A consumer group has urged the Bush administration to stop a U.S. company from giving premature babies in Latin America a placebo instead of proven lung therapy in its quest to test an experimental drug.
The planned study is “unethical and exploitive,” and will result in the preventable deaths of at least a dozen infants suffering respiratory distress syndrome, said Dr. Peter Lurie of the consumer advocacy group Public Citizen.
The complaint comes as scientists worldwide debate if it’s ever ethical to compare experimental drugs to placebos, or dummy therapy, when a proven but competing treatment exists.
It’s a particularly tough issue when U.S. scientists experiment in poor countries that can’t afford existing therapy, prompting questions of why a placebo there would be a problem — or if rich countries are obligated to provide expensive treatments in return for doing research.
Respiratory distress syndrome, or RDS, often strikes premature infants’ underdeveloped lungs. Several competing drugs called surfactants today are sprayed into those babies’ lungs, reducing RDS deaths by 34 percent.
Pennsylvania-based Discovery Laboratories has created a new synthetic version called Surfaxin that it contends may be a better alternative to top-selling surfactants made from cow or pig cells.
Is a Placebo-Controlled Study Ethical?
Internal Food and Drug Administration documents say comparing Surfaxin to a placebo in U.S. babies with RDS would be unethical, but that the agency is considering whether to approve a placebo-controlled study in parts of Mexico, Bolivia, Peru and Ecuador.
“The researchers have hit upon the idea of experimenting on the poorest of the poor,” Lurie wrote Health and Human Services Secretary Tommy Thompson on Thursday, urging him to stop the plans.
But Discovery Labs Chief Executive Robert Capetola vigorously defended the planned study: “It’s unethical not to do it.”
The participating Latin American hospitals cannot afford today’s $2,200 surfactant treatment, so their preemies get nothing but ventilator care. The proposed study would give hundreds of infants either Surfaxin, the proven competitor Survanta or the “placebo” of standard supportive care.
Capetola said cutting out that third comparison would cost an extra year in telling whether Surfaxin works and then selling it for needy babies — and he pledged to sell Surfaxin at a reduced cost in Latin America.
He added that speed also is important because other cow-derived surfactants raise fear of mad cow disease, something the FDA strongly disputes.
In Europe, Surfaxin already is being studied in comparison to a proven competitor, and there shouldn’t be lower standards for the Latin American study, Public Citizen said.
FDA drug chief Dr. Janet Woodcock said the agency hasn’t decided if the proposed study is ethical, but is carefully debating the question.
Thompson spokesman Bill Hall said the HHS secretary won’t interfere in the agency’s decision.