5
Nov2013

by Alice Dreger, PhD, Professor of Clinical Medical Humanities and Bioethics at the Feinberg School of Medicine at Northwestern University

The heated debate about the National Institutes of Health- (NIH-) funded Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) continued on October 27 in Atlanta at the annual meeting of the American Society for Bioethics and Humanities (ASBH). Controversy stems from the Office for Human Research Protection’s (OHRP’s) March 2013 determination that the SUPPORT study of interventions on very premature babies was unethical because of failure of informed consent. Following objections from NIH and others, in June OHRP reiterated its findings but pulled back on enforcement and decided to hold a hearing in late August.

In Atlanta, the debate was between Benjamin Wilfond, MD, of the University of Washington and Seattle Children’s Hospital, and Lois Shepherd, JD, of the University of Virginia Schools of Medicine and Law. Earlier this year, Wilfond led a group of bioethicists in a letter to the New England Journal of Medicine (NEJM) demanding that OHRP back off, while Shepherd led a group response insisting that the OHRP press on. Ruth Macklin, PhD, of Albert Einstein College of Medicine and I co-authored the latter NEJM letter. Of particular concern to our group is the lack of description of the trial’s purpose and the conflation of trial enrollment with “standard of care.” This conflation was compounded by a failure to disclose serious risks involved with being randomized into controlled oxygen saturation arms using oximeters that gave readings either several points above or below true (as a blinding procedure).

SUPPORT ultimately showed that babies in the lower oxygen saturation arm (85-89%) were more likely to die compared to those in the upper arm (91-95%). In Atlanta, Wilfond claimed that the researchers could not have foreseen an increased risk of mortality in one of the arms and that is why a possible increased risk of mortality was not disclosed on the consent forms. He and other SUPPORT defenders have lately taken to arguing that mortality was measured only to avoid muddying data collected on Retinopathy of Prematurity (ROP), a condition that takes weeks to develop (and so will not develop if a baby dies very early). This claim contradicts the study protocol and the information provided at ClinicalTrials.gov.

Moreover, Wilfond did not explain why the consent forms also lacked disclosure of possible increased risk of neurological damage and ROP. Shepherd argued that parents were not informed enough to understand the choice they were making between trusting their babies’ doctors’ best judgment or entering this complex trial. The degree to which the consent forms may have caused parents to misunderstand the difference between standard NICU care and care under SUPPORT enrollment became clear at the August hearing, where a mother named Sharissa Cook stunned the audience by explaining that, when she was offered enrollment in “support” for her very premature baby, of course she said yes.

The SUPPORT controversy promises to continue shedding light in many arenas, including the division about the role of advocacy within bioethics, the question of how 23 institutional IRBs involved in SUPPORT failed to catch major deficiencies in the consent forms, and whether the precipitous years’ long decline in OHRP enforcement will persist. The fact that in June the Department of Health and Human Services asked OHRP and NIH to “align” their views on SUPPORT stands as an extraordinary moment in regulatory oversight, or lack thereof. Whether this approach will become standard for federally funded trials remains to be seen.

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