On Friday, October 28, the National Biodefense Science Board (NBSB), a government-appointed panel of "experts" voted its approval (12 to 1) for the government to proceed with an unconscionable medical experiment that would expose healthy US children to the risks of the anthrax vaccine, a vaccine which offers absolutely no direct benefit, but whose risks include serious adverse reactions such as Stevens-Johnson syndrome,  neurological disorders, disability and death. http://www.gao.gov/new.items/d07787r.pdf

The list of NBSB members  who voted to endorse the experiment (under the guise of "protecting children") as well as the ex-officio government agency officials who concurred, is posted at: http://www.ahrp.org/cms/content/view/836/9/   

Under US regulations (45 CFR 46, Subpart D) children may not be exposed to risk if a medical experiment does not offer them a direct benefit. 

Don't be misled by government propaganda about the risk of an anthrax attack-- a myth perpetuated by the media:

• Anthrax is NOT CONTAGIOUS--it cannot be spread from person to person.
  
• Anthrax has never posed a threat to the general public; the only people at risk are research laboratory staff who handle anthrax bacteria.
  
• The Center for Disease Control, until recently, recommended vaccination "only for those at high risk, such as workers in research laboratories that handle anthrax bacteria routinely."  
• The current FDA label (2008) states: "the vaccine is licensed for use only in adults between the ages of 18 and 65, who are at high risk for exposure to anthrax bacteria."

 The NBSB recommendation was made despite its own report acknowledging that:

“Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration.”

“There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit.”

Their justification is without substance, relying on a hypothetical, highly exaggerated risk from an unlikely event:

"Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security.” 

What evidence exists of any "national and potentially global threat from anthrax"?

One is reminded of the purported "weapons of mass destruction" which never materialized, but served as our government's excuse for going to war against Iraq.  

Since 2004, the Dept. of Health and Human Services, which convened the NBSB panel, has overseen Project BioShield to develop and stockpile vaccines and treatments as medical countermeasures to hypothetical bioterrorist attacks. One goal was to develop a replacement for the controversial, 50 year old anthrax vaccine developed by the US Army, which admittedly has severe side effects.

 The cover story of Sunday's New York Times Magazine, "Ten Years After the Anthrax Attacks, We Are Still Not Ready," by Wil Hylton exposes the lack of leadership, confusion, and even mutual hostility among US government officials charged with developing biodefense countermeasures:

 "Last year, two separate review boards evaluated the state of the country's biodefense program, and each report came back scathing." They described "ballooning" government bureaucracy, "lack of coherence," "lack of prioritization," "lack of synchronization"--and colossal waste.

 "Ten years after the anthrax attacks, and with more than $16 billion committed to countermeasure development, there is still broad disagreement among officials over whether the stockpile should include other vaccines."

"[The] challenge is not made easier by the personal hostility that has emerged among many current program heads — some of whom have close ties to the competing companies they oversee. In the course of several months of reporting, I heard senior officials from each of the major countermeasure agencies question the motives and professional credentials of the others, sometimes in a manner involving spittle. At times it seemed that the most virulent pathogen in biodefense was mutual hostility, and everybody had it." 

Of particular concern is the motive and professional credentials of the DHHS Assistant Secretary, Nicole Lurie, who proposed the anthrax vaccine trial in children. She did so, despite knowing that the vaccine is mired in controversy, despite knowing the health problems associated with it, despite the government's sweetheart deal with its sole manufacturer, Emergent BioSolutions, all common knowledge within the biodefense community.

The panel's 12 to 1 recommendation favoring DHHS’ request to proceed with the pediatric anthrax vaccine trial--with the proviso that another "appropriate" panel be convened to determine the ethical viability [a requirement under 45 CFR 46.407]--raises serious questions about the integrity of government-convened committees who rubber stamp dubious government initiatives and policies. 

Knowledgeable critics believe this vote demonstrates the insidious influence federal biodefense funding exerts on academics and physicians who can be counted on to sanction even the most egregious, ill-conceived government initiative and lend credence to hypothetical, unsubstantiated risks.

FDA's latest label warnings (2008) states:

"Since the risk of anthrax infection in the general population is low, routine immunization is not recommended."
"Safety and effectiveness of BioThrax have not been established in pregnant women or nursing mothers, or in pediatric or geriatric populations"

Notwithstanding FDA's  licensure for limited usage indications of the vaccine--and its explicit statement that the vaccine had NOT been tested in geriatric populations--Daniel Fagbuyi, who chaired the NBSB Anthrax Vaccine Working Group, and is the medical director of disaster preparedness and emergency management at Children's National Medical Center in Washington, D.C., falsely implied that the vaccine had been tested and approved for elderly populations:  

"We can take care of Grandma and Grandpa, Uncle and Auntie. But right now, we have nothing for the children.” 

