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US Public Health Officials Back Pediatric Anthrax Vaccine Experiment
Posted: 3/12/2013 9:45:54 AM | with 9 comments

The U.S. Department of Health and Human Services (DHHS) and the nation’s sole manufacturer of anthrax vaccine, Emergent BioSolutions, are making plans to go forward with an experimental clinical trial testing anthrax vaccine on American infants and children. Last month, the Alliance for Human Research Protection (AHRP) issued a strongly worded, evidence-based letter to the Presidential Commission for the Study of Bioethical Issues protesting pediatric trials using BioThrax anthrax vaccine for the purpose of proving the vaccine is safe and effective to give to infants and children.[1]  

BioThrax Vaccine: A Military Mandate
 
Emergent BioSolutions, formerly known as BioPort Corp., is the sole source supplier of anthrax vaccine to the U.S. military. All U.S. military personnel are required to take a series of the company’s BioThrax anthrax shots. Despite continuing reports that the vaccine is causing a high number of reactions, injuries and deaths, the Department of Defense (DOD) maintains that all soldiers and civilian military personnel must get a series of anthrax vaccinations based on a theoretical threat of a future bioterrorism attack using weaponized inhalation (aerosol) anthrax.
 
Anthrax is a non-communicable infection usually occurring in cows, horses, sheep and goats and transmitted to humans through contaminated animal by-products and soil. Anthrax has never been used as a bioterrorism weapon by any nation.[2] There are between 10 and 29 million doses of anthrax vaccine in U.S. stockpiles, but every year the Centers for Disease Control (CDC) and Department of Homeland Security throw out about 2 million doses of anthrax vaccine (worth $48 million) that have passed the expiration date.[3]   

BioThrax Vaccine: “A Dangerous Vaccine”
 
Along with AHRP, the National Vaccine Information Center (NVIC) is also on public record since 2011 as opposing proposed anthrax vaccine experiments on children. The 2013 letter to the Presidential Commission, written by AHRP President Vera Sharav and Board Member Meryl Nass, MD, states that the anthrax vaccine’s “effectiveness after exposure to inhalation anthrax is unknown, and the lack of a reliable animal model makes any calculation of effectiveness and dosing impossible. What is known is that BioThrax is a dangerous vaccine. The FDA-approved 2002 label states: 5% to 35% of adults who were vaccinated suffered adverse events.”
 
The AHRP letter comes after several years of meetings in which federal officials and consultants debated the risks and ethics of enrolling infants and children in experimental trials and injecting them with the controversial vaccine. BioThrax anthrax vaccine was first associated with hundreds of cases of chronic brain and immune system damage and death suffered by soldiers in the Gulf War, who received a series of anthrax shots along with many other vaccines.
 
BioThrax Vaccine: Subject of Lawsuits
 
In 2004, a U.S. District Court Judge issued an injunction ordering the Department of Defense (DOD) to stop giving BioThrax anthrax vaccine to U.S. troops because the FDA had not properly tested and licensed the vaccine as effective against weaponized inhalation anthrax.[4]  However, the DOD eventually invoked an “Emergency Use Authorization” created under post 9-11 Bioshield legislation passed by Congress and circumvented the court injunction in order to continue forcing soldiers to get BioThrax vaccinations without voluntary, informed consent.
 
In March 2005, NVIC joined with AHRP and military veterans groups in an amicus brief filed in a U.S. District Court in John Doe #1, et al v. Donald Rumsfeld opposing forced use of experimental anthrax vaccine by U.S. troops in violation of the informed consent ethic. In December 2005, the FDA issued a “Final Order” declaring that BioThrax vaccine was effective against inhalation anthrax, without conducting additional appropriate tests, and the federal court injunction was lifted.
 
Creating Civilian Markets for Bioterrorism Vaccines
 
In October 2011, the National Biodefense Science Board (NBSB) voted to endorse pediatric anthrax vaccine trials in the U.S. with the justification that government officials need to know whether the vaccine is safe and effective in children in case there is ever a future bioterrorism attack involving weaponized inhalation anthrax.[5]  At a July 2011 NBSB public meeting, NVIC’s director of research and patient safety, Vicky Debold, RN, PhD, stated NVIC’s opposition to the pediatric trial:
 
“NVIC is deeply concerned about the safety of pre-event testing of BioThrax anthrax vaccine in pediatric populations in light of the continuing adverse event reports in previously healthy adult men and women, who have taken the vaccine. Without a credible, substantiated threat of weaponized anthrax being used against the U.S. civilian population, NVIC finds it hard to justify this kind of experimentation on American children.”[6]   
 
