
近三分之一依靠政府提供医疗服务的退伍军人可能从服用致幻蘑菇或MDMA等致幻药物中获益。
Nearly one in three veterans who relies on the government for health care could benefit from taking psychedelic drugs like magic mushrooms or MDMA.
这不是某个嬉皮士或过气的1960年代摇滚明星的评估。这一说法来自安德鲁·格拉迪森,他是唐纳德·特朗普总统领导的退伍军人健康管理局的高级顾问。格拉迪森本月在一个致幻药物爱好者的会议上说,他渴望扩大退伍军人事务部的能力,以便向多达210万患有创伤后应激障碍或抑郁症等精神疾病的退伍军人提供这些药物。格拉迪森说,有640万退伍军人定期依赖退伍军人事务部获得医疗服务。
That’s not the assessment of some hippie or fading 1960s rock star. It came from Andrew Gradison, a senior adviser at President Donald Trump’s Veterans Health Administration. Gradison told a conference for psychedelics enthusiasts this month that he is eager to ramp up the VA’s capacity to give the drugs to as many as 2.1 million veterans with mental illnesses like post-traumatic stress disorder or depression. Gradison said 6.4 million veterans regularly rely on the VA for care.
没有任何政府监管机构认定致幻药物对精神疾病安全或有效。在前总统乔·拜登任内,美国食品药品监督管理局于2024年断然否决了一项提案,该提案拟批准将MDMA——又称摇头丸——与谈话疗法结合,用于治疗创伤后应激障碍患者。
No government regulator has deemed psychedelics safe or effective for mental illness. Under former President Joe Biden, the Food and Drug Administration in 2024 resoundingly rejected a proposal to authorize MDMA — also known as ecstasy — combined with talk therapy, to treat people with PTSD.
但在特朗普政府时期,致幻药物获得了第二次机会。特朗普于4月发布行政命令,要求加快相关研究、临床试验以及患者获取这些药物的进程。国会中的共和党人是致幻药物最大的支持者之一。而他们试图取悦的选民群体——退伍军人——中共和党人占比格外高。
But psychedelics are getting a second chance in the Trump administration. Trump in April issued an executive order to accelerate research, clinical trials and patient access to the drugs. Republicans in Congress are among psychedelics’ biggest backers. And the constituency they are seeking to please, veterans, are disproportionately Republicans.
退伍军人对同袍中居高不下的自杀率感到不满,正积极游说,要求特朗普兑现承诺。
Veterans, frustrated with high suicide rates among their fellow ex-service members, are lobbying aggressively to see Trump follow through.
“多亏了特朗普总统的‘曲速行动’,我们才得以为新冠推出疫苗,”朱莉安娜·默瑟说,她是一名海军陆战队退伍军人,也在纽约市举行的“视野:致幻药物透视”会议上发了言。“为什么我们不把这种‘曲速’用到这种治疗上,来拯救我们退伍军人的生命?是什么在阻止我们这样做?”格拉迪森说,实际困难和确保安全的必要性构成了障碍。他说,对于退伍军人事务部来说,“在第一年用FDA批准的致幻药物治疗四位数数量的患者将是一项挑战”。
“We were able to roll out a vaccine for Covid because of President Trump’s Warp Speed initiative,” said Juliana Mercer, a Marine Corps vet who also spoke at the Horizons: Perspectives on Psychedelics conference in New York City. “Why aren’t we warp-speeding this treatment to save our veteran lives? What’s keeping us from doing that?”Gradison said practical challenges, and the need to ensure safety, stand in the way. He said that “it’ll be a challenge” for the VA “in the first year to treat four digits worth of patients” with an FDA-approved psychedelic drug.
“毫无疑问,我们的需求将超过我们提供这些疗法的能力,”格拉迪森说。
“Our demand will exceed our ability to supply these therapies, no doubt,” Gradison said.
