Mr. Ken Bacon,

Assistant Secretary of Defense for Public Affairs

Dr. Sue Bailey, M.D.

Former Assistant Secretary of Defense for Health Affairs

LTG (Dr.) Ronald Blanck, D.O.

Retired former U.S. Army Surgeon General

Dr. Gerard N. Burrow, M.D.,

Professor of obstetrics and gynecology, Yale University Medical School and DoD's "independent expert" on anthrax vaccine

Hon. William S. Cohen

Secretary of Defense

Mr. Charles Cragin

Principal Deputy Assistant Secretary of Defense for Reserve Affairs

Hon. Rudy de Leon

Then-Undersecretary of Defense for Personnel and Readiness

(now Deputy Secretary of Defense)

COL (Dr.) Arthur Friedlander, M.D.

Chief, bacteriology division, U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID)

Mr. Fuad El-Hibri

President and Chief Executive Officer, BioPort Corporation

Dr. Robert Myers, D.V.M.,

Chief Operating Officer, BioPort Corporation. and

former Executive Director, Michigan Biologic Products Institute

Mr. David Oliver (RADM, USN, ret.)

Principal Deputy Under Secretary of Defense For Acquisition And Technology

Maj Guy Strawder,

Former Director of the US Army AVIP Agency

MGen Paul Weaver

Director of the Air National Guard

Kathryn C. Zoon, Ph.D.,

Director, FDA Center for Biologics Evaluation And Research

Issue:

DoD denials of adverse reactions.

Question(s):

Why have DoD public affairs officials repeatedly denied adverse reactions caused by the anthrax vaccine, while anthrax vaccine victims were simultaneously being treated at Walter Reed Army Medical Center and being visited by the Army Surgeon General, LTG Blanck?

Who said it:

Mr. Ken Bacon, Assistant Secretary of Defense for Public Affairs

Statement

Fact

Comments at a DoD press briefing, 21 Jan 1999:

"It's proven itself safe and reliable. It works, and it does not have side effects... We have given now I think shots to nearly 170,000 people in the military... All these people are fine."

Comments at a DoD press briefing, 30 Jun 1999:

" I've had three shots. My hair is growing more robust than ever. (Laughter) I sleep better. I eat better, run farther. It's been nothing but a great experience. (Laughter)"

• Dr. Renate Engler, the chief of immunology at Walter Reed Army Medical Center addressed a conference on the anthrax vaccine policy at Ft Detrick Maryland on 25-27 May 1999. During her address she described "Chronic Illness Perceived as Linked to Anthrax Vaccine: Dover AFB". She went on to observe:
• "Potentially more than 25 individuals from same location, having received anthrax vaccinations
around the same time & from same lot, growing "belief" that anthrax has caused potentially long term, indefinite, untreatable disease!"
• "Fear of military medical establishment: affected service members fail to report"
1. The patients described by Dr. Engler in her briefing at Ft Detrick in May 1999 reported having chronic systemic reactions to the anthrax vaccine during the fall of 1998 -- well before Mr. Bacon's comments discrediting the idea of serious adverse reactions to the vaccine.

Issue:

Squalene in anthrax vaccine. Misleading servicemembers, military families, and the American public about the existence of an unapproved substance in the DoD anthrax vaccine.

Question(s):

Why does Mr. Bacon, the Assistant Secretary of Defense for Public Affairs, still issue categorical denials of the existence of squalene in the anthrax vaccine 15 months after FDA experts found it in five lots of anthrax vaccine?

Who said it:

Mr. Ken Bacon, Assistant Secretary of Defense for Public Affairs

Statement

Fact

At a DoD press briefing, 28 Sep 2000:

Reporter: On the same subject, what can you say about reports that squalene has been found in some of the vaccine lots?

Bacon: There have been recurrent reports of squalene. We have never found any confirmation of those reports. These reports go back to the

use of anthrax vaccine during the Gulf War period. Squalene has not been used in vaccines for a long period of time, and we're not aware that there was any squalene in any of the vaccine.

1. Contrary to Mr. Bacon's assertion, the FDA has found squalene in five of five lots it has tested for the presence of squalene. These tests were performed in Jun 1999, but were not disclosed by FDA until 20 Mar 2000, in a letter to Congressman Jack Metcalf (R-WA).
2. According to the FDA (CBER), the FDA did find squalene in the five lots of anthrax vaccine on 23 and 24 June 1999. The test results follow:

AVA 020 11 ppb squalene

AVA 030 10 ppb

AVA 038 27 ppb

AVA 043 40 ppb

AVA 047 83 ppb

Diphtheria 22 ppb

Tetanus 29 ppb

3. While the impact of squalene is under debate, it is clear that DoD was wrong about the presence of squalene in the vaccine. DOD has not corrected their denials to Servicemembers or to Congress.

Issue:

SecDef Cohen's 4 preconditions for implementing AVIP. Misrepresenting to Congress that DoD's "independent expert" contracted to perform a review of the medical aspects of the anthrax vaccine policy was qualified to review the safety of the anthrax vaccine.

Question(s):

Why did Dr. Bailey, a physician herself, infer to Congress that a professor of obstetrics and gynecology who subsequently admitted to "no expertise in anthrax" was qualified to perform DoD's "independent review" of the AVIP?

Who said it:

Dr. Sue Bailey, then-Assistant Secretary of Defense for Health Affairs

Statement

Fact

In testimony before the House Government Reform Subcommittee chaired by Congressman Shays, 24 March 1999:

Dr. Bailey. "The safety of our AVIP was also confirmed by an independent review of the program. Dr. Gerald Burrow, who serves as Special Advisor for Health Affairs for the President of Yale University, conducted the review."

Dr. Gerard Burrow's letter to Congressman Christopher Shays, 26 April 1999:

"The Defense Department was looking for some [sic] to review the program in general and make suggestions, and I accepted out of patriotism. I was very clear that I had no expertise in Anthrax and they were very clear they were looking for a general oversight of the vaccination program."

Issue:

Endorsements of anthrax vaccine. Misrepresenting to Congress the American Academy of Pediatrics position on the anthrax vaccine.

Question(s):

Why did Dr. Bailey, a physician, use an out-of-date policy statement from the American Academy of Pediatrics to infer to Congress that this organization endorsed the anthrax vaccine?

Who said it:

Dr. Sue Bailey, then-Assistant Secretary of Defense for Health Affairs

Statement

Fact

Dr. Bailey. "In addition, the Committee on Infectious Disease, American Academy of Pediatrics (1994), states that "the vaccine is effective in preventing or significantly reducing the occurrence of cutaneous and inhalation anthrax in adults."

1. The 24^th edition of the American Academy of Pediatrics Committee on Infectious Disease most recent recommendations, published in 1997 -- two years before Dr. Bailey's testimony -- does mention the anthrax vaccine, but removed the statement that the vaccine was effective for inhalation anthrax:

"The vaccine is effective in preventing or significantly reducing the occurrence of cutaneous anthrax in adults, and it causes minimal adverse events. No data on vaccine effectiveness or reactogenicity in children are available, and the vaccine is not currently licensed for use in children or pregnant women."

2. The 25^th edition of the Academy of Pediatrics Committee on Infectious Disease most recent recommendations, published in 1997 states:

"The vaccine is effective for preventing or significantly reducing the occurrence of cutaneous anthrax in adults, and it causes minimal adverse events. While protection against aerosol challenge has not been evaluated in humans, multiple studies in animals have shown the vaccine to be effective. No data on vaccine effectiveness or safety in children are available, and the vaccine is not licensed for use in children or pregnant women."

