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 PharmacyChecker.com.

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.


Saturday, November 8, 2014

Brittany Maynard's Suicide: The Right to Choose Death



Brittany Maynard's reflections on why she was ending her life:
I made my decisions based on my wishes, clinical research, choices, discussions with physicians, and logic.  I am not depressed or suicidal or on a ‘slippery slope.’ I have been in charge of this choice, gaining control of a terrifying terminal disease through the application of my own humane logic.
Most religions, specifically Catholicism, condemn Ms. Maynard's action as a violation of the Fifth Commandment — "Thy Shall not Kill." Interpreters of the Bible have determined that the homicide dictate is also applicable to suicide.

When the Bill of Rights was added to the Constitution in 1791 the authors recognized the likelihood that religious leaders would attempt to influence legislative matters and so Article Three affirmed that Congress "shall make no law respecting an establishment of religion." The founding fathers knew from past experience that religious disputes cripple governments.

Be that as it may, Congress and state legislative bodies have frequently passed Christian-inspired laws. These controlling measures violate Article Three and civil rights. Most state laws, for instance, forbid physician-assisted suicides. Some other laws based on religious belief (Canon Law) include divorce , reproduction, and sexual preference prohibitions. From the Catholic Church's perspective homosexuality, birth control/abortion, divorce and suicide are not issues of choice.

President Reagan formalized relations with the Holy See in 1984. Those serving as Vatican ambassadors, if Catholic, must agree with the church's position on life issues.

As intended Brittany Maynard provoked a fiery discussion on the right to die while under medical supervision and as expected many dispute her course of action. For instance, Msgr. Ignacio Carrasco de Paula, president of the Pontifical Academy for Life, called Oregon's Death with Dignity Law reprehensible.

The Catholic Church is a misogynistic institution with unresolved pedophilia and forced labor issues.

If Msgr. Carrasco and his employer were in charge of American affairs, women would not be eligible for political office and personal choice laws would be abolished.


Tuesday, November 4, 2014

MSN's "No Choice News" Homepage

On September 30, 2014, Microsoft terminated its "My MSN" homepage service and substituted its own selected news feeds. The consequence: MSN now controls the source of news for its patrons.

Prior to the change MSN homepagers could choose their news outlets which might include The Washington Post, The New York Times, The Wall Street Journal, The Guardian, Fox News and Al Jazeera.  Comparing news reports on various issues was an easy endeavor.

MSN's new rolling photo format could be called the three stooges of news, lots of slapstick, little substance. Phooey!



Sunday, October 26, 2014

The Taking of Justina Pelletier by Judge Joseph F. Johnston


Juvenile judges in Massachusetts and other states routinely sever parental rights on the grounds of wrongful medical treatment. Suspicions of medical child abuse are generally brought to the courts' attention by research hospitals who upon occasion have pursuits outside the well-being of the child.

When the intervenors are successful the institutions are permitted to keep the children, proceed with divergent courses of medical treatment and bill Medicaid for the cost. If the now ward of state has a condition of interest to the research facility the child may be selected for experimental therapies such as psychiatric isolation. Parents, foster children and their former physicians have no voice in these decisions.

Circumstantial evidence suggests that Boston Children's Hospital was engaged in somatoform disorder research when the psychiatric staff filed a medical child abuse complaint against Justina Pelletier's parents. Justina was not the only child targeted by the hospital. The Boston Globe reported that at least five other children over an eighteen-month period preceded the path of Justina in Boston Children's Hospital medical child abuse complaints.

A lawsuit filed in May 2014 alleges that the parents of a child who was receiving treatment at Boston Children's Hospital in June 2012 were put on the state abuse watch list and were then threatened with loss of their daughter if they did not agree to her psychiatric confinement.

The taking of Justina Pelletier by Judge Joseph F. Johnston on the basis of a medical child abuse allegation is an example of the unchecked power of hospitals, the Department of Children and Families and the Massachusetts juvenile court system.

Although medical child abuse was not addressed by the U.S. Court of Appeals for the First Circuit in their ruling against the Department of Children and Families et al in March 2014 the court found that the Massachusetts child protection agency's practices were "conscience shocking" and were depriving foster children of constitutional protections.

