FDA CBER · 主任 医药与生物
Substack 和 YouTube 高产，观点激进
最近 3,650 天
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.
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.
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.
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.
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.
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.
Prasad认为Aquila设计前后矛盾：要么用PFS并以来那度胺为对照，要么用OS并对照真正的美国标准治疗。
如果PFS是冒烟型骨髓瘤的合适终点，对照组应为来那度胺。如果来那度胺因从未在干净的试验中显示OS获益而不是标准治疗，那么Aquila的终点就应是OS，且应与真正的美国标准治疗而非劣质治疗对比。原文 (en)
If PFS is a suitable endpoint for smoldering, the control arm should be Len. If Len isn’t standard of care for smoldering because it never shown an OS benefit (in a clean trial), then OS should be the endpoint of Aquila. But OS should be measured against actual US standard of care, not substandard care.
Prasad认为AI将极大颠覆认知型工作，并提到自己用AI工具核实生存曲线。
AI将对认知型工作产生极大的颠覆。原文 (en)
AI is going to be so, so disruptive for cognitive work
Prasad认为，若存在可治愈的标准疗法，患者不应参加毒性更高的1期试验，劝阻这类入组是正当的second opinion。
如果你有治愈几率达65-85%的治愈性方案，却去参加毒性更强的基础方案并加入已知抑制骨髓的在研药物的1期试验，这是个糟糕的决定。这是一种诚实的second opinion，我敢打赌私下里很多肿瘤医生也有同感。原文 (en)
If you have a curative option with a 65-85% chance of cure— participating in a phase 1 trial with a more toxic backbone and an investigational agent known to suppress marrow is a bad decision. That's an honest second opinion, and I bet privately many oncologists felt the same.
Prasad称，认为经过企业、IRB和监管审查的试验必然合乎伦理是一种妄想，错误仍然经常发生。
All trials have been vetted by the company, IRB, investigators, regulators— ergo all are ethical and good, the argument goes. This sadly is a delusion. All those protections and the Swiss cheese model holds true. Errors still happen. In fact quite often.
Prasad解释，劣质试验之所以存在，是因为企业、研究者和大学都有利益冲突，倾向于推动试验。
Companies are conflicted. They want their products to have more market share. Like parents they think all their kids are brilliant, even when they are dunces. Investigators have strong professional interests to run trials— even dubious ones. No one gets promoted by opposing bad trials. Universities make money from these trials.
Prasad指出，随机试验中成功概率极度偏斜（5%或95%）是劣质试验的标志，如设置稻草人对照或使用剧毒药物。
Lopsided probabilities in a randomized study 5% or 95% are a tell tale sign of a bad trial… like a straw man control arm or a super toxic drug.
Prasad 认为因聊天机器人提供减药方案而起诉 OpenAI 是美国特有现象，并强调这是当事人自己的选择。
只有在美国，你才能因为使用了一个恰好给了你所要求内容的工具而起诉。我没能读完完整的对话记录（可能有几千页），无法判断聊天机器人多频繁、多有效地劝阻过她的选择，但必须记住，那是她自己的选择。原文 (en)
Only on America can you sue for using a tool that gives you exactly what you ask for. I have not been able to read the full transcript, which is likely several thousand pages to see how often or how well the chat bot cautioned her against her choices, but it's important to remember they were her choices.
Prasad 认为针对特定药物的安全护栏很容易被绕过，既无法避免伤害也无法杜绝未来诉讼。
围绕抗癫痫药设置防护并不能解决问题。如果 AI 没有意识到咖啡因的提问是减少抗癫痫药的后门，家属或许还能起诉。毕竟 AI 不是应该很聪明吗。我怀疑如果 OpenAI 增加大量警告，用户会像我设想的那样绕过，之后仍可能有诉讼。原文 (en)
Building security around anti-epileptic medicine won't solve the problem. Maybe the family could then sue if AI did not realize the caffeine prompt was a backdoor way to reduce epilepsy medication. After all, isn't AI supposed to be smart. I suspect that if open AI adds lots of warnings then users will do as I imagine, and future lawsuits may follow.
