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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.
This sig has been temporarily disconnected or is no longer in service
It is part of federal medical research laws that prisoners cannot be used for medical testing.
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
Like this test on blood substitutes. But I guess we can wear bracelets to "opt out" of testing.
Suck a lot of terrorist cock, do you?
I luckily have a couple of extra T cells and would be willing to sell them as I could use the sick days. The bidding starts at $4,001.00 please....
This fool should be modded -5 by default.
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.
Um... yes, you can walk/stand without toes. Had a principal at one of my elementary schools who had his toes blown off by a lightning strike. Yeah, he walked funny, but he walked.
And, when I was in Korea, the bunker I worked in had a blast door malfunction. About a two-ton steel blast door dropped unexpectedly and chopped off a commander's feet... partially. Got the toes of one foot and about half of the other foot. After he recovered, he turned down the 100% disability retirement and returned to his commander's post.
Of course, whenever he went up or down stairs, a lieutenant would unobtrusively position himself on the downhill side of the stairs just in case, but the guy stayed in the Air Force and continued commanding. Big huge brass balls, he must have had.
Skivvy Niner? Email me!
HEY! Look left just ONE MORE TIME!
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.
Sean Connery, is that you?
Computers are useless. They can only give you answers.
-- Pablo Picasso
"When news of the disaster broke, TeGenero admitted liability. But it has since gone into liquidation and its insurance cover is worth only £2m, payable if court proceedings are not pursued. The company, set up for the purpose of making the drug, is not worth suing.
Modi reserves his greatest anger for Parexel, the American pharmaceutical services company. Its revenues are expected to be nearly £400m next year."
Set up a front company, close it down when something goes wrong and then regretfully say it's nothing to do with you. Class.
Oh arse
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.
I stood up and lifted my toes and I immediately fell over!
BTM
That was the turning point of my life--I went from negative zero to positive zero.
While I sympathize with the victims here... they did volunteer for this. I would be willing to wager hard money that the victims were fully briefed on the experimental nature of this drug, and went ahead anyway. If they were not, then they *would* have legal recourse.
Government's view of the economy: If it moves, tax it. If it keeps moving,regulate it. If it stops moving, subsidize it.
Shouldn't this have happened to some rabbits and mice first?
It's really scary to imagine this happening, regardless of any blanket agreement signed.
What?
...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
My mother has done several clinical trials of arthritis and related medications - we all have knees of jelly (actually, jelly would feel great compared to the grinding we all have), and she figures she can volunteer her very bad knees and hips for science in hopes that the decibel levels of the flexed knees of future generations will go down.
But you're right - the ONLY thing this kind of behavior produces is fear and tentativeness in possible subjects. Well, that and dead people. My mother would probably keep doing the studies, and I will probably do them later in life when I can afford a bit of downtime here and there. And this really is only one example in a very large list of safe(r) studies going on. But if my understanding of the medication is accurate, the "side-effects" seem to trump exactly what the drug is supposed to do, and now they're playing lawyer ball to pretend they didn't irreparably damage these volunteers.
There comes a point where humans have to be test subjects - drugs react differently in different mammals, so you can only be so sure of side-effects before you start on people. Still, this one sounds pretty ridiculous. But as long as the pharmaceutical lobby has such a grip on government, this kind of stuff will continue to happen. And eventually, you're right - it will cause people to stop volunteering for crucial roles in drug testing.
I hate to say it (because it seems off-topic and ranty), but this kind of behavior might have been avoided with some kind of real, substantive campaign finance reform. Take the politicans out of the pockets of these companies, and suddenly laws will change to reflect the needs of the voters. Just a thought.
It is pitch black. You are likely to be eaten by a grue.
$4000 may indeed be worth risking my life over if it means the well being of my family. Enjoy your upper-middle-class, 'cause the poor are less free for you.
Ignorance is bliss.
It's a lot cheaper to test drugs on poor Indians than to test them on Americans- all the more so because the Indians have a much harder time suing for negligence.
You are reading a copy of my copyrighted post.
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.
I've undergone some medical testing at a local private firm that specializes in testing the generic forms of FDA approved drugs already on the market. I went in from Thursday night till Sunday morning, two weeks in a row. I got three square meals a day, movies to watch, brought my own books to read, played some pool, and was able to rest. I came out with trackmarks on my arms and $1300 to pay for my honeymoon. No regrets. It's not that you should be scared of all medical testing, it's that you have to know what you're going in for. What I did was pretty safe and I would highly recommend it for a badly needed quick buck.
Yes, you can dance to Radiohead.
