[HN Gopher] Coronavirus human challenge study gets green light i...
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Coronavirus human challenge study gets green light in UK
Author : timthorn
Score : 77 points
Date : 2021-02-17 14:24 UTC (6 hours ago)
(HTM) web link (www.politico.eu)
(TXT) w3m dump (www.politico.eu)
| Exmoor wrote:
| This could become increasingly important more of the population
| becomes vaccinated and case rates continue to fall. If a variant
| that is able to evade vaccinated immunity occurs we have the
| technology to quickly develop updated mRNA vaccines to combat it,
| but with reduced infection rates it could take many months and
| high number of participants before the efficacy of an updated
| vaccine or booster is apparent.
| handmodel wrote:
| 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 wrote:
| >A group of unelected people
|
| How would it be better if they were elected?
| TheAdamAndChe wrote:
| 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 wrote:
| >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 wrote:
| How's that been working out lately?
| dcolkitt wrote:
| 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-
| th...
| StavrosK wrote:
| > 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.
| tyho wrote:
| 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.
| TamDenholm wrote:
| Not disagreeing with you at all, but this has a parallel with
| the age old hypothetical questions that people regularly ask
| each other. Would you kill 1 person to save 100 people? I
| don't think theres even a correct answer, its all opinion.
|
| Having no knowledge of the field of ethicists, i would
| imagine that these are the kinds of things they debate all
| day long, theres a million variations on the same question.
| defen wrote:
| In this case it's more like "would you allow a group of
| 18-20 year olds to voluntarily deliberately expose
| themselves to the same risk of death presented by driving
| 7,500 miles in order to save the lives of a million
| people?"
| Jabbles wrote:
| Surely the general question doesn't matter though, and all
| the millions of variations are irrelevant, as there is a
| specific example that you want to consider.
| oldgradstudent wrote:
| > 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.
| mjmahone17 wrote:
| > 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?
|
| So if the goal was to reduce transmission, you can save a
| lot of lives of those at risk by vaccinating the young and
| healthy. It would be reasonable to basically use challenge
| studies to get a lower transmission rate, while in parallel
| using standard trials to prove the efficacy in at risk
| populations.
|
| Getting more data quicker is usually a good way to make
| more informed decisions, even if the data isn't exactly
| what you want it to be to make the perfectly optimal
| choices.
| runako wrote:
| > So if the goal was to reduce transmission, you can save
| a lot of lives of those at risk by vaccinating the young
| and healthy.
|
| Has this been tested yet? Is there evidence that this is
| true beyond the broad population surveys like those from
| Israel? (The accuracy of those data were hotly debated
| here last week.)
|
| Surely a study to determine actual transmission rates
| would be much more complex than one to determine whether
| young & healthy people are infected after inoculation
| (which again: not that useful of a data point by itself)?
| Closi wrote:
| Well transmission effectiveness is a good example of
| something that's much easier to measure in a controlled
| challenge study and almost impossible to measure pre-
| rollout without it!
| runako wrote:
| How? The vaccinated individuals would come into contact
| with lots of people who are not vaccinated. How do you
| track all of them to determine if vaccinated individuals
| can transmit the disease? That seems like a much larger
| logistical problem that differs from the existing (and
| challenge) trials in very material ways.
| Closi wrote:
| Well you observe transmission within a controlled
| environment - ie you keep people in the lab and don't let
| them go home.
|
| You take 50 people, vaccinate half and give half a
| placebo, infect them with Covid, then put them in 50
| rooms with 50 other unvaccinated people (so each has two
| people) for 2 weeks and see what happens.
|
| The reason you can't do it without a challenge trial is
| exactly because of what you said - you can't track
| infections in the community.
| ericb wrote:
| 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?
|
| 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.
| tyho wrote:
| I have signed up. Any legal reason to leave the house will do. I
| am loosing my sanity.
| opwieurposiu wrote:
| Don't tell the trial about your lack of sanity, insane people
| can not give informed consent. Seriously though, thanks for
| taking a risk to help out the human race.
| aphextron wrote:
| >I am loosing my sanity.
|
| Have you ever lost your ability to breathe? I can assure you
| it's much worse.
| philwelch wrote:
| Better late than never, I guess.
| runako wrote:
| Some people in this thread are saying we should have allowed
| challenge trials in February 2020, soon after the initial vaccine
| candidates were developed. But reading TFA:
|
| "The drug Remdesivir will be used as soon as volunteers start
| developing symptoms."
