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Because [children] make up only 1% of US patients with cancer, [they] are a low priority for pharmaceutical companies that want to launch an effective drug quickly. The hassle of a paediatric clinical trial may not seem worth it until after the drug has proved to be safe and effective in adults.
[...] To access therapies early, parents of these children can turn to compassionate-use programmes, in which companies give experimental drugs to people who are in desperate need. In the United States, firms that agree to provide medicines in this way will ask the Food and Drug Authority for emergency permission, which is almost always granted.
This system, although helpful for some, is rife with complications. Patients and their families report difficulties in applying for such programmes, and say that they rarely receive responses. Companies that withhold a drug — because it is in short supply or not right for a patient — can find themselves on the receiving end of critical social-media campaigns highlighting individual patients. And firms worry that if a person dies or is harmed while taking a drug, it could hurt the drug's chances of being approved.
[...] Designing a clinical trial is never simple, but adding children to the picture complicates the process immensely. Children are not just 'small adults' — they metabolize drugs in very different ways. It is difficult to predict from adult or animal studies whether a chemotherapy drug will be more or less toxic in a child, and at what dose. The process of obtaining informed consent for children participating in a trial can also be more complicated. And companies fear that the death of a child — even if unrelated to the treatment — could bring bad publicity for a new drug.
Recent years have seen attempts to make more drugs available to treat children. In the United States, a 2003 law known as the Pediatric Research Equity Act (PREA) requires that companies develop a plan for how they will test experimental drugs in children, although many trials are exempted.
[...] Legislation is now attempting to close those loopholes. The Research to Accelerate Cures and Equity (RACE) for Children Act, introduced to the US Congress on 14 July, would require companies to apply the PREA to any therapy with a molecular target that is relevant to both an adult and a childhood disease. It would also end the exemption for orphan diseases.
Source: Nature.com
(Score: 2) by Gravis on Thursday August 04 2016, @07:03AM
spending time trying to cure kids of cancer is a highly emotional decision because the facts is that you spending time trying to save 1% of patients when 99% of patients are still dying of cancer. what should be done is work to saving the 99% and then adapt therapies to save the 1%. frankly, i think our current approach to cancer is embarrassingly rudimentary, so adapting it for use with children should be the least of our worries.
(Score: 5, Interesting) by Rivenaleem on Thursday August 04 2016, @10:27AM
When someone dies in a trial, it's a terrible tragedy. Now add to that the emotional multiplier when that's a child. Pharma companies really, really, want to avoid the headline "Child dead in experimental drug trial"
Where I work, we've been asked by the FDA to make one of our drugs in a child-sized dose. This has a lot of technical limitations, as you can't exceed a high-fill limit (to prevent over-dosing) on regular adult doses, and for a child-sized dose the margin for error is even smaller. As hard as it is to fill a vial with 2-3 ml of liquid accurately, when asked to fill 1.25ml it gets REALLY hard to do that safely.
(Score: 0) by Anonymous Coward on Friday August 05 2016, @06:57PM
Go ask biologists or wildlife scientists about how valuable to a species a breeding pair is, compared to a pair of infants of that species.
Emotions due to evolutionary instincts will cause most people to value the children more, but the younger the child the less valuable the child is. If a productive adult is lost due to cancer it is a greater loss to society than if a toddler dies of cancer. So much already has been invested into the adult, and the adult is "paying dividends". Whereas a toddler would still be a net cost for 20 or more years.