Hospital Corpsman 1st Class David Cano prepares a syringe with the anthrax vaccine for a sailor aboard the Nimitz-class aircraft carrier USS George Washington.
(Photo: Justin E. Yarborough, U.S. Navy)
Dan Vergano, USA TODAY
Children should enter clinical trials for anthrax vaccines or other bioterror treatments only if safety experiments pose "minimal risk" no worse than a checkup at the doctor's office, suggests a presidential medical ethics commission.
In a report released Tuesday, the President's Bioethics Commission looked into the ethics of testing vaccines against potential bioterror agents for their safety and effectiveness in children. A biodefense panel had recommended such tests after a 2011 federal mock exercise of an anthrax attack on San Francisco had concluded that 8 million people would be affected, with a quarter of them children.
"Research involving children is ethically distinct from research on adults," says commission chairwoman Amy Gutmann. Morally and legally, children cannot give consent to volunteer for medical experiments, she says. At the same time, biodefense officials worry that without testing of these treatments, doctors will not know if they are giving safe or effective doses of them to kids should a bioterror event occur.
"It is a rock-and-a-hard-place decision. We need to test these treatments to know if they will work, but there are serious questions to consider before doing that sort of testing in children," says pediatrician Steven Krug, chairman of the American Academy of Pediatrics' disaster preparedness advisory council. The federal government stockpiles large amounts of treatments for biological, chemical, radiation or nuclear attacks, Krug says, "and a high percentage of them haven't been tested at all for how they should be given to children."
The report says any clinical trials of treatments such as the anthrax vaccine in children need to show a lack of serious side effects in animals and adults. Other hurdles beyond parental permission and "meaningful" assent by tested children include:
- First testing in older teens ages 16-17, who most likely resemble adults, before moving on to younger kids.
- Under "extraordinary circumstances" of concern about a potential attack, where minimal risks can't be assured, tests could be conducted following a national review that ensures risks are roughly equal to a chest X-ray.
- Money should be set aside to compensate teens or children who suffer side effects of the experiments.
The anthrax vaccine has already been tested in millions of young adults in the armed services without significant side effects, and the report first calls for additional study of 18-year-olds among those servicemembers to see if they report any problems. (Much of the impetus for Defense Department vaccinations came from concerns about biological weapons in the 2003 Iraq War and the anthrax mailings that killed five people in 2001.)
The report also lays out a framework for conducting clinical trials on such treatments in kids after a bioterrorist attack, when doctors will be rushing to provide post-disaster treatment. The ethics of such clinical trials change following an attack, the report says, when children have been exposed to a bioterror agent and stand to directly benefit from treatment. "Anytime that a child has to take an additional risk for no direct benefit is an extraordinary circumstance," Gutmann says.
A decision about whether to proceed with such clinical trials now rests with Secretary of Health and Human Services Kathleen Sebelius, who requested the bioethics report last year.
"The safety and security of our children is a top priority," HHS spokesman Tait Sye said in a statement, which added that the agency would review the report.
"I agree with the framework that the panel has proposed, but just from my own personal view as a pediatrician, I would really like to know how to give these treatments effectively to kids if there is, God forbid, an attack or a disaster," Krug says. He notes that increased resistance to vaccinations among some parents complicates decision-making about proceeding with such trials to test treatments for largely hypothetical threats. "Anthrax has been used before at least once, and it is clearly a real worry in the view of the government, so these are hard decisions we need to discuss now, not when it's too late."