监管前沿The Regulatory Frontier
我们与三位前沿创始人的四部分系列讨论之第三部分： 吉列尔莫·劳赫（Guillermo Rauch）（Vercel）、布莱克·肖尔（Blake Scholl）（Boom Supersonic）与 马克斯·霍达克（Max Hodak）（Science Corp）。*
另见第一部分： 浪费代币，节省时间，第二部分： 氛围编程硬件，以及第四部分：自主公司（即将推出）。
监管领域的红皇后竞赛
布莱克： 在监管方面，我们观察到的一件事是——它极大地抑制了人们对改变的意愿，也严重拖慢了迭代速度。举个例子：假设你要给一架飞机做认证。你要完成的无数事项之一，是证明它能承受雷击。这份测试计划的监管文件可以长达 200 页。按传统做法，你会雇一个——坦白说——不算特别聪明的工程师，愿意坐在那里对着键盘敲敲打打，写 200 页的合规性监管文件。这要花上好几个月。而且，如果你改变了飞机的设计，那你就想哭了，因为又要花两个月重做这些机械性的合规文件。
我们发现，我们可以构建一个 RAG，基本上可以让我们在——姑且称之为几分钟——之内，靠提示词一路搞定所有这些工作。一阶效应是你省下了大量时间。二阶效应是，如果你改变了飞机的规格，现在只需要几分钟而不是几个月。所以你真的可以愿意去改变。三阶效应是，你可以淘汰那些不太出色的工程师，只留少数真正有创造力的人快速迭代，因为改变的成本下降了。从某种意义上说，整个监管负担——它确实严重损害了迭代能力——就这样消失了。
马克斯： 这是当下 AI 领域一个被严重低估的故事。硅谷的共识是监管很糟糕——我们想走得更快，我们想实现这个令人惊叹的未来，我们想要富足、繁荣，任何拖慢那个未来的东西都应该避免。当然，我们确实过度监管了。我们已经让建造东西变得不可能。在很多地方，建造任何实体东西所牵扯的流程简直疯狂。
但很多监管本身并不是问题。如果你真的读过其中很多条文——城市不被雾霾笼罩是好事。能在很多条河里游泳是好事。其中很多都是进步。问题在于，人类很难去理解并遵守这些条文，而且每次你都得和政府交换一封信，一等就是几个月。如果你能把我们学到的东西中的很大一部分变得完全无摩擦，那就太棒了。我认为这是一个被低估的故事。
纳瓦尔： 直到监管机构也开始朝我们喷出一堆 token。然后你开始收到监管机构发来的海量文件，你还必须遵守，这就是代理对代理的战争。但至少这是一场公平的战斗。
马克斯： 那基本上就是我们现在的情况。
布莱克： 其实我倒觉得，那会比现在的情况有所改善。眼下最糟糕的事情之一是，如果你想建造任何实体东西，你得先拿到建筑许可证。在证明清白之前，你都是有罪的。我们遇到过最糟的是消防部门，因为他们拥有道德背书——把人从燃烧的建筑物里救出来的人——然而他们实际做的，只是把你们的建筑设计折腾好几个月。如果我们能用代理取代消防局长，快速对你的建筑方案提出批评——哪怕它的反馈过分了——也比今天这种拖延要好得多。
吉列尔莫： 当马克斯说这可能是一件好事——我们有所有这些监管——的时候，我脑子里想的是：让代理成功的，是人类或其他代理设置好正确的测试护栏。人们对 slash goal 或 Ralph 循环这类方法非常兴奋，也就是你告诉模型："去做这件事，这就是你的退出标准。"我对布莱克说："去让我们所有人都坐上超音速飞机吧。你的退出标准是你已经遵守了所有这些法规。"完全存在这样一个世界：我们说这些法规很棒——它们就像我们的测试套件。只要通过它们不会产生矛盾，而且这些法规确实合理，它们就是极好的护栏。否则我们就是把劣质货直接往天上送。
纳瓦尔： 这会演变成一场红皇后竞赛。他们会有代理，我们也会有代理。我觉得我们的代理可能更好——这是好事，总好过人与人之间的对抗。但他们的周期时间、响应时间可能会变长。App Store 现在正被垃圾信息淹没。我敢肯定专利局也被垃圾申请淹没了。这些机构采用 AI 会很慢。他们会遭到聪明企业家的 DDoS 攻击——用海量文件把他们的系统压垮。随着突然被洪水般的申请淹没，这些东西的审批时间可能反而会延长。
为什么医疗领域没有创新