Why would anyone believe this to be true? Someone I know was born without toes. She can walk fine. In fact, she can skateboard, surf and snowboard. There is no degradation of any mobility I am aware of.
I work with various clinical trials in the UK and interest in them actually *increased* following this incident - this was because a lot of people did not realise that you could get paid for doing them.
I think the parent was a bit harsh in saying "only an ignorant would sign up for medical testing" - you should not sign up for clinical trials if you are ignorant. This compound had not previously been tested on humans, so yes there were large risks - but many trials are involving already "human tested" compounds and are merely changing the dose (such a influenza vaccine trials trying diluted doses to see if they are effective). As with everything you have to use your discretion - personally I will participate in trials only if I calculate the risk is minimal to zero, but I still will (admittedly I have the medical and scientific knowledge to make that assessment). I have recently taken part in a flu vaccine trial testing diluted doses - not for the money - but because trials like this are necessary to further our knowledge and ultimately benefit us all.
This is not a correct answer. It disrespectful for the victims of this infamy and I feel you should withdraw it! You lack perspectives if you talk like this and maintain it! Everything should not always only be down to money!
... You ain't a proper prisoner !
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?
I think this is a very poor example of the laws that you are worried about. The cheesburger bill mentioned in your article is designed so obese people can't sue McDonalds (and other fast-food industries) for making them fat. I hope that most people on /. realize that obese people are usually fat because they lack self-control, and that these people are well aware that fast food is not the healthiest of choices, nor was it advertised as such. While I have some sympathy with obese people, I don't blame McDonald's, Hostess Twinkies, or Mom's Apple pies for making them fat.
You are reading a copy of my copyrighted post.
Even though I've only seen the products that I work with used on two or three patients in the entire time that I've been here. There is a great satisfaction, and an incredible relief, when the product is first successfully used on a patient. You don't know anything about them, they don't know anything about you, but you put a bit of yourself emotionally into the product. If it causes harm, you'll feel it.
If you think education is expensive, you should try ignorance -- Derek Bok, president of Harvard
Slashdot is an anagram for Has Dolts, and I am Dolt number 468543
(doesn't come in at page 2 - not split)
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.
First of all, my condolences and utmost sympathy for the test participants for their unfortunate condition as a result of these tests.
I did RTFA but it didn't mention anything about animal testing. One other poster mentioned primate tests had been performed. Does anyone have any references for this? It would be common sense to have animal testing first, and one would expect results such as total destruction of T-cells to have been detected in animal testing.
Also, why would they select apparently healthy young individuals for the first test trials? Shouldn't they be testing on terminally ill or those already affected by auto-immune dysfunction?
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....
Hint: Look up Ayn Rand in the Wikipedia...
Aren't the PETA nutcases always going on and on how we don't need animal testing anymore?
:)
Maybe they should stump up and volunteer for these types of drug trials
Two birds with the one stone
Help! help!, the termites are eating my DRAM!!!
Stop marking dark humor as trolls! Cripes, what has become of the geek communiuty. No sense of humor, infected with conspiracy theories and extremist ideology. What happened??
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.
...here in London. Not heard any from Parexel lately but they were still advertising for a while after the TGN trial went wrong.
The TGN1412 substance they tested on monkeys was a precise fit to a
receptor on the human T-cells, but did not precisely fit the monkey
T-cells and therefore did not cause the full blown T-cell activation
when they tested it on the monkeys.
In humans however TGN1412 fits precisely into that receptor of every single
T-cell in the body regardless of what specialization which is why the
results were so dramatic even with the first (and thankfully only) dose at
a 1/500th of what the monkeys got.
Personally I think this "mistake" was on purpose but then to see that they
do that kind of research in Europe in plain view and not keep it out of
sight in the third world, now that's where it really gets creepy.
Everyone who opposes animal testing of medical products should test medical products.
Caucasian != white
Drug companies are being evil by not caring for those that have suffered serious injury or side-effects as a result of their tests. Test-subjects are stupid for having signed up in the first place, as $4000 isn't worth the possibly life-altering or life-ending side effects.
This post written under Gentoo-linux with an SCO IP license.
Different people react to things differently. Seems obvious, but you don't tend to do proper scientific studies one subject at a time.
It showed nothing of the sort. It showed that a bad outcome occured, not that a bad decision was made.
If you owed a bookie $3k, and had a few of his 'associates' had come by to remind you that your payment was due at the end of the week, and you had to compare not risking the trial, vs. making $4k, even with death as a potential outcome may be a good decision.
...
