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This thread is about decoupling efficacy from safety, not releasing potentially fatal treatments. The whole point of Scott's article is that we can keep basic s

This thread is about decoupling efficacy from safety, not releasing potentially fatal treatments. The whole point of Scott's article is that we can keep basic safety requirements but the efficacy requirements for FDA approval are much stricter and should be decoupled. The FDA can give a lower level of approval to treatments like this Alzheimer one that has controversial/borderline efficacy evidence instead of making a black & white choice between "not allowed at all" and "fully endorsed and must be covered by Medicare & insurance". No one is arguing to get rid of safety requirements or the FDA. The FDA will still be empowered to give a recommendation based on efficacy, but the lack of an efficacy recommendation should not prevent people from getting a treatment. The FDA is necessarily conservative, slow, and sometimes makes mistakes. That has a real cost if it acts as the sole gatekeeper for efficacy, a prime example being early COVID-19 test kits.

andrekandre 5y ago
why would we want to sell drugs that are "safe" but ineffective? imagine someone is in need of an effective treatment, but they don't like it or heard some rumors on tv or youtube, then instead they take an ineffective drug and think they aren't contagious, yet now they are potential spreaders of a disease... that doesn't sound safe at all to me.
- themacguffinman 5y ago
  > why would we want to sell drugs that are "safe" but ineffective? Because "ineffective" in your question actually means "not proven by the FDA to be effective" and the FDA, like all organizations, isn't perfect or perfectly responsive. For example, early COVID testing kits by third party labs that were safe and realistically effective but not yet approved. For example, this Alzheimer treatment that has controversial efficacy but the FDA could only choose between banning it completely or forcing insurance & Medicare to cover it. We can make exceptions in scenarios where ineffective treatments have unusually high external risks such as the COVID-19 pandemic before effective vaccines were available. Now, someone who pays attention to the FDA can use an FDA approved vaccine to immunize themselves to the disease spread by people who make decisions based on YouTube rumors. Sounds safe enough to me. We each make our own choices.
  - andrekandre 5y ago
    > We each make our own choices. yes we do, but the caveat is, we dont live in isolation from one another, so in cases such as covid, people being able to take "proven safe but unknown effectiveness" medications is a recipe for unintentional spread to others... this is the opposite of safe imo

andrekandre 5y ago

why would we want to sell drugs that are "safe" but ineffective? imagine someone is in need of an effective treatment, but they don't like it or heard some rumors on tv or youtube, then instead they take an ineffective drug and think they aren't contagious, yet now they are potential spreaders of a disease... that doesn't sound safe at all to me.

themacguffinman 5y ago
> why would we want to sell drugs that are "safe" but ineffective? Because "ineffective" in your question actually means "not proven by the FDA to be effective" and the FDA, like all organizations, isn't perfect or perfectly responsive. For example, early COVID testing kits by third party labs that were safe and realistically effective but not yet approved. For example, this Alzheimer treatment that has controversial efficacy but the FDA could only choose between banning it completely or forcing insurance & Medicare to cover it. We can make exceptions in scenarios where ineffective treatments have unusually high external risks such as the COVID-19 pandemic before effective vaccines were available. Now, someone who pays attention to the FDA can use an FDA approved vaccine to immunize themselves to the disease spread by people who make decisions based on YouTube rumors. Sounds safe enough to me. We each make our own choices.
- andrekandre 5y ago
  > We each make our own choices. yes we do, but the caveat is, we dont live in isolation from one another, so in cases such as covid, people being able to take "proven safe but unknown effectiveness" medications is a recipe for unintentional spread to others... this is the opposite of safe imo