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“DoD
and the Anthrax Vaccine” Debacle
Recently
the Assistant Secretary of Defense for Health Affairs, Dr. William
Winkenwerder, addressed the troops through a written message on the www.anthrax.mil
website titled “DoD and the Anthrax Vaccine.” In the message Dr.
Winkenwerder described the “recent
controversy created by a U.S. District Court decision December 22 to
order a preliminary injunction against our anthrax program.”
What Dr. Winkenwerder failed to
explain to the troops was that a small group of DoD (Department of
Defense) officials responsible for defending the vaccination program
“created” the “controversy” by misrepresenting the legal,
medical and ethical aspects of the vaccine to commanders and soldiers,
as well as the citizens they serve. This directly resulted in violations
of US law due to an improperly approved vaccination program. An intellectually
honest analysis of past
misinformation and misrepresentations by those DoD officials will stop
the lawbreaking, ensuring legitimate, properly vetted, force protection
policies in the future. To do otherwise would be prejudicial to good
order and discipline, because the ethical lapses of the anthrax vaccine program will
undoubtedly bring discredit upon our armed forces.
Over the long run using a known inadequate vaccine for an experimental
use may not only prove illegal, but may also represent a facade
of force protection and an imprudent
doctrinal shift.
Specious vaccine, threat,
or both?
Early examples of DoD
misinformation included the assertion of “routine” vaccine use by
civilian veterinarians. Clearly untrue, US Army entities corrected
themselves in the Army Times on April 5, 1999, explaining they “did
not intend to mislead or confuse people.” Responsible DoD officials
systematically misled the remainder of the military about the anthrax vaccine timeline of events
in order to sell the program to the troops. When rhetoric didn’t work,
they spent taxpayer’s dollars on pens, coffee cups, mouse pads,
pocketknives, penlights, business cards, and other assorted marketing
paraphernalia labeled with the slogan, “Anthrax Kills, Vaccine
Protects.” Likewise, internal meeting minutes show that DoD officials
may have hyped the threat, insisting as early as 1995 the “need to
make the case that anthrax is currently the principal biological warfare
(BW) threat.” But the GAO (General Accounting Office) cautioned, “the nature and magnitude of the military threat of
biological warfare (BW) has not changed since 1990.”
DoD also acknowledged the need for
“changing the Food and Drug Administration License for … Anthrax
Vaccine to Meet Military Requirements” including an “amendment [/]
indication for protection against an aerosol challenge” i.e.,
(Inhalation). Bottom-line, some
DoD officials knew the vaccine was not properly licensed,
and misled the rest of the armed forces. Once professional
dissent surfaced military
officials denied the documented licensing problems, as well as the
personnel attrition costs due to the vaccine. Military officials were
later sanctioned for testimony before the Congress that “lacked the
necessary element of 'straightforwardness,' and so was inconsistent with
guidelines for honesty as set forth by the Joint Ethics Regulations (JER).”
Each time the anthrax vaccine
program misrepresentations were discovered the defenders altered the
sales pitch to explain or obscure the discrepancies. The vaccine once
deemed essential “body armor” later became a mere “additional
layer” of protection, since antibiotics were proven to be effective in
preventing the disease. Each of these examples pale in comparison to
other realities such as: the GAO warned “the long-term safety of the vaccine has not been
studied;” the vaccine was
known to be a likely cause of Gulf War Illness (GWI),
as well as recent pneumonia-like
illnesses;
the fact the vaccine license
was not finalized by the FDA until 2004,
and the fact it was illegally adulterated with unapproved manufacturing changes
by the manufacturer prior to the first Gulf War.
Crime doesn't pay, nor
does willfully blind negligence.
The latest discrepancy comes from
a federal judge. The judge found the vaccine license rule “has never been finalized.”