Prasad 警告不要把新技术当作替罪羊，并呼吁厘清企业责任与个人决策的边界。
企业责任在哪里结束、个人决策从哪里开始？我们应当谨慎、准确地批评新技术，而不是把它们变成替罪羊。原文 (en)
When does corporate responsibility end an individual decision making begin? We should be careful to accurately criticize new technologies and not make them a boogie man.
Prasad认为医院在出院前向住院患者推行流感和新冠疫苗的政策缺乏证据，在随机试验证明获益前应当放弃。
事实是，这一政策需要通过以临床结局为检验效能的随机试验来验证，在结果呈阳性之前，应当放弃。这显然违背常识。原文 (en)
The truth is the policy needs to be tested in a randomized trial powered for outcomes and until the moment that results as positive, it should be abandoned. Clearly in violation of common sense.
Prasad警告说，给仍在患病恢复期的人接种疫苗，可能降低疫苗效果甚至加重病情。
也存在潜在的弊端。最明显的是，在你仍然生病时，疫苗可能效果不佳，甚至让病情更糟。现在不是进一步挑战免疫系统的时候。原文 (en)
There are potential downsides as well. Most obviously that the vaccine might not work well when you are still ill or make you worse. Now is not the time to further challenge the immune system.
Prasad 认为 Oncoalert 切断与俄罗斯肿瘤学家合作的做法毫无实际价值，当年叫好的医生们早已转移关注，属于姿态性表态。
Years later, it might be worth pointing out that not only did this accomplish nothing of value, but the folks who cheered such acts of virtue signalling have all moved on. For a while after the invasion, dozens of physician accounts constantly drew attention to the war— urging support for Ukraine. Now it is crickets.
Prasad 怀疑AI能否及时治愈肺癌，并警告国会不当监管可能催生联邦AI机构，扼杀创新。
接下来，我不确定AI能否及时治愈肺癌。国会可能很快会出台考虑不周的监管。届时会出现一个联邦AI机构，扼杀真正的创新，大量官僚主义拖慢进展。原文 (en)
Next, I'm not sure AI is going to cure lung cancer in time. It's possible that ill-advised Congressional action will soon regulate the space. There'll be a federal agency of AI that ensures real innovation is stifled and a massive amount of bureaucracy slows progress.
Prasad 认为AI在生物和化学领域受限于尚不存在的实验数据，不同于编程和数学。
在编程、下棋、数学方面，AI已有的条件就足够了。但在物理、生物和化学领域，AI可能需要尚不存在的实验结果才能充分形成假设。Anthropic正在建造一个以AI为首席研究员的实验室。原文 (en)
When it comes to coding, playing chess, doing mathematics, AI doesn't need anything more than it already has. But when it comes to physics, biology, and chemistry, AI may need the results of experiments that do not yet exist to fully develop its hypotheses in thinking. Anthropic is building a laboratory whose pi is AI.
Prasad 表示看好AI颠覆医学，但不会拿健康赌AI治愈癌症。
尽管我看好AI颠覆医学，但我还是不会去吸烟。原文 (en)
As much as I'm bullish about AI disrupting medicine, I'll stick to not smoking.
Prasad 认为 Moderna 疫苗的风险比与新辅助帕博利珠单抗的预期结果相当，疫苗在新辅助情境下是否仍有增益尚无答案。
风险比恰好就是在手术前而非手术后使用帕博利珠单抗（如 Moderna 与默沙东试验的做法）所能得到的结果。显而易见的推测是，这种极其昂贵、量身定制的疫苗与仍留在体内的肿瘤在免疫学上起到了同样的作用。如果在新辅助试验中使用，疫苗还会有效吗？只有另一项试验才能回答。原文 (en)
The hazard ratio was exactly what you would get if you give pembro before surgery instead of after (as the moderna merck trial does). The obvious speculation is the vaccine— incredibly costly and bespoke— and the tumor still in the body—do the same thing immunologically. Will the vaccine still work if you give it in a neo adjuvant trial? Only another trial will answer that.
