Forums > Social Discussion > Six Men In Hospital After Drug Trial
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Gromit's Humble Squire
4,496 posts
Location: Brisbane, Australia
Gromit's Humble Squire
4,496 posts
Location: Brisbane, Australia
Posted:
https://uk.news.yahoo.com/15032006/140/six-men-hospital-drug-trial.html
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?
https://uk.news.yahoo.com/15032006/140/six-men-hospital-drug-trial.html
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?
GOLD Member
Gromit's Humble Squire
4,496 posts
Location: Brisbane, Australia
Gromit's Humble Squire
4,496 posts
Location: Brisbane, Australia
Posted:
Asena: Well, they've got deep pockets while there are a lot of people out there with empty pockets..
Asena: Well, they've got deep pockets while there are a lot of people out there with empty pockets..
SILVER Member
Carpal \'Tunnel
2,666 posts
Location: Preston, United Kingdom
Carpal \'Tunnel
2,666 posts
Location: Preston, United Kingdom
Posted:
I caught a few seconds of the news this afternoon. It turns out the candidates where given only one/500th the ammount that was safely given to animals...or one/200th...well it was in the hundreths. Now if I had been involve din the trails and someone told me I was only getting that amount I wouldnt have any second thoughts on the matter
I caught a few seconds of the news this afternoon. It turns out the candidates where given only one/500th the ammount that was safely given to animals...or one/200th...well it was in the hundreths. Now if I had been involve din the trails and someone told me I was only getting that amount I wouldnt have any second thoughts on the matter
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'Time goes by so slowly for those who wait...' - Whatever Happend To Baby Madonna?
enthusiast
255 posts
Location: Melbourne - home of pirates
255 posts
Location: Melbourne - home of pirates
Posted:
At the end of the day we don't know exactly what went wrong. These tests have inherent risks. As much as we want to believe that they are risk free, and kid ourselves that similar disasters haven't happened in living memory, THERE IS A REASON WHY PEOPLE GET PAID SO MUCH TO TAKE THESE DRUGS.
Unfortunately for these men, this risk was real. I believe in the current process.
At the end of the day we don't know exactly what went wrong. These tests have inherent risks. As much as we want to believe that they are risk free, and kid ourselves that similar disasters haven't happened in living memory, THERE IS A REASON WHY PEOPLE GET PAID SO MUCH TO TAKE THESE DRUGS.
Unfortunately for these men, this risk was real. I believe in the current process.
"You've gone from Loey the Wonder Lesbian to everyone wondering if you are a lesbian." - Shadowman
Yesterday is yesterday. If we try to recapture it, we will only lose tomorrow.
GOLD Member
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Posted:
People don't necessarily have to die for it to be 'deadly' though.
Written by: UraniumChipOxidationFacilityWritten by: OWD
yet still was deadly on being given to humans
Please correct me if im wrong, but I dont think anyone has died from it yet.Written by: https://news.bbc.co.uk/1/hi/health/4813478.stm
class="endsmall">
Two remain critically ill but four have shown signs of improvement.
People don't necessarily have to die for it to be 'deadly' though.
"You can't outrun Death forever.
But you can make the Bastard work for it."
--MAJOR KORGO KORGAR,
"Last of The Lancers"
AFC 32
Educate your self in the Hazards of Fire Breathing STAY SAFE!
SILVER Member
veteran
1,286 posts
Location: My House, United Kingdom
veteran
1,286 posts
Location: My House, United Kingdom
Posted:
surely "deadly" means causes death, now im an optimist, and no-one has died from it yet.
surely "deadly" means causes death, now im an optimist, and no-one has died from it yet.
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GOLD Member
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Posted:
The money is not that good-
As for the risk, no-one's 'kidding themselves' that similar disasters haven't happened in living memory- as far as I know, this is the first in the UK.
I'm been through the standard screening for these things including being informed of the risk and signing the waivers- throughout it is presented as a pure formality; I suspect many who volunteer for these tests believe the waivers are purely legal formalities in this age of paranoia about corporations being sued.
these tests are presented as being very safe indeed and the risks focused on tends to be minor ones.
Written by: wonderloey
At the end of the day we don't know exactly what went wrong. These tests have inherent risks. As much as we want to believe that they are risk free, and kid ourselves that similar disasters haven't happened in living memory, THERE IS A REASON WHY PEOPLE GET PAID SO MUCH TO TAKE THESE DRUGS.
The money is not that good-
Written by: onewheeldave
Lastly, I would say that the money isn't necesarily as good as it sounds- £1000 pounds for a weeks stay sounds amazing, but bear in mind that you're in 24/7, no going outside, no tea/coffee (hence guaranteed 'caffiene headaches' for those who drink regualr tea/coffee') no choice in what you're going to eat for those seven days etc.
Divide £1000 by the number of hours you're actually 'working' for, and it comes out to £5.95/hr.
As for the risk, no-one's 'kidding themselves' that similar disasters haven't happened in living memory- as far as I know, this is the first in the UK.
