我们能信任FDA吗？马蒂·马卡里谈科学、权力与患者

这是特朗普总统在第一个任期内取得的非凡成就。

It's an amazing achievement of President Trump in his first term.

我已签署了我的办公桌上收到的全部右试用请求。

And I have signed 100% of Right to Try requests that come across my desk.

当然，公司必须同意提供药物，但这是一个很棒的项目，我们不希望人们被无效的‘蛇油’骗了，那些东西花费高达300万美元，而他们的教会还在发起GoFundMe筹款，而我们知道这种药物根本无效。

Of course, the companies have to agree to make the medication available, But it's a great program, and we don't want people getting spun up on snake oil that doesn't work, that's cost $3,000,000 where their churches are doing GoFundMe campaigns, when we know a drug does not work.

因此，我们有责任，必须好好管理医疗保险项目。

So we do have a responsibility, and we have to be good stewards of the Medicare program.

他们正在用纳税人的钱来资助这些事情。

They're using taxpayer dollars to fund things.

但如果某种药物显示出疗效，而有人想尝试，我们有什么权利说不行呢？

But if there's a signal that something works and somebody wants to try a drug, who are we to say you can't?

所以我们关注安全性，但在安全性之外，我们必须在监管上尽可能灵活。

So we look at safety, but beyond safety, we have to be as flexible as possible with our regulation.

就在本周，我们宣布取消了一些细胞和基因疗法的监管要求。

And we announced just this week that we are getting rid of the, some of the regulatory requirements for cell and gene therapy.

这些疗法主要用于许多罕见疾病，但我们之前有要求，即所谓的PPQ批次运行，这是细胞和基因疗法制造要求的一部分。

Now those are used for a lot of rare diseases, but we had requirements, what we call PPQ runs for batches of, it's part of the manufacturing requirements for cell and gene therapies.

我们一直用与大规模生产药片相同的高标准来要求它们。

We were holding them to the same standards we were for, say, mass manufacturing of a pill.

然而，细胞或基因疗法可以在加州大学旧金山分校或斯坦福大学的实验室中开发出来。

Well, a cell or gene therapy can be developed in a lab at UCSF or Stanford.

当您拥有一个成熟的科学平台、一个有效的载体平台，并且只是在人体基因组的不同位置进行手术时，我们真的需要要求它们使用相同的广泛制造标准来生产多个批次吗？

And are we going to require that they use the same manufacturing broad standards to do multiple batches when you've got a scientific platform that works, a vector platform that works, and you're basically doing surgery on the human genome just in different locations?

因此，我们本周早些时候发布了这一公告。

So we made that announcement earlier this week.

所以让我来理解一下这一点。

So let me just understand that one.

我在这个领域已经花了一些时间。

I've I've spent a little time in this space.

这意味着我不再需要通过GMP（良好生产规范）设施，就能将这些疗法推广给更广泛的患者吗？

Does this mean that I will not need to go through a GMP or good manufacturing practice facility to bring those therapeutics to a broader set of patients?

而且，这是否意味着一旦我有了一个有效的系统，就可以用它来治疗不同的适应症？

And does it also mean that once I've got a system that works, I can use it for different indications?

也许你能稍微解释一下这将走向何方，因为如今有许多患者正在查阅细胞和基因疗法的论文和早期数据，他们想知道：我什么时候能获得这些治疗？

And maybe help understand a little bit about where this goes because there's many patients that today are looking at papers on cell and gene therapies, early data, and they're saying, when can I get access?

我有风险。

I'm at risk.

这对患者来说至关重要，也许你能说明一下这如何转化为更快的治疗速度和可及性。

This matters a lot to patients, and maybe you can help contextualize how this translates into speed and access.

是的，我们周日发布的公告是，将根据药物本身和所治疗的人群来定制制造要求。

Yeah, so the announcement that we made on Sunday was that we're gonna customize the manufacturing requirements to the drug and the population being treated.

因此，存在多种灵活性，包括你提到的那些，但不再强制要求必须以这种方式操作。

So there's a number of flexibilities, including the ones you mentioned, but it's no longer gonna be this hard and fast, you have to do it this way.

例如，之前要求的三批生产。

For example, the three batch runs that have been required.

这些原料价格昂贵。

Those ingredients are expensive.

我的意思是，仅仅一种成分的成本就可能高达十万美元。

I mean, ingredients could cost a $100,000 for just one ingredient.

所以我们必须运用常识。

And so we have to use common sense.

我的意思是，当你亲眼看到某种疗法在孩子身上产生神奇的效果，而他们却没有任何帮助时，你难道不会问，我们为什么还要阻碍它呢？

I mean, when you see something perform, you know, something magical to a kid with no help right in front of your eyes, you've got to say, like, what are we doing getting in the way?

在我们早期阶段，有个叫KJ的婴儿出院回家了，对吧？

We just had, early in our time there, baby KJ go home from the hospital, right?

这个婴儿接受了基因编辑治疗。

So this infant got gene editing therapy.

你不可能对这种情况进行随机对照试验。

You can't do a randomized trial on that.

患这种病的孩子太少了。

There's not enough kids who have it.

因此，对于这些个性化疗法，我们实际上为它们创建了一条全新的路径。

So these bespoke therapies, we created essentially a novel pathway for them.

医生。

Doctor.

维奈·普拉萨德在《新英格兰医学杂志》上描述了这一点。

Vinay Prasad described it in the New England Journal of Medicine.

这被称为可信机制路径，本质上是将黄金标准科学与常识相结合。

It's called the plausible mechanism pathway, and it's basically combining gold standard science with common sense.

对，那CAR-T疗法呢？

Right, and what about for CAR T therapies?

CAR-T疗法正涌现出一类新的治疗手段，历史上一直仅用于肿瘤学和癌症治疗，现在越来越多地讨论将其用于自身免疫性疾病。

So there's this blossoming class of therapeutics in CAR T that's historically been used exclusively for oncology, for cancer, increasing discussion about using it for autoimmune conditions.

这有助于推动CAR-T疗法的路径，实现更快上市、更多可及性和更低成本吗？

Does this help with the CAR T therapy pathway and enabling faster routes to market and more access and lower cost?

可以。

It can.

顺便说一句，CAR-T疗法非常出色。

And by the way, CAR T is amazing.

CAR-T疗法太神奇了。

CAR T is amazing.

我不是来推广某一种疗法的，但它们确实令人惊叹。

I'm not here to promote any one class of It is amazing.

但我们所看到的这些成果简直令人难以置信。

But I mean, the stuff that we have seen is mind boggling.

是的。

So yes.

为了让人们理解，当他们取出T细胞、进行编辑后再回输到体内时，这些T细胞会攻击体内的目标并摧毁它们。

And just for folks to understand, when they take T cells, edit them, and put them back in the body, those T cells go after targets in the body and destroy those targets.

许多血液癌症现在在接受CAR-T疗法后取得了非凡的疗效，现在它们正开始用于自身免疫性疾病。

And many blood cancers are now seeing extraordinary results with these CAR T therapies, now they're going after autoimmune conditions.

但显然，我们需要更快的上市路径、更低的成本，因为目前的定价仍然高达50万到100万美元。

But it definitely seems to be that there needs to be a faster path to market lower cost because the pricing is half 1,000,000 to $1,000,000 still.

是的。

Yeah.

这太神奇了。

It's amazing.

我们本质上是在激活你自身的免疫细胞，让它们明确地识别并靶向你体内需要被清除的目标。

We're essentially activating your own immune cells to to have a a very clear path and target something in your body that needs to be targeted.

我们现在发现，在拜登政府时期，曾批准将美国患者的细胞运往中国，由中国方面进行基因编辑，然后再运回美国，回输给美国患者。

It's now we did find that there was, in the Biden administration, approval to have the cells of Americans for CAR T therapy shipped to China where the Chinese did the gene editing and then shipped back to The United States to infuse in Americans.