Let's take the old look at the lottery -- typically playing the lottery is a bad decision, but it can be a good decision even if the payout doesn't hit the record amounts where it exceeds (cost * risk). Now, one of your loved ones (or yourself), needed a very expensive medical treatment, or you only had 2 months to live. The success rate of the procedure was 5% and cost $150k. You have $5k in savings. and can't get a loan -- it makes perfect sense to sink everything you have in the lottery. The odds of a bad outcome (losing everything in the lottery, or still not living after the procedure) are almost assured, but the potential for gain outweighs it.
So -- when you make a decision, you have to look every possible outcome from all aspects, not just monetary, and the odds of each outcome occuring. Sometimes, you won't know exact outcomes (stock market), or the exact chance of each outcome (stock market, medical testing), and might not even know what all of the possible outcomes are (medical testing), and determine if the risk of benefits vs. the cost are acceptable to you. Bad outcomes happen. Bad decisions only occur when ignore information that is important in the decision, or you don't recognize that you don't have all of the information that is necessary to make the decision. (you can still make a good decision on incomplete information, but it's an increased risk).
Build it, and they will come^Hplain.
Well, those prisoners that have committed heinous crimes do have a large debt to society.
What better way to start to pay off that debt than to be a test subject for a drug test?
There are loads of animals that these things get tested on before the jump is made to human testing. If animals die or are poorly affected, humans should not be tested. So there should be some idea about what the drug is supposed to do, and the given results make me wonder if the regular, long process was followed..
As for saying they don't legally have to... If you sign a waiver for me that says I can help you kill yourself, I'm still up for manslaughter or murder at the end of the day, regardless of what the waiver said. Waivers that say "And if we fuck up your life, we'll reject all responsibility" is, AFAIK, just wasted paper as soon as you hit the legal system.
People give up far too many of their legal rights because they feel they've "signed them away". The law stands above contracts. Same with warranty, at least here in the Netherlands. Lots of places sell 'extended' warranty from the basic 1 year, except they don't mention that for many products the legal minimum warranty is two years, and for durable products you can expect factory-warranty for a reasonable lifespan (a fridge would be in the order of half a dozen years).
Animal testing is almost never useful in finding out what is safe for people. Even primates are still very different from people, many things that are bad for them are fine for us, or the other way around. So the way animal testing works is you test it on the animals, if they seem ok then your ass is covered when you test it on people. If it kills or injures the animals, you say its because they are too different to get useful results, and try it on people anyways. Testing things on rats and mice that make no sense at all to test on them is very popular too. Dangerous drugs that have harmful long term affects seem fine in small rodents because their lifespan is so short, they never have time to develop the symptoms. This lets the companies say "look, we tried it out on worthless disposable animals before we tried out on the wortless disposable people" when their product kills people.
Nicotine is fundamentally different from corn syrup, salt, MSG, and the like. These make food taste better but are not addictive. I don't find it disturbing that food companies make food that people want to eat, even if they do have a 'profitable science' behind how they do it.
And why shouldn't we mention "super sizing"?
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.
First of all, morality has nothing to do with it; it would have made more sense if you said "solely responsible". Nevertheless, even that is not true.
If you go to a McDonald and buy a really cheap 2"x2"x2" sandwich/burger, do you at that moment even think about how many calories it has? Would you really think that such a tiny food item have around 50% of the calories you require in a single day? Of course not! You eat it, and then you don't even feel full.
All this fast food has been engineered to appeal to your sense of taste, even though it doesn't have much nutritional value. Furthermore, as I said in the previous paragraph, after eating it you probably won't feel full, while if you eat a decent lunch you feel full afterwards (I just had a mixtue of peas & rice with a bit of chicken).
Personal responsibility is a part, but that is assuming you have been educated about proper nutrition, know the numbers, and can do the math. I really doubt that many people know much about nutrition; I don't recall McDonald clearly advertising the nutritional value of their food; and, at last, I doubt many people can do the simple arithmatic required.
Lastly, McD makes greate effort in enticing children and their parents: have you seen the latest ads where the kid is enjoying some McNuggets, while her mom is eating a salad? They are aiming to present themselves as a healthier establishment. Now let me tell you something about their salads: they suck. On TV they show you this large dish, but when you actually get that fruit salad, there is no more than a few grapes, a half of an apple, and a few walnuts -- all for no less than $4. I had it once, and I swore never again. So, basically, those "healthy foods" won't satisfy anyone, and they'll end-up getting a burger at the end.
I've mentioned children, so let me quickly elaborate on that matter: children are brainwashed by TV ads by companies trying to push their snacks/candies/cereal/junk-food. Would you also preach personal responsibility to a 4-year old? The kid will simply nag the parent, and the parent will probably end up buying it to get the kid to stop.