3. Even if the data on efficacy in animals was conclusive, which it is not, efficacy tests in animals to not meet federal regulatory standards for licensure of a product for a specific purpose. The FDA did not propose new rules to allow animal tests to be substituted for human efficacy tests until 5 Oct 1999, and has not yet implemented such a change into federal law.

Issue:

Squalene in anthrax vaccine. Misleading servicemembers, military families, and the American public about the existence of an unapproved substance in the DoD anthrax vaccine.

Question(s):

Why does the Department of Defense still have categorical denials of the existence of squalene in the anthrax vaccine on their AVIP website over 15 months after FDA experts found it in five lots of anthrax vaccine?

Who said it:

Dr. Sue Bailey, then-Assistant Secretary of Defense for Health Affairs

Statement

Fact

Comments in a DoD News Service article on 24 Jun 1999, which was still on the DoD Defenselink website on 28 Sep 2000:

Bailey countered reports that the vaccine was somehow tainted with a substance called squalene. Squalene is a substance that appears naturally in everyone’s body, she explained. "You also find it in a lot of beauty products

and in some health food products," she said.

"But, squalene has never been used in the anthrax immunization vaccine production, and it is not now present."

Following the reports, DoD contracted with a civilian laboratory that tested the vaccine for squalene and "found there is no squalene in the anthrax vaccine we are using," she said.

1. Contrary to Dr. Bailey's assertion, the FDA has found squalene in five of five lots it has tested for the presence of squalene. These tests were performed in Jun 1999, but were not disclosed by FDA until 20 Mar 2000, in a letter to Congressman Jack Metcalf (R-WA).
2. According to the FDA CBER) the FDA did find squalene in the five lots of anthrax vaccine on 23 and 24 June 1999. The test results are the following:

AVA 020 11 ppb squalene

AVA 030 10 ppb

AVA 038 27 ppb

AVA 043 40 ppb

AVA 047 83 ppb

Diphtheria 22 ppb

Tetanus 29 ppb

While the physiological impact of these amounts of squalene is subject to debate, it is clear that DoD was wrong about the presence of squalene in the vaccine. And it has never issued a statement correcting their denials to either servicemembers or to Congress.

Issue:

Safety and efficacy. Misrepresenting to Congress that adequate studies of the safety and efficacy of the anthrax vaccine exist.

Question(s):

Why did LTG Blanck, the Army Surgeon General, tell the House Armed Services Committee that "a group reviewed all of the studies on safety and efficacy" of the anthrax vaccine, when, in contrast, the Institute of Medicine later found "a paucity of published peer-reviewed literature on the safety of the anthrax vaccine -- in fact, only one 38 year-old study of a different anthrax vaccine"?

Who said it:

LTG Ronald Blanck, then-Army Surgeon General

Statement

Fact

In testimony before the House Armed Services Subcommittee on Military Personnel, 30 Sep 1999:

"The most recent paper in vaccine done by a group reviewed all of the studies on safety and efficacy, and that was published in 1998, and their conclusion was, we see no reason for further studies on safety. This is a safe vaccine. We believe it to be effective based on the studies that we have."

• "There is a paucity of published peer-reviewed literature on the safety of the anthrax vaccine. The committee located only one randomized peer-reviewed study of the type of anthrax vaccine used in the United States (Brachman et al., 1962). However, the formulation of the vaccine used in that study differs from the vaccine currently in use."

• "There have been no studies of the anthrax vaccine in which the long-term health outcomes have been systematically evaluated with active surveillance."

• "The committee concludes that in the peer-reviewed literature there is inadequate/ insufficient evidence to determine whether an association does or does not exist between anthrax vaccination and long-term adverse health outcomes. This finding means that the evidence reviewed by the committee is of insufficient quality, consistency, or statistical power to permit a conclusion regarding the presence or absence of an association between the vaccine and a health outcome in humans."

Issue:

Investigational New Drug application. Misrepresenting to the Senate Armed Services Committee that the Investigational New Drug application prepared by the U.S. Army (USAMRIID) for the anthrax vaccine manufacturer to submit to the FDA on 20 Sep 1996 applied only to the facility, not to the vaccine.

Question:

1. Was the Investigational New Drug application submitted by the anthrax vaccine manufacturer (MBPI) on 20 Sep 1996, a product license amendment for the manufacturing facility or for the anthrax vaccine itself?
2. When LTG Blanck stated to the Senate Armed Services Committee that the IND application was "really for the facility" was that a true statement?

Who said it:

LTG Ronald Blanck, then-Army Surgeon General

Statement

Fact

Sen. Roberts: "General Blanck, the annual Congressionally mandated chemical and biological defense program report to Congress submitted on March 15, 2000, states: "The Department submitted data to the FDA last year to license the vaccine to provide protection against aerosol exposure to anthrax." My question is why is the Department seeking a license for the vaccine when the license for

the anthrax vaccine has existed since 1970?"

Gen. Blanck: "It is really for the facility, not for the vaccine per se."

Sen. Roberts: "Oh, I see, okay. All right. That clears that up."

1. The Investigational New Drug application was specifically for anthrax vaccine absorbed (AVA) and the modification sought by the manufacturer, at the request of and with DoD assistance, and will apply regardless where the anthrax vaccine is manufactured.
2. The 20 Sep 1996 IND application
cover letter from the manufacturer, Michigan Biologic Products Institute, contains no mention of the facility. It simply states:

"The purpose for filing this IND is to conduct clinical investigations designed to investigate changes in the approved labeling for the licensed product. The potential labeling changes would affect the specific clinical indication, route, and vaccination schedule for AVA [anthrax vaccine absorbed]."

3. The IND application was submitted following an Army, Joint Staff, and OSD staff process in which there was concurrence that it was necessary to obtain FDA approval of a new licensed indication for inhalation anthrax before DoD could start mass anthrax vaccinations. That consensus was reversed within a month of Mr. William Cohen being confirmed as SecDef, following DoD pressure on FDA to give permission to begin vaccinations without obtaining a new licensed indication.

Issue:

Independence of DoD's "Anthrax Vaccine Expert Committee"(AVEC). Misrepresenting the autonomy of the panel of experts commissioned by DoD to review anthrax vaccine adverse reaction reports (VAERS).

Question(s):

1. Do DoD representatives participate in all meetings of the Anthrax Vaccine Expert Committee, and if so, why?
2. Are representatives of those opposed to the anthrax vaccine allowed to participate in meetings of the Anthrax Vaccine Expert Committee?
3. How can a committee of experts commissioned by a DoD Agency be relied upon to issue reports that are unfavorable to a program closely associated with the Secretary of Defense?

Who said it:

LTG Ronald Blanck, then-Army Surgeon General

Statement

Fact

Written testimony submitted by LTG Blanck before the Military Personnel Subcommittee of the House Armed Services Committee, 30 Sep 1999:

"The AVEC represents a special panel of experts commissioned by the AVIP Agency in early 1998 to review any signaling event that would identify problems stemming from the anthrax vaccine. These experts come from the Health Resources & Services Administration (HRSA); a component of the Department of Health & Human Services sponsored Vaccine Injury Compensation Program (VICP). To date, the AVEC has found no pattern of causality stemming from the use of the anthrax vaccine."

