Too Fast or Not Too Fast: The FDA's Approval of Merck's HPV Vaccine Gardasil

Abstract

There are not many public health issues where views are as extremely polarized as those concerning vaccination policies. Ever since its Fast Track approval by the U.S. Food and Drug Administration (FDA) in 2006, Merck's human papilloma virus (HPV) vaccine Gardasil has been sparking controversy. Initially, the criticism has been focused at Merck, due to their overly aggressive marketing strategies and lobbying campaigns. According to a 2007 editorial in Nature Biotechnology, Surrounded by a chorus of disapproval, Merck cracked. As Nature Biotechnology went to press, the company announced a cessation of all efforts to lobby for US state laws requiring compulsory vaccination. Subsequently, questions have been raised whether it was appropriate for vaccine manufacturers to partake in public health policies when their conflicts of interests were so obvious. Some of their advertising campaign slogans, such as cervical cancer kills x women per year and your daughter could become one less life affected by cervical cancer, seemed more designed to promote fear rather than evidence-based decision making about the potential benefits of the vaccine versus any risks.