The Parallel Universe of Professional Military Ethics ...

...and the Defense Department's Anthrax Vaccine Immunization Policy

By Major Thomas L. Rempfer and Major Russell E. Dingle

Have you ever thought you might be a visitor to a parallel universe where everything you've been taught is upside down? Or imagine being a child, and one day realizing your parents were telling you to lie, steal and cheat in school. Confused you ask, "But I'm not supposed to do these things." Shocked at your insubordination, they threaten you with a permanent "time out" if you do not comply with their will.

FACT: 1969 -- The Public Health Service deems that the only data ever supplied for approval of the current anthrax vaccine was not scientifically significant, and "can hardly be accepted as scientific evidence for efficacy of the vaccine." (1)

Just as children are taught to do the right thing, so too are military members serving the United States similarly trained to know right from wrong. But professional military ethics goes much further. Military Officers, entrusted with the responsibility to support and defend the Constitution, have been trained to root out illegalities, and to keep the armed forces honest and worthy of the nation they defend. Having learned lessons from history, such as the Nuremberg precedents of World War II, officers in America's armed forces are trained from day one to challenge illegal or immoral orders.

FACT: 1985 -- The Federal Register acknowledges that data used for the current anthrax vaccine approval was from different vaccine. (2)

Defense Department submits a Request for Proposal for a new anthrax vaccine that is safe and effective. (3)

So what happens when the child or the American soldier enters a precarious parallel universe where the codes, edicts, values and oaths they've pledged to uphold become meaningless, at least when applied to one particular issue? Such a perverse parallel universe exists in and around the militaries' Anthrax Vaccine Immunization Program (AVIP). Most wearing the uniform know something is very troubling and wrong.

FACT: 1989 -- The Defense Department acknowledge the unsatisfactory nature of the anthrax vaccine in testimony to the Senate Government Affairs Committee (with Sen. Cohen in attendance) (4)

Military doctors acknowledge their anthrax vaccine should be considered "experimental," and Army doctor Col. Art Friedlander acknowledges that AVA is "unsatisfactory." (5)

We unknowingly entered this parallel universe in September of 1998 as members of the Connecticut National Guard when our Commander officially tasked us to develop questions for higher headquarters to detail the uneasiness of the troops concerning the anthrax vaccine. We were not alone. Servicemembers from around the world were asking their Commanders, "Why would we take a vaccine originating from a manufacturer that is cited by the Food and Drug Administration (FDA), and is closed down due to those deviations?" The answers from Commanders were confusing: "It's okay, just take the shot because it's not worth giving up your career over." Or, "There are no answers to your questions." Or most disturbing, "Comply and keep quiet, or we'll make sure you never work in the military again."

Amazingly, the anthrax vaccine plant remains shut down and non-validated to this day while the program has stagnated to a virtual halt, or a "temporary slowdown" as the political affairs officers would portray.

FACT: 1994 -- A US Senate report deems the militaries' use of the anthrax vaccine in the Gulf War as "investigational" -- therefore requiring prior consent according to law -- Senate Report 103-97 (6)

We found members of Congress, the General Accounting Office (GAO), and even members of the media on the same journey of unanswered questions and Defense Department stonewalling. The discoveries were compelling -- a vaccine developed for and by the US Army, and the manufacturer's assets, patent, and licenses ostensibly owned by the Defense Department. The sole source manufacturer, Bioport Corporation, formerly the Michigan Department of Public Health, is discovered to be a pseudo-military installation, controlled partly by retired military Generals, with funding and onsite management provided by current military officers. Documents gathered through Freedom of Information Act discovery, and those amassed for Congressional hearings, reveal a vaccine the Defense Department long recognized as inadequate, highly reactive, potentially ineffective. Additionally, the vaccine was known to be "unlicensed" and "experimental" for the purpose Commanders were ordering the soldiers of America's armed forces to submit -- for use against inhaled anthrax infection.

FACT: 1995 -- A Defense Department document admits that the anthrax vaccine is "not licensed" properly when used to protect against biological warfare. (7)

We've witnessed Department of Defense officials provide false testimony before Congress. According to the first of the Defense Department's own internal investigations, a General's Congressional Anthrax Vaccine Testimony was "Inconsistent With Honesty." We've also seen senior military officials rebuff Congressional oversight and bully other federal agencies. They have similarly coerced their own commanders, often through inaccurate information, to adhere to the anthrax mandate, regardless of questions about the order's lawfulness. Court-martials of military members became the standard of discipline, with hundreds of discharges, dozens of imprisonments, and even the punishment of a doctor who believed the policy violated his medical profession's Hippocratic oath.

