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And who pays for the, potentially unbounded fallout from that decision ? Let's say this happens : http://en.wikipedia.org/wiki/Thalidomide http://en.wikipedia.

by waps 12y ago

And who pays for the, potentially unbounded fallout from that decision ? Let's say this happens : http://en.wikipedia.org/wiki/Thalidomide http://en.wikipedia.org/wiki/Thalidomide (First read about the advantages of the drug, then move to the crises. in particular the birth defects crisis) And please don't just say that people knowingly took the risk, read the article first to see how that played out. People won't accept the consequences of decisions made under duress (and this decision would be "death or we experiment on you". Decision to be made in an isolation camp, guarded by soldiers with guns), for obvious reasons, and this has been an accepted legal principle since a millenium before Jesus was born. You're suggesting just canceling it ? Really ? What you're suggesting is a really, really, really, really bad idea.

ng12 12y ago
I would argue there are at least a few orders of magnitude between someone with morning sickness and someone who will almost definitely die of Ebola or T1 Diabetes. It's a calculated risk, sure, but I don't think the Thalidomide example is particularly relevant.
- hueving 12y ago
  >It's a calculated risk, sure, but I don't think the Thalidomide example is particularly relevant. It's very relevant. It shows that people are too willing to take risks with major unknowns. Where do you make the cutoff with your drug experiments? Only people that are certain to die? People with high exposure risk? People that are having difficulties recovering? Any selection you pick there is completely arbitrary because you don't know the potential downsides to the experimental stuff you want to try.
  - ghshephard 12y ago
    "Where do you make the cutoff with your drug experiments? " I don't know where you make the cutoff, but I'm comfortable saying that its somewhere below having a disease with a 50% mortality rate in under 14 days. I'm pretty much okay taking any risk at that point.
    - Padding 12y ago
      You didn't get the point of the argument. What do you do when something with 51% mortality in 15 days comes up? And then something with 49% in 13 days .. where do you draw the line? And what do you do when people continue to cry out?
      - barrkel 12y ago
        The existence of a Sorites paradox doesn't mean that heaps and grains are not different things.
      - ghshephard 12y ago
        I got the point of the argument. And, I made it very clear that I don't know where to draw the line. All I know for sure, is that 50% mortality in 14 days comes below that line. Sign me up for an experimental treatment.
    - DanBC 12y ago
      What if the risk was survival but with locked-in syndrome and constant very high pain? Or survival but severely brain damaged - no ability to feed yourself; or talk; or understand the conversations of other people.
      - ctdonath 12y ago
        A risk? yes. But if that risk is significantly less than the other high-risk form of "severely brain damaged, unable to eat, talk, or understand" known as death, many would take it. Remember, the point is trying something that doctors & pharmacists believe has a sensible chance of actual _cure_ (perhaps with acceptable side effects better than death/dementia). I don't understand the propensity of some to demean "hey, there's a serious immediate problem, let's do everything we can to help" with "but it might (with minuscule odds) go horribly wrong! therefore we can't let anyone do anything that's not established best-condition status quo!" With that mindset, it's a wonder such people ever drive to work (you might die in a horrible flaming carbecue!). Statistical prioritization matters. Just because there isn't a perfect solution doesn't mean there isn't a better one.
narrator 12y ago
So you're suggesting that we let potentially hundreds of thousands of people die to prevent a potential tort lawsuit? Would you be ok if we shoot them if they try and leave the quarantine though to get an unapproved treatment? Do you see how crazy your logic is? The benefit of Thalidomide was that it prevented morning sickness and you're comparing that to treatment of a disease with a fatality rate of greater than 50%! You have no sense of proportion at all!
- lotsofmangos 12y ago
  It seems reasonably proportionate not to suspend all regulations on drug testing. If you did that then the vitamin peddlers out to make a fast buck would swamp anything that might actually help. The amount of con artists massively outnumbers the amount of people with a cure for Ebola. I agree that it may be an idea to look at trying some of the experimental treatments, however given there is a 50% chance of surviving with palliative care and that we know how to stop it spreading given the resources, I am not sure that turning the situation into an unregulated free-for-all for every quack looking to make their name will really help matters.
ekianjo 12y ago
Why? When you are going to die you should have the choice to go on a treatment which is untested. That's what people with AlS have been asking for YEARS and still cannot get because they have to follow the usual regulatory process.Cancer patients can get drugs as soon as Phase I, I don't see why we don't allow other patients who are in critical condition to try whatever is new out there. What do you have to lose?
- x0x0 12y ago