Advocating personal responsibility has become the prefered moral high ground some people take, and the equivalent of a scapegoat -- simply blaming someone without regard for all the other factors. This issue is in the same basket along with poverty and debt.
So, quit your preaching, get off your pedestal, and stop being a douche.
You clearly don't understand how things work here at slashdot. Nobody hear wants someone to tell them that corporations are actually made up of real people. They just want to keep shaking their fist and cursing the corporate machine.
Feel free to mod me "-1 - Angry Jerk".
Tell that to people joining the military or these mercenary outfits.
Human trials are fantastically expensive and very slow. If simulation was at all practical the pharmaceutical industry would be all over it. But people are just too complicated. An approach that documented the systems we believe are at work within the body wouldn't do the job because chemicals might change the way the systems interacted. A full cellular-level simulation would require more information about the body and more processing power than we have (and are likely to have in the next 40 years). Maybe some simulation could help decrease the number of failed tests, but we're not going to be replacing human trials any time soon.
This post written under Gentoo-linux with an SCO IP license.
Use number 3409 for rapists, child molesters and crooked politians (or is crooked politian redundant)....
Sean Connery? Don't you mean Mel Gibson?
Reminds me of those signs you see on the backs of trucks that say "Not Responsible for Objects Coming Off the Road". They are not necessarily true. They are (occasionally) liable. They just make the claim that they are not to bluff people who get their windshields banged up.
BTW, I really do hope that these poor people do get the help they need.
Weaselmancer
rediculous.
From TFA:
Indeed, although the innovative drug being tested, TGN1412, was a potent immune system stimulant that overrode the body's normal regulatory mechanisms, it was tested according to much the same standards that govern far more ordinary pharmaceuticals.
So sometimes the drug does exactly the opposite of what it's supposed to do. That's gotta sting.
I don't know who makes me more sick to my stomach, prescription drug companies or oil companies. It seems as if drug companies have looked past all practical use of medicine and have begun making up symptoms to cure. I know this to be the case when I see prescription medication for "Restless Leg Syndrome." No shit. Then a story like this comes along, from the same companies lobbying against medicinal uses of marijuana because of it's "devastating" effects. Of course, they must be reffering to the devastating effects it may have on their profits, because I don't know of anyone losing toes and fingers from sparking a j.
Similes are like metaphors
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Not trying to minimize what happened to these guys, but everyone needs to bear in mind that according to TFA this latest study was commissioned by one of the victims' lawyers:
Last week Modi received the results of Powell's medical tests, commissioned by his lawyers to establish the extent of the damage the drug has done to him. The assessment has left him in a state of shock.
Again, just another data point. I'm not saying that it isn't true in this case -- but remember that lawyers' first goal -- ALWAYS -- is to make money by successfully representing their clients. Period.
And leg amputees with artificial limbs get around how?
"It's the height of ridiculousness to say for those 9 lines you get hundreds of millions."
I found this article to be a better overview of the whole story.
I'd mod this whole article a Troll, but even with Mod points that's not allowed. Just too much of personal bias and slant in it for my personal BS meter.
"It's the height of ridiculousness to say for those 9 lines you get hundreds of millions."
The Helsinki Declaration is an international guideline governing the use of human subjects in research:
http://en.wikipedia.org/wiki/Helsinki_Declaration
Developed countries have very careful protocols in place to ensure that human subjects are treated carefully. I work in medical research, and I have filled out many proposals for human research. They will *not* begin using prisoners or other "disposable" subjects. By rules of the National Institutes of Health, medical students are not even allowed to willingly volunteer to be research subjects, for the possibility that they might be pressured by their attending physicians.
The Institutional Review Board (as we use in the States, other countries have similar safeguards) makes it an order of magnitude harder to have research approved if it involves prisoners or other "vulnerable populations", as they are called in this context. There may, however, be an increase in the price necessary to recruit volunteers.
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.
Come on, we all know what testing blood substitutes on unkowing volunteers leads to: zombification. Some kind of monsterism, at the least. Don't these people watch horror movies?
- None can love freedom heartily, but good men; the rest love not freedom, but license. -- John Milton
"[...] I predict a decline in voluntary test subjects, and a rise in the use of prisoners and other 'disposable' human subjects."
Reminds me of the Stephen King short-story "The Jaunt" where a prisoner was used to test the teleportation device.
I feel like a terrible person for this but all I can think after reading that last post is how V for Vendetta is being released on DVD tomorrow.
Remember, remember, the fifth of November...
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.
No, it is not. If it were, people wouldn't get so upset about this case. Subjects getting seriously hurt by this kind of initial safety test is quite unusual.
