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Monday, August 26, 2013

Protect the Helpless: NeOProM Suffocation Protocol for Preemies

Gasping premature babies are being deliberately oxygen starved without parental consent in a macabre on-going experiment called NeOProm, Neonatal Oxygenation Prospective Meta-analysis. Several countries are involved in deliberately targeting premature infants with inadequately low oxygen support that leaves them gasping for air and at higher risk of death from asphyxiation. Parents who have enrolled their babies in these experiments have been denied sufficient information to give informed consent. The babies assigned to the lower oxygen group had a 27% higher risk of death than those in the higher level groups, so, for some, being randomly assigned to that group was a death sentence. Here's a timeline of the experiment from the Medical Observer:
Time line 
  • 2003 The NeOProM (Neonatal Oxygenation Prospective Meta-analysis) Collaboration planned “in response to an emerging trend to use lower and lower saturation targets” in the belief this may prevent broncho-pulmonary dysplasia and retinopathy of prematurity
  • 2005 Recruitment starts for the SUPPORT trial in the US
  • 2006 Recruitment starts for Boost II trials in Australia, NZ and UK
  • Dec 2008 to May 2009 Oximeters in the UK and Australian trials recalibrated after UK investigators found a discrepancy in readings
  • May 2010 SUPPORT trial publishes 27% increased risk of death in lower oxygen saturation group
  • December 2010 BOOST II closes early on advice from Data Monitoring Committees
  • March 2013 US Office of Human Research Protections (OHRP) rules that the Institutional Review Board (IRB) of SUPPORT lead site, University of Alabama in Birmingham (UAB), approved informed consent documents which failed to adequately disclose the risks of the research
  • May 2013 BOOST II publishes results showing among 1187 infants whose treatment used the revised oximeter calibration, the rate of death was 45% higher in the lower-saturation group
  • June 2013 OHRP suspends compliance action against UAB until further guidance on rules on disclosure of risks is produced
  • July 2013 Dr Sidney Wolfe queries why consent forms used in BOOST II have not been investigated by government authorities
  • 28 August 2013 US Department of Health and Human Services public meeting seeking input on research conduct following OHRP’s investigation of SUPPORT
On Wednesday HHS is holding a public meeting in Washington, D.C. According to the Alliance for Human Research Protection:
"The catalyst for the public meeting convened by HHS, be held on Wednesday, August 28, in Washington at the Hubert Humphrey Bldg. 200 Independence Ave, from 9:00 AM to 5:00 PM, is the debate that was ignited by the unethical NIH-funded restricted oxygen experiment (SUPPORT) whose subjects were 1,316 extremely vulnerable premature babies whose supplemental oxygen level was randomly restricted within the confines of the research without regard for their oxygen need for survival--and without a current practice control group thereby impeding safety monitoring of the experimental interventions.... Powerful research stakeholders, led by the director of NIH, are attempting to legitimize experiments such as SUPPORT by declaring that "comparative effectiveness research" (CER) poses no risk greater than "standard of care" should be exempt from federal informed consent requirements. Those who have a financial stake in CER are attempting to secure an escape hatch for experiment they deem to be CER from informed consent disclosure requirements. They know that if the risks were disclosed, no responsible parent would give permission to subject their baby to the risks.
Concerned citizens need to fight these unethical research programs. Government has shown itself time and again to care little about research subjects. Scores of unethical programs taint our history such as the Tuskegee syphilis experiment where poor black sharecroppers were deliberately denied treatment to observe the natural progression of the deadly disease. It seems that same evil mentality of using the poor and helpless for unethical experimentation continues.

You can help stop unethical experiments that target the weak and vulnerable. AHRP urges citizens to:
Send your comments about the need for enforcement of federal research protections before Sept. 9, 2-13. Identify Docket HHS-OPHS-2013-0004!docketBrowser;rpp=25;po=0;D=HHS-OPHS-2013-0004


Laura said...

Please read the Cochrane report on existing knowledge of oxygen and it's effects on neonates before posting. Please note the 10,000 babies blinded by too much oxygen and the 150,000 who dies because we don't understand oxygen yet. The researchers were not trying to kill babies, but save them, preferably without cerebral palsy and chronic lung disease (both current long term effects of too much oxygen). Babies are, quite rightly, an emotive subject. please post responsibly and do your research first.

Mary Ann Kreitzer said...

The first rule of medical studies is not to injure the subjects. Clearly if more babies died from being oxygen starved, they were injured. I don't care what the intent of the researchers was. Blindness and cerebral palsy are certainly not the best outcomes, but I would rather have cerebral palsy or be blind than to be dead. First do no harm!