Stumbled across a story on the BBC regarding HIV/Aids deaths. One paragraph that jumped out at me was this:

Dr Dianna Gibb and colleagues studied 541 children with HIV symptoms aged between one and 14 living in Zambia, where drug resistance to common antibiotics is widespread. [...] After about 19 months, a quarter of the children who had been taking co-trimoxazole had died, compared with more than 40% of the children who had been given the dummy drug - full story (http://news.bbc.co.uk/1/hi/health/4021887.stm)

This is amazing! How did they choose which children to "kill" by giving them the dummy drug? I appreciate the point of the story is regarding the good news that the drug appears to work - but that doesn't distract from the point they gave some children dummy drugs!

Opinions/thoughts...?

God knows how they get away with it, although the fact is most people wouldn't notice the bad implications of the story, just the positive ones.

I don't think they know who gets the placibo untilt the trial ends, so no-one realy chooses who dies, it's random.

As for testing it on children, if it gave some of them more chance of living and could help find a cure/vaccine then I can't knock it.

Originally posted by Geoff
Stumbled across a story on the BBC regarding HIV/Aids deaths. One paragraph that jumped out at me was this:

Dr Dianna Gibb and colleagues studied 541 children with HIV symptoms aged between one and 14 living in Zambia, where drug resistance to common antibiotics is widespread. [...] After about 19 months, a quarter of the children who had been taking co-trimoxazole had died, compared with more than 40% of the children who had been given the dummy drug - full story (http://news.bbc.co.uk/1/hi/health/4021887.stm)

This is amazing! How did they choose which children to "kill" by giving them the dummy drug? I appreciate the point of the story is regarding the good news that the drug appears to work - but that doesn't distract from the point they gave some children dummy drugs!

Opinions/thoughts...?

This is a standard way of testing drug treatments. "Placebo" effects have to be accounted for to do a proper scientific study. And of course the idea of the testing is to see if the drugs are effective - they may well do no more good than a placebo.

Surely in this experiment, the control element would be those children that they didn't reach. Giving a dummy drug seems rather pointless when the continued death of 1000s of children is evidence enough of what no cure (i.e. the same difference as taking a 'dummy' drug) does...? Didn't they just give false hope to the children and their parents?

That's how drugs always get tested, as far as I know.

Happen in the 'developed world' when people sign up for drugs trials as well as in the developing world.

But in most cases, when people sign up for drug testing, it's not a matter of life or death. What I'm saying is that giving those children a dummy drug gave them false hope - which is unnecessary as there are plenty of children dying every day from no treatment, which they could have used for their comparison.

I'm not sure of the stats to back this up, but I think the idea is that if you gave 100 children a dummy drug and 100 children no drug then there would be a noticable difference in results. You are assuming that there would be no difference.

That is what the "placebo effect" is.

But, as I say, I'm not sure of the actual figures on how big the placebo effect can be.

They wouldn't have "chosen" which children to administer the drugs to and which to receive the dummy or control. They would have selected each group randomly.

In addition I think the study would have been double blind i.e. neither the researchers/doctors nor the children would have known which group they were in until the end of the trial.

Originally posted by Yodameister
That is what the "placebo effect" is.
What I'm saying is - is it right to test the placebo effect when we are talking about life and death of a child? With this kind of disease surely the effect of a placebo is likely to have minimal impact on the end result - death. It just seems a little 'wrong' to knowingly allow a group of children, who you have would have been better off 'risking it' with the drug, to die.

Originally posted by Geoff
What I'm saying is - is it right to test the placebo effect when we are talking about life and death of a child? With this kind of disease surely the effect of a placebo is likely to have minimal impact on the end result - death. It just seems a little 'wrong' to knowingly allow a group of children, who you have would have been better off 'risking it' with the drug, to die.

But they didn't know if the drug was effective or not. The aim of the study was to test this.

Well, my simple answer to that is "yes"

Death is almost always the end result of these cases in the end, it is about delaying it as long as possible. It is right that we undertake a scientifically rigourous investigation into the best methods of treatment, otherwise it is just educated guesswork.

Originally posted by Dug
But they didn't know if the drug was effective or not. The aim of the study was to test this.

Err... yes I understand that...!?

I was referring to the need to test the placebo effect... please re-read. :|

Originally posted by Yodameister
otherwise it is just educated guesswork.
If they monitored 100 children who just went about their normal lifes and then monitored 100 who were 'taken in' and given the drug - surely that would be more than just educated guesswork? I'm really questioning the need to have to test the effects of a placebo when there is already plenty of evidence to suggest what no treatment does. I know it's the basics of all testing, but we are talking about knowingly allowing children to die, just to be technically correct.

A quick google search has revealed that opinions differ on placebo effects from 0% (ie it doesn't exist) to 30%.

