Saturday, November 21, 2015

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.

Wednesday, November 11, 2015

The European Union Resolves that Edward Snowden is not a Traitor

Many if not most Americans now consider Edward Snowden a patriot deserving gratitude not punishment for his truth telling. Since June 2013 the U.S. government has condemned Snowden as a traitor, has issued international warrants for his arrest and made it impossible for him to find a safe haven outside Russia.

Because the European Union has determined that Edward Snowden is a whistleblower and defender of international human rights, member states should ignore U.S. warrants and protect Snowden from extradition and rendition. This important decision is making it more difficult for the Justice Department to gain custody of Mr. Snowden.

Tuesday, November 10, 2015

Bureau of Land Management's Performance Rating: Abysmal

The horse and burro herds living on public land in western states double their population every four years—the Bureau of Land Management who has been responsible for their care since 1971 has done little or nothing to curb the birth rate. The Bureau's performance rating: Abysmal.

It is troubling that the federal agency has never created a viable program to stem the birth rate of these animals. Allowing the horses and burros to breed indiscriminately has caused a nightmarish problem for the excess animals and an increasing financial burden for taxpayers. Presently the Bureau has about 50,000 horses and 10,000 burros living in captivity . The Bureau is seriously considering a massive roundup of the horses living in Wyoming which will strain holding facilities. Each horse kept in captivity costs taxpayers $46,000. The annual budget to feed and shelter the animals is $43 million.

Every year BLM officials determine the number of animals that need to be removed or destroyed to maintain the ecological status quo. Getting the animals off the range and into holding facilities is a costly operation and one that injures or kills scores of animals in the process. The government hires contactors to chase the animals via helicopter from their home turf into holding pens from where they then are crowded into trucks for their final destination. Many young and old animals do not survive the marathon stampede and punishing transport.

Some argue that aircraft herding is necessary but that opinion is faulty because there are numerous examples of animals being moved without mechanical intervention. Take for instance the herds of bison living in Utah on Antelope Island, they are rounded up every year by horseback riders. These animals, who can run at 40 mph, are driven for miles into short term enclosures, vaccinated and then released. Some of the herd is auctioned.

Even though the Bureau has been criticized by the news media, specifically NBC , the National Academy of Sciences , the ASPCA and other groups for their lackadaisical birth control policies the government animals continue to breed putting the horses and burros at risk of mistreatment and unnatural death. Case in point, the 1,700 horses adopted by Tom Davis that were slaughtered .

Those interested in recent BLM history should read the Interior Department Attorney General's report on Tom Davis, a Bureau of Land Management horse buyer. Bureau work is overseen by the Interior Department.

Over a four year period '08-'12, Mr. Davis purchased approximately 1,700 horses at a cost of $17,940. During the investigation Mr. Davis admitted that most of BLM horses were shipped to Mexican kill sites and that he made several thousand dollars off each truckload. Until 2012, the Bureau was paying to have horses shipped to buyers. The Bureau for instance paid $140,000 to ship the horses to Mr. Davis. Remarkably, Mr. Davis was not prosecuted, nor were any involved BLM employees fired.

There was a financial relationship between Tom Davis and former Labor Secretary Ken Salazar. It is unknown whether Mr. Davis received preferential treatment in his dealings with the Bureau but circumstantial evidence suggests that he was a favored buyer of horses. It should be noted that no other buyer came close to Mr. Davis's 1,700 horse purchase order.

There is no facet of the BLM program that is satisfactory for the animals or for the taxpayers. Birth control is not routinely administered to the gathered meres according to BLM reports. The holding facilities where the horses and burros live bear no resemblance to the animals' natural environment. Those adopting BLM horses and burros must provide a three-sided shelter for the animals whereas those confined in government-built temporary or long term holding sites are not afforded such protections.

It is obvious from all accounts that the Bureau of Land Management is a federal agency in desperate need of new management. The current Director, Neil Kornze appointed in 2014, has done nothing to improve the way business is conducted— the population of horses and burros continues to expand as does the BLM budget.