PARIS (Reuters) – A landmark French trial will from next week seek to settle one of the country’s biggest pharmaceutical scandals, probing whether the company behind a weight-loss drug believed to have triggered killer side-effects covered up the risks.
Privately-owned Servier, regulator Agence nationale de securite du medicament (ANSM) and 21 defendants will face more than 2,600 plaintiffs who believe the drugmaker deliberately misled patients for decades, helped by lenient authorities.
The charges range from deceit to manslaughter which, under French law, could result in fines and jail sentences.
The case caused an outcry in France, where authorities have said as many as five million patients were exposed to the drug, known as Mediator, before its withdrawal in 2010, causing between 500 and 2,000 related deaths.
The seven-month trial will also question why the pill, introduced in 1976 in France and suspected of causing heart and pulmonary failure, was on the market for so long.
“The trial comes as huge relief. Finally, we are to see the end of an intolerable scandal,” said Irene Frachon, a French pneumologist, who worked on raising the alarm publicly.
Servier’s amphetamine-derived drug was developed to treat excess weight in type-2 diabetes patients, but was also widely prescribed as an appetite suppressant.
Several countries such as Spain and Italy banned the drug in the early 2000s.
Mediator, whose active substance is called benfluorex, was close in structure to fenfluramine, another appetite suppressant sold by American Home Products, later known as Wyeth and now part of Pfizer.
That drug, sold along with phentermine in a combination known as fen-phen, was also linked to pulmonary hypertension and heart valve dysfunction, leading to its withdrawal in 1997 along with thousands of legal claims of health problems and deaths.
In the 677-page French indictment, seen by Reuters, magistrates wrote that Servier from the 1970s “knowingly concealed the medication’s true characteristics” and hid medical studies unfavorable to the product, establishing a long term fraud.
“The fact that a trial is ultimately taking place is, in itself, a victory for the victims,” Charles Joseph-Oudin, a lawyer for 250 plaintiffs, said.
Servier has said it did not lie about the effects of the treatment and hopes to demonstrate it did not act against patients’ interests.
The company has paid out almost 132 million euros ($146 million) to patients and says it will continue to compensate victims.
“There is a series of circumstances highlighting how all this took place,” said Francois de Castro, a lawyer for the firm.
The trial will also examine the role of regulators, after an official French investigation in 2011 found the industry watchdog had been too slow to act and was too close to pharmaceutical companies.
The ANSM said it would cooperate with the trial and was now abiding by stricter ethics rules.
Reporting by Matthias Blamont, Simon Carraud; Editing by Sarah White and Mark Potter