[Note: On January 14 and 15, 2013 the Presidential Commission for the Study of Bioethical Issues held a meeting regarding the testing of an alleged “anthrax vaccine” on children. Representing the Natural Solutions Foundation, an international NGO dedicated to discovering, developing, documenting, disseminating and distributing natural solutions to pressing social issues, the Foundation President, Maj. Gen. Bert Stubblebine (UA Army, ret.), Medical Director, Rima E. Laibow, MD and Counsel, Ralph Fucetola JD, submitted comments objecting to the proposed “study” on ethical grounds. More about the Commission meeting here: http://healthimpactnews.com/2013/obama-administration-seeks-approval-to-test-anthrax-vaccine-on-children/ ]

Educate Decision Makers: http://tinyurl.com/NoChildAnthraxExperiments

To: The Presidential Commission for the Study of Bioethical Issues
Att: Hillary.Viers@bioethics.gov

Dear Director Viers:

I am writing to you as a concerned citizen and as the Medical Director of the Natural Solutions Foundation, the largest health freedom organization in the world. I am joined in this letter by the President of our Foundation, Maj. Gen. Bert Stubblebine (US Army, Ret.) and our Counsel and Ethicist, Ralph Fucetola JD. The Commission notice[1] states that the “Commission will continue discussing topics related to the ethical issues associated with the development of medical countermeasures for children.”

We address particularly the proposal to “test” an alleged Anthrax “vaccine” on children. These experiments would be entirely non-therapeutic and pose significant risk of harm to these subjects.

Under US law, research which involves any risk greater than minimal risk, provides no possibility of direct benefit to the child subject and involves healthy children is prohibited[2]. Yet for more than a year, the Commission has been seeking justification for medical experimentation which, had the US signed the Nuremberg Convention, would have been illegal under that document as well. Counsel Fucetola, in the Codicil to this letter further addresses International Law and the Declaration of Helsinki regarding this matter.

We hold that the United States government is bound by US law and by International Law and that individuals acting under color of law conducting unlawful experimentation on children are personally responsible for acts which may constitute Crimes Against Humanity and child abuse.

There are only ethical barriers to such experimentation, while there are no ethical justifications for it.

The proposed exposure of children to toxic material in the total absence of any threat of harm other than the experimentation is, in itself, an unwarranted and unjustified threat of harm to these children. The threat of harm to these children from weaponized anthrax simply does not exist. Even if it did, there is little or no likelihood that the Anthrax vaccine being tested would provide protection against a genetically modified organism, by definition of both a vaccine’s antigen specific antibody procuction and a weaponized organism.

What does exist is the very real threat of harm from this illogical, unjustified and wildly risky vaccine and vaccine “experiment”.

The FDA approved label for this commercial product cites a serious adverse event risk of 6% and notes that Gulf War Syndrome illness, an incurable, life-long, disabling and painful destructive auto-immune disorder, is suspected of resulting from the use of this vaccine. So the question is, fundamentally, whose children will the Commission permit to be exposed to needless – and pointless – suffering and death? The children of the elite, well-educated upper class whose lawyers will be at the ready to defend the rights of their client’s children? Or perhaps, as with the equally unethical pesticide studies by the EPA in Duval County, FL, the poor, the uneducated, the poorly nourished and the legally vulnerable children of the United States will be the target of this unconscionable experiment. Are these children more disposable than yours?

If not, meaning that the members of the Commission would submit their own children to the risks listed on the FDA approved label[3] then I would submit that those members are suffering from MDD, Moral Deficit Disorder, defined as:

“Deindividuation leading to immoral behavior. People will do things when they think they are anonymous or when they are in a group or when they see other people doing it even when they know its wrong or when they can blame someone else.”[4]

If the members of the Commission would not submit their own children to this experimentation, they have made the point clear: there is no ethical justification for this experimentation which would not be carried out on children precious to the Commission but could be carried out on children whose value they hold in less esteem.It is widely recognized that vaccination is an uninsurable risk. That is why the Federal Government’s Vaccine Injury Compensation Program exists (National Childhood Vaccine Injury Act of 1986 (Public Law 99-660)). “Informed consent” for an uninsurable harm is hardly informed!

Biothrax is formulated to contain 1.2 mg/mL aluminum, added as aluminum hydroxide in 0.85% sodium chloride. The final product is formulated to contain 25 mcg/mL benzethonium chloride and 100 mcg/mL formaldehyde. These substances are particularly dangerous to children and providing them to children by themselves would constitute malpractice if not for the exemption from liability provided by PL 99-660. While Congress may have deprived Americans of their legal redress against vaccine harms, it cannot protect physicians and others involved in experimentation on children of the moral approbation of all disinterested individuals.

We say to those who would conduct these experiments: SHAME ON YOU.
Children cannot offer informed consent on their own behalf as to whether they are willing to take the well-established, but uninsurable risk associated with a product whose safety in the pediatric population has not been established but whose dangers have.

On behalf of our hundreds of thousands of supporters, my Co-Trustees and of myself, I cannot urge you strongly enough to abandon this unethical plan before you give your approval to testing, once again, Anthrax Vaccine in children. On behalf of ourselves and the children this experiment would victimize, we petition for redress of grievances and demand an immediate halt to unethical experimentation on children and other children.

