1. Purpose: To inform senior policy makers on the DOD’s mandatory Anthrax Vaccination Immunization Program (AVIP), and its implications on the readiness and morale of the military.
2. Background: In Dec 1997 SECDEF Cohen announced the AVIP program ostensibly due to perceived increase in threat from rogue states (Iraq, North Korea, etc.) and terrorists. (1) He mandated four conditions be met prior to start of the program. Hundreds of Servicemembers have since refused the vaccine – and have been subjected to various levels of military discipline. DOD asserts the vaccine is "safe, effective and FDA-approved." Vaccination refusals in the reserve components became public in Jan 1999 when eight officers (fighter pilots) in the Connecticut Air National Guard were forced to resign from their unit after they declined to be vaccinated. (2) The House Committee on Government Reform (Rep Shays R-CT) conducted hearings in Mar (3), Apr 1999 (4), June and July on the safety, efficacy, and necessity of the vaccine. Separately, in late Mar 1998 the GAO issued a study calling for a DOD-funded study on the presence of antibodies to squalene (an experimental, non-approved vaccine booster) in the blood of Gulf War Illness veterans. (5) A week later Vanity Fair (6) and Insight Magazine (7) reported on the possibility that in 1991 DOD had funded the development of anthrax vaccine using the experimental booster (adjuvant) squalene instead of the approved booster alum. DOD categorically denies producing a squalene based anthrax vaccine, although it admits funding human vaccine studies using squalene since 1988. (8) Rep Metcalf (9) (R-WA), Rep Mica (R-FL), and Rep Jones (10) (R-NC) have called for hearings by the House Armed Services Committee to investigate whether DOD produced and used experimental anthrax vaccine on soldiers. SECDEF Cohen recently stated, "I would be derelict in my duties" if he did not mandate the anthrax vaccine. (11)
3. Discussion:
   • Program: The AVIP will inoculate all 2.4 million active, Guard and Reserve servicemembers by 2003. (12) To date, about 10% of US military personnel have begun the six-shot vaccination series that lasts over 18 months, followed by annual boosters. (13)
   • Issue #1: Safety: DOD maintains vaccine is safe. (14) Congressional hearings reveal higher adverse reactions than other vaccines. Consistent DOD claims of widespread use by veterinarians were dispelled as false, forcing DOD to modify an information brochure given to personnel when vaccinated. (15)
   • Issue #2: Efficacy: DOD maintains vaccine is effective. Inhalation tests on animals beginning in late 1960’s indicate a myriad of results from a vaccine developed for topical (skin) anthrax infection. GAO states these studies, while showing some positive results, may not be extrapolated to humans. (16)
   • Issue #3: Necessity: DOD maintains vaccine is necessary. International consensus -- Article 5 of the Washington Treaty of 1922, the Geneva Protocols, and the Hague Conventions – provide basis for rejection of chemical and biological warfare by international community. Vaccination program may advertise new US acceptance that use of these weapons is inevitable – this is a significant doctrinal shift from US posture during the Gulf War. (17) The Foreign Policy Journal’s fall ’98 edition offered a more traditionally accepted doctrine of international deterrence: "The United States must relay a stern, yet discreet message to states that continue to support or conveniently disregard terrorist organizations within their territory. Any use of weapons of mass destruction by their clients against the United States will constitute just cause for massive retaliation, whether or not evidence proves for certain that they ordered the attack." (18)
   • Flawed SECDEF-mandated pre-AVIP review: DOD asked Dr. Gerard Burrow, an obstetrics and gynecology specialist from Yale University, who has acknowledged "no expertise in anthrax" to review the AVIP. (19) DOD has since repeatedly used his "approval" as justification to continue the AVIP. (20) Also, the sole producer of the vaccine, threatened by FDA in 1997 with revocation of their license, was allowed to test their own vaccine’s quality, potency, and sterility. In April 1999 testimony, the anthrax vaccine program manager, BG Eddie Cain, admitted to "inconsistencies" in the supplemental testing procedure. He stated: "based on this inconsistency, JPOBD suspended supplemental testing and sent a "Tiger Team" of subject matter experts to help resolve the problem. Corrective action is being implemented. We expect to resume testing within six months." This admission of "inconsistencies" by DOD’s program managers means that the supplemental testing performed on anthrax vaccine used on Servicemembers is of questionable value. Additionally, on 29 Apr 99 the GAO reported to Congress that anthrax vaccine "quality cannot be guaranteed from final tests on random samples but only from a combination of in- process tests, end- product tests, and strict controls of the entire manufacturing process." Therefore, supplemental testing, even if without "inconsistencies" admitted to by DOD, cannot compensate for a flawed manufacturing process revealed by FDA inspections and documented by the GAO.
   • DOD tactics: Use of Uniform Code of Military Justice (UCMJ) to punish refusers. Ridicule those who oppose the program – Commandant of Marine Corps quoted stating that refusers" are petrified that their penis is going to fall off." (21) Branding refusers as unwilling to deploy to Gulf, leaving for family or employer pressures, despite exemplary records. (22) Claims of Internet misinformation (23) to generalize those opposed to AVIP as a fringe element.
   • Potential costly retention issue: Personnel from all services are leaving instead of risking their health to a suspect vaccine. Many service members who have received the vaccine are not happy or eager to comply with the program, believe they have no choice, and faith in their commanders is lost. (24) In the Guard and Reserve the UCMJ is not a threat – resignations are allowed resulting in loss of highly trained personnel. May become costly irritant that exacerbates existing retention problems.
   • Possible Gulf War Illness connection: Mar 1999 GAO report, Vanity Fair and Insight Magazine articles highlighted independent research results showing presence of antibodies to experimental vaccine booster (adjuvant) squalene in small sample of GWI victims. Implication is that DOD may have produced and used an experimental anthrax vaccine in 1991 that may still be in vaccine stocks. DOD categorically denies. GAO called for DOD-funded study on squalene antibodies in GWI victims, which DOD rejects.
4. Conclusion: Safety and efficacy of anthrax vaccine are in question. Congressmen are asking why a decades-old vaccine is now necessary against a threat that has existed even longer. SECDEF-mandated review of vaccine by a non-expert was cursory. DOD has used inaccurate information to convince military personnel of vaccine’s safety and the UCMJ to intimidate those opposed to program. Possible link between Gulf War Illness and anthrax vaccine exists.
5. Recommendation: DOD should terminate the mandatory anthrax vaccinations pending an impartial review of the safety, efficacy, and doctrinal necessity of the AVIP.