The National Biodefense Science Board, which is housed in the Department of Health and Human Services (DHHS), was created by Congress in 2006, under the “Pandemic & All-Hazards Preparedness Act.” The law fosters a public-private partnership between the federal government and the pharmaceutical industry to develop new “bioterrorism” vaccines.[7]      
 
Highlights of AHRP Letter Focus on Ethical Violations
 
In their Feb. 18 letter, Vera Sharav and Dr. Meryl Nass appealed to Dr. Amy Gutman of the Presidential Commission for the Study of Bioethical Issues to help put a stop to the proposed anthrax vaccine trials on American children. Stating that they are making “the case that the proposed pediatric anthrax vaccine trial… involves greater than minimal risk and is unethical and unapprovable in the absence of a clear and present danger to children,” the letter outlines a number of basic flaws associated with the anthrax vaccine, such as: 
 
  • FACT: No bioterrorism events have happened since 2001, due to anthrax or any other biological agent. Anthrax is only one of dozens of possible agents that could be used as biological weapons by terrorists or foreign militaries—or only one of hundreds more that could be genetically engineered.
  • FACT: of many thousands of people exposed to anthrax spores in 2001, antibiotics prevented illness in 100% of those treated after exposure. Five people died, their cases unrecognized until very late. There was no additional benefit from anthrax vaccine, which was accepted by less than 2% of those who used antibiotics.
  • FACT: Due to lack of an animal bridging model for anthrax vaccines, there are only immunogenicity data in humans, not human efficacy data. Immunogenicity data cannot reliably predict efficacy for this vaccine, either in adults or children.
  • FACT: Possibly 30,000 people were exposed to spores from the anthrax letters in 2001. Most took antibiotics alone; only 198 accepted vaccine. Indeed, according to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC): “No cases of anthrax have been detected among persons recommended to take antimicrobial prophylaxis after the terrorist attacks of 2001.”[8]
  • FACT: No other country in the world mandates that its troops be vaccinated with anthrax vaccine. Canada, Australia and the United Kingdom all began anthrax vaccination of their troops during the Gulf War, but all three vaccination programs were soon cancelled.
  • FACT: The proposed anthrax vaccine experiment indisputably poses greater than minimal risks with no direct benefit for the specific children involved. This government-initiated experiment fails to meet the statutory standard in Federal regulations for exposing children to greater than a “minor increase over minimal risk” in research.FACT: The antibody data to be gained from a pediatric trial will thus be clinically and scientifically uninformative. The proposed experiment will be scientifically useless and unnecessary—thereby violating ethical principles of the Nuremberg Code and Federal regulations.
  • FACT: The proposed trial cannot answer meaningful safety questions—which would require using thousands of children. The inescapable conclusion, therefore, is that data to be obtained from the proposed pediatric experiment will have no scientific or clinical value. Undertaking such trials is, therefore, unethical and unapprovable under US statute.
The letter closes with a challenge to the Commission: “Your decision will draw a moral line in the sand—either you uphold children’s statutory protected human rights—or you provide the Administration with a disingenuous rationale for circumventing statutory safeguards enacted to protect children from exploitation as human guinea pigs. Which legacy do you wish to leave?”
 
The Alliance for Human Research Protection (AHRP) is a national network of lay people and health professionals dedicated to advancing responsible and ethical medical research practices.
 
Read the entire AHRP Feb. 18, 2013 letter here.

References

[2] NVIC.org. Anthrax. 2013.
[4] M. Kaufman. U.S. Barred From Forcing Troops to Get Anthrax Shots. Washington Post Oct. 28, 2004.  
[5] R. Stein. Federal advisers endorse testing anthrax vaccine in children. Washington Post Oct. 28, 2011.
[6] Debold V. Public Comment on Behalf of NVIC Opposing Pediatric Anthrax Vaccine Trials. National Biodefense Science Board Public Engagement Workshop Meeting, Anthrax Vaccine Working Group July 7, 2011.
[7] U.S. Department of Health *& Human Services. National Biodefense Science Board (NBSB). March 7, 2013.
Posted: 3/12/2013 9:45:54 AM | with 9 comments





