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France and its drug agency have they learned the lessons of the health scandal?

During the seven-month hearing, she kept a low profile. At least those who represent it. TheNational Medicines Safety Agency (ANSM), judged alongside the Servier laboratories in the Mediator case, will be fixed on its fate, Monday, March 29. The Paris Criminal Court, which delivers its judgment at the end of a long trial, will he follow the requisitions of the prosecution? A fine of 200,000 euros was demanded against the ANSM for delay in suspending the marketing ofe this anti-diabetic, used as an appetite suppressant and responsible for several hundred deaths in France. Through the voice of its former director, Dominique Martin, the agency made it known that it was not asking for the release and recognized to “share of responsibility” in this “drama”, one of the worst French health scandals.

In reality, the ANSM did not exist in 2009, when the Mediator affair broke. The regulator is then called Afssaps (French agency for the safety of health products). He has been informed since 1995 of the dangerousness of benfluorex, the molecule marketed under the name Mediator, known for its anorectic properties. The first serious cases of heart disease reported in 1999 did nothing: the drug retains its marketing authorization (MA) for ten years. Paid as consultants by the Servier group, certain experts sit in parallel on agency commissions, ruling in particular on the Mediator. We will have to wait for Irène Frachon’s alerts, pulmonologist at Brest hospital, for the drug to be withdrawn from sale.

It was Xavier Bertrand, just appointed Minister of Health, who inherited this file at the time. To put an end to these misguided relations between the drug gendarme and the laboratories, he had a law passed in 2011. Exit the Afssaps, place at the ANSM, with a new management and an organization protected from conflicts of interest. Manufacturers are excluded from the board of directors and the commission in charge of marketing authorizations. Instead, patients and parliamentarians make their entrance. Funding has been revised: the agency’s budget is no longer based on taxes paid by laboratories but on a State subsidy. Health professionals and pharmaceutical companies are now obliged to declare their competing interests on udo public database. On the pharmacovigilance side, patients can report side effects themselves on a platform, since 2017.

Were these measures sufficient to guard against the abuses of the Servier era, whose powerful boss, Jacques, died in 2014? On the issue of conflicts of interest and transparency, opinions are divided. Not only is the database self-reporting, but “There are a lot of consulting firms that can act as front companies between an expert (…) and the lab. These are convenient ways of evading reporting.”, explains on franceinfo Bernard Bégaud, professor of pharmacology at the University of Bordeaux.

On the contrary, the former Minister of Health Marisol Touraine points to an excess of zeal: “After a period marked by absolute tolerance, the pendulum sets off a little too far in the other direction. The law requires transparency but does not prohibit links of interest. The important thing is to know where are talking about. these experts. ” For the former socialist deputy Jean-Marie Le Guen, former president of the hospitals of Paris, this “health policy, traumatized by the Mediator affair, is costing us dearly in the end”.

“This endogamic culture between the drug industry and health authorities deserved to be reformed. But the spirit of the precautionary principle can lead to powerlessness in research.”

Jean-Marie Le Guen, former PS deputy

to franceinfo

However, these precautions did not prevent the occurrence of other health scandals in France. Dépakine, PIP prostheses, Pandemrix vaccine against H1N1, anti-acne Diane 35, Androcur, Levothyrox… If these cases go beyond the borders of France for some, they reveal shortcomings specific to the French system. In a 2013 report, epidemiologist Dominique Costagliola and pharmacologist Bernard Bégaud pointed to a “more massive misuse than elsewhere” drugs, often prescribed for a use other than that provided for in the Marketing Authorization, and a “lack of precise data” to assess the risks.

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On this last point, the situation has changed. “Since the Mediator affair, France has made great progress in pharmaco-epidemiology [l’évaluation du bénéfice-risque d’un médicament en population réelle] because health insurance data has been made accessible and usable “ for the ANSM, explains Bruno Toussaint, editorial director of the journal Prescribe. This database of nearly 67 million policyholders is one of the largest in the world. A gold mine that is still under-exploited for lack of human and material resources.

