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I'm really surprised that this is news, or that it's being upvoted on HN. Apparently deaths during trials are really rare. From the article: >A meta-analysis o

I'm really surprised that this is news, or that it's being upvoted on HN. Apparently deaths during trials are really rare. From the article: >A meta-analysis of non-cancer Phase 1 drug trials, published last year in The British Medical Journal, found serious adverse events in only 0.31 percent of participants, and no life-threatening events or deaths. And the last event comparable to this, according to the article, happened in 2006 in a different country. I was surprised by this. I would not have expected drug trials to be risk free, in fact I thought that was the whole point. Apparently they are already super conservative and safe. I'm not sure why people are alarmed or calling for more regulation. It's probably impossible to 100% safety, and certainly not desirable. Parent comment is definitely right that we kill more people through inaction and need to be far more liberal. Total lives saved is all that should matter. Somehow one person dying out of many drug trials over many years is news that's on the front page of HN. But the 22,000 people that died of cancer today isn't.

Fomite 11y ago
Part of the issue is, medically, we (where we = the medical community) killed those people, whereas cancer killed the other 22,000. Medical ethics are expressly meant to protect subjects from experimentation purely on the basis of "This will probably help more people than it hurts." Given the events that prompted the development of those guidelines, I'm not sure they're wrong.
- selestify 11y ago
  > experimentation purely on the basis of "This will probably help more people than it hurts." And why is this bad?
  - Fomite 11y ago
    Because it very, very easily goes some very dark places, especially when you start talking about extreme risk to one person versus a diffuse benefit over several million.
    - selestify 11y ago
      > extreme risk to one person versus a diffuse benefit over several million Interesting, do you have any actual examples of this?
  - anigbrowl 11y ago
    Because people are actually kind of shitty at estimating probabilities, and overconfidence in this area is likely to kill or injure a lot of people. I'm a utilitarian by temperament, but a deontologist in practice because I'm aware that my powers of foresight are actually quite limited and I will very rarely be presented with neatly predictable conflicting imperatives as in the trolley problem. Many self-professed utilitarians wildly overestimate their own intellectual and analytical abilities and come to grief on the rocks of failed predictions. Unfortunately this also tends to involve a lot of innocent casualties too.
    - Houshalter 11y ago
      On a case by case basis you might have a point, but over time we have tons of statistics on how many drug trials fail and hurt people, vs succeed and save people. It would be relatively easy to calculate the risk/benefit objectively. That's also an ideal use case for prediction markets, if you want to get really good predictions. Also, I've heard this argument used before in other contexts. Do people really believe that because you can't make perfect predictions, you should default to inaction? That's just silly. You do the best with what you know and believe. And if you really believe your predictions are wrong, then you can just adjust them accordingly and make them correct. If you don't believe that, then you obviously wouldn't find that argument convincing in the first place.
      - Fomite 11y ago
        We don't default to inaction. We default to careful action. There's a vast difference.
- Houshalter 11y ago
  I'm not sure how this is even controversial. We should try to save the most people possible. It doesn't matter who is responsible for a death, it's just as sad whether it's cancer or a failed drug. Any rational person would take a one in a billion risk of dying in a medical trial if it gave them access to all sorts of cures and treatments for terrible diseases. And that's if we were selecting participants at random from the entire first world population, when it's actually done by consenting volunteers who get paid for the risk they take.
  - Fomite 11y ago
    It does matter who is responsible for a death. In the same way we don't pick people off the street and harvest their organs, so long as there are 2+ people on the donor pool who could use them. To follow that: 1. People aren't rational. 2. You're not talking about "Roll this dice and we'll cure all manner of things." You're talking about "Roll this dice and we maybe, if everything goes well and it shows efficacy, might see a treatment for a disease on the market in a few decades". 3. It's not 1 in a billion. It's 1 in X, where X is unknown. Asking a volunteer to take that risk is both easier and more ethical if you've done your best to minimize X.
    - Houshalter 11y ago
      >In the same way we don't pick people off the street and harvest their organs, so long as there are 2+ people on the donor pool who could use them. Well ideally we should do that. If it really saved more people. It could be done entirely voluntarily, through a lottery. And it would be rational for everyone to sign up, since you are more likely to need an organ at some point in your life, then to lose the lottery. The rest of your comment is just a misunderstanding of statistics. Out of decades of hundreds of phase 1 trials, very very few people have died. The risk is known. We also have invented many new drugs that have had many benefits and saved many lives, which can also be measured.
      - Fomite 11y ago
        I have a PhD in Epidemiology. Studying risk is what I do for a living. And no, the risk is not known. It's known to be "pretty damned low" for the aggregation of all Phase I trials, but for any given patient, and any given drug, we don't know the risk. Approaching clinical trials in human subjects with caution and care is what has made that risk as low as it is.
k-mcgrady 11y ago
>> "I'm really surprised that this is news[...] Apparently deaths during trials are really rare." That's why it's news. If it was a regular accepted occurrence it wouldn't be news. At the start of the Syrian civil war deaths and battles were front page news, now they happen daily and we don't hear about it.
- singlow 11y ago
  I don't think he is drawing the connection you see there. I read it like you the first time. I think he meant that he is surprised it is newsworthy and is also surprised at how rare they are. He was assuming these were more common, but not being reported on.
  - k-mcgrady 11y ago
    Ah, that makes sense.
DanBC 11y ago
Did we learn from any mistakes made during that last event? http://www.alltrials.net/news/comment-from-ben-goldacre-on-the-phase-1-clinical-trial-disaster-in-france/ http://www.alltrials.net/news/comment-from-ben-goldacre-on-t...
danieltillett 11y ago
I remember reading a paper on this topic many years ago (sorry I can't find it now), but the participants were at higher risk getting to the trial site than anything that happened during the trial.