1. The Army's concern about the Anthrax Vaccine Expert Committee operating too independently was revealed in an internal email sent by COL Frederick Gerber, Director, Health Care Operations, Office of the Army Surgeon General on 22 Oct 1998. COL Gerber was intent on insuring that the Army had a representative at the first AVEC meeting, which occurred on 26 Oct 1998. The text of his email reads:

Subject: Re: FW: Vaccine Expert Panel Review of Anthrax Vaccine

Author: COL Fred Gerber

Date: 10/22/98 11/20 PM

"OK, but you see the problem with us not being there is…NOT being included in the loop of what's already been done re: fixing the VAERS report form and procedures, etc. Last thing we want is them coming up with an entirely new solution set up after we've already worked one. Think about this one and be sure we don't let them [AVEC] go down a road we don't need going down."

2. In fact, at least three DoD representatives attended the first AVEC meeting
on 26 Oct 1998: Dr. Phillip Pittman of USAMRIID, Ft. Detrick, MD; CAPT David Trump of OSD Health Affairs, and Ms. Cathy Call of the Office of the Army Surgeon General.

Issue:

Relevance of animal models for human efficacy. Misrepresenting to the House Armed Services Committee that the FDA has accepted animal models as a legal substitute for efficacy testing

Question(s):

1. Has the FDA amended federal regulations to now accept animal studies as substitutes for human efficacy studies?
2. Are there currently any peer reviewed scientific studies that establish correlates of immunity between humans and animals for the purpose of testing efficacy of vaccines that would allow an amendment of federal regulations as proposed by the FDA in a Notice of Proposed Rulemaking on 5 Oct 1999?
3. If the FDA does not accept animal tests as acceptable alternatives to legally required human efficacy tests required for vaccine licensure, then of what legal relevance are the guinea pig, rabbit, and primate tests which DoD continually uses to assert the safety and efficacy of the vaccine?

Who said it:

LTG Ronald Blanck, then-Army Surgeon General

Statement

Fact

Before the House Armed Services Committee on 30 September 1999:

Gen. BLANCK. "So what we have done with full FDA concurrence is develop several animal models, and that is part of how we know that this protects against the strains…the mechanism and all of that kind of thing."

1. The Investigational New Drug (IND) application prepared by the US Army, and submitted by the anthrax vaccine manufacturer (MBPI) to the FDA on 20 Sep 1996 proposed establishing animal models as a "correlate for immunity" in humans. This is an exception to current federal law, which requires human studies to prove efficacy.
2. The FDA did not even propose rules for allowing animal studies to substitute for human studies until it issued a Notice of Proposed Rulemaking on 5 Oct 1999 -- three years after the submission of the IND application, and 19 months after AVIP immunizations began. The FDA still has not amended the regulations, and thus has not accepted as valid any animal models as substitutes for legally required efficacy tests for vaccine licensure. Therefore, LTG Blanck's mention of animal tests is misleading, because they are irrelevant with respect to meeting the requirements of federal law (Food, Drug, and Cosmetic Act).

Issue:

Efficacy against multiple strains. Misrepresenting to the House Armed Services Committee the efficacy of the anthrax vaccine against all strains of anthrax.

Question(s):

1. Does LTG Blanck's statement that the anthrax vaccine "applies to all of the strains" mean that the anthrax vaccine has demonstrated efficacy in all, or even most, of the strains sufficient to satisfy federal regulatory requirements for licensure for the purpose of inhalation anthrax?
2. Has the anthrax vaccine been tested against all strains of the anthrax vaccine?
3. In which animals and how many strains were used on each animal, and against how many of the strains did the anthrax vaccine prove efficacious?
4. Is there a scientifically valid "correlate of immunity" in any of the animals in which the anthrax vaccine has demonstrated efficacy that is accepted by the FDA as a substitute for human efficacy studies required by federal regulations?

Who said it:

LTG Ronald Blanck, then-Army Surgeon General

Statement

Fact

Before the House Armed Services Committee on 30 Sep 1999:

Mr. GILMAN. "General Blanck, let me ask you another serious question. I understand that there are many, many strains of anthrax. Does this vaccine that you are using apply to all of the strains or just to one or two of the strains of anthrax?"

General BLANCK. "No, it applies to all of the strains."

1. See statements in the medical textbook "Vaccines" by the Army's chief anthrax researcher, Col. (Dr.) Arthur Friedlander, USA, and the author of the only peer-reviewed efficacy study of an anthrax vaccine by Dr. P.S. Brachman (although a different vaccine, it was used for the original approval of the current vaccine used in the AVIP):

• "The current vaccine against anthrax is unsatisfactory for several reasons…There is also evidence in rodents that the efficacy of the vaccine may be lower against some strains of anthrax than others."

• "There have been no controlled clinical trials in humans of the efficacy of the currently licensed U.S. vaccine. The vaccine has been extensively tested in animals…"

1. Statements undermine claims of efficacy in animal tests by Col. (Dr.) Arthur Friedlander, the Army's chief anthrax researcher. During internal DoD deliberations leading to the decision to implement the DoD anthrax vaccine program, he acknowledged that there are no scientifically valid "correlates of immunity" between animals used in Army testing, and humans. According to meeting minutes of a 20 Oct 1995 meeting to discuss obtaining FDA approval for an amendment to the FDA license for anthrax vaccine:

• "Col Friedlander discussed efforts at USAMRIID to develop in vitro correlates of immunity…The current thinking is that antibodies against "protective antigen (PA)" are important for immunity against anthrax infection. Yet, sensitive antigen-antibody assays, such as ELISA, fail to demonstrate a correlation between PA antibody levels and immunity."

• The same 20 Oct 1995 DoD meeting minutes go on to state:

"A serious complication in amending the license for anthrax vaccine is the lack of a suitable surrogate animal model; i.e. a model in which human immunity can be transferred directly and shown to be protective."

1. Further, US law (Food, Drug, and Cosmetic Act) does not allow the use of animal efficacy tests, even if scientifically valid, as a substitute for human efficacy tests required for vaccine licensure. Recognizing this, the FDA issued a Notice of Proposed Rulemaking on 5 Oct 1999 to allow the use of animal efficacy tests for biowarfare vaccines and drugs. The FDA has taken no further action on this proposal. Therefore, the repeated testimony by DoD and FDA representatives of the results of efficacy tests on guinea pigs, rabbits, and primates are legally irrelevant, because these tests cannot be used to fulfill regulatory requirements for amending the anthrax vaccine license to include an indication for inhalation anthrax.

Issue:

Genetically altered anthrax. Misrepresenting as "rumors" publicly reported statements regarding bioengineering of anthrax, which can be genetically altered to cause a degradation of the effectiveness of the anthrax vaccine.

Question(s):

Isn't it true that there have been published reports of bioengineering of anthrax in such a way that the current vaccine's effectiveness is really unknown?

Who said it:

LTG Ronald Blanck, then-Army Surgeon General

Statement

Fact

Before the Senate Armed Services Committee on 13 Apr 2000:

Gen Blanck: "Yes, we worry about the genetically engineered strains of bacteria that have been written about and talked about. We have not seen any, nor do we have access to any, so it is unknown as to whether our vaccine would protect against that..."

(later)

Sen. Warner: "To your knowledge, has any foreign nation or other group that we might have knowledge of manufactured anything that is beyond the strains that we have?

