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More Information on Ethics and Clinical Trials

More information on surfactant (Surfaxin)

Description of Efforts to Redesign Surfactant (Surfaxin) Study in Latin America

February 17, 2007

In 2001, Public Citizen criticized a proposed study by the United States drug company Discovery Laboratories. The study would have explored the effectiveness of Discovery's drug Surfaxin in the treatment of Respiratory Distress Syndrome, a sometimes-fatal disease of premature infants, in four Latin American countries. Although four similar surfactant drugs were already approved in the United States and had been shown to reduce mortality rates by about one-third, the company proposed giving half of the patients a placebo (sham treatment), reasoning that in those countries people did not receive surfactant anyway. Public Citizen mounted an ultimately successful campaign against the trial. In 2007, we published a book chapter describing the circumstances surrounding this trial:

Lurie P, Wolfe SM. The developing world as the "answer" to the dreams of pharmaceutical companies: the Surfaxin story. In: Lavery JV, Grady C, Wahl ER, Emanuel EJ. Ethical Issues in International Biomedical Research. Oxford University Press, Oxford, 2007, pp. 159-70.

The chapter is available as a pdf

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