「公共健康太破碎了」：Vinay Prasad 谈离开 FDA、对照臂与儿童死亡备忘录

这期《The Reason Interview》不是一份给读者开药或改接种计划的操作手册。主持人是 Reason 的 Zach Weissmueller（不是平时出镜更多的 Nick Gillespie），嘉宾是血液肿瘤科医生、加州大学旧金山分校（UCSF）流行病学与生物统计学教授、前 FDA 生物制品评价与研究中心（CBER）主任 Vinay Prasad。节目围绕他从「新冠时期公共健康建制批评者 → 进入 FDA 成为局内人 → 再离开」这条轨迹展开，重点追问三件事：他在局里看到了什么；他如何为自己任内最有争议的决定辩护；以及公共健康机构还能否重新赢得信任。

读者如果只想要「该不该打某种疫苗」的结论，这期不会直接给出；如果你想听一位曾同时掌握临床试验批评与监管实权的医生，怎样把「合适的药、合适的人、合适的时间」这条原则落到 Moderna 流感 mRNA 申请、儿童 COVID 疫苗死亡归因、基因疗法限制和「旋转门」等问题上，这约 71 分钟的访谈信息密度很高。

Reason 在导语里把本期概括为：Prasad 曾以批评公共健康建制闻名，后来成为建制的一部分，再在 CBER 主任任上争议离任；访谈回应了机构内部对他管理风格的批评、Wall Street Journal 把他写成「穿着 MAHA 外衣的 Bernie Sanders 信徒」，以及保守派舆论场里称他为「破坏者」等说法。1

Vinay Prasad 的公开履历把临床、证据方法与政策批评叠在一起。他在个人网站上介绍自己为血液肿瘤科医生、UCSF 流行病学与生物统计学教授，实验室研究癌症药物、卫生政策、临床试验与决策；著有 Ending Medical Reversal（与 Adam Cifu 合著）和 Malignant，并长期主持肿瘤学播客 Plenary Session、在 Substack / YouTube 上写作。3

这与本期谈话的对应关系很直接：他不是从单一党派口号进入监管，而是带着「对照臂是否合理、替代终点是否过弱、强制政策是否超出证据」这类临床试验批评者的问题清单进入 FDA。他在节目中说，自己和 Marty Makary、Jay Bhattacharya 批评疫情应对的许多方面，但并不走到最极端批评者的位置；进入政府后，他自认一年里学到的「世界如何运转」，超过此前十年。

读者需要同时记住两层边界：他谈 Fauci 日记、实验室泄漏、犯罪与赦免时，是在陈述自己的判断与解读；他谈 Moderna 申请、内部备忘录和离任后公开报告时，Reason 导语也并列给出了可核对的媒体与文件线索。摘要会分开写，避免把「嘉宾主张」写成「已成定论的事实」。

Weissmueller 开场问：旧建制（Walensky、Fauci、Collins 等）被换下，Marty Makary、Jay Bhattacharya 与 Prasad 等「异议者」进入，进入官僚机构时有没有犹豫。

Prasad 的第一反应不是个人英雄叙事。他说 FDA 大约有 1.8 万人，他们大概只换了 2%–4%；在他们到任前，DOGE 已经裁掉或许两三千人，但「系统大体仍是原来的系统」。他承认这是一次冒险和学习，也说自己改进了部分「可能持久」的做法，并尝试改进另一些「未必持久」的部分。

这句话定下了整期的语气：他不把人事更替本身当成公共健康已经重生。后面谈到疫苗日程可能在旧金山与得州分化、职业公务员构成「第四分支」时，这条线会再次出现。

节目前半段长时间停在 Anthony Fauci。Prasad 的核心指控不是单一政策对错，而是他认为主流媒体不愿诚实评价 Fauci 的遗产，而日记暴露了公开表述与私下判断的落差。

他按几条线展开：

关于 gain-of-function（功能获得研究） 与犯罪问题，Prasad 的立场非常硬。他提到 Fauci 2011 年在 Washington Post 撰文为这类研究辩护，并称其在奥巴马时期限制背景下仍资助 EcoHealth；他认为这构成犯罪，且总统赦免覆盖到那一时期本身就说明签署方也按犯罪来处理。这是嘉宾判断，不是法庭判决；节目没有出示完整司法文件链。

对病毒起源，他用「汤里有没有尿」的类比：生物学证据难拿全时，还要看情报判断。他指出 CIA、能源部、FBI 等有实验室泄漏评估；Fauci 日记里写到被拉进 SCIF 听取中方通讯截获；Fauci 自己也把武汉海鲜市场最多写成「放大事件」而非起源。Prasad 的倾向是：公众未必看得到完整证据，但「答案大概是实验室泄漏」；至于恶意还是意外，他留给听众自己想。

阅读提示：这一段情绪强、断言多。它适合用来理解 Prasad 如何组织批评，不适合直接当作已结案的调查结论。若你关心起源与日记原文，需要回到 Rand Paul 公布材料与原始日记文本核对。

谈完旧人，Weissmueller 问：在 RFK Jr. 领衔 HHS 的氛围里，新公共健康该长成什么样。

Prasad 说自己在 FDA 的授权其实很窄——只管生物制品——但希望仍是：公共健康力求诚实，权力用得克制，并保持谦逊；它本可以追求跨党派，实际上却越来越像由左翼意识形态主导的学科，结论越来越离谱。他不认为一年人事调整已经改变多少；改革「真正发生」很难，未来更可能碎成多套公共健康叙事。

具体到疫苗，他反复用同一句框架：

他反对的是媒体与建制里把「所有疫苗」说成永远完美、越多越好、不可质疑的教条。例子包括：

这是节目里最适合用来理解 Prasad 监管哲学的一段。

他回忆 Moderna 最初申请：希望对 50 岁以上 获得常规批准，且不再承担上市后疗效承诺；依据是新疫苗对「较老疫苗」的随机对照。问题在于：过去约十年，美国 65 岁以上标准已是 高剂量或佐剂流感疫苗，普通旧苗在专家和药房实践里都不够。他把用「非最佳可用标准」做对照臂，说成不符合「充分且良好对照」的法定要求，也认为对对照臂受试者不道德——他们得到的护理，比走进 MinuteClinic / CVS / Walgreens 还差。

因此他发出 refuse-to-file（拒绝受理归档）。后来接受的是拆分后的再提交：50–64 岁常规批准，65 岁以上加速批准并附带确证疗效研究。他离开后 FDA 已批准部分人群使用；他大体支持「比最初进门的申请更好」，但强调媒体几乎从不区分「原提交」与「按年龄拆分的再提交」，也不追问 67 岁对照臂到底有没有真正疗效数据（他称其更多是免疫桥接、抗体滴度，证据薄弱）。

他还补了一刀：有人喜欢 mRNA 流感平台，是因为理论上比蛋基生产改得更快——这是可以正式检验的假说，却几乎没有人真去在同一季比较「更晚锁定抗原的 mRNA 苗」与传统苗。

标题里的那句「Public health in this country is so broken」，正是他在区分「80 岁从未感染者该不该在 2021 年 2 月接种」与「2022 年已感染的健康 7 岁孩要不要再打」时说出来的：公共健康无法欣赏这些区分。

Weissmueller 引用他任内一份内部备忘录大意：疫苗安全评估人员发现至少 10 名儿童在接种 COVID-19 疫苗后、并因疫苗死亡；FDA 将首次承认疫苗导致美国儿童死亡。离任约一个月后公开的官方报告则写：确定关联为 0，可能 5 例，很可能 2 例。1

Prasad 的回应分三层：

他希望公众带走的不是「疫苗很恐怖」，而是：对健康儿童、尤其大学生强制 COVID 接种是坏政策；平均而言，大学生群体可能被该政策伤害。他批评建制用「对面有人说芯片」当借口，去否认真实的安全问题，而不是诚实承认「20 岁男生刚得过 COVID、要住宿舍，不必强制再打」。

边界：Reason 导语写明，离任后公开报告是 0 例「确定」、5 例「可能」、2 例「很可能」。Prasad 主张草稿曾是 10、后被改写——这是他的说法，需要对照 Ron Johnson 公开文件与 FDA 最终文本，摘要无法替读者完成仲裁。

Weissmueller 问：他想抬高疫苗与基因疗法审批门槛，是否与特朗普政府的放松管制冲动冲突。

Prasad 先拆 Right to Try：有权尝试，不等于强制医保按天价买单。再拆 稀有病 / 基因疗法 vs 全民疫苗：对罕见酶缺陷等，他们更灵活，甚至允许在无随机对照的情况下给充分批准；疫苗多是面向健康儿童的一刀切产品，他认为门槛应更高，且长期被压低有政治原因——左翼更倾向「凡疫苗皆好」。

在 FDA 工作后，他自称更谨慎对待新疗法，也「更自由意志主义」一点：可以想象第三方像 Consumer Reports 那样给产品打不同质量印记，让美国人有更大尝试弹性，并用自己的钱承担更多风险偏好差异。他质疑的，是华盛顿郊区一个单一机构，能否替所有人设定同一套安全—疗效平衡。

具体产品上：

Wall Street Journal 批评他限制某款已有人死亡的产品时，他反驳：药仍在市，只是收紧了适用；真正「一人推翻审评团队」的先例是前任 Peter Marks 的 override memo。他提到第一次短暂离任与 Replimune 等争议时间重合，被 Laura Loomer 等打成 saboteur，但被问「是不是因此被推出去」时，他只说「时间点很有意思」，不再展开。

谈到 Jim O'Neill 一类更彻底的自由意志主义方案（例如把安全与疗效拆开、让市场更多说话）时，Prasad 用汽车类比：

他担心只靠早期「不爆炸」就放行：一种抗抑郁药若让心梗率上升 0.5–4 个百分点，在最先用药的高度选择人群里可能很难发现，却会在人群层面造成大伤害。因此他对「大幅放弃人群层面长期安全监测」持保留。

对 Marty Makary 推动的贝叶斯方法，他承认能加速上市、跨适应症借力，但提醒「加速」与「抓到微小危害」不是同一件事。

对 Anthropic CEO Dario Amodei 批评 FDA 拖慢生物医药，以及医疗 AI 监管，他同意一核：FDA 想管智能手表、数字健康、医生用来查病的 App，技术迭代速度会超过监管判断力；他不认为政府应去规定医生下午看诊时能用哪些学习工具。他更倾向：政府直接监管 AI 医疗产品容易管错，更应把重点放在它能管好的传统药械问题上。

第二次永久离开时，STAT 等报道写到他与职业官僚冲突、管理风格被指造成不信任。Prasad 反击报道生态：

对 MAHA 是否再次被大药厂推开，他说：一切政府改革都会撞上「威胁很有钱的人的利润」这条天花板；MAHA 能成功的地方，是金钱与使命同向的地方；他们当时所在的赛道，钱与使命经常反向，所以是一场上坡战。

谈到 旋转门：他点名 Peter Marks 后来与礼来疫苗业务的关联、Ashish Jha 在倾向实验室泄漏判断前后创办相关公司、Scott Gottlieb 以「前 FDA 局长」身份被引用同时是辉瑞董事等。他认为 FDA 多数人诚实，但少数人决策时确实看着「卸任后去哪家公司」。

有没有「卸任后冷却期」解法？他坦白没答案：政府薪酬差、医生难维持门诊；他最怀念的是诊所——「你可以撤销我在 FDA 做的一切，撤不销我上周门诊做的事」。若再砍掉行业再就业，可能没人愿来。

他仍说高兴去过 FDA：很少有工作能让人亲眼看见以前只在论文里读到的机制；这种机会一生一次。

Weissmueller 问：是否到了重新信任公共健康的时候。Prasad 连说几个 “no way”。

要重建信任，他觉得也许已经不可能：社会碎片化太深。一边有人坚称 Fauci「在当时信息下做到最好、毫无错误」；一边他只举一个小例子——要求 24 个月幼儿全天在托儿所戴布口罩——就认为对方立场站不住。他还举猴痘期间有人建议几乎所有大学生接种、甚至因猴痘让孩子在学校戴口罩等，认为完全脱离传播机制。

即使 RFK Jr.、Jay Bhattacharya 仍在联邦体系高层，他也不乐观会有多大「自上而下」改变。去政府前有人告诉他存在「职业公务员第四分支」，他以前不信，现在「非常确定」：大量治理发生在少数偏蓝县域的职业队伍里，对国会与总统都缺乏问责。他预期不信任会继续增长，公共健康会继续碎裂。

下一步，他用玩笑挡掉「去礼当疫苗副总裁 / 去 Peter 那边」的联想，说自己回到诊所查房、做 YouTube、为 Sensible Medicine 和自己的 Substack 写作，并「好好休息，不急着上下一件事」。

这期最值得带走的结构，不是某一句口号，而是 Prasad 反复使用的同一把尺：适应症、年龄、感染史、对照臂和强制的第三方收益是否写清楚。尺的一边，他拒绝「凡疫苗皆神圣」；另一边，他也拒绝「凡建制皆谎言」的对称简单化——至少在他自己的叙述里，对老年人 COVID 疫苗、对罕见病灵活审批、对多数 FDA 工作人员的评价，仍留下肯定空间。

节目没有证明实验室泄漏已经司法定案，没有证明儿童 COVID 疫苗死亡「确定」例数的最终官方数字被篡改到哪一步，也没有给出可复制的监管改革施工图。它提供的是一位前 CBER 主任的内部视角与自我辩护。读者可以用它决定：要不要再花完整 71 分钟听原片，并对照原始备忘录、FDA 报告与临床试验文件，自己把争议点钉牢。

以下为本期约 71 分钟访谈的完整逐字稿。英文来自 Reason 官方节目页刊出的 AI 生成稿（页面提示请对照音频核对）；中文为对照译文。按讲话人 Zach Weissmueller 与 Vinay Prasad 分段，时间轴约每 10 分钟标注一次。1

Vinay Prasad went from COVID-era public health establishment critic to public health establishment insider and back out again. He is a physician, an author, a professor at the University of California, San Francisco, and former director of the Center for Biologics Evaluation and Research at the FDA. Vinay Prasad, thank you for talking to Reason today.

Vinay Prasad 从新冠时期公共健康建制的批评者，变成了公共健康建制的局内人，后来又再度出局。他是医生、作者、加州大学旧金山分校教授，也是 FDA 生物制品评价与研究中心（CBER）前主任。Vinay Prasad，感谢你今天接受 Reason 的采访。

It's good to be back with you.

