
美国正面临心理健康危机,而令人遗憾的是,我们的联邦政府进展缓慢。每天,超过130名美国人死于自杀,其中包括每天超过20名退伍军人。迷幻剂辅助疗法已成为治疗难治性抑郁症、创伤后应激障碍、物质使用障碍和广泛性焦虑障碍的一种有希望的新选择。但我们的退伍军人和其他美国人并未在美国接受这些疗法,而是出国寻找这些常常能挽救生命的迷幻剂辅助疗法。
America faces a mental health crisis, and sadly, our federal government is not keeping pace. Every day, over 130 Americans die by suicide, including over 20 veterans per day. Psychedelic-assisted therapies have emerged as a promising new alternative for treatment-resistant depression, post-traumatic-stress disorder, substance use disorders, and generalized anxiety disorder. But instead of receiving these therapies here in the U.S., our veterans and other Americans are going abroad in search of these often lifesaving psychedelic-assisted therapies.
我们感谢特朗普政府加速这些疗法研究的工作,以及食品药品监督管理局对多种基于迷幻剂的药物产品授予突破性疗法认定,包括裸盖菇素和MDMA。但联邦层面仍需做更多工作,以确保安全有效的疗法能够惠及最需要的人。两年前,我们的两党国会迷幻剂推进疗法或“PATH”党团发出正式信息请求,询问如何安全有效地将迷幻剂医学融入美国医疗体系的反馈意见。
We are grateful for the Trump administration’s work to accelerate research on these therapies and the Food and Drug Administration’s granting of Breakthrough Therapy designation to multiple psychedelic-based drug products, including psilocybin and MDMA. But more needs to be done at the federal level to ensure safe and effective therapies reach the people who need them the most. Two years ago, our bipartisan Congressional Psychedelics Advancing Therapies or "PATH" Caucus issued a formal request for information, asking for feedback on how we can safely and effectively integrate psychedelic medicine into the U.S. health care system.
受访者明确表示,迷幻剂不一定是灵丹妙药。但如果在安全且结构化的环境中提供,它们对美国患者可能具有变革性。而这正是我们需要新联邦政策的原因——这些政策应在医疗环境中为这些治疗的安全使用制定全国性标准。我们需要一个国家框架,以确保安全和公平的获取途径。我们PATH党团的信息请求回应指出了一条务实之路:在建立安全、伦理和公平的强有力防护措施的同时,加速合法的医学发展。这始于服务提供和从业者资质认证的全国性标准。
Respondents made clear that psychedelics are not necessarily magic bullets. But if delivered in a safe and structured environment, they can be transformative for American patients. And that is exactly why we need new federal policies that create nationwide standards for the safe use of these treatments in medical settings. We need a national framework to ensure safe and equitable access. Responses to our PATH Caucus request for information point toward a pragmatic path of accelerating legitimate medical development while building strong guardrails for safety, ethics and equity. That begins with national standards for service delivery and practitioner credentialing.
各界利益相关者一致认为,在即将到来的FDA对迷幻疗法的批准之前,我们的国家需要建立指导和验证系统。我们还需要为迷幻药物制定标签要求,并将“心态与环境”、危机应对以及会前和会后整合支持的最佳实践编纂为规范。如果我们希望充分发挥迷幻药物的公共卫生潜力,国会和联邦机构也必须正面应对这些问题。
Stakeholders across the spectrum agree that our nation needs guidance and verification systems in place before the coming FDA approvals of psychedelic therapies. We also need labeling requirements for psychedelic medicine and the codification of best practices for “set and setting,” crisis response, and pre- and post-session integration support. If we want to fulfill the full public health potential of psychedelic medicine, Congress and federal agencies also need to tackle these issues head-on.
迷幻辅助疗法进入美国医疗体系不再是“是否”的问题,而是“什么时候”的问题。所有注意力必须集中在如何安全有效地将其纳入医疗体系,以便有需要的患者能够获得这些治疗。我们必须通过制定一套连贯的标准来抓住这一时机,以保护患者、实现公平获取,并为每一位遭受严重身心健康挑战的美国人带来生活品质的提升。
It’s no longer a matter of if psychedelic-assisted therapies will enter the American health care system, but when. All attention must focus on how we can integrate them safely and effectively, so that patients in need can access these treatments. We must seize this moment by establishing a coherent set of standards that protect patients, deliver equitable access, and yield life-enhancing benefits for every American suffering from severe mental and physical health challenges.
杰克·伯格曼代表密歇根州第一国会选区,是一名退役海军陆战队中将。卢·科雷亚代表加利福尼亚州第四十六国会选区。两位议员均担任国会PATH小组的联合主席。
Jack Bergman represents Michigan’s 1st Congressional District and is a retired Marine Corps lieutenant general. Lou Correa represents California’s 46th Congressional District. Both members serve as co-chairs of the Congressional PATH Caucus.