布莱克： 这创造了一个真正改变监管模式的机会。想象一下，如果我们像今天建造东西那样在城市里开车。在你出发去任何地方之前，你得先写一份计划，寄给某个监管机构，然后等待。你的计划必须写明："我们将走某某路线，以这个限速行驶，使用转向灯，在每个停车标志前停下，绝不闯红灯"，等等等等。三个月后你收到回复："我们认为你应该走另一条街。"最后你获得批准，开车去了某个地方。这太疯狂了——你哪儿也去不了。然而，这正是我们在美国建造实体基础设施的方式。我们真应该让更多这类事情变成"事后执法"型，而不是"事前审批"型。
马克斯： 我也不想被过多——如果我向很多人交付一款医疗设备，那就必须有——这里存在未知数。我们很负责，我们做了临床试验，我们报告了所有数据，但是——
纳瓦尔： 马克斯，这就是为什么现在医疗领域创新这么少。FDA（美国食品药品监督管理局）的审批流程是一场噩梦。事实上，过去十年硅谷科技领域最大的两项进展——AI，以及更早的加密货币——都属于数学领域，因为那是最后一个不受监管的领域。一旦他们开始监管前沿模型、开始监管 GPU，那也会停下来。彼得·蒂尔哀叹实体领域没有创新。嗯，那是因为它被巨大的监管壁垒拖住了。
你总能找到一个吓人的案例——某种疫苗，或一场著名的医疗灾难——但监管无处不在，触角伸向四面八方，还有这么多互相矛盾的监管机构。SpaceX 被起诉，原因是招的——我忘了具体是什么——移民或难民或其他什么不够，但另一边又有政府法规规定他们不被允许雇用这些人，因为他们不是公民。这不是那种必须在同一个地方编译的逻辑代码。这是遍地随意编造出来的监管。你可能遵守了一个州的法规却违反了另一个州，在那边违反了联邦法规，惹恼了这边的某个人，而那个人选择起诉五十个人中的一个——恰好是他的朋友。这是任意的。这是反复无常的。
布莱克： 而认为这让事情更安全的说法，完全是神话。看看波音。他们认证了737 MAX，这架飞机只有一个传感器，却对飞机的抬头、低头姿态拥有完全的控制权。没有哪个实习生会蠢到认为这是个好主意。可它却一路通过了整个认证体系。这些东西实际上并不会让我们更安全，只是让我们更慢。
马克斯： 嗯，这里肯定存在功能失调。我认为其中一部分确实让我们更安全，就像 NRC（美国核管理委员会）让我们更安全一样——他们的职责是确保核能安全，而他们的做法是从七十年代起直到我想是一年前，一个核电站都没批准。如果我们从不建造任何核电站，那当然绝对安全。
我想说清楚——在很多这类事情上，我站在放松监管的一边。我同意布莱克的观点，其中很多可以做得更高效。但我也觉得，说"这只是 FDA、只是那些机构的问题"有点太轻描淡写了。问题更深。如果 FDA 批准了十种非常重要的药物，他们得不到任何功劳。而一个病人死了，他们就会被拖到国会面前挨骂。他们的激励机制有严重的负面偏向。现实是，这反映了美国人民的信念。在人体受试者研究所承担风险的感知，与我们获得新药的速度之间，存在一种权衡。
布莱克： 这完全是不对称的。如果你批准了一件坏事，你的职业生涯就完了。如果你否决了一件好事，没人会注意。这就造成了一种不对称的减速。我认为这是监管国家最需要解决的问题。
马克斯： 这是一个非常深刻的问题，因为问题就出在选民身上。我们会就未来正在推进的一些项目做民意调查，了解美国人民的态度。如果你逼得太紧，你可以绕道而行——去 Próspera，有各种办法试图走得更快。但如果你被视为坏玩家，你就会被我们身处的社会拒之门外。这才是你需要给出答案的事情。这比只说"我们需要监管改革"要深刻得多。
我们需要一场真正的五十州实验
纳瓦尔： 马克斯，你说到了点子上——问题就在选民、公民那里。我们喜欢责怪政客。你在 X 上会一直看到这种情况——人们会说："这个政客，那个政客，还有那个政客。"他们是靠多数票选出来的。这正是民意所在。那就是一揽子方案，那是他们选择的组合。你可能不喜欢这一届，但如果你把这个人拿掉，会有某个非常相似的人取而代之，因为选民会照样把他们投回来。