很高兴再和你聊。

So, we had this clearing out of the old guard, the Walenskys and Faucis and Collinses, and this replacement with the new guard, the COVID dissidents such as yourself, Marty Makary, Jay Bhattacharya. What was it like, and did you have any misgivings about stepping away from the role of academia and sort of outside critic and into the public health bureaucracy?

旧建制被清出——Walensky、Fauci、Collins 这些人——换成了新冠时期的异议者，比如你、Marty Makary、Jay Bhattacharya。进入公共健康官僚体系是什么感觉？你对离开学术与外部批评者角色、走进这套体系，有没有过犹豫？

So, I guess one thing to point out is that maybe we changed 4 percent, 2 percent of the FDA. I mean, the FDA is an 18,000-person agency. There's tens of thousands of people still there. Before Marty, the commissioner, and I got there, DOGE had just struck, and maybe they got rid of a couple thousand people. But I think one thing to point out is the system is largely the same as it's always been. And then I think the next thing I'd point out is there are critics of the COVID pandemic response, and then there are critics. And although Marty, Jay, and I are critics of many aspects of the response, I think we don't go as far as some of the most extreme critics out there. So am I glad I did it? Yes, I think I'm glad I did it. It was an adventure. It was a learning experience. I feel like I learned more in one year than I've learned in the prior decade about how the world works. And I'm glad to have improved, I think, some aspects of government, which I think will be enduring, and at least tried to improve other aspects of government, which may not be enduring.

首先要指出的是，我们或许只换掉了 FDA 的 4%、2%。FDA 是一个大约 1.8 万人的机构，还有成千上万的人仍在那里。在 Marty（局长）和我到任之前，DOGE 刚动过刀，也许裁掉了两三千人。但我想强调：系统大体仍和以前一样。其次，疫情应对的批评者之间也有差别。Marty、Jay 和我批评应对的许多方面，但不会走到一些最极端批评者那么远。我高兴自己去做了吗？是的。那是一次冒险，也是一次学习。我觉得这一年里学到的「世界如何运转」，超过此前十年。我很高兴改进了政府的一些方面——我认为这些会持久——也至少尝试改进了另一些未必持久的方面。

And yeah, I want to ask you a little bit about—or actually quite a bit about—what you learned from that experience. But first, let's stay on the context of that era, that transition. And I think the person who personified kind of the old guard was Anthony Fauci, and he's recently been in the news because he appeared in front of Congress, yet again pleading the Fifth, as Rand Paul kind of exposed or published his diaries. What did those diary entries reveal to you about Fauci's character, the way he was operating through that time?

我想多问问你从那次经历里学到了什么。不过先停在那个时代的过渡语境。我认为旧建制的人格化代表是 Anthony Fauci。他最近又上新闻：再次在国会作证时援引宪法第五修正案，而 Rand Paul 披露或公布了他的日记。这些日记条目让你对他的性格、以及他当时如何运作，看出了什么？

I think that Fauci has made a lot of serious errors. And I think probably the greatest news story is that the mainstream media, I think, refuses to be honest about his legacy. Anthony Fauci was in his late 70s when the pandemic began. And had he retired, you know, at a ripe old age of 75, I think he would be leaving behind a stellar legacy. But he continued. He pushed it. He stayed through the whole pandemic, and he was the face of many things that I think his diaries get into: what he privately thought while he was publicly saying different things. Where to begin? The origins of the pandemic. Fauci has not only been a proponent that the only answer to where the virus came from is a natural spillover event. He's gone further than that. He orchestrated a paper published in Nature Medicine called "The Proximal Origin Paper," written by a bunch of people who bolstered that point of view. He, of course, edited that paper before it was published. Then in public, he pretended like he didn't know those people. It was an independent group that validated what he was saying, whereas, in many respects, he sort of puppeted that paper. The people who wrote that paper—Rand Paul has released their Slack channel messages—showing they don't really even believe what they were writing. I mean, their messages reveal considerable ambiguity about lab leak versus natural spillover event. So in terms of the origin, he also funded EcoHealth Alliance, of course, which had a subcontract to Wuhan. He had a huge role in the origins and sort of at least trying to frame the narrative, making lab leak—you couldn't even discuss it. You know, Facebook put a ban on even talking about the topic. All right, that's just one thing. Then masking, masking 2-year-olds. I mean, he played a huge role in that. Lockdowns, school closure. He said he didn't close any schools. In his own diary, he says, "I told Bill de Blasio, you need to close schools in New York City." At some point, the man's got to take ownership over the decisions he did make and advocated for. When DeSantis in Florida reopened schools in the spring of 2020, he went on every television show to say what a bad idea that was. Of course, now I think it's very clear. Many of us said so at the time. School reopening was always the right decision. You know, maybe it could have been closed for a week or two, but certainly not beyond that. Fauci kept it closed much longer. Vaccines. I think vaccines make a lot of sense. COVID vaccines for elderly people who had not yet had COVID. But do they need to be given to a 4-year-old, a 7-year-old, a 12-year-old, a 22-year-old who'd also already had COVID? This is where considerable ambiguity exists. But Fauci, the answer was clear: You need all the shots. You need the initial series. You need a yearly booster. It doesn't matter how young you are or how many times you've had COVID. Then, of course, Fauci was wrong about—I think he's wrong about almost every single pandemic policy he advanced. Some of his defenders say to me, "Well, at least he didn't tell people to drink bleach." And I said, "Well, is that the bar for a guy who's a doctor and a scientist?" I mean, of course, yeah, drinking bleach is not a good idea. But that's not the bar for an Anthony Fauci-level figure. He should be saying things that are correct, and if they're not correct, he should be collecting evidence to weigh in. He did none of that.

我认为 Fauci 犯过很多严重错误。最大的新闻故事大概是：主流媒体拒绝诚实评价他的遗产。疫情开始时他已近 80 岁。如果他在 75 岁左右功成身退，我会觉得他留下的遗产很出色。但他继续推、继续留、贯穿整场疫情，成了许多事情的门面。日记写到：他私下怎么想，公开却说另一套。从哪说起？疫情起源。Fauci 不仅主张病毒只能来自自然溢出，还更进一步，推动了发表在 Nature Medicine 上、由一群人写成的 Proximal Origin 论文来支撑这一观点。他当然在发表前编辑过那篇论文，公开场合却装作不认识那些人，好像是一个独立小组验证了他的说法；在许多方面，他其实是在操弄那篇论文。Rand Paul 公布了作者们的 Slack：他们自己也不完全相信自己写的东西，对实验室泄漏与自然溢出仍有很大犹豫。起源问题上，他还资助了 EcoHealth Alliance，后者又分包到武汉。他对起源叙事的塑造作用很大，以至于实验室泄漏一度连讨论都不被允许——Facebook 甚至禁止谈论这个话题。这只是一件事。然后是口罩、给两岁幼儿戴口罩，他角色很大；封锁、关校。他说自己没有关任何学校，自己日记里却写：「我告诉 Bill de Blasio，你必须关闭纽约市的学校。」人总得为自己做过、倡导过的决定负责。当 DeSantis 在 2020 年春让佛罗里达复课时，他上遍电视说那是坏主意。现在很清楚——当时我们也这么说——复课始终是正确决定。最多关一两周，当然不该更久；Fauci 却让关得久得多。疫苗：我认为 COVID 疫苗对尚未感染过的老年人很有道理。但已经感染过的 4 岁、7 岁、12 岁、22 岁还要不要打？这里有巨大模糊。Fauci 的答案却很清楚：都要打，初免系列要打，每年加强也要打，年龄和感染次数都不重要。我认为他推进的几乎每一项疫情政策都错了。有些捍卫者对我说：「至少他没让人喝漂白剂。」我说：「对一个医生和科学家，这就是标准吗？」当然喝漂白剂不好，但那不该是 Anthony Fauci 级别人物的及格线。他应该说正确的话；若不正确，就该收集证据再表态。这些他都没做。

Why do you think that there was such a large disconnect between his public and private thoughts on the virus throughout this? Just as someone whose job it is to communicate science to the public, why wasn't he communicating what he actually knew at the time? For instance, about the origins of the virus.

你觉得为什么他在病毒问题上的公开表述与私下想法差距这么大？作为本职就是向公众沟通科学的人，他为什么不沟通当时真正知道的事——比如起源？

In the case of the origins, I think he doesn't want to communicate, then or now, because he looks a little bit culpable. Is it 2011? He writes a Washington Post op-ed called—the title of the paper is "A Flu Virus Risk Worth Taking"—about why we ought to fund gain-of-function research, or research to manipulate the genomes of viruses to perhaps make them more transmissible or lethal, in an effort to get ahead of that and cure it. But that's a gamble. Is that a sound strategy? I think it's pretty clear to say that it has not led to any cures and may have led to one of the worst pandemics in the last 50 years. You know, so that was a bad idea. He's on record as saying that. He's on record as having funded the EcoHealth Alliance group in 2014, despite an Obama-era sort of prohibition on that funding, and he has a presidential pardon that extends so far back that it covers his potential funding of EcoHealth Alliance. So, boy, nobody would rather you think it comes from a natural origin than this guy. He's conflicted. That's the bottom line on that issue.

起源这件事上，我认为他当时和现在都不想沟通，因为他看起来有一点责任。大概是 2011 年，他在《华盛顿邮报》写过一篇题为「值得承担的流感病毒风险」的评论，论证为什么要资助功能获得研究——也就是操纵病毒基因组、可能让它们更易传播或更致命，以求抢在前面去治疗。但这是一场赌博。策略靠谱吗？很清楚：它没有带来任何治愈，却可能促成了过去 50 年最糟的一场大流行。所以那是坏主意，他有公开记录。他也有记录：在奥巴马时期相关限制背景下，仍于 2014 年资助 EcoHealth Alliance；他还有一份总统赦免，覆盖范围远到足以涵盖潜在资助 EcoHealth 的时期。所以，没有人比他更希望你相信自然起源。他有利益冲突。这就是这件事的底线。

This is why Rand Paul is pursuing this, because he seems to be wanting to uncover what the origins of the virus are, which somehow we still don't know. It's unclear if we ever will. Do you have any sense, based on what we know now, what's your inclination as to where this came from?

这正是 Rand Paul 追下去的原因：他想查清病毒起源，而我们至今仍不知道，也不清楚是否永远能知道。按现在已知信息，你倾向认为它从哪来？

So I use an analogy, and an analogy is you can look at biology or you can look at intelligence. So imagine somebody comes out of the kitchen and they say, "You know what? That waiter peed in the soup." You're going to say, as a biologist, "How can I prove he peed in the soup?" You can sample the soup. You can look for urine metabolites and cells from the bladder. And you could try to figure it out that way. Or you could interview three people in the kitchen who say, "I saw the guy pee in the soup." OK. And my point is that we have the Central Intelligence Agency, the Department of Energy, the FBI, and they have made an intelligence assessment that they believe it to be a lab leak. In Fauci's own diary, he says he was pulled into the SCIF, which is sort of a confidential room, and he was given information by the CIA where they intercepted some transmissions from China that make them sort of suspicious that it was, in fact, a lab leak incident. To me, I think the public may never have the full evidence, but I suspect that many intelligence people do, in fact, know the answer. And that answer is probably lab leak. Whether it's malicious or unintentional, I think people can wonder about that. Fauci's own diary admits that the Wuhan wet market, which he went on TV and said was the origin—in his own diary, he writes, at best, it was an amplifying event. He doesn't believe it to be the origin.

我用一个类比：你可以看生物学，也可以看情报。想象有人从厨房出来说：「那个服务员往汤里撒了尿。」作为生物学家，你会说：「我怎么证明？」你可以取样、找尿液代谢物和膀胱细胞。你也可以去问厨房里三个说「我看见他往汤里撒尿」的人。重点是：中央情报局、能源部、联邦调查局都做过情报评估，认为是实验室泄漏。Fauci 自己的日记写到，他被拉进 SCIF（保密房间），中情局向他通报截获的中方通讯，让他们怀疑确实是实验室泄漏。我认为公众或许永远看不到完整证据，但我怀疑许多情报人员其实知道答案，而那个答案大概就是实验室泄漏。是恶意还是意外，可以各自去想。Fauci 日记也承认：他上电视说的武汉海鲜市场，最多只是「放大事件」，他并不认为那是起源。

You mentioned this pardon that stretches back to 2014, this era when the funding was—when he was authorizing funding in contravention to current U.S. policy, which is we're not going to do gain-of-function research. Do you think he actually committed a crime?

你提到那份回溯到 2014 年的赦免——当时他在违反美国「不做功能获得研究」政策的情况下授权资助。你认为他确实犯了罪吗？

Yes. I mean, I think funding—I think the other thing about it is people will say, "Did that money go directly for this research?" The money went for viral genomic research at a Chinese institute, very similar to the sorts of things we would be worried about. I think that was a crime for which he's been pardoned. I think it's not just my assessment. That's what Joe Biden's autopen thought when he signed—or whoever signed the pardon—that he committed a crime. That's why he has a pardon that goes that far back. I think it was a crime. Now that he's been pardoned for it, I don't know what you can do about it.

是的。人们会问：「钱是不是直接用于这项研究？」钱用于一家中国机构的病毒基因组研究，正是我们会担心的那一类。我认为那是一项他已被赦免的罪行。这不只是我的判断——Joe Biden 的自动签名笔、或真正签字的人，在签署赦免时也按「他犯了罪」来处理，否则赦免不会回溯那么远。我认为那是犯罪。现在他已被赦免，我不知道你还能拿他怎样。

How do you think history will remember, or should remember, Anthony Fauci?

