Health experts have warned that hundreds of young cancer patients are dying because drugs that could save them from the debilitating disease are only tested on adults and European Union (EU) rules are to be blamed.
Under EU rules, pharmaceutical companies have the option not to test new cancer medicines in pediatric trials if the drug is for treatment of cancers that seldom afflict children.
Louis Chesler, a researcher at Britain's Institute for Cancer Research (ICR) and a pediatric oncologist at London's Royal Marsden hospital said that the current system puts children at a disadvantage.
"Many cancer drugs developed for adults could be effective in children if we were able to test them in clinical trials," he said. "But the current system allows drug manufacturers to avoid testing their products in children, on the flawed grounds that adult cancers don't have direct children's equivalents - even where there is a common mechanism of action."
The ICR and the European Consortium for Innovative Therapies for Children with Cancer (ITCC) analyzed the impact of the current system and found that 26 of 28 cancer drugs marketed for adult patients since 2007 have mechanisms that are relevant for pediatric cancers. Unfortunately, 14 of these drugs were exempted from being tested on children because the particular adult condition that the drugs are developed for, does not occur in children.
Health experts from the ICR, international cancer researchers and campaigners are calling for changes in the EU legislation, saying that changing the rules could save or extend many young cancer patients' lives. The current system causes long delays before new life-saving drugs become available for children as well as results in crucial drugs not getting licensed for pediatric use.
"It's essential that ground-breaking cancer treatments are tested not only in adults but also in children, whenever the mechanism of action of the drug suggests they could be effective," said ICR Chief Executive Alan Ashworth. "That requires a change to EU rules, since the current system is failing to provide children with access to new treatments that could add years to their lives."
Around 1600 children are diagnosed with cancer in the U.K. each year and doctors tend to prescribe adult cancer drugs, taking responsibility for using medicines that have not been formally tested on children.
Chesler said changing the rules can have a significant impact. "Increasing the number of pediatric cancer trials can have enormous benefits for children with cancer, by increasing the number of drugs available to them, improving doctors' knowledge about how best to use drugs in children, and providing treatment in a best-practice clinical trial environment." he said.
