Medical trials
An American friend of mine has been taking part in a medical trial of a treatment for Hepatitis C.
He's just been taken out of the trial as he's not responded well enough to the medication and apparently there is a risk of drug resistance being created if he's left on it for too long.
He's just about to find out if he was on the drug or the placebo (though given the severity of the side-effects he was experiencing, I'm pretty sure he was on the drug).
He says that the agreement he signed means that if he was on the actual drug (which he will know soon), then he will have to pay for the treatment (though it will be free if he was on the placebo).
Is it normal to have to pay to take part in trials?
I fear for him. His health has been getting worse and worse in the time I've known him because of the Hepatitis, but the drug treatment took a terrible toll. He was highly motivated to take part in the trial because his life expectancy is not good at all.
He's just been taken out of the trial as he's not responded well enough to the medication and apparently there is a risk of drug resistance being created if he's left on it for too long.
He's just about to find out if he was on the drug or the placebo (though given the severity of the side-effects he was experiencing, I'm pretty sure he was on the drug).
He says that the agreement he signed means that if he was on the actual drug (which he will know soon), then he will have to pay for the treatment (though it will be free if he was on the placebo).
Is it normal to have to pay to take part in trials?
I fear for him. His health has been getting worse and worse in the time I've known him because of the Hepatitis, but the drug treatment took a terrible toll. He was highly motivated to take part in the trial because his life expectancy is not good at all.
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In America I think the rules might be different. And there are countries in which people sell their own or their children's organs for money.
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It was a very good talk covering all aspects that could be fitted into just over an hour plus questions. It ran from the legal obligation to run animal tests to should thalidomide be proscribed as an anti-cancer drug, given it's know side effects.
I hope your friend gets the care he needs.
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Personally I am appalled by this, but then I'm equally appalled by America's health system in general.
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Reading between the lines, I fear he has less than a year to live. In that kind of circumstance, you'll agree to anything.
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If it's anything like what a friend of mine went through on Interferon, I can imagine he's going through hell. I'm so sorry.
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The scary factor about making people pay is that there's nothing to stop companies doing trials of stuff that has little chance of working if they know they'll get money anyway. They can try stuff with the long odds and desperate people will try anything.
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You say he should pay? It sounds like a bad joke! We who are involved get paid for that - not much but still a pleasant sum... and in case of receiving placebo, also free vaccination with the stuff if we wish!
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The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks.
(j) The compensation and/or treatment available to the subject in the event of trial-related injury.
(k) The anticipated prorated payment, if any, to the subject for participating in the trial.
(l) The anticipated expenses, if any, to the subject for participating in the trial.
(m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
More here: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf