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TThe Novartis scientist (NVS), ousted by the drug maker as a result of a data manipulation scandal, broke his silence last Monday, stating through an attorney that He categorically denied any wrongdoing and was "ready to assert his rights and defend his behavior accordingly". "
The researcher, Brian Kaspar, was fired from the company with his brother, Allan. Both were leading scientists at AveXis, who developed Zolgensma gene therapy and was later acquired by Novartis. Earlier this month, the Food and Drug Administration accused the drug maker of falsifying the preclinical data related to its treatment approval request.
In his statement, Brian Kaspar said he "stands proudly behind the safety and effectiveness of the drug."
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Novartis was targeted by the discovery of problems with a mouse test used to measure the effectiveness of the therapy.
In an August 6 note, an FDA official said Novartis appeared to be aware of the data manipulation allegations since March 14, but had not informed it before Zolgensma's approval on May 24. . After a two-part investigation, Novartis informed the FDA of the problems on June 28th.
The FDA said "to remain convinced that Zolgensma should remain on the market". But agency commissioner Ned Sharpless has publicly criticized Novartis for overseeing it. "We rely on truthful scientific data to make regulatory decisions and we take the issue of data integrity very seriously," Sharpless tweeted. "In this case, the agency will use its full authority to take, if necessary, measures that may include civil or criminal penalties."
The issue drew attention to Capitol Hill, with a group of legislators led by Senator Dick Durbin (D-Ill.) Urging Sharpless to "use your full powers to hold AveXis accountable for its misdeeds, including by through all appropriate criminal, civil, civil and civil proceedings. and regulatory actions against the company. "
In an e-mail, a representative of John C. Hueston, a partner at Hueston Hannigan, a litigation law firm that says he manages business for Tesla, Amazon (AMZN), and Qualcomm, said Hueston represented Brian Kaspar. Hueston Hannigan boasts of his "disruptive trial lawyers" on his website and says it's "a force to be reckoned with."
According to the statement, Brian Kaspar "cooperated with the internal investigation of Avexis".
He "continues to wish clinicians and society continued success in treating children with this deadly and devastating disease," adds the text.
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