3 ms·

> A drug should be approved once it is very likely causing more good than harm. Err, that sounds really scary and wrong to me. Seems to me that a drug should b

> A drug should be approved once it is very likely causing more good than harm. Err, that sounds really scary and wrong to me. Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. It may be the case that we are better off taking a vaccine in a pandemic _even though we are not 100% sure it is safe_ due to the opportunity cost, and that's what emergency authorizations are for. Even if the FDA really did their due diligence here, it will not convince anyone who was not already convinced; it is obvious that they were going to approve it no matter what, because the political fallout of not approving it after so many people have taken it would permanently destroy what trust remains in the US public health system.

sixstringtheory 5y ago
> Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. How long is sufficient? How large of a test group is sufficient? In the "absolute" sense, there is no known drug that is safe. That is extremist thinking that only serves to muddy the waters of the actual debate, which should be: "how safe is safe enough?" > we are not 100% sure it is safe Note that "100% sure" does not mean "100%" safe. So how much safety do you need a 100% assurance for? How do you quantify the safety? > that sounds really scary How does this not just describe life in general? And how does that help policymaking? I don't think our species would have made it to the agricultural revolution if that was the overriding force for anything. > it will not convince anyone who was not already convinced This also strikes me as a poor consideration for any policymaker, as they likely know that at the onset to any such policymaking. This adds nothing new or interesting to the debate.
- stathibus 5y ago
  Its not my job to figure out "how safe" or "how certain", but I can definitely say with confidence that "more safe than harmful" and "more likely than not" are both really bad answers.
  - sixstringtheory 5y ago
    Unfortunately that is how the world works. It is not all or nothing, it is sets of probabilities and tradeoffs. You will rarely be able to solve complicated problems if your criteria are all or nothing. Few medicines are 100% safe. Nobody can predict the future. I'm sorry you're scared, so are many people, but this is the best option we have right now. I struggle to think of a better choice.

sixstringtheory 5y ago

> Seems to me that a drug should be approved when all the side effects are known, results are well characterized among a large sample set over a sufficiently long time frame, and it is determined that the drug is "safe" in the absolute sense. How long is sufficient? How large of a test group is sufficient? In the "absolute" sense, there is no known drug that is safe. That is extremist thinking that only serves to muddy the waters of the actual debate, which should be: "how safe is safe enough?" > we are not 100% sure it is safe Note that "100% sure" does not mean "100%" safe. So how much safety do you need a 100% assurance for? How do you quantify the safety? > that sounds really scary How does this not just describe life in general? And how does that help policymaking? I don't think our species would have made it to the agricultural revolution if that was the overriding force for anything. > it will not convince anyone who was not already convinced This also strikes me as a poor consideration for any policymaker, as they likely know that at the onset to any such policymaking. This adds nothing new or interesting to the debate.

stathibus 5y ago
Its not my job to figure out "how safe" or "how certain", but I can definitely say with confidence that "more safe than harmful" and "more likely than not" are both really bad answers.
- sixstringtheory 5y ago
  Unfortunately that is how the world works. It is not all or nothing, it is sets of probabilities and tradeoffs. You will rarely be able to solve complicated problems if your criteria are all or nothing. Few medicines are 100% safe. Nobody can predict the future. I'm sorry you're scared, so are many people, but this is the best option we have right now. I struggle to think of a better choice.