GEN. BLANCK: Nothing that I have knowledge of. We keep hearing rumors and we need to look into what the former Soviet Union has."

1. DoD concern about possible bioengineering to defeat the anthrax vaccine was one of the reasons for Secretary of the Army Louis Caldera to issue a letter indemnifying the anthrax vaccine manufacturer from liability on 3 Sep 1998. He stated in that letter:

"Moreover, there is no way to be certain that the pathogen used in tests measuring vaccine efficacy will be sufficiently similar to the

pathogen that U.S. forces might encounter to confer immunity."

2. Dr. Ken Alibek, former deputy director of the Soviet biological warfare directorate (BioPreparat), testified before the Joint Economic Committee of Congress on May 20, 1998:

"In the case of most military and all terrorist attacks with biological weapons, vaccines would be of little use. "

3. Dr. Alibek's rationale was explained in a New York Times article on 5 Apr 1998, in which he commented on Soviet efforts to genetically alter anthrax: "Moscow mastered the art of rearranging genes to make harmful microbes even more potent and harder to counteract. Anthrax, a top biological warfare agent that causes high fever and death, was genetically altered, he [Alibek] says, to resist five kinds of antibiotics." [Note: this is not equivalent to resistance to a vaccine.]
4. Contrary to LTG Blanck's assertion of "rumors", Russian scientists published an article about having genetically altered anthrax in the British medical journal "Vaccines" in Dec 1997. This was three months before DoD anthrax vaccinations began and two months before DoD's "independent expert", Dr. Gerard Burrow, submitted his review which endorsed DoD's plans to implement a mass vaccination program with the anthrax vaccine.

Issue:

Current anthrax vaccine "state of the art"? Misrepresenting to the Senate Armed Services Committee that the current anthrax vaccine is a state-of-the-art vaccine.

Question:

1. Is LTG Blanck's concurrence with Senator Warner's questioning as to whether the anthrax vaccine used by DoD is "state of the art" an accurate statement?
2. Is LTG Blanck's assertion that the current anthrax vaccine "will protect against all natural strains" substantiated by efficacy tests using all known strains on animals that the FDA has accepted as demonstrating a "correlate of immunity" in humans?
3. Isn't it true that the current anthrax vaccine's high adverse reaction rate has been known to DoD since before the Gulf War, and was reason for Bush Administration defense officials to characterize it as unsuitable for mass immunizations for this reason?
4. Is LTG Blanck's assertion that the anthrax vaccine being used on US servicemembers "meets all standards" substantiated by the anthrax vaccine manufacturer's record of repeated failed FDA inspections due to significant deviations from federal regulatory manufacturing standards substantiate?

Who said it:

LTG Ronald Blanck, then-Army Surgeon General

Statement

Fact

Before the Senate Armed Services Committee on 13 Apr 2000:

SEN. WARNER: "In my opening statement I carefully used the phrase, wrote it out myself, "state of the art," so that this vaccine meets state of the art knowledge on all strains, and it is your professional judgment that it will inoculate against them?"

GEN. BLANCK: "Yes, sir. This is a current vaccine, meets all the standards, it will protect against all natural strains. We are working, as Mr. Oliver has testified, on a new, even further advanced recombinant vaccine."

1. "Current" and "State of the art"
. DoD and the Army have long been aware of the anthrax vaccine's significant shortcomings.

• In a 24 Aug 1989 letter responding to questions by Senator John Glenn during a hearing, former Assistant Secretary of Defense Robert B. Barker stated the following:

"Current vaccines, particularly the anthrax vaccine, do not readily lend themselves to use in mass troop immunization for a variety of reasons: the requirement in many cases for multiple immunizations to accomplish

protective immunity, a higher than desirable rate of reactogenicity, and, in some cases, lack of strong enough efficacy against infection by the aerosol route of exposure."

• Col. (Dr.) Arthur Friedlander, the Army's chief anthrax researcher at Ft Detrick, MD, co-authored the chapter on anthrax vaccine in the medical textbook "Vaccines" in 1994 and again in 1999. In the article he critiqued the current anthrax vaccine as "unsatisfactory" because of high rates of adverse reactions and a multiple shot regimen.

• Col. (Dr.) Friedlander also acknowledged the anthrax vaccine's deficiencies during a meeting held by the Joint Program Office for Biological Defense on 20 Oct 1995.

1. "Meets all standards". The former and current anthrax vaccine production facility have failed FDA inspections with consistent "significant deviations" from manufacturing practices (CGMP) required by FDA regulations on the following inspection dates:

• May 4 - May 7, 1993
• May 31- June 3, 1994
• April 24 - May 5, 1995
• Nov 18 - Nov 27, 1997
• Feb 4 - Feb 20, 1998
• Nov 15 - Nov 23, 1999 (current facility)

The seriousness of these deficiencies was emphasized to the manufacturer (MBPI and Bioport) in:

• An FDA letter dated 22 Dec1993.

• An FDA Warning Letter dated 31 Aug 1995
• An FDA "Notice of Intent to Revoke" (NOIR) MBPI's license dated 11 Mar 1997

• An FDA inspection report finding "The manufacturing process for Anthrax Vaccine is not validated" dated 20 Feb 1998

• And another FDA letter with the same observation of Bioport's new production facility dated 23 Nov 1999.

Issue:

SecDef Cohen's 4 preconditions for implementing AVIP. Was the "independent expert" contracted by Undersecretary of Defense Rudy De Leon to review the medical aspects of the anthrax vaccine immunization program qualified to perform this review?

Question(s):

1. Why did the current Deputy Secretary of Defense, Mr. De Leon, select a professor of obstetrics and gynecology who has subsequently admitted in a letter to Congress to "no expertise in anthrax" to perform DoD's "independent review" of the AVIP?
2. Dr. Burrow stated in a 26 Apr 1999 letter to Rep Shays that he performed his "independent" review of the DoD anthrax vaccine program "out of patriotism." Was Dr. Burrow paid for his "independent review"? How much?
3. At the end of his 19 Feb 1998 report to then-Undersecretary of Defense Mr. De Leon, Dr. Burrow expressed gratitude to numerous DoD medical officials for their assistance. How does this reflect on the independence of Dr. Burrow's review?
4. Did Dr. Burrow provide subsequent assistance during implementation of the anthrax vaccine program, as he offered to Mr. De Leon in Feb 1998?

Who said it:

Dr. Gerard N. Burrow, M.D., DoD's "independent expert" hired to perform an independent review of the proposed anthrax vaccine immunization program.

Statement

Fact

"At your request, I have reviewed the Department of Defense plan to immunize the force against the biological warfare threat of anthrax. I have made several visits to the Pentagon, have had a number of telephone conferences and have consulted extensively with experts in allergy, immunology and infectious disease…"

"…The anthrax vaccine appears to be safe and offers the best available protection against wild-type anthrax as a biological warfare agent. Steps have been taken to ensure the safety and quality of the department's vaccine stockpile…."

"… I would like to thank Dr. Edward Martin for facilitating my access to information. I am particularly indebted to CAPT John Mateczun, MC, USN for his assistance and to the dedicated men and women in the various services who shared their knowledge with me. I hope this report is helpful to you and would be glad to provide assistance during implementation."

In a letter to Congressman Christopher Shays, 26 April 1999:

"The Defense Department was looking for some [sic] to review the program in general and make suggestions, and I accepted out of patriotism. I was very clear that I had no expertise in Anthrax and they were very clear they were looking for a general oversight of the vaccination program."

