3 ms·
> What's unclear is not the data but the decisions they made based on the data. Why is that first-day margin of error acceptable for European diabetics but not
by daveFNbuck 9y ago
> What's unclear is not the data but the decisions they made based on the data. Why is that first-day margin of error acceptable for European diabetics but not American ones?
The decisions were being made by different people. It's not like the FDA decided that Americans require a 12-hour window but Europeans only need 1. The FDA is just more cautious.
- ng12 9y agoI wasn't being literal. The point is the FDA is overly cautious to the point that they're harming the health of patients. Slight deviations between the US and EU are understandable, 10x is questionable.
- daveFNbuck 9y agoI'm sure there are people who would say that European regulators are being permissive to the point that they're harming the health of patients. A lot of women in the US could have benefited from thalidomide while it was being used in Europe, but the FDA was too cautious to allow it. People will benefit from those extra 11 hours, but they'll also be hurt by the lower accuracy. It's completely reasonable for different people to weigh these costs and benefits differently.
- ng12 9y ago> People will benefit from those extra 11 hours, but they'll also be hurt by the lower accuracy 11 hours without a CGM is a much greater risk than marginally lower accuracy. As a potential user of this system I've been unable to locate research to convince me otherwise.
- daveFNbuck 9y agoLuckily there are other ways to get them, and the FDA's decision has kept you using a more accurate one.