Parexel Destroys Immune Systems, Not Liable 429
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."
India (Score:5, Insightful)
Coming from someone who works in the medical... (Score:5, Insightful)
Law is subject to change... (Score:2, Insightful)
It's horrible, but (Score:5, Insightful)
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.
Decline my... (Score:4, Insightful)
Yeah, cause all test subjects are litterate and educated people who aren't starving in their regular lives.
Sensationalist Headlines Suck (Score:5, Insightful)
I know this is not a serious news site (Score:5, Insightful)
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.
Goes Hand in Hand With... (Score:2, Insightful)
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?
Victim bashing (Score:5, Insightful)
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?
animal testing.. (Score:5, Insightful)
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.....
Re:India (Score:5, Insightful)
Response to the summary... (Score:4, Insightful)
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.
Re:Coming from someone who works in the medical... (Score:2, Insightful)
As it hinted at in the summary, its much cheaper to go through litigation and the law, then to payout damages to the people whos lives have been affected. All hail the mighty corporate machine! If you get in the way, you too may lose your toes!
Re:India (Score:5, Insightful)
The drug companies don't get any bennefit from producing drugs that kill people. They don't do this on purpose.
TW
Re:Not Funny- this is actually happening (Score:5, Insightful)
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.
Re:Goes Hand in Hand With... (Score:5, Insightful)
If you have a 401k or a pension plan you are a stockholder.
4. The majority of all politicians in the United States government is unabashedly comprised of stockholders and they make the laws
Most Americans are "unabashedly" stockholders.
You are morally responsible for eating too much fast food, not the people who sold it to you. Take responsibility for your own actions. Stop being a douche.
Don't let hysteria blind you to the real mistake (Score:2, Insightful)
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?
Re:It's horrible, but (Score:4, Insightful)
Signing a contract that says,
"the company will not be held liable by the employee for blah, blah, etc..."
cannot be a defense for negligent behavior.
Contracts are about fair exchange of services, not making one party take all the risk and the other party to have none. While some contracts are not considered fair one party cannot completely assume the burden of all risks or responsibilities for both parties. Considering the violent reaction to this new drug a disclaimer saying, "we cannot be held responsible" will not hold water in court.
The shame will be that the company will not pay, for what I consider, criminial behavior.
Re:Law is subject to change... (Score:1, Insightful)
Can you say "Chemical Weapon"? (Score:5, Insightful)
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.
Evil is harming others for personal gain (Score:5, Insightful)
Re:Not Funny- this is actually happening (Score:4, Insightful)
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
Re:Whiners QWZX (Score:1, Insightful)
You'll never make it into politics (Score:5, Insightful)
Re:I know this is not a serious news site (Score:2, Insightful)
Re:It's horrible, but (Score:3, Insightful)
on the contrary, I would imagine these people knew exactly what they were doing when they went for the trials. I think "fantastically dangerous" is a little short sighted considering the volume of human trials that happen around the globe. Many of these trials are for simple drugs, or variants/redosages of existing drugs. I digress.
The main motivation for people to so clinical trials is not primarily for the betterment of medicine, it's a more selfish motive... money.
there are many people who live on, or just below the breadline that would consider such trials as a means to an end.
I even considered it myself at one point to get through university... eventually I took 3 jobs (yes, simultaneously). It was a tough decision to take, and if I fit the demographic of the clinical trial that was available to me at the time, I would have taken it. It would have easily paid for 3 semesters tuition.
don't be so quick to judge. The need to eat is a powerful motivation.
Get off your high horse and into reality (Score:1, Insightful)
Not the US! (Score:3, Insightful)
Contracting Risk (Score:3, Insightful)
Disgusting submission, even for Slashdot (Score:5, Insightful)
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.
Re:Um, most Indians are caucasian (Score:3, Insightful)
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.
Re:India (Score:2, Insightful)
Yes, the company should care for them since their drug only made things worse and to do anything else is just plain old unethical, but don't call the test subjects "morons", "suckers", "disposable" or anything else mean spirited. Have some respect for the dieing and maybe even a little gratitude that in their suffering and death they may be helping you or someone you love in the long run.
How do I know these things? I am a stage IVa cancer patient participating is a Phase I study. Hope is more powerful than fear.
Re:Goes Hand in Hand With... (Score:2, Insightful)
Re:Ronald McDonald made me do it (Score:4, Insightful)
Re:India (Score:3, Insightful)
Totally understood, but they should pay to support these test subjects. You can look at it either way.
1) Think of it as a tort. When they do hurt or kill test subjects, on purpose or not, they should make them whole again financially.
2) Think of the value added to the company. The test subjects have given their lives to provide a huge value to the company--a strong negative result is just as useful as a strong positive. (Just imagine if this drug had made it to market and resulted in a nationwide class action suit on behalf of a million people...goodbye company.) So the test subjects should be compensated in proportion to the value they provided the company.
But retarded children and low income children can! (Score:1, Insightful)
low income children can [bbc.co.uk] - in the US, at least. And not that it's not old news - 2004 for that second article and still being investigated.
Re:India (Score:2, Insightful)
But they do benefit from taking significant risks with test subjects' lives.
The drug companies should be doing as much as possible to assure the safety of the drug before the test, but not everything can be forseen. This is why we do testing in the first place.
Drug testing does have inherent risks. But people didn't get hurt by TGN1412 because of inherent risks of drug testing, they got hurt because the tests were designed and carried out irresponsibly.
Re:I know this is not a serious news site (Score:3, Insightful)
Re:Not Funny- this is actually happening (Score:1, Insightful)
Re:It's horrible, but (Score:3, Insightful)
As a 10 year medical labrat......... (Score:2, Insightful)
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.
Re:Not Funny- this is actually happening (Score:1, Insightful)
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.
Thinking without hysteria (Score:1, Insightful)
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.
Re:Goes Hand in Hand With... (Score:3, Insightful)
Counterpoint:
Which is to say, this argument you're putting forth is the one the truly wealthy use to draw our attention away from the fact that corporate misbehavior is undermining our entire society. Sure, they're destroying the environment and our health, exploiting third-world workers and wreaking havoc on their economies, putting dangerous products on the market, and so on. But they need to be able to do this to turn your $100K retirement fund into a $104K retirement fund.
The poor bear most of the costs of these behaviors, and only the truly wealthy really benefit from them. The trick here is that they want you convinced that you're in the "benefitting" camp when you're actually in the "getting screwed" camp.
If corporations adopted personal responsibility for themselves, rather than demanding it from the rest of society, we'd all be a lot better off, corporations included.
Re:Cannot use prisoners (Score:3, Insightful)
Unless, of course, that person happens to be innocent...
cancer and lupus were OBVIOUS risks (Score:3, Insightful)
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. [sciencemag.org] 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) [mult-sclerosis.org], 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) [wikipedia.org], 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.