4 ms·
Is anyone even reading my comment or any of the comments above me? I'm not arguing against the FDA's safety requirements. The argument is for decoupling safety
by themacguffinman 5y ago
Is anyone even reading my comment or any of the comments above me? I'm not arguing against the FDA's safety requirements. The argument is for decoupling safety from efficacy requirements to make a treatment available to acquire. Right now availability is coupled with mandatory coverage by Medicare & insurance, which means treatments with borderline/controversial efficacy results like this Alzheimer one is either totally banned or mandatory for prescription & coverage. You wouldn't be able to sell heroin.
- HarryHirsch 5y agodecoupling safety from efficacy requirements to make a treatment available to acquire That'll only serve to increase distrust in the FDA. Yeah, it's safe, but also, it's no good for anything. You wonder if that's the purpose of such initiatives, destroying trust in the public authorities to better be able to sell snake oil.
- themacguffinman 5y agoI'm sure that people who can read an FDA safety-only mark clearly labelled as safety-only will be just fine. The benefits of separating them are relevant to this exact Alzheimer treatment; It has controversial efficacy, but now the FDA had to decide between "all doctors, insurance, and Medicare must cover/prescribe it" or "no one is allowed to do anything with it". It will also serve to speed up the notoriously slow and expensive process to make something available and make grey-area treatments available. This completely fucked the FDA's early response to the initial need for COVID-19 testing kits. The FDA made a mistake as all organizations do, but its approval system is so inflexible it prevented many safe and realistically effective testing kits from being made available.