Ethical Issues Related to Testing Anthrax Vaccine on Children
April 02, 2013
Story at-a-glance
The US government has proposed the need for a trial in
children of anthrax vaccine, framing it as a necessary step
in protecting them from the effects of a potential future
bioterrorism attack using weaponized anthrax
The Alliance for Human Research Protection (AHRP) is in
strong opposition to the trial and has submitted an exposé
to Amy Gutman, PhD, Chair of the Presidential Commission for
the Study of Bioethical Issues
Experimenting on the most vulnerable members of our society
with a dangerous vaccine without the promise of any benefit
to them is heartless, unethical and unnecessary, not to
mention violates a number of federal regulations protecting
children
The entire premise that we are at high risk for a
bioterrorist attack is erroneous, and the idea that a
vaccine is needed is ludicrous when antibiotics have proven
100 percent effective for anthrax exposure
The AHRP suggests the government’s motivation for this
vaccine trial may be a backdoor effort to capitalize on the
public’s post-9/11 fear with the goal of expanding civilian
vaccinations and increasing vaccine profits by any means
possible, while turning a blind eye to the well-known risks
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The US government has proposed a children’s trial of anthrax
vaccine arguing that it is a necessary step in protecting them
from the effects of a potential future bioterrorism attack using
weaponized anthrax.
The Alliance for Human Research Protection (AHRP) is in
strong opposition to this idea, and rightly so. Experimenting on
the most vulnerable members of our society with a dangerous
vaccine, without the promise of any benefit, is both heartless
and unnecessary — not to mention highly unethical.
The fact that anthrax is a dangerous bacterium deserving our
concern if it is weaponized is not the issue. Unlike most other
bacteria, anthrax forms very potent spores that can remain alive
under harsh conditions for 100 years or longer.
The rugged survivability of the anthrax spore is what could
make it a powerful biological weapon. For example, it can easily
survive being dropped from an airplane or exploded in a bomb.
The issue is that your risk for anthrax exposure has been
vastly blown out of proportion. History tells us that exposure
to anthrax is extremely rare, and bioterrorism experts say the
likelihood of it ever being used as an agent of attack on a mass
scale is negligible.
Fortunately, the idea of trying out the anthrax vaccine on
children has met with fierce opposition. In fact, even
Paul Offit, a pediatric vaccine developer and long-time
vaccine advocate, advised against such a trial.1
On February 18, 2013, AHRP sent a detailed exposé to Amy
Gutman, PhD, Chair of the Presidential Commission for the Study
of Bioethical Issues, which is the committee assigned the task
(by DHHS Secretary Sebelius) of evaluating the ethical problems
with the proposed vaccine trial.
The Commission met four times over the past year regarding
this issue, having completed their deliberations in January
2013. You can read the complete transcript of their final
discussion here.2
This powerful exposé, authored by Vera Sharav and
Dr. Meryl Nass of AHRP, is a convincing argument that
exposes the many flaws in logic, misleading propaganda, and
ethics violations of this proposed vaccine trial. What follows
is a synopsis of the concerns covered in their exposé.
Anthrax as a Bioterrorism Agent is Extremely Unlikely
In modern times, no foreign enemy has used biological weapons
against Americans, neither military nor civilian.
The only possible exception was the anthrax-laced mail attack
in October 2001. The federal government has maintained that a
scientist in charge of anthrax vaccine testing at a US military
lab, who is now dead, was to blame for the anthrax letter
attacks although others have suggested the mystery is not solved
and the investigation should continue.3
Since 2001, there have been no credible reports about an anthrax
bioterrorism threat to the U.S. civilian population.
How can they declare an emergency when there is no
evidence for one?
In the anthrax-laced mail attack of 2001, thousands of people
were exposed to anthrax spores. Antibiotics were successful in
preventing illness in 100 percent of those treated
after exposure. Five people died, but their cases were
recognized very late. There was no additional benefit from using
anthrax vaccine over antibiotics alone and the vaccine was
accepted by less than two percent of those who received
antibiotics.
This is a
Flash-based video and may not be viewable on mobile devices.
