Man Dies in France After Painkiller Drug Trial
By THE ASSOCIATED PRESS

PARIS — A man died in a French hospital on Sunday after taking part in an experimental drug trial for a painkiller, while five other participants remained hospitalized.

French prosecutors have begun a manslaughter investigation into the unusual case, which shined a spotlight on the practice of testing drugs on paid, healthy human volunteers. Scores of others were also given the drug.

The Portuguese pharmaceutical company testing the drug, Bial, said in a statement that it was working with health authorities to determine what caused “this tragic and unfortunate situation.”

The Rennes University Hospital in western France announced the death in a statement, but did not identify the patient, who was among six male volunteers between 28 and 49 hospitalized last week after volunteering to take the drug. French health authorities have said three of the hospitalized volunteers may suffer brain damage.

The Paris prosecutor’s office said the investigation was expanded after the death to include potential manslaughter charges.

The drug trial, which began Jan. 7, involved 90 healthy volunteers who were given the experimental drug in varying doses at different times. The hospital said it had contacted the 84 other volunteers exposed to the new painkiller. Ten of those volunteers underwent medical exams on Saturday, but the hospital said it found no anomalies. It said another five would have medical exams closer to their homes, but did not say whether the others were being monitored or tested.

France’s minister of health, Marisol Touraine, said that the drug, in addition to treating pain, was also intended to ease mood and anxiety troubles as well as motor problems linked to neurodegenerative illnesses. Ms. Touraine said the drug was not based on marijuana or cannabis, as some reported.

Bial said that clinical trials started last June after toxicology tests and that 108 healthy people had already taken part in trials with no moderate or serious reactions.

法國新藥試驗出事 1死5住院

葡萄牙藥廠Bial研發止痛藥，在法國徵求自願試用者進行藥物試驗，一名參加試用的男子17日在醫院死亡，另有五人住院，成為法國歷來最嚴重的藥物試用悲劇。

Bial聲明表示正在與法國衛生當局合作，以便研判「這個悲劇與不幸情況」的肇因。

法國西部雷恩大學醫院17日宣布這名20多歲男子的死訊，只說他腦死，未提姓名。這名男子和另外五人年齡從28到49歲不等，自願參加新藥試用後，六人上周因腦傷住院。雷恩大學醫院神經部表示，仍然住院的五人之中，三人可能有無法恢復的大腦損害。

本案凸顯藥廠實驗新藥而付錢徵求健康人試用的老問題，巴黎檢方表示，有人死亡之後，調查已經擴大，可能加上殺人罪的調查。

法國衛生部長瑪莉索爾．杜雷納表示，新藥計畫三波試用，首波人體試用經過法國醫藥與衛生產品安全署（ANSM）批准，從去年6月開始，迄今總共已有108人參加，其中有人服用安慰劑。餘90人從本月7日起實驗，服用劑量各不相同，生病的六人試用的劑量最大；三天後，一人感覺不適而住院，接著又五人入院。

雷恩大學醫院表示，已聯絡其餘84位試用者，其中十人16日經過檢查，未見異常。

這批口服試用屬於「階段1」試用，Bial委託坐落雷恩的國際知名藥物評估公司Biotrial（直譯「生物試驗」）執行。

杜雷納表示，試用的藥物是一種「脂肪酸胺水解酶阻斷劑」（FAAH inhibitor），除了止痛，另一目標用途是對控制疼痛的內源性大麻素系統（endocannabinoid system）發揮作用，緩解與神經退化症相關的情緒、焦慮及運動神經問題。

藥物的「階段1」試用，是在身體健康的試用者身上研究使用安全、副作用，而非藥效，因此試用者病倒的例子十分罕見。

原文參照：
http://www.nytimes.com/2016/01/18/business/international/man-dies-in-france-after-painkiller-drug-trial.html

2016-01-18．聯合晚報．A6．國際焦點．編譯彭淮棟