15 Apr (AHRP) – 4,500 vulnerable premature babies are being sought as guinea pigs in 7 government-funded experiments being conducted by the National Research Network–the same Network that conducted the lethal oxygen experiment.
In a follow-up to its April 10 letter, Public Citizen has informed HHS Secretary Sebelius that at least 4,500 extremely vulnerable, premature babies are being sought for enrollment in 7 publicly funded experiments whose purpose, protocol design, ethical foundation and risk of death, are of concern. The newly uncovered experiment on NIH’s website–are being conducted by the same National Research Network whose oxygen SUPPORT experiment has been found in gross violation of Federal research standards.
The primary endpoint of the newly uncovered current experiments involving premature infantsis listed as “death or severe disability.” That is an indication that the experiment is NOT designed to improve infants’ survival chances.
(1) Evaluation of Systemic Hypothermia Initiated After 6 Hours of Age in Infants ≥ 36 Weeks Gestation With Hypoxic-Ischemic Encephalopathy: A Bayesian Evaluation (primary endpoints: death or moderate or severe disability).
(2) Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for Extremely Low Birth Weight Infants With Necrotizing Enterocolitis or Isolated Intestinal Perforation (primary endpoints: death or neurodevelopmental impairment).
(3) Optimizing Cooling Strategies at < 6 Hours of Age for Neonatal Hypoxic-Ischemic Encephalopathy (primary endpoints: death or moderate to severe disability).
(4) Ramdomized Controlled Trial of the Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22-26 Months of Age in Intubated Infants < 30 Weeks Gestation Age (primary endpoints: improvement in survival without physiologically defined moderate to severe bronchopulmonary dysplasia, and survival without moderate or severe neurodevelopmental impairment).
(5) Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight Infants (primary endpoint: neurodevelopmental outcome; death is one of the secondary endpoints).
(6) Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to Restrictive Strategy? (primary endpoints: death or significant neurodevelopmental impairment).
(7) A Randomized Trial of Targeted Temperature Management with Whole Body Hypothermia for Moderate and Severe Hypoxic-Ischemic Encephalopathy in Premature Infants 33-35 Weeks Gestational Age (primary endpoints: death or moderate or severe disability).
In light of the evidence disclosed last week about gross ethical and scientific violations in the so-called SUPPORT experiment conducted on more than 1,300 premature babies—without parental informed consent; conducted by the same National Research Network at 23 prominent academic research centers, the newly uncovered 7 neonate experiments should be halted until the protocols and consent forms are independently examined to ensure that human babies are not explited in physiology experiments—as animals have traditionally been.
PUBLIC CITIZEN URGES HHS SECRETARY SEBELIUS TO TAKE ACTION:
(1) Make publicly available on the HHS website all versions of the protocols, sample consent forms and institutional review board-approved consent forms for ongoing clinical trials involving infants being conducted by the Neonatal Research Network, as well as all prior clinical trials conducted by the network since 1986, so that they can be independently assessed by ethicists, researchers, patient advocates and the general public; and
(2) Order the suspension of new enrollment in the ongoing clinical trials until HHS receives confirmation from independent experts that the protocol, consent form content and plan for obtaining consent are adequate and appropriate.
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