eNews Commentary • Jun 2014 • Storing and Using Newborn DNA—Without Parent Consent • Human Subjects Research • Patient Privacy

Babies Die from Federal Medical Experiments

 


June 4, 2014
 
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Federal officials are defending an unconscionable act. Between 2005 and 2009, the National Institutes of Health (NIH) supported research on 1,316 premature newborns without requiring parents to be told their baby could die and the baby’s oxygen monitor would not show their child’s true oxygen level -- a violation of their own ethics rules, reports Sharyl Attkisson at The Daily Signal.
 
The experiment was carried out on premature infants at 22 sites. The purpose: to determine how much supplemental oxygen premies should receive. According to NIH, 28,000 premies are born each year out of 3.9 million births, with 14,000 – 16,000 of them experiencing vision loss due to supplemental oxygen, of which 90% experience no permanent damage and 400-600 babies become legally blind.
 
The $20 million research was funded by taxpayers through NIH’s Neonatal Research Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development -- the same entity now funding development of controversial genomic sequencing for newborn screening.
 
Babies died. The researchers reported, “one additional death for approximately every two cases of severe retinopathy that are prevented.” They discovered that premies with oxygen saturation levels of 85 – 89% were less likely to experience vision impairment but more likely to die (19.9% vs. 16.2%). Premies with oxygen levels at 91 – 95% were more likely to live, but the survivors were more likely to experience severe vision loss due to higher oxygen levels (17.9% vs. 8/6%).
 
NIH officials say, “The increased risk of death was a significant and unexpected finding of the study.” But it wasn’t. In their findings, the researchers discuss a 1950s study, which demonstrated a 4.9% increase in infant mortality with oxygen restrictions. Yet the recent study’s parent consent form simply said,
 
“The babies in the lower range group will have a target saturation of 85-89%, while the babies in the higher range group will have a target saturation of 91-95%. All of these saturations are considered normal ranges for premature infants.” [emphasis added]
 
In March 2013 the federal HHS Office for Human Research Protections (OHRP) found the “researchers failed to provide prospective parents sufficient information about the risks posed by the study.” The NIH disagreed, arguing [my response in brackets]:
 
  • “When the study began, targeting an oxygen-saturation range of 85 – 95% was becoming standard clinical practice.” [not standard yet]
  • “The researchers had no reason to foresee that infants in one study group would have a higher risk of death than would those in the other group.” [1950s study gave reason]
  • The care of babies included in the experiment “was never compromised for the sake of the study.” [parents disagree]
 
Public Citizen and nine scholars recently called for an investigation of NIH interference with OHRP’s investigation.
 
Researchers prefer uninformed research subjects. Several doctors write, “We are dismayed by the response of the OHRP and consider the … trial a model of how to make medical progress.” The NIH writes, “…the outcome of this debate could affect how we conduct and communicate about critical research on interventions that are within the standard of care for all diseases and conditions.” Indeed it should!
 
Standards of care are often in dispute and….there are no standardized patients. If simply using a “standard of care” becomes the criteria for not fully informing  prospective subjects of research, it’s open season on all patients.
 
No medical experiments on children should be allowed without fully informed written parent consent. But even then, experimentation on a child should leave us quite uncomfortable. Your tax-deductible donation of $25, $50 or $100 today will help CCHF protect children from unconsented research. Please give generously.
 
Working with you to protect babies and parent rights, 
 
Twila Brase, RN, PHN
President and Co-founder