[Closed] French Medical Drug Trials, have you, would you ?

Not a chance

I don't even like taking paracetamol

Poor guys.

I'd given it some consideration as a student but the thought of this happening has always put me off. For me, the risk/remuneration just isn't worth it.

I volunteered at university but got a bug which excluded me from it. They do pay extremely well and the overwhelming, overwhelming majority are completely safe. I know a few people who volunteered for the more serious ones and mostly they just involved lying in bed for 72 hours being bored witless.

I think the one I volunteered for turned out to involve having medicated plasters stuck to various bits of your body for a few days whilst going about your normal life and paid a few hundred quid.

There've been other disasters - see Northwick Park / Tegenero

@sandwich & @lemony how much where they offering ? Thanks for link @scaredy, I just read about failed uk tests in 2006 wasn't aware before

I had mates at Uni who used to have free dental work done by students but was never aware of drug trials.

I wouldn't do it for money if healthy but I would think about experimental drugs if sick.

It's a long process before it reaches this stage. Tragic stuff. I'd probably do it yes.

Is animal testing compulsory / likely in this sort of case ?

the people i know who have done it have been pretty desperate and prone to drug experimentation in any event , probably a function of the people i meet rather than those who sign up. No way would i do that unless i was at the end of my life and convinced it would be for the greater good or may give me a fully functioning life extension .

It will have been tested in animals first. No way the regulators allow human trials before animal testing.

What went wrong is all speculation at the moment. Phase 1 trials start with very low doses and increase slowly with the explicit purpose (among others) to find the toxicity limit. With Teganaro the issue was, if I remember right, mistakes were made in translating toxicity dose values from mouse models to humans and the first dose given to humans were way too high.

Tragedy whatever happened.

J.

I did a couple at uni, paid very well and was v interesting to be a part of! I did a research job after uni with glaxosmithkline and the drugs go through a lot of testing before human stage, and if there is a whiff of a problem in the animal stage they get dropped! I am interested to know what the complications were! Although terrible it will give a useful insight into animal/human model differences!

I was made fully aware of potential risks before I started the trials and had to give lots of medical info before they would let me take part.

Nah, not for me.

I too did some Dental trials, my old friend who used to own the yacht we raced was a teacher in Dental Max Fax surgery. When I ended up with a broken jaw and no front teeth from a Chinese Gybe during the Middle Sea race, aboard his yacht, he offered to fix me up.
That's as far as I'd ever go in to it.

It's truly staggering the impact of this particular instance of trials, to offer up your body for a few quid without any recourse or understanding to the complicated side effects, is quite beyond my comprehension.

It's truly staggering the impact of this particular instance of trials, to offer up your body for a few quid without any recourse or understanding to the complicated side effects, is quite beyond my comprehension.

@phil going to ask the same question, whats well paid mean exactly ? I am guessing the numbers might not be that high if you are not on a student budget / skint ?

Yeah did a couple. One was anti emetics for cancer treatment, done through QinetiQ so there were a couple of air sick gas jet pilots there too. Paid well involved being spun in a dark box until you felt the bile rise. Got to have a go in the big centrifuge at queens gate Farnborough, think its in a bond film.

Did a second that paid £2k for three nights in 2000. Lots of memory and hand eye coordination stuff.

Was offered a third which was at Centre for Human Sciences. It involved running at a steady pace on treadmill into a cold mist. Test was to see how various substances affected the time you could run for. There were various amphetamines in the possible substances and my then employer wasn't willing to let me take part. I wasn't too keen when they said id be running with an internal temp probe.

I haven't done one. But have been involved in running trials.
The last one was just after the tegenero **** up.
The pay is very good (talking 1000's) but you have to not take any other drugs unless specifically allowed and also the payments are frequently dependent on attending a certain number of follow up clinics.

Things like this will happen sadly either through mistakes or simply that they truly don't know exactly how a human will respond.
The thing is this is one case in maybe 20000 trials since the tegenero one. I am probably grossly underestimating that number as there are loads going on.
Yes it can happen but that's why full informed consent is required and the pay is that good

@onehundred - thanks and agreed re running with the temp probe in 😯

It's how "I think" but is seems to me the drug companies should provide/buy insurance against side effects, that would be factored in to the amonts paid. If the insurace is really expensive then there is a message in there.

IIRC after the last disaster there was actually a spike in applications because as pointed out, the odds of if going wrong are so low.

There will be some large payouts after this one. Not sure on the exact size but the companies will have insurance and if there has been a screw up then the fines will be large too. There is also the risk that the operating company will lose its GCP license too. Having been through a fair bit of reg training the total emphasis on protecting the patient is the single most important thing.

