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Forums > Social Discussion > Six Men In Hospital After Drug Trial

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Ry
Ry

Gromit's Humble Squire
Location: Brisbane, Australia
Member Since: 2nd Feb 2005
Total posts: 4496
Posted:http://uk.news.yahoo.com/15032006/140/six-men-hospital-drug-trial.html
br>


Just watched this report on the news. Apparently each of the men were paid $5000 (around 2000 quid?) to be injected with this prototype anti-inflammatory drug.



Watched one of the victim's distressed Australian (probably why it made the news here) girlfriend describe the incident, after being told he was critical and could die. Was pretty hard-hitting.



Should the victim have been prepared for it, or should the pharmaceutical company have taken measures to ensure it didn't get this bad (does that defeat the purpose of clinical trials?)



What say you?


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Asena
Asena

What a Bummer
Location: Shatfield, Hertfordshire
Member Since: 22nd Aug 2005
Total posts: 3224
Posted:Its a shame really... I had a conversation with 2 people who work for Roche yesterday, and we were discussing that this is the first instance this has happened, well, since I know off. Pharmaceitucal companies are more monitored and regulated than space travel. It would be a shame if people stopped volunteering to help medical development. If every successful clinical trial was shown on the news, compared to this one, you'd see how rare this really is... but I fear, that because of this, it will get a bad reputation, and like OWD said, it hit home with him and I guess it willl with many others, who may decide to withdraw from clinical trials. frown

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buzzingtalk
buzzingtalk

Member
Location: London, england
Member Since: 17th Nov 2005
Total posts: 152
Posted:its just something that has to happen i beleive. this incident has only solidified my distaste in animal testing, ive always hated it, and in my opinion its completely wrong. without people like some people in this thread who have offered their services to drug testing, how would we be able to save other people without taking a chance? i think something like this needed to happen (not like they deserved it) in order to remind us that humanity is not perfect, and that medical advances are still happening and in the works. the british media is bombarded with drug adverts claiming to be the cure, to be perfect, yet people still die from cancer every day.
mind you, i am a big sceptic of science in general, mainly becuase im sick of hospitals as a result of being ill from a young age!
i hope this made sense and came across the right way, im not too good at explaining stuff like this!
peace


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Asena
Asena

What a Bummer
Location: Shatfield, Hertfordshire
Member Since: 22nd Aug 2005
Total posts: 3224
Posted:You made sense, but I disagree. No medication is claiming to be a miracle cure, but many have helped increase the life span or quality of life for many patients. There are no drugs to cure cancer itself, but many drugs will help with pain or symptons a patient might experience. Without the animal testing or clinical trials, this drug would have gone straight from in vitro. testing to on the market... and think how many more people it could have affected?

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Tao Star
Tao Star

Pooh-Bah
Location: Bristol
Member Since: 30th May 2003
Total posts: 1662
Posted: Written by: buzzingtalk


its just something that has to happen i beleive. this incident has only solidified my distaste in animal testing, ive always hated it, and in my opinion its completely wrong.



confused confused confused

you'd rather this happened to people than animals?? that sounds messed up to me...sorry! i love animals, and sorry if this sounds harsh, but i love people more, and if we're going to help them then i think it's a necessary evil.

i can't believe that anyone would say they thought this was a good thing.....i can't say more than that really, i neve thought i'd hear a compassionate person say that!

also, i don't believe that this incident was a result of testing on animals not applying to humans....rather a case of very bad planning. obviously i don't know that for certain, but with facts as they're presented that seems to be the case.


I had a dream that my friend had a
strong-bad pop up book,
it was the book of my dreams.

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UCOF
UCOF

Carpal \'Tunnel

Member Since: 17th Apr 2002
Total posts: 15414
Posted:"i can't believe that anyone would say they thought this was a good thing" She didnt say that at all Marf. She said she had always though animal testing was a bad thing. Not that this happening to humans instead of animals was better.

(credit to simian for the following, i would like to say i had thought of it, but we were talking about it last night)
The medical trial is going to have massive implications. Why on earth did the drug not affect animals at all, but affected the human tests so much? What is it that is different and how can we learn from it.
The reaon that this has all turned out the way it has is that something like this has never happened before and so they could not have predicted or prepared for it. Now it has happened, the medical authority will put new counte measures in place.
The example of this was that it was given to 6 people almost simultaenously instead of one. Obvisouly, hindsight is a great thing, but you cant prepare for somethign you totally didnt expect.
I think that a big leap in medicine will be made shortly after this terrible mess.


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Tao Star
Tao Star

Pooh-Bah
Location: Bristol
Member Since: 30th May 2003
Total posts: 1662
Posted:not at all....lots of reports i've read in various papers say there's confusion about how thorough the aniumal testing was, and also that they took a lot less time ( can't remember the exact length, but it was fairly shocking) testing the drug than usual. it seems that it was really really bad planning, not a surprise that no one could have avoided.

from my understanding they COULD have prepared for it in a much bigger way than they did and potentially avoided this.

feel free to prove me wrong, all i'm going on is my impressions from the news, i guess it'll all come out when they investigate properly, but it doesn't seem to have anything to do with animal testing being unreliable to me, and i guess the fact that this is so rare kind of backs that up.

confused confused confused confused confused


I had a dream that my friend had a
strong-bad pop up book,
it was the book of my dreams.

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Birgit
Birgit

had her carpal tunnel surgery already thanks v much
Location: Edinburgh
Member Since: 27th Jan 2005
Total posts: 4145
Posted:science and the media...

we're currently experiencing a mix of
- a company at the same time trying to find out what happened, and informing the public due to the massive interest, while possibly minimising the damage this does to them
- the media being actually quite decent for not blowing this up too much for a change (though headlines like "my boyfriend looks like the elephant man" certainly don't help), while trying to give the public new information about twice a day and therefore mentioning every detail like there MAY have been this or that
- the public trying to understand what's happened and how this is affecting their lives (potentially) and having to rely on what the media are told

This is always a dangerous mix, and it will take ages to figure out what's wrong. By that time, a lot of people will probably have formed their opinion already...

buzzingtalk, if the media are full of stuff about wonder cures, this is MOSTLY because of 2 things:
1. idiots - people who sell vitamin preparations and wonder cures for incredible amounts of money (you'd find that in the ads sections though)
2. the media trying to make headlines or trying to get their articles printed by exaggeration, or scientists not checking their quotes before they get published. See Doc Lightning's "the cure for cancer" thread. A professor where I used to work gave an interview about "a substance we discovered that seems to be involved in the development of cancer". Next day he had dozens of people standing outside his office and abusing him for not giving him the cancer cure he had discovered...

I'm ill since I was little, too, and guess what? Without science, animal experiments and trials I'd be dead. So it's not science I distrust, but what some make of it fpr sake of their profits.


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buzzingtalk
buzzingtalk

Member
Location: London, england
Member Since: 17th Nov 2005
Total posts: 152
Posted:i comfused people :s
i think this is a really effed up scenario no one deserves this, bloody hell im not a psycho! i just think that this just goes to show that animal testing isnt always right. becuase the drugs reacted with the humans and not the animals. its not really an argument, its just my opniion anyways and i know i will never win on the animal testing thing but i thought id drop it in. i think its crap how humans probably did so many negative tests on these animals just to have this disaster happen. im just saying that i think it is wrong humans always come before everything else, like we trash everything like our planet (not all of us but humans in general) kill everything and cause a neucense. this is the point of view i come from!

sorry if it came vout wrong :s


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Asena
Asena

What a Bummer
Location: Shatfield, Hertfordshire
Member Since: 22nd Aug 2005
Total posts: 3224
Posted:Buzzingtalk, I understand what you are saying, and I agree that we do more damage than good in some scenarios, but I feel, in the case of drug development, it is a necessary step that we need to take. Dont forget, animals also benefit from medicines. Everytime people take their pets to the vets, or animals need to be immunised, they are getting the benefits of the research. Its not just humans who benefit from drugs. I disagree on animal testing for beauty products, as it seems a waste of life just so we can look nicer.

I know animal testing isnt nice, and I suppose the harshest thing is we give the animals the disease or illness so we can test medicine on them to see if it works, but i feel it is for the greater good.


