User Panel
Posted: 3/16/2006 12:06:32 AM EDT
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They have to test the drugs on someone. They knew the risks and took the money. It does go bad sometimes. Thats why its called experimentation and clinical trials.
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Sounds bad, but I wouldn't count on your source for reliable news. Can you find anything about this from other sources ?
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More,
www.timesonline.co.uk/article/0,,2-2088290,00.html They tested this stuff on animals and they died?! And they STILL used it on people?!!!!! |
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Unbeliveable... |
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Same result, different head and those guys would call Bill Gates poor. |
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It's a cover for Willy Wonka's three course meal chewing gum experiments. They are turning into blueberries..
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yeah, monkeys were put on this earth for a reason |
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Yup, they were put here to evolve into people dumb enough to go to drug-trials and take shit with no idea what it's going to do to them. |
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Link to highly reputable news source………
www.telegraph.co.uk/news/main.jhtml?xml=/news/2006/03/16/udrug.xml&sSheet=/portal/2006/03/16/ixportaltop.html I'm on a clinical trial at the moment with my Arthritis treatment, been on others before… ANdy |
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Good source, no doubt...one of the test subject's Girlfriends. From the Sun Article (quote from the Drug Company Rep):
I'm witholding any kind of comment on what went wrong until I can see some unbiased reporting. How many/what kind of animals was the drug tested on? If some died, what was the ratio? What did they die of? What kind of regulations does the British Pharmaceutical Industry fall under? Are they as restrictive as the FDA testing requirements? |
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I feel sorry for those guys. Must be a really horrible feeling knowing your head is starting to pop
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Drug trial ignored guideline on safety
The Times March 16, 2006 Drug trial ignored guideline on safety By Nigel Hawkes, Health Editor DRUG trials that left six healthy volunteers fighting for their lives did not conform to best medical practice, The Times has been told. Senior doctors expressed concern that all six were given the same dose of the experimental drug TGN1412 at the same time. According to the standard medical text, trials of this sort should avoid giving all the doses simultaneously. The Textbook of Pharmaceutical Medicine specifically gives warning that such practices can be “very difficult to manage” and “put subjects at unnecessary risk”. Last night the Medical and Healthcare Products Regulatory Agency was urgently investigating what went wrong in the the trials, as families kept up a vigil at the patients bedsides. It is trying to determine whether it was a fault in production, contamination or more likely an intrinsic problem with the drug itself. “They haven’t got a cure,” said Myfanwy Marshall, whose boyfriend fell ill 90 minutes after taking the drug. “This is a drug they have never tested on humans before so they don’t know what they are dealing with. It’s completely messed up their vital organs.” There was confusion last night about whether the drug had been tested successfully on animals before the tests on human volunteers. “They [the drugs company] said there was an oversensitivity in monkeys,” Ms Marshall said. She went on to say that in the tests a “dog and some animals had died . . . so they reduced the amount to humans”. Thomas Hanke, chief scientific officer of TeGenero, last night refused at a press conference to say whether animals had died during earlier tests. “There has been no issue on the safety of the drug on animals. This is not relevant,” he said. He said the drug had been tested on mammals but not dogs or rats. He said that the company had apologised to relatives of the six ill volunteers. “We are devastated at these shocking developments which we were not anticipating. The investigation must proceed as quickly as possible (into) the testing of a new medicine which showed no signs of any safety problems in previous testing.” Lawyers have been instructed on behalf of at least one of the victims. All six remained in care at Northwick Park Hospital, northwest London. Two were said to be in critical condition and the other four were serious, but showing signs of improvement. Relatives met doctors and staff from the two companies involved — the German biotech company, TeGenero, and Parexel, the contract company that was conducting the trial. The trial protocol had been agreed with the MHPRA and was carried out “according to strict ethical and regulatory requirements”, according to Parexel. The MHPRA yesterday refused to give precise details, citing commercial confidentiality, and questions to Parexel went unanswered. But TeGenero confirmed that all six volunteers had been given scaled doses of the drug according to their body weight. The tragedy, experts said, should result in a review into the way future trial are carried out. Professor Sheila Bird, from the Medical Research Council’s Biostatistics Unit at Cambridge, said: “It is very unusual to have a tragedy in one volunteer in a trial like this, far less to have all six involved. ” That could have been avoided, she said, if at the start only one of the volunteers had been given the drug. All were healthy young men who had volunteered for the first human trials of a new arthritus drug, developed in Germany. Professor Bird, citing the recommendations made in The Textbook of Pharmaceutical Medicine, a standard work on the subject. suggested that the trial would have been better to test two or three volunteers on day one, before other volunteers were given their dose. However, Chris Springall of Covance Clinical Research, a company based in Yorkshire that carries out drug trials, said that the practice by which the whole group was given a dose at the same time was normal in the industry. But it was not considered risky because side-effects were so extremely rare. “I've been in this business 20 years and I've never known anything of this nature before,” he said. http://www.timesonline.co.uk/article/0,,2-2088290,00.html |
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IMO, not the most sensitive thing to say. |
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Im not a sensitive PC guy. Sorry to piss in your Wheaties, but the truth is: it does suck to be them. |
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Fair enough. I certainly don't envy the position they're in, I think the situation sucks and I hope the doctors are able to save their lives. |
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it sucks, and if there was negligence then I hope the company gets screwed, however the people knew the risks!