你觉得历史会、或应该怎样记住 Anthony Fauci？

I think very poorly. I think this is where the media is completely enraptured by the guy. Put aside the origin. This is a guy who went on TV and told you that you should make your 2-year-old wear a cloth mask. He told you, "Stand 6 feet apart." Later he says, "Oh, the 6 feet, we just made that number up." He told you you should lock down schools. He called Bill de Blasio in his own diary and told him to close schools. Later he says, "Who started this whole school closure thing?" He said you've got to get a shot, even if you've had COVID and even if you're 20 years old and living in a dorm, even if you had myocarditis. He actually told Rochelle Walensky in his diary to downplay the evidence… So let's go back to 2021. In 2021, we learned that even if you've been vaccinated, you can contract and spread the virus. I think initially we didn't think that to be true, but certainly by the summer, with different escape variants, we thought that to be true. The decision to mandate a vaccine was not until the fall of 2021, long after we knew vaccinated people could get the virus and spread the virus. The moment you knew they could get and spread the virus, it doesn't make sense to have a mandate. The whole prerequisite for a mandate is there's got to be enough benefit to a third party that it justifies taking away your autonomy about your body. But he knew that you couldn't justify the benefit if you can still spread it. But he writes in his own diary, "We can't have Rochelle Walensky telling people that fact because it will undermine DOJ's efforts for a mandate." So he knowingly is hiding scientific truths to facilitate a policy preference of a Democratic president with whom he aligns himself. And he does that over and over. Finally, if you've had and recovered from the COVID virus, we've never had any evidence that you need any additional shots. And yet he never made that an exemption. I think that's a very damning thing. So I can't think of a single policy he actually got right when he was running the federal health policy.

我认为会很糟糕。媒体完全被他迷住了。抛开起源不谈：这是一个上电视告诉你该让两岁孩子戴布口罩的人；他说「保持六英尺距离」，后来又说「六英尺是我们编出来的」；他说该关校，日记里还打电话让 de Blasio 关校，后来又问「这关校是谁搞出来的」；他说即使得过 COVID、即使你 20 岁住宿舍、即使得过心肌炎也要打针。他在日记里还让 Rochelle Walensky 淡化证据……回到 2021 年：那年夏天我们已经知道，接种后仍可感染并传播；最初我们不这么想，但到夏天、面对逃逸变异株时已经清楚。强制接种却拖到 2021 年秋——远在我们知道接种者仍可感染传播之后。一旦知道仍可传播，强制就不再说得通。强制的前提是：对第三方有足够收益，才足以剥夺你对自己身体的自主。但他知道，既然仍能传播，就无法正当化这份收益。日记里他却写：不能让 Rochelle Walensky 把这个事实告诉公众，否则会削弱司法部推动强制的努力。他明知在隐瞒科学事实，只为配合一位与自己政治立场一致的民主党总统的政策偏好，而且一再如此。最后：感染并康复后，我们从未有证据表明还需要额外针剂，他也从不把它列为豁免。我认为这非常致命。想不出他在主导联邦健康政策时真正做对过哪一项。

And you kind of rode in on this wave of anti-Fauciism, in a way. At the head of that would be someone like RFK Jr., who's the head of HHS. What was your big hope? We'll get into the specifics of what you were doing at the FDA, but what was your biggest hope as to what the kind of new version of public health might look like or changes that might be made?

某种意义上，你是乘着这波「反 Fauci」浪潮进来的。站在浪头的是 RFK Jr.，现在是 HHS 负责人。你当时最大的希望是什么？具体 FDA 工作稍后再说——你最希望新的公共健康长成什么样，或做出哪些改变？

Well, I had a very narrow mandate because I was just in charge of biologics at the FDA, and the hope continues, which is that public health could aspire to be honest, to use its powers proportionately and judiciously, to exercise humility. Public health is far from these things. Public health could actually aspire to be bipartisan. Public health does not. It's becoming an increasingly entrenched left-wing discipline run by left-wing ideologues, reaching even more and more absurd conclusions. So what public health can be and what it is are still light-years apart.

我的授权其实很窄，因为我只管 FDA 的生物制品。希望仍然是：公共健康应力求诚实，权力用得克制而审慎，并保持谦逊。公共健康离这些还很远。公共健康本可以追求跨党派，实际上却没有。它越来越成了由左翼意识形态主导的学科，结论越来越离谱。公共健康可以成为什么、它实际是什么，仍然差着光年。

So you don't think that has changed very much?

所以你不觉得变化很大？

Not much at all. No. I mean, I think changing an entrenched organization with tens of thousands of people is very difficult. There have been some changes. I suspect that there's sort of been a catalyst. The pandemic has been a catalyst. But I don't think a real reform is possible. I suspect it'll splinter into different sort of public health groups and senses of that.

几乎没有。要把一个有数万人的根深蒂固组织改掉，非常难。有过一些变化。我怀疑疫情成了一种催化剂。但我不认为真正的改革可能。我怀疑它会碎成不同的公共健康群体和不同的理解。

And your role was at CBER, which is the part of the FDA that oversees what they call biologics. So that would be things like vaccines or gene therapies. Vaccines obviously became an increasingly polarized and politicized issue during COVID. What was your goal going in there pertaining specifically to vaccines?

你的岗位在 CBER，也就是 FDA 监管所谓生物制品的部门，包括疫苗、基因疗法等。新冠期间疫苗显然越来越两极化和政治化。具体到疫苗，你进去时的目标是什么？

You know, people ask me, like, they say, "Vaccines save lives." I say, "Drugs save lives." Like, the right drug given to the right person at the right time is life-saving, but the wrong drug given to the wrong person at the wrong time can be harmful. Vaccines are the same way. You can't say anything about all vaccines, just like you can't say anything about Tylenol, aspirin, and Plavix all in the same breath. They're all very different drugs. And yet I think there is a mentality in the mainstream media that vaccines are perfect. They're always perfect. More of them is always better than less of them. There are no problems in the current system. They can never be questioned. And I think that dogma has to go away. But that dogma continues. I mean, you want a recent example? This miscarriage argument. Fauci, in his diary, he says, "Boy, you know, that COVID shot's very reactogenic. People get fevers and they feel terrible. Possible that it will increase the rate of miscarriage." Now I read people say, "We know for sure it doesn't." Really? You know for sure it doesn't? Well, that's the part where I call it into question. I'm happy to concede that the best available evidence excludes a very large risk of miscarriage. There are some people on the right who said it was an 80 percent risk of miscarriage. That's ridiculous. This is not even possible. 80 percent miscarriages, you'd see that from a mile away. It's not an 80 percent risk of a miscarriage. But neither do we know it's a 0 percent risk. And science has to be very careful to say what we do know and what we don't know. Pfizer was actually asked to do a randomized study of pregnant women. They were randomizing 4,000 pregnant women in the course of that randomized study to learn whether or not the vaccine is safe and effective and whether it causes birth defects or miscarriage. They're going to look at 4,000 women being randomized. During the course of that study, the American College of Obstetricians and Gynecologists said all women should just get it. And they stopped their study with 300-some women randomized, and the study is inconclusive. It was never run to conclusion. So I think we should be very careful to say we actually don't know about a very modest increased risk of miscarriage. Even to this day.

人们常说「疫苗拯救生命」。我说「药物拯救生命」。对的药给对的人在对的时间能救命；错的药给错的人在错的时间会害人。疫苗也一样。你不能对「所有疫苗」一概而论，就像不能把泰诺、阿司匹林和 Plavix 放在同一口气里说——它们是非常不同的药。但主流媒体有一种心态：疫苗是完美的，永远完美，越多越好，现行体系没有问题，永远不可质疑。这种教条必须去掉，但它仍在。要最近的例子？流产争论。Fauci 日记里写：「那针反应很强，人会发烧难受，有可能提高流产率。」现在有人说「我们确定不会」。真的确定？我就在这里起疑。我愿意承认现有最佳证据排除了「极大」流产风险。右翼有人说 80% 流产风险，那荒谬到不可能——80% 流产你会隔着一英里看见。不是 80%，但我们也不知道是 0%。科学必须非常小心地说清我们知道什么、不知道什么。辉瑞曾被要求做孕妇随机研究，计划随机约 4000 名孕妇，看疫苗是否安全有效、是否导致出生缺陷或流产。研究进行中，美国妇产科医师学会说所有孕妇都应接种，研究在随机约 300 多人时停下，从未跑完，结论不明。所以至今我们仍应非常小心：对「很小幅度增加的流产风险」，我们其实并不知道。

This dogma that you describe of, you can't criticize anything about vaccines—to the extent that it exists, I imagine it's because of the very strong anti-vaccine movement that's been prominent in American history, spearheaded by people like RFK Jr., who—people kind of jump to these extreme claims of vaccine harms, whether it's the 80 percent miscarriage rates, claims about autism, and so forth. How do you balance that? Like, how do you talk honestly about vaccines without feeding into irrational fears?

你描述的「不能批评疫苗任何一点」的教条——如果它存在，我想是因为美国历史上很强的反疫苗运动，像 RFK Jr. 这类人带头，人们很容易跳到极端伤害说法，比如 80% 流产、自闭症等等。你怎么平衡？怎样诚实谈疫苗，又不喂养非理性恐惧？

Yeah, that's a really good question. I think the only way to do it is to just be completely honest about it. There will always be someone on the internet who says something wrong. But the public health instrument, the professors of the world, the doctors of the world, you can't respond to that by lying in the other direction, to give false statements that are not true in the other direction. But that's what's happening. On every issue, I just think—hepatitis B at birth. You want to talk about that? This happened while I was there. Bobby Kennedy and others had the idea that in America, if a mother tests negative for hepatitis B, maybe that baby doesn't need the Hep B shot at birth and can wait up to two months to get the shot. So a rational person would look at that and say, "Boy, there are pros and cons to this." OK. If the mother's really negative, and we know how Hep B is transmitted, largely through bodily fluids and intravenous drug use and these kinds of things, there is still a small chance the baby will get Hep B in the first two months. But it's really small. I mean, let's be honest, it's going to be quite small. And is there a downside to delaying two months? Maybe you'll actually lose a few people. They won't come back and get follow-ups, so it'll be an additional loss. But what's the upside? Maybe the upside is you'll give people a little bit more control over their bodies and control over their children. They might feel a little better. We live in a time where people are sort of unsure about vaccines. So I think a fair narrative would be, like, there are pros and cons about this approach. On balance, the numbers here are very, very small. If they want to make this a provision that some people could delay two months if the mother tests negative, I think it's probably reasonable, you know? But that's not the way the narrative was, right? "Bobby Kennedy is going to kill people." And then they said things like, "Before the Hep B vaccine, 50,000 people died a year." OK, sure. That's true. But what does it have to do with his specific policy of shifting from zero to two months in a subset of women who test negative or low-risk? It's completely tangential.

很好的问题。唯一办法就是彻底诚实。网上永远有人说错话。但公共健康工具、全世界的教授和医生，不能用反向撒谎来回应，不能在另一边给出不真实的陈述。可现在就是这样。每个议题都如此——出生时乙肝疫苗，要谈吗？我在任时发生了。Bobby Kennedy 等人的想法是：在美国，如果母亲乙肝检测阴性，婴儿或许不必出生时立刻打乙肝针，可以等到两个月内再打。理性的人会说：这有利有弊。若母亲真阴性，我们知道乙肝主要通过体液、静脉吸毒等传播，婴儿两个月内仍有很小概率感染，但真的很小。推迟两个月有没有代价？也许会丢掉少数人，他们不回来随访。好处呢？也许让人对自己的身体和孩子多一点控制感，感觉好一点。我们处在人们对疫苗不太确定的时代。公平叙事应是：利弊都有，数字都很小。若允许阴性或低风险母亲子集把针从出生推迟到两个月，我认为大体合理。但叙事不是这样，对吧？「Bobby Kennedy 要杀人。」然后说「乙肝疫苗前每年死 5 万人」。没错，那是真的。但这和他「在阴性/低风险母亲子集里把 0 个月挪到 2 个月」的具体政策有什么关系？完全是旁枝。

They've overhauled the childhood vaccine schedule. What are your thoughts on that?

他们大改了儿童疫苗日程。你怎么看？

I think that it's—you know, people make a big deal about it, but I don't know—the executive order… I don't know how much it's actually going to do. I think we're going to see the endgame play out, which is the following: There are going to be different vaccine schedules. If you're in San Francisco, where we're sitting right now, you're going to get the full-court-press liberal vaccine schedule, and if you're in Texas, you're going to get the conservative vaccine schedule. And to me, it's going to create probably a variety of vaccine schedules. I have mixed feelings about that. I think that it's very likely you'll get errors in both directions. You'll have some people given too many vaccines you don't need, and there are some people omitting vaccines they do need. At the same time, the pro of this is that it does kind of shatter this idea that there's a one-size-fits-all federal government vaccine solution that can be deployed to 400 million people, and it's going to be perfect. I think it creates sort of different opportunities to think about it.

人们把它说得很夸张，但行政令实际能做多少，我不确定。我认为终局会是这样：会出现不同的疫苗日程。像我们现在坐着的旧金山，会是全面自由派日程；得州会是保守日程。会出现各种各样的日程。我心情复杂。很可能两边都会犯错——有人多打不需要的，有人漏打需要的。同时，好处是：它打碎了「一套联邦疫苗方案就能完美覆盖 4 亿人」的幻觉。它创造了不同的思考空间。

There have been a number of measles outbreaks. Do you attribute that to sort of either a loosening of vaccine policy or just a general skepticism, rising skepticism toward vaccines?

近来有不少麻疹暴发。你把它归因于疫苗政策放松，还是对疫苗普遍上升的怀疑？

I think it's difficult to attribute. People like to attribute it to what Bobby Kennedy has done, but surely, in order to have the outbreak now, people have to forgo measles vaccines in years prior. And it's also going on in Canada. So I don't know how he jumped across the border and did it. I mean, the truth is there is a growing distrust of establishment medicine. It was precipitated by the pandemic, and it probably is also precipitated by, you know, fringe anti-vaccine voices, and they've shattered confidence in the measles vaccines. And so, you know, there's lower uptake of the measles vaccines. There's going to be measles outbreaks. To blame it on one person doesn't make sense to me.

很难归因。人们喜欢归给 Bobby Kennedy 做了什么，但要出现今天的暴发，人们必须在更早年份就少打麻疹疫苗。加拿大也有类似情况——我不清楚他怎么跨过边境去干的。真相是：对建制医学的不信任在增长，由疫情催化，也可能由边缘反疫苗声音催化，他们打碎了对麻疹疫苗的信心，接种率下降，就会有麻疹暴发。怪一个人说不通。

I want to look at a specific example of a different way that you approach vaccines than your predecessors. Moderna came to the FDA with an application for an mRNA flu vaccine. You sent that back and said, "This is not good enough." What was wrong with that? This was like a billion-dollar study. So what was wrong with that study from your point of view?