I'm been through the standard screening for these things including being informed of the risk and signing the waivers- throughout it is presented as a pure formality; I suspect many who volunteer for these tests believe the waivers are purely legal formalities in this age of paranoia about corporations being sued.
these tests are presented as being very safe indeed and the risks focused on tends to be minor ones.
"You can't outrun Death forever.
But you can make the Bastard work for it."
--MAJOR KORGO KORGAR,
"Last of The Lancers"
AFC 32
Educate your self in the Hazards of Fire Breathing STAY SAFE!
GOLD Member
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Posted:
As far as I'm concerned, everday use of the word 'deadly' includes the meaning 'very bad indeed' and includes the situation of being given a drug which causes multiple failure of essential organs and the need for life support.
However, if you want to take it to the dictionary, mine says that 'deadly' means 'likely to cause death' which is compatible with the victims actually surviving.
Written by: Vampyricacid
surely "deadly" means causes death, now im an optimist, and no-one has died from it yet.
As far as I'm concerned, everday use of the word 'deadly' includes the meaning 'very bad indeed' and includes the situation of being given a drug which causes multiple failure of essential organs and the need for life support.
However, if you want to take it to the dictionary, mine says that 'deadly' means 'likely to cause death' which is compatible with the victims actually surviving.
"You can't outrun Death forever.
But you can make the Bastard work for it."
--MAJOR KORGO KORGAR,
"Last of The Lancers"
AFC 32
Educate your self in the Hazards of Fire Breathing STAY SAFE!
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Momma Bear
4,525 posts
Location: Telford, Shrops, United Kingdom
Momma Bear
4,525 posts
Location: Telford, Shrops, United Kingdom
Posted:
the dude on the news said that the drug was mimicking the T cells. And the T cells must have gone crazy and started attacking the "normal" cells. Scary as hell.
the dude on the news said that the drug was mimicking the T cells. And the T cells must have gone crazy and started attacking the "normal" cells. Scary as hell.
Hoppers are angels who lift us to our feet when our wings have trouble remembering how to fly.
BRONZE Member
old hand
1,107 posts
Location: In a test pit, Mackay, Australia
old hand
1,107 posts
Location: In a test pit, Mackay, Australia
Posted:
As a bit of an aside, pharmaceutical companies acknowledge that there are risks in all drugs after they hit the market, it's why the pharmaceuatical handbook has those yellow pages in the back so people can report any bad effects they encounter, but others can only be warned if the appropriate body is informed.
So, if you have a bad reaction, tell your doctor so they can send off the form, you may save others from harm by doing so.
As a bit of an aside, pharmaceutical companies acknowledge that there are risks in all drugs after they hit the market, it's why the pharmaceuatical handbook has those yellow pages in the back so people can report any bad effects they encounter, but others can only be warned if the appropriate body is informed.
So, if you have a bad reaction, tell your doctor so they can send off the form, you may save others from harm by doing so.
There is a slight possibility that I am not actually right all of the time.
BRONZE Member
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
Posted:
Happens a lot, though usually in one tissue at a time... it nearly killed me when I was 2, and anyone with an autoimmune disorder can tell you a story about this. If you've got one autoimmune disorder, you're more likely to get a 2nd one than people who don't have any are to develop any at all. But it happening to lots of organs at once, and at that speed, is extraordinary. Much as I feel for the people in the trial, I'd love to learn the mechanisms behind that.
*NOT animal-experiment-discussion, but rather what-would-be-if-trials-started-with humans-discussion*
Dave, what I think is that if all trials started on humans, you'd be very hard-pressed to find volunteers any more, which means that the chances of finding cures for illnesses would go towards 0. Also, imagine how much of these cases are avoided by the use of non-human models before human ones. And the fact that, if the dose hadn't been determined in animals first, it might've been much higher and all 6 people would be dead by now.
and
for British standards for testing more than one person at a time as a general policy!
Written by: jo_rhymes
the T cells must have gone crazy and started attacking the "normal" cells. Scary as hell.
Happens a lot, though usually in one tissue at a time... it nearly killed me when I was 2, and anyone with an autoimmune disorder can tell you a story about this. If you've got one autoimmune disorder, you're more likely to get a 2nd one than people who don't have any are to develop any at all. But it happening to lots of organs at once, and at that speed, is extraordinary. Much as I feel for the people in the trial, I'd love to learn the mechanisms behind that.
*NOT animal-experiment-discussion, but rather what-would-be-if-trials-started-with humans-discussion*
Dave, what I think is that if all trials started on humans, you'd be very hard-pressed to find volunteers any more, which means that the chances of finding cures for illnesses would go towards 0. Also, imagine how much of these cases are avoided by the use of non-human models before human ones. And the fact that, if the dose hadn't been determined in animals first, it might've been much higher and all 6 people would be dead by now.
and
for British standards for testing more than one person at a time as a general policy! "vices are like genitals - most are ugly to behold, and yet we find that our own are dear to us."
(G.W. Dahlquist)
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HOP Mad Doctor
13,925 posts
Location: San Francisco, CA, USA
HOP Mad Doctor
13,925 posts
Location: San Francisco, CA, USA
Posted:
You can't stop medical research or change the way it's done because of one bad experience.
