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Not ethical ...

kenny

Super_Ideal_Rock
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So ... a study in London has signed up 38,500 young healthy people to get paid to be intentionally infected with C19. :-o

Who cares if some die, or suffer lifelong illness?
Pharmaceutical companies and their scumbag stockholders smell a buck. :knockout:

 
Last edited:

elizat

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Mar 23, 2013
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Human challenge trials are not something new.

The ethics have been debated, but there is actually some good work out there by the medical community on standards. Yes, it is a centralized risk to a certain group that have been specially selected based upon criteria, but so long as they are isolated and given appropriate medical care and have given consent as willing, mentally able individuals, I don't see a big issue with it. Here, they are picking individuals least likely to actually have a health problem with the disease that are of legal age. It's a little ugly, but nothing is perfect.

 

seaurchin

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So ... a study in London has signed up 38,500 young healthy people to get paid to be intentionally infected with C19. :-o

Who cares if some die, or suffer lifelong illness?
Pharmaceutical companies and their scumbag stockholders smell a buck. :knockout:

Yikes! Hopefully, they won't get approval.
 

mrs-b

Ideal_Rock
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I can accept it can be argued that it *might* not be unethical. I can't believe it isn't incredibly stupid.

You'd hope those running the test have made it Clear Beyond Misunderstanding what the risks are, but the truth is, there will always be someone who doesn't listen, doesn't read the paperwork, signs without reading, and so on and so on. And of course the drug companies know that. In a group that large, someone will die, someone will be left with disability, someone will have ongoing side effects, someone - and probably many someones - will lose their life as they know it.

Would I let my kid do it? Not in a million years. Not in a million ZILLION years.
 

AllAboardTheBlingTrain

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I don’t necessarily think it’s bad. If I lived alone and in the UK I might even have signed up for this - not for the money, but because it feels necessary. I would want to at least - I hope I would be brave enough to do it, since I’m not a particularly brave person. But I’m young and healthy with no comorbidities and a history of generally tolerating vaccines, including the flu shot, well. Covid has devastated the world over and the only way forward is if we find either a vaccine or a cure, and a preventative is always better than a cure. To me, the risk to the individual is low enough that it’s worth the collective betterment, and human challenge trials have been done before (though the methodology of those can be debatable). It does come down to informed consent in my eyes.
 

yssie

Super_Ideal_Rock
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They will be financially reimbursed for their time,
Here's where the morality fails for me.
As soon as this study introduces financial compensation... Those of fewer means immediately and undeniably have more incentive to take the risk.
 

pearlsngems

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The fact that there is no effective treatment means that anyone who volunteers is heroic, in my opinion. As long as they are fully informed, and provided that health care is provided at no cost (indefinitely) if they become ill-- not merely compensated-- I am not sure it is unethical, given the dire need for an effective vaccine and no way to get one without human trials.

It's true that poorer people may be incentivized to take the risk. Although unrelated, it is also true of poorer people entering the military for the sake of education they could not otherwise afford.
 

lissyflo

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To be honest, I have no idea why human challenge trials are even being considered. We’ve done such a poor job of controlling the virus in the UK that it seems to be running rampant in the general population again. I thought human challenge was used where the chance of naturally contracting a virus was low, to speed up the trial process? Based on the ever increasing lockdown restrictions we’re facing, there must surely be enough live cases of the virus in the general population that it’s not necessary to even consider the merits of deliberate infection of testers? Scientists must stand a reasonable chance of getting feedback on the efficacy just by letting people get on with their daily lives, no deliberate infection necessary. Which is a b****y ridiculous state of affairs given we’ve had the summer to manage this and create a controlled situation where that wasn’t the case.
 

OoohShiny

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I have zero issue with Human Challenge trials in young and healthy volunteers.

I totally support freedom of personal choice and freedom of personal risk assessment, so if someone wants to take a risk for the greater good (or even just for financial gain) I am pleased that they have the opportunity to do so, and that they feel able and willing to participate.


With regards to the levels of risk involved, there is always an element of risk in any medical trials - that's why they hold trials, after all - but the statistics suggest Infection Mortality Rate is extremely low in the young and healthy:




If there are 38,500 people signing up, and if they are all within the 15-24 age group and represent a comprehensive cross-section of society, including those with underlying illnesses and comorbidities, the likelihood of one of them passing away would appear to be 1.7 in 38,500.

Of course, the volunteers will be screened for risks beforehand so it would seem fair to assume that the mortality rate of those within the test will be even (much?) lower than that of the general population.
 

missy

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I am sorry if this offends anyone but better on humans who are willing and able vs animals who have zero choice in the matter.

Though my first thought was what @yssie had written.
 

dk168

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Allegedly, the current Princess Royal, as in Princess Anne, once said there would be no need for testing on animals (for clinical trials of medicinal products for human) if there were sufficient human volunteers.