The reason why things went so badly wrong in this case is because (1) this is a new class of drugs for which current safety protocols don't work well, and (2) multiple people involved in the test seem to have been careless.
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.
I think there's a good chance that both companies (Parexel and TeGenero) will be found negligent in court.
Say you give the new wonder drug to one guy, and five minutes later he drops dead. Did it have anything to do with the drug? How would you know? I wouldn't want to be the next person injected with that drug.
You have to give the drug to several people at once. That susses out all the different variables that could seem like an effect of the drug. Maybe one person with heart troubles has a heart attack and dies, but no one else does. In that case, it probably was something with that particular person, and not a problem with the drug. If three people have heart attacks, however, then you there might be a problem with the drug.
In fact, to have a scientifically valid experiment, you need two groups, the experimental group and the control group. The experimental group gets the drug, and the control group a placebo. Membership of the groups must be completely randomized, and administration and receipt of the drug must be double-blind: the doctor doesn't know whether they're giving a drug or a placebo, nor does the patient know what they are getting. That way, we not only know if the drug is relatively safe, we also know if it actually *works*.
Computers are useless. They can only give you answers.
-- Pablo Picasso
At least for research funded by the United States National Institute of Health (NIH), there are very stringent requirements designed to prevent abuse of subjects. There is a short free online course describing such here.
Prisoners, for example, are given special protections precisely since they are in a disadvantageous position. I think you will agree that the policies described are very well considered.
If the T-Cells ever come back or could be supplied by transfusion wouldnt this be a perfect aids cure? No t cells means nothing to produce the virus? Or am I just being wierd and crazy...
~~ Please keep your arms, legs, and outright stupidity inside the ride at all times. Thank You ~~
...you can't walk imediately after your toes are severed ... I suspect that would hurt a bit too much to stand.
-
Don't bother troll-modding this, it's already AC & no more troll than the submitter.
Who is the submitter anyway? "A reader." Leave the editorializing for the comments, not front page submissions.
There are a few issues here:
I predict that the people who believe drugs will be tested on involuntary subjects will in the near future whip each other into a frenzy, leading them to attempt to murder people on a large scale as they gout out of control and essentially become the equivalent of deranged, aggressive animals. For this reason they should immediately be killed, alternatively removed from society so as to prevent them from doing this - I suggest starting with yourself.
Unreasonable prediction? Hey, you started it. How about we each act according to our own predictions?
Some monstrism.
It may look like I'm doing nothing, but I'm actively waiting for my problems to go away.
--Scott Adams
What editor selected this? Why on earth... what were you smoking this morning? Did your cat jump on your keyboard and accept this submission on accident?
What a load of opinionated, unsubstantiated bullshit.
A person is intelligent, people are stupid. A corporate worker is a normal human being, a corporate entity is an amoral profiteering monster.
One thing I haven't seen mentioned is the fact that Parexel is not a drug company, it is a contract research company. They did not produce the drug being tested nor were they were not the people who did the testing. Their job is to monitor what is going on whith the drug trial. Most of this information comes from the doctors and hospitals who agreed to participate in the study and are the ones that are actually giving the drugs to the test subjects.
If I can be modded down for being a troll, can I be modded up for being an orc, or a balrog?
Now the company can sell it to the military as a chemical weapon... Good times!
Umm, why does Parexel have any liability? They are a CRO, a company that helps Pharmaceuticals run clinical trials. The *sponsor* company is the responsible party. They overlooked some issues that cropped up in some of their pre-clinical trials and took the compound to the clinic. They hired Parexel to help them run a Phase I. Oh wait, I know, because Parexel has money and this fiasco has pretty much sunk the sponsor company (TeGenero).
So, why all the Parexel hate? It wasn't their compound, wasn't their trial, etc... so.. what is their liability here? Too bad this story is too old for this to get modded anywhere for people to see it.
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.
"Personally I think this 'mistake' was on purpose..."
Perhaps I'm just misunderstanding you, but are you saying that the drug companies would prefer to purposefully ruin the lives of four people, instead of trying to create a drug that works, help people, and make a lot of money?
Wow, that response was totally unexpected, and completely original.
Feel free to mod me "-1 - Angry Jerk".
This story pulls at the heart strings for sure, but it also intimates that the test itself is wrong. I don't think it's negligence THAT the beta drug hurt you; rather, it's negligence that they're not paying you for it. Someone eventually has to test a drug that may have side effects. Now if they unleashed this pill without tests... that would be negligence if the drug then hurt people.
stuff |
Say you give the new wonder drug to one guy, and five minutes later he drops dead. Did it have anything to do with the drug? How would you know? I wouldn't want to be the next person injected with that drug.
