ANTHRAX VACCINE - SUMMARY OF ISSUES AND OBJECTIONS

ANTHRAX VACCINE - SUMMARY OF ISSUES AND OBJECTIONS

HEALTH AND SAFETY (6 shots in 18 mos/annual boosters=24 shots in 20 yrs)

Systemic (Major) Side-Effect Problems with the Vaccine (Requiring Shots be Discontinued)
- 5/00: Pentagon-funded British study links multiples vaccines in Gulf War (including anthrax) to
muscle pain, concentration problems, and fatigue -- similar to current reaction reports
- Vaccine Adverse Event Reporting System (1400 reports) show far more serious conditions, too
- GAO, 4/29/99: passive VAERS reaction tracking unreliable; causes serious under-reporting!
- Former FDA Director David Kessler says only 1% of reactions ever get reported
- FDA acknowledged that 90% of doctors don't report vaccine reactions
- '70s Swine flu vaccine JAMA analysis: military reports only 1/7th of the civilian rate
- Active tracking Hawaii study shows 48% systemic reactions--Nearly 250,000 times higher
than an early DOD claim of an unreal .0002%! (Manufacturer claims .2% systemic rates)
- Korea study: overall reaction rates ~twice as high for women (74%) vs men (38%)
- GAO report NSIAD-99-5: vaccine may contain a non-FDA-approved adjuvant called squalene
- DOD policy illegally continues shots after systemic effects in violation of FDA-approved label
- Documented cases of DOD administering shots from expired lots with serious health impacts
- February 2000 Institute of Medicine Report indicates insufficient data exists to determine safety

FDA Approval Process, Inspection Reports, Warning Letters and Lack of Program Review
- 5/00: FDA refuses to release ~1 million doses because of safety and efficacy problems!
- 11/99: Vaccine plant fails FDA inspection for the fourth time, many repeat violations
- Scathing 2/98 FDA 100 page report on vaccine-84 quality control & procedure violations!
- 25 of 31 lots fail flawed retest; vast inventory (5 million+ doses) still in quarantine!
- FDA Warning Letters sent to the manufacturer in 1995 & 1997 (threatened to revoke license)
- SECDEF-chosen program reviewer had no anthrax/vaccine expertise; advised on marketing
- GAO findings: FDA never evaluated new anthrax strain, new adjuvant, manufacturing changes,
or efficacy data; need for 6 initial shots/annual boosters unsubstantiated
- FDA removed rotavirus, seldane, and phen-fen for far less; why is this vaccine still on market?

Disturbing Similarities of Anthrax Vaccine to Government Swine Flu Vaccine Mistakes in '70s
- 1 swine flu-related death scared gov't because 450,000 died of it in WWI, but 0 anthrax deaths;
- In both cases, antibiotics use de-emphasized;
- probability and severity of occurrence not predictable, incalculable risk portrayed as inevitable risk;
- no reactions anticipated, but field trials showed poor efficacy/many reactions (Harvard JFK School of Govt Case Analysis)
- 46 million shots given; 3 Swine Flu Vaccine deaths halted program; 4,000 nerve damage claims

AN ARBITRARILY MAGNIFIED THREAT
- October '95 DOD meeting indicated a need to "make the case" for anthrax as the top BW threat
- Conclusions of recent Congressional hearings, reports and book publications on biowarfare
- threat unchanged in 10 yrs; attack probability overstated; bioweapons very difficult to manage
- Japan Sarin terrorists had 4 yrs, funds & expertise--no successful anthrax attacks in 8 tries!
- NY Times reports both the President and Secretary of Defense influenced by biowarfare fiction
- Serious biodefense: working detectors/suits/training/masks/filters/antibiotics/decontamination

INEFFECTIVE VACCINE
-USSR & US biowarfare experts Ken Alibek & Bill Patrick say vaccines are easily defeated
- Vaccines could never keep up with anthrax permutations, other biological agents
- Manufacturer even has application in to FDA for better proof of efficacy; FDA denying request
- Large 1998 Army mice and guinea pig studies show 90% failure rate against multiple strains
- Small monkey/rabbit trials with 90%+ survival against one strain are used to justify the vaccine
- Journal of the American Medical Association: data is lacking for inhalation efficacy claim
- Senate Staff Report 103-07 says efficacy against inhaled anthrax is "unknown".

