Are Clinical Trials on Children Unethical?
A week or so ago I wanted to write about the bioethics issues surrounding clinical trials on children, but was sidetracked by other topics. Tonight, however, I am reminded of the subject by a radio announcer who read somewhere about a trial involving the application of growth hormones to short children. The announcer was quite appalled, as was I, based on the information he gave. So I checked it out, and found a call for subjects to participate in a clinical trial at Harvard and the Children's Hospital in Boston.
Potential subjects are required to have primary IGF-1 deficiency, along with a number of other criteria. IGF-1, or insulin growth factor 1, is a growth hormone that plays a very important role during the development of children. In addition to short stature, symptoms of insufficient IGF-1 hormone production can include delayed development, and reduced bone density and muscle strength, compared to the "norm" for children of the same age. Obviously children suffering from this deficiency have more to be concerned about than simply their height and appearance.
Now that I have more information, a study to investigate supplements to compensate for a lack of natural hormone production doesn't sound like such a bad idea afterall. Of course there are still be many complicated issues to address in terms of testing drugs on children. However, in some cases, such as this one, the tests would not be applicable to adults and could make an enormous difference in a person's quality of life; So, for the time being, there might not be any other option.
Source: American Associate for Clinical Chemistry. 2007. Lab Tests Online website: IGF-1: At a Glance.
Comments
I would argue that NOT doing clinical trials on children is unethical. To categorically exclude an entire segment of the population is not only wrong but dangerous. There are currently a number of drugs out there being prescribed to children that have never undergone the necessary testing to ensure they are safe for children, especially in the long term. It is imperative to have more testing for pediatric drugs and therapies to ensure that we are provided the best treatment.
I personally have a daughter with IGF-1 deficiency. She is being treated for it with medication. She is not in a trial study as her deficiency falls under the severe category and is therefore already FDA approved for her condition. I absolutely thing that trial studies on children are essential. Had it not been for the trial studies of this medication my daughter would have no hope of living a normal life. People need to stop being so judgemental and really get educated on the facts that are relevant to each situation because each situation is different!