A parent's paradox

Being a parent must be the toughest job in the world.

There can be few parents who would not put their child's safety ahead of their own, particularly in a risk-averse society that sees danger lurking round every corner.

Protecting a healthy child is hard enough, but what should parents do when their child is sick - and not just with a minor ailment but with a life-threatening disease?

Herein lies the paradox. An increasing number of mothers are prepared to put their child at risk of contracting diseases that are potentially fatal or capable of causing permanent disability rather than consent to immunisation because of a perceived but unproven risk that the vaccine may cause harm. And even if there were evidence of a link between vaccination and autism or Crohn's, the risk would be far outweighed by the threat posed by mumps, measles or rubella.

But if a child is seriously ill, the parents' attitude to risk shows a marked shift when faced with their child's suffering. It is estimated that around 40% of medicines prescribed to children have only ever been tested on adults; and for newborn babies the figure is 65%. In addition, doctors may prescribe 'off label', where the drug may be licensed for use in children but is being prescribed for conditions not covered by the licence.

Without clinical trials in the child patient population, the doctor is at best making an informed guess about what to prescribe and what the dose should be for optimum effectiveness.

Most clinical trials are carried out on adult patients because they can understand the risks and potential benefits and can monitor their body's reactions. But it is easy to see a parent's dilemma when faced with a choice of exposing their child to an untested drug with unknown side-effects or consenting to the trial in the knowledge that the child may receive only placebo, allowing the disease to progress unchecked.

Last month, the UK government called for more research to be carried out into drugs that are given to children. To back this up, part of the £100m research funding announced in the Budget will be allocated to promote research into drugs for children through new networks co-ordinated by the UK Clinical Research Collaboration. A European Regulation is also being formulated that will encourage companies to develop medicines specifically for children, but this is not likely to be adopted until 2006.

Recent publicity over the prescribing of SSRIs to adolescents has brought paediatric medicines into the public arena, and pharma companies have been sent a strong message, both by parents and by the UK government.

It is one they should heed. After all, they will be investing - quite literally - in the future.