  The death rate from the current ebola is approximately 50%. While that sucks, what patients have to lose is both a 50% chance of living and their right not to be a playground for medical experimentation. edit: and just who vets the people/companies who get to offer drugs to desperately ill people? Does anybody with $1k to buy needles get to make a sign and advertise curative injections? I'm sure glibertarian idiots will say it was a freely made choice, but choices made while infected with ebola (or even scared of being so infected) aren't freely taken, not to mention the asymmetric information.
  - ekianjo 12y ago
    > edit: and just who vets the people/companies who get to offer drugs to desperately ill people? Look at the scientists who were helping fight Ebola in Africa. When they discovered they were infected as well they had the chance to take a new treatment and they took it. And they recovered. The question of who decides is important, I'm not saying it should be overlooked but the possibility is not even there for those who actually want to take it desperately. And no need to throw the "libertarian" word for everything you disagree with, we are talking about having choice here.
    - krschultz 12y ago
      And some of the people that were given the experimental drug in Africa died as well. Correlation does not equal causation. We all love silver bullets and magic serums, but the real answer here is to get the basics right. There are major improvements that can happen in sanitation, medical care, keeping quarantines effective, proper handling of the dead, etc. A lot of major epidemics were stopped in the 1800s and early 1900s with these kind of things, Ebola can be fought in many ways without inventing a drug. Solving the crisis on a large scale isn't really a "medical" challenge in the normal sense, it is about logistics and resources and public trust in government & doctors.
Padding 12y ago
I fully agree with you. This is the rational decision to make, and the best one, considering the fallibility of humans. At the same time though, we need to realize that this is primarily about protecting the health professionals and care givers, and only indirectly the sick. (The sick will of course indirectly profit from professionals being just that - professional, but only in the "long term".) We should have no delusions about willingly letting people die, in the name of professionalism, just to have a clean concience and the ability to claim to have done nothing wrong.
cstross 12y ago
There are pros and cons for both sides of this argument. The question is whether to suspend normal precautionary procedures during an extraordinary situation, not whether to ditch normal precautionary procedures which exist for very good reasons (see the Elixir Sulfanilamide disaster for why): http://www.fda.gov/aboutfda/whatwedo/history/productregulation/sulfanilamidedisaster/default.htm http://www.fda.gov/aboutfda/whatwedo/history/productregulati... You're rightly concerned for the possible side-effects of using untested treatments on people during an emergency. But flip the question around: who's liable for not deploying an available experimental treatment that is later determined to work, but only after tens of thousands have died while it sits, unused, on the shelf due to lack of test data?
- ObviousScience 12y ago
  > who's liable for not deploying an available experimental treatment that is later determined to work, but only after tens of thousands have died while it sits, unused, on the shelf due to lack of test data? No one, that's exactly the point. There's no way to sort out misdeeds, eg, fake cures from real attempts if we lift the normal trial and liability procedures. No one would use untrialed drugs if they had to take the full liability. So the reality is that there is no good way to send only useful drugs there while skipping the filtering process. If you're okay with some people being poisoned or lied to for money in the hope that some people will get a real drug, then we could make that work, but I'm not sure we want to go down that path.
  - cstross 12y ago
    There's no way to sort out misdeeds, eg, fake cures from real attempts if we lift the normal trial and liability procedures. No one would use untrialed drugs if they had to take the full liability. I'm ready to assume that medics treating an emergency epidemic are unlikely to knowingly turn to quack remedies -- homeopathic or bogus ones -- as opposed to items like ZMapp, a monoclonal antibody treatment by a well-regulated pharmaceutical company that just happens not to have been approved for human clinical trials yet. http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimenta... Furthermore, let me add that conducting a randomized controlled clinical trial (for effectiveness and safety) when dealing with a pathogenic infection with a > 50% fatality rate is arguably unethical: you can collect data on clinical applications and apply a retrospective control sample of patients to determine whether it improved the outcome where it was used, but withholding a potentially effective treatment becomes extremely problematic under some circumstances -- the historic classic example was zidovudine for HIV, which was rushed through human trials into use in just 27 months because it was the first effective treatment for a then-100% fatal disease (HIV). (Some of the double-blind trials were short-circuited when it became apparent that continuing to alternate patients with placebo controls was likely to be injurious.) http://en.wikipedia.org/wiki/Zidovudine http://en.wikipedia.org/wiki/Zidovudine
jcromartie 12y ago
This is not a proposal for developing general-purpose drugs. This is for developing emergency treatment for an acute viral outbreak emergency. If an anti-Ebola drug works, then it saves lives. If it doesn't work (or is dangerous) then it's still less dangerous than Ebola itself.

