L’Amavea has filed a criminal complaint in Paris against unknown parties regarding the medication Androcur, linked to tumor development. The advocacy group seeks accountability for negligence in drug safety management, particularly from health agencies and the pharmaceutical company Bayer. The complaint outlines serious allegations, aiming to investigate past failures in patient information and drug distribution. The connection between Androcur and meningiomas has been recognized since 2018, with significant drops in prescriptions noted since then.
The Alarm Raised by L’Amavea
L’Amavea, an advocacy group representing victims affected by Androcur—a medication associated with the development of tumors—has taken a significant step by filing a criminal complaint in Paris against unknown parties. The aim is to highlight the ‘failure’ of those entrusted with ensuring the safety of this drug, as articulated by both the association’s president, Emmanuelle Mignaton, and their legal representative, Me Charles Joseph-Oudin. They stated, ‘It has become clear that the entities responsible for Androcur’s safety, including health agencies, pharmaceutical companies, and medical practitioners, have not effectively managed the drug’s side effects.’
In their official statement, they expressed their desire for a thorough investigation into the negligence exhibited and the accountability of those involved. They have called for the appointment of an investigative judge to oversee this matter.
Details of the Criminal Complaint
The complaint, submitted on Tuesday and made public by AFP, addresses serious allegations including administering harmful substances, causing involuntary harm, endangering the public, failing to report adverse effects, and committing aggravated deception.
Emmanuelle Mignaton emphasized the difference between this complaint and previous compensation-seeking procedures. ‘This initiative is focused on identifying the responsible parties in this situation, understanding who performed their duties correctly, and pinpointing where the failures occurred,’ she explained. The complaint is directed at those accountable for the drug’s safety, with no preconceived notions about the outcome, particularly in relation to Bayer, the company responsible for marketing Androcur, which has been criticized for delays in communication regarding risks and preventive measures.
‘As victims, we seek clarity on why this situation arose. Silence is not an option, especially when so many have been impacted,’ she added, stressing the need for transparency.
Mignaton pointed out that previous civil procedures to obtain compensation have shown that responsibilities are shared among various stakeholders. ‘What we want to uncover now is what went wrong in informing patients more swiftly and how the drug distribution process can be improved to avert similar tragedies in the future,’ she stated.
Historical Context of Meningiomas and Androcur
Why has this action been taken now? According to Mignaton, the ‘failure is now unmistakable’ based on individual claims for compensation that have been pursued since 2018. ‘Our legal team needed these individual cases to assess the possibility of compensation. Expert reports have made it clear that there were significant malfunctions,’ she remarked.
The complaint reveals that reports of meningiomas linked to Androcur have been submitted to the marketing laboratories since 1998. While the drug is intended for treating excessive hair growth, it has been prescribed for a range of conditions, including endometriosis, for many years. The connection between Androcur (cyproterone acetate) and meningiomas was definitively established in 2018. Meningiomas are tumors that form in the membranes surrounding the brain. Although often labeled ‘benign’ due to their low likelihood of becoming fatal, they can lead to severe neurological impairments.
According to Me Joseph-Oudin and Ms. Mignaton, ‘The increased risk, identified by the laboratory as early as 2004, was acknowledged by both the company and the ANSM (French drug safety agency) in 2008/2009. However, no information was conveyed to healthcare professionals or patients until 2019.’ It was only then that ‘the Health Authority and the Laboratory implemented a risk management plan that included targeted information distribution to patients using Androcur,’ they criticized. As of November 2023, prescriptions for Androcur have plummeted nearly 90% since January 2018, with fewer than 10,000 patients undergoing treatment compared to approximately 90,000 at the end of 2017.