Are "human challenge" tests actually controversial?

[Bletchleyite]

With mention of these (where you deliberately expose/infect people) being used for the Oxford vaccine, I don't quite get what the issue with them is?

People volunteer to put their life at risk for all sorts of things, e.g. firefighters. I'd volunteer, but I doubt they'd have me at present due to health issues.

moderator note:

This is the story relevant to this thread:

Coronavirus: Encouraging results in vaccine trials

US and UK studies suggest promising early findings in the search for a produce an effective vaccine.

www.bbc.co.uk

In particular this section:

The organisation 1 Day Sooner argues this should not be left to chance.

It is made up of more than 30,000 would-be volunteers in 140 countries who say they are prepared to take part in challenge studies.

The campaign now has the support of more than 100 prominent figures, including 15 Nobel laureates, who have signed an open letter advocating this approach. They say it would involve healthy, young volunteers being deliberately given coronavirus after receiving the vaccine.

 

[ashkeba]

Doing medical tests with an expected very not zero death toll and a higher probability of lasting damage feels unethical, breaking the hippocratic oath and like one step nearer to Dr Mengele. So I would call it unethical.

I question whether most consenting would be fully informed and in sound mind, or instead wanting to be a hero. Firefighters can do things to reduce risk and have high chances to save others, but you would not in some challenge tests. Why would you volunteer for a Russian Roulette?

 

[Yew]

Doing medical tests with an expected very not zero death toll and a higher probability of lasting damage feels unethical, breaking the hippocratic oath and like one step nearer to Dr Mengele. So I would call it unethical.

I question whether most consenting would be fully informed and in sound mind, or instead wanting to be a hero. Why would you volunteer for a Russian Roulette?

Recent sources I've seen suggest the risk is comparable to a kidney transplant operation. We don't consider kidney transplants unethical.

 

[ashkeba]

Recent sources I've seen suggest the risk is comparable to a kidney transplant operation. We don't consider kidney transplants unethical.

But the alternative there for the subject is impaired life and often death. The alternative here is continued health. That seems easy different without disputing the level of risk.

 

[Bletchleyite]

I question whether most consenting would be fully informed and in sound mind, or instead wanting to be a hero. Firefighters can do things to reduce risk and have high chances to save others, but you would not in some challenge tests. Why would you volunteer for a Russian Roulette?

Because it isn't a Russian roulette. The vaccine has already been tested in other ways, this is just another confirmatory test.

If someone wants to "be a hero", why shouldn't they be allowed to make that choice about their own life? Do you also propose to ban other risky behaviours people engage in by choice, such as rock climbing, diving, riding a motorcycle...?

One thing I would say is that there should be no payment for such trials other than receipted expenses, as this avoids anyone being pressured to take part for financial reasons.

 

[Yew]

But the alternative there for the subject is impaired life and often death. The alternative here is continued health. That seems easy different without disputing the level of risk.

Depends which side of the operation you're on. (though I'm not sure if the statement I read was for a donor, or the recipient, I'll read up)

 

[Lloyds siding]

The way this used to be done was that they used 'volunteers' who had already 'volunteered' for death, i.e. members of the armed forces. However the problem is that they are also already selected to be fit, healthy and young, and do not represent the general population.

 

[yorkie]

I don't see how it should be 'controversial' in the current circumstances.

 

[ashkeba]

Because it isn't a Russian roulette. The vaccine has already been tested in other ways, this is just another confirmatory test.

Are we sure none will die or be maimed?

Is your desire to take part thrill-seeking like motorcycling, then?

The way this used to be done was that they used 'volunteers' who had already 'volunteered' for death, i.e. members of the armed forces. However the problem is that they are also already selected to be fit, healthy and young, and do not represent the general population.

But the Rawalpindi and the Porton Down "common cold" sarin experiments are now considered unethical or unlawful.

 

[MikeWM]

As long as they are volunteers, I don't see any issue. Wouldn't do it myself, but my medical history would probably prevent me even if I wanted to.

(Note that there have been many cases in the past where people have been exposed either without their knowledge or without their consent. Clearly that is very wrong).

 

[Domh245]

Are we sure none will die or be maimed?

You don't tend to get to this stage of vaccine development without being fairly confident!

 

[Bletchleyite]

Are we sure none will die or be maimed?

There isn't 100% certainty in any medical trial. Do you consider all medical trials immoral?

Is your desire to take part thrill-seeking like motorcycling, then?

