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Parexel Destroys Immune Systems, Not Liable
A reader writes: "The four TGN1412 test victims learned recently that they have no detectable t-cells, which makes it "likely" (read certain) they will suffer from numerous diseases and truncated lifespans. It has been determined that Parexel was negligent in its aftercare of the victims. The victims have already suffered severe injuries such as gangrene requiring the amputation of all toes and three fingers (without toes you cannot remain standing or walk, btw) and endured unimaginable agony. But it seems Parexel, despite having the moral responsibility for the outcome of its incompetence and the financial ability to pay proper restitution (estimated yearly revenue of $750 million) is ignoring the victims and using the legal system to avoid liability. The lessons are that $4000 is not worth risking your life over, that that is what you are doing if you are foolish enough to volunteer for medical testing whatever promises you receive not withstanding, and that if you are so foolish you will be left to die by the company responsible without legal recourse should things go wrong. In other words, only an ignorant would sign up for medical testing. I predict a decline in voluntary test subjects, and a rise in the use of prisoners and other 'disposable' human subjects."
Actually a lot of drug testing is happening in India these days. Lots of capable doctors there and lots of people they consider disposable. Good times.
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I work at a company in the medical field, and we have to go through various tests and the like to make sure things are safe. But I consider the shirking of responsibility on that company as "Seriously Fucked Up". They should step upto the plate and do everything that they are capable of. If I were one of the people working on that project, I can't describe the feeling I would have knowing that happened.
If you think education is expensive, you should try ignorance -- Derek Bok, president of Harvard
and to warped interpretation. PATRIOT act, guantanamo... You name it. Pharmaceutical corp really *are* evil and powerful.
perception is reality
What part of "testing" didn't the subjects understand before they volunteered?
I'm not trying to troll, honest. But injecting something brand new into your body before anyone knows exactly what it does is fantastically dangerous. That's probably why you have to sign the waver that's longer than your arm, I'd imagine.
Still, IMHO the company should help these poor people out even though they don't legally have to. I'm sure the reason why they're not isn't greed so much as a fear of litigation. If they pay them any money, that looks like an admission of guilt.
Whole situation with liability and lawsuits in this country these days pretty much sucks. It hurts more people than it helps.
Weaselmancer
rediculous.
Yeah, cause all test subjects are litterate and educated people who aren't starving in their regular lives.
Ok ... I didn't RTFA, so I'm not going to comment on that.
First, let me state that it sucks to become a "medical victim" no matter how you got there. By my rant below, I don't want to take away from anything they're going through.
But, I'm going to take exception to the submitter's parenthetical comment "(without toes you cannot remain standing or walk, btw)", and call utter shenanigans.
1. I know someone who lost half a foot in a m'cycle accident. He walks without a perceptible limp, and can run too ... but looks a little funny running, and can stand very well on his half-foot, while holding the other (good) foot in the air. He is not an athlete, or posessiong of any special abilities ... just an "average joe" who had a bad accident.
2. Stiltwalkers don't have toes at the bottom of thier stilts. They walk and stand fine.
3. People with prothetic legs don't have toes. They stand pretty good too. Some of them even run phenominally well with those snazzy running legs. No toes there.
So ... yes, it REALLY SUCKS what these people are suffering due to medical incompetence, but you don't need to add your own un-informed flavor to the headline.
3.
It's not my fault! It was this way when I got here.
But could we tone down the flamebait in the submissions a notch?
People volunteer for medical testing all the time. Most of the time, nothing (serious) goes wrong. Yes, this time, something fucked up big time; a regrettable tragedy, and certainly cause to examine the rules and regulations surrounding testing on humans. But the reason it was such big news is that it's such a rare occurence. If it happened all the time, it wouldn't have been headline news.
I refuse to believe that this was the best submission on the subject. The submittor is entitled to his opinions, of course, but the place for those opinions is down here with the rest of us, not on the front page.
Still, got to keep those ad impressions coming somehow, I guess.
It's official. Most of you are morons.
...the cheeseburger bill that the U.S. passed a few years back. Basically the way it works is this:
1. You are worthless
2. Businesses are of incalculable value
3. Stockholders in said businesses want more and more money so the businesses can't afford to take personal responsibility for the things they do to people
4. The majority of all politicians in the United States government is unabashedly comprised of stockholders and they make the laws
5. The businesses don't want to lose money even if they are morally responsible for what they do to you so they lobby for laws that protect them and harm you
6. You are worthless
Any questions?
-"...bad old ideas look confusingly fresh when they are packaged as technology" - Jaron Lanier (Digital Maoism on Edge.o
This was obviously something the submitter put in, and it's pretty disgusting that it would make the front page. If this were a comment I have a feeling it would have been modded down to oblivion. How many times is it necessary to call these people ignornat and foolish?
- i believe there's some evidence that TeGenero overlooked/minimised some adverse reactions in primate subjects: if so, they should be hung out to dry by every court in the US and Europe.
Meanwhile - this is exactly how drugs get developed *all the time*. You can't pick and choose. If you saw some of the benefits that drugs in this class are have for (literally) millions and millions of people around the world, perhaps you might say it's worth it. Potential treatments for cancer, alzheimer's disease, the list is endless.
After all, these people are volunteers - we couldn't possibly develop new drugs without someone stepping forward to try them. Compare this count (four people, seriously injured) to, say famous cases where too little testing was done: DDT, thalidomide spring to mind.
Before you wail on 'evil drug' companies treating people as 'disposable', give me one half sensible alternative to regulated drug trials.....
'This writing business. Pencils and what-not. Over-rated if you ask me. Silly stuff. Nothing in it' - Eeyore
It would be incompetence if they had released the drug to market, or at least attempted to. The whole point of clinical testing is to look for problems like this that couldn't be predicted, and did not turn up in animal testing.
Because every company does what this one does, right?
Only an ignorant...what? Huh?
Prisoners can't be used, and I'd say a subject that can be bought for $4,000 is disposable enough for a pharmaceutical. Unless you're saying that they are evil enough to abduct indigents for testing. Of course, the duress of being kidnapped would impact test results making any studies virtually useless, and couldn't very well be used with the FDA.
I predict "a reader" needs to tighten his TFH.
120 characters for a sig? That's bloody useless.
As long as it means I get effective drugs without risking my neck as a test subject, it is in my own best interest to pursue this method of testing.
And, no, this post is not a troll. Deem me "cold-hearted" if you will, but I am most serious in admitting my joy that others will be exposed to the danger while I am able to reap the benefits.
---
According to the latest ruleset, this post should be modded as Vorpal Flamebait +5.
Testing is necessary, there is no way around that. Someone, somehow, somewhere, is going to be the first human to be injected with any new drug. If you are morally opposed to human testing of new drugs, then you need to refuse to take any medication even invented. (The same is true for animal testing, by the way)
The mistake made here was clear: do NOT inject a new drug into several people AT THE SAME TIME. In the interest of saving time and money, they gave the drug to several people at once. How hard would it have been to give the drug to one person only, and then stand back and see if anything bad happened before you give it to a second person?
Wow something that blows away all T-cells in your body for good leaving the victims alive but consuming huge amounts of health care just to stay remain alive.
I didn't RTFA but if this is something that can be put into drinking water, we're all in trouble. I hope I don't get super negative Karma for posting this.
You're evil, but at least you're honest about it. I can respect that.
You are reading a copy of my copyrighted post.
Did you all know that women respond differently to many medications that men? Did you know that black people respond differently than white people? I'm a white guy. I sure hope they continue to do plenty of testing on white guy's in the future. I'd hate to die because my medicine doesn't work as well on caucasions as it does the people of Indian.
In an ideal world, people would have drugs tested on all racial and gender type roughly equally, or at least according to the relative percentage of the population (which, of course, means Indian people perhaps should get more testing). This is rarely the case. Remember, when you test your drugs on people who are "expendable" you're really only hurting yourself in the long run unless you're just as expendable as they are.
(note: prisoners are alson not representitive of the general population. Do you want your antidepresents tested exlusively on criminals who have a much higher incidence of mental health problems and illegal drug use than the population as a whole? That would be rather silly, I think)
TW
Shooting from the hip? When some information is so wrong, it makes the rest suspicious. There are a lot of people who function fine without toes, walk, jog, etc and it is not generally noticable to an observer. Many mountain climbers, I personally have known a couple, have lost their toes due to frostbite. Still climb mountains and do everything else that I do, only better....
You have the attitude, but lack the front-end compassion.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
It's pretty obvious that you're the one who's "ignorant." Drugs are what raises the carrying capacity of the human race. Take a damn environmental science course and your teacher will draw it out for you - rise in technology/medicine = greater max human population. These things happen. It's terrrible. If you made a post to that effect we would have all agreed and moved on. But when you call people who go in for medical testing "ignorant" and flame the entire pharmacutical community you're just being a dick who doesn't know what they're talking about. I think "Brave" or "selfless" might be closer to an appropriate adjective for these people. These are the same people who allow you to live your life without worry of dying every time you catch a cold, so stop being a jerk and make a real post.
Americans reading this story and thread need to remember that the laws are different in different countries. Because something happens in London does not always mean that it would fly in the States.
Information wants a fueled airplane waiting at the hangar and no one gets hurt.
This post written under Gentoo-linux with an SCO IP license.
This submission is absolutely disgusting. There is no reason to insult the victims of such a terrible tragedy. Furthermore, the people that take part in these things generally do so because they are in desperate need of money. To call them ignorant and say people who do such things deserve what they get is perhaps itself the most ignorant thing I've seen on Slashdot (and no, I'm not new here). Not only are these people just doing what they need to do to provide for their families, but they're also allowing all us of to live better lives through what they're doing.
