6 ms·

truly amazing. seems seriously unfortunate that it takes the FDA 7 years to approve a device like this. I wonder how much testing they actually spend and how mu

truly amazing. seems seriously unfortunate that it takes the FDA 7 years to approve a device like this. I wonder how much testing they actually spend and how much time is wasted in bureaucratic BS. regardless, the story is amazing and the device seems incredible

windsurfer 17y ago
Considering the worst case situation, if this is unsafe, to be death, and best case is a slightly better treatment, I think thorough testing and a long approval process is certainly in order.
- yummyfajitas 17y ago
  You would be right if it were an asthma or restless leg treatment. This is a cancer treatment. The worst case scenario is a slightly earlier death.
  - windsurfer 17y ago
    There are other treatments for cancer.
    - Novash 17y ago
      And very rarely they result in cure. Sometimes, they give you some years till recurrence kicks in. Mostly, they make your last years very miserable.
      - windsurfer 17y ago
        And this one does the same, as it's just a more localized version of chemo.
        briancooley 17y ago
        Is that verified? It seems to me that a localized version would be lees likely to cause nausea, hair loss, and the myriad other side effects of chemotherapy.
- anamax 17y ago
  > I think thorough testing and a long approval process is certainly in order. Huh? Suppose that it costs $1 and a quick test shows that it seems to help "a bit". Why not let folks skip a Coke for on the chance that the benefit is real while "thorough testing" goes on? Costs and benefits apply to testing as well as deployment.
  - praptak 17y ago
    "Suppose that it costs $1 and a quick test shows that it seems to help "a bit". Why not let folks skip a Coke for on the chance that the benefit is real while "thorough testing" goes on?" You missed the part about the worst case being death. What if using the device provides short term relief but makes 15 percent of patients die within half a year after its usage?
    - anamax 17y ago
      Nope. I read the response that pointed out that the worst case here was slightly earlier death and realized that in many cases the worst case is exactly what I said it was, someone is out the cost of a Coke. The fact that some medical "treatments" will kill you is not necessary useful when evaluating a different treatment. It's important to evaluate things based on their actual costs and benefits, not the costs and benefits of other things.
- jacoblyles 17y ago
  It has long been the contention of many economists that the incentive structure of the FDA is biased towards killing people through inaction (too strict approval) rather than killing people through too loose of approval standards. The FDA takes a lot more heat when someone dies from a drug they approve than when 100 people die from not having access to a drug that they drag their feet on.
duncanj 17y ago
If it's important to you, why not ask and find out?
akd 17y ago
The FDA, on the whole, is quite reasonable and well-run. For treatments where there isn't an alternative and the disease is fatal, they do accelerate approvals and they allow more people to use the drug experimentally. For things like Rogaine they are very cautious and even then sometimes make fatal mistakes.

windsurfer 17y ago

Considering the worst case situation, if this is unsafe, to be death, and best case is a slightly better treatment, I think thorough testing and a long approval process is certainly in order.

yummyfajitas 17y ago
You would be right if it were an asthma or restless leg treatment. This is a cancer treatment. The worst case scenario is a slightly earlier death.
- windsurfer 17y ago
  There are other treatments for cancer.
  - Novash 17y ago
    And very rarely they result in cure. Sometimes, they give you some years till recurrence kicks in. Mostly, they make your last years very miserable.
    - windsurfer 17y ago
      And this one does the same, as it's just a more localized version of chemo.
      - briancooley 17y ago
        Is that verified? It seems to me that a localized version would be lees likely to cause nausea, hair loss, and the myriad other side effects of chemotherapy.
anamax 17y ago
> I think thorough testing and a long approval process is certainly in order. Huh? Suppose that it costs $1 and a quick test shows that it seems to help "a bit". Why not let folks skip a Coke for on the chance that the benefit is real while "thorough testing" goes on? Costs and benefits apply to testing as well as deployment.
- praptak 17y ago
  "Suppose that it costs $1 and a quick test shows that it seems to help "a bit". Why not let folks skip a Coke for on the chance that the benefit is real while "thorough testing" goes on?" You missed the part about the worst case being death. What if using the device provides short term relief but makes 15 percent of patients die within half a year after its usage?
  - anamax 17y ago
    Nope. I read the response that pointed out that the worst case here was slightly earlier death and realized that in many cases the worst case is exactly what I said it was, someone is out the cost of a Coke. The fact that some medical "treatments" will kill you is not necessary useful when evaluating a different treatment. It's important to evaluate things based on their actual costs and benefits, not the costs and benefits of other things.
jacoblyles 17y ago
It has long been the contention of many economists that the incentive structure of the FDA is biased towards killing people through inaction (too strict approval) rather than killing people through too loose of approval standards. The FDA takes a lot more heat when someone dies from a drug they approve than when 100 people die from not having access to a drug that they drag their feet on.

duncanj 17y ago

If it's important to you, why not ask and find out?

akd 17y ago

The FDA, on the whole, is quite reasonable and well-run. For treatments where there isn't an alternative and the disease is fatal, they do accelerate approvals and they allow more people to use the drug experimentally. For things like Rogaine they are very cautious and even then sometimes make fatal mistakes.