Non-Beneficial Research: Would You Sign Up Your Kids?

Here's the dilemma. Very little research is done on children to examine their responses to adult-tested medications. So when we pediatricians then need to prescribe a medication, the effectiveness is often unclear, the risks are often unknown, and the dose is often an educated guess.

I know - not exactly what you as a parent want to hear about the 'science' of prescribing 'off-label' (meaning untested, which most are) medications for your kids. I agree. I'm not comfortable or happy about this state of affairs. Still, like all pediatricians, despite the lack of scientific evidence, I soldier on and continue to prescribe those medications to my little patients. Should I do otherwise?

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This question arises when we read disturbing stories about medications that, unexpectedly, are not helpful or are even harmful in kids (e.g., cough and cold medicines - see my recent post on this: ROUND 2: The FDA and OTC Cold Medications for Infants). When that happens, everyone clucks: How could pediatricians have used these medications when there was no evidence of benefits for kids and when the risks were unknown? It's shameful!

Certainly, we all would like to see more research done on children. Or would we, really?

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Let me make this issue personal: Would you allow your child to be enrolled in a research study that would be of no benefit to him/her and might have some risks, even if the information derived from the study might some day benefit other peoples' kids?

An interesting new study* asked 81 parents just that question, followed by differential risks: "a chance of getting a headache for a few hours" or "a small chance of a broken bone" or "a one in a million chance of dying" or "the same risk as riding in a car". How would you respond?

Results:

• 79% of parents said they would let their child participate if there were only the risk of getting a headache.


• 24% would allow it if there was a small risk of a broken bone.


• 18% of parents would OK the research if there were a one in a million chance of death.


• 93% of parents said OK if the risks were the same as riding in a car. (By the way, the risk of being killed while riding in a car is about one in a million!).

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Dr. P Comments
So there you have it. We indignantly condemn the lack of studies on medications for kids but - quite understandably and justifiably - most of us wouldn't allow our kids to be involved in such research.

So the next time a bad side effect of a medication generates lots of heat and everyone tut tuts the fact that it was used in children without scientific evidence, ask yourself: what was the alternative? Should we never use any medications in children for which there is little or no scientific validation? If that were to happen we'd almost never use medications in kids at all. Welcome back to the 19th century.

If you are unwilling to enroll your children in research, then maybe you too will have to embrace our imperfect solution: to keep giving these adult-tested meds to kids, to hope they help and not hurt, and to be ever vigilant for evidence of no benefit and possible harm.

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*Study cited:
"Children's and their parents views on facing research risks for the benefits of others."
Wendler D and Jenkins T. Archives of Pediatric and Adolescent Medicine. January 2008

Related Topics:

• WebMD Video: Treating Baby's Cold
• Concerns for Women, Children in Clinical Trials

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