Montana’s plan to become an experimental medical hub just pushed forward

蒙大拿州成为实验性医疗中心的计划取得新进展

EXECUTIVE SUMMARY As of this week in Montana, any biotech company with an experimental drug has a clear path to selling it to consumers. Companies whose drugs have been through preliminary testing—sometimes in as few as 10 healthy people—can pay $12,500 to apply to a newly established review board for approval. Once its treatment is rubber-stamped, the company can set the price of the drug and sell it via experimental treatment clinics, the first of which is likely to be up and running around the end of this year. 执行摘要 本周起，在蒙大拿州，任何拥有实验性药物的生物技术公司都有了向消费者销售产品的明确途径。那些药物已通过初步测试（有时仅在 10 名健康人身上进行过测试）的公司，可以支付 12,500 美元向新成立的审查委员会申请批准。一旦其疗法获得批准，公司即可自行定价，并通过实验性治疗诊所进行销售，首批诊所预计将于今年年底左右投入运营。

Montana’s latest right-to-try legislation is unique. While other jurisdictions with similar laws limit access to drugs to people with terminal illness, in Montana access is theoretically available to anyone who gives informed consent and can pay. That includes people desperate for treatments for rare diseases. It also includes those who are interested in longevity and want to try out drugs pitched as preventive therapies. 蒙大拿州最新的“尝试权”（right-to-try）立法非常独特。虽然其他拥有类似法律的司法管辖区将药物获取权限仅限于绝症患者，但在蒙大拿州，理论上任何能够提供知情同意并支付费用的人都可以获得这些药物。这包括那些急需罕见病治疗方案的患者，也包括那些对长寿感兴趣、希望尝试被宣传为预防性疗法的药物的人群。

The state’s Department of Health and Human Services recently finalized rules to implement the law. The rules stipulate that patient consumers provide fully informed consent and that each application be reviewed by a board that includes a Montana-certified doctor, expert scientists, and an ethicist. Supporters of the law stress that they want the process to be responsible. “It will be done in a very rigorous way, with qualified medical professionals and appropriate oversight,” says Matt Kaeberlein, a scientist on the first board, which was formed independently of the state health department. 该州卫生与公众服务部最近敲定了实施该法律的细则。规定要求患者消费者必须提供充分的知情同意，且每项申请都必须由一个包含蒙大拿州认证医生、专家科学家和伦理学家的委员会进行审查。该法律的支持者强调，他们希望这一过程是负责任的。首届委员会（独立于州卫生部门成立）的科学家成员马特·凯伯莱恩（Matt Kaeberlein）表示：“这将以非常严谨的方式进行，由合格的医疗专业人员进行适当的监督。”

But other experts are worried about the potential for harm in selling unproven treatments to people without oversight from the US Food and Drug Administration. “I would be concerned,” says Aaron Kesselheim, a professor of medicine at Harvard Medical School with expertise in health policy and drug regulation. There has been a growing movement to make unapproved drugs more accessible in the US. But the story of Montana’s law is unique. It’s been driven and drafted by longevity enthusiasts instead of the usual libertarian and patient groups. 但其他专家担心，在没有美国食品药品监督管理局（FDA）监管的情况下向公众销售未经证实的疗法存在潜在危害。哈佛医学院医学教授、卫生政策与药物监管专家亚伦·凯塞尔海姆（Aaron Kesselheim）表示：“我会感到担忧。”在美国，让未经批准的药物更容易获得已成为一种日益增长的趋势，但蒙大拿州法律的故事却很独特。它是由长寿倡导者而非通常的自由意志主义团体或患者组织推动和起草的。

An unusual origin story

不寻常的起源故事

Montana first passed a right-to-try law in 2015. In 2023, with the support of state senator Ken Bogner, the state expanded the law to include all patients, not those just with terminal disease. Last year, Bogner told MIT Technology Review that his vision was to focus “more on preventative medicine” rather than “just treating diseases once they show up.” Bogner says he had “started working on a bill” that would become the 2023 law when the Alliance for Longevity Initiatives (A4LI), a nonprofit “dedicated to advancing legislation and policies aimed at increasing healthy human lifespan,” got in touch. 蒙大拿州于 2015 年首次通过了“尝试权”法。2023 年，在州参议员肯·博格纳（Ken Bogner）的支持下，该州扩大了法律适用范围，涵盖所有患者，而不仅仅是绝症患者。去年，博格纳告诉《麻省理工科技评论》，他的愿景是更多地关注“预防医学”，而不是“仅仅在疾病出现后才进行治疗”。博格纳表示，当“致力于推动旨在延长人类健康寿命的立法和政策”的非营利组织“长寿倡议联盟”（A4LI）与他联系时，他已经开始起草后来成为 2023 年法律的法案。

A4LI connected Bogner with others who helped draft the bill and testified in support of it. Once that law was in place, the tech entrepreneur and longevity enthusiast Niklas Anzinger got involved. Anzinger has been working to establish a jurisdiction to fast-track the search for drugs that might deliver radical life extension. He is based in Próspera—a private city and “special economic zone” in Roatán, Honduras, which is already home to a separate clinic that sells experimental stem-cell and gene therapies. A4LI 将博格纳与其他人联系起来，这些人协助起草了该法案并出庭作证支持。法律生效后，科技企业家兼长寿倡导者尼克拉斯·安辛格（Niklas Anzinger）参与了进来。安辛格一直致力于建立一个司法管辖区，以加速寻找可能实现彻底延长寿命的药物。他常驻洪都拉斯罗阿坦岛的私人城市兼“经济特区”Próspera，那里已经有一家销售实验性干细胞和基因疗法的诊所。

