The aftermath of the Mediator° disaster and the serious regulatory shortcomings it revealed led the French authorities to make some improvements to their procedures and decisions in 2011 (Prescrire Int n° 121).

For example:

• The French drug regulatory agency finally made a real effort to be more transparent: the working sessions of the marketing authorisation committee are now described in detailed reports, albeit se­veral months later; some (but not all) discussions are now filmed and posted online; and the agendas of the marketing authorisation committee are now made public. Previously, reports of this committee’s activities were scant, and none of its debates was filmed for public viewing;
• the French agency triggered reassess­ment of several drugs at the European level, including pholcodine, pioglitazone (alone or combined with metformin), and trimetazidine;
• the French agency decided to withdraw several drugs with negative harm-benefit balances (see inset page 108);
• the French authorities are taking more notice of recommendations of the Transparency Committee (which assesses the medical benefits of new drugs and advises on drug reimbursement) to stop reimbursing several drugs rated as providing inadequate medical benefit to patients, some of which have been on the market for several years.

In contrast, the European authorities have yet to take action on these points:

• the opacity of pharmacovigilance data persists: for example, information was withheld on the risks of bladder cancer associated with pioglitazone (Prescrire Int n° 123);
• doubts regarding drug safety still continue to benefit drug company profitability rather than patients’ interests: some drugs were kept on the market despite their established harms, including dronedarone, nimesulide, pioglitazone, pholcodine and varenicline (see inset page 108);
• in the public consultation launched by the European Medicines Agency (EMA), posted online in late 2010, the Agency proposed to make head-to-head comparisons with a standard drug the exception in premarketing clinical trials, meaning that placebo-controlled trials would become the rule (Prescrire Int n° 121);
• the European Commission left signal detection and the interpretation of post-marketing surveillance data in the hands of drug companies. These are both key elements of drug safety (isdbweb.org);
• the European Commission continues to insist on removing barriers to direct-to-consumer advertising by drug companies for prescription-only drugs. Following the public outcry in late 2010, the Commission was forced to revise its proposals to allow direct-to-public advertising of prescription drugs, disguised as “information”. However, the amended proposals published in October 2011 still leave the door open to this type of advertising, particularly the proposed legalisation of reminder advertising (a) (english.prescrire.org).

The public must encourage authorities to focus more on patient safety, through actions such as those conducted by the patient group Amalyste (victims of Lyell and Stevens-Johnson syndrome) and Act Up (people living with HIV/AIDS) (click for details in French), and member associations of the Medicines in Europe Forum (b) .

Notes:
a- Reminder advertising  is a marketing practice which aims to familiarise the public with a brand name by using every opportunity to mention the name of the product, including using images of the brand and building an emotional connection with the brand.
b- Founded in March 2002, with more than 60 member organisations in 12 European Union member states, the Medicines in Europe Forum is composed of 4 major groups of healthcare stakeholders: patient groups, family and consumer organisations, health insurers, and healthcare professionals (learn more)

©Prescrire April 2011

"New drugs and new indications in 2011. France is better focused on patients' interests after the Mediator° scandal, but stagnation elsewhere" Prescrire Int 2012; 21 (126): 106-110. (pdf, free)