The question of human testing is often divided between the need to do research for the greater good, and the right of human test subjects to know exactly what they’re signing up for. Sharyl Attkisson with Full Measure reports on a federal study conducted in 2004 on the most vulnerable of humans: extremely premature infants. Some parents say they had no idea they agreed to a risky experiment that could injure or kill their babies.
Mothers of these severely premature babies were frightened when they signed a consent form to enroll their babies in a study called SUPPORT (“Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial”). Funded with $20.8 million tax dollars, it was a collaboration among the National Institutes of Health and two dozen research bodies, including Duke and Yale universities and medical schools.
Sharissa Cook, who was barely six months pregnant with her son Dreshan when she went into labor, described herself as a “hysterical wreck” and in shock at her baby’s early birth with a weight of 1 pound, 11 ounces. It was under these conditions she was given consent forms to sign her baby up for the SUPPORT study.
Cook said the hospital gave the impression she was simply signing up to get support in caring for a preemie and “that even with his prematurity being as extreme as it was, that it would be okay because I had all of this help.”
Cook said she had no clue that the SUPPORT study was actually a national experiment on 1300 extremely premature infants.
Bernita Lewis also agreed to enroll her baby Christian, born at 27 weeks, in the SUPPORT study at the same hospital, the University of Alabama at Birmingham. She says a hospital worker told her the study was just to collect data on her son, who weighed 1 pound, 9 ounces.
“They wanted to use his medical records to help babies in the future,” recalled Lewis. “I told them absolutely, they could use any records they wanted to use.” Lewis was not informed of the possible risk of death for her infant.
SUPPORT researchers had good intentions. They already knew that without enough oxygen, preemies could get brain damage or die; but with too much oxygen, they could go blind. The SUPPORT study was searching for the “sweet spot.” The question was what level of oxygen would be optimum in order to save as many babies as possible without having the survivors become blind.
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To find out, the infants were randomly assigned – with the flip of a coin – to either a low-oxygen group or a high-oxygen group. The study reached a tragic conclusion: the babies in the high-oxygen group were more likely to go blind; those unlucky enough to have been put in the low-oxygen group were more likely to die. When the findings became known, similar research around the world was halted mid-stream.
Bio-ethicist Dr. John Lantos defended the SUPPORT study as an expert witness against families who unsuccessfully sued for damages.
“This was a study that was well-designed,” he insisted, “conducted to the highest ethical standards, with a completely adequate consent that was conducted without harming any babies, and led to an important finding that’s going to save lots of lives.”
On nearly every point, Dr. Michael Carome disagrees. An internationally recognized expert on research ethics at the watchdog group Public Citizen, he says parents were not told the exact purpose of the research, nor its experimental nature or risks involved.
Adding to the controversy, researchers didn’t tell parents a remarkable fact: they had altered the infants’ oxygen monitors to give false readings so the hospitals wouldn’t adjust them outside of their assigned low or high oxygen range.
“This is extremely serious and about as bad as it gets,” said Dr. Carome.
“It seems to me that there’s a lot of second guessing, armchair quarterbacking and playing ‘gotcha’ here,” countered Dr. Lantos.
The debate would be purely academic if it weren’t for an extraordinary turn of events: after questions were raised, the Office for Human Research Protections – the government agency that polices study ethics – sided with critics and issued a searing indictment of the government-led study due to violations of government regulations for informed consent; specifically, for their “failure to describe the reasonably foreseeable risks of blindness, neurological damage and death.”
The concept of informed consent arose from the infamous government syphilis experiment on black men in Tuskegee, Alabama in 1932. For 40 years, the men were neither told they were in a study nor treated for their syphilis. An outcry in 1972 led to new rules: researchers are now required to disclose risks to test subjects, and get their voluntary informed consent.
Studies like SUPPORT must be approved by ethics experts when the research is conducted. The consent forms from 22 institutions “all failed in their duty to protect human subjects in this study,” insisted Dr. Carome.
But Dr. Lantos disagrees. “Most of the criticism is not coming from parents, but from regulators who, in my opinion, don’t really understand the circumstances of oxygen therapy,” he said.
The parents did not find out about the true risk until the surviving test children were six years old. Lewis is adamant she would never have consented to the study had she known of the risks involved. “Absolutely not,” she said. “No.”
Parents of the study were never offered apologies. Instead, the SUPPORT researchers made a bold new claim that’s been particularly controversial: they said the babies were actually better off for having been in the study.
“The risks of not being in that study were comparable to the risks of being in that study,” insisted Dr. Lantos, “and perhaps even higher.”
Dr. Carome argues that’s simply wrong. “There’s no doubt that some babies, because they were in this study, died as a result,” he said.
Amid the criticism, the SUPPORT researchers and National Institutes of Health dug in. They launched a public campaign of opinion letters and meetings to attack the Office for Human Research Protections and pressured it to suspend enforcement action.
Mothers of the premature babies involved in the SUPPORT study are left wondering whether the lingering health effects their children suffer were exacerbated by the research, or whether they are simply the condition of being born too early.
More than 80 years after the Tuskegee experiments, the SUPPORT study has reopened painful wounds, and is raising questions as to whether the protections for human test subjects are fundamentally flawed.
Attkisson notes those who conducted the study, and the federal government at large, have basically said they don’t think they’ve done anything wrong, but Cook disagrees.
“I don’t see how anyone can say ‘nothing was wrong’ with playing Russian roulette with babies – babies who had no say-so, no choice, no anything, just trying to survive,” said Cook.
After the study revealed more deaths among babies with low oxygen, the American Academy of Pediatrics issued new recommendations to keep preemies at the upper end of the oxygen curve. In other words, doctors should not do what the SUPPORT researchers did to half the babies.