[gatagato]

One person has been left “brain-dead” and five more have been hospitalised after a clinical trial on an experimental drug went wrong in France.

The health ministry said the “serious accident” happened on Thursday, stopping the tests and forcing all volunteers to be recalled.

A statement released today did not confirm the name of the drug being tested but French media reports claimed it was a new cannabinoid-based painkiller.

Marisol Touraine, the French health minister, later said that the pill did not contain cannabis or its derivatives but acted on the body's endocannabinoid system.

Taken orally, the drug was undergoing a Phase 1 clinical trial at a licensed private European laboratory that specialises in clinical trials, the French health ministry said.

The trial aimed to evaluate the “safety, tolerance and pharmaceutical properties of the molecule” in healthy volunteers.

“Marisol Touraine wants to express her solidarity and deep determination to get to the bottom of what happened and establish responsibility for this tragic accident,” a statement added.

One of the six volunteers is currently in intensive care at Rennes University Hospital, where the other five are also being treated.

France’s medicines agency (ANSM) has launched an investigation into the laboratory.

http://www.independent.co.uk/news/wo...-a6813791.html

[CrunchyCripple]

Oops!
Didn't test it on enough rats, I guess.

[Steve]

I should imagine they signed a waiver if anything went wrong. I know you can be well paid for this type of thing, but I don't live in a cage, eat lots of cheese and squeak a lot.

[b0g]

1900 € for 1 dose for 14 days

the endo canna system in the brain can be over stimulated. this causes lowered pain experience, but also low to very low consciousness. app. the folks with the highest dose got to the vegetable state. too little oxygen in the brain for too long . And you're a vegetable or heaven candidate.

[b0g]

also French Biotrial did the tests. The drug is prop of Portuguese firm Bial.

[Pink.]

Originally Posted by CrunchyCripple ↗

Oops!
Didn't test it on enough rats, I guess.

True that....

AND there has ALWAYS been issues with anything that hits or AALLEGEDLY hits the receptors that cannibas hits...

anxiety/nausea/pain.

We have had kids ospitalized for the street stuff and now this...IT SEEMS THEY WOULD HAVE LEARNED AFTER YEARS OF FAKE MARIJUANA OF ANY KIND.....JUST GIVE THE REAL THING AND DONT KILL PEOPLE.

[Oswald2001]

Originally Posted by Pink. ↗

True that....

AND there has ALWAYS been issues with anything that hits or AALLEGEDLY hits the receptors that cannibas hits...

anxiety/nausea/pain.

We have had kids ospitalized for the street stuff and now this...IT SEEMS THEY WOULD HAVE LEARNED AFTER YEARS OF FAKE MARIJUANA OF ANY KIND.....JUST GIVE THE REAL THING AND DONT KILL PEOPLE.

Nope.

Too easy.

[Sharon]

I saw this in the news, how horrific

[CrunchyCripple]

One of the people died, or so it said on FaceBook.

[kellyhound]

Touraine, who visited the hospital today, said all six are men aged between 28 and 49 years old. She said the drug had been tested on animals, including chimpanzees, and that France's National Agency for Medicine and Health Products Safety (ANSM) approved the trial on 26 June 2015. The plan was to enroll 128 volunteers aged between 18 and 55; the trial would first test a single dose, then multiple doses, and finally the combination of the drug with a meal. So far, 90 people have received varying doses of the drug while others had received a placebo, Touraine said. (Phase I studies don't usually have a placebo group; it's not clear why this one did.)

The six volunteers that were hospitalized all received multiple daily doses, the first one of which was given on 7 January. The first symptoms appeared on 10 January, Touraine said, and the trial was halted the next day.

Touraine didn't speculate on why symptoms only appeared in this group and not in previous volunteers; it's possible that the six were the first to receive multiple doses of the drug, or that a batch of drug was contaminated in some fashion. (All six were "in the same trial group," Edan said.) Every volunteer who has taken the drug since the trial began will be contacted, Touraine said, presumably to be checked for any adverse events that might have gone unnoticed.

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.

Serious incidents in phase I studies are rare, but they can never be completely excluded because a drug's behavior in animals isn't always a good predictor of its effects in humans. The last publicly known similar incident occurred in 2006, when six men in the United Kingdom suffered severe organ dysfunction after receiving small doses of a monoclonal antibody named TGN1412.

would rather sleep in the gutter than volunteer to test meds for money.