Tuesday, May 24, 2005
As was noted in this space on May 4, the Associated Press has reported that government-funded researchers have tested AIDS drugs on hundreds of foster children over the past two decades without providing a guardian. The foster children received medical care from world-class researchers, which slowed their death rate and extended their lives, but it also exposed them to significant risks. Even though the government was supposed to appoint independent advocates as of 1983, most research institutions promised but did not provide advocates. Some foster children died during the studies, but no agency can find any record that any death was directly caused by experimental treatments.
In response to the AP story, on May 10 the Alliance for Human Research Protection filed a complaint with the FDA and DHHS' Office of Human Research Protection about AIDS drug experiments on foster children in New York City.
In an op-ed piece in the Toledo Blade, Dr. Mark Kline, professor of pediatrics at Baylor College of Medicine and director of the Baylor International Pediatric AIDS Initiative, responded to an editorial in the Blade that criticized researchers who enrolled foster children with HIV in studies of anti-AIDS drugs without appointing an outside advocate for these children. He wrote that foster children were not singled out but included with other children in the same research. He insisted that the decision to use foster children for research was in part due to the deadliness of AIDS for children during that time since available treatments offered only partial, short-lived benefits. Many of the potent drugs approved for adults in the mid-1990s were not approved for children because no pediatric studies had been done. He stated that researchers did not provide advocates because the treatments could potentially be beneficial and foster children were being put at no more risk than other children in the same situation.
A DHHS official recently stated that "current regulations are adequate to ensure that foster children enlisted in federal medical experiments are protected" (Washington Post).
Thanks to research assistant Lindley Bain for her help with this post. [tm]