title: New drugs and indications in 2011. France is better focused on patients' interests after the Mediator scandal, but stagnation elsewhere.
abstract: Progress in the pharmaceutical sector accounted for only a tiny proportion of the hundred or so new products and indications analysed by Prescrire in 2011. About 1 in 6 new products had more harms than benefits, while more than half of all new products provided no advantages over existing options. One worrisome trend was the expansion of "umbrella" ranges for self-medication. As in previous years, drug regulatory agencies continued to grant marketing authorisation prematurely or on the basis of inadequate evaluation. This was especially true for paediatric medicines, despite some limited progress. In the wake of the Mediator disaster, the French health authorities in charge of patient protection, including the drug regulatory agency, finally reacted by withdrawing many old drugs with negative harm-benefit balances and made an effort to increase transparency and to provide better information on drug-related harms. European authorities showed no signs of similar improvements in early 2012. Drug companies continue to promote their products aggressively, which is not in patients' best interests. The medicalisation of life continues apace, with more and more direct-to-consumer advertising. The Mediator disaster was a wake-up call for French policy makers. In late 2011, several new regulations serving patients' interests were adopted, including greater transparency and better management of conflicts of interest, but as yet, with no major breakthrough in attitudes and procedures.
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D005602:France; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000592:standards; D056737:Safety-Based Drug Withdrawals / Q000331:legislation & jurisprudence
chemical_list: D004364:Pharmaceutical Preparations