Servier begins manslaughter trial over weight loss drug
French pharma Servier begins trial today, as the company stands accused of manslaughter and deceit over a diabetes weight loss drug linked to as many as 2,000 deaths.
The drug, Mediator (benfluorex), was pulled out of French pharmacies in 2009 after 33 years on the market. A year later, the French medicine safety agency announced the drug was suspected of causing multiple deaths, sparking outrage, a criminal investigation and a series of reforms to the country’s system of regulating the pharmaceutical industry.
Servier acknowledged the deaths and said it was working on compensating victims, already handing out €132 million ($146 million) in payments. But it denied the charges that it misled the public and lied about the drug’s side effects. The French drug regulator is also on trial, accused of leniency and a failure to act to prevent patient deaths. The agency has said it will cooperate with the trial.
All told, the trial will involve 21 defendants, including 14 people, among them a former company vice president, civil servants, a former senator and a professor of pediatrics retained by Servier. The case contrasts sharply with a US system where investigations of organizational wrongdoing rarely result in individual prosecutions. The trial is expected to last 7 months — one of the longest in Paris in decades — and involves 2,600 plaintiffs.
Mediator is an amphetamine-based appetite suppressant and though it was marketed as a way to address excess weight in diabetics, it was reportedly widely prescribed as a weight loss drug, including to many healthy women. Authorities estimated 5 million people took the drug before it was pulled.
Some of these women found themselves unable to climb stairs and exposed to a host of cardiovascular problems. In addition to the deaths, thousands are estimated to be suffering debilitating side effects from the drug.
The drug, however, remained on the market despite concerns and the removal of a similar drug from the US market in 1997. Mediator was pulled from several countries, including Italy and Spain, in the early 2000s, but didn’t leave the French market until 2009, two years after French lung specialist Irene Frachon reviewed patient records and found a link between the drug and serious heart and lung damage.
“The trial comes as huge relief,” Frachon told Reuters. “Finally, we are to see the end of an intolerable scandal.”
Two main studies were performed on the drugs’ negative impact, one finding it caused 500 deaths. Another: 2,000 deaths. Servier disputes these figures, saying there are only three documented deaths clearly attributable to Mediator and not other aggravating factors.
The French indictment alleges Servier “knowingly concealed the medication’s true characteristics,” according to Reuters, and hid unfavorable medical studies.
Servier is the country’s second-largest pharmaceutical company behind Sanofi. It makes a broad set of generics and researches new treatments on Alzheimer’s and oncology. Last year, it bought Shire’s oncology unit for $2.4 billion.