159 Comments
- fyngyrz, on 10/12/2007, -20/+78Now THIS is why we should test drugs only on lawyers and politicians.
- mkjones, on 10/12/2007, -0/+32http://news.bbc.co.uk/1/hi/health/4808614.stm
^ Follow up story 'They say he needs a miracle' - inactive, on 10/12/2007, -0/+26You really shouldn't spam in your sig. It's shameless.
- KidVicious, on 10/12/2007, -3/+28Anybody else find it ironic that they were testing an anti-inflammatory drug, but the people admitted to the hosptial had "badly swollen" bodies?
- KidVicious, on 10/12/2007, -11/+35We have a reply button now.
- iliketurtles2, on 11/20/2008, -0/+23About £2k is the going rate ($3500)
My retarded flatmate is doing some drug tests over the summer holidays just so he can clear his overdraft, I printed the story and stuck it on his door - jedi55555, on 10/12/2007, -17/+38Don't even compare. Neg mode me all you want but I would rather this happen to a 1000 monkey before it happened to one human being.
- glucoseboy, on 10/12/2007, -0/+20OK, just some background. They were participating in a Phase I trial which means healthy adults, no condition, pure safety study only. At this time, the drug has had extensive testing in animals (Rats and dogs) and then an application is made to the government regulatory agency to proceed in humans (in this case, the MHRA for the UK, (FDA for US). The data is reviewed and only when the agency gives approval (which actually means does not object after 30 days) can the drug go into people.
The key thing about this story is that it is a FREAK occurrence.
Anything this toxic would never have made it into people in the first place. (one dead dog not withstanding). That's why all the authorities and companies are acting so shocked.
My guess, there was a screw up in production of this first batch of human material. Maybe there was a last-minute change in the formulation that didn't get fully tested.
Yes, when one does participate in Phase 1 trials, even though you sign off on the informed consent stating that something "bad" may happen, the general belief is that the basic characteristics of the drug are understood (roughly how toxic is it, how it is excreted, etc) One person getting severely sick or dying is always a possibility because people are so different and anyone could have some strange unknown condition. Six generally healthy people having severe adverse reaction all related to drug, now that has not occurred in recent history (past 20 years or so)
There is going to be big fallout from this incident. Huge investigation, public hearings, new laws. No question about it.
(Yes, I do work in drug development) - LoungeActx, on 10/12/2007, -3/+20they tested it on dogs first (one of which died.)
- wyattxp, on 10/12/2007, -0/+16http://www.tegenero.com/news/statement_re_tgn1412/index.php
^
Statement from the makers - dWhisper, on 10/12/2007, -1/+17Because you need a proper sample size to measure variations, along with control subjects given a placebo. They need to be in similar health and held in controlled conditions. If there was only one, there's no guarntee that accurate measures are being taken. With 4, 6, or more, you can compare results.
Sadly, here, that means that a tragedy was pushed across an entire study. - goettel, on 10/12/2007, -1/+16Here's hoping for them to recover, and wishing the family and friends all strength.
- doig007, on 10/12/2007, -0/+12As the (London) Times Law Weblog points out, you can't sign your life away. If there has been any negligence on behalf of the pharmaceutical companies, there is legal recourse.
http://timesonline.typepad.com/law_weblog/2006/03/the_drug_trial_.html - Sesse, on 10/12/2007, -1/+13Or the money you get isn't worth your life. :p
- Xanin, on 10/12/2007, -8/+20with those clinical trials you sign your life away though, so i suppose you can't complain
- Crusoe, on 10/12/2007, -0/+12http://www.tegenero.com/research__development/drug_development/index.php
More on the drug. It's a T-Cell promoter, and judging by the reactions, too good of one. I mean, the whole chemical pathway that causes T-Cell numbers to explode when you're fighting an infection also make you feel icky.
