Several antidiabetic drugs are not FDA-approved in minors under 18y (“children”). Do they not work? They do. To understand the FDA reasons, we have to step back a bit.

When the children-are-not-little-adult mantra became law in 1997, the FDA offered all pharmaceutical companies financial rewards for pediatric studies. There are two types of diabetes. In one, the body stops producing insulin and can no longer control blood sugar, probably due to an autoimmune mechanism. It’s called type 1 diabetes mellitus (T1DM), previously also called juvenile diabetes because it also occurs in minors. In the other diabetes type, people eat too much and don’t exercise enough. Initially, the body produces enough insulin to lower the blood sugar level caused by hamburgers, candy, or whatever. After a while, the body’s cells become insulin resistant. The body produces more and more insulin, but can no longer lower blood sugar sufficiently. It’s called type 2 diabetes mellitus (T2DM). It occurs also in young people who are overweight.

In the “pediatric” T2DM studies that were performed from 1997 on after the “pediatric” law was introduced, all included adolescents were massively overweight. All tested antidiabetic drugs lowered the blood sugar, but not to a statistically significant extent. The decisive issue in all these “pediatric” studies was not the participants’ age, but that they all were massively overweight. The body does not change at the 16th, 17th or 18th birthday.

Several professional groups and institutions benefited from these studies. Involved researchers could publish “pediatric” diabetes studies, could present their groundbraking results at scientific conferences, could network with other pediatric researchers, and advanced their academic career. The involved companies got patent extensions, allowing them to sell their patent-protected drugs longer before cheaper generic drugs could be sold. The healthcare professionals and scientists running the studies had their jobs. The only ones who didn’t benefit were the young patients themselves, and their parents.

Antidiabetic drugs are often cited as an example of medicines that do not work in children. But it’s wrong. The decisive factor is not the birthday, but that young people become overweight. It is one of the many problems of our time. There is food in abundance and people can kill their boredom or frustration with activities at the computer, iphone, or other gadgets while sitting and moving little apart from eyes, fingers and mouth. It’s a very serious problem. But the T2DM studies are a pseudo-solution. On the surface, they appear to contribute to fighting juvenile diabetes, but they don’t. Welcome to our modern world.

Parents asked to permit participation of their loved ones in such a “pediatric” study should refuse. Institutional Review Boards (IRBs)/ ethics committees (ECs) should reject such questionable studies.

Whoever comes across the argument in a discussion that some drugs do not work in children should use this example to argue against it.