Chronology

• 1990-1991 – Approximately 150,000 (25) of over one half million military personnel involved in the Gulf War are vaccinated for anthrax, including some who do not deploy to Southwest Asia. Vaccinations stop after Gulf War ends and do not resume again until March 1998.
• Feb 1993 – World Trade Center is bombed with conventional explosive.
• Mar 1995 – Japanese cult uses Sarin gas and botulinum toxin in Tokyo subway attack. Same group attempted to use anthrax in an ineffective attack in June 1993. (26)
• Apr 1995 – Oklahoma City federal building is bombed with conventional explosive
• Jun 1995 – President Clinton issues Presidential Decision Directive PDD-39, outlining U.S. counter-terrorism strategy to consist of three main elements: 1 -- Reduce vulnerabilities and prevent and deter terrorist acts before they occur. 2 -- Respond to terrorist acts that do occur, including managing crises and apprehending and punishing terrorist perpetrators. 3 -- Manage the consequences of terrorist attacks. (27)
• 1996 – Nunn-Lugar-Domineci legislation passes Congress mandating DOD responsibility to train first-responders for domestic terrorism response.
• 1997-1999 – At his Jan 1997 Senate confirmation testimony SECDEF Cohen began his term by emphasizing one of his major concerns: "The proliferation of weapons of mass destruction threaten our interests, our forces and even our homeland." (28) He has given numerous speeches referencing the threat from biological weapons, including anthrax. (29)
• Mar 1997 – FDA threatens to revoke the license of the sole anthrax production facility due to numerous quality control deficiencies. (30) This followed a previous warning letter issued by FDA in Aug 1995 (31) and deficiencies noted by DOD during a March 1992 inspection. (32) The State of Michigan later sold the plant to a new private firm called Bioport, Inc.
• 1 May 1997 – DOD issues report to Congress: "Domestic Preparedness Program in the Defense Against Weapons of Mass Destruction." (33) Report responds to 1996 Nunn-Lugar-Domenici legislation requiring DOD to train WMD first-responders for domestic terrorism. (34) Report noted that officials from four major cities had told FEMA: "Beyond technical experts, personnel resources would be required by local governments to assist with the potentially massive public impacts of such incidents - whether it be mass casualties or large-scale evacuation." (35)
• 31 Jul 1997 – SECDEF Cohen effectively ends the career of USAF BGen Schwalier for inadequate force protection measures related to the Khobar Towers bombing in Saudi Arabia. Cohen stated: "The bombing of Khobar Towers Housing Complex in Saudi Arabia last year highlighted the threat of terrorism that our military faces around the world and the requirement for effective force protection. My own assessment is that we need to have one standard, and everybody has to understand what force protection means and be trained appropriately and be held accountable under those circumstances." (36)
• Nov 1997 – Forces deploy to the Persian Gulf in order to react to the refusal of Iraqi regime to comply with UN monitoring and inspection teams. Force protection questions evolve with respect to Iraqi biological warfare threat to US forces in region and US vulnerability to weapons of mass destruction. (37)
• Dec 1997 – SECDEF Cohen announces the Anthrax Vaccine Immunization Program (AVIP). Press release asserts that the anthrax vaccine is "widely used" by veterinarians, a statement later repeated at virtually every Pentagon press conference on anthrax and in a brochure given to troops. (38) Over a year later DOD is forced to change the brochures because information regarding usage by veterinarians was incorrect. (39) DOD mandates a four-point review of the vaccine before program begins (each pre-requisite is now in question):
  • Supplemental testing, consistent with Food and Drug Administration standards, to assure sterility, safety, potency and purity of the vaccine. (Suspended by the DOD, see endnote #45)
  • Implementation of a system for fully tracking personnel who receive the anthrax vaccinations. (Criticized by 29 April 1999 Congressional hearings as "passive", see endnote #77)
  • Approval of appropriate operational plans to administer the immunizations and communications plans to inform military personnel of the overall program. (Communications to military personnel contained factually incorrect information that DOD has been forced to correct, see endnote # 39)
  • Review of health and medical issues of the program by an independent expert. (Dr. Burrow admits he has no expertise in anthrax, see endnote #42)
• Dec 1997 – RADM Cowan, Joint Staff J-4, attends a DOD press background briefing the day AVIP is announced. He states: "This is a force protection issue…It fits with our strategic concepts." He also says that there are 1.2 million troop-equivalent doses (six shots each) of vaccine stockpiled and claims that DOD had found no impurities in the stockpile. (40) Later testing proves this incorrect. When asked whether the AVIP is another step in a biological arms race RADM Cowan states: "I don't know. It could be, but I'm not prepared to answer that."
• Feb 1998-Apr 1999 – Dr. Gerard Burrow, Yale OB/GYN, writes a letter dated 19 Feb 1998 approving the AVIP program. (41) He releases his report to DOD on 2 Mar 1998. In the letter he thanks personnel at the Pentagon and within the DOD for their assistance in conducting his review. In a 26 Apr 1999 letter Dr. Burrow responded to requests by Congressman Shay’s Committee to testify about his expertise in anthrax. It included the following statement in a letter in lieu of testimony: "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. (42)
• Feb 1998 – One year after threatening to revoke the license of Michigan Biologic Products Institute, FDA issues inspection report on the sole anthrax production plant which begins: "The manufacturing process for Anthrax Vaccine is not validated." (43)
• Mar 1998 – Sole anthrax vaccine production plant is closed for "renovation" following unsatisfactory FDA report the prior month. DOD is paying for cost of renovation. (44) All vaccinations given under AVIP to-date are from stocks existing prior to plant closure. Bioport (formerly Michigan Biologic Products Institute) was allowed to conduct supplemental tests of its own product before it was shipped for use in the AVIP. Mitretek Corp conducted monitoring of the test results and procedures. DOD later suspended supplemental testing due to "inconsistencies" in the testing procedure and sent a "Tiger Team" to Bioport to resolve the problem. DOD expects to resume supplemental testing in late 1999. (45)
• 2 Mar 1998 – In response to threat assessment by the CINCUSCENTCOM, anthrax vaccinations begin before the SECDEF-mandated four-part review is complete. On the same day Dr. Burrow's report is submitted, DOD declares the review complete only for CENTCOM. Contrary to Dr. Burrow’s recommendations, DOD communications on anthrax were inadequate and misleading. Many Servicemembers were not advised of how to submit a Vaccine Adverse Event Reporting System (VAERS) report and it appears DOD did not have a system designed to track adverse reactions.
• Apr 1998 – First large-scale refusals to take the vaccine occur – ten sailors on USS Independence. Grassroots effort to counter AVIP begins, initially led by the mother of a Navy sailor who became ill after being inoculated. (46)
• 18 May 1998 – SECDEF Cohen approves AVIP for all DOD military personnel. Same day President Clinton issued Presidential Decision Directive PDD-62, ordering federal agencies to take significantly expanded and better-coordinated steps to protect against the consequences of biological and other unconventional attacks, especially potential bioterrorism directed at civilian populations. Special new funding of $144 million was added for HHS efforts in FY 1999, bringing total HHS spending on bioterrorism preparedness to $158 million this year. FY 2000 budget will propose another significant increase to a total $230 million. (47)
• 14 Aug 1998 – Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs, and RADM Michael Cowan, Joint Staff J-4 Medical Readiness, hold a press briefing to attempt to respond to increasing refusals by Servicemembers to be vaccinated. (48) Cowan states: "But our position is this is very safe. I've also taken it. I have absolutely -- none of us have any concerns. And we think it's of the order of magnitude of saying to someone, ‘You have to wear your helmet.’
• Sep 1998 – Congress changes federal law restricting use of federal military Reserves (not National Guard) from activation for "serious natural or manmade disaster, accident, or catastrophe." (49) Reserves may now be used "to provide assistance in responding to an emergency involving a use or threatened use of a weapon of mass destruction." (50)
• Jan 1999 – When the first unit in the Air Reserve Components faced mandatory inoculation, eight CT Air National Guard pilots (25% of the combat arm of the unit) refuse anthrax vaccine and are told to resign and transfer from their unit. (51) These officers worked within chain of command for five months seeking answers to questions on safety, efficacy, and necessity of vaccine, but were told "there are no answers to your questions." (52) After researching the AVIP issues the officers chose to resign and transfer in lieu of disobeying a direct verbal order from their Commander. (53)
• 22 Jan 1999 – President Clinton gives address to National Academy of Sciences on "Keeping America Safe in the 21st Century." He states: "We have to be ready to detect and address a biological attack promptly, before the disease spreads." (54) White House emphasizes significant increase in funding to develop vaccines. (55)
• 25 Jan 1999 – In response to increasing refusals to accept the vaccine, eight reserve component general and flag officers attend semi-annual convention of the Reserve Officers Association and are vaccinated en masse on stage. (56) Government Executive magazine acknowledges "dozens of troops have refused the Pentagon's recent order to be vaccinated against Anthrax because they don't trust service leaders' assertions that the vaccinations are safe." (57) ROA concluded their convention with the passage of a resolution supporting vaccine protection, BUT NOT WITH THE CURRENT STOCKPILE – a compromise recognizing potential problems with the vaccine. (58)
• Jan-Feb 1999 – Joint Staff prepares answers to CT Air National Guard officer’s questions in preparation for a possible "20/20" report that ultimately does not delve into the questions. (59)
• Feb-Mar 1999 – USAF Airman Bettendorf demands court-martial in response to threatened punishment for refusal to accept vaccination. (60) Defense counsel requests for samples of the vaccine during pre-trial discovery were refused by the government. (61) USAF ultimately grants a general discharge, under other than honorable conditions, avoiding a trial. (62)
• Jan-Apr 1999 – The first unit in the USAF Reserve to face mandatory inoculation, the 79th Air Refueling Squadron, had 20 KC-10 tanker aircrew resign (just less than 50% of the aircrew in the unit). USAF attempted to obscure the number of pilots, who resigned or transferred in these units due to anthrax, then later admitted actual numbers. Potential retention problems in other reserve component flying units exist if vaccinations continue, which may exacerbate a growing shortage of pilots throughout the military. It costs $6 million to train a new pilot, and pilot production is already running at capacity.
• 9 Feb 1999 – Department of Health and Human Services announces initiative on domestic bioterroism response. (63)
• 16-17 Feb 1999 – National Symposium on Medical and Public Health Response to Bioterrorism hosted by Johns Hopkins University in Arlington, VA. (64) Dr Phillip Russell of Johns Hopkins and formerly director of USAMRIID advised "against further development of this [anthrax] vaccine, and emphasized the need for a "second generation vaccine" which could be given in 2 doses, preferably with purified antigen as the immunogen." (65)
• 9 Mar 1999 – SECDEF Cohen tells troops in Kuwait that he would be "derelict" in his duties if he failed to protect U.S. service members from anthrax and other biological weapons, and he also told them the vaccine is completely safe. (66)
• 9-10 Mar 1999 – Conference on WMD & Domestic Preparedness: Integrating First Response & Medical Management in Washington, DC. Keynote address by Johns Hopkins Univ. Dr. Thomas Inglesby on response to bioterrorism. (67)
• 24 Mar 1999 – Representative Shays (R-CT) begins first of four hearings by the House Government Reform Subcommittee on National Security on the safety, efficacy, and necessity of AVIP. (68)
• 29 Mar 1999 – GAO releases a report on squalene adjuvants in vaccines and a possible link to Gulf War Illness. (69) Subsequent articles in Vanity Fair (70) and Insight Magazine (71) elaborate on GAO report by detailing findings of independent medical researchers. Congressman Metcalf (R-WA) calls for hearings by House Armed Services Committee.
• 31 Mar 1999 – DOD modifies (accelerates) AVIP. All U.S. military personnel and DOD emergency essential civilians and contractors who travel to Southwest Asia and the Korean peninsula for duty of any duration will receive the anthrax vaccination series. (72) Previous requirement was to be vaccinated if deployed for more than 30 days to one of these areas. (73)
• 1 Apr 1999 – In response to AVIP hearings by the House Government Reform Committee the Association of American Physicians and Surgeons submitted a report including the following statement: "Informed consent must be observed even by military. No consent can be informed if the information is based on science that violates fundamental precepts of honesty and integrity and lacks a proper research design that can disprove the hypothesis of safety if indeed there are significant adverse effects." Doctors for Disaster Preparedness, a national organization of physicians and scientists, also submitted a statement recommending more comprehensive protection: "Because of the limited efficacy of the anthrax vaccine, prevention of exposure with shelters and protective gear remains indispensable." (74)
• 21 Apr 1999 – USAF airman is convicted in a summary court-martial for refusal to take anthrax vaccination and convicted to one month in confinement. (75) The USAF prosecuting attorney (JAG) stated after the trial: "People need to think twice before accepting at face value everything they see on the Internet… There's a lot of half-truths, misinformation and outright lies out there, and it really should not be looked at as an infallible source of reliable information." (76)
• 29 Apr 1999 – 2nd House Committee on Government Reform hearing is held covering FDA oversight of anthrax vaccine. The last two hearings will investigate manufacturer practices and procurement, and doctrinal implications of the program will occur in June and the fall of 1999 respectively. Hearings reveal DOD has suspended supplemental testing of anthrax vaccine by manufacturer and sent a "Tiger Team" to Bioport to remedy problems. Additionally, Dr Sharma, GAO investigator, testified that the FDA approved the vaccine in 1970 without evaluating the 3 main differences between the '50s/'60s vaccine - the new manufacturing process, the new strain of anthrax used to make the vaccine, and the new adjuvant. (77)
• Apr-May 1999 – ADM Jay Johnson, Chief of Naval Operations, continued to decline to be vaccinated. His office states that he is not scheduled for vaccination until 2003 – well after his retirement from the Navy. (78)
• May 1999 – Additional Representatives join Rep Metcalf’s (R-WA) and Rep Shay’s (R-CT) in the call for a moratorium on the mandatory inoculations until further review is conducted – Rep Souder (R-IN), Rep Jones (R-NC), and Rep Mica (R-FL). Additional elected representatives are expected to follow.
• 5 May 1999 – Following at least two adverse reactions at Dover Air Force Base in Delaware Col. Felix Grieder, the wing commander, temporarily suspended vaccinations on the 3,600 Servicemembers. His spokesman explained the performance of a Pentagon briefer sent to explain the shots had been "inadequate to dispel rumors and misinformation" about the vaccine's safety. (79) Later reports from the military spokesman confirmed at least four adverse reactions, while further investigation with unit members revealed Col Grieder's troops had at least 8 adverse reactions, with more suspected among pilots who are reluctant to report.
• 11 May 1999 – Col. Felix M. Grieder's stand was short-lived. The shots were resumed at Dover AFB on Tuesday after Grieder was briefed by high level Air Force officials. A USAF Surgeon General visited the base and supplied the DOD’s answers to questions on vaccine safety posed by airmen in two closed sessions. After he suspended the program, Grieder was called to Washington Monday to confer with high level Air Force officials. (80)
• 25-27 May 1999 – A DOD informational meeting was held at Fort Detrick, MD for 100 military physicians. Data presented casts doubts on previous DOD claims of safety. Briefing slides included the following statistics: (81)
  • In a study of 337 vaccinated Servicemembers from Korea, the rate of any reaction (from very minor to severe) was 40% in men, but 70% in women. Reactions led to "decreased activity" in 3% of males, and 8% of females.
  • The ongoing study of 600 Servicemembers at Tripler Army Medical Center, Hawaii, resulted in 20% (120 people) developing a systemic reaction after at least one of the first three injections. Only 4 VAERS have been filed for this group.
  • At Dover Air Force Base, 20-25 persons have been identified with a similar, Gulf War-like illness resulting in a more than 50% reduction in function, compared to their pre-vaccine state, according to Col. (Dr.) Renata Engler, Chief of the Allergy/Immunology Department, Walter Reed, and Consultant to OTSG, Allergy-Immunology.
• 11 June 1999 – Five Marines who refused an anthrax vaccine at Twenty-Nine Palms MCAS, California face court-martials. A judge ruled the men were given a lawful order when they were told to take the shot. Investigative news research though alludes to the realization that a more complex story is emerging: (82)
  • CBS News has uncovered information that calls into question the credibility of the anthrax vaccine. In April, the General Accounting Office echoed concerns of the refusnik marines, reporting "the long-term safety of the vaccine has not yet been studied".
  • The Food and Drug Administration questions whether the vaccine even works against wartime use of anthrax spread through the air: "its efficacy against inhalation anthrax is not well documented."
  • In 1997, when the FDA finally gave the Pentagon permission to use the vaccine for mass immunizations, it was anything but a ringing endorsement. "There is a paucity of data regarding the effectiveness of anthrax vaccine," wrote Lead Deputy FDA Commissioner Michael Friedman.
• 19 June 1999 – At least six pilots in the Wisconsin Air National Guard are expected to refuse anthrax vaccines ordered by the U.S. Department of Defense and could face expulsion from the service or be forced to resign. Mike Angarole, a lieutenant colonel and fighter pilot, said he hasn't officially refused to take the shots but has notified his commanders that he does not plan to take them by the July 24 deadline for Wisconsin Guard members. Another Wisconsin Guard pilot, Randy Psyk of Stoughton, said he has officially informed his unit commander that he will not take the anthrax shot. (83)
• June 1999 – US Air Force Reserve Colonel Redmond Handy speaks out against the AVIP. Col. Handy is the 1996 National Award Recipient -- Reserve Officer Association Outstanding Individual Air Force Reserve Officer of the Year -- Chosen from among 5,000 eligible field grade individual (non-unit) reservists. Active Duty and Reserve from 1975 to 1999, Col. Handy attained the rank of O-6 before retiring as a Ltc in deference to the AVIP. Col. Handy served numerous special Pentagon tours for the last 7 years supporting the AF Reserve and logistics. Col. Handy testified at the first hearing to review the AVIP setting the precedent for senior military officers to professionally encourage a review of the anthrax policy. (84)
• 24 June 1999 – NEWS RELEASE: Congressman Christopher Shays of Connecticut, and the House Subcommittee on National Security, Veteran Affairs and International Relations will convene June 30 for a Hearing on the DOD's Sole Source Procurement of the Anthrax Vaccine. "Since the Gulf War, DOD has pursued a sole source strategy to acquire anthrax vaccine," Chairman Shays said. "Other production sources and other vaccines were not pursued. Now the Pentagon is locked in a dependent relationship with a new, unproved company. It appears DOD may have misjudged the financial and technical capabilities of the company to perform under the contract." At the Subcommittee's request, the General Accounting Office (GAO) studied the structure and nature of the relationship between DOD and BioPort, and will present new findings at the hearing. Shays said, "A mandatory, force-wide immunization program ought to be based on more than an optimistic business plan. Resting on so weak a foundation, the anthrax vaccine program may not be safe or sustainable." (85)
• JUNE 1999 – US Marines imprisoned due to their professional dissent to a DOD policy. Servicemembers concerns, hearings in Congress, the impact on readiness, and media reports appear to support the need for further review.

