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.

Friday, October 23, 2015

The Bureau of Land Management's Cruelty to Animals



The numbers of horses and burros living on public land doubles every four years. These herds have been under the Bureau of Land Management supervision and protection since 1971. Because the Bureau has failed to control the number of horses and burros being born thousands of animals have and are receiving cruel treatment when they are moved to holding pens.

In 2013 NBC News filmed the Bureau of Land Management contractors causing wild horses and burros pain and extreme distress during roundups (gatherings). Anyone looking at the film footage would question why the Bureau of Land Management and its contractors were not charged with cruelty to animals. At the time of the filming the Bureau was spending 1.5% of its budget on birth control which is why there is no room for the thousands of equids who are removed from public lands every year. Forty six million dollars is expended annually to care for the 50,000 horses in BLM captivity.

Roundups/gatherings are cruel occasions for it means that helicopter pilots are allowed to chase the animals sometimes for miles until they reach barbed wire enclosures. Once inside the animals respond with panic and try to escape by repeatedly hitting the fences with face and feet. Looking at the NBC film footage it is easy to see the gouge wounds. The barbed wire injuries are grievous and avoidable. Surely the Bureau of Land Management executives are aware that electric current fences are far more humane deterrents.

It isn't just roundups that stress the animals. When the horses and burros are moved they are crammed into trucks. To accomplish this task the men repeatedly strike the rump of the animals with electric prods. Sometimes the panic-stricken animals fall and when they do they are unable to regain their footing because of the number of animals being transported. Once down they are then trampled by hoofs of the other animals packed in the truck. Less crowded vehicles would stop these horrific deaths. The BLM has long been criticized for their holding pens because they confine the animals in small enclosures that provide no form of shelter from harsh weather conditions. Responding to public criticism the Bureau has begun adding shelter to their holding facilities. Samples of shelters may be found here. Most of the horses and burros removed from western states spend the rest of their lives in confinement.

Almost all aspects of the BLM program, the roundups, transportation and holding pens evidence an agency unconcerned with the animals' wellbeing.

Congress directed the Bureau of Land Management in 1971 to protect the wild horses and burros from capture, branding, harassment and death. Even though the wild animals are harassed and subjected to painful injuries, sometimes death, the Bureau says the gatherings are “necessary and justified.” It is not known how helicopters came to be used in roundups but this herding technique is in reality nothing more than a cruel sport. Young and old animals do not survive the torturous chase.

Those viewing the NBC documentary and other images on the internet would say that there is no justification for the mistreatment that the BLM horses and burros receive from their handlers.

Nor is there any reason that BLM officials did not commence birth control policies more than two decades ago. If they had adopted birth control practices, the agency would not have an excess animal problem and the horses and burros would not have suffered the cruel consequences of being gathered.

After reviewing the Bureau of Land Management practices the National Academy of Sciences in their 2013 report called the gatherings and long term storage facilities " expensive and unproductive ." The NAS report raised the question of why the Bureau had not initiated full scale population control measures long ago. PZP, a proven contraception vaccine, has controlled the horse population on Assateague Island and has and is being used to limit deer conception all over the U.S.

The person responsible for the animals' wellbeing is Neil Kornze and he was appointed Director in the spring of 2013. Mr. Kornze has served the bureau since 2011 and has been on the job long enough to know that his federal agency has failed its mission to properly care for the animals under its supervision.

It is obvious that a "good ole boy network" is making decisions for the bureau. This group of people, usually men, do not believe in birth control and they are oblivions to animal pain and suffering. These
individuals know that it is commonplace for animals to die or suffer serious injury during the gatherings. Aircraft roundups should be outlawed.

Judging from Mr. Kornze's indifference to the problems under discussion, he should step down. His departure would allow Congress to appoint a Director who would make birth control a priority. When the herd populations are stabilized and the 50,000 horses in captivity die of natural causes, the costs to taxpayers will be reduced significantly.

Saturday, September 26, 2015

Tonto National Forest horses to be "condemned, destroyed or otherwise disposed of"



Federal officials announced recently that the Tonto National Forest horses that will be sold at auction are to be "condemned and destroyed, or otherwise disposed of .” Tonto National Forest horses are classified as strays so they are not covered by the protections of the 1971 Wild Free-Roaming Horses and Burros Act.
 
