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Fwd: Pentagon Weighs Options In Anthrax Vaccine Suit

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Vaccines May Be Linked to Gulf War Syndrome


DOD to Review Possible Use of Illegal Additiveby Michael Devitt, Associate Editor Less than four months after its publication, the Department of Defense (DOD) has agreed to review a controversial study that appears to link Gulf War syndrome (GWS) with a banned substance used in experimental vaccines. The study, conducted by scientists at Tulane University Medical School, found that an overwhelming majority of sick veterans who had served in the Gulf War, and had received at least one vaccination, tested positive for antibodies to a naturally occurring substance called squalene. None of the healthy veterans in the study tested positive for squalene antibodies. DoD officials originally dismissed the study as flawed and asserted that none of the vaccines administered during the Gulf War contained squalene. In response to pressure from Congress, however, the department has asked the Armed Forces Epidemiological Board (AFEB) to re-examine the study. The Institute of

Medicine is also reviewing the research to see what role squalene may play in Gulf-related illnesses.1 Squalene Adjuvant: Friend or Foe?A naturally occurring molecule, squalene is produced by the human liver and plays a role in the metabolism of cholesterol. It is most commonly found in vegetable oils, shark liver oil, cosmetics and various health supplements. Under normal circumstances, squalene is released into the blood to help combat physical injuries. However, people don't usually have enough squalene in their blood to prompt the production of detectable levels of antibodies. Since the late 1980s, squalene has been studied by the DoD and the National Institutes of Health as a possible adjuvant in vaccines. Because adjuvants boost the immune system's response to foreign antibodies, the subtance has sparked the interest of researchers. Drug manufacturers, for their part, have incorporated adjuvants into vaccines in the belief that the substance will render the

vaccine more effective. Adjuvants, however, can sometimes trigger unwanted immune responses. While large-scale studies have yet to be conducted in humans, animal studies have shown that squalene adjuvants may generate autoimmune versions of arthritis and multiple sclerosis type-conditions that attack the body from within.2 Although they have been used in a number of vaccines worldwide, only one adjuvant - aluminum hydroxide - has been approved by the Food and Drug Administration for use in vaccines in the United States. And although squalene-adjuvant vaccines have been used on laboratory animals and in experimental human tests, the FDA has not approved the general use of any vaccine containing squalene in the U.S. "We Never Used Squalene in Vaccines"Military officials have said all along that no Gulf War vaccines contained squalene. In August 1997, spokespersons for the DoD claimed that squalene "was not an adjuvant that was in any of the vaccines that were used by

the Department of Defense,"3 and that "we never used squalene in vaccines" during the Gulf War. However, in a report4issued in March 1999, the General Accounting Office (GAD) - the investigative arm of Congress - stated: We cannot say definitively whether or not Gulf War-era veterans were given vaccines with adjuvant formulations containing squalene for a number of reasons. Although DoD officials told us they did not administer such vaccines, they stated they did not have documentation on the process and results of decision-making related to the administration of vaccines at the time of the Gulf War. Also, some officials involved in the decisions were no longer employed with DoD at the time of our review, and we were either unable to locate them, or they declined to be interviewed. A month after the GAO issued its 1999 report, the first hint that squalene might be linked to Gulf War syndrome appeared in an article in New Scientist magazine.5 Robert Garry, a virologist

at Tulane University, tested more than 400 Gulf War veterans for antibodies to squalene and found that 95 percent of those with GWS had high levels of squalene antibodies. Garry also tested a pair of volunteers who had received experimental herpes vaccines containing squalene in trials conducted by the National Institutes of Health. Both had high levels of squalene antibodies and also suffered from GWS-type symptoms. In February, the peer-reviewed journal Experimental and Molecular Pathology6 published a study written by Garry's team at Tulane University and Dr. Pamela Asa, an immunologist from Tennessee. Dr. Asa was one of the first health professionals to advance the theory that Gulf War syndrome might be an autoimmune disorder caused by experimental vaccinations. The research included blinded and unblinded studies. In the blinded study, 56 Gulf War-era veterans and military personnel who were on active service in 1990-91 were tested for squalene. Of those 56, 38

