Botched drug trial leaves one patient 'brain-dead,' 5 hospitalized

A Phase I drug trial disaster has left 6 patients in serious condition with one effectively "brain-dead," according to the French government, which has opened an investigation.

The study, based in Rennes, recruited healthy volunteers to test the safety and tolerability of an undisclosed oral drug, the government said. A "serious accident" ensued, forcing the CRO running the study to halt dosing and recall all enrolled patients, according to French regulators.

Biotrial, the Rennes-headquartered CRO running the trial, said "serious adverse events related to the test drug" led to the hospitalizations, adding that it is cooperating with French authorities.

"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.

Both Agence France Presse and BBC reported that the drug being studied was a cannabinoid painkiller from Portuguese developer Bial, but the BBC said French officials denied at least that the treatment was cannabis-derived. Bial didn't respond to a request for comment.

Marisol Touraine, France's minister of social affairs and health, has promised to investigate what went wrong in the study, traveling to Rennes on Friday with plans for a news conference later in the day.

Traditionally, Phase I studies are the first attempt at establishing the safety of a drug in humans, though developers have been steadily pushing the envelope on trial designs for the past decade. Regulators only allow the studies after preclinical animal studies are complete to check for potential toxicities.

That system has kept early-stage trial disasters to a minimum, though there have been several instances in recent memory when studies have jumped the tracks, harming patients. The German biotech TeGenero was forced into bankruptcy after a mishap in 2006. 

- read the announcement (in French)
- here's Biotrial's statement
- here's the AFP report
- and the BBC's take

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