April 15, 2013
Public Citizen to Secretary of HHS: Suspend Enrollment in Baby Trials, Release Details of Ongoing and Earlier Experiments
Call for Transparency Comes Amid Furor Over Unethical Baby Trial Publicized by Public Citizen Last Week
WASHINGTON, D.C. – In light of disturbing revelations last week about a recent unethical trial involving premature babies, the Department of Health and Human Services (HHS) should release details about seven ongoing Neonatal Research Network clinical trials expected to involve more than 4,500 infants, and suspend enrollment in the trials until they are independently assessed by ethicists and others, Public Citizen said today.
Last week, Public Citizen publicized a trial, known as the SUPPORT trial, that involved randomly assigning premature infants to one of two experimental groups. Researchers tried to keep blood oxygen levels in a high range for one group and a low range for the other. Parents were not informed that this experiment involved substantial risks for their babies, including increased risk of blindness, brain injury and death, depending on which group the babies were in.
The SUPPORT study was funded by the National Institutes of Health (NIH) and conducted between 2005 and 2009 at 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. These institutions are part of the Neonatal Research Network, which was established by NIH in 1986.
At least seven Neonatal Research Network randomized trials involving newborns and funded by NIH are ongoing or about to begin. The total planned enrollment for these seven studies is more than 4,500 newborn infants. They are designed to test, for example, a) different experimental strategies for treating anemia with blood transfusions in extremely premature infants; and b) the safety and effectiveness of cooling the body (hypothermia) for 72 hours in premature infants who have moderate to severe brain injury at birth. In most of these studies, the likelihood of death is one of the primary outcomes being measured.
Today, in a letter to HHS Secretary Kathleen Sebelius, Public Citizen called on the government to:
(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.
“Given the egregious deficiencies identified in the consent forms for the SUPPORT study, there is sufficient reason for the public to seriously doubt whether adequate and appropriate informed consent will be or was obtained from the parents of all newborn infants enrolling in these newer ongoing interventional trials,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Indeed, the public’s confidence in the ethical integrity of human experimentation funded by HHS has been understandably shaken by the revelations about lack of informed consent in the SUPPORT study. The actions we are requesting today would begin the surely lengthy process of restoring this confidence. If Secretary Sebelius refuses to take these actions, it would only heighten the concern millions of people in this country now have about the ethical integrity of HHS-funded trials.”