An incisive article discussing the anthrax vaccine and the NBSB’s odious recommendation was published by Forbes, titled "The Anthrax Vaccine Boondoggle," by Steve Salzberg , Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins University's School of Medicine. 

Kudos to The Washington Post for its coverage of two of the three public hearings of the National Biodefense Science Board (NBSB), which informed the public about the Obama Administration's proposal to test the safety and efficacy of the highly controversial anthrax vaccine on healthy US children.

See:  Federal Advisers Endorse Testing Anthrax Vaccine in Children, by Rob Stein , published October 28:


See also: Public Citizen letter to DHHS Secretary , Kathleen Sebelius (Nov. 1, 2011) urging her to reject the National Biodefense Science Board's recommendation to conduct pre-event clinical trials of the anthrax vaccine in children:

Vera Hassner Sharav

FORBES

The anthrax vaccine boondoggle

By Steven Salzberg

+ Comment now

The anthrax vaccine is a truly bad idea. The U.S. has wasted billions of dollars on it, and it just seems to go from bad to worse. Now a government panel has recommended that we test the vaccine on children, which raises a whole new array of ethical questions.

Don’t get me wrong: vaccines are the greatest boon to public health of the last 200 years. We eradicated smallpox, we’re close to eradicating polio, and childhood deaths from infectious diseases are far, far lower thanks to the vaccines we give our children. These are truly wondrous advances.

But the anthrax vaccine is different, from start to finish.

For starters, anthrax is not infectious. This might come as a surprise to those who’ve only heard about this through the media. An anthrax “outbreak” is impossible, because the B. anthracis bacterium cannot spread from person to person. Vaccines against diseases such as measles, mumps, and influenza protect millions of people each year, because these are common infectious diseases that spread easily between people.

Anthrax was never a public health threat, and it isn’t one now. We don’t need an anthrax vaccine. And by developing and then promoting one, the government is abusing the good will that the public has towards vaccines, possibly endangering the public health further by playing into the hands of the anti-vaccine movement.

The Centers for Disease Control (CDC) does not recommend that children be vaccinated against anthrax. In fact, it doesn’t recommend that anyone get routine vaccinations against anthrax:

“Vaccination is recommended only for those at high risk, such as workers in research laboratories that handle anthrax bacteria routinely.”

The CDC recommendation makes sense. Therefore I was stunned to learn this week that the National Biodefense Science Board (NBSB) recommended that we launch an anthrax vaccine testing program in children (see page 37 of their report).

The NBSB report admits that

“Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration.”

It also states that

“There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit.”

Case closed, right? We can’t conduct vaccine trials in children if there’s no benefit.

Somehow, though, even after these statements in their own report, the NBSB managed to recommend testing the vaccine in children. As justification, they present this claim:

“Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security.”

This is a massive overstatement. A national and global threat? Anthrax is not infectious, as the NBSB knows. The only people affected in an attack would be those directly exposed to the bacterium, likely only a handful of people. We don’t vaccinate millions of people just to protect a hypothetical few: this is an abuse of the public trust in vaccines.

So why are we wasting billions of dollars to develop, test, and administer a vaccine against something that hardly infects anyone? The anthrax vaccine development project was on its way to being cancelled by the U.S. before the 2001 anthrax attacks. In an ironic twist, the likely perpetrator of the attacks, Bruce Ivins, was allegedly motivated by his interest in reviving the anthrax vaccine program. If so, then he succeeded in a big way: in 2004, the government announced Project Bioshield, which dedicated $5.6 billion to biodefense, much of that going to anthrax vaccine research.

I’m not surprised that if the government dedicates billions of dollars to biodefense, and distributes it to companies and universities who then become dependent on these funds, then advisory panels such as the NBSB will recommend an ever-increasing number of security measures. After all, some of the members of that committee are funded by biodefense dollars, and if we cut the funding, their own livelihoods might suffer.

Speaking to the Washington Post, panel member Ruth Berkelman said:

“We need to know more about the safety and immunogenicity of the vaccine as we develop plans to use the vaccine on a large number of children in the event of a bioterrorist’s attack.”

No, we don’t. We don’t need to know about the safety of the vaccine in children because it would be unethical to test it on them. And if there is an attack, we shouldn’t respond by vaccinating “a large number of children,” because anthrax doesn’t spread from person to person. This is one vaccine we can do without.

[Note: I was a member of the research team that sequenced the DNA of the anthrax bacteria used in the 2001 attacks. We published our findings in two papers, one in 2002 and the second, after the investigation concluded, in 2011.]

Steven Salzberg Forbes Contributor. The opinions expressed are those of the writer.

