On September 23, the case involving Mediator began in Paris. Starting in the late 1970s, this anti-diabetic drug was also sold as an appetite suppressant in France. Dr. Grégoire Le Gal, a professor at the University of Ottawa's Faculty of Medicine, conducted a study proving that Mediator was responsible for serious heart complications, causing thousands of hospitalizations and hundreds of deaths.
Here is what he told The Gazette.
By Linda Scales
The Faculty of Medicine’s Grégoire Le Gal wasn’t looking to be involved in one of France’s most significant pharmaceutical scandals. But when he took a call in 2009 from pulmonologist Dr. Irène Frachon, also from Brest, France, he knew he had to do the right thing.
On that call he learned that Mediator (also known as Benfluorex), an anti-diabetic drug sold to French citizens as an appetite suppressant, was the cause of severe valvular heart disease—a condition that often needs to be treated with open heart surgery.
He says that Dr. Frachon believed this despite receiving pushback from Mediator’s manufacturer, Servier Laboratories, and health authorities telling her that there was nothing to worry about.
She called on Le Gal because she needed help proving her hypothesis; it was going to be difficult convincing the health authorities that such a severe side effect could be discovered after the drug had been on the market for more than 30 years.
“I mostly designed and conducted a study that demonstrated the association between the use of the drug and the disease,” says Le Gal. “I liked that challenge.”
His study helped link Mediator to approximately 500 deaths and another 3,500 hospitalizations.
On Monday, September 23, 2019 – nearly ten years after the drug was removed from store shelves – the case will be heard in criminal court.
This David and Goliath story was told in the acclaimed film, La Fille de Brest. Based upon Mediator 150 mg : Combien de morts? (Mediator 150 mg: How many deaths?), the 2010 book by Dr. Frachon in which she tells of her battle to have Mediator removed from the market.
The movie was first screened at the 2016 Toronto International Film Festival and has since been nominated for several awards including France’s Césars. In the movie, Le Gal was loosely portrayed by the character Antoine Le Bihan.
“He was sort of a mix of my actual role in the story with that of many others who were less supportive,” says Le Gal.
Born and educated in France, Le Gal joined the University in 2012 as a professor and a clinician scientist conducting research on venous thrombosis in the Division of Hematology. He also works at the Montfort Hospital.
Le Gal says that as a doctor the scandal reminded him that both doctors and patients need to be vigilant.
“It’s important to be wary of any unusual symptoms in patients taking medications, and to question the possibility of these being side effects – even if there is no obvious relationship,” he says. “These things don’t happen only in movies!