ElizaBeth R

Oasis medspa

Saturday, 16 January 2016

French drug trial leaves one brain dead and five critically ill

One person is brain dead and five others are seriously ill after taking part in a drug trial for Portuguese pharmaceutical firm Bial at a clinic in north-west France.




The French health ministry said the six male patients aged 28 to 49 had been in good health until taking the oral medication. They started taking the drug on 7 January. One person started feeling ill on Sunday and the other five afterwards. The brain dead volunteer was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.


Pierre-Gilles Edan, head of the hospital’s neurology department, said one man was brain dead, three others were suffering a “handicap that could be irreversible” and another had neurological problems. The sixth volunteer had no symptoms but was being monitored.


 The French health minister, Marisol Touraine, said 90 people in total had taken part in the trial and received some dosage of the drug; others had taken a placebo. All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.

The ministry said the test was carried out by the Biotrial clinic for Bial, which “specialised in carrying out clinical trials”.
The trial was intended to test for side-effects of the new drug but all trials at the clinic have been suspended and the French state prosecutor has opened an inquiry.

Touraine said the drug was a so-called FAAH inhibitor meant to act on the body’s endocannabinoid system, which deals with pain. 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.

Touraine said the study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”.

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. 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.
Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said.

Bial said it was committed to ensuring the wellbeing of test participants and was working with authorities to discover the cause of the injuries, adding that the clinical trial had been approved by French regulators.

Every year, thousands of volunteers, often students looking to make extra money, take part in such trials. Mishaps are relatively rare, but in 2006 six men were treated for organ failure in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia.
The men now apparently have a higher risk of cancer and autoimmune diseases tied to their exposure to the experimental drug.

Dr Ben Whalley, a neuropharmacology professor at Britain’s University of Reading, said standardised regulations for clinical trials were “largely the same” throughout Europe. “However, like any safeguard, these minimise risk rather than abolish it,” Whalley said. “There is an inherent risk in exposing people to any new compound.”

culled from Theguardian.com

Agence France-Presse contributed to this story




57 comments:

Lilian Fc Barcelona said...

Hmmmmmmm,this is serious.

Eko Wengele said...

See wahala. Thank God they did not come to Africa for the test

Lucinda Maya said...

The French are such callous people!!! Drug trials should be done on animals not humans! French Fuckers! !!

Lucinda

Princess Scheherazade said...

See as they just use their hand collect problem...
Baba God, please continually and ceaselessly direct my steps please.

Anonymous said...

Dat is one badt drug, smh. Do people volunteer for money or what?

Nmasinachi said...

Yup, they get money for it. In the occurrence of death, their families are paid. It is a common practice abroad. Once tested on humans, you can see the side effects by the pack of the drug.

raphael michael said...

What was the initial result from rodent trials because such trial drugs must first be given to rodents and the reactions noted before human trials are done.

Anonymous said...

Ignorance. So they do drug trial on chimps and give you the buyer subsequently? Drugs must b tried on humans- healthy volunteers, after successful animal trials

Chidinma Grace said...

This is serious!

Nki said...

This is so unfortunate on every level! These drugs trials are usually commenced on animals and when that stage goes well it's then moved up to humans.

It's so unfortunate as it couldn't have been anticipated. That's one of the unavoidable risks of trials. You just have to be ready for any thing as it's virtually uncharted territory.

Monkey Face said...

Shut up biko

Monkey Face said...

Bia Nwokem, did you read the post atall?

Ade Esther said...

Drug trials on human being... issokay

African Royalty 4Sure said...

I'm sure d volunteers had one terminal health issue or d other & were willing to be lab rats just to get a cure.
I wouldn't subject myself to this when I'm hale & hearty.

Anonymous said...

Shut up ignorant Lucinda... Drug trials happen everywhere even in the Uk... You know the risk and they are not forced... And

Miss_Blandish said...

Bye bye "canabiswateva"... Na money go finish this world,I swear!

Anonymous said...

Yes some people volunteer for money... But people are not forced, they explain to u... They all know it's a new drug and not tested before so they can't be sued

Anonymous said...

Shut your ignorant Brain. How do they do drug trial for HIV that doesn't infect animals except human beings?
In the real sense, every drug is still under trial until it has been taken for decades, even at that they pull drugs out of market everyday because of some effects it has been noted to cause in humans that wasn't noticed in animals.
Even immunization that is widely used still kill some children and leave some with lifelong ailment.

