There is a strong argument for doing a challenge trial, using young people, on this candidate.
Pretty sure that would never make it past an IRB review.
One reason to have the lockdowns.
I shudder at the thought of a government locking people up because a treatment might, at some point in the future, be found.
It is of course besides the point but I find it extremely optimistic to expect that a treatment can be found that will significantly reduce deaths when deaths mostly occur in patients of very advanced age or with significant underlying conditions.
Participating in a trial like this could save many more lives than donating a kidney. And, if you live in e.g. NYC, there's a decent chance you're going to get COVID anyway, trial or no.
Separately from that... y'know, there are currently lots of health care workers taking care of COVID patients—frequently without proper PPE—and getting sick from it. If we as a society have agreed this is worth the risk, why not a challenge trial to develop a vaccine?
I'm honestly a little surprised there's even a debate about this. The choice seems pretty clear to me.
---
[1] https://www.vox.com/future-perfect/2020/4/9/21209593/coronav...
However, you can still get similar information by just dropping the control arm in this trial. Give a bunch of people the vaccine and exposed them to the virus. Sure it's not as good as having an untreated control arm, but you're also reducing the risk of someone in the control group dying.
In addition, the mechanism of vaccines is very well know. You can vaccinate and measure antibody formation.
You could still develop a vaccine without a control and have confidence that it works.
Source: I once participated in a phase III open-label single-arm trial.
The standard is two well controlled studies, but additional open label trials may be used to address specific health authority concerns.
If you are interested, you can look up the other trials the drug may have gone through.
I haven't seen the Vox article, but if that's what they said, it's total bullshit and irresponsible journalism, and I'd request that you do your part by not repeating that.
The first kidney donation was in 1954. We have 66 years worth of data--plenty of time for many kidney donors to live out their lives and have the problems caused by kidney donation, so we have a pretty good idea of what the long-term effects of kidney donation are.
We don't know what the long-term effects of coronavirus are because nobody has had it and then lived long term. The first case we know of was in November 2019--five months ago. Vox can't say that "if you're young, the risk of death is about equal to a kidney donation", because we do not know what the risks are. If scientists infected a bunch of 20 year olds with Covid in 2020 and by 2050, 40% of them die of lung cancer before the age of 50, is that something you'd be cool with? Because that might be reality--it's impossible to know.
To be clear, I'm not saying Covid-19 causes lung cancer. I'm saying we cannot possibly know ANYTHING about the long term effect of Covid-19. We shouldn't assume that it causes lung cancer, but we also shouldn't assume it's no more dangerous than a kidney donation. We shouldn't assume, period. So statements like, "if you're young, the risk of death is about equal to a kidney donation" are lies. And I would implore you to not spread that misinformation because it potentially has deadly consequences.
> If scientists infected a bunch of 20 year olds with Covid in 2020 and by 2050, 40% of them die of lung cancer before the age of 50, is that something you'd be cool with?
If it saves the lives of a bunch of nurses in the process? I don't know—I think I'm cool with a possibility of it, yes. Especially when those same people could also catch the virus naturally.
Also, I edited my original post to add a link to the Vox article. It's quite a bit longer / more expansive, and worth a read.
I had gone through my post and removed all the places where I called it "lies" because I intended to say that this arose from ignorance rather than malice, albeit irresponsible ignorance from journalists whose responsibility it is to share information. I must have missed that one, my apologies for the accusation.
> We don't know the long-term effects of 5G either.
Geez, did you get this from Vox too? The bands used for 5G didn't just spring into existence: they've been around and used[1], albeit deployed on much smaller scales than 5G will be. We have long-term data on the effects of adjacent bands, and a few different ways of modeling how electromagnetic radiation affects the body. The data we have is certainly from much smaller deployments than 5G will be, so it's true we don't know all the long-term effects of 5G, but we at least have enough data to put some bounds on how horribly 5G could go wrong. For starters, we know that it doesn't have a 40% chance of killing everyone exposed to it in the next 30 years with lung cancer, because an effect that large would show up even in the more limited data we already have. And if it does turn out to cause some problem with even a minute fraction of that severity, we can turn off the 5G and stop the cause of the problem.
We don't even have a clear lock on the short term mortality rate of coronavirus and we can't stop the spread with the flip of a switch. Where, exactly, is your confidence coming from here?
> If it saves the lives of a bunch of nurses in the process? I don't know—I think I'm cool with a possibility of it, yes.
> Especially when those same people could also catch the virus naturally.
The worst-hit place in the US is NYC, with 141,754 confirmed cases currently. Even if we assume unconfirmed cases 5 times that, we're still talking single-digit percentages of the population infected. And cases are going down. So yes, people could catch the virus naturally, or, as is much more likely, they could not catch the virus, if we continue taking the recommended measures that are working.
Certainly populations like health workers working directly with the infected are at much higher risk than the general population, but there's still a very significant chance they don't get infected. And even if the chance of them not getting infected were negligible, the solution would be to give them proper PPE, training, and other protections, not to say, "Hey you're probably going to get it any way, so let's just deliberately infect you to test vaccines that may not work."
