Surfactant trial in Latin American infants criticised
- By: Fred Charatan
A new drug trial on infants in Latin America has been criticised as unethical because the control group of babies in the trial will be given a placebo rather than another, effective drug. Critics point out that it contravenes the newly revised Declaration of Helsinki, which states that new treatments should always be tested against the best current method, where that exists (BMJ 2000;321:913).
Discovery Laboratories of Doylestown, Pennsylvania, has planned a placebo controlled study in Latin America of sinapultide (Surfaxin), a new drug for treating the idiopathic respiratory distress syndrome in premature newborn infants.
Public Citizen, a Washington based, non-profit making, consumer watchdog, has written to Tommy Thompson, the new US health secretary, condemning the study design as “exploitative.” The control group of 325 premature infants will be treated with placebo, instead of a lifesaving surfactant drug approved by the Food and Drug Administration (FDA). Many infants given placebo