Ex-GlaxoSmithKline Biostatistician Sues, Claims He was Let Go Over Nicoderm Studies

Published: Jan 13, 2016

Ex-GlaxoSmithKline Biostatistician Sues, Claims He was Let Go Over Nicoderm Studies
January 13, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Alexandre Selmani, a former biostatistics manager for London-based GlaxoSmithKline , recently filed a whistleblower lawsuit against the company regarding his firing for questioning statistical data for its clinical trials for its smoking-cessation products.

Selmani filed the lawsuit over his subsequent termination in Morris County Superior Court in New Jersey. The suit argues that he received “stellar reviews” and good bonuses from when he was hired in 2006 until December 2012, when he started trying to bring attention to statistical problems in the studies involving the company’s smoking reduction and cessation products.

The products are NiQuitin, which is marketed in the U.S. as Nicoderm. In mid-2012, Selmani brought the problems to the attention of his supervisor, who apparently ignored him. He then went on to send emails to others in the company regarding the problems, including to Andrew Witty, the company’s chief executive officer. According to the lawsuit, Selmani’s emails warned that the statistical errors had “the capacity to cause negative consequences and potential health and safety issues for the general public.”

The study Selmani had issues with was eventually published online in Psychopharmacology in April 2014.

Selmani’s lawsuit cites that his supervisors retaliated by writing low job performance reviews and decreasing raises, sabotaging some of this work, and eventually firing him in October 2015.

“The company wanted to use flawed data to sell the product to the public,” said Rosemarie Arnold, Selmani’s attorney, to Pharmalot. “And when he brought that to the attention of his supervisor, he was basically told to shut up. He worked there many years, got great reviews, and did a great job. But they tried to push him out when he complained they used improper data. And consumers paid for something they didn’t get.”

A GSK spokeswoman, Pamela McKinlay, told CNB that as of last Friday it had not received a summons. “We stand fully behind Nicoderm as a safe and effective form of smoking cessation which continues to help people to quit. GSK also goes to great lengths to promote ethics and compliance in the workplace and has mandatory training to ensure all of our employees adhere to the highest standards of integrity.”

Among other issues raised in the lawsuit, Selmani claims that he found “numerous mistakes” in a Smokers’ Health Project that his manager was running, which made the results of studies comparing a nicotine patch and film unreliable. According to the suit, when Selmani brought the errors to his bosses’ attention, he was criticized for the way he made the claims. Allegedly, his manager told him, “I am free to decide, say or write whatever I want. I’m not going to listen to you.”

“Rather than fix the mistakes in the studies so as not to mislead the public about the effectiveness of their product, they fired the person who discovered it,” said Arnold to CNBC. “I believe they did that because they wanted him to shut his mouth, and they didn’t want the mistakes in the study to become known. It would have undercut the value of the product in the consumer’s mind.”

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