当我得知这件事时，我们立即叫停了这一做法。

When I found out about that, we shut that thing down so fast.

哇。

Wow.

是的。

Yeah.

所以我们必须谨慎行事。

So we have to do things carefully.

自从你进入FDA以来，你还发现了什么？没有。

What else have you discovered since you've been in the FDA that No.

震惊，天哪。

Shocked Oh, man.

很多。

A lot.

先别急，稍等一下。

Just go on and aside for a second.

我很好奇，你发现的最大震惊是什么？

I'm I'm curious to know what are the biggest shocks that you've uncovered.

我的意思是，你已经在那儿待了一段时间了。

I mean, you've now been there for some time.

你之前提到，我们坐下来之前，你正在数字化数百万份文件，是的。

You mentioned before we sat down that you're actively digitizing millions of files Yeah.

这些文件历史上一直未被数字化。

That historically have not been digitized.

我假设你现在可以使用人工智能和其他工具快速阅读这些文件。

And I'm I'm assuming you can now use AI and other tools to go read through them very quickly.

对你来说，什么最令人震惊？

What's been shocking to you?

我从哪儿说起呢？

Where do I start?

嗯。

Yeah.

有人把一个装着药物档案的箱子从一栋楼搬到另一栋楼。

I mean, somebody was carrying a box from one building to another building with with a drug file in it.

结果律师说，他们不能通过电子邮件把信息发到另一个中心，因为在我们到达之前，每个中心都像是各自独立的秘密政府。

And it turns out that the lawyers said they couldn't email the information to the other center because, you know, each center was like their own secret government before we got there.

FDA的每个中心？

Each center of the FDA?

FDA的每个中心。

Each center of the FDA.

同一个机构。

Same agency.

是的。

Yeah.

同一个机构。

Same agency.

七个中心。

Seven centers.

就像，你知道的，他们各自有界限、领地，还有自己的律师。

It was like, you know, they had their own boundaries territories and, you know, lawyers.

他们各自有沟通团队，发布自己的公告、新闻稿，处理自己的立法事务，还要安排自己的听证会。

They had their own communications staff put out their own releases, their own press releases, did their own legislative affairs with had to schedule their own hearings.

有时局长都不知情。

And the commissioner was out of the loop sometimes.

所以我们重新整合了整个机构。

And so we restructured the entire agency now.

我们将这些服务集中起来了。

We centralized those services.

但在这种机构各自为政的时代，对于那些拥有药物-器械组合产品的企业来说，这简直是一场噩梦。

But in the days of this sort of siloed world of the agency, and by the way, was a nightmare for developers that had a drug device combination.

我的意思是，各个中心之间的管辖范围划分就像被人为操纵的选区一样，完全取决于内部争斗。

I mean, it was like gerrymandered lines of what was included in one center versus another center based on infighting.

而且，你知道，那些人已经在那儿干了很久。

And, you know, people had served long terms there.

他们就像津巴布韦的穆加贝总统一样，一直在那儿待了整整一辈子。

You know, they'd served terms like president Mugabe of Zimbabwe who'd been there, you know, forever.

这些人就是一直在那儿，待了整整一辈子。

These people just were there forever.

对吧？

Right?

这根本就是他们的行事方式。

It was just their way.

每当领导层出现空缺时，二十次里有十九次都会提拔内部候选人。

And anytime there was an opening in leadership, 19 times out of 20, it went to an internal candidate.

所以你并没有太多新鲜的想法。

So you didn't have a lot of fresh new ideas.

我们现在有很多充满活力的新科学家加入。

We have a lot of a lot of fresh scientists coming there.

我提到过那1000名新科学家。

I mentioned the 1,000 new scientists.

我们目前正在入职450名新科学家。

We're we're onboarding right now, 450 of them.

其中50人已经刚刚开始工作。

50 of them already just started.

但我认识一个人，他的工作就是给一台传真机更换墨盒。

But, I've met a guy who, his job was to change the ink cartridge on a fax machine, on one fax machine.

医疗保健行业单枪匹马地维持了传真机产业的生存。

Like, health care has single handedly kept the fax industry alive.

哇。

Wow.

那人的工作就是给传真机换墨盒？

The guy's job was the ink guy on the fax machine?

只是更换一下

Just to swap out

墨盒。

the ink cartridge.

传真机，换墨的人。

The fact machine, ink guy.

是啊。

Yeah.

这种事很多。

There's a lot of that.

这种事很多。

There's a lot of that.

好吧，我们转到食物的话题。

Well, let's shift over to food.

也许我可以给你一点时间，谈谈上周公告中你对食物金字塔所做的修改。

Maybe I'll just give you a moment to share what you changed in the food pyramid in the announcement last week.

你为什么做出这些改变？为什么以前没有做出这些改变？

Why you made those changes and why weren't they made before?

是的。

Yeah.

几十年来，医学界的教条和腐败造就了毫无意义的食物金字塔。

So we have had decades of medical dogma and corruption putting together food pyramids that make no sense.

人们其实都看得出来，这其实是个公开的秘密——它们毫无道理。

People can tell, I mean, the open secret was that they make no sense.

它们在科学上是不准确的。

They're scientifically inaccurate.

而且这些金字塔常常是由食品行业，或食品行业对学术界的影响所主导制定的。

And they were oftentimes curated by the food industry or the food industry's influence on academia.

营养科学可能是整个科学领域中最腐败的领域之一。

Nutrition science may be one of the most corrupted fields in all of science.

这导致了我们不得不专注于饱和脂肪，并从美国食品供应中彻底消除天然健康脂肪，却忽视了用精制碳水化合物替代脂肪的做法其实并不健康。

And it gave us the dogma that we had to focus on saturated fat and just eradicating natural healthy fats from The US food supply, ignoring that you replace fats with refined carbohydrates, which are not healthy.

如今，美国儿童的饮食已经高度依赖碳水化合物。

And we have this carbohydrate heavy diet now for American children.

你猜怎么着？

And guess what?

百分之三十八的儿童患有前期糖尿病或糖尿病。

Thirty eight percent of kids have prediabetes or diabetes.

这很意外吗？

Is that a surprise?

这一上升趋势与从饱和脂肪或普通食物转向大量摄入精制碳水化合物和添加糖的变化完全同步。

The rise has paralleled the shift from saturated fat or regular food to pumping refined carbohydrates and added sugar.

如今，美国儿童每日摄入的热量中，有60%到70%来自精制碳水化合物。

60 to 70% of the calories of a child in America today are refined carbohydrates.

却没有人谈论过这个问题。

No one has talked about it.

这一直被医学界忽视，因为他们对饱和脂肪这个‘罪魁祸首’有着狭隘的专注。

It's been in a blind spot as the medical establishment has had this myopic focus on the boogeyman of saturated fat.

因此，我们曾经有一个完全颠倒的膳食金字塔，而我们用科学依据将其倒置，关注之前被忽略的营养领域——即蛋白质的重要性。

And so we had a food pyramid that was entirely backwards, and so we flipped it upside down using good science, talking about previously ignored area of nutrition, and that is the importance of protein.

我们摄入的蛋白质只有所需量的一半。

We've been getting about half the protein that we need.

以往膳食指南中的蛋白质水平仅仅是为了防止身体衰弱。

The protein levels in the previous dietary guidance was really just to prevent withering away.

我们希望美国的孩子们能够茁壮成长。

We want our American kids to thrive.

看看今天孩子们的状况吧。

And look at the status of kids today.

蛋白质摄入不足，肌肉流失、虚弱、学业表现不佳，同时摄入大量精制碳水化合物和添加糖，导致他们陷入一种糖分引起的昏沉状态，即‘食物昏迷’。

Low in protein, muscle wasting weakness, underperforming in school, high in refined carbohydrates and added sugar, giving them that kind of sugar sort of coma, food coma.

在摄入精制碳水化合物的早餐后，我们下午又再次重重打击他们。

After a refined carbohydrate breakfast, again, we hit them hard in the afternoon.

