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> Build an opt-in society, ultimately outside the US, run by technology. Balaji Srinivasan is being considered to run the FDA. If chosen, he is expected to rad

> Build an opt-in society, ultimately outside the US, run by technology. Balaji Srinivasan is being considered to run the FDA. If chosen, he is expected to radically weaken its regulatory power, purportedly in the interests of promoting innovation in the pharma space. He's described it as the big enemy for any biotech innovator to overcome. When we have an opt-in healthcare system, people who are in perfectly good health will opt into favorable plans only they qualify for. Those born with expensive conditions or who develop a chronic illness won't be able to opt in, and will find themselves in a high risk pool paying hardship-tier premiums. When we have pharmaceutical companies opting into less stringent regulatory structures, even the most dangerous drugs will make it to clinical trials - to be tested by people who lack the ability to choose any other way of making a living. Pharma manufacturers will then base their prices on what they believe the highest tier of wealth will bear, ignoring the long tail of underinsured Americans. The problem with an opt-in society is that only some people get the privilege of opting in. It's an almost self-contradicting concept. Societies only hold together if their members don't favor exit. Members collectively recognize they're all on the same side, by way of the social contract they've entered into, and they know the rules need to be the same for everyone. A modicum of loyalty - in Hirschman's sense - is an absolute prerequisite for a group to be called a society. When it comes to our health, let's show some loyalty to our fellow Americans and use our voices, instead of fleeing the inconveniently poor and sick. The veil of ignorance hasn't come off yet, after all: if you get cancer tomorrow, you might well become one of them.

notgood 10y ago
But what if America health system has terminal cancer? What if it's already beyond repair because the ones in charge are already fused into the system? About the opt-in society, I think it can create rules to prevent the disadvantages you mention; for example by paying a percentage of your salary/profits instead of a fixed amount; or perhaps by taking -free of charge- one sick poor person for every 10 healthy ones that enter the system.
- etjossem 10y ago
  > taking -free of charge- one sick poor person for every 10 healthy ones that enter the system. This is a very rough way to put it, but it's a fantastic idea. Policymakers call this universal healthcare.
  - notgood 10y ago
    Certainly not what Americans currently call "universal healthcare"; if the system needs to pay $600 for a simple epi-pen is certain that such system would not work. It must be managed by people strongly against inflated prices (due economic incentives or otherwise)
    - etjossem 10y ago
      Fortunately, the same elected legislators who have the ability to pass universal healthcare also get to make changes to patent regulation. If they want to be fiscally responsible, and notice their budgets are losing tons of money to the EpiPens of the world, they'll suddenly be very interested in patent reform. These people need our votes, though.
      - AnimalMuppet 10y ago
        If you reform patents in that way, you get cheaper EpiPens, it's true. But if you reformed it that way a while ago, you would have no EpiPens, because the maker wouldn't have gone to the expense of developing and testing them without the protection of patents (and the hope of profit they bring). Without patents, you only make thin margins; that's not enough to pay for developing something like the EpiPen. Banning patents sounds good; it sounds like freeing technology from greedy capitalists. But in practice, it means freezing (or at least dramatically slowing) the development of new medical technology.
        notgood 10y ago
        Why not allow patents to last 5 years, or 10? So the economic incentive remains while it becomes affordable soon enough; the Epipen was created in the mid 70s, it makes no sense for it to still have an enforceable patent.
linuxkerneldev 10y ago
> purportedly in the interests of promoting innovation in the pharma space Why the purportedly? Do you have reason to believe he has any ulterior motives? I didn't know anything about this guy before this so I googled him. http://online.stanford.edu/instructors/balaji-s-srinivasan http://online.stanford.edu/instructors/balaji-s-srinivasan "the co-founder and CTO of Counsyl, a genomics startup" Ok, so he clearly has some experience as a biotech innovator. > He's described it as the big enemy for any biotech innovator to overcome. Seems reasonable. The current market in biotech and rate of innovation seems underwhelming. Would you agree? The current level of legislation in biotech seems to favor too-big-to-fail type companies? They sure seem to get away with egregious crimes. Eg: bribery [1] , knowingly selling HIV contaminated blood products , even moving such sales to Asia and Africa after it became public in the US [2] , numerous other ethical issues [3] [1] https://www.bloomberg.com/news/articles/2016-09-30/glaxo-to-pay-20-million-sec-fine-over-bribing-chinese-officials https://www.bloomberg.com/news/articles/2016-09-30/glaxo-to-... [2] https://www.ncbi.nlm.nih.gov/pubmed/24785997 https://www.ncbi.nlm.nih.gov/pubmed/24785997 [3] http://ethics.harvard.edu/pharmaceutical-industry-institutional-corruption-and-public-health http://ethics.harvard.edu/pharmaceutical-industry-institutio... Seems to me the current system isn't working properly. Is there reason to believe a guy like Baraji shouldn't be allowed to try to reform it?
yummyfajitas 10y ago
When we have an opt-in healthcare system, people who are in perfectly good health will opt into favorable plans only they qualify for. Those born with expensive conditions or who develop a chronic illness won't be able to opt in, and will find themselves in a high risk pool paying hardship-tier premiums. You write as if Srinivasan is being considered to run HHS/Obamacare. He's not. The FDA has nothing to do with health insurance. When we have pharmaceutical companies opting into less stringent regulatory structures, even the most dangerous drugs will make it to clinical trials - to be tested by people who lack the ability to choose any other way of making a living. I get the impression you want to remove this option from people, thereby giving them exactly zero ways to make a living. Is that correct? Pharma manufacturers will then base their prices on what they believe the highest tier of wealth will bear, ignoring the long tail of underinsured Americans. You seem very confused. The FDA does not currently regulate prices. However, FDA regulations do drive prices up and create a lot of monopolies in the pharmaceutical space. If you want to learn what Srinivasan might actually mean for the FDA, I strongly recommend reading this blog post (written by a Trump hater, FYI): http://slatestarcodex.com/2017/01/18/watch-new-health-picks/ http://slatestarcodex.com/2017/01/18/watch-new-health-picks/
- entee 10y ago
  Looking at this point and one of the ones below, I think there's a bit of a misunderstanding as to why drugs are expensive and why they take so long to get to market. The hypothesis Balaji and others here suggest is that the FDA requires drugmakers to pass useless onerous regulations and expensive studies before it'll approve a drug. In so doing, the drugs become more expensive to market. Having worked a little in the drug discovery area, I'd advance a different hypothesis: the low hanging fruit are gone. Balaji in his post explicitly mentions insulin coming to market in 2 years. That's a pretty easy thing to approve: you have a molecule that is identical to one produced by your own body, that has known or easily understood physiology and pharmacokinetics. All you have to show is that your preparation isn't toxic, so of course it's going to take nearly no time to get approved. Contrast with a cancer drug. There you have a really complicated disease, not very good model systems before you get to test the molecule in a human subject, and when you get there most of your patients die anyway because diseases are hard/they're too sick/it doesn't work well enough. I think the information/silicon technology side of silicon valley doesn't quite understand how hard biochemistry and biotech actually is. In traditional engineering you know a lot about the inputs to your system (code, silicon, plastic, etc.) and you know a lot about how they work. In Biology/Biochemistry/Physiology none of that is true. Your inputs, underlying system and outputs are hugely complex and in many ways completely non-understood. That's why it takes so long to "innovate" or develop new drugs. Bureaucracy may not help, but it's not the main cause either. An essential blog to read if interested in drug discovery: http://blogs.sciencemag.org/pipeline/ http://blogs.sciencemag.org/pipeline/ topic relevant post: http://blogs.sciencemag.org/pipeline/archives/2015/08/07/on-the-fda-drug-approvals-and-not-knowing-enough http://blogs.sciencemag.org/pipeline/archives/2015/08/07/on-... Full disclosure: I once met with Balaji for an informal job interview/get to know the company at Counsyl

