Pfizer Study of Psychiatric Risks of Chantix Marred by Financial Conflicts of Interest and Under-Reporting of Adverse Events

According to abriefing document for today ' s joint meeting of the FDA ' s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the black box warning for Chantix (varenicline), Pfizer ' s study of the potential serious psychiatric side effects of Chantix, which reported no significant increased risk of adverse events, was marred by financial conflicts of interests of many of the study investigators and by under-reporting of adverse events, including potential episodes of suicidal ideation and depression that could have been drug-related.According to the document, investigators at 32 of the 139 study sites had a financial conflict of interest by virtue of having received more than $25,000 in the past five years in speaking fees related to the promotion of Chantix or other Pfizer products. Moreover, at the sites with financially conflicted investigators, the reporting of adverse drug events was substantially lower than at non-conflicted sites. For example, while the rate of adverse neuropsychiatric events was 6.4% at non-conflicted sites, the rate was only 1.8% at sites at which an investigator had a conflict of interest.In some cases, the under-reporting of adverse events seems quite blatant. For example, the document cites one patient, who was coded asnot having an adverse neuropsychiatric event, as having reported: " I think I am having a major depression. I am worried. I cry easily. I have apathy, I have no desire to...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs