Clinical Research Tragedy in France, One Man Brain Dead Others Hospitalized

More details emerge on fateful French drug trial

Well this is interesting... a private research company in Rennes France, called Biotrial, was conducting a Phase 1 clinical trial on a new chronic pain medication when it severely backfired. This is directly from Science, the world re-known academic science journal.

Meanwhile, the Portuguese pharmaceutical company that sponsored the trial, Bial, confirmed in a statement issued last night that the drug tested in the study was an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme that breaks down so-called endocannabinoids in the brain. FAAH inhibitors have been proposed as a possible treatment against chronic pain.

According to the document, the trial enrolled nonsmoking men and women aged between 18 and 55 who had a body mass index between 19 and 30. The plan was to give patients BIA 10-2474 every day between the third and thirteenth day of their stay at the clinic, while they underwent an extensive battery of tests and sampling—including as many as nine blood collections on some days. On the first and last day of drug administration, patients' heart rates were to be monitored around the clock while all of their urine was collected for analysis. (Between day 3 and 9, however, all they apparently had to do was take BIA 10-2474 and provide a single blood sample.) They were due to be released on 18 January but had to come back for a final check-up and more sampling on 1 February.

The effects were started to be seen after the third day, and the trial was halted after the fourth after all 6 people had to become hospitalized. The trial was slated to last for 10 days and although the drug had been administered in the past, it was not given at this level of frequency and dosage. It was also given to animals including chimpanzees with no drastic side effects.

The study was halted on Monday, and all six patients who had taken the drug were hospitalized; one is brain dead, four others have neurological symptoms of varying severity, while one is under observation but without symptoms, neurologist Gilles Edan of the University of Rennes Hospital Center said yesterday. MRI imaging has shown "deep, necrotic and hemorrhagic lesions in the brain" of the patients, Edan said.

Talk about bad luck and I can definitely feel for those involved! They took a chance in helping the medical community by participating in a phase 1 clinical trial (along with making a few bucks) and how they are being hospitalized for severe brain hemorrhaging. Yikes!


The original story can be found here: www.sciencemag.org... ow-so-far-about-clinical-trial-disaster-france

Touraine said that prosecutors in Rennes have opened an investigation and that ANSM will conduct an investigation as well. Meeting the victims and their families today was "a moment of intense emotion," Touraine said. "The shock is even greater because people who participate [in phase I trials] are healthy, not sick, and obviously they don't expect to be confronted with such accidents."

Phase I studies are designed to test safety and tolerability of a drug, as well as how, and how fast, the chemical is processed by the human body. Most of these studies are carried out by specialized research contract companies; the subjects are usually healthy volunteers who receive modest financial compensation.

a reply to: charolais

I think that playing with the endocannabinoid system using synthetic drugs instead of what nature provided and making various extracts from that, if necessary is doomed to stupid failure.

originally posted by: LightSpeedDriver
a reply to: charolais

I think that playing with the endocannabinoid system using synthetic drugs instead of what nature provided and making various extracts from that, if necessary is doomed to stupid failure.

I found it interesting they were studying the endocannabinoid system. Goes to show the medical industry might know more than they want to admit about cannabinoids (although most on ATS probably already assume that...)

a reply to: charolais

synthetics versus naturally-created cannibinoids are a whole 'nother ballgame.

That "synthetic" weed has been shown to cause deadly side effects in people. Natural cannabis, never once. And now they want to introduce genetically modified (GMO) cannabis. ugh, so sad. stick to organics and you won't have any issues

This is a dreadful occurrence.
There's obviously been a major cock-up in pre-clinical testing that has gone unnoticed.

a reply to: charolais

I found it interesting they were studying the endocannabinoid system. Goes to show the medical industry might know more than they want to admit about cannabinoids (although most on ATS probably already assume that...)

I found that interesting too. It seems the more they learn, the more they realize that cannabis and its cannabinoids are absolutely vital to our immune systems. I'm as sure as I can be that Big Pharma, the FDA, etc., all know that cannabis works best when used whole and its various cannabinoids and terpenes can work together to do their stuff.

But that's not patentable and controllable and -- most of all -- profitable. And, unfortunately, the laws not only allow but encourage and empower Big Pharma to do what is in THEIR best interests. Not OURS.

a reply to: FamCore

Any type of "hydro" IS a GMO, cross pollinated strains ARE a GMO, cheap mexican ditch weed is the natural variety. Ya know the seedy stuff??? Those pretty nugs with the hairs, those are man made strains.

originally posted by: sycomix
a reply to: FamCore

Any type of "hydro" IS a GMO, cross pollinated strains ARE a GMO, cheap mexican ditch weed is the natural variety. Ya know the seedy stuff??? Those pretty nugs with the hairs, those are man made strains.

Incorrect. Hydro, at least here in Holland, refers to a system of growing based on water and not soil. I will admit to ignorance what that term means in other countries.

"Crossing" does indeed yield hybrids, sometimes. Sometimes the plant is a "hybrid" itself, however it is not and never is "GMO" as you put it. It is natural selection. You want some Blueberry Haze? You cross the Haze with the Blueberry, two distinct strains, and sexes. Knock yourself out, it takes knowledge, space, time and illegal growing rooms. It does not contain tomato, fish and poison based gene splices.

If you want "pure", geographically isolated strains, google "land race cannabis seeds" but these rarely grow well outside of their normal environment without several years of expert conditioning by horticulturalists. A 12 week sativa in Holland will be a disappointment outside. Summer here is often not much, rarely more that 8 or 9 weeks if that. Good luck!

Just wanted to add, scientists have studied cannabinoid receptors for years and years and they aren't called cannabinoid receptors because cannibis and its constituents are the only things that target them. They have important, endogenous roles within the human body.

Tragic for those involved..Watch for Biotrial going into administration very soon.