从文化层面看，大多数人都很难理解我们失去了什么、错过了什么。法国——X 上有一位法国企业家哀叹，57% 的 GDP 被政府吸走了，所以你没法创办公司。但对普通法国公民来说，这一点并不显眼。他们注意不到自己错过了什么。他们只知道，自己比美国人稍微穷一点。《经济学人》刚发了一篇小文章——三十年后，经济学家们终于转回资本主义立场——讲美国如何超越所有人，增长更快，体量更大。但他们马上又话锋一转，说："那是因为海洋，因为自然资源"——什么都说，就是不说资本主义。他们不想说出那个肮脏的 C 开头的词，因为不知为何，这些杂志在某个时刻都变成了马克思主义者。他们无法设想或想象，如果我们当初只是稍微更自由放任一点、更开放一点，本可能会是什么样。
我很想看到五十个州之间进行一场真正的实验。不同的监管，不同的税收结构。现在，联邦税收结构和联邦法规主宰着一切。但想象一下，如果你得了癌症，可以去某个小州，尝试每个人正在捣鼓的每一种药物。买者自负——你得自己做研究。这就是所谓的实验区。无人机也一样。飞机也一样——稍微难一些，因为你得飞越很多区域——但没错。
布莱克： 这里面有某种神奇的东西——创新区这个概念。我们有严重的 NIMBY（"别建在我家后院"）问题。但如果你创建自愿加入的 YIMBY（"欢迎建在我家后院"）区域，它们就创造了那个实验框架。按定义，它发生在人们自愿同意的地方。你可以尝试不同的规则，或者没有规则，或者不同的执法方式——先假定清白，再证明有罪——然后看看实际会发生什么。创新后果是什么？安全后果是什么？然后成功经验可以传播开来。
马克斯： 针对纳瓦尔的观点，创新区并不能解决药物研发中的问题。《尝试权法案》（Right to Try Act）通过有一阵子了。我们有单患者 IND（Single Patient IND）这条途径的时间比那要长得多。如果你的医生打电话给 FDA 说："我想给我的病人用未经批准的药物"，他们批准的比例超过 99%。他们甚至可以在电话里就批准。
问题是，要给病人用药，你仍然需要临床级的药物。唯一拥有这些药物的，通常是正在开展临床试验的知识产权所有者——他们为制造这东西投入了数亿美元。如果你的病人——他可能本来就已经病得很重——出了什么事，FDA 会做出不利推断，而这被视为该药物的一种属性，是全球性的——与你的创新区无关。所以有两个问题。第一，你需要让知识产权所有者分给你一些他们的药——他们不会这么做的。第二，你需要防止全球性的监管机构，因为给了你一些药，就对他们自己的临床试验可能发生什么产生怀疑。
布莱克： 在医学上你会怎么解决这个问题？
马克斯： 这就有点行业内幕了。比如说，FDA 必须被禁止对不同使用者之间的衣壳（capsid）做出不利推断。只要阻止这种偏执左右我们的决策，就有一些具体的方法，可以用相对轻量的监管手段真正加速创新。
中国的 FDA 正在打败我们
吉列尔莫： 有没有比 FDA 更好的东西？我们该拿这些监管机构跟什么做基准比较？
纳瓦尔： 所有人都跟随 FDA。所有人都在模仿 FDA。
马克斯： 两个延伸。第一，欧洲——其实并不比 FDA 更好，但他们的体系不同。他们有这些公告机构（notified bodies）——基本上就是受东道国政府认可、获准认证东西的私营企业。火车、飞机、医疗设备。公告机构体系在审核层面创造了稍好一点的激励，因为他们可以雇人、可以扩张、存在竞争。他们自己也必须遵守东道国政府设定的条件，但这意味着他们可以比美国多出成千上万的审核员。
第二——今天确实有一个已获批、正在收费的植入式 BCI（脑机接口），它在中国。CFDA（中国国家药品监督管理局）在独立思考。他们的体系，我觉得如果我们不小心，会让我们吃不消。把一种药物或器械推向市场的成本要低得多。你可以直接在人体上试，直接在市场上试。
这是我花了大量时间思考的事情。二十年前，我们买的笔记本电脑和手机要少得多；每一台都贵得多。现在它们更便宜了，数量多得多，我们买得更多，总支出上升了。这很棒。高通、三星和苹果的股价大涨。人人都高兴。他们用手机和笔记本电脑创造出的超额财富，去买更多手机和笔记本电脑。
这在医疗领域不会发生。由于报销机制——这里发生的是企业级销售——我们用来购买医疗服务的资金池基本上是固定的。它不会像我们在技术增长行业看到的那样，随着越来越多东西带来更好的医疗结果而增加。医疗支出的增长速度大约等于税收收入的增长速度。如果 AI 蓬勃发展、出现重大进展，两年后我们在 AI 上的支出是现在的十倍，这可能很棒。但如果两年后我们在医疗上的支出是现在的十倍，那将是一场灾难。这从根本上与成为技术增长行业相矛盾。
医疗领域有一个包罗万象的问题，全都指向同一件事：把这些东西推向市场实在太贵了。这就是中国正在触及的核心。出路不是单一支付方制度，也不是对医疗保险做某种修补。而是降低成本，让某人可以用信用卡买下它，分期付款，最坏情况下也许就像买车一样——然后你在交易中向他收费。要做到这一点，我们必须让这些东西更便宜地推向市场。中国正在这么做。这将让他们能以 1 万美元而不是 10 万美元的价格出售这些东西。这就是放松监管。
医疗是资本主义内部的共产主义社会
纳瓦尔： 从根本上说，医疗领域没有私人市场。人们有时会打的比方是——想象一下，不是去餐馆吃饭并付钱，而是你到所有餐馆去吃饭，月底把所有收据和账单寄给你的保险公司或政府，由他们给你报销。那样的话，每家好餐馆门口都会排起长队。每家差餐馆都会有空位。等待会非常糟糕。产品不会改进。你基本上是在一个更大的资本主义社会内部，运营着一个小型共产主义社会。这就是我们在医疗领域做的事。
布莱克： 我们在公路上也是这么干的，这就是为什么会有交通拥堵。上高速没有动态定价，所以它总是堵。
纳瓦尔： 如果你愿意暂时踩一下医疗的"第三轨"，想想这个方案。告诉我它有什么问题。想象一下，你年收入的前 20% 就是你的医疗免赔额。如果你身无分文、无家可归，那就是零。如果你很有钱，那就是几百万美元。无论你的年收入是多少，前 20% 都是你的医疗免赔额。其余部分由政府保险体系支付，直到他们今天通常设定的上限。
你很快就能创造一个私人市场。在牙科、整形外科以及很多可选的医疗项目上，你会得到竞争的局面。你会得到改进。看看 LASIK 眼科手术。看看牙科的贴面、牙套和牙科手术。看看整形外科。这些领域似乎确实在进步，因为它们是私人付费——人们用钱投票。我们需要在常规医疗体系中做某种类似的事情。但人们会失去理智。他们甚至不愿多想一步。"不不不，那穷光蛋怎么办？"穷光蛋没有收入。"对有些人来说 20% 太多了。"好吧，你可以在里面放一些免赔额。但总的来说，如果没有某种私人市场，让人们自掏腰包支付医疗项目，你就永远得不到这个反馈回路。你就永远无法让更多的钱流入这个体系。
现在，非常富有的人可以自愿向体系里花钱。但价格表哪儿都没有。费率卡哪儿都没有。这个体系不是为此设计的。如果你去买医疗服务，想自费支付，有时候他们会报给你一个比保险公司付的高 10 倍的价格。
希德的故事：N-of-1 医学
马克斯： 你听说过希德（Sid）在 GitLab的故事吗？他完成了一次极为成功的 IPO，然后被诊断出患有一种罕见的癌症。他已经远远活过了预后预期。他真的把命运掌握在了自己手里。他做了前线化疗，然后有一种替代方案可用，他用尽了，医生们说："我们没什么可给你的了。"从那以后，六七家公司从中诞生。现在他的升级阶梯上有二三十种药物。他还活着。
吉列尔莫： 他状态很好。我前几天还见到他了。他基本上创造了自己的个性化医学和治疗方案。
马克斯： 我现在已经听过好几个这样的轶事了。我非常清楚，在高端——如果你不跟保险打交道，你有资源，你会说："我要现代科学的全部工具箱"——那么疯狂的结果是可能的。如果你去问你的医生："如果我这样做会怎么样？"他们会开始大喊大叫、乱扔东西。但在高端，疯狂的事情是可能的。这种 N-of-1 医学，最终将成为理解如何构建更可转化之物的极其丰富的研究素材。
吉列尔莫： 这要求病人在他们最虚弱的时刻爆发出巨大的主动性，这相当讽刺。我的朋友死于癌症，而他最不想做的事就是研究 N-of-1 医学——他正以周为单位走向死亡。这才是 AI 真正应该大放异彩的地方，把你在那种处境下真正能做的事情大众化。仅仅从知识层面——而不只是金钱层面——来看，能接触到这些的人如此之少，实在有点疯狂。
Part 3 of our four-part discussion with three frontier founders: Guillermo Rauch (Vercel), Blake Scholl (Boom Supersonic), and Max Hodak (Science Corp).
