13/08/2015

Drugmaker accused of omitting side effect data 藥廠被指控隱匿臨床試驗的副作用


藥廠被指控隱匿臨床試驗的副作用

早期J&J的跨國臨床試驗報告risperidone沒有prolactin異常的問題,這和臨床經驗大大相左,因此在2000年代早期我就定期檢驗服用risperidone病患的prolactin濃度(還被健保核刪幾次),並2006發表論文指出這個副作用非常明顯(1。當時J&J都是用早期的跨國臨床試驗報告來反駁我的論文。近年來,果然有病患出問題,今年J&J為了這個副作用賠償250萬美元(2,國內也有醫師因此被告。不幸的是,過了十幾年、影響了多少病患(特別是青少年的個案),有問題的臨床試驗才被提出來檢討3


「藥廠在藥物臨床試驗中造假,對病患造成傷害」,醫療人員應該要和病患一同聲明譴責!因為,接受到誤導性研究的影響,不但病患受到傷害,醫師的信賴度也會被置疑,因為病患受害而引發訴訟和糾紛,醫師也間接成為受害者。絕大部分的科學家是誠實的,絕大部分的醫學研究是可信賴的,如果對有問題的研究結果保持沈默,那麼醫界和學術界的信譽就會被危及,反醫學者就有詆毀的空間。




Authors accused the drugmaker to omit side effect data in a clinical trial
The early J&J drug trials (2000s) reported that the prolactin issue was not significant, which surprised me very much. From clinical experience of me and my colleagues, the increased levels of prolactin in patients taking risperidone had been clinically significant. Since early 2000, I check the prolactin levels regularly in every patient with risperidone therapy. I also conducted a clinical observational, crossover study and confirmed the safety problem (1, Lin et al JCP 2006). At that time, J&J was not happy when I presented our study and argued with the results of those early drug trials. Unfortunately, it takes many years and many harmed patients (2) to start the discussion about the retraction of those problematic trials (3). 




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