Nearly two months after he willingly became a human guinea pig in pharmaceutical tests carried out by the Biotrial company in Rennes, Stéphane Schubhan (42), a professional photographer, does not know if he can ever work again.
Schubhan sleeps badly, has nightmares, sees double at all times, walks with difficulty, and succumbs to dizziness and nausea if he stands more than 10 minutes at a time. Doctors say they hope his condition will improve in six months to a year, but they are not certain.
The death of a fellow volunteer on January 17th and the hospitalisation of five others, including Schubhan, shocked the French medical establishment and the pharmaceutical industry worldwide. Three separate inquiries are underway.
Test molecule
Investigators have faulted Biotrial for continuing to administer the test molecule, BIA 10-2474, to five others after the first volunteer was hospitalised with severe headaches. It was only after the first victim suffered a stroke that the tests were stopped.
Schubhan is the first survivor of the Biotrial tests to recount his story, in an interview with the regional newspaper Le Maine Libre.
When Schubhan reported suffering from headaches on January 11th, four days after the tests started, Biotrial’s doctors gave him paracetamol. The following day, his eyelids turned black. They added an ice pack.
When he tried to get up on January 13th, he could see nothing, felt dizzy and fell.
Schubhan was taken to Rennes hospital. “The scan showed blood stains and white streaks on my brain,” Schubhan described. The experimental drug caused lesions in the hippocampus, the central lobe of the brain.
The following day, doctors advised his companion to bring their children to see him, “just in case”.
Schubhan had volunteered for pharmaceutical tests before. Two years ago, he took an experimental drug for Alzheimer’s disease.
“I do it for money,” he said. “I signed up again because the first time, everything went fine. It was for the same length of time – two weeks – about the same amount of money (€1,900).”
Biotrial conducted the tests under contract to Bial, the leading pharmaceutical company in Portugal. BIA 10-2474 was developed to treat motor disorders caused by neurodegenerative diseases, moodiness and anxiety.
Before humans
Le Figaro
revealed on February 25th that two dogs and a monkey on whom the drug was tested prior to its testing on humans had died.
“They didn’t tell us the truth about the dogs,” Schubhan said. “If I’d known the dogs were dead, I wouldn’t have risked my life for €1,900. I wouldn’t have signed up. I’m not crazy.”
Biotrial has hired a PR firm that specialises in crisis communications and a former investigating magistrate who was spokesman for the ministry of justice. The firm justified not having revealed the animal deaths on the grounds that those tests were conducted by Bial in Portugal, not by Biotrial at its Rennes headquarters.
"We received a 15-page summary of the tests that was based on data that would have filled a lorry," François Peaucelle, the director general of Biotrial, told Le Figaro. "From that data, there was nothing worrying in view of the dosage we were administering to humans."
In other words, the animals that died received far greater doses than the humans. During the human tests, the dosage increased from 20mg to 50mg per day.
Minister of health Marisol Touraine has promised "full transparency" regarding the Biotrial victims. But the National Agency for the Security of Medication has come under fire for refusing to reveal what it knows on the grounds of "industrial secrecy".
