5 ms·

If this cancer therapy ever makes it into US healthcare I will be amazed. There's too little profit to fund clinical trials and FDA approval. US residents coul

If this cancer therapy ever makes it into US healthcare I will be amazed. There's too little profit to fund clinical trials and FDA approval. US residents could perhaps travel abroad for the treatment. Maybe it will be offered in Mexico some day.

microcolonel 9y ago
> There's too little profit to fund clinical trials and FDA approval. People think they can have their cake and eat it too with the FDA. The administration likely kills many people through opportunity cost. People really need to ask themselves if the FDA are the ones who should be making the decision whether something is risky enough that you shouldn't have access to it. In my eyes, if drug companies had standard product liability, then drugs would be safer and cheaper.
- cgb223 9y ago
  Wasn't there a law passed fairly recently that allows otherwise terminal patients to try risky not-yet-approved treatments?
- falcolas 9y ago
  Just remember: the FDA is also the organization that keeps homeopathy from marketing itself as legitimate cure to every disease out there. For every potentially legitimate treatment held back, a hundred illegitimate - if not harmful - treatments are also stopped. I won't claim this excuses the costs and time associated with getting FDA approval, but it's one more thing to consider when judging them.
  - microcolonel 9y ago
    > Just remember: the FDA is also the organization that keeps homeopathy from marketing itself as legitimate cure to every disease out there. Who cares? Homeopathy is largely harmless, the vast majority of people who practice it are not actually treating anything. Unless something goes seriously wrong, an extreme dilution is not going to have the same devastating effect as an untreated serious condition, unless the patient sticks it out like a fool, in which case can anyone except the charlatan who convinced them really be blamed?
    - MaulingMonkey 9y ago
      > Who cares? Homeopathy is largely harmless, Not if someone is relying on it (or other 'harmless' cures like faith healing) to treat their cancer, or their children's cancer, instead of something that will actually work it's not. Nor is it harmless if they have a contagious condition that they spread around (and you catch!) under the assumption that they've already been 'cured'. Nor is it harmless even if it's just emptying their wallet. > Unless something goes seriously wrong, an extreme dilution is not going to have the same devastating effect as an untreated serious condition Which I'd wager you'd agree happens more often than homeopathy goes seriously right, even ignoring the fool patients, parents, and caregivers who might leave serious conditions effectively untreated on account of believing in snake oil. Not ignoring them, this was reported two days ago: https://arstechnica.com/science/2017/09/cdc-homeopathic-healing-bracelet-poisons-baby-with-high-levels-of-lead/ https://arstechnica.com/science/2017/09/cdc-homeopathic-heal... > in which case can anyone except the charlatan who convinced them really be blamed? Some would argue that the society which stood idly by and refused to oppose such charlatans, if not to blame, is at least some kind of low trust, everyone for themselves, shitty kind of society. Especially if it can identify who is to blame, and still does nothing. Government regulation is not the only tool of opposition. James Randi has given some good talks to help fight the ignorance they exploit with knowledge. (EDIT: His TED talk: https://www.youtube.com/watch?v=c0Z7KeNCi7g https://www.youtube.com/watch?v=c0Z7KeNCi7g .) And there's some arguments that can be made that true freedom requires freedom to do stupid, counterproductive, self harming shit (although that's not the argument you're making.) TL;DR: I disagree with you on your stance of how harmless homeopathy supposedly is.
