Most fathers do not know that Almost 80% of the drugs given to their children have not been really tested with children.
In other words, babies and children around the world are taking drugs daily that have not been tested with children, with the risk involved.
The procedure that is currently carried out is to test these medications with adults and then adjust the doses according to the weight of the children.
As this way of proceeding carries several risks, since the body of an adult is not the same, with its fully mature immune system and its filtering systems (liver and kidneys) at full capacity, than that of a baby or a child, in constant maturation, The EU wants pediatric medicines to be tested in children.
The headline is really scary, since any mother and father will be thinking right now that "okay, but not with my son." Perhaps knowing the procedures used, the situation is understood a little more.
Minimizing the risks
Doing studies with children has nothing to do with adults, both because of the physical risks they entail and because of the ethical aspects involved in these procedures.
For this reason, in studies with children the so-called phase I and II are avoided, which are done with adults, which are the most dangerous because they offer information about the safety of a medication and dose adjustments.
By skipping these two phases, children enter the study for phase III, which is the phase in which the efficacy of a new drug is compared with an existing one.
Which children are part of the studies
The children participating in these studies are sick children, since with them parents are more likely to agree to be part of a study. If the disease is serious or incurable, parents usually access more easily, since there is always the illusion (or hope) of finding a new drug that helps the child in some way.
According to the pediatricians who are part of these studies, It is usually more dangerous to give children a syrup that has not been tested with children, than one that has been made for pediatric purposes and more if done under the supervision of the hospital.
The GRIP project
The European Union It has created the GRIP project, which will serve to put all researchers in contact and create a network that serves to establish the basis of the investigations, to supervise the studies that are being carried out and to be able to work under an appropriate legal and ethical framework ( since the subject is very delicate).
