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Mammoth French trial begins for drugmaker, regulator in Mediator scandal

Bertrand Guay, AFP | French pulmonologist Irène Frachon poses with a photobook depicting portraits of 'Mediator victims' as she arrives for the trial at Paris’s courthouse on September 23, 2019.

A top French pharmaceutical company and a drugs watchdog went on trial in Paris on Monday over one of France’s largest-ever health scandals. The massive Mediator trial, named for a diabetes drug linked to at least 500 deaths, will last seven months.

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Twenty-three defendants – 11 institutions and 12 individuals – face more than 2,600 plaintiffs in the trial, just some of the 4,981 victims an amphetamine-derived pill by Servier Laboratories marketed as Mediator. Introduced in 1976 for overweight type-2 diabetes patients, the drug was widely prescribed as an appetite suppressant to otherwise healthy people looking to lose weight. Investigating magistrates believe Servier “knowingly hid” properties of the amphetamine-derived drug and deliberately “concealed its harmful side-effects”.

The trial will seek to answer how a drug subject to safety alerts as early as the mid-1990s was allowed to remain on the market in France for 33 years, until 2009, long after it was yanked from pharmacists’ shelves in the United States, Spain and Italy.

Five million people used the product in France over three decades, including three million for stretches longer than three months. At least 500 people are believed to have died from heart problems after using Mediator. Legal experts estimate the drug could ultimately be responsible for some 2,100 deaths.

The pharmaceutical firm, for its part, has maintained it “did not identify the risk” before 2009.

Outsized proceedings

Two overflow rooms have been booked to handle up to 500 members of the public who might wish to attend the trial on any given day. No fewer than 376 lawyers, including 23 for the defence, are involved in the mammoth proceedings, nearly a decade in the making after the complex probe was first opened eight years ago. The indictment alone runs to 677 pages.

“The court is conscious of the sentiments of impatience and frustration… Victims, witnesses and defendants having died in the interim meaning many people will not be able to express themselves,” lead judge Sylvie Daunis said as the trial began on Monday.

Servier Laboratories, which remains France’s number two pharmaceutical giant largely on the strength of sales abroad, has so far paid out more than €130 million in compensation to victims of Mediator.

Charges brought against the firm and nine of its subsidiaries include manslaughter, aggravated fraud, and defrauding social security and private health insurance schemes over the widely prescribed pill. Industry regulator ANSM – which replaced an earlier iteration known as Afssaps in the wake of the scandal – is accused of involuntary homicide and injury by negligence for allegedly acting too slowly to ban Mediator.

Servier’s former number two, Jean-Philippe Seta, and the company’s former secretary-general Christian Bazantay are among the individuals on trial in Paris. The group’s founder, Jacques Servier, died aged 92 in 2014, to the dismay of Mediator victims who said they wanted him to face justice in the courtroom.

Others in the dock include medical professionals who were employed by the firm before, after or during stints working for the industry watchdog meant to oversee the medicines the firm sold. A former senator, Marie-Thérèse Hermange, is the lone politician on trial, accused of complicity in influence peddling after allegedly modifying the final version of a report about Mediator after a visit from a Servier consultant.

The Paris trial will spotlight 91 victims, four of whom died.

Whistleblower, ‘fairytale heroine’

More than 100 witness are slated to take the stand over the 110 days scheduled for the proceedings through April 2020, including whistleblower Irène Frachon, the French pulmonologist credited with raising the alarm over the drug.

In 2007, Frachon sought to confirm her suspicions over Mediator’s deadly side-effects by combing through patient archives in the basement of her hospital in Brest, western France. The result was a 2010 book (“Mediator 150mg: How many dead?”), adapted for the screen in 2016 as the medical thriller “150 Milligrams”. In a weekend editorial before the trial opened at long last on Monday, the left-leaning French daily Libération said Frachon “deserves her status as a modern-day fairytale heroine”, likening the doctor to Edward Snowden, Chelsea Manning and Greta Thunberg.

“This is an essential moment because we have been waiting for this criminal trial for years,” Franchon told reporters on Monday outside the courtroom as the trial began, deriding the firm’s “endless denial of responsibility”.

The Mediator scandal broke the same year as another public health disaster, the PIP scandal, wherein a popular brand of breast implants was found to be using unsafe, industrial-grade silicone instead of more expensive medical-grade material.

Public trust

The scandals spurred a series of measures aimed at patching cracks in the regulatory system. Financing for the pharmaceutical industry was revamped, pushing industry figures out of decision-making processes. An online signalling mechanism now allows patients to flag side-effects of the medications they take. Any gift or advantage that a healthcare professional receives with a value greater than €10 from the pharmaceutical industry must now be declared; the statements are published online for the public to see.

Whether the measures renew public trust in a system shown through scandal to have been short on transparency remains to be seen. Some French experts have drawn a link between public health disasters like Mediator and low levels of trust in health authorities. A report published in June showed France has the lowest level of trust in vaccines globally.

But changes to the system since 2010 may come as cold comfort for victims at the dawn of a seven-month-long trial.

“Servier knew that it was selling poison,” 71-year-old Joy Ercole, who blames the Mediator pills she used for six months for damage to her heart, told AFP. “The unlucky ones, like me, are condemned to a slow death. My life is ruined.”

(With AFP and REUTERS)

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