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Seriously ill volunteers after clinical trial treatment

Luke T. said:
And what is the alternative to animal testing? Computer modelling?

I'll bet dollars to donuts that animal testing is more effective.
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I've heard various things suggested: computer modelling, yeah, also in vitro tests, tests on humans (Duh!) and indeed doing without eeeevil pharmaceuticals altogether. Really, anything that means animals don't get harmed, but nothing that seems likely to be effective.
 
Chimps are protected species and are consequently hugely expensive as costs for their husbandry have to be paid for after treatment for the rest of their lives. So they are generally not preferred. The only chimps (of which there are very few now) available for this type of study are maintained in the USA, there are none in Europe.

Even then it wouldn't model the human situation very well since chimp CD28 may not be identical to human CD28 and a chimp anti-CD28 monoclonal antibody would have to be used. What they did do is test it in rats using an anti-rat CD28 antibody and the outcome of that seems to be positive and hence the reason the product was progressesd to the phase 1 safety study.
 
I know. And I'm not at all in favour of testing on chimps. It's just, in this situation, I wish I could do it.

My now-retired business partner was an specialist in laboratory animal medicine, with non-human primates as his special subject, and he could tell a thing or two. (And often did....)

Rolfe.
 
Let's say for the moment that the tests were done by exposing one person first. Who's the lucky person? Which volunteer gets to experience the greater risk (and must therefore be paid more)?

How much longer will the testing be because they have to wait for one person to process it completely?

Given the rarity of extreme reactions like this, changing those aspects of the trials simply isn't worth it. Unless it can be shown that there was prior evidence of serious risk that was covered up or ignored, everyone behaved appropriately, and this was just that one-in-a-million chance coming due at last.

Still, I've never understood why someone would take an untested drug for money.
 
Rolfe, I could be wrong, but everything I've read indicates that these sorts (type I) of trials are often done on the very ill, i.e. an cancer drug might be given to someone with advanced cancer who has exhausted most treatment options. The original link led me to this which confirms this.
 
Melendwyr said:
Still, I've never understood why someone would take an untested drug for money.
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Considering the number of untested chemicals I have been exposed to even without being paid I think it is understandable.
 
Luke T. said:
And what is the alternative to animal testing? Computer modelling?

I'll bet dollars to donuts that animal testing is more effective.
Click to expand...

That depends on exactly what you are doing. If you want to screen a large number of compounds computer modling can be handy since you don't have to make the things.
 
ChristineR said:
Rolfe, I could be wrong, but everything I've read indicates that these sorts (type I) of trials are often done on the very ill, i.e. an cancer drug might be given to someone with advanced cancer who has exhausted most treatment options. The original link led me to this which confirms this.
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No, medicines are first tested for safety in a small group of healthy volunteers (phase 1) as in this study. Then they are tested for efficacy in a small target group who have the disease that the drug intends to treat (phase 2). Then there is a large statistically relevant study to show that the drug really works (phase 3).
 
Capsid said:
No, medicines are first tested for safety in a small group of healthy volunteers (phase 1) as in this study. Then they are tested for efficacy in a small target group who have the disease that the drug intends to treat (phase 2). Then there is a large statistically relevant study to show that the drug really works (phase 3).
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It seems likely that there must be cases where all else having failed, there is nothing to lose by offering a patient an untested drug- ie jumping straight from stage 0 to stage 3.

Statistically, it would be worthless, but there might be the rare case where it actually helps. Obviously one thinks of the early antibiotics.

I would expect legislation to permit this in such extreme cases, where the patient is given the choice.

Does anyone know if such a last resort option exists in UK or US law?
 
Luke T. said:
And what is the alternative to animal testing? Computer modelling?

I'll bet dollars to donuts that animal testing is more effective.
Click to expand...
Johns Hopkins' Altweb has some good information.

I heard one of the (placebo) volunteers on the BBC this morning, who was clearly very shaken up by it. This is bad for science's public image without any help from groups like peta. We should be searching for alternatives to animal testing for that reason alone, to the extent that it's possible.
 
ChristineR said:
Rolfe, I could be wrong, but everything I've read indicates that these sorts (type I) of trials are often done on the very ill, i.e. an cancer drug might be given to someone with advanced cancer who has exhausted most treatment options. The original link led me to this which confirms this.
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Yes, that is very true for some things. But, you test an anti-inflamatory differently than a cancer-drug. Even the best of cancer drugs are often pure misery to take.

Edited to add: But, I think that even with many cancer drugs, they'll give reduced doses to healthy people to look for major problems with people being able to tolerate it.
 
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Soapy Sam said:
It seems likely that there must be cases where all else having failed, there is nothing to lose by offering a patient an untested drug- ie jumping straight from stage 0 to stage 3.

Statistically, it would be worthless, but there might be the rare case where it actually helps. Obviously one thinks of the early antibiotics.

I would expect legislation to permit this in such extreme cases, where the patient is given the choice.

Does anyone know if such a last resort option exists in UK or US law?
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Probably

http://news.bbc.co.uk/1/hi/northern_ireland/4092363.stm
 
mumblethrax said:
Johns Hopkins' Altweb has some good information.

I heard one of the (placebo) volunteers on the BBC this morning, who was clearly very shaken up by it. This is bad for science's public image without any help from groups like peta. We should be searching for alternatives to animal testing for that reason alone, to the extent that it's possible.
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If they'd been testing homeopathic remedies, you can guarantee they would all still be in perfect health.
 
geni said:
That depends on exactly what you are doing. If you want to screen a large number of compounds computer modling can be handy since you don't have to make the things.
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Computational toxicology is a pipedream right now, and it will be for the forseeable future.

Modelling Absorption, Distribution, Metabolism and Excretion (so-called ADME), is hardly any better. There's just not enough data.
 
Capsid said:
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.
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I have recent personal experience with the German drug testing firm Parexel that put these people in the hospital. In December 2005 I traveled to Baltimore to participate in a phase 2 clinical drug trial of a drug intended to allow people with celiac disease (yours truly) to resume eating foods with wheat, rye and barley. (Google AT1001 or Alba Pharmaceuticals)

As part of the intake interview I was introduced to a young lady who was represented to me as a Doctor of Medicine. She proceeded to take my medical history. It came up in our conversation that I am a gay man (quite festive at times, really).

She proceeded to explain her religious views about homosexuality, and then she told me "You're going to be locked up in a ward with other men. If you try anything you will be escorted off the premises." I would not characterize the way that she said this as nice, or pleasant at all. It was more like a threat.

As it turned out my need for daily thyroid supplements disqualified me from their test protocol, which seemed to be based on the assumption that all test participants were hardened criminals and/or sex criminals.

Prior to my traveling 2500 miles to participate in this drug trial I had been assured by an employee of Parexel that all of my travel expenses would be reimbursed. But after I arrived in Baltimore the story had been revised slightly, as there was now a $400 maximum total reimbursement for the 3 cross-country trips that would have been required. They still owe me money.

Since I returned to California I've read other stories about Parexel, involving lost blood samples, mis-labeled blood samples and scheduling snafus that inconvenienced other potential trial participants.

It has occurred to me to wonder if these 6 men that are now seriously ill might be OK right now if a different testing company had been conducting this research.

I certainly would never again volunteer for any drug trial that involved Parexel.
 
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