To minimize growing criticism of the scheduled auction, national forest officials have delayed the sale for four months. Many of the expected purchasers are " kill buyers " who will immediately load their purchases onto long-haul trailers for shipment to Mexico or Canada to be processed into horse meat for foreign consumption. The cost of horse meat in Europe is about $20.00 per pound.

It has long been acknowledged that the businesses engaged in transport are not properly caring for the animals while in transit. Electric shocks are used to force the horses into trucks. Once confined, they forced to stand for long hours (sometimes twenty four) in claustrophobic quarters and are not fed or watered. It is no matter if horses die for they are a cheap commodity. Horses surviving the journey to the kill site suffer greatly. Approximately 150,000 horses are shipped out of the US annually. Long-haul trucks ferried 102,554 horses to slaughter houses in Mexico last year and 39,523 horses to Canadian facilities.

Congress knew that horse slaughter was a contentious issue so in 2007 they effectively shut down US horse processing sites by refusing to pay for inspections. Legislators could have permanently settled the issue by outlawing US slaughter facilities and forbidding horse transport to foreign countries but instead chose a defunding tactic. For a timeline of US Horse Slaughter Legislation please visit here .

It makes no difference whether horses are protected or strays, getting the animals to designated sites is a punishing affair. Imagine the fear that the horses experience as they are harassed by helicopter pilots or motorcycle drivers whose only job is to get them into enclosures. These mechanized roundups cause numerous injuries and death to foals and elderly horses. These casualties are of no concern to the government contractors. There are no penalties for inflicting pain.

Many of the Bureau of Land Management holding pens have no shelter for the animals. The horses are subjected to punishing weather conditions be it blistering heat, frigid cold or high winds. Looking at images of these federally-financed facilities makes one wonder if the agency is committed to the horses' wellbeing. There are approximately 50,000 horses in BLM captivity. The cost of care is 46 million dollars a year.

In spite of the fact that birth control measures have long been available, the BLM has chosen not to institute anti-fertility measures and consequently the wild horse population has grown to unmanageable numbers.

For example, the PZP vaccine available for more than twenty years has been successfully used to control horse populations on Assateague Island, a federal wildlife refuge off the coast of Maryland.
PZP is cost effective, has no side effects and has also been employed to control the US deer population.

Thousands of western horses have been subjected to horrifying conditions and painful deaths because BLM officials have failed to intervene. Only incompetent individuals would allow animals to breed till they put themselves and others in harm's way. Park service personnel say the Tonto National Forest herd of 100 horses has to go because they threaten public safety. The government says that the horses have wrecked camp sites and have been hit and killed by cars.

It is past time for Congress to tell the Bureau of Land Management and its director, Neil Kornze to stop the needless breeding. Prior to his BLM appointment, Mr. Kornze served as the agency's Principal Deputy Director. Mr. Kornze has been on the job long enough to know that the US has a critical horse population problem. For 2015 the BLM plans to gather 4,067 horses, remove 3,322 and provide dart gun fertility control measures for 470.

For a graphic presentation of the injuries sustained by the horses and burros during the gathers please see this video recorded by NBC News. A Bureau of Land Management spokesman told NBC that 1.5% of its budget is devoted to population suppression. Currently 26,715 horses and burros exceed the Appropriate Management Level and will be removed from public lands. Removed generally means death.

The NBC film is so disturbing that it raises the question of whether Neil Kornze and his subordinates are qualified to oversee the Bureau of Land Management. The NBC report is not suitable for grammar school children but it should be required viewing for high school and college students who are studying government.

Wednesday, August 19, 2015

The Bush Iraqi War Lies, an Act of Treason


Treason is the act of betraying one's country. When President George W. Bush, Vice President Dick Cheney, Secretary of State Condoleeza Rice, Secretary of State Colin Powell and Secretary of Defense Donald Rumsfeld lied to Congress, the UN, and the public about their reasons for invading Iraq they committed treason . The lie is not treasonous but the consequences of the lie are if they give aid and comfort to America's enemies.

Intelligence officers certainly warned the president and his advisors that the U.S. occupation of an Arab country would ignite a firestorm throughout the Arab world. Those who hated the U.S., for example bin Laden, now had the perfect terrorist recruitment tool.

