Axelle magazine article by Manon Legrand

Androcur is a drug initially intended for the treatment of prostate cancer, but it is mainly prescribed against hirsutism (excessive development of the hair system) and skin problems in women. He caused a scandal in France after a link was revealed between taking this progestogen and the development of meningiomas (most of the time benign brain tumors) in patients. Since then, the lines have moved. Less publicized in Belgium, Androcur also claimed victims in our country. More generally, this is the question of treatments and the care pathway reserved for women raised by this health scandal.

She had never testified so far, because no one had ever asked her. In France, the Androcur scandal made the headlines. An association to listen and inform the victims has been created, and the Bayer laboratory is targeted by three complaints. In Belgium, it is “radio silence” . “Here, we open his umbrella” , deplores, bitter, our interlocutor.

Françoise has taken Androcur for almost ten years to combat too abundant rules, “oily skin” , the hair loss and the acne she thought, at 40, be definitively rid. The Androcur (Cyproterone acetate, it is also the component of the Diane 35 pill, antiacneic prescribed as a contraceptive decree because of its thromboembolic risks) is a progestogy of the Bayer laboratories. It was initially put on the market for the palliative treatment of prostate cancer in humans, as well as to process by chemical paraphilies (so -called “deviant” sexual behavior). But it is prescribed mostly in women in the treatment of severe hirsutism. The drug is also prescribed in the treatment of endometriosis, but also acne or abundant hair.

Indeed, the Androcur quickly turns out to be “a miracle” . "I told my colleagues to take it ," recalls Françoise. She even advises him to his daughter, who also suffers from cystic acne and hemorrhagic rules. Again, general practitioner and gynecologist confirm to him: "Androcur is ideal". Without ever mentioning potential side effects.

A long mystery

Acne disappears. But other health concerns gradually arise, then more and more numerous and stronger: migraines, vision problems, fiery eyes, dizziness, enormous fatigue. Françoise then continues sleep tests, blood tests, changes glasses every year ... We tell her about “burn out”, “depression”. “I had a depressive episode before: there, I knew that I was not in depression…”

Until today in 2019 when his daughter lets him: "Androcur is a bastard" , articles in support. "It was not" Doctissimo ", she had come across documents from the French Medicines Agency ," said Françoise, who will then see her doctor, tells her about the articles. We prescribe an MRI. Result: a meningioma (a brain tumor, mostly non -cancerous) of 4 cm by 4 has invaded its olfactory bulbs and compresses the optic nerves. "If I do not work, in six months you will lose your sight ," warns his doctor. That day, he recognized for the first time the link between meningioma and Androcur.

• To read / The scale of pain

A health scandal?

In France, the Androcur affair broke out in 2018. “Are we at the dawn of a new health scandal?” , Liberation title in September . The daily reports the publication of an “alarming study” conducted by the National Medicines Safety Agency (ANSM) and Health Insurance. Conclusions worry: Androcur increases the risk of meningiomas in women. This risk can be multiplied by 3, 7 or even by 20 depending on the dosage and the processing time. The progestogen is fixed on receptors that inflate meningioma. This explains why, in a large majority of cases, the stopping of the drug can put an end to the development of meningioma.

The French neurosurgeon Sébastien Froelich established in 2008 a link between Androcur and meningiomas, in patients (women and transgender women) who have been undergoing treatment generally for five years and more. Three years later, Bayer changed his instructions and indicated a risk of tumors there in the event of prolonged use (several years) of Androcur in doses of 25 mg and more " .

In 2019, nearly 100,000 women on Androcur were warned by the drug agency and health insurance and invited to consult their doctor in order, possibly, to carry out brain imagery. The same year, the AMAVEA association was born. Its purpose is to support each potential or proven victim suffering from meningioma. The association also wants to inform the side effects of Androcur, but also synthetic progestins and synthetic estrogens such as chlormadinone acetate (Lutéran) and nomestrol acetate (Lotényl).

Today, in France, things have moved. The Androcur is prescribed under strict conditions: obligation of informed information and consent of the patient, regular MRI (brain imaging by MRI should be carried out at the start of treatment for all patients. In the event of continuation of the treatment, MRI will be renewed after 5 years of treatment, then every 2 years if the MRI is normal).

“It is a half-victory since the out-of-MAM prescriptions [marketing authorization issued for precise pathologies following a global assessment of the balance of benefits/risks and adverse effects, editor's note] are not registered on compulsory information certificates. And the drug continues to be prescribed for pathologies outside AMM” , worries Emmanuelle Huet-Mignaton, president of Amavea She herself a victim of this medicine that has been administered to “treat” her endometriosis.

Low Belgian echoes

In Belgium, few articles have echoed. An RTBF article, however, headlined in 2019 : “The drug Androcur would lead to risk of tumors… only in France?” In the article, our Federal Agency for Medicines and Health Products (AFMPS) is reassuring: “For the moment, in Belgium is not available to data against processing by Androcur. Cancer is not automatically the consequence of drug treatment.”

Since then, the Committee for the Risk Evaluation in Pharmacovigilance (PRAC) of the European Medicines Agency has recommended restrictions on the use of cyproterone due to the risk of meningioma, "a rare risk - it can affect between one and ten people out of 10,000, depending on the dose and the duration of treatment - which increases with the increase in cumulative doses" , specifies the document. "These recommendations apply to Belgium ," says AFMPS.

