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WORLD NEWSSaturday 16 January 2016

1 man brain dead, 5 others hospitalized in French drug trial

THOMAS ADAMSON                   French Health Minister Marisol Touraine, left, and Professor Gilles Edan, the chief neuroscientist at                            a drug evaluation com-
Associated Press                 Rennes Hospital, address the media during a press conference held in Rennes, western France,                                     pany based in Rennes, on
PARIS (AP) — One man             Friday, Jan. 15, 2016. Six previously healthy medical volunteers have been hospitalized —                                        behalf of the Portuguese
was brain dead and three         including one man who is now brain dead — after taking part in a botched drug test at the Biotrial                               pharmaceutical company
others faced possible per-       lab in western France, the French Health Ministry said Friday.                                                                   Bial.
manent brain damage                                                                                                                                               Touraine said that in addi-
after volunteering to take                                                                                                              (AP Photo/David Vincent)  tion to treating pain, the
part in a drug trial for a                                                                                                                                        drug was intended to ease
painkiller based on a natu-      unteers were being con-         like this.”                    damage. A fifth man is suf-                                       mood and anxiety troubles
ral brain compound similar       tacted.                         The drug trial for the six     fering from neurological                                          as well as motor problems
to the active ingredient in      Calling the case “unprece-      hospitalized men began         problems and a sixth man                                          linked to neurodegenera-
marijuana, French authori-       dented,” Touraine said she      on Jan. 7 and was halted       is being kept in the hospital                                     tive illnesses by acting on
ties said Friday.                was “deeply moved” by           Monday, a day after the        but is in less critical condi-                                    the endocannabinoid sys-
The Paris prosecutor’s of-       the suffering of the victims,   first volunteer fell ill.      tion, he said.                                                    tem.
fice opened an investi-          who she met with earlier Fri-   The chief neuroscientist at    Edan said there’s no known                                        In this system, natural brain
gation into what French          day, along with their fami-     the hospital in Rennes, Dr.    way to reverse the effects                                        compounds act on specif-
Health Minister Marisol          lies. “We’ll do everything      Gilles Edan, said in addition  of the experimental drug,                                         ic receptors to exert their
Touraine called “an acci-        to understand what hap-         to the brain-dead man,         which was given orally to                                         effects. The experimental
dent of exceptional grav-        pened,” she said. “I don’t      three other men could          healthy volunteers as part                                        drug is based on a natu-
ity” at a clinical trial lab in  know of any other event         have “irreversible” brain      of a Phase 1 trial by Biotrial,                                   ral brain compound similar
the western French city of                                                                                                                                        to the active ingredient in
Rennes.                                                                                                                                                           marijuana.
The trial involved 90 healthy                                                                                                                                     Touraine said the drug was
volunteers who were given                                                                                                                                         not based on marijuana it-
the experimental drug in                                                                                                                                          self, as some media reports
varying doses at different                                                                                                                                        had claimed.
times, she told reporters                                                                                                                                         “This drug is not cannabis.
at a news conference in                                                                                                                                           It is not derived from can-
Rennes.                                                                                                                                                           nabis. It works on the natu-
Six male volunteers be-                                                                                                                                           ral system that helps fight
tween 28 and 49 years old                                                                                                                                         pain,” she said, adding
have since been hospital-                                                                                                                                         that no drug currently on
ized, including one man                                                                                                                                           the market was implicated
now classified as brain                                                                                                                                           in the failed trial.
dead, Touraine said, add-                                                                                                                                         Bial, the Portuguese drug
ing that the other 83 vol-                                                                                                                                        producer, said Friday that
                                                                                                                                                                  108 healthy people had
EU, British officials upbeat about reform deal                                                                                                                    already taken part in trials
                                                                                                                                                                  involving the drug and had
RAF CASERT                       Cameron has promised to         the EU needs to fundamen-      bers, said the welfare issue                                      no moderate or serious re-
JILL LAWLESS                                                     tally change the way it is     would be “particularly dif-                                       actions. Bial added that
Associated Press                 hold the vote by the end of     run, reducing bureaucracy      ficult.”                                                          initial testing for the drug
BRUSSELS (AP) — Top offi-                                        and handing more power         Still, there was growing op-                                      started in June following
cials in Britain and the Eu-     2017, and says he will argue    to national legislatures.      timism on both sides of the                                       toxicology tests.
ropean Union say they are                                        Other  EU  leaders are sym-    Channel a deal could be                                           For the French volunteers, it
optimistic about striking a      to stay in the EU as long as    pathetic to that view.         brokered.                                                         was meant to be a way to
deal next month on reforms                                       Cameron’s most conten-         Osborne said the Treasury                                         earn extra money and help
aimed at discouraging Brit-      he gets a new deal for Brit-    tious goal is to bar migrants  was not making plans to                                           develop a drug to treat
ain from leaving the 28-na-                                      from other  EU  countries      navigate Britain’s exit from                                      people with pain and anxi-
tion bloc.                       ain, including more power       from receiving some ben-       the EU.                                                           ety. Adults volunteering for
EU  Commission President                                         efits until they have been in  He also dismissed sug-                                            Biotrial tests can earn be-
Jean-Claude Juncker said         to curb immigration and         Britain for up to four years.  gestions — made by Lon-                                           tween 100 euros and 4,500
Friday that he is “quite sure”                                   Many other EU leaders see      don Mayor Boris Johnson,                                          euros ($110 to $4,920).
a deal will be brokered at       looser ties with the Brussels-  that as violating the fun-     among others — that a                                             It’s rare for volunteers to fall
a Feb. 18-19 summit in Brus-                                     damental principle of free     referendum vote to leave                                          seriously ill during Phase 1
sels. That would allow Prime     based EU.                       movement among the             could trigger negotiations                                        trials, which study safe us-
Minister David Cameron                                           bloc’s member states.          on re-entry under different                                       age, side effects and other
to call a referendum on          “I’m quite sure that we will    Juncker, who has acted as      terms.                                                            measures on healthy vol-
Britain’s  EU  membership as                                     a facilitator between Brit-    “There’s no second vote,”                                         unteers, rather than drug
soon as the summer.              have a deal, not a com-         ain and the other EU mem-      he told the BBC.q                                                 effectiveness.q

                                 promise, a solution, not a

                                 weak compromise, a per-

                                 manent solution in Febru-

                                 ary,” Juncker said in Brus-

                                 sels.

                                 British Treasury chief George

                                 Osborne said the “essential

                                 pieces” of a deal were fall-

                                 ing into place.

                                 Cameron          argues
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