Recap of FDA Categories and Examples

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In this special episode of The Drive, Peter addresses the recent headlines linking acetaminophen (Tylenol) use during pregnancy to autism in exposed children. Recognizing the confusion these claims have sparked among patients, listeners, and the broader public, Peter uses this episode to provide a framework for thinking critically about complex conditions and the research related to them. He highlights the dramatic rise in autism diagnoses over recent decades, noting that multifactorial conditions rarely have a single cause, and emphasizes the importance of resisting oversimplified explanations. Peter also stresses that humans are not naturally wired for scientific thinking, making disciplined frameworks like the Bradford Hill criteria essential for evaluating causality in epidemiology. Ultimately, he uses this framework to explore the evidence surrounding acetaminophen use during pregnancy and its potential link to autism.

We discuss:

• Laying the groundwork for this discussion, the rise in autism rates, and the value in using frameworks [1:00];
• The FDA pregnancy drug categories, where Tylenol falls within that framework, and a structured method for evaluating scientific evidence and causality [6:00];
• What exactly are the claims being made about acetaminophen and autism? [13:45];
• The increase in autism rates and why so many things are being linked to autism: the multiple comparisons problem [15:00];
• Evaluating the review paper that triggered the recent concern over acetaminophen and autism [21:45];
• Breaking down the largest studies on prenatal Tylenol exposure and autism: is there a causal link? [35:00];
• Why observational studies can’t prove causality, the role of confounding variables, and the importance of frameworks like the Bradford Hill criteria [43:30];
• Applying the Bradford Hill criteria: testing the case for Tylenol and autism [45:45];
• Putting it all together to answer the question: Does acetaminophen use during pregnancy increase the risk of autism? [56:15];
• If autism risk is overwhelmingly genetic, what explains the dramatic rise in autism diagnoses? [59:15];
• Other risk factors for autism: parental age, maternal health, environment, and where Tylenol fits in [1:09:15];
• Medication use during pregnancy: balancing risks, benefits, and FDA categories [1:15:15];
• Considerations for taking Tylenol during pregnancy [1:19:30];
• Final thoughts: critical thinking, balanced risk assessment, and the importance of context when evaluating medications like Tylenol during pregnancy [1:22:30]; and
• More.

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