Ethically Sound: Safeguarding Children

Host:

We can all agree that the safety of our children is paramount. So how can we best protect children in the event of a bioterror attack? Welcome to Ethically Sound: A podcast of the Presidential Commission for the Study of Bioethical Issues. I’m Hillary Wicai Viers.

Today we’re speaking with Commission Member Col. Nelson Michael, Director of the U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research. But we’ll begin with a word from Dr. Suzet McKinney, Executive Director at the Illinois Medical District Commission.

Dr. McKinney:

My public health training taught me that vaccinations were good; a safe, reliable and effective preventive measure. Why wouldn’t parents want to protect their children from preventable diseases through vaccination? When the H1N1 pandemic flu broke out in the fall of 2009, we saw children get hit hardest in Chicago. This outbreak garnered widespread media attention locally, nationally and internationally. Despite this very obvious and real threat, many parents chose not to vaccinate their children. This was particularly true in African American, Hispanic and low-income communities where mistrust of the vaccine, and the government’s intent in administering it, was especially high. Our efforts to be communicative were ineffective in relieving parental concern about the safety of the vaccine, as well as what our intentions were in terms of securing full participation in the vaccination effort.

Over the years, I have learned how much stigma and mistrust impact parental perceptions and decisions about vaccines.

If there were an anthrax bioterrorism attack in the US and the government determined a need to immunize children with a vaccine that had not been tested and deemed safe, experience tells me that even the most aggressive and comprehensive efforts to educate parents about the risks and potential benefits will be met with anxiety, fear, protest, and apprehension. Aggressive community engagement efforts will be critical. I’m a believer in vaccines, but even I would have difficulty agreeing to an untested anthrax vaccine for my own child in the absence of a real, credible threat of attack.

Host:

That was Dr. Suzet McKinney, Executive Director at the Illinois Medical District Commission.

While a vaccine for protection against anthrax has been in commercial production for more than four decades, its effects on children are unknown. Should we conduct clinical trials of the anthrax vaccine with children in case of attack? Or should we wait and see if an attack ever happens before testing the vaccine? This was just one of the ethical issues facing the Bioethics Commission during its eight-year tenure.

Dark Zephyr was a bioterrorism preparedness exercise that the government carried out in San Francisco in 2011. The goal was to test local, state, and federal government responses to a large-scale anthrax release. In the exercise, nearly 8 million people were exposed to anthrax, a quarter of them were children.

While the protocol for protecting those exposed to anthrax involved administering an anthrax vaccine in combination with antibiotics, it quickly became clear that while first responders knew what to do for exposed adults, there was no clear course of action for treating children. The anthrax vaccine had not been tested in children. The only options for the first responders involved in the practice exercise were to give children an adult dose of the vaccine, guess at what dose to give, or give no vaccine at all.

The National Biodefense Science Board recommended that the U.S. government test the safety and effectiveness of the anthrax vaccine for children before an anthrax attack occurs, pending ethical review. Health and Human Services Secretary Kathleen Sebelius called on the Bioethics Commission for that thorough ethical review.

In 2012, the Bioethics Commission recommended that, before a bioterrorism attack occurs, scientists should complete all prior ethically sound testing—such as computer modeling, testing with animals, and testing with the youngest adults—to assess the likely level of risk when conducting trials with children. If the risk is found to be minimal, only then should testing with children be employed, beginning with the oldest children first and then progressing younger and younger if risks remain low. This process is known as age de-escalation.

The Bioethics Commission also recommended that research protocols be put in place so that other untested or minimally tested medical countermeasures used to protect children can be quickly tested in an emergency situation.

You can download the report Safeguarding Children, and all the Commission’s reports at bioethics.gov.

I’m joined today by Col. Nelson Michael, Director of the U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research and member of the Bioethics Commission.

Welcome Colonel Michael, thank you for being here.

Colonel Michael:

Well, it’s wonderful to be here, and I look forward to further discussions about some of the great work we did in the past seven years on the Commission.

Host:

How do you think your military background and day-to- day work in vaccine research prepared you for this discussion?

Colonel Michael:

Well, that’s a great question. I have to tell you, in my 26 years in the Army, I’ve been on both ends of vaccination. Because I’m a soldier, I’ve been vaccinated many, many times. And in fact, when I deployed to the Middle East, I received the anthrax vaccine that all soldiers that deployed to that part of the world have to have by Army regulation. I also have spent those past 26 years working on a vaccine for HIV and more recently, on vaccines for Ebola, Zika, and MERS- CoV. So, I’m a vaccine researcher, but also a soldier, so this was a very exciting topic for me because it really fit so well both personally and professionally into what I’ve done with the Army.

