Paris (AFP)

"Upset" after weeks of hearing dedicated to the victims of the Mediator, the former number 2 of Servier laboratories returned to the bar on Tuesday to apologize and try to explain the "evaluation errors" of the firm which have led to one of the worst health scandals in France.

"It is with particular gravity that I appear before you today", starts Jean-Philippe Seta who worked for the laboratories. For the first time, the ex-leader, who faces five years in prison, is heard on injuries and manslaughter. He says he is "upset" by the testimony of successive victims since early December: "I want to apologize," he said.

The sexagenarian is the main defendant among natural persons in the trial of the Mediator, an appetite suppressant marketed between 1976 and 2009, held responsible for the death of hundreds of people. "It is clear that we have made mistakes," he said. He is "all the more aware" after four months of trial.

But the defendant, sure of himself, continues: he intends to "convince" the court that "the errors of evaluation and assessment were neither deliberate nor intentional". Clearly, for Mr. Seta, the laboratory was not aware of the dangerousness of the Mediator.

The first error dates back to 1998, he said. The Italian authorities had then launched an alert, due to the chemical relationship between the Mediator and two appetite suppressants marketed by Servier (Isomeride and Pondéral), and banned in 1997. But Servier then lacked "lucidity", according to the former leader.

Nothing before 1998 ?, questions the president Sylvie Daunis. "No", simply replied the defendant, despite several alerts on the safety of the Mediator in the 90s.

The president questions at length the accused on the SPC, the summary of the characteristics of the product, a document intended for the doctors who synthesizes in particular the contra-indications and the undesirable effects of a drug. Among other things, laboratories are criticized for not informing doctors of the risks represented by the Mediator.

- "Toxicity" -

"In February 2001, there were discussions on modifications to the SPC with the drug agency. (...) How do you explain that it takes two years to arrive at a very small modification?" Asked the magistrate. . Answer: "I don't know". "In 2005, we missed an opportunity" to change the RCP, concedes Jean-Philippe Seta.

In 2002, doctors were concerned about "the potential toxicity of the Mediator". "Isn't there a flashing light that needs to be activated at this time?" Asked civil party lawyer Martine Verdier. "They are not blinders; it is a desire not to see," accuses the lawyer.

The president cites one by one of the cases of sick patients having taken Mediator in the 2000s.

"There are not enough elements to make drastic withdrawal decisions (from the medicine, editor's note). (...) It seems absurd today, but not at the time," he said. . A pharmacovigilance survey had been launched. "The fact that the product is under investigation was reassuring for me," insists the former number 2 of Servier.

Then, in this complex case, comes this simple, clear question from the prosecutor: "What was necessary for you to make a strong decision on this medication, what were you waiting for?". Silence. "This is a difficult question when we look at things a posteriori," replied the defendant finally.

The Mediator was withdrawn from the market in 2009, after Brest's pulmonologist Irène Frachon exposed the scandal.

The prosecutor is not finished. "1999 was a pivotal year" in terms of alerts, she said. A total of 95 cases of injuries and manslaughter are charged with Jean-Philippe Seta. "If the Mediator had been suspended in 1999, 64 of these people would never have taken this medication, and therefore would never have suffered from it".

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