Prasad 批评药企零碎释放试验数据的做法，指出安全性和删失等关键细节仍然缺失。
批评者天生处于劣势，因为新闻稿和摘要只展示产品积极的一面，而不展示负面。我仍然不知道副作用是什么，也不知道有多少患者被删失、失访或未完成治疗等。原文 (en)
Critics are inherently at a disadvantage as press releases and abstracts only showcase the positive side of the product and not the negatives. I still have no idea what the side effects were. I still have no idea how many patients were censored, lost to follow-up, did not complete therapy etc.
Prasad 提醒不要过度推广该结果，并称癌症治疗性 mRNA 疫苗商业前景良好，无需联邦进一步资助。
一种定制 mRNA 疫苗在一种免疫学上特殊的肿瘤术后有效，并不意味着：1 在新辅助使用帕博利珠单抗时有效；2 在其他肿瘤中有效；3 在转移性情境中有效；4 可以对用于传染病的 mRNA 疫苗得出任何笼统结论。具有讽刺意味的是，这意味着癌症治疗性 mRNA 疫苗利润丰厚、市场激励充足，不需要进一步的联邦支持。原文 (en)
Because one bespoke mRNA vaccine works in one immunologically interesting tumor after surgical removal does not mean 1 It will work if pembro is giving neo adjuvant 2 It will work in other tumors 3 It will work in the metastatic setting 4 Any sweeping lesson about mRNA shots used for infectious diseases It does mean ironically that Cancer therapeutic mRNA vaccines are financially lucrative, and have plenty of market incentives, and do not require further federal support.
Prasad提醒，通过非常规扫描偶然发现的癌症缺乏可参照的基线，创始人的良好预后不能简单归功于定制疗法（存在提前诊断与选择偏倚）。
我们知道，有些脑癌患者在出现剧烈头痛和癫痫发作后能存活约18个月，但对于通过他人没有做的MRI偶然发现的2级星形细胞瘤患者能活多久，我们并不清楚。是20年还是40年？当我听说某位创始人的2级星形细胞瘤3年后状况良好时，我不知道这是因为新疗法、早期诊断，还是给所有人做脑部MRI扫描本来就会出现的结果。原文 (en)
We know people with some brain cancers live 18 months from when they present with crushing headaches and seizures, but we have no idea how long people live whose grade 2 astrocytoma is incidentally found on an MRI others don't get. Is it 20 years or 40? When I hear about a founder with grade 2 astrocytoma who's doing well 3 years later I don't know if that's because of the novel treatment, the early diagnosis, or just what you'd expect if you scanned everyone's brain with MRIs.
Prasad认为，惰性肿瘤完整切除后未复发并不能证明定制疗法有效，而活跃生长的肿瘤在治疗后缩小才是可信的证据。
如果肿瘤被完整切除且惰性生长，那么无论你吃姜黄、希罗达还是接受新型定制基因疗法，它都要很久才会复发。相反，如果肿瘤在活跃生长、扫描可见，而你的疗法使其缩小，那就必须认真对待。原文 (en)
If you had a tumor fully resected, and it is indolent, it will take a long time to reappear no matter whether you eat turmeric, Xeloda, or take a novel bespoke gene therapy. If instead, your tumor was actively growing, visible on scans, and your cure made it shrink— that has to be taken seriously.
Prasad指出，新药与标准化疗联用时无法判断新药的贡献，医生凭个人印象下结论并不可靠。
如果你把新药与久经验证的基础方案（新药+化疗）联用，就不可能知道新药到底增加了什么。如果有医生说“我从没见过单用化疗有这么好的反应，所以新药一定有帮助”，那这位医生需要更多教育，或者根据你的目标把他招募为KOL。原文 (en)
If you use your novel drug with a tried and true backbone— new drug + chemo— it is impossible to know what <new drug> adds. If you have a doctor who says “I’ve never seen responses this good with chemo alone, ergo new drug must have helped” That doctor needs more education — or should be recruited as your kol depending on your goal.