我想看一个具体例子，说明你处理疫苗的方式和前任不同。Moderna 向 FDA 提交 mRNA 流感疫苗申请。你退回说「不够好」。哪里不对？那可是十亿美元级的研究。从你的角度看，研究错在哪？

Initially, the company asked for approval of the vaccine in anyone over the age of 50 and a regular approval, meaning there would be no further post-marketing efficacy commitment. That was what they asked because they did a randomized controlled trial of their new vaccine against an older vaccine in that age group. Now, we issued a refuse-to-file because, for at least 10 years, that's not the standard of care for people over the age of 65. If you go to the vaccine experts right now, they're going to say you need a high-dose or adjuvanted flu vaccine if you're elderly, because these vaccines have beaten this older vaccine for 10 years. We've known about it for 10 years. You go to a pharmacy here, you go ask these vaccine experts, they'll say, "This vaccine doesn't cut it if you are 66, 67." And yet they used that as the control arm of this study. This happens all the time in drug approval. The companies use a control arm that is not the best available American standard of care. In my opinion, that's unethical. The control arm participants are getting worse care than they would if they just walked into the MinuteClinic.

最初公司要求对 50 岁以上常规批准，且不再承担上市后疗效承诺。依据是新疫苗对该年龄组「较老疫苗」的随机对照。我们发出 refuse-to-file，因为至少十年里，这不是 65 岁以上的标准护理。你去问疫苗专家，他们会说老年人需要高剂量或佐剂流感疫苗——这些疫苗击败旧苗已有十年。走进药房、问专家，都会说：66、67 岁，这支旧苗不够。他们却用它当对照臂。药品审批里经常这样：公司用的不是美国最佳可用标准护理。我认为不道德。对照臂受试者得到的护理，比走进 MinuteClinic 还差。

So yeah, your view then is that for this to proceed, it needs to outperform the best vaccine on the market.

所以你的意思是：要继续推进，它必须胜过市面上最好的疫苗。

The statutory language is that in order to file, you need an adequate and well-controlled study, and it is not well-controlled on the plain-English meaning of it because it is not the best available standard of care in America. In fact, it subjects the control arm to higher risk. They're getting a vaccine that's not as good as what they would get if they go to CVS or Walgreens or see me in clinic. So it's not the best available care. So that is a refuse-to-file. Now then, we accepted a resubmission while I was there, but it split the application into two parts: a regular approval, 50 to 64, and an accelerated approval, 65 and up, which they ultimately got. People say that we've done a 180, but we've actually given a very different approval. They have a confirmatory efficacy study, 65 and up, and that study will answer the question whether or not their vaccine is as good or better or worse than the correct control arm.

法定语言是：要受理归档，需要充分且良好对照的研究。按普通英语含义，它并非良好对照，因为它不是美国最佳可用标准护理，反而让对照臂承担更高风险——他们得到的疫苗不如去 CVS、Walgreens 或来我诊所。所以是 refuse-to-file。后来我们在任内接受了再提交，但把申请拆成两部分：50–64 岁常规批准，65 岁以上加速批准（他们最终拿到了）。有人说我们 180 度转弯，其实给的是非常不同的批准。65 岁以上有确证疗效研究，会回答相对正确对照臂是更好、一样还是更差。

OK, so the fact that the FDA has approved it for certain populations since your departure, you're generally supportive of that decision.

所以你离任后 FDA 已批准部分人群使用，你大体支持这个决定。

I guess I'm generally supportive of the fact that it's better than what came in the door in the first place. I think there are open questions which people should ask, which is: Would you rather get the shot or the flu? You can go look at the rate of grade 3 adverse events in the clinical study and compare it against the actual rate of influenza seen in the study. So lots of questions that are—those are review questions. Those are questions about the review process. I wasn't part of it, so I don't know the file very deeply there. But the initial question was a question about what are they asking for, and is that something that's an acceptable thing to consider? And we changed that. I think that was the right call. I think the media coverage of that topic is terrible. I don't know a single media story that draws the distinction between the resubmission and splitting the age group and the original submission. I don't know a single media story that asks: The control arm of that study, what evidence is there for a 67-year-old? You pull the control arm, you pull the package leaflet, and you'll see there are no efficacy data. It's an immunobridging agent, so it's antibody titers for these older groups. It is a very flimsy control arm. The media want to portray it as, you know, "You're either pro-mRNA vaccines or you're against it." But again, like I say, it's just right drug, right place, right time, all wrong.

我大体支持的是：它比最初进门的申请更好。仍有开放问题该问：你更愿打针还是得流感？可以看临床研究里 3 级不良事件率，对比研究里实际流感发病率。这些是审评问题，我不在那次审评里，对案卷没有那么深。但最初的问题是：他们在要什么、那是否可接受？我们改了这一点，我认为做对了。媒体报道很糟。我没见过一篇把「按年龄拆分的再提交」和「原提交」区分开的报道；也没见过一篇问：67 岁对照臂有什么证据？你把对照臂、把说明书拉出来看——没有疗效数据，是免疫桥接、抗体滴度，对照臂非常薄弱。媒体想把它画成「你要么挺 mRNA 疫苗，要么反对」。但再说一次：就是对的药、对的地方、对的时间——或全错。

So this is the same—in your view, this is the same phenomenon that we observed during COVID, where you're either for the vaccine or you're against it. You're either for this medicine or against it, and not sort of breaking it down by what age are you, how healthy are you, and so forth. Everything kind of has to be flattened or compressed.

所以在你看来，这和新冠时一样：你要么挺疫苗要么反疫苗，要么挺这药要么反这药，而不是按年龄、健康状况拆开。一切都被压扁、压缩。

One-size-fits-all public health, where the shoe doesn't fit the guy with the big foot or the person with the small foot. I mean, it's just completely—a completely wrong view of public health. And COVID is a great example. An 80-year-old who's never had COVID, who, you know—and we're talking about February of 2021—should they get a vaccine? Absolutely. A 7-year-old who's had COVID, and we're talking about 2022? No. That makes no—the healthy 7-year-old makes no sense. So public health is, in this country, so broken, it cannot appreciate these distinctions. And I think the Moderna flu is another one. One more point: Why do some people like the Moderna flu, despite the limits of it? They think the mRNA platform can change quicker than the older egg-based production platforms. That's a hypothesis you can actually test. You could run a study in a season where you compare the flu shot as it's conventionally manufactured against an mRNA flu shot that's made closer to the date of deployment. Presumably, by being closer, they can pick the antigens better than by starting production earlier. We could ask that question, but there is no appetite for asking that question. People assume the very thing they set out to prove, which is it must be better because it can be adapted quicker, rather than testing that formally.

一刀切公共健康：大脚穿不上，小脚也不合适。这是完全错误的公共健康观。新冠是绝佳例子。一个从未感染过的 80 岁老人，在 2021 年 2 月，该不该打疫苗？绝对该。一个已经感染过的健康 7 岁孩，在 2022 年？不该。说不通。这个国家的公共健康太破碎了，欣赏不了这些区分。Moderna 流感是又一例。再补一点：为什么有人尽管有局限仍喜欢 Moderna 流感？他们觉得 mRNA 平台比蛋基生产改得更快。这是可以正式检验的假说。你可以在同一季比较传统制造的流感针，和更接近部署日期制成的 mRNA 流感针——理论上更晚锁定抗原会更好。我们可以问这个问题，但没人有胃口去问。人们假定了他们本该去证明的事：因为它改得更快所以一定更好，而不是正式去测。

So yeah, this has been something you've been writing about for a long time, is the poor experimental design for drugs. And I assume that's something that you wanted to change when you came into FDA. Do you feel like you made any progress toward that goal?

这是你写了很久的主题：药品实验设计很差。我猜你进 FDA 也想改这个。你觉得朝这个目标推进了吗？

I mean, I think in one year, we did more than, you know, what our predecessors have done in a decade. You can look at just the sheer number of announcements and policy changes we've made. And we're talking a lot about one side of the coin, which is where the companies are not doing the right study to inform the American public. We're not talking about the other side of the coin, where FDA is asking them to do things that don't make any sense at all, that burden them, that cost money, and that are wasteful. We did a lot of work in that space too. And so I think FDA makes both errors. I mean, of course, they also do a lot of things right. But they make both errors, and they can get better. And I guess I'm glad we did some of the things we did to change it.

一年里我们做的，超过前任十年。光看我们发布的声明和政策变化数量就知道。我们谈了很多硬币的一面：公司没做能真正告知美国公众的正确研究。另一面是：FDA 要求他们做完全说不通、加重负担、烧钱又浪费的事。那一面我们也做了很多。FDA 两种错都会犯——当然也做对很多事——但可以更好。我高兴我们做了其中一些改变。

A memo leaked during your tenure. It was from you informing your staff that FDA's vaccine safety evaluators have discovered at least 10 children have died after and because of receiving COVID-19 vaccination, and that the real number is higher. You wrote that a public report would be forthcoming, marking the first time that the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children. Five months later, there's no report and you were gone, and an FDA official report then came out a month after you left saying that zero childhood deaths were definitively linked to the vaccine. So what actually happened there?

你任内一份备忘录泄露。你告知员工：FDA 疫苗安全评估人员发现至少 10 名儿童在接种 COVID-19 疫苗后、并因疫苗死亡，真实数字更高。你写将有公开报告，这将是美国 FDA 首次承认 COVID-19 疫苗导致美国儿童死亡。五个月后没有报告，你已离开；离任约一个月后一份官方报告说，零例儿童死亡与疫苗「确定关联」。到底发生了什么？

Yeah, that's—that's the reading of that. OK. Well, I would say that that's part of that report. Ron Johnson got part of it. "Certainly linked." OK, so when we talk about attribution of what's the cause of death, there is certain, there's likely, there's probable, there's possible, there's uncertain. You know, the standard for certain is unattainable. Ok? You need to—for instance, if you give the MMR vaccine to kids, occasionally they get a granuloma, and you can biopsy it and you can find vaccine product in the granulomas. If you give the chikungunya vaccine and somebody dies from it, you can sample the CSF and you'll find the vaccine strain chikungunya in there. You're not going to find that with myocarditis. OK, but absolutely, is it the case that kids died of myocarditis from the COVID-19 vaccine? Yes, absolutely, it is the case. And just because the death isn't coded as certain and is coded as probable or possible, that doesn't negate the fact that it is attributable. In fact, the standard across all of drug development is possible and probable are attributable, I would say—

那是一种读法。我会说那是报告的一部分。Ron Johnson 拿到了部分。「确定关联」。谈到死亡归因，有确定、likely、很可能、可能、不确定。「确定」的标准几乎达不到。比如 MMR 偶尔导致肉芽肿，活检能找到疫苗产物；基孔肯雅疫苗若致人死亡，脑脊液能找到疫苗株。心肌炎找不到这种东西。但儿童是否因 COVID-19 疫苗心肌炎死亡？绝对有。死亡没被编码成「确定」而被编成「很可能」或「可能」，并不否定可归因。事实上，整个药物研发惯例里，「可能」和「很可能」通常都计为可归因——

Just to be very specific about that, then, yeah, it said there were zero childhood deaths definitively linked to the vaccine. Five deaths were classified as possible and two as probable. So that's still less than the 10 that originally—

说得非常具体：报告写零例儿童死亡与疫苗确定关联；5 例「可能」，2 例「很可能」。这仍少于原先的 10——

They changed the report. I had a draft report with 10. They changed it after the media publicity of my letter.

他们改了报告。我有一份含 10 例的草稿。媒体曝光我的信之后，他们改了。

Who changed it?

谁改的？

The people who did the report, the people who said that they had been looking into this issue for years. Let's make a few points. OK, I want to back up. I want to make one point.

做报告的人，那些说自己查这个问题已经很多年的人。我先退一步，讲几点。

Yeah.

好。

If a million people trip on one stair, what's going to happen? A million people fall down just one stair. 999,000 just walk it off. A thousand people twist an ankle. Maybe 10 people fall and get a gash on the forehead. But one person is going to die. Just a million people fall off one stair, somebody's going to die, right? That's just the law of big numbers. Myocarditis is a known side effect of mRNA COVID-19 vaccines, occurring at a frequency as high as one in 3,000, per the original Israeli report. And you're getting lots and lots of people to have it. We know that some of those people can actually get scarring of the heart. Some people require pressor support. They go into the ICU. Somebody's going to die. In fact, there are many case reports published globally. You can just look in the published literature of people who've died globally from this. There's a South Korean study that shows something like 20 deaths. So, of course, if the answer was zero people died of COVID-19 vaccine-related myocarditis, that would be the controversial outcome. OK? So the media somehow want to defend the idea that zero people die. That's preposterous. Somebody's got to die. So what happened was they say they adjudicate all the deaths that come in in the VAERS system. This is a passively reported system. So a lot of people may have gotten the shot and died, but nobody decided to report it to the FDA. Or they started the report process, they never completed it. We have data that most people who start the process don't complete it. Of the reports that get completed, they get sent to the FDA, and then they start to look into them. A contractor's supposed to pull the autopsy reports, but this contractor sometimes doesn't pull the autopsy. So we don't have autopsy reports on some of these deaths, which make it difficult to adjudicate and make them unlikely to say even possible for those deaths. So this is the process. Tracy Beth Høeg, who was the CDER acting chief, she started to investigate these deaths. She thought she found some that were really kind of telling. Kid gets the vaccine and then is found dead with a heart with lymphocytes infiltrating, looks like myocarditis, rather plausible. The staff that's worked there for years are very concerned. It undermines what they're supposed to have been doing all these years, surely, because if you're supposed to be looking at safety and you never found it, now somebody new comes along and says, "You've got this problem," you're also, just like Fauci, a bit conflicted about whether or not you're the best person to investigate. But having said that, I still tasked them with looking into it. They sent me a report with 10 deaths: possibles, probables, and likelies. And I wrote my memo saying that a lot has to change because how come this is the first time where we're talking about it? They downgraded the memo to seven. The point still stands. Seven or 10, the vast majority of these deaths are probably not even reported into the system. It's a passive collection system. And I'm surprised it's provocative. It shouldn't be provocative that a vaccine with a known side effect of myocarditis—and myocarditis is bad, it can be very bad—that it would kill somebody. That's got to be not that—it would be more implausible that it killed zero people.

