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Whistleblower Lawsuit Filed Over Nicoderm Study Concerns

Whistleblower Lawsuit Filed Over Nicoderm Study Concerns

January 12, 2016 — A former employee of GlaxoSmithKline (GSK) has filed a lawsuit claiming he was fired in retaliation for raising concerns about the integrity of a study used to promote Nicoderm smoking-cessation products, Bloomberg reports.

The whistleblower, Alexandre Selmani, took issue with two clinical trials involving NiQuitin, a dissolving oral nicotine strip made by GSK. Participants in the the studies were randomly given either a 2.5-mg strip of NiQuitin or a 2-mg nicotine lozenge.

Perhaps not surprisingly, researchers found that NiQuitin was more effective at stopping cravings within 50 seconds than the lozenge. Selmani called the study deceptive and flawed because researchers improperly considered the two doses bioequivalent. According to the lawsuit (PDF):

“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.”

Despite raising concerns, uncorrected results of the study were published by Psychopharmacology in April 2014.

Selmani said he raised concerns to his immediate supervisors, but they refused to correct the errors. He then sent an email directly to the CEO of the company, warning that miscalculations in the study could “cause negative consequences and potential health and safety issues for the general public.”

Soon afterward, he was given the lowest possible score on a performance review and fired from his $134,000 per year job, according to Law360. The lawsuit was filed in January 6 in the New Jersey Superior Court, Case No. MRS L-2995-15.

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