Why Do We Need the Anthrax Vaccine when Antibiotics have Proven
100 Percent Effective?
The anthrax vaccine, BioThrax,4
manufactured by Emergent BioSolutions, has never been proven
effective in humans against inhaled anthrax and is not licensed
for post-exposure use, even in adults. Two papers published in
2012 by top anthrax scientists (Ingram and Baillie, and
Bellanti, et al) confirm this point. Because there is no animal
model for anthrax vaccine response that translates to humans,
there is no human efficacy data for adults or children;
therefore, it’s impossible to derive effectiveness data for
children from any anthrax trial that DHHS may propose.
That said, why would a vaccine be needed when there is
already a treatment proven to be 100 percent effective? As
stated above, prompt treatment with antibiotics after anthrax
exposure was 100 percent effective for all 30,000 people exposed
in 2001. When the appropriate treatment is antibiotics, why the
urgency to test an outmoded, inferior and potentially dangerous
treatment on children, especially when the vaccine itself
frequently causes severe adverse reactions?
Giving a Risky Vaccine to Children Violates Federal Regulations
The statistics for adverse reactions from anthrax vaccine are
very concerning:
According to the 2002 anthrax vaccine label, between
five and 35 percent of vaccine recipients develop systemic
adverse reactions.
Of those, approximately six percent are serious and life
threatening, including birth defects, hospitalization,
permanent disability and death.
According to the Government Accountability Office (GAO),
one to two percent of vaccinated individuals may experience
severe adverse reactions harmful enough to result in death
or disability.
There is no acceptable justification for exposing healthy
children to these dangers. In fact, doing so is a violation of a
US statute requiring children to be exposed to no greater than a
“minor increase over minimal risk.” The child subjects of the
proposed vaccine trial are not receiving treatment for any
condition or other problem affecting their health or welfare
(“nontherapeutic research”), so do not stand to benefit in any
way, which is against Federal regulations.
In fact, the Presidential Commission was never informed of a
pivotal trial involving the safety issues with anthrax vaccine.
The complete findings of this trial were submitted to the FDA in
2009 but have never been published or disclosed to the public.
The trial found that 186 people suffered 229 serious adverse
events during the trial, with seven deaths. That is, 12 percent
of the subjects suffered serious adverse events! Department of
Health and Human Services (DHHS) Secretary Sebelius has the
authority to demand the release of this safety data at any time,
but she has not done so.
If the proposed trial were going to provide meaningful
answers to any questions about the vaccine’s safety for
children, thousands of children would have to be
experimented upon. The proposed trial, which involves a much
smaller number of children, would have no scientific or clinical
value at all and would therefore be unethical and illegal under
US statute.
Whose children will be the sacrificial lambs in a
corporate-government collusion scheme to expand the BioThrax
stockpile and create a potential civilian market for the
vaccine’s sole US manufacturer, Emergent BioSolutions? And what
happens when something goes wrong? Who is liable?
Government Shields Vaccine Makers from All Liability
If you're in the military, you can't sue the government for
damages for injuries that occurs during your military service
(Fere's Doctrine). Instead, you have to use the VA health
system. The situation is just as dire for civilians when it
comes to pandemic vaccines, such as the now infamous H1N1
swine flu vaccine, as well as anthrax, thanks to the PREP
Act passed by Congress and signed into law in 2006.
The
PREP Act, or Public Readiness Emergency Preparedness Act,
said that if a public health emergency is declared by the
federal government, the manufacturer of a product made to
address the emergency would be given a near
blanket waiver of liability. This waiver of liability would
apply to the vaccine manufacturer, the doctors administering the
vaccine, the distributors, and anybody in the government who had
been part of the planning for a vaccine or drug program. The
waiver was supposed to be for “emergencies” only.
In spite of the lack of any credible anthrax threat, DHHS
Secretary at that time, Michael Leavitt, invoked the
extraordinary “emergency” powers given to him by Congress and
declared anthrax a public health emergency in 2008, effective
through 2015. So, when the government declares anthrax a “public
health emergency,” you are prevented from seeking damages if you
(or your child) are injured by the anthrax vaccine. And your
risk of being injured by this vaccine, based on its history, is
quite likely.
Problem-Reaction-Solution... Will You Take the Bait?
