Making Unique Observations in a Very Cluttered World

Friday, 15 January 2016

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

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.”

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Ebola death in Sierra Leone hours after WHO declares outbreak over -

Ebola death in Sierra Leone hours after WHO declares outbreak over - 

Sierra Leone officials have confirmed a death from Ebola, hours after the World Health Organization declared the latest West Africa outbreak over.
The country was declared free of the virus on 7 November, and the region as a whole was cleared when Liberia was pronounced Ebola-free on Thursday.
Tests on a person who died in northern Sierra Leone proved positive, an Ebola test centre spokesman told the BBC.
The WHO has warned, however, that more flare-ups are expected.
How Ebola changed the world
Mapping Ebola
The Sierra Leone death occurred earlier this week.
Ebola test centre spokesman Sidi Yahya Tunis told the BBC that the patient had died in the Tonkolili district. He had travelled there from Kambia, close to the border with Guinea.

The tests were conducted by British health experts. The BBC's Umaru Fofana in the capital Freetown said health officials were now urgently seeking those who had come into contact with the victim.
Close to 4,000 people have died of Ebola in Sierra Leone, and 11,000 people across the region, since December 2013.
Liberia was the last country to see the end of active transmission of Ebola. But it had been declared clear twice before, only for the infection to re-emerge.
A country is considered free of human-to-human transmission once two 21-day incubation periods have passed since the last known case tested negative for a second time.

Read more -