  Jason Austin, 22, of Fritch, Texas
  Michael McIntyre, 22, of Mount Vernon, Washington
  Jared Johnston, 19, of Henryetta, Oklahoma
  Michael Metzig, 20, of San Diego, California
  Jared Schwartz, 20, Henderson, Kentucky
• 29 June 1999 – Even as the Pentagon is conducting a comprehensive educational campaign to convince American troops that mandatory anthrax vaccinations are safe, military documents indicate high-level acknowledgment of potential dangers. Documents obtained by The San Diego Union-Tribune show that Secretary of the Army Louis Caldera agreed in September 1998 to accept the burden of potential liability claims made against the vaccine manufacturer by service members. The vaccine, according to a memo signed by Caldera, "involves unusually hazardous risks associated with the potential for adverse reactions in some recipients and the possibility that the desired immunological effect will not be obtained by all recipients." Moreover, the Secretary concluded, "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" during warfare. (86)
• 1 July 1999 – The Washington Post reports that the only U.S. company that produces anthrax vaccine has run into serious financial trouble, imperiling a Pentagon program launched recently to immunize all U.S. troops against the deadly germ warfare agent said Rep. Christopher Shays (R-Conn.), who yesterday chaired a House subcommittee hearing on the matter. He pressed BioPort executives on how they could have so miscalculated, and he chided Pentagon authorities for making a critical program dependent on a newly established manufacturer that evidently was undercapitalized and overly optimistic about its prospects. "BioPort's financial troubles engender fears that cost-cutting will affect vaccine quality. It should raise grave concerns about the security of the sole production facility and the predictability of vaccine supply," Shays said. Top officials from BioPort Corp. said yesterday that renovation delays and other transition problems after their purchase of the vaccine production facility from the state of Michigan have pushed the company close to bankruptcy. Unless the Pentagon agrees to more than triple the price it pays for the vaccine--from $3.50 to about $10 per dose--company officials suggested they have little hope of meeting the terms of a $29 million contract with the Defense Department. (87)
• 4 July 1999, Independence Day – Effort of citizens, parents, and military members uncovered a second indemnity document repeating language disputing earlier claims of safety and efficacy by the DOD. The new document also dealt with the production of anthrax and relieved an additional contractor from liability. The Secretary of the Army, M.P.W. Stone, on 3 September 1991, granted the MEMORANDUM OF DECISION under the authority Public Law 85-804 to include an indemnification clause in contract DAMD17-91-C1086 between Program Resources, Inc. (a wholly owned subsidiary of DynCorp.) and the US Army's Medical, Research and Development Command (USAMRDC). According to the indemnity document the contract stipulated that after bulk lots have been produced, the vaccine would be shipped to the Michigan Department of Public Health (MDPH) in Lansing, Michigan. There, under separate contract, MDPH would perform the purity testing, bottling and labeling of the vaccine. This contract would be performed in conjunction with Interagency Support Agreement No. Y03-CO-10567 between the National Cancer Institute and USAMRDC. The obligation assumed by PRI under this contract involves unusually hazardous risks associated with potentially severe adverse reactions and the potential lack of efficacy of the anthrax vaccine. According to the document these concerns stemmed from:
  1. The limited use of the vaccine to date, i.e., tests prior to approval of a vaccine by the Food and Drug Administration were on too small a scale to permit accurate assessments of types and severity of adverse reactions (only widespread use can provide this assessment);
  2. Insufficient experience in mass immunization programs to have truly evaluated the efficacy of the vaccine. Moreover, there was no way to predict whether the pathogen against which the vaccine could be used would be sufficiently similar to the pathogen used in tests to ensure vaccine efficacy. The Sec. of the Army found that performance of this contract would subject PRI to certain unusually hazardous risks defined in ATTACHMENT A:

