Opinion

Opinion

The Lethal Cost of Regulatory Perfection in Rare Disease

Congress has already granted the FDA flexibility in evaluating therapies for rare diseases, including the use of real-world evidence and natural history data when traditional large-scale trials are not feasible. The question before the FDA now is not if those tools can be applied – they can – but if the agency has the courage to use them before more patients lose their autonomy, and ultimately, their lives, to rare disease.

Opinion
Health, wellness, doctor, AI

Prompting is Not Clinical Practice: The Limits Of General LLMs in Healthcare

General-purpose LLMs have meaningful value in healthcare - they can support education, documentation and research - as well as lower barriers to knowledge and help improve communication. But acting as a clinical assistant embedded in care delivery requires more - it needs longitudinal EHR grounding, explicit encoding of clinical guidelines, transparent and traceable reasoning and the ability to operate securely at a population scale.

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Opinion

The Pill Patients Saved

It reduced cravings, dulled alcohol’s “buzz,” and carried no risk of addiction. By every measure, naltrexone should have immediately become a major triumph. Instead, it flopped because the institutions charged with treating addiction refused to use it. Now considered a gold standard, it survived because patients and communities kept it alive.