12 ms·

I signed up for human challenge trials last spring so had lots of debates on this - it usually ended with the person saying directly or indirectly "Bioethicists

I signed up for human challenge trials last spring so had lots of debates on this - it usually ended with the person saying directly or indirectly "Bioethicists have discussed this for decades and understand it more than you". I found this extremely unconvincing. A group of unelected people, mostly from the same social class, being able to determine the rules of something so important seemed inherently flawed to me. In this particular situation, I saw it as signing up to be a soldier for my country (which always covers some personal risk) - with the number of lives that could have been saved by April 2020 human challenge trial being in the tens or hundreds of thousands of dollars.

minikites 6y ago
>A group of unelected people How would it be better if they were elected?
- TheAdamAndChe 6y ago
  There's at least a possibility of accountability with elected officials. If they work against the peoples' interests too much, they get voted out.
  - gruez 6y ago
    >If they work against the peoples' interests too much, they get voted out. only if the people aren't blinded by partisanship and realize it.
  - minikites 6y ago
    How's that been working out lately?
dcolkitt 6y ago
Just because a group focuses on a topic does not mean that they possess any genuine expertise. Nobody rational would claim that we should listen to astrologers about fortune telling. A more prosaic example is that virtually zero mutual fund managers outperform the market. Pundits are not any better at forecasting political events than the average person. Experience alone is not enough. You must demonstrate evidence of actual expertise. Ethicists behave no more ethically than the average person[1], which strongly suggests that the entire field is worthless. A rational person should ignore the established field of bioethics. Maybe even take the opposite of their advice. [1]https://qz.com/1582149/ethicists-are-no-more-ethical-than-the-rest-of-us-study-finds/ https://qz.com/1582149/ethicists-are-no-more-ethical-than-th...
- StavrosK 6y ago
  > Ethicists behave no more ethically than the average person[1], which strongly suggests that the entire field is worthless. I don't see how that follows. We don't expect our ethicists to behave more ethically any more than we expect our aeronautics engineers to fly.
  - graeme 6y ago
    But aeronautics engineers can’t fly. However all humans possess the capacity to behave ethically. We do generally expect a teacher to be able to explain a concept outside of their job, a writer to write a good note or letter, a photographer to take a good photograph when out casually with friends and family. Similarly we’d want people making moral judgement to demonstrate that capacity.
    - StavrosK 6y ago
      Ethicists study ethics. Per your example, I would expect an ethicist to be able to study ethics very well. You don't expect a teacher to know everything, or a writer to always speak with perfect eloquence, or a photographer to always take great photos. I don't understand why someone who studies ethics should behave better, any more than someone who studies the human musculature to be able to lift more weight.
      - throwaway3699 6y ago
        You expect some correlation. Even 5%.
    - celticninja 6y ago
      But surely all you could expect is that they consider the ethics of the situation. Not that they always choose the the most ethically correct outcome. After all a writer might just need a shopping list, not a sonnet.
- hntrader 6y ago
  One nitpick. A huge number of mutual funds outperform the market. Something like 40 percent of them, which would be in the hundreds to thousands. It's the average over all of them (after accounting for survivorship bias) that underperforms. I otherwise wholeheartedly agree with everything you've written. Self-proclaimed expertise should be viewed with a very healthy scepticism, and the burden of proof isn't on you to show why they're wrong, it's on them to show why they're right without resorting to an argument from authority.
tyho 6y ago
I agree. The Moderna vaccine was created in a weekend, it took many months to run trials in a way that compiled with bioethicist diktat to prove efficacy . The limiting factor in the speed of the clinical trials is the rate at which people acquire COVID naturally. During the summer there were serious worries that the vaccine trials would fail due to low transmission rates. Had the clinical trials run in a "less ethical" way, say by taking young and healthy people like myself, vaccinating them and then deliberately exposing them to COVID, then we might have seen vaccination start much sooner. Far fewer would have died and the colossal impact of lockdowns would have been mostly avoided.
- oldgradstudent 6y ago
  > Had the clinical trials run in a "less ethical" way, say by taking young and healthy people like myself And what exactly would that have told you about the safety and effectiveness of the vaccine for the people at risk, those who are neither young nor healthy? And how many people would you need to challenge to show that the vaccine prevents deaths or even serious disease? The young and healthy rarely get the full brunt of the disease.
  - ericb 6y ago
