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Parexel Destroys Immune Systems, Not Liable

Hemos posted more than 8 years ago | from the how's-that-cold-coming dept.

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."

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India (5, Insightful)

sterno (16320) | more than 8 years ago | (#15817562)

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.

Not Funny- this is actually happening (4, Informative)

paladinwannabe2 (889776) | more than 8 years ago | (#15817684)

It's a lot cheaper [wired.com] 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.

Re:Not Funny- this is actually happening (5, Insightful)

EndlessNameless (673105) | more than 8 years ago | (#15817758)

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.

Evil is harming others for personal gain (4, Insightful)

paladinwannabe2 (889776) | more than 8 years ago | (#15817828)

You're evil, but at least you're honest about it. I can respect that.

You'll never make it into politics (4, Insightful)

Opportunist (166417) | more than 8 years ago | (#15817932)

You have the attitude, but lack the front-end compassion.

Re:Not Funny- this is actually happening (3, Insightful)

Total_Wimp (564548) | more than 8 years ago | (#15817841)

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

Re:Not Funny- this is actually happening (2, Informative)

DrSkwid (118965) | more than 8 years ago | (#15818001)

Did you know ever person responds to medications differently ?

Unless you test it on your twin / clone you can never be sure, even then they will have been exposed to things you haven't and vice versa.

Um, most Indians are caucasian (1)

rpjs (126615) | more than 8 years ago | (#15818042)

Caucasian != white

Re:India (5, Insightful)

mrxak (727974) | more than 8 years ago | (#15817691)

I don't get the tone of the submission. First it seems like they're calling the company irresponsible (and it certainly sounds as if they are), but then they seem to be blaming the "test victims" for joining the study, and then they make some rather outrageous predictions. Whoever submitted this article, take a deep breath, try to calm yourself down, and understand that situations like this are rare. And drug companies aren't going to start using prisoners and whatnot for test subjects. I don't really like big pharma either, but I'm not that paranoid. You know, I bet they have a great pill for that... (kidding of course)

Re:India (5, Insightful)

Total_Wimp (564548) | more than 8 years ago | (#15817757)

I'm glad someone sensible is posting. By the way, after calming down and taking a big breath, please stop to realize that the whole purpose of drug testing is to, well, test. 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.

The drug companies don't get any bennefit from producing drugs that kill people. They don't do this on purpose.

TW

Re:India (1)

sumdumass (711423) | more than 8 years ago | (#15817975)

Yea but, at leart when using anything else that doesn't belong to you, after your done using it, you need to restore the thing to as much like the condition it came in as possible.

I guess this is the issue. It is almost like a tennent refusing to pay damages for broken windows, walls, doors, or plumbing after moving out. Especialy when thier testing a new ball bat was the direct cause of the damaGE. The drug company(ies) should have somewhat of an obligation for those testing for them. Maybe it is the system being used.

But the drug companies do have a benefit in producing drug that kill people. Actualy most of the drugs out there will kill people (even tylenol). The drugs are usualy used in doses that do not kill or with other supported drugs that will negate the deadly side effects.

Basically it says (1)

phorm (591458) | more than 8 years ago | (#15818130)

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.

Not the US! (2, Insightful)

andrewman327 (635952) | more than 8 years ago | (#15817991)

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.

Send that to israel (0, Flamebait)

YHBTAndJewsDidWtc (975687) | more than 8 years ago | (#15817564)

Jews with no toe, lol@that

Re:Send that to israel (0)

Anonymous Coward | more than 8 years ago | (#15817615)

Suck a lot of terrorist cock, do you?

Re:Send that to israel (0, Troll)

lawpoop (604919) | more than 8 years ago | (#15817635)

Sean Connery, is that you?

Who is this Clown? (0)

Anonymous Coward | more than 8 years ago | (#15817627)

This fool should be modded -5 by default.

Cannot use prisoners (4, Informative)

baywulf (214371) | more than 8 years ago | (#15817578)

It is part of federal medical research laws that prisoners cannot be used for medical testing.

Re:Cannot use prisoners (1)

baywulf (214371) | more than 8 years ago | (#15817600)

Oops didn't read the article ;-) Looks like this didn't happen in the US so I don't know what relevant laws they have protecting prisoners.

Law is subject to change... (1, Insightful)

hsoft (742011) | more than 8 years ago | (#15817604)

and to warped interpretation. PATRIOT act, guantanamo... You name it. Pharmaceutical corp really *are* evil and powerful.

