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FDA probing ‘data manipulation’ from early tests of Novartis drug

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The Novartis (NVS) scientist who was ousted by the drug maker in connection with a scandal over data manipulation broke his silence late Monday, saying through a lawyer that he categorically denied any wrongdoing and was “prepared to assert his rights and defend his conduct accordingly.”

The researcher, Brian Kaspar, was dismissed from the company, along with his brother, Allan. Both were leading scientists at AveXis, which developed the gene therapy Zolgensma and which was later acquired by Novartis. The Food and Drug Administration earlier this month accused the drug maker of falsifying preclinical data related to its application for approval of the treatment.

In his statement, Brian Kaspar said he “stands proudly behind the safety and efficacy of the drug.”

Novartis has been under fire over the revelation that there were issues related to a test in mice used to measure the therapy’s potency.

In a memo on Aug. 6, an FDA official said Novartis appeared to have been aware of allegations of data manipulation since March 14, but did not tell the FDA before Zolgensma was approved on May 24. After conducting a two-part investigation, Novartis told the FDA of the issues on June 28.

The FDA has said it “remains confident that Zolgensma should remain on the market.” But the agency’s acting commissioner, Ned Sharpless, publicly chided Novartis for the oversight. “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 authorities to take action, if appropriate, which may include civil or criminal penalties.”

The issue has attracted notice on Capitol Hill, with a group of lawmakers led by Sen. Dick Durbin (D-Ill.) urging Sharpless to “use your full authorities to hold AveXis accountable for its malfeasance, including through all appropriate criminal, civil, and regulatory actions against the company.”

In an email, a representative of John C. Hueston, a partner at Hueston Hannigan, a trial law firm that says it handles matters for Tesla, Amazon (AMZN), and Qualcomm, said that Hueston is representing Brian Kaspar. On its website, Hueston Hannigan calls boasts of its “disruptive trial lawyers” and says it is “a force to be reckoned with.”

The statement said Brian Kaspar “has cooperated with Avexis’s internal investigation.”

He “continues to wish the clinicians and the company continued success in the treatment of children with this deadly and devastating disease,” it added.

Scientist denies wrongdoing in Novartis data manipulation scandal
 




Watch out for data manipulation with Brolocizumab. Chances are good they’ll spin it and cherry pick it to get the results they will need coming into the retina market. C Sims is a snake in the grass who can’t be trusted
 




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