Too Fast or Not Too Fast: The FDA's Approval of Merck's HPV Vaccine Gardasil
Too Fast or Not Too Fast: The FDA's Approval of Merck's HPV Vaccine Gardasil
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DOI：
10.1111/j.1748-720x.2012.00698.x
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发表时间：
2012-09-01
影响因子：
2.1
通讯作者：
Shaw, Christopher A.
中科院分区：
文献类型：
--
作者：
Tomljenovic, Lucija;Shaw, Christopher A.
没有多少公共卫生问题的观点像疫苗一样极端两极分化，默克公司的HPV疫苗Gardasil就是一个很好的例子。自2006年获得FDA批准以来，默克公司一直因其过于激进的营销策略和旨在将Gardasil作为强制性疫苗推广的游说活动而受到严厉批评。随后，人们提出了这样的问题：当疫苗生产商的利益冲突如此明显时，他们参与公共卫生政策是否合适。他们的一些广告宣传口号，如宫颈癌每年杀死x名妇女，你的女儿可能会少一个受宫颈癌影响的生命，似乎更多地是为了促进恐惧，而不是基于证据的关于疫苗潜在益处的决策。虽然利益冲突并不一定意味着产品本身有缺陷，但应根据事实科学数据仔细审查营销主张。目前，美国和其他卫生当局强烈建议接种Gardasil疫苗，而公众对疫苗安全性和有效性的担忧似乎正在增加。这种差异导致了一些需要解决的重要问题。目前的审查审查的关键问题，这场辩论的光，目前可用的研究证据。
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.