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Motley
Motley

addict
Location: UK
Member Since: 9th Oct 2005
Total posts: 434
Posted: Written by: Tao Star


 Written by: onewheeldave


Not at all, I don't see it as relevant; after all, this drug had gone through all the previous tests including computer simulations and animal testing; yet still was deadly on being given to humans.






haven't read whole post...sorry, but just thought i'd add this...

i've heard different reports from lots of sources, and eveyone seems to be quite confusled, but i read in the evening standard yesterday that they originally claimed to have tested the drug on, among other animls, a dog, which subsiquently died. then when confronted about it they denied it (bearing in ming the the drugs company only employs 15 people, also according o the evening standard, surely it would be hard to confuse this?).

i don't know if it is or isn't true, other papers have, and have't mentioned the dog. but if it is true, why would you test somethin on humans which killed a dog? seems like a bad premise to me.

i dunno who is in the right or wrong, but whatever, it seems like they didin't do their reseach properly. it's not like this kind of thing os commonplace. people who go in for drugs trials should maybe be prepared for possible illnes, but not potential death. if you don't know if somethng might make people this ill and cause organ faliure, i don't care what anyone says, you shouldn't give it to people.

 Written by: UCOF


'Written by: Jeff
The common cold is impossible to prevent using current technology due the the high rate of evolution in the viruses responible.'



Does that mean that creationists can cure the common cold?



yes. they just pray for a miricle. that's why no christians get colds...haven't you noticed?



Firstly I'd like to point out that animals in tox studies dying is not uncommon. Animals are just as likely to die in the lab as they are anywhere else. This is particularly the case with carcinogenicity studies which are conducted over the length of the natural life of the animal (usually ~ 2 years in rats) where you often see multiple natural deaths and tumours which are simply down to natural causes. The important thing is not if they die, but WHY they die. If you can demonstrate that the cause of death was not treatment related then you can reasonably conclude that the drug is safe in that appliacation (species/strain/dose/length of study etc)(very simplified example, of course to determine that a drug is safe requires a large portfolio consisting of multiple tests, and as we have seen this is not infallible).

Secondly to suggest they didnt do their research properly is probably a bit harsh since we dont actually know what happened yet. They may well have all the backup data to suggest the drug is safe (this has to be assessed before you can perform a clinical trial in humans anyway so the MHRA are jsut as to blame as the company if the data is inadequate/badly interpreted).

Finally a comment aimed at no one in particular. Be careful not to take everything you read/watch on the tv as gospel. At this stage no one knows what happened, or why, or where the fault lies (if anywhere) and a lot of what is presented as news is often very skewed, speculative or plain wrong. Personally I'd love to get my hands on this drugs portfolio so I could interpret the data for myself, but thats not going to happen frown

Motley


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buzzingtalk
buzzingtalk

Member
Location: London, england
Member Since: 17th Nov 2005
Total posts: 152
Posted:true but still...i dunno what it is abotu animal testing, i just dont think humans should come before animals i dont think we should put our greif on them. but this is my view and very rarely someone agrees which i dont mind : )

and as for the cost of drug trials - i would happily sit somewhere for a week for a grand, my mum just about earns that in a month of hard 5 day a week labour. id take in some good books, some revision, my guitar, and just chill out. i only just noticed the whole drug testing thing, and am pretty tempted to do it myself! although im not in good health so they probably wont have me :s

and the media is always full of crap thats what it is there for, to stir and distort things. very rarely do i buy a paper or watch the news (i dont have a tv) but when i do there is always a different story on each channel. i have chosen not to beleive anything the media is reporting about this drugs trial thing until i see an interview with each person, speaking about the ordeal.


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onewheeldave
Carpal \'Tunnel
Location: sheffield
Member Since: 28th Aug 2002
Total posts: 3252
Posted:Here's a link to the thread on the rights/wrongs of animal testing.

http://www.homeofpoi.com/ubbthreads/showflat.php/Cat/0/Number/366381
br>
I've just bumped it up as it would be a shame if this thread got taken off-topic by turning into another debate on animal testing.


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But you can make the Bastard work for it."

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Ry
Ry

Gromit's Humble Squire
Location: Brisbane, Australia
Member Since: 2nd Feb 2005
Total posts: 4496
Posted: Written by: Asena



Buzzingtalk, I understand what you are saying, and I agree that we do more damage than good in some scenarios, but I feel, in the case of drug development, it is a necessary step that we need to take. Dont forget, animals also benefit from medicines. Everytime people take their pets to the vets, or animals need to be immunised, they are getting the benefits of the research. Its not just humans who benefit from drugs. I disagree on animal testing for beauty products, as it seems a waste of life just so we can look nicer.



I know animal testing isnt nice, and I suppose the harshest thing is we give the animals the disease or illness so we can test medicine on them to see if it works, but i feel it is for the greater good.