VIRTUALLY NO PUBLIC SUPPORT FOR THE PROGRAM
- Spring 2000 AOL Poll, 83% of those surveyed AGAINST the program (6700 participants)
- 2/18/00 CNN Talk Back Live online query, 85% OPPOSED to the the AVIP program
- 9/99 USA Weekend questionnaire: 83% again AGAINST the program (8000 participants)
- 5/99 Army Times Publishing Company poll -- 77% AGAINST! (military respondents)
- 2/99 TalkSpot KOVR Radio Survey shows 90% of respondents AGAINST the program!
- Statements of Caution/Opposition by Groups representing over 2 million (est) Americans:
Association of American Physicians and Surgeons, Doctors for Disaster Preparedness, ROA,
American Legion, American Public Health Association, Air Force Sergeants Association,
Family Research Council, Soldiers for the Truth, Association of Civilian Technicians, others.

LEGAL, POLICY, and LOGIC PROBLEMS
- 2 AF Reserve JAGs brief: policy is illegal and based on non-enforceable DOD/FDA memo
- Senate Staff Report 103-97: vaccine still considered experimental, may be cause of GWS
- DOD Threat Reduction Agency and State Department -- more risk, but voluntary shots!
- Forced shots are forcing commanders to play doctor and doctors to play commander
- Pentagon/Congress are terrorist targets without detection devices; why are they unvaccinated?
- Khobar Towers/Kosovo message: Combat casualties not acceptable; vaccine casualties OK!
- Vaccine is a loyalty test; death by flu more likely, but no punishment for skipping a flu shot

INTERNATIONAL IMPACTS AND EXPERIENCE OF ALLIES
- Erodes '72 BW Convention; encourages BW arms race; de-emphasizes massive retaliation
- French: Didn't vaccinate in the Gulf War; their military members don't have Gulf Syndrome
- British: Admit mistakes in Gulf; offered a voluntary vaccine; 73% declined; program stopped
- Israelis: Don't have a mandatory vaccine policy either; relying on antibiotics
- Canadians: Had mandatory vaccine; recent anthrax vaccine refuser court martial thrown out

BAD REACTIONS AND IMPACTS ON THE GUARD AND RESERVE
- Reservists couldn't get records, diagnosis, or treatment of vaccine side-effects from Gulf War
- Reserve members experiencing similar side effects and significant obstacles to treatment
- Health risks jeopardize civilian income; reservists can't afford vaccine side-effects!

FAMILY, PERSONAL AND WOMEN'S ISSUES (No vaccination if pregnant)
- Military family members, relatives, friends outraged; many perceive as assault; way too risky
- Everyone is vaccinated with almost total disregard for medical conditions or drug interactions
- Some experts advise against vaccinating while nursing; GAO: women studies are non-existent
- 3 Congresswomen warned SECDEF & HHS of consequences for women of child-bearing age

MILITARY AND CIVILIAN PILOT OBJECTIONS/ISSUES
- Commercial pilots in Guard/Reserve units faced with taking the shot conduct serious research
- Between 25-100% aircrew (1000+) refused the shot or plan to based on discoveries
- Documented reactions could cause pilots serious problems & risk passenger safety
- Senior aircrew may retire from military; loss of leadership (5000 flying hours, instructor pilots)
- Younger pilots may just quit the military; won't risk $M airline careers for a risky vaccine

LIMITATION ON FREEDOM OF RELIGION
- Policy only allows religious objection based on any church doctrine against ALL vaccines
- No religion, except self-destructive cults, approves of injecting questionable substances
- National survival is not dependent on disallowing religious objections to this vaccine!

CONGRESSIONAL INTEREST AND OPPOSITION GROWING
- Senate/House Armed Services Committees hearings: restricting FY 2001 funds for program
- At least 11 hearings in 1999 on vaccine related issues--5 hearings on this vaccine resulted in
House Gov't Reform Committee 2/17/00 report recommending suspension of the program
- 5/14/00 letter to SECDEF by 34 representatives demanding immediate program halt
- 11/3/99 Congressional letter to FDA: vaccine should be put back in experimental status
- 7/20/99 Congressional letter to SECDEF states conditions for implementing program not met
- BIOPORT now under criminal investigation; result of an audit request by Rep Jones (NC)
- Bioport management abilities questioned at the Congressional hearing on 6/30/99
- Business valuation, DCAA audits, DOD IG show horrid financial mismanagement
- DOD disregarded concerns; awarded $19M (3X requested $) to bail out Bioport, 8/99
- After 11/99 FDA inspection failure, DOD planned another plant $7-10M infusion
- DOD now plans $2.5M/month indefinite bailout!

