Clinical trial gone wrong: Bial suspends experiment after 1 brain dead, 5 hospitalised due to painkiller

Bial, a pharmaceutical company in Portugal, has suspended a human clinical trial in France of a painkiller it is developing. The suspension was the result of one volunteer becoming brain dead and five others hospitalised, three of whom could possibly suffer from brain damage.

All six male volunteers are between the ages 28 and 49 and were healthy when they started taking the inhibitor on Jan. 7 at a private Biotrial testing centre in Rennes, according to Reuters. The volunteer who was found brain-dead was brought to Rennes Hospital on Monday, while the five others were brought in on Wednesday or Thursday.

Besides the three who could have permanent brain damage, one patient reportedly has neurological problems and the other is in a less critical condition, reports Associated Press. Unfortunately for the six volunteers, there is no known treatment for the effects of the painkiller, says Gilles Edan, chief neuroscientist at Rennes Hospital.

Bial began testing the compound, a molecule which treats pain, in June. Since then, it has administered the inhibitor to 108 patients but none of them had any moderate or serious reaction, until last week, points out Bial.

In a statement, Biotrial says the clinical trials were done following international rules and its own procedures. The Rennes-based facility, which has over 25 years of experience in clinical trials, has offices in London and New Jersey.

The incident also highlights the risks that volunteers, who earn between $110 and $4,920 (AUD$160 and $7,168) in France, face. Adverse outcomes of clinical trials are uncommon in Australia where thousands participate in trials yearly, says Professor John Zalcberg, chairman of the Australia Clinical Trial Alliance.

Zalcberg concedes that there are potential risks for volunteers exposed to any experimental drugs, but most Aussie volunteers are aware of the risks. He highlights the importance of clinical trials in developing new drugs and the presence of a regulatory system in Australia to protect volunteers, reports The Herald Sun.

French Health Minister Marisol Touraine said the incident was unprecedented in France, and promised the French government would do everything to understand what had happened. The Paris prosecutor’s office is now probing the incident.