    You can still measure: the immune response, antibodies, white blood cells, scenarios in which the contagion can spread, minimal social distance needed, length of exposure required for transmission, how much masks stop transmission, safety (risk reduction), and peak efficacy. You can do it on a much shorter timescale, and with fewer lives lost. What if we had needed to iterate to fix problems in the vaccine? How many would die waiting? To your specific question, you still derisk it for the elderly. If it causes problems in young adults, you quit because it would probably cause even more problems in riskier groups. If it doesn't, you move forward into older groups. Let's not pretend you would learn nothing that would speed things along. Some of these questions aren't answered quantitatively even now.
    - oldgradstudent 6y ago
      > You can still measure: the immune response, antibodies, white blood cells, scenarios in which the contagion can spread, minimal social distance needed, length of exposure required for transmission, how much masks stop transmission, safety (risk reduction), and peak efficacy. [...] Of course. These are all great uses for challenge studies, I was responding specifically to testing the vaccine using a challenge study on healthy young adults. > If it causes problems in young adults, you quit because it would probably cause even more problems in riskier groups. If it doesn't, you move forward into older groups. It turns out that both Pfizer and Moderna trials have shown much more adverse reactions in the young than the old. Testing on the wrong population may result in rejecting a vaccine that could be perfectly safe on the at-risk population, but inappropriate for the general population. > Let's not pretend you would learn nothing that would speed things along Of course not. You could learn a lot, just not about the safety and efficacy profile of the vaccine on the at-risk population.
worker767424 6y ago
> "Bioethicists have discussed this for decades and understand it more than you". To the bioethicists, ok, boomer.
akiselev 6y ago
Human medical experimentation has a horrifying history and in living memory alone we have the atrocities during WWII, MK ultra, Tuskegee experiment, past (and ongoing) experiments on aboriginal populations, Operation Whitecoat, the Ohio prison experiments, and the entire pharma industry pre-Kefauver-Harris Drug Amendment but the Beecher paper really drove home how widespread the practice was in regular medical research. Unethical experimentation wasn't the stuff of war crimes, it was a relatively common practice for everyday medical researchers even a few decades ago with dire consequences for medicine. It's no more elitist than an electrician telling someone that they can't wire their house themselves "because construction and safety organizations have studied this for decades and understand it more than you" when burning down the entire block is a very real possibility. The consequences of breaches in medical ethics have been dire: to this day minority and aboriginal populations have worse health outcomes because they have lower trust in the medical establishment and even relatively small breaches in trust like the CIA vaccination program in Pakistan can have devastating effects like the revival of polio. Bioethics and "modern" medicine are relative new so we're well into the conservative whiplash stage of the natural "boom and bust cycle" but for a damn good reason. You're not going to appreciate the seriousness of the subject without really digging into the very recent history of bioethics.
- trulyme 6y ago
  There is a big difference between signing up willingly to be a test subject for a specific disease, where you are more or less aware of the risks and accept them of free will, versus being experimented on without choice in the matter. GP was talking about former, you are judging the latter.
  - omginternets 6y ago
    And there are real questions about the enlightened part of "enlightened consent".
    - michaelt 6y ago
      If that's the case, how can anyone consent to anything? Can I consent to getting a taxi ride to the doctor's office, when we might get in a car crash and die?
ketamine__ 6y ago
What happened with the trial?
X3Xs4gF9oB 6y ago
A number of bioethicists support human challenge trials [1-3]. The blame shouldn't lie with them. Politicians and government regulators have failed us by not actively pushing for challenge trials. Kudos to Members of Congress Bill Foster and Donna Shalala for trying [4]. [1] https://academic.oup.com/jid/article/221/11/1752/5814216 https://academic.oup.com/jid/article/221/11/1752/5814216 [2] https://pubmed.ncbi.nlm.nih.gov/33334616/ https://pubmed.ncbi.nlm.nih.gov/33334616/ [3] https://pubmed.ncbi.nlm.nih.gov/32441894/ https://pubmed.ncbi.nlm.nih.gov/32441894/ [4] https://foster.house.gov/hhs-fda https://foster.house.gov/hhs-fda
pcrh 6y ago
>A group of unelected people, mostly from the same social class, being able to determine the rules of something so important seemed inherently flawed to me. None of these points pertain to the scientific, medical or ethical rationales behind doing human challenge trials.
Balgair 6y ago
In the US at least, Institutional Review Boards (IRBs) are mandated by law[0] to have 'varying backgrounds'. The Part is pretty specific in terms of what it's asking for. To me it sounds very reasonable, if in legalese. I am not aware of what particular regulations the challenge trial was under, though. So IRB regulations may be mute in this case "46.107 IRB membership (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (e) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB." [0] https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.107 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...

minikites 6y ago

>A group of unelected people How would it be better if they were elected?

