Scott Alexander critiques the FDA's slow approval process for Paxlovid, a promising COVID-19 treatment, despite its proven effectiveness. Longer summary

Scott Alexander discusses the FDA's delay in approving Paxlovid, a highly effective COVID-19 treatment. He criticizes the FDA for taking an estimated six weeks to approve the drug despite stopping trials early due to its effectiveness. The post explores the inconsistency in the FDA's approach, questions potential reasons for the delay, and emphasizes the urgency of approval given the ongoing COVID-19 deaths. Scott also addresses potential criticisms by comparing the situation to ivermectin and acknowledging the risk of unforeseen issues with Paxlovid. Shorter summary

Scott summarizes and responds to comments on his previous article about FDA approval of Paxlovid, acknowledging some valid points while maintaining his criticism of the approval process. Longer summary

This post summarizes comments on Scott's previous article about FDA approval of Paxlovid. It covers manufacturing challenges, FDA approval processes, production capacity, ongoing studies, and ethical considerations. Scott acknowledges some valid points raised by commenters about reasons for FDA delays, but maintains his criticism of the approval process, suggesting a need for different levels of approval and questioning the current drug approval system. Shorter summary

Scott Alexander reviews comments on his posts about aducanumab and the FDA, acknowledging some mistakes while defending his overall critique of FDA conservatism. Longer summary

Scott Alexander reviews comments on his recent posts about aducanumab and the FDA. He acknowledges some mistakes in his original post, but defends his overall critique of the FDA as overly conservative. The comments cover various aspects of drug approval, including the aducanumab controversy, surrogate endpoints, the FDA's impact on small biotech companies, and comparisons to other regulatory systems. Scott reflects on how to improve his fact-checking process while still writing passionate pieces. Shorter summary

Scott Alexander defends his criticism of the FDA's approval process in the infant fish oil case, arguing that systemic issues cause harmful delays even when the FDA follows its mandate. Longer summary

Scott Alexander responds to Kevin Drum's criticism of his interpretation of the infant fish oil story. He maintains that his account was substantially correct, despite some minor errors. Scott argues that the FDA's approval process, while following its mandate, causes unnecessary delays in life-saving treatments. He uses analogies to illustrate how the FDA's structure can be problematic even when individual employees perform well. Scott emphasizes that his criticism is not about the FDA failing its mandate, but about the design of the system itself causing delays in implementing known beneficial treatments. He concludes by addressing Drum's skepticism of FDA critics, arguing that anger towards the FDA often comes from personal experiences with its shortcomings. Shorter summary

Scott Alexander corrects and expands on the story of Omegaven, a life-saving infant nutritional fluid, using it to illustrate systemic issues with medical regulation and drug approval. Longer summary

Scott Alexander revisits a story about Omegaven, a fish-oil-based nutritional fluid for infants, correcting some details from his previous post. He explains how the fluid was discovered to prevent liver disease in infants requiring IV nutrition, and the challenges faced in getting it approved by the FDA. While the FDA comes off relatively well in the story, Scott argues that the real problem is the systemic hurdle of drug approval that makes everything in medicine illegal by default. He discusses how this hurdle makes scientific discoveries harder and potentially costs lives, even when many individuals involved are trying their best. Shorter summary

Scott Alexander argues that the FDA is too strict, not too lax, and proposes unbundling FDA approval to allow for more nuanced drug regulation. Longer summary

Scott Alexander criticizes an Atlantic article that argues for stricter FDA standards following the approval of aducanumab, an Alzheimer's drug with questionable efficacy. He contends that the FDA is already too strict, citing examples like the delayed approval of COVID-19 tests and vaccines. Scott argues that the FDA's excessive caution has likely cost many lives. He proposes unbundling FDA approval into separate decisions about legality, insurance coverage, and the FDA's endorsement level. This would allow for more nuanced approvals and potentially reduce costly mistakes while still permitting access to promising treatments. Shorter summary

Scott Alexander argues that the 33% rate of post-marketing safety events for FDA-approved drugs is not necessarily concerning and explains why post-marketing surveillance is a normal part of drug safety monitoring. Longer summary

Scott Alexander discusses a study showing that 33% of FDA-approved drugs in the past decade have faced post-marketing safety events. He argues that this doesn't necessarily mean the FDA is too lax, explaining that post-marketing surveillance is a normal and necessary part of drug safety monitoring. He points out that only 1.3% of drugs were actually withdrawn from the market, which he considers a good success rate. Scott explains why it's impossible to catch all potential side effects in pre-approval studies and gives examples of safety communications that range from important to seemingly trivial. He concludes that the 33% figure alone is meaningless without a broader cost-benefit analysis of FDA approval standards. Shorter summary

Scott Alexander discusses potential Trump administration health-related appointments, focusing on FDA commissioner candidates Jim O'Neill and Balaji Srinivasan, and their potential to implement beneficial reforms. Longer summary

Scott Alexander discusses potential Trump administration picks for key health-related positions, particularly the FDA commissioner and NIH chief. He expresses excitement about the possibility of Jim O'Neill or Balaji Srinivasan being chosen for FDA commissioner, viewing them as principled libertarians who could implement beneficial reforms. Alexander outlines several policies these candidates might pursue, such as medical reciprocity with other countries and streamlining generic drug approvals. He also mentions John Ioannidis as a surprising potential pick for NIH chief, praising his work in improving medical research standards. The post concludes by noting that pharmaceutical industry stocks haven't moved much in response to these potential appointments. Shorter summary

Scott Alexander compares the disconnect between American and Russian psychopharmacology to having different chemical elements, exploring why effective Russian psychiatric drugs are unknown in America. Longer summary

Scott Alexander discusses the stark contrast between American and Russian psychopharmacology, using an analogy of different chemical elements to illustrate the disconnect. He points out that many effective Russian psychiatric drugs are virtually unknown in America, despite having good evidential support. The post explores reasons for this divide, including FDA approval processes and legal concerns, and highlights the resulting limitations in treatment options for conditions like anxiety. Scott suggests that while the system's incentives lead to this seemingly irrational situation, a gray market for these drugs has emerged online. Shorter summary