Drug trials

[laurence2]

Six men are in intensive care after taking part in clinical drug trials, They Volunteered to take part in testing an Anti-inflamatory drug.

The men suffered multiple organ failure in which two are said to be critically ill.

Apparently {parexel} have said they have followed the recommended guidelines, and an investigation is taking place.

My question is, does this strenghen the case to test animals or is this the chance you take when you volunteer for these type of trials, bearing in mind you do get paid.

From what i gather the majority of volunteers seem to be students, i assume this is the case to make ends meet.

Ps, i'm not saying for one moment that testing on animals is the right way, but what is the way forward in your view.

[Lollyhoney]

I always thought that in any drug trials that they were tested on animals first, and human testing was the next stage. I could be wrong though!

[Whickerman]

Animals and humans are different. Surely this is a fact? If so, then trials on animals can never fully show if a substance will have a good or bad effect on people. We'll simply never know if we've missed the cure for cancer simply because it had a bad effect on a guinea pig.

[maxi29]

If anything, I'd have thought that this tragic event would weaken the case for animal testing. These drugs had been extensively tested on animals and they still had a deleterious effect on humans - it makes one wonder whether animal trials are a useful guide.

[undercovers]

these drugs will have already gone through the animal testing stage before they can be tested on humans - sad state of affairs for them and i hope they survive without any long term damage. I don't feel that cases like this say anything for or against animal testing... just a very sad story... though i think you could discuss whether it is appropriate to offer people 2000 pounds to risk their lives, something only the poor in society would consider doing, maybe this case will stop people volunteering for these experiments for a while (but i doubt it - the drug companies will simply put the fee up to a level to more tempting to people of a gambling nature)

[kazza12345]

i think it's too soon to make comment, after all, we do not know the facts. Someone in the lab may have made an error in dosing, the person administering may have read 100m/g intstead of 100 mcg, anything really

[Hgrove]

What I find is not fair is that vulnerable people, in this case hard up students, end up guinea pigs; if they did not need the money they would not take the risk. These are harsh decisions to have to make and I cannot be sure it really was a free choice by the students.

[kazza12345]

you are making big assumptions there anout "vulnerable people" hgrove. Would it make you worry for their free choice if it was just people who were too lazy to get a proper job, and wanted to get paid for doing practically sod all?

also, students may be hard up, but it is their choice to be students isnt it? they could just get a job instead? if they really felt their only option was human experimentation, and they were unhappy about this, and it was hugely distateful to them, then another alternative might have been to stop being a student.

My point is that we do not know the circumkstances (nor should we need to unless they were coerced) and it dosent make any difference to how sad and tragic this situation is

[4getmenot]

Hgrove if burglars or bank robbers wernt hard up they wouldn�t put themselves in risk of jail but do you feel sorry for them. It�s a risk that these people have taken. They�ve signed the papers to say that they will put something into their bodies that they don�t know what will do to them. It is very sad for their families and my thoughts are with them. But mice and rats don�t sign a piece of paper just think how they feel. But after saying that I think drugs should still be checked first on animals, we wouldn�t be anywhere near where we are now to treating cancer without the use of animals.

[Drusilla1S]

These drugs will have been tested on animals before the human trials began, so I don't think much will change there, but I assume the volunteers did not fully appreciate the dangers involved. That is not to say they were not informed. It's just another example of the 'it won't happen to me syndrome' that affects us all in certain situations.

No testing is ever safe. When human trials are carried out after much research and testing on animals, it is usually on young males. The results of such tests will not necessarily be reliable for women and in particular, young children.

Doctors have been very concerned about the reliance on young male volunteers in testing for a long time and more females need to be encouraged to participate, but safe dosages for children is always going to be a thorny issue because no one is going to advocate child testing in any circumstances.

Drug companies would have to pay much more money to entice me to get involved in such testing.

[asciwhite]

Hi all, some of us will go in for drug trials because we look for a cure, here is an example of the drug trial I was offered through the hospital. I'm glad I said no.

http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1307

[kick3m0n]

I used to work in contract research until I left to be a full time mum a couple of years ago. I can tell you that the testing carried out before the drug is given to humans is extensive and lengthy to say the least. It is only this extensive testing on animals that has prevented horrors such as thalidomide occurring again. Animal testing is not foolproof but it does give us the best indication possible of any adverse affects of a drug. No computer models or cell/tissue work could ever yield such reproducible results. To be honest, I'm not sure how such a severe reaction could have occurred, as drugs are tested on animals at a far higher relative dosage than these humans would have received. The safety margin has to be wide (ie 10 fold, 50 fold or 100 fold doses in animals is not uncommon) to give the greatest possible assurance of no adverse human reaction as well as an indication of what a potential overdose would be. My gut feeling is that something went wrong with either the production or administration of this drug that has led to this awful event. I'm going to watch this one with interest, as well as speaking to pals who still workin the industry, to see if they know which CROs tested this drug at the pre clinical (animal) stage.

