watervole: (Default)
Judith Proctor ([personal profile] watervole) wrote2012-01-30 08:51 am

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.

[identity profile] sammason.livejournal.com 2012-01-30 09:18 am (UTC)(link)
Over here, no you're not expected to pay to take part in drug trials. The people running the trial aren't allowed to pay you either except to reimburse expenses that were incurred for the trial's sake.

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.

[identity profile] wibble-puppy.livejournal.com 2012-01-30 12:08 pm (UTC)(link)
I'm so sorry your friend is so ill. Thinking of you both.

[identity profile] reapermum.livejournal.com 2012-01-30 01:18 pm (UTC)(link)
The local science society had a talk a couple of weeks ago on clinical trials and no mention was made of payments either way, except they're not allowed to pay people to take part. This is EU regulations.

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.

[identity profile] oreouk.livejournal.com 2012-01-30 02:02 pm (UTC)(link)
Research suggests that yes, in the US it is not infrequent that the patient would have to pay for the drugs given to him and that it's one of the factors they need to take into consideration before agreeing to go on a trial. The patient would have the rules that will apply to the trial they are signing up for set out for them when they joined the trial (I read some variant on that on multiple sites - it's up to the people running the trial what rules they want to set on cost coverage, so there is no standard set of rules and each contract would have to be considered individually).

Personally I am appalled by this, but then I'm equally appalled by America's health system in general.
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[identity profile] watervole.livejournal.com 2012-01-30 03:33 pm (UTC)(link)
I'm appalled by it also. He knew he would have to pay when he entered the trial, but to have to pay when the treatment has not worked seems particularly cruel.

Reading between the lines, I fear he has less than a year to live. In that kind of circumstance, you'll agree to anything.

[identity profile] despotliz.livejournal.com 2012-01-30 03:21 pm (UTC)(link)
I think it's accepted in the US to pay for clinical trials - it was one reason why families were raising so much money to go for treatment at the Burzynski clinic (http://www.quackometer.net/blog/2011/11/the-false-hope-of-the-burzynski-clinic.html), where they would be given controversial treatment as part of a clinical trial.

[identity profile] melodyclark.livejournal.com 2012-01-30 06:51 pm (UTC)(link)
Unfortunately, yes, it's now standard, thanks to the GOP and the spineless Democrats. The only salvation is that our bankruptcy laws do not preclude people from writing off medical debt. No one is going to drag him to the poor house -- they haven't reenacted those ... yet.

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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[identity profile] watervole.livejournal.com 2012-01-31 10:25 am (UTC)(link)
From his description it was hell. He was vomiting almost non-stop to begin with and was totally debilitated. He felt terrible, it was only the hope of a cure that enabled him to carry on with the trial.

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.

[identity profile] vjezkova.livejournal.com 2012-01-30 08:07 pm (UTC)(link)
Hmm. I myself have taken part in a medical trial for Herpes treatment, the same conditions (Placebo or drug - I never know). I received a proper explanation of the project, the importance and possible risks. This is a final trial before the vaccine is manufactured and distributed. The trial lasts three years, every month I receive a call and I am asked about possible side effects, then I will visit the research centre for a big check up.
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!

[identity profile] smellee17.livejournal.com 2012-01-31 03:24 am (UTC)(link)
That sounds incorrect. Study drug should always be provided free of charge. Have him check the informed consent document signed at the start. It will spell out exactly what is owed/not owed. For the US, the ICH guidelines say the consent must contain:

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