No, it's a view that I'm of relatively low risk, relatively dispensable (as I have no dependents) and a desire to do something useful to help get us a vaccine more quickly, which is truly a holy grail of ending the pandemic.

 

[MikeWM]

You don't tend to get to this stage of vaccine development without being fairly confident!

Problem there is rushing at this sort of speed isn't the ideal, or usual, mechanism of vaccine development. See the swine flu vaccine (which I don't believe actually killed or maimed anyone, but had nasty and permanent side-effects in a small minority).

However, that's not an issue for a trial like this. It may be rather more of an issue depending on how 'compulsory' the vaccine turns out to be for the general population.

 

[John Hunt]

Think back to Edward Jenner in 1796. Without his pioneering work, where would we be now?
He was widely criticised back then but is now considered to be the father of immunology/vaccination.

 

[ashkeba]

There isn't 100% certainty in any medical trial. Do you consider all medical trials immoral?

Not all. But all have been more tested and have lower risk than this.

Edit: also note that I was calling a potentially killer experiment a Russian Roulette and this changed here to questions about my morals.

 

[nlogax]

With mention of these (where you deliberately expose/infect people) being used for the Oxford vaccine, I don't quite get what the issue with them is?

People volunteer to put their life at risk for all sorts of things, e.g. firefighters. I'd volunteer, but I doubt they'd have me at present due to health issues.

I'm a volunteer on an Imperial College research project for Covid testing. If they waved the prospect of a vaccine trial at me that included human challenge I'd probably jump at the chance.

 

[Bletchleyite]

Not all. But all have been more tested and have lower risk than this.

So it's clear you have a low appetite for risk, which is fine. Why do you not feel that others should be allowed to make this choice for themselves? A vaccine one month quicker could quite literally save hundreds of thousands of lives by a relatively small number of people voluntarily taking what is quite a small risk.

 

[Starmill]

I'm not sure exactly what the actual question being asked here is, but there are strict codes for medical ethics, and for clinical trials, for good reasons. Those reasons are in part to protect patients and participants - but they go way beyond that too. I assume that Bletchleyite isn't proposing changing or suspending those.

 

[ashkeba]

So it's clear you have a low appetite for risk, which is fine.

I deny that and wish you well with your title question but I'm out.

 

[Bletchleyite]

I'm not sure exactly what the actual question being asked here is, but there are strict codes for medical ethics, and for clinical trials, for good reasons. Those reasons are in part to protect patients and participants - but they go way beyond that too. I assume that Bletchleyite isn't proposing changing or suspending those.

If any of them prohibit "human challenge" tests, then yes, I would propose they were changed or suspended. I'm not however sure that they do.

However there does seem a lot of objection to doing this despite its potential to accelerate development of the vaccine considerably.

 

[Richard Knight]

If a trial went wrong for any reason, the Principle Investigator is criminally liable, it's not just a Volunteer willing to risk their life, it's peoples career and professional reputation at stake. That's why decisions are made by Independent Ethics Committee, not by the Volunteers or Investigators.

 

[Yew]

So it's clear you have a low appetite for risk, which is fine. Why do you not feel that others should be allowed to make this choice for themselves? A vaccine one month quicker could quite literally save hundreds of thousands of lives by a relatively small number of people voluntarily taking what is quite a small risk.

If anything has been made clear in the last few months, is that there are an awful lot of people who feel that they should be able to control others..

 

[Starmill]

If any of them prohibit "human challenge" tests, then yes, I would propose they were changed or suspended. I'm not however sure that they do.

You don't think it might have been helpful then to have given this at the very least a quick Google, or ideally half an hour's research, before a) creating the thread and b) proceeding to use replies to it to challenge the moral authority of others..? After all this is a deeply sensitive subject - far, far more so than the things we spend more of our time debating here usually.

 

[John Hunt]

I don't personally consider these sort of tests controversial as long as -
1. All of the implications are thoroughly understood by the volunteer.
2. No personal 'glory' is implied; purely the need for the results.
3. Definitely no remuneration - either in cash or in kind. (In the US, unfortunates have been known to take part in trials for $$$.)

I did actually take part in a very well controlled test a few years ago which involved my staying inside an MRI scanner for an uncomfortable period of time and having injections of various drugs. Everything was thoroughly explained to me by the department head and she thanked me, explaining how the results would help future patients. The only benefit I received from this was an earlier than expected discharge from the hospital.