     DEFINITION OF UNUSUALLY HAZARDOUS RISKS: The risk of adverse reactions, or the failure to confer immunity against anthrax, from the administration to any person of the vaccine manufactured or delivered under this contract. For purposes of this clause, the phrase "adverse reactions" included anaphylaxis and other foreseeable adverse reactions, as well as, any unforeseen adverse reactions. (88)

• 12 July 1999 -- Responding to concerns about the safety of anthrax immunizations, the Department of Defense now plans a study on the vaccines' long-term health effects. Although the vaccine has been licensed since 1970, no long-term studies have been done on the long-term effects. Fear of the unknown is causing concern among service members, particularly among the 300,000 who have received the shot. Many are alarmed by a notice included in the vaccine which says no studies have been performed to determine whether the vaccine could affect reproduction or cause cancer. Those two questions are among the issues to be addressed by the long-term study, said Army Maj. Guy Strawder, director of the Anthrax Vaccine Immunization Program Agency. The lack of long-term studies "is the number one concern right now of service members," he said. But, he said, the anthrax vaccine is being held to "a higher standard" than other vaccines, which also lack long-term studies. A six-person team will design the study -- three from the Department of Defense and three from the private sector. (89)
• 14 July 1999 -- POC -- (202) 225-2548, Congressman Christopher Shays convenes July 21 Hearing on adverse reactions of DOD's Anthrax Vaccine Program. Hearing on July 21 to examine the Anthrax Vaccine Immunization Program (AVIP), focusing on the willingness and ability of the Department of Defense to acknowledge, diagnose and treat adverse reactions. The hearing was announced today by Congressman Dan Burton (R-IN), Chairman of the Committee on Government Reform. "The rigorous practice of medicine, not aggressive public relations, should be driving the adverse event reporting process," Shays said. "But it appears the program glosses over potential side-effects, fails to offer legitimate medical exemptions from the inoculation, and resists attempts to associate adverse reactions with the vaccine. So we have to ask: Who's protecting the force from the harm caused by this medical force protection program?" (90)
• 16 July 1999 -- CONTACT: Kimberly Nielsen, 202-225-3415; JONES CALLS FOR ANTHRAX VACCINE PROGRAM TO BE MADE VOLUNTARY -- Bill Scraps Mandatory Program Until FDA Approves New Vaccination or Reduced Shot Course -- Congressman Walter B. Jones (R-NC), Member of the House Committee on Armed Services, today introduced legislation to make the current Department of Defense anthrax vaccination immunization program voluntary for all members of the Uniformed Services. Jones' bill, the American Military Health Protection Act, will make the current mandatory program voluntary to United States military personnel until the Food and Drug Administration (FDA) approves a new anthrax vaccination for humans or approves a reduced course of shots, down from the existing six-shot program. "The lack of a single, conclusive independent study on the long-term health effects of the anthrax vaccine in humans has created legitimate growing concerns among our men and women in uniform," Jones said. "Despite continued assurances by the Department of Defense that adverse reactions to the vaccination are minimal, the Department's standards used to measure the reactions haven't been able to support their claims." (91)
• 21 July 99 -- Additional Legislation announced by Congressman Gilman, NY -- Department of Defense Anthrax Vaccination Moratorium Act, HR 2548 IH 106th CONGRESS -- To suspend further implementation of the Department of Defense anthrax vaccination program until the vaccine is determined to be safe and effective and to provide for a study by the National Institutes of Health of that vaccine. The Secretary of Defense set out four specific conditions that had to be met before the vaccination program could start: First, supplemental testing to assure sterility, safety, potency, and purity of the vaccine stockpile; second, implementation of a system for fully tracking anthrax immunizations; third, approval of operational plans to administer the vaccine and communications plans to inform military personnel; and fourth, review of medical aspects of the program by an independent expert.
  • According to the hearing testimony before the subcommittee, none of these conditions was satisfactorily addressed before the vaccine program was implemented.