I'm a Professor of Medicine and Biostatistics in the Institute of Genetic Medicine at Johns Hopkins University's School of Medicine. Until mid-2011 I was Professor and Director of the Center for Bioinformatics and Computational Biology at the University of Maryland, College Park. Before joining UMD, I was at The Institute for Genomic Research, where I sequenced the genomes of many bacteria, including those used in the 2001 anthrax attacks. At TIGR I was part of the Human Genome Project and the co-founder of the influenza virus sequencing project (which is when I first learned of the anti-vaccine movement). My research group develops software for DNA sequence analysis, and our (free) software is used by scientific laboratories around the globe. I did my B.A. and M.S. at Yale University, and my Ph.D. at Harvard University, and I have published over 200 scientific papers.

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Center for Infectious Disease Research and Policy (CIDRAP)

NBSB urges pre-attack studies of anthrax vaccine in kids

 

Lisa Schnirring  Staff Writer

Oct 28, 2011 (CIDRAP News) – An expert advisory panel today approved a recommendation that the US Department of Health and Human Services (HHS) develop a plan to study the use of anthrax vaccine in children before an attack with Bacillus anthracis.

A National Biodefense Science Board (NBSB) working group presented a draft of its final report to the full board today during a public teleconference. It weighed the pros and cons of gathering safety and immunogenicity data about the anthrax vaccine either before or after an attack.

The NBSB working group advises the federal government on biodefense countermeasure issues.

Before the vote, board members had the opportunity to voice their support or concerns. Ruth Berkelman, MD, director of the Center for Public Health Preparedness and Research at Emory University in Atlanta, said she agreed that data are needed before a bioterror event, but noted that the science arguments collide with ethical issues.

Though she said the working group was sensitive to ethical issues, she proposed that the group's recommendation be forwarded to an appropriate group for additional ethical consideration. The board tweaked its recommendation to include Berkelman's suggestion.

John Grabenstein, RPh, PhD, senior medical director for adult vaccines at Merck, said he has served on ethics review boards for about 20 years. "Kids are recognized as a vulnerable population, and there are special requirements to protect them," he said. "I'd rather know what the response is before the vaccine is offered to many, may kids."

The report's recommendations support the writing of a good protocol that would give parents a lot of information and plenty of time to consider all the aspects of a pre-event study, he added.

In April Dr. Nicole Lurie, Assistant Secretary for Preparedness and Response (ASPR) at HHS, asked the NBSB's anthrax working group to explore complex scientific, ethical, legal, and regulatory issues related to pediatric anthrax vaccination. The group held a public engagement meeting in July, and in September presented the report's executive summary to the full board and fielded comments from the public.

Anthrax vaccine adsorbed (AVA) has been used in about 2.5 million military members, so researchers are more familiar with the vaccine's safety and immunogenicity profiles in adults. Though US bioterror response plans say both adults and children should receive three doses of the vaccine with antibiotic prophylaxis after an anthrax attack, no studies have been conducted in children, which make up about a quarter of the US population.

During the public comment part of the meeting, members of the public strongly opposed the NBSB's recommendation, while others spoke in favor of it. Vera Sharav, with the Alliance for Human Research Protection, told the group that there is no evidence that anthrax is a threat that affects US children, and she accused the board of making the decision to protect vaccine company profit margins.

Meryl Nass, MD, an internist who has studied anthrax vaccine injuries and bioterror issues, said she believes the US public is almost unanimously against pursuing anthrax vaccine studies in children in advance of a bioterror attack. "But the people inside the beltway see things differently," she added.

However, Steve Krug, MD, a pediatrician and emergency physician in Chicago, said he took part in the NBSB's public engagement session in July. "The ethical issues are very pertinent, but I support the recommendations of this working group," he said.

The report and recommendation passed by a 12 to 1 vote. Patricia Quinlisk, MD, MPH, the board's chair, opposed sending the recommendation to HHS. "My background has influenced how I feel. I don't know if a pre-event option is the appropriate response," she said during the comment period before the vote. Quinlisk, a microbiologist and epidemiologist, is medical director for the Iowa Department of Public Health and has served on a host of vaccine safety and bioterror advisory groups.

After the vote, Lurie said she wanted to make sure the public knows that the NBSB is an advisory body and that its recommendations are not binding. She said the issue of studying the anthrax vaccine in children is very complex, and she predicted that dose-sparing studies being conducted in adults will have affect AVA issues related to children.

"We're not ready to make a decision at this time but will continue the dialogue," Lurie said.

See also:

October NBSB draft final report from anthrax vaccine working group

Sep 22 CIDRAP News story "HHS anthrax vaccine advisors weigh pediatric use