Ethics and Research with Children: A Case-Based Approach

By Eric Kodish | Go to book overview

13
Testing Drugs in Developing Countries: Pediatrie Research Ethics in an International Context

Michelle Eder


CASE DESCRIPTION

In 2001, a pharmaceutical company submitted a proposal to the Food and Drug Administration to study a new surfactant drug, Surfaxin, in premature infants with respiratory distress syndrome (RDS). The proposed trial design included three arms or treatment groups with 325 subjects in each arm: (1) a group receiving the new, experimental surfactant drug, Surfaxin; (2) a group receiving an established, approved surfactant drug; and (3) a placebo group. The company requested approval to conduct the study in four Latin American countries (Bolivia, Ecuador, Peru, and Mexico). Upon learning of the proposed trial, the directors of Public Citizen, a nonprofit consumer watchdog group, wrote a letter to the secretary of the U.S. Department of Health and Human Services labeling the study as unethical and urging that approval for the study be denied (Lurie, Wolfe, & Klaus, 2001). In the letter, they pointed out that this trial would not be permissible in the United States because a proven effective treatment exists and thus the use of a placebo arm would not be ethical. They also questioned the acceptability of testing the drug in a population that would not be able to afford it if it is proven effective.

The company justified their use of a placebo group in this study because the established drug is not available to the majority of people in the resource-poor Latin American countries where they plan to conduct the study (Flaherty & Stephens, 2001; National Bioethics Advisory Commission, 2001). Because they don't have access to the proven effective treatment, those in the placebo group would not be left any worse off than if they had not participated in the research. Also, the director of the company agreed to provide training, equipment, and Surfaxin, if proven effective, at a discounted cost for 10 years throughout the countries in which the study would be conducted (Charatan, 2001; Flaherty &

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