There is a rare allergic reaction that sounds somewhat like this. You know, when you're allergic to something, your immune system kicks in, and you get itchy, and if it's a skin allergy the skin gets weepy and little blisters form. Well imagine if it affected every cell in your body. People who react hyperallergically rarely survive. they even get blisters on their eyelids and eyes, and they whole body behaves like one giant rash, filling with fluid.
I'm trying to look up the name, but it is not the same as "Anaphylaxic shock". - Xanin, on 10/12/2007, -3/+14tho i agree with medical testing on animals, sometimes it wont show all the effects that it has on humans. different genes can play different roles in different organisms, despite similar sequences, due to regulatory elements, etc.
- MrBlackthorne, on 10/12/2007, -3/+13As awful as it sounds, I was just telling a coworker about this, and when he asked what the drug was supposed to treat, I started cracking up. The irony hadn't hit me until that precise moment.
- splasho, on 10/12/2007, -0/+10http://news.bbc.co.uk/1/hi/england/london/4807042.stm 'Relatives are with the patients, who suffered multiple organ failure. Two men are said to be critically ill.'
- GrinningFool, on 10/12/2007, -0/+10I though it was a cat, at least until somebody looked at it.
- sharedferret, on 10/12/2007, -0/+92,000 pounds (it's in the follow-up article).
- t35t0r, on 10/12/2007, -2/+11There are only two kinds of people that take part in clinical drugs trial tests:
1) poor blokes
2) blokes that have nothing to lose - milkfat, on 10/12/2007, -0/+9It definitely was tested on animals. From the article:
"Lawyer Ann Alexander, representing one of the critically ill men, told the BBC the companies had been asked whether any of the animals used to test the drug had died." - alphaterminus, on 10/12/2007, -0/+8For US med students, doing stuff like this is a major source of income. I have a hard time believing this made it through primate trials without causing major problems, unless the drug was contaminated or somehow measured wrong.
- prockcore, on 10/12/2007, -3/+11Side effects include nausea, vomitting, itchy rash, bloating, and failing organs. If you should come in contact with TGN1412, go to the emergency room immediately.
Do not taunt TGN1412. - zimm, on 10/12/2007, -6/+14NO!
We should test on the animal rights activists.
get use out of them somehow... - GrinningFool, on 10/12/2007, -5/+13"They have to do human testing even when there's been animal testing, which is one of the problems with animal testing."
The POINT of animal testing is to weed out the early drug failures.
Idiot. - dclowd9901, on 10/12/2007, -6/+13It makes sense. An anti-inflammatory agent is only going to work with the systems that deal with inflammation. What would be ironic is if this gave them killer erections. And that would be funny too.
- SoccerBoy, on 10/12/2007, -2/+9This is why I will never do any drug testing... my life isn't worth it.
- Lewisham, on 10/12/2007, -1/+8You are not paid in the UK for donating blood.
Sperm donation carries it's own risks, such as the eventual child tracking you down. - CosmicJustice, on 10/12/2007, -4/+10Why start with SIX humans? Why not try one first and then if he doesn't die try a second and so on?
- christuckeruf, on 10/12/2007, -0/+6They usually test the drugs on healthy people first to see the side effects.
- Web_Weasel, on 10/12/2007, -1/+7Animal testing only works when the system being targeted in the animal is similar to the same system in humans. Even then you can get iffy results. We may have one of those here.
- teamparadox, on 10/12/2007, -2/+8This reminds me of the movie Dirty Work, where they test a new fat free Brownie. Artie Lang eats like 20 of them and has no issues...Norm MacDonald eats a tiny nibble of one and he starts to see the devil, break out in nasty hives and sweat like a pig...
All joking aside I hope these people turn out ok but really...why would you want to try drugs? If your hard up for money donate some sperm and blood, at least that way this kinda crap wont happen to you. Who knows what the long term effects of some of these trial drugs could be. - dWhisper, on 10/12/2007, -0/+6I'd assume a whole ton, since this was first trial. I did a few of these in college, and made on average $1200 for a 3 weekend study. And all I was testing was Allegra in child doses (so very low risk). The higher risk, or more time intensive studies, can pay up to a few thousand dollars a day.
