Subject:   Regarding Death at St. Louis Children's Hospital
Date:   2002-05-28

CIRCARE has concerns regarding a recent death (May 3) of an 18 month old child, Daniella Rogers, at St. Louis Children's Hospital in human subject research.

1. The appropriateness of using 18 month year old children in a research protocol, rather than engaging in standard treatment. In this case, the subject was in the group given the standard treatment, but another group was given a novel treatment.
2. The risks of the research were not properly identified – most importantly a side effect of the treatment – veno-occlusive disease, which was reported at least in two cases prior to Daniella's death, in which one resulted in a fatality and one a serious adverse event.
3. According to the father, the child was not properly monitored during the research protocol, so that symptoms a couple days previous, early warning signs of veno-occlusive disease, were missed.
4. The fact that alternative treatments were not identified.

Currently the Office For Human Research Protections is looking into this case, and the parents of Daniella hope that reform can be initiated so that future deaths and the tragedy they have endured will not be repeated.

Michael A. Susko MS, CIRCARE President
(410) 499-4895

Adil Shamoo Ph.D., CIRCARE Co-Founder
(410) 706-3327

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Last Updated: 2006-03-04

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