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TETENAL · Mar 16, 2006, 08:07 AM

It seems like there was a drug test accident in London. Two test persons are almost dead and four others are in critical condition. The tests were done for a German pharmaceutical company. The Sun has all the horrible details:

http://www.thesun.co.uk/article/0,,2-2006120434,00.html

We had needles inserted in both arms with valve devices so they could inject drugs and take blood for tests. [...] The test ward turned into a living hell minutes after we were injected. The men went down like dominoes.
First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode.
After that they started fainting, vomiting and writhing around in their beds

Binarymix · Mar 16, 2006, 08:14 AM

Sad.

Doofy · Mar 16, 2006, 08:14 AM

Here's another source for those who don't trust The Sun:

http://news.bbc.co.uk/1/hi/england/london/4813478.stm

analogika · Mar 16, 2006, 08:23 AM

Press release from TeGenero: http://www.tegenero.com/news/stateme...1412/index.php

badidea · Mar 16, 2006, 08:31 AM

"test persons almost explode"

???

analogika · Mar 16, 2006, 08:52 AM

Read the links.

Extreme swelling of, among other things, the head, with loss of internal organ function.

It's the Sun, yeah, but they're not that far off, in this one case...

Credible link (in German): http://www.tagesschau.de/aktuell/mel...6_REF3,00.html

TETENAL · Mar 16, 2006, 08:53 AM

Originally Posted by analogika

Press release from TeGenero: http://www.tegenero.com/news/stateme...1412/index.php

I get a 404 for the whole site.

analogika · Mar 16, 2006, 08:56 AM

Originally Posted by TETENAL

I get a 404 for the whole site.

Are you on a proxy?

Site works fine here. Link reloads fine, domain root is fine.

www.tegenero.com doesn't work for you?

TETENAL · Mar 16, 2006, 09:02 AM

Originally Posted by analogika

www.tegenero.com doesn't work for you?

No, doesn't work for me. I just get the standard 1&1 404-screen (which is sort of scary in itself – a pharmaceutical company that hosts its website at 1&1). I'm not aware of being on a proxy.

ghporter · Mar 16, 2006, 09:02 AM

I think the term "accident" is inappropriate. The test was obviously not successful, and of course the results were unintentional, but to say that there was an "accident" implies that someone did something unplanned that caused the extremely negative effects in the test subjects, which is not the case. It would be better to say that the test proved disasterous for the experimental subjects than to say that an accident occurred.

Chuckit · Mar 16, 2006, 09:37 AM

accident |ˌøksədənt| noun 1 an unfortunate incident that happens unexpectedly and unintentionally, typically resulting in damage or injury

Sounds correct to me.

wdlove · Mar 16, 2006, 09:40 AM

I hope that this was listed as some of the risks when they signed the consent form. There is to be full disclosure for a research study.

Chuckit · Mar 16, 2006, 09:45 AM

I don't think they realized there was a risk of sudden and immediate incapacitation.

von Wrangell · 10:04 AM

http://www.contrast.org/hillsborough...story-html.htm

http://www.contrast.org/hillsborough/history/media.shtm

http://www.contrast.org/hillsborough...t-the-sun.shtm

http://en.wikipedia.org/wiki/Hillsbo..._Sun_newspaper

http://www.liverpoolfc.tv/lfc_story/memorial/

tooki · Mar 16, 2006, 10:01 AM

It's a new drug, a new chemical compound that no human body has ever come into contact with. It think it'd be foolish to assume anything other than that ALL outcomes are possible.

tooki

analogika · Mar 16, 2006, 10:11 AM

Originally Posted by TETENAL

No, doesn't work for me. I just get the standard 1&1 404-screen (which is sort of scary in itself – a pharmaceutical company that hosts its website at 1&1). I'm not aware of being on a proxy.

Are YOU on 1&1?

Oddly, their website *does* appear to be hosted on einsundeins.de, but it works perfectly here - both .com and .de

Big Mac · Mar 16, 2006, 10:37 AM

Sounds like there wasn't enough animal testing on this particular drug.

