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Drug Trial Men given £10k

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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    when i was experimenting with drugs on a full time basis ...they were trying to give me ten years not ten grand.

    :D:D

    Whats more your experimentation has been beneficial to others - judging by your regard in the drugs forum. :thumb:
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    There's a BBC2 documentary tomorrow night on some of the unethical practices of drug companies in using developing world citizens as guinea pigs without their informed consent. Might put some perspective on the mindset that prevails in big pharma.
    This is the plot of the recent Fernando Meirelles film, "The Constant Gardener". I wasn't sure to what extent the film was fiction when I watched it.

    But as for the British case, if it was informed consent (which as far as I know it was) then I agree with Kermit. If they were mis-lead about the risks then that's another matter.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    They were informed of side effects, not of danger of death. Looks like the lawyers will face negligence charges if you are right Kermit, because they obviously were negligent not to write a waver for the eventuallity of death!
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Randomgirl wrote:

    But as for the British case, if it was informed consent (which as far as I know it was) then I agree with Kermit. If they were mis-lead about the risks then that's another matter.

    http://news.bbc.co.uk/1/hi/health/4744432.stm

    Clinical trial patients may mistakenly believe they would be compensated for accidental harm because of badly worded contracts, a senior doctor has warned.

    University of London Professor Desmond Laurence told the British Medical Journal that injury pay-out decisions were at the trial sponsor's discretion.

    The government, which vets contracts, said patients are told the full risks.

    There have been reports of heart problems and damage to blood cells after adverse reactions to drugs.

    Prof Laurence said patients who took part in trials deserved to have the consumer contracts adequately explained to them. as they are doing society a service.

    But he said documents were not written in plain language, and therefore did not meet the legal requirement of fairness and openness under consumer law.

    In his letter to the BMJ, he cited the wording of the government-agreed statement: "[The sponsor] will pay compensation for [non-negligent harm]. Any payment would be without legal commitment."

    He said the certainty of the first sentence was undone by the "legal jiggery-pokery" of the second.

    "If the law were to be observed, patients would be told frankly, in words lay people could readily understand, that they might be seriously injured but with merely discretionary compensation.

    "The trial sponsor of course may always pay ex-gratia compensation, if it cares to.

    "But if it does not, then the cost of compensation for non-negligent harm falls up on the injured patients themselves."

    He acknowledged that if it was spelt out clearly to people they were not entitled to compensation, the numbers volunteering for trials might drop.

    But he added the answer then would be to introduce "more humane compensation arrangements".

    Louise Hunt, a partner at Alexander Harris solicitors, which specialises in medical cases, said patients had a right to know what their rights were when volunteering for trials.

    "The issues Prof Laurence raises are very worrying. Patients should have things fully explained to them and it is naive of the government and trial sponsors to think they do not have to do this.

    "It sounds like it is very confusing for patients, I think they should be entitled to compensation."

    But a Department of Health spokeswoman said: "We do not agree with Prof Laurence that patients are being misled.

    "People take part in clinical trials with consent, after seeing information about the risks.

    "It is a key part of the job of an ethics committee to examine carefully the information that goes to patients and others to make sure they know about the risks and the kind of compensation available before they consent to take part."
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Interesting, but as its a doctor not a lawyer saying it I would take it with quite a bit of salt to be honest.

    If it isn't negligent the company doesn't have to legally pay a penny; they will do, though, for publicity and ethical reasons.

    Of course the people should get some money, I should clarify that, but the point is they're not legally entitled to anything, and the company were not negligent. You cannot sign up to something with risks and then moan that its someone else's fault when you get bitten on the bum.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kermit wrote:
    Interesting, but as its a doctor not a lawyer saying it I would take it with quite a bit of salt to be honest.

    Of course the people should get some money, I should clarify that, but the point is they're not legally entitled to anything, and the company were not negligent. You cannot sign up to something with risks and then moan that its someone else's fault when you get bitten on the bum.

    But surely only a doctor (scientist, or someone of equivalent medical knowledge) would have the ability to understand the risks of such experiments, and therefore make an 'informed decision' to take part.

    Thus it is not a matter of simply knowing that 'there are risks involved,' it is a matter of understanding the nature and extent of those risks. By your logic informing someone that 'there are risks involved' gives a carte blanche to do whatever you like to them.

