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Clampdown on dodgy diet drug, Mediator

A weight-loss drug believed to have killed hundreds in France's biggest pharmaceutical scandal has sparked fresh controversy as victims complain of delays in state compensation and a major drug company boss has been placed under formal investigation for manslaughter.

The amphetamine derivative Mediator was marketed to overweight diabetics but often prescribed to healthy women as an appetite suppressant when they wanted to lose a few kilograms. According to the health ministry it has killed at least 500 people from heart valve damage, but other studies put the death toll nearer to 2000. Thousands more complain of cardiovascular complications.

As many as five million people were given the drug between 1976 and November 2009, when it was withdrawn in France, years after being pulled in Spain and Italy. It was never authorised in the United Kingdom or the United States.

The scandal, which has already prompted the resignation of the head of France's public health agency, sparked a furore about drug regulations and the lobbying power of pharmaceutical companies in France, which has one of Europe's highest levels of consumption of prescription drugs.

Mediator is now at the centre of one of the most important medical legal battles of the year. Along with the prosecution over the French-made faulty PIP silicone breast implants, it has shaken the French medical world.

Recently Louis Servier, the 90-year-old head and founder of France's second biggest drugs company, which created Mediator, was placed under formal investigation on suspicion of manslaughter. A related trial to determine whether the Servier company misled patients and authorities about the drug was postponed and is still pending. The company has denied the accusations.

Logical development
Servier has long been a powerful figure in the Paris establishment. Less than a year before Mediator was withdrawn, he was awarded France's highest state honour, the Legion d'Honneur, by Nicolas Sarkozy – who once acted as his lawyer.

Dr Irene Frachon – who revealed the dangers while she was studying complications linked to a similar Servier appetite suppressant drug, Isomeride, which was withdrawn in 1997 – said the Mediator manslaughter charge was "a logical development" in the long-running legal saga. "It's deeply symbolic because it means that victims have been identified. I still don't know if France has learned its lesson from this. France was very shaken, but the pharmaceutical structure and lobby is still very strong. Maybe a trial will help [to] change that."

She warned there was still an uphill struggle for recognition of and compensation for the victims.

Dominique Courtois of Avim, a Bordeaux-based association dealing with thousands of victims' cases, said they were finally being heard. "The manslaughter charge is very important. That the justice system has made the link between the deaths and the drug is key. There were lots of doctors who saw problems but no one listened. Now patients and doctors are being listened to."

Daniele Mourhlon, a retired police administrator from Albi, had a thyroid problem when she was prescribed Mediator to avoid gaining weight. She said: "Ironically I never carried extra weight. I had had three kids and people always said how slim I looked. I cooked healthily and loved long hikes. But I followed the doctor's orders and took Mediator three times a day for five years and it cut my appetite."

Personal expense
But it had a terrible side effect. "My kids said I was speaking quietly, walking slowly. It's as though I was on tranquilisers. They didn't think I was myself. They thought there was something odd about me."

Mourhlon had to have open-heart surgery on three valves after damage from the drug. "Since then I'm very fragile. I'm dependent on medication. I have problems breathing and can't do even the smallest things. I can't do housework, I can't bend down. I can't hike any more. My life expectancy has been reduced. I'm angry with the pharmaceutical labs. I never would have taken it if I had known."

Joseph Reynel, a retired information technology worker, has type 2 diabetes and was prescribed the drug from 2003 to 2009. He now has heart valve disorder and regularly struggles for breath.

"My flat is on the third floor without a lift. It got to the stage where I couldn't climb the stairs carrying a bottle of milk. So I had to rent another flat at great personal expense. The judicial process is slow and there has been no movement on parallel compensation claims. But what stuns me is the lack of support from the state, even psychological support. The victims are the ones who have to bear the consequences of this and we have been totally abandoned." – © Guardian News & Media 2013

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