他们几乎没有或完全没有自然光照。

They get very little or no natural light exposure.

他们被要求一整天七小时静坐不动，这根本做不到。

They're told to sit at a desk still for seven hours a day, they can't do it.

我们可悲地做了什么？

And what do we do tragically?

我们大规模地给全国的孩子们用药。

We have drugged our nation's kids at scale.

这是错误的，必须停止，我们必须重新审视根本原因，因此将这个食物金字塔倒置，关注蛋白质，是第一步。

It's wrong, it needs to stop, we have to reexamine the root causes, and so flipping this food pyramid upside down, focusing on protein, is the first step.

因此，我对我们的成就感到非常自豪。

And so I'm very proud of what we were able to do.

你现在进入了这个组织内部，能看到与旧食物金字塔长期构建和维持相关的文件，关于其背后的动机和参与制定这个食物金字塔的人，你发现了什么？

What have you uncovered now that you've been inside the organization and you can see paperwork related to the legacy of how the old food pyramid was constructed and maintained for so long about the motivations, who was involved in setting that food pyramid.

当你提到营养科学的腐败时，帮我们理解其根源所在。

When you mentioned the corruption of nutrition science, help us understand the root of that.

所以我上任前写了一本书，有机会深入研究并做一些调查性报道，了解我们是如何如此严重地误解了饮食准则的。

So I wrote a book just before coming into office where I had a chance to do a deep dive and do some investigative journalism, if you will, to learn how this dogma of what to eat got, we got so wrong.

我认为这很大程度上是群体思维，就像我们曾错误地认为阿片类药物不会成瘾一样。

And I think it was a lot of group think, just like we saw with opioids are not addictive.

医学界在这方面错误了整整十五年。

Medical establishment got that wrong for fifteen years.

儿童应在三岁前避免食用花生酱。

Young kids should avoid peanut butter until they turn three.

我们在这方面错误了整整十六年，后果惨重，引发了现代花生过敏流行，因为婴儿期接触花生酱能促进免疫耐受，从而降低花生过敏的风险。

We got that wrong for sixteen years, tragically wrong, igniting the modern day peanut allergy epidemic because peanut butter exposure in infancy reduces, there's something called immune tolerance, right, and it reduces the risk of peanut allergies lately.

我们是世界上唯一一个花生过敏率很高的国家，英国和少数其他欧洲国家也因采纳了我们建议的‘三岁前避免食用花生酱’这一教条而陷入同样的误区。

We're the only country in the world that has high rates of peanut allergies along with UK and a few other European countries that fell for our dogma based recommendation to avoid peanut butter till the kid turns three.

所以我们完全搞反了。

And so we got that 180 degrees wrong.

医学领域中存在一些教条，一旦形成便自我延续，人们甚至不允许质疑它们。

And so there are dogmas in the medical field that take on a life of their own, and you're not allowed to question them.

我们在新冠期间也看到了一点点这种情况。

And we saw a little bit of it during COVID.

如果你承认自然免疫的有效性，明白拥有新冠循环抗体的人可能不需要被解雇，但这些抗体却不被政府认可，这种教条就会自行其是。

If you recognize natural immunity and may not need to be fired from your job because you have circulating antibodies to COVID, but they were just antibodies that the government did not recognize, this dogma can take on a life of its own.

因此，我们正努力回归黄金标准的客观科学。

And so we're trying to get back to gold standard objective science.

科学的基本前提是你提出一个问题，然后检验是否存在一种答案或另一种答案，这简直太疯狂了。

It is crazy that the fundamental premise of science is you ask a question and then you test whether there's one answer or another.

从我的角度来看，如果连提问都不被允许，那就不是科学。

And the idea that you can't ask questions indicates that it's not science from my point of view.

所有标准都应该是可以被质疑的。

All standards should be challengeable.

你应该能够提出问题。

They you should be able to ask the questions.

从根本上说，如果它们经得起考验、站得住脚，那当然很好。

And, fundamentally, if they they hold truth or they hold ground, then great.

让我们保持它们。

Let's maintain them.

如果它们不行，我们就应该能够改变。

And if they don't, we should be able to change.

然后他们用‘科学’这个词，或者历史上，‘科学’这个词曾被用来证明不测试某些东西是合理的。

And then they use the word science or historically, word science has been then used to justify not testing something.

没错。

That's right.

这对我来说太疯狂了。

It's it's crazy to me.

食品公司在其中扮演了什么角色？

What are the roles that food companies have played?

那些在经济上希望维持原有膳食金字塔的人，历史上在这件事中扮演了什么角色？

What are the roles that folks that might have an economic incentive in keeping the food pyramid as it was played historically in this?

这一点现在是否已经永久改变了，还是只是在本届政府期间发生了变化，下一届政府又会再改回去？

And is that permanently changed at this point, or is it changed while this administration is here and it's gonna change again next cycle?

帮我们理解一下，工业界在影响这一监管过程中的作用是什么。

Help us understand a little bit about, you know, the the role that industry has in influencing some of this regulatory process.

我认为，工业界只是按照医学界的要求行事，即应对大规模饥荒的风险，解决粮食不安全问题，并认为无论热量来自何处，摄入的热量都等于消耗的热量。

Well, think the industry did what the medical field told them to do, and that is to address the risk of mass starvation and deal with food insecurity, and that calories in equals calories out, regardless of where those calories come from.

这就是当时的教条，也是对食品工业的指令。

That was the dogma and sort of the mandate to the food industry.

因此，他们照做了。

So they did what they were told to do.

于是他们转向了精制碳水化合物。

And so they moved to refined carbohydrates.

他们去除了谷物中的纤维，以便大规模生产。

They stripped the grains of fiber to mass produce them.

他们甚至把谷物切碎，这提高了它们的血糖指数，也就是说，它们的作用基本就像糖一样。

They would even chop them up, which made them increase your glycemic index, that is, it basically function like sugar.

因此，你的麦片、面包、意大利面都在像糖一样发挥作用。

So you have cereals, breads, pastas functioning like sugar.

于是我们迎来了一代孩子，你和我就是这一代的首批成员，是人类历史上第一代日常生活中经历着持续剧烈胰岛素波动的人。

And so we ushered in a generation of kids, and you and I were the first part of this, the first generation in human history with massive insulin spikes day to day in our normal everyday life.

我们从未见过如此程度的胰岛素波动。

We've never seen insulin spikes to that degree.

而这自然会导致一种叫做胰岛素抵抗的现象。

And of course that drives something called insulin resistance.

也就是说，你体内执行重要功能的器官试图阻挡这些过多的葡萄糖。

That is the organs in your body that do important functions are trying to block out all this extra glucose.

因此，它们改变了胰岛素受体的结构，以抵抗源源不断涌入的糖分。

And so they kind of change the configuration of the insulin receptor to just try to resist all this sugar coming in.

而胰岛素抵抗正是几乎所有慢性疾病的根源。

And it is at the root of almost every chronic disease.

胰岛素抵抗、全身性炎症——这些话题我们却从不谈论，从不。

Insulin resistance, general body inflammation, and we never talk about these things, never.

因此，我们在新的指南中将这些问题放在了最核心的位置。

So we talked about them front and center in our new guidance.

谷物的种类很重要。

The types of grains matter.

并不是热量摄入等于热量消耗。

It's not calories in equals calories out.

也不是说你只要在跑步机上运动一定时间，就可以吃这些东西。

It's not you can have this if you sit on the treadmill for this amount of minutes.

我们必须讨论食物所源自的土壤、养殖动物产品的 farming 技术、海鲜所来自的洁净无化学污染的水域，以及蛋白质的重要性、全谷物的价值，还有我们所说的真正食物。

We've gotta talk about the soil that food comes from and the farming techniques that, animal products come from and the cleanliness and chemical free waters that seafood comes from and the importance of protein, and the value of whole grains, and what we call real food.

