https://www.streetpress.com/sujet/1699539108-scandale-sanitaire-femmes-victimes-omicament-androcur-condamnation-etat-france-ansm
Health scandal: women victims of the drug Androcur ask for the conviction of the state and the Bayer laboratory
This day article thanks to the request of the association of the association, to journalist Camille Grange.
Nothing is done on its own (for those who still have doubts ...)
Nothing is done on its own (for those who still have doubts ...)
Health scandal: women victims of the drug Androcur ask for the conviction of the state and the Bayer laboratory
Three drugs prescribed against endometriosis or abundant rules have caused Isabelle, Nathalie, Emmanuelle and other brain tumors. They would like to condemn the state for lack of information.
On the phone, Nathalie stumbles on certain words. One of the consequences of the operation of a meningioma, a meninges tumor , the brain envelope. The 54 -year -old computer scientist can no longer drive. Since the removal of the tumor, she has been put in the closet by her employer. His reflexes are no longer the same:
“I am disabled today. It completely changed my life. »»
For 12 years, Nathalie took Androcur, a drug from Bayer laboratories . The hormonal treatment was prescribed to treat his acne. In 2017, meningioma was diagnosed. A neurosurgeon would have advised him to stop the medication. “On the left part of my face, I had a bump on the temple and the eye that came out a little. For years, she has "fought" from Aspegic and Dafalgan because of headache. Isabelle (1), in his fifties, also took Androcur for 15 years, to deal with problems of menstruation and hair. She too has developed meningiomas:
“The operation of removing the tumor had consequences on my mood: I hardly manage my emotions, I am in extremes. »»
The SNCF controller was demoted to the counter after a two -year work stoppage. “For several years, I was not able to raise my twelve year old son. My husband had to take care of me daily: washing me, making me eat, driving me. The moments of life I lost are not recoverable. »»
In July 2019, Epi-Phare, a group of scientific experts created by Health Insurance and ANSM, responsible for assessing the potential health risks of drugs, validated the link between the taking of Androcur and the occurrence of meningiomas . The treatment is strongly dosed in synthetic progesterone. The hormone, naturally present in the body, plays an important role in regulating the menstrual cycle and pregnancy. Initially indicated in the treatment of hirsutism - too much hair - and prostate cancer, Androcur has also been prescribed for endometriosis, acne or even polycystic ovary syndrome.
The health authorities today believe that the risk of meningioma surgery is multiplied by 24 if you take Androcur . Epi-Phare adds to this first report that many meningiomas have shrunk after stopping treatment. In 2021, the risk was also proven for two other progestins of the same family as this medication: Luteran , produced by Sanofi, which increases the risk by 5.5, and the lutenyl of the Theramex company, which increases the risk by 7.5. Over a period from 2009 to 2018, Epi-Phare identified 2,124 cases of operated meningiomas attributable to the taking of these three treatments . According to the ANSM, 7,900 people used Cyproterone acetate, the Androcur molecule, in high doses in December 2021.
Nathalie, Isabelle, but also Marie-Hélène, Emmanuelle and a dozen other women are organizing at the moment to file a request before the Administrative Court of Montreuil to have the responsibility of the State and the Bayer laboratory recognized in the damages they suffered . "So that this does not happen to other women and that the managers are appointed," explains Isabelle, determined. Streetpress asked the ANSM, Théramex, Sanofi and Bayer for this article. Only the latter two answered our questions.
