National Lottery needed for Clinical Trial Participants

Without public discourse or media involvement foster children were placed in experimental research studies twenty six years ago. The practice began at the urging of HHS Secretary Bowen who told state and local welfare agencies in 1989 that they 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 no information on how many of these state-protected individuals have participated in clinical trials. Across the country, HHS has had access to approximately 400,000 foster children annually.

When asked how many state wards were engaged in federally sponsored research Dr. Young,
Principal Deputy Assistant Secretary for Planning and Evaluation U.S. Department of Health and Human Services, 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 unlikely that Dr. Young did not have that information he was reporting on the appropriateness of foster children in clinical trials.

To avoid scrutiny the government is mute on the question of how many foster children enter research studies but much can be learned from the government's clinical trial website. It is a certainty that parents will not place their healthy children in experimental studies so where is the government getting its test subjects? The answer: from state welfare rolls.

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

  • 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 is no need for government subterfuge. It is agreed that there is insufficient parent participation in clinical trials so foster children have been used to make up the shortfall. It is not fair that foster children like prisoners of the past bear the burden and risks of experimental studies. All Americans and their children should have to accept the promise and dangers of research by registering to be test subjects. Once on the registry, names would be drawn and those chosen would be placed in appropriate clinical trials.