Prasad认为针对稳定驱动融合蛋白的小分子抑制剂令人信服，而多肽疫苗则不那么可信，并强调平台与药物类别的既往成功率很重要。
如果你发现肿瘤带有一种在该癌症中稳定存在的罕见融合蛋白（例如DNAJB1-PRKACA），并据此做出靶向激酶活性的小分子抑制剂（或许借助RevMed的化学技术），那我是相信的。但如果用的是多肽疫苗，就没那么信了。平台和药物类别的历史与成功率很重要。原文 (en)
If you find your tumor has a rare fusion protein that is consistently found in the cancer— DNAJB1-PRKACA— for e.g. and you make a small molecule inhibitor targeting the kinase activity (perhaps leveraging RevMed chem), then yes, I am a believer. But if you use a peptide vaccine instead… not as much. The history of the platform and class and success rate of the platform and class matters.
Prasad提醒，带有MMAE等强效非特异性载荷的ADC可能仅靠载荷起效，需要额外证据才能证明新型靶向部分的作用。
如果你做了一个新药，但把它连接到MMAE或强效放射性同位素上，要注意载荷可能在杀死一个细胞之后或之前就被切断，载荷本身就能杀死癌细胞。足够高剂量的活性载荷ADC在靶点之外的地方也会起作用。微管抑制剂对很多癌症都有效。要让我相信新型ADC起了关键作用，需要额外的证据。原文 (en)
If you make a new drug but tether it to MMAE or a powerful radioisotope, note that the payload can be cleaved after killing one cell, or before, and the payload can do cancer killing all by itself. A high enough dose of an ADC with active payload will work in other places besides the target. Microtubule inhibitors work in a lot of cancer. It takes extra to persuade me that the novel ADC is critical to that.
Prasad 认为当前 AI 一味讨好用户，会随用户不满而改变答案，是终极谄媚者。
目前，AI 的目标是讨好用户。如果它给出的答案你不同意，你可以再次提示表达不满，它就会改变回答。它是终极的谄媚者。原文 (en)
Right now, AI aims to please. If it gives you an answer you disagree with, you can prompt it again with your displeasure and it will change it’s response. It is the ultimate sycophant.
Prasad 承认迄今 AI 存在自由派偏向，但认为这是因为模型只是模仿创造者而非真正思考。
AI 模型严重偏向开发它们的自由派中心，偏好自由派答案。我同意这一直是迄今为止 AI 的净偏向，但那些模型并不真正智能。AI 只是在模仿其创造者，而非思考。原文 (en)
AI models are heavily biased towards the liberal epicenters that have developed them, and favor liberal answers. I agree this has been the net bias of AI to date but those models were not truly intelligent. AI was pantomiming its creator and not thinking.
Prasad 认为药物风险获益评估存在客观正确答案，更强的 AI 可能突破人类认知局限找到它。
我的药物是否具有有利的风险获益比？我们把它当作主观问题，很大程度上确实如此，但部分原因是我们的头脑有限，对生物学的理解支离破碎、不完整。其实存在一个客观的正确答案。原文 (en)
Does my drug offer a favorable risk benefit profile? We treat that like a subjective question, and largely it is, but part of the reason is our minds are limited, and our understanding of biology is fragmented and incomplete. There is an objective right answer.
Prasad 警告，AI 通过解决实际问题积累可信度后，若对政治问题给出明确且无偏的答案，可能改变治理假设并动摇政治格局。
随着 AI 解决切实的现实问题，它将获得像 Jimmy 那样的可信度。如果它以非正统的方式明确回答政治问题，且在各问题上不偏向任何一方，它可能从根本上改变关于治理的核心假设。在一个日益部落化的世界里，它可能动摇我们的政治纲领。原文 (en)
As AI solves tangible real world problems it will gain the credibility of Jimmy. If it answers political questions definitively, and in a heterodox manner, betraying no bias to one side or the other across questions, It may fundamentally alter core assumptions about governance. In an increasingly tribal world, it may destabilize our political platforms.
Prasad 指出 AI 给出的部分数学证明已超越人类，且正确、富有创新。
AI 如今给出的至少一些数学解法超越了人类，而且巧妙、创新、富有灵气。至少其中一些证明是正确的。原文 (en)
At least some of the mathematical solutions AI has now offered surpass human beings and are also clever, innovative, and show flare. At least some of these proofs are correct.
