Holmes Report 29 Mar 2011 // 11:00PM GMT
In the Mediator story, the narrative mainly states the fact that adverse effects are huge compared to drug’s revenues and yet these effects did not lead to the withdrawal of the product from the market. As a result, the reliability of the French drug system is immensely challenged.
At the end of January 2011, the French President required a report about Mediator to be shared with both Bernard Debré and Philippe Even (two French deputies, also doctors). In total, Mediator had documented 500 to 2,000 deaths in about thirty years.
The audit by the two doctors was highly challenging for the current French drug system and highlighted that the majority of drugs were ‘useless’ and 12 percent of therapies are ‘potentially dangerous.’ As a consequence, they recommend non-reimbursement for 1000 to 2000 ‘useless therapies’ which currently cost between one to two billion Euros for the national health insurance system.
They also plan ‘to pay and to reimburse new drugs according to what they really bring.’ To assess this thoroughly new therapies must be compared with older therapies and not with a placebo, in order to ‘allow a valid comparison’. In other words, only the improvement of the medical effect will be considered.
The report stresses that this situation has been created by an AFSSAPS failure to deliver (Agence Française de Sécurité Sanitaire des Produits de Santé: the French drug approval system) and proposes to transform AFSSAPS into a drug agency combining two autonomous agencies, that would achieve the following:
- Evaluation of drugs and health products (AEMPS Agence d'évaluation du médicament et des produits de santé), which would judge the appropriate labeling and the marketing of drugs
- Pharmacovigilance (AFPV Agence française de pharmacovigilance), in charge of drug follow-up and monitoring to review potential adverse events
The success of this agency will depend on its organizational abilities, but also on the quality of people employed. The agency should integrate internal experts, without a conflict of interest, which were considered high level and detached from university linked responsibility.
As a final result, in February 2011, the French president has decided to dismiss the current AFSSAPS director Jean Marimbert who’s being replaced by Dominique Maraninchi (ex Director of National Cancer institute).
The Perception of French People on the Mediator Crisis
After Mediator’s scandal, the loss of confidence and trust of French people on health products has become high. According to a CSA survey conducted for the ‘Parisien’ – ‘Aujourd’hui en France’ (National Dailies) in January 2011, a third of French people are suspicious about drugs: 35 percent are not confident (21 percent ‘rather not confident’ and 14 percent ‘not at all confident’).
This study also reveals that younger people (18 to 24 years old) are the most trustful and that the 50-64 years old are increasingly more and more worried (43 percent not confident).
However, despite these findings French people do not challenge the entire health system: 94 percent are confident in their general practitioner and 90 percent trust their pharmacists.
The Effect on the Pharma Industry
Following the Mediator story, AFSSAPS has communicated a list of 77 drugs to be closely monitored: "This list is the first, patients should be more reassured than anxious as these drugs are simply being monitored, but are not necessarily for future withdrawal.”
The challenge has been that AFSSAPS did not make any distinctions in this list, which created a massive concern among patients (e.g. with Levothyrox indicated in the treatment of thyroid, only the dosage is under monitoring in the case of a switch to a generic).
The trade union of general practitioners in France proposes the following classification:
- Drugs monitored for their effectiveness, as the vaccine Prevenar (against the invasions with pneumococci)
- Drugs monitored for their bioequivalence, between the original molecule and generic
- Drugs monitored with benefit/risk ratio under discussion
As a result, the pharmaceutical industry has become even more sensitive in communicating about their drugs, specifically when they are highlighted on the list as they have a long history of confidentiality and legal constraints, which are more significant in France than other EU countries.
The launch of new drugs are now delivered in a much more toned down way, with low share of voice and exclusively to HCPs who are more and more questioning the drugs’ value: clinical benefit versus the longer term cost implications.
Some pharmaceutical companies are making efforts to be as transparent as possible in response to the situation, such as Novartis who has put in place a free call line for physicians to ask questions about drugs on the list, as well as an internet access facility.
This overall crisis could have been avoided if pharmaceutical industry has been more transparent about its business model (R&D, acquisition, costs of drug development, patient advocacy group engagement, etc.) and of course if some of them, such as Servier (Mediator manufacturer) were more ethical.
The Mediator crisis has been interesting, it has brought about a new era, so it’s now time that the pharmaceutical industry creates a relationship with both patients and public in an open and more transparent way!
Isabelle Genin is head of healthcare communications specialist Chandler Chicco Companies in Paris. She previously was general manager of Saatchi & Saatchi Healthcare Paris.