Drug Trials

[TinyGang]

\link{http://news.bbc.co.uk/1/hi/health/4808614.stm\This} is quite I suppose being a guinea pig will always carry an element of risk, but even so, poor men..

KS, it takes aroung 14 years to get from discovering a drug to getting it to market. For most of that time it is tested on animals, tissue cultures etc.

Then it is tested on small numbers of healthy volenteers. these people are extensivly monitored, hear, lung, liver kidney function, blood work etc.

If that is OK then they test the drug in sick volenteers....in small numbers.

Then they move on to larger clinical trials.

Only if all of that is OK will a provisional licence be granted. In the first year of a new drug being on the market it will be flagged up with a black triangle. During this time all side effects have to be reported.

10 years aho it cost £100,000,000 to get a drug to market. Now it is arounf £1000,000,000

Nor had I until that moment, but I bet they have some kind of get out clause in there, like Acts of God on holidays and so on.

Tamum, they will have signed every disclaimer that the lawyers could think of

Was that though them not using sterile needles?
I can't think of any other way they could have got a viral infection in a drug trial.

That would have gone against basic good practice, and would have falled foul of basic standards of care. I can see why the companty had to pay out.....a dreadful lapse in standards and neglegent behaviour

But if an unknown drug acts in an unexpected way, I doubth they will have much of a chnace, since they would have signed a disclaimer

Sober now, I would imagine that you would have taken part in a Stage 3 clinical trial. By that time there is a reasonable amount of info on the drug....and you are right, if we don't take part, then no new drugs will be found

Yes, Fist the healthy volenteer, then small numbers of sick volenteers, then the larget stage three trials, then the post licence survailence. This would have been the first stage of human work. And it is done to check safelty before the drug is tested on sick people IYSWIM

This is just horrific and I really feel for those poor men and their families.

Martianbishop - it's really interesting reading what you have to say you are ovbiously very knowledgeable on the subject.

At our work we are following it with interest as we organise Investigator Meetings for clinical trials and work very closley with steering groups and CRA's. But I agree that it is such a heavily regulated industry that I'm pretty certain procedures will have been followed and that it is an very unfortunate and very rare incident.

saw a man on tv this morning who works for one of these testing companies saying that since the news report about these men, enquiries from people offering to be used as guinea pigs has increased tenfold. Apparently not many people were aware that you get approx 2k for doing these trials. Bizarre!!!

it's terrible. I know of someone who has done trials in the past, thankfully with no ill effects.

I heard this morning that more people signed up yesterday than normal to do this as perhaps they didn't realise before that you get paid so thankfully it doesn't seem to have put poeple off.

x post tiredemma

Unsurprisingly this has been a hot topic of converstaion in my lab, and the consensus seems to be that though it's possible it was an actual 'human error' mistake, it probably is a genuine severe adverse reaction.

The trouble is, the drug is a 'humanised' antibody designed to modulate the immune system, and so really it's species-specific. This means however hard you test it in anything other than humans (tissue culture, animal models etc), you won't know what will happen until it's actually put into people.

I hope the men recover, their families get the support they need, no-one gets too litigious, and healthy people keep volunteering for trials!
(Luckily we've done our big recruiting drive already, or our trial would be in real trouble.)

Bloody hell, there must be some really desperate people out there. I can understand being willing to participate out of altruism, but not for money. To lose your faculties and health for the sake of the good of the human race, is one thing, but to lose them for the sake of a couple of thousand quid, is quite another. The man in the follow on article (\link{http://news.bbc.co.uk/1/hi/england/london/4809322.stm\here}) was quite amazing.

Mrs Badger - what is your job if you don't mind me asking

I'm a research assistant in an academic lab. Currently in devlopment/preclinical testing, have recruited volunteers to get baseline measurements for the assays we're using.
I'm not on the clinical frontline but am one of the backroom boys designing/running the assays.

What do you do? Are you in the industry or just facilitating IYSWIM?

We are an event managemnt company specialising in the Pharma industry and Investigator Meetings. Our 2 main clients are 2 big pharma companies and we also work for many clinical research companies.

ah, the fun side of the business (more free biscuits please!)

Yes

feel sorry for the men
but that is the risk they took

And for many clinical trials the subjects are testing a fairly 'known' compound, possibly in a new preparation.

I used to work for Boots Pharma. I had friends who would get a few hundrad pounds for trying a new preparation of, say, Ibuprofen. Fairly safe and just involved them giving blood samples etc.

Not all drug testing is as high risk as this.

I used to work in drug safety monitoring, and we had to report all the adverse effects in a clinical trial to the CSM. It was all very well regulated

When I was a student I came very close to being a guinea pig. I gave blood for money at the clinic which paid about £20 which as a student in the late 80s was a lot. I was then asked if I would take part in a study which involved 5 days in the clinic and they would pay me £1200. If I had not had an exam shortly afterwards I would have done it as I had a whopping overdraft and it would have cleared it. At that age I did not really think about the consequences. I do feel that if we lost all guinea pigs less drugs would be available and then the drug companies would be able to charge more for them. This is the first high profile case in all these years of doing it. Unfortunately, these men could have been involved in a car crash or a climbing accident. I do feel desperately sorry for these families but these tests are vital and we do need them to continue. We can only thank the men for being so brave and hope they get better.