As has been pointed out, standard trials should include older adults (see here for example). In practice, they may not, of course, but they should. If they do, then that complicates the ethical question for me, since now you also have to weigh the risks against the benefit of faster and better controlled results that may not be applicable to the population most in need of protection. You would like to know as early as possible if a vaccine has an unacceptably high rate of adverse reactions in those over 60, say.
This might argue in favor of a simultaneous two-pronged approach, one a challenge trial in healthy younger people and one a conventional trial in a broader range of subjects. If the first prong fails, then the vaccine fails and the second prong can be aborted. If it succeeds, the second prong can continue while manufacturing starts.
Yes, this is discussed extensively in various pieces on the topic over the past month or so. What I am struggling to understand is the apparent lack of ethical concern about a standard trial that includes older people, who are at far higher risk. As I just asked in my previous post, where will I find comments on the dead participants in that trial–the placebo participants who are infected during this huge, slow, trial? I’m genuinely curious about why a challenge trial on young people is more worrying than that. Are some corpses different from others?
That means some of those people die.
I think this is being proposed. I think the important background includes a desire to be prepared for the possibility that we’ll need many trials. There are something like a hundred vaccines under development.
Would you like to be the first person in this thread to discuss living kidney donors and how the ethics of that process relate to challenge trials?
The difference is that in a standard trial, we are not intentionally infecting these older people.
In the control arm of a standard trial, some of the older patients will get infected, but they would have been infected any ways, and they will be treated with standard of care. So the ethical concerns here are substantially reduced. The older patients in the control arm are not facing any new risks, and in fact they might be getting better health care than they might otherwise receive.
In contrast, all the patients in a Challenge Trial are exposed more than they would have been exposed on their own. That introduces risk that they would not already have face.
Now, if there starts to be strong evidence accruing that the vaccine helps, then keeping older patients in the control arm (and not giving them the vaccine) raises a different ethical question. This, however, is an ethical challenge in most randomized-control clinical studies. Often there are rules put in place, or negotiated with regulators as the trial proceeds, where the trial can be brought to end more quickly if there is a strong positive signal, at which time the control arm will get the treatment too.
Yes, but dying from a virus is different than dying from the vaccine. Dying from the vaccine should be much less likely in this case, but we won’t know till we try.
It’s not helpful to repeat that. The challenge is to defend the claim that this matters, or that it matters so much that it’s worth a long tedious discussion with one big question repeatedly ignored.
These are tidy rationalizations. We have no rescue treatment.
You wrote some things about a “kidney donor trial.” My repeated question, which I’ll now give up on, is about the ethics of living kidney donation. The repeatedly ignored question is why/how a surgeon removing a kidney from a healthy living donor is different from a HCW giving SARS-CoV-2 to a healthy young person.
There’s no universally accepted ethical calculus, but it is often felt that causing a death by choosing to take an action is in a different ethical category than deaths that would have occurred without any intervention. So some corpses might be different than others.
As far as I can tell, these corpses (older people who die from adverse reactions in a conventional trial) are morally equivalent to deaths caused by infecting volunteers in a challenge trial. (And all of this applies to morbidity as well, of course.)
Not really, since I’ve decided that both are ethically acceptable if done with good safeguards – and since I have to get back to writing grants to fund SARS-CoV-2 sequencing. (We sequenced a bunch of genomes but whatever stray funds we’d scraped together ran out, so we had to stop sequencing.)
It’s not obvious to me that the risk of a fatal adverse reaction in an elderly recipient of a vaccine for this virus (given its peculiar immunological age profile) is lower than the risk of death for an infected healthy young person. Both are quite small.
However, what would be the ethics of someone donating a kidney for a drug company study that then went on to earn hundreds of millions of dollars from those discoveries while also benefiting thousands or hundreds of thousands of patients? What would the ethics be if they were offering large sums of money for people to participate?
To add to that point, would you be willing to set up a foundation that sought out individuals who would be willing to donate a kidney for research? Personally, I would consider donating a kidney to an individual, but I highly doubt I would donate a kidney to a research group. However, if they offered a million bucks might I reconsider?
I would not personally be motivated to donate a kidney (as a living donor) for research, nor would I be enthusiastic about a foundation to do that. My enthusiasm for living kidney donation is completely related to the benefit to another person, weighed against the risk/cost to the donor. I happen to agree with the founders of the 1DaySooner organization, one of whom (the main person, IIRC) is a living kidney donor who is motivated by what she sees as a clear moral equivalency between living kidney donation and the challenge trial.
Your comments about the profits potentially earned by companies don’t seem relevant here, since that applies regardless of how a trial is organized.
Perhaps you mean to call concerned attention to the size of compensation of volunteers. I agree that this is a concern that should be part of ethical considerations.
I would agree that there is strong commonality between the challenge trial and live kidney donation. However, like with almost everything in life, the devil is in the details. Risking your health for an individual is a bit different than risking your health for a drug company, at least it seems that way at a base human level. When there are profit and career motives in play it adds to the ethical calculus. With live kidney donation to an individual it is a clear trade of risk for the donor and life for the recipient. There isn’t someone profiting millions of dollars, or someone increasing the status within the scientific community because they have a successful scientific study.
It could be that I am seeing demons and witches where there are none, and I may be overly sensitive when it comes to this topic. If nothing else, thanks for responding and I look forward to future discussions.
It doesn’t apply in the case of live kidney donation to an individual. That’s the point I was trying to make.