There have been a couple items in the news about the FDA's Pediatric Advisory Committee's recommendations that I've found interesting.
One was for the use of anti-depressants for children, in which the advisory panel strongly recommended a "black box" warning on all anti-depressants. The Panel stated that no pharmaceutical company that has an anti-depressant on the market had provided conclusive evidence that its medication is not harmful to children. Only Prozac is actually approved for pediatric care, but many physicians still prescribe other anti-depressants "off-label." The "black box" label will include a very strongly worded warning for all doctors that side effects of the anti-depressant may include increased suicidal thoughts and suicide. The pharmaceutical companies are, of course, concerned that this may lead to fewer prescriptions of the drugs. The American Psychiatric Association has expressed its concern that the warning may keep some doctors from prescribing a drug for a child that could be helpful because of the increased liability risk (one can only imagine the opening statement of the attorney of parents of a depressed child who killed himself after being prescribed the drug), or that it might keep some parents from seeking help for their depressed children.
In other news, though, the FDA advisory panel also recommended the use of a stimulant (dextroamphetamine)in a clinical trial for ADHD in children. The ethics involved with this study are indicative of many of the dilemmas researchers now face in pediatric trials.
One dilemma arises because, although half of the children in the study have ADHD (and thus may benefit from the stimulant), the other half are basically "healthy" and do not have ADHD. The amount of dextroamphetamine that will be given to the children will supposedly have the same effect as one or two strong cups of coffee. There is, of course, always a concern about medicating healthy children.
Another interesting dilemma is that, even though the study sample will be children from ages 9-12, the researchers will be giving all of the girls pregnancy tests. What should they do if one of the girls turns out to be pregnant? Do they tell the parents? They'd have to suspend the girl from participating in the study, and the parents would likely want to know why, after all. However, it's not mandatory that researchers inform parents of their child's pregnancy (though they will typically tell the subject).
The study is also generally coming under fire from those who worry that the test will send the wrong message to children and lead them to drug use/addiction or simply result in a horribly negative reaction.
It's now up to Tommy Thompson to give the final approval for the protocol and the study.
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