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Pharma Company’s Experimental Drug Trial Turns Fatal in France

by Reshma Anand on  January 18, 2016 at 6:25 PM Clinical Trials News   - G J E 4
During a drug trial in France, a man who was left brain-dead after suffering serious side-effects has died, according to the hospital which had been treating him.
Pharma Company’s Experimental Drug Trial Turns Fatal in France
Pharma Company’s Experimental Drug Trial Turns Fatal in France
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Five other volunteers hospitalized 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.

‘A private laboratory was testing a new drug for pain and mood disorder for the first time on 84 men who were left with several neurological problems including a death of one volunteer in France.’
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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 hospitalized, 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 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 hospitalized 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.

Biotral said in a statement 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.

Source: AFP
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