    Sections of the bill include:

    SEC 1. SHORT TITLE: This Act may be cited as the `Department of Defense Anthrax Vaccination Moratorium Act'.

    SEC. 2. SENSE OF CONGRESS. It is the sense of Congress that--

    (1) a single force protection measure such as the mandatory anthrax vaccine immunization program should not be implemented by the Department of Defense without regard for that measure's own effects on morale, retention, recruiting, and budget; and

    (2) an insufficiently proven vaccine should not be advocated as a substitute for research, development, and production of truly effective vaccines and essential antibiotics, adequate personal protective equipment, detection devices, and nonproliferation measures.

    SEC. 3. MORATORIUM OF VACCINATION PROGRAM.

    SEC. 4. STUDY BY NATIONAL INSTITUTES OF HEALTH.

    SEC. 5. GENERAL ACCOUNTING OFFICE STUDY.

    SEC. 6. BOARDS FOR CORRECTION OF MILITARY RECORDS -- The Secretary of Defense shall direct that the respective Boards for Correction of Military Records of the military departments shall, upon request by individual members or former members of the Armed Forces, expedite consideration of applications for remedies for adverse personnel actions (both voluntary and involuntary) that were a result of the mandatory anthrax vaccine immunization program, to including rescission of court-martial convictions, rescission of administrative discharges and separations, rescission of retirements and transfers, restoration of flying status, back pay and allowances, expunging of negative performance appraisal comments or ratings, and granting of physical disability certificates.

    SEC. 7. CONTINGENT RESUMPTION OF VACCINATION PROGRAM. (92)