So it seems like the experts don't know any more than us......

Yoda, is that the effect of placebos on life/death illnesses? Or just an average for all kinds of tests? For a lot of minor tests it's entirely plausible that someone could 'think' themselves better, but that's a different kettle of fish compared to this experiment.

Originally posted by Geoff
If they monitored 100 children who just went about their normal lifes and then monitored 100 who were 'taken in' and given the drug - surely that would be more than just educated guesswork? I'm really questioning the need to have to test the effects of a placebo when there is already plenty of evidence to suggest what no treatment does. I know it's the basics of all testing, but we are talking about knowingly allowing children to die, just to be technically correct.

As you say, it is the basis of all testing. In hard headed scientific terms acne treatments should be treated in the same way as HIV.

I am put in mind of the early days of Science v Religion debates. Scientists were told it was all very well them looking at certain little things, but when it came to things like whether the Earth revolves around the Sun they should keep their noses out and leave it to theology.

It shows that the deaths of Black, African and Arab children continue to be acceptable losses ('collateral damage'), whether the deaths are caused by corporate negligence, corporate greed, drug testing, genocide, ethnic cleansing, UN sanctions or the War on Terror.

But maybe I'm a little biased, or perhaps just very upset.

Either way, I look forward to a fund-raising concert for the child victims of these drug trials almost as much I look forward to the responses of the Forums' apologists of Black / African / Middle East infanticide.

Many thanks

Originally posted by Yodameister
...but when it came to things like whether the Earth revolves around the Sun they should keep their noses out and leave it to theology.

Are you suggesting that it's worth checking the placebo effect on this kind of illness in case no treatment actually cures people? I think there is plenty of evidence to suggest that when someone gets has this kind of disease, it's massively unlikely that no treatment will cure them! We are talking about HIV/Aids here, not a headache (which could foreseeably cure itself if someone was taking a dummy drug.) I struggle to see the relevance of your earth/sun argument.

Originally posted by Abdul
It shows that the deaths of Black, African and Arab children continue to be acceptable losses

Abdul, they aren't doing the experiments on 'black children' for the benefit of 'white' (or 'Western'?!) people - they are doing it to try and benefit the 'black' people themselves. Africa is set to be the biggest 'winner' of any effective cure/prevention of HIV/Aids. This is not a race issue - after all, many of the other drugs in use in Africa may well have been originally tested on 'white' people. So I'm not sure we need to take the thread down that route?

The idea of testing the placebo effect is so that you can tell HOW effective the drug is.

What you have to remember is that people given the "real" drug get the placebo benefit as well. To calculate the benefit you take effect of "real" drug minus effect of "dummy" drug.

I'm not really saying that I know that it is right to do it this way (because I don't have all the stats to back it up), just explaining the arguments for it.

Originally posted by Geoff
Abdul, they aren't doing the experiments on 'black children' for the benefit of 'white' (or 'Western'?!) people - they are doing it to try and benefit the 'black' people themselves. Africa is set to be the biggest 'winner' of any effective cure/prevention of HIV/Aids. This is not a race issue - after all, many of the other drugs in use in Africa may well have been originally tested on 'white' people. So I'm not sure we need to take the thread down that route?

Very well. I concede that my post is going off topic, although I do have some interesting tales of expired Western drugs finding their way back to third-world countries for distribution there...

sometimes applying a rigourous scientific method can look callous and uncaring, but in the end it is the right thing to do.

geoff

I was also quite amazed whilst listening to this story on the news, i completely agree with what u said about knowingly letting them die. it is obvious to me that if doctors wanted to try the drug they must have had an idea of the effect it caused.they could've just given a small group of children the drug, to see if the drug was successful and drawn a conclusion from that rather than as u said give them false hope of survival.

Originally posted by Cyclone
sometimes applying a rigourous scientific method can look callous and uncaring, but in the end it is the right thing to do.

Well said. Science is always fighting an uphill battle against ill informed prejudice. At least now they just are considered callous, and not hung drawn and quartered for blasphemy any more!

Yoda, you're getting close to repeating yourself ;)

Can someone give me a good reason for testing the placebo effect in this situation, when, as said earlier in this thread: a) with such a serious illness the effects of a placebo are going to be irrelevant - the person will die and b) the fact that they already have 1000s of children dying each day which clearly shows the effect of not using this drug. Rather than try and twist this in to a general "informed prejudice" vs "science" topic, can we please justify this case with some actual, specific reasoning - apart from "'cos this is how we always do it".

Originally posted by Geoff
Yoda, you're getting close to repeating yourself ;)

Can someone give me a good reason for testing the placebo effect in this situation, when, as said earlier in this thread: a) with such a serious illness the effects of a placebo are going to be irrelevant - the person will die and b) the fact that they already have 1000s of children dying each day which clearly shows the effect of not using this drug. Rather than try and twist this in to a general "informed prejudice" vs "science" topic, can we please justify this case with some actual, specific reasoning - apart from "'cos this is how we always do it".