因此，这个网站是 realfood.gov。

And so the website is realfood.gov.

我唯一的批评是金字塔顶端缺乏植物性蛋白质，作为素食者，我吃鸡蛋和乳制品。

My only criticism is the lack of vegetarian protein in the top of the pyramid where as a vegetarian, I eat eggs and dairy.

金字塔顶端可以再增加一些坚果和豆类，

It could use a few more nuts and beans up top,

但没错。

but Yes.

你知道的。

You know.

所以它可以。

So it could.

我会跟乔·杰比亚谈谈这件事。

I'll talk to Joe Gebbia about it.

它可以。

It could.

嗯。

Yeah.

不。

No.

它可以。

It could.

我认为《纽约时报》对蓝莓的事儿炸锅了。

I I think the New York Times had a conniption about blue the blueberries.

蓝莓？

The blueberries?

我觉得这反应 disproportionate 地过于激烈了。

I think it was disproportionately disturbingly large.

这就是批评吗？

That was the criticism?

是的。

Yeah.

好吧。

Okay.

这并没有让我感到困扰。

That wasn't one that bothered me.

我们来谈谈成年人口吧。

Let's talk about the the adult population.

我认为，根据不同的衡量标准，这个国家有百分之四十到六十的人属于肥胖，即临床肥胖。

I think forty to sixty percent depending on how you measure it are obese, clinically obese in this country.

这些肠促胰素模拟物，如GLP-1药物及其他类似药物，已经席卷市场，也深刻影响了我们的民众。

And these incretin mimetics GLP one drugs and others have really taken the market by storm, taken our population by storm.

因此，我意识到，这一切很大程度上是对我们国家正在面临的肥胖流行病的回应。

So I realized that much of this is in response to an obesity epidemic that we're facing in this country.

但事实证明，这些肠促胰素模拟物可能还具有其他系统性益处，目前我认为它们正在被测试用于多达60种适应症，包括肾脏、神经和心脏疾病。

But it turns out that these incretin mimetics may actually have other systemic benefits, and they're now I think there's 60 indications that they're being tested against, including kidney, neurological, cardiac.

我的意思是，这些药物在治疗其他疾病方面似乎潜力巨大。

I mean, there's there seems to be a lot of benefit potentially in using them for other disease indications.

你能谈谈你对这个市场、这类疗法未来走向的看法吗？

Can you speak a little bit about your view on where this market, where this class of therapeutics is headed?

有人预测，美国有百分之六十的人口最终会使用这些药物，这是真的吗？

Is this something that some people have estimated are sixty percent of Americans are gonna be on?

如果真是这样，那是否意味着我们的食品体系彻底失败了？

And if it is the case, does that mean we failed with our food system?

首先，我们的食品体系确实已经失败了。

Well, of all, we have failed with our food system.

看看美国百分之四十的孩子患有慢性疾病这一事实。

Look at the fact that forty percent of American kids have a chronic disease.

在医学教科书和医学院的字里行间，某种程度上是在责怪孩子缺乏自律。

Between the lines in the medical textbooks and medical school was kind of a blaming of children for not having the discipline.

这并不是意志力的问题。

And it's not a willpower problem.

这些高度成瘾的、经过化学加工的超加工食品被摆在孩子们面前，他们想要更多。

This is highly addictive, chemicalized foods that are ultra processed, that are put in front of kids, and they want more.

你还在这些食品中加入了来自石油基的鲜艳色素。

And you put these vibrant colors in them from the petroleum based dyes.

所以，这是成年人对孩子们做的事情。

And so this is something adults have done to kids.

因此，我认为我们失败了。

And so I think that we have failed.

我们给了人们错误的信息。

We've given people the wrong information.

热量摄入等于热量消耗，以及我们之前讨论过的对脂肪的妖魔化等问题。

The calories in equals calories out, this demonization of fat and all that stuff we've talked about.

GLP-1类药物模拟了人体内的一种天然激素。

GLP-1s are mimicking a natural hormone in the body.

因此，当你补充这种激素时，它能增加饱腹感、减缓胃肠道蠕动，并对多种疾病产生深远影响，因为你同时降低了胰岛素抵抗和全身性炎症。

And so when you get a supplementation of that, it's doing the job of increasing satiety, slowing down GI motility, and it has a profound impact on a number of conditions because you are also reducing insulin resistance and general body inflammation.

因此，我们看到了这么多其他益处。

And so that's why we're seeing so many other benefits.

而且你会感觉更好。

Plus you feel better.

当你感觉更好时，你会获得一些我们尚未充分认识的益处，因为这种积极心态具有巨大的价值。

When you feel better, you're going to have benefits you don't even, we haven't even appreciated yet because there's an incredible value, this sort of positive thinking.

我们在麻省总医院进行的乳腺癌和肺癌研究中已经看到了这一点。

We've seen it in a breast, in a lung cancer study from Mass General.

他们将患者随机分为姑息支持组和化疗组，结果姑息支持组的效果更好，尽管化疗药物比标准治疗更有效。

They've randomized people to palliative support versus chemotherapy, and the palliative support did better even though the chemo drug is more effective than standard of care.

所以你能看到这种巨大的价值，这种积极的思维，也许这正是我们看到成瘾率下降的原因之一。

So you see this incredible value, this sort of positive thinking, and maybe that's one of the reasons we're seeing reductions in addiction.

也许我们正在看到心脏方面的益处。

Maybe we're, you know, we're seeing cardiac benefits.

所以我们拭目以待。

So we'll see.

我的意思是，作为监管者，我们是裁判，希望看到产品能够快速且安全地上市。

I mean, we're, you know, as a regulator, we're a referee and we want to see products come to market quickly and safely.

但我认为我们现在正处在一个非常有趣的时期。

But I think we're at a pretty interesting time.

是的。

Yeah.

回到中国的问题上，因为我们之前讨论过关于速度的竞争优势，但我想再谈一下研究资金的问题。

Just to go back on the China point, because we did talk about competitiveness with respect to speed, but the other piece I wanted to address was funding of research.

所以我提到的生物技术委员会建议紧急投入150亿美元用于研究。

So that that biotechnology council I mentioned recommended a $15,000,000,000 kind of rushed investment in in research.

当我与科学家们会面时，有一种观点认为，特朗普政府反科学，正在削减美国许多本可挽救生命、开发惊人疗法的研究机构的资金。

When I meet with scientists, there's a view that the Trump administration is anti science, is defunding a lot of research institutions in The United States that are gonna save people's lives and develop amazing cures.

他们为什么要这么做？

Why are they doing this?

有一个委员会建议，即使面对中国，也应投入巨额资金支持科研人员，以开发下一代分子或治疗方式，从而改变并改善人们的生活。

There's this council that recommends that even in the face of China, they're putting out tremendous funding to support research scientists coming up with those next set of molecules or therapeutic modalities that are gonna change lives and improve lives.

也许你可以谈谈，我们政府对科学研究的资助是否足够？

Maybe you can comment a little bit on, are we funding through the government enough scientific research?

我们应有的稳定状态是什么？我们该如何应对特朗普政府反科学的这种说法？

What's the right steady state for us, and how do we address the the points about the Trump administration being anti science?

是的。

Yeah.

嗯，我们现在处于一个高度党派化的时代，人们被卷入了有毒的极化氛围中。

Well, look, we live in, partisan times now where people get spun up in their in sort of a toxic polarization.

事实上，若要了解真相，特朗普政府并未削减任何国家卫生研究院（NIH）的资金。

And the truth is, if we wanna know the facts, is that in the Trump administration, we have not cut $1 of n a I NIH funding.

我们没有削减任何 Medicaid 预算，那是整体的 Medicaid 资金。

We have not cut $1 to the general Medicaid budget, that is the overall Medicaid fund.

未来提案是将 Medicaid 增加 2000 亿美元。

And the proposal for the future is to increase Medicaid by $200,000,000,000.

