No Ethics? No Problem: The Sequel

Coach is Right ^ | 7/2/14 | Michael D. Shaw

[Oldpuppymax]

A few weeks ago, this column ran a story exposing just a few of the shocking ethics violations that occurred in conjunction with a clinical trial called SUPPORT (Surfactant, Positive Pressure, and Oxygenation Randomized Trial). The trial’s primary purpose was to examine the efficacy of two experimental strategies for managing oxygen and two strategies of ventilation therapy in extremely premature babies. As noted in the earlier piece, the consent forms left much to be desired. In fact, it is likely that if the risks to the babies were properly outlined, few if any parents would have agreed for their children to have been part of the trial.

The notion of “oxygenation optimization” refers to the supposedly critical trade-off between giving these patients too much or too little oxygen supplementation—measured as percent oxygen saturation, via pulse oximetry. Too much could lead to retinopathy, and too little to brain damage or death. In the trial protocol “lower” was 85-89% and “higher” was 91-95%.

Despite the grandiose nature of this project, costing upwards of $20 million dollars, and the massive ethical lapses, which also included deliberate tweaking of the pulse oximeters to provide false data to the clinical staff, there was virtually no takeaway from the results of the trial. There were, however, 23 more deaths in the lower oxygen group (n=654), compared to the slightly larger higher oxygen group (n=662).

Ironically, as was pointed out by researcher and preemie advocate H. Peter Aleff, this 3.5% of additional deaths is remarkably close to the four percent figure (of increased deaths or serious neurosensory disability in survivors) already known to the Neonatal Oxygenation Prospective Meta-analysis Collaboration group. Aleff, whose own son was premature, and emerged blind from the NICU, adds that the numbers of preemies in the lower oxygen group with brain damage were...