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Healthy Skepticism Library item: 14624

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Silverman E.
Merck’s Gardasil Should Not Be Mandatory: Report
Pharmalot 2008 Nov 11
http://www.pharmalot.com/2008/11/mercks-gardasil-should-not-be-mandatory/#more-17513


Full text:

A trio of academics is joining the debate over the notion requiring girls to be vaccinated with Merck’s Gardasil is not a good idea. And in a recent issue of the Journal of Law, Medicine & Ethics, Gail Javitt of Johns Hopkins’s Berman Institute of Bioethics, Deena Berkowitz of George Washington University School of Medicine and Lawrence Gostin of Georgetown University Law Center offer five reasons….
The long-term safety and effectiveness is unknown; historical justifications for mandated vaccination have not been met; in the absence of historical justification, the government risks public backlash by mandating vaccination; mandatory vaccination for girls – and not boys – may violate constitutional principles of equality and due process; and there are unresolved economic concerns over Gardasil’s cost and insurance coverage. They go on to write…
“While the emergence of an HPV vaccine reflects a potentially significant public health advance, the vaccine raises several concerns. First, the long-term safety and effectiveness of the vaccine are unclear, and serious adverse events reported shortly after the vaccine’s approval raise questions about its short-term safety as well. In light of unanswered safety questions, the vaccine should be rolled out slowly, with risks carefully balanced against benefits in individual cases. Second, the legal and ethical justifications that have historically supported state-mandated vaccination do not support mandating HPV vaccine.
“Specifically, HPV does not threaten an imminent and significant risk to the health of others. Mandating HPV would therefore constitute an expansion of the state’s authority to interfere with individual and parental autonomy.
“Engaging in such expansion in the absence of robust public discussion runs the risk of creating a public backlash that may undermine the goal of widespread HPV vaccine coverage and lead to public distrust of established childhood vaccine programs for other diseases. Third, the current sex-based HPV vaccination mandates present constitutional concerns because they require only girls to be vaccinated. Such concerns could lead to costly and protracted legal challenges.
“Finally, vaccination mandates will place economic burdens on federal and state governments and individual practitioners that may have a negative impact on the provision of other health services. In light of these potentially adverse public health, economic, and societal consequences, we believe that it is premature for states to add HPV to the list of state-mandated vaccines.”
Meanwhile, you may recall that the Centers for Disease Control and Prevention last month declared that Gardasil is not likely the cause of numerous adverse events. The CDC look-see followed disclosures twice last year by Judicial Watch, a conservative group, about side-effect reports showing thousands of adverse reactions and several deaths.
Separately, a recent study in the New England Journal of Medicine found the vaccine, which is approved for girls and young women ages 9 to 26, isn’t cost effectiveness for those older than 18. The benefit depends on how long Gardasil’s protection will last, although Merck contends the vaccine is cost effective for women through age 24. Gardasil costs about $360 for a three-dose regimen.
Hat tip to the WSJ Health blog

 

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