Hair plated behind and alert gaze, Irene Frachon takes the hundred steps in the corridors of the Paris Court of Appeal. The Brest pulmonologist who was one of the first to denounce the Mediator scandal is about to testify at the helm. “The Servier laboratories did not accept the first decision which sentenced them to a fine of 2.7 million euros for aggravated deception . A day of turnover against 2,000 dead and tens of thousands of broken lives, it is still inexpensive, "said the whistleblower.

>> Our service - save money by testing our health insurance comparator

For thirty years, the French group has, in fact, managed to hide the amphetamine nature of this alleged antidiabetic often prescribed to overweight people. Result? While losing weight, the Mediator destroyed the heart valves of a large number of patients, even young and perfect health. "The more evidence of evidence on the toxicity of the Mediator, the more the experts of the Afssaps (National Agency for the Safety of Medicines and Health Products) swept our documents by taking up the language elements of the laboratory. Servier had accomplices in the place, it was demonstrated in court, ”insists Irène Frachon.

In 2011, the stubbornness of the pulmonologist pays. To calm the media excitement that each of his interventions arouses, Xavier Bertrand, then Minister of Health, is a clean sweep. It dissolves Afssaps and created the ANSM (National Agency for the Safety of Medicines and Health Products). New direction, new organization, a key word: transparency. Exit manufacturers from the agency's headquarters. Dragling decisions of drugs will take place without them. The all-glass and steel building located in Saint-Denis, in the Paris suburbs, will now welcome only healthcare professionals who are not suspected of conflicts of interest while involving patients in decision-making. Very nice promises ...

Read also Mediator: Servier laboratories return to court for six months of audience

A very high increase in hospitalizations due to the side effects of drugs

This morning in April 2017, on the train that leads her to Paris, the Briochine Isabelle Ellis Piaffe of impatience. She has an appointment at the ANSM. She will finally be able to talk about the hell she lives because of the Wife contraceptive implant marketed by the Bayer laboratories: seven years in wheelchair, pulmonary problems, pain that prevents her from taking care of her children. She hopes that her word will allow marketing to be prohibited. "All of the meeting consisted in eluding the real question: is this implant dangerous for our health?" Doctor Olivier Graesslin made a favorable presentation of the Essure by omitting to talk about patients who had already had to have the device withdrawn at the risk of their lives. ”

Four years later, when the first official figures fall, there are more than 30,000 victims including 51 deaths! Between 2014 and 2019, Doctor Graesslin received more than 30,000 euros from the Bayer laboratory for various clinical trials and still sits on the ANSM committee on Essure implants. What question.

Read also drugs: is a new Mediator scandal possible? If manufacturers officially no longer have a city right to the agency, their shadows hover everywhere in the cozy corridors of the Saint-Denis building. A former member always bound by confidentiality denounces this collusion: "The ANSM may have been cleaning internally but, as part of the expertise missions, it has an difficulty in recruiting doctors or teachers who are not in contact with manufacturers."

And for good reason: while France has 226,000 practitioners, the Euros for Docs database lists 19.7 million interest links over the 2012-2021 period. "The influence of laboratories on the whole world of health is immense," explains Frédéric Pierru, sociologist at the CNRS, specialist in health issues. In less than ten years, in France, the Big Pharma spent 8.6 billion euros in conferences, symposiums, conventions, clinical trials and others ... Enough to weave a canvas in the mesh as tight as it is invisible. With an annual operating budget of 130 million euros, the ANSM cannot fight. ”

Immersed in the heart of a system that seeks to cut on the impartiality of its members, the ANSM brandishes, despite everything, the independence card. It claims to "ensure the safety of health products" and "act in the service of patients". "It is going a little quickly to work," says Christophe Lèguevaques, a lawyer of 3,000 victims. In the Levothyrox case, when the first complaints appeared after the change of formula, the agency made its back. She did not sanction Merck who had not indicated anything on the medication box. She preferred to believe the industrialist rather than the thousands of patients who showed their troubles. This connivance can be explained because so -called independent experts, even members of the agency, had been paid by Merck a few years ago. ” The Merck laboratory, for its part, "reaffirms its confidence in the quality of its medication (...)". As for the ANSM, she did not wish to answer our questions, sending us back to her site.

ANSM and industrialists, an unscientific proximity

This porosity of the links between the agency and the industrialists is also maintained by the multiple exchanges between the two parties. In France alone, at least 450 medical congresses are organized each year, to which the ANSM experts can assist. But meetings can also be more informal, as during the Cham, in Chamonix, described as "health of health", or more modestly at the Giens workshops. These pharmacology seminars take place every summer on the discreet eponymous peninsula and bring together the medical, pharmaceutical world and ... ANSM. "I was invited once," explains the epidemiologist Catherine Hill. It was a promiscuity that I had found quite bad taste. Participants do not go there for scientific debates but to network. ”

In the United States, the limits are made much more clearly. The FDA (Food and Drug Administration, the equivalent of the ANSM) remunerates its experts sufficiently well so that the latter undertake to have no interest with manufacturers. "During international conferences, FDA members come out of the sandwiches of their bags so as not to have to eat the grandson of the labs!", Underlines Catherine Hill.

