Details about a controversial study conducted by the National Institutes of Health are emerging thanks to watchdog group, Public Citizen. The study was conducted between 2005 and 2009 and "tested two experimental strategies for managing oxygen treatment in premature babies, with one group maintained at a low blood oxygen level and the other at a high level." The study was unethical for two reasons: the consent form failed to adequately inform parents of the potential risks (blindness, neurological damage, death) to children exposed to lower levels of oxygen and the study utilized deceptive techniques (false readings - either high or low - on pulse oximeters) on live human subjects which resulted in blindness, neurological damage and in some cases, death.
Background of the SUPPORT Study
In a letter to former Health and Human Services Secretary, Kathleen Sebelius, Public Citizen details concerns about both the misleading consent forms and the unethical construct of the clinical trials.
"The SUPPORT study involved 1,316 extremely premature infants enrolled between 2005 and 2009 at more than 20 prominent medical research centers throughout the U.S.3 The study comprised two simultaneous experiments. In one experiment, the babies were randomly divided into two groups that each received a different treatment to assist their breathing (ventilation of the lungs) following delivery. In the other, simultaneous experiment, which is the primary focus of this letter, babies were further randomly divided between a low-oxygen group and a high- oxygen group. For the low-oxygen group, the SUPPORT study investigators tried to maintain the babies' blood oxygen levels in a low target range (oxygen saturation level of 85 to 89 percent) and for the high-oxygen group in a high target range (oxygen saturation level of 91 to 95 percent). The researchers then measured the impact of the two target ranges of oxygen levels for premature babies – specifically, whether infants in one group were more likely to die, suffer brain damage, or develop an eye disease called retinopathy of prematurity and blindness in comparison to the other group."
If the study itself is not concerning enough, the behavior of the Department of Health and Human Services has raised additional concerns. Back in 2013, the HHS' own ethics body raised significant concerns about the study and found that the study's consent forms violated government rules which have been designed to protect human subjects. "According to HHS Office for Human Research Protections, the consent forms "failed to describe the reasonably foreseeable risks of blindness, neurological damage and death" to human subjects in the study." HHS has since attempted to marginalize the ethics board and has even gone so far as to attempt to transfer the ethics review to the National Institutes of Health, which was responsible for the study in the first place. To date, no action has been taken by the federal government to rectify the concerns.
Where is the Outrage?
Although this study may have caused blindness, permanent neurological damage, and even deaths — the mainstream media has absolutely ignored the story. As detailed by award-winning journalist in a recent article published at The Daily Signal, Sharyl Attkisson, many parents who had children in the study neither realized the true nature of the study nor understood the actual risks associated with the controversial study.
SUPPORT, which stands for "Surfactant, Positive Airway Pressure, and Pulse Oximetry Randomized Trial" was promoted by medical personnel at the University of Alabama to Sharrissa Cook, who had an infant in the study, as "a support group who would pretty much hold my hand through the developmental process."
After the results of the study were published in the New England Journal of Medicine in May 2010, many companion studies in other countries were immediately terminated. The results indicated infants in the lower target range of oxygenation group "resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors."
This story should be a sobering reminder of some institutions' propensity to place greater value on avoiding accountability and prolonging deception rather than harboring an unconditional regard for human life, especially that of a baby. Imagine how you would feel if you were one of the parents who unknowingly consented to this study. In hindsight, your baby may have faced a premature death due to the reckless and inhumane irresponsibility of an agency supposedly designed to help enhance and preserve human life. Sadly, many parents don't have to imagine this possibility as they are now reckoning with such a heartbreaking and inflammatory reality.
Image Credit: Huffington Post