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Clinical trials and kids a tough call

Submitted by on Tuesday, 18 August 2009 No Comment

No how, no way, I thought when I saw the news that the National Institutes of Health was about to begin clinical trials of the swine flu vaccine in children.

Oh, I understand that it’s necessary testing. I also get that there are numerous steps before the tests begin on children, including three trials of candidate H1N1 vaccines in adults.

And I wouldn’t hesitate to sign myself up for a clinical trial should I ever be in a situation to do so.

When it comes to making that decision for the guys, though, I can’t do it. Not even on something as relatively benign as a flu shot. I am not going to make a choice that carries even a remote chance that they’ll look me sadly in the eyes one day and ask, “Mom, why did you do it?”

I feel awful about that, because I know clinical trials are important, particularly on medications. Part of the big hoo-ha about cold medications is that they’ve never been tested on children – adult results instead have been extrapolated based on the difference in body size.

Experts know that you can’t do that – children are not just little adults. But they’re also hesitant to test on children.

“Testing in children is intensively debated,” Dr. Michael  Spigarelli, an assistant professor of pediatrics at Cincinnati Children’s hospital, has told HealthDay . “It is felt by the (Food and Drug Administration) and most regulatory authorities that it is unethical to test in children, which means that pediatricians and family medicine doctors are left prescribing off-label, because it’s equally unethical to let a kid suffer.”

I’m not the only parent with qualms.

According to a 2003 article at Applied Clinical Trials Online, many parents hesitate when they see no immediate benefit from the research. They’re much more likely to participate, though, if current remedies don’t work or if the disease is lethal.

That explains my apparent hypocrisy. I would sign Big Guy up for studies into a cure for peanut allergies if we lived near any of the five research centers.

Nor would I have a problem with non-invasive research, such as a study on at a Canadian hospital examining whether children are calmer if they have their parents to comfort them as a broken bone is set.

But for a flu shot?

No how, no way.

I understand that someone has to do it. I’m not proud to say that it won’t be me.

Copyright 2009 Debra Legg. All rights reserved.

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