|
| Remdesivir broadly wasn't available in February 2020 as an
| approved drug. It still isn't in the EU, and broad US
| availability didn't come until the fall. It cannot be overstated
| how new are many of the drugs involved in the Covid response.
| It's not just the vaccine platforms, of which at least 2(!) are
| seeing their first use.
|
| Accepted therapeutic options have AFAIK always been a part of
| challenge trial protocols. The difference is that in e.g. March
| 2020, the doses given to healthy challenge trial participants
| would have been quite literally taken from a hospitalized patient
| on a respirator. That's obviously unethical.
|
| (The other option is to ask physicians to violate their
| Hippocratic oaths during the trial, which is a slippery slope.)
| fallingknife wrote:
| Strange that, until this point, the virus has been deemed
| dangerous enough to shut down whole swathes of the economy for a
| year, but not dangerous enough to bend the rules of clinical
| trials to find a vaccine faster. If we had done this sooner, we
| might have got the vaccine out before the mutant strains appeared
| over the last couple months.
| fabian2k wrote:
| I don't know enough about this trial to decide yet whether it
| is ethical or not. But there are in any case some differences
| to a full trial for a vaccine. This is a trial with young
| people, for a real vaccine trial you also need to know if it
| works in older people and the mortality is so much higher then
| that it would be clearly unethical to perform this trial.
| fallingknife wrote:
| How can it be unethical if everyone is a volunteer?
|
| Also, has there ever been a case of a vaccine that only works
| on one age group?
| Closi wrote:
| I personally find this study totally ethical, but I guess
| the counter-argument would be "How risky is an experiment
| allowed to be before it's considered unethical, even if
| people are volunteering?".
|
| Like let's say we wanted to verify if some liquid was a
| poison, and we thought it had a 50/50 chance of killing
| someone, and we offer someone PS500k to drink it, is that
| ethical? Probably not. I mean ethics are always subjective,
| but I don't think that's right. Does it make it ethical if
| it will probably save two lives? Uhh, I'm still
| uncomfortable with it...
|
| So after that point you are just arguing about how risky
| the experiment is allowed to be before it becomes
| unethical, and what benefit it will have for other people
| in relation to that risk.
|
| Again, I agree with you and the trial because the risk
| seems low enough and the reward seems high enough - this is
| just the counter argument.
| jedimastert wrote:
| > dangerous enough to bend the rules of clinical trials to find
| a vaccine faster
|
| Bending ethics regulations because of emergencies is a really
| dangerous precedent, and a bell I'd rather leave unrung.
|
| We don't need to bend the rules when things get bad, we need to
| have better rules. Subtle but massive difference
| tiahura wrote:
| To further your point:
|
| "Moderna's mRNA-1273, which reported a 94.5 percent efficacy
| rate on November 16, had been designed by January 13 [2020].
| This was just two days after the genetic sequence had been made
| public in an act of scientific and humanitarian generosity that
| resulted in China's Yong-Zhen Zhang's being temporarily forced
| out of his lab. In Massachusetts, the Moderna vaccine design
| took all of one weekend. It was completed before China had even
| acknowledged that the disease could be transmitted from human
| to human, more than a week before the first confirmed
| coronavirus case in the United States. By the time the first
| American death was announced a month later, the vaccine had
| already been manufactured and shipped to the National
| Institutes of Health for the beginning of its Phase I clinical
| trial." https://nymag.com/intelligencer/2020/12/moderna-
| covid-19-vac...
|
| It's almost impossible to imagine the devastation that could
| have been averted if the vaccine was released in March 2020.
| fallingknife wrote:
| My point is that they should have allowed a human challenge
| study for faster results, like they are now. Not that they
| should have released an untested vaccine.
| tialaramex wrote:
| Or, as several countries did, you could actually pursue
| elimination and "avert the devastation" without miraculously
| creating millions of doses of untested vaccine, injecting
| them into your population and then crossing your fingers that
| nothing goes wrong.
| onychomys wrote:
| That's only because we know in hindsight that it works,
| though. Phase 1 and 2 trials are important, even though they
| take time, because there's no guarantee that a vaccine
| candidate will be safe and effective. See, for example, a
| couple of Merck candidates that ended up failing [0]. If the
| Moderna one had been released in March 2020 and injected in
| millions of people and then they all got sick anyway, it
| would have been a disaster.
|
| [0] https://www.nbcnews.com/health/health-news/merck-
| discontinue...
