Novartis dismissed the top two scientists at its gene therapy division shortly after CEO Vas Narasimhan learned of internal data falsification that has since snowballed into a damaging scandal, a person familiar with the situation said Wednesday.
The company previously said it was “in the process of exiting” scientists who were responsible for the scandal but did not identify them. In a statement on Wednesday, Novartis said that it had appointed a new chief scientific officer for AveXis and that other scientists, Brian and Allan Kaspar, “have not been not been involved in any operations at AveXis since early May 2019,” without elaborating.
The person familiar with the situation, who spoke on condition of anonymity, confirmed that the departure of the Kaspars, who are brothers, was connected to the disclosure of data manipulation related to the gene therapy Zolgensma.
As stated by another commenter: Two contradictory statements back-to-back : “Had the agency known about the manipulation, it would have delayed the approval of Zolgensma, according to Dr. Wilson Bryan, the director of the FDA division that reviewed Novartis’s gene therapy.” Followed by : “Both Novartis and the FDA have said that the falsified data have no bearing on the safety or efficacy of the approved version of Zolgensma.”
The conclusion here is that one of the ancillary review teams within the FDA WOULD HAVE delayed this medicine from reaching patients based on something that “Has no bearing on the safety and efficacy of the approved version of Zolgensma.”
Let that sink in.
They would have rejected the application of a life-saving medication based on something that does NOT impact its safety and efficacy, had they only found out about in time. Unbelievable. This is part of what’s wrong with the new policy of “equality” within FDA teams during a drug review. Teams like this whose review work is important but does NOT impact safety and efficacy of the potential approved medicine should NOT have equal power to the more advanced and more important teams to stand in the way of innovative treatments!
Of course it would have delayed approval (and not necessarily led to “rejection” as you conclude). How long do you think it takes to determine that the data manipulations had “no bearing on the safety and efficacy of the approved version of Zolgensma.” It was determined after the fact of approval instead of before, and patients taking this drug were lucky that there was no other data manipulations discovered that could have affected safety and/or efficacy. The FDA should be given the freedom to do its job, especially in cases where data has been falsified.
Two contradictory statements back-to-back : “Had the agency known about the manipulation, it would have delayed the approval of Zolgensma, according to Dr. Wilson Bryan, the director of the FDA division that reviewed Novartis’s gene therapy.” Followed by : “Both Novartis and the FDA have said that the falsified data have no bearing on the safety or efficacy of the approved version of Zolgensma.” Conclusion to this simplicity: the FDA puts no value on actual data ……… ???? While this saga of deceipt and corruption plays out (someone definitely is in someone else’s pockets) Novartis is making millions, on falsified data. Only in America ??? This certainly reeks !
My guess is that the falsified data involved a process change, but the product resulting from the new process was used in clinical trials and demonstrated safety and efficacy. It still demonstrates that the sponsor must ensure the quality and integrity of the data that it submits. I was wondering if any heads closer to the falsification were going to roll. I have a feeling there may be more than two.
Until persuaded otherwise, I’d currently be more concerned about corruption within the Trump version of the FDA than within Novartis.
I never thought I’d say that. How low has the US govt sunk.