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 How the EU proposes to get more children on drugs Minimize
Location: BlogsHappy Healthy Children    
Posted by: richard Thu, 13 Dec 2007 21:42:21 GMT

We are told new legislation by the European parliament will improve the regulation of drug treatment for children, says a child health expert in this week's British Medical Journal.

Over the past ten years, studies have shown widespread use of unlicensed and off-label drugs to treat children, writes Professor Imti Choonara from the University of Nottingham. What a surprise?

In 1999, concerns were raised about children in Europe receiving unlicensed or off-label drugs instead of ones that have been scientifically evaluated and licensed. So in December 2006, the European parliament passed legislation to ensure that drugs used for children are subject to high quality research. Would anyone know the difference. 

It will also provide better data on the benefits and harms of drugs used in infants and children, without subjecting children to unnecessary clinical trials and without slowing down the introduction of new drugs for adults. I wonder will this include vaccines. No they are safe anyway and do not need so much testing.

The legislation provides considerable financial incentives for the drug industry to study drugs in children. However, the author points out that experience in the United States has shown that the drug industry is more likely to study drugs that are prescribed extensively in adults and generate the most profit than those that infants and children require clinically.

A European register of clinical trials of drugs for children will also be established and the results submitted to the regulatory agency will be made public. This transparency is essential, says the author, if it is to benefit children in Europe. Personally I would take Dr Mendelsohns advice "How to bring up a health child inspite of your doctor"

Hopefully the new legislation will stimulate scientific interest in the study of drugs in children and increase the number of paediatric clinical pharmacologists in Europe, Is that a good thing???

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