Prasad 表示，一旦在晚期疾病中证明获益，FDA 对预防性疗法将持非常开放的态度。
一旦在晚期疾病中确立了获益，监管机构对预防性疗法将非常开放。原文 (en)
The agency will be extremely open-minded about preventives once the benefit has been established in later disease,
Prasad警告，基因疗法或神经药物领域的类Theranos欺诈可借助中途更换终点、无对照联合用药、历史对照等薄弱试验设计长期存活。
如果她做的是基因疗法或神经系统疾病药物，并做出同样虚假且有害的宣称，她可能至今仍拥有一家数十亿美元的公司。虚假承诺需要数年才会被发现——如果能被发现的话。她只需在试验中途更改终点，采用联合用药且不设对照组，或者声称根本无法随机化而使用历史对照。原文 (en)
If she made a gene therapy or drug for neurologic disorder, and made similarly false and harmful claims, she may yet still have a multi-billion dollar company. It takes years— if at all— for the false promise to be detected. She could just change her endpoints mid-trial, give her drug in combination and without a control arm, or claim that you can’t randomize at all and use historical controls.
Prasad认为，许多生物技术产品宣称的长期获益远比Theranos那种可即时验证的宣称更难核实。
伊丽莎白·霍姆斯做的是第一种盒子——她的宣称是近端的、即时的、易于测量的。生物技术领域的许多人做的是第二种盒子：承诺让人活得更长更好的药物、器械和生物制品。原文 (en)
Elizabeth Holmes made the first box— her claims were proximal and immediate and easy to measure. Many in biotech make the second box. Drugs and devices and biologics that promise a longer and better life.
Prasad批评医学界无意区分真创新与伪创新，只针对Theranos而忽视大量类似案例。
医学界没有兴趣区分真正的创新与伪创新。只把Theranos归入后者，却看不到无数类似的情形，正反映了这一点。原文 (en)
There is no interest in medicine in separating real innovation from pseudoinnovation. Singling out Theranos in the latter category, but not seeing it in countless analogous situations reflects that.
Prasad称生物技术记者缺乏医学专业知识，吹捧的承诺突破的公司与Theranos并无二致。
报道生物技术的记者缺乏医学专业知识，看不出Theranos和……他们在下一篇文章中吹捧的、承诺未来突破的公司完全一样。原文 (en)
The journalists who cover biotech lack medical expertise and can’t see that Theranos is exactly the same as…. the company they are plugging in the next article promising future breakthroughs.
Prasad认为夸大宣称在创业者中普遍存在，霍姆斯并非极端个例。
伊丽莎白·霍姆斯处在创业者撒谎光谱中的某个位置。她夸大了宣称，许多其他人也是如此。老实说，在那些声称提供革命性服务的人当中，她的撒谎程度可能只在第80百分位。原文 (en)
Elizabeth Holmes is somewhere on a spectrum of startup founders lying. She overstated claims. So do many others. She is probably only in the 80th percentile of lying to be honest among those who claim to offer revolutionary services.
Prasad认为从不吸烟的70岁老人不应做肺部CT或全身核磁共振筛查，因为这些干预未被证明有益。
从不吸烟的70岁老人应该排队去做肺部CT扫描吗？全身核磁共振？我的回答是否定的。他们不应该，原因很简单：这些干预措施尚未证明有益。原文 (en)
Should help a 70-year-olds who have never smoked line up to get CT scans of the lung? Whole body. MRIs? My answer is no. They should not for the simple reason that these interventions have not demonstrated benefit.
Prasad指出即便对长期吸烟者，肺癌CT筛查证据也薄弱，NLST后续数据和NELSON试验均未显示全癌死亡率下降。
即使在最可能获益的人群——长期吸烟者中，肺癌CT筛查也存在争议。Pinsky关于NLST的后续发表中，它未能维持死亡率获益。NELSON试验是一场灾难，方案一改再改，却没有降低全癌死亡率。原文 (en)
Even in a population most likely to derive benefit- long time smokers-- ct screening for lung cancer is disputed. It has failed in a follow-up publication by Pinsky regarding the nlst to sustain a mortality benefit. The Nelson trial is a disaster. It's protocol amendment after protocol amendment with no all cancer mortality reduction.