    To use a bad (but illustrative) analogy: I enter a casino, walk up to a roulette table and place a £10 bet on red. The ball lands on black. Security drag me outside, kick the hell out of me, take all my money and my car. "Sorry mate - you knew there were risks involved, now piss off and stop moaning."
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    theres a program on sometime this week talking about how people in poor countries are told they're recieving practical treatment, when actually they're the guinea pigs.....
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    carlito wrote:
    a bad analogy
    That's the only bit of your post I agree with.

    A risk, however miniscule, of taking any medication is an adverse reaction causing death. That should be made absolutely clear to anyone who subjects themselves voluntarily to medical research, but that risk should also be put into context and the fact that this is the first such catastrophic adverse drug reaction for decades should be borne in mind.

    And, by the way, it doesn't matter if they spend the money on a holiday or their tuition fees - they were paid to take an experimental drug and paid handsomely. If you want to remove the risk from the experiments, you remove the need to pay the volunteers vast sums of money for their time.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    That's the only bit of your post I agree with.

    A risk, however miniscule, of taking any medication is an adverse reaction causing death. That should be made absolutely clear to anyone who subjects themselves voluntarily to medical research, but that risk should also be put into context and the fact that this is the first such catastrophic adverse drug reaction for decades should be borne in mind.


    there is actually a small but very signifigant risk of the treatment they were given, killing you

    they werent not told that the possible side effect is life threatening, end of
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    there is actually a small but very signifigant risk of the treatment they were given, killing you
    Small but significant? What does that mean? Any risk of death is significant for most people, surely.
    they werent not told that the possible side effect is life threatening, end of
    Based on the earlier research, the problems they encountered wouldn't have been anticipated. I don't know what else could have been done, apart from telling them they might die. It suits the lawyers, but without a context I don't think that qualifies as informed consent either.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    That's the only bit of your post I agree with.

    A risk, however miniscule, of taking any medication is an adverse reaction causing death. That should be made absolutely clear to anyone who subjects themselves voluntarily to medical research, but that risk should also be put into context and the fact that this is the first such catastrophic adverse drug reaction for decades should be borne in mind.

    Thats not true - a cursory search led me to:
    "A woman developed mental health problems and later died after taking part in trials of a cannabis-based drug, an inquest has heard.
    Diabetic Rene Anderson, aged 69 from Sheffield, was taken to hospital after starting to take Sativex to see if it would relieve pain she was suffering. She died in March 2004 from acute kidney failure."
    http://news.bbc.co.uk/1/hi/england/south_yorkshire/4522108.stm
    Kentish wrote:
    And, by the way, it doesn't matter if they spend the money on a holiday or their tuition fees - they were paid to take an experimental drug and paid handsomely. If you want to remove the risk from the experiments, you remove the need to pay the volunteers vast sums of money for their time.

    This is precisely the point - very few people actually want to volunteer for medical research. That is why they are paid, and why affluent people do not take part in them. But they are necessary in order to produce new drugs, which should (ostensibly) benefit the rest of humanity. It is therefore in everybody's interest that volunteers continue to come forward. Dismissing those who have experienced the worst results of these experiments as "moaners" and fobbing them off with token sums of money is going to decrease the numbers willing to take part in these experiments. So you have two options:

    1) Put safeguards in place to ensure that when things do go wrong, victims are adequately treated, compensated, and minimise their impact on the numbers of subsequent volunteers. A miniscule portion of the huge profits of the pharmaceutical companies would easily provide this.

    2) Rely on the fact that many people are so desperate for money that they are willing to take huge gambles with their health, their employability, and their lives. Let them 'choose' to gamble (for our benefit) and tell them to shut the fuck up when something goes wrong. This is called exploitation.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    carlito wrote:
    Thats not true - a cursory search led me to:
    "A woman developed mental health problems and later died after taking part in trials of a cannabis-based drug, an inquest has heard.
    Diabetic Rene Anderson, aged 69 from Sheffield, was taken to hospital after starting to take Sativex to see if it would relieve pain she was suffering. She died in March 2004 from acute kidney failure."
    http://news.bbc.co.uk/1/hi/england/south_yorkshire/4522108.stm
    A 69 year old diabetic with serious health problems is slightly different from young healthy men, don'tcha think?
    token sums of money
    Token sums? £10k seems like quite a lot of money to me.
    1) Put safeguards in place to ensure that when things do go wrong, victims are adequately treated, compensated, and minimise their impact on the numbers of subsequent volunteers.
    Hang on, what is the money for? Is it to pay for treatment? Or to compensate for the inconvenience of being in hospital for months? Or is it to maintain numbers of volunteers for future experiments? I think you're getting confused in your arguments.
    A miniscule portion of the huge profits of the pharmaceutical companies would easily provide this.
    Why should that have any bearing at all? By extension, catastrophic failures by smaller and less successful drug companies would result in reduced payments for victims. Is that what you mean or do you just want to rob the profits of big pharma?
    2) Rely on the fact that many people are so desperate for money that they are willing to take huge gambles with their health, their employability, and their lives. Let them 'choose' to gamble (for our benefit) and tell them to shut the fuck up when something goes wrong. This is called exploitation.
    Again, you're getting confused. If you are arguing for clearer explanations of the risks, that is one thing. But then to argue that once the risk becomes reality they need additional payment then you end up with a system of payment-by-symptom. They are exploited insofar as we are all exploited by our employers to work for less than we would like, and doing jobs that impact on our social and family lives. I think you'll find that most volunteers are not necessarily those who are "desperate" but those who have time on their hands and who are generally healthy (i.e. male students).
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    I think there has to be a balance between expected/not life threatening side effects and extensive, comprehensive life threatening side effects.