Also see Part 1: Waste Tokens, Save Time, Part 2: Vibe Coding Hardware, and Part 4: The Autonomous Company (coming soon).
The Regulatory Red Queen Race
Blake: One of the things we’ve seen related to regulatory — it massively reduces change aversion and improves iteration. Example: let’s say you’re going to certify an airplane. One of the zillions of things you have to do is prove it can withstand a lightning strike. The regulatory documentation for the test plan stretches on for, say, 200 pages. What you would classically do is hire a — let’s be honest — not super-bright engineer who’s willing to be there, monkey at keyboard, writing 200 pages of regulatory compliance documentation. It takes a couple of months. And by the way, if you change the airplane, now you want to cry, because there’s another two months of rework of this rote compliance documentation.
What we’ve found is we can build a RAG that will enable us to basically prompt our way through all of that work in — let’s call it minutes. The first-order effect is you save a lot of time. The second-order effect is, if you change the specification of the airplane, it now takes minutes, not months. So you can actually be willing to change. And the third-order effect is you can get rid of the not-very-great engineers and have a small number of really creative ones who can iterate rapidly, because the cost of change goes down. In a certain sense, the entire regulatory burden — which really hurts the ability to iterate — drops away.
Max: This is a really undersold story in AI right now. The consensus in Silicon Valley is that regulation sucks — we want to go faster, we want to realize this amazing future, we want abundance, prosperity, and stuff that slows down that future is to be avoided. Certainly we’ve over-regulated. We’ve made it impossible to build stuff. It’s totally crazy what goes into building any physical thing in a lot of places.
But a lot of the regulations themselves are not the problem. If you’ve actually read a lot of these things — having non-smog-choked cities is great. Being able to swim in many rivers is great. A lot of these things were progress. The problem is that it’s really difficult for humans to deal with understanding and complying with this, and every time you have to exchange a letter with the government, you wait months. If you could take a lot of the things we’ve learned and make them totally frictionless, that would be pretty cool. I think that’s an under-sold story.
Naval: Until the regulator starts spewing tokens back at us. Then you start getting huge amounts of documents from the regulators that you have to comply with, and it’s agent-on-agent wars. But at least it’s a fair fight.
Max: That’s basically what we have now.
Blake: I’d actually argue that would be an improvement from where we are now. One of the terrible things right now is, if you’re going to build anything physical, you have to get a building permit. You’re guilty until proven innocent. The worst thing we’ve run into is the fire department, because they have the moral imprimatur of people pulling people out of burning buildings — and yet what they actually do is just screw with your design for buildings for months. If we could replace the fire marshal with an agent that would critique your building plan quickly — even if its feedback were overdone — it would be massively better than the delays that exist today.
Guillermo: When Max was talking about this potentially being a good thing — that we have all this regulation — my head went to: the thing that makes agents successful is humans or other agents setting up the right testing guardrails. People are really excited about slash goal, or Ralph loops, where you tell the model, “Go do this, and this is your exit criteria.” I’m telling Blake, “Go make us all supersonic. Your exit criteria is that you’ve complied with all of these regulations.” There’s totally a world where we say the regulations are great — they’re like our test suite. As long as passing them doesn’t incur contradictions, and the regulations are actually reasonable, they’re an awesome guardrail. Otherwise we’d be shipping slop directly into the air.
