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Parexel Destroys Immune Systems, Not Liable 429

Posted by Hemos from the how's-that-cold-coming dept.
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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Parexel Destroys Immune Systems, Not Liable More

Parexel Destroys Immune Systems, Not Liable

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  • India (Score:5, Insightful)

    by sterno ( 16320 ) on Monday July 31, 2006 @11:43AM (#15817562) Homepage
    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 (Score:5, Informative)

      by paladinwannabe2 ( 889776 ) on Monday July 31, 2006 @11:58AM (#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 (Score:5, Insightful)

        by EndlessNameless ( 673105 ) on Monday July 31, 2006 @12:07PM (#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.

      • Re:Not Funny- this is actually happening (Score:4, Insightful)

        by Total_Wimp ( 564548 ) on Monday July 31, 2006 @12:17PM (#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
        • 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.
        • Caucasian != white
          • Ok. I looked it up in Wikipedia. You're right. Except for the part that it's not very relevant to medicine. Native Indians have a different disease profile than whites. Diseases affect them differently and at different rates. Drugs are unlikely to have the exact same effects.

            A guy in a post above pointed out that each person reacts differently than others to the same drug. He's right. But groups of people statistically react the same. If i'm going to be taking medicine, I'd prefer to know it was det

      • Re:Not Funny- this is actually happening (Score:4, Funny)

        by snowgirl ( 978879 ) on Monday July 31, 2006 @03:41PM (#15819780) Journal
        First they were outsourcing our IT jobs, now they're outsourcing our test subject jobs? When will it end?

        *promptly picks up her ticket to hell on her way off the stage*

    • Re:India (Score:5, Insightful)

      by mrxak ( 727974 ) on Monday July 31, 2006 @11:59AM (#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 (Score:5, Insightful)

        by Total_Wimp ( 564548 ) on Monday July 31, 2006 @12:07PM (#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
        • 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 syste

          • Re:India (Score:5, Interesting)

            by mrxak ( 727974 ) on Monday July 31, 2006 @12:56PM (#15818176)
            And this is where my dislike for big pharma comes into play.

            Where is the profit? To understand any business, you have to recognize the source of profit. For drug companies, the profit is in treatments, not cures, not vaccines. So most of the research money goes into treatments for things that will produce a heavy profit, and keeps you on their treatments. What's the point in producing a $50 one-time shot that will fix your ills if they can instead get you on a $200-a-month pill regimen that comes with some side effects that you'll want to take another set of pills for? A strategy like this, combined with thousands of ads telling you to ask your doctor about who knows what, combined with essentially bribing doctors to prescribe their pill for every little thing, and you have yourself a lot of profit. Even if you have somebody working on a cure for AIDS or cancer in these companies, they're not as well funded as somebody working on the newest E.D. pill or or the latest made-up condition.

            I know people who have worked in non-profit medical research, the kind of people who want an actual cure for things, but they just can't compete with the budgets of companies practically printing their own money. Public grants and donations just can't produce the kind of miracle drugs that we desperately need.

            • Re:India (Score:4, Interesting)

              by LokiSteve ( 557281 ) <primate_s&hotmail,com> on Monday July 31, 2006 @11:03PM (#15822509)
              combined with essentially bribing doctors to prescribe their pill for every little thing

              Check out No Free Lunch(http://www.nofreelunch.org/aboutus.htm [nofreelunch.org]). They are a group of doctors that all promise not to talk to drug reps and instead get their information by reading medical publications and research papers (Imagine that!).

        • Re:India (Score:3, Insightful)

          by snowwrestler ( 896305 )
          The drug companies don't get any bennefit from producing drugs that kill people. They don't do this on purpose.

          Totally understood, but they should pay to support these test subjects. You can look at it either way.

          1) Think of it as a tort. When they do hurt or kill test subjects, on purpose or not, they should make them whole again financially.

          2) Think of the value added to the company. The test subjects have given their lives to provide a huge value to the company--a strong negative result is just as useful
      • 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! (Score:3, Insightful)

      by andrewman327 ( 635952 )
      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.

  • Cannot use prisoners (Score:5, Informative)

    by baywulf ( 214371 ) on Monday July 31, 2006 @11:45AM (#15817578)
    It is part of federal medical research laws that prisoners cannot be used for medical testing.

  • Coming from someone who works in the medical... (Score:5, Insightful)

    by Demon-Xanth ( 100910 ) on Monday July 31, 2006 @11:48AM (#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.
    • 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 wh

      • Re: "no connection" (Score:4, Interesting)

        by Demon-Xanth ( 100910 ) on Monday July 31, 2006 @12:11PM (#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.
        • 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.

  • It's horrible, but (Score:5, Insightful)

    by Weaselmancer ( 533834 ) on Monday July 31, 2006 @11:52AM (#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.

    • 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 involv

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

        I'd actually say they're both.

        Personally, I'd liken being a drug tester to being an astronaut. A lot of benefit, a lot of risk. And the risks are pretty up front for both occupations.

    • Re:It's horrible, but (Score:4, Insightful)

      by Herkum01 ( 592704 ) on Monday July 31, 2006 @12:12PM (#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.

      • Contracting Risk (Score:3, Insightful)

        by cbr2702 ( 750255 )
        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.
        Risk taking can be a service. We can have a contract to exchange your money for my risk taking in order to further some purpose.

      • 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. [typepad.com] 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.

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

      by gigne ( 990887 )

      "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

    • 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 t
      • 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..

        You should wonder. What with various "animal rights" organizations that imply (if not state outright) that animals are equal to humans, animal testing is being reduced.

