May 17, 2012
Washington, D.C. – As the President’s bioethics commission dove into the issues surrounding how the country should best prepare to respond to its children in a terrorist attack or other large scale disaster, Amy Gutmann, Ph.D., Chair of the Presidential Commission for the Study of Bioethical Issues, welcomed Health and Human Services Secretary Kathleen Sebelius to the Commission’s meeting today.
On Jan. 10 Secretary Sebelius asked the Commission for ethical advice on the development of medical countermeasures for children. Broadly speaking, medical countermeasures are pharmaceutical and non-pharmaceutical products used to prevent the health effects of a chemical, biological, radiological, or nuclear event; large-scale natural disaster; or naturally occurring, emerging infectious disease. The issue garnered substantial public interest last fall when another Federal advisory committee recommended pediatric testing of the anthrax vaccine.
The question that sparked this broad charge from Secretary Sebelius to the Commission is how to treat children who have been exposed to anthrax; it was a question that arose during a Homeland Security exercise. The National Biodefense Science Board (NBSB) recommended testing children before an anthrax event, rather than waiting for a crisis. However, the NBSB also recommended that such testing occur only after the ethical considerations are adequately reviewed and addressed.
“We are carefully and transparently reviewing all of the ethical considerations surrounding the development of medical countermeasures for children,” Gutmann said. “The safety of our children is paramount. It is vital for us to thoroughly address any and all ethical considerations that impact how we treat our children in a time of crisis.”
As she introduced the issue to the Commission, Gutmann clearly outlined the task before the panel, “At issue is the lack of development of appropriate pediatric medical countermeasures that would be needed in a crisis This is not a review of the merits of vaccine research in general.”
Sebelius today told the Commission she trusted the panel to do the job. “The Commission has delivered rational, independent, evidence-based advice on a wide range of complex bioethical issues. And I know I can look forward to receiving the same, when it comes to countermeasures for children.” Secretary Sebelius said as she addressed the Commission.
In her January letter to Gutmann, the Secretary noted that “the development of appropriate medical countermeasures for children lags, in part due to challenges in collecting basic dose and immunogenicity studies in pediatric populations.”
As it examines the ethical issues surrounding research in children, the Commission will build on work it has already done on the issue of protecting human subjects in research. Last year it released a report that assessed the current rules and regulations that protect research participants.
It was this work that prompted the Secretary to turn to the Commission for advice. “From investigating the Public Health Service experiments in Guatemala to assessing the rules that protect human subjects in research today -- the Commission brings transparent, democratic deliberation to some of our most difficult issues. And that is the same approach I have asked you to bring to your examination of the ethical issues surrounding the development of medical countermeasures for children.”
“The Commission is pleased to take up this important issue for the Secretary and we will deliver a report to her and to the White House later this year,” Gutmann said.
In addition to taking up medical countermeasures for children, the Commission continued its inquiry into the pressing privacy and data access issues raised by the emergence of low cost whole genome sequencing. In late March the Commission issued a Request for Public Information and it has been collecting input from scientific, ethics, and patient communities, as well as others, to help inform its deliberations of privacy and access issues raised by the ready availability of large-scale human genome sequence data.
“It is likely that 2012 will be the year that whole genome sequencing will be widely available for less than $1,000,” Gutmann said. “What once cost millions may soon cost less than many standard diagnostic tests today. Advances in science and technology can create a range of ethical dilemmas. This Commission seeks to identify and promote policies and practices that ensure that scientific research, health care delivery, and technological innovation are conducted by the U.S. in a socially and ethically responsible manner.”
The Commission expects to provide President Obama with a report and recommendations on genomics and privacy in the fall.