TheAdamAndChe 6y ago
There's at least a possibility of accountability with elected officials. If they work against the peoples' interests too much, they get voted out.
- gruez 6y ago
  >If they work against the peoples' interests too much, they get voted out. only if the people aren't blinded by partisanship and realize it.
- minikites 6y ago
  How's that been working out lately?

dcolkitt 6y ago

Just because a group focuses on a topic does not mean that they possess any genuine expertise. Nobody rational would claim that we should listen to astrologers about fortune telling. A more prosaic example is that virtually zero mutual fund managers outperform the market. Pundits are not any better at forecasting political events than the average person. Experience alone is not enough. You must demonstrate evidence of actual expertise. Ethicists behave no more ethically than the average person[1], which strongly suggests that the entire field is worthless. A rational person should ignore the established field of bioethics. Maybe even take the opposite of their advice. [1]https://qz.com/1582149/ethicists-are-no-more-ethical-than-the-rest-of-us-study-finds/ https://qz.com/1582149/ethicists-are-no-more-ethical-than-th...

StavrosK 6y ago
> Ethicists behave no more ethically than the average person[1], which strongly suggests that the entire field is worthless. I don't see how that follows. We don't expect our ethicists to behave more ethically any more than we expect our aeronautics engineers to fly.
- graeme 6y ago
  But aeronautics engineers can’t fly. However all humans possess the capacity to behave ethically. We do generally expect a teacher to be able to explain a concept outside of their job, a writer to write a good note or letter, a photographer to take a good photograph when out casually with friends and family. Similarly we’d want people making moral judgement to demonstrate that capacity.
  - StavrosK 6y ago
    Ethicists study ethics. Per your example, I would expect an ethicist to be able to study ethics very well. You don't expect a teacher to know everything, or a writer to always speak with perfect eloquence, or a photographer to always take great photos. I don't understand why someone who studies ethics should behave better, any more than someone who studies the human musculature to be able to lift more weight.
    - throwaway3699 6y ago
      You expect some correlation. Even 5%.
  - celticninja 6y ago
    But surely all you could expect is that they consider the ethics of the situation. Not that they always choose the the most ethically correct outcome. After all a writer might just need a shopping list, not a sonnet.
hntrader 6y ago
One nitpick. A huge number of mutual funds outperform the market. Something like 40 percent of them, which would be in the hundreds to thousands. It's the average over all of them (after accounting for survivorship bias) that underperforms. I otherwise wholeheartedly agree with everything you've written. Self-proclaimed expertise should be viewed with a very healthy scepticism, and the burden of proof isn't on you to show why they're wrong, it's on them to show why they're right without resorting to an argument from authority.

tyho 6y ago

I agree. The Moderna vaccine was created in a weekend, it took many months to run trials in a way that compiled with bioethicist diktat to prove efficacy . The limiting factor in the speed of the clinical trials is the rate at which people acquire COVID naturally. During the summer there were serious worries that the vaccine trials would fail due to low transmission rates. Had the clinical trials run in a "less ethical" way, say by taking young and healthy people like myself, vaccinating them and then deliberately exposing them to COVID, then we might have seen vaccination start much sooner. Far fewer would have died and the colossal impact of lockdowns would have been mostly avoided.