notgood 10y ago

But what if America health system has terminal cancer? What if it's already beyond repair because the ones in charge are already fused into the system? About the opt-in society, I think it can create rules to prevent the disadvantages you mention; for example by paying a percentage of your salary/profits instead of a fixed amount; or perhaps by taking -free of charge- one sick poor person for every 10 healthy ones that enter the system.

etjossem 10y ago
> taking -free of charge- one sick poor person for every 10 healthy ones that enter the system. This is a very rough way to put it, but it's a fantastic idea. Policymakers call this universal healthcare.
- notgood 10y ago
  Certainly not what Americans currently call "universal healthcare"; if the system needs to pay $600 for a simple epi-pen is certain that such system would not work. It must be managed by people strongly against inflated prices (due economic incentives or otherwise)
  - etjossem 10y ago
    Fortunately, the same elected legislators who have the ability to pass universal healthcare also get to make changes to patent regulation. If they want to be fiscally responsible, and notice their budgets are losing tons of money to the EpiPens of the world, they'll suddenly be very interested in patent reform. These people need our votes, though.
    - AnimalMuppet 10y ago
      If you reform patents in that way, you get cheaper EpiPens, it's true. But if you reformed it that way a while ago, you would have no EpiPens, because the maker wouldn't have gone to the expense of developing and testing them without the protection of patents (and the hope of profit they bring). Without patents, you only make thin margins; that's not enough to pay for developing something like the EpiPen. Banning patents sounds good; it sounds like freeing technology from greedy capitalists. But in practice, it means freezing (or at least dramatically slowing) the development of new medical technology.
      - notgood 10y ago
        Why not allow patents to last 5 years, or 10? So the economic incentive remains while it becomes affordable soon enough; the Epipen was created in the mid 70s, it makes no sense for it to still have an enforceable patent.

