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>>the TSA has never caught an actual terrorist. The FDA has stopped potentially harmful and/or ineffective drugs from coming to market<< This is an excellent e

by liber8 13y ago

>>the TSA has never caught an actual terrorist. The FDA has stopped potentially harmful and/or ineffective drugs from coming to market<< This is an excellent example of the "seen" vs. the "unseen". Sure, the FDA has stopped harmful and/or ineffective drugs from coming to market. But the FDA has also stopped plenty of effective drugs from coming to market, both directly (e.g. no more Vioxx because it might slightly elevate your risk of heart attack) and indirectly (the billions of dollars it costs, directly due to FDA requirements, to bring a drug to market). Is the assurance that FDA-approved drugs are safe[1] worth the inhibited advancement of medicine? I don’t know, but I doubt it. I think a much wiser approach would be to have potential drugs freely available, and subject to testing by third or quasi-third parties (ala Underwriters Laboratories). Hell, you could even leave the FDA in place if you want to, only limit its ability to restrict drugs to market. For example, you could reverse their decision-making criteria: FDA will only pull drugs from market if it can be shown that the drugs are more harmful than beneficial for their intended use. This would leave the choice to use a certain medication to individuals and their doctors, with guidance from FDA/labs who conduct the same sort of testing the FDA does now. [1] Note that the FDA’s stamp isn’t really an “assurance” anyway. Vioxx (and loads of other “harmful” drugs) still made it to market.

deleted 13y ago
[deleted]
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.

by liber8 13y ago

deleted 13y ago

[deleted]

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.