Homeland Security Watch

News and analysis of critical issues in homeland security

February 4, 2010

“Check Six” — The Ethics of Anthrax Knowledge

Filed under: General Homeland Security,Technology for HLS,Terrorist Threats & Attacks — by Christopher Bellavita on February 4, 2010

Ethics question: Let’s say you are a military officer whose Oath of Office requires you to disobey an order that violates the Constitution of the United States.

You believe – for reasons that appear almost Talmudic to someone unversed in the details – that the order to be inoculated with an “unapproved anthrax vaccine” is illegal.

You go through the authorized procedures to make your case, including going to federal court.  You lose your case, but not — you believe — on the merits.

Almost one thousand service men and women refuse to receive the inoculation and are punished. You think the punishment was wrong because the order they are accused of disobeying was illegal.

You go on with your life and career.  But you learn that many more doses of the unapproved vaccine are now included in the Strategic National Stockpile.  What do you do?  Do you let it go and just keep your fingers crossed hoping the vaccine is never needed?  Do you trod further down the Quixotic path to battle even more windmills?  Do you stop trying to have the records expunged of those service members you believe were illegally punished?

A few days ago, Edward Jay Epstein  published an article in the Wall Street Journal claiming the Anthrax Attack of 2001 is still an open case.  Reading the article reminded me of the officer’s dilemma.  And a confusing story — at least to me — gets even more confusing.

In a May 2009 article the officer wrote about the vaccine, he noted the

Justice Department alleged the anthrax vaccine program’s “failing” status served as the stated motive in the 2001 anthrax letter attacks. By sending anthrax through the U.S. mail system, the perpetrator was attempting to create a situation where the government might recognize a renewed need for the vaccine.

What does all this mean?  As best as I can summarize:

  • The particular anthrax vaccine was never proven effective.
  • Allegedly, one of the U.S. scientists involved with developing the vaccine sent anthrax through the mails to create demand for more research.
  • It was that vaccine service members were required to take.
  • It is that vaccine that has been included in the Strategic National Stockpile, to be used on civilians if there is a need.

What is the ethically correct action for the officer who believes this to be the case?

——————————————————————

The guest author for today’s post is Lieutenant Colonel Tom Rempfer.  LtCol Rempfer is a distinguished graduate of the U.S. Air Force Academy, and an Air Force Command pilot, experienced in F-16s, F-117s, A-10s, and MQ-1s. His prior service included membership on the U.S. Air Force Cyberspace Task Force, as well as flight safety and operational risk management duties. He recently graduated with a homeland security master’s degree from the Naval Postgraduate School.  His thesis — available at this link — is titled: ANTHRAX VACCINE AS A COMPONENT OF THE STRATEGIC NATIONAL STOCKPILE:  A DILEMMA FOR HOMELAND SECURITY.

If you are one of the people interested in the 2001 anthrax attacks, or anything related to it, LtCol Rempfer’s thesis is worth a read.

——————————————————————
“Check six.”  Fighter pilots use this term to warn fellow aviators to look to their six o’clock position and avoid impending threats.  This is the objective of Lieutenant Colonel Tom Rempfer’s Naval Postgraduate School Center for Homeland Defense and Security thesis.

The thesis details the history of the anthrax vaccine incorporated into the Strategic National Stockpile after the anthrax letter attacks of 2001.  Prior to that time, the vaccine suffered from unapproved manufacturing changes, GAO documented potency increases, controversies over Gulf War Illness, quality control problems, threatened FDA notices of license revocation, Department of Defense (DoD) plans to replace the vaccine and recommendations by the George W. Bush administration to minimize its use in August 2001.

According to the FBI, the anthrax letter attacks in the fall of 2001 by a US Army scientist successfully rekindled demand and overcame the vaccine’s “failing” status.  Since those attacks, DoD leaders leveraged the crimes to revive the anthrax vaccine program and the Department of Homeland Security (DHS) endorsed the purchase of over $1 billion for the Strategic National Stockpile, all while federal courts declared the program illegal due to the vaccine’s lack of proper licensing.