    You could argue that some subjects developing a moderate reaction, or maybe one of them a severe allergic reaction to the drugs was covered in the terms of the contract.

    Every single subject suffering ultra violent, life threatening reactions that included heads ballooning up to 3 times their normal size, people being in a coma for potentially 1 year and folks losing their fingers and toes are clearly outside the expected risks and side effects. One person experiencing them, you could argue he had a particular allergic sensitivity to it. Most or all of them doing it is something else altogether and indicates a fuck up.

    As such the company should compensate, and compensate handsomely at that.

    Those of you complaining about 'compensation culture' should stop and reflect on the facts that drug companies are multi-million pound operations and can certainly fucking afford a lot more than 10k per victim without even noticing it. It's not the boardroom directors who are putting their lives on the line here.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Aladdin wrote:
    Most or all of them doing it is something else altogether and indicates a fuck up.
    Who "fucked up"? If we are to believe the preliminary reports, this was an unanticipated reaction. You can bet your bottom dollar it will be anticipated in future trials, but surely medicine is subject to trial and error, learning based on experience?
    As such the company should compensate, and compensate handsomely at that.

    Those of you complaining about 'compensation culture' should stop and reflect on the facts that drug companies are multi-million pound operations and can certainly fucking afford a lot more than 10k per victim without even noticing it. It's not the boardroom directors who are putting their lives on the line here.
    Again, does the value of human life vary depending on the profitability of a drug company? I'm staggered by the illogical arguments being presented here.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    A 69 year old diabetic with serious health problems is slightly different from young healthy men, don'tcha think?

    Yes, it is slightly different, but it still illustrates what is essentially the same dilemma, and also proves your previous assertion false.

    Token sums? £10k seems like quite a lot of money to me.

    Maybe thats because you aren't facing the prospect of your fingers and toes falling off.
    http://news.bbc.co.uk/1/hi/health/4914546.stm
    Hang on, what is the money for? Is it to pay for treatment? Or to compensate for the inconvenience of being in hospital for months? Or is it to maintain numbers of volunteers for future experiments? I think you're getting confused in your arguments.

    All of those things: it is compensation. Money to try and minimize the pain/irritation/general disadvantages of an event.
    Why should that [scale of profits of pharmaceuticals] have any bearing at all? By extension, catastrophic failures by smaller and less successful drug companies would result in reduced payments for victims. Is that what you mean or do you just want to rob the profits of big pharma?

    No, it shows that it is a practical proposition.
    Again, you're getting confused. If you are arguing for clearer explanations of the risks, that is one thing. But then to argue that once the risk becomes reality they need additional payment then you end up with a system of payment-by-symptom. They are exploited insofar as we are all exploited by our employers to work for less than we would like, and doing jobs that impact on our social and family lives. I think you'll find that most volunteers are not necessarily those who are "desperate" but those who have time on their hands and who are generally healthy (i.e. male students)

    I am simply arguing for some honesty on this issue: we rely on these people taking risks in order to develop and distribute drugs that can save lives, and make others more bearable. Since there is an inherent risk in these trials it is necessary to pay people (who would not otherwise be inclined) to participate. If you want people to continue to participate you have the two options I previously outlined. Personally, I consider the first to be more desirable (whilst not perfect) and potentially effective.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Of course it goes without saying that any long term sequelae of taking part in a drugs trial should be adequately compensated based on the disability. Losing fingers and toes is unacceptable and should be compensated with cash. That I have no problem with. But the argument that they should be given wads of cash simply because they suffered adverse effects is illogical.

