8 ms·

It seems ridiculous to me that the FDA prevents scientists and doctors from getting known, proven anti-venom products back in the market, whereas the rich corpo

It seems ridiculous to me that the FDA prevents scientists and doctors from getting known, proven anti-venom products back in the market, whereas the rich corporations can get drugs on the market that still aren't proven to be much more effective than a placebo, but with worse side effects.

deleted 16y ago
[deleted]
pyre 16y ago
It seems like this would be an instance where the government should provide the funding. It's in the public's best interest to have at least one anti-venom product available. It makes no sense to tell people "tough luck" when they get bitten just because it's too expensive to pay for the studies to get government approval.
- earl 16y ago
  Well, until it has been tested, it is neither tried nor proven. And here is but a single reason http://en.wikipedia.org/wiki/Thalidomide http://en.wikipedia.org/wiki/Thalidomide for such testing requirements. Edit: to be clear, I was attempting to respond to the parent's parent post. I apparently suck at internet.
  - barrkel 16y ago
    The use case for an antivenom based on known working precedents, where the untreated alternative is death, is somewhat different to sedatives used generally to treat colds, coughs, morning sickness, etc.
    - earl 16y ago
      No. Read the article -- in the example used, the alternative is weeks on a ventilator. Which we know works. Until these drugs are known to be efficacious with tolerable side effects, they are still a second best treatment.
      - pyre 16y ago
        What if you are too far away from a facility that can provide that for you? Having a syringe of anti-venom with you can be the difference between life and death.
        evgen 16y ago
        There is no facility you will encounter that has the anti-venom but does not have a ventilator. This is not like an epi-pen or some other OTC med that a backpacker will carry with them, it is a hospital-dispensed, fucking expensive dose of medicine (e.g. rattlesnake anti-venom is around $4K/bottle.) But why let reality get in the way of a good rant I guess...
        pyre 16y ago
        How could you classify my comment as a rant? I realize that 'tone' doesn't really translate well through text and you might read my comment as an attack (which it wasn't), but how can a couple of sentences be a 'rant?' I would think that a rant would have to be at least a few sentences or more (or some sort of absolute character/word limit in the case of large run-on sentences). If you felt it was made in anger or hate, I would think it would classify as a retort or something similar.
  - pyre 16y ago
    > Edit: to be clear, I was attempting to respond to the parent's parent post. I apparently suck at internet. Something weird happened. When I originally posted, your comment was a sibling post to mine (and was already a child of the root of this thread after the page reload from submitting my comment). I was surprised when I came back to this thread to see your comment a child to my comment.
- Gormo 16y ago
  Or simply revoke the patent for these antivenoms so that companies that don't have the same opportunity costs can enter the niche. I think it would solve a lot of other problems (e.g. submarine patents) if patent holders were required (within defined bounds) to offer their patented products for sale on the open market in order to retain the patent.
  - brg 16y ago
    As much as you may be against software patents, there can be no current patent restriction on the production of coral-snake antivenom if it was approved in 1967. The problem described in the article is simply that so few bites occur, the effort to make antivenom is not interesting to anyone with the skills or equipment to make it. This includes individual pharmacists, university scientists, and corporations; all of who can but do not provide antivenom.
    - Gormo 16y ago
      That's a good point; I didn't make the connection with the 1967 date and focused on the article referencing that one company as the only source of antivenom. Is it possible for pharmacists to synthesize anti-venom on demand? Coral snake bites may be rare, but if you were, for example, the operator of an Everglades tour group, your probability of encountering a bite might be a bit higher, and the antivenom would be good to keep around.
      - sigstoat 16y ago
        you'd probably want an organic synthesis chemist, not a pharmacist. and you wouldn't have time for him to have the appropriate glassware fabricated, and synthesis equipment setup. so he'd have to leave a room with it all step up properly. ...which sounds like the sort of thing you might do if you were just manufacturing it.
        brg 16y ago
        Perhaps originally I should have said pharmacologist, but even in retrospect your term of a specialized chemist seems more correct.
elidourado 16y ago
My view is that people should be allowed to opt out of FDA regulation if they wish to do so. It's my body; I should be allowed to put anything I want into it. It took 10 years for the first beta blockers to be approved in the US after they were in use in Europe. In that amount of time, thousands of Americans died for lack of the drugs. It's hard to distinguish this from mass murder, or at least mass manslaughter.
- earl 16y ago
  And Thalidomide wasn't approved in the US whereas it was approved in Europe and Canada. So... your point is stupid.
  - deleted 16y ago
    [deleted]
  - jsn 16y ago
    No, it's not, but your point definitely is irrelevant. You see, it's my body, so I can put whatever I want in it, be it aspirin, heroin, thalidomide or cyanide. And yeah, I may wish to make an educated choice about that, but then again, I don't have to.
    - pyre 16y ago
      True, but when you're talking medicines, you may not have a choice in the matter. e.g. You come into the emergency room unconscious, what medicines should the doctors be allowed to use?
      - jsn 16y ago
        Basically, if someone is going to make a decision affecting my body while I'm unconscious, I'd rather have someone I picked for that job to do it (like, I don't know, my doctor or my wife or my dad or my friend or even my insurance company) than some bureaucrat in FDA. But that's not quite the issue in question, eh? My understanding is, you can't get the unapproved anti-venom even if you are conscious and you are about to die without it anyway, by doctors opinion.
Tichy 16y ago
There might be a connection, rich corporations benefit from costly approval procedures. Keeps the small competition at bay.

