[dcolkitt]

The FDA's continual foot dragging on approving AstraZeneca is criminal. The UK has already thoroughly reviewed it and decided it was safe for approval. Is there any reason to believe that British scientists are any less competent than their American counterparts?

If the trials were successful in the UK, it's a complete waste of time to insist that they be duplicated in the US. Especially when thousands die every day. It's not like biology works different in the Western Hemisphere. This is just another example of bureaucrats flexing their power to aggrandize their own importance.

[armada651]

The FDA's continual foot dragging on approving Thalidomide is criminal. West Germany has already thoroughly reviewed it and decided it was safe for approval. Is there any reason to believe that German scientists are any less competent than their American counterparts?

Frances Kelsey is just another example of bureaucrats flexing their power to aggrandize their own importance.

[andrei_says_]

You forgot the /s and that may be confusing to many.

Frances Kelsey refused to approve the drug despite immense pressure to do so, and thus prevented releasing a drug causing birth defects.

[dcolkitt]

Covid kills more people every day than the entire number of birth defects caused by thalidomide in its entire history. Maybe it's time to start living in the here and now, instead of worrying about a minor incident from more than half a century ago. It's easy to count type I errors, now actually make an effort to quantify that against the countless number of type II errors.

I'm willing to bet you any amount up to $10,000 that AstraZeneca vaccine does not result in more than ten thousand deaths worldwide within the next two years. You clearly believe otherwise, since you think it's prudent for the FDA not to approve it. If you're not willing to risk your money, why are you willing to risk people's lives? Do you accept?

[skadamou]

Here is a good article that explains how drug approval is different in the US from Europe/UK [1]. Basically, the FDA has a reputation for being more thorough and for not taking the drug companies at their word and instead looking at the raw data from their trials. IDK if that is the best approach for approving the AstraZeneca vaccine but as this article explains, the FDAs approach did prevent thalidomide from being used in the US which was later found to cause birth defects in Europe and Canada.

[1] https://www.theguardian.com/world/2020/dec/04/how-vaccine-ap...

[dcolkitt]

Thalidomide occurred more than fifty years ago. Do you think it's maybe possible that medical science has advanced a little bit since then?

Also the total number of birth defects that thalidomide ever caused over its entire lifecycle, is less than the number of Covid deaths per day. Relative to the number of lives that hang in the balance, thalidomide is a rounding error, and shouldn't be considered.

On net, there's absolutely zero evidence that European drug approval is dangerous vis-a-vis the US. European healthcare systems produce much better outcomes than the US. And they have for decades.

[the-dude]

Does it really matter? Does AZ have production locations in the US?

Because their production schedule is behind on their orders for the UK and the EU.