The 12th Invest in ME Research Conference June, 2017, Part 2
MEMum presents the second article in a series of three about the recent 12th Invest In ME International Conference (IIMEC12) in London.
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1 man brain dead, 5 others hospitalized in French drug trial

Discussion in 'Other Health News and Research' started by Ecoclimber, Jan 15, 2016.

  1. Ecoclimber

    Ecoclimber Senior Member

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    :jaw-drop: Wow! Something went horribly wrong in this clinical trial.

    PARIS (AP) -- One man was brain dead and three others faced possible permanent brain damage after volunteering to take part in a drug trial for a painkiller based on a natural brain compound similar to the active ingredient in marijuana, French authorities said Friday.

    The Paris prosecutor's office opened an investigation into what French Health Minister Marisol Touraine called "an accident of exceptional gravity" at a clinical trial lab in the western French city of Rennes. More:
     
  2. svetoslav80

    svetoslav80 svetoslav80 at gmail.com

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    This is awful. I just heard on the news about the unfortunate trial.
     
  3. Gingergrrl

    Gingergrrl Senior Member

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    Just read the article, how horrible.
     
  4. IreneF

    IreneF Senior Member

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    This was a phase one trial and the drug had already been tried on primates, which would have been on a controlled diet. I wonder if there was some unknown interaction between this drug and other drugs or food. My husband has a list of food restrictions because of a medication, I can't drink grapefruit juice, and interactions between narcotics and alcohol are well known.
     
  5. roller

    roller wiggle jiggle

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    Despite news reports, Cannabis is not an ingredient in the tested med.
    The compound is supposed to act on mood swings, motoric dysfunctions and neurodegenerative disorders.

    90 volunteers received the test med, which was developed by Portuguese pharmaceutical Bial.

    The test under control of french Biotrial started on Jan 7, on Jan 10 the first volunteer showed symptoms. he is now brain dead on the intensive care station.

    The four victims, some supposed to have irreversible brain damage, were males between 28 and 49, who had taken the med multiple times before showing symptoms.
    one of the volunteers shows no adverse symptoms, but is under watch in hospital.

    as in test phase 1, which the first test on humans, all dosages are super-low, everyone is puzzled by such an extreme outcome of the trial.

    [unclear why one is explicitely mentioned, while 86 had also had no adverse reaction]
     
    Last edited: Jan 16, 2016
  6. CFS_for_19_years

    CFS_for_19_years Hoarder of biscuits

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    http://www.columbian.com/news/2016/...drug-trial-leaves-1-brain-dead-5-in-hospital/

     
  7. roller

    roller wiggle jiggle

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    On Sunday Jan 10 the first patient was diagnosed with a stroke, explains Gilles Edan, Head of the Neurology Department of the University Hospital Rennes at a press conference. The patient was administered a blood thinner. According to Edan either brain cells died or brain hemorrhages occurred.

    Another problem is the novelty of the drug and its ingredient. Doctors have no idea how to deal with the side effects. They are giving Corticosteroids in the hope to reduce the brain inflammation.

    "Their condition has deteriorated in the first days of this week." Four of them have different severe neurological problems. In three of them permanent damage is feared. Cerebral hemorrhages were detected and nerve tissue is destroyed, according to Gilles.

    Bial confirms using "experimental molecules" in the tested drug. Several French media report, the substance was BIA 10-2474, listed in Bials drug pipeline.

    The active ingredient of BIA 10-2474 is a so-called FAAH inhibitor that is required to regulate the perception of pain. FAAH degrades endogenous substances which can act similar at the cannabinoid receptors as THC does, the active ingredient of cannabis. To enhance the effect of these endogenous substances, BIA 10-2474 inhibits their degradation by FAAH. In this way, pain, mood swings and fears should be alleviated, as Health Minister Touraine. The drug should be used also against neurologically induced movement disorders, such as Parkinsons.


    from the dailymail:
    The minister said the drug was meant to act on the body's endocannabinoid system, which deals with pain.


    https://en.wikipedia.org/wiki/Fatty_acid_amide_hydrolase
    https://en.wikipedia.org/wiki/Anandamide
     
    Last edited: Jan 16, 2016
    funkyqueen likes this.
  8. roller

    roller wiggle jiggle

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    https://www.bial.com/en/pressroom.138/news.140/news_release.a554.html

    https://en.wikipedia.org/wiki/BIA_10-2474
    This means, 100% of the volunteers fell sick?
     
  9. lansbergen

    lansbergen Senior Member

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    https://en.wikipedia.org/wiki/Anandamide

    Anandamide, also known as N-arachidonoylethanolamine or AEA, is an essential fatty acid neurotransmitter derived from the non-oxidative metabolism of eicosatetraenoic acid (arachidonic acid) an essential ω-6 polyunsaturated fatty acid. The name is taken from the Sanskrit word ananda, which means "joy, bliss, delight", and amide.[1][2] It is synthesized from N-arachidonoyl phosphatidylethanolamine by multiple pathways.[3] It is degraded primarily by the fatty acid amide hydrolase (FAAH) enzyme, which converts anandamide into ethanolamine and arachidonic acid. As such, inhibitors of FAAH lead to elevated anandamide levels and are being pursued for therapeutic use.[4][5]
     
  10. roller

    roller wiggle jiggle

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    Biotrials CEO François Peaucelle confirms "full transparency" in the cooperation with the investigators.

    On the tragic outcome of the trial he spoke of "unforeseeable, unsolved and unexplainable events".

    When the patients fell sick, the current intake was still far off the planned max intake, Peaucelle said.

    The 128 volunteers of the trial, 90 of them were medicated, and only the 6 receiving multiple dosages feel sick, were paid about Euro 1,000 per week for participating.

    The brain dead volunteer has been declared dead on Sunday 17.
     
    Last edited: Jan 18, 2016

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