What is certain is that the hospitalizations relating to undesirable effects generated by drugs soar . A study conducted in 2018 by the 31 regional pharmacovigilance centers had thus identified 212,500 cases, an increase of 47% compared to 2007. As for the number of deaths, it would oscillate between 10,000 and 18,000 depending on the years!

"There is a hole in the racket in terms of risk management, and no doubt it only widens," emphasizes Dominique Dupagne, doctor. For the past ten years, the ANSM has not been responsible for putting medication on the market. Everything is played at European level. The ANSM is nevertheless responsible for their surveillance in France. Result: a lesser mastery of subjects and therefore more difficulty reacting when an alert appears. ”

Very worrying substances continue to flood the market

And there is no shortage of alerts. The independent journal "prescribing"-funded by its subscribers and without a link of interests with pharmaceutical laboratories-publishes the assessment of drugs more dangerous than used since 2013 each year. "Clinical data transmitted to drug agencies by firms are focused on efficiency, much less on undesirable effects, underlines Séverine Carré-Pétraud, expert for the magazine.

To "prescribe", we note that too often, when a doubt appears, it benefits the firm and not from patient safety. " The independent journal thus sounds the alarm on certain very worrying substances ... in vain. They continue to flood the market. Some are even available without prescription in the pharmacies! “This is the case of pseudoephedrine. This nasal decongestant found in many specialties-Humex Rhume, Nurofen Rhume, Dolirhume Paracetamol and Pseudoephedrine ...-is dangerous because of its serious cardiovascular adverse effects, "continues Séverine Carré-Pétraud.

Read also drugs: the Biogaran laboratory and a cardiologist sentenced to the death of a patient, this slowness of the ANSM to make decisions and inform patients is precisely at the heart of the Depakine scandal. As early as 1984, scientific studies show that the antiepileptic of Sanofi laboratories increased the risk of giving birth to children with autistic disorders. “Despite the evidence that has accumulated over the years, it was not until 2014 that the agency decided to launch an effective alert on the risk of serious development disorders (up to 30 to 40% of cases) and/or congenital malformations. Today, 30,000 families are victims of his negligence, ”said Charles-Joseph Oudin, a lawyer for many victims.

The ANSM indictments for "injuries and involuntary homicides by negligence"

In the case of Androcur and other progestins (drugs used in particular to treat endometriosis or even fibroids), the scientific community knew the risks of developing meningiomas - meninges tumors - at least since 2004, but it was not until 2018 that ANSM has published an alert allowing adequate information of patients and doctors! "We are millions to have taken this medication in complete innocence," explains Emmanuelle Huet-Mignaton, president of the AMAVea association (information, help and support for victims of Méningiomes). In my case, it was to treat endometriosis. I developed five meningiomas, one of 6 centimeters. Before my brain operation, I had lost the use of my right hand, I was aphasic. People have become hemiplegic. The most terrible is that some gynecologists who sit in the ANSM follow -up committees are sometimes still in denial and think that we can continue to prescribe this medication without informing the risk. "

Today, many scientists also point to the agency's failures in terms of pharmacological data analysis. “There is a break in expertise, a diplomatic tackle a recognized researcher from the scientific community. Difficult to say if it is linked to a recruitment of too junior profiles for lack of budget or a deficit in continuing education, a guarantee of internal skills. But it has inevitably led and lead to disasters. ”

Levothyrox Nouvelle Formula: an inadequate preliminary study

In 2017, the ANSM gave the green light to the marketing of the new Levothyrox formula. But, in a few weeks, she finds herself overwhelmed by a tidal wave of complaints. She has not seen that the preliminary study of Merck laboratories was inadequate. The latter was based on a comparison of the rate of medium thyroid hormones between the old and the new formula. "This" average comparison "is perhaps what the European authorities recommend, but, for a drug with such a narrow therapeutic margin, it was necessary to attach to the variation between the two formulations for each individual," underlines the epidemiologist Catherine Hill.

If this problem of major methodology has not jumped in the eyes of the ANSM, he nevertheless aroused the suspicions of Pierre-Louis Toutain and Didier Concordet, respectively pharmacologist and statistician at the Toulouse veterinary school. In 2018, they resume the data of the study made public on the ANSM site and provely demonstrate that individual variations make Yoyo in more than 60% of the 200 volunteers on the test! “ANSM's breaches are serious. Until this study falls, tens of thousands of people did not know what to connect their symptoms: intense fatigue, insomnia, nausea, depression, falls, suicidal desires ... The worst is that some of our interlocutors at the agency persist not to believe us and clearly position themselves on the side of Merck ", explains Beate Bartès, president of the association.

