Ousted Novartis scientist 'categorically denies' wrongdoing in data manipulation scandal

我们的诺华( Novartis )科学家“断然否认”数据操纵丑闻中的不当行为

2019-08-21 02:46:35 CNBC

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One of two top scientists said to be ousted from Swiss drug giant Novartis in connection with a data manipulation scandal is denying any wrongdoing. Brian Kaspar, previously chief scientific officer of AveXis, the biotech company that developed Novartis's gene therapy, Zolgensma, "is a respected member of the scientific community with an impeccable record," his attorney, John Hueston of Hueston Hennigan, said in an e-mailed statement. Novartis said last week that Kaspar, along with his brother, Allan Kaspar, who led research and development at AveXis, hadn't been involved with the company since May. Though the company didn't say so explicitly, a person familiar with the matter said last week their departure was related to the issue of manipulated data that supported Zolgensma's approval by the Food and Drug Administration. The report by the FDA earlier this month that Novartis not only relied on manipulated data in the drug's application, but did so knowingly, has put pressure on its chief executive, Vas Narasimhan. In a conference call with analysts, Narasimhan said Novartis waited to alert the agency about the data manipulation until it had completed its own investigation — about a month after the drug was approved. Both the FDA and Novartis said the data in question didn't concern the drug's safety and efficacy, and that Zolgensma should remain on the market. The Kaspars were among a handful of scientists who were fired in connection with the data manipulation, said the person, who declined to be named because an investigation into the situation is ongoing. The event has attracted particular scrutiny because of Zolgensma's price tag: $2.1 million for the single treatment. It's considered a breakthrough in the treatment of spinal muscular atrophy, a rare and devastating childhood disease. Novartis acquired AveXis last year for $8.7 billion. The FDA has threatened potential civil or criminal penalties against the company. Kaspar "stands proudly behind the safety and efficacy of the drug that he and his team worked so hard to develop," the statement from his attorney said. "He has cooperated with AveXis's internal investigation, and he categorically denies any wrongdoing. He is prepared to assert his rights and defend his conduct accordingly. Dr. Kaspar continues to wish the clinicians and the company continued success in the treatment of children with this deadly and devastating disease." Kaspar's attorney, Hueston, is no stranger to corporate controversy: He defended Tesla CEO Elon Musk in the Securities and Exchange Commission case over Musk's tweets. Hueston was also lead prosecutor in the 2006 case against Enron executives Kenneth Lay and Jeffrey Skilling, in which both men were convicted of securities and wire fraud. Hueston said he does not represent Kaspar's brother, Allan, who has not responded to a message seeking comment.
瑞士制药巨头诺华公司( Novartis )因数据操纵丑闻被免职的两位顶尖科学家之一,否认存在任何不当行为。 开发诺华(Novartis)基因疗法的生物技术公司 AveXis 的前首席科学家 BrianKaspar 在一份电子邮件声明中说:“他是科学界受尊敬的成员,有着无可挑剔的记录。” 诺华(Novartis)上周表示, Kaspar 和他的兄弟 Allan Kaspar 自5月份以来一直没有参与公司的研发。 Kaspar 和他的兄弟 Allan Kaspar 领导着 AveXis 的研发。一位知情人士上周表示,他们的离职与操纵数据的问题有关,这些数据支持佐尔甘斯曼获得美国食品和药物管理局( FDA )的批准。 FDA 本月早些时候发布的这份报告称,诺华(Novartis)不仅依赖该药物申请中的操纵数据,而且在知情的情况下也这么做,这给其首席执行官瓦丝·纳拉西姆( Vas Narasimhan )带来了压力。Narasimhan 在与分析师的电话会议上表示,诺华(Novartis)在完成自己的调查之前(大约在药品获得批准后一个月),一直在等待向该机构通报数据操纵情况。FDA 和诺华(Novartis)都表示,相关数据并不涉及该药的安全性和有效性, Zolgensma 应该继续上市。 这位知情人士说,卡斯帕尔是少数几名因数据操纵而被解雇的科学家之一。他拒绝透露姓名,因为目前正在对这一情况进行调查。 这一事件引起了特别的关注,因为 Zolgensma 的价格标签:单治疗210万美元。它被认为是治疗脊髓性肌萎缩症的一个突破,这是一种罕见的毁灭性的儿童疾病。诺华(Novartis)去年以87亿美元收购了 AveXis 。FDA 威胁对该公司进行民事或刑事处罚。 卡卡斯帕的律师在声明中说,卡萨尔“自豪地支持药物的安全性和有效性,他和他的团队努力发展。”“他配合了 AveXis 的内部调查,并断然否认有任何不当行为。他准备维护自己的权利,并相应地捍卫自己的行为.卡斯帕博士继续祝愿临床医生和公司继续成功地治疗儿童的这种致命和毁灭性疾病。 卡斯帕的律师 Hueston 对公司的争议并不陌生:他在美国证券交易委员会( SecuritiesandExchangeCommission )有关马斯克推文的案件中为特斯拉首席执行官埃隆·马斯克( ElonMusk )辩护。2006年,在安然高管肯尼思•莱( Kenneth Lay )和杰弗里•斯基林( Jeffrey Skilling )的案件中,休斯敦也是首席检察官,两人都因证券和电信欺诈而被定罪。 Hueston 说,他不代表卡斯帕的兄弟 Allan ,他没有回应寻求评论的消息。

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