4 ms·

Somehow I can't help but read you've smuggled endorsement for: It's ok if the product is more dangerous when bundled with the benefit that we can blame it on so

Somehow I can't help but read you've smuggled endorsement for: It's ok if the product is more dangerous when bundled with the benefit that we can blame it on some organization.

Infinitesimus 8y ago
The more generous interpretation is: We value life and try to reduce the risk of severe damage when making drugs. And regulatory bodies exist to combat the incentive to just ship whatever works without adequate regard for what could go wrong
- dekhn 8y ago
  Yes, this is what I meant. Thanks for being generous.
candiodari 8y ago
And what do you suggest we do when an open-source "biohack" results in something like this ? https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide Note the mistake made, and just how subtle it was. During testing a somewhat more ad-hoc process was used to produce the drug that did not result in the bad isomere, and then it was sold with multiple isomeres in the actual drug. Regulators at the time thought that isomeres did not matter and it took years for the effects to become clear. Of course regulators did not test for things they didn't know about. Neither did the companies (not just one). Crucially the drug was NOT tested for the effect on pregnancies (and was therefore not to be taken by pregnant women, like many drugs and even some non-drug products like famously alcohol). Furthermore: there is at least some amount of "guilt" on the part of some of the mothers: the medicine was NOT approved for use during pregnancy, and stated this. Result: >10.000 crippled children. Where is the guilt to be placed for this incident ? I would argue that the primary guilt is with the regulator (government) and a small amount with (most of) the mothers for taking unapproved medicine, with the rest of the mothers following doctors' prescriptions (which of course means those doctors prescribed unapproved medicine). Needless to say, the company was blamed, and forced to pay (essentially in trade for not going to prison). The German government denied any responsibility, and several other governments (famously Spain) went further: they denied anything had happened at all. So let's say there is a timing bug in this "open source pancreas", and it starts pumping insulin into the patients bodies without cause, say at the unix epoch transition. I would guess that at least half of them won't survive. What happens next ? Given the Thalomide incident we can make an educated guess: whatever the law says, and despite patients "accepting the risk", even when the patients explicitly make mistakes in the treatment, you can bet the government will go after whoever they can arrest, and force them to pay millions of euros, or throw them in jail for the rest of their life. People cannot be trusted to accept responsibility for the result of picking their own treatments, even when fully informed about the risks.
- dekhn 8y ago
  I have to add: Thalidomide is still prescribed today as it is a very effective drug. Also, as a response, the US has a much stronger system for evaluating drug safety.
  - daveguy 8y ago
    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.
shriver 8y ago
That's not the endorsement. The endorsement is that it's okay for a single product to be suboptimal as long as the system is optimal. It's more optimal to prevent or slow down a number of innovations in order to protect the vast majority of people from the sort of mistakes and scams that other industries accept as standard.

Somehow I can't help but read you've smuggled endorsement for: It's ok if the product is more dangerous when bundled with the benefit that we can blame it on some organization.

Infinitesimus 8y ago

The more generous interpretation is: We value life and try to reduce the risk of severe damage when making drugs. And regulatory bodies exist to combat the incentive to just ship whatever works without adequate regard for what could go wrong

dekhn 8y ago
Yes, this is what I meant. Thanks for being generous.

candiodari 8y ago

And what do you suggest we do when an open-source "biohack" results in something like this ? https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide Note the mistake made, and just how subtle it was. During testing a somewhat more ad-hoc process was used to produce the drug that did not result in the bad isomere, and then it was sold with multiple isomeres in the actual drug. Regulators at the time thought that isomeres did not matter and it took years for the effects to become clear. Of course regulators did not test for things they didn't know about. Neither did the companies (not just one). Crucially the drug was NOT tested for the effect on pregnancies (and was therefore not to be taken by pregnant women, like many drugs and even some non-drug products like famously alcohol). Furthermore: there is at least some amount of "guilt" on the part of some of the mothers: the medicine was NOT approved for use during pregnancy, and stated this. Result: >10.000 crippled children. Where is the guilt to be placed for this incident ? I would argue that the primary guilt is with the regulator (government) and a small amount with (most of) the mothers for taking unapproved medicine, with the rest of the mothers following doctors' prescriptions (which of course means those doctors prescribed unapproved medicine). Needless to say, the company was blamed, and forced to pay (essentially in trade for not going to prison). The German government denied any responsibility, and several other governments (famously Spain) went further: they denied anything had happened at all. So let's say there is a timing bug in this "open source pancreas", and it starts pumping insulin into the patients bodies without cause, say at the unix epoch transition. I would guess that at least half of them won't survive. What happens next ? Given the Thalomide incident we can make an educated guess: whatever the law says, and despite patients "accepting the risk", even when the patients explicitly make mistakes in the treatment, you can bet the government will go after whoever they can arrest, and force them to pay millions of euros, or throw them in jail for the rest of their life. People cannot be trusted to accept responsibility for the result of picking their own treatments, even when fully informed about the risks.

dekhn 8y ago
I have to add: Thalidomide is still prescribed today as it is a very effective drug. Also, as a response, the US has a much stronger system for evaluating drug safety.
- daveguy 8y ago
  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.

shriver 8y ago

That's not the endorsement. The endorsement is that it's okay for a single product to be suboptimal as long as the system is optimal. It's more optimal to prevent or slow down a number of innovations in order to protect the vast majority of people from the sort of mistakes and scams that other industries accept as standard.