Naval: This is going to turn into a Red Queen’s race. They’re going to have agents, we’re going to have agents. I think we might have better agents — that’s good, as opposed to human-versus-human. But their cycle time, their response time, may get longer. The App Store is drowning in spam right now. I’m sure the patent office is drowning in spam. These agencies are going to be slow adopters of AI. They’re going to get DDoSed by clever entrepreneurs just overloading them with documents. It’s possible the approval time for this stuff may extend out as it suddenly gets flooded.
Why There’s No Innovation in Healthcare
Blake: It creates an opportunity to really shift the regulatory model. Imagine if we drove around a city the way we build things today. Before you could go anywhere, you’d have to write a plan, ship it to some regulator, and wait. Your plan would have to specify, “We’re going to take such-and-such a route, drive this speed limit, use our blinker, stop at every stop sign, never run a red light,” blah blah blah. Three months later you get a critique back: “We think you should drive on this other street.” Eventually you get approval and you go drive somewhere. It’s insane — you can never go anywhere. And yet that is absolutely the way we build physical infrastructure in this country. We should actually make more of these things enforcement-based, rather than pre-approval-based.
Max: I don’t want to be under too much — if I ship a medical device to a lot of people, there needs to be — there are unknowns. We were responsible, we did clinical trials, we reported all the data, but —
Naval: Max, this is why there’s so little innovation in medical right now. The FDA approval process is a nightmare. In fact, the two biggest advancements in tech in Silicon Valley in the last decade — AI and, before that, crypto — they’re both in the math domain, because that’s the last unregulated domain. When they start regulating frontier models and start regulating GPUs, that stops as well. Peter Thiel laments that there’s no innovation in the physical domain. Well, it’s been held back by huge regulatory barriers.
You can always find a scary case — a vaccine, or a famous medical disaster — but the regulations spread everywhere, the tentacles are everywhere, and there are all these contradictory regulatory bodies. SpaceX got sued for not having enough — I forget what — migrants or refugees or whatever, but they’re not allowed to hire them, by government regulation on the other side, because they’re not citizens. This is not like logical code that has to compile in one place. These are made-up random regulations all over the place. You might comply with one state and violate another, violate federal over here, annoy this guy over here, that guy chooses to prosecute one out of fifty people who are his friend. It’s arbitrary. It’s capricious.
Blake: And the idea that this makes things safer is a complete mythology. Watch Boeing. They certified the 737 MAX, which had a single sensor that had complete authority over the nose-up, nose-down attitude of that airplane. No intern is dumb enough to think that’s a good idea. Yet it got all the way through the certification system. This stuff doesn’t actually make us safer, it just makes us slower.
Max: Well, there’s definitely dysfunction here. I think some of this makes us safer in the sense that the NRC makes us safer — which is that their job was to make sure nuclear energy was safe, and they did this by permitting zero plants from the seventies until I think a year ago. It will be perfectly safe if we never build any of it.
I want to be really clear — I’m on the side of deregulation on a lot of this. I agree with Blake that a lot of this can be done more efficiently. But I also think it’s a little too dismissive to say, “This is just the FDA, the agencies.” The problem is deeper. If the FDA approves ten really important drugs, they don’t get any credit. One patient dies, and they get hauled before Congress and yelled at. They have very negatively-biased incentives. The reality is that this is reflective of the beliefs of the American people. There’s a trade-off between the perception of risk taken in human-subjects research, and the rate at which we get new medicines.
Blake: It’s totally asymmetric. If you approve a bad thing, your career is over. If you block a good thing, nobody notices. It creates an asymmetric slowdown. I think that is the most important problem to solve in the regulatory state.
Max: This is a very deep problem because it is where the voters are. We poll some of the stuff we’re working on in the future to understand where the American people are on it. If you push too hard, you can work around it — go to Próspera, all kinds of ways to try to go faster. But if you’re seen as being a bad actor, you’re rejected from the society we live in. That’s the thing you need an answer for. That’s deeper than just saying, “We need regulatory reform.”
