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Bioethicist: No chance of anthrax vaccine trials in kids

A top-level commission has just released a new report on the morality of studying the safety of an anthrax vaccine in children, with an eye toward treating kids in the event of a terror attack.

The report, issued Tuesday by the Presidential Commission for the Study of Bioethical Issues, is quite thoughtful. It concludes that no testing should be considered unless the risk to kids is minimal. But it also represents a study of an experiment that has no chance of happening -- ever. The commission has wasted its time. There is not a chance that a sufficient number of American parents are going to sign up their kids for the safety testing of an anthrax antidote.

The reasons for asking the question are sound enough: In 2011, the U.S. government conducted a bioterrorism preparedness exercise to study the likely results of a large-scale release of weaponized anthrax spores in a major city Officials estimated nearly 8 million citizens would be affected, nearly a quarter of them children.

If such a terror attack happened, current federal plans call for immediate distribution of antibiotics and a follow-up widespread vaccination program using anthrax vaccine adsorbed or AVA. Vaccination is necessary because anthrax spores would likely pose a threat long after their initial release.

The vaccine has been administered to more than a million adults in the military. The problem, of course, is that no one knows what effect anthrax vaccine might have in children. Some have been in favor of testing the vaccine on children, arguing that it’s better to know the effects than not to know.

The National Biodefense Science Board -- a group of scientists and doctors who advise the feds -- recommended that the government conduct a study to test the safety and effectiveness of anthrax vaccine with children in case an attack occurs, contingent upon ethical review. The new review calls for strictly limiting pediatric anthrax research risk in any study to a minimum.

That sounds reasonable until you think about what a study actually involves. Anthrax vaccination requires five -- count ‘em -- five shots. According to a safety review completed a year ago by the Military Vaccine, or MILVAX, Agency of the US Army Medical Command, 30 percent of men and 60 percent of women in the military who were vaccinated experienced a wide range of minor side effects, including soreness, redness, itching, swelling and or lumps at the injection site, plus ailments like rashes, headaches and joint and muscle aches. There were no deaths or serious long-term harms found.  

As medical interventions go anthrax vaccine is very safe. But it’s one thing if you’re a soldier heading somewhere where bad guys might lob an anthrax-loaded shell your way. In that case, a little itching, swelling and joint soreness would hardly matter.
If it’s your kid, it’s another thing. And if your kid has asthma, allergies, depression, cystic fibrosis or cancer, the risks seem even greater. The whole notion of a trial in children of anthrax vaccine is, quite simply, ludicrous.

Nor should parents want to sign their kids up.  Of all the real challenges that children face -- think abuse, neglect, obesity, suicide -- exposure to anthrax is pretty far down the list.  Calling for this study on kids is to put a remote, tiny risk ahead of a dozen other dismal and all-to-real life-threatening dangers. It is to terrorize kids and parents with a terrorist threat that is remote at best.

The commission sees a small ethical opening through which a study might pass.  I see parents taking one look at any effort to recruit their kids to a safety study of anthrax vaccine and moving on to worry about what their children are eating, who might be bullying them, and whether they drink and drive.  Sometimes you don’t need an ethical review to tell you what is gonna happen.

Arthur Caplan is the head of the Division of Medical Ethics at NYU Langone Medical Center.

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