Novartis' Zolgensma data rigging draws Senators' ire

诺华公司( Novartis )旗下的佐尔甘马( Zolgensma )数据造假引起了参议员们的不满

2019-08-12 16:02:00 pharma


U.S. Sens. Bernie Sanders and Elizabeth Warren have been harsh critics of the pharmaceutical industry in general. Now they've joined hands with three other senators to go after one pharma company in particular. In a letter to the FDA, five Democrats, led by Sen. Richard Durbin of Illinois, blasted Novartis and its AveXis unit for submitting—and failing to quickly disclose—manipulated data that helped its $2.1 million spinal muscular atrophy gene therapy Zolgensma win an FDA approval. They're not just looking for a public scolding. They're calling on the FDA to throw the book at the Swiss drugmaker and the gene therapy unit it bought last year. And their criticism could well lead the FDA to revive a data-disclosure rule it nixed in October. “We urge you to use your full authorities to hold AveXis accountable for its malfeasance, including through all appropriate criminal, civil, and regulatory actions against the company,” the senators wrote in a letter (PDF) addressed to FDA’s acting commissioner, Ned Sharpless. “Anything short of a forceful response would signal a green light to future pharmaceutical misbehavior.” The FDA last week revealed that Novartis had used falsified animal testing data in its Zolgensma drug application package. While the senators criticized the submission itself as “unconscionable,” they also took issue with Novartis’ disclosure timeline. By Novartis’ account, it became aware of the data problem in March and confirmed the allegation internally in early May, ahead of Zolgensma’s approval on May 24. But the company didn’t inform the FDA until June 28, after it completed an internal investigation. RELATED: Novartis CEO: 'We did the best we could' in Zolgensma data manipulation probe Meanwhile, the five senators are also calling on Sharpless to explain why the FDA decided in October 2018 to withdraw a regulation that would have required drugmakers to promptly report suspected falsified data, and whether the FDA plans to reinstate it in the wake of the AveXis case. In a conference call with investors, Novartis CEO Vas Narasimhan denied the delay had anything to do with the timing of the FDA review. After confirming the allegations from an internal whistleblower in May, the company had also gone on to find out more details before handing the FDA the “technical assessment,” he said. Novartis “tried to do all of the right things,” Narasimhan said. However, the senators characterized the drugmaker’s lag in communication as “knowingly misleading the FDA in a rush to make a profit.” The bad data were so far only linked to mouse assays used only for initial product testing, not for commercial product release, Novartis has said. The FDA agreed with Novartis that Zolgensma should stay on the market given the evidence around the drugs’ effectiveness and safety profile in human clinical trials. However, the agency has also said it takes “the integrity of the