The Bush administration's basis for seizing Iraq was Hussein's weapons of mass destruction but investigators found no WMD in the country.

The contrived reasons for taking Iraq destabilized the Middle East, spawned Isis and strengthened Al-Qaeda.

Recently the Obama administration said no to a petition to pardon Edward Snowden. Officials said that Mr. Snowden's decision, to “steal and disclose classified information had severe consequences for the security of our country and the people who work day in and day out to protect it.” Whether these allegations or true or not, Mr. Snowden's actions are minor offences compared to those of Bush, Cheney, Rice, Powell and Rumsfeld.

`

Saturday, July 18, 2015

Enviva's Poisonous Pellet Product



Enviva, a biomass manufacturer, went public in the spring of 2015.

Prior to its IPO,  Enviva touted its wood pellet product as cleaner-than-coal energy but that statement was only a sale's tool.  Presently the company's customers are foreign energy utilities who are receiving government subsidies to buy and burn wood pellets rather than coal. Investors and clients are learning that the burning of wood pellets is not beneficial to the environment. In fact biomass as an energy source is a critical air pollutant, producing 50% more CO2 than coal.

It isn't just make believe environmental statements that should give investors and clients reason for doubt. Enviva's timbering practices were criticized by The Wall Street Journal a few years ago. The newspaper questioned the company's source of wood. Enviva's spokesmen had reported that the bulk of their wood was purchased from sawmills and pine tree plantations. Contrary to Envivaspeak the company's primary source of wood is southern forests. Wood pellet mills, including Enviva's are located in southern states and are growing in number. Stand outside these production facilities and watch the entering trucks bring large hardwood trees to the grinder. Enviva and its competitors are devastating southern woodlands to produce greenhouse toxins for foreign entities. In June The Washington Post raised the same red flags as The Wall Street Journal concerning Enviva's forestry practices and far fetched energy claims.

For the truth of biomass manufacturing please google Enviva images. One of the photos taken by the WSJ shows an eighty-one acre tract along the Roanoke River in North Carolina that was clear cut by Enviva operators. It is not known how many trees it takes to make 1.74 million metric tons a year but that is Enviva's advertised processing capacity. When biomass loggers work a forest site it is razed to bare dirt. There are reasonable concerns regarding Enviva's forest removal techniques. Experts warn that Enviva's denuded landscapes will raise the risks of flooding and erosion events.

One would not expect Enviva's owners to need public money to expand their business but the costs of the Enviva Pellets Northhampton facility was underwritten by various federal, state, and local agencies including the Economic Development Administration , North Carolina Department of Commerce, Golden Leaf Foundation, and the North Carolina Rural Center. Enviva's owners, Riverstone Holdings, LLC , a $20 billion private equity fund, was the beneficiary of these public funds. In addition to those sweeteners Enviva received $ 1.7 million in North Carolina tax rewards.

Carbon dioxide levels reached a never-achieved point in March according to NOAA and exceeded 400 ppm for an entire month. The trees being pelletized by Enviva and other biomass manufacturers were pulling massive amounts of CO2 from the atmosphere. Now these pellets are contributing to the earth's warming.


Thursday, June 25, 2015

About Michael Morell's New Book



Michael Morell, former CIA deputy director, current self promoter would have readers of his new book, "The Great War of Our Time: The CIA's Fight Against Terrorism - From al-Qaida to ISIS," believe that Edward Snowden's release of classified documents in 2013 advantaged terrorist organizations such as ISIS. Mr.Morrell offers no proof that Snowden was instrumental in enhancing terrorists' abilities to avoid detection but uses the allegations as a sales gimmick. If possible Mr. Morell would accuse Snowden of complicity in the September 11 attacks. Mr. Morell's focus on Snowden is nothing more than a distraction from the real issue which is why the CIA had no clue that al-Qaeda had formed a motley crew of Saudi nationals to bomb the twin towers, the Pentagon, and an unknown government building with commercial jets. Although the 911 attacks are the greatest intelligence failure in U.S. history there are no answers as to how this horror came to be. Remarkably the CIA has not had to answer for the 911 breakdown or its erroneous intelligence reports regarding Iraq's nonexistent WMD. The CIA has caused irreparable harm and is responsible for the Middle East maelstrom. It is not Mr. Snowden who endangers the US, it is retired government officials who hope to profit from their unbelievable books.

