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 ethics standards 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 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.
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– a low range of oxygen (85-89% saturation) or a high range (91-95% saturation). .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. …
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