Children are being denied the same rights as adults in the provision of properly tested drugs

Consumers' Association

Lexie McConnell was nine years old when she noticed she had slightly blurred vision. She told her father Art McConnell who took her to the doctor.

The diagnosis was Toxoplasmosis, and the treatment was corticosteroids and antibiotics. Thirty-six hours after the treatment began her face started to swell up. Within five weeks she was dead.

It turned out that there is no formal license for the use of Corticosteroids on children.

Mr McConnell looked up the drugs in a medical textbook and found this stark quote "Safety and efficacy have not been established in children".

'Lack of accountability'

About half the drugs used in paediatric medicine have no formal licence for use on child patients.

They are either licensed for adults and are being used "off-label", or have no license at all.

Mr McConnell said: "Without wanting to be alarmist my child died as a result of a lack of testing and a lack of accountability. And there are other children in this country and other countries who this is happening to."

The problem is that historically once a drug manufacturer is given a license for the use of a particular drug on adults their research stops. It is expensive and difficult to carry out new trials on children.

Dr Trevor Jones, the director general of the Association of the British Pharmaceutical Industry, said: "There are practical and ethical issues involved in testing medicines particularly where infants or babies may be involved. It is simply unethical to carry out experimental studies on babies unless we are convinced it is safe to do so."

The director of the Consumers' Association says this is simply not good enough.

'Rights denied'

"Children are being denied the same rights as adults in the provision of properly tested drugs," Clara Mackay said.

"Parental consent for testing new treatments or procedures with children is understandably an issue of concern. But we are equally concerned that children are being prescribed medicines every day which have not been tested or licensed for such use."

Mr McConnell also concedes that testing is an issue.

"No parent would want their child used in an experiment on drug testing but the point is children are getting drugs all the time and research could be ongoing with sick children," he said.

"Considering the profits - the enormous billions drug companies make - they could be ploughing some of this into further research and testing especially when it comes to children. And think we would save thousands of children's lives worldwide."

The manufacturers say they are not hiding the problem. They point out that they were one of the first to raise the issue.

They say they hope to have an international system for licensing medicines for five different age groups agreed in November.

In the meantime many of the medicines our children are given are being given outside the very system that is designed to protect patients from inappropriate drugs.

The Consumer Association campaign has been backed by the medical charity Action Research.

Action Research paediatrician Dr Mike Shields, of the Queen's University of Belfast, said: "The way that the body gets rid of drugs is very different in children compared with adults.

"We need data that tells us which drugs are safe to use with children and what dose to give them."