Androcur file in the telegram of July 6, 2020: "Bayer knew very well that there was a problem in France"

Via its press service, the Bayer group agreed to answer the telegram questions about the drug Androcur.

Why did you wait three years after Professor Froelich's discoveries to change the instructions for your medication? “Following the presentation of Professor's first results of the work of Professor in May 2008 at the European endocrinology congress, Bayer immediately collaborated with the European Agency and the French Medicines Agency. The group has exchanged all the information necessary for the modification of the patient instructions and the summary of the product characteristics intended for health professionals. These documents were disseminated by Bayer to healthcare professionals by mail, with a recall of the exclusive indications of these drugs and the highlighting of the modifications introduced in these documents ”.

Can you send us this mail addressed to professionals? "We reserve the communication of these old documents to the authorities and jurisdictions who would like to have access to them."

How many legal files are there between Bayer and former drug users in France? “The Bayer laboratory received several assignments before the civil courts, including a group action. We reserve our comments to the magistrates who will have to examine these files. But Bayer recalls that Andocur is a drug indicated in France in the treatment of severe hirsutism in women when it seriously sounds on psychoaffective and social life, in the palliative treatment of prostate cancer in humans as well as in paraphilies. "

What are the sales figures for Androcur in France? “We do not communicate on our sales figures at the France level. Only the group communicates on the top 15 drug sales at the world level in the annual report published on the Bayer website. And the Androcur is not part of it ”.

The Androcur multiplies up to 20 the risk of brain tumors.

1980 : Authorization for the marketing of the Bayer laboratories and laboratories, for the treatment of severe hirsutism in women (when it seriously sounds on psycho-affective and social life), in the palliative treatment of prostate cancer in humans, as well as in paraphilies (chemical castration).

2008 : At the European endocrinology congress, Professor Sébastien Froelich presents his first work on the link between Androcur and Meningiomes.

2011 : Bayer changes the instructions for using his medication by indicating the risk of meningiomas.

2006-2015 : More than 500 women are the subject, in France, of surgery attributable to Androcur.

2014 : First European study which formally establishes the link between Androcur and Meningiomes.

2018 : The Minister of Health, Agnès Buzyn, invites patients under Androcur to consult their general practitioner while adding: "There is no emergency, it is not cancer. It is not a health scandal ”.

2019 : 110,000 letters are sent to women on Androcur and liberal doctors. A extremely rare device set up by the drug agency and health insurance. The previous ones: the Mediator and the Dépakine.

This is the story of a miracle drug, capable of treating severe hirsutism, acne, endometriosis or prostate cancer. But the Androcur also multiplies up to 20 the risk of brain tumors. In France, hundreds of women had to be operated on.

This fall morning, "nailed to bed by pain", Emilie could not get up. "I felt like my head was going to explode." Twenty-four hours later, Guingampaise goes painfully to the emergency room. "The scanner revealed that two tumors had caused an edema compressing my brain in its cranial box."

These tumors are meningiomas. Generally non -cancerous, they cause visual disturbances, speech difficulties, epilepsy ... After an MRI, Émilie discovered that she had a "huge mass of 6.3 cm and a smaller, 2.3 cm", at the front and back of the head. Their origin: Androcur, its contraceptive between 2005 and 2019.

"A separate medication, a miracle prescription"

Authorized since 1980 in France, this drug from the Bayer laboratory was initially intended for women with severe hirsutism and men suffering from prostate cancer. Except that the Androcur quickly became "a separate medication" for thousands of women according to Joëlle Robion.

“Unlike some pills, you could prescribe androcur to all women, because there was no cardiovascular contraindication. Faced with a patient with a little too many hairs, acne or weight, it was a miracle prescription, "notes the administrator of the Syngof (National Union of Gynecologists and Obstetricians of France). Between 2006 and 2014, 400,000 French women were thus treated by Androcur.

