Group: Drug Study Unethical

W A S H I N G T O N, Feb. 23 -- A consumer group has urged the Bush administration to stop a U.S. company from giving premature babies inLatin America a placebo instead of proven lung therapy in its questto test an experimental drug.

The planned study is “unethical and exploitive,” and willresult in the preventable deaths of at least a dozen infantssuffering respiratory distress syndrome, said Dr. Peter Lurie ofthe consumer advocacy group Public Citizen.

The complaint comes as scientists worldwide debate if it’s everethical to compare experimental drugs to placebos, or dummytherapy, when a proven but competing treatment exists.

It’s aparticularly tough issue when U.S. scientists experiment in poorcountries that can’t afford existing therapy, prompting questionsof why a placebo there would be a problem — or if rich countriesare obligated to provide expensive treatments in return for doingresearch.

Respiratory distress syndrome, or RDS, often strikes prematureinfants’ underdeveloped lungs. Several competing drugs calledsurfactants today are sprayed into those babies’ lungs, reducingRDS deaths by 34 percent.

Pennsylvania-based Discovery Laboratories has created a newsynthetic version called Surfaxin that it contends may be a betteralternative to top-selling surfactants made from cow or pig cells.

Is a Placebo-Controlled Study Ethical?

Internal Food and Drug Administration documents say comparingSurfaxin to a placebo in U.S. babies with RDS would be unethical,but that the agency is considering whether to approve aplacebo-controlled study in parts of Mexico, Bolivia, Peru andEcuador.

“The researchers have hit upon the idea of experimenting on thepoorest of the poor,” Lurie wrote Health and Human ServicesSecretary Tommy Thompson on Thursday, urging him to stop the plans.

But Discovery Labs Chief Executive Robert Capetola vigorouslydefended the planned study: “It’s unethical not to do it.”