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French Drug Trial Leaves One Brain Dead and Five Critically Ill (theguardian.com)
jones_supa writes: One person is brain dead and five others are seriously ill after taking part in a phase one drug trial for an unnamed pharmaceutical firm at the Biotrial clinic in France. In medicine, 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. The French health ministry said the six patients had been in good health until taking the oral medication. It did not say what the new medicine was intended to be used for, but a source close to the case told AFP that the drug was a painkiller containing cannabinoids, an active ingredient found in cannabis plants. Mishaps like this are relatively rare, but in 2006 six men fell ill in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia. All trials on the drug at the French clinic have been suspended and the state prosecutor has opened an inquiry.
Waiting for all the morons to blame cannabis. It's Friday, work's done, I'm stoned. Love you all x
>> 1 dead 5 wounded in a drug trial
That's why they call it a trial and limit who can be in it (so it's not 1,000 dead and 5,000 wounded).
"the drug was a painkiller containing cannabinoids" the french ministry of health says no cannabinoids was involved:
http://www.liberation.fr/franc...
The drug is about treating anxiety.
You know the other 2 are suddenly REALLY happy they got the placebo
The only thing necessary for evil to triumph is for it to be pitted against a slightly greater evil
with Arsenic.
I'm guessing this one isn't going to make it to market?
I thought it went "Blame Canada".
But if it was natural cannabinoids we have to "congratulate" the lab for producing something deadly from a relatively benign plant...
Also, I am curious how this can happen. Before starting such trials they are supposed to give huge doses of the "new" stuff to some unfortunate non-human mammals. I didn't know there could be a fatal compound that is non-fatal for e.g. rats in larger doses (if it was, it would have raised many flags I assume).
Violence is the last refuge of the incompetent. Polar Scope Align for iOS
They should be all over this. Testing drugs on humans must be stopped!
I am always surprised they find people who willingly participate in drug trials, especially for something like a painkiller. Do we really need ANOTHER painkiller on the market?
I am keeping an eye on these things as a chronic pain patient who is prescribed cannabis, but I am not 100% sure exactly WHICH drug this is about... It might have been BIA 02-093, aka Eslicarbazepine, from looking at earlier trials for painkillers by this company. Anyone know for sure?
"Those who do not understand Cannabis are doomed to reinvent it, poorly." - Heavy Vaper, 2016
Were they testing drugs to be used for the death sentence??
This is a pretty interesting reminder that many drugs' mechanism of action aren't fully understood. Even those that are well known operate solely by suppressing or enhancing some specific chemical reaction chain, so in reality they're pretty blunt tools. It's really interesting to think about the drug discovery process; everyone assumes that they at least won't die if the drug has made it to human trials, but apparently that's not the case!
I know know, terrible insensitive joke.
basic english fail:
volunteer means to freely offer, NOT necessarily to offer without compensation, hence a volunteer can be paid, and often is (volunteer firefighter, eg)!
Typical thing you expect from nanny-state socialists. No incentive to do things right.
--
roman_mir
According to French website Figaro,
ces essais de phase 1, après avoir été menés sur des chimpanzés, ont débuté le 9 juillet 2015 dans les locaux de Biotrial. 128 hommes et femmes participent aux essais. 90 personnes se sont vu administrer cette molécule à des doses variables, les autres ont pris une dose placebo, a indiqué la ministre.
"This phase-1 test, after having been done on chimpanzees, started on July 9 2015 at Biotrial. '128 men and women participated in the test. 90 of them were administered the molecule at different doses, while the others took placebo', said the minister (of Health, Marisol Touraine)"
I thought phase 1 is always on animal.... no?
You can compensate a volunteer and still have them be considered a volunteer. What the hell are you talking about?
The military in any country which doesn't have mandatory service is a "volunteer army". But they sure as hell get paid for it.
You're making up a definition of volunteer which isn't real in this case.
Lost at C:>. Found at C.
Do they do animal testing with drugs like this on chimps or monkeys to ascertain this kind of safety ahead of time before giving it to humans?
I would imagine they might have given it to rats just to make sure they didn't fall over dead immediately, maybe dogs, too, but I would expect that chimps would have a brain structure more similar to humans and might have been more revealing in safety of a drug like this.
I can appreciate where some chimp experiments might be a bit harsh, but a pain killer that you have good reason to think might work and might relieve pain would seem to be on the lighter side of animal testing and certainly better than dead humans.
In the states, we have pharmaceutical ads on television that are usually suffixed with a chyron or various disclaimers and a string of long-winded and frankly quite mumbly side effects all played over the backdrop of a beautiful sunset or a babbling brook. As someone whos worked in pharmaceuticals in the past, the biggest favour you can do for yourself when watching one of these commercials is to suffix your own side effect onto the drug at the end, one they often refer to mention. "Or death."
Good people go to bed earlier.
All EU citizens are willing to give their lives for the greater glory of Europe!
Fuer Europa! Heil Europa! Wir essen das Scheisse fuer dich!
Wait a minute. I supposed to believe that something went wrong at a European health facility filled with European doctors educated in European medical colleges because of a European pharmaceutical company?
News flash, people! France isn't in the United States!
Stop sexism in STEM! Why is there no gender parity in drug testing?
420
Waiting for all the morons to blame cannabis.
API: Dozens of school children were murdered by a deranged gunman in YourCity, USA earlier today. Governor Dumbshit (R|D) deplored the loss of life, but reminding voters that "at least we can rest easy in the knowledge that the gunman's second amendment right to bear arms was in no way abridged." Early reports that the bullets contained cannabis, and that medical marijuana lies at the heart of the tragedy, have been debunked, although Governor Dumbshit (D|R) has promised voters a thorough investigation "to get to the real facts." After wiping drool from his chin, the Governor went on to say, "If cannabis bullets weren't responsible for the loss of life, then why did investigators feel the need to deny cannabis was involved? Clearly, where there's smoke, there's cannabis."
