A former GlaxoSmithKline (GSK) employee who handled statistics for clinical studies has filed suit against the life sciences giant. The whistleblower suit was filed in New Jersey, contending the employee was fired for speaking out about unreliable study results that have underpinned the deceptive marketing of a smoking cessation product. Alexandre Selmani, who served as one of GSK’s managers of biostatistics for smoking reduction and cessation, accuses the company of illegal and deceptive marketing of NiQuitin oral strips as an advanced and superior treatment method for one-time smokers looking to kick the habit. It’s alleged that GSK has acted under false pretenses based on the results of studies that were marred by mistakes. The complaint said:
Selmani’s objections to and refusal to ratify the studies based on the statistical analysis and the publication of same that was incorrect (which he reasonably believed was in violation of GSK policies and a perpetration of fraud on the public) was the motivating factor for GSK’s retaliatory action against Selmani.
Selmani complained about mistakes with the statistical methodology of studies involving NiQuitin and other products starting in December 2012, and he says GSK retaliated against him with lower performance ratings, lower salary increases, sabotaged work and ultimately his termination in in October. It appears he was fired as a result of his calling out mistakes that were being made for NiQuitin oral strips and other products.
The whistleblower in this case was trying to protect ultimately the consumers from buying products that were fraudulently advertised because the studies that proved their effectiveness were flawed.
Selmani is suing GSK under New Jersey’s Conscientious Employee Protection Act. He also names several individuals with the company as Defendants, including Mitchell Kotler, who was the director of biostatistics and Selmani’s direct manager; GSK CEO Andrew Witty; Liam Kennedy, GSK’s head of biostatistics; and Emma Walmsley, the CEO of GSK Consumer Healthcare. A spokeswoman for the company declined comment on Wednesday. The following is alleged in the complaint:
GSK hired Selmani in 2006, and he saw a steady stream of positive performance evaluations and salary increases until his whistleblowing activities began in 2012, according to the complaint. That year, Selmani discovered numerous mistakes that undercut the quality of studies that were part of a so-called smokers health project that Kolter was conducting. Nothing was done to correct the mistakes after Selmani approached Kolter and a vice president with his concerns. However, Selmani contends that he didn’t drop the issue. In 2013, he sent an email to Witty regarding mistakes in the studies “which had the capacity to cause negative consequences and potential health and safety issues for the general public.”
However, Selmani’s concerns were ignored and the studies were made public the following year, the complaint said. Those activities and other alleged whistleblowing surrounding study problems were met with comments from Kolter such as “your future is not with GSK” and attempted interference with his work, according to the complaint. In 2015, Kolter handed Selmani a performance review with the lowest possible score, which was followed by Selmani’s termination later that year. There was no reason offered for that termination.
Selmani is represented by Natalie A. Zammitti Shaw and Rosemarie Arnold of the Law Offices of Rosemarie Arnold. The case is in the Superior Court of New Jersey, Morris County.
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