Friday, January 30, 2015

Foster Children in Harm's Way

In 2005 the Associated Press reported that foster children had been denied required protections when state agencies enrolled their wards in federally-sponsored AIDS clinical trials in the 80s and 90s.

This explosive news prompted a congressional hearing on whether foster children should be engaged in research projects and if they are selected, are their interests being meaningfully protected?

Post investigation, the government conceded that foster children's rights had been violated but that the group would remain in experimental enterprises.

Federal policy—the taking of foster children for experimental purposes—was detailed by Dr. Donald Young, Principal Deputy Assistant Secretary for Planning and Evaluation U.S. Department of Health and Human Services in 2005 in his testimony before the Subcommittee on Human Resources.

Dr. Young explained that the use of foster children in clinical research was necessary for scientific purposes. The inclusion of foster children in research was initiated by HHS Secretary Bowen in 1989. Secretary Bowen said:
State and local child welfare agencies should create systems to manage the participation of children in foster care in special medical treatment and experimental trials.
(HHS/ASPE, 1989, p. 60).

The Department of HHS provides limited data on foster children and none on how many of these state-protected individuals have been placed in clinical trials. When asked how many state wards were engaged in federal research Dr. Young told the subcommittee that:
We know that across the National Institutes of Health (NIH) there are a number of clinical trials ongoing and children participating, but I do not have numbers of children in foster care that might be in that group.
It is implausible that Dr. Young did not have that information— he was testifying on the matter of foster children in clinical trials.

When 7-year old foster child Gabriel Myers committed suicide in 2009 the state of Florida asked the FDA to confirm or deny whether the child had been enrolled in Dr. Sohail Punjwani drug trials. The FDA refused to answer and Florida responded that henceforth no Florida foster child would be used in pharmaceutical research. For additional information on the death of Gabriel Myers please see ABC's " Doctors Put Foster Children at Risk With Mind-Altering Drugs ."

Parents generally do not volunteer their children for research projects that involve risk and provide no benefit. The FDA may not be forthcoming regarding foster children in clinical trials but much can be learned from the information that is available. 

The following are examples of children in vaccine and infant formula research that provide no favorable outcome to the participants. These children were likely selected from state welfare rolls.

  • Clinical trial to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine in male and female test subjects, ages 11-17. There were 2,499 participants.

  • Evaluation of the safety of FluMist in children and adults. There were 63,061 enrollees.

  • The standard care for children with UTIs is a ten day regime of antibiotics. This study shortened the treatment period to five days.

  • Study to determine the efficacy and safety of CAIV-T compared to TIV. This exercise utilized 8,500 children.

  • The Swine flu vaccine safety test involved 1,357 children.

  • Investigational study to determine the safety of MenACWY Conjugate Vaccine when given to healthy children; 2,907 children participated in the study.

  • GlaxoSmithKline study of two doses of live attenuated HRV vaccines in 529 healthy infants.

  • A study to determine the safety of a new measles, mumps, and rubella vaccine. The product was tested on 1,100, twelve to eighteen month old, children.

  • A trial to gauge the safety, tolerability and immunogenicity of MCV4, Tdap vaccine and Bivalent rLP2086 vaccine when administered concomitantly to children ages 10-13. There were 2,677 children in the study.

  • An evaluation of the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in 784 healthy children.

  • A trial to determine if an experimental infant formula provides normal growth. Mead Johnson Nutrition expects to enroll 315 infants.

  • A study to evaluate the gastrointestinal tolerance of six experimental milk protein-based powered infant formulas in 270 newborns.

  • New Starter Formulas and controls were  tested on 297 infants.

  • Hydrolysate Formulas and control products were  fed to 195 infants.

  • Amino Acid Infant Formulas and control products were fed to 225 infants

  • Control and experimental formulas were fed to 424 newborns.

  • Investigational formulas given to 168 infants.

There were 402,378 children under state custody as of September 30, 2013. Foster children die and are harmed as a result of their involuntary participation in the government's experiments.

Where is the outrage?

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