VACCINE PROFITS AND BUDGET CONSIDERATIONS
- WSJ reports vaccine market potential increased with recent tax, patent and litigation changes
- Newer/better vaccines and drugs often not developed quickly because they are less profitable
- Administration BW vaccine stockpile decision included those who would gain financially
- Insider trading in sale of supplier to Bioport (Adm Crowe); lawsuit dismissed, facts undisputed
- Budget Black Hole: $.25 Billion Previous/Current + Future Indemnification Claims + Pilot Replacements + avoidable health care, judicial actions, lost productivity, recruiting expenditures

CIVILIAN ISSUES AND IMPLICATIONS FOR THE FUTURE
- 1999: 50+ home grown anthrax hoaxes across country cost $millions, affected 13,000, so far
- Administration officials: current vaccine not for civilians, but CDC plans BW vaccine stockpile
- '97 DOD letter to FDA considers circumventing informed consent for civilians
- Hearings show FDA abdicating responsibility, reviewers with investments, conflicts of interest
- Anthrax vaccine alone more than doubles # of shots military members receive in a career!
- $322M budgeted now to develop new biowarfare vaccines; > 15 initially; potential for 50+
- DOD also studying lab workers who have already received 150-300 shots of various types!
- Huge health risk potential while we're still spending $134M for 145 projects to solve GWS
- Where is all this leading? What are limits on the body, recruiting, retention, fitness and morale?

DOD PRIOR KNOWLEDGE AND IRRATIONAL COMMITMENT
- This issue began as US BW agent sales to Iraq in '80s for "research" which turned into a threat
- Early '90s news articles identify same issues of informed consent violations, safety and efficacy
- 10/20/95 & 2/9/94 DOD meetings discovered all major vaccine problems discussed here!
- DOD indemnification document portrays ineffective vaccine; may cause severe reactions!
- DOD intends to pursue the anthrax vaccine at all costs once Bioport FDA approval obtained

CONCLUSIONS
- Government fear-mongering leads to irrational policies and irresponsible, even criminal actions
- Congressman Shays: The anthrax vaccine program represents "Malpractice and Malfeasance"
- FDA and DOD pencil-whipped approval/implementation review to expedite use of old vaccine
- Personal FDA memo does not affect legal vaccine status as unapproved for airborne anthrax
- DOD's use of the vaccine thus constitutes experimentation; forced shots not a lawful order
- Many disturbing issues; many unanswered questions; many indications of DOD callousness
- Solution: Stop the program before service members and national defense suffer further.

For more information contact:

The National Organization Of Americans Battling Unnecessary Servicemember Endangerment

NO ABUSE
P. O. Box 70186, Washington, D. C., 20024
202-554-4477
email: kernlhandy@aol.com

Sources researched for this paper include:

1. DOD documents obtained under a Freedom of Information Act Lawsuit filed by the Veteran's for Integrity in Government and from a Ft Detrick 5/99 anthrax vaccine meeting
2. Harvard University's JFK School of Government Case Study on the Swine Flu Vaccine
3. GAO Report # NSIAD-99-5 and 99-148-March & April 1999
4. Original documents on a website established by parents concerned about reactions their children in the service were experiencing from the shot--http://www.dallasnw.quik.com/cyberella/
5. Congressional Testimony: www.house.gov/reform/ns/hearings
6. New York Times, "Once He Devised Germ Weapons; Now He Defends Against Them," 11/3/98
7. Journal of the American Medical Association Articles-Vol 278, #5, p. 402; Vol 275 #3, pp. 241-243
8. DOD Website information and hand-out literature
9. Vanity Fair, Gary Matsumoto, The Pentagon's Toxic Secret, May 1999, p. 82
10. Washington Post Sunday Magazine, Arthur Allen, "Shots in the Dark," 8/30/98, p. 11.
11. Gulf War Veterans Website-gulfwarvets.com/
12. Perspectives Magazine, Conrad Istock, "Bad Medicine," Nov/Dec 1998, p. 21.
13. Dayton Daily News, K.M. Severyn, Ph.D, oncerned Parents Unfairly Shut Out of Congressional Hearings on Vaccines," 5/28/93, p. 15A.
14. Nature Magazine, 11/97, p.3.
15. Montreal Gazette, "Military Out of Anthrax Vaccine for gulf Veterans," 1/22/99, p. 6.
16. Israel Defense Website on biological weapons-www.webinterview.com/documents/ISREAL0001.htm
17. Conversations with Guard and Reserve members.
18. The Washington Post, Daniel S. Greenberg, "The Bioterrorism Panic," 3/16/99, p. A21.
19. Air Force News Website-www.af.mil/news/April1999/n1999040*1_990558.html.
20. New York Times, William Broad and Judith Miller, "Clinton Seeks More Money to Counter Germ Warfare," 6-9-98.
21. Dallas Morning News, Jim Landers, "U. S. Quietly Upgrading Homeland Defense Plan," 2/9/99.
22. Wall St Journal, Elsye Tanouye, "The Vaccine Business Gets a Shot in the Arm," 2/25/98.
23. State of Michigan, 30th Judicial Circuit Court Case, Docket No. 98-17098-CM.
24. New York Times, William Broad and Judith Miller, "Germ Defense Plan in Peril as Its Flaws are Revealed 8-7-98.
25. New York Times, William Broad and Judith Miller, "The Threat of Germ Weapons is Rising. Fear, Too," 12/27/98.
26. Washington Post, David Brown, "The $115 Million Question," 11/23/98, p. 15.
27. Army Times, Patrick B. Pexton, "A Promise To Do Better Is Not Enough," 2/2/98, p. 50.
28. JAMA, Vol 281: pp. 1735-1745.
29. http://www.salon.com/health/feature/1999/05/13/anthrax/index1.html.
30. Bangor Daily News, Ruth-Ellen Cohen, "The Anthrax Vaccine," February, 12, 2000.
31. Letter to SECDEF on AVIP signed by Representatives Gilman, Kelly, Ose, Shays, Souder and Talent, 7/20/99.
32. Secretary of the Army Memorandum of Decision, dated Sept 3, 1998, Subject: Authority Under Public Law 85-804 to include an Indemnification Clause in Contract DAMD17-91-C-1139 with Michigan Biologic Products Institute
33. Money Magazine, Andrea Rock, "The Lethal Dangers Of The Billion-Dollar Vaccine Business," 12/96, Vol. 25, No. 12.
34. Washington Post, Leonard A. Cole, "A Plague of Publicity," 8/16/99; p. A15.
35. Washington Post, Milton Leitenberg, "False Alarm,"8/14/99; p. A15.
36. Nov '99 FDA Inspection Report on Bioport facility.
37. Department of Defense comments on the 7/31/97 Federal Register notice soliciting comments on the Interim Final Rule of 12/21/90, authorizing the Commissioner of Food and Drugs to determine that obtaining informed consent for the use investigational new drugs in certain military combat exigencies is not feasible.
38. Boston Globe, Jeanne Guillemin, "Scare Campaign About Biological Weapons Is Itself A Threat," 12/02/99, p. A27.
39. First Annual Report to the President and Congress of the Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass Destruction, 12/15/99, pp. 22-26.
40. The Biology of Doom, Ed Regis, 1999.
41. Biohazard, Ken Alibek, 1999.
43. U. S. Department of State Fact Sheet on Chemical - Biological Warfare, travel.state.gov/cbw.html.
44. Journal of the American Medical Association, 6/2/93, p. 2765.
45. ABC's 20/20 program transcript (1/26/90).
46. Reuters online Health report, 5/18/00.
47. Washington Post, 1/29/91, "Army Faulted on Germ War Research," p. A17.
48. Washington Post, Jeffrey Smith, "U. S. Troops to Get Germ War Vaccines," 12/29/90, Page A16.
49. Washington Post, Curt Suplee, "FDA Consents To Use Of Unapproved Drugs On U.S. Desert Troops," 12/22/90, p. A10.
50. Washington Post, David B. Ottaway, "U. S. Gave Iraq Bacteria, Sen. McCain Charges," 1/26/89, p. A16.

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

Last revised: September 2000