Cindy said...

It's been tried on animals na, last year around July if I read right

Cindy said...

Chai! Aturu e jiri tuo aka (Sacrificial lamb) . A pity

Anonymous said...

Yes they volunteer for money. But I guess they must have agreed to the terms and conditions.

One trillion said...

End time drug trial

Iphie dearie said...

This is why bans are placed on certain drugs in some countries.

I feel so sad for terminally ill people,most of them are left with no choice than to try some of these drugs or procedures and end up with quacks sometimes.

These one's carry their healthy bodies go enter gbege!

Anonymous said...

Did you read the write up at all? Am sure you didn't cos if you did, you probably would have seen that the test are in different phases and these people volunteered for the drug trial on them. @Lucinda

Anonymous said...

Your comment shows how pathetically ignorant you are. Read and learn to avoid making uninformed comments.

Odus said...

See gobe

natt nathaniel said...

This is serious.
Well this is end time pharmaceutical shock.

Blackberry said...

Dey no see guinea pig use?

Dolapo said...

What do you mean? They test drugs like these all the time. Paracetamol that you took yesterday was once in the phase of clinical trial, as was the postinor you used last week. So you want then to test in Europe and bring the finished products back to african soil? That's why there was no cure for ebola, no cure for sickle cell disease etc. It's because of Africans like you! Sleep on that. .

Tayan Taylor said...

Why on humans

Genny le boo said...

I know someone that does this. He is a nigerian and does this. They are paid huge but the side effect is deadly like this. So sad what money can do

Gbogbo Bigz Girlz. (GBG) said...

All for the love of money.

Faith Martins said...

End time testing.....currently face timing with my boo

MAMACITA said...

Why didn't they use animals? Dis is murder/suicide ooo

Carina Jacob said...

God have mercy on us ooo


www.ckjacob.com

Wrench said...

This is some severe Side effect

Onis said...

Na wa oh see trouble

adeola adedayo said...

Enter your comment...May God help us
ROBOCOP

Stella Asemota said...

Too bad!

Queen Jay said...

This is one thg I won't do, be a lab rat, God should see them thru o,

Anonymous said...

Monkey face, that's why you are a monkey face.African Royalty and anons thanks for answering.

Shyla said...

Couldn't they use lab rats and guinea pigs? How can they reverse this brain dead one now? This is bad mehn.

Mr. Blaq said...

lols...lab rats.... serves them right......







.....Arsenal Biggest Fan.....

Yemi7up said...

I pray they get an antidote for it but is like I read no remedy in this case
. That means they still have a lot to do to get cure for the ailment they are working on.

Anonymous said...

Where do they pay them huge to be a part of clinical trials? Don't say what you don't know

Anonymous said...

You can't volunteer if you don't have the disease the drug is in trials for. How will they know it is effective or not?

james sax said...

No risk, no reward.

Anonymous said...

Celine Dion brother don die.

Anonymous said...

Lol.... Your comments just shows how ignorant you are....must u comment?

Genny le boo said...

At anonymous first of all you should have a name to talk. Second, am sure you won't be so stupid to risk your life to be a lab rat without gud compensation and third obviously you are confusing Nig clinical trial with that of Canada. So before you reply any further do your investigations!

PL THE GREAT said...

What? Which kain rough play be dis?? Brain dead, irreversible neurological damage just like that!
Mbanu.


My heart goes out to them.

Anonymous said...

In Canada,they pay you for Clinical trials @Anon21.16

Anonymous said...

Iphie u daft sha
Forming intelligence

Orielm Express said...

I hope they gave informed consent before the trial and given compensation for the mishap to them and not even to their family. This is why animal testing is still popular.

Anonymous said...

How much do they pay them oh that is huge madam Canadian? You are the stupid one that will assume someone that is not being treated for a disease with the so called drug in trial will just be on the clinical trial just to make money. So because you are in Canada now every other person has to be in a village in Nigeria right? You be oponu

Anonymous said...

And for your information madam Genny le boo the Canadian they also pay people in US for clinical trials and there are guidelines and safety procedures for all clinical trials. How can they just give medication to someone that is not sick with what the medication is supposed to treat ? You are the dumdass here and always think before you type and call other people stupid. You name on Stella's blog is worth taking to Bank of America abi? Ode radarada

Anonymous said...

Lol