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May 8, 2013

Public Citizen Report to Secretary of HHS: New Information About Baby Trial Shows It Was Even More Unethical Than Originally Thought

Oxygen Monitors Were Intentionally Miscalibrated to Give Inaccurate Readings; Parents Not Informed of the Dangers Posed by Giving Such Misinformation to Doctors Caring for Premature Babies in the SUPPORT Study

WASHINGTON, D.C. – Oxygen monitors used by doctors in a controversial government experiment involving premature babies were deliberately miscalibrated so that medical personnel caring for the infants would not have accurate information about blood oxygen levels. Due to that and other factors, the premature babies in the experiment were exposed to risks of serious, life-threatening harms, which were not divulged in study consent forms signed by their parents.

These are among the many troubling findings presented in a damning report submitted today to the Secretary of Health and Human Services Kathleen Sebelius by Public Citizen’s Health Research Group and renowned bioethicist Ruth Macklin. The report, based on newly obtained information, highlights the serious dangers that the unethical study, called SUPPORT, posed to the babies enrolled in it.

Most disturbing, as detailed in the report, is that while half of the 22 consent forms for the SUPPORT study mentioned to parents the experimental procedure for intentionally giving medical teams inaccurate information about the babies’ oxygen levels, none of the forms described the impact of this experimental procedure on the babies’ care or the potentially serious risks associated with it. In fact, all the consent forms signed by parents misled them into believing that the oxygen experiment was safe and no different than the usual standard of care.

“Critical information was omitted from the consent forms provided to parents who enrolled their infants in the SUPPORT study,” said Macklin, a professor at Albert Einstein School of Medicine; director of a training program in research ethics sponsored by the National Institutes of Health’s (NIH) Fogarty International Center; and a member of the board of directors and past president of the International Association of Bioethics. “Failure to disclose relevant information about risks in the informed consent process is a violation of research ethics.”

In light of the new information, Public Citizen today again urged Sebelius to immediately suspend enrollment in all ongoing or soon-to-begin clinical trials involving infants being carried out at a group of research institutions that make up the Neonatal Research Network, the same group that conducted the NIH-funded SUPPORT study. Seven such trials expected to involve more than 4,500 infants are currently ongoing. In six of these studies, the likelihood of death is one of the primary outcomes being measured.

These new revelations come in the wake of attempts by the SUPPORT study investigators and others to defend the experiment after Public Citizen publicly criticized it as being unethical because of the failure to disclose to parents of the study babies the experiment’s true purpose, nature and risks, which included brain injury, blindness and death. The study took place at more than 20 research institutions, including Yale University School of Medicine, Stanford University School of Medicine, Brown University and Duke University.

The SUPPORT study involved the random assignment of extremely premature infants to receive different amounts of oxygen. One group of babies was to be maintained at a low-oxygen range (85-89 percent) and one at a high-oxygen range (91-95 percent). The researchers primarily wanted to see if babies were more likely to die (which can occur with low oxygen levels) or suffer retinal damage, which can lead to blindness, if their oxygen levels were high.

Oxygen levels in premature babies are monitored continuously with devices called pulse oximeters. These levels are routinely used to adjust the amount of oxygen given to a premature baby and decide when to intubate the baby (an invasive procedure involving insertion of a tube into the trachea, the main airway leading to the lungs) and start mechanical ventilation (treatment with an artificial breathing machine) or when to extubate the baby (remove the breathing tube) and discontinue mechanical ventilation.

But for babies in the high-oxygen group, the pulse oximeters were altered to read inaccurately low, whereas for the babies in the low-oxygen group, the machines read inaccurately high. For example, when the actual oxygen levels for babies in the low-oxygen group were 85 percent to 89 percent, the study pulse oximeter indicated the level was 88 percent to 92 percent. In contrast, when the actual oxygen levels of babies in the high-oxygen group were 90 percent to 95 percent, the study pulse oximeter indicated the level was 88 percent to 92 percent. Nearly all parents of babies in the study were informed that both the high and low oxygen ranges were within the normal range for treating premature babies. However, the investigators themselves stated in the protocol that the higher oxygen saturation target range was the “more conventional” of the two oxygen saturation target ranges that were to be tested. Furthermore, the exact oxygen target level for a particular infant at any particular time should be based on the baby’s individual medical needs.

The medical teams were allowed to use only these intentionally inaccurate pulse oximeters when caring for babies in the study. However, according to criteria specified in the complete SUPPORT study protocol, oxygen levels played an important role in deciding when to start mechanical ventilation, and conversely when to stop it. By giving the medical teams intentionally inaccurate blood oxygen readings, some babies may have had inappropriate delays in being intubated and started on mechanical ventilation, while others may have had these procedures when they didn’t need them.

Each scenario posed serious risks of harm to the babies. And yet, parents were not informed of these risks in the consent form and in several cases were even informed that “[t]here is no known risk to your baby from monitoring with the pulse oximeters used for this study.”

“The combined experimental procedure of randomly assigning babies to low- or high- target oxygen levels, regardless of their individual and frequently changing needs, and giving intentionally inaccurate information about critical data – blood oxygen levels – to the entire medical team, represents a stunning deviation from the usual standard of care for these babies,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group and co-author of the letter to Sebelius. “To not fully explain to parents of babies in this study the nature of this experiment and the inherent risks represented an egregious violation of research ethics.”

In its report, Public Citizen also describes how the SUPPORT study protocol lacked important information that would have been necessary for Institutional Research Boards to determine whether risks to the babies in the study were minimized, a basic requirement of the regulations and ethical principles governing human experiments. Finally, the report responds to arguments made by those defending the study and the adequacy of the consent process.

“Some claim that the criticism of this study will pose a threat to the advancement of medical knowledge and innovation,” Carome said. “However, the real threat to biomedical research is unethical research, which understandably undermines the public’s trust in the motives and conduct of researchers.”

The letter and report are available at  http://www.citizen.org/documents/2124.pdf.

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