減量薬で５００人死亡か、仏製薬大手と薬事当局の刑事裁判開始

【パリＡＦＰ＝時事】フランスで、安全性の懸念があったにもかかわらず糖尿病薬が減量薬として処方され、少なくとも500人の死亡事例に関係したとされる問題で、薬事監視当局と製薬大手に対する刑事裁判が23日に始まった。（写真は糖尿病薬「メディアトール」）
　肥満の糖尿病患者向けに開発された「メディアトール」は、食欲抑制薬として健康な人にも広く処方された。３３年間市場に出回り、使用者は約５００万人に上る。
　服用後に心臓弁に異常を来し、仏国内で少なくとも５００人が死亡したとみられている。専門家らの推算によると、長期的には最大で２１００人の死亡事例に関わる恐れがあるという。
　同国の製薬最大手の一つ、セルビエとその子会社９社、さらに医薬品・保健製品安全庁（ＡＮＳＭ）に対する刑事裁判の審理は、６か月間に及ぶ見通し。
　メディアトールの安全性の懸念が最初に指摘されたのは１９９０年代半ば。フランス国内で同薬が禁止されたのは、米国やスペイン、イタリアで禁止されたずっと後の２００９年だった。
　約２５０人の原告団の代理人は、被害者らは「この薬がなぜこれほど長く市場に残り得たのかを究明したい考えだ」と述べている。
　セルビエは、メディアトールのリスクを隠蔽（いんぺい）したとして詐欺の罪に問われている。一方ＡＮＳＭは、業務上の過失に加え、同薬の禁止が遅れた責任追及を受ける。いずれも罰金または被害者への賠償金の支払いが言い渡される可能性がある。【翻訳編集ＡＦＰＢＢＮｅｗｓ】
〔ＡＦＰ＝時事〕（2019/09/24-11:15）

France's medicines watchdog joins pharmaceutical firm Servier in the dock Monday on fraud and negligence charges linked to the deaths of hundreds of people who were prescribed a diabetes pill for weight loss despite safety concerns.
At least 500 people are thought to have died of heart valve problems in France after taking the drug Mediator, in a major health scandal that was the subject of a 2016 French movie called 150 Milligrams.
The film is based on the work of real-life pulmonologist Irene Frachon who was instrumental in bringing the alleged wrongdoing to light through her campaigning and investigation.
She is expected to testify against the company and the medicine, which was on the market for 33 years and was used by about five million people.
Experts have projected it may cause as many as 2,100 deaths in the long term.
The criminal trial against Servier, nine subsidiaries, and the ANSM medicines watchdog -- known at the time as Afssaps -- is expected to last six months.
It will focus on 91 victims, four of them deceased, for whom lawyers believe a link can be shown between their illness and Mediator.
Twelve individuals in the dock will include former Servier number two Jean-Philippe Seta, doctors who were members of Afssaps commissions while also being paid as pharma company consultants, and former senator Marie-Therese Hermange who produced a report said to be favourable to Servier.
Initially intended for overweight people with diabetes, the drug was widely given to healthy individuals as an appetite suppressant.
Safety alerts were first flagged in the mid-1990s, but Mediator was banned in France only in 2009 -- long after being outlawed in the United States, Spain and Italy.
Victims want to understand how this medicine could have been left on the market for so long, said Charles Joseph-Oudin, who will represent about 250 complainants in the trial in the Paris criminal court.
- 'Poison' -
Servier, one of France's biggest pharma firms, is charged with fraud for allegedly concealing Mediator's risks, while the ANSM is being pursued for negligence and allegedly dragging its feet in suspending the drug. They risk a fine or an order to compensate victims.
Servier knew that it was selling poison, said 71-year-old Joy Ercole, who took Mediator for six months 10 years ago, and said she suffered heart damage as a result.
The unlucky ones, like me, are condemned to a slow death. My life is ruined.
Servier says it did not know about the risk before 2009.
Frachon had alerted French health authorities of heart problems among patients who had taken the drug. She published a book in 2010, which became the basis of movies made about her.
The ANSM in 2010 linked at least 500 deaths to Mediator.
In 2015, a civil court found Servier negligent for having left defective medicine on the market.
Victims have submitted nearly 10,500 claims for compensation from Servier, and many have accepted payment in return for not taking part in criminal proceedings.
Servier's website states it has made offers of compensation to more than 3,700 sickened people for a total amount of 164.4 million euros ($182 million), of which 131.8 million euros have been paid out.
About 100 witnesses are expected to take the stand, including Frachon.