French drug trial suspended after 1 brain death, 5 more in hospital, 3 brain damaged

Alessandra Kelley

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http://www.bbc.com/news/world-europe-35320895

One man is brain-dead and another five people are in hospital after an experimental drug was administered to 90 people in a French clinical trial.

The trial was a Phase I test for safety of an unknown drug (denied by the health ministry to be a cannabis-based painkiller) manufactured by the company Bial in Portugal and tested on healthy volunteers by Biotrial, a laboratory in Rennes.
 

ShaunHorton

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6 people out of 90. That's only 0.06%. I'm honestly surprised they're making this big a deal out of it. Especially with so many other drugs on the market already which list things like Stroke, Heart Attack, and even Cancer as possible side effects.
 

William Haskins

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6 people out of 90. That's only 0.06%. I'm honestly surprised they're making this big a deal out of it. Especially with so many other drugs on the market already which list things like Stroke, Heart Attack, and even Cancer as possible side effects.


add one more to the brain-dead, am i right?
 
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ShaunHorton

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Okay, so my math was off.

The rest of the comment still stands. We have drugs out there now which list everything from headaches to straight-up death as side effects. Not that it all isn't horrible, but why is this standing out?
 

Brightdreamer

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Okay, so my math was off.

The rest of the comment still stands. We have drugs out there now which list everything from headaches to straight-up death as side effects. Not that it all isn't horrible, but why is this standing out?

At a guess, someone screamed to the press, and the press was happy to play up the Big Evil Pharma Peddling Poison option. (Haven't had a good Big Pharma scare in a bit; mostly it's been xenophobia lately.)
 

Helix

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Okay, so my math was off.

The rest of the comment still stands. We have drugs out there now which list everything from headaches to straight-up death as side effects. Not that it all isn't horrible, but why is this standing out?


I'd imagine it's because those side effects are extremely rare in those drugs, but are extremely common in this one.
 

Xelebes

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Okay, so my math was off.

The rest of the comment still stands. We have drugs out there now which list everything from headaches to straight-up death as side effects. Not that it all isn't horrible, but why is this standing out?

Because 1/90 (1.11%) effectively died and another 5.56% are either in hospital care. This is a very serious case and there are only two other medical calamities like this in the last twenty years, I believe. Risk of death is usually kept much lower, preferably under 0.1%. That this is 10-100 times more deadly is well. . . tragic.
 
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William Haskins

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Okay, so my math was off.

The rest of the comment still stands. We have drugs out there now which list everything from headaches to straight-up death as side effects. Not that it all isn't horrible, but why is this standing out?

the article will help you with its words:

Every year around the world thousands of people take part in clinical trials but incidents like this are very rare, the BBC's Hugh Schofield reports from Paris.
 

Alessandra Kelley

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The Guardian story has more information: http://www.theguardian.com/science/...r-unprecedented-accident-in-french-drug-trial

It says the drug was tested on different groups in different dosages.

These six men appear to be the entire most recent group which got the highest and most regular dosages. They started showing stroke-like symptoms three days after they started the drug.

So it is closer to 100% than 6.67%.
 

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Well, if you're young enough to call me Grandpa, maybe you should look into it when they re-open the trials. Likely have the years to risk, and after this the pay will probably be pretty good. Might even help you out with your personality.
 

William Haskins

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let's see how sparkling your personality is when your mother dies in a drug trial.

mine was. well, not this type of test, but in an actual criminal trial in a courtroom.

she was attacked by a hyena. she fought hard, man. she fought real hard.
 

ShaunHorton

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I... I'm sorry. I didn't know.

Damn hyena's anyway. There should be laws against bringing them into courtrooms!

Unless the hyena is a witness. Even then they should at least be on a leash.
 

blacbird

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Okay, so my math was off.

The rest of the comment still stands. We have drugs out there now which list everything from headaches to straight-up death as side effects. Not that it all isn't horrible, but why is this standing out?

Because your math wasn't just "off", it was horrendously off. There's a statistical difference between one person in fifteen thousand suffering a bad side effect, and one person in FIFTEEN suffering a bad side effect.

caw
 

Cyia

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Okay, so my math was off.

The rest of the comment still stands. We have drugs out there now which list everything from headaches to straight-up death as side effects. Not that it all isn't horrible, but why is this standing out?

During a trial, ANY condition that arises must be listed as a potential side effect. If you get headaches, then that's a potential side effect, even if the headaches aren't directly traced to the drug. If you get an infection, then infections become a potential side effect, just in case the drug contributed to the ease at which you got the infection. What's important is the incidence of said side effects.

One person dies, then it's possibly a one off. Twelve people die, that's a cluster of significant size. One person ends up with brain-related issues, that's possibly a one off. Five people suffering the same damage, with at least one of those progressing to brain death, and that's a cluster of significant size and impact. It's all about the percentages and where/how the clusters occur in the sample size.