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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

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  • 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.
  • 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.
  • 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.
  • by Anonymous Coward on Monday July 31, 2006 @12:03PM (#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.
  • 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.
  • by LurkerXXX (667952) on Monday July 31, 2006 @12:19PM (#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 djaj (704060) on Monday July 31, 2006 @12:23PM (#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.

  • by DrSkwid (118965) on Monday July 31, 2006 @12:37PM (#15818001) Homepage Journal
    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.
  • by LurkerXXX (667952) on Monday July 31, 2006 @01:54PM (#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.
  • Re:India (Score:3, Informative)

    by NMerriam (15122) <NMerriam@artboy.org> on Monday July 31, 2006 @03:09PM (#15819479) Homepage
    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 drug can cause. You can't use sick people to test for side-effects, because then you don't have any idea what is caused by their disease and what is caused by the drug.

    The most cursory glance at a Google search on clinical trials will verify what i've said here. (heck: Wikipedia clinical trials [wikipedia.org])

    I've been a participant in many Phase I drug trials and this story is pretty scary but also a great example of how the ignorance of volunteers can be taken advantage of -- I always researched the drugs before joining a trial, and flat-out refused to do anything that was a cancer/leukemia treatment. Indeed, American testing labs generally limit healthy volunteers to only testing a single cancer treatment EVER in their lifetime because they are one of the few kinds of treatments that can cause real damage in the few short weeks of a trial.

    Unfortunately, I've met several people who would go to different labs and lie, because the payments can be fantastic -- $15,000+ for a few weeks in a facility testing a cancer drug. That's pretty tempting to a financially stable person, nearly irresistable to someone with no education or professional qualifications. Fortunately there are few enough labs that do such studies that it would be tough to do more than a handful without going to foreign labs (indeed London is a popular destination -- I confess I expected their liability standards to be similar to ours, now I'm glad I never went).
  • Re:animal testing.. (Score:3, Informative)

    by ponos (122721) on Monday July 31, 2006 @05:55PM (#15820936)
    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 (theoretically) NP complete for a single protein, (b) a cell contains N (where N can be VERY large) molecules that may interact, and obviously (c) you need to test N*(N-1)/2 protein interactions in order to get a complete view of the system. Also, note that many scientists (including Penrose) seriously think that some cellular processes are sensitive at a quantum mechanical level (don't ask details, I am not a physicist).

    Complicated enough?

    Now take into account that cells rarely act alone and will influence or be influenced by nearby cells or hormones or drugs or million other things. Even if you know what an individual cell will do, it's really hard to predict how a tissue or an organ or an organism will eventually react.

    The bottom line is that this is fantastically complicated. Nevertheless, predictive computational models can be very useful by screening for obvious failures and dangers. Even if a mega computer manages to improve the drug testing process by 1% (which is a load of money) that will probably easily offset its price. Don't expect it to get 100% computerized anytime soon.

    P.

  • by mcphail (859743) on Monday July 31, 2006 @07:47PM (#15821591)
    I'm afraid the grandparent post is the correct one. In the setting of anti-cancer therapy, most Phase I trials are carried out on patients with advanced disease and no further evidence-based treatment options.

    Phase I trials are essentially "dose finding" studies. The drugs will have been tested on animals giving an indication of likely doses and toxicities in humans. Volunteers on a Phase I protocol will be exposed to serially increasing doses of a drug, until toxicity prevents the dose being escalated further (the maximum tolerated dose or MTD). After ascertaining the MTD, it becomes possible to plan a Phase II trial using the drug in a "safe" dosing band.

    Phase I trials are not about identifying the side effects of a drug. They are not about finding out whether a drug works or not. They are about finding the MTD. In many cases you can get hints about toxicities and efficacy, but this information has a high probability of being misleading. Phase II and III trials address this issue.

    In the setting of therapy for non-malignant disease (hypertension etc), the compounds tested in Phase I trials are expected to be relatively non-toxic. As such, they are tested in healthy volunteers for the reasons explained by the parent. Conversely, anti-cancer therapies are expected to be extremely toxic in the short, intermediate and long term. They are often associated with profound myelotoxicity and resultant sepsis, and can increase lifetime cancer risk. It is not sensible to expose healthy volunteers to these risks for the sake of a dose-finding experiment.

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