• 21 July 1999 -- CONGRESSIONAL HEARING STATEMENTS BY CAPTAIN MICHELLE L. PIEL, LT. RICHARD J. ROVE, CAPTAIN JON RICHTER, and SSG ROBERT H. SOSKA JR. -- Comments respectively include: (93)
  • " All my life I've wanted to fly and serve my country to the best of my ability. As an Air Force Academy graduate, I've had every opportunity to achieve both. I've enjoyed a rewarding career serving with the finest people I will ever know. I owe a debt of gratitude to everyone who has helped me along the way over the past 13 years. I would like to take the opportunity to express my sincere appreciation to my Wing Commander who found quality medical care for me. If it weren't for the fact that he temporarily suspended the anthrax program at Dover AFB, I would still be lost in our military medical system. My desires are simple: to regain my health and return to flying."
  • "The Proud Sons and Daughters of the United States who voluntarily serve this great nation of ours are confused. Morale is being eroded throughout the ranks on this volatile issue. The common theme is a lack of trust. There have been numerous recantations of information that was originally put forth in regards to this vaccine. We are told time after time that the vaccine is entirely safe, yet there is a disparity between what we are told and what we are seeing."
  • "Those in command seem to have shrugged their shoulders at the numbers of people leaving military service with the attitude that an order was given and it should be carried out. We are growing tired of the denials that everything is okay when in fact it isn't. Over twelve years ago, I raised my right hand and solemnly swore to support and defend the constitution against all enemies foreign and domestic and to obey the orders of the officers appointed over me. I took that oath freely and willfully. I knew that I could and would give my life for my country. And on several occasions during the course of my military flying career I almost made that sacrifice as have many others. But at no time did I ever agree to be slowly poisoned, however well intentioned, under the guise of being "combat ready" so that every day is one filled with pain. That wasn't part of the contract as I know it. I have defended my country and I have obeyed the orders of the officers appointed over me. But taking another anthrax shot is not an order I can carry out"
  • "I want to thank this committee for your concern regarding our reactions to this vaccine. I ask that you ensure that we soldiers who are sick receive the appropriate care and medical attention we desperately need. We can not do this on our own. I also ask that you prevent this from happening to other soldiers before it disables a large portion of our military as a whole and adversely affects our national defense."
• 26 July 99 -- Secretary of Defense William S. Cohen authors "Preparing for a Grave New World," pg. A19, Washington Post. The piece includes statements such as, "we cannot afford a national case of farsightedness that precludes us from focusing on threats closer to home, such as the potential danger of a chemical or biological attack on U.S. soil." And, " What would that day look like? A biological agent would sink into the respiratory and nervous systems of the afflicted. The speed and scope of modern air travel could carry this highly contagious virus across hemispheres in hours." And finally, "our military response efforts will be grounded primarily in the National Guard and Reserve. In contrast to their more familiar role of reinforcing active-duty forces overseas, our guard and reserve are the forward-deployed forces here at home." (94)
  • This Letter to the Editor appears to be the first public acknowledgment that the AVIP program is for all military members, active, guard and reserve in order to provide a bio-terrorism defense force on the domestic front. If so, it is the latest evolving truth recently unveiled about the program. If not, it is an attempt to use fear to generate support for a military medical program under attack. Anthrax; the disease, the vaccine, and the threat are not new. What is new is the decision to respond reactively and defensively to a dynamic threat. The same threat was successfully handled throughout our nation's history with a credible offensive deterrence capability.
• 13 August 1999 -- Anthrax Vaccine Deal Criticized -- The Hartford Courant reported a Pentagon deal allowing the manufacturer of the controversial anthrax vaccine to more than double the price of the shots and receive an $18.7 million interest-free advance payment. The deal is drawing fire from military watchdogs, soldiers and members of Congress. U.S. Rep. Christopher Shays said, ``Am I going to examine this deal? You bet your life I am. From [the Defense Department's] standpoint, it's like play money . . . it's like a hiccup,'' compared to the overall defense budget, Shays said. ``There is no excuse. BioPort agreed to a price. ... This is one of the major problems with the Pentagon sole-sourcing a product. They can be held hostage by the sole provider.'' But some question why the shots are being given at all. ``I just cannot understand the panic,'' said former Rear Adm. Eugene Carroll, deputy director of The Center for Defense Information, a defense watchdog organization in Washington, DC. ``Without an actual threat of attack and without validating the ability of this company to produce the product, they are spending this money on the anthrax vaccine.'' (95)
• 14 & 16 August 1999 -- OP EDs in the Washington Post -- The first, by Milton Leitenberg, a senior fellow at the Center for International and Security Studies at the University of Maryland, says Secretary of Defense William Cohen has made the potential use of biological or chemical agents by terrorist groups or individuals his personal signature contribution to the national security debate in the past several years. He concludes that, "Either the advice reaching the secretary of defense and other senior officials on this subject is extraordinarily poor, or they are intentionally disregarding real-world experience. 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." (96) The second Op Ed titled, "A Plague of Publicity," by Leonard A. Cole, a professor of political science at Rutgers University, writes that, "Last month Secretary of Defense William S. Cohen warned that a biological weapons attack on American soil could be imminent. He urged the country to prepare for a 'plague more monstrous than anything we have experienced. There is not a moment to lose,' he said. Cohen's fevered warning typifies an official mood that has swung from complacency to disquieting hype. Even President Clinton has announced that the thought of a germ attack keeps him awake at night." Mr. Cole concludes that, " Administration-backed funding for bioterrorism defense programs in several agencies has mushroomed from $91 million in 1998, to $244 million in 1999 and to an anticipated $334 million in 2000. Many experts think these amounts are appropriate. So it is hard to understand what purpose more doomsday rhetoric is supposed to have. In any case, no rhetoric should be acceptable that in the end spurs actions that traumatize thousands of citizens unnecessarily. While the risk of bioterrorism may have increased in recent years, insisting that a real attack is imminent or inevitable is gratuitous. Indeed, continuing a stream of alarmist statements is likely to provoke only more anxiety and more hoaxes. (97)
  • Both of these recent Op Eds in response to SecDef Cohen's own writings appear to be a modern form of McCarthyism. The Cold War's hype of the communist threat created fear and an admonishment of all who would dare to be soft on communism. History was not kind to this technique. Similarly today's senior Department of Defense officials appear to be hyping the age-old threat of biological weaponry. The action appears to be viewed as irresponsible at best in the eyes of the academic and scientific community. If the hysterical creation of a new and imminent threat is intended as a means of defending the intense criticism to the DoD's first line of defense -- the anthrax vaccine -- it is evident the tactic is not working, and is merely tarnishing the credibility of our militaries' leaders.
• 17 August 1999 -- "The Anthrax Vaccine: Safe, Effective and Necessary": By Charles L. Cragin, Acting Assistant Secretary of Defense for Reserve Affairs. Mr. Cragin writes a Letter for the American Forces Press Service. In the article he maintains, "One of warfare's guiding principles has always been that a weakened enemy is a more easily defeated enemy. Historically, this principle seems to have had particular relevance when it came to biological weapons. The first recorded use of biological warfare involved the Romans, who placed animal carcasses in the water supplies of their enemies -- an act of creative attack that poisoned the water, thinned the opposition's ranks and dealt a mortal blow to enemy morale. In later centuries, the Tartars took this concept one step further by catapulting bodies infected with bubonic plague over the walls of besieged cities." Mr. Cragin continues with the fact that today anthrax emerges as a preeminent threat and concludes that, "Above all, understand the basic facts: Anthrax kills, vaccination protects. (98)
  • What Mr. Cragin fails to include in his historical discussion are more recent events where the millennium old dilemma of biological warfare, anthrax included, has been courageously tackled in this century with what military philosophers and historians call the CB (Chemical and Biological) Taboo. Several examples of international agreements upholding the CB Taboo include: Article 5 of the Washington Treaty of 1922, the Geneva Protocols, and the Hague Conventions, and the 1972 Weapons Convention.
• August 1999 -- Insight magazine examines the anthrax vaccine debate in a two-article report. The magazine wrote, "While Crowe declined repeated requests for interviews, his chief spokesman, Jay Coupe, says, 'Do you think the admiral would subject himself or the military to a shot if he didn't believe it was safe?' Coupe downplays the critics, saying that they're mostly 'just reservists.' He adds, 'Do you think they have the intelligence of the secretary of defense, who has taken the shot, or Admiral Crowe, who has 50 years of military service? Let me put it another way. Who do you think would have more access to more information? The secretary of defense or a pilot? You should look at the motives -- some of these pilots may not want to be deployed.' " (99)
  • To date our DoD has made multiple similarly derisive comments about the intentions of their own Servicemembers. In the ongoing professional pursuit for a review of this policy the divisive comments by senior DoD spokesman, or spokesman for retired senior military leaders, about members of our total force is at the very best irresponsible. Comments such as these are unsubstantiated, and disappointingly unprofessional.
• 29 August 1999 -- The Hartford Courant reports that, "Program Lags In Battle Against Anthrax." The author wrote that, "Large percentages of people serving in military reserve and National Guard units are not receiving their mandatory anthrax vaccinations as required under stringent schedules, military documents show. The highest percentage of those not receiving all their scheduled shots - 88 percent - is in the U.S. Navy Reserve, according to documents obtained by The Courant from a knowledgeable government source. Other non-compliance percentages are: U.S. Marine Corps Reserve, 72 percent; U.S. Army Reserve, 63 percent; U.S. Army National Guard, 59 percent; U.S. Air Force Reserve, 33 percent; and U.S. Air Force National Guard, 27 percent. The figures were based on results as of July 31." (100)
  • The high attrition, listed at the end of this chronology, in conjunction with a severe lack of compliance is endemic of a flawed policy that warrants review. The review of the AVIP is moving at a rapid pace compared to other historic examples of military medical controversies (i.e., nuclear testing, Agent Orange or GWI). The professional dissent to this program and the legislation (H.R. 2543and H.R. 2548) are testimonies to the widespread concern shared by servicemembers and their legislators
• 17 September 1999 -- MATTHEW HAY BROWN; Hartford Courant Staff Writer; writes that Reprensentative: JOHNSON CRITICAL OF ANTHRAX POLICY; U.S. Rep. Nancy L. Johnson has asked Defense Secretary William Cohen to stop dishonorably discharging soldiers who refuse potentially harmful inoculations for anthrax. ``Forcing our men and women in uniform to choose between this vaccine and their careers fosters distrust and erodes morale,'' the New Britain Republican said Monday. ``We shouldn't continue down this path until we have more conclusive evidence. In testimony before a House subcommittee, Air Force Lt. Richard Rovet, health-care integrator for the flight medicine clinic at Dover Air Force Base, said symptoms of exposure to the vaccine include joint pain, memory impairment and cardiac problems. In a letter to Cohen last week, Johnson expressed her ``vehement opposition to dishonorably discharging service members because they fear the health consequences of the mandatory anthrax vaccine.'' Johnson said she has been contacted by soldiers, and their families troubled by reports of negative side effects. ``Every soldier is well aware of the dangers that come with serving in the military,'' Johnson said. ``But I doubt they ever expected their government would force them to take a vaccine that has unknown long-term effects.'' (101)
• September 1999 -- Despite coverage by some other papers, the USA Today, the New York Times, & the Washington Post have had extremely limited or nonexistent coverage on this topic. The issues involve both an unsubstantiated mantra on the claims of safety, efficacy, and doctrinal necessity of the vaccine, but also our own DoD's less than forthright communications efforts to "sell" this vaccine to Servicemembers. The article at the hypertext link below highlights the integrity issues Servicemembers have with the policy: http://www.sftt.org/articles/shooting_straight.shtml (102)
• 15 September 1999 -- The Phase I Report on the "Emerging Global Security Environment for the First Quarter of the 21 st Century" by the The United States Commission on National Security, chaired by former Senators Warren Rudman and Gary Hart, contains the following statement:
  "Biological weapons experts formerly employed by the Soviet Union have testified that the extent of the Soviet program was massive, but that control of the physical and intellectual assets of the former program is virtually nonexistent. Accordingly, a variety of improved toxins and biological agents are becoming more widely available. Technological developments in genetics and biotechnology portend even more sinister advances with the design and deployment of genetically engineered pathogens that could thwart most antibiotics and vaccines, and readily outcycle our detection, antidote development, and distribution timelines. These could include genetically-altered smallpox."
• 24 September 1999 -- Hartford Courant develops conclusive weblink to anthrax dilemma based on all stories covered to date. The integral article covers the Hurricane Floyd events where all doses of base vaccine in the NY Air National Guard were destroyed rather than administering potentially dangerous inoculations to the troops. The decision to not inoculate was supported by the Director of the ANG, and the NY ANG leadership, despite assurances by the CDC and the NGB Surgeon General. The Asst. Sec. of Def. As well visited the base just prior to the inoculations and discovered that over 50% of the pilots would leave if ordered to take the inoculations. Luckily, disaster averted disaster and the NY ANG continues to fly their missions without inoculations or losses to readiness. (103)
• 29 September 1999 -- 5th hearing on the AVIP by the House Subcommittee on National Security. Congressman Shays shared in his opening remarks: "The Anthrax Vaccine Immunization Program (AVIP) has two serious problems: Highly-trained, veteran members of reserve components - Reserve and National Guard units - are opting to leave military service, citing unresolved questions about the safety, efficacy and necessity of the anthrax vaccine program. And, for those taking the vaccine, recent tracking data from the Department of Defense (DoD) confirms the worst fears of those who doubted the Department’s ability to keep accurate medical records and comply with the FDA-mandated inoculation schedule. (104) During this hearing four Servicemembers spoke out including Ltc Tom Heemstra, Former Sqd. Commander, IN ANG F16s, and first Commander worldwide to stand up for his troops in questioning the AVIP. During this hearing the Director of the Air National Guard, MG Weaver testified that only "one" (1) Servicemembers has been lost in the Air National Guard to this policy. (105)
• 30 September 1999 -- 1st House Armed Services Committee Hearing on AVIP held partially in closed session. During this hearing the Chairman, Rep. Buyer, a lieutenant colonel in the Army Reserves, commented: 'What I find unique here at the moment is there is perhaps not a specialty in the force - pilots - that I end up spending so much of my personal time on their issues,' Buyer said. 'They are the most pampered in the world. If you don't get your air-conditioning and your pizza on time, you complain. I would have loved to have the conditions you had in the Gulf. I never showered in five months.' The weekend following this hearing 28 aircrew and 32 additional support personnel refused to be inoculated with the vaccine in question at the TN ANG in Memphis and submitted their resignations or transfer requests. (106) Coincident with this hearing the Commander in Chief announced an Executive Order establishing the waiver of informed consent authority and accountability at the highest level of government. (107)
• 12 October 1999 -- Government Reform Committee holds hearing on the Anthrax Vaccine, "Defense Vaccines: Force Protection or False Security?" In his opening statement Congressman Burton asks, "The Full Committee today will examine the overall picture of vaccines for defense. As part of our ongoing investigation into vaccines, we are examining their safety, efficacy, the importance of informed consent, the concerns about vaccine ingredients, purity, and the long-term safety concerns. We are looking into the role of vaccines as a defense mechanism for biological warfare. Is it viable and appropriate to use vaccines as a defense mechanism? Will it be possible and practical to develop vaccines to protect against all known and potential biological threats. (108)
• 19 October 1999 -- Pyridostigmine bromide (PB) report made public by DoD and the Rand Corporation. Additional coverage on this debate and anthrax covered in USA Today, and on PBS. (109)
• 20 October 1999 -- Rep. Shays holds a hearing on "Combating Terrorism: Assessing the Threat" in the Subcommittee on National Security, Veterans Affairs, and International Relations. Additional hearings were held in the House Armed Services Committee. (110)
• 25 October 1999 -- GAO Releases Report on the Anthrax Policy Administration -- Washington Times says, "Pentagon's Anthrax Program Found Plagued With Problems, Vaccination of entire force behind schedule, poorly recorded." The report is titled: Medical Readiness: DoD Faces Challenges in Implementing It's Anthrax Vaccination Immunization Program, GAO/NSIAD-00-36, October 22, 1999. (111)
• 3 November 1999 -- Congressman Gilman, Jones, Burton and Shays deliver a message to the FDA asking them to deem the Anthrax vaccine as investigational in accordance with the Federal Register. The Representatives also asked for the FDA to address important issues such as redating and relabeling, and the questionable oversight of the FDA in the past three decades.
• 23 November 1999 -- FDA completes an inspection of the Bioport facility citing 30 infractions and once again finding the anthrax vaccine manufacturing process not validated. The finding spurs the department of defense to delay the Phase 2 implementation of the AVIP. (112)