Have we learned the lessons in terms of pharmacovigilance? “Absolutely not”, shouts Catherine Hill, member of the scientific council of Afssaps at the time of the Mediator. The reports which go back via the caregivers and the patients are certainly easier and more numerous, but, according to the epidemiologist, their treatment relies too much on the “principle of accountability”, that is, looking for a known cause and effect link between the drug and an observed symptom. If this link is not already established in the scientific literature, it is discarded for the benefit of the doubt. A doubt which, in this case, always benefits the drug. “With the current system, we dezinge the lifts. The proof, we continue to have a whole lot of pissing off”, she castigates.

Bruno Toussaint, from the review Prescribe, presses: “There is still too much influence, weight, pressure from pharmaceutical companies on the state of mind of the drug agency.” And to cite the example of Levothyrox, this treatment for the thyroid whose formula was modified in 2017 by the German laboratory Merck. “LThe agency trusted the firm’s good record too much and quickly assured that there would be no problem, he notes. In Belgium, the health authorities warned patients, no one was surprised and there was no scandal. “

In the case of the clinical trial of Biotrial in Rennes, which died in 2016, Mediapart and Le Figaro also revealed “l’indulgence” of the ANSM with regard to the laboratory and then its attempts to clear customs. The agency’s relations with the press, sometimes described asenemy “ or “friend” internally, are sometimes stormy. Asked several times by franceinfo, the ANSM communication service did not respond. A mistrust linked, for some, to its primary mission: to act as an airbag between the top of the State and health scandals. “It is not an independent authority, it is under the supervision of the general directorate of health”, advance the former PS deputy Gérard Bapt, president of the parliamentary information mission on the Mediator in 2011.

“When we tackle the administration, it becomes one. You need people of the caliber of Irene Frachon to shake up the coconut palm.”

Gérard Bapt, president of the parliamentary mission on the Mediator in 2011

to franceinfo

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During the trial, which she followed in full, the whistleblower observed an ANSM “Completely subordinate to Jacques Servier. It is a formidably effective pharmaco-delinquency act which has neutralized the agency”, testifies the pulmonologist, who hopes for a severe judgment for “white collar crime in the health sector”. Regarding the scandals that followed, Irène Frachon regrets “dramatic cases for the victims” dont “It is difficult to identify those responsible, because it is more of an indifference to risk”, she emphasizes, calling for a review of the 2011 law.

For some observers, the prerogatives of the ANSM remain limited anyway. The Dépakine affair is a case in point: although it ended up banning in 2018 – ten years after the first alerts – the prescription of this antiepileptic for patients of childbearing age, 314 pregnant women were still exposed to it. valproic acid in 2019 (compared to 332 in 2018 and 412 in 2017), according to information from franceinfo. In a report on the ANSM published at the end of 2019, the Court of Auditors thus invited “closer collaborative work in the field of prescribing practices, in particular with health insurance and the Haute Autorité de santé”. “There is a will to move forward but the boat is quite heavy. The whole system has to be changed”, observes Gérard Raymond, president of France Assos Santé, which represents patients.

Another considerable obstacle: Europe. Since 1985, MAs have been issued by the European Medicines Agency (EMA). “The ANSM does not have total sovereignty. If the EMA says that a drug can be authorized, the ANSM cannot ban it”, recalls Jean-David Zeitoun, doctor and drug specialist. Annie-Pierre Jonville-Béra, president of the 31 regional pharmacovigilance centers (CRPV) which forward the signals to the ANSM, takes the example of the alert on the risk of bacterial infection favored by non-steroidal inflammatory drugs in the Ibuprofen type: “The agency followed us but at European level, it flopped. They changed four lines on the notice.”

For the pharmacologist, the only leeway for the ANSM is to communicate more about the risks and the proper use of drugs. Provided that the “cases are promptly documented”. Clearer, less administrative pharmacovigilance management, “simplified and transparent”, in the words of Gérard Raymond, for the benefit of those primarily concerned: the patients.

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