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Seriously ill volunteers after clinical trial treatment

Capsid

Graduate Poster
Capsid
Joined
Apr 21, 2004
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I'm surprised this hasn't been posted earlier.

http://news.bbc.co.uk/1/hi/england/london/4808836.stm

Six men are serioulsy ill after receiving an anti-inflammatory drug in a phase 1 safety study in London, UK. I understand that the drug is a monoclonal antibody. Two men who got a placebo were not affected. Animal testing did not show this effect.

The fallout from this could be that volunteers will be very hard to come by.
 
I'm just waiting for the PETA people to start gloating that "animal testing doesn't work." I suspect that volunteers will still come forward - students will do anything for a bit of spare cash.

It's all very unfortunate. (Although the devil in me is wondering how the placebo group are getting on)
 
richardm said:
I'm just waiting for the PETA people to start gloating that "animal testing doesn't work." I suspect that volunteers will still come forward - students will do anything for a bit of spare cash.
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I would say, if anything, this calls for more animal testing.

richardm said:
It's all very unfortunate. (Although the devil in me is wondering how the placebo group are getting on)
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Probably in a bar somewhere.
 
But within hours of taking it on Monday, six volunteers had to be admitted to intensive care
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Is it only hindsight which makes me think, why would they give the drugs to all six people at the same time? I am assuming that this was a untested drug which had not been given to humans before.

The animal rights campaigners will see this as proof that that animal testing is flawed and without justification (it is neither).
 
Capsid said:
The fallout from this could be that volunteers will be very hard to come by.
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As long as there are students short of money it will be posible to get test subjects.
 
I suspect the drug would not have been tested on non-human primates before this stage. Sad though it is to say, I wonder if more primate testing might have prevented something like this.

Rolfe.
 
I found out a bit more. It's a fully humanised monoclonal antibody specific for CD28, a surface molecule involved in activation of T cells. I'm not sure what went wrong in the clinical trial. Perhaps a human monoclonal would only stimulate human T cells (not predicted by animal testing) and in this case has pushed the T cell activation into overdrive.

Are the clinical symptoms consistent with this?
 
It sounds like this whatever-it-is has disabled the self-recognition system?

***shudder***
 
Or, OTOH...

http://www.medicalnewstoday.com/healthnews.php?newsid=39640
...This bizarre complication could be caused by one of several factors. Perhaps something went wrong in the manufacturing of the drug, it could have been contaminated, the patients could have been contaminated by something in the hospital (doubtful as the placebo patients were OK), there could have been an error in the dosage - or it could be something completely unrelated to anything we have knowledge of.
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It's early days yet.
 
I can vaguely recall something similar happening a few years ago. This is why these sorts of trials are often done on people who are already quite sick, and also part of why these guys are paid.

Hopefully, they'll recover.
 
jj said:
It sounds like this whatever-it-is has disabled the self-recognition system?

***shudder***
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I don't think so. A disease like rheumatoid arthritis, for which this drug was being tested, is the result of the body's self-recognition system already being disabled. Thus "auto-immune" disease. These drugs are designed to suppress the immune system. So it's a self-recognition system disabler disabler. :)

My wife has RA. She's taking methotrexane, which is also a heavy duty cancer drug.
 
Sounds more like a massive anaphylactic reaction, but there are many, many possibilities. I'm just stating one from my own experience and knowledge (which is far from complete or comprehensive).

Wonder if there's a possibility we've found a substance that everyone is allergic to?
 
richardm said:
I'm just waiting for the PETA people to start gloating that "animal testing doesn't work." I suspect that volunteers will still come forward - students will do anything for a bit of spare cash.
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And what is the alternative to animal testing? Computer modelling?

I'll bet dollars to donuts that animal testing is more effective.
 
Huntsman said:
Sounds more like a massive anaphylactic reaction, but there are many, many possibilities. I'm just stating one from my own experience and knowledge (which is far from complete or comprehensive).

Wonder if there's a possibility we've found a substance that everyone is allergic to?
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Bio-weapon...
 
Luke T. said:
I don't think so. A disease like rheumatoid arthritis, for which this drug was being tested, is the result of the body's self-recognition system already being disabled. Thus "auto-immune" disease. These drugs are designed to suppress the immune system. So it's a self-recognition system disabler disabler. :)

My wife has RA. She's taking methotrexane, which is also a heavy duty cancer drug.
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Well, yeah, except that it seems that there are kinds of cells that record our own antigens and destroy the antigens generated for our own bodies. If this gadget destroyed them ....... Cringe
 
Huntsman said:
Sounds more like a massive anaphylactic reaction, but there are many, many possibilities. I'm just stating one from my own experience and knowledge (which is far from complete or comprehensive).

Wonder if there's a possibility we've found a substance that everyone is allergic to?
Click to expand...

Are there weapons developers around the world pricking up their ears at this?
 
ChristineR said:
I can vaguely recall something similar happening a few years ago. This is why these sorts of trials are often done on people who are already quite sick, and also part of why these guys are paid.

Hopefully, they'll recover.
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Something happened in Wales some years ago, and someone died, but I can't find any references.

Christine, you are 100% wrong about this trial. It wasn't a "clinical trial", although a couple of people on TV called it that. It was a "pre-clinical trial", the very first step when a drug is given for the first time to humans to see what happens.

These people have to be young, healthy, and male (to be sure they're not pregnant). Usually they're students, trying to earn a few honest quid to supplement their student loans. The purpose of the trial isn't to see if the drug works or not, these people are not ill. It's just to get some basic pharmacokinetic data such as how long does it take to be eliminated from the body, and are there any little side effects cropping up.

The latter category is expected, if it happens, to be things like headaches or rashes. Critical illness is a bit of a downer, to put it mildly.

The tragedy is that these are young, previously fit and healthy guys, who didn't for a minute consider they were taking any serious risk enrolling for this exercise.

Personally, I'd dearly love to inject a couple of chimpanzees with this and see what happens. Just how close to human do you have to get before this reaction manifests? (Assuming it really was an adverse reaction, and not a contamination or overdose scenario.)

Rolfe.
 
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