  The FDA identified 30 problem areas. Among them:
  
  * The FDA could not verify whether the company's parameters for manufacturing temperatures, stirring speed, refrigeration times and holding times would guarantee that each batch would be identical.
  
  * The company did not report that it failed potency-test results on some samples when using an FDA-approved calculation method, rather than an unapproved method company officials thought was acceptable.
  
  * BioPort has not completely demonstrated it can always manufacture the vaccine without bacterial contamination.
  
  * The company's internal procedures for reporting deviations from the normal manufacturing process lacked a timeframe for concluding investigations, and did not fully address when the deviation reports should be written.

• An ongoing Air Reserve Component effort by Servicemembers to tabulate current and future attrition due to transfers, retirements and resignations, as well as reported reactions, due to the Anthrax Vaccine Immunization (AVIP) Policy is represented by the data below:

References:

1 http://www.defenselink.mil/news/Dec1997/b12151997_bt679-97.html

2 http://www.defenselink.mil/news/Jan1999/t01211999_t121asd_.html

3 http://www.house.gov/reform/ns/press/pressreleasefor3-24.htm

4 http://www.house.gov/reform/ns/press/press4-29.htm

5 http://www.gao.gov/new.items/ns99005.pdf

6 Gary Matsumoto, Vanity Fair, May 1999, pages 82-98. No internet access.

7 http://web2.insightmag.com/investiga/gulf5.html

8 http://www.gao.gov/new.items/ns99005.pdf

9 http://www.house.gov/metcalf/spence.htm

10 http://www.house.gov/jones/pr_990427a.htm

11 http://www.defenselink.mil/news/Mar1999/n03101999_9903103.html

12 http://www.defenselink.mil/news/Dec1997/b12151997_bt679-97.html

13 http://www.house.gov/reform/ns/hearings/testimony/testimonybailey.htm

14 http://www.defenselink.mil/news/Mar1999/n03121999_9903123.html

http://www.defenselink.mil/news/Feb1999/n02091999_9902091.html

15 Thomas Williams, Hartford Courant, 26 Apr 1999, page A1, available at: http://www.courant.com/news/archive

16 http://www.house.gov/reform/ns/hearings/testimony/mrchan4-30.htm

17 http://www.sciam.com/1296issue/1296cole.html

18 http://www.foreignpolicy.com/Fall98/articles/ART4.htm

19 First Dr. Burrow Letter to DOD, http://www.defenselink.mil/other_info/burrows.html

2nd Dr. Burrow Letter to Congress, http://www.dallasnw.quik.com/cyberella/Anthrax/Burrow_4_99.htm

20 http://www.defenselink.mil/news/Mar1998/n03031998_9803036.html

http://www.af.mil/news/Apr1998/n19980416_980507.html

http://www.defenselink.mil/news/Aug1998/t08171998_t814ntrx.html

http://www.house.gov/reform/ns/hearings/testimony/testimonybailey.htm

21 Army Times, 8 Mar 1999, page 3 (also appeared in the Navy Times), www.armytimes.com

22 http://www.af.mil/cgi-bin/multigate/retrieve?u=z3950r://dtics11:1024/airforce!F105345%3a926141695%3a%28cohen%20and%20anthrax%29;esn=FT%5fTEXT%20HTML%200;ct=text/html

23 http://www.defenselink.mil/news/Nov1998/n11051998_9811051.html

http://www.usmc.mil/Anthrax.nsf – see 28 Jan 1999 comments by Commandant of Marine Corps

24 http://www.house.gov/reform/ns/hearings/testimony/testimonyoflunbom3-24.htm

http://www.house.gov/reform/ns/hearings/testimony/statement_of_sergeant_michael_4-29.htm

25 http://www.defenselink.mil/news/Dec1997/x12181997_x1215mfp.html

26 http://www.senate.gov/~judiciary/carus.htm

27 http://cns.miis.edu/research/cbw/pdd-39.htm

28 http://www.defenselink.mil/speeches/1997/di1204.html

29 http://www.defenselink.mil/news/Feb1997/b021497_bt075-97.htm

http://www.defenselink.mil/news/May1997/b050197_bt211-97.html

http://www.defenselink.mil/news/Jun1997/t060297_t0530lac.html

http://www.defenselink.mil/news/Nov1997/t11251997_t1125ptr.html

http://www.defenselink.mil/news/Dec1997/t12091997_t204usuk.html

http://www.defenselink.mil/speeches/1998/di1316.html

http://www.defenselink.mil/speeches/1998/di1317.html

http://www.defenselink.mil/speeches/1998/di1332.html

http://www.defenselink.mil/speeches/1999/s19990220-secdef.html

30 http://www.dallasnw.quik.com/cyberella/Anthrax/Mar97.html (transcript of FDA report obtained under FOIA)

31 http://www.dallasnw.quik.com/cyberella/Anthrax/warning.html (transcript of FDA report obtained under FOIA)