FACT: 1997 -- A Notice of Intent to Revoke (NOIR) the anthrax vaccine manufacturer's license issued by the FDA for violations of Current Good Manufacturing Practices (cGMPs). (8)

The reaction to the concerns of the troops is particularly peculiar in this universe. Rather than address the issues and questions raised by Servicemembers, trained and bound to challenge illegal and immoral orders, the Defense Department disparages, discredits, and disowns those they've trained. Most perplexing of all is that the militaries' memory appears to be only about three years old. Punishment is the order of the day for any soldier who expresses the exact concerns about the vaccine as the militaries' own scientists and doctors did just three years ago, prior to the announcement of the mandatory force wide immunization program. In this Orwellian universe, survival is guaranteed by remembering, "ignorance is bliss."

FACT: 1998 -- The anthrax vaccine plant fails FDA inspection one day after the Defense Department approves the mandatory force wide inoculation program. Manufacturer receives immunity from liability through the Pentagon's power to provide "indemnification" at the taxpayer's expense (9)

All one needs to do is to review the multitude of public documents accumulating on this issue to know that the AVIP is a policy adrift in a universe devoid of integrity and honor, again, at least on this particular issue. Mind numbing clichés such as, "Soldiers must wear their helmets," are coined by military leaders to deflect criticism about the abysmal history of the anthrax vaccine and previous military medical abuses. In this parallel universe we discover Military Officers, cloaked in civilian clothes, swarming Capitol Hill repeating misrepresentations, originating from the Defense Department, and defending the anthrax program with hype and rhetoric about a Military Commander's duty to obey all orders. This becomes the only way to obfuscate a duty to learn the facts and protect soldiers from bad medicine and illegal medical experimentation.FACT: 1999 -- Manufacturer fails another FDA inspection, whileCongress holds hearings and troops are imprisoned. (10)

The anthrax vaccine is "safe, effective, and FDA approved" for use against biological warfare has become a snappy sound bite by military political affairs officers, used to indoctrinate their own Commanders, the media and the nation's lawmakers. Hyping of the threat, and moral imperatives of good order and discipline, rationalize the falsehood, while lockstep obedience defines the requisite attribute of survival in this universe. Challenge the falsity with the ethical and moral obligations expected of US Servicemembers by the people they serve, and you will be cast out. Based on the abandonment of the ill, or intimidation and punishment of any who question, most put on the blinders, and survive.

FACT: 2000 -- Congressional Report published calling the use of the anthrax vaccine "experimental," and recommending program suspension and legal compliance. (11)

The universe we describe may sound like a nightmarish revisiting of a totalitarian regime out of a history book, or premonitions of the oligarchy depicted in the novel "1984", but it is not. We are reluctant witnesses, and unwelcome inhabitants, of this present day universe with respect the Defense Department's conduct and implementation of the anthrax vaccine program. The reality we've discovered documents an instrument, a servant, of our government, the Pentagon, conducting itself in polar opposition to our beliefs, training and values. Just as the child rightly questions and seeks answers to a world seemingly upside down, so too are the Servicemembers, the GAO, and our Congress attempting to keep our military from paralleling the qualities of those militaries we fought in the previous century.

FACT: 2001 -- Defense Department exhausts vaccine stockpile, while FDA continues to maintain that the anthrax manufacturer is "not validated," and the GAO confirms vaccine adulteration due to unapproved manufacturing changes. (12)

Important questions have surfaced which weave into the very fabric of our nation's origins and our founding father's visions. It is never premature to reread the Constitution, or the Federalist Papers, and ponder, is civilian control of the military threatened? Are Servicemembers "citizens first" as George Washington demanded? Will a new mantra of unquestioning obedience to all orders, regardless of legality and morality, be allowed to become the mainstream in professional military education? Clearly, as Benjamin Franklin warned, "justice will not be served until those who are unaffected are as outraged as those who are."

FACT: Estimated damage to date due to the anthrax vaccine program -- over 500 active-duty soldiers punished; over 500 reserve component resignations; over 50 court-martials; and almost 20 imprisonments; plus an intangible loss of trust, morale, and confidence in the current military leadership. (13)

In the future, Americans, and the representatives they elect, must decide what universe the military should operate. In the meantime, if America's armed forces are to be inoculated with an anthrax vaccine, do it right, with a vaccine that's safe, effective and properly FDA approved.