        Hmm, here's an idea... St
    • Yeah. I mean, while I participate in drug studies myself, via BioKinetics [bkcaus.com], I always read the study notes carefully before signing up. I've already decided I'm never going to be involved in testing any drug that's completely new. Alternate formulations of drugs that are already known to be safe is one thing--and those tests really aren't even the same kind of testing as the ones the article is about; they're to see how the drug disappears from the bloodstream over time, as they already know what it does--but
    • I don't see why a company shouldn't be held liable for the damage its tests causes to volunteers, I don't care if it was previously untested in humans or not. The corporation should have a good idea of the risks through prior modeling and tests, and taking responsibility for their own test subjects is the acceptable thing to do. I don't see paying as an admission of guilt, unless they knowingly tested a dangerous substance. Mistakes sometimes do happen, and tests and modeling don't show all the flaws.
    • [sarcasm] How compassionate. [/sarcasm] Disregarding the possiblity that some of those volunteers were in great need of that money, but just did it for a 60 inch plasma, perhaps you should consider that at no point did they sign up to die. They didn't sign up to something they were told was "fantastically dangereous". They signed up to a test that they were assured the company had taken the necessary steps to assure its safety. You might think bungie jumping is crazy. That doesn't mean that if someone dies

  • Decline my... (Score:4, Insightful)

    by pVoid ( 607584 ) on Monday July 31, 2006 @11:52AM (#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.

  • No toes... (Score:5, Interesting)

    by RedOregon ( 161027 ) <{moc.rr.xtas} {ta} {nogeroder}> on Monday July 31, 2006 @11:52AM (#15817632) Homepage Journal
    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.

  • Sensationalist Headlines Suck (Score:5, Insightful)

    by Gnascher ( 645346 ) on Monday July 31, 2006 @11:53AM (#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.

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

    by Tim C ( 15259 ) on Monday July 31, 2006 @11:53AM (#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.
  • 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.
    • "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 lo
      • So... wait... they knowingly sign up for an experimental drug test... The fact that they may not be able to understand the liability release form throwing up another red flag... the very fact that a libaility release form was needed in the first place throwing up yet another... but they still sign up for it. They made the conscious choice to participate. No one twisted their arm or hooked electrodes up to their nipples... They did this of their own free will.

        It may be the 'right thing to do' for
        • Well, what alternative is there? Oh, right, they could've sold their kidneys.

          Again, for the record, the average "test specimen" is not living in Beverly Hills and wearing Gucci Shoes. We're talking about people who need money. Direly. More often than not, their choices are limited (provided they want to stay on this side of the law).
          • That still does not absolve them of the personal responsibility for participating in an experimental drug test. At least they are getting compensated for it, and the vast majority of these tests do not have such dire consequences. I do not understand this predeliction to blame the corporation for what an individual voluntarily does...
  • ...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

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

      by pianoman113 ( 204449 ) on Monday July 31, 2006 @12:09PM (#15817775) Homepage
      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.

      • If you have a 401k or a pension plan you are a stockholder.

        Counterpoint:

        While much has been made in recent years about growing stock ownership across the entire population, the top one percent of stock owners in the United States still hold almost half of all stocks, while the bottom 80 percent own just 4.1 percent. Almost two-thirds of all households have stock holdings worth 5,000 dollars or less.[src [commondreams.org]]

        Which is to say, this argument you're putting forth is the one the truly wealthy use to draw our attent

    • 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 McD
      • 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 imag
        • 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!"
          • 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.
          • 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?
        • Okay... so basically they are adding sugar and salt to make their food tastier. And they are using science to do this! Wow. Those evil, evil people. You know, I should sue my mom- she adds corn syrup and salt to her food too!
          Seriously, people should take responsibility for their own actions instead of trying to blame other people. In this drug case, the drug company should take responsibility and help these people out. These people were trying to help them test their products, and the drug company

        • 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. ... 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?

          Nicotine is fundamentally different from corn syrup, salt, MSG, and the like. These make food taste better but are not addi

    • 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 pharmaceutica

  • Victim bashing (Score:5, Insightful)

    by springbox ( 853816 ) on Monday July 31, 2006 @11:54AM (#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?

  • animal testing.. (Score:5, Insightful)

    by rilister ( 316428 ) on Monday July 31, 2006 @11:56AM (#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.....
    • Comment removed based on user account deletion
      • 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). Ma

      • Re:animal testing.. (Score:3, Informative)

        by ponos ( 122721 )

        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...

        IAAD and I can tell you that the proper analogy to a living cell is a soup of molecules, reacting in numerous unpredictable ways. Let's put this in perspective: (a) protein folding has been proven to be (t

    • 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.
    • 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 bee

  • Response to the summary... (Score:4, Insightful)

    by PFI_Optix ( 936301 ) on Monday July 31, 2006 @11:59AM (#15817693) Journal
    "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.
  • 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

  • You can too walk and stand without toes (Score:4, Informative)

    by Maury Markowitz ( 452832 ) on Monday July 31, 2006 @12:02PM (#15817718) Homepage
    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 (Score:5, Informative)

    by Daevid ( 992299 ) on Monday July 31, 2006 @12:04PM (#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.
  • 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 ha
  • 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"? (Score:5, Insightful)

    by wisebabo ( 638845 ) on Monday July 31, 2006 @12:15PM (#15817821) Journal
    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.
  • 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

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

  • Lessons in decision making: (Score:4, Interesting)

    by oneiros27 ( 46144 ) on Monday July 31, 2006 @12:56PM (#15818172) Homepage
    The lessons are that $4000 is not worth risking your life over

    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).

  • Disgusting submission, even for Slashdot (Score:5, Insightful)

    by John Nowak ( 872479 ) on Monday July 31, 2006 @01:09PM (#15818281)
    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.

  • Ouch (Score:2)

    by robson ( 60067 )
    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.

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