所以你经常听到有人说，特朗普削减了 Medicaid，特朗普削减了 NIH。

So you hear all the time, oh, Trump cut Medicaid, Trump cut the NIH.

不对。

No.

我们希望看到的是，将 NIH 的资金从仅用于化疗和质子束疗法，重新分配到研究食物即药物、学校午餐计划、微生物组和肠道健康上。

What we wanna see is reallocating money at the NIH from just chemotherapy and proton beam therapy work to study food as medicine and school lunch programs and the microbiome and gut health.

我们必须开始讨论学校午餐计划，而不是把每个六岁孩子都用上 Ozempic。

We've got to start talking about school lunch programs, not just putting every six year old on Ozempic.

我们必须讨论睡眠质量，因为睡眠不佳是导致高血压的原因，而不是一味地给人开降压药。

We've got to talk about the quality of sleep as it is a cause of high blood pressure when you sleep poorly instead of just throwing people on antihypertensive medications.

我们必须讨论导致癌症的环境暴露因素，而不仅仅是治疗癌症的化疗。

We've got to talk about environmental exposures that cause cancer, not just the chemo to treat it.

因此，我们希望资金能投入到疾病的根源上。

And so we want to see funding go to root causes of diseases.

不幸的是，这一点一直被忽视，因为美国国立卫生研究院的文化长期以来都是弗朗西斯·柯林斯、托尼·福奇及其团队的文化——我这里简化一下，他们认为基因是我们健康问题的根源，基因也能解决我们所有的健康问题。

And that is something that has been unfortunately in a blind spot because the culture of the NIH is the culture of Francis Collins and Tony Fauci and the group for the last fifty years that, and I'm gonna oversimplify it, the gene is responsible for our health problems, and the gene can solve all of our health problems.

我相信基因疗法，我们在这一领域取得了惊人的进展，但为什么今天六分之一的女孩会患上自身免疫性疾病，对此的研究在哪里？

Well, I believe in gene therapy, we're doing amazing stuff with that, but where's the research on why one in six girls today will develop an autoimmune disease?

是什么引发了这种抗体反应？

What's triggering that antibody response?

孩子一生中接触到的众多环境因素中，究竟是哪些导致了他们身体的异常反应？

What of the many exposures in the life of a child is causing their bodies to be triggered?

这些研究是可以开展的。

These studies can be done.

要模拟参与1型糖尿病或多发性硬化症的抗体，并将其与环境中的暴露因素进行关联，以判断是否触发了相同的抗体结合构型，并不困难。

It's not that difficult to model the antibody that's involved in type one diabetes or MS and exposures in the environment to see if it is triggering that same configuration that the antibody binds to.

但没有人对此感兴趣，因为一切都集中在开发治疗方法上，而我们却必须关注病因。

But no one's been interested in it because everything has been about coming up with a, you know, treatment when we have to look at causes.

对。

Right.

而一线的科学家们看到他们的资金被削减。

And the scientists on the ground see their funding go away.

他们抱怨。

They complain.

他们获得了媒体关注。

They get media attention.

这些故事被大量放大。

There's a lot of amplification of those stories.

那么，这难道不是根本真相吗？因为资金被重新分配给了其他科学家和其他研究机构？

So is that not the fundamental truth because the money is being reallocated to other scientists and other research institutions?

没错。

Correct.

因此，有14%的NIH资金用于DEI研究。

So 14% of NIH funding went to DEI research.

14%。

14%.

NIH的14%拨款用于DEI研究。

14% of NIH grants went to DEI research.

NIH的拨款每年约为400亿美元。

And NIH grants are about 40,000,000,000 a year.

这听起来

Does that sound

实际拨出的拨款略高于200亿美元，但NIH的总预算约为470亿美元。

It's a little over 20,000,000,000 in terms of grants that go out the door, but about $47,000,000,000 for the entire NIH.

对于整个NIH而言。

For the entire NIH.

因为他们还运营自己的医院和临床中心等。

Because they run their own hospital and clinical center and others.

顺便说一句，我支持任何减少健康差异、提高可及性的举措，但这些拨款并没有实现这一目标。

So if you think of, and by the way, I'm all for anything that reduces health disparities and increases access, but these grants were not doing it.

它只是在描述健康差异。

It was just describing health disparities.

我们已经知道存在健康差异。

Well, we already know there are health disparities.

仅仅通过《美国医学会杂志》再发表50项研究来描述这些差异，并不能帮助那些深受健康差异之苦的人们。

Simply describing them with another 50 studies in JAMA does not help people who are suffering from these health disparities.

因此，我们看到资金已转向那些我们尚未研究、但亟需探索的健康问题的根本原因。

So we've seen money shifted to root causes in areas of research that we need to study that we've not studied.

在FDA，我们大力强调激素替代疗法对绝经后女性的价值，而NIH在过去二十二年里却一直贬低这种疗法，声称女性不应使用，因为它会导致癌症。

At the FDA, we have put a big emphasis on the value of hormone replacement therapy for post menopausal women, something the NIH demonized for the last twenty two years, saying that women shouldn't take it because it causes cancer.

我们上任时，NIH一片混乱。

When we came in, the NIH was a mess.

几乎所有的资金都流向了遗传学研究，这使得遗传学成为每个学术机构的优先事项。

Almost all the money was going to genetic research, which then becomes the priority of every academic institution.

他们没有研究病因、饮食、微生物组以及前沿科学领域。

They're not studying causes and food and the microbiome and cutting edge areas of science.

他们只是对一个领域有着狭隘的专注。

And they just had this myopic focus on one area.

这是一个重要的领域，但只是一个领域。

It's an important area, but it's one area.

他们资助了武汉实验室，以获取蝙蝠冠状病毒，并插入一个弗林切割位点，使其能够感染人类。

They were funding the Wuhan lab to, you know, get bat coronaviruses and insert a furan cleavage site so it could infect humans.

你们在做什么？

What are you doing?

这是一群疯狂的科学家。

It's a bunch of mad scientists.

有百分之十四的资助资金流向了多元化、公平与包容（DEI）项目。

And fourteen percent of grants were going to DEI.

所以，当我们接手时，NIH 一团糟。

So the NIH, when we came in, was a mess.

在特朗普总统领导下，它正在被大力改革，杰·巴塔查里亚做得非常好。

And under president Trump, it is massively being reformed, and Jay Bhattacharya is doing a great job.

好的。

Okay.

我们来谈谈疫苗吧。

Let's shift over to vaccines.

我们的妻子差不多同时生了孩子。

Our wives had kids around the same time.

嗯。

Yeah.

希望你的孩子很好。

Hope yours is doing well.

很好。

Great.

他很棒。

He's great.

谢谢你的关心。

Thanks for asking.

嗯。

Yeah.

我们还谈到了乙肝疫苗，孩子出生那天我们拒绝接种了。

And we talked about the hep b vaccine which we declined on the day he was born.

因为那天我开始深入研究新生儿接种乙肝疫苗的起源是什么？

Because I started going very deep on what's the origin of the hep b vaccine the day that the child is born?

为什么他们要打这个疫苗？

Why why is this being given to them?

我们家里没有人有乙肝暴露风险。

We have no hep b exposure in our household.

我们不需要这个疫苗。

We don't need it.

它也无法保护其他人。

It doesn't protect anyone else.

我们这么做是为了什么？

What are we doing this for?

你最终会陷入这些兔子洞，就像你之前提到的，你原本以为某些东西是理所当然的，但突然意识到不对劲。

You end up going down these rabbit holes and a lot of, again, what you mentioned earlier, you take for dogma and you recognize, wait a second.

这里可能存在一些缺乏依据的原则。

There may be some unfounded principles at play here.

我不应该这么做。

I should not be doing this.

我们违背了主流趋势和建议，做出了一个艰难的决定，结果突然间就与周围的人产生了社会冲突。

And we make a a difficult decision against the tide and the recommendations and suddenly you're in the social conflict with people around you.

对。

Right.