Isabelle took Androcur for 15 years to deal with menstruation problems. In 2009, affected by powerful migraines, she had come to pass a simple cerebral scanner. We discover a meningioma "the size of a grapefruit". / Credits: Marine Joumard
A request to assert "only risk suspicion"
Since the diagnosis of her meningioma, Isabelle has noted each step in a notebook. The first took place in 2009. Assigned by powerful migraines, she had come to pass a simple cerebral scanner, accompanied by her husband and her twelve-year-old son, "as we pass a radio from the feet," she describes. However, she will not leave the hospital after the exam and will have to be operated on in an emergency. Five days before Christmas, the doctor informs her husband that a meningioma was spotted on the radios. "Prepare for everything ," he said. The tumor compresses its brain and optic nerve. The concerned comments:
“At three days old, I lost my sight. My meningioma was the size of a grapefruit. »»
From 2000 to 2016, Isabelle took Androcur to treat primary amenorrhea - an absence of rules -, and her hirsutism. When he left the block in 2009, Isabelle was prescribed again from Androcur. She takes it for an additional seven years. In 2016, when she talked about her operations and her headache during an appointment, her gynecologist the sum of stopping treatment .
"In 2004, there were already pharmacovigilance reports towards these treatments," said Maître Charles Joseph-Oudin, the lawyer for Isabelle and the 14 other complainants. According to him, the responsibility of the State begins in 2008, the date on which a study is carried out by Professor Froelich, neurosurgeon at the Lariboisière hospital in Paris. The latter would have observed a link between taking treatment and the occurrence of meningiomas in transgender women - the drug slows down testosterone production and blocks the development of sex hormones responsible for so -called male characteristics. “It is case law in the Mediator case in particular: the only suspicion of risks is enough to give rise to an obligation of information . The penalty accompanied victims of the famous mediator, this antidiabetic which caused serious cardiovascular problems in thousands of patients and is responsible for hundreds of deaths . He still works today for the recognition of the rights of the victims of Dépakine , an antiepileptic responsible for malformations and developmental disorders in children. For him, the Androcur is "in line" of these two other health products affairs. Asked about it, Bayer did not wish to comment on this declaration.
"We are faced with a health system-the authorities and laboratories-which does not understand the concept of a public health policy based on the emergence of a weak signal," said Maître Joseph-Oudin, the lawyer for the complainants. / Credits: Marine Joumard
According to the lawyer, the information would have been given to women and doctors until 2018 , ten years after the study of Professor Froelich's study. "We are faced with a health system-the authorities and laboratories-which does not understand the concept of a public health policy based on the emergence of a weak signal," protests Maître Joseph-Oudin. On the Androcur, he adds:
“Doubt benefited the drug and the firm, not the interest of patients. »»
“It is not a health scandal. »»
The first judicial expertise was launched in May 2018. The same year, Agnès Buzyn, then Minister of Health, declares on CNews, however, that the situation is not urgent: “It is not cancer. It is not a health scandal. Five years later, Me Joseph-Oudin hopes that the administrative judge will condemn the ANSM and therefore the State, responsible "100 %" for the damages suffered by his clients. “I intervene for women who suffer or have suffered from meningiomas, who have not been informed of the risk. The information obligation was not respected. It leads to a responsibility of the State and the laboratories, and compensation for patients , ”explains the lawyer.
However, some women feel disappointment for this request. "In my opinion, more than the state and the health authorities, it is Bayer who must be recognized as responsible . They should have studied these side effects in 2008, at least, ”denounces the computer scientist Quinqua Nathalie. In the event of a conviction, a state charge, representative of the ANSM, to turn, then, against the laboratories to obtain a reimbursement of the party which does not fall. A similar request should be made for the Lutéran (2) of Sanofi and the Lotényl de Théramex in the coming weeks, products from the same family as the Androcur.
