#713689 - 16/03/06 09:15 PM
Six Men In Hospital After Drug Trial
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Gromit's Humble Squire
Registered: 02/02/05
Loc: Brisbane, Australia
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http://uk.news.yahoo.com/15032006/140/six-men-hospital-drug-trial.html
Just watched this report on the news. Apparently each of the men were paid $5000 (around 2000 quid?) to be injected with this prototype anti-inflammatory drug.
Watched one of the victim's distressed Australian (probably why it made the news here) girlfriend describe the incident, after being told he was critical and could die. Was pretty hard-hitting.
Should the victim have been prepared for it, or should the pharmaceutical company have taken measures to ensure it didn't get this bad (does that defeat the purpose of clinical trials?)
What say you?
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#713690 - 16/03/06 09:33 PM
Re: Six Men In Hospital After Drug Trial
[Re: Ry]
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member
Registered: 29/05/05
Loc: Manchester
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Hmm, I take part in clinical trials without getting paid - this kind if reaction is extremely rare - the worse i've ever had is a migraine and a arm spurting blood (cos the nurse didn't hold the pad on long enough after the cannular had been removed)........
Surely there should hae been some kind of computer simulation done first?
_________________________
'If your deeds shouldn't be known, perhaps they shouldn't be done, if your words shouldn't be shared, perhaps they shouldn't be spoken. Act with attention, for all your acts have consequences" (Rabbi Judah HaNassi)
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#713691 - 16/03/06 10:01 PM
Re: Six Men In Hospital After Drug Trial
[Re: Gremlin_Lou]
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had her carpal tunnel surgery already thanks v much
Registered: 27/01/05
Loc: Edinburgh
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First of all the drug gets tested in other "systems". One of the first is a test on bacteria to see if it can cause mutations and therefore cancer. There is also computer modelling. Then there's the animal testing, which takes about 4 years. If all of these prove "safe" the substance can enter clinical trials.
Usually between animals and humans the "safe" dose is taken down quite a bit to allow for humans reacting differently, and the fact that ultimately the substance will be applied to sick people or even kids, who may be more sensitive to it.
The first phase of the clinical trial is to give the drug to healthy people to see effects that are only due to the drug, not any sickness the patients might have and how that interacts with the drug. This is where this drug failed.
I don't know if they've taken all the standard precautions, but there always is the risk that a drug may affect humans in a completely different way than computer-generated systems or animals, even though such a rapid and bad reaction as seen here is rare. There have been other cases though, for example when a drug proved to harm the foetus (contargan-babies).
So Ry, you're right, it does defeat the purpose of clinical trials. You never know what will happen until you actually expose humans to it. And participants in clinical trials are aware of that - if they're not there was either a big mistake by the company for not letting them read and sign the forms or they're a bit ignorant.
I feel incredibly sorry for these people who might have to lose their lives for trying to make money by helping others.
And before this turns into a "do we need new antiinflammatory drugs" debate, the answer is the same as usual - if you don't care about all the people suffering from inflammatory diseases or think this is a good way to reduce the world population we don't. But I think we do.
link about clinical trials:
http://www.centerwatch.com/patient/backgrnd.html
Edited by Birgit (16/03/06 11:16 PM)
_________________________
"vices are like genitals - most are ugly to behold, and yet we find that our own are dear to us."
(G.W. Dahlquist)
Owner of Dragosani's left half
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#713692 - 16/03/06 11:41 PM
Re: Six Men In Hospital After Drug Trial
[Re: Birgit]
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big and good and broken
Registered: 29/08/02
Loc: lunn dunn, yoo kay
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the drug was being tested for indications for leukemia, rheumatoid arthritis and multiple sclerosis i believe.
it sucks, but this is what trials are for and that is why they pay so much money to the 'volunteers'.
having siad that, it is an extremely rare occurrance and hopefully it will not have an adverse affect on the medical testing world.
moreover, i hope the guys in intensive care manage to recover.
cole. x
_________________________
"i see you at 'dis cafe.
i come to 'dis cafe quite a lot myself.
they do porridge."
- tim westwood
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#713693 - 17/03/06 12:19 AM
Re: Six Men In Hospital After Drug Trial
[Re: coleman]
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remembers when it was all fields round here
Registered: 27/02/03
Loc: in the works... somewhere...
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Written by: coleman
having siad that, it is an extremely rare occurrance and hopefully it will not have an adverse affect on the medical testing world.
It will be interesting to observe exactly what effect this does have on medical testing.