这非常艰难。

And it was very hard.

你们最近对疫苗接种时间表做了一些重大调整。

You guys recently made some big changes to the vaccine schedule.

我很想听听这些调整是如何做出的。

I'd love to hear a little bit about how those changes were made.

重大变化是什么？

What were the big changes?

然后，你知道，是什么让我们走到这一步，当你看数据时，会想：等等，有点不对劲。

And then, you know, kinda what got us to this point where when you look at the data, you're like, wait a second.

对。

Right.

这可能没那么有道理。

That may not make as much sense.

是的。

Yeah.

戴夫，听你说话我忍不住笑，因为你总是问一些很好的问题，比如：当妈妈乙肝表面抗原阴性时，我的新生儿在出生后第一小时真的需要注射乙肝疫苗吗？

I'm I'm just laughing as you talk, Dave, because you you do you know, you just ask some good questions like, does does my newborn in the first hour of life need to be injected with a hepatitis B vaccine when the mom is hep B negative?

在进行了更广泛的讨论后几周内，你就会感觉自己像个逃犯，好像因为你选择不接种疫苗而犯了什么大错。

And within a matter of weeks of having broader conversations, feel like you're a fugitive of the law, Like you've done something terribly wrong for choosing not to vaccinate.

我们也经历过同样的事情。

We went through the same thing.

成为父母的过程真是太特别了。

And being a part of having a kid is so special.

我们刚才就在聊这个。

We were talking about that.

所以，是的，我们刚刚经历了这些。

So yeah, we just went through this.

我们的儿子大约六个月前出生。

Our son was born about six months ago.

他们给我们提供了乙肝疫苗。

And we were offered the hepatitis B shot.

也许他们认出了我是谁，就没有像我一些朋友那样强烈地催促我们打针。

And maybe they figured out who I was and didn't push it as hard as some of my friends have had it pushed on them.

我们拒绝了。

And we declined.

乙肝是一种性传播感染，或者可以通过血液传播途径感染，接种疫苗可以预防这种感染。

You're preventing with hepatitis B an infection that is a sexually transmitted infection or can be, get it from a blood borne pathogen exposure.

所以这件事至少要等到他们十几岁，或者更久以后才会发生。

So that's not going to happen until they're a teenager at least or further down the road.

但当你提出这个问题时，立刻就会被贴上反疫苗的标签。

But when you ask the question, immediately you get this sort of anti vaxx label.

或者你必须加以说明。

Or you have to qualify.

那是

That's

对的。

right.

我不是反疫苗者，但我只是想问，这到底是怎么回事？这种围绕接种时间表的麦卡锡主义，顺便说一句，美国的疫苗接种计划在0到18岁之间推荐了72剂，是国际上的异类。

I'm not an anti vaxxer, but I'm asking this, right, what's going on here, this sort of McCarthyism around this schedule, which, by the way, The United States vaccine schedule was an international outlier with 72 doses recommended between the ages of zero and 18.

因此，特朗普总统让我们审查国际上的疫苗推荐情况。

So president Trump asked us to review the international landscape of vaccine recommendations.

我们研究了其他20个发达国家，发现不仅我们在推荐接种剂次数量上是国际异类，而且各国在核心必需疫苗方面存在共识。

And we looked at 20 other developed countries and found that not only are we the international outlier in in how high the number of doses we recommend is, but that there's a consensus of a group of core essential vaccines.

我们希望将这一点呈现给美国民众，告诉他们：所有疫苗仍然受到CDC的推荐，但这里列出了核心必需疫苗的清单。

And we wanted to put that in front of the American people to say, look, all vaccines are still recommended by the CDC, but here are a list of core essential vaccines.

因此，我们向他们提供了一份清单，涵盖从零岁到18岁期间约38剂疫苗。

So we gave them a list that constitutes about 38 from age zero to 18.

我们的目标是通过明确我们所认为的核心必需疫苗清单，来提升儿童疫苗接种率，因为近年来由于公众信任度下降，接种率一直在下滑。

And the idea is to increase vaccination rates among children that have been dropping because of a loss in public trust by saying, here's a hierarchy of what we believe to be a list of core essential vaccines.

我不希望看到有人因为医生建议一位健康、年仅12岁的女孩接种第六剂新冠加强针，就产生疑虑。

I don't wanna see someone because, you know, a doctor's pushing the sixth COVID booster in a young healthy 12 year old girl.

我不希望看到母亲说：‘我下一个孩子不打麻疹疫苗了，因为这件事有点不对劲。’

I don't wanna see the mom say, well, I'm not gonna get the measles shot for my next child because something's not right about this.

38剂总比零剂强。

38 is better than zero.

你仍然可以接种全部疫苗。

You can still get them all.

所有疫苗都是免费的。

They're all paid for.

但在医疗文化中，我们很难做到这一点，这属于医学社会学的一部分——即从人们所处的位置出发去理解他们。

But we have a hard time in the medical culture, and this is part of the sort of the sociology of medicine, meeting people where they're at.

例如，作为一名癌症外科医生，我曾见过一些女性告诉我她们不想做乳腺X光检查。

For example, as a cancer surgeon, I would see women tell me they don't want to get a mammogram.

我不同意，我认为乳腺X光是安全的，但女性可能担心辐射、不适或不便。

I disagree, I think they're safe, but a woman may be concerned about the radiation, the discomfort, the inconvenience.

如今，在美国，有40%符合乳腺X光检查条件的女性并未接受检查，这充分显示了医疗界与公众真实想法之间的巨大脱节。

Forty percent of women who are candidates for a mammogram are not getting a mammogram in The United States today, showing you the massive disconnect between the medical field and where people are at.

那么，你知道我们该怎么做吗？

Now, you know what we should be doing?

我们应该告诉那40%的女性：为什么不考虑做超声波检查呢？

Is we should tell those forty percent of women, how about an ultrasound?

超声波能检测出乳腺X光能发现的90%到95%的病灶。

It picks up ninety to ninety five percent of the lesions that a mammogram would pick up.

但医生们不推荐超声波检查，因为这违背了金标准，存在法律风险，而且会被认为是低于标准的医疗行为。

But doctors don't recommend an ultrasound because you're violating the gold standard and there's liability and there's, you know, and you're practicing substandard care.

女性可能会告诉其他女性，她们也可以做超声波检查。

And women may tell other women that they can also get an ultrasound.

我们不希望女性因为这种父权式做法导致的脱节而改做超声波检查，这种做法正在伤害美国今天的人们。

We don't want women getting an ultrasound instead of the paternalism that results in this disconnect is hurting people in The United States today.

因此，在确定核心必需疫苗清单时，我们正努力贴近人们的实际需求，以提高疫苗接种率，因为过去四年新冠期间儿童疫苗接种率有所下降，人们失去了对诸如幼儿戴布口罩、无限期接种疫苗加强针等教条的信任，甚至还要解雇教师。

And so with identifying the list of core essential vaccines, we are trying to meet people where they are at, to see more vaccinations because childhood vaccines have declined over the last four years of COVID because people have lost trust in the dogma of the, you know, cloth masks for toddlers and vaccine boosters in perpetuity, and you have to fire a teacher.

如果她已经感染过新冠，就忽略自然免疫。

If if she already had COVID, ignore natural media.

他们必须被解雇。

They have to be fired from their job.

这种绝对主义造成了巨大损害，我们正努力重建公众信任。

That, absolutism has caused tremendous damage, and we're trying to rebuild public trust.

让我感到沮丧的是，现在像加利福尼亚州这样的州，以及加州公共卫生部，正在宣布：我们要制定自己的疫苗接种时间表。

What's frustrating to me to observe is there are now states like California and the California DPH that are saying, we're gonna set our own vaccine schedule.

我们不再听从FDA和HHS的建议，因为他们不懂自己在做什么，因为他们是特朗普政府的人。

We're not gonna listen to the FDA, to the HHS anymore because they don't know what they're doing because they're Trump admin.