Host:

What was most challenging about this ethical analysis?

Colonel Michael:

Research with children is ethically different from research with other groups, especially when the research in question promises really no direct prospect of benefit for the participants. This was really the heart of our matter, whereas competent adults can volunteer and give their consent and can accept risks and benefits for doing research, children really can’t do that legally or ethically. And as a consequence, that really posed lots of dilemmas for us as a deliberative group.

And then lastly, conducting such research before an Anthrax attack actually occurred, would involve testing children with a hypothetical condition. It really puts the whole risk benefit question on top of its head. So, no child today for example, is suffering from inhalational weaponized form of anthrax. So, therefore, there is no real prospect of direct benefit for a participant in a trial looking at countermeasures. Now while the knowledge gained can be profoundly useful in the event of an attack, we may never have such an attack. We hope never to have it or the occasion to use such a countermeasure. So, these were really important pillars of our discussion.

Host:

The Commission issued recommendations for both pre- and post-event research. Why was it important to look at both?

Colonel Michael:

So, to get more granular, pediatric countermeasure research that would take place before an attack occurred is ethically distinct from research that would take place after you’ve established an attack has occurred. We had to take into account, for example, that before an attack occurs, there is an absence of immediate threat to a potential child participant being in the study and that participant’s well-being. Children involved in any pre-event study would be healthy children, no previous or current exposure to anthrax, or frankly a reason to expect them to be exposed in the future without compelling evidence to the contrary.

So, the Bioethics Commission had to consider the ethical and the logistical challenges of conducting research in the aftermath of an attack, when families would be likely geographically separated, kids at school, parents at work. There would be great urgency to distribute treatment and emergency interventions, and as we learned from the recent Ebola situation in West Africa, in some cases, the dynamic and the pace of the discussion really gets driven by a lot of hysteria and fear.

So for pre-event [research], individual children would be enrolled in pre-event countermeasure research that those children would not stand to directly benefit from that research. Thus, the Bioethics Commission concluded that absent extraordinary circumstances, pre-event research with children would be ethical only if it presented no more than minimal risk to study participants. So, what’s minimal? Minimal means no greater risk than routinely faced, for example, by a healthy child in daily life or during a routine medical check-up. If, however, the risk level for the youngest adult, say 18 to 20 year-old is determined to be minimal, then we recommended that testing the next youngest group or older children, ages for example 16 to 17, then progressing in small increments with testing younger and younger children. So, sometimes this is called by vaccine people age de-escalation, beginning with the older children, working your way down to younger children a year or two at a time.

Post-event planning for a post-event research in an emergency situation after an attack is extremely important. Our commission recommended that post-event research be planned for and conducted either untested or with minimally tested countermeasures that are used to protect children in an emergency situation. And in addition, we recommended that if children receive untested countermeasures in an emergency, in an effort to save lives, that rigorous research protections be put into place.

Host:

How did the different expertise and perspectives of the Commission inform the discussion?

Colonel Michael:

The Bioethics Commission consists of members really with a very diverse set of insights including patient advocacy, experts in medicine, law, philosophy, and theology. And one of my greatest delights in serving on the Commission for so long was being exposed to commissioners with really very, very, very different expertise and insights into asking the same question. So, thus, to inform our recommendations, the Commission also heard diverse perspectives from public health experts, ethicists, pediatric research scholars, and effective community members such as the first responder community who will be most likely to be exposed in a terrorist attack.

Host:

What has resulted from the Bioethics Commission’s recommendations?

Colonel Michael:

So, after the release of our report, the Biomedical Advanced Research and Development Authority, or BARDA, and the Centers for Disease Control and Prevention, CDC, conducted a study that set the stage for the use of informed, aged de-escalation with pediatric research participants. The uptake of the Bioethics Commission’s recommendations demonstrated that public health deliberation can be an effective process for finding a reasonable way forward on some of the most morally controversial and difficult science policy questions that our society faces.

Host:

Col. Michael, thanks for being with us today.

Colonel Michael:

Thanks so much, Hillary.

Host:

You’ve been listening to Ethically Sound: A podcast of the Presidential Commission for the Study of Bioethical Issues. Thank you for joining us. You can check out our full series online at bioethics.gov.