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Outrage of the Month: Unethical Studies on Premature Babies

Health Letter, May 2013

By Sidney M. Wolfe, M.D.


If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

Last month, Public Citizen sent a letter to the Department of Health and Human Services (HHS) requesting the details of seven new HHS-funded research studies about which we have serious ethical concerns and which are scheduled to involve 4,500 infants. These concerns derive from a previous study that has recently made front-page news, also funded by HHS and implemented by the same group of academic medical researchers.

Public Citizen first exposed the details of an unethical, HHS-funded medical experiment on premature babies that put them at risk of blindness or death without any semblance of adequate informed consent by their parents. Known as the SUPPORT trial, the study involved randomly assigning 1,300 very premature infants to one of two experimental groups. Researchers tried to keep blood oxygen levels in a higher range for one group and a lower range for the other. Depending on the group to which a baby was assigned, he or she faced substantial risks of blindness, brain injury and death, but parents were not adequately warned of any such risks.

The SUPPORT trial was implemented by 23 prominent research facilities throughout the country, including the Stanford University School of Medicine, Yale University School of Medicine, Brown University, Duke University and University of Alabama at Birmingham, all part of the Neonatal Research Network (NRN) established by the National Institutes of Health (NIH) in 1986.

We wrote to HHS Secretary Kathleen Sebelius, asking her to apologize to each of the parents involved and to inform them of the risks, about which they had never been told.

We later learned that at least seven newer NRN randomized trials involving newborns, also funded by NIH, are either ongoing or about to begin. These studies, expected to involve 4,500 infants, include testing experimental anemia treatments using blood transfusions in extremely premature infants, and examining the safety and effectiveness of cooling the body (hypothermia) for 72 hours in premature infants who had moderate-to-severe brain injury at birth.

In most of these studies, the likelihood of death is one of the primary outcomes being measured.

A forthcoming issue of Health Letter will feature a much longer article explaining further details about all of these experiments, as well as the subsequent actions that we have taken.