他们不是医生。

They're not doctors.

他们不是科学家。

They're not scientists.

很明显，这一切都是政治性的。

Clearly, this is all political.

你们和你们的组织有没有一个参与过程，试图让这些其他人也加入你们？

And is there a process of engagement that you and your organization go through to try and bring some of these other folks along with you?

因为我觉得你刚才提到的这一点，他们根本不可能从根本上反对。

Because I think the point you just made can't be a point that they could fundamentally disagree with.

我们该如何打破围绕疫苗等议题的政治敌意，采取一种清晰明确的科学方法，让人们达成共识？

What is what is the process by which we can break the political rancor around things like vaccines and just take a very clear cut scientific approach and get people aligned around this?

你们会做这方面的沟通吗？

Do you do engagement on this stuff?

我不看。

I don't look.

我觉得这很令人难过。

I I think it's sad.

我们陷入了这种有毒的两极分化。

We have this toxic polarization that's crept in.

这种现象渗透到了社会中，现在还变成了大量的人身攻击。

It's in society, but it's now crept into And it's a lot of character attacks.

我的意思是，这份报告是由拥有无可挑剔资历的医生们共同完成的。

I mean, it was put together by doctors with impeccable credentials.

特蕾西·贝丝·霍格博士，医学博士、哲学博士，是一位杰出的流行病学家，对这方面的科学有深入研究。

Tracey Beth Hogue, MD, PhD, phenomenal epidemiologist who is deep on the science on this stuff.

比如我们所有人，杰·巴塔查里亚博士，医学博士、哲学博士；梅赫梅特·奥兹博士，哥伦比亚大学外科学副主委。

You know, all of us, Jay Bhattacharya, MD, PhD Mehmet Oz, Vice Chair of Surgery at Columbia University.

我的意思是，这些人都拥有无可挑剔的资历，合起来有400多篇科学出版物。

I mean, these impeccable credentials, 400 scientific publications.

在我的职业生涯中，我在哈佛公共卫生学院、乔治城大学和约翰霍普金斯大学担任教职，拥有终身教职，并入选国家医学科学院，已发表350多篇经过同行评审的科学论文。

I've published three fifty scientific peer reviewed publications in my career at the Harvard School of Public Health at Georgetown at Johns Hopkins, on the faculty, tenured National Academy of Medicine.

这无关紧要，无论你向人们展示多少无可挑剔的资历，人们都有一种感觉：必须反对他们所说的任何话，因为有一种信条认为所有疫苗都是好的。

Didn't matter, all the impeccable credentials you can put in front of people, there's this sense of we just have to say the contrarian thing to whatever they are saying because of this sort of mantra of all vaccines are good regardless.

你无法进行一场诚实的对话。

And you cannot have an honest conversation.

我跟医生们交谈，他们从未听说过他们不喜欢的疫苗。

I talk to doctors and they've never heard of a vaccine they didn't love.

炭疽疫苗是一场灾难。

Anthrax vaccine was a disaster.

H3N3导致了人员死亡。

H3N3 killed people.

它是一场灾难，已被撤出市场。

It was a disaster taken off the market.

1999年的一种轮状病毒疫苗因婴儿出现肠套叠死亡而被撤市。

A rotavirus vaccine in 1999, taken off the market because kids were dying from intussusception.

轮状病毒疫苗并不在美国的核心必需疫苗接种计划中。

Rotavirus is not in our core essential vaccine schedule in The United States.

在国外，情况略有不同，但在我们发布的内容中，并没有包含这一点。

Overseas, it's a little different, but in in what we put out, it's not in there.

在大规模接种轮状病毒疫苗后，每年的死亡人数从三例降至一点六例。

After mass vaccination with rotavirus, the number of deaths per year went from three to one point six.

或者四舍五入，可以说是两例。

Or rounded up, let's say two.

通过大规模接种，死亡人数从三例降至两例。

Went from three to two with mass vaccination.

而1999年之前使用的那种疫苗，因安全问题被撤出市场。

And the vaccine that was used up until 1999 was taken off the market for safety concerns.

因此，当家长询问疫苗的必要性时，我们不能以绝对化的态度回应，美国医学需要展现出一些谦逊。

So when you have a parent ask a question about the necessity or we cannot respond with absolutism, American medicine needs to show some humility.

当有患者问我一个我不了解的问题时，正确的回答是：我不知道。

When I had a patient ask me a question I didn't know, the right answer, I don't know.

也许我会去查一查。

Maybe I'll look into that.

也许我的一位同事知道。

Maybe one of my colleagues knows.

在新冠疫情期间，很多时候正确的回答是：我们不知道。

During COVID, the right answer many times was, We don't know.

你觉得有前进的道路吗？

Do you find that there's a path forward?

我希望如此。

I hope so.

我的意思是，我们希望恢复黄金标准的科学，客观地讨论它。

I mean, we're hoping to restore gold standard science and just talk objectively about it.

我们已经看到一些大学取消、压制、打压那些对某些问题提出不同观点的医生。

We've had universities cancel, crush sensor, railroad doctors that, you know, pose different ideas about things.

我说的不是那些政治上的敏感话题。

And I'm not talking about the political hot button issues.

我说的是，胃溃疡并不是由压力引起的，而是由一种叫做幽门螺杆菌的细菌引起的。

I'm talking about the fact that ulcers were not caused by stress, they were caused by a bacteria called H.

幽门螺杆菌。

Pylori.

嗯，那个人被打压了。

Well, that guy was, you know, railroaded.

他的研究被拒绝在国家会议上发表，但后来他获得了诺贝尔奖，因为他最终是正确的。

His research was rejected from the national meetings and then he gets the Nobel Prize because he ends up being correct.

没错。

Correct.

这对科学来说不好。

And so it's not good for science.

大多数伟大的科学家最初都是异端。

Most great scientists start out as heretics.

顺便说清楚一点。

Just to be clear, by the way.

没错。

That's right.

是的。

Yeah.

马蒂，我们在这个国家经常讨论的另一个重大挑战是药品的成本。

Marty, one of the other big challenges that we talk a lot about in this country is the cost of drugs.

如今，医疗保健费用约占我们GDP的15%。

Healthcare today costs roughly 15% of our GDP.

这是一个惊人的统计数据，在美国，这一数字年复一年地攀升，而且这是一个极其复杂的问题。

That's an insane statistic and it is rising year after year in The United States, and it's such a complex issue.

不过，根据某些衡量标准，美国的药品价格几乎是美国以外地区的三倍。

By some measurements though, the price of drugs in The United States is almost three times what it is outside The United States.

所以我很想听听你们在药品定价方面所扮演的具体角色。

So I'd love to hear a little bit about the specific role of pricing drugs.

你们采取了哪些具体措施，未来还能做些什么来帮助降低患者、医疗提供者、保险公司，乃至整个经济的药品价格？

What sort of actions have you guys taken and can you take to help bring down the price of drugs for patients, for for care providers, for insurance companies, and ultimately for the economy?

这简直是美国人的巨大骗局。

It's been the great American rip off.

你在美国花1300美元买一种GLP-1药物，然后去伦敦。

You could buy a GLP one drug for $1,300 in The United States and go to London.

它在伦敦只卖88美元。

It sells for $88.

或者你去德国或法国，购买那些在美国价格高昂的药物，它们的价格只有美国的三分之一或四分之一。

Or you go to Germany or France and buy any of the drugs that cost a lot of money in The United States, and they're half a third or a quarter of the price.

因此，特朗普总统给了我们明确的指示，他说：看。

And so president Trump has given us a clear charge, and he says, look.

我们是全球最大的药品采购国。

We're the largest purchasers of drugs.

我们希望获得发达国家中最优惠的价格。

We want the best price in the developed world.

这被称为最惠国定价，感谢奥兹医生。

It's called most favored nation status pricing, And thanks to Doctor.