::maroma:: · Mar 16, 2006, 10:58 AM

Originally Posted by Big Mac

Sounds like there wasn't enough animal testing on this particular drug.

Sure there was, the animals were just human animals.

I Bent My Wookiee · Mar 16, 2006, 11:07 AM

The sad thing is they probably can't sue as they would have signed a bunch of papers before they took any meds.

Binarymix · Mar 16, 2006, 11:11 AM

Originally Posted by I Bent My Wookiee

The sad thing is they probably can't sue as they would have signed a bunch of papers before they took any meds.

I'm sure there's a loophole if the outcome is death.

Person Man · Mar 16, 2006, 11:45 AM

Originally Posted by I Bent My Wookiee

The sad thing is they probably can't sue as they would have signed a bunch of papers before they took any meds.

It's a clinical trial. They were probably enrolled in it because they were at the end of conventional therapy and they were going to die anyway, so why not try a new experimental drug which may help them, or if not them, at least help others with the same illness.

The risks and benefits were probably explained to them beforehand. If anyone tried to sue, I doubt it would be successful.

Person Man · Mar 16, 2006, 11:48 AM

Originally Posted by Binarymix

I'm sure there's a loophole if the outcome is death.

Nope.

In many trials of that nature, death is included as a possible outcome of the trial. They made the decision to participate fully aware of that possibility. And as I said above, the fact that they're in a cancer clinical trial means that they failed regular therapy (meaning it wasn't effective for them) and are probably going to die anyway.

seanc · Mar 16, 2006, 11:54 AM

Originally Posted by Big Mac

Sounds like there wasn't enough animal testing on this particular drug.

I heard on the news sometime recently, maybe this morning, that even some of the animals died during testing because of this drug but I could be wrong.

I Bent My Wookiee · Mar 16, 2006, 11:57 AM

Originally Posted by Person Man

Nope.

In many trials of that nature, death is included as a possible outcome of the trial. They made the decision to participate fully aware of that possibility. And as I said above, the fact that they're in a cancer clinical trial means that they failed regular therapy (meaning it wasn't effective for them) and are probably going to die anyway.

If I am dead the last thing I will worry about is money.

I am talking about suing them because they practically tortured these people.

TETENAL · Mar 16, 2006, 12:00 PM

Originally Posted by Person Man

And as I said above, the fact that they're in a cancer clinical trial means that they failed regular therapy (meaning it wasn't effective for them) and are probably going to die anyway.

What are you talking about? The test subjects didn't have cancer.

ghporter · Mar 16, 2006, 12:02 PM

Originally Posted by Chuckit

accident |ˌøksədənt| noun 1 an unfortunate incident that happens unexpectedly and unintentionally, typically resulting in damage or injury

Sounds correct to me.

Testing ANY new drug carries risks, and "informed consent," an ethical and in most countries legal requirement before using human subjects, requires that any forseeable risks be detailed for potential subjects BEFORE they take part in the tests. I even had to sign an "informed consent" release when I was a subject in a memory test that involved nothing but looking at pictures and determining whether I recalled them or not.

Calling the events an accident says something other than unanticipated side effects happened, as in the administration apparatus failed causing serious injuries. In fact it was unexpected serious side effects, not mechanical issues that happened.

This is no horror movie; it's one of the risks of medical testing, and to say that this was an accident is to suggest that there was neither knowledge of potential negative effects (and since the test was actually on modified monoclonal antibodies, the first potential negative effect is "death through destruction of the immune system"), nor any information presented to the subjects about such potential risks. Since this sort of unfortunate and life threatening result of human testing is extremely rare, it is indeed newsworthy. But using pejorative terms like "accident" reduces the seriousness of either the testing or the subjects' injuries.

tooki · Mar 16, 2006, 12:35 PM

Originally Posted by Person Man

It's a clinical trial. They were probably enrolled in it because they were at the end of conventional therapy and they were going to die anyway

Bzzzt!

Read up before you post!

This was a phase 1 trial, which means it is conducted on healthy volunteers to test for side effects (NOT to test for efficacy).

It also wasn't a cancer trial in any way.

Originally Posted by Big Mac

Sounds like there wasn't enough animal testing on this particular drug.