linuxkerneldev 10y ago

> purportedly in the interests of promoting innovation in the pharma space Why the purportedly? Do you have reason to believe he has any ulterior motives? I didn't know anything about this guy before this so I googled him. http://online.stanford.edu/instructors/balaji-s-srinivasan http://online.stanford.edu/instructors/balaji-s-srinivasan "the co-founder and CTO of Counsyl, a genomics startup" Ok, so he clearly has some experience as a biotech innovator. > He's described it as the big enemy for any biotech innovator to overcome. Seems reasonable. The current market in biotech and rate of innovation seems underwhelming. Would you agree? The current level of legislation in biotech seems to favor too-big-to-fail type companies? They sure seem to get away with egregious crimes. Eg: bribery [1] , knowingly selling HIV contaminated blood products , even moving such sales to Asia and Africa after it became public in the US [2] , numerous other ethical issues [3] [1] https://www.bloomberg.com/news/articles/2016-09-30/glaxo-to-pay-20-million-sec-fine-over-bribing-chinese-officials https://www.bloomberg.com/news/articles/2016-09-30/glaxo-to-... [2] https://www.ncbi.nlm.nih.gov/pubmed/24785997 https://www.ncbi.nlm.nih.gov/pubmed/24785997 [3] http://ethics.harvard.edu/pharmaceutical-industry-institutional-corruption-and-public-health http://ethics.harvard.edu/pharmaceutical-industry-institutio... Seems to me the current system isn't working properly. Is there reason to believe a guy like Baraji shouldn't be allowed to try to reform it?

yummyfajitas 10y ago

When we have an opt-in healthcare system, people who are in perfectly good health will opt into favorable plans only they qualify for. Those born with expensive conditions or who develop a chronic illness won't be able to opt in, and will find themselves in a high risk pool paying hardship-tier premiums. You write as if Srinivasan is being considered to run HHS/Obamacare. He's not. The FDA has nothing to do with health insurance. When we have pharmaceutical companies opting into less stringent regulatory structures, even the most dangerous drugs will make it to clinical trials - to be tested by people who lack the ability to choose any other way of making a living. I get the impression you want to remove this option from people, thereby giving them exactly zero ways to make a living. Is that correct? Pharma manufacturers will then base their prices on what they believe the highest tier of wealth will bear, ignoring the long tail of underinsured Americans. You seem very confused. The FDA does not currently regulate prices. However, FDA regulations do drive prices up and create a lot of monopolies in the pharmaceutical space. If you want to learn what Srinivasan might actually mean for the FDA, I strongly recommend reading this blog post (written by a Trump hater, FYI): http://slatestarcodex.com/2017/01/18/watch-new-health-picks/ http://slatestarcodex.com/2017/01/18/watch-new-health-picks/

entee 10y ago
Looking at this point and one of the ones below, I think there's a bit of a misunderstanding as to why drugs are expensive and why they take so long to get to market. The hypothesis Balaji and others here suggest is that the FDA requires drugmakers to pass useless onerous regulations and expensive studies before it'll approve a drug. In so doing, the drugs become more expensive to market. Having worked a little in the drug discovery area, I'd advance a different hypothesis: the low hanging fruit are gone. Balaji in his post explicitly mentions insulin coming to market in 2 years. That's a pretty easy thing to approve: you have a molecule that is identical to one produced by your own body, that has known or easily understood physiology and pharmacokinetics. All you have to show is that your preparation isn't toxic, so of course it's going to take nearly no time to get approved. Contrast with a cancer drug. There you have a really complicated disease, not very good model systems before you get to test the molecule in a human subject, and when you get there most of your patients die anyway because diseases are hard/they're too sick/it doesn't work well enough. I think the information/silicon technology side of silicon valley doesn't quite understand how hard biochemistry and biotech actually is. In traditional engineering you know a lot about the inputs to your system (code, silicon, plastic, etc.) and you know a lot about how they work. In Biology/Biochemistry/Physiology none of that is true. Your inputs, underlying system and outputs are hugely complex and in many ways completely non-understood. That's why it takes so long to "innovate" or develop new drugs. Bureaucracy may not help, but it's not the main cause either. An essential blog to read if interested in drug discovery: http://blogs.sciencemag.org/pipeline/ http://blogs.sciencemag.org/pipeline/ topic relevant post: http://blogs.sciencemag.org/pipeline/archives/2015/08/07/on-the-fda-drug-approvals-and-not-knowing-enough http://blogs.sciencemag.org/pipeline/archives/2015/08/07/on-... Full disclosure: I once met with Balaji for an informal job interview/get to know the company at Counsyl