The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

What are Medical Countermeasures?

The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) recently published a report, Safeguarding Children: Pediatric Medical Countermeasure Research, addressing the ethical considerations in conducting clinical trials of medical countermeasures (MCMs) with children. The Bioethics Commission received its charge for this report from the U.S. Department of Health and Human Services Secretary, Kathleen Sebelius, whose offices is “responsible for developing and stockpiling safe and effective [MCMs] to protect the nation from bioterror attacks.”

What are MCMs?

In its report, the Bioethics Commission considered MCMs to encompass “U.S. Food and Drug Administration (FDA)-regulated products and interventions used to combat the effects of chemical, biological, radiological, or nuclear (CBRN) events,” one of several varied definitions of MCMs.  Because MCMs can include protections for and responses to many different types of events (e.g., disease, outbreaks, natural disasters, terrorist attacks), various government agencies, policy centers, and legislators have specified the term to reflect the focus of their work.

Some organizations define MCMs very broadly, encompassing a variety of causes of harm, including natural disasters and infectious disease outbreaks such as the 2009 H5N1 influenza virus and the SARS outbreak of 2003.  Others broaden the definition in terms of types of responses to harm.  The White House Office of Science and Technology Policy, for example, employs a broad definition of MCMs, which includes “both biologic and pharmaceutical medical countermeasures (e.g. vaccines, antimicrobials, and antibody preparations), non-pharmaceutical medical countermeasures (e.g. ventilators, devices, personal protective equipment such as face masks and gloves), and public health interventions (e.g. contact and transmission interventions, social distancing, and community shielding) to prevent and mitigate the health effects of biological agents,” some of which are FDA-regulated and some of which are not.

Alternatively, the definition can be narrowed, for example, by specifying the type of response used to prevent and mitigate harm (e.g., pharmaceuticals or public health strategies) or limiting the type of events that might cause the harm in question (e.g., natural events or acts of terrorism).  The Bioethics Commission employed its narrow definition in response to Secretary Sebelius’s charge. The Secretary tasked the Bioethics Commission with conducting “a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures in children” including “the ethical considerations in conducting a pre- and post-event study of AVA PEP [anthrax vaccine absorbed post exposure prophylaxis] in children”—an MCM designed to respond to a terrorism attack. Moreover, Secretary Sebelius specifically referenced “bioterror attacks” in her charge.

The Bioethics Commission adopts a narrow definition for the purposes of this report. The Bioethics Commission’s guidance, however, might be applicable to a wider range of pediatric research.

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This is a space for the members and staff of the 2009 -2017 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.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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