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Obama Administration Seeks Approval to Test Anthrax Vaccine on Children

by Vera Sharav
Alliance for Human Research Protection

FYI / Action

A public meeting of the Presidential Commission for the Study of Bioethical Issues has been scheduled for Monday and Tuesday, January 14-15, to be held at the University of Miami Hospital Seminar Center, Florida:

The stated topic for discussion is “ethical issues associated with the development of medical countermeasures for children.”

http://www.gpo.gov/fdsys/pkg/FR-2012-12-26/pdf/2012-31037.pdf [1]

The Obama Administration is seeking approval to conduct morally impermissible, wholly non-therapeutic medical experiments that would expose healthy children to risks of serious harm.

Specifically, the Department of Health and Human Services is seeking to test the highly controversial, dangerous Anthrax vaccine, on children. Express Your Views to the Commissions Director, Hillary.Viers@bioethics.gov [2]

For over a year, the Commission has been attempting to find a rationale for endorsing a proposed government policy that would violate fundamental medical ethics principles. Principles mandated under the Nuremberg Code after the atrocities committed under the Nazi regime came to light.

Under US Law, research involving greater than minimal risk and no prospect of direct benefit to individual [child] subjects, is prohibited in healthy children. (45 CFR 46, subpart D).

If not stopped, the US government would override ethical and legal prohibitions by testing “medical countermeasures” on unprotected children who are legally incapable of giving informed consent. The government would subject healthy but socioeconomically deprived American children to unjustifiable risks of harm–to be exploited as human guinea pigs.

The overarching question–Not specified by the Commission or the Administration–is, WHOSE CHILDREN ARE TO BE SELECTED for experiments that violate ethical and moral standards? If history is a guide, underprivileged children’s best interest will sacrificed to serve as a means to an end that will benefit powerful commercial and government entities.

More than a decade has passed since the US was attacked by terrorists, Sept. 11, 2001.

No biochemical weapon has ever been shown to pose a threat to Americans–neither military personnel nor civilians.

The only exception was the mailing of anthrax laced envelopes in October, 2001, by a US military scientist, om a US military laboratory-who is now dead.

There is no evidence whatsoever of an anthrax threat to American children.

Therefore, those who even consider exposing children to the documented harmful effects of the anthrax vaccine suffer from a “moral deficit disorder.”

Express Your Views to the Commissions Director, Hillary.Viers@bioethics.gov [2]

Below are the warnings on the Anthrax Vaccine label.

Overarching all considerations is the question–

WHOSE CHILDREN WILL BE EXPOSED TO THE SERIOUS RISKS OF THE ANTHRAX VACCINE–WITHOUT ANY POTENTIAL BENEFIT FOR THEM?

WHOSE CHILDREN WILL BE USED AS HUMAN GUINEA PIGS?

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 [3]

EXCERPT
1. The vaccine is dangerous in pregnancy. (Pregnancy Category D*: evidence of harm exists) “BioThrax can cause fetal harm when administered to a pregnant woman.”

“Of women who received vaccine within 90 days of the estimated date of conception (n = 14), 2 spontaneous abortions and a first trimester intra-utero fetal death were reported, along with one report of a healthy term infant with mild right clubbed foot abnormality. ” page 6

Fifty-one pregnancies occurred during the trial. The package insert states, “Advise women of the potential risk to the fetus.” page 15

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”

Read the full article here: http://www.ahrp.org/cms/content/view/902/9/ [4]