> This drug was approved under an emergency order and this side effect was not listed.
Sadly, this is the case. The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. In the EU this regulatory pause of AZ has likely killed thousands of people.
> The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.
Or, more generally, in the emergency-order regime, all decisions that can demonstrate a clear 10:1 improvement in expected deaths should be taken, regardless of regulatory red tape.
The FDA and other regulators have over-fitted their process for "minimize likelihood of another Thalidomide, for drugs which have a small chance of saving a life, and a very small chance of causing harm". This is defensible for testing a new statin, where we have existing safe drugs to choose from, and we're looking for incremental improvements. But it's shockingly harmful in an emergency.
One thing that has become very clear is that the FDA and other regulators are structurally incapable of making even rudimentary risk-based tradeoffs in emergency situations, and we need to fix this.
> The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require.
A drug regulator should do its job, which is following established rules for approving and recommending new medicines. Not invent new rules, not push experimental drugs when new problems are being discovered on the go. Advocating for "greater-good" trade-offs and risks is a political effort, the regulator should be immune from political pressures.
I'm glad people there prefer to err on the side of going with established rules and caution.
If what you want is experimental drug being accessible to as many people as possible as soon as possible, you should advocate for the option to bypass the regulator and letting the people decide for themselves.
Do not advocate for corrupting the regulator.
> In the EU this regulatory pause of AZ has likely killed thousands of people.
I don't know how you came to that conclusion, but even if so, how many thousands of people would be eventually harmed or killed if the pause wasn't introduced? We don't know, because we are discovering properties and effects of the vaccines on the go. The data and estimates we have are based on short-term experience with the vaccines. They will change.
In treating people for illness it is a long established rule that "first, do no harm". And vaccine does not even help the patient with any illness - it is rather to help in case the patient would get one in the future. For many people, getting vaccinated has zero to negative benefit.
Nobody is entitled to get a fast-tracked rubber stamp to push vaccines on people. If you want to take experimental drugs, I support your right to do so, however I expect you let other people decide for themselves, including the regulators.
Why is the correct solution not to support people enough that the only reason anyone has to interact is to do "essential" work--for which the they should be paid hazard-level pay--and then do this slowly and carefully? We can offer the vaccine to people who would then feel better taking it--particularly if it means they get to make hazard-level pay--but it wouldn't matter if people didn't: the main risk of getting covid should be "I decided to interact with people, knowing the risks", and it isn't our job to prevent them from getting ill any more than it is our job to police peoples' home lives. This whole "the sky is falling" emergency scenario is a false dichotomy we have constructed to avoid actually staring at the problem of wage slavery :(.
Sadly, this is the case. The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. In the EU this regulatory pause of AZ has likely killed thousands of people.
> The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.
Or, more generally, in the emergency-order regime, all decisions that can demonstrate a clear 10:1 improvement in expected deaths should be taken, regardless of regulatory red tape.
The FDA and other regulators have over-fitted their process for "minimize likelihood of another Thalidomide, for drugs which have a small chance of saving a life, and a very small chance of causing harm". This is defensible for testing a new statin, where we have existing safe drugs to choose from, and we're looking for incremental improvements. But it's shockingly harmful in an emergency.
One thing that has become very clear is that the FDA and other regulators are structurally incapable of making even rudimentary risk-based tradeoffs in emergency situations, and we need to fix this.