Despite oxygen meters not working right, an experiment of 1,300 premature infants continued, according to public records uncovered by a health advocacy group show.
Buzzfeed reports that the patient advocacy group Public Citizen obtained documents and emails revealing the troubling information. However, scientists who ran the study claim the broken meters gave the infants more, not less, oxygen than expected.
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The problem was discovered three years into the study and while researchers notified the trial's safety board, the trial was not changed or stopped according to the documents.
"This is very worrisome," neonatal pediatrics professor Neil Finer replied to British colleagues who informed him of the issue in June 2008.
Finer, then of the University of California San Diego School of Medicine, was a leader of the study which sought to determine whether premature infants benefit more from high or low levels of oxygen. The study, which involved 23 hospitals and cost $20 million, has already provoked controversy regarding whether consent forms properly warned parents of risk.
A lawsuit regarding the consent and warnings was dismissed in 2014.
These new concerns regarding the oxygen meter issues are prompting more serious questions about when researchers should halt clinical trials. According to a 2008 analysis by British researchers, as many as half of the babies in the study may have been exposed to dangerous periods of low oxygen or hypoxia.
"The ethical thing to do at that point would have been to halt the experiment," former federal research misconduct official Michael Carome said. Carome now works for Public Citizen.
Trial leaders are defending the decision to continue the study. Rosemary Higgins, now of the National Institute of Child Health and Human Development, said in a statement that "those in the low oxygen group would have received more oxygen than the study design called for, not less."
Despite the assertion, people are concerned about the study not stopping upon discovery of the faulty meters.
"It seems everyone crossed their fingers and hoped for some significant results. But not necessarily the ones they got," University of Pennsylvania bioethicist Jon Merz said. "I would like to think that if I were on the [safety board], I would have voted differently."
The study was published in New England Journal of Medicine in 2010.
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