~ References ~
(1) Written Testimony attachments (Public Health Service memorandums) to Dr. Claussen's testimony, 12 OCT 1999, Government Reform Committee hearing on force protection vaccines.

(2) http://www.anthrax.osd.mil/Site_Files/articles/INDEXclinical/Fed_register.htm

(3) Request for Proposals (RFP) No. DAMD 17-85-R-0078, US Army Medical Research Acquisition Activity, Fort Detrick, Frederick, MD, 16 May 1985

(4) Letter from former Assistant Secretary of Defense Robert B. Barker to former U.S. Sen. John Glenn, chairman of the Senate Governmental Affairs Committee, 24 Aug 1989, transcript of Senate Hearing 101-744. The letter and quotes from Barker to Glenn are on page 474 and 480.

(5) Col. (Dr.) Takafuji of the Army Surgeon General office and Col. (Dr.). Philip K. Russell of Fort Detrick, in an article titled "Military Immunizations," describe the anthrax vaccine as a "limited use vaccine ... unlicensed experimental vaccine" (Infectious Disease Clinics of North America, 3/90, p.156), also A. M Friedlander, Col. US Army and P.S. Brachman, ed. Plotkin and Mortimer, 1994 edition chapter 26, pg. 737, "The current vaccine against anthrax is unsatisfactory for several reasons. The vaccine is composed of an undefined crude culture of supernatant adsorbed to aluminum hydroxide. There has been no quantification of the protective antigen content of the vaccine or of any of the other constituents, so the degree of purity is unknown. Standardization is determined by an animal potency test. The undefined nature of the vaccine and the presence of constituents that may be undesirable may account for the level of reactogenicity observed. The vaccine is also less than optimal in that six doses are required over 18 months, followed by annual boosters. There is also evidence in experimental animals that the vaccine may be less effective against some strains of anthrax. Clearly a vaccine that is completely defined, that is less reactogenic, and that requires on or two doses to produce long-lasting immunity would be highly desirable."

(6) Senator Shelby's Conclusions On The Persian Gulf Syndrome, US Senate, 17 Mar 1994, Congressional Record page S3098. See: http://www.gulflink.osd.mil/czech_french/czfr_refs/n08en014/s3098.htm

(7) SAIC Corporation plan, 29 Sep 1995, enclosure to memorandum from Dr. Anna Johnson-Winegar (US Army) to Dr. Robert Myers (MDPH), US Army Medical Research and Material Command, Fort Detrick, Frederick, MD, 5 Oct 1995

(8) Nov 18 - Nov 27, 1997 - FDA inspection report by the Center for Biologics Evaluation and Research, http://www.dallasnw.quik.com/cyberell/Anthrax/Mar97.html

(9) FDA -- inspection report of anthrax vaccine plant (MBPI), 20 Feb 1998

(10) FDA -- inspection report of anthrax vaccine plant (Bioport), 23 Nov 1999 -- "The manufacturing process for the production of Anthrax Vaccine Adsorbed is not validated..."

(11) House Report 106-556, http://www.house.gov/reform/ns/reports/anthrax1.pdf, The Department of Defense Anthrax Vaccine Immunization Program: UNPROVEN FORCE PROTECTION, 17 Feb 2000

(12) FDA/CBER Office of Compliance and Biologics Quality, inspections of Bioport - http://www.house.gov/reform/hearings/healthcare/00.10.03/accountability.doc and GAO testimony to Government Reform Committee on 23 October 2001, http://www.gao.gov/cgi-bin/getrpt?gao-02-181t

(13) 11 Oct 2000 -- ANTHRAX VACCINE: Preliminary Results of GAO's Survey of Guard/Reserve Pilots and Aircrew Members. GAO-01-92T. (PDF file)

~ About the authors ~
Major Russell Dingle and Major Thomas L. Rempfer, both formerly of the Connecticut Air National Guard, were the pilot members of Tiger Team "Alpha," an investigative team formed by their Commander in September of 1998 to convey Servicemembers' concerns about the anthrax vaccine to the chain of command. The officers were forced to resign from their pilot positions in 1999 after the chain of command was either unable or unwilling to address the safety, efficacy, necessity, and legality issues raised by the investigation. Today, their work continues until the anthrax program ceases; all records are expunged; the inoculated ill are properly treated; and the Department of Defense holds itself accountable for its willful and unlawful experimentation on U.S. armed forces members. They maintain that the current AVIP (Anthrax Vaccine Immunization Program) violates 10 USC 1107, EO 13139 and DoD Directive 6200.2 and is therefore illegal without a Presidential waiver of informed consent.