Surfactant trial in Latin American infants criticised

BMJ 2001; 322 doi: (Published 10 March 2001) Cite this as: BMJ 2001;322:575
  1. Fred Charatan
  1. Florida

    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.

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