1 man brain dead, 5 others hospitalized in French drug trial

[Ecoclimber]

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:

 

[svetoslav80]

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

 

[Gingergrrl]

Just read the article, how horrible.

 

[IreneF]

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.

 

[roller]

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]

 

[CFS_for_19_years]

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

The prosecutor’s office has opened an investigation into what French Health Minister Marisol Touraine called “an accident of exceptional gravity” at the private Biotrial clinical lab in Rennes
[.......]
The chief neuroscientist at the hospital in Rennes, Professor Gilles Edan, said in addition to the brain-dead volunteer, three others could have “irreversible” brain damage. A fifth man is suffering from neurological problems and a sixth volunteer is being kept in the hospital but is in a less critical condition, he said.

Edan said there’s no known treatment for the experimental drug that Biotrial was testing. The drug was a based on a natural brain compound similar to the active ingredient in marijuana.

Touraine said the medication was not based on cannabis, as some media reports had claimed. She urged calm, saying that no drug currently on the market was implicated in the failed trial. She said the drug was produced by the Portuguese pharmaceutical company Bial, which said Friday it had no comment on the failed trial at this time.

 

[roller]

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

Fatty acid amide hydrolase or FAAH is a member of the serine hydrolase family of enzymes. It was shown to break down anandamide. In humans, it is encoded by the gene FAAH.[2][3][4]

FAAH knockout mice display highly elevated (>15-fold) levels of N-acylethanolamines and N-acyltaurines in various tissues. Because of their significantly elevated anandamide levels, FAAH KOs have an analgesic phenotype, showing reduced pain sensation

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

Anandamide has been shown to impair working memory in rats.[7]

 

[roller]

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

JANUARY 15, 2016 | NEWS
News Release
As part of a clinical trial that was being held in a Phase 1 clinical trial unit in France, since June 2015, with an experimental molecule of BIAL, we were informed that five participants showed severe symptoms. Following the best international medical practices, they were immediately transferred by the company responsible for conducting the clinical trial to observation at the University Hospital of Rennes, being currently under permanent medical supervision.

https://en.wikipedia.org/wiki/BIA_10-2474

BIA 10-2474 is an experimental FAAH enzyme inhibitor[1] developed by the Portuguese pharmaceutical company Bial. The drug was developed to relieve pain,[2][3], to ease mood and anxiety problems, and to improve movement coordination linked to neurogenerative illnesses.[4] It interacts with the human endocannabinoid system.[5][6]

FAAH inhibitors have been proposed for a range of nervous-system disorders including anxiety, alcoholism and pain.

Bial holds several patents on FAAH enzyme inhibitors.[13][12]

Prior to the clinical trial, the drug was tested on animals, including chimpanzees.[4]

In the third stage of the trial evaluating multiple doses, six male volunteers received such multiple doses starting January 7, 2016.

This means, 100% of the volunteers fell sick?

 

[lansbergen]

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]

 

[roller]

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.