Re:Law is subject to change... (1, Insightful)

Anonymous Coward | more than 8 years ago | (#15817805)

Oh please. This is fearmongering and you know it.

Fearmongering? (-1, Flamebait)

hsoft (742011) | more than 8 years ago | (#15817906)

You mean by that that I try to instill fear among US citizen for imaginary reasons? Oh please, we both know that it is the Bush Administration that is the best at this. Fox News daily "threat level" (or is it another channel? I don't watch TV.). How many time does GWB say "threat", "war", "attack", "terror[ist]" in a speech?

US citizens should genuinely be afraid of their government, walking, hand to hand (stock to stock), with pharma and military corps. As a canadian, I am. Much more than al-quaeda. Just looking at the southern minutemen makes me shiver.

Re:Cannot use prisoners (2, Funny)

Ant P. (974313) | more than 8 years ago | (#15817619)

What's the law say about biological weapons testing?

Re:Cannot use prisoners (-1, Troll)

Anonymous Coward | more than 8 years ago | (#15817624)

We don't have that kind of laws here in Latin America. We could fund a startup for medical trials for $4,000 a piece.

We have more *disposable* people than our jails can contain. Some of them to share the beds and those who are that lucky have to sleep in the garden.

We can shot both bird with the same stone.

If you're in Gitmo... (0)

Anonymous Coward | more than 8 years ago | (#15817766)

... You ain't a proper prisoner !

Re:Cannot use prisoners (1)

Opportunist (166417) | more than 8 years ago | (#15817950)

Hey, everything's voluntary, ok? Let's make a deal, you test that drug and you're out a few years early...

At least... (-1, Offtopic)

jarg0n (882275) | more than 8 years ago | (#15817593)

At least they have no detectable t-viruses...

Coming from someone who works in the medical... (4, Insightful)

Demon-Xanth (100910) | more than 8 years ago | (#15817603)

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.

Re:Coming from someone who works in the medical... (2, Insightful)

Cpoff (991199) | more than 8 years ago | (#15817694)

The problem is that just like most other large corporations, the people working on said projects really have no connection to the subjects they are working with. Sure there are the doctors and other employee's who work directly with the test subjects, but the vast majority of the company does not, and therefore despite having "feelings" cannot be bothered to give a damn about them...

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: "no connection" (3, Interesting)

Demon-Xanth (100910) | more than 8 years ago | (#15817788)

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.

They'll find some way to get guinea pigs (0)

Anonymous Coward | more than 8 years ago | (#15817606)

Like this test on blood substitutes [wired.com] . But I guess we can wear bracelets to "opt out" of testing.

Whiners QWZX (-1, Flamebait)

Anonymous Coward | more than 8 years ago | (#15817613)

You got your goddamn money, so shut the f*** up. What else do you expect? -- Ayn Rand.

Re:Whiners QWZX (1)

jml75 (923531) | more than 8 years ago | (#15817745)

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!

Re:Whiners QWZX (1, Insightful)

Anonymous Coward | more than 8 years ago | (#15817859)

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....

Re:Whiners QWZX (0)

Anonymous Coward | more than 8 years ago | (#15817921)

Hint: Look up Ayn Rand in the Wikipedia...

T cells (1, Funny)

zerocommazero (837043) | more than 8 years ago | (#15817618)

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....

MODS! (0)

Anonymous Coward | more than 8 years ago | (#15817926)

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??

It's horrible, but (5, Insightful)

Weaselmancer (533834) | more than 8 years ago | (#15817629)

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.

Re:It's horrible, but (1, Informative)

Anonymous Coward | more than 8 years ago | (#15817735)

I don't agree.

When you sign up for testing, you mentally prepare yourself for some side effects. Oh I might be sick for a few days, whatever, at least I'm getting paid.

These people were promised that there would be NO serious side effects.

From TFA:
Parexel, the American firm that administered the tests, told them there would be no serious side effects.


Going from that to their immune system turning on yourself/shutting down... well then...

I didn't know chopping years off your life/severly hampering what little you have left isn't considered a serious side effect.

Re:It's horrible, but (2)

MoneyT (548795) | more than 8 years ago | (#15817787)

Having worked with the public on numerous occasions and knowing about teir selective memory (and knowing how anal retentive lawers are) I would guess that the actual statement from Parexel was "There should be no serious side effects" to say otherwise is outright lying as the purpose of the TEST is to see what's going to happen. Promises to the contrary were probably not made, but people seem to not understand the english language these days. 6-8 weeks does not mean call us up in 6 weeks demanding to know where your stuff is.

