Heritage Update—

Sharyl Attkisson on Preemie Study: ‘The Federal Government, at the Very Least, Made a Mistake’

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Did a government-funded experiment put the lives of 1,316 premature babies at serious risk? Investigative journalist Sharyl Attkisson explains the ethical debate surrounding a multiyear study of these fragile infants, in the third part of her “Full Disclosure”series for The Daily Signal.

SUPPORT, a study that deliberately manipulated oxygen levels assigned to extremely premature babies, was sponsored by the National Institutes of Health, a branch of the Department of Health and Human Services. The body responsible for monitoring ethics violations in such studies, the Office for Human Research Protections, is also a part of HHS.

According to Attkisson’s report, this resulted in a “government vs. government” dispute. “The federal government funded the study, basically approved the study, [and] oversaw the study,” she said in the interview. “I think it’s clear that the federal government, at the very least, made a mistake.”

The HHS ethics body’s attempts to enforce what it found to be violations of the parental consent process stalled because of “pressure by the research community and by senior officials in the federal government who really didn’t want this to go much further,” Attkisson said. Going forward, she argues, “There needs to be something that’s said at the end of all this. What did the researchers do wrong, what do they need to do to correct this and make sure the same type of thing doesn’t happen again?”

Full Disclosure: Did Government’s Experiment on Preemies Hide Risks?

Just 25 weeks into her pregnancy, Sharrissa Cook gave birth to a critically ill baby boy. Dreshan weighed in at a fragile 1 pound, 11 ounces. He lay motionless in the incubator, connected to tubes and monitors in the neonatal intensive care unit at the University of Alabama at Birmingham Hospital.

“He was so tiny,” Cook recalls. “I was a first-time mom. I didn’t have a clue. I didn’t know what to expect.”

It was Oct. 11, 2006. Medical personnel asked Cook, then a 26-year-old single mother, to enroll little Dreshan in a study. She says they described it as a program offering assistance and encouragement to preemies—premature babies—and their families. She readily signed the consent form.

“I remember them telling me they were a support group who would pretty much hold my hand through the developmental process,” Cook says.

But in reality, the study was much more than that. It was a national, government-funded experiment on 1,316 extremely premature infants in which their fate may as well have rested with the flip of a coin.

Other single moms who were among those persuaded to sign up their critically ill babies at the University of Alabama at Birmingham Hospital describe similar misunderstandings of the study’s purpose.

Bernita Lewis, then a 22-year-old student, says she enrolled her premature newborn, Christian, after medical personnel told her it simply was to gather data such as weight and height.

And Survonda Banks, then 21, unemployed and on public assistance, says someone handed her the consent form on her way in for an emergency C-section at 28 weeks of pregnancy. Banks remembers being told only that it was a way to help her baby, Destiny.

‘Parents Were Misled’

The government-backed study is called SUPPORT, which stands for “Surfactant, Positive Airway Pressure, and Pulse Oximetry Randomized Trial.” The experiment was conducted at 23 academic institutions from 2005 through 2009 under the National Institutes of Health, part of the Department of Health and Human Services.

All three women now say they never would have agreed to take part if they had known the NIH-funded study’s true nature—to randomly manipulate preemie oxygen levels. They discovered that just last year.

Dreshan and Christian are now 7 years old and both struggle with myriad health problems. Destiny died within three weeks. The mothers wonder: Did the experiment contribute to any of the medical problems of their children?

“[Dreshan] was already at a slim chance of surviving; why would I make his chances of surviving more slim?” Cook asks.

 Read Part 2: ‘Input’ Stalls Agency’s Ethics Probe in Baby Oxygen Trials

 Read Part 3: Parents Fault Study for Putting Preemies in Harm’s Way