Deepening scandal

Unfortunately for Servier, most mention of its name at present is connected with Mediator. The drug was originally on the market as a diabetes treatment, but became widely used off label for weight loss (8). In 2009, it was revealed that the drug might be linked to 500 deaths in France, and media and public outcry led to its removal from the market (2). Astonishingly, Jacques Servier was quoted in the French media as saying that there had been no more than three deaths due to Mediator, which prompted an angry reaction from the Health Minister Xavier Bertrand (9).

The French regulator, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), was criticised for not acting on earlier information that structurally similar drugs could cause valvular heart disease and pulmonary arterial hypertension (8). Regulators in other European markets and the US had taken strong action over related agents and there is still anger as to why similar action was so slow to take place in France. The Mediator scandal has also had a dramatic effect on the regulatory mechanisms of the French healthcare system. In January 2011, the head of the French regulatory agency was forced to resign and the agency has since also been renamed the National Agency for the Safety of Medicines and Health Products (ANSM) (10).

Such revelations have led to an overhaul of the French system, and in December 2011, a law to reform how drugs are approved and regulated was adopted by the parliament (2). Under the new system, potential new drugs must be compared with existing approved therapies rather than just with placebos, if they are to be reimbursed under the public health insurance system. Furthermore, greater transparency is being insisted on, with pharmaceutical companies being forced to declare their links with outside organisations and individuals or face criminal sanctions for failure to comply (2). The new law is still in development, but has been criticised over certain aspects, such as an additional clause that states that a drug will be reviewed every five years regardless of problems. The French pharmaceutical industry body, les enterprises du medicament (LEEM), has also expressed concerns at clauses in the new law intended to restrict visits by sales representatives and ban company-funded medical education (12).

Patient groups have launched a number of legal cases against Servier and in December 2011, the Cour de Cassation, France's highest criminal and civil court of appeal, rejected a request from Servier, for all lawsuits being brought against the company to be consolidated into a single trial (13). This is a major setback for Servier as the cases are likely to drag on for several years. One of the first cases will be a trial before the correctional court of Nanterre, where Jacques Servier himself and several executives of the company will face charges of "deception", which they were charged with in September 2011 (13). Beyond this, the company's executives face more serious charges for "involuntary homicide and injuries" (13).

Public demand for someone senior to be held accountable is high and the authorities will be keen to be seen as dispensing justice. Jacques Servier risks a maximum prison sentence of four years and the company is likely to face huge claims for damages. The worst-case scenario could see the company lose its operating license.

Outlook

Servier's R&D successes this year will be pushed into the background as further details about Mediator emerge. The ongoing case also has wider ramifications because it may set a precedent for future cases involving drug safety issues. It is unusual for a company's top executives to be named and shamed, and the Servier case shows that in serious cases involving public health, senior people may find themselves on trial. Equally, regulators will be under greater scrutiny and are likely to become increasingly conservative because any oversight may come back to haunt them.

The pharmaceutical industry as a whole will also be concerned that the fallout from the Mediator case will cloud the public's views over what can be considered acceptable regarding the risk–benefit profile of products. The industry's interactions with regulators and healthcare professionals will also come under greater scrutiny. Servier has often publicly highlighted how it differs from other pharmaceutical companies in the way it operates its business, but the irony is that critics of the pharmaceutical industry will consider Servier's actions as typical of the sector. The Mediator case has already led to changes in the way that France approaches the regulation and promotion of medicines. Whatever emerges over the next year also has the potential to influence markets in other countries, which will be keen to safeguard against any flaws proven in the French system.