| Author (Person) | Smith, Diana |
|---|---|
| Series Title | European Voice |
| Series Details | Vol.10, No.13, 15.4.04 |
| Publication Date | 15/04/2004 |
| Content Type | News |
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By Diana Smith Date: 15/04/04 MORE than 50% of medicines used to treat children have not been tested for use in this age group, according to the European Commission. To remedy this, the enterprise directorate-general is drafting legislation on medicinal products for paediatric use. When medicines are developed and tested, they are most often tested on adults. Unfortunately, that means that doctors do not know exactly how the drugs will work on children. Doctors prescribe smaller doses to correspond with a child's smaller body size, but even so, drugs may not work in quite the same way. Enterprise Commissioner Erkki Liikanen first called for action on medicines for children in March 2002. He said that more research was needed for cancer, AIDS and asthma treatments adapted to children. "Children, and especially toddlers, are not just small adults when it comes to medicine," he said. The plan's final consultation process closed last week (9 April), and it is expected that Liikanen's legislative initiative 'Better medicines for children' will be put to the European Parliament before the summer. The need for action has been highlighted by recent disclosures that the anti-depressant Seroxat could cause young people under 18 to kill or harm themselves. In June 2003, the Medicines and Healthcare products Regulatory Agency (MHRA), which licenses the GlaxoSmithKline drug in the UK, announced that previously unreleased clinical trials showed that not only was Seroxat ineffective in children, but that a bigger proportion of those taking it in the trials thought about killing themselves than among those on placebo. Britain's department of health moved quickly to ban the use of Seroxat in respect of children. The proposed EU legislation may help avoid a similar situation occurring in the future. It is likely to draw heavily on the experience in the US, where recent paediatric studies conducted in response to American legislation have led to 64 labels containing new paediatric information for established medicines during the past six years. The European Commission reports that two-thirds of the new labels included important new dosing, efficacy or safety information for use of the medicines in children. US legislation introduced in the late 1990s requires companies to follow the 'paediatric rule' and the 'paediatric exclusivity' provision. The former requires companies to perform paediatric studies or to develop formulations for new and already marketed products if they are likely to be widely used in the treatment of children. The latter creates incentives for companies who perform clinical studies in the paediatric population. The Commission acknowledges the ethical concerns about conducting trials among children, but argues that they need to be balanced against the risks of giving medicines to a population in which the drugs have not been tested. In addition, specific requirements to protect children who take part are included in the new EU directive on clinical trials. The response to the Commission plans has mainly been positive. For example, the European Federation of Pharmaceutical Industries Associations and paediatricians specializing in cancer have broadly welcomed the move. However, Anita Hardon, scientific director of the Amsterdam School for Social Science Research and co-author of Medicines out of control? Antidepressants and the Conspiracy of Goodwill, says that what is really needed to make all drugs safer is greater transparency. "The problem with Seroxat and children could have been signalled much earlier if researchers had access to registration files," she says. Regulatory authorities face "files metres high" and the government must decide what needs checking. "Often one is reliant on the summaries made by the companies," she adds, "and this puts too much emphasis on the positive side of medicines and doesn't pay enough attention to the risks." Hardon says GlaxoSmithKline is not to blame for the problem over Seroxat use in children. Officially, antidepressants are not marketed for use in patients under 18 years of age. But she does say that the company could have done more to send a warning message to the outside world that children should never start using these pills. "Research data remain mostly secret ...because of the enormous commercial interests of the companies," she says.
The European Commission is drafting legislation on medicinal products for paediatric use. The Commission believes that over half of medicines used to treat children have not been tested for use in this age group. |
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| Source Link | http://www.european-voice.com/ |
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| Subject Categories | Business and Industry, Geography |