如果一百万人绊一阶楼梯会怎样？99.9 万人拍拍就走，一千人扭伤脚踝，也许十人额头裂口，但会有一个人死掉。大数法则如此。心肌炎是 mRNA COVID-19 疫苗的已知副作用，以色列最初报告频率可高达约 1/3000，大量人会发生。我们知道有人会心脏瘢痕，有人需要升压药、进 ICU，就会有人死。全球有许多病例报告，韩国研究显示大约 20 例死亡。所以如果结论是「COVID-19 疫苗相关心肌炎死亡为零」，那才是有争议的结果。媒体却想捍卫「零人死亡」，荒谬。总会有人死。他们说会裁决 VAERS 里所有死亡。这是被动报告系统：很多人可能接种后死亡却无人向 FDA 报告；或开始报告却没完成——多数人开了头完不成。完成的报告送到 FDA 再查。承包商本应调尸检，有时却调不到，没有尸检就更难裁决，甚至难说「可能」。Tracy Beth Høeg（当时 CDER 代理负责人）开始查这些死亡，觉得有些很能说明问题：孩子打完针后死亡，心脏有淋巴细胞浸润，像心肌炎，相当说得通。在那里干了多年的员工很紧张——这动摇了他们这些年本该做的事：如果你本该盯安全却从未发现，现在新人说「你有这个问题」，你也会像 Fauci 一样，对「自己是否最适合调查」有利益冲突。即便如此，我仍让他们去查。他们给我一份 10 例死亡的报告：可能、很可能、likely。我写备忘录说很多东西必须改——为什么现在才第一次谈？他们把备忘录降到 7 例。要点仍在：7 还是 10，绝大多数死亡大概根本没进系统。这是被动收集。已知副作用是心肌炎——心肌炎可以很严重——却说它不该杀任何人，才更离谱。

Do you believe the memo was downgraded for a political reason?

你认为备忘录被降级是出于政治原因吗？

Political or professional reasons, that nobody wants to look like, you know, this problem is as bad.

政治或职业原因——没人想让问题看起来那么严重。

Do you know who leaked the memo?

你知道是谁泄露了备忘录吗？

Who leaked the—Ron Johnson posted the memo. Like, it's not leaked. Ron Johnson has subpoena power, so Ron Johnson got the memo, and he has the final memo. There's an additional memo looking at another age group. Ron Johnson hasn't subpoenaed that. Maybe he doesn't even know that exists. But there's a few more deaths in that one. There's three more deaths in that one, so it'll be something like 10 deaths.

谁泄露——Ron Johnson 把备忘录公开了。不算泄露。他有传票权，拿到了备忘录，也有最终版。还有另一份看其他年龄组的备忘录，他没传票那份，或许甚至不知道存在。那份里还有几例死亡，大约再加 3 例，合计仍大约 10 例。

So what should the public take away from this information, given that even if this higher estimate is accurate, that's sad, but it's not a lot. And even COVID can kill children, even though that's also very rare. So what should people make of all that?

即便较高估计准确，也很令人难过，但数字并不大；COVID 也可能杀死儿童，尽管同样罕见。公众该从这些信息带走什么？

I think people should make of it: It was a really bad idea to vaccinate healthy kids for COVID and force them to do it, especially college kids. There are, on average—college kids did, in fact, probably were harmed on average by that policy, and we published on that before I got to the FDA. I think public health has to take ownership of the fact that the one-size-fits-all COVID-19 policy and boosters was a bad thing for young people. It did damage. They won't—mean, if you can't admit what you got wrong, you know… So I don't know what to take away from it. I think that it's disappointing that—why, I guess, to me what's disappointing is that there are people who say incorrect things about vaccines, that they have microchips, OK, or whatever, all sorts of crazy things. I hear a million crazy things, OK? They're crazy people. So is the response to that to lie about the real safety concern? I don't think that makes sense. Just be honest about it, and then maybe don't mandate it in 20-year-old boys who are going to dorms, who just had COVID. Why do they do that? That's a Fauci policy. That makes no sense, you know? Like, so just admit we got that one wrong.

我认为该带走的是：给健康儿童打 COVID 疫苗并强制他们打，尤其是大学生，是非常坏的主意。平均而言，大学生群体很可能被该政策伤害——我进 FDA 前就发过相关文章。公共健康必须承认：一刀切的 COVID-19 政策与加强针，对年轻人是坏事，造成了损害。如果你不能承认自己错在哪……所以我不知道还能带走什么。让我失望的是：有人说疫苗里有芯片之类的胡话，我听过一百万种疯话。他们是疯子。对此的回应难道是对真实安全问题撒谎？说不通。诚实说出来，然后也许别对刚得过 COVID、要住宿舍的 20 岁男生强制接种。为什么要那样做？那是 Fauci 政策，说不通。承认那一项我们错了就好。

You clearly came in wanting to raise the bar for vaccine and gene therapy approvals. Was there tension with the Trump administration's deregulatory impulses, the desire to make it easier to access certain kinds of drugs?

你显然想抬高疫苗和基因疗法的审批门槛。这和特朗普政府的放松管制冲动——想让某些药更容易获得——有没有张力？

I guess one thing I want to point out about "Right to Try", which is Trump's signature policy, is it's right to try, but it's not mandate to pay. You know, it's a big difference. Right to try means you should have the ability to try an investigational agent given to you either for free or at the manufacturing price. It doesn't say given to you for $4 million a pop and force Medicare to pay. And that's just what the bill says. The next thing I'd say is I would draw a distinction between vaccine policy and gene therapy and rare diseases. In many ways, we were quite permissive with rare diseases. We created a pathway where you can approve a product that's individually made for babies with, say, enzymatic process deficiencies, the plausible mechanism pathway. We debuted that sort of pathway. That's a lot of flexibility. That's flexibility that didn't exist before. For kids who are suffering from, like, incurable and rare diseases, I think we did do a lot of flexible things. We didn't demand randomized studies. We gave full approval for uncontrolled studies. The vaccines are a different thing. We're not talking about people who—there are some vaccines used only for people with rare diseases, but most of them are this one-size-fits-all for every healthy kid. And in that case, I think people in America want to know that they're safe and effective, including the president. You can see, reading between the lines of his executive order, he has a lot of concerns and doubts. He may not place them in exactly the right places, but he does have those concerns or doubts. And so in the vaccine space, I do think the bar should be brought up higher. I think it is kept low for political reasons. It is the political preference of the left to have to just say every vaccine is great and to not acknowledge that there are some serious downsides and concerns to some vaccine products. To not talk about—like, that Hep B debate, I think, was a great example. I mean, the coverage was that if you give an inch on Hep B at birth for mothers who test negative—and, by the way, there are new, some ultrasensitive antigen testing, so they're pretty confident they're negative—you're going to have an epidemic of liver failure as a result. And that's, come on, that's just not plausible.

先说特朗普标志性的「Right to Try」：有权尝试，不等于强制买单。有权尝试意味着你应能免费或以制造成本获得试验性药物；不是以每次 400 万美元给你、并强迫医保买单。法案就是这么写的。其次，疫苗政策与基因疗法、罕见病要分开。在许多方面，我们对罕见病相当宽松：为有酶缺陷等、可个性化制造的产品开了通路，即「合理机制通路」。那是以前没有的灵活性。对患不可治愈罕见病的孩子，我们做了很多灵活事：不要求随机对照，对非对照研究也给充分批准。疫苗是另一回事。少数疫苗只用于罕见病，但多数是面向每个健康儿童的一刀切产品。那种情况下，美国人——包括总统——想知道它们安全有效。你读他行政令的字里行间，会看到很多关切和怀疑；位置未必完全对，但关切在。所以疫苗领域门槛应抬高。我认为它因政治原因被压低：左翼的政治偏好是「凡疫苗皆好」，不愿承认某些产品有严重副作用与关切。出生时乙肝那场辩论就是例子——报道说：只要在阴性母亲上松一寸（顺便说，现在有更灵敏抗原检测，阴性更有把握），就会出现肝衰竭大流行。拜托，那根本说不通。

How did working at the FDA affect your own confidence as a consumer in the regulatory system?

在 FDA 工作，如何影响你作为消费者对监管体系的信心？

I guess it gives me a little bit of pause sometimes. I like to trust but verify. I particularly am cautious always with new therapies and particularly cautious that some safety information is being missed. And I think it also makes me a bit more libertarian. I can imagine a system where we give people in America greater flexibility in what kind of products they can try. And maybe there are some third-party agencies, like Consumer Reports–style agencies, that give different levels of quality and seals of approval of different products. And people can choose what they want and maybe also have a little bit more skin in the game and use their own money. And then the moment you start to use your own money, suddenly tiny changes in surrogate biomarkers and elevated liver enzymes take on greater importance in a way that might not exist if you're using commercial insurance to pay for it.

有时会让我多一点停顿。我喜欢信任但核实。对新疗法尤其谨慎，也特别担心有些安全信息被漏掉。它也让我更自由意志主义一点。我能想象一个系统：美国人在可尝试的产品上有更大弹性；或许有像《消费者报告》那样的第三方机构，给不同产品不同质量与认证印记；人们自己选，也多一点「皮肤在局内」、用自己的钱。一旦用自己的钱，替代生物标志物的微小变化、肝酶升高，就会比用商业保险付钱时重要得多。

Is it just you saw something inherent to the process that creates problems or holes or gaps?

是你看到了流程里固有的问题、漏洞或缺口吗？

I guess that the fundamental idea that there's this one-size-fits-all balance where safety and efficacy is acceptable. I mean, what might be acceptable to you and acceptable to me might be different. I might want a little bit more efficacy information, a little more safety validation, and you might be willing to try more. And the idea that a single monolithic government agency in the suburbs of D.C. can set that bar for every single person in America, that, to me, is a tougher pill to swallow now.

根本想法是：存在一套对所有人都可接受的安全—疗效平衡。对你可接受的，对我未必一样。我可能想要更多疗效信息、更多安全验证，你也许更愿尝试。华盛顿郊区一个单一政府机构，能为美国每一个人设定那条杠——这一点，我现在更难吞下去。

You mentioned there were two sides of this FDA reform. One was to raise the standards for things like vaccines. The other was acknowledging that, yeah, it's very expensive and cumbersome to get anything approved in the United States. What were the biggest barriers that you saw in the FDA from that side of the equation?

你提到 FDA 改革有两面：一面抬高疫苗等标准；另一面承认在美国获批任何东西都很贵、很繁琐。从那一面看，你见到的最大障碍是什么？

Well, so many. I think I would say that during my time at the FDA, I was often sympathetic to the people who work at companies who told me about sort of the hurdles they were forced to jump through. And to me, a big set of hurdles are if, you know, FDA does two things. We regulate what's approved and can be marketed and sold on the U.S. market, but also what you can study. And imagine you're a researcher and you want to study something. We're not talking about approve it. You want to gather people together who may be interested in trying something new, have an informed consent, get them to volunteer, but they know that, you know, we don't know for sure it's going to work. We do so many things in that space, regulating what you can study and how you can study it, that I think are sensible. Sure, you don't want to let people sign up for something that's going to blind them or maim them. But some things aren't sensible, that are overly burdensome, that are quality controls that don't make sense for small companies and super-rare diseases that don't have a huge budget to study these things. So I think the regulation in this early side of research is tremendous in the United States. A lot of it well-intentioned, but not all of it fit for purpose.

太多了。任内我常同情公司的人告诉我他们被迫跳的障碍。FDA 做两件事：监管什么可批准、可在美国市场销售；也监管你能研究什么。想象你是研究者，只想研究某样东西——不是批准——召集可能感兴趣的人，知情同意、自愿参与，他们也知道未必有效。我们在「能研究什么、怎么研究」上做了太多规定。有些合理：你不想让人报名去做会致盲或致残的事。有些不合理：对小公司和超罕见病过度负担，他们没有大预算去做那些质量控制。美国早期研究端的监管极重，很多出于好意，但并非全都适合目的。

There was a deregulatory impulse there. Makary talked about wanting to make more things over the counter.

那里有放松管制冲动。Makary 谈过想让更多东西变为非处方。

And that still should happen.

那仍应该发生。

RFK Jr. has pushed to make testosterone and peptides and so forth more available and accessible while being more skeptical of pharma more broadly. Yeah, you said you're supportive of those sorts of ideas, making—

RFK Jr. 推动让睾酮、多肽等更易获得，同时对药厂更怀疑。你说你支持这类想法——

Some of those ideas.

其中一些想法。

Well, OK, so making over-the-counter medication…

好，那非处方药……

I think simvastatin is a great example. Do you really need to talk to a doctor about a statin these days? You can go get a calculator, and you can decide if you want to take a statin yourself. It's a great example of something that could be over the counter. There are so many drugs where the doctor or the MinuteClinic or these services, they're just a gatekeeper from consumers having access to these products. The peptides, I think, are sort of a mixed bag. There are some peptides that I think have very limited efficacy. There are others that have maybe more efficacy. And some of that battle is not really about safety or efficacy; it's about profitability. You see right now that—maybe I shouldn't say the exact peptide—but there's one peptide that a lot of people are using. They're getting it through these compounding pharmacies, and the manufacturer that holds a patent on that, they do not like that. They're going to lose a lot of money, and so they want to kind of fight that off. So, like so many things, there's nuance there. There are some peptides that probably would be good for consumers to have a little bit more flexibility in getting through a compounding pharmacy, but not all.

我认为辛伐他汀是好例子。现在谈他汀还真需要找医生吗？你可以拿计算器，自己决定要不要吃。很多药上，医生或 MinuteClinic 之类只是消费者获取产品的看门人。多肽我认为好坏参半：有的疗效很有限，有的可能更强。有些斗争其实不是安全疗效，而是利润。现在有一种很多人用的多肽，通过复配药房拿，持有专利的厂家不喜欢——会亏很多钱，所以要打压。像很多事一样，有细微差别。有些多肽大概适合让消费者通过复配药房多一点弹性，但不是全部。

Did you ever feel, sort of, that you were pushing against that? That if there was a deregulatory impulse, but you, in a sense, wanted to make things stricter in certain domains, did you feel a tension working within that system?

