Give babies what they need, or play Russian roulette with their lives?

Sharyl Attkisson exposes an experiment in which our government randomly manipulated preemie oxygen levels without the consent of the babies' mothers.

“The word ‘unethical’ doesn’t even begin to describe the egregious and shocking deficiencies in the informed-consent process for this study,” says Dr. Michael Carome, an internationally recognized expert on research ethics with the Washington, D.C.-based consumer watchdog group Public Citizen.

Medical personnel routinely give supplemental oxygen to babies who are born with immature lungs. Too much oxygen can cause severe eye damage, including a blood vessel disease and blindness called retinopathy. Too little oxygen can lead to brain damage and death.

The NIH-funded experiment used the test babies in an attempt to find the sweet spot for preemies yet to be born: the lowest level of oxygen that would preserve vision, yet be sufficient to prevent brain damage and death.

To get the answer, researchers arbitrarily assigned infants to either a high-oxygen or low-oxygen group. Because, researchers say, all oxygen levels fell within the generally accepted range, they argue the babies received the same “standard of care” as babies not in the study. None of the consent forms mentioned a risk of death from the oxygen experiment.

But it turns out there were key differences in how researchers treated babies in the study compared with those not in the study.

Normally, medical personnel constantly adjust oxygen as preemies’ conditions change, based on their individual needs. But the SUPPORT study was designed to keep infants in their randomly assigned range, despite a baby’s individual needs.

And in a decision that one government source says shocked seasoned researchers when they learned of it, the babies’ oxygen monitors intentionally were altered to provide false readings. The reason: so medical staff wouldn’t be tempted to adjust oxygen out of the babies’ study-assigned range.

“Nothing in the consent form explained the falsely reading oxygen monitors could lead to adverse decisions about care of the babies,” Carome, who directs Public Citizen’s Health Research Group, says in an interview. He calls both the study design and consent form unethical.

More of the high-oxygen babies ended up with serious vision disorders. The low-oxygen preemies were more likely to die. The results, published in the New England Journal of Medicine in May 2010, sparked ethical questions and complaints. Companion studies being conducted in other countries were halted.

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