Because of just that... 'the placebo effect'. If you just gave the drug to one group and no drug at all to another, you don't know if the results are because of the drug, or just because the person is taking something which may cause them to fight the illness more effectively because the believe they are getting help. (The mind is a powerful drug too)

Without the placebo group, you have no way of knowing if the drug really works. Sad but true. They do this everywhere, not just in third world countries.

Snook, I appreciate you joining the thread - but if you read the entire thing you will see that I acknowledge the 'point' of the testing the placebo effect in general - I'm trying to move us on to be more specific about this case. We are talking about HIV/Aids here, which isn't something that you can't combat "because the believe they are getting help". Please re-read the entire thread :)

Sorry for repeating myself, but you are repeatedly asking a question that I thought I had answered.

My main argument is that the principles of testing drugs for serious conditions and for minor conditions is the same.

You seem to be doubting the existence of a placebo effect in the case of life threatening illnesses.

As I have said (sorry for repeating myself) I don't have the figure sto tell you how big the effect is in these cases (if it exists). I doubt there is anyone on here who is well enough qualified to answer you - but I'm certainly not, I was just explaining the principles, because you seemed to not be aware of what they were from your inital post.

I might have missed it from my original post, but I've made it clear many times since that I appreciate that testing the effect of a placebo is the traditional/standard way of testing all drugs.

But you still haven't answered my question: In this specific case there is a) lots of existing evidence to suggest what happens if the disease isn't treated and b) the disease is so serious (and established) that we know before the experiment starts, that the placebo will not have any meaningful influence on the patient's well being. Just because we always test the effects of placebos - doesn't mean it's always the right thing to do.

In this case, the scientists have knowingly put children's lives at risk for the sake of following protocol - even though they knew (from the nature of HIV/Aids and the fact people are already dying) the likely outcome of those on the placebo. It just seems a little 'cold' to defend the practice purely because 'we've always done it this way'.

Originally posted by Geoff
give me a good reason for testing the placebo effect in this situation, when, as said earlier in this thread: a) with such a serious illness the effects of a placebo are going to be irrelevant - the person will die and



Because the effects of a placebo are not irrelevant. Everyone will die eventually. The placebo group allows you to determine the physiological effectiveness of the drug over the psychological effect of being given a pill and being told it will help you.

Originally posted by Geoff

b) the fact that they already have 1000s of children dying each day which clearly shows the effect of not using this drug.

It's drug trial. 100s of children dying every day does NOT show the effect of not using this drug. It shows the effect of doing nothing. Consider the converse - the drug caused 40% of the group to die earlier than the 25% in the placebo group. Do think that would have made the news? Would you be glad you hadn't given everyone the drug?

Nomme

Originally posted by Geoff
But in most cases, when people sign up for drug testing, it's not a matter of life or death. What I'm saying is that giving those children a dummy drug gave them false hope - which is unnecessary as there are plenty of children dying every day from no treatment, which they could have used for their comparison.

Not unless the children in question were treated in as close to exactly the same way as your trial sample as possible baring the one variable of taking the antibiotic. Without this you can't prove that the drug has any efect as you are unsure whether the control group had been taking/not taking anything else which could account for the difference. The scientific process requires controlled conditions with only one (or as close to one as possible) varible being changed at a time.

Originally posted by Geoff
In this specific case there is a) lots of existing evidence to suggest what happens if the disease isn't treated and b) the disease is so serious (and established) that we know before the experiment starts, that the placebo will not have any meaningful influence on the patient's well being.

I agree it does seem a bit pointless but I think they have to do the tests in a certain way for the medical community and governments to accept that the tests were done properly.
I don't think could get away with "well, it seemed a bit pointless so we didn't do that test".

Originally posted by nomme
BThe placebo group allows you to determine the physiological effectiveness of the drug over the psychological effect of being given a pill and being told it will help you.
What is the benefit of determining the physicological effectiveness with a disease of this nature - where the patient will die no matter how hard they 'think' they won't. It's a pointless 'side' experiment, where the outcome (in this case) is known before they even start...

Placebo testing has got nothing to do with knowing what the results of no treatment is. So thats not really a SPECIFIC issue in relation to this case.

As to your second question, it looks to me like you are assuming that in this case there is no placebo effect. Now, it may be the case that placebo effect can be ignored in this case - but I can't answer that.

