4 ms·

US regulators did not approve thalomide until after the risks were known. Their system for evaluating drug safety is the strongest in the world and that is why

US regulators did not approve thalomide until after the risks were known. Their system for evaluating drug safety is the strongest in the world and that is why there were no thalomide induced birth defects in the US. Those problems, subtleties and failures of regulation were in European markets where thalomide was approved more quickly (and new manufacturing processes were less closely regulated than the drug itself). EU has stronger regulatory practices in place as a result.

dekhn 8y ago
The narrative is more complicated than that, see https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey and https://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/ https://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-af.... In particular: athough Kelsey did correctly identify issues, there wasn't legal support for that kind of regulation until her work led to https://en.wikipedia.org/wiki/Kefauver_Harris_Amendment https://en.wikipedia.org/wiki/Kefauver_Harris_Amendment which was necessary legal support for the FDA regulation process.
- candiodari 8y ago
  True, but the point is more about that the government (and the people) went after the producer of the drug, despite that producer not really having screwed up, and left the ones that had screwed up (state, mothers and doctors) alone. Furthermore, the law did not really support these cases. But when you cripple 10.000 babies, law does not matter. Plus we all know they went after the company, not because it was at fault, but because they could band together against it. If that were to happen to an open source project (and that seems a reasonable guess for open source "biohacks"/medicine when they screw up) ... the authors will go to jail for life and die bankrupt. It doesn't matter what license, it doesn't matter what contracts say, it wouldn't even matter if you have personal videos of every user saying they will never hold you responsible with a paper around it signed in blood by both the user and a public notary. THAT's why we have the pharmaceutical industry we have.

dekhn 8y ago

The narrative is more complicated than that, see https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey and https://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/ https://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-af.... In particular: athough Kelsey did correctly identify issues, there wasn't legal support for that kind of regulation until her work led to https://en.wikipedia.org/wiki/Kefauver_Harris_Amendment https://en.wikipedia.org/wiki/Kefauver_Harris_Amendment which was necessary legal support for the FDA regulation process.

candiodari 8y ago
True, but the point is more about that the government (and the people) went after the producer of the drug, despite that producer not really having screwed up, and left the ones that had screwed up (state, mothers and doctors) alone. Furthermore, the law did not really support these cases. But when you cripple 10.000 babies, law does not matter. Plus we all know they went after the company, not because it was at fault, but because they could band together against it. If that were to happen to an open source project (and that seems a reasonable guess for open source "biohacks"/medicine when they screw up) ... the authors will go to jail for life and die bankrupt. It doesn't matter what license, it doesn't matter what contracts say, it wouldn't even matter if you have personal videos of every user saying they will never hold you responsible with a paper around it signed in blood by both the user and a public notary. THAT's why we have the pharmaceutical industry we have.