Medical trial gone wrong

[Arrowfoot]

Really unfortunate and sad. Death are rare.

http://uk.reuters.com/article/uk-france-health-test-idUKKCN0UT137

World | Fri Jan 15, 2016 2:18pm GMT
Related: WORLD
French 'cannabis' drug trial leaves one brain dead, five injured
PARIS | BY MATTHIAS BLAMON

An ambulance is seen outside the Emergency Entrance at the CHU de Rennes hospital, in Rennes, France, where six people are in a serious condition after taking part in a medical trial for an unnamed European laboratory to test a new drug, France's health ministry said January...
REUTERS/STEPHANE MAHE


One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in western France of an experimental medicine from an unnamed drug company, the French health ministry said on Friday.

The ministry did not say what the medicine was intended to be used for, but one person familiar with the situation said the drug was a cannabis-based painkiller.

The ministry said the six volunteers in Rennes, Brittany, had been in good health until taking the oral medication, which was developed by "a European laboratory".

Britain's GW Pharma (GWP.L), which markets an approved cannabis-derived treatment for spasticity caused by multiple sclerosis, said it was not involved in the trial.

"This test was carried out at a private facility specialised in carrying out clinical trials," the ministry said in a statement.

The brain dead individual was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.

All trials on the drug have now been suspended and all volunteers who have taken part in the trial are being called back.

A spokeswoman for the European Medicines Agency in London said it did not have full details of the case but that it was monitoring the situation.

Cases of early-stage clinical trials going badly wrong are rare but not unheard of. The last drug trial disaster in Europe occurred in 2006, when six healthy volunteers given an experimental drug in London ended up in intensive care.

One of them was described as looking like "the elephant man" after his head ballooned. Another lost his fingertips and toes.

In the initial so-called Phase I stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body and what is the right dose to give to patients.

"Undertaking Phase 1 studies is highly specialist work," said Daniel Hawcutt, a lecturer in clinical pharmacology at Britain’s University of Liverpool.

Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are finally approved for sale.

(Additional reporting by John Irish, Noelle Mennella and Ben Hirschler; Editing by Michel Rose and Gareth Jones)

 

[TreeHuggery]

Yeah I thought back to the 2006 case too.... people are needed to do these, but it can go horribly wrong, and because people, basically, sign a disclaimer at the beginning, there is little financial support to help ease the obvious financial losses when things go horribly wrong......

 

[TreeHuggery]

It seems like they have not learnt about dosing first in human from the TGN1412 trial. One of the most important things is to wait between dosing participants to make sure if there is a serious adverse event it only happens in one and not the whole cohort. Very sad

yep - don't want to "like" your post, cos that seems inappropriate, but completely agree with everything you say.....

 

[machew]

French media outlet iTELE claims that the drug, a pain reliever containing cannabis, is being developed by Biotrial. Also, Biotrial’s website contains a call for volunteers to participate in drug trials at Rennes and Newark, New Jersey. Biotrial has yet to issue a formal response, but the firm acknowledged that it will be participating in a press conference later today.

 

[User169]

It seems like they have not learnt about dosing first in human from the TGN1412 trial. One of the most important things is to wait between dosing participants to make sure if there is a serious adverse event it only happens in one and not the whole cohort. Very sad

Premature to draw that conclusion, I'd say.

 

[User169]

French media outlet iTELE claims that the drug, a pain reliever containing cannabis, is being developed by Biotrial. Also, Biotrial’s website contains a call for volunteers to participate in drug trials at Rennes and Newark, New Jersey. Biotrial has yet to issue a formal response, but the firm acknowledged that it will be participating in a press conference later today.

Biotrial is a CRO. It won't be their drug - they'll be the ones administering the trial.

 

[machew]

Biotrial is a CRO. It won't be their drug - they'll be the ones administering the trial.

