Anthrax Vaccine Immunization Program Process Analysis

Contributor's Corner ^ | 01-25-02 | Maj Thomas L. Rempfer

[backhoe]

 

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From: TRempfer@aol.com

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Sent: Thursday, January 24, 2002 1:46 PM

Subject: Aerospace Power Chronicles Essay on the Anthrax Vaccine

Excerpt:

Anthrax Vaccine Immunization
Program Process Analysis

by Maj Thomas L. Rempfer, USAFR
Maj Russell E. Dingle, USAFR

The military is by definition and necessity a results oriented organization. In order to achieve the myriad results that the President desires of the military, the Secretary of Defense (SECDEF) institutes and oversees programs designed to attain those results. The success of any program is dependent on the results of the various processes used in the attainment of those program goals. Examples include regulatory, logistical, medical, ethical, and policy processes.

To temper the tendency for mission, or results, oriented myopia, the military takes process analysis one-step further through Operational Risk Management (ORM) and Total Quality Management (TQM). These leadership and management tools allow military members to continually evaluate and identify hazards, assess and analyze risks, and review the process to ensure the ORM bottom-line is protected for the safety of the troops: "If it’s not worth the risk, don’t do it" (Source: USAF Operational Risk Management training materials).

President Clinton desired to protect his military forces against the biological warfare agent aerosolized or inhalation anthrax. President Clinton tasked Secretary of Defense Cohen in 1997 to institute a program that would result in force protection against inhalation anthrax.1 The success of Secretary Cohen’s Anthrax Vaccine Immunization Program (AVIP) was dependent upon the results of the processes used in researching, developing, and implementing a program that would achieve President Clinton’s goal. The processes involved in the research and development of the anthrax vaccine, and the implementation of the AVIP, will be reviewed in this paper.

In the case of the AVIP, a process analysis of the vaccine’s history should have dictated the ORM bottom-line to kick in: "it’s not worth the risk, don’t do it." The vaccine was known to be too reactive, of limited effectiveness, and the Food and Drug Administration (FDA) shut down the manufacturer for significant quality control violations. Members of the Joint Staff, soldiers, and even field level commanders expressed this view at various times prior to and during the implementation of the AVIP.2 Yet, at some level within the Office of the Secretary of Defense or the Executive branch, the analysis was ignored, and the required "knock it off," demanded when the safety of the troops is placed in jeopardy, never occurred.

As a result of this fundamental military objective process breakdown, historic regulatory mistakes were compounded, and laws were circumvented. Processes were not followed, but instead "adulterated" to fit the military objective desired by the Commander in Chief and the SECDEF. The medical AVIP force health protection initiative was taken out of the military doctor’s hands by deeming AVIP a "Commander’s Program."3 Now, a military objective, AVIP became an order to be followed. Any soldier who employed ORM and TQM in evaluating the AVIP was rebuffed or punished in the name of "good order and discipline." The AVIP became widely recognized as a bad order, and by many an illegal one. Honest process evaluation of a legitimate safety and ethics issue was substituted by mandatory blind obedience.

As officers in the Connecticut Air National Guard in the fall of 1998, our commander tasked us to look for answers to questions on the anthrax vaccine that he was being asked by subordinates. Absent any answers, we were tasked to develop those questions concerning the anthrax vaccine, so they could be forwarded up the chain of command. In effect, we were tasked to look at the processes revolving around the AVIP, and how it impacted our unit. Our initial process analysis revealed a stark dichotomy between the facts readily available in medical literature and government documents, when compared to the rhetoric espoused by Defense Department sources. Our subsequent and ongoing analyses of the legal, doctrinal, ethical, policy and medical aspects of this debacle discovered a complex ethical and process breakdown, within the chain of command, and throughout our government, on this particular issue, the AVIP.4 ...


The remainder of this essay and it's references are available at:

Click here: Contributor's Corner

http://www.airpower.maxwell.af.mil/airchronicles/cc.html

or

Click here: Anthrax Vaccine Immunization Program Process Analysis

[backhoe]

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[aristeides]

The Russians have offered us their anthrax vaccine. According to Ken Alibek, it is far superior to ours. Why haven't we taken the Russians up on their offer?

[backhoe]

Good question... and one I can't readily answer. The deeper you look into this subject, the weirder it gets.

[Grut]

The military is by definition and necessity a results oriented organization.

Faulty premise. The military is a 'keep-the-boss-happy' oriented organization and since the CINC wanted to do 'something' about the anthrax threat, nothing was allowed to get between the immediately doable (or so it was thought) vaccination program and the troops.

Inevitably, many midlevel bosses, in the interests of their careers (AKA 'sucking-up'), committed to the vaccination program. They must now also be kept happy by their subordinates, giving the program enormous bureaucratic mass. Don't expect any serious review of the program absent either a court decision or a Presidential order.

[DaRocksMom]

Thanks for posting backhoe. I still have yet to read the whole essay. You stated weirder. Not so weird. Just follow the money, power, and influence than you have all the answers.

[backhoe]

You're right, of course... an old-time word I like a lot is--

Main Entry: cor·rup·tion
Pronunciation: k&-'r&p-sh&n
Function: noun
Date: 14th century
1 a : impairment of integrity, virtue, or moral principle : DEPRAVITY b : DECAY, DECOMPOSITION c : inducement to wrong by improper or unlawful means (as bribery) d : a departure from the original or from what is pure or correct

Not included in this online def is "turning away from the right path...."

[Betty Jo]

Well, lets see....We dont trust the Russians?

We think their vaccine isnt any good?

Who was it tested on?

Do they realy try to infect someone, and then vaccinate?

If the person dosnt get it, the vaccine is good?

Are there dead Americans and Ruskies in the ground from bad vaccine,they died from anthrax?

It is all so weird!