What positive ethical considerations can there be for such testing? Our concerned supporters and I ask the Commission:

• Has a single child died of anthrax in the United States within modern scientific memory? Epidemiological evidence makes it clear that the answer is “No.”
• Is the anthrax vaccine safe? Abundant documentation of the chronic degenerative auto immune conditions experienced by veterans and others exposed to this vaccine makes it clear that the answer is “No.”
• Is the anthrax vaccine effective? Clinical results make it clear that the answer is “No”, whether or not an antibody response is produced since scientific studies from the NIH and elsewhere through the entire antibody hypothesis of vaccine protection into serious question.
• Is anthrax a threat to children or others in the United States? The answer is a clearly “No.”
• Does anthrax present a real rather than hypothetical threat worthy of exposing children to a major threat for illusory and illegal scientific inquiry? The answer is “No.”

The Natural Solutions Foundation Trustees, supporters and I personally urge the Commission to decide definitively on behalf of the safety and security of the US population, and particularly its children, that experimentation which exposes healthy people to risk without possibility of discernible gain to them is unethical and, following US law, illegal.

Yours in health and freedom,

Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org

Codicil – Ralph Fucetola JD

The World Medical Association, an internationally recognized nongovernmental organization (NGO) adopted the Declaration of Helsinki[5] to record existing International Law binding on all nations with regard to Human Experimentation. The Declaration implements the Geneva Conventions with concerning the treatment of civilian populations.

With regard to the question of “testing” the alleged “Anthrax Vaccination” on children, international norms are quite clear. In the circumstances described by the would-be experimenters, and explained by Dr. Laibow above, there are only ethical objections to the experiments; there are no ethical excuses for this experimentation.

Two specific clauses of the Declaration, especially when read in conjunction with the entire Declaration, as required thereby, make it absolutely clear that the proposed experimentation cannot be considered ethical by any disinterested individual

The first relevant clause reads:

“9. Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence…

The second relevant clause:

“29. Research involving subjects who are physically or mentally incapable of giving consent… may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorized representative… provided … the study has been approved by a research ethics committee…”

It is therefore my considered professional opinion that conductingthe proposed experiments violates ethical norms as well as US and International law. [rf3]

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Footnotes

1. http://www.gpo.gov/fdsys/pkg/FR-2012-12-26/pdf/2012-31037.pdf
2. 45 CFR 46, subpart D
3. FDA-Approved Label Warning (31 JAN 2002)

ANTHRAX VACCINE ADSORBED (BIOTHRAX™) EXCERPT

“Approximately 6% of the reported events were listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening.

The serious adverse events most frequently reported were in the following body system categories: general disorders and administration site conditions, nervous system disorders, skin and subcutaneous tissue disorders, and musculoskeletal, connective tissue and bone disorders.

Anaphylaxis and/or other generalized hypersensitivity reactions, as well as serious local reactions, were reported to occur occasionally following administration of BioThrax. None of these hypersensitivity reactions have been fatal.

Other infrequently reported serious adverse events that have occurred in persons who have received BioThrax have included: cellulitis, cysts, pemphigus vulgaris, endocarditis, sepsis, angioedema and other hypersensitivity reactions, asthma, aplastic anemia, neutropenia, idiopathic thrombocytopenia purpura, lymphoma, leukemia, collagen vascular disease, systemic lupus erythematosus, multiple sclerosis, polyarteritis nodosa, inflammatory arthritis, transverse myelitis, Guillain-Barré Syndrome, immune deficiency, seizure, mental status changes, psychiatric disorders, tremors, cerebrovascular accident (CVA), facial palsy, hearing and visual disorders, aseptic meningitis, encephalitis, myocarditis, cardiomyopathy, atrial fibrillation, syncope, glomerulonephritis, renal failure, spontaneous abortion and liver abscess. Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, musculoskeletal system.

Reports of fatalities included sudden cardiac arrest (2), myocardial infarction with polyarteritis nodosa (1), aplastic anemia (1), suicide (1) and central nervous system (CNS) lymphoma (1).
Revised package insert (May 2012) provides additional cause for alarm.
http://www.biothrax.com/prescribinginformation_biothrax_us.pdf EXCERPT:

2. The Gulf War Syndrome definition remains a reported adverse event in the most recent version of the package insert: ”Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition, and musculoskeletal system.” page 9

3. The vaccine hurts more than other vaccines. ”Up to 11% of subjects rated the brief pain or burning they experienced immediately after vaccine injection as 8 out of 10 or greater.” page 5

4. The “Information for Patients” page states, on page 16: “What are the possible or reasonably likely side effects of BioThrax?

• Pain, tenderness, redness, bruising, or problems moving the arm in which you got the shot
• Muscle aches • Headaches • Fatigue • Fainting”

4. http://markhamsbehavioralhealth.blogspot.com/2010/01/moral-deficit-disorder-caused-in-part.html

5. The Declaration of Helsinki – http://www.wma.net/en/30publications/10policies/b3/