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.

Tuesday, December 30, 2014

The FDA and Pharmaceuticals: False Sense of Security

Consumers conduct business in a global marketplace but, unlike most world citizens, Americans outside the state of Maine do not have the right to import pharmaceutical products for medical necessities. Although the government rarely prosecutes those purchasing from foreign suppliers, the policy restricts choice and is a form of intimidation. The government's rationale for banning out-of-country manufactured drugs is safety.

The patient protection claim is absurd for more than 80% of the active ingredients in U.S. drugs have been formulated in foreign, primarily Indian/Chinese, venues. Often these businesses are owned by American pharmaceutical companies who have found significant savings by using foreign labor. Most products, food/clothing etc. imported into the U.S. indicate country of origin. Pharmaceuticals products do not provide this advice.

According to the General Accounting Office, global pharmaceutical production sites are rarely, if ever, checked by U.S. regulators:
FDA’s foreign inspection program continues to be driven by new drug applications and the agency acknowledges that it may never inspect most foreign manufacturers exporting pharmaceutical products to the United States. (GAO 1998 Report: "FDA: Improvements Needed in Foreign Drug Inspection Program" pg. 33)
In 2011 the GOA found the same FDA inspection deficiencies.

The government knew or should have known that these infrequent inspection regimens would be the cause of nightmarish patient outcomes. Two notable examples are the contaminated heparin drug imported by Baxter in 2008 and the other is the 2012 New England Compounding polluted methylprednisolone acetate product.

In both instances deviant manufacturing practices and perfunctory regulations caused death and injury to hundreds of patients. As noted by the General Accounting Office Congress's failure to allocate adequate funding for regular inspections poses needless risks to consumers. To ensure product safety, foreign and domestic facilities should receive annual unannounced visits by the FDA and no pharmaceutical product should enter the US market without said inspection.

As long as pharmaceutical prices were reasonable, most Americans did not question the legitimacy of the federal foreign drug prohibition but the costs of drugs, especially generics has risen inexplicably in the last two years. In some cases over 500% report congressional researchers. For information on savings from foreign distributors please visit

Last year, in violation of federal law, the Maine legislature decided to provide state residents with an option—Mainers can legally purchase pharmaceuticals from Canada, Great Britain, Australia and New Zealand. The Maine Drug Importation Law provides consumers with choice and savings. The state of Maine is being sued by PhRMA and other interested parties who claim unfair business practices among other issues.

In early December Bloomberg News published a timely article on foreign drug imports. It is titled " Drug Batch Tainted? Just Hit Delete and Ship It to the U.S ."

Contrary to the FDA's opinion, it makes little difference where Americans purchase their prescriptions.

Tuesday, December 2, 2014

Foster Children in Experimental Servitude

Gabriel Myers, a heavily-medicated seven-year old foster child, committed suicide in 2009. Gabriel's autopsy report indicated that he was taking psychotropic drugs known to trigger suicidal actions. Gabriel's psychiatrist, Dr.Sohail Punjwan , had prescribed Vyvanse 50 mg, Symbyax 3/25 mg and Lexapro 10 mg. Symbyax is a combination drug product consisting of olanzapine, an antipsychotic and fluoxetine, a selective serotonin reuptake inhibitor.

Gabriel was under state custody from June 29 2008 to April 16, 2009, the time of his death. Gabriel Myers' case history is available here .

Florida officials suspected that Dr. Punjwan had placed Gabriel in his psychotropic drug trial and asked the FDA to verify whether Gabriel and other state-protected children were involved in Dr. Punjwan's pharmaceutical research. This is a telling piece of information for it means that protection agencies are not apprised of foster children's enrollment in government-sponsored testing regimens.

Because the FDA refused to provide said information George Shelton, secretary of the department of Children and Families told the agency that Florida was banning the employment of wards of state in drug trials. The FDA's response : the benefits can outweigh the risks.

In early 2010 the FDA advised Dr.Punjwan via letter that he had neglected to:
adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations. Your failure to conduct the requisite safety measures contributed to the unnecessary exposure of pediatric subjects to significant overdoses, which jeopardized the subjects' rights, safety and welfare.
Children seized by state protection agencies have routinely been subjected to federally-financed experimentation since 1989. This practice was approved by Congress at the suggestion of HHS Secretary Otis R. Bowen who 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).
It is not known what the legislators were thinking when they adopted Secretary Bowen's proposal but their action clearly violated Article IV of the Bill of Rights which states:
The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon probable cause, supported by oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized
Children are generally taken by juvenile courts to protect them from abuse and neglect. For the federal government to authorize state use of this population for experimental purposes is illegal under the law for it permits unreasonable searches.

Since 1989 millions of foster children have been forced to test pharmaceutical compounds for the benefit of the medical complex. Since this captive group has no voice in their medical servitude the U.S. is also breaching the Nuremberg Code mandate of informed consent.

To understand the plight of these state-controlled children one should consider the standard practices in clinical studies. The American Medical Association reports the following common procedures: blood draws, MRI's, allergy skin testing, electromyography, pharmacokinetic studies, testing of drugs believed to be safe in 500 adults and lumbar punctures with and without sedations. Upon occasion, researchers have surgeons fit children with gastronomy tubes to ensure drug delivery. Risks of harm to trial participants is high for more than 70% of the trials fail to meet safety/efficacy expectations.

Children believed to be suffering from somatoform [induced by parents] disorders are also often taken by the state and are then isolated in psychiatric facilities. Cases in point are Justina Pelletier and the other children who entered Boston Children's Hospital with difficult to define medical issues.

Course of action on the part of BCH staff: dispute the admitting diagnosis, claim parental medical child abuse [ Dr. Alice Newton ], have a judge agree [ Joseph F. Johnston ] and then take the child into experimental chambers. Researchers posit that isolation is beneficial to those believed to be suffering from somatoform disorders.

Dosing children's bodies with all manner of untested chemicals to market new drugs and incarcerating others in psychiatric wards to evaluate somatoform disorders is not acceptable.

U.S. policy—foster children as test vessels—abrogates provisions of the Bill of Rights, the Nuremberg Code and the Rome Statute of the International Criminal Court .

The International Criminal Court defines non consensual human experimentation as a crime against humanity.