Ethics and Research with Children: A Case-Based Approach

By Eric Kodish | Go to book overview

3
Optimizing Risks and Benefits: The Case of Rotavirus Vaccine

Susan E. Coffin and Robert M. Nelson

In August 1998, the U.S. Food and Drug Administration (FDA) licensed a new vaccine to prevent rotavirus, the most common and serious cause of gastroenteritis among children living in either developed or developing nations (CDC, 1999a). Fourteen months later, the vaccine was withdrawn from the U.S. market due to concerns about a rare gastrointestinal side effect known as intussusception (CDC, 1999b, 1999c). The estimates of the attributable risk of the vaccine have varied in several well-designed case-control studies (Chang, Smithe, Ackelsberg, Morse, & Glass, 2001; Kramarz, France, & Destefano, 2001; Murphy, 2001; Simonsen et al., 2001); thus, the debate about the significance of the association between rotavirus vaccine and intussusception continues. Some researchers and public health officials have questioned the wisdom of revoking the original recommendation to vaccinate U.S. infants (Murphy, 2003). In addition, international public health agencies continue to weigh the risks and benefits of this vaccine for children who live in developing nations (Schael-Perez, 2001; Walker, Akaramuzzaman, & Lanata, 2001; Weijer, 2000).

In this chapter, we examine the events surrounding the development, licensure, and discontinuation of this rotavirus vaccine. We explore ethical issues that are raised by this case and that have dominated the growing debates over national and international vaccine research: how the risks and benefits of vaccines are measured, what is considered an acceptable balance between vaccine-related risk and benefit, and what happens when U.S. vaccine policy clashes with international public health concerns.


CASE DESCRIPTION

The Disease

Worldwide, rotavirus is the most common cause of serious gastroenteritis. In both developed and developing countries, virtually all children are infected with

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