Humans and higher animals have a childhood, bacteria don’t. And only humans have a childhood formally defined by conventions and the law. Animals live by the laws of the jungle, as pets, workhorses, or other uses. Bacteria and humans interact sometimes for mutual benefit, like billions of bacteria in our gut, sometimes to our detriment when bacteria multiply rapidly in wounds, organs, or the entire body. Without intervention, this kills. Penicillin, produced by fungi to keep bacteria at bay, was the first widely produced antibiotic. Today there are many more.
When bacteria attack and kill, they don’t ask for an ID. But for new antibiotics, the regulatory authorities demand separate pediatric studies. Why? There are rules. Medically, these rules and the studies they demand make limited sence, but financially and politically, they do.
The antibiotic moxifloxacin is FDA-approved in over 18s (“adults”) for various simple and complicated infections. For approval in minors, the developer would have to submit ‘pediatric’ data in under 18s. Can a 15y-old die of bacterial infection? Yes. Would moxifloxacin help? Yes.
The mentioned rules are based on the children-are-not-small-adults mantra that claims that in minors everything is fundamentally different. True for small babies, but not for school age children or adolescents. The children-are-not-small-adults mantra emerged in the US and was amplified by the European Union (EU). The EU makes commitment to “pediatric” studies a condition for adult drug approval, disregarding that adolescents often already have an adult body (mostly, the mind lags behind J). Drug developers must negotiate a “pediatric investigation plan” (PIP) with the European Medicines Agency (EMA). The moxifloxacin PIP demands ‘pediatric’ studies for complicated intra-abdominal infections in patients aged 3 months to 17y. You don’t believe? Google EMEA-000492-PIP01-08-M01. Some “pediatric” moxifloxacin studies have already been completed.
Bureaucrats love simple tasks they can pursue without reflecting further. “Pediatric” studies have become a condition for drug approval. From such studies profit those that work in the authorities, pediatric researchers that publish them, and health professionals & scientists in clinical research and industry that run them. They all have a job. At the end, all this is paid by those who buy amoxifloxacin, other antibiotics, or other drugs.
What minors really need is the right dose of antibiotics, and excluding toxicities in very young babies.
Most moxifloxacin PIP studies have not yet started. Moxifloxacin is just an example. There are many other antibiotics and other drugs against viral, fungal, and parasitic infections. “Pediatric drug develoment” emerged half a century ago out of concerns of toxicities in newborns that were treated with antibiotics. The concept emerged that all minors are “therapeutic orphans”. It became a machinery where drug developers are forced to commit to pointless studies. Otherwise, their drug is not approved. This machinery keeps many people busy. But there is no medical sense.
Parents should refuse their children’s participation. Institutional review boards (IRBs)/ethics committees (ECs) should not allow such studies to start and should suspend ongoing comparable studies. It’s time for the scientific community, patient advocacy, and the general public to address this issue.