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Levothyrox: Merck lab charged with ‘aggravated deception’ – Science et Avenir

This is a new aspect in the Levothyrox case: the French subsidiary of the German pharmaceutical company Merck was charged with “aggravated deception” in a 2017 reformulation case for a thyroid drug.

Four and a half years after the opening of a criminal case in Marseille, in March 2018, this decision was greeted with satisfaction by lawyers and representatives of associations of victims of this drug, used daily by 2.5 million patients in France, reports Merck.

“The president of Merck in France was heard” on Tuesday at the medical center of the Marseille court, and Merck was charged with “aggravated deceit,” the group said in a press release on Wednesday.

Information confirmed to AFP by the Marseille prosecutor’s office that Merck Santé SASU was placed “under judicial supervision” with a €4.3 million bail and a €7 million guarantee.

The allegation is related to “information procedures implemented during the transition from the old formula to the new one in 2017” for this hypothyroidism drug, the company added.

“The judge ruled out the most serious offenses – bodily harm and manslaughter, as well as endangering the lives of others – in order to preserve only shortcomings in terms of communication,” Merck’s lawyer in the criminal prosecution of Me Mario Stazi insisted to AFP, ensuring that “the quality of the drug is not is being talked about.”

“The investigation is ongoing in relation to all persons mentioned in the disclosure of judicial information,” the Marseille prosecutor’s office said.

According to Me Stazi, “Merck developed this communication plan with various partners, experts and in dialogue with patient associations, and under the guidance of the Medicines Agency (ANSM, editor’s note), which approved it.”

– “Good medicine” –

At the heart of this case is a new formulation of levothyrox that arrived in France at the end of March 2017 using the same active ingredient, levothyroxine, but with new excipients.

However, patients complained of many side effects: seizures, headaches, dizziness or hair loss. A petition demanding the return of the old formula has collected more than 170,000 signatures.

The announcement of the indictment was welcomed by Marie-Odile Bertella-Geffroy, a lawyer representing about 3,000 levothyrox patients: “We thought it would never happen. My clients no longer believed in it. Finally, it’s up and running.”

“This is a stage victory awaiting trial,” said Me David-Olivier Kaminsky, representing about 200 victims, for whom the lab “acted as if nothing had happened, ignoring the pain of the victims.”

“The chapter of aggravated deception is already quite good. Merck should never have introduced a new formula (…) without an alternative. They knew they were in danger of throwing patients off balance,” responded Beata Barthes, president of the Living Without Thyroid Association.

“It’s a good start,” but “it shouldn’t be a false accusation,” said Chantal L’Hoire of the French Association of Thyroid Patients (AFMT), for whom “contrary to what Merck continues to claim, (… ) it was this new formula (levothyrox) that was directly responsible for this health scandal.”

– “Lack of vigilance” –

In June 2019, ANSM, the French national drug safety agency, conducted a study of more than two million patients and concluded that switching to the new formula did not cause “serious health problems.”

The agency is now the target of a class action lawsuit by some 1,100 plaintiffs for “lack of vigilance” and “lack of waiting.”

In another civil case, the Court of Cassation rejected in March an appeal by Merck, which was sentenced in 2020 to pay compensation to more than 3,300 users who suffered side effects after the formula change.

In France, less than 100,000 patients are being treated with the old formula imported to France since the end of 2017 called Euthyrox. Distribution of the old formula, which was supposed to end in 2020, has been extended until at least the end of 2022.

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