80,000 women who are warned of risk by mail

However, in 2008, a neurosurgeon, Professor Sébastien Froelich, established the link between the drug and the appearance of meningiomas. Three years later, Bayer changed the instructions for his medication. But sales do not fall. It was not until June 2019, thanks to a letter co-signed by health insurance and the national drug safety agency, that most users discover the risks.

Sent to 80,000 patients, as well as 30,000 practitioners, this letter warns that the medication (whose sales have dropped 70 % in one year) multiplies the risk of brain tumor after six months of treatment and by 20 beyond five years. The recipients are also invited to consult their doctor who "will judge whether or not to perform brain imaging". “It is a very exceptional device; The third implemented after the mediator and excess, "explains Doctor Isabelle Yoldjian, head of the gynecology and endocrinology pole at the ANSM.

As a result of this letter: like Emilie, thousands of women will pass an MRI. How many of them then discovered that the vomiting or the sleep disorders from which they suffered were due to meningiomas? "The figures are evolving every day," replies Dr. Yoldjian, with no more precision.

The lawyer for the victims of the mediator seized

About 200 of these victims are now a member of a victim aid association: AMAVEA. Many fear an operation in the brain, to remove too large or poorly placed meningiomas. According to official figures, between 2006 and 2015, more than 500 women had to be operated on. "Lives can be upset because the risks are very important: loss of language, sight, smell, partial paralysis," explains Emmanuelle Mignaton. She herself operated three times, the president of the association believed to lose the use of speech: "I am still in rehabilitation, several years later".

Represented by lawyer Charles Joseph-Oudin, more than a hundred women have decided to turn to justice to request compensation. “Laboratory responsibility seems to be engaged. By contenting himself with changing his notice in 2011, the information brought to the attention of customers was very insufficient, "explains this specialist in the defense of victims of drugs (Mediator, Dépakine, etc.).

"Bayer did not occur his medication"

“Bayer never occurred to us by his medication, nor pushed to prescribe it. I would even say that the laboratory was the first to warn us about prescriptions outside the marketing authorization, ”says Joëlle Robion with force. The representative of the gynecologists' union adds that "many patients all tell me how much their life was more beautiful with the Androcur".

An assertion that Emilie does not contradict: "It is a medication that brought me a real comfort of life". A comfort of which the forties would have gone well, however: "If an MRI had been prescribed to me in 2011, when I had been taking the Androcur for six years and my meningiomas had to have the size of a coffee grain, I would have immediately stopped. And I would not risk, today, an open head operation ”.

First alert.  “The Androcur was prescribed to me by my gynecologist from 2005 as a contraceptive but above all to treat a hormonal acne. In the summer of 2018, Social Security set up a telephone number for patients under Androcur. It alerted me, I immediately called. But the interlocutor did not seem to know the file and could not answer any specific questions. He simply sent me back to my prescribing doctor. At the time, I already had headache regularly, more frequently and more prolonged than in the past. But also tinnitus and a decrease in vision. I did not make the link with a meningioma potential. I told myself that at 40, it was normal ”.

Androcur? "Dreaded efficiency". “With this alert on the alleged harmful of Androcur, I wanted to stop. I made two attempts, including one very progressive. But each time, I ended up with terrible pain in the belly, inflamed rashes ... I kept two months and ended up resuming treatment. It must be recognized that this drug is of formidable effectiveness and that it brought me a real comfort of life after several pills which did not suit me. For her part, my gynecologist told me not to worry, that the dosage I took was light and that I could continue up to 50 years. She added that lots of patients have been taking Androcur for much longer without it posing the slightest problem. ”

