New  medicines are tested on adults, but frequently prescribed to children  suffering from the ‘adult’ disorder. How do physicians know the proper  dose for sick children? How do they know if the drug will be effective?  The prevailing wisdom treated children as small adults. Physicians now  believe that this assumption may harm children, resulting in  overmedication, undermedication or adverse effects.

At a presentation at the AAAS annual meeting in Chicago,  I learned that physicians in the U.S. and the European Union are  studying the effects of adult medication on children, but have come up  against the issue of informed consent.

Human  subjects that agree to participate in a clinical study must “be given  the opportunity to choose what shall or shall not happen to them,”  according to the U.S. Department of Health and Human Services. Parents may give consent on behalf of their children.

Studies  of treatments for life-threatening situations, however, may not provide  time for informed consent. A child having a seizure, potentially  life-threatening, requires immediate treatment. The traditional drug is  diazepam; a newer drug of the same class is lorazepam, even though it’s  never been tested in a clinical trial on children.

A  new NIH study is comparing which seizure medication is more effective  in children, using the principle of exception from informed consent  (EFIC).

Under  EFIC, clinicians can treat a child with seizures using either  medication  without first  receiving consent from the parents. After the child is stabilized, the  parents can choose to opt out the child has still received treatment,  but no further data will be recorded as part of the study. Moreover,  parents may stipulate that in future seizure situations, their child  not participate in the study but receive conventional treatment.

The  guidlines for EFIC are strict: close supervision from the institution  where the study is performed, public disclosure, community  consultation, and the physicians must attempt to get informed consent  as soon as possible.

By - Joseph Letzelter