Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.

Reuters NewMedia - December 6, 2007
Ben Hirschler

More than half the drugs currently used to treat children in the industrialized world have not been specifically tested on youngsters, even though they metabolize medicines differently to adults.

As a result, clinicians lack clear guidelines on the best drug to use and often have to guess at the correct dose.

The problem is even worse in developing countries where price remains a major barrier and 6 million children die each year from treatable conditions.

In the case of HIV/AIDS, the few existing pediatric therapies developed for children generally cost three times more than adult ones.

In a bid to address the problem, the WHO has drawn up the first international List of Essential Medicines for Children, containing 206 products deemed safe for children that tackle priority conditions.

"But a lot remains to be done. There are priority medicines that have not been adapted for children's use or are not available when needed," said Dr Hans Hogerzeil, the U.N. agency's director of medicines policy and standards.

Medicines that need to be adapted to children's needs include many antibiotics, as well as asthma and pain drugs. The WHO also wants more research and development of combination pills for HIV/AIDS, tuberculosis and malaria.

The agency is building an Internet portal linking to clinical trials carried out in children and will launch a Web site with the information early next year.

Testing medicines on children has always been a vexed issue, since good ethical practice requires informed consent from people participating in clinical trials, which is difficult to obtain in the case of children.

As a result, research-based drug companies have been wary of developing child-friendly medicines and generics companies have been slow to produce them at lower cost.

In an attempt to tackle the issue, both Europe and the United States now have special rules offering extended patent protection for drugs that have been tested on children.

Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers Associations, said such measures were starting to make a difference.

Between 1990 and 1997 only 11 products were studied in children in the United States but in the last 10 years the total has jumped to 125. Research is also picking up in Europe.

GlaxoSmithKline Plc said on Thursday it had won European approval for a new scored-tablet formulation of its combination HIV/AIDS drug Combivir for treating children.

(Editing by Louise Ireland and Quentin Bryar)

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