Drug Trial Goes Horribly Wrong

Two men are in critical condition and four are seriously ill after partaking in a clinical drug trial.

BBC reports, “But relatives are said to be unhappy with the information given from the firm behind the anti-inflammatory drug.”

“Ms Marshall [pictured], 35, whose boyfriend is critically ill, said the normally healthy 28-year-old’s face was so puffed, he “looks like the Elephant Man”.

Soooo, it’s an anti-inflammatory drug and his body is badly swollen… that would strike us as humorously ironic if we weren’t so busy crying.

“Lawyer Ann Alexander, representing one of the critically ill men, told the BBC the companies had been asked whether any of the animals used to test the drug had died.

“I understand that yesterday, they were told a dog had died during the testing. Today that was denied,” she said.”

Right, so if a pooch dies during testing, that’s usually a pretty good sign that the drug isn’t ready for human use.

“A day ago I was talking to him and he was fine and now they are saying he could die at any moment,” said Ms. Marshall.

From The Independent:

    “One victim was named as trainee plumber Ryan Flanagan, 21, of Highbury, north London. His family were told he could not breathe unaided, and his head and neck had swollen to three times their normal size.”

    “Raste Khan, one of two men taking a placebo who was unharmed, said his co-subjects “went down like dominoes”. He told The Sun: “First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode. After that they started fainting, vomiting and writhing.”

    A former student described yesterday how he nearly took part in the Parexel trial but dropped out of it.

    But he felt rushed. ”Something told me to be suspicious about it even though I did not know why I should,” he said. ”It seemed a bit haphazard.’”

Two Drug Trial Men Critically Ill [via Digg]

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  1. airship says:

    Much as I hate drug companies, I am alive today because of the research they do. I doubt seriously they were trying to kill anyone. Not because they are so moral or anything, but because there’s no money in it. Drug testing is inherently dangerous, and I hope that no draconian regulations are implemented because of this. I’m sure I’m going to be needing even more drugs in the future to keep my sad, overweight carcass alive, and I’d hate to drop dead just because drug companies are unduly hindered from testing new drugs. That being said, I really feel sorry for these guys and their families.

  2. Ben Popken says:

    Jane writes:

    Hi,

    I jut thought you’d be interested in this post, written by a British blog that covers medical and drug-related topics occasionally.
    http://www.blacktriangle.org/blog/?p=1306

    It’s a fairly reasoned argument on aspects of the whole drug trial issue. While I understand you guys are interested in keeping consumers informed, your coverage of the topic at this time (10:38 EST) leaves the impression the drug company knowingly injured drug testers. Clearly it isn’t in the best interests of pharmaceutical companies to kill people, since dead people buy fewer drugs.

    Pharmaceutical companies do awful things, I can go on for hours, but I don’t think they would have been allowed to run clinical trials if they had known about the reaction the drug would cause in humans. There’s also an interesting interview with one of the men who recieved the placebo in the study, here: http://news.bbc.co.uk/1/hi/health/4813478.stm

    Jane

  3. Nick says:

    Certainly they weren’t _trying_ to kill anyone, but I don’t think it’s out of the question that they may have been less then thorough in their procedures leading up to testing. When there’s commercial pressure to get something to a marketable state as soon as possible, there’s always the temptation to cut corners, and I’m sure speeding up the timeline for human testing without finishing exhaustive tests on animals first is one way to do that.

    From at least one article I’ve read, the experimental procedure wasn’t ideal, either – they gave the doses to all the test subjects at the same time, even though the pre-eminent textbook on the subject strongly advises staggering trials for exactly this reason – if the outcome is catastrophic, the minimum of people are exposed to it.

  4. Paul D says:

    Clearly it isn’t in the best interests of pharmaceutical companies to kill people, since dead people buy fewer drugs.

    This is the same bullshit reasoning given by tobacco apologists. The truth is that the companies don’t think that far ahead. They’re in it for the dollars they can make off you now, and if you die…there’s always your kids.

  5. kerry says:

    Pharmaceutical companies do awful things, I can go on for hours, but I don’t think they would have been allowed to run clinical trials if they had known about the reaction the drug would cause in humans.

    Not so fast … the makers of Vioxx, Celebrex and Bextra (those last two are the same company) knew from human trials that their drug could cause heart disease in the elderly, but the drug still got past the FDA. There’s a big difference between knowing about a problem and making that data public. If the drug company in this case knew that their drug had killed a few dogs, but had reason to believe it was not drug related they could easily suppress that information and go on to human trials, in an effort to bring their drug to market (and profitability) faster. They take a chance and play the odds that a few dead dogs won’t translate to a few dead people.