One work: autopsy
Forgive my ignorance if what i am saying is complete rubbish, but wouldn't a bone marrow transplant have a good chance of restoring the victims immune systems?
Let's skip the testing and go straight to market with experimental drugs. Or maybe we can just test on apes because apes are basically just humans with lots of hair... right?
"You had this look that of an angel, it was such a bad disguise" --Dishwalla
Did this just knock out PART of the immune system, or all of it?
If it got the whole thing the company could just hunt up compatible donors and give them bone marrow transplants - or give them cord-blood transplatns - and essentially cure them. Then they'd have a new drug that conveniently knocks out the immune system preperatory to bone marrow transplants so that radiation treatments to zap the old bone marrow is no longer needed.
If it DIDN'T get the whole thing they could still zap the bone marrow and go the normal route.
Meanwhile, either way, the victims become valuable research subjects: Pay 'em a decent wage and do the work. Good all around.
When life hands you a lemon, make lemonade.
Bantam Dominique roosters crow a four-note song. Once you've heard it as "Happy BIRTHday" you can't NOT hear it that way
While I have some sympathy with obese people
For heaven's sake, why?
They knew that if they ate too much, they would get fat.
They ate too much.
They got fat.
They could get back to normal, but they choose to go on eating too much. A fat person is an ugly sight, an eyesore. They pollute my visual environment. I don't see why anyone should have any sympathy whatsoever for them.
Then they'd have a new drug that conveniently knocks out the immune system preperatory to bone marrow transplants so that radiation treatments to zap the old bone marrow is no longer needed.
And can you IMAGINE the problems getting test subjects for such a drug WITHOUT this accident?
Bantam Dominique roosters crow a four-note song. Once you've heard it as "Happy BIRTHday" you can't NOT hear it that way
Parexel is a CRO (Clinical research organization). Parexel is hired by TeGenero Immuno Therapeutics to conduct the clinical trial for them. Parexel is not liable TeGenero Immuno Therapeutics is. Look up your own wiki. http://en.wikipedia.org/wiki/TGN1412
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.
Saw a great article on this just last week.
Secession is the right of all sentient beings.
From a lawyers perspective, if you pay them compensation outside of court, you will be sued anyways, so it makes more sense to just settle in court.
I always hear people complain about drug companies, they test all sorts of things on people not just drugs. This is bound to happen sooner or later, even if you take all necessary precautions. What're you going to do? Stop developing new drugs?
2,000 pounds is a pretty tempting offer. If they were testing something a little more common, like arthritis medicine, I think I'd take it. But if someone offered me 10,000 to test new Erectile Dysfunction medication I think I'd pass. As a matter of fact, they do pain medicine trials here at the University of Utah all the time, I did it when I was younger, they want to test paid medicine on people who are scheduled to have their wisdom teeth out. They've never had any problems.
If you read the IHT article, you will see that allowing insufficient time for serious side effects to be presented in the subjects is one of the official criticisms of the study. Giving the wonder drug to one guy and having him drop dead is exactly one of the things that they want to catch—would you prefer that they gave it to five instead and all of them dropped dead?
He's allowing others to take risks that he - and WE - all benefit from. He's just not willing to take those risks himself.
The question is whether or not the risk-takers are taking informed risks.
Is that evil? I'd say only if those that volunteer to take the risks aren't informed of the risks they're taking. And given the availability of drug testing data that any half-ass researcher can find, if the risk-takers volunteer for such tests and aren't informed, they're at least partly willfully ignorant.
without toes you cannot remain standing or walk, btw
Oh really? Better not let pirates read that.
If a murder was truley repentant they would volunteer. If they still value their life more than the possibility of helping society, they are not sorry. At that point they should be left to die.
Better yet, find a sick memeber of the victims family and test what ever drug needs to be tested, if they refuse, kill them
I believe there was a district ruling on this point years ago where they ruled that you can not sign away your fundimental constitutional rights. It was for a case dealing with employee rights.
Signing them away does show clear intent to the court; however, it does not take away their rights. Its a question wether they knew what they were getting into. Even then, you can sign something for someone to kill you but it doesn't stand because you don't have the right to death in the USA.
Aren't they supposed to test it on animals 1st?
Democracy Now! - uncensored, anti-establishment news
I'm afraid the grandparent post is the correct one. In the setting of anti-cancer therapy, most Phase I trials are carried out on patients with advanced disease and no further evidence-based treatment options.
Phase I trials are essentially "dose finding" studies. The drugs will have been tested on animals giving an indication of likely doses and toxicities in humans. Volunteers on a Phase I protocol will be exposed to serially increasing doses of a drug, until toxicity prevents the dose being escalated further (the maximum tolerated dose or MTD). After ascertaining the MTD, it becomes possible to plan a Phase II trial using the drug in a "safe" dosing band.