32 http://www.house.gov/reform/ns/hearings/testimony/mrchan4-30.htm

33 http://www.defenselink.mil/pubs/domestic/index.html

34 http://cns.miis.edu/research/cbw/domestic.htm

35 http://www.defenselink.mil/pubs/domestic/3.html

36 http://www.defenselink.mil/news/Jul1997/t07311997_t0731coh.html

37 http://www.defenselink.mil/news/Nov1997/t11251997_t1125ptr.html

38 http://www.defenselink.mil/news/Dec1997/b12151997_bt679-97.html

39 Thomas Williams, Hartford Courant, 26 Apr 1999, page A1, available at: http://www.courant.com/news/archive

40 http://www.defenselink.mil/news/Dec1997/x12181997_x1215mfp.html

41 http://www.defenselink.mil/other_info/burrows.html

42 http://www.dallasnw.quik.com/cyberella/Anthrax/Burrow_4_99.htm

43 http://www.dallasnw.quik.com/cyberella/Anthrax/anthrax1.htm

44 http://www.defenselink.mil/news/May1998/x05281998_x0522mfp.html

45 http://www.house.gov/reform/ns/hearings/testimony/cain4-30.htm

46 http://www.house.gov/reform/ns/hearings/testimony/testimonyforgreenleaf.htm

47 http://cns.miis.edu/research/cbw/pdd-62.htm

http://thomas.loc.gov, Section 511, FY 1999 National Defense Authorization Act

48 http://www.defenselink.mil/news/Aug1998/t08171998_t814ntrx.html

49 http://www4.law.cornell.edu/uscode/10/12304.text.html

50 http://cns.miis.edu/research/cbw/, Section 511, FY 1999 National Defense Authorization Act

51 Thomas Williams, "Pilots Quit Bradley Unit In Anthrax Dispute," Hartford Courant, 15 Jan 1999, available at: http://www.courant.com/news/archive

52 http://www.house.gov/reform/ns/hearings/testimony/written_testimony_of_maj.htm

53 http://www.dallasnw.quik.com/cyberella/Anthrax/refute.html

54 http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/1999/1/22/9.text.1

55 http://cns.miis.edu/research/cbw/factcbw.htm

56 http://www.defenselink.mil/news/Jan1999/m01201999_m005-99.html

57 http://www.govexec.com/features/0199/0199s2.htm

58 http://www.roa.org/legislation/R99-8.html

59 http://www.dallasnw.quik.com/cyberella/Anthrax/DoD_answ.html

60 http://www.af.mil/cgi-bin/multigate/retrieve?u=z3950r://dtics11:1024/airforce!F106849%3a926141695%3a%28cohen%20and%20anthrax%29;esn=FT%5fTEXT%20HTML%200;ct=text/html

61 http://www.house.gov/reform/ns/hearings/testimony/testimonyofzaid3-24.htm

62 http://www.af.mil/cgi-bin/multigate/retrieve?u=z3950r://dtics11:1024/news!F6872%3a926145334%3a%28anthrax%29;esn=FT%5fTEXT%20HTML%200;ct=text/html

63 http://www.hhs.gov/news/press/1999pres/990209.html

64 http://www.hopkins-id.edu/bioterror/index.html

65 http://www.hopkins-id.edu/bioterror/bioterr_17.html

66 http://www.defenselink.mil/news/Mar1999/n03101999_9903103.html

67 http://209.238.86.120/conferences/PreviousConferences/h3a.htm

68 www.house.gov/reform/ns

69 http://www.gao.gov/new.items/ns99005.pdf

70 Gary Matsumoto, Vanity Fair, May 1999, pages 82-98. No Internet access.

71 http://web2.insightmag.com/investiga/gulf5.html

72 http://www.af.mil/news/Apr1999/n19990401_990558.html

73 www.defenselink.mil/news/Mar1999/n03311999_9903317.html

74 www.aapsonline.org

http://www.oism.org/ddp

75 http://www.yahoo.com, news, 14 May 99

76 www.af.mil/news/Apr1999/n19990423_990759.html

77 http://www.house.gov/reform/ns/hearings/testimony/witnesses4-30.htm

http://www.house.gov/reform/ns/hearings/testimony/mrchan4-30.htm

78 Navy Times, 10 May 1999, editorial, page 56, www.navytimes.com

79 http://www.salonmagazine.com/health/feature/1999/05/13/anthrax/index.html

80 Thomas Williams, "Anthrax shots are resumed after Hiatus," Hartford Courant, 12 May 1999, http://www.courant.com/news/archive

81 Fort Detrick, MD; AVIP Info Brief & Slide Show Presentation Data (transcribed), by Maj. Strawder, 25-27 May 1999. http://www.dallasnw.quik.com/cyberella/Anthrax/FtDetrick5_99.html

82 http://www.cbs.com/flat/story_160341.html

83 http://www.madison.com, view article by Richard W. Jaeger, Wisconsin State Journal, 19 June 99.

84 http://www.dallasnw.quik.com/cyberella/Anthrax/Kern_summ.htm http://www.house.gov/reform/ns/hearings/testimony/new_page_6.htm

85 NEWS RELEASE for 30 June 1999 AVIP Hearings, Chairman Congressman Shays, POC - Mr. Halloran, (202) 225-2548, House Subcommittee on National Security, Veteran Affairs and International Relations, 24 June 1999. http://www.house.gov/reform/ns/hearings/testimony/statement_of_rep_630.htm

86 http://www.uniontrib.com/news/military/990629-0010_8n29anthrax.html

87 Anthrax Vaccine Firm in Trouble; Pentagon's Inoculation Program Supplier Near Bankruptcy; By Bradley Graham; Washington Post Staff Writer; Thursday, July 1, 1999; Page A2.

88 http://www.dallasnw.quik.com/cyberella/images/91Mem_gif.gif

http://www.dallasnw.quik.com/cyberella/images/91Mem2_gif.gif

http://www.dallasnw.quik.com/cyberella/images/91MemA_gif.gif

89 http://www.airforcetimes.com

90 http://www.house.gov/reform/ns/press/subcommittee_press_releases5.htm

91 Congressman Jones of NC introduces legislation to make AVIP voluntary, 16 June 99. http://thomas.loc.gov/cgi-bin/bdquery/z?d106:HR02543:@@@P

92 Congressman Gilman of NY introduces moratorium bill, http://thomas.loc.gov/cgi-bin/bdquery/z?d106:HR02548:@@@P

93 http://www.house.gov/reform/ns/hearings/testimony/july_21.htm

94 The Washington Post, p. A19, 26 July 1999.

95 http://www.courant.com/news/archive/aug13%2Dctnews16.stm

96 The Washington Post, p. A15, 14 August 1999.

97 The Washington Post, p. A15, 16 August 1999.

98 http://www.defenselink.mil/news/Aug1999/n08171999_9908176.html

99 http://www.insightmag.com/articles/story1.html#linkTOP, http://www.insightmag.com/articles/story2.html

100 Thomas Williams, Hartford Courant, 29 August 1999, page A1, http://www.courant.com/news/archive

101 Matthew Hay Brown, Hartford Courant, 17 September 1999, http://www.courant.com/news/archives

102 http://www.sftt.org/articles/shooting_straight.shtml

103 http://www.courant.com/news/special/anthrax/index.stm

104 http://www.house.gov/reform/ns/press/witness_list929.htm

105 http://www.house.gov/reform/ns/press/heemstra.htm

106 http://www.house.gov/hasc/openingstatementsandpressreleases/106thcongress/99-09-30buyer.pdf

107 http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/1999/10/1/8.text.1

108 http://www.house.gov/reform/hearings/healthcare/99.10.12/index.htm

http://www.sunspot.net/cgi-bin/editorial/story.cgi?section=archive&storyid=1150160203453

109 http://www.gulflink.osd.mil/library/randrep/pb_paper

http://www.pbs.org/newshour/bb/health/july-dec99/anthrax_10-21.html

http://www.usatoday.com/life/health/general/lhgen165.htm

http://www.usatoday.com/life/cyber/tech/ctg458.htm

110 http://www.house.gov/reform/ns/press/hear1020.htm

http://www.house.gov/hasc/testimony/106thcongress/99-10-20alibek.htm

111 www.gao.gov, Medical Readiness: DoD Faces Challenges in Implementing It's Anthrax Vaccination Immunization Program, GAO/NSIAD-00-36, October 22, 1999

112 http://www.airforcetimes.com/stories/airf23.htm

113 Email corrections or comments to: TRempfer@aol.com, http://www.dallasnw.quik.com/cyberella/Anthrax/editorial.html

Contents
Official Documents
Congressional Testimony
Position Papers
Troop Experiences
News Articles
Government Contact Information
Opinion
Informative WWW Sites
Benefit versus Risk

Last revised: March 2001