oldgradstudent 6y ago
> Had the clinical trials run in a "less ethical" way, say by taking young and healthy people like myself And what exactly would that have told you about the safety and effectiveness of the vaccine for the people at risk, those who are neither young nor healthy? And how many people would you need to challenge to show that the vaccine prevents deaths or even serious disease? The young and healthy rarely get the full brunt of the disease.
- ericb 6y ago
  You can still measure: the immune response, antibodies, white blood cells, scenarios in which the contagion can spread, minimal social distance needed, length of exposure required for transmission, how much masks stop transmission, safety (risk reduction), and peak efficacy. You can do it on a much shorter timescale, and with fewer lives lost. What if we had needed to iterate to fix problems in the vaccine? How many would die waiting? To your specific question, you still derisk it for the elderly. If it causes problems in young adults, you quit because it would probably cause even more problems in riskier groups. If it doesn't, you move forward into older groups. Let's not pretend you would learn nothing that would speed things along. Some of these questions aren't answered quantitatively even now.
  - oldgradstudent 6y ago
    > You can still measure: the immune response, antibodies, white blood cells, scenarios in which the contagion can spread, minimal social distance needed, length of exposure required for transmission, how much masks stop transmission, safety (risk reduction), and peak efficacy. [...] Of course. These are all great uses for challenge studies, I was responding specifically to testing the vaccine using a challenge study on healthy young adults. > If it causes problems in young adults, you quit because it would probably cause even more problems in riskier groups. If it doesn't, you move forward into older groups. It turns out that both Pfizer and Moderna trials have shown much more adverse reactions in the young than the old. Testing on the wrong population may result in rejecting a vaccine that could be perfectly safe on the at-risk population, but inappropriate for the general population. > Let's not pretend you would learn nothing that would speed things along Of course not. You could learn a lot, just not about the safety and efficacy profile of the vaccine on the at-risk population.

worker767424 6y ago

> "Bioethicists have discussed this for decades and understand it more than you". To the bioethicists, ok, boomer.

akiselev 6y ago

Human medical experimentation has a horrifying history and in living memory alone we have the atrocities during WWII, MK ultra, Tuskegee experiment, past (and ongoing) experiments on aboriginal populations, Operation Whitecoat, the Ohio prison experiments, and the entire pharma industry pre-Kefauver-Harris Drug Amendment but the Beecher paper really drove home how widespread the practice was in regular medical research. Unethical experimentation wasn't the stuff of war crimes, it was a relatively common practice for everyday medical researchers even a few decades ago with dire consequences for medicine. It's no more elitist than an electrician telling someone that they can't wire their house themselves "because construction and safety organizations have studied this for decades and understand it more than you" when burning down the entire block is a very real possibility. The consequences of breaches in medical ethics have been dire: to this day minority and aboriginal populations have worse health outcomes because they have lower trust in the medical establishment and even relatively small breaches in trust like the CIA vaccination program in Pakistan can have devastating effects like the revival of polio. Bioethics and "modern" medicine are relative new so we're well into the conservative whiplash stage of the natural "boom and bust cycle" but for a damn good reason. You're not going to appreciate the seriousness of the subject without really digging into the very recent history of bioethics.

trulyme 6y ago
There is a big difference between signing up willingly to be a test subject for a specific disease, where you are more or less aware of the risks and accept them of free will, versus being experimented on without choice in the matter. GP was talking about former, you are judging the latter.
- omginternets 6y ago
  And there are real questions about the enlightened part of "enlightened consent".
  - michaelt 6y ago
    If that's the case, how can anyone consent to anything? Can I consent to getting a taxi ride to the doctor's office, when we might get in a car crash and die?

ketamine__ 6y ago

What happened with the trial?

X3Xs4gF9oB 6y ago

A number of bioethicists support human challenge trials [1-3]. The blame shouldn't lie with them. Politicians and government regulators have failed us by not actively pushing for challenge trials. Kudos to Members of Congress Bill Foster and Donna Shalala for trying [4]. [1] https://academic.oup.com/jid/article/221/11/1752/5814216 https://academic.oup.com/jid/article/221/11/1752/5814216 [2] https://pubmed.ncbi.nlm.nih.gov/33334616/ https://pubmed.ncbi.nlm.nih.gov/33334616/ [3] https://pubmed.ncbi.nlm.nih.gov/32441894/ https://pubmed.ncbi.nlm.nih.gov/32441894/ [4] https://foster.house.gov/hhs-fda https://foster.house.gov/hhs-fda

pcrh 6y ago

>A group of unelected people, mostly from the same social class, being able to determine the rules of something so important seemed inherently flawed to me. None of these points pertain to the scientific, medical or ethical rationales behind doing human challenge trials.

Balgair 6y ago

In the US at least, Institutional Review Boards (IRBs) are mandated by law[0] to have 'varying backgrounds'. The Part is pretty specific in terms of what it's asking for. To me it sounds very reasonable, if in legalese. I am not aware of what particular regulations the challenge trial was under, though. So IRB regulations may be mute in this case "46.107 IRB membership (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. (b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession. (c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (e) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB." [0] https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.107 https://www.hhs.gov/ohrp/regulations-and-policy/regulations/...