by waps 12y ago

ng12 12y ago

I would argue there are at least a few orders of magnitude between someone with morning sickness and someone who will almost definitely die of Ebola or T1 Diabetes. It's a calculated risk, sure, but I don't think the Thalidomide example is particularly relevant.

hueving 12y ago
>It's a calculated risk, sure, but I don't think the Thalidomide example is particularly relevant. It's very relevant. It shows that people are too willing to take risks with major unknowns. Where do you make the cutoff with your drug experiments? Only people that are certain to die? People with high exposure risk? People that are having difficulties recovering? Any selection you pick there is completely arbitrary because you don't know the potential downsides to the experimental stuff you want to try.
- ghshephard 12y ago
  "Where do you make the cutoff with your drug experiments? " I don't know where you make the cutoff, but I'm comfortable saying that its somewhere below having a disease with a 50% mortality rate in under 14 days. I'm pretty much okay taking any risk at that point.
  - Padding 12y ago
    You didn't get the point of the argument. What do you do when something with 51% mortality in 15 days comes up? And then something with 49% in 13 days .. where do you draw the line? And what do you do when people continue to cry out?
    - barrkel 12y ago
      The existence of a Sorites paradox doesn't mean that heaps and grains are not different things.
    - ghshephard 12y ago
      I got the point of the argument. And, I made it very clear that I don't know where to draw the line. All I know for sure, is that 50% mortality in 14 days comes below that line. Sign me up for an experimental treatment.
  - DanBC 12y ago
    What if the risk was survival but with locked-in syndrome and constant very high pain? Or survival but severely brain damaged - no ability to feed yourself; or talk; or understand the conversations of other people.
    - ctdonath 12y ago
      A risk? yes. But if that risk is significantly less than the other high-risk form of "severely brain damaged, unable to eat, talk, or understand" known as death, many would take it. Remember, the point is trying something that doctors & pharmacists believe has a sensible chance of actual _cure_ (perhaps with acceptable side effects better than death/dementia). I don't understand the propensity of some to demean "hey, there's a serious immediate problem, let's do everything we can to help" with "but it might (with minuscule odds) go horribly wrong! therefore we can't let anyone do anything that's not established best-condition status quo!" With that mindset, it's a wonder such people ever drive to work (you might die in a horrible flaming carbecue!). Statistical prioritization matters. Just because there isn't a perfect solution doesn't mean there isn't a better one.

narrator 12y ago

So you're suggesting that we let potentially hundreds of thousands of people die to prevent a potential tort lawsuit? Would you be ok if we shoot them if they try and leave the quarantine though to get an unapproved treatment? Do you see how crazy your logic is? The benefit of Thalidomide was that it prevented morning sickness and you're comparing that to treatment of a disease with a fatality rate of greater than 50%! You have no sense of proportion at all!

lotsofmangos 12y ago
It seems reasonably proportionate not to suspend all regulations on drug testing. If you did that then the vitamin peddlers out to make a fast buck would swamp anything that might actually help. The amount of con artists massively outnumbers the amount of people with a cure for Ebola. I agree that it may be an idea to look at trying some of the experimental treatments, however given there is a 50% chance of surviving with palliative care and that we know how to stop it spreading given the resources, I am not sure that turning the situation into an unregulated free-for-all for every quack looking to make their name will really help matters.

ekianjo 12y ago

Why? When you are going to die you should have the choice to go on a treatment which is untested. That's what people with AlS have been asking for YEARS and still cannot get because they have to follow the usual regulatory process.Cancer patients can get drugs as soon as Phase I, I don't see why we don't allow other patients who are in critical condition to try whatever is new out there. What do you have to lose?