More restrictions and more limits will only slow progress.
As someone who has benefited GREATLY from a recent drug development, we have to forge on.
You can't stop medical research or change the way it's done because of one bad experience.
More restrictions and more limits will only slow progress.
As someone who has benefited GREATLY from a recent drug development, we have to forge on.
-Mike
Certified Mad Doctor and HoP High Priest of Nutella
A buckuht n a hooze! -Valura
GOLD Member
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Posted:
I think we can certainly change the way its done if the coming investigation turns up ways that this could have been prevented.
Possibly an obvious change will be to disallow the giving of a drug never tested before on humans to several humans at once- as previously mentioned, this would have lead to one ruined life rather than six.
Not only would adapting accordingly be good practice, it may also help research by minimising a likely reduction in future numbers of volunteers.
I think a lot of people who've previously seen these studies as a safe and easy way to make money, are going to be putting a lot more thought into the potential risks and it could well become harder to find people willing to do these studies.
I think we can certainly change the way its done if the coming investigation turns up ways that this could have been prevented.
Possibly an obvious change will be to disallow the giving of a drug never tested before on humans to several humans at once- as previously mentioned, this would have lead to one ruined life rather than six.
Not only would adapting accordingly be good practice, it may also help research by minimising a likely reduction in future numbers of volunteers.
I think a lot of people who've previously seen these studies as a safe and easy way to make money, are going to be putting a lot more thought into the potential risks and it could well become harder to find people willing to do these studies.
"You can't outrun Death forever.
But you can make the Bastard work for it."
--MAJOR KORGO KORGAR,
"Last of The Lancers"
AFC 32
Educate your self in the Hazards of Fire Breathing STAY SAFE!
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HOP Mad Doctor
13,925 posts
Location: San Francisco, CA, USA
HOP Mad Doctor
13,925 posts
Location: San Francisco, CA, USA
Posted:
Here's why that won't work:
Anyone can have an anaphylactic (severe allergic) to a given drug. For some drugs (i.e. the penicillins) this is not terribly uncommon. For other drugs (i.e. the substituted benzimidazoles [proton pump inhibitors]) this is very uncommon.
Suppose you give an experimental drug to a patient and you got unlucky and he happens to anaphylax. You now have a sample size of 1 saying that this drug is amazingly toxic. But in reality you can't know that because you might have a perfectly good drug and a "bad" test subject.
That's why testing new drugs on a single test subject is pointless and unhelpful.
Hundreds of such trials go on every year and this happened once.
This is like trying to stop all air travel every time a plane crashes. You don't re-write the whole system because it's 99.999% good and this one story happened to hit the news.
I'm just amazed that it had no such toxic effects in animal models. That's VERY unusual.
Written by:
Possibly an obvious change will be to disallow the giving of a drug never tested before on humans to several humans at once- as previously mentioned, this would have lead to one ruined life rather than six.
Here's why that won't work:
Anyone can have an anaphylactic (severe allergic) to a given drug. For some drugs (i.e. the penicillins) this is not terribly uncommon. For other drugs (i.e. the substituted benzimidazoles [proton pump inhibitors]) this is very uncommon.
Suppose you give an experimental drug to a patient and you got unlucky and he happens to anaphylax. You now have a sample size of 1 saying that this drug is amazingly toxic. But in reality you can't know that because you might have a perfectly good drug and a "bad" test subject.
That's why testing new drugs on a single test subject is pointless and unhelpful.
Hundreds of such trials go on every year and this happened once.
This is like trying to stop all air travel every time a plane crashes. You don't re-write the whole system because it's 99.999% good and this one story happened to hit the news.
I'm just amazed that it had no such toxic effects in animal models. That's VERY unusual.
-Mike
Certified Mad Doctor and HoP High Priest of Nutella
A buckuht n a hooze! -Valura
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Pooh-Bah
1,848 posts
Location: Adelaide, SA, Australia
Pooh-Bah
1,848 posts
Location: Adelaide, SA, Australia
Posted:
Good point Doc, that hadn't occured to me... i suppose that's why you're a doctor and i'm unemployed
Perhaps it was accidentally contaminated? ...though they probably would have figured that out and told us by now... disregard...
Written by: Doc Lightning
Suppose you give an experimental drug to a patient and you got unlucky and he happens to anaphylax. You now have a sample size of 1 saying that this drug is amazingly toxic. But in reality you can't know that because you might have a perfectly good drug and a "bad" test subject.
Good point Doc, that hadn't occured to me... i suppose that's why you're a doctor and i'm unemployed
Written by: Doc Lightning
I'm just amazed that it had no such toxic effects in animal models. That's VERY unusual.
Perhaps it was accidentally contaminated? ...though they probably would have figured that out and told us by now... disregard...
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BRONZE Member
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
Posted:
I'm sure you can tell an anaphylactic shock from what's happened! It would be one of the things the doctors present would have been completely aware of, and able to treat...