Being a healthcare professional and work in the pharmaceutical industry, I have no issues with human volunteers for clinical trials, as long as they are made fully aware of the trial design, potential risks to their health, for the trial to be conducted under strict medical supervision including rapid response if anything goes wrong, and that they would be suitably compensated for their time and efforts, as well as future complications, etc., etc...

A lot has been learnt from the disastrous trial of TGN1412 back in 2006, a brief summary can be found via this link: NIBSC - TGN1412 Trial.

I remember this vividly, and one of my ex-colleagues was directly involved with the preparation of the clinical trial materials at the time.

This clinical trial comes to mind every time I hear "cytokine storm" being mentioned to this day.

I would have volunteered to participate in the clinical trials for C19 vaccines; however, I have an underlying health condition that puts me in the vulnerable category and I am outside the qualifying age group.

Well done and good luck to these volunteers I'd say, and I hope it all goes well for them!

DK :))
 

Calliecake

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My niece was telling me this week that her boss is going to be in a clinical trial for the vaccine. He knows all the risks and volunteered to do this. In his case, he definitely isn’t being coerced into doing something he doesn’t want to. I too feel people that are doing this are heroic.
 

dk168

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Clinical trials is a minefield with many rules and regulations, including ethical considerations. There is a sub-industry within the pharma industry devoted to clinical trials.

MHRA, as in UK's Medicines and Healthcare products Regulatory Agency, would not have allowed for this trial to go ahead if they considered it as unethical.

DK :))
 

m-cubed

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Allegedly, the current Princess Royal, as in Princess Anne, once said there would be no need for testing on animals (for clinical trials of medicinal products for human) if there were sufficient human volunteers.

Being a healthcare professional and work in the pharmaceutical industry, I have no issues with human volunteers for clinical trials, as long as they are made fully aware of the trial design, potential risks to their health, for the trial to be conducted under strict medical supervision including rapid response if anything goes wrong, and that they would be suitably compensated for their time and efforts, as well as future complications, etc., etc...

A lot has been learnt from the disastrous trial of TGN1412 back in 2006, a brief summary can be found via this link: NIBSC - TGN1412 Trial.

I remember this vividly, and one of my ex-colleagues was directly involved with the preparation of the clinical trial materials at the time.

This clinical trial comes to mind every time I hear "cytokine storm" being mentioned to this day.

I would have volunteered to participate in the clinical trials for C19 vaccines; however, I have an underlying health condition that puts me in the vulnerable category and I am outside the qualifying age group.

Well done and good luck to these volunteers I'd say, and I hope it all goes well for them!

DK :))
Princess Anne has no clue what she’s talking about. The regulatory authorities are requiring animal studies for vaccine and therapeutic approval.
 

YadaYadaYada

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The Tuskegee Experiments were unethical, in this case people are voluntary signing up knowing the risks involved AND that there is no definite course of treatment.

Of course having compensation does muddy the waters a bit but some people will sign up for clinical trials even if they don’t desperately need the money as a way to make a little extra.
 

dk168

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Princess Anne has no clue what she’s talking about. The regulatory authorities are requiring animal studies for vaccine and therapeutic approval.
AFAIK, pre-clinical safety work, such as determination of LD50 has to be done on animals.

LD = Lethal Dose.

Advancement in science has been able to use lower life forms instead of mammals such as mice in some studies.

DK :))
 

dk168

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The financial incentive for this trial is in the region of £4000 (as per BBC news,10pm, 20th Oct).
About right.

I vaguely remember reading 3k GBP for the TGN1412 trial.

It was a new drug molecule/entity/class, one of the first biologicals to be tested.

DK :))
 

dk168

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Princess Anne has no clue what she’s talking about. The regulatory authorities are requiring animal studies for vaccine and therapeutic approval.
I believe her comment was directed at those who objected to the use of animals in medical science and research.

DK :))
 

OoohShiny

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The financial incentive for this trial is in the region of £4000 (as per BBC news,10pm, 20th Oct).
Really?

That would come in useful right now... lol


I think I've already had it, though!
 

m-cubed

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I believe her comment was directed at those who objected to the use of animals in medical science and research.

DK :))
I’m sure it was, but telling folks something isn’t necessary and won’t occur isn’t helpful When it’s not true.
 

msop04

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I wouldn't disagree except for the number of people I know with long-lasting symptoms or damage, which seems to have no correlation at all to age, preexisting conditions or physical fitness. :(2
These are compensated volunteers. If someone has reservations, then they simply choose not to volunteer.
 

jaaron

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These are compensated volunteers. If someone has reservations, then they simply choose not to volunteer.
I was speaking to the issue of it being a case of only feeling bad for a few days. Just a caveat that for some people, it can unexpectedly end up being something more than that.
 
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