- Sgeo, on 10/12/2007, -1/+6"you should be banned, you ***** racist."
Not banned, just dugg down. Whatever happened to freedom of speech? - MrPhelps, on 10/12/2007, -0/+5If the person you administered the drug to dies, how do you know if it is because of the drug or the illness it was supposed to treat ? You need to test the drug on healthy people to test this.
- plumpy, on 10/12/2007, -6/+11Schrödinger had a dog, too.
- crilen007, on 10/12/2007, -16/+21I'd prefer criminals
Why kill em? Why put em in prison? Just test crap on em.
Only if they did something that was bad though, like child rape or something. - SniperX, on 10/12/2007, -0/+5Makes you somewhat re-think the $50 they offer to get you to test their stuff.
- Latentk, on 10/12/2007, -0/+5Sadly, this happens much more often then people realize. My uncle was diagnosed with a disease that will eventually kill him due to taking part in a drug test for a drug that was supposed to treat something he was currently fighting. Out of the I think 10 testers, 2 died due to side effects, with my uncle and one or two others being diagnosed with these severe diseases. Unfortunately, everyone who takes part in these tests signs a waiver removing all fault against the company testing the drugs from any liability.
- mr.hostility, on 10/12/2007, -3/+7Sell Sell Sell! Their stock line is going to look like the patients heart beats...
- cmajewski, on 10/12/2007, -1/+5No kidding, I am surprised that this doesn't happen more often....
- stead, on 10/12/2007, -0/+4Animal testing is compulsory before testing can be carried out on humans for drugs such as these. The regulations are actually very tight. This could well come down to human error.
- mmartin, on 10/12/2007, -1/+5It happens all the time, just not that bad.
- Bullsnot, on 10/12/2007, -1/+5We do, Pam Anderson is a big PETA supporter. She has been testing implants for years. :)
You wouldnt want to see poor monkeys running around with those things! - Kitsune818, on 10/12/2007, -0/+4Sometimes it makes more sense to give the drug to healthy people because an AE (adverse event) might kill the intended subject if they are already weekend by disease, etc. There are certain cases (here in the US anways) where a terminally ill patient or a patient suffering significantly from something where there is other possible course of action can be granted access to experimental treatments.
However, say you are developing a drug to increase red blood cell count (such as Procrit, I believe). You can give a small amount to a health person and see if they incur a corresponding small increase in RBC. You wouldn't want to do that to someone who is dealing with Leukemia or taking chemotherapy. - Inthraller, on 10/12/2007, -1/+5The problem with the logic of testing on small groups is that you know there is a good chance someone will die because of the drug. The drug company was probably pretty sure the drug was safe and they want to test if the drug actually works or not. Unless, of course they're completely retarded. You'd think a company would try to avoid the possible lawsuits or at least the bad press of having killed test subjects. Again, maybe I'm giving the drug company more credit than they're worth.
- Sgeo, on 10/12/2007, -0/+4If I had an otherwise terminal illness that could only be treated by the drug they're testing, I'd do it.
- HPSauce, on 10/12/2007, -0/+4I volunteered for some tests a couple of years back, when money was extremely tight (still is now though). At the time I thought nothing of it; £105, take some drugs which have already been researched thoroughly and have a check up every other day for a fortnight. Easy money.
After seeing the consequences of this one incident though, in hindsight it was a bit foolish. You're essentially risking your life in a game of chance for money; those two who took the placebos in the story must have played the luckiest game of Russian Roulette in their lifetimes.
And did anyone see the interview with the girlfriend of one of the volunteers? She was like a failed actress putting on the worst performance of her life. So many classic quotes from the interview:
"He was so good looking and hunky... to my friends, he was a stud"
"He's puffed out... like a 45 year old man with a cardiac arrest, like my father"
Topped up with a name like "Myfanwy". -
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