Wasn't you point just that we shouldn't assume? I know that there are models looking at a possibility for only 1% of cases being confirmed. That's been in Sweden and not NYC, but just throwing a 5 out there doesn't make a lot of sense.
It's true that 5 was just a number out of a hat, but I think you'd have a hard time picking a big enough number that it invalidates my point. Even if you pick 100 as you're claiming, you're still looking at a double-digit percentage chance of not getting infected, which you're taking away from people by deliberately infecting them.
Incidentally, saying "If we assume" is different from saying "We can assume". I'm not assuming that number, I'm merely highlighting it as one of the many possibilities.
Based on the number of people testing positive for the antibodies ([0] something like ~21% of random tests in New York), and given that the average estimated R0 is really high, I think ~100% of people being infected by this time next year is a pretty reasonable assumption. This also indicates that the death rate we previously estimated is much lower in reality. Infecting a few more young, healthy people and supervising their health seems a pretty good deal for the world at large.
[0] https://www.livescience.com/covid-antibody-test-results-new-...
There are actually steps we can take to speed this up without abandoning medical ethics. It certainly makes sense to have the first human trials be on medical workers, because it has the highest chance of producing benefit for them, and the results will be clearer in populations with a higher infection rate.
But we're not talking about those because you guys would rather talk about injecting people with coronavirus based on a poor understanding of both risk and medical ethics.
> You cannot tell me what effect 5G will have on the body in 50 years, because no one has tested it. Who knows what might happen?
And y'know what? Technically speaking, he or she is absolutely right: despite our best modelling, we can't really know what deploying 5G at this scale will do in 50 years, and we won't know until 50 years from now! All we can say is, this are what we've extrapolated from the models we have.
Is there specific evidence to suggest that COVID-19 will cause extremely high rates of lung cancer in 30 years? If not, we're just in the messy realm of "anything could happen," which is both true and not particularly useful.
I think you have to compare the (very real!) risks of a challenge trial with the risks of not doing a challenge trial. Maybe it does only speed up development by two months, and the number of health care workers and other members of the public who will die in that time is low enough to not be worth risking the lives of study participants. But that is a question we need to actually look at and consider!
Perhaps not "extremely high", but there are lots of other cases where viruses attacking human tissue much less severely are known to cause cancer. HSV causing cervical cancer is probably the most obvious example, but there are many others.
This is well outside my area of expertise, but what I've read leads me to believe that the way viruses reproduce is particularly prone to resulting in mutations in the human cells it attacks.
It would surprise me a bit if Covid19 didn't increase the chance of cancer at some level, although it might be a very small effect.
> I think you have to compare the (very real!) risks of a challenge trial with the risks of not doing a challenge trial. Maybe it does only speed up development by two months, and the number of health care workers and other members of the public who will die in that time is low enough to not be worth risking the lives of study participants. But that is a question we need to actually look at and consider!
That's true. No questions should ever be off the table.
But it didn't sound much like asking a question when you said upthread, "I'm honestly a little surprised there's even a debate about this. The choice seems pretty clear to me." That's why I responded the way I did.
I didn't mean to imply a cost-benefit analysis shouldn't be done.
That said, I feel like your points are a bit overstated. We now have 66 years worth of Kidney transplant data to show it's safe for both parties, but a lot of people needed to participate in what was a new, risk, experimental surgery to get us to this point.
At some point people have to be willing to take a little bit of risk to get data that could save untold lives and relieve unquantifiable suffering.
Additionally, if COVID-19 does indeed have some horrible long term effect, the cost us having less data or less valuable data now will have a much larger consequence than could ever be suffered by these volunteers.
Uh, technically that's true, but the risks are not the same. The first successful kidney removal (nephrectomy) was in 1869. It wasn't for a donation, it was for a woman suffering an uncloseable fistula which, without the operation, would have killed her. So what exactly was she risking? By the time someone was allowed to volunteer to donate a kidney in 1954, nephrectomy had the better part of a century's worth of data and refinement of technique.
Compare this to the risk you're proposing: With current measures which seem to be working, there's a good chance that most people don't get infected. So you're proposing that healthy individuals who would likely not contract the virus, be intentionally infected with a disease which he only have an approximate mortality rate for, and that we have no idea of the long-term effects of.
Surely you can see how the first risk fits withing "First, do no harm", while the risk you're proposing simply doesn't.
If the vaccine works then we'll all be dying of lung cancer in 30 years.
If it's obvious then it should be equally obvious that a comparison with something that has long term knowledge is nonsensical.
2. It's apparently not obvious, because people on this thread seem to not have thought of it, and when I pointed it out, they've argued vehemently against it.
One of the issues with vaccine development is that vaccines can result in worse infections [1].
If the issue was just “this might not work, but it won’t cause any harm”. You would obviously give this to healthcare workers immediately. But that does not appear to be the case.
So... a challenge trial at phase III will still have risks. Right now, I don’t think we have any vaccines ready to enter phase III?