Re:It's horrible, but (1)

mrdaveb (239909) | more than 8 years ago | (#15817737)

I wouldn't say that clinical trials are fantastically dangerous. In fact I would say they are fantastically important.

I don't know how many thousands of these types of tests have been conducted in the UK over the decades, but this is the only one I've ever heard of that has gone spectacularly wrong. Just the fact that this was front page news should tell you this is unusual. Researchers don't just synthesise some random chemical then find someone to jab it into... at the very least there are lab mice involved...

Re:It's horrible, but (0, Troll)

Red Flayer (890720) | more than 8 years ago | (#15817779)

Bah. It's Darwinism. Stupid enough to take the risk, stupid enough to get out of the gene pool. That company has done the human race a favor.

/saracasm.

I'm sure the reason why they're not isn't greed so much as a fear of litigation.
I think it's also to limit future liability... what happens if their next Stage 2 or Stage 3 research injures a bunch more people? We're talking several millions in medical expenses for each patient in this case. Setting a precedent like that is Bad News for big pharma and their stockholders.

Re:It's horrible, but (3, Insightful)

Herkum01 (592704) | more than 8 years ago | (#15817801)

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:It's horrible, but (3, Insightful)

gigne (990887) | more than 8 years ago | (#15817953)

"What part of "testing" didn't the subjects understand before they volunteered?"


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.

Re:It's horrible, but (1)

ikandi (699246) | more than 8 years ago | (#15818128)

This comment is overrated as the poster has failed to address his own question, and thus makes a ludicrously inappropriate suggestion that the guinea pigs were properly informed of the risks. They were not. In fact they were specifically told there would be no danger at all to their long term health, a false proposition for any physician to make and especially in the case of a novel drug that produced anomalies in animal testing. I suggest you consult the copious heavyweight UK media coverage for the chain of ethical and clinical failures. The immediate aftermath will be an eye-opener for anyone who thinks unease with Big Pharma is some kind of luddite plot.

Decline my... (3, Insightful)

pVoid (607584) | more than 8 years ago | (#15817630)

I predict a decline in voluntary test subjects, and a rise in the use of prisoners and other "disposable" human subjects

Yeah, cause all test subjects are litterate and educated people who aren't starving in their regular lives.

Re:Decline my... (4, Funny)

Red Flayer (890720) | more than 8 years ago | (#15817729)

Yeah, cause all test subjects are litterate and educated people
I'm not sure why, but I think I just voided the warranty on my irony drive train -- my irony-ometer is redlining.

Re:Decline my... (0)

Anonymous Coward | more than 8 years ago | (#15817815)

If you're calling someone illiterate because they wrote "cause" instead of "because", you might as well return that little irony-drive train device of yours to Walmart for a refund.

No toes... (5, Interesting)

RedOregon (161027) | more than 8 years ago | (#15817632)

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.

Re:No toes... (1)

Hektor_Troy (262592) | more than 8 years ago | (#15817954)

Big huge brass balls, he must have had.
Well .. maybe he just had a live-in mother-in-law?

Sensationalist Headlines Suck (4, Insightful)

Gnascher (645346) | more than 8 years ago | (#15817634)

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.

Makes me shake my head in despair... (0)

tomknight (190939) | more than 8 years ago | (#15817636)

You have to assume they knew this was possible:

"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.

Re:Makes me shake my head in despair... (1)

tomknight (190939) | more than 8 years ago | (#15817667)

May I retract some of that. No, Parexel did not set TeGenero up as a front company, they "merely" administered the tests. Apologies.

Please mod my parent post into obscurity, then this one! Tom.

Re:Makes me shake my head in despair... (0)

Anonymous Coward | more than 8 years ago | (#15817893)

Parexel may not have been the puppetmaster, but a company with no other drugs, no other funds, and only 2M in insurance most certainly sounds like a front for something.

I know this is not a serious news site (5, Insightful)

Tim C (15259) | more than 8 years ago | (#15817639)

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.

Re:I know this is not a serious news site (2, Insightful)

Crussy (954015) | more than 8 years ago | (#15817949)

I agree 100%. Don't we have editors here that screen submissions? We have seen some poorly made summaries before and even ones with false information, but this brings it over the top. It is terrible that this happened to the victims, but flaming everyone from the company right on down to other testees is in plain bad taste.

