Prescribed since the 1980s as part of the treatment of hyperpilosity in women, or to mitigate the effects of prostate cancer in men, Androcur had been the subject of serious accusations since 2009.
At excessively high doses (>25mg), this progesterone derivative is indeed suspected of promoting the risk of developing a meningioma, a benign form of brain tumor.
During 2018, the health authorities are therefore launching a campaign in two stages.
They warn doctors of the high risk of meningioma and ask them to perform brain examinations on a large number of patients taking Androcur.
The following year, they sent a letter to all those who had recently taken this treatment.
A report published on December 1 and written by the scientific interest group EPI-PHARE, a public expertise structure in epidemiology resulting from the collaboration between the National Agency for the Safety of Medicines (ANSM) and the National Fund for Health Insurance (Cnam), shows the spectacular results of these measures.
Before 2018, around 100 women were operated on each year because of Androcur-related tumors.
In 2021, they were less than ten.
"
The number of operated meningiomas was reduced by 93% in 2021 compared to 2017, a considerable drop which reflects the success of the actions carried out by the health authorities
", analyzes Alain Weill, deputy director of EPI-PHARE.
With the establishment of a toll-free number and the sending of nearly 120,000 letters, this is the third time that such important measures have been used after the pick and depakine affair
, "said Alain Weill.
If Androcur is still available in France, the EPI-PHARE study also looked at existing alternatives.
The ANSM estimates that just over 5,000 women are currently taking Androcur or one of its generics, ten times less than at the beginning of 2018. "
For women, having stopped after August 2018, 34.9% reported another sex hormone.
At first, it was feared that people would turn to other acetates, nomegestrol and chlormadinone acetate, which are also at risk for tumors.
However, we found that this was the case for only 5% of individuals
”, specifies Alain Weill.
Most simply stopped taking treatment.
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“Ten years late”
Why did you wait so long before taking such measures?
While meningiomas are unlikely to develop into fatal cancer, they can cause severe disabilities, such as visual or motor disabilities.
“
I have definitely lost my sense of smell
”, testified for example recently to AFP Anne Le Beuz, 50, whose olfactory abilities did not survive the removal of a meningioma in 2019. She had taken 'Androcur for six years, as a contraceptive pill and as an anti-acne treatment when these indications are not officially provided for this anti-androgen molecule.
But in fact, and particularly in France, doctors have prescribed Androcur for several decades well beyond its indications.
It was a study published in 2018 that was decisive in the choice of health authorities.
If they had already imposed on Bayer to mention the risk of meningioma in the leaflets of the drug since the beginning of the 2010s, no other measure had been taken.
But the 2018 study shows that the risk of meningioma was multiplied by seven in patients on Androcur for more than six months, and by twenty beyond five years.
Without this study, "
we would not have had the necessary hindsight, we would not have shown or found everything that we have highlighted
", argued in early December, during a press conference, Isabelle Yoldjian, medical director of the ANSM.
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The argument does not convince the patient associations and their lawyers, who, without absolving Bayer, tend first to refer the responsibility to the health authorities.
The ANSM “
acted ten years late, at least
”, judged the lawyer Charles Joseph-Oudin, who accompanies around twenty patients in legal proceedings, in particular alongside an association, Amavea.
"
Doctors had to be informed, in a targeted manner, of the existence of a risk as soon as a signal emerged
", according to him.
What should be remembered: the effectiveness of the actions or their too late nature?
The case of Mrs. Le Beuz, whose meningioma was diagnosed following the letter from the ANSM in 2019, is a perfect illustration of the question.
“
I am grateful to have been informed because, otherwise, more serious symptoms would have alerted me
,” she explained.
But there is also “
the anger of the lack of information, both at the laboratory level and at the ANSM.
I say to myself: We could have stopped before, it could not have happened to me
, ”she added, judging that the medical profession also bore a large part of the responsibility.