Rennes (France) (AFP) - A man who was left brain-dead after
suffering serious side-effects during a drugs trial in France died on
Sunday, according to the hospital which had been treating him. Five other volunteers hospitalised a week ago when
the drugs trial went wrong were "in a stable condition", the hospital in
the western city of Rennes said in a statement.
The private
laboratory Biotrial was testing a new pain and mood disorder medication
for Portuguese pharmaceutical company Bial on humans for the first time,
in what is known as a Phase I trial, to test the drug's safety.
A
total of 108 volunteers took part in the trial, 90 of whom received the
drug at varying doses while the rest were given placebos. The six men who were hospitalised, aged 28 to 49, were the group which received the highest dose.
Pierre-Gilles
Edan, head of the neurology department at the Rennes hospital said
Friday that three of the men were suffering a "handicap that could be
irreversible" and another also had neurological problems. The sixth volunteer had no symptoms but was being monitored.
"The
84 other volunteers exposed to the drug" have been contacted, said the
hospital. Ten of them came in to be examined and did not have the
"anomalies" seen in the hospitalised patients.
The incident is the worst of its kind ever to have taken place
in France, which has launched three separate probes to determine whether
the tragedy was caused by an error in the trial's procedures or in the
substance tested. Bial is cooperating with the investigation and vows it followed "international best practice" in developing the drug.
"Our principal concern, at the moment, is taking care of participants in the trial," Bial said in a statement on Friday.
Biotral
said in a statement on Sunday that it is planning to work with the
international scientific community to develop "changes to the standards
governing such trials", without giving further details. The
company, which has been carrying out drug trials on behalf of
pharmaceutical companies since 1989, said the situation is "even more
upsetting given that there is as yet no explanation".
Previous testing, notably on animals, had not thrown up any unusual results.
- Damaged for life -
Such
serious mishaps are rare during the development of a drug, which begins
in the laboratory before being animal tested and then three phases of
human trials before it can be brought to market.
France's public
body ONIAM, which is responsible for compensating the victims of medical
accidents, said it had in its files only around 10 cases of accidents
during drugs trials over the past 15 years, and "with consequences
infinitely less serious" than the case in Rennes.
Although a rarity, there have been precedents in other countries.
A
comparable accident took place in 2006 in London when six people taking
German drug manufacturer TeGenero's TGN1412, which it was developing to
treat certain types of cancer and other immunological diseases, fell
seriously ill, with one suffering from multiple organ failure.
Two
of the volunteers were in a critical condition and one lost all his
fingers and toes. The victims said they had the impression that their
brains were on fire and that their eyes were coming out of their
sockets.
Although they all survived, experts said at the time that their immune systems would be damaged for life.
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