No Ethics? No Problem: The Story of SUPPORT

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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6 responses to “No Ethics? No Problem: The Story of SUPPORT

  1. Lionell Griffith

    The value of We the People to the government is proportional to the degree we willingly allow ourselves to be sacrificed to the whims of government “officials”. The so called two parties only argue about who to sacrifice to whom, how much, how fast, and for what reason. However, we are to be sacrificed no matter what our founding documents say.

    Do not go quietly into that dark cold night.

  2. Lionell Griffith, the ancient Romans promoted this self-sacrificing attitude with their slogan “dulce et decorum est pro patria mori”, or “it is sweet and glorious to die for one’s country”. The utter nonsense of this slogan has not yet been defeated and it still works its maleficent magic by now sacrificing premature babies to the medical Moloch “for the common good”. The difference is that back then, the victims knew what to expect and were brain-washed to accept it. Today, the sacrificers had to lie to the parents of their victims and therefore omitted any mention of the well-known risks on the consent forms they made them sign.

    Because the experiment was so poorly designed, its only benefit turned out to be the adding of yet another clinical paper in a prestigious journal to the researchers’ resumes, with a price tag to the taxpayer of 20.8 million dollars for that SUPPORT slaughter of 23 “extra” American babies asphyxiated, but still no end to the baby-blinding.

    Michael D. Shaw, thank you for your well-written article about the disdain for ethics at the National Institutes of Health, and also for mentioning the role of fluorescent light in the blinding although the medical community makes every effort to suppress this information. Admitting this obvious and undeniable role of light in damaging the most light-sensitive organ would open a can of worms and get people to ask why nursery doctors are so obstinate in barking up the wrong tree and trying to blame the life-saving oxygen breathing help. For more information about this maintaining the steady stream of captive preemie customers for profitable retinal surgery, see http://retinopathyofprematurity.org/01summary.htm, and for background information about the prior research frauds that led to this latest grotesque experiment, see http://retinopathyofprematurity.org/KnowinglyHarmfulMedicalResearch.htm.

    Another point to emphasize about this SUPPORT suffocating experiment is that the researchers had predicted an increase of four percent for death and severe brain damage in their low-oxygen group. The result they reported was 23 “extra” babies killed in that group, or 3.5 percent. The numbers with brain damage have not been reported and probably never will be.

    This intentional sacrificing of those 23 killed babies meets the U.S. penal code’s definition of premeditated murder. Yet, the Office of Human Research Protection saw nothing wrong with this Mengele-style treatment of human babies as disposable guinea pigs and admonished the SUPPORT researchers only for not having disclosed the well-known risks to the parents to obtain their informed consent. That Office did not address at all the intentional killing which is an even greater violation of all medical “ethics” from the Nuremberg Code on.

    Yet, the Director of the National Institutes of Health interfered with even this feeble criticism and made that only allegedly independent watchdog Office retract its expression of concern. And the Presidential Commission of the Study of Bioethical Issues ignored repeated alerts about the gross abuses by the SUPPORT researchers — no wonder, because the universities led by the Chair and the Vice-Chair of that Commission had actively participated in that willfully patient-harming atrocity.

  3. Michael, the answer to your question is that the U.S. Health system is continuing the inhuman fascist policies for which the Nazi doctors got condemned. The history of the syphilis studies in Guatemala and Tuskegee, the Human Radiation Experiments, plus a long and continuing list of other medical research abuses, up to the most recent one of killing preemies in the SUPPORT suffocation trial, shows that the medical establishment only gives lip service to the various ethics rules established to prevent a return of the Nazi methods. Unfortunately, these methods of sacrificing some humans “for the common good” survive and thrive and are only papered over with hypocrisy.

  4. luisadownunder

    I had a miscarriage at 20 weeks. They are saving babies at 24 weeks. Doesn’t this seem utterly remarkable?
    The amount of care they require is complex and there are no guarantees.

    • Sorry to learn about your miscarriage. Even if your baby had made it to 24 weeks, his or her chance of survival would have been only about 39 percent, with a very high likelihood of severe permanent brain damage and other problems. Moreover, the ability of keeping some preemies alive who would have died several decades ago does not excuse the recklessness of the doctors who blind the babies with excess light and make them deaf with excess noise in their factory-like nurseries and damage their brains by withholding the oxygen breathing help those babies need.

      If doctors used common sense and cared for the well-being of their little patients, they would be able to have many more survivors without major problems. They would also put more effort into preventing miscarriages and preterm births. However, intensive care nurseries are typically the most profitable departments in their hospitals, and the medical community has a financial interest in keeping those incubators occupied.

      Don’t let the “miracle-baby” propaganda hide from you what is really going on!

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