The idea is not to test it on 1 person only, but to start with one, below the No Effects Level predicted, then slightly increase the dose in the next approximately 10 patients. In the case of one getting an anaphylactic shock, the experiment can be repeated with the same dose and a different patient, and people already standing there with the equipment to help if the shock should occur again.
A group of under 20 people which is used for phase 1 trials is not ideal for statistics anyways, but if the first let's say 3 or 4 randomly picked healthy people would suffer an anaphylactic shock at an incredibly low dose that would be quite suspicious...
Anyways, I agree... I'd like to see the animal data.
I'm sure you can tell an anaphylactic shock from what's happened! It would be one of the things the doctors present would have been completely aware of, and able to treat...
The idea is not to test it on 1 person only, but to start with one, below the No Effects Level predicted, then slightly increase the dose in the next approximately 10 patients. In the case of one getting an anaphylactic shock, the experiment can be repeated with the same dose and a different patient, and people already standing there with the equipment to help if the shock should occur again.
A group of under 20 people which is used for phase 1 trials is not ideal for statistics anyways, but if the first let's say 3 or 4 randomly picked healthy people would suffer an anaphylactic shock at an incredibly low dose that would be quite suspicious...
Anyways, I agree... I'd like to see the animal data.
"vices are like genitals - most are ugly to behold, and yet we find that our own are dear to us."
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Owner of Dragosani's left half
SILVER Member
big and good and broken
7,330 posts
Location: lunn dunn, yoo kay, United Kingdom
big and good and broken
7,330 posts
Location: lunn dunn, yoo kay, United Kingdom
Posted:
but that is a seriously large amount to get paid all day, every day, for a week when you have to do nothing and spend nothing whatsoever.
ask someone on minimum wage what they think of getting nearly six pounds an hour, plus food and a bed for doing no work at all - they'll probably ask "what's the catch?".
the answer is "there's a risk to your health as you have to take drugs never used on humans before".
it should be pretty obvious to anyone with even a modicum of sense that pharma trial companies are paying you for the risks you are taking with your health, not for your time.
i can see nothing wrong with presenting the tests as 'very safe' since statistically and qualatatively, they are.
cole. x
Written by: onewheeldave
£1000 pounds for a weeks stay sounds amazing, but bear in mind that you're in 24/7, no going outside, no tea/coffee (hence guaranteed 'caffiene headaches' for those who drink regualr tea/coffee') no choice in what you're going to eat for those seven days etc.
Divide £1000 by the number of hours you're actually 'working' for, and it comes out to £5.95/hr.
but that is a seriously large amount to get paid all day, every day, for a week when you have to do nothing and spend nothing whatsoever.
ask someone on minimum wage what they think of getting nearly six pounds an hour, plus food and a bed for doing no work at all - they'll probably ask "what's the catch?".
the answer is "there's a risk to your health as you have to take drugs never used on humans before".
it should be pretty obvious to anyone with even a modicum of sense that pharma trial companies are paying you for the risks you are taking with your health, not for your time.
i can see nothing wrong with presenting the tests as 'very safe' since statistically and qualatatively, they are.
cole. x
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Pooh-Bah
1,662 posts
Location: Bristol
1,662 posts
Location: Bristol
Posted:
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.
yes. they just pray for a miricle. that's why no christians get colds...haven't you noticed?
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?
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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HOP Mad Doctor
13,925 posts
Location: San Francisco, CA, USA
HOP Mad Doctor
13,925 posts
Location: San Francisco, CA, USA
Posted:
Not with a brand-new drug. With penicillin you know exactly what's happened. With a brand-new drug you have no idea whatsoever.
Written by: Birgit
I'm sure you can tell an anaphylactic shock from what's happened! It would be one of the things the doctors present would have been completely aware of, and able to treat...
Not with a brand-new drug. With penicillin you know exactly what's happened. With a brand-new drug you have no idea whatsoever.
-Mike
Certified Mad Doctor and HoP High Priest of Nutella
A buckuht n a hooze! -Valura
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Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Posted:
A misunderstanding which is probably my fault- I wasn't suggesting testing a drug on a single person, rather I was continuing the ongoing discussion concerning the fact that, in this case, the drug was given to all six volunteers more or less simultaneously.
So, what I'm saying is that when a drug previously not tested on humans is given to a volunteer team, it would make sense to stagger the doses.
In this case, given that the subjects were being rushed to intensive care within an hour of being administered the drug, if the doses had been staggered with, say, 3 hours between the doses (i.e. it's given to the first volunteer, then there's a 3 hour gap before the second recieves it), then there would still have been a tragedy, but it would have affected one individual rather than all six.
Written by: Doc Lightning
Written by: OWD
Possibly an obvious change will be to disallow the giving of a drug never tested before on humans to several humans at once- as previously mentioned, this would have lead to one ruined life rather than six.
Here's why that won't work:
Anyone can have an anaphylactic (severe allergic) to a given drug. For some drugs (i.e. the penicillins) this is not terribly uncommon. For other drugs (i.e. the substituted benzimidazoles [proton pump inhibitors]) this is very uncommon.
