US FDA "to approve unethical study"

Public Citizen's Health Research Group, the US consumer advocacy group,has vowed to pledged to halt a clinical trial which it says the Food and Drug Administration is about to approve involving Discovery Labs' Surfaxin (lucinactant) in the treatment of pediatric respiratory distress syndrome.

While the trial, which is due to take place in four Latin American countries, will involve giving Surfaxin to premature infants with RDS, a control group of 325 infants with the disease will receive a placebo. The HRG has written to US Health and Human Services Secretary Tommy Thompson, stating that this use of placebo is highly unethical, and pointing out that such a trial would not be allowed to take place in the USA.