Obama wants to test anthrax vaccine on children

A call to action from the Alliance for Human Research Protection:

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Advancing Honest and Ethical Medical Research
www.ahrp.org

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.”

Click to access 2012-31037.pdf

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

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

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.

Click to access prescribinginformation_biothrax_us.pdf

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”

11 thoughts on “Obama wants to test anthrax vaccine on children”

  1. Anthrax is naturally present in soils worldwide. Infection is rare when compared to other globally distributed disease causing organisms such as Streptococcus a. (which also happens to be living happily in/on everyone of your bodies and mucosa right now), Klebsiella, Staph, various fungal organisms, Influenza, cold viruses, and so on. Yet Bacillus anthracis is almost as widely distributed.

    Aerosolization of this organism will likely cause disease and death due to inhalation of a large number of the organism at one time. However, as soon as it is settled back to the soil, goes back into spore form for a long sleep (estimates of >100 years if necessary), then the problem is over.

    At least that’s what I remember from microbiology.

  2. Gee, I really think the Soetoro Admin should test it on themselves first!
    And the DHHS, too.

    And finally, I think, they are so bored and have reached the point where they don’t know what other games to play, so they should
    ALL KILL THEMSELVES,
    and let the rest of us, live our lives in peace.

    We’d be so much better without them!

  3. In reading the final report and recommendations from the ACIP [http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5906a1.htm?s_cid=rr5906a1_e] and the Committee’s previous notice on using the anthrax vaccine in reponse to terrorism [http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5145a4.htm], I was surprised how few studies have been done on this vaccine to demonstrate efficacy with inhaled anthrax, even though the vaccine has been around for decades. The Dept of Homeland Security’s and WHO’s computer models of aerosolization dispersion due to bioterrorism are riffe with credibility problems, unknowns, scary speculations, and still concluded that the magnitude of disease exposure after a potential release is unknown. How this new threat is being couched is remniscent of the unsound scare tactics surrounding a bird flu epidemic a few years ago.
    The anthrax vaccine requires 5 doses plus annual boosters as its protection appears to be short lived, and it is not licensed for post exposure use. Prophylactically vaccinating the entire population is not currently recommended, nor would it appear to be reasonable course of action for a theoretical threat, especially given the potential health risks and costs.
    Should a release (exposure) occur, antibiotics are reportedly effective in preventing the development of the disease (given for 60 days) and are a much more tested and safer course of action to protect children, pregnant women and nursing mothers.
    Most parents given the facts will probably feel that just because there is no data on this vaccine in children is not sufficient reason to test it on children.

  4. One of my friends was actually at the last conference on this a few months ago. There was a great deal of discussion about what was effectively trivialities (a problem common with conferences of regulators and academics with too few field doctors). However, at the end, a significant point remained that the anthrax vaccine has never been tested on children. There is literally no data on this whatsoever for children. Almost all the data is for virile young men (soldiers). Children (especially infants) respond quite differently than adults.

    On the other hand, an Anthrax terrorist attack will be relatively small scale. Unlike a highly virulent disease like smallpox, anthrax is not highly contagious. We can expect at most a few dozen children to be affected, a smaller number than is necessary for any sort of medical trial.

    Lacking a serious threat to a mass group, I have to agree that it is not a worthwhile risk to study the anthrax vaccine’s effectiveness. If such an event does happen, then we will have to test the vaccine on a live basis and monitor the first group of victims to see whether the treatment was effective. However, it is a not an instantly dismissible case, and it is a far cry from the absolutely pointless tests that you are suing over, Milloy.

  5. I find this a little bothersome—anthrax vaccine is not a benign thing—sometimes I see anthrax reactions that are very troubling in soldiers—no deaths or serious illness, but just big reactive areas John Dale Dunn MD JD Consultant Emergency Services/Peer Review Civilian Faculty, Emergency Medicine Residency Carl R. Darnall Army Med Center Fort Hood, Texas Medical Officer, Sheriff Bobby Grubbs Brown County, Texas 325 784 6697 (h) 642 5073 (c)

  6. Here’s an unlikely but interesting conspiracy theory: maybe he just wants the kids protected so when/if anthrax is used as a bio weapon there will be lots of orphans alive to be raised by the state. The government can indoctrinate them 24/7 and justify more government spending and employees. Who would oppose help for orphans?

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