A huge mass of 6.3 cm in the head . “In June 2019, I received a letter from the National Medicines Safety Agency (ANSM) which invited me to get closer to my prescribing doctor and recommended the passage of an MRI. So I returned to see my gynecologist, whose speech had then completely changed: she prescribed an MRI and indicated that I should sign a discharge to continue taking the Androcur in case the results do not reveal meningiomas. But she also told me to continue treatment until examination. On August 13, when I announced the results of my MRI, the radiologist first asked me if I was a epileptic. Surprise, I replied that no. He then told me that I should be, given what I had in the skull: a huge protean mass in the 6.3 cm front lobe and a smaller, 2.3 cm, at the back of the skull. With the mass effect of the biggest meningioma, the axis of the brain was deflected. Which explained headaches, tinnitus and, the front tumor being near the optic nerve, vision disorders. ”

The support of other patients . “The shock of the announcement was terrible. I even had a period of denial: I did not think it was possible to have something in my head this size. I found comfort and precious advice on administrative procedures (including ALD recognition) and the choice of doctors specialized on the Facebook page of the Amavéa association. A formidable page, where everyone shares their doubts, their anxieties but also their hopes. New testimonies of women returning from their MRI arrive almost every day. Some have up to ten meningiomas, smaller, dispersed in the brain. Some others, like me, have meningiomas over 6 cm ”.

In the emergency room . “On September 18, in the morning, I felt intense headaches. Impossible to get up. The pain was nailed to me. I felt like my head was going to explode. Throughout the day, I could only make a phone call, to my employer to warn him of my absence. I couldn't call anyone else. The next day, I was still in the same state. I ended up succeeding in reaching my father, who led me to the emergency room of Guingamp hospital. The scanner I spent there revealed that my two tumors had caused edema, which compressed my brain in the cranial box. I was put under cortisone, which gradually allowed it to absorb it. In parallel, the Guingamp hospital contacted that of Lariboisière, in Paris, to advance my appointment scheduled three months later with Professor Froelich, head of the neurosurgery department. I was able to meet him fifteen days after ”.

The risks of the operation . “What is terrible with meningiomas are the reactions of others. Generally, it is: "Phew, it's not cancerous, so everything is fine!" ». While in fact, these meningiomas, described as benign tumors in medical language, are far from harmless. They can destroy a life. We risk stroke, epilepsy crises ... and, depending on the size and location of these brain tumors, the risks of an operation are major: loss of the use of a member, the view of an eye, speech difficulties ... In my case, if I had to undergo an operation, there would be significant risks of the lesion of motor functions on the right side and impact on that of language. I therefore base all my hopes on the regression of the tumor thanks to the cessation of treatment. If the symptoms are bearable, it is possible to live with it. I don't want to risk being disabled for the rest of my days. Besides, after four months of Androcur stop, my smallest meningioma was clearly narrowed. The most important seems to stabilize ”.

Professor Froelich . " Emmanuelle Mignaton, president of Amavéa , recommended me, given the size of one of my two meningiomas, to make an appointment with him. Head of neurosurgery at Lariboisière Hospital in Paris, he was the one who established the link between Androcur and Méningiomes, in 2008. He set up the victims of Androcur in his service, once a month. He does not operate almost any of his patients, because he found that tumors regressed or stabilized when you stop treatment. It does not consensus within the medical community, since other neurosurgeons operate systematically. He also told me that given the size of mine and the edema they had caused, in another hospital, I would have been operated the next day. ”

I psychote as soon as I come up against a word. "Before, when I had a headache, I put it into perspective, telling myself that it was fatigue or stress. And then, there are few who never have migraines ... Now, I necessarily psychote a lot. As soon as I come up against a word or I have a memory hole, I think Meningioma. It is an almost permanent mental charge ”.

A legal action against Bayer? “For the moment, I am focused on my care path. But then I will have no qualms. They did not have one. They were satisfied with a simple mention at the bottom of the medication manual, which has completely unnoticed in the eyes of all those who use it on the long term. If an MRI had been prescribed to me in 2010, when I had taken the Androcur for five years and my meningiomas must have been the size of a hazelnut and a coffee bean, I would obviously have stopped treatment. And would not risk, today, an open skull operation, epilepsy or stroke. I believe that it is a loss of huge recovery ".