This is such ignorant, offensive crap, that I'd support banning the submitter from the site. There is no place here for such rampant stupidity, insensitivity, and complete lack of basic reasoning skills. Furthermore, Hemos needs to be kicked in the balls for permitting such a thing. If such nonsense was posted as a comment here, that would be terrible enough, but that this is being put forth as if it were fact (or anything other than delusional ranting for that matter) is insane and beyond irresponsible.
Ok. I looked it up in Wikipedia. You're right. Except for the part that it's not very relevant to medicine. Native Indians have a different disease profile than whites. Diseases affect them differently and at different rates. Drugs are unlikely to have the exact same effects.
A guy in a post above pointed out that each person reacts differently than others to the same drug. He's right. But groups of people statistically react the same. If i'm going to be taking medicine, I'd prefer to know it was determined to be statistically effective on a group of people as similar to me as possible, just like Indians deserve to be given medicines tested on Indians.
McDonalds is a global company yet it appears that the US is the only one suffering from an obesity epidemic, and you think it's McDonald's fault? Why then isn't the rest of the world suffering from obesity?
T Money
World Domination with a plastic spoon since 1984
But retarded children and
low income children can - in the US, at least. And not that it's not old news - 2004 for that second article and still being investigated.
It is the fact that the parent's point of view is widespread that makes me want to not procreate.
As for prisoners, talking to the doctors at the lab I was in gave me a history of why medical testing has moved from prisoners to paid labrats, paid labrats are much less likely to mess with the study protocols and screw up the results by doing things like eating things that are not on the study diet, taking drugs, working out excessively, smoking or many other things depending on the study. Drug companies got tired of getting faulty data because prisoners were violating study protocols, while paid labrats want our money so we are much more likely to behave. I know I did.
That the company is screwing over the human labrats they basically have killed is abominable, but most studies are not that risky, and as the economy gets worse and worse human testing labs will continue to have more and more people lining up for labrat jobs. I quit doing them for time reasons, I have a regular job and my own business so my free time is limited, but if I had more time I probably would still do them occasionally. I apologize for any spelling or grammar errors, I am in a hurry, may the spelling and grammar correctors take joy in my mistakes.
How about if you're dying of a disease, and you can't get access to a promising clinical trial because you're not in India?
How about the fact that the trust factor goes away if these trials aren't carried out as carefully as possible (which doesn't seem to be important in your point of view).
I assume you'd want intelligent, involved people involved in these tests, who can speak up for all of their experience, rather than people who'd be afraid to speak up about symptoms because they don't want to get cut off.
Actually, you're "only an ignorant" if you get as hysterical as in the above quote. Some experiments are quite safe, some less so. That's why we need to evaluate the risk before participating--read the consent form carefully and do a bit in independent thinking and investigation.
When I used medical experiments as an additional source of income, I looked for high pain/low risk ones. They paid well and, because the drugs being tested were well-known, involved no real risk. One I participated in confirmed the old folk wisdom that alcohol (in my case a liter of tonic water laced with vodka) really does dull our sense of pain and doesn't just leave us too befuddled to notice. Another helped to confirm that a drug long used in surgery because it has fewer side-effects than morphine should also work well with cancer patients. In the latter case, I was well paid for doing good.
So, don't write off medical experiments, just look carefully before you leap. And pay particular attention to the clauses about how complications will be handled. If they don't make the proper legal promises there, then it makes sense not to sign up.
--Mike Perry, Editor: Eugenics and Other Evils by G. K. Chesterton.
"Actually, I wouldn't mind it if the person is on death row with appeals exhausted. The person on death row killed one (or more!) people to get there.... save a lot of other lives."
Unless, of course, that person happens to be innocent...
Volunteers in Phase I studies are taking risks by enrolling, but the pharma company really screwed this one up. Lupus and cancer are the two big risks for any sort of immuno-modulatory treatment. This is why pharma companies have shied away from genetic therapies, where genes are introduced via virii--the patients tend to die from cancer. Any humanized MAb is going to have risks of autoimmune disease or cancer, but especially one targeted to a cell-surface immune receptor. Campath-1H (generic name Alemtuzumab), for example, can be used to treat MS or a certain leukemia, but can cause Graves disease (autoimmune attack on the thyroid) and depletes T-cells. Raptiva (Efalizumab), a psoriasis MAb treatment, can cause autoimmune or immune-deficiency side-effects. Parexel was lucky that all six patients didn't die of anaphalactic shock within the hour, and they definitely should have injected one patient first, to rule out catastrophic side-effects such as what occurred.
Si la vida me da palo, yo la voy a soportar Si la vida me da palo, yo la voy a espabilar