The author’s involvement with the DoD anthrax vaccine controversy spanned the ten years preceding his Master’s degree.  He challenged the program in accordance with his Oath of Office, which demanded military orders adhere to the law.

LtCol Rempfer testified to Congress and his legal efforts to seek accountability continue with a recently filed Writ of Certiorari to the Supreme Court and an ongoing case with the Board for Correction of Military Records.  Well documented alliances in his pursuit of justice include Connecticut legislators such as Attorney General Richard Blumenthal, Senator Christopher Dodd,  former Representative Christopher Shays, and a tenacious Veteran advocate, Mr. H. Ross Perot.

The author’s ultimate goal to expunge the records for the almost one thousand Servicemembers wrongfully punished for refusing to comply with the illegal mandate serves as a backdrop, as well as his goal for proper care for those harmed by the vaccine.

The thesis describes unhealthy precedents where illegal policy, resuscitated through bioterrorism, could lead to dramatic expenditures and expanded use of the vaccine for the civilian population.  The author recommends the government resurvey the use of the vaccine for the American people and suggests the new administration should “check six” by ensuring Homeland Security Presidential Directive reviews support vaccine stockpiling in light of the proven efficacy of antibiotics, as recommended by the Centers for Disease Control (CDC).

The thesis encourages a Presidential Study and Policy Directive process to review systemic problems associated with the anthrax vaccine from a historical lens.  In doing so, DHS Secretary Napolitano protects the Obama Administration from being duped into adopting historically plagued, unnecessary and wasteful policy.

——————————————————————

Update: I received the following additional information from LtCol Rempfer a few hours after the original post:

One clarification: the current “lost” case is under appeal, so it’s not over ’till it’s over.

Plus, there’s another case at the corrections board which is an effective win.  The court agreed with my position, ordered the DoD to address records corrections, but the DoD has simply done nothing to correct the wrongs. That case is now headed back to court too, to compell the DoD to do the right thing.

These two latest cases were preceded by a complete win in a separate case.  The government was found to have violated the law because the vaccine was never licensed by the FDA until 2005, six years after they ordered service members to take the vaccine and punished those who refused.

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9 Comments »

Comment by Sarah Chapman

February 4, 2010 @ 11:33 am

For readers who are not members of the Homeland Security Digital Library, Mr. Rempfer’s thesis can be found at http://www.chds.us/?chds:research/thesis

Comment by christie mcneil

February 4, 2010 @ 11:36 am

While serving with the AF, I witnessed hundreds of service members being forced to take this vaccine as well our Flight Surgeon/Wing commander Not Allowing Any reports of adverse effects to be reported. When I checked the Vaccine source I found numerous things Wrong.The manufacturer, the type of anthrax included..compared to the type potentially exposed to in the field was very questionable and There was Never any tests done on the actual batchs we were issued and the batches were outdated as well. I was the NCOIC of Medical Readiness and could Not do this to my fellow service members. I was Officially ‘released from duty’/forced to take an early retirement because I refused to go along with this outrageous conduct.
Is there any potential that these dishonorable and health threatening ways can be addressed and prevented in the future?

Comment by William R. Cumming

February 4, 2010 @ 8:15 pm

Okay back to basics! How does anyone determine that the Constitution has been violated? How does a serving member of the Armed Forces determine an order given under “color of authority” is in fact unConstitutional? Leaving completely aside those questions let’s go to anthrax and vaccine production.

Washington ordered the vaccination of his troops against smallpox. It was not accepted practice medically at the time. The Armed Forces have been leaders at various times in adoption of medical procedures. Is failure to receive a vaccination ordered a failure of conduct or of performance? This is really an interesting matter as we face a future of various kinds of drugs that will enhance performance or keep performance from being diminished? The question I have is with respect to the Armed Forces–does not the Hippocratic Oath state “first do no wrong?”