尽管如此,迷幻药的支持者也能指出特朗普政府带来的一些势头。特朗普4月签署行政令一周后,FDA允许三家开发迷幻药治疗方法的制药公司进行快速通道申请审查。其中一家公司Compass Pathways计划在本季度完成向该机构提交其合成裸盖菇素制剂用于治疗难治性抑郁症的申请。裸盖菇素更广为人知的名称是“神奇蘑菇”,人们使用它更多是为了消遣而非治疗。Compass预计将在2027年上半年获得批准。
Still, psychedelic enthusiasts can also point to some momentum coming out of the Trump administration. A week after Trump’s April executive order, the FDA allowed fast-track application reviews for three drugmakers developing psychedelic treatments. One, Compass Pathways,is set to finish submitting an application to the agency this quarter for its synthetic formulation of psilocybin for treatment resistant depression. Psilocybin is better known as magic mushrooms by those who use it for fun, rather than for healing. Compass anticipates an approval during the first half of 2027.
迷幻药运动对联邦行动的兴奋主导了为期三天的纽约会议的讨论,会议吸引了联邦官员、专注于迷幻药的制药公司高管、生物技术投资者、临床医生和心理健康倡导者参加。
The psychedelic movement’s excitement over the federal action dominated discussions at the three-day New York conference, which drew attendance from federal officials, top executives at psychedelic-focused drug companies, biotech investors, clinicians and mental health advocates.
“我们站在新的一天,面临着与2024年带给我们的截然不同的180度转折轨迹,”迷幻药倡导组织“美国人支持伊博格碱”首席执行官W·布莱恩·哈伯德在10月17日发言时说道,赢得了观众的掌声。伊博格碱是一种从非洲灌木中提取的迷幻药,在墨西哥广泛可得,因治疗创伤后应激障碍等病症而引起了退伍军人的兴趣。
“We stand here on a new day and a 180 degrees different trajectory than what 2024 brought to us,” W. Bryan Hubbard, CEO of the psychedelic medicine advocacy group Americans for Ibogaine, said while speaking on Oct. 17, earning applause from the audience. Ibogaine, a psychedelic drug derived from an African shrub widely available in Mexico, has drawn interest from veterans for treating conditions like PTSD.
特朗普对迷幻药的推动甚至得到了此前对该类药物持怀疑态度的人的接受。美国国家药物滥用研究所所长诺拉·沃尔科夫曾在2024年告诉参议员,她认为迷幻药医学的支持者走在了证据前面。“当人们兴奋时,他们就想开始有点相信童话了,”她说。然而,4月特朗普签署行政令时,她站在椭圆形办公室里鼓掌支持这一举措。她在最近的采访中也对这些药物给予了。
Trump’s psychedelics push has even been embraced by former skeptics of the drugs. Nora Volkow, director of the National Institute on Drug Abuse, told senators in 2024 she thought psychedelic medicine backers were getting ahead of the evidence. "When people get excited, they want to start believing a little bit in fairy tales,” she said. However, she stood in the Oval Office with Trump in April as he signed his order, applauding the effort. She’s also spoken positively about the drugs in recent interviews.
尽管迷幻药尚未达到政府监管标准,但支持其获批的人士常援引退伍军人在墨西哥接受迷幻疗法的轶事以及充满希望的临床试验数据,作为推进审批的理由。
Though psychedelics have yet to meet government regulatory standards, advocates of their approval often point to anecdotes about veterans’ experiences receiving psychedelic therapy in Mexico and promising clinical trial data as reasons to move forward.
退役陆军少将格伦·H·柯蒂斯形容,去年在墨西哥服用伊博格因后,对他的创伤后应激障碍(PTSD)和创伤性脑损伤产生了“奇迹般”的疗效。
Glenn H. Curtis, a retired Army major general, described the impact of taking ibogaine last year in Mexico as having a “miraculous” effect on his PTSD and traumatic brain injuries.
“那些部署归来后出现问题的人,甚至像我这样,20年后的今天,依然存在问题,却未曾接受过任何治疗,”作为“美国伊博格因协会”志愿者的柯蒂斯说道。
“Those same people that had issues coming home from deployments, even like myself, 20 years later, still have issues today that they have not received any kind of treatment [for],” said Curtis, who is a volunteer for Americans for Ibogaine.