had been deployed to the Persian Gulf and had GWS-type symptoms; 12 had been deployed but were healthy; and six had not been deployed but were nevertheless ill. The researchers found that among the 38 ill veterans who had been deployed, 36 (94.7 percent) tested positive for squalene antibodies. None of the deployed healthy individuals, however, tested positive. Furthermore, all six subjects who were ill, but had not been sent to the Gulf, also had squalene antibodies. While they did not serve in the war, they had received the same type and number of vaccinations given to Gulf War troops. To see whether squalene antibodies might be a marker for other types of autoimmune diseases, the researchers also tested groups of patients with lupus and chronic fatigue syndrome, as well as a small sample from the general population. Only 15 percent of those with chronic fatigue tested positive for squalene; only 10 percent of those with lupus tested positive; and only five percent

of the general population had squalene antibodies. The Tulane study made no conclusion about whether Gulf War vaccines contained squalene, what may have produced the antibodies, or what role they play in Gulf War syndrome. Still, it is hoped that the research conducted by Garry and Asa will prompt others to investigate the role of vaccinations in Gulf War syndrome and the safety of vaccines that contain squalene. "We don't know what caused the immune system to produce anti-squalene antibodies in the Gulf War veterans, but this study shows that the antibodies are indeed there," observed Dr. Russell Wilson, president of Autoimmune Technologies, which helped market the study. Dr. Wilson does not believe that the antibodies were the result of a reaction to squalene added to vaccines. "That possibility must still be formally ruled out,"7 he concluded. Approximately 700,000 Americans served in the Gulf War between 1990-91. One hundred and forty-eight Americans were killed

in action; 467 were wounded. The Department of Veterans Affairs estimates that as many as 100,000 veterans may be suffering from Gulf War syndrome or related symptoms, and that approximately 6,500 soldiers have died since the war's conclusion, including more than 1,300 soldiers between the ages of 18-24.8

Hughes J. Scrutinizing squalene: government to review study linking gulf illness, antibodies. Associated Press, April 14, 2000.

What is squalene? Associated Press, April 14, 2000.

Rodriguez PM. The Gulf War mystery. Insight Magazine, September 8, 1997.

Gulf War Illnesses. Questions about the Presence of Squalene Antibodies in Veterans Can Be Resolved. United States General Accounting Office, March 1999.

Mackenzie D. Victims of vaccines. New Scientist April 10, 1999.

Asa PB, Cao Y, Garry R. Antibodies to squalene in Gulf War syndrome. Experimental and Molecular Pathology February 2000;68(1):55-64.

New antibodies discovered in Gulf War syndrome patients. AutoImmune Technologies (www.autoimmune.com ), January 31, 2000.

Turner A. Death ruling raises issue of Gulf War ills. Houston Chronicle April 15, 2000.



NVIC <bolor@nvic.org> wrote:

Date: Tue, 11 Jul 2006 11:05:47 -0400 (EDT)

From: NVIC <bolor@nvic.org>

To: tomcat6169@yahoo.com

Subject: [NVIC] Forced Use of Anthrax Vaccine

July 10, 2006

National Vaccine Information Center

e-Newsletter Forced Use of Anthrax Vaccine

Pentagon weighs options in anthrax vaccine suit

Time to end anthrax suit

Join our mailing list!

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BL Fisher Note:

The fate of U.S. soldiers, who refused an order to be injected with the highly reactive anthrax vaccine, is shared by both U.S. District Judge Emmet G. Sullivan and the Department of Defense (DOD). Sullivan is the federal court judge in Washington, D.C. who issued an injunction in October 2004 halting mandatory anthrax vaccination of all US military personnel without obtaining voluntary, informed consent.

In February 2006, an appellate court asked Sullivan to decide whether DOD had the legal right to order that the experimental anthrax vaccine be injected into all troops for 14 years before the FDA licensed it for use against inhalation (weaponized) anthrax in December 2005. The DOD was supposed to answer Sullivan's questions at a scheduled June 27, 2006 federal court hearing but DOD requested postponement of the hearing.

Ever since the Gulf War began in 1991, millions of US soliders have been forced to get the experimental anthrax vaccine. There have been tens of thousands of reports of brain and immune system dysfunction, including death, among soldiers following vaccination. After seeing many of their colleagues die and become crippled after anthrax vaccination, more than 400 soldiers refused the vaccine and were court martialed, dishonorably discharged or otherwise forced to leave the military. If Sullivan rules that it was unlawful for the DOD to order troops to take an experimental anthrax vaccine without their informed consent, the soliders who have been punished for refusing to take the vaccine will be able to petition DOD for correction of their service records.

In March, 2005, the National Vaccine Information Center joined with groups representing vaccine injured soldiers and filed an amicus brief in the lawsuit John Doe et al v. Donald Rumsfeld (Secretary of Defense) protesting the lack of informed consent protections in the military's mandatory anthrax vaccination program. The amicus brief specifically addressed the apparently contrived use of the Emergency Use Authorization (EUA) under Project Bioshield by the Secretaries of Health and Human Services and DOD to get around Judge Sullivan's 2004 injunction that required the DOD to give soldiers voluntary, informed consent to anthrax vaccination. The DOD and DHHS claimed an "emergency" existed which required supsension of soldiers' right to informed consent to use of an experimental vaccine or drug.

In the amicus brief, NVIC and co-signers, pointed out that "FDA's history of regulatory malfesance with respect to anthrax vaccine, combined with the emergency use provision of the 2004 Bioshield Act, create the scenario for an anthrax vaccine disaster that affects a much larger segment of the U.S. population, and not just the military."

Federal legislation passed since September 11, 2001 has set the stage for forced use of experimental vaccines and drugs in both military and civilian settings whenever the politically appointed Secretary of the Department of Health and Human Services (DHHS) declares an "emergency." There will be no recourse to appeal the emergency declaration to anyone, including the courts.. The cavalier use of the EUA by the Secretaries of DHHS and DOD in the case of forced anthrax vaccination of soldiers is a chilling example of what American citizens will face in the future.

Americans would do well to remember why the informed consent ethic is so important to fight for and protect. At the Doctor's Trial at Nuremberg after World War II, medical doctors employed by the German state were put on trial for forcing experimental medical interventions on citizens. Although those medical doctors were tried for incomparable crimes against humanity, the Nuremberg Tribunal wisely understood that the only way to deter all forms of medical exploitation of vulnerable people was to require doctors inside and outside of government to adhere to the ethical principle of voluntary, informed consent. At the trial's end, the Tribunal issued "The Nuremberg Code" to serve as a guide to the ethical practice of medicine.

Vaccination is a medical intervention performed on a healthy individual which can kill or injure that individual. Therefore, voluntary, informed consent to vaccination, in either a military or civilian setting, is a human right.

Pentagon weighs options in anthrax vaccine suit

Latest hearing pushed back at government's request

Air Force Times (Gannett) July 10, 2006

By Gayle S. Putrich Times staff writer

The question of whether the Defense Department will be allowed to resume ordering service members to take the controversial anthrax vaccine continues to drag on in court.

A status hearing, in which the judge would ask questions and hear arguments from both sides without rendering a decision, was scheduled for June 27. But that was pushed back indefinitely, sources say, at the request of the government for reasons that are unclear.

"We're just waiting," said Mark Zaid, an attorney for the six anonymous military and federal civilian plaintiffs in the suit, Doe v. Rumsfeld. "DoD needs to decide what they're going to do."

The vaccine program became voluntary in early 2004 after a federal judge halted mandatory shots because he said the vaccine was being used in an unapproved way.

After nearly two years of further study, the Food and Drug Administration issued a "final rule" in December 2005 that the anthrax vaccine is "safe and effective" as protection against both the skin and inhalation forms of the disease.

Defense officials hoped the FDA's decision would force a reversal of the earlier court order that made the shots voluntary. The Defense Department also wanted an appellate court to rule that the government was within its rights all along to order troops to take the vaccine. That request, however, was turned down.

The injunction that made the shots voluntary ended with the FDA's Dec. 19 licensing of the drug against inhalation anthrax. A three-judge panel of the D.C. District Court of Appeals agreed in a Feb. 9 decision that "the injunction is dissolved and this case no longer presents a live controversy on which we may pass judgment."

However, instead of saying that forcing troops to take the vaccine was legal all along, the panel kicked the case back to the original judge, U.S. District Judge Emmet G. Sullivan, "with instructions to the district court to consider that request."

Sullivan's decision could have an impact on hundreds, perhaps thousands, of service members who were punished for refusing an order to take the vaccine when the shots were mandatory.