Note:

1. Dr. Burrow's observation
that "steps have been taken to ensure the safety and quality of the department's vaccine stockpile" is contradicted by the FDA inspection report on the Michigan Biologic Products Institute that was released the day after Dr. Burrow's 19 Feb 1998 positive review letter was submitted to DoD. The FDA's 20 Feb 1998 letter to MBPI was the result of a two-week inspection of the anthrax vaccine plant that preceded Dr. Burrow's review letter. The FDA letter stated: "The manufacturing process for Anthrax Vaccine is not validated", and listed dozens of separate deviations from FDA manufacturing standards.
2. Dr. Burrow declined an invitation to testify before Representative Shays' committee on 29 Apr 1999 to explain his "independent review" of the DoD anthrax vaccine program.

Issue:

The threat. Senior DoD officials misrepresenting the threat to Congress, servicemembers, and the American people

Question(s):

1. Why did Secretary of Defense Cohen claim that at least 25 countries had bioweapons in 1999, and then reduce that claim to only 10 nations in 2000?
2. Why does Secretary Cohen assert that "there is not a moment to lose" in preparing for a biowarfare attack when the number of countries he now claims (in 2000) to have these weapons is no different than DoD's position during the Reagan Administration?

Who said it:

Hon. William S. Cohen, Secretary of Defense

Statement

Fact

In an op-ed titled, "Preparing for a Grave New World", Washington Post, 26 July 1999:

• "At least 25 countries, including Iraq and North Korea, now have -- or are in the process of acquiring and developing -- weapons of mass destruction. Of particular concern is the possible persistence in some foreign military arsenals of smallpox...This is not hyperbole. It is reality...The race is on between our preparations and those of our adversaries. We are preparing for the possibility of a chemical or biological attack on American soil because we must. There is not a moment to lose."

(One year later….)

"At least 10 countries have or are developing anthrax as a weapon."

Testimony of Thomas J. Welch, Ph.D., Deputy Asst. to the Secretary of Defense for Chemical Matters, hearings before the Subcommittee on Oversight of Government Management, Committee on Government Affairs, US Senate, 28 July 1988:

• "...what has happened is that we have seen the number of nations possessing biological agents increase from 4 to 10 that we know of -- there are probably more -- and this drove us to approach the Armed Services Committee asking for increased funding for biological defense."

GAO report (after reviewing DoD's threat data), "Medical Readiness: Safety and Efficacy of the Anthrax Vaccine" (T-NSIAD-99-148), 29 Apr 1999:

• "The nature and magnitude of the military threat of biological warfare (BW) has not changed since 1990, both in terms of the number of countries suspected of developing BW capability, the types of BW agents they possess, and their ability to weaponize and deliver those BW agents..."

Dr. Jonathan Tucker, former UN biological weapons inspector in Iraq:

• "U.S. policy-makers and several outside analysts have predicted catastrophic consequences if a terrorist group or an individual-alone or with state sponsorship-ever mounts a major chemical or biological attack... But these scenarios have not drawn on a careful assessment of terrorist motivations and patterns of behavior... Contrary to the conventional wisdom about the catastrophic nature of chemical and biological terrorism, actual attacks were few in number, small in scale, and generally produced fewer casualties than conventional bombs."

Milton Leitenberg, senior fellow,
Center for International and Security Studies at the University of Maryland:

• "Nothing supports these propositions. They are exaggerated and alarmist. They are probably even dangerous and counterproductive, since they virtually solicit and induce precisely what they portray as fearing... The portrayal of this subject by senior government officials is grossly exaggerated, and the government's policy is accordingly based either on faulty assessments or no assessment at all."

Issue:

Coercion/Punishment for refusing the anthrax vaccine.

Question(s):

1. If anthrax vaccine is intended for the purpose of force protection, why have Guard commanders attempted to use it as a quid pro quo for training assignments in units which were not required under DoD guidance to be vaccinated?
2. Why has a general officer in the Indiana Air National Guard threatened a junior officer, in writing, with over 300 days in jail as punishment for failure to submit to the anthrax vaccine?

Who said it:

Mr. Charles Cragin, Principal Deputy Assistant Secretary of Defense for Reserve Affairs

*(Note: Mr. Cragin was named as an acting assistant secretary of defense for reserve affairs during the 105^th Congress. This title lapsed after the White House declined to nominate Mr. Cragin for Senate confirmation.)

Statement

Fact

"If someone is going to resign, Mr. Shays, they are certainly not going to be subject to any penalties. That is one of the points of the Guard and Reserve."

1. Air Force Reserve
. Guidance to commanders directed them not to allow transfers of USAF Reserve personnel to non-mobility positions in the reserves unless the reservists submitted to being vaccinated, even though their new positions did not require the anthrax vaccine.
2. Maryland Air National Guard
. An Air National Guard general officer attempted to use the anthrax vaccine as a quid pro quo for training, even when the unit was not an AVIP Phase I unit requiring the vaccine.
3. Kansas Air National Guard
. Four days after Mr. Cragin's testimony, the commander of the 184th Bomb Wing, Kansas Air National Guard, issued a written warning to a B-1 bomber pilot, threatening a $500 fine and six months in jail because the pilot had asked to transfer to a non-mobility position in lieu of submitting to the vaccine.
4. Indiana Air National Guard
. At least one pilot has been threatened in writing, although half (15) of the pilots in the unit left.

• On 24 June 2000 a captain in the Ft. Wayne F-16 squadron who had refused the anthrax vaccine was issued a letter from a general officer which stated:

"1. You are reprimanded 2. You are fined 2/3 of 1 month's base pay; however, the fine is suspended upon the condition that you submit to Anthrax Vaccination within 30 days of imposition of punishment."

• When that officer declined to be vaccinated, he was sent another letter 20 Aug 2000 from a different general officer which stated:

"I have determined that you violated... the condition of the suspension of your punishment.... I have determined that you did not take the anthrax vaccine on or before 24 July 2000.... If you do not pay the fine voluntarily, then you will be committed to the Allen County Jail until such fine is paid or until one day shall be served for each one dollar of the fine."

1. Michigan Air National Guard
. An A-10 pilot was removed from flying status in June 2000 for refusing to take the anthrax vaccine. The unit leadership attempted to separate this officer with an other than honorable discharge -- without ever charging him with an offense. On 4 Aug 2000 this pilot was sent a letter from his unit commander which informed him he would be separated honorably because "apparently, the JAG, Capt Niedergall says that legally we cannot offer you a General / Administrative discharge…" This officer has been thrown out of the Air National Guard without a single charge ever being proffered against him.
2. Air Force Reserve
. When the DoD anthrax vaccine policy changed in July 2000 to a 30-day in-theater requirement, an Air Force Reserve officer who had left his unit in 1999 applied to rejoin his C-5 transport unit at Travis AFB, the 301st Airlift Wing. He informed the On 24 Sep 2000 the Air Force Reserve the lieutenant colonel met a board comprised of the wing commander and two other senior officers to determine whether he would be allowed to rejoin his unit. The board lasted just a few minutes, ending when the wing commander told the officer that he would have to submit to the anthrax vaccine as a quid pro quo for rejoining the unit.

Issue:

Compliance with shot protocol in FDA license. Misrepresenting DoD's intention to follow the FDA licensed shot protocol.

