Botched french drug trial leaves 1 brain dead

1. Botched French drug trial
leaves 1 brain dead
5 Others Hospitalised After Taking Experimental
Painkiller; Total Of 90 Volunteers Given Medicine
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2. Contd…
One person has been left brain-dead and five others are in serious condition after
taking part in a clinical trial in France of an ex perimental painkiller made by
Portuguese drug company Bial, the French health ministry said on Friday. The
medicine involved works by targeting the body's pain-controlling endocanna binoid
system, which is also responsible for the human response to cannabis.
The ministry said the six volunteers in Rennes, in western France, had been in good
health until taking the ora medication at a private facility that specialises in carry
ing out clinical trials.
The brain-dead volunteer was admitted to hospital in Rennes on Monday . Other
patients went in on Wednesday and Thursday .
The volunteers are al men aged 28 to 49, French health minister Marisol Touraine
told a news conference. They started taking the drug on January 7. One person
started feeling ill on Sunday and the other five afterwards.
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3. Contd…
In total, 90 people have taken part in the trial, taking some dosage of the drug, she said,
adding that others took a placebo. All trials on the drug have 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 was
monitoring the situation.
Cases of early-stage clinical trials going badly wrong are rare but not unheard of.
In 2006, six healthy volunteers given an experimental drug in London ended up in intensive
care. One was described as looking like “the elephant man“ after his head ballooned.
Another lost his fingertips and toes. In the initial 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 I 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.
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4. Contd…
Europe has strict regulations governing the conduct of clinical trials, with Phase I
tests subject to particular scrutiny . But Ben Whalley ,a professor of
neuropharmacology at the University of Reading, said these could only minimise
risks, not abolish them. “There is an inherent risk in exposing people to any new
compound,“ he said.
The 2006 London trial led to the collapse of Germany's TeGenero, the companuy
developing a medicine known as TGN1412. The drug has since gone back into tests
for rheumatoid arthritis and is showing promise when administered at a fraction of
the original dose. No known antidote for medicine being tested: Scientist The chief
neuroscientist at a hospital in Rennes, where a botched drug trial has left six people
hospitalised, said there's no known antidote to the experimental drug they were
testing. Professor Gilles Edan spoke to journalists on Friday. The French
prosecutor's office has opened a probe into what the health ministry is calling a
“serious accident during a clinical test“ at the Biotrial laboratory in Rennes.
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