你有没有感觉自己在顶着那股力？一边有放松管制冲动，你却想在某些领域更严——在体系里工作时有张力吗？

I guess I'm always a case-by-case person. So I'm always—you want to talk to me about a specific drug product, specific application, I'll get to the bottom of it, and I'll give you a presentation. And what I found was that, to the credit of Robert F. Kennedy Jr., he listens to when you make the case, you know? And sometimes I make the case to him that wasn't his initial instinct. But I often think that the way the media do a disservice to him is they say his instinct is always wrong. One of his instincts is that, you know, for-profit companies sometimes manipulate data to get people to use something to make a lot of money. There's a kernel of truth in that instinct, isn't there? And, you know, there's a kernel of truth in that instinct. So take that kernel and think about where it applies, but also think about where it doesn't apply, because for-profit companies also make a lot of terrific products that do good. And that's what I tried to do.

我总是个案处理。你想谈具体产品、具体申请，我会挖到底，给你做陈述。我发现——要给 Robert F. Kennedy Jr. 记一功——他会听你把案卷讲清楚。有时我讲的和他最初直觉不同。媒体对他不公之处在于说「他的直觉永远错」。他有一个直觉：营利公司有时会操纵数据，让人用某样东西好赚大钱。这个直觉里有真实内核，对吧？把内核拿出来，看哪里适用、哪里不适用——因为营利公司也做出很多真正有益的好产品。这就是我试图做的。

Well, yeah, I wanted to ask about a specific example that was one of the more controversial flash points in your tenure there, which was The Wall Street Journal ran a scathing op-ed whose writer called you a "one-man death panel" because you pushed—you pulled access to some of these experimental treatments, including a gene therapy for a form of muscular dystrophy, following some patient deaths.

我想问你任内更有争议的一个冲突点：《华尔街日报》发了严厉评论，作者称你是「一人死亡委员会」，因为你推动——你收紧了一些实验性治疗的可及性，包括一种肌营养不良基因疗法，在出现患者死亡之后。

Following people dying of it. Yeah, we did restrict that, yeah.

在有人因此死亡之后。是的，我们确实收紧了。

The point that that writer was making is that, again, these are people who have a terminal illness. They want access to this drug, and you, Vinay Prasad, are gatekeeping it from them. What's your response to that?

作者的论点是：这些人有终末期疾病，想获得这药，而你 Vinay Prasad 在把关挡住他们。你怎么回应？

Oh my goodness. I guess I'd say nothing could be further from the truth. That drug remains on the market, and anyone can get it for an off-label use. They want the indication so they can force the insurance company to pay the multimillion dollars for it, or whatever it costs. Certainly, I have a few thoughts. One is the editorial board of The Wall Street Journal, they know nothing about medicine. OK so they make mistakes in both directions too. They want things approved that are harmful and toxic and don't work, and they're missing things that are reforms that actually would help the businesses. So I think The Wall Street Journal editorial board, they're making the same two kinds of mistakes. I think you're alluding to the first time I left the agency in the summer of 2025. I mean, you have a drug product that came to the U.S. market where there's only one person I'm aware of at the FDA who wanted that product on the U.S. market. And that was the person who filed an override memo to approve it against the wishes of all the staff below. Hundreds and hundreds of people with expertise in the disease don't want to approve it because they think it doesn't work and has harms. But one person at the top thinks it does work.

天哪。再没有比这更远的了。那药仍在市，任何人都可以超适应症使用。他们要的是适应症，好强迫保险公司支付数百万美元。我有几点想法。一是《华尔街日报》社论委员会对医学一无所知，两个方向都会错：想批准有害、有毒、无效的东西，也漏掉真正能帮企业的改革。所以他们也犯同样两类错误。你大概在暗示我 2025 年夏第一次离开机构。有一种产品进入美国市场时，我知道 FDA 里只有一个人想让它上市——那个人写了 override memo，违背下面所有员工意愿去批准。成百上千有疾病专长的人不要批准，因为他们认为它无效且有害；顶上一个人认为它有效。

Who was that?

那是谁？

That was Peter Marks. That was a Peter Marks override memo on that product. So, famously, blundered everything about the COVID boosters too. OK, so—but I'm happy to let sleeping dogs lie. I mean, it's been approved, but I can't go back and revisit every decision. But then you get deaths. You get people who are getting the product who are dying. Well, what should the agency do about that? A product that has documented memos from review staff believing that they don't think it's helping. And now you have people dying. I think if you're going to say, "What's the purpose of the FDA?" And, you know, many libertarians might think, "We don't need an FDA." And I'm actually—

Peter Marks。那是 Peter Marks 对该产品的 override memo。他在 COVID 加强针上也臭名昭著地搞砸了。不过我愿意让过去的过去——它已获批，我不能回头重审每一个决定。但后来出现死亡，用药的人在死。机构该怎么办？审评人员有书面备忘录认为它不帮忙，现在又有人死。如果你问「FDA 存在的目的是什么」——许多自由意志主义者或许觉得「我们不需要 FDA」。我其实——

We're going to get to that.

我们马上会谈到。

OK, well, I'm kind of sympathetic a little bit.

好，我其实有一点同情。

I have it right here.

材料就在这儿。

I'm like, I can see your point. So I can see that point of view, and I appreciate that point of view. But if it's going to do anything, surely the one thing it's got to do is prevent people from taking something that you don't think helps at all and that can kill them. If it's going to do anything, surely it's got to do that. And so I think that that's a very reasonable change to the label that occurred in that case, where it was a group of patients—and there's a group of people that are younger, with lower body weight, who are walking, and the drug remains on the market for those people. And there's an older group of people with higher body weight—the drug is dosed based on body weight—that aren't walking, and that's where the deaths occurred. And it no longer remains on the market for that group of people. But they could still get it off-label, technically.

我能理解你的观点，也欣赏那个观点。但如果 FDA 要做任何事，它至少得阻止人们服用你认为完全没有帮助、却可能杀死他们的东西。如果它要做任何事，总得做这个。所以我认为那次标签变更非常合理：有一组更年轻、体重更低、还能行走的患者，药仍对那组保留；有一组更年长、体重更高——剂量按体重——且不能行走，死亡发生在那里，药不再对该组保留。但技术上他们仍可超适应症获得。

Part of the backlash to that—and this was the moment that precipitated your first departure from the agency—was Laura Loomer, the MAGA influencer, was blasting you on social media. She called you a "progressive left saboteur of the MAGA agenda." You didn't respond to Loomer at the time, but for understandable reasons, now that you're out, are you a far-left MAGA saboteur?

反弹的一部分——也是促成你第一次离开的时刻——是 MAGA 网红 Laura Loomer 在社交媒体上猛批你，称你是「破坏 MAGA 议程的进步左翼破坏者」。你当时没回应 Loomer，但现在你出来了，可以理解——你是极左的 MAGA 破坏者吗？

MAGA saboteur or MAHA saboteur? I think in many ways, I would say, I don't know if I'm a MAGA proponent or saboteur, but MAHA—I think the idea that, to Make America Healthy Again, I think there are lots of kernels of truth in that. There are lots of things that Bobby Kennedy is right about in the food supply, dyes in food, pesticides, toxins, and drug reforms, and vaccine reform. I think that there's lots of kernels of truth in that movement, and health care is kind of my predominant thing. Laura Loomer is a new type of lobbyist, but I think people shouldn't forget that we've always had lobbyists. There are lobbyists at the FDA for decades and decades. They don't always come across as a Laura Loomer, but they're there, and they have influence. So anyone who thinks it's a system that cannot be lobbied—I hear some people say, like, Laura Loomer is the first to lobby. She's not the first. She won't be the last.

MAGA 破坏者还是 MAHA 破坏者？在许多方面，我不知道自己是 MAGA 支持者还是破坏者；但 MAHA——让美国再次健康——我认为有很多真实内核。Bobby Kennedy 在食品供应链、食品色素、农药、毒素、药品改革和疫苗改革上，有很多说对的地方。这个运动有很多内核，而医疗健康大致是我的主线。Laura Loomer 是一种新型说客，但人们不该忘记：我们一直有说客。FDA 几十年都有说客，不一定长成 Laura Loomer 的样子，但他们在，也有影响力。谁以为这是不能被游说的体系——有人说 Laura Loomer 是第一个游说的，她不是第一个，也不会是最后一个。

To be clear, is this what caused you to be pushed out the first time?

说清楚：这是导致你第一次被推出去的原因吗？

It was interesting timing. I can leave it at that.

时间点很有意思。我就说到这儿。

OK. You know, you said that your time within the FDA made you somewhat skeptical or maybe more sympathetic to the libertarian critiques of FDA. What about that experience?

你说 FDA 经历让你对自由意志主义批评更怀疑，或许也更同情。那次经历怎样？

I guess I'm really sympathetic in one way, which is, like, the core sympathy is the following: We tax people a lot of money to pay for health care in America. I mean, trillions of dollars. We're taking trillions from people's paychecks, from taxation, and we're taking it for this thing that we think is a benefit to people, which is we're going to offer a service that is maybe a human right, a societal good. And surely the service we offer—we do have some of that stuff in there. Like, if you have a heart attack, you go to the doctor here, with or without insurance, they're going to open up that blockage, like, right now. That's a great thing. But along with that package deal, we're going to insert a few things that may or may not work that cost a lot of money. And all that's doing is taking lots of money from taxpayers and redistributing it to the shareholders of those companies. It's a huge financial system with the rare adverse event of helping someone's health. And the libertarian comes along and says, "I'd rather not pay the tax, have more skin in the game, decide what's right for me, and I'm the best person to decide how to use my own money." And I guess I do feel a sympathy to that point of view because this system has so many places where it can be taken advantage of, where people get something that doesn't help that much, that only may kill without any possibility of benefit, and you take a lot of other people's money to pay for that.

有一方面我非常同情。核心是：我们为美国医疗征了很多税——万亿美元级——从工资单里抽走，用来提供我们以为对人有益的服务，或许是人权、社会公益。那套服务里确实有好东西：你心梗了，有没有保险，这里的医生都会立刻打通堵塞，很好。但打包一起的，还有一些可能有效也可能无效、却很贵的东西。那做的不过是把纳税人的很多钱，再分配给那些公司的股东。这是一个庞大金融体系，偶尔附带改善某人健康的副作用。自由意志主义者会说：我宁愿不交那税，多一点「皮肤在局内」，自己决定什么对我合适，我最适合决定怎么花自己的钱。我对这个观点有同情，因为这套体系有太多可被利用的地方：人们得到帮助不大的东西，甚至只有伤害没有获益可能的东西，却用很多人的钱去付。

Yeah. I mean, one of the specific libertarian proposals—and this was something that was floated by Jim O'Neill, who was the deputy at HHS, another example of maybe the sort of interesting tension—you've got RFK and then Jim O'Neill, who once said that FDA should be rolled back to its pre-1962 mandate, where all it does is vet for safety. It doesn't even gatekeep based on efficacy. The market and doctors sort of will work that out. My question is: Are we headed that direction? With the way that medicine is changing, do you think the FDA is going to need to be reimagined somewhat?

一个具体的自由意志主义方案——HHS 副职 Jim O'Neill 曾提出——又是张力的例子：一边是 RFK，一边是 O'Neill。他说 FDA 应退回 1962 年前的授权，只审安全，甚至不按疗效把关，市场和医生自己解决。我们在往那个方向走吗？医学在变，你觉得 FDA 需要某种重塑吗？

I mean, I appreciate Jim O'Neill a lot, and I think he's got a lot of wise ideas. And I think I appreciate that he's very philosophically consistent. But let me use an analogy, because when we talk about safety, I think we mean two things, not one thing. OK, we say safety and efficacy is the mandate of the FDA since 1962. OK, when you get in your car and you turn the ignition, the first type of safety is you've got to make sure that car doesn't blow up, OK? You've all seen the mafia movie where the car blows up. OK, so that's a type of safety. We know the car can turn on, the gas line doesn't explode the car, like, it's safe. The next thing is efficacy. You drive down the street. Can the car actually go down the block? That's efficacy. OK, well, FDA, we definitely do the first thing. I think we definitely show in phase one and early-phase testing, your car's not going to blow up. Then we kind of do the second thing. We kind of make sure that cars go down the road a little bit. Some cars may not go as far as other cars, and sometimes we don't look at how far the car goes. We use the surrogate of the engine's running, it sounds like it's going to go. So we use the surrogate. So we kind of monitor efficacy. But that's not what we really mean for car safety. What we really mean is 1,000 Volvos have been driven 400,000 miles, and we know that the rate of car accidents and driver fatalities are lower than, let's say, I don't know, Chevy. Or—you get the point. See, that type—that's what people really mean by safety. That the Volvo is the safest car because with 400 million miles of follow-up, the driver is 20 percent less likely to die than other cars. OK, that is the part of the FDA that we don't do a good job. We have never done a good job, and we never will do a good job. It requires large sample sizes and unbiased data, and I think that there is very little effort to do that. So when people say things like, "COVID-19 shots absolutely do not cause miscarriage," and they cite an observational study where the women who got it and the women who didn't get it are different women—they chose to do it, right?—that's not really proving that it doesn't cause any miscarriage. When you administer a drug to lots and lots of people in a biased way, you can't really look for small safety signals. So I think that's a huge failure. So back to Jim O'Neill's point. If Jim O'Neill wants a world where we just make sure the car doesn't blow up when you start it, I think it's philosophically defensible. If he wants a world where we know that the car will run for many, many miles without causing more fatalities, that's a tougher pill. That's not very doable.