It doesn't matter how much animal testing is done, there are some responses that simply do not show up except on humans. Some responses are highly species-specific.

I found it funny that on the comments to the Sun article in the OP, one of the comments was from a PETAphile, saying "see? this proves animal testing is worthless!"

In fact, if animal testing weren't done, far more phase 1 trials would go awry. What this does prove is that animal testing does not prove safety in humans. It merely indicates a lower likelihood of adverse effects.

As for the ability to sue: it depends on what the determined cause of the problem is. You cannot enforce a contract that is illegal, and it is illegal to be, for example, criminally negligent. Therefore, if the testing firm or the pharmaceutical company did something illegal that led to this event, the contract limiting liability is void. But if the cause of the adverse reaction really was just a completely unexpected side effect that nobody anticipated, then it's possible that suing would fail.

Originally Posted by I Bent My Wookiee

I am talking about suing them because they practically tortured these people.

The primary meaning of torture is to cause deliberate harm as punishment or to coerce someone into doing something. I think it is highly unlikely that a pharmaceutical company would seek to deliberately harm the people directly responsible for part of the process for gaining approval for a drug they wish to market.

Did this result in obvious terrible agony? Clearly. But that doesn't make it torture.

tooki

Chuckit · Mar 16, 2006, 12:45 PM

Originally Posted by ghporter

Calling the events an accident says something other than unanticipated side effects happened, as in the administration apparatus failed causing serious injuries. In fact it was unexpected serious side effects, not mechanical issues that happened.

Find the word "mechanical" in this definition:

accident |ˌøksədənt| noun 1 an unfortunate incident that happens unexpectedly and unintentionally, typically resulting in damage or injury

It ain't there. The results were, in your own words, both unexpected and unintentional. They were also unfortunate and resulted in injury. You're saying po-tay-to, I'm saying po-tah-to.

BigBadWolf · Mar 16, 2006, 12:59 PM

I love CNN's picture of the doctor:

http://edition.cnn.com/2006/HEALTH/03/16/uk.clinical/

meelk · Mar 16, 2006, 01:26 PM

hey, I felt just like this when I had a gallbladder attack :x

I Bent My Wookiee · Mar 16, 2006, 01:31 PM

Originally Posted by BigBadWolf

I love CNN's picture of the doctor:

http://edition.cnn.com/2006/HEALTH/03/16/uk.clinical/

He looks like a mad Nazi scientist so I guess they should be too surprised things went sour.

ghporter · Mar 16, 2006, 01:39 PM

It reminds me of the picture of the chief of the British Explosives Establishment, who was very much in the headlines after the bombing of the Pan Am flight over Lockerbie, Scotland. The guy looked like something had blown up in his face. A VERY unfortunate image to associate with a very serious situation. Spokespeople MUST know how they appear so that their appearance does not detract from what they are saying. Otherwise wags like us will make fun of them and not listen to them.

I Bent My Wookiee · Mar 16, 2006, 01:45 PM

Originally Posted by BigBadWolf

I love CNN's picture of the doctor:

http://edition.cnn.com/2006/HEALTH/03/16/uk.clinical/

OK I take it back, he looks more like Dr. Strangelove.

::maroma:: · Mar 16, 2006, 02:49 PM

Originally Posted by BigBadWolf

I love CNN's picture of the doctor:

Haha! They just had to light him from underneath to give him that super mad scientist look. Kudos to the photographer.

Person Man · Mar 16, 2006, 03:00 PM

Originally Posted by tooki

Bzzzt!

Read up before you post!

This was a phase 1 trial, which means it is conducted on healthy volunteers to test for side effects (NOT to test for efficacy).

It also wasn't a cancer trial in any way.

I just saw that it would be used for leukemia and assumed it was a cancer trial.

Obviously if people reacted this badly to the drug, then they need to look at it more carefully to determine what happened. But my guess is that it won't progress beyond phase 1 trials.

Nai no Kami · Mar 16, 2006, 03:43 PM

Originally Posted by I Bent My Wookiee

OK I take it back, he looks more like Dr. Strangelove.

That movie rules.

