PARIS: France'smedicines watchdog will join a pharma firm in the dock from Monday on fraud andnegligence charges linked to the deaths of multiple people prescribed adiabetes pill for weight loss despite safety concerns. At least 500 people arethought to have died of heart valve problems in France after taking the drug,Mediator, in a major health scandal that became the subject of a 2016 Frenchmovie called "150 Milligrams".
Legal expertshave concluded the drug may cause as many as 2,100 deaths in the long term. Thecriminal trial, with 12 individuals in the dock, will focus on 91 victims, fourof them deceased, for whom lawyers believe a link can be shown between theirillness and Mediator. The medicine was on the market for 33 years, and used byabout five million people.
Though initiallyintended for overweight people with diabetes, it was widely prescribed tohealthy individuals as an appetite suppressant. Safety alerts were first flaggedin the mid-1990s, but the drug was only banned in France in 2009 -- long afterbeing outlawed in the United States, Spain and Italy.
Victims"want to understand how this medicine could have been left on the marketfor so long," said Charles Joseph-Oudin, who will represent about 250complainants in the trial expected to run for six months in the Paris criminalcourt. Drug manufacturer Servier and nine subsidiaries are charged with fraudfor allegedly concealing Mediator's risks, while the ANSM drug watchdog isbeing pursued for negligence and allegedly dragging its feet in suspending thedrug.
'Selling poison'
At the end of thetrial, both risk a fine or an order to compensate victims. "Servier knewthat it was selling poison," said 71-year-old Joy Ercole, who tookMediator for six months ten years ago, and said she suffered heart damage as aresult. "The unlucky ones, like me, are condemned to a slow death. My lifeis ruined."
Francois deCastro, a lawyer for Servier, said the company was "keen to come andexplain that they did not identify the risk before 2009." PulmonologistIrene Frachon had alerted French health authorities of heart problems amongpatients who had taken the drug. She published a book in 2010, which became thebasis for a documentary movie.
In 2015, a civilcourt found Servier negligent for having left "defective" medicine onthe market. It ruled that in 2003 and 2006, when the medicine was prescribed totwo claimants, "the state of scientific knowledge meant the risks ofpulmonary hypertension" and heart valve damage "could not beignored". The ANSM, then known as Afssaps, in 2010 linked at least 500deaths to Mediator. Victims have submitted nearly 10,500 claims forcompensation from Servier, and many have accepted payment in return for nottaking part in criminal proceedings.
'Unpunished'
Servier's websitestates it has made offers of compensation to more than 3,700 sickened peoplefor a total amount of 164.4 million euros ($182 million), of which 131.8million euros have been paid out. The amounts range from a few thousand eurosper person to a million euros in one case.
About 100witnesses are expected to take the stand, including Frachon, who told AFP aheadof the trial it was time for justice to be served. "We cannot live in asociety where white collar crime goes unpunished," she said. The trialwill happen in the absence of a key protagonist: company founder JacquesServier who died aged 92 in 2014.
The 12individuals on trial include Servier's former number two Jean-Philippe Seta,doctors who were members of Afssaps commissions but were also paid asconsultants for pharma companies, and former senator Marie-Therese Hermange whois accused of producing a report that was favorable to Servier.
France has seenits share of medical scandals. These include 36 baby deaths in the 1970s linkedto a contaminated talcum powder, HIV-contaminated blood given to haemophiliacsin the 1980s, and the recent discovery that a popular brand of breast implantscontained a cheap, industrial-grade-not medical-grade-silicone gel. - AFP