We Need a True 50-State Experiment
Naval: You have a deep point there, Max — it’s where the voters, the citizens, are. We like to blame politicians. You’ll see this on X all the time — people are like, “This politician, that politician, the other politician.” They’re elected, by majority vote. This is where the people literally are. That’s the package, that’s the bundle they’ve chosen. You may not like this instantiation, but if you removed this one, something very similar would take its place, because the voters would just vote them right back in.
Culturally it’s very hard for most people to understand what we lost, what we missed. France — there’s a French entrepreneur on X lamenting that 57% of GDP gets sucked up by the government, so you can’t create companies. But to the average French citizen, that’s not visible. They don’t notice what they’re missing. They just know they’re slightly poorer than the US. The Economist just did a little piece — economists are finally coming back around to being capitalists after thirty years — on how the US is outstripping everybody, growing faster, getting bigger. But they immediately turn around and say, “It’s because of the oceans, because of natural resources” — everything but capitalism. They don’t want to say the dirty C-word, because for some reason all these magazines became Marxists at some point. They can’t envision or imagine what could have been if we had just been a little more laissez-faire, a little more open.
I would love to see a true experiment among the fifty states. Different regulations, different tax structures. Right now federal tax structure and federal regulations dominate everything. But imagine you could go to some small state if you had cancer, and you could try every drug everyone was cooking up. Caveat emptor — you’ve got to do your research. This is known as the experimental zone. Same for drones. Same for aircraft — a little harder, because you’ve got to cross a lot of areas — but yeah.
Blake: There’s something magical in there — the notion of innovation zones. We have a huge NIMBY problem. But if you create opt-in YIMBY zones, they create that experimentation framework. By definition, it happens where people are consenting. You can try different rules, or no rules, or different ways of enforcing — innocent until proven guilty — and see what actually happens. What are the innovation consequences? What are the safety consequences? Then the successes can spread.
Max: To Naval’s point, an innovation zone would not solve the problem in drug discovery. The Right to Try Act passed a little while ago. We’ve had this pathway called Single Patient IND for a lot longer than that. If your doctor calls the FDA and says, “I want to give my patient an unapproved drug,” they approve over 99% of those. They can even grant them over the phone.
The problem is that to dose a patient you still need clinical-grade drug. The only entity with that is typically the IP owner who’s in the middle of running a clinical trial — they’re investing hundreds of millions of dollars into making this thing. The FDA will draw an adverse inference if something bad happens to your patient who’s probably really sick to begin with, and that’s seen as a property of the drug, which is global — not related to your innovation zone. So there are two problems. One, you need to get the IP owner to give you some of their drug — they’re not going to do that. Two, you need to prevent the global regulator from casting doubt on what might happen with their clinical trial if they give you some.
Blake: How would you address that in medicine?
Max: This is inside baseball. The FDA has to be prohibited from drawing adverse inferences across different users of a capsid, for example. There are specific ways you could really accelerate innovation with a relatively light regulatory touch by just preventing this paranoia from driving our decisions.
China’s FDA Is Beating Ours
Guillermo: Is there anything better than the FDA out there? What are we benchmarking these regulators against?
Naval: Everyone follows the FDA. Everyone copies the FDA.
Max: Two expansions. First, Europe — not really better than the FDA, but they have a different system. They’ve got these notified bodies — basically private businesses blessed by their host governments to certify things. Trains, planes, medical devices. The notified-body system creates slightly better incentives at the review layer because they can hire people, they can grow, there’s competition. They themselves have to be compliant with conditions placed by host governments, but it means there can be many thousands more reviewers than in the US.
Second — there actually is one approved, getting-paid implantable BCI today, which is in China. The CFDA is thinking for itself. They have a system that I think is going to give us a run for our money if we’re not careful. The costs to bring a drug or device to market are just much lower. You can try things in humans and try things on market.
Here’s the thing I’ve been spending a lot of time thinking about. Twenty years ago we were buying far fewer laptops and phones; each one was much more expensive. Now they’re cheaper, there are far more of them, we buy more of them, total spending has gone up. This is great. Stock prices of Qualcomm and Samsung and Apple are way up. Everybody’s happy. They’re using the excess wealth generated by phones and laptops to buy more phones and laptops.
