Sunday, January 06, 2013

Mediator - 500 deaths

France shaken by fresh scandal over weight-loss drug linked to deaths


Mediator, which was prescribed as an appetite suppressant and is believed to have killed at least 500 people.

A weight-loss drug believed to have killed hundreds of people in France's biggest pharmaceutical scandal has sparked fresh controversy as victims complain of delays in state compensation and a leading 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 pounds.

According to the French health ministry, it has killed at least 500 people from heart-valve damage, but other studies put the death toll nearer to 2,000. Thousands more complain of cardiovascular complications that have limited their daily lives.

As many as 5 million people were given the drug between 1976 and November 2009, when it was withdrawn in France, years after being pulled in Spain and Italy.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 UK or US.

The scandal, which has prompted the resignation of the head of France's public health agency, sparked a furore about drugs regulation 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 expected to start in spring. The company has denied the accusations.

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 Less than a year before Mediator was withdrawn, he was awarded France's highest state honour, the Legion d'Honneur, by Nicolas Sarkozy – who once acted as his lawyer.

Dominique Courtois, of Avim, a Bordeaux-based association dealing with thousands of victims' cases, said victims were finally being heard. He added: "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 GPs are being listened to."

Daniele Mourhlon, 71, a retired police administrator from Albi, had a thyroid problem when she was prescribed with Mediator to avoid gaining weight. She said: "Ironically I was actually never a person who 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." But it had a terrible side-effect. "My kids said: 'Mum, you're speaking quietly, walking slowly.' It's as if I was on tranquilisers. 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 hike any more. My life expectancy has been reduced. I'm angry with the pharmaceutical labs. I never would have taken it if I'd known."

Joseph Reynel, 78, a retired IT worker, has type two diabetes and was prescribed the drug from 2003 to 2009. He now has heart valve disorder and 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 pint of milk. So I had to leave and rent another apartment 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."

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