The blog of the Presidential Commission for the Study of Bioethical Issues

Roundtable Discussion on Medical Countermeasures for Children

The Presidential Commission for the Study of Bioethical Issues has been examining the ethical considerations of conducting clinical trials of medical countermeasures for children. The Commission’s report will explore whether to conduct a pre- and post-event study of an anthrax vaccine as a component of treatment for children exposed to weaponized anthrax.

At today’s meeting, the Commission discussed the ins and outs of research involving children, vulnerable populations and the threat of bio-terror attacks; some of the comments include:

David Resnik, J.D., Ph.D., Bioethicist and IRB Chair, National Institute for Environmental Health Sciences: “What is the social benefit of the research, what is the probability of a terrorist attack, and what is the potential impact? Would there even be a public health benefit if there’s not an adequate supply of countermeasures in place?”

Richard Gorman, M.D., Associate Director for Clinical Research, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases: “Neurontin was used for chronic pain in adults. When we started using it in children it was not effective. The clinical results came back and we had to use it at the same level as adults… We don’t know what we don’t know until we look to see what we can find.”

Neal Halsey, M.D., Professor of International Health, Johns Hopkins Bloomberg School of Public Health: “During the anthrax exposures that took place ten years ago, people didn’t know how long you had to treat people with antibiotics. The thought now is, if you had the vaccine and if someone was exposed you could start the vaccine at the same time so you could eventually end the antibiotics.”

The Commission spent some time considering how to recruit families and who might volunteer for a pediatric anthrax vaccine trial:

Nelson Michael, M.D., Ph.D., Commission member and Director of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research: “Military personnel are considered a vulnerable population, end of discussion. However, I don’t think it will be ethically and intrinsically wrong for military members to be included if they chose to.”

Anita Allen, J.D., Ph.D., Commission member and Henry R. Silverman Professor of Law at the University of Pennsylvania: “Military families are subject to extraordinary pressures on the need to conform and obey; military children are disproportionately separated from their families… Maybe military families are not the best place to go for experimentation.”

Alexander G. Garza, M.D., M.P.H., Commission member and Assistant Secretary for Health Affairs and Chief Medical Officer for the Department of Homeland Security: “After having received the anthrax and smallpox vaccine I can still walk and chew gum at the same time. That being said, we’re talking about two different worlds when we talk about vaccines for influenza and for anthrax. We know a lot about the influenza virus. We don’t know a lot about the anthrax vaccine.”

John Arras, Commission member and Porterfield Professor of Biomedical Ethics at the University of Virginia: “I’m reminded in this context of Hans Jonas’s famous article where he argues that research subjects are best recruited if they are most knowledgeable about the subject and most enthusiastic. We may want to look for volunteers at CDC, NIH, and Ft Detrick.”

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This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

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