Fomite 11y ago

Part of the issue is, medically, we (where we = the medical community) killed those people, whereas cancer killed the other 22,000. Medical ethics are expressly meant to protect subjects from experimentation purely on the basis of "This will probably help more people than it hurts." Given the events that prompted the development of those guidelines, I'm not sure they're wrong.

selestify 11y ago
> experimentation purely on the basis of "This will probably help more people than it hurts." And why is this bad?
- Fomite 11y ago
  Because it very, very easily goes some very dark places, especially when you start talking about extreme risk to one person versus a diffuse benefit over several million.
  - selestify 11y ago
    > extreme risk to one person versus a diffuse benefit over several million Interesting, do you have any actual examples of this?
- anigbrowl 11y ago
  Because people are actually kind of shitty at estimating probabilities, and overconfidence in this area is likely to kill or injure a lot of people. I'm a utilitarian by temperament, but a deontologist in practice because I'm aware that my powers of foresight are actually quite limited and I will very rarely be presented with neatly predictable conflicting imperatives as in the trolley problem. Many self-professed utilitarians wildly overestimate their own intellectual and analytical abilities and come to grief on the rocks of failed predictions. Unfortunately this also tends to involve a lot of innocent casualties too.
  - Houshalter 11y ago
    On a case by case basis you might have a point, but over time we have tons of statistics on how many drug trials fail and hurt people, vs succeed and save people. It would be relatively easy to calculate the risk/benefit objectively. That's also an ideal use case for prediction markets, if you want to get really good predictions. Also, I've heard this argument used before in other contexts. Do people really believe that because you can't make perfect predictions, you should default to inaction? That's just silly. You do the best with what you know and believe. And if you really believe your predictions are wrong, then you can just adjust them accordingly and make them correct. If you don't believe that, then you obviously wouldn't find that argument convincing in the first place.
    - Fomite 11y ago
      We don't default to inaction. We default to careful action. There's a vast difference.
Houshalter 11y ago
I'm not sure how this is even controversial. We should try to save the most people possible. It doesn't matter who is responsible for a death, it's just as sad whether it's cancer or a failed drug. Any rational person would take a one in a billion risk of dying in a medical trial if it gave them access to all sorts of cures and treatments for terrible diseases. And that's if we were selecting participants at random from the entire first world population, when it's actually done by consenting volunteers who get paid for the risk they take.
- Fomite 11y ago
  It does matter who is responsible for a death. In the same way we don't pick people off the street and harvest their organs, so long as there are 2+ people on the donor pool who could use them. To follow that: 1. People aren't rational. 2. You're not talking about "Roll this dice and we'll cure all manner of things." You're talking about "Roll this dice and we maybe, if everything goes well and it shows efficacy, might see a treatment for a disease on the market in a few decades". 3. It's not 1 in a billion. It's 1 in X, where X is unknown. Asking a volunteer to take that risk is both easier and more ethical if you've done your best to minimize X.
  - Houshalter 11y ago
    >In the same way we don't pick people off the street and harvest their organs, so long as there are 2+ people on the donor pool who could use them. Well ideally we should do that. If it really saved more people. It could be done entirely voluntarily, through a lottery. And it would be rational for everyone to sign up, since you are more likely to need an organ at some point in your life, then to lose the lottery. The rest of your comment is just a misunderstanding of statistics. Out of decades of hundreds of phase 1 trials, very very few people have died. The risk is known. We also have invented many new drugs that have had many benefits and saved many lives, which can also be measured.
    - Fomite 11y ago
      I have a PhD in Epidemiology. Studying risk is what I do for a living. And no, the risk is not known. It's known to be "pretty damned low" for the aggregation of all Phase I trials, but for any given patient, and any given drug, we don't know the risk. Approaching clinical trials in human subjects with caution and care is what has made that risk as low as it is.

k-mcgrady 11y ago

>> "I'm really surprised that this is news[...] Apparently deaths during trials are really rare." That's why it's news. If it was a regular accepted occurrence it wouldn't be news. At the start of the Syrian civil war deaths and battles were front page news, now they happen daily and we don't hear about it.

singlow 11y ago
I don't think he is drawing the connection you see there. I read it like you the first time. I think he meant that he is surprised it is newsworthy and is also surprised at how rare they are. He was assuming these were more common, but not being reported on.
- k-mcgrady 11y ago
  Ah, that makes sense.

DanBC 11y ago

Did we learn from any mistakes made during that last event? http://www.alltrials.net/news/comment-from-ben-goldacre-on-the-phase-1-clinical-trial-disaster-in-france/ http://www.alltrials.net/news/comment-from-ben-goldacre-on-t...

danieltillett 11y ago

I remember reading a paper on this topic many years ago (sorry I can't find it now), but the participants were at higher risk getting to the trial site than anything that happened during the trial.