Pediatric vaccine trial receives ethics review
An advisory board to the Department of Health and Human Services (HHS) has recommended that a proposal to hold pediatric trials of the anthrax vaccine be reviewed by an ethics board before proceeding.
The National Biodefense Science Board (NBSB) was formed by HHS in 2006 to consider ways to prevent and respond to potential public health emergencies that might arise from biological, chemical, or nuclear incidents. The board was asked to consider whether trials of the vaccine, which has been used with adults for years, should be conducted with children. The concern of trial proponents is that in the event of a domestic anthrax attack, doctors would have little guidance as to the appropriate doses for children exposed to the pathogen.
"Our job as public health emergency experts and people who deal with preparedness response — disasters, bioterrorism, you name it — is to anticipate the unexpected," said Daniel Fagbuyi, MD, FAAP, medical director of disaster preparedness and emergency management at Children's National Medical Center in Washington, DC, who serves on the NBSB. "While people may be complacent and say that everything is fine, when something happens, the people who criticized planning ahead will be the same ones saying, 'Isn't this your job? You should be anticipating all these kind of things.'"
Opponents of the anthrax trials proposal argue that the likelihood of a domestic anthrax attack that affects children is so small that a child participating in a trial has almost no possibility of benefitting from it.
Paul Offit, MD, chief of the infectious diseases division and director of the Vaccine Education Center at The Children's Hospital of Philadelphia, PA, said, "I don't think you can do a trial on children from which they can't possibly derive benefit." Offit testified before the NBSB on the issue last summer. (For more information on different pediatric vaccine trials, see related story, below.)
Assembling a review board
The NBSB did not specify what board should carry out the review, or if one should be assembled specifically to answer this question. Fagbuyi said a board comprised of ethicists, public health experts, and others representing the interests of children could be gathered to handle the issue.
Fagbuyi said the ethics review also should consider the review board process for any potential pediatric anthrax vaccine trials. "Who's going to be the [institutional review board] IRB of record? Who's going to be responsible?" he said. "There needs to be good dialogue about who's going to take that on. Is it going to be local IRBs, or a national IRB? That's one of the things they're going to have to deal with."
Mark Schreiner, MD, chairman of the Committee for the Protection of Human Subjects at The Children's Hospital of Philadelphia, sees no current medical need for a pediatric anthrax trial. "There is no current threat; it's very much a hypothetical threat," he said. "In order to approve research in children, it has to either be minimal risk, or there has to be only a minor increase above minimal risk, or there has to be the prospect of direct benefit."
In addition to suggesting the ethics review, Ruth Berkelman, MD, director of the Center for Public Health Preparedness and Research at Emory University in Atlanta, GA, also suggested a feasibility study to determine whether any parents would be willing to volunteer their children for anthrax vaccine trials. Fagbuyi said he believes that some populations who might consider themselves uniquely vulnerable in the event of an attack — military personnel, EMS workers, firefighters, etc. — might be more willing to enroll their children in trials.
"It is common knowledge that some military personnel have wondered whether they are in harm's way, with the thought that they don't want to expose their family if they're going to be on the front lines," he said. "There are other populations: those who work in biosafety labs, those who do studies with anthrax, those who work with wool and animal hides. Those are the ones who may be interested in those types of studies."
Resource
- Minutes of the NBSB meeting are available at http://bit.ly/yZsMho.
Pediatric vaccines — a comparison of two Association between anthrax and smallpox vaccines Paul Offit, MD, chief of the infectious diseases division and director of the Vaccine Education Center at The Children's Hospital of Philadelphia, PA, generally argues in favor of pediatric vaccine programs, but he opposed a plan in 2002 to test smallpox vaccines in children when he was a member of the Centers for Disease Control and Prevention's Advisory Committee for Immunization Practices. He discussed his opinions recently in light of the controversial proposal to test an anthrax vaccine on children. "I felt the same thing there — that the chances that a child would be exposed to smallpox were essentially zero, and therefore, it didn't make sense to do that trial." The smallpox trials proposal drew criticism and eventually was scrapped. Offit notes that the anthrax vaccine is much safer than the smallpox vaccine. "The way this [anthrax] vaccine is made is much more similar to the diphtheria and tetanus vaccines," he says. "You take protein that is made by the bacteria and inactivate it. It's going to be a very safe vaccine. So I don't think the children are at any risk, I just don't think those children are likely to have any benefit." Proponents argue that the only alternative to trials is to wait for an attack to occur and then give any children exposed a combination of antibiotics and vaccine. Vaccine dosages would have to be guessed at. Daniel Fagbuyi, MD, FAAP, medical director of disaster preparedness and emergency management at Children's National Medical Center in Washington, DC, says, "We can say to parents, well, we have used it in adults, and that's as much as we have information on, and it's an emergency now. You can either take it or not take it, understanding the risks of mortality with an infection, especially a pulmonary, inhalational kind of infection." At the recent National Biodefense Science Board (NBSB) meeting, the recommendation to seek an ethics review before proceeding with a trial was suggested by Ruth Berkelman, MD, director of the Center for Public Health Preparedness and Research at Emory University in Atlanta. Berkelman says that proponents made their case that vaccine trials would be useful. "We were asked, 'Is there a need for this, did people think it would be helpful to have this information in case there was a wide-scale anthrax event?' And the answer was yes, it would be helpful to have a pre-event trial. At the same time, the ethical considerations in children on this particular issue are quite large," she says. "We don't have ethicists on our board. And I thought this had such a large ethical component to it that it was important that ethicists review this issue." |
An advisory board to the Department of Health and Human Services (HHS) has recommended that a proposal to hold pediatric trials of the anthrax vaccine be reviewed by an ethics board before proceeding.
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