退伍军人的事业在华盛顿拥有多位捍卫者。参议员蒂姆·希伊(共和党-蒙大拿州),一名曾在伊拉克和阿富汗服役的前海豹突击队队员,已表示支持,并提议立法在退伍军人事务部(VA)内设立一个办公室,专门帮助该机构为迷幻药获批做准备,并将疗法纳入患者护理。众议员卢·科雷亚(民主党-加利福尼亚州)和杰克·伯格曼(共和党-密歇根州,前海军陆战队少将)共同担任“迷幻疗法推进核心小组”联合主席,该小组最近发布了一份建议框架,旨在将经FDA批准的迷幻疗法纳入美国医疗体系。
Veterans have multiple champions in Washington for their cause. Sen. Tim Sheehy (R-Mont.), a former Navy SEAL who served in combat in Iraq and Afghanistan, has offered his support,sponsoring legislation to establish an office within the VA dedicated to helping the agency prepare for psychedelic drug approvals and integrate the therapies into patient care. Reps.
与此同时,迷幻药支持者即将在国会山失去两位杰出的倡导者。得克萨斯州共和党众议员丹·克伦肖,一名前海豹突击队队员,于3月在初选中败给挑战者,他在2023年主导推动通过立法,为现役军人接受迷幻疗法的联邦临床试验提供资金。另一位得克萨斯州共和党众议员摩根·卢特雷尔,一名前海豹突击队队员,曾因训练中遭受的创伤性脑损伤前往墨西哥寻求伊博格因治疗,他在决定不寻求连任后,将于1月离开国会。
Lou Correa (D-Calif.) and Jack Bergman (R-Mich.), a former Marine Corps general, co-chair the Psychedelics Advancing Therapies Caucus, which recently released a suggested framework for implementing FDA-approved psychedelic therapies into the U.S. health care system. At the same time, psychedelic enthusiasts are set to lose two prominent advocates on Capitol Hill. Texas GOP Rep. Dan Crenshaw, a former SEAL ousted by a primary challenger in March, led a successful push in 2023 to pass legislation that funded federal clinical trials on psychedelic therapies for active-duty military members.
“行政命令往往会随着形势的起伏而消失,我只是不希望这样的事情被废除,”拉特雷尔对《政治报》说,并强调他希望国会能将特朗普的行政命令写入法律。
Another Texas Republican, Rep. Morgan Luttrell, a former SEAL who sought ibogaine treatment in Mexico for a traumatic brain injury he incurred during training, is retiring from Congress in January after deciding not to seek reelection.
退伍军人是可靠的共和党票仓,2024年有61%的人投票支持特朗普而非卡玛拉·哈里斯。
“Executive orders have a tendency to go away as the tides ebb and flow, and I would just hate for something like this to be removed,” Luttrell told POLITICO, emphasizing his desire for Congress to codify Trump’s executive order.
退伍军人事务部在华盛顿率先推动扩大迷幻疗法的可及性。该部参与了20项迷幻药物临床试验,并且是最早推出Spravato的大型医疗系统之一。Spravato是经美国食品药品监督管理局批准、使用艾司氯胺酮治疗抑郁症的药物,艾司氯胺酮是氯胺酮中的一种化学成分。氯胺酮是一种麻醉剂,因其精神活性作用而常被称为迷幻药,目前是唯一获批用于医疗用途的类迷幻药物。特朗普政府官员表示,他们希望很快会有更多药物获批。
Veterans are a reliable Republican voting bloc, with 61 percent voting for Trump over Kamala Harris in 2024. The VA has led the push in Washington to advance access to psychedelic therapy. It’s involved in 20 psychedelic clinical trials and was one of the first major health care systems to roll out Spravato, an FDA-approved treatment for depression using esketamine, a chemical component found in ketamine. Ketamine — an anesthetic frequently referred to as a psychedelic due to its psychoactive effects — is currently the only psychedelic-like drug approved for medical use. Trump administration officials say they hope more will be approved soon.
“如果药物安全有效,我们希望看到它获批,原因在于存在心理健康危机,”美国卫生与公众服务部副总法律顾问马特·佐恩对《政治报》说。
“We want to see the drug approved if it's safe and effective, and the reason why is because there's a mental health crisis,” Matt Zorn, deputy general counsel at the Health and Human Services Department, told POLITICO.
