Hmmm six hospitalized, one of them brain dead, in a phase one trial, this is just a test of the drug’s safety, not efficacy, and comes after drug testing in animals has proven it to be safe and effective. So how did this drug, which is so far unnamed, get through?
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.
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.
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.
Biotrial, a drug-evaluation company based in Rennes, said in a statementthat the “serious adverse effects” had occurred during one of its trials, but it did not identify the maker of the pharmaceutical.
“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.”
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.
“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.
Ms. Touraine was traveling to Rennes and planned to speak at a news conference in the afternoon.
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.
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.