Anzinger founded a community there called Infinita City; he has also founded an investment company and a “service providing” company, both of which include the name Infinita. Over the last couple of years, Anzinger has switched his focus to the US. “Now we think that Montana is a better model, because it’s building on … existing regulatory precedents,” he says. Once Montana’s 2023 law was passed, he adds, he worked with a handful of unnamed biotech companies to draft a second bill—one that laid out the specific terms under which clinics can offer unapproved drugs. 安辛格在那里创立了一个名为“无限城”（Infinita City）的社区；他还创办了一家投资公司和一家“服务提供”公司，两者的名称中都包含“Infinita”。过去几年里，安辛格将重心转向了美国。他说：“现在我们认为蒙大拿州是一个更好的模式，因为它建立在……现有的监管先例之上。”他补充说，蒙大拿州 2023 年的法律通过后，他与几家未具名的生物技术公司合作起草了第二项法案，该法案规定了诊所提供未经批准药物的具体条款。

That law was passed in April 2025 and adopted the following month. Since then, Anzinger, Bogner, and others have been waiting for the state’s Department of Health and Human Services to finalize specific rules for treatment centers—a set of operational guidelines and requirements that any clinic offering treatments unapproved by the FDA must meet under Montana’s law. “The rules have been taking a very long time,” says Anzinger. “Then on Friday, we heard they were effective … from Saturday [July 25].” The rules have since been published online. 该法律于 2025 年 4 月通过，并于次月生效。此后，安辛格、博格纳等人一直在等待州卫生与公众服务部敲定针对治疗中心的具体规则——即根据蒙大拿州法律，任何提供 FDA 未批准疗法的诊所必须满足的一套操作指南和要求。安辛格说：“这些规则制定得非常慢。然后周五我们听说它们从周六（7 月 25 日）起生效了。”目前，这些规则已在网上公布。

Following the rules

遵循规则

With the new rules in hand, Anzinger and his colleague Stephen Martin, Infinita’s US lead, got to work. The first step was to establish an independent experimental treatment review board—a panel of five experts to evaluate applications for access. Anzinger and Martin started recruiting candidates months ago. The state’s first board, named the Montana ETRB, was officially announced by Infinita earlier this week. For the time being, it is the state’s only review board, although Anzinger says that other groups are free to establish their own. 拿到新规则后，安辛格和他的同事、Infinita 美国区负责人斯蒂芬·马丁（Stephen Martin）开始着手工作。第一步是建立一个独立的实验性治疗审查委员会——一个由五名专家组成的评估小组，负责评估获取申请。安辛格和马丁几个月前就开始招募候选人。本周早些时候，Infinita 正式宣布了该州首个委员会，名为“蒙大拿州实验性治疗审查委员会”（Montana ETRB）。目前，这是该州唯一的审查委员会，尽管安辛格表示其他团体也可以自由建立自己的委员会。

After Bogner raised concerns that the board’s website wrongly implied that it was an official state body, the site was updated to note that “It is a private service run by Montana Governance Services Inc.” That company is “a local Montana registered entity, but it is under the Infinita umbrella,” says Anzinger. Infinita will pay board members a flat fee, funded by the $12,500 companies will have to pay to have their applications reviewed. Anzinger stresses that the board members, and their decisions, will be independent of Infinita. 在博格纳提出该委员会网站错误地暗示其为官方州机构的担忧后，网站进行了更新，注明“这是一个由 Montana Governance Services Inc. 运营的私人服务机构”。安辛格表示，该公司是“一家在蒙大拿州注册的本地实体，但隶属于 Infinita 旗下”。Infinita 将向委员会成员支付固定费用，资金来源则是公司申请审查时必须支付的 12,500 美元。安辛格强调，委员会成员及其决策将独立于 Infinita。

In accordance with the rules, the board includes a Montana-licensed doctor: James Burke, an oncologist. It also includes a bioethicist: Jessica Flanigan, a libertarian who is known for her strong views in support of self-medication and her book Pharmaceutical Freedom. The other three members are familiar faces in the longevity community—all of whom are well respected in the field. “When we looked at our own network, these were some of the best guys,” says Martin. They include Felipe Sierra, who formerly held a senior role at the National… 根据规定，该委员会包括一名蒙大拿州执业医生：肿瘤学家詹姆斯·伯克（James Burke）。它还包括一名生物伦理学家：杰西卡·弗拉尼根（Jessica Flanigan），她是一位自由意志主义者，以支持自我用药的坚定观点及其著作《药物自由》（Pharmaceutical Freedom）而闻名。其他三名成员也是长寿社区的熟面孔，他们在该领域都备受尊敬。马丁说：“当我们审视自己的人脉网络时，这些人就是最优秀的人选。”其中包括曾在国家……担任高级职务的费利佩·塞拉（Felipe Sierra）。