    And you'll have to take my word for it that this trial was unprecedented in the effects it on the participants.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    Of course it goes without saying that any long term sequelae of taking part in a drugs trial should be adequately compensated based on the disability. Losing fingers and toes is unacceptable and should be compensated with cash. That I have no problem with. But the argument that they should be given wads of cash simply because they suffered adverse effects is illogical.

    And you'll have to take my word for it that this trial was unprecedented in the effects it on the participants.

    Specific effects, yes: and I don't have to take your word for it as my father is a journalist specializing in the medical industry and has been researching this story for some time. That there is no specific precedent is precisely why it is important this problem be discussed properly and without simply dismissing its victims as "moaners" who knew full well what they were in for when they signed up.

    I don't see how compensation based on suffering is illogical - if it is significant and verifiable (as the victims in this case) then it would mitigate this disincentive to potential volunteers, and provide an incentive for pharmaceuticals to fully scrutinize each compound they intend to trial. Clearly minor discomfort or temporary and impermanent side effects go with the territory here. But surely those who suffer severe or permanent side effects should be generously compensated for their suffering. If an adverse precedent were set the drugs companies - what are fundamentally profit-driven, bureaucratic organizations - would push it as far as it would go, and probably beyond. Only the desperate would volunteer for such testing. Personally I do not wish to live in such a society, or rely upon products of such a process.

    If you are comfortable with this, be it upon your conscience. Perhaps you can offer a solution involving prisoners or participants randomly conscripted from the population when the volunteers dry up or. Or alternatively you could step up yourself and volunteer - I'd assume you would accept a simple apology if something went wrong.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    I've volunteered before for trials but that isn't the point. You fail to mention that interest in taking part in drugs trials has actually gone up since this story broke.

    How else do you suggest drugs are developed if not for profit?
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    Small but significant? What does that mean? Any risk of death is significant for most people, surely.

    Based on the earlier research, the problems they encountered wouldn't have been anticipated. I don't know what else could have been done, apart from telling them they might die. It suits the lawyers, but without a context I don't think that qualifies as informed consent either.

    im not a medical expert, i saw the form they signed, and it mentions the risk of the problem they had in medical terms, it doesnt say this is life threatening



    in terms of risk for the 1st part, i mean there is more than no risk, but not that big risk - it's like a vaccine what was being tested, so the cahcnes of a full blown immune response are signifigant, but not large enough to not do human trials, they should just be informed so they can consent
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    im not a medical expert, i saw the form they signed, and it mentions the risk of the problem they had in medical terms, it doesnt say this is life threatening



    in terms of risk for the 1st part, i mean there is more than no risk, but not that big risk - it's like a vaccine what was being tested, so the cahcnes of a full blown immune response are signifigant, but not large enough to not do human trials, they should just be informed so they can consent
    If I was the volunteer and you told me the risk of taking the drug was significant, how do you expect me to interpret that?
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    I've volunteered before for trials but that isn't the point. You fail to mention that interest in taking part in drugs trials has actually gone up since this story broke.

    How else do you suggest drugs are developed if not for profit?

    Personally I would advocate an entirely non-profit driven society - but since I am arguing against those who (I assume) would not be immediately persuaded to accept this as a premise, I am satisfied to argue a more moderate stance: that the worst consequences of such a paradigm be minimized by legislation based on the argument I suggested. If not, perhaps refusal of volunteers to participate would hopefully force the pharmaceuticals to take a more ethical stance towards this process. The latter I realise is unrealistic, since I imagine that too many volunteers are too desperate for the money for a boycott or strike to be effective, and organization of such a fragmented group of people is unrealistic.

    That interest in participation in drugs trials has increased in the immediate afermath of this story is unsuprising: it is an obscure enough process that coverage in the national media is bound to increase awareness of the potential financial benefits involved, and therefore further participation - particularly amongst the uncritical and ill-informed (it is noticeable the weight the red-tops have given to this story).
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Less of the banalities, a little more argument, if you please.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    If I was the volunteer and you told me the risk of taking the drug was significant, how do you expect me to interpret that?


    well there isa prevalent risk

    and im not the one giving professional advice to patients and i dont know the exact figure, to my knowledge the chance of this side effect occuring isnt really low like 1 in a million, but it isnt like 10% either as it wouldnt get to human trials at that point

    and it is danger money for a reason, i was considering going in for volunterring on testing typhoid vaccines, but i have exams to revise for and thus the minor illness as a side effect i wasnt prepared to take

    you are either prepared to accept the risk or you arent in these kind of things, but you should be told honestly the risks involved, if you arent made aware that one of the possible side effects can kill you by just mentioning the medical term in the consent form, then imo you deserve compensation
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    Less of the banalities, a little more argument, if you please.