People with chronic conditions are often keen to try anything which may alleviate their suffering even if only mildly. Drug companies and medical professionals already exploit this need in the latter stages of drug trials by under-emphasizing the probability of known and unknown side effects and often not mentioning some at all. I won't be surprised if the number of "healthy" volunteers declines rapidly after this news and I hope that this doesn't result in attempts to introduce patients into trials earlier.
I don't know what the alterative is - which is especially frustrating as I'm not an advocate of animal testing - but as these volunteers fell severely ill within seconds of taking TGN1412, I'd be inclined to think that either the previous testing is not accurate or extensive enough or that someone in that chain has made a very big mistake 
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#713695 - 17/03/06 12:53 AM
Re: Six Men In Hospital After Drug Trial
[Re: Spanner]
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had her carpal tunnel surgery already thanks v much
Registered: 27/01/05
Loc: Edinburgh
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It doesn't have to be a mistake... I'm not saying there was none, but a tiny minute difference in protein structure between animal and human can cause a huge difference in the response.
I wonder if some of those who advocated testing on humans in the animal testing thread have changed their mind over this? (they should, unless they advocate torture...)
_________________________
"vices are like genitals - most are ugly to behold, and yet we find that our own are dear to us."
(G.W. Dahlquist)
Owner of Dragosani's left half
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#713696 - 17/03/06 01:09 AM
Re: Six Men In Hospital After Drug Trial
[Re: Birgit]
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Scientist of Fortune
Registered: 15/04/05
Loc: Edinburgh
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Surely this is exactly why we need human trials.
Six men may die from this, but the alternative would have been the drug being put out on market and potentially killing many more.
_________________________
According to Heisenberg's Uncertainty Principle of Quantum Dynamics, we may already be making love right now...
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#713699 - 17/03/06 02:29 AM
Re: Six Men In Hospital After Drug Trial
[Re: jeff(fake)]
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NYC
Registered: 26/08/01
Loc: NYC, NY, USA
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Written by: jeff(fake)
Surely this is exactly why we need human trials.
Six men may die from this, but the alternative would have been the drug being put out on market and potentially killing many more.
Again with the common sense and logic? Will you never stop? 
There are two extremes in getting a drug ready for market, testing too fast and not testing fast enough.
Rushing a drug to market might result in situations like this.
Keeping a drug from the public for too many tests will result in people dying because of the lack of access to new medications.
The happy medium is NOT when nobody dies, but when the damage of moving forward is offset by the damage by not moving forward.
If there are paticulars about this case that are problematic, they should be addressed. This should certainly not change the general manner in which smaller group/higher risk testing is done.
Anyone in a test group like this should certainly have been told about the possibility of death and accepted that risk.
It's funny how, even on HoP, people will say "It's stupid how there are too many warnings everywhere" and then when people start dying people say "There should have been more warnings!"
A freind of mine said it best "Everybody hates the pharmicutical industry until they need it."
And is there an actual arguement AGAINST clinical testing? What would that arguement even be?!
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#713700 - 17/03/06 02:38 AM
Re: Six Men In Hospital After Drug Trial
[Re: Asena]
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hehe, 'Member' huhuh
Registered: 13/07/05
Loc: Behind you. With Jam
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Definitely, it's just a matter of making it clear to the person that adverse affects IS a hazard of the program and that they are there of their free will. It may turn people off, it's just a matter of how desperate/altruistic a person will be.
One thing that has always troubled me is the refusal to take on volunteers who have 'dabbled' with drugs.
Not to advocate or validate drug use, but more often than not someone who uses illegal drugs WILL require the need for the legal pharmecuticals which are being tested. If the legal works without complications on a 100% subject but has seriously adverse affects on someone with illegals in their system.
I mean we don't condone underage sex but still give out free condoms JUST IN CASE. IF their policy is avoid encouraging or advocating drug abuse, could they not reach a compromise? Like say make it clear that they will be paid considerably less if illegals are found in their system...
_________________________
"I used to want to change the world, now I just wanna leave the room with a little dignity..." - Lotus Weinstock
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#713701 - 17/03/06 03:02 AM
Re: Six Men In Hospital After Drug Trial
[Re: Neon_Shaolin]
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had her carpal tunnel surgery already thanks v much
Registered: 27/01/05
Loc: Edinburgh
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I can't see a "there should have been more warnings" here, just questions from Ry (who, as far as I know, didn't previously complain about warnings).
Shaolin, it would've been part of the agreements that people sign to not have legal or illegal drugs a certain period before testing starts.
_________________________
"vices are like genitals - most are ugly to behold, and yet we find that our own are dear to us."
