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Mediator
one of France's biggest medical scandals of recent years
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what's Mediator |
Mediator was marketed to overweight diabetics but often prescribed to healthy woman as an appetite suppressant when they wanted to lose a few pounds.
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what Happened |
By now, the drug has killed at least 1800 people (diabetics and healthy people) from heart valve damage. On top of that, 4200 people have cardiovascular complications (kidney failure and strokes) that limited their daily lives.
The drug was sold to 5.000.000 people between 1976 and 2009
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who's responsible |
Mediator was produced by Servier Labaratories, France's second biggest pharmaceutical company.. Jacques Servier, head and founder of Servier, faces charges of 'aggravated deception', and manslaughter. |
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How could this deadly drug be on the market for 33 years without someone taking action? Who are to blame and who are involved?
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We first take a look at how the affair unfolds from the creation of the drug to the most recent events in Servier's trial.
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USA
UK The drug was never authorised in these countries.
Irene Franchon
publishes book about Mediator
Belgium
Netherlands
Spain
Italy
Portugal
Cyprus
Luxembourg |
Servier withdraws Benfluorex by not re-applying for marketing authorisation
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France
Worldwide |
November 2009,
AFSSAPS suspends marketing of Benfluorex in France, citing both efficacy and safety issues. Servier withdraws the drug worldwide |
IGAS publishes report about the "Mediator scandal"
| Italian regulators raise concern because of the pharmacovigilance investigation of Benfluorex |
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Two cases of cardiovascular complications. This is the year in which benfluorex should have been withdrawn. |
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Irene Frachon (physician) discovers dangers of Mediator in own research |
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Servier creates three types of drugs:
Fenfluoramine
Enfluramine
Benfluorex (Mediator)
All three drugs are pharmacologically linked. Yet, Servier classifies them separately, for different types of diseases.
20 years later, this has serious consequences when the AFFSSAPS takes down the fenfluramines but not Benfluorex, because of the classification.
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healthcare organisation IGAS
notifications from the 2011 report
countries selling Mediator
(no data from Asia and Afrika)
medicines Agency AFSSAPS
French drug regulators
Trail against Servier
Under a European Directive, benfluorex (and all other drugs approved before 1976) is re-assessed, and approval in the diabetes setting is not upheld. A revised marketing approval is not issued
The use of Fenfluoramine is restricted because of cardiovascular safety concerns.
1997
Fenfluoramine is withdrawn, but benfluorex remains on the market. French drug regulator AFSSAPS revokes approval of benfluorex for diabetes in April, only to rescind the action 2 months later.
1998
Benfluorex placed under "official" pharmacovigilance investigation in France, due to its "potential danger".
Enfluramine
taken off the market
AFSSAPS is aware of the expired but fails to take action
AFSSAPS begins another review of benfluorex safety. Approval for hyperlipidaemia, but not diabetes, is revoked.
AFSSAPS publishes study
based on data from
insurers.
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Januari 2011
French association of drug manufacturers (LEEM) suspends Servier in an attempt to distance themselvesfrom the affair.
Februari 2011
First trail, Servier offers victems 20 million.
116 charges so far.
May 2014
Servier charged with:
- aggravated deception
- medical injury
- manslaughter
- (corruption, related trail)
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| personal connections and money
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| money |
| pressure and influence |
| monitoring and research |
pharmaceutical industry, Servier |
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| donations |
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lobbying |
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lawsuit
threats |
French drug authorities and
medical community.
AFSSAPS and LEEM
2008
Jacques Servier receives highest award in knightly order of French President Nicolas Sarkozy. Sarkozy used to be the lawyer of Servier.
1999
Cardiologist Chiche contact the authorities because of his
concerns regarding Mediator. Later he was called by a
local politician who sentenced him that there was no link between the
drug and the side effects.
French government
It's clear that despite the obvious signs it still took 33 years before the drug was fully banned. The answer lies within these four key culprits:
- Distinct classifications of Benfluorex by Servier
- Overly complex bureaucracy and fear of litigation within AFSSAPS
- Aggressive marketing tactics by Servier
- Unhealthy ties between industry and regulators
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AFSSAPS recently published a list of
77 drugs that it has placed "under
reinforced surveillance" because of
undesirable side-eff
ects. But some still
wonder how effectively the agency
would be able to take action on these.
These culprits seem to be the base of a bigger problem that involves the entire health care system. With the lobbying power of the pharmaceutical companies and the inefficiency of organizations like AFSSAPS it's just waiting for a new disaster.
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