I'm very sympathetic towards animals in general, but I tend to agree with you there Asena. I suppose you have to draw a line somewhere, and compare the benefits/drawbacks and adjust accordingly.



Like a person who 'shoos' mosquitoes away instead of slapping them wouldn't really have too much to say if he/she got dengue fever, malaria, ross river etc. There comes a point your own survival takes priority.


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Asena
Asena

What a Bummer
Location: Shatfield, Hertfordshire
Member Since: 22nd Aug 2005
Total posts: 3224
Posted: Written by: UraniumChipOxidationFacility


I think that a big leap in medicine will be made shortly after this terrible mess.



I'm not so sure. After one of my lectures today, I feel some changes will occur, not for the better or worse, but because of they fact that drugs are getting so complex these days.

Today, in my immunology lecture, the recent clinical trial problems was brought into discussion, seeing as the drug was synthesized anti-bodies. Our lecturer explained the exact mechanism of the monoclonal anti-bodies or "super anti-bodies" as described by the company, however, we now know they are far from super. He explained how the target binding site was CD28, present on every single T-helper cell in the body. When these cells activate, they start the immunological response, pouring out cytokines and signals to reach every cell involved in the immune system.

 Written by: UraniumChipOxidationFacility


Why on earth did the drug not affect animals at all, but affected the human tests so much?



This was also explained to us. Certain drugs will have the same effect in different species, as a lot of species share the same molecular biology (local anaesthetics blocking sodium channels (present on many animal cells)). However, the specificity in the immune system is so extreme, that you have anti-bodies, which will only react to one type of bacteria, or virus. And consider the fact that there are millions of targets for these anti-bodies, thats a lot of different cells.

The point I am trying to make... FINALLY... is anti-bodies are species specific, and it could have been (as suggested by our lecturer) a big an error as the reason the animals werent affected in the same way, is that the Monoclonal anti-bodies used in the drug were specifically targetted for CD28 in HUMANS, and therefore, would not bind to other animal CD28 sites and therefore, no reaction would have happened. This is the extreme basics of immunology, so I hope it wasnt the case. But as our lecturer pointed out, this seems the most likely reason with the current knowledge.

I suppose the point I am trying to make, is that with this level of specificity, will there be point in testing animals in this area of drug development? And how do we test drugs so specific that they need to be tested on humans, without endangering life, or breaking medical ethics (cloning etc.).

Wow... short essay there.


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buzzingtalk
buzzingtalk

Member
Location: London, england
Member Since: 17th Nov 2005
Total posts: 152
Posted:after what happened, will people now question weither animal testing is so safe? after the animal trials were OK but it went wrong on humans? mayb when the people OK the truth will come out and more explanation will be given...

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Motley
Motley

addict
Location: UK
Member Since: 9th Oct 2005
Total posts: 434
Posted: Written by: Asena


 Written by: UraniumChipOxidationFacility


I think that a big leap in medicine will be made shortly after this terrible mess.



I'm not so sure. After one of my lectures today, I feel some changes will occur, not for the better or worse, but because of they fact that drugs are getting so complex these days.

Today, in my immunology lecture, the recent clinical trial problems was brought into discussion, seeing as the drug was synthesized anti-bodies. Our lecturer explained the exact mechanism of the monoclonal anti-bodies or "super anti-bodies" as described by the company, however, we now know they are far from super. He explained how the target binding site was CD28, present on every single T-helper cell in the body. When these cells activate, they start the immunological response, pouring out cytokines and signals to reach every cell involved in the immune system.

 Written by: UraniumChipOxidationFacility


Why on earth did the drug not affect animals at all, but affected the human tests so much?



This was also explained to us. Certain drugs will have the same effect in different species, as a lot of species share the same molecular biology (local anaesthetics blocking sodium channels (present on many animal cells)). However, the specificity in the immune system is so extreme, that you have anti-bodies, which will only react to one type of bacteria, or virus. And consider the fact that there are millions of targets for these anti-bodies, thats a lot of different cells.

The point I am trying to make... FINALLY... is anti-bodies are species specific, and it could have been (as suggested by our lecturer) a big an error as the reason the animals werent affected in the same way, is that the Monoclonal anti-bodies used in the drug were specifically targetted for CD28 in HUMANS, and therefore, would not bind to other animal CD28 sites and therefore, no reaction would have happened. This is the extreme basics of immunology, so I hope it wasnt the case. But as our lecturer pointed out, this seems the most likely reason with the current knowledge.

I suppose the point I am trying to make, is that with this level of specificity, will there be point in testing animals in this area of drug development? And how do we test drugs so specific that they need to be tested on humans, without endangering life, or breaking medical ethics (cloning etc.).

Wow... short essay there.



Not a bad explaination Asena, I think I'd have stuggled to explain it in as few words as that. Actually I was discussing this at work today. We came to the comclusion that with that many people working on the problem there is no way they could have missed such a fundamental issue (or is there? would throw up a lot of questions about scientists becoming so overwhelmed with the intricacies of things and missing the basics as a result, but no good scientist should allow that to happen, anyway I digress), its not like use of monoclonal antibodies for therapeutics is a new field. Theres whole companies dedicated to just that avenue of research. Theoretically you could use transgenics expressing the human CD28 gene to cover this off in a tox study, although this becomes very complex from an interpretation point of view.

Motley


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say_cheese
say_cheese

Brown
Location: Behind You!
Member Since: 6th Nov 2005
Total posts: 288
Posted:"cells activate, they start the immunological response, pouring out cytokines and signals to reach every cell involved in the immune system."



Just to add a few thing to your point matt,

- These "super antibodies" are very specific as you have said and this makes them lethal as we have seen, the antibodies in the trail were specific to EVERY single T-Cell in the six guys.

- T- Cells are part of the primary specific immune response, so activting EVERY T-Cell in the human body caused a HUGH immune respnose, causing massive amounts of imflmation and the added toxins released from T-Cytotoxic cells (The toxins released contain molecules similar to those found in house hold bleech!)



"Why on earth did the drug not affect animals at all, but affected the human tests so much? "



- Antibodys are very specific to antigens, there are probably millions of possible antigens, as matt said even if the drug was tested on animals, there so much variation in the antibody binding sites that they animals tested on may not have had those spesific binding sites.



good work there matt, i see you have done your research!

*pats matts head*



wink



Just to comment on your point Motley



- there is the matter that these scientists may have missed the basic principles of immunology but this is very far fetched as there is no way that monoclonal antibodies complementary to the specific MHC receptors could have been put together in the lab with out a basic knowledge of the immune system.



- Also just a note on using transgenic organisms in the study of immunological function, Antibodies are highy specific as we now know. There are over 300 genes that control just one of the hyper varible sites on an antibody. therefore it would probably not be in the intrests of big compaines to go to all that trouble, they would rather use samller but scaleable tests.



Anyway i gues what my point is that testing on humans and other animals is the only way to examin the effects of the new drugs on biological systems. the fact that there are six peeps in hospital because of them trying a new drug is bad but this was expected to happen sooner or later and im sure that there are many other drug trails that dont go as expected but we just never get to hear about them as the drug companies like to keep it quite so not to damage there rep and the media have "better things" (like whos had plastic surgery) to tell us about.



ok i think im dont ranting ......... rolleyes

EDITED_BY: say_cheese (1142989219)


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FireTom
Stargazer

Member Since: 20th Sep 2003
Total posts: 6650
Posted:Is that were human clones would be appropriate testing candidates? *just to make another bad joke... don't hit me, please*

 Written by: NYC

There are two extremes in getting a drug ready for market, testing too fast and not testing fast enough.

Rushing a drug to market might result in situations like this.

Keeping a drug from the public for too many tests will result in people dying because of the lack of access to new medications.

The happy medium is NOT when nobody dies, but when the damage of moving forward is offset by the damage by not moving forward.




I'm likely to agree with you NYC, hence I think it's better to wait longer rather than to provide deadly aid. IMHO there is nothing worse than killing someone with a drug that is supposed to cure, just because there was not enough time to test it thoroughly...


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Birgit
Birgit

had her carpal tunnel surgery already thanks v much
Location: Edinburgh
Member Since: 27th Jan 2005
Total posts: 4145
Posted: Written by: Asena


it could have been (as suggested by our lecturer) a big an error as the reason the animals werent affected in the same way, is that the Monoclonal anti-bodies used in the drug were specifically targetted for CD28 in HUMANS, and therefore, would not bind to other animal CD28 sites.




D'oh. I really hope that's not the reason. Though I have to admit it makes a very good explanation. But it IS a fundamental thing, designing a specific antibody and testing it on something just as specific...

But then, that Mars-exploring-robot-thing crashed on the planet because someone got inches and centimetres mixed up...

