Victims of an antipilosity medication continue the Bayer laboratory

This is a first: three victims of Hormonal androcur treatment attack the German giant Bayer, also a happy owner of Monsanto. They assign this manufacturer of an antipilosity drug before the Bobigny tribunal de grande instance for lack of information on the risks incurred: the appearance of brain tumors called meningiomas. This Tuesday, the hearing was set for May 29.

“It is not only public money that should be used to compensate. The laboratory must pay , ”justifies Emmanuelle Huet-Mignaton, president of the Méningiomes association due to cyproterone acetate, aid to victims and taking into account other molecules ( AMAVEA ), which has impulses legal action since its creation on January 26.

© DR

The doctors she consulted for her endometriosis - this disease which makes the rules extremely painful - prescribed this pill which, taking it continuously, stops bleeding. Moreover, 15 % of Androcur's boxes are sold for "the care of contraception" , according to the High Authority for Health. Worse, 30 % of orders are linked to acne, tells us health insurance. And only 15 % - or half as much - to excessive hair.

This is the only reason for the three for which Androcur is authorized to be marketed since 1980 in France. The drug is therefore massively diverted from its primary use, to the point that 89,000 French people took it in 2017, according to the latest official figures.

Emmanuelle Huet-Mignaton swallowed from 2003 to September 2017, when her five tumors were identified at MRI. One clearly distinguishes one of them, a white spot as large as an orange.

As soon as her medical file is complete, she will join the complaint. Because since she fully found the use of speech in April 2018, she defends the collateral victims of this treatment.

90 % of meningiomas are mild, of course. "It is not cancer ," had clumsily shortened Agnès Buzyn, Minister of Health, on September 13, 2018 on CNews , "this is not a health scandal" ^[1] .

Health insurance, however, officially attributed the appearance of brain tumors to this cyproterone acetate drug in at least 500 women just in a decade, from 2006 to 2015. While it has been sold for 39 years in France.

The fact that the growing brain tumor puts pressure on the nerves. And there lies the real danger. Because it alters the essential functions of the body. But to remove the tumor is a risky operation. In any case, many patients with meningioma have become epileptics, have lost their capacity for speech, memory, balance, suffer from tinnitus, headache ...

Nina ^[2] , dental surgeon, almost lost her sight. During the interview, it is impossible not to notice a ball nestled behind her left eye, as if she had stored violently. Except that this is a tumor. The operation did not allow it to be extracted in full, as it spread around the optic nerve.

By discovering the extent of the damage to the MRI, the first question of Nina's radiologist was: "Do you take Androcur?" 2003 to 2011. Until Bayer adds to the notice a few lines lost in a usual flow of contraindications on this risk of meningioma ^[3] , at the request of the European Medicines Agency.

And this, following the publication in 2008 ^[4] of suspicions of links between Androcur and the appearance of brain tumors by the team of the neurosurgeon Sébastien Froelich, of the Lariboisière hospital in Paris. This makes Charles Joseph-Oudin say, the lawyer for the three victims who attack the first manufacturer of the drug, that "Bayer had known the risks of Androcur at least since 2008" .

This is why he continues the pharmaceutical firm in civilian, for lack of information on the risks incurred and "defect" of the drug. Exactly as he had done against Servier when the Mediator scandal broke out (already, at the time, doctors had diverted the use of the anti-diabetic drug to prescribe it as the appetite suppressant, without reassessing the famous benefit/risk balance and thus provoking between 500 and 1,500 dead); Then, more recently, against MSD . Bayer simply tells us "not to communicate on current or future procedures" .

The National Medicines Safety Agency (ANSM) and the National Office for Compensation for Medical Accidents (ONIAM) are also assigned, the lawyer says.

Nina pharmacovigilance declaration. © DR

Nina hesitates to join the sixty patients who already have an Androcur file in the Dante law firm. Eight years after her brain operation, she sees perfectly but she struggles to obtain loans to enlarge her cabinet and insurance refuses to cover her for her tumor: in the event of a recurrence, her house will also be on sale.

Androcur is mainly presented as a magic pill in case of excessive hair or acne

The marketing authorization (AMM) of the drug is clear. It provides that this tablet is prescribed in humans in the event of prostate cancer or "chemical castration" for sexual assaults, and in women, hirsutism .