    - Pica_soO 9y ago
      Fools have no right to live then? Now imagine a creature, very intelligent, but due to the intelligence - emotionally and socially handicapped- and thus unable to procreate. Such a creature would be foolish, thinking in evolutionary terms. But such a creature, could be useful for a society, who would want them to stick around. So if a not-fool would pro-create with such a fuel, even if it is rare, that would be a nice little selection machine. So if a procreation-fool, has foolish children, who in turn spawn procreation-fools, what a nice little dessert flower symbiosis that would be. And that is why intelligent people could have dumb children. The moral to this story: That fool clinging with cancer to charlatans, like Steve Jobs did- could be your future daughter or son. With great intelligence, comes great responsibility for those who might not wield it. And the uncomfortable knowledge that seemingly foolish behavior might be intelligent for other applications.
  - inimino 9y ago
    Is the ban on marketing really changing anyone's mind? I don't think anyone interested in homeopathy is likely to be put off by the fact that the FDA doesn't approve of it.
    - Sacho 9y ago
      It's stopping desperate people who have never heard of homeopathy from trying it, getting the placebo effect and becoming true believers.
  - u801e 9y ago
    > Just remember: the FDA is also the organization that keeps homeopathy from marketing itself as legitimate cure to every disease out there. On a related note, why are pharmaceutical companies allowed to market drugs through television and print advertisements? Clearly, most of the target population doesn't have the necessary knowledge or resources to make an informed decision regarding whether or not they should be on the advertised drug as part of their treatment.
    - refurb 9y ago
      DTC is allowed because the FDA has found the benefits outweigh the risk. Here is one positive data point of many in the physician survey: DTC ads help patients have better discussions with their physicians and provide greater awareness of treatments. The study demonstrated that when a patient asked about a specific drug, 88 percent of the time they had the condition that the drug treated. And 80 percent of physicians believed their patients understood what condition the advertised drug treats.[1] [1]https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143562.htm https://www.fda.gov/drugs/resourcesforyou/consumers/ucm14356...
      - falcolas 9y ago
        I won't disagree that this could be an upside, but it's interesting that the US is one of two countries which allow this kind of advertisement.
        sitharus 9y ago
        And the other doesn't get in to it anywhere near as much as the US because most of the time you get what is subsidised.
    - dboreham 9y ago
      Because: money (Very, very large quantities of it)
- adrianN 9y ago
  I don't think the average person has the time or the skill to make an accurate assesment of the level of risk that taking some experimental drug means for them. Especially if you get rid of the need to have long and expensive studies to prove safety. How is a patient supposed to make an informed decision?
  - SAI_Peregrinus 9y ago
    Also keep in mind that the studies to prove safety are the short and cheap ones (phases 1 & 2), the long and expensive one (phase 3) is to prove efficacy. Of course sometimes safety issues show up only in phase 3, but its primary purpose is to show that the drug actually works and isn't just a scam.
    - wbl 9y ago
      Safety is related to effacity. Have an oncology drug that makes you go deaf but extends life for melanoma patients by a lot? Great! Oh, it's for acne? Probably not going to pass muster.
  - gozur88 9y ago
    Just because the government doesn't make the decision for you doesn't mean you won't have information. There's no reason the FDA couldn't still exist as an advisory body.

