RFK Jr.’s hand-picked committee approves manufacture of peptides he uses

小罗伯特·肯尼迪亲手挑选的委员会批准了他所使用的肽类药物的生产

In a widely expected move, a committee organized by the Food and Drug Administration (FDA) has voted to endorse removing restrictions on the manufacture of peptides for human use. Thursday’s panel meeting saw a sharply divided group recommend lifting limits on four peptides; votes on three additional peptides are scheduled for today. The move comes despite a continuing lack of evidence regarding their safety and effectiveness.

在一项广受预料的举措中，由美国食品药品监督管理局（FDA）组织的一个委员会投票支持取消对人类使用肽类药物生产的限制。在周四的小组会议上，一个意见严重分歧的团体建议解除对四种肽类药物的限制；针对另外三种肽类药物的投票定于今天进行。尽管目前仍缺乏关于这些药物安全性和有效性的证据，但该举措依然得以推进。

The move had been telegraphed months earlier as peptide enthusiast and Health and Human Services Secretary Robert F. Kennedy Jr. took steps to ensure this outcome.

这一举措在几个月前就已露出端倪，当时作为肽类药物拥护者的卫生与公众服务部部长小罗伯特·肯尼迪（Robert F. Kennedy Jr.）采取了行动以确保这一结果。

Like proteins, peptides are composed of amino acids that are chemically linked into a chain. Peptides differ merely by length; they’re often 10–20 amino acids long, in contrast to proteins, which can be hundreds or thousands. Some of them, such as insulin, are specifically made by targeted processing of a protein into shorter fragments, and the resulting peptide interacts with receptors that have evolved to send signals to cells based on its levels.

与蛋白质一样，肽是由化学键连接成链的氨基酸组成的。肽的区别仅在于长度；它们通常由 10 到 20 个氨基酸组成，而蛋白质则可能包含数百或数千个氨基酸。其中一些，如胰岛素，是通过将蛋白质定向加工成较短片段而专门制造的，由此产生的肽会与受体相互作用，这些受体已经进化到可以根据其水平向细胞发送信号。

But a lot of peptides are just the result of the messy complexity of biology, where larger proteins may break down in a way that consistently produces a stereotypical pattern of fragments. Some of those fragments, being relatively short and flexible, may stick to other proteins in ways that trigger some sort of physiological response. Others may simply be digested and recycled without doing anything of note.

但许多肽只是生物学复杂混乱的结果，较大的蛋白质可能会以某种方式分解，从而持续产生典型的片段模式。其中一些片段由于相对短小且灵活，可能会以某种方式附着在其他蛋白质上，从而引发某种生理反应。而其他的则可能仅仅被消化和回收，而不产生任何显著作用。

Understanding how a peptide is made and what downstream effects it triggers can take decades of research. In many cases, we have some evidence of what happens when we expose cultured cells to a peptide, but lack any indication of what might happen if an intact animal is. (Notably, transiting this same evidentiary gap is often where promising-looking drug candidates turn into failed ones.)

了解一种肽是如何制造的以及它会引发什么下游效应，可能需要数十年的研究。在许多情况下，我们有一些关于将培养细胞暴露于肽类物质后会发生什么的证据，但缺乏任何关于完整动物在接触后会发生什么的迹象。（值得注意的是，跨越这一同样的证据鸿沟，往往是那些看起来很有前景的候选药物最终失败的地方。）

RFK Jr. and many like him, who fear the clearly defined and well-understood proteins in vaccines, are perfectly willing to inject various peptides in the complete absence of any safety data. However, unlike most of the peptide fans who share anecdotes online, Kennedy is in a position to turn his hobby into policy.

小罗伯特·肯尼迪和许多像他一样的人，虽然对疫苗中定义明确且广为人知的蛋白质感到恐惧，却完全愿意在没有任何安全数据的情况下注射各种肽类物质。然而，与大多数在网上分享轶事的肽类爱好者不同，肯尼迪有能力将他的个人爱好转化为政策。

While the FDA has already used its standard processes to approve peptide drugs like insulin and some recently developed weight loss drugs, the lack of safety and efficacy data has kept most peptides off the market. The Biden administration also blocked their manufacture by compounding pharmacies, which make specialty drugs. But, earlier this year, Kennedy announced his interest in reversing that ban.

虽然 FDA 已经利用其标准流程批准了胰岛素和一些近期开发的减肥药等肽类药物，但由于缺乏安全性和有效性数据，大多数肽类药物仍未获准上市。拜登政府此前也曾阻止配制药房（生产特殊药物的药房）生产这些药物。但今年早些时候，肯尼迪宣布他有意推翻这一禁令。

At the time of his announcement, Ars’ Beth Mole wrote, “Outside experts and watchdogs suspect that before the first meeting in July, Kennedy will work to stack the advisory board with questionably qualified allies who will come with a predetermined decision to ease access to the drugs—no rigorous scientific evaluation needed.” That’s exactly what came to pass.

在他宣布这一消息时，Ars 的贝丝·莫尔（Beth Mole）写道：“外部专家和监督机构怀疑，在 7 月份的第一次会议之前，肯尼迪会设法在咨询委员会中安插资质存疑的盟友，他们会带着预先决定好的方案来放宽对这些药物的获取——无需任何严格的科学评估。”而这正是后来发生的事情。

In June, Kennedy added members to the advisory group who, with one exception, had obvious interests in the manufacture and sale of the unapproved peptides. Yesterday, those newly appointed members provided the decisive votes for overturning the ban, with all of the pre-Kennedy members voting against doing so.

今年 6 月，肯尼迪向该咨询小组增加了成员，除一人外，其余成员在未获批肽类药物的生产和销售方面都有明显的利益关联。昨天，这些新任命的成员为推翻禁令投下了决定性的一票，而所有在肯尼迪加入之前的成员都投了反对票。

Despite Kennedy’s earlier claim that “independent experts will rigorously evaluate each substance on its scientific merits using full clinical, pharmacological, and safety evidence,” no such evidence was presented at the meeting. According to The New York Times, when asked by a committee member whether the FDA had ever approved anything that had never been tested in humans before, an FDA official said it had not.

尽管肯尼迪此前声称“独立专家将利用完整的临床、药理学和安全证据，根据科学价值严格评估每种物质”，但会议上并未提供此类证据。据《纽约时报》报道，当被委员会成员问及 FDA 是否曾批准过任何从未在人体上进行过测试的药物时，一位 FDA 官员表示从未有过。

That may be a critical factor in what happens next. The committee’s role is advisory, and the FDA could reject its recommendations. Doing so, however, would place the FDA’s experts in direct conflict with the wishes of Kennedy, who can simply fire them.

这可能是接下来事态发展的关键因素。该委员会的角色是咨询性的，FDA 可以拒绝其建议。然而，这样做会使 FDA 的专家与肯尼迪的意愿发生直接冲突，而肯尼迪完全可以直接解雇他们。