June 9, 2014
No Ethics? No Problem: The Story of SUPPORT
By Michael D. Shaw
The National Institute of Child Health and Human Development was established by President John F. Kennedy, with the support of Congress, in 1962 to study the “complex process of human development from conception to old age.” In 2007, the NICHD was re-christened to include the name of Eunice Kennedy Shriver. Among NICHD’s many large projects was the so-called SUPPORT study (Surfactant, Positive Pressure, and Oxygenation Randomized Trial).
The results of this study were published in May, 2010 in the New England Journal of Medicine, in an article entitled “Target Ranges of Oxygen Saturation in Extremely Preterm Infants.” According to the final protocol for the clinical trial, its primary purpose was to examine the efficacy of two experimental strategies for managing oxygen and two strategies of ventilation therapy in extremely premature babies.
To this end, 1,316 infants–born between 24 weeks 0 days, and 27 weeks 6 days of gestation–were studied, within institutions belonging to NICHD Neonatal Research Network, from February 2005 to February 2009. The NEJM article set the stage:
“Previous studies have suggested that the incidence of retinopathy [often leading the blindness in preemies] is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes.”
As such, the trial compared target ranges of oxygen saturation of 85 to 89% and 91 to 95%. These oxygen groups were randomly assigned. From the outset, there were two highly unusual aspects of the methodology.
In a puerile, if not unethical and potentially dangerous means to achieve study blinding, the pulse oximeters were electronically altered, to indicate saturation levels of 88 to 92% for both targets of oxygen saturation, with a maximum variation of 3%. As the too-clever-by-half authors explained: “For example, a reading of 90% corresponded to actual levels of oxygen saturation of 87% in the group assigned to lower oxygen saturation (85 to 89%) and 93% in the group assigned to higher oxygen saturation (91 to 95%).”
In other words, the neonatal intensive care unit (NICU) personnel, caring for all of these 1,316 critically ill patients, were unaware of the correct oxygen saturation values–a parameter held to be of vital importance by the authors themselves.
The second unusual aspect of the research is that it lacks a control group! Amazingly, there was not a control group in which the normal standard of care–individually titrated oxygen–could be compared to the experimental groups.
An additional and completely overlooked factor is the growing body of knowledge suggesting that retinopathy of prematurity has a lot more to do with fluorescent lighting than oxygen. Indeed, such lamps emit a strong spike of radiation output at 435.8 nanometers, right in the middle of the wavelength region from 430 to 440 nm, which OSHA has identified as the most retina-damaging in the entire visible spectrum.
Far worse problems than these would soon emerge. In March, 2011, the leaders of the study were contacted by Department of Health and Human Services’ Office of Human Research Protection, directing them to “[E]valuate allegations of noncompliance with HHS regulations for the protection of human research subjects.” This probe would continue, finally resulting in a 13-page letter (March, 2013) from HHS presenting a litany of issues, primarily involving the informed consent process, and significant deficiencies in how the risks were presented to the parents of the premature infants.
Sadly, this would only be the tip of the iceberg. Based on materials obtained under the Freedom of Information Act, Public Citizen, in a lengthy letter to HHS, denounced the consent forms for failing to explain that…
1. The study involved substantial risks, compared to not participating.
2. The level of oxygen a baby received would in many instances be changed from what they would otherwise receive, based on standard of care. Thus, brain injury, blindness, or death might occur.
3. The NICU personnel would be given inaccurate oxygen data.
A truly comprehensive rendering of all that is wrong with the SUPPORT study would fill a dozen articles of this size. As Vera Sharav, President, Alliance for Human Research Protection said in May, 2013:
“The SUPPORT experiment is an example of the worst case of institutional betrayal of trust after the adoption of statutory federal protections. An apology is due to every parent whose infant was enrolled in the SUPPORT experiment. The National Institute of Child and Human Development and the medical center at which each infant was subjected to this illegitimate experiment should apologize.”
Fat chance. Far from apologies, the researchers responded with defiance and denial. On June 4, 2013, HHS would back off from all compliance actions. Too many big names and programs were at stake. Thus vindicated, on the very next day, an unctuous “Perspective” article appeared on NEJM‘s website entitled “In Support of SUPPORT–A View from the NIH.” How ironic that the 1,325 words of this sanctimonious drivel from NIH leadership so closely matches the number of babies in the study. On the brighter side, dogged investigative journalist Sharyl Attkisson has recently brought this matter to the forefront.
Just one more example of how government and health care are a lethal mix.