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On September 23, a trial began in Paris to resolve one of the most significant drug ordeals in French history. According to the 677-page indictment at the heart of the trial, the French pharmaceutical company Laboratoires Servier “knowingly concealed” the lethal effects of Mediator, a drug it sold for thirty years. The company and its executive officers face charges of fraud and manslaughter for manufacturing and marketing a drug that may have claimed as many as 2,000 lives. The trial will also consider whether the French government’s National Agency for Drug Safety is guilty of negligence for failing to respond effectively to a public health crisis.
The seven-month trial will be one of the largest legal proceedings that has ever taken place in France. It will involve a total of 23 defendants, including the country’s second-largest pharmaceutical corporation, as well as 2,600 plaintiffs, 376 lawyers, over 100 witnesses, and two large courtrooms to accommodate the 500 people who are expected to attend the trial everyday. The enormity of the trial reflects the extent of the pain and distress that Mediator has inflicted on the people of France. “The trial comes as huge relief,” said Dr. Irene Frachon, a pulmonary specialist who first raised concerns about the dangers of Mediator. “Finally, we are to see the end of an intolerable scandal.”
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In 1976, Laboratoires Servier began selling Mediator, a weight-loss pill for people with type-2 diabetes. Benfluorex, the active ingredient in Mediator, supposedly alleviates insulin resistance. This condition afflicts some type-2 diabetics and may cause weight gain.
After Laboratoires Servier introduced Mediator, doctors in France started to prescribe it to non-diabetics who wanted to lose weight by taking it as an appetite suppressant. About five million people in France used Mediator over the course of three decades, and it became one of the most popular prescription medications in the country. Tragically, studies now indicate that Mediator likely resulted in 500 to 2,000 deaths by heart and respiratory failure. Many people who lost their lives as a result of taking Mediator suffered fatal pulmonary hypertension and heart valve complications. Additionally, thousands of people who used the medication and survived now live with permanent health problems.
In 1997, an array of lawsuits forced another company, American Home Products, to stop selling a similar drug in the United States. Several years later, France’s neighbors Spain and Italy banned Mediator, and British and American drug regulators refused to approve it as safe. All this notwithstanding, Laboratoires Servier continued to sell Mediator in France until the government finally forced the company to withdraw it from the market in 2009.
Many victims of Mediator claim that Laboratoires Servier knew that Mediator was dangerous, yet chose to sell it anyway. The company allegedly earned at least one billion euros from Mediator sales. In 2007, Dr. Irene Frachon discovered that people who used Mediator exhibited a pattern of heart problems. Her findings shocked France and served as the basis of a book and a movie, “150 Milligrams.” Dr. Frachon calls Mediator “poison” and accuses Laboratoires Servier of “endless denial of responsibility.”
The company acknowledges that Mediator has proven to be harmful and has already paid victims a total of 132 billion euros in damages. However, the company denies lying to patients and doctors about the drug’s safety. Laboratoires Servier executives insist that they never knew that Mediator posed serious health risks. After all, they sold Mediator without objection from the French government.
For this reason, the plaintiffs in the trial are also seeking to hold the National Agency for Drug Safety accountable for failing to protect patients from Mediator, even though other countries recognized it as dangerous. Plaintiffs allege that the Agency was influenced by policymakers who had corrupt relationships with Laboratoires Servier, such as one former senator who purportedly modified a document about the risks of Mediator after meeting one of the company’s lobbyists. The former senator is one of the 23 defendants.
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As a result of this case, the French government has enacted stricter ethics rules for the Agency. Furthermore, doctors in France will now be required to publicly declare any gifts they receive from a pharmaceutical company, since some doctors are also facing charges for promoting Mediator to diabetics and non-diabetics alike after accepting bribes from Laboratoires Servier.
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