This barbaric word actually means "appearance of a hair in so -called male areas, normally devoid of hair in women (face, chest, back, buttocks, anterior face of thighs, etc.)" . A hair "composed of thick and drushed hair" corresponding to the highest scores of the diagnostic test .

Nothing to do with a slight down, three hairs under the chin or velocated arms. Especially since the authorization to sell the Androcur clearly specifies that the ordinances must only concern the "cases of major hirsutism, when they graze seriously on psycho-affective and social life" . Now the flirtatious nina, short pepper and salt cut, is not a "beard woman" . On the forums , Androcur is mainly presented as a magic pill in case of excessive hair or acne. Virtues that explain its success with women with polycystic ovaries and hormonal disturbances that go with it, like Nina. Gynecologists are the first prescribers of Androcur or its generics, in nearly six out of ten cases.

Especially since the treatment is reimbursed! "It is only for a question of health economics, health insurance should take stock when the number of prescriptions is so exaggerated in relation to its primary function ," said the dentist. Any woman is tempted to take a miracle pill which gives her beautiful skin and less hair ... especially when she is not aware of the dangers. »»

"Cyproterone acetate works very well for acne, but it is a nuclear bomb ," said Alain Weill, head of the public health study department of the National Health Insurance Fund that had supported Irène Frachon, the Mediator whistleblower. He just looked at the data closer from 2016. And teams up with the researchers from the Lariboisière hospital who had sounded alarm eight years earlier.

Together, they carried out a major study carried out on 250,000 women exposed to cyproterone acetate for seven years. In August 2018, the shock results were partly revealed: this high -dose molecule exposes to a risk of meningioma multiplied by seven! And even twenty in the event of prolonged treatment beyond five years^[5].

Since then, pharmacists have sold almost half as much of Androcur boxes or its generics, according to our information. But there is still room. France is the first consumer in Europe. France represents 60 % of Androcur sales or its generics in the five countries (France, therefore, but also Great Britain, Italy, Germany and Spain) where they are available in pharmacies.

France is also the first victim: it is affected by 80 % of cases of meningomes linked to cyproterone acetate, according to the ANSM documents.

How to explain these massive prescriptions in France, outside the nails? The pill was also given there until April 2018 to transgender people, and even at the maximum dose of 100 mg, thus increasing the risks ^[6] ... by reducing male hormones, it erases male characters, as its name suggests: Andro, of the Greek "man"; Cure, from Latin "care".

In addition, this is not the first time that gynecologists, first prescribers, have been implicated. They have already been for their massive ordinances of so -called third generation pills, at the end of 2012. And in particular Diane 35, also produced by Bayer.

Diane 35 was first withdrawn from the market; Since August 2013 , she has found a place on the shelves of pharmacies, only as anti-acne. Now Androcur contains the same molecule as Diane 35, Cyproterone acetate, therefore, "but in doses of horse" , specifies M ^e Joseph-Oudin. Twenty-five times more.

In reality, the health scandal of third generation pills and that of Androcur are linked. 5 % women suffer from polycystic ovaries and 10 % drool with endometriosis . If, as a bonus, these patients are subject to cardiovascular risks, gynecologists no longer prescribe third generation pills to relieve them. Too risky.

They therefore relate to Androcur or other derivatives of less dosed progesterone. If gynecologists are so uncomfortable on the subject, it is because alternative remedies are still lacking. "For endometriosis, the only current drug treatment is to block the rules, especially with progestins ," justifies Horace Roman, an expert gynecologist.

Better inform doctors of dangers against pharmaceutical lobbying

This "therapeutic impasse" also explains why the health authorities do not remove this hormonal medication from the market, despite its risks.

Stéphanie's tumor was the size of a clementine. Nurse by profession, she wants Bayer who "has not informed enough about the dangers of gynecologists like mine, who prescribed Androcur for my polycystic ovaries " . The German laboratory, which refuses to indicate to Mediapart the turnover made on this medication, is the first winner of this surprise ^[7] .

"The medical visitors that I see parading in the hospital are salespeople, they do not insist on the undesirable effects to sell their products! » , Notes the forties. "Bayer will not organize a conference" Méningiomes et Androcur "" , quips Geoffroy Robin, gynecologist at the Lille CHRU, commissioned to answer our questions by the National College of French Gynecologists and Obstetricians (CNGOF).