Suppose you give an experimental drug to a patient and you got unlucky and he happens to anaphylax. You now have a sample size of 1 saying that this drug is amazingly toxic. But in reality you can't know that because you might have a perfectly good drug and a "bad" test subject.
That's why testing new drugs on a single test subject is pointless and unhelpful.
A misunderstanding which is probably my fault- I wasn't suggesting testing a drug on a single person, rather I was continuing the ongoing discussion concerning the fact that, in this case, the drug was given to all six volunteers more or less simultaneously.
So, what I'm saying is that when a drug previously not tested on humans is given to a volunteer team, it would make sense to stagger the doses.
In this case, given that the subjects were being rushed to intensive care within an hour of being administered the drug, if the doses had been staggered with, say, 3 hours between the doses (i.e. it's given to the first volunteer, then there's a 3 hour gap before the second recieves it), then there would still have been a tragedy, but it would have affected one individual rather than all six.
"You can't outrun Death forever.
But you can make the Bastard work for it."
--MAJOR KORGO KORGAR,
"Last of The Lancers"
AFC 32
Educate your self in the Hazards of Fire Breathing STAY SAFE!
Pooh-Bah
1,662 posts
Location: Bristol
1,662 posts
Location: Bristol
Posted:
apparently that wasn't the case...i read in metro yesterday, and heard in radio 4 in an interview with one of the guys who had the placebo that they were administered at 2 minute intervals and they were progressively given higher doeses. i'm not sure over what period...maybe not 3 hours...but not simulataneous.
apparently that wasn't the case...i read in metro yesterday, and heard in radio 4 in an interview with one of the guys who had the placebo that they were administered at 2 minute intervals and they were progressively given higher doeses. i'm not sure over what period...maybe not 3 hours...but not simulataneous.
I had a dream that my friend had a
strong-bad pop up book,
it was the book of my dreams.
BRONZE Member
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
Posted:
2 minute intervals is about as simultaneous as you can get with 1 person administering... it would've made more sense to do 2 people a day, or 1 a day... but then it's easy for me to talk now we've heard about the results, isn't it?
Doc, I tought anaphylactic shock had quite common symptoms and possible treatments (adrenalin)? I may be wrong though... but if adrenalin works for it then surely it would be one of the things to give to people with any severe reaction and it would probably work?
2 minute intervals is about as simultaneous as you can get with 1 person administering... it would've made more sense to do 2 people a day, or 1 a day... but then it's easy for me to talk now we've heard about the results, isn't it?
Doc, I tought anaphylactic shock had quite common symptoms and possible treatments (adrenalin)? I may be wrong though... but if adrenalin works for it then surely it would be one of the things to give to people with any severe reaction and it would probably work?
"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
NYC
9,232 posts
Location: NYC, NY, USA
9,232 posts
Location: NYC, NY, USA
Posted:
I thought about this a bunch and realized, though the point you bring up is valid (though I personally disagree with but respect the point) the manner in which you initially brought it up was so confrontational it borders on Trolling.
If one is going to bring up an obviously sensitive topic I think it's important to initially lay a foundation and show some sensitivity. It's something I try to do and occationally I'm even successful.
Written by: Patriarch917Written by: jeff(fake)Written by: Patriarch917
Maybe we should add another in between stage where mothers can volunteer their unwanted fetus for medical trials.
I missed this post initially.
This is a sick joke Patriarch. To poke fun at a situation where six men may die and the emotionally sensitive topic of abortion I find unacceptable.
A sick joke? Sick perhaps, but I would hardly call it a joke.
https://www.wnd.com/news/printer-friendly.asp?ARTICLE_ID=22259
https://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=14317
I saw on the news just a few months ago a lady advocating the use of the unborn for medical experimentation. We already do experiments with embryos, and a fetus is just an old embryo.
We must find a way to balance the need to test the drugs on humans, against the desire not to permanently harm or kill the humans. A suggested compromise is to use humans that don’t have a right to life.
I thought about this a bunch and realized, though the point you bring up is valid (though I personally disagree with but respect the point) the manner in which you initially brought it up was so confrontational it borders on Trolling.
If one is going to bring up an obviously sensitive topic I think it's important to initially lay a foundation and show some sensitivity. It's something I try to do and occationally I'm even successful.
Well, shall we go?
Yes, let's go.
[They do not move.]
SILVER Member
big and good and broken
7,330 posts
Location: lunn dunn, yoo kay, United Kingdom
big and good and broken
7,330 posts
Location: lunn dunn, yoo kay, United Kingdom
Posted:
those links are from about 4 years ago patriarch?!
it is a mildly related issue and the statement "Maybe we should add another in between stage where mothers can volunteer their unwanted fetus for medical trials." is a great example of sensationalism alluding to a complex issue.
the last sentence there is a complete misrepresentation and does not relate to the opinion on either side of the debate.
cole. x
Written by: Patriarch917Written by: jeff(fake)Written by: Patriarch917
Maybe we should add another in between stage where mothers can volunteer their unwanted fetus for medical trials.
I missed this post initially.
This is a sick joke Patriarch. To poke fun at a situation where six men may die and the emotionally sensitive topic of abortion I find unacceptable.