product testing data […] very seriously.” As such, the FDA said it’s considering possible civil or criminal penalties against Novartis. RELATED: Pharma back in hot seat as 2020 presidential election gets into gear Sanders and Warren are both outspoken critics of the drug industry. In December, Warren and Rep. Jan Schakowsky introduced bills that aim to lower drug prices by asking the federal government to manufacture generic drugs. That proposal came shortly after Sanders introduced his own Prescription Drug Price Relief Act that would tie U.S. drug prices to those from other developed countries. Warren recently went after former FDA commissioner Scott Gottlieb’s transition to Pfizer’s board, saying the move “smacks of corruption.” And Sanders just paired with Rep. Elijah Cummings in asking the Department of Justice to prioritize a generic drug price-fixing investigation. Novartis itself has been embroiled in several reputational crises lately, including bribery and doctor kickback allegations in several countries, including the U.S. Not to mention the payment to President Donald Trump’s former personal lawyer Michael Cohen, which hit headlines even outside of the life sciences world. Since Narasimhan took over the CEO job, he has made rebuilding trust with society a top priority at Novartis. “It’s a long, long road and sometimes it’s bumpy,” he acknowledged during the Zolgensma call.
美国的感觉.Bernie Sanders 和 Elizabeth Warren 对整个制药行业都提出了严厉的批评。现在他们已经和其他三位参议员一起去寻找一家制药公司。 在给 FDA 的一封信中,5名民主党人,由参议员领导。伊利诺斯州的理查德·杜宾( RichardDurbin )猛烈抨击诺华(Novartis)及其旗下的 AveXis 部门提交了——但未能迅速披露——操纵数据,帮助其210万美元的脊髓性肌萎缩症基因疗法 Zolgensma 获得 FDA 批准。 他们不仅仅是在寻求公开谴责。他们呼吁美国食品和药物管理局把这本书扔给瑞士制药商和去年购买的基因治疗部门。他们的批评很有可能导致 FDA 重启10月份废除的数据披露规则。 这些参议员在给 FDA 代理专员 Ned Sharpless 的一封信( PDF )中写道:“我们敦促你利用你的全部权力,追究 AveXi 公司的不当行为,包括采取所有适当的刑事、民事和监管行动。”“任何缺乏强有力反应的事情都将预示着未来制药不当行为的绿灯。” FDA 上周透露,诺华(Novartis)公司在其 Zolgensma 药物应用程序包中使用了伪造的动物检测数据。尽管两位参议员批评该提案本身“不合理”,但他们也对诺华(Novartis)的披露时间表提出了质疑。 根据诺华(Novartis)的说法,该公司在3月就意识到了数据问题,并在5月初在佐尔甘斯曼5月24日批准之前,在内部证实了上述指控。但该公司在完成内部调查后,直到6月28日才通知 FDA 。 相关报道:诺华(Novartis)公司首席执行官:在佐尔甘马数据操纵调查中,我们尽了最大努力 与此同时,这五位参议员还呼吁夏普勒斯解释,为什么 FDA 在2018年10月决定撤销一项要求制药商及时报告可疑伪造数据的规定,以及 FDA 是否计划在 AveXis 案之后恢复这项规定。 在与投资者的电话会议上,诺华(Novartis)首席执行官 VasNarasimhan 否认延迟与 FDA 审查的时间有关。他说,在5月份确认了一名内部举报人的指控后,该公司还在向 FDA 提交“技术评估”之前,找到了更多细节。 诺华(Novartis)“试图做所有正确的事情,” Narasimhan 说。然而,这些参议员将制药商在沟通上的滞后描述为“故意误导 FDA ,以求获利”。 诺华(Novartis)表示,到目前为止,这些坏数据只与鼠标法有关,而不是用于商业产品的发布。 FDA 同意诺华(Novartis)公司的观点,鉴于该药在人体临床试验中的有效性和安全性方面的证据, Zolgensma 应该继续留在市场上。然而,该机构还表示,它非常认真地对待“产品测试数据的完整性”。因此, FDA 表示正在考虑对诺华(Novartis)进行民事或刑事处罚。 相关报道:医药行业在2020年总统大选开始之际重新进入热门位置 桑德斯和沃伦都是制药业的直言不讳的批评者。12月,沃伦和众议员。JanSchakowsky 提出法案,要求联邦政府生产仿制药,以降低药品价格。就在桑德斯提出自己的处方药价格减免法案后不久,这一提议将把美国的药价与其他发达国家的药价挂钩。 沃伦最近追随 FDA 前专员斯科特·戈特利布( Scott Gottlieb )向辉瑞(Pfizer)董事会的转变,称此举“带有腐败的味道”。桑德斯刚刚和众议员搭档。Elijah Cummings 要求司法部优先进行仿制药定价调查。 最近,诺华(Novartis)本身卷入了几场声誉危机,包括多个国家的贿赂和医生回扣指控,其中包括美国。更不用说,支付给唐纳德·特朗普总统的前私人律师迈克尔·科恩( Michael Cohen )的费用,后者甚至在生命科学领域之外也登上了头条新闻。 自从 Narasimhan 接任首席执行官以来,他已经把重建与社会的信任作为诺华(Novartis)的首要任务。“这是一条漫长的道路,有时是颠簸的,”他在佐尔格森玛电话中承认。