A leading journal has expressed caution about the management of pharmaceutical policy being transferred from the European Commission’s Enterprise and Industry directorate to Health and Consumer Policy (DG SANCO) and criticised the latest pharmacovigilance proposals.
An editorial in the BMJ’s Drug and Therapeutics Bulletin says that the long-awaited switch, which involves responsibility for the European Medicines Agency, comes after the Enterprise and Industry directorate appeared “to have favoured drug companies’ profitability and competitiveness at the expense of public health”. The journal says this is illustrated by the EC’s pharmacovigilance proposals which, if accepted, “could allow inadequately evaluated medicines to reach the market early because of the increased emphasis on ‘risk management plans’ and post-authorisation studies, rather than evidence before licensing”.
The DTB argues that “this has already happened” with Sanofi-Aventis’ now-withdrawn anti-obesity drug Acomplia (rimonabant). In addition, all adverse reaction data will be reported by drug companies directly to a single point – the Eudravigilance database and data-processing network – “so bypassing expert pharmacovigilance centres in member states”.
The journal says the proposals would give companies a greater role in collecting safety data, “even though experience has shown that they can have a vested interest in delaying pharmacovigilance decisions”. It cites the example of compensation paid to thousands of plaintiffs who complained that data were withheld about metabolic adverse effects with Eli Lilly’s Zyprexa (olanzapine), which, it claims, “the relevant company had not been forthcoming about”.
The editorial goes on to state that “public health disasters” from thalidomide in the 1960s to the more recent “debacle” over Merck & Co’s withdrawn COX-2 inhibitor Vioxx (rofecoxib) emphasise “the crucial importance of independent and effective pharmacovigilance”. It concludes that the EC will have to demonstrate that the switch to DG-SANCO “is not cosmetic, but will give the EC a new approach to health and medicines, that of putting patients’ safety first”.