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From the articles, these were youngish guys who were testing an arthritis medication. If they were young *and* had arthritis, odds are it was one of the severe childhood-onset types. I know someone who had one a few years ago, and she expected to be dead before she was forty. She was around 25 and had undergone multiple joint replacements. The pain she endured on a daily basis would make you wet your pants, cry, and pass out. When you are seriously ill and existing treatments don't do anything for you, testing something new might be your only hope for some relief. That isn't "dumb", that's just desperation. ETA: read another article on it, and it said the guys were HEALTHY. WTF??? Ok, I take my comment about "desperation" back. I guess I'll wait to find out what really happened. . . . |
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This is why we have the FDA in the US. Trials cannot proceed in such a haphazard fashion here. Europe is our test bed.....
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Yeah, the FDA. They've saved thousands of lives -- at the cost of millions of lives. AIDS medications in particular. Hey, those guys are dead meat. There was no point in delaying medications for years over safety considerations for people who were going to be dead in a couple of years if they didn't get something to suppress the course of the disease. But noooooOOOOOoooooooOOOooooooOOoooooo, the FDA had to drag out approvals forever just to be "sure" that the side effects wouldn't kill them. Same goes for some cancer medications; I had a coworker who was about to die, then suddenly a manufacturer got a miracle cure for his rare cancer approved. If the FDA had delayed it another two months, he probably would have been dead already. |
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+1 |
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It was my understanding that experimental drugs were tested in clinical trials on people who have the disease that the drug is designed to treat. At a certain point, if existing medications aren't helping you, it must feel like you have nothing to lose. You'd have to understand the risk going into it that the drugs could either improve your condition, have no effect, or make it worse. Very sad though if this is because proper protocol wasn't practiced.
Horrible. |
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......wanted trial cash to take his mum on hol.....
Those Brtish - I just love the way they talk!!!!! |
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I've read the article, I think victims were fine physically when they went into the trials. I remember in the USofA, there was a drug test at a midwest university where a healthy test subject unexpectely died in drug test, the US FDA came down on them like a ton of bricks.
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Heard some info about this yesterday. It is a phase one trial which is generally a risk assessment trial and they use healthy people that volunteer and get paid. For this trial they got 3500.00 which for a trial is very high, according to the report I heard. Typically in a phase one a single subject will get the medicine if anything goes wrong they stop or go one from there and then they tell the second person what happened to the first and so on down the line. The phase one is just looking for bad things to happen. In the later phases they do all of the placebo stuff and add several users etc. In this one they had eight people with two of them being placebo. So all six got messed up. Also in general they keep the money low so that they don't get people that will keep coming in for trials as a job.
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Okay, I wasn't sure how that worked.
Sounds pretty risky to me. There's got to be easier ways to make money. (I'm currently looking into the possibility of getting into a trial for the melanoma vaccine, but I believe that it's well into phase III, it's been going for years.) |
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Be realistic, the FDA did not cause any of these people to contract AIDS or cancer. They are responsible for the safe research, testing and implementation of palliative medications and biological implants. Without the FDA would be a total medical/legal fiasco in regards to the pharmaceutical and biotech industry. No one would dare bring anything to market. Even when testing is done appropriately, devastating judgements still come against companies like DOW and MERCK for the "atrocities" of silicone breast implants and Vioxx. They are the sole reason there are not more class action lawsuits over ever single adverse reaction. |
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It sure sounds fishy that it passed animal tests and yet within minutes of injection the human patienets were in agony. There is definitely much more to this story.