| dcolkitt wrote:
| > If the Moderna one had been released in March 2020 and
| injected in millions of people and then they all got sick
| anyway, it would have been a disaster.
|
| Why would that be a disaster? If a bunch of people get
| injected with a placebo, it's at worse neutral. Arguably
| it's better, because we'll collect data faster and move on
| to better vaccines.
| runako wrote:
| > If a bunch of people get injected with a placebo, it's
| at worse neutral.
|
| If they think they got a functional vaccine and change
| their behavior as a result, a placebo has the potential
| to do untold harm all by itself. Further, it erodes loss
| of confidence so that when a working vaccine is
| discovered, it's even harder to get people to take it.
|
| The FDA has faults, but when you look at people's
| objections it boils down to erring on the side of being
| too safe. How much trust would a regulator have if it
| erred on the side of being too unsafe?
| AuryGlenz wrote:
| Vaccines can have negative side effects, some of which
| take a while to show up. Can you imagine how much trust
| would be lost in vaccines if there were some serious side
| effects that started showing up months later? It would be
| a disaster that would ultimately kill way more people
| than the coronavirus.
| selimthegrim wrote:
| The Australian vaccine candidate in trials was giving HIV
| false positives. Imagine that but at scale
| dehrmann wrote:
| I agree with the importance of safety testing, but I
| suspect we could have had vaccines 3 months earlier with
| challenge trials. March was obviously not realistic, and we
| "had" the vaccine in the same way you have a winning bet in
| roulette before the wheel stops spinning. Or that
| Schrodinger still had a living cat.
| qwerty1234599 wrote:
| Imagine if they started challenge trials for the moderna
| vaccine late January 2020, when China went to lockdown.
| Trillions of dollars saved. Oh well.
| whatshisface wrote:
| The trolley problem solution that gets chosen in real life
| situations really seems to be a consistent "last person who
| touched it broke it" policy.
| dehrmann wrote:
| Politically, it's the winning solution.
| jdminhbg wrote:
| > The Copenhagen Interpretation of quantum mechanics says
| that you can have a particle spinning clockwise and
| counterclockwise at the same time - until you look at it, at
| which point it definitely becomes one or the other. The
| theory claims that observing reality fundamentally changes
| it.
|
| > The Copenhagen Interpretation of Ethics says that when you
| observe or interact with a problem in any way, you can be
| blamed for it. At the very least, you are to blame for not
| doing more. Even if you don't make the problem worse, even if
| you make it slightly better, the ethical burden of the
| problem falls on you as soon as you observe it. In
| particular, if you interact with a problem and benefit from
| it, you are a complete monster. I don't subscribe to this
| school of thought, but it seems pretty popular.
|
| https://blog.jaibot.com/the-copenhagen-interpretation-of-
| eth...
| coding123 wrote:
| It's really weird right? On the one hand there's evidence that
| COVID destroys people's lung function even if you end up being
| asymptomatic (aka people not noticing they are sick). On the
| other hand the virus has killed millions so far, and it's going
| to infect people anyway so why not do it intentionally to better
| test vaccines or other fixes.
| 40four wrote:
| Respectfully, saying there is "evidence that COVID can
| _destroy_ asymptomatic people 's lung function" makes no sense.
| I think this safely falls into the FUD category, and it really
| bothers me when I hear things like this.
|
| I seriously doubt there is evidence of this claim. I don't
| think we can go around saying it can _destroy_ people 's lung
| function who show no symptoms. If a person's lung function is
| damaged to the point where we would describe it as 'destroyed',
| then that person is _not_ asymptomatic. That 's a clear
| symptom.
|
| Maybe I misunderstand, and you are saying folks who _start out_
| with no symptoms, then develop damage latter.
|
| Anyway, we _can_ reasonably say that asymptomatic people might
| still receive minor damage to their lungs, and such damage
| could be observed on a CT scan or other test later.
| Irreversible damage? Probably not.
|
| Our bodies are in a constant state of being damaged and
| repairing themselves. If we went through life with the goal of
| avoiding any and all damage to our bodies, that would be a
| terrible way to live.
| richardwhiuk wrote:
| It's unclear whether you can sustain permanent damage, and be
| asymptomatic.
|
| We definitely go through life trying to avoid damaging our
| bodies.
| loveistheanswer wrote:
| >We definitely go through life trying to avoid damaging our
| bodies.
|
| Depends on your risk tolerance.