There will be some large payouts after this one.

Not necessarily. In the UK disaster, the trial was conducted by a small trials company, not the pharma who developed the drug. The trails company folded after the accident and there was nothing left to sue....

Tegenero went bankrupt. Parexel who ran the trial are still going and i suspect that both would have insurance. the trial organiser assume responsibility of certain sections of risk.

The real shame about the Parexel / Tegenero thing was it was already known that the drug was dangerous, just the data hadn't been published by a different company that had already tried that type of drug. Detailed in Bad Pharma by Ben Goldacre.

One if the issues is that you get people doing clinical trials for a living so end up with a cocktail of drugs in their system... The money is good and if you go through 1 with no effects you will probably sign up for another. All you do is fill in the form saying you are healthy and are not taking any medication etc. They can't did through you history like MI5 to see what's going on...

Sadly this stuff happens and is part of the process of bringing medication to market. Our reliance on medicines is disturbing but we have come a very long way very quickly (last 100 years) but now could be going back thanks to Chinese pigs...

One of the big issues is the lack of transparency on trial data. Not that it would have stopped that issue sadly.
All trials is a good site to have a look at the philosophy behind it

No, no, even when I was flat broke. I'd turn to crime first.

I design them for a living. I have never designed a trial I would not be happy to take part in myself.

I'd be interested to read the Clinical Investigators Brochure, a regulatory document that reports what is known at the present Phase of development about the molecule. According to [url= https://en.wikipedia.org/wiki/Fatty_acid_amide_hydrolase ]wikipaedia[/url], the drug was tested on chimpanzees. This in itself is extremely unusual (and now illegal in the EU), implying to me that they must have felt there was some very specific target toxicity that would not manifest itself in other preclinical species. Other FAAH inhibitors have already been tested, but one can never rule out non-specific off-target effects from a specific molecule.

The real shame about the Parexel / Tegenero thing was it was already known that the drug was dangerous

Most people will be unaware that TGN1412 has been back in [url= http://www.ncbi.nlm.nih.gov/pubmed/24374661 ]healthy subjects[/url] and rheumatoid arthritis patients at "pharmacologically appropriate" doses, which should have been give from the begining, and not shown the cytokine response seen previously. [url= https://en.wikipedia.org/wiki/The_dose_makes_the_poison ]sola dosis facit venenum[/url]

The study protocol will be available to the public. I would be interested to see the trial design. Maybe they escalated the doses too quickly?

@TiRed, fascinating thank you

I have never designed a trial I would not be happy to take part in myself.

Bet you haven't though.

I used to work for one of the big drug companies in the research dept. There were drug trials offered which as a student were pretty attractive.

All the guys doing the research work I knew said they'd never do it. Everyone has unique chemistry to some degree and while the overall odds may be good, the impact is massive.

Didn't realise that Parexel were involved in that case. Big office near us, I've often been tempted to pop in and enquire.

I wouldn't volunteer for a clinical trial because I get bad side effects from every single medication I've ever taken!

Bet you haven't though.

In days past, companies would allow their employees to participate in their own trials, largely because the Phase 1 units were on site. Most Phase 1 units are now independently run Contract Research Organisations. Parexel Northwick Park used to be the GlaxoWellcome Phase 1 unit, for example.

Can't say for who or where but I have seen the SAE (Serious Adverse Events) statistics across several hundred R&D pharma trials. More chance of winning the lottery than something going seriously bad. Mostly nausea or rashes from what I saw.

I don't do the lottery because of the chances of winning.
I don't do drug trials because of the chances of losing.

im not sure you could sue for damages? You sign a no doubt huge amount of paperwork to test an untested drug for side effects and accept the risks there of - if there wasn't an element of danger it wouldn't pay a coupe of grand for a few days work.

I signed up to trail some migraine meds a few years ago, they didn't say what it paid until you were accepted by it was in the thousands, they deselected me, but didn't say way - I'd bet it was a physiological issue ha ha

I'd do one, indeed I'm on the mailing list for one of the companies (quintiles?), only haven't because the timing isn't great if you've got a full time job - usually need 14 days plus a few out patient visits, at the point you're taking time off work it's not really worthwhile.

I have however taken part in another trial instead.

Me too, a production car trial, an MTB trial, trials on the blood sugar levels and insulin response of athletes.

Specifically did the trial you took part involve taking drugs?

Specifically did the trial you took part involve taking drugs

Well since you are being pedantic, yes it did. It seems only reasonable to gain first hand knowledge and experience of what one would expect other participants to do. I did not get paid either.

I've done medical trials but not drugs ones. Not for any particular reason I suppose, I'd consider it but never been asked.

No. Never. Not me.