Phase I trials are not about identifying the side effects of a drug. They are not about finding out whether a drug works or not. They are about finding the MTD. In many cases you can get hints about toxicities and efficacy, but this information has a high probability of being misleading. Phase II and III trials address this issue.
In the setting of therapy for non-malignant disease (hypertension etc), the compounds tested in Phase I trials are expected to be relatively non-toxic. As such, they are tested in healthy volunteers for the reasons explained by the parent. Conversely, anti-cancer therapies are expected to be extremely toxic in the short, intermediate and long term. They are often associated with profound myelotoxicity and resultant sepsis, and can increase lifetime cancer risk. It is not sensible to expose healthy volunteers to these risks for the sake of a dose-finding experiment.
Testiculos habet et bene pendentes.
A lot of people have criticized the story submitter's take on the story. Now, how about some discussion on the actual story? It seems to me that what occurred was unforeseen. But that does not mean there should not be a review of what actually went wrong, what steps should be taken in the future, and if any compensation should be paid. The article claims that there quite a few irregularities in the drug test (dosing everyone together, approving the trial in 17 days, no insurance for the subjects, not responding quickly when they knew something went horribly wrong). A lot of the readers have said that people who volunteer for drug testing should be considered as "heroes". If this is so, then surely we can do better than just shrug our shoulders and expect these "fallen" to hobble through the rest of their lives. After all, when people volunteer for such tests, they expect that if something should go wrong, everything possible would be done to treat them.
Given the total disregard for human life and the vanishing probability of having to pay more than a few
thousand pounds to the survivors or rather the families for funeral arrangements and most of all the fact
that nobody will remember these people as late as this christmas... yes, I think a strong case can be
made for conducting that kind of research here...
btw I see a lot of promise here for TGN1412 as a chemical warfare agent. It is completely debilitating,
gruesomely demoralizing and leaves survivors who are in need of intensive care, the only thing left to
work out is to see whether it can be delivered say as an aerosol, how long it will stay activated
in the field and if that pans out find a process to economically synthesize larger quantities.
Call me paranoid, but that is exactly the kind of thinking of scum like that. They only care about saving
human life _IF_ there's a business case for it and there isn't always, just check out what
BAYER did when they sold off large amounts of their Koate hemophilia medication into Asia and Latin America
FULLY KNOWING that these where contaminated with AIDS while selling a safe, pasteurized and tested version
into Europe and the USA. Don't believe me. Do your own research. Just enter Koate and Aids into Google
and prepare to be apalled.
Tell you what, the next most disturbing thing about this is that three young men and the kid will be forgotten
in a few weeks from todays. I don't mean 'kid' as a put-down btw, it's just that with 21 this guy hasn't
seen shit of the world and that has me upset too.
I am a current volunteer on a study. This doesnt put me off at all.
I do however think there is a role for the trial regulator to step in force the company to provide an independently arbitrated level of support and to restrict the limitation of liability the company is allowed to apply by contract. The trial should also be insured so that the company cannot just bankrupt itself out of liability.
I am also a medical research professional, and believe if I want other people to be involved in bringing my discoveries to market I should also contribute to trials.
In my case the trial I am on was massively oversubscribed, even though the payment does not even cover expenses completely, because it is a product people want (that I am not involved in developing).
I will admit however that I am in an unusual position to be able to make informed choices as I can investigate the research and make an expert judgement on how safe I think the trial is. If I did come across a flawed trial I would not keep my opinon to myself.
We all know a few people who practice on the far fringes of health care, but in my brief observances of them, they still have the compassion left. You may hide a smile under your hand at their approaches, but sometimes they will have stumbled onto something valuble.
... builds vitamins into doggie biscuits. (Or canned meat food, but that MIGHT make you truly ill because of different fatty profiles, plus the exponentially nastier taste.) Paraphrase from the presentation. "You give your DOG more vitamins every day than your CHILD. What kind of parent are you?"
I once checked up on a startling cassette-tape presentation I came across in my bulk music purchases. The presenter said that you can ditch your $75/month supply of vitamins, and pick up a box of dog biscuits. "If you don't believe me, check the ingredients list. It's all there."
He said that this is ironically true for two reasons.
A: most people DON'T really value their pets anywhere near the level of human people, so they won't normally pay through the nose for medical treatment for Sparky. B: At the same time, the trainers want to make money off of their "High Performance" animals.
