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

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Sep 012013

Lucija Tomljenovic and Christopher A. Shaw
Fall 2012, Journal of Law, Medicine & Ethics

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,1 “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,”2 seemed more designed to promote fear rather than evidence-based decision making about the potential benefits of the vaccine versus any risks. 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.

The HPV Vaccine Debate

In June 2006 the U.S. Food and Drug Administration (FDA) approved Gardasil, the first vaccine against the human papilloma virus (HPV).3 The quadrivalent vaccine targeting four common HPV strains (6, 11, 16 and 18) was the first pharmaceutical product specifically developed to protect against cervical cancer.4 Five years later, Gardasil became a key topic in the U.S. 2011 Republican presidential debate when Congresswoman Michelle Bachmann criticized Texas Governor Rick Perry over his prior executive order to make the vaccine mandatory.5 Bachmann later expressed serious concerns about the safety of the vaccine which added even more heat to the already controversial subject.
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