Asena, why would anyone WANT to activate T cells in things like MS and arthritis? Wouldn't they make things worse? (sorry, am a bit crap with immunology'n all that)


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Motley
Motley

addict
Location: UK
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Total posts: 434
Posted: Written by: say_cheese



Just to comment on your point Motley



- there is the matter that these scientists may have missed the basic principles of immunology but this is very far fetched as there is no way that monoclonal antibodies complementary to the specific MHC receptors could have been put together in the lab with out a basic knowledge of the immune system.





Didnt I say that this was unlikely? In fact that was the very crux of what I was saying.



 Written by: say_cheese



- Also just a note on using transgenic organisms in the study of immunological function, Antibodies are highy specific as we now know. There are over 300 genes that control just one of the hyper varible sites on an antibody. therefore it would probably not be in the intrests of big compaines to go to all that trouble, they would rather use samller but scaleable tests.





Immunology is not my strongest subject but I do know that in the world of neurology/neuropharmacology the development of good transgenic models is helping to reduce the numbers of animals used which is a very important part of fulfilling the 3Rs (Reduction, refinement and replacement of animal tests for those who dont know)



Motley

EDITED_BY: Motley (1143054183)


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say_cheese
say_cheese

Brown
Location: Behind You!
Member Since: 6th Nov 2005
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Posted:ah yes i see now...i got the wronge end of the antibody *he he*, i do agree that no scientist would make silly mistakes, and if they did there peirs would see it befor they went ahead with any trails anyway.

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Asena
Asena

What a Bummer
Location: Shatfield, Hertfordshire
Member Since: 22nd Aug 2005
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Posted: Written by: say_cheese



ah yes i see now...i got the wronge end of the antibody *he he*, i do agree that no scientist would make silly mistakes





but.....



 Written by: Birgit

But then, that Mars-exploring-robot-thing crashed on the planet because someone got inches and centimetres mixed up...





rolleyes



EDIT: Sorry Birgit, I dont know the answer to your question. Its something I've been looking into, but have had to much work on at the mo. Stay tuned, may have an answer with in a few days. smile

EDITED_BY: Asena (1143154289)


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Birgit
Birgit

had her carpal tunnel surgery already thanks v much
Location: Edinburgh
Member Since: 27th Jan 2005
Total posts: 4145
Posted:Just an update... I just read that one of the guys who was released from hospital and told he'd be alright has lymphatic cancer now frown He's also been told to expect a range of autoimmune diseases.

Apparently they've all been paid 10,000 pounds but want to sue for 5 millions each.


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Ry
Ry

Gromit's Humble Squire
Location: Brisbane, Australia
Member Since: 2nd Feb 2005
Total posts: 4496
Posted:That's a really shoddy portion of luck.. I don't know how they'd go about building their case though. As heartless as it may sound, it was what they were signing up for..

I think I'll be thinking this one out for a while.

http://uk.news.yahoo.com/06082006/323/victim-drugs-trial-britain-shows-signs-cancer.html


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Doc Lightning
Doc Lightning

HOP Mad Doctor
Location: San Francisco, CA, USA
Member Since: 28th May 2001
Total posts: 13920
Posted:People go on about how "we should experiment on people!" This is why it's the last step and why these situations are so rare.

-Mike )'(
Certified Mad Doctor and HoP High Priest of Nutella

"A buckuht 'n a hooze!" -Valura

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Birgit
Birgit

had her carpal tunnel surgery already thanks v much
Location: Edinburgh
Member Since: 27th Jan 2005
Total posts: 4145
Posted:Thanks for the link, Ry!

I think they may have a chance to get a higher compensation because there are indications that the previous testing was a bit dodgy (reading back on some of the things Asena posted). However the company's already claimed insolvence, so where they'd get 30 million pounds from I don't know.

At least people seem to have learned from it and suggested some improvements on the clinical trials, including:

- testing on only 1 person at a time (quite sensible I think)

- lowering the initial dose (not too sure about that - cause if the initial dose is way too low they'll eventually make it higher again and get similar results... I think that only helps in very rare cases)

- initial testing on sick people instead of on healthy ones (again, not too sure about it, but then it's the sick people who need the new medicine so it seems fair enough)


"vices are like genitals - most are ugly to behold, and yet we find that our own are dear to us."
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Doc Lightning
Doc Lightning

HOP Mad Doctor
Location: San Francisco, CA, USA
Member Since: 28th May 2001
Total posts: 13920
Posted: Written by: Birgit


Thanks for the link, Ry!