Wow, poster is right! (0, Offtopic)

Billy the Mountain (225541) | more than 8 years ago | (#15817645)

I stood up and lifted my toes and I immediately fell over!

BTM

Hmm... (1)

sarlos (903082) | more than 8 years ago | (#15817646)

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.

Re:Hmm... (1)

Opportunist (166417) | more than 8 years ago | (#15818026)

"This drug might cause ($medical_phrase_in_latin) or ($more_latin_words) in people with allergies to ($some_more_inspellable_words) or with people in their family suffering from ($medical_term)."

Now imagine this going on for about a letter sized page and take 2 things into account: First, who wants to look like an idiot who doesn't know the first thing, and second, you need those 3k bucks for your mortgage and if you ask too much, the line with other poor folks who would sign this thing without asking is long.

Animals Don't Wear Underpants (1)

TheRequiem13 (978749) | more than 8 years ago | (#15817649)

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.

Re:Animals Don't Wear Underpants (1)

bcat24 (914105) | more than 8 years ago | (#15817725)

According to Wikipedia [wikipedia.org] (yeah, I know, not the best source), they *did* do animal testing without finding any problems.

Re:Animals Don't Wear Underpants (0)

Anonymous Coward | more than 8 years ago | (#15817920)

According to Wikipedia (yeah, I know, not the best source), they *did* do animal testing without finding any problems.


Also according to Wikipedia, third parties [wikipedia.org] expressed an opinion that forseeing such a reaction may not have been "rocket science" for scientists in the know.

Re:Animals Don't Wear Underpants (5, Informative)

LurkerXXX (667952) | more than 8 years ago | (#15817852)

The drug was tested in mice. And in primates.

Drugs often have different effects in humans than in test animals. There are a number of disease we can sucessfully treat in lab rats that we can't in humans because the biology is different. Sucessful tests in animal studies is merely an inidcator that a drug may work in humans, it's no guarantee. Likewise, some drug that may work well in treating a human disease may never make it to clinical trials, because the animals it was tested on had a bad reaction to it due to their different biology.

The big screwup in this trial was giving it to a number of patients, for the first time, only minutes apart. This is NEVER supposed to be done with a new drug. (There are clinical trials going on one floor above me right now. Everyone in the place shudders when they heard these idiots did that). You always test which you think is a very small dose (like these poeple did, thinking it was 500x less than what they thought would be a safe dose from the animal models), then you wait for a few days to make sure there are no major reactions to it. Injecting numerous people within minutes is crazy. If they'd merely wated an hour before trying to inject the 2nd person, they would have stopped, and there would only be one person with a toasted immune system right now.

There will always be occasional bad results in drug trials. This one was greatly exacerbated by the incompetence of those performing it.

Goes Hand in Hand With... (2, Insightful)

eno2001 (527078) | more than 8 years ago | (#15817651)

...the cheeseburger bill [bbc.co.uk] 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?

Re:Goes Hand in Hand With... (5, Insightful)

pianoman113 (204449) | more than 8 years ago | (#15817775)

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

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.

Ronald McDonald made me do it (1)

paladinwannabe2 (889776) | more than 8 years ago | (#15817778)

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.

Re:Ronald McDonald made me do it (1)

eno2001 (527078) | more than 8 years ago | (#15817890)

You are unaware of the whole picture. The fact is that most of the food industry uses ingredients in their food that are known to increase appetite. Corn syrup, high levels of salt, MSG, etc... They do this because it makes people want to buy and eat more and more of their food. There is a whole science behind this because it's very profitable. With the passage of that bill, people cannot sue companies who intentionally produced food to increase consumption, not to mention "super sizing". Can you imagine if the cigarette industry got a bill passed that said they couldn't be held accountable for people being addicted to the nicotine additive? Same thing.

Re:Ronald McDonald made me do it (1)

snarlydwarf (532865) | more than 8 years ago | (#15817989)

No, it's not the same thing.

Corn syrup, fat and salt are not addictive.

They make processed food the way they do because a) sugar and fat taste good and b) sugar and fat are cheaper than actual spices and flavoring.

It has more to do with "value meal" (how can we make cheap cheeseburgers for a buck and still have people think they're edible?) than some sort of "get them addicted to cheeseburgers, they will come in for a fix every day, and then we can make a fortune on the coke and fries!"

Re:Ronald McDonald made me do it (1)

eno2001 (527078) | more than 8 years ago | (#15818046)

Think what you want. The levels of obesity here in the U.S. indicate that something has changed and it is something that has little to do with will power or self control.