A sick joke? Sick perhaps, but I would hardly call it a joke.
https://www.wnd.com/news/printer-friendly.asp?ARTICLE_ID=22259
https://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=14317
I saw on the news just a few months ago a lady advocating the use of the unborn for medical experimentation. We already do experiments with embryos, and a fetus is just an old embryo.
We must find a way to balance the need to test the drugs on humans, against the desire not to permanently harm or kill the humans. A suggested compromise is to use humans that don’t have a right to life.
those links are from about 4 years ago patriarch?!
it is a mildly related issue and the statement "Maybe we should add another in between stage where mothers can volunteer their unwanted fetus for medical trials." is a great example of sensationalism alluding to a complex issue.
the last sentence there is a complete misrepresentation and does not relate to the opinion on either side of the debate.
cole. x
"i see you at 'dis cafe.
i come to 'dis cafe quite a lot myself.
they do porridge."
- tim westwood
GOLD Member
What a Bummer
3,224 posts
Location: Shatfield, Hertfordshire, United Kingdom
What a Bummer
3,224 posts
Location: Shatfield, Hertfordshire, United Kingdom
Posted:
Hey Doc, do you guys call it adrenalin or epinephrine over there? just out of curiosity...
Hey Doc, do you guys call it adrenalin or epinephrine over there? just out of curiosity...
GOLD Member
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Posted:
Like I said it's £5.95/hr- higher than minimum wage, but considerably lower than the average national hourly rate.
£1000- for a week is a pretty big sum, but it involves 7 days of 24 hour total restriction- you cannot leave the unit.
As for the payment being for the risk, not the time- I'm not so sure.
Remember that I've been in these units- not taking the drugs; the first time was as 'standby' (to step in if, for some reason, one of the volunteers dropped out on the first couple of days), the second on a non-drugs trial.
Even though they were only 2-night stays, I could extrapolate from that that spendings a week or more there what not be pleasant for most people.
It involves what amounts to imprisonment- you cannot leave (other than by sacrificing the payment) the small unit for any reason; you have to eat exactly what they provide (and the food during my stay was crap), you can't drink tea or coffee (which means you'll get withdrawel headaches if you normally drink a lot of tea/coffee).
In addition, every few hours staff will be collecting your blood with the enthusiasm of vampires
That's every few hours for the entire stay, either a fresh hole in the arm for each sample, or having to have a canula installed in a view for the duration. When you leave, your arm will look like a heroin addicts arm.
So, IMO, volunteers are not paid their £5.95/hr for the risk, but because their time their involves sufficient unpleasantness, that if the pay was lower, there would be very few willing to take part.
-------------
It seems to me that this incident is going to bring about big changes in UK testing.
Prior to this, no volunteers seriously thought, when considering the risk, that multiple organ failure was a possibility.
I say this cos I know a lot of people who've taken part in testing, i doubt that if they read the accounts of what happened to these six unfortunates, that they would ever consider volunteering again.
I doubt even the medical staff when talking about 'the risks' had anything like this in mind.
This incident was a unforseen nightmare, and I would imagine that many people who prior to this would happily have volunteered, are considerably less likely to do so in the future.
Bear in mind that students are a prime target for the marketing for these units (for example, they often have a stall at university freshers fair) and I think that this incident is going to be very much in parents minds when their 18 year old son is thinking of ways to tackle his increasing student debt (or daughter of course, though it's mainly males who end up doing these studies).
Surely as well, there are going to be changes in some procedures, the most obvious being not giving untested drugs to all volunteers simultaneously or within minutes of each other.
Bear in mind that the cost of a new drug from inception to market is generally around £550 million.
That being the case, putting in the necessary measures to try and ensure that this never happens again, isn't something to be skimped on.
Of course it will boost the costs of studies, but, compared to the total of £550 million, extra tens of thousands spent running extra studies with ultra low doses (for example) are surely worth spending money on?
Written by: coleman
Written by: OWD
£1000 pounds for a weeks stay sounds amazing, but bear in mind that you're in 24/7, no going outside, no tea/coffee (hence guaranteed 'caffiene headaches' for those who drink regualr tea/coffee') no choice in what you're going to eat for those seven days etc.
Divide £1000 by the number of hours you're actually 'working' for, and it comes out to £5.95/hr.
but that is a seriously large amount to get paid all day, every day, for a week when you have to do nothing and spend nothing whatsoever.
ask someone on minimum wage what they think of getting nearly six pounds an hour, plus food and a bed for doing no work at all - they'll probably ask "what's the catch?".
the answer is "there's a risk to your health as you have to take drugs never used on humans before".
it should be pretty obvious to anyone with even a modicum of sense that pharma trial companies are paying you for the risks you are taking with your health, not for your time.
i can see nothing wrong with presenting the tests as 'very safe' since statistically and qualatatively, they are.
Like I said it's £5.95/hr- higher than minimum wage, but considerably lower than the average national hourly rate.
£1000- for a week is a pretty big sum, but it involves 7 days of 24 hour total restriction- you cannot leave the unit.