我很欣赏 Jim O'Neill，他有很多明智想法，哲学上也非常一致。但让我用类比：谈安全时，我们其实指两件事，不是一件。1962 年以来 FDA 的授权是安全与疗效。你上车打火，第一类安全是：车别爆炸——黑帮电影里那种。确认能打火、油路不把车炸掉，这是一类安全。下一类是疗效：车能不能开上路。FDA 肯定做第一类——一期和早期测试里，我们基本能证明车不会炸。第二类我们也做一点——确保车能开一段；有的车开不远，有时我们甚至不看开多远，只用「引擎在转、听起来能开」的替代指标。所以我们某种程度上监测疗效。但人们真正说的汽车安全不是这个。真正意思是：1000 辆沃尔沃开了 40 万英里，事故率和驾驶员死亡率低于雪佛兰之类。沃尔沃最安全，是因为有 4 亿英里随访，驾驶员死亡风险低 20%。那一部分 FDA 做得不好，从未做好，也永远做不好。它需要大样本和无偏数据，而努力很少。所以当人们说「COVID-19 针绝对不导致流产」，并引用观察性研究——接种与未接种的女性本就不同，是自己选择的——那并没有真正证明不会造成任何流产。当你以有偏方式给很多人用药，就很难找小安全信号。这是巨大失败。回到 Jim O'Neill：如果他要的世界只是「打火不炸」，哲学上说得通；如果他要「开很多英里也不增加死亡」，那就难吞得多，也很难做到。

Yeah. I mean, isn't this partly what Makary is trying to push for? He issued a memo saying the FDA is going to become more Bayesian. So we're going to look—Bayesian statistics is kind of like you're placing small bets on, like, probabilities that something is safe or not safe. And you can kind of try to zoom in more on a more individualized level, on subpopulations, instead of the one-size-fits-all approach. Is there a way that you see, from how you observed the machinery operating, that that can be pushed further? That sort of tracking results at that granular level over time, over those 400,000 miles, is something the FDA would be able to do, or, if we're post-FDA, some other organization would be able to do?

这不也是 Makary 想推的一部分吗？他发备忘录说 FDA 要更贝叶斯：对安全与否下小赌注式概率，更聚焦亚群，而不是一刀切。从你观察到的机器运转看，那种按 40 万英里粒度长期追踪结果，FDA 或后 FDA 组织做得到吗？

That's a great question. Well, I definitely think there's lots of value in the Bayesian methodology, and it will accelerate products to market. It will leverage data from one disease to another disease, one drug to a sister or brother molecule. So I think there is lots of value in Bayesian statistics. On this question of really safety, let's talk about it. Let's imagine I come up with a drug that improves depression, and it really improves depression. But what if it increases the rate of heart attacks by four percentage points? Not 40, not 80 percent, but, like, 4 percent, or 2 percent, or half of 1 percent. At a population level, that could be very bad, like a tiny increase in heart attacks, but it might be very, very difficult to find. And here's why. I debut my new depression medicine. Who are the first people who get it? It's not the average person with depression. It's going to be the wealthiest person with the best health care and the best insurance. They're going to be the first people to take it. And that person's rate of heart attack might be a little bit lower than the other depressed people who are not as well-educated or literate or health-conscious and these kinds of things. So I think we do have a challenge with phase four post-market surveillance for safety. We have a broad problem with it. We have very weak methods, I think. And I don't think Bayesian will get around that problem because the problem is the types of people who take it first are different than those who take it second or third.

好问题。贝叶斯方法绝对有价值，会加速产品上市，把一种病的数据借到另一种病、一种药借到姐妹分子。安全问题上：假设我发明一种确实改善抑郁的药，但它让心梗率上升 4 个百分点——不是 40、80，而是 4%、2% 或 0.5%。人群层面可能很糟，却极难发现。为什么？新抗抑郁药最先用的不是平均抑郁患者，而是医疗与保险最好的最富有的人。那群人心梗率可能本来就低于教育、健康意识较差的抑郁患者。所以四期上市后安全监测有挑战，方法很弱。贝叶斯绕不过去，因为最先用药的人和第二、第三批不同。

Well, I mean, another person who has been—another prominent voice who's been raising concerns about this—because when you're looking at the risks of drugs, there are two sides of the equation. There's the risk of approving it and then the risk of not approving it, because if it is an efficacious drug, how many people who would have had access to it earlier could have had their lives saved or prolonged or improved over that time period? And someone who's raised that issue in the age of AI is Dario Amodei, the CEO of Anthropic. And I'm just going to read you his quote, because he specifically called out the FDA, and I'm wondering what you think of this. And we've already seen AI being integrated into biotech labs. So we know that the idea here is to try to use AI to individualize, like, you know, drugs targeted to specific individuals, genomes, and so forth. And he wrote that, "Regulatory systems were designed for a slower pace of innovation and we are not prepared for the deluge of new products and advances that AI will bring. AI may also make these downstream technologies safer and more predictable in a way that violates the skeptical assumptions of regulatory agencies like the FDA." If Amodei is right about the effect AI is going to have on the field, do you think that the FDA is going to be able to adapt to that future?

另一边是不批准的风险：如果药真有效，早获批本可拯救或改善多少人？Anthropic CEO Dario Amodei 在 AI 时代提出这个问题。我读一段他点名 FDA 的话：「监管体系为更慢的创新节奏设计，我们没有准备好迎接 AI 带来的新产品与进步洪流。AI 也可能让下游技术更安全、更可预测，从而违背 FDA 这类机构的怀疑假设。」如果他对 AI 影响判断正确，你觉得 FDA 能适应那个未来吗？

Well, it's a great question. I guess, let me start by saying, I mean, I definitely see kernels of truth in what he's saying, but maybe I'm not as much of—I don't go all the way he goes.

好问题。我先说：他的话里绝对有真实内核，但我不会走到他那么远。

Sure.

当然。

So where I see, like, the big core truth is, I think the FDA tries to regulate AI itself, medical AI. You wear a watch that's supposed to give you information, and the FDA wants to do a lot of that regulation. That's a very tough thing to regulate because this technology is getting so—it's changing so much faster than our ability to judge it. And I do agree with Marty and others who think that that's probably not the best role, for regulating all the potential aspects of digital health and health AI. And, for instance, you can imagine the absurd where, you know, should government regulate—I'm a doctor. I'm seeing a patient later this afternoon—should government regulate the apps I can use to read, to, like, learn about the disease or ask questions? You know, should it regulate OpenEvidence and those guys? You know, you could ask that question. I don't think it should.

我认为最大的真实内核是：FDA 试图监管 AI 本身、医疗 AI。你戴一块表想拿信息，FDA 就想管很多。这很难管，因为技术变化远快于我们的判断力。我同意 Marty 等人：监管数字健康与健康 AI 的所有可能方面，大概不是最好的角色。你可以想象荒谬情形：我下午要看病人，政府该不该规定我能用哪些 App 去读、去学病、去提问？该不该管 OpenEvidence 那些？我不认为该。

I mean, you could ask the question. I just spoke to a company called Doctronic that is acting as an AI prescriber in Utah. Utah is allowing the AI to refill prescriptions. So that's another example of where these questions are going to have to be answered, of where does the government step in and where does it step back.

你可以问这个问题。我刚采访过犹他州的 Doctronic，AI 在那里充当处方者，犹他允许 AI 续方。这又是一例：政府该在哪里介入、哪里后退，问题必须被回答。

And I think I have a general philosophic feeling that probably government is much more likely to get in the way of these kinds of innovations. It's changing so quickly, it's going to be very difficult for government to regulate that. Now, you talk about drug discovery and drug science and those kinds of aspects of AI. I think if I was a pharmaceutical firm, I would definitely invest in AI. I think there are so many things around running clinical trials that we can do better with AI, help us run them cheaper and faster and more efficiently. But I do think when it comes to molecule discovery and basic science, I'm not as optimistic as Dario for a couple reasons. One, I think a lot of the information that is fed into models about cancer biology is basically as close to fraudulent research as you can imagine. We're talking about, like, the Stanford president whose Western blots—with Photoshop kind of research. You've got research that's not reproducible. It's not just my opinion. Many companies have taken samples of the literature, and they try to replicate it in their own labs, and they have massive strikeout rates, you know? So if you train AI on garbage, it's just not going to—like, what can it learn? It's trained on, like, inaccurate information. So I think that's a challenge it faces. The second challenge is AI will be happy to give you hypotheses to study, but you'll still need to kind of run it in a few people to kind of validate those hypotheses. I suspect the limiting reactant is not coming up with ideas. We have so many—we have more ideas than we can study with people. The limiting reactant is getting the people to consent and manufacturing the products and those kinds of things. I hope he's right, and if he is right, it sounds like a great future. But I'm a little bit skeptical that he's totally right because I think the biology of it is a lot harder.

我有一个总体哲学感觉：政府更可能挡住这类创新。变化太快，政府很难监管。谈到药物发现与药物科学那些 AI 应用：如果我是药企，我肯定会投 AI。临床试验运营有很多地方能用 AI 做得更便宜、更快、更高效。但在分子发现与基础科学上，我不像 Dario 那么乐观。一是喂进模型的癌症生物学信息，很多近乎欺诈——斯坦福校长那种用 Photoshop 的 Western blot 研究、不可重复的研究。不只是我的看法：许多公司抽样文献，在自家实验室复现，出局率极高。垃圾进，AI 能学什么？二是 AI 乐意给你可研究的假说，你仍需要在少数人身上验证。限制因素不是出点子——点子多到研究不过来；限制因素是让人知情同意、把产品造出来。我希望他对，如果对，那是美好未来。但我有点怀疑他是否完全对，因为生物学难得多。

What about the role of the FDA in this biohacking movement, which has become more popular? You mentioned peptides recently. That's the new, sort of, frontier of all this. People are going to these compounding pharmacies, and they're getting peptides for, quote, "research purposes," and it's causing some concern in the media and maybe in the health establishment, and calls that maybe the FDA needs to get more aggressive in this area. What's your assessment?

生物黑客运动更流行时，FDA 的角色呢？你刚提到多肽，那是新前沿。人们去复配药房拿「研究用途」多肽，媒体和健康建制有些担忧，有人呼吁 FDA 更强硬。你怎么评估？

Yeah, I feel like it's the same. But we already struggle with this tension between there are many, many people selling products that are on the cusp of what we can regulate in biologics. How much modification does it have to undergo before it falls under our purview? Versus if it's just a simple—like, if I take a piece of your skin, I can graft it on the other part of your skin. It doesn't go through FDA regulation, for instance. OK, so, but there are people playing around the edge of this for years, and we have enforcement discretion, where we choose to enforce the rules or not enforce the rule based in part on if the juice is worth the squeeze, the patient communities, and those kinds of things. And I think they're going to continue to walk that line. But to me, what's interesting is where you've got the compounder and they're making, like, retatrutide, Eli Lilly's product, and you've got a lot of people taking it, and they are losing weight, and it looks very similar to the clinical study, and you don't have adverse events different than the study reported. What do you do in that space? Of course, the company has a strong interest in killing that market off, and they're probably going to lobby hard to kill it. But is it actually a public health risk, or is it the perception of a public health risk? People always say, "Well, you know, the compounding pharmacy can go bad." That's true, but so can the factory, you know, the actual manufacturing plant.

我觉得还是同一张力。我们本就在挣扎：很多人卖的产品处在生物制品监管边缘。要改到什么程度才落入我们管辖？相对地，如果我取你一块皮移植到别处，就不经 FDA。边缘上玩的人很多年了，我们有执法裁量：是否执行规则，部分看值不值得、患者社群等等。他们会继续走这条线。但有意思的是：复配药房做礼来的 retatrutide 一类产品，很多人在用、在减重，看起来很像临床研究，不良事件也不比研究报告更糟。那你怎么办？公司当然有强烈动机掐掉这个市场，会大力游说。但这真是公共健康风险，还是「看起来像」公共健康风险？人们总说「复配药房可能出问题」——真的，但正规工厂也可能出问题。

I think that a lot of people are going to watch this interview and wonder, why aren't you still at the FDA? Your second departure in April of this year—then-FDA chief Marty Makary said your exit was preplanned to coincide with your leave from UCSF, where you still teach. On the other hand, STAT News reported around that time, based on talking to several of your employees, that you were clashing with career bureaucrats, people within the machine, and that they thought your management style was creating, quote, "an environment rife with mistrust and paranoia." So what is the truth? Why did you really leave permanently for the second time?

很多人看完会想：你为什么不还在 FDA？你今年 4 月第二次离开时，时任局长 Marty Makary 说离任是预先安排、配合你在 UCSF 的假期，你仍在那里教书。另一方面，STAT News 当时根据多名员工说法报道：你与职业官僚冲突，管理风格造成「充满不信任与偏执的环境」。真相是什么？你第二次永久离开的真正原因？

All right, well, first I want to say one thing about how they report. OK, you know, like, the reporting in this space is really bad. OK, we've got the big outlets like The New York Times and The Washington Post. They only want to report on a story if it has to do with Robert F. Kennedy Jr. That's their only interest, because if it's not Robert F. Kennedy Jr., they don't care. They don't care about chikungunya or Replimune or all these things that came up. They just don't care about those topics. They don't interest their readers. They don't think it's broadly interesting. And so they, poof, they're gone. Then you've got a group of people that write at outlets for investors. Their audience is investors, and they're writing for investors, and that's their prime business. It's like, who wants to read about this small company except the investors in the company? And what's their method to say that my leadership style is whatever they say? They get one person they've known for years at the FDA, calls them up, says, "I don't like this guy, and here's three of my friends who are going to call you up." They're not randomly picking the employees to get a sense of the tenor or tone or anything like that. So I think that's all just complete nonsense, like, what the leadership style—go to CBER and just literally pick 50 random people and ask them what you thought of me. And I'm happy to accept whatever they said if you pick them randomly. I'd suspect they'll say mixed things, like any boss. You know, that I'm really interested in science and I push back on some things, but then there are things I'm indifferent to. OK, the next thing I'd point out is it is true that I only had a one-year leave to go do it. Then who knows? They'll give away my job here, you know, and I lived here the whole time. That's no secret, you know. I was going back and forth. And my goal in life is not to be a career regulator. That was never my goal in my life. I was doing it because I thought it was a public service, and if you talk so much about the agency and you get a chance to work in the agency, surely you'd be a hypocrite for not taking that chance. But I do note my leaving, which coincided with the commissioner leaving and with Tracy Beth leaving CDER. And what I find fascinating is there's not a single news outlet that can tell me how Tracy Beth left. Because Marty had left, I had left, and then Tracy was relieved of duty one day suddenly. And Politico reports that Robert F. Kennedy Jr. doesn't even know she wasn't working there anymore. So who took her out? Not a single news outlet's interested in that story. I find that fascinating.

