medicatio Monitoring in children

There have been numerous challenges to studying drugs in children involving ethical, scientific, and commercial considerations. Medication monitoring in children is a great challenge.

There are extra protections for children enrolled in clinical trials because they cannot give consent and there must be compelling reasons why a trial should be conducted in the pediatric population.

Pediatric trials are in general more difficult to carry out because you must have special facilities, laboratory and radiological services, and staff who know how to work with children and their families.

Also, the market for pediatric products is small compared to the adult market because children are generally healthy and are a smaller part of the population. The high cost and difficulties associated with these trials are not attractive to sponsors who make these products.
The NIH guidelines for pediatric cardiovascular risk reduction report deals with their position on cholesterol, lipids and lipoproteins.

These guidelines are similar to those published in 2008 by the American Academy of Pediatrics which has been promoting
pediatric use of statins for some time to control high cholesterol.

These young individuals cannot nor can they be expected to give informed consent. This must be given by parents who in many cases lack the information required to make intelligent, informed judgements. Children are special since throughout childhood and well into adolescence they are undergoing complex biological development processes which are vulnerable to adverse influences byrnexogenous chemicals including drugs. But children are viewed by the drug industry as a huge market only partially exploited. Until recently, Merck was working hard to get each U.S. state legislature to make school entry impossible, for example into the upper grades, without having a HPV vaccination.
They recently abandoned this after considerable backlash but not before two states and the D.C. took away from parents the right to decide unless they were able to meet the op-out requirements. Another example conce
s depression and ADHD medications. They represent one pediatric marketing triumph, although this may be unravelling. Few prominent psychiatrists have started promoting the view conce
ing over-diagnosis, overtreatment, serious side effects and limited efficacy.
All that is required is more guidelines bearing some stamp of official approval that pediatricians and general practitioners can follow. The NHLBI guidelines just issued seem to be a perfect example. At the beginning of the lengthy NHLBI report, a list of members of the expert panel is presented along with their potential conflicts of interest. Seven of the fourteen members, including the chair of the panel, declared ties, frequently multiple, with drug companies. In the past, this situation has always prompted criticism from critics and raised questions as to the interpretation and completeness of the cited literature and the potential for “spin” in framing the guidelines.

Childhood development is extraordinarily complex and continues until late adolescence. One can argue that during this critical period it is not a good idea to introduce therapy involving chemicals unknown to human biochemistry which potentially will be taken for a number of years without convincing evidence of either benefit or very strong evidence of the absence of long-term adverse
effects. The former requires randomized controlled trials with event endpoints—an impossibility. The demonstration of the absence of adverse effects is equally impossible since a complete analysis of the impact of therapy on childhood development and the demonstration of the absence of adverse effects that become apparent only after a number of years cannot be achieved.

Improving lifestyle choices, proper eating and drinking habits and using natural methods to prevent obesity and lower cholesterol in young children are much better alte
ative than recommending medications with potential side effects in these precious early years.

We help children in our clinics worldwide through Biofeedback and life style modification to control high cholesterol, obesity, ADD & ADHD Naturally.