Question(s):

1. Last September Mr. Cragin testified that DoD was adhering to the licensed six shot protocol to the "greatest extent possible". Does Mr. Cragin consider DoD to be adhering to that standard by initiating shots when it was clear the AVIP program would run short of vaccine due to the FDA declining to certify the manufacturer?
2. Last summer Army ROTC cadets were given twice the normal dose of anthrax vaccine prior to deploying to South Korea for their summer training.

-- Does Mr. Cragin considers this to be an example of adhering to the FDA shot protocol?

-- Why was DoD sending untrained ROTC cadets who could serve no useful combat role to a so-called high-threat area? Does this mean South Korea is actually not a high-threat area? Is this why the South Korean military does not vaccinate its troops for anthrax?

3. When DoD ran short of vaccine this past summer they quickly referenced a CDC panel's (Advisory Committee on Immunization Practices) approval of a deviation from the FDA licensed shot protocol. Does seeking an outside endorsement of this deviation represent adhering to the FDA shot protocol "to the greatest extent possible"?
4. The committee has been advised that the Massachusetts Air National Guard F-15 unit at Otis Air Force Base is about to deploy to Southwest Asia, and they received only one anthrax shot last spring -- well before Secretary Cohen's July curtailment announcement. Does this action represent adhering to the FDA shot protocol "to the greatest extent possible"?

Who said it:

Mr. Charles Cragin, Principal Deputy Assistant Secretary of Defense for Reserve Affairs

*(Note: Mr Cragin was named as an acting assistant secretary of defense for reserve affairs during the 105^th Congress. This title lapsed after the White House declined to nominate Mr. Cragin for Senate confirmation.)

Statement

Fact

Mr. Shays. "So you are abiding by the FDA's [6 shot] protocol?"

Mr. Cragin. "We are abiding by the FDA protocol to the greatest extent possible in inoculating this force."

The military has deviated from the protocol by:

1. The non-compliance with the FDA-licensed shot protocol has been egregious. For instance, in Sep 1999 the CT ANG was in 90% non-compliance with FDA-licensed shot protocol.
2. Continuing to start the shots when they knew that six shots could not be administered. Because of a predictable shortage of vaccine that was the result of FDA declining to certify the new anthrax vaccine facility, over 500,000 servicemembers are, or will soon be, in non-compliance with the FDA licensed protocol.
3. Unilaterally establishing a +/- 30-day criteria for compliance with the shot timeline that allows for large deviation from the FDA licensed protocol. (i.e. a 2^nd shot scheduled for day 14 could be administered at day 44 and DoD will report it as "on schedule.")
4. Vaccinating ROTC cadets who were unnecessarily deployed to a "high-risk" area for only 2-4 weeks, and then returned to civilian colleges where their vaccination schedule would lapse.

Issue:

The biowarfare threat. Misrepresenting the threat and the historical context of the anthrax vaccine immunization program to Congress.

Question(s):

1. Does the British military find the Boer War example you cited in your 16 May 2000 letter to Congress compelling enough to mandate anthrax vaccinations for their military?
2. Do any U.S. allies in those countries DoD designates as "high-threat" areas -- for instance, South Korea and Israel -- mandate the anthrax vaccine for their military servicemembers?
3. Do any other U.S. allies mandate the anthrax vaccine for their military servicemembers?

Who said it:

Mr. Charles Cragin, Principal Deputy Assistant Secretary of Defense for Reserve Affairs

*(Note: Mr Cragin was named as an acting assistant secretary of defense for reserve affairs during the 105^th Congress. This title lapsed after the White House declined to nominate Mr. Cragin for Senate confirmation.)

Statement

Fact

Responding on behalf of Secretary of Defense William Cohen in a letter to 35 members of Congressmen, 16 May 2000:

"…In closing, let me share a true story from an earlier era. In 1898, the British were preparing to fight the Boer War. Their senior leadership considered giving all their troops the recently approved Typhoid Vaccine. Opposition arose, some protests were held, some in their Parliament objected, and that vaccine was made voluntary. Fourteen thousand troops elected to take the shot. The troops went to war and 59,000 came down with typhoid. Nine thousand of them died while a perfectly safe and effective vaccine remained on the shelf. We cannot allow the last chapter of the anthrax story to be a BOER War analogy!"

1. Apples vs. Oranges
. Mr. Cragin compares vaccination against a common natural health risk (typhoid) with vaccination against a biological warfare agent (weaponized anthrax). Naturally occurring anthrax is not a health risk to U.S. forces.
2. United Kingdom
. The anthrax vaccination program in the British military is voluntary, and over 70% of British servicemembers choose not to be vaccinated. Clearly, the Boer War example cited by Mr. Cragin is not compelling to the British government or their military leadership.
3. Canada
. In May 2000, the Canadian military suspended court-martial charges against a Canadian Air Force career servicemember who had refused the anthrax vaccine. Canada's chief military judge stated the anthrax vaccine was:

"…unsafe and hazardous and could be responsible for the important symptoms reported by so many persons who took that vaccine."

4. France
. In Sep 2000 the French ministry of defense announced the creation of an independent commission that will look into the health of French military servicemembers who served in the Gulf War attached to US forces. A physician spokesman for the French military reiterated that:

"…France's belief that allied troops were victims of their own protective measures were based on a long series of meetings with U.S. medical experts."

The French military physician noted that while about 16% of US Gulf War veterans have complained of ailments associated with Gulf War syndrome, less than 1% of French troops had similar symptoms. The French did not use the anthrax vaccine, but will study whether their servicemembers stationed with US forces took the vaccine and other biowarfare drugs.

5. South Korea
. Does not use the anthrax vaccine, despite being labeled by DoD as a so-called "high-threat" area and DoD efforts to convince them to use it.
6. Israel
. Does not use the anthrax vaccine, despite being labeled by DoD as a so-called "high-threat" area.
7. Other U.S. NATO or non-NATO allies
. None uses the anthrax vaccine.

Issue:

Endorsements of anthrax vaccine. Misrepresenting to Congress that the American Public Health Association supports the DoD anthrax vaccine policy.

Question(s):

Why did Mr. Cragin use a medical reference book to convince Congress that the American Public Health Association supports DoD's use of the anthrax vaccine instead of confirming the Association's stance by contacting them directly (or referencing their website)?

Who said it:

Mr. Charles Cragin, Principal Deputy Assistant Secretary of Defense for Reserve Affairs

*(Note: Mr Cragin was named as an acting assistant secretary of defense for reserve affairs during the 105^th Congress. This title lapsed after the White House declined to nominate Mr. Cragin for Senate confirmation.)

Statement

Fact

Responding on behalf of Secretary of Defense Cohen in a 16 May 2000 letter to 35 bipartisan Members of Congress:

"Comment -- A reading of that association's 17th Edition of the American Public Health Association's Control of Communicable Diseases Manual (James Chin, MD, MPH editor) specifies a preventive measure for exposure to anthrax is to "immunize high risk persons with a cell-free vaccine prepared from a culture filtrate containing protective antigen. Evidence indicates that this vaccine is effective in preventing cutaneous and inhalational anthrax; it is recommended for laboratory workers who routinely work with B anthrax and workers who handle potentially contaminated industrial raw materials. It may also be used to protect military personnel against potential exposure to anthrax as a biological warfare agent. Annual booster injections are recommended if the risk of exposure continues."

