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Placebo-Controlled Drug Trial in Latin America Redesigned

April 4, 2001

Placebo-Controlled Drug Trial in Latin America Redesigned

Company will Provide Active Treatment to All Infants

WASHINGTON, D.C. — Following a campaign by Public Citizen, Discovery Laboratories Inc. of Doylestown, Penn., has redesigned its study of Surfaxin, its brand of the drug surfactant, which is used to treat Respiratory Distress Syndrome (RDS) in premature infants. Under the new design, no infants will receive a placebo.

“This should make it clear to all clinical researchers that developing countries are not to be used as a dumping ground for unethical research,” said Dr. Peter Lurie, deputy director of Public Citizen?s Health Research Group. “There should be no question now that exploiting the poverty of developing country residents is completely unacceptable. We hope that no company will be so foolhardy as to consider such exploitative research again.”

On Feb. 22, 2001, Public Citizen wrote to Health and Human Services Secretary Tommy Thompson urging him to prevent the Food and Drug Administration (FDA) from endorsing a study design in which hundreds of infants would receive placebos instead of one of the four FDA-approved surfactants. Another study planned by the company in Europe gave all infants either the company?s surfactant or a known effective surfactant. That study did not use placebos.

The Latin America study was to have been conducted in at least one of four countries (Mexico, Bolivia, Ecuador and Peru), even though the company acknowledged that surfactant is available to some infants in those countries. The company planned to conduct the study in hospitals without the drug. As the FDA admitted, “Conduct of a placebo controlled surfactant trial for premature infants with RDS is considered unethical in the USA.”

The proposed trial was in clear contravention of the October 2000 Declaration of Helsinki, which requires that, “The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods.” The new trial design would comply with the Declaration.