deleted 16y ago

[deleted]

pyre 16y ago

It seems like this would be an instance where the government should provide the funding. It's in the public's best interest to have at least one anti-venom product available. It makes no sense to tell people "tough luck" when they get bitten just because it's too expensive to pay for the studies to get government approval.

earl 16y ago
Well, until it has been tested, it is neither tried nor proven. And here is but a single reason http://en.wikipedia.org/wiki/Thalidomide http://en.wikipedia.org/wiki/Thalidomide for such testing requirements. Edit: to be clear, I was attempting to respond to the parent's parent post. I apparently suck at internet.
- barrkel 16y ago
  The use case for an antivenom based on known working precedents, where the untreated alternative is death, is somewhat different to sedatives used generally to treat colds, coughs, morning sickness, etc.
  - earl 16y ago
    No. Read the article -- in the example used, the alternative is weeks on a ventilator. Which we know works. Until these drugs are known to be efficacious with tolerable side effects, they are still a second best treatment.
    - pyre 16y ago
      What if you are too far away from a facility that can provide that for you? Having a syringe of anti-venom with you can be the difference between life and death.
      - evgen 16y ago
        There is no facility you will encounter that has the anti-venom but does not have a ventilator. This is not like an epi-pen or some other OTC med that a backpacker will carry with them, it is a hospital-dispensed, fucking expensive dose of medicine (e.g. rattlesnake anti-venom is around $4K/bottle.) But why let reality get in the way of a good rant I guess...
        pyre 16y ago
        How could you classify my comment as a rant? I realize that 'tone' doesn't really translate well through text and you might read my comment as an attack (which it wasn't), but how can a couple of sentences be a 'rant?' I would think that a rant would have to be at least a few sentences or more (or some sort of absolute character/word limit in the case of large run-on sentences). If you felt it was made in anger or hate, I would think it would classify as a retort or something similar.
- pyre 16y ago
  > Edit: to be clear, I was attempting to respond to the parent's parent post. I apparently suck at internet. Something weird happened. When I originally posted, your comment was a sibling post to mine (and was already a child of the root of this thread after the page reload from submitting my comment). I was surprised when I came back to this thread to see your comment a child to my comment.
Gormo 16y ago
Or simply revoke the patent for these antivenoms so that companies that don't have the same opportunity costs can enter the niche. I think it would solve a lot of other problems (e.g. submarine patents) if patent holders were required (within defined bounds) to offer their patented products for sale on the open market in order to retain the patent.
- brg 16y ago
  As much as you may be against software patents, there can be no current patent restriction on the production of coral-snake antivenom if it was approved in 1967. The problem described in the article is simply that so few bites occur, the effort to make antivenom is not interesting to anyone with the skills or equipment to make it. This includes individual pharmacists, university scientists, and corporations; all of who can but do not provide antivenom.
  - Gormo 16y ago
    That's a good point; I didn't make the connection with the 1967 date and focused on the article referencing that one company as the only source of antivenom. Is it possible for pharmacists to synthesize anti-venom on demand? Coral snake bites may be rare, but if you were, for example, the operator of an Everglades tour group, your probability of encountering a bite might be a bit higher, and the antivenom would be good to keep around.
    - sigstoat 16y ago
      you'd probably want an organic synthesis chemist, not a pharmacist. and you wouldn't have time for him to have the appropriate glassware fabricated, and synthesis equipment setup. so he'd have to leave a room with it all step up properly. ...which sounds like the sort of thing you might do if you were just manufacturing it.
      - brg 16y ago
        Perhaps originally I should have said pharmacologist, but even in retrospect your term of a specialized chemist seems more correct.

elidourado 16y ago

My view is that people should be allowed to opt out of FDA regulation if they wish to do so. It's my body; I should be allowed to put anything I want into it. It took 10 years for the first beta blockers to be approved in the US after they were in use in Europe. In that amount of time, thousands of Americans died for lack of the drugs. It's hard to distinguish this from mass murder, or at least mass manslaughter.

earl 16y ago
And Thalidomide wasn't approved in the US whereas it was approved in Europe and Canada. So... your point is stupid.
- deleted 16y ago
  [deleted]
- jsn 16y ago
  No, it's not, but your point definitely is irrelevant. You see, it's my body, so I can put whatever I want in it, be it aspirin, heroin, thalidomide or cyanide. And yeah, I may wish to make an educated choice about that, but then again, I don't have to.
  - pyre 16y ago
    True, but when you're talking medicines, you may not have a choice in the matter. e.g. You come into the emergency room unconscious, what medicines should the doctors be allowed to use?
    - jsn 16y ago
      Basically, if someone is going to make a decision affecting my body while I'm unconscious, I'd rather have someone I picked for that job to do it (like, I don't know, my doctor or my wife or my dad or my friend or even my insurance company) than some bureaucrat in FDA. But that's not quite the issue in question, eh? My understanding is, you can't get the unapproved anti-venom even if you are conscious and you are about to die without it anyway, by doctors opinion.

Tichy 16y ago

There might be a connection, rich corporations benefit from costly approval procedures. Keeps the small competition at bay.