  
Comments
E
This is just pure evil. I am sick for the uninformed who will be used for this horrible "experiment!" What is the matter with people? Wake up and research ANYTHING that goes into your body! God save America.
3/13/2013 2:39:39 PM
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Suzanne Coulliette
What can we do to stop this?
3/13/2013 2:58:44 PM
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Tyranny
Thank you to NVIC,AHRP and Dr Nass. FACT: Bruce Ivans is most likely NOT Responsible for the Weaponized Anthrax attacks on Congress. The DOD ran covert experiments on it's own troops, even the NAZI's did not run medical experiments on their own troops in combat. The banker funded pharmaceutical, military, industrial complex is certainly behind this egregious unethical experiment.
3/13/2013 6:52:54 PM
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Michele
This is unconscionable. That our own US government would allow a vaccine to be tested on any infant is beyond disgusting. The fact that it has been required for US troops is bad enough, but to actually inject babies with anthrax vaccine is outrageous. The US government has no conscience, and obviously no oversight from people with consciences.
3/14/2013 7:06:19 AM
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Dorothy R Brant
To me this is despicable, outrageous, deplorable, ill-advised to say the least, should be unconstitutional and I cannot understand it. My granddaughter's husband is in the Navy and what if they give this to him and he dies and leaves my granddaughter and her three children without a father? Who will take care of them let alone replace a wonderful husband and father? What if years down the line because of getting this shot something terrible happens to him physically? I am truly shocked that our government would allow little defenseless babies be experimented on.
Who the heck is allowing this to happen where is the overseers to protect our people? What can one older lady do about this travesty? I pray for my country and I try to vote for good people, I am truly sickened about this.

Dorothy R. Brant
a Mom, grand mom and great-grand mom feeling like my America is going down the drain morally and ethically
3/23/2013 3:50:43 PM
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Andria Myers
And my baby's insurance sends me a letter so far reminding me to make sure my son gets "ALL" the recommended vaccines. Hmmmmmm!If they recommend AIDS vaccine, and add it to the childhood immunization schedule, he must then get it? If they recommend cockroach flu vaccine, fly rash vaccine, west nile mosquito virus vaccine,catapillar cough vaccine he must then get them? Seems to me they are adding so much to the childhood immunization schedule, to be given so soon, with so little research if any at all. I fear the human body won't be able to function on its own eventually. It will be so influenced and controlled with medicine. So damaged by unwanted and unneccessary prophylactic/preventative medicine that we are going to have a generation so chronically ill, dependent on medicine and dying of the effects of slow poisoning. The next generation will be generation prescription or prescription generation. Alzheimer's disease, lupus, MS, GBS, Diabetes, autoimmune disorders, cancers-So many children diagnosed here with cancers than anywhere else in the world. So many children with questionble and strange mental impairments.
Isn't there a conflict of interest when the ones that are manufacturing and marketing their own product, are the same ones funding their own research? Shouldn't it be unbiased research.
3/23/2013 11:47:36 PM
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Melanie Lanier
I, myself, am a victim along with my 21 year old son who was 3 months trimester into my pregnancy. I was forced to take a series of 3 injections during 6 months while serving in the Desert Storm War. No one is wanting to take responsibility for my son's adverse reactions. Nor mine so far. Everyone is playing "stupid" to the whole situation. I had no idea there was so much information on this topic until I was so frustrated, I finally tried the internet. If anyone knows any connections for this kind of situation, please let me know.

Thank you
4/1/2013 5:25:21 PM
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Christina
I truelly wish I would have known about this laswuit. I had the series of anthrax vaccinaton shots from 1998-1999. The last one I had to get was just about 2 months before I found out I was pregnant with my first son. I still believe that the Anthrax vaccine is responsible for the problems my son faces every day of his life. I have taken him to numerous doctors. They all say he has a high functioning autism. I pay every day of my life for serving my country. Unfortunately my son does too.
4/20/2013 1:21:11 PM
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Sallie O. Elkordy
BAN VACCINES 2013

When I think of the lowest point in our Country's history, I will always think of injecting babies with Anthrax.

I wrote to The Presidential Commission on BioEthics prior to their January 14th and 15th 2013 meetings, (and successfully recruited 40 others to do likewise).

My own letter was brief. "Children should not be within 10 miles of Anthrax, let alone injecting it directly into their bloodstreams. Stop this immediately!"

No one listened, although I received confirmation that my letter had been received. Where do ETHICS enter into this discussion? Perhaps a lack thereof.

"I DO NOT CONSENT!", Sallie O. Elkordy
http://BillionToddlerMarchForSurvival.blogspot.com
6/22/2013 3:57:53 PM
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