microcolonel 9y ago

> There's too little profit to fund clinical trials and FDA approval. People think they can have their cake and eat it too with the FDA. The administration likely kills many people through opportunity cost. People really need to ask themselves if the FDA are the ones who should be making the decision whether something is risky enough that you shouldn't have access to it. In my eyes, if drug companies had standard product liability, then drugs would be safer and cheaper.

cgb223 9y ago
Wasn't there a law passed fairly recently that allows otherwise terminal patients to try risky not-yet-approved treatments?
falcolas 9y ago
Just remember: the FDA is also the organization that keeps homeopathy from marketing itself as legitimate cure to every disease out there. For every potentially legitimate treatment held back, a hundred illegitimate - if not harmful - treatments are also stopped. I won't claim this excuses the costs and time associated with getting FDA approval, but it's one more thing to consider when judging them.
- microcolonel 9y ago
  > Just remember: the FDA is also the organization that keeps homeopathy from marketing itself as legitimate cure to every disease out there. Who cares? Homeopathy is largely harmless, the vast majority of people who practice it are not actually treating anything. Unless something goes seriously wrong, an extreme dilution is not going to have the same devastating effect as an untreated serious condition, unless the patient sticks it out like a fool, in which case can anyone except the charlatan who convinced them really be blamed?
  - MaulingMonkey 9y ago
    > Who cares? Homeopathy is largely harmless, Not if someone is relying on it (or other 'harmless' cures like faith healing) to treat their cancer, or their children's cancer, instead of something that will actually work it's not. Nor is it harmless if they have a contagious condition that they spread around (and you catch!) under the assumption that they've already been 'cured'. Nor is it harmless even if it's just emptying their wallet. > Unless something goes seriously wrong, an extreme dilution is not going to have the same devastating effect as an untreated serious condition Which I'd wager you'd agree happens more often than homeopathy goes seriously right, even ignoring the fool patients, parents, and caregivers who might leave serious conditions effectively untreated on account of believing in snake oil. Not ignoring them, this was reported two days ago: https://arstechnica.com/science/2017/09/cdc-homeopathic-healing-bracelet-poisons-baby-with-high-levels-of-lead/ https://arstechnica.com/science/2017/09/cdc-homeopathic-heal... > in which case can anyone except the charlatan who convinced them really be blamed? Some would argue that the society which stood idly by and refused to oppose such charlatans, if not to blame, is at least some kind of low trust, everyone for themselves, shitty kind of society. Especially if it can identify who is to blame, and still does nothing. Government regulation is not the only tool of opposition. James Randi has given some good talks to help fight the ignorance they exploit with knowledge. (EDIT: His TED talk: https://www.youtube.com/watch?v=c0Z7KeNCi7g https://www.youtube.com/watch?v=c0Z7KeNCi7g .) And there's some arguments that can be made that true freedom requires freedom to do stupid, counterproductive, self harming shit (although that's not the argument you're making.) TL;DR: I disagree with you on your stance of how harmless homeopathy supposedly is.
  - Pica_soO 9y ago
    Fools have no right to live then? Now imagine a creature, very intelligent, but due to the intelligence - emotionally and socially handicapped- and thus unable to procreate. Such a creature would be foolish, thinking in evolutionary terms. But such a creature, could be useful for a society, who would want them to stick around. So if a not-fool would pro-create with such a fuel, even if it is rare, that would be a nice little selection machine. So if a procreation-fool, has foolish children, who in turn spawn procreation-fools, what a nice little dessert flower symbiosis that would be. And that is why intelligent people could have dumb children. The moral to this story: That fool clinging with cancer to charlatans, like Steve Jobs did- could be your future daughter or son. With great intelligence, comes great responsibility for those who might not wield it. And the uncomfortable knowledge that seemingly foolish behavior might be intelligent for other applications.
- inimino 9y ago
  Is the ban on marketing really changing anyone's mind? I don't think anyone interested in homeopathy is likely to be put off by the fact that the FDA doesn't approve of it.
  - Sacho 9y ago
    It's stopping desperate people who have never heard of homeopathy from trying it, getting the placebo effect and becoming true believers.
- u801e 9y ago
  > Just remember: the FDA is also the organization that keeps homeopathy from marketing itself as legitimate cure to every disease out there. On a related note, why are pharmaceutical companies allowed to market drugs through television and print advertisements? Clearly, most of the target population doesn't have the necessary knowledge or resources to make an informed decision regarding whether or not they should be on the advertised drug as part of their treatment.
  - refurb 9y ago
    DTC is allowed because the FDA has found the benefits outweigh the risk. Here is one positive data point of many in the physician survey: DTC ads help patients have better discussions with their physicians and provide greater awareness of treatments. The study demonstrated that when a patient asked about a specific drug, 88 percent of the time they had the condition that the drug treated. And 80 percent of physicians believed their patients understood what condition the advertised drug treats.[1] [1]https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143562.htm https://www.fda.gov/drugs/resourcesforyou/consumers/ucm14356...
    - falcolas 9y ago
      I won't disagree that this could be an upside, but it's interesting that the US is one of two countries which allow this kind of advertisement.
      - sitharus 9y ago
        And the other doesn't get in to it anywhere near as much as the US because most of the time you get what is subsidised.
  - dboreham 9y ago
    Because: money (Very, very large quantities of it)
adrianN 9y ago
I don't think the average person has the time or the skill to make an accurate assesment of the level of risk that taking some experimental drug means for them. Especially if you get rid of the need to have long and expensive studies to prove safety. How is a patient supposed to make an informed decision?
- SAI_Peregrinus 9y ago
  Also keep in mind that the studies to prove safety are the short and cheap ones (phases 1 & 2), the long and expensive one (phase 3) is to prove efficacy. Of course sometimes safety issues show up only in phase 3, but its primary purpose is to show that the drug actually works and isn't just a scam.
  - wbl 9y ago
    Safety is related to effacity. Have an oncology drug that makes you go deaf but extends life for melanoma patients by a lot? Great! Oh, it's for acne? Probably not going to pass muster.
- gozur88 9y ago
  Just because the government doesn't make the decision for you doesn't mean you won't have information. There's no reason the FDA couldn't still exist as an advisory body.