Testing the Anthrax Vaccine in Children

The Obama administration has asked a federal advisory committee, the National Biodefense Science Board, to make recommendations about testing the anthrax vaccine in children. The vaccine has been tested in adults, administered to military personnel, and stockpiled so it can be administered quickly should an attack occur in the US. The Washington Post's Rob Stein reports that a federal simulation of an anthrax attack got federal officials thinking about how to handle children. If an actual attack occurs, would be easier to make the call to vaccinate children if we had already conducted research regarding the vaccine's safety and effectiveness in this population.

Research on children requires extra ethical scrutiny, and one of the issues is how the research subjects can benefit -- directly or indirectly -- from the results of the research. Because we don't know if or when an anthrax attack will occur in the US, it's hard to say that research subjects will get any benefit.

Anthony Robbins, a former director of the US National Vaccine Program who's written for The Pump Handle before (see here, here, and here) has written a piece for ABC News that addresses this issue. He points out that the advisory board and parents considering enrolling their children in an anthrax vaccine study needs to know about the likelihood of an anthrax release in the US in order to fully weigh the risks and benefits -- but Robbins considers it unlikely that parents will have enough information to assess the risk of a release:

Parents offered a slot in the anthrax vaccine trial for their children would have to rely on the same experts who believed there were biological weapon stockpiles in Iraq. In the run-up to the invasion of Iraq, our government intelligence agencies invented a biological weapons threat, imagining Iraqi stockpiles of smallpox virus and anthrax spores; stockpiles that were never found.

Trust dissipated. And when the government launched a public health program to give smallpox vaccine to first responders and military personnel, most of them rejected it. The program floundered.

Civilian public health experts will be little help to parents. They are appropriately wary of saying "Trust me," particularly when it is unlikely that the intelligence agencies will share their information that support the claim that the threat is "credible." Surely they will not allowed to relay classified information to the public.

Can we get beyond our distrust of the intelligence community and meet the needs of public health professionals to explain their decisions to the public? Possibly not, but there may be a way around the problem, a way to find the right group of "volunteer" children.

You want to find the right children to receive experimental injections of the anthrax vaccine? How about the children of people who have the national security clearance required for the government to share with them all the evidence that adds up to a "credible threat?" With that information in hand, these parents would be able to make the choice-an informed decision for their children-that the rest of the public surely cannot.

This is useful reminder that ethical research requires fully informed subjects. Broadly speaking, there are legitimate reasons for keeping information classified -- but we always have to recognize that the benefits of secrecy have costs attached.

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