The new health scandal concerning the anticoagulant Pradaxa, who has already claimed several victims, did not fail to recall the Mediator affair, accused of having caused the death of more than 1,300 people and withdrawn from the sale since November 2009. “Three years later, undoubtedly, things are better. The National Agency Drug Safety Authority (Ansm) got rid of some unsavory experts and made a real effort to make its decisions transparent. are registered, the public can have access to a drug register on the online site. However, not everything is settled, far from it “, explains The Parisian in its edition Today in France October 10.
Indeed, according to the daily information, the Ansm would have been fooled in the Thiotà © pa affair, an outdated anticancer drug from the Alkopharm / Gà © nopharm laboratory. . “A big annoying bug for the agency” would be the cause of a publication error concerning this drug, withdrawn from the sale at the end of 2011. Another embarrassing matter: the false alarm of the Furosémide, the diuretic manufactured by the Teva laboratory, whose plant has been inspected several times for a hidden antidepressant, while it has been inspected several times. The error came from a patient.
The Parisian take advantage of the recent crises to recall the role of Ansm: to assess the health risks presented by drugs. “It gives the French access to drugs, by issuing marketing authorizations (AMM). It also monitors products, and communicates information on the drug to patients. drug safety “, explains its deputy general manager, François Hà © bert. External experts come to lend a hand to the thousand people who work within the Agency. “Doctors from pharmacovigilance networks in CHUs whose information on the side effects of drugs is reported. In fact, according to many sources, this report is insufficient and explains why dangerous drugs stay too long on the market, “adds the daily.
Despite the changes caused by the Mediator case, other problems arise, as indicated to the Parisian Jean-François Bergmann, former vice-chairman of the AMM commission: “It is better at the level of ethics, but we are losing in terms of competence. By dint of wanting to exclude researchers who have links with the industry, we end up with volunteer retired doctors, sympathetic, but who do not always have the level needed to make such strategic decisions. ” Lâ ???? Ansm warned: there is still some work to be done.