Doofy · Mar 16, 2006, 04:23 PM

Originally Posted by Person Man

It's a clinical trial. They were probably enrolled in it because they were at the end of conventional therapy and they were going to die anyway, so why not try a new experimental drug which may help them, or if not them, at least help others with the same illness.

Let's attempt to get it straight. AFAIK, these guys were perfectly healthy and enrolled in the tests for the £1,200 (IIRC) because they probably needed the money desperately due to the tax-grabbing socialist whores in power here at the moment bleeding them dry.

Example...
Council (community) tax rate rise: 12-15% per year.
Average wage rise: 2-4% per year.

demograph68 · Mar 16, 2006, 04:24 PM

(btw, it's from Scanners)

I Bent My Wookiee · Mar 16, 2006, 04:26 PM

Originally Posted by Nai no Kami

That movie rules.

I found it rather boring.

Person Man · Mar 16, 2006, 04:39 PM

Originally Posted by Doofy

Let's attempt to get it straight. AFAIK, these guys were perfectly healthy and enrolled in the tests for the £1,200 (IIRC) because they probably needed the money desperately due to the tax-grabbing socialist whores in power here at the moment bleeding them dry.

Example...
Council (community) tax rate rise: 12-15% per year.
Average wage rise: 2-4% per year.

Yes, and as part of the process, the people conducting the test explains that "bad things may happen. We are unable to predict what could happen. You could even die because of these unforseeable bad things. Now, do you still want to participate?"

analogika · Mar 16, 2006, 04:46 PM

Originally Posted by I Bent My Wookiee

I found it rather boring.

We all have our deficits.

Doofy · Mar 16, 2006, 04:47 PM

Originally Posted by Person Man

Yes, and as part of the process, the people conducting the test explains that "bad things may happen. We are unable to predict what could happen. You could even die because of these unforseeable bad things. Now, do you still want to participate?"

Yep.

goMac · Mar 16, 2006, 04:52 PM

Originally Posted by Doofy

Let's attempt to get it straight. AFAIK, these guys were perfectly healthy and enrolled in the tests for the £1,200 (IIRC) because they probably needed the money desperately due to the tax-grabbing socialist whores in power here at the moment bleeding them dry.

Example...
Council (community) tax rate rise: 12-15% per year.
Average wage rise: 2-4% per year.

I blame the liberals for the extinction of dinosaurs and the canceling of the original Battlestar Galactica.

analogika · Mar 16, 2006, 05:00 PM

Originally Posted by goMac

I blame the liberals for the extinction of dinosaurs

And they only did it to make the creationists look like complete idiots.

Doofy · Mar 16, 2006, 05:14 PM

Originally Posted by goMac

I blame the liberals for the extinction of dinosaurs and the canceling of the original Battlestar Galactica.

Chuckit · Mar 16, 2006, 05:25 PM

Originally Posted by goMac

I blame the liberals for the extinction of dinosaurs and the canceling of the original Battlestar Galactica.

Wow, liberals really have done a lot of good in the world.

tooki · Mar 16, 2006, 05:31 PM

Hey, you all, not another peep about politics. This isn't the Political Lounge.

tooki

Albert Pujols · Mar 16, 2006, 05:46 PM

Originally Posted by Doofy

Let's attempt to get it straight. AFAIK, these guys were perfectly healthy and enrolled in the tests for the £1,200 (IIRC) because they probably needed the money desperately due to the tax-grabbing socialist whores in power here at the moment bleeding them dry.

Example...
Council (community) tax rate rise: 12-15% per year.
Average wage rise: 2-4% per year.

That's not bad. I did an 18 month study for this one drug and all I got was this lame certificate.

oh and the realization that I helped kids much like myself.. but that's gay anyway.

tooki · Mar 17, 2006, 10:33 AM

Don't use "gay" as an all-purpose expression of distaste here.

tooki

Anand · Mar 17, 2006, 12:38 PM

Getting back to the trial itself, from the looks of it, I bet it was some contamination in the drug and not the agent itself. That is, the drug is an antibody to CD28 and I would be utterly remarkable if it would cause this sort of toxicity. This looks like a huge dose of LPS or something.