He added that the FDA (Food and Drug Administration) “failed to
provide any formal opinion vis a vis [the vaccine's] investigational
status,” and that “the Court would be remiss to conclude that the
original license included inhalation anthrax.” In legal terms the
judge found that “the DoD's administration of the inoculation without
consent of those vaccinated amounts to arbitrary action.” The judge
concluded that the vaccine is an “investigational drug and a drug
being used for an unapproved purpose. As a result of this status, the
DoD is in violation of 10
U.S.C. § 1107, Executive Order
13139, and DoD Directive 6200.2” Disappointingly, for years soldiers
were forced to resort to aggressively made this serious charge through the
media, and finally the
courts, since appeals within the chain of command were uniformly
ignored.
Without a doubt, the new 2004 FDA
ruling, completing the licensing paperwork, stands in clear contrast to
misinformation soldiers have been told for years, beginning with the
Army Surgeon General, about “the
fully FDA approved anthrax vaccine.”
Most egregious of all is the fact that these same DoD officials
testified falsely to the Congress about the investigational status of
the vaccine, and the Department of Defense Inspector General dismissed
complaints about these testimonies while allowing Office of the
Secretary of Defense officials running the anthrax vaccine program to
investigate. Equally disturbing, in defending the anthrax vaccine from inquiries
by the states and the
federal legislature a stark divergence and reversal of scientific opinion
emerged to protect policy
over the troop’s legally prescribed health rights.
Using empty
rhetoric about helmets and flak jackets,
DoD officials failed to adequately defend the anthrax vaccine program.
Top DoD medical officials also ignored warnings. For example, Dr.
Winkenwerder was personally briefed at the Pentagon and cautioned by
officers about the precise illegalities of illegal mandatory
experimental use of the vaccine in January 2002. Though he told
reporters at a Pentagon press briefing the federal judge's decision “came
as quite a surprise,” Dr.
Winkenwerder had previously dismissed his military officer's cautions,
creating the recent legal impasse. When asked if the judge was
“wrong,” Dr. Winkenwerder replied, “Absolutely.” More
appropriately, in his note to the troops, the doctor dutifully
explained, “In response to that court order, DoD stopped giving
anthrax vaccinations to service members until the legal situation was
clarified.”
You want data? You want
approvals? No problem.
Dr. Winkenwerder also maintained
that on “December
30, 2003, FDA issued a Final Rule that had been under
development for more than one year.” More accurately, the work on this
rule began as a result of an FDA Citizen
Petition filed in October
2001, and endorsed by hundreds of concerned soldiers, based on the
discovery that the FDA never completed the anthrax vaccine licensing
process. FDA responded
to this petition, as
required by law, saying they “agree that the Food and Drug
Administration (FDA or the agency) should complete the Biologics Review
for anthrax vaccine by issuing a final rule.”
Dr. Winkenwerder elaborated that
FDA, a codefendant with the DoD in the anthrax vaccine lawsuit, issued a
new license rule that made “explicitly clear the finding that anthrax
vaccine prevents all forms of anthrax, including inhalational
disease.” While true that the FDA did make a suspect overdue ruling
with this indefensible assertion, there is more to the story. In fact,
FDA’s final rule contradicts the findings of the original FDA expert
panel's proposed rule on the anthrax vaccine. The original review panel
maintained, “The vaccine manufactured by the Michigan Department of
Public Health has not been employed in a controlled field trial,” and
that “inhalation anthrax occurred too infrequently to assess the
protective effect of vaccine against this form of the disease.”
FDA discarded the original,
inconvenient, expert findings, and justified a new assessment of
efficacy by adding animal data to the administrative record. This animal
data was generated by DoD and added to the anthrax vaccine license rule,
but without following the strict guidelines Congress wrote into law.
This follows a pattern
of DoD failing to follow normal processes
with belated generation of postfix science in order to protect the
anthrax vaccine program instead of admitting errors. DoD’s long held
assertion of the anthrax vaccine's full FDA approval is unmistakably
contradicted by the very requirement of the final rule. Originally, DoD
officials responsible for the anthrax vaccine referred to the lack of a
final rule as a “bureaucratic loose end ... which apparently has no
regulatory meaning.”
