overdosing can be instantly attended to. A few years later, a newspaper splashed images of dozens of syringes littering the street over its front page. It turned out that the used needles actually belonged to the owners of a diabetic cat named Trotsky, who'd momentarily left their rubbish unattended only for it to spill over and be photographed by reporters. 'I'm largely very positive, but of course as we know with these things, there's so much stigma around the drug and so much bullshit around mental health, that it could all unravel,' Rebecca reflected. 'I feel like the world is looking at us and saying, you know, how might Australia do it? And so I really don't want us to f**k it up!'

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