Not long ago relatively little could be done against diseases. Nor did people know their cause. Today we know about bacteria, viruses, & more. Back then people prayed a lot, but whether this helped was a question of faith. Many children died early. Things changed eventually with improved hygiene, clean water, better nutrition, clothing, housing, vaccinations, and drugs. Effective drugs are relatively new in human history. Previously, there were opiates and alcohol for pain relief, sleeping, or relaxation. An infected wound killed, unless a surgeon amputated. Military surgeons were skilled at this.
Drug are developed at the interface of science, medicine and industry. Vaccines have massively reduced child mortality. Without modern drugs, millions who have a normal life today would long have died, including accident survival, diabetes, childhood cancer, heart disease, & more. Previously, you could buy in a pharmacy and self-medicate. Today you need a prescription. Only approved drugs can be prescribed. This puts several layers between individual and treatment: doctors, pharmacists, licensing authorities, reimbursement institutions, & more. Modern drugs can also be dangerous. Thalidomide led to thousands of birth defects. Enter children.
US and European Union (EU) laws demand separate studies in children. Children have the right to tested medication, haven’t they? Sounds good, but there is a catch. We associate with children cute, little, vulnerable humans. But legally, minors up to the age of majority are children. Under the guise of concerns about health and safety of “children,” a coalition of researchers, regulatory agencies, and others enforce futile studies in adolescents that are physically already mature, and grossly exaggerated studies where dose-finding could be done with much less effort.
Many diseases have lost their horror. Effective treatments exist now for many previously fatal or terrible diseases. More effective drugs are being developed. Today, we focus on diseases that were previously ignored: rare diseases (and, of course, currently the ongoing COVID-19 pandemic). For all new drugs, authorities demand studies in minors under 18, supported by “pediatric” researchers. Parents are told that without clinical verification there are risks. But once a drug (or vaccine) is approved in adults, we known its risks in humans. No drug that works in an adult will let a 17-year-old drop dead. The only exception are newborns, and more so premature newborns.
Every century has its own challenges. One of uurs is that high trust in authorities allows “pediatric” research, where researchers publish paper after paper on banalities, such as that insulin works also in humans under 16, and similar groundbreaking discoveries. Fifteen-year-olds are not another species. Nothing happens in the night of a birthday.
The FDA has relented in many areas. Today it accepts that drugs for epilepsy work also in minors. But in most areas the demand for “pediatric” studies continues, resulting in “pediatric” careers in research, government and pharmaceutical industry. The EU demands continue, and as we live in the age of globalization, EU-demanded studies endanger also
American children. It’s time for parents to take a critical look, refuse participation in questionable studies, and call for a change in the pediatric laws. It’s time for pharmaceutical industry to develop a critical position towards official requirements.