The decision by Judge Johnston to allow the incarceration of Justina Pelletier, a fourteen-year-old foster child with no history of mental issues, meets the Supreme Court's test of "shocks the conscience."

The following is a brief recap of the Pelletier travesty as reported by The Boston Globe. Dr. Alice Newton and Judge Joseph F. Johnston were the parties responsible for Justina's sixteen-month captivity.

Dr. Alice Newton, head of Boston Children's Hospital child protection team, notified the state Department of Children and Families in February 2013 that their newly-admitted patient, Justina Pelletier, was a victim of medical child abuse. Swayed by Dr. Newton's certainty Judge Joseph Johnston held within days that Justina Pelletier had been harmed by her parents, Lou and Linda Pelletier. The rationale for taking Justina: the parents were permitting Dr. Mark Korson of Tuft's Medical Center to treat their daughter for a mitochondrial condition.

Dr. Newton conveniently neglected to tell Judge Johnston that Boston Children's Hospital treats mitochondrial disorders and performs the highly criticized cecostomy surgery.

If Lou Pelletier had obeyed Judge Johnston's gag order, Justina may have remained a ward of the state until her eighteen birthday.
Former rulings make it clear that Judge Johnston erred when he chose to separate Justina from her parents and place her under state custody for the reasons cited by the Supreme Judicial Court of Massachusetts in Sevigny’s Case, 337 Mass. 747 (1958). :
The courts are not to determine which side of a medical dispute is sound where each side is supported by reason and logic.
When Judge Johnston returned Justina to her parents on June 18, 2014 the contretemps became moot. But the question remains, was Judge Johnston conducting a kangaroo court ?

Wednesday, October 15, 2014

Boston Children's Hospital Threatens Parents with Medical Child Abuse


The state practice of revoking parental rights based on medical child abuse [disparate medical opinions] is being legally challenged by the parents of a child who received treatment at Boston Children's Hospital in June 2012.

Nature of the Action:
The Massachusetts Department of Children & Families ("DCF") has violated and continues to violate the fundamental rights of parents under the Due Process Clause of the Fourteenth Amendment to the U.S. Constitution, to choose which healthcare providers will examine and treat their children. DCF has unconstitutionally expanded the concept of "medical child abuse" without sufficient and justifiable standards to intrude on sincere, vigilant and loving efforts by parents who face competing diagnoses and different views on the medical condition of their children.
This May 2014 civil complaint bears an uncanny resemblance to the case of Justina Pelletier. Both children entered Boston Children's Hospital with complex medical histories and both were reevaluated and subsequently diagnosed with undifferentiated somatoform disorders. The Boston Globe reported in December 2013 that Boston Children's Hospital has a history of alleging medical child abuse and then subjecting the taken children to psychological therapy.

Abuse allegations are self serving because when the hospital is successful in its claims, the state permits the institution to keep the children, dismiss previously established diagnoses and proceed with its own judgment. Elizabeth Wray was another child whose parents were charged with medical child abuse while their daughter was receiving care at BCH. In the cases referenced the new diagnoses are psychological in nature.

Rob Graham, Boston Children's Hospital spokesman has refuted claims that the hospital conducted research on Justina Pelletier. In a written response to the Hartford Courant, Graham said that the "allegations that research was conducted on the patient are baseless and patently false."

Undifferentiated somatoform disorders are difficult to identify and manage conditions. Research on the subject suggests that some patients may require psychiatric confinement and intensive cognitive behavioral therapy. Dr. Alice Newton , head of Boston Children's Hospital child protection team and orchestrator of the Justina Pelletier custody petition told The Boston Globe that these drastic measures were worthwhile. It is likely, but yet unproven, that Boston Children's psychiatric staff were engaged in somatoform clinical research.

According to the complaint Dr. Gary Gosselin, Boston Children's Hospital Inpatient Psychiatric Medical Director, advised the parents that their daughter would be placed under state jurisdiction if they failed to agree with the hospital's orders. With no suitable options the parents agreed to: accept the somatoform diagnosis, pursue no further second opinions and commit their daughter. The forced isolation worsened the child's condition, she was released but remained subject to DCF's supervision.

Intimidated by Boston Children's Hospital dictates and the institution's connection to the Department of Children and Families, the parents are asking for injunctive relief to continue to seek other medical advice without fear of losing their daughter to protective custody.