PRAC recommends that "drugs containing daily doses of 10 mg or more cyproterone be used for androgeno-dependent conditions such as hirsutism (excessive hair growth), alopecia (hair loss), acne and seborrhea (excessively oily skin) only in the event of failure with all other treatment options at lower doses." In addition, even in low doses, "these drugs should not be used in people who have or have meningioma" . And also invite “health professionals to monitor patients to detect the clinical signs and symptoms of meningioma in accordance with clinical practice.” Thus, unlike France, with us, MRIs are not compulsory.

In terms of figures, the Federal Agency reports to have received in the past five years "18 notifications of undesirable effects in Belgium where cyproterone acetate has been designated as a suspect (9 concerned the drug Androcur, the name of the drug is not known for the others)."

Local profits

On the doctors' side, the “risk-risk” argument is advanced when we talk to them about this medication. "Yes, there are risks ," explains Géraldine Brichent, gynecologist at CHR Liège, but fortunately, all patients will not develop meningiomas. When I give Androcur, it is at low doses, generally 5 mg. In Belgium, our dosages are much lower than what French doctors have available. We saw in France that the cases of meningioma were linked to long -term use and Important dosages. It must go through discussion and this is worth for any treatment, ” says the gynecologist who notes that sometimes patients do not dare to ask their general practitioners on subjects still “ surrounded by taboos ” .

Inform, healthcare professionals do not systematically do so. As we already wrote for other health issues - the IUD Mirena for example ( reread here our article on this subject ) or cardiovascular disease -, women are not only little informed of side effects and, when they relate to their doctor, they often get to say that it is in their heads ...

However, Françoise, like most of the women concerned who testify on the site of Amavea and in the French press, confides: "We would have made other choices if we had been informed." It is for this reason that the AMAVEA association has released a prospectus to inform women around the link between cyproterone and meningiomas acetate, but also around other progestins (see below).

Other choices, are there really? "There are a lot of different progestins, but when we look at literature, they are all affected by the risk of meningiomas ," replies Géraldine Brichese. “We then try to adapt the therapeutic indications and prescribe the one who presents the least risk for the patient.”

“Hormones with a shovel”

“I prescribe hormones with a shovel,” warns Jean Vandromme, gynecologist at the Saint-Pierre CHU, specializing in menopause and transitions. "In the vast majority of cases, we are talking about patients with big, big problems, to whom we prescribe Androcur. And there are no alternatives, so what are we doing? Seeking and monitoring patients, that makes sense. To stop prescribing is also mistreatment ," said the specialist.

It is very reassembled against the excessive media coverage of the case in France and the drastic fall of the prescriptions which followed. "It is the same thing that happened with the pills . Result, it is the war with hormones. We advocate the" natural ". Now, there are women who can do without it, and others who are really not good without" , continues Jean Vandromme.

• Read / contraception: where are men?

Poorly treated women

"The problems to which the Androcur can answer can create a social handicap, we do not question this treatment. But the Androcur was initially created for men, against prostate cancer. And that, it asks questions ..." , lights up for us Delphine Bauer. With Ariane Puccini, the two journalists wrote the work Mal Treatments. Why women are poorly treated , which looks back on several health scandals in France having in common to concern the vast majority of drugs prescribed to women.

"Androcur is the tree that hides a huge forest. Medicines, despite their apparent neutrality, are social objects crossed through gender, from their design to their marketing, from their dissemination to their prescription ," said the authors. With the consequence that women are mostly among the victims of side effects.

Lack of research, studies and funding for drugs deemed “not profitable”, women underrepresented in clinical trials (even laboratory rats are mainly males!), Information defects, non-listening to patients ... The causes of health inequalities are numerous. So many elements that also show us that the famous balance of risk benefits is neither neutral nor immutable.

The survey of Delphine Bauer and Ariane Puccini also highlights the social injunctions that weigh on women and which promote the prescription of certain drugs. Androcur for acne, the mediator to lose weight, but also contraception, still mainly based on the shoulders of women who are therefore alone to wear the “risk”…

"We notice that there is social pressure to enter the canons that make women take these drugs. And when it goes wrong for them, they are told that it is a little futile to have risked their life for weight problems, hair, etc. It is the blame of the victim ," observes Ariane Puccini.

• To read / medicine: feminine or masculine genre?

Live with vulnerability

An operation later - and a much longer convalescence than expected -, Françoise suffers today from great fatigue linked to the damage made by the tumor on vision, balance, memory and concentration. She must now live with her vulnerability, accept renunciations, confront those who do not understand it, put on "you are no longer capable" and the implied felt as "you are lazy" , "is a benign tumor" , "because what is scientifically benign-that is to say non-cancer-does not mean without heavy sequelae" , she recalls.

She found information on the Amavea site, but also support and necessary solidarity. “ I would have liked to launch an association like that in Belgium, but I do not have the energy.” Françoise does not want doctors. “They are not gods, they cannot master everything.” But she rages to see the Androcur still prescribed “wrongly and through” . The culprit, she said, is Bayer: “Yes, they talk about meningioma on the instructions, but they minimize.”

Note of hope: Delphine Bauer and Ariane Puccini find that “more and more women are now enlisted in clinical trials, even if there are still disparities according to illnesses, things also move on the side of women researchers and doctors.” Their work, if he does not shake pharmaceutical firms, gives, informing, weapons to (future) victims.

Facebook Twitter Email