Novartis CEO admits mishandling Zolgensma crisis


2019-08-21 01:20:34 FiercePharma


Until recently, Novartis CEO Vas Narasimhan apparently navigated several scandals unscathed, at least personally. But the Zolgensma data manipulation debacle could be the first big, public mistake of his own making. Addressing 12,000 managers in a not-quite mea culpa—as he did in the wake of the $1.2 million Michael Cohen contract exposé—Narasimhan said he now sees where Novartis could have done a better job handling the Zolgensma crisis, Swiss newspaper Schweiz am Wochenende reported, according to Bloomberg. The words came in stark contrast to his “we did the best we could” comment in a call with analysts right after the news erupted. Now, he said he’s not perfect as a CEO, and “we will all keep working on it.” Novartis and its AveXis unit took heavy fire earlier this month when the FDA announced faked mouse data were included in the application package for the company's gene therapy Zolgensma. What’s worse for the company’s image, Novartis heard about the problem in mid-March and confirmed the allegations internally in early May, but waited weeks before alerting the FDA. By the time Novartis told the agency, it had been more than a month since the pricey spinal muscular atrophy therapy was approved. Narasimhan has rejected the idea that the delay had anything to do with the FDA's review timeline. Novartis was only trying to make sure it gave the FDA a clear picture of the problem, he said. But the company did replace AveXis' two top scientists in a purge of employees involved in the data irregularities. RELATED: Novartis' AveXis shifted top scientific leadership before Zolgensma data scandal erupted Just as the company works to appease the public uproar, a new revelation has raised eyebrows. A C-level exec sold CHF 925,400 ($944,300) worth of the company’s stock July 19, a filing to the Swiss exchange shows. That's the day after Novartis unveiled its second-quarter financial results and almost three weeks after the company informed the FDA of the data falsification—but before the Zolgensma problem became public. A spokesperson told FiercePharma: “As is usual in such cases, the transaction was thoroughly checked beforehand and then approved accordingly. The person in question was not in possession of relevant material information.” While the data breach might not affect Zolgensma’s approval—the FDA has said the key human clinical data were intact—the agency did say it was considering criminal and civil penalties against the company. It referred the case to the Office of Criminal Investigations for evaluation, The Wall Street Journal reported, citing one person familiar with the matter. RELATED: Senate panel launches probe into Novartis' 'reprehensible' response to Zolgensma data irregularities The furor in Washington is also pronounced. A team of five U.S. lawmakers, including Sens. Bernie Sanders and Elizabeth Warren, blasted Novartis for the data manipulation and failure to quickly reveal it to the FDA. Senate Finance Committee chair Chuck Grassley, calling Novartis’ conduct “reprehensible,” has launched an investigation. He demands a detailed timeline of the development and all records relating to its in-house inquiry. The Novartis spokesperson confirmed the company has received the letter and is planning to respond. Wednesday, AveXis said its former chief scientific officer, Brian Kaspar, and his brother, Allan Kaspar, then-senior vice president of R&D, stopped working at the company in early May when the internal probe first confirmed the data falsification. The two scientists were replaced by Page Bouchard on Aug. 5, AveXis said.
直到最近,诺华(Novartis)首席执行官 VasNarasimhan 显然还没发现几起丑闻,至少是个人丑闻。但 Zolgensma 数据操纵丑闻可能是他自己犯下的第一个重大公共错误。 据彭博社( Bloomberg )报道, Narasimhan 说,他现在看到诺华(Novartis)公司在应对佐尔森玛危机方面可以做得更好,就像他在迈克尔•科恩( Michael Cohen )价值120万美元的合同曝光后所做的那样。 这些话与他在新闻爆出后与分析师的一次电话会议上发表的“我们尽了最大努力”截然不同。现在,他表示,作为首席执行官,他并不完美,“我们将继续努力。” 本月早些时候,诺华(Novartis)及其旗下的 AveXis 公司遭受了重击, FDA 宣布将伪造的老鼠数据纳入该公司基因治疗佐尔格森玛的应用程序包。更糟糕的是,诺华(Novartis)公司在3月中旬听说了这个问题,并在5月初在内部证实了这些指控,但几周后才通知 FDA 。当诺华(Novartis)告诉该机构,自从昂贵的脊柱肌肉萎缩治疗被批准以来已经超过一个月了。 Narasimhan 拒绝了这样的观点,即延迟与 FDA 的审查时间表有任何关系。他说,诺华(Novartis)公司只是想让 FDA 清楚地了解这个问题。但该公司确实更换了 AveXis 公司的两名顶尖科学家,以清除参与数据违规的员工。 相关报道:诺华(Novartis)公司的 AveXis 在 Zolgensma 数据丑闻爆发之前改变了最高的科学领导地位 正如该公司努力平息公众的不满一样,一项新的发现也引起了人们的不满。向瑞士交易所提交的文件显示,一名 C 级高管7月19日卖出了价值925400瑞士法郎(合944300美元)的该公司股票。就在这一天,诺华(Novartis)公布了第二季度的财务业绩,并在公司向 FDA 报告数据造假的将近三周后——但在 Zolgensma 问题公开之前。 一位发言人对 FiercePharma 表示:“在这种情况下,通常会事先对交易进行彻底检查,然后相应批准。有关人员没有掌握相关的材料信息。” 尽管数据泄露可能不会影响 Zolgensma 的批准—— FDA 已经表示关键的人体临床数据是完整的—— FDA 确实表示正在考虑对该公司进行刑事和民事处罚。据《华尔街日报》报道,该报援引一位知情人士的话,将此案提交刑事调查办公室进行评估。 相关报道:参议院小组对诺华(Novartis)对佐尔甘马数据违规的“应受谴责”反应展开调查 华盛顿的愤怒也是明显的。一个由五名美国议员组成的小组,包括 Sense 。Bernie Sanders 和 Elizabeth Warren 指责诺华(Novartis)操纵数据,未能迅速向 FDA 披露。参议院财务委员会主席查克•格拉斯利( Chuck Grassley )称,诺华(Novartis)的行为“应受到谴责”,并发起了一项调查。他要求提供详细的发展时间表和与内部调查有关的所有记录。 诺华(Novartis)发言人证实,该公司已收到这封信,并计划作出回应。 周三, AveXis 表示,当内部调查首次证实数据造假时,该公司前首席科学官布赖恩·卡斯帕( Brian Kaspar )和他的哥哥艾伦·卡斯帕( Allan Kaspar )于5月初停止了在该公司工作。AveXis 说,这两位科学家在8月5日被 Page Bouchard 取代。