1. Policy Statement #9930 adopted by the Governing Council of the American Public Health Association, November 10, 1999:

• Urges the US Department of Defense to delay any further immunization against anthrax using the current vaccine
or at least to make immunization voluntary; and

• Urges that a commission of military and non-military public health experts be formed to review the evidence for effectiveness and safety of the current vaccine and the time at which an improved vaccine may be available, and to make recommendations about the continuation of the current immunization program.

1. Mohammed N. Akhter, MD, MPH, Executive Director, American Public Health Association, in a 23 May 2000 letter to Congressman Jack Metcalf reiterating the APHA's policy statement on the anthrax vaccine:

• "This policy statement is based upon the controversy in the medical literature about the efficacy of the vaccine; the lack of valid monitoring of its potential adverse effects; and the stance taken by the United Kingdom and other allies that the receipt of the vaccine remain voluntary among their troops."

Issue:

Retention and recruiting impact of AVIP. Misrepresenting to the House Government Reform Committee the retention impact of the anthrax vaccine program on the Guard and Reserve.

Question(s):

1. Just days after Mr. Cragin testified before Rep Shays' subcommittee on September 29, 1999, 60 servicemembers, including 22 pilots left the Tennessee Air National Guard C-141 unit in Memphis over the anthrax vaccine. Does he view this as "no appreciable impact" when it costs $6 million to train a new military aviator and all of the military pilot production pipelines are already operating at full capacity?
2. Fifteen (15) pilots in an Indiana Air National Guard F-16 unit -- one-half of the unit's pilots -- left the Guard over the anthrax vaccine last February. That is $90 million worth of pilots in one fighter squadron, and many years of experience. Does he view this as having "no appreciable impact" on readiness?

Who said it:

Mr. Charles Cragin, Principal Deputy Assistant Secretary of Defense for Reserve Affairs

*(Note: Mr Cragin was named as an acting assistant secretary of defense for reserve affairs during the 105^th Congress. This title lapsed after the White House declined for undisclosed reasons to nominate Mr. Cragin for Senate confirmation.)

Statement

Fact

Mr. Charles Cragin, testimony before National Security Subcommittee of the House Government Reform Committee, 29 Sep 1999:

"We should not look to a single-factor explanation, such as concern about anthrax vaccinations, to account for the decline in recruiting and retention that has generally characterized the Total Force in recent years. According to the Chiefs of the Reserve components, recent recruiting and retention trends do not show any substantial increase or decrease attributable to the anthrax vaccination program. And although the military recruiting market has posed significant challenges to all Services, both active and reserve, in the past few years, we currently see no appreciable impact as a result of implementation of the anthrax vaccination program."

1. Two weeks prior to testifying, Mr. Cragin had direct, personal knowledge of attrition in air reserve component units. He was briefed on 15 Sep 1999 that the NYANG C-5 unit would be only 57% manned with pilots if mandatory vaccinations scheduled for that month took place. Cragin later acknowledged this in an exchange of letters with Rep Christopher Shays. However, in that letter Mr. Cragin repeated an assertion by the unit commander that losing over 40% of its pilots would leave readiness in that unit at "acceptable levels".
2. According to anecdotal reports received by the House Government Reform Committee from Reserve officers, over 240 pilots left just the first 5% of Air National Guard and USAF Reserve units that forced their personnel to take the anthrax vaccine. The cost to taxpayers for replacing these experienced pilots is nearly $1.5 billion. The rate of attrition has slowed coincident with the delay of mandatory vaccinations at other Reserve Component units caused by the vaccine shortage brought about by the manufacturer's in ability to obtain FDA certification.
3. Reserve attrition
. As of early 2000, published media reports of pilot attrition in Reserve Component units subsequent to mandatory anthrax vaccinations being imposed was:

• 7 of 30 pilots assigned to the 115^th Fighter Wing, WI ANG.

• 8 pilots, pilots assigned to the 103^rd Fighter Wing, CT ANG.

• 17 pilots assigned to the 79^th Air Refueling Squadron, USAF Reserve, Travis AFB, CA.

• 30 of 58 pilots assigned to the 97^th Airlift Squadron, USAF Reserve, McChord AFB, WA.

• 20 pilots assigned to the 514 Air Mobility Wing (USAF Reserve) or 108^th Air Refueling Wing (NJ ANG). McGuire AFB, NJ.

• 22 of 50 pilots, plus 38 additional non-pilot personnel, assigned to the 164^th Airlift Wing, TN ANG.

• At least 12 of 34 F-16 pilots in the 122^nd Fighter Wing, IN ANG.

1. Active duty attrition
. Losses have also occurred in active duty units, where the personal cost of refusal is much higher, often a court-martial:

• In the active duty Marine Corps, there have been two dozen (24) Marines on Okinawa, 30 more at Camp Pendleton, CA, and 10 at Twenty-Nine Palms, CA -- with several being court-martialed, jailed, and given bad conduct discharges.

• In the active duty Navy 29 active duty sailors on the aircraft carrier USS Theodore Roosevelt, 7 sailors on the carrier USS John C. Stennis, and 7 more on the carrier USS Independence.

• The Air Force has court-martialed or discharged servicemembers at:

-- Dover AFB, DE

-- Andrews AFB, MD

-- Offut AFB, NE

-- Travis AFB, CA

1. The Army has given less than honorable of general discharges to servicemembers, but usually without court-martial. However, a court-martial of an active duty soldier at Ft. Hood, TX, is scheduled to begin on 11 Oct 2000.
2. The New York Times reported on 28 Aug 2000 that Army, Navy, and Air Force reserve components would fail to meet their recruiting goals (this was not attributed to anthrax in article.)
3. To stem continuing attrition in Air National Guard units, the Director of the Air National Guard has initiated a study of how to provide childcare for Air National Guard personnel while they are on duty.

Issue:

Retention. Misrepresenting to the House Government Reform Committee that DoD would make an effort to ascertain the retention impact of the anthrax vaccine immunization program (AVIP).

Question(s):

Why doesn't the current DoD survey of Reserve Component military personnel include any questions about the impact of the anthrax vaccine on the morale and retention of reserve component personnel?

Who said it:

Mr. Charles Cragin, Principal Deputy Assistant Secretary of Defense for Reserve Affairs

*(Note: Mr Cragin was named as an acting assistant secretary of defense for reserve affairs during the 105^th Congress. This title lapsed after the White House declined to nominate Mr. Cragin for Senate confirmation.)

Statement

Fact

In testimony before National Security Subcommittee of the House Government Reform Committee, 29 Sep 1999:

Rep. Shays: " First off, I make an assumption that you are intending to measure AVIP impact on readiness or retention. Should I make that assumption?"

Mr. Cragin: "...So I think it stands to reason that medical readiness from that perspective would be looked at, yes sir."

Rep. Shays: "And also retention."

Mr. Cragin: "We would look at retention and a number of issues. Readiness certainly is affected by retention. There is not question about that."

The Reserve Components for which Mr. Cragin is responsible are currently conducting a survey of both federal Reserve and National Guard personnel.

• The survey does not address the anthrax vaccination program.

• In the survey the anthrax immunization vaccination program (AVIP) is not included as a reason for leaving the reserve components or as a morale issue.

Issue:

SecDef Cohen's 4 preconditions for implementing AVIP. Did Undersecretary of Defense Rudy De Leon insure that the "independent expert" he contracted to review the medical aspects of the anthrax vaccine immunization program had access to relevant information regarding the manufacturer's failure of an FDA inspection that occurred concurrent with the "independent expert's" review?