(G.W. Dahlquist)
Owner of Dragosani's left half
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#713702 - 17/03/06 05:10 AM
Re: Six Men In Hospital After Drug Trial
[Re: Birgit]
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Gromit's Humble Squire
Registered: 02/02/05
Loc: Brisbane, Australia
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Birgit: Your earlier post is good insight into process and procedure. Works as a basic primer for someone very non-clinically minded like myself. Much appreciated.
Similar to what Spanner's said- I'm inclined to think that re this drug, they could have been jumping testing stages a bit too eagerly. But then (and not isolated to the pharmaceutical industry) having the first jump at something new, unique, and in demand translates to very happy shareholders.
NYC: Ironically, the news report I watched pointed out that there was documentation which the volunteers signed which suggested that such trials were largely 'safe'. Which is another thing which made the story.
Regarding the pharmaceutical industry though, if you think about it, it's a pretty good balance really, if one had to pick a side. If profit didn't guide research and medical advancement, what would? As a lot of people here seem to have pointed out, despite anything bad anyone can say about it, they *are* providing the medicine which has invariably increased human lifespan and quality of life (compare say, 20-50 years ago). Well, until someone actually proves they've hidden the already discovered cure to the common cold because cold medicine's a billion dollar industry in itself..
Shaolin: Regarding refusal to take on volunteers who've dabbled in drugs- why should it trouble you? In other terminology, why would a techie prefer to do a format of a drive before installing an operating system, instead of just installing it over the old format? What if traces of the recreational drug in the volunteer interfered with the drug or clinical method being tested?
Furthermore, in regard to your other statement, re the possibility of being fatal to drug users while not to non-drug users, let me ask you this. You're a pharmaceutical company. I've just suggested to you doing a major trial for this wonderful new drug to solve a particular serious heart condition, and after I've somehow managed to convince you it's got a good chance of success, now I'm asking for more money to set up separate trials to save people with that particular serious heart condition who just happen to be recreational users of MDMA (Ecstasy), GHB, Rohypnol, ketamine, methamphetamine, and LSD. What would you tell me?
Underage sex and contraceptives is a different kettle of fish. They (governments, organisations, educators) give out condoms to everyone, not just underaged people. It doesn't solve but is a means to tackle a very major social as well as economic problem. You really can't compare the two issues at such a surface level.
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#713705 - 17/03/06 05:41 AM
Re: Six Men In Hospital After Drug Trial
[Re: jeff(fake)]
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hehe, 'Member' huhuh
Registered: 13/07/05
Loc: Behind you. With Jam
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It troubles me because of it being such a muddy, non black/white subject.
I mean part of me does think 'well if they reacted badly to the medication because they have recreational drugs in their system - they made their bed...etc and its a consequence they'd gonna have to accept'
But part of the argument does have its foundations in whether we accept (regarding the teen sex thing) what could be an inevitability. I'm not saying that we should provide special funding to manufacture pharmicuticals that cater especially for drug users but if adverse affects are to be found then warnings could be printed on the boxes.
So in answer to your question if it was a question of funding, you'd be right in saying 'why should we dedicate our studies to helping those who choose to damage themselves?'
I'm just troubled as to what to do if the person was not damaged by the illegal drug itself, but if mixing it with the pharmecutical would prove fatal. Do we leave them to die? or do we give them as chance to live and perhaps clean themselves up?
_________________________
"I used to want to change the world, now I just wanna leave the room with a little dignity..." - Lotus Weinstock
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#713708 - 17/03/06 06:01 AM
Re: Six Men In Hospital After Drug Trial
[Re: Ry]
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What a Bummer
Registered: 22/08/05
Loc: Shatfield, Hertfordshire
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Written by: Ry
But then (and not isolated to the pharmaceutical industry) having the first jump at something new, unique, and in demand translates to very happy shareholders.
Unfortunately, this was an anti-inflammatory, and many anti-inflammatory drugs are availble to patients, so I severely hope there was no rush.
As for a cure for the common cold, its not so easy to engineer an anti-viral which codes for over 200 strains of the common cold. And even if there was such a possibility of making such a drug, would you prefer companies to spend their resources on researching drugs for viruses which your body can fight off with in a week, or on drugs which may cure respiratory diseases, cancer and other fatal illnesses?
I'm finding this discussion extremely interesting, mainly because my degree is Pharmaceutical science, and I should hopefully be doing a placement year next year with Roche in the PDOA department which control clinical trials, and then continue my career into this field after my study.