Monday, June 15, 2015

Carepartners' Angels


CarePartners, an Asheville, North Carolina rehabilitation facility, cared for me for three weeks after I suffered a stroke in early May. The stroke damaged my left arm and leg.

Shortly after entry into the hospital I was enrolled in CarePartners' rehabilitation programs which are designed to restore function to damaged limbs. It was an amazing adventure and because of the efforts of the physical and occupational therapists my leg and arm are responding to treatment. It is a long-term endeavor but I have been offered recovery. I owe CarePartners' therapists a debt of gratitude for they are responsible for my recovery.

Sunday, June 14, 2015

Senators Mccain and Flake Responsible for Sale of Sacred Site

An area known as Oak Flat, Arizona , long revered and protected since '55 as an Apache holy site was recently bartered in a foreign land exchange deal. The copper to be extracted from the Oak Flat mining site will primarily benefit Iran and China. Congress approved the exchange at the behest of Senators John McCain and Jeff Flake. For smooth sailing McCain tacked H.R. 687 onto the National Defense Authorization Act which guaranteed passage. For quid pro quo McCain received campaign funds from the new owner, Resolution Copper Mining, part of the Rio Tinto conglomerate. Flake before gaining entry to the Senate was a lobbyist for Rio Rössing Uranium. Oak Flat is sacred ground for it is where Apaches go to pray. The planned despoliation is like plundering Gethsemane for economic advantage. Members of Congress should be barred from selling sacred places. McCain, Flake and the members of congress who supported the Oak Flat transaction deserve harsh criticism for their participation in the scheme. For further information on this shameful legislation please read " Selling Off the Holy Land ." Congress can repair the injury done to the Apache people by rescinding H. R. 687. [ Southeast Arizona Land Exchange and Conservation Act of 2013].The question is will they?

North Carolina's Bloodlust Sport

Governor McCrory and the state legislature support wildlife killing fields. For effortless deer kills North Carolina allows property owners to lure state animals onto private property and then fence them for slaughter. Private deer farms also supply animals for the state's death sport. Killing captive animals does not fall under the definition of hunting. It is death for pleasure. North Carolina hunters may use AR-style weapons in their sporting endeavors. It could be said that North Carolina is a savage state.

Friday, April 17, 2015

Is There a Facially Legitimate and Bona Fide Reason for Denying the Berashk Visa?



The administration's writ of certiorari complaint in the case of John F. Kerry, Secretary of State, et al., Petitioners, v. Fauzia Din, illustrates the government's unwarranted obsession with secrecy in visa determinations.

The trigger for the certiorari writ was the Ninth Circuit's ruling that American citizens are entitled to know why spousal visas are denied. The case under consideration concerns Fauzia Din, an American citizen and her husband Kanishka Berashk, an Afghan national.

Shortly after her marriage to Mr. Berashk in 2006 Ms Din filed an immigrant visa petition on behalf of her husband. The petition was approved by U.S. Citizenship and Immigration Services [USCIS].

Mr. Berashk then visited the U.S.Embassy in Islamabad to apply for his visa. Generally visa applications are granted or denied in a six-week period. Mr. Berashk was not notified by the U.S. Embassy until June 2009 that his visa request was denied due the belief that he had engaged in terrorist activities. The government notified Mr. Berashk that its decision was final and not subject to appeal. With all avenues closed Ms. Din decided to challenge the consulate's decision by asking for judicial review. The district court hearing Ms. Din's complaint elected to dismiss the case based on the doctrine of consular nonreviewability. This rule prohibits the judiciary from questioning visa decisions.

The next court assessing the Din complaint was the Ninth Circuit. They ruled that an American citizen has the right to know why her husband was denied a visa,  Being that the case involves national security the court suggested an in camera hearing so a judge could evaluate the worth of the government's allegation. This suggestion was rejected by the administration because in its opinion federal judges cannot be trusted with national security matters.

