French daily Le Figaro reported on Saturday that the French Drug
Agency (l’Agence du medicament) [ ΠΡΟΣΟΧΗ ! ΤΟ ΑΡΘΡΟ ΑΠΟΦΕΥΓΕΙ ΝΑ ΑΝΑΦΕΡΕΙ ΟΤΙ Η ΦΑΡΜΚΟΒΙΟΜΗΧΑΝΙΑ ΗΤΑΝ Ο ΓΑΛΛΙΚΟΣ ΚΟΛΟΣΣΟΣ SERVIER! ] was warned about Mediator, an
amphetamine-based drug widely used by non-diabetics as an appetite
suppressant, in 1998.
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The letter also pointed out the irony that while amphetamines were
strictly controlled, Mediator was being quite freely prescribed.
Mediator, which has been linked to heart valve problems, was
finally taken off the French market in 2009, well after it had been
banned in Spain, Italy and the USA.
Despite repeated warnings, the drug, made by French company
Servier, remained freely prescribed and reimbursed by the state at the
maximum rate of 65%, which undoubtedly helped maintain sales.
1976: Benfluorex, under the trade name Mediator,
comes on the market. Designed for diabetics, it is also prescribed as an
appetite suppressant
1997: Isomeride, an appetite suppressant also made by Servier, is taken off the market after being linked to heart valve problems.
1998: Swiss medical authorities note that
Benfluorex shares similar compounds with Isomeride, and asks Servier
about risks associated to Mediator.
Three French medical professors write to the French Drug Agency
(l’Agence du medicament) warning about the overuse of Mediator, pointing
out that it is amphetamine-based.
2001: Proposals are made to take Mediator
off the list of prescribed drugs reimbursed by the French social
security system. Further similar recommendations are made in 2006.
Nevertheless, Mediator keeps its status as a reimbursed drug (at the maximum 65%) until it is banned in 2009.
2003: The first case of heart valve problems is linked to the drug in Spain, where it is removed from the market. Italy follows suit.
2006: Doctors in Toulouse link a heart condition to Benfluorex.
A commission set up by French health authorities concludes
that Benfluorex has “severe side effects, including heart conditions”,
and that it should be taken off the market. However, it remains
reimbursed at the maximum 65%.
2007: Prescription of Mediator is
restricted to diabetics only (a 1998 report showed that 35% of
prescriptions were for women who did not have diabetes.)
November 2009: After 33 years on the market, Benfluorex (Mediator) is banned in France.
May 2010: A woman who had taken Mediator for seven years takes Servier to court following heart surgery.
October: The Figaro reports a study estimating up to 1,000 deaths from patients using mediator.
November: Patients who have taken Mediator are advised to seek medical attention.
December: An inquiry is called by the French National Assembly
Ironically, just before the pill was banned, President Nicolas Sarkozy awarded Servier's founder, Dr Jacques Servier, the Legion d'Honneur, which is the highest French decoration.
Opposition
politicians are accusing the government of being too close to the
pharmaceutical industry and risking lives to protect profits. And now lawyers countrywide are set to sue Servier for criminal negligence and involuntary murder.
In response to the crisis, the French government is now set to conduct a review as to why the product was kept on the market so long, and last week Sarkozy said the public deserves no less than "total transparency".
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