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 He points out that only 1.3% of drugs were actually withdrawn from the market, which he considers a good success rate.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 drafts a letter to the FDA arguing against their decision to halt 23andMe's genetic testing services, highlighting the benefits and addressing the FDA's concerns. Longer summary

Scott Alexander writes a letter to the FDA expressing concern about their decision to halt 23andMe's genetic testing services. He argues that personal genomics services like 23andMe provide valuable and affordable genetic information to patients and doctors, raise awareness about genetics, and contribute to genetic research. Scott counters the FDA's concerns about false positives, test validation, and patient self-management, suggesting that these issues are either manageable or apply to many other medical tests and information sources. He urges the FDA to work with 23andMe to ensure their service returns to the market quickly. Shorter summary