The director of the National Agency for the Safety of Medicines and Health Products (ANSM), Christelle Ratignier-Carbonneil, was elected vice-president of the board of directors of the European Medicines Agency (EMA), this Monday 20 June. An international promotion that is debating, since it comes after a few tumultuous years.
After the ANSM, head for the EMA
A press release from the ANSM, published on June 20, announces that Dr Christelle Ratignier-Carbonneil will chair the EMA for three years, alongside Lorraine Nolan, president of the board of directors.
In December 2020, just appointed director of the ANSM, Christelle Ratignier-Carbonneil declared: “I will strive at all times to ensure that the ANSM is an agency that listens to all users, to all their expectations. […] An agency within which, in all of its activities, each decision, each action, is guided by a safety objective for patients exposed to the health product”.
Throughout her mandate, the words of the former director of the National Agency have been highly commented on. Regarding menstrual disorders related to vaccination, for example, she said in December 2021: “We’ve had a few hundred reports of menstrual disorders, both with Pfizer and Moderna.”. But according to her, these were mostly just “short duration””.
As a result of injections, many women today experience menstrual pain, abnormal bleeding… Some even have to consider life-altering decisions, such as hysterectomy, i.e. removal of the uterus.
Read also: “They no longer have periods” after the covid vaccine: “Where is my cycle” frees women to speak about side effects
ANSM and successive crises
Succeeding Dominique Martin, the former director general of the ANSM then appointed national medical adviser to the National Health Insurance Fund (Cnam), the mandate of Christelle Ratignier-Carbonneil was tumultuous.
As a reminder, the ANSM was born with the trial of guitar pick. This health and legal case presented a danger for the people who were victims of the benfluorexmarketed under the name of Pick by Servier laboratories from 1976 to 2009. This antidiabetic drug and for people with high cholesterol is responsible for the death of almost 500 to 2,000 people. In the trial delivered on Monday March 29, 2021, the court sentenced the Servier laboratory to a fine of 2.7 million euros for “aggravated deception”.
For its part, the ANSM was ordered to pay a fine of 303,000 euros, since it was slow to suspend the marketing of the product. The criminal court ruled that the agency “failed in (its) role of health police and drug policeman”.
The Levothyrox Affair, a thyroid drug, was later the subject of another health scandal. The Merck laboratory was definitively ordered to pay 1,000 euros to the 33,329 patients who filed a complaint for “lack of information”. Between 2017 and 2018, patients treated with the new formula of the drug Levothyrox suffered serious side effects. In 2019, they unanimously decide to file a complaint against the German pharmaceutical company Merck.
What about ANSM’s role at that time? Legitimately, some patients wonder about the modification of the formula. However, the ANSM considers that the change in composition is “final”, despite an online petition having gathered nearly 40,000 signatures to demand a return to the old formula. And in 2018, when the ANSM confirmed the presence of heavy metals in the new formula, although it had previously assured that there was no risk. Once again, the authority denies the facts. According to her, “information questioning the quality of the new Levothyrox formula is unfounded.” The ANSM ensures that “It does not represent a health risk”.
According to Les Echos, a collective legal action has been launched against the drug agency (ANSM) in the Levothyrox case, by a lawyer who hopes to obtain 15,000 euros per plaintiff.
And again in November 2020, when the ANSM was indicted for “negligent injury and manslaughter”. This is theDepakine affairan anti-epileptic, causing birth defects.
In short, public health scandals are not new. However, some are alarmed about the disputed role of the ANSM. According to Philippe Courtois, Bordeaux lawyer, “for health scandals, the ANSM is an alarm that never rings”. Me Courtois questions the role of “doctors, laboratories and control bodies”. And ventures to think that it is always the victims who alert, little taken seriously and mistreated by the health authorities.
On the other hand, the lawyer reports that the ANSM is financed at 80% by the taxes paid by the laboratories, in particular “that deducted for the marketing authorization of a product”.
EMA absent from OPESCT hearing on adverse effects linked to vaccination
Regarding the side effects reported following the anti-covid vaccination, the former director of the Medicines Agency assured that after a week of vaccination, “no serious adverse effects have been reported in people who have been vaccinated”. However, the victims petitioned the Senate. This was more or less heard, since a public hearing organized by the Parliamentary Office for the Evaluation of Scientific and Technological Choices (OPESCT) took place on 24 May.
Read also: Amine Umlil will be heard in the Senate on May 24 on the adverse effects of the anti-Covid vaccine
If on the one hand, the EMA controls medicines, thus allowing their marketing authorization in the European Union, on the other hand, the ANSM guarantees the safety of medicines and health products in France. Given the international nature of the health crisis and the cooperative side of its management, some wondered about the absence of the EMA during the hearing of the OPECST. Often, the ANSM evaded the questions there by referring to the absentee. And the absent are always wrong?
Cédric Villani concludes by noting that the EMA (European Medicines Agency) should have been present, that he would have requested it in writing – it was a bit like the elephant in the room (or rather absent…) because the ‘ANSM regularly returned to Europe…
– FranceSoir (@france_soir) May 24, 2022
For the rest, Christelle Ratignier-Carbonneil seems confident. She declares to be “firmly convinced that close collaboration and a partnership approach between national agencies such as the ANSM and the EMA are essential to face current challenges and prepare for the next ten years to come”. The Vice-President adds that she wants “accelerating innovation while increasing security for all European citizens”. It thus seems to be part of the group of those who predict new health events, alongside the WHO and Bill Gates, among others.
Read also: WHO Treaty on the prevention of pandemics: Polish researchers sound the alert
This recent change of position for Christelle Ratignier-Carbonneil remains little commented on. However, some hope for a change of direction from the EMA, but above all for an assumption of responsibility, particularly in terms of the side effects of vaccination.
The EMA Board of Directors elects Christelle Ratignier-Carbonneil, Director General of the@ANSM as vice president. We hope that she will be able to work to open security signals raised by the CRPVs.https://t.co/fymyyaavhT
— Christine Cotton (@ChrisCottonStat) June 21, 2022