Children with cancer are missing out on potentially life-saving drugs due to a loophole in European Union regulation, says a group of cancer researchers, who called for changes to the law this week.
Current laws allow pharmaceutical companies not to trial cancer drugs in children, even if the drug is likely to benefit them, says the Institute for Cancer Research in London and the European Consortium for Innovative Therapies for Children with Cancer.
An estimated 1 in every 500 children in the UK will get cancer by the age of 14. Although these are small groups of patients, it's an emotive issue because these drugs could save children's lives, says Louis Chesler, a paediatric oncologist from the Institute for Cancer Research. "It is disempowering to tell parents a child has to go to palliative care because you don't have any options for them, but if the legislation were different you might."
Waived responsibility
In 2007, the European Union said all drugs developed for adult cancers should be considered for use in paediatric cancers. That's because the vast majority of drugs will target molecules also implicated in childhood cancer. However, pharmaceutical firms can apply for a waiver if the particular cancer the drug is developed for doesn't occur in children – but this doesn't mean the drug won't be useful.
For instance, children do not usually get lung cancer, yet some drugs developed to treat lung cancer in adults target specific genes which go awry in types of cancer that do affect children, says Chesler.
Anecdotes not enough
A survey carried out by the Institute of Cancer Research and others found that 26 of 28 cancer drugs approved for adults since 2007 could be relevant in childhood cancers, but 14 were excluded from trials because of the loophole.
This is an enormous problem, says Pamela Kearns, director of the Cancer Research UK Clinical Trials Unit at the University of Birmingham, UK, and one she sees often with her patients. She says that future regulation needs to focus on the biology of the disease, rather than disease type.
Doctors are allowed to prescribe drugs for conditions that they haven't been trialled for on a case by case basis. But Chesler says that in practise, most clinicians wouldn't be comfortable prescribing drugs "off label" outside the framework of proper trials, unless there were firm data to support it. "The problem with this anecdotal approach is that then we never develop proper data to show that the drugs are safe or effective in proper trials and no one benefits from that," he says.
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