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.)