- testing on only 1 person at a time (quite sensible I think)


Would make it just take longer to get a drug to market.
 Written by:


- lowering the initial dose (not too sure about that - cause if the initial dose is way too low they'll eventually make it higher again and get similar results... I think that only helps in very rare cases)


How low? How do you know?
 Written by:


- initial testing on sick people instead of on healthy ones (again, not too sure about it, but then it's the sick people who need the new medicine so it seems fair enough)



You need to start with healthy people because sick people are already on lots of medication and you don't know if an adverse event is an interaction or not.


-Mike )'(
Certified Mad Doctor and HoP High Priest of Nutella

"A buckuht 'n a hooze!" -Valura

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Birgit
Birgit

had her carpal tunnel surgery already thanks v much
Location: Edinburgh
Member Since: 27th Jan 2005
Total posts: 4145
Posted: Written by: Doc Lightning


 Written by: Birgit


- testing on only 1 person at a time (quite sensible I think)


Would make it just take longer to get a drug to market.



Oh, I suppose what they want to do is what's already done in other countries and test one by one, not with weeks or anything in between, but not dosing 8 people within less than half an hour as they did there. I mean, if they'd left as little an hour 5 people could've been spared that extreme reaction.


 Written by: Doc Lightning


 Written by: Birgit


- lowering the initial dose (not too sure about that - cause if the initial dose is way too low they'll eventually make it higher again and get similar results... I think that only helps in very rare cases)


How low? How do you know?




Read it on a German newspage, otherwise I'd link to it... I don't know exactly how low, apparently there's been some committee or other working out how disasters like this can be avoided and it was one of the things they've put through as a suggestion. From a toxicology point of view, since the first tests are on a very low dose anyways, I doubt it would be more than another factor five or ten that you could go down to, but that's just a guess.

 Written by: Doc Lightning

 Written by: Birgit


- initial testing on sick people instead of on healthy ones (again, not too sure about it, but then it's the sick people who need the new medicine so it seems fair enough)



You need to start with healthy people because sick people are already on lots of medication and you don't know if an adverse event is an interaction or not.



Yeah, that's why I said I'm not too sure. I guess there are few cases where there is only one type (or no type) of medication so that possible interactions would have to be accepted...

Speaking from the point of view of one of the researchers at my old institute though, current legislation (at least in Germany) makes it very hard to follow up some potentially good ideas. They were working on immunotherapy for some forms of cancer, but not allowed to test on sick subjects, with the exception of the terminal cases. Now of course something that might work in the early stages of cancer won't save someone who is already full of metastases with quite possible further mutations. They weren't even allowed to test on those patients who were eager to volunteer... well, I guess it's different from case to case if testing on sick people makes sense!


"vices are like genitals - most are ugly to behold, and yet we find that our own are dear to us."
(G.W. Dahlquist)

Owner of Dragosani's left half

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Asena
Asena

What a Bummer
Location: Shatfield, Hertfordshire
Member Since: 22nd Aug 2005
Total posts: 3224
Posted: Written by: Doc Lightning


You need to start with healthy people because sick people are already on lots of medication and you don't know if an adverse event is an interaction or not.



From what I've learnt in my new jobs, many drugs miss this part. Phase I clinical trials arent applicable to all medicines, as although you get an Idea of the side effects, its not wise to give healthy patients varieties of chemo-therapies for cancer treatment...

Has anyone heard the latest on why it affected Humans so badly? Its due to something called a cytokine storm, a biological process not present in the monkeys the drug was initially tested on.

I would also like to see thier protocols (thought I doubt I could get anywhere near them frown ). As ICHGCP advises delayed infusion times, and ICHGCP is what ALL Pharmaceutical companies are bound too. If anyone wants more info on Good clinical practice in drug trials let me know smile.


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Doc Lightning
Doc Lightning

HOP Mad Doctor
Location: San Francisco, CA, USA
Member Since: 28th May 2001
Total posts: 13920
Posted:See, the fact that this happened doesn't mean the system is broken. It means it's not perfect. And it will never be. You can't go rearranging the way everything is done every time a freak accident occurs.

This is tragic, but it's not a reason to halt all medical research.


-Mike )'(
Certified Mad Doctor and HoP High Priest of Nutella

"A buckuht 'n a hooze!" -Valura

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