以及CMS的克里斯·克洛姆等人，我们在FDA也为此做出了贡献。

Oz and Chris Klomp and others at CMS, we did our part at the FDA to be a part of this.

我们已经让制药公司坐到谈判桌前，并让他们同意采用最惠国定价机制。

We've gotten drug companies to the table, and we've got them to agree to most favored nation status pricing.

这将大幅降低药品价格。

That's gonna radically lower the price of drugs.

以GLP-1为例，前三个月的价格将降至149美元。

With the GLP one example, for example, it's gonna come down to a $149 for the first three months.

其他国家将支付更多费用。

Other countries are gonna pay more.

我们一直为制药公司的研发成本承担60%的费用。

We have been financing 60% of the r and d cost to pharma companies.

其他国家也需要支付它们应承担的份额。

Other countries need to pay their fair share.

对于这位总统而言，无论是北约会费还是其他费用，他都希望看到其他国家支付其应承担的份额，而我们现在正实现这一目标。

And when it comes to this president, whether be NATO membership fees or whatever, he wants to see other countries paying their fair share, and so we're getting that delivered.

我们降低药品价格的另一种重要方式是减少FDA对生物制剂的繁文缛节。

Another big way in which we are going to lower drug prices is by cutting the red tape at the FDA for biologic drugs.

所以大多数，51%，让我稍微回退一下。

So most, 51% of the, so let me back up for a second.

医疗支出增长最快的领域是药品价格增长。

The fastest area of healthcare spending growth is drug price spending growth.

而药品价格增长最快的是被称为生物药的一类药物，这意味着你需要细胞系来生产它们。

And the fastest area of drug price spending growth are a class of medications called biologics, which means you need a cell line to manufacture them.

因此，这些药物的价格通常是六万、十万、十五万美元。

And so these are typically that 60,000, a 100,000, a 150,000 medications.

它们有被称为生物类似药的仿制药版本，但FDA批准生物类似药所需的繁琐程序耗时太长，需要五到八年，花费约三亿美元。

They have generic versions called biosimilars, but the FDA red tape to get a biosimilar approved has been so long and arduous, it takes five to eight years and $300,000,000 or so.

我们已经修改了要求，采用与小分子药物相同的原理。

We have changed the requirements so that we use the same principles we use for small molecules.

如果你在结构上与小分子品牌药相同，我们会根据其他一些条件批准你。

If you are structurally the same as a small molecule branded drug, we're going to approve you with some other stipulations.

因此，我们降低了生物类似药的研发成本超过一亿美元，并将审批时间从五到八年缩短至两年半或更短。

And so we are reducing the cost of R and D of biosimilars by a 100,000,000 plus dollars, and we are shortening the time frame from five to eight years to two and a half years or more.

因此，在本届政府期间，我们将看到一大批新的生物类似药问世。

And so we're gonna see a whole new class of biosimilars come out in this administration.

它们终于能够与生物药展开竞争。

They're gonna finally compete with the biologics.

现在，阿达木单抗（Humira）是最著名的生物药之一。

Now Humira is one of the most famous biologics.

在专利和市场独占期结束后，过了多年才出现生物类似药。

It took years after that patent ex market exclusivity for a biosimilar to come out.

当一种生物类似药终于上市时，阿达木单抗的价格并没有大幅下降，几乎像是隐性的价格合谋。

And when one did come out, you didn't see the price of HUMIRA come down that much, almost sort of an an implied price collusion.

我们需要大量生物类似药上市，而我们将看到生物类似药的闸门彻底打开。

We need a lot of biosimilars to come out, and we're gonna see the floodgates open up on biosimilars.

最后一点，为什么美国的许多药物都需要处方？

And then final point, why are a lot of drugs requiring a prescription in The United States?

我们担心的是什么？

What are we worried about?

有人过量服用止吐药，或者有人在没有处方的情况下购买前列腺药物。

Somebody overdosing on anti nausea medication or somebody picking up a prostate medication without a prescription.

这再次体现了医学中的家长式作风。

We've got, this is the paternalism in medicine again coming out.

这种家长式作风曾阻止女性使用家用验孕试纸，因为人们认为女性无法应对这类信息。

The same paternalism that blocked women from having home pregnancy tests, because, you know, women can't handle that information.

她们必须来医院，由我们来告诉她们。

They have to come in and we have to share it with them.

你看到的就是这种家长式作风，顺便说一句，新冠检测时又重演了这一幕。

It's this paternalism you see, and by the way, it happened again with COVID testing.

我们看到了，也就是家用新冠检测。

We saw it, well, home COVID testing.

我们为此打过一场仗。

We fought this battle.

我们想要家用新冠检测，但主流机构却说不行。

We wanted home COVID testing and the establishment was like, no.

不。

No.

我们必须告诉他们。

We have to tell them.

他们不能拥有这些信息。

They can't have this information.

为什么药物不能是非处方药？

What are why are drugs not over the counter?

我们会让更多的药物成为非处方药，让我告诉你为什么这能降低药价。

And we're gonna so we're gonna get more drugs over the counter, and let me tell you why that lowers drug prices.

因为当一种药物摆在商店货架上时，下面会标有价格。

Because when a drug is on the shelf in a store, there's a price underneath of it.

竞争和消费者购物行为有一种神奇的力量，即使只有一小部分消费者关注价格，也能为所有人控制价格。

And there is something magical with competition and people who shop, even if a small segment of the consumer market is shopping on price, it keeps prices in check for everybody.

因此，你将实现价格透明，并绕过药房福利管理者（PBMs）那些疯狂的金钱游戏。

And so you will enable price transparency, and you will bypass the crazy money games of PBMs, pharmacy benefit managers.

当你从柜台后面拿东西时，他们会为你结账。

When you pick up something behind the counter, they ring you up.

你根本不知道幕后进行的那些花招。

You have no idea the shell game that's going on behind the scenes.

你和你的雇主正被剥削，而你的PBM（药品福利管理公司）从中获利，销售PBM给雇主团体的经纪人每张处方可能赚取6.50美元。

You're with your employers getting ripped off and your PBM is is making money on this and the broker who sold the PBM to the employer group could be making $6.50 on every prescription set.

为了什么？

For what?

就为了让PBM告诉你你的共付额是多少，并设定共付额？

For the for the PBM just to tell you what your co pay is gonna be and set the co pays?

所有这些金钱游戏都会在阳光的消毒下，以及货架上的明码标价中消失。

All of those money games disappear with disinfectant of sunlight and a price on the shelf.

我们希望看到更多非处方药的大规模转型。

We want to see a mass transition to more non prescription drugs.

我在FDA的非处方药办公室引进了新的领导团队。

We have new leadership that I brought in at the Office of Non Prescription Drugs at the FDA.

我们希望看到企业申请将药品转为非处方药。

We want to see companies request to be non prescription.

而且它将有非常简单的标准。

And it's going to have very simple criteria.

如果您的药物没有滥用潜力，如果您的药物是安全的，如果您的药物不需要实验室检测——比如医生通常需要检查您的肝功能，或者不需要密切追踪，它就应该可以作为非处方药销售。

If your drug does not have abuse potential, if your drug is safe, if your drug does not require laboratory testing, which doctors, you know, we often need to check your liver function tests, or does not need to be closely tracked, it should be able to be over the counter.

如果您不会把这种药用在某个甲基苯丙胺实验室里制造危险的街头毒品。

If you're not gonna use the drug in some meth lab to make some dangerous street drug.

如果您符合这些基本标准，这种药物就应该成为非处方药。

If you meet those basic criteria, the drug should be non prescription.

想想那些无谓的急诊室就诊次数。

Think about the number of useless ER visits out there.

整个医疗工业复合体，每次您需要续药时就赚一笔。

The whole medical industrial complex, cha ching every time you need a refill.

比如我孩子传染给我结膜炎，要买到眼药水治好它真是麻烦透顶。

Like I got pink eye from my kids and it was such a headache to get the drops to get my pink eye to go away.