Reception > News > Article of the World of March 29, 2024: “The victims of the Androcur and the progestogen pursue the State in court to be compensated”

April 28, 2024

Article of the world of March 29, 2024: “The victims of the Androcur and the progestins pursue the State in court to be compensated”

The victims of the Androcur and the progestogen pursue the State in court to be compensated

Two requests were filed before the Montreuil administrative court. The drug agency is questioned for having been slow to properly inform patients of the risk of brain tumors despite the alerts.

https://www.lemonde.fr/planete/article/2024/03/29/les-victimes-de-l-androcur-et-des-progestifuxe-poursivevent-l-etat-en-justice-pour-etre-indemnisees_6224790_3244.html

After the victims of the Mediator and the Dépakine, it is the turn of those of the Androcur and the other progestins (Lotényl, Lotéran ...) to ask the State accounts. According to information from the world , two first requests were filed on March 7 before the Administrative Court of Montreuil, in Seine-Saint-Denis, a department where the National Agency for Medicines (ANSM) is installed. They aim for the Ministry of Health, in order to obtain compensation respectively 748,777 euros and 361,515 euros. About fifty appeals are in preparation on 450 files identified to date. They are based on medical expertise that calls into question the late reaction of the health authorities, despite alerts, to properly inform the risks of meningioma (brain tumor) linked to these hormonal treatments derived from progesterone. Contacted, the Ministry of Health and the ANSM did not wish to comment.

Initially developed against hirsutism, the Androcur (trade name of cyproterone acetate) is a medication that inhibits male hormones. Produced by the Bayer laboratory, marketed since 1980, it has been massively prescribed for women against endometriosis, acne or as a means of contraception. It can also be given to transgender people for its antiandrogenic properties.

At the origin of one of the two appeals, Céline A., 50, who wishes to keep anonymity, took it between 2010 and 2016 on the advice of her gynecologist: “No one warned me that my life could switch because of a simple pill. " Her life" tilted "on September 8, 2016. Following a car accident and the persistence of intense cervical pain and tremors of the left arm, she performs a brain magnetic resonance (MRI) imagery: the examination highlights three meningiomas. The biggest, the size of a clementine , is removed in an emergency. Eight years later, she can no longer drive or work due to headache, concentration and balance disorders or reduced visual acuity. And lives with "a sword of damocles above the head" : two meningiomas to monitor and the "fear" of a new risk operation.

Before being able to seize the administrative judge, Céline A. had to lend himself to a long medical expertise in the context of legal proceedings of "referral". The final report, dated from October 2022, which the world was able to consult, leaves little room for doubt: "the causal link between pathology and the symptoms presented (...) and Androcur are recognized" and "cannot be attributable to another cause" . The document is just as clear on the ANSM's reaction: "It seems illogical that the prevention measures were only taken from 2018" while the agency itself indicates on its site that "the risk was established in 2009" . The first pharmacovigilance alert dates back to 2004, with five cases of meningiomas of patients treated with cyproterone acetate. And the risk was "proven" in 2007, according to experts. That year, a first scientific publication, of the neurosurgeon Sébastien Froelich, was sounding the alarm and the Bayer laboratory itself signals the "higher risk of meningiomas in cyproterone acetate users" .

"Very serious pathology"

However, "it was only over October 2018-2020, while more than 20 publications were published on the subject and more than 500 cases of meningiomas in patients treated by cyproterone cyprotate had been declared (which is enormous in view of the very low incidence of meningiomas) that the appropriate measures were taken with a risk management plan", notes the expert report.

At the end of August 2018, the ANSM made public a study conducted by the National Health Insurance Fund from 400,000 women who took cyproterone acetate between 2006 and 2015: it shows a risk of meningioma "multiplied by 7 for women treated by a dose of 25 mg per day over six months and by twenty after five years of dose of 50 mg per day" . In September 2018, the agency sends a first mail to health professionals to tell them not to prescribe the molecule in the event of existence or history of meningioma and to stop treatment in the event of meningioma. A month later, she recommends this time to establish MRI screening. In May 2019, the agency published an informative brochure for patients. In June 2020, the need to practice an MRI at the start and under treatment was added to the marketing authorization. Since then, Androcur's prescriptions have dropped sharply. According to the latest ANSM data, less than 10,000 people were still processed in Androcur at the end of November 2023 against 90,000 at the end of 2017.

The report is also surprised that "the notion of benignity of the tumor persists in the information instructions" of the drug after being introduced in 2011. Meningioma is presented as a "generally benign tumor" of the brain. For experts, the word "Benin" - which means in medical language that the tumor does not metastasize - is "unsuitable" to qualify a "very serious pathology" and has "nothing to do" in a notice intended for patients because it "does not reflect the seriousness of meningioma" .

"A fault of the health authority"

“This affair of progestins is a major public health scandal. For years, thousands of women have been exhibited at very large doses of a product, which is however suspected of creating very serious brain tumors , "comments Charles Joseph-Oudin, Céline A law. In his office, a room is devoted to each case: Mediator, Dépakine, and now around 450 files related to progestins. For the lawyer, the three cases have "strong similarities" . “The drug agency and laboratories were informed of the risks. But it took more than ten years for prescribing doctors and patients to be properly informed of the risks linked to Androcur, said M ^e Joseph-Oudin. This delay in the issuance of precise and detailed information constitutes a fault of the health authority. A deficiency already recognized by justice within the framework of the trials brought by the victims of the Mediator (2014) and the Duskine (2020) .

For the president of the association of victims of meningiomas linked to drugs Androcur, Lotéran, Lotényl, Colprone, Surgestone and other progestins (Amavea), Emmanuelle Huet-Mignaton, "this fault must lead the Ministry of Health to set up a compensation device as was done for the Mediator and the Depakine" . For M ^e Joseph-Oudin, the state, then, to the State, to turn against the laboratory, also implicated in the expert reports. In another procedure, a first trial targeting Bayer was scheduled in April 2025 before the Poitiers court.

"The victims, some of which have lost their jobs or are today at the RSA, must be compensated for the damage they have suffered," says Emmanuelle Huet-Mignaton, still prey to "sneaky fatigue" after being operated with a meningioma "big as an orange" and two and a half years of "torture sessions" Interlocutors. How many victims of progestins? Five years after its creation in January 2019, AMAVEA has nearly 900 members. Officially, the ANSM identified 500 people operated on meningiomes between 2008 and 2018 for the Androcur alone. "Given that five other risky drugs have been identified, it is already at least 3,000 people over this period ," said the association's president, who says he has received more than 5,000 testimonies.

Stéphane Mandard