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Yeah, and I don't think the human head can increase 3x in size without something busting open in an immediately lethal way.... Sabotage by PETA? |
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Seriously! As I read the articles, the thought most on my mind was "Damn! Now i just GOTTA see THAT shit!" |
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If the FDA approves a drug that KILLS people, then the shit will realy hit the fan. There will be lawsuites from hell and heads will roll at FDA. What about those who arn't going to die in 6 months and take this wounder drug and die? |
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As odd as it may sound, the FDA would be in a world of legal hurt if they rushed approval for drugs because "victims would die anyways." Cancer victims can certainly sue over botched treatments even if their prognosis doesn't entail their living to see the restitution.
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Highly unusual, but not fishy at all. Animal tests do not always correlate to human use, that is why human testing is essential. Thalidomide is a prime example, animal testing did not show the potential for phocomelia birth defects. Baytril is another example - it is used in veterenary applications but not humans (causes seizures and hallucinations). Healthy volunteers are used because you dont want the effects of a disease to complicate the assessment of drug activity, especially in Phase I trials. Animals dying during testing isnt a reason to not test on humans per se. Toxicity testing is performed on animals long before human tests begin, to establish a toxicity profile. They volunteered and were paid - what happened is one of the risks involved. |
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not exactly what I meant swing, but now that you said it, I can agree with your resoning in dealing with this subject. |
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Coming from one that works in the research field, take it from me that these drugs are tested on people in clinical trials that meet the criteria of the study, and not nessicarily the symptoms of the disease that the drug is supposed to treat/cure. One thing I found out fast when I started working in the research field is that ethics and morality are ambiguous at the best. The topic of this thread is case and point. |
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Clinical Trials in the US involve many years.
New Drug design, lab based testing on computer models, living cells, etc. Animal Testing. Testing On HEALTHY, DISEASE free individuals (to examine for side effects)****That is where these guys probably were on the testing, assuming the UK uses the FDA model. Testing on Limited Numbers of People with the disease (normally with minimal existing pathology). Testing on Large Numbers of People with the disease (with a wide variety of problems). Approval of the Drug-- Even after there is approval, there is an Adverse Drug Event reporting REQUIREMENT that all health care practitioners must report known drug problems. Each stage above can take 1-3+ years. Even so--look at Vioxx as a recent example. Worked pretty well for what it was designed to do. Long term use caused some complications (basically raising the Blood Pressure by 5-10 points--which caused an increase in the number of problems with stroke, heart attacks, etc). The company stands to lose BILLIONS of $$ in lawsuits for a drug that met the testing requrements. I still have some samples here--works GREAT on headaches and bad muscle aches and pains. People fail to realize that NO drug is without side effects, even the Placebos used in testing have some reported side effects. Drug Companies get sued all the time for issues with their drugs, so of course they aren't going to circumvent the FDA approval process (yes, there are a few exceptions--however, in ANY industry there are people that will do that...look at Enron, etc.). Yes, it is sad what happened to these guys, however, they DID sign off on a consent form, that would presumably include serious complications & death. The fact that the Media ran amok on this, and ambulance chasers are probably coming out of the woodwork because of it, doesn't necessarily mean the Drug Company did wrong. I still reserve judgement on any blame until I find an unbiased source with full details. AFARR PS--are they called Ambulance Chasers in England (Lorry Chasers, perhaps?). |
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Thanks for the clarification. I honestly had no idea people volunteered and were paid to be human guinea pigs. BTW, lawyers are called solicitors in England. |
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Before you guys pull out the violins, they GOT PAID. They knew the risks and they took it.
You use the meds on HEALTHY individuals to make sure it does not have any unwanted effects. If you use it on ill patients, you might not be able to tell if its the effect of the drug or the disease. Animals and people are not the same. They use chimps because they are the closest to us. Dont believe the media, I really doubt some pharm company would go to phase I trials without animal experimentation and trials. I think I know what we should de with the prisioners at Gitmo and AbuGrave. |
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No we don't or can't use monkeys, PETA may get mad. After all they have more rights then humans. |
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