|
| Some people are agoraphobics, while others are BASE
| jumpers.
| kurthr wrote:
| Well, actually there has been a Scripps paper out there since
| August. It's abstracted here, but it depends on whether you
| believe 'ground glass' abnormalities in lungs represent
| destruction. Certainly, it seems like some "asymptomatic" and
| many mild to moderate cases of COVID cause loss of lung
| function, which could be permanent (e.g. equivalent to having
| a history of pneumonia). That could be enough to make you no-
| longer able to compete at a professional level in sports.
|
| I personally know that a major research hospital is doing
| (unpublished) research on medium to long term effects of
| mild-moderate COVID (non-hospitalized) on lung function and
| that the initial radiological results 3-6mo after symptoms
| are fairly shocking to those running the study.
|
| So there is at least some published evidence from multiple
| sources and there continues to be study on this and based on
| the known action of the disease. Covid "long-termers" do also
| come from mild-moderate and perhaps even "asymptomatic" cases
| so I'm not sure FUD really makes sense here.
|
| https://www.webmd.com/lung/news/20200811/asymptomatic-
| covid-...
|
| https://www.uchealth.com/en/media-room/covid-19/short-and-
| lo...
|
| p.s. these articles were trivial to find and are in no way
| exhaustive.
| 40four wrote:
| Fair enough. I read a couple of similar articles before
| this, but maybe I'm ignorant on the current science. I'll
| check the links out in more detail. But honestly a quick
| look at the WebMD link was not very convincing.
|
| They cite two studies from China in April of last year. One
| study had 16 participants, the other had 4. 20 people total
| studies between the two. Not really enough for any of us to
| make any claims with confidence. WebMD article says, _"
| Nobody knows exactly what those changes mean yet or whether
| they will persist and form scar tissue or simply heal and
| go away after the infection is gone."_
|
| I'm not saying we shouldn't be cautious. But in my opinion,
| if a person was _truly_ asymptomatic then they weren 't
| really _sick_. If it affected them so little that they
| weren 't ever aware they had the virus, it seems like a
| stretch to believe that they would have permanent,
| debilitating damage. It's in the realm of possibility, but
| I'm not going to lose sleep over it.
|
| It's unfortunate asymptomatic people still carry the virus
| & spread it around. But is that quality really unique to
| Covid-19? I doubt it. I suspect it's probably a quality of
| many diseases and sicknesses that we just didn't fully
| appreciate before. How many people every year carry around
| the common cold or the flu with no symptoms, and end up
| spreading it around. Probably a lot.
|
| I'll concede that it's possible to still be harmed by
| Covid, even if you have very few or no symtpoms. Maybe my
| gripe is that I'm just exhausted from hearing talk of Covid
| as if it has 'magical' properties that we all need to be
| afraid of.
| usrusr wrote:
| It really depends on where you define the threshold for
| "symptomatic". If reduced lung perforce is a symptom, then
| it's tautological to say "no damage in the asymptomatic". If
| your threshold is "feeling bad enough to call emergency
| services", then there is plenty of room for massive
| performance loss without ever coming close to that threshold.
|
| People who don't routinely measure athletic performance
| wouldn't even notice losing the equivalent of an entire lung
| lobe as long as the loss doesn't come in a very short time.
| rkangel wrote:
| Because it is unethical to intentionally harm someone for the
| benefit of medical research.
|
| I need to read up on it, but I expect that this challenge trial
| has been given ethical approval because there is now some
| evidence from the larger (non challenge) trials that a
| vaccinated person being exposed has a low risk of harm (for the
| relevant age group).
| da_big_ghey wrote:
| No, not necessarily. People donate kidneys all the time,
| which is a serious procedure with non-negligible chances of
| short- and long-term complications. And non-medically, people
| risk their lives to help others all the time. The difference
| between ethical medical research and the Tuskegee experiments
| is informed consent.
| rkangel wrote:
| Informed consent is by far the most important thing missing
| in the Tuskegee study, but it is not the only thing.
|
| To give one example of the complexity of medical ethics:
| occasionally when running clinical trials, the results are
| so GOOD that it becomes unethical to not stop the trial and
| give the drug to the control group.
| oli5679 wrote:
| "Because it is unethical to intentionally harm someone for
| the benefit of medical research."
|
| People incur additional risk for enjoyment, money or to
| contribute to a social cause in many aspects of life.
|
| If you work as a deep-sea-diver, go skydiving, join the army
| or even frequently drink a lot of alcohol this can increase
| personal risk significantly.
