Tuesday, November 25, 2014
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Media confusion reigns over testing Anthrax vaccine in children

Apparently, some people find bioethics as confusing as rocket science. And many of those who are most confused are in the media.

Media confusion reigns over testing Anthrax vaccine in children

Four-year-old Gabriella Diaz sits as registered nurse Charlene Luxcin, right, administers a flu shot at the Whittier Street Health Center in Boston, Mass., Wednesday, Jan. 9, 2013. Boston declared a public health emergency Wednesday as the city tried to deal with a harsh flu season and the state reported 18 flu-related deaths so far. (AP Photo/Charles Krupa)
Four-year-old Gabriella Diaz sits as registered nurse Charlene Luxcin, right, administers a flu shot at the Whittier Street Health Center in Boston, Mass., Wednesday, Jan. 9, 2013. Boston declared a public health emergency Wednesday as the city tried to deal with a harsh flu season and the state reported 18 flu-related deaths so far. (AP Photo/Charles Krupa)

Apparently, some people find bioethics as confusing as rocket science. And many of those who are most confused are in the media.

Last week, a presidential bioethics commission led by University of Pennsylvania President Amy Gutmann declared that the vaccine against anthrax should not be tested in children until its safety it better understood. Amazingly, several press reports had the Commission saying just the opposite. Bioethics seems to have left some in the media quite perplexed. 

The Commission, formally known as the Presidential Commission for the Study of Bioethical Issues, concluded that it is unethical for researchers to expose children to anything more than “minimal risk”, unless they can directly benefit from the research. As a result, until we better understand the anthrax vaccine’s potential for harm, testing in children should be off limits. (Click here to read the full report.)

Why would we even consider conducting such a test? The answer dates back to 2011, when a military exercise code-named Dark Zephyr simulated the effects of an anthrax attack on San Francisco. It estimated that the assault could affect 8 million people, nearly a quarter of whom would be children. 

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Current bioterrorism response plans call for widespread vaccination of civilian populations. But without knowing how children would react, planners have no way to decide whether to include them. A government advisory panel known as the National Biodefense Science Board recommended that we try to find an answer before an attack takes place.

The anthrax vaccine was developed over 40 years ago for use in the military. More than a million members of the armed forces have taken it since then, and experts consider it generally safe. However, it has never been administered to children, who often react to medications differently than adults.

Last year, Health and Human Services Secretary Kathleen Sebelius asked the Commission for advice on whether research to find an answer was ethical. Her charge was a broad one – to consider the ethics of conducting any pediatric research on countermeasures against a bioterrorist attack. 

The Commission’s answer was clear. Unless we can be certain that the research poses no substantial risk to the health or wellbeing of child subjects, it should not done. And if the risk is anything more than minimal - what a child would routinely encounter in daily life or in a medical checkup - it must be subject to extensive national-level review.

How would we know whether the risk were small enough to permit testing? The Commission noted techniques that have been used to study other kinds of medical interventions in children but stopped short of recommending them. And it warned that no testing would be ethical without the full and free informed consent of the parents.

Most of media got the story right. It reported that the Commission’s recommendation would halt any testing of anthrax vaccine in children for the foreseeable future. 

A range of headlines was on the mark. “Panel: Thumbs Down on Anthrax Vaccine Test in Kids” declared this website. The Washington Post proclaimed, “Ethics Panel Sets High Bar for Anthrax Vaccine Research in Children.” And a report on NPR was titled “Bioethics Panel Warns Against Anthrax Vaccine Testing On Kids.”

But others were surprisingly misleading. “Panel Urges Limited Tests of Anthrax Vaccine in Kids” was the headline in USA Today. A story on Reuters was headed “Test of Anthrax Vaccine in Children Gets Tentative OK.” And a report on US News Health ran under the heading “Bioethics Panel Gives Cautious OK to Testing Anthrax Vaccine in Kids.”

Commentaries and opinions based on this misreporting spread across the web. The National Review Online declared with amazement, “President Obama’s bioethics advisory commission has given conditional approval to test anthrax vaccine on children!” The website GlobalPost reported on controversy in the medical world that had been sparked by the panel’s tentative “yes” to testing. And the site Before It's News declared in a headline, “Gov’t Moves to Give Children Deadly Vaccine.”

Is bioethics that difficult to understand?

Commission chair Amy Gutmann called the decision “one of the most difficult ethical reviews that any bioethics commission has ever conducted.” It involves a delicate balance between preparedness for and protection of some of society’s most vulnerable members. “The safety of our children is paramount and we have to get this precisely right,” she declared.

The balance the Commission came up with sets an extraordinarily high bar for testing. It is so high that one prominent bioethicist called such research “an experiment that has no chance of happening – ever.” 

This is not the first time that pronouncements on health care have been twisted beyond recognition. The debates over Obamacare were filled with examples. But it is unusual for the misinformation to be so transparent. 

You don’t have to take my word for it. You can read the report yourself.

Robert I. Field, Ph.D., J.D., M.P.H. Professor, School of Law & Drexel School of Public Health
About this blog

The Field Clinic reports and analyzes health care laws, government policies, and political trends that are transforming the care we receive and the way we pay for it. Read more about our panel of bloggers here.

This blog is produced in partnership with Kaiser Health News, an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health-policy research and communication organization not affiliated with Kaiser Permanente. Portions of this blog may also be found on Inquirer.com and in the Inquirer's Sunday Health Section.

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Robert I. Field, Ph.D., J.D., M.P.H. Professor, School of Law & Drexel School of Public Health
Jeffrey Brenner, MD Founder of the Camden Coalition of Healthcare Providers, Medical Director of the Urban Health Institute at Cooper University Healthcare
Andy Carter President & CEO, The Hospital & Healthsystem Assoc. of Pa.
Robert B. Doherty Senior Vice President of Governmental Affairs & Public Policy American College of Physicians
David Grande, MD, MPA Assistant Professor of Medicine at the University of Pennsylvania
Tine Hansen-Turton Chief Strategy Officer of Public Health Management Corporation
Drew A. Harris, DPM, MPH Director of Health Policy Program at the Jefferson School of Population Health
Antoinette Kraus Director of the Pennsylvania Health Access Network
Laval Miller-Wilson Executive Director of the Pennsylvania Health Law Project
David B. Nash, MD, MBA Founding Dean of the Jefferson School of Population Health
Mark V. Pauly, Ph.D. Professor of Health Care Management, Business Economics and Public Policy at The Wharton School
Howard J. Peterson, MHA Managing Partner of TRG Healthcare, a national healthcare consulting firm
Donald Schwarz, MD, MPH Deputy Mayor for Health & Opportunity and Health Commissioner for the City of Philadelphia
Paula L. Stillman, MD, MBA Healthcare consultant with special expertise in population health and disease management
Elizabeth A. W. Williams Senior Vice President & Chief Communications Officer for Independence Blue Cross
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