Stories
Slash Boxes
Comments

News for nerds, stuff that matters

Slashdot Log In

Log In

Create Account  |  Retrieve Password

Parexel Destroys Immune Systems, Not Liable

Posted by Hemos on Mon Jul 31, 2006 10:41 AM
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."
+ -
story
This discussion has been archived. No new comments can be posted.
The Fine Print: The following comments are owned by whoever posted them. We are not responsible for them in any way.
 Full
 Abbreviated
 Hidden
More
Loading... please wait.
  • India (Score:5, Insightful)

    by sterno (16320) on Monday July 31 2006, @10:43AM (#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.
    • by paladinwannabe2 (889776) on Monday July 31 2006, @10:58AM (#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.
      • by EndlessNameless (673105) on Monday July 31 2006, @11:07AM (#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.
      • by Total_Wimp (564548) on Monday July 31 2006, @11:17AM (#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.
          • 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
      • 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, @10:59AM (#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, @11:07AM (#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
        • 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
          • Re:India (Score:5, Interesting)

            by mrxak (727974) on Monday July 31 2006, @11:56AM (#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.
    • 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.
      • Re:India (Score:3, Informative)

        this was an experimental drug for the treatment of leukemia in Phase I testing. They don't just pull people off the streets for that. Phase I cancer drugs are tested on terminal, or near terminal patients who WILL die from their disease.

        How do I know these things? I am a stage IVa cancer patient participating is a Phase I study. Hope is more powerful than fear.

        Uh, no. Phase I testing is when drugs are tested on 100% healthy subjects for the sole purpose of determining what side-effects and health problems a
  • Cannot use prisoners (Score:5, Informative)

    by baywulf (214371) on Monday July 31 2006, @10:45AM (#15817578)
    It is part of federal medical research laws that prisoners cannot be used for medical testing.
  • by Demon-Xanth (100910) on Monday July 31 2006, @10:48AM (#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.
      • Re: "no connection" (Score:4, Interesting)

        by Demon-Xanth (100910) on Monday July 31 2006, @11:11AM (#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.
      • This is kind of a silly attitude. The very fact that a human test is necessary indicates the possibility, however slighty, that a dangerous response is possible. From what I can tell from reading online, there was plenty of animal testing done, including exposing other primates to the substance, but it responded uniquely to human biology. (One possibility, apparantly, is that because the production of the drug involved human proteins, the safe dosage was much lower in humans. I have no idea if that actu

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

    by Weaselmancer (533834) on Monday July 31 2006, @10:52AM (#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.

    • by Herkum01 (592704) on Monday July 31 2006, @11:12AM (#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.

      • 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.
    • "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

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

    by pVoid (607584) on Monday July 31 2006, @10:52AM (#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)

    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.
  • by Gnascher (645346) on Monday July 31 2006, @10:53AM (#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.
  • by Tim C (15259) on Monday July 31 2006, @10:53AM (#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.
  • Victim bashing (Score:5, Insightful)

    by springbox (853816) on Monday July 31 2006, @10:54AM (#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, @10:56AM (#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.....
      • 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

  • by PFI_Optix (936301) on Monday July 31 2006, @10:59AM (#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.
  • by Maury Markowitz (452832) on Monday July 31 2006, @11:02AM (#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, @11:04AM (#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.
  • by wisebabo (638845) on Monday July 31 2006, @11:15AM (#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.
  • by oneiros27 (46144) on Monday July 31 2006, @11:56AM (#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).

  • by John Nowak (872479) on Monday July 31 2006, @12:09PM (#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.
    • by pianoman113 (204449) on Monday July 31 2006, @11:09AM (#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

    • by LurkerXXX (667952) on Monday July 31 2006, @11:19AM (#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.
      • by tpjunkie (911544) on Monday July 31 2006, @12:21PM (#15818381) Journal
        If this drug was in fact tested on mice at one point during its development, it is outrageously irresponsible that a few thousand dollars were not spent to procure knockout mice containing human immune systems, which have been around for two years now. Sure they're quite expensive, I believe around a grand or so a piece, but seeing as they contain entirely human immune systems (and thus T-cells) a trial with these mice might have saved quite a bit of human suffering.
        • by LurkerXXX (667952) on Monday July 31 2006, @12:54PM (#15818711)
          Are you talking about SCID mice? I'd argue that those are very very far from 'normal' human immune systems, and might not have yielded much better safety data than the mice they used. It would be another nice model to test in, but it's still going to have a very different respnse to many agents than a fully human system/body.