|
| Voluntary challenge trials with well informed, healthy, young
| participants testing novel vaccines and treatments during
| pandemics has a very high net utilitarian impact.
|
| A < 1/10,000 risk for several hundred 20-30 year old
| participants is dwarfed by the death and suffering prevented
| by more quickly having efficacy information.
|
| I'm 27, and shy away from many risks, but signed up for '1
| day sooner' soon after the pandemic reached the UK, and would
| be proud to participate in a challenge trial if needed.
|
| People framing it as 'unethical' should lay out exactly what
| their ethical framework is.
| rkangel wrote:
| > People framing it as 'unethical' should lay out exactly
| what their ethical framework is
|
| I didn't because I thought it clear and obvious from
| context. We're talking about medical ethics, which is a
| well developed field of research and practice. There are
| established procedures in the US and UK to get ethics
| approval for studies and those panels are not just making
| it up as they go along (mostly).
|
| I suppose when I say 'it is unethical' what I really mean
| is 'the medical community in the developed world has come
| to a strong consensus that it is unethical'. Even with
| informed consent.
| jedimastert wrote:
| I think the problem isn't that it's unethical to
| intentionally put someone in harms way, but rather whether
| or not there can be an informed consent. When the virus
| first came up, it was completely unknown that the risk of
| long term impairment might have been, and now we know it
| was/is pretty severe.
| loveistheanswer wrote:
| >When the virus first came up, it was completely unknown
| that the risk of long term impairment might have been,
| and now we know it was/is pretty severe.
|
| Only 10% of positive cases (not including untested
| infections) have any impairment after 3 weeks.
|
| https://covid.joinzoe.com/post/covid-long-
| term?fbclid=IwAR1R...
| benchaney wrote:
| This is incorrect. Informed consent requires that people
| be given the best available information. If that contains
| a lot of unknowns, and they understand that, and consent
| to it, that is completely valid.
| voldacar wrote:
| Not if they're okay with it. Humans harm themselves (or risk
| harm) in pursuit of some perceived higher good all the time,
| anything from smoking a cigarette to fighting in a battle to
| participating in a risky medical experiment. This is just a
| natural and normal part of the human experience. Relax.
| rkangel wrote:
| Individuals are allowed to risk their own lives.
| Organisations can and should be made to jump through many
| hoops before risking the loves of members of the public
| (however well informed). This is a good thing and why
| medics research ethics approval is needed before any
| clinical trial.
| jxcl wrote:
| Interestingly, they only mention vaccination in the second
| phase of the trial. It's not clear to me if this is
| misreported, or they're planning to expose unvaccinated
| healthy people to small amounts of the virus in phase 1.
| vilhelm_s wrote:
| Yes, that's right.
|
| > The first stage of this project will explore the
| feasibility of exposing healthy volunteers to COVID-19. In
| this initial phase, called the Virus Characterisation
| Study, the aim will be to discover the smallest amount of
| virus it takes to cause a person to develop COVID-19. [...]
| Once the characterisation study is completed, this Human
| Challenge Study model can be utilised to conduct COVID-19
| Human Challenge Studies from mid-2021 subject to regulatory
| approvals.
|
| There are some more detailed writeups at
| https://www.gov.uk/government/news/worlds-first-
| coronavirus-... and https://hvivo.com/the-human-challenge-
| programme/
| RalfWausE wrote:
| A long time ago i was a soldier... so, in a sense i signed up
| to have a risk of getting shot (or blown up, stabbed... you
| get the point) for the benefit of my society. How is this
| different?
| rkangel wrote:
| Because we're not talking about the ethics of the
| individuals concerned, we're talking about the ethics of
| the people conducting the study. People volunteering for
| this and the army have made the choice to put others ahead
| of themselves, and (as long as they are suitably informed
| and competent to make the judgement) have the right to make
| it.
|
| The ethics from the other side are broader and subtler -
| they are not of the individual they are of the masses.
| Whether the Army acts ethically by recruiting soldiers and
| sending them to kill and die is a subject of much debate. A
| large number of people think that it is unethical, and that
| is why they protest against war.
| RalfWausE wrote:
| But in this case, the enemy who shall be destroyed is a
| virus, and compared to a human enemy is see no ethical
| problem as long as the "soldiers" in this "campaign" are
| volunteering...
| fasteddie31003 wrote:
| About 4 months too late. Could have saved lives if we had
| challenge trials to get more confidence in our vaccines early on.
