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Doctors in a federal research study allegedly deprived premature babies of oxygen in a medical experiment and also lied to young and poor mothers to get them to volunteer their infants, according to new documents.
“Parents of the infants who were enrolled in this study were misled about its purpose,” Dr. Michael Carome of the political group Public Citizen told the Daily Signal. “They were misled to believe everything being done was in the ‘standard of care’ and therefore posed no predictable risk to the babies.”
“The word ‘unethical’ doesn’t even begin to describe the egregious and shocking deficiencies in the informed-consent process for this study,” Carome told journalist Sharyl Attkisson.
Carome was referring to the Surfactant, Positive Airway Pressure and Pulse Oximetry Randomized Trial or SUPPORT conducted at the University of Alabama Medical Center in Birmingham and other facilities from 2006 to 2009.
The details of the experiment uncovered by Attkisson are absolutely disturbing.
With premature babies, giving them too little oxygen puts them at a greater risk for brain damage and death. Too much oxygen can result in blindness.
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Doctors in the experiment were trying to find the “sweet spot.” The problem, though, was that babies in the study were treated differently than other babies. Normally, the oxygen level for a baby is adjusted depending on its needs. But premature babies in the study were given a randomly assigned oxygen level that remained constant, no matter the need. Oxygen monitors were rigged to provide false readings so caregivers would not know babies were not getting enough oxygen or were getting too much.
Around 1,316 infants participated in the study, and it was conducted at 23 locations from 2005 through 2009 under the National Institutes of Health (NIH).
The study cost taxpayers $20 million, with medical professors from top institutions including Yale, Duke University and Wake Forest University taking part.
The results of the study were published in The New England Journal of Medicine.
“I remember them telling me they were a support group who would pretty much hold my hand through the developmental process,” Sharrissa Cook said of the researchers. Cook’s son, Dreshan, who was born premature, was one of the test subjects. He is 7 now and has many health problems.
Even the consent form mothers were asked to sign was a lie, they said.
“Nothing in the consent form explained the falsely reading oxygen monitors could lead to adverse decisions about care of the babies,” Carome noted.
Cook said she wouldn’t have volunteered Dreshan if she had known what was really going on.
“That’s more like playing Russian Roulette to me,” Cook said of SUPPORT. “There’s no way I would say you could give my baby whatever you want him to have as opposed to what he needs.”
Some of the babies involved in the “experiment” developed serious health problems.
Similar studies in other nations were shut down when doctors became aware of the unethical nature of SUPPORT.
Doctors defended their actions and the program.
“Our consent forms were conscientiously drafted according to the Code of Federal Regulations and were based on the best available evidence,” Dr. Waldemar Carlo of the University of Alabama wrote in The New England Journal of Medicine.
“Sensational claims of calling people unethical, I think, really detract from the serious discussion that needs to occur,” Robert Califf, the vice chancellor of clinical research at Duke University, told Attikisson.
Do you believe this study was ethical? Tell us in the comments section below.
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