Jun 9, 2014 - 12:02:22 AM (HealthNewsDigest.com) - 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.
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