Monday, August 18, 2008

Children are people, too

PLoS Medicine has an article today entitled "Children Are Not Just Small Adults: The Urgent Need for High-Quality Trial Evidence in Children". According to several investigations, >50% of medications used in pediatrics have not been specifically tested to verify their safety and efficacy in children.

If children are so important to us as a society, then why don't we value their health?

PLoS Medicine also has an original paper in this edition that examines the differences in anti-epileptic drugs in children and adults. This study is meta-analysis, therefore it combines many previous studies to examine subtle trends that can be revealed by adding together the patients from other studies. They show that kids are more likely to experience the placebo effect than adults. Although the specifics of what they showed is not incredibly important, the study is particularly interesting because it is an example that kids don't respond to medication in the same way as adults, i.e. it is difficult to directly apply adult studies to children.


frau sally benz said...

This came up in a women's health class I took once. The biggest problem with medication for children and pregnant women is that testing on these groups is seen generally as unethical. They worry that the risks (dead children, unborn fetuses) don't outweigh the benefits (healthier children, healthy mothers).

Of course, this ends up being a problem in the long-run, as you can imagine. Children end up with medication that isn't always helpful, and pregnant women often can't keep taking medication for conditions they already have. They need to consider what kind of balance is necessary in cases like these.

Habladora said...

Scary news, this. Sally, you bring up a great point, though - how do we safely and ethically test drugs for kids?

daedalus2u said...

The placebo effect is something that relates to my research, and which I have blogged about. I see it as a completely normal regulation of physiology, the allocation of resources between things like healing which can be put off, and things like running from a bear which cannot be. When you are under stress, your body puts off using resources for things like healing, because those resources might be needed immediately for dealing with what ever is causing the stress.

I see the placebo effect as the normal neurogenic switching of physiology from the “fight or flight” state to the “rest and relaxation” state where healing can occur. It isn’t a surprise that children are more susceptible to it than are adults. Children are still learning what is safe and what is dangerous, when to rev up physiology to “run from a bear”, and when to relax after mom kisses it and makes it better.

The controlling regulation for human experiments is the Declaration of Helsinki.

The controlling ethical principal is that people in experimental trials must receive some benefit from the trial. If there is a potential benefit (if the subject has a disease without a known effective treatment), then being in a trial where an untested medical intervention with some a priori likelihood of being successful is being tested is a benefit, even if it is compared against placebo (which has no benefit).

If there is no potential benefit, subjects can’t be experimented on unless the potential for harm is very small (and is compensated for by payment). If there is only potential for harm, as in birth defects, an experiment cannot ethically be done. Paying a subject a large amount to compensate for a high risk is exploitation.

People who can’t give informed consent, such as children, can’t be experimented on ethically unless the potential for harm is extremely small.

One of the biggest issues for doing experiments on children and pregnant women is the issue of liability. There is a background level of birth defects. If a particular pregnant woman is exposed to a drug and has a child with a birth defect, the liability to who ever is doing an “experiment” is gigantic, even if the birth defect had nothing to do with what ever the experiment was about.

This is one of the difficulties that I am having with my nitric oxide research. Because I am not a medical professional, I can’t do “clinical trials” (also because I don’t have a clinic). I am quite sure that the “risk” is zero or actually negative (that is everyone will be healthier after using my bacteria), but “proving” that without data is not possible, and without “proving” it, no one will let me get data.

One of the major issues of pregnancy is preeclampsia. There is plenty of research that suggest that is due to low NO. I am quite sure that I have the only physiological method for raising NO (that will actually work), the method that our bodies evolved to use. The other issues of pregnancy and childbirth, hypertension, gestational diabetes, postpartum depression, postpartum psychosis, are also (I think) caused by low NO.

Anonymous said...

You conduct retrospective studies on children and pregnant women, not the superior prospective. Also, you can do studies using drugs that are already being used off label. I would be very reticent to put a kid or pregnant woman on anything experimental. The main exception I can think of would be an experimental drug in a life-saving situation, such as refractory cancer.