Forty years ago, dozens of children in the US died of a condition known as grey baby syndrome after taking a new antibiotic. The drug, chloramphenicol, had been used to treat blood infections in adults, but had never been tested on children. Doctors did not realise until too late that children's immature livers were incapable of clearing it from their bodies, and toxic levels quickly built up in their bloodstream.
Astonishingly, children still face similar risks today. The vast majority of drugs have never been tested on children, forcing doctors to prescribe them "off label"-outside the conditions for which they were licensed. They have to gamble on a child being able to cope with the dosage they prescribe. This also means that liability for the outcome rests with them or their health authority, rather than the drugs company.
"Every paediatrician and GP caring for children faces this problem on a daily basis," says Vas Novelli, a consultant in paediatric infectious diseases at Great Ormond Street Hospital in London. "Each is expected to weigh up the pros and cons of using an unlicensed medication, knowing full well that they are taking on the responsibility themselves for any major problems that may occur."
"Recent advances in biomedical research have not been translated into advances in child health," says Tim Westmoreland, a Washington lobbyist working with the Elizabeth Glaser Pediatric Aids Foundation in Santa Monica. "For years, doctors and parents have been put in the untenable position of [either] ignoring drugs that are effective in adults or exposing children to drugs of unknown safety."
In 1997 in Britain, a House of Commons health committee on the needs of
young people expressed astonishment at this situation. Since then, however,
nothing has been done to remedy it. "The present lack of resources and capacity
of the workforce to improve knowledge and practice of paediatric drugs is
nothing short of a natio
Contact: Claire Bowles