As for people who volunteer for these trials..I know several, some are repeat volunteers. They are not paid a large amount but many (often students) do think of it as an easy way to make some money. However, all will be made aware of any and all risks involved, and thoroughly screened for suitability for the particular drug being tested. Such occurrences are very rare, hence our shock at hearing about this. There are thousands and thousands of volunteers testing drugs across the country every single day, yet only a tiny percentage will ever have any side affects at all and certainly not anything in any way serious.

[Haggisdj]

Should they try test them on sex offenders... discuss!

[kick3m0n]

no.

[morg_monster]

I am sure that if it doesn't turn out to be a dosing error, the anti-vivisectionists will cite this as evidence against animal testing, saying that this potentially lethal side effect was never picked up in the animal tests. However the fact that this has never been known to happen before, according to the head of the ABPI (asssociation of the british pharmaceutical industry), means that it is unlikely to change the opinion of 'the people who matter'.

This is a real freak occurence, and like kick3m0n, i'm interested to see how it pans out. I used to work in a CRO but now i'm in a non-commercial medical research organisation. Luckily for us we only do phase 3 trials with drugs which are already approved for use, looking at therapeutic strategies rather than just at the efficacy of the drugs.

I wouldn't feel too sorry for the students, either - since this has never happened before, how could they warn them, other than to tell them that in theory anything could happen. The researchers will be devastated, too, remember, we aren't automatons. (especially if it does turn out to be a dosing error... big trouble!)

Plus - ethics committees make sure that the amount of money given to testers is not too large so that it really sways their decisions. When you consider that in general for phase 1 trials, the testers have to stay in the unit 24 hours a day for a week or a fortnight, �150-200 a day is not quite as much as it first seems.

[asciwhite]

Hi morg_monster, slightly off the subject but asking of your opinion, what phase was the campeth drug trial at that I posted up? I'm fascinated by it all because they literally pulled it... and this other drug trial with the then 'healthy' students, is/was aiming for leukemia research?

[morg_monster]

That trial is a Phase 3 trial, because it included people who actually had the condition (MS) and also was a comparison between the new drug (campath) and the current standard treatment (Rebif). The main phases are:
pre-clinical: lab & animal testing
Phase 1: testing on very small number of healthy volunteers. Aim to establish safety
Phase 2: testing on people who have the condition, larger numbers. Aim to find a dose that is both safe and also works.
Phase 3: "randomised controlled trial" - the gold standard of drug testing. Compares the new drug to either best current treatment, or to placebo if there�s no current treatment. Drugs usually undergo several phase 3 trials, each recruiting in the 100s or 1000s.
Phase 4: after the drug has been approved, these are usually called 'post-marketing' trials or surveillance, and try to involve as many people as possible who are on the drug. Now suddenly tens or hundreds of thousands are taking the drug, so this is where really rare side effects are picked up, like Vioxx

When doctors/regulatory agencies decide what are 'acceptable' side effects, they have to take into account how bad the effects are and how many people get them, and how bad the condition is. In my job I look at cancer drugs where the side effects are horrific, but then so is the disease. Drugs from the same family as Vioxx are being tested in cancers, because they work, and the side effects are balanced by the severity of the disease. Sounds similar to Campath - while the side effects aren't acceptable for sufferers of MS, if you have leukemia, they may be. They will have to go back to Phase 2 or phase 1 for using Campath in MS patients, but it does look like it works though!
(in cancer the phase 1 trials are different - usually cancer chemotherapies are never tested on healthy individuals because of the awful side effects. presumably they didn't expect the side effects from this drug to be so bad!)

[morg_monster]

phew - sorry for long post - but i love my job and talking about it!

[Drisgirl]

I may be wrong morg and asci and I will stand corrected but was this not the drug (Campath) Jimmy Johnstone (who had MND) campaigned to be a guinea pig for.Unfortunately he died on monday but was told he had been accepted and felt he had won a battle to aid MS sufferers.I know both illnesses are different through personal family experience but what a brave man to volunteer-when he didnt have his troubles to seek-to perhaps help others.

I dont know how we can advance if we dont continue along the route we take - I agree with kazza there is a danger of a knee-jerk reaction and we dont want to retard the progress which has been made.

My thoughts go out to the 'volunteers' and their families.Without people like them I doubt half of us would be here.(Its just a pity it goes so radically wrong in a minute number)

[asciwhite]

Wow, thank you!!! morg_monster, it's so good when an expert in his field answers so well and... in laymans terms...working on cancer cures must be very satisfying and heres to a break through that cannot be refused on monetry terms....

[asciwhite]

hi Drisgirl, I didn't know that Jimmy Johnstone had campaigned to be one of the 'guinea pigs' for the Campath trial, but it kind of rings a bell now you come to mention it.

Bless him, MND is just awful, and he is at peace now...

Thoughts are with the students, that they pull through without any lasting damage and that their families get strength from each other.

Brave lads...