Doctors revolt against restrictive cancer research bill

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Pediatricians, academic hospitals and parents are resisting a law proposal about medical research on children. According to them, the proposal makes it nearly impossible to test new medicine on children with cancer and other serious illnesses while doctors, parents and children do want this. "This means that we are restricting seriously ill children in the Netherlands from new, promising medicine because they are not allowed to be tested here", says pediatrician-oncologist Michiel Zwaan from the Erasmus MC, speaking for the Dutch Association for Pediatrists (Nederlandse Vereniging voor Kinderartsen). Public Health minister Edith Schippers is strictly for the new law, because she believes that children are vulnerable and must be protected from the risks of research.

Critics point out that countries such as England, Germany and France are much more open to medical research. "The Netherlands is taking a unique position in Europe" Zwaan says. "These medicines are unavailable to us for many years because of this. Only when they are registered ten years later, we can also give them." Zwaan says that the Netherlands is going so far to protect children that in the end, it will be hoist by its own petard. Parents, pediatricians and academic hospitals wrote a strong letter to the House of Parliament with the request not to accept the law in its current form. The letter is signed by fifteen professors, under these all the department heads of pediatrics of the academic hospitals. Also nine patient organizations signed. "If the importance of the child really stands at the core", they write, "how is it possible that we in the Netherlands have created a system that does the opposite of what it is supposed to?" "Parents and children now don't have the chance to decide for themselves if they will participate in research for new treatments", says co-signatory Marianne Naafs, director of the Parents, Children and Cancer Association (Vereniging van Ouders, Kinderen en Kanker). "While children with serious illnesses can often already give this a great deal of thought. These children are forced to grow up quickly." The protest is striking because it looked as though Schippers would actually broaden the law. A commission which set itself up - and in which parents were also members - pleaded for this. Still, Schippers set this advice aside and raised the risk ceiling only marginally. As of now, medicine can only be tested on children if the risks "are more than minimal in small cases." According to critics, this offers little change to the current laws. Research with bone marrow punctures and muscle biopsies will still not be allowed, Zwaan predicts. "For a healthy child, this would be very tiring, but here it involves extremely ill children with their backs against the wall. For a child with cancer who has already undergone bone marrow punctures twenty times, it is an acceptable treatment. These children know what they're agreeing to." Experts also warn that the strong rules actually increase the risks for children. Doctors now, due to lack of research data, have to give children 40 to 80 percent of the medicine unregistered and 'off-label'. This means that the dosage has not been officially tested. "Of course we have to be truthful", Zwaan says. "Research doesn't always help the child itself, but other children who become sick after that. Still I see children from 10 years old who say: if I don't do it for myself, then I do it for the others. We now have to wait until medicine has been tested by children in other countries. I wonder how ethically responsible that actually is." Schippers stands behind her decision, however. "The balance between the protection of children and vulnerable people on one hand and the development of new therapy for very sick children and vulnerable people on the other has been carefully looked at and found in this law proposal", she announces.

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