There is a strategy that some refer to as
“Problem-Reaction-Solution,” which looks like this:
You create or manufacture a problem
There is a public reaction
You solve the problem in a way that completes your own
agenda
The threat of bioweapons can easily be manipulated for
financial gain using the Problem-Reaction-Solution process. With
respect to the anthrax vaccine, the problem created after 9-11
was the fear of bioterrorism attacks on the U.S. civilian
population. People reacted to the implied threat of further
attacks with widespread panic, and the government and
pharmaceutical industry came to the rescue with plans to expand
production and civilian stockpiling of anthrax vaccine already
being given to U.S. military personnel.
The bizarre anthrax letters incident 10 years ago boosted the
biodefense budget by $60 billion dollars, and Emergent
BioSolutions, the sole producer of BioThrax vaccine for the US
military, received a $1.4 billion contract to produce anthrax
vaccine for public use. This contract was recently renewed to
the tune of $1.25 billion.
The PREP Act in combination with the
Problem-Reaction-Solution process creates a massive opportunity
for vaccine makers by allowing them to "sneak in" new
ingredients and adjuvants (immune-boosting additives with
potentially unknown or risky profiles) under the guise of
needing to prepare for a bioterrorism “emergency.” Then, since
the new vaccine ingredient has been used already, they can use
these ingredients in other vaccines without having to
go through a rigorous approval process.
By declaring a public health emergency, Secretary Leavitt did
not protect the public health but instead sacrificed the
public’s civil and human rights, while protecting biodefense
stakeholders. The Presidential Commission’s review process
itself was extremely flawed, and there were multiple conflicts
of interest. AHRP identified the following issues:
No expert witnesses knew anything about anthrax or
anthrax vaccine and there was no scientific testimony about
the vaccine's safety or efficacy in adults. They never even
looked at the vaccine label!
No details about the proposed vaccine trial were
provided, and the issue of anthrax risk was never discussed.
The trial on children is ostensibly to test the vaccine
for post-exposure use in an emergency, but in fact
the trial would involve pre-exposure, which might
lay the groundwork for the vaccine’s routine use in children
The Commission was never briefed on the existing legal
cases relevant to pediatric research that provides them no
benefit
The Real Motivation: Increasing Vaccine Profits by Any Means
Possible
The entire history of the anthrax vaccine enterprise has been
rife with evidence of profiteering at taxpayer expense. To gain
insight about the motives behind DHHS’ anthrax policies, you
need to examine the hidden web of financial conflicts of
interest and revolving doors.. The government was able to
capitalize on the public’s post-9/11 fear of another terrorist
attack by getting away with pretty much anything. The country
was manipulated into believing it “needed” a 2 billion dollar
stockpile of anthrax vaccine, which DHHS continues to maintain
in spite of safety concerns about the vaccine and lack of
efficacy data. Indeed, the anthrax vaccine has been exceedingly
profitable to BioThrax manufacturer Emergent BioSolutions:
On October 3, 2011, the government awarded Emergent
BioSolutions a five year contract worth up to $1.25 billion
to provide millions of doses of anthrax vaccine for
government stockpiles
Emergent BioSolutions has sold more than 55 million
vaccine doses to the US government and plans to supply
another 44.75 million doses over the next few years5
Emergent BioSolutions has made more than one billion
dollars in profit6
Realizing that experimenting with children is fraught with
difficulty in terms of informed consent and ethical
restrictions, they cleverly devised a method for conducting the
trial that would sidestep these problems by starting with 18 to
20 year olds, who CAN give informed consent, then working their
way down through the age groups. This "method" has an underlying
assumption: that data do not exist on this vaccine's safety, and
must therefore be obtained for 18 to 20 year olds. Of course,
that is hardly the case. According to AHRP, such a trial could
begin to overturn existing federal protections for child
subjects.
Once you consider the issue in its broader context, you can
only conclude that the real goal of this child trial is
expanding civilian vaccinations and marketing the vaccine to
parents, rather than obtaining safety and efficacy data.
Naturally, the financial incentives are enormous for
increasing vaccine stockpiles and widening its use.
In Summary
The government’s proposed anthrax vaccine trial for children
is being vehemently opposed by AHRP, citing conflicts of
interest, corrupt political motives and financial incentives,
and a blatant disregard for federal regulations that protect
children from unnecessary harm. The entire premise that we are
at high risk for a bioterrorist attack is erroneous, and the
idea that a vaccine is needed is ridiculous, as antibiotics have
proven to be 100 percent effective for anthrax exposure. This is
yet another example of greed and political corruption trumping
public health.