言论追踪
Vinay Prasad FDA CBER · 主任
出处 ↗

Prasad认为冒烟型骨髓瘤试验中唯一有意义的终点是总生存期,因为早期治疗在未证明获益时只会增加毒性和成本。

对于冒烟型骨髓瘤,唯一重要的终点是总生存期。毕竟,用权宜性方案治疗癌前状态,从定义上就增加了毒性和成本。肿瘤最终仍会生长,最终仍会致命。
原文 (en) With smoldering myeloma, the only endpoint that matters is overall survival. After all, if you treat a pre-cancer with a temporizing regimen, you add toxicity and cost, by definition. Your tumor will still eventually grow, and it will still eventually kill you.

查看 Vinay Prasad 的全部言论 ›

Vinay Prasad 近期的其他言论

出处 ↗

Prasad 认为 AI 工具和私营市场而非政府最能解决获得医疗咨询的难题,其信息质量超过大多数医生。

解决方案很可能来自私营市场和 AI 驱动。这些工具大幅降低了提出医疗问题的门槛,其信息质量超过大多数医生。技术而非政府最适合解决这一问题。
原文 (en) The solution here is likely to be private markets and AI driven. These tools dramatically lower the barrier to ask medical questions, and the quality of the information surpasses most doctors. Technology and not government is best poised to address this.
出处 ↗

Prasad 称许多新药和器械无效或弊大于利,ACA 让游说者把未经证实的产品纳入公共支出,使问题恶化。

许多新上市的药物、器械和疗法无效,或危害大于获益。ACA 允许游说者把越来越多未经证实的疗法、策略和产品加到公共账单上,只会加剧这一问题。
原文 (en) Many novel drugs, devices and procedures debuted don’t work/ have harms exceeding benefits. The ACA has only exacerbated this problem by allowing lobbyists to add more and more unproven remedies, tactics, strategies and products to the public tab.
出处 ↗

Prasad 怀疑政府控费会以价值为导向,预计会不加区分,打击变革性与边际产品的研发动力。

我对其以价值为导向几乎没有信心。也就是说,我怀疑政府会削减边际商品和服务的支出并激励创新和有价值的服务。更可能的是做法草率且不加区分,导致变革性产品和边际产品都缺乏研发动力。
原文 (en) I have little confidence it will be value driven. In other words, I doubt that government will reduce spending on marginal goods and service and incentivize innovation and valuable services. Instead, very likely it will be done haphazardly and indiscriminately resulting in disincentives to make transformative products and marginal products alike.
出处 ↗

Prasad 警告控费将依赖分层和任意延迟,使美国消费者获取新疗法时更加受挫。

同样,由于我们无法区分好产品和边际产品,成本控制将依赖分层结构、任意拖延等手段,这很可能进一步加剧美国消费者的不满。
原文 (en) Again, because we are unable to differentiate good vs marginal products, cost control will rely on tiered structures, arbitrary delays, etc. This will likely result in further frustration from the American consumer.
出处 ↗

Prasad指出像Aquila这样的试验可能通过全球开展并以劣质护理作对照,人为制造总生存获益,而非对照真正的美国标准治疗。

因此唯一合适的研究是将早期治疗与当前标准治疗随机对照并测量生存。但这很困难,也不利于提升产品使用率,所以取巧的办法是把早期治疗与劣质护理对比——如果在全球范围开展试验,对照组会表现很差——就能轻松显示总生存获益。
原文 (en) So the only appropriate study would be to randomize to early treatment vs current standard of care, and measure survival. But that would be difficult, and make it hard to increase uptake for your product, so the easy cheat code is to randomize to early treatment vs poor care— if you run your trial globally the control arm will tank— then you can easily show a OS benefit.