尽管联邦政府和倡导团体持续努力支持退伍军人群体,这一人群的心理健康问题长期存在。退伍军人事务部援引研究结果称,在该部接受治疗的退伍军人中,有23%的人一生中某个时候患有创伤后应激障碍,而在未通过该部寻求治疗的退伍军人中这一比例为7%。该机构指出,战区部署、训练事故和军中性创伤是可能导致军人患上创伤后应激障碍的一些主要情形。
Despite the federal government and advocacy groups’ ongoing efforts to support the veteran community, mental health issues among the population have long persisted. The VA has cited research finding that 23% of veterans that receive care through the VA had PTSD at some point in their lives, compared to 7% of veterans who don’t seek care through the VA. The agency has pointed to war zone deployment, training accidents and military sexual trauma as some of the main situations that could lead to a military service member developing PTSD.
美国退伍军人的自杀率比普通成年人口高出约57%,平均每天有近18名退伍军人自杀身亡。
U.S. veterans take their own lives at a rate roughly 57% higher than the general adult population, with an average of nearly 18 veterans dying by suicide every day.
尽管迷幻药物爱好者觉得获得美国食品药品监督管理局(FDA)批准从未如此接近,但联盟内部在治疗应采取何种形式的问题上分歧日益扩大。制药公司和生物技术投资者在资金上支持“药物优先”模式,但一些临床医生(主要是心理治疗师)和议员认为,迷幻药物与心理治疗配合使用时,治疗精神健康状况更安全、更有效。
While psychedelic enthusiasts feel closer than ever to scoring an FDA approval, cracks within the coalition have widened over what treatment should look like. Drugmakers and biotech investors have financially supported a drug-first model but some clinicians, mainly psychotherapists, and lawmakers argue that psychedelics are safer and more effective for treating mental health conditions when paired with psychotherapy.
“这不是吃一颗药丸然后说‘我明天就会痊愈’,”科雷亚在9月的一次新闻发布会上说。“有前期准备、精神科和心理辅导、实际治疗,然后是治疗后的心理和精神科治疗,这样才能非常有效,达到最有效。”这一矛盾在FDA于2024年拒绝Resilient Pharmaceuticals(当时名为Lykos Therapeutics)的MDMA辅助治疗申请时达到顶点。
“This is not dropping a pill and saying ‘I'm going to be cured tomorrow,’” Correa said during a press briefing in September. “There’s pre-preparation, psychiatric, psychological counseling, the actual treatment and then post-treatment psychological, psychiatric treatment in order to be very effective, most effective.”This tension came to a head with the FDA’s 2024 rejection of a MDMA-assisted therapy application from Resilient Pharmaceuticals, then known as Lykos Therapeutics.
该机构的主要担忧之一是,监管人员难以确定临床改善中有多少来自MDMA的作用,多少来自治疗中密集的谈话治疗环节。该机构还提到了对安全数据缺失、试验操纵指控以及治疗从业者可能存在不当行为的风险的担忧。
Among the agency’s chief concerns was that regulators struggled to determine how much of the clinical improvement came from the effects of MDMA versus the intensive talk therapy component of the treatment. The agency also cited concerns about missing safety data, trial manipulation accusations and the potential risk for misconduct among therapy practitioners.
但Compass的迷幻药物治疗不包含谈话治疗环节,这使得FDA更容易评估该药物的疗效。
But Compass’ psychedelic therapy doesn’t include a talk therapy component, allowing the FDA to more easily evaluate the efficacy of the drug.
“患者有需求,而这是一个已被充分研究的药物类别。我们正在确保满足所有标准,以便患者能够安全地接受治疗,”Compass首席商务官洛里·恩格尔伯特在最近的一次采访中告诉《政客》。
“Patients are in need, and this is a class that’s been well studied. We’re making sure that all standards are met so that patients can receive treatment safely,” Lori Englebert, Compass’ chief commercial officer, told POLITICO in a recent interview.