Look forwards to reading the paper! It should be stated that unathorized medical experiments have been repeated documented with respect to active duty military who “volunteer” for participation. Notice how to my knowledge the Armed Forces, including the Service Academies, don’t really have ethics courses for cadets or officers or the ranks. But could be wrong as always.

Comment by Buzz

February 5, 2010 @ 9:12 am

My appreciation to Chris for posting the paper. I go by “Buzz,” and served as the paper’s author.

RE William’s contention that military members are volunteers for participation in “unauthorized medical experiments,” 10 U.S.C. 1107, the law, specifically prohibits mandated experiments absent a waiver of informed consent by the President. The Presidential waiver never occurred with the anthrax vaccine, and the Federal Courts determined the vaccine’s experimental status required informed consent prior to the FDA licensure of the vaccine in December 2005.

Comment by William R. Cumming

February 6, 2010 @ 10:40 am

Thanks Buzz! I assume the statute referrenced is non-delegable but you should note that 3 USC Section 301 allows the President to delegate any of his authority. Not sure if the lawyers and judges searched for a delegation or not. Also not sure how this blanket authority to delegate would be interpreted if put to the test. Normally,the statutory construction rule is that if at all possible you construe so as to avoid conflicts between two federal statutes. In the case of a direct conflict the later in time of enactment would control.

There is NO “Color of Authority” argument to be made in the Executive Branch or Armed Forces. Under the principal established by SCOTUS in 1803, Little v. Bareme, you either have the authority or you do not.

Comment by Buzz

February 7, 2010 @ 12:09 am

Interesting provision William – thank you. In this particular case, the government never contended the authority was delegated. As a result, the court determined the anthrax vaccine program violated 10 U.S.C. 1107.

Other courts affirmed the “undisturbed” findings when ruling the anthrax vaccine mandate was “a violation of federal law for military personnel to be subjected to involuntary AVA inoculation because the vaccine was neither the subject of a presidential waiver nor licensed for use against inhalation anthrax.”
(See analysis of precedent at pp. 5-8 and conclusion on p. 19: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2005cv2350-31)

The case referred to, Doe v. Rumsfeld is available at the following link: http://www.anthrax.mil/documents/library/AnthraxSJtOrder_Op.pdf.

Comment by Jason

February 8, 2010 @ 10:46 am

I don’t know what’s more disturbing, that you give this individual the political stage to perpetuate his false story about anthrax vaccination and the implications on DHHS’s strategic national stockpile, or that you accept his story without offering any explanation as to why DOD continues to vaccinate service members with the same vaccine and why DHHS still stockpiles it.

Could it be that the individual’s “beliefs” are in fact not science-based but rather fear-based on the limited possibility that he might be affected by the vaccine and unable to continue a plush second career in the airlines industry? Could it be that the federal courts and the FDA are in fact completely justified in their decisions based on a review of the decades of use of this same vaccine? Could it be that the millions of administered doses have in fact such a small percentage of adverse effects that it makes other vaccines – like the flu -seem hazardous?

Your reporting of this case and encouragement of the individual is misplaced. You would do much better to learn the facts about anthrax vaccine and policy debates on this issue than to follow the emotion-based case that this individual presents.

Comment by Buzz

February 8, 2010 @ 3:28 pm

Jason, thank you for your inputs. I see this blog more as an opportunity for you to explain your disagreements with the paper. Looking for specifics, please? The argument encouraging review is fact-based, whereas your post appears to be emotion-based, ad hominem in nature, and raises unrelated issues about airline careers not mentioned in the paper or blog. Your perspective is appreciated, but we need relevant, on-issue substance in order to respond to.