Between the ANSM and numerous victims associations, relationships have logically become ... freezing. In February 2017, after many reports, the ANSM charged a scientist from the Mines School to study Essure implants. Its report, rendered in April of the same year, is overwhelming and points to the dangerous degradation of the metallic springs inserted in the body of women. A month later, when a committee is held which aims to determine the risk-risk balance of the system, the document has disappeared from radars. Questioned by capital, the author of this report reveals: “I was surprised that no one is talking about it, especially in my knowledge there is no implant as dangerous for the organization on the market. But the ANSM had made me sign an agreement forbidden me to transmit the results for ten years. ” The victims who had access to this “ghost” document in 2022 thanks to a leak on the SPLANN site! (Breton NGO of journalistic investigations) did not take off. "It is a betrayal: if we had known such toxicity, we would not have spent so much time in medical wandering," explains Brigitte Marty Molino, president of Victim-Dmi, who brings together victims of the Essure and other medical devices.

The Ansm assigned to justice

In recent years, many cases have been settled before the courts. In 2020, the agency was indicted for "negligence injuries and homicides" in the Désakine case and in 2022 for "deception" in that of Levothyrox . She was also assigned to court by victims of Essure implants, perineal strips and Androcur. In June 2022, an association of patients victims of 5-FU also assigned the ANSM, accusing him of not having surveillance on the toxicity of the anticancer product for a period which she estimates at seventeen.

Finally, more recently, associations of patients who are victims of fluoroquinolones have filed a complaint against X, hoping for the indictment of the institution and all of the health authorities. These antibiotics prescribed in the case of bacterial infections can cause musculoskeletal disorders, neuropathies, aneurysms ... "For many victims, the contract of confidence is broken," explains Sabine Hahner, vice-president of the Victim-Dmi association. The Mediator may have been there, we continue to go from crisis to crisis without anything changing. ”

When the ANSM is assigned to the court ... It is the incriminated laboratory that produces parts in response to help it. "Justice considers that if the ANSM is attacked, the industrialist is too," explains Stephen Duval, lawyer for drug victims and medical devices in Lyon. To drown the judges and instill doubt, the laboratories emit thousands of documents. “To respond to this production, it would take 10 lawyers to work for years. And 80% of documents are studies without any scientific interest. It is still necessary to read them, analyze them ... Tobacco, oil manufacturers and more recently pesticides were the first to use this technique. ”

Read also Scandal of Désakine: Sanofi condemned for lack of information on the notice against the Big Pharms, the victims are small players. The ANSM too. "The agency is a fuse on which everyone comes to type," says sociologist Frédéric Pierru. In reality, cases that incriminate a laboratory go back to Matignon, even to the Elysée. It is at this level that a possible sanction is played out. And it is rare. The blackmail is implicit… ”

Should the institution go through a new organization to protect itself from the grip of industrialists? "It may seem counterbidden, but the ANSM would have every interest in surrounding himself with a high-level senior expert college having worked for labs. They are sophisticated and infiltrated the working methods of the interior, offers Dominique Dupagne. But it would be necessary, like the FDA in the United States, to pay them very comfortably and, in return, definitively prohibit them from collaborating with industry. ” The price to pay to avoid yet another scandal?

When the National Medicines Agency ousts whistleblowers

Mother of a child born with severe autistic disorders because of Dépakine, an antiepileptic that she took during her pregnancy, Marine Martin managed to impose, in 2017, two "pregnant woman" logos on drugs which have a teratogenic or fetotoxic character. One indicates that the product is not recommended to them, the other that it is prohibited to them. Warnings concerning 60% of the pharmacopoeia. "I learned on December 6, during an impromptu meeting at the ANSM (National Agency for the Safety of Medicines and Health Products), that these logos are called into question and that I will not have the right to participate in the debates," said the whistleblower. The ANSM has, in fact, preferred to call on other associations, including François Aupetit and Renalo, largely funded by industrialists.

Over the past ten years, each of them has received more than 800,000 euros. "We are transparent: the contributions of laboratories constitute 20% of our budget," explains Anne Buisson, president of the François Aupetit association. We have set up a charter that guarantees our independence. These sums help us to carry out projects for patients and make Crohn's disease known. ” Certainly, but by operating this choice, the ANSM contravenes its own regulation. An internal recommendation dating from 2017 indicates that "the financing of an association by a pharmaceutical laboratory for a sum greater than or equal to 10,000 euros (in the previous two years) risks placing the representative in a conflict of interest." On February 10, 2023, Marine Martin filed an appeal to annulment before the Administrative Court of Montreuil.

An unreliable accreditation system

If the marketing of medicines is the national drug safety agency or the European Medicines Agency, requiring a plethora of studies, that of medical devices depends on notified organizations. These service providers grant the precious sesame after examining a file established by the manufacturer and remuneration of up to 300,000 euros. In 2014, after sending a file full of errors and approximations, a Dutch journalist had thus succeeded in obtaining an agreement in principle to put on the market a device avoiding prolapse (descent of the organs based on the pelvic floor) which was, in reality, a ... Mandarin net!