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PRESS RELEASE 2-2-15: New in the Hastings Center Report

Ongoing controversy over study with premature infants, and more.

For two years, a debate has raged over the study known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), which sought to gauge the risks and benefits of different blood oxygen levels currently targeted in the care of premature infants. Two articles in the current Hastings Center Report aim to take the debate to a new level. The January-February issue is available for free. 

Were There “Additional Foreseeable Risks” in the SUPPORT Study? Lessons Not Learned from the ARDSnet Clinical Trials

Even though the interventions were drawn from standard clinical practice, the way they were provided meant, Henry J. Silverman and Didier Dreyfuss state, that infants in the study received distinctly different care, with a different risk profile. Parents should have been informed about the differences and given a chance to think them through, argue Silverman, a professor at the University of Maryland School of Medicine, and Dreyfuss, a professor of critical care at Paris-Diderot University.

SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies

The design of SUPPORT has been widely misunderstood, and this confusion has driven much of the debate about the ethics of the trial. John D. Lantos and Chris Feudtner argue that this confusion also threatens the whole enterprise of comparative effectiveness research, which aims to compare two usual or standard treatments to find evidence of which treatment is most effective. Lantos teaches pediatrics at the University of Missouri-Kansas City and directs the Children’s Mercy Hospital Pediatric Bioethics Center, and Feudtner directs the Department of Medical Ethics at the Perelman School of Medicine at the University of Pennsylvania and is the winner of one of the 2014 Hastings Center Cunniff-Dixon Physician Awards.

Three commentaries respond to these articles. They are by Robert Nelson, senior pediatric ethicist at the Food and Drug Administration; Alan R. Fleishman, professor of clinical pediatrics and professor of clinical epidemiology and population health at the Albert Einstein College of Medicine; and Lois Shepherd, who teaches biomedical ethics, public health, and law at the University of Virginia.

Also in this issue:

Case StudyFaith and Futility in the ICU

James, 72, has end-stage dementia and numerous medical problems, including sepsis from multidrug-resistant organisms, respiratory failure requiring ventilary support, and renal insufficiency. Despite his extremely poor prognosis, his only child and closest relative, Paul, is requesting full treatment in the ICU focused on recovery. Paul says he has the gift of prophecy and knows for certain when God is speaking to him. Commentaries are by Annette Mendola, director of clinical ethics and an assistant professor of medicine at the University of Tennessee Medical Center in Knoxville, and Gregory L. Bock, associate professor of philosophy at Walters State Community College.

At Law: Ebola, Quarantine, and the Law

Judged by the key measures of morbidity and mortality, the United States has been very fortunate in the Ebola outbreak so far. But by almost any other measure, the response to Ebola in the U.S. has been a disaster. Among other things, there has been misinformation, politicization of public health, public panic, and unnecessary quarantine. But one often overlooked factor that complicated the response to Ebola is American public health law, writes Mark A. Rothstein, director of the Institute for Bioethics, Health Policy and Law at the University of Louisville.

Policy and Politics: The Regulatory Gap for Preimplantation Genetic Diagnosis

The use of preimplantation genetic diagnosis (PGD) is unregulated in the United States – unlike in nearly all other countries where it is available. The result of this regulatory lacuna is that while PGD was originally intended for screening embryos for severe heritable disorders, it is now also employed for a variety of more controversial purposes, writes Michelle Bayefsky, a postdoctoral fellow in the Department of Bioethics at the National Institutes of Health.