Re:Ronald McDonald made me do it (1)

GooberToo (74388) | more than 8 years ago | (#15818063)

Actually...much of the food researched used by fast food companies are performed for exactly the same reasons. For example, the cheese used on McD's produces the same results drug users get...for a very short time. The end result, while not addictive, results in the direct association between feeling good and eating their food. Thusly, it becomes an emotional crutch, much like an addiction.

So yes, you can compare the actions of fast food companies with the likes of tobacco companies. To the same degree? No.

Re:Goes Hand in Hand With... (2, Informative)

djaj (704060) | more than 8 years ago | (#15817892)

Say what you want about US politics, but I haven't found a shred of evidence that the US has turned this bill into law. Your link only says that it passed through the House. I haven't found anything that says that the Senate approved it anywhere. Most likely, they didn't even take it up.

That said, there are far more consumer-hostile business-friendly laws in the US than this proposed one. The part of the recent Medicare law that prevents the US government from negotiating drug prices with the pharmaceutical companies springs to mind.

Victim bashing (5, Insightful)

springbox (853816) | more than 8 years ago | (#15817655)

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.

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?

Re:Victim bashing (0)

Anonymous Coward | more than 8 years ago | (#15817996)

51, you ignorant fool!!

animal testing.. (4, Insightful)

rilister (316428) | more than 8 years ago | (#15817665)

- 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.....

Re:animal testing.. (1)

pianoman113 (204449) | more than 8 years ago | (#15817826)

A plethora of studies on DDT have shown that it is harmful to neither humans nor animals. The evidence presented to the head of the EPA was ignored when the DDT ban was signed.

DDT could have saved millions of lives and could save millions more, yet environmental activists armed with emotion and propaganda forbit it.

Re:animal testing.. (1)

guruevi (827432) | more than 8 years ago | (#15817881)

Computer simulations on some very expensive hardware. Sure it would cost more for them to develop such software but I think it's possible as long as you have enough resources and computer power. We are geeks after all, we come up with these idea's. But isn't that what Folding@Home and other related scientific projects are trying to do? Simulate some cells folding stuff. If you put all medical models so far in a database and put some time, power and money in it, then it is possible.

I also think it is possible to create a thinking machine like that. We are but the sum of our own thoughts and decisions and they are not more complicated than yes or no with a small probability calculator. Do I go to work: yes (75% keep job, 25% less free time) or no (25% keep job, 75% less free time). Put that in a gigantic database and fire some things on it and what it doesn't know, it learns (that's what we do ever since we are born) by looking at the results and evaluating whether it was more efficient or not.

IANAD (Doctor) but I guess cells and stuff are not that complicated, we evolved out of a single cell organism and some energy a few thousands of years ago or were we designed intelligently after all? We are intelligent enough (single cell organism) to create machines (energy) that can do this, right... or should we leave it to a deity after all? (This is not a flame, just how I would motivate scientists)

Re:animal testing.. (1)

Karma Farmer (595141) | more than 8 years ago | (#15817885)

i believe there's some evidence that TeGenero overlooked/minimised some adverse reactions in primate subjects

What do you mean "you believe there's some evidence?" Either evidence exists, or evidence does not exist. Put up or shut up.

Re:animal testing.. (1)

Sancho (17056) | more than 8 years ago | (#15817938)

Some of the problems alleged by the Wiki are that the drug trials were improperly administered and that the differences in humans and primates may not have been taken into account. These are both issues which could have been prevented.

Similarly, they allegedly gave the doses approximately 2 minutes apart, and the first negative symptoms were displayed shortly after the last patient was injected. With 8 people in the test, that's 16 minutes. If they'd stuck to the implied 2 hour delay, they would have been able to abort the test long before a second human being was injected.

Lastly, the issue is compensation. With everything that went wrong, the companies in question have an obligation to provide care for these people. Unfortunately, by the time it's all sorted out in the legal system, it may be too late to give them anything resembling a life (if they are even alive at the end of it).

But what allows this to happen? (1)

eck011219 (851729) | more than 8 years ago | (#15817668)

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.

Re:But what allows this to happen? (1)

eck011219 (851729) | more than 8 years ago | (#15817929)

Okay, I read the main article but didn't read the India Times one - now I know that the lobby has nothing directly to do with this stuff. Sorry for the uneducated post.

The Price of Informed Consent (0)

Anonymous Coward | more than 8 years ago | (#15817681)

$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.

