French drug trial leaves one brain dead and five critically ill -

French drug trial leaves one brain dead and five critically ill -

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.”

Read more -
http://www.theguardian.com/world/2016/jan/15/french-drug-trial-one-person-in-coma-and-five-critically-ill