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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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  • No toes... (Score:5, Interesting)

    by RedOregon (161027) <redoregon AT satx DOT rr DOT com> on Monday July 31, 2006 @10:52AM (#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.
  • by Andrew Nagy (985144) on Monday July 31, 2006 @10:59AM (#15817696) Homepage Journal
    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.
  • 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.
  • 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).

  • 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.
  • 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 starwed (735423) on Monday July 31, 2006 @04:05PM (#15820558)

    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 actually makes any sense ^_^)


    The negligence here seems to be the way this particular trial was run by Paraxel. Who didn't, by the way, design the drug. They're a testing company, not a pharmaceutical.

  • by OldTroll (970892) on Monday July 31, 2006 @04:44PM (#15820849)
    Sigh. The problem is a failure to correctly parameterize the LD50 and LD90 of the substance. Every substance (and I do mean EVERY -- human protein, interplanetary lint or whatever else may come) has a lethal dose. It's the trials function to determine if the new drug A) works properly and B) works safely. The problem with human trials is that they aren't terminal studies. You can't have a pathologist go over each of the subjects with a fine tooth comb or do a complete histopathic workup (you can get close, but very few people want to give up heart and/or brain samples). Around here at least the trials coordinator determines the protocol to be used, which would (if this is how Paraxel runs) put the blame squarely on them (provided that the pharm company actually disclosed proper information).
  • Re:India (Score:4, Interesting)

    by LokiSteve (557281) <primate_sNO@SPAMhotmail.com> on Monday July 31, 2006 @10:03PM (#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!).
  • by TaoPhoenix (980487) <TaoPhoenix@yahoo.com> on Monday July 31, 2006 @10:35PM (#15822619) Journal
    We all know a few people who practice on the far fringes of health care, but in my brief observances of them, they still have the compassion left. You may hide a smile under your hand at their approaches, but sometimes they will have stumbled onto something valuble.

    I once checked up on a startling cassette-tape presentation I came across in my bulk music purchases. The presenter said that you can ditch your $75/month supply of vitamins, and pick up a box of dog biscuits. "If you don't believe me, check the ingredients list. It's all there."

    He said that this is ironically true for two reasons.

    A: most people DON'T really value their pets anywhere near the level of human people, so they won't normally pay through the nose for medical treatment for Sparky. B: At the same time, the trainers want to make money off of their "High Performance" animals.

    Addressing both situations, the animal industry cuts its losses and ... builds vitamins into doggie biscuits. (Or canned meat food, but that MIGHT make you truly ill because of different fatty profiles, plus the exponentially nastier taste.) Paraphrase from the presentation. "You give your DOG more vitamins every day than your CHILD. What kind of parent are you?"

    A bulk pack of multi-vitamins from GNC is my current choice, but I tried this once. Just get a good dipping sauce.

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