Writing for The Daily Signal, award winning investigative reporter Sharyl Attkisson is reporting on a government-backed study known as SUPPORT (Surfactant, Positive Airway Pressure, and Pulse Oximetry Randomized Trial) which was conducted at 23 academic institutions from 2005 through 2009 under the National Institutes of Health (NIH).
The study involved manipulating the oxygen levels given to extremely preterm infants - those born before 25 weeks. Because too much oxygen can cause eye damage and too little oxygen can lead to brain damage and death, doctors experimented on the infants to determine the best level of oxygen.
While this doesn't sound too bad, the problem is with how the study was conducted.
In the study, infants were assigned to either a high-oxygen or low-oxygen group. Doctors claimed the babies in both groups received oxygen levels that were within generally acceptable ranges; however, medical personnel were not permitted to adjust the oxygen levels assigned to the babies in the experiment as they would normally do for preemies whose conditions change. Even more shocking is that the babies' oxygen monitors were deliberately altered to provide false readings so that medical staff would not attempt to adjust their oxygen levels.
"More of the high-oxygen babies ended up with serious vision disorders. The low-oxygen preemies were more likely to die," Attkisson reports. "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."
And for good reason. Not only was the study conducted in a risky way, but parents were never told about the true nature of the experiment. Instead, they were asked to sign a consent form which described the program as one that offered assistance and encouragement to premature babies and their families. As one mother explained to Attkisson, they told her that they were a support group who would "pretty much hold my hand through the development process."
Another single mother named Bernita Lewis, 22, said she enrolled her newborn into the program after being told it was simply going to gather data such as height and weight.
Survonda Banks, then 21 and unemployed, said she was handed a consent form on her way into the operating room where she delivered a 28 week-old baby named Destiny. She remembers being told that the program would help her baby.
None of these parents found out about the true nature of the experiment until last year. Because at least one of the babies, Destiny, died, and two others that Attkisson followed up on have many health problems, their parents are now wondering if the experiment could have contributed to these issues.
"Today, nine months after the federal government convened a public meeting to examine the subject, NIH and HHS officials have yet to propose a remedy to avoid a repeat of the controversy that erupted from the multiyear study," Attkisson reports.
“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 expert on research ethics with the Washington, D.C.-based consumer watchdog group Public Citizen.
“Parents of the infants who were enrolled in this study were misled about its purpose. They were misled to believe everything being done was in the ‘standard of care’ and therefore posed no predictable risk to the babies. . . Nothing in the consent form explained the falsely reading oxygen monitors could lead to adverse decisions about care of the babies."
Dr. Waldemar Carlo, director of the neonatology division at the University of Alabama at Birmingham Hospital says none of the institutions that took part in the program did anything wrong.
In a letter he wrote to the New England Journal of Medicine last spring, he insisted that “our consent forms were conscientiously drafted according to the Code of Federal Regulations and were based on the best available evidence.”
To make matters worse, it now appears that government officials may have tampered with an ongoing ethics probe into the SUPPORT program.
On May 20 of this year, Public Citizen and nine prominent scholars went public with charges that senior NIH and HHS (Department of Health and Human Services) officials engaged in serious misconduct by interfering with an ethics office in HHS as it investigates the experiment on preemies, Attkisson is reporting.
Rep. Rosa DeLauro, D-Conn., has also called upon the HHS inspector general to determine whether officials “compromised the integrity and independence” of the ethics probe.
Meanwhile, parents whose babies were involved in the study are left to wonder if they'll ever know the impact this flawed experiment had on the health of their children.
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