Prasad提出教皇利奥的肺癌可能是VIP医疗导致的过度诊断，进而带来不必要的手术。
第三种可能是，由于教皇不吸烟，也由于VIP医疗的偏差，他被诊断出一个在其余生中都不会进展或造成伤害的结节。原文 (en)
The third possibility is that, by virtue of the Pope being a non smoker, by virtue of the biases of VIP medicine, he has been diagnosed with a nodule that would not have progressed or caused harm in the rest of his natural life.
Prasad批评《纽约时报》对教皇癌症的报道忽视过度诊断可能、专家观点片面。
我对《纽约时报》这一报道的异议在于，他们完全无法考虑第三种可能性。没有一位专家提到它。原文 (en)
My objection to the New York Times coverage of this topic is that they are utterly unable to consider the third possibility. None of the experts raise it.
Prasad 认为基因组测序对健康人或常见病患者几乎没有实际价值，因为生活方式和治疗建议对所有人都一样。
然而，Brian 说得对：对于健康人（或患有常见疾病如高血压的人）来说，答案是：基因组知识几乎没有实际价值。不是说你完美无缺、无法改进，而是我们所有人需要做的事情都一样。原文 (en)
Yet, Brian is correct that for healthy people (or those with common conditions, e.g. HTN) the answer is: genomic knowledge has little to no practical value. It isn't that you are perfect and can’t improve. It's that we all need to do the same things.
Prasad 指出肿瘤医学中的基因组应用主要依赖肿瘤基因组，而非患者自身的胚系基因组。
在肿瘤医学中，基因组被广泛使用。我们主要使用的是癌症的基因组，而不是你的。只有极少数 HLA 特异性疗法和移植会用到你的部分基因组。原文 (en)
In cancer medicine, the genome is use commonly. Mostly we use the Cancer's genome. Not yours. Only a tiny handful of HLA specific therapies, transplant, use a portion of your genome.
Prasad 表示帕博利珠单抗等重磅药物的巨额销售源于宽泛的适应症标签，而非基因组靶向。
过去二十年最大的药物与基因组毫无关系。它们巨大的市场份额得益于宽松的适应症标签。帕博利珠单抗之所以能赚数千亿，正是因为它的作用如此不加区分。原文 (en)
The biggest drugs of the last two decades have nothing to do with the genome at all. Their large market share is buoyed by the permissiveness of the label. Pembro makes hundreds of billions precisely because it works so indiscriminately.
Prasad 承认基因组学帮助了罕见病和儿童疾病的诊断，并催生了定制化基因编辑疗法，但治疗常常滞后。
罕见病和儿童疾病也在诊断上受益于基因组学——尽管治疗往往滞后。对于某些疾病，我们现在已有定制化的基因编辑疗法。原文 (en)
Rare and childhood diseases have also benefitted from genomics in diagnosis— though treatments often lag. For some diseases, we now have bespoke gene editors.
Prasad 警告称，与简单的酶缺陷修复不同，基因疗法可能难以逆转缺陷蛋白多年累积造成的结构性损伤。
修复酶促过程中的小缺陷是一回事，修复大的结构性缺陷——缺陷蛋白在细胞中堆积多年——然后指望逆转损伤，则完全是另一回事。原文 (en)
Fixing small defects in enzymatic processes is one thing, fixing large structural defects, where the defect proteins pile up in cells over years, and then hoping to undo the damage is quite another.
Prasad 认为“基因组是一本书”的比喻危害很大，因为 DNA 是远比文字复杂的动态三维分子。
归根结底，把人类基因组比作一本告诉你如何构建和运行一个人的书中字母的想法——这个比喻造成了很大的危害。原文 (en)
Ultimately, the idea that the human genome is like the letters in a book that tells you how to build and run a person— that analogy has done a lot of damage.