A look back at 2009: one step forward, two steps back.

In 2009, we examined 104 new brand name products or new indications for existing products in the French edition of Prescrire. Only 3 of these 104 "innovations" provided some therapeutic advantage, while 19 had clearly unfavourable risk-benefit balances. Marketing authorisations are failing to adequately protect patients. A number of cheaper generic versions of useful drugs were introduced to the market, while BigPharma's anticompetitive practices were aimed at slowing the growth of generics manufacturers. The quality of over-the-counter drugs marketed for self-medication, especially "umbrella" brands, left much to be desired. Consumer protection is clearly not the primary concern of the European (EMA) and French (Afssaps) drug regulatory agencies. They remain too financially dependent on drug companies; hesitate to withdraw dangerous drugs from the market; and withhold drug safety data. Other signs of drug companies' excessive influence, at patients' expense, include drug pricing that bears little relation to therapeutic advantage (in oncology, for example); the financial dependence of many patient groups on drug companies; the European Commission's attempts to authorise direct-to-consumer advertising and to allow the pharmaceutical sector to tighten its grip on health information, including pharmacovigilance data. Governments must assume their responsibilities, and patients and the healthcare profession must resist BigPharma's increasing involvement in all spheres of patient care.