This doesn’t happen in healthcare. Because of the reimbursement mechanism — there’s this enterprise sale happening — the bucket of money we use to buy healthcare is basically fixed. It is not increasing as there’s more stuff producing better healthcare outcomes, the way we see in technological growth industries. The rate of spending on healthcare grows at roughly the rate of growth of tax receipts. If AI is booming and there are major advances, and two years from now we’re spending ten times as much on AI, this could be great. But if in two years we’re spending ten times as much on healthcare, this would be a catastrophe. This is fundamentally at odds with being a technological growth industry.
There’s this omni-problem in healthcare, all related to the same thing: it’s just too expensive to bring these things to market. That’s what China is getting at. The way out of this is not single-payer or some revision to health insurance. It’s to bring down the costs so that someone can buy this with a credit card, finance it, maybe like a car, worst case — and then you charge them in the transaction. To do that, we have to make it cheaper to bring these things to market. China is doing that. That will allow them to sell these things for $10,000 instead of $100,000. That is deregulation.
Healthcare Is a Communist Society Inside Capitalism
Naval: Fundamentally, there’s no private market in healthcare. The analogy people make sometimes — imagine that instead of going to restaurants and paying, you’d go to all the restaurants, and at the end of the month you’d send all the receipts and bills to your insurer or to the government, and they would reimburse you. There’d be a line outside every good restaurant. Every bad restaurant would be available. The waits would be terrible. The product wouldn’t improve. You’re basically running a small communist society inside a larger capitalist society. That’s what we’re doing in healthcare.
Blake: It’s also what we’re doing on roads, which is why we have traffic. There’s no variable pricing for getting on the highway, which is why it’s always clogged.
Naval: If you want to step on the third rail of healthcare for a moment, think about this plan. Tell me what’s wrong with it. Imagine that the first 20% of your annual income was your healthcare deductible. If you’re broke and homeless, it’s zero. If you’re rich, it’s millions of dollars. Whatever your annual income is, the first 20% is your healthcare deductible. The rest is paid by the government and the insurance system, up to the usual caps they have today.
You’d create a private market pretty quickly. In dental, plastic surgery, a lot of optional medical procedures, you’d get a competitive situation. You get improvement. Look at optometry with LASIK. Look at dental with veneers and braces and dental surgery. Look at plastic surgery. Those fields do seem to be advancing because they’re private payers — people voting with their money. We need to do some equivalent of that in the normal healthcare system. But people lose their minds. They don’t even want to think one step ahead. “No, no, no, what about the broke person?” The broke person has no income. “Twenty percent is too much for some people.” Okay, you can put some deductible in there. But generally, if you don’t have some private market where people are paying out of pocket for what are medical procedures, you’re just not going to get this feedback loop. You’re not going to get this ability to spend more money into the system.
Right now, very wealthy people can spend voluntarily into the system. But the prices aren’t anywhere. The rate cards aren’t anywhere. The system’s not designed for it. If you go shopping for medical care and you want to pay out of pocket, sometimes they’ll quote you a price that’s 10x what they charge the insurance company.
Sid’s Story: N-of-1 Medicine
Max: Have you heard Sid’s story from GitLab? He had a massively successful IPO, then was diagnosed with a rare cancer. He has lived way past the prognosis. He really took it into his own hands. He did frontline chemo, then there was one alternative available, he exhausted it, and the doctors were like, “We’ve got nothing for you.” Since then, six or seven companies have come out of it. There are now twenty or thirty drugs in his escalation ladder. He’s still alive.
Guillermo: He’s doing great. I saw him the other day. He basically created his own personalized medicine and treatment plan.
Max: There are a handful of these anecdotes I’ve heard now. It is really clear to me that at the high end — if you’re not dealing with insurance, you have the resources, you’re like, “I want the full toolbox of modern science” — outcomes are possible that are crazy. If you go ask your doctor, “What will happen if I do this?” they will start shouting and throwing things. But crazy things are possible at the high end. This type of N-of-1 medicine is going to end up being a really rich source of research for understanding how to build more translatable things.
Guillermo: It requires a ton of agency from the patient in a moment where they’re at their weakest, which is pretty ironic. My friend passed away from cancer, and the last thing he wanted to do was research N-of-1 medicine — he was dying by the week. This is where AI should really shine, and democratize what you can actually do when you find yourself in that situation. It’s kind of crazy how few people get access to this, just from a knowledge perspective, not just monetarily.