THE story of the woman who revealed the biggest pharmaceutical drug scandal in France in recent years is being filmed for the big screen by the actress and film director, Emmanuelle Bercot, prize winner at the Cannes Film Festival.
La fille de Brest tells how Dr Irène Frachon, a lung specialist at the Brest Hospital in Brittany, fought to get the slimming drug Mediator withdrawn from sale after she discovered that it caused serious side-effects including heart valve disease and pulmonary hypertension. She continues to help victims claim damages in the courts against the French drug company Servier, whose founder had links to the then-French president Nicolas Sarkozy.
The drug Mediator, also known as Benfluorex, was withdrawn from sale in France in November 2009 and has been blamed for causing the deaths of between 500 and 2,000 people and causing heart damage to thousands of other users. The drug had already been withdrawn from Spain and Italy and it was never authorised in the UK or US.
It had been used as an appetite suppressant which was initially prescribed for diabetics but later commonly used as a slimming aid. It is estimated that more than five million people in France were taking it at its peak and it was selling seven million boxes a year.
The consequences of the affair have been far reaching. The former drug regulatory body AFSSAPS was criticised for its slow reaction to the dangers of Mediator and was replaced by the ANSM, Agence Nationale de Sécurité du Médicament in 2012. The new agency has wider powers to review drugs, is totally funded by public money, and includes patients’ representatives on the board of directors in an attempt to increase transparency.
In 2012 an investigation into manslaughter was launched against the founder of the company Jacques Servier, however he died in 2014, aged 92, before any case was brought. Servier was a powerful man in French society and had close links with Sarkozy who awarded him the Grand Cross of the Légion d’Honneur in 2008.
Servier was also one of the clients of the legal firm where Sarkozy worked before entering politics.
There are now criminal proceedings involving corruption, collusion and complicity against various people and bodies associated with the Mediator scandal but so far there have been no hearings. Le Figaro has reported that proceedings will not begin until 2018 when it is scheduled to be the first case to be heard in the new law courts currently under construction at Batignolles in Paris.
In the civil courts victims have been awarded damages but there is a long list of cases still to be heard.
The French state has also been held accountable with a legal ruling that AFSSAPS should have withdrawn the drug as early as June 1999 when the first case of heart valve disease was attributed to benfluorex.
La fille de Brest is due to be released in autumn 2016.
How did it start?
I never set out to do so when I became a doctor but a series of events meant that I felt I had no option other than to find out the truth about Mediator.
It began when I was 25 and working in the Pulmonary and Respiratory Diseases Department of a hospital and came across patients suffering from the effects of another Servier drug called Isoméride.
As a young doctor I was truly shocked at how difficult it was to get the drug banned when I could see how ill people were as a result of taking it but in 1997 it was withdrawn worldwide.
The drug was sold under the name Redux in the States and there the victims were awarded millions of dollars in compensation. There was nothing for people in France.
Ten years later I was working in Brest hospital and I began seeing patients with similar conditions. Even though I could not conceive that the same molecule responsible for the earlier illnesses could possibly still be present in medicines I read about similarities between Mediator and Isoméride in a medical review, Préscrire.
I started to talk to patients and other doctors and we started to see a link.
After much research we realised that, though the two drugs were slightly different in pill form, once they entered the body they were both transformed into a substance known as Norfenfluramine which was the active element causing heart problems.
I contacted Servier who denied any problems with their drug.
It was like a detective novel. By 2008 I was convinced of the link between Mediator and health problems in patients. So I went to look for patients and I did it via the hospital records to see if people with heart problems had taken Mediator. And I found that many of them had.
A doctor in the Social Security helped by looking at cases throughout France. In 2009 I took my findings to the agency responsible for assessing the benefits and risks of health products but they didn’t believe me. It was very difficult because I was heavily criticised for my actions and it took nearly a whole year to persuade the agency that Mediator should be withdrawn and at last it was no longer legal in France.
Why did you continue the battle?
I was then appalled and horrified that the people who had been taking Mediator weren’t told why the drug had been banned and about the effects it had had on their lives. It was scandalous. So I wrote a book Mediator 150mg: How many deaths?. Servier immediately took me to court and the book was banned though it was later reinstated on appeal.
After the appearance of the book I began to receive extremely unpleasant and threatening emails and there was a great deal of pressure on me.
How many people do you think have died as a result of taking Mediator?
It is difficult to give an exact figure but I think more than 2,000 people have died and tens of thousands are suffering from the effects.
It is an extremely distressing condition and many people have had their lives reduced and have had to stop working. Many, many people are now fighting for compensation in the courts but that too is a double burden for the victims.
First they are ill and second, they have to have the courage and energy to go through a court case which is long and costly and very difficult because Servier fight every detail and every technical point. So far about 1,400 people have won some compensation but at least another 1,400 are still waiting.
Why do you think it was so difficult to get the drug withdrawn?
It is a question of money and power. A slimming drug is very lucrative.
What lessons do you think we can learn from the affair?
There have been some reforms in the system but I think it is very difficult to unravel the close links doctors have with the pharmaceutical companies. It is a very complicated relationship and there are certainly no easy answers.
Sadly, I am afraid that if there is another drug out there causing severe health risks we could see the same story all over again.
Most people would say that you were courageous to take on a powerful pharmaceutical company. Do you think you are brave?
As I said earlier I became involved because of a set of circumstances I couldn’t ignore. I like my patients and I was revolted by what was happening to them. I don’t think I am brave. I think I am normal. But I do think there are a lot of people who see things that are wrong but don’t react and let things go on without fighting, a lot of laissez faire.
A quote by Albert Einstein sums it up: “The world is a dangerous place to live in, not because of the people who are evil, but because of the people who don’t do anything about it.”
Are you proud that a film is being made about you?
I think the message it will give is important. When I started out as a doctor I believed in the medical system. But now I know differently. It is vital that people understand that their health is not sacred and that health is big business.
So we must ask questions and take more responsibility over the way in which we are treated.