Question(s):

1. Why did Mr. De Leon incorrectly claim to U.S. troops in April 1998 that DoD's "independent expert" contracted to review DoD's planned anthrax vaccination program, Dr. Burrow, was the Dean of the Yale Medical School?
2. DoD's independent expert, Dr. Burrow, submitted his review approving the DoD anthrax vaccine program on 19 Feb 1998. Did Mr. de Leon and his staff insure that their "independent expert", Dr. Burrow, was aware of an FDA inspection of the anthrax vaccine manufacturer that occurred between 4-19 Feb 1998, which concluded in a report "The manufacturing process for Anthrax Vaccine is not validated"?
3. Why did Mr. de Leon and his staff charge Dr. Burrow with insuring "the safety and efficacy of the Department's vaccine stockpile", and then accept a review in which Dr. Burrow had commented favorably about the "integrity of the system" to review the vaccine stockpile, despite having never reviewed the results of the supplemental testing ordered by the Secretary of Defense?
4. Why did Mr. de Leon charge Dr. Burrow with insuring "the safety and efficacy of the Department's vaccine stockpile", and then accept a review in which Dr. Burrow failed to mention, or discuss, the reasons for the FDA-mandated quarantine of 11 of 40 lots of anthrax vaccine which occurred during his review?

Who said it:

Hon. Rudy de Leon, then-Undersecretary of Defense for Personnel and Readiness (now Deputy Secretary of Defense)

Statement

Fact

"De Leon said it is safe and effective, and has been in use for years. "We asked an outside expert panel, led by the dean of the medical school at Yale University, to take a fresh look at the vaccine," De Leon said. They certified the program as safe, he said."

From Dr. Burrow's report to Undersecretary of Defense De Leon, 19 Feb 1998:

"The Safety and Efficacy of the Department’s Stockpile- The vaccine has been approved by the FDA, and there are an adequate number of doses in the current anthrax vaccine stock pile. As directed by DOD, a supplemental testing program started in January 1998 and all batches are scheduled to be tested by November 1998. The decision to perform supplemental tests was based on a March 11, 1997 letter to MBPI from FDA, outlining a number of systemic issues. The FDA directed MBPI to do a comprehensive review to demonstrate that deviations in biologic product lines did not impact anthrax vaccine quality and integrity. These results of this review should be available in the near future. There appear to be procedures in place to assure the integrity of the system."

1. In testimony before the Senate Armed Service Committee on 12 Jul 2000, FDA's director of the Center for Biologics Evaluation and Research, Dr. Kathryn Zoon, acknowledged:

"The February [1998] inspection, as stated, disclosed many significant deviations to FDA regulations. In addition, the inspection resulted in the request by FDA that Michigan quarantine 11 lots of anthrax vaccine held in storage pending review of additional information to be submitted by Michigan regarding the lack of investigations into possible problems with potency sterility in particulate matter."

This FDA-ordered quarantine occurred prior to the submission of the report by Dr. Burrow, DoD's "independent expert.", Dr. Burrow asserted in his report that, "there appear to be procedures in place to assure the integrity of the [stockpile] system."

Significantly, DoD representatives were aware of the quarantine and were allowed to participate in conference calls between the manufacturer and the FDA. It is unclear whether they ever informed their "independent expert" of the lot quarantine or of the "significant deviations" from manufacturing practices mandated in federal law found during FDA's 4-19 Feb 1998 inspection of the manufacturer.

2. Based on statements in his report to Mr. de Leon, it appears that Dr. Burrow relied on DoD to provide him with the information necessary to determine the safety and efficacy of the anthrax vaccine in general, and the existing stockpile, in particular:

"… I would like to thank Dr. Edward Martin [deputy Assistant Secretary of Defense for Health Affairs] for facilitating my access to information. I am particularly indebted to CAPT John Mateczun, MC, USN for his assistance and to the dedicated men and women in the various services who shared their knowledge with me. I hope this report is helpful to you and would be glad to provide assistance during implementation."

Issue:

Allied/Non-U.S. use of the anthrax vaccine. Misrepresenting to Congress the use of the anthrax vaccine by a U.S. ally.

Question(s):

Why did Mr. de Leon imply to the Senate Armed Services Committee that the British were using the anthrax vaccine when the British vaccine policy is voluntary and over 70% of their servicemembers do not submit to the vaccine?

Who said it:

Hon. Rudy de Leon, then-Undersecretary of Defense for Personnel and Readiness (now Deputy Secretary of Defense)

Statement

Fact

In testimony before the Senate Armed Services Committee, 12 Jul 2000:

SEN. WARNER Quickly, other nations, how are they facing this threat? I mean, it knows no boundaries in terms of military forces. most of our operations today are joint operations with our principal allies. What are they doing, Mr. Secretary?

MR. DE LEON: The British are immunizing their forces. They, too, have gotten in the same bind that we are in.

SEN. WARNER: I understand they have had to suspend their source.

MR. DE LEON: Right. This is not a high profit market, and so --

SEN. WARNER: We understand that, but in other words our allies only one ally so far, you mentioned.

MR. DE LEON: The British.

SEN. WARNER: -- encountering the same problems.

MR. DE LEON: Correct.

1. United Kingdom
. The anthrax vaccination program in the British military is voluntary, and over 70% of British servicemembers choose not to be vaccinated.
2. Canada
. In May 2000, the Canadian military suspended court-martial charges against a Canadian Air Force career servicemember who had refused the anthrax vaccine. Canada's chief military judge stated the anthrax vaccine was:

"…unsafe and hazardous and could be responsible for the important symptoms reported by so many persons who took that vaccine."

3. France
. In Sep 2000 the French ministry of defense announced the creation of an independent commission that will look into the health of French military servicemembers who served in the Gulf War attached to US forces. A physician spokesman for the French military reiterated that:

"…France's belief that allied troops were victims of their own protective measures were based on a long series of meetings with U.S. medical experts."

The French military physician noted that while about 16% of US Gulf War veterans have complained of ailments associated with Gulf War syndrome, less than 1% of French troops had similar symptoms. The French did not use the anthrax vaccine, but will study whether their servicemembers stationed with US forces took the vaccine and other biowarfare drugs.

4. South Korea
. Does not use the anthrax vaccine, despite being labeled by DoD as a so-called "high-threat" area and DoD efforts to convince them to use it.
5. Israel
. Does not use the anthrax vaccine, despite being labeled by DoD as a so-called "high-threat" area.
6. Other U.S. NATO or non-NATO allies
. None uses the anthrax vaccine.

Issue:

Safety of the anthrax vaccine. Misrepresenting to medical professionals in the Journal of the American Medical Association, that credible studies have proven the anthrax vaccine to be safe.

Question(s):

1. Why didn't Col Friedlander inform fellow medical professionals that there were no long-term studies of the anthrax vaccine's safety in the article he wrote in the Journal of the American Medical Association in Dec 1999?
2. Isn't it misleading for Dr. Friedlander to state in a medical journal that there is no evidence of adverse health effects from the anthrax vaccine when, as the Institute of Medicine reported last March, there have been no peer-reviewed long-term studies of the vaccine?
3. Why didn't Col Friedlander identify himself as a colonel in the U.S. Army in the byline of the article he wrote in the Journal of the American Medical Association in Dec 1999?
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