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Nothing's an absolute assurance, mistakes happen in all walks of life. If you're talking about streamlining the FDA process without significantly increasing th

by jbooth 13y ago

Nothing's an absolute assurance, mistakes happen in all walks of life. If you're talking about streamlining the FDA process without significantly increasing the risk of harmful drugs slipping through, I think everybody's in favor of that. If you're talking about streamlining the process at the cost of higher risk, then that's probably a nonstarter. Why? I (and most people) am not willing to increase my odds of being harmed on behalf of someone else's profit margin. You'd have to be crazy to accept that deal. Expecting the market to 'just do your research' on drugs is crazy. It takes experts with PhDs a long time to verify a drug as safe, and they still make mistakes sometimes as you indicated... you're expecting me to do it? I haven't taken chemistry since high school.

dllthomas 13y ago
"If you're talking about streamlining the process at the cost of higher risk, then that's probably a nonstarter." For me that's not a non-starter. It's the start of a process that involves looking at just how much money gets saved (and by whom), just how much additional risk is borne by those taking the passed medications, and how much faster we're getting new (safe enough and effective enough) drugs on the market.
- jbooth 13y ago
  I should have slid in the word 'significantly' like I did in the previous sentence. You're willing to take significantly more risk that a routine drug prescription harms/kills you in order to streamline the process for drug companies? (Note that there already is a process in place for those with advanced diseases that justify a high-risk drug to take experimental drugs with knowledge of the risks).
  - dllthomas 13y ago
    Without pinning things down quite a bit more into specific proposals, I'm not willing to do much of anything. I'm just saying that sometimes increased risk for decreased money and increased time can be a good trade-off, and any given proposal should be evaluated on its merits.
    - jbooth 13y ago
      Sure. If the proposal is "government is tyranny, abolish the FDA!", there aren't any merits, the proposal is fundamentally unserious and comes from a place of deliberate ignorance. That's the kind of idiocy I was objecting to. Any realistic proposal (as in, we have an idea of how much extra risk we're incurring) is going to have a lot of technical details and probably require a huge amount of research to justify it -- it's human lives that we're talking about here. The potential $ savings are big but that doesn't matter if you're dead. Like I said way upthread, there is plenty of room for improvement, but "libertarian pixie dust will make everything better automatically" is the same thought process that led to collective farming and killing 10s of millions in Russia and China.
      - dllthomas 13y ago
        Savings doesn't matter if you're dead, but the other side can't be ignored either. If those billions permits more competition and leads to new drugs, that too can save lives. We need to do what we think is most likely to lead to the best outcome. There's a point beyond which that's no longer "more research", at which point researching more isn't taking it seriously. I have no particularly strong feelings about just where we are in that space - I'm busy saving the world along other lines.
liber8 13y ago
>>If you're talking about streamlining the process at the cost of higher risk, then that's probably a nonstarter.<< I hate to be that guy, but this is the fallacy of false dilemma, and directly ignores the example I gave above. >>I (and most people) am not willing to increase my odds of being harmed on behalf of someone else's profit margin. You'd have to be crazy to accept that deal.<< This isn't the deal. Do you feel that your odds of harm from taking a supplement are significantly too high, since of course supplements are not currently regulated by the FDA or any other government body? Are people who takes supplements crazy? >>Expecting the market to 'just do your research' on drugs is crazy. It takes experts with PhDs a long time to verify a drug as safe, and they still make mistakes sometimes as you indicated... you're expecting me to do it? I haven't taken chemistry since high school.<< Why is it crazy to expect the market to do research? This happens with literally every other product available. There are thousands of organizations dedicated to reviewing automobiles, blenders, mattresses, and literally every product you can buy. If people voluntarily want to purchase medicine that has not been evaluated by the FDA or some other testing organization (as is currently the case with thousands of medical supplements that are for sale) why must those people be stopped? Again, the choices aren't FDA approval or no access. There are all sorts of solutions that could be implemented to both increase availability of medicine while still offering consumer protection. Yes, PhDs make mistakes, but that wasn’t the point of the Vioxx reference. Vioxx was a fantastic pain drug that worked for some people when nothing else would. And that drug was taken away because Vioxx might increase the risk of heart attack. While this may sound fine to you, it was devastating to many people who would have preferred even a large risk of heart attack rather than living with the pain eliminated by Vioxx. (Vioxx was thought to increase the incidence of heart attack a staggering 4 times in one study . . . from .1% to .4%) Again, nobody is expecting you to do your own research. But that shouldn't limit our options to (1) FDA approval or (2) no drugs for you.

