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

Tomljenovic LShaw CA.

Early career postdoctoral fellow in the Neural Dynamics Research Group at the University of British Columbia. Professor in the Department of Ophthalmology and Visual Sciences at the University of British Columbia and holds cross appointments with the Program in Experimental Medicine and the Graduate Program in Neuroscience.

Abstract

There are not many public health issues where views are as extremely polarized as those concerning vaccines, and Merck’s HPV vaccine Gardasil is a case in point. Ever since gaining the FDA’s approval in 2006, Merck has been heavily criticized for their overly aggressive marketing strategies and lobbying campaigns aimed at promoting Gardasil as a mandatory vaccine. Subsequently, questions have been raised as to whether it was appropriate for vaccine manufacturers to partake in public health policies when their conflicts of interests are 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. Although, conflicts of interests do not necessarily mean that the product itself is faulty, marketing claims should be carefully examined against factual science data. Currently Gardasil vaccination is strongly recommended by the U.S. and other health authorities while public concerns about safety and efficacy of the vaccine appear to be increasing. This discrepancy leads to some important questions that need to be resolved. The current review examines key issues of this debate in light of currently available research evidence.

© 2012 American Society of Law, Medicine & Ethics, Inc.

PMID:  23061593
[PubMed - in process]

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