The Future of Human Evolution: Autonomy
basic english fail:
volunteer means to freely offer, NOT necessarily to offer without compensation, hence a volunteer can be paid, and often is (volunteer firefighter, eg)!
Unless these people are independently wealthy and have no need for money, they are not "freely offering". If you entice someone to do something with cash that they need or want, they are not volunteering, it's an exchange of goods or services -- they are offering their body for money.
If people aren't doing it for the money, then why do they get paid?
"Just fix the fucking leak already, you blind bastard."
D.Troi, ST:TNG Thine Own Self
Confucius say, "Find worm in apple - bad. Find half a worm - worse."
Somebody on the street suggested that these need to be provided to a majority of the politicians. I think that is an extreme, although it may solve a lot of problems.
If you want to outlaw pot, fine. But stop calling it Cannabis derivatives, the biggest one is probably Dihydrogen Monoxide (yes H2 fucking 0*), which has health advantages taken internally.
You want an easy high? Fine, Smoke some herb. You want medicine, go through birch, valerian root, Isolate it like a professional and call it what it is.
*Yes I did that on purpose.
Thus proving time and time again that mouse biochemistry != human biochemistry. "But it was working fine in the lab!"
Seven puppies were harmed during the making of this post.
You are right, it's not about eslicarbazepine (BIA 02-093).
Instead, this appears to be a FAAH inhibitor named BIA 10-2474.
The drug in question appears to be a FAAH inhibitor named BIA 10-2474.
Any secondary indications after death?
It may still work.. patience.. .patience..
This is why vaccines are bad.
You can compensate a volunteer and still have them be considered a volunteer. What the hell are you talking about?
The military in any country which doesn't have mandatory service is a "volunteer army". But they sure as hell get paid for it.
You're making up a definition of volunteer which isn't real in this case.
In the general sense, volunteers are not compensated:
Volunteering is generally considered an altruistic activity where an individual or group provides services for no financial gain. Volunteering is also renowned for skill development, and is often intended to promote goodness or to improve human quality of life. Volunteering may have positive benefits for the volunteer as well as for the person or community served.[1] It is also intended to make contacts for possible employment. Many volunteers are specifically trained in the areas they work, such as medicine, education, or emergency rescue. Others serve on an as-needed basis, such as in response to a natural disaster.
Military volunteers are a special case:
A military volunteer is a person who enlists in military service by free will, and is not a mercenary or a foreign legionnaire. Volunteers often enlist to fight in the armed forces of a foreign country. Military volunteers are essential for the operation of volunteer militaries.
Seriously,,
this is so lame, but expected from the uninformed minds at DHI.
by leaking some of the key ingredients, you now taint the story..
I hope this does not turn into a pot hating exercise..
Considering this has to be one of first chemicially induced death from a pot by product, I have to wonder..
Was it prepaired correctly? What were the other ingredients?
How was it administered?
Were the drugs tested before dossages were given, to ensure they were kept right (right temp, away from light, etc..)
We can prevent this from happening again if we eliminate the onerous regulatory requirements to perform drug trials.
(note: joke)
Wrong. In an army, volunteers generally means those who are not conscripts. But both get paid.
You may want to google for terms like "false dichotomy".
Confucius say, "Find worm in apple - bad. Find half a worm - worse."
"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."
Wrong. In an army, volunteers generally means those who are not conscripts. But both get paid.
You may want to google for terms like "false dichotomy".
I don't see the false dilemma - except for the few that are willing to sacrifice their health for the greater good without compensation, what do you think motivates "thousands of students looking to make money" to "volunteer" for medical experiments? Do you think those thousands of students would do it if not for the money?
Why is it so bad to just say what it is -- people getting paid to take on health risks for the benefit of others? No need to whitewash it and say that they all "volunteered" when they are really just there for the money.
That's tough.
I'm not often in favor of more legislation, but here's something that should be required for
any type of drug trial on humans.
A mandatory, independently facilitated pre-mortem where everyone from R&D and other involved teams gets their say on possible dangers. Anonymously.
https://en.wikipedia.org/wiki/Pre-mortem
So you think people have no agency in deciding how they want to earn money? That is stupid.
Most ACs are not even worth the keystrokes to insult them. Be generically insulted by this and ignored otherwise.
OK, here's an idea that's slashdot-worthy: Hire your Bill-Murray-in-Wild-Things-type shyster lawyer, sue the company on behalf of the braindead guy for millions (francs though, take it or leave it) and spend the rest of your life touring your bucket list (although your master lying down in the back of the stretch limo won't be the whiner/complaining type simply because he's dead. I hope I wasn't going too fast for you...
Remember kids: There is no OFF position on the genius switch
WARNING: Smartphones have side effects--most of them undocumented.
I mean, come on. Here in the U.S. when we have drug trials, though the pharmaceutical companies do there best to dazzle the jury with their $1,000.00 per hour lawyers, we don't bore them to death. I mean seriously, a trial left jurors dead and in critical condition? That's some real jurisprudence if you ask me!
Here we go again.You're trying to minimize peoples agency so you can justify some government intrusion that makes these decisions for them. Go away statist.
I thought this was going to be about a pharmaceutical company getting sued.
"Consistency is the Hobgoblin of small minds but Specialization is the ruination of all minds" Leonardo's Law
And there's the root of your false dichotomy: "For no financial gain" != "Not compensated".
Il n'y a pas de Planet B.
And there's the root of your false dichotomy: "For no financial gain" != "Not compensated".
Which is the root of my argument that the pharmaceutical "volunteers" are not really volunteers, since they receive financial compensation.