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?

Tuesday, January 6, 2015

Genetically Modified Organisms in Food and Pharmaceuticals

The entities involved in gene research state that their resultant products are safe but that is a supposition not a fact.

With scant due diligence, a National Academy of Sciences task force determined in 1987 that gene splicing posed no "unique risk." In the professionals' viewpoint there was no evidence of "hazards peculiar" to the technology. This optimistic assessment did not hold—gene manipulation carries serious risks.

The Animal and Plant Health Inspection Service (APHIS), a unit of the USDA, is responsible for ensuring that experimental, genetically-altered, organisms do not escape their test sites and that they are destroyed post examination.

According to the Inspector General's '05 audit, APHIS's oversight over the past several decades has been perfunctory . Prior to 2006 the government had approved over 10,000 applications for more than 49,000 field sites of GM plants. The OIG found that:
weaknesses in APHIS’ regulations and internal management controls increase the risk that regulated GM organisms will inadvertently enter the environment before the agency considers them sufficiently harmless to merit unregulated status.
The agency considers certain GM crops to pose a high risk, such as plants engineered to produce pharmaceutical and industrial compounds, or plants engineered with human genes.
The debate is complex and presently there is no consensus as to the safety of GMO science but it should be considered that the government and their corporate overlords were silent while conducting GMO trials during the 70s. Gene research went into overdrive in 1976 when patents were granted for these creations.

American consumers became the first genetically-altered food test subjects in 1994 when Flavr Savr tomatoes were introduced. Today 88% of corn and 93% of soybean crops have been genetically modified and most of this product is unlabeled and flows into processed foods.

In 1989 consumers learned that their pharmaceuticals were subject to genetic engineering following the L-trypophan tragedy. In this extensively investigated case researchers found that the L-trypophan product manufactured by the Showa Denko company in Japan had been genetically modified with B. amyloliquefaciens Strain V, which likely caused the death of 37 Americans and permanent disability for 1,500 others. For further information please read " An Investigation of the Cause of the Eosinophilia–Myalgia Syndrome Associated with Tryptophan Use " by the New England Journal of Medicine.

It is understood that genetically modified organisms will continue to impact food, drugs and soon animals. This month the NYTs reported that some biotech companies hope to escape regulation by using gene guns rather than bacterium to achieve results.

In December 2013 Jim Hagedorn, Scotts chief executive, told analysts:
If you take genetic material from a plant and it’s not considered a pest, and you don’t use a transformation technology that would sort of violate the rules, there’s a bunch of stuff you can do that at least technically is unregulated. The company has created a stunning array of products that are not regulated
We nor they know the consequences of these GMO clinical trials but we do have the right to know that our consumables have been genetically redefined.