    :confused:
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    well there isa prevalent risk
    I don't know what you mean by that. :confused:
    if you arent made aware that one of the possible side effects can kill you by just mentioning the medical term in the consent form, then imo you deserve compensation
    Or, looking at it another way, if you sign a consent form that you don't fully understand and have not asked to be clarified, you only have yourself to blame.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    Who "fucked up"? If we are to believe the preliminary reports, this was an unanticipated reaction. You can bet your bottom dollar it will be anticipated in future trials, but surely medicine is subject to trial and error, learning based on experience?
    Well that's why we test on animals first isn't it? One thing is experiencing an adverse reaction, another is administering a substance so vicious they might as well have injected them with sulphuric acid.
    Again, does the value of human life vary depending on the profitability of a drug company? I'm staggered by the illogical arguments being presented here.
    No, the value of a human life cannot be quantified. However there is common sense and common decency that tells us all what might be an appropriate compensation, and what isn't.

    10k is a fucking pisstake. Especially from a company that could afford many, many times more.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    carlito wrote:
    :confused:
    If your main point is that exploitation of the poor is bad, and huge profits are bad, and drugs should be developed without risk, then the discussion is pointless but to actually discuss the debatable parts of the story is what this thread is about.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Aladdin wrote:
    Well that's why we test on animals first isn't it? One thing is experiencing an adverse reaction, another is administering a substance so vicious they might as well have injected them with sulphuric acid.
    But how were they to know that if the animal tests had gone without the same effect? Indeed, the dose given to the men was a fraction of that given in the animal tests. Was the company negligent to perform the trial, or was their mistake not to have fully informed the participants of the risk? If the latter, how would you expect them to quantify the risk?
    No, the value of a human life cannot be quantified. However there is common sense and common decency that tells us all what might be an appropriate compensation, and what isn't.

    10k is a fucking pisstake. Especially from a company that could afford many, many times more.
    Go ahead, suggest a more appropriate figure.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    But how were they to know that if the animal tests had gone without the same effect? Indeed, the dose given to the men was a fraction of that given in the animal tests. Was the company negligent to perform the trial, or was their mistake not to have fully informed the participants of the risk? If the latter, how would you expect them to quantify the risk?
    Well I'm not scientist but unless the drug in question involved agents never before tried on humans (which I doubt), it does appear as a serious failure some point along the line that a substance so damaging and dangerous could be administered to a person.
    Go ahead, suggest a more appropriate figure.
    50k for the less serious cases, 100k+ for anyone who's lost fingers/toes or is going to be ill/incapacitated for several months, raising to 1-2m to anyone who suffers permanent disability/brain damage.
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    Former MemberFormer Member Posts: 1,876,323 The Mix Honorary Guru
    Kentish wrote:
    If your main point is that exploitation of the poor is bad, and huge profits are bad, and drugs should be developed without risk, then the discussion is pointless but to actually discuss the debatable parts of the story is what this thread is about.

    That is not my main point, hence:
    Myself wrote:
    ...since I am arguing against those who (I assume) would not be immediately persuaded to accept this as a premise...

    Your only question was:
    How else do you suggest drugs are developed if not for profit?

    My reply was:
    Myself wrote:
    Personally I would advocate an entirely non-profit driven society - but since I am arguing against those who (I assume) would not be immediately persuaded to accept this as a premise, I am satisfied to argue a more moderate stance: that the worst consequences of such a paradigm be minimized by legislation based on the argument I suggested. If not, perhaps refusal of volunteers to participate would hopefully force the pharmaceuticals to take a more ethical stance towards this process. The latter I realise is unrealistic, since I imagine that too many volunteers are too desperate for the money for a boycott or strike to be effective, and organization of such a fragmented group of people is unrealistic.

    If you ask a broad question, expect a broad reply. That is given in the first 30 words. The remaining 60 are discussing the debatable aspects of the story that you refer to. Your other point was:
    Kentish wrote:
    You fail to mention that interest in taking part in drugs trials has actually gone up since this story broke.

    My response was:
    Myself wrote:
    That interest in participation in drugs trials has increased in the immediate afermath of this story is unsuprising: it is an obscure enough process that coverage in the national media is bound to increase awareness of the potential financial benefits involved, and therefore further participation - particularly amongst the uncritical and ill-informed (it is noticeable the weight the red-tops have given to this story).
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