by jbooth 13y ago

dllthomas 13y ago

"If you're talking about streamlining the process at the cost of higher risk, then that's probably a nonstarter." For me that's not a non-starter. It's the start of a process that involves looking at just how much money gets saved (and by whom), just how much additional risk is borne by those taking the passed medications, and how much faster we're getting new (safe enough and effective enough) drugs on the market.

jbooth 13y ago
I should have slid in the word 'significantly' like I did in the previous sentence. You're willing to take significantly more risk that a routine drug prescription harms/kills you in order to streamline the process for drug companies? (Note that there already is a process in place for those with advanced diseases that justify a high-risk drug to take experimental drugs with knowledge of the risks).
- dllthomas 13y ago
  Without pinning things down quite a bit more into specific proposals, I'm not willing to do much of anything. I'm just saying that sometimes increased risk for decreased money and increased time can be a good trade-off, and any given proposal should be evaluated on its merits.
  - jbooth 13y ago
    Sure. If the proposal is "government is tyranny, abolish the FDA!", there aren't any merits, the proposal is fundamentally unserious and comes from a place of deliberate ignorance. That's the kind of idiocy I was objecting to. Any realistic proposal (as in, we have an idea of how much extra risk we're incurring) is going to have a lot of technical details and probably require a huge amount of research to justify it -- it's human lives that we're talking about here. The potential $ savings are big but that doesn't matter if you're dead. Like I said way upthread, there is plenty of room for improvement, but "libertarian pixie dust will make everything better automatically" is the same thought process that led to collective farming and killing 10s of millions in Russia and China.
    - dllthomas 13y ago
      Savings doesn't matter if you're dead, but the other side can't be ignored either. If those billions permits more competition and leads to new drugs, that too can save lives. We need to do what we think is most likely to lead to the best outcome. There's a point beyond which that's no longer "more research", at which point researching more isn't taking it seriously. I have no particularly strong feelings about just where we are in that space - I'm busy saving the world along other lines.

liber8 13y ago

>>If you're talking about streamlining the process at the cost of higher risk, then that's probably a nonstarter.<< I hate to be that guy, but this is the fallacy of false dilemma, and directly ignores the example I gave above. >>I (and most people) am not willing to increase my odds of being harmed on behalf of someone else's profit margin. You'd have to be crazy to accept that deal.<< This isn't the deal. Do you feel that your odds of harm from taking a supplement are significantly too high, since of course supplements are not currently regulated by the FDA or any other government body? Are people who takes supplements crazy? >>Expecting the market to 'just do your research' on drugs is crazy. It takes experts with PhDs a long time to verify a drug as safe, and they still make mistakes sometimes as you indicated... you're expecting me to do it? I haven't taken chemistry since high school.<< Why is it crazy to expect the market to do research? This happens with literally every other product available. There are thousands of organizations dedicated to reviewing automobiles, blenders, mattresses, and literally every product you can buy. If people voluntarily want to purchase medicine that has not been evaluated by the FDA or some other testing organization (as is currently the case with thousands of medical supplements that are for sale) why must those people be stopped? Again, the choices aren't FDA approval or no access. There are all sorts of solutions that could be implemented to both increase availability of medicine while still offering consumer protection. Yes, PhDs make mistakes, but that wasn’t the point of the Vioxx reference. Vioxx was a fantastic pain drug that worked for some people when nothing else would. And that drug was taken away because Vioxx might increase the risk of heart attack. While this may sound fine to you, it was devastating to many people who would have preferred even a large risk of heart attack rather than living with the pain eliminated by Vioxx. (Vioxx was thought to increase the incidence of heart attack a staggering 4 times in one study . . . from .1% to .4%) Again, nobody is expecting you to do your own research. But that shouldn't limit our options to (1) FDA approval or (2) no drugs for you.