More studies needed for pediatric doses

All the debate over the safety of kids' drugs lately--from over-the-counter cold meds [1] to Tamiflu [2] and Advair [3] to antidepressants--stems from a single cause, according to a Washington Post think piece. Most drugs given to kids were never tested on kids.

For years, conducting clinical trials on kids was considered unethical. Drug makers and regulators figured kids' doses could simply be scaled down from adult levels. Plus, kid-oriented research was expensive and difficult.

Now that's changing, but not fast enough for some experts. Children aren't a big enough share of the market to prompt a wholesale overhaul, some say. Many drugs that need to be studied in kids are already off patent, so drug companies have no incentive to do it. Of the 50 old drugs considered "high-priority" for pediatric trials, studies are beginning on only 14, and these are in the preliminary phases.

Meanwhile, some recent legislation and special programs are using the carrot-plus-stick approach to pediatric trials funded by drugmakers--and so, as the FDA put it, we're learning how much we don't know. For instance, a fifth of the adult drugs tested in kids simply didn't work. Another third caused unexpected side effects, some potentially deadly. "That's what keeps me up at night," one pediatrics prof said. Indeed.

- read the Washington Post report [4]

Related Articles:
FDA does a triple-take on Tamiflu. Report [2]
FDA reconsiders Glaxo asthma meds. Report [3]
Wyeth pulls cold remedies for kids. Report [5]
FDA panel: No cold meds for under-6 kids. Report [1]