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Parexel Destroys Immune Systems, Not Liable
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."
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.
This sig has been temporarily disconnected or is no longer in service
It is part of federal medical research laws that prisoners cannot be used for medical testing.
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.
If you think education is expensive, you should try ignorance -- Derek Bok, president of Harvard
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.
Weaselmancer
rediculous.
Yeah, cause all test subjects are litterate and educated people who aren't starving in their regular lives.
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.
Skivvy Niner? Email me!
HEY! Look left just ONE MORE TIME!
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.
It's not my fault! It was this way when I got here.
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.
It's official. Most of you are morons.
...the cheeseburger bill that the U.S. passed a few years back. Basically the way it works is this:
1. You are worthless
2. Businesses are of incalculable value
3. Stockholders in said businesses want more and more money so the businesses can't afford to take personal responsibility for the things they do to people
4. The majority of all politicians in the United States government is unabashedly comprised of stockholders and they make the laws
5. The businesses don't want to lose money even if they are morally responsible for what they do to you so they lobby for laws that protect them and harm you
6. You are worthless
Any questions?
-"...bad old ideas look confusingly fresh when they are packaged as technology" - Jaron Lanier (Digital Maoism on Edge.o
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?
- 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.....
'This writing business. Pencils and what-not. Over-rated if you ask me. Silly stuff. Nothing in it' - Eeyore
It's a lot cheaper 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.
You are reading a copy of my copyrighted post.
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.
Because every company does what this one does, right?
Only an ignorant...what? Huh?
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.
120 characters for a sig? That's bloody useless.
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.
Yes, you can dance to Radiohead.
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.
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 hard would it have been to give the drug to one person only, and then stand back and see if anything bad happened before you give it to a second person?
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.
If you think education is expensive, you should try ignorance -- Derek Bok, president of Harvard
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.
You're evil, but at least you're honest about it. I can respect that.
You are reading a copy of my copyrighted post.
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.
You have the attitude, but lack the front-end compassion.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
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.
Information wants a fueled airplane waiting at the hangar and no one gets hurt.
This post written under Gentoo-linux with an SCO IP license.
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).
Build it, and they will come^Hplain.
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.
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 determined to be statistically effective on a group of people as similar to me as possible, just like Indians deserve to be given medicines tested on Indians.
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.
McDonalds is a global company yet it appears that the US is the only one suffering from an obesity epidemic, and you think it's McDonald's fault? Why then isn't the rest of the world suffering from obesity?
T Money
World Domination with a plastic spoon since 1984
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... Step 1, minimal animal testing. Step 2, test on humans who claim to be equal to animals. Step 3, test on other humans.
That could work!
sdb
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.
As for prisoners, talking to the doctors at the lab I was in gave me a history of why medical testing has moved from prisoners to paid labrats, paid labrats are much less likely to mess with the study protocols and screw up the results by doing things like eating things that are not on the study diet, taking drugs, working out excessively, smoking or many other things depending on the study. Drug companies got tired of getting faulty data because prisoners were violating study protocols, while paid labrats want our money so we are much more likely to behave. I know I did.
That the company is screwing over the human labrats they basically have killed is abominable, but most studies are not that risky, and as the economy gets worse and worse human testing labs will continue to have more and more people lining up for labrat jobs. I quit doing them for time reasons, I have a regular job and my own business so my free time is limited, but if I had more time I probably would still do them occasionally. I apologize for any spelling or grammar errors, I am in a hurry, may the spelling and grammar correctors take joy in my mistakes.
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.
Testiculos habet et bene pendentes.
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.
... 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?"
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
A bulk pack of multi-vitamins from GNC is my current choice, but I tried this once. Just get a good dipping sauce.
My first Journal Entry ever, in 8 years! http://slashdot.org/journal/365947/aphelion-scifi-fantasy-horror-poetry-webzine
What the hell? I don't think I could go through $75 worth of vitamins in a month if my life depended on it. A bottle of 100 multi vitamins costs what, $8?
Visual IRC: Fast. Powerful. Free.
Volunteers in Phase I studies are taking risks by enrolling, but the pharma company really screwed this one up. Lupus and cancer are the two big risks for any sort of immuno-modulatory treatment. This is why pharma companies have shied away from genetic therapies, where genes are introduced via virii--the patients tend to die from cancer. Any humanized MAb is going to have risks of autoimmune disease or cancer, but especially one targeted to a cell-surface immune receptor. Campath-1H (generic name Alemtuzumab), for example, can be used to treat MS or a certain leukemia, but can cause Graves disease (autoimmune attack on the thyroid) and depletes T-cells. Raptiva (Efalizumab), a psoriasis MAb treatment, can cause autoimmune or immune-deficiency side-effects. Parexel was lucky that all six patients didn't die of anaphalactic shock within the hour, and they definitely should have injected one patient first, to rule out catastrophic side-effects such as what occurred.
Si la vida me da palo, yo la voy a soportar Si la vida me da palo, yo la voy a espabilar