Data manipulation allegations are continuing to haunt drug giant Novartis which recently decided to axe two scientists holding top positions at AveXis.
Striking the core
AveXis is the Novartis subsidiary in the center of a huge controversy related to data manipulation. Now, the company has removed brother scientists Brian Kaspar and Allan Kaspar from their positions. Brian was working as the chief scientific officer while Allan was the R&D VP at the company. The company noted in a statement that the two brothers
“have not been involved in any operations at AveXis since early May 2019 and are no longer with the company.”
The company did not provide any specifics into why the two were let go of. However, the issue could be related to their new gene therapy Zolgensma. The therapy is used for the treatment of an extremely rare disease called spinal muscular atrophy (SMA).
Zolgensma was approved in May and came with a $2.1 million list price. It became the most expensive drug in the world but not before the USFDA posed questions about the product. Things quickly started going downhill at the company. The Food and Drug Administration alleged,
“following the FDA’s approval of the product, the agency was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA) and reviewed by the FDA.”
Novartis is in trouble
When you connect the dots, it becomes evident why the company let go of its two top talents and specifically mentioned that they were not associated with the company since May. CEO Vas Narasimhan also hinted at the possible exit of relevant employees from the firm last week while noting that they have started investigating the issue.
The FDA did not order the company to take Zolgensma off the shelf, and Novartis has constantly highlighted this thing in its statements. However, this doesn’t remove the possibility of a civil or even criminal action against the company for their data manipulation exercise.
Meanwhile, political campaigns have already started targeting Novartis. Democratic senator Bernie Sanders and Elizabeth Warren have both sent letters to Ned Sharpless, the acting FDA commissioner to hold the company accountable. They also asked him to take civil, criminal and regulatory actions against the firm. Both have talked about setting the precedence for a pharmaceutical company.
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