Originally posted by Yodameister
Now, it may be the case that placebo effect can be ignored in this case - but I can't answer that.
Of course you can - think of the nature of the disease we are talking about. Read my last post btw, added an 'edit' as you were posting :)

Originally posted by Geoff
If they monitored 100 children who just went about their normal lifes and then monitored 100 who were 'taken in' and given the drug - surely that would be more than just educated guesswork? I'm really questioning the need to have to test the effects of a placebo when there is already plenty of evidence to suggest what no treatment does. I know it's the basics of all testing, but we are talking about knowingly allowing children to die, just to be technically correct.

But surely if you monitor another 100 children going about their normal lives, you're letting them die just as much as the 100 you give the dummy drug to... I don't see the difference.

Originally posted by metalman
But surely if you monitor another 100 children going about their normal lives, you're letting them die just as much as the 100 you give the dummy drug to... I don't see the difference.

Glad some brought that up, as it was something that I threw in there :)

Is there a difference? One way you are making a conscious decision to conduct a placebo test with the knowledge it's impossible for the patient to survive with no treatment. On the other hand you are leaving the kids to enjoy themselves and make the most of their lives without any interferrence...

Originally posted by Geoff
What is the benefit of determining the physicological effectiveness with a disease of this nature - where the patient will die no matter how hard they 'think' they won't. It's a pointless 'side' experiment, where the outcome (in this case) is known before they even start...

It's not pointless. Your argument is based on the premise that the placebo effect in this case is negligible.
Other than waving your hands in the air can you back that up?

Where's Foxxx when you need her?

Nomme

Well for a start if you're a kid dying of AIDS in Zambia, I wouldn't have thought you're going to get a great deal of enjoyment out of life in the first place.

But in any case, I'm assuming that the most interference these kids would have suffered is taking a pill every day or two; I shouldn't think they'd do it if the control group had to be hooked up to a drip for ten hours a day or anything like that.

Originally posted by nomme
Your argument is based on the premise that the placebo effect in this case is negligible. Other than waving your hands in the air can you back that up?
Are you really asking me to prove that people can't treat HIV/Aids with just their minds? :confused:

If (as I expect ;) ) you are really asking me whether people can feel better (but still die) by taking a placebo - then I guess you're right - I can't say either way.

I don't know, this whole thing has been a bit of playing the devil's advocate. The thing that made me start this thread was the fact that someone would knowingly give a child the impression they might survive, when in reality they knew they would still die. I know I couldn't be the one handing out the placebos - but that's why I spend my days encouraging people to join in SF rather than being a scientist :P

Yes.

There are numerous cases on record of people recovering fully from "incurable" dieseases with no medical treatment.

Originally posted by Yodameister
Yes.

There are numerous cases on record of people recovering fully from "incurable" dieseases with no medical treatment.
Damn, was just 'bowing out' out of this (see last post) - but please link us up to stories of people that have fully cured themselves of HIV/Aids without medical treatment... I'm interested to see how they did it!

Originally posted by Geoff

Are you really asking me to prove that people can't treat HIV/Aids with just their minds?

What I was asking you was for evidence to back up your assertain that (in this case) giving people a placebo would have no affect on how long they lived.

Originally posted by Geoff
If (as I expect ;) ) you are really asking me whether people can feel better (but still die) by taking a placebo - then I guess you're right - I can't say either way.



And hence the need for a a placebo group.
Pharmacutical companys doing human drug trials cannot go to market without substantial scientific evidence.
"I don't know" won't cut it!

Nomme

Originally posted by Geoff
Snook, I appreciate you joining the thread - but if you read the entire thing you will see that I acknowledge the 'point' of the testing the placebo effect in general - I'm trying to move us on to be more specific about this case. We are talking about HIV/Aids here, which isn't something that you can't combat "because the believe they are getting help". Please re-read the entire thread :)

I did read the whole thing, I was relating it to this story. It would be ignorant to think that the power of the mind cannot have an effect on even things like HIV and Cancer. They still have to account for the fact that positive mental thinking can prolong the life of even the terminally ill.

To clarify...

Originally posted by Geoff
Are you really asking me to prove that people can't treat HIV/Aids with just their minds? :confused:

It's not HIV/AIDS that is being treated with this drug. It is the "secondary complications and infections". Such symptoms may come under the category of those that could be influenced by the placebo effect.

.. and therefore...
Originally posted by Geoff
The thing that made me start this thread was the fact that someone would knowingly give a child the impression they might survive, when in reality they knew they would still die.
... is innacurate. No one would have been given the impression they were going to 'survive' (ie be cured). They are all still going to die.

Originally posted by Geoff
I know I couldn't be the one handing out the placebos...


Even if the work you were involved in might potentially result in the kind of benefits that this test has produced?

I know next to nothing about medical trials. However I refuse to believe that the use of the placebo control test is not absolutely necessary for the results of the test.

Do you honestly believe that the moral issues you have brought up haven't been considered and agonised over by those involved?