I donate blood and platelet only.

There are many people in this world who want the money so they can take the risk.

edit: Please don't experiment on the animals. Human, yes.

As a medical professional you were well placed to assess the risk of the trial you were involved in TiRed. The students employed don't have a clue how risky what they are doing is.

"Reports that the drug is a [b]cannabis[/b]-based painkiller have been denied by the health ministry." BBC

Who say it's harmless again?

I'd take a wild guess here and say they are told of the risks Edukator. You really do go out of your way to find an argument.

I know they are as I've prescribed trial drugs at the very later said stages and you have to inform them of any risks and complications.

"Reports that the drug is a cannabis-based painkiller [b]have been denied by the health ministry[/b]." BBC

🙄

whatnobeer - Member

"Reports that the drug is a cannabis-based painkiller have been denied by the health ministry." BBC

🙄

I have denied the denier ... 😛

I would do it. I'm not the only one who thinks there would be a chance of gaining super powers (we all think it)

Maybe i would gain the power to sleep through the night without having to get up and tinkle 😳

Like Drew Barrymore?

I find the whole thing fascinating - especially with the current fad of recreational use of unknown substances - claimed Research Chemicals.

A simple mix up with labeling a few years back led to a few deaths

http://www.bluelight.org/vb/threads/570700-2C-E-Death-in-Oklahoma-Mislabeled-Bromo-Dragonfly

That is under un-controlled conditions, so they chances must be significantly higher than in medical trials.

Will we be told why the brain damage occurred?

Quirrel - they will have to fully investigate what happened and document it in the clinical study report. Study reports are made available for the public to access these days.

Study reports are made available for the public to access these days.

Not always. Trials tend to be always posted on [url= https://clinicaltrials.gov/ct2/home ]clinicaltrials.gov[/url] because journals will not accept results for publication otherwise. [url= http://www.gsk-clinicalstudyregister.com/ ]Some companies[/url] publish a lot and most now publish Clinical Study Report Summaries, but not the full reports. In this instance, however, just as post-TGN1412, I expect all regulatory documentation will be made available to the public. I'll be reviewing it closely.

^ I will keep an eye out for it.

I have followed the rise of RC's online with great interest, particularly how people are dosing, doing allergy tests and the active dosage levels of some of these chemicals.

Some of the comments I have read on drugs-forums and bluelight are properly scary with people talking about hands going blue from vasoconstriction for days afterwards and 'eyeballing' doses, even when they active dose is thought to be at the microgram level.

Having last worked in the UK at the tailend of the the mephedrone craze, and with the 'spice' synthetic cannibanoids starting to make inroads into school, and the kids at school looking for similar chemicals. I am therefore keen to read a report where it has all gone wrong under strict controls, with how much was given, and what they think it was that went wrong.

The people writing on those forums are the sort of kids I used to teach, and some of the justification of their methods, measurements etc makes me wring my hands. I'm not adverse to a dabble, never was when I was younger, but then I was never prepared to risk losing my fingers or toes to gangrene either, just to see.

I thought that with the Clinical Trial Transparency Policy, that all study reports will be made public. It takes a while for them to appear though.

I also am involved tangentially in this sort of thing, professionally. There really are an awful lot of rules about how these studies are run. Which is partly why so few go wrong. That doesn't mean that it's no big deal when they do, but some people seem to have the idea that reckless people in the pharma industry just do whatever they like, without telling the human guinea pigs what it is they're doing to them. It's never going to be perfect, but it's not like that.

"Reports that the drug is a cannabis-based painkiller have been denied by the health ministry." BBC

The press jumped on the word cannabinoid and assumed cannabis. The two words are related as THC in cannabis affects the cannabinoid receptors in the brain, but in this case this trial drug is to quote "an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme that breaks down so-called endocannabinoids in the brain. FAAH inhibitors have been proposed as a possible treatment against chronic pain."

http://www.sciencemag.org/news/2016/01/more-details-emerge-fateful-french-drug-trial

Recreational drugs have many connections to pain killers. Aside from cannabinoid receptors we also have opioid receptors and some of the strongest and most effective pain killers are opiates that bind to these. Opiates are derived from opium or a synthetic variant of. That's why in Victorian times people took opium for pain.

I've done one, and applied for a few others but pulled out due to work / time constraints. Was used for a trial for asthma drugs, and their effects as a non-asthmatic control. Had to have my lungs x-rayed (or the equivalent, im not entirely sure!) after taking the drugs at various times. The upshot was I got paid fairly well, had to do some interesting lung function tests (in one doctors words, you have massive lungs!) and I've come out the other side without growing another head / lung / willy.
I'd do another one if the conditions were right, and I needed the money...