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    raincoasterGabrielle Bluestone
    1/15/16 10:16am

    The Independent is saying it’s a cannabis-based, orally-administered painkiller. Which makes this all the stranger. I’d be looking at where the actual doses were prepared: a shady pharmacist, killer nurse, maybe something like that.

    http://www.independent.co.uk/news/world/eur…

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      eliezabethraincoaster
      1/15/16 10:20am

      Agreed. This reeks of a deliberate act or contamination. NOT just a dangerous drug.

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      Street Sweeperraincoaster
      1/15/16 10:22am

      It’s almost certainly a synthetic cannabinoid rather than truly being “cannabis based”.

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    youreahotmessGabrielle Bluestone
    1/15/16 10:09am

    I know drug companies get a lot of hate, but it is really strange for something like this to happen in Phase 1, 2 or 3 of drug trials. I mean you have to develop a drug normally for about 10 years before you are able to test on healthy humans. And that normally means testing on animals years before Phase 1, but maybe that system is different in the EU.

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      eliezabethyoureahotmess
      1/15/16 10:11am

      This strikes me as something other than just a drug reaction. Contamination, deliberate act, but not just a normal trial.

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      Grim3youreahotmess
      1/15/16 10:20am

      I wonder if it was administered incorrectly or contaminated. I know nothing about drug testing but I guess I am surprised it doesn’t happen more. Is the range of things that are toxic to humans and but not animals so small? And many of the drugs that we take are toxic at large dosages. Is it easy to nail down what a non-toxic dosage would be with animals?

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    cooterbaldwinGabrielle Bluestone
    1/15/16 10:10am

    ...with one patient confirmed brain dead.

    So someone made a drug to turn people into Trump supporters?

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      Ossmidcooterbaldwin
      1/15/16 10:16am

      Isn't it pretty much a given that if you're dead, you automatically become a registered democrat.

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      thgyhgbcooterbaldwin
      1/15/16 10:22am

      holy shit hahahahahahahahahahahahahahahahahahahahahahaha!!!!!!!!!!!!!!!!!!!!!!

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    CleverUsernameGabrielle Bluestone
    1/15/16 10:41am

    “Clearly this is an example of how governments are incapable of regulating the pharmaceutical industry. Let’s dissolve the FDA.”

    -GOP

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      bubbajoe123456CleverUsername
      1/15/16 12:59pm

      No, no, that argument only applies to GUNS.

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      j4x_bubbajoe123456
      1/15/16 1:50pm

      Multiple Republican presidential canidates are on record wanting to defund, limit or abolish the FDA outright (along with the CDC and EPA). It is one of the most clear signs they are divorced from objective reality.

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    IAMBlastedBiggsLostBurnerGabrielle Bluestone
    1/15/16 10:19am

    Somehow or another, they should tie this to Martin Shkreli. Fake evidence, bribe investigators, do whatever they have to do, but it should happen.

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      CaDiPMEIAMBlastedBiggsLostBurner
      1/15/16 10:43am

      Then film it and sell it to Netflix! The country will be enthralled!

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      IAMBlastedBiggsLostBurnerCaDiPME
      1/15/16 10:46am

      But, in an amazing twist *OMG SPOILARRR ALERT* the investigators and prosecutors are the ones everybody's pulling for!

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    raincoasterGabrielle Bluestone
    1/16/16 4:43am

    This is scary: The Guardian reports it had only been tested on animals since JULY. That’s nowhere near enough time!

    http://www.theguardian.com/world/2016/jan…

    Touraine said the drug was a so-called FAAH inhibitor meant to act on the body’s endocannabinoid system, which deals with pain. Earlier reports suggested that the drug contained cannabinoids, an active ingredient found in cannabis plants, but the minister said it did not contain the drug or any derivatives of it.

    Touraine said the study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”.

    Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase one entails a small group of volunteers and focuses only on safety. Phase two and three are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount.

    Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said.

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      King Podrick, First of His Name, Tamer of Erogenous Zonesraincoaster
      1/20/16 12:01pm

      I’m betting they totally fudged the animal testing. I don’t believe there could be no warning signs in chimps with even the slightest bit of testing.

      Add this to the list of increasing evidence that synthetic cannabinoids are among the most dangerous drugs out there, and we have very little understanding of them. I remember a time when soldiers in the US were doing synthetic cannabis in large numbers and no one knew how dangerous the stuff was. Now we’re finding that it’s as addictive as heroin and meth with possibly faster deterioriation in users, longer lasting mental and physiological effects, and a withdrawal profile that is something like a combination of heroin, meth, and some other shit.

      I bet they create something that is just as addictive as opiates but less effective and more dangerous, and market it like a safe and healthy alternative.

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      raincoasterKing Podrick, First of His Name, Tamer of Erogenous Zones
      1/21/16 4:51am

      Yeah I always thought the animal testing phase included at least one full term pregnancy. It’s just an OBVIOUSLY good idea.

      Strange we haven’t heard anything since the night the story broke, though. Very strange and worrying.

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    TimF101Gabrielle Bluestone
    1/15/16 10:45am

    So this scanned green in all the animal testing, and then wrecked the first round of human subjects? Bull crap. Of all the things that could have gone wrong here, I would bet that someone fudged data in the animal trials. Formulation errors or intentional sabotage would be vanishingly unlikely, whereas it is so easy to get caught up in the internal hype about a new product. The pressure to produce positive results can get intense.

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      lilbobbyTimF101
      1/15/16 12:28pm

      The drug had been administered to 90 people during the trial, according to the Times article. As far as I can tell, this accident occured over the weekend and it seems (as of right now) that only the latest batch of volunteers were affected. Very strange indeed.

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      TimF101lilbobby
      1/15/16 1:41pm

      Ooooh. In that case it sounds like a formulation screwup.

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    Sia's Oversized WigGabrielle Bluestone
    1/15/16 10:02am

    I’m trying to think what recourse one would have in this situation. I’m assuming you sign a waiver that you are aware of any possible risk, so can they even sue? How does it work in France?

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      bonjour tristesseSia's Oversized Wig
      1/15/16 10:10am

      U.S. citizen, so I can’t speak to the specifics. But I was in a drug trial when I was a poor college student and basically had to sign my life away.

      On the plus side, it was a trial for an HPV drug. I tested negative for HPV (yay!) and was sent packing after one visit, never having to take any questionable drug, and with a $500 check.

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      Raging BulldogSia's Oversized Wig
      1/15/16 10:11am

      In the US you sign a very long consent form. The institution performing the trial is responsible for any medical care required that’s associated with the trial. I don’t work with drug trials though, so I’m probably leaving out some information.

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    MrSmartypants123Gabrielle Bluestone
    1/15/16 10:04am

    You can pretty much say that phase 1 has been concluded.

    <note in chart>“Drug is not safe.”</note in chart>

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      Jujymonkey3MrSmartypants123
      1/15/16 10:23am

      “Pleasant taste. Some Monsterism”

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    ThrumbolioGabrielle Bluestone
    1/15/16 10:42am

    “We meant to administer doses of our new treatment, but goofed and just threw a bunch of Drano in there. The weird thing is that Destop would have worked perfectly fine in this instance.”

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