In 2018, Agnès Buzyn, then Minister of Health, said that the situation concerning Androcur is not urgent: “It is not cancer. It is not a health scandal. Five years later, Me Joseph-Oudin hopes that the administrative judge will condemn the ANSM and therefore the State. / Credits: Marine Joumard
Because Androcur is indeed not the only one to have done damage. For five years, Marie-Angèle took Luteran to stop her hemorrhagic rules-very abundant bleeding during menstruation. In January 2019, a meningioma stuck to his optic nerve was diagnosed with him, as was the case for Isabelle. Now 51 years old, she has undergone eight operations . Her skull having misunderstood heal after surgeries, she lives with a valve of derivation in the head, which allows the liquid to be evacuated around the brain and produces in too large quantities. She will have to keep her for another three years. In the meantime, impossible for her, for example, to pass an MRI to solve a problem diagnosed with a breast. There are other consequences, she said:
"Hormone taking is no longer possible after meningioma, my uterus was removed to prevent me from suffering from these hemorrhagic rules again. Fortunately, I already have three children. »»
"No risk suspicion in 2006"
In the medical expert report of one of the complainants that StreetPress was able to consult, the experts appointed by a judicial court believe that the dates prior to 2008 advanced by lawyers "have no justification". "There is no" beam of plausible and constant arguments "in 2000," they say. Experts also support the will of the Bayer laboratory to change the notice in December 2008 in a letter addressed to the ANSM (at the time, Afssaps). "On July 7, 2009, the Bayer Healthcare laboratory sent a letter to the ANSM informing it that he had not received a response to its request for modification of December 18, 2008 consisting in the addition of the mention of" benign brain meningiomas "in section 4.8 of the product characteristics (document intended for health professionals, editor's note)", they add. This change in the notice would therefore have served as clear information delivered to women . Nathalie is sorry:
"But patients who have been taking treatment for a long time do not read the instructions!" And then, if we read the side effects on the notices, we do not take any medication. »»
By email, the laboratory recalls that the therapeutic interest of this molecule was again confirmed by the authorities in 2020 .
The medical expertise reports, however, provide a new security for complainants by validating legally, and for each file, the causal link between taking medication and meningiomas . “This is an essential and essential step, which will allow us to move to the evaluation of damage. No causality in expertise, no file before the judge, ”recalls Charles Joseph-Oudin.
The consequences of these drugs were dramatic for women. Marie-Angèle took Luteran to stop her hemorrhagic rules. She has undergone eight operations and must live with a derivation valve in the head for another three years. / Credits: Marine Joumard
In his response to Streetpress, Bayer specifies, that in his knowledge, no new study is underway.
“If the letters had been sent in 2011, we would have avoided cases. »»
In 2019, Nathalie co-founded the AMAVEA association (3) to educate women about the risks of meningiomas. “The sufferings, the damage and all that we have experienced must be recognized. Convicing the State is certainly a good thing - the expert reports point to the responsibility of the ANSM. But the laboratories, in my opinion, have not done their duty of information, ”says Emmanuelle Mignaton, the other co-founder. In 2017, the latter was made of five meningiomas following the taking of Androcur and Lotényl to alleviate the pains linked to its endometriosis. Then, one day, his right hand paralyzes, his leg shies away under his steps. Language disorders appear. Emmanuelle is forced to leave work at the Banque de France . She divorces. "I felt like something was growing in my head," she describes. After the operation, she can no longer speak. His physical and speech therapy rehabilitation lasts several months. “In the report concerning me, experts only recognize damage from 2017, the year I was made. However, my life has changed long before, ”she defends herself.
The fight of Amavea allowed, as early as 2019, the sending of mail to prescribing doctors to inform about the risks of meningiomas for Androcur, and from 2021 for Lotéran and Lotényl. Today, patients and doctors must sign a discharge acting as information on risks with each prescription of the three treatments. This clarification of information has dropped the number of prescriptions from cyproterone acetate . While in January 2010, nearly 85,000 people used the high dose molecule, they were only 8,000 in December 2021.
"If these letters had been sent in 2011, we would have avoided cases ," regrets the former financial analyst. According to her, the steps were more full -bodied for Lotéran and Lotényl:
"Gynecologists told us that it was going to" panic women ". This is a situation that stands out for us. You have to know how to pass the information fairly. »»
(1) The first name has been changed.
(2) Contacted, the Sanofi laboratory specifies that Lutéran has not been marketed since October 2020.
(3) Méningiomes association due to cyproterone acetate, victims assistance and taking into account other molecules.
(2) Contacted, the Sanofi laboratory specifies that Lutéran has not been marketed since October 2020.
(3) Méningiomes association due to cyproterone acetate, victims assistance and taking into account other molecules.