Comment by Buzz

February 23, 2010 @ 3:25 am

Supplemental findings in 2/19/2010 FBI report relevant to the thesis:

See: http://www.justice.gov/amerithrax/docs/amx-investigative-summary.pdf

RE p. 8:
2. Motive. According to his e-mails and statements to friends, in the months leading up to the anthrax attacks in the fall of 2001, Dr. Ivins was under intense personal and professional pressure. The anthrax vaccine program to which he had devoted his entire career of more than 20 years was failing. The anthrax vaccines were receiving criticism in several scientific circles, because of both potency problems and allegations that the anthrax vaccine contributed to Gulf War Syndrome. Short of some major breakthrough or intervention, he feared that the vaccine research program was going to be discontinued. Following the anthrax attacks, however, his program was suddenly rejuvenated.

RE p. 21
At the time of the anthrax mailings in 2001, a bio-:Anthrax vaccine production pharmaceutical company headquartered in Michigan was the sole provider of anthrax vaccine to the U.S. Department of Defense (“DOD”). The company’s vaccine was the only anthrax vaccine licensed by the U.S. Food and Drug Administration (“FDA”) for human use in the United States. In the aftermath of the 2001 anthrax mailings, the FDA granted this company long-sought approval to continue production of its vaccine, which had previously been suspended for the company’s violation of Good Manufacturing Practices. This approval positioned the company to reap substantial profits from the increased demand for its vaccine generated by the anthrax attacks.

RE p. 38
D. Motive
… Dr. Ivins was under an extraordinary amount of stress in his professional life. The anthrax vaccine research program that Dr. Ivins had invested essentially his entire career of more than 20 years was in jeopardy of failure. The anthrax vaccine with which he was assisting was failing to meet potency standards and, absent some major breakthrough, may have been eliminated. Also, the military anthrax vaccine, and Dr. Ivins, in particular, were the subject of increasingly vocal criticism by those who associated the vaccine with “Gulf War Syndrome.” Finally, the rPA, or Next Generation Anthrax Vaccine, on which he was also working, had run its course at USAMRIID, leaving him potentially without anthrax research to do. According to Former Colleague #1 and others, Dr. Ivins not only took great pride in his work, but also he could not stand to be criticized. Under extreme pressure from so many different assaults on his career and life’s work, Dr. Ivins had a motive to commit the crime.

RE p. 39
1. Dr. Ivins’s life’s work appeared destined for failure, absent an unexpected event.
Beginning as far back as 2000, Dr. Ivins was sending e-mails to Former Colleague #1 expressing his increasing concern and eventual frustration that a private company tasked with producing the anthrax vaccine, was unable to produce anthrax vaccine that met the required potency standard, even though he and other USAMRIID researchers were spending an increasingly large percentage of their time trying to help that company fix it. As the Office for the Assistant Secretary of Defense for Public Affairs stated in a news release on June 11, 2001, the Anthrax Vaccine Immunization Program was being slowed due to a shortage of that vaccine. Vaccination would continue for special mission units and research purposes only. “This slowdown provides for a small reserve of FDA-released vaccine in the event of an emergency. Actions are being taken to ensure that personnel deployed to high-threat areas have sufficient antibiotics on hand for post-exposure treatment in case of an attack.”
Pressure on the project increased throughout the summer. By the first week of September 2001, Dr. Ivins was sending Former Colleague #1 e-mails stating that USAMRIID was down to its last approved lot of the vaccine, after which – if the company could not get FDA approval to resume production or make available lots meet current potency standards – the vaccine would be completely depleted. This would have been a major problem, not only because the vaccine was needed for the soldiers out in the field, but also because it was needed for the researchers themselves, including Dr. Ivins, who would not be permitted to enter the hot suites and work with anthrax unless their vaccinations were up-to-date. Unless this company could fix the problem, Dr. Ivins himself in short order would have had a very difficult time continuing his anthrax research because he would have lacked the vaccinations to do so.26
However, within a few months of the anthrax attacks, the FDA fast-tracked the approval process and approved the Anthrax Vaccine Adsorbed (“AVA”), even though it didn’t meet the original potency standards [emphasis added]. This was a significant development for the anthrax researchers.

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