As for the payment being for the risk, not the time- I'm not so sure.
Remember that I've been in these units- not taking the drugs; the first time was as 'standby' (to step in if, for some reason, one of the volunteers dropped out on the first couple of days), the second on a non-drugs trial.
Even though they were only 2-night stays, I could extrapolate from that that spendings a week or more there what not be pleasant for most people.
It involves what amounts to imprisonment- you cannot leave (other than by sacrificing the payment) the small unit for any reason; you have to eat exactly what they provide (and the food during my stay was crap), you can't drink tea or coffee (which means you'll get withdrawel headaches if you normally drink a lot of tea/coffee).
In addition, every few hours staff will be collecting your blood with the enthusiasm of vampires
That's every few hours for the entire stay, either a fresh hole in the arm for each sample, or having to have a canula installed in a view for the duration. When you leave, your arm will look like a heroin addicts arm.
So, IMO, volunteers are not paid their £5.95/hr for the risk, but because their time their involves sufficient unpleasantness, that if the pay was lower, there would be very few willing to take part.
-------------
It seems to me that this incident is going to bring about big changes in UK testing.
Prior to this, no volunteers seriously thought, when considering the risk, that multiple organ failure was a possibility.
I say this cos I know a lot of people who've taken part in testing, i doubt that if they read the accounts of what happened to these six unfortunates, that they would ever consider volunteering again.
I doubt even the medical staff when talking about 'the risks' had anything like this in mind.
This incident was a unforseen nightmare, and I would imagine that many people who prior to this would happily have volunteered, are considerably less likely to do so in the future.
Bear in mind that students are a prime target for the marketing for these units (for example, they often have a stall at university freshers fair) and I think that this incident is going to be very much in parents minds when their 18 year old son is thinking of ways to tackle his increasing student debt (or daughter of course, though it's mainly males who end up doing these studies).
Surely as well, there are going to be changes in some procedures, the most obvious being not giving untested drugs to all volunteers simultaneously or within minutes of each other.
Bear in mind that the cost of a new drug from inception to market is generally around £550 million.
That being the case, putting in the necessary measures to try and ensure that this never happens again, isn't something to be skimped on.
Of course it will boost the costs of studies, but, compared to the total of £550 million, extra tens of thousands spent running extra studies with ultra low doses (for example) are surely worth spending money on?
"You can't outrun Death forever.
But you can make the Bastard work for it."
--MAJOR KORGO KORGAR,
"Last of The Lancers"
AFC 32
Educate your self in the Hazards of Fire Breathing STAY SAFE!
BRONZE Member
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
Posted:
some more info I got out of the papers today...
- the drug was tested on bunnies and apes (or monkeys? dunno... it's the same word in German!), didn't read about dogs
- it was due to be tested in Germany first (it being from a German company), but since the testing process is much faster here and in the US they decided to do it in the UK
Dave you're right, it won't matter a bit for the costs, and even if it did, a company who isn't going to spend that extra-money will not only lose volunteers but also customers due to the bad reputation they'll get.
I disagree about the money though. If you're a student, unemployed (or according to the papers Eastern European, the 3rd biggest group to go for testing), 5.something an hour is way more than you usually earn. As a student, if you're studying hard you only CAN work for a few hours a day, and if you work every night and on weekends you'll have just as much social life as you would in the hospital. With the average wages you calculated you also get paid while you're sleeping, and I'm sure you can take your study materials and spend the time in a useful way.
As for the vampires drawing blood, it's part of what they pay for so get used to it... the people you're doing the study for, chronically ill people, get it done regularly without being paid, and often even get moaned at by nurses etc for not having good enough veins
some more info I got out of the papers today...
- the drug was tested on bunnies and apes (or monkeys? dunno... it's the same word in German!), didn't read about dogs
- it was due to be tested in Germany first (it being from a German company), but since the testing process is much faster here and in the US they decided to do it in the UK
Dave you're right, it won't matter a bit for the costs, and even if it did, a company who isn't going to spend that extra-money will not only lose volunteers but also customers due to the bad reputation they'll get.
I disagree about the money though. If you're a student, unemployed (or according to the papers Eastern European, the 3rd biggest group to go for testing), 5.something an hour is way more than you usually earn. As a student, if you're studying hard you only CAN work for a few hours a day, and if you work every night and on weekends you'll have just as much social life as you would in the hospital. With the average wages you calculated you also get paid while you're sleeping, and I'm sure you can take your study materials and spend the time in a useful way.
As for the vampires drawing blood, it's part of what they pay for so get used to it... the people you're doing the study for, chronically ill people, get it done regularly without being paid, and often even get moaned at by nurses etc for not having good enough veins
"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
GOLD Member
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Carpal \'Tunnel
3,252 posts
Location: sheffield, United Kingdom
Posted:
Of course, part of what you're getting paid for is the drawing of blood; I was just pointing out that it's one of the many unpleasant aspects of being in a research unit.