Yup your right, sorry
http://www.independent.co.uk/news/w...ial-defends-drug-testing-safety-a6814641.html

 

[Arrowfoot]

French drug trial leaves one brain dead and three facing permanent damage
Government promises to investigate ‘unprecedented’ accident as six volunteers remain in hospital after trial for pharmaceutical company Bial

The six men, aged between 28 and 49, were described as fit and healthy before they began the trial testing medication designed to treat mood disorders. Photograph: Stephane Mahe/Reuters
Angelique Chrisafis in Paris
Friday 15 January 2016 19.13 GMTLast modified on Friday 15 January 2016 19.37 GMT

One man is brain dead and three others could face irreversible neurological damage after they volunteered to take part in a drugs trial in western France.
Six volunteers remain in hospital in Rennes, Brittany, after taking part in the Phase 1 trial for a new experimental medication designed to treat mood disorders such as anxiety, which was under development by the Portuguese pharmaceutical company Bial.
The French government promised to investigate the “tragic circumstances” of what it called an unprecedented and exceptionally serious accident which has sent shockwaves through the pharmaceutical industry.

French drug trial leaves one brain dead and five critically ill

Read more​

The six men, aged between 28 and 49, had been pronounced fit and healthy when they arrived at the Biotrial private clinic at the start of the drug trial on 4 January.
As paid volunteers , they spent over a week at the approved clinic where they tested the drug by regularly taking increased doses by mouth. Approximately 90 people had taken the drug while about 30 others received a placebo.
The six men who were hospitalised were the group who had taken the drug regularly and had taken the most.
Contrary to earlier reports, the health minister Marisol Touraine stressed that the drug did not contain cannabis or any element derived from cannabis. The minister said the drug was meant to act on the body’s endocannabinoid system. It had an impact on receptors which regulate pain, mood or appetite.
The men began taking the drug on 7 January after being checked for health and fitness. The first volunteer was admitted to the neurology department at the nearby hospital in Rennes three days later.
Pierre-Gilles Edan, head of the neurology department, said the man had come in with acute symptoms similar to a stroke and was now in a brain-dead state. The other volunteers were admitted to hospital shortly after. He said four men were suffering from neurological problems, three of whom might face permanent damage. A sixth volunteer was being monitored in hospital.
He said there was no known antidote to the drug because it had never been used on humans in that dosage. All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.
A judicial investigation has been opened by the French state prosecutor as well as two separate state-run inquiries. After visiting the men and their families in hospital, Touraine, promising to shed light on who was responsible, said: “Their distress is immense. Their lives have been brutally turned upside down ... The shock is even greater given the fact that the people taking part in clinical trials are healthy.”
In the initial Phase 1 stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body and what is the right dose to give to patients.
Cases of early-stage clinical trials going wrong are rare but not unheard of. There was a similar incident in Britain in 2006, when six previously healthy men were treated for organ failure only hours after being given an experimental drug targeting the immune system.
The six men who received the drug suffered a severe immune reaction which caused swelling and widespread organ failure. One patient was described as looking like the “elephant man” after his head swelled up; another has since required surgery to remove fingers and toes, and all the volunteers have been told they face a heightened risk of cancer and immunological disorders in later life. The catastrophe happened even though trials in animals suggested the drug was safe.
The incident prompted a review of procedures and resulted in the UK regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs only in one person at a time.
The French health ministry urged calm and said no drug currently on the market was implicated in the failed trial.

 

[Billy Wizz]

I am sure the,Pharmaceutical giants will shrug it off as usual.

 

[hopless500]

I am sure the,Pharmaceutical giants will shrug it off as usual.

Having worked for Boots Pharmaceuticals, I can assure you, they won't.

 

[raleighnut]

It was nothing to do with cannabis, it did however act on the same receptors in the brain

Contrary to earlier reports, the health minister Marisol Touraine stressed that the drug did not contain cannabis or any element derived from cannabis

 

[Billy Wizz]

Having worked for Boots Pharmaceuticals, I can assure you, they won't.

Good old Boots..

 

[stephec]

Is this not more suited to SCP?

 

[TreeHuggery]

just read that one of them has died........ it's awful

 

[Arrowfoot]

just read that one of them has died........ it's awful

Really sad. It seems the others who were admitted are not in a stable condition.