Deciding Vote in FDA Advisory Committee Recommendation to Remove Black Box Warning for Chantix is Cast by Pharmaceutical Company President; FDA Review Process is Badly Tainted

Last Wednesday, a pair of FDA advisory committees - meeting jointly -voted 10-9 to recommend that the FDA remove the black box warning for Chantix (varenicline). Currently, the black box warns about the potential for severe psychiatric side effects of Chantix, including depression and suicidal ideation. The recommendation is not binding, and the FDA is free to follow or ignore the advisory panel ' s vote.According to anarticle atMedPage Today: " a few of those who voted to remove the warning said the study supplied the evidence needed to make them comfortable using Varenicline to address a major public health problem. ' The risk-benefit ratio is as clear as anything I have ever seen, ' said David Pickar, MD, a Johns Hopkins Medical School psychiatry professor who said he works with psychiatric patients. Looking at his fellow committee members, Pickar added: ' For you, these are adverse events, but the benefit to these patients could be substantial in the most fundamental thing, which is being alive. ' "The Rest of the StoryWhat this article and similar ones are not telling you is that the advisory committee member mentioned above - who cast the deciding vote - is, believe it or not, the president of a pharmaceutical company!In a whopping conflict of interest that is apparently not disclosed in the article, it turns out that Dr. Pickar, according to his ownweb site, is " Founder and President of Gabriel Sciences, a company whose mission is advancing the development of a novel...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs