OBJECTIONS AND ISSUES

The Defense Department's Plan (In Process) To Vaccinate All 2.5 Million
Service Members Against The Threat Of An Anthrax Attack

HEALTH AND SAFETY (Program requires 6 shots in 18 months and annual boosters)

Systemic (Major) Side-Effect Problems with the Vaccine (Requiring Shots be Discontinued)

• Documented reactions to the anthrax vaccine from the FDA's Vaccine Adverse  Event Reporting System include nearly 50 different types of major side effects!
• Vast DOD under-reporting of major side effect problems is a virtual certainty.
  --Former FDA Director David Kessler says only 10% of reactions ever get reported.
  --70's Swine flu vaccine analysis showed military reports only 1/7th of that 10% rate.
• Army's studies show up to a 1.77% systemic rate (44,500 service members could be affected).
  --~9X the manufacturer's claim and ~9000X higher than some current DOD claims!
• Documented cases of DOD continuing shots after major reactions--violates vaccine instructions.
• Documented cases of DOD administering shots from expired lots with serious health impacts.

Relevant Gulf War Illness Information

• Senate Staff Report 103-97 - vaccine still not eliminated as a cause of Gulf War Syndrome.
• DOD refuses GAO demand to confirm a toxic, non-approved substance in the vaccine.

FDA Approval Process, Inspections Reports, Warning Letters and Lack of SECDEF Review

• GAO testimony on April 29, 1999 revealed FDA improperly approved current vaccine.
• Approved in 1970--2 years before FDA began requiring vaccine efficacy demonstrations.
  --This vaccine would not be approved using today's FDA standards!
• FDA Warning Letters sent to the manufacturer in 1995 & 1997 (threatened to revoke license).
• FDA wrote scathing 98 report on this vaccine--84 quality control & procedure violations!
• Initially, 22 of 30 lots failed retest; vast majority of vaccine still in quarantine!
• The plant is now shut down for renovation, but DOD is still using the current vaccine supply!
• Congressional hearing confirmed a condition to conduct a complete review was not fulfilled.
  --Program reviewer had no anthrax expertise, so he made marketing suggestions.

Disturbing Similarities of Anthrax Vaccine to Government Swine Flu Vaccine Mistakes in 70's

• 1 Ft Dix swine flu death caused scare because of 1918-19 pandemic (450,000 died).
• 0 weaponized anthrax deaths; DOD claims 10 countries possess anthrax, but this is not news.
• In both cases, the absolute necessity to use antibiotics was de-emphasized.
• In both cases, probability and severity of occurrence could not be predicted.
• in both cases, the government changed incalculable risk to "not if, but when"--100% probability.
• In both cases, no serious side effects anticipated, even though neither vaccine adequately tested.
• In both cases, field trials yielded depressing efficacy results and many adverse reactions.
• Swine flu program vaccinated 2X as many as ever before for a single season virus.
  --(2.5 million military receiving anthrax vaccine is 17X as many as in the Gulf War).
• 3 Swine Flu Vaccine deaths + severe reactions halted program; 4,00 nerve damage claims.
• Anthrax Vaccine results so far: 6 hospitalizations--2 life threatening heart stoppages!

VACCINE EFFECTIVENESS

Vaccines are Useless Against Bioterrorist Threats

• Foremost expert on germ warfare has no confidence in vaccines as a defense.
• Vaccine could never keep up with the possible anthrax permutations, variations of other biological agents, combinations of agents, stronger doses, and genetically-engineered germs.

Anthrax Vaccine Already Proven Ineffective By The DOD's Own Tests

• 1998 Ft Detrick study showed vaccine failed to provide unit effectiveness survival rates of 50%.
  --27 of 33 different anthrax isolates defeated vaccinated guinea pigs-- 82% failure rate!
  --Similar mice studies indicate a 90-100% failure rate for this vaccine.
• DOD basing use of the vaccine on rhesus monkey and rabbit trials showing 90%+ survival.
  --DOD states guinea pig and mice studies are less relevant.
• Guinea pig and mice studies used for a myriad of medical assessments--can't just be discarded.
• Journal of the American Medical Association says data is lacking for inhalation efficacy claim.
• Senate Staff Report 103-97 says efficacy against inhaled anthrax is "unknown".
• Recent GAO testimony on April 29, 99 in Congress reconfirmed serious efficacy questions.

INTERNATIONAL EFFECTS AND ALLIES EXPERIENCE

• Vaccine policy erodes 1972 Biological Weapons Convention; encourages biological arms race
• De-emphasizes massive retaliation response threat which worked in Desert Storm
• 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 policy: recently stopped because of supplies/controversy

SUPPORT FOR THE PROGRAM

• U.S. Talk Spot Radio Program Survey shows 83% of the public is AGAINST the program!
• Army Times Publishing Company poll showed 77% AGAINST!(more military respondents)

CONGRESSIONAL INTEREST

• Current hearings held by Subcommittee on National Security, Vet Affairs and Int'l Relations
• 4 hearings scheduled, 2 complete, June 30 will examine the DOD/manufacturer relationship
• Fall hearing will be on doctrinal problems in dealing with bioterrorism
• 3 Congressmen have written DOD requesting program delays and further analysis

REACTIONS AND IMPACTS ON THE GUARD AND RESERVE

• Reservists couldn't get accurate diagnosis or treatment of vaccine side-effects from Gulf War
• Thousands of Gulf War shot records were lost or did even not reflect shots were administered
• Health risks jeopardize civilian income; reservists can't afford vaccine side-effects!

PERSONAL, FAMILY AND WOMEN'S ISSUES(pregnancy is cause for not vaccinating)

• Service members concerned about what they might pass on to nursing babies or future children
• Women concerned they can't start a family during 18 month initial shot series
• Why are pregnant service members not returned to the U.S. if they're "exposed" without shots?
• Everyone is given the vaccine regardless of individual medical conditions or drug interactions

MILITARY AND CIVILIAN PILOT OBJECTIONS/ISSUES

• Each Guard and Reserve unit pilots faced with shot conduct serious research
  -So far, between 1/3 to 3/4 of unit pilots consider refusing the shot;
  -Some documented reactions could cause potentially serious flying problems
• Senior aircrew may be inclined to retire; loss of leadership (5000 flying hours, instructor pilots)
• Younger pilots have less to lose with the military; a lot to lose when just signing on with airline
• Policy is creating tension in units; increases turnovers

CIVILIAN ISSUES

• 50+ anthrax hoaxes across country in last several months;little progress on catching anyone
• Administration official has said "Vaccinating civilians is another thing entirely and we don't think we want to do that with the vaccines currently available." No confidence?
• DOD now accelerating vaccinations to DOD civilians and contractors some suspect because the shelf life on numerous lots is about to expire; vaccine must be used; no increase in actual threat

LIMITATION ON FREEDOM OF RELIGION

• Policy allows religious objection based on recognized church doctrine against ALL vaccines
• No religion, except self-destructive cults, would approve injecting questionable substances
• National survival is not dependent on avoiding religious objections to this vaccine!

FINANCIAL INTERESTS IN VACCINES WARRANT FURTHER INVESTIGATION

• Vaccine market potential increased with recent tax, patent and litigation changes
• Corruption allegations over vaccine plant sale; Michigan lawmakers filed lawsuit
• Administration meeting on vaccine stockpiling plan included those who would gain financially

IMPLICATIONS FOR THE FUTURE

• $322M budgeted to develop a new biowarfare vaccine;>12 planned; potential for 50 others
• All this while we are still spending $115M for 121 studies to solve Gulf War Syndrome
• Anthrax vaccine alone more than doubles the shots a member may receive in a career
  --Where is the limit to what the body can stand?
  --What are the recruiting, retention, fitness and morale impacts?
• DOD has requested FDA waivers in handling civilian disasters; wants greater involvement
  --Plans to use some of the same experimental drugs and vaccines used in the Gulf War
  --Seeking broad authority to waive monitoring and informed consent requirements

CONCLUSION

• Many disturbing issues; many unanswered questions
• With improper FDA approval and lack of a SECDEF-promised DOD program review, the anthrax vaccine program appears too experimental and thus in violation of Nuremberg Code
• This forced vaccine cannot be considered a legitimate lawful order for military members!
• The program should stop before our service members and our national defense suffers further.

To help stop this harmful waste of taxpayer money most immediately, contact:
The House Armed Services Committee 2120 Rayburn House Office Building
Washington, D.C. 20515 (202) 225-4151 http://www.house.gov/hasc/

IMPORTANT NOTE: THE WEBSITE LISTS INDIVIDUAL COMMITTEE MEMBERS, WHO COULD BE CONTACTED INDIVIDUALLY BY JUNE 15, 1999 TO AFFECT THE CURRENT DEFENSE AUTHORIZATION BILL.

PLEASE REQUEST LANGUAGE IN THE BILL FOR A PROGRAM MORATORIUM

To make a tax deductible contribution to an Anthrax Vaccine Public Awareness Fund and/or a Fund to Defend Anthrax Vaccine Refusers contact: The James Madison Project 1501 M Street, N.W. Suite 1175 Washington, D.C. 20005 E-mail: JaMadPro@aol.com

For more information contact: Government and Business Consulting 927 6th St. SW
Washington, D.C. 20024 E-mail: kernlhandy@aol.com

Sources researched for this paper include: 1. Information from thousands of pages DOD documents obtained under a Freedom of Information Act Lawsuit filed by the Veteran's for Integrity in Government 2. Harvard University's JFK School of Government Case Study on the Swine Flu Vaccine 3. GAO Report #NSIAD-99-dated March 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 available at http://www.house.gov/reform/ns/hearings/subcommittee_hearing_testimony2.htm   6. New York Times, November 3, 1998-Article titled, "Once He Devised Germ Weapons;Now He Defends Against Them" 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, May 1999 article on Squalene adjuvant found in service members blood 10. Washington Post Sunday Magazine, 8-30-98 article titled "Shots in the Dark" 11. Gulf War Veterans Website- http://www.gulfwarvets.com   12. Perspectives Magazine, Nov/Dec 1998 article titled, "Bad Medicine" 13. Dayton Daily News, May 28,1993-Article by Severyn, K.M., Ph.D. 14. Nature Magazine, Nov.1997, p. 3. 15. Montreal Gazette, 1-22-99, p.6 16. Israel Defense Website on biological weapons- http://www.webinterview.com/documents/ISREAL0001.htm   17. Conversations with Guard and Reserve members 18. The Washington Post, 3-16-99, p.A21, The Bioterrorism Panic" 19. Air Force News Website Article on Expanding the Program- http://www.af.mil/news/April1999/n1999040*1_990558.html   20. New York Times, 6-9-98, Article by Judith Miller titled, "Clinton Seeks More Money to Counter Germ Warfare" 21. Dallas Morning News, 2-9-99, Jim Landers article titled, "U.S. Quietly Upgrading Homeland Defense Plan" 22. Wall St. Journal, 2-25-98, Article by Elsye Tanouye titled, "The Vaccine Business Gets a Shot in the Arm" 23. State of Michigan, 30th Judicial Circuit Court Case, Docket No. 98-17098-CM 24. New York Times, 8-7-98, Article by William Broad and Judith Miller titled, "Germ Defense Plan in Peril as Its Flaws are Revealed 25. New York Times, 12-27-98, Article by William Broad and Judith Miller titles, "The Threat of Germ Weapons is Rising, Fear Too" 26. Washington Post, November 23, 1998, p. 15, article by David Brown Titled, "The 115 Million Question" 27. Army Times, 2-3-98, p.50, article by the managing editor, Patrick B. Pexton titled, "A Promise To Do Better Is Not Enough"

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