CANCER
Kids denied cancer drugs under EU rules
February 11, 2014
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EU rules are denying children with cancer the chance to access potentially life-saving drugs, cancer experts have warned.
According to the Institute of Cancer Research (ICR) in London, currently, EU rules allow drug companies to gain exemptions from carrying out trials involving patients under 18 years of age, even if there is evidence that the drugs could work on children.
Drug companies often seek these exemptions because of the expense involved in testing drugs on children. As a result, there are major delays when it comes to new cancer drugs being made available to children, while some drugs are simply never licensed for children with the disease.
However, the ICR has insisted that a change in the current rules could make more drugs available to children with cancer. These changes would include making it more difficult for drug companies to avoid testing their products in those under the age of 18.
The ICR is calling on the EU to change its current system in order to ensure that drug companies have to test more of their products on children. It made this call in conjunction with the European Consortium for Innovative Therapies for Children with Cancer (ITCC), which is based in France.
The two groups have studied the impact of the current EU rules and found that of 28 cancer drugs that were approved for marketing authorisation among adults in Europe since 2007, almost all (26) had the potential to also treat childhood cancer. However 14 were exempted from being tested in children because the specific adult condition which the drugs were developed for did not occur in children.
The ICR is calling on the European Commission to refuse to grant waivers to drug companies exempting them from testing certain drugs on children on the basis that the cancer being targeted in adults does not occur in children.
The ICR emhasised that while these waivers are appropriate if an adult drug will not work on a child, they are often granted to drug companies even when the drug displays a mechanism of action that could be relevant to children.
"Many cancer drugs developed for adults could be effective in children if we were able to test them in clinical trials. 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," noted Dr Louis Chesler of the ICR.
Meanwhile, according to ICR chief executive, Prof Alan Ashworth, it is ‘essential' that cancer treatments are tested in children as well as adults, ‘whenever the mechanism of action of the drug suggests they could be effective'.
"Modern cancer treatments are often targeted at genetic features of the tumour that may be common to a number of tumour types, and to adults' and children's cancers.
"That means a drug developed for a cancer in adults could also be effective against a cancer affecting a completely different part of the body in children. The way EU rules are implemented fails to take this into account," he added.