It's far from the well paid holiday break that some seem to assume- you do get paid and, though I still maintain it's not the riches that some seem to think, it is quite a lot of money, but,it's well deserved cos of the negative aspects of the stay- every penny is well earnt,worked for and well deserved
Of course that was until this current horrific accident- the stakes have been raised somewhat now as no amount of money is going to balance any realistic future risk of this happening again.
As for the people who volunteer; technically, where the unemployed are concerned, there's no point going on a study as its effects on benefits when declared negates any profit.
In reality, the companies running such studies make it clear that, though declaring the earnings is a legal requirement, they won't bother if you don't.
Where students are concerned, they are indeed very attracted, especially in the UK where there is genuine student poverty and where, for some, going on these studies is the only way they can complete their courses.
Latest news on the TV is that several of the victims are making some progress and having their levels of life support reduced.
I've been finding it hard to keep this out of my mind, having been in Leeds on a pre-study medical on the day the news came out , and also having several friends who've been on these studies; it's all a bit 'close to home' and I'm in a bit of a dazed/shocked state having read some graphic accounts of what happened to these guys.
I'm trying hard not to be negative about these studies- I'm just pointing out the genuine hardships they involve and trying to tackle the view that I know some have, which is that these guys knew the risks and were getting easy money for doing very little- that is totally not the case.
They did not know the risks in any meaningful sense of the word and they weren't getting paid loads for doing little. More important, they could have been any number of people that I know and, for those of you who're going to have kids who go to university, it could easily be them in the future.
Of course, part of what you're getting paid for is the drawing of blood; I was just pointing out that it's one of the many unpleasant aspects of being in a research unit.
It's far from the well paid holiday break that some seem to assume- you do get paid and, though I still maintain it's not the riches that some seem to think, it is quite a lot of money, but,it's well deserved cos of the negative aspects of the stay- every penny is well earnt,worked for and well deserved
Of course that was until this current horrific accident- the stakes have been raised somewhat now as no amount of money is going to balance any realistic future risk of this happening again.
As for the people who volunteer; technically, where the unemployed are concerned, there's no point going on a study as its effects on benefits when declared negates any profit.
In reality, the companies running such studies make it clear that, though declaring the earnings is a legal requirement, they won't bother if you don't.
Where students are concerned, they are indeed very attracted, especially in the UK where there is genuine student poverty and where, for some, going on these studies is the only way they can complete their courses.
Latest news on the TV is that several of the victims are making some progress and having their levels of life support reduced.
I've been finding it hard to keep this out of my mind, having been in Leeds on a pre-study medical on the day the news came out , and also having several friends who've been on these studies; it's all a bit 'close to home' and I'm in a bit of a dazed/shocked state having read some graphic accounts of what happened to these guys.
I'm trying hard not to be negative about these studies- I'm just pointing out the genuine hardships they involve and trying to tackle the view that I know some have, which is that these guys knew the risks and were getting easy money for doing very little- that is totally not the case.
They did not know the risks in any meaningful sense of the word and they weren't getting paid loads for doing little. More important, they could have been any number of people that I know and, for those of you who're going to have kids who go to university, it could easily be them in the future.
"You can't outrun Death forever.
But you can make the Bastard work for it."
--MAJOR KORGO KORGAR,
"Last of The Lancers"
AFC 32
Educate your self in the Hazards of Fire Breathing STAY SAFE!
BRONZE Member
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
had her carpal tunnel surgery already thanks v much
4,145 posts
Location: Edinburgh, Scotland (UK)
Posted:
for you, Dave!
Noone says volunteers are doing little, they're risking their lives for others, and that's one of the biggest sacrifices anyone can make.
I think I just disagreed with your 5-something an hour... that just doesn't measure it, and neither does drawing blood.
The knowing the consequences however is something I stand by. Noone knows if a drug you volunteer for can kill you or cause cancer or leave you infertile or something, that's why there are trials... though of course the companies probably won't put it to you like that when you sign up
Glad to hear the guys are getting better, though one of my papers said today that one of them might be in a coma for a year :cry:
for you, Dave! Noone says volunteers are doing little, they're risking their lives for others, and that's one of the biggest sacrifices anyone can make.
I think I just disagreed with your 5-something an hour... that just doesn't measure it, and neither does drawing blood.
The knowing the consequences however is something I stand by. Noone knows if a drug you volunteer for can kill you or cause cancer or leave you infertile or something, that's why there are trials... though of course the companies probably won't put it to you like that when you sign up
Glad to hear the guys are getting better, though one of my papers said today that one of them might be in a coma for a year :cry:
"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
Pooh-Bah
1,662 posts
Location: Bristol
1,662 posts
Location: Bristol
Posted:
does anyone think it'll affect people volunteering for future testing?
do you think it could have a bad impact, or will people go for it anyway? i wonder.....
does anyone think it'll affect people volunteering for future testing?
do you think it could have a bad impact, or will people go for it anyway? i wonder.....
I had a dream that my friend had a
strong-bad pop up book,
it was the book of my dreams.
GOLD Member
What a Bummer
3,224 posts
Location: Shatfield, Hertfordshire, United Kingdom
What a Bummer
3,224 posts
Location: Shatfield, Hertfordshire, United Kingdom
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.
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.
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