Data manipulation allegations continue to haunt drug giant Novartis which recently decided to pull out two scientists occupying leading positions at AveXis.
Hit the core
AveXis is the Novartis subsidiary at the center of a huge controversy related to data manipulation. Now, the company has removed scientist brothers Brian Kaspar and Allan Kaspar from their posts. Brian worked as Scientific Director while Allan was Vice President of R&D for the company. The company noted in a statement that the two brothers
“I have not participated in any operation at AveXis since early May 2019 and am no longer with the company.”
The company did not provide details on why the two were fired. However, the problem could be related to their new Zolgensma gene therapy. 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 list price of $ 2.1 million. It became the most expensive drug in the world, but not before the USFDA asked questions about the product. Things quickly started to deteriorate in the company. The Food and Drug Administration alleged,
“After the product was approved by the FDA, the agency was made aware by AveXis Inc., the manufacturer of the product, of a data manipulation issue that affects the accuracy of some data from testing. products made on animals submitted in the Biologics License Application (BLA) and reviewed by the FDA.
Novartis is in trouble
When you connect the dots, it becomes obvious why the company ditched its top two talents and specifically mentioned that they weren’t associated with the company since May. CEO Vas Narasimhan also hinted at the possible exit of affected employees from the company last week while noting that they have started investigating the matter.
The FDA has not ordered the company to take Zolgensma off the shelves, and Novartis has consistently pointed this out in its statements. However, this does not remove the possibility of civil or even criminal action against the company for its exercise of data manipulation.
Meanwhile, political campaigns have already started targeting Novartis. Democratic Sen. Bernie Sanders and Elizabeth Warren both sent letters to Ned Sharpless, the acting commissioner of the FDA to hold the company accountable. They also asked him to take civil, criminal and regulatory actions against the company. The two talked about creating the priority for a pharmaceutical company.