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By John Aman
Vulnerable, first-time single mom Sharrissa Cook signed up for what sounded like a support group after she delivered her son, Dreshan, born at 25 weeks and weighing a feather-light 1 pound, 11 ounces.
Instead, Cook, then 26, unknowingly put her critically ill, preemie son into a federally funded, experimental trial that subjected babies to the risk of brain injury, blindness and even death.
“I was under the impression this was more of a support group … where they would be holding our hand throughout the process,” she told a public meeting hosted by the U.S. Department of Health and Human Services last August.
Cook’s confusion stems from the experiment’s name, SUPPORT, which stands for Surfactant, Positive Pressure and Oxygenation Randomized Trial.
Instead of a support group, what she actually joined was a controversial, federally financed research effort to determine the best oxygen levels for severely premature infants.
Handed consent form on way to C-section
Other mothers recruited into the study also misunderstood what it was, according to former CBS News reporter Sharyl Attkisson, who covered the SUPPORT controversy in a series of articles for the DailySignal.com, a Heritage Foundation news site.
Health workers told Bernita Lewis, then 22, that the purpose of enrolling her preemie son was to collect information, including weight and height.
Survonda Banks, then 21, was on her way to an emergency C-section when a worker gave her a consent form. Attkisson reports that “Banks remembers being told only that it was a way to help her baby, Destiny.”
The SUPPORT study was conducted from 2005 to 2009 and involved 1,300 infants born at 24 to 27 weeks. It took place in 23 medical centers nationwide and was led by the University of Alabama at Birmingham. The $20.8 million preemie research program was conducted under the National Institutes of Health, a branch of the Department of Health and Human Services.
“I trusted them with my baby’s life”
“I trusted them with my baby’s life,” Cook said last August. “I feel there was a lack of information given to parents, and because of this, I feel taken advantage of and I feel responsible for my child’s participation in this study.”
Watch Cook’s comments below:
Dreshan is now 7 years old and struggles with "myriad health problems," according to Attkisson's report.
Shawn and Carrie Pratt also participated in the study after their daughter Dagen was born at 25 weeks, weighing 1 pound, 11 ounces.
"We were guaranteed that the study wouldn't hurt Dagen in any way, that it was just gathering information," Shawn Pratt said at the HHS public meeting last August.
The Pratt's "sole motivation" was the health of their daughter, he said. "We assumed her doctors felt the same and were shocked to learn the care she received was based not on what she needed but on some protocol. In our minds the SUPPORT study turned Dagen into a subject of an experiment, instead of a participant in a study."
The preemies in the study were randomly placed into two groups and given either higher or lower levels of oxygen. Supplemental oxygen is life-giving for preemies, who have difficulty breathing because their lungs are not fully developed, but high oxygen levels can also lead to retinopathy of prematurity and vision loss.
A goal of the study was to identify a sweet spot between putting babies at risk for eye disease from too much oxygen and causing death because of inadequate oxygen.
The risks were not disclosed to parents, charges Public Citizen, a left-leaning consumer advocacy organization founded by Ralph Nader.
"The consent forms for the SUPPORT study had egregious deficiencies, and there was a failure to disclose the serious risks of the research, including the risk of death, brain injury and blindness from an eye disease called retinopathy of prematurity," says Michael Carome, M.D., director of Public Citizen's Health Research Group. "We believe that had parents been adequately informed, many would not have enrolled their premature infants in this study."
Actual results from the experiment reveal the risks. More infants died in the low-oxygen group – 19.9 percent, or 130 out of 654 – than did preemies in the high-oxygen group – 16.2 percent, or 107 out of 662.
Infants died as a result of study
"I have no doubt that some infants died because of their participation in the research, and had they not been in the research they wouldn't have died," says Carome, a former senior leader at the Office for Human Research Protections, or OHRP, within the Department of Health and Human Services.
Preemies in the higher oxygen group developed eye disease at more than twice the rate of those in the low-oxygen branch of the study, 17.9 percent versus 8.6 percent. OHRP, the HHS watchdog for research on humans, called that result "highly significant" and criticized the scientists who did the study in a March 2013 letter, asserting that "participating in the study did have an effect on which infants died, and on which developed blindness."
OHRP also determined in its letter to the University of Alabama at Birmingham, the lead site for the experiment, that "the informed consent document for this trial failed to adequately inform parents of the reasonably foreseeable risks and discomforts of research participation."
Research community rallies in support
Many in the research community, including the NIH, fired back and vigorously defended the SUPPORT study.
"We are dismayed by the response of the OHRP and consider the SUPPORT trial a model of how to make medical progress," three medical professionals wrote in the New England Journal of Medicine.
NIH Director Dr. Francis Collins and two colleagues took the rare step of publicly disagreeing with OHRP in the New England Journal of Medicine.
And they did more than disagree. Public Citizen obtained emails through a Freedom of Information Act request revealing a coordinated effort by senior NIH and HHS officials to interfere in OHRP's investigation.
Specifically, NIH was given the opportunity to view and edit drafts of a second OHRP letter, dated June 4, 2013, in which OHRP placed "on hold" compliance actions against the University of Alabama at Birmingham, the SUPPORT study leader.
"Such interference by NIH is unprecedented in my knowledge of the office," said Carome, who spent 24 years in the U.S. Public Health Service.
Despite the NIH intervention, OHRP's second letter affirmed its earlier determination that the study inadequately informed parents of the risks their children faced by enrolling in the experiment.
Do researchers shade truth to recruit participants?
Asked if researchers shade the truth when recruiting study participants, Carome listed the pressures at play.
"Investigators are motivated to get their research done as quickly as possible so they can get grant dollars so they can get funding for research so they can get published in publications to advance their academic careers," he said. "Too often I think investigators write consent forms where the risks are downplayed, where the benefits are overstated, where the nature of the research is not clear in order to avoid discouraging potential subjects from enrolling in the research."
Shawn and Carrie Pratt still don't know why researchers urged them to participate in a study that posed additional risk to their fragile, extremely premature daughter. And they wonder whether it is a factor in their daughter Dagen's health problems, which include "multiple incidences of collapsed lungs, breathing problems and other life-threatening conditions," Attkisson reports. Dagen has cerebral palsy and had laser eye surgery at two months for retinopathy.
"Why were we not fully informed of the risk and why is omitting information not considered lying?" Carrie Pratt asked at a press conference last August, held on the sidewalk outside the Health and Human Services headquarters in Washington, D.C.
"We're very blessed that Dagen survived and has her eyesight, but every day that she cries because she is different, it just kills us. And we worry about her future as a special needs child, and especially as an adult."
Watch the Pratt family's press conference below:
John Aman is a writer and communications consultant. He is the author of "Ration Care: The Powerful Unelected Board that Threatens Health Care in America" and formerly worked for one of the nation's largest Christian broadcast ministries.