OR WAIT null SECS
Nathan Jessop is a columnist for Pharmaceutical Technology Europe.
Whichever way you look at it, 2012 will be a dramatic year for Servier. The French company has a number of collaborations that could lead to a new generation of products, but any positive news from these developments is likely to be overshadowed by the ongoing safety scandal of its diabetes treatment Mediator (benfluorex hydrochloride).
Whichever way you look at it, 2012 will be a dramatic year for Servier. The French company has a number of collaborations that could lead to a new generation of products, but any positive news from these developments is likely to be overshadowed by the ongoing safety scandal of its diabetes treatment Mediator (benfluorex hydrochloride). A major court case is set for mid-year and the controversy continues to implicate an ever-growing list of prominent people in France.
Servier’s R&D successes notwithstanding, most mention of the company’s name is at present in connection with Mediator. The drug was originally on the market as a diabetes treatment, but became widely used off label for weight loss. 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.
The scandal also led to French regulator, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), being criticized for not acting on earlier information that structurally similar drugs could cause valvular heart disease and pulmonary arterial hypertension. Regulators in other European markets and in the US had taken strong action over related agents so there is anger as to why similar action was so slow to take place in France. Mediator 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).
Although acknowledging that safety regulators had missed a series of warning signs in previous years, the French government pointed the finger at Servier. But it has been difficult for the government to totally shift the blame after an interministerial commission revealed that voting members of the approval committee had been allowed to simultaneously serve as consultants or employees of the companies they were supposed to be regulating.
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. 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 pharma companies being forced to declare their links with outside organizations and individuals or face criminal sanctions for failure to comply. The new law is still in development, but has been criticized over certain aspects, such as an additional clause that states that a drug will be reviewed every five years regardless of problems.
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. This is a major setback for Servier as the cases are likely to drag on for several years. One of the first 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. Beyond this, the company’s executives face more serious charges for “involuntary homicide and injuries”.
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 - now approaching 90 years of age - 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.
The pharma industry as a whole will 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 pharma 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.
For the full version of this article, click here.