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.