11 Apr (AHRP) – Is it progress when US government sponsored medical research moves from deliberately infecting Guatemalan men with syphylis to designing experiments that kill premature babies? Ten years ago, the Office of Human Research Protection (OHRP) found that two federally sponsored lung experiments conducted by the ARDS Network at 12 major academic centers , had violated medical ethicsstandards by exposing non-consenting critically ill patients to increased risk of death, and had failed to comply with legal informed consent requirements. Today we learn that the National Institute of Health (NIH) sponsored the so-called SUPPORT experiment conducted on 1,316 extremely prematurebabies at 23 prominent academic medical research centers. These include: Stanford University, Yale University, Brown University, Duke University, Wake Forest, and University of Alabama at Birmingham (a complete list is at the end). Two of the medical centers–Duke and Wake Forest–were also involved in the ARDS experiments.
SUPPORT was designed to find out whether premature babies whose fragile lungs required oxygen, were more likely to die or become blind, if their oxygen levels were targeted to either a low or high range. The subjects in both the ARDS abd SUPPORT experiments required individualized titration of oxygen levels based on the individual patient’s clinical condition, and requiried continuing monitoring and oxygen level adjustment–as is current best practice. In both cases, the treatment provided to critically ill patients in these experiments did not meet that standard of care.
Critical care physicians have long been known that giving high levels of oxygen to premature infants can lead to retinal damage, blindness and lung injury; giving too little oxygen can cause brain damage and death. The SUPPORT study design increased risks of either death or retinal damage leading to blindness, depending on which oxygen level group a baby was randomized to.
At the 23 participating medical centers, premature infants who were not subjects in the experiment were maintained at oxygen levels within a range of 85% to 95% based on a baby’s individual medical condition and needs. By contrast, infants enrolled in the SUPPORT experiment were randomly assigned to either a low range of oxygen (85-89% saturation) or a high range (91-95% saturation). Babies enrolled in the experiment were taken off the individualized level of oxygen they had received and were randomly assigned to either of the two oxygen ranges. OHRP’s letter of determination (March 7, 2013) states:
“The SUPPORT study was designed as an interventional study. It specifically enrolled very premature infants and randomized them to one of two levels of oxygen. For many of those infants, the level of oxygen they received was different from what they would have received had they not participated in the study.
A major purpose for doing this was to increase the likelihood that there would be a measurable difference in the outcomes of the two groups. The primary outcome of interest for the researchers was whether the infants would develop severe eye disease or would die before being discharged from the hospital.”
This experiment qualifies as a medical atrocity of the worst kind–yes, it does compare with the Nazi era experiments.
The physicians who conducted the experiment failed to comply with Federal informed consent requirements. They failed to disclose the purpose of the experiment to the parents; failed to disclose the risks for the infants of being randomized to either of the two treatment arms that were used in the experiment; and failed to inform parents about the available alternative individualized treatment. They feared they would not gain parental permission for the infants’ enrollment in the experiment.
Neither the premature infant SUPPORT experiment, nor the ARDS Network experiments met that ethical / legal standard because neither had current practice controls and it is unknown if the therapies they tested–both experimental–had both worsened care and if adopted in perpetuity will worsen care.
The statistically significant (p-vaue) finding for harm in this neonatal study only tells the authors they hurt babies more in one arm than the other. But the authors have no idea if they hurt babies in both arms compared to what is usually done in practice. Pediatric specialists in intensive care units use the level of oxygen titrated so that it will still be high enough to keep the child alive and low enough hopefully to prevent blindness for that baby–that requires careful attention to the individual child’s condition. In each child different factors based on their unique medical co-morbidities go into making that decision.
The physicians who conducted the experiment failed to minimize the risks because without controls they had no way to monitor the babies’ safety. They failed to comply with Federal informed consent requirements because they knew that if they honestly explained to parents what would be done in the trial:
-Babies would be given a fixed experimental treatment independent of the individual baby’s needs
-These fragile premature babies would be at greater risk of more blindness in one arm, and more deaths in the other
no parent would agree to put their baby in such an experiment. By their omission,they effectively lied to the parents.
This was a physiology experiment usually designed for animals. Nothing was learned. Only what was already known-that low oxygen kills and high oxygen makes you blind. OHRP received a complaint about the SUPPORT experiment about two years ago. The agency’s response was a letter of determination to the University of Alabama at Birmingham on March 7, with copies to the other 22 research centers. But OHRP did not take any action, nor did OHRP demand that the the universities and hospitals involved take any meaningful actions to prevent repeated gross ethical / legal violations.
Furthermore, as Public Citizen informed HHS Secretary Sebelius in a letter (April 10, 2013)
“Consistent with what had been known for decades, the SUPPORT study results demonstrated a statistically significant greater number of cases of serious retinal damage in the high – oxygen group compared with the low – oxygen group. In addition, as suspected for many years, the study revealed a statistically significant higher death rate in the low – oxygen group compared with those in the high – oxygen group.”
For complete article go to AHRP.
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Tags: ARDS Network, Dr. Richard Marchase, National Institute of Health, NIH, Office of Human Research Protection, OHRP, p-vaue, SUPPORT experiement, The University of Alabama at Birmingham, V-P for Research & Economic Dev. At the University of Alabama at Birmingham