Addressing both situations, the animal industry cuts its losses and
A bulk pack of multi-vitamins from GNC is my current choice, but I tried this once. Just get a good dipping sauce.
My first Journal Entry ever, in 8 years! http://slashdot.org/journal/365947/aphelion-scifi-fantasy-horror-poetry-webzine
I live in Canada, and I volunteered for a drug test over 3 weekends that paid $1600. It had to do with arthritis. Anyhow, I was living on welfare with no money left over for food and winter clothes after paying the rent. So, uh, I kind of had to volunteer. Got through it ok, but I was really really scared doing it. I was getting dizzy, I think, because they took so many blood samples (like 20 a day)... and some of them were rude to us. They started raising their voice once when someone didn't start eating right on the second they were told to start eating (he was trying to unwrap his food), and the main guy doing the study became angry at me when I reported a side-effect. Oh well. I guess these things aren't so important. I suppose that things are much worse for people in 3rd world countries.
I heard of a parent who, when the kid starts whining for candy in the store and acting up, locates another good-behaving child. She tells the parent what she's doing and then buys the candy her kid was whining for and gives it to the other kid because they're being good.
Apparently works like a charm.
What the hell? I don't think I could go through $75 worth of vitamins in a month if my life depended on it. A bottle of 100 multi vitamins costs what, $8?
Visual IRC: Fast. Powerful. Free.
When GE Food is linked to health issues, how will the billions of people around the world sue Monsanto.
The first environmental pollution photojournalism in Minamata, Japan when a paper processing plant was dumping mecury into the water, and eveyone including babies became sick was captured by William Eugene Smith.
Photo : http://www.geocities.com/minoltaphotographyw/will
William Eugene Smith, was severely beaten by goons hired by the offending chemical company.
Who is documenting what is happining with our food sources. People certianlly need to be more aware of all the different chemicals they are exposed to on a daily bases. I am not sure if you have noticed but you are probably finding that parts of your budy are itchy.... It could be the SLS in your washing detergent.
Companies are becomming less and less liable. This has been slowly happingin over the last 100 years.
The internet is one of the few tools availible for people to look out for them selfs, and inform others. Become a memeber of the EFF and protect this important right.
Define what is "White race".
Just for your information, there are Black people that defer more from other Black groups than from some groups of White folk (when genetic material is compared).
You should be worrying about tests been done in people with a genetic make up as close to yours as possible, skin colour does not ensure this (check the skin colour of any descendts from a "mixed race" marriage. Skin is normally dark but obviously genetics will have contributions from both parents).
Many people considered White (Spaniard for example) have loads of genetic material from Black folk (Spain had Moorish people for 800 years, many of them were Black).
SO again, what do you mean with "White"?
IANAL but write like a drunk one.
US people seem ot be this weird idea that once you enter a prision all your rights are lost.
Just for your information folks citizens of the New Empire, jail prisioners have human rights that must be respected.
Respecting the rights of those people is a guarantee that your own rights will not be trampled with. Slippery slopes are a dangerous thing folks, you should stop the slip straight at the moment it starts to happen.
IANAL but write like a drunk one.
I lost my brother 12 years ago. After 3 years of painful fighting for life in Hospital he scumbed to death. He was sufferring from Aplastic Anaemia, a condition because of damaged bone marrow. He was a healthy child and once he was given a medicine for fever, not sure about authenticity of that medicine. But after that only his bone marrow was damaged. Might be my brother was victim of trial of some sort of medicine.
I'm pretty sure vitamin pills do little to nothing for your body. The only way to really get your daily intake of them is to eat the foods that contain the vitamins you need.
Do Vitamin Pills Really Work?
It's nice to heap scorn upon evil corporate entities from the comfort of your anonymous easy chair. But you should hopefully understand that the drug doesn't belong to and wasn't developed by Parexel. Parexel manages clinical trials for companies who've already invented drugs and done the labtop R&D. It is the (presumedly guilty) corporate face placed on such trials, and bears resposibility for the ethical, clinical and regulatory execution of them. Place the blame for the fate of these poor people at the feet of the company that developed the drug - not at those of the company that did everything according to well-established and strictly regulated procedure. I'm tired of the arm-chair pseudo-intellectual criticism.
Though it may not be clear enough from the earlier posts, the Indians that the testing is done on are often underinformed and have no coverage in case the drug testing goes badly (Though the Indian government is trying to pass laws to fix this). Thus, we have a case where the drug companies are exploiting people for our gain- and even though he isn't harming them himself, he is still supportive of a system in which others are exploted for his benefit. You don't have to dirty your own hands to be evil- you just have to knowingly support a dirty system.
You are reading a copy of my copyrighted post.
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