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6 Hospitalized, One of Them Brain-Dead, After Drug Trial in France 6 Hospitalized, One of Them Brain-Dead, After Drug Trial in France
(about 1 hour later)
LONDON — Six patients were hospitalized — one of them brain-dead — after a drug trial in northwestern France, the country’s health minister said on Friday. LONDON — Six men were hospitalized — one of them brain-dead — after a drug trial in northwestern France, the country’s health minister said on Friday.
Marisol Touraine, the minister for social affairs, health and women’s rights, said in a statement that her office was informed on Thursday evening about a “serious accident” that resulted in the hospitalization of six patients at the Centre Hospitalier Universitaire de Rennes, in eastern Brittany. Marisol Touraine, the minister for social affairs, health and women’s rights, said in a statement that her office was informed on Thursday evening about a “serious accident” that resulted in the hospitalization of the six at the Centre Hospitalier Universitaire de Rennes, in eastern Brittany.
The drug was being tested on healthy volunteers in a licensed private institution specializing in clinical trials, Ms. Touraine said in the statement. It had been administered orally as part of a Phase 1 clinical trial, according to the statement, which did not provide any further details about the drug or its manufacturer. “I have no knowledge of a comparable event,” Ms. Touraine said at an afternoon news conference in Rennes, calling the episode “unprecedented.”
Biotrial, a drug-evaluation company based in Rennes, said in a statement that the “serious adverse effects” had occurred during one of its trials, but it did not identify the maker of the pharmaceutical. The patients, all men, were 28 to 49 years old, she said. One was brain-dead, and the other five were receiving treatment from the hospital’s neurology department. Their conditions ranged in seriousness.
“The trial has been conducted in full compliance with the international regulations, and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital,” the company said in a statement. “We are in close and regular contact with the health authorities and ministry in France. The priority at Biotrial remains the safety of our subjects.” “I was deeply moved by their suffering,” Ms. Touraine said after visiting the patients and their families.
The company informed the French Agency for the Safety of Health Products, the country’s drug regulator, that the trial was halted, according to the Health Ministry. The agency will inspect the drug-testing site, and Ms. Touraine also directed the General Inspectorate of Social Affairs to conduct an inquiry. The health branch of the Paris prosecutor’s office has opened an investigation as well. The drug was administered orally on healthy volunteers as part of a Phase 1 clinical trial by Biotrial, a drug-evaluation company based in Rennes.
“Marisol Touraine wishes to share with the families of the patients her solidarity and her deep determination to shed light on this tragic accident and establish who was responsible,” the statement said. In a statement, the company acknowledged “serious adverse effects” in a trial, adding: “The trial has been conducted in full compliance with the international regulations, and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital. We are in close and regular contact with the health authorities and ministry in France.”
Ms. Touraine was traveling to Rennes and planned to speak at a news conference in the afternoon. Biotrial submitted its application to conduct the trial, on behalf of a Portuguese drug manufacturer, Bial, on April 30, Ms. Touraine said. The French Agency for the Safety of Health Products, the country’s drug regulator, authorized the trial on June 26, and it began on July 9.
Ms. Touraine said the drug had previously been tested on animals, including chimpanzees, and had been administered to 90 people under the trial. The six men received the drug several times, starting on Jan. 7. The first symptoms appeared in one man on Sunday; he was quickly hospitalized, and the other men followed. The trial was halted the next day.
Contrary to several reports in the French news media, the drug was not a cannabis-based painkiller, Ms. Touraine said.
The agency will inspect the drug-testing site, and Ms. Touraine also directed the General Inspectorate of Social Affairs to conduct an inquiry. The health branch of the Paris prosecutor’s office has opened an investigation as well.
Deaths or serious adverse reactions during Phase 1 clinical trials — which focus primarily on a drug’s safety and side effects, rather than on its effectiveness — are rare.Deaths or serious adverse reactions during Phase 1 clinical trials — which focus primarily on a drug’s safety and side effects, rather than on its effectiveness — are rare.
In March 2006, six previously healthy young men fell ill and spent weeks in intensive care, with severe damage to their immune systems, at Northwick Park Hospital in London after being injected with an immune-system stimulant, known as TGN1412, during a Phase 1 trial.In March 2006, six previously healthy young men fell ill and spent weeks in intensive care, with severe damage to their immune systems, at Northwick Park Hospital in London after being injected with an immune-system stimulant, known as TGN1412, during a Phase 1 trial.
Despite its potency, the drug, which was held up as a potential treatment for multiple sclerosis, leukemia and rheumatoid arthritis, was tested under much the same standards as those governing ordinary pharmaceuticals. British regulators approved the trial in just 17 days, and the testing company, based in Massachusetts, did not have an adequate response plan in the event of a disastrous adverse reaction, British investigators concluded.Despite its potency, the drug, which was held up as a potential treatment for multiple sclerosis, leukemia and rheumatoid arthritis, was tested under much the same standards as those governing ordinary pharmaceuticals. British regulators approved the trial in just 17 days, and the testing company, based in Massachusetts, did not have an adequate response plan in the event of a disastrous adverse reaction, British investigators concluded.