This college is one of these learned companies led by the largest stars in each field and in whom specialists have fully confidence. They also had to alert to the dangers. Their role as prescribers of prescriptions makes it a privileged target of lobbying of the pharmaceutical industry.

However, the German giant is directly funding this most famous gynecologists' club. "Bayer is a historic partner of the CNGOF, with support which varies between 30,000 to 40,000 euros per year ," admits the pharmaceutical company.

On December 6, 2018, during the annual high mass of the CNGOF, the first warnings on Androcur were relayed. It is Geoffroy Robin who sticks to it. While he is not even able to apply them all. He thus confides that he cannot call all the women to whom he was prescribed from Androcur in his service, "for lack of computerized files" ...

In a letter sent in October, the drug agency, however, specifically asked healthcare professionals to contact their patients currently under treatment, in order to "re -evaluate the need to continue" ^[8] . And to proscribe the indications in the event of moderate hirsutism and acne.

In December 2018 , the ANSM also promised "the rapid implementation of an annual care agreement" , which is still not existing, but which is now announced for early May, according to our information. It will be a certificate of information that doctors and patients will have to sign, mentioning this endless effect, for each prescription from Androcur, history that everyone thinks twice.

Another letter should be sent to healthcare professionals by the end of June. The "drug gendarme" will recommend an MRI before the start of treatment to check the absence of meningioma. If it is nourished by the doses injected by the treatment, it grows, again and again. 

A reminder of patients, identified thanks to health insurance data, is also provided. This is the same, extremely rare procedure, initiated in the case of the Mediator and the Expakine antiepileptic. A letter should then be sent by the end of June to the women treated in the last 24 months.

And the others? The drug agency believes that, as "in many cases, meningiomas linked to the taking of cyproterone acetate can regress when you stop treatment" , it simply recommends "women treated in the past to discuss it with their doctor" , without "making brain imaging in the absence of a clinical sign" . It recalls the implementation of a green number ^[9] .

For those under Androcur or one of her generics, she advises an MRI "no later than five years later" the start of treatment. AMAVEA would have wanted more frequent control depending on clinical signs, due to the speed of development of certain tumors.

Emilie's tumor was already the size of a mandarin after only a month of Androcur. Even if it is impossible to know if she was already present in her brain before.

In any case, she was barely 9 years old. The endocrinologist - hormone expert - prescribed it for "early puberty", in order to "slow down the arrival of the rules" . As a result, "After the operation, I became a baby again, I could no longer speak or walk," says the 18 -year -old girl now, who has become epileptic.

As incredible as it may seem, the drug agency also had to recall that this treatment was not recommended in children.

***

^[1] The Minister of Health has also been arrested by the deputy Michèle de Vaucouleurs (democratic and related movement), herself alerted by the victims. But his question to the government remained unanswered at the time of publication.

^[2] Her first name has been changed, this dentist fearing that her patients will recognize her and doubt her visual acuity.

^[3] “Cases of (multiple) meningiomas have been reported in the event of prolonged use (several years) of Androcur in doses of 25 mg per day and more. »»

^[4] Froelich S. et al. , " Does Cyproterone Acetate Promote Multiple Meningiomas? » , Endocrine abstracts. Proceedings of the 10th European Congress of Endocrinology, Berlin, 2008.

^[5] Out of approximately five years of treatment at 50 mg per day (dose generally prescribed in the event of major hirsutism) or ten years of treatment at 25 mg per day, which corresponds to half cachets.

^[6] GAZZERI R. et al ., "Growth of a meningioma in a transsexual patient after Estrogen-Progestin Therapy", The New England Journal of Medicine , 2007.

^[7] 39 years after entering the shelves of pharmacies, Androcur still represents a quarter of cyproterone acetate sales, the generics, who arrived from 1996, sharing the rest of the cake.

^[8] Except that as the Levothyrox crisis - this medication taken by 5 % of the French population for thyroid problems - has shown it, Ansm letters and emails are often lost in the excessively watered mailboxes of white blouses. The Ministry of Health has proposed a report "on improving information for users and health professionals on the drug" . He is full of constructive proposals, as the fact of appointing a gentleman or madam having "the role of communicating in the event of a crisis" , but seems to have been relegated to oblivion.

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