Re:The Price of Informed Consent (1)

vivian (156520) | more than 8 years ago | (#15818002)

Yeah, we should do all our testing on animals only. Lots and lots of animals.
Oh wait. Wasn't there a vocal group here not so long ago decrying animal testing?

So how many hours of CPU time do you devote to protein folding and simulation? How much would be needed to be able to simulate these drugs and all their complex interactions with the human body and with each other?

There is no simple solution for drug testing that will please everybody.
We can't test everything on animals because it's cruel and also not a complete model for humans. We can't test everything on people because the early stages (way before this leve of trials) would often kill them. We don't have enough CPU power if we combined every computer on the planet to simulate a single drug in a human fully, so we have to use the best combination. Simulate what we can, then move to animal trials then finally to human trials when it looks safe enough.

  At the very least though, we should expect that those that volunteer for drug tests are at least looked after properly when there are effects that will affect them permanently, like maiming, crippling of their immune systems or organs, or death.

If these guys just suffered temporary pain you could say "well they got $4000 so fairs fair" but they are suffering a lot more than that, and deserve a lot more compensation than $4000.

After all, we need people like these guys that will put their skins literally on the line to help develop tomorrow's cures and treatments. I personally am not prepared to volunteer for this stuff. I think it's a bit harsh to those that did volunteer to call them moronic or stupid just because they went into an experiment they were told would have minimal side effects.

Response to the summary... (3, Insightful)

PFI_Optix (936301) | more than 8 years ago | (#15817693)

"But it seems Parexel, despite having the moral responsibilty for the outcome of its incompetence


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.

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.


Because every company does what this one does, right?

In other words, only an ignorant would sign up for medical testing.


Only an ignorant...what? Huh?

I predict a decline in voluntary test subjects, and a rise in the use of prisoners and other "disposable" human subjects.


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:Response to the summary... (0)

Anonymous Coward | more than 8 years ago | (#15817887)

In other words, only an ignorant would sign up for medical testing.

Only an ignorant...what? Huh?


Obviously, you were making fun of the poster; nevertheless, you could've wrote what word he should've used: ignoramus.

Not all Medical Testing is this dangerous (2, Interesting)

Andrew Nagy (985144) | more than 8 years ago | (#15817696)

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.

You can too walk and stand without toes (3, Informative)

Maury Markowitz (452832) | more than 8 years ago | (#15817718)

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.

Clinical trials (5, Informative)

Daevid (992299) | more than 8 years ago | (#15817739)

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.

Don't let hysteria blind you to the real mistake (2, Insightful)

mgh02114 (655185) | more than 8 years ago | (#15817777)

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?

Ads - Trying to tell me something? (1)

vtechpilot (468543) | more than 8 years ago | (#15817803)

The add that was served up with this article; and I don't even need the money.

Paid Medical Research
Get Paid to Participate in Medical Research and Mystery Shopping
www.______.com
Medical Research Trials
Search & apply to medical research trials (paid & patient) listed here
www.______.co.uk
BioPharm Insight(TM)
Drug Pipeline, Trials, Deals, Sales Companies and Project Managers
www.______.com

Can you say "Chemical Weapon"? (4, Insightful)

wisebabo (638845) | more than 8 years ago | (#15817821)

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.

Editorials on the front page? (1)

MacBoy (30701) | more than 8 years ago | (#15817836)

I can't remeber ever seeing such obviously editorial content posted on the /. front page:
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.
Submission laced with such strong opinion should not be posted, IMHO. That type of espression of opinion is better left to this forum, not the front page. The front page should link to external articles (even if they too are editorials), not be an outlet for contributors to express their opinions before the readers even have a change to read the articles for themselves. Am I wrong?

due dilligence before human tests (1)

Dr_Art (937436) | more than 8 years ago | (#15817850)

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?

PETA (0, Flamebait)

IckySplat (218140) | more than 8 years ago | (#15817923)

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 :)

Get off your high horse and into reality (2, Insightful)

IceCreamGuy (904648) | more than 8 years ago | (#15817967)

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.

Still plenty of ads for drug trials on the radio (1)

rpjs (126615) | more than 8 years ago | (#15818019)

...here in London. Not heard any from Parexel lately but they were still advertising for a while after the TGN trial went wrong.

Monkey T-Cells vs. Human T-Cells: slightly differ (1)

gd23ka (324741) | more than 8 years ago | (#15818021)

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.

Human Testers (0)

Anonymous Coward | more than 8 years ago | (#15818033)

Everyone who opposes animal testing of medical products should test medical products.
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