If Sullivan rules that the Pentagon was within its rights to order people to take the anthrax vaccine even though it had not yet been properly licensed by the FDA, then the punishments meted out to those who refused the inoculations will stand.

If, however, it is ultimately determined that the Pentagon was wrong to have forced the shots on troops, those punished for refusing the drugs will be able to petition for the correction of their service records.

Service members are responsible for their own records; the Defense Department will not offer to update them, even if they are inaccurate. And there is a six-year statute of limitations on changing records in situations involving disciplinary action.

The Pentagon's top health affairs official, Dr. William Winkenwerder Jr., had his own take on the situation when he spoke with Air Force Times editors and reporters June 12.

He indicated the Defense Department got what it wanted from the appellate court, though he said the program will remain voluntary for now.

"The DoD appeal was not rejected," Winkenwerder insisted. "The FDA made a final decision after the federal judge had placed an injunction on the program. And the final decision from the FDA, the final rule, allows the department to use the vaccine as we would see fit. And we are reviewing our program."

He said the Pentagon has made no decision whether to continue the existing voluntary approach indefinitely or "return to a mandatory approach or change the target population that we would seek to protect."

When the status hearing finally takes place, it will be the latest step in a long legal journey that began in 1998, when the Pentagon required shots to protect troops against the possible use of anthrax as a biological weapon.

The case, which has become a tangled web of arguments about scientific research methods, complex statistics and drug safety, boils down to two questions: Is the anthrax vaccine safe, and does it work?

Government officials contend that scientific data show the series of six shots to be safe, and that they protect against all forms of anthrax, including airborne spores - the most probable form of anthrax that terrorists would use.

But opponents say the vaccine, made by a Michigan company that over the years has endured numerous financial problems and health code issues at its plant, risks making service members ill.

Hundreds of troops have complained of health problems they believe are linked to the vaccine. Despite congressional requirements that the Pentagon track the potential health risks of anthrax shots, the Daily Press of Newport News, Va., reported in December that defense officials had kept from public view reports of the hospitalization of more than 20,000 service members following anthrax vaccinations.

Defense officials contend there is no evidence that any of those hospitalizations are linked to the vaccine.

Time to end anthrax suit


Air Force Times (Gannett) July 10, 2006

A lawsuit that challenges the military's anthrax vaccine program is now well into its fourth year in court.

It's time for the Pentagon to reach out and settle the case.

The vaccine became voluntary in late 2004 when U.S. District Judge Emmet Sullivan shut down the mandatory program, ruling that the Food and Drug Administration had failed to properly license the vaccine for use against the inhalation form of anthrax.

The FDA issued a final rule certifying the vaccine for such use last December. The Pentagon then appealed not only to have Sullivan's injunction lifted, but to have the courts certify that the mandatory program had been legal all along. That's a crucial point - if the courts rule that the old program was illegal, any troops who were punished for refusing an order to take the vaccine could petition to have their records corrected.

In February, an appeals court dissolved the injunction but sent the case back to Sullivan to decide whether the mandatory program was legal.

A hearing on that issue was scheduled in Sullivan's court June 27 but was pushed back indefinitely at the government's request, without explanation.

Meanwhile, Dr. William Winkenwerder Jr., the Pentagon's top health affairs official, seems downright blasé about when, or even if, the Pentagon might reinstate mandatory shots.

"We are reviewing our program," is all he would say June 12. "No final decisions have been made."

This is a curious lack of urgency coming from an agency that, until recently, issued strong and repeated assertions about the dire nature of the anthrax threat facing U.S. troops.

Many service members, both past and present, deserve resolution to this long, tired saga. Indeed, the Defense Department itself needs to move ahead one way or another - to settle on how such matters should be handled in the future.

It's time to stop the foot-dragging and resolve this issue, once and for all.

NVIC e-newsletter is a free service of the National Vaccine Information Center and is supported through membership donations.

NVIC is funded through individual membership donations and does not receive government funding. Barbara Loe Fisher, President and Co-founder.

Learn more about vaccines, diseases and how to protect your informed consent rights http://www.nvic.org

NVIC National Vaccine Information Center


email: kathi@nvic.org

phone: 703-938-dpt3

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Unified Veterans Coalition


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