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#713709 - 17/03/06 06:08 AM
Re: Six Men In Hospital After Drug Trial
[Re: jeff(fake)]
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had her carpal tunnel surgery already thanks v much
Registered: 27/01/05
Loc: Edinburgh
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Ry, you've made a good point about the money (not the common cold I mean, but money in general). The reason that rare illnesses are so comparatively badly researched is that even if a medicine was developed, industry would never get the money invested in 4-8 years of pre-clinical and then the clinical trials back, unless they charged 200 000 pounds per pill or something like that, and unless there's a huge charity standing behind it, universities will have trouble finding funding, too Shaolin, of course we'd help them. We give cancer treatment to smokers, liver transplants to alcoholics, get people off the mountains if they've been caught in an avalanche while going off the official tracks, try and reanimate suicide attempts and all that. Oh, and one statement I've read which makes sense, esp. compared to what I've posted on clinical trials: The one mistake that's been found by now is that they didn't start with 1 person as is the standard, but gave the substance to 6 at a time.
_________________________
"vices are like genitals - most are ugly to behold, and yet we find that our own are dear to us."
(G.W. Dahlquist)
Owner of Dragosani's left half
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#713713 - 17/03/06 06:43 AM
Re: Six Men In Hospital After Drug Trial
[Re: Asena]
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big and good and broken
Registered: 29/08/02
Loc: lunn dunn, yoo kay
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that makes lots of sense  cole. x
_________________________
"i see you at 'dis cafe.
i come to 'dis cafe quite a lot myself.
they do porridge."
- tim westwood
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#713715 - 17/03/06 06:47 AM
Re: Six Men In Hospital After Drug Trial
[Re: jeff(fake)]
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NYC
Registered: 26/08/01
Loc: NYC, NY, USA
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Written by: jeff(fake)
Written by: Patriarch917
Maybe we should add another in between stage where mothers can volunteer their unwanted fetus for medical trials.
I missed this post initially.
This is a sick joke Patriarch. To poke fun at a situation where six men may die and the emotionally sensitive topic of abortion I find unacceptable.
Amen.
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#713716 - 17/03/06 07:42 AM
Re: Six Men In Hospital After Drug Trial
[Re: UnscrupulousChavOffersFoot]
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Carpal \'Tunnel
Registered: 28/08/02
Loc: sheffield
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Written by: Birgit
It doesn't have to be a mistake... I'm not saying there was none, but a tiny minute difference in protein structure between animal and human can cause a huge difference in the response.
I wonder if some of those who advocated testing on humans in the animal testing thread have changed their mind over this? (they should, unless they advocate torture...)
Not at all, I don't see it as relevant; after all, this drug had gone through all the previous tests including computer simulations and animal testing; yet still was deadly on being given to humans.
Written by: Birgit
Oh, and one statement I've read which makes sense, esp. compared to what I've posted on clinical trials: The one mistake that's been found by now is that they didn't start with 1 person as is the standard, but gave the substance to 6 at a time.
Yes. Certainly, in the UK, though, it's fairly standard to give the drug to all the members of the group at the same time though.
Despite it being obviously better practice to give it to one first, which would in this case have saved 5 lives; because effects like this are so rare (unheard of in the UK previously I believe) there seems to be some complacency.
Hopefully the investigation will lead to a change in that policy.
I've known a lot of people who've done medical testing to make some money- I've stayed in such units twice, though one was as a standby (so no drugs) and the other was a non-drugs study (a study on long term effects of being an ex-smoker).
Co-incidently though, the day before this news broke I had been for a medical for a potential study in May.
So I did find this story to be perhaps even more disturbing than I otherwise might have.
I do appreciate that, statistically, these tests are very safe, nevertheless, I can't get out of my head that this could have been me, or any number of friends/acquaintances I've known over the years.
Lastly, I would say that the money isn't necesarily as good as it sounds- £1000 pounds for a weeks stay sounds amazing, but bear in mind that you're in 24/7, no going outside, no tea/coffee (hence guaranteed 'caffiene headaches' for those who drink regualr tea/coffee') no choice in what you're going to eat for those seven days etc.
Divide £1000 by the number of hours you're actually 'working' for, and it comes out to £5.95/hr.
Unlikely as it is, I hope they all recover, this is a horrible thing to happen to anyone and for their families as well.
_________________________
"You can't outrun Death forever.
But you can make the Bastard work for it."
--MAJOR KORGO KORGAR,
"Last of The Lancers"
AFC 32
Educate your self in the Hazards of Fire Breathing STAY SAFE!
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