Is the safety of the French concerning the drug really ensured?

Doctissimo: Why write this book today?

Anne Jouan: After the judgment of the Paris Criminal Court concerning the Mediator case in March 2021, I called Professor Christian Riché. For 11 years at Le Figaro, he was one of my sources at the Medicines Agency since he was one of the experts there. I wanted to talk to him about the judgment that had just been handed down, namely the condemnation of Jacques Servier and the Medicines Agency.

At the end of our discussion on the telephone, I told him that the National Audiovisual Institute (INA) had asked me to write about my sources and that I was going to devote a chapter to it. To my surprise, he tells me that the time has come for him to speak and that he is ready to write a book.

What revelations did he share with you?

Christian Riché recounts the creation of the agency dating back to 1993 – since he was an expert from the 1980s with the Ministry of Health. This agency was created as a result of the tainted blood affair. He thus explains its creation, its constitution and especially its internal functioning. He explains in particular how an agency official came to see him to ask him to modify a European report for which he was an expert, in order to market a drug intended for intensive care. A drug for which it was known that there were unexplained deaths. He further explains how the chairman of the marketing authorization commission came to him to ask him to set up a group of experts to delay the banning of a toxic herbicide called Paraquat, which was accused of promoting deaths due to liver problems…

After the Mediator affair, everything had to change: the name of the agency changed, the boss of the agency changed… But in reality, very little changed. On the contrary, 5 sources from the agency say that today, it is worse than in 2009. They explain that it has lost in skills, in scientific quality (instead of recruiting Bac+7, we recruit bac +3), that there are translation problems, that there are requests to water down reports before making them public…

A director of the agency explains that this incompetence and this lack of political courage of the agency appeared in broad daylight at the time of the Didier Raoult affair. From the winter of 2020, we knew that strange things were happening at the IHU in Marseille and the agency should have ordered an inspection and went there to see what was really going on with the professor’s protocols. Raoult. But at the time, to go to IHU, you had to have the approval of the guardianship, that is to say the Minister of Health, or even higher up at the Elysée. By pure wait-and-see policy and political fear, the agency has therefore done nothing while it has the role of drug policeman. She has the power to knock on the door of an institute, a hospital to see how trials are going, ask for protocols, see patients… But in the end, for 14 months, the inaction of the The agency has put patients at risk by letting them take part in these problematic trials.

You point the finger at possible collusion between the health authorities and the drug industry. What do they consist of?

Thanks to the searches which were able to take place within the framework of the judicial investigation linked to the Mediator scandal, we have seen what was the nature of the contracts between the very important members of the agency (employees or external experts with the agency ) and the drug industry (in this case the Servier laboratory).

Finally, these links are incestuous and ancestral links, since Christian Riché says that at the beginning of the 80s, when he wanted to become an expert for the ministry, he was asked for a letter of recommendation, but not just any letter of recommendation: a letter from the pharmaceutical industry!

And these links still persist today since at the end of the book, a member of the agency tells us that to work on an expert report, the agency asked a woman who is a former employee of Servier, married to the former Chairman of the Marketing Authorization Commission… In the end, these collusions have never ceased.

What are the consequences of these collusions?

They are problematic on two levels.

• The first, the most obvious, is a direct consequence on the health of our fellow citizens. We saw it with the Mediator affair;
• The second is the rise of distrust vis-à-vis these institutions. The lack of transparency and the persistence of these links means that the general public no longer has confidence in these institutions that are supposed to protect it. We saw it at the time of vaccines against COVID or hydroxychloroquine. This mistrust is problematic because it endangers the long term.

What areas of improvement do you think are urgent?

You have to question a number of things. When an expert tells at the end of the book that last winter, the scientific director of the agency proposed – during a meeting by zoom – to go and pay homage to the father of homeopathy on his grave located at Father – Lachaise, it still raises questions.

When people in charge of pharmacovigilance tell you that they can’t reach anyone or that there are problems translating side effects or monographs, that’s not normal.

But within the drug agency, people are not all rotten, there are many, especially those who spoke to me, who are frightened, outraged by what is happening internally and who want things change.

And if we do not give a big kick in this anthill, the question arises: is the health security of the French concerning the drug really assured?