Regarding Testing Anthrax Vaccine in Children

Below is my recent letter to the Chair of the Presidential Commission for the Study of Bioethical Issues, preceding the Commission’s meeting last week.  The Commission’s blog mentions some of what was discussed.  The Commission will report its views to the DHHS Secretary by year’s end.

Meryl Nass, MD
Board Certified in Internal Medicine
Mount Desert Island Hospital
10 Wayman Lane
Bar Harbor, Maine 04609
(207) 288-5119
July 28, 2012
Dr. Amy Gutmann
President, University of
Pennsylvania
1 College Hall, Room 100
Philadelphia, PA 19104-6380
Dear Dr. Gutmann,
I sent a letter regarding
anthrax vaccine to the Presidential Commission for the Study of Bioethical
Issues in late January 2012 (copy enclosed).  Because Commission staff did not confirm whether my letter
was shared with the Commission members, I am writing you directly. 
With respect to anthrax
vaccine and its use as a countermeasure in children, I believe my original
letter provided considerable detail. 
I would just like to emphasize that the vaccine’s efficacy in humans for
inhalation anthrax is unknown.  The
efficacy of several anthrax vaccines in clinical trials has depended on the
species and strain of animal infected, the strain of anthrax used, and the
magnitude of the exposure.  In many
animal studies, high antibody levels have failed to protect the animals and
prevent deaths.
I am enclosing the consent
form for testing anthrax vaccine in children developed by CDC and FDA in 2001,
after the anthrax letters. It said, “Anthrax vaccine has not been shown
to prevent infection when given to people after exposure to anthrax spores
,” and “You should not consider the vaccine as
treatment for anthrax. The vaccine as given in this program has not been shown
to give long term protection against anthrax.
After holding 5 hearings on
the subject of anthrax vaccine in 1999, the House Committee on Government
Reform issued a report titled Unproven Force Protection.[i]  Two of its findings were:
  • Safety of the vaccine is not being monitored
    adequately. The program is predisposed to ignore or understate potential
    safety problems due to reliance on a passive adverse event surveillance
    system and DOD institutional resistance to associating health effects with
    the vaccine.
  • Efficacy of the vaccine against biological
    warfare is uncertain. The vaccine was approved for protection against
    cutaneous (under the skin) infection in an occupational setting, not for
    use as mass protection against weaponized, aerosolized anthrax.
     
Today’s vaccine is the same
as that used in 1999 and 2001.  But
why use the vaccine anyway?  The
immediate medical response to an exposure includes antibiotics and passive
immunization with one of several available antibody products, when needed.
There has been concern about
late germination of spores, which may remain resident in the lungs for several
months.  This concern has led to
the recommendation to vaccinate, in addition to providing immediate
therapy.  Yet early germination and
infection by spores should induce a protective immune response to later spore
germination.[ii]  Late germination associated with immune
failure can happen, but 
seems to be a rare
event.
  Of the 30,000 people
offered antibiotics after the anthrax letters, fewer than half completed the
prescribed 60 day course, and none developed a late case of anthrax.
I was struck by errors in the
presentation of Major General John Parker, M.D. (retired
) in May, and by the fact there were no anthrax
experts in the room who could answer technical questions germane to the
discussion.  It looks like that
omission will continue at the August meeting (based on the list of panelists),
despite concerns expressed by you at the last meeting regarding the need for
clarification of facts regarding anthrax vaccine science. 
General Parker deflected your
question of whether those who were familiar with the vaccine, and urged its
use, would vaccinate their own children. 
He answered that some military members wanted their children to receive
the same vaccine protection they had. 
Yet if those soldiers were informed the vaccine had not proven
protective in humans, would they still want their children vaccinated?  And what of the researchers and
government administrators who spoke in favor of a trial in children?  Will they offer their children or
grandchildren for testing?
It is difficult to convey the
degree of effort expended over many years to promote anthrax immunization,
which has created a smokescreen around anthrax vaccine science.  For those unfamiliar with the details,
it appears unbelievable.  I can
best convey it by using a metaphor: 
the BioWatch program.
Pulitzer prize-winning
journalist David Willman wrote a recent article on the failures of BioWatch, a
federal program employing sensors to identify the offensive use of
microorganisms, in Philadelphia and other large cities: 
No matter how much evidence
Willman unearthed about the program, official spokespersons kept repeating
their mantra about BioWatch’s effectiveness.  Willman’s article shows how the system works to protect
favored programs in Washington, regardless of their value. The amount of money
involved is phenomenal.  The
anthrax vaccine manufacturer has received over 2 billion dollars for anthrax
vaccine, after buying the factory for 18 million dollars from the state of
Michigan in 1998.
It appears that the focus of
the August meeting of the Commission will be on countermeasures in general,
rather than anthrax vaccine in particular. Public comments on the ethical implications of pediatric countermeasures research have been solicited.
I’d like to say several
things about this.  First, unlike
most therapeutic agents, anthrax vaccine has pressing safety and efficacy
questions.  Anthrax vaccine should
therefore be considered individually by the Commission, with its unique issues
in mind, rather than as one of many possible countermeasures.
Next, many countermeasures
designed to respond to biological, chemical and radiological agents have been
given a manufacturer waiver of liability through the Public Readiness and
Emergency Preparedness (PREP) Act. 
The result is that they may
not have been developed or tested with the same rigor as other medical
products. Yet reliable testing in adults for efficacy and safety should precede
testing of such products in children, if at all possible.  Thus the decision to test
countermeasures that have liability waivers, including anthrax vaccine, in
children
, should require a higher
level of evidence derived from adults, compared with testing products not given
a liability waiver.
 
Finally, the press release
for this meeting stated, “The Commission is examining whether the U.S.
government should do research that could cause harm to protect children from
high consequence events 
with a low or unknown
likelihood of happening.
”  The low/unknown likelihood of such an
event would suggest such research cannot meet the requirement of 45 CFR 46.407
for approvable pediatric
research:  which is to present “a reasonable
opportunity to further the … alleviation of a serious problem affecting the
health and welfare of children.”
Some panelists at the May
Commission meeting alluded to the need to balance risk and benefit as a
justification to perform pediatric countermeasures research.  45 CFR 46.407 does not call for
balancing benefits and risks. 
Instead, it provides a nonporous barrier against potential child subject
endangerment, designed with child protection as the sole consideration,
regardless of any potential benefits for children or society that may be
invoked.
Thank you very much for
taking the time to serve as Chair of the Commission, and for taking these
concerns into consideration.
Sincerely yours,
Meryl Nass, M.D.
Cc:  Presidential Commission for the Study of Bioethical Issues

[ii] Weiss S,
Kobiler D, Levy Haim et al. Antibiotics Cure Anthrax in Animal Models.
Antimicrobial Agents and Chemotherapy 2011; 55(4): 1533-42.
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