DoD officials were plainly wrong
about the significance of the final rule, as they were about the illegal
and adulterating manufacturing changes made to the vaccine prior to the
first Gulf War as documented by the GAO.
Similar to the pattern of cooperation between FDA and DoD exhibited by
the recent final ruling, FDA also approved these illegal alterations
over ten years after the fact. Suspiciously, FDA's regulations normally
require such major modifications to be approved 30 days prior to
implementation, and only after proper testing to ensure no negative
impacts on a vaccine's purity, potency, sterility and stability.
Obviously this did not happen, and the GAO subsequently reported a one
hundred fold increase in potency (protective antigen levels) of the
vaccine. Instead of studying these illegal manufacturing changes, and
their relationships to Gulf War Illness, pseudo-scientific reports were
apparently launched as decoys in order to distract and confuse, while
officials inaccurately emphasized the “uniformly
fatal nature” of the
disease.
Threat or theatrics?
Instead
of properly approving the anthrax vaccine program
Secretary of Defense Cohen hoisted a 5-pound bag of sugar on national TV
in 1997 to simulate the anthrax “threat.” True to form, Dr.
Winkenwerder shielded criticism six years later by holding up a DoD funded report
from the Institute of Medicine (IOM) during a press conference. The
report congratulated the assistance of DoD officials, and cited animal
data as proof of the vaccine's effectiveness against inhalation anthrax.
Unfortunately, such reports and evidence hold no regulatory authority
unless properly utilized. Tucked away in the IOM report's final
appendix, were previous critical reviews of the vaccine two years
earlier by the same Institute
of Medicine, which
admitted: “There is a paucity of published peer-reviewed literature on
the safety of the anthrax vaccine.” In
other words, once again, postfix pseudo-science was invented,
manipulated and funded by the DoD in the interim two years to create the
appearance of propriety. Independent critiques of the report confirmed,
“Institute
of Medicine ignored evidence of several recent research studies from
three different nations that have implicated vaccines, often including
anthrax vaccine, in the epidemiology of Gulf War illnesses.”
As further illustration of
manipulating the known “paucity” of data behind anthrax vaccine
efficacy, Dr. Winkenwerder also told soldiers about an old study of a
different vaccine, but “similar” vaccine, where “no one who
received the vaccine series got inhalational anthrax, but five people
who did not receive the vaccine series did get this deadly disease.”
What he didn't tell the troops is that the lack of a disease, or a
“paucity” of data, doesn't prove anything according to the
regulatory requirements of the Food, Drug and Cosmetic Act due to the a
myriad of variables that might prevent a specific disease. But, of
course, it is a snappy sound bite, part of the modus operandi of
“making the case” and selling the anthrax vaccine program.
DoD leaders sponsor
changes to the laws they violated.
Dr. Winkenwerder also claimed that
experiments with monkeys exposed to inhaled anthrax justified use of the
vaccine. What the doctor didn't tell the troops is that this monkey data
was not allowed under the law for full licensure of vaccines or drugs
until June 2002 when DoD successfully sponsored changes to the very laws
that the federal judge maintains were being broken. DoD officials had
previously written to the Congress admitting, “DoD
does not have a current approved mechanism for licensure of chemical and
biological defense medical products (i.e., drugs and vaccines)
because legal and ethical constraints prevent adequate full testing in
humans.” This is why the
anthrax vaccine was experimental.
DoD further explained that the
“solution” was “to allow animal efficacy data to be used in lieu
of large-scale human clinical efficacy trials. This mechanism of
licensure is vital to provide military service personnel with licensed
products.” But, once again, following the pattern of improper
approvals when it comes to the anthrax vaccine, the animal data was
inserted after the fact into the FDA's final rule without following the
law. A recent Air Force Times article titled, “Judge
temporarily lifts order”
accurately captured the anomaly in the regulatory process with a quote
by Peter Meyers, a Georgetown University law professor. He explained to
the Times that the ‘rule could be challenged because new data were
placed in the record after 1985 without allowing for public comment.’
