150 Milligrams

Mediator was developed by the pharmaceutical company Servier as a medication for diabetes and weight loss. It was marketed as an appetite suppressant for overweight diabetic patients. However, the drug's active ingredient was later found to cause severe heart valve damage, leading to the deaths of around 500 people, most of them women. The drug remained on the market for years despite early warning signs because it was initially approved as a diabetes treatment and continued to be prescribed even when its dangerous side effects became apparent.

The opening scene showing severe heart valve damage in patient Corinne Zacharria establishes the clinical evidence that Frachon would later connect to Mediator use.

Dr. Irène Frachon, a pulmonologist at Brest university hospital, noticed that several of her patients, including Corinne Zacharria, had severely damaged heart valves despite having no obvious risk factors. Upon reviewing their medical histories, she discovered they had all taken Mediator. This observation led her to hypothesize that the drug was causing the heart damage, prompting her to gather more cases and conduct an epidemiological investigation to prove the connection.

Frachon's sharp clinical eye during the opening surgery scene establishes her methodology for identifying patterns in patient data.

When Frachon and her team presented their epidemiological findings to AFSSAPS (the French health regulatory agency), they faced stiff opposition from Servier's representatives. Despite clear statistical evidence linking Mediator to heart valve damage, regulators were reluctant to act against a pharmaceutical product already on the market. The film depicts the tension between patient safety concerns and corporate interests, with bureaucratic inertia and political pressure slowing the regulatory response.

The earlier scene showing the formation of the research team and their data collection builds toward this confrontation with institutional power.

The epidemiological study conducted by Dr. Frachon and Dr. Antoine Le Bihan was essential because it provided scientific, statistical proof that the heart valve damage was not random but directly correlated with Mediator use. By gathering data across multiple patients and hospitals, they transformed individual clinical observations into measurable evidence that could not be easily dismissed. This rigorous methodology converted bedside concerns into credible scientific data that could be presented to regulators.

The timeline of forming the research team and collecting patient data directly supports the credibility of their final findings.

After regulatory channels proved slow and ineffective, Frachon self-published a book detailing her research and the patient stories behind the cases. Servier responded with legal pressure, attempting to halt the publication because the book threatened to expose the company's knowledge of the drug's risks. The publication also aimed to empower patients and alert the broader public, making it a significant threat to Servier's reputation and commercial interests.

The earlier regulatory setback and Frachon's determination to continue despite institutional resistance sets up her decision to take the fight public.

The investigation revealed that approximately 500 deaths were connected to Mediator, with the overwhelming majority of victims being women. This stark statistic became the driving force behind Frachon's crusade, transforming her personal medical concern into a public health imperative. The scale of the tragedy underscored the gravity of the regulatory failures and corporate negligence.

The film builds toward this revelation as the culmination of years of investigation and data analysis.

Women constituted the majority of Mediator-related deaths because the drug was primarily prescribed as a weight-loss aid to women, particularly overweight diabetic patients. The medication's appetite-suppressing properties made it popular among women seeking to manage their weight, which meant they were disproportionately exposed to the drug's toxic effects on heart valves. This demographic pattern became evident as the investigation compiled data on victims.

The early patient cases mentioned in the film, including Corinne Zacharria, establish that women were the primary recipients of this medication.

A CNAM informant from France's national health insurance fund provided crucial data that strengthened the epidemiological case against Mediator. This health system data allowed Frachon and her team to triangulate their findings with independent, large-scale insurance records, providing additional statistical weight to their conclusions. The CNAM support represented a breakthrough in accessing comprehensive, system-wide information that validated their research.

The timeline shows CNAM involvement coming after media attention and regulatory support had already begun to build momentum.

Anne Jouan, a reporter from Le Figaro, played a critical role in bringing widespread public attention to Frachon's findings. Her journalism amplified the investigation beyond medical and regulatory circles, creating public pressure on authorities to act. Media coverage transformed the story from a specialized medical debate into a matter of public concern, helping to build momentum for regulatory action and keeping the pressure on Servier.

The self-published book and legal battle with Servier created the newsworthy content that Jouan was able to investigate and report on.

The Mediator case exposed systemic failures in pharmaceutical oversight and regulatory processes in France. Frachon's fight highlighted the conflict between market forces and patient welfare, between precaution and speed in drug approval, and between individual courage and institutional inertia. The case led to increased scrutiny of how medications are approved, monitored, and removed from the market, leaving a lasting impact on how patient safety cases are handled in France and beyond.

The concluding timeline points toward ongoing scrutiny and reform in drug safety practices following the revelations.