Because the government has refused to provide any documentation regarding Mr. Berashk's persona non grata status the Ninth Circuit said the government's terrorist claim is not valid. In other words without evidence there is no facially legitimate and bona fide reason for denying the Berashk visa.

If the administration wins its writ of certiorari petition pending before the Supreme Court neither Mr. Berashk, his wife nor the public will ever know if there is any merit to the terrorist claim. Several groups have filed amicus briefs on Ms. Din's behalf. Most notably is the one filed by Former Consular Officers. In their brief the group said present day visa evaluations are not based on consular input but rather on often faulty data drawn from suspect sources. In the officers' opinion:
Judicial review is a necessary safety valve for visa denials relying on databases and watchlists that are compiled with variable reliability by multiple agencies, several of which have no authority over visa decisions.
Executive and congressional decisions often violate constitutional boundaries. Judicial review keeps these parties on notice that there is another group reviewing their activities.


Friday, February 27, 2015

Children and Lobotomy Drugs


Lobotomies, surgical interventions for depression, psychosis and homosexuality disorders were performed on 40,000 Americans from 1936 to the early 70s. Generally these surgeries were performed without patients' consent.

The Wall Street Journal 's Lobotomy Files informs that 2,000 WW II veterans received psychosurgery while under Veterans Administration care. Patients surviving the procedure were narcotized for life.

The American Psychiatric Association classified homosexuality a mental aberration until 1973.

Public concern regarding lobotomies and other novel experiments conducted on the mentally infirm caused President Carter to set up a National Commission to examine the issue. Members of the Commission determined that Nuremberg protections were not applicable to this vulnerable group because:
....some research involving the mentally infirm cannot be undertaken with any other group, and since this research may yield significant knowledge about the causes and treatment of mental disabilities, it is necessary to consider the consequences of prohibiting such research. Some argue that prohibiting such research might harm the class of mentally infirm persons as a whole by depriving them of benefits they could have received if the research had proceeded.
Psychosurgery, rarely performed in the U.S today, has been replaced with mind-altering drugs which are another form of lobotomy.

Adults were the first population to receive antipsychotic medication. Now these products are commonly used by pediatricians and psychiatrists to control recalcitrant children. There is limited evidence , other than prescription practices, to validate the use of these medications in children. Diagnosing mental disorders in children is a subjective exercise and there are numerous indications that PhRMA and physicians have abused their licenses. Adults choose their treatment regimens; children have no say in their health care.

A 2013 Consumer Reports investigation found that the use of anti-psychotics in children has nearly tripled in the past decade and that many of these prescriptions were written off label i.e. without testing and FDA approval. Consumer Union calls the practice of prescribing anti-psychotic drugs to children an unregulated experiment. Suspect physician practices include concomitant use of five or more anti-psychotics and application of these drugs in children under the age of three.

Medicaid-insured children including state wards are far more likely to receive anti-psychotics than those in the general population. Foster children are targeted because they are routinely used in government-sponsored clinical trials.

Health Canada reported in 2013 that anti-psychotic medication had killed 17 children and harmed 73 others.

The FDA requires drug manufacturers to place black box warnings on most psychotropic medications, an acknowledgement that these products pose grave risks to patients.

American children have died and suffered injury as a result of their psychotropic drug treatments. The question of whether these medications are worth the risks is unknown because the FDA has not released casualty reports.

Thursday, February 5, 2015

U.S. Meat Animal Research Center's Death Pit


James Keen, a former scientist/veterinarian at the U. S. Meat Animal Research Center notified the New York Times a year ago that the Nebraska site's cows, pigs, and sheep were subjected to painful, unnecessary experiments that caused crippling ailments and death.

The center, operating under Agriculture Department purview, is exempt from the Animal Welfare Act  which means that the center's personnel may conduct any manner of experiments on its test animals without regard to their suffering.

Freedom of Information documents obtained by the Times verified Dr. Keen's complaints regarding animal mistreatment at the U. S. Meat Animal Research Center. Examples of cruelty cited by the newspaper: animals undergoing surgery without anesthesia, pigs and cows placed in steam chambers, newborn lambs left in deadly environments and pigs held in claustrophobic quarters. Animals who do not survive the experiments are disposed of in the facility's death pit.

The Times exposé may affect change for these hapless animals.

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.