COVID19 does seem to be actively spreading in the population currently. So I don’t think there would be an issue finding participants for a phase III trial.
At the point that we’re ready for phase III trials. If there is no population where COVID19 is actively spreading, perhaps challenge trials could be considered?
I realize for many that won't be an option. But with the way things are going in America right now, I'm afraid it might not be an option for anyone; it may be a requirement just to get a job or go to school. That frightens me.
That was approved in Europe but not the US.
1 in 55000 people who took pandemrix got narcolepsy.
The risk is small, but the outcome is a severe debilitating illness that requires constant care for the rest of their life.
We may decide that risk is acceptable, but we need to know about it.
It's just vaccinate then let them do normal UK life.
It's different from a phase 1 study when you are testing on healthy volounteers. This would mean deliberately infecting people with a largely unknown virus after vaccination with a vaccine whose efficacy is still not yet determined fully (in fact, it would be to determine its efficacy).
There needs to be a reasonable amount of risk taken in research, otherwise we will find it impossible to make progress.
If you ask under-40y/o non-violent offenders with >10yr sentence and say a $10k payout and guaranteed presidential pardon upon completion of the trial I’m sure there would be some takers.
Yes that’s crazy and I do know the governments history of shady vaccine testing, but we are facing a pandemic and each day sooner that we have a vaccine will be many lives saved.
the highest-profile prison experiments in the US were Project MKUltra, in which prisoners were injected with high doses of LSD, the Stateville Penitentiary Malaria Study, and some experiments with radioactive isotopes.
offering prisoners their freedom in exchange for participating in dangerous or harmful trials was widely viewed as coercive, and contrary to the Nuremberg code of medical voluntary consent established after the horrors of Nazi experimentation.
why should it be better to use prisoners than young, healthy volunteers? are their lives cheaper and expendible because they committed non-violent offenses? no IRB would sign off on that, and if you're bypassing IRBs anyway just use young people who think they're invincible..
The Australian army tested anti-malarials with good intent and caused huge mental harms (they are pretty psychologically active and can trigger suicide ideation)
The US army has form for testing on recruits without adequate consent or information
Overall, the whole "for the good of humanity" story here is that the consent is weak, the support is weak, the costs are not borne equally. I would not advise any young person to be guilt-tripped into volunteering for this.
The track record here is very poor
You are simply ignoring the responsibility of the vaccine maker of potentially not going through the adequate steps.
A better equivalence would be the question, how should your hypothetical army be equipped and trained. And would the people doing/deciding that be responsible for the choices made. I would understand you saying, it doesn't matter we are under attack.
Agreed. And if standard training takes 12 months and you're being invaded now, what do you do?
We are allowing "essential" workers to be exposed to COVID. Who could be more of an essential worker than a vaccine trial participant right now?
https://pubmed.ncbi.nlm.nih.gov/12725690/
Just about the last people you’d want to risk that kind of vaccine trial on are healthcare workers, who are already in short supply.
I said that there’s plenty of incidental exposure already: healthcare workers, yes, but also nearly everyone who’s leaving the home too. It is literally a pandemic!
This point is actually made in the article itself: they want to get it done while and where there’s community transmission to avoid the ethical fraught ness of a challenge trial.
For similar reasons, challenge trials also weren’t done for AIDS PrEP, since there were groups with enough lifestyle exposure to power a study.
[1] https://www.biorxiv.org/content/10.1101/2020.04.17.046375v1
Also - this would be less risky than going to space.
My instinct says >50% of soldiers between 20-30 would instantly volunteer for this. Probably much higher, like 80%. Especially those unmarried.
There would be no lack of fit volunteers.
Its ethically problematic obviously, but so is asking grocery store workers to stock shelves as 'essential workers' during a pandemic when they have no PPE.
I think probably there's a 100% chance that so-called 'essential workers' who are not medical staff will die from Coronavirus due to the pandemic.
The rate of death among the 'very young' is exceedingly low, and I think there were always complications.
If we can narrow it to 19-26 year old, super healthy, without complications ... I think the 'possibility of harm' would be quite low.
It's not beyond the realm of ethical consideration.
Now - remove some ethnical barriers - such as what drug companies used to do by testing drugs in Africa, or what authoritarian governments do all the time (aka China) and you'll have this done in a heartbeat.
I think China/CCP wouldn't think twice about trying this on young men in jail. Is my cynical take.
If the Oxford researchers made trials on Syrian kids in a refugee camp, in exchange for $100, I suppose more people would see a problem here.
I find the attitude puzzling that people are willing to value vague abstractions like "integrity of the community" over thousands of lives.
The reason for the vaccine research protocol we're settled on, is the ubiquity of wanna-be Pasteurs, and dearth of the real ones.
On a separate note. We have deprived ourselves of basic human rights under the premise, that lives are worth any economic outcome of shut down. Where I live, premeditated spreading of the Covid is considered by law an act of terrorism. Officially vetted challenge trials just don't add up.