Whistleblower Fired After Raising Nicoderm Study Concerns

January 12, 2016 — GlaxoSmithKline (GSK) has been hit with a lawsuit by a former employee who blew the whistle on flawed studies that were used to promote Nicoderm smoking-cessation products.

Bloomberg reports that the whistleblower lawsuit (PDF) was filed by Alexandre Selmani, a scientist who was hired by GSK in 2006 to oversee study designs as a manager of biostatistics.

In 2012, he said he discovered mistakes in two studies that were used to promote NiQuitin, an oral soluble nicotine film. Patients in the study were randomly given either a 2.5-mg dose of nicotine film (NiQuitin) or a 2-mg dose of nicotine lozenges.

The studies concluded that NiQuitin relieved cravings faster than nicotine lozenges or gum, and results were published in Psychopharmacology in April 2014.

Selmani says researchers mistakenly considered the products equivalent, despite the obvious difference in nicotine dosage. He also took issue with “deceptive” statistical analyses. According to the lawsuit complaint:

“GSK engaged in an illegal, deceptive [marketing] program worldwide to promote the use of NiQuitin, asserting without justification that NiQuitin was superior to existing nicotine treatment.”

When his immediate supervisors refused to make corrections to the errors, Selmani sent an email directly to the company’s CEO, warning that the study miscalculations have the “capacity to cause negative consequences and potential health and safety issues for the general public.”

Selmani accuses his managers of firing him in retaliation, violating state laws protecting whistleblowers who expose fraud and other wrongdoings. The lawsuit was flied in New Jersey Superior Court on January 6, Case No. MRS L-2995-15.

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