He added that “It's
just so contrary to typical administrative procedures,”
and “This is not the right way to do it.”
Ruse continued by a misled
ex-insurance company doctor.
Dr. Winkenwerder
inherited the mistakes of those preceding him. He accurately informed
soldiers that “DoD is proceeding with anthrax vaccinations,” but
that “litigation is continuing,” and that “additional legal
proceedings will be required to bring final resolution to the matter.”
While it is true that the “Court lifted the preliminary injunction”
on the entire military, the injunction remains in effect for the
plaintiffs in the case. In the judge's new order
he specifically clarified “that the government is entitled to a stay
of the Court's injunction pending further order of the Court and further
challenges to the government's final rule.” The judge wrote that the
timing of the FDA issuance of the rule is “arguably highly
suspicious” and the Air Force Times article accurately described the
ongoing nature of the legal controversy.
On January 14, 2004, the judge
promptly ordered FDA to produce the “administrative record”
supporting their new ruling on anthrax vaccine. He also outlined the
timetable for the challenge of the “validity of the FDA Order,” as
well as arguments addressing whether the court can “grant systemic,
nationwide relief” in the absence of class certification. Soon
thereafter, the DoD began dropping charges against soldiers facing
court-martial over anthrax vaccine refusal. The DoD also began to
quietly deploy soldiers in the high threat area without the anthrax
vaccine’s “additional layer of protection.” Contrary to the
bravado of the FDA’s “highly suspicious” final rule, and the moral
imperative about being Duty-Bound
to Order Anthrax Shots, DoD
quietly, prudently stemmed the damage, but again, without admitting
fault.
Dr. Winkenwerder, purportedly
based on the ill-conceived guidance of those responsible for the
miscalculations inherent in the AVIP, concluded his message to our
troops with the hope that the legal conundrum will be clarified soon,
and that “inflammatory and inaccurate statements the litigation has
spawned can be clearly put to rest.” The soldiers dutifully opposed to
the illegalities of the program concur. If the inaccurate statements do
continue our DoD risks the very real possibility that the anthrax
vaccine debacle will surpass the tragic mistakes documented in the
cover-up of radiation testing and Agent Orange exposures. Regardless of
the ongoing legal proceedings, it would lack moral courage for the DoD
to not correct
the wrongdoing associated with the anthrax vaccine
prior to the judge's declaration about the illegality of the anthrax
vaccine program and the FDA's final rule on the vaccine's license.
Gulf War Illness Cover-up.
Correcting the documented
wrongdoing is particularly imperative as evidence continues to mount over
a “significant
association between anthrax vaccination, medication and health problems
of Gulf War Veterans,” and the fact that the anthrax
vaccine is linked to pneumonia-like illnesses. Also, according to
the GAO, “systemic reaction rate reported through the survey
represents a level more than a hundred times higher than the 0.2 percent
published in the product insert.”
Worse yet, the FDA
product insert also
increased the birth defect risk of anthrax vaccination to Category D,
meaning a “demonstrated
risk to the fetus,” based on a US
Navy study. As well, suspect deaths and dozens of illnesses resembling
those listed on the Gulf War Illness registry appeared in the fine
print. The malfeasance documented in these revelations distinguishes the
anthrax vaccine from previous missteps in military medicine. The
difference this time is that DoD officials have been caught real time in
their illegal conduct and willful attempts to cover-up experiments on
our troops. Unless fundamental transforming
accountability is sought
through an investigation of the past illegal conduct, false testimonies
and criminal medical negligence, our nation will guarantee that the
historic pattern of illegal experimentation on US soldiers will
continue.