| My 2 cents is that society has embraced deontological ethics over
| consequentialism in this pandemic to its detriment. You can't
| bake a cake without cracking some eggs.
| da_big_ghey wrote:
| Interesting take, though I wouldn't call deontological ethics
| the problem here. Rather, it's that someone choosing to become
| infected is regarded as "wrong". It's part of a broader trend
| towards the nanny-state view that people should not be able to
| do "stupid things" that hurt primarily themselves. Another good
| example is drug use: marijuana legalization is really driven
| more by people believing that it is less harmful than by a
| shift towards letting people do what they want. As long as
| people give informed consent, choosing to become infected
| should not be regarded as wrong.
| waterhouse wrote:
| Hmm. Although I think the nanny state is real and I hate it
| as much as anyone, I think this is more about people in FDA-
| like organizations facing perverse incentives: if they
| recommend doing a thing and that thing kills people, then
| they suffer, but if they recommend doing nothing--that is,
| they use the force of the law to stop people from doing
| something--and that leads to people dying, then they do not
| suffer. As a result, they are heavily biased towards
| obstructionism.
|
| There has been some effort to estimate the net impact of the
| FDA, and, for example, to compare the number of people who
| have died due to delays of livesaving drugs vs the worst
| cases of bad drugs getting into the market.
| https://www.fdareview.org/issues/theory-evidence-and-
| example... cites a bunch of studies--many of whose links have
| rotted, so you'll want the Internet Archive, e.g.: http://web
| .archive.org/web/20100603223422/http://www.cato.or... . The
| second link makes a case that the first number is
| significantly higher.
|
| FDA kills. Remember that.
| waterhouse wrote:
| It's a weak-man's deontological ethics. A _serious_
| philosophical debate would be about the ethics of taking 10k
| random people and forcibly or unknowingly injecting them with
| an experimental vaccine that, if successful, might save
| millions. _This_ is about the ethics of allowing _volunteers
| who know the risks_ to do it. I don 't think any sensible
| person, deontological or otherwise, seriously advocates an
| ethical system that would disallow that.
| orangecat wrote:
| It seems to be an underappreciated point that the only
| alternative to challenge trials is to wait long enough for a
| sufficient proportion of the vaccine and control groups to be
| "naturally" exposed to the virus. You can either intentionally
| expose volunteers to the virus with X% probability, or send them
| back into the world and wait for X% of them to be infected. You
| aren't preventing infections by forbidding challenge trials; all
| you're doing is allowing millions more people to become infected
| while you wait for results.
| folli wrote:
| Interesting point of view, but where would you set the
| threshold: a challenge trial for a cancer drug by injecting a
| carcinogen to cause tumor growth? What about viral diseases
| that are much more devastating, e.g. a challenge study for an
| ebola vaccine?
| StavrosK wrote:
| You're assuming that pulling or not pulling the lever is
| morally irrelevant, which may not be the case. To take it to
| the extreme, it's the difference between killing three people
| or waiting for three people to die so you can study them.
|
| In the former case, you're definitely causing excess infections
| (some of which might die, directly due to you).
| martincmartin wrote:
| What if it's killing 3 people, vs waiting for 3,000 to die?
|
| What if it's having a small but non-zero probability of
| killing 1 person, who understands and accepts the risk, vs
| waiting for thousands to die who really don't want to?
| StavrosK wrote:
| Indeed, and apparently ethics boards find it preferable to
| wait for hundreds of thousands to die rather than kill one,
| but it's not entirely unreasonable.
|
| Also, I think the number of total deaths in both branches
| are about the same, as they're only waiting for 100ish
| people to get infected on either arm.
| xyzzyz wrote:
| It was entirely unreasonable, though.
|
| _Also, I think the number of total deaths in both
| branches are about the same, as they 're only waiting for
| 100ish people to get infected on either arm._
|
| When you (entirely unreasonably) restrict your analysis
| only to the experiment subjects, it is true. However, the
| vaccine trials cannot be analyzed in a vacuum: the whole
| reason why these are even a thing is the raging pandemic
| that kills thousands of people every single day. To put
| it in a trolley analogy, the decision is not between high
| speed and low speed trolley that will end up rolling over
| the same number of people. Instead, in the other branch,
| in addition to one slow speed trolley, there are also
| thousands of extra trolleys that you just aren't
| explicitly aware of, but they will roll over their
| victims nonetheless.
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