先说报道方式。这个领域的报道很糟。《纽约时报》《华盛顿邮报》这类大报，只有挂上 Robert F. Kennedy Jr. 才想报；不挂就不关心。基孔肯雅、Replimune 这些议题他们不关心，觉得读者不感兴趣，于是「噗」就没了。然后有一群给投资者写的媒体，读者是投资者，主业也是这个——谁会读这家小公司，除了投资者？他们怎么得出我的领导风格怎样？找一个认识多年的 FDA 人打电话：「我不喜欢这家伙，再介绍三个朋友打给你。」他们不是随机抽员工去感受气氛。所以领导风格那套全是胡说。去 CBER 随机找 50 个人问对我的看法，我愿意接受随机抽样的结果。我猜会像任何老板一样好坏参半：我对科学很投入、会顶一些事，有些事我无所谓。其次，我确实只有一年假期去做这件事，谁知道岗位会不会被拿走；我一直住在这里，来回跑，这不是秘密。我的人生目标不是当职业监管者，那从来不是目标。我去做是因为觉得是公共服务——你谈了那么多这个机构，有机会进去，不去做就是伪君子。但我注意到我离开时，局长也离开了，Tracy Beth 也离开 CDER。有意思的是：没有一家新闻能告诉我 Tracy Beth 怎么走的。Marty 走了，我走了，然后 Tracy 有一天突然被解除职务。Politico 报道 Robert F. Kennedy Jr. 甚至不知道她已经不在岗。谁把她拿掉的？没有一家媒体对这个故事感兴趣。我觉得这很迷人。

People who hear about you leaving, Makary leaving, Tracy leaving, the impression that many will get in the MAHA movement is, "Well, here it is. Here's Big Pharma pushing out the dissidents yet again." How accurate or inaccurate is that?

人们听到你离开、Makary 离开、Tracy 离开，MAHA 运动里很多人的印象是：「看，大药厂又把异议者推出去了。」这有多准确或不准确？

I think all government reform is limited by threatening the profits of very rich people. I think all reform will be limited by that. And where MAHA will succeed is where the money and the mission go together, but in the spaces that we were in, the money and the mission go in different directions. And so I think it's an uphill battle.

我认为一切政府改革都会被「威胁很有钱的人的利润」限制。所有改革都会受此限制。MAHA 能成功的地方，是钱与使命同向的地方；我们当时所在的赛道，钱与使命经常反向。所以是一场上坡战。

One of your persistent criticisms has been the revolving door. You mentioned your predecessor, Peter Marks, earlier.

你持续批评的一点是旋转门。你前面提到前任 Peter Marks。

Oh, you mean the Eli Lilly vice president of vaccines?

你是说礼来疫苗业务副总裁吗？

Right. That's what I was getting at. Is that still looming over government as a problem, in specifically public health?

对，我就是想问这个。这在政府里、尤其公共健康里，是否仍是悬在头上的问题？

Absolutely. Public health—it's the biggest… I see Ashish Jha, who is the White House COVID coordinator, he says, you know, he thinks it's lab leak after all. It's funny. He just came to that realization when he created—what is it called?—BioRadar, his company that helps people solve lab leaks, you know? It's like, what a coincidence. He suddenly realized, that's a lab leak. I just got a company that works on this issue. Bob Califf, revolving door of a company. Scott Gottlieb—oh, he's always quoted as the FDA commissioner. "Scott Gottlieb thinks you should get your Pfizer vaccine." You mean Pfizer board member Scott Gottlieb thinks I should get a Pfizer vaccine. So why do I think it's a problem? I think that most of the people who work at the FDA are super good people, honest people. A few people working at the FDA are definitely making decisions with the goal of wanting to work for these firms when they're done.

绝对是。公共健康——最大的……我看 Ashish Jha，白宫 COVID 协调员，他说到底还是实验室泄漏。有趣。他创办了帮人解决实验室泄漏的公司 BioRadar——名称大概如此——才突然醒悟。真巧：他刚有一家做这事的公司，就意识到是实验室泄漏。Bob Califf，旋转门。Scott Gottlieb——总被引为「前 FDA 局长」：「Scott Gottlieb 认为你该打辉瑞疫苗。」你是说辉瑞董事 Scott Gottlieb 认为我该打辉瑞疫苗。为什么我认为这是问题？我认为 FDA 多数人超级好、诚实；少数人做决定时，确实看着卸任后想去这些公司。

So is the fix to that to have some sort of moratorium or amount of time before you're allowed to be employed by industry?

解法是不是设一个冷却期，一段时间后才允许进行业？

I don't know. Who would do it? To be honest, you already take the terrible pay cut to be in government service. A lot of these people are doctors, and it's difficult for them to have a practice. To me, of all the things I miss the most, I miss my clinic the most. I miss that part of—I always say, you can undo everything I did at the FDA, but you can't undo my last week of clinic. If you really did something, it's very tangible. I think that's a downside of the employment. A lot of these roles, you don't have a lot of autonomy. And so if you take away the ability to work in the industry, I think you might kill off the entire—who would even work there? Moratorium, I'm not sure that's the right answer. I'm genuinely unsure of how to create enough incentive to get great people to work there, but also to safeguard against these perverse interests. And I don't have the answer to that.

我不知道。谁会来做？坦白说，进政府已经大幅减薪。这些人很多是医生，很难维持门诊。我最想念的是诊所——我常说：你可以撤销我在 FDA 做的一切，撤不销我上周门诊做的事。真正做成的事很具体。这类岗位自主权不多。若再拿走进行业的可能，可能把整条人才链掐死——谁还愿去？冷却期是不是正确答案，我不确定。怎样既吸引优秀的人，又防范扭曲利益，我真心没有答案。

Are you glad that you went to the FDA?

你高兴自己去过 FDA 吗？

I am glad because I feel like, you know, how often in life do you get to do a job where you really see and learn a lot about things you had only talked about or read about before? That's one. And, you know, like anything, you get offered these opportunities only once in a life to go do something like this. So I'm glad I did it.

我高兴，因为人生里有多少机会能做一份工作，让你真正看见并学到以前只谈过、只读过的东西？这是其一。而且这类机会一生往往只有一次。所以我高兴自己去做了。

You sort of rose to fame as this COVID critic, COVID dissident, and critic of the lockdowns, masking children, vaccine mandates.

你某种程度上是作为新冠批评者、异议者、封锁与儿童口罩与强制接种的批评者成名的。

I thought you were going to say because of the book Malignant.

我还以为你会说是因为《Malignant》那本书。

No.

不是。

It wasn't that. That didn't catch your eye?

不是那本？没吸引你注意？

We talked to you at one point about a piece you wrote arguing that the public health establishment was right—it's right that they lost your trust. Do you think that anything has happened, that it's time for people to start regaining trust in public health?

我们曾聊过你写的一篇：公共健康建制失去你的信任是对的。你觉得现在发生了什么变化，是否到了人们重新信任公共健康的时候？

Oh, no way. Oh, no way. No way. No way. I wouldn't trust it at all, yeah.

噢，绝不可能。绝不可能。不可能。不可能。我一点都不会信任，对。

What still needs to happen for public health to earn back, legitimately, the trust of the public?

公共健康要正当赢得公众信任，还需要发生什么？

Boy, you remember monkeypox? And I remember public health experts said, maybe every kid should get—every college kid should get a monkeypox vaccine before going to college. I said, "Do you know how monkeypox spreads?" It's not every college kid. "Kids should wear masks in school because of monkeypox." This is what, like, a former surgeon general said. They're completely wrong. OK, so that was just one example. What can they do to regain trust? I don't know if it's even possible. I think it's just so fragmented now. You ask people, and they tell you with a straight face, like people I know, "Anthony Fauci, you know, he made no mistakes. Literally did the best job he could with the information he had." And then I said, "Let me just focus on one tiny thing. He did say you should take your 24-month-old kid and put a cloth mask on that kid all day in day care. He said that. You don't think he had any clues at the time that that was a dumb idea?" I mean, it's obviously dumb, right? So, like, that's their position. On every issue, I'll give you another example. There was the outbreak of—what is it? Cyclospora. And there was a public health doctor from San Diego who was quoted on NBC that says, for the next few weeks, just don't eat any fresh fruits or produce at all. Give up all fresh produce. Can you imagine how myopic you are? OK, so yes, there's an outbreak. You mean to tell me for a few weeks you want everybody in America, or whatever, to not eat fresh fruits and vegetables? What will happen to the agriculture industry? What will happen to my blood cholesterol? What will happen to my fiber intake? Some of those people may never go back to eating vegetables, a tiny fraction of them will gain weight. Public health is so myopic. It doesn't understand that you have to look at the whole issue. And isn't that a perfect analogy for COVID? You know, "Oh, just don't go outside. Just stay in your house all day." As if human beings don't need contact with other people and see face to face. As if that doesn't matter at all. "Just don't eat fresh fruits and vegetables." So public health has not learned its lesson. The problem with public health, I think, is that they're completely politically captured now. Public health and the far-left wing of the Democratic Party are synonyms. There's no political balance on there. I think a little balance would go a long way. A little bit of open-mindedness would go a long way in public health. A little humility to just admit a few things we got wrong in the pandemic. They closed schools in this city for 18 months. That was just a self-inflicted wound. Just hurt the kids of this city. And it didn't hurt the rich kids in private school. Those kids went—you know, those schools ran. It hurt the poor kids in public school, which is the exact opposite of the progressive philosophy. So I never understood that.

还记得猴痘吗？公共健康专家说，或许每个大学生进大学前都该打猴痘疫苗。我说：你知道猴痘怎么传播吗？不是每个大学生。「孩子该在学校戴口罩因为猴痘」——某位前卫生局长说的。完全错。只是一例。怎样重获信任？我甚至不知道是否可能。现在碎片化太深。有人一本正经告诉你：「Anthony Fauci 毫无错误，在当时信息下做到了最好。」我说：「只聚焦一件小事。他说过该让 24 个月幼儿全天在托儿所戴布口罩。他说过。你不觉得当时就该有线索知道那很蠢？」显然很蠢。他们的立场就是这样。再举一例：环孢子虫暴发时，圣地亚哥一位公共健康医生在 NBC 上说，接下来几周干脆别吃任何新鲜蔬果。放弃所有新鲜农产品。你能想象多短视吗？是有暴发，但你是说几周内美国所有人都不吃新鲜蔬果？农业怎样？我的胆固醇怎样？纤维摄入怎样？少数人也许再也不吃蔬菜，一小部分会发胖。公共健康太短视，不懂要看整盘棋。这不正是新冠的完美类比吗？「别出门，整天待家里。」好像人不需要面对面接触。「别吃新鲜蔬果。」公共健康没吸取教训。问题是它已被政治完全俘获。公共健康与民主党极左翼几乎是同义词，没有政治平衡。一点点平衡、一点点开放心态、一点点谦逊去承认疫情里几件做错的事，都会走很远。这座城市关校 18 个月，是自己造成的伤，伤的是本市孩子；私立学校的富孩子继续上课，伤的是公立学校的穷孩子——这与进步哲学正好相反。我从未理解。

But, I mean, the federal public health apparatus is still in control, still staffed at the top by RFK Jr., Jay Bhattacharya is still there. Is that not having some sort of trickle-down effect or countercurrent?

但联邦公共健康机器仍由 RFK Jr.、Jay Bhattacharya 等人在顶上掌控。这没有某种向下渗透或逆流吗？

I don't know. I just don't think it's—I mean, don't get me wrong, I love Jay, and I think Jay's heart's in the right place, and Jay is going to—he's already made some really important changes. And I agree a lot with what the kernel of Bobby's ideas—I agree with the kernel. I say the kernel because I can think of a way that it makes sense, and I can also think of ways it doesn't make sense. But, you know, people, before I went to government, people told me that there is a fourth branch of government, and it's the career state employees. And I never believed that to be true, but now I'm certain that is true, that you have a lot of people who are in government. They tend to be in just three or four counties in one area, a blue pocket of America. They have strong views, and they really do a lot of the governance of this country. They make the decisions that regulate all of us in a way that's unaccountable to Congress and unaccountable to the president. And I suspect they'll continue to stay. But I think the COVID pandemic revealed to so many people that we made mistakes, and that distrust in medicine and public health will just continue to grow, and that there will continue to be more of these kinds of reckonings in the years to come.

我不知道。别误会，我爱 Jay，认为他心在正确位置，也已经做了一些重要改变。Bobby 想法的内核我同意很多——我说内核，是因为我能想到说得通的方式，也能想到说不通的方式。去政府前有人告诉我存在政府第四分支，就是职业公务员。我以前不信，现在非常确定：很多人在政府里，往往集中在某几个偏蓝县域，观点很强，真正做着很多治理，以对国会和对总统都不问责的方式监管我们所有人。我怀疑他们会继续留着。但疫情让许多人看见我们犯了错，对医学与公共健康的不信任会继续增长，未来还会有更多这类清算。

Last question. What is next for you? What are you doing now?

最后一个问题。你接下来做什么？现在在干什么？

I'm the vice president of Eli Lilly vaccines. No, just kidding. Joining Peter in the back. No, I'm just kidding. You know me. You know, I am back to doing what I love. You know, I'm a doctor by training, and so, to me, that was why I got into health, because I like to be in clinic, and I still like to be in clinic. I still like to be on rounds. I think it's the most interesting part of medicine. You see a person, you think about their problem, you talk to them about their problems, you advise them, you help them make better decisions. And so I love doing that. I like making the videos, like you might make the videos. I'm on YouTube, and I'm on Substack writing for Sensible Medicine. And I don't know, I'm taking a much-needed rest and not in a hurry to get on to the next thing. I'm a professor. You know how professors are. We just like to sit around and talk.

我是礼来疫苗副总裁。开个玩笑。去找 Peter 会合。开玩笑。你了解我。我回到了自己爱做的事。我科班是医生，进入健康领域就是因为喜欢诊所，现在仍喜欢诊所、喜欢查房。我认为那是医学最有意思的部分：看见一个人，想他的问题，和他谈，给他建议，帮他做更好决定。我爱做这个。我也喜欢做视频，像你做视频那样。我在 YouTube，也在 Substack 为 Sensible Medicine 写作。我在好好休息，不急着上下一件事。我是教授——你知道教授什么样，就喜欢坐着聊天。

OK, well, yes, you can read Vinay Prasad's writing at Sensible Medicine and also your Substack, Vinay Prasad's Observations and Thoughts, and subscribe to your YouTube channel. Thank you so much for sitting down and talking with me today.

好。读者可以在 Sensible Medicine 和你的 Substack「Vinay Prasad's Observations and Thoughts」读到他的文章，也可以订阅他的 YouTube 频道。非常感谢你今天坐下和我聊。

It was a pleasure.

我很荣幸。