x0x0 12y ago
The death rate from the current ebola is approximately 50%. While that sucks, what patients have to lose is both a 50% chance of living and their right not to be a playground for medical experimentation. edit: and just who vets the people/companies who get to offer drugs to desperately ill people? Does anybody with $1k to buy needles get to make a sign and advertise curative injections? I'm sure glibertarian idiots will say it was a freely made choice, but choices made while infected with ebola (or even scared of being so infected) aren't freely taken, not to mention the asymmetric information.
- ekianjo 12y ago
  > edit: and just who vets the people/companies who get to offer drugs to desperately ill people? Look at the scientists who were helping fight Ebola in Africa. When they discovered they were infected as well they had the chance to take a new treatment and they took it. And they recovered. The question of who decides is important, I'm not saying it should be overlooked but the possibility is not even there for those who actually want to take it desperately. And no need to throw the "libertarian" word for everything you disagree with, we are talking about having choice here.
  - krschultz 12y ago
    And some of the people that were given the experimental drug in Africa died as well. Correlation does not equal causation. We all love silver bullets and magic serums, but the real answer here is to get the basics right. There are major improvements that can happen in sanitation, medical care, keeping quarantines effective, proper handling of the dead, etc. A lot of major epidemics were stopped in the 1800s and early 1900s with these kind of things, Ebola can be fought in many ways without inventing a drug. Solving the crisis on a large scale isn't really a "medical" challenge in the normal sense, it is about logistics and resources and public trust in government & doctors.

Padding 12y ago

I fully agree with you. This is the rational decision to make, and the best one, considering the fallibility of humans. At the same time though, we need to realize that this is primarily about protecting the health professionals and care givers, and only indirectly the sick. (The sick will of course indirectly profit from professionals being just that - professional, but only in the "long term".) We should have no delusions about willingly letting people die, in the name of professionalism, just to have a clean concience and the ability to claim to have done nothing wrong.

cstross 12y ago

There are pros and cons for both sides of this argument. The question is whether to suspend normal precautionary procedures during an extraordinary situation, not whether to ditch normal precautionary procedures which exist for very good reasons (see the Elixir Sulfanilamide disaster for why): http://www.fda.gov/aboutfda/whatwedo/history/productregulation/sulfanilamidedisaster/default.htm http://www.fda.gov/aboutfda/whatwedo/history/productregulati... You're rightly concerned for the possible side-effects of using untested treatments on people during an emergency. But flip the question around: who's liable for not deploying an available experimental treatment that is later determined to work, but only after tens of thousands have died while it sits, unused, on the shelf due to lack of test data?

ObviousScience 12y ago
> who's liable for not deploying an available experimental treatment that is later determined to work, but only after tens of thousands have died while it sits, unused, on the shelf due to lack of test data? No one, that's exactly the point. There's no way to sort out misdeeds, eg, fake cures from real attempts if we lift the normal trial and liability procedures. No one would use untrialed drugs if they had to take the full liability. So the reality is that there is no good way to send only useful drugs there while skipping the filtering process. If you're okay with some people being poisoned or lied to for money in the hope that some people will get a real drug, then we could make that work, but I'm not sure we want to go down that path.
- cstross 12y ago
  There's no way to sort out misdeeds, eg, fake cures from real attempts if we lift the normal trial and liability procedures. No one would use untrialed drugs if they had to take the full liability. I'm ready to assume that medics treating an emergency epidemic are unlikely to knowingly turn to quack remedies -- homeopathic or bogus ones -- as opposed to items like ZMapp, a monoclonal antibody treatment by a well-regulated pharmaceutical company that just happens not to have been approved for human clinical trials yet. http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimenta... Furthermore, let me add that conducting a randomized controlled clinical trial (for effectiveness and safety) when dealing with a pathogenic infection with a > 50% fatality rate is arguably unethical: you can collect data on clinical applications and apply a retrospective control sample of patients to determine whether it improved the outcome where it was used, but withholding a potentially effective treatment becomes extremely problematic under some circumstances -- the historic classic example was zidovudine for HIV, which was rushed through human trials into use in just 27 months because it was the first effective treatment for a then-100% fatal disease (HIV). (Some of the double-blind trials were short-circuited when it became apparent that continuing to alternate patients with placebo controls was likely to be injurious.) http://en.wikipedia.org/wiki/Zidovudine http://en.wikipedia.org/wiki/Zidovudine

jcromartie 12y ago

This is not a proposal for developing general-purpose drugs. This is for developing emergency treatment for an acute viral outbreak emergency. If an anti-Ebola drug works, then it saves lives. If it doesn't work (or is dangerous) then it's still less dangerous than Ebola itself.