As the federal judge maintained,
“The Court is persuaded that the right to bodily integrity and the
importance of complying with legal requirements, even in the face of
requirements that may potentially be inconvenient or burdensome, are
among the highest public policy concerns one could articulate. ...The
women and men of our armed forces put their lives on the line every day
to preserve and safeguard the freedoms that all Americans cherish and
enjoy.” Without a doubt, American soldiers need government officials
providing proper oversight to ensure the protection of their rights,
which were formulated due to prior abuses. As Mr. Stephen Hadley, the
Deputy National Security Advisor for President Bush, articulated, “The
vaccination program is a very serious issue. Maintaining the trust and
confidence of our men and women in uniform is critical to the future of
our armed forces.”
Time will tell if words equate to action.
The duality of the
professional military ethic.
Soldiers worldwide are asking
ethical questions regarding the anthrax vaccine dilemma. Are DoD leaders
conducting themselves in an ethical manner within the complex landscape
of the anthrax vaccine program? Do DoD leaders mandate ethics simply to
look ethical? Do our DoD leaders hold themselves to the same standard of
zero tolerance by which they hold our troops? When it comes to the
anthrax vaccine program classical ethics appears to have been replaced
by a utilitarian view where laws were broken in order to protect policy
decisions. The vaccine itself created an appearance of force protection,
though some in the department knew of the vaccines limited utility. Some
knew laws were being broken. DoD officials sponsored changes to the laws
being violated. DoD officials misled our lawmakers about the
lawbreaking. DoD officials testified against, and allowed the punishment
of, their fellows in the profession of arms. DoD officials exacerbated
the breakdown, creating after the fact science, further misleading the
nation. All the while, soldiers were punished for questioning the
lawfulness of the proven illegal mandate of an experimental vaccine with
a license FDA failed to finalize for 32 years.
Undoubtedly, this military medical
dilemma will not end until the law is followed and the wrongs are
righted. The federal courts declared the mandate illegal absent a final
license ruling. One house of the federal legislature, via Senate
Resolution 278, also
questioned the investigational use of the vaccine and prudently asked
the Secretary of Defense and Board for
Correction of Military Records to “reconsider adverse actions already
taken or intended to be taken against servicemembers for refusing to
accept the anthrax or smallpox vaccine.” The other house reiterated
the call for prudence with Congressional National Security
Subcommittee Chairman Christopher Shays suggesting that our DoD leaders
make “amends
and restore in good standing those that have been punished.” These salient calls are commonsense for a nation and its military
members trained to critically analyze and challenge a “patently illegal order.”
The anthrax vaccine mandate was patently illegal because the officials
responsible for the vaccine and the mandate either knew it violated US
law, or were derelict in their duty for failing to know the law and
implement the program legally with informed consent or a Presidential
waiver.
Conclusion.
With
the violations of law now black and white, and the two thirds of the US
government confirming the illegality of the mandate, our leaders would
be derelict in their duty to not exonerate the soldiers previously
dishonorable discharged and imprisoned, without due process, and in the
name of good order and discipline. Our leaders must exhibit the “moral courage”
to admit documented institutional wrongdoing. To do otherwise will leave
America’s soldiers questioning whether DoD leaders are driven by the
same professional military ethic they expect the remainder of our armed
forces to uphold.
By Lt. Col. Russell E. Dingle, USAF Reserves, retired; and Maj.
Thomas L. Rempfer
[Disclaimer: The conclusions and
opinions expressed in this document are those of the author cultivated
in the interest of academic freedom of expression, and do not reflect
the official position of the U.S. Government, Department of Defense, or
the U.S. Air Force.]
(More
information exposing the illegality of the anthrax vaccine program is
available at: http://www.milvacs.org/tiger.cfm.
The DoD’s anthrax vaccine website is available at: http://www.anthrax.mil.
The key to understanding the anthrax vaccine program is education
through a thorough understanding of the timeline of events, as well as
the documented historic modus operandi of the military medicine, which
requires similarly historic transformation.)
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